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Summit TherapeuticsDDocument history
Earnings documents stored for SMMT.
Investor releaseQuarter not tagged2026-08-28Why Is Corcept (CORT) Down 1.2% Since Last Earnings Report?
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Why Is Corcept (CORT) Down 1.2% Since Last Earnings Report?
A month has gone by since the last earnings report for Corcept Therapeutics (CORT). Shares have lost about 1.2% in that time frame, underperforming the S&P 500. But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is Corcept due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important catalysts. Corcept reported second-quarter 2026 earnings of 36 cents per share, outperforming the Zacks Consensus Estimate of a loss of 4 cents. In the year-ago quarter, the company reported earnings of 29 cents. Second-quarter revenues rose nearly 32% year over year to $256.1 million and surpassed the Zacks Consensus Estimate of $216 million. Growth was driven by higher Korlym sales and contribution from the newly launched product, Lifyorli (relacorilant). Corcept’s top line consisted of product sales from Cushing’s syndrome drug Korlym and newly launched ovarian cancer drug Lifyorli. In the second quarter of 2026, product revenues from Korlym were $208.6 million, up 7.3% year over year. However, the metric missed our model estimate of $212.2 million. Lifyorli generated $47.6 million in the second quarter of 2026, reflecting its first quarter of commercial sales. Second-quarter operating expenses increased 28.1% year over year to $214.8 million. The rise reflected spending related to the Lifyorli launch and continued investment in the company’s Cushing’s syndrome business. Selling, general and administrative expenses surged 51.1% to $156.9 million. Research and development expenses declined 10.9% to $53.9 million. Corcept ended the June quarter with cash and investments of $544.6 million, up from $515.4 million as of March 31, 2026. Corcept raised its 2026 revenue guidance to $1.1-$1.2 billion from the previous $950 million to $1.05 billion. Management said that the revised outlook reflects strength across the endocrinology and oncology businesses. In the past month, investors have witnessed a upward trend in estimates revision. The consensus estimate has shifted 86.02% due to these changes. Currently, Corcept has a nice Growth Score of B, however its Momentum Score is doing a bit better with an A. However, the stock was allocated a score of D on the value side, putting it i…Read full documentShow less
A month has gone by since the last earnings report for Corcept Therapeutics (CORT). Shares have lost about 1.2% in that time frame, underperforming the S&P 500. But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is Corcept due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important catalysts. Corcept reported second-quarter 2026 earnings of 36 cents per share, outperforming the Zacks Consensus Estimate of a loss of 4 cents. In the year-ago quarter, the company reported earnings of 29 cents. Second-quarter revenues rose nearly 32% year over year to $256.1 million and surpassed the Zacks Consensus Estimate of $216 million. Growth was driven by higher Korlym sales and contribution from the newly launched product, Lifyorli (relacorilant). Corcept’s top line consisted of product sales from Cushing’s syndrome drug Korlym and newly launched ovarian cancer drug Lifyorli. In the second quarter of 2026, product revenues from Korlym were $208.6 million, up 7.3% year over year. However, the metric missed our model estimate of $212.2 million. Lifyorli generated $47.6 million in the second quarter of 2026, reflecting its first quarter of commercial sales. Second-quarter operating expenses increased 28.1% year over year to $214.8 million. The rise reflected spending related to the Lifyorli launch and continued investment in the company’s Cushing’s syndrome business. Selling, general and administrative expenses surged 51.1% to $156.9 million. Research and development expenses declined 10.9% to $53.9 million. Corcept ended the June quarter with cash and investments of $544.6 million, up from $515.4 million as of March 31, 2026. Corcept raised its 2026 revenue guidance to $1.1-$1.2 billion from the previous $950 million to $1.05 billion. Management said that the revised outlook reflects strength across the endocrinology and oncology businesses. In the past month, investors have witnessed a upward trend in estimates revision. The consensus estimate has shifted 86.02% due to these changes. Currently, Corcept has a nice Growth Score of B, however its Momentum Score is doing a bit better with an A. However, the stock was allocated a score of D on the value side, putting it in the bottom 40% for value investors. Overall, the stock has an aggregate VGM Score of B. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been trending upward for the stock, and the magnitude of these revisions looks promising. Interestingly, Corcept has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Corcept belongs to the Zacks Medical - Drugs industry. Another stock from the same industry, Summit Therapeutics PLC (SMMT), has gained 6.6% over the past month. More than a month has passed since the company reported results for the quarter ended June 2026. Summit Therapeutics reported revenues of $0 million in the last reported quarter, representing a year-over-year change of 0%. EPS of -$0.28 for the same period compares with -$0.76 a year ago. For the current quarter, Summit Therapeutics is expected to post a loss of $0.28 per share, indicating a change of +9.7% from the year-ago quarter. The Zacks Consensus Estimate remained unchanged over the last 30 days. Summit Therapeutics has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of F. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Corcept Therapeutics Incorporated (CORT) : Free Stock Analysis Report Summit Therapeutics PLC (SMMT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-08-27Summit Therapeutics (SMMT) Published Phase III HARMONi Results In The Lancet Oncology
Simply Wall St.
Summit Therapeutics (SMMT) Published Phase III HARMONi Results In The Lancet Oncology
Summit Therapeutics (NasdaqGM:SMMT) reported that Phase III HARMONi trial results for ivonescimab in EGFR-mutated NSCLC have been published in The Lancet Oncology. The pivotal data show significant clinical benefit for patients in the HARMONi study, according to the published results. The company highlighted that ivonescimab for EGFR-mutated NSCLC is currently under ongoing FDA regulatory review. The growing flow of late stage oncology and immunotherapy data makes it worth looking at companies applying similar approaches in AI driven drug discovery and clinical development through 74 profitable AI stocks that aren't just burning cash. Summit Therapeutics is a GB-based biopharmaceutical company focused on discovering, developing, and commercializing treatments designed to be easier for patients, physicians, caregivers, and health systems to use, which aligns closely with its work on ivonescimab in lung cancer. 2 things going right for Summit Therapeutics that this headline doesn't cover. For investors, the HARMONi publication reinforces the bull case that Summit Therapeutics has a late stage asset with clinically meaningful progression free survival data in a defined EGFR mutated NSCLC niche, directly tying into the Narrative’s focus on ivonescimab led Phase III outcomes as the key catalyst. At the same time, it highlights the bear argument that everything still depends on regulatory decisions and eventual commercial uptake in markets that already use checkpoint plus chemotherapy combinations, with Summit still reporting no product revenue and ongoing high R&D spend. If we take a look at the community Narrative for Summit Therapeutics, we can see how this news fits into the bigger investment story. The clearest signal to watch is the U.S. FDA’s HARMONi Biologics License Application review, including the Prescription Drug User Fee Act goal date of November 14, 2026 and any FDA commentary on overall survival expectations for ivonescimab in EGFR mutated NSCLC, since that outcome will strongly influence whether the broader Phase III program can translate into meaningful future revenue for Summit Therapeutics. For the full picture including more risks and rewards, check out the complete Summit Therapeutics analysis. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased metho…Read full documentShow less
Summit Therapeutics (NasdaqGM:SMMT) reported that Phase III HARMONi trial results for ivonescimab in EGFR-mutated NSCLC have been published in The Lancet Oncology. The pivotal data show significant clinical benefit for patients in the HARMONi study, according to the published results. The company highlighted that ivonescimab for EGFR-mutated NSCLC is currently under ongoing FDA regulatory review. The growing flow of late stage oncology and immunotherapy data makes it worth looking at companies applying similar approaches in AI driven drug discovery and clinical development through 74 profitable AI stocks that aren't just burning cash. Summit Therapeutics is a GB-based biopharmaceutical company focused on discovering, developing, and commercializing treatments designed to be easier for patients, physicians, caregivers, and health systems to use, which aligns closely with its work on ivonescimab in lung cancer. 2 things going right for Summit Therapeutics that this headline doesn't cover. For investors, the HARMONi publication reinforces the bull case that Summit Therapeutics has a late stage asset with clinically meaningful progression free survival data in a defined EGFR mutated NSCLC niche, directly tying into the Narrative’s focus on ivonescimab led Phase III outcomes as the key catalyst. At the same time, it highlights the bear argument that everything still depends on regulatory decisions and eventual commercial uptake in markets that already use checkpoint plus chemotherapy combinations, with Summit still reporting no product revenue and ongoing high R&D spend. If we take a look at the community Narrative for Summit Therapeutics, we can see how this news fits into the bigger investment story. The clearest signal to watch is the U.S. FDA’s HARMONi Biologics License Application review, including the Prescription Drug User Fee Act goal date of November 14, 2026 and any FDA commentary on overall survival expectations for ivonescimab in EGFR mutated NSCLC, since that outcome will strongly influence whether the broader Phase III program can translate into meaningful future revenue for Summit Therapeutics. For the full picture including more risks and rewards, check out the complete Summit Therapeutics analysis. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include SMMT. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2026-08-26Update: US Equity Futures Mostly Flat Pre-Bell as Traders Weigh Inflation Data, Await Nvidia Results
MT Newswires
Update: US Equity Futures Mostly Flat Pre-Bell as Traders Weigh Inflation Data, Await Nvidia Results
(Updates with economic data, recent oil price changes, world markets' overview, and corporate stock
Investor releaseQuarter not tagged2026-08-26Summit Therapeutics shares rise after partner reports positive Phase III cancer trial results
InvestorsHub
Summit Therapeutics shares rise after partner reports positive Phase III cancer trial results
Summit Therapeutics Inc. (NASDAQ:SMMT) shares climbed 7.75% on Wednesday after partner Akeso Inc. reported positive topline results from a Phase III study evaluating ivonescimab in advanced biliary tract cancer. Akeso said the HARMONi-GI1 trial achieved its primary endpoint, with ivonescimab combined with chemotherapy demonstrating statistically significant superiority in overall survival compared with durvalumab plus chemotherapy when used as a first-line treatment. The study also met its key secondary endpoints covering progression-free survival and objective response rate. The Phase III trial enrolled 682 patients in China, where ivonescimab is already approved for certain non-small cell lung cancer indications. However, the drug remains investigational and has not been approved in Summit’s licensed territories, which include the United States and Europe. Detailed findings from HARMONi-GI1 are expected to be presented at an upcoming medical congress, potentially providing investors with greater clarity on the magnitude of the survival benefit observed in the trial. Despite the positive topline outcome, H.C. Wainwright analyst Mitchell S. Kapoor maintained a Neutral rating on Summit Therapeutics, noting that additional data will be required to assess the clinical significance of the results. “We believe that establishes activity in Chinese BTC, but without the OS HR we cannot tell whether ivonescimab adds a modest survival benefit or materially improves on durvalumab. Summit has not disclosed a global BTC study; we assign no ex-China BTC economics. Per our current visibility, the next stock-moving item is likely to be HARMONi-3 final PFS/interim OS in 2H26. We reiterate our Neutral rating without a price target,” Kapoor commented. His assessment suggests that the overall survival hazard ratio will be particularly important in determining whether ivonescimab offers a meaningful improvement over the existing treatment approach. Guggenheim analyst Brad Canino took a more optimistic view, reiterating a Buy rating on Summit Therapeutics with a $38.00 price target. “We think this BTC result adds to the consistency of effect that should add weight to the argument that the China 1L lung cancer results are reproducible and generalizable. BTC is a relatively small market, so at SMMT’s valuation, we think the lung read-through is more important than the new unlocked…Read full documentShow less
