Diamyd Medical AB Class B · OMXSTO:DMYD_B
Diamyd Medical AB Class B — Shareholder Meeting (March 2008)
23 slides from Diamyd Medical AB Class B's shareholder meeting presentation, Mar 10, 2008
Slide 1: Extra General Shareholders meeting, March 10, 2008
”In the treatment of Diabetes and Diabetes related complications” Extra General Shareholders meeting March 10, 2008
Slide 2: Agenda
Agenda X 1. Opening of the meeting X 2. Election of the Chairman Extra General Shareholder´s Meeting X 3. Drawing up and approval of the voting list X 4. Approval of the Agenda X 5. Election of secretary and two persons to attest the minutes X 6. Decision on proper notice of Extra General Meeting X
Slide 3: About Diamyd Medical
About Diamyd Medical X BioPharmaceutical company listed on NGM 1997 X Listed on OMX since 2002 (NOMX ticker: DIAM B) X US ADR Level 1 since 2006 (ticker: DMYDY) X Offices in Stockholm, Sweden & Pittsburgh, PA, USA Autoimmune diabetes & Diabetes related complications Diamyd® & NTDDS -3-
Slide 4: Diamyd®
Diamyd® X GAD is a major antigen in the autoimmune attack against pancreatic beta cells that results in insulin dependent diabetes, also called autoimmune diabetes X Diamyd Medical has an exclusively licensed patent portfolio which protects the therapeutic use of recombinant GAD -4-
Slide 5: Treatment with Diamyd®
Treatment with Diamyd® X Small dose – 20 µg in 0.5 mL subcutaneous injection X Two simple injections (day 1 and day 30) X Significant effect for more than 30 months X Clean safety profile X Easy to administer, no hospitalization X High acceptance among parents and patients -5-
Slide 6: Diamyd® Clinical Trials to Date
Diamyd® Clinical Trials to Date X No treatment related Serious Adverse Events in any Diamyd® study! X 149 patients treated with Diamyd® in total, of which 35 children X Up to 5 yrs of follow-up -6-
Slide 7: Diamyd® Efficacy in Type 1 Diabetes
Diamyd® Efficacy in Type 1 Diabetes X Left: Patients with diabetes type 1 for less than 18 months X Right: Patients with diabetes type 1 for less than 3 months Change in C-peptide (AUC) MMTT, Means ± SEM 0 -0,1 -0,2 -0,3 hour pmol/ml/2 hour p=0.02 -0,4 pmol/ml/2 -0,5 p=0.01 -0,6 -0,7 Diamyd n=35 -0,
Slide 8: Received email (Swedish)
Received email (Swedish) X Idag: X Skiter jag i svenska "Jante" X Ger jag tusan i att man inte ska "ropa hej förrän man är över bäcken" X Bryr jag mig inte om att "man ska inte vara för glad för då..." X X Idag: X Har jag facit på hand X Vet jag att det ÄR alldeles på riktigt och sant X att vår älsk
Slide 9: Worldwide recognition of Diamyd®
Worldwide recognition of Diamyd® X Press Release, Stockholm, Sweden, November 22, 2007 “Diamyd Medical announced today that it has executed a Clinical Trial Agreement with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) for a planned clinical study with the Diamyd® GAD-a
Slide 10: Current Status and Near-term Plans
Current Status and Near-term Plans Start phase III trials during spring 2008 2 x 300 early onset T1D patients 0-3 months since diagnosis 15 month study period and 15 month follow-up ; US IND for phase III trials with Diamyd® filed in December 2007 – Principal Investigator: Professor Jerry Pa
Slide 11: Diamyd® Applications
Diamyd® Applications X Recent onset type 1 diabetes X Preventive treatment of subjects with risk for developing type 1 diabetes X Type 2-LADA X Combination therapies with beta cell regeneration agents, e.g. GLP-1 X Use in beta cell transplantation X Stem cell therapy - 11 -
Slide 12: Nerve Targeting Drug Delivery System (NTDDS)
