UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark one)
For the quarterly period ended
OR
For the transition period from _________ to _________
Commission File Number
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) |
| (I.R.S. Employer Identification No.) |
(Address of principal executive offices and zip code)
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(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
| Trading Symbol(s) |
| Name of each exchange on which |
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒ NO ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒ NO ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer | ☐ |
| Accelerated Filer | ☐ |
☒ |
| Smaller Reporting Company | ||
Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES
Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.
Class of Common Stock |
| Outstanding Shares as of November 8, 2024 |
Class A Common Stock, $0.0001 par value |
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Common Stock, $0.0001 par value |
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CHECKPOINT THERAPEUTICS, INC.
Form 10-Q
For the Quarter Ended September 30, 2024
Table of Contents
SUMMARY OF RISK FACTORS
Our business is subject to risks of which you should be aware before making an investment decision. The risks described below are a summary of the principal risks associated with an investment in us and are not the only risks we face. You should carefully consider these risk factors, the risk factors described in Item 1A, and the other reports and documents that we have filed with the Securities and Exchange Commission (“SEC”).
Risks Related to our Finances and Capital Requirements
● | We have incurred significant losses since our inception and anticipate that we will incur continued losses for the foreseeable future. We have not generated any sales revenue from our development stage products, and we do not know when, or if, we will generate any revenue from sales of an approved product. |
● | There is substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing. |
● | Our success is contingent upon raising additional capital for our development programs and potential commercialization efforts, which may fail. Even if successful, our future capital raising activities may dilute our current stockholders, restrict our operations, or require us to relinquish proprietary rights. |
● | Our limited resources may cause us to fail to capitalize on programs or product candidates presenting commercial opportunity or high likelihood of success. |
● | Weakness in the U.S. economy, including within our geographic footprint, has adversely affected us in the past and may adversely affect us in the future. |
Risks Pertaining to our Business Strategy, Structure and Organization
● | Our future growth and success depend on our ability to successfully develop and commercialize our product candidates, either by building an in-house commercial infrastructure or through a transaction with a commercial partner, which we have yet to do. |
● | Our future growth depends on our acquiring or in-licensing products or product candidates and integrating such products into our business. |
Risks Inherent in Drug Development and Commercialization
● | Because results of preclinical studies and early clinical trials are not necessarily predictive of future results, any product candidate we advance may not have favorable results in later clinical trials. Moreover, interim, “top-line,” and preliminary data from our clinical trials that we announce or publish may change, or the perceived product profile may be impacted, as more patient data or additional endpoints are analyzed. |
● | We may not receive the required regulatory approvals for any of our product candidates on our projected timelines, if at all, which may result in increased costs and delay our ability to generate revenue. |
● | If a product candidate demonstrates lack of efficacy or adverse side effects, we may need to abandon or limit the development of such product candidate. |
● | We may not obtain the desired labeling claims or intended uses for product promotion, or favorable scheduling classifications, to successfully promote our products. |
● | Even if a product candidate is approved, it may be subject to various post-marketing requirements, including studies or clinical trials, and increased regulatory scrutiny. |
● | Our competitors have developed or may develop treatments for our products’ target indications, which could limit our product candidates’ commercial opportunity and profitability. |
● | If our products are not broadly accepted by the healthcare community, the revenues from any such product will likely be limited. |
● | Any successful products liability claim related to any of our current or future product candidates may cause us to incur substantial liability and limit the commercialization of such products. |
Risks Related to Reliance on Third Parties
● | We rely, and will rely in the future, on third-party contract research organizations and contract manufacturers for the conduct of our preclinical and clinical studies and trials, for the completion of commercial and pre-commercial manufacturing and, eventually, for commercialization. If such third parties fail to perform contractual obligations, pass regulatory inspections or re-inspections, meet deadlines, comply with applicable regulations, or if our relationships with such third parties are disrupted, our product candidates may be delayed, and our revenue potential may be limited. |
● | We rely on clinical data and results obtained by third parties, which may prove inaccurate or unreliable. |
Risks Relating to Legislation and Regulation Affecting the Biopharmaceutical and Other Industries
● | We operate in a heavily regulated industry, and we cannot predict the impact that any future legislation or administrative or executive action may have on our operations. |
● | We may be subject to anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings. |
Risks Pertaining to Intellectual Property and Potential Disputes with Licensors Thereof
● | If we are unable to maintain sufficient patent protection for our technology and products, our competitors could develop and commercialize products similar or identical to ours, impairing our ability to successfully commercialize potential products. |
● | We or our licensors may be subject to costly and time-consuming litigation for infringement of third-party intellectual property rights or to enforce our or our licensors’ patents. |
● | Any dispute with our licensors may affect our ability to develop or commercialize our product candidates. |
Risks Relating to Our Platform and Data
● | Our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or third parties’ cybersecurity. |
Risks Relating to Our Control by Fortress Biotech, Inc. (“Fortress”)
● | Fortress controls a voting majority of our common stock and has the right to receive significant share grants annually, which will result in dilution of our other stockholders and could reduce the value of our common stock. |
● | We have entered into certain agreements with Fortress and may have received better terms from unaffiliated third parties. |
● | The interests of Fortress may not always coincide with the interests of other stockholders, and Fortress may take actions that advance its own interests and are contrary to the desires of our other stockholders. |
Risks Related to Conflicts of Interest
● | We share certain directors with Fortress, which could create conflicts of interest between us and Fortress. |
Item 1. Financial Statements.