Summit Therapeutics Inc. (NASDAQ:SMMT) shares climbed 7.75% on Wednesday after partner Akeso Inc. reported positive topline results from a Phase III study evaluating ivonescimab in advanced biliary tract cancer. Akeso said the HARMONi-GI1 trial achieved its primary endpoint, with ivonescimab combined with chemotherapy demonstrating statistically significant superiority in overall survival compared with durvalumab plus chemotherapy when used as a first-line treatment. The study also met its key secondary endpoints covering progression-free survival and objective response rate. The Phase III trial enrolled 682 patients in China, where ivonescimab is already approved for certain non-small cell lung cancer indications. However, the drug remains investigational and has not been approved in Summit’s licensed territories, which include the United States and Europe. Detailed findings from HARMONi-GI1 are expected to be presented at an upcoming medical congress, potentially providing investors with greater clarity on the magnitude of the survival benefit observed in the trial. Despite the positive topline outcome, H.C. Wainwright analyst Mitchell S. Kapoor maintained a Neutral rating on Summit Therapeutics, noting that additional data will be required to assess the clinical significance of the results. “We believe that establishes activity in Chinese BTC, but without the OS HR we cannot tell whether ivonescimab adds a modest survival benefit or materially improves on durvalumab. Summit has not disclosed a global BTC study; we assign no ex-China BTC economics. Per our current visibility, the next stock-moving item is likely to be HARMONi-3 final PFS/interim OS in 2H26. We reiterate our Neutral rating without a price target,” Kapoor commented. His assessment suggests that the overall survival hazard ratio will be particularly important in determining whether ivonescimab offers a meaningful improvement over the existing treatment approach. Guggenheim analyst Brad Canino took a more optimistic view, reiterating a Buy rating on Summit Therapeutics with a $38.00 price target. “We think this BTC result adds to the consistency of effect that should add weight to the argument that the China 1L lung cancer results are reproducible and generalizable. BTC is a relatively small market, so at SMMT’s valuation, we think the lung read-through is more important than the new unlocked BTC commercial opportunity,” Canino commented. The analyst therefore sees the results as potentially significant beyond the biliary tract cancer opportunity, particularly if they strengthen confidence in ivonescimab’s performance across other tumour types. With detailed HARMONi-GI1 data still to come and further HARMONi-3 results expected in the second half of 2026, investors are likely to remain focused on whether ivonescimab can demonstrate consistent clinical benefits across Summit’s broader oncology development programme. Summit Therapeutics stock price
Investor releaseQuarter not tagged2026-08-25Ivonescimab Plus Chemotherapy Global Phase III HARMONi Primary Analysis Results Published in The Lancet Oncology
Business Wire
Ivonescimab Plus Chemotherapy Global Phase III HARMONi Primary Analysis Results Published in The Lancet Oncology
First Immunotherapy-Based Regimen to Show Statistically Significant and Clinically Meaningful PFS Benefit in a Global Phase III Study of EGFR-Mutated NSCLC after Third-Generation EGFR TKI Progression Updated OS Data to Be Presented at WCLC 2026 MIAMI, August 25, 2026--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) today announced the publication of primary analysis results from the global Phase III HARMONi clinical trial in The Lancet Oncology. In HARMONi, ivonescimab in combination with platinum-doublet chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to placebo plus platinum-doublet chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose disease progressed following treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI). The manuscript, titled "Ivonescimab plus chemotherapy versus placebo plus chemotherapy in patients with advanced EGFR-mutated non-small cell lung cancer after EGFR-TKI progression (HARMONi): a randomised, double-blind, multi-centre phase 3 trial," reports primary efficacy and safety results from the study conducted at 114 cancer centers and hospitals across Asia, Europe, and North America. The study was designed to evaluate whether ivonescimab plus chemotherapy could improve clinical outcomes in a setting where treatment options remain limited after progression on EGFR-directed therapy. "Once a patient with EGFR-mutated lung cancer progresses after a third-generation EGFR TKI, there are limited treatment options for those patients and the survival may be limited," said Xiuning Le, M.D., Ph.D., Associate Professor, Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, and lead author of the HARMONi manuscript. "In this patient population, traditional anti-PD-(L)1 therapies have not established a clear benefit in prior Phase III studies. The HARMONi results suggest that ivonescimab’s mechanism of action, targeting of PD-1 and VEGF simultaneously in one construct, may offer a clinically meaningful strategy with the potential to improve outcomes for patients." HARMONi Primary Analysis Results At the primary analysis, ivonescimab in combination with chemotherapy demonstrated a…Read full documentShow less
First Immunotherapy-Based Regimen to Show Statistically Significant and Clinically Meaningful PFS Benefit in a Global Phase III Study of EGFR-Mutated NSCLC after Third-Generation EGFR TKI Progression Updated OS Data to Be Presented at WCLC 2026 MIAMI, August 25, 2026--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) today announced the publication of primary analysis results from the global Phase III HARMONi clinical trial in The Lancet Oncology. In HARMONi, ivonescimab in combination with platinum-doublet chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to placebo plus platinum-doublet chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose disease progressed following treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI). The manuscript, titled "Ivonescimab plus chemotherapy versus placebo plus chemotherapy in patients with advanced EGFR-mutated non-small cell lung cancer after EGFR-TKI progression (HARMONi): a randomised, double-blind, multi-centre phase 3 trial," reports primary efficacy and safety results from the study conducted at 114 cancer centers and hospitals across Asia, Europe, and North America. The study was designed to evaluate whether ivonescimab plus chemotherapy could improve clinical outcomes in a setting where treatment options remain limited after progression on EGFR-directed therapy. "Once a patient with EGFR-mutated lung cancer progresses after a third-generation EGFR TKI, there are limited treatment options for those patients and the survival may be limited," said Xiuning Le, M.D., Ph.D., Associate Professor, Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, and lead author of the HARMONi manuscript. "In this patient population, traditional anti-PD-(L)1 therapies have not established a clear benefit in prior Phase III studies. The HARMONi results suggest that ivonescimab’s mechanism of action, targeting of PD-1 and VEGF simultaneously in one construct, may offer a clinically meaningful strategy with the potential to improve outcomes for patients." HARMONi Primary Analysis Results At the primary analysis, ivonescimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS, as assessed by independent radiographic review committee, compared to placebo plus chemotherapy. Median PFS was 6.8 months in the ivonescimab-plus-chemotherapy arm compared to 4.4 months in the placebo-plus-chemotherapy arm, with a hazard ratio of 0.52 (95% CI: 0.41–0.66; p<0.0001). The PFS benefit was consistent across preplanned subgroups. At the time of the primary overall survival (OS) analysis, ivonescimab plus chemotherapy showed a positive OS trend but did not reach statistical significance. The safety profile observed with ivonescimab plus chemotherapy was manageable and consistent with prior clinical experience; treatment-related grade 3–5 hemorrhage events occurred in less than 1% of patients in the ivonescimab-plus-chemotherapy arm. "The publication of HARMONi in The Lancet Oncology provides peer-reviewed support for the scientific rationale behind ivonescimab and its dual targeting of PD-1 and VEGF in a Phase III setting with high unmet need," said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit Therapeutics. "In a patient population where outcomes after EGFR TKI progression remain challenging, these data further support our ongoing development of ivonescimab, and we continue to evaluate longer-term results from HARMONi as the data mature. Our commitment remains focused on bringing meaningful new options to patients with significant unmet medical need." "The publication of the HARMONi primary analysis data is a meaningful milestone for the patients, caregivers, investigators, and clinical teams who contributed to this global study," said Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit Therapeutics. "Together with Akeso, we remain focused on advancing ivonescimab with urgency, discipline, and purpose as we work to translate promising science into meaningful impact for patients." Additional HARMONi OS Follow-Up Data to Be Presented at WCLC 2026 On July 22, 2026, Summit announced an updated OS analysis from HARMONi based on a June 2026 data cut-off that showed ivonescimab plus chemotherapy continued to demonstrate a positive OS trend and a consistent efficacy and safety profile in Asian and western patients compared with chemotherapy alone; western patients achieved an OS hazard ratio of 0.76, consistent with the global study population. Additional details from the updated HARMONi data analysis will be presented at the International Association for the Study of Lung Cancer’s (IASLC) 2026 World Conference on Lung Cancer (WCLC 2026) on September 15, 2026, at 1:02–1:12 p.m. KST (12:02–12:12 a.m. EDT), in the session entitled, "OA14 The Breakthrough Immunotherapy for Advanced NSCLC" (abstract #OA14.04). As previously communicated, the FDA has assigned a Prescription Drug User Fee Act goal action date of November 14, 2026, for Summit’s Biologics License Application for ivonescimab in combination with platinum-doublet chemotherapy for the treatment of patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose disease has progressed following treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI). About EGFR-Mutated NSCLC Lung cancer is the second most commonly diagnosed cancer worldwide and remains the leading cause of cancer-related death globally, with an estimated 2.6 million new cases and 1.9 million deaths in 2024.1 In the United States, the American Cancer Society estimates that approximately 230,000 new lung cancer cases will be diagnosed and nearly 125,000 deaths from lung cancer will occur in 2026.2 Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, representing approximately 80% to 85% of all cases.1,3 EGFR mutations are among the most common actionable oncogenic drivers in non-squamous NSCLC, occurring in approximately 10-15% of patients in western populations and 40-50% of patients in Asia.4,5 Activating EGFR mutations can drive tumor growth through aberrant EGFR signaling.6 EGFR tyrosine kinase inhibitors (TKIs), including third-generation EGFR TKIs, are an important treatment approach for patients with advanced EGFR-mutated NSCLC.4 Despite advances with EGFR-targeted therapy, most patients with locally advanced or metastatic EGFR-mutated NSCLC eventually experience disease progression after treatment with a third-generation EGFR TKI.7 In patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC previously treated with a third-generation EGFR TKI, treatment options remain limited, underscoring the need for new therapeutic approaches after progression on EGFR-targeted therapy.7 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 design 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 16 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, five 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 colorectal cancer (CRC) in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3. In 2026, Summit announced initiation of HARMONi-GU1, a Phase II/III study in urothelial carcinoma (bladder cancer) with global clinical trial site activations planned to begin by the fourth quarter of 2026. 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. HARMONi-GU1 is a Phase II/III clinical trial evaluating ivonescimab plus the antibody drug conjugate (ADC) enfortumab vedotin (EV) compared to pembrolizumab plus EV as first-line therapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). 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. Four Phase III ivonescimab clinical trials have read out to date, all four with positive data, in NSCLC. In addition to Summit’s positive HARMONi study, Akeso has 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. A manageable, consistent safety profile was achieved in each of these studies. 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 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. References Sung H, Filho AM, Siegel RL, Laversanne M, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2024: GLOBOCAN estimates of incidence and mortality worldwide for 34 cancers in 186 countries. CA Cancer J Clin. 2026. doi:10.3322/caac.70090. American Cancer Society. Lung Cancer Statistics: How Common Is Lung Cancer? Accessed August 20, 2026. American Cancer Society. What Is Lung Cancer? Types of Lung Cancer. Accessed August 20, 2026. National Cancer Institute. Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version. Accessed August 20, 2026. Midha A, Dearden S, McCormack R. EGFR mutation incidence in non-small-cell lung cancer of adenocarcinoma histology: a systematic review and global map by ethnicity (mutMapII). Am J Cancer Res. 2015;5(9):2892-2911. Pao W, Chmielecki J. Rational, biologically based treatment of EGFR-mutant non-small-cell lung cancer. Nat Rev Cancer. 2010;10(11):760-774. doi:10.1038/nrc2947. Zhou Q, Zhao H, Lu S, et al. Consensus on the lung cancer management after third-generation EGFR-TKI resistance. Lancet Reg Health West Pac. 2024;53:101260. doi:10.1016/j.lanwpc.2024.101260. 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/20260825415559/en/ Contacts Summit Therapeutics’ Media & Investor Contacts:Nathan LiaBraatenSenior Director, Investor Relations Tracy JonesDirector, Media & Public [email protected] [email protected]
Investor releaseQuarter not tagged2026-07-24Summit Therapeutics Inc (SMMT) Q2 2026 Earnings Call Highlights: Strong Cash Position and ...
GuruFocus.com
Summit Therapeutics Inc (SMMT) Q2 2026 Earnings Call Highlights: Strong Cash Position and ...
