Olema Pharmaceuticals, Inc. · NASDAQ:OLMA
Olema Pharmaceuticals — San Antonio Breast Cancer Symposium (SABCS) 2023
32 slides from Olema Pharmaceuticals's conference presentation, Dec 6, 2023
Slide 1: Olema SABCS December 2023 Presentation
Olema SABCS December 2023 Presentation December 6, 2023
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: Meeting Participants
Meeting Participants Sean P. Bohen, M.D., Ph.D. President and Chief Executive Officer Naseem Zojwalla, M.D. Chief Medical Officer Shane Kovacs, MBA Chief Operating Officer Presenting Q&A
Slide 4: Palazestrant: A Potential Best-in-Class Endocrine Therapy
Palazestrant (OP-1250) – A Potential Best-in-Class Endocrine Therapy Palazestrant combines well with CDK4/6 inhibitors In combination with CDK4/6 inhibitors, ribociclib and palbociclib, palazestrant showed no significant drug-drug interaction, no dose-limiting toxicities and a tolerability profile c
Slide 5: Phase 1b/2 Combination Clinical Studies
Phase 1b/2 Combination Clinical Studies
Slide 6: Combination Studies Ongoing with CDK4/6 Inhibitors
Palazestrant + Ribociclib Phase 2 Ongoing 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 metast
Slide 7: Palbociclib: Patient Characteristics
Palazestrant Phase 1b/2 in Combination with Palbociclib Of 46 patients, 72% had prior CDK4/6i treatment, 43% with baseline ESR1 mutations Patient Characteristics Total (N=46) Median age (years) 64 Range 30–77 ECOG performance status, n (%) 0 31 (67%) 1 15 (33%) Measurable disease at baseline, n (%)
Slide 8: Palbociclib: Well tolerated with no DLTs
Palazestrant Phase 1b/2 in Combination with Palbociclib Well tolerated with no DLTs; No dose-related increase in TEAEs TEAEs in ≥20% of Patients Olema Study 002 Palbociclib + Palazestrant(a) PALOMA-3 Comparison Palbociclib + Fulvestrant(b,c) All Doses (n=46) (n=345) All grades Grade 3 Grade 4 All
Slide 9: Palbociclib: Reduced AEs related to palazestrant or palbociclib
Palazestrant Phase 1b/2 in Combination with Palbociclib Reduced AEs related to palazestrant or palbociclib TRAEs in ≥20% of Patients Olema Study 002 Palbociclib + Palazestrant(a) All Doses (n=46) All grades Grade 3 Grade 4 Neutropeniab 40 (87%) 28 (61%) 5 (11%) Nausea 23 (50%) 0 0 Vomiting 12 (26%
Slide 10: Elacestrant Experience with Switching from Capsule to Tablet
Elacestrant Experience with Switching from Capsule to Tablet Potential to improve palazestrant upper GI tolerability with tablet formulation Elacestrant demonstrated less GI tolerability AEs with its tablet formulation vs. capsules1,2 All GI events were approximately halved in frequency with the tab
Slide 11: No effect of palazestrant on palbociclib exposure
Palazestrant Phase 1b/2 in Combination with Palbociclib No effect of palazestrant on palbociclib exposure levels across dose levels Pharmacokinetics Palbociclib (125mg) Steady State Exposure (AUC(0-24) and Cmax) (Alone and in Combination with Palazestrant (OP-1250)) No drug-drug interaction (DDI) be
Slide 12: No effect of palbociclib on palazestrant exposure
Palazestrant Phase 1b/2 in Combination with Palbociclib No effect of palbociclib on palazestrant exposure levels compared to monotherapy Palazestrant (OP-1250) Steady State Exposure (AUC0-24 and Cmax) (Alone and in Combination with Palbociclib (125 mg)) Pharmacokinetics No DDI between palbociclib an
Slide 13: Preliminary efficacy signals in wild-type and ESR1 mutant patients
Palazestrant Phase 1b/2 in Combination with Palbociclib Preliminary efficacy signals shown in both wild-type and ESR1 mutant patients Data Cutoff Date: September 15, 2023. aEach lane represents one patient. bTwo patients discontinued treatment due to patient decision; three discontinued due to physi
Slide 14: Anti-tumor activity in wild-type and ESR1 mutant patients
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 15: 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 16: Palbociclib Combination – Competitive Landscape
Palazestrant Palbociclib Combination – Competitive Landscape Other SERDs in development have encountered challenges combining with CDK4/6 inhibitors Treatment Palazestrant Camizestrant Giredestrant Vepdegestrant Study Phase 1b/2 Phase 1 (parts C/D) (SERENA-1) Phase 1b Phase 1b (part C) Dose 120 mg /
Slide 17: 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 Ribociclib * NOTE: This analysis is the aggregation of results across independent studies. There are risks inherent in conducting cross-trial compari
Slide 18: Phase 1b/2 Combination Study with Ribociclib
