Quarterly Report 3 25/26
September 2025 – May 2026, Diamyd Medical AB (publ), Fiscal year 2025/2026
Diamyd Medical
Diamyd Medical is a Swedish biotechnology company focused on precision medicine approaches for type 1 diabetes and biological manufacturing. The Company has established a facility for manufacturing of biological products in Umeå, Sweden.
Diamyd Medical’s B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser. Further information is available on https://www.diamyd.com
September 1, 2025 – May 31, 2026
- Net sales: MSEK 0.4 (0.1), third quarter MSEK 0.1 (0.0)
- Net result: MSEK -238,8 (-124.9), third quarter MSEK -127.1 (-43.9) impacted by a provision corresponding to approximately 71 MSEK during the third quarter for close-down costs related to DIAGNODE-3
- Result per share before and after dilution: SEK -0.8 (-1.2), third quarter: SEK -1.7 (-0.4)
- Cash flow from operating activities: MSEK -154.9 (-133.7), third quarter MSEK -71.7 (-43.5)
- Cash and short-term investments at May 31, 2026: MSEK 346.4 (319.3)
Events during the third quarter
- Diamyd Medical announced that Niklas Axelsson has decided to leave his position as CFO
- Diamyd Medical received GMP certification and manufacturing authorization for biological investigational medicinal products for human use
- Diamyd Medical provided an update on strategic review and financial position
- Diamyd Medical strengthened its position in the manufacturing of biological medicines
- Diamyd Medical announced that Ulf Hannelius has decided to leave his position as CEO upon which Anders Essen-Möller has been reappointed to this position, and Erik Nerpin has been reappointed as Chairman of the Board
- Diamyd Medical discontinued DIAGNODE-3 following evaluation confirming futility and initiated strategic review
- Diamyd Medical provided updates on the interim efficacy analysis of Phase 3 DIAGNODE-3 trial
- Diamyd Medical reported negative interim results of Phase 3 DIAGNODE-3 trial
- Diamyd Medical entered into equity financing agreements with new U.S. sector specialist investors for up to USD 125 million and announced full enrolment in Phase 3 trial
- Diamyd Medical received Notice of Grant in Japan for insulin-based antigen therapy patent in type 1 diabetes
- Diamyd Medical finalized the database for interim analysis readout in DIAGNODE-3 trial
- Diamyd Medical announced the strengthening of its IP-position in the US
Other events after the third quarter
- Diamyd Medical provided an update regarding Strategic Overview
- Diamyd Medical provided an update regarding interim CFO
- Diamyd Medical received Notice of Allowance for Key Precision Medicine Patent in the US
- Diamyd Medical provided an update on ongoing activities
Comments by CEO Anders Essen-Möller
Dear Shareholders,
The past quarter has been one of the most challenging periods in Diamyd Medical’s history. Following the pre-specified interim analysis of our confirmatory Phase 3 trial DIAGNODE-3, we announced March 27, that the study yielded results that were totally unexpected and not aligned with prior retrospective or prospective data. Subsequent evaluation confirmed that the pre-specified futility criteria had been met, leading to the difficult but necessary decision to discontinue the trial.
This result is deeply disappointing for everyone involved — especially for patients, investigators, study teams, employees and shareholders who have supported our mission over many years. Following review of data, randomization procedures and statistical assumptions, no factors have yet been identified that materially altered the interpretation of the interim results. Importantly, no new safety concerns were observed, and retogatein continued to demonstrate a favorable safety profile. The review of data is still ongoing.
During the quarter, CEO Ulf Hannelius and CFO Niklas Axelsson decided to leave their positions and as a consequence, I was appointed to retake the position as CEO. Erik Nerpin – previously vice Chairman of the Board – was reappointed as Chairman of the Board. Most employees in the Stockholm office have been put on notice. Subsequent a provision of approximately 71 MSEK that has been made during the quarter related to close-down costs of the DIAGNODE-3 study, we expect our cost base to reduce and leave us with a cash position north of 200 MSEK by the end of this year, and with our Biomanufacturing unit in Umea remaining intact.
Times are really tough currently. Whilst I do not wish anybody to go through what we currently are experiencing, I feel the need to step in as the CEO. At least for a short while. Yes, I am an old man. But with some experience. Let’s see how we can recover and regain shareholder value. In the meantime, please let me express my most sincere gratitude to all of us, unbelievable dedicated and amazing employees and shareholders.
Following the outcome of the DIAGNODE-3 study, the Company’s immediate priority is to complete the close-out of the Phase 3 program in an efficient and responsible manner.
Upon completion of this process, the Board intends to focus on evaluating opportunities to deploy the Company’s strong cash position in ways that can maximize long-term shareholder value. The Company will remain open to investments, partnerships, and strategic opportunities both within and outside the healthcare sector.
At the same time, the Company will maintain its GMP-certified biomanufacturing facility in Umea and continue efforts to secure external interest from potential acquirers, customers, partners, and projects that can utilize the facility’s capabilities.
The Company will also preserve and seek to maximize the value of its Precision Medicine platform and intellectual property portfolio in autoimmune diabetes. Future development activities related to GAD-based therapies will primarily be pursued together with external funding sources, including grants, collaborations, and strategic partnerships, with the goal of minimizing capital requirements while preserving potential upside.
The Board believes this approach provides the greatest flexibility to preserve capital, evaluate new opportunities, and maximize value for shareholders.
Again, I would like to express my sincere gratitude to our employees, investigators, study teams, collaborators, patients and shareholders for your continued support and dedication during this challenging period.
Stockholm, June 24, 2026
Anders Essen-Möller, President and CEO
*** The above is an excerpt from the report. To read the complete report, please visit https://www.diamyd.com, or see attached PDF ***
About Diamyd Medical
Diamyd Medical is a Swedish biotechnology company focused on precision medicine approaches for type 1 diabetes and biological manufacturing. The Company has established a facility for manufacturing of biological products in Umeå, Sweden.
Diamyd Medical’s B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser. Further information is available on https://www.diamyd.com
For more information, please contact:
Anders Essen-Möller, President and CEO, anders.essen-moller@diamyd.com
Diamyd Medical AB (publ), Box 7349, SE-103 90 Stockholm, Sweden
Phone: +46 8 661 00 26 E-mail: info@diamyd.com Reg. no: 556242-3797
The information was submitted for publication, through the agency of the contact persons set out above,
at 08.15 CET on June 24, 2026.
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