COMMISSION FILE NUMBER 001-35558

Title of each class:

Trading Symbol(s)

Name of each exchange on which registered:

Common Stock

CRDF

Nasdaq Capital Market

Indicate by check mark whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x☒ No o☐

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, 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). Yes x☒ No o☐

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

Large accelerated filer ☐

Accelerated filer ☐

Non-accelerated filer ☒

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. o☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o☐ No x☒

As of October ~~31, 2017,~~29, 2021, the issuer had ~~38,106,460~~39,552,129 shares of Common Stock issued and outstanding.

~~TROVAGENE,~~CARDIFF ONCOLOGY, INC.


	Three Months Ended September 30,				Nine Months Ended September 30,
	2021		2020		2021		2020
Net loss	$	(6,913)	$	(4,497)	$	(18,849)	$	(12,710)
Other comprehensive income:
Unrealized gain on securities available-for-sale	26		—		16		—
Total comprehensive loss	(6,887)		(4,497)		(18,833)		(12,710)

Preferred stock dividend payable on Series A Convertible Preferred Stock	(6)		(6)		(18)		(18)


Deemed dividend recognized on beneficial conversion features of Series D Convertible Preferred Stock issuance	—		—		—		(602)
Deemed dividend recognized on beneficial conversion features of Series E Convertible Preferred Stock issuance	—		—		—		(2,665)

Comprehensive loss attributable to common stockholders	$	(6,893)	$	(4,503)	$	(18,851)	$	(15,995)

Three Months Ended September 30, Nine Months Ended September 30,
2017 2016 2017 2016
Net loss $ (4,291,966 ) $ (10,191,272 ) $ (22,337,314 ) $ (30,656,068 )
Other comprehensive income (loss):
Foreign currency translation loss (1,544 ) (81 ) (13,486 ) (1,877 )
Unrealized gain or reversal of previous losses on securities available-for-sale —
(7,997 ) 9,065
(2,865 )
Total other comprehensive income (loss) (1,544 ) (8,078 ) (4,421 ) (4,742 )

Total comprehensive loss (4,293,510 ) (10,199,350 ) (22,341,735 ) (30,660,810 )

Preferred stock dividend (6,060 ) (6,060 ) (18,180 ) (18,180 )

Comprehensive loss attributable to common stockholders $ (4,299,570 ) $ (10,205,410 ) $ (22,359,915 ) $ (30,678,990 )


	Preferred Stock Shares	Preferred Stock Amount		Common Stock Shares	Common Stock Amount		Additional Paid-In Capital		Service Receivable		Accumulated Other Comprehensive Income/(Loss)		Accumulated Deficit		Total Stockholders’ Equity
Balance, January 1, 2021	716	$	1	36,781	$	4	$	361,819	$	(2,171)	$	—	$	(231,495)	$	128,158
Stock-based compensation	—	—		—	—		268		—		—		—		268

Issuance of common stock upon exercise of warrants	—	—		771	—		1,263		—		—		—		1,263

Other comprehensive loss	—	—		—	—		—		—		(67)		—		(67)
Preferred stock dividend	—	—		—	—		—		—		—		(6)		(6)
Release of clinical trial funding commitment	—	—		—	—		—		380		—		—		380
Net loss	—	—		—	—		—		—		—		(5,179)		(5,179)
Balance, March 31, 2021	716	$	1	37,552	$	4	$	363,350	$	(1,791)	$	(67)	$	(236,680)	$	124,817
Stock-based compensation	—	—		—	—		1,036		—		—		—		1,036
Sale of common stock, net of expenses(1)	—	—		2,000	—		19,225		—		—		—		19,225
Other comprehensive gain	—	—		—	—		—		—		57		—		57
Preferred stock dividend	—	—		—	—		—		—		—		(6)		(6)
Release of clinical trial funding commitment	—	—		—	—		—		546		—		—		546
Net loss	—	—		—	—		—		—		—		(6,757)		(6,757)
Balance, June 30, 2021	716	$	1	39,552	$	4	$	383,611	$	(1,245)	$	(10)	$	(243,443)	$	138,918
Stock-based compensation	—	—		—	—		940		—		—		—		940
Other comprehensive gain	—	—		—	—		—		—		26		—		26
Preferred stock dividend	—	—		—	—		—		—		—		(6)		(6)
Release of clinical trial funding commitment	—	—		—	—		—		579		—		—		579
Net loss	—	—		—	—		—		—		—		(6,913)		(6,913)
Balance, September 30, 2021	716	$	1	39,552	$	4	$	384,551	$	(666)	$	16	$	(250,362)	$	133,544

(1)Net of expenses of $0.8 million.


	Preferred Stock Shares	Preferred Stock Amount		Common Stock Shares	Common Stock Amount		Additional Paid-In Capital		Service Receivable		Accumulated Other Comprehensive Income/(Loss)		Accumulated Deficit		Total Stockholders’ Equity
Balance, January 1, 2020	61	$	—	8,594	$	8	$	217,172	$	(972)	$	—	$	(208,898)	$	7,310
Stock-based compensation	—	—		—			177		—		—		—		177
Sale of common stock and warrants	—	—		800	—		1,000		—		—		—		1,000
Issuance of common stock upon exercise of warrants	—	—		1,610	—		1,456		—		—		—		1,456
Issuance of common stock upon vesting of restricted stock units	—	—		7	—		—		—		—		—		—
Preferred stock dividend	—	—		—	—		—		—		—		(6)		(6)
Release of clinical trial funding commitment	—	—		—	—		—		293		—		—		293
Net loss	—	—		—	—		—		—		—		(4,089)		(4,089)
Balance, March 31, 2020	61	$	—	11,011	$	8	$	219,805	$	(679)	$	—	$	(212,993)	$	6,141
Stock-based compensation	—	—		—	—		282		—		—		—		282
Issuance of common stock, preferred stock and warrants for clinical trial funding commitment	155	—		603	—		2,292		(2,300)		—		—		(8)
Deemed dividend recognized on beneficial conversion features of Series D Convertible Preferred Stock issuance	—	—		—	—		602		—		—		(602)		—
Deemed dividend recognized on beneficial conversion features of Series E Convertible Preferred Stock issuance	—	—		—	—		2,665		—		—		(2,665)		—
Sale of common stock, preferred stock and warrants(2)	866	1		4,689	1		17,277		—		—		—		17,279
Issuance of common stock upon exercise of warrants	—	—		3,473	—		4,605		—		—		—		4,605
Issuance of common stock upon vesting of restricted stock units	—	—		2	—		—		—		—		—		—
Issuance of common stock upon conversion of Series D Convertible Preferred Stock	(155)	—		1,547	—		—		—		—		—		—
Preferred stock dividend payable on Series A Convertible Preferred Stock	—	—		—	—		—		—		—		(6)		(6)
Release of clinical trial funding commitment	—	—		—	—		—		213		—		—		213
Net loss	—	—		—	—		—		—		—		(4,124)		(4,124)
Balance, June 30, 2020	927	$	1	21,325	$	9	$	247,528	$	(2,766)	$	—	$	(220,390)	$	24,382
Stock-based compensation	—	—		—	—		362		—		—		—		362
Issuance of common stock upon exercise of warrants	—	—		4,957	1		12,910		—		—		—		12,911
Issuance of common stock upon exercise of stock options	—	—		3	—		7		—		—		—		7
Issuance of common stock upon vesting of restricted stock units	—	—		1	—		—		—		—		—		—
Preferred stock dividend payable on Series A Convertible Preferred Stock	—	—		—	—		—		—		—		(6)		(6)


	Preferred Stock Shares	Preferred Stock Amount		Common Stock Shares	Common Stock Amount		Additional Paid-In Capital		Service Receivable		Accumulated Other Comprehensive Income/(Loss)		Accumulated Deficit		Total Stockholders’ Equity
Release of clinical trial funding commitment	—	—		—	—		—		362		—		—		362
Net loss	—	—		—	—		—		—		—		(4,497)		(4,497)
Balance, September 30, 2020	927	$	1	26,286	$	10	$	260,807	$	(2,404)	$	—	$	(224,893)	$	33,521

(2)Net of expenses of $0.6 million, and fair value of warrants issued as a transaction advisory fee as of the date of issuance of $0.4 million.

See accompanying notes to the unaudited condensed ~~consolidated~~ financial statements.

CARDIFF ONCOLOGY, INC.

Business Organization and Overview

~~Trovagene,~~Cardiff Oncology, Inc. (“~~Trovagene”~~Cardiff Oncology” or the “Company”) headquartered in San Diego, California, is a clinical-stage oncology company with the mission of developing new precision medicine ~~oncology therapeutics company.~~treatment options for cancer patients in indications with the greatest unmet medical need, including KRAS-mutated metastatic colorectal cancer, metastatic pancreatic cancer and metastatic castration-resistant prostate cancer. The ~~Company’s primary focus~~Company's common stock is ~~to develop oncology therapeutics for improved cancer care, optimizing drug development by leveraging its proprietary Precision Cancer Monitoring® (“PCM”) diagnostic technology in tumor genomics.~~

Trovagene’s lead drug candidate, PCM-075, is a Polo-like Kinase 1 (“PLK1”) selective adenosine triphosphate (“ATP”) competitive inhibitor. PCM-075 has shown preclinical antitumor activity as a single agent and synergy in combination with more than ten different chemotherapeutics and targeted therapies, such as Zytiga® (abiraterone acetate), Beleodaq® (belinostat), Quizartinib (AC220), a development stage FLT3 inhibitor, and Velcade® (bortezomib) in Acute Myeloid Leukemia (“AML”), metastatic Castration-Resistant Prostate Cancer (“mCRPC”) and other liquid and solid tumor cancers.

PCM-075 was developed to have high selectivity to PLK1, to be administered orally, and to have a relatively short drug half-life of approximately 24 hours compared to other PLK inhibitors. PCM-075 has completed a safety study in patients with advanced metastatic solid tumors with a phase 1b/2 clinical trial in patients with AML underway.listed on the Nasdaq Capital Market under the ticker symbol "CRDF".

Basis of Presentation

The accompanying unaudited interim condensed ~~consolidated~~ financial statements of ~~Trovagene, which include all accounts of its wholly owned subsidiary, Trovagene, Srl,~~Cardiff Oncology have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”)~~. All intercompany balances and transactions have been eliminated.~~

~~The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with GAAP~~ and the rules and regulations of the Securities and Exchange Commission (“SEC”) related to a quarterly report on Form 10-Q. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations. The unaudited interim condensed ~~consolidated~~ financial statements reflect all adjustments consisting of normal recurring adjustments which, in the opinion of management, are necessary for a fair statement of the Company’s financial position and the results of its operations and cash flows for the periods presented. The unaudited condensed balance sheet at December 31, ~~2016~~2020 has been derived from the audited financial statements at that date but does not include all of the information and disclosures required by GAAP for annual financial statements. The operating results presented in these unaudited interim condensed ~~consolidated~~ financial statements are not necessarily indicative of the results that may be expected for any future periods. These unaudited interim condensed ~~consolidated~~ financial statements should be read in conjunction with the audited ~~consolidated~~ financial statements and the notes thereto for the year ended December 31, ~~2016~~2020 included in the Company’s annual report on Form 10-K filed with the SEC on ~~March 15, 2017.~~February 25, 2021.

Trovagene’s condensed consolidated financial statements as of September 30, 2017 have been prepared under the assumption that Trovagene will continue as a going concern, which assumes that the Company will realize its assets and satisfy its liabilities in the normal course of business. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty concerning the Company’s ability to continue as a going concern.

~~However, the~~ Company has incurred net losses since its inception and has negative operating cash flows. ~~The~~As of September 30, 2021, the Company ~~also received a default letter from Silicon Valley Bank (“SVB”) regarding~~had $134.0 million in cash, cash equivalents and short-term investments and believes it has sufficient cash to meet its funding requirements for at least the ~~Loan and Security Agreement entered in November 2015 which stated that events~~next 12 months following the issuance date of ~~default had occurred and SVB will decide in its sole discretion whether or not to exercise rights and remedies. Based on its current business plan and assumptions,~~these financial statements.

For the foreseeable future, the Company expects to continue to incur ~~significant~~ losses and require ~~significant~~ additional capital to further advance its clinical trial programs and support its other operations. Considering the Company’s current cash resources, including the net proceeds received from the offering of its equity securities in July 2017, management believes the Company’s existing resources will be sufficient to fund the Company’s

The Company cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that the Company can raise additional funds by issuing equity securities, the Company’s stockholders may experience ~~significant~~additional dilution. ~~Any debt financing, if available, may involve restrictive covenants that impact~~The economic effects of COVID-19 could also have an adverse effect on the ~~Company’s~~Company's ability ~~to conduct its business.~~

~~If the Company is unable~~ to raise additional ~~capital when required or on acceptable terms, it may have~~capital. See Note 10 to ~~significantly delay, scale back or discontinue~~ the ~~development and/or commercialization of one or more of its product candidates, all of which may have a material adverse impact on the Company’s operations. The Company may also be required to:~~condensed financial statements for further information.

~~Seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; and~~

~~The Company is evaluating the following options to raise additional capital, increase revenue, as well as reduce costs, in an effort to strengthen its liquidity position:~~

On October 25, 2017, the Company filed a registration statement on Form S-1 with the SEC for a best efforts public offering of up to $17.5 million of common stock and warrants. The Company continually assesses any spending plans, including a review of its discretionary spending in connection with certain strategic contracts, to effectively and efficiently address its liquidity needs.

On September 5, 2017, the Company received a written notice from the NASDAQ Stock Market LLC (“NASDAQ”) that it was not in compliance with NASDAQ Listing Rule 5550(a)(2) for continued listing on the NASDAQ Capital Market, as the minimum bid price of the Company’s common stock had been below $1.00 per share for 30 consecutive business days. In accordance with NASDAQ Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days, or until March 5, 2018, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Company’s common stock must meet or exceed $1.00 per share for at least ten consecutive business days during this 180 calendar day period.

~~Use~~During the nine months ended September 30, 2021, there have been no changes to the Company’s significant accounting policies as described in its Annual Report on Form 10-K for the fiscal year ended December 31, 2020, other than the addition of ~~Estimates~~investment securities as described below.

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.Investment Securities

~~Short-Term Investments~~

~~Short-term~~All investments consisted of corporate debt securities, U.S. treasury securities, and commercial paper. The Company classified its short-term investments as available-for-sale, as the sale of such securities may be required prior to maturity to execute management strategies. Investmentshave been classified as ~~available-for-sale~~“available-for-sale” and are carried at fair value as determined based upon quoted market prices or pricing models for similar securities at period end. Investments with contractual maturities less than 12 months at the balance sheet date are considered short-term investments. Investments with contractual maturities beyond one year are also classified as short-term due to the Company’s ability to liquidate the investment for use in operations within the next 12 months.

