Summit Therapeutics Inc (SMMT)

Ivonescimab with Chemotherapy Demonstrated a Statistically Significant Overall Survival Benefit Compared to Tislelizumab Plus Chemotherapy in 1L Treatment of Patients with Squamous NSCLC in the HARMONi-6 Study Conducted by Akeso in ChinaMay 31, 2026 9:06 AM
Business Wire Ivonescimab Plus Chemotherapy Reduced the Risk of Death by 34% Compared to Tislelizumab Plus Chemotherapy; Hazard Ratio 0.66 First Regimen to Achieve a Statistically Significant and Clinically Meaningful Overall Survival Benefit over an anti-PD-(L)1 Antibody Combined with Chemotherapy in a Phase III Clinical Trial in 1L NSCLC Tolerable Safety Profile Consistent with Prior Clinical Trial Results Simultaneous Publication of Latest Ivonescimab HARMONi-6 Results in The Lancet Summit Conference Call to Be Held at 7:00 a.m. ET on Monday, June 1, 2026 Summit Therapeutics Inc. (NASDAQ: SMMT) today announced positive overall survival (OS) results from the Phase III HARMONi-6 trial, conducted in China and sponsored by Summit’s partner Akeso, Inc. (HKEX Code: 9926.HK), will be presented today as part of the Plenary Session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The presentation is entitled “Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy in previously untreated advanced squamous non-small cell lung cancer: Overall survival results of the phase 3 HARMONi-6 trial.” HARMONi-6 is evaluating ivonescimab in combination with platinum-based chemotherapy compared to tislelizumab, a PD-1 inhibitor, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) irrespective of PD-L1 expression. HARMONi-6 is a single region, multi-center, Phase III study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso. The trial’s primary endpoint is progression-free survival (PFS), and OS is a key secondary endpoint. The trial results will be presented by Dr. Shun Lu, MD, PhD, Chief of Shanghai Lung Cancer Center at Shanghai Chest Hospital, Professor of Medicine at Shanghai Jiaotong University, and associate editor for the Journal of Thoracic Oncology. In major markets globally, first-line therapy for patients with advanced NSCLC without driver mutations is most commonly a PD-1 inhibitor plus platinum-based chemotherapy. Prior to HARMONi-6, there were no known Phase III clinical trials in advanced NSCLC which have shown a statistically significant and clinically meaningful improvement in OS when compared to PD-(L)1 inhibitor therapy in combination with chemotherapy in a head-to-head setting. Examples of PD-(L)1 inhibitors include pembrolizumab, nivolumab, tislelizumab, and atezolizumab. Clinically Meaningful Efficacy In the HARMONi-6 planned interim analysis of OS, ivonescimab in combination with chemotherapy demonstrated a statistically significant improvement when compared to tislelizumab in combination with chemotherapy, with a hazard ratio (HR) of 0.66 (95% CI: 0.50, 0.87; p=0.0017). A clinically meaningful benefit was demonstrated across clinical subgroups, including those with either PD-L1 negative or positive expression. OS rates at 24 months were 64.7% for those patients receiving ivonescimab plus chemotherapy compared to 48.6% for those receiving tislelizumab plus chemotherapy. Median follow-up time of the current data cut was 21.4 months. HARMONi-6 ITT (n=532): Median Follow-up: 21.36 mos. Ivonescimab + Chemo (n=266) Tislelizumab + Chemo (n=266) Median OS 27.89 mos. (95% CI: 27.89, NE) 23.69 mos. (95% CI: 20.11, NE) 24-Month OS Rates 64.7% 48.6% OS Stratified HR 0.66 (95% CI: 0.50, 0.87; p= 0.0017) mos.: months; NE: not established HARMONi-6 PD-L1 Subgroup Analyses Ivonescimab + Chemo vs. Tislelizumab + Chemo PD-L1 Negative (PD-L1 TPS 1%) OS stratified HR Ivonescimab + Chemo n=161; Tislelizumab + Chemo n=161 0.68 (95% CI: 0.46, 0.99) “For the first time, a Phase III clinical study has demonstrated a statistically significant overall survival benefit in front-line driver-mutation-negative non-small cell lung cancer compared to anti-PD-1 therapy in combination with chemotherapy,” said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit. “While this represents another study where ivonescimab has demonstrated a significant OS benefit, these data represent the answer to the question regarding ivonescimab and its ability to translate PFS benefits into the extension of lives for patients with cancer in the front-line setting compared to immunotherapy-based regimens.” The HARMONi-6 study met its primary endpoint as announced in April 2025, showing a statistically significant and clinically meaningful improvement in PFS. Detailed results for efficacy and safety were presented at the European Society of Medical Oncology 2025 Congress (ESMO 2025) last October and published in The Lancet simultaneously. Safety Profile In this analysis, ivonescimab continued to demonstrate an acceptable and manageable safety profile in the HARMONi-6 study, which was consistent with previous Phase III studies of ivonescimab plus chemotherapy. No additional safety signals were noted in the HARMONi-6 study in this current data cut compared to the previous data cut presented. Treatment-related serious adverse events occurred in 41.4% of patients receiving ivonescimab in combination with chemotherapy and 34.3% of patients receiving tislelizumab in combination with chemotherapy. Most of the possibly VEGF-related adverse events occurring in the ivonescimab-plus-chemotherapy arm were classified as Grade 1 or 2; Grade 3 or higher hemorrhage events were observed in 2.6% of patients in the ivonescimab-plus-chemotherapy arm compared to 0.8% of patients in the tislelizumab-plus-chemotherapy arm in this study. Treatment-related adverse events (TRAEs) leading to discontinuation in this study occurred in 5.3% of patients receiving ivonescimab plus chemotherapy compared to 4.5% for those receiving tislelizumab plus chemotherapy. In squamous NSCLC, VEGF-A monoclonal antibodies have had limited clinical development based on historical data demonstrating significant risks of toxicity, including life-threatening hemorrhage and other bleeding complications. The results of this study further validate the unique mechanism of action of ivonescimab, including apparent key differences as compared to historical clinical studies where an anti-PD-1 monoclonal antibody and an anti-VEGF monoclonal antibody were administered separately. HARMONi-6 Clinical Trial Results Published in The Lancet The Lancet simultaneously published these findings in a manuscript titled, “Ivonescimab plus Chemotherapy for Squamous Non-small-cell Lung Cancer.” “A heartfelt congratulations to our partner, Akeso, for their continuing, tremendous efforts to make a significant difference in the lives of patients with cancer,” said Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit. “The decision we made in December 2022 to enter into a partnership specifically with Akeso and accelerate the global clinical development plan of this potentially landscape-changing compound in ivonescimab is further validated with these groundbreaking results for patients facing high unmet medical needs. We look forward to continuing this positive momentum.” Conference Call Summit will host a conference call and live webcast to discuss recent updates related to ivonescimab, including data released at ASCO, on Monday, June 1, 2026, at 7:00 a.m. ET. Conference call and webcast information is accessible through the company’s website, www.smmttx.com. An archived edition of the webcast will be available on the website later in the day on Monday. About Ivonescimab
Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF. This is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Summit believes ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets. Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 70,000 patients when considering those treated in a commercial setting in China, as noted by Akeso. There are currently 15 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, four of which are Summit-sponsored global studies, one of which is a multiregional study sponsored by a cooperative group, and 10 of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, Summit began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into CRC in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3. HARMONi is a Phase III clinical trial is evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026. HARMONi-3 is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression. The clinical trial is evaluating the two histologies as individual, separately powered cohorts with independent statistical powering. HARMONi-7 is a Phase III clinical trial evaluating ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC. ILLUMINE is a Phase III study being conducted by GORTEC, a cooperative group dedicated to Head and Neck Oncology, in recurrent / metastatic head and neck squamous cell carcinoma (r/m HNSCC). ILLUMINE is a three-arm Phase III clinical trial designed to evaluate ivonescimab monotherapy, as well as ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, compared to monotherapy pembrolizumab in patients with PD-L1 positive r/m HNSCC. In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in both the HARMONi-A and HARMONi-6 studies, and a manageable safety profile in each study. HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI. HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression. Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024. About Summit Therapeutics Inc.
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. Summit was founded in 2003 and the company’s shares are listed on the Nasdaq Global Market (symbol "SMMT"). Summit is headquartered in Miami, Florida, with additional offices in Palo Alto, California, Princeton, New Jersey, Dublin, Ireland, and Oxford, UK. For more information, please visit https://www.smmttx.com and follow Summit on X @SMMT_TX. Summit Forward-Looking Statements
Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc. and other collaborations, the intended use of the net proceeds from the private placements, the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the expected timing of BLA submissions or FDA decisions, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected proceeds and uses thereof, the Company’s estimates regarding stock-based compensation, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the effects of geopolitical developments, domestic and foreign trade policies, and monetary policies, the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of filings that the Company makes with the Securities and Exchange Commission. Summit defines a “positive study” as a clinical study that with one or more prespecified primary endpoints in which one of those endpoints achieves a statistically significant benefit according to the protocol or statistical analysis plan. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release. Summit Therapeutics and the Summit Therapeutics logo are registered trademarks of Summit Therapeutics Inc. and/or its affiliates. Copyright 2026, Summit Therapeutics Inc. All Rights Reserved. View source version on businesswire.com: https://www.businesswire.com/news/home/20260531161413/en/ Summit Investor Relations & Media Contacts:
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media@smmttx.com Original: Ivonescimab with Chemotherapy Demonstrated a Statistically Significant Overall Survival Benefit Compared to Tislelizumab Plus Chemotherapy in 1L Treatment of Patients with Squamous NSCLC in the HARMONi-6 Study Conducted by Akeso in China

