Syndax Q2 2024 Financial Results and Business Update

Syndax Pharmaceuticals, a biopharmaceutical firm based in Waltham, Massachusetts, has reported its financial performance for the quarter ending June 30, 2024. The company has also provided an update on its ongoing business ventures and pipeline progress.

CEO Michael A. Metzger expressed enthusiasm about the company's transition to a commercial stage, emphasizing advances in their pipeline. Significant progress was made in the quarter, including updated data from trials involving their leading drug candidates, revumenib and axatilimab.

Revumenib, a selective menin inhibitor for treating relapsed or refractory (R/R) KMT2A-rearranged acute leukemia, has its New Drug Application (NDA) under Priority Review by the FDA. Originally set for a PDUFA action date of September 26, 2024, the review deadline has been extended to December 26, 2024, to allow the FDA additional time to review supplementary information provided by Syndax.

The company anticipates reporting topline data from the AUGMENT-101 pivotal trial for R/R mutant nucleophosmin (mNPM1) acute myeloid leukemia (AML) by the fourth quarter of 2024. Positive outcomes could lead to a supplemental NDA (sNDA) filing for revumenib in the first half of 2025.

Syndax is also conducting multiple Phase 1 combination trials of revumenib in mNPM1 and KMT2Ar acute leukemias. Notable trials include:
- BEAT AML, which combines revumenib with venetoclax and azacitidine for front-line AML patients. Positive data from this trial showed a 96% complete remission rate and the trial is expanding to validate the recommended Phase 2 dose.
- SAVE, exploring an all-oral combination of revumenib with venetoclax and decitabine/cedazuridine in R/R AML or mixed phenotype acute leukemias. Further data are expected in the second half of 2024.
- A trial combining revumenib with intensive chemotherapy for newly diagnosed mNPM1 or KMT2Ar acute leukemias. This Phase 1 trial aims to identify the recommended Phase 2 dose.

Additionally, Syndax plans to initiate a pivotal trial of revumenib in combination with venetoclax and azacitidine by the end of 2024 for newly diagnosed patients unfit for intensive chemotherapy.

Updated data from the AUGMENT-102 trial, which combines revumenib with fludarabine and cytarabine for R/R acute leukemias, was presented recently. The treatment achieved a 52% complete remission rate in patients with R/R mNPM1, NUP98-rearranged, or KMT2Ar acute leukemia.

The company has also progressed to the Phase 1b portion of its proof-of-concept trial of revumenib in patients with R/R metastatic microsatellite stable colorectal cancer based on promising initial data.

Regarding axatilimab, an anti-CSF-1R antibody for chronic graft-versus-host disease (GVHD), its Biologics License Application (BLA) is under FDA Priority Review, with a PDUFA action date of August 28, 2024. Additionally, a 26-week Phase 2 trial of axatilimab for idiopathic pulmonary fibrosis (IPF) is ongoing. Partner Incyte plans to start two combination trials with axatilimab in the latter half of 2024.

During the second quarter of 2024, Syndax experienced an increase in research and development expenses to $48.7 million, driven by higher clinical development and pre-commercial manufacturing costs. Similarly, selling, general, and administrative expenses rose to $29.1 million due to increased pre-commercialization activities.

Syndax reported a net loss of $68.1 million for the quarter, compared to a loss of $44.6 million in the same period the previous year. Despite these losses, the company believes it has sufficient capital to sustain its operations through 2026.

In May 2024, Syndax appointed Dr. Aleksandra Rizo to its Board of Directors, bringing her extensive clinical development experience to the company.

Looking ahead, the company expects third-quarter research and development expenses to be between $70 and $75 million, with total operating expenses ranging from $105 to $110 million. For the full year 2024, research and development expenses are projected at $240 to $260 million, while total operating expenses are expected to be $355 to $375 million.

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