Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 19, 2024 | Jun. 30, 2023 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Transition Report | false | ||
Entity File Number | 001-38128 | ||
Entity Registrant Name | Checkpoint Therapeutics, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 47-2568632 | ||
Entity Address, Address Line One | 95 Sawyer Road | ||
Entity Address, Address Line Two | Suite 110 | ||
Entity Address, City or Town | Waltham | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02453 | ||
City Area Code | 781 | ||
Local Phone Number | 652-4500 | ||
Title of 12(b) Security | Common Stock, par value $0.0001 per | ||
Trading Symbol | CKPT | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 33,088,814 | ||
Entity Central Index Key | 0001651407 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Auditor Name | KPMG, LLP | ||
Auditor Location | Boston, MA | ||
Auditor Firm ID | 185 | ||
Class A Common Stock | |||
Document and Entity Information | |||
Entity Common Stock, Shares Outstanding | 700,000 | ||
Common Stock | |||
Document and Entity Information | |||
Entity Common Stock, Shares Outstanding | 34,986,279 |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current Assets: | ||
Cash and cash equivalents | $ 4,928 | $ 12,068 |
Prepaid expenses and other current assets | 450 | 1,149 |
Other receivables - related party | 73 | |
Total current assets | 5,378 | 13,290 |
Total Assets | 5,378 | 13,290 |
Current Liabilities: | ||
Accounts payable and accrued expenses | 15,485 | 20,297 |
Accounts payable and accrued expenses - related party | 2,815 | 1,306 |
Common stock warrant liabilities | 125 | 11,170 |
Total current liabilities | 18,425 | 32,773 |
Total Liabilities | 18,425 | 32,773 |
Commitments and Contingencies (note 5) | ||
Stockholders' Equity (Deficit) | ||
Common stock issuable, 1,492,915 and 368,907 shares as of December 31, 2023 and December 31, 2022, respectively | 3,419 | 1,885 |
Additional paid-in capital | 297,864 | 241,117 |
Accumulated deficit | (314,333) | (262,486) |
Total Stockholders' Equity (Deficit) | (13,047) | (19,483) |
Total Liabilities and Stockholders' Equity (Deficit) | 5,378 | 13,290 |
Common No Class | ||
Stockholders' Equity (Deficit) | ||
Common Stock Value | $ 3 | $ 1 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 | Nov. 03, 2022 | Nov. 02, 2022 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Common stock, shares authorized | 80,000,000 | 50,000,000 | 80,000,000 | 30,000,000 |
Common stock, shares issued | 27,042,035 | 9,586,683 | ||
Common stock, shares outstanding | 27,042,035 | 9,586,683 | ||
Common stock, shares subscribed but unissued | 1,492,915 | 368,907 | ||
Class A Common Shares | ||||
Common stock, shares issued | 700,000 | 700,000 | ||
Common stock, shares outstanding | 700,000 | 700,000 |
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
STATEMENTS OF OPERATIONS | ||
Revenue - related party | $ 103 | $ 192 |
Revenue, Related Party, Type [Extensible Enumeration] | us-gaap:RelatedPartyMember | us-gaap:RelatedPartyMember |
Operating expenses: | ||
Research and development | $ 43,566 | $ 49,825 |
General and administrative | 8,685 | 8,700 |
Total operating expenses | 52,251 | 58,525 |
Loss from operations | (52,148) | (58,333) |
Other income (loss): | ||
Interest income | 84 | 160 |
Gain (loss) on common stock warrant liabilities | 217 | (4,451) |
Total other income (loss) | 301 | (4,291) |
Net Loss | $ (51,847) | $ (62,624) |
Loss per Share: | ||
Basic net loss per common share outstanding | $ (3.17) | $ (7.09) |
Diluted net loss per common share outstanding | $ (3.17) | $ (7.09) |
Basic weighted average number of common shares outstanding | 18,742,494 | 8,835,521 |
Diluted weighted average number of common shares outstanding | 18,742,494 | 8,835,521 |
STATEMENTS OF STOCKHOLDERS' EQU
STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Common Shares Class A Common Shares | Common Shares | Common Shares Issuable | Additional Paid-in Capital | Accumulated Deficit | Total |
Balances at Dec. 31, 2021 | $ 1 | $ 6,598 | $ 223,009 | $ (199,862) | $ 29,746 | |
Balances (in Shares) at Dec. 31, 2021 | 700,000 | 7,757,440 | ||||
Issuance of common shares, net of offering costs - At-the-market offering | 9,872 | 9,872 | ||||
Issuance of common shares, net of offering costs - At-the-market offering (in Shares) | 532,816 | |||||
Issuance of common shares, net of offering costs - Registered direct offering (in Shares) | 950,000 | |||||
Issuance of common shares - Founders Agreement | (6,598) | 7,016 | 418 | |||
Issuance of common shares - Founders Agreement (in Shares) | 268,813 | |||||
Common shares issuable - Founders Agreement | 1,885 | 1,885 | ||||
Stock-based compensation expense | 2,924 | 2,924 | ||||
Stock-based compensation expense (in Shares) | 143,571 | |||||
Net settlement of shares withheld for payment of employee taxes | (1,698) | (1,698) | ||||
Net settlement of shares withheld for payment of employee taxes (in shares) | (64,856) | |||||
Fractional share adjustment | (6) | (6) | ||||
Fractional share adjustment (in shares) | (1,101) | |||||
Net loss | (62,624) | (62,624) | ||||
Balances at Dec. 31, 2022 | $ 0 | $ 1 | 1,885 | 241,117 | (262,486) | (19,483) |
Balances (in Shares) at Dec. 31, 2022 | 700,000 | 9,586,683 | ||||
Issuance of common shares, net of offering costs - Registered direct offering | $ 1 | 30,124 | 30,125 | |||
Issuance of common shares, net of offering costs - Registered direct offering (in Shares) | 6,957,186 | |||||
Issuance of common shares - Founders Agreement | (1,885) | 2,837 | 952 | |||
Issuance of common shares - Founders Agreement (in Shares) | 767,567 | |||||
Common shares issuable - Founders Agreement | 3,419 | 3,419 | ||||
Stock-based compensation expense | 2,897 | 2,897 | ||||
Stock-based compensation expense (in Shares) | 1,091,098 | |||||
Exercise of prefunded and common stock warrants, including inducement | $ 1 | 20,889 | 20,890 | |||
Exercise of prefunded and common stock warrants, including inducements (in shares) | 8,639,501 | |||||
Net loss | (51,847) | (51,847) | ||||
Balances at Dec. 31, 2023 | $ 0 | $ 3 | $ 3,419 | $ 297,864 | $ (314,333) | $ (13,047) |
Balances (in Shares) at Dec. 31, 2023 | 700,000 | 27,042,035 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash Flows from Operating Activities: | ||
Net loss | $ (51,847) | $ (62,624) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 2,897 | 2,924 |
Issuance of common shares - Founders Agreement | 952 | 418 |
Common shares issuable - Founders Agreement | 3,419 | 1,885 |
(Gain) loss on common stock warrant liabilities | (217) | 4,451 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 699 | (173) |
Other receivables - related party | 73 | (56) |
Accounts payable and accrued expenses | (5,075) | (4,622) |
Accounts payable and accrued expenses - related party | 1,509 | 243 |
Net cash used in operating activities | (47,590) | (57,554) |
Cash Flows from Financing Activities: | ||
Proceeds from issuance of common shares | 7,500 | |
Net settlement of shares withheld for payment of employee taxes | 0 | (1,698) |
Payment of Fractional shares | 0 | (6) |
Cash received for exercise of warrants | 11,134 | |
Payment of transactional costs for exercise of warrants | (1,016) | |
Net cash provided by financing activities | 40,450 | 14,887 |
Net decrease in cash and cash equivalents | (7,140) | (42,667) |
Cash and cash equivalents at beginning of period | 12,068 | 54,735 |
Cash and cash equivalents at end of period | 4,928 | 12,068 |
Supplemental disclosure of noncash investing and financing activities: | ||
Issuance of common shares - Founders Agreement | 1,885 | 6,598 |
Issuance of common shares - Registered direct offerings (offering costs incurred but not paid) | 207 | |
Warrant inducement (transactional costs incurred but not paid) | 56 | |
Registered direct offerings | ||
Cash Flows from Financing Activities: | ||
Proceeds from issuance of common shares | 33,621 | 7,500 |
Payment of offering costs for the issuance of common shares | (3,289) | (781) |
At-the-market offering | ||
Cash Flows from Financing Activities: | ||
Proceeds from issuance of common shares | 0 | 10,120 |
Payment of offering costs for the issuance of common shares | $ 0 | $ (248) |
Organization and Description of
Organization and Description of Business Operations | 12 Months Ended |
Dec. 31, 2023 | |
Organization and Description of Business Operations | |
Organization and Description of Business Operations | Note 1 - Organization and Description of Business Operations Checkpoint Therapeutics, Inc. (the “Company” or “Checkpoint”) was incorporated in Delaware on November 10, 2014. Checkpoint is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. The Company may acquire rights to these technologies by licensing the rights or otherwise acquiring an ownership interest in the technologies, funding their research and development and eventually either out-licensing or bringing the technologies to market. The Company is a majority-controlled subsidiary of Fortress Biotech, Inc. (“Fortress”). The Company’s common stock is listed on the NASDAQ Capital Market and trades under the symbol “CKPT.” December 2022 Reverse Stock Split On November 3, 2022, the holders of a majority of the voting power of the common stock of the Company executed a written consent approving a grant of discretionary authority to the board of directors of the Company (the “Board”) to, without further stockholder approval, (i) effect a 1: 10 Pursuant to rules adopted by the Securities and Exchange Commission (“SEC”) under the Securities Exchange Act of 1934, a Schedule 14C information statement was filed with the SEC and provided to the stockholders of the Company. The Reverse Stock Split became effective on December 6, 2022, or twenty (20) days from the mailing of the information statement to the common stockholders of record. The Authorized Share Reduction also became effective on December 6, 2022 per the Certificate Amendment filed with the Secretary of State of the State of Delaware. All share and per share information has been retroactively adjusted to give effect to the Reverse Stock Split for all periods presented, unless otherwise indicated. Proportionate adjustments were made to the per share exercise price and/or the number of shares issuable upon the exercise or vesting of all stock options, restricted stock and warrants outstanding at December 6, 2022, which resulted in a proportional decrease in the number of shares of the Company’s common stock reserved for issuance upon exercise or vesting of such stock options, restricted stock and warrants, and, in the case of stock options and warrants, a proportional increase in the exercise price of all such stock options and warrants. No fractional shares were issued in connection with the Reverse Stock Split and stockholders who would otherwise be entitled to a fraction of one share received a proportional cash payment. Liquidity, Capital Resources and Going Concern The Company has incurred substantial operating losses since its inception and expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. As of December 31, 2023, the Company had an accumulated deficit of $314.3 million. In December 2022, the Company closed on a registered direct offering (the “December 2022 Registered Direct Offering”) for the issuance and sale of an aggregate of 950,000 shares of our common stock at a purchase price of $4.325 per share. In addition, the offering included 784,105 shares of common stock in the form of pre - funded warrants at a price of $4.3249. The common stock and the pre - funded warrants were sold together with Series A warrants to purchase up to 1,734,105 shares of common stock and Series B warrants to purchase up to 1,734,105 shares of common stock. The Series A warrants are exercisable immediately upon issuance and will expire five years following the issuance date and have an exercise price of $4.075 per share and the Series B warrants are exercisable immediately upon issuance and will expire eighteen months following the issuance date and have an exercise price of $4.075 per share. Total gross proceeds from the December 2022 Registered Direct Offering were $7.5 million with net proceeds of approximately $6.7 million after deducting approximately $0.8 million in commissions and other transaction costs. In February 2023, the Company closed on a registered direct offering (the “February 2023 Registered Direct Offering”) for the issuance and sale of an aggregate of 1,180,000 shares of its common stock at a purchase price of $5.25 per share in a registered direct offering. In addition, the offering includes 248,572 shares of common stock in the form of pre-funded warrants at a price of $5.2499. In a concurrent private placement, Checkpoint issued and sold Series A warrants to purchase up to 1,428,572 shares of common stock and Series B warrants to purchase up to 1,428,572 shares of common stock. The Series A and B warrants are exercisable In April 2023, the Company closed on a registered direct offering (the “April 2023 Registered Direct Offering”) for the issuance and sale of an aggregate of 1,700,000 shares of its common stock at a purchase price of $3.60 per share of common stock in a registered direct offering. In a concurrent private placement, Checkpoint issued and sold Series A warrants to purchase up to 1,700,000 shares of common stock and Series B warrants to purchase up to 1,700,000 shares of common stock. The Series A and B warrants are exercisable In May 2023, the Company closed on a registered direct offering (the “May 2023 Registered Direct Offering”) for the issuance and sale of an aggregate of 1,650,000 shares of its common stock at a purchase price of $3.071 per share of common stock in a registered direct offering. In addition, the offering includes 1,606,269 shares of common stock in the form of pre-funded warrants at a price of $3.0709. The common stock and the pre-funded warrants were sold together with Series A warrants to purchase up to 3,256,269 shares of common stock and Series B warrants to purchase up to 3,256,269 shares of common stock. The Series A and B warrants are exercisable In July 2023, the Company closed on a registered direct offering (the “July 2023 Registered Direct Offering”) for the issuance and sale of an aggregate of 2,427,186 shares of its common stock at a purchase price of $3.09 per share of common stock in a registered direct offering. In addition, the offering includes 809,062 shares of common stock in the form of pre-funded warrants at a price of $3.0899. The common stock and the pre-funded warrants were sold together with Series A warrants to purchase up to 3,236,248 shares of common stock and Series B warrants to purchase up to 3,236,248 shares of common stock. The Series A and B warrants are exercisable In October 2023, the Company entered into an inducement offer letter agreement (the “October 2023 Inducement”) with a certain holder of its existing warrants to exercise for cash an aggregate of 6,325,354 shares of the Company’s common stock at a reduced exercise price of $1.76 per share. The warrants were issued to the holder as part of the December 2022 Registered Direct Offering with an exercise price of $4.075 per share and as part of the February 2023 Registered Direct Offering with an exercise price of $5.00 per share. As part of the October 2023 Inducement, the Company agreed to issue new unregistered Series A Warrants to purchase up to 6,325,354 shares of Common Stock and new unregistered Series B Warrants to purchase up to 6,325,354 shares of Common Stock (collectively, the “October 2023 Common Stock Warrants”). The October 2023 Common Stock Warrants are exercisable $11.1 million with net proceeds of approximately $10.0 million after deducting approximately $1.1 million in commissions and other transaction costs. The Company expects to continue to use the proceeds from previous financing transactions primarily for general corporate purposes, which may include financing the Company’s growth, developing new or existing product candidates, and funding capital expenditures, acquisitions and investments. In accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern The Company believes that its cash and cash equivalents are only sufficient to fund its operating expenses into the third quarter of 2024. The Company has suffered recurring losses from operations and has a net capital deficiency that raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date that these financial statements are issued. Management's plans to alleviate the conditions that raise substantial doubt include reduced 2024 spending, including projected savings through delaying the development timelines of certain programs and the pursuit of additional cash resources through public or private equity or debt financings and potential partnerships. Management has concluded the likelihood that its plan to successfully obtain sufficient funding from one or more of these sources, or adequately reduce expenditures, while reasonably possible, is less than probable. Accordingly, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least 12 months from the date of issuance of these financial statements. The Company’s estimate as to how long it expects its existing cash to be able to continue to fund its operations is based on assumptions that may prove to be wrong, and it could use its available capital resources sooner than it currently expects. Further, changing circumstances, some of which may be beyond its control, could cause the Company to consume capital faster than it currently anticipates, and it may need to seek additional funds sooner than planned. The Company cannot be certain that additional funding will be available to it on acceptable terms, or at all. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Significant Accounting Policies | |
