On August 15, 2016 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported a corporate update and reported financial results for the second quarter ended June 30, 2016 (Press release, Onconova, AUG 15, 2016, View Source [SID:1234514563]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are encouraged by the progress of our global Phase 3 trial of our lead product candidate, rigosertib, for patients with myelodysplastic syndromes (MDS). The INSPIRE trial is actively enrolling patients in the U.S., Europe and Japan, and we have recently opened trial sites in Israel and Australia, bringing us more than two-thirds of the way to our target of approximately 135 sites worldwide. The enrollment of patients in Japan by our Japan/Korea partner, SymBio Pharmaceuticals, is further accelerating this important pivotal trial," said Ramesh Kumar, Ph.D., President and CEO of Onconova. "As a result of the completion of our oversubscribed rights offering in July, we believe we are positioned to deliver multiple key milestones in 2016 and 2017, including opening additional INSPIRE trial sites, pre-planned interim analysis and enrollment of approximately 225 patients. Finally, we have initiated discussions with U.S. and European regulatory authorities towards formal End-of-Phase 2 meetings to define the pathway forward for further development of oral rigosertib. We intend to provide an update on these discussions later this year."
Recent Business Highlights:
Completion of $17.4 Million Oversubscribed Financing
On July 29, 2016, Onconova closed its oversubscribed rights offering. Although the number of units able to be sold was capped at a maximum of 4,256,186 units (or approximately $17.4 million in gross proceeds), there was a total demand for approximately 4.9 million units in the rights offering.
Overall, 4,256,186 units consisting of a total of 3,599,786 shares of common stock, pre-funded warrants to purchase an additional 656,400 shares of common stock, and 3,192,022 tradable warrants were issued in this offering.
Including the net proceeds from the rights offering of approximately $15.8 million, Onconova had cash and cash equivalents of approximately $27.6 million at July 31, 2016.
Progress in INSPIRE Pivotal Trial of Rigosertib in Higher-risk MDS (HR-MDS)
The global INSPIRE trial is now enrolling patients in the United States, Europe and Japan. As of July 31, 2016, 103 sites, including 27 in the U.S., were open and recruiting patients. The first patient in Japan was enrolled in the trial in July by our partner, SymBio Pharmaceuticals, Inc.
Progress in Oral Rigosertib Combination with Azacitidine
Updated results from the Phase 2 trial 09-08 were presented in June 2016 at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper). Notably, the interim overall response rate was 77% (23 of 30 patients) among evaluable first- or second-line HR-MDS patients treated with oral rigosertib in combination with azacitidine. This trial is now fully enrolled and End-of-Phase 2 meetings to discuss the next stage of development with regulatory authorities in the U.S. and Europe are expected to occur in the second half of 2016.
Upcoming Events
Enrollment of patients in Israel, Australia and Canada for INSPIRE trial: 3Q2016
Key Opinion Leader investor event to discuss the potential future applications of the RAS-directed Mechanism of Action in oncology and for rigosertib: 3Q2016
End-of-Phase 2 meeting with FDA and European authorities to discuss trial results and future development plan for oral rigosertib in combination with azacitidine: 2H2016
Second Quarter 2016 Financial Results
Cash, cash equivalents, and marketable securities as of June 30, 2016 totaled $12.8 million, compared to $19.8 million as of December 31, 2015.
Total net revenue was $2.2 million for the second quarter of 2016 and $3.7 million for the six months ended June 30, 2016, compared to $0.1 million and $0.2 million, respectively, for the comparable periods in 2015.
Research and development expenses were $5.6 million for the second quarter of 2016 and $11.4 million for the six months ended June 30, 2016, compared to $6.5 million and $16.0 million, respectively, for the comparable periods in 2015.
General and administrative expenses were $2.1 million for the second quarter of 2016 and $5.3 million for the six months ended June 30, 2016, compared to $2.6 million and $5.5 million, respectively, for the comparable periods in 2015.