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1
Innovative Therapeutics For Respiratory Health
Investor Presentation
1Q-2022
2
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:
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.
*
*
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.
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.
*
*
*
*
*
*
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3
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 clinical data in patients, supporting safety & efficacy
Near-term clinical data readouts in three (3) clinical programs [within 9-12 months]
Seasoned management team
4
Employing Human Monoclonal Antibody for Infections
mAb
Toxins
Monoclonal
Antibody (mAb)
Antibiotics
Virus
Bacteria
Benefits of mAbs: Targeted, Durability of action, Predictable safety
5
Product Pipeline
Next
Milestone
Targets IND Phase 1 Phase 2 Phase 3
Products Pre-Clinical
Phase 3
data 2H2022
AR-301 mAb
(tosotoxumab)
Gram (+) Bacteria
S. aureus a -toxin
Pneumonia Treatment
Phase 3
Global launch
1H2022
AR-320 mAb
(suvratoxumab)
Gram (+) Bacteria
S. aureus a-toxin
Pneumonia Prevention
AR-501
(Panaecin)
Gram (-) & (+)
Iron Pathways
Phase 2a data
1H2022
Cystic Fibrosis
AR-701
mAb
COVID-19 Virus
Spike Protein
Phase 1/2a
1H2022
COVID-19
tbd
Gram (-) Bacteria
A. baumannii
AR-401
mAb
Bacteremia
6
Healthcare Burden of S. aureus Bacterial Infections
~252,000 ICU patients
US claims database (2018)*
Survey of 30 cases (median)
n=201
Hospital
Days
n=394
In-Patient
Costs
Hospital
Pharmacy
Laboratory
44.4%
21.0%
16.3%
60 days $220,000
37.9
40 days
Respiratory Treatment (Mech. ventilation)
Radiology (+CT Scans)
Cardiology
9.3%
3.3%
1.9%
$110,000
20 days
7.2 Operating Room
Diagnostics (Blood ECG)
1.4%
1.9%
Control Staph Control Staph
Pulmonary Diagnostic
Orthopeadic
0.4%
0.3%
ICU stay 1.1 day 6.9 days 1.1 day 6.9 days
All Cause
Mortality
3% 16% 3% 16% Restrepo (2010) ICHE 31:509-515
*Kyaw MH et al., 2015 BMC Health Serv Res. 15:241
$146,978
$33,851
7
$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
of Strains
52%
48%
Potential S. aureus HAP/VAP Patients by Market1
*Sources
337,500 1
2
Paling FP, BMC Infect Dis. 2017;17(1):643
Francois, B. et al. Lancet Inf. Dis. 2021;
https://doi.org/10.1016/S1473-3099(20)30995-6
Warren DK, Outcome and Attributable Cost of VAP among ICU
patients in a suburban medical center, Critical
Care Med 2003;31(5):1312-7.
3
Lifecycle opportunities include surgical site, skin/skin structure, UTI, and BSI infections due to S. aureus
U.S.A. 222,750
Europe
Japan 87,750
MRSA
MSSA
8
AR-301 & AR-320
Mechanism of Action:
Interstitium
Normal
Alveolus
Alveolar
air
space
TargetsS. aureus α-Toxin
Type 1 cells
Staphyllococcus
aureus
Macrophages
α-toxins
Anti-toxin monoclonal
antibody approach is a
proven MOA, e.g.
