SAN JOSE, Calif., May 14, 2019 /PRNewswire/ -- Aridis
Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical
company focused on the discovery and development of targeted
immunotherapies using fully human monoclonal antibodies (mAbs) to
treat life-threatening bacterial infections, today reported
financial and corporate results for the first quarter
ended March 31, 2019.
First Quarter Highlights
- Completed enrollment of global Phase 2 clinical trial of AR-105
as a treatment for ventilator-associated pneumonia (VAP) caused by
Pseudomonas aeruginosa (P. aeruginosa). Topline data
expected in Q3 2019
- Initiated Phase 3 global clinical trial of AR-301 targeting
gram-positive Staphylococcus aureus (S. aureus) in
critically ill VAP patients. Interim data expected in Q1 2020 and
top line data expected in late 2020
- Continued enrolling patients at a predicted rate in the Phase
1/2a clinical trial of AR-501, an inhalable therapy to treat
chronic lung infections impacting cystic fibrosis patients.
Top-line data expected in Q1 2020
- Filed for Orphan Drug Designation for AR-105 and AR-501 in U.S.
and Europe
"I'm extremely pleased with the progress achieved during the
quarter highlighted by reaching the enrollment completion milestone
for AR-105's multi-national Phase 2 clinical trial. This is
potentially a landmark study which accesses the clinical utility of
using a targeted immunotherapy to treat a life threatening
bacterial infection. We continue to be on track for a number of
clinical data readouts, starting in the 3rd quarter of
this year with AR-105, and in the 1st quarter of next
year for AR-301 and AR-501," commented Vu
Truong, Ph.D., Chief Executive Officer of Aridis
Pharmaceuticals.
AR-105: The Company is pleased to
report that during the first quarter, the enrollment for the
program's global Phase 2 study was completed. AR-105 is a broadly
active, fully human IgG1 monoclonal antibody targeting VAP caused
by gram-negative P. aeruginosa. The trial enrolled 158
patients and the Company expects to have top-line data from the
study in the third quarter of 2019. Details of the study can
be viewed on www.clinicaltrials.gov using identifier
NCT03027609.
During the quarter, Aridis also filed for Orphan Drug
Designation for AR-105 in U.S. and Europe. In the U.S.,
the FDA Office of Orphan Products Development grants
orphan drug designation to drugs and biologics which are intended
for the treatment, diagnosis or prevention of rare
diseases/disorders that affect fewer than 200,000 people in the
U.S., and may provide grant funding toward clinical trial costs,
tax advantages, FDA user-fee benefits, and seven years of
market exclusivity in the U.S. In Europe, orphan designation is also a status
assigned to a therapy intended for use in rare diseases. To be
granted orphan status by the European Medicines Agency (EMA), the
medicine must be intended for the treatment, prevention or
diagnosis of a disease that is seriously debilitating and/or life
threatening and has a prevalence of up to five in 10,000 in the
European Union. Additionally, the intended medicine must aim to
provide significant benefit to those affected by the condition.
AR-105 has the potential to treat all patient populations
infected by P. aeruginosa and is not limited to any
subset of P. aeruginosa infected patients. Therefore,
pending the outcome of the Phase 2 trial, Aridis will evaluate
whether there is a need to embark on a separate Phase 2/3 clinical
trial for AR-101, another pipeline product which is a highly
specific monoclonal antibody targeting P.
aeruginosa lipopolysaccharide serotype O11 that accounts
for a subset of approximately 22% of all P.
aeruginosa hospital-acquired infections worldwide.
AR-301: During the first quarter, a key
development milestone for the program was the initiation of a Phase
3 global clinical trial targeting gram-positive S. aureus in
critically ill VAP patients. The trial will enroll 240 patients at
approximately 140 clinical centers in 20 countries. Participating
centers in all countries will follow the same stringent clinical
protocols and procedures for critically ill VAP patients, as is
standard in the U.S. and Europe.
The Investigational New Drug (IND) application to include
China among the patient enrolling
countries in the study was accepted by the Chinese FDA. Interim
data is expected in Q1 2020 and top line data expected in late
2020.
