On March 17, 2022 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, 2021, and provided a business update (Press release, Onconova, MAR 17, 2022, View Source [SID1234610269]).

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Highlights for the fourth quarter of 2021 and recent weeks include:

The Phase 1 solid tumor trials of narazaciclib in the United States and China are ongoing with no dose-limiting toxicities observed to date. The trial in the United States is currently enrolling into its fourth dose cohort, which is evaluating a 160 mg daily dose administered orally on each day of a 28-day treatment cycle. The trial in China is enrolling into its fifth dose cohort, which is evaluating a 200 mg dose administered orally once a day on days 1-21 of a 28-day treatment cycle. A protocol amendment is being prepared to enable further dose escalation in the trial in China.
Rigosertib’s investigator-sponsored program has seen progress across multiple trials. This is highlighted by continued enrollment in the dose expansion portion of the Phase 1/2a study of oral rigosertib plus nivolumab in patients with KRAS+ non-small cell lung cancer (NSCLC). Additionally, recent single-patient data from a heavily pre-treated participant in the Phase 2 trial of rigosertib monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) showed a durable complete response without signs of metastatic disease.
The Company strengthened its team with the appointment of Adar Makovski Silverstein, Ph.D., as Director, Corporate Development.
Management Commentary

"The advancements made across our pipeline over the past months have us on track for an exciting 2022," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "We continue to be pleased with the safety findings from narazaciclib’s ongoing Phase 1 program and remain on track to identify a recommended Phase 2 dose in the second half of the year. Narazaciclib shows low nanomolar activity against kinases associated with tumor growth, metastasis, and potentially drug resistance, which differentiates it from currently approved CDK 4/6 inhibitors. We thus believe it may have broad therapeutic potential in monotherapy and combination settings, both in patients showing resistance to approved CDK 4/6 inhibitors and in indications where these agents are not currently approved. Narazaciclib’s clinical development plan is designed to test this hypothesis, and we look forward to its continued progress."

Dr. Fruchtman continued, "Beyond our lead program in narazaciclib, we also reported compelling preliminary clinical data from an investigator-sponsored study of rigosertib in RDEB-associated SCC. These data showed a sustained complete response in a patient that was unresponsive to several prior treatments. Though from a single patient, we believe these data represent a potentially powerful observation in this ultra-rare indication given its invariably fatal nature and the lack of effective therapies. Rigosertib’s additional investigator-sponsored trials have also shown strong progress, as we are on track to report updated data from the Phase 1/2a study evaluating rigosertib-nivolumab combination therapy in KRAS+ NSCLC this year, and to open a Phase 2 metastatic melanoma trial of oral rigosertib plus pembrolizumab in the first half. Looking ahead, we will continue to leverage the collaborations that form the basis of these trials to pursue rigosertib’s clinical development across multiple indications while remaining primarily focused on our lead narazaciclib program."

Full Year Financial Results

Cash and cash equivalents as of December 31, 2021, were $55.1 million, compared with $19.0 million as of December 31, 2020. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for at least two years.

Research and development expenses were $7.3 million for 2021, compared with $16.9 million for 2020. The decrease was primarily related to the Company’s focus on its Phase 1 program with narazaciclib, following the completion of the Phase 3 INSPIRE study in 2020.

General and administrative expenses were $9.4 million for 2021, compared with $8.3 million for 2020. The increase was primarily related to costs related to special and annual general meeting expenses in the 2021 period.

Net loss for 2021 was $16.2 million, or $0.96 per share on 16.8 million weighted average shares outstanding, compared with a net loss of $25.2 million, or $2.17 per share for 2020 on 11.6 million weighted average shares outstanding.

Conference Call and Webcast

Onconova will host an investment community conference call today beginning at 4:30 p.m. Eastern Time, during which management will discuss financial results for 2021, provide a business update, and answer questions. Interested parties can participate by dialing (855) 428-5741 (domestic callers) or (210) 229-8823 (international callers) and using conference ID 8097917.

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.