Welcome to our dedicated page for Checkpoint Therapeutics news (Ticker: CKPT), a resource for investors and traders seeking the latest updates and insights on Checkpoint Therapeutics stock.
Checkpoint Therapeutics, Inc., listed under the ticker CKPT, is a pioneering immuno-oncology biopharmaceutical company dedicated to the acquisition, development, and commercialization of novel treatments for patients with solid tumor cancers. Founded in 2014 and headquartered in New York, New York, the company operates as a subsidiary of Fortress Biotech, Inc.
Checkpoint Therapeutics focuses on developing non-chemotherapy, immune-enhanced combination treatments. One of its leading product candidates is CK-101, currently in phase I clinical trials, aimed at treating epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer. Another significant candidate is Cosibelimab, a programmed death ligand-1 (PD-L1) inhibitor in phase I trials for selected recurrent or metastatic cancers.
In addition to these, Checkpoint Therapeutics is working on CK-103, a small molecule inhibitor targeting BET bromodomains, and CK-302, a human agonistic antibody designed for oncology indications. The company has also developed a strong portfolio of antibodies focusing on PD-L1, GITR, and CAIX targets.
Checkpoint Therapeutics collaborates with TG Therapeutics, Inc. to develop and commercialize specific assets in hematological malignancies. This partnership underscores the company's commitment to advancing cancer therapies through strategic alliances.
Checkpoint Therapeutics' robust pipeline, innovative approaches to cancer treatment, and strategic collaborations make it a significant player in the biopharmaceutical industry. Investors and stakeholders can look forward to the company's continuous advancements and contributions to oncology.
Checkpoint Therapeutics (CKPT) announced the FDA accepted its Biologics License Application (BLA) for cosibelimab, targeting metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC), with a PDUFA goal date of January 3, 2024. The potential U.S. market opportunity is valued at $1.6 billion. Checkpoint reported a net loss of $62.6 million for the year ending December 31, 2022, compared to a loss of $56.7 million in 2021.
Expenses rose slightly, with R&D expenses at $49.8 million and G&A expenses at $8.7 million for the same period. Cash reserves decreased to $12.1 million from $54.7 million, though a fresh offering in February 2023 raised an additional $7.5 million.
Checkpoint Therapeutics has announced that the FDA accepted its Biologics License Application (BLA) for cosibelimab, an anti-PD-L1 therapy for patients with metastatic and locally advanced cutaneous squamous cell carcinoma (cSCC) not eligible for surgery. The PDUFA goal date is set for January 3, 2024. The FDA has identified no filing issues and does not plan to hold an advisory committee meeting. Cosibelimab shows promising clinical trial results, achieving a 47.4% confirmed objective response rate in metastatic cSCC and 54.8% in locally advanced cSCC. This potential treatment aims to address the significant unmet needs in cSCC management.
Checkpoint Therapeutics, Inc. (Nasdaq: CKPT) announced the sale of 1,428,572 shares of common stock at $5.25 each, raising approximately $7.5 million in a registered direct offering. Concurrently, Series A and Series B warrants will be issued for the same amount, exercisable at $5.00 per share for five years and eighteen months, respectively. The funding aims to support working capital and pre-commercial activities for cosibelimab, an anti-PD-L1 antibody. The offering is expected to close by February 23, 2023, pending customary conditions. H.C. Wainwright & Co. is the exclusive placement agent for this transaction.
Checkpoint Therapeutics (Nasdaq: CKPT) announced that CEO James Oliviero will participate in a fireside chat at B. Riley Securities’ 3rd Annual Oncology Conference on January 18, 2023, at 11:00 a.m. EST. This event will provide insights into Checkpoint's ongoing clinical developments, including its lead candidate, cosibelimab, an anti-PD-L1 antibody targeting solid tumors. Cosibelimab is currently in a Phase 1 trial for recurrent or metastatic cancers, particularly focusing on cutaneous squamous cell carcinoma. The company submitted a Biologics License Application in January 2023, following positive interim results.
Checkpoint Therapeutics submitted a Biologics License Application (BLA) to the FDA for its anti-PD-L1 antibody, cosibelimab, targeting metastatic and locally advanced cutaneous squamous cell carcinoma (cSCC). This BLA marks a significant milestone for the company, transitioning from a development stage to potential commercialization. Cosibelimab demonstrated promising clinical results, achieving a 47.4% objective response rate in metastatic cSCC and 54.8% in locally advanced cases. Approximately 40,000 advanced cSCC cases and 15,000 deaths occur annually in the U.S., highlighting the need for effective treatment options.
Checkpoint Therapeutics (CKPT) announced a definitive agreement to sell 1,734,105 shares of common stock and warrants for $4.325 per share in a registered direct offering, expected to yield approximately $7.5 million. The proceeds will fund working capital and the Biologics License Application for cosibelimab. The Series A and B warrants have an exercise price of $4.075, expiring in five years and eighteen months, respectively. H.C. Wainwright & Co. is the exclusive placement agent for this offering.
Checkpoint Therapeutics (Nasdaq: CKPT) announced a 1-for-10 reverse stock split effective December 6, 2022. The split aims to enhance the marketability and liquidity of its shares and ensure compliance with Nasdaq's listing requirements. Approved by the Board and over 58% of stockholders, the split reduces outstanding shares from approximately 93 million to 9.3 million. All stockholders will receive proportional cash payments for fractional shares, with no action needed for those in book-entry form. The company continues to focus on developing new treatments for solid tumor cancers.
Checkpoint Therapeutics (CKPT) announced its Q3 2022 financial results and corporate updates. The company completed two pre-BLA meetings with the FDA in July 2022, paving the way for a BLA submission scheduled for January 2023 for cutaneous squamous cell carcinoma indications. As of September 30, 2022, Checkpoint's cash and cash equivalents stood at $20.5 million, down from $30.9 million in Q2 2022. The net loss narrowed to $10.6 million, or $0.12 per share, from $11.3 million, or $0.14 per share, year-over-year.
Checkpoint Therapeutics (NASDAQ: CKPT) announced that CEO James Oliviero will participate in two investor conferences. The first is the H.C. Wainwright 24th Annual Global Investment Conference on September 13, 2022, at 8:30 AM ET, which will include a corporate update and a webcast available for 30 days post-event. The second conference, Lake Street’s 6th Annual Best Ideas Growth Conference, is on September 14, 2022, featuring one-on-one meetings only. Checkpoint is focused on developing innovative cancer treatments, including cosibelimab and olafertinib.
Checkpoint Therapeutics reported its second-quarter financial results on August 12, 2022, highlighting key advancements in the clinical development of cosibelimab for cutaneous squamous cell carcinoma (cSCC). Interim results from a pivotal trial showed a confirmed objective response rate of 54.8%. They successfully held pre-BLA meetings with the FDA, paving the way for a BLA submission for both metastatic and locally advanced cSCC by late 2022. However, the company faced a net loss of $14.1 million for the quarter, with cash reserves declining to $30.9 million.
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