On November 14, 2023 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova" or "the Company"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported third quarter 2023 financial results and provided an update on recent pipeline progress (Press release, Onconova, NOV 14, 2023, View Source [SID1234637635]). Management plans to host a conference call and live webcast at 4:30 p.m. ET today to discuss these results.
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"Onconova has made excellent progress in the third quarter of 2023. Starting with our lead program, narazaciclib, a differentiated inhibitor of multiple kinases including CDK4/6, we advanced the registrational trial preparations in the first indication, for patients with low grade endometrioid endometrial cancer (LGEEC). CDK4/6 inhibitors have substantially changed the face of cancer care for the better and become a multibillion-dollar drug class. We believe narazaciclib has the potential to be differentiated by potently targeting proteins putatively involved in the resistance pathways of cancer cells that the approved agents fail to significantly inhibit," said Steve Fruchtman, M.D., President and Chief Executive Officer.
Dr. Fruchtman continued, "We are seeing clinical and biological target engagement with narazaciclib and an acceptable safety profile at therapeutic dosing levels in the Phase 1/2 program. To date, we have not seen significant neutropenia and thus remain on target to deliver narazaciclib as a daily anti-cancer drug not requiring time off to permit marrow recovery, in contrast to the most commonly prescribed CDK4/6 inhibitor. In addition, to date, narazaciclib has not caused significant diarrhea, another limitation of other CDK4/6 inhibitors. Based on this profile, we have decided to dose escalate to at least one more cohort in each of the ongoing U.S. studies, to ensure that we achieve the optimal recommended Phase 2 dose. This may extend the Phase 1/2 program into the first quarter of 2024. We believe this is very good news for the program because it underscores the potential for narazaciclib to have a differentiated safety profile and wide therapeutic index."
"From a corporate perspective, in the third quarter, we named Dr. Victor Moyo as Chief Medical Officer and Meena Arora as Vice-President, Global Medical Affairs & Research and Development, putting us on very solid footing to advance the clinical plan and regulatory strategy for narazaciclib and rigosertib. In addition, we continue to actively engage in a range of discussions related to partnering opportunities, to support the progression of our programs," continued Dr. Fruchtman. "Finally, we progressed the development of a registrational study plan for rigosertib, our cell pathway inhibitor, for the ultra-rare indication of recessive dystrophic epidermolysis bullosa-associated squamous cell carcinoma (RDEB-associated SCC). These developments were complemented by impressive medical meeting presentations on both programs by our collaborators."
Near Term Narazaciclib Milestones: Onconova intends to:
· present preclinical data at two December medical meetings: the San Antonio Breast Cancer Symposium (SABCS) and the annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper);
· continue the dose escalation segment of the Phase 1/2 program which may bring us into the first quarter of 2024;
· provide a read-out on narazaciclib’s safety and pharmacology in the first half of 2024;
· provide an update on our registrational trial-readiness over the next few quarters, including the definition of our recommended Phase 2 dose, engagement with the FDA on the pivotal trial design, and continuing to work with external clinical experts including the Gynecologic Oncology Group (GOG), and the European Network for Gynecologic Oncology Trials (ENGOT).
Achievement of these milestones will also enable us to establish a solid foundation to expand the program to include other indications such as breast cancer, ovarian cancer, and mantle cell lymphoma.
Rigosertib milestones: Onconova confirms plans to provide an update on the next steps to obtain orphan designation for rigosertib in RDEB-associated SCC and for the registrational program in the first half of 2024.
Second Quarter Financial Results
Cash and cash equivalents as of September 30, 2023, were $25.2 million, compared to $38.8 million as of December 31, 2022. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business into the third quarter of 2024.
Research and development expenses were $2.5 million for the third quarter of 2023, compared with $3.6 million for the second quarter of 2022.
General and administrative expenses were $2.7 million for the third quarter of 2023, compared with $2.1 million for the second quarter of 2022.
Net loss for the third quarter of 2023 was $4.7 million, or $0.23 per share on 21.0 million weighted average shares outstanding, compared with a net loss of $5.4 million, or $0.26 per share for the third quarter of 2022 on 20.9 million weighted average shares outstanding.
Conference Call and Webcast Information
Interested parties who wish to participate in the conference call may do so by dialing:
· (800) 715-9871 for domestic and
· (646) 307-1963 for international callers and
· Using conference ID 3238751
Those interested in listening to the conference call via the internet may do so by visiting the investors and media page on the Company’s website at www.onconova.com and clicking on the webcast link. In addition to the live webcast, a replay will be available on the Onconova website for 90 days following the call.