Friday, August 11, 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 a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications. Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Incremental Progress Reported During 2Q23. Onconova reported a 2Q23 loss of $4.3 million or $(0.20) per share. R&D expense of $2.5 million was lower than our estimate of $4.5 million, attributed to previous completion of clinical trial start-up costs. We expect clinical costs to rise in coming quarters as patients are accrued and have adjusted our quarterly estimates. We now expect the $29.7 million cash balance to last through 2Q24.
Narazaciclib Makes Progress In Endometrial Cancer. A Phase 1/2 clinical trial testing the combination of narazaciclib with letrozole (Femara, from Novartis) in LGEEC (low grade endometrioid endometrial cancer) began treating patients in 1Q23. Onconova plans to announce results in 4Q23 including safety, pharmacokinetics, and a recommended Phase 2 dose. The Phase 2 trial is planned for 1H24 as a randomized trial against standard therapy.
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