Table of Contents 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 June 30, 2024 OR ☐ 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) ...

Exhibit 99.1 Checkpoint Therapeutics Reports Second Quarter 2024 Financial Results and Recent Corporate Updates Waltham, MA – August 12, 2024 – Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the second quarter ended June 30, 2024, and recent corporate updates. James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We've made significant recent progress as we seek approval ...

WALTHAM, Mass., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the second quarter ended June 30, 2024, and recent corporate updates. James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We've made significant recent progress as we seek approval of cosibelimab as a potential new treatment for patients with metastatic or locally advanced ...

Core Viewpoint - The FDA has accepted Checkpoint Therapeutics' resubmission of the Biologics License Application (BLA) for cosibelimab, indicating a positive step towards potential approval for treating metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) [7]. Group 1: Company Overview - Checkpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncology company focused on developing novel treatments for solid tumor cancers [3]. - The company is headquartered in Waltham, MA, and was founded by Fortress Biotech, Inc. [3]. - Checkpoint is evaluating cosibelimab, an anti-PD-L1 antibody, and olafertinib, a third-generation EGFR inhibitor, for potential treatments in specific cancer types [3]. Group 2: Product Details - Cosibelimab is a fully-human monoclonal antibody that binds to PD-L1, blocking its interaction with PD-1 and B7.1 receptors, thereby enhancing the anti-tumor response of CD8+ T-cells [2]. - The antibody is differentiated from existing PD-1 and PD-L1 therapies due to its sustained high tumor target occupancy and potential for enhanced efficacy through antibody-dependent cellular cytotoxicity (ADCC) [2]. Group 3: Regulatory Update - The FDA issued a Complete Response Letter (CRL) in December 2023, citing issues related to a third-party contract manufacturing organization, but did not express concerns regarding the clinical data package or safety [1]. - The resubmission of the BLA has been accepted as a complete response, with a Prescription Drug User Fee Act (PDUFA) goal date set for December 28, 2024 [7].

James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We are pleased that the FDA has accepted our BLA resubmission as a complete response after we aligned on our BLA resubmission strategy. We look forward to working closely with the FDA to finalize the review and to the potential opportunity to deliver cosibelimab's unique dual mechanism of action to patients suffering from cSCC." In December 2023, the FDA issued a CRL for the cosibelimab BLA, which only cited findings that arose d ...

Collaboration explores the potential synergistic effects of Checkpoint's anti-PD-L1, cosibelimab, in combination with the autologous T cell therapy, Immuncell-LC This collaboration will initially focus on conducting in vitro combination studies to evaluate the synergistic effects of these two therapies on cancer cell destruction. Positive preliminary data from these studies could potentially pave the way for future in vivo research and clinical studies. James Park, CEO of GC Cell, highlighted the agreement' ...

YONGIN, South Korea and WALTHAM, Mass., July 15, 2024 (GLOBE NEWSWIRE) -- GC Cell (KRX: 144510.KS) and Checkpoint Therapeutics ("Checkpoint") (Nasdaq: CKPT) have announced a collaboration to explore the combined therapeutic potential of cosibelimab, Checkpoint's anti-PD-L1 antibody with dual mechanism of action, with GC Cell's Immuncell-LC, an innovative autologous Cytokine Induced Killer ("CIK") T cell therapy composed of cytotoxic T lymphocytes and natural killer T cells. The anticipated synergy between c ...

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The shares of common stock (or common stock equivalents) described above (but not the unregistered warrants issued in the concurrent private placement or the shares of common stock underlying such unregistered warrants) are being offered by Checkpoint pursuant to a shelf registration statement on Form S-3 (File No. 333- 270843) that was previously filed with the Securities and Exchange Commission ("SEC") on March 24, 2023, an ...

WALTHAM, Mass., July 02, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced it has completed the resubmission of its Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for cosibelimab, its anti-programmed death ligand-1 ("PD-L1") antibody, as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") wh ...

Core Viewpoint - Checkpoint Therapeutics has resubmitted its Biologics License Application (BLA) for cosibelimab to the FDA, aiming to address previous approvability deficiencies and seeking approval for treating patients with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation [5][4]. Company Overview - Checkpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncology company focused on developing novel treatments for solid tumor cancers [2]. - The company is evaluating cosibelimab, an anti-PD-L1 antibody, and olafertinib, a third-generation EGFR inhibitor, for various cancer treatments [2]. Product Details - Cosibelimab is a fully-human monoclonal antibody that inhibits the interaction between PD-L1 and its receptors, potentially enhancing anti-tumor immune responses [6]. - The drug has shown promising results in pivotal studies, with a 55% objective response rate and a 26% complete response rate in locally advanced cSCC, and a 50% objective response rate and a 13% complete response rate in metastatic cSCC [1]. Regulatory Progress - The BLA resubmission follows alignment with the FDA on addressing issues raised in a previous complete response letter (CRL), which did not express concerns about the clinical data package [4]. - The resubmission is supported by recent study results published in October 2023, indicating the efficacy and safety of cosibelimab in treating selected recurrent or metastatic cancers [9].