OLMA Olema Pharmaceuticals Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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OP-1250
HR+, HER2- Breast Cancer
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Phase 1
Phase 1
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Latest News
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- Interim pharmacokinetic, safety and tolerability, and preliminary efficacy data from Phase 1 dose escalation to be presented
- Company to host investor webcast at 8:30 a.m. ET on Wednesday, December 8, 2021
SAN FRANCISCO, Nov. 22, 2021 (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 announced two poster presentations on OP-1250, an investigational complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD) in development for the treatment of metastatic breast cancer and other women's cancers, at the upcoming San Antonio Breast Cancer Symposium (SABCS) meeting being held December 7-10, 2021, at the Henry B. Gonzalez Convention Center in San Antonio, Texas.
"We look forward to sharing the first clinical data for OP-1250, our investigational complete estrogen receptor antagonist (CERAN), at SABCS, one of the most important medical meetings of the year for scientific exchange on advancing care for breast cancer," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "These data, including pharmacokinetic, safety and tolerability, and preliminary efficacy, provide initial insights into the potential profile of OP-1250 in women living with advanced or metastatic ER+/HER2- breast cancer, an area where significant unmet need remains. We are encouraged by the emerging clinical profile of OP-1250, and believe it has the potential to become a differentiated, best-in-class endocrine therapy of choice for ER+ breast cancer."
Details of the poster presentations are as follows:
Title: Preliminary data from a phase I/II, multicenter, dose escalation study of OP-1250, an oral CERAN/SERD, in subjects with advanced and/or metastatic estrogen receptor (ER)-positive, HER2-negative breast cancer
- Presenter: Manish Patel, M.D., Florida Cancer Specialists/Sarah Cannon Research Institute
- Session: Poster Session 1 (P1-17-12)
- Session Title: Treatment - Advanced Disease Treatment: Advanced Endocrine Therapy
- Session Date: Wednesday, December 8, 2021; 7:00 a.m. CT
Title: The complete estrogen receptor antagonist OP-1250 can combine with HER2 inhibition to inhibit estrogen receptor-driven cellular proliferation and shrink xenograft tumors in ER+/HER2+ breast cancer models
- Presenter: Alison Parisian, Ph.D., Olema Oncology
- Session: Poster Session 5 (P5-08-07)
- Session Title: Tumor Cell and Molecular Biology: New Drugs and Mechanisms
- Session Date: Friday, December 10, 2021; 7:00 a.m. CT
Virtual posters will be made available on the SABCS virtual meeting platform at the start of their respective sessions. Abstracts for the posters can be found on the SABCS website here.
Conference Call and Webcast
Olema will host a conference call and webcast presentation for analysts and investors on Wednesday, December 8, 2021, at 8:30 a.m. ET (5:30 a.m. PT) to review the Phase 1 clinical data for OP-1250. The webcast player and accompanying slides may be accessed on the Investors section of Olema's website at www.olema.com. The conference call may be accessed by dialing +1 (833) 303-1210 for U.S. callers and +1 (918) 922-6526 for international callers and providing the passcode 7627078. A replay of the webcast will be available approximately two hours after the completion of the event and may be accessed by visiting Olema's website.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 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.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 and its potential as a treatment for breast cancer. 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 filed on November 10, 2021 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.Contact:
Eva Stroynowski
Vice President, Communications and Investor Relations
[email protected]
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- Completed dose-escalation stage of Phase 1/2 clinical trial of OP-1250 in patients with metastatic, ER+ / HER2- breast cancer
- Interim safety, tolerability, pharmacokinetic and initial efficacy data from Phase 1 dose escalation to be presented at 2021 San Antonio Breast Cancer Symposium
- Phase 1b dose expansion to initiate by year-end 2021; Phase 2 to initiate in Q1 2022
- First planned clinical study in combination with CDK4/6 inhibitor to initiate in Q1 2022
SAN FRANCISCO, Nov. 10, 2021 (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 provided an update on recent company developments and reported third quarter financial results for the period ended September 30, 2021.
"Our team has made great progress advancing OP-1250 through the dose escalation portion of our ongoing Phase 1/2 clinical trial and we look forward to presenting interim pharmacokinetic, safety, tolerability and initial efficacy data at the San Antonio Breast Cancer Symposium in December," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We are encouraged by the emerging clinical profile of OP-1250 and plan to initiate Phase 2 monotherapy expansion as well as the first planned Phase 1b combination trial with a CDK4/6 inhibitor in the first quarter of 2022."
