Syndax Pharmaceuticals, Inc.

Syndax Pharmaceuticals Reports Third Quarter 2016 Financial Results and Provides Business Update

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.

Pipeline Updates

Upcoming Milestones

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.

Conference Call and Webcast

In connection with the earnings release, Syndax's management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Thursday, November 10, 2016.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website at  Alternatively, the conference call may be accessed through the following:

Conference ID: 96707118
Domestic Dial-in Number: 1-855-251-6663
International Dial-in Number: 281-542-4259
Live webcast:

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company's website,

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

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.

(In thousands)September 30, 2016 December 31, 2015 
Cash, cash equivalents, and short-term investments$  115,567  $  86,489  
Total assets$  117,729  $  89,903  
Total liabilities$  23,895  $  23,205  
Total stockholders' equity (deficit)$  93,834  $  (252,415) 
Common stock outstanding   18,189,880     100,124  
Common stock and common stock equivalents*   21,055,803     15,856,356  
*Common stock and common stock equivalents:    
   September 30, 2016 December 31, 2015 
 Common stock   18,189,880     100,124  
 Convertible preferred stock   -     12,872,551  
 Options to purchase common stock   2,508,083     2,606,195  
 Common stock warrants   357,840     277,486  
      21,055,803     15,856,356  

   Three Months Ended September 30, Nine Months Ended September 30,
(In thousands, except share and per share data) 2016   2015   2016   2015 
License fee revenue $  305  $  305  $  915  $  322 
Operating expenses:        
Research and development   12,274     2,968     23,191     6,962 
General and administrative   3,269     3,195     10,349     9,194 
Total operating expenses   15,543     6,163     33,540     16,156 
Loss from operations  (15,238)  (5,858)    (32,625)    (15,834)
Other income (expense), net 269    (1,873)    (1,032)    (3,022)
Net loss   $(14,969) $ (7,731) $  (33,657) $  (18,856)
Net loss attributable to common stockholders$  (14,969) $ (56,656) $  (36,255) $  (95,066)
Net loss per share attributable to common
stockholders--basic and diluted





Weighted-average number of common stock used to compute net loss per share attributable to common stockholders--basic and diluted   17,899,481    

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