SAN JOSE, Calif., July 30, 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, announced today that
it has entered into an option agreement with the Serum
International BV ("SIBV"), an affiliate of Serum Institute of
India, Ltd., the world's largest
vaccine manufacturer by dose units. The agreement grants SIBV the
option to license multiple programs from Aridis and access the
Company's MabIgX® platform technology for asset identification and
selection. As part of the option agreement, SIBV made an
equity investment of $10 million
whereby Aridis will issue 801,820 shares of its restricted common
stock to SIBV at a price of approximately $12.47 per share which represents
approximately 31% premium to yesterday's closing share price. In
addition, Aridis received an upfront cash payment of $5 million upon execution of this option
agreement 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, under the license agreement, Aridis
will receive future milestone payments for achieving product
development and commercial objectives, along with royalties on net
sales.
"I am pleased to reach agreement for a comprehensive licensing
relationship with the Serum Institute, who has built formidable
capabilities in monoclonal antibody development and manufacturing
as part of its plan to expand into biotherapeutics and transition
to a major global biotechnology company," commented Vu Truong,
Ph.D., Chief Executive Officer of Aridis Pharmaceuticals.
Under the terms of the agreement, SIBV has the option to
in-license Aridis' clinical stage programs AR-301(ventilator
associated pneumonia), AR-105 (ventilator associated pneumonia),
and AR-101 (hospital acquired pneumonia): these license rights will
be exclusive and to a limited territory, which includes territories
outside of the U.S., Europe,
Canada, UK, China, Australia, New
Zealand and Japan. The
option includes the right 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, under the agreement
SIBV may elect to collaborate with Aridis to utilize MabIgX® to
identify and advance up to 5 wholly-owned programs for the
treatment of infectious diseases of import to the developing world.
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.
"This strategic alliance provides a commercial gateway for our
monoclonal antibody (mAb) immunotherapies to be implemented in
emerging markets, where the Serum Institute has strong commercial
presence. More importantly because our targeted anti-infective
immunotherapies are effective against antibiotic resistant
infections, which are frequently common in developing world and
emerging market countries, this partnership allows for the
introduction of much needed innovative medicines to regions of the
world where antimicrobial resistance is particularly high," said
Dr. Truong.
"We are excited by the potential to establish a multi-faceted
relationship with Aridis as it represents a unique opportunity to
add important assets to our commercial product portfolio while
bolstering our development pipeline," commented Adar C. Poonawalla,
Chief Executive Officer of Serum Institute. "We are encouraged by
the data demonstrated to date by these programs, view the
MabIgX® platform as a promising source for additional pipeline
candidates, and are excited to invest in an anti-infective company
with a novel approach to treating bacterial diseases using fully
human monoclonal antibodies (mAbs)."
About Serum Institute of India, Ltd.
Serum Institute of
India Pvt. Ltd. is the world's largest vaccine manufacturer by
number of doses produced and sold globally (more than 1.3 billion
doses) which includes Polio vaccine as well as Diphtheria, Tetanus,
Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella
vaccines. It is estimated that about 65% of the children in the
world receive at least one vaccine manufactured by Serum Institute.
Vaccines manufactured by the Serum Institute are accredited by the
World Health Organization, Geneva
and are being used in around 170 countries across the globe in
their national immunization programs, saving millions of lives
throughout the world. The Serum Institute also manufactures
and commercializes recombinant protein products such as anti-sera,
monoclonal antibodies, human erythropoietin.
Serum Institute of India is
ranked as India's No. 1
biotechnology company, manufacturing highly specialized life-saving
biologicals using cutting edge genetic and cell-based technologies,
antisera and other medical specialties.
Serum Institute of India was
founded in 1966 by Dr. Cyrus
Poonawalla with the aim of manufacturing life-saving
immuno-biologicals, which were in shortage in the country and
imported at high prices. Thereafter, several life-saving
biologicals were manufactured at prices affordable to the common
man and in abundance, with the result that the country was made
self-sufficient for Tetanus Anti-toxin and Anti-snake Venom serum,
followed by DTP (Diphtheria, Tetanus and Pertussis) group of
Vaccines and then later on MMR (Measles, Mumps and Rubella) group
of vaccines. Additional information is available at the Company's
website at www.seruminstitute.com.
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 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 broad spectrum antibiotics, which is
the current standard of care. 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 liposaccharide 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 currently in preclinical development aimed at
treating infections caused by gram-negative Acinetobacter
baumannii.
AR-201 (RSV infection). AR-201 is a fully human IgG1
mAb currently in preclinical development 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.
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.