On March 16, 2023 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported financial results for the twelve months ended December 31, 2022, and provided a business update (Press release, Onconova, MAR 16, 2023, View Source [SID1234628941]).
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Highlights for the fourth quarter of 2022 and recent weeks include:
· Based upon encouraging safety findings from its ongoing Phase 1 program, Onconova intends to administer narazaciclib orally with a continuous daily dosing schedule in upcoming clinical trials. Results from the Phase 1 solid tumor trial evaluating a continuous daily dosing regimen of narazaciclib showed that the maximum tolerated dose was not reached through the fifth dose escalation cohort. The Phase 1 trial will advance to its sixth dose escalation cohort, which will evaluate a dose of 240 mg orally on a continuous daily schedule.
· The Phase 1/2a trial of narazaciclib combined with letrozole in recurrent metastatic low-grade endometrioid endometrial cancer (LGEEC) is expected to open for enrollment in the first quarter of 2023. The trial remains on track for a preliminary data readout from its Phase 1 portion in the fourth quarter of 2023.
· Two abstracts describing the results of preclinical studies of narazaciclib were recently accepted for poster presentations at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The abstracts, which are available on the AACR (Free AACR Whitepaper) website, are titled "Differential targets engaged by narazaciclib in comparison to the approved CDK4/6 inhibitors contribute to enhanced inhibition of tumor cell growth" and "Synergistic activity of the CDK4/6 antagonist narazaciclib (ON123300) with irreversible BTK inhibition in ibrutinib-resistant mantle cell lymphoma."
· The investigator-sponsored Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) continues to progress and remains open for enrollment. The second of two evaluable participants in the program recently achieved a complete clinical response of all cancerous skin lesions following four treatment cycles of oral rigosertib. The program’s first evaluable participant previously achieved a complete response. Both participants remain on therapy and have maintained their response to therapy to-date. Onconova intends to review the program’s initial data with regulators to gain insight on the optimal regulatory path for rigosertib in RDEB-associated SCC, an ultra-rare and invariably fatal condition.
· Rigosertib’s additional investigator-sponsored trials also continue to progress. The Phase 1/2a trial evaluating rigosertib in combination with nivolumab in KRAS-mutated (KRAS+) non-small cell lung cancer (NSCLC) continues to enroll patients in its dose-expansion cohort, with additional data from the trial expected in the second quarter of 2023. A Phase 2 trial of rigosertib in combination with pembrolizumab in patients with checkpoint inhibitor refractory metastatic melanoma is expected to open for enrollment later this quarter.
· Data from cell-based and in vitro assays characterizing rigosertib’s multi-faceted mechanism of action were recently featured in a poster presentation at the AACR (Free AACR Whitepaper) Targeting RAS Conference.
Management Commentary
"We recently received IRB approval at New York University Langone Health for our Phase 1/2a trial of narazaciclib plus letrozole in recurrent LGEEC, which is on track for an important preliminary readout later this year," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "Prior preclinical data as well as single arm and randomized Phase 2 clinical data provide strong proof-of-concept for narazaciclib’s mechanism of action in LGEEC and demonstrate its potential to overcome the numerous shortcomings of the CDK 4/6 inhibitors that are currently used off-label in combination with letrozole in this indication. We look forward to building on these datasets in our upcoming trial, which we believe will further highlight the advantages of narazaciclib’s differentiated kinase inhibitory profile."
Dr. Fruchtman continued, "Recent progress in rigosertib’s investigator-sponsored trials was highlighted by data from our RDEB-associated SCC program. With both of the program’s evaluable participants achieving a complete clinical response of all cancerous skin lesions with rigosertib monotherapy, we now intend to engage with regulators to identify the most expeditious path to a potential approval in this ultra-orphan indication. In addition, trials of rigosertib combined with checkpoint inhibition continue to advance, with a Phase 2 study in checkpoint-inhibitor refractory melanoma expected to open for enrollment later this quarter and additional data from a Phase 1/2a trial in KRAS-mutated NSCLC expected next quarter. Looking forward, we expect the continued progress of these investigator-sponsored trials to provide an important source of value to complement our lead narazaciclib program, which remains our primary focus."
Full Year Financial Results
Cash and cash equivalents as of December 31, 2022, were $38.8 million, compared with $55.1 million as of December 31, 2021. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations into the first quarter of 2024.
Research and development expenses were $11.4 million for 2022, compared with $7.3 million for 2021. The increase was primarily related to the narazaciclib development program and drug manufacturing.
General and administrative expenses were $8.4 million for 2022, compared with $9.4 million for 2021. The decrease was primarily related to lower costs for our annual general meeting than in the 2021 period.
Net loss for 2022 was $19.0 million, or $0.91 per share on 20.9 million weighted average shares outstanding, compared with a net loss of $16.2 million, or $0.96 per share for 2021 based on 16.8 million weighted average shares outstanding.
Conference Call and Webcast
Onconova will host an investment community conference call beginning at 4:30 p.m. Eastern Time, during which management will discuss financial results for the full year 2022, provide a business update, and answer questions. Interested parties can participate by dialing (800) 715-9871 (domestic callers) or (646) 307-1963 (international callers) and using conference ID 3097517.
A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.