Syndax Pharmaceuticals, Inc. · NASDAQ:SNDX
Syndax Pharmaceuticals — Q2 2023 Earnings Presentation
13 slides from Syndax Pharmaceuticals's earnings presentation, Aug 3, 2023
Slide 1: SNDX Second Quarter 2023 Results
SNDX Second Quarter 2023 Results / August 3, 2023
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: Revumenib and axatilimab on-track to file an NDA and BLA in 2023
Revumenib and axatilimab on-track to file an NDA and BLA in 2023 with several opportunities for franchise expansion Revumenib Corporate Axatilimab and Menin-KMT2A Anti-CSF-1R Pipeline disruption Expand within acute leukemia Expand into earlier lines of Expand pipeline through and beyond to solid tum
Slide 4: Pivotal AUGMENT-101 trial: Expecting KMT2Ar topline data in 3Q23
Pivotal AUGMENT-101 trial: Expecting KMT2Ar topline data in 3Q23, enrollment completion for mNPM1 by YE23 Phase 1: Dose Phase 2: Ongoing Pivotal Trials Expected Milestones Escalation KMT2Ar KMT2Ar Enrollment AUGMENT-101-2A: KMT2Ar ALL sufficient for filing3 AUGMENT-101-2B: KMT2Ar AML Topline data 3Q
Slide 5: AUGMENT-101 Phase 1 data supports best-in-class profile for revumenib
AUGMENT-101 Phase 1 data supports best-in-class profile for revumenib Topline data from pivotal portion of AUGMENT-101 for KMT2Ar acute leukemia patients expected 3Q23 Overall response rate in 53% Phase 1 RP2D identified with and without concomitant strong CYP3A4i 27% CR/CRh rate in KMT2Ar* Median d
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 treatment paradigm Refractory Revumenib Clinical Development Program (KMT2Ar and mNPM1 Acute Leukemia) AUGMENT-101: Pivotal Rev
Slide 7: Revumenib expansion opportunities in acute leukemia have potential to add meaningful value
Revumenib expansion opportunities in acute leukemia have potential to add meaningful value Est. US market opportunity for Potential first/best-in-class agent mNPM1 and KMT2Ar AML Eligible • Clear activity in refractory, advanced patients 3 $4,000 12,000 mNPM1 and KMT2Ar acute leukemia • High percent
Slide 8: AGAVE-201, a global pivotal trial designed to identify an optimal dose of axatilimab
AGAVE-201, a global pivotal trial designed to identify an optimal dose of axatilimab in chronic GHVD patients 0.3 mg/kg Q2W* Inclusion criteria: Stratification factors: Randomization R/R • 2 years and older1 • Prior treatment with could provide a differentiated, practice-or 1:1:1 cGVHD 1 mg/kg Q2W*
Slide 9: AGAVE-201 results support axatilimab's promising safety and efficacy profile
AGAVE-201 results support axatilimab's promising safety and efficacy profile Reinforces its potential as a first-in-class CSF-1R monoclonal antibody in cGVHD 0.3 mg/kg every 2 weeks data highlights AGAVE-201 met its primary endpoint in cGVHD across all three cohorts ORR by cycle 7 day 1 74% (95% CI
Slide 10: AGAVE-201 positive results observed in a heavily pretreated, late stage cGVHD population
AGAVE-201 positive results observed in a heavily pretreated, late stage cGVHD population ROCKSTAR AGAVE-201 AGAVE-201 Population (ITT) N=132 N=241 Differentiation Age median (min, max), years 56 (21, 77) 53 (7, 81) Significantly Median time since cGVHD diagnosis 25.3 months 48 months longer time sin
Slide 11: Axatilimab has the 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* init YE23 ~335,000 WW2 2024 & Beyond Expansion into EU, Japan, ROW >35,000 WW1 ~14,000 US1 Expansion into 1st L chronic GVHD: 2024 Jakafi® combo
Slide 12: Financial highlights and financial guidance
Financial highlights and financial guidance Ticker SNDX (NASDAQ) Cash and equivalents (at 30 June 2023) $418.3 million Shares outstanding* (at 30 June 2023) 69.7 million 2023 Operating Expense Guidance 3Q 2023 FY23 (no change) Research and development $39 – $43 million $160 – $175 million Total oper
Slide 13: 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. 13
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