Checkpoint Therapeutics, Inc.
Condensed Balance Sheets
(in thousands, except share and per share amounts)
(Unaudited)
| September 30, 2024 |
| December 31, 2023 | |||
ASSETS |
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Current Assets: |
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Cash and cash equivalents | $ | | $ | | ||
Prepaid expenses and other current assets |
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Total Assets | $ | | $ | | ||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current Liabilities: |
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Accounts payable and accrued expenses | $ | | $ | | ||
Accounts payable and accrued expenses - related party |
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Total current liabilities |
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Total Liabilities |
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Commitments and Contingencies (Note 5) |
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Stockholders’ Equity (Deficit) |
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Common Stock ($ |
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Class A common shares, |
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Common shares, |
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Common stock issuable, |
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Additional paid-in capital |
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Accumulated deficit |
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Total Stockholders’ Equity (Deficit) |
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Total Liabilities and Stockholders’ Equity (Deficit) | $ | | $ | |
The accompanying notes are an integral part of these condensed financial statements.
3
Checkpoint Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
For the three months ended September 30, | For the nine months ended September 30, | |||||||||||
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Revenue - related party | $ | — | $ | | $ | | $ | | ||||
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Operating expenses: |
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Loss from operations |
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Other income (expense) |
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Interest income |
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Gain on common stock warrant liabilities | — | | — | | ||||||||
Foreign currency exchange loss | ( | — | ( | — | ||||||||
Total other income (expense) |
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Net Loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
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Loss per Share: |
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Basic and diluted net loss per common share outstanding | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Basic and diluted weighted average number of common shares outstanding |
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The accompanying notes are an integral part of these condensed financial statements.
4
Checkpoint Therapeutics, Inc.
Condensed Statements of Stockholders’ Equity (Deficit)
(in thousands, except share amounts)
(Unaudited)
For the Three Months Ended September 30, 2024
Common | Additional | Total | ||||||||||||||||||||
Class A Common Shares | Common Shares | Stock | Paid-in | Accumulated | Stockholders’ | |||||||||||||||||
| Shares |
| Amount |
| Shares |
| Amount |
| Issuable |
| Capital |
| Deficit |
| Equity (Deficit) | |||||||
Balances at June 30, 2024 | | $ | — | | $ | | $ | — | $ | | $ | ( | $ | ( | ||||||||
Issuance of common shares, net of offering costs - Registered direct offering | — |
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Issuance of common shares - Founders Agreement | — | — | | — | — | | — | | ||||||||||||||
Stock-based compensation expense | — |
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Exercise of pre-funded and common stock warrants | — | — | | — | — | — | — | — | ||||||||||||||
Net loss | — |
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Balances at September 30, 2024 | |
| $ | — | | $ | | $ | — | $ | | $ | ( | $ | ( |
For the Nine Months Ended September 30, 2024
Common | Additional | Total | ||||||||||||||||||||
Class A Common Shares | Common Shares | Stock | Paid-in | Accumulated | Stockholders’ | |||||||||||||||||
| Shares |
| Amount |
| Shares |
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| Issuable |
| Capital |
| Deficit |
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Balances at December 31, 2023 | |
| $ | — | | $ | | $ | | $ | | $ | ( | $ | ( | |||||||
Issuance of common shares, net of offering costs - Registered direct offering | — | — | | | — | | — | | ||||||||||||||
Issuance of common shares - Founders Agreement | — |
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Stock-based compensation expense | — | — | | — | — | | — | | ||||||||||||||
Exercise of pre-funded and common stock warrants, including inducement | — | — | | — | — | — | — | — | ||||||||||||||
Net loss | — |
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Balances at September 30, 2024 | |
| $ | — | | $ | | $ | — | $ | | $ | ( | $ | ( |
5
For the Three Months Ended September 30, 2023
Common | Additional | Total | ||||||||||||||||||||
Class A Common Shares | Common Shares | Stock | Paid-in | Accumulated | Stockholders’ | |||||||||||||||||
| Shares |
| Amount |
| Shares |
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| Issuable |
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| Deficit |
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Balances at June 30, 2023 | |
