Syndax Pharmaceuticals, Inc. · NASDAQ:SNDX
Syndax Pharmaceuticals — 43rd Annual J.P. Morgan Healthcare Conference (January 2025)
24 slides from Syndax Pharmaceuticals's conference presentation, Jan 14, 2025
Slide 1: Syndax Corporate Presentation
Syndax Corporate Presentation 43rd Annual J.P. Morgan Healthcare Conference January 14, 2025
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 a commercial-stage oncology company with two first-in-class medicines
Syndax is a commercial-stage oncology company with two first-in-class medicines with practice-changing and billion-dollar potential Syndax delivered on multiple major milestones in 2024, including two FDA approvals within ~90 days of each other Launched first and only menin inhibitor for R/R Receive
Slide 4: Menin inhibition: a promising new modality for certain genetically-defined acute leukemias
MENIN INHIBITION A PROMISING NEW MODALITY FOR CERTAIN GENETICALLY- DEFINED ACUTE LEUKEMIAS 4
Slide 5: Syndax is positioned to lead in menin inhibition, a multi-billion-dollar opportunity
Syndax is positioned to lead in menin inhibition, an exciting new class with multi-billion-dollar opportunity OPPORTUNITY UNIQUE POSITIONING First and only approved menin inhibitor Up to 50% of AML patients1-2 Differentiated product profile supported have genetic alterations which may be susceptible
Slide 6: Syndax is aggressively executing on its menin strategy
Syndax is aggressively executing on its menin strategy designed to drive long-term growth 3 2 ADVANCE INTO FRONTLINE 1 EXPAND APPROVAL INTO R/R mNPM1 AML SECURE FIRST MOVER ADVANTAGE 2024-2025 2025 Future 6
Slide 7: Revuforj (revumenib) is the first and only FDA-approved menin inhibitor
Revuforj® (revumenib) is the first and only FDA-approved menin inhibitor Approved for an aggressive form of R/R acute leukemia with an urgent unmet need Broad indication, including adults and peds First mover advantage Revuforj is indicated for the treatment of relapsed or refractory positions Synda
Slide 8: Key pre-launch activities have set the foundation for a successful U.S. Revuforj launch
Key pre-launch activities have set the foundation for a successful U.S. Revuforj launch Prior to launch, Syndax reached ~2,000 accounts where >98% of KMT2Ar Hired highly-experienced commercial team patients receive treatment with average of 22 yrs of experience, primarily in hem/onc Profiled account
Slide 9: U.S. launch of Revuforj is underway with encouraging early progress
U.S. launch of Revuforj is underway with encouraging early progress Drug in channel 5 days after approval with immediate ordering Scripts received from institutions Reimbursement seen from all across the U.S. (major academic Early payer types centers & community practices) Milestones Added to NCCN G
Slide 10: Syndax is aggressively executing on its menin strategy
Syndax is aggressively executing on its menin strategy designed to drive long-term growth 3 2 ADVANCE INTO FRONTLINE 1 EXPAND APPROVAL INTO R/R mNPM1 AML SECURE FIRST MOVER ADVANTAGE 2024-2025 2025 Future 10
Slide 11: Well positioned to receive an indication in R/R mNPM1 AML
Syndax is well positioned to receive an indication in R/R mNPM1 AML, further securing our competitive advantage Completed milestones Reported consistent results in a larger Anticipated milestones population (N=77) ORR = 48%; CR/CRh = 26% Submit sNDA to FDA Dec 2024 1H 2025 Nov 2024 1H 2025 ~YE 2025
Slide 12: Syndax is aggressively executing on its menin strategy
Syndax is aggressively executing on its menin strategy designed to drive long-term growth 3 2 ADVANCE INTO FRONTLINE 1 EXPAND APPROVAL INTO R/R mNPM1 AML SECURE FIRST MOVER ADVANTAGE 2024-2025 2025 Future 12
Slide 13: Rapidly advancing our frontline strategy in KMT2Ar acute leukemia and mNPM1 AML
Rapidly advancing our frontline strategy in KMT2Ar acute leukemia and mNPM1 AML Revumenib clinical development programs (KMT2Ar or mNPM1 acute leukemias) across the treatment paradigm RELAPSED / FRONTLINE MAINTENANCE REFRACTORY “UNFIT” “FIT” HOVON Trial AUGMENT-101 Ph 2/3 Rev + I.C. Rev maintenance
Slide 14: SAVE and BEAT AML data highlight revumenib's promising combination potential
SAVE and BEAT AML data highlight revumenib’s promising combination potential SAVE BEAT AML (MD Anderson Cancer Center) (LLS' Beat AML® Master Clinical Trial) Relapsed or refractory Newly diagnosed Population pediatric and adult AML or MPAL patients with patients ≥60 years of age with mNPM1, KMT2Ar,
Slide 15: Pivotal trial of revumenib + ven/aza in frontline unfit population
In the frontline unfit population, Syndax will initiate a pivotal trial of revumenib + ven/aza In the frontline fit population, A randomized, double-blind, placebo-controlled, clinical trial in collaboration with the HOVON network an ongoing Ph 1 trial with I.C. is designed to identify the RP2D and
Slide 16: Commercial opportunity in menin inhibition estimated to exceed $4B in the U.S.
Syndax is well-positioned to lead in menin inhibition, a commercial opportunity estimated to exceed $4B in the U.S. alone ~ $2B market > $4B market Market Opportunity ($ B) ~ $1B market ~ $.75 - $1.25B market ~ $.75B market R/R R/R 1L “Unfit” 1L “Fit” Total Acute Leukemia Acute Myeloid Acute Leukemi
Slide 17: CSF-1R inhibition: a novel mechanism for targeting inflammation and fibrosis in cGVHD
CSF-1R INHIBITION A NOVEL MECHANISM FOR TARGETING INFLAMMATION AND FIBROSIS IN cGVHD WITH POTENTIAL FOR EXPANSION 17
Slide 18: Executing on strategy to drive long-term growth with Niktimvo
Syndax is aggressively executing on its strategy designed to drive long-term growth with Niktimvo FDA approved for treatment of chronic GVHD after failure of at least 3 two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg Included in NCCN Guidelines® Prep
Slide 19: $350M Royalty Pharma deal highlights Niktimvo's multi-billion-dollar potential
$350M Royalty Pharma deal highlights Niktimvo’s multi-billion-dollar potential Upfront $350M payment in exchange for a 13.8% capped royalty on U.S. net sales allows Syndax to maintain revenue and retain upside VALUATION REFLECTS MULTIPLE FACTORS Significant cGVHD Population Differentiated Product Pr
Slide 20: Looking Ahead
LOOKING AHEAD 20
Slide 21: Expected upcoming milestones
Revuforj (revumenib) Menin-KMT2A inhibition • Maximize U.S. adoption of Revuforj as the preferred menin inhibitor • Submit sNDA in R/R mNPM1 AML in 1H25, with potential approval around YE 2025 • Publish pivotal R/R mNPM1 AML data in 1H25 • Initiate a pivotal frontline trial of revumenib with ven/aza
Slide 22: Syndax is positioned for long-term growth with two first-in-class therapies
Syndax is positioned for long-term growth with two first-in-class therapies with multi-billion-dollar potential Significant lead in menin, an exciting new Revuforj positioned for a unique launch class supported by a growing mountain trajectory with near-term potential for a of clinical evidence seco
Slide 23: 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. 23
Slide 24: TON
vy TON
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