SAN JOSE, Calif., Aug. 12, 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 second quarter
ended June 30, 2019.
Second Quarter Highlights and Recent Developments
- Remained on schedule to report top line data in Q3 2019 for
AR-105's global Phase 2 clinical trial for the treatment of
ventilator-associated pneumonia (VAP) caused by Pseudomonas
aeruginosa (P. aeruginosa).
- Received Orphan Drug designation from the U.S. Food and Drug
Administration (FDA) and The European Medicines Agency (EMA) for
AR-501, an inhalable therapy being clinically tested for the
treatment of chronic lung infections in cystic fibrosis
patients.
- Received Qualified Infectious Diseases Product (QIDP) and
Fast-Track designations from the FDA for AR-501.
- Maintained enrollment pace of AR-501's Phase 1/2a clinical
trial with top-line data from healthy subjects expected towards the
end of Q1 2020 and from cystic fibrosis patients in Q2 2021.
- Advanced Phase 3 global clinical trial of AR-301 targeting
gram-positive Staphylococcus aureus (S. aureus) in
critically ill VAP patients. Remained on track to report interim
data in Q1 2020 with top line data expected in late 2020.
- Bolstered leadership team with appointment of Dr. Susan Windham-Bannister to Board of
Directors.
- Announced the execution of a $10
million equity purchase transaction at a premium of
approximately 31% and entered into an option agreement with Serum
International B.V. ("SIBV"), an affiliate of the Serum Institute of
India Private Limited ("SIIL"), for exclusive rights to license
products and mAb discovery platform technology MabIgX®.
- Received an upfront cash payment of $5
million upon execution of the option agreement with SIBV and
will receive an additional $10
million upon execution of the license agreement by
August 31, 2019.
"The second quarter proved to be a significant period of growth
for the company," commented Vu
Truong, Ph.D., Chief Executive Officer of Aridis
Pharmaceuticals. "In addition to maintaining the development
pace of our clinical programs, I am very pleased with the work
performed by the entire team as we evaluated and ultimately brought
on SIBV as a shareholder and potentially a commercial partner for
certain ex-U.S. and ex-EU markets. SBIV's parent company, SIIL, is
a bona fide leader in vaccines and biologics that has in recent
years acquired formidable capabilities in monoclonal antibody
development and manufacturing. I am particularly pleased that the
option agreement not only includes a selection of our products, but
also provides SIBV access to our ground-breaking MabIgX® platform
for new asset identification and development, which is a testament
to the quality of the technology."
Clinical Program Update
AR-105: The Company is pleased to
report that AR-105's global Phase 2 clinical trial is on
track to report topline data in Q3 2019. The trial,
which was fully enrolled during the first quarter of 2019, consists
of 158 treated patients and is evaluating AR-105, a broadly active,
fully human IgG1 monoclonal antibody for the treatment of VAP
caused by gram-negative P. aeruginosa. Details of the study
can be viewed on www.clinicaltrials.gov using identifier
NCT03027609.
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 second quarter, Aridis
continued enrolling its Phase 3 global clinical trial for AR-301,
which targets gram-positive S. aureus in critically ill VAP
patients. The trial, which was initiated in the first quarter of
2019, is expected to enroll 240 patients at approximately 140
clinical centers in 20 countries. Interim data is expected in Q1
2020 and top line data is expected in late 2020. Participating
centers in all countries are following the same stringent clinical
protocols and procedures for critically ill VAP patients, as is
standard in the U.S. and Europe.
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-301 is a 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).
AR-501: During the second 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. The single ascending dose cohorts of healthy subjects
have completed dosing and the Safety Monitoring Committee has
recommended proceeding into the multiple ascending dose cohorts.
The Company expects to report data from the Phase 1 portion of the
trial which consists of healthy subjects in Q1 2020 and the Phase
2a segment with cystic fibrosis subjects in Q2 2021.
