UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


Form 10-K


(Mark One)

TANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
 For the fiscal year ended December 31 2017, 2023
or

or

 
£TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934
 
 
For the transition period from_________to_________


Commission file number 0-15327


CytRx000-15327

LadRx Corporation

(Exact name of Registrant as specified in its charter)


Delaware58-1642740
(State or other jurisdiction of(I.R.S. Employer
incorporation or organization)Identification No.)
11726 San Vicente Blvd, Suite 650,
Los Angeles, California90049
(Address of principal executive offices)(Zip Code)

Registrant's

Registrant’s telephone number, including area code: (310)826-5648


________________

N/A/

(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuantRegistered Pursuant to Section 12(b) of the Act:


Title of each className of exchange on which registered
Common Stock, $0.001 par value per shareThe NASDAQ Capital Market
Series A Junior Participating Preferred Stock Purchase RightsThe NASDAQ Capital Market

None

Securities Registered Pursuant to Section 12(g) of the Act:

None

Title of each classTrading Symbol(s)Name of exchange on which registered
Common Stock, $0.001 par value per shareLADXOTC Markets
Series B Junior Participating Preferred Stock Purchase Rights

Indicate by check mark if the Registrant is a well-known seasoned issuer (as defined in Securities Act Rule 405). Yes £NoR


Indicate by check mark if the Registrantregistrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934. Yes £NoR


Indicate by check mark whether the Registrantregistrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months and (2) has been subject to such filing requirements for the past 90 days. YesR No £


Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). YesR No £


Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the Registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. R

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of "large“large accelerated filer," "accelerated filer"” “accelerated filer”, "smaller“smaller reporting company"company” and "emerging“emerging growth company"company” in Rule 12b-2 of the Exchange Act. (Check one):


Large accelerated filer £
Accelerated filer R
Non-accelerated filer£
Smaller reporting company £
 (Do not check if a smaller reporting company)
Emerging growth company £

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. £


Indicate by check mark whether the Registrantregistrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes £ No R


Based on the closing price of the Registrant'sregistrant’s common stock as reported on The NASDAQ Capital Market,the OTC Markets, the aggregate market value of the Registrant'sregistrant’s common stock held by non-affiliates on June 30, 20172023 (the last business day of the Registrant'sregistrant’s most recently completed second fiscal quarter) was approximately $94.5$1.1 million. Shares of common stock held by directors and executive officers and any ten percent or greater stockholders and their respective affiliates have been excluded from this calculation, because such stockholders may be deemed to be "affiliates"“affiliates” of the Registrant.registrant. This is not necessarily determinative of affiliate status for other purposes.

The number of outstanding shares of the Registrant'sregistrant’s common stock as of March 16, 201829, 2024 was 28,037,501.495,092 shares.







CYTRX

LADRX CORPORATION

2017

2023 ANNUAL REPORT ON FORM 10-K


TABLE OF CONTENTS


Page
  
NOTE ON FORWARD-LOOKING STATEMENTS23
PART I4
Item 1. BUSINESS4
Item 1A. RISK FACTORS11 20
Item 1B. UNRESOLVED STAFF COMMENTS23 41

Item 1C. CYBERSECURITY

41
Item 2. PROPERTIES23 42
Item 3. LEGAL PROCEEDINGS24 42
Item 4. MINE SAFETY DISCLOSURES25 42
PART II43
Item 5. MARKET FOR REGISTRANT'SREGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES26 43
Item 6. SELECTED FINANCIAL DATA[RESERVED]27 44
Item 7. MANAGEMENT'SMANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS29 44
Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK38 53
Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA38 53
Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE38 53
Item 9A. CONTROLS AND PROCEDURES38 53
Item 9B. OTHER INFORMATION40 54
PART IIIItem 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS54
PART III54
Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE41 54
Item 11. EXECUTIVE COMPENSATION48 58
Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS61 63
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE62 64
Item 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES63 65
PART IV66
Item 15. EXHIBITSEXHIBIT AND FINANCIAL STATEMENT SCHEDULES64 66
Item 16. FORM 10-K SUMMARY68 69
 SIGNATURES
                           70
SIGNATURES70

2
 
CytRx 2017 10-K Page #i#

NOTE ON FORWARD-LOOKING STATEMENTS

References throughout this Annual Report on Form 10-K (the “Annual Report”), the "Company," "CytRx," "we," "us,"“Company,” “LadRx,” “we,” “us,” and "our,"“our,” except where the context requires otherwise, refer to CytRxLadRx Corporation.

If we are not successful in negotiating an agreement with a strategic partner to advance at least one lead compound from our Freiburg operations, we may reduce our headcount and discontinue certain development programs and drug discovery activities. For these reasons and others, our operating results may fluctuate from period to period, and the results of prior periods should not be relied upon as predictive of the results in future periods. Furthermore, if we obtain marketing approval and successfully commercialize aldoxorubicin, or another product candidate, we anticipate it will take a minimum of two years, and likely longer, for us to generate significant recurring revenue, and we will be dependent on future financing until such time, if ever, as we can generate significant recurring revenue. We have no commitments from third parties to provide us with any additional financing, and we may not be able to obtain future financing on favorable terms, or at all. Failure to obtain adequate financing would adversely affect our ability to operate as a going concern. If we raise additional funds by issuing equity securities, dilution to stockholders may result and new investors could have rights superior to holders of the shares issued in this offering. In addition, debt financing, if available, may include restrictive covenants. If adequate funds are not available to us, we may have to liquidate some or all of our assets or to delay or reduce the scope of or eliminate some portion or all of our development programs or clinical trials. We also may have to license to other companies our product candidates or technologies that we would prefer to develop and commercialize ourselves.
References throughout this Annual Report on Form 10-K, the "Company," "CytRx," "we," "us," and "our," except where the context requires otherwise, refer to CytRx Corporation.

Some of the information contained in this Annual Report may include forward-looking statements that reflect our current views with respect to our research and development activities, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words "expect," "intend," "plan," "believe," "project," "estimate," "may," "should," "anticipate," "will"“expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward-looking statements for purposes of the federal securities laws or otherwise.

All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth in the sections entitled "Business," "Risk“Business,” “Risk Factors," "Legal” “Legal Proceedings," "Management's” “Management’s Discussion and Analysis of Financial Condition and Results of Operations," "Quantitative” “Quantitative and Qualitative Disclosures About Market Risk"Risk” and "Controls“Controls and Procedures"Procedures” in this Annual Report, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this Annual Report. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.

If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note.

INDUSTRY DATA

Unless otherwise indicated, information contained in this Annual Report concerning our industry, including our general expectations and market opportunity, is based on information from our own management estimates and research, as well as from industry and general publications and research, surveys and studies conducted by third parties. Management estimates are derived from publicly available information, our knowledge of our industry and assumptions based on such information and knowledge, which we believe to be reasonable. In addition, assumptions and estimates of our and our industry'sindustry’s future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described below in the "Risk Factors"“Risk Factors” section of this Annual Report. These and other factors could cause our future performance to differ materially from our assumptions and estimates.

TRADEMARKS

CytRx is one

LadRx, LADR and ACDx are some of our trademarks used in this Annual Report. This Annual Report also includes trademarks, trade names and service marks that are the property of other organizations. Solely for convenience, trademarks and trade names referred to in this Annual Report sometimes appear without the ® and ™ symbols, but those references are not intended to indicate that we will not assert, to the fullest extent under applicable law, our rights, or that the applicable owner will not assert its rights, to these trademarks and trade names.

3
CytRx 2017 10-K Page #ii#

PART I


Item 1. BUSINESS

COMPANY OVERVIEW

We are

LadRx Corporation (“LadRx” the “Company”, “we”, “us”, or “our”) is a biopharmaceutical research and development company specializing in oncology. OurThe Company’s focus is on the discovery, research and clinical development of novel anti-cancer drug candidates that employ novel linker technologies that target chemotherapeutic drugs to enhance the accumulationsolid tumors and release of cytotoxic anti-cancer agents at the tumor. Since 2008, we have worked to develop aldoxorubicin. In Julyreduce off-target toxicities. During 2017, we entered into an exclusive worldwide license under which NantCell, Inc. took over development of aldoxorubicin, invested in our common stock and agreed to make future milestone and royalty payments upon the successful development and commercialization of aldoxorubicin.  We are now actively pursuing new anti-cancer compounds through our drugLadRx’s discovery and research operation at our laboratory facilities in Freiburg, Germany, led by Felix Kratz, Ph.D.synthesized and tested over 75 rationally designed drug conjugates with highly potent anti-cancer payloads, culminating in the creation of two distinct classes of compounds. Four lead candidates (LADR 7 through LADR-10) were selected based on in vitro and animal studies in several different cancer models, stability, and manufacturing feasibility. In addition, a novel companion diagnostic, ACDx™, Vice Presidentwas developed to identify patients with cancer who are most likely to benefit from treatment with these drug candidates.

On June 1, 2018, the Company launched Centurion BioPharma Corporation (“Centurion”), a wholly-owned private subsidiary, and transferred to Centurion all of its assets, liabilities and personnel associated with the laboratory operations in Freiburg, Germany. In connection with said transfer, the Company and Centurion entered into a Management Services Agreement whereby the Company agreed to render advisory, consulting, financial and administrative services to Centurion, for which Centurion shall reimburse the Company for the cost of such services plus a 5% service charge. On December 21, 2018, LadRx announced that Centurion had concluded the pre-clinical phase of development for its four LADR™ (Linker Activated Drug DiscoveryRelease) drug candidates, and inventorfor its albumin companion diagnostic (ACDx™). As a result of aldoxorubicin.

completing this work, operations taking place at the pre-clinical laboratory in Freiburg, Germany were no longer needed and, accordingly, the lab was closed at the end of January 2019.

On March 9, 2022, Centurion merged with and into LadRx, with LadRx absorbing all of Centurion’s assets and continuing after the merger as the surviving entity (the “Merger”). The Merger was implemented through an agreement and plan of merger pursuant to Section 253 of the General Corporation Law of the State of Delaware (the “DGCL”) and did not require approval from either our or Centurion’s stockholders. The Certificate of Ownership merging Centurion into LadRx was filed with the Secretary of State of Delaware on March 9, 2022.

Effective September 26, 2022, we changed our name from CytRx Corporation to LadRx Corporation pursuant to a Certificate of Amendment to our Restated Certificate of Incorporation (the “Certificate of Incorporation”), as amended, filed with the Secretary of State of Delaware. In accordance with the DGCL, our board of directors (the “Board”) approved the name change and the Certificate of Amendment. Pursuant to Section 242(b)(1) of the DGCL, stockholder approval was not required for the name change or the Certificate of Amendment.

2023 Reverse Stock Split

The Company effected a 1-for-100 reverse stock split (the “Reverse Stock Split”) of its issued and outstanding shares of common stock on May 17, 2023, pursuant to which every 100 shares of the Company’s issued and outstanding shares of common stock were converted into one share of common stock without any change in the par value per share. Any fraction of a share of common stock that would otherwise have resulted from the Reverse Stock Split were rounded up to the nearest whole share. All share and per share amounts in this Annual Report have been adjusted to reflect the reverse stock split as if it had occurred at the beginning of the earliest period presented.

Corporate Information

We are a Delaware corporation, incorporated in 1985. Our corporate offices are located at 11726 San Vicente Boulevard, Suite 650, Los Angeles, California 90049, and our telephone number is (310) 826-5648. Our web site is located at http://www.cytrx.com.www.ladrxcorp.com. We do not incorporate by reference into this Annual Report the information on, or accessible through, our website, and you should not consider it as part of this Annual Report.

4

LADR Drug Discovery Platform

The LADR™ (Linker Activated Drug Release)Technology offers the opportunity for multiple pipeline drugs. The Company’s LADR™ technology platform consists of an organic backbone that is attached to a discovery engine combining our expertisechemotoxic agent. The purpose of the LADR™ backbone is to first target and deliver the chemotoxic agent to the tumor environment, and then to release the chemotoxic agent within the tumor. By delivering, concentrating, and releasing the chemotoxic agent within the tumor, one expects to reduce the off-target side-effects of the chemotherapeutic, which in linker chemistryturn allows for several-fold higher dosing of the chemotherapeutic to the patient. Being small organic molecules, the Company expects LADR-based drugs to offer the benefits of targeting the tumor without the complexity, side effects, and expense inherent in macromolecules such as antibodies and nanoparticles.

The Company’s LADR-based drugs use circulating albumin biologyas the binding target and as the trojan horse to create a pipeline of anti-cancer molecules that will avoid unacceptable systemic toxicity while delivering highly potent agents directlydeliver the LADR™ drugs to the tumor. We have createdAlbumin is the most abundant protein in plasma and accumulates inside tumors due to the aberrant vascular structure that exists within solid tumors. Tumors use albumin as a "toolbox"nutritional source and for transport of linker technologiessignaling and other molecules that haveare important to the ability to significantly increase the therapeutic index of ultra-high potency drugs (10-1,000 times more potent than traditional chemotherapies) by controlling the releasemaintenance and growth of the drug payloads and improving drug-like properties.


Our currenttumor, which makes albumin an excellent target for drugs that are intended for solid tumors.

The Company’s LADR™ development efforts are focused on two classes of ultra-high potency albumin-binding drug conjugates.drugs. These drug conjugatesLADR-based drugs, LADRs 7, 8, 9, and 10, combine ourthe proprietary LADR™ linkersbackbone with novel derivatives of the auristatin and maytansinoid drug classes. These payloads historically have required aAuristatin and maytansinoid are highly potent chemotoxins, and require targeting antibodyto the tumor for successfulsafe administration to humans.  Ourhumans, as is the case for the U.S. Food and Drug Administration (“FDA”)-approved drugs Adcetris (auristatin antibody-drug-conjugate manufactured by Seagen, Inc.) and Kadcyla (maytansine antibody-drug-conjugate manufactured by Genentech, Inc.). We believe that LADR-based drugs offer the benefits of tumor targeting without the disadvantages of antibodies and other macromolecules, which include expense, complexity, and negative side effects. Additionally, albumin is a very well-characterized drug conjugates eliminate the need for a targeting antibodytarget, which we believe will reduce clinical and provide a small molecule therapeutic option with potential broader applicability.


Ourregulatory costs and risks.

The Company’s postulated mechanism of action for the albumin-binding drug conjugatesLADR-based drugs is as follows:

after administration, the linker portion of the drug conjugate forms a rapid and specific covalent bond to the cysteine-34 position of circulating albumin;
circulating albumin preferentially accumulates at thein tumors bypassing concentration in other non-tumor sites, including the heart, liver and gastrointestinal tract due to a mechanism called "Enhanced Permeability“enhanced permeability and Retention";retention”, which results in lower exposure to the drug in noncancerous tissues of the heart, liver, and other organs;
once localized at the tumor, the acid-sensitive linker of the LADR™ backbone is cleaved due to the specific conditions within the tumor and in the tumor microenvironment; and
free active drug is then released.released within the tumor, causing tumor cell death.

Our strategy across these programs

The first-generation LADR-based drug is called Aldoxorubicin. Aldoxorubicin is the well-known drug doxorubicin attached to generate additional pre-clinical data that will allow themthe first generation LADR™ backbone (LADRs 7-10 employ a next generation LADR™ backbone). Aldoxorubicin has been administered to make informed decisions regarding the selection of one or both programs for moving intoover 600 human subjects in human clinical trials either independently orand has proven the concept of LADR™ in that several-fold more doxorubicin can be safely administered to patients when the doxorubicin is attached to LADR™ than when administered as native doxorubicin. Aldoxorubicin has been licensed to ImmunityBio and is currently in a Phase II trial for pancreatic cancer.

The next generation LADR™ drugs are termed LADR 7, 8, 9, and 10. A great deal of Investigational New Drug (“IND”) enabling work has already been accomplished on a partnered basis.LADR 7-10, including in-silico modeling, in-vitro efficacy testing in several different cancer models, in-vivo dosing, safety, and efficacy testing in several different cancer models in animals. We have also developed and proven manufacturability, an important step prior to beginning human clinical trials.

5

We recently entered into an agreement with Destum Partners, Inc., a leading strategic advisory firm serving companies

The IND-enabling work that remains prior to applying to the FDA for first-in-human studies for LADR 7-10 is limited due to the extensive experimentation already completed. For example, in the life sciences industry,case of LADR 7, a manufacturing run under Good Manufacturing Practices (GMP) has been completed and the GMP LADR 7 currently in hand is sufficient to assistcarry out final toxicology studies, and to initiate Phase IA studies in our pharma partnering activities. Destumhuman subjects.

The final toxicology studies required for the IND for LADR 7 are underway and we expect the toxicology studies to be completed and the IND application for LADR 7 to be filed with the FDA by the end of the third quarter of 2024 or the beginning of the fourth quarter of 2024. Absent a clinical hold from the FDA, this timeline should allow the Company to be ready for first-patient dosing with LADR 7 by the end of 2024 (the period for the FDA review of an IND application is 30 days). If the Company encounters difficulties with the toxicology program or fails to meet the FDA’s requirements for the IND application, the first-patient dosing could be substantially delayed.

Because the LADR™ backbone in future products would be the same as the LADR™ backbone in current product candidates, (i.e. the chemotoxin can be changed without changing the LADR™ backbone), management anticipates that future product candidates beyond LADR 7-10 may enjoy abbreviated pre-clinical pathways to first-in-human. Such abbreviated pathways would be subject to FDA review and agreement.

The Company’s novel companion diagnostic, ACDx™ (albumin companion diagnostic) was developed to identify patients with cancer who are most likely to benefit from treatment with the four LADR™ lead assets. We have not yet determined whether the use of a companion diagnostic will be our exclusive advisor fornecessary or helpful, and plan to continue to investigate this question in parallel to the identification of partnership opportunities for LADR™ ultra-high potency drug conjugates.

During 2017, our discovery laboratory synthesized and tested over 75 rationally designed drug conjugates with highly potent cytotoxic payloads, and two distinct classes of compounds have been created.  To date, four lead candidates have been selected based on in vitro and animal preclinical studies, stability, and manufacturing feasibility.  Additional animal efficacy and toxicology testing of these lead candidates is underway.
CytRx 2017 10-K Page #3#


Aldoxorubicin
Until July 2017, we were focused on the researchpre-clinical and clinical development of aldoxorubicin, our modified versionLADRs 7-10.

The LADR™ backbone and drugs that employ LADR™ are protected by domestic and international patents, and additional patents are pending.

Business Strategy for LADR™ Platform

With the non-dilutive financing concluded with XOMA (as defined below) in June 2023, the Company is now focused on completing the work necessary to file an IND application with the FDA for LADR7. For example, the Company recently completed the production of approximately 100 grams of LADR7 under GMP, which is sufficient to carry out final toxicology studies, and to initiate Phase IA studies in human subjects.

The Company has also initiated the Good Laboratory Practices (“GLP”) toxicology program that is expected to form the foundation of the widely-used chemotherapeutic agent, doxorubicin. Aldoxorubicin combinesIND application for LADR 7 to the chemotherapeutic agent doxorubicinFDA. Management expects the toxicology studies to be completed and the IND application for LADR 7 to be filed with the FDA by the end of the third quarter of 2024 or the beginning of the fourth quarter of 2024. Absent a clinical hold from the FDA, this timeline should allow the Company to be ready for first-patient dosing with LADR 7 by the end of 2024 (the period for the FDA review of an IND application is 30 days). If the Company encounters difficulties with the toxicology program or fails to meet the FDA’s requirements for the IND, the first-patient dosing could be substantially delayed.

Management will continue to explore in parallel both partnered and non-partnered funding and development strategies for LADR™ with a novel linker-molecule that binds specificallygoal of obtaining the least costly capital possible to albumin in the blood to allow for deliveryenable value inflection milestones.

6

Partnering of higher amounts of doxorubicin (3½ to 4 times) without several of the major dose-limiting toxicities seen with administration of doxorubicin alone.


Aldoxorubicin

On July 27, 2017, wethe Company entered into an exclusive worldwide license with ImmunityBio, Inc. (the “2017 License Agreement”) (formerly known as NantCell, Inc. ("NantCell", and which merged with NantKwest Inc. in March 2021 (“ImmunityBio”)), granting to NantCellImmunityBio the exclusive rights to develop, manufacture and commercialize aldoxorubicin in all indications, and our company isindications. As a result, we are no longer directly working on the development of aldoxorubicin. As part of the license, NantCell2017 License Agreement, ImmunityBio made a strategic investment of $13 million in CytRxLadRx’s common stock at $6.60$660.00 per share (adjusted to reflect our 2017 reverse stock split)splits), a premium of 92% to the market price on that date. WeThe Company also issued NantCell a warrant to ImmunityBio to purchase up to 500,0005,000 shares of common stock at $6.60 over$660.00 per share, which such warrant expired on January 26, 2019.

ImmunityBio is conducting an open-label, randomized, Phase 2 study of a combination of immunotherapy, aldoxorubicin, and standard-of-care chemotherapy versus standard-of-care chemotherapy alone for the following 18 months. We are entitledtreatment of locally advanced or metastatic pancreatic cancer in patients who have had 1 or 2 lines of treatment (Cohorts A and B) or 3 or greater lines of treatment (cohort C). In June 2022, Immunity Bio presented data at the American Society of Clinical Oncology meeting showing that patients receiving combination immunotherapy with aldoxorubicin plus standard-of-care chemotherapy experienced overall survival of 5.8 months, compared to receive up3 months for historical control patients that had received only the standard-of-care chemotherapy (n=78, 95% confidence interval of 4 to an aggregate of $343 million6.9 months). An additional 25 patients in potential milestone payments contingent upon achievement of certain regulatory approvals and commercial milestones. We are also entitled to receive ascending double-digit royalties for net sales for soft tissue sarcomas and mid to high single digit royalties for other indications.


Aldoxorubicin is a conjugatethe experimental group remain in the study. As of the commonly prescribed chemotherapeutic agent doxorubicin that binds to circulating albumin in the bloodstreamdate of this Annual Report, there have been no treatment-related deaths, and is believed to concentrate the drug at the site of the tumor. Aldoxorubicin, our lead clinical candidate, hasserious adverse events have been tested in over 600 patients with various types of cancer. Specifically, it is comprised of (6-maleimidocaproyl) hydrazine, an acid-sensitive molecule that is conjugated to doxorubicin.  The initial indication for aldoxorubicin is for patients with advanced soft tissue sarcomas (STS)uncommon (6%).

Aldoxorubicin has received Orphan Drug Designation (ODD)(“ODD”) by the U.S. FDA for the treatment of STS.soft tissue sarcoma (“STS”). ODD provides several benefits including seven years of market exclusivity after approval, certain R&D related tax credits, and protocol assistance by the FDA. European regulators granted aldoxorubicin Orphan designation for STS which confers ten years of market exclusivity among other benefits.


In

Royalty Purchase Agreement with XOMA

On June 21, 2023, the first quarter of 2018, we announced that NantCell was expanding aldoxorubicin's use by combining itCompany, entered into (i) a Royalty Purchase Agreement (the “Royalty Agreement”) with immunotherapiesXOMA (US) LLC (“XOMA”), for the sale, transfer, assignment and cell-based treatments, specifically in metastatic pancreatic cancer and in advanced squamous cell carcinomaconveyance of the headCompany’s right, title and neck or non-small cell lung cancer.


OUR CLINICAL DEVELOPMENT PROGRAMS
Our current clinical development programs are discussed below.
Aldoxorubicin
Aldoxorubicin is a conjugateinterest in and to certain royalty payments and milestone payments with respect to aldoxorubicin, and (ii) an Assignment and Assumption Agreement (the “Assignment Agreement”) with XOMA for the sale, transfer, assignment and conveyance of the commonly prescribed chemotherapeutic agent doxorubicin that binds to circulating albuminCompany’s right, title and interest in the bloodstreamAsset Purchase Agreement (the “2011 Arimoclomol Agreement”) between the Company and is believedOrphazyme ApS (“Orphazyme”), dated as of May 13, 2011, and assigned to concentrateZevra Denmark A/S (“Zevra Denmark”), effective as of June 1, 2022, which includes certain royalty and milestone payments with respect to arimoclomol. The combined aggregate purchase price paid to the drug atCompany for the sitesale, transfer, assignment and conveyance of tumors.  Specifically, itthe Company’s right, title and interest in and to aldoxorubicin and arimoclomol was $5 million, less certain transaction fees and expenses.

The Royalty Agreement and the Assignment Agreement also provide for up to an additional $6 million based on regulatory and commercial milestones related to the development of arimoclomol and aldoxorubicin by their respective sponsors, Zevra, Inc. and Immunity Bio. The $6 million in potential post-closing payments is comprised of (6-maleimidocaproyl) hydrazine, an acid-sensitive molecule that is conjugated to doxorubicin. Aldoxorubicin was out-licensed to NantCell in July 2017.

Aldoxorubicin for$1 million upon acceptance by the Treatment of Cancer. Anthracyclines are a class of drugs that are among the most commonly used agents in the treatment of cancer. Doxorubicin, the first anthracycline to gain FDA approval, has demonstrated efficacy in a wide variety of cancers, including breast cancer, lung cancer, ovarian cancer, sarcomas, and lymphomas. However, due to the uptake of doxorubicin by various parts of the body, it is associated with side effects such as cumulative cardiotoxicity, myelosuppression (decreased production of blood cells by bone marrow), gastrointestinal disorders, mucositis (inflammation of the mucous membranes lining the mouth and digestive tract), stomatitis (inflammation of soft tissue of the mouth), and necrotizing extravasation (damage due to the leakage of intravenous drugs from the vein into the surrounding tissue).
We believe aldoxorubicin has attributes that may improve on doxorubicin, alone, which we sometimes refer to as native doxorubicin, including the potential to increase the total doxorubicin dose, reduce certain adverse events associated with native doxorubicin, achieve increased drug concentration at tumor sites and improve efficacy.
Pre-clinical data. In a variety of preclinical models, aldoxorubicin was superior to doxorubicin at equitoxic doses in its ability to allow an increase in the total doxorubicin dose, its antitumor efficacy and its safety, including a reduction in cardiotoxicity. Animal studies conducted by aldoxorubicin inventor Dr. Felix Kratz demonstrated statistically significant efficacy compared to both placebo and native doxorubicin against breast, ovarian, pancreatic and small cell lung cancer models growing in immunodeficient mice.
Clinical data. In July 2016, we announced the initial analysis of top-line data from our on-going global, randomized Phase 3 clinical trial of aldoxorubicin as a treatment for patients with relapsed or refractory soft tissue sarcomas, or STS. The trial enrolled 433 patients.  Aldoxorubicin performed better than investigator's choice for the entire study population, and narrowly missed statistical significance in progression-free survival, or PFS (p=0.12; HR=0.81, 95% CI 0.64-1.06), the trial's primary endpoint.  All responses were determined by an independent, blinded central radiology lab assessment of scans.
CytRx 2017 10-K Page #4#

On November 29, 2016, we announced updated results from the Phase 3 clinical trial, which demonstrated a statistically significant improvement in PFS between aldoxorubicin and investigator's choice therapy in 246 patients with either leiomyosarcoma or liposarcoma, (p=0.007).  The hazard ratio (HR) was 0.62 (95% CI 0.44-0.88), representing a 38% reduction in the risk of tumor progression for patients receiving aldoxorubicin versus investigator's choice.  Leiomyosarcoma and liposarcoma, the two most common types of STS, accounted for 57% of the patients enrolled in the overall trial.  Aldoxorubicin also demonstrated a statistically significant improvement in PFS over investigator's choice in 312 patients treated in North America plus Australia (p=0.028; HR=0.71, 95% CI 0.53-0.97).
Aldoxorubicin did not cause clinically significant cardiac, renal, or hepatic toxicities.  For the global trial population, the most commonly reported adverse events were neutropenia and anemia consistent with prior clinical trials with aldoxorubicin. Grade 3 or higher adverse events were manageable with supportive care and occurred at a rate of 61% for patients receiving aldoxorubicin and 46% in patients treated with investigator's choice.  Treatment-emergent adverse events leading to discontinuation occurred in 4.2% of patients treated with aldoxorubicin, compared to 6.3% for patients receiving investigator's choice.  Serious adverse events, primarily febrile neutropenia that resolved and rarely led to treatment termination occurred more frequently in patients administered aldoxorubicin.  Three treatment-related deaths occurred in aldoxorubicin-treated patients, while there were no treatment-related deaths among patients receiving investigators' choice of drugs.
Based upon the updated results of the Phase 3 trial, we met with the FDA in the first quarter of 2017. Following the meeting with the FDA, we announced that we planned to pursue a 505(b)(2) regulatory pathway for aarimoclomol New Drug Application (NDA) filing.
We completed our global Phase 2b clinical trial(“NDA”), $1 million upon first commercial sale of arimoclomol, and $4 million upon FDA approval of aldoxorubicin. All royalty and milestone payments made to evaluateXOMA will be net of the preliminary efficacyexisting licensing and safetymilestone obligations owed by LadRx related to arimoclomol and aldoxorubicin.

Pursuant to the Royalty Agreement, the Company agreed to sell, transfer, assign and convey to XOMA, among other payments, all royalty payments and regulatory and commercial milestone payments payable to the Company pursuant to the worldwide license agreement, dated July 27, 2017, by and between the Company and Immunity Bio. The Royalty Agreement also provides for the sharing of aldoxorubicincertain rights with XOMA to bring any action, demand, proceeding or claim as related to receiving such payments.

Management determined that the Royalty Agreement is not considered to be with a first-line therapy in patients with advanced STS who are ineligiblecustomer, and it does not fall within the scope of ASC 606. Instead, the Royalty Agreement represents an in-substance sale of nonfinancial assets, and, therefore, should be accounted for surgery. The 123-subject Phase 2b clinical trial providedwithin the first direct clinical trial comparisonscope of aldoxorubicin and native doxorubicinASC 610-20. As such, the Company recognized such net proceeds as a first-line therapy for STS. The primary endpoint was PFS as determined by a blinded radiology review performed at an independent central radiology laboratory. The results from this trial were publishedother income in the Journalaccompanying statement of operations.

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Transfer of Rights to Molecular Chaperone Assets (Orphayzme)

On May 13, 2011, pursuant to the American Medical Association (JAMA) Oncology in September 2015 (JAMA Oncology 2015 Sep 17:1-9.).

In the Phase 2b clinical trial, aldoxorubicin was found to be relatively safeAsset Purchase Agreement by and well-tolerated. Subjects treated with aldoxorubicin had an approximately two-fold increase in severe neutropenia compared with doxorubicin-treated subjects, but there was no difference in the incidence of febrile neutropenia (indicating an infection may be present) between the two groups. All adverse events in subjects treated with aldoxorubicin were consistent with the known side effects of doxorubicin, usually resolved before the administration of the next doseCompany and did not require treatment discontinuation. There were no treatment-related deaths in the aldoxorubicin group.
A Phase 1 study of aldoxorubicin that demonstrated safety and objective clinical responses in several tumor types was completed in 2005 and published in Clinical Cancer Research in August 2007.  Of 35 evaluable patients, 23 had either an objective clinical (partial) response or stable disease.
We completed a Phase 1b/2 clinical trial with aldoxorubicin in patients with advanced solid tumors who had either relapsed or failed to respond to their prior chemotherapy. Clinical benefit was shown in ten of 13 (76.9%) evaluable patients with relapsed or refractory STS. There were no observed cardiac toxicities and no drug-related patient deaths. The results of this clinical trial were published in February 2015 in the peer-reviewed journal Cancer (Cancer, 2015 Feb 15; 121(4); 570-9).
Our Phase 1b clinical trial evaluating pharmacokinetics demonstrated that aldoxorubicin has a distribution half-life of approximately 20 to 24 hours, with a narrow volume of distribution to healthy tissue and slow clearance from the circulation. Complete details from this trial were published in the journal Investigational New Drugs (Invest New Drugs, 2015 Apr 15; (33(2):341-8).
In September 2016, we completed enrollment in our global Phase 2b clinical trial evaluating aldoxorubicin compared to topotecan in subjects with extensive-stage small cell lung cancer (SCLC) who have relapsed or were refractory to prior chemotherapy. The open-label Phase 2b clinical trial enroll approximately 135 patients (1:1 randomization).  The primary endpoint is PFS and the secondary endpoints are OS, overall response rates (partial and complete) and the safety of aldoxorubicin compared to topotecan in this population.  This trial was ongoing when aldoxorubicin was out-licensed to NantCell, Inc.
 We completed a Phase 2 clinical trial evaluating the preliminary efficacy and safety of aldoxorubicin in patients with unresectable glioblastoma whose tumors have progressed following prior treatment with surgery, radiation and with the drug temozolomide. The clinical trial has enrolled its target of 28 patients and demonstrated that an albumin-binding therapy can enter the brain and have anti-tumor activity. At the 2016 American Society for Clinical Oncology (ASCO) Annual Meeting, the trial results were presented including the median overall survival of 8.6 months.
We completed a Phase 2 clinical trial evaluating the preliminary efficacy of aldoxorubicin in patients with AIDS-related Kaposi's sarcoma. Results presented at the 2016 ASCO Annual Meeting showed that aldoxorubicin localized in the tumor lesions and compared to non-tumor tissues.  Eleven of 13 patients (85%) treated with low dose aldoxorubicin achieved a partial response at week four.
We also conducted a Phase 1b/2 trial in combination with ifosfamide in patients with STS, and completed a Phase 1b trial in combination with gemcitabine in subjects with metastatic solid tumors. Since most chemotherapy agents are administered in combination with other chemotherapeutics, these studies will demonstrate the dose of aldoxorubicin that can be administered with two other chemotherapies that are commonly used to treated patients with sarcomas, pancreatic cancer, ovarian cancer and lung cancer.
CytRx 2017 10-K Page #5#

Disposition of Molecular Chaperone Assets
Until 2011, we ownedOrphazyme A/S (“Orphazyme”, formerly Orphazyme ApS), LadRx sold the rights to two drug candidates, arimoclomol and iroxanadine, based on molecular chaperone regulation technology, that were designed to repair or degrade mis-folded proteins associated with disease. On May 13, 2011, we sold all pre-clinical and clinical data, intellectual property rights and other assets relating to those compounds to Orphazyme ApS in exchange for a cashone-time, upfront payment of $150,000 and the right to receive various futureup to a total of $120 million in milestone payments that are contingent upon the achievement of specifiedcertain pre-specified regulatory and business milestones, as well as royalty payments based on a specified percentage of any eventual net sales of products derived from arimoclomol (the “2011 Arimoclomol Agreement”). Orphazyme transferred its rights and obligations under the assets. 
Innovive Acquisition2011 Arimoclomol Agreement
On September 19, 2008, we completed our merger acquisition to KemPharm Denmark A/S (“KemPharm”), a wholly owned subsidiary of Innovive Pharmaceuticals,KemPharm Inc., in May 2022.

In May 2021, Orphazyme announced that the pivotal phase 3 clinical trial for arimoclomol in Amyotrophic Lateral Sclerosis did not meet its primary and secondary endpoints, reducing the maximum amount that LadRx currently has the right to receive under the 2011 Arimoclomol Agreement to approximately $100 million. Orphazyme also tested arimoclomol in Niemann-Pick disease Type C (“NPC”) and Gaucher disease, and following a Phase II/III trial submitted to the FDA a NDA for the treatment of NPC with arimoclomol. On June 18, 2021, Orphazyme announced it had received a complete response letter (the “Complete Response Letter”) from the FDA indicating the need for additional data. In late October 2021, Orphazyme announced it held a Type A meeting with the FDA, at which the FDA recommended that Orphazyme submit additional data, information and analyses to address certain topics in the Complete Response Letter and engage in further interactions with the FDA to identify a pathway to resubmission. The FDA concurred with Orphazyme’s proposal to remove the cognition domain from the NPC Clinical Severity Scale (“NPCCSS”) endpoint, with the result that the primary endpoint is permitted to be recalculated using the 4- domain NPCCSS, subject to the submission of additional requested information which Orphazyme had publicly indicated that it intended to provide. To bolster the confirmatory evidence already submitted, the FDA affirmed that it would require additional in vivo or Innovive,pharmacodynamic (PD)/pharmacokinetic (PK) data.

Orphazyme had also submitted a Marketing Authorization Application (“MAA”) with the European Medicines Agency (the “EMA”). In February 2022, Orphazyme announced that although they had received positive feedback from the Committee for Medicinal Products for Human Use (“CHMP”) of the EMA, they were notified by the CHMP of a negative trend vote on the MAA for arimoclomol for NPC following an oral explanation.

On May 31, 2022, Orphazyme announced that it had completed the sale of substantially all of its assets and its clinical-stage cancer product candidates,business activities for cash consideration of $12.8 million and assumption of liabilities estimated to equal approximately $5.2 million to KemPharm (the “KemPharm Transaction”). KemPharm is a specialty biopharmaceutical company focused on the discovery and development of novel treatments for rare CNS diseases. As part of the KemPharm Transaction, all of Orphazyme’s obligations to LadRx under the 2011 Arimoclomol Agreement, including aldoxorubicinwith regard to milestone payments and tamibarotene. Underroyalties on sales, were assumed by KemPharm. KemPharm is expected to continue the merger agreement byearly access programs with arimoclomol, and to continue to pursue the potential approval of arimoclomol as a treatment option for NPC. KemPharm resubmitted the NDA for arimoclomol in 2023. It is also identifying a regulatory path forward with the EMA. KemPharm re-branded to Zevra Therapeutics, Inc. in February 2023.

Assignment and Assumption Agreement with XOMA

On June 21, 2023, the Company entered into the Assignment Agreement with XOMA, pursuant to which, we acquired Innovive, weamong others, the Company agreed to paysell, transfer and assign to XOMA the former Innovive stockholders upCompany’s right, title and interest in the arimoclomol pursuant to approximately $18.3the 2011 Arimoclomol Agreement, including the right to receive certain milestone, royalty and other payments from Zevra.

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Pursuant to the Assignment Agreement, the Company is entitled to receive (i) a one-time payment of $1 million upon acceptance of future earnout merger consideration,a re-submission of a NDA to the FDA for arimoclomol, and (ii) a one-time payment of $1 million upon the first invoiced sale in certain territories of a pharmaceutical product derived from arimoclomol as an active pharmaceutical ingredient, subject to our achievementthe receipt of specified net sales under the Innovive license agreements. The earnout merger consideration, if any, will be payableapplicable regulatory approval required to sell such a product in sharessuch countries. In January 2024, Zevra announced the FDA had accepted the NDA for arimoclomol and the Company received the one-time payment of our common stock, subject to specified conditions, or, at our election,$1 million in cash or by a combination of shares of our common stock and cash. Our common stock will be valued for purposes of any future earnout merger consideration based upon the trading price of our common stock at the time the earnout merger consideration is paid. The earnout will be accrued if and when earned.

Research and Development
Expenditures for research and development activities related to continuing operations were $19.8 million, $35.9 million and $43.4 million for the years ended December 31, 2017, 2016 and 2015, respectively, or approximately 60%, 68% and 68%, respectively, of our total expenses. For further information regarding our research and development activities, see "Management's Discussion and Analysis of Financial Condition and Results of Operations" below.

Manufacturing
We do not have the facilities or expertise to manufacture clinical supplies of aldoxorubicin or any of our other product candidates, and we lack the resources and capability to manufacture any of our product candidates on a commercial scale. Accordingly, we are dependent upon third-party manufactures, or potential future strategic alliance partners, to manufacture these supplies. Currently, we are no longer responsible for manufacturing aldoxorubicin, having entered into an exclusive licensing agreement with NantCell, Inc.
February 2024.

Commercialization and Marketing

We currently have no sales, marketing or commercial product distribution capabilities or experience in marketing products.

As additional product

We are searching for a development and commercialization partner or a financing for our LADR drug candidates advance through our pipeline, ourand do not currently plan on commercializing them ourselves. Over the past two years, we have been unable to attract either a development and commercial plans may change. In particular, some of our pipeline assets target potentially large solid tumor indications.  Factors such as clinical data, the size of the development programs, the size of the target market, the size ofpartner or a commercial infrastructure, and manufacturing needs may influence our strategies in the U.S., the European Union, and other territories.

CytRx 2017 10-K Page #6#

financing for this endeavor; however, we are continuing to pursue all possibilities.

Patents and Proprietary Technology

We actively seek patent protection for our technologies, processes, uses, and ongoing improvements and consider our patents and other intellectual property to be critical to our business. We regularly evaluate the patentability of new inventions and improvements developed by us or our collaborators, and, whenever appropriate, will endeavor to file U.S. and international patent applications to protect these new inventions and improvements. We cannot be certain that any of the current pending patent applications we have filed or licensed, or any new patent applications we may file or license, will ever be issued in the U.S. or any other country. There also is no assurance that any issued patents will be effective to prevent others from using our products or processes. It is also possible that any patents issued to us, as well as those we have licensed or may license in the future, may be held invalid or unenforceable by a court, or third parties could obtain patents that we would need to either license or to design around, which we may be unable to do. Current and future competitors may have licensed or filed patent applications or received patents and may acquire additional patents and proprietary rights relating to compounds, products or processes that may be competitive with ours.

In addition to patent protection, we attempt to protect our proprietary products, processes and other information by relying on trade secrets and non-disclosure agreements with our employees, consultants and certain other persons who have access to such products, processes and information. Under the agreements, all inventions conceived by employees are our exclusive property, but there is no assurance that these agreements will afford significant protection against misappropriation or unauthorized disclosure of our trade secrets and confidential information.

As of DecemberJanuary 31, 2017,2024, we have three granted U.S. patents and fifty granted foreign patents, and two pending U.S. patent applications and thirteentwenty-four pending foreign patent applications covering our LADRTM-related technology including LADR 7, LADR-8, LADR-9 and DK049.LADR-10. The unextendedun-extended patent term of patents that issue covering our LADRTM-related technology is between June 2036 and November 2038. We also have one granted foreign patent, one pending US patent application, and thirteen pending foreign patent applications covering our albumin companion diagnostic (ACDxTM). The un-extended patent term of patents that issue covering our ACDxTM is July 2039. The patents and patent applications covering our LADRTM-related technology, and DK049 is June 2038.ACDxTM are assigned to LadRx. In conjunction with our July 27,the 2017 NantCell licensing agreement,License Agreement, we granted NantCellImmunityBio an exclusive license to all our aldoxorubicin-related patents, including the rights in fourthree granted U.S. patents, 72twenty-one granted foreign patents two pending U.S. patent applications, and fourteensix pending foreign patent applications covering aldoxorubicin and related technologies. Our intellectual property holdings relating to aldoxorubicin, and related technologies include an exclusive license from Vergell Medical, S.A. or Vergell, to U.S. and foreign patents and patent applications.Vergell. Patents and applications that cover pharmaceutical compositions ofcomprising aldoxorubicin processes for their production, and their use in treatment methods (e.g.,treating cancer (including glioblastoma), viral diseases, autoimmune diseases, and acute or chronic inflammatory diseases) have unextendedun-extended patent terms expiring between June 2020December 2033 and June 2034.


LICENSE AGREEMENTS
Aldoxorubicin
We are the licensee of patent rights held by KTB for the worldwide development and commercialization of aldoxorubicin under a license agreement dated April 17, 2006. In February 2017, we received notice that KTB had transferred and assigned its rights and obligations under the license to Vergell Medical, S.A. The license is exclusive and applies to all products that may be subject to the licensed intellectual property in all fields of use. We may sublicense the intellectual property in our sole discretion. Pursuant to an amendment to the license agreement entered into in March 2014, we also have a non-exclusive worldwide license to any additional technology that is claimed or disclosed in the licensed patents and patent applications for use in the field of oncology.
Under the agreement, we must make payments to Vergell in the aggregate of up to $7.5 million upon meeting clinical and regulatory milestones, and up to and including the product's second final marketing approval. We also agreed to pay:

commercially reasonable royalties based on a percentage of net sales (as defined in the agreement);9
a percentage of any non-royalty sub-licensing income (as defined in the agreement); and
milestones of $1 million for each additional final marketing approval that we obtain.
In the event that we must pay a third party in order

LICENSE AGREEMENTS

Molecular Chaperone Assets

The agreement relating to exercise our worldwide rights to the intellectual property under the agreement, we are entitled to deduct a percentage of those payments from the royalties due Vergell,arimoclomol provides for our payment up to an agreedaggregate of $3.65 million upon cap.

Under the agreement with Vergell, we must use commercially reasonable efforts to conduct the research and development activities we determine are necessary to obtain regulatory approval to market aldoxorubicin in those countries that we determine are commercially feasible. Under the agreement, Vergell is to use its commercially reasonable efforts to provide us with access to suppliersreceipt of the active pharmaceutical ingredient, or API, of aldoxorubicin, on the same terms and conditions as may be provided to Vergell by those suppliers.
The agreement will expire on a product-by-product basis upon the expiration of the subject patent rights. We have the right to terminate the agreement on 30 days' notice, provided we pay a cash penalty to Vergell. Vergell may terminate the agreement if we are in breach and the breach is not cured within a specified cure period, or if we fail to use diligent and commercial efforts to meet specified clinical milestones.
CytRx 2017 10-K Page #7#

milestone payments from Zevra ( formerly KemPharm).

Competition

The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. While we believe that our LADR™ technology platform and ultra-high potency albumin-bind drug conjugates provide us with competitive advantages, we face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions and governmental agencies and public and private research institutions. Any drug candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future.

Many competitors and potential competitors have substantially greater scientific, research and product development capabilities, as well as greater financial, marketing and human resources than we do. In addition, many specialized biotechnology firms have formed collaborations with large, established companies to support the research, development and commercialization of products that may be competitive with ours.

There are many companies developing antibody-drug conjugates (ADC) for the treatment of cancer and some that use the same classes of cytotoxic payloads as we are currently using. These include Takeda Pharmaceutical Co. Ltd. and Seattle Genetics Inc. who market Adcetris®, and F. Hoffmann-LaRoche Ltd./Genentech who market Kadcyla®. According to www.clinicaltrials.gov, theremany other major pharmaceutical companies, including Celgene Corp. and GlaxoSmithKline are approximately 75 clinical trials testing an ADC that arein either on-going or currently enrolling.enrolling clinical trials. Other companies have created or have programs to create potent cell‑killingcell-killing agents for attachment to antibodies or other targeting agents. These companies may compete with us for technology out‑licenseout-license arrangements.

In addition to ADCs, we face competition from other nanomedicine platforms developing targeted therapies, including platforms focused on nanoparticles and liposomes. Non‑ADCNon-ADC therapies may be in development for the cancer types we or our partners elect to pursue. Further, these companies may also compete with us for technology out‑licenseout-license arrangements.

Continuing development of conventional and targeted chemotherapeuticscytotoxins by large pharmaceutical companies and biotechnology companies may result in new compounds that may compete with our product candidates. More recently, immuno-oncology therapies that stimulate the body'sbody’s own defense system to attack cancers are being developed by certain of these companies and some have been approved for use as cancer therapeutics. In the future, immuno-oncology agents including cell therapies, targeted therapies or cytotoxic treatments may compete with our product candidates. Other companies have created or have programs to create potent cell‑killingcell-killing agents for attachment to tumor targeting agents. These companies may compete with us for technology out‑licenseout-license arrangements.

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we obtain approval for ours. In addition, our ability to compete may be affected in many cases by insurers or other third-party payors seeking to encourage the use of generic products. If our drug candidates achieve marketing approval, we expect that they will be priced at a significant premium over competitive generic products.

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Many companies, including large pharmaceutical and biotechnology firms with financial resources, research and development staffs, and facilities that may be substantially greater than those of ours or our strategic partners or licensees, are engaged in the research and development of pharmaceutical products that could compete with our potential products. To the extent that we seek to acquire, through license or otherwise, existing or potential new products, we will be competing with numerous other companies, many of which will have substantially greater financial resources, large acquisition and research and development staffs that may give those companies a competitive advantage over us in identifying and evaluating these drug acquisition opportunities. Any products that we acquire will be competing with products marketed by companies that in many cases will have substantially greater marketing resources than we have. The industry is characterized by rapid technological advances and competitors may develop their products more rapidly and such products may be more effective than those currently under development or that may be developed in the future by our strategic partners or licensees. Competitive products for a number of the disease indications that we have targeted are currently being marketed by other parties, and additional competitive products are under development and may also include products currently under development that we are not aware of or products that may be developed in the future.

CytRx 2017 10-K Page #8#

Government Regulation

Regulation of Pharmaceuticals in the United States

The U.S. and other developed countries extensively regulate the preclinical and clinical testing, manufacturing, labeling, storage, record-keeping, advertising, promotion, export, marketing and distribution of drugs and biologic products. TheIn the United States, the FDA, under the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Public Health Service (“PHS”) Act and other federal statutes and regulations, regulates pharmaceutical and biologic products.

products and product candidates, and the parties engaged in the development, testing, manufacture, distribution, storage, marketing, labeling, advertising, and/or commercialization thereof (in addition to any other related activities) are subject to rigorous pre- and post-market requirements.

To obtain FDA approval of our product candidates from the FDA,for a new drug candidate, we must, among other requirements, submit data supporting the candidate’s safety and efficacy for the intended indicationindication(s), as well as detailed information on the manufacture and composition of the product candidate. In most cases, this will require extensive laboratory tests and preclinical and clinical trials. The collection of these data, as well as the preparation of applications for review by the FDA involve significant time and expense.expense and are inherently complex and uncertain. The FDA may not act quickly or favorably in reviewing these applications, and we (and/or any current or future partners in development) may encounter significant difficulties or costs in our (and/or their) efforts to obtain FDA approvals that could delay or preclude the U.S. commercialization of one or more of our product candidates.

The process required by the FDA before a new drug may be marketed in the U.S. generally involves some or all of the following key steps:

completion of nonclinical studies, such as laboratory tests, animal studies, and formulation studies, performed in compliance with FDA regulations for good laboratory practices (“GLPs”) and other applicable regulations;
design of a clinical protocol and its submission to the FDA as part of an Investigational New Drug application (“IND”), which must become effective before human clinical trials may begin;
performance of adequate and well-controlled human clinical trials according to good clinical practices (“GCPs”) to establish the safety and efficacy of the product candidate for its intended use;
submission of an NDA to the FDA along with payment of the application user fee and FDA acceptance of that NDA as a complete submission eligible for substantive review;
satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities at which the active pharmaceutical ingredient, or API, and finished drug product are produced and tested to assess readiness for commercial manufacturing and conformance to the manufacturing-related elements of the application, to conduct a data integrity audit, and to assess compliance with current good manufacturing practices (“cGMPs”), in order to assure that the facilities, methods and controls are adequate to preserve the drug candidate’s identity, strength, quality and purity;
possible inspection of selected clinical study sites to confirm compliance with GCP requirements and data integrity; and

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FDA substantive review and approval of the NDA, including satisfactory completion of an FDA advisory committee review of the product candidate, if applicable, which must occur prior to any commercial marketing or sale of the drug product in the United States.

Preclinical Studies

After a therapeutic candidate is identified for development, it enters the preclinical or nonclinical testing stage. Preclinical studies include laboratory evaluation of product chemistry, toxicity and formulation, as well as animal studies to assess potential safety and efficacy. Preclinical tests intended for submission to the FDA to support the safety of a product candidate must be conducted in compliance with GLP regulations and the United States Department of Agriculture’s Animal Welfare Act, if applicable. A drug sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data and any available clinical data or literature, among other things, to the FDA as part of an IND. Some nonclinical testing may continue after the IND is submitted. In addition to including the results of the nonclinical studies, the IND will include one or more clinical protocols detailing, among other things, the objectives of the clinical trial and the safety and effectiveness criteria to be evaluated.

An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions related to one or more proposed clinical trials and places the clinical trial on a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not result in the FDA allowing clinical trials to commence. A clinical hold may occur at any time during the life of an IND and may affect one or more specific studies or all studies conducted under the IND. Occasionally, clinical holds are imposed due to manufacturing issues that may present safety issues for the clinical study subjects.

Human Clinical Trials in Support of an NDA

The clinical investigation of an investigational new drug is divided into three phases that typically are conducted sequentially but may overlap or be combined. The three phases are as follows:

Phase 1. Phase 1 includes initial clinical trials introducing an investigational new drug into humans and may be conducted in subjects with the target disease or healthy volunteers. These trials are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.
Phase 2. Phase 2 includes the controlled clinical trials conducted to evaluate the effectiveness of the drug candidate for a particular indication or indications in subjects with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase 2 trials are typically well controlled, closely monitored, and conducted in a relatively small number of subjects.
Phase 3. Phase 3 trials are typically large trials performed after preliminary evidence suggesting effectiveness of the drug candidate has been obtained. They are intended to gather additional information about the effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling and product marketing approval. Phase 3 trials usually are conducted at geographically dispersed clinical study sites.

A clinical trial may combine the elements of more than one phase and the FDA often requires more than one Phase 3 trial to support marketing approval of a product candidate. A company’s designation of a clinical trial as being of a particular phase is not necessarily indicative that the study will be sufficient to satisfy the FDA requirements of that phase because this determination cannot be made until the protocol and data have been submitted to and reviewed by the FDA. Human clinical trials are inherently uncertain and Phase 1, Phase 2 and Phase 3 testing may not be successfully completed.

A pivotal trial is a clinical trial that is believed to satisfy FDA requirements for the evaluation of a product candidate’s safety and efficacy such that it can be used, alone or with other pivotal or non-pivotal trials, to support regulatory approval. Generally, pivotal trials are Phase 3 trials, but they may be Phase 2 trials if the design provides a well-controlled and reliable assessment of clinical benefit, particularly in an area of unmet medical need.

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Clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with the FDA’s GCP requirements. They must be conducted under protocols detailing the objectives of the trial, dosing procedures, research subject selection and exclusion criteria and the safety and effectiveness criteria to be evaluated. Each protocol, and any subsequent material amendment to the protocol, must be submitted to the FDA as part of the IND, and progress reports detailing the status of the clinical trials must be submitted to the FDA annually. Sponsors also must report to the FDA serious and unexpected adverse reactions in a timely manner, any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigation brochure or any findings from other studies or animal or in vitro testing that suggest a significant risk in humans exposed to the product or therapeutic candidate. The FDA may order the temporary or permanent discontinuation of a clinical trial at any time, via a clinical hold, or impose other sanctions if it believes that the clinical trial is not being conducted in accordance with FDA requirements or that the subjects are being exposed to an unacceptable health risk. An institutional review board (“IRB”), is responsible for ensuring that human subjects in clinical studies are protected from inappropriate study risks. An IRB at each institution participating in the clinical trial must review and approve the protocol before a clinical trial commences at that institution and must also approve the information regarding the trial and the consent form that must be provided to each research subject or the subject’s legal representative, monitor the trial until completed and otherwise comply with IRB regulations. The IRB also may require post-marketinghalt a study, either temporarily or permanently, for failure to comply with GCP or the IRB’s requirements, or if the investigational new drug has been associated with unexpected serious harm to patients.

During the development of a new drug product candidate, sponsors are given opportunities to meet with the FDA at certain points; specifically, prior to the submission of an IND, at the end of Phase 2 and before an NDA is submitted. Meetings at other times may be requested. These meetings can provide an opportunity for the sponsor to share information about the data gathered to date and for the FDA to provide advice on the next phase of development. Sponsors typically use the meeting at the end of Phase 2 to discuss their Phase 2 clinical results and present their plans for the pivotal Phase 3 clinical trial that they believe will support the approval of the new therapeutic.

Post-approval trials, sometimes referred to as “Phase 4” clinical trials, may be conducted after initial marketing approval. These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication. In certain instances, FDA may mandate the performance of “Phase 4” clinical trials.

Concurrent with clinical trials, sponsors usually complete additional animal safety studies, develop additional information about the chemistry and physical characteristics of the product candidate and finalize a process for manufacturing commercial quantities of the product candidate in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other criteria, the sponsor must develop methods for testing the identity, strength, quality, and purity of the finished drug product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to monitordemonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

Marketing Application Submission and FDA Review

Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, detailed information on the product candidate is submitted to the FDA in the form of an NDA requesting approval to market the drug for one or more indications. An NDA includes all relevant data available from pertinent nonclinical studies and clinical trials, including negative or ambiguous results as well as positive findings, together with detailed information on the product candidate’s chemistry, manufacturing, and controls, or CMC, and proposed labeling, among other things. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and efficacy of approved products or place conditions on any approvals that could restrict the therapeutic claims and commercial applications of these products. Regulatory authorities may withdraw product approvals if we fail to comply with regulatory standards or if we encounter problems at any time following initial marketing of our products.

The first stage of the FDA approval process for a new drug involves completion of preclinical studies and the submission of the results of these studies to the FDA. These data, together with proposed clinical protocols, manufacturing information, analytical data and other information submitted to the FDA, in an investigational new drug application, or IND, must become effective before human clinical trials may commence. Preclinical studies generally involve FDA regulated laboratory evaluation of product characteristics and animal studies to assess the efficacy and safety of the product candidate.

After the IND becomes effective, a company may commence human clinical trials. These are typically conducted in three sequential phases, but the phases may overlap. Phase 1 trials consist of testing of the product candidate for its intended use to the satisfaction of the FDA.

