Diamyd Medical Ab Class B · OMXSTO:DMYD_B
Diamyd Medical Ab Class B — Investor Presentation (April 2025)
34 slides from Diamyd Medical Ab Class B's investor presentation, April 2025
Slide 1: Founded with the Mission to Cure Type 1 Diabetes
Founded with the Mission to Cure Type 1 Diabetes April 2025
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 to prevent and cure Type 1 Diabetes
Precision medicine to prevent and cure Type 1 Diabetes Precision medicine pipeline Significant commercial potential, Clinically validated and de-risked spanning prevention and strong regulatory alignment, immunology platform intervention near-term milestones • Antigen-specific • Clinical development
Slide 4: Addressing a significant unmet medical need and economic burden
Addressing a significant unmet medical need and economic burden >500 000 >$90 USD Life long new cases of Type 1 billion dependence on insulin treatment and blood Diabetes annually economic burden glucose measurements High risk 35 years 15 years for serious shorter health span shorter life span compl
Slide 5: Diamyd Medical addresses the full spectrum of insulin production
Type 1 Diabetes – Progressive and irreversible autoimmune destruction of insulin-producing cells Diamyd Medical addresses the full spectrum of Type 1 Diabetes Stage 0 Stage 1 Stage 2 Stage 3 Stage 4 Insulin production No symptoms No symptoms Symptoms Long-term Genetic risk Normal blood Abnormal Elev
Slide 6: Pipeline Overview
Pipeline Overview Targeting full spectrum of autoimmune diabetes through HLA-Specific antigen therapies Program Discovery Preclinical Phase 1 Phase 2 Phase 3 Status Stage 3 Type 1 Diabetes Ongoing in EU & US, (HLA DR3-DQ2 positive) DIAGNODE-3 early readout March Orphan designation; Fast 2026 Track d
Slide 7: Diamyd®
Diamyd® Recombinant GAD65 Formulated in Alum (rhGAD65/alum) Diamyd® Primary Indication (Fast Track and Orphan designation) Type 1 Diabetes (Stage 3) with residual beta cell function and HLA type DR3-DQ2 Label Expansion Type 1 Diabetes prevention (Stage 1 & 2), Fast Track designation Adult-onset Type
Slide 8: Diamyd® targets the GADA-first endotype with HLA DR3-DQ2
Diamyd® targets the GADA-first Type 1 Diabetes endotype with HLA DR3- DQ2 positivity Antigen-presenting cell Response HLA DR3-DQ2 Selected for Phase present 3 trial T cell receptor Diamyd® HLA presents GAD Individuals with Type 1 No Response Auto-reactive T cell Diabetes HLA DR3-DQ2 GAD absent HLA i
Slide 9: Regulatory and Commercial strategy
Regulatory and Commercial strategy
Slide 10: Pathway to market for Diamyd®
Pathway to market for Diamyd® Single pivotal Phase 3 trial (DIAGNODE-3) • Aligned with both FDA and EMA Fast Track designation • For the treatment of Stage 1, 2 & 3 Type 1 Diabetes with HLA DR3-DQ2 Orphan designation • For the treatment of Type 1 Diabetes with residual beta cell function Accelerated
Slide 11: Estimated > $2 Billion Peak Sales in the US Alone
Estimated > $2 Billion Peak Sales in the US Alone Diamyd® Launch indication • 60k+ patients (Stage 3 Type 1 Diabetes with residual beta cell function, HLA DR3-DQ2 positive, Age >= 12) US Pricing, formulary status & market share • WAC (gross) price $157K/course, grown at 2% p.a. • Limited Gross-to-Ne
Slide 12: Strong IP position and regulatory exclusivity
Strong IP position and regulatory exclusivity Core Intellectual Property • Substance of matter in the US until 2032 • Intralymphatic administration of Diamyd® in Europe, Japan, China, Hong Kong, Australia, South Africa, Eurasia and Canada, additional countries pending, expiry 2035. • Intralymphatic
Slide 13: Significant momentum paves way for potential Accelerated Approval
Significant momentum paves way for potential Accelerated Approval March 2022 July 2024 Present Phase 3 starts Accelerated pathway Focus on expedited approval DIAGNODE-3 is initiated in FDA acknowledges in Type C meeting Potential for accelerated approval. Blockbuster Europe and expands to the US in
Slide 14: Clinical Data supporting launch indication for Diamyd®
Clinical Data supporting launch indication for Diamyd®
Slide 15: Favorable safety and tolerability profile
Favorable safety and tolerability profile No major safety signals in >1,000 patients exposed to Diamyd®. Drop-out rate <1% in trials with targeted administration (intralymphatic, IL) of Diamyd®. Total patient exposure in 16 trials Summary of clinical safety data Diamyd® Placebo • Most common adverse
Slide 16: Meta-analysis of pre-2014 trials identified responder patients
Meta-analysis of 3 pre-2014 trials identified responder patients Meta-analysis of 3 randomized controlled clinical trials with subcutaneous Diamyd® conducted before 2014 with >500 individuals identified patients carrying HLA DR3-DQ2 gene as responders Mixed meal tolerance test (MMTT) stimulated C-pe
Slide 17: 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 Diamyd® given on top of standard of care Primary Endpoint • Change from Baseline to Month 15 in Mixed Meal Tolerance Test (MMTT) stimulated C