Phase 1b/2 Combination Study with Ribociclib + 1L+ ER+ MBC (CDK4/6 naïve or previously treated) 120mg palazestrant (RP2D) + Ribociclib 600 mg Ribociclib 600 mg Dose Expansion Dose Escalation Objectives: Safety, tolerability and antitumor activity of palazestrant at RP2D in combination with either ri
Slide 19: Ribociclib: Patient Characteristics
Palazestrant Phase 1b/2 in Combination with Ribociclib Of 19 patients, 89% had prior CDK4/6i treatment, 29% with baseline ESR1 mutations Patient Characteristics Total (N=19) Median age (years) 59 Range 37–85 ECOG performance status, n (%) 0 7 (37%) 1 12 (63%) Measurable disease at baseline, n (%) 12
Slide 20: Ribociclib: Well tolerated with no DLTs
Palazestrant Phase 1b/2 in Combination with Ribociclib Well tolerated with no DLTs; No grade 4 TEAEs reported TEAEs in ≥20% of Patients Olema Study 003 Ribociclib + Palazestrant(a) MONALEESA-2 Ribociclib + Letrozole(b,c) (n=19) (n=334) All grades Grade 3 Grade 4 All grades Grade 3 Grade 4 Nausea 1
Slide 21: Ribociclib: Reduced AEs related to palazestrant or ribociclib
Palazestrant Phase 1b/2 in Combination with Ribociclib Reduced AEs related to palazestrant or ribociclib TRAEs in ≥20% of Patients Olema Study 003 Ribociclib + Palazestrant(a) (n=19) All grades Grade 3 Grade 4 Neutropeniab 11 (58%) 7 (37%) 0 Nausea 11 (58%) 1 (5%) 0 WBC decr. 8 (42%) 2 (11%) 0 Ane
Slide 22: No effect of palazestrant on ribociclib exposure
Palazestrant Phase 1b/2 in Combination with Ribociclib No effect of palazestrant on ribociclib exposure levels across dose levels Pharmacokinetics Ribociclib (600mg) Steady State Exposure (AUC(0-24) and Cmax) (Alone and in Combination with Palazestrant (OP-1250)) No drug-drug interaction (DDI) betwe
Slide 23: Effect of ribociclib on palazestrant exposure not clinically meaningful
Palazestrant Phase 1b/2 in Combination with Ribociclib Effect of ribociclib on palazestrant exposure levels not clinically meaningful Palazestrant (OP-1250) Steady State Trough Concentration (Alone and in Combination with Ribociclib (600 mg)) (n=9) Pharmacokinetics Steady-state trough values overlap
Slide 24: Ribociclib: Preliminary efficacy data
Palazestrant Phase 1b/2 in Combination with Ribociclib Preliminary efficacy data, Data are maturing Confirmed partial response has been observed in one patient to date (30mg palazestrant) Longest duration of treatment is 34 weeks Efficacy data are maturing; 14/19 patients (74%) remain on treatment;
Slide 25: Advancing in Pivotal Phase Trials
Advancing in Pivotal Phase 3 Trials
Slide 26: Significantly Fewer Competing Programs for 2/3L and 1L MBC
Significantly Fewer Competing Programs for 2/3L and 1L MBC Treatment 10 Active Programs YE 2021 4 Active Programs YE 2023 2L/3L ER+/HER2- MBC 1L ER+/HER2- MBC 6 Active Programs YE 2021 4 Active Programs YE 2023 * *Menarini’s drug ORSERDU (elacestrant) was approved by the U.S. FDA on January 27, 2023
Slide 27: OPERA-01 Phase 3 Trial Overview
OPERA-01 Phase 3 Trial Overview 510-patient 2/3L monotherapy trial vs. standard of care KEY INCLUSION CRITERIA: ER+/HER2- mBC Evaluable disease (measurable or bone only) 1-2 prior lines of endocrine therapy Prior treatment with a CDK4/6 inhibitor Minimum 6 months on last ET PRIMARY ENDPOINTS: PFS (B
Slide 28: Steady State Exposures are Above Target
Palazestrant 90 mg and 120 mg Steady State Exposures are Above Target Dashed grey line =Target efficacious exposure based on estradiol supplemented preclinical models Cmin =226 ng/mL Dashed red line=Cmax for fulvestrant at steady stateb Steady-state Palazestrant Single Agent and Combination Dataa Hi
Slide 29: Advancing Palazestrant in Pivotal Phase Studies
Advancing Palazestrant in Pivotal Phase 3 Studies RP2D Selection Monotherapy Phase 1a Dose Escalation Phase 1b Dose Expansion Dose Expansion at 60 mg and 120 mg Completed Enrollment n=56 Phase 2 2L/3L Pivotal Phase 3 (OPERA-01) Expansion at RP2D of 120 mg Completed Enrollment; n=86 patients OPERA-01
Slide 30: Palazestrant: Best-in-Class Potential for ER+/HER2- Breast Cancer
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 pa
Slide 31: 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 Olema’s management team and board have deep experience and history of value creation Palazestrant combinability with CDK4/6 inhibitors positions it for
Slide 32: ir@olema.com | media@olema.com | partnering@olema.com careers@olema.com
ir@olema.com | media@olema.com | partnering@olema.com careers@olema.com
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