Realized gains and losses on investment securities are included in earnings and are derived using the specific identification method for determining the cost of securities sold. The Company has not realized any significant gains or losses on sales of available-for-sale investment securities during any of the periods presented. As all the Company’s investment holdings are in the form of debt securities or certificates of deposit, unrealized gains and losses that are determined to be temporary in nature are reported as a component of ~~consolidated~~ accumulated other comprehensive ~~income (loss) in stockholders’ equity until realized. Realized gains and losses from the sale of available-for-sale securities were determined on a specific identification basis.~~income. A decline in the ~~market~~fair value of any ~~available-for-sale~~ security below cost that is ~~determined to be~~deemed other than temporary ~~will result~~results in ~~an impairment~~a charge to earnings and the establishment of a new cost basis for the security is established. No such impairment charges were recorded for any period presented. Premiums and discounts were amortized or accreted over the life of the related security as an adjustment to yield using the straight-line method and included in interest income.security. Interest income was recognized when earned. Realized gains and losses on investments in securities were included in other income (loss) within the consolidated statements of operations. As of September 30, 2017, all of the short-term investments have been sold to satisfy the Company’s outstanding obligations under the Loan and Security Agreement dated as of June 30, 2014 upon demanding repayment by the lenders. As a result, the Company recognized net realized loss of approximately $6,400 for the nine months ended September 30, 2017.

~~Revenue Recognition~~

~~Revenue~~ is recognized when ~~persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed or determinable, and collection is reasonably assured.~~

~~Milestone, Royalty and License Revenues~~

The Company licenses and sublicenses its patent rights to healthcare companies, medical laboratories and biotechnology partners. These agreements may involve multiple elements such as license fees, royalties and milestone payments. Revenue is recognized when the criteria described above have been met as well as the following:

•Up-front nonrefundable license fees pursuant to agreements under which the Company has no continuing performance obligations are recognized as revenues on the effective date of the agreement and when collection is reasonably assured.

•~~Minimum royalties are recognized as~~ earned and ~~royalties~~is included in investment income, as are ~~earned based~~the amortization of purchase premiums and accretion of purchase discounts on the licensee’s use. The Company is unable to predict licensee’s sales and thus revenue is recognized upon receipt of notification from licensee and payment when collection is assured. Notification is generally one quarter in arrears.investment securities.

•~~Milestone payments are recognized when both the milestone is achieved and the related payment is received.~~

~~Diagnostic Service Revenues~~

Revenue for clinical laboratory tests may come from several sources, including commercial third-party payors, such as insurance companies and health maintenance organizations, government payors, such as Medicare and Medicaid in the United States, patient self-pay and, in some cases, from hospitals or referring laboratories who, in turn, might bill third-party payors for testing. The Company is recognizing diagnostic service revenue on the cash collection basis until such time as it is able to properly estimate collections on third party reimbursements.

~~Clinical Research Services Revenue~~

Revenue from clinical research services consists of revenue from the sale of urine and blood collection supplies and tests performed under agreements with our clinical research and business development partners. Revenue was recognized when supplies and/or test results were delivered.

Cost of revenue represents the cost of materials, personnel costs and costs associated with processing specimens including pathological review, quality control analyses, and delivery charges necessary to render an individualized test result. Costs associated with performing tests are recorded as the tests are processed. However, the revenue on diagnostic services is recognized on a cash collection basis resulting in costs incurred before the collection of related revenue.

~~Derivative Financial Instruments—Warrants~~

The Company has issued common stock warrants in connection with the execution of certain equity financings. Such warrants are classified as derivative liabilities under the provisions of Financial Accounting Standards Board (“FASB”) ASC 815 ~~Derivatives and Hedging~~ ~~(“ASC 815”) or ASC 480 Distinguishing Liabilities from Equity (“ASC 480”)~~are recorded at their fair market value as of each reporting period. Such warrants do not meet the exemption that a contract should not be considered a derivative instrument if it is (1) indexed to its own stock and (2) classified in stockholders’ equity. The warrants within the scope of ASC 480 contain a feature that could require the transfer of cash in the event a change of control occurs without an authorization of our Board of Directors, and therefore classified as a liability. Changes in fair value of derivative liabilities are recorded in the consolidated statement of operations under the caption “Change in fair value of derivative instruments.”

The fair value of warrants is determined using the Black-Scholes option-pricing model using assumptions regarding the volatility of Trovagene’s common stock price, the remaining life of the warrants, and the risk-free interest rates at each period end. The Company thus uses model-derived valuations where inputs are observable in active markets to determine the fair value and accordingly classifies such warrants in Level 3 per FASB ASC Topic 820, ~~Fair Value Measurements~~ (“ASC 820”). At September 30, 2017 and December 31, 2016, the fair value of these warrants was $2,037,712 and $834,940, respectively, and was recorded as a liability under the caption “derivative financial instruments—~~warrants” on the consolidated balance sheets.~~

Basic and diluted net loss per ~~share is presented in conformity with ASC Topic 260,~~ ~~Earnings per Share, for all periods presented. In accordance with this guidance, basic net loss per~~ common share ~~was~~is determined by dividing net loss applicable to common stockholders by the weighted-average common shares outstanding during the period. Preferred dividends are included in ~~income available~~net loss attributable to common stockholders in the computation of basic and diluted earnings per share. Diluted net loss per share is computed by dividing the net loss by the weighted average number of common shares and common share equivalents outstanding for the period. Common share equivalents are only included when their effect is dilutive.

~~The following table sets forth the computation of basic and diluted earnings per share:~~

Adjustment for gain from change in fair value of derivative financial instruments—warrants

The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because their effect was anti-dilutive:

September 30,
2017 2016
Options to purchase Common Stock 4,257,031
6,051,186
Warrants to purchase Common Stock 8,972,503
4,546,939
Restricted Stock Units 1,277,302
392,000
Series A Convertible Preferred Stock 63,125
63,125
14,569,961
11,053,250

The Company expenses amounts paid to acquire licenses associated with products under development when the ultimate recoverability of the amounts paid is uncertain and the technology has no alternative future use when acquired. Acquisitions of technology licenses are charged to expense or capitalized based upon management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. The Company has determined that technological feasibility for its product candidates is reached when the requisite regulatory approvals are obtained to make the product available for sale.

~~Restructuring costs are included in loss from operations in the condensed consolidated statements of operations. The Company has accounted for these costs in accordance with ASC Topic 420,~~ ~~Exit or DisposalCost Obligations~~. One-time termination benefits are recorded at the time they are communicated to the affected employees. In March 2017, the Company announced a restructuring plan which is expected to be completed in the last quarter of 2017. See Note 10 to the condensed consolidated financial statements for further information.

Recent Accounting ~~Pronouncements~~Pronouncement Not Yet Adopted

In August ~~2016,~~2020, the FASB issued ~~Accounting Standards Update (“ASU”) 2016-15,~~ ~~Classification of Certain Cash Receipts and Cash Payments~~ (“ASU ~~2016-15”~~No. 2020-06 ("ASU 2020-06"), ~~which includes amendments that clarify how certain cash receipts~~Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). ASU 2020-06 eliminates the beneficial conversion and cash ~~payments~~conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are ~~presented~~currently accounted for as derivatives because of specific settlement provisions. In addition, ASU 2020-06 modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the ~~statement of cash flows. ASU 2016-15 also provides guidance clarifying when an entity should~~

In ~~February 2016,~~May 2021, the FASB issued ASU ~~2016-02,~~ ~~Leases~~No. 2021-04 ("ASU 2021-04), Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the FASB Emerging Issues Task Force). The ~~new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet~~amendments in this update are effective for ~~most leases. The new standard is effective~~all entities for fiscal years beginning after December 15, ~~2018,~~2021, including interim periods within those fiscal years. A modified retrospective transition approach is required for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The ~~new standard will impact the Company’s accounting for its office leases and the~~ Company is currently evaluating the impact of ~~the new~~this standard ~~on its consolidated financial statements.~~

~~In May 2014, the FASB issued ASU 2014-09,~~ ~~Revenue from Contracts with Customers~~ (“ASU 2014-09”). The new standard is based on the principle that revenue should be recognized to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Since its initial release, the FASB has issued several amendments to the standard, which include clarification of accounting guidance related to identification of performance obligations, intellectual property licenses, and principle versus agent considerations. ASU 2014-09 and all subsequent amendments (collectively, the “new standards”) will be effective for the Company beginning in the first quarter of fiscal year 2018 and may be applied using either the full retrospective method, in which case the new standards would be applied to each prior reporting period presented, or the modified retrospective method, in which case the cumulative effect of applying the new standards would be recognized at the date of initial application. The Company has reviewed its revenue streams to identify potential differences in accounting as a result of the new standards. Currently, the Company does not have any significant contracts with customers given its stage of development. The Company has derived its revenues primarily from a limited number of royalty, license and diagnostic service agreements. The consideration the Company is eligible to receive under these agreements includes upfront license payments, milestone payments and royalties. Each of these agreements has unique terms that are being evaluated separately under the new standards. The new standards differ from the current accounting standard in many respects, such as in the accounting for variable consideration, including milestone payments. For example, the Company currently recognizes milestone revenue using the milestone method specified in ASC 605-28, which generally results in recognition of milestone revenue in the period that the milestone event is achieved. However, under the new standards, it is possible to start to recognize milestone revenue before the milestone is achieved if management determines with a high degree of certainty that amounts recorded as revenues will not have to be reversed when the uncertainty associated with the variable consideration is subsequently resolved. The Company is also continuing to assess the potential impact that the new standards may have with respect to its diagnostic service revenue which is currently recognized on a cash collection basis. Under the new standards, the Company may recognize diagnostic service revenue upon delivery of test results if management determines with a high degree of certainty that amounts recorded as revenues will not have to be reversed when the uncertainty associated with the variable consideration is subsequently resolved. The Company is continuing to assess the impact the new standards will have on its financial statements and ~~expects to complete the assessment on or before the year-end 2017. The Company does not expect a significant change in the timing and recognition~~related disclosures.

Table of its revenue upon adoption of the new standards. The Company expects to adopt the new standards using the modified retrospective method with an adjustment, if any, to beginning retained earnings for the cumulative effect of the change.Contents

3. Fair Value Measurements

The following table presents the Company’s assets and liabilities that are measured and recognized at fair value on a recurring basis classified under the appropriate level of the fair value hierarchy as of September 30, ~~2017~~2021 and December 31, ~~2016:~~2020:


	Fair Value Measurements at September 30, 2021
(in thousands)	Quoted Prices in Active Markets for Identical Assets and Liabilities (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Total
Assets:
Money market fund	$	12,650	$	—	$	—	$	12,650

Total included in cash and cash equivalents (1)	$	12,650	$	—	$	—	$	12,650

Available for sale investments:
Certificate of deposit	—		2,610		—		2,610
Corporate debt securities	—		77,910		—		77,910
Commercial paper	—		12,436		—		12,436
Non U.S. government	—		732		—		732
U.S. treasury securities	27,194		—		—		27,194
Total available for sale investments (2)	$	27,194	$	93,688	$	—	$	120,882

Total assets measured at fair value on a recurring basis	$	39,844	$	93,688	$	—	$	133,532
Liabilities:
Derivative financial instruments—warrants (3)	$	—	$	—	$	5	$	5
Total liabilities measured at fair value on a recurring basis	$	—	$	—	$	5	$	5

Fair Value Measurements at
September 30, 2017

Quoted Prices in Active Markets for Identical Assets and Liabilities
(Level 1)

Significant Other Observable Inputs
(Level 2)

Significant Unobservable Inputs
(Level 3)
Total
Assets:
Money market fund (1) $ 6,510,214
$ —
$ —
$ 6,510,214
Total Assets $ 6,510,214
$ —
$ —
$ 6,510,214
Liabilities:
Derivative financial instruments—warrants
$ —
$ —
$ 2,037,712
$ 2,037,712
Total Liabilities $ —
$ —
2,037,712
$ 2,037,712

Fair Value Measurements at
December 31, 2016

Quoted Prices in Active Markets for Identical Assets and Liabilities
(Level 1)

Significant Other Observable Inputs
(Level 2)

Significant Unobservable Inputs
(Level 3)
Total
Assets:
Money market fund (1) $ 12,095,620
$ —
$ —
$ 12,095,620
Corporate debt securities (2) —
14,160,686
—
14,160,686
Commercial paper (3) —
2,393,948
—
2,393,948
U.S. treasury securities (2) —
8,621,892
—
8,621,892
Total Assets $ 12,095,620
$ 25,176,526
$ —
$ 37,272,146
Liabilities:
Derivative financial instruments—warrants
$ —
$ —
$ 834,940
$ 834,940
Total Liabilities $ —
$ —
$ 834,940
$ 834,940


	Fair Value Measurements at December 31, 2020
(in thousands)	Quoted Prices in Active Markets for Identical Assets and Liabilities (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Total
Assets:
Money market fund (1)	$	129,988	$	—	$	—	$	129,988



Total assets measured at fair value on a recurring basis	$	129,988	$	—	$	—	$	129,988
Liabilities:
Derivative financial instruments—warrants (3)	$	—	$	—	$	285	$	285
Total liabilities measured at fair value on a recurring basis	$	—	$	—	$	285	$	285

(1) Included as a component of cash and cash equivalents on the accompanying condensed ~~consolidated~~ balance sheets. Cash equivalents are considered by the Company to be highly liquid investments purchased with original maturities of three months or less from the date of purchase.

(2) Included in short-term investments onin the accompanying condensed ~~consolidated~~ balance sheets.

(3) $0 and $1,198,504 of commercial paper was included as a component of cash and cash equivalents at September 30, 2017 and December 31, 2016, respectively, and the remaining amount was included in short-term investments on the accompanying consolidated balance sheets.

~~The following table sets forth a summary of changes in the fair value of the Company’s Level 3 liabilities for the nine months ended September 30, 2017:~~

Description Balance at
December 31, 2016 Issuance of Derivative Financial Instruments
Realized
Gain
Balance at
September 30, 2017
Derivative financial instruments—warrants
$ 834,940
3,215,519
$ (2,012,747 ) $ 2,037,712

The realized gains or losses on the derivative financial instruments—warrants are recorded as a change in fair value of derivative financial instruments—warrants in the Company’s consolidated statement of operations. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. At each reporting period, ~~the Company reviews the assets and liabilities that are subject to ASC Topic 815-40. At each reporting period,~~ all assets and liabilities for which the fair value

Table of Contents

measurement is based on significant unobservable inputs or instruments that trade infrequently and therefore have little or no price transparency are classified as Level 3. See Note 6 to the condensed financial statements for further information.

