On November 13, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the third quarter ended September 30, 2023, and recent corporate highlights (Press release, Checkpoint Therapeutics, NOV 13, 2023, View Source [SID1234637533]).

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"The January 3, 2024, action date for our Biologics License Application ("BLA") for cosibelimab is fast-approaching, and we continue to work closely with the U.S. Food and Drug Administration ("FDA") in completing their review," said James Oliviero, President and Chief Executive Officer of Checkpoint. "During the third quarter, pivotal trial results for cosibelimab in metastatic cutaneous squamous cell carcinoma ("cSCC") were published in the peer-reviewed Journal for ImmunoTherapy of Cancer, which further supports the efficacy and safety of cosibelimab. We also reported longer-term data from our pivotal trials in both locally advanced and metastatic cSCC that demonstrate a deepening of response over time with substantially higher complete response rates. We firmly believe that cosibelimab’s clinical profile, which includes a unique dual mechanism of action and favorable safety profile, should position the product, upon its potential launch next year, as the preferred immunotherapy of oncologists, particularly for the large number of difficult-to-treat cSCC patients who continue to suffer poor outcomes with currently available treatments."

Recent Corporate Highlights:

Checkpoint submitted a BLA to the FDA seeking approval of cosibelimab in January 2023. In March 2023, Checkpoint announced the FDA accepted the BLA filing for cosibelimab and set a Prescription Drug User Fee Act ("PDUFA") goal date of January 3, 2024. The FDA has indicated that an advisory committee meeting to discuss the application is not planned.
In July 2023, Checkpoint announced new, longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cSCC. These results demonstrate a deepening of response with cosibelimab treatment over time, resulting in substantially higher complete response rates than previously reported. Furthermore, responses continue to remain durable over time.
Also in July 2023, Checkpoint completed a registered direct offering priced at-the-market under Nasdaq rules for total gross proceeds of $10 million.
In October 2023, Checkpoint announced the exercise of previously issued warrants for $11.13 million in gross proceeds.
Also in October 2023, Checkpoint announced the publication of results from the multicenter, multiregional, pivotal trial evaluating cosibelimab in patients with metastatic cSCC in the Journal for ImmunoTherapy of Cancer (JITC), the peer-reviewed, online journal of the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). The paper, entitled, "Efficacy and Safety of Cosibelimab, an Anti–PD-L1 Antibody, in Metastatic Cutaneous Squamous Cell Carcinoma" (doi:10.1136/jitc-2023-007637), describes safety and efficacy results from 78 patients with metastatic cSCC enrolled at clinical sites in eight countries.
Financial Results:

Cash Position: As of September 30, 2023, Checkpoint’s cash and cash equivalents totaled $1.8 million, compared to $7.4 million at June 30, 2023 and $12.1 million at December 31, 2022, a decrease of $5.6 million for the quarter and a decrease of $10.3 million for the first nine months of 2023. Subsequent to the end of the third quarter, Checkpoint raised approximately $11.13 million of gross proceeds from the exercise of previously issued warrants.
R&D Expenses: Research and development expenses for the third quarter of 2023 were $5.5 million, compared to $8.9 million for the third quarter of 2022, a decrease of $3.4 million. Research and development expenses for the third quarters of 2023 and 2022 both included $0.3 million of non-cash stock expenses.
G&A Expenses: General and administrative expenses for the third quarter of 2023 were $2.2 million, compared to $1.8 million for the third quarter of 2022, an increase of $0.4 million. General and administrative expenses for the third quarter of 2023 included $0.6 million of non-cash stock expenses, compared to $0.5 million for the third quarter of 2022.
Net Loss: Net loss attributable to common stockholders for the third quarter of 2023 was $5.7 million, or $0.29 per share, compared to a net loss of $10.6 million, or $1.20 per share, in the third quarter of 2022. Net loss for the third quarter of 2023 included $0.9 million of non-cash stock expenses, compared to $0.8 million for the third quarter of 2022.