Interim report
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Diamyd Medical AB (publ) Box 7349 • SE-103 90 Stockholm, Sweden • Phone +46 8-661 00 26 www.diamyd.com • info@diamyd.com QUARTERLY REPORT 3 September 2024 – Maj 2025 Diamyd Medical AB (publ), Fiscal year 2024/2025 Precision Medicine for Autoimmune Diabetes Aiming for Accelerated Market Approval Autoimmune or Type-1 Diabetes (T1D) is a progressive disease, diagnosed as at least two antibodies to the insulin producing beta cells are found. The disease advances to Stage-3 where the patient requires daily insulin administrations for survival. LADA (latent autoimmune diabetes in the adult), formerly often misdiagnosed as Type 2 Diabetes, is today reclassified as a form of Type 1 Diabetes. 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
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DIAMYD MEDICAL AB QUARTERLY REPORT 3 September 2024 – May 2025 2 September 1, 2024 – May 31, 2025 • Net income: MSEK 0.1 (0.1), third quarter: MSEK 0.0 (0.1) • Net result: MSEK -124.9 (-102.1), third quarter: MSEK -43.9 (-40.1) • Result per share before and after dilution: SEK -1.2 (-1.1), third quarter: SEK -0.4 (-0.4) • Cash flow from operating activities: MSEK -133.7 (-100.0), third quarter: MSEK -43.5 (-36.8) • Cash and short-term investments at May 31, 2025: MSEK 319.3 (162.4), of which approximately MSEK 267 before issue costs were received in an oversubscribed rights issue and in a direct issue during the third quarter. Significant events during the third quarter • Diamyd Medical expanded a rights issue with a directed new issue of SEK 41.6 million • Diamyd Medical's rights issue was oversubscribed and raised SEK 225 million before issue costs. Other events during the third quarter • Diamyd Medical appointed Niklas Axelsson as CFO • Europe grants precision medicine patent to Diamyd Medical for insulin antigen treatment in autoimmune diabetes • DIAGNODE-3 cleared second-to-last safety review ahead of early readout in March 2026 • The prevention trial DiaPrecise with Diamyd® clears first safety milestone • Australia granted Diamyd Medical patent for novel antigen combination in autoimmune diabetes treatment • 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 Other events after the third quarter • Diamyd Medical participated in two key US Diabetes events “As we count down the months to the pivotal Phase 3 readout, our conviction grows stronger that Diamyd ® may become the first precision immunotherapy approved for Type 1 Diabetes.” Ulf Hannelius, CEO
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DIAMYD MEDICAL AB QUARTERLY REPORT 3 September 2024 – May 2025 3 Comments by CEO Ulf Hannelius Dear Shareholders, As we move into the second half of 2025, our preparations for the anticipated Phase 3 readout of DIAGNODE -3 continue at full pace, reinforced by a solid financial base, an expanding organization, and robust progress across all operational fronts. In a capital market marked by cautious investor sentiment, Diamyd Medical has secured significant new funding under exceptionally favorable conditions. The recently completed preferential rights issue, complemented by a direct new share issue, provided the Company with approximately SEK 267 million before issue costs. This strengthens our cash position at a critical time—approximately nine months before the expected early readout of DIAGNODE-3—and provides flexibility to accelerate activities across clinical development, business development, and regulatory planning. Recruitment into DIAGNODE-3 continues according to plan, with 250 patients now randomized and patient screening expected to be completed this calendar year. The trial recently cleared its fifth safety review by the independent Data Safety Monitoring Board (DSMB) with no concerns, reaffirming the favorable safety profile of Diamyd ® . This represents the second-to-last scheduled safety review before early readout, which may form the basis of a Biologics License Application under the U.S. FDA's accelerated approval pathway. In parallel, our DiaPrecise prevention trial evaluating Diamyd ® in children and adolescents with presymptomatic Type 1 Diabetes also cleared its first safety review, marking a new milestone in the development of preventive immunotherapy for autoimmune diabetes. In Umeå, we prepare for GMP readiness and inspection by the Swedish Medical Products Agency (MPA) later this year. This is an important milestone for the manufacturing facility and for future inspections during a BLA (marketing application) process. Diamyd Medical continues to contribute to advancing scientific and regulatory dialogue in the field of Type 1 Diabetes. I had the honor to participate in the panel for Critical Path Institute’s workshop, “21st Century Trials in New-Onset Type 1 Diabetes,” which brought together regulators, researchers, clinicians and industry stakeholders to align on the use of C-peptide as a primary endpoint in disease-modifying trials. Our experience with DIAGNODE-3, where C-peptide serves as the principal endpoint, provided a valuable case study to inform this important regulatory discourse. We were also present at the ADA 2025 Scientific Sessions in Chicago last week, where we co-hosted a breakfast panel with Breakthrough T1D (formerly JDRF) titled “Precision in Diagnosis, Power in Treatment: The Future of Type 1 Diabetes”. The panel included thought leaders from clinical research, regulatory science and patient advocacy to explore the evolving landscape of precision immunotherapies. Together, these platforms underscore our growing role as a frontrunner in shaping the future of care for autoimmune diabetes. As we count down the months to the early Phase 3 readout, my conviction grows stronger that Diamyd ® may become the first precision immunotherapy approved for Type 1 Diabetes. Diamyd Medical’s strategy is sharply focused: to deliver a safe, durable, and genetically guided therapy that transforms the standard of care for autoimmune diabetes. Thank you for your continued support as we work to realize this vision. Stockholm, June 25, 2025 Ulf Hannelius, President and CEO