| $ | — | | $ | | $ | — | $ | | $ | ( | $ | ( | |||||||
Issuance of common shares, net of offering costs - Registered direct offering | — | — | | — | — | | — | | ||||||||||||||
Issuance of common shares - Founders Agreement | — | — | | — | — | | — | | ||||||||||||||
Stock-based compensation expense | — |
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Exercise of pre-funded and common stock warrants | — |
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Net loss | — |
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Balances at September 30, 2023 | |
| $ | — | | $ | | $ | — | $ | | $ | ( | $ | ( |
For the Nine Months Ended September 30, 2023
Common | Additional | Total | ||||||||||||||||||||
Class A Common Shares | Common Shares | Stock | Paid-in | Accumulated | Stockholders’ | |||||||||||||||||
| Shares |
| Amount |
| Shares |
| Amount |
| Issuable |
| Capital |
| Deficit |
| Equity (Deficit) | |||||||
Balances at December 31, 2022 | |
| $ | — | | $ | | $ | | $ | | $ | ( | $ | ( | |||||||
Issuance of common shares, net of offering costs - Registered direct offering | — |
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Issuance of common shares - Founders Agreement | — | — | | — | ( | | — | | ||||||||||||||
Stock-based compensation expense | — |
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Exercise of pre-funded and common stock warrants | — | — | | — | — | — | — | — | ||||||||||||||
Net loss | — |
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Balances at September 30, 2023 | |
| $ | — | | $ | | $ | — | $ | | $ | ( | $ | ( |
The accompanying notes are an integral part of these condensed financial statements.
6
Checkpoint Therapeutics, Inc.
Condensed Statements of Cash Flows
(in thousands)
(Unaudited)
For the nine months ended September 30, | ||||||
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| 2023 | ||
Cash Flows from Operating Activities: |
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Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock-based compensation expense |
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Issuance of common shares - Founders Agreement |
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Gain on common stock warrant liabilities | — | ( | ||||
Changes in operating assets and liabilities: |
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Prepaid expenses and other current assets |
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Other receivables - related party |
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Accounts payable and accrued expenses |
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Accounts payable and accrued expenses - related party | ( | | ||||
Net cash used in operating activities |
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Cash Flows from Financing Activities: |
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Proceeds from issuance of common shares - Registered direct offerings | | | ||||
Payment of offering costs for the issuance of common shares - Registered direct offerings | ( | ( | ||||
Net cash provided by financing activities |
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Net decrease in cash and cash equivalents |
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Cash and cash equivalents at beginning of period |
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Cash and cash equivalents at end of period | $ | | $ | | ||
Supplemental disclosure of noncash investing and financing activities: |
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Issuance of common shares - Founders Agreement | $ | | $ | | ||
Unpaid offering costs for the issuance of common shares - Registered direct offerings | $ | | $ | |
The accompanying notes are an integral part of these condensed financial statements.
7
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.”
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 September 30, 2024, the Company had an accumulated deficit of $
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
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
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
8
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
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
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
In July 2024, the Company closed on a registered direct offering (the “July 2024 Registered Direct Offering”) for the issuance and sale of an aggregate of
On November 12, 2024, the Company received approximately $
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.
9
In accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern, the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the date that these financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that these consolidated financial statements are issued. In performing its analysis, management excluded certain elements of its operating plan that cannot be considered probable. Under ASC 205-40, the future receipt of potential funding from future equity or debt issuances and other potential sources such as partnerships cannot be considered probable at this time because these plans are not entirely within the Company’s control nor have these plans been approved by the Board of Directors as of the date of these financial statements.
The Company believes that its cash and cash equivalents are only sufficient to fund its operating expenses into the first quarter of 2025, assuming no exercises of outstanding common stock warrants. The Company has suffered recurring losses from operations and has a net capital deficiency that raises 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 that 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.
