Syndax Pharmaceuticals, Inc. · NASDAQ:SNDX
Syndax Pharmaceuticals — Q2 2024 Earnings Presentation
15 slides from Syndax Pharmaceuticals's earnings presentation, Aug 1, 2024
Slide 1: Second Quarter Financial Results Presentation
Second Quarter Financial Results Presentation / August 1, 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: Syndax is on track for a historic year, with multiple near-term milestones
Syndax is on track for a historic year, with multiple transformative, near-term milestones 2Q CLINICAL MILESTONES UPCOMING ANTICIPATED MILESTONES Presented updated positive PDUFA action date of August 28, 2024, for axatilimab revumenib combination data in acute leukemias and axatilimab PDUFA action
Slide 4: Revumenib could provide significant benefit in KMT2Ar and mNPM1 acute leukemias
Revumenib could provide significant benefit in KMT2Ar and mNPM1 acute leukemias across the treatment paradigm KMT2Ar & mNPM1 Relapsed / acute leukemia Frontline Maintenance Refractory treatment paradigm Revumenib clinical development program (KMT2Ar and mNPM1 acute leukemia) - ongoing trials Pivotal
Slide 5: Updated BEAT AML data show revumenib's potential to enhance ven/aza combo
Updated BEAT AML data show revumenib’s potential to enhance ven/aza combo in frontline mNPM1 or KMT2Ar AML Summary of Enrolled Patients (n=26) Safety Highlights KMT2Ar: 9 Genetics, n • Overall, no new or increased safety signals observed mNPM1: 17 outside of known reported ven/aza toxicities Summary
Slide 6: Updated AUGMENT-102 revumenib data show benefit in chemo combo (FLA)
Updated AUGMENT-102 revumenib data show benefit in chemo combo (FLA) in late line R/R KMT2Ar, mNPM1 or NUP98r AML without added AEs Summary of Enrolled Patients in Total Population (N=27) Safety Highlights Median years of age (range) 6.0 (0.8–78.0) • AE profile consistent with intensive chemo in R/R
Slide 7: Upcoming pivotal mNPM1 AML data expected to build on positive Phase 1 results
Upcoming pivotal mNPM1 AML data expected to build on positive Phase 1 results suggesting robust efficacy with durable, MRDneg responses Phase 1 3/7 1 Dose Escalation (43%) of responders patient restarted proceeded to HSCT revumenib post HSCT* n (%) Total mNPM1 @ RP2D 14 CR/CRh 5 (36%) 3/5 TRAEs pati
Slide 8: Syndax is ready to launch revumenib in the U.S. upon anticipated FDA approval
Syndax is ready to launch revumenib in the U.S. upon anticipated FDA approval Medical Commercial Market Access • Executing publication plan • Mapped patient journey and key • Ongoing pre-approval information stakeholders exchange with payers • Ongoing scientific exchange with thought leaders • Ident
Slide 9: 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 U.S. market opportunity Significant growth potential with indications in earlier lines of treatment ~ $2B market > $4B market Market Opportunity ($ B) ~ $1B market ~ $.75 - $1.25B market ~ $.75
Slide 10: Syndax and Incyte are preparing for U.S. approval and launch of axatilimab
Syndax and Incyte are preparing for anticipated U.S. approval and launch of axatilimab for chronic GVHD Targeted launch strategy will be led by highly experienced Incyte and Syndax teams • Incyte to lead commercialization and contribute 70% of sales effort, leveraging their leadership in GVHD and ex
Slide 11: Axatilimab has a significant opportunity in 3L chronic GVHD in the U.S.
Axatilimab has a significant opportunity in 3L chronic GVHD 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 plan to target the ~6,500 progressing to later lines of treatment after two previous
Slide 12: Financial highlights and financial guidance
Financial highlights and financial guidance Ticker SNDX (NASDAQ) Cash and equivalents (30 June 2024) $455 M Shares outstanding* (30 June 2024) 85.3 M 2024 Operating Expense Guidance 3Q24 FY24 Research and development $70 – $75 M $240 – $260 M Total operating expenses^ $105 – $110 M $355 – $375 M * I
Slide 13: Accounting for net profits/losses on sales of axatilimab: Illustrative example
Accounting for net profits/losses on sales of axatilimab: Illustrative example Syndax will report collaboration profits on a net basis; Incyte will record product sales Net Profits: Axatilimab Assumption Syndax Illustrative P&L Net product sales of axatilimab $ 1,000 Collaborative Arrangement Revenu
Slide 14: Expected upcoming milestones
REVUMENIB Menin-KMT2A disruption • PDUFA action date of December 26, 2024, in R/R KMT2Ar acute leukemia; immediate launch • Pivotal data from AUGMENT-101 R/R mNPM1 cohort in 4Q24; potential sNDA filing in 1H25 • Present additional revumenib data in acute leukemias in 2H24 Expected • Initiation of pi
Slide 15: TON
ry, TON
Syndax Pharmaceuticals — Q2 2024 Earnings Presentation on 6ix