"OP-1250 has the potential to be a differentiated, best-in-class complete estrogen receptor (ER) antagonist (CERAN) that we believe could become the backbone endocrine therapy of choice for ER+ breast cancer. As we enroll more patients, we look forward to generating additional clinical data in support of OP-1250's use both as monotherapy and in combination with other approved breast cancer treatments," continued Dr. Bohen.
Recent Corporate Highlights
- Completed dose escalation in the ongoing Phase 1/2 study of OP-1250 in patients with metastatic, ER+ / HER2- breast cancer.
- Selected the OP-1250 starting dose and initiated preparations for the first planned combination study with a CDK4/6 inhibitor.
- Presented new nonclinical data on OP-1250 at the 1st JCA-AACR Precision Cancer Medicine International Conference held virtually from September 10-12, 2021 (U.S.) and September 11-12, 2021 (Japan). The poster presentation reviewed a series of nonclinical assessments Olema conducted on a panel of antiestrogens with known chemical structures to evaluate their ability to inhibit ER activity, block breast cancer proliferation and degrade ER receptors.
- Presented a Trials-in-Progress poster at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, held virtually from October 7-10, 2021. The poster reviewed the design of Olema's ongoing Phase 1/2 open-label, first-in-human, multicenter, dose-escalation and dose-expansion study evaluating OP-1250 monotherapy in adult subjects with recurrent, locally advanced or metastatic ER+ / HER2- breast cancer (NCT04505826).
- Expanded Olema's operational footprint with the opening of new office space in Cambridge, Massachusetts.
Anticipated Milestones
- Present interim Phase 1 monotherapy dose escalation data at the 2021 San Antonio Breast Cancer Symposium.
- Initiate dose expansion by year-end with up to two doses. Each cohort will enroll approximately 15 patients with measurable disease, and findings will help inform the selection of a recommended Phase 2 dose (RP2D).
- Initiate Phase 2 in the first quarter of 2022. Preliminary anti-tumor efficacy will be assessed across three cohorts: patients with measurable disease (N=50), patients with non-measurable disease (N=15) and patients with CNS metastasis (N=15).
- Initiate the first Phase 1b clinical trial of OP-1250 in combination with a CDK4/6 inhibitor in the first quarter of 2022.
Financial Highlights
- Cash, cash equivalents and marketable securities as of September 30, 2021 were $306.0 million. Olema anticipates that this balance of cash will be sufficient to fund operations through the end of 2023.
- Net loss for the quarter ended September 30, 2021 was $17.7 million, compared to $7.8 million for the same period of the prior year.
- Research and development (R&D) expenses were $12.5 million for the quarter ended September 30, 2021, compared to $4.7 million for the same period of the prior year. The increase in R&D expenses was primarily related to the advancement of the ongoing Phase 1/2 clinical trial of OP-1250, increase in nonclinical development activities, higher personnel-related expenses and higher non-cash stock-based compensation expenses.
- General and administrative (G&A) expenses were $5.2 million for the quarter ended September 30, 2021, compared to $3.2 million for the same period of the prior year. The increase in G&A expenses was primarily related to an increase in personnel, public company-related expenses, other corporate costs and higher non-cash stock-based compensation expenses.
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 in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Olema is based in San Francisco and has operations in Cambridge, Massachusetts.
