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Checkpoint Therapeutics reports developments in oncology drug commercialization, clinical regulation and corporate finance. The company focuses on immunotherapy and targeted oncology treatments for solid tumor cancers, including UNLOXCYT (cosibelimab-ipdl), an FDA-approved anti-PD-L1 antibody for adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation.
Recurring updates include FDA communications, Biologics License Application activity, commercial preparation for UNLOXCYT, and pipeline disclosures involving cosibelimab and olafertinib, a third-generation EGFR inhibitor for EGFR mutation-positive non-small cell lung cancer. Company news also covers operating results, capital-structure actions, material agreements, governance matters and shareholder voting topics.
Checkpoint Therapeutics (Nasdaq: CKPT) announced a $12 million registered direct offering with a healthcare-focused institutional investor. The deal includes 5,853,659 shares of common stock at $2.05 per share. Concurrently, Checkpoint will issue unregistered warrants for the same number of shares, exercisable at $2.05 per share post-shareholder approval and expiring in five years. H.C. Wainwright & Co. is the exclusive placement agent. The offering is expected to close around July 3, 2024. Gross proceeds will support working capital and general corporate purposes. Shares are offered under a previously filed and effective shelf registration statement with the SEC.
Checkpoint Therapeutics has resubmitted its Biologics License Application (BLA) to the FDA for cosibelimab, an anti-PD-L1 antibody aimed at treating metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC). The resubmission follows alignment with the FDA to address issues cited in a December CRL, which highlighted deficiencies found during a CMO inspection but did not raise concerns about clinical data, safety, or labeling. The BLA is supported by positive results from pivotal studies in cSCC, showing high objective and complete response rates, with longer-term data revealing deepening responses over time. Cosibelimab is a high-affinity, fully-human IgG1 subtype antibody designed to block PD-L1 interactions and potentially enhance anti-tumor immune responses.
Checkpoint Therapeutics has announced alignment with the FDA on its resubmission strategy for cosibelimab's biologics license application (BLA).
The BLA resubmission aims to gain U.S. marketing approval for cosibelimab as a treatment for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in patients unsuitable for curative surgery or radiation.
The alignment follows a complete response letter (CRL) from the FDA in December 2023, which identified issues with the contract manufacturing organization but did not raise concerns about clinical data, safety, or labeling.
Checkpoint Therapeutics, Inc. will participate in the H.C. Wainwright 2nd Annual BioConnect Investor Conference where James Oliviero, President and CEO, will have a fireside chat. The event will take place on May 20, 2024, at 12:30 p.m. ET at NASDAQ. Checkpoint will also have one-on-one meetings during the conference. A webcast of the fireside chat will be available on the News & Events page of Checkpoint's website for 30 days post-event.
Checkpoint Therapeutics, Inc. reported financial results for Q1 2024, revealing increased cash reserves, reduced R&D expenses, and an appointment to the Board of Directors. The company aims to address FDA feedback for potential BLA resubmission mid-year.
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