Significant Accounting Policies | Note 2 - Significant Accounting Policies Basis of Presentation The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. The Company has no subsidiaries. Segments Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating and reporting Use of Estimates 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 expenses during the reporting period. Actual results could differ from those estimates. Cash and Cash Equivalents The Company considers highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Other Receivables - Related Party Other receivables consist of amounts due to the Company from TG Therapeutics, Inc. (“TGTX”), a related party, and are recorded at the invoiced amount. Effective September 30, 2023, the Company and TGTX agreed to mutually terminate the collaboration agreements. Research and Development Costs Research and development costs are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. Upfront and milestone payments due to third parties that perform research and development services on the Company’s behalf will be expensed as services are rendered or when the milestone is achieved. Research and development costs primarily consist of personnel related expenses, including salaries, benefits, travel, and other related expenses, stock-based compensation, payments made to third parties for license and milestone costs related to in-licensed products and technology, payments made to third party contract research organizations for preclinical and clinical studies, investigative sites for clinical trials, consultants, the cost of acquiring and manufacturing clinical trial materials, costs associated with regulatory filings, laboratory costs and other supplies. In accordance with ASC 730-10-25-1, Research and Development Annual Equity Fee Under the Founders Agreement with Checkpoint dated March 17, 2015 and amended and restated in July 2016 and October 2017 (the “Founders Agreement”), Fortress is entitled to an annual equity fee on January 1 of each year equal to 2.5% of fully diluted outstanding equity of the Company, payable in Checkpoint common shares (“Annual Equity Fee”). The Annual Equity Fee was part of the consideration payable for formation of the Company, identification of certain assets, including the license contributed to Checkpoint by Fortress (see Note 4). The Company records the Annual Equity Fee in connection with the Founders Agreement with Fortress as contingent consideration. Contingent consideration is recorded when probable and reasonably estimable. Due to the nature of the Company’s assets and stage of development, future share prices and shares outstanding cannot be estimated prior to the issuance of the Annual Equity Fee. Due to these uncertainties, the Company has concluded that it is unable to reasonably estimate the contingent consideration until shares are actually issued on January 1 of each year. Pursuant to the Founders Agreement, the Company issued 368,907 shares of common stock to Fortress for the Annual Equity Fee, representing 2.5% of the fully diluted outstanding equity of Checkpoint on January 1, 2023. Because the number of outstanding shares issuable to Fortress was determinable on January 1, 2023 prior to the issuance of the December 31, 2022 financial statements, the Company recorded approximately $1.9 million in research and development expense and a credit to Common shares issuable - Founders Agreement during the year ended December 31, 2022. Pursuant to the Founders Agreement, the Company will issue 1,492,915 shares of common stock to Fortress for the Annual Equity Fee, representing 2.5% of the fully diluted outstanding equity of Checkpoint on January 1, 2024. The Company did not have enough unreserved authorized shares under its certificate of incorporation on January 1, 2024 to issue the shares for the Annual Equity Fee. Therefore, in December 2023, Fortress and Checkpoint mutually agreed to defer the issuance until such time as certificate of incorporation has been amended in order to increase the number of authorized that may be issued thereunder. Because the number of outstanding shares issuable to Fortress was determinable on January 1, 2024 prior to the issuance of the December 31, 2023 financial statements, the Company recorded approximately $3.4 million in research and development expense and a credit to Common shares issuable - Founders Agreement during the year ended December 31, 2023. Stock-Based Compensation Expenses The Company expenses stock-based compensation over the requisite service period based on the estimated grant-date fair value of the awards and forfeiture rates. The Company accounts for forfeitures as they occur. The Company estimates the fair value of stock option grants using the Black-Scholes Model. The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. All stock-based compensation costs are recorded in general and administrative or research and development costs in the Statements of Operations based upon the underlying individual’s role at the Company. In addition, because some of the restricted stock, restricted stock units and options issued to employees, directors and consultants vest upon achievement of certain milestones, the total expense is uncertain. Compensation expense for such awards that vest upon the achievement of milestones is recognized when the achievement of such milestones is probable. Common Stock Warrant Liability The Company has issued freestanding warrants to purchase shares of its common stock in connection with its financing activities and accounts for them in accordance with applicable accounting guidance as either liabilities or as equity instruments depending on the specific terms of the warrant agreements. Warrants classified as liabilities are remeasured each period they are outstanding. Any resulting gain or loss related to the change in the fair value of the warrant liability is recognized in gain (loss) on common stock warrant liabilities, a component of other income (loss), in the Statements of Operations. The Company estimates the fair value of common stock warrant liabilities using the Black-Scholes Model. The assumptions used in calculating the fair value represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. Fair Value Measurement The Company follows the accounting guidance in ASC 820 for its fair value measurements of financial assets and liabilities measured at fair value on a recurring basis. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. The accounting guidance requires fair value measurements be classified and disclosed in one of the following three categories: Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Observable inputs other than Level 1 prices, for similar assets or liabilities that are directly or indirectly observable in the marketplace. Level 3: Unobservable inputs which are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. Certain of the Company’s financial instruments are not measured at fair value on a recurring basis but are recorded at amounts that approximate their fair value due to their liquid or short-term nature, such as accounts payable and accrued expenses. Revenue from Contracts with Customers The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers ● Step 1: Identify the contract with the customer ● Step 2: Identify the performance obligations in the contract ● Step 3: Determine the transaction price ● Step 4: Allocate the transaction price to the performance obligations in the contract ● Step 5: Recognize revenue when the company satisfies a performance obligation In order to identify the performance obligations in a contract with a customer, a company must assess the promised goods or services in the contract and identify each promised good or service that is distinct. A performance obligation meets ASC 606’s definition of a “distinct” good or service (or bundle of goods or services) if both of the following criteria are met: ● the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (i.e., the good or service is capable of being distinct). ● the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (i.e., the promise to transfer the good or service is distinct within the context of the contract). If a good or service is not distinct, the good or service is combined with other promised goods or services until a bundle of goods or services is identified that is distinct. The transaction price is the amount of consideration to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. When determining the transaction price, an entity must consider the effects of all of the following: ● variable consideration; ● constraining estimates of variable consideration; ● the existence of a significant financing component in the contract; ● noncash consideration; and ● consideration payable to a customer Variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The transaction price is allocated to each performance obligation on a relative standalone selling price basis. The transaction price allocated to each performance obligation is recognized when that performance obligation is satisfied, at a point in time or over time as appropriate. Revenue for a sales-based or usage-based royalty promised in exchange for a license of intellectual property is recognized only when (or as) the later of the following events occurs: a. the subsequent sale or usage occurs; and b. the performance obligation to which some or all of the sales-based or usage-based royalty has been allocated has been satisfied (or partially satisfied). Incremental contract costs are expensed when incurred when the amortization period of the asset that would have been recognized is one year or less; otherwise, incremental contract costs are recognized as an asset and amortized over time as services are provided to a customer. Income Taxes The Company records income taxes using the asset and liability method. Deferred income tax assets and liabilities are recognized for the future tax effects attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective income tax bases, and operating loss and tax credit carryforwards. The Company establishes a valuation allowance if management believes it is more likely than not that the deferred tax assets will not be recovered based on an evaluation of objective verifiable evidence. For tax positions that are more likely than not to be sustained upon audit, the Company recognizes the largest amount with a greater than 50% likely of being realized. The Company does not recognize any portion of the benefit for tax positions that are not more likely than not to be sustained upon audit. As of December 31, 2023 and December 31, 2022, the Company determined, based upon available evidence, that it is more likely than not that the net deferred tax asset will not be realized and, accordingly, has provided a full valuation allowance against its net deferred tax asset. Net Loss per Share Net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Net loss attributable to common stockholders consisted of net loss, as adjusted for deemed dividends. The Company recorded a deemed dividend for the modification of certain of its existing warrants and issuance of the October 2023 Common Stock Warrants of $7.5 million during the year ended December 31, 2023 (see Notes 1 and 6). Diluted net loss per share does not reflect the effect of shares of common stock to be issued upon the exercise of stock options and warrants, as their inclusion would be anti-dilutive. The following table summarizes potentially dilutive securities outstanding at December 31, 2023 and 2022 that were excluded from the computation of diluted net loss per share, as they would be anti-dilutive: December 31, 2023 2022 Warrants (Note 6) 30,097,671 3,573,492 Stock options (Note 6) 127,000 27,000 Unvested restricted stock awards (Note 6) 1,316,120 378,897 Unvested restricted stock units (Note 6) 615,884 85,000 Total 32,156,675 4,064,389 The unexercised pre-funded warrants from the December 2022 Registered Direct Offering were included in the December 31, 2022 computation of diluted net loss per share since the exercise price was $0.0001. The 1,134,000 shares held in abeyance from the October 2023 Inducement (see Note 6) as of December 31, 2023 were included in the December 31, 2023 computation of diluted net loss per share since no additional consideration is due upon issuance of the shares. Comprehensive Loss The Company has no components of comprehensive loss other than net loss. Thus, comprehensive loss is the same as net loss for the periods presented. Recent Accounting Standards In October 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) No. 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Updated and Simplification Initiative In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280) Improvements to Reportable Segment Disclosures Segment Reporting In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2023 | |
License Agreements | |
License Agreements | Note 3 - License Agreements Dana-Farber Cancer Institute In March 2015, the Company entered into an exclusive license agreement with Dana-Farber Cancer Institute (“Dana Farber”) to develop a portfolio of fully human immuno-oncology targeted antibodies targeting PD-L1, Glucocorticoid-induced TNFR-related protein (“GITR”) and Carbonic anhydrase IX (“CAIX”). Under the terms of the license agreement, the Company paid Dana-Farber an up-front licensing fee of $1.0 million and, on May 11, 2015, granted Dana-Farber 50,000 shares, valued at $32,500 or $0.65 per share. The license agreement included an anti-dilution clause that maintained Dana-Farber’s ownership at 5% until such time that the Company raised $10 million in cash in exchange for common shares. Pursuant to this provision, on September 30, 2015, the Company granted to Dana-Farber an additional 13,683 shares of common stock valued at approximately $0.6 million and the anti-dilution clause thereafter expired. Dana-Farber is eligible to receive payments of up to an aggregate of approximately $21.5 million for each licensed product upon the Company’s successful achievement of certain clinical development, regulatory and first commercial sale milestones. As of December 31, 2023, $5.0 million of these milestones have been expensed for the antibody targeting PD-L1. In addition, Dana-Farber is eligible to receive up to an aggregate of $60.0 million upon the Company’s successful achievement of certain sales milestones based on aggregate net sales, in addition to royalty payments based on a tiered low to mid-single digit percentage of net sales. Dana-Farber also receives an annual license maintenance fee of $50,000, which is creditable against future milestone payments or royalties. In connection with the license agreement with Dana-Farber, in March 2015 the Company entered into a collaboration agreement with TGTX, which was amended and restated in June 2019, to develop and commercialize the anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies. The Company retained the right to develop and commercialize these antibodies in solid tumors. Michael Weiss, Chairman of the Board of Directors of Checkpoint and Fortress’ Executive Vice Chairman, Strategic Development, is also the Executive Chairman, President and Chief Executive Officer and a stockholder of TGTX. Effective September 30, 2023, the Company and TGTX agreed to mutually terminate the collaboration agreement. For the years ended December 31, 2023 and 2022, the Company recognized approximately $58,000 and $121,000 respectively, in revenue from our collaboration agreement with TGTX in the Statements of Operations. Adimab, LLC In October 2015, Fortress entered into a collaboration agreement with Adimab, LLC (“Adimab”) to discover and optimize antibodies using their proprietary core technology platform. Under this agreement, Adimab optimized cosibelimab, the Company’s anti-PD-L1 antibody which it originally licensed from Dana-Farber. In January 2019, Fortress transferred the rights to the optimized antibody to the Company, and Checkpoint entered into a collaboration agreement directly with Adimab on the same day. Under the terms of the agreement, Adimab is eligible to receive additional payments from the Company up to an aggregate of approximately $2.5 million upon various filings for regulatory approvals to commercialize the product. In addition, Adimab is eligible to receive royalty payments from the Company based on a tiered low single digit percentage of net sales. In February 2023, the Company expensed a non-refundable milestone payment of $2.2 million to research and development expenses upon the United States Food and Drug Administration’s filing acceptance of the Company’s Biologics