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Olema Pharmaceuticals(OLMA) - 2024 Q1 - Quarterly Results

Corporate Update and Business Highlights Olema Oncology provides Q1 2024 financial results and updates on clinical programs and upcoming milestones Q1 2024 Highlights & Upcoming Milestones 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 palbociclib78 - 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 2024789 - 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, 202478 - The company plans to initiate a Phase 1b/2 clinical study of palazestrant in combination with the mTOR inhibitor everolimus in Q3 20248 Cash Position | Metric | Amount | | :--- | :--- | | Cash, cash equivalents and marketable securities | $249.0 million | First Quarter 2024 Financial Results Olema Oncology reports its financial performance for Q1 2024, detailing net loss, operating expenses, and cash position Financial Performance Summary 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 palazestrant12 - 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 charge14 Detailed Financial Statements Detailed financial statements for Q1 2024 include the consolidated statement of operations and GAAP to Non-GAAP reconciliation Condensed Consolidated Statements of Operations 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 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 This section provides an overview of Olema Oncology's pipeline and details for an upcoming investor conference call Company and Pipeline Overview 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)1819 - 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 - In addition to palazestrant, Olema is developing OP-3136, a potent KAT6 inhibitor19 Investor Conference Call 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 Congress17