Syndax Pharmaceuticals, Inc. · NASDAQ:SNDX
Syndax Pharmaceuticals — Corporate Update (November 2024)
24 slides from Syndax Pharmaceuticals's corporate update, Nov 15, 2024
Slide 1: Revuforj (revumenib) FDA Approval Conference Call
Revuforj® (revumenib) FDA Approval Conference Call November 15, 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: Agenda
Agenda Introduction 1 Michael Metzger, CEO Revuforj U.S. Prescribing Information 2 Neil Gallagher, MD, PhD, President, Head of R&D JCO Publication & Development Program 3 Neil Gallagher, MD, PhD, President, Head of R&D Revuforj U.S. Launch Plans 4 Steve Closter, CCO Financial Considerations 5 Keith
Slide 4: Revuforj (revumenib) is now FDA approved!
Revuforj® (revumenib) is now FDA approved! First and only FDA-approved menin inhibitor Only targeted therapy for KMT2A translocations Approved for treatment of relapsed or refractory (R/R) acute leukemia with a KMT2A translocation in patients 1 year and older Robust Revuforj clinical development str
Slide 5: Urgent need to improve treatment for R/R acute leukemia patients with a KMT2A translocation
There is an urgent need to improve treatment for R/R acute leukemia patients with a KMT2A translocation Disease Background Rearrangements of the KMT2A gene (KMT2Ar), cause ~10% of acute leukemias1 >95% of KMT2Ar acute leukemia patients have a KMT2A translocation, a type of rearrangement that occurs
Slide 6: Overview of Revuforj (revumenib) U.S. Prescribing Information
Overview of Revuforj (revumenib) U.S. Prescribing Information
Slide 7: Overview of Revuforj U.S. Prescribing Information
Overview of Revuforj U.S. Prescribing Information Indication: • Revuforj is a menin inhibitor indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older Dosage Forms & Strengths
Slide 8: The AUGMENT-101 pivotal trial formed the basis for the approval of Revuforj
The AUGMENT-101 pivotal trial formed the basis for the approval of Revuforj Phase 1 Phase 2 Dose Escalation Pivotal Trials KMT2Ar FDA approved Ph 1 and Ph 2 data from the ALL/MPAL AUGMENT-101 trial were used to RP2D support the FDA approval for AML R/R acute leukemia with a Adults and pediatrics KMT
Slide 9: Baseline demographics/characteristics from Revuforj Prescribing Information
Baseline demographics/characteristics from Revuforj Prescribing Information Across the Phase 1/2 AUGMENT-101 trial, Revuforj was studied in R/R acute leukemia patients with a KMT2A translocation Demographic and Disease Characteristics Revuforj (N = 104) Revuforj was studied in: Age, median, years (r
Slide 10: Efficacy summary from Revuforj Prescribing Information
Efficacy summary from Revuforj Prescribing Information Efficacy results from the Phase 1/2 AUGMENT-101 trial formed the basis for the approval of Revuforj Revuforj Endpoint N = 104 CR+CRh, n (%) 22 (21.2) 1.9 months 95% CI (13.8, 30.3) median time to CR or CRh Median duration of CR+CRh (months) 6.4
Slide 11: Safety overview from Revuforj Prescribing Information
Safety overview from Revuforj Prescribing Information The label includes safety data from 135 R/R acute leukemia patients (104 adult and 31 pediatric) with a KMT2A translocation who were treated with Revuforj Boxed warning: Revuforj (N=135) • Differentiation syndrome (DS) Adverse reactions leading 4
Slide 12: Overview of JCO Publication & Clinical Development Program
Overview of Journal of Clinical Oncology (JCO) Publication & Clinical Development Program
Slide 13: JCO publication highlights rates of ORR, MRD negativity and HSCT
JCO publication highlights rates of ORR, MRD negativity and HSCT in R/R acute leukemia patients with a KMT2A translocation who received Revuforj Publication includes data from the 57 efficacy evaluable patients in the pre-specified Phase 2 AUGMENT-101 trial interim analysis Ph 2 Interim Analysis Eff
Slide 14: Multiple ongoing and planned revumenib trials support potential label expansion
Multiple ongoing and planned revumenib clinical trials support potential label expansion and franchise opportunity KMT2Ar & mNPM1 Relapsed / acute leukemia Frontline Maintenance Refractory treatment paradigm Revumenib clinical development program (acute leukemia with a KMT2Ar or NPM1 mutation) - ong
Slide 15: Revuforj (revumenib) U.S. Launch Plans
Revuforj (revumenib) U.S. Launch Plans
Slide 16: Syndax is uniquely positioned to establish a successful menin franchise
Syndax is uniquely positioned to establish a successful menin franchise First and only FDA-approved menin Urgent unmet need in R/R inhibitor enables significant KMT2Ar acute leukemia expected first-to-market advantages to drive rapid uptake Opportunity for a unique Revuforj is launch trajectory, wit
Slide 17: Market Opportunity ($ B)
Initial Revuforj indication in R/R acute leukemia with a KMT2A translocation represents a significant market opportunity with potential for label expansion On-label target Opportunities for future potential label expansion ~ $2B market > $4B market Market Opportunity ($ B) ~ $1B market ~ $.75 - $1.2
Slide 18: Three strategic imperatives to drive a successful launch
We will focus on three strategic imperatives to drive a successful launch and secure first-to-market advantages 1 2 3 Strategic imperatives Leave no patient behind Engage all key stakeholders Deliver premium experience High-risk patients require Complex patient journey Critically ill patients Key in
Slide 19: Highly-experienced customer facing teams built to drive patient and customer experience
Highly-experienced customer facing teams are built to drive best-in-class patient and customer experience ~50 highly experienced Hem-Onc Oncology Account Managers professionals will support Revuforj launch Other Pathologist Systems of Care Directors Specialists • 22 years of average Syndax experienc
Slide 20: Field teams will target ~2,000 accounts where 98%+ of KMT2Ar patients receive treatment
Field teams will target ~2,000 accounts where 98%+ of KMT2Ar patients receive treatment Key pre-launch activities have been completed, setting strong foundation for launch ~200 accounts are estimated to represent 2/3 of the opportunity Drive Syndax and disease state/mechanism of disease awareness wi
Slide 21: Robust payor engagement prior to launch to expedite formulary review
Robust payor engagement prior to launch is anticipated to expedite formulary review and coverage decisions Key pre-approval activities completed: Educated payors on burden of Conducted payor research Reached plans covering disease and provided scientific to inform our strategy and >90% of all covere
Slide 22: Robust U.S. patient support program is in place for Revuforj launch
Robust U.S. patient support program is in place for Revuforj launch Patient Support Program How the SyndAccess Patient Support Team Can Help* ACCESS AFFORDABILITY ADHERENCE Support with understanding A Patient Assistance Program and Oncology-certified nurses may insurance coverage, benefit copay sup
Slide 23: Expected upcoming milestones
Revuforj (revumenib) Menin-KMT2A inhibition • U.S. launch of Revuforj in November • Presentation of acute leukemia data at ASH 2024 • Initiation of pivotal combination trial with ven/aza in newly diagnosed mNPM1 or KMT2Ar acute leukemias by YE24 • Publish and present pivotal R/R mNPM1 AML data at a
Slide 24: CON
ry, CON
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