SIGA Technologies Submits Response to BARDA RFP

May 14, 2009 at 12:00 AM EDT

NEW YORK, May 14, 2009 (GlobeNewswire via COMTEX News Network) -- SIGA Technologies, Inc. (Nasdaq:SIGA), a company specializing in the development of drugs to fight biowarfare pathogens, today announced that on May 11, 2009, it submitted its response to the Biomedical Advance Research and Development Authority (BARDA) regarding the agency's outstanding RFP for the procurement of 1.7 million courses of a smallpox antiviral.

Additionally, SIGA reported its results of operations for the first quarter of 2009. Revenues for the quarter ended March 31, 2009 were $1.9 million, compared to $2.0 million for the same period last year. The majority of the revenues recognized during the quarter were generated from grants and contracts supporting the development of ST-246(r) and its alternative formulations.

R&D expenses for the quarters ended March 31, 2009 and 2008, were $2.7 million and $2.8 million, respectively, representing a slight decline which is chiefly due to a decrease in depreciation expense related to lower capital expenditures.

Operating loss for the first quarter of 2009 was $2.9 million, compared to a loss of $2.0 million in the same quarter last year. The increase in operating loss is primarily attributable to an increase in SG&A expenses during the quarter.

First quarter net loss was $6.8 million compared to a net loss of $860,000 for the same period in the prior year. The increase in net loss for the quarter is primarily attributable to the recognition of a non-cash loss of $3.9 million, which in turn reflects the increase in the fair market value of certain warrants to purchase common shares of the Company's stock, compared to a non-cash gain of $1.1 million in the 2008 period. Loss per share, on a diluted basis, for the quarter was $0.19 as compared to a loss of $0.03 for the same period last year.

The Company's cash balance as of March 31, 2009 was $1.6 million, compared to $2.3 million as of December 31, 2008.

Dr. Eric Rose, SIGA's CEO, commented, "Just as the first quarter was a watershed period in SIGA's history with the issuance of the long-awaited RFP, the current period has even more significance for the Company as we submitted our response to it on May 11.

"In addition to the RFP and its associated activities, we continued to focus on our NDA submission objectives for ST-246 during the first quarter. We completed a demonstration of our ability to manufacture ST-246 at 1/10th commercial scale and will use capsules manufactured in this process in a number of initiatives, including a human safety study anticipated to start in June and separate stability testing.

"Separately, we are also in the midst of a study using animal models to investigate the effect of ST-246 on the safety and efficacy of smallpox vaccinations. We also continue to make progress with our other drug programs, which are in earlier stages of clinical development."

About SIGA Technologies, Inc.

SIGA Technologies is applying viral and bacterial genomics and sophisticated computational modeling in the design and development of novel products for the prevention and treatment of serious infectious diseases, with an emphasis on products for biological warfare defense. SIGA believes that it is a leader in the development of pharmaceutical agents to fight potential bio-warfare pathogens. SIGA has antiviral programs targeting smallpox and other Category A pathogens, including arenaviruses (Lassa fever, Junin, Machupo, Guanarito, Sabia, and lymphocytic choriomeningitis), dengue virus, and the filoviruses (Ebola and Marburg). For more information about SIGA, please visit SIGA's web site at http://www.siga.com/.

The SIGA Technologies, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=4504

Forward-looking Statements

This press release contains or implies certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the efficacy of potential products, the timelines for bringing such products to market and the continued development and possible eventual approval of such products. Forward-looking statements are based on management's estimates, assumptions and projections, and are subject to uncertainties, many of which are beyond SIGA's control. Actual results may differ materially from those anticipated in any forward-looking statement. Factors that may cause such differences include the risks that (i) potential products that appear promising to SIGA or its collaborators cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (ii) SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products, (iii) SIGA may not be able to obtain anticipated funding for its development projects or other needed funding, (iv) SIGA may not be able to secure funding from anticipated government contracts and grants, (v) SIGA may not be able to secure or enforce sufficient legal rights in its products, including sufficient patent protection for its products, (vi) regulatory approval for SIGA's products may require further or additional testing that will delay or prevent approval, (vii) the Biomedical Advanced Research & Development Authority may not complete the procurement set forth in its solicitation for the acquisition of a smallpox antiviral for the strategic national stockpile, or may complete it on different terms; (viii) SIGA's proposed drug candidate for responding to any governmental solicitation for purchase may not meet the requirements of the solicitation; (ix) the volatile and competitive nature of the biotechnology industry may hamper SIGA's efforts, (x) changes in domestic and foreign economic and market conditions may adversely affect SIGA's ability to advance its research or its products, and (xi) changing federal, state and foreign regulation on SIGA's businesses may adversely affect SIGA's ability to advance its research or its products. More detailed information about SIGA and risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this press release, is set forth in SIGA's filings with the Securities and Exchange Commission, including SIGA's Annual Report on Form 10-K for the fiscal year ended December 31, 2008, and in other documents that SIGA has filed with the Commission. SIGA urges investors and security holders to read those documents free of charge at the Commission's Web site at http://www.sec.gov. Interested parties may also obtain those documents free of charge from SIGA. Forward-looking statements speak only as to the date they are made, and, except for any obligation under the U.S. federal securities laws, SIGA undertakes no obligation to publicly update any forward-looking statement as a result of new information, future events or otherwise.

This news release was distributed by GlobeNewswire, www.globenewswire.com

SOURCE: SIGA Technologies, Inc.

KCSA Strategic Communications
          Todd Fromer
            212-896-1215
            Tfromer@kcsa.com
          Marybeth Csaby
            212-896-1236
            mcsaby@kcsa.com

 

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