Enliven Therapeutics, Inc. · NASDAQ:ELVN
Enliven Therapeutics — EHA 2026 Congress
33 slides from Enliven Therapeutics's conference presentation, Jun 11, 2026
Slide 1: Company Presentation: EHA Update
Company Presentation EHA Update June 11, 2026
Slide 2: Disclaimer
Disclaimer This presentation contains forward-looking statements that involve substantial risks and uncertainties of Enliven Therapeutics, Inc. (“Enliven” or the “Company”). All statements other than statements of historical facts contained in this presentation, including statements regarding our fu
Slide 3: On Today's Call
On Today’s Call Rick Fair Helen Collins, M.D. Damiette Smit, M.D. Dennis Kim, M.D., Ph.D. Chief Executive Officer of Chief Medical Officer VP of Early Clinical Development Professor of Medicine, Enliven Therapeutics of Enliven Therapeutics of Enliven Therapeutics Department of Medical Oncology and H
Slide 4: Today's Agenda
Today’s Agenda 1 Introduction 2 Chronic Myeloid Leukemia (CML) Landscape & ELVN-001 Introduction 3 ELVN-001 Phase 1 Data Presented at EHA Congress 4 Key Takeaways and Next Steps for ELVN-001 5 Q&A 4
Slide 5: ELVN-001 Has the Potential to Be the Best-in-Class TKI in CML
ELVN-001 Has the Potential to Be the Best-in-Class TKI in CML Unique & Novel ATP-competitive BCR::ABL1 TKI with distinct binding and selectivity compared to the approved Complementary Design ATP-competitive inhibitors and differentiated mechanism compared to allosteric inhibitors Built for Designed
Slide 6: CML Landscape & ELVN-001 Introduction
CML Landscape & ELVN-001 Introduction
Slide 7: CML Is Now a Chronic Disease for Most Patients
CML Is Now a Chronic Disease for Most Patients BCR-ABL TKIs have profoundly extended survival, but unmet needs remain Unmet needs in CML… …drive real-world treatment changes Poor Tolerability Negatively Affects Quality of Life Switching Rates • Approved TKIs are associated with toxicities such as pl
Slide 8: Two Distinct Mechanisms to Treat CML – Yet Meaningful Gaps Remain
Two Distinct Mechanisms to Treat CML – Yet Meaningful Gaps Remain CML is a BCR-ABL driven disease, with two mechanistic approaches that offer different efficacy, tolerability, and resistance profiles ATP-Competitive TKIs Established the foundation for modern CML treatment • Dramatically improved ove
Slide 9: Approved ATP-Competitive TKIs Are Limited by Off-target Effects
Approved ATP-Competitive TKIs Are Limited by Off-target Effects Broad kinome inhibition by all approved ATP-competitive CML TKIs can lead to clinically meaningful toxicities Previously Approved ATP-Competitive TKIs Imatinib Dasatinib Nilotinib Bosutinib Ponatinib (Gleevec®) (Spyrcel®) (Tasigna®) (Bo
Slide 10: ELVN-001: Purpose-Built for Best-in-Class Potential in CML
ELVN-001: Purpose-Built for Best-in-Class Potential in CML Selectivity is the foundation of a molecule designed for lifelong CML treatment High Specificity Differentiated Design Novel binding mode and enhanced selectivity • Uniquely binds the P-loop “folded-in” active conformation of ABL1 • High spe
Slide 11: ELVN-001 Has the Potential to Compete Across All Lines of Therapy
ELVN-001 Has the Potential to Compete Across All Lines of Therapy Future treatment paradigm expected to sequence ATP-competitive inhibitors and allosteric inhibitors Treatment Pathways Market Insights and Assumptions Generic ATP- • ELVN-001 data suggest highly competitive efficacy, safety and ease o
