SAN JOSE, Calif., Nov. 13, 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 third quarter
ended September 30, 2019.
Third Quarter Highlights and Recent Developments
- Advanced Phase 3 global clinical trial of AR-301 in patients
with ventilator associated pneumonia (VAP) and remain on track to
announce top line data expected in early 2021.
- Executed an equity purchase agreement with Serum Institute BV
(SIBV), an affiliate of the Serum Institute of India, Ltd. (SIIL), whereby SIBV invested
$10 million into Aridis.
- Executed license agreement with Serum AMR (SAMR), another
affiliate of SIIL, for rights to multiple products and utilization
of MabIgX® platform technology (transaction included a $15M upfront payment).
- Received Orphan Drug Designation (ODD) from The European
Medicines Agency (EMA) for AR-501, an inhalable therapy for the
treatment of chronic lung infections in cystic fibrosis
patients.
- Continued enrolling AR-501's Phase 1/2a clinical trial with
top-line data expected in Q1 2020 (healthy subjects), and in Q2
2021 (cystic fibrosis subjects).
- Enhanced leadership team with key appointments including
infectious disease expert, Dr. Paul
Mendelman as Interim Chief Medical Officer.
- Presented posters at the Infectious Disease Society of
America's (IDSA) IDWeek™ 2019 on AR-105 and AR-501.
- Announced results from AR-105's global Phase 2 clinical trial
for the treatment of VAP caused by Pseudomonas aeruginosa (P.
aeruginosa).
"The major emphasis for the period was laying the foundation for
our long-term growth strategy as we head into the final quarter of
2019, and the new year. While we are certainly disappointed by
AR-105's Phase 2 clinical trial result, our intense post-data
analysis gives us conviction that the ongoing phase 3 study for
AR-301 in S. aureus VAP is being conducted with utmost rigor
and scrutiny incorporating lessons learned from AR-105 to bring
this drug to market. Similarly, we remain confident in the design
and execution of the ongoing phase 1/ 2 trial for AR-501 targeting
infections in cystic fibrosis patients," commented Vu Truong, Ph.D., Chief Executive Officer of
Aridis Pharmaceuticals.
"I'm especially pleased with the recent addition to management
of Dr. Paul Mendelman who brings
renowned infectious disease expertise to the team and is already
impacting the data analysis of the AR-105 clinical trial as well as
management of our ongoing Phase 3 clinical trial for AR-301 and
Phase 1/2a clinical trial for AR-501 programs. Moving forward, we
are now well positioned to execute on our clinical development
strategy and to commence in earnest corporate development
activities for the MabIgX® platform," continued Dr. Truong.
Clinical Program Update
AR-301: During the third 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 125 clinical centers in 20 countries. Interim data is
expected in early 2020 and top line data is expected in early 2021.
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 setting. Details of the study can be viewed on
www.clinicaltrials.gov using identifier NCT03816956.
AR-301 is a 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 third quarter,
Aridis continued enrolling patients in its Phase 1/2a clinical
trial of this inhalable formulation of gallium citrate being
evaluated for the treatment of 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 (CFF), has been granted by the U.S. Food
and Drug Administration (FDA) both Fast Track and Qualified
Infectious Disease Product Designation (QIDP) designations. In
addition, during the third quarter (July
19th), the EMA granted the program Orphan Drug
Designation (ODD). The FDA had granted ODD status to AR-501 in
June 2019.
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.
AR-105: During the third quarter
(September 3, 2019), Aridis reported
results for its global Phase 2 clinical trial evaluating
AR-105, a fully human IgG1 monoclonal antibody for the
treatment of VAP caused by gram-negative Pseudomonas
aeruginosa (P. aeruginosa). The completed study did not
meet its primary endpoint of demonstrating superiority in clinical
cure rates on Day 21 compared to placebo. Furthermore,
there was a statistically significant imbalance in all-cause
mortality, as well as serious adverse event (SAE) rates between
treatment groups that favored placebo. However, no SAE or mortality
in the study was deemed to be drug related by the study
investigators or the study's data monitoring committee. AR-105 has
a different mechanism of action, directed at a different bacterium,
and evaluated in a different patient population as compared to
AR-301. While no further development resources will be allocated
towards AR-105, the Company will continue to analyze the full data
set to better understand the top-line results.
