NEW YORK, April 02, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (NASDAQ:SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that Michael A. Metzger, Chief Executive Officer of Syndax, as well as members of the Syndax management team, will participate in a fireside chat at the Stifel 2025 Virtual Targeted Oncology Forum on Wednesday, April 9, 2025, at 10:30 a.m. ET. A live webcast of the fireside chat will be available in the Investor ...

Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) Q4 2024 Earnings Conference Call March 3, 2025 8:00 AM ET Company Participants Sharon Klahre - Head of IR Michael Metzger - CEO Steve Closter - CCO Neil Gallagher - President and Head of R&D Keith Goldan - CFO Anjali Ganguli - CSO Conference Call Participants Anupam Rama - JPMorgan Brad Canino - Stifel Peter Lawson - Barclays Chris Shibutani - Goldman Sachs Kelly Shi - Jefferies Michael Schmidt - Guggenheim Yigal Nochomovitz - Citi David Dai - UBS Justin Zelin - BT ...

Fourth Quarter & Full Year 2024 Financial Results Presentation / March 3, 2025 Forward-looking statements disclosure This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events, progress, timing or circumstances) are intended to identify forward-looking statements. All statements other than s ...

Company Performance - Syndax Pharmaceuticals reported a quarterly loss of $1.10 per share, slightly worse than the Zacks Consensus Estimate of a loss of $1.08, and compared to a loss of $1 per share a year ago, indicating a decline in performance [1] - The company posted revenues of $7.68 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 65.45%, while revenues were zero a year ago [2] - Over the last four quarters, Syndax has surpassed consensus EPS estimates three times, showing some volatility in earnings performance [2] Stock Movement and Outlook - Syndax shares have increased approximately 18.3% since the beginning of the year, outperforming the S&P 500's gain of 1.2% [3] - The future stock price movement will largely depend on management's commentary during the earnings call and the earnings outlook for the upcoming quarters [3][4] - Current consensus EPS estimate for the next quarter is -$1.14 on revenues of $8.1 million, and for the current fiscal year, it is -$4.25 on revenues of $71.56 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Syndax belongs, is currently ranked in the top 28% of over 250 Zacks industries, indicating a favorable industry outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Syndax's stock performance [5][6]

Financial Performance - Revuforj generated net product revenue of $7.7 million for the twelve months ended December 31, 2024, following its FDA approval on November 15, 2024[348]. - The company reported net losses of $318.8 million, $209.4 million, and $149.3 million for the years ended December 31, 2024, 2023, and 2022, respectively[344]. - Total revenue for the year ended December 31, 2024, was $23.68 million, an increase of $23.68 million compared to 2023[373]. - Net product revenue from sales of Revuforj in the United States was $7.68 million, with milestone revenue of $16 million achieved through collaboration agreements[374][375]. - Total operating expenses for 2024 were $363.35 million, an increase of $133.4 million from 2023[373]. - As of December 31, 2024, the company had an accumulated deficit of $1.2 billion and anticipates continuing to incur significant losses for at least the next several years[1]. Cash and Investments - As of December 31, 2024, the company had cash, cash equivalents, and investments totaling $692.4 million[344]. - Net cash used in operating activities for the year ended December 31, 2024, was $274.9 million, primarily due to a net loss of $318.8 million adjusted for non-cash items[4]. - Net cash provided by financing activities for the year ended December 31, 2024, was $353.4 million, mainly from proceeds of $343.7 million from the Royalty Pharma Purchase and Sale agreement[6]. - Net cash provided by investing activities for the year ended December 31, 2024, was $219.8 million, resulting from $337.3 million in proceeds from the maturities of available-for-sale marketable securities[5]. - The company had cash, cash equivalents, and short-term and long-term investments totaling $692.4 million as of December 31, 2024[9]. - The company anticipates needing additional capital to fund operations, which may lead to dilution of existing stockholders' ownership interests[1]. Expenses and Future Projections - Research and development expenses are expected to continue to grow significantly as the company advances its product candidates[356]. - Selling, general and administrative expenses are anticipated to increase as the company expands its workforce to support research and commercialization efforts[360]. - Research and development expenses increased by $78.6 million to $241.65 million in 2024, primarily due to costs related to Revumenib and Axatilimab[377]. - Selling, general and administrative expenses rose by $54 million to $120.88 million, driven by increased commercial readiness and personnel costs[378]. - The company anticipates future capital requirements will depend on clinical trial outcomes, regulatory approvals, and market acceptance of product candidates[388]. Tax and Regulatory Matters - The company had federal and state tax net operating loss carryforwards of approximately $181.0 million and $97.5 million, respectively, as of December 31, 2024[7]. - The company recorded a valuation allowance on all deferred tax assets, including those related to net operating loss and research and development tax credit carryforwards[10]. Product Development and Collaborations - The company plans to submit a supplemental New Drug Application for revumenib in Q2 2025 for the treatment of R/R acute myeloid leukemia[344]. - The company is exploring the use of revumenib in solid tumors, specifically metastatic colorectal cancer[344]. - The company recognized $3.5 million in milestone revenue in Q2 2024 from the Eddingpharm license agreement and $12.5 million in Q3 2024 from the Incyte Collaboration Agreement[353]. - A purchase and sale agreement with Royalty Pharma was executed for $350 million, granting rights to receive 13.8% of quarterly net sales of Niktimvo[384]. - The company has not generated substantial product revenue to date, relying on equity offerings and collaborations for financing[388].