AR-301 is an intravenous, broadly active, fully human monoclonal
IgG1 antibody, specifically targeting gram-positive S.
aureus alpha-toxin. It has been shown in vitro to protect
against alpha-toxin mediated destruction of host cells, thereby
potentially preserving the human immune response. AR-301's mode of
action is independent of the antibiotic resistance profile
of S. aureus and it is active against infections
caused by both MRSA (methicillin resistant S. aureus)
and MSSA (methicillin sensitive S. aureus). The trial
represents the first ever Phase 3 superiority clinical study
evaluating immunotherapy with a fully human monoclonal antibody to
treat acute pneumonia in the intensive care unit (ICU) setting.
Details of the study can be viewed on www.clinicaltrials.gov using
identifier NCT03816956.
AR-501: During the first quarter,
Aridis continued enrolling patients in its Phase 1/2a clinical
trial of this inhalable formulation of gallium citrate being
evaluated to treat chronic lung infections associated with cystic
fibrosis with top-line data expected in Q1 2020. AR-501 is being
developed in collaboration with the Cystic Fibrosis Foundation (CF
Foundation) and has been granted by the FDA both Fast Track and
Qualified Infectious Disease Product (QIDP) designations. The Fast
Track designation provides the opportunity to accelerate AR-501's
clinical development as it enables more frequent interactions with
the FDA while also offering potential eligibility for priority
review at the time of license application. The QIDP designation
grants a five-year market exclusivity extension and provides
priority review for the first application submitted for product
approval.
Details of the Phase 1/2a clinical trial, which is a randomized,
double-blinded, placebo controlled single and multiple
dose-ascending trial investigating the safety and pharmacokinetics
of inhaled AR-501 in healthy volunteers and cystic fibrosis
patients with chronic bacterial lung infections, can be viewed on
www.clinicaltrials.gov using identifier NCT03669614. The study will
accrue 48 healthy adult volunteers and 48 cystic fibrosis patients
from approximately 15 sites in the U.S. During the quarter, Aridis
also filed for Orphan Drug Designation for AR-501 in U.S. and
Europe.
Fiscal First Quarter Results: $16.3
million in cash and cash equivalents as of March 31, 2019 with sufficient capital to fund
operations into first quarter 2020
"Our expenses, and the resulting cash burn during the first
quarter, were largely due to costs associated with launching the
Phase 3 study of AR-301 and the Phase 1/2 study of AR-501. These
studies' start-up phases have been largely completed, and we
maintain our forecast of cash into the first quarter of 2020,"
commented Fred Kurland, Aridis'
Chief Financial Officer.
- Revenues: Total revenues for the quarter ended
March 31, 2019 were $1.0 million, an increase of $0.7 million over the similar period in 2018
primarily due to the adoption of ASC 606 and the recognition of an
additional milestone related to the grant from the CF
Foundation.
- Research and Development Expenses: Research and
development expenses for the quarter ended March 31, 2019 were $7.1
million, an increase of $0.5
million over the similar period in 2018 due primarily to an
increase in spending on clinical trial activities and drug
manufacturing for our AR-301 program, partially offset by decrease
in spending on drug manufacturing for our AR-105 program and a
decrease in spending on toxicology studies related to our AR-501
program.
- General and Administrative Expenses: General and
administrative expenses for the quarter ended March 31, 2019 were $1.6
million, an increase of $0.6
million over the similar period in 2018 due primarily to an
increase in directors' and officers' liabilities insurance expense,
an increase in Delaware franchise
taxes, and increases in both personnel related expenses and
professional service fees.
- Interest and Other Income, net: Interest and other
income, net for the quarter ended March 31,
2019 was $116,000, an increase
of approximately $42,000 over the
similar period in 2018. These increases were due primarily to a
higher rate of return on our cash balance partially offset by a
lower average cash balance.
- Change in Fair Value of Warrant Liability: As a
result of all warrants to purchase preferred stock being converted
into warrants to purchase common stock upon our IPO in August 2018, there was no warrant liability
recorded in the first quarter of 2019. There was a $38,000 increase in the fair value of warrant
liability in the quarter ended March 31,
2018.
