OnKure Therapeutics, Inc.(OKUR) - 2025 Q2 - Quarterly Results

Executive Summary & Business Update Second Quarter 2025 Highlights OnKure Therapeutics reported its Q2 2025 financial results, highlighting a cash position of $83.4 million, expected to fund operations into Q4 2026, and continued progress in its lead asset, OKI-219 - Cash position of $83.4 million expected to provide cash runway into Q4 2026[2] - Continued progress in the development of lead asset, OKI-219, with enrollment completed for single agent and fulvestrant combination arms, and initiation of two new triplet arms[3] CEO Commentary President and CEO, Nick Saccomano, expressed encouragement regarding OKI-219's clinical performance and its potential in HR+ and HER2+ breast cancer, announcing new triplet arm initiations and plans to expand the PI3Kα franchise - OKI-219 has the potential to become an important medicine in the first-line hormone receptor positive setting[4] - Initiated an arm to evaluate OKI-219 in combination with fulvestrant and ribociclib in PI3KαH1047R mutated, metastatic HR+ breast cancer[4] - Initiated an arm to evaluate OKI-219 in combination with trastuzumab and tucatinib in HER2+ breast cancer[4] PI3Kα Portfolio Progress PIKture-01 Clinical Trial Updates The Phase 1 PIKture-01 clinical trial assessing OKI-219 in patients with advanced solid tumors is on track, with enrollment completed for monotherapy and fulvestrant combination arms, and new triplet combination arms initiated for HR+ and HER2+ metastatic breast cancer - PIKture-01, a phase 1 clinical trial assessing OKI-219, is on track for single agent and fulvestrant combination data in Q4 2025[6] Monotherapy and Fulvestrant Combination Enrollment for both monotherapy and fulvestrant combination dose escalation arms in the PIKture-01 trial has been completed and closed, with data expected in Q4 2025 - Enrollment completed and closed in both the monotherapy and fulvestrant combination dose escalation arms in the PIKture-01 trial[7] PIKture-01 Enrollment (as of August 5, 2025): | Arm | Patients Dosed | | :--- | :--- | | Monotherapy | 36 | | Combination with Fulvestrant | 34 | | Total | 70 | - OnKure expects to report data from both arms in the fourth quarter of 2025[7] Ribociclib Triplet Combination A new arm of PIKture-01 has been initiated to evaluate OKI-219 in combination with fulvestrant and ribociclib for PI3KαH1047R mutated, HR+ metastatic breast cancer, with an initial focus on safety - Initiated a new expansion arm of PIKture-01 to evaluate OKI-219 in combination with fulvestrant and ribociclib in HR+ metastatic breast cancer[6][7] - The initial phase of this arm will evaluate the safety of escalating doses of OKI-219 as part of a triplet combination[7] Tucatinib Triplet Combination A new arm of PIKture-01 has been initiated to evaluate OKI-219 in combination with trastuzumab and tucatinib for PI3KαH1047R mutated, HER2+ breast cancer, with an initial focus on safety - Initiated a new expansion arm of PIKture-01 to evaluate OKI-219 in combination with trastuzumab and tucatinib in HER2+ metastatic breast cancer[6][11] - The initial phase of this arm will evaluate the safety of escalating doses of OKI-219 as part of a triplet combination[11] Pan-mutant Selective Program OnKure is developing a third-generation PI3Kα compound targeting high selectivity against common PI3Kα mutations, aiming for a best-in-class pan-mutant inhibitor - Targeting approximately 10-fold selectivity over PI3Kα wild type against each of the most common mutations (PI3KαH1047X, PI3KαE542K, and PI3KαE545K)[11] - OnKure plans to announce the nomination of a development candidate by the end of 2025[11] Upcoming Investor Conferences Cantor Global Healthcare Investor Conference OnKure's President and CEO, Nicholas Saccomano, will participate in a fireside chat at the upcoming Cantor Global Healthcare investor conference on September 3, 2025, with a live audio webcast available - OnKure's President and CEO, Nicholas Saccomano, Ph.D., will participate in a fireside chat at the Cantor Global Healthcare investor conference on September 3, 2025, at 3:20 P.M. ET[9] - A live audio webcast can be accessed under 'News & Events' on the Investor section of OnKure's website, with a replay available for at least 90 days[9] Second Quarter 2025 Financial Results Financial Highlights OnKure reported key financial figures for Q2 2025, including a cash position of $83.4 million, increased R&D and G&A expenses, and a net loss of $15.4 million, with a significantly lower net loss per share due to increased shares outstanding Key Financial Highlights (Q2 2025 vs. Q2 2024): | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change (YoY) | | :--- | :--- | :--- | :--- | | Cash and cash equivalents (as of June 30) | $83.4 | N/A (Dec 31, 2024: $110.8) | Decrease | | Research