Syndax Pharmaceuticals Reports 2nd Quarter 2022 Financial Results and Provides Clinical and Business Update.

WALTHAM, Mass: 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 and provided a business update for the second quarter ended June 30, 2022.

"The coming quarters are poised to be transformational for Syndax with topline data from both the revumenib and axatilimab pivotal programs expected starting in the first half of 2023," said Michael A. Metzger, Chief Executive Officer. "As we continue to advance these programs in areas of significant unmet need, we are focused on executing a broad clinical development plan that fully realizes the potential of both compounds and builds upon the robust datasets presented to date."

For revumenib, which we believe is positioned to serve as a first-to-market and best-in-class menin inhibitor for patients with mNPM1 and MLLr acute leukemias, we look forward to sharing updated data from the Phase 1 portion of the AUGMENT-101 trial, enrolling patients with relapsed/refractory (R/R) disease, in the fourth quarter of this year. Beyond the R/R setting, we are committed to creating additional value for the revumenib program by expanding into newly diagnosed and maintenance settings in mNPM1 and MLLr acute leukemias, as well as into colorectal cancer (CRC), our first assessment of revumenib in solid tumors. We also expect similarly broad utility with axatilimab, which we believe could have a meaningful impact in multiple fibrotic diseases. Building on the data in chronic graft versus host disease (cGVHD), we are looking forward to initiating a 52-week Phase 2b trial of axatilimab in patients with idiopathic pulmonary fibrosis (IPF) in the fourth quarter of this year.

Recent Pipeline Progress and Anticipated Milestones

Revumenib

The pivotal Phase 2 portion of AUGMENT-101 is ongoing and the Company continues to expect completion of enrollment in one of the three pivotal cohorts by year-end. The trials are enrolling a total of 64 adult and up to 10 pediatric patients across each of three distinct trial populations: patients with NPM1 mutant acute myeloid leukemia (AML), patients with MLLr AML, and patients with MLLr acute lymphocytic leukemia (ALL). Based on discussions with the U.S. Food and Drug Administration, AUGMENT-101 may serve as the basis for regulatory filings in each of the three distinct populations. The Company expects to report topline data...