Syndax Pharmaceuticals (SNDX) Tops Q4 EPS by 5c

Syndax Pharmaceuticals (NASDAQ: SNDX) reported Q4 EPS of ($0.44), $0.05 better than the analyst estimate of ($0.49).

"We expect 2021 will be a year of immense progress across our two highly promising programs aimed at addressing key areas of unmet need, coupled with a sharp focus on pipeline expansion," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "Notably, we plan to present data from the Phase 1 portion of our ongoing AUGMENT-101 trial of SNDX-5613, our selective menin inhibitor, in patients with acute leukemias. We presented promising initial clinical data at the 2020 AACR Annual Meeting that provided the first clinical evidence that disrupting the interaction between menin and MLL1 can induce rapid responses in difficult to treat acute leukemias. We look forward to sharing updated results which further expand on SNDX-5613's potential to meaningfully alter the treatment paradigm in genetically-defined acute leukemias."

"Additionally, on the heels of positive data presented at the ASH Annual Meeting in December from our Phase 1 trial of axatilimab, our anti-CSF-1R monoclonal antibody, in patients with cGVHD, we are pleased to announce that our pivotal Phase 2 AGAVE-101 trial is now underway. Through inhibition of monocyte derived macrophages, axatilimab has demonstrated important clinical benefits in multiple organ systems. We believe axatilimab could represent a meaningful therapeutic option for additional fibrotic diseases where macrophages have been shown to play a significant role, and we are actively exploring additional indications."

Financial Update and Guidance

In December 2020, Syndax issued 6,250,000 shares of its common stock at $23.00 per share. As a result of the offering, Syndax received gross proceeds of approximately $143.8 million.

For the first quarter of 2021, research and development expenses are expected to be $25 to $30 million, and total operating expenses are expected to be $30 to $35 million. For the full year of 2021, research and development expenses are expected to be $90 to $100 million, and total operating expenses are expected to be $110 to $120 million.

For earnings history and earnings-related data on Syndax Pharmaceuticals (SNDX) click here.

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