Diamedica Therapeutics Inc. · NASDAQ:DMAC
Diamedica Therapeutics — Corporate Update (June 2019)
25 slides from Diamedica Therapeutics's corporate update, Jun 19, 2019
Slide 1: DM199 CKD Phase Ib Interim Results and Phase II Overview
WY DiaMedica DM199 CKD Phase Ib “IS THERAPEUTICS Interim Results and Phase II Nasdaq: DMAC Overview June 2019
Slide 2: Forward Looking Statement
FORWARD LOOKING STATEMENT This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, which reflect the Company's current expectation regarding future events. The words “estimate”, “believe’, “anticipate’, “intend”, “expect’,
Slide 3: Agenda
w " AGENDA Introductory Remarks Phase 1b Interim Results Rationale for DM199 in CKD Overview of Phase II Trial Closing Remarks DiaMedica
Slide 4: Potential Therapeutic Benefits of DM199: Protein Replacement Therapy
POTENTIAL THERAPEUTIC BENEFITS OF DM199: PROTEIN REPLACEMENT THERAPY Promoting homeostasis: improving blood flow and reducing inflammation throughout the body DM199 (rKLK1) SSS 1 ' 1 ' 1 ‘| ' 1 | renal function iv ¥ + 1 vasodilation 7 vasodilation visual acuity control ‘1 glucose tolerance ‘} tenal
Slide 5: Chronic Kidney Disease (CKD)
CHRONIC KIDNEY DISEASE (CKD) SIGNIFICANT UNMET NEED + The progressive loss of kidney function leading to dialysis, transplantation and ultimately death = Current standard of care ~ managing blood pressure > ACEi (ie. Ramipril) and ARB (ie. Valsartan, Losartan) * Less than 30% patients on required do
Slide 6: Growing Body of DM199/KLK1 Clinical Evidence
GROWING BODY OF DM199/KLK1 CLINICAL EVIDENCE KLK1 Endogenous Protein Crude Forms of KLK1 Used in Asia + Naturally produced in the bods Millions of patients treated in Japan and China + KLK1 believed to p for kidney diseases and related disorders with KLK1 derived from porcine (pig) pancreas and huma
Slide 7: CKD Phase Ib Interim Results
DM199: CKD phase lb interim results : The Company expects to publish full results in peer reviewed journal and/or upcoming conference presentation 7 9% DiaMedica
Slide 8: CKD Phase Ib Trial Design
DM199 CKD PHASE Ib TRIAL DESIGN Key objectives of Phase 1b: Evaluate the safety, tolerability, PK and PD of DM19 Multi-Center US, Randomized, multi Dose D participants (Cohort 1N=24, Cohort 2 N=8) Endpoint v | Phase Ib to >< SE eee ep oo Day Day 1 Primary and secondary endpoints over 11 days: Safety
Slide 9: CKD Phase Ib Safety and Tolerability
DM199 CKD PHASE Ib SAFETY AND TOLERABILITY RESULTS SUPPORT ADVANCING TO PHASE II Safety & tolerability profile consistent with prior studies Safety and tolerability: M199 was safe and well-tolerated with no drug related SAE’s No discontinuations due to treatment related AEs AE reported were very typ
Slide 10: CKD Phase Ib PK Supports Infrequent Dosing
DM199: CKD PHASE Ib PK SUPPORT INFREQUENT DOSING Identified dose level and frequency for Phase II CKD studies Pharmacokinetic (PK) data at + Serum half-life supports dosing 2x per week without change to formulation + Opportunity for future long-acting formulation to further reduce dosing frequency 7
Slide 11: DM199 CKD Phase 1b PK in Moderate & Severe Participants
Mos DM199 CKD PHASE 1B PK IN MODERATE & SEVERE PARTICIPANTS Similar PK profile between severe and moderate participants \derate & severe CKD patients similar PK fil profile No dosing adjustments needed based on kidney function Do not anticipate full renal study will be be required based on results P
Slide 12: CKD Phase 1b Overall Trend Analysis for NO, PGE, and UACR
DM199 CKD PHASE 1B OVERALL TREND ANALYSIS FOR NO, PGE, AND UACR Observed trends in NO, PGE, and UACR with peak values at 24 hours Trends correspond with greatest eGFR improvement PGE, (N=27) UACR (N=16)? 45.0% 7 o% a HRS 24 HRS 72 HRS 40.0% aad i) 9%) 35.0% ro) n1% 30.0% (om Ga) 2 g 2 25.0% 2 1%) 2
Slide 13: DM199 CKD Phase 1b Overall eGFR Data — Early Signal
