Granola Launches AI Workspace for Teams and Raises $43M Series B
LONDON--(BUSINESS WIRE)--Granola, the AI-powered notepad that combines your typed notes with AI transcriptions, today launches Granola 2.0. This major update transforms the company's popular AI meeting assistant into a powerful, intelligent workspace for teams. Every day, Granola transcribes and analyzes millions of minutes of conversation: collective knowledge which is now accessible and actionable across entire organizations.
"Since our launch a year ago, people have started referring to Granola as their 'second brain,'" said Christopher Pedregal, Co-Founder of Granola. "With Granola 2.0, we're bringing that power to your entire team, tapping into the most up-to-date, relevant data on what's happening in your company – the conversations your employees are having day in, day out."
Granola 2.0 and all its features are rolling out today. New users can download the desktop app and create their first shared folder in under a minute.
Beyond Meeting Notes: Harnessing Shared Context with AI
Granola has identified that the most valuable information in companies isn't found in static documents or wikis, but in the daily conversations happening across teams.
"Harnessing shared meeting context with AI will be a core tool of how effective teams work in the future," said Pedregal. "Our vision is to make Granola the place your team gets work done – a powerful, intelligent workspace sitting on top of living, up-to-date context of what's happening in your company."
With the launch of 2.0, Granola is now a collaborative workspace that transforms how teams capture, share, and leverage collective knowledge:
Shared Team Folders: Create dedicated spaces for Sales Calls, Customer Feedback, Hiring Loops, Weekly Syncs, and more, with folders that anyone on your team can access (even without a Granola account)
Chat with Folders: Query across an entire folder of meeting notes using best-in-class reasoning models, with AI delivering insights that cite specific meetings and transcripts as sources
Enterprise Collaboration: Business & Enterprise users can explore any public folder inside their domain—perfect for competitive intel, customer success, or onboarding new hires
Slack Integration: with a one-time connection to Slack, Granola can keep your whole team in the with concise summaries and a 'chat with this meeting' button posted to your chosen channel the moment the call ends
"With every call in one place, sales leaders can ask 'Why are we losing deals this quarter?,' product managers can investigate 'Which UX issues come up most often?,' and recruiters can understand 'Where do our interviews keep stalling?' — all answered instantly with source-linked citations," said Sam Stephenson, Co-Founder of Granola.
What's Next
The launch also coincides with the announcement that Granola has raised $43 million in Series B funding led by Nat Friedman and Daniel Gross from NFDG, with continued participation from existing investors Mike Mignano from Lightspeed Venture Partners and Nabeel Hyatt from Spark Capital. The company has also attracted investment from an impressive roster of angel investors, including Guillermo Rauch (Vercel), Amjad Masad (Replit), Tobi Lutke (Shopify), Karri Saarinen (Linear), Lenny Rachitsky (Lenny's Newsletter), Des Traynor (Intercom), Karim Atiyeh (Ramp), Zach Lloyd (Warp), Charlie Songhurst, Noah Weiss, Romain Huet, Nilan Peiris and Laura Modiano.
With this funding, Granola plans to continue expanding its team in London to accelerate product development. The company is focused on making Granola a tool that not only helps teams work better but think better.
About Granola
Granola was founded in March 2023 by Chris Pedregal and Sam Stephenson to change the way we work, with tools that understand us, anticipate our actions, and augment our abilities. In May 2023 they raised a $4.25M Seed round from Lightspeed Venture Partners, betaworks and FirstMinute, and raised a further $20M Series A in October 2024, led by Spark Capital, with participation from investors AI Grant, Lightspeed, Betaworks, Firstminute Capital, and others.
About the Founders
Chris Pedregal - https://www.linkedin.com/in/pedregal/
Chris studied Computer Science at Stanford before joining Google as a Product Manager, where he worked on Gmail, Search and Maps. In 2013 he quit to launch Socratic, an AI-powered tutor for high school students, which grew organically to 10+ million MAUs and won 'App of the Year' in 2017. In 2018, Socratic was acquired by Google, where it receives over four billion questions a year.
