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Aridis Investor Presentation 2Q21

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Aridis Investor Presentation 2Q21 Innovative Therapeutics For Respiratory Health Investor Presentation 2Q-2021 1 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 are not guaranties time. It is not possible for our management to predict all risks, nor can we assess the impact of all of future performance. An investment in the securities of Aridis is speculative in nature, involves a factors on our business or the extent to which any factor, or combination of factors, may cause actual high degree of risk, and should not be made by an investor who cannot bear the economic risk of its results to differ materially from those contained in any forward-looking statements we may make. In investment for an indefinite period of time and who cannot afford the loss of its entire investment. light of these risks, uncertainties and assumptions, the forward-looking events and circumstances These include many important factors that affect our ability to achieve our stated objectives including, discussed in this presentation may not occur and actual results could differ materially and adversely but not limited to: from those anticipated or implied in the forward-looking statements. * The timing of regulatory submissions; Except as required by law, neither we nor any other person assumes responsibility for the accuracy * Our ability to obtain and maintain regulatory approval of our existing product candidates and any and completeness of the forward-looking statements. We undertake no obligation to update publicly other product candidates we may develop, and the labeling under any approval we may obtain; any forward-looking statements for any reason after the date of this presentation to conform these * Approvals for clinical trials may be delayed or withheld by regulatory agencies; statements to actual results or to changes in our expectations. * Pre-clinical and clinical studies will not be successful or confirm earlier results or meet expecta- tions or meet regulatory requirements or meet performance thresholds for commercial success; We have filed a registration statement (including a prospectus) with the Securities and Exchange * The timing and costs of clinical trials, the timing and costs of other expenses; Commission ("SEC") for the offering to which this communication relates. Before you invest, you * Our ability to obtain funding from third parties; should read the prospectus in the registration statement and other documents we have filed with the * Management and employee operations and execution risks; SEC for more complete information about us and this offering. You may get these documents for free * Loss of key personnel; by visiting EDGAR on the SEC web site at http://www.sec.gov. Alternatively, we, any underwriter, or * Competition; any dealer participating in the offering will arrange to send you the prospectus if you request it from * Market acceptance of products; Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor, New York, NY * Intellectual property risks; 10022; email: [email protected]. This presentation shall not constitute an offer to sell or the * Assumptions regarding the size of the available market, benefits of our products, product pricing, solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any timing of product launches; state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or * The uncertainty of future financial results; qualification under the securities laws of any such state or jurisdiction. * Risks associated with this offering; * Our ability to attract collaborators and partners; * Our reliance on third party organizations. 2 Product Pipeline Next Products Targets Pre-Clinical IND Phase 1 Phase 2 Phase 3 Milestone AR-301 mAb Gram (+) Bacteria Interim Futility Pneumonia & Blood Stream Infections (Salvecin) S. aureus a-toxin data 2H2021 AR-101 mAb Gram (-) Bacteria Phase 2/3 (Aerumab) P. aeruginosa LPS O11 HAP/VAP tbd AR-501 Gram (-) & (+) Cystic Fibrosis Phase 2a data (Panaecin) Iron Acquisition Systems 2H2021 AR-712 mAb COVID-19 Phase 1/2 COVID-19 AR-701 RBD mAb 2H2021 tbd AR-401 mAb Gram (-) Bacteria Bacteremia A. baumannii 3 Using Human Monoclonal Antibody for Infections mAb Toxins Monoclonal Antibody (mAb) Antibiotics Bacteria Virus 4 Y TM PEX Monoclonal Antibody Discovery and Production Platform Technology CRISPR Guided Integration Y Convalescent PEXTM Nanoarrays B-cell Cloned CDRs B.R.E.A.T.H. TM GMP COVID-19 patient B-cell Selected or H&L of IgG’s CHO cell line Manufacturing repertoire screening Y PEXY TM Discovery, Development, and Manuf. 