UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15 (d) OF
THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): July 27, 2023

SIGA TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)

Delaware
 
0-23047
 
13-3864870
(State or other jurisdiction of incorporation or organization)
 
(Commission file number)
 
(I.R.S. employer identification no.)

31 East 62nd Street
New York, New York
 
10065
(Address of principal executive offices)
 
(Zip code)

Registrant’s telephone number, including area code: (212) 672-9100

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):


Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class
Trading Symbol(s)
Name of each exchange on which registered
common stock, $.0001 par value
SIGA
The Nasdaq Global Market
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.



Item 8.01
Other Events.

On July 27, 2023, SIGA Technologies, Inc. (the “Company”) announced that the U.S. Government exercised procurement options under the 19C Biomedical Advanced Research and Development Authority (BARDA) contract with the Company for the delivery of approximately $113 million worth of oral TPOXX® treatment courses and approximately $25 million worth of IV TPOXX® treatment courses. The Company expects to deliver approximately $113 million of oral TPOXX under this order in 2023 and to start delivering IV TPOXX under this order in 2024.

A copy of the press release related to this announcement is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01
Financial Statements and Exhibits.

(d) The following exhibits are included in this report:

Exhibit
No.
 
Description
 
Press Release, dated July 27, 2023.
104
 
Cover Page Interactive Data File (embedded within the Inline XBRL document).


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 
SIGA TECHNOLOGIES, INC.
 
 
 
By:
/s/ Daniel J. Luckshire
 
Name:
Daniel J. Luckshire
 
Title:
Chief Financial Officer
     
Date: July 28, 2023
   

 


EXHIBIT 99.1
 
SIGA Announces U.S. Government Procurement Orders of Approximately $138 Million for Oral and IV TPOXX®
 
Exercise of Procurement Options of Approximately $113 Million for Oral TPOXX and Approximately $25 Million for IV TPOXX under Current Contract reflects continuing global action to enhance smallpox preparedness

NEW YORK, (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company, today announced that the U.S. Department of Health and Human Services  exercised procurement options for the delivery of approximately $113 million worth of oral TPOXX® treatment courses and approximately $25 million worth of IV TPOXX® treatment courses. 
 
“Building on the orders SIGA received for TPOXX from 13 international customers and the U.S. Department of Defense in 2022, these most recent procurement orders further highlight that many global leaders in public heath recognize the importance of orthopoxvirus preparedness and the need to take action to keep people safe,” said Phil Gomez, CEO of SIGA. “We are pleased that we are able to consistently meet demand for oral TPOXX, which is driving substantial and increasingly diversified global revenue opportunities at SIGA.”
 
SIGA expects to fully deliver approximately $113 million of oral TPOXX under this order in 2023 and expects to start delivering IV TPOXX under this order in 2024.  Prior to delivery of IV TPOXX under this order, SIGA will be focused on fulfilling delivery obligations under a prior IV TPOXX order.    
 
This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) and Strategic National Stockpile, under Contract No. 75A50118C00019.


ABOUT SIGA TECHNOLOGIES, INC. and TPOXX®
 
SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness. Our lead product is TPOXX®, also known as tecovirimat and ST-246®, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. TPOXX is a novel small-molecule drug and the US maintains a supply of TPOXX under Project BioShield. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in 2018, and the IV formulation was approved for the same indication in 2022. The full label is available by clicking here. Oral tecovirimat received approval from the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom in 2022. The EMA and UK approvals include labeling for oral tecovirimat indicating its use for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox. The full label is available by clicking here. In September 2018, SIGA signed a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, for additional procurement and development related to both oral and intravenous formulations of TPOXX. For more information about SIGA, please visit www.siga.com.

About Smallpox
 
Smallpox is a contagious, disfiguring and often deadly disease that has affected humans for thousands of years. Naturally occurring smallpox was eradicated worldwide by 1980, the result of an unprecedented global immunization campaign. Samples of smallpox virus have been kept for research purposes. This has led to concerns that smallpox could someday be used as a biological warfare agent. A vaccine can prevent smallpox but is currently not recommended for routine vaccination.


