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Company/Investor Contact: Charles Jones CJones & Associates Public Relations 888-557-6480 305-987-7418 cjones@cjonespr.com Hemispherx Biopharma Announces Financial Results in its Quarterly Report for the Nine Months Ende

Key Takeaway: Company/Investor Contact: CJones & Associates Public Relations Biopharma Announces Financial Results in its Quarterly Report for the Nine Months Ended September 30, 2016 Call Scheduled for Tuesday, November 15, 2016 at 11:00 AM EST - November 14, 2016 - Hemispherx Biopharma

Full Press Release Details

Company/Investor Contact:
CJones & Associates Public Relations
Biopharma Announces Financial Results in its Quarterly Report for the
Nine Months Ended September 30, 2016
Call Scheduled for Tuesday, November 15, 2016 at 11:00 AM EST
- November 14, 2016 - Hemispherx Biopharma (NYSE MKT: HEB) announces the filing of its Quarterly Report and its financial
results for the nine months ended September 30, 2016. The net loss was approximately $6,329,000 or $(0.30) per share as compared
to a net loss of $12,093,000 or ($0.62) per share for the same nine month period in 2015. Cash, cash equivalents and marketable
securities were approximately $8,009,000 at September 30, 2016 as compared to $8,910,000 as of December 31, 2015.
Biopharma recently made changes to its senior management team and implemented austerity measures which included the reduction
of executive compensation and elimination of non-essential contractors and personnel. These measures have resulted in a significant
reduction in costs and expenses. The Company is now focusing on commercial success by seeking co-development partners and working
closely with the research and regulatory communities to bring disease fighting technologies to the world.
of this quarter, on August 18, 2016, we received approval of our New Drug Application ("NDA") from Administracion
Nacional de Medicamentos, Alimentos y Tecnologia Medica ("ANMAT") for commercial sale of rintatolimod (U.S. tradename:
Ampligen ) in the Argentine Republic for the treatment of severe myalgic encephalomyelitis/chronic fatigue syndrome ("ME/CFS").
The product will be marketed by GP Pharm, our commercial partner in Latin America. We believe that rintatolimod is the first drug
to receive approval for this indication anywhere in the world.
will host a conference call at 11:00 a.m. Eastern Standard Time (EST) on Tuesday, November 15, 2016 to provide a general business
update. Hemispherx will respond to various stockholder questions submitted prior to the call.
of the conference call will be available on the Company's website approximately one hour following the conclusion of the
Date: Tuesday, November 15, 2016
Time: 11:00 a.m. EST
Dial-in numbers: 800-346-7359 (domestic)
973-528-0008 (international)
Conference number: 27781
Questions: ir@hemispherx.net by 6:00 AM EST on Monday, November 14, 2016
Audio Replay: http://ir.hemispherx.net/Events_Presentations
Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug
entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection
and the experimental therapeutics rintatolimod (tradenames Ampligen or Rintamod ) and Alferon LDO. Rintatolimod
is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system,
including Chronic Fatigue Syndrome. Hemispherx's platform technology includes components for potential treatment of various
severely debilitating and life threatening diseases. Because both Rintatolimod and Alferon LDO are experimental in nature,
they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical
trials. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N
Injection ), approved for sale in the U.S. and Argentina. The FDA approval of Alferon N Injection is limited to the treatment
of refractory or recurrent external genital warts in patients 18 years of age or older. The Company's Alferon N approval
in Argentina includes the use of Alferon N Injection (under the pending brand name "Naturaferon") for use in any patients
who fail or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. Rintamod
has received approval in the Argentine Republic to treat severe cases of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).
It will be marketed by GP Pharm, Hemispherx's commercial partner in Latin America. The Company wholly owns and exclusively
operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit
that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant
to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as (intends", "plans",
"potential", "potentially", "possible" and similar expressions are intended to identify forward-looking
statements. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its
plans will be achieved. These forward-looking statements are neither promises nor guarantees of future performance, and are subject
to a variety of risks and uncertainties, many of which are beyond Hemispherx's control, which could cause actual results
to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include
those set forth in the Disclosure Notice, below, as well as the risks described in Hemispherx's filings with the Securities
and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K. You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update
or revise the information contained in this press release, whether as a result of new information, future events or circumstances
or otherwise revise or update this release to reflect events or circumstances after the date hereof.
in this press release includes certain "forward-looking" statements including without limitation statements about additional
steps which the FDA may require and Hemispherx may take in continuing to seek commercial approval of the Ampligen NDA for
the treatment of Chronic Fatigue Syndrome in the United States. The final results of these and other ongoing activities could
vary materially from Hemispherx's expectations and could adversely affect the chances for approval of the Ampligen
NDA in the United States and other countries. The clinical studies referenced herein have been previously reviewed by the FDA
and are not, in and of themselves, a sufficient basis for approval in the United States. Any failure to satisfy the FDA regulatory
requirements or the requirements of other countries could significantly delay, or preclude outright, approval of the Ampligen
NDA in the United States and other countries.
contained in this news release, other than historical information, should be considered forward-looking and is subject to various
risk factors and uncertainties including, but not limited to, general industry conditions and competition; general economic factors;
the Company's ability to adequately fund its projects; the impact of pharmaceutical industry regulation and healthcare legislation
in the United States and internationally; trends toward healthcare cost containment; technological advances, new products and
patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the
Company's ability to accurately predict the future market conditions; manufacturing difficulties or delays; dependence on
the effectiveness of the Company's patents and other protections for products; and the exposure to litigation, including
patent litigation, and/or regulatory actions; and numerous other factors discussed in this release and in the Company's
filings with the Securities and Exchange Commission. The production of new Alferon API inventory will not commence until
the validation phase is complete. While the facility is approved by FDA under the Biological License Application ("BLA")
for Alferon , this status will need to be reaffirmed by a successful Pre-Approval Inspection by the FDA prior to commercial
sale of newly produced inventory product. The validation phase was delayed to repair the damage caused by a flood that occurred
on January 5, 2016 at the facility. If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon
API, we will need FDA approval as to the quality and stability of the final product to allow commercial sales to resume. With
regard to our NDA for Ampligen to treat CFS, we note that there are additional steps which the FDA has advised us to take
in our seeking approval. The final results of these efforts and/or any other activities could vary materially from Hemispherx's
expectations. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly
delay, or preclude outright, approval of Ampligen in the United States and other countries. No evidence is suggested that
Ampligen will be commercially approved for any treatment or that Alferon N Injection will be commercially approved for
potential new treatment indications or for new manufacturing procedures. Approval of Rintamod for CFS in the Argentine Republic
does not in any way suggest that the Ampligen NDA in the United States will obtain commercial approval. Also, it is noted
that ANMAT approval is only an initial, but important, step in the overall successful commercialization. Namely, additional steps
required for commercialization in Argentina will require, among others, an appropriate reimbursement level, appropriate marketing
strategies, completion of manufacturing preparations for launch (including possible requirements for approval of final manufacturing,
etc., and there are no assurances as to whether or when such multiple subsequent steps will be successfully performed to result
in an overall successful commercialization and product launch.
Last updated: Nov 15, 2016