4. ~~Short-Term Investments~~Supplementary Balance Sheet Information

AsInvestments available for sale consist of ~~September 30, 2017, all short-term investments have been sold to satisfy~~ the ~~Company’s outstanding obligations under the Loan and Security Agreement dated as of June 30, 2014 upon demanding repayment by the lenders.~~following:

~~The following table sets forth the composition of short-term investments as of December 31, 2016.~~


	As of September 30, 2021
(in thousands)	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Fair Market Value
Certificate of deposit	$	2,609	$	1	$	—	$	2,610
Corporate debt securities	77,901		15		(6)		77,910
Commercial paper	12,434		4		(2)		12,436
Non U.S. government	732		—		—		732
U.S. treasury securities	27,190		5		(1)		27,194
Total short term investments	$	120,866	$	25	$	(9)	$	120,882

December 31, 2016
Unrealized
Maturity in Years Cost Gains Losses Fair Value
Corporate debt securities Less than 1 year $ 14,165,915
$ 44
$ (5,273 ) $ 14,160,686
Commercial paper Less than 1 year 1,195,444
—
—
1,195,444
U.S. treasury securities Less than 1 year 8,625,728
330
(4,166 ) 8,621,892
Total Investment $ 23,987,087
$ 374
$ (9,439 ) $ 23,978,022

~~5. Property and Equipment~~

Property and equipment consist of the following:


	As of September 30, 2017			As of December 31, 2016
(in thousands)							(in thousands)	As of September 30, 2021		As of December 31, 2020
Furniture and office equipment	$	1,076,709		$	1,144,741		Furniture and office equipment	$	866	$	798
Leasehold improvements	1,994,514			1,994,514			Leasehold improvements	1,962		1,962
Laboratory equipment	2,584,363			2,449,645			Laboratory equipment	884		868
	5,655,586			5,588,900				3,712		3,628
Less—accumulated depreciation and amortization	(2,528,617		)	(1,761,985		)	Less—accumulated depreciation and amortization	(3,329)		(3,004)
Property and equipment, net	$	3,126,969		$	3,826,915		Property and equipment, net	$	383	$	624

As a lessee, the Company’s current leases include its master facility lease and immaterial equipment leases, all of which are considered operating leases.

The Company (as a sublessor) also subleases portions of ~~Credit~~its facility to third parties under 3 separate subleases. All of these subleases have been determined to be operating leases and are accounted for separately from the head lease.

~~In November 2015,~~Master Facility Lease

The Company currently occupies 9,500 square feet of office and lab space in San Diego. During July 2021, the Company entered into ~~a Loan~~an amended lease agreement to increase its occupied space to 12,300 square feet which commences on January 1, 2022 and ~~Security Agreement (“Equipment Line of Credit”) with SVB that provided for cash borrowings for equipment (“Equipment Advances”) of up to $2.0 million, secured by the equipment financed.~~expires on February 28, 2027. Under the ~~terms~~current master facility lease, which expires on December 31, 2021, the Company leases 26,100 square feet of office and lab space. This includes 16,600 square feet of space that is subleased to third parties, all of which expires on December 31, 2021. The minimum monthly rent under the ~~agreement, interest~~amended lease is ~~equal to 1.25% above the Prime Rate. At September 30, 2017, the interest rate was 5.50%. Interest only~~$55,000 with an annual rent escalation of 3% per year beginning on January 1, 2022. Through December 31, 2021 rent payments are ~~due~~approximately $80,000 per month.

As a result of corporate restructurings in previous years, the Company vacated a portion of its facility and has subleased the space to third parties under 3 separate sublease agreements, which all expire on ~~borrowings through November 30, 2016, with both interest and principal payments commencing in~~ December ~~2016. All unpaid principal and interest on each Equipment Advance will be due on November 1, 2019.~~31, 2021. The Company has an obligation to make a final payment equal to 7% of total amounts borrowed at the loan maturity date. The Company is also subject to certain affirmative and negative covenants under the Equipment Line of Credit.

On June 20, 2017, the Company received a Notice of Event of Default (“Default Letter”) from SVB which stated that Events of Default had occurred and SVB will decide in its sole discretion whether or not to exercise rights and remedies. Pursuant to the Default Letter, the Company has classified the entire balance of $1,488,041 as a ~~current liability~~sublessor is leasing approximately 16,600 square feet of space to third parties as of September 30, ~~2017 and also started recording accrued interest at a default rate.~~ 2021.

The ~~Company recorded $209,082 in interest~~components of lease expense were as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2021		2020		2021		2020
Operating lease cost	$	281	$	99	$	468	$	345
Operating sublease income	(101)		(73)		(303)		(218)
Net operating lease cost	$	180	$	26	$	165	$	127

Supplemental balance sheet information related to ~~the Equipment Line of Credit during the nine months ended September 30, 2017. The Company is currently working with lender~~leases was as follows:


(in thousands)	As of September 30, 2021			As of December 31, 2020
Operating lease ROU assets	$	3,017		$	343

Current operating lease liabilities	$	594		$	860
Non-current operating lease liabilities	2,691			9
Total operating lease liabilities	$	3,285		$	869

Weighted-average remaining lease term–operating leases	5.3 years			1.0 year
Weighted-average discount rate–operating leases	7.0		%	6.5		%

Supplemental cash flow and other information related to leases was as follows:

Total remaining annual commitments under non-cancelable lease agreements for ~~resolution.~~

~~Loan and Security Agreement~~

In June 2014, the Company entered into a $15,000,000 Loan and Security Agreement (“Agreement”) under which the lenders provided the Company a term loan. On July 20, 2016, the Company signed the 5th Amendment to Loan and Security Agreement to refinance its existing term loan. Under the Amendment, interest is equal to 3.75% plus the Wall Street Journal Prime Rate, subject to a floor of 7.25%. The Company is required to make interest only payments on the outstanding amounteach of the ~~loan on a monthly basis through September 1, 2017, after which equal monthly payments~~years ended December 31 are as follows:


(in thousands)
Year Ending December 31,	Operating Leases		Sublease Income		Net Operating Leases

2021 (excluding the nine months ended September 31, 2021)	$	163	$	(101)	$	62
2022	610		—		610
2023	737		—		737
2024	754		—		754
2025	775		—		775

Thereafter	933		—		933
Total future minimum lease payments	3,972		$	(101)	$	3,871
Less imputed interest	(687)
Total	$	3,285

On June 1, 2017, the Company received a Notice of Event of Default from the lenders which stated that Events of Default had occurred and all of the obligation under the Agreement were immediately due and payable. On June 6, 2017, the lenders took the total pay-off amount of $16,668,583 for the principal, interest, final payment, and other amounts out of the Company’s bank accounts which satisfied all of the Company’s outstanding obligations under the Agreement. Accordingly, the Agreement was terminated in June 2017. Upon termination of the Agreement, the prepayment fee of $450,000, unamortized debt discount of $400,562 and unamortized final fee of $738,196 were recorded as loss on debt extinguishment. The Company recorded total interest expense of $801,173 related to the Agreement during the nine months ended September 30, 2017.

Based upon the Company’s analysis of the criteria contained in ASC Topic 815-40, Contracts in Entity’s Own Equity (“ASC 815-40”) or ASC Topic 480-10, Distinguishing Liabilities from Equity (“ASC 480-10”), ~~Trovagene~~Cardiff Oncology determined that certain warrants issued in connection with the execution of certain equity financings must be recorded as derivative liabilities. In accordance with ASC 815-40 and ASC 480-10, the warrants are also being re-measured at each balance sheet date based on estimated fair value, and any resultant change in fair value is being recorded in the Company’s condensed ~~consolidated~~ statements of operations. The Company estimates the fair value of these warrants using the Black-Scholes option pricing model.

The ~~range of~~ assumptions used to determine the fair value of the warrants ~~valued~~ using the Black-Scholes option pricing model ~~during the periods indicated was:~~were:

Nine Months Ended September 30,
2017 2016
Estimated fair value of Trovagene common stock 0.73-1.26
4.49-4.65
Expected warrant term 1.3-5.5 years
2.3-2.8 years
Risk-free interest rate 1.27-1.95%
0.71-0.87%
Expected volatility 86-109%
82-89%
Dividend yield 0 % 0 %

Expected volatility is based on historical volatility of ~~Trovagene’s~~Cardiff Oncology’s common stock. The warrants have a transferability provision, ~~and based on guidance provided in Staff Accounting Bulletin (“SAB”) No. 107,~~ ~~Share-Based Payment~~ ~~(“SAB No. 107”)~~, ~~for instruments issued with such a provision, Trovagene~~accordingly, Cardiff Oncology used the remaining contractual term as the expected term of the warrants. The ~~risk free~~risk-free rate is based on the U.S. Treasury security rates consistent with the expected remaining term of the warrants at each balance sheet date.

The following table sets forth the components of changes in the Company’s derivative financial instruments—warrants liability balance, valued using the Black-Scholes option pricing method, for the periods indicated.

Balance of derivative financial instruments—warrants liability

Change in fair value of derivative financial instruments—warrants during the period recognized as a gain in the condensed consolidated statements of operations

Balance of derivative financial instruments—warrants liability

Change in fair value of derivative financial instruments—warrants during the period recognized as a gain in the condensed statements of operations

Balance of derivative financial instruments—warrants liability

During the nine months ended September 30, 2017, the Company issued a total of 7,408,460 shares of Common Stock. The Company received gross proceeds of approximately $7.1 million from the sale of 6,191,500 shares of its common stock and 4,643,626 share of warrants through registered direct offering and private placement in July 2017. The Company received gross proceeds of approximately $0.1 million from the sale of 102,081 shares of its common stock at a weighted average price of $1.08 under the agreement with Cantor Fitzgerald & Co. (“Agent”). In addition, 369,487 shares were issued upon vesting of restricted stock units (“RSU”), and 745,392 shares were issued upon vesting of restricted stock awards (“RSA”).

Stock-based compensation expense related to ~~Trovagene~~Cardiff Oncology equity awards have been recognized in operating results as ~~follow:~~follows:

The unrecognized compensation cost related to non-vested stock options outstanding at September 30, ~~2017 and 2016,~~2021, net of ~~expected~~estimated forfeitures, was ~~$3,271,046 and $10,416,565, respectively,~~$10.1 million, which is expected to be recognized over a weighted-average remaining vesting period of ~~2.2 and 3.0 years, respectively.~~3.3 years. The weighted-average remaining contractual term of outstanding options as of September 30, ~~2017~~2021 was

approximately ~~7.2~~8.9 years. The total fair value of stock options vested during the nine months ended September 30, ~~2017~~2021 and ~~2016 was $3,378,243~~2020 were $1.2 million and ~~$5,416,168,~~$0.8 million, respectively.

The estimated fair value of stock option awards was determined on the date of grant using the Black-Scholes option valuation model with the following weighted-average assumptions during the following periods indicated:

Nine Months Ended
September 30,
2017 2016
Risk-free interest rate 1.82 % 1.48 %
Dividend yield 0 % 0 %
Expected volatility 87 % 103 %
Expected term 5.2 years
5.5 years

A summary of stock option activity and changes in stock options outstanding is presented below:

On2021 Equity Incentive Plan

In June ~~13, 2017,~~2021 the Company's stockholders approved the 2021 Omnibus Equity Incentive Plan ("2021 Plan"). The number of authorized shares in the ~~Trovagene~~2021 plan is equal to the sum of (i) 3,150,000 shares, plus (ii) the number of shares of Common Stock reserved, but unissued under the 2014 ~~Equity Incentive Plan (“~~Plan; and (iii) the number of shares of Common Stock underlying forfeited awards under the 2014 ~~EIP”) was increased from 7,500,000 to 9,500,000.~~Plan. As of September 30, ~~2017~~2021, there were ~~3,670,232~~2,289,902 shares available for issuance under the 2021 Plan.

2014 ~~EIP.~~Equity Incentive Plan

~~Restricted Stock Units~~

~~The weighted-average grant date fair value~~Subsequent to the adoption of the ~~RSU was $1.59~~2021 Plan, no additional equity awards can be made under the terms of the 2014 Plan.

In July 2021, the Company began issuing equity awards to certain new employees as inducement grants outside of its 2021 Plan. As of September 30, 2021, an aggregate of 590,000 shares were issuable upon the exercise of inducement grant stock options approved by the Company.

Modification of Stock Options

In June 2021 two of the Company's directors' terms ended. At the conclusion of their term, the Compensation Committee passed a resolution to extend the expiration date of the departing directors vested stock options, and ~~$4.06 per share~~to immediately accelerate the vesting of one of the directors unvested options. The Company recorded incremental stock compensation expenses of$0.6 million during the nine months ended September 30, ~~2017 and 2016, respectively.~~2021, related to the modifications.

Restricted Stock Units

A summary of the RSU activity is presented below:

Number of Shares
Weighted-Average
Grant Date Fair Value
Per Share
Intrinsic Value
Non-vested RSU outstanding, December 31, 2016 272,000
$ 3.99
$ 571,200
Granted 2,249,242
$ 1.59

Vested (369,487 ) $ 3.48
$ 645,775
Forfeited (874,453 ) $ 1.75

Non-vested RSU outstanding, September 30, 2017 1,277,302
$ 1.44
$ 932,430

~~At September 30, 2017, total unrecognized compensation cost related to non-vested RSU was $1,011,494, which is expected to be recognized over a weighted-average period of 2.5 years.~~ The total fair value of vested ~~RSU~~RSUs during the nine months ended September 30, ~~2017 was $1,285,578.~~2021 and 2020 were $0.1 million and $0.1 million, respectively.

~~Restricted Stock Awards~~

During the nine months ended September 30, 2017, a total of 745,392 shares of RSA were granted, all of which were vested immediately. The total fair value of vested RSA during the nine months ended September 30, 2017 was $596,314. The weighted-average grant date fair value of the RSA was $0.80 per share during the nine months ended September 30, 2017. There were no such awards granted during the nine months ended September 30, 2016.

A summary of warrant activity and changes in warrants outstanding, including both liability and equity classifications is presented below:

A summary of our Company's classes of preferred stock is presented below:


						Shares outstanding
Class	Par value		Shares designated	Liquidation preference		As of September 30, 2021	As of December 31, 2020
Series A Convertible Preferred Stock	$	0.001	277,100	$	606,000	60,600	60,600
Series B Convertible Preferred Stock	$	0.001	8,860	None		—	—
Series C Convertible Preferred Stock	$	0.001	200,000	None		—	—
Series D Convertible Preferred Stock	$	0.0001	154,670	None		—	—
Series E Convertible Preferred Stock	$	0.001	865,824	None		655,044	655,044

Remaining Contractual

Executive ~~and Consulting~~ Agreements

~~The Company has longer-term contractual commitments with various consultants and employees.~~ Certain ~~employment~~executive agreements provide for severance ~~payments.~~payments in case of terminations without cause or certain change of control scenarios.

