Aridis Pharmaceuticals Inc. · OTC:ARDS
Aridis Pharmaceuticals — Investor Presentation (November 2022)
30 slides from Aridis Pharmaceuticals's investor presentation, November 2022
Slide 1: Innovative Therapeutics For Respiratory Health
Innovative Therapeutics For Respiratory Health Investor Presentation 3Q-2022 1
Slide 2: Forward Looking Statement
Forward Looking Statement These forward-looking statements relate to future events or future financial performance of the We operate in a very competitive and rapidly changing environment. New risks emerge from time to Company. All such forward-looking statements involve risks and uncertainties and
Slide 3: Corporate Summary
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 Clinical data readouts in
Slide 4: Employing Human Monoclonal Antibody for Infections
Employing Human Monoclonal Antibody for Infections mAb Monoclonal Toxins Antibody (mAb) Antibiotics Bacteria Virus Benefits of mAbs: Targeted, Durability of action, Predictable safety 4
Slide 5: Product Pipeline
Product Pipeline Products Targets Pre-Clinical IND Phase 1 Phase 2 Phase 3 Next Milestone AR-301 mAb Gram (+) Bacteria Pneumonia Treatment Phase 3 (tosotoxumab) S. aureus a -toxin data 2H2022 AR-320 mAb Gram (+) Bacteria Phase 3 (suvratoxumab) Pneumonia Prevention Interim Futility S. aureus a-toxin
Slide 6: Healthcare Burden of S. aureus Bacterial Infections
Healthcare Burden of S. aureus Bacterial Infections ~252,000 ICU patients US claims database (2018)* n=201 n=394 Survey of 30 cases (median) Hospital In-Patient Hospital 44.4% 60 days Days $220,000 Costs Pharmacy 21.0% Laboratory 16.3% 37.9 $146,978 40 days Respiratory Treatment (Mech. ventilation)
Slide 7: $6 Billion Market for S. aureus HAP/VAP
$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 MRSA 52% of Strains MSSA 48% Potential S. aureus HAP/VAP
Slide 8: AR-301 & AR-320 Mechanism of Action
AR-301 & AR-320 Normal Interstitium Mechanism of Action: Alveolus Targets S. aureus α-Toxin Type 1 cells Alveolar Staphyllococcus air aureus space α-toxins Macrophages Anti-toxin monoclonal mAb antibody approach is a PMN α-toxins Necrosis attacking proven MOA, e.g. immune cell α-toxins Commercialize
Slide 9: AR-320 (suvratoxumab)
AR-320 (suvratoxumab) Prevention of acute pneumonia in S. aureus colonized, mechanically ventilated ICU patients 9
Slide 10: AR-320: Favorable Phase 1 and 2 PK and Safety Data
AR-320: Favorable Phase 1 & 2 PK and Safety Data Exceptionally long plasma half-life Phase 1 Healthy Adults (n=36) 10,000 (T1/2 of 80 to 112 days) Few adverse events (AEs) deemed related to AR-320 Mean Serum Concentration Suvratoxumab demonstrated a favorable safety 1,000 5,000 mg (ug/mL) Half-life
Slide 11: AR-320: Phase 2 'SAATELLITE' Study Completed
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 pneum
Slide 12: AR-320 Phase 2: Attained Statistical Significance (<65yrs old)
AR-320 Phase 2: Attained Statistical Significance ( < 65yrs old) All subjects Pre-Specified Groups (mITT) <65 yrs old 5 VAP bundles** Low S. aureus Relative Risk Reduction of S.aureus burden Pneumonia Compared to Placebo 10 0 n =196 n =128 n =101 n =72 -10 -20 (%) -30 p-value -40 0.166 -50 p-value p-
Slide 13: AR-320 Phase 2: Pharmacoeconomic outcomes for target population
AR-320 Phase 2: Pharmacoeconmic outcomes for the Phase 3 target population (<65 yrs old) Net Difference compared to Placebo Healthcare Utilization (Mean days) 40 39.1 Hospitalization Mechanical Healthcare Utilization (Mean days) days ICU days ventilation days 35 0 30.3 30 -1 25 -3 1.9 days 20.0 3.3
Slide 14: AR-320 Phase 3 'SAATELLITE-2' Trial Design
AR-320 Phase 3 ‘SAATELLITE-2’ Trial Design 1-to-1 randomized, double-blind, placebo- controlled, single dose IV Targeting 564 patients (12 to 65yrs old) colonized w/S. aureus (no VAP) across IV 200 sites in ~20 countries (U.S., EU, Asia) infusion n = 282 S.a. colonization 30-Day confirmation by PCR,
Slide 15: AR-301 (tosatoxumab)
AR-301 (tosatoxumab) Treatment of S. aureus ventilator associated pneumonia 15
Slide 16: AR-301: Therapeutic Treatment of Acute Pneumonia
AR-301: Therapeutic Treatment of Acute Pneumonia Superiority Trial Design Antibiotics alone Adjunct therapy VS. Standard Standard of Care AR-301 of Care With positive data, provides for value-based premium reimbursement 16
Slide 17: AR-301 Phase 2a: Trial Recently Completed
