Olema Pharmaceuticals, Inc. · NASDAQ:OLMA
Olema Pharmaceuticals — Investor Presentation (September 2024)
30 slides from Olema Pharmaceuticals's investor presentation, Sep 27, 2024
Slide 1: Advancing medicines for breast cancer and beyond: Corporate Overview
Advancing medicines for breast cancer and beyond Corporate Overview September 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. Words such
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 backbone therapy for ER+/HER2- breast cancer in late-stage clinical develop
Slide 4: What drives us: we are all impacted by breast cancer
What drives us: we are all impacted by breast cancer The most common cancer diagnosed and the second leading cause of cancer death among women Women in the U.S. will be diagnosed with invasive breast cancer in her lifetime Estimated women in the U.S. that will be diagnosed with breast cancer in 2024
Slide 5: Today's therapies are insufficient to meet patient needs
Today’s therapies are insufficient to meet patient needs Patient outcomes reflect limitations and discontinuations of currently available therapies Source: National Breast Cancer Foundation, World Health Organization; American Cancer Society. Facts and Figures 2024; SEER database ER = estrogen recep
Slide 6: Palazestrant (OP-1250) has the attributes of a therapeutic class leader
Palazestrant (OP-1250) has the attributes of a therapeutic class leader A differentiated oral CERAN—a complete estrogen receptor antagonist—targeting metastatic breast cancer with experience in over 400 patients to date Once-daily oral delivery Favorable tolerability Combinability Complete ER antago
Slide 7: 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 EU5). Olema internal data. 2 2025 incidence projection estimates. Olema internal data, Inform
Slide 8: 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 9: Strategy driven by leaders positioned to go the distance
Strategy driven by leaders positioned to go the distance Oncology and industry experts with track record of advancing programs from clinical to commercial Executive Leadership Team Ian Clark Chairman of the Board Sean Bohen, M.D., Ph.D. President and CEO Sandra Horning, M.D., FACP, FASCO Cindy Butit
Slide 10: Corporate priorities and anticipated milestones
2H 2024 2025 2026 Execute OPERA-01 pivotal Phase 3 2/3L monotherapy trial Enroll palazestrant-everolimus Phase 1b/2 clinical study Present OP-3136 KAT6i non-clinical data at ENA 2024 (October) Present palazestrant-ribociclib combo efficacy update File IND for OP-3136 KAT6i Initiate OP-3136 KAT6i Pha
Slide 11: Palazestrant
— Palazestrant OUR PHASE 3 ASSET “Palazestrant is not an endocrine therapy where you need to wait six months to see a patient begin to derive benefit. We’ve seen some not only nice responses, but pretty quick responses—significant reduction of disease burden. And you know, the patients feel great.”
Slide 12: Clinical development strategy to unlock the potential of palazestrant
Clinical development strategy to unlock the potential of palazestrant A best-in-class backbone therapy with the potential to preserve and prolong a higher quality of life Establishing palazestrant as the backbone endocrine therapy of choice across the metastatic setting 2/3L+ 1L Ongoing 510-patient
Slide 13: Palazestrant monotherapy Phase 2 data supports ongoing Phase 3 trial
Palazestrant monotherapy Phase 2 data supports ongoing Phase 3 trial Data demonstrate palazestrant is well-tolerated with favorable PK and differentiated efficacy profile For more details on this data milestone, please refer to the oral presentation at this link. CT = chemotherapy; ESR1 = estrogen r
Slide 14: Palazestrant Phase 2 data supports ongoing Phase 3 trial
Compelling palazestrant Phase 2 data supports ongoing Phase 3 trial 7.3 months mPFS in ESR1-mutant; 5.5 months in wild-type for EMERALD-eligible 2/3L ± CT Patients* * NOTE: This analysis is the aggregation of results across independent studies. There are risks inherent in conducting cross-trial comp
Slide 15: OPERA-01 Phase 3 monotherapy trial designed to show safety/efficacy
OPERA-01 Phase 3 monotherapy trial designed to show safety/efficacy 510-patient Phase 3 2/3L monotherapy trial vs. standard of care For more details on this trial, please visit www.opera01study.com. CDK4/6i = cyclin dependent kinase 4/6 inhibitor; ESR1 = estrogen receptor 1 gene; SOC = standard of c
Slide 16: Physician quote: Nancy Lin, Dana-Farber Cancer Institute
— “Patients with metastatic breast cancer urgently await therapeutic advances that can be used effectively either as monotherapies or in combination with today’s standard of care to not only extend survival rates, but also deliver a better quality of life. With the body of evidence to date and our c
