Tucatinib

NASHVILLE, Tenn.--(BUSINESS WIRE)-- Sarah Cannon Research Institute (SCRI) , one of the world’s leading oncology research organizations conducting community-based clinical trials, will present new data across more than 155 abstracts and presentations at the 2026 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place in Chicago from May 29–June 2, 2026. The data reflect contributions from over 85 authors and coauthors across more than 30 research sites in SCRI’s network and include findings from both early- and late-phase clinical trials. These findings underscore SCRI’s role in advancing innovative therapies from first-in-human studies to practice-changing science leveraging the network’s scientific leadership and expansive community-based research footprint. “The breadth of research presented by SCRI investigators at this year’s ASCO Annual Meeting reflects the unique role SCRI plays in cancer clinical research,” said David R. Spigel, MD, President and Chief Medical Officer, SCRI. “Our work provides patients access to the best available research options and expert care in the communities where they live. Everyone facing cancer should have the opportunity to participate in trials with new agents without having to travel great distances away from their families and homes. We look forward to sharing our latest insights with the global oncology community in Chicago.” For a comprehensive list of SCRI abstracts and presentations, visit SCRI’s ASCO Site . To learn more about our research experts, visit the SCRI Leadership page . Noteworthy Presentations Blood Cancer & Blood Disorders Hans Lee, MD, SCRI , will deliver “ First Results from the Phase 1/2 LINKER-AL2 Trial of Linvoseltamab in Patients with Relapsed or Refractory Systemic Light Chain Amyloidosis ” in an oral presentation on Friday, May 29 at 3:09 p.m. CDT during the session, Hematologic Malignancies—Plasma Cell Dyscrasia in S100a. Peter Forsberg, MD, SCRI at Colorado Blood Cancer Institute , will present “ Optec/Optal: A Phase 2 Study to Evaluate Outpatient, Step-Up Administration of Teclistamab or Talquetamab with Prophylactic Tocilizumab in Patients with Relapsed/Refractory Multiple Myeloma ” in an oral presentation on Sunday, May 31 at 9:51 a.m. CDT during the session, Hematologic Malignancies—Plasma Cell Dyscrasia in E450a. John Burke, MD, SCRI at Rocky Mountain Cancer Centers | The US Oncology Network , is coauthor on the Late Breaking Abstract, “ frontMIND: Phase 3 Study of Tafasitamab plus Lenalidomide and R-CHOP for Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma ” that will be presented on Saturday, May 30 at 3:00 p.m. CDT as part of the session, Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia in the Arie Crown Theater. Breast Cancer Erika Hamilton, MD, SCRI , will deliver “ Efficacy and Safety of Tucatinib vs Placebo Combined with Trastuzumab and Pertuzumab as Maintenance Therapy for HER2+ Metastatic Breast Cancer by Stratified Subgroups ” in an oral presentation on Tuesday, June 2 at 11:09 a.m. CDT as part of the session, Breast Cancer—Metastatic in Hall D1. Mabel Mardones, MD, SCRI at Rocky Mountain Cancer Centers | The US Oncology Network , is a coauthor on the Late Breaking Abstract, “ Giredestrant + Palbociclib vs Letrozole + PALBO as First-Line Therapy in Patients with Estrogen Receptor–Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer: Primary Analysis of the Phase III persevERA BC Trial ” that will be presented on Tuesday, June 2 at 11:45 a.m. CDT during the session, Breast Cancer—Metastatic in Hall D1. Lung Cancer Melissa Johnson, MD, SCRI , is coauthor on the Late Breaking Abstract, “ Event-Free Survival with Adjuvant Selpercatinib in Stage IB-IIIA RET Fusion-Positive NSCLC: Primary Results of the Phase 3 LIBRETTO-432 Trial ” that will be presented during the Plenary Session on Sunday, May 31 at 2:13 p.m. CDT in Hall B1. Melanoma & Skin Cancers Meredith McKean, MD, MPH, SCRI , is coauthor on the Late Breaking Abstract, “ Darovasertib Plus Crizotinib vs Investigator’s Choice as First-Line Treatment for Patients with HLA-A2 Negative Metastatic Uveal Melanoma: Primary Results from the OptimUM-02 Trial ” that will be presented on Monday, June 1 at 9:00 a.m. CDT during the session, Melanoma/Skin Cancers in S100bc. Additional James Essell, MD, SCRI at OHC | The US Oncology Network , will deliver the oral “ Impact of Remote Therapeutic Monitoring with Patient-Reported Outcomes on