Aridis Pharmaceuticals Inc. · OTC:ARDS
Aridis Pharmaceuticals — Investor Presentation (January 2022)
30 slides from Aridis Pharmaceuticals's investor presentation, Jan 5, 2022
Slide 1: Innovative Therapeutics For Respiratory Health
1 Innovative Therapeutics For Respiratory Health Investor Presentation 1Q-2022
Slide 2: Forward Looking Statement
2 Forward Looking Statement These forward-looking statements relate to future events or future financial performance of the Company. All such forward-looking statements involve risks and uncertainties and are not guaranties of future performance. An investment in the securities of Aridis is speculat
Slide 3: Corporate Summary
3 Corporate Summary Late clinical stage company with two (2) Phase 3 assets ▪ First-in-Class & first-line treatment [AR-301] and prevention [AR-320] of acute pneumonia ▪ ~$1 Billion market opportunities ▪ Strong Phase 2 clinical data in patients, supporting safety & efficacy Near-term clinical data
Slide 4: Employing Human Monoclonal Antibody for Infections
4 Employing Human Monoclonal Antibody for Infections mAb Toxins Monoclonal Antibody (mAb) Antibiotics Virus Bacteria Benefits of mAbs: Targeted, Durability of action, Predictable safety
Slide 5: Product Pipeline
5 Product Pipeline Next Milestone Targets IND Phase 1 Phase 2 Phase 3 Products Pre-Clinical Phase 3 data 2H2022 AR-301 mAb (tosotoxumab) Gram (+) Bacteria S. aureus a -toxin Pneumonia Treatment Phase 3 Global launch 1H2022 AR-320 mAb (suvratoxumab) Gram (+) Bacteria S. aureus a-toxin Pneumonia Preve
Slide 6: Healthcare Burden of S. aureus Bacterial Infections
6 Healthcare Burden of S. aureus Bacterial Infections ~252,000 ICU patients US claims database (2018)* Survey of 30 cases (median) n=201 Hospital Days n=394 In-Patient Costs Hospital Pharmacy Laboratory 44.4% 21.0% 16.3% 60 days $220,000 37.9 40 days Respiratory Treatment (Mech. ventilation) Radiolo
Slide 7: $6 Billion Market for S. aureus HAP/VAP
7 $6 Billion Market for S. aureus HAP/VAP Estimated $6 billion annual healthcare cost burden attributable to S. aureus nosocomial pneumonia3 AR-301 adressable patient population: 648,0001 AR-320 adressable patient popl’n ~1.8 million2 Breakdown of Strains 52% 48% Potential S. aureus HAP/VAP Patients
Slide 8: AR-301 & AR-320 Mechanism of Action
8 AR-301 & AR-320 Mechanism of Action: Interstitium Normal Alveolus Alveolar air space TargetsS. aureus α-Toxin Type 1 cells Staphyllococcus aureus Macrophages α-toxins Anti-toxin monoclonal antibody approach is a proven MOA, e.g. mAb PMN Necrosis α-toxins attacking immune cell Commercialized: α-tox
Slide 9: AR-320 (suvratoxumab) Prevention of acute pneumonia
9 AR-320 (suvratoxumab) Prevention of acute pneumonia in S. aureus colonized, mechanically ventilated ICU patients
Slide 10: AR-320: Favorable Phase 1 & 2 PK and Safety Data
10 5,000 mg 750 mg AR-320: Favorable Phase 1 & 2 PK and Safety Data Exceptionally long plasma half-life (T1/2 of 80 to 112 days) Phase 1 Healthy Adults (n=36) Few adverse events (AEs) deemed related to AR-320 Suvratoxumab demonstrated a favorable safety Half-life extension resulted in exceptionally
Slide 11: AR-320: Phase 2 'SAATELLITE' Study Completed
