On March 26, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), reported financial results for the fourth quarter and fiscal year ended December 31, 2018 (Press release, Onconova, MAR 26, 2019, View Source [SID1234534635]).
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"This year was a period of important progress for Onconova, as we advanced our clinical pipeline, strengthened our balance sheet and senior leadership team, advanced our business development activities and expanded our intellectual property estate," said Steven M. Fruchtman, M.D., President and Chief Executive Officer. "As we move through 2019, we anticipate continued progress across the Company, including recruiting for our Phase 3 IV rigosertib trial in second-line higher-risk MDS (HR-MDS) patients and advancing oral rigosertib in combination with azacitidine toward a pivotal phase 3 trial in first-line HR-MDS patients. In addition, we have surpassed the 75% accrual figure and anticipate completion of recruitment to the pivotal Phase 3 INSPIRE trial in the second half of 2019. We anticipate reporting top-line data following full enrollment and reaching 288 death events."
2018 and Recent Highlights
Executed succession plan by promoting Steven M. Fruchtman, M.D., who previously served as Chief Medical Officer, to President and Chief Executive Officer upon the transition of Ramesh Kumar, Ph.D., to an advisory role
Strengthened the senior leadership team with the appointment of Richard Woodman, M.D., as Chief Medical Officer and Senior Vice President of Research and Development; and Avi Oler, J.D., M.B.A., as Vice President, Corporate Development and General Counsel
Achieved greater than 75% enrollment in the INSPIRE study, and enrollment is expected to be completed in 2019
Opening of new geographical areas to expedite completion of enrollment in the INSPIRE study
A new patent was issued covering oral and IV formulations of rigosertib by the U.S. Patent and Trademark Office extending the Company’s patent for rigosertib to 2037
Hosted a well-attended Key Opinion Leader Breakfast on February 7, 2019, focused on rigosertib development and earlier-stage programs
Oral Rigosertib in Combination with Azacitidine for First-Line HR MDS Trial Progress and Near-Term Milestones
Reported promising efficacy and acceptable safety profile from the Phase 2 study of a higher dose of oral rigosertib in combination with azacitidine (Vidaza) in patients with HR-MDS at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2018
Overall response rate of 90% reported in Onconova’s multi-institutional Phase 2 study in hypomethylating agent (HMA) naïve patients demonstrating a complete remission rate of 34%
Submitted a Special Protocol Assessment (SPA) to the FDA for a Phase 3 Trial of oral rigosertib in combination with azacitidine (Vidaza) for treatment of first-line HR-MDS, and are in discussions with the FDA to finalize the protocol
Business Development Progress for Rigosertib and Pipeline Products
Entered into a license agreement with Pint Pharma to commercialize rigosertib in Latin America including an up to $2.5 million investment by Pint Pharma and up to $42.75 million in regulatory and sales milestones
ON 123300, a first-in-class dual inhibitor of CDK4/6 + ARK5 with the potential to treat a variety of cancers, is advancing toward clinical development in partnership with HanX Biopharmaceuticals, Onconova’s greater China collaborator. HanX has begun manufacturing the compound and initiated toxicology studies to support an IND filing in the U.S., anticipated in the first half of 2019
Collaboration ongoing with preclinical studies of rigosertib for pediatric cancer associated RASopathies
Scheduled scientific presentations on rigosertib development and clinical trials at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, MDS Symposium in Copenhagen, European Hematology Association (EHA) (Free EHA Whitepaper) Congress, and American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Discussions with potential partners are ongoing
Year End 2018 Financial Results
Cash and cash equivalents as of December 31, 2018, totaled $17.0 million, compared to $4.0 million as of December 31, 2017. Based on current projections, the Company expects that cash and cash equivalents will be sufficient to fund ongoing trials and operations into the fourth quarter of 2019.
Net loss was $20.4 million for the year ended December 31, 2018, compared to $24.1 million for the year ended December 31, 2017, primarily due to cost controls resulting in lower operating expenses and improved revenue in 2018 from collaboration agreements executed during the first half of 2018. Research and development expenses were $16.9 million for the year ended December 31, 2018, and $19.1 million for the comparable period in 2017. General and administrative expenses were $7.6 million for the year ended December 31, 2018, and $7.4 million for the comparable period in 2017.
Conference Call and Webcast Information
The Company will host a conference call today, March 26, at 9 a.m. Eastern Time, to provide a corporate update and discuss year-end 2018 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: 1878978. The call will also be webcast live. Please click here to access the webcast. A replay will be available following the live webcast.
About Myelodysplastic Syndromes
Myelodysplastic syndromes (MDS) are conditions that can occur when the blood-forming cells in the bone marrow become dysfunctional and thus produce an inadequate number of circulating blood cells. It is frequently associated with the presence of blasts or leukemic cells in the marrow. This leads to low numbers of one or more types of circulating blood cells, and to the need for blood transfusions. In MDS, some of the cells in the bone marrow are abnormal (dysplastic) and may have genetic abnormalities associated with them. Different cell types can be affected, although the most common finding in MDS is a shortage of red blood cells (anemia). Patients with higher-risk MDS may progress to the development of acute leukemia.