Under the Prescription Drug User Fee Act (“PDUFA”), each NDA must be accompanied by a significant user fee. The FDA adjusts the PDUFA user fees on an annual basis. PDUFA also imposes an annual program fee for prescription drug products. Fee waivers or reductions are available in certain circumstances, such as where a waiver is necessary to protect the public health, where the fee would present a significant barrier to innovation, or where the applicant is a small number of patients or healthy volunteers, primarilybusiness submitting its first human therapeutic application for safety at one or more doses. Phase 2 trials, in additionreview.

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Under the goals and policies agreed to safety, evaluate the efficacy of the product candidate in a patient population somewhat larger than Phase 1 trials. Phase 3 trials typically involve additional testing for safety and clinical efficacy in an expanded population at multiple test sites. A company must submit toby the FDA under PDUFA, the FDA has ten months from receipt in which to complete its initial review of a clinical protocol, accompaniedstandard NDA for a drug that is not a new molecular entity, and six months from the receipt date for an application with priority review. The FDA does not always meet its PDUFA goal dates, and the review process is often significantly extended by FDA requests for additional information or clarification and a sponsor’s process to respond to such inquiries. As a result, the approval of the Institutional Review Boards at the institutions participating in the trial, prior to commencement of each clinical trial.

ToNDA review process can be very lengthy. Most innovative drug products (other than biological products) obtain FDA marketing authorization, a company must submitapproval pursuant to the FDA the resultsan NDA submitted under Section 505(b)(1) of the preclinical and clinical testing, together with, among other things, detailed information on the manufacture and composition of the product candidate, in the form ofFDCA, commonly referred to as a new drug application, ortraditional (or full) NDA.
The amount of time taken by the FDA for approval of an NDA will depend upon a number of factors, including whether the product candidate has received priority review, the quality of the submission and studies presented, the potential contribution that the compound will make in improving the treatment of the disease in question, and the workload at the FDA.

The FDA may, in some cases, confer upon an investigational product the status of a fast-track product. A fast-track product is defined as a new drug or biologic intended for the treatment of a serious or life-threatening condition that demonstrates the potential to address unmet medical needs for this condition. The FDA can base approval of an NDA for a fast-track product on an effect on a surrogate endpoint, or on another endpoint that is reasonably likely to predict clinical benefit. Ifconducts a preliminary review of clinical data suggestsall NDAs it receives to ensure that a fast-trackthey are sufficiently complete for substantive review before it accepts them for filing. The FDA may refuse to file any NDA that it deems incomplete or not properly reviewable at the time of submission, and may request additional information rather than accept an NDA for filing. In this event, the application must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing. The FDA has 60 days after submission of an NDA to conduct an initial review to determine whether it is sufficient to accept for filing. If the submission is accepted for filing, the FDA begins an in-depth substantive review of the NDA. The FDA reviews the NDA to determine, among other things, whether the proposed product may beis safe and effective for its intended use, whether it has an acceptable purity profile and whether the product is being manufactured in accordance with cGMPs. During its review of an NDA, the FDA may initiate reviewrefer the application to an advisory committee of entire sections of a marketing applicationindependent experts for a fast-track product beforerecommendation as to whether the application should be approved. An advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendation of an advisory committee, but it typically follows such recommendations. Data from clinical trials are not always conclusive, and the FDA or its advisory committee may interpret data differently than the NDA sponsor completesinterprets the application.

We anticipate that our products will be manufactured by our strategic partners, licensees or other third parties. same data. The FDA may also re-analyze the clinical trial data, which could result in extensive discussions between the FDA and the applicant during the review process.

Before approving an NDA, the FDA will typically inspect the facilities at which the product is manufactured andmanufactured. The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the FDA'sproduct within required specifications. Additionally, before approving the NDA, the FDA will typically inspect one or more clinical sites to assure that the clinical trials were conducted in compliance with IND trial requirements and GCP requirements and to assure the integrity of the clinical data submitted to the FDA. To ensure cGMP and GCP compliance by its employees and third-party contractors, an applicant must incur significant expenditure of time, money and effort in the areas of training, record keeping, production and quality control.

The FDA may also require the submission of a risk evaluation and mitigation strategy, or “REMS,” if it determines that a REMS is necessary to ensure that the benefits of the drug outweigh its risks and to assure the safe use of the product. A REMS could include medication guides, physician communication plans, assessment plans and/or elements to assure safe use, such as restricted distribution methods, patient registries or other risk minimization tools. The FDA determines the requirement for a REMS, as well as the specific REMS provisions, on a case-by-case basis. If the FDA concludes a REMS is needed, the sponsor must include a proposed REMS within its NDA submission.

After evaluating the NDA and all related information, including the advisory committee recommendation, if any, and inspection reports regarding the manufacturing facilities where the drug product or its API will be produced and the clinical trial sites, the FDA will either issue an approval letter or, in some cases, a complete response letter (“CRL”) that describes all of the specific deficiencies that the FDA has identified in the NDA. A CRL indicates that the review cycle of the application is complete but that the application will not be approved in its present form. The deficiencies identified may be minor (e.g., requiring labeling changes) or major (e.g., requiring additional clinical trials and/or other time-consuming and expensive measures to generate the requisite safety and/or efficacy data). After receiving a CRL, an applicant may either resubmit the NDA, addressing all of the deficiencies identified in the letter or withdraw the application. FDA will issue a letter within 30 days of an NDA resubmission acknowledging receipt and informing the applicant as follows. For resubmissions deemed to be complete responses to all deficiencies identified in the CRL, such letter will contain FDA’s designation of the resubmission as Class 1 or Class 2 (based on the nature of information received therein) and the corresponding due date by which it will take action (2 months for Class 1 resubmissions and 6 months for Class 2). If FDA does not find the resubmission to be a complete response to all CRL deficiencies, the FDA will inform the applicant, and the FDA’s “review clock” will not start until a complete response is received.

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Even if a drug product receives NDA approval, the approval may be significantly limited to specific indications and dosages and/or subject to limitations, specific labeling requirements, and/or other conditions that must be met to lawfully market the product in the United States, any or all of which could restrict the commercial value of the product. For example, the FDA may require that certain contraindications, warnings, and/or precautions be included in the product’s labeling. The FDA may also impose restrictions and conditions on product distribution, prescribing, or dispensing in the form of a REMS, or otherwise limit the scope of any approval. In addition, the FDA may require post marketing clinical trials, sometimes referred to as “Phase 4” clinical trials, designed to further assess a product’s safety and effectiveness, and/or testing and surveillance programs to monitor the safety of approved products that have been commercialized.

Post-Approval Requirements for Prescription Drugs

Following approval of a new drug product, the manufacturer and the approved drug are subject to pervasive and continuing regulation by the FDA, including, among other things, monitoring and recordkeeping activities, reporting of adverse experiences with the product, product sampling and distribution restrictions, and promotion and advertising requirements.

Promotional communications must be carefully crafted to ensure compliance with all applicable FDA regulations pertaining to prescription-drug marketing and labeling. In particular, prescription-drug advertisements must generally (1) not be false or misleading, (2) present a “fair balance” of information describing both the risks and benefits associated with the drug, (3) include facts that governare “material” to the manufacture,product’s advertised uses, and (4) include a “brief summary” that mentions every risk described in the product’s labeling. Further, where the intended use of a prescription drug differs from the intended use approved by FDA, as listed in the product’s approved NDA, FDA has asserted that the product is an unapproved “new drug” and taken enforcement action against sponsors for introducing such unapproved new drugs into interstate commerce in violation of the FDCA. This prohibited practice is also called “off-label” promotion. Although physicians may prescribe legally available products for off-label uses, sponsors may not legally market or promote such uses. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

To market an approved drug product for a new indication (i.e., beyond and/or differing from that set forth in the approved NDA), the sponsor must submit a new NDA (or NDA supplement), which, in many cases, will require the completion of adequate and well-controlled clinical trials to demonstrate the product’s safety and efficacy in the new indication. There is no guarantee that FDA will approve an NDA seeking an expansion of an approved drug’s labeling and/or indications for use more quickly than an NDA involving a novel product (i.e., that has never been approved for any indication) or ever. Relatedly, if the sponsor (or a contractor, partner, or other affiliated party) makes any post-market modifications to an approved drug or the production thereof, including changes in labeling or manufacturing processes or facilities, among other things, it may be required to submit and obtain FDA approval of a new NDA or an NDA supplement.

In addition, FDA regulations require that products be manufactured in specific approved facilities and in accordance with cGMPs. The cGMP regulations include requirements relating to organization of personnel, buildings and facilities, equipment, control of components and drug product containers and closures, production and process controls, packaging and labeling controls, holding and distribution, laboratory controls, records and reports and returned or salvaged products. Drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and some state agencies, and are subject to periodic unannounced inspections by the FDA for compliance with cGMPs and other requirements. Changes to the manufacturing process, specifications or container closure system for an approved drug product are strictly regulated and often require prior FDA approval before being implemented. FDA regulations also require, among other things, the investigation and correction of any deviations from cGMPs and the imposition of reporting and documentation requirements upon the NDA sponsor and any third-party manufacturers involved in producing the approved drug product. Accordingly, both sponsors and manufacturers must continue to expend time, money, and effort on systems relating to production and quality control to maintain cGMP compliance and other aspects of quality control and quality assurance, and to ensure ongoing compliance with other statutory requirements of the FDCA. We anticipate that the products we may commercialize in the United States (if any) will be manufactured by our strategic partners (including licensees) or contractors (including any third parties who may be engaged by us or one of our partners to conduct any commercialization activities, as well as downstream subcontractors, as applicable) and we may, thus, be subject to enforcement action for any such third parties’ failures to comply with the applicable post-market regulations or otherwise be adversely affected by any of our partners’ or contractors’ compliance issues.

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The FDA may withdraw its approval for a product. Ourdrug product if compliance with regulatory requirements is not maintained or unexpected problems occur after the product reaches the market. Later discovery of previously unknown problems with a drug, including serious and/or unexpected adverse experiences, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies to assess new safety risks; or the imposition of distribution or other restrictions under a REMS.

We and/or our present or future suppliers, contract manufacturers, and/or other affiliates involved in one or more of our current or future U.S. development and/or commercialization activities (if applicable) may not be able to comply with all FDA regulatory requirements. For example, we may believe that all clinical studies are being conducted in accordance with the FDA’s IND regulations and that none of our investigational products are being promoted with claims of safety and/or effectiveness for the intended use(s) for which they are under investigation, but the FDA may determine otherwise, which could subject us to enforcement action and/or delay or prevent the ultimate approval of our applicable product candidate(s). From a post-market perspective, with regard to any products we may commercialize in the United States in the future, we may believe our manufacturing operations (including that of our partners and/or contractors, as applicable) are fully compliant with cGMPs and that all promotional communications disseminated by or on behalf of us are consistent with FDA’s prescription-drug marketing requirements, but the FDA may disagree and take enforcement action against us. Accordingly, we could be subject to a number of adverse enforcement actions and/or penalties in connection with any failure(s) to comply with the FDCA and/or its implementing regulations at any stage in development and/or commercialization (if applicable), including, but not limited to, the following:

fines, warning letters, untitled letters, public warnings, consumer advisories, “dear doctor” letters, and other similar publications or issuances;
refusal of the FDA to approve pending NDAs or supplements to approved NDAs;
seizure, detention, import alerts;
injunctions or the imposition of civil or criminal penalties;
consent decrees, corporate integrity agreements, debarment, or exclusion from federal healthcare programs; or
mandated modification of promotional materials and labeling and the issuance of corrective information.

We and our manufacturers and other partners in development and/or (future) commercialization, as applicable, also will be subject to regulation under the Occupational Safety and Health Act, the National Environmental Policy Act, the Nuclear Energy and Radiation Control Act, the Toxic Substance Control Act and the Resource Conservation and Recovery Act. Following approval, the FDA periodically inspects drug and biologic manufacturing facilities to ensure continued compliance with the good manufacturing practices regulations. Our manufacturersWe will have to continue to comply with those requirements. Failure to comply with these requirements subjects the manufacturer to possible legal or regulatory action, such as suspension of manufacturing or recall or seizure of product. Adverse patient experiences with the product must be reported to the FDA and could result in the imposition of marketing restrictions through labeling changes or market removal. Product approvals may be withdrawn if compliance with regulatory requirements is not maintained or if problems concerning safety or efficacy of the product occur following approval.

The labeling, advertising, promotion, marketing and distribution of a drug or biologic product also must be in compliance with FDA and Federal Trade Commission requirements which include, among others, standards and regulations for off-label promotion, industry sponsored scientific and educational activities, promotional activities involving the internet, and direct-to-consumer advertising. We also will be subject to a variety of federal, state and local regulations relating to the use, handling, storage and disposal of hazardous materials, including chemicals and radioactive and biological materials. In addition, we will be subject to various laws and regulations governing laboratory practices and the experimental use of animals. In each of these areas, as above, the FDA has broad regulatory and enforcement powers, including the ability to levy fines and civil penalties, suspend or delay issuance of product approvals, seize or recall products, and deny or withdraw approvals.

We will also be subject to a variety of regulations governing clinical trials and sales of our products outside the U.S. Whether or not FDA approval has been obtained, approval of a product candidate by the comparable regulatory authorities of foreign countries and regions must be obtained prior to the commencement of marketing the product in those countries. The approval process varies from one regulatory authority to another and the time may be longer or shorter than that required for FDA approval. In the European Union, Canada and Australia, regulatory requirements and approval processes are similar, in principle, to those in the U.SU.S.

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Other U.S. Healthcare Laws and Regulations

Healthcare Reform Measures

On March 23, 2010, former President Obama signed the “Patient Protection and Affordable Care Act” (P.L. 111-148) (the “ACA”) and on March 30, 2010, he signed the “Health Care and Education Reconciliation Act” (P.L. 111-152), collectively commonly referred to as the “Healthcare Reform Law.” The Healthcare Reform Law included a number of new rules regarding health insurance, the provision of healthcare, conditions to reimbursement for healthcare services provided to Medicare and Medicaid patients, and other healthcare policy reforms. Through the law-making process, substantial changes have been and continue to be made to the current system for paying for healthcare in the U.S., including changes made to extend medical benefits to certain Americans who lacked insurance coverage and to contain or reduce healthcare costs (such as by reducing or conditioning reimbursement amounts for healthcare services and drugs, and imposing additional taxes, fees, and rebate obligations on pharmaceutical and medical device companies). This legislation was one of the most comprehensive and significant reforms ever experienced by the U.S. in the healthcare industry and has significantly changed the way healthcare is financed by both governmental and private insurers. This legislation has impacted the scope of healthcare insurance and incentives for consumers and insurance companies, among others. Additionally, the Healthcare Reform Law’s provisions were designed to encourage providers to find cost savings in their clinical operations. Pharmaceuticals represent a significant portion of the cost of providing care. This environment has caused changes in the purchasing habits of consumers and providers and resulted in specific attention to the pricing negotiation, product selection and utilization review surrounding pharmaceuticals. This attention may result in our current commercial products, products we may commercialize or promote in the future, and our therapeutic candidates, being chosen less frequently or the pricing being substantially lowered. At this stage, it is difficult to estimate the full extent of the direct or indirect impact of the Healthcare Reform Law on us.

These structural changes could entail further modifications to the existing system of private payors and government programs (such as Medicare, Medicaid, and the State Children’s Health Insurance Program), creation of government-sponsored healthcare insurance sources, or some combination of both, as well as other changes. Restructuring the coverage of medical care in the U.S. could impact the reimbursement for prescribed drugs and pharmaceuticals, including our current commercial products, those we and our development or commercialization partners are currently developing or those that we may commercialize or promote in the future. If reimbursement for the products we currently commercialize or promote, any product we may commercialize or promote, or approved therapeutic candidates is substantially reduced or otherwise adversely affected in the future, or rebate obligations associated with them are substantially increased, it could have a material adverse effect on our reputation, business, financial condition or results of operations.

Extending medical benefits to those who currently lack coverage will likely result in substantial costs to the U.S. federal government, which may force significant additional changes to the healthcare system in the U.S. Much of the funding for expanded healthcare coverage may be sought through cost savings. While some of these savings may come from realizing greater efficiencies in delivering care, improving the effectiveness of preventive care and enhancing the overall quality of care, much of the cost savings may come from reducing the cost of care and increased enforcement activities. Cost of care could be reduced further by decreasing the level of reimbursement for medical services or products (including our current commercial products, our development or commercialization partners or any product we may commercialize or promote, or those therapeutic candidates currently being developed by us), or by restricting coverage (and, thereby, utilization) of medical services or products. In either case, a reduction in the utilization of, or reimbursement for our current commercial products, any product we may commercialize or promote, or any therapeutic candidate, or for which we receive marketing approval in the future, could have a material adverse effect on our reputation, business, financial condition or results of operations.

Several states and private entities initially mounted legal challenges to the Healthcare Reform Law, in particular, the ACA, and they continue to litigate various aspects of the legislation. On July 26, 2012, the U.S. Supreme Court generally upheld the provisions of the ACA at issue as constitutional. However, the U.S. Supreme Court held that the legislation improperly required the states to expand their Medicaid programs to cover more individuals. As a result, states have a choice as to whether they will expand the number of individuals covered by their respective state Medicaid programs. Some states have not expanded their Medicaid programs and have chosen to develop other cost-saving and coverage measures to provide care to currently uninsured individuals. Many of these efforts to date have included the institution of Medicaid-managed care programs. The manner in which these cost-saving and coverage measures are implemented could have a material adverse effect on our reputation, business, financial condition or results of operations, particularly once we and/or any of our partners have products on the U.S. market, if ever.

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CytRx

Further, the healthcare regulatory environment has seen significant changes in recent years and is still in flux. Legislative initiatives to modify, limit, replace, or repeal the ACA and judicial challenges have continued. We cannot predict the extent to which our business may be impacted by legal challenges to the ACA or other aspects of the Healthcare Reform Law or other changes to the current laws and regulations. The financial impact of U.S. healthcare reform legislation over the next few years will depend on a number of factors, including the policies reflected in implementing regulations and guidance and changes in sales volumes for therapeutics affected by the legislation. From time to time, legislation is drafted, introduced and passed in the U.S. Congress that could significantly change the statutory provisions governing coverage, reimbursement, and marketing of pharmaceutical products. In addition, third-party payor coverage and reimbursement policies are often revised or interpreted in ways that may significantly affect our business and any products we or our partners may commercialize in the future, as well as the prospects and/or viability of our product candidates.

During his time in office, former President Trump supported the repeal of all or portions of the ACA. President Trump also issued an executive order in which he stated that it is his administration’s policy to seek the prompt repeal of the ACA and in which he directed executive departments and federal agencies to waive, defer, grant exemptions from, or delay the implementation of the provisions of the ACA to the maximum extent permitted by law. Congress has enacted legislation that repeals certain portions of the ACA, including but not limited to the Tax Cuts and Jobs Act, passed in December 2017, 10-K Page #9#which included a provision that eliminates the penalty under the ACA’s individual mandate, effective January 1, 2019, as well as the Bipartisan Budget Act of 2018, passed in February 2018, which, among other things, repealed the Independent Payment Advisory Board (which was established by the ACA and was intended to reduce the rate of growth in Medicare spending).

Additionally, in December 2018, a district court in Texas held that the individual mandate is unconstitutional and that the rest of the ACA is, therefore, invalid. On appeal, the Fifth Circuit Court of Appeals affirmed the holding on the individual mandate but remanded the case back to the lower court to reassess whether and how such holding affects the validity of the rest of the ACA. The Fifth Circuit’s decision on the individual mandate was appealed to the U.S. Supreme Court. On June 17, 2021, the Supreme Court held that the plaintiffs (comprised of the state of Texas, as well as numerous other states and certain individuals) did not have standing to challenge the constitutionality of the ACA’s individual mandate and, accordingly, vacated the Fifth Circuit’s decision and instructed the district court to dismiss the case. As a result, the ACA will remain in-effect in its current form for the foreseeable future; however, we cannot predict what additional challenges may arise in the future, the outcome thereof, or the impact any such actions may have on our business.

The Biden administration also introduced various measures in 2021 focusing on healthcare and drug pricing, in particular. For example, on January 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through the ACA marketplace, which began on February 15, 2021, and remained open through August 15, 2021. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. On the legislative front, the American Rescue Plan Act of 2021 was signed into law on March 11, 2021, which, in relevant part, eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source drugs and innovator multiple source drugs, beginning January 1, 2024. And, in July 2021, the Biden administration released an executive order entitled, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription drugs. In response, on September 9, 2021, HHS released a “Comprehensive Plan for Addressing High Drug Prices” that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles. And, in November 2021, President Biden announced the “Prescription Drug Pricing Plan” as part of the Build Back Better Act (H.R. 5376) passed by the House of Representatives on November 19, 2021, which aims to lower prescription drug pricing by, among other things, allowing Medicare to negotiate prices for certain high-cost prescription drugs covered under Medicare Part D and Part B after the drugs have been on the market for a certain number of years and imposing tax penalties on drug manufacturers that refuse to negotiate pricing with Medicare or increase drug prices “faster than inflation.” If enacted, this bill could have a substantial impact on our business. In the coming years, additional legislative and regulatory changes could be made to governmental health programs that could significantly impact pharmaceutical companies and the success of our product candidates. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

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There is uncertainty as to what healthcare programs and regulations may be implemented or changed at the federal and/or state level in the U.S. or the effect of any future legislation or regulation. Furthermore, we cannot predict what actions the Biden administration will implement in connection with the Health Reform Law. However, it is possible that such initiatives could have an adverse effect on our or our partners’ ability to obtain approval for and/or successfully commercialize products in the U.S. in the future.

Fraud and Abuse, Transparency, and Privacy

In the United States, we may be subject to various federal and state laws and regulations regarding fraud and abuse in the healthcare industry, as well as industry standards and guidance, such as the codes issued by the Pharmaceutical Research and Manufacturers of America (or “PhRMA Codes”), which some states reference or incorporate in their statutes and regulations. These laws, regulations, standards, and guidance may impact, among other things, our sales and marketing activities and our relationships with healthcare providers and patients. In addition, we may be subject to patient privacy regulations by both the federal government and the states in which we conduct our business. The laws that may affect our ability to operate include but are not limited to:

the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order, or recommendation of, an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs;
federal civil and criminal false claims laws and civil monetary penalty laws, including the False Claim Act, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from the federal government, including Medicare, Medicaid, or other third-party payors, that are false or fraudulent;

The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which imposes federal criminal and civil liability for executing, or attempting to execute, a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters;

the federal transparency laws, including the Physician Payments Sunshine Act, which requires applicable manufacturers of covered drugs to disclose payments and other transfers of value provided to physicians and teaching hospitals and physician ownership and investment interests;
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and its implementing regulations, also imposes certain requirements relating to the privacy, security, and transmission of individually identifiable health information; and
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines, state laws that require pharmaceutical manufacturers to report certain pricing or payment information, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and are not preempted by HIPAA, thus complicating compliance efforts.

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Because of the breadth of these laws and the narrow scope of the statutory or regulatory exceptions and safe harbors available, our current or future activities, policies, and/or arrangements could be challenged under one or more of these laws. In addition, the federal government has identified relationships between drug companies (and other medical-product manufacturers) and healthcare providers as particularly susceptible to fraud and abuse and, thus, our relationships may be subject to heightened regulatory scrutiny, particularly once we have one or more products on the U.S. market, if ever. Further, many of the applicable healthcare laws and regulations are subject to varying and/or evolving interpretations, which makes achieving and maintaining consistent compliance more difficult. We may have to devote substantial costs, resources, and time to compliance efforts, particularly once one or more of our product candidates, or any other products to which we may obtain commercialization rights in the future, is marketed in the United States. If any of our past, current, or future operations and/or arrangements are found to be in violation of If our operations are found to be in violation of any healthcare laws or regulations that may apply to us, we may be subject to significant civil, criminal, and/or administrative penalties; damages; fines; personal imprisonment; exclusion from government-funded programs, such as Medicare and Medicaid; additional reporting requirements and oversight under a corporate integrity (or deferred prosecution or other similar) agreement with the applicable federal or state agency or agencies (such as the U.S. Office of Inspector General (“OIG”), the U.S. Department of Justice (“DOJ”), or state attorneys general); and/or the curtailment or restructuring of our operations. Any adverse enforcement action initiated against us based on actual or alleged violations of one or more of the healthcare laws and regulations could have a material adverse effect on our business, even if we are ultimately successful in defending against such claims.

Employees

As of March 16, 2018,December 31, 2023, we had twenty employees, thirteen of whom were engaged in preclinical research at our Freiburg, Germany laboratory, and seven of whom were involved in management and administrative operations.

two full-time employees.

Available Information

We maintain a website at www.cytrx.comwww.ladrxcorp.com and make available there, free of charge, our periodic reports filed with the Securities and Exchange Commission or SEC,(the “SEC”), as soon as is reasonably practicable after filing. The public may readAmong other things, we post on our website our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and copy any materials we file with the SEC at the SEC's Public Reference Room at 100 F Street, NE, Washington, DC 20549. The public may obtain information on the operationamendments and Code of the Public Reference Room by calling the SEC at 1-800-SEC-0330.Business Conduct and Ethics. The SEC maintains a website at http://www.sec.gov that contains reports, proxy and information statements, and other information regarding issuers such as us that file electronically with the SEC. Among other things, we post on

Item 1A. RISK FACTORS

We are subject to various risks that may materially harm our website our Code of Business Conduct and Ethics.

Potential Strategic Alternatives
From time to time, we may consider strategic alternatives available to us to enhance shareholder value. Strategic alternatives could include the acquisition of or strategic partnership with one or more parties or the licensing of some of our proprietary technologies. See "Item 1A – Risk Factors – The impactbusiness, prospects, financial condition and results of operations. An investment in our explorationcommon stock is speculative and involves a high degree of strategic alternatives are uncertainrisk. In evaluating an investment in our common stock, you should carefully consider the risks described below, together with the other information included in this Form 10-K, including the consolidated financial statements and may not be successful."
Item 1A. RISK FACTORS
related notes thereto.

You should carefully consider the risks and uncertainties facing our business. The risks described below are not the only ones facing us.risks we face. If any of the events described in the following risk factors actually occurs, or if additional risks and uncertainties later materialize, that are not presently known to us or that we currently deem immaterial, then our business, prospects, results of operations and financial condition could be materially adversely affected. In that event, the trading price of our common stock could decline, and you may lose all or part of your investment in our shares. The risks discussed below include forward-looking statements, and our actual results may differ substantially from those discussed in these forward-looking statements. Our business is also subject to the risks that affect many other companies, such as employment relations, general economic conditions and geopolitical events. Further, additional risks not currently known to us or that we currently believe are immaterial may in the future materially and adversely affect our business, operations, liquidity and stock price.

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Risk Factor Summary

Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below following this Risk Factor summary and should be carefully considered, together with other information in this Form 10-K and our other filings with the SEC, before making an investment decision regarding our common stock.

Risks Associated With Our Business:

We have operated at a loss and will likely continue to operate at a loss for the foreseeable future.

Our independent registered public accounting firm has included an explanatory paragraph in its report as of and for the year ended December 31, 2023 expressing substantial doubt in our ability to continue as a going concern based on our recurring and continuing losses from operations and our need for additional funding to continue operations.

Because we have no source of significant recurring revenue, we must depend on capital raising to sustain our operations, and our ability to raise capital may be severely limited.
If Zevra fails to successfully develop and commercialize arimoclomol, our business prospects will be materially adversely affected.
If ImmunityBio fails to successfully develop aldoxorubicin or our exclusive licensing arrangement with ImmunityBio is otherwise unsuccessful, our business prospects will be materially adversely affected.

Risks Associated With Drug Discovery and Development:

If the projected development goals for our product candidates are not achieved in the expected time frames, the commercialization of our products may be delayed and our business prospects may suffer. Our financial projections also may prove to be materially inaccurate.
The regulatory approval process is lengthy, time consuming and inherently unpredictable, and if our products or those we have sold or licensed are not successfully developed and approved by the FDA or foreign regulatory authorities, we may be forced to reduce or curtail our operations.
Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
We may be unable to protect our intellectual property rights, which could adversely affect our ability to compete effectively.
If our product candidates infringe the rights of others, we could be subject to expensive litigation or be required to obtain licenses from others to develop or market them.
The results of pre-clinical studies or early clinical trials are not necessarily predictive of future results, and our ultra-high potency albumin-binding drug conjugates may not have favorable results in later clinical trials or receive regulatory approval.
Any products that we develop or are sold or licensed may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which could have a material adverse effect on our business.
Healthcare legislative reform measures could hinder or prevent the commercial success of our products and product candidates.
We may also be subject to healthcare laws, regulation and enforcement and our failure to comply with those laws could adversely affect our business, operations and financial condition.
We will be required to pay substantial milestone and other payments relating to the commercialization of our products.
The COVID-19 endemic and its ongoing effects could adversely impact our business and prospects, including active and planned clinical trials by ImmunityBio and Zevra.
In the event of a dispute regarding our international drug development, it may be necessary for us to resolve the dispute in the foreign country of dispute, where we would be faced with unfamiliar laws and procedures.
Drug discovery is a complex, time-consuming and expensive process, and we may not succeed in creating new product candidates.
We have a limited operating history in drug discovery, which is inherently risky, and we may not succeed in addressing these risks.

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General Risk Factors:

We are subject to intense competition, and we may not compete successfully.
We are subject to potential liabilities from clinical testing and future product liability claims.
We may be unable to successfully acquire additional technologies or products. If we require additional technologies or products, our product development plans may change and the ownership interests of our shareholders could be diluted.
The impact and results of our exploration of any strategic alternatives are uncertain and may not be successful.
We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity incidents, could harm our ability to operate our business effectively.
Our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
You may experience future dilution as a result of future equity offerings or other equity issuances.
Our outstanding options and warrants and the availability for resale of the underlying shares may adversely affect the trading price of our common stock.
We cannot assure investors that our internal controls will prevent future material weaknesses.
We could be subject to legal actions that could adversely affect our financial condition.
Our anti-takeover measures may make it more difficult to change our management, or may discourage others from acquiring us, and thereby adversely affect stockholder value.
Our By-laws designate the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.
We may issue preferred stock in the future, and the terms of the preferred stock may reduce the value of our common stock.
We do not expect to pay any cash dividends on our common stock.

Risks Associated With Our Business

We have operated at a loss and will likely continue to operate at a loss for the foreseeable future.

We have operated at a loss due to our ongoing expenditures for research and development of our product candidates and for general and administrative purposes, and lack of significant recurring revenues. WeFor the year ended December 31, 2023, we realized a net income of $0.4 million, had a loss from operations of $3.8 million , incurred a net loss of $35.0$4.2 million for the year ended December 31, 2017 and $50.8 million for the year ended December 31, 20162022, and had an accumulated deficittotal stockholders’ equity as of December 31, 20172023 of $450.9$0.1 million. We have had no recurring revenue, and we are likely to continue to incur losses unless and until we are able to commercialize aldoxorubicinconclude a successful strategic partnership or one or more offinancing for our other existing or possible future product candidates.LADR™ technology. These losses, among other things, have had and will continue to have an adverse effect on our stockholders'stockholders’ equity and working capital. Because of the numerous risks and uncertainties associated with our product development efforts, we are unable to predict when we may become profitable, if at all. If we do not become profitable or are unable to maintain future profitability, the market value of our common stock will be adversely affected. These factors individually and collectively raise a substantial doubt about our ability to continue as a going concern.

Our independent registered public accounting firm has included an explanatory paragraph in its report as of and for the year ended December 31, 2023 expressing substantial doubt in our ability to continue as a going concern based on our recurring and continuing losses from operations and our need for additional funding to continue operations. Our consolidated financial statements do not include any adjustments that might result from the outcome of this going concern uncertainty and have been prepared under the assumption that we will continue to operate as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. If we are unable to continue as a going concern, we may be forced to liquidate our assets which would have an adverse impact on our business and developmental activities. In such a scenario, the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements. The reaction of investors to the inclusion of a going concern statement by our independent registered public accounting firm and our potential inability to continue as a going concern may materially adversely affect our stock price and our ability to raise new capital or to enter into strategic alliances.

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Because we have no source of significant recurring revenue, we must depend on capital raising to sustain our operations, and our ability to raise capital may be severely limited.

Developing products and conducting clinical trials require substantial amounts of capital. To date,We need to raise additional capital to fund our general and administrative expenses and, if we have relied primarily upon proceeds from sales ofdetermine to develop products based on our equity securities under our "shelf" registration statements on Form S-3 filed with the SEC and proceeds from the exercise of options and warrants to generate funds needed to finance our business and operations. WeLADR™ technology platform, we will need to raise additional capital to amongfund development of product candidates, prepare, file, prosecute, maintain, enforce and defend patent and other things:

fund development of product candidates based on our LADR™ technology;
finance our general and administrative expenses
acquire or license new technologies;
prepare, file, prosecute, maintain, enforce and defend our patent and other proprietary rights; and
develop and implement sales, marketing and distribution capabilities to successfully commercialize any product for which we obtain marketing approval and choose to market ourselves.
CytRx 2017 10-K Page #10#

The depressed market price of our common stock may severely limit our ability to continue to raiseproprietary rights, and develop and implement sales, marketing and distribution capabilities. However, capital because the aggregate or market value of our common stock held by non-affiliates, referred to as our "public float," as of the file date of this Annual Report is less than $75 million.  As a result, under Instruction I.B.6 to Form S-3 the aggregate amount of securities that we can offer and sell under our "shelf" registration statements in any 12-month period cannot exceed one-third of our public float, or approximately $20.5 million as of March 16, 2018.  If our public float increases to $75 million or more, we will no longer be subject to this limitation.
raising has been significantly challenging.

At December 31, 2017,2023, we had cash and cash equivalents of approximately $37.6$2.1 million. Under the termsThe continuation of the loan agreement, however,Company as a going concern is dependent upon its ability to obtain necessary debt or equity financing to continue operations until it begins generating positive cash flow. No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to us. Even if we are required to maintain cash equal to a minimum of the greater of three months projected cash burn or $10 million. Management believes that our current resources will be sufficient to fund our operations for the foreseeable future. This estimate is based, in part, upon our currently projected expenditures for 2018 and the first three months of 2019 of approximately $27.8 million (unaudited), which includes approximately $1.5 million (unaudited) for our  clinical programs, approximately $3.1 million (unaudited) for pre-clinical development of new high potency cytotoxic albumin-binding cancer drugs, approximately $0.7 million (unaudited) for general operation of its clinical programs, approximately $10.1 million (unaudited) for other general and administrative expenses and $12.4 million of interest and principal payments on our outstanding term loan. These projected expenditures are also based upon numerous other assumptions and subject to many uncertainties, and actual expenditures may be significantly different from these projections. While these projections represent our current expected expenditures, we have the ability to reduce the amounts and alter the timing of research and development expenditures as needed to manage its liquidity needs while still advancing its research and development objectives. We will ultimately be requiredable to obtain additional funding in order to execute our long-term business plans, although we do not currently have commitments from any third parties to provide us with long term debt or capital. We cannot assure that additional funding will be available on favorable terms, or at all. If we fail to obtain additional funding when needed, wefinancing, it may not be able to execute our business plans and our business may suffer, which would have a material adverse effectcontain undue restrictions on our financial position, resultsoperations, in the case of operations and cash flows.

If we are not successfuldebt financing or cause substantial dilution for our stockholders, in negotiating an agreement with a strategic partner to advance at least one lead compound from our Freiburg operations, we may reduce our headcount and discontinue certain development programs and drug discovery activities. For these reasons and others, our operating results may fluctuate from period to period, and the resultscase of prior periods should not be relied upon as predictive of the results in future periods. Furthermore, if we obtain marketing approval and successfully commercialize aldoxorubicin, or another product candidate, we anticipate it will take a minimum of two years, and likely longer, for us to generate significant recurring revenue, and we will be dependent on future financing until such time, if ever, as we can generate significant recurring revenue. We have no commitments from third parties to provide us with any additional financing, and we may not be able to obtain future financing on favorable terms, or at all. Failure to obtain adequate financing would adversely affect our ability to operate as a going concern. equity financing.

If we raise additional funds by issuing equity securities, dilution to stockholders may result and new investors could have rights superior to holders of the shares issued in this offering.current equity holders. In addition, debt financing, if available, may include restrictive covenants. If adequate funds are not available to us, we may have to liquidate some or all of our assets or to delay or reduce the scope of or eliminate some portion or all of our development programs or clinical trials.programs. We also may have to license to other companies our product candidates or technologies that we would prefer to develop and commercialize ourselves.

If NantCell failseither Zevra or ImmunityBio fail to successfully develop and commercialize arimoclomol and aldoxorubicin, or our exclusive licensing arrangement with NantCell is otherwise unsuccessful,respectively, our business prospects will be materially adversely affected.

In July 2017,June 2023, we entered into the Royalty Agreement with XOMA, for the sale, transfer, assignment and conveyance of our right, title and interest in and to certain royalty payments and milestone payments with respect to aldoxorubicin, and the Assignment Agreement with XOMA for the sale, transfer, assignment and conveyance of our right, title and interest in the 2011 Arimoclomol Agreement between us and Orphazyme and assigned to Zevra Denmark, effective as of June 1, 2022, which includes certain royalty and milestone payments with respect to arimoclomol. Under this Royalty Agreement, we are entitled to (i) a one-time payment of $1 million upon acceptance of a re-submission of a NDA to the FDA for arimoclomol, and a one-time payment of $1 million upon first invoiced sale in certain territories of a pharmaceutical product derived from arimoclomol as an exclusive licensing agreementactive pharmaceutical ingredient, subject to the receipt of the applicable regulatory approval required to sell such a product in such countries. In January 2024, Zevra announced the FDA had accepted the NDA for arimoclomol, and we received the one-time payment of $1 million in February 2024.

Pursuant to the Royalty Agreement, we also agreed to sell, transfer, assign and convey to XOMA, among other payments, all royalty payments and regulatory and commercial milestone payments payable to us pursuant to the 2017 License Agreement. The Royalty Agreement also provides for the sharing of certain rights with NantCellXOMA to complete the clinical development ofbring any action, demand, proceeding or claim as related to receiving such payments and commercialization$4 million upon FDA approval of aldoxorubicin. Under this agreement, NantCell has committed to provide substantial funding, as well as significant capabilities in clinical development, regulatory affairs, marketing and sales.

If, for any reason, NantCell does not devote sufficient time and resources to the development and commercialization of aldoxorubicin, we will not realize the potential commercial benefits of the arrangement, and our results of operations will be adversely affected. In addition, if NantCell were to breach or terminate its arrangement with us, the development and commercialization of aldoxorubicin could be delayed, curtailed or terminated, and we may not have sufficient financial resources or capabilities to continue development and commercialization of aldoxorubicin on our own.
Under our agreement with NantCell, they may opt out of a project by giving us twelve months' prior written notice. If NantCell were to exercise its right to opt out of a program or to terminate the licensing agreement, the development and commercialization of aldoxorubicin would be adversely affected, our potential for generating revenue from this program would be adversely affected and attracting new partners would be made more difficult.
Much of the

The potential revenue from our existing and future arrangement with NantCell will consist ofZevra and ImmunityBio is based on contingent payments, such as payments for achieving development and commercialization milestones and royalties payable on commercial sales of successfully developed aldoxorubicin.  The milestone, royalty and other revenue that we may receive under this arrangementwhich will depend upon our, and NantCell'stheir ability to achieve regulatory approvals and successfully develop, introduce, market and sell products derived from arimoclomol and aldoxorubicin. We will not be directly involved in this process and will depend entirely on NantCell,Zevra and ImmunityBio, which may fail to develop or effectively commercialize products derived from arimoclomol and aldoxorubicin, becauserespectively, for many reasons, including if they:

·

decide not to devote the necessary resources due to internal constraints, such as limited personnel with the requisite scientific expertise, limited cash resources or specialized equipment limitations, or the belief that other drug development programs may have a higher likelihood of obtaining regulatory approval or may potentially generate a greater return on investment;

● do not have sufficient resources necessary to carry arimoclomol or aldoxorubicin through clinical development, regulatory approval and commercialization;

● cannot obtain the necessary regulatory approvals for arimoclomol or aldoxorubicin; or

● decide to pursue a competitive drug candidate.

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·do not have sufficient resources necessary to carry aldoxorubicin through clinical development, regulatory approval and commercialization;
·cannot obtain the necessary regulatory approvals for aldoxorubicin; or
·decide to pursue a competitive drug candidate.

If NantCell failsZevra or ImmunityBio do not obtain the applicable regulatory approvals for arimoclomol or aldoxorubicin that are necessary to trigger the corresponding milestone payments to us under our the Royalty Agreement and the Assignment Agreement, if their research and development or commercialization efforts are, otherwise, unsuccessful, or if they fail to develop or effectively commercialize arimoclomol or aldoxorubicin or for any of the other reasons described above, we may not be able to develop and commercialize that drug independently or replace NantCellZevra or ImmunityBio with another suitable partner in a reasonable period of time, and on commercially reasonable terms, if at all.

CytRx 2017 10-K Page #11#

we will not realize the anticipated commercial benefits of the arrangement which could adversely affect our business prospects and financial condition.

Risks Associated With Drug Discovery and Development

If we do not achieve ourthe projected development goals for our product candidates are not achieved in the expected time frames, we estimate, the commercialization of our products may be delayed and our business prospects may suffer. Our financial projections also may prove to be materially inaccurate.

From time to time, we estimate the timing of the accomplishment of various scientific, clinical, regulatory and other product development goals, which we sometimes refer to as milestones. These milestones may include the commencement or completion of scientific studies and clinical trials and the submission of regulatory filings.

We also may disclose projected expenditures or other forecasts for future periods. These and other financial projections are based on management'smanagement’s current expectations and do not contain any margin of error or cushion for any specific uncertainties, or for the uncertainties inherent in all financial forecasting.

The actual timing of milestones and actual expenditures or other financial results can vary dramatically compared to our estimates, in some cases for reasons beyond our control.control or the control of companies that have licensed or purchased our product candidates. If we do not meetthese milestones or financial projections as announced from time to time,are not met, the development and commercialization of our productsproduct candidates may be delayed and our business prospects may suffer. The assumptions management has used to produce these projections may significantly change or prove to be inaccurate. Accordingly, you should not unduly rely on any of these financial projections.

The regulatory approval process is lengthy, time consuming and inherently unpredictable, and if our products or those we have sold or licensed are not successfully developed and approved by the FDA or foreign regulatory authorities, we may be forced to reduce or curtail our operations.

All of our product candidates in development or those licensed or sold must be approved by the FDA or corresponding foreign governmental agencies before they can be marketed. The process for obtaining FDA and foreign government approvals is both time-consuming and costly, with no certainty of a successful outcome. This process typically includes the conduct of extensive pre-clinical and clinical testing, including post-approval testing, which may take longer or cost more than we or our licensees, if any, anticipate, and may prove unsuccessful due to numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate'scandidate’s clinical development and may vary among jurisdictions. WeNone of our product candidates in development or licensed or sold to third parties have not obtainedreceived regulatory approval for any product candidate.

approval.

Numerous factors could affect the timing, cost or outcome of our product development efforts, including the following:

·difficulty in enrolling patients in conformity with required protocols or projected timelines;
·
requirements for clinical trial design imposed by the FDA;
·
unexpected adverse reactions by patients in trials;

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·difficulty in obtaining clinical supplies of the product;
·
changes in or our inability to comply with FDA or foreign governmental product testing, manufacturing or marketing requirements;
·
regulatory inspections of clinical trials or manufacturing facilities, which may, among other things, require us or our manufacturers or licensees to undertake corrective action or suspend or terminate the affected clinical trials if investigators find them not to be in compliance with applicable regulatory requirements;
·
inability to generate statistically significant data confirming the safety and efficacy of the product being tested;
·
modification of the product during testing; and
·
reallocation of our limited financial and other resources to other clinical programs.

It is possible that none of the product candidates we develop or have sold or licensed will obtain the regulatory approvals necessary for us to begin selling them.them or making us eligible to receive milestone or royalty payments. The time required to obtain FDA and foreign governmental approvals is unpredictable, but often can take years following the commencement of clinical trials, depending upon the complexity of the product candidate. Any analysis we performperformed on data from clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval. In addition, even if we were to obtainregulatory approval was obtained, regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request,requested, may not approve the intended price we intend to charge for oursuch products, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for ourthe product candidates.

CytRx 2017 10-K Page #12#

candidates that we develop, have sold or licensed.

Furthermore, even if we obtain regulatory approvals are obtained, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, import, export, advertising, promotion and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with current good manufacturing practices or cGMPs,(“cGMPs”), and good clinical practices or cGCPs,(“cGCPs”), for any clinical trials that we conduct post-approval. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

·restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product recalls;
·
fines, warning letters or holds on clinical trials;
·
refusal by the FDA to approve pending applications or supplements to approved applications filed by us or our strategic partners, or suspension or revocation of product license approvals;
·
product seizure or detention, or refusal to permit the import or export of products; and
injunctions or the imposition of civil or criminal penalties.

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The FDA'sFDA’s policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability, which would adversely affect our business. We will also be subject to periodic inspections and the potential for mandatory post- approval clinical trials required by the FDA and other U.S. and foreign regulatory authorities. Any delay or failure in obtaining required approvals or to comply with post-approval regulatory requirements could have a material adverse effect on our ability to generate revenue from the particular product candidate. The failure to comply with any post-approval regulatory requirements also could result in the rescission of the related regulatory approvals or the suspension of sales of the offending product.

Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials. Product candidates in later stages of clinical development may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or safety profiles, notwithstanding promising results in earlier trials. For example, aldoxorubicin has shown encouraging preliminary clinical results in our Phase 2b clinical trial as a treatment for STS; however, theseSTS. These conclusions may not be reproduced in future clinical trial results; forresults. For instance, the Phase 3 pivotal clinical trial testing aldoxorubicin as a treatment for STS narrowly missed statistical significance although it demonstrated a statistically significant improvement in PFS over investigator'sinvestigator’s choice in 312 patients treated in North America plus Australia .and Australia. Accordingly, our development partner may ultimately be unable to provide the FDA and/or other U.S. and foreign regulatory authorities with satisfactory data on clinical safety and efficacy sufficient to obtain approval from the FDA approval of aldoxorubicin for any indication.

Further wedelays may experience delaysoccur in clinical trials of our product candidates. We do not know whether ongoing clinical trials will be completed on schedule or at all, or whether planned clinical trials will begin on time, need to be redesigned, enroll patients on time or be completed on schedule, if at all. Clinical trials can be delayed for a variety of reasons, including delays related to:

·obtaining regulatory approval to commence a trial;
·
reaching agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;
·
obtaining institutional review board approval at each clinical trial site;
·
recruiting suitable patients to participate in a trial;
·
having patients complete a trial or return for post-treatment follow-up;
·
clinical trial sites deviating from trial protocol or dropping out of a trial;
·
adding new clinical trial sites; or
·
manufacturing sufficient quantities of product candidate for use in clinical trials.

CytRx 2017 10-K Page #13#

Our SPA with the FDA for our pivotal study of aldoxorubicin does not guarantee marketing approval in the U.S.
We have an SPA with the FDA for the pivotal trial of aldoxorubicin for the treatment of STS. The SPA means that the FDA agrees that the design and analyses proposed in a protocol are acceptable to support regulatory approval of the product candidate with respect to effectiveness of the indication studied. However, an SPA agreement does not guarantee approval of a product candidate, and even if the FDA agrees to the design, execution, and analysis proposed in protocols reviewed under the SPA process, the FDA may revoke or alter its agreement in certain circumstances. In particular, an SPA agreement is not binding on the FDA if public health concerns emerge that were unrecognized at the time of the SPA agreement, other new scientific concerns regarding product safety or efficacy arise, the sponsor fails to comply with the agreed upon trial protocols, or the relevant data, assumptions or information provided by the sponsor in a request for the SPA change or are found to be false or omit relevant facts. In addition, even after an SPA agreement is finalized, the SPA agreement may be modified, and such modification will be deemed binding on the FDA review division, except under the circumstances described above, if the FDA and the sponsor agree in writing to modify the protocol and such modification is intended to improve the study. The FDA retains significant latitude and discretion in interpreting the terms of the SPA agreement and the data and results from any study that is the subject of the SPA agreement. Moreover, a final determination that the agreed-upon protocol satisfies a specific objective, such as the demonstration of efficacy and safety (positive benefit-risk ratio), or supports an approval decision, will be based on a complete review of all the data submitted to the FDA.
We rely on third parties to conduct our preclinical and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we and our collaborators may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.
We have agreements with third-party CROs to monitor and manage data for our preclinical and clinical programs. We rely heavily on these parties for execution of our preclinical and clinical trials, and control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on CROs does not relieve us of our regulatory responsibilities. We and our CROs are required to comply with cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for products in clinical development. Regulatory authorities enforce these cGCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If we or any of these CROs fails to comply with applicable cGCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that, upon inspection, such regulatory authorities will determine that any of our clinical trials comply with the cGCP regulations. In addition, our clinical trials must be conducted with product produced under cGMP regulations, and will require a large number of test subjects. Our or our CROs' failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process.
If any of our relationships with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs or to do so on commercially reasonable terms. In addition, our CROs are not our employees, and except for remedies available to us under our agreements with such CROs, we cannot control whether or not they devote sufficient time and resources to our ongoing preclinical and clinical programs. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. As a result, our financial results and the commercial prospects for aldoxorubicin would be harmed, our costs could increase and our ability to generate revenues could be delayed.
Switching or adding additional CROs involves substantial cost and requires extensive management time and focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects

We rely upon third parties for the manufacture of our clinical product supplies, and we intend to rely on third parties to produce commercial supplies of any approved product candidate, and our commercialization of any product candidates could be stopped, delayed or made less profitable if those third parties fail to obtain approval of the FDA, fail to provide us with sufficient quantities of drug product or fail to do so at acceptable quality levels or prices.
We do not have the facilities or expertise to manufacture any of our other product candidates, and we lack the resources and capability to manufacture any of our product candidates on a clinical or commercial scale. Accordingly, we are dependent upon third-party manufacturers, or potential future strategic alliance partners, to manufacture these supplies. Our failure to secure arrangements as needed could have a materially adverse effect on our ability to complete the development of our future products or to commercialize them.
The facilities used by our contract manufacturers to manufacture our product candidates must be approved by the FDA pursuant to inspections that will be completed after we submit our NDA to the FDA. We do not control the manufacturing process of aldoxorubicin and are completely dependent on our contract manufacturing partners for compliance with the FDA's requirements for manufacture of aldoxorubicin. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the FDA's strict regulatory requirements, they will not be able to secure and/or maintain FDA approval for the manufacturing facilities. In addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates.
CytRx 2017 10-K Page #14#

We may be unable to protect our intellectual property rights, which could adversely affect our ability to compete effectively.

We will be able to protect our technologies from unauthorized use by third parties only to the extent that we have rights to valid and enforceable patents or other proprietary rights that cover them. Although we have rights to patents and patent applications directed to our product candidates, these patents and applications may not prevent third parties from developing or commercializing similar or identical technologies. In addition, our patents may be held to be invalid if challenged by third parties, and our patent applications may not result in the issuance of patents.

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The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. No consistent policy regarding the breadth of claims allowed in biotechnology patents has emerged to date in the United States and in many foreign countries. The application and enforcement of patent laws and regulations in foreign countries is even more uncertain. Accordingly, we may not be able to effectively file, protect or defend our proprietary rights on a consistent basis. Many of the patents and patent applications on which we rely were issued or filed by third parties prior to the time we acquired rights to them. The validity, enforceability and ownership of those patents and patent applications may be challenged, and if a court decides that our patents are not valid, we will not have the right to stop others from using our inventions. There is also the risk that, even if the validity of our patents is upheld, a court may refuse to stop others on the ground that their activities do not infringe our patents.

Any litigation brought by us to protect our intellectual property rights could be costly and have a material adverse effect on our operating results or financial condition, make it more difficult for us to enter into strategic alliances with third parties to develop our products, or discourage our existing licensees from continuing their development work on our potential products. If our patent coverage is insufficient to prevent third parties from developing or commercializing similar or identical technologies, the value of our assets is likely to be materially and adversely affected.

Moreover, we may be subject to a third-party pre-issuance submission of prior art or become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our patent rights or the patent rights of others. The costs of defending our patents or enforcing our proprietary rights in post-issuance administrative proceedings and litigation can be substantial and the outcome can be uncertain. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

We have not pursued or maintained, and may not pursue or maintain in the future, patent protection for our product candidates in every country or territory in which we may sell our products, if approved. The laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third parties from infringing our patents in all countries outside the United States, or from selling or importing products that infringe our patents in and into the United States or other jurisdictions.

Indeed, several companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of some countries do not favor the enforcement of patents and other intellectual property rights, which could make it difficult for us to stop the infringement, misappropriation or other violation of our intellectual property rights generally. Proceedings to enforce our intellectual property rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.

Furthermore, the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or in patent claims being narrowed, invalidated or held unenforceable, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and product candidates. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

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Moreover, the scope claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. Changes in either the patent laws or interpretation of the patent laws may diminish the value of our or our collaborators’ patents or narrow the scope of such patent protection and could increase the uncertainties and costs surrounding the prosecution of our or any future collaborators’ patent applications and the enforcement or defense of any issued patents. Even if the patent applications we license or own do issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors or other third parties from competing with us or otherwise provide us with any competitive advantage. Our competitors or other third parties may be able to circumvent our patents by developing similar or alternative products in a non-infringing manner.

Some of our technologies and processes do not fulfill the requirements for patent or trademark protection or are not protected by patent or trademark rights for other reasons, e.g., secrecy. We therefore also rely on certain proprietary trade secrets and know-how, especially where we believe patent protection is not appropriate or obtainable. However, tradeTrade secrets and know-how are difficult to protect. Although we have taken measures to protect our unpatented trade secrets and know-how, including the use of confidentiality and invention assignment agreements with our employees, consultants and some of our contractors, it is possible that these persons may disclose our trade secrets or know-how or that our competitors may independently develop or otherwise discover our trade secrets and know-how.


There is no guarantee, however, that such agreements will not be breached, that they will provide sufficient protection for our business secrets and proprietary information or that adequate remedies will be available in the event of an unauthorized use or disclosure of such information. It cannot be excluded that we do not have, or cannot enforce, legal remedies that are effective at economically acceptable costs. Further, the violation of a non-disclosure agreement might be difficult to prove because business secrets and know- how may be developed independently by, or become otherwise known to, third parties. In addition, it may be difficult to quantify the damages which have occurred and to obtain legal remediation, or to undo the damages caused, by legal remedies. Our failure to effectively protect our business secrets and know-how could have material adverse effects on our business, prospects, financial condition and results of operations.

If our product candidates infringe or otherwise violate the rights of others, we could be subject to expensive litigation or be required to obtain licenses from others to develop or market them.

Our commercial success also depends upon our ability, and the ability of any third party with which we may partner, to develop, manufacture, market and sell our product candidates and/or products, if approved, and use our patent-protected technologies without infringing the patents of third parties. There is considerable patent litigation in the biotechnology and pharmaceutical industries. As the biopharmaceutical industry expands and more patents are issued, we face increased risks that there may be patents issued to third parties that relate to our product candidates and technology of which we are not aware or that we must challenge to continue our operations as currently contemplated.

Our competitors or others may have patent rights that they choose to assert against us or our licensees, suppliers, customers or potential collaborators. Moreover, we may not know about patents or patent applications that our products would infringe. For example, because patent applications do not publish for at least 18 months, if at all, and can take many years to issue, there may be currently pending applications unknown to us that may later result in issued patents that our product candidates would infringe. In addition, if third parties file patent applications or obtain patents claiming technology also claimed by us or our licensors in issued patents or pending applications, we may have to participate in interference proceedings in the U.S. Patent and Trademark Office to determine priority of invention. If third parties file oppositions in foreign countries, we may also have to participate in opposition proceedings in foreign tribunals to defend the patentability of our foreign patent applications.

If a third-party claims that we are infringing on its proprietary rights, any of the following may occur:

·we may become involved in time-consuming and expensive litigation, even if the claim is without merit;
·
we may become liable for substantial damages for past infringement if a court decides that our technology infringes a competitor'scompetitor’s patent;

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·a court may prohibit us from selling or licensing our product without a license from the patent holder, which may not be available on commercially acceptable terms, if at all, or which may require us to pay substantial royalties or grant cross licenses to our patents; and
·
we may have to redesign our product candidates or technology so that it does not infringe patent rights of others, which may not be possible or commercially feasible.

If any of these events occurs, our business and prospects will suffer and the market price of our common stock will likely decline substantially.

Obtaining and maintaining patent protection depends on compliance with various procedures and other requirements, and our patent protection could be reduced or eliminated in case of non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to the relevant patent agencies in several stages over the lifetime of the patents and /or applications. The relevant patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent application process. In many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are situations in which the failure to comply with the relevant requirements can result in the abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our competitors might be able to use our technologies and know-how which could have a material adverse effect on our business, prospects, financial condition and results of operation.

If we fail to comply with our obligations under our license agreements, we could lose the rights to intellectual property that is important to our business.