~~Lease Agreements~~

Research and Development and Clinical Trial Agreements

In March 2017, the Company entered into a license agreement with Nerviano which granted the Company development and commercialization rights to NMS-1286937, which ~~Trovagene~~Cardiff Oncology refers to as ~~PCM-075. PCM-075~~onvansertib. Onvansertib, an investigational drug, is an oral, ~~investigative drug~~ and a highly-selective adenosine triphosphate competitive inhibitor of the serine/threonine PLK 1. The Company plans to develop PCM-075 initially in patients with AML. Upon execution of the agreement, the Company paid $2.0 million in license fees which were expensed to research and development costs during the nine months ended September 30, 2017.PLK1. The Company is developing onvansertib in cancer indications with the greatest medical need for new treatment options. The Company was committed to ~~pay~~order $1.0 million ~~for~~of future services provided by Nerviano, such as the ~~costs~~cost to manufacture drug product, no later than June 30, ~~2019.~~2019, and these services have been purchased. Terms of the agreement also provide for the Company to pay development milestones and royalties based on ~~certain development and~~ sales ~~milestones.~~volume.

The Company has entered into a variety of clinical trial and collaboration agreements relating to its drug development efforts. Included in research and development expense, the Company has recorded approximately $291,000 for the nine months ended September 30, 2017 relating to services provided in connection with these agreements.

The Company is a party toof various agreements under which it licenses technology on an exclusive basis in the field of ~~human diagnostics.~~oncology therapeutics. These agreements include License fees, Royalties and Milestone payments. The company also has a legacy license agreement in the field of oncology diagnostics under which royalty payments are ~~generally~~due. These royalty payments are calculated as a ~~percentage~~percent of ~~product revenues, with rates that vary by agreement. To date,~~revenue. For the three and nine months ended September 30, 2021 and 2020, payments have not been material.

~~Trovagene~~Cardiff Oncology does not believe that ~~the Company~~it has legal liabilities that are probable or reasonably possible that require either accrual or disclosure, except for the following: On March 28, 2016 the Company filed a complaint in the Superior Court of the State of California for the County of San Diego against the Company’s former CEO and CFO, for, among other things, breach of fiduciary duty for failing to present a lucrative corporate opportunity to the Company concerning promising new therapeutics in the field of precision medicine and instead taking that opportunity for their own personal benefit (the “Complaint”). The Complaint asks that these two former executives be required to turn over their interests in these new therapeutics to the Company. The former CEO and CFO filed a cross complaint in the Superior Court of the State of California

~~Public Offering and Controlled Equity Offering~~

~~On March 15, 2017,~~

Gary Pace Securities Purchase Agreement

In May 2020, the Company ~~filed~~entered into a ~~Form 424B5 to amend and supplement~~Securities Purchase Agreement with Gary W. Pace, one of the ~~information in the Company’s registration statement and prospectus, dated June 13, 2016, to offer and sell additional~~Company's directors. Dr. Pace purchased 447,761 shares of the ~~Company’s~~Company's common stock ~~having~~at $1.34 per share for an aggregate ~~offering~~purchase price ~~up to $20,698,357. The~~of $600,000.

Leucadia Life Sciences

In November 2018, the Company entered into ana Material Transfer Agreement (“MTA”) with Leucadia Life Sciences (“Leucadia”) pursuant to which Leucadia developed a PCR-based assay for onvansertib for Acute Myeloid Leukemia (“AML”). This assay was completed in December 2020. During the duration of the agreement, ~~with Cantor Fitzgerald & Co. (“Agent”) on January 25, 2013 to issue and sell up to $30,000,000~~one of ~~shares~~the Company's directors Dr. Thomas Adams (who is no longer a director as of ~~common stock through the Agent. As payment for its services, the Agent is entitled to~~June 2021), was a ~~commission on gross proceeds~~principal stockholder of ~~up to 3%. Gross proceeds of approximately $110,000 have been raised in 2017.~~

~~On March 15, 2017, in~~Leucadia. In connection with the ~~addition of precision medicine therapeutics to its business,~~MTA, the Company ~~announced~~entered into a ~~restructuring plan (the “Restructuring”) which included a reduction in force. The Restructuring~~consulting agreement with Tommy Adams, Co-Founder & Chief Operating Officer of Leucadia, who is ~~expected to be completed in~~ the ~~last quarter~~son of ~~2017. The~~Dr. Adams. During the three months ended September 30, 2021 and 2020 the Company ~~estimates that it will incur~~incurred and recorded research and development expenses of approximately ~~$2.0~~$0 and $0.3 million, ~~in charges related to this Restructuring.~~respectively, for services performed by Leucadia and Tommy Adams. During the nine months ended September 30, ~~2017,~~2021 and 2020 the Company incurred and recorded research and development expenses of approximately ~~$1.7~~$0 and $0.8 million, in restructuring charges which included approximately $1.2 million of personnel termination costs and an approximately $0.5 million charge related to impairment of capitalized license fees. As of September 30, 2017, approximately $0.4 million of these restructuring costs were included in accrued liabilities in the condensed consolidated balance sheet.

In March 2016, the Company engaged Rutan & Tucker, LLP, a law firm to represent Trovagene, Inc. with respect to various lawsuits. One of the partners from Rutan & Tucker, LLP, is the son of the Company’s Chairman of the Board. The fees for legal services are based on the hourly rates of the individuals performing the legal services. During the nine months ended September 30, 2017 and 2016, the Company has incurred approximately $763,075 and $377,464 of legal expenses, net of insurance reimbursements,respectively, for services performed by ~~Rutan & Tucker, LLP, respectively.~~Leucadia and Tommy Adams.

~~12. Subsequent Event~~

~~On October 25, 2017,~~

The COVID-19 outbreak in the United States has caused significant business disruption. Thus far COVID-19 has not caused material disruptions to the Company's operational and financial performance. A prolonged outbreak could have a material adverse impact on financial results and business operations of the Company, ~~filed a registration statement on Form S-1 with~~including the ~~SEC for a best~~timing and ability of the Company to complete certain clinical trials and other efforts ~~public offering~~required to advance the development of ~~up to $17.5 million~~its drugs and raise additional capital.

Table of ~~common stock and warrants. H.C. Wainwright & Co. is acting as placement agent.~~Contents

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Forward-Looking Statements

This Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding the future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions.

In addition, our business and financial performance may be affected by the factors that are discussed under “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, ~~2016,~~2020, filed on ~~March 15, 2017, on Form 10-Q~~

~~for the period ended March 31, 2017, filed on May 10, 2017, and on Form 10-Q for the period ended June 30, 2017, filed on August 9, 2017.~~February 25, 2021. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for us to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

You should not rely upon ~~forward looking~~forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the ~~forward looking~~forward-looking statements will be achieved or occur. Although we believe that the expectations reflected in the ~~forward looking~~forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

The following discussion and analysis is qualified in its entirety by, and should be read in conjunction with, the more detailed information set forth in the financial statements and the notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q. This discussion should not be construed to imply that the results discussed herein will necessarily continue into the future, or that any conclusion reached herein will necessarily be indicative of actual operating results in the future. Such discussion represents only the best present assessment of our management.

Overview

We are a clinical-stage oncology company, developing new precision medicine ~~biotechnology company~~treatment options for cancer patients in indications with the greatest unmet medical need. Our goal is to target tumor vulnerabilities with treatment combinations that overcome disease resistance and improve disease response to standard treatment regimens and to increase overall survival. We are developing ~~oncology therapeutics~~onvansertib, an oral highly-selective Polo-like Kinase 1 ("PLK1") inhibitor, in combination with standard-of-care anti-cancer therapeutics. Our clinical development programs incorporate tumor genomics and biomarker technology to refine assessment of patient response to treatment.

We licensed onvansertib from Nerviano Medical Sciences ("NMS") pursuant to a license agreement with NMS dated March 13, 2017. This exclusive, world-wide license agreement includes 3 issued patents for ~~improved~~onvansertib which cover composition of matter, salt forms of onvansertib and combination of onvansertib with other drugs.

Onvansertib is a novel PLK1 selective adenosine triphosphate ("ATP") competitive inhibitor with oral bioavailability, and a relatively short drug half-life of 24 hours. Onvansertib is highly potent against the PLK1 enzyme (concentration for 50% inhibition [IC50]=5±3 nM), whereas low or no activity was observed on a panel of 63 kinases (IC50>500 nM), including the PLK members PLK2 and PLK3 (IC50>10 μM).

PLK1, a serine/threonine kinase, is a master regulator of mitotic progression with various roles and localizations during the different mitotic phases. Upon PLK1 depletion in cancer ~~care, optimizing drug development~~cells by ~~leveraging our proprietary PCM technology~~RNA interference ("RNAi"), inhibition of proliferation, and decreased viability, resulting from cell cycle arrest with 4N DNA content followed by apoptosis, are observed. PLK1 depletion also results in an increase in the number of cells containing abnormal spindle formation and misaligned chromosomes. Expression of PLK1 is seen in all proliferating normal tissues, and PLK1 is overexpressed in a number of tumors (including colorectal, pancreatic, prostate, ovary, breast and lung cancer), as well as in hematologic cancers.

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Although 5 different PLK family members are described in humans, the inhibition of the enzymatic activity or the depletion of PLK1 is sufficient to induce a G2/M cell cycle block and apoptosis in tumor ~~genomics. Our broad intellectual property~~cell lines and ~~proprietary technology enables us~~tumor regression in xenograft models. In addition, a tumor suppressor function has been described for PLK2 and PLK3 (but not PLK1), and they are reported to ~~measure ctDNA~~be expressed in ~~urine~~non-proliferating, differentiated postmitotic cells, such as neurons, indicating a potentially better safety profile for a PLK1-selective compound.

Onvansertib is a highly selective inhibitor of PLK1. The fumarate salt of the compound was formulated for oral administration and ~~blood~~is in clinical development for the treatment of a wide range of tumor types. There are 3 ongoing clinical studies of onvansertib in combination treatment: second line treatment in patients with KRAS-mutated metastatic colorectal cancer ("mCRC"), second line treatment in patients with metastatic pancreatic ductal adenocarcinoma ("mPDAC"), and in patients with metastatic castration-resistant prostate cancer ("mCRPC") showing resistance to ~~identify~~abiraterone.

In vitro studies have shown synergistic effects when onvansertib was administered in combination with different cytotoxic agents including antimicrotubule agents, topoisomerase 1 inhibitors, antimetabolites, alkylating agents, proteasome inhibitors, kinase inhibitors, BCL-2 inhibitors, and ~~quantify clinically actionable markers for predicting response to cancer therapies. We offer our PCM technology at our CLIA-certified/CAP-accredited laboratory~~androgen biosynthesis inhibitors.

In addition, in vivo combination studies have confirmed the positive results obtained in vitro and ~~plan to continue to vertically integrate our PCM technology~~synergistic effects have been observed in xenograft models of onvansertib in combination with ~~the development of precision cancer therapeutics.~~abiraterone, 5-fluorouracil (5 FU), irinotecan (including NKTR-102), quizartinib, venetoclax, and paclitaxel, while additive effects in combination with cytarabine or bevacizumab have been demonstrated.

We believe ~~we have an opportunity~~the high-selectivity of onvansertib to ~~utilize precision diagnostics~~PLK1, its 24-hour half-life, oral bioavailability, and flexible dosing schedule, as well as evidence of favorable safety and clinical benefit, with expected on-target, easy to ~~improve treatment outcomes for cancer patients using our proprietary technology to detect clinically actionable mutations~~manage and ~~monitor patient response to therapy. On March 15, 2017, we announced the licensing~~reversible side effects, may prove beneficial in addressing clinical therapeutic needs across a variety of PCM-075, a PLK1 inhibitor, from Nerviano. We have a supplier agreement with NerPharMa, S.r.l., a pharmaceutical manufacturing company and a subsidiary of Nerviano, to manufacture drug product for PCM-075. The agreement covers the clinical and commercial supply of PCM-075, and includes both Active Pharmaceutical Ingredients and Good Manufacturing Process production of capsules. The licensing of global development and commercialization rights to PCM-075 allows us to execute our strategy to vertically integrate our PCM technology with precision cancer therapeutics, by developing drugs where our deep understanding of tumor genomics may allow for effective targeting of appropriate cancer patients.cancers.

~~We have completed~~Ongoing Clinical Programs Update:

•TROV-054 is a Phase ~~1 safety study~~1b/2 open-label multi- center clinical trial of ~~PCM-075~~onvansertib in combination with FOLFIRI and bevacizumab ("Avastin®")for the second line treatment of patients with KRAS-mutated mCRC, which is being conducted at 7 clinical trial sites across the U.S. - USC Norris Comprehensive Cancer Center, The Mayo Clinic Cancer Centers (Arizona, Minnesota and Florida), Kansas University Medical Center, Inova Schar Cancer Institute and CARTI Cancer Center;

•CRDF-001 is a Phase 2 open-label multi-center clinical trial of onvansertib in combination with nanoliposomal irinotecan (“Onivyde®”), leucovorin, and fluorouracil for second line treatment of patients with mPDAC, which is being conducted at 6 clinical trial sites across the U.S. – The Mayo Clinic Cancer Centers (Arizona, Minnesota and Florida), Kansas University Medical Center, University of Nebraska Medical Center and Inova Schar Cancer Institute;

•TROV-053 is a Phase 2 open-label multi-center clinical trial of onvansertib in combination with abiraterone acetate (Zytiga®) and prednisone in patients with ~~advanced metastatic solid tumors~~mCRPC, which is being conducted at 3 clinical trial sites - Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute, and ~~we received notification from the U.S. Food and Drug Administration (“FDA”) that our~~Massachusetts General Hospital.

KRAS-mutated mCRC

TROV-054 is a Phase 1b/2 clinical trial of ~~PCM-075 in~~onvansertib for the second-line treatment of patients with ~~AML may proceed. PCM-075 has positive preclinical data as~~KRAS-mutated metastatic colorectal cancer ("mCRC") in combination with standard-of-care FOLFIRI and bevacizumab (Avastin®).

The primary objective of this trial is to evaluate the dose-limiting toxicities ("DLTs") and maximum tolerated dose ("MTD") or recommended Phase 2 dose ("RP2D") of onvansertib in combination with FOLFIRI and bevacizumab (Phase 1b) and to continue to assess the safety and preliminary efficacy of onvansertib in combination with FOLFIRI and bevacizumab (Phase 2).

The rationale for this clinical trial is based on three key principles including synthetic lethality, synergy and proof-of-concept clinical benefit. Synthetic lethality arises when a ~~single agent~~combination of deficiencies in the expression of two genes leads to cell death, whereas a deficiency in only one of these genes does not. The deficiencies can arise through mutations, epigenetic alterations or inhibitors of the protein encoded by one of the genes. In reference to onvansertib, CRC tumor cells harboring KRAS mutations are more vulnerable to cell death with PLK1 inhibition versus KRAS wild-type isogenic cells. Synergy occurs when the combination of two drugs results in an unexpected greater activity than an expected additive effect of the two drugs. Onvansertib in combination with irinotecan and in combination with ~~select chemotherapeutics~~5-FU (components of FOLFIRI) demonstrate synergy in colorectal cancer cell lines and ~~targeted agents~~both combinations have demonstrated significantly greater tumor growth inhibition than either

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drug alone.Proof-of-concept clinical response has been demonstrated in a previously completed Phase 1 trial in solid tumors in which 3 of 5 patients showing stable disease had tumors with a KRAS mutation; 2 in colorectal cancer and 1 in pancreatic cancer.

