Core Insights - Fortress Biotech is advancing its late-stage pipeline, with potential for up to three regulatory approvals in the next 12 months and a possible fourth BLA filing by 2025 [1][2] - The FDA has accepted the NDA for DFD-29, aimed at treating rosacea, with a PDUFA goal date set for November 4, 2024 [1][3] Financial Performance - Fortress reported a 7% year-over-year growth in product revenue for Q1 2024, driven by over 20% growth in flagship products Qbrexza® and Accutane® [2] - Consolidated net revenue for Q1 2024 was $13.0 million, compared to $12.4 million in Q1 2023, all from marketed dermatology products [7][11] - The consolidated net loss attributable to common stockholders for Q1 2024 was $(17.7) million, or $(1.03) per share, an improvement from a net loss of $(23.5) million, or $(3.47) per share in Q1 2023 [11][17] Regulatory Milestones - The NDA for DFD-29 was submitted in January 2024, with successful Phase 3 trials demonstrating statistical superiority over Oracea and placebo [3][4] - The company is also pursuing a rolling NDA for CUTX-101, expected to be completed in 2024, and plans to resubmit the BLA for cosibelimab by mid-2024 after addressing FDA feedback [3][4] Clinical Developments - The Phase 2 clinical trial for Triplex, a CMV vaccine for adults co-infected with HIV and CMV, is fully enrolled, with topline data expected in Q4 2024 [6] - A Phase 1b clinical trial for dotinurad, targeting gout and hyperuricemia, is ongoing, with data anticipated in mid-2024 [6] Corporate Highlights - Fortress raised approximately $11.0 million in a registered direct offering in January 2024, contributing to a consolidated cash position of $85.8 million as of March 31, 2024 [7][11] - Journey Medical, a partner company, reported total revenues of $13.0 million for Q1 2024, reflecting a 7% increase from the previous year [4]

[Summary of Risk Factors](index=3&type=section&id=Summary%20of%20Risk%20Factors) This section provides a high-level overview of the principal risks associated with an investment in Checkpoint Therapeutics, highlighting significant challenges across financial stability, drug development, regulatory environment, intellectual property, and its relationship with Fortress Biotech [Risks Related to our Finances and Capital Requirements](index=3&type=section&id=Risks%20Related%20to%20our%20Finances%20and%20Capital%20Requirements) The company has a history of significant losses and anticipates continued losses, raising substantial doubt about its ability to operate as a going concern, with future success contingent on raising additional capital that may be dilutive or restrictive - The company has incurred **significant losses** since inception and does not expect to be profitable in the foreseeable future[71](index=71&type=chunk) - There is **substantial doubt** about the company's ability to continue as a going concern, which may impede its ability to secure future financing[71](index=71&type=chunk) - Success depends on **raising additional capital**, which may **dilute current stockholders** or impose operational restrictions[71](index=71&type=chunk) [Risks Inherent in Drug Development and Commercialization](index=3&type=section&id=Risks%20Inherent%20in%20Drug%20Development%20and%20Commercialization) The company's growth is dependent on the successful development and commercialization of its product candidates, a process fraught with uncertainty where early positive trial results are not predictive of final outcomes and regulatory approval is not guaranteed - Future growth and success are **entirely dependent on the ability to successfully develop and commercialize product candidates**, which has not yet been achieved[75](index=75&type=chunk) - Early-stage clinical trial results are **not necessarily predictive of future outcomes**, and product candidates may **fail in later trials**[14](index=14&type=chunk) - **Competitors may develop superior treatments**, and products may **not be accepted by the healthcare community**, limiting revenue potential[14](index=14&type=chunk) [Risks Related to Reliance on Third Parties](index=4&type=section&id=Risks%20Related%20to%20Reliance%20on%20Third%20Parties) The company relies heavily on third-party contract research organizations (CROs) and manufacturers for preclinical studies, clinical trials, and manufacturing, where any failure by these third parties could significantly delay product development and commercialization - The company **depends on third-party CROs and manufacturers** for critical development and manufacturing activities, and **failure by these parties to perform, pass inspections, or meet deadlines could delay product candidates and limit revenue**[72](index=72&type=chunk) [Risks Relating to Legislation and Regulation Affecting the Biopharmaceutical and Other Industries](index=4&type=section&id=Risks%20Relating%20to%20Legislation%20and%20Regulation%20Affecting%20the%20Biopharmaceutical%20and%20Other%20Industries) Operating in a heavily regulated industry, the company faces risks from potential changes in healthcare laws and regulations, where compliance with anti-kickback, fraud, and other healthcare laws is critical to avoid criminal sanctions, civil penalties, and reputational harm - The company operates in a **heavily regulated industry** and **cannot predict the impact of future legislation or administrative actions** on its operations[6](index=6&type=chunk) - **Potential exposure to anti-kickback, fraud and abuse, and other healthcare laws** could lead to **criminal