Sam Stephenson -
Sam studied graphic design at Falmouth before spending a few years in San Francisco at a design agency and an education non-profit. Along the way, he built his own startup connecting neighborhoods to local farmers, helped build an iOS app for Swim Smooth, designed interactive ski maps for Carv and helped an array of B2B companies with design and front end development.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
an hour ago
- Yahoo
Ivonescimab Plus Chemotherapy Demonstrates Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in Patients with EGFR-Mutant Non-Small Cell Lung Cancer after EGFR TKI Therapy in Global Study
Consistent Results Noted between Single Region HARMONi-A and Multiregional HARMONi Studies; Favorable Trends in Sub-Populations from North America and China for Both Primary Endpoints Were Observed Ivonescimab in Combination with Chemotherapy Reduces the Risk of Disease Progression or Death by 48% Compared to Chemotherapy Alone; Positive Overall Survival Trend Observed with Hazard Ratio of 0.79 HARMONi Represents the First Phase III Trial to Evaluate Ivonescimab in a Multiregional Setting Summit to Determine Timing of US BLA Filing MIAMI, May 30, 2025--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today announced topline results from the Phase III clinical trial, HARMONi, the first global Phase III study evaluating ivonescimab, successfully met the progression-free survival (PFS) primary endpoint and showed a positive trend in the other primary endpoint, overall survival (OS). HARMONi is a multiregional, double-blinded, placebo-controlled, Phase III study sponsored by Summit evaluating ivonescimab plus platinum-doublet chemotherapy 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) who have progressed after treatment with a 3rd generation EGFR tyrosine kinase inhibitor (TKI). This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials in showing either a PFS or OS benefit. Approximately 38% of patients were randomized from western countries (ex-Asia), consistent with other recent multiregional Phase III studies in patients with EGFR-mutated NSCLC. At the prespecified primary data analysis, ivonescimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, with a hazard ratio of 0.52 (95% CI: 0.41 – 0.66; p<0.00001). PFS was measured by blinded independent central radiology review committee (BICR) compared to placebo in combination with chemotherapy. A clinically meaningful hazard ratio was observed in both Asia and ex-Asia sub-populations. The primary analysis demonstrated the consistency of the magnitude of the PFS benefit between patients randomized in Asia and ex-Asia, as well as the consistency in a single-region study (HARMONi-A) with this multiregional study. Ivonescimab in combination with chemotherapy showed a positive trend in OS in the primary analysis without achieving a statistically significant benefit with a hazard ratio of 0.79 (95% CI: 0.62 – 1.01; p=0.057). This trend provides further support for its use in 2L+ EGFRm NSCLC, a setting where high unmet need continues to exist with limited approved options in the United States and other western territories. There are no current FDA-approved regimens that have demonstrated a statistically significant overall survival benefit in this patient setting. The median follow-up time for western patients was less than the median overall survival at the time of the analysis, and these patients may continue to be followed for long-term outcomes. Both Asian and North American patients demonstrated a positive trend in overall survival. The results of the primary analysis in this multiregional study were consistent with that of the single-region HARMONi-A study, which demonstrated an overall survival hazard ratio of 0.80 at 52% data maturity in a similar patient population. There were no new safety signals noted in this Phase III study. Grade 3 or higher treatment-emergent adverse events (TEAEs) were reported for 56.9% of patients in the ivonescimab + chemotherapy arm vs 50.0% with chemotherapy alone. Fatal TEAEs (excluding disease progression) were reported for 1.8% of patients in the ivonescimab + chemotherapy arm vs. 2.8% in those patients receiving chemotherapy alone. The safety profile of ivonescimab + chemotherapy was acceptable and manageable in the context of the observed clinical benefit. "The evidence of a consistent benefit in PFS for both Asian and western patients, as well as the consistent overall survival results between the single-region HARMONi-A study and our global HARMONi study demonstrates the potential benefit ivonescimab has to bring to patients around the world, including the United States," stated Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit Therapeutics. Based on the results of the HARMONi clinical trial, Summit, at present time, intends to file a Biologics License Application (BLA) in order to seek approval for ivonescimab plus chemotherapy in this setting. Based on discussions with the United States Food & Drug Administration (FDA), under our determination and subject to our review, Summit will consider the timing of the filing of this BLA. The FDA noted that a statistically significant overall survival benefit is necessary to support marketing authorization, which will weigh into Summit's considerations regarding the timing of a potential BLA filing. A more complete data presentation from the clinical study is intended to be shared at a future major medical conference. "Our conviction in the promise that this therapy holds for patients continues to be validated: we believe that ivonescimab has the potential to make a meaningful difference for the betterment of patients' lives," added Dr. Maky Zanganeh, President and Co-CEO of Summit. The