Hemispherx Biopharma Announces Financial Results for the Three Months Ended September 30, 2012

Ampligen(R) New Drug Application and Pre-Approval Inspection Are Top Priorities

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| Source: Hemispherx Biopharma, Inc.

PHILADELPHIA, Nov. 2, 2012 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE:HEB) announced its financial results for the three months ended September 30, 2012. The net comprehensive loss for the period (including non-cash effects of the redeemable warrants valuation adjustment) was approximately $6,425,000 or $(0.04) per share as compared to a net comprehensive loss of approximately $3,269,000 or ($0.02) per share for the same period in 2011.

The fair value revaluation of the estimated liability related to certain redeemable warrants resulted in a non-cash loss of $1,968,000 in the three months ended September 30, 2012 as compared to a non-cash gain of $614,000 for the same period in 2011, resulting in a net increased non-cash loss of $2,582,000 accounted for in the a net comprehensive loss in comparing the three month periods.

If the non-cash impact of the fair value revaluation of certain redeemable warrants was discounted from the net comprehensive loss calculation to compare the three month periods ended September 30th, the net effect would be loss of $4,457,000 for 2012 as compared to $3,883,000 for 2011, or an increase of $574,000 (14.8%) that was predominantly caused by:

  • Production/Cost of Goods Sold increased approximately $780,000 for costs related to Alferon® Work-In-Process Inventory undertaking the fill, finish and packaging;
  • An increase in Research and Development costs of $607,000 related to our efforts towards the Ampligen® New Drug Application ("NDA") and preparedness for the FDA pre-approval inspections of the New Brunswick manufacturing facility;
  • These increases were partially offset by net unrealized and realized gain on marketable securities of $667,000 and an increase in investment income of $141,000.

Net Cash used in operating activities for the three months ended September 30, 2012 was approximately $2,704,000, as compared to $2,272,000 for the same period in 2011, an increase of $432,000 or 19%.

As of September 30, 2012, we had approximately $35,398,000 in Cash, Cash Equivalents and Marketable Securities (restricted and unrestricted), an increase of $6,643,000 as compared to June 30, 2012 and $1,007,000 as compared to December 31, 2011.

The U.S. Food and Drug Administration ("FDA") has scheduled for December 20, 2012 a meeting of the Arthritis Advisory Committee ("AAC") to discuss the Ampligen® New Drug Application for CFS which is currently under review by the FDA. The AAC meeting will be held from 8 a.m. to 5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31, Conference Center, the Great Room (Room 1503), Silver Spring, MD 20993-0002. Further details are available at https://federalregister.gov/a/2012-25878.  

The Prescription Drug User Fee Act ("PDUFA") review goal for the FDA to complete its review of Ampligen® for Chronic Fatigue Syndrome ("CFS") has been announced to be February 2, 2013. 

Along with the efforts related to the Ampligen® NDA, Hemispherx continues to move forward with enhancements to its FDA licensed manufacturing facility in New Brunswick, NJ to accommodate larger production volumes of its FDA-approved therapeutic, Alferon N Injection®. The project is continuing its construction phase with approximately $5,761,000 having been spent from project commencement through September 30, 2012 as compared to $1,695,000 from project commencement through December 31, 2011.

DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking" statements (explained below), including statements about the remaining steps to potentially gain FDA 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. These activities and the ultimate outcomes are subject to a variety of risks and uncertainties, including but not limited to risks that (i) the FDA may ask for additional data, information or studies to be completed or provided prior to approval; (ii) the FDA may require additional work related to the commercial manufacturing process to be completed prior to approval or may, in the course of the inspection of manufacturing facilities, identify issues to be resolved; (iii) the FDA may determine that the complete response submitted by Hemispherx is not "complete," potentially requiring the Company to conduct additional activities before it can re-file, if at all, the complete response; and (iv) until completion of the FDA review of the Ampligen® NDA, including the Advisory Committee review, and final approval of the product and prescribing information, if any, the specific patient population for which Ampligen® may be indicated will not be known. Any failure to satisfy the FDA's requirements could significantly delay, or preclude outright, approval of the Ampligen® NDA. In addition, the FDA's plans for the December 20, 2012 Advisory Committee review are tentative and are subject to change.

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® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen® and Alferon® LDO. 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 with the referenced disorders. 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. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). 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 "anticipate," "hope," and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations and represent the Company's judgment as of the date of this release. 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