mAb
PMN
Necrosis
α-toxins
attacking
immune cell
Commercialized:
α-toxins
Intact
immune cell C. Difficile mAb Bezotoxumab (MRK)
Anthrax mAb Raxibacumab (GSK-
EBSI)
Gram (+) bacteria: S. aureus
Host cells killed by α-toxins*
T-cells
Pneumoncytes
Endothelial cells
Red blood cells
Neutrophils
Macrophages, Monocytes
*Toxins 2013, 5(6), 1140-1166
9
AR-320 (suvratoxumab)
Prevention of acute pneumonia in S. aureus colonized,
mechanically ventilated ICU patients
10
5,000 mg
750 mg
AR-320: Favorable Phase 1 & 2 PK and Safety Data
Exceptionally long plasma half-life
(T1/2 of 80 to 112 days)
Phase 1 Healthy Adults (n=36)
Few adverse events (AEs) deemed related to AR-320
Suvratoxumab demonstrated a favorable safety
Half-life extension resulted in exceptionally long
exposure, up to one (1) year post-dose
10,000
1,000
100
10
Phase 2 ICU S. aureus Colonized Patients (n=196)
Adverse events (AEs) , SAEs, deaths were balanced
between Placebo and AR-320
Suvratoxumab demonstrated a favorable safety, PK,
and ADA profile
1
360
300
0 60 120 180 240
Time since start of infusion (days)
Mean
Serum
Concentration
(ug/mL)
11
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 pneumonia
▪ Primary endpoint: Incidence of S. aureus pneumonia* within 30 days post-IV dose (FDA & EMA-negotiated endpoint)
Placebo IV infusion
n = 100
30-Day
Incidence of S. aureus
pneumonia*
S. aureus colonization
confirmation by
PCR,
randomize &
dose n = 96
AR-320 at 5,000mg
IV infusion
*Adjudicated by panel of VAP experts & radiologists who are blinded to the treatment assignment
12
AR-320 Phase 2: Attained Statistical Significance ( < 65yrs old)
Pre-Specified Groups
All subjects
Low S. aureus
(mITT) <65 yrs old 5 VAP bundles**
burden
10
n =196 n =128 n =101 n =72
0
-10
-20
-30
-40
-50
-60
(Phase 3 Target
Population)
-70
p-value
0.069
-80
*p-value < 0.10 is statistically significant per agreement with FDA & EMA, and allowed per FDA Guidance for VAP indication (see FDA Guidance for HAP/VAP, 2013)
**5 VAP Bundles is a clinical outcome improvement assessment (elevation of the head of the bed, daily 'sedation vacation' & daily assessment of readiness to extubate, etc.)
See Francois, B. et al. 2021 Lancet Infectious Diseases
‘mITT’ is microbiological confirmed intend to treat population
Relative
Risk
Reduction
of
S.aureus
Pneumonia
Compared
to
Placebo
(%)
p-value
0.166
p-value p-value
0.075* 0.075*
13
Net Difference compared to Placebo
40 Hospitalization
days
Mechanical
ventilationdays
ICU days
35
0
-1
-3
-5
-7
-9
-11
30
25 1.9 days
20
15
10
8.8 days
Hospitalization days ICU days Mechanical
ventilationdays
Placebo AR-320
Healthcare
Utilization
(Mean
days)
3.3 days
30.3
20.0
16.7
14.6
12.7
Healthcare
Utilization
(Mean
days)
39.1
AR-320 Phase 2: Pharmacoeconmic outcomes for
the Phase 3 target population (<65 yrs old)
14
AR-320 Phase 3 ‘SAATELLITE-2’ Trial Design
IV
infusion
n = 282
30-Day
Incidence of all-
cause pneumonia*
S.a. colonization
confirmation by PCR,
randomize & dose
Evaluating the potential of
AR-320 (5,000 mg) to prevent
S. aureus pneumonia vs. placebo
Single confirmatory Phase 3 prior to BLA
Interim futility analysis
in mid-2023 and final data
readout in 1H2024
n = 282
AR-320 at
5,000mg
IV
infusion
*n=564 translates to ~99% power to achieve p<0.05 for the primary endpoint of All-cause Pneumonia. For
secondary endpoint of All-cause Pneumonia or Death, 564 translates to a power of 90%
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
200 sites in ~20 countries (U.S., EU, Asia)
15
AR-301 (tosatoxumab)
Treatment of S. aureus ventilator associated pneumonia
16
AR-301: Therapeutic Treatment of Acute Pneumonia
Superiority Trial Design
VS.
AR-301
Standard
of Care
Standard
of Care
With positive data, provides for value-based premium reimbursement
Antibiotics alone Adjunct therapy
17
AR-301 Phase 2a: Trial Recently Completed
Randomized, double-blind, placebo-controlled, single ascending dose of AR-301
31 sites across EU and U.S.