positive Phase III HARMONi study results, along with the approval of ivonescimab in China in combination with chemotherapy based on the results of the HARMONi-A trial and the subsequent supplemental approval of ivonescimab monotherapy in China for first-line treatment of patients with advanced NSCLC whose tumors have positive PD-L1 expression based on the results of the HARMONi-2 trial, further substantiates the purposefully-engineered, differentiated mechanism of action of ivonescimab, a PD-1 / VEGF bispecific antibody evidencing cooperative binding characteristics, and its opportunity to improve upon the existing standards of care for solid tumors, including in settings where existing immune checkpoint inhibitors are indicated. We would like to offer our heartfelt gratitude to each of the patients, physicians, nurses, and caregivers who participated in and supported this clinical study. We are grateful to the dedication of our investigators and patients who are essential in advancing innovative therapies and bringing to patients the most advanced therapies for those facing unfortunate diagnoses. 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 in China and Australia, 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. 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 could 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. Ivonescimab's tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, SITC, 2023). 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, SITC, 2023), is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets. Ivonescimab was engineered by Akeso Inc. (HKEX Code: and is currently engaged in multiple Phase III clinical trials. Over 2,300 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3, and the Company has begun to enroll patients in the United States for HARMONi-7. HARMONi is a Phase III clinical trial which is evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). Top-line results were announced in May 2025, which included a statistically significant and clinically meaningful benefit in progression-free survival and a positive trend in overall survival, the trial's two primary endpoints. Consistent results were noted between the single region HARMONi-A study and the multiregional HARMONi study. HARMONi-3 is a Phase III clinical trial which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous and non-squamous NSCLC. HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials for ivonescimab in NSCLC: HARMONi-A, HARMONi-2, and HARMONi-6. 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. Approximately 85% of patients received a 3rd generation EGFR-TKI prior to randomization in the study. 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. 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, and its label was expanded in China in April 2025. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration ("FDA") for the HARMONi clinical trial setting. About Summit Therapeutics Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol "SMMT"). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK. For more information, please visit and follow us on X @SMMT_TX. Summit Forward-looking Statements Any statements in this press release about the Company's future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company's product candidates, entry into and actions related to the Company's partnership with Akeso Inc., the 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, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program ("ATM Program"), the expected proceeds and uses thereof, 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, 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" section of filings that the Company makes with the Securities and Exchange Commission. 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 2025, Summit Therapeutics Inc. All Rights Reserved View source version on Contacts Contact Summit Investor Relations: Dave GancarzChief Business & Strategy OfficerNathan LiaBraatenSenior Director, Investor Relationsinvestors@ media@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
an hour ago
- Business Wire
DV INVESTOR ALERT: Robbins Geller Rudman & Dowd LLP Announces that DoubleVerify Holdings, Inc. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit
SAN DIEGO--(BUSINESS WIRE)-- Robbins Geller Rudman & Dowd LLP DoubleVerify class action lawsuit. Captioned Electrical Workers Pension Fund, Local 103, I.B.E.W. v. DoubleVerify Holdings, Inc., No. 25-cv-04332 (S.D.N.Y.), the DoubleVerify class action lawsuit charges DoubleVerify and certain of DoubleVerify's top executives with violations of the Securities Exchange Act of 1934. If you suffered substantial losses and wish to serve as lead plaintiff of the DoubleVerify class action lawsuit, please provide your information here: CASE ALLEGATIONS: DoubleVerify provides media effectiveness platforms. The DoubleVerify class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (i) DoubleVerify's customers were shifting their ad spending from open exchanges to closed platforms, where DoubleVerify's technological capabilities were limited and competed directly with native tools provided by platforms like Meta Platforms and Amazon; (ii) DoubleVerify's ability to monetize on its Activation Services was limited because the development of its technology for closed platforms was significantly more expensive and time-consuming than disclosed to investors; (iii) DoubleVerify's Activation Services in connection with certain closed platforms would take several years to monetize; (iv) DoubleVerify's competitors were better positioned to incorporate AI into their offerings on closed platforms, which impaired DoubleVerify's ability to compete effectively and