This article first appeared on GuruFocus. Release Date: July 23, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Summit Therapeutics Inc (NASDAQ:SMMT) reported a strong cash position of approximately $690.7 million at the end of Q2 2026, an increase from the previous quarter. Ivanizumab, the company's lead investigational asset, has shown positive data in four Phase III clinical studies, leading to two approvals in China and a pending BLA with the U.S. FDA. The HARMONY trial demonstrated a consistent overall survival benefit across different geographic regions, indicating the potential for global applicability. Summit Therapeutics Inc (NASDAQ:SMMT) has established collaborations with major pharmaceutical companies like GSK and Arcus Biosciences to explore novel combinations with Ivanizumab. The company has initiated over 50 clinical trials for Ivanizumab, covering a wide range of solid tumors, indicating a robust and diverse pipeline. The company reported an increase in GAAP operating expenses to $220.5 million in Q2 2026, primarily due to higher R&D expenses. Despite positive trial results, Ivanizumab has not yet achieved statistically significant overall survival benefits in some settings, which is necessary for FDA approval. The enrollment for some trials, such as HARMONY 3, was back-end loaded, potentially affecting the follow-up time and interim analysis results. There is a risk of competition from other emerging therapies like amivantamab and Trope 2 ADCs, which could impact Ivanizumab's market positioning. The company has no debt, but it relies heavily on ATM facilities for financing, which could pose risks if market conditions change. Warning! GuruFocus has detected 2 Warning Signs with SMMT. Is SMMT fairly valued? Test your thesis with our free DCF calculator. Q: Could you speak to the translatability of the recent overall survival results from the second-line EGFR study to other larger markets, specifically frontline non-small cell lung cancer? A: Dave Yankars, Chief Business and Strategy Officer, explained that maturity in follow-up time is critical for ivanescimab, a next-generation immunotherapy. The consistent magnitude of benefit observed with meaningful follow-up time in the recent study suggests that similar clinically meaningful results could be achieved in other frontline studies wi…Read full documentShow less
This article first appeared on GuruFocus. Release Date: July 23, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Summit Therapeutics Inc (NASDAQ:SMMT) reported a strong cash position of approximately $690.7 million at the end of Q2 2026, an increase from the previous quarter. Ivanizumab, the company's lead investigational asset, has shown positive data in four Phase III clinical studies, leading to two approvals in China and a pending BLA with the U.S. FDA. The HARMONY trial demonstrated a consistent overall survival benefit across different geographic regions, indicating the potential for global applicability. Summit Therapeutics Inc (NASDAQ:SMMT) has established collaborations with major pharmaceutical companies like GSK and Arcus Biosciences to explore novel combinations with Ivanizumab. The company has initiated over 50 clinical trials for Ivanizumab, covering a wide range of solid tumors, indicating a robust and diverse pipeline. The company reported an increase in GAAP operating expenses to $220.5 million in Q2 2026, primarily due to higher R&D expenses. Despite positive trial results, Ivanizumab has not yet achieved statistically significant overall survival benefits in some settings, which is necessary for FDA approval. The enrollment for some trials, such as HARMONY 3, was back-end loaded, potentially affecting the follow-up time and interim analysis results. There is a risk of competition from other emerging therapies like amivantamab and Trope 2 ADCs, which could impact Ivanizumab's market positioning. The company has no debt, but it relies heavily on ATM facilities for financing, which could pose risks if market conditions change. Warning! GuruFocus has detected 2 Warning Signs with SMMT. Is SMMT fairly valued? Test your thesis with our free DCF calculator. Q: Could you speak to the translatability of the recent overall survival results from the second-line EGFR study to other larger markets, specifically frontline non-small cell lung cancer? A: Dave Yankars, Chief Business and Strategy Officer, explained that maturity in follow-up time is critical for ivanescimab, a next-generation immunotherapy. The consistent magnitude of benefit observed with meaningful follow-up time in the recent study suggests that similar clinically meaningful results could be achieved in other frontline studies with appropriate follow-up times. Q: Can you provide more granularity on the timing for the final PFS and early interim OS look for Harmony 3 in the second half of this year? A: Dave Yankars noted that event rates have slowed down, and while they still expect to reach the number of events needed for the PFS analysis in the second half of this year, it is likely towards the middle to back end of 2026. The disclosure plan is not yet determined, but they expect to see a meaningful overall survival trend. Q: With the Harmony 3 survival analysis, will we get an overall survival hazard ratio at the interim analysis in the first half of next year? A: Dave Yankars confirmed that the first half of 2027 will be the first analysis independent of any pre-planned PFS analysis. The median follow-up is expected to be consistent with previous studies, providing a meaningful look at overall survival. Q: How do you think about the level of follow-up in the context of the interim OS readout for Harmony 3, given the separate squamous and non-squamous cohorts? A: Dave Yankars explained that the interim OS analysis in the second half of this year will support the PFS analysis. The first half of 2027 will provide a powered interim look at OS, with median follow-up time consistent with previous studies, allowing for a clearer picture of overall survival. Q: Could the updated Harmony data result in a major amendment and potential delay of the PDUFA date? How do you view the competitive positioning of ivanescimab? A: Dave Yankars stated that while the updated data has been submitted to the FDA, any decision on the PDUFA date or an ODAC panel is up to the agency. Regarding competitive positioning, ivanescimab offers a manageable safety profile and provides a different mechanism of action compared to other agents, offering physicians and patients more treatment options. For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2026-07-23Summit Therapeutics Q2 Earnings Call Highlights
MarketBeat
Summit Therapeutics Q2 Earnings Call Highlights
Interested in Summit Therapeutics PLC? Here are five stocks we like better. Updated HARMONi trial data showed a median follow-up improvement and an overall survival hazard ratio of 0.76 in both the total population and Western patients. Summit said it submitted the new results to the FDA, and the ivonescimab plus chemotherapy BLA remains under review with a Nov. 14 PDUFA date. Management outlined several late-stage trial milestones, including HARMONi-3, HARMONi-7, HARMONi-GI3 and other studies. The company expects key PFS and OS readouts to arrive from late 2026 through 2027, while additional collaboration programs with Revolution Medicines, GSK and Arcus are expanding the development pipeline. Summit ended Q2 with $690.7 million in cash and no debt, helped by ATM financing, but operating expenses rose as clinical trial spending increased. The company is also building commercial infrastructure ahead of a possible U.S. launch if ivonescimab is approved. Why Wall Street Is Backing These 3 Comeback Stocks Summit Therapeutics (NASDAQ:SMMT) executives used the company’s latest earnings call to emphasize updated survival data for ivonescimab, outline the timing of key late-stage trial readouts and detail the company’s cash position as it prepares for a potential U.S. regulatory decision later this year. Chairman and Co-Chief Executive Officer Bob Duggan said Summit remains focused on ivonescimab, its PD-1/VEGF bispecific antibody and lead investigational asset. Duggan said ivonescimab has produced positive data in four Phase III clinical studies to date, leading to two approvals in China, with one additional filing under review there. He said 15 Phase III trials are ongoing or have read out across multiple tumor types, and that Summit and partner Akeso have initiated 52 clinical trials evaluating the drug. → Could Truth API Become Trump Media’s First Meaningful Revenue Driver? MarketBeat Week in Review – 11/4 - 11/8 Duggan also said more than 4,000 patients have been dosed with ivonescimab in Summit- or Akeso-sponsored clinical trials globally, while more than 70,000 patients have received the drug commercially in China. President and Co-Chief Executive Officer Dr. Maky Zanganeh highlighted an updated overall survival analysis from the global Phase III HARMONi trial, which evaluated ivonescimab plus chemotherapy versus chemotherapy alone in patients with EGFR-muta…Read full documentShow less
Interested in Summit Therapeutics PLC? Here are five stocks we like better. Updated HARMONi trial data showed a median follow-up improvement and an overall survival hazard ratio of 0.76 in both the total population and Western patients. Summit said it submitted the new results to the FDA, and the ivonescimab plus chemotherapy BLA remains under review with a Nov. 14 PDUFA date. Management outlined several late-stage trial milestones, including HARMONi-3, HARMONi-7, HARMONi-GI3 and other studies. The company expects key PFS and OS readouts to arrive from late 2026 through 2027, while additional collaboration programs with Revolution Medicines, GSK and Arcus are expanding the development pipeline. Summit ended Q2 with $690.7 million in cash and no debt, helped by ATM financing, but operating expenses rose as clinical trial spending increased. The company is also building commercial infrastructure ahead of a possible U.S. launch if ivonescimab is approved. Why Wall Street Is Backing These 3 Comeback Stocks Summit Therapeutics (NASDAQ:SMMT) executives used the company’s latest earnings call to emphasize updated survival data for ivonescimab, outline the timing of key late-stage trial readouts and detail the company’s cash position as it prepares for a potential U.S. regulatory decision later this year. Chairman and Co-Chief Executive Officer Bob Duggan said Summit remains focused on ivonescimab, its PD-1/VEGF bispecific antibody and lead investigational asset. Duggan said ivonescimab has produced positive data in four Phase III clinical studies to date, leading to two approvals in China, with one additional filing under review there. He said 15 Phase III trials are ongoing or have read out across multiple tumor types, and that Summit and partner Akeso have initiated 52 clinical trials evaluating the drug. → Could Truth API Become Trump Media’s First Meaningful Revenue Driver? MarketBeat Week in Review – 11/4 - 11/8 Duggan also said more than 4,000 patients have been dosed with ivonescimab in Summit- or Akeso-sponsored clinical trials globally, while more than 70,000 patients have received the drug commercially in China. President and Co-Chief Executive Officer Dr. Maky Zanganeh highlighted an updated overall survival analysis from the global Phase III HARMONi trial, which evaluated ivonescimab plus chemotherapy versus chemotherapy alone in patients with EGFR-mutated non-small cell lung cancer after TKI therapy. → 3 Photonics Companies Making Quantum Tech Possible Summit Therapeutics: Is Their Lung Cancer Drug a Game Changer? Zanganeh said the latest analysis, with a June 2026 data cutoff, showed Western patients had reached a median follow-up of more than 23 months, while Asian patients remained at a median follow-up of 33 months. The company reported an overall survival hazard ratio of 0.76 in both the total population and the Western regional data. “The hazard ratio for Western patients has improved with more follow-up time,” Zanganeh said, adding that the Western results are now consistent with the magnitude of overall survival benefit seen in Asian patients, who had longer follow-up at the primary analysis. → AeroVironment’s Stock Is Down, But Drone Demand Is Taking Off Summit said no new safety signals were observed in the latest data cut, and that the safety profile remained acceptable and manageable, consistent with previous Phase III results of ivonescimab plus chemotherapy. Zanganeh said Summit has made the updated results available to the U.S. Food and Drug Administration. The company’s biologics license application for ivonescimab plus chemotherapy in the EGFR-mutated non-small cell lung cancer post-TKI setting remains under FDA review, with a target PDUFA date of Nov. 14. Zanganeh noted that the FDA has previously said a statistically significant overall survival benefit is necessary to support marketing authorization in this setting. Summit also provided updates on several global Phase III studies. HARMONi-3 is evaluating ivonescimab plus chemotherapy against pembrolizumab plus chemotherapy in first-line metastatic non-small cell lung cancer in both squamous and non-squamous histologies, which will be analyzed separately. Zanganeh said enrollment has been completed in both cohorts. Summit expects to reach the number of events needed for a progression-free survival analysis in the squamous cohort in the second half of this year, along with an early interim look at overall survival. The company expects a separate overall survival interim analysis in the first half of 2027. For the non-squamous cohort, Summit expects to reach the number of events for a progression-free survival analysis in the first half of 2027. In the question-and-answer session, Chief Business and Strategy Officer Dave Gancarz said the HARMONi-3 squamous PFS timing is likely “towards the middle to back end of 2026,” rather than in the near term. He said the first-half 2027 overall survival analysis should have median follow-up generally consistent with the HARMONi-6 analysis and the updated Western patient data from HARMONi. Summit said HARMONi-7, which compares ivonescimab monotherapy against pembrolizumab monotherapy in first-line non-small cell lung cancer with high PD-L1 expression, continues to enroll. HARMONi-GI3 is evaluating ivonescimab plus chemotherapy versus bevacizumab plus chemotherapy as first-line therapy in unresectable colorectal cancer. Zanganeh also reviewed Summit’s collaborations with Revolution Medicines, GSK and Arcus Biosciences. The Revolution Medicines collaboration began enrolling in the first quarter and is evaluating ivonescimab with three novel RAS inhibitors across solid tumor settings including pancreatic, colorectal and non-small cell lung cancers. Summit expects its GSK collaboration, which will evaluate ivonescimab with GSK’s B7-H3 antibody-drug conjugate in multiple solid tumors, to enroll its first patient later this quarter. The company also announced a collaboration with Arcus to evaluate ivonescimab with Arcus’ HIF-2α inhibitor casdatifan in first-line metastatic clear cell renal cell carcinoma. Summit expects initial data from that collaboration by mid-next year. The company also pointed to ILLUMINE, a Phase III head and neck cancer study sponsored by European cooperative group GORTEC, which is enrolling in Europe and is expected to begin in China later this year. Chief Operating Officer and Chief Financial Officer Manmeet Soni said Summit ended the second quarter of 2026 with $690.7 million in cash, up from $598.7 million at the end of the first quarter. Soni attributed the $92 million increase primarily to $231 million raised through the company’s at-the-market facility, partially offset by approximately $140 million used in operating activities during the quarter. Soni said Summit filed a prospectus supplement for a new ATM facility of up to $380 million to provide additional financing flexibility. He also said the company currently has no debt on its balance sheet. Total GAAP operating expenses were $220.5 million in the second quarter, compared with $195.2 million in the first quarter. Non-GAAP operating expenses, which exclude stock-based compensation, were $151.8 million, compared with $122.4 million in the prior quarter. Soni said the increase was primarily driven by higher research and development expenses related to clinical trial costs for HARMONi-GI3, HARMONi-3 and HARMONi-7. In response to an analyst question, Soni said Summit is preparing for a possible U.S. commercial launch ahead of the Nov. 14 PDUFA date. He said the company has hired its commercial leadership team, market access staff and marketing personnel, while field force hiring would typically occur closer to the regulatory date. Gancarz added that the company has also ramped up medical science liaisons. Duggan closed the call by reiterating management’s confidence in ivonescimab. “We know that ivonescimab works,” he said. “The question I leave you with is, what if ivonescimab works really well?” Summit Therapeutics plc is a clinical‐stage biotechnology company dedicated to the discovery and development of precision medicines for serious and life‐threatening diseases. The company applies a targeted approach to drug design, focusing on novel mechanisms of action that differentiate its candidates from existing therapies. Summit's lead asset, ridinilazole (formerly SMT19969), is being developed to treat Clostridioides difficile infections and has received both Fast Track and Qualified Infectious Disease Product designations from the U.S. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Summit Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for July 2026.
