Improving the lives of women with breast cancer

November 2022

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 forward-looking statements include, without limitation, statements regarding our research and clinical development plans, the scope, progress, results and costs of developing our product candidate or any other future product candidates, expected manufacturing capabilities, strategy, regulatory matters, including the timing and likelihood of success of obtaining drug approvals, market size and opportunity and our ability to complete certain milestones. Words such as "believe," "anticipate," "plan," "expect," "intend," "will," "may," "goal," "project," "estimate," "potential" and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based on the beliefs of the Company's management as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about the Company, including, without limitation, risks inherent in developing products and technologies, future results from the Company's ongoing and planned clinical trials, the Company's ability to obtain adequate financing to fund its planned clinical trials and other expenses, trends in the industry, the legal and regulatory framework for the industry and future expenditures, and other risks and uncertainties affecting Olema, including those described under the caption "Risk Factors" and elsewhere in Olema's quarterly report on Form 10-Q filed on November 8, 2022, and future filings and reports of Olema with the Securities and Exchange Commission. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The actual results may vary from the anticipated results and the variations may be material. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated in this presentation. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this presentation is given.

This presentation discusses product candidates that are under clinical study and which have not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied.

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Aspire to Improve Outcomes for Women Living with Breast Cancer

Lead Program, OP-1250*, is an Oral, Small Molecule Complete Estrogen Receptor Antagonist (CERAN)

Designed to completely shut-down estrogen pathways in women with ER+/HER- metastatic breast cancer. 1st indication, for 2L/3L+ therapy, could represent a $3-5B U.S. segment of $20B endocrine therapy market

Successful monotherapy studies have shown robust single-agent activity, encouraging safety and tolerability; Preparing for Phase 3 monotherapy initiation in mid-2023

Combination studies ongoing with Ibrance®, Kisquali® and Piqray®

Internally-discovered, based on Olema nuclear receptor expertise

Received Fast Track designation from U.S. FDA in July 2022

Strong balance sheet with $222.6M** cash position;

Sufficient capital to fund clinical and development operations into 2H 2024

OLMA

*OP-1250 is an investigational compound and not currently approved by FDA. Safety and efficacy have not been established.

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**Cash, cash equivalents and marketable securities as of September 30, 2022

Highly Encouraging Preliminary Phase 1/2 Clinical Results

  • Over 125 patients treated to date with OP-1250
    • Data presented at ENA 2022* across 68 patients at doses of 60 mg and 120 mg
  • OP-1250is well tolerated with attractive PK, high drug exposures and strong anti-tumor activity
    • Majority of TRAEs are grade 1 / 2 in nature
  • Efficacy continues to mature with durable benefit demonstrated with 4 cPRs and 2 uPRs
    • 41% of patients demonstrating reduction in target lesions despite significant # of patients expected to be endocrine therapy resistant
    • 39% CBR at RP2D of 120 mg
    • Activity in both wild-type and ESR1 mutant tumors
  • Recommended Phase 2 dose of 120 mg chosen based upon PK, tolerability and efficacy
    • Phase 2 monotherapy study rapidly advancing with primary cohorts fully enrolled
    • Phase 3 planning underway with study initiation planned for mid-2023
  • Demonstrated combinability with CDK 4/6 inhibitors
    • Currently in Phase 2 expansion in combination with palbociclib at OP-1250's RP2D of 120 mg
    • Phase 1b dose escalation with ribociclib and alpelisib ongoing

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* Data-cut as of Sept 2, 2022.

Rapidly Advancing OP-1250 into Pivotal Studies Beginning in 2023

OP-1250

Evaluating OP-1250 across a range of ER cohorts in monotherapy and combination trials

Preclinical

Phase I

Phase II

Phase III

Clinical Collaboration

ER+/HER2- Metastatic Breast Cancer

2/3 Line Monotherapy

(with and without CNS metastases)

Combo Therapy with CDK 4/6i palbociclib

Combo Therapy with CDK 4/6i ribociclib

Combo Therapy with PI3Ki alpelisib with

PIK3CA mutated

Combo Therapy with other agents

ER+/HER2+ Metastatic Breast Cancer with CNS METS

Combo Therapy with CNS metastases

Early Stage

Endometrial Cancer

Gynecologic malignancies

Novel Breast Cancer target

Undisclosed Oncology target

Programs

MBC = metastatic breast cancer; PI3Kα = phosphatidylinositol 3-kinase alpha; CDK4/6i = CDK4/6 inhibitor

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(1) Patient population may be studied as additional cohort(s) of current Phase 1/2 clinical trial or may be studied in a separate clinical trial.

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Olema Pharmaceuticals Inc. published this content on 09 November 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 November 2022 19:50:08 UTC.