Syndax Pharmaceuticals, Inc. · NASDAQ:SNDX
Syndax Pharmaceuticals — Investor Presentation (March 2022)
20 slides from Syndax Pharmaceuticals's investor presentation, March 2022
Slide 1: 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 CORPORATE PRESENTATION | MARCH 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: 2021: Transformative year for Syndax
2021: Transformative year for Syndax Initiated AGAVE-201 and AUGMENT-101 pivotal trials Signed global partnership with Incyte for axatilimab Presented robust data for SNDX-5613 & axatilimab at ASH Completed $86.5 M financing 3
Slide 4: High value growth through pipeline development and continued asset acquisition
High value growth through pipeline development and continued asset acquisition SNDX-5613: Axatilimab: Menin-MLL Pipeline expansion Anti–CSF-1R disruption Expand beyond R/R acute leukemia Expand into earlier lines of cGHVD • Expand pipeline through BD and fibrotic disease • Pivotal trials (AUGMENT) o
Slide 5: SNDX-5613 turns off leukemic transcriptional programs offering potential therapeutic option
SNDX-5613 turns off leukemic transcriptional programs offering potential therapeutic option in patients with clear need Gene transcription ON MLLr and mNPM1 Acute Leukemia Menin Annual global incidence ~25,000 MLL* GENE Leukemia 35-40% AML In presence of Menin inhibitor 10-15% ALL SNDX-5613 • 5-year
Slide 6: AUGMENT-101: Phase 1/2 trial of SNDX-5613, in patients with acute leukemia
AUGMENT-101: Phase 1/2 trial of SNDX-5613, in patients with acute leukemia Phase 1: Dose escalation Phase 2: Expansion Arm A 339 mg (no strong CYP3A4i) q12h 276 mg AUGMENT-101-2A: MLLr ALL 226 mg q12h q12h 113 mg Adult and ped1 q12h AUGMENT-101-2B: MLLr AML with R/R MLLr or mNPM1 acute leukemia Arm
Slide 7: SNDX-5613 was well-tolerated across all doses
SNDX-5613 was well-tolerated across all doses Any-grade treatment-related AE Safety Pop Safety Pop ≥Grade 3 treatment-related AE (≥5%) n=59 n=59 All Grade ≥Gr 3 treatment-related AE, n(%) 11 (19) ≥1 treatment-related AE, n(%) 46 (78) ECG QTc prolonged 7 (12) 7% of pts (3/43) reported Gr 3 ECG QTc pr
Slide 8: SNDX-5613 demonstrates promising antileukemic activity in relapsed/refractory MLLr and mNPM1 leukemias
SNDX-5613 demonstrates promising antileukemic activity in relapsed/refractory MLLr and mNPM1 leukemias Efficacy Population Best Response n = 51 (%) Overall Response Rate1 28/51 (55%) Response CR 8 (16%) CR/CRh 12 (24%) CRh 4 (8%) CRp 7 (14%) MLFS 9 (18%) CRc MRDneg Rate2 16/51 (31%) mNPM1 MLLr MRDne
Slide 9: AUGMENT-101 registration trials underway in 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 10: Trials testing expanded opportunities for SNDX-5613 to initiate in 1H22
Trials testing expanded opportunities for SNDX-5613 to initiate in 1H22 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; MRD positive mNPM1 or MLLr AML mNPM1 or MLLr AML/ALL mNPM1 or MLLr AM
Slide 11: SNDX-5613: moving into frontline meaningfully expands market potential
SNDX-5613: moving into frontline meaningfully expands market potential with additional patients and increasing duration of Tx Potential best/first-in-class agent • Clear efficacy in refractory, advanced NPM1 and MLLr acute leukemia • High percentage of MRD negative responses Profile supports use in
Slide 12: Axatilimab inhibition reduces pathogenic monocytes and macrophages
Axatilimab inhibition reduces pathogenic monocytes and macrophages CSF-1 CSF-1R Circulating Monocyte Chronic graft versus host disease: Blood vessel Circulating Monocyte • Develops in 40% of HSCT1; estimated US CSF-1R prevalence ~14,0002 CSF-1 CSF-1R • Immune mediated systemic disease Circulating wi
Slide 13: Axatilimab: CSF-1R mAb with potential best-in-class profile
Axatilimab: CSF-1R mAb with potential best-in-class profile Enrolled cGVHD pts progressed on 2 or more prior therapies Phase 1: Dose Escalation Cohort 4 Phase 2: Expansion 17 pts enrolled n=6 1mg/kg q2wk Cohort 3 3.0 mg/kg n=3 q2wks 23 patients enrolled Cohort 2 n=1 1.0 mg/kg Cohort 5 Cohort 1 q2wks
Slide 14: Incidence of related AEs demonstrates tolerability
Incidence of related AEs demonstrates tolerability All related Grades in ≥20% All related Grade 3/4 1mg/kg 3 mg/kg 1mg/kg 3 mg/kg All All patients Q2W Q4W Q2W Q4W patients N=40 n=26 n=6 n=26 n=6 N=40 Related Related Gr 3/4 17 (65) 5 (83) 29 (73) 2 (9) 2 (33) 8 (20) TEAE, n (%) TEAE, n (%) AST increa
Slide 15: Rapid and durable responses in doses advanced to pivotal trial
Rapid and durable responses in doses advanced to pivotal trial 1mg/kg 3 mg/kg Total Response Q2W Q4W N=31 3 mg/kg q4w evaluable n=25 n=6 Best ORR, n(%) 18 (72) 3 (50) 21 (68) Time to 0.9 0.9 0.9 response, mo (0.9, 11) (0.9, 1.9) (0.9, 11) 1 mg/kg q2w Time on 6.7 7.7 6.7 Phase 2 treatment, mo (0.9, 2
Slide 16: AGAVE-201: 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 older1 R/R 1:1:1 1 mg/kg Q2W 70 patients cGVHD • Recurrent or refractory active 3 mg/kg Q4W 70 patients cGVHD after at least 2 lines of systemic FPFV in Topline the
Slide 17: Partnership with Incyte enables expansion into additional high value indications
Partnership with Incyte enables expansion into additional high value indications and new geographies Prevalence estimates ~215,000 US, ~335,000 WW2 Expansion into fibrotic indications: IPF Phase 2* >35,000 WW1 Expansion into EU, Japan, ROW ~14,000 US1 Expansion to 1st L cGHVD: JAK combo trial AGAVE-
Slide 18: Business development: core strength of our business
Business development: Proven ability to build the core strength of our business pipeline From UCB Active search for late pre-clin / phase 1 targeted oncology assets Axatilimab Established relationships enhance identification and access to quality assets From Allergan/Vitae Expertise in translational
Slide 19: 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 December 31, 2021) $439.9 million Shares Outstanding* (as of December 31, 2021) 59.0 million 2022 Operating Expense Guidance Q1 2022 FY 2022 Research and Development $30-35 millio
Slide 20: Thank you. Questions?
7 Thank you. Questi ons? ge
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