Investor releaseQuarter not tagged2026-07-23Summit Therapeutics Reports Financial Results and Operational Progress for the Second Quarter and Six Months Ended June 30, 2026
Business Wire
Summit Therapeutics Reports Financial Results and Operational Progress for the Second Quarter and Six Months Ended June 30, 2026
Consistent Overall Survival Observed in Western, Asian Patients in Updated Analysis from Phase III HARMONi Study in EGFRm NSCLC Post-TKI Setting for Ivonescimab Plus Chemotherapy vs. Chemotherapy Ivonescimab Plus Chemotherapy Achieves Statistically Significant and Clinically Meaningful Overall Survival Benefit in 1L Squamous NSCLC HARMONi-6 Trial Conducted in China, the First Phase III Head-to-Head Clinical Study to Demonstrate Superiority over an Anti-PD-(L)1 Antibody-Containing Regimen HARMONi-3 Global Phase III 1L NSCLC Study: Squamous Cohort Final PFS Analysis Events Expected to Be Reached in Second Half of 2026 with Interim OS Analyses Planned; Non-Squamous Cohort PFS Events Expected to Be Reached in the First Half of 2027 Summit Closes Second Quarter with $690.7 Million in Cash and Investments MIAMI, July 23, 2026--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) today reported its financial results for the second quarter and six months ended June 30, 2026 and provided an update on clinical and operational progress. "The clinical momentum of ivonescimab continues to build, with two recent key data readouts that significantly bolster our development progress. At ASCO, the landmark HARMONi-6 results established the first head-to-head Phase III study in any tumor type to demonstrate a meaningful overall survival advantage over anti-PD-1 inhibitors in combination with chemotherapy, representing an important milestone for cancer patients and for the broader immuno-oncology field," said Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit. "This was followed by updated overall survival data from the HARMONi trial, in which western patients replicated the survival benefit seen in Asian patients and further reinforces our confidence in the regional consistency of the efficacy results of ivonescimab." "These new data continue to demonstrate the differentiated profile of ivonescimab," said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit. "In HARMONi-6, we saw an outcome that underscores the potential impact of our bispecific PD-1 / VEGF program. Equally important, the updated HARMONi overall survival analysis provided additional evidence of consistency of efficacy outcomes across patient populations. We also presented encouraging Phase II colorectal cancer data at ASCO that adds to the growing body of evidence support…Read full documentShow less
Consistent Overall Survival Observed in Western, Asian Patients in Updated Analysis from Phase III HARMONi Study in EGFRm NSCLC Post-TKI Setting for Ivonescimab Plus Chemotherapy vs. Chemotherapy Ivonescimab Plus Chemotherapy Achieves Statistically Significant and Clinically Meaningful Overall Survival Benefit in 1L Squamous NSCLC HARMONi-6 Trial Conducted in China, the First Phase III Head-to-Head Clinical Study to Demonstrate Superiority over an Anti-PD-(L)1 Antibody-Containing Regimen HARMONi-3 Global Phase III 1L NSCLC Study: Squamous Cohort Final PFS Analysis Events Expected to Be Reached in Second Half of 2026 with Interim OS Analyses Planned; Non-Squamous Cohort PFS Events Expected to Be Reached in the First Half of 2027 Summit Closes Second Quarter with $690.7 Million in Cash and Investments MIAMI, July 23, 2026--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) today reported its financial results for the second quarter and six months ended June 30, 2026 and provided an update on clinical and operational progress. "The clinical momentum of ivonescimab continues to build, with two recent key data readouts that significantly bolster our development progress. At ASCO, the landmark HARMONi-6 results established the first head-to-head Phase III study in any tumor type to demonstrate a meaningful overall survival advantage over anti-PD-1 inhibitors in combination with chemotherapy, representing an important milestone for cancer patients and for the broader immuno-oncology field," said Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit. "This was followed by updated overall survival data from the HARMONi trial, in which western patients replicated the survival benefit seen in Asian patients and further reinforces our confidence in the regional consistency of the efficacy results of ivonescimab." "These new data continue to demonstrate the differentiated profile of ivonescimab," said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit. "In HARMONi-6, we saw an outcome that underscores the potential impact of our bispecific PD-1 / VEGF program. Equally important, the updated HARMONi overall survival analysis provided additional evidence of consistency of efficacy outcomes across patient populations. We also presented encouraging Phase II colorectal cancer data at ASCO that adds to the growing body of evidence supporting the potential of ivonescimab as a differentiated PD-1 / VEGF bispecific antibody across tumor types. We believe these results meaningfully strengthen the overall body of evidence supporting ivonescimab and provide important validation as we advance our global development program across multiple solid tumors." Clinical & Operational Updates Clinical and 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: Summit in-licensed ivonescimab from Akeso Inc. (Akeso, HKEX Code: 9926.HK) in January 2023. In total, over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 70,000 patients have been treated in the commercial setting with ivonescimab in China, as noted and updated by Akeso. Summit has exclusive 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 In January 2026, the U.S. Food and Drug Administration (FDA) 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 BLA was submitted based on the overall results of the global Phase III HARMONi trial. The FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026. In July 2026, Summit announced results of a new updated overall survival (OS) analysis from the HARMONi study, which showed a consistent OS trend amongst western and Asian patients as western patients were followed for additional time on study. These encouraging results provide further evidence of the geographic translatability of ivonescimab across the globe, including western patients from North America and Europe. In this new analysis, western patients increased their time on study, reaching a median follow-up of 23.2 months; Asian patients remained locked with a median follow-up time of 32.7 months. A hazard ratio of 0.76 was observed for the full ITT population; the same 0.76 hazard ratio was observed in both Asian and western patient subgroups, respectively, in this analysis. Ivonescimab continued to demonstrate an acceptable and manageable safety profile that was consistent with previous Phase III data of ivonescimab plus chemotherapy. No additional safety signals were observed. These results have been made available to the FDA, and more detailed data are intended to be presented at an upcoming medical meeting. HARMONi-3 Enrollment in both the squamous and non-squamous NSCLC cohorts of the global HARMONi-3 study is now complete. The number of PFS events needed in the squamous cohort for the primary analysis is expected to be reached in the second half of 2026, and a planned early interim analysis for OS is expected to take place in conjunction with the primary PFS analysis. An interim analysis for overall survival independent of PFS is planned for the first half of 2027. For the non-squamous cohort, the number of events needed to conduct the PFS analysis is expected to be reached in the first half of 2027. Additional Ivonescimab Development Updates Summit's global Phase III trials HARMONi-7 and HARMONi-GI3 continue to enroll. In addition to the multiregional studies conducted and sponsored by Summit, Akeso is 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 (HNSCC), small cell lung cancer, colorectal cancer, and pancreatic cancer. Summit plans to continue further expansion of the global clinical development program for ivonescimab, including additional Phase III studies, in additional settings and tumor types. The company will continue to provide more details in the coming months with respect to additional Phase III studies evaluating ivonescimab beyond NSCLC, CRC, and HNSCC. Summit’s clinical trial collaborations continue to progress as planned. Clinical trial collaborations and investigator sponsored trials (ISTs) with leading academic organizations, including MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and Dana Farber Cancer Institute, among others, continue to progress and expand evaluating ivonescimab in solid tumors. Summit is currently supporting more than 65 ISTs, of which 24 are actively enrolling. In July 2026, Summit sold ridinilazole, an investigational Phase III precision antibiotic asset, to Biossil, Inc. Under the terms of the agreement, Summit will receive $500,000 upfront and up to $104.5 million in regulatory and commercial milestones, plus tiered royalties on net sales. Financial Highlights Cash and Cash Equivalents and Short-Term Investments Aggregate cash and cash equivalents and short-term investments were $690.7 million and $713.4 million at June 30, 2026 and December 31, 2025, respectively. During the second quarter of 2026, the company raised $230.8 million in gross proceeds through its ATM facility. Subsequent to June 2026, the company raised an additional $68.4 million in gross proceeds through its ATM facility. GAAP and Non-GAAP Operating Expenses GAAP operating expenses were $220.5 million for the second quarter of 2026, compared to $568.4 million for the same period of the prior year. The decrease in GAAP operating expenses was due to the decrease in stock-based compensation expense of $410.1 million primarily related to the modification to the company’s performance-based stock option awards during the second quarter of 2025. Non-GAAP operating expenses were $151.8 million for the second quarter of 2026, compared to $89.6 million for the same period of the prior year. The increase in Non-GAAP operating expenses was primarily driven by the 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 $157.7 million for the second quarter of 2026, compared to $208.0 million for the same period of the prior year. The decrease was due to the decrease in stock-based compensation expense of $104.5 million primarily related to the modification to the company’s performance-based stock option awards during the second quarter of 2025. Non-GAAP R&D expenses were $133.6 million for the second quarter of 2026, compared to $79.4 million for the same period of the prior year. The increase was primarily driven by the initiation of new clinical trials and expansion of current clinical trials from last year. GAAP and Non-GAAP General and Administrative (G&A) Expenses GAAP G&A expenses were $62.8 million for the second quarter of 2026, compared to $360.4 million for the same period of the prior year. The decrease was due to the decrease in stock-based compensation expense of $305.6 million primarily related to the modification to the company’s performance-based stock option awards during the second quarter of 2025. Non-GAAP G&A expenses were $18.2 million for the second quarter of 2026, compared to $10.2 million for the same period of the prior year. The increase was primarily driven by the expansion of infrastructure and headcount to support the development of ivonescimab. GAAP and Non-GAAP Net Loss GAAP net loss in the second quarter of 2026 and 2025 was $215.7 million or $(0.28) per basic and diluted share, and $565.7 million or $(0.76) per basic and diluted share, respectively. Non-GAAP net loss in the second quarter of 2026 and 2025 was $147.0 million or $(0.19) per basic and diluted share, and $86.9 million or $(0.12) 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. 5 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. Second Quarter 2026 Earnings Call Summit will host an earnings call this afternoon, Thursday, July 23, 2026, at 4:30 p.m. EDT. The conference call will be accessible by dialing (833) 461-5787 (toll-free domestic) or (626) 884-3620 (international) using conference code 160295291. Listeners are encouraged to join the live webcast, which is accessible through Summit’s website at www.smmttx.com, as slides will be displayed simultaneously. The archived webcast will be available 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 design 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 colorectal cancer (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 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 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. 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 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.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 arrangements. View source version on businesswire.com: https://www.businesswire.com/news/home/20260723317187/en/ Contacts Contact Summit Investor Relations: Nathan LiaBraatenSenior Director, Investor Relations Tracy JonesDirector, Media & Public Relations [email protected] [email protected]
TranscriptFY2026 Q22026-07-23FY2026 Q2 earnings call transcript
Earnings source - 106 paragraphs
FY2026 Q2 earnings call transcript
Archived replay will also be made available later today on our website. Joining me on the call today is Bob Duggan, our Chairman of the Board and Co-Chief Executive Officer, Dr. Maky Zanganeh, our President and Co-Chief Executive Officer, Manmeet Soni, our Chief Operating Officer and Chief Financial Officer, and Dr. Allen Yang, Chief of R&D Strategy. I'm Dave Gancarz, the Chief Business and Strategy Officer here at Summit. Before we get started with the rest of the call, I would like to note that some statements made by our management team and some responses to questions that we make today may be considered forward-looking statements based on our current expectations. Summit cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements.
Please refer to our SEC filings for information, including the Form 10-Q issued today, about these risks and uncertainties. Summit undertakes no obligation to update these forward-looking statements except as required by law. One item of note, this presentation is being webcast with slides, so we'll be referring to the slides being displayed in the web link. I'd encourage you to use the webcast link to see the slides being presented this afternoon that will accompany our comments. Following comments from our team, we will take questions. With that, I'll hand it over to Bob.
Thank you, Dave. Good afternoon, everyone. Thank you for joining us today. I'm very proud of the highly focused, mission-driven, patient-first team at Summit and their growing physician support around ivonescimab, our PD-1, VEGF, bispecific, and lead investigational asset. In addition, we continue to appreciate Big Pharma's high interest in ivonescimab as the backbone of combination therapy in many different solid tumor settings. As we look to successfully combine ivonescimab with their innovative new targets, our team continues to grow in number and ability as we expand our clinical development plan and prepare for commercialization in anticipation of a decision from the FDA on our BLA toward the end of this year.