Hospitalization in Real-World Patients Receiving Therapy for Metastatic Solid Tumors ” that will be presented on Sunday, May 31 at 9:24 a.m. CDT during the session, Quality Care/Health Services Research in S100bc. Dr. Erika Hamilton and Elisa Fontana, MD, PhD, SCRI at HCA Healthcare UK, also serve on the ASCO Annual Meeting Scientific Program Committee; Dr. Hamilton as the Prior Annual Meeting Scientific Committee Chair and Dr. Fontana on the Gastrointestinal Cancer – Colorectal & Anal Committee. In addition to scientific presentations, SCRI leadership will participate in and lead several ASCO sessions, including: Stephen Strickland, Jr., MD, MSCI, SCRI , will offer the “ Transplant Specialist Perspective ” during the session, From Myelodysplastic Syndrome to Acute Myeloid Leukemia: Treatment-Related Myeloid Neoplasm Diagnosis and Therapeutic Strategies on Saturday, May 30 from 8:00 a.m. – 9:00 a.m. CDT in E450b. Howard Burris, III, MD, SCRI , will deliver the “ Top Donor Recognition Ceremony ” during the Opening Session on Saturday, May 30 from 11:15 a.m. – 11:25 a.m. CDT in Hall B1. Dr. Melissa Johnson will present “ KRAS-Directed Therapy: A Clinical Update ” during the ASCO/AACR Joint Session: The KRAS Journey – Perseverance Pays Off on Saturday, May 30 from 1:34 p.m. – 1:49 p.m. CDT in S100bc. Debra Patt, MD, PhD, MBA, SCRI at Texas Oncology | The US Oncology Network , will present “ Algorithms in Action: From Training to Practice ” during the session, Oncology 2.0: How Artificial Intelligence Is Closing the Information Gap - Or Is It? on Sunday, May 31 from 10:45 a.m. – 10:57 a.m. CDT in S102. Dr. Elisa Fontana will present “ RAS in Colorectal Cancer: Mechanisms of Action, Inhibition and Resistance ” during the session, Emerging and Established Targets in Colorectal Cancer: Translating Biology in Therapeutics, as well as moderate the panel Q&A, on Sunday, May 31 from 4:30 p.m. – 4:45 p.m. CDT in Hall D2. Benjamin Garmezy, MD, SCRI , will chair the session, Rapid Oral: Genitourinary Cancer - Kidney and Bladder on Monday, June 1 at 8:00 a.m. – 9:30 a.m. CDT in Hall D2. Dr. Erika Hamilton will serve as Chair for the session, Highlights of the Year II on Monday, June 1 at 8:00 a.m. – 9:15 a.m. CDT in Hall D1. Dee Anna Smith, SCRI , will deliver “ The Community Frontline: Scaling Rapid Activation for Real-World Impact ” during the session, Time to Activation in Oncology Clinical Trials: Challenges and Opportunities for Improvement on Monday, June 1 from 8:40 a.m. – 8:55 a.m. CDT in S100a. Additional SCRI First-Author Poster Presentations Saturday, May 30, 2026 “ Advancing Health Equity in Oncology: Virtual Collaborative Behavioral Health Engagement and Outcomes Among Medicaid-Insured and BIPOC Patients,” Nina Balanchivadze, MD, SCRI at Virginia Oncology Associates | The US Oncology Network , 9:00 a.m. – 12:00 p.m. CDT, Hall A. “ Phase 1 Dose Escalation of CTX-8371, a Novel PD-1xPD-L1 Bispecific Antibody, in Patients with Advanced Malignancies Post Checkpoint Inhibition ,” Judy Wang, MD, SCRI at Florida Cancer Specialists & Research Institute | The US Oncology Network , 1:30 p.m. – 4:30 p.m. CDT, Hall A. “ BI-1808 + Pembrolizumab: Responses to a Chemotherapy-Free Regimen in Advanced Ovarian Cancer ,” Anja Williams, MD, SCRI at HCA Healthcare UK , 1:30 p.m. – 4:30 p.m. CDT, Hall A. Sunday, May 31, 2026 “ Real-World Characteristics, Homologous Recombination Repair Mutation Testing, Treatment Patterns, and Outcomes of Patients with Metastatic Castration-Sensitive Prostate Cancer in the US Community Oncology Setting ,” Manojkumar Bupathi, MD, MS, SCRI at Rocky Mountain Cancer Centers | The US Oncology Network , 9:00 a.m. – 12:00 p.m. CDT, Hall A. “ Combining HC-7366 with Belzutifan in Patients with Renal Cell Carcinoma to Alter Tumor and Microenvironment: Pharmacokinetic and Pharmacodynamic Analysis of a Phase 1b Study ,” Dr. Benjamin Garmezy , 9:00 a.m. – 12:00 p.m. CDT, Hall A. “ Imneskibart + Low-Dose Subcutaneous IL-2 ± Nivolumab in Patients with CPI-Refractory Cutaneous Melanoma: Promising Results from an Ongoing Phase 1/2 Study ,” Dr. Meredith McKean, 9:00 a.m. – 12:00 p.m. CDT, Hall A. “ Efficacy, Safety, and Cytokine Profiling with Addition of the Toll-Like Receptor 7/8 Dual Agonist EIK1001 to Standard of Care First-Line Therapy: The Phase 2 TeLuRide-005 Trial in Stage 4 NSCLC ,” Bo Wang, MD, SCRI at Willamette Valley Cancer Institute and Research Center | The US Oncology Network , 9:00 