NEWTOWN, Pa., May 15, 2017 (GLOBE NEWSWIRE) -- 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, today provided a corporate update and reported financial results for the first quarter ended March 31, 2017.
"We had a productive start to 2017, advancing the Phase 3 trial for our lead clinical candidate and securing funding to support ongoing clinical stage trials for patients with Myelodysplastic Syndromes (MDS). The presentation of positive data on two preclinical candidates representing potentially novel approaches for the treatment of Solid Tumors and Acute Myeloid Leukemia, Multiple Myeloma, and Lymphoma has resulted in increased interest from partners, and underscores the depth of our pipeline," said Dr. Ramesh Kumar, President and Chief Executive Officer.
"The INSPIRE Phase 3 trial for our lead clinical candidate, rigosertib, for the second-line treatment of patients with higher-risk (HR) MDS continues to advance as planned, with interim analysis and key enrollment milestones ahead. While we design our global Phase 3 trial of oral rigosertib in combination with azacitidine for first line HR MDS patients, we are expanding our Phase 2 combination trial to obtain additional efficacy and tolerability data across a larger number of trial sites. We plan to seek a Special Protocol Assessment in the United States after first obtaining Scientific Advice from the European regulatory authorities during the third quarter of this year. Thus, we are well-positioned for multiple key milestones as we seek to address the underserved needs of patients with MDS."
Enrollment Progressing for INSPIRE Trial of IV Rigosertib in 2nd Line HR-MDS
INSPIRE Trial Update
• 172 trial sites selected globally
• As of April 30, 60 sites in 14 countries have enrolled patients
INSPIRE Trial Statistical Analysis Plan (SAP)
Second Data Monitoring Committee (DMC) Review Completed
Progress on Oral Rigosertib in Combination with Azacitidine for 1st-line HR-MDS
Phase 3 Trial Protocol
Expansion of Phase 2 Trial of Oral Rigosertib in Combination with Azacitidine
Recent Data Presentation
Rare Disease Program in "Rasopathies"
Proprietary Preclinical New Chemical Entities show Positive Results
Recent Business Highlights:
First-Quarter Financial Results:
The Company will host a conference call on May 15th at 9:00 a.m. Eastern Time to provide a corporate update and discuss first quarter financial results. Interested parties may access the call by dialing toll-free (855) 428-5741 from the US, or (210) 229-8823 internationally and using conference ID: 10612725.
The call will also be webcast live at: http://investor.onconova.com/events.cfm
A replay will be available at that link until August 15, 2017.
Onconova Therapeutics, Inc. is 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). Rigosertib, Onconova's lead candidate, is a proprietary Phase 3 small molecule agent, which we believe blocks cellular signaling by targeting RAS effector pathways. Using a proprietary chemistry platform, Onconova has created a pipeline of targeted agents designed to work against specific cellular pathways that are important in cancer cells, while causing minimal damage to normal cells. Onconova has three product candidates in the clinical stage and several pre-clinical programs. Advanced clinical trials with the Company's lead compound, rigosertib, are aimed at what the Company believes are unmet medical needs of patients with MDS. For more information, please visit http://www.onconova.com.
The intravenous form of rigosertib has been employed in Phase 1, 2, and 3 clinical trials involving more than 800 patients, and is currently being evaluated in the randomized Phase 3 international INSPIRE trial for patients with higher-risk MDS, after failure of hypomethylating agent, or HMA, therapy. This formulation is intended for patients with advanced disease, provides long duration of exposure, and ensures dosing under a controlled setting.
The INternational Study of Phase III IV RigosErtib, or INSPIRE, is based on guidance received from the U.S. Food and Drug Administration and European Medicines Agency and derives from the findings of the ONTIME Phase 3 trial. INSPIRE is a multi-center, randomized controlled study to assess the efficacy and safety of IV rigosertib in HR-MDS patients who had progressed on, failed to respond to, or relapsed after previous treatment with an HMA within the first 9 months or 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. The trial will enroll approximately 225 patients randomized at a 2:1 ratio into two treatment arms: IV rigosertib plus Best Supportive Care versus Physician's Choice plus Best Supportive Care. The primary endpoint of INSPIRE is overall survival and an interim analysis is anticipated. 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 Oral Rigosertib
The oral form of rigosertib was developed to provide more convenient dosing for use where the duration of treatment may extend to multiple years. This dosage form also supports many combination therapy modalities. To date, 368 patients have been treated with the oral formulation of rigosertib. Initial studies with single-agent oral rigosertib were conducted in hematological malignancies, lower-risk MDS, and solid tumors. Combination therapy of oral rigosertib with azacitidine and chemoradiotherapy has also been explored. 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 2 trial of the combination therapy has been fully enrolled and the preliminary results were presented in 2016. This novel combination is the subject of an issued US patent with earliest expiration in 2028.
Forward Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to future events or Onconova Therapeutics, Inc.'s future operations, clinical development of Onconova's product candidates and presentation of data with respect thereto, regulatory approvals, expectations regarding the sufficiency of Onconova's cash and other resources to fund operating expenses and capital expenditures, Onconova's anticipated milestones and future expectations and plans and prospects. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Onconova has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including Onconova's ability to continue as a going concern, the need for additional financing and current plans and future needs to scale back operations if adequate financing is not obtained, the success and timing of Onconova's clinical trials and regulatory approval of protocols, and those discussed under the heading "Risk Factors" in Onconova's most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q.
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 Balance Sheets|
|March 31,||December 31,|
|Cash and cash equivalents||$||15,389||$||21,400|
|Prepaid expenses and other current assets||898||1,638|
|Total current assets||16,413||23,069|
|Property and equipment, net||129||152|
|Other non-current assets||12||12|
|Liabilities and stockholders' equity|
|Accrued expenses and other current liabilities..||4,021||4,382|
|Total current liabilities||9,883||10,160|
|Deferred revenue, non-current||4,432||4,545|
|Additional paid in capital||342,982||342,484|
|Accumulated other comprehensive income||(26||)||(31||)|
|Total Onconova Therapeutics Inc. stockholders' equity||(3,541||)||4,297|
|Total stockholders' (deficit) equity||(2,711||)||5,127|
|Total liabilities and stockholders' (deficit) equity||$||16,554||$||23,233|
|ONCONOVA THERAPEUTICS, INC.|
|Condensed Consolidated Statements of Operations (unaudited)|
|(in thousands, except share and per share amounts)|
|Three Months Ended March 31,|
|General and administrative||2,116||3,172|
|Research and development||4,886||5,822|
|Total operating expenses||7,002||8,994|
|Loss from operations||(6,792||)||(7,520||)|
|Change in fair value of warrant liability||(1,549||)||271|
|Other income, net||-||9|
|Net loss per share of common stock, basic and diluted||$||(1.23||)||$||(2.65||)|
|Basic and diluted weighted average shares outstanding||6,771,383||2,731,590|
GENERAL CONTACT: http://www.onconova.com/contact/ INVESTOR RELATIONS CONTACT: Lisa Sher, MBS Value Partners on behalf of Onconova Therapeutics Lisa.Sher@mbsvalue.com / (212) 750-5800