adversely impacted DoubleVerify's profits; (v) DoubleVerify systematically overbilled its customers for ad impressions served to declared bots operating out of known data center server farms; and (vi) DoubleVerify's risk disclosures were materially false and misleading because they characterized adverse facts that had already materialized as mere possibilities. The DoubleVerify class action lawsuit further alleges that on February 28, 2024, DoubleVerify issued lower revenue growth expectations for the first quarter of 2024 due to 'a slow start by brand advertisers and a slow ramp by recently signed' customers. On this news, the price of DoubleVerify stock fell more than 21%, according to the complaint. Then, on May 7, 2024, as the DoubleVerify class action lawsuit alleges, DoubleVerify cut its full-year 2024 revenue outlook due to customers that were pulling back on their ad spending. On this news, the price of DoubleVerify stock fell nearly 39%, according to the complaint. The DoubleVerify class action lawsuit further alleges that on February 27, 2025, DoubleVerify reported lower-than-expected fourth quarter 2024 sales and earnings due in part to reduced customer spending, and defendants further disclosed that the shift of ad dollars from open exchanges to closed platforms was negatively impacting DoubleVerify. On this news, the price of DoubleVerify stock fell more than 36%, according to the complaint. THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired DoubleVerify common stock during the Class Period to seek appointment as lead plaintiff in the DoubleVerify class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the DoubleVerify class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the DoubleVerify class action lawsuit. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the DoubleVerify class action lawsuit. ABOUT ROBBINS GELLER: Robbins Geller Rudman & Dowd LLP is one of the world's leading law firms representing investors in securities fraud and shareholder litigation. Our Firm has been ranked #1 in the ISS Securities Class Action Services rankings for four out of the last five years for securing the most monetary relief for investors. In 2024, we recovered over $2.5 billion for investors in securities-related class action cases – more than the next five law firms combined, according to ISS. With 200 lawyers in 10 offices, Robbins Geller is one of the largest plaintiffs' firms in the world, and the Firm's attorneys have obtained many of the largest securities class action recoveries in history, including the largest ever – $7.2 billion – in In re Enron Corp. Sec. Litig. Please visit the following page for more information: Past results do not guarantee future outcomes. Services may be performed by attorneys in any of our offices.
Business Wire
an hour ago
- Business Wire
Ivonescimab Plus Chemotherapy Demonstrates Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in Patients with EGFR-Mutant Non-Small Cell Lung Cancer after EGFR TKI Therapy in Global Study
MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) ('Summit,' 'we,' or the 'Company') today announced topline results from the Phase III clinical trial, HARMONi, the first global Phase III study evaluating ivonescimab, successfully met the progression-free survival (PFS) primary endpoint and showed a positive trend in the other primary endpoint, overall survival (OS). HARMONi is a multiregional, double-blinded, placebo-controlled, Phase III study sponsored by Summit evaluating ivonescimab plus platinum-doublet chemotherapy 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) who have progressed after treatment with a 3 rd generation EGFR tyrosine kinase inhibitor (TKI). This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials in showing either a PFS or OS benefit. Approximately 38% of patients were randomized from western countries (ex-Asia), consistent with other recent multiregional Phase III studies in patients with EGFR-mutated NSCLC. At the prespecified primary data analysis, ivonescimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, with a hazard ratio of 0.52 (95% CI: 0.41 – 0.66; p<0.00001). PFS was measured by blinded independent central radiology review committee (BICR) compared to placebo in combination with chemotherapy. A clinically meaningful hazard ratio was observed in both Asia and ex-Asia sub-populations. The primary analysis demonstrated the consistency of the magnitude of the PFS benefit between patients randomized in Asia and ex-Asia, as well as the consistency in a single-region study (HARMONi-A) with this multiregional study. Ivonescimab in combination with chemotherapy showed a positive trend in OS in the primary analysis without achieving a statistically significant benefit with a hazard ratio of 0.79 (95% CI: 0.62 – 1.01; p=0.057). This trend provides further support for its use in 2L+ EGFRm NSCLC, a setting where high unmet need continues to exist with limited approved options in the United States and other western territories. There are no current FDA-approved regimens that have demonstrated a statistically significant overall survival benefit in this patient setting. The median follow-up time for western patients was less than the median overall survival at the time of the analysis, and these patients may continue to be followed for long-term outcomes. Both Asian and North American patients demonstrated a positive trend in overall survival. The results of the primary analysis in this multiregional study were consistent with that of the single-region HARMONi-A study, which demonstrated an overall survival hazard ratio of 0.80 at 52% data maturity in a similar patient population. There were no new safety signals noted in this Phase III study. Grade 3 or higher treatment-emergent adverse events (TEAEs) were reported for 56.9% of patients in the ivonescimab + chemotherapy arm vs 50.0% with chemotherapy alone. Fatal TEAEs (excluding disease progression) were reported for 1.8% of patients in the ivonescimab + chemotherapy arm vs. 2.8% in those patients receiving chemotherapy alone. The safety profile of ivonescimab + chemotherapy was acceptable and manageable in the context of the observed clinical benefit. 