Our current license agreements impose on us various development obligations, payment of royalties and fees based on achieving certain milestones as well as other obligations. If we fail to comply with our obligations under these agreements, the licensor may have the right to terminate the license. In addition, if the licensor fails to enforce its intellectual property, the licensed rights may not be adequately maintained. The termination of any license agreements or failure to adequately protect such license agreements could prevent us from commercializing our product candidates or possible future products covered by the licensed intellectual property. Any of these events could materially adversely affect our business, prospects, financial condition and results of operation.

We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

Our employees may have been previously employed at other companies in the industry, including our competitors or potential competitors. Although we are not aware of any claims currently pending against us, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of the former employers of our employees. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management. If we fail in defending such claims, in addition to paying money claims, we may lose valuable intellectual property rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize product(s), which would materially adversely affect our commercial development efforts.

The results of pre-clinical studies or early clinical trials are not necessarily predictive of future results, and our ultra-high potency albumin-binding drug conjugates may not have favorable results in later clinical trials or receive regulatory approval.

Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will generate adequate data to demonstrate the efficacy and safety of our ultra-high potency albumin-binding drug conjugates. A number of companies in the pharmaceutical and biotechnology industries, including those with greater resources and experience than we have, have suffered significant setbacks in clinical trials, even after seeing promising results in earlier clinical trials. Despite the results reported in earlier preclinical trials for our ultra-high potency albumin-binding drug conjugates, weWe do not know whether the clinical trials we may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market them in any particular jurisdiction. If our clinical trials do not produce favorable results, our ability to achieve regulatory approval for these drug candidates will be adversely impacted and the value of our stock may decline.

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CytRx 2017 10-K Page #15#

The successful commercialization of our product candidates that are approved for marketing in the United States, if any, and/or any other products that we or our partners may commercialize in the future will likely depend, in-part, on the coverage and reimbursement policies of third-party payors, which, if unfavorable, could have a material adverse effect on our business.

The commercial success of our product candidates that are approved for marketing in the United States, if any, as well as any other products that we may or our partners may commercialize in the future, may depend, in significant part, on the extent to such products will be covered and reimbursed by third-party payors, including government healthcare programs, such as Medicare and Medicaid, private insurers, and managed care organizations. Patients for whom prescription drugs are prescribed and prescribing practitioners generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Without adequate coverage and reimbursement, patients and providers are unlikely to use or prescribe any products that we or our partners may commercialize or from which we may, otherwise, generate revenue in connection with commercial sales.

There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products. In the United States, there is no uniform policy of coverage and reimbursement. Accordingly, third-party payors, including private insurers and governmental payors, such as Medicare and Medicaid, play an important role in determining the extent to which new drugs and biologics will be covered and reimbursed. The Medicare program covers certain individuals aged 65 or older, as well as certain people under 65 with disabilities and individuals suffering from end-stage renal disease. The Medicaid program, which varies from state-to-state, covers eligible individuals and families who have limited financial means. The Medicare and Medicaid programs are increasingly used as models for how private payors and other governmental payors develop their coverage and reimbursement policies for drugs and biologics. It is difficult to predict at this time what third-party payors will decide with respect to the coverage and reimbursement for our product candidates and any other products we or our partners may commercialize or to which we may have commercialization rights or interests.

Third-party payors may deny coverage or reimbursement if they determine that a medical product was not used in accordance with cost-effective treatment methods, as determined by the third-party payor, and most, if not all, payors will deny coverage for products used or administered for an unapproved indication. Third-party payors also typically refuse to cover and reimburse for experimental procedures and devices. Furthermore, third-party payors are increasingly challenging the prices charged for medical products and services. And, the U.S. government and state legislatures have shown significant interest in implementing healthcare cost-containment programs, including price controls, restrictions on reimbursement, discount and rebate requirements, and requirements for substitution of generic products. Such measures, and the enactment of any more restrictive updates thereto and/or new measures could further limit our potential profitability and commercial success in connection with any products we or our partners may market in the United States. We cannot predict whether, or the extent to which, government and/or private payors will cover any products we or our partners may commercialize in the future, and there can be no assurances that such coverage and reimbursement levels, as applicable, will be sufficient to allow us to profit from the commercial sale of such product(s) in light of our costs from development and other related activities and any current or future arrangements with our development and/or commercialization partners.

Any products that we develop or are sold or licensed may become subject to unfavorable pricing regulations and/or third-party coverage and reimbursement policies, which could have a material adverse effect on our business.

We intend

Our product candidates are intended to sell our products that may be approved for marketingmarketed primarily to hospitals, which generally receive reimbursement for the health care services they provide to their patients from third-party payors, such as Medicare, Medicaid and other domestic and international government programs, private insurance plans and managed care programs.

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We currently expect that any

Such drugs we develop maywill likely need to be administered under the supervision of a physician. Under currently applicable law, drugs that are not usually self-administered may be eligible for coverage by the Medicare program if:

·they are "incidental"“incidental” to a physician'sphysician’s services;
·
they are "reasonable“reasonable and necessary"necessary” for the diagnosis or treatment of the illness or injury for which they are administered according to accepted standard of medical practice;
·
they are not excluded as immunizations; and
·
they have been approved by the FDA.

There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products. In the United States, third-party payors, including private and governmental payors, such as the Medicare and Medicaid programs, play an important role in determining the extent to which new drugs and biologics will be covered and reimbursed. The Medicare program covers certain individuals aged 65 or older, disabled or suffering from end-stage renal disease. The Medicaid program, which varies from state-to-state, covers certain individuals and families who have limited financial means. The Medicare and Medicaid programs increasingly are used as models for how private payors and other governmental payors develop their coverage and reimbursement policies for drugs and biologics. It is difficult to predict at this time what third-party payors will decide with respect to the coverage and reimbursement for our product candidates.

Most third-party payors may deny coverage or reimbursement if they determine that a medical product was not used in accordance with cost-effective treatment methods, as determined by the third-party payor, or was used for an unapproved indication. Third-party payors also may refuse to cover and reimburse for experimental procedures and devices. Furthermore, because our programs are in the early stages of development, we are unable at this time to determine their cost-effectiveness and the level or method of reimbursement. Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices, and are challenging the prices charged for medical products. If the price we are able to charge for any products we develop is inadequate in light of our development and other costs, our profitability could be adversely affected.

Healthcare legislative reform measures could hinder or prevent the commercial success of our products and product candidates.

In the United States, there have been, and we expect there will continue to be, a number of legislative and regulatory changes to the healthcare system that could affect our future revenues and profitability. Federal and state lawmakers regularly propose and, at times, enact legislation that results in significant changes to the healthcare system, some of which are intended to contain or reduce the costs of medical products and services. For example, in March 2010, the Patient Protection and Affordable Care Act (the “ACA”), as amended by the Health Care and Education Reconciliation Act, or collectively, the Affordable Care Act,“Healthcare Reform Law,” became law in the United StatesStates. It contains a number of provisions regarding health insurance, the provision of healthcare, conditions to reimbursement for healthcare services provided to Medicare and Medicaid patients, and other healthcare policy reforms. Through the law-making process, substantial changes have been and continue to be made to the current system for paying for healthcare in the United States, including changes made to extend medical benefits to certain Americans who lacked insurance coverage and to contain or reduce healthcare costs (such as by reducing or conditioning reimbursement amounts for healthcare services and drugs, and imposing additional taxes, fees, and rebate obligations on pharmaceutical and medical device companies). This legislation was one of the most comprehensive and significant reforms ever experienced by the United States in the healthcare industry and has significantly changed the way healthcare is financed by both governmental and private insurers. This legislation has impacted the scope of healthcare insurance and incentives for consumers and insurance companies, among others. Additionally, the Healthcare Reform Law’s provisions were designed to encourage providers to find cost savings in their clinical operations. Pharmaceuticals represent a significant portion of the cost of providing care. This environment has caused changes in the purchasing habits of consumers and providers and resulted in specific attention to the pricing negotiation, product selection and utilization review surrounding pharmaceuticals. This attention may result in any products we may commercialize or promote in the future, and/or our therapeutic candidates, as applicable, being chosen less frequently or subject to substantially lowered pricing.

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These structural changes could entail further modifications to the existing system of private payors and government programs (such as Medicare, Medicaid, and the State Children’s Health Insurance Program), creation of government-sponsored healthcare insurance sources, or some combination of both, as well as other changes. Restructuring the coverage of medical care in the U.S. could impact the reimbursement for prescribed drugs and pharmaceuticals, including our current commercial products, those we and our development or commercialization partners are currently developing or those that we may commercialize or promote in the future. If reimbursement for the products we currently commercialize or promote, any product we may commercialize or promote, or approved therapeutic candidates is substantially reduced or otherwise adversely affected in the future, or rebate obligations associated with them are substantially increased, it could have a material adverse effect on our reputation, business, financial condition or results of operations.

Further, there has been heightened governmental scrutiny over the manner in which drug manufacturers set prices for their marketed products, which have resulted in several recent Congressional inquiries and proposed and enacted bills designed to, among other things, bring more transparency to prescription drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. In addition, the United States government, state legislatures, and foreign governments have shown significant interest in implementing drug cost containment programs, including price-controls, restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs to limit the growth of government paid health care costs. For example, the United States government has passed legislation requiring pharmaceutical manufacturers to provide rebates and discounts to certain entities and governmental payors to participate in federal healthcare programs. Further, Congress and the current administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs, and the current administration recently released a “Blueprint”, or plan, to reduce the cost of drugs. The current administration’s Blueprint contains certain measures that the U.S. Department of Health and Human Services is already working to implement. Individual states in the United States have also been increasingly passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

We anticipate there will continue to be proposals by legislators at both the federal and state levels, regulators and commercial payers to reduce prescription drug costs while expanding individual healthcare benefits. Additional changes that may affect our business include those governing enrollmentsenrollment in federal healthcare programs, reimbursement changes, and fraud and abuse measures, all of which will impact existing government healthcare programsenforcement, and will result in the developmentexpansion of new programs. programs, such as Medicare payment for performance initiatives. The Affordable Care Act, among other things, (i) increasesultimate implementation of any healthcare reform legislation and any new laws and regulations, and its impact on us, is impossible to predict. Any significant reforms made to the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program, extends the rebate program to individuals enrolled in Medicaid managed care organizations, and addresses new methodologies by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, and for drugs that are line extension products; (ii) establishes annual fees and taxes on manufacturers of certain branded prescription drugs, and (iii) enacts a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer's outpatient drugs to be covered under Medicare Part D.

In addition, other legislative changes have been proposed and adoptedhealthcare system in the United States, since the Affordable Care Act was enacted. On August 2, 2011, the Budget Control Act of 2011 amongor in other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation's automatic reduction to several government programs. This includes aggregate reductions of Medicare payments to providers up to 2% per fiscal year, which went intojurisdictions, may have an adverse effect on April 1, 2013. On January 2, 2013, the American Taxpayer Relief Actour business, financial condition, results of 2012 was signed into law, which, among other things, further reduced Medicare payments to several providers, including hospitals, imaging centersoperations and cancer treatment centers. We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for our products once approved or additional pricing pressures.
CytRx 2017 10-K Page #16#


prospects.

We may also be subject to federal and state healthcare laws regulation and enforcementregulations relating to our current and/or future operations, and our failure to comply with those laws could adversely affect our business, operations and financial condition.

If we obtain FDA approval for any of our product candidates and begin commercializing those products in the United States, our operations may be directly, or indirectly through our customers, subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute, the federal False Claims Act, and physician sunshine laws and regulations. These laws may impact, among other things, our proposed sales, marketing, and education programs. In addition, we may be subject to patient privacy regulation by both the federal government and the states in which we conduct our business. The laws that may affect our ability to operate include:

·the federal Anti-Kickback Statute, which prohibits, among other things, any person from knowingly and willfully offering, soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;

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·the federal False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, false claims, or knowingly using false statements, to obtain payment from the federal government, and which may apply to entities that provide coding and billing advice to customers;
·
federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
·
the federal physician sunshine requirements under the Affordable Care Act, which requires manufacturers of drugs, devices, biologics, and medical supplies to report annually to the Centers for Medicare & Medicaid Services information related to payments and other transfers of value to physicians, other healthcare providers, and teaching hospitals, and ownership and investment interests held by physicians and other healthcare providers and their immediate family members;

·the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information; and
·
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry'sindustry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. For instance, the California Consumer Privacy Act, or the CCPA, became effective on January 1, 2020. The CCPA gives California residents expanded rights to access and delete their personal information, opt out of certain personal information sharing and receive detailed information about how their personal information is used by requiring covered companies to provide new disclosures to California consumers (as that term is broadly defined) and provide such consumers new ways to opt-out of certain sales of personal information. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation. Although there are limited exemptions for clinical trial data and the CCPA’s implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future, the CCPA may increase our compliance costs and potential liability. Many similar privacy laws have been proposed at the federal level and in other states.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. In addition, recent health care reform legislationthe federal government has strengthened these laws. For example,identified relationships between drug companies (and other medical-product manufacturers) and healthcare providers as particularly susceptible to fraud and abuse and, thus, our relationships may be subject to heightened regulatory scrutiny, particularly once we have one or more products on the recently enacted Affordable Care Act, among other things, amends the intent requirementU.S. market, if ever. Further, many of the Federal Anti-Kickback Statuteapplicable healthcare laws and criminal healthcare fraud statutes. A person regulations are subject to varying and/or entity no longer needs to have actual knowledge of the statute or specific intent to violate it. In addition, the Affordable Care Act provides that the government may assert that a claim including items or services resulting from a violation of the Federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.

evolving interpretations, which makes achieving and maintaining consistent compliance more difficult.

Achieving and sustaining compliance with these laws may prove costly. In addition, any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management'smanagement’s attention from the operation of our business. If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, the exclusion from participation in federal and state healthcare programs, imprisonment, or the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results.

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We will be required to pay substantial milestone and other payments relating to the commercialization of our products.

The agreement relating to our worldwide rights to arimoclomol provides for our payment of up to an aggregate of $3.65 million upon receipt of milestone payments from Orphayzme A/S. On May 31, 2022, Orphazyme announced that it had completed the sale of substantially all of its assets and business activities for cash consideration of $12.8 million and assumption of liabilities estimated to equal approximately $5.2 million to KemPharm, a specialty biopharmaceutical company focused on the discovery and development of novel treatments for rare CNS diseases. As part of the KemPharm Transaction, all of Orphazyme’s obligations to LadRx under the 2011 Arimoclomol Agreement, including with regard to milestone payments and royalties on sales, were assumed by KemPharm.

As part of the Royalty Purchase Agreement entered into with XOMA in June 2023, XOMA assumes all but $0.4 million of the payment due under the preceding agreement.

The COVID-19 endemic and its ongoing effects could adversely impact our business and prospects, including active and planned clinical trials by ImmunityBio and Zevra.

In May 2023, the World Health Organization determined that COVID-19 no longer fit the definition of a public health emergency and the declaration of a public health emergency associated with COVID-19 subsequently expired on May 11, 2023.

As the COVID-19 endemic and its ongoing effects continue to evolve, the companies which we are working to develop and commercialize our products, ImmunityBio and Zevra, could be materially and adversely affected by the risks, or the public perception of the risks, related to the COVID-19 endemic and its ongoing effects, including but not limited to, reinstatement of government-imposed quarantines, limitations on business activity and shelter-in-place mandates to mitigate or contain the virus, which could cause delays in our potential timing of receipts of milestones and royalties within the disclosed time periods and expected costs. The disruptions to ImmunityBio and Zevra could include:

delays or difficulties in recruiting and enrolling new patients in their clinical trials;
delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;
diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as their clinical trial sites and hospital staff supporting the conduct of their clinical trials;
interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others;
limitations in employee resources that would otherwise be focused on the conduct of their clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;
interruption in global shipping that may affect the transport of clinical trial supplies and materials, such as investigational drug product used in their clinical trials;
delays in receiving approval from the FDA and local regulatory authorities to initiate their planned clinical trials;
changes in FDA and local regulation as part of a response to the COVID-19 coronavirus outbreak which may change the ways in which clinical trials are conducted of discontinue clinical trials altogether;
delays in necessary interactions with regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees;

CytRx 2017 10-K Page #17#
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delay in the timing of other interactions with the FDA due to absenteeism by federal employees or by the diversion of their efforts and attention to approval of other therapeutics or other activities related to COVID-19; and
refusal of the FDA to accept data from clinical trials in affected geographies outside the United States.

The extent to which the COVID-19 endemic and its ongoing effects may impact our business and prospects will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the endemic, new variants of the coronavirus, reinstatement of travel restrictions and social distancing in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.

In the event of a dispute regarding our international drug development, it may be necessary for us to resolve the dispute in the foreign country of dispute, where we would be faced with unfamiliar laws and procedures.

The resolution of disputes in foreign countries can be costly and time consuming, similar to the situation in the United States. In a foreign country, we face the additional burden of understanding unfamiliar laws and procedures. We may not be entitled to a jury trial, as we might be in the United States. Further, to litigate in any foreign country, we would be faced with the necessity of hiring lawyers and other professionals who are familiar with the foreign laws. For these reasons, we may incur unforeseen expenses if we are forced to resolve a dispute in a foreign country.

Drug discovery is a complex, time-consuming and expensive process, and we may not succeed in creating new product candidates.

Conducting drug discovery and pre-clinical development of our albumin-binding technology is a complex and expensive process that will take many years. Accordingly, we cannot be sure whether or when our drug discovery and pre-clinical development activities will succeed in developing any new product candidates. In addition, any product candidates that we develop in pre-clinical testing may not demonstrate success in clinical trials required for marketing approval.

Any deficiency in the design, implementation or oversight of our drug discovery and pre-clinical testing programs could cause us to incur significant additional costs, experience significant delays, prevent us from obtaining marketing approval for any product candidate that may result from these programs or abandon development of certain product candidates. If any of these risks materializes, it could harm our business and cause our stock price to decline.

General Risk Factors

We are subject to intense competition, and we may not compete successfully.

Many companies, including large pharmaceutical and biotechnology firms with financial resources, research and development staffs, and facilities that may be substantially greater than those of ours or our strategic partners or licensees, are engaged in the research and development of pharmaceutical products that could compete with our potential products. To the extent that we seek to acquire, through license or otherwise, existing or potential new products, we will be competing with numerous other companies, many of which will have substantially greater financial resources and large acquisition and research and development staffs that may give those companies a competitive advantage over us in identifying and evaluating these drug acquisition opportunities. Any products that we acquire will be competing with products marketed by companies that in many cases will have substantially greater marketing resources than we have. The industry is characterized by rapid technological advances and competitors may develop their products more rapidly and such products may be more effective than those currently under development or that may be developed in the future by our strategic partners or licensees. Competitive products for a number of the disease indications that we have targeted are currently being marketed by other parties, and additional competitive products are under development and may also include products currently under development that we are not aware of or products that may be developed in the future.

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As a result, these competitors may:

·succeed in developing competitive products sooner than us or our strategic partners or licensees;
·obtain FDA or foreign governmental approvals for their products before we can obtain approval of any of our products;
·

succeed in developing competitive products sooner than us or our strategic partners or licensees;

obtain FDA or foreign governmental approvals for their products before we can obtain approval of any of our products;

obtain patents that block or otherwise inhibit the development and commercialization of our product candidate candidates;

·develop products that are safer or more effective than our products;
·devote greater resources than us to marketing or selling products;
·introduce or adapt more quickly than us to new technologies and other scientific advances;
·introduce products that render our products obsolete;
·withstand price competition more successfully than us or our strategic partners or licensees;
·negotiate third-party strategic alliances or licensing arrangements more effectively than us; and
·take better advantage than us of other opportunities.
We will be required to pay substantial milestone and other payments relating to the commercialization of our products.
The agreement relatingproduct candidate candidates;

develop products that are safer or more effective than our products;

devote greater resources than us to our worldwide rightsmarketing or selling products;

introduce or adapt more quickly than us to aldoxorubicin provides for our payment of up to an aggregate of $7.5 million upon meeting specified clinical and regulatory milestones up to and including the product's second, final marketing approval. We also will be obliged to pay:

·commercially reasonable royalties based on a percentage of net sales (as defined in the agreement);
·a percentage of any non-royalty sub-licensing income (as defined in the agreement); and
·milestones of $1,000,000 for each additional final marketing approval that we might obtain.
Under the merger agreement by which we acquired Innovive, we agreed to pay the former Innovive stockholders a total of up to approximately $18.3 million of future earnout merger consideration, subject to our achievement of specified net sales under the Innovive license agreements. The earnout merger consideration, if any, will be payable in shares of our common stock, subject to specified conditions, or, at our election, in cash or by a combination of shares of our common stock and cash. Our common stock will be valued for purposes of any future earnout merger consideration based upon the trading price of our common stock at the time the earnout merger consideration is paid.
CytRx 2017 10-K Page #18#

We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity incidents, could harm our ability to operate our business effectively.
We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity incidents, could harm our ability to operate our business effectively. We maintain sensitive data pertaining to our Company on our computer networks, including information about our development activities, our intellectual propertynew technologies and other proprietary business information. Our internal computer systemsscientific advances;

introduce products that render our products obsolete;

withstand price competition more successfully than us or our strategic partners or licensees;

negotiate third-party strategic alliances or licensing arrangements more effectively than us; and those

take better advantage than us of third parties with which we contract may be vulnerable to damage from cyber-attacks, computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures, despite the implementation of security measures. System failures, accidents or security breaches could cause interruptions to our operations, including material disruption of our development activities, result in significant data losses or theft of our intellectual property or proprietary business information, and could require substantial expenditures to remedy. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications or inappropriate disclosure of confidential or proprietary information, we could incur liability and our development programs could be delayed, any of which would harm our business and operations.

other opportunities.

We are subject to potential liabilities from clinical testing and future product liability claims.

If any of our products are alleged to be defective, they may expose us to claims for personal injury by patients in clinical trials of our products or, if we obtain marketing approval and commercialize our products, by patients using our commercially marketed products. Even if one or more of our products is approved by the FDA, users may claim that such products caused unintended adverse effects. We maintain clinical trial insurance for our ongoing clinical trials, and we plan to seek to obtain similar insurance for any other clinical trials that we conduct. We also would seek to obtain product liability insurance covering the commercial marketing of our product candidates. We may not be able to obtain additional insurance, however, and any insurance obtained by us may prove inadequate in the event of a claim against us. Any claims asserted against us also may divert management'smanagement’s attention from our operations, and we may have to incur substantial costs to defend such claims even if they are unsuccessful.

We may be unable to successfully acquire additional technologies or products. If we require additional technologies or products, our product development plans may change and the ownership interests of our shareholders could be diluted.

We may seek to acquire additional technologies by licensing or purchasing such technologies, or through a merger or acquisition of one or more companies that own such technologies. We have no current understanding or agreement to acquire any technologies, however, and we may not be able to identify or successfully acquire any additional technologies. We also may seek to acquire products from third parties that already are being marketed or have been approved for marketing, although we have not currently identified any of these products. We do not have any prior experience in acquiring or marketing products approved for marketing and may need to find third parties to market any products that we might acquire.

We have focused our product development efforts on our oncology and neurodegenerative drug candidates, which we believe have the greatest revenue potential. If we acquire additional technologies or product candidates, we may determine to make further changes to our product development plans and business strategy to capitalize on opportunities presented by the new technologies and product candidates.

We may determine to issue shares of our common stock to acquire additional technologies or products or in connection with a merger or acquisition of another company. To the extent we do so, the ownership interest of our stockholders will be diluted accordingly.

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The impact and results of our exploration of any strategic alternatives are uncertain and may not be successful.

From time to time, we may consider strategic alternatives available to us to enhance shareholder value. Strategic alternatives could include acquisition transactions and/or strategic partnerships with one or more parties, the licensing of some of our proprietary technologies, or other possible transactions. Any strategic transaction that is completed ultimately may not deliver the anticipated benefits or enhance shareholder value. Further, we may devote a significant amount of our management resources to such a transaction, which could negatively impact our operations. We may incur significant costs in connection with seeking certain acquisitions or other strategic opportunities regardless of whether the transaction is completed, which could materially and adversely affect our liquidity and capital resources. In the event that we consummate an acquisition or strategic alternative in the future, there is no assurance that we would fully realize the potential benefits of such a transaction. Integration may be difficult and unpredictable, and acquisition-related integration costs, including certain non-recurring charges, could materially and adversely affect our results of operations. Moreover, integrating assets and businesses may significantly burden management and internal resources, including the potential loss or unavailability of key personnel. If we fail to successfully integrate any assets and businesses we acquire, we may not fully realize the potential benefits we expect, and our operating results could be adversely affected. If we pay for an acquisition in cash, it would reduce our cash available for operations or cause us to incur additional debt, and if we pay with our stock it could be dilutive to our stockholders.

CytRx 2017 10-K Page #19#

In

We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity incidents, could harm our ability to operate our business effectively.

We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity incidents, could harm our ability to operate our business effectively. We maintain sensitive data pertaining to our Company on our computer networks, including information about our development activities, our intellectual property and other proprietary business information. Our internal computer systems and those of third parties with which we contract may be vulnerable to damage from cyber-attacks, computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures, despite the implementation of security measures. System failures, accidents or security breaches could cause interruptions to our operations, including material disruption of our development activities, result in significant data losses or theft of our intellectual property or proprietary business information, and could require substantial expenditures to remedy. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications or inappropriate disclosure of confidential or proprietary information, we could incur liability and our development programs could be delayed, any of which would harm our business and operations.

Our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

Natural disasters could severely disrupt our operations or the operations of manufacturing facilities and have a material adverse effect on our business, financial condition, results of operations and prospects. If a natural disaster, power outage or other event occurred that prevented us from using all or a significant portion of our headquarters, that damaged critical infrastructure, such as manufacturing facilities, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time. The disaster recovery and business continuity plans we have in place currently are limited and may not prove adequate in the event of a dispute regardingserious disaster or similar event. We may incur substantial expenses as a result of the limited nature of our international drug development,disaster recovery and business continuity plans, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

Global, market and economic conditions may negatively impact our business, financial condition and share price.

Concerns over inflation, geopolitical issues, the U.S. financial markets, foreign exchange rates, capital and exchange controls, unstable global credit markets and financial conditions and the COVID-19 endemic and its ongoing effects, have led to periods of significant economic instability, declines in consumer confidence and discretionary spending, diminished expectations for the global economy and expectations of slower global economic growth going forward, and increased unemployment rates. Our general business strategy may be adversely affected by any such economic downturns, volatile business environments and continued unstable or unpredictable economic and market conditions. If these conditions continue to deteriorate or do not improve, it may bemake any necessary for usdebt or equity financing more difficult to resolve the dispute in the foreign country of dispute, where we would be faced with unfamiliar laws and procedures.

The resolution of disputes in foreign countries can becomplete, more costly, and time consuming, similar to the situation in the United States. However, inmore dilutive. In addition, there is a foreign country, we face the additional burdenrisk that one or more of understanding unfamiliar laws and procedures. We may not be entitled to a jury trial, as we might be in the United States. Further, to litigate in any foreign country, we would be faced with the necessity of hiring lawyersour current or future service providers and other professionals who are familiar with the foreign laws. For these reasons, we may incur unforeseen expenses if we are forcedpartners could be negatively affected by difficult economic times, which could adversely affect our ability to resolve a dispute in a foreign country.
Drug discovery is a complex, time-consumingattain our operating goals on schedule and expensive process, and we may not succeed in creating new product candidates.
Conducting drug discovery and pre-clinical development of our albumin-binding technology is a complex and expensive process that will take many years.  Accordingly, we cannot be sure whetheron budget or when our drug discovery and pre-clinical development activities will succeed in developing any new product candidates.  In addition, any product candidates that we develop in pre-clinical testing may not demonstrate success in clinical trials required for marketing approval.
Any deficiency in the design, implementation or oversight of our drug discovery and pre-clinical testing programs could cause us to incur significant additional costs, experience significant delays, prevent us from obtaining marketing approval for any product candidate that may result from these programs or abandon development of certain product candidates.  If any of these risks materializes, it could harmmeet our business and cause our stock price to decline.
We have a limited operating history in drug discovery, which is inherently risky, and we may not succeed in addressing these risks.
We have operated our drug discovery laboratory and LADR™ development program since October 2014. Accordingly, we have a limited operating history in conducting our own drug discovery programs. Consequently, there is limited information for investors to use as basis for assessing the viability of our drug discovery efforts.  Investors must consider the risks and difficulties inherent in drug discovery and pre-clinical activities, including the following:
financial objectives.

·difficulties, complications, delays and other unanticipated factors in connection with the development of new drugs;37
·competition from companies that have substantially greater assets and financial resources than we have;
·our ability

In addition, we face several risks associated with international business and are subject to global events beyond our control, including war, public health crises, such as endemics and epidemics, trade disputes, economic sanctions, trade wars and their collateral impacts and other international events. Any of these changes could have a material adverse effect on our reputation, business, financial condition or results of operations. There may be changes to anticipate and adapt to a competitive market and rapid technological developments;

·our need to rely on multiple levels of complex financing agreements with outside funding due to the length of drug development cycles and governmental approved protocols associated with the pharmaceutical industry; and
·our dependence upon key scientific personnel, including Felix Kratz, Ph.D., our Vice President of Drug Discovery.
We cannot be certain that we will successfully address these risks or that our drug discovery efforts will be successful.  In the event that we do not successfully address these risks, our business prospects,if there is instability, disruption or destruction in a significant geographic region, regardless of cause, including war, terrorism, riot, civil insurrection or social unrest; and natural or man-made disasters, including famine, flood, fire, earthquake, storm or disease. In February 2022, armed conflict escalated between Russia and Ukraine. The sanctions announced by the United States and other countries, following Russia’s invasion of Ukraine against Russia to date include restrictions on selling or importing goods, services or technology in or from affected regions and travel bans and asset freezes impacting connected individuals and political, military, business and financial organizations in Russia. The United States and other countries could impose wider sanctions and take other actions should the conflict further escalate. It is not possible to predict the broader consequences of this conflict, which could include further sanctions, embargoes, regional instability, geopolitical shifts and adverse effects on macroeconomic conditions, currency exchange rates and financial markets, all of which could impact our business, financial condition and results of operations could be materially and adversely affected.  operations.

We also may be requiredsubject to reduce or discontinue altogether our drug discovery and pre-clinical programs.

Our abilityinflationary risk

The Company does not believe that inflation has had a material effect on its operations to use our net operating loss carryforwards and certaindate, other tax attributes may be limited.

Under Section 382than the impact of inflation on the Internal Revenue Code of 1986, as amended, if a corporation undergoes an "ownership change," the corporation's ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes (such as research and development tax credits) to offset its post-change income and taxes may be limited. In general an "ownership change" occurs ifeconomy. However, there is a cumulative changerisk that the Company’s operating costs could become subject to inflationary pressures in the future, which would have the effect of increasing the Company’s operating costs, and which would put additional stress on the Company’s working capital resources.

We may not be successful in hiring and retaining key employees, which may harm our ownership by "5% shareholders"business.

Our business is highly dependent upon the continued services of our senior management and key personnel. As such, our future success depends on our ability to identify, attract, hire or engage, retain, and motivate well-qualified personnel. Our operations require qualified personnel with expertise in pharmaceutical development and clinical research. We must compete for qualified individuals with numerous companies, universities, and other research institutions. Competition for such individuals is intense, and, when the need arises, we may not be able to hire the personnel necessary to support our efforts. There can be no assurance that exceeds 50 percentage points over a rolling three-year period. Similar rules may apply under state tax laws. As a result of a previous ownership change, our annual utilization of approximately $136.8 million in federal net operating loss carryforwardsthese professionals will be substantially limited.  Ifavailable in the market, or that we experience ownership changeswill be able to retain existing professionals or to meet or to continue to meet their compensation requirements.

An overall tightening and increasingly competitive labor market in the U.S. employment market generally, especially in response to the COVID-19 endemic, has been observed in the United States. Sustained labor shortage or increased turnover rates within our employee base, caused by the COVID-19 endemic or as a result of future transactions in our stock, we may be further limited ingeneral macroeconomic factors, could lead to increased costs, such as increased overtime to meet demand and increased wage rates to attract and retain employees, and could negatively affect our ability to useefficiently operate and our net operating loss carryforwardsoverall business. If we are unable to hire and other tax assets to reduce taxes owed on the net taxable income that we earn. Any such limitations on the ability to use our net operating loss carryforwards and other tax assets could potentially result in increased future tax liability to us on any net income thatretain employees capable of performing at a high-level, or if mitigation measures we may earntake to respond to a decrease in labor availability, such as third-party outsourcing have unintended negative effects, our business could be adversely affected. An overall labor shortage, lack of skilled labor, increased turnover or labor inflation, caused by the future.

CytRx 2017 10-K Page #20#

Risks Associated with Our Common Stock
COVID-19 endemic or as a result of general macroeconomic factors, could have a material adverse impact on our operations, results of operations, liquidity or cash flows.

You may experience future dilution as a result of future equity offerings or other equity issuances.

To raise additional capital, we may in the future offer additional shares of our common stock, preferred stock or other securities convertible into or exchangeable for our common stock. We cannot assure you that we will be able to sell shares or other securities in any other offering at a price per share that is equal to or greater than the price per share that you may payhave paid for the sharesany of our common stock offered hereby.such securities that you currently hold. The price per share at which we sell additional shares of our common stock or other securities convertible into or exchangeable for our common stock in future transactions may be higher or lower than the price per share that you may payhave paid for thepreviously for shares of our common stock.


We To the extent we raise additional capital by issuing equity securities or obtaining borrowings convertible into equity, ownership dilution to existing stockholders may experience volatility in our stock price, whichresult and future investors may adversely affect the trading pricebe granted rights superior to those of our common stock.
The market price of our common stock in 2017 ranged from $1.65 to $6.00 per share, and it may continue to experience significant volatility from time to time. Factors that may affect the market price of our common stock include the following:
existing stockholders.

·announcements of interim or final results of our clinical trials or our drug discovery activities;38
·announcements of regulatory developments or technological innovations by us or our competitors;
·changes in our relationship with our licensors and other strategic partners;
·our quarterly operating results;
·litigation involving or affecting us;
·shortfalls in our actual financial results compared to our guidance or the forecasts of stock market analysts;
·developments in patent or other technology ownership rights;
·acquisitions or strategic alliances by us or our competitors;
·public concern regarding the safety of our products; and
·government regulation of drug pricing.

Our outstanding options, and warrants, convertible preferred shares, preferred investment option and the availability for resale of the underlying shares may adversely affect the trading price of our common stock.

As of December 31, 2017,2023, we had outstanding stock options to purchase 2,865,51214,000 shares of our common stock at a weighted-average exercise price of $10.62$501.70 per share and outstanding warrants to purchase 3,980,781up to an aggregate of 42 shares of common stock at a weighted-average exercise price of $4.26$3,360.00 per share. Our outstanding options and warrants could adversely affect our ability to obtain future financing or engage in certain mergers or other transactions, since the holders of options and warrants can be expected to exercise them at a time when we may be able to obtain additional capital through a new offering of securities on terms more favorable to us than the terms of outstanding options and warrants. For the life of the options and warrants, the holders have the opportunity to profit from a rise in the market price of our common stock without assuming the risk of ownership. The issuance of shares upon the exercise of outstanding options and warrants will also dilute the ownership interests of our existing stockholders. Many of our outstanding warrants contain anti-dilution provisions pertaining to dividends with respect to our common stock. In the event that these anti-dilution provisions are triggered by us in the future, we would likewise be required to reduce the exercise price, and increase the number of shares underlying, those warrants, which would have a dilutive effect on our stockholders.

We have registered with the SEC the resale by the holders of all or substantially allsome of the shares of our common stock issuable upon exercise or conversion (as applicable) of our outstanding options and warrants.convertible instruments. The availability of these shares for public resale, as well as actual resales of these shares, could adversely affect the trading price of our common stock.

CytRx 2017 10-K Page #21#

On July 27, 2022, at our 2022 Annual Meeting of Stockholders, the Company’s stockholders approved a proposal to authorize the Board, in its discretion but prior to July 26, 2023, to amend the Company’s Restated Certificate of Incorporation to effect a reverse stock split of all of the outstanding shares of the Company’s Common Stock, at a ratio in the range of 1-for-2 to 1-for-100, with such ratio to be determined by the Board, and all outstanding shares of Series D Preferred Stock were automatically redeemed. As a result, no shares of Series D Preferred Stock remain outstanding.

We cannot assure investors that our internal controls will prevent future material weaknesses.

Section 404 of the Sarbanes-Oxley Act requires, among other things, that we maintain effective internal controls for financial reporting and disclosure controls and procedures. We are required to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting. This assessment needs to include disclosure of any material weaknesses identified by our management in our internal control over financial reporting.

There can be no assurance that we will not suffer from material weaknesses in the future. If we fail to remediate these material weaknesses or fail to otherwise maintain effective internal controls over financial reporting in the future, such failure could result in a material misstatement of our annual or quarterly consolidated financial statements that would not be prevented or detected on a timely basis and which could cause investors and other users to lose confidence in our consolidated financial statements, limit our ability to raise capital and have a negative effect on the trading price of our common stock. Additionally, failure to remediate the material weaknesses or otherwise failing to maintain effective internal controls over financial reporting may also negatively impact our operating results and financial condition, impair our ability to timely file our periodic and other reports with the SEC, subject us to additional litigation and regulatory actions and cause us to incur substantial additional costs in future periods relating to the implementation of remedial measures.

We are subject to legal actions that could adversely affect our financial condition.

From time to time, we aremay be involved in legal proceedings that arise in the ordinary course of business. Securities-related class action and derivative lawsuits have often been brought against companies, including many biotechnology companies, which experience volatility in the market price of their securities. This risk is especially relevant for biotechnology and biopharmaceutical companies such as ours, which often experience significant stock price volatility in connection with their product development programs.

As described further in Item 3 of Part I of this Annual Report, our directors and certain of our officers are subject to stockholder derivative claims pending in the Delaware Court of Chancery and we and certain of our officers are subject to class-action complaints filed in the U.S. District Court for the Central District of California. Although we carry director's and officer's and other liability insurance, we

We must pay the first legal fees and other litigation expenses incurred up to the application retention, or deductible, amounts under our insurance policies, including our director’s and officer’s and other liability insurance policies, and the insurance may not be sufficient to cover all of the liabilities that we may incur in connection with the pending or possible future legal actions. As a result, the pending legal proceedings and any future legal actions may adversely affect out financial condition.

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Our anti-takeover measures may make it more difficult to change our management, or may discourage others from acquiring us, and thereby adversely affect stockholder value.

We have a stockholder rights plan and provisions in our amended and restated by-laws (the “Bylaws”), as amended, that are intended to protect our stockholders'stockholders’ interests by encouraging anyone seeking control of our company to negotiate with our board of directors.Board. These provisions may discourage or prevent a person or group from acquiring us without the approval of our board of directors,Board, even if the acquisition would be beneficial to our stockholders.

We have a classified board of directors,Board, which means that at least two stockholder meetings, instead of one, will be required to effect a change in the majority control of our board of directors.Board. This applies to every election of directors, not just an election occurring after a change in control. The classification of our board increases the amount of time it takes to change majority control of our board of directorsBoard and may cause potential acquirers to lose interest in a potential purchase of us, regardless of whether our purchase would be beneficial to us or our stockholders. The additional time and cost to change a majority of the members of our board of directors makes it more difficult and may discourage our existing stockholders from seeking to change our existing management in order to change the strategic direction or operational performance of our company.

At the 2022 Annual Meeting of Stockholders, a proposal (the “Declassification Proposal”) to declassify the structure of the Board was passed on a precatory basis, which advised the Board that a majority of our stockholders desired to end the classified Board structure in favor of the annual election of directors, in which each director standing for election will only be eligible to be elected for one-year terms.

At the 2023 Annual Meeting of Stockholders, the Board adopted a resolution approving and declaring the advisability of amending our governing documents to the extent necessary to remove provisions that provided for a classified Board. This proposal provides for a rolling declassification of the Board to be completed by the 2026 annual meeting of the stockholders.

Our by-lawsBylaws provide that directors may only be removed for cause by the affirmative vote of the holders of at least a majority of the outstanding shares of our capital stock then entitled to vote at an election of directors. This provision prevents stockholders from removing any incumbent director without cause. Our by-lawsBylaws also provide that a stockholder must give us at leastnot fewer than 120 days but not more than 150 days’ notice of a proposal or director nomination that such stockholder desires to present at any annual meeting or special meeting of our stockholders. Such provision prevents a stockholder from making a proposal or director nomination at a stockholder meeting without us having advance notice of that proposal or director nomination. This could make a change in control more difficult by providing our directors with more time to prepare an opposition to a proposed change in control. By making it more difficult to remove or install new directors, these bylawby-law provisions may also make our existing management less responsive to the views of our stockholders with respect to our operations and other issues such as management selection and management compensation.

We are subject to the anti-takeover provisions of Section 203 of the Delaware General Corporation Law,DGCL, which may also prevent or delay a takeover of us that may be beneficial to our stockholders.

CytRx 2017 10-K Page #22#

Our restated by-laws,Bylaws, as amended, designate the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders'stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.

Our by-lawsBylaws provide that, unless we consent in writing to an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee to us or our stockholders, (iii) any action asserting a claim arising pursuant to any provision of the Delaware General Corporation Law,DGCL, or (iv) any action asserting a claim that is governed by the internal affairs doctrine. Any person purchasing or otherwise acquiring any interest in any shares of our capital stock shall be deemed to have notice of and to have consented to this provision of our by-laws.Bylaws. This choice-of-forum provision may limit our stockholders'stockholders’ ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits. Alternatively, if a court were to find this provision of our amended and restated by-laws inapplicable or unenforceable with respect to one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such matters in other jurisdictions, which could adversely affect our business and financial condition.

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We may issue additional classes of preferred stock in the future, and the terms of the preferred stock may reduce the value of our common stock.

We are authorized to issue shares of preferred stock in one or more series. In the past, we have issued shares of preferred stock, including shares of our Preferred Stock issued in 2021. Our board of directorsBoard may determine the terms of future preferred stock offerings without further action by our stockholders. If we issue preferred stock, it could affect your rights or reduce the value of our outstanding common stock. In particular, specific rights granted to future holders of preferred stock may include voting rights, preferences as to dividends and liquidation, conversion and redemption rights, sinking fund provisions, and restrictions on our ability to merge with or sell our assets to a third party.


We do not expect to pay any cash dividends on our common stock.

We have not declared or paid any cash dividends on our common stock or other securities, and we currently do not anticipate paying any cash dividends in the foreseeable future. Because we do not anticipate paying cash dividends for the foreseeable future, our stockholders will not realize a return on their investment in our common stock except to the extent of any appreciation in the value of our common stock. Our common stock may not appreciate in value, or it may decline in value.

Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

Under Section 382 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change,” the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes (such as research and development tax credits) to offset its post-change income and taxes may be limited. In general, an “ownership change” occurs if there is a cumulative change in our ownership by “5% shareholders” that exceeds 50 percentage points over a rolling three-year period. Similar rules may apply under state tax laws. As a result of a previous ownership change, our annual utilization of approximately $59.3 million in federal net operating loss carryforwards became substantially limited. If we experience ownership changes as a result of future transactions in our stock, we may be further limited in our ability to use our net operating loss carryforwards and other tax assets to reduce taxes owed on the net taxable income that we earn. Any such limitations on the ability to use our net operating loss carryforwards and other tax assets could potentially result in increased future tax liability to us on any net income that we may earn in the future.

Item 1B. UNRESOLVED STAFF COMMENTS

None.

Item 1C. CYBERSECURITY

Risk Management and Strategy

In an effort to protect our business against cybersecurity threats, we have implemented a cybersecurity risk management program that is integrated with our internal risk management processes and designed to identify and protect against cyber threats as well as to respond to and recover from cyber incidents, as applicable. Our cybersecurity risk management program is informed by industry standards, such as the National Institute of Standards and Technology (NIST) Cybersecurity Framework, and is supported by periodic internal and external information security assessments and testing.

We have also established incident response policies and procedures, overseen by our Chief Financial Officer, to review and classify cybersecurity incidents and to define roles and responsibilities for response and remediation in the event of a cyber incident.

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None.

In addition, we collaborate with third-party advisory firms to periodically review and evaluate our security measures, which informs our ongoing strategy and execution of our cybersecurity program. We also leverage third-party providers to augment our internal security resources, including to support our ongoing monitoring and threat detection capabilities. We have a process to evaluate certain critical third-party providers before engagement as well as periodically thereafter, which may include a review of available audit reports, security documentation, operating controls, and industry reputation, as well as contractual requirements, as appropriate.

We have not identified any cybersecurity incidents or threats that have materially affected us or are reasonably likely to materially affect us, including our business strategy, results of operations, or financial condition; however, like other companies in our industry, we and our third-party vendors have from time to time experienced threats and security incidents that could affect our information or systems. For more information, please see our Risk Factors.

Item 2. PROPERTIES

We lease our headquarters in Los Angeles, California. The lease covers approximately 5,7392,771 square feet of office and storage space and expires in February 2020.2024. We did not renew this lease. Our monthly rent is $20,396, which is subject to annual increases.  In addition to the monthly rent, we are responsible for paying our allocable portion of operating expenses.  We have an option to extend the term of the lease for a five-year period and a right of first offer during the extended lease term to lease any available space on the sixth floor of the premises, subject to the terms and conditions set forth in the lease agreement.$15,361. We also lease additional storage space for approximately 540 square feet. This lease expiresexpired in February 2020,2024, and requires us to make monthly payments of $1,257,$1,475. The Company has signed a renewal for an 18-month term, at the same monthly payment. In March 2022, we entered into a sub-lease for our office space that provides for a monthly rental income of $8,867, subject to an annual increases.

We lease laboratory spaceincrease of 3.5 percent. The sub-lease expires in Freiburg, Germany, covering approximately 752 square meters (8,094 square feet). Our monthly rent is €10,070 (approximately $11,143), which is subject to annual increases. The amended lease expires on September 30, 2018, and we have an option to extend the term of the lease for up to three additional three-year periods.
CytRx 2017 10-K Page #23#

February 2024.

Item 3. LEGAL PROCEEDINGS

We are occasionally involved in legal proceedings and other matters arising from the normal course of business. As previously reportedOn November 30, 2022, Jerald Hammann (“Hammann”) filed a complaint (the “Complaint”) against the Company, Mr. Caloz, and Mr. Kriegsman (together, “Defendants”) in our Quarterly Report filed with the SEC on November 7, 2017, the following actions are currently outstanding:

Shareholder Derivative Actions in Delaware.  There are two competing derivative complaints pending in the Delaware Court of Chancery alleging claims related to our alleged retention of DreamTeamGroup and MissionIR.  On December 14, 2015, a shareholder derivative complaint, captioned Niedermeyer et al. v. Kriegsman et al., C.A. No. 11800, was filed against certain of our officers and directors, for which a second amended complaint was filed on October 12, 2016.  On September 6, 2016, one of the plaintiffs in the California litigation (discussed above) effectively refiled his complaint in the Delaware Court of Chancery, with the case captioned Taylor v. Kriegsman, C.A. No. 12720.   Following competing motions for appointment of a lead plaintiff and lead counsel, On February 22, 2017, the Court of Chancery appointed Niedermeyer et al.as lead plaintiffs inof the complaint. On May 3, 2017, the parties entered into negotiations with a mediator and on June 2, 2017, the parties entered into a MemorandumState of Understanding ("MOU") to settle the entire action. On June 15, 2017, the MOU was submitted to the Court and the parties are now seeking Court approval. The Stipulation of Settlement was filed with the Court on January 22, 2018, which was preliminarily approved by the Court.  A final approval hearing is scheduled for April 19, 2018.  Any petition for an attorney fee award to the Plaintiff's counsel will also be considered by the Court at the April 19, 2018 hearing.
Class Action in California.  On July 25 and 29, 2016, nearly identical class action complaints were filed in the U.S. District Court for the Central District of California, titled Crihfield v. CytRx Corp., et al., Case No. 2:16-cv-05519 and Dorce v. CytRx Corp., Case No. 2:16-cv-05666Delaware, alleging that we and certain of our officers violated the Securities Exchange Act of 1934 by allegedly making materially false and/or misleading statements, and/or failing to disclose material adverse facts to the effect that the clinical hold placed on the Phase 3 trial of aldoxorubicin for STS would prevent sufficient follow-up for patients involved in the study, thus requiring further analysis, which could cause the trial's results and/or FDA approval to be materially adversely affected or delayed.  The plaintiffs allege that such wrongful acts and omissions caused significant losses and damages to a class of persons and entities that acquired our securities between November 18, 2014 and July 11, 2016, and seek an award of compensatory damages, costs and expenses, including counsel and expert fees, and such other and further relief as the Court may deem just and proper. On October 26, 2016, the Court entered an Order consolidating the actions titled In re: CytRx Corporation Securities Litigation, Master File No. 16 cv-05519-SJO and appointing a Lead Plaintiff and Lead Counsel. Following the filingvarious violations of a first amended complaint on January 13, 2017, on March 14, 2017Cooperation Agreement, dated August 21, 2020, by and between the Company and Hammann. The Complaint alleges breaches of a provision limiting the individual defendants filedBoard’s ability to effect discretionary compensation and a Motion to Dismiss.  Plaintiff filed an Opposition thereto on April 28, 2017.non-disparagement provision. The Company and the individual defendants filedComplaint further alleges a Reply on May 30, 2017 and the matter was heard by the Court on June 12, 2017. On June 14, 2017, the Court issued an Order granting the Motion to Dismiss with leave to amend. Plaintiff filed a Second Amended Complaint and the Individual Defendants filed a renewed Motion to Dismiss. Plaintiff filed an Opposition thereto on July 24, 2017. The Company and the Individual Defendants filed a Reply on July 31, 2017. On August 14, 2017, the Court issued an Order granting in part and denying in part the motion to dismiss. On September 18, 2017, the Court issued an Order setting a schedule for the case.  On January 30, 2018, the parties entered into negotiations with a mediator and on February 1, 2018, the parties entered into a confidential Term Sheet to settle the Class Action. On February 7, 2018, the Court stayed the action for all purposes until May 2, 2018, to provide the parties sufficient time to prepare and submit a stipulation of settlement.
Shareholder Derivative Action in Delaware (Zyontz). On October 17, 2017, a shareholder derivative complaint was filed against certain current and former directors in the Delaware Court of Chancery, entitled Zyontz v. Kriegsman et al., Case No. 2017-0738-JRS. The complaint essentially sets forth the allegations pled in the federal securities class action in California, asserts a claim for breach of fiduciary duty, and seeks damages, fees and costs, and other and further relief as the Court may deem just and proper. On December 18, 2017,a purported implied obligation that the Company disclose various internal records to Hammann. Defendants believe the Complaint is wholly without merit and individual defendants filed motion to dismiss for failure to make a demand on the Board and for failure to state a claim, and a motion to stay the proceedings pending resolution of the federal securities class action.  On January 30, 2018, the parties participated in a mediation. The parties are currently negotiating a settlement agreement comprised of corporate governance reforms that will be submitted to the Court of Chancery for approval.
Shareholder Derivative Action in Delaware (Patterson). On September 1, 2017, a shareholder derivative complaint was filed against the current directors in the Delaware Court of Chancery, entitled Patterson v. Kriegsman et al., C.A. No. 2017-0636-TMR. The complaint sets forth claims for breach of fiduciary duty for allegedly disseminating false and misleading information, unjust enrichment, gross mismanagement, abuse of control and corporate waste based on allegations concerning various business decisions matters. The complaint seeks damages, corporate governance reforms, restitution, fees and costs, and other and further relief as the Court may deem just and proper. On September 26, 2017, the Company and individual defendants filed a motionhave moved to dismiss the complaint, for which the opening briefComplaint in support of such motion was filed on November 3, 2017, the plaintiff's opposition was filed on December 11, 2017, and the defendants' reply was filed on January 5, 2018. The hearing on the motionits entirety. Defendants intend to dismiss was heard by the Vice-Chancellor on March 8, 2018, and she took the matter under advisement. On March 13, 2018, the Vice-Chancellor ruled that defendants' motion to dismiss was granted, with prejudice.
litigate vigorously against Hammann’s claims.

We intend to vigorously defend against the foregoing complaints.any complaint. We have directors'directors’ and officers'officers’ liability insurance, which will be utilized, after the deductible, in the defense of these matters. The liability insurance may not cover all of the future liabilities we may incur in connection with the foregoing matters. These claims are subject to inherent uncertainties, and management's view of these matters may change in the future.

any matter involving our directors or officers.

We evaluate developments in legal proceedings and other matters on a quarterly basis. If an unfavorable outcome becomes probable and reasonably estimable, we could incur charges that could have a material adverse impact on our financial condition and results of operations for the period in which the outcome becomes probable and reasonably estimable.

CytRx 2017 10-K Page #24#



Item 4. MINE SAFETY DISCLOSURES

Not applicable.

42
Not Applicable.
CytRx 2017 10-K Page #25#


PART II

Item 5. MARKET FOR REGISTRANT'SREGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

Market Information

Our common stock is traded on The NASDAQ Capitalthe OTC Market under the symbol "CYTR."“LADX.” The following table sets forth the high and low sale prices for our common stock for the periods indicated as reported by the OTC Market. The NASDAQ Capital Market:

  High  Low 
Fiscal Year 2017:      
Fourth Quarter $2.94  $1.65 
Third Quarter $6.00  $2.40 
Second Quarter $5.94  $2.52 
First Quarter $3.06  $2.28 
         
Fiscal Year 2016:        
Fourth Quarter $4.44  $2.16 
Third Quarter $16.02  $3.30 
Second Quarter $21.96  $12.78 
First Quarter $18.48  $9.30 
         
high and low prices reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not necessarily represent actual transactions. The stock prices take into account the Reverse Stock Split effectuated in May 2023.

  High  Low 
Fiscal Year 2023:        
Fourth Quarter $1.95  $0.63 
Third Quarter $3.83  $1.49 
Second Quarter $12.00  $2.30 
First Quarter $15.00  $7.00 
         
Fiscal Year 2022        
Fourth Quarter $83.00  $45.00 
Third Quarter $100.00  $54.00 
Second Quarter $321.00  $89.00 
First Quarter $83.00  $45.00 

Holders

On March 16, 2018,28, 2024, there were approximately 350180 holders of record of our common stock. The number of record holders does not reflect the number of beneficial owners of our common stock for whom shares are held by brokerage firms and other nominees.

Dividends

We have not paid any cash dividends since our inception and do not contemplate paying any cash dividends in the foreseeable future.

Equity Compensation Plans

The following table sets forth certain information as of December 31, 2017,2023, regarding securities authorized for issuance under our equity compensation plans:

 
 
 
Plan Category
 
(a)
 
Number of Securities to be Issued Upon Exercise of Outstanding Options, Warrants and Rights
  
(b)
 
Number of Issued Shares of Restricted Stock
  
(c)
 
Weighted-Average Exercise Price of Outstanding Options, Restricted Stock, Warrants and Rights
  
Number of Securities Remaining Available for issuance Under Equity Compensation Plans (Excluding Securities Reflected in Columns (a) and (b)
 
Equity compensation plans approved by our security holders:            
      2000 Long-Term Incentive Plan  44,371     $34.56    
      2008 Stock Incentive Plan  2,821,141   775,194   8.82   1,247,662 
 
Equity compensation plans not approved by our security holders:
 
                
      Outstanding warrants (1)  3,980,781      4.26    
Total  6,846,293   775,194  $6.44   1,247,662 
______________

Plan Category 

(a)

Number of Securities to be Issued Upon Exercise of Outstanding Options, Warrants and Rights

  

(b)

Weighted-Average Exercise Price of Outstanding Options, Restricted Stock, Warrants and Rights

  Number of Securities Remaining Available for issuance Under Equity Compensation Plans (Excluding Securities Reflected in Column (a) 
Equity compensation plans approved by our security holders:         
2008 Stock Incentive Plan  10,350  $501.70    
Equity compensation plans not approved by our security holders:            
2019 Stock Incentive Plan  3,500  $549.00    
Outstanding warrants (1)  42  $3,360.00    
Total  14,042  $510.25    

(1) The warrants shown were issued in discrete transactions from time to time as compensation for services rendered by consultants, advisors or other third parties, and do not include warrants sold in capital-raising transactions. The material terms of such warrants were determined based upon arm's-lengtharm’s-length negotiations with the service providers. The warrant exercise prices approximateprice approximates the market price of our common stock at or about the date of grant, and the warrant terms range from two to ten years from the grant date.warrants expire in March 2024. The warrants contain customary anti-dilution adjustments in the event of a stock split, reverse stock split, reclassification or combination of our outstanding common stock and similar events and certain of the warrants contain anti-dilution adjustments triggered by other corporate events, such as dividends.