AR-501, which is being developed in collaboration with the
Cystic Fibrosis Foundation, has been granted by the FDA both Fast
Track and QIDP designations. In addition, during the second
quarter, the FDA and recently (July 19,
2019), the EMA granted AR-501 Orphan Drug Designation.
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 is
expected to accrue 48 healthy adult volunteers and 48 cystic
fibrosis patients from approximately 15 sites in the U.S.
Corporate Update and Recent Developments
During the second quarter, the Company enhanced its leadership
team with the appointment of Susan
Windham-Bannister, Ph.D., to its Board of Directors. Dr.
Windham-Bannister, an internationally recognized expert in advising
biopharma companies on market access, growth optimization and
portfolio management strategies, currently serves as President and
CEO of Biomedical Growth Strategies., LLC and Managing Partner of
Biomedical Innovation Advisors, LLC, an advisory firm serving the
healthcare industry which she founded with Dr. Harvey Lodish, co-founder of Genzyme. As Aridis
prepares for multiple data readouts over the course of 2019 and
into the first quarter of next year, Dr. Windham-Bannister's
expertise will be utilized in addressing key areas such as
healthcare policy, drug reimbursement and commercial strategy for
the Company's product candidates.
On July 30, 2019, Aridis announced
that the Company entered into equity purchase and option agreements
with SIBV, the world's largest vaccine manufacturer by dose.
SIBV invested $10 million into
Aridis and received 801,820 shares of the Company's restricted
common stock at a price of approximately $12.47 per share, which represented a premium of
approximately 31% to the closing share price of Aridis common
stock on July 29, 2019.
Pursuant to the option agreement, Aridis received a $5 million upfront payment and will receive an
additional $10 million upon execution
of the license agreement by August 31,
2019. The upfront payment is refundable should the parties
not complete the license agreement. Furthermore, assuming the
license agreement is executed, Aridis expects to receive as much as
$42.5 million in future milestone
payments for achieving product development and commercial
objectives, along with royalties on net sales.
The license agreement will provide SIBV with the right to
in-license Aridis' clinical stage programs AR-301(VAP), AR-105
(VAP) and AR-101 (hospital acquired pneumonia (HAP)). These
license rights will be exclusive and to a limited territory which
includes markets outside of the U.S., Europe, Canada, UK, China, Australia, New
Zealand and Japan. Also,
the agreement will include the option to acquire an exclusive,
worldwide license (excluding China) to AR-201, a preclinical fully human
mAb for the prevention of respiratory syncytial virus (RSV). In
addition, SIBV may elect to collaborate with Aridis to utilize
MabIgX® to identify and advance up to five SIBV wholly-owned
programs. MabIgX® is Aridis' proprietary technology platform to
rapidly identify rare, potent antibody-producing B-cells from
patients who have successfully overcome an infection to produce
mAbs.
Fiscal 2019 Second Quarter Results:
- Cash: Total cash and cash equivalents as of June 30, 2019 was $8.5
million. In July 2019, we
received net proceeds of approximately $9.2
million from the sale of 801,820 shares of restricted common
stock. In addition, the Company received an upfront cash payment of
$5 million upon the execution of an
option agreement. This upfront payment is refundable should the
parties not complete the license agreement by August 31, 2019.
- Revenues: Total revenues for the quarter ended
June 30, 2019 was zero, a decrease of
$22,000 over the same period in
2018.
- Research and Development Expenses: Research and
development expenses for the quarter ended June 30, 2019 were $6.7
million, an increase of $2.8
million over the same period in 2018 due primarily to an
increase in spending on clinical trial activities and drug
manufacturing for our AR-301 program and an increase in spending on
drug manufacturing for our AR-105 Phase 3 program, partially offset
by a decrease in spending on clinical trial activities for our
AR-105 Phase 2 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 June 30, 2019 were $1.6
million, an increase of $0.9
million over the same period in 2018 due primarily to an
increase in professional service fees, an increase in personnel
related expenses, an increase in directors' and officers'
liabilities insurance expense, and an increase in Delaware franchise taxes and patent related
fees.
