Syndax Pharmaceuticals, Inc. · NASDAQ:SNDX
Syndax Pharmaceuticals — Q3 2024 Earnings Presentation
14 slides from Syndax Pharmaceuticals's earnings presentation, Nov 5, 2024
Slide 1: Third Quarter Financial Results Presentation
Third Quarter Financial Results Presentation / November 5, 2024
Slide 2: Forward-looking statements disclosure
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 referenci
Slide 3: Syndax is delivering on transformative milestones
Syndax is delivering on transformative milestones Received FDA approval for Niktimvo (axatilimab-csfr) in chronic graft-versus-host disease (GVHD), in partnership with Incyte Completed $350 million royalty funding agreement for Niktimvo Published pivotal Niktimvo data in the NEJM and announced the i
Slide 4: AUGMENT-101: New data from R/R KMT2Ar acute leukemia cohort
AUGMENT-101: New data from R/R KMT2Ar acute leukemia cohort highlight revumenib’s compelling clinical profile ASH 2024 abstract #211 Compared to previously reported interim analysis presented at ASH 2023, this updated Robust responses in analysis increases the size of the Phase 2 safety and efficacy
Slide 5: AUGMENT-101: Longer follow-up highlights revumenib's durability
AUGMENT-101: Longer follow-up from KMT2Ar interim analysis population highlights revumenib’s durability ASH 2024 abstract #211 Efficacy Evaluable Population at Ph 2 Interim Analysis (n=57) Overall response rate (ORR) 36 (63%) Continued treatment CR/CRh 13 (23%) and follow-up show durable responses i
Slide 6: SAVE: Revumenib-ven/HMA combo in R/R AML
SAVE: Revumenib-ven/HMA combo Responses (n=26) in R/R AML resulted in high rates of ORR 23 (88%) remission, MRD negativity & HSCT CR 12 (46%) ASH 2024 abstract #216 CRh 3 (12%) Patient Characteristics (n=26) CRp 3 (12%) Years of age, median (range) 35 (12-79) PR 1 (4%) KMT2Ar/mNPM1/NUP98r enrolled,
Slide 7: Revumenib could provide significant benefit across the treatment paradigm
Revumenib could provide significant benefit in KMT2Ar and mNPM1 acute leukemias across the treatment paradigm KMT2Ar & mNPM1 Relapsed / acute leukemia Frontline Maintenance Refractory treatment paradigm Revumenib clinical development program (KMT2Ar and mNPM1 acute leukemia) - ongoing trials ASH 202
Slide 8: Pivotal frontline trial of revumenib + ven/aza on track to initiate by YE24
Pivotal frontline trial of revumenib + ven/aza on track to initiate by YE24 Frontline triplet will be studied in a randomized, double-blind, placebo-controlled, clinical trial in collaboration with the HOVON network Newly diagnosed Revumenib + Primary endpoint: adults with mNPM1 venetoclax + azaciti
Slide 9: Pivotal revumenib topline readout in R/R mNPM1 AML on track for 4Q24
Pivotal revumenib topline readout in R/R mNPM1 AML on track for 4Q24 mNPM1 AML Disease Background NPM1 mutations are the most common genetic alterations in AML ~30% of AML patients have NPM1 mutations On average, mNPM1 patients are older, and less fit for HSCT than KMT2Ar R/R mNPM1 AML patients have
Slide 10: Niktimvo (axatilimab-csfr) is now FDA approved in the U.S.
Niktimvo (axatilimab-csfr) is now FDA approved in the U.S. Niktimvo clinical FDA approved for treatment of chronic GVHD after development programs failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg Underway: Included in NCCN Guidelines® •
Slide 11: Syndax is uniquely positioned to establish a successful menin franchise
Syndax is uniquely positioned to establish a successful menin franchise Opportunity to secure significant Launch-ready organization first-to-market advantages, comprised of professionals with starting with R/R KMT2Ar extensive heme-onc experience Poised for unique launch Revumenib is trajectory, as
Slide 12: Financial highlights and financial guidance
Financial highlights and financial guidance Ticker SNDX (NASDAQ) Cash and equivalents (30 September 2024) $399.6 M Shares outstanding* (30 September 2024) 85.6 M 2024 Operating Expense Guidance FY24 Research and development $245 – $250 M Total operating expenses^ $365 – $370 M Syndax expects that it
Slide 13: Expected upcoming milestones
REVUMENIB Menin-KMT2A disruption • Presentation of acute leukemia data at ASH 2024 • Pivotal data from AUGMENT-101 R/R mNPM1 AML cohort in 4Q24; potential sNDA filing in 1H25 • PDUFA action date of December 26, 2024, in R/R KMT2Ar acute leukemia, followed by immediate launch • Initiation of pivotal
Slide 14: TON
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Syndax Pharmaceuticals — Q3 2024 Earnings Presentation on 6ix