Syndax Pharmaceuticals, Inc. · NASDAQ:SNDX
Syndax Pharmaceuticals — Q2 2022 Earnings Presentation
13 slides from Syndax Pharmaceuticals's earnings presentation, Aug 8, 2022
Slide 1: 2Q22 Earnings Presentation – August 8, 2022
Determined to realize a future in which people with cancer live longer and better than ever before 2Q22 EARNINGS PRESENTATION – AUGUST 8, 2022
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 for potential filings in 2023 with several opportunities for expansion
Revumenib and axatilimab on-track for potential filings in 2023 with several opportunities for expansion Revumenib Axatilimab Pipeline Menin-MLL Anti-CSF-1R expansion disruption Expand within acute leukemia and Expand into earlier lines of cGVHD Expand pipeline through BD beyond to solid tumors and
Slide 4: Revumenib pivotal trials in 3 distinct acute leukemia populations are ongoing; data expected beginning in 1H23
: Revumenib pivotal trials in 3 distinct acute leukemia populations are ongoing; data expected beginning in 1H23 Independent, pivotal trials 64 adults AUGMENT-101 AUGMENT-101-2A: MLLr ALL + up to 10 peds R/R MLLr or 64 adults AUGMENT-101-2B: MLLr AML mNPM1 + up to 10 peds acute leukemia 64 adults AU
Slide 5: Targeted strategy to expand revumenib into earlier lines of therapy is underway
Targeted strategy to expand revumenib into earlier lines of therapy is underway Relapsed/Refractory Front-Line Maintenance Revumenib Development INTERCEPT trial AUGMENT-101: allows pts to Validates use of menin Trial Combination with restart Tx post-transplant inhibition in NPM1 and MLLr Description
Slide 6: Revumenib expansion opportunities in acute leukemia and solid tumors have potential to add meaningful value
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 Eligible mNPM1 or MLLr AML patients 3 $4,000 • Clear efficacy in refractory, advanced 12,000 mNPM1 and MLLr acute leukemia •
Slide 7: Axatilimab pivotal trial currently enrolling patients; data expected in 1H23
: Axatilimab pivotal trial currently enrolling patients; data expected in 1H23 Inclusion criteria: • 2 years and older1 0.3 mg/kg Q2W 70 patients Randomization • Recurrent or refractory active cGVHD after ≥ 2 lines of 1:1:1 R/R 1 mg/kg Q2W 70 patients systemic therapy cGVHD Stratification factors: 3
Slide 8: Axatilimab mediated monocyte / macrophage depletion may control inflammatory and fibrotic processes in the lung
Axatilimab mediated monocyte / macrophage depletion may control inflammatory and fibrotic processes in the lung Axatilimab Effect in Idiopathic Pulmonary Fibrosis (IPF) Circulating • IPF is a chronic fibrosing lung disease Blood inflammatory vessel Monocyte • Development and progression associated w
Slide 9: Anti-fibrotic effects of CSF-1R blockade extend to lung fibrosis
Anti-fibrotic effects of CSF-1R blockade extend to lung fibrosis Pre-clinical model shows significant reduction High levels of monocytes predicts poor in lung fibrosis1 clinical outcome3 Saline control Bleomycin Bleomycin + Ab535 2 Axatilimab Non-classical Intermediate Classical % monocyte (CD14+CD1
Slide 10: Axatilimab Phase 2b Global IPF trial planned for 4Q22
Axatilimab Phase 2b Global IPF trial planned for 4Q22; robust trial design includes key elements of a Phase 3 trial Key inclusion criteria: • FVC ≥ 45% predicted N Randomization Axatilimab • FEV1/FVC ≥ 0.7 85 patients Idiopathic 75mg Q2W • DLCO ≥30% PN Pulmonary 1:1 • Walk ≥ 150m during 6MWT Fibrosi
Slide 11: Axatilimab has the potential to expand into additional high value indications and new 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 4Q22 >35,000 WW1 Expansion into EU, Japan, ROW ~14,000 US1 Expansion to 1st L cGVHD: JAK combo trial 4Q2
Slide 12: Financial highlights, 3Q 2022 and FY 2022 financial guidance
Financial highlights, 3Q 2022 and FY 2022 financial guidance Ticker SNDX (NASDAQ) Cash, short- and long-term investments (as of June 30, 2022) $378.9 million Shares Outstanding* (as of June 30, 2022) 60.4 million 2022 Operating Expense Guidance Q3 2022 FY 2022 Research and Development $25 - 30 milli
Slide 13: Thank you. Questions?
7 Thank you. Questi ons? ge
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