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Olema CONCOLOGY Olema Oncology Reports Third Quarter 2021 Financial Results and Provides Corporate Update November 10 , 2021 • Completed dose - escalation stage of Phase 1/2 clinical trial of OP - 1250 in patients with metastatic , ER + / HER2 - breast cancer • Interim safety , tolerability , pharmacokinetic and initial efficacy data from Phase 1 dose escalation to be presented at 2021 San Antonio Breast Cancer Symposium • Phase 1b dose expansion to initiate by year - end 2021 ; Phase 2 to initiate in Q1 2022 • First planned clinical study in combination with CDK4 / 6 inhibitor to initiate in Q1 2022 SAN FRANCISCO , Nov. 10 , 2021 ( GLOBE NEWSWIRE ) -- Olema Pharmaceuticals , Inc. ( “ Olema ” or “ Olema Oncology , " Nasdaq : OLMA ) , a clinical - stage biopharmaceutical company focused on the discovery , development and commercialization of targeted therapies for women's cancers , today provided an update on recent company developments and reported third quarter financial results for the period ended September 30 , 2021 . " Our team has made great progress advancing OP - 1250 through the dose escalation portion of our ongoing Phase 1/2 clinical trial and we look forward to presenting interim pharmacokinetic , safety , tolerability and initial efficacy data at the San Antonio Breast Cancer Symposium in December , " said Sean P. Bohen , M.D. , Ph.D. , President and Chief Executive Officer of Olema Oncology . " We are encouraged by the emerging clinical profile of OP - 1250 and plan to initiate Phase 2 monotherapy expansion as well as the first planned Phase 1b combination trial with a CDK4 / 6 inhibitor in the first quarter of 2022. " " OP - 1250 has the potential to be a differentiated , best - in - class complete estrogen receptor ( ER ) antagonist ( CERAN ) that we believe could become the backbone endocrine therapy of choice for ER + breast cancer . As we enroll more patients , we look forward to generating additional clinical data in support of OP - 1250's use both as monotherapy and in combination with other approved breast cancer treatments , " continued Dr. Bohen . Recent Corporate Highlights • Completed dose escalation in the ongoing Phase 1/2 study of OP - 1250 in patients with metastatic , ER + / HER2- breast cancer . • Selected the OP - 1250 starting dose and initiated preparations for the first planned combination study with a CDK4 / 6 inhibitor . • Presented new nonclinical data on OP - 1250 at the 1st JCA - AACR Precision Cancer Medicine International Conference held virtually from September 10-12 , 2021 ( U.S. ) and September 11-12 , 2021 ( Japan ) . The poster presentation reviewed a series of nonclinical assessments Olema conducted on a panel of antiestrogens with known chemical structures to evaluate their ability to inhibit ER activity , block breast cancer proliferation and degrade ER receptors . • Presented a Trials - in - Progress poster at the AACR - NCI - EORTC International Conference on Molecular Targets and Cancer Therapeutics , held virtually from October 7-10 , 2021. The poster reviewed the design of Olema's ongoing Phase 1/2 open - label , first - in - human , multicenter , dose - escalation and dose - expansion study evaluating OP - 1250 monotherapy in adult subjects with recurrent , locally advanced or metastatic ER + / HER2- breast cancer ( NCT04505826 ) . • Expanded Olema's operational footprint with the opening of new office space in Cambridge , Massachusetts . Anticipated Milestones • Present interim Phase 1 monotherapy dose escalation data at the 2021 San Antonio Breast Cancer Symposium . • Initiate dose expansion by year - end with up to two doses . Each cohort will enroll approximately 15 patients with measurable disease , and findings will help inform the selection of a recommended Phase 2 dose ( RP2D ) . • Initiate Phase 2 in the first quarter of 2022. Preliminary anti - tumor efficacy will be assessed across three cohorts : patients with measurable disease ( N = 50 ) , patients with non - measurable disease ( N = 15 ) and patients with CNS metastasis ( N = 15 ) . • Initiate the first Phase 1b clinical trial of OP - 1250 in combination with a CDK4 / 6 inhibitor in the first quarter of 2022 . Financial Highlights • Cash , cash equivalents and marketable securities as of September 30 , 2021 were $ 306.0 million . Olema anticipates that this balance of cash will be sufficient to fund operations through the end of 2023 .