12-15 months time saving TRADITIONAL: Discovery, Development, and Manufacturing 0 3 6 9 12 15 18 21 24 27 Months 5 Healthcare Burden: S. aureus and P. aeruginosa Bacteria ~252,000 ICU patients US claims database (2018) n=201 n=394 Survey of 30 cases (median) Hospital Days In-Patient Costs Hospital 44.4% $213,104 60 days 55.4 $220,000 Pharmacy 21.0% Laboratory 16.3% 37.9 $146,978 40 days Respiratory Treatment (Mech. ventilation) 9.3% $110,000 Radiology (+CT Scans) 3.3% 20 days Cardiology 1.9% $33,851 7.2 Operating Room 1.4% Control Staph Pseudomonas Control Staph Pseudomonas Diagnostics (Blood ECG) 1.9% Pulmonary Diagnostic 0.4% ICU stay 1.1 day 6.9 days 14.8 days 1.1 day 6.9 days 14.8 days Orthopeadic 0.3% All Cause 3% 16% 20% 3% 16% 20% Mortality Restrepo (2010) ICHE 31:509-515 Kyaw MH et al., 2015 BMC Health Serv Res. 15:241 6 Interstitium Normal Alveolus AR-301 Mechanism of Action: Alveolar Type 1 cells air space Targets S. aureus α-Toxin Staphylococcus aureus Macrophages α-toxins Anti-toxin monoclonal mAb antibody approach is a PMN Necrosis proven MOA, e.g. α-toxins attacking α-toxins immune cell Commercialized Intact Immune Cell Anthrax mAb Raxibacumab (GSK-EBSI) Under development S. Aureus mAb MEDI4893 (AZN) Gram (+) bacteria: S. aureus Host cells killed by α-toxins Red blood cells T-cells Neutrophils Pneumoncytes Macrophages, Monocytes Endothelial cells Toxins 2013, 5(6), 1140-1166 7 Therapeutic Treatment in Acute Pneumonia Setting Superiority Trial Design Antibiotics-alone Adjunct therapy VS. Standard Standard AR-301 of Care of Care With positive data, provides for value-based premium reimbursement 8 AR-301 Phase 2: 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 + AR-301 (3 mg/kg) n= 8 SOC + AR-301 (10 mg/kg) n=10 SOC + AR-301 (20 mg/kg) n= 8 Primary Endpoint Safety and pharmacokinetics Secondary Endpoint Time to removal of ventilator (VAP patients) Hospitalization days Microbiological cure All-cause mortality Shorter time to eradication Clinical cure rate Days in ICU Francois, B. et al. 2018 Intensive Care Medicine Data trend in favor of adjunctive treatment benefit 9 AR-301: Favorable Phase 2 Safety & PK Data Adjunctive AR-301 treated groups were well 600 (plasma half-life of 23-31 days) ug/mL antibiotics alone (placebo) group (n=48). ation r AR-301 Few adverse events (AEs) deemed related to 400 ent 20 mg/kg AR-301 (2.8%). c ug/mL on C 50% (half-life mark) No serious adverse events (SAEs) related to 200 AR-301. ug/mL lasma P Antibiotic Deaths were deemed unrelated to AR-301 Half Life treatment (n=6). Mean 0 ug/mL 24 48 72 96 120 144 168 (hours) Time since start of infusion 10 100% Antibiotics alone (n=5) Phase 2 tion 80% a eiving c Aggregated AR-301 treated VAP groups til e n R e 60% exhibited lower probability of requiring V 50% y of improvement mechanical ventilation vs. placebo. t 40% obabili echanical r P M 20% +AR-301 Pooled (n=20) 0 5 10 15 20 25 Days on Mechanical Ventilators Francois, B. et al. 2018 Intensive Care Medicine. 11 AR-301 Phase 3: Trial Design 1-to-1 randomized, double-blind, Broad spectrum placebo-controlled, single infusion antibiotics dose IV infusion Enrolling 240 patients with VAP caused by S. aureus across 125 sites in 20 n = 120 Day 21 countries (U.S., EU, Asia) Randomize Test of Evaluating the potential of & Treat Clinical adjunctive AR-301 (20 mg/kg) Cure to SOC antibiotics vs. n = 120 antibiotics alone Primary endpoint of clinical cure rate at day 21 Interim futility analysis of 120 patients Broad in 2H2021 and final data AR-301 at 20 mg/kg spectrum IV infusion readout in 1H2022 antibiotics (ClinicalTrials.gov ID NCT03027609) 12 AR-301 Phase 3 Study Powering Calculation and Assumptions Primary Endpoint: Clinical Cure Rate Study Control AR-301 Absolute Evaluable Total Power (SOC)* + SOC ** per group Enrolled 80% 75% 95% 20% n = 55 n = 110 90% 75% 95% 20% n = 69 n = 138 n = 240 enrollment target ** Rationale for 20% absolute over-powered to achieve clinical cure rate improvement setting superior clinical cure rate Considered clinically meaningful to physicians p<0.05 Ph2a data showed trend toward improvements in shorter ventilation time & microbiological eradication (i.e. 2 of the 3 components of the primary endpoint) 13 $6 Billion Market for (AR-301): VAP, HAP Gram (+) Staphylococcus aureus-Induced HAP/VAP Estimated $6 billion annual healthcare cost burden attributable to S. aureus nosocomial pneumonia 395,000 Patients in the US, Japan, EU Breakdown MRSA 52% of Strains MSSA 48% Potential S.
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