Olema Pharmaceuticals, Inc. · NASDAQ:OLMA
Olema Pharmaceuticals — Investor Presentation (January 2025)
34 slides from Olema Pharmaceuticals's investor presentation, Jan 13, 2025
Slide 1: Advancing medicines for breast cancer and beyond: Corporate Overview
Advancing medicines for breast cancer and beyond Corporate Overview January 2025 EXHIBIT 99.1
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 Olema is a leader in developing therapies for endocrine driven-cancers with a mechanistically superior scientific approach that fully inactivates estrogen receptor signaling Establish palazestrant as the best-in-class backbone
Slide 4: 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 Committee Ian Clark Chairman of the Board Sean Bohen, M.D., Ph.D. President and CEO Sandra Horning, M.D., FACP, FASCO Cindy Butitta Sco
Slide 5: Rapidly advancing clinical pipeline
Rapidly advancing clinical pipeline Actively accruing patients in palazestrant mono and combo trials as OP-3136 enters the clinic 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 everolim
Slide 6: 2024 achievements and anticipated milestones in 2025 and beyond
2025 2026 Advance patient accrual in the pivotal Phase 3 OPERA-01 clinical trial Initiate the pivotal Phase 3 OPERA-02 clinical trial of palazestrant in combination with ribociclib in 1L metastatic breast cancer Present new non-clinical data for OP-3136 Present mature Phase 1b/2 palazestrant + riboc
Slide 7: Our Phase 3 asset: 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.” – Virginia Borg
Slide 8: 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. who were diagnosed with breast cancer in 2024 ~42
Slide 9: 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. AI = aromatase in
Slide 10: Palazestrant has the attributes of a potential therapeutic class leader
Palazestrant has the attributes of a potential therapeutic class leader A differentiated oral CERAN/SERD targeting metastatic breast cancer with experience in over 400 patients to date Complete ER antagonism Once-daily oral delivery Favorable tolerability Combinability Robust tumor shrinkage Attract
Slide 11: 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 12: Clinical development strategy to unlock the potential of palazestrant
Clinical development strategy to unlock the potential of palazestrant Potential best-in-class backbone therapy designed 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 pi
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. Data cutoff date: July 7, 2023 AEs =
Slide 14: Compelling palazestrant Phase 2 data supports ongoing OPERA-01 trial
Compelling palazestrant Phase 2 data supports ongoing OPERA-01 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 com
Slide 15: Palazestrant in the competitive landscape: best-in-class potential
Palazestrant in the competitive landscape: best-in-class potential Median progression-free survival across 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
Slide 16: OPERA-01 Phase 3 monotherapy trial design
OPERA-01 Phase 3 monotherapy trial designed to show superior efficacy in ESR1 mutant and/or ESR1 wild-type patients For more details on this trial, please visit www.opera01study.com. BIRC = blinded independent review committee; CBR = clinical benefit rate; CDK4/6i = cyclin dependent kinase 4/6 inhib
Slide 17: Palazestrant demonstrates combinability with other targeted agents
Palazestrant demonstrates combinability with other targeted agents in frontline and later lines of therapy CDK4/6i = cyclin dependent kinase 4/6 inhibitor; CBR = clinical benefit rate; CR = complete response; ER+ = estrogen receptor positive; HER2- = human epidermal growth factor receptor 2 negative
Slide 18: Palazestrant + ribociclib Phase 1b/2 data supports planned Phase 3 trial
Palazestrant + ribociclib Phase 2 data supports planned Phase 3 trial Palazestrant + ribociclib combination demonstrated promising clinical activity, a safety profile consistent with ribociclib + ET, and favorable tolerability Data cutoff date: November 11, 2024 AEs = adverse events; AI = aromatase
Slide 19: 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 20: 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 21: 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 22: 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 23: 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; initiation expected in 2025 Study Endpoints Primary: PFS (BIRC) Secondary : OS (key) PFS (Investigator) ORR/CBR/DOR (BIRC, Investigator) Safety PK Health-related PROs n ≈ 1,000 Palaze
Slide 24: 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 25: 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 Esta
Slide 26: OP-3136 Potential Best-in-Class KAT6 Inhibitor
— OP-3136 Potential Best-in-Class KAT6 Inhibitor “Building on our earlier studies that showed compelling single agent activity for OP-3136, this new data demonstrates the potential for OP-3136 in combination with palazestrant, with strong tumor growth inhibition and regression relative to combinatio
Slide 27: OP-3136: Olema's KAT6 inhibitor
OP-3136: Olema’s KAT6 inhibitor* An exciting new and validated target^ for the treatment of 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 preclini
Slide 28: OP-3136 mechanism of action
OP-3136 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 through b
Slide 29: KAT6i validated as an active new target in metastatic breast cancer
KAT6i validated as an active new target in metastatic breast cancer* * NOTE: Incorporates publicly-available third-party data that we have not independently verified. These results should be interpreted with caution. Such third-party data has been pulled by us from publicly-available sources for sup
Slide 30: OP-3136 demonstrates synergistic activity in combination with palazestrant
OP-3136 demonstrates synergistic activity in combination with palazestrant OP-3136 + palazestrant combinations appear superior to OP-3136+fulvestrant combinations Waterfall Plot (T47D CDX model) Palazestrant in combination with either OP-3136 or PF-8144 resulted in strong tumor regression relative t
Slide 31: OP-3136 Phase 1 study design
OP-3136 Phase 1 study design Primary objectives: Safety and tolerability, RDE (monotherapy + combination) Secondary objectives: PK, ORR (CR + PR), CBR (CR + PR + SD ≥24 weeks), DOR PART 1: DOSE ESCALATION DL1 DL2 DL3 DL4 Mono RDE ER+/HER2- mBC (or mCRPC or mNSCLC for PART 1A) Post-SOC (PART 1A) At l
Slide 32: A Compelling Late-Stage Opportunity in Breast Cancer and Beyond
— A Compelling Late-Stage Opportunity in Breast Cancer and Beyond Why Olema?
Slide 33: 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 Estimated cash, cash equivalents, and marketable securities as of December 31, 2024 (unaudited). CERAN = complete estrogen receptor antagonist; IND = investigational
Slide 34: Advancing medicines for breast cancer and beyond
— Advancing medicines for breast cancer and beyond
Olema Pharmaceuticals — Investor Presentation (January 2025) on 6ix