Aridis Pharmaceuticals Inc. · OTC:ARDS
Aridis Pharmaceuticals — Investor Day (December 2020)
27 slides from Aridis Pharmaceuticals's investor day presentation, Dec 4, 2020
Slide 1: Aridis Pharmaceuticals Fireside Chat: Analyst Day & 2021 Outlook Event
Aridis Pharmaceuticals Fireside Chat Analyst Day & 2021 Outlook Event Dec .4th, 2020
Slide 2: Event Agenda
EVENT AGENDA • Welcome comments by CEO: 5 min • Ventilator Associated Pneumonia: Louise Chen (15 min) • Cystic Fibrosis: Carl Byrnes/Vernon Bernardino (15 min) • COVID-19: Jonathan Aschoff (15 min) • APEX Platform: Jason McCarthy (15 min) • Open Q&A: Audience and analyst questions across all indicat
Slide 3: Forward-Looking Statements
Forward-Looking Statements 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 speculati
Slide 4: Welcome! 2021 is a Strong Year for Aridis
Welcome! 2021 is a Strong Year for Aridis Phase 3 Data AR-301 VAP Phase 3 Data Phase 1/2 Data AR-711 COVID-19 AR-711 COVID-19 Q4 Q3 Q2 Phase 2a Data Interim Futility AR-501 CF Q1 Analysis AR-301 Ph3 VAP APEX Partnerships Targeted throughout 2021
Slide 5: AR-301 Phase 3 Program for S.aureus VAP
AR-301 Phase 3 Program for S.aureus VAP Louise Chen, Cantor Fitzgerald Legal Disclosures Lead or Co-manager: Cantor Fitzgerald and/or its affiliates, has acted as lead or co-manager in a public offering of equity and/or debt securities for Aridis Pharmaceuticals Inc. within the last 12 months Invest
Slide 6: Hospital Acquired Bacterial Pneumonia Treatment Landscape
Hospital Acquired Bacterial Pneumonia Treatment Landscape ▪ Hospital-based MRSA typically treated with broad spectrum anti-MRSA agents (vancomycin, linezolid) ▪ Significant need for new anti-MRSA agents given S. aureus resistance of 40% – 50% ▪ Additional unmet needs: new treatment options with bett
Slide 7: AR-301 Product Profile
AR-301 Product Profile ▪ Differentiated immunotherapy approach to treating S. aureus AR-301 mAb bacterial pneumonia ▪ MOA: neutralization of S. aureus toxin, effective vs. MDR strains α-toxins attacking Intact ▪ Phase 3 program with prior positive Phase 2a data immune cell Immune Cell demonstrating
Slide 8: AR-301 Phase 3: Trial Design
AR-301 Phase 3: Trial Design ▪ Superiority trial design ▪ Single IV infusion of AR-301 + SOC versus SOC alone Primary Endpoint: ▪ Global study involving >125 sites in 20 countries Test of Clinical (U.S., EU, Asia) Cure (Day 21) ▪ Primary endpoint = clinical cure rate at day 21 ▪ 2021 Goalposts: • In
Slide 9: VAP Fireside Chat
VAP Fireside Chat Louise Chen Dr. Hasan Jafri, CMO ARDS Dr. Vu Truong, CEO ARDS
Slide 10: AR-301 Phase 3 Design: Powering Assumptions
AR-301 Phase 3 Design: Powering Assumptions • Primary Endpoint of clinical cure has been agreed upon by FDA and EMEA • Clinical cure is a composite endpoint composed of 3 parts: • Mortality • Ventilation time • Resolution of pneumonia • N= 240 ensures a >> 90% power to show a 20% absolute benefit**
Slide 11: Inhaled Anti-infectives for Cystic Fibrosis
Inhaled Anti-infectives for Cystic Fibrosis Carl Byrnes, Northland Securities
Slide 12: Cystic Fibrosis Infection Treatments Landscape
Cystic Fibrosis Infection Treatments Landscape CF has a prevalence of 30,000 patients in the US, typically diagnosed in childhood. ▪ CF patients suffer from chronic respiratory infections secondary to their underlying disease state. ▪ And require lifelong treatment, with regimens comprised of: ▪ CFT
Slide 13: Limitations of Existing SOC Inhaled Antibiotics
Limitations of Existing SOC Inhaled Antibiotics Existing SOC inhaled therapies have limitations and numerous challenges, including: ▪ Limited coverage of problematic pathogens such as MRSA, non-tuberculous mycobacterium, Aspergillus fumigatus, and others; ▪ Increased development of resistance, givin
