Status of the Production Facility

• The Umeå facility was acquired in 2021 and is owned through Diamyd Medical’s wholly owned subsidiary Diamyd Biomanufacturing AB. Extensive renovations and upgrades have been carried out to tailor the facility for production.
• The premises (24,000 square feet) are fully completed, containing state-of-the-art cleanroom production areas for biological product manufacturing, a quality control laboratory, a process development laboratory, a modern goods reception area, storage and office/staff facilities.
• Storage capacity has been expanded to manage raw materials and single-use materials for multiple production batches while optimizing material flow. Space is available for future expansion with additional cleanrooms.
• All equipment for manufacturing, purification and quality control of biological substances is installed. The production areas and most equipment have been validated for API manufacturing.
• The Umeå site currently employs 17 full-time staff, with additional key personnel to join.
• A quality system implementing Good Manufacturing Practice (GMP) is in its final phase, ensuring strict oversight of manufacturing and testing.
• A fully equipped quality control laboratory is conducting process sample analyses and validation of some analytical methods to transfer testing from external facilities to in-house operations.

Production and Process Characterization
Following the FDA’s confirmation that the Phase 3 study DIAGNODE-3 meets the criteria for accelerated BLA with a readout expected around March 2026, production activities related to the GAD65 process have intensified:

• Small-scale production has provided key data for process optimization.
• Characterization of the production process is ongoing, which is necessary for process validation and an upcoming BLA.
• Large-scale technical production: Large-scale technical batches have been produced and analyzed, showing comparable results to previously externally produced GAD65 batches.
• Batch production efficiency: The production and purification of one batch of GAD65 take approximately four weeks, yielding about 3,000 doses of Diamyd^®, sufficient for treating approximately 1,000 patients.
• Storage and handling: The active pharmaceutical ingredient GAD65 is stored at temperatures below - 65°C, with a shelf life exceeding five years. Once formulated into Diamyd^®, each dose maintains stability for more than five years under specified conditions.
• Packaging and distribution: For each batch of Diamyd^® production, GAD65 is sent to an external CDMO for formulation into the final drug product in vials.

BLA preparations and regulatory compliance
To optimize resource allocation ahead of a BLA and to ensure regulatory compliance, Diamyd Medical has planned GMP certification in line with broader preparations for a U.S. market application:

• Regulatory compliance focus: Ensuring validation of all processes before submitting the marketing application.
• Cost optimization: Efficient resource allocation.
• Timeline: GMP certification by the Swedish Medical Products Agency and process characterization are key milestones for 2025. Following a BLA submission, an FDA inspection will take place.

Future Prospects and Strategic Growth
Beyond the production of the active ingredient in the antigen-specific immunotherapy Diamyd^®, the Umeå facility has the potential to become a key resource within the broader biologics manufacturing sector and national preparedness efforts. Its flexible and high-quality production capacity opens opportunities for:

• Contract manufacturing: Potential collaborations with external partners needing capacity for biological substance production.
• Analytical and product development services: Conducting analyses within the facility’s quality control laboratory and product development in the process development laboratory, in collaboration with external partners.
• Pipeline expansion: Supporting future internal projects requiring advanced biomanufacturing solutions.
• Innovation and development: Positioning Diamyd Medical as a biotechnology hub, where research and industrial production converge.

About the Manufacturing Facility
The 24,000 square feet facility is designed for high-quality and efficient biopharmaceutical production, featuring state-of-the-art cleanrooms, laboratories, and storage. The facility uses Cytiva’s FlexFactory platform with single-use technology, offering flexibility, precise process control, and scalability. The facility is well-positioned as a platform for broader biomanufacturing opportunities. The property, including the site as well as 97 000 square feet of land area, is owned by Diamyd Medical’s subsidiary Diamyd Biomanufacturing AB.

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 III 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 IIb 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.

For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
E-mail: ulf.hannelius@diamyd.com

Diamyd Medical AB (publ)
Box 7349, SE-103 90 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68
E-mail: info@diamyd.com Reg. no.: 556242-3797 Website: https://www.diamyd.com

The information was provided by the contact person above, for publication on March 19, 2025, 14:40 CET.