Checkpoint Therapeutics Q2 2024 Financial Results and Corporate Updates

Checkpoint Therapeutics, Inc., based in Waltham, Massachusetts, has recently released its financial results for the second quarter ending June 30, 2024. The company, which operates in the field of immunotherapy and targeted oncology, also provided updates on recent corporate developments. James F. Oliviero, the President and Chief Executive Officer of Checkpoint, emphasized the strides made toward securing approval for cosibelimab, a new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who cannot undergo curative surgery or radiation.

In December 2023, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) of cosibelimab. The CRL was based on findings during an inspection of Checkpoint's third-party contract manufacturing organization (CMO) and did not highlight any issues with the clinical data, safety, or labeling. Following this, Checkpoint resubmitted the BLA in June 2024 after aligning with the FDA on the resubmission strategy. By July 2024, the FDA accepted the resubmitted BLA as a complete response to the CRL and set a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024.

Checkpoint also revealed a collaboration with GC Cell to explore the combined therapeutic potential of cosibelimab and GC Cell’s Immuncell-LC, a novel autologous Cytokine Induced Killer T cell therapy composed of cytotoxic T lymphocytes and natural killer T cells. Concurrently, in July 2024, the company completed a registered direct offering and a private placement of warrants, raising approximately $12.0 million in gross proceeds.

Financially, as of June 30, 2024, Checkpoint reported cash and cash equivalents totaling $5.0 million, a decrease from $11.2 million at the end of March 2024. The company's research and development (R&D) expenses for the second quarter of 2024 were significantly reduced to $4.5 million from $13.9 million in the same quarter of the previous year. General and administrative (G&A) expenses also saw a slight decrease to $2.2 million from $2.3 million in the second quarter of 2023. The net loss attributable to common stockholders for the second quarter of 2024 was $6.7 million, compared to a $16.5 million net loss in the same period in 2023.

Checkpoint Therapeutics is focused on developing innovative treatments for solid tumor cancers. The company's lead product candidate, cosibelimab, is an anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, currently evaluated for treating selected recurrent or metastatic cancers, including metastatic and locally advanced cSCC. Additionally, Checkpoint is also developing olafertinib, a third-generation epidermal growth factor receptor (EGFR) inhibitor aimed at treating EGFR mutation-positive non-small cell lung cancer.

As Checkpoint continues to advance its pipeline, the upcoming FDA review for cosibelimab is a significant milestone. The company is optimistic about obtaining approval and providing a new therapeutic option for patients with cutaneous squamous cell carcinoma.