FORWARD-LOOKING STATEMENTS
 
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements relating to the progress of SIGA’s development programs and timelines for bringing products to market, delivering products to ASPR, the enforceability of our procurement contracts, such as the 19C BARDA Contract (the "BARDA Contract"), with BARDA, the impact of the COVID pandemic and responding to the global outbreak of monkeypox. The words or phrases “can be,” “expects,” “may affect,” “may depend,” “believes,” “estimate,” “project” and similar words and phrases are intended to identify such forward-looking statements. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. SIGA’s actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA’s control, including, but not limited to, (i) the risk that BARDA elects, in its sole discretion as permitted under the BARDA Contract, not to exercise all, or any, of the remaining unexercised options under those contracts, (ii) the risk that SIGA may not complete performance under the BARDA Contract on schedule or in accordance with contractual terms, (iii) the risk that the BARDA Contract, DoD Contract #2 or PEP Label Expansion R&D Contract are modified or canceled at the request or requirement of the U.S. Government, (iv) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to continue to successfully market TPOXX® internationally, (v) the risk that potential products, including potential alternative uses or formulations of TPOXX® that appear promising to SIGA or its collaborators, cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (vi) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products or uses, (vii) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including intellectual property protection, (viii) the risk that any challenge to SIGA’s patent and other property rights, if adversely determined, could affect SIGA’s business and, even if determined favorably, could be costly, (ix) the risk that regulatory requirements applicable to SIGA’s products may result in the need for further or additional testing or documentation that will delay or prevent SIGA from seeking or obtaining needed approvals to market these products, (x) the risk that the volatile and competitive nature of the biotechnology industry may hamper SIGA’s efforts to develop or market its products, (xi) the risk that changes in domestic or foreign economic and market conditions may affect SIGA’s ability to advance its research or may affect its products adversely, (xii) the effect of federal, state, and foreign regulation, including drug regulation and international trade regulation, on SIGA’s businesses, (xiii) the risk of disruptions to SIGA’s supply chain for the manufacture of TPOXX®, causing delays in SIGA’s research and development activities, causing delays or the re-allocation of funding in connection with SIGA’s government contracts, or diverting the attention of government staff overseeing SIGA’s government contracts, (xiv) risks associated with actions or uncertainties surrounding the debt ceiling, (xv) the risk that the U.S. or foreign governments' responses (including inaction) to national or global economic conditions or infectious diseases, such as COVID-19, are ineffective and may adversely affect SIGA’s business, and (xvi) risks associated with responding to the current mpox outbreak, as well as the risks and uncertainties included in Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2022 and SIGA's subsequent filings with the Securities and Exchange Commission. SIGA urges investors and security holders to read those documents free of charge at the SEC's website at http://www.sec.gov.  All such forward-looking statements are current only as of the date on which such statements were made. SIGA does not undertake any obligation to update publicly any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events.
 
The information contained in this press release does not necessarily reflect the position or the policy of the Government and no official endorsement should be inferred.
 
Contacts:
 
Investor Contact
Laine Yonker, Edison Group
lyonker@edisongroup.com

Public Relations
Holly Stevens, Berry & Company
hstevens@berrypr.com

 

v3.23.2
Document and Entity Information
Jul. 27, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Jul. 27, 2023
Entity File Number 0-23047
Entity Registrant Name SIGA TECHNOLOGIES, INC.
Entity Central Index Key 0001010086
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 13-3864870
Entity Address, Address Line One 31 East 62nd Street
Entity Address, City or Town New York
Entity Address, State or Province NY
Entity Address, Postal Zip Code 10065
City Area Code 212
Local Phone Number 672-9100
Title of 12(b) Security common stock, $.0001 par value
Trading Symbol SIGA
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false

SIGA Technologies (NASDAQ:SIGA)
Historical Stock Chart
From Mar 2024 to Apr 2024 Click Here for more SIGA Technologies Charts.
SIGA Technologies (NASDAQ:SIGA)
Historical Stock Chart
From Apr 2023 to Apr 2024 Click Here for more SIGA Technologies Charts.