{"id":958470,"date":"2026-05-05T17:33:27","date_gmt":"2026-05-05T21:33:27","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/onkure-therapeutics-reports-first-quarter-2026-financial-results\/"},"modified":"2026-05-05T17:33:27","modified_gmt":"2026-05-05T21:33:27","slug":"onkure-therapeutics-reports-first-quarter-2026-financial-results","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/onkure-therapeutics-reports-first-quarter-2026-financial-results\/","title":{"rendered":"OnKure Therapeutics Reports First Quarter 2026 Financial Results"},"content":{"rendered":"
\n

\n — Announced nomination of OKI-355, a next-generation PI3K\u03b1 <\/em>
\n pan-mutant selective inhibitor candidate, in vascular anomalies<\/em>\n <\/p>\n

\n — Initiated a discovery research program to expand the company\u2019s pipeline in vascular anomalies<\/em>\n <\/p>\n

\n — Announced nomination of OKI-345, a next generation PI3K\u03b1<\/em>
\n \u00a0pan-mutant selective inhibitor candidate, in breast cancer<\/em>\n <\/p>\n

\n — Closed $150 million private placement to advance next-generation PI3K\u03b1<\/em>
\n \u00a0pan-mutant programs into clinical development in 2027<\/em>\n <\/p>\n

\n — $192 million cash and cash equivalents as of March 31, 2026, expected to fund operations into 2029<\/em>\n <\/p>\n

BOULDER, Colo., May 05, 2026 (GLOBE NEWSWIRE) — OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines, today reported financial results for the first quarter ended March 31, 2026, and provided recent business highlights.<\/p>\n

\u201cDuring the first quarter, we sharpened our strategic focus on advancing our next generation PI3K\u03b1\u00a0<\/em>pan-mutant selective inhibitor programs, which we believe represent the most compelling opportunity to deliver differentiated therapies across PI3K\u03b1-driven diseases,\u201d said Nicholas Saccomano, Ph.D., President and Chief Executive Officer of OnKure. \u201cBuilding on insights gained from our earlier clinical and translational work, we have advanced two highly selective pan-mutant development candidates that were purpose designed to achieve robust target coverage while avoiding class limiting toxicities. As we move forward with OKI-355 in vascular anomalies and OKI-345 in breast cancer, our focus is on translating the strengths of our chemistry platform and deep understanding of\u00a0PI3K\u03b1 biology into programs with the potential to deliver meaningful, differentiated, and durable benefit to patients.\u201d<\/p>\n

\n Vascular Anomalies<\/strong>\n <\/p>\n

OnKure recently announced the selection of OKI-355, an advanced next-generation PI3K\u03b1 pan-mutant selective inhibitor candidate, to lead its development pipeline in vascular anomalies. OKI-355 has been designed to selectively inhibit mutant PI3K\u03b1 while sparing wildtype PI3K\u03b1, potentially enabling a wider therapeutic index and avoidance of class-limiting toxicities. High and sustained target coverage across all hotspot PI3K\u03b1 mutations can support the potential for deep and durable responses in vascular anomalies. Additionally, the Company initiated a discovery research program to expand OnKure\u2019s pipeline in vascular anomalies.\u00a0<\/p>\n

OnKure plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for OKI\u2011355 in the first half of 2027.<\/p>\n

\n
\n Breast Cancer <\/u>
\n <\/strong>\n <\/p>\n

OnKure recently announced the selection of OKI-345, an advanced next-generation PI3K\u03b1 pan-mutant selective inhibitor candidate in breast cancer. Like OKI-355, OKI-345 has been designed to selectively inhibit mutant PI3K\u03b1 while sparing wildtype PI3K\u03b1, potentially enabling a wider therapeutic index and avoidance of class-limiting toxicities. High and sustained target coverage across all hotspot PI3K\u03b1 mutations can support the potential for deep and durable responses in breast cancer, both as monotherapy and in combination.\u00a0 OnKure plans to submit an IND application to the FDA for OKI\u2011345 in the first half of 2027.<\/p>\n

Given the Company\u2019s strategic focus on advancing its next-generation PI3K\u03b1 pan-mutant inhibitors, OnKure is not planning to independently pursue further clinical development of OKI-219, a highly selective PI3K\u03b1H1047<\/sup> mutant-specific inhibitor, at this time. \u00a0The Company plans to report data from PIKture-01 by the end of 2026.\u00a0 Additional information about PIKture-01 may be found at www.ClinicalTrials.gov<\/a>, using Identifier: NCT06239467.<\/p>\n