sanctions, civil penalties, and diminished profits**[6](index=6&type=chunk) [Risks Pertaining to Intellectual Property and Potential Disputes with Licensors Thereof](index=4&type=section&id=Risks%20Pertaining%20to%20Intellectual%20Property%20and%20Potential%20Disputes%20with%20Licensors%20Thereof) The company's ability to commercialize its products is dependent on maintaining sufficient patent protection, facing risks of costly litigation over intellectual property rights and potential disputes with its licensors that could affect product development - **Failure to maintain adequate patent protection** could allow competitors to develop similar products, **impairing commercialization efforts**[7](index=7&type=chunk) - The company or its licensors may face **costly and time-consuming litigation related to intellectual property infringement**[7](index=7&type=chunk) - **Disputes with licensors could negatively impact the development and commercialization** of product candidates[7](index=7&type=chunk) [Risks Relating to Our Control by Fortress Biotech, Inc. ("Fortress")](index=4&type=section&id=Risks%20Relating%20to%20Our%20Control%20by%20Fortress%20Biotech%2C%20Inc.%20%28Fortress%29) Fortress Biotech **controls a voting majority of the company's stock** and receives annual share grants, leading to dilution for other stockholders, with agreements potentially less favorable than those from unaffiliated parties and shared directors creating potential conflicts of interest - Fortress **controls a voting majority of common stock** and receives annual share grants, which **dilutes other stockholders** and could **reduce stock value**[8](index=8&type=chunk) - Agreements with Fortress may **not have been negotiated on arm's-length terms**, potentially being **less favorable** than deals with unaffiliated third parties[8](index=8&type=chunk) - The sharing of certain directors with Fortress could create **conflicts of interest** between the two companies[77](index=77&type=chunk) [PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed financial statements for the three months ended March 31, 2024, detail the company's financial position and performance, highlighting an increased cash position, reduced R&D expenses, continued net loss, and a substantial accumulated deficit, with notes emphasizing a going concern risk [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2024, the company's cash and cash equivalents increased to $11.2 million from $4.9 million at year-end 2023, driven by financing activities, with total assets growing to $12.0 million, total liabilities rising to $22.2 million, and a total stockholders' deficit of $10.3 million Condensed Balance Sheet Highlights (in thousands) | Metric | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $11,241 | $4,928 | | Total current assets | $11,975 | $5,378 | | **Total Assets** | **$11,975** | **$5,378** | | **Liabilities & Stockholders' Equity (Deficit)** | | | | Accounts payable and accrued expenses | $19,159 | $15,485 | | Total current liabilities | $22,225 | $18,425 | | **Total Liabilities** | **$22,225** | **$18,425** | | Accumulated deficit | $(325,278) | $(314,333) | | **Total Stockholders' Equity (Deficit)** | **$(10,250)** | **$(13,047)** | [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations) For the first quarter of 2024, the company reported a net loss of $10.9 million, compared to $10.5 million in the prior year, with research and development expenses significantly decreasing to $8.5 million from $15.8 million, while the 2023 period included a $7.6 million gain on common stock warrant liabilities Condensed Statement of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Revenue - related party | $— | $35 | | Research and development | $8,497 | $15,826 | | General and administrative | $2,451 | $2,292 | | **Loss from operations** | **$(10,948)** | **$(18,083)** | | Gain on common stock warrant liabilities | $— | $7,566 | | **Net Loss** | **$(10,945)** | **$(10,474)** | | **Basic and diluted net loss per share** | **$(0.33)** | **$(0.89)** | [Condensed Statements of Stockholders' Equity (Deficit)](index=7&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity%20%28Deficit%29) The stockholders' deficit improved from $13.0 million at the end of 2023 to $10.3 million at March 31, 2024, primarily driven by net proceeds from a registered direct offering, partially offset by the net loss for the quarter and stock-based compensation expenses Changes in Stockholders' Equity (Deficit) for Q1 2024 (in thousands) | Description | Amount | | :--- | :--- | | Balance at December 31, 2023 | $(13,047) | | Issuance of common shares, net of costs | $12,637 | | Issuance of common shares - Founders Agreement | $396 | | Stock-based compensation expense | $709 | | Net loss | $(10,945) | | **Balance at March 31, 2024** | **$(10,250)** | [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the first quarter of 2024, net cash used in operating activities was $6.5 million, a significant reduction from the prior year, with net cash provided by financing activities at $12.8 million, resulting in a net increase in cash and cash equivalents of $6.3 million, ending the quarter with $11.2 million Condensed Statement of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(6,474) | $(14,031) | | Net cash provided by financing activities | $12,787 | $6,809 | | **Net increase (decrease) in cash** | **$6,313** | **$(7,222)** | | Cash and cash equivalents at end of period | $11,241 | $4,846 | [Notes to Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes provide critical context, detailing the company's status as a clinical-stage entity with a significant accumulated deficit of **$325.3 million** and substantial doubt about its ability to continue as a going concern, with cash sufficient only into Q3 2024, and outlining financing activities and related-party agreements - The company has **substantial doubt about its ability to continue as a going concern**, as its **cash and cash equivalents are only sufficient to fund operating expenses into the third quarter of 2024**[59](index=59&type=chunk) - As of March 31, 2024, the company had an accumulated deficit of **$325.3 million**[46](index=46&type=chunk) - In January 2024, the company closed a registered direct offering with gross proceeds of approximately **$14.0 million**[58](index=58&type=chunk) - Under its Founders Agreement, the company owes its majority shareholder, Fortress, an annual equity fee of **2.5%** of its fully diluted equity, with the January 1, 2024 issuance deferred due to a lack of sufficient authorized shares[10](index=10&type=chunk)[193](index=193&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=37&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's status as a clinical-stage entity focused on its lead candidates, cosibelimab and olafertinib, highlighting the FDA's Complete Response Letter (CRL) for cosibelimab due to manufacturing issues, a $7.3 million decrease in Q1 2024 R&D expenses, and reiterating the critical liquidity situation with cash sufficient only into Q3 2024 - The FDA issued a **Complete Response Letter (CRL)** for the cosibelimab BLA in December 2023, citing findings at a third-party contract manufacturing organization, and Checkpoint intends to **resubmit the BLA**[219](index=219&type=chunk) Comparison of Operating Expenses (in millions) | Expense Category | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | Research & Development | $8.5 | $15.8 | $(7.3) | | General & Administrative | $2.5 | $2.3 | $0.2 | - The decrease in R&D expenses was primarily due to a reduction in manufacturing costs and the absence of prior period expenses, including a **$3.2 million** PDUFA fee and **$2.3 million** in license fees related to the BLA filing[242](index=242&type=chunk) - The company's **cash and cash equivalents are only sufficient to fund operations into the third quarter of 2024**, raising **substantial doubt about its ability to continue as a going concern**[278](index=278&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company is classified as a "smaller reporting company" under Exchange Act rules and is therefore not required to provide the information typically disclosed under this item - As a **smaller reporting company**, Checkpoint Therapeutics is **not required to provide quantitative and qualitative disclosures about market risk**[296](index=296&type=chunk) [Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the Chief Executive Officer and Chief Financial Officer, evaluated the company's disclosure controls and procedures and concluded they were effective as of March 31, 2024, with no material changes in internal control over financial reporting during the quarter - Based on an evaluation, the CEO and CFO concluded that the company's disclosure controls and procedures are **effective** as of the end of the period[119](index=119&type=chunk) - **No changes occurred** during the fiscal quarter ended March 31, 2024, that have materially affected, or are **not reasonably likely to materially affect**, the company's internal control over financial reporting[201](index=201&type=chunk) [PART II. OTHER INFORMATION](index=47&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=47&type=section&id=Item%201.%20Legal%20Proceedings) The company is currently facing two significant legal challenges: a consolidated putative stockholder class action lawsuit and a derivative lawsuit, with the company believing the allegations in both cases are without merit and planning to defend itself vigorously, though the outcome and potential financial impact are uncertain - The company and certain executive officers are defendants in a **consolidated stockholder class action lawsuit** (Moore v. Checkpoint Therapeutics, Inc.) alleging false and misleading statements between March 2021 and December 2023[115](index=115&type=chunk)[185](index=185&type=chunk) - A **derivative lawsuit** (Geary v. Oliviero, et al.) has been filed against certain current and former directors and officers, asserting claims for **breach of fiduciary duty** under Delaware law and violations of the Exchange Act[186](index=186&type=chunk)[195](index=195&type=chunk) - The company believes the allegations are **without merit** and intends to defend itself vigorously, but it is **unable to predict the outcome or estimate a range of possible losses** at this time[93](index=93&type=chunk)[187](index=187&type=chunk) [Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) This section details the numerous and significant risks facing the company, categorized into financial condition, business strategy, drug development uncertainties, reliance on third parties, regulatory landscape, intellectual property protection, data security, and its relationship with its controlling shareholder [Recent Sales of Unregistered Securities](index=104&type=section&id=Item%202.