Syndax Pharmaceuticals (NasdaqGS:SNDX) FY Conference September 08, 2025 09:00 AM ET Company ParticipantsArabella Ng - Equity Research AssociateMichael Metzger - CEO & DirectorArabella NgHello everyone, and thank you for joining the HC Wainwright 27th Annual Global Investment Conference. My name is Arabella, and I'm an Associate on the Equity Research Team at HC Wainwright. HC Wainwright is a full-service investment bank dedicated to providing corporate finance, strategic advisory, and related services to pu ...

Group 1 - The session is part of Citi's Biopharma Back-to-School Summit, indicating a focus on the biopharmaceutical industry [1] - Senior management from Syndax Pharmaceuticals is present, including the CFO, CCO, and Head of Research and Development, highlighting the company's leadership engagement [2]

Summary of Syndax Pharmaceuticals (SNDX) Conference Call - September 02, 2025 Company Overview - **Company**: Syndax Pharmaceuticals - **Products**: Revuforj (for KMT2A-rearranged acute leukemia) and Ictimo (for chronic graft-versus-host disease, cGVHD) - **Recent Achievements**: Two rapid approvals in succession, with a focus on addressing high unmet medical needs in oncology Key Points on Revuforj - **Launch Performance**: Revuforj has seen a **43% growth in net sales** with over **$50 million** generated since launch, treating over **500 patients** [3][5] - **Market Dynamics**: - Targeting **KMT2A-rearranged patients**, with a total addressable market (TAM) of **2,000 new patients annually** [5][6] - Currently treating **25%** of the available market, with expectations to increase to **50%** by year-end [5][6] - **Treatment Duration**: Average treatment duration expected to increase from **4-6 months** to **9 months** as more patients are treated earlier in their disease progression [9][10] - **Patient Demographics**: Shift from treating late-line patients to earlier-line patients, with **70%** of current patients being in the second or third line of treatment [7][12] - **Transplant Dynamics**: Approximately **33%** of patients are expected to go for transplant, higher than the **25%** seen in clinical trials [7][8] Upcoming Regulatory Milestones - **sNDA Submission**: An sNDA for Revuforj is under review with a PDUFA date of **October 25, 2025** [21][22] - **Market Expansion**: The NPM1-mutated patient market is larger than KMT2A, with an estimated **4,500 patients** [23][24] Key Points on Ictimo - **Launch Success**: Ictimo has generated nearly **$50 million** in sales in its first full quarter, with **700 patients** treated [42][43] - **Patient Retention**: **80-90%** of patients are remaining on the drug, indicating strong tolerability [42] - **Market Coverage**: Over **80%** of transplant centers have utilized Ictimo, with a majority using it multiple times [43][44] - **Partnership with Incyte**: Co-promotion with Incyte has been efficient, leveraging their existing infrastructure [44] Future Development Plans - **Subcutaneous Formulation**: Development of a subcutaneous formulation for Ictimo is underway, which could enhance patient convenience [48] - **Clinical Trials**: Ongoing studies in combination with dexamethasone and Jakafi for earlier lines of therapy in cGVHD [49][50] Financial Outlook - **Profitability Goals**: Syndax aims to reach profitability without needing additional financing, with operating expenses expected to remain flat through **2025** [61][62] - **Collaboration Revenue**: Ictimo is already profitable on a contribution profit basis, with **$9 million** in collaboration revenue reported [61] Competitive Landscape - **Market Position**: Syndax is positioned as the only approved menin inhibitor, with a focus on maintaining a competitive edge through efficacy and multiple indications [30][40] Conclusion - **Strategic Focus**: Syndax is concentrating on successfully commercializing Revuforj and Ictimo, advancing clinical development, and achieving profitability before considering new product investments [68][69]