- Net Loss: The net loss available to common
shareholders for the quarter ended March 31,
2019 was $8.1 million, or
($0.99) per share, compared to a net
loss available to common shareholders of $8.2 million, or ($48.99) per share, for quarter ended
March 31, 2018. It should be noted
that there were 166,373 common shares outstanding during the first
quarter of 2018 and until the completion of the Company's IPO in
August 2018. Moreover, there were
convertible preferred shares outstanding until the time of the IPO
which earned dividends that were distributed as additional shares
of preferred stock. All preferred shares were converted to common
stock upon the completion of the IPO on August 16, 2018. There were 8.1 million common
shares outstanding after the completion of the IPO when all
preferred shares were converted to common shares. At December 31, 2018 and at March 31, 2019, there were 8.1 million shares
common shares outstanding.
About Aridis Pharmaceuticals, Inc.
Aridis Pharmaceuticals, Inc. discovers and develops
anti-infectives to be used as add-on treatments to standard-of-care
antibiotics. The Company is utilizing its proprietary MabIgX®
technology platform to rapidly identify rare, potent
antibody-producing B-cells from patients who have successfully
overcome an infection to produce mAbs. These mAbs are already of
human origin and functionally optimized for high potency by the
donor's immune system, hence they do not require genetic
engineering or further optimization to achieve full functionality
and high mAb productivity. MabIgX® also allows for the selection of
any antibody isotype depending on the optimal effector function
required for treating the target infection. By bypassing the
humanization and binding sequence optimization steps, and the
entire process of generation of genetically engineered antibody
producing cell lines, MabIgX® enables high gross-margins and
expedited progression to clinical development.
The Company has generated multiple clinical stage mAbs targeting
bacteria that that cause life-threatening infections such as
ventilator associated pneumonia (VAP) and hospital acquired
pneumonia (HAP). The use of mAbs as anti-infective treatments
represents an innovative therapeutic approach that harnesses the
human immune system to fight infections and is designed to overcome
the deficiencies associated with the current standard of care which
is broad spectrum antibiotics. Such deficiencies include, but are
not limited to, increasing drug resistance, short duration of
efficacy, disruption of the normal flora of the human microbiome,
and lack of differentiation among current treatments. The mAb
portfolio is complemented by a non-antibiotic novel mechanism small
molecule anti-infective candidate being developed to treat lung
infections in cystic fibrosis patients. The company's pipeline is
highlighted below:
Aridis' Pipeline
AR-301 (ventilator associated
pneumonia). AR-301 is a fully human immunoglobulin 1, or IgG1,
mAb currently in Phase 3 clinical development targeting
gram-positive S. aureus alpha-toxin in
ventilator-associated pneumonia, or VAP, patients.
AR-105 (ventilator associated
pneumonia). AR-105 is a fully human IgG1 mAb targeting
gram-negative P. aeruginosa alginate in
VAP patients. AR-105 is currently being evaluated in a global
Phase 2 clinical study.
AR-101 (hospital acquired pneumonia). AR-101 is
a fully human immunoglobulin M, or IgM, mAb targeting P.
aeruginosa liposaccharides serotype O11, which accounts
for approximately 22% of all P.
aeruginosa hospital acquired pneumonia cases worldwide. A
plan for the next clinical study will be communicated following the
availability of Phase 2 clinical data for AR-105.
AR-501 (cystic fibrosis). AR-501 is an inhaled
formulation of gallium citrate with broad-spectrum anti-infective
activity being developed to treat chronic lung infections in cystic
fibrosis patients. This program is currently in a Phase 1/2a
clinical study in healthy volunteers and CF patients.
AR-401 (blood stream infections). AR-401 is a
fully human mAb preclinical program aimed at treating infections
caused by gram-negative Acinetobacter baumannii.
AR-201 (RSV infection). AR-201 is a fully human IgG1
mAb preclinical program aimed at neutralizing diverse clinical
isolates of respiratory syncytial virus (RSV).
For additional information on Aridis Pharmaceuticals, please
visit https://aridispharma.com/.
Forward-Looking Statements
Certain statements in this press release are forward-looking
statements that involve a number of risks and uncertainties.