%20Recent%20Sales%20of%20Unregistered%20Securities) The company has not provided new information regarding recent sales of unregistered securities in this report, stating that such information has been previously disclosed in other SEC filings - **No new information is provided** under this item; the company refers to information previously included in its Annual Report on Form 10-K or in a Current Report on Form 8-K[399](index=399&type=chunk) [Exhibits](index=105&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed concurrently with the Form 10-Q, including the Amended and Restated Non-Employee Directors Compensation Plan, certifications from the Principal Executive Officer and Principal Financial Officer, and the company's financial statements formatted in XBRL - The report includes several exhibits, such as the **Amended and Restated Non-Employee Directors Compensation Plan**[403](index=403&type=chunk) - **Certifications by the Principal Executive Officer and Principal Financial Officer** pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 are filed as exhibits[518](index=518&type=chunk)

[Recent Corporate Updates](index=1&type=section&id=Recent%20Corporate%20Updates) Checkpoint Therapeutics received a CRL for cosibelimab BLA due to manufacturing issues, plans mid-2024 resubmission, and secured $14.0 million in financing - The FDA issued a CRL for the cosibelimab BLA in December 2023, citing only issues at a third-party contract manufacturing organization (CMO), with clinical data, safety, and labeling not being concerns, and Checkpoint plans to resubmit the BLA around **mid-year 2024**[1](index=1&type=chunk)[6](index=6&type=chunk) - In January 2024, Checkpoint secured approximately **$14.0 million** in gross proceeds through a registered direct offering and a concurrent private placement of warrants[1](index=1&type=chunk) - Dr. Amit Sharma, a life sciences executive from Alexion, AstraZeneca Rare Disease, was appointed as a non-executive director to the Board in March 2024[1](index=1&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) Checkpoint's Q1 2024 financial results show increased cash to $11.2 million, a 46% R&D expense reduction, and a net loss of $10.9 million Q1 2024 vs Q1 2023 Financial Highlights (in thousands) | Metric | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $11,241 | N/A | +$6,313 (vs Q4 2023) | | Research & Development Expenses | $8,497 | $15,826 | -$7,329 | | General & Administrative Expenses | $2,451 | $2,292 | +$159 | | Net Loss | $10,945 | $10,474 | +$471 | Q1 2024 vs Q1 2023 Per Share Data | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net Loss Per Share (Basic & Diluted) | $(0.33) | $(0.89) | | Weighted Average Shares Outstanding | 33,930,977 | 11,749,139 | [Financial Statements](index=4&type=section&id=Financial%20Statements) Unaudited condensed financial statements for Q1 2024 detail the company's financial position, showing increased cash and assets, and reduced R&D spending [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2024, Checkpoint's balance sheet shows total assets of $12.0 million, total liabilities of $22.2 million, and a stockholders' deficit of $10.3 million Condensed Balance Sheet Data (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $11,241 | $4,928 | | Total current assets | $11,975 | $5,378 | | **Total Assets** | **$11,975** | **$5,378** | | **Liabilities & Equity** | | | | Total current liabilities | $22,225 | $18,425 | | **Total Liabilities** | **$22,225** | **$18,425** | | **Total Stockholders' Deficit** | **($10,250)** | **($13,047)** | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) Q1 2024 statements of operations show no related-party revenue, a total operating loss of $10.9 million, and a net loss of ($0.33) per share Q1 Statement of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Revenue - related party | $- | $35 | | Research and development | $8,497 | $15,826 | | General and administrative | $2,451 | $2,292 | | **Total operating expenses** | **$10,948** | **$18,118** | | **Loss from operations** | **($10,948)** | **($18,083)** | | **Net Loss** | **($10,945)** | **($10,474)** | | **Net loss per common share** | **($0.33)** | **($0.89)** | [About Checkpoint Therapeutics](index=2&type=section&id=About%20Checkpoint%20Therapeutics) Checkpoint Therapeutics is a clinical-stage biopharmaceutical company developing novel treatments for solid tumor cancers, including cosibelimab and olafertinib - The company's lead antibody product is **cosibelimab**, a potential best-in-class anti-PD-L1 antibody being evaluated for recurrent or metastatic cancers[2](index=2&type=chunk) - The lead small-molecule agent is **olafertinib**, an EGFR inhibitor for patients with EGFR mutation-positive non-small cell lung cancer[2](index=2&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section outlines forward-looking statements regarding cosibelimab's approval and business projections, subject to regulatory, manufacturing, and financial risks - Statements regarding the ability to address CRL issues, the timeline for BLA resubmission, and the potential approval of cosibelimab are forward-looking[8](index=8&type=chunk) - Key risks include potential for final data to differ from interim results, regulatory rejection, manufacturing and supply chain issues, and the need for additional funding[8](index=8&type=chunk)

WALTHAM, Mass., May 10, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the first quarter ended March 31, 2024, and recent corporate updates. James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "Over the past few months, we have worked closely with our third-party contract manufacturing organization ("CMO") for cosibelimab to resolve their inspect ...

