Isofol Medical

The information in the press release is intended for investors.

Isofol is today arranging an investor meeting where the company will present its evidence platform that forms the basis for the upcoming clinical phase Ib/II study with arfolitixorin, the preliminary study design, and a review of the market potential of arfolitixorin.

The evidence platform gathers the extensive arfolitixorin dataset generated in pre-clinical and clinical studies, and the conclusions can be summarized as follows:

• Arfolitixorin has already shown efficacy in an extensive phase III study.
• Higher doses with a new administration regimen are expected to lead to better efficacy.
• Higher doses can most likely be given without affecting the safety profile.

The data supporting the above claims have previously been presented in press releases during the year and will be presented in more detail during the investor meeting. Overall, the evidence platform strengthens the prospects for success in future studies.

The preliminary study design for the coming clinical phase Ib/II study is based on the evidence platform and is currently being discussed with relevant regulatory authorities. The main objective of the study is to document the efficacy and safety of a new dose and administration regimen with arfolitixorin as a first-line treatment for patients with metastatic colorectal cancer. The design and preliminary endpoints will be presented at the investor meeting.

The global market for treatment of metastatic colorectal cancer is expected to grow to USD 7.3 billion by 2032. The standard of care, consisting of 5-FU-based chemotherapy in combination with folate (such as arfolitixorin), is expected to remain the mainstay of first-line treatment for the foreseeable future. A recent market analysis conducted by an external consulting firm confirms Isofol's previous revenue estimates and indicates that arfolitixorin could reach blockbuster level gross sales (USD ~1 billion) in metastatic colorectal cancer in the U.S. market alone. Revenue from markets ex-U.S. or potential indication expansions is not included in this estimate.

“During the year, Isofol has generated important data that, together with previous scientific evidence, strengthened the evidence base for the continued development of arfolitixorin as one of few innovations with the potential to improve the efficacy of first-line treatment of metastatic colorectal cancer. We have recently conducted a market analysis that indicate blockbuster potential – sales of USD 1 billion – for arfolitixorin in the US market alone. In addition, we see further opportunities in indication expansion and other geographic markets where arfolitixorin can be an important improvement of today's standard treatments”, says Isofol's CEO, Petter Segelman Lindqvist.

Follow the investor meeting digitally via the link below:
https://ir.financialhearings.com/isofol-medical-november-2024/register

For more information, please contact
Isofol Medical AB (publ)
Petter Segelman Lindqvist, Chief Executive Officer
E-mail: petter.s.lindqvist@isofolmedical.com
Phone: +46 (0)739 60 12 56

The information was submitted for publication, through the agency of the contact persons set out above, at 08:00 CET on November 20, 2024.

About Isofol Medical AB (publ)
Isofol Medical AB (publ) aims to raise the quality of life and increase the survival rate for patients with severe forms of cancer. The company’s drug candidate arfolitixorin is being developed with the purpose of increasing the efficacy of standard first-line treatment for several forms of solid tumours, including colorectal cancer. The next step in the clinical development program is currently being prepared based on a new dosage regimen that is expected to optimize arfolitixorin’s efficacy. Isofol Medical AB (publ) is traded on Nasdaq Stockholm.

www.isofolmedical.com