Before we start with key updates from the past couple of months, I'd like to take a moment to remind those of you who have been with us from the beginning and introduce to those of you who may be new to the story of what ivonescimab has accomplished to date. You can see this on slide three. Ivonescimab has read out four phase III clinical studies to date, all four with positive data. This has led to two approvals in China so far, with one currently under review. In addition to the pending BLA with the U.S. FDA, a total of 15 phase III trials are currently ongoing or have read out in multiple tumor types. Between Summit and our partners at Akeso, 52 clinical trials have been initiated evaluating ivonescimab in a variety of solid tumors.
When including investigator-initiated and collaborative studies, a total of 171 clinical trials are now listed on clinicaltrials.gov. The enthusiasm demonstrated by investigators around the world to generate data and sync positive signals for patients facing high-end medical need really speaks to the opportunity and ever-present optimism surrounding ivonescimab. Together with Akeso, over 4,000 patients in either Summit-sponsored or Akeso-sponsored clinical trials across the world have been dosed with ivonescimab. Commercially, in China, over 70,000 patients have been administered ivonescimab. On slide four, we see a snapshot of the current ivonescimab development plans across Summit and Akeso, as well as a phase III clinical trial sponsored by prominent European cooperative group, GORTEC. Our collective pipelines cover not only multiple settings in lung and colorectal cancers, but also head and neck, breast, biliary, pancreatic, gynecological, gastric, and hepatocellular cancer, including non-metastatic settings.
Summit's announced phase III studies focus on non-small cell lung cancer and colorectal cancer, and these studies represent only a subset of ivonescimab's potential future indications, as you can see here. Through our wonderful partnership with Akeso, data generated in our studies, as well as data generated through investigator-sponsored trials, we continuously consider evolving ivonescimab to drive more informed as well as faster decisions, all of which support efficient and timely expansion of our global ivonescimab development plan. I'll now turn it over to Maky to discuss some of the recent developments. Maky?
Thank you, Bob. Yesterday, we announced an updated OS analysis conducted for our global phase III HARMONi trial. The HARMONi study evaluated ivonescimab plus chemo against chemo alone as a treatment for EGFR-mutated non-small cell lung cancer after TKI therapy, a patient population of significant unmet need with few available treatment options. In this most recent analysis, with a data cutoff in June 2026, Western patients increased their time on study, reaching a median follow-up of over 23 months. Asian patients remained locked with a median follow-up time of 33 months. A hazard ratio of 0.76 was observed in both the total population as well as the regional Western data. The hazard ratio for Western patients has improved with more follow-up time.
With longer follow-up, results of Western patients are now consistent in terms of the magnitude of OS benefit with those patients enrolled in Asia who had a longer follow-up at the time of their primary OS analysis. Ivonescimab continued to demonstrate an acceptable and manageable safety profile that was consistent with previous phase III results of ivonescimab plus chemo. No additional safety signals were observed in this current HARMONi data cut compared to the previous data cuts. As a reminder, this setting is one in which multiple PD-1 inhibitors have failed previously to show a benefit in either PFS or OS. Prior phase III studies were conducted in this setting individually with pembro or nivo, each in combination with chemo and were not successful. In addition, there are currently no approved agents in this setting which have demonstrated an overall survival benefit compared to chemo alone.
The encouraging result from this long-term overall survival analysis continue to support the ability to translate the therapeutic profile of ivonescimab across the globe, including the efficacy potential of ivonescimab in Western patients from North America and Europe. This data shows a consistent favorable OS trend across geographies as Western patients were followed for additional time on study. With meaningful follow-up time in both regions, the magnitude of the OS benefit is consistent between patients enrolled in China and enrolled in Western countries, including the United States, in the HARMONi study. We intend to provide exciting additional details from this new long-term analysis at a future medical meeting. We have also made these results available to the FDA. As previously disclosed, the FDA noted that a statistically significant overall survival benefit is necessary to support marketing authorization in this setting.
Considering the safety and efficacy profile of the current FDA-approved options for patients in this setting, none of which have demonstrated a statistically significant OS benefit, as well as the continued positive regionally consistent data of this phase III multi-regional study and discussions with key opinion leaders and physicians who have administered ivonescimab to patients, we believe that ivonescimab is a potential treatment option with favorable benefit risk profile. Turning specifically to Summit's global ivonescimab pipeline, which is noted on slide seven, we have four phase III trials completed or ongoing. HARMONi, which we just covered, HARMONi-3, HARMONi-7, and HARMONi-GI3. HARMONi-3 is evaluating ivonescimab plus chemo against pembro plus chemo in first-line metastatic non-small cell lung cancer in both patients with squamous and non-squamous histologies, each of which will be analyzed separately.
These patient populations represent a significant unmet medical need, with the nearly 100,000 patients in the United States alone as this trial covers first-line non-small cell lung cancer patients without genomic alterations. In line with prior guidance, we have completed enrollment in both the squamous and non-squamous cohorts. We expect to reach the number of events needed to conduct a PFS analysis for the squamous cohort in the second half of this year, which would also come with a corresponding early interim look at overall survival. We would expect to reach the number of events for the first look at OS that is independent of the PFS analysis in the first half of 2027. For the non-squamous cohort, we expect to reach the number of events needed to conduct a progression-free survival analysis in the first half of 2027.
HARMONi-7 is evaluating ivonescimab monotherapy against pembro monotherapy as first-line treatment for patients with non-small cell lung cancer that has high PD-L1 expression levels. Enrollment continues to be strong, and we look forward to providing additional updates on this trial in the near future. HARMONi-GI3 evaluates ivonescimab plus chemo compared to beva plus chemo as first-line therapy in patients with unresectable colorectal cancer. Our decision to initiate this study was driven by encouraging phase II data published at ESMO 2024 and supported by global phase II data presented in Q2 of this year at ASCO 2026. We look forward to providing further updates as this global phase III colorectal cancer trial progresses. In addition to our sponsored studies, the phase III study, ILLUMINE, is currently enrolling in head and neck cancer through a European cooperative group, GORTEC.
This is another multi-regional phase III study that tests ivonescimab with and without an anti-CD47 agent head to head against pembro in an additional tumor setting from our historical work. The trial is enrolling in Europe, is intended to start in China later this year, and we will evaluate opening sites in the U.S. based on continued progress. Additionally, we have over 65 ISTs that we intend to support in various stages of development. Of these, 24 are currently enrolling and more publication on being featured at each major medical conference, often in prominent session at ASCO, ESMO, and World Conference on Lung Cancer. Through this combined research, ivonescimab has now been featured in over 50 publications, presentations, and posters. I would like to take a minute to focus on some of the clinical trial collaboration in which we have entered to evaluate ivonescimab with novel combinations.
Clinical development of ivonescimab in additional tumor settings also continues to progress as planned via our collaborations with RevMed, GSK, and now with Arcus. With respect to novel combinations, our collaboration with Revolution Medicines began enrolling in the first quarter of this year. This collaboration evaluates ivonescimab in combination with three novel RAS inhibitors across multiple solid tumor settings, including pancreatic, colorectal, and non-small cell lung cancers. We are enthusiastic about the opportunity of ivonescimab with multiple existing RAS inhibitors and what the combination has the potential to do for patients facing difficult-to-treat cancers. Our GSK collaboration evaluating ivonescimab in multiple solid tumor settings in combination with their B7-H3 ADC is expected to enroll its first patient later this quarter.
This is another example of promising targets seeking to significantly advance outcomes in settings such as multiple types of lung cancer and colorectal cancer, where both ivonescimab and B7-H3 ADCs have shown promise. We are also pleased to announce yesterday that we have established a collaboration with Arcus Biosciences to evaluate ivonescimab in combination with Arcus HIF-2α inhibitor, casdatifan, in first-line metastatic clear cell renal cell carcinoma, the most common form of kidney cancer. This combination presents a compelling opportunity for a potentially well-tolerated TKI-sparing option to prolong survival in this setting. We expect initial data from this collaboration to be generated by mid-next year. Collectively, these trials enhance and inform our own clinical development activities as we learn more about new settings where neither we nor Akeso have yet had the opportunity to explore. Additionally, the continued enthusiastic interest in ISTs is a testament for the optimists.
We have heard from many investigators as they consider the potential opportunity that ivonescimab presents across multiple tumor types and in multiple novel combinations regimens. Let's take a closer look at the clinical data we have seen from ivonescimab today, focusing on OS results. Of the four phase III studies that have read out to date, all four studies had positive, statistically significant, clinically meaningful progression-free survival results. In each of these studies, ivonescimab has achieved overall survival hazard ratios less than the generally accepted clinical meaningfulness threshold of 0.80. We discussed the updated data from the global HARMONi study earlier. We look forward to presenting additional details such as Kaplan-Meier curves, medians, and other important components of the analysis at an upcoming medical conference.
While not achieving statistical significance at the primary OS analysis, the nominal P-value implies significance of the OS benefit for the global study, and this is further supported by the updated OS data announced yesterday. The HARMONi-A study in China, in a similar setting to HARMONi, produced consistent results and demonstrated a statistically significant benefit in OS. HARMONi-2, conducted in China, which was the first time a phase III clinical trial has shown a statistically significant improvement in progression-free survival, directly replaced a PD-1 inhibitor in head-to-head setting, reported an overall survival hazard ratio of 0.78 at just 39% data maturity. This study evaluated ivonescimab monotherapy against pembro monotherapy as frontline treatment for patients with non-small cell lung cancer, whose tumors have positive PD-L1 expression, a similar patient population to Summit global phase III HARMONi-7 study, which focuses on tumors with high PD-L1 expression.
Finally, the HARMONi-6 study conducted in China achieved an overall survival hazard ratio of 0.68, as announced at the plenary session of ASCO 2026. The magnitude of benefit measured by the hazard ratio for OS was consistent with the benefit for PFS, both with hazard ratios in the 0.6. Again, this study compared ivonescimab with chemo against an anti-PD-1 plus chemo as frontline treatment for patients with non-small cell lung cancer of squamous histology. This is the first time a phase III clinical trial in any tumor type, not just in non-small cell lung cancer, has shown a statistically significant improvement in overall survival compared to a PD-1 inhibitor in combination with chemo in head-to-head setting. Four phase III studies have been conducted in three different non-small cell lung cancer settings, all producing clinically meaningful overall survival hazard ratios under 0.80.
Two of the four studies were conducted head-to-head against a PD-1 inhibitor, with or without chemotherapy, and two were conducted in settings where PD-1 inhibitors are not approved because they failed in past phase III clinical studies. These results speak to the opportunity to replace current immunotherapy options with ivo, the potential next generation of cancer therapy. As we have said before, we feel the data speaks for themselves and support immense potential for ivonescimab to help patients with lung cancer, and we believe in additional tumor settings as well as more data is generated and accumulates across Summit and Akeso trials, ISTs, and collaborations. Turning to slide nine and looking to the existing next steps for ivonescimab, our global phase III HARMONi-3 all-comers trial evaluating ivonescimab with chemo in frontline non-small cell lung cancer has completed enrollment in both the squamous and non-squamous cohorts.
We expect to reach the number of event for the primary PFS analysis for the squamous cohort in the second half of this year, which would come with a corresponding interim look at overall survival. Importantly, we expect to have another interim look at OS in first half of 2027, which will have additional follow-up time, something we continue to note as an important factor in showing the value of ivonescimab in these clinical studies. For the non-squamous cohort, we expect to reach the number of events for the PFS analysis in the first half of 2027. Turning to our BLA filing based on our phase III HARMONi study, seeking approval for ivonescimab plus chemo in the EGFR mutated non-small cell lung cancer setting post-TKI therapy. The submission is currently under review with the U.S. FDA. The agency has provided a target PDUFA date of November 14 of this year.
We continue to grow our commercial capabilities as we prepare in anticipation of ivonescimab's potential first U.S. approval and potential launch later this year. We will continue to provide further details on additional new global studies throughout the year, as they are ready to share. To date, we have initiated global phase III studies in non-small cell lung cancer, colorectal cancer, to our partnership with GORTEC head and neck squamous cell carcinoma. We look forward to continuing to grow our global pipeline, explore ivonescimab's potential to help additional patients in new tumor types and settings in the near future. On today call, we have covered ivonescimab recent accomplishments in the clinic, but as a reminder, this is only the beginning of a vast potential market opportunity for ivonescimab across solid tumors. We have discussed this previously, but with each successful data set, it becomes closer to reality.
Ivonescimab has the potential to be a platform blockbuster drug. Ivonescimab is well-positioned to make a significant impact across the solid tumor treatment landscape between checkpoint inhibitors and anti-VEGF therapies. The estimated total addressable market is in excess of $100 billion globally. Looking only at the checkpoint inhibitor market for non-small cell lung cancer, in which our first set of registrational phase III studies are conducted, market estimates for immunotherapy itself are expected to exceed $20 billion per year by 2028. On slide 10, we identify the more than 50 solid tumor settings where anti-PD-1, anti-VEGF therapies are approved. Established PD-1 and PD-L1 indications in green, and anti-VEGF indication in purple. The settings highlighted in yellow represent the indications we are currently running global phase III trials for ivonescimab, lung and colorectal cancers.