Design
Patient Selection 48 patients with HAP or VAP caused by S. aureus
Groups SOC [antibiotics alone] + Placebo n=16
n= 6
n= 8
n=10
n= 8
SOC + AR-301
SOC + AR-301
SOC + AR-301
SOC + AR-301
(1 mg/kg )
(3 mg/kg)
(10 mg/kg)
(20 mg/kg)
Safety and pharmacokinetics
Primary Endpoint
Hospitalization days
All-cause mortality
Clinical cure rate
Secondary Endpoint Time to removal of ventilator (VAP patients)
Microbiological cure
Shorter time to eradication
Days in ICU
Data trend in favor of adjunctive treatment benefit
Francois, B. et al. 2018 Intensive Care Medicine
18
Phase 2
Aggregated AR-301 treated VAP groups
exhibited lower probability of requiring
mechanical ventilation vs. placebo.
Francois, B. et al. 2018 Intensive Care Medicine.
Probability
of
Receiving
Mechanical
Ventilation
100%
80%
60%
40%
20%
0 5 10 15 20 25
Days on Mechanical
Ventilators
improvement
+AR-301 Pooled (n=20)
Antibiotics alone (n=5)
50%
AR-301 Phase 2 Efficacy: Time on Mech. Ventilation
19
1-to-1 randomized, double-blind,
placebo-controlled, single dose I.V.
Evaluating the potential of
adjunctive AR-301 (20 mg/kg) to
SOC antibiotics vs. antibiotics alone
Targeting 240* patients with VAP
caused by S. aureus across 125
sites in 20 countries (U.S., EU, Asia)
Broad
spectrum
antibiotics
n = 120
Day 21
Test of
Clinical
Cure**
Randomize
& Treat
n = 120
Broad
spectrum
antibiotics
AR-301 at 20 mg/kg
IV infusion
Top-line data expected 2H2022
**Sample size at 90% power (p<0.05) [20% absolute effect size]: n=138
*Dependent on extent of COVID-19 related ICU utilization
AR-301 Phase 3 (on-going): Trial Design
(ClinicalTrials.gov ID NCT03027609)
Primary endpoint of clinical
cure rate at day 21
Placebo buffer
IV infusion
20
AR-301 Phase 3: Powering Calculation and Assumptions
Primary Endpoint: Clinical Cure Rate
Study
Power
80%
90%
Control
(SOC)
AR-301
+ SOC
Absolute
Difference
mITT
per group
Total
Enrolled
(p<0.05)
75%
75%
95%
95%
20%
20%
n = 55
n = 69
n = 110
n = 138
Phase 3 enrollment target = 240 patients*
(i.e. over-powered versus n=138 patients to achieve superiority in primary endpoint)
*Dependent on extent of COVID-19 related ICU utilization
‘mITT’ is microbiologically confirmed intent to treat population
21
Covering Prevention and Treatment of S.a. HAP/VAP
Projecting $1Bn+ market opportunity for each candidate
AR-320
Suvratoxumab
Prevention
Lung colonized, high risk but
does not yet have VAP
AR-301
Tosatoxumab
Treatment
Confirmed infection
ventilator-assoc. pneumonia
*Assumptions: MRSA-only VAP, 60% adoption rate due to first-line, $10,000 per regimen
**S. aureus colonized, intubated, without VAP symptoms, $5,000 per regimen, 15% adoption rate
Total
Sales
($millions)
AR- 320
$2,500
Total
$2,000
$1,500
AR-301*
$1,000
AR-320**
AR-301
approval
$500
approval
$0
2022 2024 2026 2028 2030 2032 2034 2036 2038
22
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
23
AR-501 Phase 1/2: Healthy & Cystic Fibrosis Patients
CF Foundation Funded
Phase 1 Healthy Volunteers Phase 2 Cystic Fibrosis Patients
(on-going)
PARI eFlow
nebulizer
Done
Single Ascending Dose
6 mg 20 mg 40 mg Multiple Ascending Doses
t = 0, 1, 2 weeks
18 patients
AR-501
6 patients
Placebo 6 mg 20 mg 40 mg
Primary Endpoint:
Safety and PK
Secondary Endpoints:
Lung function of CF patients (changes in
FEV1)
Sputum bacteriology
30 patients
AR-501
15 patients
Placebo
Done
Multiple Ascending Doses
t = 0, 1, 2, 3, 4 weeks
6 mg 20 mg 40 mg
Ph2a data readout: mid-22
18 patients
AR-501
6 patients
Placebo
Ph1 study results: AR-501 was well tolerated
24
A single IV dose of gallium resulted in statistical
significant improvement in lung infection
Proxy Data:
Safety & Efficacy of
IV Gallium
Demonstrated
Intent to Treat Population CF
Patients
10%
8%
6%
4%
2%
0%
-2%
-4%
-6%
Inhaled
Delivery
mg/mL
Gallium
300
1
Day
6
Days
14
Days
28
Days
56
Days
Gallium
Placebo
60
59
60
57
58
57
Patients
60
56
Patients
59
56
Patients
Patients
Patients
2
Data from University of Washington: Goss, C. et al.
