Diamyd Medical Ab Class B · OMXSTO:DMYD_B
Diamyd Medical Ab Class B — Investor Presentation (January 2025)
42 slides from Diamyd Medical Ab Class B's investor presentation, Jan 31, 2025
Slide 1: Diamyd for the Treatment of Autoimmune Diabetes
Diamyd® for the Treatment of Autoimmune Diabetes Stockholm NASDAQ First North Growth Market – 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: Diamyd: Revolutionizing Type 1 Diabetes Treatment with Antigen-Specific Immunotherapy
Diamyd®: Revolutionizing Type 1 Diabetes Treatment with Antigen- Specific Immunotherapy Diamyd® is an innovative antigen-specific immunotherapy targeting a large genetic subgroup of autoimmune diabetes (Type 1 Diabetes, LADA). Currently in pivotal Phase 3 for Stage 3 T1D at 60 clinics across Europe
Slide 4: Diamyd Medical company overview
DIAMYD MEDICAL • Swedish clinical phase pharmaceutical company, founded 1994 • NASDAQ First North Growth Market, ticker DMYD B FINANCES • Market Cap Jan 31, 2025~ MSEK 1,800 • Cash Nov 30, 2024: MSEK 152.9 (warrants of Series TO4 in March 2025 with a potential of MSEK 110) LEAD PRODUCT • Diamyd® - P
Slide 5: 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 6: Autoimmune Diabetes: Unmet need & economic burden
Autoimmune Diabetes: Unmet need & economic burden Type 1 Diabetes (T1D) ~ 500,000 new cases every year • More common in Western countries, especially Scandinavia • Life-long dependence on insulin therapy and blood glucose monitoring >$90 BN global annual economic burden* 100 80 billion USD $ 60 60 4
Slide 7: Accelerating interest for autoimmune diabetes from pharma & regulators
Accelerating interest for autoimmune diabetes from pharma & regulators $2.9 billion acquisition of Provention Bio by Sanofi. FDA-approved immunotherapy TZIELD Mar 2023 to delay onset of T1D. Sanofi leading concerted effort to raise T1D awareness and build the screening and treatment infrastructure f
Slide 8: Clinical Pipeline
Clinical Pipeline Diamyd® is the only disease-modifying therapy in the world for Type 1 Diabetes in Phase 3 development PROGRAM DEVELOPMENT STATUS Global Study / Indication Asset Preclinical Phase 1 Phase 2 Phase 3 Milestones Rights DIAGNODE-3 Fast track designation, Orphan designation, R&D partners
Slide 9: 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 LADA Mechanism o
Slide 10: Focus on preemptive medicine
Focus on preemptive medicine Diamyd® is designed to prevent diabetes complications and improve glucose control by stopping the autoimmune destruction of beta cells Reduced risk of1 ● Severe hypoglycemia Illustrative decline of functional beta ● Life-threatening ketoacidosis cell mass in autoimmune d
Slide 11: The antigen-specific immunotherapy Diamyd (rhGAD65 in alum)
The antigen-specific immunotherapy Diamyd® (rhGAD65 in alum) Identify responders with HLA DR3-DQ2 (40% of T1D in EUR + US) with routinely available testing 3 x simple monthly injections to stop the autoimmune destruction of beta cells Improve glucose control (HbA1c & Time in Range) and prevent diabe
Slide 12: Diamyd (rhGAD65/alum): Targeting the Root Cause of Autoimmune Diabetes
Diamyd® (rhGAD65/alum) Targeting the Root Cause of Autoimmune Diabetes Three convenient out-patient administrations only, renders long-term effect on beta cell preservation. Strong safety profile, no immunosuppression. Evaluated in around 1,000 persons with Stage 1, 2 & 3 Type 1 Diabetes as well as
Slide 13: Significant Momentum Paves Way for Potential Accelerated Approval
Significant Momentum Paves Way for Potential Accelerated Approval March 2022 February 2024 July 2024 Present Phase III starts Fast Track Stage 3 T1D Accelerated pathway Focus on expedited approval DIAGNODE-3 is initiated in FDA grants Fast Track designation for FDA acknowledges in Type C Potential f
Slide 14: Diamyd targets the GADA-first Type 1 Diabetes endotype with HLA DR3-DQ2 positivity
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 T1D No Response Auto-reactive T cell HLA DR3-DQ2 GAD absent HLA is central to
Slide 15: Acknowledged Precision Medicine approach
Acknowledged Precision Medicine approach Highlights • New medical consensus regarding genetically defined groups of T1D • Strong case for a precision medicine approach targeting likely responders • Diamyd Medical’s approach is to focus on individuals with GAD antibodies and HLA DR3-DQ2 (40% of US +
Slide 16: Very Good Safety and Tolerability Profile
Very Good Safety and Tolerability Profile No major safety signals in 1000 patients exposed to Diamyd®. Drop-out rate <1% across 15 clinical trials. Total patient exposure in 15 trials Diamyd® Placebo Summary of clinical safety data • Most common adverse events: transient tenderness at 513 990 inject
Slide 17: 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 18: 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 intralymphatic injections of Diamyd® given on top of standard of care Primary Endpoint • Change from Baseline to Month 15 in Mixed Meal Tolerance Test (MMTT) stimul
Slide 19: 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 20: 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 Glycaemic Better Time in Range, Time in Range % change from variabili
Slide 21: DIAGNODE-2 Phase 2b trial biomarker data support HLA-specific response
DIAGNODE-2 Phase 2b trial biomarker data support HLA-specific response GADA, proliferation and cytokine secretion Proliferation SI (mean change from baseline) 30 GADA (mean change from baseline, IU/ml) 60000 * 8 600 * (change from baseline, pg/mL) (change from baseline, pg/mL) 40000 * 400 * * * GAD-
