Hemispherx Reports Six Months Ended June 30, 2018 Financial Results and Provides Business Update
August 15 2018 - 8:38AM
Hemispherx Biopharma, Inc. (NYSE American:HEB), an
immuno-pharma R&D and emerging commercial growth company
focused on unmet medical needs in immunology, has announced its
financial results for the six months ended June 30, 2018.
The Company has made great progress pursuing Ampligen in
combination therapeutic treatments in immuno-oncology. Significant
synergistic anti-tumor activity and/or increased median survival
has been observed when Ampligen was added to other anti-cancer
agents in three pre-clinical studies. As a result, the Company is
now working with several top U.S. cancer research centers to
initiate Phase 1 and Phase 2 clinical trials combining Ampligen
with FDA-approved checkpoint blockade therapies in a variety of
solid tumors.
Hemispherx continues to clarify the regulatory pathway for
approval of Ampligen to treat CFS in the United States. It expanded
its production capabilities in order to provide a reliable supply
of Ampligen for all of its clinical and expanded access programs in
the U.S., Canada, Europe and commercial program in Argentina. With
the ability to produce Ampligen in sizable commercial lots, the
Company is laying the foundation for significant revenue growth, as
it sees ongoing scientific and medical validation of Ampligen's
potential to fill large unmet medical needs in Myalgic
Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and a variety
of immune-modulated illnesses.
Six Months Ended June 30, 2018 Financial
Highlights As of June 30, 2018, Hemispherx had $4.2
million in cash and cash equivalents, compared to $2.1 million at
December 31, 2017. Cash used in operations was $5.2 million for the
six months ended June 30, 2018, compared to $5.3 million in the
same period in 2017. The net loss was $5.1 million, or $0.13 per
share, for the six months ended June 30, 2018, compared to a net
loss of $5.0 million, or $0.19 per share, in the same period in
2017.
Ampligen Moving Towards CommercializationDuring
the quarter, Hemispherx successfully completed the first phase of
its Ampligen production plan. The first commercial-sized lot of
Ampligen of 8,500 vials passed all required testing for regulatory
release for human use. The vials are earmarked for distribution to
U.S.-based ME/CFS expanded access programs in Nevada and North
Carolina, U.S. clinical trials in immuno-oncology, European and
Canadian expanded access programs and for certain testing and
validation required for commercial launch in Argentina.
The second commercial-sized lot of Ampligen is currently
undergoing release testing and is intended to be available to
supply initial demand for Ampligen’s anticipated commercial launch
in Argentina, where it is approved for the treatment of severe CFS.
The Argentine commercial approval is the first-ever approval of a
drug for severe CFS.
About Hemispherx Biopharma Hemispherx
Biopharma, Inc. is an immuno-pharma R&D and emerging commercial
growth company focused on unmet medical needs in immunology.
Hemispherx’s flagship products include Alferon N Injection® and the
experimental therapeutic rintatolimod (tradenames Ampligen® or
Rintamod®). Rintatolimod is an experimental RNA nucleic acid being
developed for globally important debilitating diseases and
disorders of the immune system, including Myalgic
Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Hemispherx’s
platform technology includes components for potential treatment of
various severely debilitating and life threatening diseases.
Because rintatolimod is experimental in nature, it is not
designated safe and effective by the FDA for general use and is
legally available only through clinical trials.
Cautionary StatementSome of the statements
included in this press release may be forward-looking statements
that involve a number of risks and uncertainties. For those
statements, we claim the protection of the safe harbor for
forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995. Any forward-looking statements set
forth in this press release speak only as of the date of this press
release. We do not undertake to update any of these forward-looking
statements to reflect events or circumstances that occur after the
date hereof. This press release and prior releases are available at
www.hemispherx.net. The information found on our website is not
incorporated by reference into this press release and is included
for reference purposes only.
ContactHemispherx Biopharma, Inc. Phone Number:
800-778-4042 Email: IR@hemispherx.net
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