Aridis Pharmaceuticals Inc. · OTC:ARDS
Aridis Pharmaceuticals — Investor Presentation (February 2023)
34 slides from Aridis Pharmaceuticals's investor presentation, February 2023
Slide 1: Innovative Therapeutics For Respiratory Health
Innovative Therapeutics For Respiratory Health Investor Presentation 1Q-2023 Aridis Pharmaceuticals 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 & 3 clinical data in patients, supporting safety & efficacy Clinical data readout
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 Aridis Pharmaceuticals 4
Slide 5: Product Pipeline
Product Pipeline Products Targets Pre-Clinical IND Phase 1 Phase 2 Phase 3 Next Milestone FDA/EMA AR-301 mAb Gram (+) Bacteria Pneumonia Treatment meeting on (tosotoxumab) S. aureus a -toxin Ph3 data 1H23 AR-320 mAb Gram (+) Bacteria Phase 3 (suvratoxumab) Pneumonia Prevention Interim Futility S. au
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-301 (tosatoxumab)
AR-301 (tosatoxumab) Treatment of S. aureus ventilator associated pneumonia Aridis Pharmaceuticals 9
Slide 10: 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 Aridis Pharmaceuticals 10
Slide 11: AR-301 Phase 3 (completed): Trial Design
AR-301 Phase 3 (completed): 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 & Tr
Slide 12: AR-301-002 Study Population and Safety Summary
AR-301-002 Study Population and Safety Summary SOC + SOC + Overall • There were no meaningful imbalances between Placebo AR-301 Number of Subjects treatment groups in the Safety population or the 85 89 174 micro-FAS population Randomized and Dosed Full Analysis Set (FAS) • There were no SAEs that we
Slide 13: AR-301-002 Primary Efficacy
AR-301-002 Primary Efficacy ➢ AR-301 did not reach statistical significance in the primary endpoint ▪ No meaningful improvement was observed in past antibiotic trials *all are non-inferiority studies HAP/VAP studies, all p-value =n.s. Aridis Pharmaceuticals 13
Slide 14: AR-301 Efficacy Was Increased in Older Adults (65+ yrs)
AR-301 Efficacy Was Increased in Older Adults (65+ yrs) ➢ AR-301 efficacy increase was primarily driven by lower antibiotic effectiveness in older adults (65+ yrs*) Clinical Cure of Pneumonia (Efficacy) 80% 68.9% 70% 11.3% 33.6% 64.0% 37.9% 64.0% 60% 57.6% 50% 40% 30.4% 30% 26.1% 20% 10% (34/59) (42
Slide 15: AR-301 Efficacy was Increased in MRSA patients
AR-301 Efficacy was Increased in MRSA patients Clinical Cure of Pneumonia (Efficacy) ➢ AR-301 efficacy trend was increased in MRSA (antibiotic resistant) patients Higher clinical cure from SOC Antibiotics in less vulnerable subjects: • <65 years old: 75% (27/36) *SOC = standard of care antibiotic; ‘
Slide 16: AR-301 Efficacy Trend Was Increased with Sub-Optimal Antibiotics
AR-301 Efficacy Trend Was Increased in Patients Treated with Sub-Optimal Antibiotics *Trends, no group with p-value <0.05 Aridis Pharmaceuticals 16
Slide 17: AR-301 Reduced Duration of Hospital & ICU Stay, and MV
AR-301 Reduced Duration of Hospital & ICU Stay, and MV Net difference compared to SOC Abx Healthcare Utilization (Median days) Hospitalization Mechanical days ICU days ventilation days 0 -1 -3 2 days -5 -7 7 days -9 -11 9 days ‘SOC Abx’: Standard of care antibiotics; ‘MV’: Mechanical ventilation; ‘I
Slide 18: AR-301-002 Study Conclusions
AR-301-002 Study Conclusions ▪ Clinical cure at Day 21 was 68.9% (42/61 patients) for AR-301 + SOC versus 57.6% (34/59) for SOC alone, (efficacy difference or absolute efficacy: 11.3%, [p= 0.23]). AR-301 did not reach statistical significance in the primary endpoint. ▪ Consistent trends were observe
Slide 19: AR-320 (suvratoxumab)
AR-320 (suvratoxumab) Prevention of acute pneumonia in S. aureus colonized, mechanically ventilated ICU patients Aridis Pharmaceuticals 19
Slide 20: AR-320: Favorable Phase 1 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 21: 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 22: 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 23: AR-320 Phase 2: Pharmacoeconomic outcomes for Phase 3 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 24: 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 25: Projecting $1Bn+ market opportunity for each candidate
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 26: 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 Aridis Pharmaceu
Slide 27: 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 28: 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 29: 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 30: Key Milestones
Key Milestones 2023 2024 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 AR-301 Phase 3 Data FDA & EMA meetings Phase 3b Initiation Toxin Blocker Phase 3 AR-320 Interim futility Toxin Blocker AR-501 Phase 2a Data Phase 2b/3 Cystic Fibrosis Initiation Aridis Pharmaceuticals 30
Slide 31: lPEX 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 32: Financial Information
Financial Information As of 9/30/2022 ▪ Cash & Cash Equivalents $3.1m & $13m* ▪ Q3 Burn $ 4.3m ▪ Shares Authorized 100m ▪ Shares Outstanding 17,701,592 Analyst Coverage ▪ HC Wainwright ( Vernon Bernadino) ▪ Maxim Group (Jason MacCarthy) ▪ Northland Securities (Carl Byrnes) *4Q‘22 Aridis Pharmaceutic
Slide 33: 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 34: 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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