Throughout the third quarter, Aridis continued to attend
investor and medical conferences and recently presented two posters
at the Infectious Disease Society of America's (IDSA)
IDWeek™ 2019, which took place on October 2nd-6th in
Washington, DC. Both posters,
"Pre-Clinical and Phase I Safety Data for Anti-Pseudomonas
aeruginosa Human Monoclonal Antibody AR-105," and "In
Vitro and In Vivo Non Clinical Efficacy of AR-501 (Gallium
Citrate)," were presented on October
3, 2019.
Infectious Disease Specialist CMO Appointment: A
recent key highlight occurred on October 11,
2019, when Aridis announced the appointment of Paul Mendelman, MD, as interim Chief Medical
Officer, replacing Dr. Wolfgang
Dummer who departed the company for personal reasons. Dr.
Mendelman brings to Aridis a prolific career in infectious diseases
across industry and academia spanning over 30 years with board
certification in pediatrics and pediatric infectious diseases. He
has held senior clinical development positions at leading companies
such as Takeda Vaccines (Vice President, Medical), MedImmune (Vice
President & Therapeutic Area Leader, Clinical Development), and
Merck (Director, Clinical Research Infectious Diseases). From 1996
to 2005, he managed the clinical development group for FluMist®,
the live attenuated intranasal influenza vaccine, licensed
initially in the U.S. for the 2003-04 season. The Company also
promoted Lynne Deans to the position
of Vice President, Clinical Operations. Ms. Deans has over 30 years
of experience in clinical operations and has held senior director
of clinical operations positions in infectious diseases focused
companies such as Cerexa, PaxVax, and Kalobios.
Corporate Update:
A key highlight during the third quarter was the execution of a
license agreement with SAMR, an affiliate of SIIL. The agreement
provides SAMR 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 includes an exclusive, worldwide license (excluding
China) to AR-201, a preclinical
fully human mAb for the prevention of respiratory syncytial virus
(RSV). In addition, SAMR may elect to collaborate with Aridis to
utilize MabIgX® to identify and advance up to five SAMR
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.
Under the terms of the Agreement, Aridis received a $15M upfront payment and will be eligible 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
consummation of this transaction follows an equity purchase
agreement with SIBV, another affiliate of SIIL, which occurred in
July 2019 whereby SIBV invested
$10 million into Aridis.
"We continued to make major strides in corporate development
with a key pharmaceutical alliance, which also improves our balance
sheet. SIIL is the world's largest vaccine manufacturer by dose
units and a significant monoclonal antibody development and
manufacturing company. This combined product and technology license
is a testament to the quality of our pipeline and groundbreaking
MabIgX® platform for identifying rare, potent
antibody-producing B-cells from patients who have successfully
overcome an infection to produce mAbs," concluded Dr. Truong.
Fiscal 2019 Third Quarter Results:
- Cash: Total cash and cash equivalents as of September 30, 2019 was $17.3 million. In addition, in October 2019 the Company received $10 million, the balance due on the upfront
payment from SAMR upon the execution of license agreement referred
to above.
- Revenues: Total revenues for the quarter ended
September 2019 was zero, a decrease
of $1.0 million over the same period
in 2018 when a $1.0 million milestone
payment was recognized from the CFF associated with its grant to
fund the AR-501 Phase 1/2a clinical trial.
- Research and Development Expenses: Research and
development expenses for the quarter ended September 30, 2019 were $6.0 million, a decrease of $0.9 million over the same period in 2018 due
primarily to a decrease in spending on clinical trial activities
and drug manufacturing for our AR-105 program, which was recently
completed, partially offset by an increase in spending on clinical
trial activities for both our AR-301 Phase 3 and the AR-501 Phase
1/2a programs.
- General and Administrative Expenses: General and
administrative expenses for the quarter ended September 30, 2019 were $1.4 million, an increase of $0.6 million over the same period in 2018 due
primarily to an increase in personnel related expenses, including
stock-based compensation, an increase in patent related fees and an
increase in directors' and officers' liabilities insurance
expense.
- Interest and Other Income, net: Interest and other
income, net for the quarter ended September
30, 2019 was $90,000, a
decrease of $29,000 over the same
period in 2018. This decrease was due primarily to 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 third quarter of 2019. There was a
$1.4 million loss attributed to an
increase in the fair value of the warrant liability in the third
quarter of 2018.
