“2019 is slated to be a milestone-rich time for, with data expected from multiple trials within our ENCORE program of entinostat in combination with checkpoint therapy in platinum resistant ovarian cancer, triple negative breast cancer, and anti-PD-1-pretreated melanoma, all of which we believe represent underserved areas with significant market opportunity,” said Briggs W. Morrison, M.D., CEO of Syndax. “We also eagerly anticipate the next interim overall survival analysis in the second quarter from the Phase 3 E2112 trial of entinostat plus exemestane in HR+, HER2- breast cancer and remain highly encouraged by the potential to provide a survival benefit for HR+, HER2- breast cancer patients who have stopped responding to first line treatment with hormone therapy. Any positive overall survival assessment would enable the company to file for full regulatory approval.” Dr. Morrison added, “In addition, we remain on track for an IND filing for our Menin inhibitor, SNDX-5613, in the second quarter of 2019, followed by initiation of the clinical trial program. Acute leukemias characterized by MLL-rearrangements and nucleophosmin mutations represent areas of high unmet medical need, and the preclinical data we’ve generated thus far provide strong support that menin inhibition has the potential to serve as an effective therapy for patients lacking viable options. Finally, we continue to expect initial efficacy results for SNDX-6352 in chronic graft versus host disease in the second half of 2019.” Syndax ended 2018 with cash, cash equivalents and short-term investments of approximately $80M. For 2019, research and development expenses are expected to be $54M-$58M, and total operating expenses are expected to be $68M-$73M. Research and development expenses and total operating expenses for 2019 are expected to include approximately $2M-$6M, respectively, of non-cash stock compensation
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