Earnings release
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Olema CONCOLOGY Olema Oncology Reports Second Quarter 2021 Financial Results and Provides Corporate Update August 10 , 2021 • Presentation of preliminary Phase 1/2 dose - escalation data for OP - 1250 in patients with metastatic , ER + / HER2 - breast cancer planned for Q4 2021 • Strong cash , cash equivalents and marketable securities position of $ 318.1 million as of June 30 , 2021 sufficient to support execution of clinical , research and operational goals through the end of 2023 SAN FRANCISCO , Aug. 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 second quarter financial results for the period ended June 30 , 2021 . " We made important progress in the second quarter of 2021 as we advanced the clinical development of our lead candidate , OP - 1250 , an investigational complete estrogen receptor ( ER ) antagonist ( CERAN ) , and strengthened our corporate foundation to ensure that we have the talent and resources in place to support our future success , " said Sean P. Bohen , M.D. , Ph.D. , President and Chief Executive Officer of Olema Oncology . " We have seen robust enrollment in the ongoing Phase 1/2 clinical trial of OP - 1250 and look forward to sharing interim dose - escalation data at a medical meeting in the fourth quarter of this year . " Corporate Highlights and Anticipated Milestones • Significant progress advancing the Phase 1/2 clinical trial of OP - 1250 in patients with metastatic , ER + / HER2 - breast cancer . As of June 4 , 2021 , 28 patients have been enrolled across five dose - escalation cohorts . OP - 1250 has demonstrated oral bioavailability and a dose - proportional pharmacokinetic profile consistent with predictions from Olema nonclinical models . A maximum tolerated dose has not been identified . The Company plans to present interim safety , tolerability , pharmacokinetic and initial efficacy data at a medical meeting in the fourth quarter of 2021 , pending abstract acceptance . • Advance into monotherapy dose expansion in the second half of 2021 . • Initiate a Phase 1b clinical trial of OP - 1250 in combination with a CDK4 / 6 inhibitor in the first quarter of 2022 . Second Quarter 2021 Financial Highlights • Cash , cash equivalents and marketable securities as of June 30 , 2021 were $ 318.1 million . Olema anticipates that this cash balance will be sufficient to fund operations through the end of 2023 . • Research and development ( R & D ) expenses were $ 11.9 million for the quarter ended June 30 , 2021 , compared to $ 1.9 million for the same period of the prior year . The increase in R & D expenses was primarily due to increased expenditures to advance the Phase 1/2 clinical trial of OP - 1250 , the increase in nonclinical development activities , higher personnel - related expenses as headcount grew to support the advancement of the clinical and nonclinical programs , and higher non - cash stock - based compensation expenses . • General and administrative ( G & A ) expenses were $ 4.6 million for the quarter ended June 30 , 2021 , compared to $ 0.5 million for the same period of the prior year . The increase in G & A expenses was primarily due to higher personnel - related expenses associated with increases in the number of G & A personnel supporting the growth of the organization , public company - related expenses and other corporate costs , and non - cash share - based compensation expenses . • Net loss for the quarter ended June 30 , 2021 was $ 16.4 million , compared to $ 2.5 million for the same period of the prior year . About Olema Oncology Olema Oncology is a clinical - stage biopharmaceutical company focused on the discovery , development and commercialization of targeted therapies for women's cancers . Olema's lead product candidate , OP - 1250 , is an orally - available small molecule with combined activity as both a complete estrogen receptor ( ER ) antagonist ( CERAN ) and a selective ER degrader ( SERD ) . It is currently being evaluated as a single agent in an ongoing Phase 1/2 clinical trial in patients with recurrent , locally advanced or metastatic ER - positive ( ER + ) , human epidermal growth factor receptor 2 - negative ( HER2- ) breast cancer . Olema is headquartered in San Francisco .