2018 N. Am. Cystic Fibrosis Conference Abstract #307 (*estimate based on animal PK data)
Mean
Relative
Change
from
Baseline
in
FEV1
(L)
Sputum
concentration
Inhaled
(est.)
IV
25
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 & hamster challenge models
– Intramuscular and Inhaled formulation options
– Long-acting, mAbs are half-life extended
– Targeting non-hospitalized COVID population with self-administered, at-
home treatment
– Phase 1/2 data in 2H2022
Self-administered
inhaled formulation
option
26
Key Milestones: Multiple clinical data readouts in 2022
2023
2022
Q1 Q4
Q3
Q3 Q4 Q1
Q2 Q2
Phase 3
Data
AR-301
Toxin Blocker
AR-320
Toxin Blocker
Phase 3
Initiation
AR-501
Cystic Fibrosis
Phase 2a
Data
Phase 2/3
Data
AR-701
COVID-19
Phase 1/2
Data
27
lPEXTM
Monoclonal Antibody Discovery &
Production Platform Technology
CRISPR
Guided
Integration
Convalescent
COVID-19
patient
PEXTM
Nanoarrays
B-cell repertoire
screening
B-cell
Selected
Cloned CDRs
or H&L of IgG’s
B.R.E.A.T.H. TM
CHO cell line
GMP
Manufacturing
PEXTM
Discovery, Development, and Manuf. 12-15 months potential time saving
TRADITIONAL: Discovery, Development, and Manufacturing
0 3 6 9 12 15 18 21 24 27
Months
Y
Y
28
Financial Information
As of 9/30/2021
▪ Cash & Cash Equivalents
▪ Q3Burn
▪ Shares Authorized
▪ Shares Outstanding
$18.2m
$ 8.7m
100m
14,054,036
Analyst Coverage
▪ Cantor Fitzgerald (Louise Chen)
▪ HC Wainwright ( Vernon Bernadino)
▪ ROTH Capital (Jonathan Aschoff )
▪ Maxim Group (Jason MacCarthy)
▪ Northland Securities (Carl Byrnes)
29
Senior Management
Hasan Jafri
Chief Medical Officer
(AstraZeneca/Medimmune)
Vu Truong
CEO, Director
(Medimmune, Aviron)
Fred Kurland
Chief Financial Officer
(XOMA, PDL, Aviron)
Steve Chamow
VP, Development
(Genentech, Abgenix)
Elizabeth Leininger
VP, Regulatory & Quality
(FDA, GSK, Chiron/Novartis)
Franco Merckling
SVP, Operations
(Eli Lilly, Eisai, Merck)
30
Board of Directors
Eric Patzer, Ph.D.
Chairman
(Co-Founder, Aridis)
Robert Ruffolo, Ph.D., D.Sc.
(Former President Wyeth/Pfizer)
Craig Gibbs, Ph.D., M.B.A.