Slide 17: Palazestrant demonstrates combinability with other targeted agents
Palazestrant demonstrates combinability with other targeted agents Promising combinability for front-line use as well as in 2/3L setting CDK4/6i = cyclin dependent kinase 4/6 inhibitor; CBR = clinical benefit rate; CR = complete response; ER+ = estrogen receptor positive; HER2- = human epidermal gro
Slide 18: Combination therapy: palazestrant-ribociclib treatment-emergent AEs
Combination therapy: palazestrant-ribociclib treatment-emergent AEs Well tolerated with no DLTs; safety and tolerability profile consistent to ribociclib + ET * NOTE: This analysis is the aggregation of results across independent studies. There are risks inherent in conducting cross-trial comparison
Slide 19: Combination therapy: efficacy comparison in 2/3L+ patients
Combination therapy: efficacy comparison in 2/3L+ patients MAINTAIN study of ribociclib after CDK4/6i progression serves as clinical benchmark* Benchmark Clinical Benefit Rate*^ in CDK4/6i pre-treated patients Palazestrant + ribociclib combination showed efficacy in ESR1-mut and wild-type patients 8
Slide 20: Proposed OPERA-02 Phase 3 pivotal trial in combination with ribociclib
Proposed OPERA-02 Phase 3 pivotal trial in combination with ribociclib ~1,000-patient trial vs. standard of care in planning for 2025 initiation CDK4/6 = cyclin dependent kinase 4/6; CBR = clinical benefit rate; DOR = duration of response; ER+ = estrogen receptor positive; HER2- = human epidermal gr
Slide 21: Building momentum for palazestrant as a potential backbone therapy
Building momentum for palazestrant as a potential backbone therapy Registration-directed pivotal Phase 3 clinical trials underway and planned 510-patient 2/3L Phase 3 monotherapy trial vs. standard of care Currently enrolling Visit opera01study.com for more information ~1,000-patient 1L Phase 3 comb
Slide 22: Planning for palazestrant U.S. commercial launch in 2027
Planning for palazestrant U.S. commercial launch in 2027 Initial launch anticipated in 2/3L setting with potential 1L launch following positive OPERA-02 trial Annual U.S. incidence estimated at ~40K patients Commercial launch planning beginning in 2025 Early commercial leadership build in 2026 Estab
Slide 23: KAT6 Inhibitor (OP-3136)
— KAT6 Inhibitor (OP-3136)
Slide 24: OP-3136: Olema's KAT6 inhibitor
OP-3136: Olema’s KAT6 inhibitor* An exciting new and validated target for ER+/HER2- metastatic breast cancer Highly potent and selective against KAT6A/B Orally bioavailable with high levels of free drug exposure OP-3136 synergizes with palazestrant and CDK4/6 inhibitors in preclinical models New dat
Slide 25: KAT6 inhibitor mechanism of action
KAT6 inhibitor mechanism of action KAT6 is a clinically validated target1 and overexpression correlated with worse clinical outcomes in ER+ breast cancer2 KAT6 inhibition downregulates genes involved in estrogen receptor signaling and other signaling pathways3 Inhibition regulated gene expression th
Slide 26: Pfizer's KAT6i data demonstrate potential in metastatic breast cancer
Pfizer’s KAT6i data demonstrate potential in metastatic breast cancer ET = endocrine therapy; KAT6i = lysine acetyltransferase 6 inhibitor; PFS = progression free survival. 1 Mukohara T, et al. Inhibition of lysine acetyltransferase KAT6 in ER+ HER2- metastatic breast cancer: a phase 1 trial. Nat Me
Slide 27: OP-3136 preclinical data demonstrates specificity for KAT6A/B
OP-3136 – preclinical data demonstrates specificity for KAT6A/B CDK4/6i = cyclin dependent kinase 4/6 inhibitor; KAT6i = lysine acetyltransferase 6 inhibitor Note: Olema KAT6 inhibitors discovered in collaboration with Aurigene 1 Mukohara T, et al. Inhibition of lysine acetyltransferase KAT6 in ER+
Slide 28: OP-3136 demonstrates anti-tumor activity in xenograft models
OP-3136 demonstrates anti-tumor activity in xenograft models Dose-dependent tumor growth inhibition and regression at lower doses compared to PF-8144 4 8 24 100 1000 Day of dosing mm3 Mean Tumor Volume 400 700 12 16 20 0 100 300 400 800 mm3 Day 25: Tumor Volume Vehicle OP-3136 - 0.1 mg/kg OP-3136 -
Slide 29: Olema: a 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 Cash position as of June 30, 2024, includes the Company’s cash, cash equivalents, and marketable securities. Palazestrant anchors Olema’s breast cancer program as a p
Slide 30: Advancing medicines for breast cancer and beyond
— Advancing medicines for breast cancer and beyond
Olema Pharmaceuticals — Investor Presentation (September 2024) on 6ix