Aridis Investor Presentation 1Q21Investor Presentation 1Q-2021
Forward Looking Statement
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 speculative in nature, involves a high degree of risk, and should not be made by an investor who cannot bear the economic risk of its investment for an indefinite period of time and who cannot afford the loss of its entire investment. These include many important factors that affect our ability to achieve our stated objectives including, but not limited to:
* The timing of regulatory submissions; * Our ability to obtain and maintain regulatory approval of our existing product candidates and any
other product candidates we may develop, and the labeling under any approval we may obtain; * Approvals for clinical trials may be delayed or withheld by regulatory agencies; * 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; * The timing and costs of clinical trials, the timing and costs of other expenses; * Our ability to obtain funding from third parties; * Management and employee operations and execution risks; * Loss of key personnel; * Competition; * Market acceptance of products; * Intellectual property risks; * Assumptions regarding the size of the available market, benefits of our products, product pricing,
timing of product launches; * The uncertainty of future financial results; * Risks associated with this offering; * Our ability to attract collaborators and partners; * Our reliance on third party organizations.
We operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this presentation to conform these statements to actual results or to changes in our expectations.
We have filed a registration statement (including a prospectus) with the Securities and Exchange Commission ("SEC") for the offering to which this communication relates. Before you invest, you should read the prospectus in the registration statement and other documents we have filed with the SEC for more complete information about us and this offering. You may get these documents for free by visiting EDGAR on the SEC web site at http://www.sec.gov. Alternatively, we, any underwriter, or any dealer participating in the offering will arrange to send you the prospectus if you request it from Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor, New York, NY 10022; email: prospectus@cantor.com. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
3
Gram (+) Bacteria S. aureus a-toxin Pneumonia & Blood Stream Infections
HAP/VAP
Gram (-) & (+) Iron Acquisition Systems
5
30
Months
TRADITIONAL: Discovery, Development, and Manufacturing
APEX TM Discovery, Development, and Manuf. 12-15 months time saving
Convalescent COVID-19 patient
APEX TM Nanoarrays B-cell
6
Kyaw MH et al., 2015 BMC Health Serv Res. 15:241
Restrepo (2010) ICHE 31:509-515
37.9
55.4
$33,851
$146,978
3% 16% 20%
3% 16% 20%
n=201 n=394
Hospital 44.4%
%0.12 ycamrahP
%3.61 yrotarobaL
Radiology (+CT Scans) 3.3%
7
Anthrax mAb Raxibacumab (GSK-EBSI)
Intact Immune Cell
Toxins 2013, 5(6), 1140-1166
T-cells Pneumoncytes Endothelial cells
AR-301 Mechanism of Action:
Commercialized
Therapeutic Treatment in Acute Pneumonia Setting
9
31 sites across EU and U.S.
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
48 patients with HAP or VAP caused by S. aureus
Safety and pharmacokinetics
Time to removal of ventilator (VAP patients)
Microbiological cure
10
50% (half-life mark)
ug/mL
Few adverse events (AEs) deemed related to AR-301 (2.8%).
No serious adverse events (SAEs) related to AR-301.
Deaths were deemed unrelated to AR-301 treatment (n=6).
(plasma half-life of 23-31 days)
AR-301
11
100%
80%
60%
Aggregated AR-301 treated VAP groups exhibited lower probability of requiring mechanical ventilation vs. placebo.
Phase 2
1-to-1 randomized, double-blind, placebo-controlled, single dose IV infusion
Enrolling 240 patients with VAP caused by S. aureus across 125 sites in 20 countries (U.S., EU, Asia)
Evaluating the potential of adjunctive AR-301 (20 mg/kg) to SOC antibiotics vs. antibiotics alone
Primary endpoint of clinical cure rate at day 21
Interim futility analysis of 120 patients
readout in 1H2022
Test of Clinical
n = 120 Day 21
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Powering Calculation and Assumptions
n = 240 enrollment target over-powered to achieve superior clinical cure rate p<0.05
** Rationale for 20% absolute clinical cure rate improvement setting
Considered clinically meaningful to physicians
Ph2a data showed trend toward improvements in shorter ventilation time & microbiological eradication (i.e. 2 of the 3 components of the primary endpoint)
AR-301 Phase 3 Study
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Gram (+) Staphylococcus aureus-Induced HAP/VAP
Lifecycle opportunities include surgical site, skin/skin structure, UTI, and BSI infections due to S. aureus
Estimated $6 billion annual healthcare cost burden attributable to S. aureus nosocomial pneumonia
Breakdown of Strains 48%
1 DR/Decision Resources, LLC. 2016;
2 Chastre J, and Fagon J-Y, Ventilator-associated pneumonia, State of the Art, Am J Respir Critical Care Med, 2002 (165): 867-903.
