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Press release

Isofol completes first cohort in ongoing clinical study with arfolitixorin

Isofol Medical

GOTHENBURG, Sweden, June 12, 2025 - Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), announces today that the company has completed the first cohort in the ongoing phase Ib/II clinical study with arfolitixorin that is carried out at Charité – Universitätsmedizin Berlin. The company is now preparing to initiate the next cohort in the dose-escalating part of the study.

The information in the press release is intended for investors.

Isofol is developing the drug candidate arfolitixorin as a new potential treatment of advanced forms of cancer. A phase Ib/II clinical study carried out at Charité – Universitätsmedizin Berlin evaluates arfolitixorin as a treatment for patients with metastatic colorectal cancer, the third most common form of cancer globally, according to the World Health Organization, WHO.

The study is conducted in two steps, whereas the first part, phase Ib, evaluates increasing doses of the drug candidate. Following a meeting with the Safety Review Committee, the company has received recommendation to proceed to the next dose cohort.

“We are happy to receive the positive outcome from the Safety Review Committee meeting and that the study is developing according to plan. The completion of the first patient cohort is an important milestone, and we are looking forward to evaluating the next dose level,” says Roger Tell, Chief Medical Officer at Isofol.

For more information, please contact
Isofol Medical AB (publ)
Roger Tell, Chief Medical Officer
E-mail: roger.tell@isofolmedical.com
Phone: +46 (0)760 29 39 11

The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CEST, on June 12, 2025.

About Isofol Medical AB (publ)
Isofol Medical AB (publ) works to improve the quality of life and prognosis for patients with severe forms of cancer. The company's drug candidate arfolitixorin aims to increase the effect of first-line standard treatment for several forms of solid tumors and is currently being studied in colorectal cancer, the world's third most common cancer, where the medical need for better treatments is truly urgent. A phase Ib/II study is now being conducted with new a dosage regimen that are expected to optimize the effect of the drug candidate. Isofol Medical AB (publ) is traded on Nasdaq Stockholm.

www.isofolmedical.com

Attachments
20250612_PM_Isofol_Cohort I

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