Slide 1: ReMEDy PII Trial Acute Ischemic Stroke Top-Line Results
ReMEDy PIl Trial la M ed ICa Acute Ischemic Stroke AWS THERAPEUTICS Top-Line Results Nasdaq: DMAC May 14 2020
Slide 2: Cautionary Note Regarding Forward-Looking Statements
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the US. Private Securities Litigation Reform Act of 1995, which reflect the Company's current expectation regarding future events. The words ‘estimate’, "believe", "antici
Slide 3: Key Takeaways from ReMEDy Phase II Study
KEY TAKEAWAYS FROM REMEDY PHASE II STUDY @ DM199 was safe and well tolerated —- Administered to over 200 participants; positive safety profile which de-risks regulatory pathway DM199 outperformed placebo in AIS patients who did not receive mechanical thrombectomy (MT) prior to enrollment (N=46) © -
Slide 4: Encouraging Trends Observed in ReMEDy
ENCOURAGING TRENDS OBSERVED IN REMEDY Multiple Measurements Reinforce Therapeutic Potential of DM199 and its Mechanism of Action Stroke Recoveries - NIHSS 0 or 1 Stroke Recurrence Risk eGFR A Day 22 (measure of recurrent stroke) (CKD population eGFR <70) 08 S| i — LH Placebo D199 Placebo pMi99 Ne44
Slide 5: ReMEDy Phase II AIS Results
REMEDY PHASE II AIS RESULTS
Slide 6: Significant Unmet Need in Stroke
SIGNIFICANT UNMET NEED IN STROKE Stroke is a Devastating Condition in Great Need of Treatment Options Acute Ischemic Stroke (AIS) Blockage of blood flow in brain > 15 million strokes worldwide > Prevalence in US: ~690,000 per year = Stroke occurs every 40 seconds "Stroke death occurs every 4 minutes
Slide 7: DM199 ReMEDy Trial Design: Phase II Acute Ischemic Stroke Study
DM199 REMEDY TRIAL DESIGN: PHASE 2 ACUTE ISCHEMIC STROKE STUDY Phase II - first dose IV within 24 hours of stroke followed by 21-days subcutaneous (SC) treatment = 92 participants enrolled; 91 evaluable participants = Mild-moderate stroke severity (NIHSS score 6 to 25) at treatment o Patients who re
Slide 8: Summary of DM199 Baseline Characteristics
SUMMARY OF DM199 BASELINE CHARACTERISTICS Safety N=97 M199. (N=46) Age (Years) Mean TALE 69.9 Range 31-95 38-95 Sex n (%) Male 28 (62.2%) 25 (54.3%) Female 17 (87.8%) 21 (45.7%) NIHSS Baseline Score Mean 12.2 11.3 Median 10 10 Administered tPA 18% 28% Mechanical Thrombectomy 27% 35% tPA+MT 27% 11%
Slide 9: DM199 Safe & Well-Tolerated
DM199 SAFE & WELL-TOLERATED DM199 Has Now Been Administered to Over 200 patients = DM199 was safe and well-tolerated (primary end points) = No DM199-related serious adverse events (SAEs) - All evaluations confirmed by independent data safety monitoring board = The most commonly reported adverse even
Slide 10: Stroke Phase Shift Analysis
STROKE PHASE SHIFT ANALYSIS = The NIH Stroke Scale Score (NIHSS) is a tool used to quantify patient impairment caused by a stroke: — Grades various cognitive, motor, speech and sensory tests - The NIHSS stroke score can range from 0 (full recovery) to 42 (death) = The phase shift analysis compares s
Slide 11: tPA (Alteplase) Phase III Stroke Improvement - NIHSS
tPA (ALTEPLASE®) PHASE III STROKE IMPROVEMENT - NIHSS REFERENCE tPA is the Only FDA-Approved Drug Therapy for AIS * Original approval of tPA was for use within 3 hours of stroke onset = Approval study : — 11% absolute increase in full recovery (+55%), NIHSS 0-1 — 4% absolute reduction in deaths (-19
Slide 12: Disproportionate Weighting of Mechanical Thrombectomy Impacts Overall Study Results
DISPROPORTIONATE WEIGHTING OF MECHANICAL THROMBECTOMY IMPACTS OVERALL STUDY RESULTS Future Efficacy Trials Focus on Targeted Patient Population (Excluding MT) = Mechanical thrombectomy (MT) is a catheter- Overall Distribution (n=90) based procedure intended to physically remove the clot 90 day = Pro
Slide 13: DM199 NIHSS Shift Analysis: Target Patient Population (Exclude MT)
