SAN DIEGO - Oncternal Therapeutics, Inc. (NASDAQ:ONCT), a clinical-stage biopharmaceutical company, announced today its decision to discontinue the clinical trials of two of its cancer treatment programs, ONCT-534 and ONCT-808. The company is now exploring strategic alternatives to maximize shareholder value, which may include asset sales, licensing, or business combinations.
The interim Phase 1 results for ONCT-534, a dual-action androgen receptor inhibitor aimed at treating metastatic castration-resistant cancer, did not demonstrate clinically meaningful improvements in the 20 patients across eight dosing cohorts. While the treatment was generally well-tolerated, dose-limiting toxicity was observed at the highest dose of 1200 mg.
For ONCT-808, a ROR1-targeting autologous CAR T program for aggressive B-cell lymphoma, interim analysis showed anti-tumor activity at all doses tested, including a complete metabolic response lasting eight months. However, treatment emergent adverse events typical of CAR-T therapies were reported, along with one death due to shock complications at the highest dose.
In light of these findings and the capital required for further development, Oncternal has opted to terminate the studies. The company will also reduce its workforce and cease all product development activities to conserve cash.
President and CEO James Breitmeyer, M.D., Ph.D., expressed disappointment at the early results, especially given the extensive preclinical data and the significant medical need the study aimed to address. He stated that the company will explore strategic options to advance and realize value from its pipeline, including ONCT-534, ONCT-808, zilovertamab, and ONCT-216.
Oncternal Therapeutics focuses on developing novel oncology therapies for cancers with unmet medical needs, particularly in hematological malignancies and prostate cancer. The company's approach targets biological pathways implicated in cancer progression.
The discontinuation of the trials and the strategic review follow industry practices to ensure resources are directed toward the most promising programs. This statement is based on a press release from Oncternal Therapeutics.
InvestingPro Insights
As Oncternal Therapeutics (NASDAQ:ONCT) reevaluates its strategic direction following the discontinuation of two clinical trials, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro data, the company's market capitalization stands at a modest $12.3 million. Despite challenges, analysts see a silver lining with an anticipated sales growth in the current year, a key metric reflecting potential future business performance.
InvestingPro Tips underscore the company's financial position, noting that Oncternal holds more cash than debt on its balance sheet, which could provide some stability as it navigates through this pivot in strategy. Additionally, the company's liquid assets exceed short-term obligations, suggesting a degree of financial resilience in the near term. However, analysts do not anticipate the company will be profitable this year, and the firm has not been profitable over the last twelve months, as reflected in the significant negative gross profit margin of -1385.16% for the last twelve months as of Q2 2024. This aligns with the company's decision to discontinue certain trials and conserve resources.
The stock has experienced a substantial decline over the past three to six months, with a 3-month price total return of -49.87% and a 6-month price total return of -53.83%. Despite this, Oncternal's stock has seen a slight uptick of 3.36% over the last week. Investors considering Oncternal as part of their portfolio should note that the company does not pay a dividend, which is a common characteristic of many clinical-stage biopharmaceutical companies.
For those seeking more detailed analysis, InvestingPro offers additional tips on Oncternal Therapeutics, available at: https://www.investing.com/pro/ONCT. The platform provides a comprehensive set of insights to help investors make informed decisions.
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