Exhibit 99.1 Syndax Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update • $7.7 million in Revuforj ® (revumenib) net product revenue in initial five weeks of launch – approximately one-third of the net revenue represents inventory at specialty pharmacies and specialty distributors and the remainder represents patient demand. Revuforj was launched in the U.S. in late November 2024, following the FDA's approval on November 15, 2024 for the treatment of relapsed or refracto ...

Core Insights - Syndax Pharmaceuticals reported a strong start with the U.S. launch of Revuforj, achieving $7.7 million in net product revenue in the initial five weeks, indicating high patient demand and broad prescribing [1][4][10] - The company launched Niktimvo™ in the U.S. in late January 2025, in partnership with Incyte, expanding its product offerings in the oncology space [1][6] - Syndax expects to file a supplemental NDA for revumenib in relapsed/refractory mNPM1 AML in Q2 2025, based on positive data from the AUGMENT-101 trial [1][4][19] - The company has $692.4 million in cash and investments, which is expected to fund operations until profitability [1][10][15] Business Highlights - Revuforj (revumenib) generated $7.7 million in net product revenue during its first partial quarter of launch, with one-third attributed to inventory at specialty pharmacies [4][10] - Revumenib was included in the NCCN Clinical Practice Guidelines for acute myeloid leukemia and acute lymphoblastic leukemia as a category 2A recommendation [4] - The primary endpoint was met in the AUGMENT-101 trial, with 26% of patients achieving complete remission or partial hematological recovery [4][19] - Ongoing trials for revumenib include combinations with venetoclax and azacitidine, showing promising results in various patient populations [8][19] Financial Performance - For Q4 2024, research and development expenses increased to $65.5 million from $55.1 million year-over-year, driven by clinical and pre-commercial manufacturing costs [11] - Selling, general, and administrative expenses rose to $37.7 million in Q4 2024, reflecting increased costs related to the commercial launch of Revuforj [12] - The net loss attributable to common stockholders for Q4 2024 was $94.2 million, compared to a loss of $72.5 million in the same period the previous year [13] - The company expects R&D expenses for Q1 2025 to be between $65 million and $70 million, with total operating expenses projected to be $105 million to $110 million [14] Future Outlook - Syndax plans to initiate multiple trials for revumenib in combination with standard care regimens for newly diagnosed acute leukemia patients starting in the second half of 2025 [8] - The company is also evaluating revumenib in patients with relapsed metastatic colorectal cancer [8] - The anticipated filing for revumenib in R/R mNPM1 AML and ongoing trials position Syndax to capitalize on significant market opportunities in oncology [1][4][19]

Core Insights - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing innovative cancer therapies [2] - The company has an FDA-approved pipeline that includes Revuforj (revumenib), a menin inhibitor, and Niktimvo™ (axatilimab-csfr), a monoclonal antibody targeting the CSF-1 receptor [2] - Syndax is committed to advancing cancer care through its clinical trials and innovative treatments [2] Upcoming Events - Syndax's CEO and management team will participate in investor conferences, including the TD Cowen 45th Annual Health Care Conference on March 4, 2025, and the Barclays 27th Annual Global Healthcare Conference on March 13, 2025 [3] - Live webcasts of these events will be available on the company's website, with replays accessible for a limited time [1][3]

Core Viewpoint - Syndax Pharmaceuticals will report its fourth quarter and full year 2024 financial results on March 3, 2025, along with a business update [1] Financial Results Announcement - The earnings release will be followed by a conference call and live audio webcast at 8:00 a.m. ET on the same day [2] - Access to the live audio webcast and slides will be available on the Company's website, with a replay accessible for 90 days post-call [2] Company Overview - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing innovative cancer therapies [3] - Key products in the pipeline include Revuforj (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody targeting the CSF-1 receptor [3] - The company is committed to advancing cancer care through various clinical trials [3]

Core Insights - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing innovative cancer therapies [2] - The company has an FDA-approved pipeline that includes Revuforj® (revumenib) and Niktimvo™ (axatilimab-csfr) [2] - Syndax is committed to advancing cancer care through ongoing clinical trials [2] Upcoming Events - Syndax's CEO and management team will participate in the Guggenheim SMID Cap Biotech Conference on February 6, 2025, at 10:30 a.m. ET [4] - The company will also be featured in Citi's 2025 Virtual Oncology Leadership Summit on February 19, 2025, at 9:00 a.m. ET [4] - Live webcasts of these events will be available on the company's website [1]