Clearly, there are several additional opportunities for ivonescimab beyond today PD-1 or VEGF landscape, including novel settings such as EGFR mutant lung cancer. We intend to provide details regarding additional studies, including phase III studies, in the near term. Ivonescimab differentiated profile, as we saw with HARMONi-6, achieving a statistically significant, highly clinically meaningful progression-free survival and overall survival benefit, alongside the updated global HARMONi data, support its platform potential across multiple indication, many of which could be blockbuster opportunities on their own. We have only just begun to see the potential of ivonescimab to help patients with solid tumors. These are exciting times at Summit, and we encourage you to follow our journey closely as we continue to expand the ivonescimab clinical development plan in a new tumor setting. Now I will turn the call over to Manmeet to provide a financial update. Manmeet?
Thank you, Maky, and good afternoon, everyone. On the financials front, let me start with our cash position. We ended the second quarter of 2026 with a strong cash position of approximately $690.7 million, as compared to $598.7 million at the end of first quarter of 2026. This increase of $92 million in cash position for the quarter is primarily due to the $231 million cash raised from our ATM facility, offset by the cash used in our operating activities of approximately $140 million for the second quarter of 2026. Consistent with our financing strategy in the past, earlier today, we also filed a prospectus supplement for a new ATM facility up to $380 million to provide us with additional flexibility for financing, both with respect to mechanism and timing. And finally, to remind everyone, currently, we have no debt on our balance sheet.
Turning to operating expenses, I will provide details on both GAAP and non-GAAP numbers. You can refer to our press release issued earlier today for a reconciliation of GAAP to non-GAAP financial measures. As a reminder, non-GAAP expenses exclude stock-based compensation expense. Total GAAP operating expenses for the second quarter of 2026 were $220.5 million compared to $195.2 million for the first quarter of 2026. The increase in GAAP operating expense was primarily due to an increase in our R&D expenses related to clinical trial expenses for HARMONi-GI3, HARMONi-3, and HARMONi-7. Overall, our non-GAAP operating expenses during the second quarter of 2026 were $151.8 million compared to $122.
$0.4 million for the first quarter of 2026. This increase in non-GAAP operating expenses was primarily related to an increase in R&D expenses, as previously mentioned. With that, I will turn the call back over to Dave. Dave?
Thank you, Manmeet. We will now see if there are any questions. Operator, if you could please open the line for those questions.
We will now begin the question-and-answer session. Please limit yourself to one question and one follow-up. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question is from Yigal Nochomovitz with Citigroup. Go ahead.
Hi. Great. Thank you very much for taking the questions. Very interesting recent updated overall survival cut from the second-line EGFR study. I am wondering if you could speak to the translatability of that conclusion in terms of equivalence on OS across geographies when thinking about some of the other larger markets, specifically, of course, frontline non-small cell lung cancer. Could you talk about how you think those OS results could translate to those other settings, please? Thank you.
Sure. Thanks, Yigal, and appreciate the question. This is Dave. I think in terms of takeaways and learnings, maturity in follow-up time is critical, in particular for ivonescimab as a next-generation immunotherapy. As we think about the translatability, what we saw is with meaningful follow-up time, there was consistent magnitude of benefit of overall survival. That's particularly important when we think about the difference between what we saw at the primary analysis in HARMONi versus what we saw published yesterday. When we take that to the other frontline studies, we have an opportunity now to show a magnitude of benefit that is clinically meaningful, in those studies as well, with the appropriate follow-up time, specifically for overall survival. If you recall, HARMONi-6 had an overall survival median follow-up, or a median follow-up time rather of 21 months in its overall survival analysis.
The recent data that we published yesterday for HARMONi, the Western patients now have 23 months approximately of median follow-up time. As we look at what that means overall, it's important globally to have consistent follow-up time that's meaningful across both, so that not necessarily equal to each other, but meaningful for all regions. We expect the ability to translate clinically meaningful results in China to clinically meaningful results across the globe with meaningful follow-up time.
Okay, thanks. Just one quick follow-up, if I may, on HARMONi-3. Can you provide any more granularity on the timing within the second half of this year for the final PFS? With the early interim OS look, is this going to be a qualitative comment, or are you going to be able to perhaps give a very early hazard ratio? If you could speak to that, please.
Yeah, absolutely. I think with respect to timing, as we enter the second half of 2026, we have a little bit of a clearer view on event rates and are providing more precise language with respect to expectations here for disclosures. In general, event rates have slowed down a little bit. We still expect to reach the number of events needed for the PFS analysis in the second half of this year. That timing is not next month, and it is going to be likely towards the middle to back end of 2026, and that's why we're a little bit more precise within the press release itself. With respect to the actual disclosure itself, I don't know that we have a specific disclosure plan set, but I think what we would expect is a directional trend from that data.
Again, not necessarily a determined disclosure plan. What we do expect is an ability to meaningfully take away the opportunity of what overall survival will show in this study. Again, recall the fact that with 22, 23 months of overall survival or follow-up time in an overall survival analysis, we've shown meaningful data in HARMONi-6 in China, and then the global HARMONi data; the Western patients with meaningful follow-up time showed that benefit. The follow-up time will be important there to get a full clear picture. We do expect to see an overall survival trend that is meaningful to us when we look at it later on.
Great. Thank you.
The next question comes from the line of Tyler Van Buren with TD Cowen. Tyler, your line is open. Please go ahead.
Great. Thanks very much. This is Nick on for Tyler. With the HARMONi-3 survival analysis, the interim survival analysis in the first half of next year, will we get an overall survival hazard ratio potentially at this point? If so, what will be the median follow-up as we think about what the bar should be and how it could progress over time, just like we saw with the Western population in the HARMONi trial? Thanks.
That's a fair question, Nick, and appreciate it. I think with respect to the additional overall survival interim analysis looked at in the first half of 2027, that gets closer to the median follow-up times that we saw with the HARMONi-6 OS analysis, as well as the western patients that we disclosed yesterday. I think that piece in particular, when we look at the first half 2027, that's really the first analysis that is independent of any pre-planned PFS analysis. That's why it was important, we felt, to call that out specifically in Maky's prepared remarks as well as our press release. That additional OS analysis, we used that first analysis that's not directly linked to a PFS analysis.
From a follow-up time perspective, we would expect that to be in the first half of 2027, the median follow to be consistent with what we saw for HARMONi-6 as well as for the HARMONi western data that we talked about yesterday.
Very good. Thanks.
Your next question is from the line of Salveen Richter with Goldman Sachs. Your line is open. Please go ahead.
Thank you. Good afternoon. Following up with the last questions, given the split of the study into separate squamous and non-squamous cohorts and that enrollment was overall back-end loaded, how do we think about the level of follow-up in the context of the interim OS readout? If statistical significance is not seen at the interim, in your view, what level of OS benefit would support or trend here would support a statistically significant final OS result?
Yeah. Thanks, Salveen, for the question. I want to just clarify a couple of points. We'll hit the number of events, or we expect to hit the number of events for a PFS analysis sometime in the second half of this year. That will be accompanied by a supporting OS analysis, and that would be an interim. In the first half of 2027, that would also be an interim OS analysis. The final OS, as would be consistent with frontline studies, would be a ways out. What I would expect that we see when we look at the analysis in the second half of this year would be one that supports the curve splitting for survival.
A beginning look at overall survival that we would expect if we look and we compare when the curves split for HARMONi 6, that's a good indication in terms of what we would be looking to see. That'll be early, and that's really supportive of PFS. We look at many trials when they run a primary PFS analysis have a supporting OS look. We look in the first half of 2027, that now has median follow-up time consistent with what we saw, again, in the HARMONi analysis for Western patients that we talked about yesterday. When we look at HARMONi-3 squamous in the first half of 2027, that's really a powered look at OS from an interim analysis perspective.
We're not going to give specific thresholds per se, because I think that it's a totality of what the curve looks like, number of events, maturity, so on and so forth. That Q1 or first half rather, 2027 look, that really would be that independent of PFS, that powered interim look at OS.
Thank you.
The next question is from the line of Brad Canino with Guggenheim. Your line is open. Please go ahead.
Hi. Thanks for the updates. Question from me is around the regional enrollment in H3. I'm wondering if that was done in parallel or if that was staggered, because I'm thinking about this from the perspective of making sure the subgroups at an early interim OS analysis aren't skewed by, say, the North American patients coming in later than the China patients and not having time to see the effect like actually happen in the HARMONi study. Thanks.
Thanks for the question, Brad. We've talked a little bit about the fact that the enrollment started together, generally speaking, but obviously enrollment in China is more rapid than it is in Western countries. There's certainly a little bit of data that you see that involves Chinese enrollment a little bit faster, which is typical of what you would see in many studies. I think when we look at the timing of the events, part of what we take away from the learnings from HARMONi and whatnot is to make sure we have sufficient events that have taken place across the globe. It's not sequential timing to the extent that HARMONi is by any stretch. Of course, it becomes important to have sufficient events across the study with respect to those events.
That's contemplated within our approach plan, and I'll let Alan add some comments as well.
Yeah, I'm going to add, Brad, to this. This is Allen. Brad, good question. Just commenting on some of the previous questions. I just want to remind everyone that HARMONi-3 was our global study, it was started globally at the same time. There are some differences. Certain regions open very quickly and enroll very quickly. Other areas, there's more administrative burden, like Europe, to get the ethics committee review to open. In the squamous study population, that is more prevalent in China, you'll see more aggressive enrollment. However, I think people are asking about the non-squamous cohorts, remember, we added that cohort after the study was ongoing. The sites were mostly open across the globe. In addition, that disease is more prevalent in the West.
It's probably two-thirds of non-small cell lung cancer outside of China, whereas in China it's the other way around with the squamous. Therefore, enrollment was actually very brisk in the West, we don't expect to see those differences.
All right. Thank you.
Sure.
Our next question is from the line of Mohit Bansal with Wells Fargo. Your line is open. Please go ahead.
Hi, this is Will Vang on for Mohit Bansal. Thanks for taking our question. Just kind of following up on HARMONi-3, I know you guys previously expanded the enrollment for the trial to include both squam and non-squam, but also the total size of the trial to push up some of these PFS and OS analysis timelines. Just want to understand, how are you guys thinking about, one, the risk of a higher proportion of these PFS and OS events coming from early progressors or early OS event patients? Two, just how you're thinking about what the medium follow-up time will look like at the first half interim OS for squam.
Yeah. The last question, I think, is probably the easier of the two in the sense of when we get to the first half of 2027, we would expect median follow-up time, generally speaking, in the low 20s months. Right? As I was saying before, consistent generally with what we saw in the HARMONi-6 OS analysis, as well as what we saw in terms of the Western follow-up for patients in the HARMONi study. With respect to the first question on not being dominated by early progressors, part of that also includes the larger sample size takes that effect away. With the smaller sample size, you run more variability.
You could be more dominated with unexpected answers, if you will, with respect to if you have a few more patients who progress early or pass away early, with a smaller sample size, you have a little bit more variability in what you see there. With a larger sample size, with what we see in squamous, unfortunately, those patients pass on a little bit earlier, so that doesn't require quite as large of a sample size. For the squamous and non-squamous, we have what we believe is a sufficient sample size in order to be able to avoid any of that statistical noise and variability that you can see.
I would just add, unlike the KEYNOTE-024, 042 studies, which were monotherapy IO, this includes chemotherapy, it should prevent early progression. The chemo will control the disease early in both cohorts, and allow the IO to take it back.
Your next question is from the line of David Dai with UBS. Your line is open. Please go ahead.
Great. Thanks for taking my questions. For the updated HARMONi data that you were presenting yesterday, could you help us understand the maturity of the updated OS data set relative to the September 2025 analysis and whether the incremental follow-up meaningfully increased the number of OS events observed? We just want to get a sense of whether the investor should really focus on the incremental improvements for HR from 0.78 to 0.76, or the fact the OS benefit remains stable despite a substantially longer Western follow-up.
Yeah. David, the main takeaway from the analysis yesterday, right, is that with meaningful follow-up in both regions, Asian and Western, you have a similar magnitude of benefit, right? I think as everybody is well aware, the HARMONi study was effectively enrolled first in China, a pause, and then enrolled in the West. That was based on the timing of when we did the transaction to in-license ivonescimab with our partners at Akeso, right? That's a little bit driven based on the circumstances of timing of the transaction and what was already enrolled at the time. When we look at the study as a whole, EGFR mutation-positive lung cancer is a disease that is more prevalent in Asian patients.