PART I [Business](index=7&type=section&id=Item%201.%20Business) Checkpoint Therapeutics, a clinical-stage oncology company, faces an FDA CRL for its lead product cosibelimab due to manufacturing issues - The company's lead product, cosibelimab, received a **Complete Response Letter (CRL)** from the FDA in **December 2023**. The CRL cited issues at a **third-party contract manufacturing organization**, not issues with the clinical data, and a resubmission is planned[428](index=428&type=chunk)[579](index=579&type=chunk) - As a development-stage company, Checkpoint has **not generated any revenue** from product sales and has a **significant accumulated deficit**[170](index=170&type=chunk)[580](index=580&type=chunk) Key Financials as of December 31, 2023 | Metric | Value (USD) | | :--- | :--- | | Accumulated Deficit | $314.3 million | [Products Under Development](index=9&type=section&id=PRODUCTS%20UNDER%20DEVELOPMENT) The pipeline is led by cosibelimab for CSCC, includes olafertinib and preclinical assets, with a terminated TG Therapeutics collaboration Cosibelimab Clinical Trial Results for CSCC | Indication | Patient Group | Confirmed Objective Response Rate (ORR) | | :--- | :--- | :--- | | Metastatic CSCC | 78 patients | 47.4% | | Locally Advanced CSCC | 31 patients | 54.8% | - **Olafertinib** (EGFR inhibitor) is being developed for metastatic NSCLC. The company plans to use data from an ongoing **Phase 3 trial** in China, conducted by its licensor NeuPharma, to support a U.S. NDA[61](index=61&type=chunk)[618](index=618&type=chunk) - The company's anti-GITR (CK-302), BET inhibitor (CK-103), and anti-CAIX programs are currently in **preclinical development**[59](index=59&type=chunk)[62](index=62&type=chunk)[63](index=63&type=chunk) - Collaboration agreements with TG Therapeutics for developing assets in hematological malignancies were **mutually terminated** on **September 30, 2023**, with all rights reverting to Checkpoint[21](index=21&type=chunk)[564](index=564&type=chunk)[584](index=584&type=chunk) [Intellectual Property and Patents](index=14&type=section&id=INTELLECTUAL%20PROPERTY%20AND%20PATENTS) Checkpoint's IP strategy relies on in-licensed and company-owned patents for key candidates, with expirations into the 2030s - The company in-licensed key intellectual property from Dana-Farber for its anti-PD-L1, anti-GITR, and anti-CAIX antibody programs. Patents related to the PD-L1 portfolio are scheduled to **expire between 2033 and 2040**[66](index=66&type=chunk)[592](index=592&type=chunk) - The patent estate for **olafertinib**, licensed from NeuPharma, includes granted U.S. and foreign patents with terms running to **August 2034**, with potential for later expirations up to **February 2039** for newer applications[35](index=35&type=chunk) - The company received **FDA Orphan Drug Designation** for **olafertinib** in **September 2017** for the treatment of EGFR mutation-positive NSCLC, which could provide a **seven-year period of marketing exclusivity** upon approval[69](index=69&type=chunk) [Licensing Agreements and Collaborations](index=19&type=section&id=LICENSING%20AGREEMENTS%20AND%20COLLABORATIONS) Key licensing agreements with Dana-Farber, Adimab, NeuPharma, and Jubilant involve upfront fees, milestones, and royalties for pipeline development - Licensed its core antibody portfolio (PD-L1, GITR, CAIX) from Dana-Farber, with potential milestone payments of approximately **$21.5 million per product** for development and regulatory achievements, plus up to **$60.0 million in sales milestones** and royalties[628](index=628&type=chunk) - Licensed **olafertinib** from NeuPharma, with eligibility for up to **$39.0 million in clinical/regulatory milestones** and **$40.0 million in sales milestones**, plus tiered royalties[72](index=72&type=chunk) - Licensed the **BET inhibitor program (CK-103)** from Jubilant, involving a **$2.0 million upfront fee** and potential for approximately **$88.4 million in clinical/regulatory milestones** and **$89.3 million in sales milestones**, plus royalties[40](index=40&type=chunk) - Collaborated with Adimab to optimize cosibelimab, with Adimab eligible for up to **$2.5 million in regulatory milestone payments** and **low single-digit royalties**. A **$2.2 million milestone** was expensed in **February 2023** upon FDA's BLA filing acceptance[39](index=39&type=chunk) [Competition](index=22&type=section&id=COMPETITION) Checkpoint faces intense competition in immuno-oncology and EGFR inhibitor markets from major pharmaceutical companies - Competes with **established PD-1/PD-L1 inhibitors** from major pharmaceutical companies such as Merck (**Keytruda®**), Bristol-Myers Squibb (**Opdivo®**), and Roche (**Tecentriq®**)[632](index=632&type=chunk) - In the **EGFR inhibitor market for NSCLC**, the company faces competition from approved drugs including AstraZeneca's **Tagrisso®**, as well as products in development from Novartis and Janssen[98](index=98&type=chunk) [Supply and Manufacturing](index=24&type=section&id=SUPPLY%20AND%20MANUFACTURING) Checkpoint relies entirely on single-source third-party contract manufacturers, posing significant risks to supply, compliance, and production - The company relies on **single contract manufacturers** for each of its product candidates, creating a **significant dependency** and **risk of supply disruption**[44](index=44&type=chunk)[634](index=634&type=chunk) - **Switching manufacturers** is a **difficult and time-consuming process** that requires **advance approval from the FDA** and other regulatory agencies, which could lead to **significant delays**[77](index=77&type=chunk) [Government and Industry