Olema Pharmaceuticals(OLMA) - 2022 Q2 - Quarterly Report

Financial Position - As of June 30, 2022, the company had cash, cash equivalents, and marketable securities totaling $240.7 million, expected to fund operations into the second half of 2024[106]. - The accumulated deficit as of June 30, 2022, was $160.1 million, with no debt outstanding[139]. - The company anticipates needing additional capital to fund operations, which may come from equity or debt financings, collaborations, or licensing arrangements[142]. Financial Performance - The company reported net losses of $32.9 million for Q2 2022, compared to $16.4 million for Q2 2021, and $55.9 million for the first half of 2022, compared to $31.7 million for the same period in 2021[107]. - The net loss for Q2 2022 was $32.9 million, compared to a net loss of $16.4 million in Q2 2021, reflecting an increase of 100%[138]. - The company expects to incur significant expenses and operating losses for the foreseeable future as it advances the development of OP-1250[140]. Research and Development - Research and development expenses for Q2 2022 were $27.1 million, up from $11.9 million in Q2 2021, and $43.1 million for the first half of 2022, compared to $22.6 million for the same period in 2021[121]. - Research and development expenses for the first half of 2022 were $43.1 million, up from $22.6 million in the first half of 2021, an increase of 91%[135]. - The ongoing Phase 1/2 trial for the lead product candidate OP-1250 is evaluating its efficacy in treating ER+/HER2- breast cancer, with initial data expected in Q4 2022[101]. Operating Expenses - General and administrative expenses for Q2 2022 were $6.2 million, compared to $4.6 million in Q2 2021, an increase of 35%[131]. - General and administrative expenses for the first half of 2022 were $13.5 million, compared to $9.4 million in the first half of 2021, an increase of 44%[136]. - Total operating expenses for Q2 2022 were $33.3 million, a 101% increase from $16.5 million in Q2 2021[129]. Cash Flow - Net cash used in operating activities for the six months ended June 30, 2022 was $55.9 million, with a net loss primarily due to $43.1 million in research and development expenses and $13.5 million in general and administrative expenses[151]. - For the six months ended June 30, 2021, net cash used in operating activities was $31.7 million, with $22.6 million in research and development expenses and $9.4 million in general and administrative expenses[152]. - Net cash provided by financing activities during the six months ended June 30, 2022 was $0.1 million from the sale of common stock under the 2020 ESPP and exercise of stock options[157]. Manufacturing and Operations - The company plans to scale up external manufacturing capacity and establish a sales and marketing infrastructure for potential commercialization[113]. - The company relies on third parties for manufacturing and does not plan to establish its own manufacturing facilities[105]. - The COVID-19 pandemic has caused delays in clinical trial setup and recruitment, impacting development timelines[112]. Accounting and Risk - There were no material changes to critical accounting policies and estimates during the six months ended June 30, 2022[159]. - The company’s management evaluates estimates and assumptions on an ongoing basis, which may differ from actual results under different conditions[158]. - No material changes to market risk disclosures were reported for the six months ended June 30, 2022[160].