Slide 1: ESMO 2023 Palazestrant Phase 2 Monotherapy Clinical Study Results
1 ESMO 2023 Palazestrant Phase 2 Monotherapy Clinical Study Results October 23, 2023
Slide 2: Forward-Looking Statements and Other Disclaimers
2 Forward-Looking Statements and Other Disclaimers This presentation contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are forward-looking
Slide 3: Meeting Participants
3 Meeting Participants Sean P. Bohen, M.D., Ph.D. President and CEO Naseem Zojwalla, M.D. Chief Medical Officer Shane Kovacs, MBA Chief Operating & Financial Officer Dr. Nancy Lin, M.D. Associate Chief of the Division of Breast Oncology, Susan F. Smith Center for Women’s Cancers Dana-Farber Cancer I
Slide 4: Palazestrant (OP-1250) – A Potential Best-in-Class Endocrine Therapy
4 Palazestrant (OP-1250) – A Potential Best-in-Class Endocrine Therapy • Completely shuts-down estrogen receptor signaling pathways, both wild type and ESR1-mutant • A potential backbone therapy across multiple lines of ER+/HER2- metastatic breast cancer (1L and 2/3L) • Well tolerated with clinical
Slide 5: Palazestrant Phase 2 Monotherapy Clinical Study Results
5 Palazestrant Phase 2 Monotherapy Clinical Study Results
Slide 6: Palazestrant First-in-Human Phase 1/2 Study Design
6 Palazestrant (OP-1250) First-in-Human Phase 1/2 Study Design More Than 150 Patients Treated with Palazestrant in Monotherapy Setting Objectives: Efficacy, safety and tolerability at RP2D Primary objectives: Pharmacokinetics, safety and tolerability, RP2D Secondary objectives: ORR (CR + PR), CBR (C
Slide 7: Patient Demographics and Baseline Characteristics
7 Patient Demographics and Baseline Characteristics Patients Received Extensive Prior Therapies Characteristics 120 mg palazestrant N=86* Age, median, years (range) 61 (32-85) Pre- or peri-menopausal, n (%) 7 (8%) ECOG performance status, n (%) 0 46 (54%) 1 40 (47%) Measurable disease at baseline, n
Slide 8: Safety – Treatment Emergent Adverse Events
8 Safety – Treatment Emergent Adverse Events Palazestrant is well tolerated with most TEAEs Grade 1 / 2 • Most AEs were low grade (grade 1/2) • Events of grade 4 neutropenia were observed in 6 patients at 120 mg, occurring approximately 4–6 weeks into therapy − 3 patients had a dose interruption fol
Slide 9: Safety – Treatment Related Adverse Events
9 Safety – Treatment Related Adverse Events Data Cutoff Date: July 7, 2023 Abbreviations: AE, adverse event; TEAE, treatment-emergent adverse event; TRAE, treatment-related adverse event; AST, aspartate aminotransferase. TRAEs in ≥15% of patients 120 mg palazestrant (n=83) Grade 1 Grade 2 Grade 3 Gr
Slide 10: Duration of Treatment
10 Duration of Treatment Clinical Benefit Rate of 40% Overall; 52% with ESR1 Mutations; 32% in ESR1 Wild-type Clinical Benefit Rate at 120 mg: • All patients: 40% (32/81) • ESR1 mutation: 52% (17/33) • ESR1 wild-type: 32% (12/38) • 3 cPRs and 2 uPRs† in 66 response-evaluable patients Treatment durat
Slide 11: Progression-Free Survival Across All and ESR1-Mutant Patients
11 Progression-Free Survival Across All and ESR1-Mutant Patients Median PFS of 7.2 months overall; 7.3 months in ESR1 mutations in EMERALD-eligible 2/3L ± CT Patients* All Patients Patients with ESR1 Mutation All n=86 2/3L ±CT n=49 Median PFS, mos [95% CI] 4.6 [3.5, 6.5] 7.2 [3.7, 7.8] 6-month PFS 3
Slide 12: Comparing Across Trials: Palazestrant vs. Elacestrant
12 Comparing Across Trials: Palazestrant vs. Elacestrant Median Progression Free Survival and Clinical Benefit Rate 1.9 2.8 4.6 7.2 0 2 4 6 8 EMERALD(1) Control Arm (n=238) Elacestrant(1) (EMERALD) (n=239) Palazestrant(2) (EMERALD-eligible) (n=49) Palazestrant (Phase 2 - All) (n=86) 1.9 3.8 5.6 7.3
Slide 13: Progression-Free Survival in ESR1 Wild-Type Patients
13 Progression-Free Survival in ESR1 Wild-Type Patients Median PFS of 5.5 months in EMERALD-eligible 2/3L ±CT Patients* Abbreviations: 2/3L, second/third line; ± CT, plus/minus chemotherapy; WT, wild-type; CI, confidence interval; ESR1, estrogen receptor 1 gene; mos, months; NA, not applicable; PFS,
Slide 14: Palazestrant in the Competitive Landscape – Potential Best-in-Class
14 Palazestrant in the Competitive Landscape – Potential Best-in-Class Baseline Patient Characteristics Vary Across Competitor Landscape / Studies* Treatment Palazestrant Elacestrant Camizestrant Giredestrant Vepdegestrant Sponsor Olema Menarini AstraZeneca Roche Pfizer / Arvinas Study Phase 2 Phase
Slide 15: Palazestrant in the Competitive Landscape - Best-in-Class Potential
15 Palazestrant in the Competitive Landscape - Best-in-Class Potential Median Progression Free Survival Across Comparable, All CDK4/6i-Experienced Patient Populations 1.9 2.8 3.5 3.7 7.2 - 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 * NOTE: This analysis is the aggregation of results across independent studies.
