Diamyd Medical today announces in its second quarterly report for fiscal year 2024/2025 continued progress toward a transformative regulatory milestone, with early Phase 3 results from the DIAGNODE-3 trial expected in March 2026. The trial is on track for full enrollment in 2025, alongside planned GMP certification of the Company's biomanufacturing facility in Umeå. Following internal strategic discussions and input from its Scientific Advisory Board, Diamyd Medical is also expanding its precision medicine platform and evaluating the inclusion of the LADA (Latent Autoimmune Diabetes in Adults) population in future indications. Subscription commitments in the ongoing rights issue amount to approximately SEK 44.1 million.
Precision Medicine for Autoimmune Diabetes
Aiming for Accelerated Market Approval
Diamyd Medical's B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B.
Further information is available on https://www.diamyd.com
September 1, 2024 - February 28, 2025
- Net income: MSEK 0.1 (0.0), second quarter: MSEK 0.0 (0.0)
- Net result: MSEK -81.0 (-62.0), second quarter: MSEK -44.9 (-29.3)
- Result per share: SEK -0.8 (-0.7), second quarter: SEK -0.4 (-0.3)
- Cash flow from operating activities: MSEK -90.2 (-63.2), second quarter: MSEK -48.4 (-35.4)
- Cash and short-term investments at February 28, 2025: MSEK 103.8 (137.1).
Significant events during the second quarter
- The Board of Directors resolved on a rights issue
Other events during the second quarter
- Granting of precision medicine patent for prevention and treatment of autoimmune diabetes in Mexico
- Diamyd Medical's CFO will leave in 2025
- Diamyd Medical announced additional financial support from Breakthrough T1D
- Granting of patent for insulin antigen treatment of autoimmune diabetes in South Korea
- Diamyd Medical gave an update on the U.S. market potential for Diamyd®
- Diamyd Medical cleared pathway to accelerated approval for Diamyd® following a meeting with the FDA
- A publication highlighted potential benefits of redosing Diamyd® precision medicine for Type 1 Diabetes
- Renowned researchers Emily Sims and Alice Long joined Diamyd Medical's Scientific Advisory Board
- Diamyd Medical aligned with FDA on key elements for an accelerated approval process
Events after the second quarter
- Diamyd Medical plans for GMP Certification in 2025
- Diamyd Medical highlighted clinical benefits of C-peptide preservation at ATTD 2025
- Diamyd Medical advanced AI-powered screening for Type 1 Diabetes within the Vinnova financed ASSET Project
- Additional subscription commitments for the rights issue were made
Comments by CEO Ulf Hannelius
Dear Shareholders,
We are well into 2025 with strong momentum across our strategic pillars - clinical development, regulatory alignment, AI-driven screening, biomanufacturing and financing. The progress we are making brings us closer to a transformative milestone: the expected early readout from our Phase 3 trial DIAGNODE-3 in one year's time.
Regulatory alignment in the U.S. and in Europe
Clinically and regulatorily, we are advancing with clear alignment from both the U.S. FDA and the European EMA. DIAGNODE-3 is designed to serve as a single pivotal trial supporting potential market approvals on both sides of the Atlantic. In the U.S., we have reached a landmark agreement with the FDA that the early readout planned for March 2026 may serve as the basis for a Biologics License Application (BLA) under the accelerated approval pathway. This alignment - centered on the use of C-peptide as a reasonably likely surrogate endpoint - represents a major advancement not only for Diamyd Medical, but for the entire Type 1 Diabetes field, where precision immunotherapies are emerging as the next frontier of care.
The trial evaluates our investigational immunotherapy Diamyd® in recently diagnosed individuals with Type 1 Diabetes who carry the HLA DR3-DQ2 genotype - a genetically defined subgroup that represents approximately 40 % of all patients with the disease. The significance of this subgroup was further underscored at the ATTD 2025 conference, recently held in Amsterdam, the Netherlands, where we presented new analyses demonstrating strong associations between preserved C-peptide (remaining own insulin production) and improved glycemic outcomes, including lower blood sugar levels and enhanced Continuing Glucose Measuring metrics?.
With 216 patients randomized to date, of which 31 have completed the entire study (24-month follow-up) and 77 have completed their 15-month visit, we look forward to full enrollment of the study in 2025 and a data readout to support an accelerated approval pathway in March 2026.
Expanding the Type 1 Diabetes indication
As part of our ongoing strategic planning, we recently convened a meeting with our Scientific Advisory Board, which includes internationally recognized experts in Type 1 Diabetes. The discussions reinforced our precision medicine approach and helped shape the next phase of our development roadmap. A key theme was the inclusion of Latent Autoimmune Diabetes in Adults (LADA) under the broader clinical and regulatory umbrella of Type 1 Diabetes - a direction now also reflected in the updated guidelines from the American Diabetes Association. LADA shares important immunological features with Type 1 Diabetes and is increasingly understood as part of the same disease spectrum, albeit with a more heterogeneous onset and course. Based on this, we are evaluating the possibility of including LADA in a future label indication for Diamyd®, without the need for separate clinical trials, further supported by previously generated data in older individuals with recent-onset autoimmune diabetes.
