Syndax Pharmaceuticals Reports Third Quarter 2018 Financial Results and Provides Clinical and Business Update
WALTHAM, Mass., /PRNewswire/ --Syndax Pharmaceuticals Inc., ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results for the third quarter ended September 30, 2018. In addition, the Company provided a clinical and business update. As of September 30, 2018, Syndax had $89.6 million in cash, cash equivalents and short-term investments. "The last several months have been marked by exciting progress across multiple programs, culminating with our recent announcement of plans to commence what will become our second registration study: a focused, biomarker-driven registration trial to evaluate entinostat in combination with pembrolizumab in patients with non-small cell lung cancer whose disease has progressed after PD-1 therapy," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "We remain highly encouraged by the potential for a positive overall survival readout for E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, which would allow us to file for full regulatory approval in this indication. We look forward to reporting on multiple exciting value inflection points across our ENCORE I/O combination trials in the coming months." Pipeline Updates Entinostat
SNDX-6352
Menin-MLLr Inhibitor Portfolio
Third Quarter 2018 Financial Results As of September 30, 2018, Syndax had cash, cash equivalents and short-term investments of $89.6 million and 26.1 million shares issued and outstanding (including a prefunded warrant for 2.0 million shares). In the third quarter of 2018 and through November 2, 2018, the Company sold 2.1 million shares of its common stock with net proceeds of approximately $15.5 million pursuant to its at-the-market arrangement. Third quarter 2018 research and development expenses increased to $14.1 million from $12.2 million for the comparable period in the prior year, an increase of $1.9 million, or 16%, due to an increase in development activities of $0.8 million and increased employee compensation expense of $1.1 million. The increase in development activities was primarily related to the development of the Menin-MMLr program and increased activities in the 602 ENCORE trial partly offset by the completion of Phase 1 clinical pharmacology trials and decrease in E2112 costs. The increase in employee compensation costs was primarily due to increased headcount. General and administrative expenses increased to $4.1 million during the third quarter of 2018, compared to $3.6 million for the comparable period in the prior year, an increase of $0.6 million, or 16%. The increase in general and administrative expenses was primarily due to an increase employee related expenses of $0.3 million and in professional and legal fees of $0.2 million. For the three months ended September 30, 2018, Syndax reported a net loss attributable to common stockholders of $17.3 million or $0.68 per share compared to $15.1 million or $0.68 per share for the comparable prior year period. Financial Guidance Today, the Company provided operating expense guidance for the fourth quarter and full year 2019. For the fourth quarter of 2018, research and development expenses are expected to be $13 to $15 million and total operating expenses are expected to be $17 to $19 million. Total operating expenses for the fourth quarter of 2018 are expected to include approximately $1.5 million of non-cash stock compensation expense. The year-end 2018 cash balance is expected to be approximately $80 million. For the full year 2019, research and development expenses are expected to be $54 to $58 million, and total operating expenses are expected to be $68 to $73 million. Total operating expenses for 2019 are expected to include approximately $6 million of non-cash stock compensation expense. 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, Monday, November 5, 2018. 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 www.syndax.com. Alternatively, the conference call may be accessed through the following: Conference ID: 8397904 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, www.syndax.com. About Syndax Pharmaceuticals, Inc. Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Company is developing its lead product candidate, entinostat, a once-weekly, oral, small molecule, class I HDAC inhibitor, in combination with exemestane and several approved PD-1/PD-(L)1 antagonists. The Company's pipeline also includes SNDX-6352, a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor, as well as a portfolio of potent and selective inhibitors targeting the binding interaction of Menin with MLLr. For more information, please visit www.syndax.com or follow the Company on Twitter and LinkedIn. 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, the potential use of our product candidates to treat various cancer indications, and Syndax's third quarter and full-year 2018 net cash used in research and development and total operating activities. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical trials, 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 Contacts Investor Contact Media Contact SNDX-G View original content:http://www.prnewswire.com/news-releases/syndax-pharmaceuticals-reports-third-quarter-2018-financial-results-and-provides-clinical-and-business-update-300744153.html SOURCE Syndax Pharmaceuticals |
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Company Codes: NASDAQ-NMS:SNDX |