‘GFR Change (mL/Min/1.73*) DM199 CKD PHASE 1B OVERALL eGFR DATA — EARLY SIGNAL Estimated glomerular filtration rate (eGFR) ~ measure of kidney function 6 HRS 24 HRS Time After Dosing © Mean ‘A Median 72 HRS Time After Dosing 24 Hours 72 Hours * P=<0.05, ttest ** P=<0.01, ttest % of Patients With An
Slide 14: DM199 CKD Phase 1b PD and Biomarkers by Dose Levels
Umol/L Suglkg, DM199 CKD PHASE 1b PD AND BIOMARKERS BY DOSE LEVELS FOR NO, PGE,, eGFR AND UACR NO Sug/ke mi/min/1.73? 888 8B DM199 by dose @ 3, 5 and 8 g/kg T Buglke du " Hi baseline | ] | | * P=<0.05, t-test 3 ug/kg 1,400 PGE, 1,200 ; i I \ ° | | 3 ug/ke Sug/ke 8 ug/ke e/ml 888 83 eGFR ** P= <0.01,
Slide 15: Positive CKD Phase 1b Interim Results
DM199 POSITIVE CKD PHASE 1B INTERIM RESULTS Achieved primary endpoints and secondary objectives Well-tolerated with no apparent safety signals + No dose-limiting toxicities identified + No discontinuations or serious adverse events (SAE) Identified Phase Il CKD dosing + PK profile unaffected by stag
Slide 16: Rationale for Investigating DM199 for CKD
Rationale for investigating DM199 for CKD ep DiaMeskta
Slide 17: Mechanism of Action
DM199 MECHANISM OF ACTION DM199 boosts KLK1 levels enabling release of physiological levels of BK when and where needed. Generates beneficial nitric oxide, prostacyclin and anti-inflammaton <— EFFECTS ON EFFECTS ON BRADYKINN BK RECEPTORS. or Be receptor oo Snes = + Regulated & controled Increase of
Slide 18: Multifunctional Serine Protease
DM199 MULTIFUNCTIONAL SERINE PROTEASE Promoting homeostasis: improving blood flow and reducing inflammation throughout the body Suppresses autoimmune response via increased regulatory T cells (Tregs) Increases Tregs + Potential Indications: Type 1 diabetes’, lupus’, IgAN & other autoimmune + DM199 i
Slide 19: KLK1 (Porcine) Data in Patients Highlights
KLK1 (PORCINE) DATA IN PATIENTS HIGHLIGHTS THE POTENTIAL FOR IMPROVING CKD 20+ clinical studies with KLK1 (porcine) demonstrated renal function and in Meta analysis - KLK1 (porcine) for CKD" “clinical efficacy of pancreatic KUKI in treating kidney disease is significant and worthy of wide applicatio
Slide 20: Phase II CKD Trial Overview
DM199 Phase II CKD Trial Overview 2 tg DiMedita
Slide 21: Protein Replacement Therapy Pipeline
DM199 PROTEIN REPLACEMENT THERAPY PIPELINE Could address a diverse pipeline of indications DEVELOPMENT STAGE AND ANTICIPATED MILESTONES PROGRAM | THERAPEUTIC INDICATIONS| PHASE! PHASEI | PHASE III | ANTICIPATED MILESTONES Prose bose Raging ENN Cone compet ne 209 Phase 2 initiation 2H 2019 DM199 IgA
Slide 22: DM199 for IgA Nephropathy (IgAN)
DM199 FOR IGA NEPHROPATHY (IgAN) IGA Nephropathy (IgAN) Overview Cause: IgA, a protein meant to defend the body against foreign invaders, accumulates in the kidneys, attacking glomeruli Diagnosis: Hematuria, albuminuria, hypertension = Prognosis: up to 50% at risk for ESRD within 10-20 years Prevale
Slide 23: DM199 for African Americans with CKD (APOL1)
DM199 FOR AFRICAN AMERICANS WITH CKD (APOL1) CKD in African Americans & APO! Overview = African Americans 3-4x more likely to suffer kidney failure than Caucasians © APOL1 gene variations are 2x more likely to progress to ESRD = APOLL is a gene that affects arterial blood flow in kidneys = CKD short
Slide 24: Phase II CKD Draft Study Design
DM199 PHASE II CKD DRAFT STUDY DESIGN Targeting multiple rare / unmet forms of chronic kidney diseases i-Center US, Randomized Study an Americans-APOL1 gene with Kidney Disease 30 participants per cohort ticipants to act as their Endpoint DM199 dose 1 aah based on Phase ib results Day? Week 12 Study
Slide 25: DiaMedica closing summary
Sz DiaMed "2 DiaMedica \S U AWS THERAPEUTICS Crude form of KLK1 approved and treated miillions successfully in Asia Nasdaq: DMAC Early DM199 signals in mechanism biomarkers, kidney function & urine albumin DM199 (recombinant KLK1) as a safe treatment option for CKD patients
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