Syndax Pharmaceuticals, Inc. · NASDAQ:SNDX
Syndax Pharmaceuticals — Q3 2023 Earnings Presentation
17 slides from Syndax Pharmaceuticals's earnings presentation, Nov 2, 2023
Slide 1: SNDX Third Quarter 2023 Results
SNDX Third Quarter 2023 Results / November 2, 2023
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: Delivering on important milestones in 2H23
Presented AGAVE-201 topline pivotal data Presented AUGMENT-101 topline pivotal data R/R KMT2Ar acute leukemia Initiated revumenib NDA submission for R/R KMT2Ar acute leukemia under RTOR Delivering on important Announced final AUGMENT-101 Phase 1 data in R/R mNPM1 AML patients milestones in 2H23 Pres
Slide 4: Revumenib positioned as a first- and best-in-class therapy
Revumenib positioned as a first- and xxx best-in-class therapy Response IDMC recommended stopping AUGMENT-101 KMT2Ar cohorts for efficacy at protocol-defined interim analysis Durability MRD-negative • Trial met primary endpoint (p-value = 0.0036) Patient • Majority of patients achieved a clinically
Slide 5: AUGMENT-101 KMT2Ar pivotal data establishes efficacy; durable, MRD-neg responses
AUGMENT-101 KMT2Ar pivotal data establishes compelling efficacy; drives durable, MRDneg responses Data presentation at ASH 2023 (Abstract #2907) Enables deep, durable responses in late line R/R acute leukemia Overall response rate 63% in pooled analysis Enables a high rate of deep, durable MRDneg re
Slide 6: Thought leaders indicate revumenib may change the treatment paradigm for R/R KMT2Ar acute leukemia
Thought leaders indicate revumenib may change the treatment paradigm for R/R KMT2Ar acute leukemia Data presentation at ASH 2023 (Abstract #4950) Anticipated KMT2Ar treatment paradigm upon revumenib approval Revumenib Revumenib HSCT maintenance Relapsed or Refractory 63% respond 39% receive 71% rece
Slide 7: Phase 1 results suggest robust efficacy in mNPM1 AML
Phase 1 results suggest robust efficacy in mNPM1 AML Pivotal trial enrollment ongoing Phase 1 Dose Escalation • 36% CR/CRh Pts @ MRD- RP2D* CR/CRh (CR/CRh) ORR • 100% CR/CRh ASH 2022 data 11 3 (27%) 3 (100%) 5 (45%) responders MRD-neg Adults with R/R mNPM1 AML 2023 data 3 2 (67%) 2 (100%) 2 (67%) •
Slide 8: R/R mNPM1 patients achieve durable, MRD-negative responses with revumenib
R/R mNPM1 patients achieve durable, MRD- negative responses with revumenib CR/CRh Transplant CR/CRh # of prior Tx MLFS Transplant PD 2 MRD(-) CR/CRh MLFS Follow-up ongoing 2 MRD(-) CR/CRh CR/CRh MRD(-) PD Follow-up ongoing Response ongoing • 3/7 responders 2 MRD(-) CR/CRh proceeded to HSCT CR/CRh MR
Slide 9: SAVE AML supports all-oral revumenib-venetoclax-decitabine/cedazurine combo
SAVE AML supports efficacy, safety and tolerability of all-oral revumenib- venetoclax-decitabine/cedazurine combo in R/R mNPM1, KMT2Ar or NUP98r Full data presentation at ASH 2023 (Abstract #58) Summary of Enrolled Patients & Response Data Safety Summary N (%) Subtype All grade TRAEs Grade ≥3 KMT2Ar
Slide 10: Revumenib could provide significant benefit across the treatment paradigm
Revumenib could provide significant benefit in mNPM1 and KMT2Ar acute leukemias across the treatment paradigm Initial data supporting combinability with venetoclax and chemo-based regimens to be presented in 4Q mNPM1 & KMT2Ar Relapsed / acute leukemia Frontline Maintenance treatment paradigm Refract
Slide 11: Revumenib supports use as backbone therapy across treatment continuum; >$4B US market
Revumenib’s profile supports use as potential backbone therapy across treatment continuum — providing access to >$4B US market opportunity Significant growth potential with indications in earlier lines of treatment > $4B market Market Opportunity ($ B) ~ $2B market ~ $1B market ~ $1-1.5B market R/R
Slide 12: AGAVE-201 results support axatilimab's safety and efficacy profile
AGAVE-201 results support axatilimab's promising safety and efficacy profile Data presentation at ASH 2023 Plenary Session (Abstract #1) Met the primary endpoint in patients ORR by cycle 7 day 1 74% (95% CI [63, 83]) with R/R cGVHD Durable responses with a reduction in Of responders maintained 60% a
Slide 13: Axatilimab has potential to expand into additional high value indications
Axatilimab has the potential to expand into additional high value indications and new geographies Expansion into fibrotic indications: ~215,000 US IPF POC* init YE23 ~335,000 WW2 2024 & Beyond Expansion into EU, Japan, ROW >35,000 WW1 R/R chronic GVHD: ~14,000 US1 BLA submission expected YE23 2024 P
Slide 14: Financial highlights and financial guidance
Financial highlights and financial guidance Ticker SNDX (NASDAQ) Cash and equivalents (at 30 Sept 2023) $379.3 million Shares outstanding* (at 30 Sept 2023) 69.9 million 2023 Operating Expense Guidance FY23 (reduced) Research and development $160 – $165 million Total operating expenses^ $225 – $230
Slide 15: Expected upcoming clinical milestones
REVUMENIB Menin-KMT2A disruption • ASH 2023 Presentations: AUGMENT-101 pivotal data (KMT2Ar), post- transplant maintenance experience and data from SAVE trial • Additional data from revumenib combination studies at ASH/4Q23 Expected • Complete NDA submission in R/R KMT2Ar acute leukemia (RTOR) by YE
Slide 16: Syndax on cusp of significant transformation with value-creating milestones ahead
Syndax on cusp of significant transformation with value-creating milestones ahead Oncology innovator with proven ability to successfully advance novel, differentiated cancer programs Innovative pipeline with strong potential to deliver meaningful clinical benefits to address a large unmet need Poise
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Syndax Pharmaceuticals — Q3 2023 Earnings Presentation on 6ix