Diamyd Medical AB Class B · OMXSTO:DMYD_B
Diamyd Medical AB Class B — Investor Presentation (August 2020)
31 slides from Diamyd Medical AB Class B's investor presentation, August 2020
Slide 1: Developing Therapies for Autoimmune Diabetes
Developing Therapies for Autoimmune Diabetes
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: Targeting Autoimmune and Insulin deficient Diabetes
Targeting Autoimmune and Insulin deficient Diabetes Leading clinical stage pipeline • First-in-class disease modifying therapies (Diamyd® and Remygen®) • Phase IIb development with upcoming pivotal program • Addressable market encompassing up to 25% of all diabetes patients De-risked development pro
Slide 4: Clinical stage disease modifying therapies
Clinical stage disease modifying therapies Inducing immunological tolerance to preserve endogenous insulin production. Stimulating regeneration of insulin producing beta cells and alleviating beta cell stress. The opportunity for Primary indication regeneration and market Approx. 25% of all > 1.5 mi
Slide 5: Prioritizing unmet medical need
Prioritizing unmet medical need 25% of the patients, autoimmune and severely insulin deficient diabetes, lack treatment options that address their underlying disease pathology Prioritized subgroups Autoimmune diabetes** Approximately 10% of all diabetes patients have severe autoimmune diabetes (SAID
Slide 6: Priority #1 - Autoimmune diabetes
Priority # 1 - Autoimmune diabetes Type 1 Diabetes LADA ~ 300,000 new cases every year* >1.2 million new cases every year** 132,000 children and adolescents (0-20 years of It is estimated that up to 10% of all type 2 age) and equally many adults are diagnosed with diabetes patients have autoimmune d
Slide 7: Annual economic burden of type 1 diabetes
Annual economic burden of type 1 diabetes* >30 billion USD in the US >90 billion USD globally → Disease modifying therapies for type 1 diabetes have a multibillion-dollar economic impact in the US alone *Modelling the total economic value of novel type 1 diabetes (T1D) therapeutic concepts, January
Slide 8: Leading pipeline in autoimmune diabetes
Leading pipeline in autoimmune diabetes Clinical Phase Product Indication Trial Participants Sponsor Status 0 I IIa IIb III Topline results Type 1 DIAGNODE-2 109 Diamyd Medical September 2020 diabetes, Diamyd® intervention Linköping DIAGNODE-1 12 Results available University LADA, NTNU, GADinLADA 15
Slide 9: Diamyd
Recombinant GAD65 Formulated in Alum Diamyd® (rhGAD65/alum) Primary Indication New-onset type 1 Diabetes Label expansion Type 1 Diabetes prevention, LADA Mechanism of Action Induce immunological tolerance against GAD65 Clinical Effect and Benefit Preserve the endogenous insulin production, reduce sh
Slide 10: Responders to Diamyd treatment identified
Responders to Diamyd® treatment identified → Publication supports significant clinical effect of the diabetes vaccine Diamyd® in genetically defined subgroup* → Aligned with the notion of Precision Medicine in type 1 diabetes** *Hannelius et al, Efficacy of GAD-alum immunotherapy associated with HLA
Slide 11: De-risked clinical development program for Diamyd
De-risked clinical development program for Diamyd® Supported by large safety database, identification of responders and enhanced efficacy with novel administration route 2013 – 2018 Pilot trials evaluating combinations and administration routes Subcutaneous program (2005 – 2012) Intralymphatic progr
Slide 12: Added value compared to standard of care
Position Diamyd® to maximize Efficacy, Safety and 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 immun
Slide 13: Intralymphatic administration route enhances effect of Diamyd
Intralymphatic administration route enhances effect of antigen-specific immunotherapy Diamyd® in type 1 diabetes 13
Slide 14: More efficient uptake in lymph nodes following intralymphatic administration
More efficient uptake in and drainage to lymph nodes following intralymphatic compared to subcutaneous administration Lessons Learned from Allergy Immunotherapy trials Subcutaneously (S.C.) injected large molecules including proteins do not effectively spread to the draining lymphnodes. Intranodal (
Slide 15: Simple outpatient procedure enhances value proposition for Diamyd
Simple outpatient procedure enhances value proposition for Diamyd® Potential to reach patients outside specialized clinics and avoiding costs related to hospitalization Intralymphatic Appointment Ultrasound Treated patient administration (minutes) (seconds) The procedure is performed by a radiologis
Slide 16: DIAGNODE-1 Phase IIa trial (results available)
