Checkpoint Therapeutics Q1 2024 Financial Results and Corporate Updates
WALTHAM, Mass., May 10, 2024 – Checkpoint Therapeutics, Inc. (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology firm, recently shared its financial results for the first quarter ended March 31, 2024, along with noteworthy corporate updates. President and CEO James F. Oliviero discussed the company's ongoing efforts with its third-party contract manufacturing organization (CMO) to address inspection issues highlighted in a complete response letter (CRL) from the U.S. FDA received last December. The CMO has since submitted a response to the FDA's inspection deficiencies, which might allow for the resubmission of their biologics license application (BLA) for cosibelimab. Checkpoint aims to discuss and potentially align on a mid-year BLA resubmission with the FDA soon.
Corporate Updates:
In January 2023, Checkpoint submitted a BLA to the FDA for cosibelimab, targeting approval as a treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation. The FDA accepted this BLA in March 2023. However, in December 2023, the FDA issued a CRL, citing only the CMO's inspection findings as approvability issues, without concerns regarding the clinical data package, safety, or labeling. Checkpoint plans to address this feedback, targeting a mid-year BLA resubmission.
Additionally, in January 2024, Checkpoint raised approximately $14.0 million through a registered direct offering and a concurrent private placement of warrants to purchase common stock. In March 2024, Amit Sharma, M.D., FACP, FASN, FNKF, was appointed as a non-executive director to the Board of Directors. Dr. Sharma is a life sciences executive currently serving as Vice President of Clinical Development and Therapeutic Head for Nephrology and Hematology at Alexion, AstraZeneca Rare Disease.
Financial Results:
As of March 31, 2024, Checkpoint's cash and cash equivalents stood at $11.2 million, a significant increase from the $4.9 million reported on December 31, 2023. The improvement is attributed to the recent fundraising activities.
Research and development (R&D) expenses for the first quarter of 2024 were $8.5 million, down from $15.8 million during the same period in 2023, reflecting a $7.3 million decrease. This decrease included $0.5 million of non-cash stock expenses, compared to $0.4 million in the first quarter of 2023.
General and administrative (G&A) expenses for the first quarter of 2024 were $2.5 million, slightly higher than the $2.3 million recorded in the first quarter of 2023. This included $0.6 million of non-cash stock expenses, compared to $0.7 million in the prior year.
The net loss attributable to common stockholders for Q1 2024 was $10.9 million, or $0.33 per share, compared to a net loss of $10.5 million, or $0.89 per share, during Q1 2023. Both periods included $1.1 million of non-cash stock expenses.
About Checkpoint Therapeutics:
Checkpoint Therapeutics, Inc. is an immunotherapy and targeted oncology company in the clinical stage, focusing on developing novel treatments for solid tumor cancers. Its lead antibody product candidate, cosibelimab, is designed to treat selected recurrent or metastatic cancers, including metastatic and locally advanced cSCC. Additionally, Checkpoint is developing olafertinib (formerly CK-101), a targeted anti-cancer agent for EGFR mutation-positive non-small cell lung cancer. Established by Fortress Biotech, Inc. and headquartered in Waltham, MA, Checkpoint continues to pursue advancements in cancer treatment solutions.
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