Olema Pharmaceuticals(US:OLMA)2022-02-28 21:56Financial Performance - The company has incurred net losses of $71.1 million, $22.1 million, and $4.3 million for the years ended December 31, 2021, 2020, and 2019, respectively, with an accumulated deficit of $104.2 million as of December 31, 2021[634]. - The net loss for the year ended December 31, 2021, was $71.1 million, compared to a net loss of $22.1 million in 2020, representing an increase of $48.9 million[653]. - Net loss attributable to common stockholders rose from $23,990,000 in 2020 to $71,096,000 in 2021, an increase of approximately 195%[715]. - The company expects to incur significant expenses and operating losses in the foreseeable future as it advances the development of OP-1250 and other programs[662]. - The company reported a net unrealized loss on marketable securities of $149,000 in 2021[715]. - Total comprehensive loss for 2021 was $71,245,000 compared to $22,121,000 in 2020, reflecting a significant increase[715]. Cash and Funding - The company had $287.3 million in cash, cash equivalents, and marketable securities as of December 31, 2021, which is expected to fund operations into 2024[633]. - The company anticipates significant additional funding will be required to support ongoing operations and product development efforts[638]. - The company has raised a total of $392.7 million from various financing activities since inception, including an initial public offering that generated approximately $220.6 million in net proceeds[631]. - The company expects its existing cash and marketable securities will fund operations into 2024, after which substantial additional funding will be required[665]. - The company reported a net cash decrease of $324.7 million for the year ended December 31, 2021, compared to an increase of $338.5 million in 2020[674]. Research and Development - Research and development expenses for the lead product candidate OP-1250 were $51.1 million, $13.7 million, and $3.9 million for the years ended December 31, 2021, 2020, and 2019, respectively[645]. - The ongoing Phase 1/2 clinical trial for OP-1250 was initiated in August 2020, with initial data reported in November 2021, demonstrating proof-of-concept for the treatment of ER+/HER2- breast cancer[628]. - The company plans to continue increasing research and development expenses as it advances OP-1250 and other potential product candidates through clinical trials[646]. - Research and development expenses surged from $13,704,000 in 2020 to $51,100,000 in 2021, marking an increase of about 273%[715]. - Research and development costs are expensed as incurred, including personnel expenses, stock-based compensation, and external costs related to clinical trials[745]. Operating Expenses - Total operating expenses for the year ended December 31, 2021, reached $71.5 million, compared to $21.5 million in 2020, reflecting a $49.9 million increase[653]. - General and administrative expenses for the year ended December 31, 2021, were $20.4 million, up $12.6 million from $7.8 million in 2020, driven by higher headcount and public company-related expenses[655]. - Total operating expenses increased significantly from $21,528,000 in 2020 to $71,491,000 in 2021, representing a growth of about 232%[715]. Clinical Collaborations - The Company entered into a clinical collaboration and supply agreement with Novartis to evaluate OP-1250 in combination with Novartis' drugs, focusing on metastatic estrogen receptor-positive breast cancer[807]. - A non-exclusive clinical trial agreement was established with Pfizer to evaluate OP-1250 in combination with IBRANCE® for patients with recurrent, locally advanced or metastatic ER+, HER2- breast cancer[812]. - Costs incurred under the Novartis and Pfizer agreements were not material to the consolidated financial statements for the years ended December 31, 2021, and 2020[811][815]. Assets and Liabilities - As of December 31, 2021, total financial assets amounted to $287.25 million, with cash and cash equivalents at $13.81 million and short-term marketable securities at $260.62 million[768]. - Total assets decreased from $342,722,000 in 2020 to $295,945,000 in 2021, a decline of approximately 13.6%[714]. - Other current liabilities rose significantly to $8.07 million in 2021, up from $3.87 million in 2020, driven by increased accrued R&D costs and employee bonuses[774]. Stock and Compensation - The total stock-based compensation expense for the year ended December 31, 2021, was $15.9 million, a significant increase from $3.1 million in 2020[789]. - The weighted-average grant-date fair value per share of options granted in 2021 was $21.87, with a total fair value of options vested during the year amounting to $10.9 million[785]. - The Company had 5,768,028 stock options outstanding as of December 31, 2021, with a weighted average exercise price of $15.99[783]. - The Company had 493,185 unvested restricted common stock shares as of December 31, 2021, down from 735,294 shares in 2020[798]. Regulatory and Market Risks - The company is subject to various risks, including the uncertainty of clinical trial results and regulatory approvals, which could materially affect future operating results[736]. - The impact of the COVID-19 pandemic has caused delays in clinical trial setup and recruitment, but the overall business operations were not materially adversely affected in 2021[639]. - Olema's operations were not materially adversely affected by the COVID-19 pandemic in 2021, although the situation remains uncertain[726].