Data presented on September 8, 2021, at a key opinion leader webinar, provided an update of the ongoing phase 1b/2 clinical trial in KRAS-mutated metastatic colorectal cancer.

•8 of 19 (42%) patients treated per protocol at the recommended Phase 2 dose ("RP2D") of onvansertib 15 mg/m2 who were evaluable for disease response as of the data cut-off achieved a partial response ("PR"). Historically, objective response rates ("ORR") of 5-13% have been reported in a similar patient population treated with standard of care chemotherapy;

•12 of 32 (38%) patients evaluable for response as of data cutoff date across all dose levels achieved a PR;

•Median progression-free survival ("mPFS") across all response-evaluable patients is 9.4 months and has not yet been reached in those treated per protocol at the RP2D. Historically, mPFS of ~4.5-5.7 months has been reported in a similar patient population treated with standard of care chemotherapy;

•The combination regimen of onvansertib plus FOLFIRI/bevacizumab is well tolerated.

mPDAC

CRDF-001 is a Phase 2 clinical trial of onvansertib in combination with nanoliposomal irinotecan and 5-FU for the second line treatment of patients with metastatic pancreatic ductal adenocarcinoma ("mPDAC"). The first patient was dosed in June 2021.

The objective of this trial is to assess the safety and preliminary efficacy of onvansertib in combination with nanoliposomal irinotecan (Onyvide®), 5-FU and leucovorin as a second-line treatment in patients with mPDAC who have failed first-line gemcitabine-based therapy. The trial is expected to enroll approximately 45 patients across six sites in the U.S. including the three Mayo Clinic Cancer Centers (Arizona, Minnesota and Florida), Kansas University Medical Center, University of Nebraska Medical Center and Inova Schar Cancer Institute.

mCRPC

TROV-053 is a Phase 2 clinical trial of onvansertib in combination with Zytiga® (abiraterone) and prednisone for the treatment of patients with metastatic castration resistant prostate cancer ("mCRPC").

The primary objective of this trial is to observe the effects of onvansertib in combination with abiraterone and prednisone on disease control as assessed by prostate specific antigen ("PSA") decline or stabilization after 12 weeks of treatment in patients with mCRPC showing early signs of resistance to abiraterone.

The rationale for this trial is based on the mechanism of action ("MOA") of onvansertib and Zytiga® and the synergy of these two drugs when used in ~~many hematologic~~combination in pre-clinical experiments. Onvansertib inhibits tumor cell division (mitosis) by inducing G2/M arrest of tumor cells and ~~solid cancers, including AML, Non-Hodgkin Lymphoma, mCRPC, Adrenocortical Carcinoma,~~the combination of onvansertib and ~~Triple Negative Breast Cancer.~~Zytiga® significantly increases mitotic arrest and is synergistic when used in combination. Additionally, PLK1 inhibition appears to enhance the efficacy of androgen signaling blockade in castration-resistant prostate cancer.

~~We have significant experience and expertise with biomarkers and technology in cancer, including AML. We are one~~Data as of July 2, 2021, as follow-up to the data presented on February 11, 2021, at the American Society of Clinical Oncology Genitourinary Cancers Symposium (“ASCO-GU”) provided evidence of the ~~patent holders~~safety and efficacy of ~~NPM1 for diagnosis~~onvansertib in combination with abiraterone. Arms A (n=17) and ~~monitoring~~B (n=20) and C (13) showed 29%, 40% and 54% of ~~patients. NPM1-mutated AML is a genetic marker~~patients, respectively, achieving the primary endpoint of disease control at 12 weeks. The more continuous dosing schedule of Arm C has shown an increase in ~~leukemia~~the rate of patients achieving disease stabilization, to-date. Evidence of efficacy was observed in patients harboring AR alterations across all 3 arms. ctDNA analysis revealed differences in baseline genomic profiles of patients achieving SD at 12 weeks vs. patients progressing before or at 12 weeks. Mutations exclusively present in patients with SD were associated with cell cycle and ~~accounts for approximately one-third~~DNA repair pathways that may result in increased sensitivity to onvansertib and efficacy of the combination. Onvansertib plus abiraterone has demonstrated safety across all ~~AML patients.~~3 dosing schedules.

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Company Updates

Company

On July 12, 2021, we announced the appointments of Katherine L. Ruffner, M.D., as Chief Medical Officer and James E. Levine as Chief Financial Officer. We ~~plan to use our PCM technology to profile other dominant AML markers, such as FLT3, DNMT3A, NRAS,~~entered into an employment agreement with Mr. Levine on July 12, 2021 and ~~KIT, as well as to measure PLK1 enzymatic activity to potentially identify patients most likely to respond to PCM-075 and to measure patient therapy response.~~with Dr. Ruffner on August 4, 2021.

Our accumulated deficit through September 30, ~~2017~~2021 is ~~$170,470,696.~~$250.4 million. To date, we have generated minimal revenues and expect to incur additional losses to perform further research and development ~~activities and expand commercial operations. During 2017, we have advanced our business with the following activities:~~activities.

~~Announced preclinical research demonstrating synergy of PCM-075 with Zytiga® (abiraterone acetate) in Castration-Resistant Prostate Cancer tumor cells.~~

~~Announced that the FDA granted Orphan Drug Designation to PCM-075 for the treatment of patients with AML.~~

Announced the expansion and strengthening of its Board of Directors with the appointment of Athena Countouriotis, M.D. Dr. Countouriotis brings significant experience in oncology clinical development and orphan indications

Announced PCM-075 synergy with a HDAC Inhibitor in Non-Hodgkin Lymphoma Cell Lines. Additionally, PCM-075 demonstrates synergy in combination with more than ten chemotherapeutic and targeted therapies across a broad range of solid tumor and hematologic cancers.

~~Announced preclinical AML data shows PCM-075 significantly enhances the efficacy of a FLT3 inhibitor in combination therapy.~~

~~Announced FDA approval of IND for Phase 1b/2 trial of PCM-075 in patients with AML.~~

Announced peer-reviewed publication of first-in-human Phase 1 trial results with PCM-075 in the journal Investigational New Drugs. The data from the trial demonstrated PCM-075’s potential as safe and effective treatment for solid tumor and hematological malignancies.

Completed a registered direct offering of 6,191,500 shares of common stock and a concurrent private placement issuing warrants to purchase up to 4,643,626 shares of common stock. The net proceeds from the registered direct offering and concurrent private placement were approximately $6.5 million in July 2017.

Entered into an agreement with Novogene Co. Ltd. (“Novogene”), a leading global provider of genomic services and solutions and the largest sequencing capacity in the world, whereby Novogene will purchase NextCollect™, our proprietary urine collection and nucleic acid preservation device for validation in the Chinese market.

~~Engaged PRA Health Sciences, a leading, global contract research organization, to conduct our Phase 1b/2 clinical trial of PCM-075.~~

~~Executed a supplier agreement with NerPharMa, S.r.l., a pharmaceutical manufacturing company and a subsidiary of Nerviano Medical Sciences S.r.l., to manufacture drug product for PCM-075.~~

~~Submitted an IND application to FDA to conduct a Phase 1b/2 clinical trial of PCM-075 in AML.~~

~~Announced expansion of key claims for our NPM1 patent portfolio for AML.~~

~~Entered into an agreement with a global biopharmaceutical company to utilize Trovera® ctDNA tests and services in cancer clinical trials.~~

~~Entered into an agreement with AstraZeneca to utilize Trovera® ctDNA test and services in prospective biomarker study.~~

~~Announced phase 1 safety study conducted by Nerviano Medical Sciences supports planned development of PCM-075 in AML.~~

Established a Clinical Advisory Board, appointing Dr. Jorge Cortes, of MD Anderson, Dr. Sandra Silberman, a leading clinical researcher in hematology/oncology, and practicing physician at the Duke VAMC, Dr. Filip Janku, of City of Hope Cancer Center, and Dr. David Berz, of the Beverly Hills Cancer Center. Dr. Cortes and Dr. Silberman have extensive experience in the development of novel therapies for the treatment of hematologic cancers. Dr. Cortes will serve as the Principal Investigator for the Phase 1b/2 clinical trial in AML.

Entered into a license agreement with Nerviano that grants us exclusive global development and commercialization rights to NMS-1286937, which we refers to as PCM-075. PCM-075 is an oral, investigative drug and a highly-selective PLK 1 inhibitor for the treatment of AML.

Our drug development efforts are in their early stages, and we cannot make estimates of the costs or the time that our development efforts will take to complete, or the timing and amount of revenues related to the sale of our drugs. The risk of completion of any program is high because of the many uncertainties involved in developing new drug candidates to market, including the long duration of clinical testing, the specific performance of proposed products under stringent clinical trial protocols, extended regulatory approval and review cycles, our ability to raise additional capital, the nature and timing of

research and development expenses, and competing technologies being developed by organizations with significantly greater resources.

Off-Balance Sheet Arrangements

We had no off-balance sheet arrangements as of September 30, ~~2017.~~2021.

Critical Accounting Policies

~~Financial Reporting Release No. 60 requires all companies to include a discussion of critical accounting policies or methods used in the preparation of financial statements.~~ Our accounting policies are described in ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS of our Annual Report on Form 10-K as of and for the year ended December 31, ~~2016,~~2020, filed with the SEC on ~~March 15, 2017.~~February 25, 2021. There have been no changes to our critical accounting policies since December 31, ~~2016.~~2020.

RESULTS OF OPERATIONS

Three Months Ended September 30, ~~2017~~2021 and ~~2016~~2020

Revenues

~~Our total~~Total revenues were ~~$123,329 and $89,114~~$86,000 for the three months ended September 30, ~~2017 and 2016, respectively. The components of our revenues were as follows:~~

Three Months Ended September 30,
2017 2016 Increase (Decrease)
Royalties $ 58,779
$ 47,236
$ 11,543
Diagnostic services 58,119
37,978
20,141
Clinical research services 6,431
3,900
2,531
Total revenues $ 123,329
$ 89,114
$ 34,215

The increase in royalty income related primarily to higher receipts of payments in excess of minimum royalties in comparison to the same period of the prior year. Revenue from diagnostic services is recognized when payment is received for the test results. The number of payments received was higher in 20172021 as compared to ~~the same period in~~$136,000 for the prior ~~year.~~period. Revenues are from our sales-based or usage-based royalties on other intellectual property licenses, unrelated to onvansertib. Revenue ~~from clinical research services consists~~recognition of ~~revenue from~~ the sale of urine and blood collection supplies and tests performed under agreements with our clinical research and business development partners. Revenue is recognized when supplies and/or test results are delivered. There were more sales of clinical research services for the three months ended September 30, 2017 as compared to the same period of 2016.

~~We expect our royalties to fluctuate as the royalties are based~~royalty depends on the ~~minimum royalty payments as well as~~timing and overall sales activities of the timing of when payments are received for royalties in excess of minimum royalties. In addition, our diagnostic service revenue may be impacted by our expansion into oncology therapeutics. We expect revenue from clinical research services to fluctuate based on timing of delivery of supplies and/or test results under agreements.licensees.

~~Cost of Revenues~~

Our total cost of revenues was $473,202 for the three months ended September 30, 2017, compared to $424,559 in the same period of 2016. Cost of revenues mainly relates to the costs of our diagnostic service revenues. The costs are recognized at the completion of testing. Increase in cost of revenues for the three months ended September 30, 2017 compared to the same period of last year is mainly due to the higher percentage allocation of volume of tests processed. Due to revenue being recognized when cash is received, costs incurred in one period may relate to revenue recognized in a later period which could result in negative gross margins.

Research and Development Expenses

Research and development expenses consisted of the following:

Three Months Ended September 30,
2017 2016 Increase (Decrease)
Salaries and staff costs $ 301,919
$ 1,407,529
$ (1,105,610 )
Stock-based compensation 219,480
872,792
(653,312 )
Outside services, consultants and lab supplies 604,140
1,215,889
(611,749 )
Facilities 254,681
372,891
(118,210 )
Travel and scientific conferences 28,000
51,203
(23,203 )
Other 6,486
17,094
(10,608 )
Total research and development $ 1,414,706
$ 3,937,398
$ (2,522,692 )


	Three Months Ended September 30,
(in thousands)	2021		2020		Increase (Decrease)
Salaries and staff costs	$	521	$	412	$	109
Stock-based compensation	174		104		70
Clinical trials, outside services, and lab supplies	3,104		2,151		953


Facilities and other	355		188		167
Total research and development	$	4,154	$	2,855	$	1,299

Research and development expenses ~~decreased~~increased by ~~$2,522,692 to $1,414,706~~$1.3 million for the three months ended September 30, ~~2017 from $3,937,398 for~~2021 compared to the same period in ~~2016. As a result of the two strategic restructuring activities which occurred~~2020. The overall increase in ~~December 2016 and March 2017, our average internal~~ research and development personnel decreased from thirty-four to six, resulting in a decrease of expenses in salaries and staff costs, stock-based compensation, and travel and scientific conferences. In addition, due to the shifting of our business focus, we terminated certain clinical studies and collaboration agreements. Research and development expenses incurred related to samples processed and validated in connection with the clinical collaborations, as well as lab supplies, decreased accordingly. We expect a reduction of research and development costs that relate to CLIA services as a result of our expansion into oncology therapeutics; however, other costs may increase as we complete the development of PCM-075.

~~Selling and Marketing Expenses~~

~~Selling and marketing expenses consisted of the following:~~

Three Months Ended September 30,
2017 2016 Increase (Decrease)
Salaries and staff costs $ 158,097
$ 1,427,254
$ (1,269,157 )
Stock-based compensation 118,434
476,865
(358,431 )
Outside services and consultants 51,717
441,699
(389,982 )
Facilities 51,388
112,573
(61,185 )
Trade shows, conferences and marketing 31,017
243,692
(212,675 )
Travel 54
212,375
(212,321 )
Other 9,220
26,404
(17,184 )
Total sales and marketing $ 419,927

$ 2,940,862

$ (2,520,935 )

Selling and marketing expenses decreased by $2,520,935 to $419,927 for the three months ended September 30, 2017 from $2,940,862 for the same period in 2016. The overall decrease in selling and marketing expenses was primarily due to our strategic restructuring activities. During the three months ended September 30, 2017 we decreased the number of our field sales, customer support and marketing personnel, bringing our average headcount to two from twenty-two in the same period of the prior year. As a result, costs associated with ~~selling~~clinical programs and ~~marketing activities as well as personnel~~outside service costs for three ongoing clinical trials related to the development of our lead drug candidate, onvansertib. Facilities costs ~~were decreased accordingly. We expect decreases~~increased due to amending our operating lease. Salaries and staff costs increased primarily due to increased headcount in ~~personnel and related costs as a result~~the current period.

