On March 9, 2021 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the full-year ended December 31, 2020 and recent corporate highlights (Press release, Checkpoint Therapeutics, MAR 9, 2021, View Source [SID1234576306]).
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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We are very pleased with our momentum throughout 2020, solidifying the registration path for cosibelimab in metastatic cutaneous squamous cell carcinoma ("mCSCC"), as well as announcing positive interim data from our pivotal Phase 1 program. Checkpoint’s registration-enabling study in mCSCC is approximately 90% enrolled, with full enrollment anticipated shortly. We remain on track to report full top-line results in the second half of 2021. With a potentially favorable safety profile and plan to commercialize at a lower net price, we believe cosibelimab, if approved, has the potential to be a market disruptive product in the $25 billion and growing PD-(L)1 class. We look forward to a transformative year as we continue our progress towards our first BLA submission with the U.S. Food and Drug Administration ("FDA") for cosibelimab in 2022."
2020 and Recent Corporate Highlights:
In January 2020, Checkpoint announced confirmation of the registration path for cosibelimab in mCSCC. FDA feedback supports the plan to submit a BLA based on data from the ongoing Phase 1 clinical trial.
In April 2020, Checkpoint announced that the U.S. Patent and Trademark Office issued a composition of matter patent for cosibelimab. U.S. Patent No. 10,590,199 specifically covers the antibody, cosibelimab, or a fragment thereof, providing protection through at least May 2038, exclusive of any additional patent-term extensions that might become available.
In September 2020, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, Checkpoint announced updated positive interim results from the ongoing global, open-label, multicohort, Phase 1 clinical trial of cosibelimab in patients with advanced cancers, including the registration-enabling cohort of patients with mCSCC. Cosibelimab demonstrated a 51.4% objective response rate ("ORR") and 13.5% complete response rate, which was nearly double the complete response rate observed at the time of the previous analysis.
Also in September 2020, Checkpoint closed on gross total proceeds of approximately $20.5 million in an underwritten public offering of its common stock, before deducting underwriting discounts and commissions and other offering-related expenses.
In November 2020, Checkpoint’s collaboration partner in Asia for CK-101, Neupharma Inc., initiated a Phase 3, registration-enabling study of CK-101 in first-line, EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer ("NSCLC"). Checkpoint plans to meet with the FDA to discuss the ongoing Phase 3 study design and its potential use, upon a successful study, to support a new drug application submission in the United States.
Also in November 2020, Checkpoint announced the expansion of a long-term manufacturing partnership for cosibelimab with Samsung Biologics. Building upon an existing contract manufacturing agreement entered into in 2017, Samsung Biologics will provide additional commercial-scale drug substance manufacturing for cosibelimab.
Also in November 2020, Checkpoint announced updated interim results from the ongoing global, open-label, multicohort Phase 1 clinical trial of cosibelimab in patients with advanced cancers, including a cohort of patients with previously untreated high PD-L1 expressing advanced NSCLC. The updated interim results were presented in a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting held virtually. Cosibelimab demonstrated a 44.0% ORR and 10.3-month median progression-free survival in the NSCLC cohort. A Phase 3 registration-enabling trial is planned in first-line metastatic NSCLC.
In March 2021, Checkpoint announced the formation of a Scientific Advisory Board comprised of industry thought leaders. Members include Wayne A. Marasco, M.D., Ph.D., F. Stephen Hodi, Jr., M.D., Bruce E. Johnson, M.D., David Miller, M.D., Ph.D., and Emily Ruiz, M.D., M.P.H.
Financial Results:
Cash Position: As of December 31, 2020, Checkpoint’s cash and cash equivalents totaled $40.8 million, compared to $26.1 million at December 31, 2019, an increase of $14.7 million. Cash and cash equivalents as of December 31, 2020 does not include approximately $12.0 million of net proceeds from the utilization of the Company’s At-the-Market Issuance Sales Agreement during the first quarter of 2021 at an average price of $3.88.
R&D Expenses: Research and development expenses for the year ended December 31, 2020, were $16.4 million, compared to $19.3 million for the year ended December 31, 2019, a decrease of $2.9 million. Research and development expenses for the year ended December 31, 2020 included $5.2 million of non-cash stock expenses, compared to $3.2 million in non-cash stock expenses for the year ended December 31, 2019.
G&A Expenses: General and administrative expenses for the year ended December 31, 2020 were $7.9 million, compared to $7.2 million for the year ended December 31, 2019, an increase of $0.7 million. General and administrative expenses for the year ended December 31, 2020 included $3.1 million of non-cash stock expenses, compared to $3.2 million in non-cash stock expenses for the year ended December 31, 2019.
Net Loss: Net loss attributable to common stockholders for the year ended December 31, 2020 was $23.1 million, or $0.41 per share, compared to a net loss of $24.7 million, or $0.70 per share, for the year ended December 31, 2019.