DM199 NIHSS SHIFT ANALYSIS: TARGET PATIENT POPULATION (EXCLUDE MT) DM199 Increased Full and Near-Full Recoveries (+157%) and Reduced Deaths (-50%) 24 Hour Therapeutic Window (~6x tPA) rarget Patient Popul: 90 day placebo NIHSS (Neat) 24% 0-1 28 >9 Death DM199 (N=25) 16% 12% 0% 20% 40% 60% 80% 100% D
Slide 14: DM199 Results vs. tPA & Kailikang Approval Studies
DM199 RESULTS VS. tPA & KAILIKANG APPROVAL STUDIES tPA is the Only FDA-Approved Drug for AIS Full Recoveries — Increase in % of NIHSS Scores of 0-1 vs. Placebo* 19% Kailikang® 11% ACTIVASE™ nthe een tPA P3 Study - Urinary KLK1 - DM199 - Hours 0-3 China Non-MT (N=333) (N=260) (N=46) 1. New England Jo
Slide 15: DM199 Reduced Recurrent Strokes
DM199 REDUCED RECURRENT STROKES DM199 Lowered Risk of Recurrent Stroke vs. Placebo Results Consistent with Kailikang®, Human Urinary KLK1! Severe Recurrent Strokes (N=91) P=0,028 7 1 DM199 Placebo N=46 N=44 DM199 May Reduce Recurrent Strokes 1. Brain Behav, Human Urinary Kallidinogenase decreases re
Slide 16: DM199 Significantly Reduces C-Reactive Protein (CRP)
DM199 SIGNIFICANTLY REDUCES C-REACTIVE PROTEIN (CRP) KEY INFLAMMATION BIOMARKER Observed Decrease in DM199 Treated Subjects CRP Levels — Baseline to Day 15 10 12.2 5 * 10.0 Ra Baseline Day 90 Baseline Day 90 DM199 Placebo DM199 Reduced High Cardiovascular Risk (CRP 3 - 10 mg/L) DM199 CRP decreased s
Slide 17: eGFR & Glucose Biomarkers
eGFR & GLUCOSE BIOMARKERS
Slide 18: Change in Kidney Function - eGFR <70 mL/min
CHANGE IN KIDNEY FUNCTION - eGFR < 70 ML/MIN (Pre-Defined Endpoint: eGFR < 70 mL/Min/1.73? at Baseline ) DM199 Increased eGFR +7.5 mL/Min vs Baseline (p=0.017) at Day 22 Trend in eGFR Improvement Maintained 34 Days After Last Dose Last DM199 Dose On Day 22 ~ 4 10 8 pm199 © oe Placebo A aR 58 = 6 5 v
Slide 19: eGFR Changes at Day 22 (Last Dose)
eGFR CHANGES @ DAY 22 (LAST DOSE) Greater Proportion of DM199 Patients with Increased Kidney Function ‘% of patients Greater Than: DM199 (N=13) Placebo (N=15) A +0 mL/Min 85% 40% +45% 0.02 Vv +1 mL/Min 77% 27% + 50% 0.01 v Vv +2mL/Min 77% 20% +57% 0.007 | +3 mL/Min 62% 20% +42% 0.35 | 19
Slide 20: Change in Glucose - Baseline >6 mmol/L
CHANGE IN GLUCOSE - BASELINE > 7 MMOL/L DM199 Reduced Elevated Blood Glucose Levels by 1.9 Mmol/L vs Baseline (P=0.06) at Day 22 M199 MOA believed to increase insulin Last DM199 Dose 2.0 sensitivity via increasing On Day 22 BI2R to enhance GLUT4 Ww translocation* 10 04 13 -2.0 pmM199 Placebo A -3.0
Slide 21: Changes in Key Mechanism Biomarkers (NO & PGE2)
CHANGES IN KEY MECHANISM BIOMARKERS (NO & PGE2) DM199 Trend in Increased Nitric Oxide and Prostaglandin (PGE2) Levels Change in Nitric Oxide (Serum) Change in PGE2 (Serum) Last DM199 Dose Last DM199 Dose On Day 22 On Day 22 150% wW ww 70% 125% 100% BO% 75% 30% 50% 25% 10% 0% ‘ Day 22 Day 90 Day 22 D
Slide 22: Conclusions & Next Steps
CONCLUSIONS RY & NEXT STEPS 7S
Slide 23: Key Takeaways from ReMEDy Phase II Study
KEY TAKEAWAYS FROM REMEDY PHASE II STUDY @ DM199 was safe and well tolerated —- Administered to over 200 participants; positive safety profile which de-risks regulatory pathway DM199 outperformed placebo in AIS patients who did not receive mechanical thrombectomy (MT) prior to enrollment (N=46) © -
Slide 24: Next Steps
NEXT STEPS Remedy Study Results Are Encouraging and Support Moving to the Next Level Meet with Regulators to Discuss ReMEDy Results, Future AIS Study Requirements and = Maintain Tight Breakthrough Therapy / Accelerated Review Fiscal Discipline = Laser-Focused On Completion of REDUX PII Study for CKD
Slide 25: Key Upcoming Phase II Milestone in CKD
KEY UPCOMING PHASE II MILESTONE IN CKD Ongoing 60 Patient Phase II Study in CKD IgA Nephropathy _ REDUX PHASE 2 CKD © Trial Design = Two cohorts: IgA Nephropathy and Hypertensive African Americans (non- diabetic), with 30 patients in each = Accessing two dose levels of DM199: 2 and 5 g/kg (SubQ dosi
Slide 26: NZ 77S
NZ 77S