Core Insights - Syndax is a commercial stage company focused on oncology with two commercial stage assets launched in the last year [1] - Revuforj is a first-in-class selective menin inhibitor indicated for KMT2A acute leukemia, which represents about 10% of the overall population of AML and ALL [1]

Summary of Syndax Pharmaceuticals Conference Call Company Overview - **Company**: Syndax Pharmaceuticals - **Focus**: Oncology, specifically acute leukemia and chronic graft-versus-host disease (GVHD) - **Key Products**: - **Revumenib**: First-in-class selective menin inhibitor for acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) - **Niktimba**: CSF1R antibody for chronic GVHD Key Points and Arguments Product Launch and Market Opportunity - **Revumenib** targets KMT2A acute leukemia (10% of AML and ALL) and NPM1 (30-35% of AML), representing a combined market opportunity of approximately **$5 billion** [4][3] - **Niktimba** launched in February 2025 for chronic GVHD, also showing strong initial performance [4][4] Clinical Performance and Feedback - Over **750 patients** treated with Revumenib, with **one-third** progressing to transplantation [9][11] - Positive physician feedback on Revumenib's efficacy and tolerability, with expectations of **70-80%** of patients potentially returning to maintenance therapy post-transplant [13][17] - Current average duration of therapy for Revumenib is projected at **4-6 months**, expected to extend to **6-12 months** as more patients return to maintenance [24][25] Regulatory and Safety Considerations - Recent FDA update includes a black box warning for Torsades de Pointes; however, physicians remain confident in managing this risk due to existing experience with similar drugs [26][28] - Efficacy remains the primary concern for physicians, overshadowing safety warnings [30][29] Future Clinical Development - Plans to initiate frontline trials for Revumenib, focusing on both unfit and fit patient populations [38][42] - Collaboration with HOVON to expedite phase three trials, aiming for rapid enrollment and high-quality data [50][52] - Anticipated data readouts from ongoing studies, including the **MAXIMYRE** trial for Niktimba in idiopathic pulmonary fibrosis (IPF), expected in late 2026 [65][66] Financial Outlook - Niktimba has generated approximately **$46 million** in its second full quarter, with a strong adoption rate and nearly **100%** payer coverage [58][59] - Syndax holds about **$456 million** in cash, positioning the company well for future growth and profitability [68][68] Upcoming Catalysts - Key upcoming events include data presentations at ASH, potential trial readouts for Niktimba in IPF, and ongoing developments in frontline trials for Revumenib [67][68] Additional Important Insights - The company is focused on maintaining a stable expense base while driving towards profitability, leveraging its first-mover advantage in the menin inhibitor space [68][68] - The potential for Revumenib to transform treatment paradigms in AML is emphasized, particularly in combination therapies [39][40]

Core Insights - The article emphasizes the importance of enabling Javascript and cookies in browsers to prevent access issues [1] Group 1 - The article suggests that users may face blocks if they have an ad-blocker enabled [1]

Core Viewpoint - The article discusses the investment position in SNDX, indicating a beneficial long position held by the analyst, which reflects confidence in the company's future performance [1]. Group 1 - The analyst has a long position in SNDX shares, which may suggest a positive outlook on the company's stock performance [1]. - The article emphasizes that the opinions expressed are personal and not influenced by any business relationships with the company mentioned [1]. Group 2 - There is a clear distinction made that the commentary provided does not constitute personalized investment advice, highlighting the importance of individual due diligence [2]. - The article notes that past performance is not indicative of future results, reinforcing the need for cautious investment strategies [3].

