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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- OP-1250 continues to advance in dose-escalation stage of Phase 1/2 clinical trial in patients with metastatic, ER+ / HER2- breast cancer; Initial data anticipated in 2H 2021
- Cash, cash equivalents, and marketable securities of $327.0 million as of March 31, 2021 sufficient to fund operations through the end of 2023
SAN FRANCISCO, May 11, 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 first quarter financial results for the period ended March 31, 2021.
"The first quarter of 2021 was very productive for Olema as we continued to advance our wholly-owned lead candidate, OP-1250, a complete estrogen receptor (ER) antagonist (CERAN), through dose escalation in the ongoing Phase 1/2 clinical trial in ER+ / HER2- breast cancer, and made substantial progress in building our organization," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Looking ahead, we remain on track to share initial clinical data at a medical meeting later this year and advance OP-1250 into Phase 2 monotherapy expansion. We also plan to initiate a Phase 1b study to evaluate OP-1250 in combination with a CDK4/6 inhibitor in the second half of 2021. We are in a strong financial position to execute on our strategy and are committed to working toward advancing the standard of care for people living with breast cancer."
Recent Corporate Highlights
- Presented nonclinical data on OP-1250 in a late-breaking poster session at the American Association for Cancer Research (AACR) Annual Meeting, held virtually from April 10-15, 2021. Data presented showed that 10 mg/kg OP-1250, a complete estrogen receptor (ER) antagonist (CERAN), was superior to tamoxifen, fulvestrant and ovariectomy in shrinking mutant ESR1-Y537S tumors in an intracranial model of ER+ breast cancer brain metastasis.
- Appointed Yi Larson to Olema's Board of Directors in April 2021. Ms. Larson currently serves as Chief Financial Officer at LianBio and brings significant biotech operational leadership and global healthcare banking expertise.
- Strengthened Olema's research and discovery capabilities with the opening of new laboratory facilities in San Francisco, CA.
Financial Highlights
- Cash, cash equivalents and marketable securities as of March 31, 2021 were $327.0 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 March 31, 2021 was $15.3 million, compared to $1.7 million for the same period of the prior year.
- Research and development (R&D) expenses were $10.7 million for the quarter ended March 31, 2021, compared to $0.8 million for the same period of the prior year. The increase in R&D expenses was primarily related to the increase in nonclinical development activities, execution of the ongoing Phase 1/2 clinical trial of OP-1250 and higher non-cash stock-based compensation expenses.
- General and administrative (G&A) expenses were $4.8 million for the quarter ended March 31, 2021, compared to $0.2 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 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 March 31, 2021 to be filed on May 11, 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) March 31, December 31, 2021 2020 (Unaudited) (Audited) Cash, cash equivalents and marketable securities $ 326,968 $ 338,549 Total assets $ 331,301 $ 342,722 Total liabilities $ 5,277 $ 4,585 Total stockholders' equity $ 326,024 $ 338,137 Total liabilities and stockholders' equity $ 331,301 $ 342,722 Olema Pharmaceuticals, Inc. Condensed consolidated statements of operations and comprehensive loss (In thousands, except share and per share data) Three Months Ended March 31, 2021 2020 (unaudited) Operating expenses: Research and development $ 10,692 $ 795 General and administrative 4,758 248 Total operating expenses (1) 15,450 1,043 Loss from operations (15,450 ) (1,043 ) Other (expense) income: Interest income 111 3 Interest expense - (653 ) Total other income (expense), net 111 (650 ) Net loss $ (15,339 ) $ (1,693 ) Net loss per share, basic and diluted $ (0.39 ) $ (0.65 ) Weighted average shares used to compute net loss per share, basic and diluted 39,325,793 2,593,316 (1) Total operating expenses includes the following non-cash stock-based compensation expenses: Three Months Ended March 31, 2021 2020 (unaudited) Research and development expenses $ 1,734 $ - General and administrative 1,474 - $ 3,208 $ -
Contact:
Eva Stroynowski
Vice President, Communications and Investor Relations
[email protected]
617-721-8194
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SAN FRANCISCO, April 07, 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 Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the Canaccord Genuity Horizons in Oncology Virtual Conference on Thursday, April 15 at 12 p.m. ET. The fireside chat will be moderated by Arlinda Lee, Ph.D., Managing Director, Biotechnology Analyst at Canaccord Genuity.
A live webcast of the event will be accessible in the Investors & Media section of Olema's website. A replay of the webcast will be available.
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.Investor Contact:
[email protected]Media Contact:
Sheryl Seapy, Real Chemistry
[email protected]
949-903-4750 -
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- Ms. Larson Brings Significant Biotech Operational Leadership and Global Healthcare Banking Expertise to Olema as the Company Continues to Advance Its Pipeline
- Longstanding Olema Director Dr. Frank McCormick to Transition from Board of Directors and Return to His Position as Chairman of Olema's Scientific Advisory Board
SAN FRANCISCO, April 06, 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 the appointment of Yi Larson to the company's Board of Directors, and the transition of longstanding Olema director Frank McCormick, Ph.D., F.R.S., D.Sc., to Chair of Olema's Scientific Advisory Board.