Encouraging Global Phase II Ivonescimab Data in First-Line Metastatic Colorectal Cancer Presented at ASCO 2026May 30, 2026 8:00 AM
Business Wire Promising Data Further Support Continued Expansion of Ivonescimab Clinical Development in mCRC Overall Study Population Achieved ORR of 70.8% and DCR of 100.0%; Responses Consistent Across Ivonescimab Dose Levels Combined with Chemotherapy Acceptable and Manageable Safety Profile for Ivonescimab Regimen; No New Safety Signals Observed Summit Therapeutics Inc. (NASDAQ: SMMT) today presented new results from the AK112-206 trial (NCT05382442), a global, open-label, multicenter Phase II study in first-line metastatic colorectal cancer (mCRC) co-sponsored by Summit and Akeso, featuring the novel, potential first-in-class investigational bispecific antibody ivonescimab. The data were presented today at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The presentation, entitled “Ivonescimab with Oxaliplatin + Fluorouracil + Leucovorin Calcium for Patients with Unresectable Metastatic Colorectal Cancer: A Phase 2 Study,” detailed interim results of the multiregional extension portion of the study evaluating ivonescimab combined with mFOLFOX6 chemotherapy in patients with unresectable microsatellite stable (MSS) mCRC who were previously untreated for metastatic disease. Patients (n=49) were randomized (1:1) to receive ivonescimab (10 or 20 mg/kg; n=24, n=25, respectively) plus mFOLFOX6 once every two weeks. The data cut-off for this analysis was March 31, 2026 (10 or 20 mg/kg median follow-up: 9.9 months, 9.8 months, respectively). In this U.S.- and China-based Phase II cohort of treatment-naïve patients with mCRC, patients receiving ivonescimab in combination with standard-of-care doublet chemotherapy mFOLFOX6 demonstrated an objective response rate (ORR) of 70.8% across both arms in evaluable patients (n=48). This result is encouraging compared to historical performance of standard-of-care regimens combining bevacizumab with FOLFOX chemotherapy from prior studies. Treatment responses in the ivonescimab 20 mg/kg arm were more durable than in the ivonescimab 10 mg/kg arm, with a duration of response landmark estimate at 9 months of 79.1% vs. 41.5%, respectively. While progression-free survival (PFS) analysis is still immature in this study, the landmark 9-month PFS rate was 76.1% for those patients receiving 20 mg/kg of ivonescimab. The safety profile of ivonescimab combined with chemotherapy in this study is comparable to rates observed in historical studies with chemotherapy and anti-VEGF antibodies. In total including both arms, 20.4% of patients experienced serious treatment-related adverse events (TRAEs) associated with either ivonescimab or chemotherapy. There were no ivonescimab-related deaths and one ivonescimab-related discontinuation, supporting the tolerability and ability to manage adverse events. “In this expansion cohort of treatment-naïve patients with metastatic colorectal cancer, the addition of ivonescimab to mFOLFOX6 delivered deep and durable response rates that compare favorably to historical benchmarks seen with chemotherapy alone or in combination with anti-VEGF therapies,” said David Berz, M.D., Ph.D., medical oncologist, Founder of Valkyrie Clinical Trials and an investigator in the AK112-206 study. “While progression-free survival remains immature, the high proportion of patients who were progression-free at nine months is encouraging, and the safety profile was consistent with established standards of care. These results support the potential of this dual-targeted approach to improve outcomes in this difficult-to-treat population and warrant further investigation.” Ivonescimab continues to demonstrate an acceptable and manageable safety profile with no new safety signals observed in this study. This was consistent with previous studies of ivonescimab, including Phase II data in mCRC, and evidencing the potential for a favorable benefit-risk profile for ivonescimab plus mFOLFOX6 in this setting. In this study, adverse events were manageable: all patients experienced at least one treatment-emergent adverse event (TEAE) related to either ivonescimab or chemotherapy with the most common events on both dosing arms being decreased neutrophil count, decreased white blood cell count, and anemia. “Metastatic colorectal cancer remains a significant area of unmet need, where many patients continue to face limited durable treatment options,” said Allen S. Yang, M.D., Ph.D., Chief R&D Strategy Officer of Summit. “These data add to the growing body of evidence supporting the potential of ivonescimab as a differentiated PD-1 / VEGF bispecific, and we are committed to advancing its development across multiple tumor types where we believe it may meaningfully improve patient outcomes.” Summit is currently conducting HARMONi-GI3 (NCT07228832), a global Phase III clinical trial evaluating ivonescimab in combination with mFOLFOX6 chemotherapy compared with bevacizumab plus mFOLFOX6 chemotherapy in patients with first-line unresectable mCRC. This study is featured at this year’s ASCO Annual Meeting in a Trials-in-Progress (TiP) presentation entitled, “A Randomized, Active-Controlled Phase 3 Study of Ivonescimab + FOLFOX Versus Bevacizumab + FOLFOX as First-Line Treatment of Metastatic Colorectal Cancer: HARMONi-GI3.” About Colorectal Cancer
Colorectal cancer (CRC), which includes cancers of the colon and rectum, is the third most commonly diagnosed cancer worldwide and the second leading cause of cancer-related death, with approximately 1.9 million new cases and more than 900,000 deaths reported globally in 2022.1 In the U.S., CRC remains a significant health burden, with an estimated 158,850 new cases and 55,230 deaths projected in 2026.2 Prognosis is highly dependent on stage at diagnosis: while overall 5-year survival is approximately 65%, patients with metastatic disease have substantially poorer outcomes, with 5-year survival rates of approximately 13% for metastatic colon cancer and 18% for metastatic rectal cancer.2,3 These data underscore the urgent need for improved treatment options for patients with metastatic CRC (mCRC). CRC is biologically heterogeneous, with tumors broadly classified based on microsatellite status. Approximately 80–85% of colorectal cancers are microsatellite stable (MSS), also referred to as mismatch repair–proficient (pMMR) tumors.4 MSS/pMMR colorectal tumors are typically characterized by lower tumor mutational burden and an immune-cold phenotype, with limited responsiveness to immune checkpoint inhibitors.5,6 In metastatic disease, they represent the overwhelming majority of cases, accounting for approximately 95% of tumors.5 As a result, most patients with mCRC are not eligible for currently approved immunotherapy monotherapies and are treated with chemotherapy-based regimens, often in combination with targeted therapies such as anti-VEGF and anti-EGFR agents. About Ivonescimab
Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF. This is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Summit believes ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets. Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 70,000 patients when considering those treated in a commercial setting in China, as noted by Akeso. There are currently 15 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, four of which are Summit-sponsored global studies, one of which is a multiregional study sponsored by a cooperative group, and 10 of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, Summit began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into CRC in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3. HARMONi is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third- generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026. HARMONi-3 is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression. The clinical trial is evaluating the two histologies as individual, separately powered cohorts with independent statistical powering. HARMONi-7 is a Phase III clinical trial evaluating ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC. ILLUMINE is a Phase III study being conducted by GORTEC, a cooperative group dedicated to Head and Neck Oncology, in recurrent / metastatic head and neck squamous cell carcinoma (r/m HNSCC). ILLUMINE is a three-arm Phase III clinical trial designed to evaluate ivonescimab monotherapy, as well as ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, compared to monotherapy pembrolizumab in patients with PD-L1 positive r/m HNSCC. In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in HARMONi-A, with a manageable safety profile in each study. HARMONi-A was a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI. HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression. Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024. About Summit Therapeutics Inc.
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. Summit was founded in 2003 and the company’s shares are listed on the Nasdaq Global Market (symbol "SMMT"). Summit is headquartered in Miami, Florida, with additional offices in Palo Alto, California, Princeton, New Jersey, Dublin, Ireland, and Oxford, UK. For more information, please visit https://www.smmttx.com and follow Summit on X @SMMT_TX. References: World Health Organization. Colorectal cancer fact sheet. February 13, 2026. Accessed May 19, 2026. National Cancer Institute, Surveillance, Epidemiology, and End Results (SEER) Program. Cancer Stat Facts: Colorectal Cancer. Accessed May 19, 2026. American Cancer Society. Survival Rates for Colorectal Cancer (based on SEER 2014–2020 data). January 13, 2026. Accessed May 19, 2026. Colorectal Cancer Alliance. Microsatellite Stability Biomarker (MSS). Accessed May 19, 2026. Lieu CH. The use of immunotherapy in metastatic microsatellite-stable colorectal cancer. Hematol Oncol. 2022;20(12). Han YJ, Shao CY, Yao Y, et al. Immunotherapy of microsatellite stable colorectal cancer: resistance mechanisms and treatment strategies. Postgrad Med J. 2024;100:373–381. Summit Forward-Looking Statements
Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc. and other collaborations, the intended use of the net proceeds from the private placements, the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the expected timing of BLA submissions or FDA decisions, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected proceeds and uses thereof, the Company’s estimates regarding stock-based compensation, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the effects of geopolitical developments, domestic and foreign trade policies, and monetary policies, the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of filings that the Company makes with the Securities and Exchange Commission. Summit defines a “positive study” as a clinical study that with one or more prespecified primary endpoints in which one of those endpoints achieves a statistically significant benefit according to the protocol or statistical analysis plan. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release. Summit Therapeutics and the Summit Therapeutics logo are registered trademarks of Summit Therapeutics Inc. and/or its affiliates. Copyright 2026, Summit Therapeutics Inc. All Rights Reserved. View source version on businesswire.com: https://www.businesswire.com/news/home/20260530544179/en/ Summit Investor Relations & Media Contacts:
Nathan LiaBraaten
Senior Director, Investor Relations Tracy Jones
Director, Media & Public Relations investors@smmttx.com
media@smmttx.com Original: Encouraging Global Phase II Ivonescimab Data in First-Line Metastatic Colorectal Cancer Presented at ASCO 2026