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DIAMYD MEDICAL AB QUARTERLY REPORT 3 September 2024 – May 2025 4 Significant events during the third quarter March 1, 2025 – May 31, 2025 Diamyd Medical expanded a rights issue with a directed new issue of SEK 41.6 million Diamyd Medical completed a rights issue on April 30, which, including an extension issue, provide d the Company with approximately SEK 225 million before deduction of issue costs. Diamyd Medical thereafter decided to increase the rights issue by an additional SEK 41.6 million through a directed new issue of 5,200,000 B shares and 5,200,000 warrants of series TO 5 B. The directed new issue was carried out on the same terms as the rights issue, i.e. SEK 8.00 for one B share and one warrant of series TO 5 B. The directed new issue was subscribed for by Swedish and international qualified private investors. Diamyd Medical announced the outcome of SEK 225 million in an oversubscribed rights issue The final outcome, after adjustment, showed that a total of 28,201,227 units, corresponding to approximately 108 percent of the rights issue, had been subscribed for. Due to the rights issue being oversubscribed, the Board of Directors resolved on an additional unit issue through a supplementary directed issue of 2,334,103 B -units. Consequently, the Company, through the rights issue and the additional unit issue received issue proceeds of approximately SEK 225 million before issue costs. Other events during the third quarter March 1, 2025 – May 31, 2025 Diamyd Medical appointed Niklas Axelsson as CFO Niklas Axelsson will assume his position in August and will also join the management team. Niklas Axelsson brings more than 25 years of experience across the pharmaceutical, biotech, and financial sectors Europe grants precision medicine patent to Diamyd Medical for insulin antigen treatment in autoimmune diabetes The European Patent Office informed Diamyd Medical that the patent application protecting the use of insulin - based antigens for the treatment of autoimmune diabetes in patients carrying the HLA DR4 -DQ8 genetic marker will be granted. The patent, valid until 2035, marks an important step in advancing precision medicine for diabetes care. Diamyd Medical’s pivotal Phase 3 Type 1 Diabetes trial cleared second-to-last safety review ahead of early readout in March 2026 The independent Data Safety Monitoring Board (DSMB) completed its fifth scheduled safety review of Diamyd Medical’s registrational Phase 3 trial, DIAGNODE-3, evaluating the precision medicine immunotherapy Diamyd ® . The review identified no safety concerns and resulted in a recommendation to continue the trial as planned . The prevention trial DiaPrecise with Diamyd ® cleared first safety milestone The first safety review in the ongoing DiaPrecise trial in individuals with Stage 1 and Stage 2 Type 1 Diabetes was successfully completed by the independent Data Safety Monitoring Board (DSMB), following treatment of the initial three participants. The DSMB reported no safety concerns related to the injection procedure or investigational medicine, supporting continued subject enrolment. Additional participants are currently in the screening phase. Australia granted Diamyd Medical patent for novel antigen combination in autoimmune diabetes treatment The Australian Patent Office granted a patent protecting a novel immunotherapeutic composition developed by Diamyd Medical for use in the treatment and prevention of autoimmune diabetes. The patent, valid until 2035, covers a composition comprising the antigens glutamic acid decarboxylase (GAD) and proinsulin immobilized on separate carrier particles. Diamyd Medical plans for GMP certification in 2025 Process validation, stability studies and other activities for GMP production of the active pharmaceutical ingredient GAD65 are ongoing to finalize all aspects regarding manufacturing, which is required for submitting a Biologics Licensing Application (BLA) for the Company’s investigational medicine Diamyd ® . Full-scale technical batches of
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DIAMYD MEDICAL AB QUARTERLY REPORT 3 September 2024 – May 2025 5 GAD65 have been produced at the wholly owned biopharmaceutical manufacturing facility in Umeå. Active pharmaceutical ingredient (API) has thereafter been formulated into Diamyd ® and dispensed into vials by an external Contract Development and Manufacturing Organization (CDMO). Diamyd Medical highlighted clinical benefits of C-peptide preservation at ATTD 2025 Diamyd Medical presented analyses of clinical data from trials in Type 1 Diabetes at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in Amsterdam. The analyses, highlighting significant correlation between C-peptide secretion and glycemic benefits, are part of the ongoing preparations ahead of Diamyd Medical’s Phase 3 readout expected around March 2026 where C-peptide will serve as the primary endpoint to support a potential accelerated Biologics License Application (BLA) in the US. Progress in AI-powered screening for Type 1 Diabetes within the ASSET Project Diamyd Medical, in collaboration with Mainly AI and ASSET partners, highlighted meaningful progress in AI- driven screening and risk prediction for Type 1 Diabetes at the ATTD conference in Amsterdam. Dr. Gun Forsander (Institute for Clinical Sciences, Sahlgrenska Academy) presented the findings at an invited presentation at the industry symposium sponsored by Sanofi: BRIDGE TO THE FUTURE, Exploring How Innovation Can Evolve the Early Detection and Management of T1D. Other events after the period Diamyd Medical participated in two key US diabetes events Diamyd Medical participated in two significant events in the field of diabetes in June; the Critical Path Institute (C- path) Workshop: 21st Century Trials in New-Onset T1D, on June 17-18, and the American Diabetes Association's (ADA) 85th Scientific Sessions held in Chicago, US, on June 20-23.
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DIAMYD MEDICAL AB QUARTERLY REPORT 3 September 2024 – May 2025 6 Drugs in clinical development Diamyd ® is an antigen-specific immunomodulating precision medicine therapy for the treatment and prevention of Type 1 Diabetes. 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. Clinical data indicate the potential of Diamyd ® to halt or stop the autoimmune destruction of insulin-producing beta cells in individuals that carry the HLA DR3-DQ2 haplotype gene. The effect is achieved by antigen-specific reprogramming of immune cells by administration of low doses of Diamyd ® in superficial lymph nodes. By maintaining the endogenous insulin production, Diamyd ® has the potential to make a significant difference in the daily life of patients as well as significantly reducing the complications of Type 1 Diabetes. Topline results from the Phase 2b trial DIAGNODE-2 demonstrated a significant treatment effect of Diamyd ® in the predefined genetic patient group. A single confirmatory Phase 3 trial, DIAGNODE-3, aligned with the FDA and EMA, is on-going in Stage 3 Type 1 Diabetes. Remygen ® is an oral GABA-based regenerative and immunomodulatory drug candidate for the treatment of autoimmune- and type 2 diabetes. The safety of Remygen ® has been demonstrated in a Phase 1/2 clinical trial with Remygen ® in patients who have had Type 1 Diabetes for several years. In addition to safety, the study also collected data on restoring or stimulating the body's insulin production and preventing hypoglycaemia. Diamyd ® and Remygen ® are drugs in clinical development that focus on the underlying disease mechanisms of diabetes; the dysfunction and loss of insulin-producing beta cells in the pancreas.
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DIAMYD MEDICAL AB QUARTERLY REPORT 3 September 2024 – May 2025 7 Clinical trials Type 1 Diabetes is a devastating disease which requires daily treatment with insulin to sustain life. The importance of finding a drug that improves the prospects for patients with diabetes is of utmost importance. The effect of intralymphatic administration of Diamyd ® , an antigen-specific precision medicine immunotherapy aimed at stopping the immune system's attack on insulin-producing beta cells in autoimmune diabetes, is evaluated in the Phase 3 trial DIAGNODE-3 and in the Phase 2 trial DiaPrecise. Ongoing clinical trials DIAGNODE-3 – Diamyd ® in Stage 3 Type 1 Diabetes The placebo-controlled Phase 3 trial DIAGNODE-3 will include approximately 330 individuals aged 12 to 29 who have been recently diagnosed with Type 1 Diabetes (so called Stage 3 Type 1 Diabetes) and who carry the genetically defined haplotype HLA DR3-DQ2. The trial is currently ongoing at approximately 60 clinics in eight European countries and the United States, where about 40 % of all individuals with Type 1 Diabetes are estimated to carry the target haplotype. After an initial month in which all trial participants receive vitamin D, the individuals will be randomized 2:1, i.e. two out of three trial participants will receive three intralymphatic injections of Diamyd ® and one in three will receive the corresponding placebo at one-month intervals, with one primary reading 24 months after trial start. The design provides, based on efficacy data from previous studies on the HLA- restricted patient population, a high probability of reaching the primary endpoints; preservation of stimulated C- peptide and lower HbA1c. The Coordinating Investigator for the trial is Professor Johnny Ludvigsson at Linköping University. The Sponsor of the trial is Diamyd Medical. DiaPrecise – Diamyd ® in Stage 1 and Stage 2 Type 1 Diabetes DiaPrecise is an open-label clinical trial where Diamyd ® (GAD-alum) is given directly into a lymph node in 10 to 16 children aged 8 to 18 years who are at high risk of being diagnosed with clinical Type 1 Diabetes (so called Stage 1 or Stage 2 Type 1 Diabetes), and who also carry the genetically defined haploty pe HLA DR3-DQ2, associated with clinical response to Diamyd ® . The aim of the trial is to evaluate the safety and feasibility of two or three intralymphatic injections with Diamyd ® as well as the effect on the immune system and clinical parameters including endogenous insulin production and blood glucose control. The Principal Investigator of DiaPrecise is Dr. Markus Lundgren, Researcher at the Department of Clinical Sciences at Lund University and consultant pediatrician at Kristianstad hospital, Sweden. Sponsor of the trial is Diamyd Medical.
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DIAMYD MEDICAL AB QUARTERLY REPORT 3 September 2024 – May 2025 8 Biomanufacturing in Umeå A facility for manufacturing of biological products has been established in Umeå, Sweden. The primary purpose is the manufacture of recombinant GAD65, the active pharmaceutical ingredient (API) in the investigational medicine Diamyd ® , an antigen-specific immunotherapy currently in late-stage clinical development. The long-term goal for the facility is to serve as the commercial API production unit for Diamyd ® , as well as to be a key player in the production of biological substances for other drug projects. The 24 000 square feet site, comprising clean rooms, laboratory facilities, warehousing and office space, facilitates full control, predictability and scalability of the manufacturing technology of the API manufacturing technology. Diamyd Medical has chosen Cytiva’s configurable single-use bioprocess manufacturing platform FlexFactory for the process that is based on a baculovirus-insect cell expression system. Large-scale technical production of GAD65 has been produced, and continued activities aim at reliably and reproducibly manufacture GAD65 at the quality and scale required to meet regulatory demands and future market needs. Additional biomanufacturing projects, both for internal and external opportunities, will be evaluated to make full use of the site, platform, analytical laboratory and competencies. ““I‘m very proud of our state-of-the-art biologics production facility - it’s truly exciting to play a part in Diamyd Medical’s growth and long-term success.” Sofia Mayans, Head of Manufacturing Site The employees at the Umeå facility are experts in e.g. cell culture and protein purification, paving the way for the development of future precision medicine treatments of Type 1 Diabetes.
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DIAMYD MEDICAL AB QUARTERLY REPORT 3 September 2024 – May 2025 9 Key figures for the Group 3 months Mar-May 2024/25 3 months Mar-May 2023/24 9 months Sep-May 2024/25 9 months Sep-May 2023/24 12 months Sep-Aug 2023/24 Research and development costs, MSEK -31.7 -27.3 -89.0 -62.0 -96.5 Liquid assets and short-term investments 319.3 162.4 319.3 162.4 132.4 Solidity, % 81 79 81 79 67 Result per share, before and after dilution, SEK -0.4 -0.4 -1.2 -1.1 -1.6 Liquidity and short-term investment per share, SEK 2.3 1.6 2.3 1.6 1.3 Equity per share, SEK 2.4 2.0 2.4 2.0 1.5 Total Cash flow per share, SEK 2.0 -0.2 2.0 0.0 0.0 Share price per closing, SEK 8.8 11.6 8.8 11.6 16.4 Number of shares per closing 137 499 723 99 722 978 137 499 723 99 722 978 99 722 978 Average numbers of shares 105 904 023 96 608 859 104 108 491 93 030 255 94 712 579 Average number of employees 32 25 30 25 25
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DIAMYD MEDICAL AB QUARTERLY REPORT 3 September 2024 – May 2025 10 Consolidated statement of comprehensive income KSEK Note 3 months Mar-May 2024/25 3 months Mar-May 2023/24 9 months Sep-May 2024/25 9 months Sep-May 2023/24 12 months Sep-Aug 2023/24 OPERATING INCOME Net income - 52 112 111 130 Other operating income 2 1 331 812 4 046 2 899 4 234 TOTAL OPERATING INCOME 1 331 864 4 157 3 011 4 364 OPERATING EXPENSES External research and development costs -31 679 -27 302 -89 028 -61 694 -96 484 External patent- and license costs -953 -945 -3 117 -2 881 -3 710 Personnel costs 3 -10 365 -7 947 -29 364 -23 283 -31 447 Other external costs 4 -4 528 -3 713 -13 070 -10 669 -13 340 Other operating expenses -264 -557 -1 552 -833 -1 077 Depreciation and impairment of tangible and intangible assets -1 661 -1 453 -4 749 -4 109 -10 991 Result of shares in participations - -1 258 - -3 555 6 119 TOTAL OPERATING EXPENSES -49 450 -43 175 -140 879 -107 293 -150 931 OPERATING RESULT -48 118 -42 311 -136 722 -104 283 -146 567 Profit/loss of sold shares or other securities 254 - 7 465 - 639 Impairment of participation in other companies -508 - -508 - -9 783 Interest income and similar profit items 5 319 2 237 8 554 4 256 6 001 Interest expense and similar loss items -828 - -3 702 -2 083 -2 140 RESULT BEFORE TAXES -43 882 -40 075 -124 913 -102 109 -151 850 Income tax - - - - - NET RESULT FOR THE PERIOD -43 882 -40 075 -124 913 -102 109 -151 850