Regulations](index=24&type=section&id=GOVERNMENT%20AND%20INDUSTRY%20REGULATIONS) The company operates in a heavily regulated industry, requiring rigorous FDA approval, with ongoing oversight and uncertainty regarding pricing and reimbursement - All product candidates must undergo a **rigorous, lengthy, and expensive regulatory approval process**, including preclinical studies and sequential clinical trials (**Phase 1, 2, 3**) before they can be marketed[45](index=45&type=chunk)[101](index=101&type=chunk)[637](index=637&type=chunk) - The FDA may grant **expedited review designations** such as **'Fast Track'** for drugs intended to treat serious conditions and fill an unmet medical need, potentially allowing for a more efficient review process[102](index=102&type=chunk)[636](index=636&type=chunk) - **Commercial success** depends on securing **adequate reimbursement** from **third-party payors**, including government programs and private insurers, who are increasingly scrutinizing the cost-effectiveness of new drugs. The **Inflation Reduction Act** may also impact drug profitability[107](index=107&type=chunk) [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) Checkpoint faces significant risks including substantial losses, going concern doubt, third-party reliance, competition, IP challenges, and Fortress Biotech control [Risks Related to Finances and Capital Requirements](index=30&type=section&id=Risks%20Related%20to%20Our%20Finances%20and%20Capital%20Requirements) The company has significant losses, a **$314.3 million** accumulated deficit, and substantial doubt about its going concern ability, requiring additional Q3 2024 funding - The company has incurred **significant losses** since inception, with an **accumulated deficit of $314.3 million** as of **December 31, 2023**, and anticipates continued losses[109](index=109&type=chunk)[110](index=110&type=chunk) - There is **substantial doubt** about the company's ability to continue as a **going concern**, as its current cash and cash equivalents are only projected to fund operations into the **third quarter of 2024**[114](index=114&type=chunk)[117](index=117&type=chunk)[143](index=143&type=chunk) - The company requires **substantial additional funding** to continue development and commercialization, and failure to secure it could **significantly harm the business**[90](index=90&type=chunk)[92](index=92&type=chunk) [Risks Inherent in Drug Development and Commercialization](index=40&type=section&id=Risks%20Inherent%20in%20Drug%20Development%20and%20Commercialization) Drug development is inherently risky; early trial results are not predictive, and cosibelimab's BLA relies on potentially insufficient single-trial data - Preclinical and early clinical trial results are **not necessarily predictive of future success**, and product candidates often **fail in later-stage trials** despite initial promise[132](index=132&type=chunk)[159](index=159&type=chunk) - The BLA submission for cosibelimab relies on data from a **single, primarily foreign clinical trial**. The FDA may require additional studies, which would cause **significant delays and expense**[156](index=156&type=chunk) - **Serious or unacceptable side effects** identified during development could lead to the **abandonment** of a product candidate or **significant limitations** on its use[13](index=13&type=chunk)[209](index=209&type=chunk) - Even with regulatory approval, **commercial success is not guaranteed** and depends on **market acceptance** by physicians, patients, and payors, as well as **adequate reimbursement**[138](index=138&type=chunk)[186](index=186&type=chunk) [Risks Related to Reliance on Third Parties](index=56&type=section&id=Risks%20Related%20to%20Reliance%20on%20Third%20Parties) Checkpoint's heavy reliance on third-party CMOs and CROs, highlighted by the cosibelimab CRL, poses significant development and commercialization risks - The company has **no manufacturing facilities** and relies on **third-party contractors** for all clinical and potential commercial supply, increasing **risks of delays and quality control issues**[228](index=228&type=chunk)[258](index=258&type=chunk) - The FDA issued a **CRL** for the cosibelimab BLA due to **inspection issues** at its **third-party contract manufacturer**, underscoring the **direct impact** of **third-party compliance** on regulatory approval timelines[232](index=232&type=chunk) - The company depends on **third-party CROs** to conduct its clinical trials, and any failure by these CROs to perform satisfactorily or meet regulatory standards (like GCPs) could **compromise trial data** and **delay approvals**[225](index=225&type=chunk)[226](index=226&type=chunk)[254](index=254&type=chunk) [Risks Related to Intellectual Property and Potential Disputes with Licensors Thereof](index=68&type=section&id=Risks%20Related%20to%20Intellectual%20Property%20and%20Potential%20Disputes%20with%20Licensors%20Thereof) Checkpoint's success depends on maintaining patent protection for in-licensed technologies, facing infringement, validity challenges, and licensor disputes - **Commercial success** depends on maintaining **valid and enforceable patent protection**, which is **uncertain** and involves **complex legal questions**[277](index=277&type=chunk)[302](index=302&type=chunk) - The company **depends on its licensors** to maintain and enforce the intellectual property for its product candidates and has **limited control** over their actions, creating a **risk of losing patent rights**[285](index=285&type=chunk)[286](index=286&type=chunk)[310](index=310&type=chunk) - The company may become involved in **expensive and time-consuming lawsuits** to protect its patents or defend