NEWTOWN, Pa., March 10, 2014 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (Nasdaq:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today provided a corporate update and reported financial results for its year ended December 31, 2013.
"2013 was an important year for Onconova. During the year we completed our initial public offering and fully enrolled the Phase 3 ONTIME trial in higher risk myelodysplastic syndromes (MDS) for our lead product candidate, rigosertib. We announced positive Phase 2 results for rigosertib in patients with transfusion-dependent lower risk MDS opening the path to a pivotal trial in this important underserved patient population," commented Ramesh Kumar, Ph.D., President and CEO of Onconova. "Last month, we announced top-line analysis of the Phase 3 ONTIME trial. Although the results of this study showed numerical improvement in median overall survival in the rigosertib-treated patients, the observed improvement of 2.4 months did not meet the required level of statistical significance. Encouragingly, a statistically significant improvement in median overall survival was evident in the subset of patients who had progressed on or failed to respond to previous treatment with hypomethylating agents (HMAs). In this group, the overall survival benefit was 3.8 months with Hazard Ratio of 0.67 and p-value of 0.022. These results provide evidence of rigosertib activity in a randomized trial with a survival endpoint in a subset that represents a significant proportion of post-HMA treated MDS patients. We remain committed to discussions with the regulatory authorities in the U.S. and Europe and to advancing rigosertib in order to address important unmet medical needs in MDS and solid tumors," continued Dr. Kumar.
Recent Developments in the Rigosertib Clinical Program
Top-line Analysis of Phase 3 ONTIME Trial of IV Rigosertib in Higher Risk MDS
Further Development and Potential Prognostic Tool in Lower Risk MDS with Oral Rigosertib
Front-line Study in MDS Patients with a Combination of Azacitidine and Oral Rigosertib
On Mechanism of Action of Rigosertib
Key Upcoming Milestones
2013 Financial Results
Today's Conference Call at 4:30 PM ET
Onconova will host a conference call and audio webcast to discuss its fourth quarter and year-end financial results this afternoon at 4:30 PM ET. A live webcast will be available at this link or can be accessed by visiting "Events & Presentations" in the Investors and Media section of the Company's website at www.onconova.com. The call can be accessed by dialing (877) 312-5881 (domestic) or (253) 237-1173 (international) five minutes prior to the start time and providing the Conference ID 9033414. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company's website for two weeks following the call.
About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer. Onconova's clinical and pre-clinical stage drug development candidates are derived from its extensive chemical library and are designed to work against specific cellular pathways that are important in cancer cells, while causing minimal damage to normal cells. In addition to rigosertib, the Company's most advanced product candidate, two other candidates are in clinical trials, and several candidates are in pre-clinical stages. For more information, please visit http://www.onconova.com.
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, which 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, expectations regarding the sufficiency of Onconova's cash balance 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 those discussed under the heading "Risk Factors" in our Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission on June 14, 2013, as amended (Registration No. 333-189358).
Any forward-looking statements contained in this release speak only as of its date. We undertake 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 Sheet | ||
(in thousands) | ||
December 31, | December 31, | |
2013 | 2012 | |
Assets | ||
Current assets: | ||
Cash and cash equivalents | $ 60,009 | $ 81,527 |
Marketable securities | 39,994 | -- |
Prepaid expenses and other current assets | 4,387 | 1,725 |
Total current assets | 104,390 | 83,252 |
Property and equipment, net | 626 | 463 |
Other non-current assets | 137 | 137 |
Total assets | $ 105,153 | $ 83,852 |
Liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | ||
Current liabilities: | ||
Accounts payable | $ 3,710 | $ 5,517 |
Accrued expenses and other current liabilities | 5,840 | 3,987 |
Option liability | -- | 11,967 |
Deferred revenue | 788 | 3,907 |
Total current liabilities | 10,338 | 25,378 |
Deferred revenue, non-current | 13,909 | 15,421 |
Other | 6 | 44 |
Total liabilities | 24,253 | 40,843 |
Redeemable convertible preferred stock | -- | 201,315 |
Stockholders' equity (deficit): | ||
Preferred stock | -- | -- |
Common stock | 215 | 26 |
Additional paid in capital | 311,093 | 10,021 |
Accumulated other comprehensive income | 1 | -- |
Accumulated deficit | (230,896) | (168,353) |
Total Onconova Therapeutics Inc. stockholders' equity (deficit) | 80,413 | (158,306) |
Non-controlling interest | 487 | -- |
Total stockholders' equity (deficit) | 80,900 | (158,306) |
Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | $ 105,153 | $ 83,852 |
Onconova Therapeutics, Inc. | ||||
Condensed Consolidated Statements of Operations | ||||
(in thousands, except share and per share amounts) | ||||
Three Months Ended December 31, | Year Ended December 31, | |||
2013 | 2012 | 2013 | 2012 | |
Revenue | $ 1,930 | $ 2,969 | $ 4,753 | $ 46,190 |
Operating expenses: | ||||
General and administrative | 4,403 | 2,698 | 16,793 | 15,707 |
Research and development | 12,086 | 10,576 | 50,182 | 52,762 |
Total operating expenses | 16,489 | 13,274 | 66,975 | 68,469 |
Income (loss) from operations | (14,559) | (10,305) | (62,222) | (22,279) |
Change in fair value of warrant liability | 61 | 2 | 42 | 367 |
Interest expense | (1) | -- | (4) | (8,608) |
Other income, net | (126) | 41 | 63 | 608 |
Net loss before income taxes | (14,625) | (10,262) | (62,121) | (29,912) |
Income taxes | 3 | -- | 435 | -- |
Net loss | (14,628) | (10,262) | (62,556) | (29,912) |
Net loss attributable to non-controlling interest | 13 | -- | 13 | -- |
Net loss attributable to Onconova Therapeutics, Inc. | (14,615) | (10,262) | (62,543) | (29,912) |
Accretion of redeemable convertible preferred stock | -- | (1,010) | (2,320) | (3,953) |
Net loss applicable to common stockholders | $ (14,615) | $ (11,272) | $ (64,863) | $ (33,865) |
Net loss per share of common stock, basic and diluted | $ (0.68) | $ (4.89) | $ (6.12) | $ (15.35) |
Basic and diluted weighted average shares outstanding | 21,419,208 | 2,305,315 | 10,594,227 | 2,206,888 |