a.m. – 12:00 p.m. CDT, Hall A. Monday, June 1, 2026 “ Evaluating the Impact of a Statewide Intervention on Multiple Myeloma Bispecific T-Cell Engaging Antibody Therapy Uptake in Florida ,” Maen Hussein, MD, SCRI at Florida Cancer Specialists & Research Institute | The US Oncology Network , 9:00 a.m. – 12:00 p.m. CDT, Hall A. “ Comparative Efficacy of Linvoseltamab versus Teclistamab in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma: Updated Matching-Adjusted Indirect Comparison with Longer Follow-Up ,” Dr. Hans Lee , 9:00 a.m. – 12:00 p.m. CDT, Hall A. “ Efficacy Prediction for Progression-Free Survival and Overall Survival by Genomic Instability Score Cutoffs in Patients with Advanced Ovarian Cancer: Post Hoc Results from the Phase 3 PRIMA/ENGOT-OV26/GOG-3012 Trial ,” Bradley Monk, MD, SCRI at Florida Cancer Specialists & Research Institute | The US Oncology Network , 9:00 a.m. – 12:00 p.m. CDT, Hall A. “ A Phase 1/2, First-in-Human Study of AVZO-021, a Selective Cyclin-Dependent Kinase 2 Inhibitor, as Monotherapy and in Combination for Patients with Advanced Solid Tumors, including Hormone Receptor–Positive/Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer and Cyclin E1–Amplified Solid Tumors: Updated Safety and Efficacy Results ,” Manish R. Patel, MD, SCRI at Florida Cancer Specialists & Research Institute | The US Oncology Network , 1:30 p.m. – 4:30 p.m. CDT, Hall A. About Sarah Cannon Research Institute (SCRI) Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. It has conducted more than 900 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together approximately 1,500 oncology physicians who provide access to clinical trials in SCRI’s research network of over 200 locations in more than 20 states across the U.S. Visit SCRI.com to learn more . Contacts Becca Gelman Becca.Gelman@SCRI.com

-- Announced nomination of OKI-355, a next-generation PI3Kα pan-mutant selective inhibitor candidate, in vascular anomalies -- Initiated a discovery research program to expand the company’s pipeline in vascular anomalies -- Announced nomination of OKI-345, a next generation PI3Kα pan-mutant selective inhibitor candidate, in breast cancer -- Closed $150 million private placement to advance next-generation PI3Kα pan-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. “During the first quarter, we sharpened our strategic focus on advancing our next generation PI3Kα pan-mutant selective inhibitor programs, which we believe represent the most compelling opportunity to deliver differentiated therapies across PI3Kα-driven diseases,” said Nicholas Saccomano, Ph.D., President and Chief Executive Officer of OnKure. “Building 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 PI3Kα biology into programs with the potential to deliver meaningful, differentiated, and durable benefit to patients.” Vascular Anomalies OnKure recently announced the selection of OKI-355, an advanced next-generation PI3Kα pan-mutant selective inhibitor candidate, to lead its development pipeline in vascular anomalies. OKI-355 has been designed to selectively inhibit mutant PI3Kα while sparing wildtype PI3Kα, potentially enabling a wider therapeutic index and avoidance of class-limiting toxicities. High and sustained target coverage across all hotspot PI3Kα mutations can support the potential for deep and durable responses in vascular anomalies. Additionally, the Company initiated a discovery research program to expand OnKure’s pipeline in vascular anomalies. OnKure plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for OKI‑355 in the first half of 2027. Breast Cancer OnKure recently announced the selection of OKI-345, an advanced next-generation PI3Kα pan-mutant selective inhibitor candidate in breast cancer. Like OKI-355, OKI-345 has been designed to selectively inhibit mutant PI3Kα while sparing wildtype PI3Kα, potentially enabling a wider therapeutic index and avoidance of class-limiting toxicities. High and sustained target coverage across all hotspot PI3Kα mutations can support the potential for deep and durable responses in breast cancer, both as monotherapy and in combination. OnKure plans to submit an IND application to the FDA for OKI‑345 in the first half of 2027. Given the Company’s strategic focus on advancing its next-generation PI3Kα pan-mutant inhibitors, OnKure is not planning to independently pursue further clinical development of OKI-219, a highly selective PI3Kα H1047 mutant-specific