Core Insights - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on innovative cancer therapies [2] - The company has FDA-approved products in its pipeline, including Revuforj (revumenib) and Niktimvo™ (axatilimab-csfr) [2] - Syndax is actively participating in upcoming investor conferences to engage with stakeholders [1][3] Company Overview - Syndax Pharmaceuticals is dedicated to advancing cancer care through its innovative therapies [2] - The company is conducting several clinical trials to maximize the potential of its product pipeline [2] Upcoming Events - Syndax's CEO and management team will participate in Citi's 2025 BioPharma Back to School Conference on September 2, 2025 [3] - The company will also present at H.C. Wainwright's 27th Annual Global Investment Conference on September 8, 2025 [3]

Core Viewpoint - Syndax Pharmaceuticals (SNDX) has shown a significant price increase of 45.4% over the past four weeks, with a mean price target of $34.75 indicating a potential upside of 158.4% from the current price of $13.45 [1] Price Targets and Estimates - The mean estimate consists of 12 short-term price targets with a standard deviation of $12.74, where the lowest estimate is $17.00 (26.4% increase) and the highest is $56.00 (316.4% increase) [2] - A low standard deviation among price targets suggests a high degree of agreement among analysts regarding the stock's price movement [9] Analyst Sentiment and Earnings Estimates - Analysts are optimistic about SNDX's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which has shown a correlation with near-term stock price movements [11] - The Zacks Consensus Estimate for the current year has increased by 11.9% over the past month, with five estimates revised upward and no negative revisions [12] - SNDX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] Caution on Price Targets - While price targets are often sought after by investors, they can be misleading and should not be the sole basis for investment decisions [3][7][10] - Analysts may set overly optimistic price targets due to business incentives, which can inflate expectations [8]

Group 1 - The article expresses a beneficial long position in the shares of SNDX, indicating a positive outlook on the company's stock performance [1] - The author emphasizes that the opinions presented are personal and not influenced by any business relationships with the companies mentioned [1] - The article does not provide personalized investment advice, urging readers to conduct their own due diligence before making investment decisions [2][3] Group 2 - The commentary highlights that past performance is not indicative of future results, which is a common disclaimer in investment analysis [3] - It is noted that the views expressed may not reflect those of the platform as a whole, indicating a diversity of opinions among analysts [3] - The article clarifies that the analysts involved may not be licensed or certified, which is important for readers to consider when interpreting the analysis [3]

Group 1 - The article highlights Syndax Pharmaceuticals (NASDAQ: SNDX) as a focus for investment opportunities in the biotech sector, particularly in oncology [1] - The previous assessment of Syndax Pharmaceuticals indicated that the company is "down, but not out," suggesting potential for recovery and growth [1] - The Biotech Forum offers a model portfolio featuring 12-20 high upside biotech stocks, along with live discussions and weekly updates on market conditions [1] Group 2 - The article emphasizes the importance of covered call opportunities in the biotech market, indicating a trend among investors [1] - The investing group led by Bret provides insights and trading ideas in real-time, which can be beneficial for investors looking to capitalize on market movements [1]

Financial Performance - Syndax Pharmaceuticals reported a quarterly loss of $0.83 per share, which is better than the Zacks Consensus Estimate of a loss of $1, representing an earnings surprise of +17.00% [1] - The company posted revenues of $37.96 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 30.74%, compared to revenues of $3.5 million in the same quarter last year [2] - Over the last four quarters, Syndax has surpassed consensus EPS estimates three times and topped consensus revenue estimates three times [2] Stock Performance - Syndax shares have declined approximately 24.5% since the beginning of the year, while the S&P 500 has gained 6.1% [3] - The current Zacks Rank for Syndax is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.81 on revenues of $36.49 million, and for the current fiscal year, it is -$3.64 on revenues of $136.56 million [7] - The trend of estimate revisions for Syndax was mixed ahead of the earnings release, which could change following the recent report [6] Industry Context - Syndax operates within the Medical - Biomedical and Genetics industry, which is currently ranked in the bottom 43% of over 250 Zacks industries [8] - Empirical research indicates that the top 50% of Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1 [8]