B7-H3 Becomes The Hottest Antigen In Oncology, And One NK Engager Enters ClinicMay 18, 2026 2:22 PM
PR Newswire (US) Issued on behalf of GT Biopharma, Inc. SAN FRANCISCO, May 18, 2026 /PRNewswire/ -- USA News Group News Commentary — For more than two decades, B7-H3 sat on the shortlist of theoretically perfect cancer drug targets that nobody could quite figure out how to hit. The protein is broadly overexpressed across some of the most common — and most lethal — solid tumors, including prostate, lung, breast, ovarian, head and neck, and pancreatic cancers. It is largely absent from healthy tissue. It correlates with poor prognosis. On paper, it has every quality a drug developer wants. In practice, three B7-H3-targeting antibody-drug conjugates have entered the clinic, and none have yet been approved.[1] That is starting to change. Key Takeaways GT Biopharma (NASDAQ: GTBP) dosed the first patient on May 14, 2026 in a Phase 1 dose-escalation basket trial of GTB-5550, its B7-H3-targeted natural killer cell engager for solid tumors expressing B7-H3 — the third TriKE candidate to enter the clinic, and the first tested with patient-friendly subcutaneous dosing.FDA cleared the GTB-5550 IND in February 2026, with dose-escalation cohorts prioritizing advanced prostate, ovarian, and pancreatic cancer patients who have failed prior therapy. The Company targets a portion of the estimated US$362 billion global solid tumor market.B7-H3 has rapidly become one of the most actively pursued antigens in solid tumor oncology in 2026, with bispecific antibody-drug conjugates, systemic radiopharmaceuticals, and now natural killer cell engagers all converging on the same target — broadly overexpressed across prostate, lung, breast, ovarian, head and neck, and pancreatic cancers, largely absent from healthy tissue.GT Biopharma reported a cash balance as of March 31, 2026 of approximately US$9 million, anticipated to provide sufficient cash runway through Q4 2026, with Phase 1 updates anticipated in 2H 2026 as dose escalation progresses.In 2026, B7-H3 has become one of the most actively pursued antigens in solid tumor oncology. The mechanisms are widely varied — bispecific antibody-drug conjugates at IDEAYA, antibody-drug conjugates at GSK paired with bispecific antibody combinations at Summit Therapeutics, systemic radiopharmaceuticals across other pipelines, and now a natural killer cell engager from GT Biopharma, Inc. (NASDAQ: GTBP) — but the target is the same. The convergence is what makes the moment distinctive. When mechanism diversity collapses onto a single antigen, the antigen is what is being repriced.Read more on GT Biopharma by clicking here GTB-5550: The Third TriKE Into The Clinic, And The First Subcutaneous On May 14, 2026, GT Biopharma announced that the first patient had been dosed in a Phase 1 dose-escalation basket trial evaluating GTB-5550, its B7-H3-targeted natural killer cell engager for solid tumors expressing B7-H3.[2] GTB-5550 is the third TriKE — Tri-specific Killer Engager — molecule from GT Biopharma to enter the clinic. Critically, it is also the first to be tested with subcutaneous dosing, a design choice that distinguishes it from a category where most engager therapies have historically required continuous infusion.[1]"Dosing the first patient in our GTB-5550 Phase 1 trial is a pivotal milestone for GT Biopharma and represents the natural evolution of our TriKE platform into the broader opportunity of treating patients with a variety of solid tumors," said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma.[1] The May 15, 2026 Q1 financial results release confirmed the broader pipeline context: with the GTB-5550 Phase 1 trial now active, GT Biopharma has advanced three TriKE candidates into the clinic — a milestone Breen described as one that "underscores the continued momentum of our pipeline."[3]The molecular architecture of GTB-5550 reflects the design discipline GT Biopharma has built into its 2nd-generation TriKE platform. The molecule is a camelid (cam) anti-CD16 / WT IL-15 / cam anti-B7-H3 tri-specific natural killer cell engager — a single-chain recombinant TriKE comprised of three components joined by flexible linkers: a nanobody arm that engages the CD16 activating receptor on natural killer cells, a wildtype IL-15 linker arm to drive NK cell proliferation, priming, and survival, and a nanobody arm that specifically engages B7-H3 to target the antigen expressed on tumor cells.[4] The 2nd-generation TriKE platform that underlies GTB-5550 has been described as 10–40 times more potent than 1st-generation TriKE, and all current TriKE development at the Company is focused on the 2nd-generation platform.[4]Dose Escalation: Prostate, Ovarian, And Pancreatic Cancer Prioritized FDA cleared the GTB-5550 IND application in February 2026.[5] In the Company's commentary on the clearance, Breen described it as "a defining moment for GT Biopharma as we bring another NK cell engager into the clinic."[5] The Phase 1 trial is structured as a basket trial open to patients with common solid tumors that express B7-H3. In the dose-escalation component, enrollment is being prioritized for advanced prostate, ovarian, and pancreatic cancer patients who have failed prior therapy.[5] The clinical design reflects a deliberate choice: prioritize patient populations where the unmet need is highest, where B7-H3 expression is well-characterized, and where the regulatory pathway around accelerated approval has historically been most navigable.Phase 1 trial updates are anticipated in the second half of 2026 as enrollment progresses through dose escalation cohorts.[3] The Q1 2026 financial results release reported a cash balance as of March 31, 2026 of approximately US$9 million, anticipated to provide sufficient cash runway through Q4 2026.[3] The funding visibility, paired with the Phase 1 first-patient-dosed milestone, gives investors a defined catalyst window across the back half of 2026 for the first set of clinical readouts from the new program.The TriKE platform has been developed under an exclusive worldwide license agreement with the University of Minnesota, providing GT Biopharma with the rights to further develop and commercialize therapies using TriKE technology.[2] The Company's broader pipeline now spans GTB-3650 (the first 2nd-generation camelid nanobody TriKE, being tested clinically for CD33-positive leukemias including AML and MDS), GTB-5550 (the B7-H3 program for solid tumors), and GTB-7550 (in development for CD19-positive lymphoid malignancies and autoimmune disease).[4]Why The B7-H3 Convergence Matters The strategic case for GTB-5550 is sharpened by what is happening around B7-H3 across the rest of the oncology sector. The number of high-quality drug developers now actively pursuing the antigen, across multiple modalities, has shifted B7-H3 from "theoretically perfect" to "actively competitive" in less than 18 months. That competition matters less as a threat than as a validation. When IDEAYA is enrolling a bispecific B7-H3 / PTK7 antibody-drug conjugate, GSK is partnering its B7-H3 antibody-drug conjugate with Summit Therapeutics's ivonescimab in multiple solid tumor settings, and GT Biopharma is dosing the first patient in a B7-H3 NK cell engager Phase 1 trial — all within the first half of 2026 — the read-through is that the antigen has reached the threshold where the drug developer community has concluded the biology supports clinical translation.