Slide 12: Initial Pivotal Trial Creates Path to 2L+ CML Access
Initial Pivotal Trial Creates Path to 2L+ CML Access; Future Pivotal Trial Could Double the Opportunity U.S. Branded CML Market has the Potential to be ~$10B ELVN-001 2026 Key Milestones U.S. Patient Population: ~110K ✓ EHA Phase 1b data presentation ✓ End-of-Phase 1 meeting Phase 3 ENABLE-2 2L+ ~$5
Slide 13: ELVN-001 Is a Differentiated CML Inhibitor Expected to Begin a Phase 3 2L+ Pivotal Trial
ELVN-001 Is a Differentiated CML Inhibitor Expected to Begin a Phase 3 2L+ Pivotal Trial this Year Favorable Safety and Successful EOP1 Meeting Encouraging Efficacy Tolerability Profile Key outcomes of FDA meeting: ✓ 48% MMR achieved by 24 weeks at ✓ AE profile compares favorably to 80 mg QD precede
Slide 14: ELVN-001 Phase 1 Trial
ELVN-001 Phase 1 Trial EHA 2026 Presentation || 10 March 2026 Data Snapshot
Slide 15: ELVN-001: Phase 1 Trial Design and Status
ELVN-001: Phase 1 Trial Design and Status Key Eligibility Criteria: Primary Endpoints • Chronic phase CML • Incidence of DLTs, AEs, clinically significant laboratory and ECG abnormalities • Failed, intolerant to, or not a candidate Key Secondary Endpoints for available therapies known to be active f
Slide 16: Patient Demographics and Baseline Characteristics
Patient Demographics and Baseline Characteristics 80 mg QD 80 mg QD All Patients All Patients Parameter (Phase 1b) Parameter (Phase 1b) (N = 161a) (N = 161a) (N = 49) (N = 49) Median age in years (range) 59 (19–82) 57 (19–82) Median lines of prior TKI therapy, n (range) 4 (1–10) 3 (1–9) Typical BCR:
Slide 17: Patient Disposition: Majority of Patients Remain on Study
Patient Disposition: Majority of Patients Remain on Study 80 mg QD Overall, 146 person-years of exposure and 118 patients All Patients Disposition (Phase 1b) (N = 161) (N = 49) treated at doses ≥ 80 mg QD Median duration of 35 (0.1–156) 16.1 (0.3–86.7) exposure, weeks (range) At 80 mg QD in phase 1b
Slide 18: ELVN-001 had Favorable Safety and Tolerability
ELVN-001 had Favorable Safety and Tolerability All Patients 80 mg QD Most Common TEAEs (N = 158 Safety Analysis Set) (N = 62 Safety Analysis Set) • Wide therapeutic window (by Preferred Term), n (%) Any ≥ Grade 3 Any ≥ Grade 3 − 80 mg BID determined to be MTD: Any TEAE 142 (90%) 53 (34%) 51 (82%) 15
Slide 19: Encouraging Anti-CML Activity in Phase 1b
Encouraging Anti-CML Activity in Phase 1b Key Efficacy Milestones by Week 24 for Phase 1b Cumulative Incidence of MMR in Patients Not in MMR at Baseline Total QD 80 mg QD (Phase 1b) (Phase 1b) (N = 90) (N = 49) Rapid achievement of MMR Median exposure (weeks) 28.0 (0.3-86.7) 16.1 (0.3-86.7) MMR (BCR
Slide 20: All Patients in Phase 1b had Improved or Stable MR Category
All Patients in Phase 1b had Improved or Stable MR Category Change in BCR::ABL1 Transcript in Patients Evaluable for MMR by Week 24 (N = 69) Improvement in BCR::ABL1 transcript (%) at baseline MR category No category change ≥MR4.5 MR4 MR3 > 0.1 to 1 > 1 to 10 > 10 Worsening in MR ≤0.0032 > 0.0032 to
Slide 21: Encouraging MMR Rates Across Lines of Therapy and After Asciminib Failure
Encouraging MMR Rates Across Lines of Therapy and After Asciminib Failure MMR by Week 24: All Phase 1b QD MMR by Week 24: Post-Asciminib Phase 1b QD 80 Achieved Maintained* 70 67% 67% 60 • 65% (24/37) of patients 50% with prior asciminib 50 60% failed asciminib due to Patients, % 41% 40 38% lack of