Nerve Targeting Drug Delivery System (NTDDS) New Class of Nerve Therapies HSV Gene Delivery new class of nervous system disease therapies X Liability Disclosure Statement ¾ Intradermal delivery Vector taken up by neuron ¾ Therapeutic agent released into the synapse of the 1st order neuron and spinal
Slide 13: NP2 – NTDDS+Enkephalin for Treatment of Chronic Pain
NP2 – NTDDS+Enkephalin for Treatment of Chronic Pain Preproenkephalin (PPE) is processed to form leu- and met- enkephalin opioid peptides. Binding to neuronal opioid receptors blunts pain signal generation. Enkephalin peptides also have anti-inflammatory effects by acting on opioid receptors express
Slide 14: HSV Enkephalin Reduces Acute Pain
Acute / Inflammatory Pain - Formalin Footpad Test HSV Enkephalin Reduces Acute Pain 3.0 2.5 Weighted Pain Score 2.0 SHZ- Control 1.5 SHPE- HSV Enkephalin 1.0 0.5 Vector 0 SHZ 0 10 20 30 40 50 60 70 80 Minutes after formalin injection - 14 -
Slide 15: NP2 – Phase 1 Safety Trial – Cancer Pain
NP2 – Phase 1 Safety Trial – Cancer Pain • Phase 1 Clinical study Q2 2008 • Dose escalation trial with 12 patients in three dose cohorts • IND approved February 2008 Liability Disclosure Statement • University of Michigan – Principal Investigator David Fink, MD • Localized pain from cancer. Pain rat
Slide 16: Product Pipeline
Product Pipeline Validated Research Preclinical Phase I Phase II Phase III Project Product Lead Indication Target AUTOIMMUNE DIABETES Diamyd® GAD65 Type 1 New Onset Diamyd® GAD65 Type 2 - LADA NEUROLOGY NP2 Enkephalin Cancer Pain NG2 GAD SCI Diabetes Pain Neuropathic pain Shingles Neurologix Inc Par
Slide 17: Proposal
Proposal X The Board of Directors proposal for authorization on one or several occasions before the next Annual Shareholders' Meeting, with or without consideration of the preferential shareholder rights to issue 91,000 shares of series B and warrants which will give the right to subscribe for 991,0
Slide 18: Proposal cont.
Proposal cont. X The authorization is proposed to be valid for acquiring whole or parts of companies, assets, and cash or for settlements or other conditions as stated in chapter 2 §5 second paragraph 1-3 and 5 in the Companies Act. - 18 -
Slide 19: Proposal cont.
Proposal cont. X After full execution of the authorization of issuing shares in combination with the authorization given at the Annual Shareholders' Meeting, the dilution is calculated to 10 percent of the share capital, based on the total number of shares. X After full execution of the authorizatio
Slide 20: Diamyd Investment History & Future
Diamyd Investment History & Future Listing on the Stockholm OMX (O- list) Diamyd NDA Positive 6 months Phase IIa submission results Strong Phase IIb in T1D Outlicensed GAD65 to Diamyd® Phase III Neurologix for Trials Positive Phase I study; Parkinson’s NTDDS Phase I Rights Issue US$ 4M Funding US$10
Slide 21: Potential Roadmap – Current View
Potential Roadmap – Current View Diamyd® Diamyd® Diamyd® •Phase III studies in US and EU •Phase III - last patient in •Results Phase III trials •TrialNet intervention trial •TrialNet intervention trial - last patient in •Filing for market approval •5 year data from Phase IIa LADA trial •Add more ind
Slide 22: Investment Strategy
Investment Strategy Selling 10% of shares plus additionally 10% in options will give Diamyd a possibility to X Run full speed with Phase III studies X Continue partnership discussions as a Phase III company - 22 -
Slide 23: Disclaimer
Disclaimer Neither the Depositary nor the Company nor any of their respective directors, supervisory or management board members, employees, agents or affiliates shall incur any liability to any Owner or Beneficial Owner of any Receipt, (i) if by reason of any provision of any present or future law