Aridis Pharmaceuticals Inc. · OTC:ARDS
Aridis Pharmaceuticals — Investor Presentation (February 2024)
26 slides from Aridis Pharmaceuticals's investor presentation, February 2024
Slide 1: Innovative Therapeutics For Respiratory Health
Innovative Therapeutics For Respiratory Health Investor Presentation 1H-2024 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 focusing on infectious disease product candidates ▪ Phase 3 asset AR-301 is being developed as an adjunctive treatment in acute pneumonia ▪ ~$1 Billion market opportunity ▪ Strong Phase 2 & 3 clinical data in patients, supporting safety & efficacy Phase
Slide 4: Product Pipeline
Product Pipeline Products Targets Pre-Clinical IND Phase 1 Phase 2 Phase 3 Next Milestone Initiation of AR-301 mAb Gram (+) Bacteria Pneumonia Treatment Confirmatory (tosotoxumab) S. aureus a -toxin Phase 3 AR-320 mAb Gram (+) Bacteria (suvratoxumab) Pneumonia Prevention Study on hold S. aureus a-to
Slide 5: 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 6: $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 7: The Ingenuity Behind AR-301
The Ingenuity Behind AR-301 ▪ S. aureus alpha-toxin impairs host immune response, substantially increases vulnerability to infections, especially in patients with declining immune capacity (e.g. older adults and immunocompromised patients) ▪ Antibiotics are ineffective against bacterial toxins ▪ AR-
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 ▪ While trials were designed for non-inferiority, no meaningful improvement was observed in past antibiotic trials *all are non-inferiority studies HAP/VAP studies, all p-value =n.s. Aridis Pharmaceut
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% 11.2% 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: Data Interpretation
Data Interpretation + Antibiotics alone Young High Cure Rate Immune Capacity + Antibiotics Higher Cure Rate + Old + Antibiotics alone Lower Cure Rate + Antibiotics or S. aureus infected High Cure Rate + Aridis Pharmaceuticals 15
Slide 16: AR-301 Efficacy was Increased in MRSA patients
AR-301 Efficacy was Increased in MRSA patients ➢ AR-301 efficacy trend was increased in MRSA (antibiotic resistant) patients Clinical Cure of Pneumonia (Efficacy) Higher clinical cure from SOC Antibiotics in less vulnerable subjects: • <65 years old: 75% (27/36) *SOC = standard of care antibiotic; ‘
Slide 17: AR-301 Efficacy Trend in Sub-Optimal Antibiotics
AR-301 Efficacy Trend Was Increased in Patients Treated with Sub-Optimal Antibiotics Clinical Cure of Pneumonia (Efficacy) *Trends, no group with p-value <0.05 Aridis Pharmaceuticals 17
Slide 18: 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 19: 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 20: 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 21: 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 Completed 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 En
Slide 22: Sputum concentration
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 23: AR-701: COVID-19 mAb for I.M. & Inhalation
AR-701: COVID-19 mAb for I.M. & Inhalation Receptor binding domain (RBD) – Broad, pan-coronavirus mAb utilizing a differentiated mechanism of action • Effective against Omicron, more future-proof against SARS-COV2 variants SARS-COV2 Spike Protein Stalk (S2) • Effective against SARS, MERS, seasonal h
Slide 24: 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 25: 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 VP, Regulatory & Quality (FDA, GSK, Chiron/N
Slide 26: Board of Directors
Board of Directors Eric Patzer, Ph.D. Susan Windham-Bannister, Ph.D. Chairman (Assoc. Women in STEM, Mass. Life Sci. Ctr) (Co-Founder, Aridis) Vu Truong, Ph.D. John Hamilton, M.B.A. (CEO, Aridis) (CFO, Depomed; BioMarin) Aridis Pharmaceuticals 26
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