Note 2 - Significant Accounting Policies
Basis of Presentation
The accompanying unaudited interim condensed financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X of the Exchange Act. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. They may not include all of the information and notes required by GAAP for complete financial statements. Therefore, these condensed financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto for the year ended December 31, 2023, which were included in the Company’s Form 10-K and filed with the SEC on March 22, 2024. The results of operations for any interim periods are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period.
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.
10
Significant Accounting Policies
There have been no material changes in the Company’s significant accounting policies to those previously disclosed in the 2023 Annual Report on Form 10-K.
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.
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, costs incurred in obtaining technology licenses are charged to research and development expense if the technology licensed has not reached commercial feasibility and has no alternative future use. Such licenses purchased by the Company require substantial completion of research and development, regulatory and marketing approval efforts in order to reach commercial feasibility and have no alternative future use.
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
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
11
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 Condensed 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 (expense), in the Condensed 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.
12
Revenue from Contracts with Customers
The Company recognizes revenue under ASC 606, “Revenue from Contracts with Customers”. The core principle of the standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle:
● | 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); and |
● | 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.
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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% likelihood 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 September 30, 2024 and December 31, 2023, 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. 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 September 30, 2024 and 2023 that were excluded from the computation of diluted net loss per share, as they would be anti-dilutive:
September 30, | ||||
|
| 2024 |
| 2023 |
Warrants (Note 6) |
| | | |
Stock options (Note 6) |
| | | |
Unvested restricted stock awards (Note 6) | | | ||
Unvested restricted stock units (Note 6) |
| | | |
Total |
| | |
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.
Recently Issued Accounting Pronouncements
During the nine-month period ended September 30, 2024, there were no new accounting pronouncements or updates to recently issued accounting pronouncements as disclosed in the Company’s Form 10-K for the year ended December 31, 2023 that affect the Company’s present or future results of operations, overall financial condition, liquidity or disclosures.
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. Dana-Farber is eligible to receive payments of up to an aggregate of approximately $
In connection with the license agreement with Dana-Farber, the Company entered into a collaboration agreement with TGTX to develop and commercialize the anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies, while 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
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terminate the collaboration agreement. For the three months ended September 30, 2024 and 2023, the Company recognized
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 of up to an aggregate of approximately $
In February 2023 the Company expensed a non-refundable milestone payment of $
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. NeuPharma is eligible to receive additional payments of up to an aggregate of approximately $
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. Jubilant is eligible to receive payments up to an aggregate of approximately $
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 three and nine months ended September 30, 2023, the Company recognized approximately $
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.
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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 (
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 (
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 $
Note 5 – Commitments and Contingencies
Leases
The Company is not a party to any leases for office space or equipment.
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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. The Company expenses legal costs as they are incurred.
The Company and James Oliviero have been named as defendants in a consolidated putative stockholder class action lawsuit pending in the United States District Court for the Southern District of New York (the “Court”), which was filed on April 5, 2024. The action is styled In re Checkpoint Therapeutics, Inc. Securities Litigation, No. 1:24-cv-02613-PAE (the “Securities Class Action”). On June 21, 2024, the Court appointed a lead plaintiff for the putative class and approved his choice of lead counsel. The lead plaintiff filed his amended complaint (the “Amended Complaint”) on August 23, 2024, which alleges that defendants violated the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and SEC Rule 10b-5 promulgated thereunder by making false and misleading statements and omissions, and that James Oliviero is named as a control person under Section 20(a) of the Exchange Act. The Amended Complaint was filed on behalf of stockholders who purchased shares of the Company’s common stock between March 10, 2021, and December 15, 2023, and seeks, among other things, monetary damages on behalf of the purported class. Defendants moved to dismiss the Amended Complaint on October 23, 2024.
The Company has been named as a nominal defendant and certain of its current and former directors and executive officers have been named as defendants in a derivative lawsuit pending in the United States District Court for the Southern District of New York. The action is styled Geary v. Oliviero, et al., No. 1:24-cv-03471 (the “Derivative Action”). The Complaint in the Derivative Action, which was filed on May 6, 2024, asserts claims against all defendants under Delaware law for, among other things, breach of fiduciary duty, claims against all defendants under Section 14(a) of the Exchange Act, and claims for contribution under the federal securities laws against certain of the defendants. On June 20, 2024, the Derivative Action was stayed pending final resolution of the anticipated motion to dismiss in the Securities Class Action, including any appeals therefrom.