License Application for cosibelimab. NeuPharma, Inc. In March 2015, Fortress entered into an exclusive license agreement with NeuPharma, Inc. (“NeuPharma”) to develop and commercialize novel irreversible, 3rd generation EGFR inhibitors, including olafertinib, on a worldwide basis other than certain Asian countries. On the same date, Fortress assigned all of its right and interest in the EGFR inhibitors to the Company. Under the terms of the license agreement, the Company paid NeuPharma an up-front licensing fee of $1.0 million, and NeuPharma is eligible to receive additional payments of up to an aggregate of approximately $39.0 million upon the Company’s successful achievement of certain clinical development and regulatory milestones covering up to three indications, of which $22.5 million are due upon various regulatory approvals to commercialize the products. In addition, NeuPharma is eligible to receive payments of up to an aggregate of $40.0 million upon the Company’s successful achievement of certain sales milestones based on aggregate net sales across all indications, in addition to royalty payments based on a tiered mid to high-single digit percentage of net sales. Jubilant Biosys Limited In May 2016, the Company entered into a license agreement with Jubilant Biosys Limited (“Jubilant”), whereby the Company obtained an exclusive, worldwide license to Jubilant’s family of patents covering compounds that inhibit BET proteins such as BRD4, including CK-103. Under the terms of the license agreement, the Company paid Jubilant an up-front licensing fee of $2.0 million, and Jubilant is eligible to receive payments up to an aggregate of approximately $88.4 million upon the Company’s successful achievement of certain clinical development and regulatory milestones, of which $59.5 million are due upon various regulatory approvals to commercialize the products. In addition, Jubilant is eligible to receive payments up to an aggregate of $89.3 million upon the Company’s successful achievement of certain sales milestones based on aggregate net sales, in addition to royalty payments based on a tiered low to mid-single digit percentage of net sales. In connection with the license agreement with Jubilant, the Company entered into a sublicense agreement with TGTX, a related party, to develop and commercialize the compounds licensed in the field of hematological malignancies, while the Company retained the right to develop and commercialize these compounds in the field of solid tumors. Effective September 30, 2023, the Company and TGTX agreed to mutually terminate the sublicense agreement. For the years ended December 31, 2023 and 2022, the Company recognized approximately $46,000 and $70,000, respectively, in revenue related to the sublicense agreement in the Statements of Operations. The collaborations with TGTX each contained single material performance obligations under Topic 606, which was the granting of a license that is functional intellectual property. The Company’s performance obligations were satisfied at the point in time when TGTX had the ability to use and benefit from the right to use the intellectual property. The performance obligations of the original agreements were satisfied prior to the adoption of Topic 606. The performance obligation of the amendment to the collaboration agreement was satisfied in June 2019. |
Related Party Agreements
Related Party Agreements | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Agreements | |
Related Party Agreements | Note 4 - Related Party Agreements Founders Agreement and Management Services Agreement with Fortress Effective March 17, 2015, the Company entered into a Founders Agreement with Fortress, which was amended in July 2016 and October 2017. The Founders Agreement provides, that in exchange for the time and capital expended in the formation of Checkpoint and the identification of specific assets the acquisition of which resulted in the formation of a viable emerging growth life science company, the Company shall: (i) issue annually to Fortress, on January 1 of each year, shares of common stock equal to two and one-half percent (2.5)% of the fully diluted outstanding equity of Checkpoint at the time of issuance; (ii) pay an equity fee in shares of common stock, payable within five (5) business days of the closing of any equity or debt financing for Checkpoint or any of its respective subsidiaries that occurs after the effective date of the Founders Agreement and ending on the date when Fortress no longer has majority voting control in Checkpoint’s voting equity, equal to two and one-half percent (2.5)% of the gross amount of any such equity or debt financing; and (iii) pay a cash fee equal to four and one half percent (4.5)% of Checkpoint’s annual net sales, payable on an annual basis, within ninety (90) days of the end of each calendar year. In the event of a change in control (as it is defined in the Founders Agreement), Checkpoint will pay a one-time change in control fee equal to five times (5x) the product of (i) monthly net sales for the twelve (12) months immediately preceding the change in control and (ii) four and one-half percent (4.5)%. The Founders Agreement has a term of fifteen years, after which it automatically renews for one-year periods unless Fortress gives the Company notice of termination. The Founders Agreement will also automatically terminate upon a change of control. Effective March 17, 2015, the Company entered into a Management Services Agreement (the “MSA”) with Fortress. Pursuant to the terms of the MSA, for a period of five (5) years, Fortress will render advisory and consulting services to the Company. Services provided under the MSA may include, without limitation, (i) advice and assistance concerning any and all aspects of Checkpoint’s operations, clinical trials, financial planning and strategic transactions and financings and (ii) conducting relations on behalf of the Company with accountants, attorneys, financial advisors and other professionals (collectively, the “Services”). The Company is obligated to utilize clinical research services, medical education, communication and marketing services and investor relations/public relation services of companies or individuals designated by Fortress, provided those services are offered at market prices. However, the Company is not obligated to take or act upon any advice rendered from Fortress and Fortress shall not be liable for any of the Company’s actions or inactions based upon their advice. Fortress and its affiliates, including all members of its Board of Directors, have been contractually exempt from fiduciary duties to the Company relating to corporate opportunities. In consideration for the Services, the Company will pay Fortress an annual consulting fee of $0.5 million (the “Annual Consulting Fee”), payable in advance in equal quarterly installments on the first business day of each calendar quarter in each year, provided, however, that such Annual Consulting Fee shall be increased to $1.0 million for each calendar year in which the Company has net assets in excess of $100 million at the beginning of the calendar year. The MSA shall be automatically extended for additional five-year periods unless Fortress or the Company provides notice to the other party of its desire not to automatically extend the term. For the years ended December 31, 2023 and 2022, the Company recognized $0.5 million in expense in its Statements of Operations related to the MSA. Caribe BioAdvisors, LLC In December 2016, the Company entered into an advisory agreement effective January 1, 2017 with Caribe BioAdvisors, LLC (“Caribe”), owned by Michael Weiss, to provide the advisory services of Mr. Weiss as Chairman of the Board. Pursuant to the agreement, Caribe will be paid an annual cash fee of $60,000, in addition to any and all annual equity incentive grants paid to members of the board. In June 2023, Mr. Weiss assigned the agreement to Hawkins BioVentures, LLC. For each of the years ended December 31, 2023 and 2022, the Company recognized approximately $110,000 in expenses in its Statements of Operations related to the advisory agreement, including $50,000 in expenses related to annual equity incentive grants. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies | |
Commitments and Contingencies | Note 5 - Commitments and Contingencies Leases The Company is not a party to any leases for office space or equipment. License Agreements The Company has undertaken to make contingent milestone payments to the licensors of its portfolio of product candidates. In addition, the Company would pay royalties to such licensors based on a percentage of net sales of each product candidate following regulatory marketing approval (See Note 3). Litigation The Company recognizes a liability for a contingency when it is probable that liability has been incurred and when the amount of loss can be reasonably estimated. When a range of probable loss can be estimated, the Company accrues the most likely amount of such loss, and if such amount is not determinable, then the Company accrues the minimum of the range of probable loss. As of December 31, 2023 and 2022, there was no litigation against the Company. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity | |
Stockholders' Equity | Note 6 - Stockholders’ Equity Common Stock At the Company’s 2023 Annual Meeting of Stockholders held on June 12, 2023, its stockholders approved an amendment to its certificate of incorporation to increase the number of authorized shares of common stock available to issue by 30,000,000 to 80,000,000 with a par value of $0.0001 per share, of which 700,000 shares are designated as “Class A common stock.” The amendment was filed with the Secretary of State of the State of Delaware on June 14, 2023. As of December 31, 2023 and 2022, there were 700,000 shares of Class A common stock issued and outstanding to Fortress. Dividends are to be distributed pro-rata to the Class A and common stockholders. The holders of common stock are entitled to one vote per share of common stock held. The Class A common stockholders are entitled to a number of votes per share equal to 1.1 times a fraction, the numerator of which is the sum of the shares of outstanding common stock and the denominator of which is the number of shares of Class A common stock. Accordingly, the holder of shares of Class A common stock will be able to control or significantly influence all matters requiring approval by our stockholders, including the election of directors and the approval of mergers or other business combination transactions. Each share of Class A common stock is convertible, at the option of the holder thereof, into one (1) fully paid and non-assessable share of common stock subject to adjustment for stock splits and combinations. At the Market Issuance Sales Agreement In November 2020, the Company filed a shelf registration statement on Form S-3 (the “November 2020 S-3”), which was declared effective in December 2020 (File No. 333-251005). Under the S-3, the Company may sell up to a total of $100 million of its securities. In connection with the S-3, the Company entered into an At-the-Market Issuance Sales Agreement (the “ATM”) with Cantor Fitzgerald & Co., Ladenburg Thalmann & Co. Inc. and H.C. Wainwright & Co., LLC (each an “Agent” and collectively, the “Agents”) relating to the sale of shares of common stock. Under the ATM, the Company pays the Agents a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of common stock. During the year ended December 31, 2022, the Company sold a total of 532,816 shares of common stock under the ATM for aggregate total gross proceeds of approximately $10.1 million at an average selling price of $18.99 per share, resulting in net proceeds of approximately $9.9 million after deducting commissions and other transaction costs. Registered Direct Offerings In December 2022, the Company closed on the December 2022 Registered Direct Offering for the issuance and sale of an aggregate of 950,000 shares of its common stock at a purchase price of $4.325 per share of common stock. In addition, the offering includes 784,105 shares of common stock in the form of pre-funded warrants at a price of $4.33249. The pre-funded warrants were funded in full at closing except for a nominal exercise price of $0.0001 and are exercisable commencing on the closing date and will terminate when such pre-funded warrants are exercised in full. The common stock and the pre-funded warrants were sold together with Series A warrants to purchase up to 1,734,105 shares of common stock and Series B warrants to purchase up to 1,734,105 shares of common stock (collectively, the “December 2022 Common Stock Warrants”). The Series A and B warrants are exercisable In February 2023, the Company closed on the February 2023 Registered Direct Offering for the issuance and sale of an aggregate of 1,180,000 shares of its common stock at a purchase price of $5.25 per share of common stock. In addition, the offering includes 248,572 shares of common stock in the form of pre-funded warrants at a price of $5.2499. The pre-funded warrants were funded in full at closing except for a nominal exercise price of $0.0001 and are exercisable commencing on the closing date and will terminate when such pre-funded warrants are exercised in full. In a concurrent private placement, Checkpoint issued and sold Series A warrants to purchase up to 1,428,572 shares of common stock and Series B warrants to purchase up to 1,428,572 shares of common stock (collectively, the “February 2023 Common Stock Warrants”). The Series A and B warrants are exercisable In April 2023, the Company closed on the April 2023 Registered Direct Offering for the issuance and sale of an aggregate of 1,700,000 shares of its common stock at a purchase price of $3.60 per share of common stock. In a concurrent private placement, Checkpoint issued and sold Series A warrants to purchase up to 1,700,000 shares of common stock and Series B warrants to purchase up to 1,700,000 shares of common stock (collectively, the “April 2023 Common Stock Warrants”). The Series A and B warrants are exercisable The November 2020 Form S-3 expired in December 2023. In March 2023, the Company filed a shelf registration statement on Form S-3 (the “March 2023 S-3”), which was declared effective May 5, 2023 (File No. 333-270843). Under the March 2023 S-3, the Company may sell up to a total of $150 million of its securities. In May 2023, the Company closed on the May 2023 Registered Direct Offering for the issuance and sale of an aggregate of 1,650,000 shares of its common stock at a purchase price of $3.071 per share of common stock. In addition, the offering includes 1,606,269 shares of common stock in the form of pre-funded warrants at a price of $3.0709. The pre-funded warrants were funded in full at closing except for a nominal exercise price of $0.0001 and are exercisable commencing on the closing date and will terminate when such pre-funded warrants are exercised in full. The common stock and the pre-funded warrants were sold together with Series A warrants to purchase up to 3,256,269 shares of common stock and Series B warrants to purchase up to 3,256,269 shares of common stock (collectively, the “May 2023 Common Stock Warrants”). The Series A and B warrants are exercisable In July 2023, the Company closed on the July 2023 Registered Direct Offering for the issuance and sale of an aggregate of 2,427,186 shares of its common stock at a purchase price of $3.09 per share of common stock in a registered direct offering. In addition, the offering includes 809,062 shares of common stock in the form of pre-funded warrants at a price of $3.0899. The pre-funded warrants were funded in full at closing except for a nominal exercise price of $0.0001 and are exercisable commencing on the closing date and will terminate when such pre-funded warrants are exercised in full. The common stock and the pre-funded warrants were sold together with Series A warrants to purchase up to 3,236,248 shares of common stock and Series B warrants to purchase up to 3,236,248 shares of common stock (collectively, the “July 2023 Common Stock Warrants”). The Series A and B warrants are exercisable As of December 31, 2023, approximately $91.7 million of securities remain available for sale under the March 2023 Form S-3. Warrant Inducement In October 2023, the Company entered into the October 2023 Inducement with a holder of certain of its existing warrants to exercise for cash an aggregate of 6,325,354 shares of the Company’s common stock at a reduced exercise price of $1.76 per share. The exercised warrants included the December 2022 Common Stock Warrants with an original exercise price of $4.075 per share and the February Common Stock Warrants with an original exercise price of $5.00 per share. These warrants were issued as part of the December 2022 Registered Direct Offering and February 2023 Registered Direct Offering. As part of the October 2023 Inducement, the Company agreed to issue new unregistered Series A Warrants to purchase up to 6,325,354 shares of Common Stock and new unregistered Series B Warrants to purchase up to 6,325,354 shares of Common Stock. The Series A and B warrants are exercisable immediately upon