Slide 16: Perspectives on the SERD Landscape
16 Perspectives on the SERD Landscape Dr. Nancy U. Lin
Slide 17: Perspectives on Palazestrant as a Next Generation Endocrine Therapy
17 Perspectives on Palazestrant as a Next Generation Endocrine Therapy • Endocrine therapy remains the backbone of treatment for ER+/HER2- breast cancer ‒ Shutting off estrogen receptor signaling is a key objective ‒ Add additional agents as resistance develops but continue to suppress ER signaling
Slide 18: Summary
18 Summary
Slide 19: Palazestrant (OP-1250): Best-in-Class Potential for ER+/HER2- Breast Cancer
19 Palazestrant (OP-1250): Best-in-Class Potential for ER+/HER2- Breast Cancer CNS Penetration Attractive PK Profile Combinability w/ CDK4/6i Complete ER Antagonism Clinical dataset with over 225 patients treated with palazestrant supports opportunity in both monotherapy and combination settings for
Slide 20: Phase 2 Combination Studies Ongoing with Palbociclib & Ribociclib
20 Palazestrant - Ribociclib Phase 2 Ongoing Phase 2 Combination Studies Ongoing with Palbociclib & Ribociclib Key Inclusion Criteria: • ER+/HER2- advanced breast cancer • Evaluable disease (measurable and non-measurable) • ≤ 1 prior hormonal regimen for locally advanced or metastatic disease Object
Slide 21: ER+/HER2- Breast Cancer: One of the Largest Commercial Markets in Oncology
21 ER+/HER2- Breast Cancer: One of the Largest Commercial Markets in Oncology 12025 incidence projection estimates. Olema internal data, Informa ER+/HER2- BC Prevalence Based Market Forecast. 26% of adjuvant eligible patients assumed to have Ki-67 ≥ 20%. Early breast cancer incidence includes high r
Slide 22: Precedent Oncology Drug Launches
22 Precedent Oncology Drug Launches Elacestrant Launch On-track to Rival Top Oncology Product Launches $400M+ Annualized Sales 6 months into Launch ORSERDU (Elacestrant) Gross Sales1 US Quarterly Drug Sales ($M) 1 Source: Symphony data. $900M $800M $700M $600M $500M $400M $300M $200M $100M $0M US Mo
Slide 23: Palazestrant Development Pipeline and Planned Next Steps
23 Preclinical Phase I Phase II Phase III Planned Next Steps Palazestrant (OP-1250) ER+/HER2- Metastatic Breast Cancer 2/3 Line Monotherapy OPERA-01 Phase 3 trial initiation Q4 2023 Combo Therapy with CDK4/6i ribociclib Phase 2 expansion ongoing Combo Therapy with CDK4/6i palbociclib Phase 2 expansi
Slide 24: Olema: A Compelling Late-Stage Opportunity in Women’s Oncology
24 Olema: A Compelling Late-Stage Opportunity in Women’s Oncology Well-capitalized with ~$297.4M of cash and cash equivalents as of June 30, 20231 Olema’s management team and board have deep experience and history of value creation Palazestrant combinability with CDK4/6 inhibitors positions it for a
Slide 25: Thank you
Thank you
Slide 26: Comparing Across Trials: 6-Month Progression Free Survival Rate
26 Comparing Across Trials: Palazestrant vs. Elacestrant 6-Month Progression Free Survival Rate 6-Month PFS Rate (%) – All Patients* 6-Month PFS Rate (%) – ESR1 Mutant Patients* 20% 34% 38% 54% 0% 10% 20% 30% 40% 50% 60% 70% 19% 41% 46% 62% 0% 10% 20% 30% 40% 50% 60% 70% EMERALD(1) Control Arm (n=23
Slide 27: Palazestrant in the Competitive Landscape: PRs and ORR
27 Palazestrant in the Competitive Landscape PRs and ORR in CDK4/6i-Experienced Patients Sponsor Molecule Study Dose # cPRs # Evaluable ORR Olema Palazestrant1 Phase 2 120 mg 3 66 4.5% Menarini Control Arm2 EMERALD NA 8 182 4.4% Menarini Elacestrant2 EMERALD 400 mg 8 179 4.5% Pfizer / Arvinas Vepdeg