 INSPIRE Phase 3 trial survival events reached Topline data anticipated Q3-2020Conference call and webcast scheduled today, August 12, at 4:30 p.m. ETNEWTOWN, Pa., Aug. 12, 2020 GLOBE NEWSWIRE -- 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, today reported financial results for the quarter ended June 30, 2020, and provided a business update.With INSPIRE recently meeting the number of survival events required by the studys statistical analysis plan, we anticipate reporting topline data by the end of the current quarter, said Steven M. Fruchtman, M.D., President and Chief Executive Officer. If the data readout demonstrates a significant prolongation of survival for patients randomized to intravenous rigosertib, we believe this could represent a significant medical advancement for patients with higher-risk MDS. Following such data readout, we anticipate submitting a New Drug Application to the FDA to seek approval to commercially launch rigosertib.Second Quarter 2020 Developments and Recent Highlights Pivotal Phase 3 INSPIRE trial reached the required number of survival events for data analysis Initiation of and first patient enrollment in a Phase 12a study exploring an oral rigosertib plus nivolumab combination in KRAS lung cancer patients Applications submitted for rigosertib to participate in federally funded human studies in COVID-19 disease based on early-stage preclinical evidence of rigosertib inhibition of SARS-COV-2 replication Election of life sciences industry veteran Terri Shoemaker to the Companys Board of Directors Nasdaq compliance regained with achievement of dollar bid price listing requirementRecent Presentations and Scientific Publications Presentation of updated aggregated baseline genomic data from HMA-failure patients screened and randomized for the INSPIRE trial, in e-poster form, at the virtual 25th Annual European Hematology Association EHA Congress Publication in Molecular Cell of preclinical data supporting rigosertibs mechanism of action as a targeted anticancer agent Publication of Phase 1 results in Leukemia Research for oral rigosertib in combination with azacitidine in higher-risk HR-MDS and acute leukemiaAdditional Expected Company Milestones Announcement of topline INSPIRE results by the end of the third quarter of 2020, with data presentation at a major medical meeting later in the year FDA review of Phase 23 trial protocol of oral rigosertib plus azacitidine in hypomethylating agent HMA naïve HR-MDS Federal funding agencies review of applications for clinical trials with rigosertib in SARS-COV-2 disease Virtual presentation at the 2nd Annual RAS-Targeted Drug Development Summit September 14-16, 2020 US IND submission planned for 4Q 2020 for next generation CDK 46 ARK5 inhibitor, ON 123300, with first in-human Phase 1 trial anticipated in 1Q 2021, and Phase 1 study commencement in China planned for 2H 2020 Anticipated launch of Early Access Program with Inceptua Medicines Group in 2H 2020 Expansion of rigosertib investigator-initiated development program to encompass additional RAS-driven cancersSecond Quarter 2020 Financial Results Cash and cash equivalents as of June 30, 2020, totaled 27.2 million, compared to 22.7 million as of December 31, 2019. Exercises of common stock warrants from our financing transactions in November and December 2019 have added 9.8 million to our balance sheet since January 1, 2020, and as of August 12, 2020, we have 183,578,267 common shares outstanding. Of the 12.6 million common stock warrants which remain outstanding at August 12, 2020, 80 were in-the-money. Based on current projections, the Company expects that its cash and cash equivalents will be sufficient to fund ongoing trials and operations into the fourth quarter of 2021.Net loss was 7.4 million for the quarter ended June 30, 2020, compared to 3.6 million for the quarter ended June 30, 2019. Research and development expenses were 4.8 million for the quarter ended June 30, 2020 and 3.9 million for the comparable period in 2019. General and administrative expenses were 2.6 million for the quarter ended June 30, 2020 and 1.8 million for the comparable period in 2019.Conference Call and Webcast Information The Company will host a conference call today, August 12, 2020, at 4:30 p.m. Eastern Time. Interested parties who wish to participate in the conference call may do so by dialing 855 428-5741 for domestic and 210 229-8823 for international callers and using conference ID 2875654.To facilitate an on-time conference call start, Onconova recommends that participants dial in 15 minutes before the 4:30 p.m. ET start time.Those interested in listening to the conference call via the internet may do so by visiting the investors and media page on the companys website at 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.About Onconova Therapeutics, Inc. Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical company focused on discovering and developing novel drugs to treat cancer, with an initial focus on myelodysplastic syndromes MDS. Onconova has a pipeline of proprietary targeted agents designed to work against specific cellular pathways that are important in cancer cells. Advanced clinical trials with the Companys lead compound, rigosertib, are aimed at what the Company believes are unmet medical needs of patients with MDS. Onconova has conducted trials with additional research compounds and has a pre-clinical program with a CDK46 and ARK5 inhibitor, ON 123300.For more information, please visit 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.About Rigosertib Rigosertib, Onconovas lead candidate, is a proprietary Phase 3 small molecule. A key publication in a preclinical model reported rigosertibs ability to block cellular signaling by targeting RAS effector pathways Divakar, S.K., et al., 2016: A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling. Cell 165, 643. Onconova is currently in the clinical development stage with oral and IV rigosertib, including clinical trials studying single agent IV rigosertib in second-line higher-risk MDS patients pivotal Phase 3 INSPIRE trial and oral rigosertib plus azacitidine in HMA naive and refractory higher-risk MDS patients Phase 2. Preclinical studies with rigosertib are underway in COVID-19 as well. Patents covering oral and injectable rigosertib have been issued in the US and are expected to provide coverage until at least 2037.About the INSPIRE Phase 3 Clinical Trial The clinical trial INternational Study of Phase 3 IV RigosErtib, or INSPIRE, was finalized following guidance received from the U.S. Food and Drug Administration and European Medicines Agency. INSPIRE is a global, multi-center, randomized, controlled study to assess the efficacy and safety of IV rigosertib in higher-risk MDS HR-MDS patients who had progressed on, failed to respond to, or relapsed after previous treatment with a hypomethylating agent HMA within nine cycles over the course of one year after initiation of HMA treatment. This time frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines. Patients are randomized at a 2:1 ratio into two study arms: IV rigosertib plus Best Supportive Care versus Physicians Choice plus Best Supportive Care. The primary endpoint of INSPIRE is overall survival. The trial continued beyond the pre-specified interim analysis and is nearing its conclusion. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov NCT02562443.About IV Rigosertib The intravenous form of rigosertib has been studied in Phase 1, 2, and 3 clinical trials involving more than 1000 patients, and is currently being evaluated in a randomized Phase 3 international INSPIRE trial for patients with HR-MDS after failure of HMA therapy.About Oral Rigosertib The oral form of rigosertib was developed to provide a potentially more convenient dosage form for use where the duration of treatment may extend to multiple years. This dosage form may also support combination therapy modalities. To date, over 400 patients have been dosed with the oral formulation of rigosertib in clinical trials. Combination therapy of oral rigosertib with azacitidine, the standard of care in HR-MDS, has also been studied. Currently, oral rigosertib is being developed as a combination therapy together with azacitidine for patients with higher-risk MDS who require HMA therapy. A Phase 12 trial of the combination therapy has been fully enrolled, and the updated efficacy and safety data was presented at the ASH 2019 Annual Meeting in December 2019. 