Syndax Pharmaceuticals, Inc. · NASDAQ:SNDX
Syndax Pharmaceuticals — Corporate Update (August 2024)
21 slides from Syndax Pharmaceuticals's corporate update, Aug 14, 2024
Slide 1: Niktimvo (axatilimab-csfr) FDA Approval Conference Call
Niktimvo (axatilimab-csfr) FDA Approval Conference Call August 14, 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 1 2 3 Introduction Niktimvo Label & Data Commercial Launch Plans Michael Metzger Neil Gallagher, MD, PhD Steve Closter Chief Executive Officer President, Head of R&D Chief Commercial Officer 4 5 Financial Considerations Q&A Session Keith Goldan Syndax management team Chief Financial Officer 3
Slide 4: Niktimvo (axatilimab-csfr) is now FDA approved!
Niktimvo (axatilimab-csfr) is now FDA approved! First and only treatment for chronic graft-versus-host disease (cGVHD) that binds to CSF-1R to block the processes involved in inflammation and fibrosis Approval marks a major breakthrough for patients with refractory cGVHD Robust axatilimab clinical d
Slide 5: Syndax and Incyte to co-commercialize Niktimvo in the U.S. and pursue label expansion
Syndax and Incyte to co-commercialize Niktimvo in the U.S. and pursue opportunities for label expansion CLINICAL DEVELOPMENT PROGRAMS Trial underway: • Ph 2 in idiopathic pulmonary Within 70% sales effort 30% sales effort fibrosis (IPF) U.S. 50% profit 50% profit Trials expected to initiate in 2H24:
Slide 6: There is a significant need for a new therapeutic approach to cGVHD
There is a significant need for a new therapeutic approach to cGVHD, a debilitating and difficult to treat disease cGVHD impacts multiple organ systems, drives Niktimvo is the first approved anti-CSF-1R antibody significant morbidity and impairs quality of life targeting the drivers of inflammation
Slide 7: Overview of Niktimvo (axatilimab-csfr)
INDICATION • Niktimvo is indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic Overview of therapy in adult and pediatric patients weighing at least 40 kg Niktimvo (axatilimab-csfr) U.S. prescribing info DOSAGE & ADMINISTRATION
Slide 8: Niktimvo FDA approval was based on AGAVE-201 trial data
Niktimvo FDA approval was based on AGAVE-201 trial data A randomized, open-label, multicenter study (121 study sites,16 countries) Primary endpoint: Key eligibility criteria: • Overall response rate (ORR) by Cycle 7 (28-day cycles) ▪ Adult and pediatric Day 1, including complete response or partial
Slide 9: AGAVE-201 enrolled advanced, heavily pre-treated cGVHD patients
AGAVE-201 enrolled advanced, heavily pre-treated cGVHD patients Demographics & Baseline Characteristics Niktimvo 0.3 mg/kg of Patients with cGVHD every 2 weeks (N=79) Median age, years (range) 50 (7, 76) Compared to the registrational Male, n (%) 46 (58%) population in the belumosudil trial1, AGAVE-
Slide 10: Summary from Niktimvo U.S. prescribing information
Summary from Niktimvo U.S. prescribing information Efficacy results Niktimvo 0.3 mg/kg 60% of responders every 2 weeks (N=79) maintained a response for at least 12 months1 (95% CI: 43, 74) Overall response rate through 6 months, n (%) 59 (75%) 95% CI 64, 84 56% of patients Median time to first respo
Slide 11: Safety summary from Niktimvo U.S. prescribing information
Safety summary from Niktimvo U.S. prescribing information Boxed warning: Niktimvo 0.3 mg/kg every 2 weeks (N=79) None % of patients Contraindications: None Serious adverse reactions 44% Warnings & precautions: Dose interruptions due to 44% Infusion-related reactions and embryo-fetal toxicity adverse
Slide 12: Niktimvo showed robust responses across all organs studied in AGAVE-201
Niktimvo showed robust responses across all organs studied in the heavily pre-treated population enrolled in AGAVE-201 Niktimvo 0.3 mg/kg every two weeks 100 89 Complete response 82 Partial response 80 78 76 13 Response rate, % 60 52 56 10 47 89 40 40 82 65 31 30 20 27 20 42 20 17 20 16 20 10 9 0 Lo
Slide 13: Niktimvo showed robust responses across all patient subgroups in the AGAVE-201 trial
Niktimvo showed robust responses across all patient subgroups in the AGAVE-201 trial Niktimvo 0.3 mg/kg every two weeks Primary endpoint High response rates (≥75%) were seen in patients regardless of whether they had received prior FDA- approved therapies, including belumosudil (REZUROCK), highlight
Slide 14: Niktimvo has a significant opportunity in 3L cGVHD in the U.S.
Niktimvo has a significant opportunity in 3L cGVHD in the U.S., with opportunities for geographical and label expansion 2024 Beyond Of the 17,000 U.S. chronic GVHD patients on treatment at any one time, we will target the ~6,500 progressing to later lines of treatment after at least two previous lin
Slide 15: Strategic imperatives for U.S. Niktimvo launch
Strategic imperatives for U.S. Niktimvo launch 1. Position Niktimvo as a differentiated 3L cGVHD treatment 2. Secure broad payor coverage for Niktimvo 3. Ensure access and adherence to Niktimvo 15
Slide 16: Targeted Niktimvo launch strategy will be led by highly experienced team
Targeted Niktimvo launch strategy will be led by highly experienced team from Incyte and Syndax • Incyte to lead commercialization and contribute 70% of sales effort, leveraging their leadership in GVHD and extensive pre-existing relationships • Syndax to contribute 30% of sales effort, deploying it
Slide 17: Syndax and Incyte are committed to driving access to Niktimvo
Syndax and Incyte are committed to driving access to Niktimvo for PATIENT SUPPORT appropriate patients Eligible U.S. patients prescribed Niktimvo will have access to IncyteCARES, a comprehensive patient support program, at the time of product launch PAYOR ENGAGEMENT Prior to approval, Incyte led rob
Slide 18: Accounting for net profits/losses on sales of Niktimvo: Illustrative example
Accounting for net profits/losses on sales of Niktimvo: Illustrative example Syndax will report collaboration profits on a net basis; Incyte will record product sales Net Profits: Niktimvo Assumption Syndax Illustrative P&L Net product sales of Niktimvo $ 1,000 Collaborative Arrangement Revenue $ 32
Slide 19: Expected upcoming milestones
Niktimvo (axatilimab-csfr) Anti-CSF-1R • Launch in refractory chronic GVHD no later than early first quarter 2025 • Initiation of chronic GVHD frontline combination trial with Jakafi in 2H24 • Initiation of chronic GVHD frontline combination trial with steroids in 2H24 Expected REVUMENIB Menin-KMT2A
Slide 20: Determined to realize a future in which people with cancer live longer and better
Determined to realize a future in which people with cancer live longer and better than ever before. 20
Slide 21: TON
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