STOCKHOLM, SWEDEN - 26 November 2025: Modus Therapeutics Holding AB ("Modus Therapeutics") hereby publishes an interim report for the third 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 execution and capital strength define Q3 2025
Modus Therapeutics advanced its CKD-anemia program in the third quarter, completing enrolment of Part 1 in the ongoing Phase IIa study and selecting doses for Part 2. The fully underwritten rights issue was oversubscribed to 189%, adding ~SEK 28.3 million in gross proceeds and, together with warrants, extending the funded runway through end-2026. New preclinical data presented by our Brescia collaborators further reinforced the insights of sevuparin's hepcidin-lowering mechanism and potential benefit in CKD with anemia. After period-end, Italian authorities approved the predetermined protocol amendment for Part 2, enabling initiation of the repeat-dose PoC phase as planned. Building on the momentum from Q2-when Part 1 was completed and the rights issue was approved-we remain focused on disciplined execution and value creation.
"Strong clinical delivery, an oversubscribed financing and clear regulatory progress set us up to execute Part 2 with confidence and drive long-term value for patients and shareholders."
- John Öhd, CEO, Modus Therapeutics
The third quarter in figures
- The loss after tax amounted to TSEK 4 342 (2 989).
- The loss per share amounted to SEK 0,08 (0,08).
- The cash flow from current operations was negative in the amount of TSEK 5 590 (3 971).
The first 9-months in figures
- The loss after tax amounted to TSEK 13 223 (10 831).
- The loss per share amounted to SEK 0,31 (0,30).
- The cash flow from current operations was negative in the amount of TSEK 13 072 (11 060).
Important events during the third quarter
- Patient enrolment for Part 1 of the ongoing Phase IIa study of sevuparin in chronic-kidney disease (CKD) anemia was completed on schedule (press release 8 July 2025); the singledose safety data and future dose levels identified here will guide Part 2, planned to begin Q4 2025.
- Extraordinary General Meeting (29 July 2025) approved: (i) new share-capital and share-number limits in the articles of association, (ii) a fully underwritten rights issue of up to 8 984 724 units (~ SEK 28.3 million gross) priced at SEK 3.15 per unit, and (iii) an issue authorisation for additional shares and warrants.
- Sevuparin doses selected for Part 2 of the ongoing Phase IIa study in CKD anemia; a predetermined protocol amendment submitted to regulatory authorities (press release August 1, 2025).
- On 27 Aug 2025, the fully underwritten rights issue of up to 8,984,724 units was oversubscribed to 189% (no guarantees utilized), providing ~SEK 28.3m gross (~SEK 24.4m net) to fund ongoing clinical activities, including the Phase II CKD-anemia study, and extend the cash runway through end-2026.
- On 2 Sep 2025, Modus executed a directed compensation issue to the guarantors; all opted for units instead of 14% cash-536,342 units at SEK 3.15 (~SEK 1.7m via set-off)-adding 4,827,078 shares post-registration (~4% dilution) and implying ~7% potential dilution upon full exercise of TO 2026/2030.
- On 20 Sep 2025, Prof. Maura Poli (Brescia) presented preclinical data at the 32nd GAG Symposium (Villa Vigoni) showing sevuparin improved anemia and kidney function in a CKD model-also with EPO-with reduced fibrosis; results reinforce the hepcidin-lowering mechanism and build on BioIron/EHA 2025.
Important events after the end of the period
- On 24 Oct 2025, Modus appointed Bergs Securities AB as Certified Adviser; Bergs assumes the role on 27 Oct 2025, with Svensk Kapitalmarknadsgranskning AB (SKMG) continuing until then.
- On 4 Nov 2025, Italian authorities approved the protocol amendment with dose selection for Part 2 of the Phase IIa CKD-anemia study; three sevuparin doses were set based on Part 1 (well tolerated), enabling repeat-dose/PoC initiation in Q4 2025 as planned.
CEO John Öhd will provide comments on the report in an interview with Jonathan Furelid on November 26 at 10:00.
Link to Interview: https://www.youtube.com/live/mpZKm4NDm-o'si=RwcANQz9azZDIAdc
For more information on Modus Therapeutics, please contact:
John Öhd, CEO, Modus Therapeutics
Phone: +46 (0) 70 766 80 97
Email: john.ohd@modustx.com
This information is information that Modus Therapeutics Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-11-26 08:00 CET.
Certified Adviser
Bergs Securities AB
Hemsida: www.bergssecurities.se
About Modus Therapeutics and sevuparin
Modus is a Swedish biotech company developing its patented polysaccharide, sevuparin, as a treatment option for several major unmet medical needs, including anemia in kidney disease and other chronic inflammatory conditions, severe malaria, sepsis, and other disorders involving severe systemic inflammation. 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.