\n
\n Upcoming Conference<\/u>
\n <\/strong>\n <\/p>\n

OnKure will participate as an exhibitor and sponsor in the International Society and Study of Vascular Anomalies (ISSVA) World Congress 2026 in Philadelphia, May 19-22, 2026.<\/p>\n

\n
\n Financial Results<\/u>
\n <\/strong>\n <\/p>\n

\n Cash and cash equivalents<\/strong> were\u00a0 $192.1 million as of March 31, 2026, including proceeds from the oversubscribed $150 million private placement, which closed on March 31, 2026.<\/p>\n

\n Research and development (R&D) expenses<\/strong> were $11.7 million for the first quarter of 2026, compared to $13.0 million for the first quarter of 2025. The decrease of $1.3 million was primarily driven by a decrease in outsourced R&D related expenses, partially offset by increased clinical trial costs.<\/p>\n

\n General and Administrative (G&A) expenses<\/strong> were $3.9 million for the first quarter of 2026, compared to $4.0 million for the first quarter of 2025. The decrease of $0.1 million was primarily driven by a decrease in legal and filing service costs, partially offset by increased personnel-related costs.<\/p>\n

\n Net loss and net loss per share<\/strong> were $15.2 million, or $1.11 per share, for the first quarter of 2026, compared to $15.9 million, or $1.19 per share, for the first quarter of 2025.<\/p>\n

\n About the PIKture-01 Study<\/strong>\n <\/p>\n

PIKture-01 is a global, multi-center, dose-escalation, first-in-human phase 1a\/1b study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and efficacy of OKI-219 as monotherapy and in combination with other anti-cancer drugs for the treatment of HR+ and HER2+ advanced breast cancer.\u00a0 As of March 26, 2026, the PIKture-01 trial has completed enrollment in single-agent OKI-219 dose escalation (n=38) and OKI-219 + fulvestrant dose escalation (n=33). Phase 2 dose evaluation in the OKI-219 + tucatinib and trastuzumab triplet and the OKI-219 + ribociclib and fulvestrant triplets will be completed in 2026. Given the progress of the Company\u2019s PI3K\u03b1 pan-mutant inhibitors, OnKure is not planning to pursue further clinical development of OKI-219 independently at this time. \u00a0Additional information about PIKture-01 may be found at www.ClinicalTrials.gov<\/a>, using Identifier: NCT06239467.<\/p>\n

\n About OnKure Therapeutics<\/strong>\n <\/p>\n

OnKure Therapeutics (Nasdaq: OKUR) is a clinical-stage biopharmaceutical company focused on the discovery and development of best-in-class precision medicines that target biologically validated drivers of vascular anomalies and cancers that are underserved by available therapies. Using a structure and computational chemistry-driven drug design platform, OnKure is committed to improving clinical outcomes for patients by building a pipeline of small molecule drugs designed to\u00a0 selectively target specific mutations thought to be key drivers of vascular anomalies and cancer. OnKure aims to become a leader in targeting PI3K\u03b1 and has multiple programs designed to enable best-in-class targeting of this key oncogene.<\/p>\n

For more information about OnKure, visit us at www.onkure.com<\/a> and follow us on LinkedIn.<\/p>\n

\n Cautionary Note Regarding Forward-Looking Statements<\/strong>\n <\/p>\n

\n This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding, OnKure\u2019s product candidates and programs, including OKI-355 and OKI-345; OnKure\u2019s ability to advance additional programs;\u00a0 expected milestones and the timing of such milestones, including additional data from, and completion of enrollment in, the PIKture-01 trial, and the submission of IND applications for OKI-355 and OKI-345; OnKure\u2019s expected cash runway; and statements by OnKure\u2019s President and Chief Executive Officer. In some cases, you can identify forward-looking statements by terminology such as \u201cexpect,\u201d \u201cestimate,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpotentially,\u201d \u201cwill\u201d or the negative of these terms or other similar expressions.<\/em>\n <\/p>\n

