Full Press Release Details
Company/Investor Contact:
CJones & Associates Public Relations
Hemispherx Biopharma,
Inc. Announces $1 Million Registered Direct Offering
PHILADELPHIA, FEBRUARY 2, 2017 -
Hemispherx Biopharma, Inc. (NYSE MKT: HEB) (the "Company" or "Hemispherx"), announced today that it has
entered into definitive agreements with several institutional investors for an offering of shares of common stock with gross proceeds
of approximately $1 million in a registered direct offering. The closing of the offering is expected to take place on or
about February 6, 2017, subject to the satisfaction of customary closing conditions.
In connection with the offering, the Company
will issue registered shares of common stock at a purchase price of $0.55 per share. Concurrently in a private placement,
for each share of common stock purchased by an investor, such investor will receive from the Company an unregistered warrant to
purchase 0.75 of a share of common stock. The warrants have an exercise price of $0.75 per share, will be exercisable six
months after issuance, and will expire five years from the initial exercise date.
Rodman & Renshaw, a unit of H.C. Wainwright
& Co., LLC, is acting as the exclusive placement agent in connection with this offering.
Company intends to use the net proceeds from the offering for preparation
for technology transfer opportunities, expenses related to Ampligen manufacturing and for other working capital and general corporate
The shares of common stock described above
(but not the warrants or the shares of common stock underlying the warrants) are being offered pursuant to a shelf registration
statement (File No. 333-205228). Such shares of common stock may be offered only by means of a prospectus, including a prospectus
supplement, forming a part of the effective registration statement.
The warrants and the shares of common stock
underlying the warrants issued in the offering have not been registered under the Securities Act of 1933, as amended, or applicable
state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United
States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of
the Securities Act and such applicable state securities laws.
This press release shall not constitute
an offer to sell or the solicitation of an offer to buy any of the securities described herein. There shall not be any offer,
solicitation of an offer to buy, or sale of securities in any state or jurisdiction in which such an offering, solicitation, or
sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The
Company will file a prospectus supplement and accompanying prospectus with the SEC relating to such shares of common stock, and
following such filing, copies of the prospectus supplement and the accompanying base prospectus relating to this offering may
be obtained at the SEC's website at http://www.sec.gov, or by contacting H.C. Wainwright & Co. by calling 646-975-6996
or by e-mail at placements@hcwco.com.
About Hemispherx Biopharma
Hemispherx 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. Our 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. Hemispherx
wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For
more information please visit www.hemispherx.net.
Forward-Looking Statements
To the extent 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, market and other conditions, the satisfaction of customary closing conditions related to the offering and the impact of
general economic, industry or political conditions in the United States or internationally, 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.
The information 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.
Information 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; our ability to adequately fund our 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; our ability to accurately predict the future market conditions; manufacturing
difficulties or delays; dependence on the effectiveness of our 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
our 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 because of the damage caused by the flood
that occurred in January 2016 at the facility. At this time, we believe that all repairs to the manufacturing facility have been
completed. 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 our 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