Slide 14: Addressing an Unmet Medical Need
Addressing an Unmet Medical Need Ideal characteristics of next-gen antibiotic: ▪ Effective against MDR bacterial strains; ▪ Low rate of resistance development; ▪ Synergistic with other antibiotic therapies; ▪ Does NOT interfere with macrophage activity; ▪ Convenient dosing; ▪ Safe and well-tolerated
Slide 15: AR-501 Product Profile
AR-501 Product Profile Pseudomonas aeruginosa ▪ Novel chronically administered inhaled anti-infective ATTC 27853 Strain 1100 √ Broad spectrum, with activity against NTM, fungi, MRSA 500 Tobramycin (ug/mL) MICResistance √ Effective against MDR bacterial strains; 400 300 √ Low rate of resistance devel
Slide 16: Cystic Fibrosis Fireside Chat
Cystic Fibrosis Fireside Chat Carl Byrnes & Vernon Bernardino Dr. Hasan Jafri, CMO ARDS Dr. Vu Truong, CEO ARDS
Slide 17: COVID-19 mAb
Viral vectors DNA RNA Protein Immune response Antibody AZN INO MRNA, PFE NVAX, JNJ REGN, LLY, ARDS COVID-19 mAb Jonathan Aschoff, Ph.D., Roth Capital Disclosure: ROTH makes a market in shares of Aridis Pharmaceuticals, Inc. and as such, buys and sells from customers on a principal basis.“
Slide 18: COVID-19 Vaccine & Treatment Landscape
COVID-19 Vaccine & Treatment Landscape Clinical Trial Pipeline By Phase and Class of Therapies ▪ Unprecedentedly large pipeline of candidates ▪ Strong vaccine data from Pfizer, Moderna, AstraZeneca has validated SARS-CoV-2 spike protein as a clinically relevant target ▪ Commercial roll outs of 5-6 c
Slide 19: What is AR-711
What is AR-711 1. AR-711 is a monoclonal antibody targeting a highly conserved epitope on the receptor-binding domain of the SARS-Cov2 spike protein, Aridis’ APEX platform-aided development • Because Aridis used this highly conserved epitope, AR-711 is IC50 is calculated from dose at which 100% viru
Slide 20: AR-711 Expected Product Profile When on Market
AR-711 Expected Product Profile When on Market ▪ Self-administered, single dose treatment designed for sustained efficacy ▪ Enhanced lung bioavailability and therapeutic index using local, inhaled delivery • Substantially reduce the dose required to achieve treatment benefits • Reduce manufacturing
Slide 21: COVID Mab's Fireside Chat
COVID Mab’s Fireside Chat Dr. Jonathan Aschoff Dr. Hasan Jafri, CMO ARDS Dr. Vu Truong, CEO ARDS
Slide 22: mAb Discovery Platform Technologies
mAb Discovery Platform Technologies Dr. Jason McCarthy, PhD.
Slide 23: Antibody Discovery and Production Challenge
Antibody Discovery and Production Challenge CHALLENGE # 1 CHALLENGE # 2 Rapid functional Immunized or screening of entire Rapid production of Convalescent repertoire for potent, mAb at high titer rare B-cell Size of B-cell repertoire ~1x 106 or more unique cells Immunized
Slide 24: Addressing Challenge #1: Screening Entire B-cell Repertoire for Rare B-Cells
Addressing Challenge # 1: Screening Entire B-cell Repertoire for Rare B-Cells Fluorescently labeled A) B) Antigen Ag detection antibody C) (proteins, viruses, bacteria, etc. Antibody 75µm 75µm 100µm B-cells or CHO 30µm 30µm
Slide 25: Addressing Challenge #2: Rapid Production of MAbs Using CRISPR
Addressing Challenge # 2: Rapid Production of MAbs Using CRISPR Site-specific CRISPR guided integration Selected Cloned CDRs B.R.E.A.T.HTM Nanoculture GMP B-cell or H&L CHO Clonal Select production of IgG’s
Slide 26: APEX Platform Fireside Chat
APEX Platform Fireside Chat Dr. Jason McCarthy Dr. Hasan Jafri, CMO ARDS Dr. Vu Truong, CEO ARDS
Slide 27: Open Q&A Session
Open Q&A Session Analyst &/or Audience Questions Across all Aridis’ Indications and Molecules
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