"Yi joins Olema at a pivotal time, as we advance the clinical development of our lead program, OP-1250, in breast cancer, and expand our research and development operations," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema. "Her demonstrated global operational expertise as Chief Financial Officer of Turning Point Therapeutics, coupled with her extensive capital markets and healthcare banking experience, position her well to provide valuable insights and experience to the Board. We also are fortunate to have Dr. McCormick continue to advise the company as Chair of our Scientific Advisory Board. Given his significant track record in starting and advising numerous successful oncology companies, and his experience on our Board of Directors since 2014, his support and guidance have been immeasurable and have enabled us to move into the clinic with OP-1250."
"I am impressed with Olema's science on the estrogen receptor and the potential of its pipeline to improve the lives of women living with breast cancer, and I could not be more excited to join Olema's Board of Directors as it advances its clinical trials of OP-1250," said Ms. Larson.
"On behalf of Olema and the Board of Directors, I welcome Yi to the Board and look forward to working with her as we execute on the company's mission," said Ian Clark, Chairman of the Olema Board of Directors. "I am also pleased that Dr. McCormick will continue to advise Olema and our scientific and clinical teams on strategies to advance our pipeline. We thank him for his significant contributions to the company as a director."
Ms. Larson most recently served as Chief Financial Officer of Turning Point Therapeutics, where she oversaw a period of tremendous growth. Effective May 1, 2021, she will become Chief Financial Officer of LianBio, a private biotech company focusing on precision and innovative therapeutics with operations in the United States and China. Prior to Turning Point, Ms. Larson was a Managing Director of Healthcare Investment Banking at Goldman Sachs, where she successfully executed over 50 transactions, including approximately $70 billion in merger and acquisition activities and $30 billion in financings. She earned an MBA, concentrated in finance, from The Wharton School at the University of Pennsylvania, and a master's degree in electrical engineering and computer science and a bachelor's degree in electrical engineering from the Massachusetts Institute of Technology.
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, advancement of Olema's pipeline and expansion of research and development operations. 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, 2020, filed on March 17, 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.Investor Contact:
[email protected]Media Contact:
Sheryl Seapy, Real Chemistry
[email protected]
949-903-4750 -
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- Advancing OP-1250 in metastatic, ER+ / HER2- breast cancer Phase 1/2 clinical trial
- Clinical trial agreements announced with Novartis and Pfizer to explore combination of OP-1250 with CDK4/6 inhibitors and PI3Kα inhibitor
- Approximately $382 million in gross proceeds raised across Series B, Series C and Initial Public Offering financings
- Cash and cash equivalents of $338.5 million as of December 31, 2020 sufficient to fund operations through 2022
SAN FRANCISCO, March 17, 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 reported financial results for the fourth quarter and full year ended December 31, 2020 and provided a business update.
"2020 was a momentous year for Olema, marked by the achievement of several important milestones including the initiation of our Phase 1/2 clinical trial for OP-1250 in ER+ / HER2- breast cancer as well as Series B and C financings, culminating in our Initial Public Offering in November." said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We continue to execute on our strategy and enrollment in our ongoing clinical trial remains on-track, with data to be presented at a scientific meeting later this year."
2020 Corporate Highlights
- Advanced Olema's lead program, OP-1250, through investigational new drug (IND) filing and initiated a Phase 1/2 dose escalation and dose expansion clinical trial for the treatment of recurrent, locally advanced or metastatic estrogen receptor (ER)-positive, or ER+, human epidermal growth factor receptor 2-negative, or HER2-, breast cancer. Initial data from this trial are expected to be reported in the second half of 2021.
- In July 2020, entered into non-exclusive clinical collaboration with Novartis to evaluate the combination of OP-1250 and ribociclib (KISQALI®), a CDK4/6 inhibitor, as well as apelisib (PIQRAY®), a PI3Kα inhibitor in patients with ER+ / HER2- breast cancer.
- In November 2020, entered into non-exclusive clinical trial agreement with Pfizer to evaluate the combination of OP-1250 and palbociclib (IBRANCE®), a CDK4/6 inhibitor in patients with ER+ / HER2- breast cancer.
- Expanded discovery research efforts with additions to the research team as well as new laboratory facilities.
- Raised approximately $382 million in gross proceeds across Series B, Series C and Initial Public Offering financings before deducting underwriting discounts, commissions and other offering expenses.
- Strengthened Olema's management team and Board of Directors in 2020 by adding seasoned and experienced industry leaders across the executive functions.