'The evidence of a consistent benefit in PFS for both Asian and western patients, as well as the consistent overall survival results between the single-region HARMONi-A study and our global HARMONi study demonstrates the potential benefit ivonescimab has to bring to patients around the world, including the United States,' stated Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit Therapeutics. Based on the results of the HARMONi clinical trial, Summit, at present time, intends to file a Biologics License Application (BLA) in order to seek approval for ivonescimab plus chemotherapy in this setting. Based on discussions with the United States Food & Drug Administration (FDA), under our determination and subject to our review, Summit will consider the timing of the filing of this BLA. The FDA noted that a statistically significant overall survival benefit is necessary to support marketing authorization, which will weigh into Summit's considerations regarding the timing of a potential BLA filing. A more complete data presentation from the clinical study is intended to be shared at a future major medical conference. 'Our conviction in the promise that this therapy holds for patients continues to be validated: we believe that ivonescimab has the potential to make a meaningful difference for the betterment of patients' lives,' added Dr. Maky Zanganeh, President and Co-CEO of Summit. The positive Phase III HARMONi study results, along with the approval of ivonescimab in China in combination with chemotherapy based on the results of the HARMONi-A trial and the subsequent supplemental approval of ivonescimab monotherapy in China for first-line treatment of patients with advanced NSCLC whose tumors have positive PD-L1 expression based on the results of the HARMONi-2 trial, further substantiates the purposefully-engineered, differentiated mechanism of action of ivonescimab, a PD-1 / VEGF bispecific antibody evidencing cooperative binding characteristics, and its opportunity to improve upon the existing standards of care for solid tumors, including in settings where existing immune checkpoint inhibitors are indicated. We would like to offer our heartfelt gratitude to each of the patients, physicians, nurses, and caregivers who participated in and supported this clinical study. We are grateful to the dedication of our investigators and patients who are essential in advancing innovative therapies and bringing to patients the most advanced therapies for those facing unfortunate diagnoses. 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 in China and Australia, 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. 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 could 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. Ivonescimab's tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, SITC, 2023). 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, SITC, 2023), is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets. Ivonescimab was engineered by Akeso Inc. (HKEX Code: and is currently engaged in multiple Phase III clinical trials. Over 2,300 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3, and the Company has begun to enroll patients in the United States for HARMONi-7. HARMONi is a Phase III clinical trial which is evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). Top-line results were announced in May 2025, which included a statistically significant and clinically meaningful benefit in progression-free survival and a positive trend in overall survival, the trial's two primary endpoints. Consistent results were noted between the single region HARMONi-A study and the multiregional HARMONi study. HARMONi-3 is a Phase III clinical trial which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous and non-squamous NSCLC. HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials for ivonescimab in NSCLC: HARMONi-A, HARMONi-2, and HARMONi-6. 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. Approximately 85% of patients received a 3 rd generation EGFR-TKI prior to randomization in the study. 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. 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, and its label was expanded in China in April 2025. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration ('FDA') for the HARMONi clinical trial setting. About Summit Therapeutics Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol "SMMT"). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK. For more information, please visit and follow us on X @SMMT_TX. Summit Forward-looking Statements Any statements in this press release about the Company's future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company's product candidates, entry into and actions related to the Company's partnership with Akeso Inc., the 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, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program ('ATM Program'), the expected proceeds and uses thereof, 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, 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" section of filings that the Company makes with the Securities and Exchange Commission. 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. Copyright 2025, Summit Therapeutics Inc. All Rights Reserved