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DIAMYD MEDICAL AB QUARTERLY REPORT 3 September 2024 – May 2025 11 Consolidated balance sheet KSEK Note 31 May 2025 31 May 2024 31 Aug 2024 ASSETS NON-CURRENT ASSETS Intangible assets Patents - - - Tangible assets 5 Land and buildings 29 342 35 222 29 291 Constructions in progress 883 192 413 Machinery and inventory 22 048 20 489 19 653 Financial assets 6 Deferred tax 215 1 443 297 Participation in associated companies 1 264 7 013 1 264 Participation in other companies 5 984 - 6 639 Other long-term receivables 155 398 338 TOTAL NON-CURRENT ASSETS 59 890 64 757 57 894 CURRENT ASSETS Trade receivables 41 37 23 Other receivables 6 780 3 299 2 705 Prepaid expenses and accrued income 14 095 17 719 24 050 Short term investments - 39 351 19 608 Liquid assets 319 262 123 032 112 758 TOTAL CURRENT ASSETS 340 179 183 439 159 144 TOTAL ASSETS 400 069 248 195 217 038 EQUITY AND LIABILITIES EQUITY Share capital 13 945 10 114 10 114 Statutory reserve 200 200 200 Share premium reserve non-restricted 885 035 586 356 586 349 Profit or loss brought forward -449 596 -299 116 -298 893 Net result for the period -124 913 -102 109 -151 850 TOTAL EQUITY 324 672 195 445 145 920 PROVISIONS Pensions and other obligations 192 495 420 TOTAL PROVISIONS 192 495 420 LONG TERM-LIABILITIES Other long-term liabilities 7 45 550 31 573 30 672 TOTAL LONG-TERM LIABILITIES 45 550 31 573 30 672 CURRENT LIABILITIES Trade payables 12 989 3 080 16 605 Other payables 8 404 10 568 8 921 Prepaid income and accrued expenses 8 262 7 034 14 499 TOTAL CURRENT LIABILITIES 29 655 20 683 40 025 TOTAL EQUITY AND LIABILITIES 400 069 248 195 217 038
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DIAMYD MEDICAL AB QUARTERLY REPORT 3 September 2024 – May 2025 12 Consolidated statement of cash flow SEK Note 3 months Mar-May 2024/25 3 months Mar-May 2023/24 9 months Sep-May 2024/25 9 months Sep-May 2023/24 12 months Sep-Aug 2023/24 OPERATING ACTIVITIES Operating profit/loss -48 118 -42 311 -136 722 -104 283 -146 567 Interest received 288 889 1 449 2 908 3 753 Interest paid - - - -8 -8 Non-cash flow items Depreciation 1 661 1 453 4 859 4 109 10 991 Other non-cash flow items 618 1 465 1 102 4 206 -5 259 CASH FLOW FROM OPERATING ACTIVITIES BEFORE -45 551 -38 504 -129 311 -93 067 -137 089 CHANGES IN WORKING CAPITAL Increase (-) decrease (+) receivables -1 533 1 591 5 861 -7 779 -13 502 Increase (+) decrease (-) payables 3 584 140 -10 288 829 21 411 NET CASH FLOW FROM OPERATING ACTIVITIES -43 500 -36 773 -133 739 -100 017 -129 181 INVESTING ACTIVITIES Investment in tangible assets -4 651 - 622 -7 864 - 7 437 -8 025 Investment in financial assets -608 - -608 - -1 000 Disposal of financial assets 1 008 - 1 008 - - Profit on disposal of financial assets - - 7 211 - 639 Matured short-term investments - - 19 608 - 19 744 Investment in short term investments - -39 351 - -39 351 -39 351 NET CASH FLOW FROM INVESTING ACTIVITIES -4 250 - 39 973 19 539 -46 788 -27 994 FINANCING ACTIVITIES New issue 267 375 57 300 315 392 135 208 135 208 Issue expense -10 982 -3 290 -12 874 -7 794 -7 731 Long-term liabilities 7 2 565 7 425 14 878 15 708 14 807 NET CASH FLOW FROM FINANCING ACTIVITIES 258 958 61 435 317 396 143 122 142 284 TOTAL CASH FLOW FOR THE PERIOD 211 207 -15 311 203 012 -3 684 -14 891 Cash and cash equivalents at beginning of period 103 750 137 148 112 758 127 533 127 533 Net foreign exchange difference 4 304 1 195 3 491 -818 116 CASH AND CASH EQUIVALENTS AT END OF PERIOD 319 262 123 032 319 262 123 032 112 758