issuance with an exercise price million in commissions and other transaction costs. In November 2023, the Company filed a registration statement on Form S-3 to register the October 2023 Common Stock Warrants and placement agent warrants, which was declared effective November 24, 2023 (File No. 333-275644). The October 2023 Common Stock Warrants and placement agent warrants met the criteria for equity classification. The December 2022 Common Stock Warrants, which were liability classified, were revalued on October 4, 2023 using Black-Scholes Model to calculate the difference in fair value as a result of the change in exercise price. The difference in fair value of $1.2 million was recorded as a loss on common stock warrant liabilities in the Statements of Operations. The issuance of the October 2023 Common Stock Warrants was also considered as part of the cost of the inducement and were valued using Black-Scholes Model and allocated between the December 2022 Common Stock Warrants and The February 2023 Common Stock Warrants on a weighted basis. The approximately $7.7 million allocated to the December 2022 Common Stock Warrants was recorded as loss on common stock warrant liabilities in the Statements of Operations with a corresponding offset to additional paid-in-capital (see Note 7). The February 2023 Common Stock Warrants, which were equity classified and treated under ASC 815-40, Derivatives and Hedging - Contracts in Entity’s Own Equity Upon the close of the transaction, the Company issued the holder 110,000 of the 6,325,354 shares of common stock that were issuable upon exercise of the existing warrants. Due to the beneficial ownership limitation provisions in the inducement offer letter agreement, the remaining 6,215,354 shares were initially unissued, and held in abeyance for the benefit of the holder until notice from the holder that the shares may be issued in compliance with the agreement. As of December 31, 2023, 1,134,000 shares remained in abeyance. These shares were fully issued to the holder in January 2024. Shares Issued Under the Founders Agreement Pursuant to the Founders Agreement, the Company issued to Fortress 2.5% of the aggregate number of shares of common stock issued in the offerings and warrant exercises noted above. Accordingly, the Company issued 398,660 shares and 56,671 shares to Fortress for the years ended December 31, 2023 and 2022, respectively, and recorded expenses of approximately $1.0 million and $0.4 million related to these stock grants, which is included in general and administrative expenses in the Company’s Statements of Operations for the years ended December 31, 2023 and 2022, respectively. Pursuant to the Founders Agreement, the Company issued 368,907 shares of common stock to Fortress for the Annual Equity Fee, representing 2.5% of the fully diluted outstanding equity of the Company on January 1, 2023. Pursuant to the Founders Agreement, the Company will issue 1,492,915 shares of common stock to Fortress for the Annual Equity Fee, representing 2.5% of the fully diluted outstanding equity of the Company on January 1, 2024. The Company did not have enough unreserved authorized shares under its certificate of incorporation on January 1, 2024 to issue the shares for the Annual Equity Fee. Therefore, in December 2023, Fortress and Checkpoint mutually agreed to defer the issuance until such time as the certificate of incorporation has been amended in order to increase the number of authorized shares that may be issued thereunder (see Notes 2 and 4). The Company may offer the securities under the S-3 from time to time in response to market conditions or other circumstances if it believes such a plan of financing is in the best interests of its stockholders. Equity Incentive Plan The Company has in effect the Amended and Restated 2015 Incentive Plan (“2015 Incentive Plan”). The 2015 Incentive Plan was adopted in March 2015 by our stockholders. Under the 2015 Incentive Plan, the compensation committee of the Company’s board of directors is authorized to grant stock-based awards to directors, officers, employees and consultants. An amendment to the 2015 Incentive Plan was approved by holders of a majority of the voting power of the common stock of the Company on November 17, 2023 to increase the shares available for issuance to 6,000,000 shares. The plan expires 10 years from the effective date of the amendment and limits the term of each option to no more than 10 years from the date of grant. As of December 31, 2023, 3,510,830 shares are available for issuance under the 2015 Incentive Plan. Restricted Stock Awards Certain employees, directors and consultants have been awarded restricted stock. The restricted stock vesting consists of milestone and time-based vesting. The following table summarizes restricted stock award activity for the years ended December 31, 2023 and 2022: Weighted Average Grant Date Fair Number of Shares Value Nonvested at December 31, 2021 451,266 $ 33.48 Granted 159,416 20.00 Forfeited (15,850) 30.19 Vested (215,935) 36.63 Nonvested at December 31, 2022 378,897 $ 26.15 Granted 1,103,698 2.33 Forfeited (55,100) 11.34 Vested (111,375) 25.07 Non-vested at December 31, 2023 1,316,120 $ 6.88 As of December 31, 2023, there was $2.4 million of total unrecognized compensation cost related to non-vested restricted stock, which is expected to be recognized over a weighted-average period of 1.9 years. This amount does not include, as of December 31, 2023, 186,733 shares of restricted stock outstanding which are performance-based and vest upon achievement of certain corporate milestones. The expense is recognized over the vesting period of the award. Stock-based compensation for milestone awards will be measured and recorded if and when it is probable that the milestone will be achieved. Restricted Stock Units Certain employees have been awarded restricted stock units. The following table summarizes restricted stock units activity for the years ended December 31, 2023 and 2022: Weighted Average Number of Grant Date Fair Shares Value Non-vested at December 31, 2021 — $ — Granted 85,000 10.50 Non-vested at December 31, 2022 85,000 10.50 Granted 577,384 2.25 Forfeited (4,000) 10.50 Vested (42,500) 10.50 Non-vested at December 31, 2023 615,884 $ 2.77 As of December 31, 2023, all restricted stock units outstanding are performance-based and vest upon achievement of certain corporate milestones. The expense for milestone awards will be measured and recorded if and when it is probable that the milestone will be achieved. Stock Options The following table summarizes stock option award activity for the years ended December 31, 2023 and 2022: Weighted Average Remaining Weighted Average Contractual Life Stock Options Exercise Price (in years) Outstanding as of December 31, 2021 27,000 $ 31.35 7.44 Granted 4,000 14.20 Forfeited (4,000) 14.20 Outstanding as of December 31, 2022 27,000 $ 31.35 6.44 Granted 100,000 2.81 Outstanding as of December 31, 2023 127,000 $ 8.88 8.60 Vested and exercisable as of December 31, 2023 19,500 $ 24.68 6.04 Upon the exercise of stock options, the Company will issue new shares of its common stock. The Company used the Black-Scholes Model for determining the estimated fair value of stock-based compensation related to stock options. The table below summarizes the assumptions used: For the Years Ended December 31, 2023 2022 Risk-free interest rate 3.7 % 2.9 % Expected dividend yield — — Expected term in years 10.0 10.0 Expected volatility 83.5 % 73.1 % Warrants A summary of warrant activities for years ended December 31, 2023 and 2022 is presented below: Weighted Average Remaining Weighted Average Contractual Life Warrants Exercise Price (in years) Outstanding as of December 31, 2021 1,249 $ — 3.83 Granted 4,356,361 3.37 Fractional share adjustment (13) — Outstanding as of December 31, 2022 4,357,597 $ 3.37 3.26 Granted 35,513,575 2.30 Exercised (9,773,501) 1.76 Outstanding as of December 31, 2023 30,097,671 $ 2.36 3.00 Upon the exercise of warrants, the Company will issue new shares of its common stock. Stock-Based Compensation The following table summarizes stock-based compensation expense for the years ended December 31, 2023 and 2022 (in thousands). For the year ended December 31, 2023 2022 Research and development $ 1,169 $ 888 General and administrative 1,728 2,036 Total stock-based compensation expense $ 2,897 $ 2,924 |
Common Stock Warrant Liabilitie
Common Stock Warrant Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Common Stock Warrant Liabilities | |
Common Stock Warrant Liabilities | Note 7 – Common Stock Warrant Liabilities The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity Derivatives and Hedging – Contracts in Entity’s Own Equity On December 16, 2022, the Company closed on an offering for the sale of shares of its common stock and pre-funded warrants as part of the December 2022 Registered Direct Offering. The common stock and the pre-funded warrants were sold together with December 2022 Common Stock Warrants. The Company also issued the placement agent warrants to purchase shares (See Note 6). The Company deemed the December 2022 Common Stock Warrants and December 2022 Placement Agent Warrants to be classified as liabilities on the balance sheet as they contain terms for redemption of the underlying security that are outside its control. The December 2022 Common Warrants and December 2022 Placement Agent Warrants were recorded at the time of closing at a fair value, determined by using the Black-Scholes Model. As the total fair value of the common stock warrant liability exceeded the total proceeds, no proceeds were allocated to the common stock and pre-funded warrants issued as part of the transaction. The Company revalued the December 2022 Common Stock Warrants and December 2022 Placement Agent Warrants at December 31, 2022, resulting in a fair value of $11.2 million. The Company also revalued the December 2022 Common Stock Warrants and December 2022 Placement Agent Warrants at each reporting period in 2023, resulting in gains throughout the year. In October 2023, the Company entered into the October 2023 Inducement with a holder of certain of its existing warrants to exercise for cash an aggregate of 6,325,354 shares of the Company’s common stock at a reduced exercise price of $1.76 per share (see Note 6). Included in the exercise were the entirety of the December 2022 Common Stock Warrants. The Company revalued the December 2022 Common Stock Warrants on October 4, 2023, resulting in a fair value of $3.1 million. The decrease in the fair value of the common stock warrant liability throughout the year resulted in an offsetting gain on common stock warrant liabilities in the Statements of Operations. Since the December 2022 Placement Agent Warrants issued in the December 2022 Registered Direct Offering were not included in the October 2023 Inducement and have not been exercised, they were revalued at December 31, 2023. Warrant Liabilities Common Stock Warrant liabilities at December 31, 2021 $ — Issuance of December 2022 Common Stock Warrants 7,640 Issuance of December 2022 Placement Agent Warrants 278 Change in fair value of Common Stock Warrant liabilities 3,252 Common Stock Warrant liabilities at December 31, 2022 $ 11,170 Change in fair value of Common Stock Warrant liabilities (7,924) Exercise of December 2022 Common Stock Warrants (3,121) Common Stock Warrant liabilities at December 31, 2023 $ 125 The Company used the Black-Scholes Model for determining the estimated fair value of the common stock warrant liabilities, including as part of the October 2023 Inducement. A summary of the weighted average (in aggregate) significant unobservable inputs used in measuring the warrant liability is determined using Level 3 inputs as follows: October 4, December 31, Series A Warrants 2023 2022 Exercise price $ 1.76 $ 4.08 Volatility 91.4 % 89.4 % Expected life 4.2 5.0 Risk-free rate 4.7 % 4.0 % Dividend yield — — October 4, December 31, Series B Warrants 2023 2022 Exercise price $ 1.76 $ 4.08 Volatility 99.6 % 82.4 % Expected life 0.7 1.5 Risk-free rate 5.4 % 4.7 % Dividend yield — — December 31, December 31, Placement Agent Warrants 2023 2022 Exercise price $ 5.41 $ 5.41 Volatility 96.4 % 89.4 % Expected life 4.0 5.0 Risk-free rate 3.8 % 4.0 % Dividend yield — — |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes | |
Income Taxes | Note 8 - Income Taxes The Company has accumulated net losses since inception and has not recorded an income tax provision or benefit during the years ended December 31, 2023 and 2022. A reconciliation of the statutory U.S. federal rate to the Company’s effective tax rate is as follows: For the Year Ended December 31, 2023 2022 Percentage of pre-tax income: Statutory federal income tax rate 21 % 21 % State taxes, net of federal tax benefit 11 % 4 % Credits 2 % 3 % Change in state tax rate 12 % (4) % Provision to return — % — % Stock based compensation (1) % — % Change in fair market value of warrant — % — % Other (1) % (3) % Change in valuation allowance (43) % (21) % Income taxes provision (benefit) — % — % The components of the net deferred tax asset as of December 31, 2023 and 2022 are the following (in thousands): As of December 31, 2023 2022 Deferred tax assets: Net operating loss carryovers $ 45,000 $ 40,456 Stock compensation and other 1,384 1,066 Amortization of license 11,126 7,952 Accruals and reserves 825 463 Tax credits 5,105 4,112 Start Up Costs 24 21 Section 174 Capitalization 23,793 10,671 Total deferred tax assets 87,257 64,741 Less valuation allowance (87,257) (64,741) Deferred tax asset, net of valuation allowance $ — $ — The Company has determined, based upon available evidence, that it is more likely than not that the net deferred tax asset will not be realized and, accordingly, has provided a full valuation allowance against its net deferred tax asset. A valuation allowance of approximately $87.3 million and $64.7 million was recorded for the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023, the Company had federal and state net operating loss carryforwards of approximately $166.8 million and $154.2 million, respectively. Approximately $135.6 million of the federal net operating loss carryforwards and $1.7 million of the state net operating loss carryforwards can be carried forward indefinitely. The remaining $31.2 million of federal and $152.5 million of state net operating loss carryforwards will begin to expire, if not utilized, by 2034 and 2034, respectively. The Company has $3.7 million of research and development credit carryforwards and $1.4 million of orphan drug credit carryforwards, which will begin to expire, if not utilized, by 2034 There are no significant matters determined to be unrecognized tax benefits taken or expected to be taken in a tax return, in accordance with ASC 740, which clarifies the accounting for uncertainty in income taxes recognized in the financial statements, that have been recorded on the Company’s financial statements for the years ended December 31, 2023 and 2022. The Company does not anticipate a material change to unrecognized tax benefits in the next twelve months. Additionally, ASC 740 provides guidance on the recognition of interest and penalties related to income taxes. There were no interest or penalties related to income taxes that have been accrued or recognized as of and for the period ended December 31, 2023 and 2022. The Company would classify interest and penalties related to uncertain tax positions as income tax expense, if applicable. The federal and state tax returns for the periods ended December 31, 2020, 2021 and 2022 are currently open for examination under the applicable federal and state income tax statues of limitations. Beginning with the 2022 tax year, the Company is required to capitalize research and development expenses for tax purposes as defined under Internal Revenue Code Section 174. For expenses that are incurred for research and development in the U.S., the amounts will be amortized over 5 years, and for expenses that are incurred for research and development outside the U.S., the amounts will be amortized over 15 years. |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 12 Months Ended |
Dec. 31, 2023 | |
Accounts Payable and Accrued Expenses | |
Accounts Payable and Accrued Expenses | Note 9 - Accounts Payable and Accrued Expenses At December 31, 2023 and 2022, accounts payable and accrued expenses consisted of the following (in thousands): December 31, 2023 2022 Accounts payable $ 6,570 $ 11,535 Accrued compensation 1,206 1,195 Research and development 7,123 7,289 Other 586 278 Total accounts payable and accrued expenses $ 15,485 $ 20,297 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events | |