3 Warren DK, Outcome and Attributable Cost of VAP among ICU patients in a suburban medical center, Critical Care Med 2003;31(5):1312-7.
MRSA
MSSA
90,000
251,600U.S.A.
Japan
53,700Europe
15
Pneumonia caused by MRSA
AR-301 Product Contribution
Key Assumptions First-line adjunctive treatment MRSA only HAP / VAP / HCAP 60% marketshare US / EU / Japan $10,500 per course
$M ill
io n
(N et
$800
$600
$400
$200
$00 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034
1st Phase 3 2nd Phase 3 BLA & Launch
16
AR-301
Pre-Emptive Treatment In S. Aureus Colonized Patients Also Show Evidence of Clinical Benefits
At-risk (non-infected) Asymptomatic
Lung colonized, High risk Asymptomatic
Decreased risk of VAP 32% Decreased risk of VAP 47% (<65 yrs old)
Full-on lung infection Ventilator-assoc. pneumonia
Prophylactic
Phase 3 (n = 240)
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Mechanism of Action
Small Molecule Anti-infective
Iron (Fe) is necessary for bacterial metabolic functions. AR-501 (gallium, Ga) replaces Fe
AR-501 impairs mulitple bacterial functions
Standard antibiotics inhibit single targets
Ga Gallium
Phase 1 Healthy Volunteers
(1H-2019) Single Ascending Dose
40 mg
(1H-2020) Multiple Ascending Doses
Done AR-501 30 patients 15 patients
Placebo
(2H-2021) Multiple Ascending Doses
t = 0, 1, 2 weeks
Phase 2 Cystic Fibrosis Patients
Primary Endpoint: Safety and PK Secondary Endpoints: Lung function of CF patients (changes in FEV1) Sputum bacteriology
Data Readout: Phase 2a CF subjects in 2H2021
CF Foundation Funded
19
M ea
n Re
la tiv
e Ch
an ge
Inhaled Delivery
A single IV dose of gallium resulted in statistical significant improvement in lung infection
Data from University of Washington: Goss, C. et al. 2018 N. Am. Cystic Fibrosis Conference Abstract #307 (*estimate based on animal PK data)
Safety & Efficacy of IV Gallium Demonstrated
Proxy Data:
*UK, So. Africa, Brazil, Japan SARS-CoV-2 strains
AR-712 two mAbs cocktail bind to COVID’s spike protein, blocking COVID & its variants* from being able to bind
to the host cell.
Highly potent SARS-CoV-2 fully human mAbs from convalescent COVID-19 patients - Proprietary stable inhaled formulation designed for direct lung delivery - Therapeutically eradicated SARS-CoV-2 at ultra low dose (~0.05 mg/kg) in animal challenge model - Up to year-long protection (engineered for plasma half-life extension) - Engineered removal of antibody disease enhancement (ADE) risk
AR-712
AR-712 in-human dosing is the lowest vs. all competitors*
*Scaling to human dose based on animal SARS-CoV-2 challenge study. See https://www.biorxiv.org/content/10.1101/2020.10.14.339150v1
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Convenient self-dosing in-home
Target Populations - Designed to lower the barrier to COVID-19 treatment in outpatients - Treatment mild to moderate COVID-19 non-hospitalized patients - Prophylaxis [elderly, high risk frontline workers, etc]
Phase 1/2 in 2H21
https://www.biorxiv.org/content/10.1101/2020.10.14.339150v1.
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AR-301
AR-101
AR-501
AR-712
Michael Nazak Chief Financial Ocer (Formerly Coherus, intekrin)
Steve Chamow VP, Development (Formerly Genentech, Abgenix)
Hasan Jafri Chief Medical Ocer (Formerly AstraZeneca/Medimmune)
Elizabeth Leininger VP, Regulatory (Formerly FDA, Novartis)
Mitch Rosner VP, Quality (Formerly Synthetic Gen., IDEC)
Lynne Deans VP, Clinical Operations (Formerly Roche, Dermira)
Senior Management
Robert Ruolo, Ph.D., D.Sc. Director (Former President Wyeth/Pzer)
Craig Gibbs, Ph.D., M.B.A. Director (Commercial Gilead; Genentech)
John Hamilton, M.B.A. Director (CFO, Depomed; BioMarin)
Susan Windham-Bannister, Ph.D. Director (Assoc. Women in STEM, Mass. Life Sci. Ctr)
Vu Truong, Ph.D. Director (CEO, Aridis)
Board of Directors