DIAGNODE-1 Phase IIa trial (results available) Intralymphatic administration of Diamyd® in new-onset Type 1 Diabetes Treatment • 3 intralymphatic injections (outpatient procedure) of 4µg Diamyd® one month apart • Oral supplementation of Vitamin D Population • 12-24 old type 1 diabetes patients diagn
Slide 17: Clinical results support enhanced effect of intralymphatic Diamyd
Clinical results support enhanced effect of intralymhatic Diamyd® 12 patients followed for 30 months (main study). 3 patients followed for 42 months (follow-up study evaluating 4th booster injection) Preserved endogenous insulin production (C-peptide AUC) Partial remission (IDAAC≤9) 100 100 C-peptid
Slide 18: Clinical and immunological results support mechanistic rationale
Clinical and immunological results from Diamyd® trials support the mechanistic rational for antigen-specific reprogramming of the immune response 1. GAD65 is taken up, processed and presented by 3. T-cell deactivation APCs to T-cells by MHC Class II protein complexes. Immunological results from clin
Slide 19: DIAGNODE-2 Phase IIb trial
DIAGNODE-2 Phase IIb trial Intralymphatic administration of Diamyd® in new-onset Type 1 Diabetes Treatment • 3 intralymphatic injections (outpatient procedure) of 4µg Diamyd® one month apart • Oral supplementation of Vitamin D Population • 12-24 old type 1 diabetes patients diagnosed within the last
Slide 20: Diamyd market exclusivity and manufacturing
Diamyd® market exclusivity and manufacturing Core Intellectual Property • Substance of matter in the US until 2032 • Intralymphatic administration of Diamyd® in Europe, Japan, Australia and Russia, additional countries pending, expiry 2035. HLA subgroups and biomarkers in national phase with expiry
Slide 21: Vaccine Manufacturing in Umeå
Vaccine Manufacturing in Umeå 10,000 square foot site comprising clean rooms, laboratory facilities and office space taking over manufacturing of recombinant GAD65 (active pharmaceutical ingredient in the diabetes vaccine Diamyd®)
Slide 22: Remygen
Modified Release GABA Primary Indication Type 1 diabetes Remygen® Label expansion LADA, Insulin-deficient type 2 diabetes Mechanism of Action Activate GABA-receptors in the pancreas Clinical Effect • Regenerate endogenous insulin production, reduce short- and long-term complications • Prevention of
Slide 23: Clinical results with attractive path to market for Remygen
Clinical results with attractive path to market for Remygen® ▪ Ongoing clinical Phase IIa trial*: ▪ ReGenerate-1 at the University of Uppsala where Remygen® (proprietary formulation of GABA) alone and in combination with low-dose alprazolam (GABA receptor modulator to enhance effect, see next slide)
Slide 24: Positive allosteric modulators enhance GABA's beta cell regenerative effects
Positive allosteric Effect of PAMs on INS-1 cell proliferation. INS-1 cells were cultured with the indicated PAM at a dose range of 10 −9 to 10−6 M and assessed for their proliferation. Data shown are the average rate of proliferation relative to that of cultures with media alone (designated as 1).
Slide 25: Remygen market exclusivity and manufacturing
Remygen® market exclusivity and manufacturing Core Intellectual Property • Exclusive license from UCLA on treating diabetes and other inflammatory diseases with GABA • Formulation patent application (Remygen®). Application in national phase. • Exclusive license from UCLA on GABA in combination with
Slide 26: Board, Management and Scientific Advisors
Board, Management and Scientific Advisors 26
Slide 27: Board of Directors
Board of Directors Erik Nerpin Anders Essen-Möller Maria-Teresa Essen-Möller Torbjörn Bäckström Mark A. Atkinson Independent of the Company Founder of and CEO during CEO of Health Solutions AB. CEO of Umecrine AB. Professor of Diabetes Research, and its principal owners. 1996-2007 of Diamyd Medical
Slide 28: Management
Management Ulf Hannelius Martina Widman Anna Styrud Anton Lindqvist Chief Executive Officer Director Clinical Development Chief Financial Officer Chief Scientific Officer PhD in Molecular Biology from M.Sc. in Mechanical Engineering B.Sc. in Business M.Sc in Molecular Karolinska Institutet in from t
Slide 29: Top Worldwide Experts
Top Worldwide Experts Covering the areas of clinical practice and scientific excellence in Type 1 Diabetes and LADA Prof. Johnny Ludvigsson Prof. David Leslie Prof. Åke Lernmark Prof. Daniel Kaufman Prof. Mark A. Atkinson Professor of Pediatrics. First Professor of Diabetes and Professor in Experime
Slide 30: Diamyd Medical
DIAMYD MEDICAL • Swedish clinical phase pharmaceutical company, founded 1994 • NASDAQ First North Growth Market, ticker DMYD B FINANCES • Market Cap Aug 10, 2020 ~ MSEK 2 075 • Burn rate / month ~ MSEK 3.0 • Cash May 31, 2020: MSEK 81.5 INDICATIONS • Diabetes • Autoimmunity PRODUCT CANDIDATES • Diam
Slide 31: Diamyd Medical
Diamyd Medical www.diamyd.com