Financial Performance - Syndax reported $20.0 million in net revenue from Revuforj in the first quarter of 2025, marking the first full quarter of its U.S. launch[5] - Niktimvo generated $13.6 million in net revenue in its first partial quarter of launch, with Syndax recording a $0.2 million share of the net commercial loss[10] - Product revenue for the first quarter of 2025 was $20,042,000, compared to $0 in the same period of 2024[34] - Net loss for Q1 2025 was $84,846,000, compared to a net loss of $72,400,000 in Q1 2024, indicating a 17.2% increase in losses[34] - Basic loss per share attributable to common stockholders was $0.98 in Q1 2025, compared to $0.85 in Q1 2024, reflecting a 15.3% increase[34] Expenses - Research and development expenses increased to $61.6 million in Q1 2025, up from $56.5 million in the same period last year, primarily due to axatilimab-related costs[12] - Selling, general and administrative expenses rose to $41.0 million in Q1 2025, compared to $23.0 million in the prior year, driven by increased employee-related expenses[13] - The company expects R&D expenses for Q2 2025 to be between $70 million and $75 million, with total expenses (R&D plus SG&A) projected at $110 million to $115 million[15] - Total operating expenses increased to $103,799,000 in Q1 2025, up from $79,514,000 in Q1 2024, representing a 30.5% increase[34] - Research and development expenses rose to $61,636,000 in Q1 2025, compared to $56,492,000 in Q1 2024, marking an increase of 9.5%[34] - Selling, general and administrative expenses increased significantly to $41,031,000 in Q1 2025 from $23,022,000 in Q1 2024, a rise of 78.3%[34] Cash and Assets - The company had cash, cash equivalents, and investments totaling $602.1 million as of March 31, 2025, expected to fund operations to profitability[9] - Cash, cash equivalents, and investments decreased to $602,135,000 as of March 31, 2025, down from $692,404,000 as of December 31, 2024, a decline of 13.0%[32] - Total assets decreased to $640,707,000 as of March 31, 2025, compared to $724,816,000 as of December 31, 2024, a reduction of 11.6%[32] - Total stockholders' equity fell to $215,059,000 as of March 31, 2025, down from $288,124,000 as of December 31, 2024, a decrease of 25.3%[32] - Common stock outstanding increased to 86,047,032 shares as of March 31, 2025, compared to 85,694,443 shares as of December 31, 2024[32] Product Development and Market Opportunities - Syndax plans to initiate multiple trials of revumenib in combination with standard care regimens for newly diagnosed acute leukemia patients starting in the second half of 2025[8] - The company submitted a supplemental New Drug Application (sNDA) for revumenib for the treatment of R/R mNPM1 AML in April 2025, seeking Priority Review[5] - Revuforj and Niktimvo are positioned to unlock multi-billion-dollar opportunities in their respective markets, supported by strong clinical data and ongoing trials[3]

Financial Performance - Syndax Pharmaceuticals reported $20.0 million in net revenue from Revuforj® (revumenib) in the first full quarter of its launch [1][4] - Niktimvo™ (axatilimab-csfr) generated $13.6 million in net revenue in its first partial quarter of launch, as reported by Incyte [1][8] - The company had cash, cash equivalents, and investments totaling $602.1 million as of March 31, 2025, which is expected to fund operations until profitability [1][7] Business Developments - The company submitted a supplemental New Drug Application (sNDA) for revumenib for the treatment of relapsed or refractory (R/R) mutant NPM1 acute myeloid leukemia (AML) [1][4] - A pivotal frontline trial of revumenib in combination with venetoclax and azacitidine for mNPM1 and KMT2Ar AML has been initiated [1][4] - Multiple ongoing trials are evaluating revumenib in various combinations and settings, including a Phase 1 trial showing a 100% overall response rate in newly diagnosed mNPM1 or KMT2Ar AML patients [4][5] Research and Development - Research and development expenses for the first quarter of 2025 increased to $61.6 million from $56.5 million in the prior year, driven by costs related to axatilimab and ongoing clinical trials [10] - Selling, general, and administrative expenses rose to $41.0 million from $23.0 million, primarily due to increased employee-related expenses and marketing efforts for Revuforj [11] - The company plans to initiate multiple trials of revumenib in combination with standard care regimens for newly diagnosed acute leukemia patients starting in the second half of 2025 [5][10] Future Outlook - For the second quarter of 2025, the company expects research and development expenses to be between $70 million and $75 million, with total operating expenses projected to be between $110 million and $115 million [13] - The company anticipates that its current cash position, along with expected product revenue, will enable it to reach profitability [14]

Conference ID: Syndax1Q25 Domestic Dial-in Number: 800-590-8290 International Dial-in Number: 240-690-8800 Live webcast: https://sndx-1q25.open-exchange.net/registration NEW YORK, April 28, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it will report its first quarter 2025 financial results and provide a business update on Monday, May 5, 2025. In connection with the earn ...

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 (SNDX) Q4 2024 Earnings Call March 03, 2025 06:57 PM ET Company Participants Sharon Klahre - Vice President of Investor Relations & CommunicationsMichael Metzger - CEO & DirectorSteve Closter - CCONeil Gallagher - President, Head of Research & DevelopmentKeith Goldan - Chief Financial OfficerBradley Canino - DirectorKelly Shi - Senior Vice PresidentYigal Nochomovitz - DirectorDavid Dai - DirectorGeorge Farmer - Managing DirectorAnjali Ganguli - Chief Strategy OfficerErik Lavington - E ...

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 ...