11 AR-320: Phase 2 ‘SAATELLITE’ Study Completed ▪ Randomized, double blinded, placebo-controlled Phase 2 study in 50 EU & US clinical sites (conducted by AstraZeneca & EU IMI’s COMBACTE Consortium) ▪ Patient population: Intubated ICU patients colonized with S. aureus bacteria but did not yet have pn
Slide 12: AR-320 Phase 2: Attained Statistical Significance (<65yrs old)
12 AR-320 Phase 2: Attained Statistical Significance ( < 65yrs old) Pre-Specified Groups All subjects Low S. aureus (mITT) <65 yrs old 5 VAP bundles** burden 10 n =196 n =128 n =101 n =72 0 -10 -20 -30 -40 -50 -60 (Phase 3 Target Population) -70 p-value 0.069 -80 *p-value < 0.10 is statistically sign
Slide 13: AR-320 Phase 2: Pharmacoeconomic outcomes for the Phase 3 target population
13 Net Difference compared to Placebo 40 Hospitalization days Mechanical ventilation days ICU days 35 0 -1 -3 -5 -7 -9 -11 30 25 1.9 days 20 15 10 8.8 days Hospitalization days ICU days Mechanical ventilation days Placebo AR-320 He a l t h c a r e Utilization (Mean days) 3.3 days 30.3 20.0 16.7 14.6
Slide 14: AR-320 Phase 3 'SAATELLITE-2' Trial Design
14 AR-320 Phase 3 ‘SAATELLITE-2’ Trial Design IV infusion n = 282 30-Day Incidence of all- cause pneumonia* S.a. colonization confirmation by PCR, randomize & dose Evaluating the potential of AR-320 (5,000 mg) to prevent S. aureus pneumonia vs. placebo Single confirmatory Phase 3 prior to BLA Interi
Slide 15: AR-301 (tosatoxumab) Treatment of S. aureus ventilator associated pneumonia
15 AR-301 (tosatoxumab) Treatment of S. aureus ventilator associated pneumonia
Slide 16: AR-301: Therapeutic Treatment of Acute Pneumonia
16 AR-301: Therapeutic Treatment of Acute Pneumonia Superiority Trial Design VS. AR-301 Standard of Care Standard of Care With positive data, provides for value-based premium reimbursement Antibiotics alone Adjunct therapy
Slide 17: AR-301 Phase 2a: Trial Recently Completed
17 AR-301 Phase 2a: Trial Recently Completed Randomized, double-blind, placebo-controlled, single ascending dose of AR-301 31 sites across EU and U.S. Design Patient Selection 48 patients with HAP or VAP caused by S. aureus Groups SOC [antibiotics alone] + Placebo n=16 n= 6 n= 8 n=10 n= 8 SOC + AR-3
Slide 18: AR-301 Phase 2 Efficacy: Time on Mech. Ventilation
18 Phase 2 Aggregated AR-301 treated VAP groups exhibited lower probability of requiring mechanical ventilation vs. placebo. Francois, B. et al. 2018 Intensive Care Medicine. P r obabili t y of R e c eiving M echanical V e n til a tion 100% 80% 60% 40% 20% 0 5 10 15 20 25 Days on Mechanical Ventilat
Slide 19: AR-301 Phase 3 (on-going): Trial Design
19 1-to-1 randomized, double-blind, placebo-controlled, single dose I.V. Evaluating the potential of adjunctive AR-301 (20 mg/kg) to SOC antibiotics vs. antibiotics alone Targeting 240* patients with VAP caused by S. aureus across 125 sites in 20 countries (U.S., EU, Asia) Broad spectrum antibiotics
Slide 20: AR-301 Phase 3: Powering Calculation and Assumptions
20 AR-301 Phase 3: Powering Calculation and Assumptions Primary Endpoint: Clinical Cure Rate Study Power 80% 90% Control (SOC) AR-301 + SOC Absolute Difference mITT per group Total Enrolled (p<0.05) 75% 75% 95% 95% 20% 20% n = 55 n = 69 n = 110 n = 138 Phase 3 enrollment target = 240 patients* (i.e.
