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 ...

Financial Data and Key Metrics Changes - For Q4 2024, Syndax Pharmaceuticals reported $7.7 million in net revenue from Revuforj, marking the company's first quarter with product revenue [10][46] - Operating expenses for Q4 were $104 million, which included $65.5 million in research and development expenses and $37.7 million in selling, general, and administrative expenses [46] - The company maintained a strong financial position with $692.4 million in cash, equivalents, and investments at year-end [47] Business Line Data and Key Metrics Changes - Revuforj, the first-in-class menin inhibitor, launched in November 2024, has shown strong early demand with $7.7 million in net revenue from the first five weeks of sales [10][11] - Niktimvo, launched in January 2025 for chronic graft versus host disease, is expected to capture a significant portion of the $1.5 billion to $2 billion market for third-line or later chronic GVHD treatment in the US [32] Market Data and Key Metrics Changes - Approximately 33% of Tier 1 and Tier 2 accounts have ordered Revuforj, indicating strong early penetration in key treatment centers [21][22] - The company is seeing rapid inclusion of Revuforj in payer coverage, with 56% of commercially covered lives and 53% of all managed care lives having formal coverage policies in place [25] Company Strategy and Development Direction - The company aims to expand Revuforj's indication to include mutant NPM1 AML by filing a supplemental new drug application in the upcoming quarter [12] - Syndax is focused on building a robust pipeline in oncology, with plans to extend its products into earlier line indications and develop additional targeted therapies [99][100] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position for long-term growth, highlighting the strong market opportunities with Revuforj and Niktimvo [54] - The management team emphasized the importance of building a habit among physicians for prescribing Revuforj, which is expected to become the standard of care for KMT2A translocations [24][60] Other Important Information - The company received $350 million upfront from Royalty Pharma in exchange for a capped royalty on US net sales of Niktimvo, indicating the product's multi-billion-dollar potential [15] - The company expects R&D expenses for Q1 2025 to be between $65 million and $70 million, with total R&D plus SG&A expenses projected to be between $105 million and $110 million [48] Q&A Session Summary Question: Inventory levels and repeat prescribers for Revuforj - Management indicated that inventory levels are expected to remain stable at about two to three weeks, with revenue growth potentially increasing absolute inventory levels [62] - Approximately one-third of Tier 1 and Tier 2 accounts have ordered Revuforj, with most accounts having prescribed it more than once, indicating positive early adoption [65] Question: Activation of Tier 1/2 accounts and comparison to historic AML launches - Management expects continued activation of Tier 1 and Tier 2 accounts over the next 10 months, with a focus on the top 200 treatment centers [73] - The unique setup of Revuforj, including diagnostic testing for KMT2A patients, is expected to drive its adoption compared to other targeted therapies [78] Question: Off-label use and Expanded Access Program (EAP) - Anecdotal evidence suggests some off-label use of Revuforj, particularly in combination treatments, but specific numbers are not yet available [86] - The EAP remains lightly used, with no additional patients expected to transition from it at this time [87] Question: Future company vision and pipeline expansion - The company aims to build a larger pipeline in oncology and expects to have multiple commercial products by 2030, focusing on targeted therapies [100][101] Question: Safety feedback and physician experience with Revuforj - Feedback on Revuforj's safety profile has been positive, with comprehensive support provided to physicians through clinical nurse educators [110] Question: Gross to net adjustments and patient assistance programs - The gross to net adjustments for Revuforj are expected to remain tight due to the limited distribution channel, with a patient assistance program available for uninsured or underinsured patients [118][120] Question: Transplant dynamics and patient treatment pathways - Physicians are interested in getting patients to transplant, particularly for KMT2A, with expectations that many patients will return to maintenance therapy post-transplant [122]

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]