Syndax Pharmaceuticals, Inc. · NASDAQ:SNDX
Syndax Pharmaceuticals — Q3 2022 Earnings Presentation
12 slides from Syndax Pharmaceuticals's earnings presentation, Nov 3, 2022
Slide 1: 3Q22 Investor Presentation
Determined to realize a future in which people with cancer live longer and better than ever before 3Q22 INVESTOR PRESENTATION – NOVEMBER 3, 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
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 enrolling
: Revumenib pivotal trials in 3 distinct acute leukemia populations are enrolling 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: mNPM1 AML + up to
Slide 5: ASH 2022: Positive updates to Phase 1 portion of AUGMENT-101 trial
ASH 2022: Positive updates to Phase 1 portion of AUGMENT-101 trial Abstract #63 – Presentation on December 10th (9:30 – 11:00 AM CT) Efficacy Population Median duration of CR/CRh Best Response1 n = 60 (%) response of 9.1 mos Overall Response Rate2 32/60 (53%) Response CR 12 (20%) CR/CRh CRh 6 (10%)
Slide 6: ASH 2022: Durable remissions in transplant patients in AUGMENT-101 Phase 1
ASH 2022: Durable remissions in transplant patients treated in the Phase 1 portion of AUGMENT-101 trial Abstract #376 – Presentation on December 10th (4:00 – 5:30 PM CT) 12 patients proceeded to HSCT1 Patients who achieved MRDneg status 10/12 (83%) Remain in remission (1 receiving maintenance in CU2
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 MLLr 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 MLLr inhibition with
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 Eligible mNPM1 or MLLr AML patients 3 $4,000 • Clear activity in refractory, advanced 12,000 mNPM1 and MLLr acute leukemia •
Slide 9: Axatilimab pivotal trial enrollment complete; data expected in 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 has 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 4Q22 >35,000 WW1 Expansion into EU, Japan, ROW ~14,000 US1 Expansion to 1st L cGVHD: JAK combo trial 1Q2
Slide 11: Financial highlights and FY 2022 financial guidance
Financial highlights and FY 2022 financial guidance Ticker SNDX (NASDAQ) Cash, short- and long-term investments (as of September 30, 2022) $337.8 million Shares Outstanding* (as of September 30, 2022) 61.3 million 2022 Operating Expense Guidance FY 2022 Research and Development $115 – 125 million To
Slide 12: Thank you. Questions?
7 Thank you. Questi ons? ge
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