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Olema Oncology to Participate in Upcoming Investor Conferences in June
Newsfilter· 2024-05-28 11:03
SAN FRANCISCO, May 28, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. ("Olema", "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 its management team will participate in the following upcoming investor conferences: Jefferies Global Healthcare Conference Date: Wednesday, June 5, 2024, at 2:00 p.m. ET Location: Marriott Marquis in New York, NY Format: Fir ...
Olema Oncology Announces Promising New Data for Palazestrant in Combination with Ribociclib Presented at the 2024 ESMO Breast Cancer Congress
Newsfilter· 2024-05-15 11:01
Core Insights - Olema Pharmaceuticals announced interim results from a Phase 1b/2 clinical study of palazestrant (OP-1250) in combination with ribociclib for treating ER+/HER2- metastatic breast cancer, with results to be presented at the 2024 ESMO Breast Cancer Annual Congress [1][2] Enrollment and Study Design - As of March 13, 2024, 50 patients with recurrent, locally advanced or metastatic ER+/HER2- breast cancer were treated, with 74% being 2nd/3rd line+ and 70% having prior CDK4/6 inhibitors [3] - The study is fully enrolled with a total of 60 patients [3] Pharmacokinetics and Safety - Palazestrant showed high oral bioavailability, a half-life of eight days, and was well tolerated with no new safety signals [4][5] - The combination treatment had an 85% clinical benefit rate (CBR) across all eligible patients, indicating promising preliminary efficacy [4][5] Efficacy Results - The CBR was 83% in ESR1-mutant patients and 86% in ESR1-wild-type patients, with partial responses observed in five patients [5][8] - 66% of patients remained on treatment as of the data cut-off, with the longest duration on treatment being 44 weeks [8] Company Overview - Olema Oncology is focused on transforming the standard of care for women with cancer, advancing a pipeline of novel therapies including palazestrant, which has received FDA Fast Track designation [11][12]
Olema Pharmaceuticals(OLMA) - 2024 Q1 - Quarterly Report
2024-05-08 20:15
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number: 001-39712 OLEMA PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) Delawa ...
Olema Pharmaceuticals(OLMA) - 2024 Q1 - Quarterly Results
2024-05-08 20:06
[Corporate Update and Business Highlights](index=1&type=section&id=Olema%20Oncology%20Reports%20First%20Quarter%202024%20Financial%20Results%20and%20Provides%20Corporate%20Update) Olema Oncology provides Q1 2024 financial results and updates on clinical programs and upcoming milestones [Q1 2024 Highlights & Upcoming Milestones](index=1&type=section&id=First%20Quarter%202024%20Highlights%20%26%20Upcoming%20Milestones) Olema Oncology reported significant progress in its clinical programs during Q1 2024, including the completion of enrollment for Phase 1b/2 studies of palazestrant in combination with ribociclib and palbociclib - Completed enrollment in 60-patient Phase 1b/2 clinical studies of palazestrant in combination with both ribociclib and palbociclib[7](index=7&type=chunk)[8](index=8&type=chunk) - Nominated OP-3136, an orally bioavailable KAT6 inhibitor, as a new development candidate, with an Investigational New Drug (IND) application expected to be filed with the FDA in late 2024[7](index=7&type=chunk)[8](index=8&type=chunk)[9](index=9&type=chunk) - New clinical data from the palazestrant-ribociclib combination study will be presented at the ESMO Breast Cancer Annual Congress in May 2024, with an investor call scheduled for May 15, 2024[7](index=7&type=chunk)[8](index=8&type=chunk) - The company plans to initiate a Phase 1b/2 clinical study of palazestrant in combination with the mTOR inhibitor everolimus in Q3 2024[8](index=8&type=chunk) Cash Position | Metric | Amount | | :--- | :--- | | Cash, cash equivalents and marketable securities | $249.0 million | [First Quarter 2024 Financial Results](index=2&type=section&id=First%20Quarter%202024%20Financial%20Results) Olema Oncology reports its financial performance for Q1 2024, detailing net loss, operating expenses, and cash position [Financial Performance Summary](index=2&type=section&id=Financial%20Performance%20Summary) For the first quarter of 2024, Olema Oncology reported a net loss of $31.0 million, an increase from $28.3 million in the same period of 2023 Q1 Financial Snapshot | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net Loss | $31.0 million | $28.3 million | | Cash and Marketable Securities (as of Mar 31) | $249.0 million | N/A | Operating Expense Breakdown (GAAP) | Expense Category | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Research & Development (R&D) | $29.9 million | $22.8 million | | General & Administrative (G&A) | $4.5 million | $6.8 million | - The increase in R&D expenses was primarily driven by a **$5.0 million milestone payment** related to the Aurigene licensing agreement for the KAT6 inhibitor program and increased spending on late-stage clinical trials for palazestrant[12](index=12&type=chunk) - The decrease in G&A expenses was mainly due to lower corporate, legal, and personnel-related costs compared to the prior year, which included a one-time restructuring charge[14](index=14&type=chunk) [Detailed Financial Statements](index=6&type=section&id=Detailed%20Financial%20Statements) Detailed financial statements for Q1 2024 include the consolidated