Subsequent Events | Note 10 – Subsequent Events In January 2024, the Company closed on a registered direct offering (the “January 2024 Registered Direct Offering”) for the issuance and sale of an aggregate of 1,275,000 shares of its common stock at a purchase price of $1.805 per share of common stock. In addition, the offering includes 6,481,233 shares of common stock in the form of pre-funded warrants at a price of $1.8049. The pre-funded warrants were funded in full at closing except for a nominal exercise price of $0.0001 and are exercisable commencing on the closing date and will terminate when such pre-funded warrants are exercised in full. In a concurrent private placement, Checkpoint issued and sold common warrants (the “January 2024 Common Warrants”) to purchase up to 7,756,233 shares of common stock. The January 2024 Common Warrants are exercisable immediately upon issuance with an exercise price of $1.68 per share and will expire five years following the issuance date. The Company also issued the placement agent warrants to purchase up to 465,374 shares of common stock with an exercise price of $2.2563 per share. The total gross proceeds from the January 2024 Registered Direct Offering were approximately $14.0 million with net proceeds of approximately $12.8 million after deducting approximately $1.2 million in commissions and other transaction costs. The shares of common stock and the shares underlying the pre-funded warrants were registered for sale under the March 2023 S-3. The Company will file a registration statement to register the January 2024 Common Stock Warrants and placement agent warrants. As of March 19 2024, 2,661,233 pre-funded warrants from the January 2024 Registered Direct Offering were fully exercised. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. The Company has no subsidiaries. |
Segments | Segments Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating and reporting |
Use of Estimates | Use of Estimates 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 expenses during the reporting period. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. |
Other Receivables - Related Party | Other Receivables - Related Party Other receivables consist of amounts due to the Company from TG Therapeutics, Inc. (“TGTX”), a related party, and are recorded at the invoiced amount. Effective September 30, 2023, the Company and TGTX agreed to mutually terminate the collaboration agreements. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. Upfront and milestone payments due to third parties that perform research and development services on the Company’s behalf will be expensed as services are rendered or when the milestone is achieved. Research and development costs primarily consist of personnel related expenses, including salaries, benefits, travel, and other related expenses, stock-based compensation, payments made to third parties for license and milestone costs related to in-licensed products and technology, payments made to third party contract research organizations for preclinical and clinical studies, investigative sites for clinical trials, consultants, the cost of acquiring and manufacturing clinical trial materials, costs associated with regulatory filings, laboratory costs and other supplies. In accordance with ASC 730-10-25-1, Research and Development |
Annual Equity Fee | Annual Equity Fee Under the Founders Agreement with Checkpoint dated March 17, 2015 and amended and restated in July 2016 and October 2017 (the “Founders Agreement”), Fortress is entitled to an annual equity fee on January 1 of each year equal to 2.5% of fully diluted outstanding equity of the Company, payable in Checkpoint common shares (“Annual Equity Fee”). The Annual Equity Fee was part of the consideration payable for formation of the Company, identification of certain assets, including the license contributed to Checkpoint by Fortress (see Note 4). The Company records the Annual Equity Fee in connection with the Founders Agreement with Fortress as contingent consideration. Contingent consideration is recorded when probable and reasonably estimable. Due to the nature of the Company’s assets and stage of development, future share prices and shares outstanding cannot be estimated prior to the issuance of the Annual Equity Fee. Due to these uncertainties, the Company has concluded that it is unable to reasonably estimate the contingent consideration until shares are actually issued on January 1 of each year. Pursuant to the Founders Agreement, the Company issued 368,907 shares of common stock to Fortress for the Annual Equity Fee, representing 2.5% of the fully diluted outstanding equity of Checkpoint on January 1, 2023. Because the number of outstanding shares issuable to Fortress was determinable on January 1, 2023 prior to the issuance of the December 31, 2022 financial statements, the Company recorded approximately $1.9 million in research and development expense and a credit to Common shares issuable - Founders Agreement during the year ended December 31, 2022. Pursuant to the Founders Agreement, the Company will issue 1,492,915 shares of common stock to Fortress for the Annual Equity Fee, representing 2.5% of the fully diluted outstanding equity of Checkpoint on January 1, 2024. The Company did not have enough unreserved authorized shares under its certificate of incorporation on January 1, 2024 to issue the shares for the Annual Equity Fee. Therefore, in December 2023, Fortress and Checkpoint mutually agreed to defer the issuance until such time as certificate of incorporation has been amended in order to increase the number of authorized that may be issued thereunder. Because the number of outstanding shares issuable to Fortress was determinable on January 1, 2024 prior to the issuance of the December 31, 2023 financial statements, the Company recorded approximately $3.4 million in research and development expense and a credit to Common shares issuable - Founders Agreement during the year ended December 31, 2023. |
Stock-Based Compensation Expenses | Stock-Based Compensation Expenses The Company expenses stock-based compensation over the requisite service period based on the estimated grant-date fair value of the awards and forfeiture rates. The Company accounts for forfeitures as they occur. The Company estimates the fair value of stock option grants using the Black-Scholes Model. The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. All stock-based compensation costs are recorded in general and administrative or research and development costs in the Statements of Operations based upon the underlying individual’s role at the Company. In addition, because some of the restricted stock, restricted stock units and options issued to employees, directors and consultants vest upon achievement of certain milestones, the total expense is uncertain. Compensation expense for such awards that vest upon the achievement of milestones is recognized when the achievement of such milestones is probable. |
Common Stock Warrant Liability | Common Stock Warrant Liability The Company has issued freestanding warrants to purchase shares of its common stock in connection with its financing activities and accounts for them in accordance with applicable accounting guidance as either liabilities or as equity instruments depending on the specific terms of the warrant agreements. Warrants classified as liabilities are remeasured each period they are outstanding. Any resulting gain or loss related to the change in the fair value of the warrant liability is recognized in gain (loss) on common stock warrant liabilities, a component of other income (loss), in the Statements of Operations. The Company estimates the fair value of common stock warrant liabilities using the Black-Scholes Model. The assumptions used in calculating the fair value represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. |
Fair Value Measurement | Fair Value Measurement The Company follows the accounting guidance in ASC 820 for its fair value measurements of financial assets and liabilities measured at fair value on a recurring basis. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. The accounting guidance requires fair value measurements be classified and disclosed in one of the following three categories: Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Observable inputs other than Level 1 prices, for similar assets or liabilities that are directly or indirectly observable in the marketplace. Level 3: Unobservable inputs which are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. Certain of the Company’s financial instruments are not measured at fair value on a recurring basis but are recorded at amounts that approximate their fair value due to their liquid or short-term nature, such as accounts payable and accrued expenses. |
Revenue from Contracts with Customers | Revenue from Contracts with Customers The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers ● Step 1: Identify the contract with the customer ● Step 2: Identify the performance obligations in the contract ● Step 3: Determine the transaction price ● Step 4: Allocate the transaction price to the performance obligations in the contract ● Step 5: Recognize revenue when the company satisfies a performance obligation In order to identify the performance obligations in a contract with a customer, a company must assess the promised goods or services in the contract and identify each promised good or service that is distinct. A performance obligation meets ASC 606’s definition of a “distinct” good or service (or bundle of goods or services) if both of the following criteria are met: ● the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (i.e., the good or service is capable of being distinct). ● the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (i.e., the promise to transfer the good or service is distinct within the context of the contract). If a good or service is not distinct, the good or service is combined with other promised goods or services until a bundle of goods or services is identified that is distinct. The transaction price is the amount of consideration to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. When determining the transaction price, an entity must consider the effects of all of the following: ● variable consideration; ● constraining estimates of variable consideration; ● the existence of a significant financing component in the contract; ● noncash consideration; and ● consideration payable to a customer Variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The transaction price is allocated to each performance obligation on a relative standalone selling price basis. The transaction price allocated to each performance obligation is recognized when that performance obligation is satisfied, at a point in time or over time as appropriate. Revenue for a sales-based or usage-based royalty promised in exchange for a license of intellectual property is recognized only when (or as) the later of the following events occurs: a. the subsequent sale or usage occurs; and b. the performance obligation to which some or all of the sales-based or usage-based royalty has been allocated has been satisfied (or partially satisfied). Incremental contract costs are expensed when incurred when the amortization period of the asset that would have been recognized is one year or less; otherwise, incremental contract costs are recognized as an asset and amortized over time as services are provided to a customer. |
Income Taxes | Income Taxes The Company records income taxes using the asset and liability method. Deferred income tax assets and liabilities are recognized for the future tax effects attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective income tax bases, and operating loss and tax credit carryforwards. The Company establishes a valuation allowance if management believes it is more likely than not that the deferred tax assets will not be recovered based on an evaluation of objective verifiable evidence. For tax positions that are more likely than not to be sustained upon audit, the Company recognizes the largest amount with a greater than 50% likely of being realized. The Company does not recognize any portion of the benefit for tax positions that are not more likely than not to be sustained upon audit. As of December 31, 2023 and December 31, 2022, the Company determined, based upon available evidence, that it is more likely than not that the net deferred tax asset will not be realized and, accordingly, has provided a full valuation allowance against its net deferred tax asset. |
Net Loss per Share | Net Loss per Share Net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Net loss attributable to common stockholders consisted of net loss, as adjusted for deemed dividends. The Company recorded a deemed dividend for the modification of certain of its existing warrants and issuance of the October 2023 Common Stock Warrants of $7.5 million during the year ended December 31, 2023 (see Notes 1 and 6). Diluted net loss per share does not reflect the effect of shares of common stock to be issued upon the exercise of stock options and warrants, as their inclusion would be anti-dilutive. The following table summarizes potentially dilutive securities outstanding at December 31, 2023 and 2022 that were excluded from the computation of diluted net loss per share, as they would be anti-dilutive: December 31, 2023 2022 Warrants (Note 6) 30,097,671 3,573,492 Stock options (Note 6) 127,000 27,000 Unvested restricted stock awards (Note 6) 1,316,120 378,897 Unvested restricted stock units (Note 6) 615,884 85,000 Total 32,156,675 4,064,389 The unexercised pre-funded warrants from the December 2022 Registered Direct Offering were included in the December 31, 2022 computation of diluted net loss per share since the exercise price was $0.0001. The 1,134,000 shares held in abeyance from the October 2023 Inducement (see Note 6) as of December 31, 2023 were included in the December 31, 2023 computation of diluted net loss per share since no additional consideration is due upon issuance of the shares. |
Comprehensive Loss | Comprehensive Loss The Company has no components of comprehensive loss other than net loss. Thus, comprehensive loss is the same as net loss for the periods presented. |
Recent Accounting Standards | Recent Accounting Standards In October 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) No. 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Updated and Simplification Initiative In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280) Improvements to Reportable Segment Disclosures Segment Reporting In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Significant Accounting Policies | |
Summary of potentially dilutive securities outstanding, that were excluded from the computation of diluted net loss per share, as they would be anti-dilutive | December 31, 2023 2022 Warrants (Note 6) 30,097,671 3,573,492 Stock options (Note 6) 127,000 27,000 Unvested restricted stock awards (Note 6) 1,316,120 378,897 Unvested restricted stock units (Note 6) 615,884 85,000 Total 32,156,675 4,064,389 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity | |
Summary of restricted stock award activity | Weighted Average Grant Date Fair Number of Shares Value Nonvested at December 31, 2021 451,266 $ 33.48 Granted 159,416 20.00 Forfeited (15,850) 30.19 Vested (215,935) 36.63 Nonvested at December 31, 2022 378,897 $ 26.15 Granted 1,103,698 2.33 Forfeited (55,100) 11.34 Vested (111,375) 25.07 Non-vested at December 31, 2023 1,316,120 $ 6.88 |
Summary of restricted stock units activity | Weighted Average Number of Grant Date Fair Shares Value Non-vested at December 31, 2021 — $ — Granted 85,000 10.50 Non-vested at December 31, 2022 85,000 10.50 Granted 577,384 2.25 Forfeited (4,000) 10.50 Vested (42,500) 10.50 Non-vested at December 31, 2023 615,884 $ 2.77 |
Summary of stock option award activity | Weighted Average Remaining Weighted Average Contractual Life Stock Options Exercise Price (in years) Outstanding as of December 31, 2021 27,000 $ 31.35 7.44 Granted 4,000 14.20 Forfeited (4,000) 14.20 Outstanding as of December 31, 2022 27,000 $ 31.35 6.44 Granted 100,000 2.81 Outstanding as of December 31, 2023 127,000 $ 8.88 8.60 Vested and exercisable as of December 31, 2023 19,500 $ 24.68 6.04 |
Summary of stock options assumptions used | For the Years Ended December 31, 2023 2022 Risk-free interest rate 3.7 % 2.9 % Expected dividend yield — — Expected term in years 10.0 10.0 Expected volatility 83.5 % 73.1 % |
Summary of warrant activities | Weighted Average Remaining Weighted Average Contractual Life Warrants Exercise Price (in years) Outstanding as of December 31, 2021 1,249 $ — 3.83 Granted 4,356,361 3.37 Fractional share adjustment (13) — Outstanding as of December 31, 2022 4,357,597 $ 3.37 3.26 Granted 35,513,575 2.30 Exercised (9,773,501) 1.76 Outstanding as of December 31, 2023 30,097,671 $ 2.36 3.00 |
Summary of stock-based compensation expense | The following table summarizes stock-based compensation expense for the years ended December 31, 2023 and 2022 (in thousands). For the year ended December 31, 2023 2022 Research and development $ 1,169 $ 888 General and administrative 1,728 2,036 Total stock-based compensation expense $ 2,897 $ 2,924 |
Common Stock Warrant Liabilit_2
Common Stock Warrant Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Common Stock Warrant Liabilities | |
Summary of common stock warrant liabilities | Warrant Liabilities Common Stock Warrant liabilities at December 31, 2021 $ — Issuance of December 2022 Common Stock Warrants 7,640 Issuance of December 2022 Placement Agent Warrants 278 Change in fair value of Common Stock Warrant liabilities 3,252 Common Stock Warrant liabilities at December 31, 2022 $ 11,170 Change in fair value of Common Stock Warrant liabilities (7,924) Exercise of December 2022 Common Stock Warrants (3,121) Common Stock Warrant liabilities at December 31, 2023 $ 125 |
Summary of the weighted average (in aggregate) significant unobservable inputs used in measuring the warrant liability that are categorized within Level 3 of the fair value hierarchy | October 4, December 31, Series A Warrants 2023 2022 Exercise price $ 1.76 $ 4.08 Volatility 91.4 % 89.4 % Expected life 4.2 5.0 Risk-free rate 4.7 % 4.0 % Dividend yield — — October 4, December 31, Series B Warrants 2023 2022 Exercise price $ 1.76 $ 4.08 Volatility 99.6 % 82.4 % Expected life 0.7 1.5 Risk-free rate 5.4 % 4.7 % Dividend yield — — December 31, December 31, Placement Agent Warrants 2023 2022 Exercise price $ 5.41 $ 5.41 Volatility 96.4 % 89.4 % Expected life 4.0 5.0 Risk-free rate 3.8 % 4.0 % Dividend yield — — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes | |
Schedule of effective income tax rate reconciliation | A reconciliation of the statutory U.S. federal rate to the Company’s effective tax rate is as follows: For the Year Ended December 31, 2023 2022 Percentage of pre-tax income: Statutory federal income tax rate 21 % 21 % State taxes, net of federal tax benefit 11 % 4 % Credits 2 % 3 % Change in state tax rate 12 % (4) % Provision to return — % — % Stock based compensation (1) % — % Change in fair market value of warrant — % — % Other (1) % (3) % Change in valuation allowance (43) % (21) % Income taxes provision (benefit) — % — % |
Schedule of deferred tax assets | The components of the net deferred tax asset as of December 31, 2023 and 2022 are the following (in thousands): As of December 31, 2023 2022 Deferred tax assets: Net operating loss carryovers $ 45,000 $ 40,456 Stock compensation and other 1,384 1,066 Amortization of license 11,126 7,952 Accruals and reserves 825 463 Tax credits 5,105 4,112 Start Up Costs 24 21 Section 174 Capitalization 23,793 10,671 Total deferred tax assets 87,257 64,741 Less valuation allowance (87,257) (64,741) Deferred tax asset, net of valuation allowance $ — $ — |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounts Payable and Accrued Expenses | |
Schedule of accounts payable and accrued expenses | At December 31, 2023 and 2022, accounts payable and accrued expenses consisted of the following (in thousands): December 31, 2023 2022 Accounts payable $ 6,570 $ 11,535 Accrued compensation 1,206 1,195 Research and development 7,123 7,289 Other 586 278 Total accounts payable and accrued expenses $ 15,485 $ 20,297 |
Organization and Description _2
Organization and Description of Business Operations (Details) | 1 Months Ended | 12 Months Ended | ||||||||||
Nov. 03, 2022 shares | Oct. 31, 2024 USD ($) | Oct. 31, 2023 USD ($) $ / shares shares | Jul. 31, 2023 USD ($) $ / shares shares | May 31, 2023 USD ($) $ / shares shares | Apr. 30, 2023 USD ($) $ / shares shares | Feb. 28, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2023 USD ($) shares | Dec. 31, 2022 USD ($) $ / shares shares | Nov. 30, 2023 shares | Nov. 02, 2022 shares | |
Organization and Description of Business Operations | ||||||||||||
Reverse stock split, conversion ratio | 0.1 | |||||||||||
Period after mailing of information statement to the common stockholders of record, that the reverse stock split will become effective | 20 days | |||||||||||
Accumulated deficit | $ | $ (262,486,000) | $ (314,333,000) | $ (262,486,000) | |||||||||
Purchase price per share | $ 5.25 | |||||||||||
Number of warrants issued | shares | 110,000 | |||||||||||
Class of warrants exercise price | $ 1.76 | $ 4.33249 | $ 4.33249 | |||||||||
Total gross proceeds from Issuance of common stock | $ | $ 7,500,000 | |||||||||||
Net proceeds from offering | $ | $ 6,700,000 | |||||||||||
Number of warrants issued and sold to purchase shares | shares | 1,134,000 | 6,215,354 | ||||||||||
Pre-Funded Warrants | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Number of shares issued and sold | shares | 950,000 | |||||||||||
Purchase price per share | 4.325 | $ 4.325 | ||||||||||
Class of warrants exercise price | $ 3.0899 | 0.0001 | 0.0001 | |||||||||
Series A Warrants | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Class of warrants exercise price | $ 4.075 | $ 4.075 | ||||||||||
Expiration term of warrants (in years) | 5 years | 5 years | ||||||||||
Number of warrants issued and sold to purchase shares | shares | 1,428,572 | 1,734,105 | 1,734,105 | |||||||||
Series B Warrants | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Class of warrants exercise price | $ 4.075 | $ 4.075 | ||||||||||
Expiration term of warrants (in years) | 18 months | 18 months | ||||||||||
Number of warrants issued and sold to purchase shares | shares | 1,734,105 | 1,734,105 | ||||||||||
At the market offering (ATM) | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Total gross proceeds from Issuance of common stock | $ | $ 0 | $ 10,120,000 | ||||||||||
Amount of commissions and other transaction costs | $ | $ 0 | $ 248,000 | ||||||||||
At the market offering (ATM) | Common Shares | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Purchase price per share | $ 18.99 | $ 18.99 | ||||||||||
December 2022 direct offering | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Number of shares issued and sold | shares | 950,000 | |||||||||||
Purchase price per share | $ 4.325 | 4.325 | ||||||||||
Class of warrants exercise price | 4.075 | |||||||||||
Total gross proceeds from Issuance of common stock | $ | $ 7,500,000 | |||||||||||
Net proceeds from offering | $ | 6,700,000 | |||||||||||
Amount of commissions and other transaction costs | $ | $ 800,000 | |||||||||||
December 2022 direct offering | Pre-Funded Warrants | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Number of warrants issued | shares | 784,105 | |||||||||||
Class of warrants exercise price | $ 4.3249 | 4.3249 | ||||||||||
December 2022 direct offering | Series A Warrants | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Class of warrants exercise price | $ 4.075 | $ 4.075 | ||||||||||
Expiration term of warrants (in years) | 5 years | 5 years | ||||||||||
December 2022 direct offering | Series A Warrants | Maximum | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Number of warrants issued and sold to purchase shares | shares | 1,734,105 | 1,734,105 | ||||||||||
December 2022 direct offering | Series B Warrants | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Class of warrants exercise price | $ 4.075 | $ 4.075 | ||||||||||
Expiration term of warrants (in years) | 18 months | 18 months | ||||||||||
December 2022 direct offering | Series B Warrants | Maximum | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Number of warrants issued and sold to purchase shares | shares | 1,734,105 | 1,734,105 | ||||||||||
February 2023 Registered Direct Offering | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Number of shares issued and sold | shares | 1,180,000 | |||||||||||
Purchase price per share | $ 5.25 | |||||||||||
Number of warrants issued | shares | 248,572 | |||||||||||
Class of warrants exercise price | 5 | |||||||||||
Total gross proceeds from Issuance of common stock | $ | $ 7,500,000 | |||||||||||
Net proceeds from offering | $ | 6,700,000 | |||||||||||
Amount of commissions and other transaction costs | $ | $ 800,000 | |||||||||||
February 2023 Registered Direct Offering | Pre-Funded Warrants | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Purchase price per share | $ 5.2499 | |||||||||||
Number of warrants issued | shares | 248,572 | |||||||||||
Class of warrants exercise price | $ 0.0001 | |||||||||||
Warrants, Offering Price | 5.2499 | |||||||||||
February 2023 Registered Direct Offering | Series A Warrants | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Class of warrants exercise price | $ 5 | |||||||||||
Expiration term of warrants (in years) | 5 years | |||||||||||
Number of warrants issued and sold to purchase shares | shares | 1,428,572 | |||||||||||
February 2023 Registered Direct Offering | Series B Warrants | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Class of warrants exercise price | $ 5 | |||||||||||
Expiration term of warrants (in years) | 18 months | |||||||||||
Number of warrants issued and sold to purchase shares | shares | 1,428,572 | |||||||||||
April 2023 Registered Direct Offering | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Number of shares issued and sold | shares | 1,700,000 | |||||||||||
Purchase price per share | $ 3.60 | |||||||||||
Total gross proceeds from Issuance of common stock | $ | $ 6,100,000 | |||||||||||
Net proceeds from offering | $ | 5,500,000 | |||||||||||
Amount of commissions and other transaction costs | $ | $ 600,000 | |||||||||||
April 2023 Registered Direct Offering | Series A Warrants | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Class of warrants exercise price | $ 3.35 | |||||||||||
Expiration term of warrants (in years) | 5 years | |||||||||||
Number of warrants issued and sold to purchase shares | shares | 1,700,000 | |||||||||||
April 2023 Registered Direct Offering | Series B Warrants | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Class of warrants exercise price | $ 3.35 | |||||||||||
Expiration term of warrants (in years) | 18 months | |||||||||||
Number of warrants issued and sold to purchase shares | shares | 1,700,000 | |||||||||||
May 2023 Registered Direct Offering | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Number of shares issued and sold | shares | 1,650,000 | |||||||||||
Purchase price per share | $ 3.071 | |||||||||||
Number of warrants issued | shares | 1,606,269 | |||||||||||
Class of warrants exercise price | $ 3.0709 | |||||||||||
Total gross proceeds from Issuance of common stock | $ | $ 10,000,000 | |||||||||||
Net proceeds from offering | $ | 9,100,000 | |||||||||||
Amount of commissions and other transaction costs | $ | $ 900,000 | |||||||||||
May 2023 Registered Direct Offering | Pre-Funded Warrants | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Number of warrants issued | shares | 1,606,269 | |||||||||||
Class of warrants exercise price | $ 0.0001 | |||||||||||
Warrants, Offering Price | 3.0709 | |||||||||||
May 2023 Registered Direct Offering | Series A Warrants | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Class of warrants exercise price | $ 2.821 | |||||||||||
Expiration term of warrants (in years) | 5 years | |||||||||||
May 2023 Registered Direct Offering | Series A Warrants | Maximum | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Number of warrants issued and sold to purchase shares | shares | 3,256,269 | |||||||||||
May 2023 Registered Direct Offering | Series B Warrants | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Class of warrants exercise price | $ 2.821 | |||||||||||
Expiration term of warrants (in years) | 18 months | |||||||||||
May 2023 Registered Direct Offering | Series B Warrants | Maximum | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Number of warrants issued and sold to purchase shares | shares | 3,256,269 | |||||||||||
July 2023 Registered Direct Offering | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Number of shares issued and sold | shares | 2,427,186 | |||||||||||
Purchase price per share | $ 3.09 | |||||||||||
Total gross proceeds from Issuance of common stock | $ | $ 10,000,000 | |||||||||||
Net proceeds from offering | $ | 9,100,000 | |||||||||||
Amount of commissions and other transaction costs | $ | $ 900,000 | |||||||||||
July 2023 Registered Direct Offering | Pre-Funded Warrants | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Number of warrants issued | shares | 809,062 | |||||||||||
Class of warrants exercise price | $ 0.0001 | |||||||||||
Warrants, Offering Price | $ 3.0899 | |||||||||||
Number of warrants issued and sold to purchase shares | shares | 809,062 | |||||||||||
July 2023 Registered Direct Offering | Series A Warrants | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Class of warrants exercise price | $ 2.84 | |||||||||||
Expiration term of warrants (in years) | 5 years | |||||||||||
July 2023 Registered Direct Offering | Series A Warrants | Maximum | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Number of warrants issued and sold to purchase shares | shares | 3,236,248 | |||||||||||
July 2023 Registered Direct Offering | Series B Warrants | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Class of warrants exercise price | $ 2.84 | |||||||||||
Expiration term of warrants (in years) | 18 months | |||||||||||
Number of warrants issued and sold to purchase shares | shares | 3,236,248 | |||||||||||
July 2023 Registered Direct Offering | Series B Warrants | Maximum | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Number of warrants issued and sold to purchase shares | shares | 3,236,248 | |||||||||||
July 2023 Registered Direct Offering | Common Shares | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Number of shares issued and sold | shares | 2,427,186 | |||||||||||
October 2023 Registered Direct Offering | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Class of warrants exercise price | $ 1.76 | $ 5 | $ 4.075 | $ 4.075 | ||||||||
Total gross proceeds from Issuance of common stock | $ | $ 11,100,000 | |||||||||||
Net proceeds from offering | $ | $ 10 | 10,000,000 | ||||||||||
Amount of commissions and other transaction costs | $ | $ 1,100,000 | |||||||||||
Number of warrants issued and sold to purchase shares | shares | 6,325,354 | 1,134,000 | ||||||||||
October 2023 Registered Direct Offering | Series A Warrants | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Class of warrants exercise price | $ 1.51 | |||||||||||
Expiration term of warrants (in years) | 5 years | |||||||||||
October 2023 Registered Direct Offering | Series A Warrants | Maximum | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Number of warrants issued and sold to purchase shares | shares | 6,325,354 | |||||||||||
October 2023 Registered Direct Offering | Series B Warrants | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Class of warrants exercise price | $ 1.51 | |||||||||||
Expiration term of warrants (in years) | 24 months | |||||||||||
Number of warrants issued and sold to purchase shares | shares | 6,325,354 | |||||||||||
October 2023 Registered Direct Offering | Series B Warrants | Maximum | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Number of warrants issued and sold to purchase shares | shares | 6,325,354 | |||||||||||
2015 Incentive Plan | ||||||||||||
Organization and Description of Business Operations | ||||||||||||
Number of shares available for issuance authorized | shares | 3,000,000 | 6,000,000 | 6,000,000 | 900,000 |
Significant Accounting Polici_4
Significant Accounting Policies (Details) $ in Millions | 12 Months Ended | ||||
Jan. 01, 2024 shares | Jan. 01, 2023 shares | Dec. 31, 2023 USD ($) segment shares | Dec. 31, 2022 USD ($) shares | Mar. 17, 2015 | |
Significant Accounting Policies | |||||
Number of operating segments | 1 | ||||
Number of reportable segments | 1 | ||||
Fortress Biotech, Inc | |||||
Significant Accounting Policies | |||||
Percentage of shares issued for offering and annual equity fee | 2.50% | 2.50% | 2.50% | ||
Number of shares issued and sold | shares | 1,492,915 | 368,907 | 398,660 | 56,671 | |
Research and development | |||||
Significant Accounting Policies | |||||
Value of common stock shares issued | $ | $ 3.4 | $ 1.9 |
Significant Accounting Polici_5
Significant Accounting Policies - Net Loss per Share (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |||||
Dec. 31, 2023 | Dec. 31, 2022 | Nov. 30, 2023 | Oct. 31, 2023 | Jul. 31, 2023 | Feb. 28, 2023 | |
Significant Accounting Policies | ||||||
Deemed dividends | $ 7.5 | $ 0 | ||||
Potentially dilutive securities that were excluded from the computation of diluted net loss per share, as they would be anti-dilutive | 32,156,675 | 4,064,389 | ||||
Class of warrants exercise price | $ 4.33249 | $ 1.76 | ||||
Number of warrants issued and sold to purchase shares | 1,134,000 | 6,215,354 | ||||
Pre-Funded Warrants | ||||||
Significant Accounting Policies | ||||||
Class of warrants exercise price | 0.0001 | $ 3.0899 | ||||
October 2023 Registered Direct Offering | ||||||
Significant Accounting Policies | ||||||
Class of warrants exercise price | $ 4.075 | $ 1.76 | $ 5 | |||
Number of warrants issued and sold to purchase shares | 1,134,000 | 6,325,354 | ||||
Warrants | ||||||
Significant Accounting Policies | ||||||
Potentially dilutive securities that were excluded from the computation of diluted net loss per share, as they would be anti-dilutive | 30,097,671 | 3,573,492 | ||||
Stock options | ||||||
Significant Accounting Policies | ||||||
Potentially dilutive securities that were excluded from the computation of diluted net loss per share, as they would be anti-dilutive | 127,000 | 27,000 | ||||
Unvested restricted stock | ||||||
Significant Accounting Policies | ||||||
Potentially dilutive securities that were excluded from the computation of diluted net loss per share, as they would be anti-dilutive | 1,316,120 | 378,897 | ||||
Unvested restricted stock units | ||||||
Significant Accounting Policies | ||||||