Financial Highlights
- Cash and cash equivalents as of December 31, 2020 were $338.5 million. The company anticipates that the year-end balance of cash will be sufficient to fund operations through 2022.
- Net loss for the fourth quarter ended December 31, 2020 was $10.1 million compared to $1.0 million for the fourth quarter ended December 31, 2019. Net loss for the year ended December 31, 2020 was $24.0 million compared to $4.3 million for the year ended December 31, 2019.
- Research and development (R&D) expenses were $6.3 million for the fourth quarter ended December 31, 2020 compared to $0.9 million for the fourth quarter ended December 31, 2019. Research and development expenses were $13.7 million for the year ended December 31, 2020 compared to $3.9 million for the year ended December 31, 2019. The increase in R&D expenses was primarily related to increase in preclinical development activities, the IND filing and initiation of the Phase 1/2 clinical trial of OP-1250 and higher non-cash stock-based compensation expenses.
- General and administrative (G&A) expenses were $3.8 million for the fourth quarter ended December 31, 2020, compared to $0.1 million for the fourth quarter ended December 31, 2019. General and administrative expenses were $7.8 million for the year ended December 31, 2020, compared to $0.4 million for the year ended December 31, 2019. The increase in G&A expenses was primarily due 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 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 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 Annual Report on Form 10-K for the year ended December 31, 2020 to be filed on March 17, 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 Balance Sheets Data (in thousands) December 31, 2020 2019 Cash and cash equivalents $ 338,549 $ 68 Total assets $ 342,722 $ 132 Current liabilities $ 4,585 $ 1,378 Total liabilities $ 4,585 $ 1,378 Total stockholders' equity (deficit) $ 338,137 $ (10,594 ) Total liabilities, convertible preferred stock and stockholders' equity (deficit) $ 342,722 $ 132 Olema Pharmaceuticals, Inc. Statements of operations and comprehensive loss (In thousands, except share and per share data) Three Months Ended December 31, Years Ended December 31, 2020 2019 2020 2019 (unaudited) (audited) Operating expenses: Research and development $ 6,289 $ 910 $ 13,704 $ 3,920 General and administrative 3,842 107 7,824 403 Total operating expenses (1) 10,131 1,017 21,528 4,323 Loss from operations (10,131 ) (1,017 ) (21,528 ) (4,323 ) Other (expense) income: Interest income - - 60 7 Interest expense - - (653 ) - Total other (expense) income, net - - (593 ) 7 Net loss and comprehensive loss $ (10,131 ) $ (1,017 ) $ (22,121 ) $ (4,316 ) Repurchase and retirement of Series A and Series A-1 convertible preferred stock - - (1,869 ) - Net loss attributable to common stockholders $ (10,131 ) $ (1,017 ) $ (23,990 ) $ (4,316 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.50 ) $ (0.39 ) $ (3.42 ) $ (1.66 ) Weighted average shares used to compute net loss per share attributable to common stockholders, basic and diluted (2) 20,155,342 2,593,316 7,021,468 2,593,316 (1) Total operating expenses includes the following non-cash stock-based compensation expenses: Three Months Ended December 31, Years Ended December 31, 2020 2019 2020 2019 Research and development expenses $ 1,475 $ - $ 1,970 $ - General and administrative 867 - 1,108 - $ 2,342 $ - $ 3,078 $ - (2) The weighted average shares used to compute net loss attributable to common stockholders includes 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. Investor Contact:
[email protected]Media Contact:
Sheryl Seapy, Real Chemistry
[email protected]
949-903-4750 - Advancing OP-1250 in metastatic, ER+ / HER2- breast cancer Phase 1/2 clinical trial
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SAN FRANCISCO, March 10, 2021 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology"), 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 American Association for Cancer Research (AACR) Annual Meeting to be held virtually from April 10-15, 2021.
The abstract of the poster was accepted by AACR as a late-breaking abstract and will be posted to the AACR online itinerary planner on April 9, 2021. Details of the poster presentation are as follows:
Poster Title: The Complete Estrogen Receptor Antagonist (CERAN) OP-1250 Shrinks ER+ Brain Metastases in an Intracranial Xenograft Tumor Model Expressing Mutant ESR1
Presentation Time: The e-poster will be available on the AACR website on Saturday, April 10, 2021.
Abstract Control Number: 5478
Session Type: E-Poster Session
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents
Permanent Abstract Number: LB122About 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 "believe," "anticipate," "plan," "expect," "intend," "will," "may," "goal," "project," "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 potential safety, functional characteristics and efficacy of OP-1250; and Olema's ability to successfully advance, and the potential timelines for, the development of OP-1250. 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 sections titled "Risk Factors" in Olema's prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, on November 19, 2020, 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.
Contacts
Investor Contact:
[email protected]Media Contact:
Sheryl Seapy, W2O
[email protected]
949-903-4750