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Makers of Ampligen Announce a $4 Million Loss

  [ 1 vote ]   [ Discuss This Article ]
www.ProHealth.com • August 21, 2013


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

Press Release: August 09, 2013 16:23 | Source: Hemispherx Biopharma, Inc.

PHILADELPHIA, Aug. 9, 2013 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE:HEB) announced its financial results for the three months ended June 30, 2013. The net loss (including non-cash effects) was approximately $4,283,000 or $(0.03) per share as compared to a net loss of $3,000,000 or ($0.02) per share for the same three month period in 2012. This Quarter-to-Quarter increase in net loss of approximately $1,283,000 was predominantly caused by:a non-cash write-down of existing Alferon N Injection® work in process inventory for $458,000; and an increase of approximately $470,000 related to continued efforts to seek regulatory approval (U.S.A. and abroad) of the Ampligen® NDA for Chronic Fatigue Syndrome including costs related to clinical studies, research, raw material production and various GMP validation procedures at our New Brunswick, NJ facility.

Cash, cash equivalents and marketable securities were approximately $32,523,000 at June 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 $25,472,000 at June 30, 2013.

Our facility in New Brunswick, NJ produces the active pharmaceutical ingredient for Alferon® and raw materials and drug intermediates for the experimental product Ampligen®. The facility enhancement project is in its final stage with construction complete. The validation phase of the Alferon® manufacturing project is currently underway as we prepare to undertake the Installation Qualification Process phase of the enhancement project. Approximately $7,709,000 has been spent to date on the project. While facility upgrades are intended to enhance the Alferon® manufacturing process, this project has not impacted 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 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. 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 U.S. Food and Drug Administration 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




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