These statements may be identified by the use of words such as
"anticipate," "believe," "forecast," "estimated" and "intend" or
other similar terms or expressions that concern Aridis'
expectations, strategy, plans or intentions. These forward-looking
statements are based on Aridis' current expectations and actual
results could differ materially. There are a number of
factors that could cause actual events to differ materially from
those indicated by such forward-looking statements. These
factors include, but are not limited to, the timing of regulatory
submissions, Aridis' ability to obtain and maintain regulatory
approval of its existing product candidates and any other product
candidates it may develop, approvals for clinical trials may be
delayed or withheld by regulatory agencies, risks relating to the
timing and costs of clinical trials, risks associated with
obtaining funding from third parties, management and employee
operations and execution risks, loss of key personnel, competition,
risks related to market acceptance of products, intellectual
property risks, risks associated with the uncertainty of future
financial results, Aridis' ability to attract collaborators and
partners and risks associated with Aridis' reliance on third party
organizations. While the list of factors presented here is
considered representative, no such list should be considered to be
a complete statement of all potential risks and uncertainties.
Unlisted factors may present significant additional obstacles to
the realization of forward-looking statements. Actual results could
differ materially from those described or implied by such
forward-looking statements as a result of various important
factors, including, without limitation, market conditions and the
factors described under the caption "Risk Factors" in Aridis' 10-K
for the year ended December 31,
2018 and Aridis' other filings made with the Securities and
Exchange Commission. Forward-looking statements included
herein are made as of the date hereof, and Aridis does not
undertake any obligation to update publicly such statements to
reflect subsequent events or circumstances.
|
Aridis
Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheets
|
(in
thousands)
|
|
March 31,
|
|
December
31,
|
|
2019
|
|
2018
|
|
(unaudited)
|
|
|
Cash and cash
equivalents
|
$
16,311
|
|
$
24,237
|
Other current and
noncurrent assets
|
6,939
|
|
7,374
|
Total
Assets
|
$
23,250
|
|
$
31,611
|
Total
Liabilities
|
$
4,541
|
|
$
5,297
|
Total stockholders'
equity
|
18,709
|
|
26,314
|
Total liabilities and
stockholders' equity
|
$
23,250
|
|
$
31,611
|
|
|
|
|
|
|
|
|
|
Aridis
Pharmaceuticals, Inc.
|
Condensed
Consolidated Statements of Operation
|
(in thousands, except
share and per share amounts)
|
|
|
|
|
|
Three Months
Ended
|
|
March 31,
|
|
(unaudited)
|
|
2019
|
|
2018
|
Revenue
|
$
1,022
|
|
$
322
|
|
|
|
|
Operating
Expenses*
|
|
|
|
Research and
development
|
7,118
|
|
6,626
|
General and
administrative
|
1,641
|
|
1,066
|
Total operating
expenses
|
8,759
|
|
7,692
|
|
|
|
|
Loss from
operations
|
(7,737)
|
|
(7,370)
|
Other income
(expense)
|
|
|
|
Interest and other
income (expense), net
|
116
|
|
74
|
Change in fair value
of warrant liability
|
-
|
|
(38)
|
Equity in net loss
from equity method investment
|
(442)
|
|
-
|
|
|
|
|
Net loss
|
$
(8,063)
|
|
$
(7,334)
|
Preferred
dividends
|
$
-
|
|
$
(817)
|
Net loss available to
common stockholders
|
$
(8,063)
|
|
$
(8,151)
|
|
|
|
|
Weighted-average
common shares outstanding, basic and diluted
|
8,105,636
|
|
166,373
|
|
|
|
|
Net loss per common
share, basic and diluted
|
$
(0.99)
|
|
$
(44.08)
|
Preferred dividends,
basic and diluted
|
$
-
|
|
$
(4.91)
|
Net loss per share
available to common stockholders, basic and diluted
|
$
(0.99)
|
|
$
(48.99)
|
|
|
|
|
*Includes stock
based-compensation as follows
|
|
|
|
Research and
development
|
$
173
|
|
$
141
|
General and
administrative
|
277
|
|
362
|
|
$
450
|
|
$
503
|
Contact:
Investor Relations
Jason Wong
Blueprint Life Science Group
jwong@bplifescience.com
(415) 375-3340 Ext. 4
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SOURCE Aridis Pharmaceuticals, Inc.