[1]What differentiates GT Biopharma inside that crowd is the mechanism. GTB-5550 is the only B7-H3-targeted natural killer cell engager in the Phase 1 patient-dosing window in 2026, and the only one tested with subcutaneous dosing. The TriKE design — engaging CD16 on NK cells, embedding an IL-15 moiety to drive NK cell proliferation and persistence, and targeting B7-H3 on tumor cells — gives the molecule a mechanistic profile that is structurally distinct from the antibody-drug conjugate and bispecific antibody approaches that dominate the rest of the B7-H3 development field.How GT Biopharma Sits Inside The B7-H3 And Solid Tumor Universe Summit Therapeutics Inc. (NASDAQ: SMMT) is one of the largest publicly traded oncology biotechs by market capitalization, with a market value around US$14 billion as of early 2026.[6] On January 12, 2026, Summit announced a clinical trial collaboration with GSK plc to evaluate ivonescimab — Summit's lead PD-1 / VEGF bispecific antibody — in combination with GSK's novel investigational B7-H3-targeting antibody-drug conjugate, risvutatug rezetecan (also known as GSK'227), across multiple solid tumor settings including small cell lung cancer.[7] Summit subsequently announced FDA acceptance of its Biologics License Application for ivonescimab on January 29, 2026, with a Prescription Drug User Fee Act goal action date of November 14, 2026.[8] Summit represents the institutional-scale comparable for the broader bispecific oncology investment thesis B7-H3 development is now inside.IDEAYA Biosciences, Inc. (NASDAQ: IDYA) announced in February 2026 that the first patient had been enrolled in its Phase 1 dose-escalation/expansion trial evaluating IDE034, a potential first-in-class PTK7 / B7-H3 bispecific TOP1 antibody-drug conjugate.[6] The design rationale is unusually specific: IDEAYA estimates that B7-H3 and PTK7 are co-expressed in approximately 30–40% of certain large solid tumor types — including lung, breast, ovarian, and colorectal cancers — while exhibiting minimal dual-antigen expression in normal tissue.[6] The drug is designed to be internalized only when both antigens are co-expressed on the same tumor cell, an architecture intended to enhance selectivity and tolerability compared to monovalent antibody formats.[6] IDEAYA offers the cleanest small-to-mid-cap B7-H3 development comparable in the public market.GSK plc (NYSE: GSK) is one of the largest pharmaceutical companies in the world by market cap, and the B7-H3-targeting antibody-drug conjugate risvutatug rezetecan (GSK'227) sits inside its broader oncology platform. The January 12, 2026 collaboration with Summit Therapeutics to combine GSK'227 with ivonescimab across multiple solid tumor settings, including small cell lung cancer, places GSK directly in the B7-H3 development conversation — and signals to the broader industry that one of the largest pharmaceutical companies in the world has concluded the B7-H3 modality is worth aggressive clinical investment.[7] GSK's involvement is a structural validation of the antigen that supports the broader investment thesis around B7-H3-targeted programs at every scale.Innate Pharma S.A. (NASDAQ: IPHA) has long been one of the more prominent publicly listed pure-play NK cell engager companies, with multispecific approaches that hit triggering receptors including NKp46 — adding to the broader CD16-anchored NK cell engagement framework. Innate's NK cell engager IPH6101 was advanced with Sanofi as a clinical-stage candidate for blood cancers. Innate provides a relevant comparable for the NK cell engager mechanism category specifically — distinct from the antibody-drug conjugate and bispecific antibody mechanisms that dominate most of the rest of the B7-H3 field — and helps frame the mechanism-specific investment thesis for an engager-platform company like GT Biopharma.Across all four comparables, the pattern is recognizable: 2026 is the year B7-H3 became one of the most-watched antigens in oncology, and the development pipelines now actively pursuing it span four different mechanism categories. GT Biopharma's distinction inside that crowd is that its TriKE platform is the only NK cell engager with a B7-H3 program currently dosing patients.The Catalyst Window Ahead The remainder of 2026 sets up a defined catalyst window for GT Biopharma. The Phase 1 dose-escalation trial for GTB-5550 is now enrolling, with the first patient dosed on May 14, 2026, and updates anticipated in 2H 2026 as the trial progresses through dose escalation cohorts.[3] The Company's cash position of approximately US$9 million as of March 31, 2026 is expected to provide sufficient runway through Q4 2026 — meaning the question of when initial efficacy or safety signals can be expected, and when additional capital may need to be raised against initial Phase 1 read, are both visible inside the next two to three quarters.[3]For investors who have read the B7-H3 convergence — and concluded that the antigen has reached the validation threshold where mechanism differentiation now matters — GT Biopharma offers a small-cap, single-platform exposure to the only NK cell engager program currently in B7-H3 patient dosing. Whether the Phase 1 data ultimately supports translation into a registrational program will be tested cohort by cohort across the back half of 2026 and into 2027. The window for new entrants into the B7-H3 antigen-targeted clinical field is no longer wide open — but the window for differentiated mechanisms inside it has, briefly, never been more visible.CONTACT:USA News Group
info @therooster-2873Article Sources[1] https://www.globenewswire.com/news-release/2026/05/14/3295057/0/en/A-Cancer-Antigen-Long-Thought-Untouchable-Is-Suddenly-the-Hottest-Target-in-Oncology.html [2] https://www.manilatimes.net/2026/05/14/tmt-newswire/globenewswire/gt-biopharma-announces-first-patient-dosed-in-phase-1-trial-of-gtb-5550-a-b7-h3-targeted-natural-killer-nk-cell-engager-for-solid-tumors/2343964 [3] https://www.biospace.com/press-releases/gt-biopharma-reports-first-quarter-2026-financial-results [4] https://www.gtbiopharma.com/product-pipeline/overview [5] https://www.globenewswire.com/news-release/2026/02/03/3231077/0/en/GT-Biopharma-Announces-FDA-Clearance-of-Investigational-New-Drug-IND-Application-for-GTB-5550-TriKE-a-B7-H3-Targeted-Natural-Killer-NK-Cell-Engager-for-Solid-Tumors-Expressing-B7-H.html [6] https://investingnews.com/a-cancer-antigen-long-thought-untouchable-is-suddenly-the-hottest-target-in-oncology/ [7] https://www.sec.gov/Archives/edgar/data/0001599298/000159929826000004/a2026_prx0112xannounceme.htm [8] https://www.sec.gov/Archives/edgar/data/0001599298/000159929826000006/smmt-20260129.htmDISCLAIMER NOTICEDISCLAIMER/DISCLOSURE:Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a digital media distribution and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). This article is being distributed by USA News Group on behalf of MIQ. MIQ has been paid a fee for GT Biopharma, Inc. advertising and digital media from Creative Direct Marketing Group ("CDMG"). There may be 3rd parties who may have shares of GT Biopharma, Inc. and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this article or email as the basis for any investment decision. The owner/operator of MIQ currently owns shares of GT Biopharma, Inc. that were purchased in the open market and reserves the right to buy and sell, and will buy and sell shares of GT Biopharma, Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company; no further notice will be given, but let this disclaimer serve as notice that all material disseminated by MIQ has been reviewed and approved on behalf of GT Biopharma, Inc. by CDMG; this is a digital media distribution.While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our article is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.Logo - https://mma.prnewswire.com/media/2838876/5656770/USA_News_Group_Logo.jpg View original content to download multimedia:https://www.prnewswire.com/news-releases/b7-h3-becomes-the-hottest-antigen-in-oncology-and-one-nk-engager-enters-clinic-302775099.htmlSOURCE USA News Group Original: B7-H3 Becomes The Hottest Antigen In Oncology, And One NK Engager Enters Clinic

