Regulatory press release

Modus Therapeutics publishes Interim report for the first quarter 2025

STOCKHOLM, SWEDEN – 14 May 2025: Modus Therapeutics Holding AB (“Modus Therapeutics”) hereby publishes an interim report for the first quarter of 2025. The report is available on the company’s website (www.modustx.com) and as an attachment to this release. Below is a summary of the interim report.

Clinical progress and strengthened trial infrastructure mark Q1 2025
Modus Therapeutics entered 2025 with sustained clinical momentum, achieving several key milestones in the development of sevuparin—its lead candidate targeting severe and underserved conditions such as anemia in chronic kidney disease (CKD), severe malaria, and sepsis. Patient enrollment was successfully completed in the Phase I SEVUSMART study in severe malaria, and the ongoing Phase IIa CKD-anemia trial progressed as planned, bolstered by the activation of a second study site in Italy. The company also secured bridge financing from its largest shareholder, Karolinska Development, highlighting continued confidence in its strategy and progress.

John Öhd, CEO of Modus Therapeutics, commented:
"The first quarter of 2025 underscores our commitment to advancing sevuparin for patients with urgent unmet needs. The successful completion of patient enrollment in our severe malaria study and the steady progress in our CKD-anemia trial are important steps forward. With strong support from our partners and shareholders, we are well-positioned to deliver meaningful innovation in global health."

The first quarter in figures

The loss after tax amounted to TSEK 2 815 (3 105).
The loss per share amounted to SEK 0,08 (0,09).
The cash flow from current operations was negative in the amount of TSEK 4 059 (3 665).

Important events during the first quarter

Modus Therapeutics receives a recruitment update from the collaborative SEVUSMART Phase 1b study in severe malaria.
Modus Therapeutics announces completion of patient enrollment in the SEVUSMART Phase 1b study for severe malaria.
Modus Therapeutics secures bridge financing from Karolinska Development.

Important events after the end of the period

Modus Therapeutics to present preclinical data supporting sevuparin’s effects in chronic kidney disease at BioIron 2025.
Modus Therapeutics opens second study site in ongoing Phase IIa CKD-anemia study.

CEO John Öhd will provide comments on the report in an interview with Jonathan Furelid on May 14 at 16:00.
Link to Interview: https://www.youtube.com/watch?v=5XIF4TVaJ9w

About Modus Therapeutics and sevuparin
Modus is a Swedish biotechnology company that is developing its proprietary polysaccharide sevuparin as a potential treatment for several major healthcare needs including sepsis, endotoxemia, severe malaria and other disorders with severe systemic inflammation as well as states of anemia, related to chronic inflammation such as kidney disease. There is a great need for new treatments that can effectively treat these conditions. Modus’ ambition is to create a paradigm shift in the care of these diseases, where sevuparin could provide therapeutic benefits. Modus Therapeutics is listed on the Nasdaq First North Growth market (“MODTX”). More information is available at www.modustx.com.

Sevuparin is a clinical stage, innovative proprietary polysaccharide drug with a multimodal mechanism of action, including immunomodulating, anti-adhesive and anti-aggregate effects. Sevuparin is a heparinoid with markedly attenuated anti-coagulation features that allows severalfold higher doses to be given, compared to regular heparinoids, without the associated risk for bleeding side-effects. Two routes of administration of sevuparin are currently being tested – an IV formulation for in-patient administration and a subcutaneous formulation that allows ambulatory and home care administration.