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DIAMYD MEDICAL AB QUARTERLY REPORT 3 September 2024 – May 2025 13 Consolidated statement of changes in equity KSEK Share Capital Statutory Reserve Share premium reserve non restricted Other non- restricted equity Total Shareholders’ equity OPENING BALANCE SEPTEMBER 1, 2023 8 700 200 460 286 -299 789 169 397 Net result - - - -151 850 -151 850 New issue 1 414 - 133 794 - 135 208 Issue expenses - - -7 731 - - 7 731 Incentive program LTI 2022 - - - 896 896 CLOSING BALANCE AUGUST 31, 2024 10 114 200 586 349 -450 742 145 920 OPENING BALANCE SEPTEMBER 1, 2024 10 114 200 586 349 -450 742 145 920 Net result - - - -124 913 -124 913 New issue 3 831 - 311 561 - 315 392 Issue expenses - - -12 874 - -12 874 Incentive program LTI 2022 3 - - - 680 680 Incentive program LTI 2024 3 - - - 401 401 Incentive program Board LTI 2024 3 - - - 65 65 CLOSING BALANCE MAY 31, 2025 13 945 200 885 035 -574 509 324 672
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DIAMYD MEDICAL AB QUARTERLY REPORT 3 September 2024 – May 2025 14 Income statement for the parent company KSEK Note 3 months Mar-May 2024/25 3 months Mar-May 2023/24 9 months Sep-May 2024/25 9 months Sep-May 2023/24 12 months Sep-Aug 2023/24 OPERATING INCOME Net income 105 157 420 451 606 Other operating income 2 1 331 812 4 046 2 899 4 234 TOTAL OPERATING INCOME 1 436 968 4 466 3 350 4 840 OPERATING EXPENSES External research and development costs -31 679 -27 302 -89 028 -61 964 -96 484 External patent- and license costs - 953 -945 -3 117 -2 881 -3 710 Personnel costs 3 -10 365 -7 947 -29 364 -23 283 -31 447 Other external costs 4 -4 623 -4 204 -13 337 -12 199 -15 448 Other operating expenses -264 -557 -1 552 -833 -1 077 Depreciation and impairment of Tangible and intangible assets -1 149 -921 -3 147 -2 721 -3 657 TOTAL OPERATING EXPENSES -49 033 -41 876 -139 544 -103 882 -151 823 OPERATING RESULT -47 597 -40 907 -135 078 -100 532 -146 983 FINANCIAL INCOME AND EXPENSES Profit/loss of sold shares or other securities 254 - 7 465 - 639 Impairment of shares in subsidiaries - - - - -9 609 Impairment of participation in other companies -508 - -508 - -9 783 Interest income and similar profit items 5 510 2 462 9 156 4 915 6 885 Interest expense and similar loss items -828 - -3 702 -2 082 -2 140 TOTAL FINANCIAL INCOME AND EXPENSES 4 428 2 462 12 411 2 833 -14 008 RESULT BEFORE TAXES -43 169 -38 445 -122 667 -97 699 -160 991 Taxes - - - - - NET RESULT FOR THE PERIOD -43 169 -38 445 - 122 667 -97 699 -160 991
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DIAMYD MEDICAL AB QUARTERLY REPORT 3 September 2024 – May 2025 15 Balance sheet for the parent company KSEK Note 31 May 2025 31 May 2024 31 Aug 2024 ASSETS NON-CURRENT ASSETS Intangible assets Patents - - - Tangible assets Machinery and inventory 22 345 20 268 19 438 Financial assets Shares in subsidiaries 16 291 20 900 11 291 Long-term receivables from subsidiaries 15 000 18 000 18 000 Participation in associated companies 6 1 264 16 686 1 264 Participation in other companies 5 984 - 6 639 Other long-term receivables 155 398 338 TOTAL NON-CURRENT ASSETS 61 039 76 252 56 970 CURRENT ASSETS Trade receivables 41 36 - Receivables subsidiaries 618 1 425 1 655 Other receivables 6 509 3 094 2 587 Prepaid expenses and accrued income 14 072 17 690 24 021 Liquid assets and short-term investments 318 572 161 334 130 897 TOTAL CURRENT ASSETS 339 812 183 580 159 160 TOTAL ASSETS 400 850 259 832 216 130 EQUITY AND LIABILITIES EQUITY Restricted equity Share capital 13 945 10 114 10 114 Statutory reserve 200 200 200 Non restricted equity Share premium reserve non-restricted 885 035 586 356 586 349 Profits or loss brought forward -449 917 -290 295 -290 072 Net result for the period -122 667 -97 699 -160 991 TOTAL EQUITY 326 596 208 676 145 599 PROVISIONS Pensions and other obligations 192 495 420 TOTAL PROVISIONS 192 495 420 LONG TERM-LIABILITIES Other long-term liabilities 7 45 550 31 573 30 672 TOTAL LONG-TERM LIABILITIES 45 550 31 573 30 672 CURRENT LIABILITIES Trade payables 12 406 3 028 16 411 Other payables 8 044 8 976 8 521 Payables subsidiaries - 50 7 Prepaid income and accrued expenses 8 062 7 034 14 499 TOTAL CURRENT LIABILITIES 28 512 19 088 39 438 TOTAL EQUITY AND LIABILITIES 400 850 259 832 216 130
