Syndax Pharmaceuticals (SNDX) Q3 2024 earnings summary

Executive summary

• Achieved FDA approval for Niktimvo (axatilimab-csfr) in chronic GVHD in August 2024, with U.S. launch expected by early Q1 2025 and co-commercialization with Incyte.

• Revumenib NDA for R/R KMT2A-r acute leukemia is under FDA Priority Review with a PDUFA date of December 26, 2024; topline pivotal data in mNPM1 AML expected Q4 2024 and potential sNDA filing in H1 2025.

• Transitioned to a commercial-stage company, supported by a $350M royalty funding agreement for Niktimvo, expected to fund operations through profitability.

• Net loss for Q3 2024 was $84.1M, driven by increased R&D and SG&A expenses; no product sales revenue yet, with revenue derived from milestones and license agreements.

• Multiple pivotal clinical data publications and major conference presentations for both Niktimvo and revumenib.

Financial highlights

• Ended Q3 2024 with $399.6M in cash, equivalents, and investments; $350M royalty funding received in November 2024, bringing pro forma cash to ~$750M.

• Q3 2024 revenue was $12.5M, primarily from a Niktimvo approval milestone; nine-month revenue totaled $16.0M.

• Q3 2024 operating expenses were $102.1M, including $71M R&D and $31.1M SG&A; full-year 2024 guidance: R&D $245–$250M, total expenses $365–$370M, with $41M non-cash stock compensation.

• Net loss per share was $(0.98) for Q3 2024; weighted-average shares outstanding: 85.4M.

• Cash used in operations was $217.5M for the nine months ended September 30, 2024.

Outlook and guidance

• Niktimvo U.S. launch anticipated by early Q1 2025; two smaller vial sizes submitted for FDA approval.

• Revumenib topline pivotal data in mNPM1 AML expected Q4 2024, with potential sNDA filing in H1 2025; PDUFA date for R/R KMT2A-r acute leukemia is December 26, 2024.

• Pivotal frontline trial of revumenib plus venetoclax/azacitidine in NPM1/KMT2A AML to initiate by year-end 2024.

• Niktimvo added to NCCN Guidelines as category 2A for cGVHD; further clinical trials in IPF and cGVHD ongoing.

• Cash runway, including royalty funding, expected to fund operations for at least 12 months and through profitability.