On August 12, 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 quarter ended June 30, 2020, and provided a business update (Press release, Onconova, AUG 12, 2020, View Source [SID1234563510]).
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"With INSPIRE recently meeting the number of survival events required by the study’s 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 1/2a 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 Company’s Board of Directors
Nasdaq compliance regained with achievement of dollar bid price listing requirement
Recent 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) (Free EHA Whitepaper) Congress
Publication in Molecular Cell of preclinical data supporting rigosertib’s 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 leukemia
Additional 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 2/3 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 4/6 + 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 cancers
Second 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 company’s website at www.onconova.com 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.