On May 10, 2024 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the first quarter ended March 31, 2024, and recent corporate updates (Press release, Checkpoint Therapeutics, MAY 10, 2024, View Source [SID1234643077]).
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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 inspection deficiencies noted in the complete response letter ("CRL") we received from the U.S. Food and Drug Administration ("FDA") last December. Recently, our CMO submitted to FDA their response to the inspection deficiencies, which we believe could allow for the resubmission of our biologics license application ("BLA"). We plan to meet with the FDA shortly, at which time we will seek to reach alignment for a potential mid-year BLA resubmission."
Recent Corporate Updates:
Checkpoint submitted a BLA to the FDA in January 2023 seeking approval of cosibelimab as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or curative radiation, and the FDA accepted the BLA for filing in March 2023. In December 2023, the FDA issued a CRL for the cosibelimab BLA. The CRL only cited findings that arose during a multi-sponsor inspection of Checkpoint’s third-party CMO as approvability issues to address in a BLA resubmission. The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab. Checkpoint intends to seek to address the feedback in a potential BLA resubmission, which is currently targeted for mid-year.
In January 2024, Checkpoint completed a registered direct offering priced At-the-Market under Nasdaq rules and a concurrent private placement of warrants to purchase Checkpoint common stock, for total gross proceeds of approximately $14.0 million.
In March 2024, Checkpoint announced the appointment of life sciences executive, Amit Sharma, M.D., FACP, FASN, FNKF, currently Vice President of Clinical Development and Therapeutic Head for Nephrology and Hematology at Alexion, AstraZeneca Rare Disease, as a non-executive director to Checkpoint’s Board of Directors.
Financial Results:
Cash Position: As of March 31, 2024, Checkpoint’s cash and cash equivalents totaled $11.2 million, compared to $4.9 million at December 31, 2023, an increase of $6.3 million.
R&D Expenses: Research and development expenses for the first quarter of 2024 were $8.5 million, compared to $15.8 million for the first quarter of 2023, a decrease of $7.3 million. Research and development expenses for the first quarter of 2024 included $0.5 million of non-cash stock expenses, compared to $0.4 million for the first quarter of 2023.
G&A Expenses: General and administrative expenses for the first quarter of 2024 were $2.5 million, compared to $2.3 million for the first quarter of 2023, an increase of $0.2 million. General and administrative expenses for the first quarter of 2024 included $0.6 million of non-cash stock expenses, compared to $0.7 million for the first quarter of 2023.
Net Loss: Net loss attributable to common stockholders for the first quarter of 2024 was $10.9 million, or $0.33 per share, compared to a net loss of $10.5 million, or $0.89 per share, in the first quarter of 2023. Net loss for the first quarter of 2024 and 2023 both included $1.1 million of non-cash stock expenses.