Financial Data and Key Metrics Changes - Syndax reported total revenue of $45.9 million for Q3 2025, reflecting a strong 21% growth over the prior quarter [4] - Revyforge net revenue was $32 million in Q3, up 12% from the prior quarter, with a 25% increase in total prescriptions and new patient starts [5][11] - Nictimvo net revenue reached $45.8 million in Q3, marking a 27% increase over the prior quarter [9][19] Business Line Data and Key Metrics Changes - Revyforge has become the standard of care for relapsed refractory KMT2A, with approximately 50% of usage in the second line [5] - Nictimvo is annualizing at nearly $200 million within the first eight months of launch, tracking in line with first-year sales of similar therapies [9] - The approval of Revyforge for relapsed refractory NPM1 mutated AML has expanded the addressable patient population significantly [6][15] Market Data and Key Metrics Changes - The total addressable U.S. population for Revyforge has increased from approximately 2,000 to 6,500 patients with the new indication [15] - Nictimvo is targeting a market opportunity of approximately $2 billion, with 6,500 patients in the U.S. requiring three or more lines of therapy [21] Company Strategy and Development Direction - The company aims to expand Revyforge and Nictimvo into the frontline setting, unlocking a combined market opportunity exceeding $10 billion [10] - Syndax is focused on executing pivotal trials for menin inhibitors, with Evolve 2 being the first frontline trial to start enrolling patients [10][28] - The company is leveraging its strong commercial foundation and prescriber relationships to drive growth in both product lines [16][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reaching profitability, citing strong performance from both Revyforge and Nictimvo [38] - The company anticipates that the average duration of therapy for KMT2A patients will increase to six to twelve months in 2026 as treatment patterns mature [14][44] - Management highlighted the positive feedback from healthcare providers regarding the efficacy and tolerability of both Revyforge and Nictimvo [20][22] Other Important Information - Syndax has a strong financial position with $456 million in cash equivalents and investments as of September 30, 2025 [38] - The company has received three FDA approvals and is positioned for sustained growth with its current product offerings [39] Q&A Session Summary Question: How has Revyforge's place in lines of therapy evolved? - Management noted that about 70% of Revyforge's business is in the second or third line, a shift from clinical trials where patients were typically in third or fourth line [41][42] Question: What factors will help narrow the duration of therapy range for 2026? - Management indicated that the mix of KMT2A and NPM1 patients will influence the duration of therapy, with expectations for longer durations as more patients return from transplant [44][45] Question: What is the maintenance restart rate for patients who started Revyforge during the launch? - The restart rate has increased to about 35%-40%, with expectations for further growth as more patients return from transplant [46][47] Question: How will revenue per prescription evolve with the inclusion of more NPM1 patients? - Management does not expect significant changes in average revenue per prescription as NPM1 patients are integrated into the prescribing base [49] Question: What has been the impact of the NCCN guidelines on the NPM1 launch? - Management reported strong awareness and excitement among healthcare providers, setting a positive trajectory for the NPM1 launch [54][56]

Financial Performance & Growth - Syndax reported net product revenue of $32 million in 3Q25[3], representing a 25% quarter-over-quarter (q/q) growth in total prescriptions (TRx)[3, 4] - Collaboration revenue reached $139 million in 3Q25, with $13.9 million attributed to Syndax[3] - Niktimvo net revenue was $45.8 million in 3Q25, reflecting a 27% q/q growth[13] and collaboration revenue to Syndax was $13.9 million, up 48% q/q[13] - As of September 30, 2025, Syndax had $456 million in cash and equivalents[39] Revuforj Highlights - Revuforj achieved approximately 2,200 cumulative total prescriptions since launch[4] - Approximately 33% of KMT2A patients proceed to hematopoietic stem cell transplantation (HSCT)[4] - Approximately 70% of KMT2A use is in the 2L/3L setting[4] - Approximately 35-40% of KMT2A patients resume Revuforj post-HSCT[4] - Revuforj is positioned to potentially capture 40-45% of the addressable AML population[9] Niktimvo Highlights - Approximately 90% of patients who started Niktimvo treatment in Q1 remained on treatment[14] - Approximately 80% of U S bone marrow transplant centers have ordered Niktimvo[14] Market Opportunity - Revuforj's second indication unlocks a $2 billion+ U S market opportunity in relapsed/refractory (R/R) acute leukemia alone[6] - The initial Niktimvo indication represents a $2 billion U S market opportunity, with potential for expansion[15]