We would expect a higher proportion of patients to be enrolled in Asia, as is typical and has been run with the osimertinib studies, some of the amivantamab studies, so on and so forth. Because of that, it's about 60% Asian and about 40% Western. Again, typical split with respect to that for EGFR mutation positive. When we look at the global survival analysis overall, we saw pretty consistent results with the HARMONi-A study that was China only, and the HARMONi study, which was important because there was no clear detriment that was being seen from Western patients with very early follow-up time at the beginning. As that follow-up time matured, what we saw is the Western patients really kind of merged in and saw the same magnitude of benefit with the Asian patients.
We saw across the whole study, we saw a consistent magnitude of benefit irrespective of when we looked at the data. We saw the 0.79, 0.78 in the follow-up shortly thereafter the primary, and then the 0.76 that was announced yesterday. We're seeing that consistent magnitude of benefit. What we see is when the Western subgroup has additional maturity and those patients progress along the Kaplan-Meier curve, if you will, they have the same magnitude of benefit. I think our real takeaway is the importance of follow-up time, the importance of the maturity of the data, and that ultimately the consistency by which we saw the Western patients perform when they had meaningful time on study, and I think that was important.
Got it. Thanks. Just want to follow up. You stated yesterday that the updated HARMONi data was provided to the FDA. Can you just discuss whether the agency specifically requested this data and whether you have received any feedback regarding how the FDA views the more mature survival data so far?
Yeah. The data itself is a recently performed analysis. Even though the data cutoff is in June, it still takes a little bit of time to clean the data and finalize before performing. We've recently performed this analysis, and we have not received meaningful feedback in the short time since we made this data available to the FDA. Ultimately, we believe this data is important in the context of the full story regarding the HARMONi trial and the potential benefit of ivonescimab in the EGFR mutation-positive setting, and in particular including those patients in the U.S., given the specific health authority in which we're seeking approval in the U.S.
Got it. Thank you so much.
Your next question is from the line of Reni Benjamin with Citizens. Your line is open. Please go ahead.
Hey, thanks guys for taking the questions and congratulations on the progress. Maybe just starting off with the upcoming PDUFA date. Do you think this filing with the updated OS could result in a major amendment and a potential pushing back of the PDUFA date? Do you think likely this is going to progress as scheduled? Do you think that an ODAC panel could potentially be convened for this application? Just as a follow-up, if we take a step back and just look at the landscape, I'm kind of curious as to how you guys are thinking about the competitive positioning given the amivantamab data, some emerging Trop2 ADC data. Do you guys kind of feel that ivonescimab will be in this sandbox and kind of playing with everyone else? Is there certain competitive edges that could squeeze other players out? How are you thinking about it?
Thanks for the question, Reni. With respect to the PDUFA date, this is a new analysis, and again, we recently submitted this analysis to the agency. We don't have an expectation of the PDUFA date moving, but that's really a determination to be made by the agency, so we fully defer. That's ultimately their call should they decide that. The same holds true for any sort of advisory committee or ODAC as well. That's really exclusively an agency decision. With respect to where does ivonescimab fit in terms of competitive landscape and whatnot. As we look at these two agents right now that currently have some level of approval with the FDA.
There's a full approval for amivantamab in combination with chemotherapy, and then there's, as well as the datopotamab accelerated approval with respect to post-TKI and post-chemo, which is a little bit different than the indication that we're seeking, as well as the indication that amivantamab in combination with chemo has. Look, I think from an efficacy perspective, as Maky had mentioned, no compound at this point has shown a statistically significant overall survival benefit. If we look at the efficacy profile overall with respect to what we saw from the MARIPOSA-2 trial from the amivantamab plus chemotherapy, we see they're cross-trial comparisons, which is important, but generally consistent efficacy profile.
I think what we've shown with over 4,000 patients dosed across several different settings of clinical studies, we've shown a manageable safety profile that's consistent, generally speaking, irrespective of tumor type, irrespective of line of therapy, irrespective of histology. We've received a lot of KOL feedback with respect to the manageability and the tolerability of ivonescimab, and I think that's really important here. Obviously, datopotamab comes with a chemotherapy component, if you will, with a payload. All three regimens have a cytotoxic component. I think the other thing that's really important, there's also patients who will respond to different mechanisms. All three of these agents, the two that are approved, either accelerated or fully, and then the potential for the approval for ivonescimab would be three different components.
I think that provides physicians and patients with opportunities to mechanistically work differently from each other. A patient may respond to one and not the other. That choice is a good thing for physicians treating patients and for patients themselves, I think that's something that really differentiates this as opposed to maybe coming in with the same mechanism of action that we see in other spaces sometimes.
Great. Thanks for taking the questions.
Our next question is from Eric Schmidt from Cantor. Your line is open. Please go ahead.
Thank you for taking my question. Coming back to HARMONi-3, I think this is the first time we're hearing about two interim analyses. Want to confirm that that's always been the game plan, even if you haven't talked about it, that you're spending alpha on all three of these looks.
Eric, what I'd say is we've talked about OS analyses, plural, multiple times. I don't know if we've given the timing of the first half 2027 before. I think part of, as we look, we want to make sure we're transparent with respect to when the opportunities exist for results at different periods of time. Obviously we look at the OS analysis coming up. We look at follow-up time, what we've learned from HARMONi-6, and so on and so forth. With that follow-up time being important, we wanted to make sure that was highlighted for everyone.
There's alpha spent on all three days?
They're formal analyses. That's right.
One thing we didn't hear much about was your pre-commercial preparation in advance of the November 14th PDUFA date for HARMONi. Is that tracking as expected? Are you hiring field force or medical science liaisons? How's that going? Thank you.
Yeah, hey, Eric, this is Manmeet. As Maky mentioned in her prepared remarks, we are extensively preparing for our commercial launch with the anticipated PDUFA date of November 14th. We have already hired all the leadership team with extensive experience with both biotechs and pharma who have multiple launch experiences. We have market access team in place. We have marketing folks in place. Obviously, when you're talking about the field force, that generally comes a few weeks before the PDUFA date, but yes, we have all the planning and all the work under play.
I would just add on.
Thank you, Manmeet.
Yeah, I'd agree with everything Manmeet said, and then I also, you asked specifically about MSLs as well, which we have ramped up in support of each of the things that Manmeet highlighted.
Thank you, Dave. Yeah, I totally agree. Yeah. We've already ramped up the MSLs.
Thanks, guys.
Stifel. Your next question is from the line of Dara Azar from Stifel. Your line is open. Please go ahead.
Hi. Congrats on all the progress. I have a question on alpha spending and its potential impact on HARMONi-3 squamous OS. I'm curious, what gives you confidence that you can afford the alpha for another look at OS in the HARMONi-3 squamous next year as well? Would the alpha be passed to the next analysis if the first look is positive? A quick follow-up, is there any connection between tracking death events and the decision to add another look at the OS of squamous next year? Thanks so much.
Yeah. A couple of points there, Dara. I think on the last point, we've had this look in the first half of 2027. The timing, you don't necessarily always know the timing. It's event driven. The analysis has been there. The alpha spend with respect to the primary PFS look is pretty minimal, specifically because it's really intended to be supportive of the PFS analysis. In the events reached in the second half of this year is really intended to be the primary PFS look, and then there's a supportive look at OS. That alpha spend is minimal. There's not a lot of concern with respect to, if you will, quote unquote, "the amount spent" just based on maturity of OS at that time. It becomes pretty minimal. That gives an opportunity for two full looks, if you will, thereafter.
No real change in plan from that perspective. It's not like tracking death events, I think was the example that you gave. That's really been the plan throughout. As we look at the maturity timelines, the first half of 2027 is a key focal point with respect to reaching that median follow-up is a proxy that we've seen in both the HARMONi western patients where we showed that positive trending data yesterday and being more converged with the ITT in the Asian population, as well as the timing of the HARMONi-6 OS analysis as well.
Okay. Thank you.
Your next question is from the line of Faisal Khurshid with Jefferies. Your line is now open. Please go ahead.
Hey, guys. Thank you for taking the question. I wanted to actually go back to the HARMONi-3 interim PFS analysis that passed. Could you contextualize for us what was the alpha spend in that interim? Many investors have kind of interpreted missing that interim as suggesting that HARMONi-3 is tracking worse than HARMONi-6. Is that a correct take, and why or why not? Thank you.
Thanks, Faisal. I think I'd probably say a couple of things to effectively answer the questions that you're asking, which is the threshold to achieve statistical significance at the interim was meaningfully higher than that of what is needed for the final analysis. As well as we continue to see follow-up time is very important with ivonescimab. That is certainly, I think as we talked about last time, the timing of that analysis was shortly after as we looked at the completion of enrollment. We effectively announced completion of enrollment and then right into that interim analysis. Not a lot of follow-up time for many patients on that study. Those are two reasons why I don't think it's necessarily the right way to look at it with respect to different from HARMONi-6 one way or the other.
It's important also, that analysis was performed by the independent data monitoring committee. We remain fully blinded to that data. That's not something that we have hazard ratios and additional data for. We're confidently going into the second half of this year, and we've continued to learn more each time we have conducted analyses with respect to ivonescimab and continued to increase that confidence.
Great. Thank you.
Yeah, the only thing I'd add on top of that, Faisal, obviously, as you look at the Western subgroup that we published yesterday, with additional follow-up time, you see a pretty meaningful movement of the Western subgroups. Is a proxy here for follow-up time. Let's talk about Western patients and more of a proxy for follow-up time, but with that additional follow-up time, you do see movement there, which is important.
Understood. Thank you.
Your next question is from the line of Kristen Carter with Piper Sandler. Your line is now open. Please go ahead.
Hi, this is Kristen on for Kelsey. I believe you mentioned a little bit about what you've heard from KOLs. Could you expand on what they're saying post ASCO for HARMONi-6, please? Thank you.
Yeah. I think the KOLs for HARMONi-6 were very positive on the data. I think some of the feedback I've heard is that it's very encouraging. A 34% reduction in the risk of death is amazing over a PD-1. This is really phenomenal data. I think some of the feedback we got was that the discussant who wasn't very positive on the data sort of missed the point of the study, right? We understood fully, the ASCO committee understood fully that it was a regional study, right? Very exciting and intriguing data. There wasn't any discussion, the fact that we would have confirmatory or global data within the end of the year. We're less than six months away. The other thing is that there were other studies, three other studies supporting the observation that was seen there.
In addition, there was some discussion about age effect. In any of those other three studies, there was no difference by age group. In addition, the previous presentation of the HARMONi-6 data, which only had the PFS, there was an explanation of the age based on covariates. Finally, the most exciting thing about this agent is that it seems to be active in diseases that weren't traditionally active for PD-1s, like microsatellite stable colorectal cancer. None of these things were highlighted in this, but this was brought up a lot by a lot of the KOLs after the meeting.
Great. Thank you so much. Congratulations again.
We have reached the end of the question-and-answer session. I will now turn the call back to Dave for closing remarks. Please go ahead.
Thanks very much. I think I will hand it over directly to Bob.
Hi. Thanks, Dave. It's good to hear from our shareholders and our fellow stakeholders. Over the years, from nothing, I've raised over $1 billion of after-tax money in support of healthcare companies, whether they be drug or medical devices. It's been fun coming up with a vision and putting a team together for execution and watching the companies proceed. We know that ivonescimab works. The question I leave you with is, what if ivonescimab works really well? Have a good day.
