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:
  • Phase 2 cohorts of ENCORE 601 in NSCLC and melanoma
  • Phase 1 clinical trial of SNDX-6352

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
  • E2112 is now 60% enrolled as patient accrual has continued at an accelerated pace. This Phase 3 registration clinical trial of entinostat plus Aromasin ® (exemestane tablets) in advanced HR+, HER2- breast cancer is being conducted in collaboration with Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group ("ECOG") and the National Cancer Institute under a special protocol assessment ("SPA") with the U.S. Food and Drug Administration ("FDA"). Entinostat was granted Breakthrough Therapy designation by the FDA for this indication following positive results from the Company's Phase 2b clinical trial, ENCORE 301.
  • The Company initiated enrollment of the three cohorts in the first stage of the Phase 2 component of ENCORE 601 in patients with non-small cell lung cancer ("NSCLC") and melanoma. Previously, Syndax announced the completion of enrollment for the dose confirmation stage of ENCORE 601, an open-label, Phase 1b/2 clinical trial evaluating the combination of entinostat plus Merck's anti-PD-1 blocking therapy, KEYTRUDA ® (pembrolizumab), in patients with NSCLC.
  • The Phase 1b portion of ENCORE 602, a Phase 1b/2 clinical trial evaluating the combination of entinostat plus Genentech's PD-L1 inhibitor, Tecentriq TM (atezolizumab), in patients with triple negative breast cancer ("TNBC") continues to enroll on schedule. The trial's open label Phase 1b portion is designed to assess the safety of a 5 mg dose.
  • Syndax commenced enrollment in the Phase 1 single ascending dose clinical trial of SNDX-6352 in healthy volunteers to determine the safety and pharmacokinetics of the anti-CSF-1R monoclonal antibody.
  • In collaboration with Pfizer Inc. and Merck KGaA, Darmstadt, Germany, Syndax began prescreening patients for enrollment in the Phase 1b portion of ENCORE 603, a Phase 1b/2 clinical trial evaluating entinostat in combination with an investigational monoclonal antibody targeting PDL-1, avelumab, in patients with ovarian cancer.

Upcoming Milestones
  • According to ECOG, based upon current enrollment trends, Syndax expects that E2112, a Phase 3 registrational clinical trial of entinostat in HR+, HER2- breast cancer, will be fully enrolled and an analysis of progression-free survival will likely be available in the second half of 2017. 
  • Syndax anticipates making a go/no go decision to progress into the second stage for each arm of ENCORE 601 in the Phase 2 trial in patients with advanced metastatic or recurrent NSCLC or melanoma by the end of the first quarter of 2017.
  • In collaboration with Pfizer Inc. and Merck KGaA, Darmstadt, Germany, Syndax anticipates commencing enrollment in the Phase 1b portion of ENCORE 603 study in patients with ovarian cancer by the end of the fourth quarter of 2016.
  • The Company anticipates safety data from the Phase 1b dose determination portion of ENCORE 602 in patients with TNBC and the Phase 1b safety portion of ENCORE 603 in patients with ovarian cancer in the first half of 2017.

Syndax Expects to Participate in the Following Upcoming Conferences
  • Syndax plans to present safety, biomarker and initial efficacy data from the completed Phase 1b portions of the ENCORE 601 trial in patients with NSCLC and preclinical data for SNDX-6352 in two separate posters at the Society for Immunotherapy of Cancer Annual Meeting in National Harbor, MD on Friday, November 11, 2016.
  • Syndax management will participate in the ROTH Innovations in Oncology Corporate Access Day in New York on November 17, 2016.
  • Syndax management will participate in the Oppenheimer 2016 Life Sciences Summit in New York on November 29, 2016.
  • Syndax management will present at the 28 th Annual Piper Jaffray Healthcare Conference being held in New York on November 29 and 30, 2016.
  • Syndax will present a poster describing the ENCORE 602 Phase 1b/2 trial in the Trials in Progress track at the San Antonio Breast Cancer Symposium on December 6 through 10, 2016.
  • Syndax management will participate in the Citi 2016 Global Healthcare Conference being held in New York on December 7 and 8, 2016. 
  • Syndax management will participate in the Guggenheim Securities 4th Annual Boston Healthcare Conference in Boston on December 13, 2016.

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.

If you liked this article you might like

Jim Cramer's 'Mad Money' Recap: Why You Should Never, Ever Trade on Headlines