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Olema Pharmaceuticals(OLMA) - 2021 Q2 - Quarterly Report

Financial Position - As of June 30, 2021, the company had cash, cash equivalents, and marketable securities totaling $318.1 million, expected to fund operations through the end of 2023[109]. - As of June 30, 2021, the company had $318.1 million in cash, cash equivalents, and marketable securities[144]. - The company anticipates that its existing cash and marketable securities will fund operations through the end of 2023, after which substantial additional funding will be needed[148]. Losses and Expenses - The company reported net losses of $16.4 million for Q2 2021, compared to $2.5 million for Q2 2020, and an accumulated deficit of $64.8 million as of June 30, 2021[110]. - Net loss for the six months ended June 30, 2021 was $31.7 million, compared to a net loss of $4.1 million for the same period in 2020[142]. - The company expects to incur significant expenses and operating losses for the foreseeable future as it advances the nonclinical and clinical development of its lead product candidate OP-1250[145]. - General and administrative expenses for the three months ended June 30, 2021 were $4.6 million, up $4.1 million from $0.5 million in the same period in 2020[136]. - Total operating expenses for the six months ended June 30, 2021 were $31.97 million, an increase of $28.44 million compared to the same period in 2020[138]. - Net cash used in operating activities for the six months ended June 30, 2021 was $19.99 million, compared to $3.32 million for the same period in 2020[154]. Research and Development - Research and development expenses for Q2 2021 were $11.9 million, significantly up from $1.9 million in Q2 2020, and totaled $22.6 million for the first half of 2021 compared to $2.7 million in the same period of 2020[124]. - The increase in research and development expenses for the six months ended June 30, 2021 was primarily due to advancing the OP-1250 clinical study and associated costs[139]. - The company anticipates significant increases in research and development expenses as it advances OP-1250 and other potential product candidates through clinical trials[111]. - The ongoing Phase 1/2 trial for OP-1250, targeting ER+ breast cancer, was initiated in August 2020, with initial data expected in Q4 2021[105]. - The company aims to expand its clinical product pipeline and may pursue additional product candidates in the future[111]. Revenue Generation - The company has not generated any revenue from product sales and does not expect to do so for the foreseeable future[120]. - The company has not generated any revenue from product sales and does not expect to do so until regulatory approval is obtained for its product candidates[147]. Funding and Financing - The company expects to incur substantial additional funding needs to support product development and operations, potentially through equity or debt financing[114]. - Net cash provided by financing activities for the six months ended June 30, 2021 included $0.4 million from the sale of common stock under the 2020 ESPP and $0.1 million from stock options exercise[161]. - Net cash provided by financing activities for the six months ended June 30, 2020 was $50.7 million from the sale and issuance of Series B convertible preferred stock and $3.0 million from convertible promissory notes[162]. Operational Challenges - The COVID-19 pandemic has caused delays in clinical trial setup and site initiation, impacting recruitment and timelines[115]. - The company relies on third parties for manufacturing and does not plan to establish its own manufacturing facilities[108]. Other Financial Information - Net cash used in investing activities for the six months ended June 30, 2021 was mainly for purchases of marketable securities, financed through IPO proceeds and convertible preferred stock sales[160]. - There were no significant changes to contractual obligations and commitments during the six months ended June 30, 2021[163]. - The company did not have any off-balance sheet arrangements during the periods presented[164]. - There were no material changes to critical accounting policies during the six months ended June 30, 2021[166]. - No material changes to market risk disclosures were reported for the six months ended June 30, 2021[167].