43
CytRx 2017 10-K Page #26#

Comparison of Cumulative Total Returns
The following line graph presentation compares cumulative total stockholder returns of CytRx with The NASDAQ

For more information on the 2008 Stock Market Index and The NASDAQ Pharmaceutical Index (the "Peer Index") for the five-year period from December 31, 2013 to December 31, 2017. The graph and table assume that $100 was invested in each of our common stock, The NASDAQ Stock Market IndexIncentive Plan and the Peer Index on December 31, 2012,2019 Stock Incentive Plan, see “Item 11. Executive Compensation—2008 Stock Incentive Plan and that all dividends were reinvested. This data was furnished by Zacks Investment Research.




  
December 31,
 
  
2013
  
2014
  
2015
  
2016
  
2017
 
CytRx Corporation  235.20   -56.29   -3.28   -85.97   -24.22 
The NASDAQ Stock Market Index  40.12   14.75   6.96   8.87   29.64 
The NASDAQ Pharmaceutical Index  64.86   30.51   5.82   -21.99   19.62 

the 2019 Plan Descriptions”.

Recent Issuances of Unregistered Securities

None.

There were no sales of unregistered securities during the year ended December 31, 2023.

Repurchase of Shares

We did not repurchase any of our shares during the year ended December 31, 2017.

CytRx 2017 10-K Page #27#

2023.

Item 6. SELECTED FINANCIAL DATA

General
The following selected financial data are derived from our audited financial statements. Our financial statements for these past five years have been audited by BDO USA, LLP, our independent registered public accounting firm. These historical results do not necessarily indicate future results. When you read this data, it is important that you also read our financial statements and related notes, as well as the "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Risk Factors" sections of this Annual Report. Financial information provided below has been rounded to the nearest thousand (except for per share data)[RESERVED].
  2017  2016  2015  2014  2013 
Statement of Operations Data:               
Revenue               
Licensing revenue $100,000  $200,000  $100,000  $100,000  $300,000 
Total revenue $100,000  $200,000  $100,000  $100,000  $300,000 
                     
Net loss $(34,986,000) $(50,771,000) $(58,587,000) $(30,118,000) $(47,485,000)
Basic and diluted loss per share applicable to common stock $(1.46) $(3.78) $(5.82) $(3.30) $(8.64)
`                    
Balance Sheet Data:                    
Cash, cash equivalents and short-term investments $37,643,000  $56,959,000  $57,297,000  $77,840,000  $38,568,000 
Total assets $48,348,000  $62,770,000  $67,024,000  $85,693,000  $41,500,000 
Total stockholders' equity $18,145,000  $24,777,000  $44,079,000  $67,911,000  $10,661,000 
                     
Factors Affecting Comparability
In July 2017, we issued 1,969,697 shares of our common stock as part of an exclusive licensing agreement granted to NantCell, Inc.
In May 2017, we completed a public offering of 5.0 million shares of our common stock. Net of underwriting discounts, legal, accounting and other offering expenses, we received proceeds of approximately $14.0 million.
In December 2016, we completed a public offering of 1.9 million shares of our common stock and 550 shares of our Series B Convertible Preferred Stock and re-priced outstanding July 2016 warrants to purchase 3.2 million shares of our common stock and extended the term of the warrants to July 2018.  Net of underwriting discounts, legal, accounting and other offering expenses, we received proceeds of approximately $7.5 million.
In July 2016, we completed a public offering issuing 4.8 million shares of our common stock and one-year warrants to purchase an equal number of shares of our common stock in a public offering. Net of underwriting discounts, legal, accounting and other offering expenses, the Company received proceeds of approximately $18.3 million
    In July 2015, we completed a $28.7 million underwritten public offering, in which we sold and issued approximately 1.8 million shares of common stock at a price of $16.50 per share. Net of underwriting discounts, legal, accounting and other offering expenses, the Company received proceeds of approximately $26.8 million.
In February 2014, we completed an $86.0 million underwritten public offering, in which we sold and issued 2.2 million shares of common stock at a price of $39.00 per share. Net of underwriting discounts, legal, accounting and other offering expenses, we received proceeds of approximately $80.5 million.
In October 2013, we completed a $25.9 million underwritten public offering, in which we sold and issued 1.9 million shares of common stock at a price of $13.50 per share. Net of underwriting discounts, legal, accounting and other offering expenses, we received proceeds of approximately $24.1 million.
CytRx 2017 10-K Page #28#

Item 7. MANAGEMENT'SMANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations should be read together with the discussion under "Selected“Selected Financial Data"Data” and our consolidated financial statements included in this Annual Report. This discussion contains forward-looking statements, based on current expectations and related to future events and our future financial performance, that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many important factors, including those set forth under the caption "Risk Factors"“Risk Factors” and elsewhere in this Annual Report.

Overview

CytRx

LadRx Corporation

We are is a biopharmaceutical research and development company specializing in oncology. OurThe Company’s focus is on the discovery, research and clinical development of novel anti-cancer drug candidates that employ novel linker technologies that target chemotherapeutic drugs to enhance the accumulationsolid tumors and release of cytotoxic anti-cancer agents at the tumor.  Since 2008, we have worked to develop aldoxorubicin, In Julyreduce off-target toxicities. During 2017, we entered into an exclusive worldwide license under which NantCell, Inc. took over development of aldoxorubicin, invested in our common stock and agreed to make future milestone and royalty payments upon the successful development and commercialization of aldoxorubicin. We are now actively pursuing new anti-cancer compounds through our drugLadRx’s discovery and research operation at our laboratory facilities in Freiburg, Germany.
LADR Drug Discovery Platform
The LADR™ (Linker Activated Drug Release) technology platform is a discovery engine combining our expertise in linker chemistry and albumin biology to create a pipeline of anti-cancer molecules that will avoid unacceptable systemic toxicity while delivering highly potent agents directly to the tumor. We have created a "toolbox" of linker technologies that have the ability to significantly increase the therapeutic index of ultra-high potency drugs (10-1,000 times more potent than traditional chemotherapies) by controlling the release of the drug payloads and improving drug-like properties. After infusion, these ultra-high potency drug conjugates bind to circulating albumin for transport of the drug to the tumor. Subsequently, due to specific conditions within the tumor, the linkers are cleaved and release the anti-cancer drug payload.

Our current efforts are focused on two classes of ultra-high potency drug conjugates.  Our strategy across these programs is to generate additional pre-clinical data that will allow them to make informed decisions regarding the selection of one or both programs for moving into human clinical trials either independently or on a partnered basis.

We recently entered into an agreement with Destum Partners, Inc., a leading strategic advisory firm serving companies in the life sciences industry, to assist in our pharma partnering activities.  Destum will be our exclusive advisor for the identification of partnership opportunities for LADR™ ultra-high potency drug conjugates.
During 2017, our discovery laboratoryGermany, synthesized and tested over 75 rationally designed drug conjugates with highly potent cytotoxicanti-cancer payloads, andculminating in the creation of two distinct classes of compounds have been created.  To date, fourcompounds. Four lead candidates have been(LADR 7 through LADR-10) were selected based on in vitro and animal preclinical studies in several different cancer models, stability, and manufacturing feasibility. Additional animal efficacyIn addition, a novel companion diagnostic, ACDx™, was developed to identify patients with cancer who are most likely to benefit from treatment with these drug candidates.

On June 1, 2018, the Company launched Centurion BioPharma Corporation (“Centurion”), a wholly-owned private subsidiary, and toxicology testingtransferred to Centurion all of these leadits assets, liabilities and personnel associated with the laboratory operations in Freiburg, Germany. In connection with said transfer, the Company and Centurion entered into a Management Services Agreement whereby the Company agreed to render advisory, consulting, financial and administrative services to Centurion, for which Centurion shall reimburse the Company for the cost of such services plus a 5% service charge. On December 21, 2018, LadRx announced that Centurion had concluded the pre-clinical phase of development for its four LADR™ (Linker Activated Drug Release) drug candidates, and for its albumin companion diagnostic (ACDx™). As a result of completing this work, operations taking place at the pre-clinical laboratory in Freiburg, Germany were no longer needed and, accordingly, the lab was closed at the end of January 2019.

On March 9, 2022, Centurion merged with and into LadRx, with LadRx absorbing all of Centurion’s assets and continuing after the merger as the surviving entity (the “Merger”). The Merger was implemented through an agreement and plan of merger pursuant to Section 253 of the General Corporation Law of the State of Delaware (the “DGCL”) and did not require approval from either our or Centurion’s stockholders. The Certificate of Ownership merging Centurion into LadRx was filed with the Secretary of State of Delaware on March 9, 2022.

44

Effective September 26, 2022, the Company changed its name from CytRx Corporation to LadRx Corporation pursuant to a Certificate of Amendment to our Restated Certificate of Incorporation (the “Certificate of Incorporation”) filed with the Secretary of State of Delaware. In accordance with the DGCL, its board of directors (the “Board”) approved the name change and the Certificate of Amendment. Pursuant to Section 242(b)(1) of the DGCL, stockholder approval was not required for the name change or the Certificate of Amendment.

2023 Reverse Stock Split

The Company effected a 1-for-100 reverse stock split (the “Reverse Stock Split”) of its issued and outstanding shares of common stock on May 17, 2023, pursuant to which every 100 shares of the Company’s issued and outstanding shares of common stock were converted into one share of common stock without any change in the par value per share. Any fraction of a share of common stock that would otherwise have resulted from the Reverse Stock Split were rounded up to the nearest whole share. All share and per share amounts in this Annual Report have been adjusted to reflect the reverse stock split as if it had occurred at the beginning of the earliest period presented.

Corporate Information

LadRx is underway.

CytRx 2017 10-K Page #29#


Aldoxorubicin
Until July 2017, we werea Delaware corporation, incorporated in 1985. Our corporate offices are located at 11726 San Vicente Boulevard, Suite 650, Los Angeles, California 90049, and our telephone number is (310) 826-5648. Our web site is located at www.ladrxcorp.com. We do not incorporate by reference into this Annual Report the information on, or accessible through, our website, and you should not consider it as part of this Annual Report.

LADR Drug Discovery Platform

The LADR™ Technology offers the opportunity for multiple pipeline drugs. The Company’s LADR™ technology platform consists of an organic backbone that is attached to a chemotoxic agent. The purpose of the LADR™ backbone is to first target and deliver the chemotoxic agent to the tumor environment, and then to release the chemotoxic agent within the tumor. By delivering, concentrating, and releasing the chemotoxic agent within the tumor, one expects to reduce the off-target side-effects of the chemotherapeutic, which in turn allows for several-fold higher dosing of the chemotherapeutic to the patient. Being small organic molecules, the Company expects LADR-based drugs to offer the benefits of targeting the tumor without the complexity, side effects, and expense inherent in macromolecules such as antibodies and nanoparticles.

The Company’s LADR-based drugs use circulating albumin as the binding target and as the trojan horse to deliver the LADR™ drugs to the tumor. Albumin is the most abundant protein in plasma and accumulates inside tumors due to the aberrant vascular structure that exists within solid tumors. Tumors use albumin as a nutritional source and for transport of signaling and other molecules that are important to the maintenance and growth of the tumor, which makes albumin an excellent target for drugs that are intended for solid tumors.

The Company’s LADR™ development efforts are focused on two classes of ultra-high potency albumin-binding drugs. These LADR-based drugs, LADRs 7, 8, 9, and 10, combine the researchproprietary LADR™ backbone with novel derivatives of the auristatin and maytansinoid drug classes. Auristatin and maytansinoid are highly potent chemotoxins, and require targeting to the tumor for safe administration to humans, as is the case for the U.S. Food and Drug Administration (“FDA”)-approved drugs Adcetris (auristatin antibody-drug-conjugate manufactured by Seagen, Inc.) and Kadcyla (maytansine antibody-drug-conjugate manufactured by Genentech, Inc.). We believe that LADR-based drugs offer the benefits of tumor targeting without the disadvantages of antibodies and other macromolecules, which include expense, complexity, and negative side effects. Additionally, albumin is a very well-characterized drug target, which we believe will reduce clinical and regulatory costs and risks.

The Company’s postulated mechanism of action for LADR-based drugs is as follows:

after administration, the linker portion of the drug conjugate forms a rapid and specific covalent bond to the cysteine-34 position of circulating albumin;

45

circulating albumin preferentially accumulates in tumors due to a mechanism called “enhanced permeability and retention”, which results in lower exposure to the drug in noncancerous tissues of the heart, liver, and other organs;
once localized at the tumor, the acid-sensitive linker of the LADR™ backbone is cleaved due to the specific conditions within the tumor and in the tumor microenvironment; and
free active drug is then released within the tumor, causing tumor cell death.

The first-generation LADR-based drug is called Aldoxorubicin. Aldoxorubicin is the well-known drug doxorubicin attached to the first generation LADR™ backbone (LADRs 7-10 employ a next generation LADR™ backbone). Aldoxorubicin has been administered to over 600 human subjects in human clinical trials and has proven the concept of LADR™ in that several-fold more doxorubicin can be safely administered to patients when the doxorubicin is attached to LADR™ than when administered as native doxorubicin. Aldoxorubicin has been licensed to ImmunityBio and is currently in a Phase II trial for pancreatic cancer.

The next generation LADR™ drugs are termed LADR 7, 8, 9, and 10. A great deal of Investigational New Drug (“IND”) enabling work has already been accomplished on LADR 7-10, including in-silico modeling, in-vitro efficacy testing in several different cancer models, in-vivo dosing, safety, and efficacy testing in several different cancer models in animals. We have also developed and proven manufacturability, an important step prior to beginning human clinical trials.

The IND-enabling work that remains prior to applying to the FDA for first-in-human studies for LADR 7-10 is limited due to the extensive experimentation already completed. For example, in the case of LADR 7, a manufacturing run under Good Manufacturing Practices (GMP) has been completed and the GMP LADR 7 currently in hand is sufficient to carry out final toxicology studies, and to initiate Phase IA studies in humans.

We expect the toxicology studies to be completed and the IND application for LADR 7 to be filed with the FDA by the end of the third quarter of 2024 or the beginning of the fourth quarter of 2024. Absent a clinical hold from the FDA, this timeline should allow the Company to be ready for first-patient dosing with LADR 7 by the end of 2024 (the period for the FDA review of an IND application is 30 days). If the Company encounters difficulties with the toxicology program or fails to meet the FDA’s requirements for the IND application, the first-patient dosing could be substantially delayed.

Because the LADR™ backbone in future products would be the same as the LADR™ backbone in current product candidates, (i.e. the chemotoxin can be changed without changing the LADR™ backbone), management anticipates that future product candidates beyond LADR 7-10 may enjoy abbreviated pre-clinical pathways to first-in-human. Such abbreviated pathways would be subject to FDA review and agreement.

The Company’s novel companion diagnostic, ACDx™ (albumin companion diagnostic) was developed to identify patients with cancer who are most likely to benefit from treatment with the four LADR™ lead assets. We have not yet determined whether the use of a companion diagnostic will be necessary or helpful, and plan to continue to investigate this question in parallel to the pre-clinical and clinical development of aldoxorubicin, our modified versionLADRs 7-10.

The LADR™ backbone and drugs that employ LADR™ are protected by domestic and international patents, and additional patents are pending.

46

Business Strategy for LADR™ Platform

With the non-dilutive financing concluded with XOMA (as defined below) in June 2023, the Company is now focused on preparing the work necessary to file an IND application with the FDA for LADR7. For example, the Company recently completed the production of approximately 100 grams of LADR7 under GMP, which is sufficient to carry out final toxicology studies, and to initiate Phase IA studies in human subjects.

The Company has also initiated the Good Laboratory Practices (“GLP”) toxicology program that is expected to form the foundation of the widely-used chemotherapeutic agent, doxorubicin. Aldoxorubicin combinesIND application for LADR 7 to the chemotherapeutic agent doxorubicinFDA. Management expects the toxicology studies to be completed and the IND application for LADR 7 to be filed with the FDA by the end of the third quarter of 2024 or the beginning of the fourth quarter of 2024. Absent a clinical hold from the FDA, this timeline should allow the Company to be ready for first-patient dosing with LADR 7 by the end of 2024 (the period for the FDA review of an IND application is 30 days). If the Company encounters difficulties with the toxicology program or fails to meet the FDA’s requirements for the IND, the first-patient dosing could be substantially delayed.

Management will continue to explore in parallel both partnered and non-partnered funding and development strategies for LADR™ with a novel linker-molecule that binds specificallygoal of obtaining the least costly capital possible to albumin in the blood to allow for deliveryenable value inflection milestones.

Partnering of higher amounts of doxorubicin (3½ to 4 times) without several of the major dose-limiting toxicities seen with administration of doxorubicin alone.


Aldoxorubicin

On July 27, 2017, wethe Company entered into an exclusive worldwide license (the “2017 License Agreement”) with ImmunityBio, Inc. (formerly known as NantCell, Inc. ("NantCell", and which merged with NantKwest Inc. in March 2021 (“ImmunityBio”)), granting to NantCellImmunityBio the exclusive rights to develop, manufacture and commercialize aldoxorubicin in all indications, and our company isindications. As a result, we are no longer directly working on the development of aldoxorubicin. As part of the license, NantCell2017 License Agreement, ImmunityBio made a strategic investment of $13 million in CytRxLadRx’s common stock at $6.60$660.00 per share (adjusted to reflect our 2017 reverse stock split)splits), a premium of 92% to the market price on that date. WeThe Company also issued NantCell a warrant to ImmunityBio to purchase up to 500,0005,000 shares of common stock at $6.60 over$660.00 per share, which such warrant expired on January 26, 2019.

ImmunityBio is conducting an open-label, randomized, Phase 2 study of a combination of immunotherapy, aldoxorubicin, and standard-of-care chemotherapy versus standard-of-care chemotherapy alone for the following 18 months. We are entitledtreatment of locally advanced or metastatic pancreatic cancer in patients who have had 1 or 2 lines of treatment (Cohorts A and B) or 3 or greater lines of treatment (cohort C). In June 2022, Immunity Bio presented data at the American Society of Clinical Oncology meeting showing that patients receiving combination immunotherapy with aldoxorubicin plus standard-of-care chemotherapy experienced overall survival of 5.8 months, compared to 3 months for historical control patients that had received only the standard-of-care chemotherapy (n=78, 95% confidence interval of 4 to 6.9 months). An additional 25 patients in the experimental group remain in the study. As of the date of this Annual Report, there have been no treatment-related deaths, and serious adverse events have been uncommon (6%).

Aldoxorubicin has received Orphan Drug Designation (“ODD”) by the FDA for the treatment of soft tissue sarcoma (“STS”). ODD provides several benefits including seven years of market exclusivity after approval, certain R&D related tax credits, and protocol assistance by the FDA. European regulators granted aldoxorubicin Orphan designation for STS which confers ten years of market exclusivity among other benefits.

Royalty Purchase Agreement with XOMA

On June 21, 2023, the Company, entered into (i) a Royalty Purchase Agreement (the “Royalty Agreement”) with XOMA (US) LLC (“XOMA”), for the sale, transfer, assignment and conveyance of the Company’s right, title and interest in and to certain royalty payments and milestone payments with respect to aldoxorubicin, and (ii) an Assignment and Assumption Agreement (the “Assignment Agreement”) with XOMA for the sale, transfer, assignment and conveyance of the Company’s right, title and interest in the Asset Purchase Agreement (the “2011 Arimoclomol Agreement”) between the Company and Orphazyme ApS (“Orphazyme”), dated as of May 13, 2011, and assigned to Zevra Denmark A/S (“Zevra Denmark”), effective as of June 1, 2022, which includes certain royalty and milestone payments with respect to arimoclomol. The combined aggregate purchase price paid to the Company for the sale, transfer, assignment and conveyance of the Company’s right, title and interest in and to aldoxorubicin and arimoclomol was $5 million, less certain transaction fees and expenses.

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The Royalty Agreement and the Assignment Agreement also provide for up to an additional $6 million based on regulatory and commercial milestones related to the development of arimoclomol and aldoxorubicin by their respective sponsors, Zevra, Inc. and Immunity Bio, Inc. The $6 million in potential post-closing payments is comprised of $1 million upon acceptance by the FDA of the arimoclomol New Drug Application (“NDA”), $1 million upon first commercial sale of arimoclomol, and $4 million upon FDA approval of aldoxorubicin. All royalty and milestone payments made to XOMA will be net of the existing licensing and milestone obligations owed by LadRx related to arimoclomol and aldoxorubicin.

Pursuant to the Royalty Agreement, the Company agreed to sell, transfer, assign and convey to XOMA, among other payments, all royalty payments and regulatory and commercial milestone payments payable to the Company pursuant to the worldwide license agreement, dated July 27, 2017, by and between the Company and Immunity Bio, Inc.. The Royalty Agreement also provides for the sharing of certain rights with XOMA to bring any action, demand, proceeding or claim as related to receiving such payments.

Management determined that the Royalty Agreement is not considered to be with a customer, and it does not fall within the scope of ASC 606. Instead, the Royalty Agreement represents an in-substance sale of nonfinancial assets, and, therefore, should be accounted for within the scope of ASC 610-20. As such, the Company recognized such net proceeds as other income in the accompanying statement of operations.

Transfer of Rights to Molecular Chaperone Assets (Orphayzme)

On May 13, 2011, pursuant to the Asset Purchase Agreement by and between the Company and Orphazyme A/S (“Orphazyme”, formerly Orphazyme ApS), LadRx sold the rights to arimoclomol and iroxanadine, based on molecular chaperone regulation technology, in exchange for a one-time, upfront payment and the right to receive up to an aggregatea total of $343$120 million in potential milestone payments contingent upon the achievement of certain pre-specified regulatory approvals and commercial milestones. We arebusiness milestones, as well as royalty payments based on a specified percentage of any net sales of products derived from arimoclomol (the “2011 Arimoclomol Agreement”). Orphazyme transferred its rights and obligations under the 2011 Arimoclomol Agreement to KemPharm Denmark A/S (“KemPharm”), a wholly owned subsidiary of KemPharm Inc., in May 2022.

In May 2021, Orphazyme announced that the pivotal phase 3 clinical trial for arimoclomol in Amyotrophic Lateral Sclerosis did not meet its primary and secondary endpoints, reducing the maximum amount that LadRx currently has the right to receive under the 2011 Arimoclomol Agreement to approximately $100 million. Orphazyme also tested arimoclomol in Niemann-Pick disease Type C (“NPC”) and Gaucher disease, and following a Phase II/III trial submitted to the FDA a New Drug Application for the treatment of NPC with arimoclomol. On June 18, 2021, Orphazyme announced it had received a complete response letter (the “Complete Response Letter”) from the FDA indicating the need for additional data. In late October 2021, Orphazyme announced it held a Type A meeting with the FDA, at which the FDA recommended that Orphazyme submit additional data, information and analyses to address certain topics in the Complete Response Letter and engage in further interactions with the FDA to identify a pathway to resubmission. The FDA concurred with Orphazyme’s proposal to remove the cognition domain from the NPC Clinical Severity Scale (“NPCCSS”) endpoint, with the result that the primary endpoint is permitted to be recalculated using the 4- domain NPCCSS, subject to the submission of additional requested information which Orphazyme had publicly indicated that it intended to provide. To bolster the confirmatory evidence already submitted, the FDA affirmed that it would require additional in vivo or pharmacodynamic (PD)/pharmacokinetic (PK) data.

48

Orphazyme had also submitted a Marketing Authorization Application (“MAA”) with the European Medicines Agency (the “EMA”). In February 2022, Orphazyme announced that although they had received positive feedback from the Committee for Medicinal Products for Human Use (“CHMP”) of the EMA, they were notified by the CHMP of a negative trend vote on the MAA for arimoclomol for NPC following an oral explanation.

On May 31, 2022, Orphazyme announced that it had completed the sale of substantially all of its assets and business activities for cash consideration of $12.8 million and assumption of liabilities estimated to equal approximately $5.2 million to KemPharm (the “KemPharm Transaction”). KemPharm is a specialty biopharmaceutical company focused on the discovery and development of novel treatments for rare CNS diseases. As part of the KemPharm Transaction, all of Orphazyme’s obligations to LadRx under the 2011 Arimoclomol Agreement, including with regard to milestone payments and royalties on sales, were assumed by KemPharm. KemPharm is expected to continue the early access programs with arimoclomol, and to continue to pursue the potential approval of arimoclomol as a treatment option for NPC. KemPharm resubmitted the NDA for arimoclomol in 2023. It is also identifying a regulatory path forward with the EMA. KemPharm re-branded to Zevra Therapeutics, Inc. in February 2023.

Assignment and Assumption Agreement with XOMA

On June 21, 2023, the Company entered into the Assignment Agreement with XOMA, pursuant to which, among others, the Company agreed to sell, transfer and assign to XOMA the Company’s right, title and interest in the arimoclomol pursuant to the 2011 Arimoclomol Agreement, including the right to receive certain milestone, royalty and other payments from Zevra.

Pursuant to the Assignment Agreement, the Company is entitled to receive ascending double-digit royalties(i) a one-time payment of $1 million upon acceptance of a re-submission of a New Drug Application to the FDA for net sales for soft tissue sarcomasarimoclomol, and mid(ii) a one-time payment of $1 million upon the first invoiced sale in certain territories of a pharmaceutical product derived from arimoclomol as an active pharmaceutical ingredient, subject to high single digit royalties for other indications.


In order to fund our business and operations, we have relied primarily upon sales of our equity securities, including proceeds from the exercise of stock options and common stock purchase warrants and we recently secured long-term financing. We also have received limited funding from our strategic partners and licensees.
At December 31, 2017, we had cash and cash equivalents of approximately $37.6 million. Under the termsreceipt of the loan agreement, however, we areapplicable regulatory approval required to maintain cash equal tosell such a minimum ofproduct in such countries. In January 2024, Zevra announced the greater of three months projected cash burn or $10 million. Management believes that its current resources will be sufficient to fund its operationsFDA had accepted the NDA for the foreseeable future. This estimate is based, in part, upon our currently projected expenditures for 2018arimoclomol and the first three monthsCompany received the one-time payment of 2019 of approximately $27.8$1 million (unaudited), which includes approximately $1.5 million (unaudited) for its clinical programs, approximately $3.1 million (unaudited) for pre-clinical development of new high potency cytotoxic albumin-binding cancer drugs, approximately $0.7 million (unaudited) for general operation of its clinical programs, approximately $10.1 million (unaudited) for other general and administrative expenses and $12.4 million of interest and principal payments on our outstanding term loan. These projected expenditures are also based upon numerous other assumptions and subject to many uncertainties, and actual expenditures may be significantly different from these projections. While these projections represent our current expected expenditures, we have the ability to reduce the amounts and alter the timing of research and development expenditures as needed to manage our liquidity needs while still advancing our research and development objectives. We will ultimately be required to obtain additional funding in order to execute our long-term business plans, although we do not currently have commitments from any third parties to provide us with long term debt or capital. We cannot assure that additional funding will be available on favorable terms, or at all. If we fail to obtain additional funding when needed, we may not be able to execute our business plans and our business may suffer, which would have a material adverse effect on our financial position, results of operations and cash flows.
February 2024.

Research and Development

Expenditures

In 2023, the Company spent $280,000 on expenditures for research and development activities related to continuing operationsoperations; there were $19.8 million, $35.9 million and $43.4 million, respectively,no such expenditures in 2022.

The Company is continuing to conduct activities with the goal of filing an IND application for LADR7 towards the years ended December 31, 2017, 2016 and 2015, or approximately 60%, 68% and 68%, respectively,end of our total expenses.

Research and development expenses are further discussed below under "Critical Accounting Policies and Estimates" and "Results of Operations."

Our currently projected expenditures for 2018 include approximately $1.5 million for our clinical programs for aldoxorubicin, approximately $3.1 million for pre-clinical development of new high potency cytotoxic albumin-binding cancer drugs, and approximately $0.7 million related to supporting our clinical programs. The actual cost of our clinical programs could differ significantly from our current projections due to any additional requirements or delays, or if actual costs are higher than current management estimates for other reasons. In the event that actual costs of our clinical programs, or any of our other ongoing research activities, are significantly higher than our current estimates, we may be required to significantly modify our planned level of operations.
2024.

All of our product candidates in development must be approved by the FDA or corresponding foreign governmental agencies before they can be marketed. The process for obtaining FDA and foreign government approvals is both time-consuming and costly, with no certainty of a successful outcome. A discussion of these and other risks and uncertainties associated with our business is set forth in the "Risk Factors"“Risk Factors” section of this Annual Report.

Research and Development Expenses

Research and development expenses consist of costs incurred for direct and overhead-related research expenses and are expensed as incurred. Costs to acquire technologies, including licenses, that are utilized in research and development and that have no alternative future use are expensed when incurred. Technology developed for use in our product candidates is expensed as incurred until technological feasibility has been established.

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CytRx 2017 10-K Page #30#

Critical Accounting Policies and Estimates

Management's

Management’s discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates, including those related to stock options, impairment of long-lived assets, including accrued liabilities and certain expenses. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.

Our significant accounting policies are summarized in Note 2 of the Notes to Consolidated Financial Statements included in this Annual Report. We believe the following critical accounting policies are affected by our more significant judgments and estimates used in the preparation of our consolidated financial statements:

Revenue Recognition
Revenue consists of license fees from strategic alliances with pharmaceutical companies, as well as service and grant revenues. Service revenue consists of contract research and laboratory consulting. Grant revenues consist of government and private grants.
Monies received for license fees are deferred and recognized ratably over the performance period in accordance with Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") ASC 605-25, Revenue Recognition – Multiple-element Arrangements ("ASC 605-25"). Milestone payments will be recognized upon achievement of the milestone as long as the milestone is deemed substantive and we have no other performance obligations related to the milestone and collectability is reasonably assured, which is generally upon receipt, or recognized upon termination of the agreement and all related obligations. Deferred revenue represents amounts received prior to revenue recognition.
Revenues from contract research, government grants, and consulting fees are recognized over the respective contract periods as the services are performed, provided there is persuasive evidence of an arrangement, the fee is fixed or determinable and collection of the related receivable is reasonably assured. Once all conditions of the grant are met and no contingencies remain outstanding, the revenue is recognized as grant fee revenue and an earned but unbilled revenue receivable is recorded.
Research and Development Expenses
Research and development expenses consist of costs incurred for direct and overhead-related research expenses and are expensed as incurred. Costs to acquire technologies, including licenses, that are utilized in research and development and that have no alternative future use are expensed when incurred. Technology developed for use in our product candidates is expensed as incurred until technological feasibility has been established.

Clinical Trial Expenses

Clinical trial expenses, which are included in research and development expenses, include obligations resulting from our contracts with various contract research organizations or CROs,(“CROs”), in connection with conducting clinical trials of our product candidates. We recognize expenses for these activities based on a variety of factors, including actual and estimated labor hours, clinical site initiation activities, patient enrollment rates, estimates of external costs and other activity-based factors. We believe that this method is the best measure of the efforts expended on a clinical trial with the expenses we record. We adjust our rate of clinical expense recognition if actual results differ from our estimates. If our estimates prove to be incorrect, clinical trial expenses recorded in any particular period could vary.

CytRx 2017 10-K Page #31#

Stock-based Compensation

Our stock-based employee compensation plans are described in Note 13

The fair value of the Notes to Financial Statements. We follow the provisions of ASC 718, Compensation - Stock Compensation ("ASC 718"), which requires the measurementCompany’s stock option and recognition of compensation expense for all stock-based awards made to employees.

Forrestricted stock options and stock warrants paid in consideration of services rendered by non-employees, we recognize compensation expense in accordance with the requirements of ASC 505-50, Equity-Based Payments to Non-Employees ("ASC 505-50").
Non-employee option grants that do not vest immediately upon grant are recorded as an expense over the vesting period. At the end of each financial reporting period prior to performance, the value of these options, as calculatedis estimated using the Black-Scholes option-pricingBlack-Scholes-Merton Option Pricing model, is determined, and compensation expense recognized or recovered during the period is adjusted accordingly. Since the fair market value of options grantedwhich uses certain assumptions related to non-employees is subject to change in the future, the amountrisk-free interest rates, expected volatility, expected life of the future compensation expense is subject to adjustment until the common stock options or warrants are fully vested.
restricted stock, and future dividends. Compensation expense is recorded based upon the value derived from the Black-Scholes-Merton Option Pricing model and based on actual experience. The assumptions used in the Black-Scholes-Merton Option Pricing model could materially affect compensation expense recorded in future periods.

Basic and Diluted Net LossIncome (Loss) Per Share

of Common Stock

Basic and diluted net lossincome (loss) per share of common share attributable to common shareholdersstock is computed usingbased on the weighted-average number of shares of common sharesstock outstanding. for the period. Diluted net lossincome (loss) per common share is computed by dividing the net income (loss) applicable to common stockholders by the weighted average number of shares of common stock outstanding plus the number of additional shares of common stock that would have been outstanding if all dilutive potential common stock had been issued using the weighted-average numbertreasury stock method. Potential shares of common sharesstock are excluded from the computation when their effect is antidilutive. Common stock equivalents that could potentially dilute net income (loss) per share in the future, and common share equivalents outstanding. Potentially dilutive stock options and warrants to purchase approximately 7.6 million, 8.3 million and 3.6 million shares at December 31, 2017, 2016 and 2015, respectively,which were excluded from the computation of diluted net lossincome (loss) per share, because the effect would be anti-dilutive.were as follows:

  As of December 31, 
  2023  2022 
       
Options to acquire common stock  14,000   17,651 
Warrants to acquire common stock  42   42 
Convertible preferred stock     31,277 
Preferred Investment option     113,637 
   14,042   162,607 

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Potential Strategic Alternatives
From time to time, we may consider strategic alternatives available to us to enhance shareholder value. Strategic alternatives could include the acquisition of or strategic partnership with one or more parties or the licensing of some of our proprietary technologies. See "Item 1A – Risk Factors – The impact and results of our exploration of strategic alternatives are uncertain and may not be successful."

Liquidity and Capital Resources

General

Going Concern

The Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. During the year ended December 31, 2023, although we realized a net income of $0.4 million, we had a loss from operations of $3.8 million, and incurred a net loss of $4.2 million for the year ended December 31, 2022, and had total stockholders’ equity as of December 31, 2023 of $0.1 million. The Company has no recurring revenue, and we are likely to continue to incur losses unless and until we conclude a successful strategic partnership or financing for our LADR™ technology. As a result, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern. The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

In order to fund our business and operations, we have relied primarily upon sales of our equity securities, including proceeds from the exercise of stock options and common stock purchase warrants and a long-term loan financing completed in February 2016.financing. We also have received limited funding from our strategic partners and licensees. At December 31, 2017, we had cash and cash equivalents of approximately $37.6 million. Under the terms of the loan agreement, however, we are required to maintain cash equal to a minimum of the greater of three months projected cash burn or $10 million. Management believes that its current resources will be sufficient to fund its operations for the foreseeable future. This estimate is based, in part, upon our currently projected expenditures for 2018 and the first three months of 2019 of approximately $27.8 million (unaudited), which includes approximately $1.5 million (unaudited) for its clinical programs, approximately $3.1 million (unaudited) for pre-clinical development of new high potency cytotoxic albumin-binding cancer drugs, approximately $0.7 million (unaudited) for general operation of its clinical programs, approximately $10.1 million (unaudited) for other general and administrative expenses and $12.4 million of interest and principal payments on our outstanding Term Loans (defined below). These projected expenditures are also based upon numerous other assumptions and subject to many uncertainties, and actual expenditures may be significantly different from these projections. While these projections represent our current expected expenditures, we have the ability to reduce the amounts and alter the timing of research and development expenditures as needed to manage our liquidity needs while still advancing our research and development objectives. We will ultimately be required to obtain additional funding in order to execute our long-term business plans, although we do not currently have commitments from any third parties to provide us with long termlong-term debt or capital. We cannot assure that additional funding will be available on favorable terms, or at all. If we fail to obtain additional funding when needed, we may not be able to execute our business plans and our business may suffer, which would have a material adverse effect on our financial position, results of operations and cash flows.

If NantCell obtains marketing approval We have approximately $1.0 million of contractual obligations in 2024 and successfully commercializes aldoxorubicin, we anticipate it will take two years, and possibly longer, for usexpect to generate significant recurring revenue, and we will be dependent on future financing until such time, if ever, as we can generate significant recurring revenue. pay these out of the Company’s balance sheet cash. We have a total of approximately $1.0 million in material contractual obligations beyond 2024.

We have no commitments from third parties to provide us with any additional financing, and we may not be able to obtain future financing on favorable terms, or at all. Failure to obtain adequate financing would adversely affect our ability to operate as a going concern. If we raise additional funds by issuing equity securities, dilution to stockholders may result and new investors could have rights superior to holderssome or all of the shares issued in this offering.our existing equity holders. In addition, debt financing, if available, may include restrictive covenants. If adequate funds are not available to us, we may have to liquidate some or all of our assets or to delay or reduce the scope of or eliminate some portion or all of our development programs or clinical trials. We also may have to license to other companies our product candidates or technologies that we would prefer to develop and commercialize ourselves.

CytRx 2017 10-K Page #32#

Effective November 1, 2017, we completed a 1-for-6 reverse stock split of our outstanding shares of common and preferred stock, reduced our authorized shares of both common and preferred stock by one-sixth; no change was made to the per-share par value of the common stock. All share and per share amounts in the accompanying financial statements have been adjusted to reflect the reverse stock split as if it had occurred at the beginning of the earliest period presented.

Discussion of Operating, Investing and Financing Activities

Cash Flows from Operating Activities

Net loss for the year ended December 31, 2017 was $35.0 million, and cash used forprovided in operating activities for that period was $27.2 million. The net loss reflects $3.3 million of stock option and warrant expense, interest expense on the Term Loan of $3.8 million and a non-cash gain of $1.4 million on the fair value adjustment of the warrant liability.

Net loss for the year ended December 31, 2016 was $50.8 million, and cash used for operating activities for that period was $49.9 million. The net loss reflects $6.7 million of stock option and warrant expense, interest expense on the Term Loan of $2.8 million and a non-cash gain of $3.8 million on the fair value adjustment of the warrant liability.
Net loss for the year ended December 31, 2015 was $58.6 million, and cash used for operating activities for that period was $47.6 million. The net loss reflects $7.4 million of stock option and warrant expense, and a non-cash gain of $4.4 million on the fair value adjustment of the warrant liability.
For the year ended December 31, 2017, no money was provided by investing activities, and $0.1 million was used for the purchase of equipment and furnishings.
For the year ended December 31, 2016, $34.0 million was provided by investing activities. This included $35.0 million of net proceeds from the sale of short-term investments partially offset by the purchase of equipment and furnishings of $1.0 million, primarily for our laboratory in Freiburg, Germany.
For the year ended December 31, 2015, $10.3 million was provided by investing activities. This included $10.6 million net proceeds from the sale of short-term investments and the difference for purchase of equipment and furnishings, primarily for our laboratory in Freiburg, Germany.

Cash provided by financing activities for the year ended December 31, 20172023 was $8.0$1.0 million, which included $14.0 millionwas primarily the result of net proceeds received from our May 2017 public offering. We also received $6.1 million from the sale of common sharesroyalty and warrantsmilestone rights, net of transaction costs of $4.2 million less a net loss from operations of $3.8 million, plus $0.6 million in net cash outflows associated with changes in assets and liabilities. The net cash outflows associated with changes in assets and liabilities were primarily due to NantCell, Inc. We also received net proceedsreductions of $3.2$0.4 million from the exercise of stock optionsprepaid expenses and warrants and made principal Term Loan payments$0.2 million in amortization of $15.0right-of-use assets, an increase of $0.2 million in accounts payable, offset by a decrease in lease liabilities of $0.2 million.
Cash provided by financing

Net cash used in operating activities for the year ended December 31, 20162022 was $50.5$4.8 million, which included $25.8was primarily the result of a net loss from operations of $4.2 million, plus $0.6 million in net cash outflows associated with changes in assets and liabilities. The net cash outflows associated with changes in assets and liabilities were primarily due to reductions of $1.0 million of net proceeds received from our Decemberaccrued expenses, $0.5 million in accounts payable and July 2016 public offerings.  We also received net proceeds$0.2 million in lease liabilities, offset by an increase in prepaid expenses and other current assets of $24.0 million from our Term Loans in February 2016 and $0.7 million, $0.2 million in insurance receivable and $0.2 million in amortization of right-of-use assets.

Cash Flows from Investing Activities

We purchased minimal fixed assets in both the exerciseyears ended December 31, 2023 and December 31, 2022 and do not expect any significant capital spending during the next 12 months.

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Cash Flows from Financing Activities

We purchased the preferred investment options for $250,000 and paid dividends of stock options and warrants.

Cash provided by financing activities for$69,000 on the shares of Series C Preferred Stock in the year ended December 31, 2015 was $27.42023.

We paid dividends of $0.6 million which included $26.8 millionon the shares of net proceeds received from our July 2015 public offering.

Term Loan Facility
On February 5, 2016, we entered into a loan and security agreement with Hercules Technology Growth Capital, Inc. ("HTGC"), as administrative agent and lender, and Hercules Technology III, L.P., as lender ("Hercules"), pursuant to which the lenders made term loans to us on February 8, 2016Series C Preferred Stock in the aggregate principal amountyear ended December 31, 2022.

We continue to evaluate potential future sources of $25 million (the "Term Loans").  The Term Loans bear interest at the daily variable rate per annum equal to 6.0% plus the prime rate, or 10.5%, whichever is greater. We are required to make interest-only payments on the Term Loans through February 28, 2017, and beginning on March 1, 2017 blended equal monthly installments of principal amortization and accrued interest until the maturity date of the Term Loans on February 1, 2020. Under the terms of the loan, we are required to maintain a minimum cash balance equal to the greater of (i) $10 million or (ii) forward three months projected cash burn. As security under our obligations, we issued to the lenders warrants to purchase a total of 105,691 shares of our common stock at an exercise price of $12.30. These warrants are classifiedcapital, as equity warrants with a fair value of $633,749. All outstanding principal and accrued interest on the term loans will be due and payable in full on the maturity date of February 1, 2020.

CytRx 2017 10-K Page #33#


On July 28, 2017, we entered into an Amended Loan Services Agreement with the lenders of the Term Loans whereby we agreed to make an immediate payment of $5 million of principal and unpaid interest, a further $5 million payment of principal and unpaid interest by September 30, 2017, and agreed to an updated schedule of monthly payments and a new maturity date of August 1, 2018.

On July 28, 2017, we entered into a First Amendment to Loan and Security Agreement providing for our payment, on July 28, 2017, of $5.0 million in outstanding principal and unpaid interest due under the Loan Agreement, and for our potential repayment, on or prior to September 30, 2017, of an additional $5.0 million outstanding principal under the Loan Agreement. We made the First Repayment on July 28, 2017.  Pursuant to the Amendment, the lenders consented to the License Transaction with NantCell and agreed that the License Transaction is deemed a "Permitted Transfer" under the Loan Agreement, and confirmed that the sale of our common stock to NantCell is not an "Equity Event" under the Loan Agreement.

      In connection with the Loan Agreement, we restructured the existing lender warrants to purchase an aggregate of up to approximately 105,691 shares of our common stock at an exercise price of $12.30 per share. Pursuant to the Amendment, a portion of the warrants (representing 80% of the total number of shares issuable upon exercise of the warrants) was amended to change the exercise price of such portion of the warrants from $12.30 per share to the 30-day volume-weighted average price of our common stock over the 30-day period beginning 15 days before the July 28, 2017 announcement of the License Transaction (the "Warrant Amendments").

Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements that have a material current effect or that are reasonably likely to have a material future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources.

Contractual Obligations
We acquire assets still in development and enter into research and development arrangements with third parties that often require milestone and royalty payments to the third-party contingent upon the occurrence of certain future events linked to the success of the asset in development. Milestone payments may be required, contingent upon the successful achievement of an important point in the development life-cycle of the pharmaceutical product (e.g., approval of the product for marketing by a regulatory agency). We also typically have to make royalty payments based upon a percentage of the sales of the pharmaceutical product in the event that regulatory approval for marketing is obtained. Because of the contingent nature of these payments, they are not included in the table of contractual obligations.
These arrangements may be material individually, and in the event that multiple milestones are reached in the same period, the aggregate charge to expense could be material to the results of operations in any one period. In addition, these arrangements often give us the discretion to unilaterally terminate development of the product, which would allow us to avoid making the contingent payments; however, we are unlikely to cease development if the compound successfully achieves clinical testing objectives.
Our current contractual obligations that will require future cash payments are as follows (in thousands):
  Payments due by periods as of December 31, 2017 
Contractual Obligations Total  Year 1  Years 2 and 3  Years 4 and 5  Years 6 and beyond 
Operating lease obligations $710  $373  $337  $  $ 
  Employment obligations  4,848   1,678   2,113   1,057    
  Term loan obligation  12,377   12,377          
  R&D contract obligations  1,000   1,000          
   Total contractual obligations $18,935  $15,428  $2,450  $1,057  $ 
(1)
Operating leases are primarily our facility lease obligations, as well as equipment and software lease obligations with third party vendors.
(2)
Employment agreements include management contracts that provide for minimum salary levels, adjusted periodically at the discretion of our Compensation Committee, as well as minimum bonuses and
employee benefits, in some cases.
(3)Term loan obligation includes principal and interest payments and an end fee payment.
(4)Research and development obligations relate primarily to our Reimbursement Agreement with NantCell, Inc.

 We apply the disclosure provisions of ASC 460, Guarantees ("ASC 460"), to our contractual guarantees and indemnities. We have provided contractual indemnities to other parties against possible losses suffered or incurred by the indemnified parties in connection with various types of third-party claims, as well as indemnities to our officers and directors against third party claims arising from the services they provide to us. To date, we have not incurred material costs as a result of these indemnities, and we do not expectcurrently have commitments from any third parties to incur material costs in the future; further,provide us with additional capital and we maintain insurancemay not be able to cover certain losses arising from these indemnities. Accordingly, we have not accrued any liabilities related to these indemnities.
CytRx 2017 10-K Page #34#

Net Operating Loss Carryforwards
At December 31, 2017, we had federal and state net operating loss carryforwardsobtain future financing on favorable terms, or at all. The results of $373.7 million and $236.3 million, respectively, available to offset against future taxable income, which expire in 2018 through 2037.
As a result of a change in-control that occurred in the CytRx shareholder base in 2013, approximately $136.8 million in federal net operating loss carryforwards became substantially limited in their annual availability. We currently believe that the remaining $236.9 million in federal net operating loss carryforwards,our technology licensing efforts and the $236.3 million in state net operating loss carryforwards,actual proceeds of any fund-raising activities will determine our ongoing ability to operate as a going concern. Our ability to obtain future financings through joint ventures, product licensing arrangements, royalty sales, equity financings, grants or otherwise is subject to market conditions and our ability to identify parties that are unrestricted.
Aswilling and able to enter into such arrangements on terms that are satisfactory to us. Depending upon the outcome of December 31, 2017,our fundraising efforts, the accompanying financial information may not necessarily be indicative of our future financial condition. Failure to obtain adequate financing would adversely affect our ability to operate as a going concern.

There can be no assurance that we also had researchwill be able to generate revenues from our product candidates and development tax credits for federal and state purposes of approximately $16.6 million and $21.9 million, respectively, available for offset against future income taxes, which expire in 2022 through 2037. Based on an assessment of all available evidence including, but not limited to, our limited operating history in its core business and lack of profitability, uncertainties of the commercial viability of its technology, the impact of government regulation and healthcare reform initiatives, and other risks normally associated with biotechnology companies,become profitable. Even if we have concluded that it is more likely than not that these net operating loss carryforwards and credits willbecome profitable, we may not be realized and, as a result, a 100% deferred tax valuation allowance has been recorded against these assets.

able to sustain that profitability.

We do not have any off-balance sheet arrangements.

Results of Operations

We incurred a net lossincome (loss) of $35.0 million, $50.8$0.4 million and $58.6($4.2) million for the years ended December 31, 2017, 20162023 and 2015,2022, respectively.

During 2017, 2016the years ended December 31, 2023 and 2015,2022, we recognized no service revenue and earned an immaterial amount of license fees and grant revenue. AllWe will no longer be entitled to future licensing fees underrevenues from our current licensing agreements, are dependent upon successful development milestones being achieved by our licensees.  In 2017,since we recognized deferred revenue of $6.9 million fromtransferred the exclusive licensing agreement signedroyalty and milestone rights associated with NantCell, Inc.  We anticipate recognizing that revenue in 2018.

Duearimoclomol and aldoxorubicin to XOMA, pursuant to the nature of research and development, our operating results may fluctuate from period to period,Royalty Agreement and the resultsAssignment Agreement for net proceeds of prior periods should not be relied uponapproximately $4.2 million, along with an aggregate of $6 million in potential post-closing payments, based on achievement of certain future milestones. We recognized the net proceeds in connection with the Royalty Agreement and the Assignment Agreement as predictiveOther Income on our consolidated statement of operations.

General and Administrative

  Year Ended December 31, 
  2023  2022 
  (In thousands) 
General and administrative expenses $3,532  $4,534 
Employee stock and stock option expense     11 
Total $3,532  $4,545 

General and administrative expenses include all administrative salaries and general corporate expenses, including legal expenses associated with the resultsprosecution of our intellectual property. Our general and administrative expenses, excluding employee stock and stock option exercises, were $3.5 million and $4.5 million in future periods.

the years ended December 31, 2023 and 2022, respectively.

Research and Development

  Years Ended December 31, 
  2017  2016  2015 
  (In thousands) 
Research and development expenses $19,279  $34,107  $41,805 
Non-cash research and development expenses  12       
Employee stock and stock option expense  549   1,823   1,591 
Total $19,840  $35,930  $43,396 

Research expenses are expenses incurred by us in the discovery of new information that will assist us in the creation and the development of new drugs or treatments. Development expenses are expenses incurred by us in our efforts to commercialize the findings generated through our research efforts.

Research and development expenses

We incurred during 2017, 2016 and 2015 relate to our various development programs. In 2017, our$0.3 million in research and development expenses decreased substantially over 2016 since our pivotal, global Phase 3 clinical trial for STS with aldoxorubicin wound down in the year. These expenses included $11.7 million for our clinical programs for aldoxorubicin, $3.3 million for our drug discovery laboratory, and approximately $4.3 million for general operations of our clinical program, including licensing fees. In 2016, our research and development expenses decreased over 2015 primarily due to a reduction in costs for our pivotal, global Phase 3 clinical trial for STS with aldoxorubicin. The costs of our global Phase 2b clinical trial in SCLC remained consistent with the prior year. These expenses included approximately $27.1 million for our clinical programs for aldoxorubicin, approximately $2.3 million at our drug discovery laboratory, and approximately $4.3 million for general operation of our clinical programs. In 2015, research and development expenses totaled approximately $37.0 million for our clinical programs for aldoxorubicin, which included a full year of costs in our pivotal, global Phase trial, approximately $1.7 million at our drug discovery laboratory, and approximately $3.6 million for general operation of our clinical programs.

As compensation to consultants, or in connection with the acquisition of technology, we sometimes issue shares of common stock, stock options and warrants to purchase shares of common stock. For financial statement purposes, we value these shares of common stock, stock options, and warrants at the fair value of the common stock, stock options or warrants granted, or the services received, whichever is more reliably measurable. In 2017, we record $11,600 of non-cash expense,ended December 31, 2023, as compared to $0 in both 2016 and 2015.  In 2017, we recorded $0.5 million of employee stock and stock option expense, as compared to $1.8 million in 2016 and $1.6 million in 2015.
CytRx 2017 10-K Page #35#


General and Administrative

  Year Ended December 31, 
  2017  2016  2015 
  (In thousands) 
General and administrative expenses $9,718  $11,078  $13,871 
Stock, stock option and warrant expenses to non-employees and consultants  874   236   226 
Employee stock and stock option expense  1,910   4,677   5,568 
Total $12,502  $15,991  $19,665 

General and administrative expenses include all administrative salaries and general corporate expenses, including legal expenses associated with the prosecution of our intellectual property. Our general and administrative expenses, excluding common stock, stock options and warrants issued, were $9.7 million, $11.1 million and $13.9 million in 2017, 2016 and 2015, respectively. In 2017, the general and administrative expenses decreased by 12.3%, primarily due to a decrease in salaries, since 2016 included pre-commercialization activities in the first half of thecomparative 2022 year. In 2015, these expenses included litigation settlement expenses of $5.5 million (of which a non-cash amount of $4.5 million was settled through the issuance of our common shares).
From time to time, we issue shares of our common stock or warrants or options to purchase shares of our common stock to consultants and other service providers in exchange for services. For financial statement purposes, we value these shares of common stock, stock options, and warrants at the fair value of the common stock, stock options or warrants granted, or the services received whichever we can measure more reliably. In 2017, we recorded $0.9 million of such expenses, as compared to $0.2 million and $0.2 million in 2016 and 2015, respectively. We recorded employee stock option expense of $1.9 million, $4.7 million and $5.6 million in 2017, 2016 and 2015, respectively.

Depreciation and Amortization

Depreciation and amortization expenses for the years ended December 31, 2017, 20162023 and 20152022 were approximately $0.6 million, $0.5 million$12,000 and $0.3 million,$15,000, respectively. The depreciation expense reflects the depreciation of our equipment and furnishings.

52
Other Income (Expense)
We realized a small foreign exchange loss in 2017, other income of $0.2 million in 2016 from a VAT refund, and a de minimus amount of other income in 2015.

Interest Income

Interest income was $0.4 million$55,000 in 2017, $0.3 millionthe year ended December 31, 2023 and $12,000 in 2016 and $0.2 million in 2015.the year ended December 31, 2022. The variancesvariance between years areis attributable primarily to the amount of funds available for investment each year and, to a lesser extent, changes in prevailing market interest rates.

Interest Expense
On February 5, 2016, we entered into a loan

Known Trends, Events and security agreement with Hercules Technology Growth Capital, Inc. ("HTGC"), as administrative agent and lender, and Hercules Technology III, L.P., as lender. The lenders made term loans on February 8, 2016 inUncertainties

Not applicable

Recently Adopted Accounting Pronouncements

Recent authoritative guidance issued by the aggregate principal amount of $25 million, and at an interest rate of 9.5%. The interest rate is peggedFASB (including technical corrections to the Prime rateASC), the American Institute of Certified Public Accountants, and at December 31, 2017, the interest rate stood at 10.5%. Total interest expense in 2017 was $3.8 million, $2.8 million in 2016 and $0 in 2015.

CytRx 2017 10-K Page #36#

Recent Accounting Pronouncements
In January 2017, the FASB issued an ASU entitled "Intangibles - Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment." The objective of the ASU isSEC did not, or are not expected to, simplify how an entity is required to test goodwill for impairment by eliminating Step 2 from the goodwill impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit's goodwill with the carrying amount of that goodwill. This ASU is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted. We do not believe that the adoption of this guidance will have a material impact on our financial statements.


In August 2016, the Financial Accounting Standards Board issued ASU No. 2016-15 "Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (a consensus of the Emerging Issues Task Force)." The objective of ASU No. 2016-15 is to provide specific guidance on eight cash flow classification issues and how to reduce diversity in how certain cash receipts and cash payments are presented and classified in the statement of cash flows under Topic 230, Statement of Cash Flows, and other Topics. The amendments in this update are effective for public business entities for fiscal years beginning after December 15, 2017 and interim periods within those fiscal years. We are still in the process of determining the impact that the implementation of ASU 2016-15 will have on our financial statements.

In March 2016, the FASB issued Accounting Standards Update 2016-09, Compensation—Stock Compensation ("ASU 2016-09"). ASU 2016-09 includes several areas of simplification to stock compensation including simplifications to the accounting for income taxes, classification of excess tax benefits on the Statement of Cash Flows and forfeitures. ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016. We adopted this Standard on January 1, 2017. The adoption of this Standard did not have a material impact to our financial position or our results of operations.

 In February 2016, the FASB issued ASU No. 2016-02, "Leases (Topic 842)," which requires companies to recognize all leases as assets and liabilities on theCompany’s consolidated balance sheet. This ASU retains a distinction between finance leases and operating leases, and the classification criteria for distinguishing between finance leases and operating leases are substantially similar to the classification criteria for distinguishing between capital leases and operating leases in the current accounting literature. The result of retaining a distinction between finance leases and operating leases is that under the lessee accounting model in Topic 842, the effect of leases in a statement of operations and a statement of cash flows is largely unchanged from previous GAAP.  The amendments in this ASU are effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Earlier application is permitted. We are currently evaluating the impact that the adoption of this ASU will have on our financial statements. Although we have not finalized our process of evaluating the impact of adoption of the ASU on our financial statements we expect there will not be a material increase to assets and liabilities on our balance sheet for leases currently classified as operating leases.

