OSE Immunotherapeutics to Present Groundbreaking Extension Period Data on Lusvertikimab at DDW 2025
New Clinical Data from Phase 2 Extension Period in Ulcerative Colitis on Long-Term Benefits and Safety of Anti-IL-7R mAb Lusvertikimab

NANTES, France – April 9, 2025, 7:30 a.m. CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a biotech company dedicated to developing first-in-class therapies in immuno-oncology and immuno-inflammation, today announced that the Company will present further efficacy and safety data¹ from the 24-week Open Label Extension (OLE) period from CoTikiS Phase 2 clinical study of Lusvertikimab in ulcerative colitis at the Digestive Disease Week conference in San Diego (May 3 – 6, 2025).

Following the excellent efficacy and safety profile from the trial’s induction period presented as a highlight at the 2025 ECCO congress, this oral presentation will unveil new clinical data from the 24-week Open Label Extension (OLE) period (Week 10 to Week 34) of the randomized, double-blind, placebo-controlled Phase 2 study evaluating the anti-IL-7 receptor monoclonal antibody Lusvertikimab in moderate to severe ulcerative colitis. These new findings are expected to provide deeper insights into the long-term benefits and safety of Lusvertikimab, supporting further development in ulcerative colitis, as well as in other chronic autoimmune and inflammatory diseases.

Presentation details:

Title: “LUSVERTIKIMAB, A FIRST IN CLASS IL7 RECEPTOR ANTAGONIST, IN MODERATE TO SEVERE ULCERATIVE COLITIS: RESULTS OF A MULTICCENTER RANDOMIZED PLACEBO-CONTROLLED PHASE II STUDY”

Date and Time: Monday, May 05, 2025, from 4:45pm to 5:00pm Pacific Time
Session Presentation: Clinical Trials in IBD: Biologics and Emerging Therapies
Session Number: 0004

ABOUT ULCERATIVE COLITIS (UC)
Ulcerative colitis is a chronic disease of the large intestine, or colon, and rectum, in which the lining of the gastrointestinal tract becomes inflamed and develops ulcers. This condition is the result of an overactive immune system. UC affects 3.3 million patients in the US, Europe and Japan². Despite broad therapeutic options, remission rates are only 25-30%³ leaving most patients without satisfactory treatments. 15% of patients⁴ fail to respond to all therapies and undergo surgery as a last option.

ABOUT OSE IMMUNOTHERAPEUTICS

OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on Euronext.

Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com. Follow us on LinkedIn.

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Forward-looking statements
This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.

These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2024, including the annual financial report for the fiscal year 2023, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

1 The abstract was submitted before the completion of the 24-week Open Label Extension (OLE) period. The new data to be presented at DDW 2025 includes additional findings not available at the time of submission.
2 Evaluate Pharma
3 Drugs Context. 2019; 8: 212572 –doi: 10.7573/dic.212572
4 Scientific Reports volume 10, Article number: 12546 (2020)

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