On November 8, 2022 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the third quarter ended September 30, 2022, and recent corporate highlights (Press release, Checkpoint Therapeutics, NOV 8, 2022, View Source [SID1234623521]).
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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "In the third quarter of 2022, we successfully completed two pre-Biologics License Application ("BLA") meetings with the U.S. Food and Drug Administration ("FDA"). Importantly, we continue to achieve significant progress toward our planned submission of a BLA by January of next year, which will include both the metastatic and locally advanced cutaneous squamous cell carcinoma ("cSCC") indications. We believe cosibelimab, with its differentiated two-fold mechanism of action, has the potential to be the first anti-PD-L1 antibody approved for advanced cSCC, which is the second most frequently diagnosed skin cancer, and provide physicians worldwide with an important new treatment option in the fight against this common and possibly deadly cancer. Our planned BLA submission will represent a significant milestone both for us as a company and for patients seeking treatment for cSCC."
"The reverse stock split recently approved by shareholders and planned for December is a proactive measure that we are confident will improve long-term liquidity and better position us for success by providing the opportunity for our stock to trade in a price range more attractive to a broader array of institutional investors. This increased visibility with institutional investors is critical as we continue our transition from a development-stage company to a fully integrated commercial organization to support the potential launch of cosibelimab."
Recent Corporate Highlights:
·In July 2022, Checkpoint successfully completed two pre-BLA meetings with the FDA (chemistry, manufacturing and controls [CMC] and clinical/non-clinical). Based upon favorable interactions with the agency, the planned BLA submission will include both the metastatic and locally advanced cutaneous squamous cell carcinoma indications. Checkpoint also reached agreement with the FDA on all key aspects discussed with regard to the content of the upcoming BLA submission.
·In November 2022, holders of a majority of the voting power of the capital stock of Checkpoint approved a 1-for-10 reverse stock split of the company’s common stock. Checkpoint expects its common shares will begin trading on a split-adjusted basis on the Nasdaq Capital Market in December 2022. The Board of Directors determined the 1-for-10 ratio to be appropriate in order to improve the marketability and liquidity of Checkpoint’s common stock and to remain in compliance with all of Nasdaq’s continued listing requirements.
Financial Results:
·Cash Position: As of September 30, 2022, Checkpoint’s cash and cash equivalents totaled $20.5 million, compared to $30.9 million at June 30, 2022 and $54.7 million at December 31, 2021, a decrease of $10.4 million for the quarter and a decrease of $34.2 million for the first nine months of 2022.
·R&D Expenses: Research and development expenses for the third quarter of 2022 were $8.9 million, compared to $9.4 million for the third quarter of 2021, a decrease of $0.5 million. Research and development expenses for the third quarter of 2022 included $0.3 million of non-cash stock expenses, compared to $0.2 million for the third quarter of 2021.
·G&A Expenses: General and administrative expenses for the third quarter of 2022 were $1.8 million, compared to $1.9 million for the third quarter of 2021, a decrease of $0.1 million. General and administrative expenses for the third quarter of 2022 included $0.5 million of non-cash stock expenses, compared to $0.6 million for the third quarter of 2021.
·Net Loss: Net loss attributable to common stockholders for the third quarter of 2022 was $10.6 million, or $0.12 per share, compared to a net loss of $11.3 million, or $0.14 per share, in the third quarter of 2021. Net loss for the third quarters of 2022 and 2021 both included $0.8 million of non-cash stock expenses.