 In January 2016, the FASB issued ASU No. 2016-01 "Financial Instruments-Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities." ASU 2016-01 amends various aspects of the recognition, measurement, presentation, and disclosure for financial instruments. With respect to the Company's financial statements, the most significant impact relates to the accounting for equity investments. It will impact the disclosure and presentation of financial assets and liabilities. ASU 2016-01 is effective for annual reporting periods, and interim periods within those years, beginning after December 15, 2017. Early adoption by public entities is permitted only for certain provisions. We do not believe that the adoption of this standard will have a material impact on our financial statements.
In November 2015, the FASB issued ASU No. 2015-17 "Income Taxes: Balance Sheet Classification of Deferred Taxes". ASU 2015-17 simplifies the balance sheet classification of deferred taxes and requires that all deferred taxes be presented as noncurrent. ASU 2015-17 is effective for fiscal years beginning after December 15, 2016 with early adoption permitted. The adoption of this update did not have a material effect on our financial statements.
In May 2014, the FASB issued Accounting Standards Update No. 2014-09 (Topic 606) "Revenue from Contracts with Customers." Topic 606 supersedes the revenue recognition requirements in Accounting Standards Codification Topic 605, "Revenue Recognition", and requires entities to recognize revenue when they transfer control of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. We are currently assessing the method of adoption and the impact this new guidance will have on our financial statements. We expect to adopt these standards using the modified retrospective method. The timing of revenue recognition for variable consideration under our licensing and collaboration agreements may be different as a result of this new guidance. We are reviewing our licensing agreement for variable consideration, and if any such consideration exists, whether it should be estimated and recognized earlier than under the current revenue guidance.
In August 2015, the FASB issued ASU No. 2015-14, "Revenue from Contracts with Customers" ("ASU 2015-14") which deferred the effective date by one year to December 15, 2017 for interim and annual reporting periods beginning after that date and allows for adoption using a full retrospective method, or a modified retrospective method. We will adopt the new standard in our first quarter 2018 using the modified retrospective method and are currently in the process of evaluating the impact of the adoption of this standard on our financial statements.
CytRx 2017 10-K Page #37#


related disclosures.

Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Historically, our exposure to market risk is limited primarily to interest income sensitivity, which is affected by changes in the general level of U.S. interest rates, particularly because a significant portion of our investments are in short-term debt securities issued by the U.S. government and institutional money market funds. The primary objective of our investment activities is to preserve principal. Due to the short-term nature of our investments, we believe that we are not exposed to any material market risk. We do not have any speculative or hedging derivative financial instruments or foreign currency instruments. If interest rates had varied by 10% in the year ended December 31, 2017,2023, it would not have had a material effect on our results of operations or cash flows for that period.

Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

Our consolidated financial statements and supplemental schedule and notes thereto as of December 31, 20172023 and 2016,2022, and for each of the three years in the period ended December 31, 2017,2023 and 2022, together with the reports thereon of our independent registered public accounting firm, are set forth beginning on page F-1 of this Annual Report.

Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE


Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

None.

Item 9A. CONTROLS AND PROCEDURES

Conclusion Regarding the Effectiveness of

Disclosure Controls and Procedures

Our management, with the participation of our principal executive officer and principal financial officer, performed an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Securities Exchange Act Rule 13a-15(e)) as of December 31, 2017,2023, the end of the period covered by this Annual Report. Based on this evaluation, our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures were effective as of December 31, 2017,2023, as described further below.

There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2017 that materially affected, or are reasonably likely to have a material effect, on our internal control over financial reporting.
Management's

Management’s Report on Internal Control Over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule 13a-15(f). Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we assessed the effectiveness of our internal control over financial reporting as of December 31, 2017.2023. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission ("COSO"(“COSO”) in Internal Control-Integrated Framework (2013 Edition)("the Framework"). Based upon management'smanagement’s assessment using the criteria contained in COSO, management has concluded that our internal control over financial reporting was effective as of December 31, 2017.2023.

53
 Our

Changes in Internal Control over Financial Reporting

There have been no changes in our internal control over financial reporting as of(as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the year ended December 31, 2017 has been audited by BDO USA, LLP, an independent registered public accounting firm, as stated in their report below.

CytRx 2017 10-K Page #38#


Report of Independent Registered Public Accounting Firm
Board of Directors and Stockholders
CytRx Corporation
Los Angeles, California
Opinion2022 that have materially affected, or are reasonably likely to have a material affect, on Internal Control over Financial Reporting
We have audited CytRx Corporation's (the "Company's")our internal control over financial reporting as of December 31, 2017, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (the "COSO criteria"). In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2017, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) ("PCAOB"), the balance sheets of the Company and subsidiaries as of December 31, 2017 and 2016, the related statements of operations, stockholders' equity, and cash flows for each of the three years in the period ended December 31, 2017, and the related notes and financial statement schedule of valuation and qualifying accounts and our report dated March 16, 2018 expressed an unqualified opinion thereon.
Basis for Opinion
The Company's management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying "Item 9A, Management's Report on Internal Control over Financial Reporting." Our responsibility is to express an opinion on the Company's internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit of internal control over financial reporting in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audit also included performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control over Financial Reporting
A company's internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company's internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ BDO USA, LL
Los Angeles, California
March 16, 2018

CytRx 2017 10-K Page #39#



reporting.

Item 9B. OTHER INFORMATION


None.

CytRx 2017 10-K Page #40#


Item 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

Not applicable.

PART III

Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

The following table sets forth information concerning our directors and executive officers:

NameAge

Class of

Director (1)

(2)

Position
Steven A. KriegsmanJennifer K Simpson, Ph.D.5576IIIIIDirector, ChairmanChair of the Board and (3)
Joel Caldwell68IIDirector(2))
Cary Claiborne63IDirector(2) (3)
Stephen Snowdy, Ph.D.55Chief Executive Officer
Louis Ignarro, Ph.D.76      ILead Director (2) (3) (4) (5)
Joel Caldwell62IIIDirector (2) (4) (5)
Earl Brien. M.D.57IIIDirector (2) (3) (4) (5)
John Y. Caloz7166Chief Financial Officer
Felix Kratz, Ph.D.55 and Senior Vice President-Drug DevelopmentVice-President
____________

(1)Our Class I director serves until the 20192025 annual meeting of our stockholders, our Class II directors servedirector serves until the 20202026 annual meeting of our stockholders and our Class III directors servedirector serves until the 20182024 annual meeting of our stockholders.

(2)
(2)Members of our Audit Committee. Mr. Caldwell is Chairman of the Committee.

(3)
(3)Members of our Nominating and Corporate GovernanceCompensation Committee. Dr. IgnarroMr. Claiborne is Chairman of the Committee.

(4)Members of our Compensation Committee. Dr. Ignarro is Chairman of the Committee.

(5)Members of our Strategy Committee. Dr. Brien is Chairman of the Committee.

Steven A. Kriegsman has been CytRx's

Jennifer Simpson, Ph.D. joined our Board in July 2021. She was appointed Chair of the Board on July 27, 2022. Dr. Simpson serves as President and Chief Executive Officer and a director since July 2002. In October 2014, he was elected Chairman of the Board. Mr. Kriegsman served on the boards of directors of Galena Biopharma, Inc. from 2009 until 2016 and Catasys, Inc. from November 2013 to August 2015. He previously served as Director and Chairman of Global Genomics from June 2000 until 2002. Mr. Kriegsman is an inactive Chairman and the founder of Kriegsman Capital Group LLC, a financial advisory firm specializing in the development of alternative sources of equity capital for emerging growth companies in the healthcare industry. During his career, he has advised such companies as SuperGen Inc., Closure Medical Corporation, Novoste Corporation, Miravant Medical Technologies, and Maxim Pharmaceuticals. In the past, Mr. Kriegsman has also served on the Board of Directors of Bradley Pharmaceuticals, Inc. and Hythiam, Inc. Mr. Kriegsman has a B.S. degree with honors from New York University in Accounting and completed the Executive Program in Mergers and Acquisitions at New York University, The Management Institute. Mr. Kriegsman is a graduate of the Stanford Law School Directors' College

Mr. Kriegsman was formerly a Certified Public Accountant with KPMG in New York City. In February 2006, Mr. Kriegsman received the Corporate Philanthropist of the Year Award from the Greater Los Angeles Chapter of the ALS Association and in October 2006, he received the Lou Gehrig Memorial Corporate Award from the Muscular Dystrophy Association. Mr. Kriegsman has been a guest speaker and lecturer at various universities including California Institute of Technology (Caltech), Brown University, and New York University. He also was an instructor at York College in Jamaica (Queens), NY, where he taught business to a diverse group of students in York's adult education program. Mr. Kriegsman has been active in various charitable organizations including the Biotechnology Industry Organization, the California Health Institute, the ALS Association, the Los Angeles Venture Association, the Southern California Biomedical Council, the American Association of Dance Companies and the Palisades-Malibu YMCA.
Mr. Kriegsman's extensive history as a member of management is vital to the board of directors' collective knowledge of our day-to-day operations. Mr. Kriegsman also provides great insight as to how CytRx grew as an organization and his institutional knowledge is an invaluable asset to the board of directors of Panbela Therapeutics since July 2020. She most recently served as President and Chief Executive Officer and as a member of the board of directors of Delcath Systems, Inc. from 2015 to June 2020. She had previously held various other leadership roles at Delcath since 2012. From 2011 to 2012, Dr. Simpson served as Vice President, Global Marketing, Oncology Brand Lead at ImClone Systems, Inc. (a wholly owned subsidiary of Eli Lilly and Company), where she was responsible for all product commercialization activities and launch preparation for one of the late-stage assets. From 2009 to 2011, Dr. Simpson served as Vice President, Product Champion and from 2008 to 2009 as the Associate Vice President, Product Champion for ImClone’s product Ramucirumab. From 2006 to 2008, Dr. Simpson served as Product Director, Oncology Therapeutics Marketing at Ortho Biotech (now Janssen Biotech), a Pennsylvania-based biotech company that focuses on innovative solutions in effecting its oversight of CytRx's strategic plans. Mr. Kriegsman's presenceimmunology, oncology and nephrology. Earlier in her career, Dr. Simpson spent over a decade as a hematology/oncology nurse practitioner and educator. Dr. Simpson has served on the board of directors also allows for a flowand nominating and corporate governance committee of information and ideas between the board of directors and management.
Louis Ignarro, Ph.D. Eagle Pharmaceuticals, Inc. since August 2019. has been a director since July 2002. He previously2002 and has served as a directorthe Chairman of Global Genomics from November 2000 until 2002.the Board’s Compensation Committee since December 2016. Dr. Ignarro serves as the Jerome J. Belzer, M.D. Distinguished Professor of PharmacologySimpson’s experience in the Departmentfield of Molecularclinical development and Medical Pharmacology atoncology will be very helpful to the UCLA School of Medicine. Retired in 2013, Dr. Ignarro had been atBoard and the UCLA School of Medicine since 1985 as a professor, acting chairman and assistant dean. Dr. Ignarro received the Nobel Prize for Medicine in 1998.Company.

54
Dr. Ignarro received a B.S. in pharmacy from Columbia University and his Ph.D. in Pharmacology from the University of Minnesota. Dr. Ignarro is a Nobel Laureate and an esteemed medical researcher whose experience enables him to offer importance scientific guidance to our Board of Directors. In December 2016, Dr. Ignarro was appointed Lead Director.
CytRx 2017 10-K Page #41#


Joel Caldwell joined our Board of Directors on July 12, 2017. HeMr. Caldwell brings more than 30 years of experience in tax matters, finance, and internal auditing. HeMr. Caldwell retired from Southern California Edison, one of the nation'snation’s largest public utilities, where he had been employed for 28 years in various executive-level accounting and finance positions covering Internal Audits, Executive Compensation, Long Term Finance, Employee Benefits and, most recently prior to his retirement, Sarbanes-Oxley Internal Controls Compliance. He also worked in public accounting at the firm of Arthur Andersen & Co. In 1980, Mr. Caldwell earned his MBA with a major in finance from the University of California at Berkeley. Prior to that, heMr. Caldwell received a Bachelor of Science degree in Accounting and Finance, also from the University of California at Berkeley. HeMr. Caldwell has been a Certified Public Accountant in California since 1982 and a Certified Internal Auditor since 1986. Mr. Caldwell volunteers his business skills, serving as a financial advisor on the board of trustees of a charitable organization, and continues his involvement with track and field sports by volunteering as a meet official at Pacific Palisades Charter High School. HeMr. Caldwell is a member of both the American Institute of Certified Public Accountants and the California Society of Certified Public Accountants.

Mr. Caldwell's Caldwell’s diverse background in accounting, auditing and finance, along with his accreditation as a member of both the American Institute of Certified Public Accountants and the California Society of Certified Public Accountants will provide the board with a balanced perspective to enhance its stewardship and fulfill his role as the named financial expert on our Audit Committee.

Earl Brien, M.D.

Cary Claiborne joined our boardBoard in July 2022. Mr. Claiborne has served on the Board of directors inDirectors of NeuroSense Therapeutics since December 2016. He is a renowned orthopedic and sarcoma surgeon who2021, where he also serves as chair of the audit committee. Mr. Claiborne has served as the Chief Executive Officer since August 18, 2022 and prior to that as Chief Operating Officer since December 2021 and a Professor of Orthopedic Surgery and as the Surgical Director of the Sarcoma Service at Cedars Sinai Medical Center in Los Angeles, Californiadirector since February 2008. After completing his matriculation asNovember 2021 for Adial Pharmaceuticals Inc. (“Adial”) a Fellow at Memorial Sloan Kettering Cancer Center and the Hospital for Special Surgery in musculoskeletal tumors and metabolic bone disease respectively, he became the Director of the Musculoskeletal Tumor Program and Metabolic Bone Disease Center at Orthopedic Hospital. Dr. Brien is the recipient of numerous grants, with an extensive bibliography of peer-reviewed articles spanning more than twenty yearspublic biopharmaceutical company. Prior to his credit. He has also represented at national and international meetings for the past twenty years. From 1993 until 2004, hejoining Adial, Mr. Claiborne served as the Cancer CommissionCEO of Prosperity Capital Management, LLC, a US based private investment and advisory firm that he founded. From 2014 until 2017, Mr. Claiborne served as the Chief Financial Officer and board member of Indivior PLC. a public global commercial stage pharmaceutical company. Mr. Claiborne was also a director on the Board of Directors of New Generation Biofuels Inc. and MedicAlert Foundation, where he also served as the chair of the audit and finance committees. From 2011 to 2014, Mr. Claiborne was the Chief Financial Officer of Sucampo Pharmaceuticals Inc., a public global biopharmaceutical company focused on drug discovery, development, and commercialization. Mr. Claiborne graduated from Rutgers University with a B.A. in Business Administration. He also holds an M.B.A from Villanova University and was previously a NACD Governance Fellow. His diverse background in the pharmaceutical industry and finance will provide the board with a balanced perspective and will be very helpful to the Board and the Company.

Stephen Snowdy, Ph.D. was appointed Chief Executive Officer on January 3, 2022, effective January 10, 2022. Dr. Snowdy is a scientist, serial entrepreneur and medical venture capitalist with two decades of experience in life science investing and executive management. Dr. Snowdy joins from Visioneering Technologies, Inc. (ASX: VTI), where he was Chief Executive Officer and Executive Director. Dr. Snowdy previously served as Chief Executive Officer at Abby Med LLC, a start-up pharmaceutical company dedicated to the development of a novel class of cancer drugs. Prior to that, Dr. Snowdy was Chairman and Cancer Liaison PhysicianChief Executive Officer of Calosyn Pharma, Inc., a Phase 2 osteoarthritis company, and was a partner for several years at a top-tier medical venture capital firm. Dr. Snowdy simultaneously earned a PhD in Neurobiology and an MBA from the American CollegeUniversity of Surgeons Commission on CancerNorth Carolina. Dr. Snowdy studied Chemical Engineering and Chemistry at Orthopedic Hospital.

the University of Florida, where he also completed two years of postbaccalaureate study in cardiopharmacology. His academic training followed service in the United States Navy Special Forces.

John Y. Caloz joined us in October 2007 as our Chief Accounting Officer. In January of 2009, Mr. Caloz was named Chief Financial Officer. HeIn August of 2020 he was named Senior Vice-President and on May 11, 2023, he was named Corporate Secretary. Mr. Caloz has a history of providing senior financial leadership in the life sciences sector, as Chief Financial Officer of Occulogix, Inc, a NASDAQ listed, medical therapy company. Prior to that, Mr. Caloz served as Chief Financial Officer of IRIS International Inc., a Chatsworth, CA based medical device manufacturer. HeMr. Caloz served as Chief Financial Officer of San Francisco-based Synarc, Inc., a medical imaging company, and from 1993 to 1999 he was Senior Vice President, Finance and Chief Financial Officer of Phoenix International Life Sciences Inc. of Montreal, Canada, which was acquired by MDS Inc. in 1999. Mr. Caloz was a partner at Rooney, Greig, Whitrod, Filion & Associates of Saint Laurent, Quebec, Canada, a firm of Chartered Accountants specializing in research and development and high-tech companies from 1983 to 1993.1993, Mr. Caloz, a Chartered Professional Accountant and Chartered Accountant, holds a degree in Accounting from York University, Toronto, Canada.

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Felix Kratz, Ph.D. joined CytRx

Family Relationships

There are no family relationships among our directors and executive officers.

Involvement in 2014 as Vice President, Drug Discovery. He is a medicinal chemist with more than 25 yearsCertain Legal Proceedings

None of pertinent experienceour directors or executive officers has been involved in any of the preclinical development of anticancer drugs, prodrugs and protein conjugation chemistry and profound knowledge of translational research fromfollowing events during the laboratory to the clinic. He has successfully transferred aldoxorubicin, CytRx clinical lead compound, from bench to bedside that is based on an innovative drug delivery platform exploiting circulating albumin as a tumor-specific drug carrier. Felix Kratz graduated in Chemistry from the University of Heidelberg with Magna Cum Laude. Prior to joining CytRx Corporation he established the Division of Macromolecular Prodrugs at the Tumor Biology Center Freiburg. He serves on the Editorialpast ten years:

any bankruptcy petition filed by or against any business of which such person was a general partner or executive officer either at the time of the bankruptcy or within two years prior to that time;
any conviction in a criminal proceeding or being subject to a pending criminal proceeding (excluding traffic violations and other minor offences);
being subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoining, barring, suspending or otherwise limiting his or her involvement in any type of business, securities or banking activities; or
being found by a court of competent jurisdiction (in a civil action), the SEC or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended, or vacated.

Diversity

Our Board for Bioconjugate Chemistry, Current Medicinal Chemistry, Current Bioactive Compounds, and Pharmacology & Pharmacy and has authored approximately 260 scientific publications, book articles and proceedings and is the inventor of over 20 patents and patent applications. He heads the CytRx Drug Discovery Branch located in the Innovation Center Freiburg, Germany.

Diversity
Our board of directors, acting through the Nomination and Governance Committee, is responsible for assembling for stockholder consideration director-nominees who, taken together, have appropriate experience, qualifications, attributes, and skills to function effectively as a board. The Nomination and Governance CommitteeBoard periodically reviews theits composition of the board of directors in light of our changing requirements, its assessment of the board of directors'its performance, and the input of stockholders and other key constituencies. The Nomination and Governance CommitteeBoard looks for certain characteristics common to all board members, including integrity, strong professional reputation and record of achievement, constructive and collegial personal attributes, and the ability and commitment to devote sufficient time and energy to board service. In addition, the Nomination and Governance Committee seeksthey seek to include on the board of directorsBoard a complementary mix of individuals with diverse backgrounds and skills reflecting the broad set of challenges that the board of directorsBoard confronts. These individual qualities can include matters such as experience in our company'scompany’s industry, technical experience (i.e., medical or research expertise), experience gained in situations comparable to the company's,company’s, leadership experience, and relevant geographical diversity.
CytRx 2017 10-K Page #42#


Corporate Governance

Board Committees,

Meetings and Attendance

Our business, property and affairs are managed by or under the direction of the board of directors. Members of the board are kept informed of our business through informal discussions with our chief executive and financial officers and other officers, by reviewing materials provided to them and by participating at meetings of the board and its committees.

Our board of directorsBoard currently has four committees.two committees, the Audit Committee, in accordance with section 3(a)(58)(A) of the Securities Exchange Act of 1934, as amended (the “Securities Act”), and the Compensation Committee. The Audit Committee consists of Mr. Caldwell Dr. Ignarro and Dr. Brien.Mr. Claiborne. The Chairman of the Audit Committee is Mr. Caldwell. The Compensation Committee consists of Dr. Ignarro, Mr. CaldwellClaiborne and Dr. Brien;Simpson. Mr. Claiborne is the Nomination and GovernanceChairman of the Compensation Committee. The Audit Committee consists of Dr. Ignarro and Dr. Brien, and the StrategyCompensation Committee consists of Dr. Brien, Dr Ignarro and Mr. Caldwell. Such committees operate under formal charters that govern their duties and conduct. Copies of the charters are available on our website at www.cytrx.com.www.ladrx.com.

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Our board of directorsBoard has determined that Mr. Caldwell, one of the independent directors serving on our Audit Committee, is an "audit“audit committee financial expert"expert” as defined by the SEC'sSEC’s rules. Our board of directorsBoard has determined that Dr. Ignarro,Mr. Claiborne and Mr. Caldwell and Dr. Brien are "independent"“independent” under the current independence standards of both The NASDAQ CapitalOTC Market and the SEC.

In the year ended December 31, 2023, the Board met five times, the Audit Committee met four times and the Compensation Committee met once.

Section 16(a) Beneficial Ownership Reporting Compliance

Delinquent Section 16(a) Reports

Each of our executive officers and directors and persons who own more than 10% of our outstanding shares of common stock is required under Section 16(a) of the Securities Exchange Act to file with the SEC initial reports of ownership and reports of changes in ownership of our common stock and to furnish us with copies of those reports. BasedTo our knowledge, based solely on our review of copies of reports we have received and written representations from certain reporting persons, we do not believe that there were any delinquent filers. We believe our directors and executive officers and greater than 10% shareholders for 2014the year ended December 31, 2023 complied with all applicable Section 16(a) filing requirements.

Code of Ethics

We have adopted a Code of Ethics applicable to all employees, including our principal executive officer, principal financial officer and principal accounting officer, a copy of which is available on our website at www.cytrx.com.www.ladrx.com. We will furnish, without charge, a copy of our Code of Ethics upon request. Such requests should be directed to Attention: Corporate Secretary, 11726 San Vicente Boulevard, Suite 650, Los Angeles, California, or by telephone at 310-826-5648.

Insider Trading Policy

We have adopted an insider trading policy governing the purchase, sale, and/or other dispositions of our securities by our directors, officers and employees. The insider trading policy is designed to promote compliance with insider trading laws, rules and regulations.

Board Leadership Structure

 On October 15, 2014,

Our Certificate of Incorporation and our boardBylaws previously provided for the classification of our directors appointed Mr. Kriegsmaninto three classes, which we refer to as ChairmanClass I, Class II and Class III, with each class to consist as nearly as possible of an equal number of directors.

At the Board.  The Chairman2022 Annual Meeting, a Declassification Proposal to declassify the structure of the Board presides at all meetingswas passed on a precatory basis, which advised the Board that a majority of our boardstockholders desired to end the classified Board structure in favor of the annual election of directors, (but not at its executive sessions)in which each director standing for election will only be eligible to be elected for one-year terms. At the 2023 Annual Meeting, the stockholders approved the Board’s adoption of a resolution approving and exercises and performs such other powers and duties as may be assigned to him from time to time bydeclaring the board or prescribed byadvisability of amending our amended and restated bylaws.

Our board of directors has no established policy on whether it should be led by a Chairman who is also the Chief Executive Officer, but periodically considers whether combining, or separating, the role of Chairman and Chief Executive Officer is appropriate. At this time, our board is committedgoverning documents to the combined role given the circumstances of our company, including Mr. Kriegsman's knowledge of the pharmaceutical industry and our company's strategy.  Our board believesextent necessary to remove provisions that havingprovide for a Chairman who also serves as the Chief Executive Officer allows timely communication with our board on company strategy and critical business issues, facilitates bringing key strategic and business issues and risks to the board's attention, avoids ambiguity in leadership within the company, providesclassified Board. This resolution provided for a unified leadership voice externally and clarifies accountability for company business decisions and initiatives.  In December 2016, Dr. Ignarro was appointed as an independent Lead Director to act as a liaison between the Chairmanrolling declassification of the Board to be completed by the 2026 annual meeting of the stockholders.

On September 8, 2023, we filed a Certificate of Amendment of Restated Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of State of Delaware to amend and restate in its entirety Section 2 of Article Eighth of our Restated Certificate of Incorporation to effect the declassification of our Board as approved by our stockholders. Our board also amended certain provisions of our Amended and Restated By-Laws (the “By-Laws”) consistent with the Certificate of Amendment. Following the filing of the Certificate of Amendment and the independent directors. The boardamendment of our By-Laws, our Class I director will continue to assess whether this leadership structure is appropriateserve until the 2025 annual meeting of our stockholders, our Class II director will serve until the 2024 annual meeting of our stockholders, and our Class III director will adjust it as it deems appropriateserve until the 2026 annual meeting of our stockholders.

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Board of Directors Role in Risk Oversight

In connection with its oversight responsibilities, our board of directors,Board, including the Audit Committee, periodically assesses the significant risks that we face. These risks include, but are not limited to, financial, technological, competitive, and operational risks. Our board of directorsBoard administers its risk oversight responsibilities through our Chief Executive Officer and Chief Financial Officer who review and assess the operations of our business, as well as operating management'smanagement’s identification, assessment and mitigation of the material risks affecting our operations.

CytRx 2017 10-K Page #43#


Item 11. EXECUTIVE COMPENSATION

Compensation Discussion and Analysis
Overview of Executive Compensation Program
The Compensation Committee of our Board of Directors has responsibility for establishing, implementing and monitoring our executive compensation program philosophy and practices. Generally speaking, the Compensation Committee determines the compensation of our Chief Executive Officer and other named executive officers with the approval of our Board of Directors.
The Compensation Committee seeks to ensure that the total compensation paid to our named executive officers is fair, reasonable and competitive. Generally, the types of compensation and benefits provided to the named executive officers are similar to those provided to our other officers.
The Compensation Committee operates under a formal charter, a copy of which is available on our website at www.cytrx.com that governs its duties and conduct.
At the 2017 annual meeting of stockholders, the stockholders on a non-binding, advisory basis, approved the compensation of our executive officers as disclosed in our 2017 proxy statement. Based upon the results of this stockholder advisory vote, the Compensation Committee determined to continue its compensation policies and procedures.
Throughout this Annual Report, the individuals included in the

Summary Compensation Table below are referred to as our "named executive officers."

Compensation Philosophy and Objectives
The components of our executive compensation consist of salary, annual and special cash bonuses awarded based on the Compensation Committee's subjective assessment of the achievement of corporate goals and each individual executive's job performance, stock option grants to provide executives with longer-term incentives, and occasional special compensation awards (either cash, stock or stock options) to reward extraordinary efforts or results.
The Compensation Committee believes that an effective executive compensation program should provide base annual compensation that is reasonable in relation to individual executive's job responsibilities and reward the achievement of strategic goals of our company. We use annual and other periodic cash bonuses to reward an officer's achievement of specific goals, including goals related to the development of our drug candidates and replenishment and management of our working capital. We use employee stock options as a retention tool and as a means to align the executive's long-term interests with those of our stockholders, with the ultimate objective of affording our executives an appropriate incentive to improve stockholder value. The Compensation Committee evaluates both performance and compensation to maintain our company's ability to attract and retain excellent employees in key positions and to assure that compensation provided to key employees remains competitive relative to the compensation paid to similarly situated executives of comparable companies.
Each of the corporate goals established and subsequently reviewed by the Compensation Committee results from a collaboration among our named executive officers, including the leadership of our Chief Executive Officer and the support of our principal legal, financial, clinical, medical, commercial and business development officers. The Compensation Committee's assessment of the relative contribution of each named executive officer is based on periodic reports to our full Board of Directors regarding the progress of these business accomplishments and the individual efforts of our named executive officers, and year-end consultations, which include discussions of performance reviews, with our Chief Executive Officer that are a normal part of the Compensation Committee's compensation determinations. The Compensation Committee employs no objective measure of any individual's contribution.
The bonus amounts awarded to our eligible named executive officers are a function of their office and total compensation relative to the total compensation of our Chief Executive officer, based upon their employee evaluations, and with consideration given to comparable companies for similarly-situated employees. The bonus amounts awarded to each named executive officer is set forth in the Summary Compensation Table.
Because of the size of our company, the small number of executive officers in our company, and our company's financial priorities, the Compensation Committee has not implemented any pension benefits, deferred compensation plans or other similar plans for our named executive officers.
CytRx 2017 10-K Page #44#


Role of Executive Officers in Compensation Decisions
The Compensation Committee annually determines the compensation of our named executive officers. Mr. Kriegsman, our Chairman of the Board and Chief Executive Officer, typically attends all meetings of the Compensation Committee, except for executive sessions at which his compensation is discussed. At the request of the Compensation Committee, Mr. Kriegsman provides his assessment of the performance of our named executive officers, other than himself. Mr. Kriegsman also takes an active part in the discussions of the compensation of named executive officers other than himself and assists in the development of a review matrix of each executive's contributions to the goals of the company that forms the basis for some compensation determinations. The Compensation Committee grants due consideration to Mr. Kriegsman's assessments when making determinations regarding the compensation of our named executive officers. All Compensation Committee deliberations and determinations regarding the compensation of Mr. Kriegsman are made outside his presence.
Setting Executive Compensation
Based on the foregoing objectives, the Compensation Committee has structured the company's annual cash and incentive-based cash and non-cash executive compensation to seek to motivate our named executives to achieve our company's business goals, including goals related to the development of our drug candidates and management of working capital, to reward the executives for achieving such goals, and to retain the executives. In doing so, the Compensation Committee historically has not employed outside compensation consultants or legal advisors. During 2017, the Compensation Committee used two industry compensation surveys in its compensation deliberations regarding cash and equity compensation for our executive officers. The surveys used were Radford Global Life Sciences Survey, which is a survey of public and private life sciences companies of all sizes, including those companies with under fifty employees and a survey of public and private companies in Los Angeles provided by salary.com (which the Compensation Committee uses to consider geographic differences in cost of living).
The Compensation Committee utilized this data to set annual salary increases and bonus amounts for our executive officers at levels targeted at or around the third quartile of compensation amounts provided to executives at comparable companies, considering each individual's experience level related to their position with us. The Compensation Committee has no policy regarding the use of benchmarks, and we have no established policy or target for the allocation between cash and non-cash incentive compensation.
The Compensation Committee is authorized to retain its own independent advisors to assist in carrying out its responsibilities, but has not relied upon outside compensation consultants or legal advisors.
Performance-driven Compensation
We emphasize performance in annually reviewing and setting our executive officers' base salaries, bonuses and equity incentive compensation. This emphasis on performance is intended to motivate our executive officers to pursue our corporate goals, reward them for achievement of these goals and align their interests with those of our stockholders.
Each year, we determine goals that we hope to achieve in the coming year, both on a company and individual basis. Our overall corporate performance as compared to these goals, and an individual's performance compared to his or her individual goals, primarily drive the recommendations that the Compensation Committee with respect to each executive officer's base salary, cash bonus and equity incentive compensation. Other factors, such as larger macroeconomic conditions of the industry and market in which we compete, as well as strategic business decisions and issues related to key employee retention, also influence compensation decisions.
CytRx 2017 10-K Page #45#


Individual performance goals for each year initially are identified and developed by senior executives through a self-evaluation and goal-setting process, and our CEO refines and documents those goals in conjunction with the Compensation Committee. At the end of the year, the Compensation Committee reviews each performance goal and determines the extent to which we achieved such goals, and our CEO assesses the achievement of specific performance goals relating to our other executive officers.
In establishing performance goals, the Compensation Committee considers whether the goals could possibly result in an incentive for any executives to take unwarranted risks in our company's business and seeks to avoid creating any such incentives.
Company Performance Goals
For 2017, the Compensation Committee and our board of directors approved the following performance goals:
·Analyze the primary endpoint from the Phase 2 SCLC clinical trial;
·Completion of drug substance and drug product registration batches for aldoxorubicin;
·Meet with the FDA re 505(b)(2) NDA submission;
·Submit two ASCO abstracts;
·Identify an in vivo proof of concept for at least one ultra-potent albumin-binding drug candidate, and file provisional patent applications; and
·Raise additional capital.
For 2017, the Compensation Committee determined that, with the exception of the completion of registration batches for aldoxorubicin and the analysis of the Phase 2 SCLC clinical trial, both of which became no longer applicable with the execution of the licensing agreement with NantCell, each of the corporate goals had been achieved, and noted the particular contributions of executive officers to the achievement of those goals.
Individual Performance
The Compensation Committee reviews our executive officers' performance based on overall achievement of the corporate goals and a review of individual goals developed for each executive officer every year. The Compensation Committee, with the assistance of our Chief Executive Officer, determines the relative achievement of the performance goals applicable to each executive officer, and assigns a performance rating based on a set of criteria set forth in an evaluation form. No specific formula is used with respect to setting any particular element of compensation based on the individual performance metrics. The score assigned to each officer was based on a subjective assessment by our Compensation Committee members of the officer's performance against the scoring standards of:
5 – Consistently Exceeds Expectations
4 – Sometimes Exceeds Expectations
3 – Meets Expectations
2 – Sometimes Meets Expectations
1 – Needs Improvement
The numerical job scores, with a 5.0 being the best and 1.0 being the worst, are determined based on an initial self-assessment by the officer, which is subject to change based on an evaluation of the self-assessment by the officer's direct supervisor and on the Compensation Committee's own assessment of the officer's job performance.
CytRx 2017 10-K Page #46#


For 2017, our Compensation Committee determined that the individual performance scores indicated below were merited by the officer's respective contributions to our key business achievements discussed above, as well as the performance of their day-to-day responsibilities. On an officer-by-officer basis, our Compensation Committee also considered the following:
Mr. Kriegsman's individual performance goals relate primarily to overall corporate objectives, including building stockholder value as reflected in our market capitalization and our working capital, managing and directing the executive management team, and successfully developing our company's operations and personnel for future success. Based on those criteria, and the fact the Company was able to sign an exclusive licensing agreement with NantCell, the Compensation Committee gave a rating of 4.8 to Mr. Kriegsman.
Mr. Caloz's individual performance goals relate primarily to achievement of key financial objectives, such as managing and raising working capital, controlling spending, managing accounting personnel and maintaining regulatory compliance. Based on those criteria, the Compensation Committee noted Mr. Caloz's role in obtaining needed working capital, his efforts to control expenditures, the continued improvement of our accounting department, and our compliance with filing deadlines, and gave a rating of 4.7 to Mr. Caloz.
Dr. Kratz's individual performance goals relate primarily to the execution of the objectives related to our drug discovery unit, including identifying at least one ultra-potent albumin-binding drug candidate, managing the drug discovery laboratory within budget and maintaining a strong scientific team. Based on those criteria, the Compensation Committee gave a rating of 4.0 to Dr. Kratz.
2017 Executive Compensation Components
For 2017, as in recent years, the principal components of compensation for the named executive officers were:
·base salary;
·annual bonuses; and
·equity incentive compensation.
Base Salary
We provide named executive officers and other employees with base salary to compensate them for services rendered during the year. Generally, the base salary element of compensation is used to recognize the experience, skills, knowledge and responsibilities required of each named executive officer, and reflects our executive officers' overall sustained performance and contributions to our business.
During its review of base salaries for executives, the Compensation Committee primarily considers:
·the negotiated terms of each executive's employment agreement, if any;
·each executive's individual performance;
·an internal review of the executive's compensation, both individually and relative to other named executive officers; and
·to a lesser extent, base salaries paid by comparable companies.
Salary levels are typically considered annually as part of our company's performance review process, as well as upon a change in job responsibility. Merit-based increases to salaries are based on our company's available resources and the Compensation Committee's assessment of the individual's performance. This assessment is based upon written evaluations of such criteria as job knowledge, communication, problem solving, initiative, goal-setting, and expense management. In 2017, the Compensation Committee considered our successful achievement or substantial progress towards our corporate performance goals, and with consideration of the challenging financial environment, awarded no increases in base salary for 2018. Base salaries were also reviewed in light of the Radford and salary.com survey data to validate that they were within acceptable ranges based on market salaries.
CytRx 2017 10-K Page #47#



Annual and Special Bonuses
As we do not generate significant revenue and have not commercially released any products, the Compensation Committee bases its discretionary annual bonus awards on the achievement of corporate and individual goals, efforts related to extraordinary transactions, effective fund-raising efforts, effective management of personnel and capital resources, and bonuses paid by comparable companies, among other criteria. Mr. Kriegsman's employment agreement entitles him to an annual cash bonus in an amount to be determined in our discretion, but not less than $150,000. Any cash bonuses to our other named executive officers are entirely in our discretion.
During 2017, the Compensation Committee granted Mr. Kriegsman an annual cash bonus of $150,000, and granted the other named executive officers ranging from $75,000 to $100,000, principally based on their efforts in achieving the Company's corporate goals. In December 2017, the Compensation Committee approved an award to Mr. Kriegsman of a $0.7 million restricted stock grant, or 387,597 shares of our common stock based on the closing price of the Company's common stock at December 15th, the award date to vest in three equal annual installments.
Equity Incentive Compensation
We believe that strong long-term corporate performance is achieved with a corporate culture that encourages a long-term focus by our executive officers through the use of equity awards, the value of which depends on our stock performance. We have established equity incentive plans to provide all of our employees, including our executive officers, with incentives to help align those employees' interests with the interests of our stockholders and to enable them to participate in the long-term appreciation of our stockholder value. Additionally, equity awards provide an important retention tool for key employees, as the awards generally are subject to vesting over an extended period of time based on continued service with us.
Historically, equity awards have been granted annually at the end of each year based primarily on corporate performance as a whole during the preceding year. In addition, we may grant equity awards upon the occurrence of certain events during the year, for example, upon an employee's hire or achievement of a significant business objective such as positive results or other progress of our clinical trials or successful capital-raising efforts.
The Compensation Committee has established December 15 as the date for the annual grant of stock options. The December 15 date correlates to the approximate dates of our historical annual stock option grants, but otherwise was not based upon any particular methodology.  All stock option grants, other than initial stock option grants to new employees, are made at a meeting, whether in-person or telephonic, of the Compensation Committee and not by unanimous written consent, and the Compensation Committee determines the grantees, amounts, dates, and prices of all stock options and do not delegate these responsibilities.
No formula is used in setting equity award grants and the determination of whether to grant equity awards, or the size of such equity awards, to our executive officers; rather, it involves subjective assessments by our board of directors, Compensation Committee and, with respect to executive officers other than Mr. Kriegsman. Generally, annual equity awards are intended to encourage retention of experienced employees, and we consider individual performance and contributions during the preceding year to the extent our board of directors and Compensation Committee believe such factors are relevant. As with base salary and cash bonuses, for 2017 our board of directors and Compensation Committee also considered data from two surveys in determining equity award grants to our executive officers.
At a meeting of the Compensation Committee on December 15, 2017, the Compensation Committee granted to Mr. Kriegsman nonqualified stock options to purchase 208,334 shares of our common stock at a price of $1.75 per share, which equaled the closing market prices on December 15, 2017, the specified grant date. The options vest monthly over three years, provided that Mr. Kriegsman remains in our employ throughout such monthly vesting periods, unless Mr. Kriegsman's employment agreement is not renewed by us or by him upon expiration of its term on December 31, 2021, or his employment is terminated by us without "cause," or by reason of his "disability", upon FDA approval of aldoxorubicin, or by Mr. Kriegsman for "good reason," or due to his death. In any one of these events, the options will vest immediately and will remain exercisable for their full term. In addition, in connection with the annual review of our other named executive officers, at its December 15, 2017 meeting, the Compensation Committee granted to our other named executive officers nonqualified stock options to purchase an aggregate of 83,334 shares of our common stock. All of the stock options had an exercise price equal to $1.75, the closing market price on December 15, 2017, the specified grant date, and vest either bi-monthly over two years or monthly over three years, provided that such executives remain in our employ through such vesting periods unless, with respect to Mr. Caloz, his employment is terminated by us without "cause" or by reason of his "disability," or due to his death, in which cases the vested options will remain exercisable for their full term.
Generally speaking, we have not taken into consideration any amounts realized by our named executive officers from prior stock option or stock awards in determining whether to grant new stock options or stock awards. No named executive officers have exercised options since 2003.
CytRx 2017 10-K Page #48#


Retirement Plans, Perquisites and Other Personal Benefits
Our executive officers are eligible to participate in the same group insurance and employee benefit plans as our other salaried employees. These benefits include medical, dental, vision, and disability benefits and life insurance.
We have adopted a tax-qualified employee savings and retirement plan, our 401(k) Plan, for eligible U.S. employees, including our named executive officers. Eligible employees may elect to defer a percentage of their eligible compensation in the 401(k) Plan, subject to the statutorily prescribed annual limit. We may make matching contributions on behalf of all participants in the 401(k) Plan in an amount determined by our board of directors. We made matching contributions to the 401(k) Plan for 2017 of $78,000. Matching contributions immediately vest, as do all employee contributions. We intend the 401(k) Plan, and the accompanying trust, to qualify under Sections 401(k) and 501 of the Internal Revenue Code so that contributions by employees to the 401(k) Plan, and income earned (if any) on plan contributions, are not taxable to employees until withdrawn from the 401(k) Plan, and so that we will be able to deduct our contributions, if any, when made. The trustee under the 401(k) Plan, at the direction of each participant, may invest the assets of the 401(k) Plan in any of a number of investment options.
We generally do not provide any of our named executive officers with any other perquisites or personal benefits, other than benefits to Mr. Kriegsman provided for in his employment agreement. We are required by his employment agreement to carry a life insurance policy for Mr. Kriegsman in the amount of not less than $1.4 million under which Mr. Kriegsman's designee is the beneficiary. We purchased a policy with a face value of $2 million, for which we pay the premium, and Mr. Kriegsman immediately reimburses us for the premium relating to the $0.6 million of additional coverage. We periodically review the levels of perquisites and other personal benefits provided to our named executive officers. No changes to these benefits were made during 2017.
Employment Agreements and Severance Arrangements
We have entered into written employment agreements with each of our named executive officers. The main purpose of these agreements is to protect the company from business risks such as competition for the executives' service, loss of confidentiality or trade secrets, and solicitation of our other employees, and to define our right to terminate the employment relationship. The employment agreements also protect the executive from termination without "cause" (as defined) and, in Mr. Kriegsman's case, entitle them to resign for "good reason" (as defined). Each employment agreement was individually negotiated, so there are some variations in the terms among executive officers. Generally speaking, however, the employment agreements provide for termination and severance benefits that the Compensation Committee believes are consistent with industry practices for similarly situated executives. The Compensation Committee believes that the termination and severance benefits help the company retain the named executive officers by providing them with a competitive employment arrangement and protection against unknowns such as termination without "cause" that go along with the position.
In the event of termination without "cause," the named executive officers will be entitled to a lump-sum payment equal to six months' base salary (24 month's base salary and minimum annual bonus under his employment agreement in the case of Mr. Kriegsman). The named executive officers' agreements also provide for our continuation of medical benefits during the severance period (including, for Mr. Kriegsman, payments for life insurance). If a named executive officer's employment is terminated by us without "cause" (or by Mr. Kriegsman for "good reason") within two years following a change of control of the company, the named executive officers will be entitled to a lump-sum payment equal to 12 months' base salary (36 month' base salary and minimum annual bonus in the case of Mr. Kriegsman), and Mr. Kriegsman also would be entitled under his employment agreement to receive a "gross-up" payment equal to the sum of any excise tax on termination benefits (including any accelerated vesting of his options under our Plans as described below) plus any penalties and interest.
On January 10, 2017, we entered into an amendment with Mr. Kriegsman, under which the term of his employment agreement was extended by three years to December 31, 2021. We agree in Mr. Kriegsman's employment agreement that if there is a change in control and his employment agreement is either not renewed by either us or Mr. Kriegsman or, following the expiration of the employment agreement, we terminate Mr. Kriegsman's employment other than for "cause" or he resigns for "good reason," he will be entitled to the lump-sum severance and continuation of benefits described in the preceding paragraph for a change in control.
We agree in the employment agreements with our named executive officers (other than Mr. Kriegsman) that if we do not offer to renew or extend the officer's employment agreement, and we had not theretofore terminated their employment, we will continue to pay the officer his annual salary thereunder during the period commencing upon expiration of his employment agreement and ending on June 30, 2019, or the date of his re-employment with another employer, whichever is earlier.
In the event we terminate Mr. Kriegsman's employment without "cause," Mr. Kriegsman resigns for "good reason" or his employment terminates due to his "disability" (each as defined in the employment agreement) or death, he will be entitled to full and immediate vesting of his restricted stock and stock options and any other equity awards based on our securities and all such awards will remain exercisable for their full term notwithstanding the termination of his employment (other than a termination by the company for "cause" or their resignation without "good reason").
Change of Control Arrangements
In addition to the severance and benefits payable to our named executive officers in the event of a termination of their employment following a change of control of the company, our 2000 Long-Term Incentive Plan and 2008 Plan provide generally that, upon a change of control of the company, all unvested stock options and awards under the Plans held by plan participants, including the named executive officers, will become immediately vested and exercisable immediately prior to the effective date of the transaction. The Compensation Committee believes that such "single trigger" change of control policy is consistent with the objective of aligning the interests of the named executive officer's and of the company's stockholders by allowing the executives to participate equally with stockholders in the event of a change of control transaction.
The foregoing severance and change of control arrangements, including the quantification of the payments and benefits provided under these arrangements, are described in more detail elsewhere in this Annual Report under the heading "Executive Compensation – Employment Agreements and Potential Payment Upon Termination or Change in Control."
CytRx 2017 10-K Page #49#


Ownership Guidelines
The Compensation Committee has no requirement that named executive officers maintain a minimum ownership interest in our company.
Our long-term incentive compensation consists solely of periodic grants of stock options to our named executive officers. The stock option program:
·links the creation of stockholder value with executive compensation;
·provides increased equity ownership by executives;
·functions as a retention tool, because of the vesting features included in all options granted by the Compensation Committee; and
·helps us to maintain competitive levels of total compensation.
We normally grant stock options to new executive officers when they join our company based upon their position with us and their relevant prior experience. The options granted by the Compensation Committee generally vest monthly over the first three years of the ten-year option term. Vesting and exercise rights generally cease upon termination of employment (unless such termination is without cause or is a resignation for good reason), except in the case of death (subject to a one-year limitation), disability or retirement. Prior to the exercise of an option, the holder has no rights as a stockholder with respect to the shares subject to such option, including voting rights and the right to receive dividends or dividend equivalents. In addition to the initial option grants, our Compensation Committee may grant additional options to retain our executives and reward, or provide incentive for, the achievement of corporate goals and strong individual performance.
On an annual basis, the Compensation Committee assesses the appropriate individual and corporate goals for our executives and provides additional option grants based upon the achievement by the new executives of both individual and corporate goals. We expect that we will continue to provide new employees with initial option grants in the future to provide long-term compensation incentives and will continue to rely on performance-based and retention grants to provide additional incentives for current employees. Additionally, in the future, the Compensation Committee may consider awarding additional or alternative forms of equity incentives, such as grants of bonus stock, restricted stock and restricted stock units.
It is our policy to award stock options at an exercise price equal to The Nasdaq Capital Market's closing price of our common stock on the date of the grant. In certain limited circumstances, the Compensation Committee may grant options to an executive at an exercise price in excess of the closing price of the common stock on the grant date. The Compensation Committee will not grant options with an exercise price that is less than the closing price of our common stock on the grant date, nor will it grant options which are priced on a date other than the grant date. For purposes of determining the exercise price of stock options, the grant date is deemed to be the first day of employment for newly hired employees. Among our corporate governance practices, we will grant stock options to directors, officers and employees only on pre-set dates established by the Compensation Committee prior to the fiscal year in which the options are to be granted.  The Compensation Committee has established December 15 as the date for the annual grant of stock options.  The December 15 date correlates to the approximate dates of our historical annual stock option grants, but otherwise was not based upon any particular methodology.  We also publicly disclose the method used to determine the pre-set stock option grant dates and any future changes thereto at least 90 days before they become effective.  All stock option grants, other than initial stock option grants to new employees, will be made at a meeting, whether in-person or telephonic, of the Compensation Committee and not by unanimous written consent, and that the Compensation Committee will determine the grantees, amounts, dates and prices of all stock options and will not delegate these responsibilities.
We have no program, practice or plan to grant stock options to our executive officers, including new executive officers, in coordination with the release of material nonpublic information. We also have not timed the release of material nonpublic information for the purpose of affecting the value of stock options or other compensation to our executive officers, and we have no plan to do so. We have no policy regarding the adjustment or recovery of stock option awards in connection with the restatement of our financial statements, as our stock option awards have not been tied to the achievement of specific financial goals.
CytRx 2017 10-K Page #50#


Tax and Accounting Implications
Deductibility of Executive Compensation
As part of its role, the Compensation Committee reviews and considers the deductibility of executive compensation under Section 162(m) of the Internal Revenue Code, which provides that corporations may not deduct compensation of more than $1,000,000 that is paid to certain individuals. We believe that compensation paid to our executive officers generally is fully deductible for federal income tax purposes.
Accounting for Share-Based Compensation
Beginning on January 1, 2006, we began accounting for share-based compensation in accordance with the requirements of ASC 718, Compensation – Stock Compensation. This accounting treatment has not significantly affected our compensation decisions. The Compensation Committee takes into consideration the tax consequences of compensation to the named executive officers, but tax considerations are not a significant part of the company's compensation policy.
These policies remained in place throughout 2017, and we expect to continue to follow them for the foreseeable future.
Compensation Committee Interlocks and Insider Participation in Compensation Decisions
There are no "interlocks," as defined by the SEC, with respect to any member of the Compensation Committee. Louis Ignarro, Ph.D. and Dr. Brien served as members of the Compensation Committee for all of 2017. Anita Chawla, Ph. D. and Eric Selter served as members of the Compensation Committee in 2017 until July 2017. In July 2017, Joel Caldwell was appointed to the Compensation Committee when he joined the Board. 

Compensation Committee Report
The Compensation Committee has reviewed and discussed with management the "Compensation Discussion and Analysis" required by Item 402(b) of Regulation S-K and, based on such review and discussions, has recommended to our board of directors that the foregoing "Compensation Discussion and Analysis" be included in this Annual Report.
Louis Ignarro, Ph.D.
Chairman
Earl Brien, M.D.
Joel Caldwell, CPA
CytRx 2017 10-K Page #51#



Summary Compensation Table

The following table presents summary information concerning all compensation paid or accrued by us for services rendered in all capacities during 2017, 2016the years ended December 31, 2023 and 20152022 by Steven A. KriegsmanStephen Snowdy and John Y. Caloz, who are the only individuals who served aswere considered our principal executive and financial officers during“Named Executive Officers” for the year ended December 31, 2017;2023.

Summary Compensation Table

Name and Principal Position Year  

Salary

($) (1)

  

Bonus

($) (2)

  

Option

Awards ($)

  

All Other

Compensation ($)

  

Total

($)

 
Stephen Snowdy, Ph.D.                        
Chief Executive Officer  2023   520,000   25,000         545,000 
   2022   488,063   75,000   (3)     563,063 
                         
John Y. Caloz                        
Chief Financial Officer, Treasurer and Senior Vice-President  2023   416,000            416,000 
   2022   400,000   100,000         500,000 

(1)The Named Executive Officers received a 4 percent cost of living adjustment for the 2023 calendar year.

(2)Bonus paid to Dr. Snowdy, the current Chief Executive Officer was paid in January 2023 and was the last quarterly instalment of his 2022 signing bonus; the other three quarterly instalments were paid in the 2022 calendar year; the bonus paid to Mr. Caloz was paid in full in December of 2022.
(3)On January 10, 2022, Dr. Snowdy was granted Stock Appreciation Rights (“SARs”) relating to the appreciation of 3,000 shares of common stock of the Company at an exercise price of $64.00, the fair market value on the date of grant. These SARs vest equally over three years on the annual anniversary of the date of grant.

58

Outstanding Equity Awards at Fiscal Year-End

The following table sets forth outstanding equity awards held by our one other most highly compensated executive officer who was serving as an executive officerNamed Executive Officers as of December 31, 20172023 issued under our 2008 Plan and two former executive officers who would have been our other most highly compensated executive officers as of December 31, 2017 but for the fact that they were not serving as executive officers on that date:

Summary Compensation Table
Name and Principal Position YearSalary ($)  
Bonus
($) (1)
  
Option
Awards
($) (2)
  
All Other
Compensation ($)(3)
  
Total
($)
 
Steven A. Kriegsman               
Chief Executive Officer 2017 850,000   150,000   953,300   13,700   1,967,000 
  2016 850,000   150,000   1,388,750   13,700   2,402,450 
 2015 825,000   150,000   1,593,000   13,700   2,606,700 
John Y. Caloz                    
Chief Financial Officer and Treasurer 2017 400,000   100,000   77,000      577,000 
 2016 400,000   135,000   108,850      643,850 
  2015 375,000   135,000   477,900      987,900 
Daniel Levitt, M.D., Ph.D.                    
Chief Operating Officer and Chief Medical Officer (4) 2017 430,600   702,300         1,132,900 
   2016 625,000   512,500   124,400      1,261,900 
  2015 625,000   150,000   796,500      1,571,500 
                     
Scott Wieland, Ph.D.,                    
Senior Vice President – Drug Development (4) 2017 254,100            254,100 
  2016 400,000   50,000   46,650      496,650 
  2015 400,000   75,000   159,300      634,300 
                     
Felix Kratz, Ph.D.,                    
Vice President – Drug Development                    
  2017 222,400   76,000   33,000      331,400 
  2016 194,500   33,000   31,100      258,600 
  2015 182,000   49,000   119,500      350,500 
2019 Plan:


(1)Bonuses to the named executive officers reported above were paid in December of the applicable year, with the exception of Dr. Levitt, who received a signing bonus in January 2017.
(2)
The values shown in this column represent the aggregate grant date fair value of equity-based awards granted during the fiscal year, inclusive of Mr. Kriegsman's restricted stock award, in accordance with ASC 718, "Share Based-Payment." The fair value of the stock options at the date of grant was estimated using the Black-Scholes option-pricing model, based on the assumptions described in Note 13 of the Notes to Financial Statements included in this Annual Report.
(3)Represents life insurance premiums.

(4)Dr. Levitt and Dr. Wieland resigned in July and June 2017, respectively.
CytRx 2017 10-K Page #52#


2017

Name Number of Securities Underlying Unexercised Options (#) Exercisable  

Number of

Securities

Underlying

Unexercised

Options (#) Unexercisable

  Option Exercise Price ($)  Option Expiration Date Number of Shares or Units of Stock That Have Not Vested (#)  Market Value of Shares or Units of Stock That Have Not Vested ($)  Equity Incentive Plan Awards: Number of Unearned Shares, Units or Other Rights That Have Not Vested (#)  Equity Incentive Plan Awards: Market or Payout Value of Unearned Shares, Units or Other Rights That Have Not Vested ($) 
                        
Stephen Snowdy, Ph.D.                

2,000

  $2,600         
Chief Executive Officer                              
                              
John Y. Caloz  3,500       26.00  12/12/29                
Chief Financial Officer, Treasurer and Senior Vice-President  583       175.00  12/14/27                
   583       258.00  12/14/26                
   500       1,464.00  12/14/25                
   334       1,290.00  12/14/24                

2023 Grants of Plan-Based Awards

In 2017, we granted

No stock options andor restricted stock to our named executive officers underwere granted in 2023.

2008 Stock Incentive Plan and the 2019 Stock Incentive Plan

The purpose of our 2008 Stock Incentive Plan, as follows:

2017 Grants of Plan-Based Awards

Name 
 Grant Date  
All Other
Option Awards
(# of CytRx
Shares)
  
Exercise Price of
Option Awards
($/Share)
  
Grant Date
Fair Value of Stock and
Option Awards
($)
 
Steven A. Kriegsman 12/15/2017   595,931(1)(2) $1.75  $953,300 
Chief Executive Officer               
                
John Y. Caloz 12/15/2017   58,334(1) $1.75  $77,000 
Chief Financial Officer and Treasurer               
                
Daniel Levitt, M.D., Ph.D.            
Executive Vice President and Chief Medical Officer                
                 
Scott Wieland, Ph.D.            
Senior Vice President – Drug Development                
 
Felix Kratz, Ph.D.
  Vice President – Drug Discovery
 12/15/2017   25,000(1) $1.75  $33,000 

___________________________________

(1)Options vest in 36 equal monthly installments, subject to the named executive officer's remaining in our continuous employ through such dates, except in the case of Dr. Kratz, which vest bi-monthly over 24 months, and except that in the case of  Mr. Kriegsman, the unvested options will vest, in full, upon termination of his employment by us without "cause"(the “2008 Plan”), or by reason of his "disability" or by him for "good reason" or upon his death.
(2)Includes the award of 387,597 restricted shares of our common stock which will vest in three equal annual instalments.