Investor releaseQuarter not tagged2026-07-22Summit Therapeutics shares advance after updated Phase III cancer trial results (NASDAQ:SMMT)
InvestorsHub
Summit Therapeutics shares advance after updated Phase III cancer trial results (NASDAQ:SMMT)
Summit Therapeutics Inc. (NASDAQ:SMMT) shares gained 3% on Wednesday after the company released updated overall survival data from its global Phase III HARMONi trial evaluating ivonescimab in combination with chemotherapy for advanced lung cancer. The study enrolled patients with EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer whose disease had progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor. Updated results showed that patients treated in Western countries achieved an overall survival hazard ratio of 0.76, matching the outcome previously reported in the Asian patient population. The latest analysis, based on data collected through June 2026, included a median follow-up period of 23.2 months for Western patients, significantly longer than the 9.2 months available at the time of the primary analysis in April 2025. The hazard ratio of 0.76 was consistent across both the overall intention-to-treat population and the subgroup of Western participants. Asian patients in the trial had a median follow-up period of 32.7 months. The primary overall survival analysis, completed in April 2025, showed that ivonescimab combined with chemotherapy produced a favourable trend, with a hazard ratio of 0.79. However, the result narrowly missed statistical significance, recording a p-value of 0.057. Median overall survival reached 16.8 months for patients receiving ivonescimab plus chemotherapy, compared with 14.0 months for those treated with placebo alongside chemotherapy. Summit said the updated survival analysis has been submitted to the U.S. Food and Drug Administration as part of its ongoing review of the company’s Biologics License Application. The BLA currently has a PDUFA target action date of November 14, 2026. The company also noted that the HARMONi study had previously met one of its two primary endpoints by demonstrating a statistically significant improvement in progression-free survival. According to Summit, ivonescimab continued to exhibit an acceptable and manageable safety profile that remained consistent with earlier Phase III findings, with no new safety concerns identified in the latest data review. Summit Therapeutics stock price
Investor releaseQuarter not tagged2026-07-22Ivonescimab Plus Chemotherapy Shows Consistent, Favorable Overall Survival Results in Western and Asian Patients in Updated Analysis from Global Phase III HARMONi Study
Business Wire
Ivonescimab Plus Chemotherapy Shows Consistent, Favorable Overall Survival Results in Western and Asian Patients in Updated Analysis from Global Phase III HARMONi Study
Western Patients Achieved OS HR of 0.76, Consistent with Asian Patients in this Global Phase III Study MIAMI, July 22, 2026--(BUSINESS WIRE)--Summit Therapeutics Inc. (Nasdaq: SMMT) today announced results of an updated overall survival (OS) analysis from the global Phase III HARMONi clinical trial featuring the novel, potential first-in-class investigational bispecific antibody ivonescimab. Ivonescimab plus platinum-doublet chemotherapy in this trial continues to show a positive OS trend and a consistent efficacy and safety profile in Asian and western patients when compared to chemotherapy alone. The HARMONi study is evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with endothelial growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who were previously treated with a third-generation EGFR tyrosine kinase inhibitor (TKI). The study demonstrated a statistically significant benefit in the primary analysis for progression-free survival (PFS), one of the study’s two primary endpoints along with OS. Summit’s Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) is based on the results from the HARMONi trial and has a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026. In April 2025, the primary OS analysis was performed, whereby ivonescimab in combination with chemotherapy showed a positive trend without achieving a statistically significant benefit with a hazard ratio of 0.79 (95% CI: 0.62 – 1.01; p=0.057). Median OS was 16.8 months for those patients administered ivonescimab plus chemotherapy vs. 14.0 months for those receiving placebo plus chemotherapy. At the time of the primary analysis, median follow-up time for western patients was 9.2 months and less than the median OS at the time of the primary analysis. In September 2025, an additional analysis was performed, whereby the western patients were followed to increase their time on study (Asian patients were included and locked at the time of the primary analysis at a median follow-up time of 32.7 months). This analysis included longer-term follow-up of western patients of 13.7 months. A hazard ratio of 0.78 (95% CI: 0.62 – 0.98; nominal p=0.0332) was observed, consistent with the primary analysis. Median OS remained the same in both ar…Read full documentShow less
Western Patients Achieved OS HR of 0.76, Consistent with Asian Patients in this Global Phase III Study MIAMI, July 22, 2026--(BUSINESS WIRE)--Summit Therapeutics Inc. (Nasdaq: SMMT) today announced results of an updated overall survival (OS) analysis from the global Phase III HARMONi clinical trial featuring the novel, potential first-in-class investigational bispecific antibody ivonescimab. Ivonescimab plus platinum-doublet chemotherapy in this trial continues to show a positive OS trend and a consistent efficacy and safety profile in Asian and western patients when compared to chemotherapy alone. The HARMONi study is evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with endothelial growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who were previously treated with a third-generation EGFR tyrosine kinase inhibitor (TKI). The study demonstrated a statistically significant benefit in the primary analysis for progression-free survival (PFS), one of the study’s two primary endpoints along with OS. Summit’s Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) is based on the results from the HARMONi trial and has a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026. In April 2025, the primary OS analysis was performed, whereby ivonescimab in combination with chemotherapy showed a positive trend without achieving a statistically significant benefit with a hazard ratio of 0.79 (95% CI: 0.62 – 1.01; p=0.057). Median OS was 16.8 months for those patients administered ivonescimab plus chemotherapy vs. 14.0 months for those receiving placebo plus chemotherapy. At the time of the primary analysis, median follow-up time for western patients was 9.2 months and less than the median OS at the time of the primary analysis. In September 2025, an additional analysis was performed, whereby the western patients were followed to increase their time on study (Asian patients were included and locked at the time of the primary analysis at a median follow-up time of 32.7 months). This analysis included longer-term follow-up of western patients of 13.7 months. A hazard ratio of 0.78 (95% CI: 0.62 – 0.98; nominal p=0.0332) was observed, consistent with the primary analysis. Median OS remained the same in both arms from the primary analysis. An additional analysis was performed with a data cut-off date in June 2026, whereby most western patients have now discontinued treatment or completed two years of treatment. The median follow-up time for western patients now is 23.2 months. The cutoff date for Asian patients was consistent with the prior analysis with a median follow-up time of 32.7 months. A hazard ratio of 0.76 was observed in both the full intention-to-treat population and the subgroup of western patients. More detailed data from this analysis are intended to be presented at an upcoming medical meeting. These results have been made available to the FDA. The hazard ratios for the subgroup of western patients improved from the analysis in April 2025 to the September 2025 and June 2026 analyses with longer-term follow-up of western patients. With longer follow-up, results of western patients are now consistent in terms of the magnitude of OS benefit with those patients enrolled in Asia, who had a longer follow-up at the time of the primary OS analysis. In this most recent analysis, ivonescimab continued to demonstrate an acceptable and manageable safety profile that was consistent with previous Phase III data of ivonescimab plus chemotherapy. No additional safety signals were noted in this current HARMONi data cut. "The positive results from this latest overall survival analysis in the global HARMONi study continue to support the translation of the therapeutic profile of ivonescimab across the globe, including western patients from North America and Europe," stated Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit. "We have made this updated analysis available to the FDA as we continue to progress our BLA filing for the potential approval of ivonescimab in the U.S." "As we have consistently stated, the ivonescimab clinical trial data across multiple histologies and tumor types have repeatedly portrayed a consistent message: ivonescimab has the opportunity to make a significant difference in the lives of patients with cancer," added Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit. "Ivonescimab continues to demonstrate its potential to increase duration of life with a tolerable safety profile. With four positive Phase III studies and clear consistency between Asian and western patients demonstrated in the global HARMONi study in the gold-standard endpoint of overall survival, we believe that ivonescimab can represent the next generation of solid tumor cancer therapy through its differentiated bispecific design." About EGFR-Mutated NSCLC Lung cancer is the second most commonly diagnosed cancer worldwide and remains the leading cause of cancer-related death globally, with an estimated 2.6 million new cases and 1.9 million deaths in 2024.1 In the United States, the American Cancer Society estimates that approximately 230,000 new lung cancer cases will be diagnosed and nearly 125,000 deaths from lung cancer will occur in 2026.2 Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, representing approximately 80% to 85% of all cases.1,3 EGFR mutations are among the most common actionable oncogenic drivers in non-squamous NSCLC, occurring in approximately 10-15% of patients in western populations and 40-50% of patients in Asia.4,5 Activating EGFR mutations can drive tumor growth through aberrant EGFR signaling.6 EGFR tyrosine kinase inhibitors (TKIs), including third-generation EGFR TKIs, are an important treatment approach for patients with advanced EGFR-mutated NSCLC.4 Despite advances with EGFR-targeted therapy, most patients with locally advanced or metastatic EGFR-mutated NSCLC eventually experience disease progression after treatment with a third-generation EGFR TKI.7 In patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC previously treated with a third-generation EGFR TKI, treatment options remain limited, underscoring the need for new therapeutic approaches after progression on EGFR-targeted therapy.7 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 colorectal cancer (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 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 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. References 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/20260722390898/en/ Contacts Summit Therapeutics’ Media & Investor Contacts:Nathan LiaBraatenSenior Director, Investor Relations Tracy JonesDirector, Media & Public Relations [email protected] [email protected]
Investor releaseQuarter not tagged2026-07-22SMMT Stock Gains After Summit Reports Strong Lung Cancer Survival Results — Investors Await Q2 Earnings
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SMMT Stock Gains After Summit Reports Strong Lung Cancer Survival Results — Investors Await Q2 Earnings
Summit is seeking an FDA decision on its ivonescimab application by November. The company is also studying the drug in other types of Non-Small Cell Lung Cancer and metastatic colorectal cancer. Earlier this month, the company sold its only other late-stage antibiotic program, ridinilazole, to Biossil Inc. Shares of Summit Therapeutics (SMMT) jumped as much as 5% on Wednesday before paring some gains after the company released updated and positive survival results from a major late-stage study of its lead drug, ivonescimab. The new analysis from the global late-stage trial showed that ivonescimab, when added to chemotherapy, delivered consistent survival benefits for patients with advanced non-small cell lung cancer who carry an EGFR mutation and had previously been treated with a targeted therapy. The improvement was seen in both Western patients and Asian patients, addressing an important question about how well the drug works across different populations, the company said. See what 10M+ investors are talking about. Get the Stocktwits Daily Rip for what retail is watching right now, free to your inbox The company said it has already shared the latest data with the U.S. Food and Drug Administration. Summit is seeking approval for ivonescimab in this lung cancer setting, with a regulatory decision expected by November 14. Ivonescimab is an investigational cancer treatment that combines two approaches in a single drug: it helps the immune system attack cancer cells while also blocking the growth of blood vessels that tumors need to survive. Summit is also studying the drug in other types of Non-Small Cell Lung Cancer, and even metastatic colorectal cancer Earlier this month, the company sold its only other late-stage antibiotic program, ridinilazole, to Biossil Inc, to concentrate resources on ivonescimab. Summit is scheduled to report second-quarter results after market close on Thursday. On Stocktwits, retail sentiment around SMMT stock jumped from ‘bullish’ to ‘extremely bullish’ over the past 24 hours, while message volume increased from ‘normal’ to ‘high’ levels. A Stocktwits user said that investors are waiting for the earnings report on Thursday before committing to new buys, and hence the stock isn't rallying further. According to data from Fiscal AI, analysts on average expect Summit to report a second-quarter loss per share of about $0.28, compared…Read full documentShow less
Summit is seeking an FDA decision on its ivonescimab application by November. The company is also studying the drug in other types of Non-Small Cell Lung Cancer and metastatic colorectal cancer. Earlier this month, the company sold its only other late-stage antibiotic program, ridinilazole, to Biossil Inc. Shares of Summit Therapeutics (SMMT) jumped as much as 5% on Wednesday before paring some gains after the company released updated and positive survival results from a major late-stage study of its lead drug, ivonescimab. The new analysis from the global late-stage trial showed that ivonescimab, when added to chemotherapy, delivered consistent survival benefits for patients with advanced non-small cell lung cancer who carry an EGFR mutation and had previously been treated with a targeted therapy. The improvement was seen in both Western patients and Asian patients, addressing an important question about how well the drug works across different populations, the company said. See what 10M+ investors are talking about. Get the Stocktwits Daily Rip for what retail is watching right now, free to your inbox The company said it has already shared the latest data with the U.S. Food and Drug Administration. Summit is seeking approval for ivonescimab in this lung cancer setting, with a regulatory decision expected by November 14. Ivonescimab is an investigational cancer treatment that combines two approaches in a single drug: it helps the immune system attack cancer cells while also blocking the growth of blood vessels that tumors need to survive. Summit is also studying the drug in other types of Non-Small Cell Lung Cancer, and even metastatic colorectal cancer Earlier this month, the company sold its only other late-stage antibiotic program, ridinilazole, to Biossil Inc, to concentrate resources on ivonescimab. Summit is scheduled to report second-quarter results after market close on Thursday. On Stocktwits, retail sentiment around SMMT stock jumped from ‘bullish’ to ‘extremely bullish’ over the past 24 hours, while message volume increased from ‘normal’ to ‘high’ levels. A Stocktwits user said that investors are waiting for the earnings report on Thursday before committing to new buys, and hence the stock isn't rallying further. According to data from Fiscal AI, analysts on average expect Summit to report a second-quarter loss per share of about $0.28, compared to the loss of $0.76 reported in the corresponding period of 2025. SMMT stock has dropped 15% year-to-date. Read More: RKLB Stock On Track For Second Straight Day Of Gains — Stifel Hails HASTE’s $266M Award As Major Validation For updates and corrections, email newsroom[at]stocktwits[dot]com. Anan Ashraf has no position in any of the stocks mentioned in this article. StockTwits' news team content is for informational purposes only and is not intended as investment advice. For more, see our editorial policy. This article was originally published on StockTwits. Related: Nasdaq, S&P 500, Dow Futures Edge Higher, Brushing Off Fresh US-Iran Clashes As Earnings Take Center Stage: TSLA, NOW, GOOGL, NOK In Focus ASTS Stock Eyes Weekly Comeback: AT&T Says AST SpaceMobile Satellite Offering Will 'Come To Fruition' Next Year SPCX Gains After Hours Ahead Of Upcoming Starship Test Flight— Tesla Books $1B SpaceX Gain