Multiple Ivonescimab Data Sets from Phase III Studies in Advanced NSCLC Patient Populations to be Featured at ELCC 2026March 27, 2026 8:15 AM
Business Wire
Three Poster Presentations Will Feature Updated Ivonescimab Data, including Intracranial Anti-Tumor Activity from the Global HARMONi Phase III Study


Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented at the 2026 European Lung Cancer Congress (ELCC 2026) in Copenhagen, Denmark. Three posters featuring updated ivonescimab data will be displayed on Friday, March 27 from 1:00 to 2:00 pm Central European Time. Data for HARMONi was generated and analyzed by Summit and for HARMONi-2 by our collaboration and licensing partner, Akeso Inc. (HKEX Code: 9926.HK).


The first poster, “Intracranial Efficacy of Ivonescimab Plus Chemotherapy in Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI)-Resistant, EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) in the HARMONi Study” includes outcome data from patients with and without asymptomatic brain metastases at baseline enrolled in HARMONi (NCT06396065). These patients received either ivonescimab delivered in combination with chemotherapy, or chemotherapy alone in this global Phase III trial for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with an EGFR TKI. Ivonescimab plus chemotherapy demonstrated an improvement in intracranial progression free survival (PFS) in patients with baseline brain metastases of 10.1 months compared to 6.5 months for chemotherapy (HR 0.53 (0.33-0.84); nominal p=0.0068). In patients who did not have baseline CNS metastases, the addition of ivonescimab also showed an improvement in intracranial PFS over control arm with 15.7 months compared to 11.6 months (HR 0.72 (0.55-0.94); nominal p=0.0172). No new safety signals were identified across baseline brain metastasis subgroups.


The second poster, “Health-Related Quality of Life in Patients Previously Treated with an EGFR-TKI from HARMONi: A Phase 3 Trial of Ivonescimab vs Placebo Plus Chemotherapy” includes data from patients enrolled in HARMONi (NCT06396065). These patients received either ivonescimab delivered in combination with chemotherapy, or chemotherapy alone in this global Phase III trial for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with an EGFR TKI.


The third poster, “Health-Related Quality of Life with Ivonescimab Versus Pembrolizumab for PD-L1 Positive, NSCLC (HARMONi-2): a Randomised, Double-Blind, Phase 3 Study in China” includes data from patients enrolled in HARMONi-2 or AK112-303 (NCT05499390). These patients received either ivonescimab delivered as monotherapy, or pembrolizumab delivered as monotherapy in this Phase III study conducted exclusively in China for patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression with all data collected and analyzed by Akeso.


About the ELCC 2026 Posters


Poster Title: Intracranial Efficacy of Ivonescimab Plus Chemotherapy in EGFR TKI-Resistant, EGFR-Mutated NSCLC in the HARMONi Study

ELCC Presentation No.: 15P

Session Date & Time: Friday, March 27, 1:00 to 2:00pm CET


Poster Title: Health-Related Quality of Life in Patients Previously Treated with an EGFR-TKI from HARMONi: A Phase 3 Trial of Ivonescimab vs Placebo Plus Chemotherapy

ELCC Presentation No.: 20P

Session Date & Time: Friday, March 27, 1:00 to 2:00pm CET


Poster Title: Health-Related Quality of Life with Ivonescimab Versus Pembrolizumab for PD-L1 Positive, NSCLC (HARMONi-2): A Randomised, Double-Blind, Phase 3 Study in China

ELCC Presentation No.: 107P

Session Date & Time: Friday, March 27, 1:00 to 2:00pm CET


About Ivonescimab


Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.


This is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. We believe ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.


Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 60,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.


There are currently 15 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, four of which are Summit-sponsored global studies, one of which is a multiregional study sponsored by a cooperative group, and ten of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, the Company began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into CRC in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3.


HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026.


HARMONi-3 is a Phase III clinical trial, which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression.


HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.


HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC.


Also including Summit’s license territories, a Phase III study is planned to be conducted by GORTEC, a cooperative group dedicated to Head and Neck Oncology, in recurrent / metastatic head and neck squamous cell carcinoma (r/m HNSCC). ILLUMINE is a three-arm Phase III clinical trial which is intended to evaluate ivonescimab monotherapy, as well as ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, compared to monotherapy pembrolizumab in patients with PD-L1 positive r/m HNSCC.


In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in HARMONi-A with a manageable safety profile in each study.


HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.


HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.


HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression.


Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer.


Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US FDA for the HARMONi clinical trial setting.


About Summit Therapeutics


Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs.


Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol "SMMT"). We are headquartered in Miami, Florida, and we have additional offices in Palo Alto, California, Princeton, New Jersey, Dublin, Ireland, and Oxford, UK.


For more information, please visit https://www.smmttx.com and follow us on X @SMMT_TX.


Summit Forward-looking Statements


Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., the intended use of the net proceeds from the private placements, the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the expected timing of BLA submissions or FDA decisions, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected proceeds and uses thereof, the Company’s estimates regarding stock-based compensation, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the effects of geopolitical developments, domestic and foreign trade policies, and monetary policies, the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of filings that the Company makes with the Securities and Exchange Commission. Summit defines a “positive study” as a clinical study that with one or more prespecified primary endpoints in which one of those endpoints achieves a statistically significant benefit according to the protocol or statistical analysis plan. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.


Summit Therapeutics and the Summit Therapeutics logo are registered trademarks of Summit Therapeutics Inc. and/or its affiliates. Copyright 2026, Summit Therapeutics Inc. All Rights Reserved.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260327933390/en/
Contact Summit Investor Relations:

Dave Gancarz

Chief Business & Strategy Officer


Nathan LiaBraaten

Senior Director, Investor Relations


investors@smmttx.com

media@smmttx.com


Original: Multiple Ivonescimab Data Sets from Phase III Studies in Advanced NSCLC Patient Populations to be Featured at ELCC 2026

Summit Therapeutics to Present at Upcoming Investor ConferencesFebruary 26, 2026 6:45 PM
Business Wire
Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that it will participate in three upcoming investor conferences during March of this year. Members of the Summit leadership team will participate in individual investor meetings along with some fireside chats at the following conferences:



TD Cowen's 46th Annual Health Care Conference in Boston on Monday, March 2, 2026


Fireside chat 2:30pm ET






Jefferies Conference in Miami on Tuesday, March 10, 2026


Investor meetings only






Citizens Life Sciences Conference in Miami on Wednesday, March 11, 2026


Fireside chat 2:15pm ET






The fireside chats will be available live on our website: www.smmttx.com. An archived version of both presentations will be available on our website following the presentation.


About Ivonescimab


Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.


This is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. We believe ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.


Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 60,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.


There are currently 15 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, four of which are Summit-sponsored global studies, one of which is a multiregional study sponsored by a cooperative group, and ten of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, the Company began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into CRC in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3.


HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026.


HARMONi-3 is a Phase III clinical trial, which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression.


HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.


HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC.


Also including Summit’s license territories, a Phase III study is planned to be conducted by GORTEC, a cooperative group dedicated to Head and Neck Oncology, in recurrent / metastatic head and neck squamous cell carcinoma (r/m HNSCC). ILLUMINE is a three-arm Phase III clinical trial which is intended to evaluate ivonescimab monotherapy, as well as ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, compared to monotherapy pembrolizumab in patients with PD-L1 positive r/m HNSCC.


In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in HARMONi-A with a manageable safety profile in each study.


HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.


HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.


HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression.


Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer.


Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US FDA for the HARMONi clinical trial setting.


About Summit Therapeutics


Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs.


Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol "SMMT"). We are headquartered in Miami, Florida, and we have additional offices in Palo Alto, California, Princeton, New Jersey, Dublin, Ireland, and Oxford, UK.


For more information, please visit https://www.smmttx.com and follow us on X @SMMT_TX.


Summit Forward-looking Statements


Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., the intended use of the net proceeds from the private placements, the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the expected timing of BLA submissions or FDA decisions, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected proceeds and uses thereof, the Company’s estimates regarding stock-based compensation, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the effects of geopolitical developments, domestic and foreign trade policies, and monetary policies, the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of filings that the Company makes with the Securities and Exchange Commission. Summit defines a “positive study” as a clinical study that with one or more prespecified primary endpoints in which one of those endpoints achieves a statistically significant benefit according to the protocol or statistical analysis plan. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.