2000 Long-Term Incentive Plan and 2008 Stock Incentive Plan
The purpose of our 2000 Long-Term Incentive Plan, or 2000 Plan, and our 20082019 Stock Incentive Plan or(the “2019 Plan”), and together with the 2008 Plan (the “Plans”), is to promote our success and enhance our value by linking the personal interests of our employees, officers, consultants and directors to those of our stockholders. The 2000 Plan was originally adopted by our board of directors on August 24, 2000 and by our stockholders on June 7, 2001, with certain amendments to the Plan having been subsequently approved by our board of directors and stockholders. On May 11, 2009, our board of directors approved an amendment to the 2000 Plan to allow for a one-time stock option re-pricing program for our employees. The 2008 Plan was adopted by our board of directorsBoard on November 21, 2008 and by our stockholders on July 1, 2009 with certain amendments to thatthe 2008 Plan having been subsequently approved by our boardBoard and stockholders. The 2019 Plan was adopted by our Board on November 15, 2019. On September 7, 2023, the Board approved the first amendment (the “Plan Amendment”) to the 2019 Plan, effective as of directorsthe same date. The Plan Amendment amends the 2019 Plan to (i) reflect the Company’s name change from CytRx Corporation to LadRx Corporation in September 2022, and stockholders.
2000(ii) increase the aggregate number of shares of common stock that may be issued under the 2019 Plan, and 2008as set forth in Section 4(a) of the 2019 Plan, Descriptions
The 2000by an additional 75,000 shares of common stock.

2008 Plan and the 20082019 Plan or theDescriptions

The Plans are administered by the Compensation Committee of our board of directors.Board. The Compensation Committee has the power, authority and discretion to:

·designate participants;
·
determine the types of awards to grant to each participant and the number, terms and conditions of any awardaward;
·
establish, adopt or revise any rules and regulations as it may deem necessary or advisable to administer the Plan;Plans; and

59

·make all other decisions and determinations that may be required under, or as the Compensation Committee deems necessary or advisable to administer, the Plan.Plans.
CytRx 2017 10-K Page #53#


Awards under the 20002008 Plan

The 20002008 Plan expired on August 6, 2010,November 20, 2018, and thus no shares are available for future grant under the 20002008 Plan.

Awards under the 20082019 Plan

The following is a summary description of financial instruments that may be granted to participants in our 20082019 Plan by the Compensation Committee of our board of directors. The Compensation Committee to date has only granted stock options to participants in the 2008 Plan.

Board.

Stock Options. The Compensation Committee is authorized to grant both incentive stock options and non-qualified stock options. The terms of any incentive stock option must meet the requirements of Section 422 of the Internal Revenue Code. The exercise price of an option may not be less than the fair market value of the underlying stock on the date of grant, and no option may have a term of more than 10 years from the grant date.

Restricted Stock. The Compensation Committee may make awards of restricted stock, which will be subject to forfeiture to us and other restrictions as the Compensation Committee may impose.

Stock Bonus Awards. The Compensation Committee may make awards of stock bonus awards in consideration for past services actually rendered, which will be subject to repurchase by us and such other terms as the Compensation Committee may impose.

Limitations on Transfer; Beneficiaries. Stock Option awards under the 20082019 Plan may generally not be transferred or assigned by participants other than by will or the laws of descent and distribution. Awards of Restricted Stock or Stock Bonus awards may be transferred or assigned only upon such terms and conditions as set forth in the award agreement or as determined by the Compensation Committee in its discretion.

Acceleration Upon Certain Events. In the event of a "Corporate Transaction"“Corporate Transaction” as defined in the 20082019 Plan, all outstanding options will become fully vested, subject to the holder'sholder’s consent with respect to incentive stock options, and exercisable and all restrictions on all outstanding awards will lapse. Unless the surviving or acquiring entity assumes the awards in the Corporate Transaction or the stock award agreement provides otherwise, the stock awards will terminate if not exercised at or prior to the Corporate Transaction.

Termination and Amendment

Our board of directorsBoard or the Compensation Committee may, at any time and from time to time, terminate or amend the 2000 Plan or the 20082019 Plan without stockholder approval; provided, however, that our boardBoard or the Compensation Committee may condition any amendment on the approval of our stockholders if such approval is necessary or deemed advisable with respect to tax, securities or other applicable laws, policies or regulations. No termination or amendment of the Plans may adversely affect any award previously granted without the written consent of the participants affected. The Compensation Committee may amend any outstanding award without the approval of the participants affected, except that no such amendment may diminish or impair the value of an award.

Holdings of Previously Awarded Equity
Equity awards held as of December 31, 2017 by each of our named executive officers were issued under our 2000 Plan and 2008 Plan. The following table sets forth outstanding equity awards held by our named executive officers as of December 31, 2017:
CytRx 2017 10-K Page #54#


2017 Outstanding Equity Awards at Fiscal Year-End

  Option Awards 
  
Number of
Securities
Underlying
Unexercised
Options
(#)
       
Name 
 Exercisable     Unexercisable  
Option Exercise Price ($)
  
Option Expiration Date
 
 Steven A. Kriegsman     (1)  208,334   1.75  12/14/27 
       President and Chief Executive Officer  129,199   (4)     n/a   n/a 
           69,445   (1)  138,889   2.58  12/14/26 
   111,111   (1)  55,555   14.64  12/14/25 
   100,000   (1)     12.90  12/09/24 
   154,167   (3)     27.96  12/09/23 
   12,363          14.76  3/07/23 
   83,334          10.98  12/10/22 
   23,810          13.02  12/11/21 
   17,858          42.42  12/14/20 
   17,858          44.10  12/10/19 
   7,143          15.54  11/21/18 
   10,715          48.30  4/07/18 
                     
John Y. Caloz     (1)  58,334   1.75  12/14/27 
Chief Financial Officer and Treasurer  19,444   (1)  38,889   2.58  12/14/26 
   33,334   (1)  16,666   14.64  12/14/25 
   33,334          12.90  12/14/24 
   25,000   (3)     27.96  12/09/23 
   16,667          10.98  12/10/22 
   4,762          13.02  12/11/21 
   1,191          42.42  12/14/20 
   2,976          44.10  12/10/19 
   1,191          12.60  01/02/19 
   1,191          15.54  11/21/18 
   595          48.30  04/07/18 
                     
Felix Kratz, Ph.D.                    
Vice-President – Drug Discovery     (2)  25,000   1.75  12/14/27 
   8,333   (2)  8,334   2.58  12/14/26 
   12,500   (2)     14.64  12/09/25 
   10,000          12.90  12/10/24 
   16,667          24.90  3/14/24 

____________
60
(1)
These options vest in 36 equal monthly installments, subject to the named executive officer's remaining in our continuous employ through such dates. All stock options held by Mr. Kriegsman and Dr.
Levitt provide for (a) vesting, in full, of the stock options in the event of, and upon, FDA approval to market aldoxorubicin and in the event of the termination of his employment by us without "cause" or due
to his "disability," his resignation for "good reason" or his death and (b) the extended exercisability for their full term of all vested options in the event of the termination of his employment other than
a termination by us with "cause" or his resignation without "good reason."
(2)These options vest in equal bi-monthly installments, subject to the named executive officer's remaining in our continuous employ through such dates.
(3)The options were re-priced from $14.34 to $27.96 on June 1, 2015, with no change to the expiration date of the options.
(4)Represents restricted stock fully-vested at December 31, 2017. On December 15, 2016, Mr. Kriegsman was granted 387,597 shares of restricted stock, which vest over three years in equal annual amounts.
 


CytRx 2017 10-K Page #55#



Employment Agreements and Potential Payment upon Termination or Change in Control

Employment Agreements with Stephen Snowdy

2022 Snowdy Employment Agreement

On January 3, 2022, the Company entered into an employment agreement, effective January 10, 2022 (the “Effective Date”), with Steven A. Kriegsman

Mr. Kriegsman is employedDr. Stephen Snowdy, under which the Company agreed to employ Dr. Snowdy as ourits Chief Executive Officer pursuantthrough December 31, 2022 (the “Snowdy Employment Agreement”). Pursuant to the Snowdy Employment Agreement, Dr. Snowdy is entitled to a fourth amendment dated asbase annual salary of January 10, 2017 to his fourth amended and restated employment agreement, as amended. The employment agreement will expire on December 31, 2021, but will automatically renew following the expiration date for successive additional one-year periods, unless either Mr. Kriegsman or we elect not to renew it.
Under his employment agreement, Mr. Kriegsman$500,000. Dr. Snowdy also is currently entitled to receive a base salarysigning bonus of $850,000. Our board of directors (or its Compensation Committee) reviews$100,000, payable in four quarterly installments, with the base salary annuallyfirst installment to be paid on the date that is 90 days following the Effective Date, and may increase (but not decrease) itan annual bonus to be determined by the Board in its sole discretion.discretion, based on certain performance criteria as established by the Board, with such bonus payable no later than the last regular payroll in 2022. Dr. Snowdy is also eligible to receive a bonus of up to 3.0% of the amount of non-broker assisted funding raised to fund Centurion on terms acceptable to both the Board of Centurion and LadRx. The Snowdy Employment Agreement also entitles Dr. Snowdy to receive customary benefits and reimbursement for ordinary business expenses. In additionconnection with Dr. Snowdy’s appointment and as a further inducement to enter into the Snowdy Employment Agreement, the Company granted Dr. Snowdy 300,000 cash-based stock appreciation rights with a base price equal to the closing price of the Company’s common stock on the date of grant, subject to the terms and conditions of the Company’s form of cash-based stock appreciation rights agreement, which terms shall include vesting in three substantially equal tranches on the first, second and third anniversary of the Effective Date.

Under the Snowdy Employment Agreement, Dr. Snowdy is also eligible to receive nonqualified stock options equal to 2% of the fully diluted common stock of Centurion with an exercise price equal to the fair market value of Centurion on the date of grant, subject to the terms and conditions of a grant agreement. In the event Dr. Snowdy’s employment is terminated without “cause” or due to “disability” (each term as defined in the Snowdy Employment Agreement) or death, the Company has agreed to (i) pay Dr. Snowdy or his heirs or personal representatives, as applicable, a lump-sum severance amount equal to six months’ base annual salary, Mr. Kriegsmanor twelve months’ base annual salary if Dr. Snowdy’s employment is eligibleterminated without “cause” following a “change in control” (each term as defined in the Snowdy Employment Agreement), and (ii) continue the participation, at the Company’s cost, for a period of six months, or twelve months if the Snowdy Employment Agreement is terminated without “cause” following a “change in control”, of Dr. Snowdy and his dependents in the employee benefits plan in which Dr. Snowdy was participating. In the event Dr. Snowdy’s employment is terminated without “cause”, all of Dr. Snowdy’s vested stock options and any other vested equity awards will remain exercisable for their full term notwithstanding the termination of his employment. In the event Dr. Snowdy’s employment is terminated due to Dr. Snowdy’s “disability” or death, all of Dr. Snowdy’s unvested stock options and other equity awards based on the Company’s securities will immediately vest in full and all of Dr. Snowdy’s stock options and any other equity awards will remain exercisable for their full term notwithstanding the termination of his employment. Dr. Snowdy may also terminate the Employment Agreement for good reason.

2023 Snowdy Employment Agreement

On December 30, 2022, the Company entered into a new employment agreement with Dr. Stephen Snowdy, effective as of January 1, 2023 (the “2023 Snowdy Employment Agreement”), pursuant to which the Company agreed to continue to employ Dr. Snowdy as its Chief Executive Officer through December 31, 2025, unless terminated sooner in accordance with the terms of the 2023 Snowdy Employment Agreement (the “Snowdy Term”). In the event that Dr. Snowdy’s employment has not been terminated and the Company has not offered to extend or renew Dr. Snowdy’s employment under the 2023 Snowdy Employment Agreement upon expiration of the Snowdy Term, in lieu of any other severance benefits as provided in the 2023 Snowdy Employment Agreement, the Company shall continue to pay Dr. Snowdy his salary commencing on the final date of the Snowdy Term and ending on (a) June 30, 2026, or (b) the date of Dr. Snowdy’s re-employment with another employer, whichever is earlier; provided that Dr. Snowdy shall have executed and delivered to the Company a General Release of All Claims. Pursuant to the 2023 Snowdy Employment Agreement, Dr. Snowdy is entitled to receive an annual salary of $520,000, less applicable payroll deductions and tax withholdings. Dr. Snowdy also is eligible for an annual target performance based bonus (the “Snowdy Target Bonus”), equal to 50% of Dr. Snowdy’s annual salary during the Snowdy Term, with such bonus dependent in part on the Company’s performance and the Compensation Committee’s discretion in assessing Dr. Snowdy’s individual performance in relation to his objectives as determined by our boardthe Company’s Board of directors (or its Compensation Committee)Directors and the overall performance and status of the Company, payable no later than February 28th of the calendar year following the calendar year in its sole discretion, but not to be less than $150,000.which the Snowdy Target Bonus relates.

61
Mr. Kriegsman is eligible

The 2023 Snowdy Employment Agreement also entitles Dr. Snowdy to receive grants of options to purchase shares of our common stock. The numbercustomary benefits and terms of those options, including the vesting schedule, will be determined by our board of directors (or its Compensation Committee) in its sole discretion.reimbursement for ordinary business expenses. In his employment agreement, however, we have agreed that all stock options held by Mr. Kriegsman will provide for (a) vesting, in full, of the stock options in the event of, and upon, FDA approvalDr. Snowdy’s employment is terminated without cause, due to market aldoxorubicin and in the event of the termination of Mr. Kriegsman's employment by us without "cause"disability or death, or due to his "disability," his resignation for "good reason"good reason by Dr. Snowdy (each term as defined in the 2023 Snowdy Employment Agreement), the Company has agreed to, among other things, (i) pay Dr. Snowdy or his deathheirs or personal representatives, as applicable, a lump-sum severance amount equal to twelve months’ base annual salary and (b) )an amount equal to the extended exercisability for their full term of all vested options in the eventprorated portion of the Snowdy Target Bonus for the year in which the termination occurred based on the number of his employment by us without "cause," his resignation for "good reason," due to his disabilitydays Dr. Snowdy was employed, or his death.

In Mr. Kriegsman's employment agreement, we have agreed that, if he is made a party, or threatened to be made a party, to a suit or proceeding by reason of his service to us, we will indemnify and hold him harmless from all costs and expenses to the fullest extent permitted or authorized by our certificate of incorporation or bylaws, or any resolution of our board of directors, to the extent not inconsistent with Delaware law. We also have agreed to advance to Mr. Kriegsman such costs and expenses upon his request if he undertakes to repay such advances if it ultimately is determined that he is not entitled to indemnification with respect to the same. These employment agreement provisions are not exclusive of any other rights to indemnification to which Mr. Kriegsman may be entitled and are in addition to any rights he may have under any policy of insurance maintained by us.
If his employment agreement is not renewed by us or by Mr. Kriegsman, or in the event we terminate Mr. Kriegsman's employment without "cause" (as defined), or if Mr. Kriegsman terminates his employment with "good reason" (as defined), in either case whether during or following the term of his employment agreement (i) we have agreed to pay Mr. Kriegsman a lump-suman amount equal to hiseighteen months’ annual salary and prorated minimum annual bonus through to his date of termination, plus his salary and minimum annual bonus for a period of two years (three yearsthe full Snowdy Target Bonus amount if such termination occurs within two yearssix months prior to or within twelve months following a change in control; and (ii) reimburse Dr. Snowdy and his dependents all premiums associated with Dr. Snowdy’s continuation of controlhealth insurance pursuant to the Consolidated Omnibus Budget Reconciliation Act of 1986 (“COBRA”), subject to certain conditions. In the company) after his termination date,event Dr. Snowdy’s employment is terminated without cause or until the expirationby Dr. Snowdy due to good reason, all of the  employment agreement, whichever is later, (ii) he will be entitled to immediate vesting of allDr. Snowdy’s vested stock options or other awards based on our equity securities, and (iii) he will also be entitled to continuation of his life insurance premium payments and continued participation in any of our health plans through to the later of the expiration of the amended and restated employment agreement or  two years (three years if such termination occurs within two years following a change of control) following his termination date. Mr. Kriegsman will have no obligation in such events to seek new employment or offset the severance payments to him by any compensation received from any subsequent reemployment by another employer.
Under Mr. Kriegsman's employment agreement, he and his affiliated company, The Kriegsman Group LLC, are to provide us during the term of his employment with the first opportunity to conduct or take action with respect to any acquisition opportunity or any other potential transaction identified by them within the biotech, pharmaceutical or health care industries and that is within the scope of the business plan adopted by our board of directors. Mr. Kriegsman's employment agreement also contains confidentiality provisions relating to our trade secrets and any other proprietary or confidential information, which provisions shallvested equity awards will remain in effectexercisable for five years after the expiration of the employment agreement with respect to proprietary or confidential information and for so long as our trade secrets remain trade secrets.
CytRx 2017 10-K Page #56#


Potential Payment upon Termination or Change in Control for Steven A. Kriegsman
Mr. Kriegsman's employment agreement contains no provision for payment to him upon the event of a change in control of the company. If, however, a change in control (as defined in our 2000 Plan or our 2008 Plan) occurs and within two years after the date on which the change in control occurs, Mr. Kriegsman's employment is terminated by us without "cause" or by him for "good reason" (each as defined in his employment agreement), in either case, whether during or following thetheir full term of his employment agreement, then, in addition to the severance benefits described above, to the extent that any payment or distribution of any type by us to or for the benefit of Mr. Kriegsman resulting fromnotwithstanding the termination of his employment. In the event Dr. Snowdy’s employment is terminated due to disability or will be subject to the excise tax imposed under Section 4999death, all of the Internal Revenue Code of 1986, as amended, we have agreed to pay Mr. Kriegsman, prior to the time the excise tax is payable with respect to any such payment (through withholding or otherwise), an additional amount that, after the imposition of all income, employment, exciseDr. Snowdy’s unvested stock options and other taxes, penaltiesequity awards based on the Company’s securities will immediately vest in full and interest thereon, is equal toall of Dr. Snowdy’s stock options and any other equity awards will remain exercisable for their full term notwithstanding the sumtermination of (i) the excise tax on such payments plus (ii) any penalty and interest assessments associated with such excise tax.
his employment.

Employment AgreementAgreements with John Y. Caloz

John Y. Caloz is employed as our Chief Financial Officer, Treasurer and TreasurerSenior Vice-President pursuant to an employment agreement (the “Caloz Employment Agreement”) dated as of February 26, 2018December 16, 2021 that is to expireexpired on December 31, 2018.2022. Mr. Caloz is paid an annual base salary of $400,000 and is eligible to receive an annual bonus as determined by our board of directorsBoard (or our Compensation Committee) in its sole discretion.discretion, but not to be less than $100,000. In the event we terminate Mr. Caloz'sCaloz’s employment without cause (as defined)defined in the Caloz Employment Agreement), we have agreed to pay him a lump-sum equal to his accrued but unpaid salary and vacation, plus an amount equal to six months'months’ salary under his employment agreement.

We agree in Mr. Caloz's employment agreement that

Pursuant to the Caloz Employment Agreement, if we dothe Company does not offer to renew or extend his employment agreement,the Caloz Employment Agreement, and that hisMr. Caloz’s employment had not theretofore been terminated, we will continue to pay him his annual salary thereunder during the period commencing upon expiration of his employment agreementthe Caloz Employment Agreement and ending on June 30, 2019.

2023.

2023 Caloz Employment Agreement

On December 30, 2022, the Company entered into a new employment agreement with John Y. Caloz, effective January 1, 2023 (the “2023 Caloz Employment Agreement”), pursuant to which the Company agreed to continue to employ Mr. Caloz as its Chief Financial Officer and Senior Vice President through December 31, 2025, unless terminated sooner in accordance with the 2023 Caloz Employment Agreement (the “Caloz Term”). In the event that Mr. Caloz’s employment has not been terminated and the Company has not offered to extend or renew Mr. Caloz’s employment under the 2023 Caloz Employment Agreement upon expiration of the Caloz Term, in lieu of any other severance benefits as provided in the 2023 Caloz Employment Agreement, the Company shall continue to pay Mr. Caloz his salary commencing on the final date of the Caloz Term and ending on (a) June 30, 2026, or (b) the date of Mr. Caloz’s re-employment with Felix Kratz, Ph.D.

Felix Kratzanother employer, whichever is employed as our Vice President — Drug Discovery pursuantearlier; provided that Mr. Caloz shall have executed and delivered to an employment agreement dated asthe Company a General Release of March 16, 2017 thatAll Claims. Pursuant to the 2023 Caloz Employment Agreement, Mr. Caloz is to expire on March 15, 2018. Dr. Kratz is paid an annual base salary of 185,000 Euros ($222,400) and is eligibleentitled to receive an annual salary of $416,000, less applicable payroll deductions and tax withholdings. Mr. Caloz also is eligible for an annual target performance-based bonus (the “Caloz Target Bonus”), equal to 40% of Mr. Caloz’s annual salary during the Caloz Term, with such bonus dependent in part on the Company’s performance and the Compensation Committee’s discretion in assessing Mr. Caloz’s individual performance in relation to his objectives as determined by our boardthe Board and the overall performance and status of directors (or our Compensation Committee)the Company, payable no later than February 28th of the calendar year following the calendar year in its sole discretion.which the Caloz Target Bonus relates.

The 2023 Caloz Employment Agreement also entitles Mr. Caloz to receive customary benefits and reimbursement for ordinary business expenses. In the event we terminate Dr. Kratz'sMr. Caloz’s employment is terminated without "cause" (as defined)cause, due to disability or death, or due to good reason by Mr. Caloz (each term as defined in the 2023 Caloz Employment Agreement), we havethe Company has agreed to, among other things, (i) pay himMr. Caloz or his heirs or personal representatives, as applicable, a lump-sum severance amount equal to his accrued but unpaidtwelve months’ base annual salary and vacation, plus an amount equal to six months' base salary.

We agreethe prorated portion of the Caloz Target Bonus for the year in Dr. Kratz's employment agreement that if we do not offerwhich the termination occurred based on the number of days Mr. Caloz was employed, or an amount equal to renew or extend his employment agreement, and that his employment had not theretofore been terminated, we will continue to pay him hiseighteen months’ annual salary thereunder duringand the period commencing upon expiration of his employment agreement and ending on September 15, 2019.
CytRx 2017 10-K Page #57#



Quantification of Termination Payments and Benefits
The table below reflects thefull Caloz Target Bonus amount of compensationif such termination occurs within six months prior to each of our named executive officers in the event of termination of such executive's employment without "cause" or his resignation for "good reason," terminationwithin twelve months following a change in controlcontrol; and termination upon the executive's death(ii) reimburse Mr. Caloz and his dependents for all Medicare premiums and premiums associated with Mr. Caloz continuation of permanent disability. The named executive officers are not entitledhealth insurance pursuant to any payments other than accrued compensation and benefits inCOBRA, subject to certain conditions. In the event Mr. Caloz’s employment is terminated without cause or by Mr. Caloz due to good reason, all of Mr. Caloz’s vested stock options and any other vested equity awards will remain exercisable for their voluntary resignation. The amounts shownfull term notwithstanding the termination of his employment. In the event Mr. Caloz’s employment is terminated due to disability or death, all of Mr. Caloz’s unvested stock options and other equity awards based on the Company’s securities will immediately vest in full and all of Mr. Caloz’s stock options and any other equity awards will remain exercisable for their full term notwithstanding the table below assume that such termination was effective as of December 31, 2017, and thus includes amounts earned through such time, and are estimates only of the amounts that would be payable to the executives. The actual amounts to be paid will be determined upon the occurrence of the events indicated.

Termination Payments and Benefits

  Termination w/o Cause or, for Mr. Kriegsman, for Good Reason          
Name 
 Benefit
Before Change in
Control ($)
  
After Change
in
Control ($)
  Death ($)  Disability ($)  
Change in
Control ($)
 
Steven A. Kriegsman Severance Payment (4) 4,250,000   4,250,000   1,700,000   1,700,000    
Chief Executive Officer Stock Options (1)              
  Health Insurance (2) 89,500   134,200   89,500   89,500    
  Life Insurance (2) 27,400   41,100      27,400    
  Bonus 750,000   750,000   300,000   300,000    
  Tax Gross Up (3)              
                     
John Y. Caloz Severance Payment (4) 200,000   400,000          
Chief Financial Officer Stock Options (1)              
  Health Insurance       21,500   21,500    
                     
Felix Kratz, Ph.D. Severance Payment (4) 111,000   222,000          
Vice President, Drug Discovery Stock Options (1)                   
____________
his employment.

 (1)Represents the aggregate value of stock options that vest and become exercisable immediately upon each of the triggering events listed as if such events took place on December 31, 2017, determined by the aggregate difference between the stock price as of December 31, 2017 and the exercise prices of the underlying options.62
(2)Represents the cost as of December 31, 2017 for benefits provided to Mr. Kriegsman for a period of two years, or in the event of a change in control, a period of three years.
(3)Mr. Kriegsman's employment agreement provides that if a change in control (as defined in our 2000 Plan or our 2008 Plan) occurs during the term of the employment agreement, and if, during the term and within two years after the date on which the change in control occurs, Mr. Kriegsman's employment is terminated by us without "cause" or by him for "good reason" (each as defined in their respective employment agreement), then, to the extent that any payment or distribution of any type by us to or for the benefit of Mr. Kriegsman resulting from the termination of his respective employment is or will be subject to the excise tax imposed under Section 4999 of the Internal Revenue Code of 1986, as amended, we will pay Mr. Kriegsman prior to the time the excise tax is payable with respect to any such payment (through withholding or otherwise), an additional amount that, after the imposition of all income, employment, excise and other taxes, penalties and interest thereon, is equal to the sum of (i) the excise tax on such payments plus (ii) any penalty and interest assessments associated with such excise tax. Based on Mr. Kriegsman's past compensation and the estimated payment that would result from a termination of employment following a change in control, we have estimated that a gross-up payment would not be required. "Good reason" as defined in Mr. Kriegsman's employment agreement includes any change in Mr. Kriegsman's duties or title, as applicable, that are inconsistent with his respective positions. Mr. Kriegsman's employment agreement provides that, if the employment agreement is not renewed by us or by Mr. Kriegsman upon the expiration of its term on December 31, 2021, Mr. Kriegsman will be entitled to the termination payments and benefits described above.
(4)Severance payments are prescribed by our employment agreements with the named executive officers and represent a factor of their annual base compensation ranging from six months to two years, except for Mr. Kriegsman, which is the later of December 2021, the expiry of his agreement, or three years.

CytRx 2017 10-K Page #58#


Pay Ratio
  
   
Annual total compensation of the median employee for 2017 $81,000 
Annual total compensation of the CEO for 2017 $1,967,000 
Ratio of annual total compensation of the median employee to the annual total compensation of CEO for 20171:24.3 

The Company chose December 31, 2017 as the date for establishing the employee population used in identifying the median employee and used fiscal 2017 as the measurement period. The Company identified the median employee using a consistently applied compensation measure which includes annual base salary or wages, target annual performance-based cash bonuses, and long-term equity awards based on their grant date fair values. All U.S. and non-U.S. employees employed as of December 31, 2017 were captured. No cost-of-living adjustments were made. The annual total compensation of the median employee and the annual total compensation of the CEO were calculated in accordance with the requirements of Item 402(c)(2)(x) of Regulation S-K.

Compensation of Directors

We use a combination of cash and stock-based compensation to attract and retain qualified candidates to serve on our board of directors.Board. Directors who also are employees of our company currently receive no compensation for their service as directors or as members of board committees. In setting director compensation, we consider the significant amount of time that directors dedicate to the fulfillment of their director responsibilities, as well as the competency and skills required of members of our board. The directors' current compensation schedule has been in place since December 2013. The directors'directors’ annual compensation year begins with the annual election of directors at the annual meeting of stockholders. The annual retainer year period has been in place for directors since 2003. Periodically, our board of directorsBoard reviews our director compensation policies and, from time to time, makes changes to such policies based on various criteria the board deems relevant.

For 2023, the Board implemented an increase of 4 percent in their compensation.

The non-employee director who serves as Chair of the Board receives a quarterly retainer of $6,500. Our non-employee directors receive a quarterly retainer of $6,000$6,240 (plus an additional $5,000$5,200 for the Chairmen of the Audit and Compensation and Strategy Committees, and $1,500 for the Chairman of the Nomination and Governance Committee)Committees), a fee of $3,000$4,160 for each boardBoard meeting attended ($750( or $750 for boardBoard actions taken by unanimous written consent), $2,000 and $3,120 for each meeting of the Audit Committee and Compensation Committee attended, and $1,000$2,600 for each meeting of the Nomination and GovernanceCompensation Committee meeting attended. Non-employee directors who serve as the chairman of a board committee receive an additional $2,000$3,120 for each Audit Committee meeting they chair and an additional $4,160 for each Compensation Committee meeting they chair and the non-employee director who serves as chairperson of the Board receives an additional $4,160 for each meeting of the Nomination and Governance Committee attended and an additional $2,500 for each meeting of the Audit, Compensation or Strategy Committees attended. During 2017, we granted ten-year stock options to purchase 30,000 shares of our common stock to our newly appointed non-employee director, Mr. Joel Caldwell at an exercise price equal to the market value of our common stock on the date of grant. In December 2017, we also granted ten-year stock options to purchase 30,000 shares of our common stock to each non-employee director at an exercise price equal to the market value of our common stock on the date of grant. In addition, Dr. Earl Brien was appointed Chairman of the Strategy Committee, for which he was awarded an additional grant of 40,000 shares. The options vested, in full, upon grant.

CytRx 2017 10-K Page #59#


The following table sets forth the compensation paid to our directors other than our Chief Executive Officer for 2017:

2023:

Director Compensation Table


Name (1) 
 
Fees Earned or Paid in Cash ($) (2)
  
Option Awards ($) (3)
  
   Total
($)
 
Louis Ignarro, Ph.D., Lead Director  135,250   45,600   180,850 
Earl Brien, M.D., Director  97,450   106,400   203,850 
Joel Caldwell, Director  67,300   150,000   217,300 
Eric Selter, Director  42,250      42,250 
Anita Chawla, Ph.D., Director  24,250      24,250 
____________

Name Fees Earned or Paid in Cash ($) (1)  Total ($) 
Cary Claiborne, Director  87,760   87,760 
Joel Caldwell, Director  85,120   85,120 
Jennifer Simpson, Ph.D., Chair of the Board  97,240   97,240 

(1)Steven A. Kriegsman does not receive additional compensation for his role as Chairman of the Board. For information relating to Mr. Kriegsman's compensation as Chief Executive Officer, see the Summary Compensation Table above.

(2)The amounts in this column represent cash payments made to Non-Employee Directors for annual retainer fees, committee and/or chairmanship fees and meeting fees during the year.
(3)          In July 2017, we granted stock options to purchase 30,000 shares of our common stock to newly-appointed non-employee director, Joel Caldwell at an exercise price equal to the current market value of
               our common stock on the date of grant, which had an aggregate grant date fair value respectively of $104,400, and in December 2017, we granted newly-appointed Chairman of the Strategy Committee,
               Dr. Earl Brien stock options to purchase 40,000 shares of our common stock on the date of grant, which had an aggregate grant date fair value respectively of $60,800, both calculated in accordance with
               FASB ASC Topic 718.
        The amount recognized for these awards was calculated using the Black Scholes option-pricing model, and reglect grants from our 2008 Stock Incentive Plan. In December 2017, we granted stock options to purchase 30,000 shares of our common stock to each non-employee director at an exercise price equal to the current market value of our common stock on the date of grant, which had an aggregate grant date fair value of $45,600. The amount recognized for these awards was calculated using the Black Scholes option-pricing model, and reflect grants from our 2008 Stock Incentive Plan, which is described in Note 13 of the Notes to Financial Statements. Eric Selter and Anita Chawla both departed from the Board in July 2017, prior to the annual granting of stock options.
CytRx 2017 10-K Page #60#




Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

Based solely upon information made available to us, the following table sets forth information with respect to the beneficial ownership of our common stock as of March 16, 201827, 2024 by (1) each person who is known by us to beneficially own more than five percent of our common stock; (2) each of our directors; (3) the named executive officersNamed Executive Officers listed in the Summary Compensation Table under Item 11 who were serving as namedNamed Executive Officers as of March 16, 2018;27, 2024; and (4) all of our executive officers and directors as a group. Beneficial ownership is determined in accordance with the SEC rules. Shares of common stock subject to any warrants or options that are presently exercisable, or exercisable within 60 days of March 16, 201827, 2024 (which are indicated by footnote) are deemed outstanding for the purpose of computing the percentage ownership of the person holding the warrants or options, but are not treated as outstanding for the purpose of computing the percentage ownership of any other person. The percentage ownership reflected in the table is based on 28,037,501495,092 shares of our common stock outstanding as of March 16, 2018.27, 2024. Except as otherwise indicated, the holders listed below have sole voting and investment power with respect to all shares of common stock shown, subject to applicable community property laws. An asterisk represents beneficial ownership of less than 1%.

  
Shares of
Common Stock
    
Name of Beneficial Owner 
 Number  Percent    
                      Named Executive Officers and Directors         
Louis Ignarro, Ph.D.  174,212   *   (1)
Steven A. Kriegsman  1,552,819   5.5%  (2)
Joel Caldwell  60,000   *   (3)
Felix Kratz, Ph.D.  54,445   *   (4)
Earl Brien, M.D.  140,247   *   (5)
John Y. Caloz  163,588   *   (6)
All executive officers and directors as a group (six persons)  2,145,312   7.7%  (7)
             
                      5% Beneficial Owners            
NantCell, Inc.  2,469,697   8.8%  (8)
             
             
_______

1)Includes 172,024 shares subject to options or warrants.63
(2)

Name and Address of Beneficial Owner (5) Amount and Nature of Beneficial Ownership (Common Stock)  Percent of Class (Common Stock) 
Named Executive Officers and Directors      
Cary Claiborne  2,778   *(1)
Joel Caldwell  6,132   1.2%(2) 
Jennifer Simpson, Ph.D.  2,803   *(3)
Stephen Snowdy, Ph.D.  13,889   2.7%(4) 
John Y. Caloz  10,689   2.1 %(5) 
All executive officers and directors as a group (five persons)  38,513   2.0 %(6) 

(1)Includes 678,1072,778 shares subject to options or warrants.options.
(3)
(2)Includes 60,0003,378 shares subject to options or warrants.options.
(4)
(3)Includes 54,4452,778 shares subject to options or warrants.options.
(5)
(4)Includes 130,00013,889 shares subject to options or warrants.
(6)
(5)Includes 162,83110,682 shares subject to options or warrants.
(7)
(6)Includes 1,257,40633,505 shares subject to options or warrants.
(7)The address of each of the below listed Named Executive Officers and directors is the Company’s business address located at 11726 San Vicente Blvd, Ste 650, Los Angeles, CA 90049.
(8)Includes 500,000 shares subject to warrants.

Equity Compensation Plans

The information required is incorporated herein by reference to Item 5 of this Annual Report relating to our Equity Compensation Plans as set forth on page 26.

CytRx 2017 10-K Page #61#


38.

Item 13. CERTAIN RELATIONSHIPS, RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE

Director Independence

Our board of directors

Although the Company is no longer listed on The Nasdaq Capital Market, our Board has determined that Messrs. Ignarro, BrienDr. Simpson, Mr. Caldwell and CaldwellMr. Claiborne are "independent"“independent” under the current independence standards of both The NASDAQNasdaq Capital Market and the SEC, and have no material relationships with us (either directly or as a partner, shareholder or officer of any entity) that are inconsistent with a finding of their independence as members of our board of directors.Board. Our boardBoard has determined that Messrs. Ignarro, BrienMr. Claiborne and Mr. Caldwell also are "independent"“independent” for purposes of service as the members of our Audit Committee. In making these determinations, our board of directorsBoard has broadly considered all relevant facts and circumstances, recognizing that material relationships can include commercial, banking, consulting, legal, accounting, and familial relationships, among others.

Transactions with Related Persons

General

Our Audit Committee is responsible for reviewing and approving, as appropriate, all transactions with related persons, in accordance with its Charter and NASDAQ Marketplace Rules.Charter.

64

Transactions between us and one or more related persons may present risks or conflicts of interest or the appearance of conflicts of interest. Our Code of Ethics requires all employees, officers and directors to avoid activities or relationships that conflict, or may be perceived to conflict, with our interests or adversely affect our reputation. It is understood, however, that certain relationships or transactions may arise that would be deemed acceptable and appropriate so long as there is full disclosure of the interest of the related parties in the transaction and review and approval by disinterested directors to ensure there is a legitimate business reason for the transaction and that the transaction is fair to us and our stockholders.

As a result, the procedures followed by the Audit Committee to evaluate transactions with related persons require:

·that all related person transactions, all material terms of the transactions, and all the material facts as to the related person'sperson’s direct or indirect interest in, or relationship to, the related person transaction must be communicated to the Audit Committee; and
·
that all related person transactions, and any material amendment or modification to any related person transaction, be reviewed and approved or ratified by the Audit Committee, as required by NASDAQ MarketplaceOTC Market Rules.

Our Audit Committee will evaluate related person transactions based on:

·information provided by members of our board of directorsBoard in connection with the required annual evaluation of director independence;
·
pertinent responses to the Directors'Directors’ and Officers'Officers’ Questionnaires submitted periodically by our officers and directors and provided to the Audit Committee by our management; and
·background information on nominees for director provided by the Nominating and Corporate Governance Committee of our board of directors; and
·any other relevant information provided by any of our directors or officers.
·
In connection with its review and approval or ratification, if appropriate, of any related person transaction, our Audit Committee is to consider whether the transaction will compromise standards included in our Code of Ethics. In the case of any related person transaction involving an outside director or nominee for director, the Audit Committee also is to consider whether the transaction will compromise the director'sdirector’s status as an independent director as prescribed in the NASDAQ MarketplaceOTC Market Rules.
There were no related person transactions in 2017.
Applicable Definitions
For purposes of our Audit Committee's review:
·"related person" has the meaning given to such term in Item 404(a) of Securities and Exchange Commission Regulation S-K ("Item 404(a)"); and
·"related person transaction" means any transaction for which disclosure is required under the terms of Item 404(a) involving us and any related persons.
CytRx 2017 10-K Page #62#


Item 14. PRINCIPAL ACCOUNTINGACCOUNTANT FEES AND SERVICES

BDO USA, LLP, or BDO, serves

Audit Fees

Weinberg & Company (“Weinberg”), served as our independent registered public accounting firm and audited our consolidated financial statements for the years ended December 31, 20172023 and 2016.

Audit Fees
2022.

The fees for 2017 and 2016the year ended December 31, 2023 from BDOWeinberg for professional services rendered in connection with the auditsaudit of our annual consolidated financial statements and internal controls over financial reporting and reviews of our unaudited quarterlyconsolidated financial statements and Form S-3 registration statements on Form S-1 were $425,210approximately $113,000. The fees for the year ended December 31, 2022 from Weinberg for professional services rendered in connection with the audit of our annual consolidated financial statements and $436,609, respectively.


reviews of our unaudited consolidated financial statements were approximately $125,000.

Audit-Related Fees

None.

Tax Fees

The aggregate fees billed by BDOWeinberg for professional services for tax compliance tax advicewere approximately $23,000 for the year ended December 31, 2023 and tax planning were $17,511 and $45,550approximately $26,000 for 2017 and 2016, respectively.2022.

65

All Other Fees

No other services were rendered by BDOWeinberg in either 2017year ended December 31, 2023 or 2016.

2022.

Pre-Approval Policies and Procedures

It is the policy of our Audit Committee that all services to be provided by our independent registered public accounting firm, including audit services and permitted audit-related and non-audit services, must be pre-approved by our Audit Committee. Our Audit Committee pre-approved all services, audit and non-audit, provided to us by BDOWeinberg for 2017the years ended December 31, 2023 and 2016.

CytRx 2017 10-K Page #63#


2022.

PART IV

Item 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

(a)The following documents are filed as part of this 10-K:

(1)

(1) Financial Statements

Our consolidated financial statements and the related report of the independent registered public accounting firm thereon are set forth on pages F-1 to F-22F-24 of this Annual Report. These consolidated financial statements are as follows:

Consolidated Balance Sheets as of December 31, 20172023 and 2016

2022

Consolidated Statements of Operations for the Years Ended December 31, 2017, 20162023 and 2015

2022

Consolidated Statements of Stockholders'Stockholders’ Equity for the Years Ended December 31, 2017, 20162023 and 2015

2022

Consolidated Statements of Cash Flows for the Years Ended December 31, 2017, 20162023 and 2015

20221

Notes to Consolidated Financial Statements

Reports of Independent Registered Public Accounting Firm

(2)

(2) Financial Statement Schedule

The following financial statement schedule is set forth on page F-24 of this Annual Report.
Schedule II — Valuation and Qualifying Accounts for the years ended December 31, 2017, 2016 and 2015
Schedules

All other schedules are omitted because they are not required, not applicable, or the information is provided in the consolidated financial statements or notes thereto.

(b)

(3) Exhibits

See Exhibit Index to this Annual Report, which is incorporated herein by reference.

66
CytRx 2017 10-K Page #64#


CytRx

LadRx Corporation

Form 10-K Exhibit Index

    Incorporated By Reference to

Exhibit

Number

 Description Form Exhibit Filing Date 

Filed / Furnished

Herewith

2.1 Agreement and Plan of Merger, dated as of June 6, 2008, among CytRx Corporation, CytRx Merger Subsidiary, Inc., Innovive Pharmaceuticals, Inc., and Steven Kelly 8-K 2.1 6/9/2008  
3.1 Restated Certificate of Incorporation of CytRx Corporation, as amended 10-K 3.1 3/13/2012  
3.2 Certificate of Amendment of Restated Certificate of Incorporation 8-K 3.1 5/15/2012  
3.3 Certificate of Amendment of Restated Certificate of Incorporation 8-K 3.1 11/1/2017  
3.4 Certificate of Amendment of Restated Certificate of Incorporation 8-K 3.1 3/16/2022  
3.5 Certificate of Elimination of Designation of Series A Junior Participating Preferred Stock 8-K 3.2 12/19/2019  
3.6 Certificate of Elimination of Series B Convertible Preferred Stock 8-K 3.3 12/19/2019  
3.7 Amended and Restated Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock 8-K 3.1 11/17/2020  
3.8 Amended and Restated By-Laws of CytRx Corporation, effective November 12, 2020 and Amendment No. 1 to the Amended and Restated Bylaws of dated May 19, 2022. 8-K 3.3 5/19/2022  
3.9 Certificate of the Designations, Powers, Preferences and Rights of Series C 10.00% Convertible Preferred Stock 8-K 3.1 7/15/2021  
3.10 Certificate of Amendment of Restated Certificate of Incorporation 8-K 3.1 3/16/2022  
3.11 Certificate of Correction to the Certificate of Amendment of Restated Certificate of Incorporation 8-K 3.3 5/19/2022  
3.12 Certificate of Designation of Series D Preferred Stock 8-K 3.1 5/19/2022  
3.13 Certificate of Amendment of Restated Certificate of Incorporation 8-K 3.1 9/23/2022  
3.14 Certificate of Amendment of Restated Certificate of Incorporation 8-K 3.1 5/11/2023  
3.15 Certificate of Amendment of Restated Certificate of Incorporation 8-K 3.1  9/11/2023   
3.16 Amendments to the By-Laws 8-K 3.2 9/11/2023  
4.1 Amended and Restated Rights Agreement, dated as of November 16, 2020, by and between CytRx Corporation and American Stock Transfer & Trust Company, LLC, as rights agent 8-K 4.1 11/17/2020  
4.2 Form of Preferred Investment Option 8-K 4.1 7/15/2021  
10.1+ CytRx Corporation Amended and Restated 2008 Stock Incentive Plan 10-K 10.6 3/13/2012  
10.1.2+ Eighth Amendment to Amended and Restated CytRx Corporation 2008 Stock Incentive Plan 

14A

(proxy)

 Annex B 5/20/2016  
10.1.3+ Form of Non-qualified Stock Option for grants to non-employee directors under Amended and Restated 2008 Stock Incentive Plan. 10-K 10.11 3/11/2016  
10.1.4+ Form of Non-qualified Stock Option for grants to executive officers under Amended and Restated 2008 Stock Incentive Plan . 10-K 10.12 3/11/2016  

    Incorporated By Reference to  

Exhibit

Number

 Description Form Exhibit Filing Date 

Filed / Furnished

Herewith

10.3.2 Fifth Amendment to Office Lease dated January 13, 2020 by and between CytRx Corporation and Douglas Emmett 1993, LLC 10-K 10.3.2 3/24/2021  
10.4.1 Amendment dated March 14, 2014 to License Agreement between CytRx Corporation and KTB Tumorforschungs GmbH 8-K 1.1 3/17/2014  
10.5 Asset Purchase Agreement dated May 13, 2011 between CytRx Corporation and Orphazyme ApS 10-Q 10.1 5/17/2011  
10.6 Exclusive License Agreement, dated as of July 27, 2017, by and between CytRx Corporation and NantCell, Inc. 8-K 10.1 8/1/2017  
10.8+ Employment Agreement, dated December 16, 2021, by and between CytRx Corporation and John Y. Caloz 10-K 10.8 3/23/2022  
10.9 CytRx Corporation 2019 Stock Incentive Plan 8-K 10.1 11/15/2019  
10.10 Form of Securities Purchase Agreement, dated as of July 13, 2021, by and between the Company and the purchaser thereto 8-K 10.1 7/15/2021  
10.11 Form of Registration Rights Agreement, dated as of July 13, 2021, by and between the Company and the purchaser thereto 8-K 10.2 7/15/2021  
10.12 Amendment No. 1 to the Cooperation Agreement, dated September 2, 2021, by and between CytRx Corporation and Jerald A. Hammann 8-K 10.1 9/9/2021  
10.13+ Employment Agreement, dated January 3, 2022, by and between CytRx Corporation and Dr. Stephen Snowdy 8-K 10.1 1/4/2022  
10.14+ General Release and Separation Agreement, dated January 3, 2022, by and between CytRx Corporation and Steven A. Kriegsman. 8-K 10.2 1/4/2022  
10.15+ Employment Agreement, dated December 30, 2022, by and between LadRx Corporation and Dr. Stephen Snowdy.       **
10.16+ Employment Agreement, dated December 30, 2022, by and between LadRx Corporation and John Y. Caloz       **
10.17 Royalty Purchase Agreement dated June 21, 2023, by and between LadRx Corporation and XOMA (US) LLC 8-K 10.1 6/26/2023  
10.18# Assignment and Assumption Agreement, dated June 21, 2023, by and between LadRx Corporation and XOMA (US) LLC 8-K 10.2 6/26/2023  
10.19 Amendment No. 1 to LadRx Corporation 2019 Stock Incentive Plan 8-K 10.1 9/11/2023  
23.1 Consent of Weinberg & Company       **

  Incorporated By Reference to 
Exhibit
Number
Description
 
Form
 
Exhibit
Filing Date
Filed / Furnished
Herewith
2.1Agreement and Plan of Merger, dated as of June 6, 2008, among CytRx Corporation, CytRx Merger Subsidiary, Inc., Innovive Pharmaceuticals, Inc., and Steven Kelly8-K2.16/9/2008 
3.1Restated Certificate of Incorporation of CytRx Corporation, as amended10-K3.13/13/2012 
3.2Certificate of Amendment of Restated Certificate of Incorporation8-K3.15/15/2012 
3.3Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock, Pursuant to Section 151 of the Delaware General Corporation Law8-K3.112/14/2016 
3.4Certificate of Amendment of Restated Certificate of Incorporation8-K3.111/1/2017 
3.5Restated By-Laws of CytRx Corporation, as amended8-K3.27/16/2013 
4.1Shareholder Protection Rights Agreement dated April 16, 1997 between CytRx Corporation and American Stock Transfer &Trust Company, as Rights Agent8-K99.14/17/1997 
4.1.1Amendment No. 1 to Shareholder Protection Rights Agreement, dated February 11, 200210-K4.24/1/2002 
4.1.2Amendment No. 2 to Shareholder Protection Rights Agreement, dated March 30, 200710-K4.34/2/2007 
4.1.3Amendment No. 3 to Shareholder Protection Rights Agreement, dated July 12, 201610-Q4.111/9/2016 
      
4.2Common Stock Purchase Warrant issued by CytRx Corporation to Alexander Capital, L.P.10-K4.53/11/2016 
4.3Form of Common Stock Purchase Warrant issued by CytRx Corporation, dated July 20, 201610-K4.63/15/2017 
4.4Contingent Common Stock Purchase Warrant Agreement dated as of December 5, 2016 issued by CytRx Corporation to Bristol Capital Advisors, LLC on February 10, 201710-K4.73/15/2017 
4.5Warrant Agreement dated as of February 5, 2016 issued by CytRx Corporation to Hercules Technology Growth Capital, LLC8-K10.22/9/2016 
4.5.1First Amendment to Warrant Agreement, dated July 28, 2017, issued by CytRx Corporation to Hercules Capital, Inc. 8-K10.58/1/2017 
4.6Warrant Agreement dated as of February 5, 2016 issued by CytRx Corporation to Hercules Technology III, L.P.8-K10.32/9/2016 
4.6.1First Amendment to Warrant Agreement, dated July 28, 2017, issued by CytRx Corporation to Hercules Technology III, L.P. 8-K10.68/1/2017 
4.7Warrant, dated as of July 27, 2017, issued by CytRx Corporation to NantCell, Inc. 8-K10.38/1/2017 
CytRx 2017 10-K Page #65#


  Incorporated By Reference to 
Exhibit
Number
Description
 
Form
 
Exhibit
Filing Date
Filed / Furnished
Herewith
10.1.1*Amendment No. 2 to CytRx Corporation 2000 Long-Term Incentive Plan14A (proxy)Annex C6/11/2002 
10.1.2*Amendment No. 3 to CytRx Corporation 2000 Long-Term Incentive Plan10-K10.145/14/2004 
10.1.3*Amendment No. 4 to CytRx Corporation 2000 Long-Term Incentive Plan10-K10.155/14/2004 
10.2*CytRx Corporation Amended and Restated 2008 Stock Incentive Plan10-K10.63/13/2012 
10.2.1*Sixth Amendment to Amended and Restated CytRx Corporation 2008 Stock Incentive Plan
14A
(proxy)
Annex B5/5/2015 
10.2.2*Seventh Amendment to Amended and Restated CytRx Corporation 2008 Stock Incentive Plan
14A
(proxy)
Annex A5/20/2016 
10.2.3*Eighth Amendment to Amended and Restated CytRx Corporation 2008 Stock Incentive Plan
14A
(proxy)
Annex B5/20/2016 
10.2.4*Form of Non-qualified Stock Option for grants to non-employee directors under Amended and Restated 2008 Stock Incentive Plan.10-K10.113/11/2016 
10.2.5*Form of Non-qualified Stock Option for grants to executive officers under Amended and Restated 2008 Stock Incentive Plan.10-K10.123/11/2016 
10.3*Form of Non-qualified Stock Option for grants to Steven A. Kriegsman and Daniel J. Levitt, M.D., Ph.D., under Amended and Restated 2008 Stock Incentive Plan.10-K10.133/11/2016 
10.3.1*Amendment No. 1 to Stock Option Agreements of Daniel J. Levitt, M.D., Ph.D., dated December 31, 2015.10-K10.143/11/2016 
10.3.2*Amendment No. 1 to Stock Option Agreements (2000 Long-Term Incentive Plan) of Steven A. Kriegsman, dated March 8, 2016.10-K10.153/11/2016 
10.3.3*Amendment No. 1 to Stock Option Agreements (2008 Stock Incentive Plan) of Steven A. Kriegsman, dated March 8, 201610-K10.163/11/2016 
10.4†License Agreement, dated December 7, 2001, by and between CytRx Corporation and Vical Incorporated8-K9912/21/2001 
10.5Office Lease between The Kriegsman Capital Group, LLC and Douglas Emmett Joint Venture, dated April 13, 200010-K10.635/14/2004 
10.5.1Assignment, Assumption and Consent, effective July 1, 2003, by and among CytRx Corporation, The Kriegsman Capital Group, LLC and Douglas Emmett Joint Venture, concerning Office Lease dated April 13, 200010-K10.645/14/2004 
10.5.2First Amendment to Office Lease dated October 14, 2005, by and between CytRx Corporation and Douglas Emmett 1993, LLC8-K10.110/20/2005 
 10.5.3Second Amendment to Office Lease dated June 30, 2008, by and between CytRx Corporation and Douglas Emmett 1993, LLC 10-K 10.29 3/13/2009 
 10.5.4Third Amendment to Office Lease dated December 1, 2009, by and between CytRx Corporation and Douglas Emmett 1993, LLC10-Q  10.1 12/4/2009 
 10.5.5Fourth Amendment to Office Lease dated February 10 2014, by and between CytRx Corporation and Douglas Emmett 1993, LLC8-K  10.1 2/13/2014 

CytRx 2017 10-K Page #66#


     Incorporated By Reference to 
 
Exhibit
Number
 Description Form Exhibit Filing Date Filed/Furnished Herewith
10.6†License Agreement dated April 17, 2006 between Innovive Pharmaceuticals, Inc. and KTB Tumorforschungs GmbH10-Q10.1511/14/2006 
10.6.1Amendment dated March 14, 2014 to License Agreement between CytRx Corporation and KTB Tumorforschungs GmbH8-K1.13/17/2014 
10.7*Employment Agreement dated January 1, 2017, between CytRx Corporation and Daniel J. Levitt, M.D., Ph.D.10-K10.263/15/2017 
10.8*Employment Agreement dated January 1, 2017, between CytRx Corporation and Scott Wieland10-K10.293/15/2017 
10.9*Employment Agreement dated January 10, 2017, between CytRx Corporation and John Y. Caloz10-K10.303/15/2017 
10.10*Employment Agreement dated February 26, 2018, between CytRx Corporation and John Y. Caloz   **
10.11*Fourth Amended and Restated Employment Agreement, dated May 10, 2012, by and between CytRx Corporation and Steven A. Kriegsman8-K10.110/19/2012 
10.11.1*First Amendment to Fourth Amended and Restated Employment Agreement by and between CytRx Corporation and Steven A. Kriegsman, dated March 4, 201410-K10.323/5/2014 
10.11.2*Second Amendment to Fourth Amended and Restated Employment Agreement by and between CytRx Corporation and Steven A. Kriegsman, dated January 1, 201510-K10.313/10/2015 
10.11.3*Third Amendment to Fourth Amended and Restated Employment Agreement by and between CytRx Corporation and Steven A. Kriegsman, dated March 8, 201610-K10.363/11/2016 
10.11.4*Fourth Amendment to Fourth Amended and Restated Employment Agreement by and between CytRx Corporation and Steven A. Kriegsman dated January 10, 201710-K10.383/15/2017 
10.12*Restricted Stock Purchase Agreement by and between CytRx Corporation and Steven A. Kriegsman, dated January 11, 201710-K10.393/15/2017 
10.13*Restricted Stock Purchase Agreement by and between CytRx Corporation and Steven A. Kriegsman, dated January 30, 2018   **
10.14Loan and Security Agreement dated February 5, 2016 among CytRx Corporation, the Lender referred to therein, and Hercules Technology Growth Capital, Inc., as Agent8-K10.12/9/2016 
10.14.1First Amendment to Loan and Security Agreement, dated July 28, 2017, among CytRx Corporation, the lenders parties thereto, and Hercules Capital, Inc., as collateral agent for itself and the lenders 8-K10.48/1/2017 
10.15†Exclusive License Agreement, dated as of July 27, 2017, by and between CytRx Corporation and NantCell, Inc. 8-K10.18/1/2017 
10.16Stock Purchase Agreement, dated as of July 27, 2017, by and between CytRx Corporation and NantCell, Inc. 8-K10.28/1/2017 
23.1Consent of BDO USA, LLP   **
31.1Certification of Chief Executive Officer Pursuant to 15 U.S.C. Section 7241, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002   **
31.2Certification of Chief Financial Officer Pursuant to 15 U.S.C. Section 7241, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002   **
32.1Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002   ***
32.2Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002   ***
CytRx 2017 10-K Page #67#


68
 

Incorporated By Reference to

Exhibit

Number

Description  FormDescriptionExhibit FormExhibitFiling Date Filed/

Filed / Furnished

Herewith

101.INS++31.1Certification of Chief Executive Officer Pursuant to 15 U.S.C. Section 7241, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002**
31.2Certification of Chief Financial Officer Pursuant to 15 U.S.C. Section 7241, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002**
32.1Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002***
32.2Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002***
101.INSInline XBRL Instance Document.**
101.SCH++101.SCHInline XBRL Taxonomy Extension Schema Document.**
101.CAL++101.CALInline XBRL Taxonomy Extension Calculation Linkbase Document.**
101.DEF++101.DEFInline XBRL Taxonomy Extension Definition Linkbase Document.**
101.LAB++101.LABInline XBRL Taxonomy Extension Label Linkbase Document.**
101.PRE++101.PREInline XBRL Taxonomy Extension Presentation Linkbase Document.**
104Cover Page Interactive Data File (formatted as Inline XBRL)
______________

*Indicates a management contract or compensatory plan or arrangement.
**Filed herewith.
***Furnished herewith.
+Management contract or compensatory plan or arrangement
Confidential treatment has been requested or granted for certain portions which have been blanked out in the copy of the exhibit filed with the Securities and Exchange Commission.SEC. The omitted information has been filed separately with the SEC.
#Certain of the schedules (and similar attachments) to this Exhibit have been omitted in accordance with Regulation S-K Item 601(a)(5) of Regulation S-K under the Securities Act because they do not contain information material to an investment or voting decision and Exchange Commission.that information is not otherwise disclosed in the Exhibit or the disclosure document. The registrant hereby agrees to furnish a copy of all omitted schedules (or similar attachments) to the SEC upon its request.