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DIAMYD MEDICAL AB QUARTERLY REPORT 3 September 2024 – May 2025 16 Notes Note 1 – General information and accounting principles This interim report includes the parent company Diamyd Medical AB (publ), Corp. Reg. No. 556242-3797 and the subsidiary Diamyd Biomanufacturing AB, Corp. Reg. No. 559041-0931. Unless otherwise stated, all amounts are in thousands of Swedish kronor (KSEK). Figures, if not otherwise stated, refer to the Group. Interim and annual reports are prepared with the application of the Annual Accounts Act and the Swedish Accounting Standards Board BFNAR 2012: 1 Annual Report and Consolidated accounts (K3). Note 2 – Other operating income Other operating income consists mainly of grants related to VINNOVA (Swedish innovation agency) financed projects. Note 3 – Long-term Incentive programs LTI 2022 The Company had as of May 31, 2025, allocated 28 participants rights to performance shares in accordance with LTI 2022. A total of 280 000 rights to performance shares have been allocated. LTI 2022 rights are measured on the allotment date at fair value of allocated equity instruments. As of May 31, 2025, social costs for LTI 2022 amounted to MSEK 0.0 and personnel costs MSEK 0.68 for the period. The personnel cost was based on the allocation value, simulated with the Monte Carlo method. LTI 2024 The Company had as of May 31, 2025, allocated 37 participants rights to performance shares in accordance with LTI 2024. A total of 370 000 rights to performance shares have been allocated. LTI 2024 rights are measured on the allotment date at fair value of allocated equity instruments. As of May 31, 2025, social costs for LTI 2024 amounted to MSEK 0.0 and personnel costs MSEK 0.40 for the period. The personnel cost was based on the allocation value, simulated with the Monte Carlo method. Board LTI 2024 The Company had as of May 31, 2025, allocated 6 participants rights to performance shares in accordance with Board LTI 2024. A total of 60 000 rights to performance shares have been allocated. Board LTI 2024 rights are measured on the allotment date at fair value of allocated equity instruments. As of May 31, 2025, social costs for Board LTI 2024 amounted to MSEK 0.0 and personnel costs MSEK 0.06 for the period. The personnel cost was based on the allocation value, simulated with the Monte Carlo method. Note 4 – Related-party transactions During the period companies represented by immediate family members of the main owner and Executive Chairman Anders Essen-Möller were contracted as consultants. Total compensation for consultancy services and salaries to immediate family members amounted to KSEK 1 741 (1 601). Anders Essen-Möller has through a company owned by Essen-Möller been compensated by KSEK 1 159 (694). Vice Chairman Erik Nerpin has through a company owned by Nerpin been compensated by KSEK 1 750 (-). The amount refers to advice in connection with new issues. Pricing has been set by the arm’s length principle. Group and parent company KSEK Sep-May 2024/25 Sep-May 2023/24 Sep-Aug 2023/24 Consultant fees and salary to related parties 1 741 1 601 2 156 Consultant fees to Board members 2 910 694 976
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DIAMYD MEDICAL AB QUARTERLY REPORT 3 September 2024 – May 2025 17 Note 5 – Tangible assets Group KSEK 31 May 2024/25 31 May 2023/24 31 Aug 2023/24 Land and buildings Opening acquisition value 39 836 32 199 32 199 Investments in existing property 1 219 6 996 6 812 Reclassifications 413 633 825 Closing acquisition value 41 468 39 828 39 836 Opening accumulated depreciation -10 545 -3 240 -3 240 Depreciation, period -1 581 - 1 366 -1 894 Impairment of property - - -5 411 Closing accumulated depreciation -12 126 -4 607 -10 545 Closing carrying amount 29 342 35 222 29 291 KSEK 31 May 2024/25 31 May 2023/24 31 Aug 2023/24 