Syndax Pharmaceuticals, Inc. · NASDAQ:SNDX
Syndax Pharmaceuticals — Q1 2022 Earnings Presentation
14 slides from Syndax Pharmaceuticals's earnings presentation, May 2022
Slide 1: 1Q22 Earnings Presentation
Determined to realize a future in which people with cancer live longer and better than ever before 1Q22 EARNINGS PRESENTATION
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
Revumenib and axatilimab on-track for potential filings in 2023 Revumenib* Axatilimab Menin-MLL Pipeline expansion Anti–CSF-1R disruption • Expand within acute leukemia and • Expand into earlier lines of cGVHD • Expand pipeline through BD beyond to solid tumors and fibrotic disease • Targeting asset
Slide 4: AUGMENT-101 registration trials underway in 3 distinct patient populations
AUGMENT-101 registration trials underway in 3 distinct patient populations 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 AUGMENT-101-2C: NPM1 mut AML + up to 10
Slide 5: Expanding development into new populations with BEAT-AML and AUGMENT-102
Expanding development into new populations with initiation of BEAT- AML and AUGMENT-102, INTERCEPT to follow in 2Q22 BEAT-AML: AUGMENT-102: INTERCEPT: Frontline Ven/Aza combo R/R Chemo combo MRD-progression in AML Phase 1/3; Frontline Phase 1; Relapsed or refractory Phase 1; Post-frontline setting m
Slide 6: Moving into frontline treatment meaningfully expands market potential
Moving into frontline treatment meaningfully expands market potential Est. US market opportunity for Potential first/best-in-class agent mNPM1 or MLLr AML Eligible • Clear efficacy in refractory, advanced patients 3 $4,000 NPM1 and MLLr acute leukemia 12,000 • High percentage of MRD negative respons
Slide 7: MLL1 regulates b-catenin driven transcription of CRC growth and resistance genes
MLL1 regulates b-catenin driven transcription of CRC growth and resistance genes • CRC: 3rd most frequently diagnosed cancer and 2nd leading cause of cancer deaths1 • Significant need for novel targeted agents that improve survival in metastatic disease • More than 55,000 patients per year diagnosed
Slide 8: Menin-MLL interaction may be required for b-catenin driven tumors
Menin-MLL interaction may be required for b-catenin driven tumors b-catenin driven CRC Menin inhibition with revumenib revumenib Menin TCF MLL1 TCF Menin MLL1 β-catenin β-catenin target genes MYC, Cyclins, target genes ON AXIN2 OFF Differentiation upregulation Gene transcription ON Gene transcriptio
Slide 9: Phase 1 signal seeking trial to assess efficacy in MSS CRC
Phase 1 signal seeking trial to assess efficacy in MSS CRC Initiation expected 4Q22 Phase 2: Single Arm trial (accelerated approval) Primary endpoint: MSS CRC Phase 1: ORR and DOR Dose confirm and signal seeking OR Primary endpoint: Safety, ORR and DCR at cycle 6 Phase 2: Randomized Trial vs SOC* (f
Slide 10: Ongoing global pivotal trial for axatilimab in chronic GVHD
: ongoing global pivotal trial for axatilimab in chronic GVHD Inclusion criteria: 0.3 mg/kg Q2W 70 patients Randomization • 2 years and older R/R 1:1:1 1 mg/kg Q2W 70 patients cGVHD • Recurrent or refractory 3 mg/kg Q4W 70 patients active cGVHD after at least 2 lines of systemic FPFV in Topline ther
Slide 11: Partnership with Incyte enables expansion into additional high value indications and new geographies
Partnership with Incyte enables expansion 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
Slide 12: Proven ability to build the pipeline
Proven ability to build the pipeline From UCB Business development continues to be a core strength of our business Axatilimab Clinical development leadership enables competitive advantage From Allergan/Vitae Established relationships enhance Menin-MLL identification and access to quality assets inhi
Slide 13: Financial highlights, 1Q 2022 and FY 2022 financial guidance
Financial highlights, 1Q 2022 and FY 2022 financial guidance Ticker SNDX (NASDAQ) Cash and short-term investments (as of March 31, 2022) $397.9 million Shares Outstanding* (as of March 31, 2022) 59.0 million 2022 Operating Expense Guidance Q2 2022 FY 2022 Research and Development $30-35 million $130
Slide 14: Thank you. Questions?
7 Thank you. Questi ons? ge
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