Item 16. FORM 10-K SUMMARY

None.

69
++Pursuant to applicable securities laws and regulations, the Registrant is deemed to have complied with the reporting obligation relating to the submission of interactive data files in such exhibits and is not subject to liability under any anti-fraud provisions of the federal securities laws as long as the Registrant has made a good faith attempt to comply with the submission requirements and promptly amends the interactive data files after becoming aware that the interactive data files fails to comply with the submission requirements. These interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and otherwise are not subject to liability under these sections.

Item 16. SUMMARY

None
CytRx 2017 10-K Page #68#


SIGNATURES

In accordance with Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Company NameLADRX CORPORATION
Date: March 16, 201827, 2024By:/s/ STEVEN A. KRIEGSMANSTEPHEN SNOWDY
Steven A. Kriegsman
Chairman and

Dr. Stephen Snowdy

Chief Executive Officer

(Principal Executive Officer)

By:/s/ JOHN Y. CALOZ
John Y. Caloz
Chief Financial Officer (Principal Financial and Accounting Officer)

In accordance with the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant in the capacities and on the dates indicated.

SignatureTitleTitleDate
/s/ STEVEN A. KRIEGSMANSTEPHEN SNOWDY
Chairman of the Board and
Chief Executive Officer
March 16, 201827, 2024
 Steven A. Kriegsman
Stephen Snowdy, Ph.D.
 (Principal(Principal Executive Officer)
/s/ JOHN Y. CALOZ
Chief Financial OfficerMarch 16, 201827, 2024
John Y. Caloz(Principal Financial and Accounting Officer)

/s/ LOUIS IGNARRO

CARY CLAIBORNE

Director

Director

March 16, 201827, 2024

Louis Ignarro, Ph.D.Cary Claiborne
/s/ JENNIFER SIMPSONDirector and Chair of the BoardMarch 27, 2024
/s/ EARL BRIEN
Jennifer Simpson, Ph.D.
DirectorMarch 16, 2018
EARL Brien, M.D.

/s/ JOEL CALDWELL
DirectorDirectorMarch 16, 201827, 2024
Joel Caldwell

70
 

CytRx 2017 10-K Page #69#


INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

AND FINANCIAL STATEMENT SCHEDULE


CytRxLadRx Corporation
ReportReports of Independent Registered Public Accounting Firm (PCAOB ID No. 572)F-1F- 2
Consolidated Balance SheetsF-2F- 3
Consolidated Statements of OperationsF-3F- 4
Consolidated Statements of Stockholders'Stockholders’ Equity (Deficit)F-4F- 5
Consolidated Statements of Cash FlowsF-5F- 6
Notes to Consolidated Financial StatementsF-6F- 7

Financial Statement Schedule II — Valuation and Qualifying AccountsF-1F-22
 

CytRx 2017 10-K Page # F-iii#


Report of Independent Registered Public Accounting Firm


Board of Directors and Stockholders

CytRx

LadRx Corporation

Los Angeles, California

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated balance sheets of CytRxLadRx Corporation (the "Company"“Company”) and subsidiary as of December 31, 20172023 and 2016,2022, the related consolidated statements of operations, stockholders'stockholders’ equity (deficit), and cash flows for each of the three years in the periodthen ended, December 31, 2017, and the related notes and the financial statement schedule of valuation and qualifying accounts (collectively referred to as the "financial statements"“consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company atand its subsidiary as of December 31, 20172023 and 2016,2022, and the results of theirits operations and theirits cash flows for each of the three years in the periodthen ended, December 31, 2017, in conformity with accounting principles generally accepted in the United States of America.

We also

Going Concern

The accompanying consolidated financial statements have audited,been prepared assuming that the Company will continue as a going concern. As discussed in accordance withNote 1 to the standardsconsolidated financial statements, the Company has no recurring source of the Public Company Accounting Oversight Board (United States) ("PCAOB"), the Company's internal control over financial reporting as ofrevenue, has incurred recurring operating losses and negative operating cash flows since inception and has an accumulated deficit at December 31, 2017, based on criteria established2023. These matters raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in Internal Control – Integrated Framework (2013) issued byregard to these matters are also described in Note 1 to the Committeeconsolidated financial statements. These consolidated financial statements do not include any adjustments that might result from the outcome of Sponsoring Organizations of the Treadway Commission ("COSO") and our report dated March 16, 2018 expressed an unqualified opinion thereon.

this uncertainty.

Basis for Opinion

These consolidated financial statements are the responsibility of the Company'sCompany’s management. Our responsibility is to express an opinion on the Company'sCompany’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB"(“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.

The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.




/s/ BDO USA, LLP

Critical Audit Matter

Sale of Royalty Interest

As described in Note X, on June 21, 2023, the Company, entered into a royalty purchase agreement for the sale, transfer, assignment and conveyance of the company’s right, title and interest in and to certain royalty payments and milestone payments with respect to a certain license agreement. The combined aggregate purchase price paid to the company for this transaction was $5 million, less certain transaction fees and expenses, resulting in net proceeds to the company of $4.1 million. Management determined that the Royalty Agreement should be accounted for within the scope of ASC 610-20. As such, the Company recognized such net proceeds as other income in the accompanying statement of operations.

The principal consideration for our determination that the accounting for this transaction as a critical audit matter is due to the complexity of underlying transaction including the significant judgements made by management in determining the appropriate accounting. This in turn required a high degree of auditor judgement and led to significant effort in performing our audit procedures which were designed to evaluate the propriety of the Company’s accounting and disclosure of this transaction.

Our audit procedures performed to address this critical audit matter included, among others, (1) gaining an understanding of the process used by management to evaluate the accounting for this transaction and assessing the reasonableness of this evaluation, (ii) examining transaction-related documents, (iii) testing to ensure completion of all performance related obligations of the company related to this transaction, (iv) and testing the completeness and accuracy of the company’s disclosure and financial statement presentation of this transaction.

We have served as the Company'sCompany’s auditor since 2004.

2019.

Weinberg & Company

Los Angeles, California

March 27, 2024

F-2
March 16, 2018
CytRx 2017 10-K Page # F-1#




CYTRX

LADRX CORPORATION

CONSOLIDATED BALANCE SHEETS


  December 31, 
  2017  2016 
ASSETS      
Current assets:      
Cash and cash equivalents $37,643,404  $56,959,485 
Receivables  7,529,032   183,703 
Prepaid expenses and other current assets  1,914,077   3,434,238 
Total current assets  47,086,513   60,577,426 
Equipment and furnishings, net  1,042,892   1,959,667 
Goodwill  183,780   183,780 
Other assets  34,334   48,911 
 Total assets $48,347,519  $62,769,784 
LIABILITIES AND STOCKHOLDERS' EQUITY        
Current liabilities:        
Accounts payable $4,122,017  $6,406,445 
Accrued expenses and other current liabilities  8,029,274   3,830,498 
Deferred revenue  6,924,353    
Term loan, net - current  10,599,795   5,481,656 
Warrant liabilities  527,025   3,789,391 
Total current liabilities  30,202,464   19,507,990 
         
Long term loan, net     18,484,510 
Total liabilities  30,202,464   37,992,500 
Commitment and contingencies
 
        
Stockholders' equity (2016 restated to reflect a 1-6 reverse stock split, see Note 1):        
Preferred Stock, $0.01 par value, 833,334 shares authorized, including 4,167 shares of Series A Junior Participating Preferred Stock; no shares issued and outstanding      
Preferred Stock, $0.01 par value, stated value $1,000, 650 shares authorized of Series B Convertible Preferred Shares at $2.52 per share, 550 issued, 0 outstanding at December 31, 2017, 518 outstanding at December 31, 2016.     518,000 
Common stock, $0.001 par value, 41,666,667 shares authorized; 28,037,501 and 18,553,817 shares issued and outstanding at December 31, 2017 and 2016, respectively  28,037   18,553 
Additional paid-in capital  468,969,445   440,106,726 
Accumulated deficit  (450,852,427)  (415,865,995)
Total stockholders' equity  18,145,055   24,777,284 
Total liabilities and stockholders' equity $48,347,519  $62,769,784 

       
  December 31, 
  2023  2022 
       
ASSETS        
Current assets:        
Cash and cash equivalents $2,070,075  $1,374,992 
Prepaid expenses and other current assets  191,783   628,745 
Total current assets  2,261,858   2,003,737 
Equipment and furnishings, net  6,711   18,546 
Other assets  7,703   7,703 
Operating lease right-of-use assets  31,610   216,786 
Total assets $2,307,882  $2,246,772 
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)        
Current liabilities:        
Accounts payable $1,202,689  $975,944 
Accrued expenses and other current liabilities  964,233   1,015,501 
Current portion of operating lease obligations  33,606   196,081 
Total current liabilities  2,200,528   2,187,526 
         
Operating lease liabilities, net of current portion     33,526 
         
Total liabilities  2,200,528   2,221,052 
         
Preferred Stock, Series C 10% Convertible, $1,000 par value, 0 and 2,752 shares issued and outstanding at December 31, 2023 and 2022, respectively     1,343,684 
         
Commitments and contingencies  -   - 
Stockholders’ equity (deficit):        
Preferred Stock, $0.01 par value, 833,333 shares authorized, including 50,000 shares of Series B Junior Participating Preferred Stock; no shares issued and outstanding at December 31, 2023 and 2022, respectively      
Common stock, $0.001 par value, 62,393,940 shares authorized; 495,092 and 450,374 shares issued and outstanding at December 31, 2023 and 2022, respectively  495   450 
Additional paid-in capital  488,612,890   487,519,251 
Accumulated deficit  (488,506,031)  (488,837,665)
Total stockholders’ equity (deficit)  107,354   (1,317,964)
Total liabilities and stockholders’ equity (deficit) $2,307,882  $2,246,772 

The accompanying notes are an integral part of these consolidated financial statements.

F-3
CytRx 2017 10-K Page # F-2#


CYTRX

LADRX CORPORATION

CONSOLIDATED STATEMENTS OF OPERATIONS


  Years Ended December 31, 
  2017  2016  2015 
Revenue:         
Licensing revenue $100,000  $200,000  $100,000 
             
Expenses:            
Research and development  19,840,106   35,930,212   43,395,574 
General and administrative  12,502,042   15,990,789   19,664,904 
Depreciation and amortization  629,312   536,631   317,649 
   32,971,460   52,457,632   63,378,127 
Loss before other income (expense)  (32,871,460)  (52,257,632)  (63,278,127)
Other income (expense):            
Interest income  365,584   255,123   233,958 
Interest expense  (3,831,211)  (2,754,677)   
Other income (expense), net  (16,322)  159,148   20,151 
Gain on warrant liabilities  1,367,777   3,827,617   4,437,628 
             
Loss before provision for income taxes  (34,985,632)  (50,770,421)  (58,586,390)
Provision for income taxes  (800)  (800)  (800)
Net loss $(34,986,432) $(50,771,221) $(58,587,190)
 
Basic and diluted loss per share
 $(1.46) $(3.78) $(5.82)
Basic and diluted weighted average shares outstanding  24,042,293   13,510,629   10,080,526 

  2023  2022 
  Years Ended December 31, 
  2023  2022 
Revenue:      
Licensing revenue $  $ 
         
Expenses:        
General and administrative  3,532,302   4,545,884 
Research and development  279,489    
Depreciation and amortization  11,835   15,004 
Total operating expenses  3,823,626   4,560,888 
Loss from operations  (3,823,626)  (4,560,888)
Other income (expense):        
Forgiveness of accounts payable     351,241 
Interest income  55,434   11,689 
Sale of royalty and milestone rights, net of transaction costs  4,167,219    
Other income (expense), net  1,416   (2,615)
         
Net Income (Loss)  400,443   (4,200,573)
         
Dividends paid on preferred shares  (68,809)  (561,381)
         
Net income (loss) attributable to common stockholders $331,634   (4,761,954)
Basic and diluted income (loss) per share $0.68  $(0.11)
Basic and diluted weighted average shares outstanding  488,392   450,374 

The accompanying notes are an integral part of these consolidated financial statements.

F-4
CytRx 2017 10-K Page # F-3#


CYTRX

LADRX CORPORATION

CONSOLIDATED STATEMENTS OF STOCKHOLDERS'STOCKHOLDERS’ EQUITY


  Series B Preferred Shares Issued  Common Shares Issued  Preferred Stock Amount  Common Stock Amount  
Additional
Paid-in
Capital
  Accumulated Deficit  Treasury Stock  Total 
Balance at January 1, 2015     9,320,331  $  $9,321  $377,022,587  $(306,507,584) $(2,612,861) $67,911,463 
Issuance of stock options/warrants for compensation and services  
      
      7,384,656         7,384,656 
Common stock issued in connection with a public offering  
   1,744,167   
   1,744   26,778,324         26,780,068 
Options and warrants exercised  
   48,726   
   48   589,953         590,001 
Retirement of treasury stock  
   (33,213)  
   (33)  (2,612,828)     2,612,861    
Net loss  
      
         (58,587,190)     (58,587,190)
Balance at December 31, 2015  
   11,080,011       11,080   409,162,692   (365,094,774)     44,078,998 
Issuance of stock options/warrants for compensation and services  
      
      6,735,576         6,735,576 
Stock issued in connection with a public offering  
550
   6,685,362   
550,000
   6,685   25,220,572         25,777,257 
Warrants issued in connection with a public offering  
      
      (6,923,551)        (6,923,551)
Preferred stock conversion  (32)  76,191   (32,000)  76   31,924          
Issuance of restricted stock grant  
   387,597   
   388   1,937         2,325 
Warrants issued in connection with term loan  
      
      633,749         633,749 
Beneficial conversion feature – Series B preferred stock  
      (314,286)     314,286          
Series B preferred stock deemed dividend  
      
314,286
      (314,286)         
Options and warrants exercised  
   64,393   
   64   744,087         744,151 
Class action settlement share issuance  
   260,263   
   260   4,499,740          4,500,000 
Net loss                 (50,771,221)     (50,771,221)
Balance at December 31, 2016  
518
   18,553,817   518,000   18,553   440,106,726   (415,865,995)     24,777,284 
Options and warrants exercised  
   880,788   
   881   3,012,779         3,013,660 
Stock issued in connection with a public offering  
   5,000,000   
   5,000   13,946,218         13,951,218 
Preferred stock conversion  (518)  1,233,334   (518,000)  1,233   516,767          
Issuance of restricted stock grant  
   387,597   
   388            388 
Warrants repriced to term loan lender  
      
      76,549         76,549 
Shares issued in connection with licensing sale  
   1,969,697   
   1,970   6,073,677         6,075,647 
1 – 6 reverse stock split fractional shares  
   12,268   
   12   (12)         
Issuance of stock options/warrants for compensation and services  
      
      3,344,520         3,344,520 
Warrant liability exercises  
      
      1,894,589         1,894,589 
Banking fee on warrant exercises  
      
      (2,368)        (2,368)
Net loss                 (34,986,432)     (34,986,432)
Balance at December 31, 2017  
   28,037,501  $  $28,037  $468,969,445  $(450,852,427) $  $18,145,055 

(DEFICIT)

  Series B Preferred Shares Issued  Shares of Common Stock Issued  Preferred Stock Amount  Common Stock Amount  Additional Paid-in Capital  Accumulated Deficit  Total 
Balance at January 1, 2022     387,800     $388   484,829,042  $(484,075,711) $753,719 
Issuance of common stock upon conversion of preferred shares     62,360      62   2,678,954      2,679,016 
Exercise of stock options     214                
Issuance of restricted stock for compensation and services                  11,255       11,255 
Preferred dividend                 (561,381)  (561,381)
Net loss                  (4,200,573)  (4,200,573)
Balance at December 31, 2022     450,374      450   487,519,251   (488,837,665)  (1,317,964)
Balance     450,374      450   487,519,251   (488,837,665)  (1,317,964)

Increase in fractional shares upon reverse stock split      13,191       13   (13)       
Preferred dividend                      (68,809)  (68,809)
Issuance of common stock upon conversion of preferred shares     31,277             31   1,343,653      1,343,684 
Issuance of common stock     250      1   (1)      
Payment to redeem investment option              (250,000)        (250,000)
Net income                 400,443   400,443 
Net income (loss)                 400,443   400,443 
Balance at December 31, 2023     495,092            $495  $488,612,890  $(488,506,031) $107,354 
Balance     495,092            $495  $488,612,890  $(488,506,031) $107,354 

The accompanying notes are an integral part of these consolidated financial statements.

F-5
CytRx 2017 10-K Page # F-4#


CYTRX

LADRX CORPORATION

CONSOLIDATED STATEMENTS OF CASH FLOWS


  Years Ended December 31, 
  2017  2016  2015 
Cash flows from operating activities:         
Net loss $(34,986,432) $(50,771,221) $(58,587,190)
Adjustments to reconcile net loss to net cash used in operating activities:            
Depreciation and amortization  629,312   536,631   317,649 
Loss on retirement of equipment and furnishings  424,049   12,276   2,614 
Gain on warrant liabilities  (1,367,777)  (3,827,617)  (4,437,628)
Amortization of loan cost and discount  1,923,816   587,837    
Stock-based compensation expense  3,344,520   6,735,576   7,384,656 
Non-cash litigation settlement due in common stock        4,500,000 
Changes in assets and liabilities:            
Receivable  (7,344,941)  4,412,097   (2,574,182)
Interest receivable     28,130   76,497 
Prepaid expenses and other current assets  1,534,738   (28,569)  1,118,931 
Accounts payable  (2,286,416)  (1,672,631)  916,919 
Deferred revenue  6,924,353       
Accrued expenses and other current liabilities  4,007,210   (5,862,861)  3,699,287 
Net cash used in operating activities  (27,197,568)  (49,850,352)  (47,582,447)
             
Cash flows from investing activities:            
Proceeds from matured short-term investments     35,035,420   76,544,319 
 Purchase of short-term investments        (65,958,146)
Purchases of equipment and furnishings  (134,598)  (1,020,441)  (331,328)
Net cash provided by (used in) investing activities  (134,598)  34,014,979   10,254,845 
             
Cash flows from financing activities:            
Proceeds from common stock issued in public offering, net of fees  13,951,218   25,777,257   26,780,068 
Proceeds from term loan, net     24,012,078    
Proceeds from sale of common shares and warrants related to NantCell  6,075,647       
Loan amendment fee payment  (200,000)      
Term loan principal repayment  (15,013,638)      
Net proceeds from exercise of stock options and warrants  3,202,858   744,151   590,001 
Net cash provided by financing activities  8,016,085   50,533,486   27,370,069 
             
Net increase (decrease) in cash and cash equivalents  (19,316,081)  34,698,113   (9,957,533)
Cash and cash equivalents at beginning of year  56,959,485   22,261,372   32,218,905 
Cash and cash equivalents at end of year $37,643,404  $56,959,485  $22,261,372 
             
Supplemental disclosures of non-cash financing/investing activities:            
Warrant liability exercises $1,894,589  $  $3 
Warrants repriced in connection with the sale of licenses $76,549  $  $ 
Receivable from issuance of restricted stock $388  $2,325  $ 
Equipment and furnishings purchased but not paid $1,988  $20,452  $485,743 
Retirement of treasury stock    $  $2,612,861 
Warrants issued in connection with the term loan $  $633,749  $ 
1 – 6 reverse stock split $12  $4,500,000  $ 
Series B Preferred stock beneficial conversion feature and deemed dividend $  $314,286  $ 
Warrants issued/amended in connection with the public offering $  $6,923,551  $ 
Series B Preferred stock conversion $1,233  $457  $ 
             
Supplemental disclosure of Cash Flow Information:            
Cash paid during the year for income taxes $800  $800  $800 
Cash paid during the year for interest $2,025,468  $1,959,375  $ 
             

  2023  2022 
  Years Ended December 31, 
  2023  2022 
Cash flows from operating activities:        
Net income (loss) from operations $400,443  $(4,200,573)
         
Adjustments to reconcile net income (loss) to net cash used in operating activities:        
Depreciation and amortization  11,834   15,004 
Stock-based compensation expense     11,255 
Changes in assets and liabilities:        
Insurance receivable     200,000 
Prepaid expenses and other current assets  436,961   681,637 
Reduction of right of-use assets  185,176   180,306 
Accounts payable  226,745   (494,708)
Other assets     9,133 
Decrease in lease liabilities  (196,002)  (185,593)
Accrued expenses and other current liabilities  (51,265)  (1,049,005)
Net cash provided by (used in) operating activities  1,013,892   (4,832,464)
         
Cash flows from investing activities:        
Purchases of equipment and furnishings     (766)
Net cash used in investing activities     (766)
         
Cash flows from financing activities:        
Purchase of Investment Option  (250,000)   
Preferred stock dividend  (68,809)  (561,381)
Net cash used in financing activities  (318,809)  (561,381)
         
Net increase (decrease) in cash and cash equivalents  695,083   (5,394,611)
Cash and cash equivalents at beginning of year  1,374,992   6,769,603 
Cash and cash equivalents at end of year $2,070,075  $1,374,992 
         
Supplemental disclosures of Cash Flow Information:        
Non-cash investing and financing activities        
Issuance of common stock upon conversion of preferred shares $1,343,684  $2,679,016 

The accompanying notes are an integral part of these consolidated financial statements.

F-6
CytRx 2017 10-K Page # F-5#


CYTRX

LADRX CORPORATION

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

FOR THE YEARS ENDED DECEMBER 31, 2023 AND 2022

1. Nature of Business

CytRx

LadRx Corporation ("CytRx"(“LadRx” or "the Company")the Company) is a biopharmaceutical research and development company specializing in oncology. OurThe Company’s focus is on the discovery, research and clinical development of novel anti-cancer drug candidates that employ novel linker technologies that target chemotherapeutic drugs to enhancesolid tumors and reduce off-target toxicities. During 2017, the accumulation and release of cytotoxic anti-cancer agents at the tumor.  CytRx has an active drugCompany’s discovery and research operation at its laboratory facilities in Freiburg, Germany.

The LADR™ (Linker Activated Drug Release) technology platform is a discovery engine combining CytRx's expertise in linker chemistry and albumin biology to create a pipeline of anti-cancer molecules that will avoid unacceptable systemic toxicity while delivering highly potent agents directly to the tumor.  The Company has created a "toolbox" of linker technologies that have the ability to significantly increase the therapeutic index of ultra-high potency drugs (10-1,000 times more potent than traditional chemotherapies) by controlling the release of the drug payloads and improving drug-like properties. After infusion, these ultra-high potency drug conjugates bind to circulating albumin for transport of the drug to the tumor.  Subsequently, due to specific conditions within the tumor, the linkers are cleaved and release the anti-cancer drug payload.

CytRx's current efforts are focused on two classes of ultra-high potency drug conjugates.  The Company's strategy across these programs is to generate additional pre-clinical data that will allow them to make informed decisions regarding the selection of one or both programs for moving into human clinical trials either independently or on a partnered basis.

During 2017, CytRx's discovery laboratoryGermany synthesized and tested over 75 rationally designed drug conjugatescandidates with highly potent cytotoxicanti-cancer payloads, andculminating in the creation of two distinct classes of compounds have been created.  To date, fourcompounds. Four lead candidates have been(LADR 7 through LADR-10) were selected based on in vitroand animal preclinical studies in several different cancer models, and based on stability and manufacturing feasibility. Additional animal efficacyIn addition, a novel companion diagnostic, ACDx™, was developed to identify patients with cancer who are most likely to benefit from treatment with these drug candidates.

On June 1, 2018, the Company launched Centurion BioPharma Corporation (“Centurion”), a wholly-owned private subsidiary, and toxicology testingtransferred to Centurion all of these lead candidates is underway.

On July 27, 2017, CytRxits assets, liabilities and personnel associated with the laboratory operations in Freiburg, Germany. In connection with said transfer, the Company and Centurion entered into an exclusive worldwide license with NantCell, Inc. ("NantCell"), grantinga Management Services Agreement whereby the Company agreed to NantCellrender advisory, consulting, financial and administrative services to Centurion, for which Centurion shall reimburse the exclusive rights to develop, manufactureCompany for the cost of such services plus a 5% service charge. On December 21, 2018, LadRx announced that Centurion had concluded the pre-clinical phase of development for its four LADR™ (Linker Activated Drug Release) drug candidates, and commercialize aldoxorubicinfor its albumin companion diagnostic (ACDx™). As a result of completing this work, operations taking place at the pre-clinical laboratory in all indications, and it isFreiburg, Germany were no longer directly working on developmentneeded and, accordingly, the lab was closed at the end of aldoxorubicin.  As partJanuary 2019.

On March 9, 2022, Centurion merged with and into LadRx, with LadRx absorbing all of Centurion’s assets and continuing after the merger as the surviving entity (the “Merger”). The Merger was implemented through an agreement and plan of merger pursuant to Section 253 of the license, NantCell madeGeneral Corporation Law of the State of Delaware and did not require approval from either our or Centurion’s stockholders. The Certificate of Ownership merging Centurion into LadRx was filed with the Secretary of State of Delaware on March 9, 2022.

Effective September 26, 2022, the Company changed its name from CytRx Corporation to LadRx Corporation pursuant to a strategic investmentCertificate of $13 million in CytRx common stock at $6.60 per share (adjustedAmendment to reflectour Certificate of Incorporation filed with the Secretary of State of Delaware. In accordance with the General Corporation Law of the State of Delaware (the “DGCL”), its 2017board of directors approved the name change and the Certificate of Amendment. Pursuant to Section 242(b)(1) of the DGCL, stockholder approval was not required for the name change or the Certificate of Amendment.

2023 Reverse Stock Split

The Company effected a 1-for-100 reverse stock split), a premiumsplit (the “Reverse Stock Split”) of 92% to the market price on that date. CytRx alsoits issued NantCell a warrant to purchase up to 500,000and outstanding shares of common stock at $6.60 over the following 18 months.  The Company is entitledon May 17, 2023, pursuant to receive up to an aggregate of $343 million in potential milestone payments, contingent upon achievement of certain regulatory approvals and commercial milestones.  CytRx is also entitled to receive ascending double-digit royalties for net sales for soft tissue sarcomas and mid to high single digit royalties for other indications.


Aldoxorubicin is a conjugatewhich every 100 shares of the commonly prescribed chemotherapeutic agent doxorubicin that binds to circulating albumin in the bloodstreamCompany’s issued and is believed to concentrate the drug at the site of the tumor. Aldoxorubicin, the Company's lead clinical candidate, has been tested in over 600 patients with various types of cancer. Specifically, it is comprised of (6-maleimidocaproyl) hydrazine, an acid-sensitive molecule that is conjugated to doxorubicin.  The initial indication for aldoxorubicin is for patients with advanced soft tissue sarcomas (STS).
Aldoxorubicin has received Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of STS. ODD provides several benefits including seven years of market exclusivity after approval, certain R&D related tax credits, and protocol assistance by the FDA.  European regulators granted aldoxorubicin Orphan designation for STS which confers ten years of market exclusivity among other benefits.

In the first quarter of 2018, CytRx announced that NantCell was expanding aldoxorubicin' s use by combining it with immunotherapies and cell based treatments, specifically in metastatic pancreatic cancer and in advanced squamous cell carcinoma of the head and neck or non-small cell lung cancer.
CytRx 2017 10-K Page # F-6#



Currently, the Company's only research and development activities are at its laboratory facilities in Freiburg, Germany. For this reason and others, its operating expenses are expected to be significantly lower in the near future. Therefore, period to period comparisons should not be relied upon as predictive of the results in future periods.

At December 31, 2017, the Company had cash and cash equivalents of approximately $37.6 million. Under the terms of the loan agreement, however, the Company is required to maintain cash equal to a minimum of the greater of three months projected cash burn or $10 million. Management believes that its current resources will be sufficient to fund its operations for the foreseeable future. This estimate is based, in part, upon the Company's currently projected expenditures for 2018 and the first three months of 2019 of approximately $27.8 million (unaudited), which includes approximately $1.5 million (unaudited) for its clinical programs, approximately $3.1 million (unaudited) for pre-clinical development of new high potency cytotoxic albumin-binding cancer drugs, approximately $0.7 million (unaudited) for general operation of its clinical programs, approximately $10.1 million (unaudited) for other general and administrative expenses and $12.4 million of interest and principal payments on our outstanding term loan. These projected expenditures are also based upon numerous other assumptions and subject to many uncertainties, and actual expenditures may be significantly different from these projections. While these projections represent the Company's current expected expenditures, the Company has the ability to reduce the amounts and alter the timing of research and development expenditures as needed to manage its liquidity needs while still advancing its research and development objectives. The Company will ultimately be required to obtain additional funding in order to execute its long-term business plans, although it does not currently have commitments from any third parties to provide it with long term debt or capital. The Company cannot assure that additional funding will be available on favorable terms, or at all. If the Company fails to obtain additional funding when needed, it may not be able to execute its business plans and its business may suffer, which would have a material adverse effect on its financial position, results of operations and cash flows.
Effective November 1, 2017, the Company completed a 1-for-6 reverse stock split of the Company's outstanding shares of common and preferred stock reduced its authorized shareswere converted into one share of both common and preferred stock by one-sixth; nowithout any change was madein the par value per share. Any fraction of a share of common stock that would otherwise have resulted from the Reverse Stock Split were rounded up to the per-share par value of the common stock.nearest whole share. All share and per share amounts in the accompanying financial statementsthis Annual Report have been adjusted to reflect the reverse stock split as if it had occurred at the beginning of the earliest period presented.

Corporate Information

LadRx is a Delaware corporation, incorporated in 1985. Our corporate offices are located at 11726 San Vicente Boulevard, Suite 650, Los Angeles, California 90049, and our telephone number is (310) 826-5648. Our web site is located at http://www.ladrxcorp.com. We do not incorporate by reference into this Annual Report the information on, or accessible through, our website, and you should not consider it as part of this Annual Report.

F-7

Going Concern

The Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. During the year ended December 31, 2023, although we realized a net income of $0.4 million, we had a loss from operations of $3.8 million, and incurred a net loss of $4.2 million for the year ended December 31, 2022, and had total stockholders’ equity as of December 31, 2023 of $0.1 million. The Company has no recurring revenue, and we are likely to continue to incur losses unless and until we conclude a successful strategic partnership or financing for our LADR™ technology. As a result, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern. The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

In order to fund our business and operations, we have relied primarily upon sales of our equity securities, including proceeds from the exercise of stock options and common stock purchase warrants and long-term loan financing. We also have received limited funding from our strategic partners and licensees. We will ultimately be required to obtain additional funding in order to execute our long-term business plans, although we do not currently have commitments from any third parties to provide us with long-term debt or capital. We cannot assure that additional funding will be available on favorable terms, or at all. If we fail to obtain additional funding when needed, we may not be able to execute our business plans and our business may suffer, which would have a material adverse effect on our financial position, results of operations and cash flows. We have approximately $1.0 million of contractual obligations in 2024 and expect to pay these out of the Company’s balance sheet cash. We have a total of approximately $1.0 million of material contractual obligations beyond 2023.

We have no commitments from third parties to provide us with any additional financing, and we may not be able to obtain future financing on favorable terms, or at all. Failure to obtain adequate financing would adversely affect our ability to operate as a going concern. If we raise additional funds by issuing equity securities, dilution to stockholders may result and new investors could have rights superior to some or all of our existing equity holders. In addition, debt financing, if available, may include restrictive covenants. If adequate funds are not available to us, we may have to liquidate some or all of our assets or to delay or reduce the scope of or eliminate some portion or all of our development programs or clinical trials.

2. Summary of Significant Accounting Policies

Basis of Presentation and Principles of Consolidation — The accompanying Consolidated Financial Statements are prepared pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC"(“SEC”) and accounting principles generally accepted in the United States ("GAAP"(“GAAP”).

The Consolidated Financial Statements include the accounts of LadRx Corporation and its wholly-owned subsidiary. All intercompany accounts are eliminated.

Revenue Recognition— Revenue consists of license fees from strategic alliances with pharmaceutical companies.

Since 2011, During the Company has followed the Financial Accounting Standards Board ("FASB") Accounting Standards Codifications ("ASC") ASC 605-25, Revenue Recognition – Multiple-Element Arrangements ("ASC 605-25" to determine the recognition ofyears ended December 31, 2023 and 2022, no revenue underwas earned from license and collaboration agreements. The ASC provides guidance relating to the separation of deliverables including an arrangement into different units of accounting and the allocation of consideration to the units of accounting. The allocated consideration for each unit of accounting is recognized over the related obligation period in accordance with the applicable revenue recognition criteria. Revenue is considered realizable and earned when the following criteria are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the price is fixed or determinable; and (4) collection of the amounts due are reasonably assured. Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue in the Company's balance sheets. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current liabilities.
Other Income (Expense) — The Company realized a small foreign exchange loss in 2017, other income of $0.2 million in 2016 from a VAT refund, and a de minimus amount of other income in 2015.
fees.

Cash Equivalents— The Company considers all highly liquid debt instruments with an original maturity of 90 days or less to be cash equivalents. Cash equivalents consist primarily of amounts invested in certificates of deposit and money market accounts.

Equipment and Furnishings— Equipment and furnishings are stated at cost and depreciated using the straight-line method based on the estimated useful lives (generally three to five years for equipment and furniture) of the related assets. Whenever there is a triggering event that might suggest impairment, management evaluates the realizability of recorded long-lived assets to determine whether their carrying values have been impaired. The Company records impairment losses on long-lived assets used in operations when events and circumstances indicate that the assets might be impaired and the non-discounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. Any impairment loss is measured by comparing the fair value of the asset to its carrying amount. There are no impairment losses recognized in each of 2017, 2016 and 2015.

F-8
CytRx 2017 10-K Page # F-7#


Fair Value Measurements — Assets and liabilities recorded at fair value on the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure the fair value. Level inputs are as follows:

Level 1 – quoted prices in active markets for identical assets or liabilities.

Level 2 – other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement date.

Level 3 – significant unobservable inputs that reflect management's best estimate of what market participants would use to price the assets or liabilities at the measurement date.

The following table summarizes fair value measurements by level at December 31, 2017 for assets and liabilities measured
at fair value on a recurring basis:

(In thousands) Level I  Level II  Level III  Total 
Cash equivalents $35,834  $  $  $35,834 
Warrant liabilities        (527)  (527)

The following table summarizes fair value measurements by level at December 31, 2016 for assets and liabilities measured
at fair value on a recurring basis:

(In thousands) Level I  Level II  Level III  Total 
Cash equivalents $56,276  $  $  $56,276 
Warrant liabilities        (3,789)  (3,789)

There were no transfers between Levels I, II and III during 2017 or 2016.
The changes in carrying amounts of the warrant liability for the years ended December 31, 2017 and 2016 were as follows:
(In thousands) 2017  2016 
Beginning balance $3,789  $693 
Issued     6,933 
Exercised  (1,895)  (9)
Net changes in valuation  (1,367)  (3,828)
Ending balance $527  $3,789
 
Liabilities measured at fair market value on a recurring basis include warrant liabilities resulting from recent debt and equity financing. In accordance with ASC 815-40, Derivatives and Hedging – Contracts in Entity's Own Equity ("ASC 815-40"), the warrant liabilities are being marked to fair value each quarter-end until they are completely settled. The warrants are valued using the Black-Scholes method, using assumptions consistent with the Company's application of ASC 505-50, Equity-Based Payments to Non-Employees ("ASC 505-50"). See Warrant Liabilities below.
The Company considers carrying amounts of accounts receivable, accounts payable, accrued expenses and term loan, net to approximate fair value due to the short-term nature of these financial instruments.

Patents and Patent Application Costs— Although the Company believes that its patents and underlying technology have continuing value, the amount of future benefits to be derived from the patents is uncertain. Patent costs are therefore expensed as incurred.

CytRx 2017 10-K Page # F-8#


Net Income (Loss) Per Share of Common Share Stock— Basic net income (loss) per common share is computed using the weighted-average number of common shares outstanding. Dilutedby dividing net income (loss) by the weighted average number of shares of common stock outstanding for the period. Diluted earnings per common share is computed by dividing the net income applicable to common stockholders by the weighted average number of shares of common stock outstanding plus the number of additional shares of common stock that would have been outstanding if all dilutive potential shares of common stock had been issued using the weighted-average numbertreasury stock method. Potential shares of common stock are excluded from the computation when their effect is antidilutive. The dilutive effect of potentially dilutive securities is reflected in diluted net income per share andif the exercise prices were lower than the average fair market value of common share equivalents outstanding. stock during the reporting period.

Schedule of Share Excluded from Computation of Diluted Loss Per Share

  2023  2022 
  As of December 31, 
  2023  2022 
    
Options to acquire common stock  14,000   18,477 
Warrants to acquire common stock  42   42 
Convertible preferred stock     31,272 
Preferred investment option     113,637 
Share excluded from computation of diluted loss per shares  14,042   163,428 

Potentially dilutive stock options, warrants and warrants to purchase approximately 7.6 million, 8.3 million and 3.6 million shares at December 31, 2017, 2016 and 2015, respectively,securities from the table above were excluded from the computation of diluted net income (loss) per share, because the effect would be anti-dilutive.

Warrant Liabilities

Stock-based CompensationLiabilities measured at fair value on a recurring basis include warrant liabilities resulting from the Company's July 2016 equity financings. In The Company accounts for share-based awards to employees and nonemployees directors and consultants in accordance with ASC 815-40, the warrant liabilities are being marked to fair value each quarter-end until they are completely settled. The warrants are valued using the Black-Scholes method, using assumptions consistent with CytRx's application of ASC 505-50. The gain or loss resulting from the fair value calculation is shown on the Statements of Operations as gain (loss) on warrant liabilities. See "Note 10 – Warrant Liabilities" for additional information related to the determination of fair value of warrants.

Stock-based Compensation — The Company's stock-based employee compensation plans are described in Note 13. The Company has adopted the provisions of ASC 718, which requiresCompensation—Stock Compensation., and under the recently issued guidance following FASB’s pronouncement, ASU 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. Under ASC 718, and applicable updates adopted, share-based awards are valued at fair value measurementon the date of grant and recognition of compensation expense for all stock-based awards made to employees.
For stock options and stock warrants paid in consideration of services rendered by non-employees, the Company recognizes compensation expense in accordance with the requirements of ASC 505-50, Equity ("ASC 505"), as amended. Non-employee option grants that do not vest immediately upon grant are recorded as an expensefair value is recognized over the requisite service, or vesting, period. At the end of each financial reporting period prior to performance, the value of these options, as calculatedThe Company values its equity awards using the Black-Scholes option-pricingoption pricing model, is determined, and compensation expense recognized or recovered during the period is adjusted accordingly. Since the fair market value of options granted to non-employees is subject to change in the future, the amount of the future compensation expense is subject to adjustment until the common stock options or warrants are fully vested.
accounts for forfeitures when they occur.

Research and Development Expenses— Research and development expenses consist of costs incurred for direct and overhead-related research expenses and are expensed as incurred. Costs to acquire technologies, including licenses and drugs, that are utilized in research and development and that have no alternative future use are expensed when incurred. Technology developed for use in its products is expensed as incurred until technological feasibility has been established.

F-9
Clinical Trial Expenses — Clinical trial expenses, which are included in research and development expenses, include obligations resulting from the Company's contracts with various clinical research organizations in connection with conducting clinical trials for its product candidates. The Company recognizes expenses for these activities based on a variety of factors, including actual and estimated labor hours, clinical site initiation activities, patient enrollment rates, estimates of external costs and other activity-based factors. The Company believes that this method best approximates the efforts expended on a clinical trial with the expenses it records. The Company adjusts its rate of clinical expense recognition if actual results differ from its estimates. If its estimates are incorrect, clinical trial expenses recorded in any particular period could vary. Non-refundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made.

Income Taxes— The Company accounts for income taxes in accordance with the provisions of FASB ASC 740-10, Income Taxes, ("(“ASC 740"740”) which requires the recognition of deferred tax assets and liabilities for taxable temporary differences and deferred tax assets for deductible temporary differences and operating loss carry-forwards using enacted tax rates in effect in the years the differences are expected to reverse. Deferred income tax benefit or expense is recognized as a result of changes in net deferred tax assets or deferred tax liabilities. A valuation allowance is recorded when it is more likely than not that some or all of any deferred tax assets will not be realized.

On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (the 2017 Tax Act) was enacted reducing the corporate tax rate from 35% to 21% which is effective on January 1, 2018. The carrying value of the Company's deferred tax assets is also determined by the enacted U.S. corporate income tax rate. Consequently, any changes in the U.S. corporate income tax rate have impacted the carrying value of the Company's deferred tax assets. Under the new corporate income tax rate of 21%, deferred income taxes decreased but there is a corresponding decrease to the valuation allowance. Therefore, the 2017 Tax Act is expected to have no impact on the Company's 2017 earnings. In accordance with Staff Accounting Bulletin No. 118, as of December 31, 2017, the Company has not completed its accounting for the tax effects of the enactment of the 2017 Tax Act; however, the Company has made a reasonable estimate of the effects on its existing deferred tax balances.
CytRx 2017 10-K Page # F-9#


The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by the taxing authorities based on the technical merits of the position. The Company'sCompany’s policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expenses.

Concentrations of Risks— Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of cash, cash equivalents and short-term investments. The Company maintains cash and cash equivalents in large well-capitalized financial institutions and the Company'sCompany’s investment policy disallows investment in any debt securities rated less than "investment-grade"“investment-grade” by national ratings services. The Company has not experienced any losses on its deposits of cash or cash equivalents or its short-term investments. Cash and cash equivalents are maintained at financial institutions and, at times, balances may exceed federally insured limits. The Company has never experienced any losses related to these balances.

Use of EstimatesThe preparationPreparation of the Company’s consolidated financial statements in conformityconformance with accounting principles generally accepted inU.S. GAAP requires the United States of America requiresCompany’s management to make estimates and assumptions that affectimpact the reported amounts reportedof assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. SignificantThe significant estimates includein the accrual for research and development expenses,Company’s consolidated financial statements relate to the valuation onof equity awards, recoverability of deferred tax assets, contingent liabilitiesinsurance claims and estimated useful lives of fixed assets. The Company bases estimates and assumptions on historical experience, when available, and on various factors that it believes to be reasonable under the estimate of expense arising from the common stock optionscircumstances. The Company evaluates its estimates and warrants granted to employeesassumptions on an ongoing basis, and non-employees. Actualits actual results could materiallymay differ from those estimates.

Recentestimates made under different assumptions or conditions.

New Accounting PronouncementsIn January 2017,The Company’s management has evaluated all the recently issued, but not yet effective, accounting standards and guidance that have been issued or proposed by the FASB issued an ASU entitled "Intangibles - Goodwillor other standards-setting bodies through the filing date of these financial statements and Other (Topic 350): Simplifying the Test for Goodwill Impairment." The objective of the ASU is to simplify how an entity is required to test goodwill for impairment by eliminating Step 2 from the goodwill impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit's goodwill with the carrying amount of that goodwill. This ASU is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. Early adoption is permitted. The Company does not believe that the future adoption of this guidanceany such pronouncements will have a material impact on its financial statements.


In August 2016, the Financial Accounting Standards Board issued ASU No. 2016-15 "Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (a consensus of the Emerging Issues Task Force)." The objective of ASU No. 2016-15 is to provide specific guidance on eight cash flow classification issues and how to reduce diversity in how certain cash receipts and cash payments are presented and classified in the statement of cash flows under Topic 230, Statement of Cash Flows, and other Topics. The amendments in this update are effective for public business entities for fiscal years beginning after December 15, 2017 and interim periods within those fiscal years. The Company is still in the process of determining the impact that the implementation of ASU 2016-15 will have on its financial statements.

In March 2016, the FASB issued Accounting Standards Update 2016-09, Compensation—Stock Compensation ("ASU 2016-09"). ASU 2016-09 includes several areas of simplification to stock compensation including simplifications to the accounting for income taxes, classification of excess tax benefits on the Statement of Cash Flows and forfeitures. ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016. The Company adopted this Standard on January 1, 2017. The adoption of this Standard did not have a material impact to the Company's financial position or its results of operations.
In February 2016, the FASB issued ASU No. 2016-02, "Leases (Topic 842)," which requires companies to recognize all leases as assets and liabilities on the consolidated balance sheet. This ASU retains a distinction between finance leases and operating leases, and the classification criteria for distinguishing between finance leases and operating leases are substantially similar to the classification criteria for distinguishing between capital leases and operating leases in the current accounting literature. The result of retaining a distinction between finance leases and operating leases is that under the lessee accounting model in Topic 842, the effect of leases in a statement of operations and a statement of cash flows is largely unchanged from previous GAAP.  The amendments in this ASU are effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Earlier adoption is permitted. Although the Company has not finalized its process of evaluating the impact of adoption of the ASU on its financial statements, the Company expects there will not be a material increase to assets and liabilities on the Company's balance sheet for leases currently classified as operating leases.
In January 2016, the FASB issued ASU No. 2016-01 "Financial Instruments-Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities." ASU 2016-01 amends various aspects of the recognition, measurement, presentation, and disclosure for financial instruments. With respect to the Company's financial statements, the most significant impact relates to the accounting for equity investments. It will impact the disclosure and presentation of financial assets and liabilities. ASU 2016-01 is effective for annual reporting periods, and interim periods within those years beginning after December 15, 2017. Early adoption by public entities is permitted only for certain provisions. The Company does not believe that the adoption of this guidancewill have a material impact on its financial statements.
CytRx 2017 10-K Page # F-10#


In November 2015, the FASB issued ASU No. 2015-17 "Income Taxes: Balance Sheet Classification of Deferred Taxes." ASU 2015-17 simplifies the balance sheet classification of deferred taxes and requires that all deferred taxes be presented as noncurrent. ASU 2015-17 is effective for fiscal years beginning after December 15, 2016 with early adoption permitted. The adoption of this update did not have a material effect on the Company'sCompany’s financial statements.position and results of operations.

F-10
In May 2014, the FASB issued Accounting Standards Update No. 2014-09 (Topic 606) "Revenue from Contracts with Customers." Topic 606 supersedes the revenue recognition requirements in Accounting Standards Codification Topic 605, "Revenue Recognition", and requires entities to recognize revenue when they transfer control of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. The Company is currently assessing the method of adoption and the impact this new guidance will have on its financial statements. The Company expects to adopt these standards using the modified retrospective method. The timing of revenue recognition for variable consideration under our licensing and collaboration agreements may be different as a result of this new guidance. The Company is reviewing its licensing agreement for variable consideration, and if any such consideration exists, whether it should be estimated and recognized earlier than under the current revenue guidance.
In August 2015, the FASB issued ASU No. 2015-14, "Revenue from Contracts with Customers" ("ASU 2015-14") which deferred the effective date by one year to December 15, 2017 for interim and annual reporting periods beginning after that date and allows for adoption using a full retrospective method, or a modified retrospective method. The Company will adopt the new standard in its first quarter 2018 using the modified retrospective method and is currently in the process of evaluating the impact of the adoption of this standard on its financial statements.

3. Foreign Currency Remeasurement

The U.S. dollar has been determined to be the functional currency for the net assets of the Company's laboratory in Freiburg, Germany. The transactions are recorded in the local currencies and are remeasured at each reporting date using the historical rates for nonmonetary assets and liabilities and current exchange rates for monetary assets and liabilities at the balance sheet date. Exchange gains and losses from the remeasurement of monetary assets and liabilities are recognized in other income (loss). The Company recognized a loss of approximately $23,000, $18,000 and $6,000 for the years ended December 31, 2017, 2016 and 2015, respectively.
4. Receivables
At December 31, 2017, the Company had a receivable of $7.5 million as compared to $0.2 million at December 31, 2016, primarily related to amounts recoverable from its insurance carrier, associated with ongoing legal proceedings. Of this amount, approximately $1.7 million and $0.2 million relate to recoverable legal costs and approximately $5.8 million and $0 relate to recoverable legal settlements accrued by the Company as of December 31, 2017 and 2016, respectively (See Note 11). Due to the likelihood of the collectability of the accounts receivable, no allowance was recorded.
5. Prepaid and Other Assets
At December 31, 2017 and 2016, the Company had $1.9 million and $3.4 million, respectively, of prepaid and other current assets, which consist primarily of deposits on contracts for research and development, prepaid insurance and leases for its facility.
6. Equipment and Furnishings

Equipment and furnishings at December 31, 20172023 and 20162022 consist of the following (in thousands):

  2017  2016 
Equipment and furnishings $2,212  $2,811 
Less — accumulated depreciation  (1,169)  (851)
Equipment and furnishings, net $1,043  $1,960 
         
following:

Schedule of Equipment and Furnishings

  2023  2022 
Equipment and furnishings $48,742  $48,742 
Less — accumulated depreciation  (42,031)  (30,196)
Equipment and furnishings, net $6,711  $18,546 

Depreciation and amortization expense for the years ended December 31, 2017, 20162023 and 20152022 were $629,312, $536,631$11,834 and $317,649,$15,004, respectively.

CytRx 2017 10-K Page # F-11#


7.

4. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities at December 31, 20172023 and 20162022 are summarized below (in thousands)


  2017  2016 
Professional fees $209  $193 
Research and development costs  223   2,208 
Litigation settlement  6,450   700 
Wages, bonuses and employee benefits  396   487 
Royalties  626    
Other  125   242 
Total $8,029  $3,830 

8. Deferred Revenues
below.

Schedule of Accrued Expenses and Other Current Liabilities

  2023  2022 
Professional fees $77,785  $77,785 
Wages, bonuses and employee benefits  157,024   203,181 
Royalties and milestones  716,155   716,155 
Other  13,269   18,380 
Total $964,233  $1,015,501 

5. Leases

We lease office space and office copiers related primarily generate revenue through licensing arrangements of our intellectual property.to the Company’s administrative activities. The Company recognizes revenue when amounts are realized or realizableaccounts for leases under ASC 842, Leases, which requires an entity to recognize a right-of-use asset and earned. Revenuea lease liability for virtually all leases.

In January 2020, the Company signed a new four-year office lease which covers approximately 2,771 square feet of office and storage space. This lease was effective March 1, 2020 and extended through February 29, 2024. The monthly rent is considered realizable$15,361. We did not renew this lease. In February 2020, the Company renewed its additional storage space lease, which requires us to make monthly payments of $1,475. The Company recorded a right of use asset and earned when the following criteria are met: (1) persuasive evidencelease liability obligation of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the price is fixed or determinable; and (4) collection$715,310 upon inception of the amounts due are reasonably assured. Amounts received priorthese leases. The Company also reclassified a previously existing right-of-use asset of $66,271 from other assets to satisfying the revenue recognition criteria are recorded as deferred revenue in the Company's balance sheets. Amounts expected to be recognized as revenue within the 12 months followingright-of-use asset.

As of December 31, 2023, the balance sheet dateof right-of-use assets was $31,610, and the balance of total lease liabilities was $33,606.

F-11

Future minimum lease payments under non-cancelable operating leases under ASC 842 as of December 31, 2023 are classified as current liabilities.

Deferred revenue represents amounts received priorfollows:

Schedule of Future Minimum Lease Payments

  

Operating

Lease Payments  

 
     
Jan 2024 – Dec 2024  33,673 
Total future minimum lease payments  33,673 
     
Less: present value adjustment  (67)
Operating lease liabilities at December 31, 2023 $33,606 

The components of rent expense and supplemental cash flow information related to revenue recognition. leases for the period are as follows:

Schedule of Rent Expenses and Supplement Cash Flow Information Related to Leases

  

Year Ended

December 31, 2023

 
Lease Cost    
     
Operating lease cost (included in General and administrative expenses in the Company’s Consolidated Statements of Operations) $200,924 
     
Other information    
     
Cash paid for amounts included in the measurement of lease liabilities for the year ended December 31, 2023 $178,092 
     
Weighted average remaining lease term – operating leases (in years)  0.2 
     
Average discount rate  3.5%

6. Financing Under Security Purchase Agreement

On October 3, 2017, CytRx entered into a Reimbursement Agreement with NantCell, Inc. whereby the Company agreed to reimburse them for payment obligations under certain of the contracts under the NantCell licensing agreement up to a maximum of $4.2 million plus one half of any amounts in excess thereof. Once all conditions of the agreement are met and no contingencies remain outstanding, the revenue will be recognized as licensing fee revenue. CytRx recognized $6.9 million of deferred revenue from the NantCell licensing agreement and anticipates recording this as revenues in 2018, once the Company's cost reimbursement obligations are met.

9. Term Loan
On February 5, 2016,July 13, 2021, the Company entered into a loanSecurities Purchase Agreement (the “Purchase Agreement”) with a single institutional investor (the “Investor”) for aggregate gross proceeds of $10 million and security agreement with Hercules Technology Growth Capital, Inc. ("HTGC"), as administrative agent and lender, and Hercules Technology III, L.P., as lender, pursuant to whichnet proceeds of approximately $9.2 million. The transaction closed on July 16, 2021. Under the lenders made long-term loans toPurchase Agreement, the Company on February 8, 2016 in the aggregate principal amount of $25 million.
The Term Loans bear interest at the daily variable rate per annum equal to 6.0% plus the prime rate, or 10.5%, whichever is greater.  CytRx was required to make interest-only payments on the Term Loans through February 28, 2017,sold and beginning on March 1, 2017 blended equal monthly installments of principal amortization and accrued interest until the maturity date of the Term Loans on February 1, 2020.  Under the terms of the loan, CytRx is required to maintain a minimum cash balance equal to the greater ofissued (i) $10 million or (ii) forward three months projected cash burn. As security under their obligations, the Company issued to the lenders warrants to purchase a total of 105,69120,000 shares of its common stock at a purchase price of $88.00 per share for total gross proceeds of approximately $1.76 million in a registered direct offering (the “Registered Direct Offering”) and (ii) 8,240 shares of Series C 10.00% Convertible Preferred Stock (the “Series C Preferred Stock”) at a purchase price of $1,000 per share, for aggregate gross proceeds of approximately $8.24 million, in a concurrent private placement (the “Private Placement” and, together with the Registered Direct Offering, the “July 2021 Offerings”). The shares of the Series C Preferred Stock were convertible, upon shareholder approval as described below, into an aggregate of up to 93,637 shares of common stock at a conversion price of $88.00 per share. Holders of the Series C Preferred Stock were entitled to receive, cumulative dividends at the rate per share (as a percentage of the stated value per share) of 10.00% per annum, payable quarterly on January 1, April 1, July 1 and October 1, beginning on the first such date after the date of issuance. The terms of the Series C Preferred Stock included beneficial ownership limitations that preclude conversion that would result in the Investor owning in excess of 9.99% of the Company’s outstanding shares of common stock. LadRx also issued to the Investor an unregistered Preferred Investment Option (“PIO”) that prior to redemption and cancelation of the PIO on June 29, 2023 (as described herein) allowed for the purchase of up to 113,637 shares of common stock for additional gross proceeds of approximately $10 million if the PIO was exercised in full. The exercise price of $12.30. These warrants are classifiedfor the PIO was $88.00 per share. The PIO had a term equal to five and one-half years commencing upon the Company increasing its authorized common stock following shareholder approval.

F-12

The Company accounted for these transactions as equity warrants with a single transaction for accounting purposes and allocated total proceeds to the respective instruments based upon the relative fair value of $633,749.  Alleach instrument. The Company determined that the relative fair value of (i) the 20,000 shares of the common stock issued was $859,218, (ii) the relative fair value of the 8,240 shares of Series C Preferred Stock was $4,022,700, and (iii) the relative fair value of the PIO was $4,293,872 based upon a Black Scholes valuation model. As such, the Company recorded as Additional Paid in Capital the fair value of the common stock and PIO of $5,153,090, and the fair value of the Series C Preferred Stock was $4,022,700 which was reflected as mezzanine equity due to certain clauses of the Purchase Agreement.

In 2022, the Company paid the following dividends: on January 1, 2022, $206,000, on April 1, 2022, $202,567, on July 1, 2022, $84,005 and on October 1, 2022, $68,809 for a total of $561,381. On January 3, 2023, the Company paid a dividend of $68,809.

On March 15, 2022, at a special meeting of its stockholders which was originally opened and subsequently adjourned on September 23, 2021, the Company’s stockholders, by an affirmative vote of the majority of the Company’s outstanding principalshares of capital stock, approved the amendment to the Company’s Restated Certificate of Incorporation to effect an increase in the number of shares of authorized common stock, par value $0.001 per share, from 41,666,666 shares to 62,393,940 shares, and accrued interestto make a corresponding change to the number of authorized shares of capital stock in order to comply with the Company’s contractual obligations under the Purchase Agreement.

On March 28, 2022, the Investor converted 4,120 shares of the Series C Preferred Stock in accordance with the initial terms of the agreement and received 46,818 shares of common shares. On May 15, 2022, the Investor converted a further 1,368 shares of the Series C Preferred Stock and received 15,542 shares of common shares, resulting in 2,742 shares of common stock outstanding at December 31, 2022. On January 31, 2023, the Investor converted a further 1,342 shares of Series C Preferred Stock for 15,250 shares of common stock and on May 8, 2023, the term loansInvestor converted its remaining shares of Series C Preferred Shares for 16,027 shares of common stock. As of December 31, 2023, there were no shares of Series C Preferred Stock issued and outstanding.

