On August 5, 2021 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the second quarter ended June 30, 2021 (Press release, Checkpoint Therapeutics, AUG 5, 2021, View Source [SID1234585895]).
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James F. Oliviero, President and Chief Executive Officer of Checkpoint, stated, "In the second quarter of 2021, we were pleased to announce the completion of enrollment in our pivotal cohort of patients with metastatic cutaneous squamous cell carcinoma ("cSCC") in our ongoing registration-enabling clinical trial for cosibelimab, our potential best-in-class anti-PD-L1 antibody product candidate, and continue to expect to report top-line data in the fourth quarter of this year. Upon a successful outcome, Checkpoint intends to submit a Biologics License Application ("BLA") for cosibelimab in 2022, followed shortly thereafter by a Marketing Authorization Application submission in Europe. With a potential favorable safety profile and a plan to commercialize at a substantially lower price than currently available therapies in this drug class, we believe cosibelimab could be a disruptive product in the $25 billion and growing PD-(L)1 market."
Mr. Oliviero continued, "Additionally, during the second quarter, we had productive interactions with the FDA regarding our development program for olafertinib (formerly CK-101), our third-generation epidermal growth factor receptor ("EGFR") inhibitor being evaluated by our partner in an ongoing double-blind, randomized Phase 3 study in China. We intend to utilize the Phase 3 study, if successful, to support a New Drug Application ("NDA") submission for olafertinib as a potential first-line treatment for patients with non-small cell lung cancer whose tumors have certain types of EGFR mutations."
Financial Results:
Cash Position: As of June 30, 2021, Checkpoint’s cash and cash equivalents totaled $65.1 million, compared to $60.0 million at March 31, 2021 and $40.8 million at December 31, 2020, an increase of $5.1 million for the quarter and an increase of $24.3 million for the first half of 2021.
R&D Expenses: Research and development expenses for the second quarter of 2021 were $7.2 million, compared to $3.0 million for the second quarter of 2020, an increase of $4.2 million. The increase in research and development expense is primarily attributable to an increase in clinical trial and manufacturing related expenses for cosibelimab. Research and development expenses for the second quarters of 2021 and 2020 each included $0.2 million of non-cash stock expenses.
G&A Expenses: General and administrative expenses for the second quarter of 2021 were $2.1 million, compared to $1.7 million for the second quarter of 2020, an increase of $0.4 million. General and administrative expenses for the second quarter of 2021 included $0.9 million of non-cash stock expenses, compared to $0.7 million for the second quarter of 2020.
Net Loss: Net loss attributable to common stockholders for the second quarter of 2021 was $9.1 million, or $0.12 per share, compared to a net loss of $4.6 million, or $0.09 per share, in the second quarter of 2020. Net loss for the second quarter of 2021 included $1.0 million of non-cash stock expenses, compared to $0.8 million for the second quarter of 2020.