\n These forward-looking statements are based largely on OnKure\u2019s current expectations and projections about future events and trends that OnKure believes may affect its financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: OnKure\u2019s limited operating history; the significant net losses incurred since inception; the ability to raise additional capital to finance operations; the risk that actual uses of cash and cash equivalents differ from the assumptions underlying OnKure\u2019s expected cash runway; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize, OnKure\u2019s product candidates; the outcome of preclinical testing and early clinical trials for OnKure\u2019s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements and the potential that the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials; OnKure\u2019s limited resources; the risk of adverse events, toxicities or other undesirable side effects; potential delays or difficulties in the enrollment or maintenance of patients in clinical trials; the decision to develop or seek strategic collaborations to develop OnKure\u2019s current or future product candidates in combination with other therapies and the cost of combination therapies; OnKure\u2019s limited experience in designing clinical trials and lack of experience in conducting clinical trials; the substantial competition OnKure faces in discovering, developing, or commercializing products; OnKure\u2019s ability to protect its intellectual property and proprietary technologies; developments relating to OnKure\u2019s competitors and its industry, including competing product candidates and therapies; reliance on third parties, contract manufacturers, and contract research organizations; legislative, regulatory, political and economic developments and general market conditions; and those risks described in the section entitled \u201cRisk Factors\u201d in documents that OnKure files from time to time with the SEC, including its Report on Form 10-Q filed with the SEC on May 5, 2026 and any subsequent filings with the SEC. These risks are not exhaustive. New risk factors emerge from time to time, and it is not possible for OnKure\u2019s management to predict all risk factors, nor can OnKure assess the impact of all factors on OnKure\u2019s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although OnKure believes that the expectations reflected in the forward-looking statements are reasonable, OnKure cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, OnKure undertakes no obligation to update publicly any forward-looking statements for any reason after the date of this press release.<\/em>\n <\/p>\n

\n Contact:<\/strong>\n <\/p>\n

Dan Ferry
LifeSci Advisors
daniel@lifesciadvisors.com<\/a><\/p>\n

\n ONKURE THERAPEUTICS, INC.<\/strong>
\n
\n Condensed Consolidated Balance Sheets<\/strong>
\n
\n (In thousands, unaudited)<\/strong>\n <\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n \u00a0<\/strong>\n <\/td>\n\n \u00a0<\/strong>\n <\/td>\n\n March 31,
2026<\/strong>\n <\/td>\n		\n \u00a0<\/strong>\n <\/td>\n\n \u00a0<\/strong>\n <\/td>\n\n December\u00a031,
2025<\/strong>\n <\/td>\n		\n \u00a0<\/strong>\n <\/td>\n<\/tr>\n
\n \u00a0<\/strong>\n <\/td>\n\n \u00a0<\/strong>\n <\/td>\n\n \u00a0<\/strong>\n <\/td>\n\n \u00a0<\/strong>\n <\/td>\n\n \u00a0<\/strong>\n <\/td>\n\n \u00a0<\/strong>\n <\/td>\n\n \u00a0<\/strong>\n <\/td>\n<\/tr>\n
\n Assets<\/strong>\n <\/td>\n\n \u00a0<\/strong>\n <\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
Current assets:<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
Cash and cash equivalents<\/td>\n\u00a0<\/td>\n$<\/td>\n192,106<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n$<\/td>\n59,050<\/td>\n\u00a0<\/td>\n<\/tr>\n
Prepaid expenses and other current assets<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n5,376<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n1,789<\/td>\n\u00a0<\/td>\n<\/tr>\n
Total current assets<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n197,482<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n60,839<\/td>\n\u00a0<\/td>\n<\/tr>\n
Property and equipment, net<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n519<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n618<\/td>\n\u00a0<\/td>\n<\/tr>\n
Operating lease, right-of-use asset<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n288<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n387<\/td>\n\u00a0<\/td>\n<\/tr>\n
Other assets<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n405<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n273<\/td>\n\u00a0<\/td>\n<\/tr>\n
Total assets<\/td>\n\u00a0<\/td>\n$<\/td>\n198,694<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n$<\/td>\n62,117<\/td>\n\u00a0<\/td>\n<\/tr>\n
\n Liabilities and Stockholders\u2019 Equity<\/strong>\n <\/td>\n\n \u00a0<\/strong>\n <\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
Current liabilities:<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
Accounts payable, accrued expenses, and other liabilities<\/td>\n\u00a0<\/td>\n$<\/td>\n13,920<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n$<\/td>\n5,372<\/td>\n\u00a0<\/td>\n<\/tr>\n
Operating lease liabilities, current portion<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n409<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n549<\/td>\n\u00a0<\/td>\n<\/tr>\n
Total current liabilities<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n14,329<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n5,921<\/td>\n\u00a0<\/td>\n<\/tr>\n
Long-term liabilities<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n12<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n12<\/td>\n\u00a0<\/td>\n<\/tr>\n
Total liabilities<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n14,341<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n5,933<\/td>\n\u00a0<\/td>\n<\/tr>\n
Stockholders\u2019 equity<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n184,353<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n56,184<\/td>\n\u00a0<\/td>\n<\/tr>\n
Total liabilities and stockholders\u2019 equity<\/td>\n\u00a0<\/td>\n$<\/td>\n198,694<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n$<\/td>\n62,117<\/td>\n\u00a0<\/td>\n<\/tr>\n<\/table>\n

