Core Insights - Checkpoint Therapeutics is awaiting a decision from the U.S. FDA on its Biologics License Application (BLA) resubmission for cosibelimab, with a PDUFA goal date set for December 28, 2024 [2][3] - The company has strengthened its financial position with $9.2 million in cash proceeds from warrant exercises, allowing it to extend operations beyond the PDUFA date into 2025 [2][3] - Checkpoint is focused on preparing for the potential approval of cosibelimab, which is aimed at treating advanced cutaneous squamous cell carcinoma (cSCC) [2][3] Recent Corporate Updates - The FDA accepted the resubmission of the BLA for cosibelimab in July 2024, addressing issues from a previous complete response letter issued in December 2023 [3] - A collaboration was announced in July 2024 to explore the combined therapeutic potential of cosibelimab with GC Cell's Immuncell-LC [3] - Checkpoint completed a direct offering and private placement in July 2024, raising approximately $12.0 million [3] - Longer-term data from a pivotal trial of cosibelimab was presented at the ESMO Congress 2024, showing improved response rates over time [3] - The company received $9.2 million in cash proceeds from warrant exercises in November 2024 [3] Financial Results - As of September 30, 2024, Checkpoint's cash and cash equivalents totaled $4.7 million, a decrease from $5.0 million at June 30, 2024 [4] - Research and development expenses for Q3 2024 were $6.4 million, up from $5.5 million in Q3 2023 [4] - General and administrative expenses for Q3 2024 were $3.4 million, compared to $2.2 million in Q3 2023 [4] - The net loss for Q3 2024 was $9.7 million, or $0.23 per share, compared to a net loss of $5.7 million, or $0.29 per share, in Q3 2023 [4][10]
Checkpoint Therapeutics Reports Third Quarter 2024 Financial Results and Recent Corporate Updates