Potentially dilutive securities that were excluded from the computation of diluted net loss per share, as they would be anti-dilutive | 615,884 | 85,000 |
License Agreements (Details)
License Agreements (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2015 | May 11, 2015 | May 31, 2016 | Mar. 31, 2015 | Dec. 31, 2023 | Dec. 31, 2022 | Feb. 28, 2023 | Dec. 31, 2021 | Jan. 31, 2019 | |
License Agreements | |||||||||
Sale price per share | $ 5.25 | ||||||||
Research and development | |||||||||
License Agreements | |||||||||
Value of common stock shares issued | $ 3,400,000 | $ 1,900,000 | |||||||
NeuPharma, Inc. | |||||||||
License Agreements | |||||||||
Payment of upfront licensing fees | $ 1,000,000 | ||||||||
NeuPharma, Inc. | Additional sales milestone | |||||||||
License Agreements | |||||||||
Maximum potential milestone payments | 40,000,000 | ||||||||
NeuPharma, Inc. | Clinical and development milestone | |||||||||
License Agreements | |||||||||
Maximum potential milestone payments | 39,000,000 | ||||||||
NeuPharma, Inc. | Regulatory approvals to commercialize the products | |||||||||
License Agreements | |||||||||
Maximum potential milestone payments | 22,500,000 | ||||||||
Dana-Farber Cancer Institute | |||||||||
License Agreements | |||||||||
Payment of upfront licensing fees | $ 1,000,000 | ||||||||
Number of shares of common stock granted | 13,683 | 50,000 | |||||||
Value of common stock shares issued | $ 600,000 | $ 32,500 | |||||||
Sale price per share | $ 0.65 | ||||||||
Ownership percentage | 5% | ||||||||
Cash in exchange for common shares | $ 10,000,000 | ||||||||
Amount of milestone expensed | 5,000,000 | ||||||||
Maintenance fee | 50,000 | ||||||||
Dana-Farber Cancer Institute | First commercial sale milestone | |||||||||
License Agreements | |||||||||
Maximum potential milestone payments | 21,500,000 | ||||||||
Dana-Farber Cancer Institute | Additional sales milestone | |||||||||
License Agreements | |||||||||
Maximum potential milestone payments | $ 60,000,000 | ||||||||
Adimab, LLC | PD-L1 | Research and development | |||||||||
License Agreements | |||||||||
Non-Refundable milestone payment | $ 2,200,000 | ||||||||
Adimab, LLC | Regulatory approvals to commercialize the products | |||||||||
License Agreements | |||||||||
Maximum potential milestone payments | $ 2,500,000 | ||||||||
Jubilant Biosys Limited | |||||||||
License Agreements | |||||||||
Payment of upfront licensing fees | $ 2,000,000 | ||||||||
Jubilant Biosys Limited | Clinical and development milestone | |||||||||
License Agreements | |||||||||
Maximum potential milestone payments | 88,400,000 | ||||||||
Jubilant Biosys Limited | Regulatory approvals to commercialize the products | |||||||||
License Agreements | |||||||||
Maximum potential milestone payments | 59,500,000 | ||||||||
Jubilant Biosys Limited | Sale Millstone | |||||||||
License Agreements | |||||||||
Maximum potential milestone payments | $ 89,300,000 | ||||||||
Collaboration Agreement With TGTX | |||||||||
License Agreements | |||||||||
Revenue recognition milestone revenue recognized | $ 58,000 | $ 121,000 | |||||||
Collaborative Arrangement, Revenue Not from Contract with Customer, Statement of Income or Comprehensive Income [Extensible Enumeration] | Revenues | Revenues | |||||||
Sublicense Agreement with TGTX | |||||||||
License Agreements | |||||||||
Revenue recognition milestone revenue recognized | $ 46,000 | $ 70,000 |
Related Party Agreements (Detai
Related Party Agreements (Details) | 1 Months Ended | 12 Months Ended | ||
Mar. 17, 2015 USD ($) item | Dec. 31, 2016 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Fortress Biotech, Inc | Founders Agreement | ||||
Related Party Agreements | ||||
Issuance of common stock, percentage of outstanding diluted equity | 2.50% | |||
Number of business days | 5 days | |||
Voting equity, percentage of equity or debt financing | 2.50% | |||
Cash fee, percentage of annual net sales | 4.50% | |||
Cash fees, maximum number of days | 90 days | |||
Control fees, number of times | item | 5 | |||
Control fees, monthly net sales | 12 months | |||
Cash fee, percentage of monthly net sales | 4.50% | |||
Agreement term | 15 years | |||
Agreement renewal term | 1 year | |||
Fortress Biotech, Inc | Management Services Agreement | ||||
Related Party Agreements | ||||
Number of period | 5 years | |||
Annual consulting fee | $ 500,000 | |||
Increase in annual consulting fee | 1,000,000 | |||
Excess in net assets value | $ 100,000,000 | |||
Costs and expenses, related party | $ 500,000 | $ 500,000 | ||
Caribe Bioadvisors LLC | ||||
Related Party Agreements | ||||
Annual advisory service fee | $ 60,000 | |||
Costs and expenses, related party | 110,000 | 110,000 | ||
Caribe Bioadvisors LLC | Equity Incentive Grants | ||||
Related Party Agreements | ||||
Costs and expenses, related party | $ 50,000 | $ 50,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Commitments and Contingencies | ||
Litigation | $ 0 | $ 0 |
Stockholders' Equity - Restrict
Stockholders' Equity - Restricted Stock Awards (Details) - Restricted Stock - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Stockholders' Equity | ||
Non-vested beginning balance | 378,897 | 451,266 |
Number of Shares, Granted | 1,103,698 | 159,416 |
Number of Shares, Forfeited | (55,100) | (15,850) |
Number of Shares, Vested | (111,375) | (215,935) |
Non-vested ending balance | 1,316,120 | 378,897 |
Weighted Average Exercise Price, beginning balance | $ 26.15 | $ 33.48 |
Weighted Average Grant Date Fair Value, Granted | 2.33 | 20 |
Weighted Average Grant Date Fair Value, Forfeited | 11.34 | 30.19 |
Weighted Average Grant Date Fair Value, Vested | 25.07 | 36.63 |
Weighted Average Exercise Price , ending balance | $ 6.88 | $ 26.15 |
Stockholders' Equity - Restri_2
Stockholders' Equity - Restricted Stock Units (Details) - Unvested restricted stock units - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Number of Shares | ||
Non-vested beginning balance | 85,000 | |
Number of Shares, Granted | 577,384 | 85,000 |
Number of Shares, Forfeited | (4,000) | |
Number of Shares, Vested | (42,500) | |
Non-vested ending balance | 615,884 | 85,000 |
Weighted Average Grant Date Fair Value | ||
Weighted Average Exercise Price, beginning balance | $ 10.50 | |
Weighted Average Exercise Price Granted | 2.25 | $ 10.50 |
Weighted Average Grant Date Fair Value, Forfeited | 10.50 | |
Weighted Average Grant Date Fair Value, Vested | 10.50 | |
Weighted Average Exercise Price , ending balance | $ 2.77 | $ 10.50 |
Stockholders' Equity - Stock Op
Stockholders' Equity - Stock Options (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Stockholders' Equity | |||
Stock options, Forfeited | (4,000) | ||
Weighted Average Exercise Price , Forfeited | $ 14.20 | ||
Stock Options | |||
Stockholders' Equity | |||
Stock options, Outstanding (beginning) | 27,000 | 27,000 | |
Stock options, Granted | 100,000 | 4,000 | |
Stock options, Outstanding (ending) | 127,000 | 27,000 | 27,000 |
Vested and exercisable as of December 31, 2023 | 19,500 | ||
Weighted Average Exercise Price, Outstanding (beginning) | $ 31.35 | $ 31.35 | |
Weighted Average Exercise Price, Granted | 2.81 | 14.20 | |
Weighted Average Exercise Price, Outstanding (ending) | 8.88 | $ 31.35 | $ 31.35 |
Weighted Average Exercise Price, Vested and exercisable as of December 31, 2023 | $ 24.68 | ||
Weighted Average Remaining Contractual Life, Outstanding (in years) | 8 years 7 months 6 days | 6 years 5 months 8 days | 7 years 5 months 8 days |
Weighted Average Remaining Contractual Life, Vested and exercisable as of December 31, 2023 (in years) | 6 years 14 days |
Stockholders' Equity - Black-Sc
Stockholders' Equity - Black-Scholes Model (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Stockholders' Equity | ||
Risk-free interest rate | 3.70% | 2.90% |
Expected term in years | 10 years | 10 years |
Expected volatility | 83.50% | 73.10% |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants (Details) - Warrants - $ / shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Warrants, Outstanding beginning balance | 4,357,597 | 1,249 | |
Warrants, Granted | 35,513,575 | 4,356,361 | |
Warrants, Exercised | (9,773,501) | ||
Warrants, Fractional share adjustment | (13) | ||
Warrants, Outstanding ending balance | 30,097,671 | 4,357,597 | |
Warrants, Weighted Average Exercise Price, beginning balance | $ 3.37 | $ 0 | |
Weighted Average Exercise Price, Granted | 2.30 | 3.37 | |
Warrants, Weighted Average Exercise Price, Exercised | 1.76 | ||
Warrants, Weighted Average Exercise Price, ending balance | $ 2.36 | $ 3.37 | |
Warrants, Remaining contractual life | 3 years | 3 years 3 months 3 days | 3 years 9 months 29 days |
Stockholders' Equity - Stock-Ba
Stockholders' Equity - Stock-Based Compensation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Stockholders' Equity | ||
Total stock-based compensation expense | $ 2,897 | $ 2,924 |
Research and development | ||
Stockholders' Equity | ||
Total stock-based compensation expense | 1,169 | 888 |
General and administrative | ||
Stockholders' Equity | ||
Total stock-based compensation expense | $ 1,728 | $ 2,036 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) | 1 Months Ended | 12 Months Ended | |||||||||||||||
Jan. 01, 2024 shares | Oct. 04, 2023 USD ($) | Jan. 01, 2023 shares | Oct. 31, 2024 USD ($) | Oct. 31, 2023 USD ($) $ / shares shares | Jul. 31, 2023 USD ($) $ / shares shares | May 31, 2023 USD ($) $ / shares shares | Apr. 30, 2023 USD ($) $ / shares shares | Feb. 28, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2023 USD ($) multiplier Vote $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Nov. 30, 2023 shares | Mar. 31, 2023 USD ($) | Nov. 03, 2022 $ / shares shares | Nov. 02, 2022 shares | Nov. 30, 2020 USD ($) | |
Stockholders' Equity | |||||||||||||||||
Common stock, shares issued | 9,586,683 | 27,042,035 | 9,586,683 | ||||||||||||||
Common stock, shares authorized | 50,000,000 | 80,000,000 | 50,000,000 | 80,000,000 | 30,000,000 | ||||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||||||||
Common stock, shares outstanding | 9,586,683 | 27,042,035 | 9,586,683 | ||||||||||||||
Shelf registration statement, maximum authorized securities | $ | $ 100,000,000 | ||||||||||||||||
Purchase price per share | $ / shares | $ 5.25 | ||||||||||||||||
Net proceeds of common stock issued | $ | $ 9,872,000 | ||||||||||||||||
Issuance of common shares - Founders agreement | $ | $ 952,000 | 418,000 | |||||||||||||||
Proceeds from Warrant | $ | 11,134,000 | ||||||||||||||||
Payment of transactional costs for exercise of warrants | $ | 1,016,000 | ||||||||||||||||
Warrant inducement expense | $ | 1,200,000 | ||||||||||||||||
Loss on common stock warrant liabilities | $ | 217,000 | (4,451,000) | |||||||||||||||
Deemed dividends | $ | $ 7,500,000 | $ 0 | |||||||||||||||
Number of warrants issued | 110,000 | ||||||||||||||||
Number of warrants issued and sold to purchase shares | 1,134,000 | 6,215,354 | |||||||||||||||
Total unrecognized compensation cost related to non-vested | $ | $ 2,400,000 | ||||||||||||||||
Common stock shares issuable | 368,907 | 1,492,915 | 368,907 | ||||||||||||||
Class of warrants exercise price | $ / shares | $ 1.76 | $ 4.33249 | $ 4.33249 | ||||||||||||||
Total gross proceeds from Issuance of common stock | $ | $ 7,500,000 | ||||||||||||||||
Net proceeds from offering | $ | $ 6,700,000 | ||||||||||||||||
Pre-Funded Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Purchase price per share | $ / shares | 4.325 | $ 4.325 | |||||||||||||||
Number of shares issued and sold | 950,000 | ||||||||||||||||
Class of warrants exercise price | $ / shares | $ 3.0899 | $ 0.0001 | $ 0.0001 | ||||||||||||||
Series A Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 1,428,572 | 1,734,105 | 1,734,105 | ||||||||||||||
Class of warrants exercise price | $ / shares | $ 4.075 | $ 4.075 | |||||||||||||||
Expiration term of warrants (in years) | 5 years | 5 years | |||||||||||||||
Series B Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 1,734,105 | 1,734,105 | |||||||||||||||
Class of warrants exercise price | $ / shares | $ 4.075 | $ 4.075 | |||||||||||||||
Expiration term of warrants (in years) | 18 months | 18 months | |||||||||||||||
Placement Agent Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 104,046 | 104,046 | |||||||||||||||
Class of warrants exercise price | $ / shares | $ 5.406 | $ 5.406 | |||||||||||||||
Amount of commissions and other transaction costs | $ | $ 800,000 | ||||||||||||||||
Non-vested restricted stock | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Weighted average period (in years) | 1 year 10 months 24 days | ||||||||||||||||
Performance Shares | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Restricted stock outstanding non-vested | 186,733 | ||||||||||||||||
2015 Incentive Plan | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Common stock, shares authorized | 50,000,000 | 13,500,000 | |||||||||||||||
Number of shares available for issuance authorized | 6,000,000 | 6,000,000 | 3,000,000 | 900,000 | |||||||||||||
Plans expires (in years) | 10 years | ||||||||||||||||
Shares are available for issuance | 3,510,830 | ||||||||||||||||
At the market offering (ATM) | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Net proceeds of common stock issued | $ | $ 9,900,000 | ||||||||||||||||
Total gross proceeds from Issuance of common stock | $ | $ 0 | 10,120,000 | |||||||||||||||
Amount of commissions and other transaction costs | $ | $ 0 | $ 248,000 | |||||||||||||||
February 2023 Registered Direct Offering | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Purchase price per share | $ / shares | $ 5.25 | ||||||||||||||||
Number of warrants issued | 248,572 | ||||||||||||||||
Number of shares issued and sold | 1,180,000 | ||||||||||||||||
Class of warrants exercise price | $ / shares | 5 | ||||||||||||||||
Total gross proceeds from Issuance of common stock | $ | $ 7,500,000 | ||||||||||||||||
Net proceeds from offering | $ | 6,700,000 | ||||||||||||||||
Amount of commissions and other transaction costs | $ | $ 800,000 | ||||||||||||||||
February 2023 Registered Direct Offering | Pre-Funded Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Purchase price per share | $ / shares | $ 5.2499 | ||||||||||||||||
Number of warrants issued | 248,572 | ||||||||||||||||
Class of warrants exercise price | $ / shares | $ 0.0001 | ||||||||||||||||
Warrants offering price | $ / shares | $ 5.2499 | ||||||||||||||||
February 2023 Registered Direct Offering | Series A Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 1,428,572 | ||||||||||||||||
Class of warrants exercise price | $ / shares | $ 5 | ||||||||||||||||
Expiration term of warrants (in years) | 5 years | ||||||||||||||||
February 2023 Registered Direct Offering | Series B Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 1,428,572 | ||||||||||||||||
Class of warrants exercise price | $ / shares | $ 5 | ||||||||||||||||
Expiration term of warrants (in years) | 18 months | ||||||||||||||||
February 2023 Registered Direct Offering | Placement Agent Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 85,714 | ||||||||||||||||
Class of warrants exercise price | $ / shares | $ 6.5625 | ||||||||||||||||
April 2023 Direct Offering | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Purchase price per share | $ / shares | $ 3.60 | ||||||||||||||||
Shelf registration statement remaining authorized securities | $ | $ 150,000,000 | ||||||||||||||||
Number of shares issued and sold | 1,700,000 | ||||||||||||||||
Total gross proceeds from Issuance of common stock | $ | $ 6,100,000 | ||||||||||||||||
Net proceeds from offering | $ | 5,500,000 | ||||||||||||||||
Amount of commissions and other transaction costs | $ | $ 600,000 | ||||||||||||||||
April 2023 Direct Offering | Series A Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 1,700,000 | ||||||||||||||||
Class of warrants exercise price | $ / shares | $ 3.35 | ||||||||||||||||
Expiration term of warrants (in years) | 5 years | ||||||||||||||||
April 2023 Direct Offering | Series B Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 1,700,000 | ||||||||||||||||
Class of warrants exercise price | $ / shares | $ 3.35 | ||||||||||||||||
Expiration term of warrants (in years) | 18 months | ||||||||||||||||
April 2023 Direct Offering | Placement Agent Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 102,000 | ||||||||||||||||
Class of warrants exercise price | $ / shares | $ 4.50 | ||||||||||||||||
December 2022 direct offering | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Purchase price per share | $ / shares | $ 4.325 | $ 4.325 | |||||||||||||||
Number of shares issued and sold | 950,000 | ||||||||||||||||
Class of warrants exercise price | $ / shares | $ 4.075 | ||||||||||||||||
Total gross proceeds from Issuance of common stock | $ | $ 7,500,000 | ||||||||||||||||
Net proceeds from offering | $ | 6,700,000 | ||||||||||||||||
Amount of commissions and other transaction costs | $ | $ 800,000 | ||||||||||||||||
December 2022 direct offering | Pre-Funded Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued | 784,105 | ||||||||||||||||
Class of warrants exercise price | $ / shares | $ 4.3249 | 4.3249 | |||||||||||||||
December 2022 direct offering | Series A Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Class of warrants exercise price | $ / shares | $ 4.075 | $ 4.075 | |||||||||||||||