Table of ~~the reduction in force.~~Contents

Selling, General and Administrative Expenses

~~General~~Selling, general and administrative expenses consisted of the following:

Three Months Ended September 30,
2017 2016 Increase (Decrease)
Personnel and outside services costs $ 1,450,261
$ 1,136,266
$ 313,995
Board of Directors’ fees 120,085
122,187
(2,102 )
Stock-based compensation 1,067,633
437,075
630,558
Legal and accounting fees 595,194
695,061
(99,867 )
Facilities and insurance 291,547
149,921
141,626
Travel 14,185
47,769
(33,584 )
Fees, licenses, taxes and other 120,682
122,503
(1,821 )
Total general and administrative $ 3,659,587

$ 2,710,782
$ 948,805


	Three Months Ended September 30,
(in thousands)	2021		2020		Increase (Decrease)
Salaries and staff costs	$	671	$	520	$	151

Stock-based compensation	766		258		508
Outside services and professional fees	914		488		426



Facilities and other	579		378		201
Total selling, general and administrative	$	2,930	$	1,644	$	1,286

~~General~~Selling, general and administrative expenses increased by ~~$948,805 to $3,659,587~~$1.3 million for the three months ended September 30, ~~2017, from $2,710,782 for~~2021 compared to the same period in ~~2016.~~2020. The significant components of the increase were ~~primarily due to the increase in personnel and~~ outside services ~~cost~~ and stock-based compensation. In August 2017, a total of 745,392 shares of immediately vested RSA were granted to our CEO. Per the agreement, the CEO’s income taxes associated with the RSA were also paid by our Company. Therefore, personnel costs andThe increase in stock-based compensation expenses were increased. Our general and administrative costs may increase in future periods in order to support fundraising activities and general business activities as we continue to develop and introduce new product offerings.

~~Restructuring~~

On March 15, 2017, we announced a strategic restructuring plan in connection with the expansion of precision medicine therapeutics to our business. The restructuring plan includes a reduction in force and is expected to be completed in the last quarter of 2017. The $46,472 restructuring benefit for the three months ended September 30, 2017 was primarily due to certain employee termination costs expensed was less than estimated.

~~Net Interest Expense~~

~~Net interest expense was $16,473 and $354,993 for the three months ended September 30, 2017 and 2016, respectively. The decrease of net interest expense~~ is primarily due to ~~a decrease~~new stock option grants issued to employees and directors. The increase in ~~interest expense, resulting from pay-off~~outside services and professional fees is primarily due to increased investor relations fees, recruiting fees, and legal fees related to the expansion of our ~~$15.0 million term loan. We expect net interest expense to decrease as a result of repayment of our equipment line of credit.~~patent portfolio.

Change in Fair Value of Derivative Financial Instruments — Warrants

We have issued warrants that are accounted for as derivative liabilities. As of September 30, ~~2017,~~2021, the derivative financial instruments—warrants liabilities were revalued to ~~$2,037,712,~~$5,000, resulting in an increase in value of ~~$1,686,850~~$12,000 from June 30, ~~2017,~~2021, based primarily upon the ~~issuance of new derivative financial instruments—warrants in connection with July fundraising activities, offset by the decrease~~fluctuation in our stock price as well as the ~~changes~~decrease in the ~~expected term, volatility, and risk free interest rates for~~remaining life of the ~~expected term. The issuance of new warrants was recorded as a liability under derivative financial instruments~~—~~warrants in the condensed consolidated balance sheets.~~warrants. The decrease in value upon remeasurement at September 30, ~~2017~~2021 was recorded as a gain from the change in fair value of derivative financial instruments—warrants in the condensed ~~consolidated~~ statement of operations.

Net Loss

Net loss and per share amounts were as follows:

Three Months Ended September 30,
2017 2016 Increase (Decrease)
Net loss attributable to common shareholders $ (4,298,026 ) $ (10,197,332 ) $ (5,899,306 )
Net loss per common share — basic $ (0.12 ) $ (0.34 ) $ (0.22 )
Net loss per common share — diluted $ (0.12 ) $ (0.34 ) $ (0.22 )

Weighted average shares outstanding — basic 36,465,672
30,339,774
6,125,898
Weighted average shares outstanding — diluted 36,465,672
30,339,774
6,125,898


	Three Months Ended September 30,
(in thousands, except per share amounts)	2021		2020		Increase (Decrease)
Net loss	$	(6,913)	$	(4,497)	$	2,416
Preferred stock dividend	(6)		(6)		—
Net loss attributable to common shareholders	$	(6,919)	$	(4,503)	$	2,416

Net loss per common share — basic and diluted	$	(0.17)	$	(0.19)	$	(0.02)


Weighted average shares outstanding — basic and diluted	39,552		23,341		16,211

The ~~$5,899,306 decrease~~$2.4 million increase in net loss attributable to common shareholders ~~and the $0.22 decrease in basic net loss per share~~ was primarily the result of ~~a decrease in~~an increase of operating expenses ~~of $4,092,651~~ for the three months ended September 30, ~~2017 compared to the same period in the prior year.~~

~~Nine Months Ended September 30, 2017 and 2016~~

~~Revenues~~

~~Our total revenues were $320,378 and $313,000 for the nine months ended September 30, 2017 and 2016, respectively. The components of our revenues were as follows:~~

Nine Months Ended September 30,
2017 2016 Increase (Decrease)
Royalties $ 169,415
$ 207,869
$ (38,454 )
Diagnostic services 142,482
69,558
72,924
Clinical research services 8,481
35,573
(27,092 )
Total revenues $ 320,378
$ 313,000
$ 7,378

The $38,454 decrease in royalties related primarily to lower receipts of payments in excess of minimum royalties in comparison to the same period of the prior year. Revenue from diagnostic services is recognized when payment is received for the test results. The number of tests payments received were higher for the nine months ended September 30, 2017 as 2021, compared to the same period in the prior year. ~~Revenue from clinical research services consists of revenue~~The $0.02 decrease in net loss per share was impacted by the increase in basic weighted average shares outstanding resulting primarily from the ~~sale~~issuance of ~~urine~~approximately 13.3 million shares of common stock and ~~blood collection supplies~~common stock equivalents from October 1, 2020 through September 30, 2021.

Nine Months Ended September 30, 2021 and ~~tests performed under agreements with our clinical research and business development partners. Revenue was recognized when supplies and/or test results were delivered.~~2020

We expect our royalties to fluctuate as the royalties are based on the minimum royalty payments as well as the timing of when payments are received for royalties in excess of minimum royalties. Our diagnostic service revenue may be impacted by our expansion into oncology therapeutics. In addition, we expect revenue from clinical research services to fluctuate based on timing of delivery of supplies under agreements.

~~Cost of~~ Revenues

~~Our total cost of~~Total revenues ~~was $1,427,831~~were $226,000 for the nine months ended September 30, ~~2017,~~2021 as compared to ~~$1,143,293 in the same period of 2016. Cost of revenues relates to the costs of our diagnostic service revenues. The costs are recognized at the completion of testing. Increase in cost of revenues~~$247,000 for the ~~nine months ended September 30, 2017 compared~~prior period. Revenues are from our sales-based or usage-based royalties on other intellectual property licenses, unrelated to onvansertib. Revenue recognition of the ~~same period~~royalty depends on the timing and overall sales activities of ~~last year is mainly due to~~ the higher percentage allocation of volume of tests. Due to revenue being recognized when cash is received, costs incurred in one period may relate to revenue recognized in a later period which could result in negative gross margins. licensees.

Table of Contents

Research and Development Expenses

Research and development expenses consisted of the following:


	Nine Months Ended September 30,
(in thousands)	2021		2020		Increase (Decrease)
Salaries and staff costs	$	1,095	$	1,261	$	(166)
Stock-based compensation	286		251		35
Clinical trials, outside services, and lab supplies	9,510		5,933		3,577


Facilities and other	661		591		70
Total research and development	$	11,552	$	8,036	$	3,516

Nine Months Ended September 30,
2017 2016 Increase (Decrease)
Salaries and staff costs $ 1,468,491
$ 4,263,595
$ (2,795,104 )
Stock-based compensation 798,143
1,862,069
(1,063,926 )
Outside services, consultants and lab supplies 1,456,504
3,837,485
(2,380,981 )
Facilities 842,196
1,042,682
(200,486 )
Travel and scientific conferences 72,901
157,445
(84,544 )
Fees, licenses and other 2,038,016
58,600
1,979,416
Total research and development $ 6,676,251
$ 11,221,876
$ (4,545,625 )

Research and development expenses ~~decreased~~increased by ~~$4,545,625 to $6,676,251~~$3.5 million for the nine months ended September 30, ~~2017 from $11,221,876 for~~2021 compared to the same period in ~~2016. Our~~2020. The overall increase in research and development expenses was primarily due to costs ~~have~~associated with clinical programs and outside service costs for three ongoing clinical trials related to the development of our lead drug candidate, onvansertib. Salaries and staff costs decreased primarily due to departmental changes of certain executives in the ~~average number~~current period.

Selling, General and Administrative Expenses

Selling, general and administrative expenses consisted of ~~our internal research~~the following:


	Nine Months Ended September 30,
(in thousands)	2021		2020		Increase (Decrease)
Salaries and staff costs	$	1,752	$	1,565	$	187

Stock-based compensation	1,958		570		1,388
Outside services and professional fees	2,799		1,468		1,331



Facilities and other	1,494		1,197		297
Total selling, general and administrative	$	8,003	$	4,800	$	3,203

Selling, general and ~~development personnel decreasing from thirty-three to eleven. In addition, research and development~~administrative expenses ~~incurred related to clinical studies, samples processed and validated in connection with the clinical collaborations, as well as lab supplies, decreased~~increased by $3.2 million for the nine months ended September 30, ~~2017 as~~2021 compared to the same period in ~~2016 as a result~~2020. The significant components of the ~~shifting of our business focus. The total decrease of research~~increase were outside services and ~~development expenses was offset by the increase in fees, license and other.~~stock-based compensation. The increase in ~~fees, license and other was~~stock-based compensation is primarily due to additional stock option grants to employees and directors during the ~~$2.0 million license fee payment~~period and the modification of stock option grants for departing directors in ~~March 2017 to Nerviano for development~~June 2021. The increase in outside services and commercialization rights to PCM-075. We expect a reduction of research and development costs that relate to CLIA services as a result of our expansion into oncology therapeutics; however, other costs may increase as we continue the development of PCM-075.

~~Selling and Marketing Expenses~~

~~Selling and marketing expenses consisted of the following:~~

Nine Months Ended September 30,
2017 2016 Increase (Decrease)
Salaries and staff costs $ 977,040
$ 4,266,029
$ (3,288,989 )
Stock-based compensation 550,317
1,493,744
(943,427 )
Outside services and consultants 219,800
1,117,368
(897,568 )
Facilities 220,860
362,339
(141,479 )
Trade shows, conferences and marketing 357,233
1,082,883
(725,650 )
Travel 71,865
716,473
(644,608 )
Other 45,816
88,614
(42,798 )
Total sales and marketing $ 2,442,931
$ 9,127,450
$ (6,684,519 )

Selling and marketing expenses decreased by $6,684,519 to $2,442,931 for the nine months ended September 30, 2017 from $9,127,450 for the same period in 2016. The overall decrease in selling and marketing expenses wasprofessional fees is primarily due to ~~our strategic restructuring activities. As part~~increased legal fees related to the expansion of our ~~restructuring, we reduced the number~~patent portfolio. Outside services also increased from recruiting fees and board of our field sales, customer support and marketing personnel, bringing down our average headcount to five from twenty-two in the same period of the prior year. We expect decreases in personnel and related costs due to the reduction in force.

~~General and Administrative Expenses~~

~~General and administrative expenses consisted of the following:~~

Nine Months Ended September 30,
2017 2016 Increase (Decrease)
Personnel and outside services costs $ 3,270,134
$ 3,279,860
$ (9,726 )
Board of Directors’ fees 347,205
345,240
1,965
Stock-based compensation 1,837,128
2,487,415
(650,287 )
Legal and accounting fees 3,358,411
2,077,585
1,280,826
Facilities and insurance 742,405
551,382
191,023
Travel 81,106
151,355
(70,249 )
Fees, licenses, taxes and other 278,970
290,924
(11,954 )
Total general and administrative $ 9,915,359
$ 9,183,761
$ 731,598

General and administrative expenses increased by $731,598 to $9,915,359 for the nine months ended September 30, 2017, from $9,183,761 for the same period in 2016. The increase was primarily due to an increase in legal fees offset by the decrease of stock-based compensation. Legal fees increased primarily as a result of a litigation related loss contingency of $2.1 million expensed during the nine months ended September 30, 2017. Stock-based compensation, a non-cash expense, will fluctuate based on the timing and amount of options granted, forfeitures and the fair value of the options at the time of grant or remeasurement.

~~Restructuring~~

On March 15, 2017, we announced a strategic restructuring plan in connection with the addition of precision medicine therapeutics to our business. The restructuring plan includes a reduction in force and is expected to be completed in the last quarter of 2017. Restructuring charges of approximately $1.7 million were incurred and have been included as a component of operating loss for the nine months ended September 30, 2017. Of the total restructuring charges, approximately $1.2 million was related to termination of employees and an approximately $0.5 million charge related to impaired licensedirectors fees.

~~Net Interest Expense~~

Net interest expense was $877,741 and $967,522 for nine months ended September 30, 2017 and 2016, respectively. The decrease of net interest expense is due to a decrease in interest expense of approximately $184,000, resulting from pay-off of our $15.0 million term loan, offset by a decrease in interest income as a result of liquidation of our short-term investments.

Change in Fair Value of Derivative Financial Instruments — Warrants

We have issued warrants that are accounted for as derivative liabilities. As of September 30, ~~2017,~~2021, the derivative financial instruments—warrants liabilities were revalued to ~~$2,037,712,~~$5,000, resulting in ~~an increase~~a decrease in value of ~~$1,202,772~~$280,000 from December 31, ~~2016,~~2020, based primarily upon the ~~issuance of new derivative financial instruments—warrants in connection with July fundraising activities, offset by the decrease~~fluctuation in our stock price, as well as the ~~changes~~decrease in the ~~expected term, volatility, and risk free interest rates for~~remaining life of the ~~expected term.~~warrants. The ~~issuance of new warrants was recorded as a liability under derivative financial instruments~~—~~warrants~~change in ~~the condensed consolidated balance sheets. The decrease in~~ value upon remeasurement at September 30, 2021 was recorded as a gain from the change in fair value of derivative financial instruments—warrants in the condensed ~~consolidated~~ statement of operations.

