Slide 1: Palazestrant in Combination with Ribociclib Clinical Update
Palazestrant in Combination with Ribociclib Clinical Update SABCS 2024 December 10, 2024 EXHIBIT 99.3
Slide 2: Legal disclaimer
Legal disclaimer 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. Words such as “antici
Slide 3: We are on a mission to elevate patient care in breast cancer and beyond
— We are on a mission to elevate patient care in breast cancer and beyond Expertise in endocrine-driven cancers with mechanistically superior scientific approach that fully inactivates estrogen receptors OP-1250, a promising potential backbone therapy for ER+/HER2- breast cancer in late-stage clinic
Slide 4: Rapidly advancing clinical pipeline
Rapidly advancing clinical pipeline Palazestrant second/third-line and first-line clinical trials in metastatic breast cancer Discovery Non-Clinical Phase 1 Phase 2 Phase 3 2nd/3rd line monotherapy Combo therapy with PI3Kαi alpelisib with PIK3CA mutated Combo therapy with mTOR inhibitor everolimus I
Slide 5: Phase 1b/2 study of palazestrant in combination with ribociclib (SABCS 2024 Poster)
“A Phase 1b/2 study of palazestrant (OP-1250) in combination with ribociclib, in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-), advanced or metastatic breast cancer” SABCS 2024 Poster #P2-09-16
Slide 6: Phase 1b/2 combination study design
Phase 1b/2 combination study design Key eligibility criteria Women or men with ER+/HER2– advanced or metastatic breast cancer Up to 2 prior endocrine therapies ± a CDK4/6i for locally advanced or metastatic disease; up to 1 prior line of chemotherapy for advanced or metastatic breast cancer was allo
Slide 7: Demographics
Demographics N=62; N=56 at 120 mg 58% with visceral disease 68% with measurable disease 77% received prior endocrine therapy in advanced setting 74% received prior CDK4/6i + ET 34 (55%) patients received 1 prior line of CDK4/6i Palbociclib, n=23; abemaciclib n=7 ribociclib, n=4 12 patients (19%) rec
Slide 8: Well tolerated with no DLTs; safety profile consistent with ribociclib + ET
Well tolerated with no DLTs; safety profile consistent with ribociclib + ET Treatment-emergent AEs TEAEs in ≥25% of patients Palazestrant + Ribociclib** MONALEESA-2* Letrozole + Ribociclib† (n = 62) (n = 334) All grades‡ Grade 3 Grade 4 All grades Grade 3 Grade 4 Neutropenia§ 51 (82%) 28 (45%) 6 (10
Slide 9: Six-month PFS rate of 73% in all patients, 68% in those with prior CDK4/6i
Six-month PFS rate of 73% in all patients, 68% in those with prior CDK4/6i Median follow-up of 12 months; median PFS not yet reached; 48% of patients remain on study Data cutoff date: November 11, 2024 * Follow up was calculated from first dose date to data cutoff date regardless of disease progre
Slide 10: Six-month PFS rate of 81% in ESR1-mutant patients, 70% in ESR1 wild-type
Six-month PFS rate of 81% in ESR1-mutant patients, 70% in ESR1 wild-type Median follow-up of 12 months; median PFS not yet reached; sustained efficacy regardless of ESR1 status Data cutoff date: November 11, 2024 * Follow up was calculated from first dose date to data cutoff date regardless of dise
Slide 11: Efficacy comparison in 2/3L patients vs. competitive landscape
Efficacy comparison in 2/3L patients vs. competitive landscape MAINTAIN study of ribociclib plus ET after CDK4/6i progression serves as best clinical benchmark* Six-Month PFS Rate* in CDK4/6i pre-treated patients MAINTAIN1: ET + Placebo (n = 59) Olema: Palazestrant + Ribociclib (n = 46) Interim effi
Slide 12: Compelling anti-tumor activity in both wild-type and ESR1 mutant tumors
Compelling anti-tumor activity in both wild-type and ESR1 mutant tumors 60% of patients showed tumor reduction 30 mg Treatment group (palazestrant dose): 60 mg 120 mg Treatment ongoing ESR1 mutation Prior AI Prior CDK4/6i Prior chemotherapy Prior fulvestrant Patients of efficacy population 40 20 0 -
Slide 13: Safety and Tolerability
Safety and Tolerability Palazestrant (120 mg) in combination with full dose ribociclib was well tolerated Safety was consistent with combinations of ribociclib (600 mg) with endocrine therapy Pharmacokinetics No clinically meaningful drug-drug interaction Efficacy Median follow-up of 12 months with
Slide 14: Proposed OPERA-02 1L Phase 3 pivotal trial in combination with ribociclib
Proposed OPERA-02 1L Phase 3 pivotal trial in combination with ribociclib ~1,000-patient trial vs. standard of care in preparation for 2025 initiation; in collaboration with Novartis CDK4/6i = cyclin-dependent kinase 4/6 inhibitor; CBR = clinical benefit rate; DOR = duration of response; ER+ = estro
Slide 15: Preparing to initiate OPERA-02 in 2025
Preparing to initiate OPERA-02 in 2025 New clinical trial collaboration and supply agreement with Novartis combined with $250M private placement enables execution of Olema operating plan Novartis agreement enables pivotal Phase 3 OPERA-02 clinical trial of palazestrant in combination with ribociclib
Slide 16: Significant opportunity for palazestrant across the spectrum of care
Significant opportunity for palazestrant across the spectrum of care Estimated >$20B ER+/HER2- global metastatic breast cancer market1 1 2025 opportunity estimates for total endocrine therapy market (US and Europe). Olema internal data. 2 2025 incidence projection estimates. Olema internal data, Inf
Slide 17: Olema: a compelling late-stage opportunity in breast cancer and beyond
Olema: a compelling late-stage opportunity in breast cancer and beyond Changing the treatment paradigm for endocrine-driven cancers 1 Pro forma position includes the Company's cash, cash equivalents, and marketable securities as of September 30, 2024, plus net proceeds of approximately $237.5 millio
Slide 18: Advancing medicines for breast cancer and beyond
— Advancing medicines for breast cancer and beyond