Summit Therapeutics will host a third quarter 2024 financial results and operational progress conference call on October 30, 2024

HARMONi is a Phase III clinical trial designed to evaluate ivonescimab in combination with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have been treated with one 3 progression has occurred^approx Generation EGFR-TKI (e.g. osimertinib).

HARMONi-3 is a Phase III clinical trial designed to evaluate ivonescimab in combination with chemotherapy compared to pembrolizumab in combination with chemotherapy in patients with first-line metastatic squamous cell NSCLC.

HARMONi-7 is a planned Phase III clinical trial designed to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 TPS). > 50%).

In addition, Akeso recently achieved positive results in two randomized Phase III clinical trials for ivonescimab in NSCLC, HARMONi-A and HARMONi-2, in a single region (China).

HARMONi-A was a phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutant, locally advanced or metastatic non-squamous NSCLC who were treated with NSCLC progression occurred after an EGFR-TKI.

HARMONi-2 is a Phase III clinical trial evaluating ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression (PD-L1 TPS). >1%).

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s licensed territories, including the United States and Europe. Ivonescimab was approved for marketing approval in China in May 2024. Ivonescimab received Fast Track designation from the U.S. Food & Drug Administration (FDA) for the HARMONi clinical trial.

About Summit Therapeutics

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development and commercialization of patient-, physician-, caregiver- and society-friendly medical therapies aimed at improving quality of life, extending potential life expectancy and addressing serious unsolved problems to solve medical needs.

Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol “SMMT”). Our headquarters are in Miami, Florida, and we have additional offices in Menlo Park, California and Oxford, United Kingdom.

For more information, please visit and follow us on X @SMMT_TX.

Forward-looking statements from the summit

Any statements in this press release regarding the Company’s future expectations, plans and prospects, including, but not limited to, statements regarding the clinical and preclinical development of the Company’s product candidates, entry into, and actions taken in connection with the Company’s partnership with Akeso Inc ., the intended use of the net proceeds from the private placements, the Company’s expected expenses and cash reserves, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of commencement, completion and the availability of clinical trial data , the possible filing of applications for marketing authorizations, potential acquisitions, statements regarding the previously announced at-the-market stock offering program (“ATM Program”), the expected proceeds and uses thereof, and other statements containing the words “expect”, “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “aim “. “,” “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 in 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, conditions affecting the capital markets, general economic, industry or political conditions, including the results of our evaluation of the underlying data in connection with the developments – and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties associated with the initiation of future clinical trials, the availability and timing of data from current and future clinical trials, the results of such trials and their success, and global public health crises, which may impact the timing and status of our clinical trials and operations, whether preliminary results of a clinical trial are predictive of the final results of that trial or results earlier clinical trials or preclinical studies will be indicative of the results of subsequent clinical trials, whether business development opportunities exist to expand the Company’s drug candidate pipeline, including through potential acquisitions and/or collaborations with other companies, expectations regarding regulatory approvals, laws and regulations relating to government contracts and financing awards, the availability of sufficient financing to meet the Company’s foreseeable and unpredictable operating expenses and capital expenditure requirements, and other factors discussed in the “Risk Factors” section of the Company’s filings with the Securities and Exchange Commission. Any change in our ongoing studies could result in delays, impact our future expenses and add uncertainty to our commercialization efforts and impact the likelihood of successful completion of the clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements contained in this press release reflect only the Company’s views as of the date of this press release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company expressly disclaims any obligation to update the forward-looking statements contained in this press release.

View source version on businesswire.com:

Contacts

Contact Summit Investor Relations:
Dave Gancarz
Chief Business & Strategy Officer

Nathan Lia Braaten
Senior Director, Investor Relations

investors@smmttx.com