Summit Therapeutics and the Summit Therapeutics logo are trademarks of Summit Therapeutics Inc. and/or its affiliates. Copyright 2026, Summit Therapeutics Inc. All Rights Reserved.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260226560754/en/
Contact Summit Investor Relations:

Dave Gancarz

Chief Business & Strategy Officer


Nathan LiaBraaten

Senior Director, Investor Relations


investors@smmttx.com

media@smmttx.com


Original: Summit Therapeutics to Present at Upcoming Investor Conferences

Summit Therapeutics Reports Financial Results and Operational Progress for the Fourth Quarter and Year Ended December 31, 2025February 23, 2026 4:05 PM
Business Wire
HARMONi-3 Squamous Cohort of Global Phase III 1L NSCLC Study: Interim PFS Analysis Planned in Q2 2026; Final PFS and Interim OS Data Planned in Second Half of 2026


HARMONi-3 Squamous Cohort Enrollment Screening Has Been Completed


Phase III ILLUMINE Study in 1L PD-L1 Positive R/M HNSCC Sponsored by Cooperative Group, GORTEC, to Initiate; First Patient Expected in Early Q2 2026


US FDA Accepts BLA Filing Based on HARMONi Study; PDUFA Goal Action Date of November 14, 2026


First Patient Dosed in Revolution Medicines Clinical Trial Collaboration Evaluating Ivonescimab in Combination with RAS(ON) Inhibitors in RAS Mutant Tumors


GSK Collaboration Clinical Trials Evaluating Ivonescimab in Combination with GSK’s Novel B7-H3, Risvutatug Rezetecan, Expected to Start Mid-2026


Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on clinical and operational progress for the fourth quarter and year ended December 31, 2025.


Clinical & Operational Updates


Operational progress continues with ivonescimab (SMT112), an investigational, potentially first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule:



Since in-licensing ivonescimab (SMT112), from Akeso Inc. (Akeso, HKEX Code: 9926.HK) in January 2023, over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 60,000 patients have been treated in a commercial setting with ivonescimab in China, as noted by Akeso. Summit has rights to develop and commercialize ivonescimab in North America, South America, Europe, the Middle East, Africa, and Japan, while Akeso retains development and commercialization rights for remaining territories, including China.



Summit is developing ivonescimab in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), specifically conducting multiregional Phase III clinical trials in the following proposed indications:


HARMONi: Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR tyrosine kinase inhibitor (TKI)



HARMONi-3: Ivonescimab combined with chemotherapy in patients with first-line metastatic NSCLC, with two distinct cohorts to be analyzed separately for squamous tumors and non-squamous tumors



HARMONi-7: Ivonescimab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression



HARMONi-GI3: Ivonescimab combined with chemotherapy in patients with first-line unresectable metastatic CRC






Today, we provide the following updates for the global Phase III HARMONi-3 clinical trial:


For the HARMONi-3 squamous cohort:


Screening by investigators for patient enrollment in the squamous cohort of HARMONi-3 has been completed in the first quarter of 2026.



We amended the study’s statistical analysis plan and expect to conduct an interim analysis for progression free survival (PFS) in the second quarter of 2026. Overall survival (OS) is expected to be immature at the time of the interim PFS analysis.



We continue to expect to reach the prespecified number of events for the final PFS analysis, if applicable, in the second half of 2026.






For the HARMONi-3 non-squamous cohort:


Enrollment is currently expected to complete in the second half of 2026.



We expect to reach the prespecified number of events for the final PFS analysis in the first half of 2027. Interim analyses for overall survival are planned to be conducted based upon reaching prespecified numbers of events.









Today, we announce that GORTEC, a European Head and Neck Oncology and Radiotherapy Group based in France, will begin to activate clinical trial sites in the Phase III clinical study, GORTEC 2024-04 ILLUMINE (NCT07264075). This study will evaluate ivonescimab monotherapy and ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, against monotherapy pembrolizumab in a randomized three-arm study. The study is intended to be conducted in multiple countries in Europe and in China; Summit may consider the expansion of this study into the United States. The primary endpoint for the study is overall survival. The study, with approximately 780 patients with PD-L1 positive, recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC), is expected to begin enrollment early in the second quarter of 2026.


Phase II data supporting this study was previously presented at ESMO 2024, whereby ivonescimab in combination with ligufalimab demonstrated an objective response rate of 60% in 20 patients with a median PFS of 7.1 months after a median follow-up time of 4.1 months; overall survival was not mature at the time of this analysis. At the time of data cut-off for this presentation, no patients receiving ivonescimab plus ligufalimab permanently discontinued drug treatment due to treatment-related adverse events.






In January 2026, we announced that the U.S. Food & Drug Administration (FDA) has accepted for filing Summit's Biologics License Application (BLA) seeking approval for ivonescimab in combination with chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have received prior EGFR TKI therapy. The FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026. The BLA was submitted based on the overall results of the Phase III HARMONi trial.



In June 2025, we announced a clinical collaboration with Revolution Medicines, Inc. (RevMed) to evaluate ivonescimab in combination with three RAS(ON) inhibitors, including the multi-selective inhibitor daraxonrasib (RMC-6236), G12D-selective inhibitor zoldonrasib (RMC-9805), and G12C-selective inhibitor elironrasib (RMC-6291), in solid tumor settings with RAS mutations. The initial study under this collaboration, sponsored by RevMed, began enrolling patients in the first quarter of 2026.



In January 2026, we announced a clinical collaboration with GSK plc (“GSK”) to evaluate ivonescimab in combination with GSK’s novel B7-H3, risvutatug rezetecan, in multiple solid tumors. The initial study under this collaboration agreement is expected to begin dosing patients in mid-2026.



In Summit's global Phase III trials, the non-squamous cohort of HARMONi-3, HARMONi-7, and HARMONi-GI3, continue to enroll. In addition to the multiregional studies conducted and sponsored by Summit, our partners at Akeso are enrolling several single-region Phase III studies exclusively in China in multiple indications, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer.



We plan to continue further expansion of the global Phase III clinical development program for ivonescimab in additional settings and tumor types. Today, we announced the ILLUMINE study; we intend to continue to provide more details in the coming months with respect to additional Phase III studies evaluating ivonescimab beyond the announcement of the ILLUMINE study.



Clinical trial collaborations and investigator sponsored trials (ISTs) with leading academic organizations, including MD Anderson, the Memorial Sloan Kettering Cancer Center, and the Dana Farber Cancer Institute, among others, continue to progress and expand evaluating ivonescimab in solid tumors. Summit is supporting more than 60 ISTs, of which 15 are actively enrolling.



Financial Highlights


Cash and Cash Equivalents and Short-term Investments



Aggregate cash and cash equivalents and short-term investments were $713.4 million and $412.3 million at December 31, 2025 and December 31, 2024, respectively.



GAAP and Non-GAAP Operating Expenses



GAAP operating expenses were $1,094.4 million for the full year of 2025, compared to $226.0 million for the full year of 2024. The increase in GAAP operating expenses was due to the increase in stock-based compensation expense of $681.4 million primarily related to modification to our performance-based stock option awards which occurred earlier during the current fiscal year.




Non-GAAP operating expenses were $362.0 million for the full year of 2025, compared to $175.0 million for the full year of 2024. The increase in Non-GAAP operating expenses was due to expansion of clinical studies and development costs related to ivonescimab.



GAAP and Non-GAAP Research and Development (R&D) Expenses



GAAP R&D expenses were $537.7 million for the full year of 2025, compared to $150.8 million for the full year of 2024. The increase was due to the increase in stock-based compensation expense of $202.5 million primarily related to modification to our performance-based stock option awards which occurred earlier during the current fiscal year.



Non-GAAP R&D expenses were $319.2 million for the full year of 2025, compared to $134.8 million for the full year of 2024. The increase is primarily due to initiating new clinical trials and expanding current clinical trials from last year.



GAAP and Non-GAAP General and Administrative (G&A) Expenses



GAAP G&A expenses were $556.7 million for the full year of 2025, compared to $60.2 million for the full year of 2024. The increase was due to the increase in stock-based compensation expense of $478.9 million primarily related to modification to our performance-based stock option awards which occurred earlier during the current fiscal year.



Non-GAAP G&A expenses were $42.8 million for the full year of 2025, compared to $25.2 million for the full year of 2024. The increase is related to building our infrastructure to support the development of ivonescimab.



GAAP and Non-GAAP Net Loss



GAAP net loss for the full year of 2025 and 2024 was $1,079.6 million or $(1.44) per basic and diluted share, and $221.3 million or $(0.31) per basic and diluted share, respectively.



Non-GAAP net loss for the full year of 2025 and 2024 was $347.2 million or $(0.46) per basic and diluted share, and $170.3 million or $(0.24) per basic and diluted share, respectively.