against **infringement claims** from competitors[288](index=288&type=chunk)[338](index=338&type=chunk) - Any **disputes with licensors** over obligations in license agreements could result in the **loss of rights to key product candidates**[315](index=315&type=chunk)[342](index=342&type=chunk) [Risks Relating to Our Control by Fortress Biotech Inc.](index=80&type=section&id=Risks%20Relating%20to%20Our%20Control%20by%20Fortress%20Biotech%20Inc.) Fortress Biotech controls a voting majority of Checkpoint's common stock, influencing all stockholder matters and causing ongoing dilution - Fortress controls a **voting majority** of the company's common stock, enabling it to **control stockholder votes** on all major corporate actions[164](index=164&type=chunk)[351](index=351&type=chunk) - Under the Founders Agreement, Fortress receives an **annual grant of shares** equal to **2.5%** of the company's **fully diluted equity**, causing **dilution** to other stockholders[326](index=326&type=chunk)[352](index=352&type=chunk) - Agreements with Fortress, such as the Management Services Agreement, may **not be on terms as favorable** as those that could be obtained from unaffiliated third parties[137](index=137&type=chunk)[327](index=327&type=chunk) [Cybersecurity](index=86&type=section&id=Item%201C.%20Cybersecurity) Checkpoint manages cybersecurity risks via management and Audit Committee oversight, third-party assessments, and training, with no material threats - The company's **management team** is responsible for assessing and managing cybersecurity risks, with oversight provided by the **Audit Committee**[367](index=367&type=chunk)[394](index=394&type=chunk) - Cybersecurity risk management strategies include engaging **third-party experts**, deploying **detection and response services**, and ongoing **employee training**[364](index=364&type=chunk)[391](index=391&type=chunk) - **No cybersecurity threats** have been identified in the **last two fiscal years** that are deemed reasonably likely to have a **material impact** on the company's business or financial condition[393](index=393&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=89&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Common stock trades on NASDAQ under "CKPT", no cash dividends paid, earnings retained for growth, with equity compensation plan details - The company's common stock trades on the **NASDAQ Capital Market** under the ticker symbol **"CKPT"**[396](index=396&type=chunk) - The company has **never paid cash dividends** and **does not intend to** in the foreseeable future, retaining any earnings for business development[371](index=371&type=chunk) Securities Authorized for Issuance under Equity Compensation Plans (as of Dec 31, 2023) | Plan Category | Securities to be issued upon exercise of outstanding options | Weighted-average exercise price of outstanding options | Securities remaining available for future issuance | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by security holders | 127,000 | $8.88 | 3,510,830 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=90&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) As a clinical-stage company, Checkpoint has no product revenue, significant operating losses, a **$314.3 million** accumulated deficit, and critical liquidity [Results of Operations](index=94&type=section&id=Results%20of%20Operations) In 2023, revenue was negligible at **$0.1 million**, R&D expenses decreased to **$43.6 million**, and G&A expenses remained stable Comparison of Operating Results (Years Ended Dec 31) | Metric (in millions) | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Revenue | $0.1 | $0.2 | ($0.1) | | Research & Development Expenses | $43.6 | $49.8 | ($6.2) | | General & Administrative Expenses | $8.7 | $8.7 | $0.0 | - The **decrease in 2023 R&D expenses** was mainly driven by **lower commercial manufacturing costs** for cosibelimab (**$19.0M in 2023** vs. **$25.3M in 2022**) and reduced clinical costs[415](index=415&type=chunk) - The company anticipates that **R&D expenses will decrease in 2024** compared to 2023, while **G&A expenses are expected to remain relatively consistent**[173](index=173&type=chunk)[442](index=442&type=chunk) [Liquidity and Capital Resources](index=98&type=section&id=Liquidity%20and%20Capital%20Resources) Cash from equity sales, including **$40.5 million** net financing in 2023, is only sufficient into Q3 2024, raising going concern doubt - The company's **cash and cash equivalents** are only **sufficient** to fund operating expenses into the **third quarter of 2024**, raising **substantial doubt** about its ability to continue as a **going concern**[470](index=470&type=chunk) - In **2023**, the company raised capital through several **registered direct offerings** in **February ($6.7M net)**, **April ($5.5M net)**, **May ($9.1M net)**, and **July ($9.1M net)**, as well as an **inducement offer** for **warrant exercises** in **October ($10.0M net)**[422](index=422&type=chunk)[448](index=448&type=chunk)[449](index=449&type=chunk)[467](index=467&type=chunk)[469](index=469&type=chunk) Cash Flow Summary (Years Ended Dec 31) | Cash Flow (in millions) | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($47.6) | ($57.6) | | Net cash provided by financing activities | $40.5 | $14.9 | [Controls and Procedures](index=104&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded disclosure controls and internal control over financial reporting were effective as of **December 31, 2023** - **Management concluded** that as of **December 31, 2023**, the company's **disclosure controls and procedures were effective**[476](index=476&type=chunk) - **Management assessed