- Following evaluation of 54 enrolled patients in the Phase 2 Trial 09-08 of oral rigosertib plus azacitidine, Onconova conducted an End-of-Phase 2 meeting during which updated results from this trial were discussed with the FDA. Based on these discussions, and guidance from the Agency, Onconova will design a randomized, controlled Phase 3 clinical trial comparing the combination of oral rigosertib plus azacitidine to azacitidine plus placebo in hypomethylating agent (HMA) naïve HR-MDS patients. This sizable population of MDS patients not previously treated with HMAs is a poorly met medical need where the front-line treatments (HMAs) are effective for only a fraction of the indicated patients. Notably, in contrast to the INSPIRE trial, where the primary efficacy endpoint was Overall Survival (OS), the new pivotal trial will employ Response Rate (RR) as the approval endpoint, permitting more rapid completion and evaluation of the study. The RR will be a composite of complete remission (CR) and partial remission (PR).
- The global Phase 3 INSPIRE trial of IV rigosertib in patients who have failed to respond to or progressed with an HMA therapy is now enrolling in the United States, Europe, Australia, and Japan. As of October 3, 2016, 157 sites were open for the INSPIRE trial to recruit patients.
- The INSPIRE trial was recently reviewed in a pre-planned first meeting of the Drug Safety Monitoring Board. Following a review of the safety data of enrolled patients, the Board recommended continuation of the trial without any modifications.
- Onconova hosted an investor event featuring two pioneers in the area of RAS biology, Dr. Channing J. Der of the University of North Carolina, and Dr. E. Premkumar Reddy of Mount Sinai School of Medicine. The meeting focused on novel approaches for targeting the RAS pathway and highlighted the therapeutic potential for rigosertib as a novel RAS-directed therapy. A replay of the webcast for this event can be found by clicking the following link: http://lifesci.rampard.com/20161017/reg.jsp.
- Two peer-reviewed articles describing clinical and non-clinical studies with rigosertib in MDS were published in Expert Review of Anticancer Therapy ( link to article) and Expert Opinion on Orphan Drugs ( link to article).
- Presentation of updated data from 09-08 combination therapy trial at ASH Annual Meeting: December 2016
- Presentations highlighting safety and tolerability in more than 500 patients, and analysis of previously completed randomized clinical trial of rigosertib at ASH Annual Meeting: December 2016
- Completion of site activation for INSPIRE trial: 1Q2017
- Cash, cash equivalents and marketable securities as of September 30, 2016, totaled $25.8 million, compared to $19.8 million as of December 31, 2015.
- Total net revenue was $1.7 million for the third quarter of 2016 and $5.4 million for the nine months ended September 30, 2016, compared to $1.6 million and $1.9 million, respectively, for the comparable periods in 2015.
- Research and development expenses were $4.0 million for the third quarter of 2016 and $15.4 million for the nine months ended September 30, 2016, compared to $5.3 million and $21.3 million, respectively, for the comparable periods in 2015.
- General and administrative expenses were $2.0 million for the third quarter of 2016 and $7.2 million for the nine months ended September 30, 2016, compared to $2.2 million and $7.8 million, respectively, for the comparable periods in 2015.
Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
|ONCONOVA THERAPEUTICS, INC.|
|Condensed Consolidated Statements of Operations (unaudited)|
|(in thousands, except share and per share amounts)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|General and administrative||1,975||2,217||7,229||7,750|
|Research and development||3,991||5,282||15,377||21,292|
|Total operating expenses||5,966||7,499||22,606||29,042|
|Income (loss) from operations||(4,315||)||(5,877||)||(17,233||)||(27,183||)|
|Change in fair value of warrant liability||2,706||-||2,985||-|
|Other income (expense), net||10||4||28||(32||)|
|Net loss attributable to non-controlling interest||-||-||-||44|
|Net loss attributable to Onconova Therapeutics, Inc.||$||(1,599||)||$||(5,873||)||$||(14,220||)||$||(27,171||)|
|Net loss per share of common stock, basic and diluted||$||(0.29||)||$||(2.60||)||$||(3.90||)||$||(12.35||)|
|Basic and diluted weighted average shares outstanding||5,438,105||2,258,246||3,643,210||2,200,145|
|ONCONOVA THERAPEUTICS, INC.|
|September 30,||December 31,|
|Cash and cash equivalents||$||25,778||$||19,799|
|Prepaid expenses and other current assets||1,218||1,882|
|Total current assets||27,900||23,185|
|Property and equipment, net||176||248|
|Other non-current assets||12||12|
|Liabilities and stockholders' equity|
|Accrued expenses and other current liabilities||4,482||3,729|
|Total current liabilities||9,008||7,605|
|Deferred revenue, non-current||4,659||5,000|
|Additional paid-in capital||341,911||328,564|
|Accumulated other comprehensive loss||(17||)||(22||)|
|Total Onconova Therapeutics Inc. stockholders' equity||9,185||10,010|
|Total stockholders' equity||10,015||10,840|
|Total liabilities and stockholders' equity||$||28,088||$||23,445|
CONTACT: Onconova TherapeuticsBenjamin Hoffman, firstname.lastname@example.org