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, 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. 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 to be filed on November 10, 2021 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) September 30, December 31, 2021 2020 (Unaudited) (Audited) Cash, cash equivalents and marketable securities $ 305,954 $ 338,549 Total assets $ 309,795 $ 342,722 Total liabilities $ 8,901 $ 4,585 Total stockholders' equity $ 300,894 $ 338,137 Total liabilities and stockholders' equity $ 309,795 $ 342,722 Olema Pharmaceuticals, Inc. Condensed consolidated statements of operations and comprehensive loss (In thousands, except share and per share data) Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 (Unaudited) (Unaudited) Operating expenses: Research and development $ 12,523 $ 4,673 $ 35,125 $ 7,415 General and administrative 5,239 3,195 14,609 3,982 Total operating expenses (1) 17,762 7,868 49,734 11,397 Loss from operations (17,762 ) (7,868 ) (49,734 ) (11,397 ) Other (expense) income: Interest income 105 23 333 59 Interest expense - - - (653 ) Other income (expense) (56 ) 1 (57 ) 1 Total other income (expense), net 49 24 276 (593 ) Net loss $ (17,713 ) $ (7,844 ) $ (49,458 ) $ (11,990 ) Repurchase and retirement of Series A and Series A-1 convertible preferred stock - (1,869 ) - (1,869 ) Net loss attributable to common stockholders $ (17,713 ) $ (9,713 ) $ (49,458 ) $ (13,859 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.45 ) $ (3.71 ) $ (1.25 ) $ (5.29 ) Weighted average shares used to compute net loss per share attributable to common stockholders, basic and diluted 39,607,745 2,617,543 39,450,655 2,617,543 (1) Total operating expenses includes the following non-cash stock-based compensation expenses: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 (Unaudited) (Unaudited) Research and development $ 2,405 $ 392 $ 6,427 $ 495 General and administrative 1,752 190 4,859 241 $ 4,157 $ 582 $ 11,286 $ 736 Contact:
Eva Stroynowski
Vice President, Communications and Investor Relations
[email protected]
- Completed dose-escalation stage of Phase 1/2 clinical trial of OP-1250 in patients with metastatic, ER+ / HER2- breast cancer
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SAN FRANCISCO, Nov. 09, 2021 (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 announced that management will participate in two upcoming investor conferences in November.
Details for the company's participation are as follows:
- Event: Jefferies London Healthcare Conference
Date: Tuesday, November 16, 2021
Time: 5:00 p.m. GMT (12:00 p.m. ET / 9:00 a.m. PT)
Format: Live Fireside Chat - Event: 4th Annual Evercore ISI HealthCONx Conference
Date: Tuesday, November 30, 2021
Time: 11:45 a.m. ET (8:45 a.m. PT)
Format: Live Fireside Chat
Live webcasts of these presentations may be accessed under the Investors & Media section of Olema's website (www.olema.com) and will be archived for 14 days.
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 in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Olema is based in San Francisco and has operations in Cambridge, Massachusetts.Contact:
Eva Stroynowski
Vice President, Communications and Investor Relations
[email protected]
- Event: Jefferies London Healthcare Conference
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SAN FRANCISCO, Sept. 30, 2021 (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 announced a poster presentation on OP-1250, a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD) being developed for the treatment of metastatic breast cancer and other women's cancers, at the upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, being held virtually from October 7-10, 2021.
The trials in progress poster will summarize the design of the Company's ongoing Phase 1/2 open-label, first-in-human, multicenter, dose escalation and dose expansion study evaluating OP-1250 monotherapy in adult subjects with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer (NCT04505826). Preliminary data from the dose-escalation stage of the study are anticipated in Q4 2021.
Details of the poster presentation are as follows:
Poster Title: A Phase 1/2 Dose Escalation and Expansion Study of OP-1250 in Adults with Advanced and/or Metastatic Hormone Receptor-positive (HR+), HER2-negative (HER2-) Breast Cancer
Abstract Number: P037
Presentation Time: The e-poster will be available on the conference website on October 7, 2021 at 9:00 a.m. ET.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 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.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, including timelines related to data presentation, trial initiation and advancement, and enrollment. 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 filed on August 10, 2021 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.Contact:
Eva Stroynowski
Vice President, Communications and Investor Relations
[email protected]
-
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SAN FRANCISCO, Sept. 09, 2021 (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 announced a poster presentation of new preclinical data on OP-1250, a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD) being developed for the treatment of metastatic breast cancer and other women's cancers, at the 1st JCA-AACR Precision Cancer Medicine International Conference being held virtually from September 10-12, 2021 (U.S.) and September 11-12 (Japan).
A virtual e-poster presentation titled, "Complete Estrogen Receptor (ER) Antagonism As An Optimal Approach for ER-Positive Breast Cancer Drug Development," along with a pre-recorded audio narration will be available on-demand on the conference website.
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 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.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, including timelines related to data presentation, trial initiation and advancement, and enrollment, as well as the sufficiency of our financial resources. 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 to be filed on August 10, 2021 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.Contact:
Eva Stroynowski
Vice President, Communications and Investor Relations
[email protected]