On March 24, 2020 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), reported financial results for the year ended December 31, 2019 and provided a corporate update (Press release, Onconova, MAR 24, 2020, View Source [SID1234555787]).
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"Following significant progress throughout 2019, our team’s immediate focus remains to advance our pivotal Phase 3 INSPIRE trial to the next milestone," said Steven M. Fruchtman, M.D., President and Chief Executive Officer. "We are excited to announce the completion of the planned enrollment of 360 patients in the INSPIRE trial in higher-risk (HR) MDS patients. INSPIRE represents one of the largest studies ever conducted in this patient population. Based on survival trends on the INSPIRE trial to date, we anticipate reporting topline survival data in the second half of 2020 and presenting the results at a medical meeting later this year. We continue to analyze deep genomic sequencing, including mutations of the Ras pathway, on these patients. Important genomic results were presented at ASH (Free ASH Whitepaper) 2019 and additional data is expected to be presented at future medical meetings."
Dr. Selina Luger, M.D., Professor of Medicine at the Hospital of the University of Pennsylvania Division of Hematology Oncology, commented, "in second line HR MDS, following progression or failure of patients to respond to hypomethylating agents, there is no standard of care and currently no health authority approved agent in the world. There is a tremendous unmet medical need for these patients. The INSPIRE trial, which has now reached full accrual, is studying the experimental agent rigosertib to determine if it can significantly prolong the survival of these patients when compared to physician’s choice of therapy. We eagerly look forward to the results of this pivotal trial."
Dr. Fruchtman continued, "We are also pleased about the progress of our plans for additional investigator-initiated studies – including the Phase 1/2a study of rigosertib plus nivolumab for the treatment of Stage IV KRAS mutated lung adenocarcinoma. We anticipate the first patient to be entered onto the trial once the COVID-19 environment improves sufficiently."
Fourth Quarter 2019 and Additional Achievements
Knight Therapeutics License for Rigosertib in Canada
Specialised Therapeutics License for Rigosertib in Australia and New Zealand
Inceptua Medicines Pre-approval Access Collaboration for Rigosertib in Selected Countries Outside the US
Re-acquired Rigosertib Rights in Greater China
Next generation CDK 4/6 + ARK5 inhibitor, ON123300, IND approved in China
Additional Milestones for Rigosertib and Pipeline Products
Clinical trial protocol progressing for a randomized Phase 2/3 study of the combination of oral rigosertib plus azacitidine
Expansion of the rigosertib investigator-initiated studies program to include KRAS mutated non-small cell lung cancer, melanoma and other RAS mutated-driven cancers
Next generation CDK 4/6 + ARK5 inhibitor, ON123300, US IND submission planned in 4Q 2020
Pivotal survival data from the INSPIRE trial expected in 2H 2020
Full Year 2019 Financial Results
Cash and cash equivalents as of December 31, 2019, totaled $22.7 million, compared to $17.0 million as of December 31, 2018. Besides the $9 million of net proceeds from the financing closed in early 2020, common stock warrant exercises since 12/31/19 have added $5.7 million to the Company’s cash balance resulting in a cash balance at February 29, 2020 of $32.6 million. Based on current projections, the Company expects that cash and cash equivalents will be sufficient to fund ongoing trials and operations into the third quarter of 2021.
Net loss was $21.5 million for the year ended December 31, 2019, compared to $20.4 million for the year ended December 31, 2018. Research and development expenses were $15.5 million for the year ended December 31, 2019 and $16.9 million for the comparable period in 2018. General and administrative expenses were $8.3 million for the year ended December 31, 2019 and $7.6 million for the comparable period in 2018.
Conference Call and Webcast Information
The Company will host a conference call today, March 24, 2020, at 4:30 p.m. Eastern Time, to provide a corporate update and discuss year-end 2019 financial results. Interested parties may access the call by dialing toll-free (855) 428-5741 from the U.S., or internationally (210) 229-8823 and using conference ID 3267259. The call will also be webcast live. Please click here to access the webcast. A replay will be available following the live webcast.