Syndax Pharmaceuticals, Inc. · NASDAQ:SNDX
Syndax Pharmaceuticals — Q4 2022 Earnings Presentation
13 slides from Syndax Pharmaceuticals's earnings presentation, Feb 28, 2023
Slide 1: 4Q and FY22 Corporate Presentation
Determined to realize a future in which people with cancer live longer and better than ever before 4Q AND FY22 CORPORATE PRESENTATION |FEBRUARY 28, 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: 2022: A year of growth and execution
2022: A year of growth and execution • Awarded BTD in patients with R/R KMT2Ar acute leukemia Revumenib • Presented robust Phase 1 data in two oral sessions at ASH 2022 Menin-MLL disruption • Initiated R/R frontline and combination trials in acute leukemias • Published Phase 1/2 data in cGVHD in the
Slide 4: Revumenib and axatilimab on-track to file potential marketing applications in 2023
Revumenib and axatilimab on-track to file potential marketing applications in 2023 with several opportunities for expansion Revumenib Corporate Axatilimab and Menin-MLL Anti-CSF-1R Pipeline disruption Expand within acute leukemia and Expand into earlier lines of cGVHD Expand pipeline through BD beyo
Slide 5: Pivotal AUGMENT-101 trial: KMT2Ar topline data in 3Q23, mNPM1 enrollment completion 2H23
Pivotal AUGMENT-101 trial: expecting KMT2Ar topline data in 3Q23, enrollment completion for mNPM1 in 2H23 Phase 1: Dose Phase 2: Ongoing Pivotal Trials Expected Milestones Escalation KMT2Ar Enrollment AUGMENT-101-2A: KMT2Ar ALL sufficient for filing2 Adult and ped1 AUGMENT-101-2B: KMT2Ar AML Topline
Slide 6: Updated AUGMENT-101 data supports best-in-class profile for revumenib
Updated AUGMENT-101 data presented at the ASH meeting continues to support best-in-class profile for revumenib Efficacy Population Best Response1 • Median duration of CR/CRh n = 60 (%) response of 9.1 mos Overall Response Rate2 32/60 (53%) CR 12 (20%) • Median time to CR/CRh Response CRh 6 (10%) res
Slide 7: Trials underway to establish revumenib as a backbone of treatment
Trials underway to establish revumenib as a backbone of treatment for mNPM1 or KMT2Ar acute leukemia Relapsed/Refractory Front-Line Maintenance Revumenib Development INTERCEPT trial Validates use of menin Validates the use of menin AUGMENT-101: allows pts to inhibition in NPM1 and inhibition with Tr
Slide 8: Revumenib expansion opportunities in acute leukemia and solid tumors
Revumenib expansion opportunities in acute leukemia and solid tumors 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 leukem
Slide 9: Axatilimab pivotal trial enrollment complete; data expected mid-23
: Axatilimab pivotal trial enrollment complete; data expected in mid-23 Inclusion criteria: • 2 years and older1 0.3 mg/kg Q2W Randomization • Recurrent or refractory active R/R cGVHD after ≥ 2 lines of 1:1:1 cGVHD 1 mg/kg Q2W systemic therapy N = ~ 240 Stratification factors: 3 mg/kg Q4W • Prior th
Slide 10: Axatilimab: Phase 1/2 POC trial in cGVHD showed rapid and durable responses
Axatilimab: Phase 1/2 POC trial in cGVHD showed rapid and durable responses Phase 2 cohort Individual responses and durability of Cumulative response rate in highlights Phase 2 cohort cGVHD-involved organs ORR by cycle 82% 7 day 1 FFS at 12 77% months Median time 4 wks to response Responses observed
Slide 11: Axatilimab potential to expand into additional indications and geographies
Axatilimab has the potential to expand into additional high value indications and new geographies Prevalence estimates ~215,000 US, Expansion into ~335,000 WW2 fibrotic indications: IPF POC* init 1H23 >35,000 WW1 Expansion into EU, Japan, ROW ~14,000 US1 Expansion to 1st L cGVHD: JAK combo trial 1Q2
Slide 12: Financial highlights and 2023 financial guidance
Financial highlights and 2023 financial guidance Ticker SNDX (NASDAQ) Cash and equivalents (as of December 31, 2022) $481.3 million Shares outstanding* (as of December 31, 2022) 69.3 million 2023 Operating Expense Guidance Q1 2023 FY 2023 Research and development $30 – $35 million $160 – $175 millio
Slide 13: Thank you. Questions?
7 Thank you. Questi ons? ge
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