Table of Contents

Net Loss

Net loss and per share amounts were as follows:

Nine Months Ended September 30,
2017 2016 Increase (Decrease)
Net loss attributable to common shareholders $ (22,355,494 ) $ (30,674,248 ) $ (8,318,754 )
Net loss per common share — basic $ (0.68 ) $ (1.02 ) $ (0.34 )
Net loss per common share — diluted $ (0.68 ) $ (1.04 ) $ (0.36 )

Weighted average shares outstanding — basic 32,826,306
30,018,841
2,807,465
Weighted average shares outstanding — diluted 32,826,306
30,136,572
2,689,734


	Nine Months Ended September 30,
(in thousands, except per share amounts)	2021		2020		Increase (Decrease)
Net loss	$	(18,849)	$	(12,710)	$	6,139
Preferred stock dividend	(18)		(3,285)		(3,267)
Net loss attributable to common shareholders	$	(18,867)	$	(15,995)	$	2,872

Net loss per common share — basic and diluted	$	(0.49)	$	(1.00)	$	(0.51)


Weighted average shares outstanding — basic and diluted	38,501		15,942		22,559

The ~~$8,318,754 decrease~~$2.9 million increase in net loss attributable to common shareholders ~~and the $0.34 decrease in basic net loss per share~~ was primarily the result of an increase in operating expenses, offset by a decrease in ~~operating expenses~~preferred stock dividend for the nine months ended September 30, 2021 compared to the same period in the prior year. ~~This~~The $0.51 decrease in basic net loss per share was ~~offset~~impacted by ~~a loss on extinguishment~~the increase in weighted average shares outstanding resulting primarily from the issuance of ~~debt~~approximately 13.3 million shares of ~~$1.7 million.~~common stock from October 1, 2020 through September 30, 2021.

LIQUIDITY AND CAPITAL RESOURCES

AsThe COVID-19 outbreak in the United States has caused business disruptions. Thus far COVID-19 has not caused material disruptions to our operational and financial performance. The extent of ~~September 30, 2017, we had $7,434,298 in cash~~the impact of COVID-19 on our future operational and ~~cash equivalents.~~ financial performance will depend on certain developments, including the duration and spread of the outbreak, and impact on our clinical trials, employees and vendors, all of which are uncertain and cannot be predicted. The economic effects of the outbreak could also have an adverse effect on our ability to raise additional capital.

Net cash used in operating activities for the nine months ended September 30, ~~2017~~2021 was ~~$19,949,652,~~$15.7 million, compared to ~~$22,034,998~~$11.2 million for the nine months ended September 30, ~~2016.~~2020. Our use of cash was primarily a result of the net loss of ~~$22,337,314~~$18.8 million for the nine months ended September 30, ~~2017,~~2021, adjusted for non-cash items related to stock-based compensation of ~~$3,117,364, loss on extinguishment~~$2.2 million, release of ~~debt~~clinical trial funding commitment of ~~$1,655,825, impairment loss of $485,000, depreciation and~~$1.5 million, amortization of ~~$956,995,~~premiums on short-term investments $1.2 million, and ~~the gain from the~~depreciation of $0.3 million. The net change ~~in fair value of derivative financial instruments~~—~~warrants of $2,012,747. The changes~~ in our operating assets and liabilities ~~consisted of lower accounts payable and accrued expenses, an increase~~was $1.8 million increasing cash used in ~~accounts receivable and a decreased prepaid expenses.~~operations. At our current and anticipated level of operating loss, we expect to continue to incur an operating cash outflow for the next several years.

Net cash ~~provided by~~used in investing activities was ~~$23,925,535~~$122.7 million primarily related to net purchases of marketable securities during the nine months ended September 30, ~~2017,~~2021, compared to ~~$25,249,392 used in~~$0.2 million investing activities for the same period in ~~2016. Investing~~2020.

Net cash provided in financing activities was $20.5 million during the nine months ended September 30, 2021, compared to $37.6 million for the same period in 2020. Net cash provided in financing activities during the nine months ended September 30, ~~2017 consisted~~2021 was $19.2 million from the sale of ~~net sales~~common stock and ~~maturities~~$1.3 million proceeds from the exercise of ~~short-term investments of $24,061,786 offset by net purchases for capital equipment of $136,251.~~

warrants. Net cash ~~used in financing activities was $10,447,842 during the nine months ended September 30, 2017, compared to $2,361,994~~ provided in financing ~~activities for the same period in 2016. Financing~~ activities during the nine months ended September 30, ~~2017 related primarily to~~2020 was from $19.0 million of proceeds from the ~~pay-off~~exercise of ~~long-term debt resulting in debt extinguishment offset by~~warrants and $18.3 million from the sale of common stock, ~~while financing activities during the same period of the prior year consisted primarily of sales of common~~preferred stock ~~offset by repayment of long-term debt. On June 1, 2017, we received a Notice of Event of Default from the lenders which stated that Events of Default had occurred~~ and all of the obligation under the Loan and Security Agreement dated as of June 30, 2014 were immediately due and payable. On June 6, 2017, the lenders took the total pay-off amount of $16,668,583 out of our bank accounts which satisfied all of our outstanding obligations under the Agreement. We disagree with the lenders that any Event of Default has occurred and are reserving all of our options with respect to the Agreement. warrants.

As of September 30, ~~2017,~~2021, and December 31, ~~2016,~~2020, we had working capital of ~~$3,469,622~~$132.7 million and ~~$31,152,936,~~$127.2 million, respectively.

~~On October 25, 2017,~~We have incurred net losses since our inception and have negative operating cash flows. As of September 30, 2021, we ~~filed a registration statement~~had $134.0 million in cash, cash equivalents and short-term investments and we believe we have sufficient cash to meet our funding requirements for at least the next 12 months following the issuance date of this Quarterly Report on Form ~~S-1 with~~10-Q.

For the ~~SEC for a best efforts public offering of up to $17.5 million of common stock and warrants. H.C. Wainwright & Co. is acting as placement agent.~~

~~Based on our current business plan and assumptions,~~foreseeable future, we expect to continue to incur ~~significant~~ losses and require ~~significant~~ additional capital to further advance our clinical trial programs and support our other operations. Considering our current cash resources, including the net proceeds received from the offering of our equity securities in July 2017, we believe our existing resources will be sufficient to fund the Company’s planned operations into the first quarter of 2018. In addition, we have based our cash sufficiency estimates on our current business plan and assumptions that may prove to be wrong. We could utilize our available capital resources sooner than we currently expect, and we could need additional funding to sustain

~~our operations even sooner than currently anticipated. These circumstances raise substantial doubt about our ability to continue as a going concern.~~

Our working capital requirements will depend upon numerous factors including but not limited to the nature, cost and timing of our research and development programs. To date, our sources of cash have been primarily limited to the sale of equity securities. We cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that we can raise additional funds by issuing equity securities, our stockholders may experience ~~significant~~additional dilution. ~~Any debt financing, if available, may involve restrictive covenants that impact~~The economic effects of COVID-19 could also have an adverse effect on our ability to ~~conduct business. If we are unable to~~ raise additional ~~capital when required or on acceptable terms, we may have to significantly delay, scale back or discontinue the development and/or commercialization~~capital.

Table of one or more product candidates, all of which may have a material adverse impact on our operations. We may also be required to (i) seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; or (ii) relinquish or otherwise dispose of rights to technologies, product candidates or products that we would otherwise seek to develop or commercialize ourselves on unfavorable terms. We are evaluating the following options to raise additional capital, increase revenue, as well as reduce costs, in an effort to strengthen our liquidity position: (1) Raising capital through public and private equity offerings; (2) Adding capital through short-term and long-term borrowings; (3) Introducing operation and business development initiatives to bring in new revenue streams by leveraging capabilities within our CLIA lab, as well as monetizing our proprietary NextCollect™ DNA collection and preservation cup; (4) Reducing operating costs by identifying internal synergies; (5) Engaging in strategic partnerships; and (6) Taking actions to reduce or delay capital expenditures. We continually assess any spending plans, including a review of our discretionary spending in connection with certain strategic contracts, to effectively and efficiently address our liquidity needs.Contents

~~NASDAQ Notice~~

On September 5, 2017, we received a written notice from the NASDAQ Stock Market LLC (“NASDAQ”) that we were not in compliance with NASDAQ Listing Rule 5550(a)(2) for continued listing on the NASDAQ Capital Market, as the minimum bid price of our common stock had been below $1.00 per share for 30 consecutive business days. The Notice had no immediate effect on the listing of our common stock, and our common stock continue to trade on the NASDAQ Capital Market under the symbol “TROV”.

In accordance with NASDAQ Listing Rule 5810(c)(3)(A), we have a period of 180 calendar days, or until March 5, 2018, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of our common stock must meet or exceed $1.00 per share for at least ten consecutive business days during this 180 calendar day period.

~~CONTRACTUAL OBLIGATIONS~~

~~For a discussion of our contractual obligations see (i) our Financial Statements and Notes to Consolidated Financial Statements Note 9.~~ ~~Commitments and Contingencies, and (ii) Item 7 Management Discussion and Analysis of Financial Condition and Results of Operations —~~ ~~Contractual Obligations and Commitments, included in our Annual Report on Form 10-K as of December 31, 2016.~~

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

~~Interest Rate Risk~~Not applicable.

Our primary exposure to market risk is interest income and expense sensitivity, which is affected by changes in the general level of interest rates, particularly because our equipment line of credit has a floating interest rate as of September 30, 2017. Changes in interest rates could affect the amounts of interest that we pay in the future.

Our cash and cash equivalent primary consists of deposits, and money market deposits managed by commercial banks as of September 30, 2017. The goals of our investment policy are preservation of capital, fulfillment of liquidity needs and fiduciary control of cash and investments.

Our investments are in short-term money marketable funds. Due to the short-term duration of our investment portfolio and the relatively low risk profile of our investments, a sudden change in interest rates would not have a material effect on the fair market value of our portfolio, nor our operating results or cash flows.

We do not believe our cash and cash equivalents have significant risk of default issues; however, we maintain significant amounts of cash and cash equivalents at one or more financial institutions that are in excess of federally insured limits. Given the current stability of financial institutions, we believe that we will not experience losses on these deposits.

~~Foreign Currency Risk~~

Our foreign currency exchange risk mainly arises from our operations in Italy. Our functional and reporting currency is the United States dollar. We translate our foreign operations’ assets and liabilities denominated in foreign currencies into U.S. dollars at current rates of exchange as of the balance sheet date and income and expense items at the average exchange rate for the reporting period. Translation adjustments resulting from exchange rate fluctuations are recorded in the cumulative translation account, a component of consolidated accumulated other comprehensive income. In addition, we face the foreign currency risk as a result of entering into transactions denominated in currencies other than U.S. dollars. Changes in foreign currency exchange rates can create foreign exchange gains or losses to us.

~~Effects of Inflation~~

~~We do not believe that inflation and changing prices during the nine months ended September 30, 2017 had a significant impact on our results of operations.~~

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

We have performed an evaluation under the supervision and with the participation of our management, including our principal executive officer (CEO) and principal financial officer (CFO), of the effectiveness of our disclosure controls and procedures, as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of September 30, ~~2017~~2021 to provide reasonable assurance that information required to be disclosed by us in the reports filed or submitted by us under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.

Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their objectives as specified above. Management does not expect, however, that our disclosure controls and procedures will prevent or detect all errors and fraud. Any control system, no matter how well designed and operated, is based upon certain assumptions and can provide only reasonable, not absolute, assurance that its objectives will be met. Further, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, within ~~the Company~~our company have been detected.

Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting during the three months ended September 30, ~~2017~~2021 that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Table of Contents

PART II. OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

~~See Note 9 to the unaudited Condensed Consolidated Financial Statements for a summary of legal proceedings.~~None.

ITEM 1A. RISK FACTORS

There have been no material changes from the risk factors disclosed in our Form 10-K for the year ended December 31, ~~2016, Form 10-Q for the periods ended March 31, 2017, and Form 10-Q for the periods ended June 30, 2017, except for the following:~~2020.

Our financial statements include an explanatory paragraph that expresses substantial doubt about our ability to continue as a going concern, indicating the possibility that we may not be able to operate in the future.

Primarily as a result of our losses incurred to date, our expected continued future losses, and limited cash balances, we have included an explanatory paragraph in our financial statements expressing substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern is contingent upon, among other factors, the sale of the shares of our common stock or obtaining alternate financing.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5. OTHER INFORMATION

None.

ITEM 6. EXHIBITS


Exhibit Number		Description of Exhibit


~~Exhibit~~ ~~Number~~		~~Description of Exhibit~~

~~4.1~~ 31.1		~~Stock Award Agreement dated August 15, 2017 by and between Trovagene, Inc. and William J. Welch.~~

~~31.1~~	Certification of Principal Executive Officer ~~and~~required by Rule 13a-14(a)/15d-14(a) under the Exchange Act.

31.2		Certification of Principal Financial Officer required by Rule 13a-14(a)/15d-14(a) under the Exchange Act.

32.1		Certification of Principal Executive Officer ~~and~~pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2		Certification of Principal Financial Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS		Inline XBRL Instance Document

101.SCH		Inline XBRL Taxonomy Extension Schema

101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase

101.LAB		Inline XBRL Taxonomy Extension Labels Linkbase

101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase

101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase

104		Cover Page Interactive Data File - the cover page from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 is formatted in Inline XBRL

Table of Contents

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.


		CARDIFF ONCOLOGY, INC.

November 4, 2021		~~TROVAGENE, INC.~~By:	/s/ Mark Erlander
			Mark Erlander
~~November 9, 2017~~		~~By:~~	~~/s/ William J. Welch~~
	~~William J. Welch~~
	Chief Executive Officer ~~(Principal Executive~~

		CARDIFF ONCOLOGY, INC.

November 4, 2021		By:	/s/ James Levine
			James Levine
			Chief Financial Officer ~~and Principal Financial Officer)~~



Delaware						27-2004382
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification No.)

