Checkpoint Therapeutics Reports First Quarter Financial Results and Recent Corporate Updates

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UNLOXCYT™ (cosibelimab-ipdl) approved by U.S. FDA in December 2024 as first and only anti-PD-L1 treatment for advanced cutaneous squamous cell carcinoma Special meeting of stockholders to vote on Merger to take place on May 28, 2025 WALTHAM, Mass. , May 13, 2025 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a commercial-stage immunotherapy and targeted oncology company, today announced financial results for the first quarter ended March 31, 2025 , and recent corporate updates. Recent Corporate Updates: In December 2024 , Checkpoint announced that the U.S. Food and Drug Administration (“FDA”) approved UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. UNLOXCYT is the first and only programmed death ligand-1 (“PD-L1”) blocking antibody to receive FDA marketing approval for this indication. In March 2025 , Checkpoint announced that it entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Sun Pharmaceutical Industries, Inc. (“Sun Pharma”), and a wholly owned subsidiary of Sun Pharma, with Checkpoint continuing as the surviving corporation of the transaction and a wholly owned subsidiary of Sun Pharma (the “Merger”). The total transaction value of the Merger, including the upfront cash payment and the maximum value of the contingent value right (“CVR”), is up to approximately $416 million , and the Merger is expected to be completed in the second quarter of 2025. The transaction is subject to customary closing conditions, including required regulatory approvals and approval by the requisite majorities of Checkpoint’s stockholders. In April 2025 , the Merger Agreement was amended. Also in April 2025 , Checkpoint filed the definitive proxy statement relating to the Merger. The special meeting of Checkpoint stockholders to vote on the Merger will be held on May 28, 2025 . Financial Results: Cash Position : As of March 31, 2025 , Checkpoint’s cash and cash equivalents totaled $33.0 million , compared to $6.6 million at December 31, 2024 , an increase of $26.4 million . R&D Expenses : Research and development expenses for the first quarter of 2025 were $3.8 million , compared to $8.5 million for the first quarter of 2024, a decrease of $4.7 million . Research and development expenses for the first quarter of 2025 included $0.7 million of non-cash stock expenses, compared to $0.5 million for the first quarter of 2024. G&A Expenses : General and administrative expenses for the first quarter of 2025 were $7.4 million , compared to $2.5 million for the first quarter of 2024, an increase of $4.9 million . General and administrative expenses for the first quarter of 2025 included $1.3 million of non-cash stock expenses, compared to $0.6 million for the first quarter of 2024. Net Loss : Net loss attributable to common stockholders for the first quarter of 2025 was $11.2 million , or $0.19 per share, compared to a net loss of $10.9 million , or $0.33 per share, in the first quarter of 2024. Net loss for the first quarter of 2025 included $2.0 million of non-cash stock expenses, compared to $1.1 million for the first quarter of 2024. About UNLOXCYT™ (cosibelimab-ipdl) UNLOXCYT is a human immunoglobulin G1 monoclonal antibody that binds PD-L1 and blocks the interaction between PD-L1 and its T cell receptors, PD-1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the anti-tumor immune response. UNLOXCYT has also been shown to induce antibody-dependent cell-mediated cytotoxicity. INDICATION and IMPORTANT SAFETY INFORMATION INDICATION UNLOXCYT (cosibelimab-ipdl) is indicated for the treatment of adults with metastatic cSCC or locally advanced cSCC who are not candidates for curative surgery or curative radiation. IMPORTANT SAFETY INFORMATION Severe and Fatal Immune-Mediated Adverse Reactions Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions. Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue, and occur at any time after starting a PD-1/PD-L1–blocking antibody, including UNLOXCYT. While immune-mediated adverse reactions usually manifest during treatment, they can also manifest after discontinuation of PD-1/PD-L1–blocking antibodies. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. Monitor closely for signs and symptoms of immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function tests at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue UNLOXCYT depending on the severity of the adverse reaction (see Dosage and Administration in Prescribing Information ). In general, if UNLOXCYT requires interruption or discontinuation, administer systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroids. Immune-Mediated Pneumonitis UNLOXCYT can cause immune-mediated pneumonitis. In patients treated with other PD-1/PD-L1–blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 1% (3/223, Grade 2) of patients receiving UNLOXCYT. Immune-Mediated Colitis UNLOXCYT can cause immune-mediated colitis, which may present with diarrhea, abdominal pain, and lower gastrointestinal bleeding. Cytomegalovirus infection/reactivation has occurred in patients with corticosteroid-refractory immune-mediated colitis treated with PD-1/PD-L1–blocking antibodies. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 0.4% (1/223, Grade 1) of patients receiving UNLOXCYT. Immune-Mediated Hepatitis UNLOXCYT can cause immune-mediated hepatitis. Immune-Mediated Endocrinopathies Adrenal Insufficiency UNLOXCYT can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment per institutional guidelines, including hormone replacement as clinically indicated. Withhold or permanently discontinue UNLOXCYT depending on severity. Adrenal insufficiency occurred in 0.9% (2/223) of patients receiving UNLOXCYT, including Grade 2 in 0.4% (1/223) of patients. Hypophysitis UNLOXCYT can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated. Withhold or permanently discontinue UNLOXCYT depending on severity. Thyroid Disorders UNLOXCYT can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement or medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue UNLOXCYT depending on severity. Hypothyroidism occurred in 10% (22/223) of patients receiving UNLOXCYT, including Grade 2 in 5% (10/223) of patients. Hyperthyroidism occurred in 5% (12/223) of patients receiving UNLOXCYT, including Grade 2 in 0.4% (1/223) of patients. Type 1 Diabetes Mellitus, Which Can Present with Diabetic Ketoacidosis UNLOXCYT can cause type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold or permanently discontinue UNLOXCYT depending on severity. Immune-Mediated Nephritis with Renal Dysfunction UNLOXCYT can cause immune-mediated nephritis. Immune-Mediated Dermatologic Adverse Reactions UNLOXCYT can cause immune-mediated rash or dermatitis. Bullous and exfoliative dermatitis, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms, have occurred with PD-1/PD-L1–blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes. Withhold or permanently discontinue UNLOXCYT depending on severity. Immune-mediated dermatologic adverse reactions occurred in 7% (15/223) of patients receiving UNLOXCYT, including Grade 3 in 0.9% (2/223) of patients and Grade 2 in 4% (9/223) of patients. Other Immune-Mediated Adverse Reactions The following clinically significant immune-mediated adverse reactions occurred in

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