(Commercial Gilead; Genentech)
Vu Truong, Ph.D.
(CEO, Aridis)
Susan Windham-Bannister, Ph.D.
(Assoc. Women in STEM, Mass. Life Sci. Ctr)
John Hamilton, M.B.A.
(CFO, Depomed; BioMarin)

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Aridis Investor Presentation 2022 Q1

  • 1. 1 Innovative Therapeutics For Respiratory Health Investor Presentation 1Q-2022
  • 2. 2 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: 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. * * 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. 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. 3 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 clinical data in patients, supporting safety & efficacy Near-term clinical data readouts in three (3) clinical programs [within 9-12 months] Seasoned management team
  • 4. 4 Employing Human Monoclonal Antibody for Infections mAb Toxins Monoclonal Antibody (mAb) Antibiotics Virus Bacteria Benefits of mAbs: Targeted, Durability of action, Predictable safety
  • 5. 5 Product Pipeline Next Milestone Targets IND Phase 1 Phase 2 Phase 3 Products Pre-Clinical Phase 3 data 2H2022 AR-301 mAb (tosotoxumab) Gram (+) Bacteria S. aureus a -toxin Pneumonia Treatment Phase 3 Global launch 1H2022 AR-320 mAb (suvratoxumab) Gram (+) Bacteria S. aureus a-toxin Pneumonia Prevention AR-501 (Panaecin) Gram (-) & (+) Iron Pathways Phase 2a data 1H2022 Cystic Fibrosis AR-701 mAb COVID-19 Virus Spike Protein Phase 1/2a 1H2022 COVID-19 tbd Gram (-) Bacteria A. baumannii AR-401 mAb Bacteremia
  • 6. 6 Healthcare Burden of S. aureus Bacterial Infections ~252,000 ICU patients US claims database (2018)* Survey of 30 cases (median) n=201 Hospital Days n=394 In-Patient Costs Hospital Pharmacy Laboratory 44.4% 21.0% 16.3% 60 days $220,000 37.9 40 days Respiratory Treatment (Mech. ventilation) Radiology (+CT Scans) Cardiology 9.3% 3.3% 1.9% $110,000 20 days 7.2 Operating Room Diagnostics (Blood ECG) 1.4% 1.9% Control Staph Control Staph Pulmonary Diagnostic Orthopeadic 0.4% 0.3% ICU stay 1.1 day 6.9 days 1.1 day 6.9 days All Cause Mortality 3% 16% 3% 16% Restrepo (2010) ICHE 31:509-515 *Kyaw MH et al., 2015 BMC Health Serv Res. 15:241 $146,978 $33,851
  • 7. 7 $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 of Strains 52% 48% Potential S. aureus HAP/VAP Patients by Market1 *Sources 337,500 1 2 Paling FP, BMC Infect Dis. 2017;17(1):643 Francois, B. et al. Lancet Inf. Dis. 2021; https://doi.org/10.1016/S1473-3099(20)30995-6 Warren DK, Outcome and Attributable Cost of VAP among ICU patients in a suburban medical center, Critical Care Med 2003;31(5):1312-7. 3 Lifecycle opportunities include surgical site, skin/skin structure, UTI, and BSI infections due to S. aureus U.S.A. 222,750 Europe Japan 87,750 MRSA MSSA
  • 8. 8 AR-301 & AR-320 Mechanism of Action: Interstitium Normal Alveolus Alveolar air space TargetsS. aureus α-Toxin Type 1 cells Staphyllococcus aureus Macrophages α-toxins Anti-toxin monoclonal antibody approach is a proven MOA, e.g. mAb PMN Necrosis α-toxins attacking immune cell Commercialized: α-toxins Intact immune cell C. Difficile mAb Bezotoxumab (MRK) Anthrax mAb Raxibacumab (GSK- EBSI) Gram (+) bacteria: S. aureus Host cells killed by α-toxins* T-cells Pneumoncytes Endothelial cells Red blood cells Neutrophils Macrophages, Monocytes *Toxins 2013, 5(6), 1140-1166
