(Source: PrimeNewswire)
PHILADELPHIA, Nov. 9, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) announced its financial results for the three months ended September 30, 2009. The net loss (including non-cash expenses) for the fiscal quarter was approximately $2,435,000 or $0.02 per share compared to a loss of approximately $3,415,000 or $0.05 per share for the same period in 2008. The decrease in loss was primarily due to 1) lower R&D expenses related to the preparation of the Ampligen(R) NDA and, 2) the effect of reducing G&A expenses pursuant to the cash conservation and cost reduction program implemented by Management in early 2009. The net loss for the nine months ended September 30, 2009 including non-cash expenses was $9,392,000 or $0.09 per share compared to a loss of $9,382,000 or $0.13 per share in 2008.
Cash and cash equivalents were $61,042,000 as of September 30, 2009 reflecting an increase of $54,923,000 since year end 2008. This increase primarily reflects the net proceeds of two equity placements in May, 2009 as well as proceeds derived from an equity financing agreement.
The Company presented new data at the Chronic Fatigue Syndrome (CFS) Advisory Committee to the Department of Health and Human Services (HHS) on October 29, 2009, regarding patient referral patterns in CFS and outlined new collaborative clinical research for the "Longitudinal Study of Gene Expression in CFS". On the seasonal and pandemic influenza prevention front, the Company continued discussions with its Japanese collaborative partners regarding proposed means to enhance the effectiveness of vaccines via its experimental therapeutic, Ampligen(R). In the prophylactic influenza protection area, the Company planned new clinical studies directed at North American clinical sites for Alferon(R) LDO, a new experimental oral formulation of its Food and Drug Administration (FDA) approved biologic, Alferon N Injection(R).
The FDA has not informed the Company as to any outstanding responses required in order to take action on the pending New Drug Application (NDA). The target date for action on the NDA under the Prescription Drug User Fee Act (PDUFA) was extended by the FDA in May, 2009. The Company is finalizing certain responses with respect to third-party based animal toxicology and manufacturing programs it believes should be considered post-approval issues and that do not constitute new or additional FDA requests.
The Company has initiated a $4.4 million capital investment program to upgrade its production facility located in New Brunswick, New Jersey.
