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