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NEWTOWN, Pa., Aug. 13, 2015 (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 the three and six months ended June 30, 2015.
“Following receipt of regulatory guidance, we have completed the design of a proposed Phase 3 pivotal trial for IV rigosertib in patients with higher-risk myelodysplastic syndrome (HR-MDS) after failure of hypomethylating agent (HMA) therapy. We are finalizing our IND submission for the trial and intend to initiate enrollment in this study in the second half of 2015,” said Ramesh Kumar, Ph.D., President and CEO of Onconova. “In addition, a Phase 2 trial of oral rigosertib in combination with azacitidine in MDS and AML is approaching full enrollment. We expect to present data from this study later this year.”
Recent Business Highlights:
Development of Rigosertib IV in Higher-Risk MDS (HR-MDS)
Development of Oral Rigosertib in Combination with Azacitidine for MDS and AML Patients
Development of Oral Rigosertib in Lower-Risk MDS (LR-MDS)
Second Quarter 2015 Financial Results
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 clinical stage, and several candidates are in pre-clinical stages. For more information, please visit http://www.onconova.com.
Rigosertib is a small molecule that inhibits cellular signaling by acting as a Ras mimetic. This is believed to be mediated by direct binding of rigosertib to the Ras-binding domain (RBD) found in many Ras effector proteins, including the Raf kinases and PI3K. The initial therapeutic focus for rigosertib is myelodysplastic syndromes (MDS), a group of bone marrow disorders characterized by ineffective formation of blood cells that often converts into acute myeloid leukemia (AML). Clinical trials with intravenous (IV) and oral formulations of rigosertib are being conducted at leading institutions in the U.S. and Europe.
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, 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 our 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 our clinical trials and regulatory approval of protocols, and those discussed under the heading “Risk Factors” in our 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. 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|
|June 30,||December 31,|
|Cash and cash equivalents||$||25,358||$||43,582|
|Prepaid expenses and other current assets||2,017||3,198|
|Total current assets||27,425||46,905|
|Property and equipment, net||300||420|
|Other non-current assets||12||12|
|Liabilities and stockholders' equity|
|Accrued expenses and other current liabilities||5,295||5,777|
|Total current liabilities||9,935||10,259|
|Deferred revenue, non-current||13,227||13,455|
|Additional paid-in capital||319,418||317,122|
|Accumulated other comprehensive income||(14||)||(13||)|
|Total Onconova Therapeutics Inc. stockholders' equity||3,745||22,748|
|Total stockholders' equity||4,575||23,622|
|Total liabilities and stockholders' equity||$||27,737||$||47,337|
| ONCONOVA THERAPEUTICS, INC.|
| Condensed Consolidated Statements of Operations (unaudited)|
| (in thousands, except share and per share amounts)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|General and administrative||2,568||3,985||5,533||8,917|
|Research and development||6,512||12,904||16,010||27,152|
|Total operating expenses||9,080||16,889||21,543||36,069|
|Income (loss) from operations||(8,957||)||(16,764||)||(21,306||)||(35,497||)|
|Change in fair value of warrant liability||-||3||-||19|
|Other income (expense), net||(18||)||(19||)||(36||)||(18||)|
|Net loss attributable to non-controlling interest||20||27||44||64|
|Net loss attributable to Onconova Therapeutics, Inc.||$||(8,955||)||$||(16,753||)||$||(21,298||)||$||(35,432||)|
|Net loss per share of common stock, basic and diluted||$||(0.41||)||$||(0.77||)||$||(0.98||)||$||(1.64||)|
|Basic and diluted weighted average shares outstanding||21,709,054||21,658,625||21,706,130||21,613,713|
CONTACT: Onconova Therapeutics Benjamin Hoffman, 267-759-3036 firstname.lastname@example.orgNEXT ARTICLE
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