Friday, March 17, 2023
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China. Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Financial Results Were Close To Expectations. Onconova reported a loss for 4Q22 of $5.4 million or $(0.26) per share and a FY2022 loss of $19.0 million or $(0.91) per share. The company gave updates on its current narazaciclib and rigosertib clinical trials, two trials that are expected to begin shortly, and upcoming data milestones. On December 31, the company had $38.8 million in cash, which is expected to last through several important data announcements into 1Q24.
An Additional Cohort For Narazaciclib In Solid Tumors Is Planned. The Phase 1 dose-escalation trial testing narazaciclib has completed its fifth cohort at 200 mg/day without reaching its maximum tolerated dose (MTD). A sixth cohort testing a 240 mg dose is planned following a review by an independent data safety and monitoring board (DSMB). Based on the lower side effect levels seen to date, future narazaciclib trials will use once-daily every day for the 28-day cycles. This is a more tolerable regimen than the three other CDK4/6 drugs.
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