IRVINE, Calif. - CG Oncology, Inc. (NASDAQ: CGON), a biopharmaceutical company engaged in the development of oncology therapeutics, announced the publication of its Phase 2 CORE-001 trial results in Nature Medicine, which demonstrated promising efficacy and safety for its bladder cancer treatment, cretostimogene plus pembrolizumab. The study, focusing on patients with BCG-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), reported a 54% complete response rate at the 24-month landmark, meeting the trial's primary endpoint.
The company's Chief Medical Officer, Dr. Vijay Kasturi, highlighted the significance of the findings, emphasizing the potential of cretostimogene as a non-surgical, bladder-sparing therapy. The data, also presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, showed that 95% of patients who achieved a complete response at 12 months maintained this response for an additional year. Moreover, the median duration of response has not been reached but exceeds 21 months, and progression-free survival at 24 months was 100%, with no patients advancing to muscle invasive or metastatic disease.
Treatment-related adverse events were in line with expectations and did not indicate increased toxicity when the two drugs were combined. The trial was conducted in collaboration with Merck Sharp (OTC:SHCAY) & Dohme LLC, a subsidiary of Merck & Co., Inc.
Cretostimogene has previously received FDA Fast Track and Breakthrough Therapy Designations for certain bladder cancer indications. CG Oncology anticipates final data from its Phase 3 BOND-003 trial by the end of 2024, with hopes for subsequent regulatory approval submission.
The CORE-001 study is part of a broader investigation into cretostimogene's efficacy, including a Phase 3 trial for high-risk NMIBC patients and another study in combination with nivolumab for muscle invasive bladder cancer. While the results are promising, cretostimogene is still under investigation and has not yet been approved by the FDA or any other health authority.
This report is based on a press release statement from CG Oncology.
In other recent news, CG Oncology has been the focus of a significant upgrade from Goldman Sachs, who raised their target for the company to $50 following promising clinical trial data. This upgrade was prompted by the results of the Phase 2 study of cretostimogene, CG Oncology's lead drug candidate. The study, known as BOND-003, revealed an increased probability of success in treating high-risk non-muscle invasive bladder cancer, rising from 75% to 85%.
Goldman Sachs maintains a positive outlook on CG Oncology, interpreting the data as competitive against both approved and clinical-stage products. This is supported by physician endorsements of cretostimogene at the recent American Urological Association conference, where the drug's safety profile, sustained efficacy, and unique mechanism of action were emphasized.
The firm also anticipates that the robust 12-month and duration of response findings will meet approval standards, reducing the risk of a negative outcome for the complete BOND-003 study, set to conclude later this year. Looking to the future, Goldman Sachs projects that the study results will support a regulatory filing in 2025, potentially leading to a drug approval and market launch in 2026. The estimated commercial opportunity for cretostimogene in its targeted market is approximately $2.5 billion.
InvestingPro Insights
Amidst the clinical success of its bladder cancer therapy, CG Oncology, Inc. (NASDAQ: CGON) presents a mixed financial landscape. According to InvestingPro data, CGON holds a market capitalization of approximately $2.4 billion. Despite the company's innovative strides in oncology therapeutics, it has reported a negative gross profit margin over the last twelve months as of Q1 2024, standing at -10126.34%, underscoring the costs outweighing revenue during this period. Furthermore, the company's revenue growth has been robust, with a quarterly increase of 172.68% in Q1 2024, reflecting significant market interest and potential for its therapeutic developments.
From an investment standpoint, CGON has not been profitable over the last twelve months, and it is trading at a high revenue valuation multiple. Two InvestingPro Tips that stand out include the company's solid cash position, holding more cash than debt on its balance sheet, which offers financial resilience and flexibility. Additionally, analysts anticipate sales growth in the current year, which may be buoyed by the positive clinical trial results and potential FDA approvals on the horizon.
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