Diamyd Medical Ab Class B · OMXSTO:DMYD_B
Diamyd Medical Ab Class B — Investor Presentation (January 2026)
36 slides from Diamyd Medical Ab Class B's investor presentation, January 2026
Slide 1: With the mission to cure type 1 diabetes
With the mission to cure type 1 diabetes NASDAQ First North Growth Market, ticker: DMYD B
Slide 2: Disclaimer
Disclaimer This Presentation (”Presentation”) has been prepared by Diamyd Medical AB (“Diamyd” or “the Company”). By accepting this Presentation, the recipient acknowledges and agree to the following: The information contained herein have been prepared to assist interested parties making their own e
Slide 3: Precision medicine for type 1 diabetes
Precision medicine for type 1 diabetes Therapeutic preservation of pancreatic function for early reversal and treatment Validated, de-risked immunology platform Precision medicine - reversal and intervention • Antigen-specific immunotherapy targeting genetic subgroups • Clinical development program,
Slide 4: Significant unmet medical need and economic burden
Significant unmet medical need and economic burden 35 years >500 000 >$90 billion shorter health span new cases of type 1 diabetes annually economic burden Life long 15 years High risk dependence on insulin treatment for serious complications incl. and blood glucose measurements shorter life span ca
Slide 5: Type 1 Diabetes stages
Type 1 Diabetes Asymptomatic autoimmunity, incipient deficiencies in blood glucose monitoring and clinical diagnosis requiring lifelong insulin therapy Diamyd Medical addresses the full spectrum of type 1 diabetes Genetic risk1) Stage 1 Stage 2 Stage 3 Long-term T1D2) Genetic risk Autoimmunity Autoi
Slide 6: Preserving pancreatic function
Preserving pancreatic function Addressing the autoimmune destruction of insulin producing cells • Therapeutic targeting of the autoimmune destruction of insulin-producing beta cells Insulin- in the pancreas. producing beta cells • Preserving pancreatic function Proinsulin (endogenous insulin/C-pepti
Slide 7: Pipeline overview
Pipeline overview Targeted treatment across all stages of type 1 diabetes through HLA-specific antigen therapies Program Discovery Preclinical Phase 1 Phase 2 Phase 3 Status Type 1 diabetes, Stage 3 Ongoing in the EU and US, (HLA DR3-DQ2 positive) Orphan early readout expected Drug Designation; arou
Slide 8: Retogatein - Recombinant Glutamic Acid Decarboxylase (GAD) formulated in Alum
Retogatein - Recombinant Glutamic Acid Decarboxylase (GAD) formulated in Alum (rhGAD65/alum) Therapeutic preservation of pancreatic function for early reversal and treatment Primary Indication Clinical Effect and Benefit • Type 1 diabetes (Stage 3) with residual beta cell • Preserve function of the
Slide 9: Genetically validated precision medicine approach
Genetically validated precision medicine approach Retogatein (rhGAD65) targets the GADA-first type 1 diabetes endotype with HLA DR3-DQ2 positivity representing approximately 40% of of those living with type 1 diabetes Antigen-presenting cell T cell receptor HLA presents GAD Newly diagnosed HLA DR3-D
Slide 10: Genetically validated precision medicine approach
Genetically validated precision medicine approach Retogatein (rhGAD65) targets the GADA-first type 1 diabetes endotype with HLA DR3-DQ2 positivity Retogatein (rhGAD65) responders* Age of auto-antibody occurrence GADA-first disease IAA-first disease • HLA DR3-DQ2 (40%) • HLA DR4-DQ8 (60%) • Adenoviru
Slide 11: Regulatory & Commercial strategy
Regulatory & Commercial strategy
Slide 12: Pathway to market for retogatein (rhGAD65)
Pathway to market for retogatein (rhGAD65) Therapeutic preservation of pancreatic function for early reversal and treatment Single pivotal Phase 3 trial (DIAGNODE-3) Fast Track Designation • Aligned with both FDA and EMA • Fast Track Designation from the U.S. FDA for the treatment of Stage 1, 2 & 3
Slide 13: Estimated > $2 billion peak sales in the US alone
Estimated > $2 billion peak sales in the US alone Retogatein (rhGAD65) launch indication Significant Upsides • 60k+ patients (Stage 3 Type 1 Diabetes with • Ex-US sales residual beta cell function, HLA DR3-DQ2 • Life Cycle Management – Stage 1, 2 type 1 positive, age >= 12) diabetes, adult-onset typ
Slide 14: Strong IP position and regulatory exclusivity
Strong IP position and regulatory exclusivity Core Intellectual Property Regulatory exclusivity • Composition of matter in the US until 2032 • US BLA approval provides 12 years exclusivity • Intralymphatic administration of retogatein from market approval (rhGAD65) in Europe, Japan, China, Hong Kong
Slide 15: Competitive positioning
Competitive positioning Based on late-stage development, unique modality and favorable safety profile Phase 1 Phase 2 Phase 3 Market High specificity The illustration shows 3 Insulin-based antigens 1 2 retogatein 3 retogatein (rhGAD65) (rhGAD65) examples of mainly 3 Antigen combinations company-driv
Slide 16: Life-cycle management opportunities
Life-cycle management opportunities Retogatein offers unique opportunities to drive innovation, expand reach and maximize impact throughout the product life cycle Potential for regular boosters Label expansion • Dose-response demonstrated • Studies across Stage 1 & Stage 2 type 1 diabetes, • Booster
Slide 17: Clinical Data
Clinical Data Supporting launch indication retogatein (rhGAD65)
Slide 18: First in class, best in class and disease modifying
First in class, best in class and disease modifying Clinical summary of retogatein (rhGAD65) in Stage 3 type 1 diabetes Discovery Confirmation • Meta-analysis of clinical trials in the subcutaneous • DIAGNODE-3 is a pivotal trial to confirm benefit of program leads to identification of responder ret
Slide 19: Favorable safety and tolerability profile
Favorable safety and tolerability profile Retogatein (rhGAD65) in Stage 3 type 1 diabetes Summary of clinical Total patient exposure Patient drop-out rate safety data in 16 trials1 in clinical trials • No new or unexpected safety 15% signals noted 12% • No suspected unexpected serious adverse reacti
Slide 20: Meta-analysis of genetic responder group
Meta-analysis of genetic responder group Meta-analysis of 3 randomized controlled clinical trials with subcutaneous retogatein (rhGAD65) conducted before 2014 with >500 individuals identified patients carrying HLA DR3-DQ2 gene as responders Mixed meal tolerance test (MMTT) stimulated C-peptide 44% r
Slide 21: DIAGNODE-2 Phase 2b trial confirmed responder patients
DIAGNODE-2 Phase 2b trial confirmed responder patients European, multinational, randomized, placebo-controlled, 2-arm trial assessing 3 targeted injections of retogatein (rhGAD65) given on top of standard of care Primary Endpoint • Change from Baseline to Month 15 in Mixed Meal Tolerance Test (MMTT)
Slide 22: DIAGNODE-2 Phase 2b trial confirmed responder patients
DIAGNODE-2 Phase 2b trial confirmed responder patients Retogatein (rhGAD65) achieved statistically significant 56% preservation of C-peptide secretion, numerical favours Placebo favours Retogatein improvement in HbA1c compared to placebo at Month 15 in patients with HLA DR3-DQ2. favours Retogatein f
Slide 23: DIAGNODE-2 Phase 2b trial confirmed responder patients
DIAGNODE-2 Phase 2b trial confirmed responder patients In exploratory analyses, retogatein (rhGAD65) achieved statistically significant benefit on Continuous Glucose Monitoring (CGM) outcomes in patients carrying the HLA DR3-DQ2 responder gene Time in Range Time in severe Glycaemic hyperglycaemia va
Slide 24: DIAGNODE-2 Phase 2b trial biomarker data support HLA-specific response
DIAGNODE-2 Phase 2b trial biomarker data support HLA-specific response GAD-specific immune response differentiates responders from non-responders Proliferation SI (mean change from baseline) 30 GADA (mean change from baseline, IU/ml) 60000 * 8 600 * * (change from baseline, pg/mL) (change from basel
Slide 25: Ultrasound-guided targeted injection
Ultrasound-guided targeted injection Quick, low-key outpatient procedure with discomfort comparable to venepuncture. Targets superficial lymph node to enhance immunological response Appointment Ultrasound Intralymphatic Treated (minutes) administration patient (seconds) • Procedure performed by a ra
Slide 26: The first ever precision medicine Phase 3 trial in type 1 diabetes
The first ever precision medicine Phase 3 trial in type 1 diabetes Retogatein (rhGAD65) in individuals recently diagnosed with Stage 3 type 1 diabetes and positive for the HLA DR3-DQ2 haplotype Partner since 2023
Slide 27: DIAGNODE-3 single pivotal precision medicine Phase 3 trial
DIAGNODE-3 single pivotal precision medicine Phase 3 trial Randomized, placebo-controlled, 2-arm trial to confirm the effect and safety of 3 targeted injections of retogatein (rhGAD65) given on top of standard of care. Design aligned with the FDA and EMA. 57 clinics in the United States and Europe.
