Olema Pharmaceuticals, Inc. · NASDAQ:OLMA
Olema Pharmaceuticals — JP Morgan Conference January 2024
28 slides from Olema Pharmaceuticals's conference presentation, Jan 8, 2024
Slide 1: Olema Oncology JP Morgan Conference January 2024
Olema Oncology JP Morgan Conference January 2024
Slide 2: Forward-Looking Statements
Forward-Looking Statements 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 statements. Such forwar
Slide 3: Olema's Mission to Transform Breast Cancer Treatment
Olema’s Mission to Transform Breast Cancer Treatment Potential best-in-class backbone endocrine therapy to improve outcomes for women with ER+/HER2- breast cancer 2024: Further unique combinability and execute on pivotal trial Complete Palazestrant – Ribociclib Phase 2 Study Enrollment with Updated
Slide 4: Palazestrant: A Differentiated Next Generation Endocrine Therapy
Palazestrant: A Differentiated Next Generation Endocrine Therapy Palazestrant, a complete estrogen receptor (ER) antagonist (CERAN), potently and completely inactivates the ER, blocks ER-driven transcriptional activity, inhibits ER-driven breast cancer cell growth, and strongly induces ER degradatio
Slide 5: Competing Programs and Market Opportunity for 2/3L and 1L MBC Treatment
Competing Programs and Market Opportunity for 2/3L and 1L MBC Treatment Current Active Programs 2L/3L ER+/HER2- MBC 1L Combo ER+/HER2- MBC * *Menarini’s drug ORSERDU (elacestrant) was approved by the U.S. FDA on January 27, 2023 for treatment of ER+/HER2- ESR1-mutated metastatic breast cancer follow
Slide 6: Pipeline: Palazestrant and KAT6 Inhibitor Programs
Preclinical Phase I Phase II Phase III Planned Next Steps Palazestrant (OP-1250) ER+/HER2- Metastatic Breast Cancer 2/3 Line Monotherapy Phase 3 trial initiated Q4 2023 Combo Therapy with CDK4/6i ribociclib Phase 2 expansion ongoing Combo Therapy with CDK4/6i palbociclib Phase 2 expansion ongoing Co
Slide 7: Palazestrant Phase 2 Monotherapy Clinical Results (ESMO 2023)
Palazestrant Phase 2 Monotherapy Clinical Results (ESMO 2023)
Slide 8: Monotherapy: Compelling PFS in ESR1-Mutant and Wild-Type Patients
Monotherapy: Compelling PFS in ESR1-Mutant and Wild-Type Patients Well tolerated, favorable PK and efficacy in heavily pretreated patients Palazestrant Phase 2 monotherapy clinical results at ESMO 2023 High oral bioavailability with daily dosing, dose proportional exposure and a long half-life of ei
Slide 9: Progression-Free Survival Across All and ESR1-Mutant Patients
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 38%
Slide 10: Comparing Across Trials: Palazestrant vs. Elacestrant
Comparing Across Trials: Palazestrant vs. Elacestrant Median Progression Free Survival and Clinical Benefit Rate EMERALD(1) Control Arm (n=238) Elacestrant(1) (EMERALD) (n=239) Palazestrant(2) (EMERALD-eligible) (n=49) Palazestrant (Phase 2 - All) (n=86) EMERALD(1) Control Arm (n=113) Elacestrant(1)
Slide 11: Progression-Free Survival in ESR1 Wild-Type Patients
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, pr
Slide 12: Monotherapy Competitive Landscape – Best-in-Class Potential
Monotherapy Competitive Landscape – Best-in-Class Potential Median PFS across comparable, all CDK4/6i-experienced patient populations * NOTE: This analysis is the aggregation of results across independent studies. There are risks inherent in conducting cross-trial comparisons. Refer to further discl
Slide 13: Phase 1b/2 Combination Clinical Results (SABCS 2023)
Phase 1b/2 Combination Clinical Results (SABCS 2023)
Slide 14: Phase 2 Combination Studies Ongoing with CDK4/6 Inhibitors
Phase 2 Combination Studies Ongoing with CDK4/6 Inhibitors Key* Inclusion Criteria: ER+/HER2- advanced breast cancer Evaluable disease (measurable and non-measurable) ≤ 1 (palbociclib) or ≤ 2 (ribociclib) prior hormonal regimen for locally advanced or metastatic disease * Full eligibility criteria f
Slide 15: Palbociclib Combination: Attractive Combinability with No DLTs, No DDIs
Palbociclib Combination: Attractive Combinability with No DLTs, No DDIs Preliminary efficacy signals and anti-tumor activity shown in both wild-type and ESR1 mutant Palbociclib combination Phase 1b/2 clinical results from SABCS 2023, enrollment ongoing No drug-drug interaction (DDI) between palbocic
Slide 16: Palazestrant Phase 1b/2 in Combination with Palbociclib: Safety
Palazestrant Phase 1b/2 in Combination with Palbociclib Well tolerated with no DLTs; No dose-related increase in TEAEs Most Common Treatment-Emergent Adverse Events TEAEs in ≥20% of Patients Olema Study 002 Palbociclib + Palazestrant(a) PALOMA-3 Comparison Palbociclib + Fulvestrant(b,c) (n=46) (n=34
Slide 17: Palazestrant Phase 1b/2 in Combination with Palbociclib: Anti-tumor Activity
Palazestrant Phase 1b/2 in Combination with Palbociclib Anti-tumor activity shown in both wild-type and ESR1 mutant patients Best percent change from baseline in target lesions and best overall response as of September 15, 2023a Data Cutoff Date: September 15, 2023 aEach lane represents one patient.
