Syndax Pharmaceuticals, Inc. · NASDAQ:SNDX
Syndax Pharmaceuticals — Q1 2024 Earnings Presentation
14 slides from Syndax Pharmaceuticals's earnings presentation, May 8, 2024
Slide 1: First Quarter Financial Results Presentation
First Quarter Financial Results Presentation / May 8, 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: 1Q catalyst updates set the stage for a transformative 2024
1Q catalyst updates set the stage for a transformative 2024 Looking ahead in 2024 1Q milestones PDUFA action date of September 26, 2024, for revumenib, followed by launch Granted Priority Review for revumenib NDA submission under RTOR for R/R KMT2Ar PDUFA action data of August 28, 2024, for acute le
Slide 4: Pivotal AUGMENT-101 trial: KMT2Ar AML/ALL filing under Priority Review
Pivotal AUGMENT-101 trial: KMT2Ar AML/ALL filing under Priority Review; potential filing for mNPM1 in 1H25 Phase 1 Phase 2 Dose Escalation Ongoing Pivotal Trials Expected Milestones KMT2Ar KMT2Ar Enrollment completed AUGMENT-101-2A: KMT2Ar ALL Topline data AUGMENT-101-2B: KMT2Ar AML Adult and ped1 F
Slide 5: mNPM1 AML Phase 1 results suggest robust efficacy with durable, MRD-neg responses
mNPM1 AML Phase 1 results suggest robust efficacy with durable, MRDneg responses Phase 1 Dose Escalation 3/7 1 (43%) of responders patient restarted n (%) proceeded to HSCT revumenib post HSCT* Total mNPM1 @ RP2D 14 CR/CRh 5 (36%) 3/5 TRAEs MRDneg CR/CRh 5 (100%) patients achieving in-line with over
Slide 6: 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 mNPM1 & KMT2Ar Relapsed / acute leukemia Frontline Maintenance Refractory treatment paradigm Revumenib clinical development program (KMT2Ar and mNPM1 acute leukemia) - ongoing trials Pivotal
Slide 7: Axatilimab may be a practice-changing intervention for cGVHD
Axatilimab may be a practice-changing intervention for cGVHD Unique MOA for cGVHD High and durable ORR • First agent to target disease- causing macrophages to impact • 74% ORR at 0.3 mg/kg fibrosis & inflammation • 60% of patients treated at 0.3 mg/kg • Potential synergy with SOC remained in respons
Slide 8: Pre-launch priorities to maximize launch potential
Pre-launch priorities to maximize launch potential Developing an efficient, effective and purpose- 1 built infrastructure and customer-facing model 2 Ensuring market access and patient support services are available at time of launch Developing relationships with key stakeholders 3 including payors
Slide 9: Revumenib's profile supports use as backbone therapy: >$4B US market opportunity
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 ~ $2B market > $4B market Market Opportunity ($ B) ~ $1B market ~ $1.5 - $2B market R/R 1L “Unf
Slide 10: Axatilimab has potential to expand into additional high value indications
Axatilimab has the potential to expand into additional high value indications and new geographies Expansion into fibrotic indications: ~215,000 US IPF POC* ongoing ~335,000 WW2 2024 & Beyond Expansion into EU, Japan, ROW >35,000 WW1 R/R chronic GVHD: ~14,000 US1 PDUFA action date set for August 28,
Slide 11: Financial highlights and financial guidance
Financial highlights and financial guidance Ticker SNDX (NASDAQ) Cash and equivalents (31 March 2024) $522 M Shares outstanding* (31 March 2024) 85.3 M 2024 Operating Expense Guidance 2Q24 FY24 Research and development $50 – $55 M $240 – $260 M Total operating expenses^ $80 – $85 M $355 – $375 M * I
Slide 12: Accounting for net profits/losses on sales of axatilimab
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 Revenue
Slide 13: Expected upcoming clinical milestones
REVUMENIB Menin-KMT2A disruption • Approval and launch in R/R KMT2Ar acute leukemia in 2024 • Pivotal data from AUGMENT-101 mNPM1 cohort in 4Q24 • Update from Phase 1 metastatic CRC trial in 2Q24 • Additional data from revumenib Phase 1 combination studies (BEAT AML, SAVE Expected and AUGMENT-102) i
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