Slide 18: DIAGNODE-2 Phase 2b trial confirmed responder patients
DIAGNODE-2 Phase 2b trial confirmed responder patients Diamyd® achieved statistically significant preservation of C-peptide secretion, numerical improvement in HbA1c compared to placebo at Month 15 in patients with HLA DR3-DQ2 Mixed meal tolerance test (MMTT) stimulated C-peptide 56% reduction in C-
Slide 19: DIAGNODE-2 Phase 2b Trial confirmed responder patients
DIAGNODE-2 Phase 2b Trial confirmed responder patients In exploratory analyses, Diamyd® 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 variability • B
Slide 20: 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 baselin
Slide 21: Correlated Diamyd® treatment effects on C-peptide and HbA1c
Correlated Diamyd® treatment effects on C-peptide and HbA1c Updated meta-analysis including the Phase 2b trial shows correlated treatment effects on C-peptide and HbA1c – the two co-primary endpoints of the Phase 3 trial 3 or 4 doses of Diamyd® vs placebo 48% reduction in C- peptide decline, 4.8 Wit
Slide 22: Ultrasound-guided targeted injection
Ultrasound-guided targeted injection Quick, low-key outpatient procedure with discomfort comparable to venepuncture. Targets superficial lymphnode to enhance immunological response. Intralymphatic Appointment Ultrasound administration Treated patient (minutes) (seconds) • Procedure performed by a ra
Slide 23: The first ever precision medicine Phase 3 trial in Type 1 Diabetes
The first ever precision medicine Phase 3 trial in Type 1 Diabetes Diamyd® in individuals recently diagnosed with Stage 3 type 1-diabetes and positive for the HLA DR3-DQ2 haplotype Partner since 2023
Slide 24: DIAGNODE-3 Single Pivotal Precision Medicine Phase 3 trial
DIAGNODE-3 Single Pivotal Precision Medicine Phase 3 trial Aligned with the FDA and EMA. 60 clinics in the United States and Europe. Randomized, placebo-controlled, 2-arm trial to confirm the effect and safety of 3 targeted injections of Diamyd® given on top of standard of care. Co-Primary Endpoints
Slide 25: Supportive clinical data in Stage 1 & 2 Type 1 Diabetes & Adult-onset (LADA)
Supportive clinical data in Stage 1 & 2 Type 1 Diabetes & Adult-onset Type 1 Diabetes (LADA)
Slide 26: Phase 2 trial with Diamyd in LADA patients
Phase 2 trial with Diamyd in up to 70 year-old LADA patients 1-year pilot study of targeted injections of Diamyd® in individuals with adult-onset Type 1 Diabetes (latent autoimmune diabetes in adults (LADA)) . No safety concerns. Glucagon-stimulated C-peptide * * 100 DR3DQ2 negative (n=7) Unchanged
Slide 27: Clinical Data in Stage 1/ Stage 2 Type 1 Diabetes
Clinical Data in Stage 1/ Stage 2 Type 1 Diabetes Long-Term follow-up of DiAPREV-IT shows that two subcutaneous injections of Diamyd® may delay Type 1 Diabetes onset by nearly 7 years Analysis shows that 2 subcutaneous injections of Diamyd® may delay Type 1 Diabetes onset by nearly 7 years in childr
Slide 28: Diamyd Medical coordinates the asset milieu
DIAMYD MEDICAL COORDINATES THE ASSET MILIEU A Type 1 Diabetes Forum to drive precision medicine, prevention and screening Contact with Type 1 Diabetes research community Aim for a European-level Partnerships in contact network developing AI algorithms Discuss best practices for Integration of data f
Slide 29: Manufacturing of Diamyd®
Manufacturing of Diamyd® Wholly-owned biomanufacturing plant
Slide 30: Diamyd Medical has established a biomanufacturing plant for GMP
Diamyd Medical has established a biomanufacturing plant for GMP commercial scale production of recombinant GAD65 Commercial-scale production of rhGAD65 planned to be ready for BLA/MAA and market entry • 24,000 square feet facility in Umeå, Northern Sweden, comprising clean rooms, laboratory faciliti
Slide 31: Full Control and Predictability of the Manufacturing Process
Full Control and Predictability of the Manufacturing Process Diamyd Medical’s Umeå facility uses the Baculovirus Expression Vector System (BEVS) in the complex manufacturing process of recombinant human GAD65 protein Baculovirus Upstream expression system process & insect cells Drug Product formulat
Slide 32: Diamyd Medical
DIAMYD MEDICAL • Swedish clinical phase pharmaceutical company, founded in 1994 • NASDAQ First North Growth Market, ticker DMYD B FINANCES • Market Cap April 15, 2025 ~ MSEK 810 • Cash Apr 14, 2025: MSEK 93.0 • Preferential rights issue, MSEK 208, incl warrants TO5 exercisable in April 2026. Subscri
Slide 33: Management, Board of Directors, Scientific Advisory Board
Management Board of Directors Scientific Advisory Board Dr. Ulf Hannelius, PhD, MBA Professor Dr. Mark Atkinson, PhD SWE Anders Essen-Möller, MSc President & Chief Executive (Chair) Chairman, Founder Officer University of Florida Martina Widman, MSc Erik Nerpin, LL.M. Professor Dr. David Leslie, MB
Slide 34: Diamyd Medical
Diamyd Medical www.diamyd.com Ulf Hannelius, President & CEO ulf.hannelius@diamyd.com