Financial Performance - Revuforj achieved $32.0 million in net revenue in Q3 2025, a 12% increase from Q2 2025, with approximately 850 prescriptions, a 25% increase from the previous quarter [83]. - Niktimvo generated $45.8 million in net revenue in Q3 2025, representing a 27% increase over Q2 2025, with the company's share of collaboration revenue at $13.9 million [87]. - For the nine months ended September 30, 2025, the company reported a net loss of $217.4 million, compared to a net loss of $224.6 million for the same period in 2024 [82]. - Total revenues increased to $45.9 million for the three months and $103.6 million for the nine months ended September 30, 2025, compared to $12.5 million and $16.0 million in the prior year [104]. - Net loss for the three months ended September 30, 2025, was $60.7 million, compared to a net loss of $84.1 million in the prior year [104]. Cash and Investments - As of September 30, 2025, the company had an accumulated deficit of $1.4 billion and cash, cash equivalents, and investments totaling $456.1 million [82]. - The company has cash and cash equivalents of $116.8 million and short and long-term investments totaling $339.3 million as of September 30, 2025 [134]. - Net cash used in operating activities increased to $253.5 million for the nine months ended September 30, 2025, from $217.5 million in the prior year [117]. - Net cash provided by investing activities was $208.5 million for the nine months ended September 30, 2025, compared to $49.2 million in the prior year [118][119]. - The company entered into a sales agreement for an At-the-Market Offering Program with the potential to raise up to $200 million, with $157.9 million available as of September 30, 2025 [131]. Expenses - Total operating expenses were $103.3 million for the three months and $314.2 million for the nine months ended September 30, 2025, an increase of $1.2 million and $54.9 million, respectively, from the prior year [104]. - Research and development expenses are expected to grow as the company continues to focus on advancing its clinical development programs [92]. - Selling, general and administrative expenses increased by $13.8 million for the three months and $46.6 million for the nine months ended September 30, 2025, primarily due to commercial-related costs [110]. - Research and development expenses decreased by $14.7 million for the three months ended September 30, 2025, but increased by $4.0 million for the nine months compared to the prior year [109][110]. Regulatory and Development Updates - Revuforj received FDA approval on October 24, 2025, for treating R/R AML with a susceptible NPM1 mutation, making it the first FDA-approved therapy for both R/R AML with an NPM1 mutation and R/R acute leukemia with a KMT2A translocation [83]. - Ongoing trials for revumenib include pivotal Phase 3 and Phase 1/2 studies evaluating its efficacy in various acute leukemia subtypes [83][84]. - Axatilimab is in development for newly diagnosed cGVHD patients and idiopathic pulmonary fibrosis, with ongoing trials expected to complete enrollment by the end of 2025 [87]. Future Outlook and Risks - The company anticipates stable selling, general, and administrative expenses in the coming years as it supports the commercialization of Revuforj and Niktimvo [96]. - The company expects to support future cash needs through equity offerings, debt financings, and collaboration arrangements, with no committed external source of liquidity [125]. - The company is subject to risks including unfavorable interest rates and geopolitical unrest, which could impact operations and financing [132]. - The company faces challenges in obtaining regulatory approvals and protecting intellectual property rights, which are common risks in the pharmaceutical industry [133].