- Interest and Other Income, net: Interest and other
income, net for the quarter ended June 30,
2019 was $69,000, an increase
of approximately $1,000 over the same
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 at the end of the second quarter of 2019. There was a
$3.1 million gain attributed to a
decrease in the fair value of the warrant liability in the second
quarter of 2018.
- Net Loss: The net loss available to common shareholders
for the quarter ended June 30, 2019
was $8.4 million, or ($1.03) per share, compared to a net loss
available to common shareholders of $2.0
million, or ($11.78) per
share, for the quarter ended June 30,
2018. It should be noted that there were 166,373 common
shares outstanding during the second 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
June 30, 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
VAP and 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 (VAP). 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 VAP patients.
AR-105 (VAP). 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 (HAP). 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)
|
|
|
June
30,
|
|
December
31,
|
|
|
2019
|
|
2018
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
8,519
|
|
$
24,237
|
Other current and
noncurrent assets
|
|
7,355
|
|
7,374
|
Total
Assets
|
|
$
15,874
|
|
$
31,611
|
|
|
|
|
|
Total
Liabilities
|
|
$
5,012
|
|
$
5,297
|
Total stockholders'
equity
|
|
10,862
|
|
26,314
|
Total liabilities and
stockholders' equity
|
|
$
15,874
|
|
$
31,611
|
Aridis
Pharmaceuticals, Inc.
|
Condensed
Consolidated Statements of Operation
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
|
June
30,
|
|
June
30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
(unaudited)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
—
|
|
$
22
|
|
$
1,022
|
|
$
344
|
|
|
|
|
|
|
|
|
|
Operating
Expenses*
|
|
|
|
|
|
|
|
|
Research and
development
|
|
6,653
|
|
3,885
|
|
13,771
|
|
10,511
|
General and
administrative
|
|
1,613
|
|
687
|
|
3,254
|
|
1,753
|
Total operating
expenses
|
|
8,266
|
|
4,572
|
|
17,025
|
|
12,264
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(8,266)
|
|
(4,550)
|
|
(16,003)
|
|
(11,920)
|
Other income
(expense)
|
|
|
|
|
|
|
|
|
Interest and other
income, net
|
|
69
|
|
68
|
|
185
|
|
142
|
Change in fair value
of warrant liability
|
|
—
|
|
3,058
|
|
—
|
|
3,021
|
Equity in net loss
from equity method investment
|
|
(186)
|
|
—
|
|
(628)
|
|
—
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
(8,383)
|
|
$
(1,424)
|
|
$
(16,446)
|
|
$
(8,757)
|
Preferred
dividends
|
|
$
-
|
|
$
(535)
|
|
$
-
|
|
$
(1,352)
|
Net loss available to
common stockholders
|
|
$
(8,383)
|
|
$
(1,959)
|
|
$
(16,446)
|
|
$ (10,109)
|
|
|
|
|
|
|
|
|
|
Weighted-average
common shares outstanding, basic and diluted
|
|
8,107,290
|
|
166,373
|
|
8,106,484
|
|
166,373
|
|
|
|
|
|
|
|
|
|
Net loss per common
share, basic and diluted
|
|
$
(1.03)
|
|
$
(8.56)
|
|
$
(2.03)
|
|
$
(52.63)
|
Preferred dividends,
basic and diluted
|
|
$
—
|
|
$
(3.22)
|
|
$
—
|
|
$
(8.13)
|
Net loss per share
available to common stockholders, basic and diluted
|
|
$
(1.03)
|
|
$
(11.78)
|
|
$
(2.03)
|
|
$
(60.76)
|
|
|
|
|
|
|
|
|
|
*Includes stock
based-compensation as follows
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
198
|
|
$
139
|
|
$
371
|
|
$
280
|
General and
administrative
|
|
305
|
|
179
|
|
549
|
|
509
|
|
|
$
503
|
|
$
318
|
|
$
920
|
|
$
789
|
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.