Syndax Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Clinical and Business Update
– Announced positive topline results from the pivotal AGAVE-201 trial of axatilimab in cGVHD –
– Topline data from the pivotal AUGMENT-101 trial of revumenib in KMT2Ar acute leukemia on track for the third quarter of 2023 –
– Two U.S. registrational filings expected by the end of 2023 –
– Company to host conference call today at 4:30 p.m. ET –
WALTHAM, Mass., Aug. 3, 2023 /PRNewswire/ -- Syndax Pharmaceuticals Inc. (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results for the quarter ended June 30, 2023, and provided a business update.
"On the heels of recently reported positive data from our pivotal AGAVE-201 trial of axatilimab in chronic graft-versus-host disease, we remain on track to achieve several additional important milestones for both of our programs in what is proving to be a transformational year for Syndax," said Michael A. Metzger, Chief Executive Officer. "The AGAVE-201 data underscore axatilimab's ability to provide meaningful benefit to patients suffering from cGVHD, and we are working with our partners at Incyte to potentially submit a BLA filing by the end of 2023."
Mr. Metzger added, "Additionally, we remain on track to report topline pivotal data from the KMT2Ar cohorts of the Phase 2 AUGMENT-101 trial of revumenib for acute leukemias this quarter, followed by a potential NDA filing by the end of this year. We continue to be focused on executing our robust clinical development plans for both axatilimab and revumenib to fully realize their potential as best-in-class medicines."
Recent Pipeline Progress and Anticipated Milestones
Second Quarter 2023 Financial Results
As of June 30, 2023, Syndax had cash, cash equivalents, and short- and long-term investments of $418.3 million and 69.7 million common shares and prefunded warrants outstanding.
Second quarter 2023 research and development expenses increased to $34.8 million from $29.7 million for the comparable prior year period. The increase in research and development expenses was primarily due to increased employee-related expenses, professional fees and clinical expenses, partially offset by decreased manufacturing activities.
Second quarter 2023 general and administrative expenses increased to $14.9 million from $8.0 million for the comparable prior year period. The increase is primarily due to employee-related expenses and professional fees.
For the three months ended June 30, 2023, Syndax reported a net loss attributable to common stockholders of $44.6 million, or $0.64 per share, compared to a net loss attributable to common stockholders of $37.6 million, or $0.62 per share, for the comparable prior year period.
Financial Update and Guidance
For the third quarter of 2023, the Company expects research and development expenses to be $39 to $43 million and total operating expenses to be $57 to $62 million. For the full year of 2023, the Company continues to expect research and development expenses to be $160 to $175 million and total operating expenses to be $225 to $240 million.
Conference Call and Webcast
In connection with the earnings release, Syndax's management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Thursday, August 3, 2023.
The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website. Alternatively, the conference call may be accessed through the following:
Conference ID: SNDX2Q23
For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company's website at www.syndax.com approximately 24 hours after the conference call and will be available for 90 days following the call.
Syndax is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include revumenib, a highly selective inhibitor of the Menin–KMT2A binding interaction, and axatilimab, a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. For more information, please visit www.syndax.com or follow the Company on Twitter and LinkedIn.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials, the reporting of clinical data for Syndax's product candidates, the potential use of our product candidates to treat various cancer indications and fibrotic diseases, and Syndax's expected third quarter and full year research and development expenses, and expected third quarter and full year total operating expenses. Many factors may cause differences between current expectations and actual results, including: unexpected safety or efficacy data observed during preclinical or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; failure of Syndax's collaborators to support or advance collaborations or product candidates; and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
SOURCE Syndax Pharmaceuticals, Inc.
Company Codes: NASDAQ-NMS:SNDX