Print 10 November 2016
Execution on clinical timelines and advancement of oncology programs continues with initiation of:
WALTHAM, Mass., Nov. 10, 2016 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company focused on developing entinostat and SNDX-6352 in multiple cancer indications, today reported its financial results for the third quarter ended September 30, 2016. In addition, the Company provided a pipeline update as well as a review of upcoming milestones. As of September 30, 2016, Syndax had $115.6 million in cash, cash equivalents and short-term investments.
"We continue to advance our innovative pipeline and anticipate having five clinical trials in six cancer indications up and running by the end of the year," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "We believe the continued execution of our strategy will bring us closer to achieving our mission and realizing a future in which people with cancer live longer and better than ever before."
"According to ECOG, the accelerated pace of patient accrual in E2112, the Phase 3 registration clinical trial of entinostat in advanced HR+, HER2- breast cancer, now puts us on track to complete enrollment and should allow for the analysis of the progression-free survival results in the second half of 2017," said Dr. Michael L. Meyers, Chief Medical Officer of Syndax.
Syndax Expects to Participate in the Following Upcoming Conferences
Third Quarter 2016 Financial Results
As of September 30, 2016, Syndax had cash, cash equivalents and short-term investments of $115.6 million and 18,189,880 shares issued and outstanding.
Third quarter 2016 research and development expenses increased to $12.3 million from $3.0 million for the comparable period in the prior year primarily due to increased patient accrual costs in E2112, higher expenses associated with the Phase 2 expansion of ENCORE 601, and the commencement of ENCORE 602 as well as the upfront payment related to expanding the pipeline with SNDX-6352.
General and administrative expenses totaled $3.3 million during the third quarter of 2016, similar to the $3.2 million expense level for the comparable prior year period.
For the three months ended September 30, 2016, Syndax reported a net loss attributable to common stockholders of $15.0 million or $0.84 per share compared to $56.7 million or $790.85 per share for the comparable prior year period. The net loss for the three months ended September 30, 2016 included non-cash stock-based compensation expense of $0.8 million related to the issuance of stock option awards to employees.
About Syndax Pharmaceuticals, Inc.
Syndax is a clinical stage biopharmaceutical company focused on developing an innovative pipeline of combination therapies in multiple cancer indications. Our lead product candidate, entinostat, which was granted Breakthrough Therapy designation by the FDA following positive results from our Phase 2b clinical trial, ENCORE 301, is currently being evaluated in a Phase 3 registration clinical trial for advanced hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer. Syndax is developing entinostat, which has direct effects on both cancer cells and immune regulatory cells, and SNDX-6352, an anti-CSF-1R monoclonal antibody, to potentially enhance the body's immune response on tumors that have shown sensitivity to immunotherapy. Entinostat is being evaluated as a combination therapeutic in Phase 1b/2 clinical trials with Merck & Co., Inc. for non-small cell lung cancer and melanoma, with Genentech, Inc. for TNBC, and with Pfizer Inc. and Merck KGaA, Darmstadt, Germany, for ovarian cancer. SNDX-6352 is being evaluated in a single ascending dose Phase 1 clinical trial and is expected to be developed to treat a variety of cancers. For more information on Syndax, please visit www.syndax.com.
Syndax's Cautionary Note on Forward-Looking Statements.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for Syndax's product candidates, and the potential use of SNDX-6352 to treat various cancer indications. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including, without limitation, the factors contained under the caption "Risk Factors" in Syndax's quarterly reports on Form 10-Q. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
|SYNDAX PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS DATA|
|(In thousands)||June 30, 2016||December 31, 2015|
|Cash, cash equivalents, and short-term investments||$||125,457||$||86,489|
|Total stockholders' equity (deficit)||$||106,241||$||(252,415||)|
|Common stock outstanding||17,782,150||100,124|
|Common stock and common stock equivalents*||20,855,418||15,856,356|
|*Common stock and common stock equivalents:|
|June 30, 2016||December 31, 2015|
|Convertible preferred stock||-||12,872,551|
|Options to purchase common stock||2,715,428||2,606,195|
|Common stock warrants||357,840||277,486|
|SYNDAX PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS DATA|
|Three Months Ended June 30,||Six Months Ended June 30,|
|(In thousands, except share and per share data)||2016||2015||2016||2015|
|License fee revenue||$||305||$||17||$||610||$||17|
|Research and development||6,131||2,271||10,917||3,994|
|General and administrative||2,808||3,288||7,080||5,999|
|Total operating expenses||8,939||5,559||17,997||9,993|
|Loss from operations||(8,634||)||(5,542||)||(17,387||)||(9,976||)|
|Other income (expense), net||276||(672||)||(1,301||)||(1,149||)|
|Net loss attributable to common stockholders||$||(8,358||)||$||(26,338||)||$||(21,286||)||$||(38,410||)|
|Net loss per share attributable to common|
|stockholders--basic and diluted||$||(0.47||)||$||(440.52||)||$||(1.91||)||$||(649.30||)|
|Weighted-average number of common stock|
|used to compute net loss per share attributable|
|to common stockholders--basic and diluted||17,769,514||59,788||11,155,525||59,156|
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