Prevention and platform expansion targeting DR4-DQ8
The Scientific Advisory Board also discussed Diamyd's® unique clinical profile - demonstrating long-lasting preservation of insulin-producing capacity after only three injections and a favorable safety profile in over 1,000 treated individuals. As a clear example of this, only one study participant has so far discontinued their participation in DIAGNODE-3, and this was unrelated to the treatment. This strongly supports the use of Diamyd® also for preventive purposes, i.e., for the treatment of presymptomatic Type 1 Diabetes, also known as Stage 1 and Stage 2 Type 1 Diabetes. This also supports the broadening of Diamyd Medical's precision immunotherapy platform where preparations are underway for the development of an insulin peptide-based antigen-specific therapy targeting individuals with the DR4-DQ8 genotype, the other major genetic subgroup in Type 1 Diabetes. This initiative is being positioned to advance in parallel with the final stages of DIAGNODE-3, with the aim of enabling rapid development beyond the March 2026 readout.
AI-Driven early detection and individualized care
Our focus remains on delivering safe, convenient, and durable immunotherapies that intervene early in the disease process - preserving endogenous insulin production and altering the trajectory of disease. These developments further reinforce the potential of a precision medicine ecosystem in Type 1 Diabetes that addresses the root cause of disease across genetic subtypes and clinical presentations. We are also making important strides in early detection and individualized care. Through the ASSET project, a Vinnova-funded initiative led by Diamyd Medical and AI partner MainlyAI, we are building advanced survival prediction models to personalize screening and follow-up strategies in Type 1 Diabetes?. These tools use genetic and clinical data to anticipate disease onset at the individual level, supporting the future implementation of a precision medicine ecosystem where risk assessment, diagnosis, and treatment are seamlessly integrated.
Manufacturing readiness and long-term capability
In Umeå, our biomanufacturing facility continues to deliver. Technical batches of GAD65, the active ingredient in Diamyd®, have been successfully produced and analyzed, and formulation into drug product has been made. Preparations for Good Manufacturing Practice (GMP) certification are entering their final phase - this certification will be a key milestone on the path toward a potential BLA. At the same time, the Umeå facility presents broader opportunities as a national asset for biologics manufacturing, with capabilities that extend to contract production, analytical services, future internal pipeline development and national preparedness.
Strengthened financial position for the next phase
To support these milestones, we have launched a preferential rights issue of approximately SEK 208 million, which includes one warrant (TO 5) per share exercisable in April 2026 - shortly after the planned Phase 3 readout. The structure ensures that investors have the opportunity to participate in the next phase of Diamyd Medical's growth. Subscription commitments and intentions now cover approximately SEK 44.1 million, with strong participation from management and long-term shareholders??.
We are also proud to have been granted additional non-dilutive funding of USD 1.75 million from Breakthrough T1D (formerly JDRF), bringing their total support to USD 6.75 million. This includes a milestone payment of USD 750,000 received during March.
Looking ahead
With a pivotal regulatory milestone just one year away, Diamyd Medical stands at the forefront of a new era in autoimmune diabetes. We remain fully focused on execution, and with aligned regulatory frameworks, expanding clinical and manufacturing infrastructure, and an ecosystem of precision medicine innovations, we are advancing confidently toward our goal: to deliver a safe, effective, and transformative therapy for individuals affected by this chronic disease.
Stockholm, April 9, 2025
Ulf Hannelius, 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 develops precision medicine therapies to prevent and treat Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd® is an investigational antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production specifically for individuals carrying a HLA DR3-DQ2 gene. Diamyd® has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (clinically diagnosed symptomatic) Type 1 Diabetes. Diamyd® has also been granted Fast Track Designation for the treatment of Stage 1 and 2 (pre-symptomatic) Type 1 Diabetes. DIAGNODE-3, a confirmatory Phase 3 trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes at 60 clinics in eight European countries and in the US. Significant results in preserving endogenous insulin production have previously been shown in a large genetically predefined patient group - both in a large-scale meta-analysis as well as in the Company's prospective European Phase 2b trial. The DIAGNODE-3 trial is recruiting only this patient group that carries the common genotype known as HLA DR3-DQ2, which constitutes approximately 40 % of patients with Type 1 Diabetes in Europe and the US. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy Diamyd®. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB.
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:
Ulf Hannelius, President and CEO, ulf.hannelius@diamyd.com
Anna Styrud, CFO, anna.styrud@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 person set out above,
at 08.15 CET on April 9, 2025.