Slide 22: Rapid Deep Molecular Response in Patient with Myristoyl Pocket Mutation
Rapid Deep Molecular Response in Patient with Myristoyl Pocket Mutation Patient Information Treatment-Emergent Adverse Events on ELVN-001 80 mg QD • 57-year-old female • Grade 1 diarrhea (R), Grade 1 dry skin (NR), Grade 2 sciatica (NR), • Primary diagnosis of CML in 2021 Grade 1 headache (NR), Grad
Slide 23: Major Molecular Response in Patient with T315I Mutation
Major Molecular Response in Patient with T315I Mutation Patient Information Treatment-Emergent Adverse Events on ELVN-001 80 mg BID • 72-year-old male • Grade 1 peripheral edema (R), Grade 1 bronchitis (NR), Grade 1 dry • Primary diagnosis of CML in 2023 skin (R), Grade 1 hypophosphatemia (R) • Pert
Slide 24: Conclusions
Conclusions Key take aways from the updated data ✓ The optimal biological dose (Phase 3 dose) was identified as 80 mg QD ✓ With longer follow-up and more patients enrolled, ELVN-001 showed a favorable safety profile, with low discontinuation rate due to adverse events, and most TEAEs being low grade
Slide 25: Key Takeaways and Next Steps for ELVN-001
Key Takeaways and Next Steps for ELVN-001
Slide 26: Patients Enrolled Materially Affect MMR Achievement Rates
Patients Enrolled Materially Affect MMR Achievement Rates Cross-Trial MMR comparisons require careful interpretation Differences in Enrollment Criteria Influence Patient Population Composition MMR Declines by Therapy Line Tern-701 / Achieved MMR rates based on precedent asciminib studies Asciminib
Slide 27: ELVN-001 Data Compares Favorably to the Last Two Approved Drugs in CML
To date, ELVN-001 Data Compares Favorably to the Last Two Approved Drugs in CML MMR Achievement by 24 Weeks N=21 80 mg QD Phase 1b 48% ELVN-001 N=53 All Phase 1b 40% N=157 Phase 3 27% Asciminib N=80 Phase 1 24% N=105 Phase 1 15% Bosutinib N=76 Phase 3 14% CML = Chronic myeloid leukemia. MMR = Major
Slide 28: Potentially Differentiated Safety & Tolerability Profile
Potentially Differentiated Safety & Tolerability Profile ELVN-001 Phase 1 Trial1 Scemblix USPI3 ELVN-001 Asciminib (N = 158) Compared with asciminib label Any Grade 3-4 Any Grade 3-4 • Lower rates of thrombocytopenia and Hematologic neutropenia Toxicity Laboratory Value % % % % • Lower rates of arte
Slide 29: Successful FDA Interaction Supports 2L+ Pivotal Trial Design
Successful FDA Interaction Supports 2L+ Pivotal Trial Design Key Outcomes from recent End-of-Phase 1 Meeting with the FDA ✓ 80 mg QD as recommended Phase 3 dose ✓ 2L+ patient population for Phase 3 trial ✓ Comparator arm of physician’s choice of ATP-competitive TKIs (excludes asciminib and ponatinib
Slide 30: ELVN-001 Data Supports Broad Registrational Development in CML
ELVN-001 Data Supports Broad Registrational Development in CML 24-week MMR has readthrough from Phase 1 to Phase 3 trials in relapsed/refractory CML ENABLE Phase 1 Trial ENABLE-2: Phase 3 2L+ CML Trial Previously treated Patients Expected initiation in 2H 2026 with CML Potential initial Anticipated
Slide 31: ELVN-001 Has the Potential to Be the Best-in-Class TKI in CML
ELVN-001 Has the Potential to Be the Best-in-Class TKI in CML Unique & Novel ATP-competitive BCR::ABL1 TKI with distinct binding and selectivity compared to the approved Complementary Design ATP-competitive inhibitors and differentiated mechanism compared to allosteric inhibitors Built for Designed
Slide 32: Thank you
Thank you
Slide 33: Q&A
Q&A