Encore 601 refractory melanoma cohort to proceed to second stage of Phase 2; pre-specified objective response criteria satisfied
Enrollment of the first stage of both NSCLC cohorts completed; decision whether to progress each cohort into the second stage of Phase 2 anticipated in 1H2017
WALTHAM, Mass., March 02, 2017 (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 fourth quarter and year ended December 31, 2016. In addition, the Company provided a pipeline update as well as a review of upcoming milestones. As of December 31, 2016, Syndax had $105.3 million in cash, cash equivalents and short-term investments.
"We're pleased to report that the melanoma cohort of ENCORE 601 has met the pre-specified objective response threshold to advance into the second stage of the phase 2 trial and will re-open enrollment immediately," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "The goal of the first stage of the trial was to determine whether the combination of entinostat and Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), could generate a meaningful response in patients enrolled in each cohort. Specifically, in the cohort of melanoma patients who had experienced disease progression while on a PD-1 antagonist, a minimum of 2 out of 13 patients needed to demonstrate a confirmed objective response for this cohort to advance to the next stage. The trial will now enroll an additional 21 patients, with accrual targeted to be completed by the end of the fourth quarter of this year."
"This is an encouraging early signal for entinostat combined with KEYTRUDA®, as this population of patients is poorly served by existing therapies. We are looking forward to seeing the stage one results of this combination in the non-small cell lung cancer cohorts of ENCORE 601 as well," said Michael L. Meyers, M.D., Ph.D., Chief Medical Officer of Syndax.
Syndax Expects to Participate in the Following Upcoming Conferences
Fourth Quarter and Year-end 2016 Financial Results
As of December 31, 2016, Syndax had cash, cash equivalents and short-term investments of $105.3 million and 18,223,723 shares issued and outstanding.
Fourth quarter 2016 research and development expenses increased to $8.5 million from $2.6 million for the comparable period in the prior year. Research and development expenses for the year ended December 31, 2016 increased to $31.7 million compared to $9.5 million for the prior year. These increases were 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 and initiation of a Phase 1 trial.
General and administrative expenses totaled $3.0 million during the fourth quarter of 2016 and $13.3 million for the year, similar to the $2.4 million and $11.6 million expense level for the respective prior year periods.
For the three months ended December 31, 2016, Syndax reported a net loss attributable to common stockholders of $10.8 million or $0.59 per share compared to $8.8 million or $105.57 per share for the comparable prior year period. For the year ended December 31, 2016, Syndax reported a net loss attributable to common stockholders of $47.1 million or $3.22 per share, compared to $103.8 million or $1,519.27 per share for the prior year period.
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, March 2, 2017.
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: 63366789
Domestic Dial-in Number: 1-855-251-6663
International Dial-in Number: 281-542-4259
Live webcast: http://edge.media-server.com/m/p/6txfuwhh
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 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 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 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 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 SHEETS|
|Cash, cash equivalents, and short-term investments||$||105,330||$||86,489|
|Total stockholders' equity (deficit)||$||84,139||$||(252,415||)|
|Common stock outstanding||18,223,723||100,124|
|Common stock and common stock equivalents*||21,142,300||15,856,356|
|*Common stock and common stock equivalents:|
|Convertible preferred stock||-||12,872,551|
|Options to purchase common stock||2,560,737||2,606,195|
|Common stock warrants||357,840||277,486|
|SYNDAX PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended December 31,||Year Ended December 31,|
|(In thousands, except share and per share data)||2016||2015||2016||2015|
|License fee revenue||$||305||$||305||$||1,220||$||627|
|Research and development||8,474||2,587||31,665||9,549|
|General and administrative||2,972||2,397||13,321||11,591|
|Total operating expenses||11,446||4,984||44,986||21,140|
|Loss from operations||(11,141||)||(4,679||)||(43,766||)||(20,513||)|
|Other income (expense), net||326||(584||)||(706||)||(3,606||)|
|Net loss attributable to common stockholders||$||(10,815||)||$||(8,779||)||$||(47,070||)||$||(103,845||)|
|Net loss per share attributable to common|
|stockholders--basic and diluted||$||(0.59||)||$||(105.57||)||$||(3.22||)||$||(1,519.27||)|
|Weighted-average number of common stock|
|used to compute net loss per share attributable|
|to common stockholders--basic and diluted||18,193,027||83,157||14,619,716||68,352|
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