Use of Non-GAAP Financial Measures


This release includes measures that are not in accordance with U.S. generally accepted accounting principles (“Non-GAAP measures”). These Non-GAAP measures should be viewed in addition to, and not as a substitute for, Summit's reported GAAP results, and may be different from Non-GAAP measures used by other companies. In addition, these Non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Summit management uses these Non-GAAP measures for internal budgeting and forecasting purposes and to evaluate Summit’s financial performance. Summit management believes the presentation of these Non-GAAP measures is useful to investors for comparing prior periods and analyzing ongoing business trends and operating results. For further information regarding these Non-GAAP measures, please refer to the tables presenting reconciliations of our Non-GAAP results to our U.S. GAAP results and the “Notes on our Non-GAAP Financial Information” that accompany this press release.


Fourth Quarter 2025 Earnings Call


Summit will host an earnings call this afternoon, Monday, February 23, 2026, at 4:30pm ET. The conference call will be accessible by dialing (800) 715-9871 (toll-free domestic) or (646) 307-1963 (international) using conference code 9472421. We encourage you to join the live webcast, which is accessible through Summit’s website www.smmttx.com, as we intend to display slides simultaneously. An archived edition of the webcast will be available on our website after the call.


About Ivonescimab


Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.


This is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. We believe ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.


Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 60,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.


There are currently 15 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, four of which are Summit-sponsored global studies, one of which is a multiregional study sponsored by a cooperative group, and ten of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, the Company began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into CRC in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3.


HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026.


HARMONi-3 is a Phase III clinical trial, which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression.


HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.


HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC.


Also including Summit’s license territories, a Phase III study is planned to be conducted by GORTEC, a cooperative group dedicated to Head and Neck Oncology, in recurrent / metastatic head and neck squamous cell carcinoma (r/m HNSCC). ILLUMINE is a three-arm Phase III clinical trial which is intended to evaluate ivonescimab monotherapy, as well as ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, compared to monotherapy pembrolizumab in patients with PD-L1 positive r/m HNSCC.


In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in HARMONi-A with a manageable safety profile in each study.


HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.


HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.


HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression.


Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer.


Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US FDA for the HARMONi clinical trial setting.


About Summit Therapeutics


Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs.


Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol "SMMT"). We are headquartered in Miami, Florida, and we have additional offices in Palo Alto, California, Princeton, New Jersey, Dublin, Ireland, and Oxford, UK.


For more information, please visit https://www.smmttx.com and follow us on X @SMMT_TX.


Summit Forward-looking Statements


Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., the intended use of the net proceeds from the private placements, the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the expected timing of BLA submissions or FDA decisions, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected proceeds and uses thereof, the Company’s estimates regarding stock-based compensation, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the effects of geopolitical developments, domestic and foreign trade policies, and monetary policies, the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of filings that the Company makes with the Securities and Exchange Commission. Summit defines a “positive study” as a clinical study that with one or more prespecified primary endpoints in which one of those endpoints achieves a statistically significant benefit according to the protocol or statistical analysis plan. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.


Summit Therapeutics and the Summit Therapeutics logo are trademarks of Summit Therapeutics Inc. and/or its affiliates. Copyright 2026, Summit Therapeutics Inc. All Rights Reserved.




Summit Therapeutics Inc.








GAAP Consolidated Statements of Operations








(in millions, except per share data)










 



 






Three Months Ended December 31,






 






Year Ended December 31,








 






 






2025






 






 






 






2024






 






 






 






2025






 






 






 






2024






 








Operating expenses:






 






 






 






 






 






 






 








Research and development






$






147.3






 






 






$






51.4






 






 






$






537.7






 






 






$






150.8






 








Acquired in-process research and development






 






—






 






 






 






—






 






 






 






—






 






 






 






15.0






 








General and administrative






 






77.7






 






 






 






14.2






 






 






 






556.7






 






 






 






60.2






 








Total operating expenses






 






225.0






 






 






 






65.6






 






 






 






1,094.4






 






 






 






226.0






 








Other income, net






 






5.8






 






 






 






4.4






 






 






 






14.8






 






 






 






13.4






 








Interest expense






 






—






 






 






 






—






 






 






 






—






 






 






 






(8.7






)








Net loss






$






(219.2






)






 






$






(61.2






)






 






$






(1,079.6






)






 






$






(221.3






)








 






 






 






 






 






 






 






 








Net loss per share attributable to common shareholders per share, basic and diluted






$






(0.29






)






 






$






(0.08






)






 






$






(1.44






)






 






$






(0.31






)









Summit Therapeutics Inc.








GAAP Consolidated Balance Sheet Information








(in millions)











 



 






 






December 31, 2025






 






December 31, 2024








Cash and cash equivalents and short-term investments






 






$






713.4






 






$






412.3








Total assets






 






$






751.2






 






$






435.6








Total liabilities






 






$






92.3






 






$






46.8








Total stockholders' equity






 






$






658.9






 






$






388.8









Summit Therapeutics Inc.








GAAP Consolidated Statement of Cash Flows Information








(in millions)









 



 






 






 








 






 






Year Ended December 31,








 






 






 






2025






 






 






 






2024






 








Net cash used in operating activities






 






$






(322.9






)






 






$






(142.1






)








Net cash used in investing activities






 






 






(174.3






)






 






 






(205.3






)








Net cash provided by financing activities






 






 






617.5






 






 






 






381.2






 








Effect of exchange rates on cash and cash equivalents






 






 






0.1






 






 






 






—






 








Increase in cash, cash equivalents and restricted cash






 






$






120.4






 






 






$






33.8






 









Summit Therapeutics Inc.








Schedule Reconciling Selected Non-GAAP Financial Measures








(in millions, except per share data)











 



 






 






 






 






 








 






 






Three Months Ended December 31,






 






Year Ended




December 31,








 






 






 






2025






 






 






 






2024






 






 






 






2025






 






 






 






2024






 








Reconciliation of GAAP to Non-GAAP Research and Development Expense






 






 






 






 






 






 






 






 








GAAP Research and Development






 






$






147.3






 






 






$






51.4






 






 






$






537.7






 






 






$






150.8






 








Stock-based compensation (Note 1)






 






 






(45.3






)






 






 






(4.3






)






 






 






(218.5






)






 






 






(16.0






)








Non-GAAP Research and Development






 






$






102.0






 






 






$






47.1






 






 






$






319.2






 






 






$






134.8






 








 






 






 






 






 






 






 






 






 








Reconciliation of GAAP to Non-GAAP General and Administrative Expenses






 






 






 






 






 






 






 






 








GAAP General and Administrative






 






$






77.7






 






 






$






14.2






 






 






$






556.7






 






 






$






60.2






 








Stock-based compensation (Note 1)






 






 






(66.4






)






 






 






(6.7






)






 






 






(513.9






)






 






 






(35.0






)








Non-GAAP General and Administrative






 






$






11.3






 






 






$






7.5






 






 






$






42.8






 






 






$






25.2






 








 






 






 






 






 






 






 






 






 








Reconciliation of GAAP to Non-GAAP Operating Expenses






 






 






 






 






 






 






 






 








GAAP Operating Expenses






 






$






225.0






 






 






$






65.6






 






 






$






1,094.4






 






 






$






226.0






 








Stock-based compensation (Note 1)






 






 






(111.7






)






 






 






(11.0






)






 






 






(732.4






)






 






 






(51.0






)








Non-GAAP Operating Expense






 






$






113.3






 






 






$






54.6






 






 






$






362.0






 






 






$






175.0






 








 






 






 






 






 






 






 






 






 








Reconciliation of GAAP Net Loss to Non-GAAP Net Loss






 






 






 






 






 






 






 






 








GAAP Net Loss






 






$






(219.2






)






 






$






(61.2






)






 






$






(1,079.6






)






 






$






(221.3






)








Stock-based compensation (Note 1)






 






 






111.7






 






 






 






11.0






 






 






 






732.4






 






 






 






51.0






 








Non-GAAP Net Loss






 






$






(107.5






)






 






$






(50.2






)






 






$






(347.2






)






 






$






(170.3






)








 






 






 






 






 






 






 






 






 








Reconciliation of GAAP Net Loss to Non-GAAP Net Loss Per Common Share






 






 






 






 






 






 






 






 








GAAP Net Loss Per Basic and Diluted Common Share






 






$






(0.29






)






 






$






(0.08






)






 






$






(1.44






)






 






$






(0.31






)








Stock-based compensation (Note 1)






 






 






0.15






 






 






 






0.01






 






 






 






0.98






 






 






 






0.07






 








Non-GAAP Net loss Per Basic and Diluted Common Share






 






$






(0.14






)






 






$






(0.07






)






 






$






(0.46






)






 






$






(0.24






)








Basic and Diluted Common Shares






 






 






766.4






 






 






 






737.5






 






 






 






747.7






 






 






 






718.5






 









Summit Therapeutics Inc.