Slide 22: 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 strengthens conclusion about patients carrying the HLA DR3-DQ2 gene being Diamyd® treatment responders and shows correlated treatment effects on C-peptide and HbA1c – the two co-primary end
Slide 23: Ultrasound-guided intralymphatic injection
Ultrasound-guided intralymphatic injection Quick, low-key outpatient procedure with discomfort comparable to venepuncture HCP feedback in DIAGNODE-2 Appointment Ultrasound Intralymphatic Treated patient (minutes) injection (seconds) • Procedure performed by a radiologist or trained professional • St
Slide 24: DIAGNODE-3 Pivotal Precision Medicine Phase 3 trial
DIAGNODE-3 Pivotal Precision Medicine Phase 3 trial Ongoing at approx. 50 clinical sites in Europe In partnership with Germany Czech Rep Estonia Spain Hungary Netherlands Sweden Poland Coordinating Investigator, DIAGNODE-3 Prof. Johnny Ludvigsson Ongoing at around a dozen clinical sites in the US Pr
Slide 25: DIAGNODE-3 Pivotal Precision Medicine Phase 3 Trial
DIAGNODE-3 Pivotal Precision Medicine Phase 3 Trial Multinational (EU + US), randomized, placebo-controlled, 2-arm trial assessing 3 intralymphatic injections of Diamyd® given on top of standard of care. Designed based on Phase 2b trial in alignment with FDA and EMA. Enrolling only likely responder
Slide 26: 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 T1D 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-Net discounts,
Slide 27: Added value compared to standard of care
POSITION DIAMYD® TO MAXIMIZE EFFICACY, SAFETY, CONVENIENCE Disease modifying therapies Added value compared to standard of care Immunosuppressive Antigen-specific treatments Cell therapies technologies Effect, Benefit Antigen-specific immunotherapy with Diamyd® Artificial targets the body’s immune s
Slide 28: Latent Autoimmune Diabetes in Adults (LADA)
Latent Autoimmune Diabetes in Adults (LADA)* *Also called Slowly progressing Autoimmune Diabetes (SAID) or Slowly progressing insulin- dependent diabetes mellitus (SPIDDM)
Slide 29: Background
Background In highly autoimmune LADA individuals: treatment that directly targets autoimmunity is needed *p< 0.007 Hals IK, Fiskvik Fleiner H, Reimers N, Astor MC, Filipsson K, Ma Z, Grill V, Björklund A. Investigating optimal β-cell-preserving treatment in latent autoimmune diabetes in adults: Resu
Slide 30: Glucagon-stimulated C-peptide levels unchanged in HLA-DR3DQ2 positive subgroup
Glucagon-stimulated C-peptide levels unchanged at 12 months vs Baseline (0 months) in the HLA-DR3DQ2 positive subgroup Phase 2 trial with Diamyd in up to 70 year-old LADA patients Glucagon-stimulated C-peptide * * 100 DR3DQ2 negative (n=7) Levels vs. Baseline (%) DR3DQ2 positive (n=7) 95 90 85 80 0
Slide 31: Conclusions
Conclusions • Treatment with intralymphatic GAD is well tolerated in LADA individuals – no safety concerns • GAD-induced immune responses appear compatible with those in studies with Type 1 Diabetes • Results on C-peptide suggest an HLA-dependent beneficial effect akin to Type 1 Diabetes Also see •
Slide 32: Type 1 Diabetes prevention (Stage 1 & 2)
Type 1 Diabetes prevention (Stage 1 & 2)
Slide 33: Diamyd Medical partners with DiaUnion to recruit participants
*) DIAMYD MEDICAL Press Release, November 7, 2023 Diamyd Medical partners with DiaUnion to recruit participants for Type 1 diabetes prevention trial Diamyd Medical has entered into a collaboration agreement with DiaUnion, a center of excellence in type 1 diabetes, to identify participants for the Di
Slide 34: Diamyd Medical Coordinates the ASSET Milieu
DIAMYD MEDICAL COORDINATES THE ASSET MILIEU A T1D Forum to drive precision medicine, prevention and screening Contact with T1D research community Aim for a European-level Partnerships in contact network developing AI algorithms Discuss best practices for Integration of data from screening programs d
Slide 35: About ASSET
ABOUT ASSET The innovation milieu ASSET (AI for Sustainable Prevention of Autoimmunity in the Society – www.asset.healthcare) will develop and evaluate new algorithms based on AI to be able to assess the individual risk of developing Type 1 Diabetes (T1D), and the likelihood of responding to differe
Slide 36: ASSET publication on using AI for T1D screening
ASSET publication on using AI for T1D screening published in Diabetologia and highlighted by EASD e-Learning
Slide 37: Manufacturing and Market Exclusivity of Diamyd
Manufacturing and Market Exclusivity of Diamyd®
Slide 38: Diamyd Medical is building a biomanufacturing plant for GMP commercial scale production
Diamyd Medical is building a biomanufacturing plant for GMP commercial scale production of rhGAD65 Commercial-scale production of rhGAD65 planned to be ready for BLA/MAA and market entry • 20,000 square feet facility in Umeå, Northern Sweden, comprising clean rooms, laboratory facilities and office
Slide 39: 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 40: Strong IP position
Strong IP position 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 administration of additiona
Slide 41: Multibillion Dollar Potential and Accelerated Approval Pathway
Multibillion Dollar Potential and Accelerated Approval Pathway Diamyd® offers a compelling vision, combining strong clinical progress, strategic regulatory advantages and several indications each with USD Multibillion potential Potential for Accelerated Approval in the US, with interim readout align
Slide 42: Diamyd Medical
Diamyd Medical www.diamyd.com
Diamyd Medical — Investor Presentation (January 2025) on 6ix