\n \n <\/p>\n

\n ONKURE THERAPEUTICS, INC.<\/strong>
\n
\n Condensed Consolidated Statements of Operations and Comprehensive Loss<\/strong>
\n
\n (In thousands, except share and per share data, unaudited)<\/strong>\n <\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\u00a0<\/td>\n\n Three Months Ended<\/strong>\n <\/td>\n\u00a0<\/td>\n<\/tr>\n
\u00a0<\/td>\n\n March 31,<\/strong>\n <\/td>\n\u00a0<\/td>\n<\/tr>\n
\u00a0<\/td>\n\n 2026<\/strong>\n <\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\n 2025<\/strong>\n <\/td>\n\u00a0<\/td>\n<\/tr>\n
\n Operating expenses:<\/strong>\n <\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
Research and development<\/td>\n$<\/td>\n11,707<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n$<\/td>\n13,012<\/td>\n\u00a0<\/td>\n<\/tr>\n
General and administrative<\/td>\n\u00a0<\/td>\n3,908<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n3,988<\/td>\n\u00a0<\/td>\n<\/tr>\n
Total operating expenses<\/td>\n\u00a0<\/td>\n15,615<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n17,000<\/td>\n\u00a0<\/td>\n<\/tr>\n
\n Loss from operations<\/strong>\n <\/td>\n\u00a0<\/td>\n(15,615)<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n(17,000)<\/td>\n\u00a0<\/td>\n<\/tr>\n
Other income:<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
Interest income<\/td>\n\u00a0<\/td>\n458<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n1,075<\/td>\n\u00a0<\/td>\n<\/tr>\n
\n Net loss and comprehensive loss<\/strong>\n <\/td>\n$<\/td>\n(15,157)<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n$<\/td>\n(15,925)<\/td>\n\u00a0<\/td>\n<\/tr>\n
\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
Net loss per share attributable to common stockholders:<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
Basic and diluted<\/td>\n$<\/td>\n(1.11)<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n$<\/td>\n(1.19)<\/td>\n\u00a0<\/td>\n<\/tr>\n
Weighted average shares outstanding:<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
Basic and diluted<\/td>\n\u00a0<\/td>\n13,674,577<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n13,424,335<\/td>\n\u00a0<\/td>\n<\/tr>\n<\/table>\n

\n \n <\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

— Announced nomination of OKI-355, a next-generation PI3K\u03b1 pan-mutant selective inhibitor candidate, in vascular anomalies — Initiated a discovery research program to expand the company\u2019s pipeline in vascular anomalies — Announced nomination of OKI-345, a next generation PI3K\u03b1 \u00a0pan-mutant selective inhibitor candidate, in breast cancer — Closed $150 million private placement to advance next-generation PI3K\u03b1 \u00a0pan-mutant programs into clinical development in 2027 — $192 million cash and cash equivalents as of March 31, 2026, expected to fund operations into 2029 BOULDER, Colo., May 05, 2026 (GLOBE NEWSWIRE) — OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines, today reported financial results for the first quarter ended March 31, 2026, and provided recent business highlights. … <\/p>\n

Continue reading “OnKure Therapeutics Reports First Quarter 2026 Financial Results”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-958470","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nOnKure Therapeutics Reports First Quarter 2026 Financial Results - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/onkure-therapeutics-reports-first-quarter-2026-financial-results\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"OnKure Therapeutics Reports First Quarter 2026 Financial Results - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"— Announced nomination of OKI-355, a next-generation PI3K\u03b1 pan-mutant selective inhibitor candidate, in vascular anomalies — Initiated a discovery research program to expand the company\u2019s pipeline in vascular anomalies — Announced nomination of OKI-345, a next generation PI3K\u03b1 \u00a0pan-mutant selective inhibitor candidate, in breast cancer — Closed $150 million private placement to advance next-generation PI3K\u03b1 \u00a0pan-mutant programs into clinical development in 2027 — $192 million cash and cash equivalents as of March 31, 2026, expected to fund operations into 2029 BOULDER, Colo., May 05, 2026 (GLOBE NEWSWIRE) — OnKure Therapeutics, Inc. 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