  • 9. 9 AR-320 (suvratoxumab) Prevention of acute pneumonia in S. aureus colonized, mechanically ventilated ICU patients
  • 10. 10 5,000 mg 750 mg AR-320: Favorable Phase 1 & 2 PK and Safety Data Exceptionally long plasma half-life (T1/2 of 80 to 112 days) Phase 1 Healthy Adults (n=36) Few adverse events (AEs) deemed related to AR-320 Suvratoxumab demonstrated a favorable safety Half-life extension resulted in exceptionally long exposure, up to one (1) year post-dose 10,000 1,000 100 10 Phase 2 ICU S. aureus Colonized Patients (n=196) Adverse events (AEs) , SAEs, deaths were balanced between Placebo and AR-320 Suvratoxumab demonstrated a favorable safety, PK, and ADA profile 1 360 300 0 60 120 180 240 Time since start of infusion (days) Mean Serum Concentration (ug/mL)
  • 11. 11 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 pneumonia ▪ Primary endpoint: Incidence of S. aureus pneumonia* within 30 days post-IV dose (FDA & EMA-negotiated endpoint) Placebo IV infusion n = 100 30-Day Incidence of S. aureus pneumonia* S. aureus colonization confirmation by PCR, randomize & dose n = 96 AR-320 at 5,000mg IV infusion *Adjudicated by panel of VAP experts & radiologists who are blinded to the treatment assignment
  • 12. 12 AR-320 Phase 2: Attained Statistical Significance ( < 65yrs old) Pre-Specified Groups All subjects Low S. aureus (mITT) <65 yrs old 5 VAP bundles** burden 10 n =196 n =128 n =101 n =72 0 -10 -20 -30 -40 -50 -60 (Phase 3 Target Population) -70 p-value 0.069 -80 *p-value < 0.10 is statistically significant per agreement with FDA & EMA, and allowed per FDA Guidance for VAP indication (see FDA Guidance for HAP/VAP, 2013) **5 VAP Bundles is a clinical outcome improvement assessment (elevation of the head of the bed, daily 'sedation vacation' & daily assessment of readiness to extubate, etc.) See Francois, B. et al. 2021 Lancet Infectious Diseases ‘mITT’ is microbiological confirmed intend to treat population Relative Risk Reduction of S.aureus Pneumonia Compared to Placebo (%) p-value 0.166 p-value p-value 0.075* 0.075*
  • 13. 13 Net Difference compared to Placebo 40 Hospitalization days Mechanical ventilationdays ICU days 35 0 -1 -3 -5 -7 -9 -11 30 25 1.9 days 20 15 10 8.8 days Hospitalization days ICU days Mechanical ventilationdays Placebo AR-320 Healthcare Utilization (Mean days) 3.3 days 30.3 20.0 16.7 14.6 12.7 Healthcare Utilization (Mean days) 39.1 AR-320 Phase 2: Pharmacoeconmic outcomes for the Phase 3 target population (<65 yrs old)
  • 14. 14 AR-320 Phase 3 ‘SAATELLITE-2’ Trial Design IV infusion n = 282 30-Day Incidence of all- cause pneumonia* S.a. colonization confirmation by PCR, randomize & dose Evaluating the potential of AR-320 (5,000 mg) to prevent S. aureus pneumonia vs. placebo Single confirmatory Phase 3 prior to BLA Interim futility analysis in mid-2023 and final data readout in 1H2024 n = 282 AR-320 at 5,000mg IV infusion *n=564 translates to ~99% power to achieve p<0.05 for the primary endpoint of All-cause Pneumonia. For secondary endpoint of All-cause Pneumonia or Death, 564 translates to a power of 90% 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 200 sites in ~20 countries (U.S., EU, Asia)
  • 15. 15 AR-301 (tosatoxumab) Treatment of S. aureus ventilator associated pneumonia
  • 16. 16 AR-301: Therapeutic Treatment of Acute Pneumonia Superiority Trial Design VS. AR-301 Standard of Care Standard of Care With positive data, provides for value-based premium reimbursement Antibiotics alone Adjunct therapy
  • 17. 17 AR-301 Phase 2a: Trial Recently Completed Randomized, double-blind, placebo-controlled, single ascending dose of AR-301 31 sites across EU and U.S. Design Patient Selection 48 patients with HAP or VAP caused by S. aureus Groups SOC [antibiotics alone] + Placebo n=16 n= 6 n= 8 n=10 n= 8 SOC + AR-301 SOC + AR-301 SOC + AR-301 SOC + AR-301 (1 mg/kg ) (3 mg/kg) (10 mg/kg) (20 mg/kg) Safety and pharmacokinetics Primary Endpoint Hospitalization days All-cause mortality Clinical cure rate Secondary Endpoint Time to removal of ventilator (VAP patients) Microbiological cure Shorter time to eradication Days in ICU Data trend in favor of adjunctive treatment benefit Francois, B. et al. 2018 Intensive Care Medicine
  • 18. 18 Phase 2 Aggregated AR-301 treated VAP groups exhibited lower probability of requiring mechanical ventilation vs. placebo. Francois, B. et al. 2018 Intensive Care Medicine. Probability of Receiving Mechanical Ventilation 100% 80% 60% 40% 20% 0 5 10 15 20 25 Days on Mechanical Ventilators improvement +AR-301 Pooled (n=20) Antibiotics alone (n=5) 50% AR-301 Phase 2 Efficacy: Time on Mech. Ventilation
  • 19. 19 1-to-1 randomized, double-blind, placebo-controlled, single dose I.V. Evaluating the potential of adjunctive AR-301 (20 mg/kg) to SOC antibiotics vs. antibiotics alone Targeting 240* patients with VAP caused by S. aureus across 125 sites in 20 countries (U.S., EU, Asia) Broad spectrum antibiotics n = 120 Day 21 Test of Clinical Cure** Randomize & Treat n = 120 Broad spectrum antibiotics AR-301 at 20 mg/kg IV infusion Top-line data expected 2H2022 **Sample size at 90% power (p<0.05) [20% absolute effect size]: n=138 *Dependent on extent of COVID-19 related ICU utilization AR-301 Phase 3 (on-going): Trial Design (ClinicalTrials.gov ID NCT03027609) Primary endpoint of clinical cure rate at day 21 Placebo buffer IV infusion
  • 20. 20 AR-301 Phase 3: Powering Calculation and Assumptions Primary Endpoint: Clinical Cure Rate Study Power 80% 90% Control (SOC) AR-301 + SOC Absolute Difference mITT per group Total Enrolled (p<0.05) 75% 75% 95% 95% 20% 20% n = 55 n = 69 n = 110 n = 138 Phase 3 enrollment target = 240 patients* (i.e. over-powered versus n=138 patients to achieve superiority in primary endpoint) *Dependent on extent of COVID-19 related ICU utilization ‘mITT’ is microbiologically confirmed intent to treat population
  • 21. 21 Covering Prevention and Treatment of S.a. HAP/VAP Projecting $1Bn+ market opportunity for each candidate AR-320 Suvratoxumab Prevention Lung colonized, high risk but does not yet have VAP AR-301 Tosatoxumab Treatment Confirmed infection ventilator-assoc. pneumonia *Assumptions: MRSA-only VAP, 60% adoption rate due to first-line, $10,000 per regimen **S. aureus colonized, intubated, without VAP symptoms, $5,000 per regimen, 15% adoption rate Total Sales ($millions) AR- 320 $2,500 Total $2,000 $1,500 AR-301* $1,000 AR-320** AR-301 approval $500 approval $0 2022 2024 2026 2028 2030 2032 2034 2036 2038
  • 22. 22 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
  • 23. 23 AR-501 Phase 1/2: Healthy & Cystic Fibrosis Patients CF Foundation Funded Phase 1 Healthy Volunteers Phase 2 Cystic Fibrosis Patients (on-going) PARI eFlow nebulizer Done Single Ascending Dose 6 mg 20 mg 40 mg Multiple Ascending Doses t = 0, 1, 2 weeks 18 patients AR-501 6 patients Placebo 6 mg 20 mg 40 mg Primary Endpoint: Safety and PK Secondary Endpoints: Lung function of CF patients (changes in FEV1) Sputum bacteriology 30 patients AR-501 15 patients Placebo Done Multiple Ascending Doses t = 0, 1, 2, 3, 4 weeks 6 mg 20 mg 40 mg Ph2a data readout: mid-22 18 patients AR-501 6 patients Placebo Ph1 study results: AR-501 was well tolerated
  • 24. 24 A single IV dose of gallium resulted in statistical significant improvement in lung infection Proxy Data: Safety & Efficacy of IV Gallium Demonstrated Intent to Treat Population CF Patients 10% 8% 6% 4% 2% 0% -2% -4% -6% Inhaled Delivery mg/mL Gallium 300 1 Day 6 Days 14 Days 28 Days 56 Days Gallium Placebo 60 59 60 57 58 57 Patients 60 56 Patients 59 56 Patients Patients Patients 2 Data from University of Washington: Goss, C. et al. 2018 N. Am. Cystic Fibrosis Conference Abstract #307 (*estimate based on animal PK data) Mean Relative Change from Baseline in FEV1 (L) Sputum concentration Inhaled (est.) IV
  • 25. 25 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 & hamster challenge models – Intramuscular and Inhaled formulation options – Long-acting, mAbs are half-life extended – Targeting non-hospitalized COVID population with self-administered, at- home treatment – Phase 1/2 data in 2H2022 Self-administered inhaled formulation option
  • 26. 26 Key Milestones: Multiple clinical data readouts in 2022 2023 2022 Q1 Q4 Q3 Q3 Q4 Q1 Q2 Q2 Phase 3 Data AR-301 Toxin Blocker AR-320 Toxin Blocker Phase 3 Initiation AR-501 Cystic Fibrosis Phase 2a Data Phase 2/3 Data AR-701 COVID-19 Phase 1/2 Data
  • 27. 27 lPEXTM Monoclonal Antibody Discovery & Production Platform Technology CRISPR Guided Integration Convalescent COVID-19 patient PEXTM Nanoarrays B-cell repertoire screening B-cell Selected Cloned CDRs or H&L of IgG’s B.R.E.A.T.H. TM CHO cell line GMP Manufacturing PEXTM Discovery, Development, and Manuf. 12-15 months potential time saving TRADITIONAL: Discovery, Development, and Manufacturing 0 3 6 9 12 15 18 21 24 27 Months Y Y
  • 28. 28 Financial Information As of 9/30/2021 ▪ Cash & Cash Equivalents ▪ Q3Burn ▪ Shares Authorized ▪ Shares Outstanding $18.2m $ 8.7m 100m 14,054,036 Analyst Coverage ▪ Cantor Fitzgerald (Louise Chen) ▪ HC Wainwright ( Vernon Bernadino) ▪ ROTH Capital (Jonathan Aschoff ) ▪ Maxim Group (Jason MacCarthy) ▪ Northland Securities (Carl Byrnes)
  • 29. 29 Senior Management Hasan Jafri Chief Medical Officer (AstraZeneca/Medimmune) Vu Truong CEO, Director (Medimmune, Aviron) Fred Kurland Chief Financial Officer (XOMA, PDL, Aviron) Steve Chamow VP, Development (Genentech, Abgenix) Elizabeth Leininger VP, Regulatory & Quality (FDA, GSK, Chiron/Novartis) Franco Merckling SVP, Operations (Eli Lilly, Eisai, Merck)
  • 30. 30 Board of Directors Eric Patzer, Ph.D. Chairman (Co-Founder, Aridis) Robert Ruffolo, Ph.D., D.Sc. (Former President Wyeth/Pfizer) Craig Gibbs, Ph.D., M.B.A. (Commercial Gilead; Genentech) Vu Truong, Ph.D. (CEO, Aridis) Susan Windham-Bannister, Ph.D. (Assoc. Women in STEM, Mass. Life Sci. Ctr) John Hamilton, M.B.A. (CFO, Depomed; BioMarin)