PHILADELPHIA, March 29, 2011 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE Amex:HEB) announced its financial results for the fiscal year ended December 31, 2010. The net loss for the year (including non-cash effects) was approximately $13,136,000 or ($0.10) per share as compared to a net loss of $7,180,000 or ($0.07) per share in 2009. An adjustment and restatement at December 31, 2009 to record the change of fair value of the liability related to certain warrants issued in May 2009 resulted in a non-cash gain of $6,258,000 in 2009 as compared to a non-cash gain of $879,000 in 2010. This redeemable warrant liability will continue to be revalued to fair market each fiscal quarter and the resulting non-cash adjustment can have a significant impact on overall net profit or loss of the Company.
Overall Research and Development ("R&D") costs in 2010 were approximately $7,613,000 as compared to $6,995,000 for the same period in 2009. R&D costs for Ampligen®, an experimental therapeutic, and related expenses were approximately $2,239,000 lower in 2010 primarily due to the additional scientific and regulatory effort spent in 2009 on the preparation and filing of the Ampligen® NDA. Our Chronic Fatigue Syndrome ("CFS") regulatory effort is being actively pursued in the U.S. and through GP Pharm Latinoamerica in certain non-U.S. locations. R&D expenses related to Alferon N Injection® and Alferon® LDO were higher by $2,874,000 in 2010 primarily due to efforts expended to significantly enhance the Alferon® manufacturing process for a potential resumption of commercial sales of Alferon N Injection® in the 2nd half of year 2011. Also, R&D expenses were incurred to refine new diagnostic approaches designed to more reliably identify patients with CFS and to identify potentially superior biomarkers to monitor therapeutic intervention with Ampligen®. This program is designed to identify specific treatable molecular aspects within the overall CFS disease process in order to improve patient outcomes, and is also expected to have a significant impact on the design of CFS studies with Ampligen®. The time for the Company to respond to the Complete Response Letter on the pending Ampligen® New Drug Application was recently extended by the Food and Drug Administration ("FDA") to November 2011.
Cash, cash equivalents and marketable securities were approximately $44,387,000 as of December 31, 2010. Cash used in operations in 2010 was $11,886,000 compared to $9,297,000 for the same period in 2009.
As previously announced on February 17, 2011, the Company received a notice from the Staff of the NYSE Amex (the "Amex") that the Company was not in compliance with Section 704 of the Amex Company Guide which required the Company to hold its 2010 Annual Stockholders' Meeting no later than December 31, 2010. The Company was given until March 21, 2011 to submit a plan to regain compliance with this requirement. The delay in holding the 2010 Meeting resulted from the time required to respond to comments the Company had received from the SEC related to the SEC's review of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2009. The specific comments causing the delay related to the Company's accounting treatment of the May 2009 warrants discussed above. Despite the Company's best efforts to resolve the matter to allow the annual meeting to be held by December 31, 2010, final resolution of the SEC staff's accounting comments did not occur until mid-February 2011. The Company immediately filed an amended and restated 2009 10-K, amended and restated quarterly reports on Form 10-Q for the first three quarters of 2010 and its definitive proxy statement for the 2010 Meeting. The 2010 Stockholders' Meeting was held on March 17, 2011. As a result on March 23, 2011, the Company received formal notification from the Amex that "the Company has resolved the continued listing deficiency referenced in the NYSE Amex LLC's letter dated February 17, 2011".
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. Ampligen® is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system. 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.
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, change 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. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen® and Alferon® LDO) are experimental in nature and as such 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. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. The planning, completion, results or submission of clinical trials do not imply that any study product will ever be approved commercially for the studied or other treatment indications. Similarly, the resumption of commercial sales of Alferon N Injection® is predicated on certain technical achievements and acceptance by FDA of resulting data reports, which may or may not occur. Similarly, the new diagnostic initiatives of the Company in CFS may not be validated in wider clinical trials and thus may not be accepted by the FDA as a basis for evaluating the potential efficacy of Ampligen®.