Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX) Q2 2025 Earnings | 08/05/2025

16 days ago

1:47:02

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Summary of Syndax Pharmaceuticals Q2 2025 Earnings Call

Key Highlights:

Strong Financial Performance: Syndax reported robust Q2 2025 results, with Revumenib (RevuForge) net revenue up 43% QoQ to $28.6M and Nictinvo (axatilimab) generating $36.2M in net sales (with Syndax receiving $9.4M as its 50% share).
RevuForge Growth Drivers:
- Over 500 patients treated in relapsed/refractory KMT2A acute leukemia (25% of annual U.S. incidence).
- 70% of usage in second/third-line settings, with ~33% proceeding to stem cell transplant (higher than clinical trials).
- Physicians plan to restart RevuForge post-transplant for 1-2 years, extending duration of therapy.
- Priority review granted for NPM1 AML expansion (PDUFA Oct 25, 2025), potentially doubling the addressable market to 6,000 patients ($2B opportunity).
- Frontline trials underway (unfit and fit patients), targeting a $5B+ market opportunity.
Nictinvo Success:
- $50M in net revenue in first five months post-launch (chronic GVHD).
- 80-90% of patients remain on therapy, with 80% of U.S. transplant centers adopting the drug.
- Phase 2 IPF trial enrollment on track for completion in Q4 2025.
Path to Profitability:
- $518M cash on hand; expects profitability with current funds.
- Operating expenses to remain stable while funding key clinical programs.

Clinical & Regulatory Updates:

RevuForge:
- ASCO/EHA data reinforced best-in-class efficacy in KMT2A, NPM1, and NUP98R AML.
- Frontline trials (EVOLVE-2, REVEAL) progressing, with phase 1 combo data expected in Q4 2025.
Nictinvo:
- Phase 3 frontline GVHD trials (with steroids) and Phase 2 combo trials (with ruxolitinib) ongoing.

Leadership & Outlook:

Confident in sustained growth for both drugs, with RevuForge poised to dominate AML and Nictinvo expanding in GVHD/IPF.
No near-term competition in menin inhibitor space; patent protection until late 2030s.

Q&A Highlights:

Profitability: Expected via relapsed/refractory indications alone (no frontline reliance).
Duration of Therapy: Current 4-6 months (pre-transplant), projected to extend to 6-12+ months with maintenance.
NPM1 Launch: Prepared for immediate uptake upon approval (same prescriber base as KMT2A).
Real-World Evidence: Initial data expected late 2025, including post-transplant outcomes.

Conclusion: Syndax is well-positioned for long-term growth, with two commercial-stage therapies, strong execution, and a clear path to profitability.

Next Key Catalysts:

RevuForge NPM1 approval (Oct 2025).
Frontline AML trial updates (Q4 2025).
Nictinvo IPF Phase 2 data (2H 2026).

About this video

Syndax Pharmaceuticals, Inc. delivered robust Q2 2025 results, highlighting continued commercial momentum driven by strong uptake of its two new oncology therapies, Revuforj and Niktimvo. Reported GAAP revenue reached $38.0 million—far surpassing analyst expectations of $26.8 million—driven by a 43% sequential jump in Revuforj net sales and early profitability from collaboration revenue on Niktimvo, whose U.S. net revenues rose sharply to $36.2 million (with Syndax’s share at $9.4 million) in its first full quarter on the market. Despite this growth, the company posted an operating loss of $71.8 million (or $0.83 per share), a marginal increase from $68.1 million ($0.80 per share) in Q2 2024. Operating expenses rose to $107.3 million, reflecting higher investments in commercial expansion and R&D. Syndax exited the quarter with $517.9 million in cash and investments, affirming management’s guidance that this is sufficient to fund operations through to expected profitability. Key product and regulatory milestones included FDA Priority Review for Revuforj's application in relapsed/refractory mutant NPM1 acute myeloid leukemia, with a target action date of October 25, 2025, and accelerated momentum for Niktimvo in chronic graft-versus-host disease. Both products continued to gain inclusion in treatment guidelines and saw increased payer coverage, supporting the company’s commercial trajectory. Looking forward, Syndax reaffirmed its expectation that full-year 2025 operating expenses will land between $370 million and $390 million, reflecting stable future investment levels as sales ramp. The company and analysts remain optimistic, with management targeting 50% KMT2A patient penetration by year-end and continued pipeline expansion. The stock carries a consensus buy rating and price targets well above recent trading levels. About Inside Ticker: For more expert analysis and real-time updates on Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX) and other market movers, follow Inside Ticker and visit InsideTicker.com for in-depth reports, financial insights, and the latest news on leading companies. #Syndax #SNDX #Q22025 #Earnings #FinancialResults #NetLoss #Revenue #Oncology #Revuforj #Niktimvo #Growth #FDA #ClinicalTrials #MeninInhibitor #GVHD #Biotech #Pharma #Innovation #DrugLaunch #CashRunway #InsideTicker #2025Outlook #Commercialization #Cancer #AML #R&D #NASDAQ #InvestorUpdate

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