and development (R&D) expenses | $12.6 | $10.8 | +$1.8 (+16.7%) | | General and Administrative (G&A) expenses | $3.7 | $3.6 | +$0.1 (+2.8%) | | Net loss | $(15.4) | $(14.1) | +$1.3 (+9.2%) | | Net loss per share | $(1.14) | $(44.82) | Significant decrease in loss per share due to increased shares outstanding | - Increase in R&D expenses primarily due to increased clinical trial, outsourced manufacturing, and research expenses[12] - Increase in G&A expenses primarily due to increased personnel-related costs, including share-based compensation charges, and increases in director compensation, consulting, filing fees, and other professional service fees, partially offset by a decrease in legal expenses[12] About OnKure Therapeutics Company Overview and Strategy OnKure Therapeutics is a clinical-stage biopharmaceutical company focused on developing best-in-class precision medicines that target biologically validated drivers of underserved cancers, utilizing a structure-based drug design platform with OKI-219 as its lead program - OnKure Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of best-in-class precision medicines that target biologically validated drivers of cancers that are underserved by available therapies[11][13] - The company uses a structure-based drug design platform to build a pipeline of tumor-agnostic candidates[11] - OnKure is currently developing OKI-219, a selective PI3KαH1047R inhibitor, as its lead program, aiming to become a leader in targeting oncogenic PI3Kα[13] Cautionary Note Regarding Forward-Looking Statements Forward-Looking Statements and Risks This section warns that the press release contains forward-looking statements that involve substantial risks and uncertainties, and actual results may differ materially from expectations. Investors should not rely on these statements as predictions of future events, and the company undertakes no obligation to update them - This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding future financial condition, results of operations, business strategy, and product candidates[14] - Key risks include OnKure's limited operating history, significant net losses, ability to raise additional capital, clinical development and regulatory approval risks, competition, intellectual property protection, and reliance on third parties[15] - Readers should not rely upon forward-looking statements as predictions of future events, and the company undertakes no obligation to update them publicly for any reason after the date of the press release, except as required by law[16] Financial Statements Condensed Consolidated Balance Sheets The condensed consolidated balance sheets provide a snapshot of OnKure's financial position, showing total assets of $86.07 million and total liabilities of $7.90 million as of June 30, 2025, compared to December 31, 2024 Condensed Consolidated Balance Sheets (in thousands, unaudited): | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $83,374 | $110,761 | | Prepaid expenses and other current assets | 1,178 | 2,242 | | Total current assets | 84,552 | 113,003 | | Property and equipment, net | 821 | 1,025 | | Operating lease, right-of-use asset | 581 | 770 | | Other assets | 116 | 109 | | Total assets | $86,070 | $114,907 | | Liabilities and Stockholders' Equity | | | | Accounts payable, accrued expenses, and other liabilities | $7,041 | $9,994 | | Operating lease liabilities, current portion | 556 | 536 | | Total current liabilities | 7,597 | 10,530 | | Long-term liabilities | 307 | 549 | | Total liabilities | 7,904 | 11,079 | | Stockholders' equity | 78,166 | 103,828 | | Total liabilities and stockholders' equity | $86,070 | $114,907 | Condensed Consolidated Statements of Operations and Comprehensive Loss The condensed consolidated statements of operations detail the company's financial performance for the three and six months ended June 30, 2025, showing increased operating expenses and net losses compared to the prior year, alongside a significant change in net loss per share due to increased weighted average shares outstanding Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts, unaudited): | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Operating expenses: | | | | | | Research and development | $12,613 | $10,752 | $25,625 | $19,318 | | General and administrative | 3,711 | 3,591 | 7,699 | 4,857 | | Total operating expenses | 16,324 | 14,343 | 33,324 | 24,175 | | Loss from operations | (16,324) | (14,343) | (33,324) | (24,175) | | Total other income and (expense), net | 934 | 204 | 2,009 | 500 | | Net loss and comprehensive loss | $(15,390) | $(14,139) | $(31,315) | $(23,675) | | Net loss per share, basic and diluted | $(1.14) | $(44.82) | $(2.33) | $(75.22) | | Weighted average shares outstanding, basic and diluted | 13,509,080 | 315,478 | 13,466,942 | 314,747 |