WALTHAM, Mass. – Checkpoint Therapeutics , Inc. (NASDAQ:CKPT), a clinical-stage company specializing in immunotherapy and targeted oncology, recently presented updated data from its pivotal trial of cosibelimab at the European Society for Medical Oncology Congress in Barcelona. The trial focuses on the treatment of advanced cutaneous squamous cell carcinoma (cSCC), a common and potentially deadly skin cancer.
The new data indicates a deepening response over time, with objective response rates (ORRs) and complete response rates surpassing earlier observations. With 16 months of additional follow-up since the primary analysis, cosibelimab showed ORRs of 54.8% in locally advanced cSCC and 50.0% in metastatic cSCC. Notably, complete response rates reached 25.8% and 12.8% in the respective groups, and the median duration of response has not yet been reached.
In terms of safety, the treatment demonstrated a manageable profile among 192 patients, with low rates of severe immune-related adverse events (irAEs) and treatment discontinuations due to treatment-emergent adverse events (TEAEs). Only 3.6% experienced grade 3 irAEs, and there were no grade 4 or higher irAEs reported. The most common reason for treatment discontinuation, observed in 6.3% of patients, was COVID-19 related.
Checkpoint Therapeutics has set its sights on a December 28, 2024, Prescription Drug User Fee Act (PDUFA) goal date for the Biologics License Application (BLA) for cosibelimab. This follows a complete response letter from the FDA in December 2023, which cited issues from a third-party contract manufacturing organization but did not question the drug's efficacy or safety. Since then, Checkpoint has resubmitted the BLA, which was accepted by the FDA.
Cosibelimab, a fully-human monoclonal antibody, functions by inhibiting the interaction between PD-L1 and its receptors, potentially reactivating an antitumor immune response. The company believes that if approved, cosibelimab's safety profile and dual mechanisms of action could make it the preferred immunotherapy among U.S. oncologists for treating advanced cSCC.
Checkpoint Therapeutics, founded by Fortress Biotech, Inc. (NASDAQ:FBIO), remains focused on developing novel treatments for solid tumor cancers. This information is based on a press release statement from Checkpoint Therapeutics.
In other recent news, Checkpoint Therapeutics reported its second-quarter financial results, beating both firm's and consensus estimates with an earnings per share (EPS) of ($0.18). The company ended the quarter with $5.0 million in cash reserves, not including the additional $12.0 million secured from a recent offering. Checkpoint also resubmitted its Biologics License Application (BLA) for cosibelimab, a key product in its pipeline, to the FDA, which has set a goal date of December 28, 2024 for review.
H.C. Wainwright reiterated a Buy rating on the stock, expressing confidence in the potential market opportunity for cosibelimab. In addition, Checkpoint Therapeutics announced a stock sale expected to generate approximately $12 million, intended for working capital and general corporate purposes. The company also entered into a partnership with GC Cell to evaluate the combination of their cancer treatments, cosibelimab and GC Cell's Immuncell-LC.
These recent developments highlight the ongoing efforts of Checkpoint Therapeutics in the field of immunotherapy and targeted oncology. The company continues to work closely with the FDA and other partners to advance its product candidates and enhance its therapeutic arsenal.
InvestingPro Insights
Checkpoint Therapeutics, Inc. (NASDAQ:CKPT) has been navigating a challenging landscape as it progresses through clinical trials and regulatory hurdles. The company's dedication to developing innovative cancer treatments, such as cosibelimab, has been a focal point for investors and industry observers alike. As we consider the company's financial health and market position, several metrics from InvestingPro stand out.
InvestingPro Data shows a market capitalization of $103.09 million, reflecting the company's current valuation in the market. This figure is particularly relevant as it provides context for the company’s size and growth potential, especially when considering the significant revenue valuation multiple at which the stock is trading. The Price to Book (P/B) ratio, standing at -6.56 as of the last twelve months up to Q2 2024, is indicative of market sentiment and valuation, which can be a crucial factor for potential investors.
Despite the recent positive trial results, Checkpoint Therapeutics has been grappling with financial challenges. The company's revenue has seen a decline of 58.51% over the last twelve months as of Q2 2024, a metric that underscores the importance of successful product development and commercialization for the company's future. Additionally, the gross profit margin has been deeply negative at -34223.08% over the same period, reflecting the costs associated with its research and development efforts outweighing its revenue—a common scenario for clinical-stage biotech companies.
InvestingPro Tips highlight several key points for investors to consider. Checkpoint Therapeutics has experienced a significant return over the last week, with a 7.98% price total return, which may attract the attention of those looking for short-term gains. However, the company does not pay a dividend, suggesting that it is reinvesting all earnings back into the company to fund its research, which could be a positive sign for growth-focused investors.
Moreover, Checkpoint Therapeutics is identified as a niche player in the immunotherapy and targeted oncology industry. This specialization could be a double-edged sword, offering the potential for significant rewards if its treatments gain approval and market traction, but also carrying the risk inherent in a highly focused product pipeline.
For those interested in a deeper dive into the company's prospects, there are additional InvestingPro Tips available at https://www.investing.com/pro/CKPT. These tips can provide investors with a more comprehensive understanding of Checkpoint Therapeutics' position in the market and its potential for growth.
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