On May 12, 2022 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the first quarter ended March 31, 2022 and recent corporate highlights (Press release, Checkpoint Therapeutics, MAY 12, 2022, View Source [SID1234614367]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "The positive topline results generated in the first quarter from our ongoing registrational trial of cosibelimab in metastatic cutaneous squamous cell carcinoma ("cSCC") laid the foundation for a potentially transformational year for our lead immunotherapy product candidate and for our company as a whole. We remain on track to submit our U.S. Biologics License Application ("BLA") for cosibelimab later this year and continue to evaluate partnership opportunities for the potential commercialization of cosibelimab in Europe and other key territories worldwide." Mr. Oliviero continued, "Our focus remains on advancing our pipeline of potentially life-saving novel oncology therapies with the goal of expanding patient access globally through a disruptive pricing strategy, beginning with the $30 billion and growing PD-(L)1 market."

Recent Corporate Highlights:

In January 2022, Checkpoint announced positive topline results from the ongoing registration-enabling clinical trial evaluating the safety and efficacy of its anti-PD-L1 antibody, cosibelimab, administered as a fixed dose of 800 mg every two weeks in patients with metastatic cSCC. The study met its primary endpoint, with cosibelimab demonstrating a confirmed objective response rate of 47.4% (95% CI: 36.0, 59.1) based on independent central review of 78 patients enrolled in the metastatic cSCC cohort using Response Evaluation Criteria in Solid Tumors version 1.1 criteria. Checkpoint intends to submit a BLA for cosibelimab in late 2022, followed by a Marketing Authorization Application submission in Europe and other territories worldwide. With a potentially favorable safety profile versus anti-PD-1 therapy and a plan to commercialize at a substantially lower price, Checkpoint believes cosibelimab has the potential to be a market disruptive product in the $30 billion and growing PD-(L)1 class.
In April 2022, Checkpoint announced that the results of its pivotal trial of cosibelimab in cSCC were selected for poster presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held at McCormick Place, in Chicago, June 3-7, 2022.
Financial Results:

Cash Position: As of March 31, 2022, Checkpoint’s cash and cash equivalents totaled $41.5 million, compared to $54.7 million at December 31, 2021, a decrease of $13.2 million.
R&D Expenses: Research and development expenses for the first quarter of 2022 were $14.7 million, compared to $4.2 million for the first quarter of 2021, an increase of $10.5 million. Research and development expenses for the first quarters of 2022 and 2021 each included $0.2 million of non-cash stock expenses.
G&A Expenses: General and administrative expenses for the first quarter of 2022 were $2.2 million, compared to $2.4 million for the first quarter of 2021, a decrease of $0.2 million. General and administrative expenses for the first quarter of 2022 included $0.7 million of non-cash stock expenses, compared to $1.2 million for the first quarter of 2021.
Net Loss: Net loss attributable to common stockholders for the first quarter of 2022 was $16.8 million, or $0.20 per share, compared to a net loss of $6.5 million, or $0.09 per share, in the first quarter of 2021. Net loss for the first quarter of 2022 included $0.9 million of non-cash stock expenses, compared to $1.4 million for the first quarter of 2021.