Syndax Pharmaceuticals (SNDX) Q2 2025 Earnings Call August 04, 2025 04:30 PM ET Company ParticipantsSharon Klahre - VP - IR & Corporate CommunicationsMichael Metzger - CEO & DirectorSteve Closter - Chief Commercial OfficerNick Botwood - Head of R&D and Chief Medical OfficerKeith Goldan - CFOAnupam Rama - Executive Director - Biotechnology Equity ResearchKevin Strang - Equity Research - BiotechnologyYigal Nochomovitz - DirectorJustin Zelin - Director - BiotechnologyDavid Dai - DirectorJason Zemansky - VP, Eq ...

Financial Data and Key Metrics Changes - In Q2 2025, Syndax Pharmaceuticals reported net product sales of nearly $100 million for Revuforge and Nyktymbo, significantly exceeding expectations [5] - Revuforge net revenue increased by 43% quarter over quarter to $28.6 million, despite one-third of patients pausing treatment for stem cell transplants [5][39] - Nyktymbo generated $36.2 million in net revenue in its first full quarter, up from $13.6 million in the first two months of launch [13][39] Business Line Data and Key Metrics Changes - Revuforge has treated over 500 patients, with approximately 90% of usage in KMT2A patients, and has penetrated 25% of the annual 2,000 patient incidents [8][18] - Nyktymbo is already profitable for Syndax, contributing $9.4 million in collaboration revenue in Q2 2025 [14][40] - The average treatment duration for Revuforge is expected to increase to 6-12 months as treatment patterns mature [21][66] Market Data and Key Metrics Changes - The market opportunity for Revuforge is projected to exceed $5 billion across relapsed refractory and frontline settings [24] - The addressable market for Revuforge in the U.S. is expected to increase to $2 billion with the anticipated approval of the supplemental new drug application (sNDA) for relapsed-refractory mutant NPM1 AML [12] - Nyktymbo targets a $2 billion total addressable market in chronic GVHD, with a current indication for 6,500 patients requiring three or more lines of therapy [26] Company Strategy and Development Direction - Syndax aims to expand Revuforge into earlier lines of therapy and additional patient populations, enhancing its market position [6][12] - The company is focused on maintaining a stable operating expense base while fully funding strategic priorities [39][42] - Syndax is advancing its leadership in menin inhibition and exploring additional indications for Nyktymbo, including idiopathic pulmonary fibrosis [37][48] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reaching profitability with current resources, citing strong performance from both product launches [43][45] - The company anticipates continued growth driven by strong physician enthusiasm and robust adoption of Revuforge and Nyktymbo [45][48] - Management highlighted the importance of clinical data and physician feedback in driving future growth and market penetration [29][31] Other Important Information - Syndax has a strong financial position with $518 million in cash and equivalents as of June 30, 2025 [43] - The company has strengthened its leadership team with the addition of Dr. Nick Botwood as Head of R&D and Chief Medical Officer [15] Q&A Session Summary Question: Path to profitability and assumptions for REVIVORGE and Nyktymbo - Management indicated that profitability is expected with existing resources, and both product launches are outperforming expectations [51][52] Question: Patients proceeding to transplant and maintenance therapy - Management noted that patients typically proceed to transplant after 2-3 cycles of treatment, and they expect a high percentage of patients to return for maintenance therapy [55][60] Question: Treatment duration observations in real-world practice - Management confirmed that the average treatment duration is expected to be 4-6 months in the first year, potentially increasing to 6-12 months as treatment patterns mature [62][66] Question: KMT-2A patient penetration and revenue growth - Management stated that they expect to reach 50% penetration of the identified KMT-2A population by the end of the year, with significant growth potential remaining [76][80] Question: FDA approval confidence and remaining open items - Management expressed confidence in the FDA approval process, indicating good progress and consistent dialogue with the agency [92][96]