Slide 28: Significant momentum and near-term clinical and regulatory catalysts
Significant momentum and near-term clinical and regulatory catalysts March 2022 July 2024 March 2026 Q1 2028 Phase 3 starts Accelerated pathway Interim efficacy readout Long-term durability DIAGNODE-3 is initiated in Europe and FDA acknowledges in Type C meeting C-peptide ~170 patients, 15 months. P
Slide 29: Supportive Clinical Data
Supportive Clinical Data Stage 1 & 2 type 1 diabetes and adult-onset type 1 diabetes (LADA)
Slide 30: Phase 2 trial with retogatein in up to 70-year-old LADA patients
Phase 2 trial with retogatein in up to 70-year-old LADA patients 1-year pilot study of targeted injections of retogatein (rhGAD65) in individuals with adult-onset Type 1 Diabetes (latent autoimmune diabetes in adults (LADA)). No safety concerns. . Glucagon-stimulated C-peptide * * 100 DR3DQ2 negativ
Slide 31: Clinical data in Stage 1 and Stage 2 Type 1 Diabetes
Clinical data in Stage 1 and Stage 2 Type 1 Diabetes Long-Term follow-up of DiAPREV-IT shows that two subcutaneous injections of retogatein (rhGAD65) may delay Type 1 Diabetes onset by nearly 7 years DiAPREV-IT: 2 subcutaneous injections of . retogatein (rhGAD65) in 50 children positive for two or m
Slide 32: Manufacturing of retogatein (rhGAD65)
Manufacturing of retogatein (rhGAD65) Wholly-owned biomanufacturing plant
Slide 33: Biomanufacturing facility - retogatein (rhGAD65)
Biomanufacturing facility - retogatein (rhGAD65) Commercial-scale production Umeå, Sweden • 24,000 square feet facility, comprising clean rooms, laboratory facilities and office space • Commercial-scale production of retogatein (rhGAD65) to be ready for BLA/MAA and market entry • GMP certification o
Slide 34: Manufacturing process
Manufacturing process Diamyd Medical’s biomanufacturing facility in Umeå uses the Baculovirus Expression Vector System (BEVS) in the complex manufacturing process of recombinant human GAD65 protein • Baculovirus expression system • Clarification • rhGAD65/alum • Insect cells • Capture • Formulated e
Slide 35: Management, Board of Directors, Scientific Advisory Board
Management Board of Directors Scientific Advisory Board Dr. Ulf Hannelius, PhD, MBA Anders Essen-Möller, MSc Professor Dr. Mark Atkinson, PhD (Chair) President & Chief Executive Officer Chairman, Founder University of Florida Erik Nerpin, LL.M. Professor Dr. David Leslie, MB Martina Widman, MSc Vice
Slide 36: There's no insulin like your own
There’s no insulin like your own www.diamyd.com
Diamyd Medical — Investor Presentation (January 2026) on 6ix