On May 15, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the first quarter ended March 31, 2023, and recent corporate highlights (Press release, Checkpoint Therapeutics, MAY 15, 2023, View Source [SID1234631706]).

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"The first quarter of 2023 began a transformative year for Checkpoint, with our January submission of a Biologics License Application ("BLA") for cosibelimab in patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC"), followed by the FDA’s acceptance of the BLA filing in March, in which they indicated that no potential filing review issues have been identified and that an advisory committee meeting to discuss the application is not currently planned," said James Oliviero, President and Chief Executive Officer of Checkpoint. "We continue to prepare for a potential commercial launch in 2024, while simultaneously progressing active discussions with multiple third parties to evaluate potential partnerships and other types of corporate development transactions."

Mr. Oliviero continued, "If approved, based on its compelling efficacy and safety profile, we believe cosibelimab has the potential to capture significant market share in this $1.6 billion U.S. market opportunity through positioning as a differentiated and possibly best-in-class treatment for patients with cutaneous squamous cell carcinoma."

Recent Corporate Highlights:

Checkpoint submitted a BLA to the FDA seeking approval of cosibelimab in January 2023. In March 2023, Checkpoint announced the FDA accepted the BLA filing for cosibelimab and set a Prescription Drug User Fee Act ("PDUFA") goal date of January 3, 2024. In its BLA filing acceptance letter, the FDA indicated that no potential filing review issues have been identified, and that an advisory committee meeting to discuss the application is not currently planned.
In February 2023, Checkpoint completed a registered direct offering priced at-the-market under Nasdaq rules and a concurrent private placement of two series of warrants to purchase Checkpoint common stock, for total gross proceeds of approximately $7.5 million.
In April 2023, Checkpoint completed another registered direct offering priced at-the-market under Nasdaq rules and a concurrent private placement of two series of warrants to purchase Checkpoint common stock, for total gross proceeds of approximately $6.1 million.
Financial Results:

Cash Position: As of March 31, 2023, Checkpoint’s cash and cash equivalents totaled $4.8 million, compared to $12.1 million at December 31, 2022, a decrease of $7.3 million. Subsequent to the end of the quarter, Checkpoint raised approximately $6.1 million of gross proceeds in a registered direct offering completed in April 2023.
R&D Expenses: Research and development expenses for the first quarter of 2023 were $15.8 million, compared to $14.7 million for the first quarter of 2022, an increase of $1.1 million. Research and development expenses for the first quarter of 2023 included $0.4 million of non-cash stock expenses, compared to $0.2 million for the first quarter of 2022.
G&A Expenses: General and administrative expenses for the first quarter of 2023 were $2.3 million, compared to $2.2 million for the first quarter of 2022, an increase of $0.1 million. General and administrative expenses for the first quarter of 2023 and 2022 both included $0.7 million of non-cash stock expenses.
Net Loss: Net loss attributable to common stockholders for the first quarter of 2023 was $10.5 million, or $0.89 per share, compared to a net loss of $16.8 million, or $1.98 per share, in the first quarter of 2022. Net loss for the first quarter of 2023 included $1.1 million of non-cash stock expenses, compared to $0.9 million for the first quarter of 2022.