ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical
company that develops, manufactures, and intends to market
specialty plasma-based biologics for the treatment and prevention
of certain infectious diseases, today announced that it has
received a $5 million tranche from Hercules Technology Growth
Capital, Inc. (NYSE:HTGC), the leading specialty finance company
focused on providing senior secured loans to venture capital-backed
companies in technology-related markets. The $5 million was
based upon ADMA achieving clinical endpoints of a Phase III
clinical study of RI-002 as a treatment for Primary
Immunodeficiency Disease (PIDD), under its existing loan and
security agreement.
"We are very pleased to have achieved this key, positive Phase
III milestone. We have enjoyed working with the Hercules team,
and receiving this additional $5 million will further strengthen
our current cash position. This funding will supplement and
enhance our commercialization planning, plasma inventory build-up
and will allow for the initiation of staffing for our commercial
infrastructure," stated Adam Grossman, President & CEO.
About ADMA Biologics, Inc.
ADMA is a late stage biopharmaceutical company that develops,
manufactures, and intends to market specialty plasma-based
biologics for the treatment and prevention of certain infectious
diseases. ADMA's mission is to develop and commercialize
plasma-derived, human immune globulins targeted to niche patient
populations for the treatment and prevention of certain infectious
diseases. The target patient populations include immune-compromised
individuals who suffer from an underlying immune deficiency disease
or who may be immune-compromised for medical reasons. For more
information, please visit the Company's website at
www.admabiologics.com.
About ADMA's lead product candidate RI-002
ADMA's lead product candidate, RI-002 is a specialty
plasma-derived, polyclonal, Intravenous Immune Globulin, or IGIV,
derived from human plasma containing naturally occurring polyclonal
antibodies (e.g., Streptococcus pneumoniae, H. influenza type B,
Cytomegalovirus (CMV), measles, tetanus, etc.) as well as
standardized, high levels of antibodies to respiratory syncytial
virus (RSV). ADMA is pursuing an indication for the use of this
specialty IGIV product for treatment of patients diagnosed with
primary immune deficiency diseases, or PIDD. Polyclonal antibodies
are the primary active component of IGIV products. Polyclonal
antibodies are proteins that are used by the body's immune system
to neutralize microbes, such as bacteria and viruses. Preliminary
review indicates that the polyclonal antibodies that are present in
RI-002 support the ability of this product to prevent infections in
immune-compromised patients. Preliminary analysis demonstrated that
the Phase III trial has met the primary endpoint with no serious
bacterial infections (SBI) reported. These results are well below
the requirement specified by FDA guidance of ≤ 1 SBI per
patient-year.
About Hercules Technology Growth Capital,
Inc.
Hercules Technology Growth Capital, Inc. (NYSE:HTGC)
("Hercules") is the leading specialty finance company focused on
providing senior secured loans to venture capital-backed companies
in technology-related markets, including technology, biotechnology,
life science, and energy and renewable technology, at all stages of
development. Since inception (December 2003), Hercules has
committed more than $4.6 billion to over 300 companies and is a
lender of choice for entrepreneurs and venture capital firms
seeking growth capital financing. Companies interested in learning
more about financing opportunities should contact info@htgc.com, or
call 650.289.3060.
Cautionary Statement Regarding Forward-Looking
Information
This press release contains "forward looking statements."
Forward-looking statements include, without limitation, any
statement that may predict, forecast, indicate, or imply future
results, performance or achievements, and may contain the words
"estimate," "project," "intend," "forecast," "target,"
"anticipate," "plan," "planning," "expect," "believe," "will,"
"will likely," "should," "could," "would," "may" or, in each case,
their negative, or words or expressions of similar meaning. These
forward-looking statements include, but are not limited to,
statements concerning timing of availability of final data,
possible characteristics of RI-002, acceptability of RI-002 for any
purpose, results relating to secondary endpoints, final data
relating to RI-002, likelihood and timing of FDA action with
respect to any further filings by the Company, results of the
clinical development, the availability of data, the reporting of
data, regulatory processes, potential clinical trial initiations,
potential investigational new product applications, biologics
license applications, expansion plans, the achievement of clinical
and regulatory milestones, commercialization efforts of the
Company's product candidate(s) and trends relating to demand for
source plasma. Forward-looking statements are subject to many risks
and uncertainties that could cause our actual results and the
timing of certain events to differ materially from any future
results expressed or implied by the forward-looking statements,
including, but not limited to, the risks listed under the heading
"Risk Factors" in our Annual Report on Form 10-K for the year ended
December 31, 2013, as filed with the U.S. Securities and Exchange
Commission on March 28, 2014 and our other filings with the U.S.
Securities and Exchange Commission including, among other things,
risks as to whether any final or secondary data will, if and when
available, be encouraging, positive or will otherwise lead to an
effective or approved product, whether we will be able to
demonstrate efficacy or gain necessary approvals to market and
commercialize any product, whether the FDA will accept our data,
permit us to submit a BLA, grant a license, or approve RI-002 for
marketing, whether we will meet any of our clinical or regulatory
milestones, develop any new products or expand existing ones,
receive FDA approval of our new facility, changes in regional and
worldwide supply and demand for source plasma, whether we will be
able to attract sufficient donors and operate the new facility
effectively or profitably, whether we can sell our plasma in the
marketplace at prices that will lead to adequate amounts of
revenue, whether we will be able to sustain the listing of our
common stock on the NASDAQ Capital Market and whether we will meet
any timing targets expressed by the Company. Therefore,
current and prospective security holders are cautioned that there
also can be no assurance that the forward-looking statements
included in this press release will prove to be accurate. In light
of the significant uncertainties inherent to the forward-looking
statements included herein, the inclusion of such information
should not be regarded as a representation or warranty by ADMA or
any other person that the objectives and plans of ADMA will be
achieved in any specified time frame, if at all. Except to the
extent required by applicable laws or rules, ADMA does not
undertake any obligation to update any forward looking statements
or to announce revisions to any of the forward-looking
statements.
CONTACT: Brian Lenz
Vice President and Chief Financial Officer
201-478-5552
www.admabiologics.com
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