Constructions in progress Opening acquisition value 413 825 825 Purchases 883 - 413 Reclassifications -413 -633 -825 Closing carrying amount 883 192 413 KSEK 31 May 2024/25 31 May 2023/24 31 Aug 2023/24 Machinery and inventory Opening acquisition value 29 673 28 872 28 872 Purchases, machinery and inventory 5 763 694 800 Disposals machinery and inventory -308 - - Closing acquisition value 35 127 29 566 29 673 Opening accumulated depreciation -10 020 -6 334 -6 334 Depreciation, period -3 169 -2 743 -3 686 Disposals, period 110 - - Closing accumulated depreciation -13 079 -9 077 -10 020 Closing carrying amount 22 048 20 489 19 653
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DIAMYD MEDICAL AB QUARTERLY REPORT 3 September 2024 – May 2025 18 Note 6 – Financial assets Group The shares in NextCell Pharma AB have been reclassified from Participations in associated companies to Participation in other companies. Parent company Diamyd Medical AB owns shares in NextCell Pharma AB (corporate registration no 556965-8361) who develops stem cell therapies and operates a stem cell bank for private family saving of stem cells. At May 31, 2025, the carrying amount was approximately MSEK 6.6. Diamyd Medical’s share of the equity as well as share of the votes was as of the same date approximately 6.82 %. Diamyd Medical holds 25 % of the shares in the artificial intelligence company MainlyAI AB (corporate registration no 559258-7358). As of May 31, 2025, the carrying amount was MSEK 1.3. Note 7 – Long-term liabilities Group and parent company KSEK Sep-May 2024/25 Sep-May 2023/24 Sep-Aug 2023/24 Opening balance 30 672 15 865 15 865 Other long-term liabilities, Breakthrough T1D 14 878 15 708 14 807 Closing balance May 31, 2025 45 550 31 573 30 672 Diamyd Medical receives financing within its partnership with Breakthrough T1D (formerly JDRF), when certain milestones have been reached. If Diamyd Medical obtains commercial approval for Diamyd ® and sales of the drug are commercially successful, Breakthrough T1D will receive limited royalties. As a result of Diamyd Medical’s commitment pertaining to future royalties, payments from Breakthrough T1D are recognized as long-term liabilities.
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DIAMYD MEDICAL AB QUARTERLY REPORT 3 September 2024 – May 2025 19 Risks Diamyd Medical’s operations are associated with risks related to inter alia drug development, commercialization, financing, intellectual property, collaborations with partners, authority decisions, agreements and key personnel. For a description of the Company’s risks, please see the Annual Report for the fiscal year 20 24/2025. No significant changes in the Company’s risk assessment have occurred since the Annual Report was issued. Statement The Board of Directors and the CEO certify that the interim report gives a fair overview of the business, position and profit or loss of the Company and describes the principal risks and uncertainties that face the Company. This report has not been reviewed by the Company’s auditors. Stockholm, June 25, 2025 Anders Essen-Möller Erik Nerpin Chairman of the Board Vice Chairman of the Board Maria-Teresa Essen-Möller Torbjörn Bäckström Board member Board member Mark A. Atkinson Karin Hehenberger Board member Board member Ulf Hannelius Karin Rosén President & CEO Board member Financial Calendar Year-end Report October 8, 2025 Annual Report November 13, 2025 Annual General Meeting December 4, 2025 About Diamyd Medical Diamyd Medical develops precision medicine therapies to prevent and treat Type 1 Diabetes. 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 with potential for an accelerated approval pathway in the US 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 largescale 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.
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DIAMYD MEDICAL AB QUARTERLY REPORT 3 September 2024 – May 2025 20 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 June 25, 2025.