The Company believes that the allegations in the Securities Class Action and the Derivative Action are without merit and intends to defend itself and its directors and executive officers vigorously. There is no assurance, however, that the Company or the other defendants will be successful in their defense of either of these allegations or that the Company’s insurance policy coverage will be available or adequate to fund any settlement or judgment or the litigation costs of these actions. Moreover, the Company is unable to predict the outcome or reasonably estimate a range of possible losses at this time.
Note 6 – Stockholders’ Equity
Common Stock
At the Company’s 2024 Annual Meeting of Stockholders held on May 13, 2024, its stockholders approved an amendment to its certificate of incorporation to increase the number of authorized shares of common stock available to issue by
As of September 30, 2024 and December 31, 2023, there were
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Registered Direct Offerings
In November 2020, the Company filed a shelf registration statement on Form S-3 (the “November 2020 Form S-3”), which was declared effective in December 2020 (File No. 333-251005). Under the November 2020 Form S-3, the Company may sell up to a total of $
In February 2023, the Company closed on the February 2023 Registered Direct Offering for the issuance and sale of an aggregate of
In April 2023, the Company closed on the April 2023 Registered Direct Offering for the issuance and sale of an aggregate of
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 Form S-3”), which was declared effective May 5, 2023 (File No. 333-270843). Under the March 2023 Form S-3, the Company may sell up to a total of $
In May 2023, the Company closed on the May 2023 Registered Direct Offering for the issuance and sale of an aggregate of
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warrants from the May 2023 Registered Direct Offering were fully exercised. The May 2023 Common Stock Warrants and placement agent warrants met the criteria for equity classification.
In July 2023, the Company closed on the July 2023 Registered Direct Offering for the issuance and sale of an aggregate of
In January 2024, the Company closed on the January 2024 Registered Direct Offering for the issuance and sale of an aggregate of
In July 2024, the Company closed on the July 2024 Registered Direct Offering for the issuance and sale of an aggregate of
As of September 30, 2024, approximately $
The Company may offer the securities under the Form S-3’s 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.
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Warrant Inducement
In October 2023, the Company entered into the October 2023 Inducement with a certain holder of its existing warrants to exercise for cash an aggregate of
Upon the close of the transaction, the Company issued the holder
Shares Issued Under the Founders Agreement
Pursuant to the Founders Agreement, the Company issued
Pursuant to the Founders Agreement, the Company issued to Fortress
Pursuant to the Founders Agreement, the Company issued
Pursuant to the Founders Agreement, the Company issued to Fortress
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. At the Company’s 2024 Annual
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Meeting of Stockholders held on May 13, 2024, its stockholders approved an amendment to the 2015 Incentive Plan to increase the shares available for issuance to
On May 24, 2024, the Company filed a registration statement on Form S-8 under the Securities Act registering the common stock issued, issuable or reserved for issuance under our 2015 Incentive Plan. The registration statement became effective immediately upon filing, and shares covered by the registration statement are eligible for sale in the public markets, subject to grant of the underlying awards, vesting provisions and Rule 144 imitations applicable to our affiliates.
As of September 30, 2024,
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 nine months ended September 30, 2024:
Weighted Average | |||||
Number of | Grant Date Fair | ||||
| Shares |
| Value | ||
Non-vested at December 31, 2023 | | $ | | ||
Granted | | | |||
Forfeited | ( | | |||
Vested | ( | | |||
Non-vested at September 30, 2024 | | $ | |
As of September 30, 2024, there was $
Restricted Stock Units
The following table summarizes restricted stock units activity for the nine months ended September 30, 2024:
|
| Weighted Average | |||
Number of | Grant Date Fair | ||||
Shares | Value | ||||
Non-vested at December 31, 2023 |
| | $ | | |
Granted | | | |||
Forfeited | ( | | |||
Non-vested at September 30, 2024 |
| | $ | |
As of September 30, 2024, 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.
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Stock Options
The following table summarizes stock option award activity for the nine months ended September 30, 2024:
Weighted Average | |||||||
Remaining | |||||||
Weighted Average | Contractual Life | ||||||
| Stock Options |
| Exercise Price |
| (in years) | ||
Outstanding as of December 31, 2023 | | $ | | ||||
Outstanding as of September 30, 2024 | | $ | | ||||
Vested and exercisable as of September 30, 2024 | | $ | |
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.
Warrants
A summary of warrant activities for the nine months ended September 30, 2024 is presented below:
Weighted Average | |||||||
Remaining | |||||||
Weighted Average | Contractual Life | ||||||
| Warrants |
| Exercise Price |
| (in years) | ||
Outstanding as of December 31, 2023 | | $ | | ||||
Granted | |