Financial Performance - Total revenue for Q3 2025 was $45.9 million, representing a 21% growth over Q2 2025[1] - Revuforj net revenue was $32.0 million, with total prescriptions increasing by 25% over Q2 2025[1][4] - Niktimvo net revenue was $45.8 million, reflecting a 27% increase over Q2 2025, with Syndax's share of collaboration revenue at $13.9 million[1][9] - Total revenues for the three months ended September 30, 2025, were $45.871 million, compared to $12.5 million for the same period in 2024, representing a significant increase[32] - Product revenue for the nine months ended September 30, 2025, was $80.649 million, while collaboration revenue was $22.975 million, indicating strong performance in both areas[32] Expenses - Research and development expenses decreased to $56.3 million from $71.0 million year-over-year, primarily due to a prior milestone payment[11] - Selling, general and administrative expenses increased to $44.9 million from $31.1 million year-over-year, driven by higher commercial costs[12] - Total operating expenses for the three months ended September 30, 2025, were $103.297 million, slightly higher than $102.077 million for the same period in 2024[32] - For the full year 2025, the company expects total expenses to be between $380 million and $385 million, excluding an estimated $45 million in non-cash stock compensation[14] Net Loss - The net loss attributable to common stockholders for Q3 2025 was $60.7 million, or $0.70 per share, compared to a loss of $84.1 million, or $0.98 per share, in the prior year[13] - The net loss for the three months ended September 30, 2025, was $60.715 million, compared to a net loss of $84.126 million for the same period in 2024, showing an improvement[32] - Basic loss per share attributable to common stockholders for the three months ended September 30, 2025, was $0.70, down from $0.98 in the same period of 2024[32] - The company reported a loss from operations of $57.426 million for the three months ended September 30, 2025, compared to a loss of $89.577 million for the same period in 2024, indicating operational improvements[32] Cash and Equity - As of September 30, 2025, the company had $456.1 million in cash, cash equivalents, and investments[8] - Total stockholders' equity as of September 30, 2025, was $115.430 million, a decrease from $288.124 million as of December 31, 2024[30] - Cash, cash equivalents, and investments totaled $456.125 million as of September 30, 2025, down from $692.404 million as of December 31, 2024, indicating a reduction in liquidity[30] - Common stock outstanding increased to 86,905,343 shares as of September 30, 2025, from 85,694,443 shares as of December 31, 2024, reflecting ongoing equity financing activities[30] Product Development - Revuforj received FDA approval for R/R NPM1m AML on October 24, 2025, marking a significant milestone for the product[5] - The company is advancing multiple clinical trials for Revuforj and Niktimvo, aiming to unlock their multi-billion-dollar potential in various indications[3][19] - Research and development expenses for the nine months ended September 30, 2025, were $180.143 million, compared to $176.118 million for the same period in 2024, reflecting continued investment in product development[32]

Core Insights - Syndax Pharmaceuticals reported total revenue of $45.9 million for Q3 2025, marking a 21% increase compared to Q2 2025 [1] - The company achieved FDA approval for Revuforj on October 24, 2025, for the treatment of relapsed or refractory NPM1m acute myeloid leukemia (AML) [1][5] - Syndax has $456.1 million in cash and investments, which is expected to fund the company to profitability [1][8] Financial Performance - Revuforj generated $32.0 million in net revenue for Q3 2025, a 12% increase from Q2 2025, with total prescriptions rising by 25% [4][5] - Niktimvo reported $45.8 million in net revenue, with Syndax recording $13.9 million in collaboration revenue from this product [9][11] - The net loss attributable to common stockholders for Q3 2025 was $60.7 million, or $0.70 per share, an improvement from a net loss of $84.1 million, or $0.98 per share, in the same period last year [13][29] Business Highlights - Strong demand for Revuforj and Niktimvo resulted in over $75 million in combined net sales for the quarter [2] - Revuforj was included in the NCCN Guidelines for R/R NPM1m AML as a category 2A recommended treatment option [5] - The company is advancing multiple clinical trials for Revuforj and Niktimvo, targeting various indications and patient populations [10][18] Research and Development - Research and development expenses decreased to $56.3 million in Q3 2025 from $71.0 million in the prior year, primarily due to the absence of a milestone payment related to Niktimvo's approval [11] - Selling, general, and administrative expenses increased to $44.9 million from $31.1 million, driven by higher commercial costs associated with the launches of Revuforj and Niktimvo [12] Future Outlook - The company expects total operating expenses for 2025 to be between $380 million and $385 million, excluding an estimated $45 million in non-cash stock compensation [14] - Syndax anticipates that its current cash reserves, combined with expected product revenue, will enable it to reach profitability [15]

Core Insights - Syndax Pharmaceuticals will host an in-person investor event on December 8, 2025, at 7:00 a.m. ET during the ASH Annual Meeting to discuss data updates from its Revuforj and Niktimvo programs [1] Company Overview - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on innovative cancer therapies, with key products including 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 its pipeline and is conducting several clinical trials across various treatment stages [3]