Hemispherx Biopharma Announces Financial Results for the Three Months Ended September 30, 2013

Qualification Phase for Alferon(R) Manufacturing Underway

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| Source: Hemispherx Biopharma, Inc.

PHILADELPHIA, Nov. 8, 2013 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) announced its financial results for the three months ended September 30, 2013. The net loss (including non-cash effects) was approximately $5,136,000 or $(0.03) per share as compared to a net loss of $6,587,000 or ($0.05) per share for the same three month period in 2012. This Quarter-to-Quarter decrease in net loss of approximately $1,451,000 was predominantly caused by:

  • An approximate $509,000 reduction in overall operating expenses;
  • A non-cash impairment loss of approximately $800,000, recognized in the three-month period of 2013 to reflect the decline in the market value of our Marketable Securities (Mutual Bond Funds); and
  • The quarterly fiscal revaluation of certain redeemable warrants, resulting in a non-cash gain of approximately $2,006,000 in comparing same three month periods of 2013 to 2012.

Cash, cash equivalents and marketable securities were approximately $29,221,000 at September 30, 2013 as compared to $43,953,000 as of December 31, 2012. Cash, cash equivalents and marketable securities, net of the Margin Loan used for the facility enhancement project at our 43,000 sq. ft. FDA approved New Brunswick facility, was approximately $22,170,000 at September 30, 2013.

We own and operate a 43,000 sq. ft. U.S. Food and Drug Administration ("FDA") approved facility in New Brunswick, NJ to produce the active pharmaceutical ingredient for Alferon® and raw materials and drug intermediates for the experimental product Ampligen®. We are currently in the Installation and Operation Qualification phase for Alferon® production of the enhancement project. Approximately $7,733,000 has been spent to date on facility upgrades that are intended to enhance our Alferon® manufacturing process without impacting our capability to manufacture Ampligen® raw materials and drug intermediates.

Our overall objectives include our plans to continue seeking approval for commercialization of Ampligen® in the United States and abroad as well as to widen existing commercial therapeutic indications of Alferon N Injection® presently approved in the United States and Argentina.

DISCLOSURE NOTICE

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 production of new Alferon® API inventory will not commence until the capital improvement and validation phases are complete. While the facility is approved by FDA under the Biological License Application ("BLA") for Alferon®, this status will need to be reaffirmed upon the completion of the facility's enhancements prior to commercial sale of newly produced inventory product. 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. 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. 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. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, changes in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. The final results of these efforts could vary materially from Hemispherx's expectations.

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 Ampligen® and Alferon® LDO. Ampligen® 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 Ampligen® 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 Injection® approval in Argentina includes the use of Alferon N Injection® (under the brand name "Naturaferon") for use in any patients who fail, or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. The Company 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," 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, above, 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.

Company/Investor Contact:
Dianne Will
Hemispherx Biopharma, Inc.
518-398-6222