inhibitor, at this time. The Company plans to report data from PIKture-01 by the end of 2026. Additional information about PIKture-01 may be found at , using Identifier: NCT06239467. Upcoming Conference 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. Financial Results Cash and cash equivalents were $192.1 million as of March 31, 2026, including proceeds from the oversubscribed $150 million private placement, which closed on March 31, 2026. Research and development (R&D) expenses 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. General and Administrative (G&A) expenses 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. Net loss and net loss per share 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. About the PIKture-01 Study 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. 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’s PI3Kα pan-mutant inhibitors, OnKure is not planning to pursue further clinical development of OKI-219 independently at this time. Additional information about PIKture-01 may be found at , using Identifier: NCT06239467. About OnKure Therapeutics 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 selectively target specific mutations thought to be key drivers of vascular anomalies and cancer. OnKure aims to become a leader in targeting PI3Kα and has multiple programs designed to enable best-in-class targeting of this key oncogene. For more information about OnKure, visit us at and follow us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements 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’s product candidates and programs, including OKI-355 and OKI-345; OnKure’s ability to advance additional programs; 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’s expected cash runway; and statements by OnKure’s President and Chief Executive Officer. In some cases, you can identify forward-looking statements by terminology such as “expect,” “estimate,” “intend,” “may,” “plan,” “potentially,” “will” or the negative of these terms or other similar expressions. These forward-looking statements are based largely on OnKure’s 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’s 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’s 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’s product candidates; the outcome of preclinical testing and early clinical trials for OnKure’s 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’s 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’s current or future product candidates in combination with other therapies and the cost of combination therapies; OnKure’s 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’s ability to protect its intellectual property and proprietary technologies; developments relating to OnKure’s 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 “Risk Factors” 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’s management to predict all risk factors, nor can OnKure assess the impact of all factors on OnKure’s 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. Contact: Dan Ferry LifeSci Advisors daniel@lifesciadvisors.com ONKURE THERAPEUTICS, INC. Condensed Consolidated Balance Sheets (In thousands, unaudited) March 31, 2026 December 31, 2025 Assets Current assets: Cash and cash equivalents $ 192,106 $ 59,050 Prepaid expenses and other current assets 5,376 1,789 Total current assets 197,482 60,839 Property and equipment, net 519 618 Operating lease, right-of-use asset 288 387 Other assets 405 273 Total assets $ 198,694 $ 62,117 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable, accrued expenses, and other liabilities $ 13,920 $ 5,372 Operating lease liabilities, current portion 409 549 Total current liabilities 14,329 5,921 Long-term liabilities 12 12 Total liabilities 14,341 5,933 Stockholders’ equity 184,353 56,184 Total liabilities and stockholders’ equity $ 198,694 $ 62,117 ONKURE THERAPEUTICS, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share data, unaudited) Three Months Ended March 31, 2026 2025 Operating expenses: Research and development $ 11,707 $ 13,012 General and administrative 3,908 3,988 Total operating expenses 15,615 17,000 Loss from operations (15,615) (17,000) Other income: Interest income 458 1,075 Net loss and comprehensive loss $ (15,157) $ (15,925) Net loss per share attributable to common stockholders: Basic and diluted $ (1.11) $ (1.19) Weighted average shares outstanding: Basic and diluted 13,674,577 13,424,335