Olema Pharmaceuticals(OLMA) - 2022 Q1 - Quarterly Report

Financial Position - As of March 31, 2022, the company had cash, cash equivalents, and marketable securities totaling $267.9 million, expected to fund operations into 2024[102] - The accumulated deficit as of March 31, 2022, was $127.2 million, with no debt outstanding[132] Operating Losses - The company reported net losses of $23.0 million for the three months ended March 31, 2022, compared to $15.3 million for the same period in 2021, with an accumulated deficit of $127.2 million[103] - The company expects to incur significant operating losses for the foreseeable future as it advances its product candidates[104] - The net loss for Q1 2022 was $23.0 million, compared to a net loss of $15.3 million in Q1 2021, indicating an increase in losses of 50.5%[127] Research and Development Expenses - Research and development expenses for the lead product candidate OP-1250 were $16.0 million for the three months ended March 31, 2022, up from $10.7 million in the same period of 2021[119] - Research and development expenses for Q1 2022 were $16.0 million, up from $10.7 million in Q1 2021, representing a 49.7% increase[128] - The increase in research and development expenses was primarily due to advancing the clinical study for OP-1250 and associated contract manufacturing costs[128] - The company expects significant increases in both research and development and general and administrative expenses as it advances its product candidates and expands operations[133] Revenue Generation - The company has not generated any revenue from product sales and does not expect to do so for the foreseeable future[113] - The company has not generated any revenue from product sales to date and does not expect to do so until regulatory approval is obtained[135] Funding Requirements - The company anticipates requiring substantial additional funding to support ongoing operations and product development[107] - The company anticipates needing additional capital to fund ongoing operations and development efforts, with future funding requirements dependent on various factors including clinical trial outcomes[135] Cash Flow - Net cash used in operating activities for Q1 2022 was $17.9 million, compared to $11.1 million in Q1 2021, marking a 61.5% increase[142] - Net cash provided by financing activities for the three months ended March 31, 2022, was less than $0.1 million from the exercise of stock options[146] - There were no financing activities during the three months ended March 31, 2021[147] Clinical Trials - The ongoing Phase 1/2 trial for OP-1250 is evaluating its effectiveness in treating ER+/HER2- breast cancer, with initial data reported in November 2021[97] - The company is actively monitoring the impact of the COVID-19 pandemic on its operations and clinical trials[108] Manufacturing and Operations - The company relies on third parties for manufacturing and does not own any manufacturing facilities[101] Commitments and Contingencies - No significant changes to commitments and contingencies were reported during the three months ended March 31, 2022[148] - There are currently no off-balance sheet arrangements as defined by SEC regulations[149] Accounting Policies - No material changes to critical accounting policies were reported for the three months ended March 31, 2022[151] - There were no material changes to market risk disclosures during the three months ended March 31, 2022[152]