By: Matt Rego
Unmet medical treatment solutions company, SIGA Technologies, Inc. (OTC Pink: SIGA) saw shares rise around 7.50% on Tuesday, July 05, 2016. The biomedical company normally sees paltry average daily volume of around 72,681 shares. However, nearly 363,000 shares of SIGA Technologies, Inc. (OTC Pink: SIGA) or $381,150 in dollar volume has already exchanged hands in the first several hours of trading on Tuesday.
The big news that is driving the rally in shares of SIGA Technologies, Inc. (OTC Pink: SIGA) comes from a Form 8-K that detailed of a change to the company’s definitive agreement with the Biomedical Advanced Research And Development Authority (BARDA). Among the most significant aspects of the modified agreement SIGA Technologies, Inc. (OTC Pink: SIGA) is the fact that the company could be receiving payments of $82 million sooner than the company anticipated. Here is the Form 8-K detailing of the modified agreement:
Form 8-K for SIGA TECHNOLOGIES INC
Entry into a Material Definitive Agreement, Financial Statements and Exhibi
Item 1.01 Entry into a Material Definitive Agreement.
On June 28, 2016, SIGA Technologies, Inc. (“SIGA”), a Delaware corporation, entered into a modification (the “Modification”) of its 2011 procurement contract with the Biomedical Advanced Research and Development Authority (“BARDA”) of the United States Department of Health and Human Services (the “Contract”).
The total dollar value of the Contract is unchanged. Pursuant to the Modification, SIGA may receive up to $82 million earlier than anticipated. The changes to the Contract reflected in the Modification include:
An increase of $36.20 per course in the payment for the manufacture and delivery of 1.7 million courses of TPOXX. The increase in delivery payments will total $61.5 million and was accomplished by reducing the contractual holdback amount that is tied to FDA approval of TPOXX from $102.5 million to $41 million.
A change in the requirements for a $20.5 million (5% of contract price) milestone in the Contract. For payment, this milestone now requires SIGA to submit documentation to BARDA indicating that data covering the first 100 subjects enrolled in the phase III pivotal safety study have been submitted to and reviewed by a Data & Safety Monitoring Board (“DSMB”) and that such DSMB recommends continuation of the safety study, as well as submission of the final pivotal rabbit efficacy study report to the United States Food & Drug Administration (the “FDA”). Previously, this milestone required the successful submission to the FDA of a complete application for TPOXX� regulatory approval.
The foregoing description is qualified in its entirety by reference to the text of the Modification, which is attached hereto as Exhibit 10.1.
Item 9.01. Financial Statements and Exhibits.
Exhibit No. Description
10.1 Amendment of Solicitation/Modification of Contract 0013, dated June 28,
2016, to Agreement, dated May 13, 2011, between the Biomedical Advanced
Research and Development Authority of the United States Department of
Health and Human Services and SIGA (portions of this exhibit have been
omitted and separately filed with the Securities and Exchange Commission
with a request for confidential treatment).
SIGA is a company specializing in the development and commercialization of solutions for serious unmet medical needs and biothreats. Their lead product is Tecovirimat, also known as ST-246, an orally administered antiviral drug that targets orthopoxviruses. While Tecovirimat is not yet licensed as safe or effective by the U.S. Food & Drug Administration, it is a novel small-molecule drug that is being delivered to the Strategic National Stockpile under Project BioShield.