CHECKPOINT THERAPEUTICS, INC.

CHECKPOINT THERAPEUTICS, INC._March 31, 2025

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark one)

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

For the quarterly period ended March 31, 2025

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

For the transition period from _________ to _________

Commission File Number 001-38128

CHECKPOINT THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware		47-2568632
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

95 Sawyer Road, Suite 110, Waltham, MA 02453

(Address of principal executive offices and zip code)

(781) 652-4500

(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 registered
Common Stock, par value $0.0001 per share		CKPT		NASDAQ Capital Market

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. YES ☒ 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). YES ☒ 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	☐
Non-accelerated Filer	☒	Smaller Reporting Company	☒
Emerging growth company	☐

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

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

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 May 9, 2025
Class A Common Stock, $0.0001 par value		700,000
Common Stock, $0.0001 par value		86,320,002

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CHECKPOINT THERAPEUTICS, INC.

Form 10-Q

For the Quarter Ended March 31, 2025

Table of Contents

		Page No.
PART I. FINANCIAL INFORMATION

Item 1.	Financial Statements	3

	Condensed Balance Sheets as of March 31, 2025 and December 31, 2024	3

	Condensed Statements of Operations for the three months ended March 31, 2025 and 2024	4

	Condensed Statements of Stockholders’ Equity (Deficit) for the three months ended March 31, 2025 and 2024	5

	Condensed Statements of Cash Flows for the three months ended March 31, 2025 and 2024	6

	Notes to Condensed Financial Statements	7

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	24

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	28

Item 4.	Controls and Procedures	28

PART II. OTHER INFORMATION

Item 1.	Legal Proceedings	29

Item 1A.	Risk Factors	29

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	60

Item 3.	Defaults Upon Senior Securities	60

Item 4.	Mine Safety Disclosures	60

Item 5.	Other Information	60

Item 6.	Exhibits	61

Signatures		62

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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 Drug Development, and the Commercialization of our FDA Approved Product UNLOXCYT™

●

Because results of preclinical studies and clinical trials are not necessarily predictive of future results, any product or 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.

●

Besides UNLOXCYT, 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 UNLOXCYT, a product or product candidate demonstrates lack of efficacy or adverse side effects, we may need to abandon or limit the development or commercialization of such product candidate.

●

We may not obtain the desired labeling claims or intended uses for product or UNLOXCYT promotion, or favorable scheduling classifications, to successfully promote our products or UNLOXCYT.

●

Even if a product candidate is approved, such as UNLOXCYT, it may be subject to various post-marketing requirements, including studies or clinical trials, and increased regulatory scrutiny.

●

Approval of UNLOXCYT or one of our product candidates in the United States does not assure approval of UNLOXCYT in foreign jurisdictions.

●

Our competitors have developed or may develop treatments for UNLOXCYT’s or our products’ target indications, which could limit UNLOXCYT’s or our product candidates’ commercial opportunity and profitability.

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If UNLOXCYT or 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 UNLOXCYT or 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 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 UNLOXCYT.

●

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 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.

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Our limited resources may cause us to fail to capitalize on programs, UNLOXCYT 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.

●

Tariffs and other trade measures could adversely affect our business, results of operations, financial position and cash flows.

Risks Related to the Merger, our Business Strategy, Structure and Organization

●

Our future growth and success depend on our ability to successfully develop and commercialize our product candidates and UNLOXCYT, either ourselves, or through a distributor or partner.

●

There is no assurance that the proposed Merger among us, Sun Pharmaceutical Industries, Inc. and Snoopy Merger Sub, Inc. will be completed in a timely manner or at all. The pendency and/or completion of the Merger could have an adverse effect on the trading price of our common stock and our business, financial condition, and prospects.

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●

Our future growth depends on our acquiring or in-licensing products or product candidates and integrating such products into our business.

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 for commercialization. If such third parties fail to perform contractual obligations, pass regulatory inspections, meet deadlines, comply with applicable regulations, or if our relationships with such third parties are disrupted, UNLOXCYT, or 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 Related 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.

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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 Related to Intellectual Property and Potential Disputes with Licensors Thereof

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If we are unable to obtain or 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, market and sell UNLOXCYT or potential products.

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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.

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Any dispute with our licensors may affect our ability to develop or commercialize UNLOXCYT or our product candidates.

Risks Related 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 Related 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.

Risks Related to Conflicts of Interest

●

We share certain directors with Fortress, which could create conflicts of interest between us and Fortress.

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Item 1. Financial Statements.

Checkpoint Therapeutics, Inc.

Condensed Balance Sheets

(in thousands, except share and per share amounts)

(Unaudited)


	March 31, 2025		December 31, 2024
ASSETS
Current Assets:
Cash and cash equivalents	$	33,042	$	6,604
Prepaid expenses and other current assets		1,122		867
Total current assets		34,164		7,471
Total Assets	$	34,164	$	7,471

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current Liabilities:
Accounts payable and accrued expenses	$	14,741	$	17,465
Accounts payable and accrued expenses - related party		2,868		2,433
Common stock warrant liabilities		260		198
Total current liabilities		17,869		20,096
Total Liabilities		17,869		20,096

Commitments and Contingencies (Note 5)

Stockholders’ Equity (Deficit)
Common Stock ($0.0001 par value), 175,000,000 shares authorized as of March 31, 2025 and December 31, 2024
Class A common shares, 700,000 shares issued and outstanding as of March 31, 2025 and December 31, 2024		—		—
Common shares, 83,063,733 and 53,640,422 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively		8		5
Common stock issuable, 0 and 2,386,808 shares as of March 31, 2025 and December 31, 2024, respectively		—		7,638
Additional paid-in capital		398,072		350,305
Accumulated deficit		(381,785)		(370,573)
Total Stockholders’ Equity (Deficit)		16,295		(12,625)
Total Liabilities and Stockholders’ Equity (Deficit)	$	34,164	$	7,471

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

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Checkpoint Therapeutics, Inc.

Condensed Statements of Operations

(in thousands, except share and per share amounts)

(Unaudited)


	For the three months ended March 31,
	2025		2024
Revenue - related party	$	—	$	—

Operating expenses:
Research and development		3,788		8,497
General and administrative		7,361

SEC Form 10-Q filed by Checkpoint Therapeutics Inc.