On August 14, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the second quarter ended June 30, 2023, and recent corporate highlights (Press release, Checkpoint Therapeutics, AUG 14, 2023, View Source [SID1234634358]).

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"We continue to work with the U.S. Food and Drug Administration ("FDA") toward the January 3, 2024 action date for our Biologics License Application ("BLA") for cosibelimab. Recently, our mid-cycle communication meeting with the FDA was successfully completed, and the FDA noted that no significant review issues or safety concerns have been identified in their review to date," said James Oliviero, President and Chief Executive Officer of Checkpoint.

"We are also encouraged by the recently announced longer-term data from our pivotal studies of cosibelimab in locally advanced and metastatic cutaneous squamous cell carcinoma ("cSCC"), which demonstrate a deepening of response with cosibelimab treatment over time, resulting in substantially higher complete response rates than previously reported. Specifically, complete response rates more than doubled from 10% to 23% in locally advanced cSCC and nearly doubled, from 8% to 13%, in metastatic cSCC," continued Oliviero. "We believe cosibelimab’s unique dual mechanism of action will benefit not just immunocompetent patients, but also the large number of difficult-to-treat patients with immunosuppressive conditions or taking immunosuppressive medications who are in need of more effective treatment options than available today."

"Equally important, longer-term results continue to confirm cosibelimab’s favorable safety profile, with only 2% of patients experiencing a severe immune-related adverse event ("irAE") and only 1% discontinuing treatment because of an irAE, substantially lower rates than observed with currently approved immunotherapies. We believe cosibelimab’s favorable safety profile should position the product as the preferred immunotherapy of oncologists for high-risk patients, such as those with solid organ transplants or autoimmune disease, upon its potential launch early next year," concluded Oliviero.

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. In its BLA filing acceptance letter, the FDA indicated that no potential filing review issues have been identified, and that an advisory committee meeting to discuss the application is not currently planned.
In April, May and July 2023, Checkpoint completed registered direct offerings priced at-the-market under Nasdaq rules for total gross proceeds of approximately $26.1 million.
In June 2023, Checkpoint announced that new pharmacokinetic modeling data on cosibelimab supporting the extension to an every-three-week dosing regimen were presented at the Population Approach Group Europe 2023 annual meeting. Results support the comparability of cosibelimab 800 mg every-two-week and 1200 mg every-three-week dosing regimens.
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 with the median duration of response not yet reached in either the locally advanced or metastatic cSCC group.
Financial Results:

Cash Position: As of June 30, 2023, Checkpoint’s cash and cash equivalents totaled $7.4 million, compared to $4.8 million at March 31, 2023 and $12.1 million at December 31, 2022, an increase of $2.6 million for the quarter and a decrease of $4.7 million for the first half of 2023. Subsequent to the end of the second quarter, Checkpoint raised approximately $10.0 million of gross proceeds in a registered direct offering completed in July 2023.
R&D Expenses: Research and development expenses for the second quarter of 2023 were $13.9 million, compared to $12.1 million for the second quarter of 2022, an increase of $1.8 million. Research and development expenses for the second quarter of 2023 primarily consisted of $9.9 million related to commercial manufacturing costs and inventory build for cosibelimab to support a potential 2024 launch.
G&A Expenses: General and administrative expenses for the second quarter of 2023 were $2.3 million, compared to $2.1 million for the second quarter of 2022, an increase of $0.2 million. General and administrative expenses for the second quarter of 2023 included $0.8 million of non-cash stock expenses, compared to $0.5 million for the second quarter of 2022.

Net Loss: Net loss attributable to common stockholders for the second quarter of 2023 was $16.5 million, or $1.05 per share, compared to a net loss of $14.1 million, or $1.62 per share, in the second quarter of 2022. Net loss for the second quarter of 2023 included $1.0 million of non-cash stock expenses, compared to $0.7 million for the second quarter of 2022.