SAN FRANCISCO, Feb. 28, 2022 (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 reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a business update.
“2021 was a transformative year for Olema. Our team made important progress against our strategic goals, culminating in the presentation of strong proof-of-concept data for OP-1250 in ER+ / HER2- breast cancer. The initial data, demonstrating OP-1250’s attractive pharmacokinetics, favorable tolerability and encouraging anti-tumor activity in a heavily pretreated patient population, validate OP-1250’s potential to become the endocrine therapy of choice for ER+ breast cancer. We are now actively expanding our clinical study enrollment and expect to be in a position to present more data later this year,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “Importantly, we entered 2022 with a strong balance sheet, and as we continue to build our team and grow our capabilities, we are well positioned to advance our clinical development program and discovery efforts.”
Recent Corporate Highlights
Anticipated Milestones
Fourth Quarter and Full Year 2021 Financial Results
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, and in Phase 1b combination with palbociclib, 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 and has operations in Cambridge, Massachusetts.
Non-GAAP Financial Information
The results presented in this press release include both GAAP information and non-GAAP information. As used in this release, non-GAAP research and development expense is defined by Olema as GAAP research and development expense excluding stock-based compensation expense, and non-GAAP general and administrative expense is defined by Olema as GAAP general and administrative expense excluding stock-based compensation expense. We use these non-GAAP financial measures to evaluate our ongoing operations and for internal planning and forecasting purposes. We believe that non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool, and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP. Other companies, including companies in our industry, may calculate similarly titled non-GAAP measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of our non-GAAP financial measures as tools for comparison. Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures and not rely on any single financial measure to evaluate our business.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “expect,” “intend,” “will,” “may,” “goal,” “estimate,” “potential” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the development of OP-1250, both as a monotherapy and in combination trials, including timelines related to data presentation, trial initiation and advancement, and enrollment, the beneficial characteristics, safety, efficacy and therapeutic effects of OP-1250, as well as the sufficiency of our financial resources and Olema being well positioned to advance its clinical development program and discovery efforts. Because such statements deal with future events and are based on Olema’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, the risk that Olema’s ongoing or future clinical studies in humans may show that OP-1250 is not a tolerable and effective treatment for breast cancer and other risks and uncertainties affecting Olema, as well as those discussed in the section titled “Risk Factors” in Olema’s Annual Report on Form 10-K for the year ended December 31, 2021 to be filed on February 28, 2022 and future filings and reports that Olema makes from time to time with the United States Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.
Olema Pharmaceuticals, Inc. | ||||
Condensed Consolidated Balance Sheets Data | ||||
(in thousands) | ||||
December 31, | December 31, | |||
2021 | 2020 | |||
(Audited) | (Audited) | |||
Cash, cash equivalents and marketable securities | $ | 287,250 | $ | 338,549 |
Total assets | $ | 295,945 | $ | 342,722 |
Total current liabilities | $ | 9,019 | $ | 4,585 |
Total liabilities | $ | 11,377 | $ | 4,585 |
Total stockholders’ equity | $ | 284,568 | $ | 338,137 |
Total liabilities and stockholders’ equity | $ | 295,945 | $ | 342,722 |
Olema Pharmaceuticals, Inc. | ||||||||||||||
Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||
(In thousands, except share and per share data) | ||||||||||||||
Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||
(Unaudited) | (Audited) | |||||||||||||
Operating expenses: | ||||||||||||||
Research and development (1) | $ | 15,975 | $ | 6,289 | $ | 51,100 | $ | 13,704 | ||||||
General and administrative (2) | 5,782 | 3,842 | 20,391 | 7,824 | ||||||||||
Total operating expenses | 21,757 | 10,131 | 71,491 | 21,528 | ||||||||||
Loss from operations | (21,757 | ) | (10,131 | ) | (71,491 | ) | (21,528 | ) | ||||||
Other income (expense): | ||||||||||||||
Interest income | 109 | - | 442 | 60 | ||||||||||
Interest expense | - | - | - | (653 | ) | |||||||||
Other income (expense) | 10 | - | (47 | ) | - | |||||||||
Total other income (expense), net | 119 | - | 395 | (593 | ) | |||||||||
Net loss | $ | (21,638 | ) | $ | (10,131 | ) | $ | (71,096 | ) | $ | (22,121 | ) | ||
Repurchase and retirement of Series A and Series A-1 convertible preferred stock | - | - | - | (1,869 | ) | |||||||||
Net loss attributable to common stockholders | $ | (21,638 | ) | $ | (10,131 | ) | $ | (71,096 | ) | $ | (23,990 | ) | ||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.54 | ) | $ | (0.50 | ) | $ | (1.80 | ) | $ | (3.42 | ) | ||
Weighted average shares used to compute net loss per share attributable to common stockholders, basic and diluted (3) | 39,742,723 | 20,155,342 | 39,524,272 | 7,021,468 | ||||||||||
Reconciliation of GAAP to Non-GAAP Information | ||||||||||||||
(In thousands) | ||||||||||||||
Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||
(Unaudited) | (Unaudited) | |||||||||||||
(1) Research and development reconciliation | ||||||||||||||
GAAP research and development | $ | 15,975 | $ | 6,289 | $ | 51,100 | $ | 13,704 | ||||||
Less: share-based compensation expense | 2,919 | 1,475 | - | 9,346 | 1,970 | |||||||||
Non-GAAP research and development | $ | 13,056 | $ | 4,814 | $ | - | $ | 41,754 | $ | 11,734 | ||||
(2) General and administrative reconciliation | ||||||||||||||
GAAP general and administrative | $ | 5,782 | $ | 3,842 | $ | - | $ | 20,391 | $ | 7,824 | ||||
Less: share-based compensation expense | 1,708 | 867 | - | 6,567 | 1,108 | |||||||||
Non-GAAP general and administravie | $ | 4,074 | $ | 2,975 | $ | - | $ | 13,824 | $ | 6,716 | ||||
(3) The weighted average shares used to compute net loss attributable to common stockholders include the weighted average effects of the conversion of all outstanding convertible preferred stock into 23,765,065 shares of common stock of the company and the sale of 12,650,000 common shares in connection with the company's November 2020 initial public offering. |
Contact: Eva Stroynowski Vice President, Communications and Investor Relations [email protected]
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