Quarterly Report 1 24/25
September 2024 – November 2024, Diamyd Medical AB (publ), Fiscal year 2024/2025
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 - November 30, 2024
- Net result: MSEK -36.2 (-32.8).
- Result per share: SEK -0.4 (-0.4)
- Cash flow from operating activities: MSEK -41.8 (-27.8)
- Cash and short-term investments at November 30, 2024: MSEK 152.9 (176.7).
Events during the first quarter
- ASSET publication advocated for national screening programs for early detection of Type 1 Diabetes (not yet insulin requiring Stage 1- and Stage 2 Type 1 Diabetes)
- A conference about Stage 1- and Stage 2 Type 1 Diabetes screening was organised, as part of the ASSET partnership, coordinated by Diamyd Medical
- Analysis showing robust Diamyd® treatment effects across clinical trials was presented at the 2024 IDS Diabetes Congress in Brugge
- INNODIA and Diamyd Medical announced partnership for Type 1 Diabetes awareness
- Exercise rate of 95 % of warrants, provided Diamyd Medical with SEK 48 million
- Diamyd Medical pursued accelerated approval pathway for Type 1 Diabetes precision medicine
Events after the first quarter
- Granting of patent in South Korea for insulin antigen treatment of autoimmune diabetes
- 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
Comments by CEO Ulf Hannelius
Dear Shareholders,
With full speed ahead, we continue advancing Diamyd®— our precision immunotherapy for Type 1 Diabetes — toward an FDA supported Phase-3 Study early read-out, that may be followed by an application for an accelerated market approval.
Our recently updated market analysis estimates that approximately 60,000 patients in the U.S. could be eligible for Diamyd® annually in the launch indication (i.e. newly diagnosed insulin dependent patients, Stage-3 Type 1 Diabetes). Market research indicates strong interest from payers and prescribers in targeted disease-modifying therapies, reinforcing the blockbuster potential of Diamyd®. Our genetically validated approach—-addressing the approximately 40 % of Type 1 Diabetes patients with a specific HLA genotype—aligns with the growing demand for precision medicine solutions that offer both clinical and economic benefits.
Recruitment in DIAGNODE-3, our pivotal Phase-3 study, continues to progress, with over 200 patients (more than needed for the planned early read-out in March-26) now randomized across 60 clinical sites in the U.S. and Europe.
Beyond the launch indication, we see significant commercial potential in follow-on indications, particularly Latent Autoimmune Diabetes in Adults (LADA), which represents a market opportunity expected to be equal to or larger than Stage-3 Type 1 Diabetes. LADA shares important immunological features with Type 1 Diabetes and is often diagnosed before the patient requires insulin, much like someone in the early stages (Stage 2) of Type 1 Diabetes. There is currently no approved therapy addressing its underlying disease process.
Scientific and clinical validation of Diamyd® continues to grow. At the 20th Immunology of Diabetes Society Congress, we presented an in-depth analysis demonstrating robust treatment effects across clinical trials, reinforcing the potential of Diamyd® to modify disease progression. Additionally, a peer-reviewed publication on the “redosing” DIAGNODE-B trial highlighted the safety and potential efficacy of additional injections of Diamyd®.
Patient engagement and recruitment remain a priority, and our strategic partnership with INNODIA, a leading international research network, is expected to further enhance trial visibility and patient awareness and enrollment into DIAGNODE-3
We recently expanded our Scientific Advisory Board with Dr. Emily Sims and Dr. Alice Long. With these two leading US-based researchers, we gain additional important expertise in pediatric endocrinology, translational immunology and diabetes research, which is particularly important as we are now well advanced in our clinical development program.
Our financial position was strengthened with approximately SEK 48 million raised through the exercise of series TO 3 warrants - a subscription rate of 95 %. Another opportunity for warrant exercise is in March 2025, which, if fully subscribed, would provide approximately SEK 100 million to support our clinical, regulatory and manufacturing activities as we continue preparing for a potential accelerated Biologics License Application (BLA).
FDA’s confirmation that C-peptide can serve as a reasonably likely surrogate endpoint to predict clinical benefit is a significant development for Diamyd®. With Fast Track and Orphan Drug Designations already granted, we have aligned our development program with the FDA, and the interim analysis expected in March 2026 will provide key data, with C-peptide as the primary endpoint, that may support a BLA under the accelerated approval pathway. A Type C meeting held in December with the FDA confirmed alignment on critical milestones and on the statistical plan for the accelerated approval process.
Stockholm, January 29, 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 for the prevention and treatment of Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd® is an antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production that 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 1, 2 and 3 Type 1 Diabetes. DIAGNODE-3, a confirmatory Phase III trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes at 60 sites in eight European countries and in the US. Significant results have previously been shown in a large genetically predefined patient group - in a large-scale meta-analysis as well as in the Company’s prospective European Phase IIb trial, where Diamyd® was administered directly into a superficial lymph node in children and young adults with recently diagnosed Type 1 Diabetes. Injections into a superficial lymph node can be performed in minutes and are intended to optimize the treatment response. 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 also develops the GABA-based investigational drug Remygen® as a component in the treatments of metabolic diseases. 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.
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
Informationen lämnades, genom ovanstående kontaktpersons försorg, för offentliggörande
den 29 januari 2025 kl. 08.15.
Tags:
