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. (CKPT) generates frequent news as a commercial-stage immunotherapy and targeted oncology company focused on solid tumor cancers. Company updates center on its FDA-approved product UNLOXCYT™ (cosibelimab-ipdl) for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or curative radiation, as well as on its investigational EGFR inhibitor olafertinib (formerly CK-101).
News items commonly include regulatory milestones such as FDA acceptance and review of the Biologics License Application (BLA) for cosibelimab, issuance of a complete response letter related to a third-party contract manufacturing organization, BLA resubmission, and eventual FDA approval of UNLOXCYT. Checkpoint also reports on clinical data, including longer-term results from its pivotal cosibelimab trial in locally advanced and metastatic cSCC presented at major oncology meetings.
Investors following CKPT can also expect corporate and financial announcements, such as quarterly and full-year financial results, registered direct offerings and warrant exercises, and cash position updates. Strategic developments feature prominently, including the announced Agreement and Plan of Merger with Sun Pharmaceutical Industries, Inc., under which Checkpoint would become a wholly owned subsidiary of Sun Pharma if closing conditions are satisfied.
Additional news coverage highlights scientific and business collaborations, for example Checkpoint’s collaboration with GC Cell to explore the combined therapeutic potential of cosibelimab with Immuncell-LC, an autologous Cytokine Induced Killer T cell therapy. Conference presentations, such as corporate overviews at investor conferences, also appear in the company’s news flow. For investors and observers interested in immuno-oncology, PD-L1–targeting therapies, and EGFR-driven lung cancer research, the CKPT news page offers an ongoing view into Checkpoint’s regulatory, clinical, financial and strategic developments.
Checkpoint Therapeutics (NASDAQ: CKPT) reported its Q1 2021 financial results, highlighting advancements in drug development and a strengthened cash position. Cash and cash equivalents increased to $60 million, up from $40.8 million at year-end 2020. R&D expenses rose to $4.2 million, while G&A expenses climbed to $2.4 million. The net loss for Q1 2021 was $6.5 million, or $0.09 per share, compared to a loss of $3.3 million, or $0.06 per share, in Q1 2020. Enrollment in a pivotal study for cosibelimab is nearing completion, with results expected by year-end.
Checkpoint Therapeutics (NASDAQ: CKPT) reported its 2020 financial results, highlighting a net loss of $23.1 million, down from $24.7 million in 2019. As of December 31, 2020, the company had $40.8 million in cash, up from $26.1 million a year prior. Significant progress was made on cosibelimab, with a 90% enrollment in its registration-enabling study for metastatic cutaneous squamous cell carcinoma (mCSCC) and a promising objective response rate of 51.4%. The company anticipates full top-line results in Q2 2021 and aims for a BLA submission to the FDA in 2022.
Checkpoint Therapeutics (NASDAQ: CKPT) announced that CEO James Oliviero will participate in the H.C. Wainwright Global Life Sciences Virtual Conference on March 9-10, 2021. The session will be available on-demand starting March 9, 2021, at 7:00 a.m. ET on Checkpoint's website for about 30 days.
The company is focused on developing immunotherapy treatments for solid tumors, notably evaluating cosibelimab, a novel anti-PD-L1 antibody, and CK-101, a targeted EGFR inhibitor for lung cancer.
Checkpoint Therapeutics (NASDAQ: CKPT) announced the formation of an independent Scientific Advisory Board featuring leading experts in oncology. This board will collaborate with Checkpoint's leadership to advance novel cancer treatments, specifically cosibelimab for skin and lung cancers, and CK-101 for lung cancer. Notable members include prominent figures from Harvard Medical School and Dana-Farber Cancer Institute. CEO James F. Oliviero expressed confidence in their impactful contributions to the company's mission of developing life-saving cancer therapies.
Checkpoint Therapeutics (NASDAQ: CKPT) announced that CEO James Oliviero will participate in three virtual investor conferences in January 2021. The events include the 10th Annual LifeSci Partners Corporate Access Event, where one-on-one meetings will occur from January 6-14. The H.C. Wainwright Virtual BioConnect Conference will feature an on-demand presentation starting January 11. Lastly, B. Riley Securities' Virtual Oncology Investor Conference presentation is set for January 21. Webcasts for select presentations will be available for 30 days on Checkpoint's website.
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Checkpoint Therapeutics (CKPT) reported Q3 2020 financial results, highlighting positive interim outcomes from its clinical trial of cosibelimab for metastatic cutaneous squamous cell carcinoma (mCSCC). The company aims to complete enrollment for this trial by early 2021 and expects to release top-line results later in the year. Checkpoint expanded its cash runway with a $20.5 million financing, increasing cash reserves to $42 million. R&D expenses decreased to $2.5 million, while net loss narrowed to $4.9 million, or $0.09 per share, compared to the previous year's loss.
Samsung Biologics and Checkpoint Therapeutics have expanded their manufacturing partnership for the anti-PD-L1 antibody, cosibelimab, originally established in 2017. Under the new agreement, commercial-scale drug substance manufacturing will commence at Samsung's Plant 1 in 2021. This partnership aims to support Checkpoint's pivotal clinical trials and potential regulatory approvals for cosibelimab, which targets metastatic cutaneous squamous cell carcinoma. Checkpoint plans to release pivotal trial topline results by mid-2021.
Checkpoint Therapeutics (NASDAQ: CKPT) announced an underwriting agreement with H.C. Wainwright & Co. to sell 7,142,857 shares of common stock at $2.80 per share, expecting gross proceeds of $20 million. The offering's closing is anticipated around September 22, 2020, pending customary conditions. Additionally, the underwriter has a 30-day option to purchase up to 1,071,428 additional shares. Funds from the offering will support development activities for cosibelimab and other corporate needs.
Checkpoint Therapeutics (CKPT) announced interim results for cosibelimab, an anti-PD-L1 antibody targeting metastatic cutaneous squamous cell carcinoma (mCSCC). The data showed a 51.4% objective response rate (ORR) and 13.5% complete response rate, exceeding previous anti-PD-1 therapies. A favorable safety profile was noted, with lower severe adverse events. The company aims for market-disruptive pricing in the estimated $25 billion PD-(L)1 market. Full results are expected mid-2021, emphasizing the potential for cosibelimab to provide cost-effective treatment options.