Syndax Pharmaceuticals, Inc. · NASDAQ:SNDX
Syndax Pharmaceuticals — Investor Presentation (October 2023)
17 slides from Syndax Pharmaceuticals's investor presentation, Oct 2, 2023
Slide 1: Revumenib AUGMENT-101 Data in R/R KMT2Ar Acute Leukemia
Revumenib AUGMENT-101 Data in R/R KMT2Ar Acute Leukemia October 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," "estimate," "intend," “could,” "believe" and similar expressions (as we
Slide 3: Revumenib positioned as a first- and best-in-class therapy
Revumenib positioned as a first- and xxx best-in-class therapy Response IDMC recommends 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 s
Slide 4: Despite recent advances in AML and ALL, treatment options are needed for KMT2Ar and mNPM1 acute leukemias
Despite recent advances in AML and ALL, treatment options are needed for patients with KMT2Ar and mNPM1 acute leukemias KMT2Ar Acute Leukemia NPM1 Mutant AML 10% of AML or ALL1 30% of AML2 • NCCN guidelines denote KMT2Ar • Most frequent genetic alteration in AML predicts poor prognosis • Response ra
Slide 5: Revumenib's unique MOA turns off leukemic transcriptional programs
Revumenib’s unique MOA turns off leukemic transcriptional programs by binding to menin and displacing KMT2A (MLL) complexes KMT2Ar or mNPM1 acute leukemias Menin inhibition with revumenib revumenib Menin KMT2A* KMT2A* Menin HOX OFF Menin HOX KMT2A* Leukemia MEIS OFF Differentiation MEIS / Apoptosis
Slide 6: AUGMENT-101 trial assessing revumenib monotherapy in R/R acute leukemia
AUGMENT-101 trial assessing revumenib monotherapy in R/R acute leukemia: NDA submission for R/R KMT2Ar expected by year-end Pivotal Trials KMT2Ar AUGMENT-101 designed to rule out a KMT2Ar ALL null-hypothesis of 10% Adult and CR/CRh response in KMT2Ar AML pediatric patients pooled R/R KMT2Ar with R/R
Slide 7: Innovative AUGMENT-101 design accelerates time to NDA for KMT2Ar acute leukemia
Innovative AUGMENT-101 design accelerates time to NDA for KMT2Ar acute leukemia 2H22 1H23 2H23 KMT2Ar* AML + ALL 57th patient enrolled in IDMC reviewed KMT2Ar data; 1Q23 and followed recommended stopping KMT2A Protocol updated to define KMT2Ar for 6 months cohorts for efficacy AML + ALL as one poole
Slide 8: The AUGMENT-101 trial enrolled heavily pretreated R/R KMT2Ar patients
The AUGMENT-101 trial enrolled heavily pretreated R/R KMT2Ar patients Majority of the patients enrolled in AUGMENT-101 pivotal trial relapsed after salvage therapy Efficacy Evaluable Safety Population Baseline Characteristics n = 57 n = 94 Median age, years (range) 34 (1.3,75) 37 (1.3, 75) Adult, n
Slide 9: AUGMENT-101 pivotal data: Establishes compelling efficacy in KMT2Ar acute leukemia
AUGMENT-101 pivotal data: Establishes compelling efficacy in KMT2Ar acute leukemia Pooled Efficacy AML Efficacy Best Response n = 57 (%) n = 49 (%) Overall Response Rate1 36 (63%) 32 (65%) CR/CRh 13 (23%) 12 (24.5%) (95% Conf. interval); p-value2 (12.7, 35.8); 0.0036 • ~ 2/3 of patients CR 10 (18%)
Slide 10: Potential to change the treatment paradigm: post-transplant maintenance in late-stage KMT2Ar
Potential to change the treatment paradigm: post-transplant maintenance in late-stage KMT2Ar Current benchmark: < 5% R/R KMT2Ar patients taken to transplant1 Revumenib enables Responder physicians to aggressively 36/57 (63%) treat KMT2Ar: 8/14 (57%) patients taken to Received 1. Drives high levels o
Slide 11: Safety profile observed among R/R KMT2Ar acute leukemia patients in AUGMENT-101
Safety profile observed among R/R KMT2Ar acute leukemia patients enrolled in AUGMENT-101 pivotal trial consistent with previously reported data Safety Population ≥ Grade 3 treatment-related AEs Safety Population Any-grade treatment-related AEs (≥20%) n = 94 observed in ≥2 patients n = 94 Patients wi
Slide 12: Revumenib could provide significant benefit in mNPM1 and KMT2Ar acute leukemias
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 acute leukemia Relapsed / Frontline Maintenance treatment paradigm Refract
Slide 13: Revumenib's profile supports use as backbone therapy across treatment continuum
Revumenib’s profile supports use as 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 1L “Unfit”
Slide 14: Revumenib: first-in-class drug with blockbuster potential in acute leukemia
Revumenib: first-in-class drug with blockbuster potential in acute leukemia Targets highest Excellent benefit-risk profile First & best in a >$4B market mutational frequency • Target population represents 35- • Well tolerated and achieves high • Potential for first age- and 40% of AML, 10-15% of ALL
Slide 15: Expected upcoming milestones for revumenib
Present full AUGMENT-101 results at an upcoming medical meeting NDA submission in R/R KMT2Ar acute leukemia by year-end 2023 Expected upcoming Initiate a combination trial with intensive chemo (7+3) by year-end 2023 milestones for revumenib Additional data from ongoing revumenib studies in 4Q23 Enro
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 — Investor Presentation (October 2023) on 6ix