AR-301 Phase 2a: Trial Recently Completed Design Randomized, double-blind, placebo-controlled, single ascending dose of AR-301 31 sites across EU and U.S. Patient Selection 48 patients with HAP or VAP caused by S. aureus Groups SOC [antibiotics alone] + Placebo n=16 SOC + AR-301 (1 mg/kg ) n= 6 SOC
Slide 18: AR-301 Phase 2 Efficacy: Time on Mech. Ventilation
AR-301 Phase 2 Efficacy: Time on Mech. Ventilation 100% Probability of Receiving Antibiotics alone (n=5) Mechanical Ventilation 80% Phase 2 60% 50% Aggregated AR-301 treated VAP groups improvement exhibited lower probability of requiring 40% mechanical ventilation vs. placebo. 20% +AR-301 Pooled (n=
Slide 19: AR-301 Phase 3 (on-going): Trial Design
AR-301 Phase 3 (on-going): Trial Design Broad Placebo buffer spectrum 1-to-1 randomized, double-blind, IV infusion antibiotics placebo-controlled, single dose I.V. Evaluating the potential of adjunctive AR-301 (20 mg/kg) to n = 120 SOC antibiotics vs. antibiotics alone Day 21 Randomize Test of & Tre
Slide 20: AR-301 Phase 3: Powering Calculation and Assumptions
AR-301 Phase 3: Powering Calculation and Assumptions Primary Endpoint: Clinical Cure Rate Study Control AR-301 Absolute mITT Total Power (p<0.05) (SOC) + SOC Difference per group Enrolled 80% 75% 95% 20% n = 55 n = 110 90% 75% 95% 20% n = 69 n = 138 Phase 3 enrollment target = 240 patients* (i.e. ov
Slide 21: Covering Prevention and Treatment of S.a. HAP/VAP
Covering Prevention and Treatment of S.a. HAP/VAP Projecting $1Bn+ market opportunity for each candidate AR-320 AR-301 $2,500 Suvratoxumab Tosatoxumab Prevention Treatment Total Lung colonized, high risk but Confirmed infection does not yet have VAP $2,000 ventilator-assoc. pneumonia Total Sales ($m
Slide 22: AR-501: Novel Inhaled Non-Antibiotic
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 22
Slide 23: AR-501 Phase 1/2: Healthy & Cystic Fibrosis Patients
AR-501 Phase 1/2: Healthy & Cystic Fibrosis Patients CF Foundation Funded Phase 1 Healthy Volunteers PARI eFlow Phase 2 Cystic Fibrosis Patients nebulizer (on-going) Single Ascending Dose Done 6 mg 20 mg 40 mg Multiple Ascending Doses t = 0, 1, 2 weeks 18 patients 6 patients AR-501 Placebo Primary E
Slide 24: Single IV dose of gallium improved lung infection
A single IV dose of gallium resulted in statistical significant improvement in lung infection Proxy Data: 10% Intent to Treat Population CF Safety & Efficacy of Mean Relative Change from Patients 8% IV Gallium Inhaled Baseline in FEV1 (L) 6% 4% Demonstrated mg/mL Delivery Gallium 2% 0% 300 -2% Sputu
Slide 25: AR-701: COVID-19 mAb Cocktail for I.M. & Inhalation
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 mice, hamster, and non
Slide 26: Key Milestones: Multiple clinical data readouts in 2022
Key Milestones: Multiple clinical data readouts in 2022 2022 2023 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 AR-301 Phase 3 Data Toxin Blocker AR-320 Phase 3 Initiation Toxin Blocker AR-501 Phase 2a Data Phase 2/3 Cystic Fibrosis AR-701 Phase 1 COVID-19 26
Slide 27: PEX Monoclonal Antibody Discovery & Production Platform Technology
lPEX Monoclonal Antibody Discovery & TM Production Platform Technology CRISPR Guided Integration Y Convalescent PEXTM Nanoarrays B-cell Cloned CDRs B.R.E.A.T.H. TM GMP COVID-19 B-cell repertoire Selected or H&L of IgG’s CHO cell line Manufacturing patient screening Y PEXTM Discovery, Development, an
Slide 28: Financial Information
Financial Information As of 03/31/2021 ▪ Cash & Cash Equivalents $12.5m ▪ Q4 Burn $ 5.7m ▪ Shares Authorized 100m ▪ Shares Outstanding 17,701,592 Analyst Coverage ▪ HC Wainwright ( Vernon Bernadino) ▪ ROTH Capital (Jonathan Aschoff ) ▪ Maxim Group (Jason MacCarthy) ▪ Northland Securities (Carl Byrne
Slide 29: Senior Management
Senior Management Vu Truong Hasan Jafri CEO, Director Chief Medical Officer (Medimmune, Aviron) (AstraZeneca/Medimmune) Fred Kurland Franco Merckling Chief Financial Officer SVP, Operations (XOMA, PDL, Aviron) (Eli Lilly, Eisai, Merck) Elizabeth Leininger Steve Chamow VP, Regulatory & Quality VP, De
Slide 30: Board of Directors
Board of Directors Eric Patzer, Ph.D. Robert Ruffolo, Ph.D., D.Sc. Chairman (Former President Wyeth/Pfizer) (Co-Founder, Aridis) Vu Truong, Ph.D. Craig Gibbs, Ph.D., M.B.A. (CEO, Aridis) (Commercial Gilead; Genentech) Susan Windham-Bannister, Ph.D. John Hamilton, M.B.A. (Assoc. Women in STEM, Mass.
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