Syndax Pharmaceuticals (NASDAQ: SNDX) reported Q1 EPS of ($0.56), $0.05 worse than the analyst estimate of ($0.51).

"During the first quarter, we generated significant momentum that we believe will take us through what we expect will be a transformational year for Syndax, with key data readouts expected across the entirety of our portfolio," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "We continue to anticipate the final overall survival readout from E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer later this quarter, with a potential regulatory filing for entinostat in HR+ breast cancer by year end. Supported by the compelling overall survival benefit observed in the Phase 2b ENCORE 301 trial, we believe the combination of entinostat and exemestane has strong potential to serve as a much-needed option in a setting for which existing therapies are inadequate. While we await this final readout, we remain focused on preparations to establish ourselves as a fully integrated oncology company, with a potential launch expected in 2021."

Dr. Morrison added, "Beyond entinostat, we were pleased to recently announce initial Phase 1 data from the AUGMENT-101 trial of SNDX-5613, our oral menin inhibitor, in adults with relapsed/refractory acute leukemias. These data provide the first clinical evidence that inhibition of the menin-MLL1 interaction can induce response in patients with MLL-r acute leukemias. We believe that SNDX-5613 has great potential to serve as an effective intervention for both MLL-r acute leukemias and NPM1 mutant AML, and we look forward to presenting additional data from this trial in the fourth quarter of this year. With a strong balance sheet, which includes proceeds from our recent follow-on offering, we believe we are well positioned to execute on upcoming milestones."

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