PHILADELPHIA, Nov. 17, 2015 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE:HEB) announced its financial results for the nine months ended September 30, 2015. The net loss (including non-cash effects) was approximately $12,093,000 or $(0.05) per share as compared to a net loss of $12,994,000 or ($0.07) per share for the same nine month period in 2014.
Cash, cash equivalents and marketable securities were approximately $12,375,000 at September 30, 2015 as compared to $16,108,000 as of December 31, 2014.
On September 28, 2015, the Company announced formal granting of a new composition of matter patent by the European Patent Office on Ampligen® which may extend through year 2029 and potentially beyond. This important milestone was achieved through the efforts of William A. Carter, the company’s Chairman and CEO, leading a research team at the company’s wholly owned R and D laboratories in New Brunswick, NJ. The patents are expected to be issued in up to 25 countries.
Hemispherx Biopharma, Inc. will now collaborate with a new partner, myTomorrows, to provide access to its natural alpha interferon for patients that have become intolerant to treatment with recombinant interferon or where such treatment fails. Through myTomorrows' Internet-based platform we plan to make this unique interferon formulation available to patients and doctors in Brazil, Columbia and Chile, through an Early Access Program.
We have recently expanded our international collaborative programs with both major components of our treatment platform (Ampligen®, an experimental therapeutic, and Alferon® N, an FDA approved commercial product, more fully described below) to create an expanded patient access path while seeking formal approval in the European Union, Australia, and New Zealand.
Our overall objectives also include 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 for sales in the United States and Argentina. In addition, we have formed collaborations with multiple research laboratories around the world to examine Ampligen®, an experimental therapeutic, and Alferon N, an FDA-approved commercial product (for certain types of genital warts (HPV)), as potential preventatives for, and treatments of, Ebola Virus Disease (EVD) and other hazardous viruses including pandemic influenza and Middle East Respiratory Syndrome (MERS). Promising clinical results in immunotherapy of difficult-to-treat human malignancies with Ampligen® are also being aggressively pursued. Our ability to commercialize our products, widen commercial therapeutic indications of Alferon N Injection® and/or capitalize on our collaborations with research laboratories to examine our products as potential preventatives for, and treatments of newly emerging viral diseases are subject to a number of significant risks and uncertainties including, but not limited to, our ability to enter into more definitive agreements with some of the research laboratories and others with whom we are collaborating, to fund and conduct additional testing and studies, whether or not such testing is successful or requires additional testing and meets the requirements of the FDA and comparable foreign regulatory agencies. We do not know when, if ever, our products will be generally available for commercial sale for any new indications.
About Alferon N Injection®
Alferon® N is the only natural source, multi-species alpha interferon currently approved for sale in the U.S. Alferon® N is approved in the U.S. for the treatment of refractory or recurring external genital warts caused by human papilloma virus in patients 18 years of age or older.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the 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 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
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; the Company’s ability to adequately fund its 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; the Company’s ability to accurately predict the future market conditions; manufacturing difficulties or delays; dependence on the effectiveness of the Company’s patents and other protections for products; and the exposure to litigation, including patent litigation, and/or regulatory actions; as well as numerous other numerous other factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. 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 final results of these efforts and/or any other activities could vary materially from Hemispherx’s expectations. For instance, any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of Ampligen® and any potential income derived therefrom in the United States and other countries. The re-launch of Alferon N, as a commercial product and potential source of income in the United States cannot commence until regulatory approvals have been obtained.
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, are based upon the current beliefs and expectations of the Company’s management, are subject to significant risks and uncertainties 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, 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. No evidence is suggested that Ampligen® will ever be commercially approved for the new potential treatment indications mentioned in this release.
Charles Jones CJones & Associates Public Relations Office: 888-557-6480 Cell: 305-987-7418 Email: firstname.lastname@example.org
Source:Hemispherx Biopharma, Inc.