internal control over financial reporting** using the **COSO framework** and **concluded it was effective** as of **December 31, 2023**[477](index=477&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=104&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Director, executive officer, and corporate governance information is incorporated by reference from the **2024 Proxy Statement** - Information regarding directors, executive officers, and corporate governance is **incorporated by reference** from the **2024 Proxy Statement**[463](index=463&type=chunk) [Executive Compensation](index=105&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation details are incorporated by reference from the **2024 Annual Meeting of Stockholders Proxy Statement** - Information regarding executive compensation is **incorporated by reference** from the **2024 Proxy Statement**[483](index=483&type=chunk)[504](index=504&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=105&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Security ownership for major shareholders and management is incorporated by reference from the **2024 Proxy Statement** - Information regarding security ownership is **incorporated by reference** from the **2024 Proxy Statement**[464](index=464&type=chunk)[505](index=505&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=105&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Related party transactions and director independence are incorporated by reference from the **2024 Proxy Statement** - Information regarding related transactions and director independence is **incorporated by reference** from the **2024 Proxy Statement**[506](index=506&type=chunk) [Principal Accountant Fees and Services](index=105&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Principal accountant fees and services information is incorporated by reference from the **2024 Proxy Statement** - Information regarding principal accountant fees and services is **incorporated by reference** from the **2024 Proxy Statement**[507](index=507&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=106&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section presents audited financial statements for **2023** and **2022**, including the independent auditor's report and all Form 10-K exhibits [Report of Independent Registered Public Accounting Firm](index=115&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) KPMG LLP issued a fair opinion, but highlighted **substantial doubt** about going concern and identified a warrant inducement transaction as a **critical audit matter** - The auditor's report contains a **"Going Concern" paragraph**, explicitly stating that the company's **recurring losses** and **net capital deficiency** raise **substantial doubt** about its ability to continue as a **going concern**[500](index=500&type=chunk)[527](index=527&type=chunk) - A **critical audit matter** was identified related to the accounting for a **warrant inducement transaction** in **October 2023**, which required **complex judgment** regarding accounting guidance and the **fair value estimation** of the warrants[503](index=503&type=chunk)[537](index=537&type=chunk)[538](index=538&type=chunk) [Financial Statements](index=117&type=section&id=Financial%20Statements) As of **December 31, 2023**, cash decreased to **$4.9 million**, total liabilities exceeded assets, resulting in a **$13.0 million** stockholders' deficit Consolidated Balance Sheet Data (in thousands) | Account | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $4,928 | $12,068 | | Total Assets | $5,378 | $13,290 | | Total Liabilities | $18,425 | $32,773 | | Total Stockholders' Equity (Deficit) | ($13,047) | ($19,483) | Consolidated Statement of Operations Data (in thousands) | Account | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Revenue | $103 | $192 | | Total operating expenses | $52,251 | $58,525 | | Net Loss | ($51,847) | ($62,624) | | Basic and diluted net loss per share | ($3.17) | ($7.09) |

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended, that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding our ability to work with our third- ...

WALTHAM, Mass., March 22, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the full-year ended December 31, 2023, and recent corporate highlights. James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We continue to work closely with our third-party contract manufacturing organization to expeditiously resolve the deficiencies noted in the complete r ...

WALTHAM, Mass., March 18, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the appointment of Amit Sharma, M.D., FACP, FASN, FNKF, to its Board as an independent, non-executive director, effective immediately. Dr. Sharma currently serves as Vice President of Clinical Development and Therapeutic Head for Nephrology and Hematology at Alexion, AstraZeneca Rare Disease, where he guides and executes ...

WALTHAM, Mass., Jan. 29, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that it has entered into a definitive agreement with a single healthcare-dedicated institutional investor for the issuance and sale of an aggregate of 7,756,233 shares of its common stock (or common stock equivalents in lieu thereof) at a purchase price of $1.805 per share of common stock (or per common stock equivalent in ...

Table of Contents FORM 10-Q For the transition period from _________ to _________ Commission File Number 001-38128 Class of Common Stock Outstanding Shares as of November 10, 2023 Class A Common Stock, $0.0001 par value 700,000 Common Stock, $0.0001 par value 22,826,035 Table of Contents 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 ...