Slide 21: Covering Prevention and Treatment of S.a. HAP/VAP
21 Covering Prevention and Treatment of S.a. HAP/VAP Projecting $1Bn+ market opportunity for each candidate AR-320 Suvratoxumab Prevention Lung colonized, high risk but does not yet have VAP AR-301 Tosatoxumab Treatment Confirmed infection ventilator-assoc. pneumonia *Assumptions: MRSA-only VAP, 60%
Slide 22: AR-501: Novel Inhaled Non-Antibiotic Small Molecule Anti-infective
22 AR-501: Novel Inhaled Non-Antibiotic Small Molecule Anti-infective Mechanism of Action Iron (Fe) is necessary for bacterial metabolic functions. AR-501 (gallium, Ga) replaces Fe Ga Gallium AR-501 impairs multiple bacterial functions, while standard antibiotics inhibit single targets
Slide 23: AR-501 Phase 1/2: Healthy & Cystic Fibrosis Patients
23 AR-501 Phase 1/2: Healthy & Cystic Fibrosis Patients CF Foundation Funded Phase 1 Healthy Volunteers Phase 2 Cystic Fibrosis Patients (on-going) PARI eFlow nebulizer Done Single Ascending Dose 6 mg 20 mg 40 mg Multiple Ascending Doses t = 0, 1, 2 weeks 18 patients AR-501 6 patients Placebo 6 mg 2
Slide 24: Single IV dose of gallium improved lung infection
24 A single IV dose of gallium resulted in statistical significant improvement in lung infection Proxy Data: Safety & Efficacy of IV Gallium Demonstrated Intent to Treat Population CF Patients 10% 8% 6% 4% 2% 0% -2% -4% -6% Inhaled Delivery mg/mL Gallium 300 1 Day 6 Days 14 Days 28 Days 56 Days Gall
Slide 25: AR-701: COVID-19 mAb Cocktail for I.M. & Inhalation
25 AR-701: COVID-19 mAb Cocktail for I.M. & Inhalation – Broad, pan-coronavirus cocktail utilizing dual mechanism of action • Effective against Omicron, more future-proof against SARS-COV2 variants • Effective against SARS, MERS, seasonal human coronaviruses – Efficacious in ACE2 & hamster challenge
Slide 26: Key Milestones: Multiple clinical data readouts in 2022
26 Key Milestones: Multiple clinical data readouts in 2022 2023 2022 Q1 Q4 Q3 Q3 Q4 Q1 Q2 Q2 Phase 3 Data AR-301 Toxin Blocker AR-320 Toxin Blocker Phase 3 Initiation AR-501 Cystic Fibrosis Phase 2a Data Phase 2/3 Data AR-701 COVID-19 Phase 1/2 Data
Slide 27: PEX Monoclonal Antibody Discovery & Production Platform Technology
27 l PEXTM Monoclonal Antibody Discovery & Production Platform Technology CRISPR Guided Integration Convalescent COVID-19 patient PEXTM Nanoarrays B-cell repertoire screening B-cell Selected Cloned CDRs or H&L of IgG’s B.R.E.A.T.H. TM CHO cell line GMP Manufacturing PEXTM Discovery,Development, and
Slide 28: Financial Information
28 Financial Information As of 9/30/2021 ▪ Cash & Cash Equivalents ▪ Q3 Burn ▪ Shares Authorized ▪ Shares Outstanding $18.2m $ 8.7m 100m 14,054,036 Analyst Coverage ▪ Cantor Fitzgerald (Louise Chen) ▪ HC Wainwright ( Vernon Bernadino) ▪ ROTH Capital (Jonathan Aschoff ) ▪ Maxim Group (Jason MacCarthy
Slide 29: Senior Management
29 Senior Management Hasan Jafri Chief Medical Officer (AstraZeneca/Medimmune) Vu Truong CEO, Director (Medimmune, Aviron) Fred Kurland Chief Financial Officer (XOMA, PDL, Aviron) Steve Chamow VP, Development (Genentech, Abgenix) Elizabeth Leininger VP, Regulatory & Quality (FDA, GSK, Chiron/Novarti
Slide 30: Board of Directors
30 Board of Directors Eric Patzer, Ph.D. Chairman (Co-Founder, Aridis) Robert Ruffolo, Ph.D., D.Sc. (Former President Wyeth/Pfizer) Craig Gibbs, Ph.D., M.B.A. (Commercial Gilead; Genentech) Vu Truong, Ph.D. (CEO, Aridis) Susan Windham-Bannister, Ph.D. (Assoc. Women in STEM, Mass. Life Sci. Ctr) John
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