Expiration term of warrants (in years) | 5 years | 5 years | |||||||||||||||
December 2022 direct offering | Series B Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Class of warrants exercise price | $ / shares | $ 4.075 | $ 4.075 | |||||||||||||||
Expiration term of warrants (in years) | 18 months | 18 months | |||||||||||||||
December 2022 direct offering | Maximum | Series A Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 1,734,105 | 1,734,105 | |||||||||||||||
December 2022 direct offering | Maximum | Series B Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 1,734,105 | 1,734,105 | |||||||||||||||
May 2023 Registered Direct Offering | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Purchase price per share | $ / shares | $ 3.071 | ||||||||||||||||
Number of warrants issued | 1,606,269 | ||||||||||||||||
Number of shares issued and sold | 1,650,000 | ||||||||||||||||
Class of warrants exercise price | $ / shares | $ 3.0709 | ||||||||||||||||
Total gross proceeds from Issuance of common stock | $ | $ 10,000,000 | ||||||||||||||||
Net proceeds from offering | $ | 9,100,000 | ||||||||||||||||
Amount of commissions and other transaction costs | $ | $ 900,000 | ||||||||||||||||
May 2023 Registered Direct Offering | Pre-Funded Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued | 1,606,269 | ||||||||||||||||
Class of warrants exercise price | $ / shares | $ 0.0001 | ||||||||||||||||
Warrants offering price | $ / shares | 3.0709 | ||||||||||||||||
May 2023 Registered Direct Offering | Series A Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Class of warrants exercise price | $ / shares | $ 2.821 | ||||||||||||||||
Expiration term of warrants (in years) | 5 years | ||||||||||||||||
May 2023 Registered Direct Offering | Series B Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Class of warrants exercise price | $ / shares | $ 2.821 | ||||||||||||||||
Expiration term of warrants (in years) | 18 months | ||||||||||||||||
May 2023 Registered Direct Offering | Placement Agent Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 195,376 | ||||||||||||||||
Class of warrants exercise price | $ / shares | $ 3.8388 | ||||||||||||||||
May 2023 Registered Direct Offering | Maximum | Series A Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 3,256,269 | ||||||||||||||||
May 2023 Registered Direct Offering | Maximum | Series B Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 3,256,269 | ||||||||||||||||
July 2023 Registered Direct Offering | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Purchase price per share | $ / shares | $ 3.09 | ||||||||||||||||
Number of shares issued and sold | 2,427,186 | ||||||||||||||||
Total gross proceeds from Issuance of common stock | $ | $ 10,000,000 | ||||||||||||||||
Net proceeds from offering | $ | 9,100,000 | ||||||||||||||||
Amount of commissions and other transaction costs | $ | $ 900,000 | ||||||||||||||||
July 2023 Registered Direct Offering | Pre-Funded Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued | 809,062 | ||||||||||||||||
Number of warrants issued and sold to purchase shares | 809,062 | ||||||||||||||||
Class of warrants exercise price | $ / shares | $ 0.0001 | ||||||||||||||||
Warrants offering price | $ / shares | 3.0899 | ||||||||||||||||
July 2023 Registered Direct Offering | Series A Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Class of warrants exercise price | $ / shares | $ 2.84 | ||||||||||||||||
Expiration term of warrants (in years) | 5 years | ||||||||||||||||
July 2023 Registered Direct Offering | Series B Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 3,236,248 | ||||||||||||||||
Class of warrants exercise price | $ / shares | $ 2.84 | ||||||||||||||||
Expiration term of warrants (in years) | 18 months | ||||||||||||||||
July 2023 Registered Direct Offering | Placement Agent Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 194,175 | ||||||||||||||||
Class of warrants exercise price | $ / shares | $ 3.8625 | ||||||||||||||||
July 2023 Registered Direct Offering | Maximum | Series A Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 3,236,248 | ||||||||||||||||
July 2023 Registered Direct Offering | Maximum | Series B Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 3,236,248 | ||||||||||||||||
October 2023 Registered Direct Offering | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Proceeds from Warrant | $ | $ 11,100,000 | ||||||||||||||||
Payment of transactional costs for exercise of warrants | $ | $ 1,100,000 | ||||||||||||||||
Number of warrants issued and sold to purchase shares | 6,325,354 | 1,134,000 | |||||||||||||||
Class of warrants exercise price | $ / shares | $ 1.76 | $ 5 | $ 4.075 | $ 4.075 | |||||||||||||
Total gross proceeds from Issuance of common stock | $ | $ 11,100,000 | ||||||||||||||||
Net proceeds from offering | $ | $ 10 | 10,000,000 | |||||||||||||||
Amount of commissions and other transaction costs | $ | $ 1,100,000 | ||||||||||||||||
October 2023 Registered Direct Offering | Series A Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Class of warrants exercise price | $ / shares | $ 1.51 | ||||||||||||||||
Expiration term of warrants (in years) | 5 years | ||||||||||||||||
October 2023 Registered Direct Offering | Series B Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 6,325,354 | ||||||||||||||||
Class of warrants exercise price | $ / shares | $ 1.51 | ||||||||||||||||
Expiration term of warrants (in years) | 24 months | ||||||||||||||||
October 2023 Registered Direct Offering | Placement Agent Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 379,521 | ||||||||||||||||
Class of warrants exercise price | $ / shares | $ 2.20 | ||||||||||||||||
October 2023 Registered Direct Offering | Maximum | Series A Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 6,325,354 | ||||||||||||||||
October 2023 Registered Direct Offering | Maximum | Series B Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of warrants issued and sold to purchase shares | 6,325,354 | ||||||||||||||||
December 2022 Common Stock Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Loss on common stock warrant liabilities | $ | $ (7,700,000) | ||||||||||||||||
February 2023 Common Stock Warrants | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Warrant inducement expense | $ | $ 1,100,000 | ||||||||||||||||
Deemed dividends | $ | 6,300,000 | ||||||||||||||||
Fortress | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Issuance of common shares - Founders agreement | $ | 1,000,000 | $ 400,000 | |||||||||||||||
Shelf registration statement remaining authorized securities | $ | $ 91,700,000 | ||||||||||||||||
Percentage of annual equity fee | 2.50% | 2.50% | 2.50% | ||||||||||||||
Common stock shares issuable | 1,492,915 | ||||||||||||||||
Number of shares issued and sold | 1,492,915 | 368,907 | 398,660 | 56,671 | |||||||||||||
Agent | At the market offering (ATM) | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Commission rate | 3% | ||||||||||||||||
Common Stock | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of votes per share | Vote | 1 | ||||||||||||||||
Multiplier to calculate voting rights per class A common share | multiplier | 1.1 | ||||||||||||||||
Number of non assessable shares issued upon conversion | 1 | ||||||||||||||||
Common stock shares issued during the period under at the market offering | 532,816 | ||||||||||||||||
Common Stock | At the market offering (ATM) | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Common stock shares issued during the period under at the market offering | 532,816 | ||||||||||||||||
Aggregate gross proceeds of common stock issued | $ | $ 10,100,000 | ||||||||||||||||
Purchase price per share | $ / shares | $ 18.99 | $ 18.99 | |||||||||||||||
Common Stock | July 2023 Registered Direct Offering | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Number of shares issued and sold | 2,427,186 | ||||||||||||||||
Share price | $ / shares | $ 3.09 | ||||||||||||||||
Common Class A | |||||||||||||||||
Stockholders' Equity | |||||||||||||||||
Common stock, shares issued | 700,000 | 700,000 | 700,000 | ||||||||||||||
Common stock, shares authorized | 700,000 | ||||||||||||||||
Common stock, shares outstanding | 700,000 | 700,000 | 700,000 |
Common Stock Warrant Liabilit_3
Common Stock Warrant Liabilities - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||||
Dec. 16, 2022 | Dec. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2023 | Nov. 30, 2023 | Oct. 31, 2023 | Oct. 04, 2023 | |
Common Stock Warrant Liabilities | |||||||
Number of warrants issued and sold to purchase shares | 1,134,000 | 6,215,354 | |||||
Class of warrants exercise price | $ 4.33249 | $ 4.33249 | $ 1.76 | ||||
Net proceeds from offering | $ 6,700,000 | ||||||
December 2022 direct offering | |||||||
Common Stock Warrant Liabilities | |||||||
Class of warrants exercise price | $ 4.075 | ||||||
Net proceeds from offering | $ 6,700,000 | ||||||
December 2022 direct offering | Common Stock Warrant Liabilities | |||||||
Common Stock Warrant Liabilities | |||||||
Fair value of common stock warrants and placement agent warrants | $ 11,200,000 | $ 3,100,000 | |||||
Number of warrants issued and sold to purchase shares | 6,325,354 | ||||||
Class of warrants exercise price | $ 1.76 | ||||||
Net proceeds from offering | $ 0 |
Common Stock Warrant Liabilit_4
Common Stock Warrant Liabilities (Details) - December 2022 direct offering - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Common Stock Warrant Liabilities | ||
Common stock warrant liabilities | ||
Common Stock Warrant liabilities at the beginning | $ 11,170 | |
Change in fair value of warrant liabilities | (7,924) | $ 3,252 |
Common Stock Warrant liabilities at the end | 125 | 11,170 |
Common Stock Warrants | ||
Common stock warrant liabilities | ||
Issuance of warrants | 7,640 | |
Exercise of warrants | $ (3,121) | |
Placement Agent Warrants | ||
Common stock warrant liabilities | ||
Issuance of warrants | $ 278 |
Common Stock Warrant Liabilit_5
Common Stock Warrant Liabilities - Summary of the weighted average (in aggregate) significant unobservable inputs used in measuring the warrant liability that are categorized within Level 3 of the fair value hierarchy (Details) - Level 3 | Dec. 31, 2023 Y $ / shares | Oct. 04, 2023 Y $ / shares | Dec. 31, 2022 Y $ / shares |
Series A Warrants | Exercise price | |||
Common Stock Warrant Liabilities | |||
Measurement input | $ / shares | 1.76 | 4.08 | |
Series A Warrants | Volatility | |||
Common Stock Warrant Liabilities | |||
Measurement input | 0.914 | 0.894 | |
Series A Warrants | Expected life | |||
Common Stock Warrant Liabilities | |||
Measurement input | Y | 4.2 | 5 | |
Series A Warrants | Risk-free rate | |||
Common Stock Warrant Liabilities | |||
Measurement input | 0.047 | 0.040 | |
Series B Warrants | Exercise price | |||
Common Stock Warrant Liabilities | |||
Measurement input | $ / shares | 1.76 | 4.08 | |
Series B Warrants | Volatility | |||
Common Stock Warrant Liabilities | |||
Measurement input | 0.996 | 0.824 | |
Series B Warrants | Expected life | |||
Common Stock Warrant Liabilities | |||
Measurement input | Y | 0.7 | 1.5 | |
Series B Warrants | Risk-free rate | |||
Common Stock Warrant Liabilities | |||
Measurement input | 0.054 | 0.047 | |
Placement Agent Warrants | Exercise price | |||
Common Stock Warrant Liabilities | |||
Measurement input | $ / shares | 5.41 | 5.41 | |
Placement Agent Warrants | Volatility | |||
Common Stock Warrant Liabilities | |||
Measurement input | 0.964 | 0.894 | |
Placement Agent Warrants | Expected life | |||
Common Stock Warrant Liabilities | |||
Measurement input | Y | 4 | 5 | |
Placement Agent Warrants | Risk-free rate | |||
Common Stock Warrant Liabilities | |||
Measurement input | 0.038 | 0.040 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Statutory U.S. Federal Rate (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Percentage of pre-tax income: | ||
Statutory federal income tax rate | 21% | 21% |
State taxes, net of federal tax benefit | 11% | 4% |
Credits | 2% | 3% |
Change in state tax rate | 12% | (4.00%) |
Stock based compensation | (1.00%) | |
Other | (1.00%) | (3.00%) |
Change in valuation allowance | (43.00%) | (21.00%) |
Income taxes provision (benefit) | 0% | 0% |
Income Taxes - Components of Ne
Income Taxes - Components of Net Deferred Tax Asset (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating loss carryovers | $ 45,000 | $ 40,456 |
Stock compensation and other | 1,384 | 1,066 |
Amortization of license | 11,126 | 7,952 |
Accruals and reserves | 825 | 463 |
Tax credits | 5,105 | 4,112 |
Start Up Costs | 24 | 21 |
Section 174 Capitalization | 23,793 | 10,671 |
Total deferred tax assets | 87,257 | 64,741 |
Less valuation allowance | $ (87,257) | $ (64,741) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Less valuation allowance | $ 87,257 | $ 64,741 |
Tax credit Carryforward, Amount | 1,400 | |
Unrecognized tax benefits interest and penalties accrued | 0 | $ 0 |
Research and development credit carryforwards | ||
Tax credit Carryforward, Amount | $ 3,700 | |
Orphan drug credit carryforwards | ||
Tax credit carryforward, expiration date | Dec. 31, 2034 | |
Federal | ||
Operating Loss Carryforwards | $ 166,800 | |
Operating loss carryforwards indefinitely amount | 135,600 | |
Operating loss carryforwards remaining amount | $ 31,200 | |
Operating loss carry forwards expiration period | 2034 | |
State and Local | ||
Operating Loss Carryforwards | $ 154,200 | |
Operating loss carryforwards indefinitely amount | 1,700 | |
Operating loss carryforwards remaining amount | $ 152,500 | |
Operating loss carry forwards expiration period | 2034 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accounts Payable and Accrued Expenses | ||
Accounts payable | $ 6,570 | $ 11,535 |
Accrued compensation | 1,206 | 1,195 |
Research and development | 7,123 | 7,289 |
Other | 586 | 278 |
Total accounts payable and accrued expenses | $ 15,485 | $ 20,297 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | ||||||
Mar. 19, 2024 | Jan. 31, 2024 | Oct. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Nov. 30, 2023 | Jul. 31, 2023 | Feb. 28, 2023 | |
Subsequent Events | ||||||||
Purchase price per share | $ 5.25 | |||||||
Number of warrants issued | 110,000 | |||||||
Number of warrants issued and sold to purchase shares | 1,134,000 | 6,215,354 | ||||||
Class of warrants exercise price | $ 1.76 | $ 4.33249 | ||||||
Total gross proceeds from Issuance of common stock | $ 7.5 | |||||||
Net proceeds from offering | $ 6.7 | |||||||
Series A Warrants | ||||||||
Subsequent Events | ||||||||
Number of warrants issued and sold to purchase shares | 1,734,105 | 1,428,572 | ||||||
Class of warrants exercise price | $ 4.075 | |||||||
Expiration term of warrants (in years) | 5 years | |||||||
Series B Warrants | ||||||||
Subsequent Events | ||||||||
Number of warrants issued and sold to purchase shares | 1,734,105 | |||||||
Class of warrants exercise price | $ 4.075 | |||||||
Expiration term of warrants (in years) | 18 months | |||||||
Pre-Funded Warrants | ||||||||
Subsequent Events | ||||||||
Number of shares issued and sold | 950,000 | |||||||
Purchase price per share | $ 4.325 | |||||||
Class of warrants exercise price | $ 0.0001 | $ 3.0899 | ||||||
Number of shares issuable for each warrant | 784,105 | |||||||
Placement Agent Warrants | ||||||||
Subsequent Events | ||||||||
Number of warrants issued and sold to purchase shares | 104,046 | |||||||
Class of warrants exercise price | $ 5.406 | |||||||
Amount of commissions and other transaction costs | $ 0.8 | |||||||
Subsequent Event | January 2024 Registered Direct Offering | ||||||||
Subsequent Events | ||||||||
Number of shares issued and sold | 1,275,000 | |||||||
Purchase price per share | $ 1.805 | |||||||
Total gross proceeds from Issuance of common stock | $ 14 | |||||||
Amount of commissions and other transaction costs | $ 1.2 | |||||||
Subsequent Event | January 2024 Registered Direct Offering | Series B Warrants | ||||||||
Subsequent Events | ||||||||
Number of warrants issued and sold to purchase shares | 465,374 | |||||||
Class of warrants exercise price | $ 2.2563 | |||||||
Subsequent Event | January 2024 Registered Direct Offering | Pre-Funded Warrants | ||||||||
Subsequent Events | ||||||||
Class of warrants exercise price | $ 0.0001 | |||||||
Number of shares issuable for each warrant | 6,481,233 | |||||||
Warrants, Exercised | 2,661,233 | |||||||
Subsequent Event | January 2024 Registered Direct Offering | Placement Agent Warrants | ||||||||
Subsequent Events | ||||||||
Net proceeds from offering | $ 12.8 | |||||||
Subsequent Event | January 2024 Registered Direct Offering | Common Stock Warrants | ||||||||
Subsequent Events | ||||||||
Number of warrants issued and sold to purchase shares | 7,756,233 | |||||||
Class of warrants exercise price | $ 1.68 | |||||||
Subsequent Event | Maximum | January 2024 Registered Direct Offering | Series A Warrants | ||||||||
Subsequent Events | ||||||||
Class of warrants exercise price | $ 1.8049 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (51,847) | $ (62,624) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Rule 10b5-1 Arrangement Modified | false |
Non-Rule 10b5-1 Arrangement Modified | false |