Summit Therapeutics to Present at March Investor Conferences Following FDA Filing Acceptance

Summit Therapeutics Inc. (NASDAQ: SMMT) announced that it will participate in three upcoming investor conferences during March of this year. Members of the Summit leadership team will participate in individual investor meetings along with some fireside chats at TD Cowen's 46th Annual Health Care Conference in Boston on Monday, March 2, 2026, Jefferies Conference in Miami on Tuesday, March 10, 2026, and Citizens Life Sciences Conference in Miami on Wednesday, March 11, 2026.

The fireside chats will be available live on the company's website at www.smmttx.com. An archived version of both presentations will be available on the website following the presentation. The TD Cowen fireside chat is scheduled for 2:30pm ET, while the Citizens Life Sciences fireside chat is scheduled for 2:15pm ET. The Jefferies Conference will include investor meetings only.

The presentations follow the U.S. FDA's acceptance of the company's Biologics License Application (BLA) for ivonescimab in combination with chemotherapy in patients who have progressed after targeted therapy. The FDA accepted the application for filing in January 2026, with the goal Prescription Drug User Fee Act (PDUFA) date set for November 14, 2026.

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.

Ivonescimab's specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the tumor microenvironment (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 molecule has 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.

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

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

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization. The application aims to fill a market gap by catering to 14,000 eligible U.S. patients annually, along with the existing commercial exposure in China through the company's partnership with Akeso.

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

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

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

As of the close of play on February 12, consensus sentiment around Summit Therapeutics was moderately bullish. The stock had received coverage from 6 analysts, 4 of whom had assigned Buy ratings and 2 gave Hold calls. With no Sell rating, the stock carries a projected median 1-year price target of $57.98, implying a strong upside of more than 296%.