Schedule Reconciling Selected Non-GAAP Financial Measures








(in millions)









 



 






 






Unaudited








 






 






Three Months Ended








 






 






December 31, 2025






 






September 30, 2025






 






June 30, 2025






 






March 31, 2025






 






December 31, 2024








Reconciliation of GAAP to Non-GAAP Operating Expenses






 






 






 






 






 






 






 






 






 






 








GAAP Operating Expenses






 






$






225.0






 






 






$






234.2






 







$






568.4






 






 






$






66.8






 






 






$






65.6






 








Stock-based compensation (Note 1)






 






 






(111.7






)






 






 






(130.8






)






 






 






(478.8






)






 






 






(11.1






)







 






(11.0






)








Non-GAAP Operating Expense






 






$






113.3






 






 






$






103.4






 






 






$






89.6






 






 






$






55.7






 






 






$






54.6






 








 






 






 






 






 






 






 






 






 






 






 








Reconciliation of GAAP Net Loss to Non-GAAP Net Loss






 






 






 






 






 






 






 






 






 






 








GAAP Net Loss






 






$






(219.2






)






 






$






(231.8






)






 






$






(565.7






)






 






$






(62.9






)






 






$






(61.2






)








Stock-based compensation (Note 1)






 






 






111.7






 






 






 






130.8






 






 






 






478.8






 






 






 






11.1






 






 






 






11.0






 








Non-GAAP Net Loss






 






$






(107.5






)






 






$






(101.0






)






 






$






(86.9






)






 






$






(51.8






)






 






$






(50.2






)








 






 






 






 






 






 






 






 






 






 






 







Summit Therapeutics Inc.

Notes on our Non-GAAP Financial Information


Non-GAAP financial measures adjust GAAP financial measures for the items listed below. These Non-GAAP measures should be viewed in addition to, and not as a substitute for Summit's reported GAAP results, and may be different from Non-GAAP measures used by other companies. In addition, these Non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Summit management uses these Non-GAAP measures for internal budgeting and forecasting purposes and to evaluate Summit’s financial performance. Summit management believes the presentation of these Non-GAAP measures is useful to investors for comparing prior periods and analyzing ongoing business trends and operating results.


Each of Non-GAAP Research and Development Expense, Non-GAAP General and Administrative Expenses, Non-GAAP Operating Expenses, Non-GAAP Net Loss and Non-GAAP EPS differ from GAAP in that such measures exclude the non-cash charges and costs associated with stock-based compensation.


Note 1: Stock-based compensation is a non-cash charge and costs calculated for this expense can vary year-over-year depending on the stock price of awards on the date of grant as well as the timing of compensation award arrangement.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260223856924/en/
Contact Summit Investor Relations:

Dave Gancarz

Chief Business & Strategy Officer


Nathan LiaBraaten

Senior Director, Investor Relations


investors@smmttx.com

media@smmttx.com


Original: Summit Therapeutics Reports Financial Results and Operational Progress for the Fourth Quarter and Year Ended December 31, 2025

Summit Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)January 30, 2026 4:30 PM
Business Wire
Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today announced the grant of inducement awards of options to purchase a collective total of up to 257,368 shares of common stock. Awards were made to 20 new employees of the Company. The awards were granted as an inducement material to the new employees becoming employees of the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and have been approved by the Company’s Compensation Committee. The inducement awards were granted on January 26, 2026. The options have a ten (10) year term and an exercise price of $16.56 per share, the closing price per share of the Company’s common stock as reported by Nasdaq on January 26, 2026. The options were granted from a pool of equity incentives reserved by the Compensation Committee on January 22, 2025 for issuance as inducements to new employees in accordance with Nasdaq Listing Rule 5635(c)(4).


The options awarded to the recipients are subject to vesting in equal annual installments over a four-year period. The options awarded are subject to the terms of a stock option agreement to be executed by the recipient of the grant.


About Summit Therapeutics


Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs.


Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol "SMMT"). We are headquartered in Miami, Florida, and we have additional offices in Palo Alto, California, Princeton, New Jersey, Dublin, Ireland, and Oxford, UK.


For more information, please visit https://www.smmttx.com and follow us on X @SMMT_TX.


Summit Forward-looking Statements


Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., the intended use of the net proceeds from the private placements, the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the expected timing of BLA submissions or FDA decisions, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected proceeds and uses thereof, the Company’s estimates regarding stock-based compensation, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the effects of geopolitical developments, domestic and foreign trade policies, and monetary policies, the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of filings that the Company makes with the Securities and Exchange Commission. Summit defines a “positive study” as a clinical study that with one or more prespecified primary endpoints in which one of those endpoints achieves a statistically significant benefit according to the protocol or statistical analysis plan. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.


Summit Therapeutics and the Summit Therapeutics logo are trademarks of Summit Therapeutics Inc. and/or its affiliates

Copyright 2026, Summit Therapeutics Inc. All Rights Reserved

View source version on businesswire.com: https://www.businesswire.com/news/home/20260130371236/en/
Contact Summit Investor Relations:

Dave Gancarz

Chief Business & Strategy Officer


Nathan LiaBraaten

Senior Director, Investor Relations


investors@smmttx.com

media@smmttx.com


Original: Summit Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Summit Therapeutics Shares Climb Amid Rumored $15B Deal Talks with AstraZeneca

July 3, 2025

Shares of Summit Therapeutics (NASDAQ:SMMT) jumped 5% on Thursday following reports that the company is in advanced negotiations with AstraZeneca (NASDAQ:AZN) over a potential multi-billion-dollar licensing agreement. Meanwhile, AstraZeneca’s stock dipped 2% amid investor reactions to the potential outlay.

Citing sources familiar with the matter, Bloomberg reported that AstraZeneca is eyeing Summit’s experimental lung cancer drug, ivonescimab, in a deal that could be worth up to $15 billion. The proposed agreement would reportedly include a large upfront payment with additional performance-based milestone payouts.

The report also noted that Summit is not exclusively negotiating with AstraZeneca and has held similar discussions with other major pharmaceutical companies, reflecting broad interest in the promising oncology candidate. While talks are said to be progressing, the deal is not finalized, and there remains a possibility that negotiations could fall through or that Summit could select an alternate partner.

https://ih.advfn.com/market-news/article/12079/summit-therapeutics-shares-climb-amid-rumored-15b-deal-talks-with-astrazeneca

$SMMT

Drop based on OS, not sure why anyone thought Ivonescimab would show significant OS data.

Ivonescimab got approval in China based on progression free survival
HARMONi-2

Ivonescimab, reduced the risk of tumor progression by 49% compared to Keytruda
At the median, patients treated with ivonescimab went 11.1 months before their tumors began to grow again compared to 5.8 months for patients on Keytruda. 

HARMONi,
The actual numbers were not released for the latest trial. Complete data to be released at future medical conference. Summit wants hope the OS data matures and is significant.

Summit does plan to submit BLA filing based on the data already collected.

- Personally not expecting OS to be significant in my investment thesis. If PFS is consistent with previous trials patients should be given the ivonescimab option. A slower path to approval unless doctors and patients pressure FDA

Robert Duggan is a living legend SMMT will sell more than PCYC a CEO who wants success and victory for patients and shareholders god bless.He will sell this soon he is getting old 81 years old,

$SMMT

Only SMMT and ETNB the rest is Bitcoin and AI exposure!

$SMMT

This how a CEO navigates and executes not like some cum swapping clowns who can't get shit done. Duggan is the real deal!

Don't sleep on it this is mid cap turning into a large cap in real time.

$SMMT

Re Loaded the core position houses $

27k shares.

Robert Duggan 81 years old net worth 15.6 Billion founder of Summit Therapeutics

$SMMT

What happened today ??

IMMUNO STOCK NEWSLETTER: 03/21/25: $INMB terrific. $IOVA & $SMMT stalled.
In more unknown Immuno stock $ESLA @ $.90s: w/ recent $16 one year target BynumETF... PATIENTS UPDATE DUE..Clinical Trial run by most prominent immuno scientist at M. Sloan Kettering in NYC. Most highly regarded hospital in the USA.
https://finance.yahoo.com/news/estrella-immunopharma-achieves-complete-response-160000432.html
Website:
https://www.estrellabio.com/

Akesobio claims lung cancer drug significantly outperforms Keytruda in trials


https://biz.chosun.com/en/en-science/2025/03/16/J7DF4OOVDVBUFODUYH3LDUUH4A/

Don't bet against Duggan CEO SMMT you may go bankrupt who is short from $3.00 LOL

$SMMT

Merck2.0 Ivonescimab Better and Safer for cancer Keytruda

$SMMT


$SMMT