Terms of Series C Preferred Stock

Under the Certificate of the Designations, Powers, Preferences and Rights of Series C 10.00% Convertible Preferred Stock (the “Certificate of Designations”), each share of Series C Preferred Stock will be due and payable in full onconvertible, subject to the maturity date of February 1, 2020.

On July 28, 2017, CytRx entered into a First Amendment to Loan and Security Agreement with HerculesBeneficial Ownership Limitation (as defined below), at either the holder’s option or at the Company’s option (a “Company Initiated Conversion”) at any time following stockholder approval having been obtained to amend its existing long-term loan facilityour restated certificate of incorporation to increase the number of authorized shares of common stock above 41,666,666 (the "Loan Agreement"“Stockholder Approval”). The amendment provided for payment, on July 28, 2017,, into common stock at a conversion rate equal to the quotient of $5.0 million(i) the Series C Stated Value of $1,000 (the “Series C Stated Value”) plus, in outstanding principalthe case of a Company Initiated Conversion, all accrued and accumulated and unpaid interest due underdividends on such share of Series C Preferred Stock, divided by (ii) the Loan Agreement, plus a $100,000 prepayment charge,initial conversion price of $0.88, subject to specified adjustments for stock splits, stock dividends, reclassifications or other similar events as set forth in the Certificate of Designations.

The Certificate of Designations contains limitations that prevent the holder thereof from acquiring shares of common stock upon conversion that would result in the number of shares of common stock beneficially owned by such holder and for repayment, on or prior to September 30, 2017, of an additional $5.0 million outstanding principal and unpaid interest due under the Loan Agreement, plus a second $100,000 prepayment charge. CytRx also agreed to an updated schedule of monthly payments and a new maturity date of August 1, 2018. Pursuant to the amendment, a portion of the warrants (representing 80%its affiliates exceeding 9.99% of the total number of shares issuableof common stock outstanding immediately after giving effect to the conversion (the “Beneficial Ownership Limitation”), except that upon exercisenotice from the holder to the Company, the holder may increase or decrease the amount of ownership of outstanding shares of common stock after converting the holder’s shares of Series C Preferred Stock, provided that the Beneficial Ownership Limitation in no event exceeds 9.99% of the warrants) was amended to change the exercise pricenumber of that portionoutstanding shares of the warrants from $12.30 per share to $4.62 per share, which was calculated based upon the 30-day volume-weighted average price of our common stock overoutstanding immediately after giving effect to the 30-day period beginning 15 days before the July 28, 2017 announcementissuance of shares of common stock upon conversion of the NantCell license transaction. CytRx evaluatedshares of Series C Preferred Stock held by the amended debt agreement under ASC 470holder and determined itprovided that any increase in the Beneficial Ownership Limitation shall not be effective until 61 days following notice to be a modification and that in accordance with accounting guidance for debt modifications, the incremental fair valueCompany

Each holder of shares of Preferred Stock is entitled to receive dividends, commencing from the date of issuance of the repriced warrantsPreferred Stock. Such dividends may be paid only when, as and if declared by the Board of $77,000 and the $200,000 fee paid to the lender was recorded as additional loan discount to be recognized using the interest method over the remaining lifeDirectors of the loan.  The payment schedule was changed, and the loan will matureCompany (the “Board”), out of assets legally available therefore, quarterly in 2018.

CytRx 2017 10-K Page # F-12#



As security for the Company's obligations under the loan and securities agreement, the Company granted HTGC, as administrative agent, a security interest in substantially all of its existing and after-acquired assets except for its intellectual property and certain other excluded assets.
  
December 31,
2017
  
December 31,
2016
 
Term Loan Principal – Current $9,986,362  $6,214,057 
End Fee Payable  1,771,250    
Issuance Cost/Loan Discount – Current  (1,157,817)  (732,401)
Term Loan, Net – Current $10,599,795  $5,481,656 
         
Long Term Loan Principal $  $18,785,943 
End Fee Payable     1,771,250 
Long Term Loan Discount/Issuance Cost     (2,072,683)
Long Term Loan, Net $  $18,484,510 

10. Warrant Liabilities
Warrants issued in connection with the Company's July 2016 equity public offering and modified in the Company's December 2016 equity public offering are classified as liabilities as opposed to equity due to their settlement terms. These warrants are non-cash liabilities and the Company is not required to expend any cash to settle these liabilities. The fair value of these warrants were recordedarrears on the balance sheetfirst day of January, April, July and October in each year, commencing on the date of issuance, at issuancethe dividend rate of 10.00% per year. Such dividends are cumulative and continue to accrue on a daily basis whether or not declared and whether or not we have assets legally available therefore.

Under the warrants were marked to fair value atCertificate of Designations, each financial reporting period, with changes in the fair value recorded asshare of Series C Preferred Stock carries a gain or loss in the statement of operations. The fair value of the warrants is determined using the Black-Scholes option pricing model, which requires the use of significant judgment and estimates for the inputs used in the model. The warrants issued in connection with the Company's August 2011 equity public offering expired in August 2016. The following reflects the weighted-average assumptions for each of the periods indicated:

  Year Ended December 31, 
  2017  2016  2015 
          
Risk-free interest rate  1.53%  0.90%  0.57%
Expected dividend yield  0%  0%  0%
Expected lives  0.55   1.23   0.59 
  Expected volatility  96.7%  119.1%  61.7%
Number of warrants classified as liabilities  2,834,246   4,752,512   1,061,976 
Gain on warrant liabilities $1,367,777  $3,827,617  $4,437,628 

The dividend yield assumption of zero is based upon the fact the Company has never paid cash dividends and presently has no intention of paying cash dividends. The risk-free interest rate used for each grant isliquidation preference equal to the U.S. Treasury ratesSeries C Stated Value plus accrued and unpaid and accumulated dividends thereon. Such liquidation preference is payable upon certain change in effect atcontrol transactions and accordingly, this instrument is classified as mezzanine (temporary equity).

During the time ofyear ended December 31, 2021, the grant for instruments with a similar expected life. The expected lives are based onCompany did not have enough authorized shares to issue the remaining contractual lives ofissuable shares under the related warrants at the valuation date. The Company's computation of expected volatility is based on the historical daily volatility of its publicly traded stock.

In 2017, 1.2 million warrants expired,Preferred Stock and 0.9 million warrants were exercised resulting in the issuance of 0.9 million shares of the Company's common stock. In 2016, 4.8 million warrants in connection with the July 2016 equity offering were issued.
11. Commitments and Contingencies
Commitments
Preferred Investment Option. The Company acquires assets stillattempted, but was unsuccessful, to obtain stockholders’ approval for the increase in developmentauthorized shares, and enters into research and development arrangements with third parties that often require milestone and royalty paymentsaccordingly, the Company was unable to meet its registration rights obligation as of December 31, 2021. As such, the third-party contingent upon the occurrence of certain future events linked to the success of the asset in development. Milestone payments may be required, up toCompany recognized an aggregate of $7.5approximately $1.1 million contingent uponin liquidated damages during the successful achievementyear ended December 31, 2021, of which includes a provision of $615,123 as an important point inaccrual for estimated damages until stockholders’ approval is achieved and the development life-cycleRegistration Statement is filed. On March 15, 2022, the Company received its stockholders’ approval to increase its authorized shares and filed a certificate of amendment to its Certificate of Incorporation to increase the pharmaceutical product (e.g., approvalnumber of the product for marketing by a regulatory agency). If required, CytRx may also haveauthorized shares from 41,666,666 shares to make royalty payments, based upon a percentage of the sales of the pharmaceutical product. In respect of aldoxorubicin, it agreed to pay up to a maximum amount of approximately $18.3 million, payable in63,227,273 shares of its common stock, in the event that regulatory approval for marketing is obtained.
CytRx 2017 10-K Page # F-13#


   These arrangements may be material individually, and in the unlikely event that milestones for multiple products covered by these arrangements were reached inon the same period, the aggregate charge to expense could be material to the results of operations in any one period. In addition, these arrangements often give CytRx the discretion to unilaterally terminate development of the product, which would allow CytRx to avoid making the contingent payments; however, CytRx is unlikely to cease development if the compound successfully achieves clinical testing objectives.
CytRx's current contractual obligations that will require future cash payments are as follows (in thousands):
  
Operating
Leases (1)
  
Employment Agreements (2)
  
Research and Development (3)
  Total 
2018 $373  $1,678  $1,000  $3,051 
2019  278   1,057      1,335 
  2020  59   1,057      1,116 
  2021     1,057      1,057 
2022            
  Thereafter            
Total $710  $4,849  $1,000  $6,559 
____________


(1)Operating leases are primarily facility lease related obligations, as well as equipment lease obligations with third party vendors. The Company recognized rent expenses of $420,106, $358,247, and $351,075 in 2017, 2016 and 2015, respectively.

(2)Employment agreements include management contracts which have been revised from time to time. The employment agreement for the Company's executive officers provide for minimum salaries, which are adjusted annually at the discretion of the Company's Compensation Committee, and in some cases provide for minimum annual bonuses and employee benefits, as well.  New employment agreements for the Company's other executive officers are usually entered into annually or biennially.

(3)Research and development obligations relate primarily to the Reimbursement Agreement with NantCell. All of these purchase obligations are cancelable.

Contingencies
date. The Company appliesfiled its registration statement registering the disclosure provisions of ASC 460, Guarantees ("ASC 460") to its agreements that contain guarantees or indemnities byshares underlying the Company. The Company provides (i) indemnifications of varying scope and size to certain investors and other parties for certain losses suffered or incurred by the indemnified party in connection with various types of third-party claims; and (ii) indemnifications of varying scope and size to officers and directors against third party claims arising from the services they provide to the Company.

Shareholder Derivative Actions in Delaware.  There are two competing derivative complaints pending in the Delaware Court of Chancery alleging claims related to the Company's alleged retention of DreamTeamGroup and MissionIR.  On December 14, 2015, a shareholder derivative complaint, captioned Niedermeyer et al. v. Kriegsman et al., C.A. No. 11800, was filed against certain of the Company's officers and directors, for which a second amended complaint was filed on October 12, 2016.  On September 6, 2016, one of the plaintiffs in the California litigation (discussed above) effectively refiled his complaint in the Delaware Court of Chancery, with the case captioned Taylor v. Kriegsman, C.A. No. 12720.   Following competing motions for appointment of a lead plaintiff and lead counsel, on February 22, 2017, the Court of Chancery appointed Niedermeyer et al.as lead plaintiffs in the complaint. On May 3, 2017, the parties entered into negotiations with a mediator and on June 2, 2017, the parties entered into a Memorandum of Understanding ("MOU") to settle the entire action. On June 15, 2017, the MOU was submitted to the Court and the parties are now seeking Court approval. The Stipulation of Settlement was filed with the Court on January 22, 2018, which was preliminarily approved by the Court.  A final approval hearing is scheduled for April 19, 2018.  Any petition for an attorney fee award to the Plaintiff's counsel will also be considered by the Court at the April 19, 2018 hearing.
CytRx 2017 10-K Page # F-14#


Class Action in California.  On July 25 and 29, 2016, nearly identical class action complaints were filed in the U.S. District Court for the Central District of California, titled Crihfield v. CytRx Corp., et al., Case No. 2:16-cv-05519 and Dorce v. CytRx Corp., Case No. 2:16-cv-05666 alleging that the Company and certain of its officers violated theRegistrable Securities Exchange Act of 1934 by allegedly making materially false and/or misleading statements, and/or failing to disclose material adverse facts to the effect that the clinical hold placed on the Phase 3 trial of aldoxorubicin for STS would prevent sufficient follow-up for patients involved in the study, thus requiring further analysis, which could cause the trial's results and/or FDA approval to be materially adversely affected or delayed.  The plaintiffs allege that such wrongful acts and omissions caused significant losses and damages to a class of persons and entities that acquired the Company's securities between November 18, 2014 and July 11, 2016, and seek an award of compensatory damages, costs and expenses, including counsel and expert fees, and such other and further relief as the Court may deem just and proper. On October 26, 2016, the Court entered an Order consolidating the actions titled In re: CytRx Corporation Securities Litigation, Master File No. 16-cv-05519-SJO and appointing a Lead Plaintiff and Lead Counsel. Following the filing of a first amended complaint on January 13, 2017, on March 14, 2017 the Company23, 2022 and the individual defendants filed a Motion to Dismiss.  Plaintiff filed an Opposition thereto on April 28, 2017.  The Company and the individual defendants filed a Reply on May 30, 2017 and the matter was heard by the Court on June 12, 2017. On June 14, 2017, the Court issued an Order granting the Motion to Dismiss with leave to amend. Plaintiff filed a Second Amended Complaint and the Individual Defendants filed a renewed Motion to Dismiss. Plaintiff filed an Opposition thereto on July 24, 2017. The Company and the Individual Defendants filed a Reply on July 31, 2017. On August 14, 2017, the Court issued an Order granting in part and denying in part the motion to dismiss. On September 18, 2017, the Court issued an Order setting a scheduleprovided for the case.  On January 30, 2018, the parties entered into negotiations with a mediator and on February 1, 2018, the parties entered into a confidential Term Sheet to settle the Class Action. On February 7, 2018, the Court stayed the action for all purposes until May 2, 2018, to provide the parties sufficient time to prepare and submit a stipulation of settlement.
Shareholder Derivative Action in Delaware (Zyontz). On October 17, 2017, a shareholder derivative complaint was filed against certain current and former directors in the Delaware Court of Chancery, entitled Zyontz v. Kriegsman et al., Case No. 2017-0738-JRS. The complaint essentially sets forth the allegations pled in the federal securities class action in California, asserts a claim for breach of fiduciary duty, and seeksliquidated damages fees and costs, and other and further relief as the Court may deem just and proper. On December 18, 2017, the Company and individual defendants filed a motion to dismiss for failure to make a demand on the Board and for failure to state a claim, and a motion to stay the proceedings pending resolution of the federal securities class action.  On January 30, 2018, the parties participated in a mediation.  The parties are currently negotiating a settlement agreement comprised of corporate governance reformsthrough that will be submitted to the Court of Chancery for approval.
Shareholder Derivative Action in Delaware (Patterson). On September 1, 2017, a shareholder derivative complaint was filed against the current directors in the Delaware Court of Chancery, entitled Patterson v. Kriegsman et al., C.A. No. 2017-0636-TMR. The complaint sets forth claims for breach of fiduciary duty for allegedly disseminating false and misleading information, unjust enrichment, gross mismanagement, abuse of control and corporate waste based on allegations concerning various business decisions matters. The complaint seeks damages, corporate governance reforms, restitution, fees and costs, and other and further relief as the Court may deem just and proper. On September 26, 2017, the Company and individual defendants filed a motion to dismiss the complaint, for which the opening brief in support of such motion was filed on November 3, 2017, the plaintiff's opposition was filed on December 11, 2017, and the defendants' reply was filed on January 5, 2018.  The hearing on the motion to dismiss was heard by the Vice-Chancellor on March 8, 2018, and she took the matter under advisement. On March 13, 2018, the Vice-Chancellor ruled that defendants' motion to dismiss was granted, with prejudice.  
The Company intends to vigorously defend against the foregoing complaints. CytRx has directors' and officers' liability insurance, which will be utilized in the defense of these matters. The liability insurance may not cover all of the future liabilities the Company may incur in connection with the foregoing matters. These claims are subject to inherent uncertainties, and management's view of these matters may change in the future.
The Company evaluates developments in legal proceedings and other matters on a quarterly basis. The Company records accruals for loss contingencies to the extent that the Company concludes that it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated. The Company has accrued $6.5 million of litigation settlements related to legal actions.
12. Equity Transactions
date. As of December 31, 2017,2023, all liquidated damages had been paid and we no longer have any liabilities related to the Registration Rights Agreement.

F-13

7. Stock Compensation

Stock Options

The Company has reserved approximately 1.2 million of its authorized but unissueda 2008 Stock Incentive Plan under which 50,000 shares of common stock for future issuance pursuant to its employee stock option plans issued to employees and consultants.

In December 2017, the Company issued an additional 12,268 fractional shares of its common stock as a result of is 1 to 6 reverse stock split and issued 387,597 shares in restricted common stock (see Note 13).
In the second and third quarters of 2017, a total of 880,788 shares of the Company's common stock were issued from the exercise of warrants and options.
CytRx 2017 10-K Page # F-15#


   On July 27, 2017, the Company issued 1,969,697 shares of its common stock and 500,000 warrants to purchase common stock as part of an exclusive licensing agreement granted to NantCell, Inc.
On May 2, 2017, the Company issued 5 million of its common stock in a public offering.
In the first quarter of 2017, the Company converted 518 shares of its Series B preferred stock in exchange for 1,233,334 shares of its common stock.
In 2016, the Company issued 55,000 shares of its common stock resulting from the exercise of employee stock options and issued 387,597 shares in restricted common stock.
On December 16, 2016, the Company issued 1,923,457 shares of its common stock and 550 convertible preferred shares at a stated value of $1,000, and repriced 3,232,981 warrants from the July 2016 financing, from $4.20 to $3.06 per common stock, along with extending their term through July 2018, all in respect of a public offering. As a result of the Series B conversion price of $2.52 being less than the common stock price at the closing date, a beneficial conversion feature was recognized in the amount of $0.3 million. Since the preferred stock was immediately convertible, the entire beneficial conversion feature was recognized as a deemed dividend on December 16, 2016. In December 2016, 32 preferred shares were converted at their conversion rate of $2.52 in exchange for 76,191 common shares.
On July 20, 2016, the Company issued 4,761,905 shares of its common stock and one-year warrants to purchase an equal number of shares of its common stock in a public offering.
On October 26, 2015, the Company retired 33,213 shares of its treasury stock at cost ($2.6 million).
On July 24, 2015, the Company issued 1,744,167 shares of common stock in a public offering.
13. Stock Options and Equity-Classified Warrants
Stock Options
The Company has a 2000 Long-Term Incentive Plan under which 233,334 shares of common stock were originallyare reserved for issuance. As of December 31, 2017,2023, there were 44,371shares10,500 shares subject to outstanding stock options.options and approximately 8,000 shares outstanding related to restricted stock grants issued from the 2008 Plan. This plan expired on August 6, 2010,November 20, 2018 and thus no further shares are available for future grant under this plan.
The

In November 2019, the Company also hasadopted a 20082019 Stock Incentive Plan under which 5 million54,000 shares of common stock are reserved for issuance. As of December 31, 2017,2023, there were 2.8 million3,500 shares subject to outstanding stock options and 0.8 million250 shares outstanding related to restricted stock grants issued from the 20082019 Plan. This Plan expires on November 14, 2029.

All outstanding options issued to employees, directors and 1.2 million shares available for future grant under this plan.

The Company follows the provisions of ASC 718, Compensation-Stock Compensation, which requires the measurement and recognition ofconsultants were fully vested in 2020. As such, no further stock compensation expense for all stock-based awards made to employees.
The fair value ofwas recognized during the stock options at the date of grant was estimated using the Black-Scholes option-pricing model, based on the following assumptions:
  2017  2016  2015 
Risk-free interest rate  2.04% - 2.35%  1.20% - 2.26%  1.74% - 2.12%
Expected volatility  86% - 92%  74% - 88%  74% - 85%
Expected lives (years)  6 - 10   6 - 10   6 - 10 
Expected dividend yield  0.00%  0.00%  0.00%

The Company's computation of expected volatility is based on the historical daily volatility of its publicly traded stock. For option grants issued during years ended December 31, 2017, 20162023 and 2015,2022.

On September 7, 2023, the Company used a calculated volatility for each grant.Board approved the first amendment (the “Plan Amendment”) to the 2019 Plan, effective as of the same date. The Company lacks adequate information aboutPlan Amendment amends the exercise behavior at this time2019 Plan to (i) reflect the Company’s recent name change from CytRx Corporation to LadRx Corporation, and has determined(ii) increase the expected term assumptionaggregate number of shares of common stock that may be issued under the simplified method provided for under ASC 718, which averages the contractual term2019 Plan, as set forth in Section 4(a) of the Company's2019 Plan, by an additional 75,000 shares of common stock.

There were no stock options issued to employees, directors and consultants in 2023 and 2022.

During the year ended December 31, 2023, there were no options exercised. During the year ended December 31, 2022, options to acquire 500 shares of ten years withcommon stock were exercised on a cashless basis in exchange for 214 shares of common stock.

The following table sets forth the average vesting termtotal stock-based compensation expense resulting from restricted stock included in our Consolidated Statements of three yearsOperations for an average of six years. The dividend yield assumption of zero is based upon the fact the Company has never paid cash dividends and presently has no intention of paying cash dividends. The risk-free interest rate used for each grant is equal to the U.S. Treasury rates in effect at the time of the grant for instruments with a similar expected life. Based on historical experience, for each of the two years ended December 31, 20162023 and 2015, the Company has estimated an annualized forfeiture rate2022:

Schedule of 10% for options granted to its employees, 2% for options granted to senior management and 0% for options granted to directors.Stock-based Compensation costs will be adjusted for future changes in estimated forfeitures. The Company will record additional expense if the actual forfeitures are lower than estimated and will record a recoveryExpense

  Years Ended December 31, 
  2023  2022 
General and administrative – employee $  $11,255 
Total employee stock-based compensation $  $11,255 

Schedule of prior expense if the actual forfeiture rates are higher than estimated. On January 1, 2017, the Company adopted ASU 2016-09 and made a policy election to recognize forfeitures as they occur. The adoption of ASU 2016-09 did not have a material impact to the Company's financial condition or results of operations. No amounts relating to stock-based compensation have been capitalized. No amounts relating to employee stock-based compensation have been capitalized.Stock Option Activity

  Stock Options  

Weighted Average

Exercise Price

 
  2023  2022  2023  2022 
Outstanding — beginning of year  14,001   24,628  $768.00  $768.00 
Granted            
Exercised     (500)     26.00 
Forfeited  (2,001)         
Expired  (1,650)  (10,127)  2,796.00   1,462.00 
Outstanding — end of year  10,350   14,001   501.70   768.00 
Exercisable at end of year  10,350   14,001  $501.70  $768.00 
Weighted average fair value of stock options granted during the year: $  $         

F-14
CytRx 2017 10-K Page # F-16#


At December 31, 2017, there remained approximately $1.8 million of unrecognized compensation expense related to unvested stock options granted to current employees and directors, to be recognized as expense over a weighted-average period of 1.15 years.

Presented below is the Company's stock option activity for employees and directors:

  Stock Options  
Weighted Average
Exercise Price
 
  2017  2016  2015  2017  2016  2015 
Outstanding — beginning of year  2,813,280   2,263,977   1,559,765  $14.14  $18.66  $16.98 
Granted  591,369   809,500   765,000   1.87   3.54   15.66 
Exercised  (19,213)  (55,000)  (47,857)  2.58   12.84   12.30 
Forfeited  (874,210)  (196,054)     13.11   20.94    
Expired  (19,047)  (9,143)  (12,931)  56.88   48.18   33.48 
Outstanding — end of year  2,492,179   2,813,280   2,263,977   11.35   14.14   18.66 
Exercisable at end of year  1,701,445   1,811,320   1,336,694  $14.85  $17.70  $20.70 
Weighted average fair value of stock options granted during the year: $1.47  $2.58  $11.28             


For stock options paid in consideration of services rendered by non-employees, the Company recognizes compensation expense in accordance with the requirements of ASC 505-50.
Non-employee option grants that do not vest immediately upon grant are recorded as an expense over the vesting period. At the end of each financial reporting period prior to performance, the value of these options, as calculated using the Black-Scholes option pricing model, is determined, and compensation expense recognized or recovered during the period is adjusted accordingly. Since the fair market value of options granted to non-employees is subject to change in the future, the amount of the future compensation expense is subject to adjustment until the common stock options are fully vested.
The Company recorded approximately $422,000, $0 and $0 of non-cash charges related to the issuance of stock options to certain consultants in exchange for services during 2017, 2016 and 2015, respectively.
At December 31, 2017, there was no unrecognized compensation expense related to unvested non-employee stock options. Presented below is the Company'sCompany’s non-employee stock option activity:
  
Stock Options
  
Weighted Average
Exercise Price
 
  2017  2016  2015  2017  2016  2015 
Outstanding — beginning of year  100,000   105,952   115,357  $16.41  $18.12  $20.82 
Granted  273,333         1.78       
Exercised                  
Expired/Forfeited     (5,952)  (9,405)     46.62   51.24 
Outstanding — end of year  373,333   100,000   105,952   5.70   16.41   18.12 
Exercisable at end of year  373,333   100,000   105,952  $5.70  $16.41  $18.12 
Weighted average fair value of stock options granted during the year: $1.54  $  $             

The fair value

Schedule of the stock options at the date of grant was estimated using the Black-Scholes option-pricing model, based on the following assumptions:

  2017  2016  2015 
Risk-free interest rate  2.30% - 2.35%      
Expected volatility  92.00%      
Expected lives (years)  10       
Expected dividend yield         

CytRx 2017 10-K Page # F-17#


Stock Option Activity

  Stock Options  

Weighted Average

Exercise Price

 
  2023  2022  2023  2022 
Outstanding — beginning of year  3,650   3,650  $549.00  $549.00 
Granted            
Exercised            
Expired/Forfeited            
Outstanding — end of year  3,650   3,650   549.00   549.00 
Exercisable at end of year  3,650   3,650  $549.00  $549.00 
Weighted average fair value of stock options granted during the year: $  $         

The following table summarizes significant ranges of outstanding stock options under the two plans at December 31, 2017:

Range of
Exercise Prices
  
Number of Options
  
Weighted Average
Remaining Contractual Life
(years)
  
Weighted Average
Exercise Price
  
Number of
Options
Exercisable
  
Weighted Average
Contractual Life
  
Weighted Average
Exercise Price
 
$1.50 — 1.75   829,702   9.96  $1.75   400,000   9.96  $1.75 
$1.76 —11.00   720,970   7.98   4.76   469,910   7.47   5.92 
$11.01 — 15.00   776,290   7.20   13.92   667,290   7.07   13.80 
$15.01 — 195.30   538,550   5.44   27.36   537,578   5.43   27.36 
                           
     2,865,512   7.86  $10.62   2,074,778   7.29  $13.21 

2023:

Schedule of Ranges of Outstanding Stock Options

Range of
Exercise
Prices
  Number of Options  Weighted-
Average Remaining Contractual Life (years)
  Weighted-
Average Exercise Price
  Number of Options Exercisable  Weighted-
Average Remaining Contractual Life (years)
  Weighted-
Average Exercise Price
 
$26.00 - $100.00   3,500   5.95  $26.00   3,500   5.95  $26.00 
$101.00 - $200.00   6,066   3.71  $195.29   6,066   3.71  $195.29 
$201.00 - $300.00   3,499   1.83  $1,201.20   3,499   1.83  $1,201.20 
$301.00 - $4,146.00   935   0.80  $1,656.29   935   0.80  $1,656.29 
     14,000   3.61  $501.70   14,000   3.61  $501.70 

There was no aggregate intrinsic value toof the outstanding options and options vested and options exercised during 2017.

The following table sets forth the total stock-based compensation expense resulting from stock options included in the Company's Statementsas of Operations:
  Years Ended December 31, 
  2017  2016  2015 
Research and development - employee $549,315  $1,822,508  $1,590,267 
General and administrative - employee  1,909,729   4,661,795   5,568,537 
       Total employee stock-based compensation $2,459,044  $6,484,303  $7,158,804 
             
Research and development – non-employee $11,600  $  $ 
General and administrative – non-employee  410,400   235,764   225,852 
      Total non-employee stock-based compensation $422,000  $235,764  $225,852 

Restricted Stock
In December 2017, the Company granted to Steven Kriegsman, Chief Executive Officer, 387,597 shares of restricted common stock, pursuant to the 2008 Plan. This restricted stock vests in equal annual instalments over three years.  The fair value of the restricted stock is based on the market price of the Company's shares on the grant date less the par value received as consideration.  The fair value of the restricted stock on the grant date was $679,000. In December 2016, the Company granted to Steven Kriegsman, Chief Executive Officer, 387,597 shares of restricted common stock, pursuant to the 2008 Plan. This restricted stock vests in equal annual instalments over three years.  The fair value of the restricted stock is based on the market price of the Company's shares on the grant date less the par value received as consideration.  The fair value of the restricted stock on the grant date was $1,000,000.  The Company did not issue any restricted stock for the year ended December 31, 2015. The Company recorded an employee stock-based compensation expense for restricted stock of approximately $344,000, $15,000 and $0 for the years ended December 31, 2017, 2016 and 2015, respectively.
CytRx 2017 10-K Page # F-18#


2023.

Equity-Classified Warrants

In July 2017, pursuant to a Loan amendment (see Note 9), a portion of the warrants (representing 80% of the total number of shares issuable upon exercise of the warrants) was amended to change the exercise price of 84,554 warrants to $12.30 per share from $4.62 per share.
In July 2017, the Company issued 500,000 warrants to purchase common stock as part of an exclusive licensing agreement granted to NantCell, Inc.
In December 2016, the Company issued to a consultant an eighteen-month contingent warrant to purchase 333,334 shares of common stock at an exercise price of $4.20. No expense was recorded due to the performance contingent nature of the warrants.
In February 2016, in connection with a loan and security agreement with Hercules Technology Growth Capital, Inc. and Hercules Technology III, L.P. ("lenders") (see Note 9), the Company issued to the lenders warrants to purchase a total of 105,691 shares of our common stock at an exercise price of $12.30. These warrants had a fair value of $633,749 on the date of issuance and were recorded as a loan discount.
In February 2016, the Company also issued a warrant to a consultant to purchase 83,334 shares of our common stock at an exercise price of $10.44. These warrants will be fully vested by February 2018. The warrant expense in 2017 and 2016, recognized as non-employee stock-based compensation expenses, was $41,865 and $157,797, respectively.

A summary of the Company'sCompany’s warrant activity and related information for the years ended December 31, 2023 and 2022 are shown below.

  Warrants  
Weighted Average
Exercise Price
 
  2017  2016  2015  2017  2016  2015 
Outstanding — beginning of year  5,417,155   1,204,245   1,224,960  $4.08  $25.68  $25.62 
Granted  584,554   5,284,263      6.31   3.72    
Exercised  (861,581)  (9,393)  (1,667)  3.66   4.20   15.00 
Forfeited                  
Expired  (1,159,347)  (1,061,960)  (19,048)  4.92   26.88   22.92 
Outstanding — end of year  3,980,781   5,417,155   1,204,245   4.26   4.08   25.68 
Exercisable at end of year  3,626,613   5,031,715   1,204,245  $4.23  $4.02  $25.68 
Weighted average fair value of warrants granted during the year: $1.65  $1.56  $             

Schedule of Warrants Activity and Related Information

  Warrants  

Weighted Average

Exercise Price

 
  2023  2022  2023  2022 
Outstanding — beginning of year  42   42  $3,360.00  $3,360.00 
Granted            
Exercised            
Forfeited            
Expired            
Outstanding — end of year  42   42   3,360.00   3,360.00 
Exercisable at end of year  42   42  $3,360.00  $3,360.00 
Weighted average fair value of warrants granted during the year: $  $         

The following table summarizes additional information concerningoutstanding warrants outstanding and exercisable atas of December 31, 2017:2023 had no intrinsic value.

F-15

         
Warrants Outstanding
          
Range of
Exercise Prices
  
Number of Shares
  
Weighted Average
Remaining Contractual Life
(years)
  
Weighted Average
Exercise Price
  
Number of
Warrants
Exercisable
  
Weighted Average
Contractual Life
  
Weighted Average
Exercise Price
 
$3.00 — 6.00   3,252,137   0.60  $3.19   2,918,803   0.62  $3.08 
$6.01 — 9.00   500,000   1.07   6.60   500,000   1.07   6.60 
$9.01 — 12.00   83,335   3.11   10.44   62,501   3.11   10.44 
$12.01 — 33.60   145,309   1.19   16.65   145,309   1.19   16.65 
                           
     3,980,781   0.74  $4.26   3,626,613   0.75  $4.23 

8. Xoma

Royalty Purchase Agreement with XOMA

On June 21, 2023, the Company, entered into (i) a Royalty Purchase Agreement (the “Royalty Agreement”) with XOMA (US) LLC (“XOMA”), for the sale, transfer, assignment and conveyance of the Company’s right, title and interest in and to certain royalty payments and milestone payments with respect to aldoxorubicin, and (ii) an Assignment and Assumption Agreement (the “Assignment Agreement”) with XOMA for the sale, transfer, assignment and conveyance of the Company’s right, title and interest in the Asset Purchase Agreement (the “2011 Arimoclomol Agreement”) between the Company and Orphazyme ApS (“Orphazyme”), dated as of May 13, 2011, and assigned to Zevra Denmark A/S (“Zevra Denmark”), effective as of June 1, 2022, which includes certain royalty and milestone payments with respect to arimoclomol. The combined aggregate purchase price paid to the Company for the sale, transfer, assignment and conveyance of the Company’s right, title and interest in and to aldoxorubicin and arimoclomol was $5 million, less certain transaction fees and expenses.

The Royalty Agreement and the Assignment Agreement also provide for up to an additional $6 million based on regulatory and commercial milestones related to the development of arimoclomol and aldoxorubicin by their respective sponsors, Zevra, Inc. and Immunity Bio. The $6 million in potential post-closing payments is comprised of $1 million upon acceptance by the FDA of the arimoclomol New Drug Application (“NDA”), $1 million upon first commercial sale of arimoclomol, and $4 million upon FDA approval of aldoxorubicin. All royalty and milestone payments made to XOMA will be net of the existing licensing and milestone obligations owed by LadRx related to arimoclomol and aldoxorubicin.

Pursuant to the Royalty Agreement, the Company agreed to sell, transfer, assign and convey to XOMA, among other payments, all royalty payments and regulatory and commercial milestone payments payable to the Company pursuant to the worldwide license agreement, dated July 27, 2017, by and between the Company and Immunity Bio, Inc.. The Royalty Agreement also provides for the sharing of certain rights with XOMA to bring any action, demand, proceeding or claim as related to receiving such payments.

Management determined that the Royalty Agreement is not considered to be with a customer, and it does not fall within the scope of ASC 606. Instead, the Royalty Agreement represents an in-substance sale of nonfinancial assets, and, therefore, should be accounted for within the scope of ASC 610-20. As such, the Company recognized such net proceeds of $4.2 million as other income in the accompanying statement of operations.

Assignment and Assumption Agreement with XOMA

On June 21, 2023, the Company entered into the Assignment Agreement with XOMA, pursuant to which, among others, the Company agreed to sell, transfer and assign to XOMA the Company’s right, title and interest in the arimoclomol pursuant to the 2011 Arimoclomol Agreement, including the right to receive certain milestone, royalty and other payments from Zevra Denmark.

Pursuant to the Assignment Agreement, the Company is entitled to receive (i) a one-time payment of $1 million upon acceptance of a re-submission of an NDA to the FDA for arimoclomol, and (ii) a one-time payment of $1 million upon the first invoiced sale in certain territories of a pharmaceutical product derived from arimoclomol as an active pharmaceutical ingredient, subject to the receipt of the applicable regulatory approval required to sell such a product in such countries. In January 2024, Zevra announced the FDA had accepted the NDA for arimoclomol and the Company received the one-time payment of $1 million in February 2024.


F-16
CytRx 2017 10-K Page # F-19#


14.

9. Stockholder Protection Rights Plan

Effective April 16, 1997,

On December 13, 2019, the Company's boardBoard of directorsDirectors of the Company, authorized and declared a distributiondividend of one right ("Rights"(a “Right”) for each outstanding share of the Company'sCompany’s issued and outstanding shares of common stock, par value $0.001 per share. The dividend was paid to the stockholders of record at the close of business on May 15, 1997 and for each shareDecember 23, 2019. Each Right entitled the registered holder, subject to the terms of common stock issued by the Company thereafter and prior to a Flip-in DateOriginal Rights Agreement (as defined below). Each Right entitles the registered holder, to purchase from the Company one-ten thousandth (1/10,000th)one one-thousandth of a share of the Company’s Series AB Junior Participating Preferred Stock, par value $0.01 per share (the “Preferred Stock”), at an exercisea price of $30. $5.00 (the “Purchase Price”), subject to certain adjustments. The description and terms of the Rights were set forth in the Rights Agreement, dated as of December 13, 2019 (the “Original Rights Agreement”), by and between the Company and American Stock Transfer & Trust Company, LLC, as Rights Agent (the “Rights Agent”).

On November 12, 2020, the Board approved an amendment and restatement of the Original Rights Agreement (as amended and restated, the “Amended and Restated Rights Agreement”) to effect certain changes to the Original Rights Agreement, including (i) reducing the duration to a term of three years, subject to certain earlier expiration as described in more detail below, and (ii) lowering the beneficial ownership threshold at which a person or group of persons becomes an Acquiring Person (as defined below) to 4.95% or more of the Company’s outstanding shares of Common Stock, subject to certain exceptions. The Amended and Restated Rights Agreement is designed to discourage (i) any person or group of persons from acquiring beneficial ownership of more than 4.95% of the Company’s shares of Common Stock and (ii) any existing stockholder currently beneficially holding 4.95% or more of the Company’s shares of Common Stock from acquiring additional shares of the Company’s Common Stock.

The purpose of the Amended and Restated Rights Agreement is to protect value by preserving the Company’s ability to utilize its net operating losses and certain other tax attributes (collectively, the “Tax Benefits”) to offset potential future income tax obligations. The Company’s ability to use its Tax Benefits would be substantially limited if it experiences an “ownership change,” as such term is defined in Section 382 of the Internal Revenue Code of 1986, as amended (the “Tax Code”). A corporation generally will experience an ownership change if the percentage of the corporation’s stock owned by its “5-percent shareholders,” as defined in Section 382 of the Tax Code, increases by more than 50 percentage points over their lowest ownership percentage within a rolling three-year period. The Amended and Restated Rights Agreement is intended to reduce the likelihood the Company would experience an ownership change under Section 382 of the Tax Code.

The Rights are generallywill not be exercisable until 10the earlier to occur of (i) the close of business dayson the tenth business day after ana public announcement by the Companyor filing that a person or group of affiliated or associated persons (an "Acquiring Person")has become an “Acquiring Person,” which is defined as a person or group of affiliated or associated persons that, at any time after the date of the Amended and Restated Rights Agreement, has acquired, or obtained the right to acquire, beneficial ownership of 15%4.95% or more of the Company's thenCompany’s outstanding shares of common stock (a "Flip-in Date").

InCommon Stock, subject to certain exceptions or (ii) the eventclose of business on the Rights become exercisabletenth business day after the commencement of, or announcement of an intention to commence, a tender offer or exchange offer the consummation of which would result in any person becoming an Acquiring Person (the earlier of such dates being called the “Distribution Date”) (provided, however, that if such tender or exchange offer is terminated prior to the occurrence of the Distribution Date, then no Distribution Date shall occur as a result of such tender or exchange offer).

The Rights, which are not exercisable until the acquisitionDistribution Date, will expire at or prior to the earliest of (i) the close of business on November 16, 2023; (ii) the time at which the Rights are redeemed pursuant to the Amended and Restated Rights Agreement; (iii) the time at which the Rights are exchanged pursuant to the Amended and Restated Rights Agreement; (iv) the time at which the Rights are terminated upon the occurrence of certain mergers or other transactions approved in advance by the Board; and (v) the close of business on the date set by the Board following a determination by the Board that (x) the Amended and Restated Rights Agreement is no longer necessary or desirable for the preservation of the Tax Benefits or (y) no Tax Benefits are available to be carried forward or are otherwise available (the earliest of (i), (ii), (iii), (iv) and (v) is referred to as the “Expiration Date”).

F-17

Each share of Preferred Stock will be entitled, when, as and if declared, to a preferential per share quarterly dividend payment equal to the greater of (i) $1.00 per share or (ii) an amount equal to 1,000 times the dividend declared per share of Common Stock. Each share of Preferred Stock will entitle the holder thereof to 1,000 votes on all matters submitted to a vote of the stockholders of the Company. In the event of any merger, consolidation or other transaction in which shares of Common Stock are converted or exchanged, each share of Preferred Stock will be entitled to receive 1,000 times the amount received per one share of Common Stock.

The Purchase Price payable, and the number of shares of Preferred Stock or other securities or property issuable, upon exercise of the Rights are each subject to adjustment from time to time to prevent dilution (i) in the event of a stock dividend on, or a subdivision, combination or reclassification of the Preferred Stock, (ii) upon the grant to holders of the Preferred Stock of certain rights or warrants to subscribe for or purchase Preferred Stock or convertible securities at less than the then-current market price of the Preferred Stock or (iii) upon the distribution to holders of the Preferred Stock of evidences of indebtedness or assets (excluding regular periodic cash dividends or dividends payable in Preferred Stock) or of subscription rights or warrants (other than those referred to above). The number of outstanding Rights and the number of one one-thousandths of a share of Preferred Stock issuable upon exercise of each Right will enableare also subject to adjustment in the owner,event of a stock split, reverse stock split, stock dividends and other similar transactions involving the Common Stock.

In the event that any person or group of affiliated or associated persons becomes an Acquiring Person, each holder of a Right, other than the Rights beneficially owned by the Acquiring Person, affiliates and associates of the Acquiring Person and certain transferees thereof (which will thereupon become null and void), will thereafter have the right to purchasereceive upon exercise of a Right that number of shares of Common Stock having a market value of two times the Purchase Price.

In the event that, after a person or a group of affiliated or associated persons has become an Acquiring Person, the Company is acquired in a merger or other business combination transaction, or 50% or more of the Company’s assets or earning power are sold, proper provision will be made so that each holder of a Right will thereafter have the right to receive, upon the exercise thereof at the Right's then-current exercisepurchase price aof the Right, that number of shares of common stock withof the acquiring company having a market value at the time of that transaction equal to twicetwo times the exercise price. In addition,Purchase Price.

With certain exceptions, no adjustment in the Purchase Price will be required unless such adjustment would require an increase or decrease of at least one percent (1%) in the Purchase Price. No fractional shares of Preferred Stock will be issued (other than fractions which are integral multiples of one one-thousandth of a share of Preferred Stock, which may, at the election of the Company, be evidenced by depositary receipts) and, in lieu thereof, an adjustment in cash will be made based on the market price of the Preferred Stock on the trading day immediately prior to the date of exercise.

At any time after any person or group of affiliated or associated persons becomes an Acquiring Person ownsand prior to the acquisition of beneficial ownership by such Acquiring Person of 50% or more than 50% of the outstanding shares of common stock,Common Stock, the Board, of Directorsat its option, may elect to exchange all outstanding Rightseach Right (other than thoseRights owned by such Acquiring Person)person or group of affiliated or associated persons which will have become void), in whole or in part, at an exchange ratio of one share of common stockCommon Stock per Right. Alloutstanding Right (subject to adjustment).

In connection with any exercise or exchange of the Rights, no holder of a Right will be entitled to receive shares of Common Stock if receipt of such shares would result in such holder, together with such holder’s affiliates and associates, beneficially owning more than 4.95% of the then-outstanding Common Stock (such shares, the “Excess Shares”) and the Board determines that are ownedsuch holder’s receipt of Excess Shares would jeopardize or endanger the value or availability of the Tax Benefits or the Board otherwise determines that such holder’s receipt of Excess Shares is not in the best interests of the Company. In lieu of such Excess Shares, such holder will only be entitled to receive cash or a note or other evidence of indebtedness with a principal amount equal to the then-current market price of the Common Stock multiplied by the number of Excess Shares that would otherwise have been issuable.

At any persontime before the Distribution Date, the Board may redeem the Rights in whole, but not in part, at a price of $0.001 per Right (subject to certain adjustments) (the “Redemption Price”). The redemption of the Rights may be made effective at such time, on such basis and with such conditions as the Board in its sole discretion may establish.

F-18

Immediately upon the action of the Board electing to redeem or exchange the Rights, the Company shall make a public announcement thereof, and upon such election, the right to exercise the Rights will terminate and the only right of the holders of Rights will be to receive the Redemption Price.

Until a Right is exercised or exchanged, the holder thereof, as such, will have no rights as a stockholder of the Company, including, without limitation, the right to vote or to receive dividends.

The Board may amend or supplement the Amended and Restated Rights Agreement without the approval of any holders of Rights, including, without limitation, in order to (a) cure any ambiguity, (b) correct inconsistent provisions, (c) alter time period provisions, including the Expiration Date, or (d) make additional changes to the Amended and Restated Rights Agreement that the Board deems necessary or desirable. However, from and after the date suchany person or group of affiliated or associated persons becomes an Acquiring Person, willthe Amended and Restated Rights Agreement may not be null and void.

The Rights have been distributed to protectsupplemented or amended in any manner that would adversely affect the Company's stockholders from coercive or abusive takeover tactics and to giveinterests of the Boardholders of Directors more negotiating leverage in dealing with prospective acquirers. In July 2016, the Company extended the stockholder rights plan through April 2022.
15. Rights.

10. Income Taxes

At December 31, 2017,2023, the Company had federal and state net operating loss carryforwards (“NOLs”) of $373.7$337.7 million and $236.3$261.5 million, respectively, available to offset against future taxable income, whichincome. Of this amount, $309.8 million of federal NOLs expire in 20182024 through 2037.

The federal operating losses after 2018 totaling $27.9 million carry forward indefinitely but are only able to offset 80% of taxable income in future years. The California NOLs expire in 2029 through 2042.

As a result of a change in-control that occurred in the CytRxLadRx shareholder base, in 2013, approximately $136.8$59.3 million in federal net operating loss carryforwards became substantially limited in their annual availability. Management currently believes that the remaining $236.9$278.4 million in federal net operating loss carryforwards, and the $236.3$202.2 million in state net operating loss carryforwards, are unrestricted.

As of December 31, 2017, CytRx2023, LadRx also had research and development tax credits for federal and state purposes of approximately $16.6$15.4 million and $21.9$15.4 million, respectively, available for offset against future income taxes, which expire in 20222024 through 2037.2036. The credits are subject to change-in-control limitations, which may affect their utilization in future years. Based on an assessment of all available evidence including, but not limited to, the Company'sCompany’s limited operating history in its core business and lack of profitability, uncertainties of the commercial viability of its technology, the impact of government regulation and healthcare reform initiatives, and other risks normally associated with biotechnology companies, the Company has concluded that it is more likely than not that these net operating loss carryforwards and credits will not be realized and, as a result, a 100%100% deferred tax valuation allowance has been recorded against these assets.

On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (the 2017 Tax Act) was enacted reducing the corporate tax rate from 35% to 21% which is effective on January 1, 2018. The carrying value of the Company's deferred tax assets is also determined by the enacted U.S. corporate income tax rate. Consequently, any changes in the U.S. corporate income tax rate have impacted the carrying value of the Company's deferred tax assets. Under the new corporate income tax rate of 21%, deferred income taxes decreased but there is a corresponding decrease to the valuation allowance. Therefore, the 2017 Tax Act is expected to have no impact on the Company's 2017 earnings. Staff Accounting Bulletin No. 118 ("SAB 118") was issued to address the application of US GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Act. In accordance with SAB 118, the Company has determined that the $27.3 million of deferred tax expense recorded in connection with the remeasurement of certain deferred tax assets and liabilities.
The Company implemented ASU 2016-09 during the first quarter of 2017 as stipulated in the FASB guidance for publicly-traded entities. To account for the implementation of ASU 2016-09, the Company accounted for previously unrecognized excess tax benefits by recognizing those benefits. Due to the Company's full valuation allowance, this recognition has no effect on the net accrual after the valuation allowance.

Deferred income taxes reflect the net effect of temporary differences between the financial reporting carrying amounts of assets and liabilities and income tax carrying amounts of assets and liabilities. The components of the Company'sCompany’s deferred tax assets and liabilities, all of which are long-term, are as follows (in thousands):

  December 31, 
  2017  2016 
Deferred tax assets:      
Net operating loss carryforwards $66,251  $126,244 
Tax credit carryforwards  33,899   29,970 
Equipment, furnishings and other  4,909   9,297 
Total deferred tax assets  105,059   165,511 
Deferred tax liabilities     (301)
Net deferred tax assets  105,059   165,210 
Valuation allowance  (105,059)  (165,210)
  $  $ 

Schedule of Deferred Tax Assets and Liabilities

  2023  2022 
  December 31, 
  2023  2022 
Deferred tax assets:        
Net operating loss carryforwards $74,752  $74,903 
Tax credit carryforwards  30,721   37,353 
Equipment, furnishings and other  7   19 
Total deferred tax assets  105,480   112,275 
Deferred tax liabilities      
Net deferred tax assets  105,480   112,275 
Valuation allowance  (105,480)  (112,275)
Deferred tax assets $  $ 

For all years presented, the Company did not recognize any deferred tax assets or liabilities. The net change in valuation allowance for the years ended December 31, 20172023 and 20162022 was $60.2$6.8 million and $21.4$3.9 million, respectively.

F-19
CytRx 2017 10-K Page # F-20#


The provision for income taxes differs from the provision computed by applying the Federal statutory rate to net loss before income taxes as follows (in thousands):

  Years ended December 31, 
  2017  2016  2015 
Federal benefit at statutory rate $(11,895) $(17,262) $(19,919)
State income taxes, net of Federal taxes  (2,073)  (3,086)  (3,556)
State credits  (506)  (1,031)  (1,324)
Warrant liabilities  (465)  (1,301)  (1,509)
Other permanent differences  11   40   16 
Provision related to change in valuation allowance  (60,358)  21,601   20,142 
Federal rate adjustment  27,314       
NQ Options  47       
Current year tax credit  (665)  (1,119)  (2,050)
NOL Adjustments  45,521       
Termination/Cancellation of Equity Compensation Awards  2,983   2,274   5,960 
Return to provision  84   (118)  2,238 
Other, net  3   3   3 
  $1  $1  $1 

Schedule of Effective Income Tax Rate Reconciliation

  2023  2022 
  Years ended December 31, 
  2023  2022 
Federal benefit at statutory rate $84 $(1,000)
State income taxes, net of Federal taxes  35  (333)
State credits      
Warrant liabilities      
Other permanent differences  (189)  261 
Provision related to change in valuation allowance  (7)  957 
Federal rate adjustment      
NQ Options      
Current year tax credit      
NOL Adjustments      
Termination/Cancellation of Equity Compensation Awards      
Return to provision  77   115 
Other, net      
Provision for Income taxes $  $ 

There have been no changes to the Company'sCompany’s liability for unrecognized tax benefits during the year ended December 31, 2017.

2023.

The Company files income tax returns in the U.S. Federal jurisdiction and various state jurisdictions. As of the year ended December 31, 2017,2023, the tax returns for 20132020 through 20172023 remain open to examination by the Internal Revenue Service and for 2019 to 2023 for various state tax authorities.

The Company'sCompany’s policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expense. As of the date of adoption of ASC 740 and the years ended December 31, 2017, 20162023 and 2015,2022, the Company had accrued no interest or penalties related to uncertain tax positions.

11. Commitments and Contingencies

Commitments

Aldoxorubicin

We have an agreement (the “Vergell Agreement”) with Vergell Medical (formerly with KTB Tumorforschungs GmbH) (“Vergell”) for the exclusive license of patent rights held by Vergell for the worldwide development and commercialization of aldoxorubicin. Under the agreement, we had to make payments to Vergell upon meeting certain clinical and regulatory milestones up to and including the product’s second final marketing approval. However, those payments are no longer required since the intellectual property acquired under the Vergell Agreement expired. We accrued $316,000 that we believe was owed prior to the expiry of the intellectual property. This amount was outstanding at December 31, 2023 and December 31, 2022.

Arimoclomol

The agreement relating to our worldwide rights to arimoclomol provides for our payment of up to an aggregate of $3.65 million upon receipt of milestone payments from Orphayzme A/S. On May 31, 2022, Orphazyme announced that it had completed the sale of substantially all of its assets and business activities for cash consideration of $12.8 million and assumption of liabilities estimated to equal approximately $5.2 million to KemPharm (the “KemPharm Transaction”). KemPharm is a specialty biopharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system (“CNS”) diseases. As part of the KemPharm Transaction, all of Orphazyme’s obligations to LadRx under the 2011 Arimoclomol Agreement, including with regard to milestone payments and royalties on sales, were assumed by KemPharm. KemPharm re-branded to Zevra Therapeutics, Inc. in February 2023.

F-20

16. Quarterly Financial Data (unaudited)
Summarized quarterly financial data

As discussed in Note 8, Assignment Agreement with XOMA, pursuant to the Assignment Agreement, although all the liabilities and obligations related to arimoclomol remain the responsibility of the Company, XOMA will direct an escrow agent appointed by them to pay on behalf of LadRx up to an aggregate of $3.25 million reflected in the preceding paragraph, as well as all future obligations related to Steven A. Kriegsman, pursuant to the Amended and Restated Employment Agreement, as amended by and between the Company and Mr. Kriegsman, dated March 26, 2019.

Innovive

Under the merger agreement by which we acquired Innovive Pharmaceuticals, Inc. (“Innovive”), we agreed to pay the former Innovive stockholders a total of up to approximately $18.3 million of future earnout merger consideration, subject to our achievement of specified net sales under the Innovive license agreements. As of December 31, 2023, there are no longer any further obligations due under this agreement, since the licensed intellectual property rights have expired.

Contractual obligations

LadRx’s current contractual obligations that will require future cash payments for 2017 and 2016 isthe following Employment Agreements as follows (in thousands, except per share data)thousands):

  Quarters Ended 
  March 31  June 30  September 30  December 31 
  (In thousands, except per share data) 
2017            
Total revenues $  $  $  $100 
Net loss $(11,044) $(14,358) $(5,124) $(4,460)
Basic and diluted loss per share applicable to common stock $(0.60) $(0.60) $(1.14) $(0.16)
                 
2016                
Total revenues $  $100  $  $100 
Net loss $(12,643) $(18,280) $(12,175) $(7,672)
Basic and diluted loss per share applicable to common stock $(1.14) $(1.62) $(0.78) $(0.48)

Quarterly

Schedule of Current Contractual Obligations

  

Employment Agreements

(1)

 
2024  963 
2025  963 
Thereafter   
Total $1,926 

(1)Employment agreements include management contracts which have been revised from time to time. The employment agreements for the Company’s executive officers provide for minimum salaries, which are adjusted annually at the discretion of the Company’s Compensation Committee, and in some cases provide for minimum annual bonuses and employee benefits, as well.

Contingencies

The Company is occasionally involved in legal proceedings and year-to-date loss per share amounts are computed independentlyother matters arising from the normal course of each other. Therefore,business. On November 30, 2022, Jerald Hammann (“Hammann”) filed a complaint (the “Complaint”) against the sumCompany, Mr. Caloz, and Mr. Kriegsman (together, “Defendants”) in the Court of Chancery of the per share amountsState of Delaware, alleging various violations of a Cooperation Agreement, dated August 21, 2020, by and between the Company and Hammann. The Complaint alleges breaches of a provision limiting the Board’s ability to effect discretionary compensation and a non-disparagement provision. The Complaint further alleges a breach of a purported implied obligation that the Company disclose various internal records to Hammann. Defendants believe the Complaint is wholly without merit and moved to dismiss the Complaint in its entirety. As a result, the Court subsequently dismissed the claims against Mr. Caloz and Mr. Kriegsman and also dismissed one of the claims against the Company. The Company intends to litigate vigorously against Hammann’s claims.

The Company intends to vigorously defend against any complaint. We have directors’ and officers’ liability insurance, which will be utilized, after the deductible, in the defense of any matter involving our directors or officers.

The Company evaluates developments in legal proceedings and other matters on a quarterly basis. If an unfavorable outcome becomes probable and reasonably estimable, we could incur charges that could have a material adverse impact on our financial condition and results of operations for the quarters may not agreeperiod in which the outcome becomes probable and reasonably estimable.

12. Subsequent Events

On September 7, 2023, the Board additionally approved and set January 16, 2024 as the grant date for certain stock options to purchase shares of common stock to certain directors and officers of the per share amounts forCompany. The total number of stock options granted was 55,000, 50% with immediate vesting, and the year.balance vesting on a monthly basis over three years.

F-21
CytRx 2017 10-K Page # F-21#




CYTRX CORPORATION
SCHEDULE II — VALUATION AND QUALIFYING ACCOUNTS
For the Years Ended December 31, 2017, 2016 and 2015

     
                 Additions
       
 
 
Description
 
Balance at
Beginning of Year
  
Charged to
Costs and
Expenses
  
Charged to Other
Accounts
  
Deductions
  
Balance at
End of Year
 
Reserve Deducted in the Balance Sheet from the Asset to Which it Applies:               
Allowance for Deferred Tax Assets               
Year ended December 31, 2017 $165,210,000  $  $(60,151,000) $  $105,059,000 
Year ended December 31, 2016 $143,609,000  $  $21,601,000  $  $165,210,000 
Year ended December 31, 2015 $123,466,000  $  $20,143,000  $  $143,609,000 
CytRx 2017 10-K Page # F-22#