11055 Flintkote Avenue, ~~Suite B,~~ San Diego, California						92121
(Address of principal executive offices)						(Zip Code)

(858) 952-7570
(Registrant’s telephone number, including area code)


				Page
PART I		FINANCIAL INFORMATION

			~~Page~~
~~PART I~~	~~FINANCIAL INFORMATION~~

Item 1.	Financial Statements (unaudited)

		Condensed ~~Consolidated~~ Balance Sheets ~~(unaudited) as of September 30, 2017 and December 31, 2016~~		3

		Condensed ~~Consolidated~~ Statements of Operations ~~(unaudited) for the three and nine months ended September 30, 2017 and 2016~~		4

		Condensed ~~Consolidated~~ Statements of Comprehensive Loss ~~(unaudited) for the three and nine months ended September 30, 2017 and 2016~~		5

		Condensed ~~Consolidated~~Statements of Stockholders’ Equity		6

		Condensed Statements of Cash Flows ~~(unaudited) for the nine months ended September 30, 2017 and 2016~~		69

		Notes to Condensed ~~Consolidated~~ Financial Statements ~~(unaudited)~~		711

Item 2.		Management’s Discussion and Analysis of Financial Condition and Results of Operations		1820

Item 3.		Quantitative and Qualitative Disclosures About Market Risk		2827

Item 4.		Controls and Procedures		2927

PART II		OTHER INFORMATION

Item 1.		Legal Proceedings		3028

Item 1A.		Risk Factors		3028

Item 2.		Unregistered Sales of Equity Securities and Use of Proceeds		3028

Item 3.		Defaults Upon Senior Securities		3028

Item 4.		Mine Safety Disclosures		3028

Item 5.		Other Information		3028

Item 6:		Exhibits		3028

SIGNATURES


	September 30, 2017			December 31, 2016				September 30, 2021		December 31, 2020
Assets							Assets
Current assets:							Current assets:
Cash and cash equivalents	$	7,434,298		$	13,915,094		Cash and cash equivalents	$	13,165	$	130,981
Short-term investments	—			23,978,022			Short-term investments	120,882		—
Accounts receivable	178,127			100,460
Accounts receivable and unbilled receivable							Accounts receivable and unbilled receivable	395		320
Prepaid expenses and other current assets	939,200			956,616			Prepaid expenses and other current assets	3,327		2,055
Total current assets	8,551,625			38,950,192			Total current assets	137,769		133,356
Property and equipment, net	3,126,969			3,826,915			Property and equipment, net	383		624

Operating lease right-of-use assets							Operating lease right-of-use assets	3,017		343
Other assets	539,309			1,173,304			Other assets	143		404
Total Assets	$	12,217,903		$	43,950,411		Total Assets	$	141,312	$	134,727

Liabilities and Stockholders’ Equity							Liabilities and Stockholders’ Equity
Current liabilities:							Current liabilities:
Accounts payable	$	675,499		$	1,130,536		Accounts payable	$	396	$	1,366
Accrued expenses	2,620,250			4,021,365			Accrued expenses	4,010		3,851
Deferred rent	298,213			285,246
Current portion of long-term debt (in default)	1,488,041			2,360,109

Operating lease liabilities							Operating lease liabilities	594		860
Other current liabilities							Other current liabilities	42		42

Total current liabilities	5,082,003			7,797,256			Total current liabilities	5,042		6,119
Long-term debt, less current portion	—			14,176,359
Derivative financial instruments—warrants	2,037,712			834,940			Derivative financial instruments—warrants	5		285
Deferred rent, net of current portion	1,153,316			1,373,717

Operating lease liabilities, net of current portion							Operating lease liabilities, net of current portion	2,691		9

Other liabilities							Other liabilities	30		156
Total Liabilities	8,273,031			24,182,272			Total Liabilities	7,768		6,569

Commitments and contingencies (Note 9)
Commitments and contingencies (Note 8)							Commitments and contingencies (Note 8)	0		0

Stockholders’ equity							Stockholders’ equity
Preferred stock, $0.001 par value, 20,000,000 shares authorized; 60,600 shares outstanding at September 30, 2017 and December 31, 2016; designated as Series A Convertible Preferred Stock with liquidation preference of $606,000 at September 30, 2017 and December 31, 2016	60			60
Common stock, $0.0001 par value, 150,000,000 shares authorized; 38,105,251 and 30,696,791 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively	3,811			3,070
Preferred stock, 20,000 shares authorized; (Note 7)							Preferred stock, 20,000 shares authorized; (Note 7)	1		1
Common stock, $0.0001 par value, 150,000 shares authorized; 39,552 and 36,781 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively							Common stock, $0.0001 par value, 150,000 shares authorized; 39,552 and 36,781 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively	4		4
Additional paid-in capital	174,426,891			167,890,984			Additional paid-in capital	384,551		361,819
Accumulated other comprehensive loss	(15,194		)	(10,773		)
Service receivables							Service receivables	(666)		(2,171)
Accumulated other comprehensive income							Accumulated other comprehensive income	16		—
Accumulated deficit	(170,470,696		)	(148,115,202		)	Accumulated deficit	(250,362)		(231,495)
Total stockholders’ equity	3,944,872			19,768,139			Total stockholders’ equity	133,544		128,158
Total liabilities and stockholders’ equity	$	12,217,903		$	43,950,411		Total liabilities and stockholders’ equity	$	141,312	$	134,727


	Nine Months Ended September 30,
	2021		2020
Operating activities
Net loss	$	(18,849)	$	(12,710)
Adjustments to reconcile net loss to net cash used in operating activities:
Loss on disposal of assets	1		—
Impairment loss	—		34
Depreciation	338		349
Stock-based compensation expense	2,244		821




Amortization of premiums on short-term investments	1,160		—


Change in fair value of derivative financial instruments—warrants	(280)		186
Release of clinical trial funding commitment	1,505		868
Changes in operating assets and liabilities:
Other assets	261		2
Accounts receivable and unbilled receivable	(74)		(1)
Prepaid expenses and other assets	(741)		(624)
Operating lease right-of-use assets	386		240
Accounts payable and accrued expenses	(830)		320
Operating lease liabilities	(645)		(636)
Other liabilities	(126)		(40)
Net cash used in operating activities	(15,650)		(11,191)

Investing activities:

Capital expenditures	(98)		(154)
Maturities of short-term investments	15,101		—
Purchases of short-term investments	(146,632)		—
Sales of short-term investments	8,975		—
Net cash used in investing activities	(122,654)		(154)

Financing activities:
Proceeds from sales of common stock, preferred stock and warrants, net of expenses of $776 and $634, respectively	19,225		18,279

Costs related to the clinical trial funding commitment	—		(8)
Proceeds from exercise of options	—		7
Proceeds from exercise of warrants	1,263		18,972

Borrowings under note payable	—		305



Net cash provided by financing activities	20,488		37,555

Net change in cash and cash equivalents	(117,816)		26,210
Cash and cash equivalents—Beginning of period	130,981		10,195
Cash and cash equivalents—End of period	$	13,165	$	36,405

Supplementary disclosure of cash flow activity:
Cash paid for taxes	$	1	$	1

Supplemental disclosure of non-cash investing and financing activities:



	Nine Months Ended September 30,
	2017			2016
Operating activities
Net loss	$	(22,337,314	)	$	(30,656,068	)
Adjustments to reconcile net loss to net cash used in operating activities:
Loss on disposal of assets	28,199			—
Impairment loss	485,000			—
Depreciation and amortization	956,995			693,485
Stock based compensation expense	3,117,364			5,942,392
Loss on extinguishment of debt	1,655,825			—
Accretion of final fee premium	293,614			266,423
Amortization of discount on debt	113,780			105,710
Net realized loss on short-term investments	6,400			—
Amortization of premiums on short-term investments	9,230			61,719
Deferred rent	(207,435		)	(133,378		)
Interest income accrued on short-term investments	(90,330		)	10,122
Change in fair value of derivative financial instruments—warrants	(2,012,747		)	(674,834		)
Changes in operating assets and liabilities:
Decrease in other assets	—			2,761
(Increase) decrease in accounts receivable	(77,667		)	13,584
Decrease (increase) in prepaid expenses and other current assets	18,230			(157,051		)
(Decrease) increase in accounts payable and accrued expenses	(1,908,796		)	2,490,137
Net cash used in operating activities	(19,949,652		)	(22,034,998		)

Investing activities:
Capital expenditures, net	(136,251		)	(797,781		)
Maturities of short-term investments	16,431,837			—
Purchases of short-term investments	(8,804,604		)	(24,451,611		)
Sales of short-term investments	16,434,553			—
Net cash provided by (used in) investing activities	23,925,535			(25,249,392		)

Financing activities:
Proceeds from sales of common stock and warrants, net of expenses	6,634,803			2,293,857
Proceeds from exercise of options	—			366,966
Borrowings under equipment line of credit	—			792,251
Borrowings under long-term debt, net of costs	—			7,805,086
Payment upon debt extinguishment	(1,613,067		)	—
Repayments of long-term debt	(15,000,000		)	(8,896,166		)
Repayments of equipment line of credit	(469,578		)	—
Net cash (used in) provided by financing activities	(10,447,842		)	2,361,994
Effect of exchange rate changes on cash and cash equivalents	(8,837		)	(1,544		)
Net change in cash and equivalents	(6,480,796		)	(44,923,940		)
Cash and cash equivalents—Beginning of period	13,915,094			67,493,047
Cash and cash equivalents—End of period	$	7,434,298		$	22,569,107

Supplementary disclosure of cash flow activity:
Cash paid for taxes	$	800		$	4,560
Cash paid for interest	$	650,331		$	806,228
Supplemental disclosure of non-cash investing and financing activities:
Preferred stock dividends accrued	$	18,180		$	18,180
Leasehold improvements paid for by lessor	$	—		$	1,860,000



x☒			QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934



o☐			TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934



	Three Months Ended September 30,						Nine Months Ended September 30,
	2017			2016			2017			2016
Numerator: Net loss attributable to common shareholders	$	(4,298,026	)	$	(10,197,332	)	$	(22,355,494	)	$	(30,674,248	)
Adjustment for gain from change in fair value of derivative financial instruments—warrants	—			—			—			(533,750		)
Net loss used for diluted loss per share	$	(4,298,026	)	$	(10,197,332	)	$	(22,355,494	)	$	(31,207,998	)
Denominator for basic and diluted net loss per share:
Weighted-average shares used to compute basic loss per share	36,465,672			30,339,774			32,826,306			30,018,841
Adjustments to reflect assumed exercise of warrants	—			—			—			117,731
Weighted-average shares used to compute diluted net loss per share	36,465,672			30,339,774			32,826,306			30,136,572
Net loss per share attributable to common stockholders:
Basic	$	(0.12	)	$	(0.34	)	$	(0.68	)	$	(1.02	)
Diluted	$	(0.12	)	$	(0.34	)	$	(0.68	)	$	(1.04	)


	September 30,
	2021	2020
Options to purchase Common Stock	3,566,832	1,920,706
Warrants to purchase Common Stock	4,490,159	7,373,351
Restricted Stock Units	—	991
Series A Convertible Preferred Stock	877	877

Series E Convertible Preferred Stock	2,684,607	3,548,459
	10,742,475	12,844,384



Description	Balance at December 31, 2016		Issuance of Derivative Financial Instruments	Realized Gain			Balance at September 30, 2017
Derivative financial instruments—warrants	$	834,940	3,215,519	$	(2,012,747	)	$	2,037,712



	December 31, 2016
				Unrealized
	Maturity in Years	Cost		Gains		Losses			Fair Value
Corporate debt securities	Less than 1 year	$	14,165,915	$	44	$	(5,273	)	$	14,160,686
Commercial paper	Less than 1 year	1,195,444		—		—			1,195,444
U.S. treasury securities	Less than 1 year	8,625,728		330		(4,166		)	8,621,892
Total Investment		$	23,987,087	$	374	$	(9,439	)	$	23,978,022


	As of September 30, 2021			As of December 31, 2020
Fair value of Cardiff Oncology common stock	$	6.66		$	17.99
Expected warrant term	1.3 years			2.1 years
Risk-free interest rate	0.15		%	0.13		%
Expected volatility of Cardiff Oncology common stock	100		%	116		%
Dividend yield	0		%	0		%



Date	Description	Number of Warrants	Derivative Instrument Liability
December 31, 2016	Balance of derivative financial instruments—warrants liability	967,295	$	834,940
	Issuance of derivative financial instruments	4,643,626	3,215,519
	Change in fair value of derivative financial instruments—warrants during the period recognized as a gain in the condensed consolidated statements of operations	—	(2,012,747		)
September 30, 2017	Balance of derivative financial instruments—warrants liability	5,610,921	$	2,037,712


(in thousands, except for number of warrants)
Date	Description	Number of Warrants	Derivative Instrument Liability
December 31, 2020	Balance of derivative financial instruments—warrants liability	64,496	$	285

	Change in fair value of derivative financial instruments—warrants during the period recognized as a gain in the condensed statements of operations	—	(280)
September 30, 2021	Balance of derivative financial instruments—warrants liability	64,496	$	5



	Three Months Ended September 30,				Nine Months Ended September 30,
	2017		2016		2017			2016
Included in research and development expense	$	219,480	$	872,792	$	798,143		$	1,862,069
Included in cost of revenue	15,633		42,639		56,998			99,164
Included in selling and marketing expense	118,434		476,865		550,317			1,493,744
Included in general and administrative expense	1,067,633		437,075		1,837,128			2,487,415
Benefit from restructuring	—		—		(125,222		)	—
Total stock-based compensation expense	$	1,421,180	$	1,829,371	$	3,117,364		$	5,942,392


								Total Options	Weighted-Average Exercise Price Per Share		Intrinsic Value
Balance outstanding, December 31, 2020							Balance outstanding, December 31, 2020	1,860,507	$	7.43	$	27,963,363
Granted							Granted	1,721,314	$	7.48
	Total Options		Weighted-Average Exercise Price Per Share		Intrinsic Value
Balance outstanding, December 31, 2016	5,528,628		$	5.49	$	—
Granted	823,106		$	0.84
Canceled / Forfeited	(2,077,246	)	$	6.24			Canceled / Forfeited	(10,770)	$	2.55
Expired	(17,457	)	$	4.74			Expired	(4,219)	$	216.00
Balance outstanding, September 30, 2017	4,257,031		$	4.23	$	381
Exercisable at September 30, 2017	2,492,242		$	4.79	$	—
Balance outstanding, September 30, 2021							Balance outstanding, September 30, 2021	3,566,832	$	7.22	$	7,522,769
Exercisable at September 30, 2021							Exercisable at September 30, 2021	1,281,604	$	8.96	$	5,103,890
Vested and expected to vest at September 30, 2021							Vested and expected to vest at September 30, 2021	3,466,323	$	7.28	$	7,344,075


	Total Restricted Stock Units	Weighted-Average Grant Date Fair Value Per Share		Intrinsic Value
Non-vested RSUs outstanding, December 31, 2020	491	$	147.60	$	8,833

Vested	(491)	$	147.60

Non-vested RSUs outstanding, September 30, 2021	—	$	—	$	—



	Number of Shares		Weighted-Average Grant Date Fair Value Per Share		Intrinsic Value
Non-vested RSU outstanding, December 31, 2016	272,000		$	3.99	$	571,200
Granted	2,249,242		$	1.59
Vested	(369,487	)	$	3.48	$	645,775
Forfeited	(874,453	)	$	1.75
Non-vested RSU outstanding, September 30, 2017	1,277,302		$	1.44	$	932,430


	Total Warrants	Weighted-Average Exercise Price Per Share		Weighted-Average Remaining Contractual Term
Balance outstanding, December 31, 2020	5,260,992	$	5.19	4.1 years

Exercised	(770,833)	$	1.64

Balance outstanding, September 30, 2021	4,490,159	$	5.80	3.2 years