Slide 18: Preliminary Combination Clinical Benefit Rate in 2/3L+ Patients
Preliminary Combination Clinical Benefit Rate in 2/3L+ Patients PACE study indicated palbociclib rechallenge ineffective relative to fulvestrant control All Patients (n=12/26) ESR1mut (n=6/10) CDK4/6i Naïve (n=5/7) Benchmark Clinical Benefit Rate: Fulvestrant vs. Palbociclib + Fulvestrant Olema Stud
Slide 19: Palazestrant Palbociclib Combination – Potential Best-in-Class Combinability
Palazestrant Palbociclib Combination – Potential Best-in-Class Combinability Other SERDs in development have encountered challenges combining with CDK4/6 inhibitors * NOTE: This analysis is the aggregation of results across independent studies. There are risks inherent in conducting cross-trial comp
Slide 20: Ribociclib Combination: Combinability with the CDK4/6i-of-Preference
Ribociclib Combination: Combinability with the CDK4/6i-of-Preference No significant DDIs, no DLTs, overall safety profile consistent with expected of ribociclib plus ET Ribociclib Phase 1b combination data from SABCS 23, enrollment ongoing Palazestrant did not affect ribociclib drug exposure in pati
Slide 21: Palazestrant Phase 1b/2 in Combination with Ribociclib: Safety
Palazestrant Phase 1b/2 in Combination with Ribociclib Well tolerated with no DLTs; No grade 4 TEAEs reported Most Common Treatment-Emergent Adverse Events TEAEs in ≥20% of Patients Olema Study 003 Ribociclib + Palazestrant(a) MONALEESA-2 Ribociclib + Letrozole(b,c) (n=19) (n=334) All grades Grade
Slide 22: Palazestrant Phase 1b/2 in Combination with Ribociclib: Exposure
Palazestrant Phase 1b/2 in Combination with Ribociclib No significant effect on exposure levels No drug-drug interaction (DDI) between ribociclib and palazestrant in the dose range of 30 to 120 mg Palazestrant did not affect ribociclib 600 mg exposure when compared with published concentrations for
Slide 23: Ribociclib Only CDK4/6i with Confirmed OS Benefit in Combo with AI
Ribociclib Only CDK4/6i with Confirmed OS Benefit in Combo with AI CDK4/6is were approved with PFS but ribociclib has strongest evidence of OS benefit * NOTE: This analysis is the aggregation of results across independent studies. There are risks inherent in conducting cross-trial comparisons and re
Slide 24: Advancing in Pivotal Phase 3 Trials
Advancing in Pivotal Phase 3 Trials
Slide 25: OP-3136 – Olema KAT6 Inhibitor Development Candidate
OP-3136 – Olema KAT6 Inhibitor Development Candidate Anti-tumor Activity in Xenograft Models OP-3136 demonstrates anti-tumor activity in xenograft models KAT6 is a clinically validated target1 and its overexpression correlated with worse clinical outcome in ER+ breast cancer2 KAT6 inhibition downreg
Slide 26: OPERA-01 Phase 3 Trial Overview
OPERA-01 Phase 3 Trial Overview 510-patient 2/3L monotherapy trial vs. standard of care PRIMARY ENDPOINTS: PFS (BIRC) ESR1 mut PFS (BIRC) ESR1 mut-nd SECONDARY: PFS (local) ESR1 mut / ESR1 mut-nd / all ORR/CBR/DOR (BIRC and local) in ESR1 mut / ESR1 mut-nd / all STUDY END POINTS (Part 1 combined wit
Slide 27: Olema: A Compelling Late-Stage Opportunity in Women's Oncology
Olema: A Compelling Late-Stage Opportunity in Women’s Oncology Well-capitalized with ~$276.9M of cash and cash equivalents as of September 30, 20231 Palazestrant full-dose combinations with CDK4/6 inhibitors position it for first-line indication Palazestrant is highly differentiated within the new c
Slide 28: ir@olema.com | media@olema.com | partnering@olema.com
ir@olema.com | media@olema.com | partnering@olema.com careers@olema.com
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