Print 16 May 2016
ENCORE 601 Phase 1b dose escalation has been completed and safety confirmation has commenced at the 5 mg dose
WALTHAM, Mass., May 16, 2016 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals ("Syndax" or the "Company") (Nasdaq:SNDX), a clinical stage biopharmaceutical company focused on developing entinostat in multiple cancer indications, today reported its financial results for the first quarter ended March 31, 2016, and provided a pipeline update and review of upcoming milestones. As of March 31, 2016, Syndax had $133.7 million in cash, cash equivalents and short-term investments.
"The first quarter of 2016 marked a significant milestone for Syndax with the completion of our initial public offering in March. Our Company now has both the financial resources and the experienced leadership team required to accelerate the development of entinostat as a combination therapy in multiple cancer indications and to expand our pipeline," said Dr. Briggs Morrison, Chief Executive Officer of Syndax.
"We are pleased to have completed the initial dose escalation stage of ENCORE 601 and following the investigators' recommendation, we have begun the next dose confirmation stage at the 5mg dose," said Dr. Michael L. Meyers, Chief Development Officer of Syndax. "We look forward to communicating the results of our ongoing entinostat clinical trials in a variety of oncologic indications."
Key Recent Achievements
Syndax Expects To Make Presentations at the Following Upcoming Conference
First Quarter 2016 Financial Results
As of March 31, 2016, Syndax had cash, cash equivalents and short-term investments of $133.7 million. As of March 31, 2016, Syndax had 17,782,150 shares outstanding.
For the three months ended March 31, 2016, Syndax recognized license fees of $0.3 million derived from the license agreement with Kyowa Hakko Kirin Co., Ltd.
First quarter 2016 research and development expenses increased $3.1 million, or 178%, to $4.8 million from $1.7 million for the comparable period in the prior year due to increased clinical trial activities in E2112 and ENCORE 601 and trial start-up costs for ENCORE 602.
General and administrative expenses increased to $4.3 million during the first quarter of 2016, from $2.7 million for the comparable period in the prior year primarily due to non-cash stock-based compensation.
For the three months ended March 31, 2016, Syndax reported a net loss attributable to common stockholders of $12.9 million, or $2.85 per share, compared to a net loss attributable to common stockholders of $12.1 million, or $206.30 per share, for the comparable period in the prior year. The net loss per share calculation for the three months ended March 31, 2016 and 2015 includes the impact of dividends and accretion on the convertible preferred stock, which converted into common stock upon the completion of the initial public offering in March 2016 and will not impact quarterly net loss calculations in the future.
Conference Call and Webcast
In connection with the earnings release, Syndax will host a conference call and live audio webcast at 4:30 p.m. ET on Monday, May 16, 2016 to discuss the financial results and give an update on the Company's progress.
Conference Call Information:
Date: Monday, May 16, 2016
Time: 4:30 p.m. ET
Domestic Dial-in Number: 1-855-238-6664
International Dial-in Number: 1-262-912-4798
Live webcast: http://edge.media-server.com/m/p/msy6sdt8
For those unable to participate in the conference call or live webcast, a live audio webcast of the call will also be available on the Investor section of the Company's website, www.syndax.com, where a webcast replay will also be available for two weeks following the live event.
About Syndax Pharmaceuticals, Inc.
Syndax is a clinical stage biopharmaceutical company developing entinostat as a combination therapy in multiple cancer indications. Entinostat, which was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration following positive results from our Phase 2b clinical trial, ENCORE 301, is currently being evaluated in a Phase 3 clinical trial for advanced hormone receptor positive breast cancer. Concurrently, Syndax is developing entinostat with a focus on tumors that have shown sensitivity to immunotherapy, including lung cancer, melanoma, ovarian cancer and triple-negative breast cancer (TNBC). Entinostat is an oral, small molecule drug candidate that has direct effects on both cancer cells and immune regulatory cells, potentially enhancing the body's immune response to tumors. 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 Merck KGaA, Darmstadt, Germany, and Pfizer Inc. for ovarian cancer. 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 and scope of clinical trials and the reporting of clinical data for Syndax's product candidate. 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 the "Risk Factors" sections contained therein. 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 SHEET DATA|
|(In thousands)||March 31, 2016||December 31, 2015|
|Cash, cash equivalents, and short-term investments||$||133,670||$||86,489|
|Total stockholders' equity (deficit)||$||113,846||$||(252,415||)|
|Common stock outstanding||17,782,150||100,124|
|Common stock and common stock equivalents*||20,857,529||15,856,356|
|SYNDAX PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS DATA|
|Three Months Ended March 31,|
|(In thousands, except share and per share data)||2016||2015|
|License fee revenue||$||305||$||-|
|Research and development||4,786||1,723|
|General and administrative||4,272||2,711|
|Total operating expenses||9,058||4,434|
|Loss from operations||(8,753||)||(4,434||)|
|Other expense, net||(1,577||)||(477||)|
|Net loss attributable to common stockholders||$||(12,928||)||$||(12,072||)|
|Net loss per share attributable to common|
|stockholders--basic and diluted||$||(2.85||)||$||(206.30||)|
|Weighted-average number of common stock|
|used to compute net loss per share attributable|
|to common stockholders--basic and diluted||4,541,536||58,517|
|*Common stock and common stock equivalents:|
|March 31, 2016||December 31, 2015|
|Convertible preferred stock||-||12,872,551|
|Options to purchase common stock||2,717,539||2,606,195|
|Common stock warrants||357,840||277,486|
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