- Net Loss: The net loss available to common shareholders
for the quarter ended September 30,
2019 was $7.6 million, or
($0.87) per share, compared to a net
loss available to common shareholders of $7.9 million, or ($1.97) per share, for the quarter ended
September 30, 2018. It should be
noted that there were 166,373 common shares outstanding during the
third 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. As a result, the weighted
average common shares outstanding for the third quarter of 2018 was
4.0 million. At September 30, 2019,
the weighted average common shares outstanding for the third
quarter of 2019 was 8.7 million.
About Aridis Pharmaceuticals, Inc.
Aridis
Pharmaceuticals, Inc. discovers and develops anti-infectives with
mechanisms of action that are different from 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. 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 product
candidates targeting bacteria that cause life-threatening
infections such as VAP, HAP and chronic lung infections in
cystic fibrosis. 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 as a chronic
inhaled therapy 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-501 (cystic fibrosis). AR-501 is an inhaled
formulation of gallium citrate with broad-spectrum anti-infective
activity being developed as a chronic treatment for lung infections
in cystic fibrosis patients. This program is currently in a
Phase 1/2a clinical study in healthy volunteers and CF
patients.
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.
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)
|
|
|
|
September
30,
|
|
December
31,
|
|
|
2019
|
|
2018
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
17,330
|
|
$
24,237
|
Other current and
noncurrent assets
|
|
17,037
|
|
7,374
|
Total
Assets
|
|
$
34,367
|
|
$
31,611
|
|
|
|
|
|
Total
Liabilities
|
|
$
25,590
|
|
$
5,297
|
Total stockholders'
equity
|
|
8,777
|
|
26,314
|
Total liabilities and
stockholders' equity
|
|
$
34,367
|
|
$
31,611
|
Aridis
Pharmaceuticals, Inc.
|
Condensed
Consolidated Statements of Operation
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
|
September
30,
|
|
September
30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
(unaudited)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
—
|
|
$
1,022
|
|
$
1,022
|
|
$
1,367
|
|
|
|
|
|
|
|
|
|
Operating
Expenses*
|
|
|
|
|
|
|
|
|
Research and
development
|
|
6,011
|
|
6,907
|
|
19,782
|
|
17,418
|
General and
administrative
|
|
1,384
|
|
735
|
|
4,638
|
|
2,489
|
Total operating
expenses
|
|
7,395
|
|
7,642
|
|
24,420
|
|
19,907
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(7,395)
|
|
(6,620)
|
|
(23,398)
|
|
(18,540)
|
Other income
(expense)
|
|
|
|
|
|
|
|
|
Interest and other
income, net
|
|
90
|
|
119
|
|
275
|
|
262
|
Change in fair value
of warrant liability
|
|
—
|
|
(1,388)
|
|
—
|
|
1,632
|
Equity in net loss
from equity method investment
|
|
(282)
|
|
(20)
|
|
(910)
|
|
(20)
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
(7,587)
|
|
$
(7,909)
|
|
$
(24,033)
|
|
$
(16,666)
|
Preferred
dividends
|
|
$
-
|
|
$
(5)
|
|
$
-
|
|
$
(1,357)
|
Net loss available to
common stockholders
|
|
$
(7,587)
|
|
$
(7,914)
|
|
$
(24,033)
|
|
$
(18,023)
|
|
|
|
|
|
|
|
|
|
Weighted-average
common shares outstanding, basic and diluted
|
|
8,694,104
|
|
4,019,459
|
|
8,304,510
|
|
1,469,623
|
|
|
|
|
|
|
|
|
|
Net loss per common
share, basic and diluted
|
|
$
(0.87)
|
|
$
(1.97)
|
|
$
(2.89)
|
|
$
(11.34)
|
Net loss per share
available to common stockholders, basic and diluted
|
|
$
(0.87)
|
|
$
(1.97)
|
|
$
(2.89)
|
|
$
(12.26)
|
|
|
|
|
|
|
|
|
|
*Includes stock
based-compensation as follows
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
168
|
|
$
159
|
|
$
539
|
|
$
439
|
General and
administrative
|
|
351
|
|
235
|
|
900
|
|
745
|
|
|
$
519
|
|
$
394
|
|
$
1,439
|
|
$
1,184
|
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.