statement of operations and GAAP to Non-GAAP reconciliation [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The condensed consolidated statement of operations presents the company's net loss and operating expenses for Q1 2024 and Q1 2023 Q1 2024 Statement of Operations (in thousands, except per share data) | Line Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $29,883 | $22,826 | | General and administrative | $4,456 | $6,776 | | **Total operating expenses** | **$34,339** | **$29,602** | | Loss from operations | ($34,339) | ($29,602) | | Interest income | $3,352 | $1,305 | | **Net loss** | **($30,970)** | **($28,286)** | | Net loss per share, basic and diluted | ($0.56) | ($0.70) | [Reconciliation of GAAP to Non-GAAP Information](index=6&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Information) This section provides a reconciliation of GAAP to Non-GAAP expenses, adjusting for share-based compensation Q1 GAAP to Non-GAAP Reconciliation (in thousands) | Expense Category | GAAP | Share-Based Compensation | Non-GAAP | | :--- | :--- | :--- | :--- | | **Q1 2024 R&D** | $29,883 | ($3,412) | $26,471 | | **Q1 2023 R&D** | $22,826 | ($3,088) | $19,738 | | **Q1 2024 G&A** | $4,456 | ($1,497) | $2,959 | | **Q1 2023 G&A** | $6,776 | ($1,542) | $5,234 | [Other Information](index=3&type=section&id=Other%20Information) This section provides an overview of Olema Oncology's pipeline and details for an upcoming investor conference call [Company and Pipeline Overview](index=3&type=section&id=Company%20and%20Pipeline%20Overview) Olema Oncology is a clinical-stage biopharmaceutical company focused on women's cancers, with its lead product palazestrant for ER+/HER2- breast cancer - Palazestrant (OP-1250) is the company's lead product candidate, a novel, orally-available small molecule with dual activity as a complete ER antagonist (CERAN) and selective ER degrader (SERD)[18](index=18&type=chunk)[19](index=19&type=chunk) - Palazestrant is being evaluated in the pivotal Phase 3 OPERA-01 trial as a single agent and in Phase 1/2 combination studies with CDK4/6 inhibitors (palbociclib, ribociclib), a PI3Kα inhibitor (alpelisib), and an mTOR inhibitor (everolimus)[18](index=18&type=chunk) - In addition to palazestrant, Olema is developing OP-3136, a potent KAT6 inhibitor[19](index=19&type=chunk) [Investor Conference Call](index=3&type=section&id=ESMO%20Breast%20Cancer%20Investor%20Conference%20Call) Olema will host a webcast and conference call for analysts and investors on Wednesday, May 15, 2024, at 8:00 a.m. ET to review data - A conference call and webcast for investors is scheduled for May 15, 2024, at 8:00 a.m. ET to review data from the ESMO Breast Cancer Annual Congress[17](index=17&type=chunk)
Olema Oncology Reports First Quarter 2024 Financial Results and Provides Corporate Update
Newsfilter· 2024-05-08 20:02
Completed enrollment in 60-patient Phase 1b/2 clinical studies of palazestrant in combination with each of ribociclib and palbociclibNew clinical data from palazestrant-ribociclib combination study to be presented at the ESMO Breast Cancer Annual Congress 2024 in Berlin, Germany. Olema will host an investor conference call on May 15, 2024, at 8:00 a.m. ET to review the dataInvestigational New Drug (IND) application for OP-3136, a novel KAT6 inhibitor, expected to be filed with FDA in late 2024Cash, cash equ ...
Olema Oncology Announces New Clinical Data for Palazestrant in Combination with Ribociclib to be Presented at the 2024 ESMO Breast Cancer Annual Congress
Newsfilter· 2024-05-08 11:02
SAN FRANCISCO, May 08, 2024 (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 it will present new clinical data from the Company's ongoing Phase 1b/2 clinical study of palazestrant in combination with CDK4/6 inhibitor ribociclib in a poster presentation at the upcoming European Society for Medical Onco ...
Olema Oncology Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Newsfilter· 2024-05-02 20:37
SAN FRANCISCO, May 02, 2024 (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 the Company granted stock options to six new employees to purchase an aggregate of 187,400 shares of the Company's common stock, effective as of May 1, 2024. These awards were approved by the Compensation Committee of Olema ...
Olema Oncology to Participate in Upcoming Investor Conferences in May
Newsfilter· 2024-05-01 11:02
SAN FRANCISCO, May 01, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (("Olema", "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 its management team will participate in the following upcoming investor conferences: BofA Securities Health Care Conference 2024Date: Tuesday, May 14, 2024, at 4:35 p.m. PTLocation: Encore Hotel in Las Vegas, NVFormat: Presen ...
Olema Oncology to Participate in Upcoming Investor Conferences in May
Globenewswire· 2024-05-01 11:02
SAN FRANCISCO, May 01, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema”, “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 its management team will participate in the following upcoming investor conferences: BofA Securities Health Care Conference 2024Date: Tuesday, May 14, 2024, at 4:35 p.m. PTLocation: Encore Hotel in Las Vegas, NVFormat: Presen ...
Olema Pharmaceuticals(OLMA) - 2023 Q4 - Annual Report
2024-03-11 20:15
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission file number: 001-39712 OLEMA PHARMACEUTICALS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisd ...