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): May 17, 2019
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
(Address of principal executive offices)
|
|
10065
(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))
|
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. ☐
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
|
Item 1.01. Entry into a Material Definitive Agreement.
On May 20, 2019, SIGA Technologies, Inc., a Delaware corporation (the
“Company”), announced the exercise of an option, optional procurement Contract Line Item Number (“CLIN”)
0009a (“Optional CLIN 0009a”), under its 2018 procurement contract (contract #HHSO100201800019C) with the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (the “2018 BARDA
Contract”). Optional CLIN 0009a, worth a total of approximately $11 million, is for the purchase of raw materials in sufficient quantity to support the manufacture of at least 363,070 courses of oral TPOXX, the Company’s antiviral treatment for
smallpox. The option exercise occurs simultaneously with a modification to the 2018 BARDA Contract (the “Modification”), in which optional CLIN 0009 (“Optional CLIN 0009”) was replaced with four new procurement-related options. Optional CLIN
0009a was one of these four new procurement-related options. Each of the other three new options, optional CLINs 0009b, 0009c, and 0009d, individually specify the delivery of approximately 121,000 courses of oral TPOXX worth approximately $34
million, and have not yet been exercised. Taken together, Optional CLIN 0009a and the unexercised optional CLINs 0009b, 0009c, and 0009d provide for the manufacturing and delivery of 363,070 courses of oral TPOXX with a total value of
approximately $112.5 million. The modification does not change the overall total potential value of the 2018 BARDA Contract, nor does it change the total amount to be paid in connection with the delivery of oral TPOXX courses originally
specified in Optional CLIN 0009.
The foregoing description is qualified in its entirety by reference to the Modification, a copy of which is attached as 10.1 to this
Form 8-K 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
|
|
Amendment of Solicitation/Modification of Contract 0002, dated May 17, 2019, to Agreement, dated September 10, 2018, between the Biomedical Advanced
Research and Development Authority of the United States Department of Health and Human Services and SIGA Technologies, Inc. (Certain portions of this exhibit have been omitted pursuant to Rule 601(b)(10) of Regulation S-K. The omitted
information is (i) not material and (ii) would likely cause competitive harm to the Company if publicly disclosed).
|
||
|
Press Release, dated May 20, 2019.
|
SIGNATURE
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: May 20, 2019
|
|
|
|
Exhibit 10.1
Certain portions of this exhibit have been omitted pursuant to Rule 601(b)(10) of Regulation S-K. The omitted
information is (i) not material and (ii) would likely cause competitive harm to the Company if publicly disclosed. Information that has been omitted has been noted in this document with a placeholder identified by the mark “[***]”.
|
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
|
1. CONTRACT ID CODE
|
PAGE OF PAGES
|
||||
|
1
|
2
|
|||||
|
2. AMENDMENT/MODIFICATION NO.
P00002
|
3. EFFECTIVE DATE
See Block 16C
|
4. REQUISITION/PURCHASE REQ. NO.
OS240160
|
5. PROJECT NO. (if applicable)
|
|||
|
6. ISSUED BY
|
CODE
|
HHS/OS/ASPR/BARDA
|
7. ADMINISTERED BY (if other than Item 6) CODE
|
ASPR-BARDA01
|
||
|
US DEPT OF HEALTH & HUMAN SERVICES
ASST SEC OF PREPAREDNESS & RESPONSE
ACQ MANAGEMENT, CONTRACTS, & GRANTS
O’NEILL HOUSE OFFICE BUILDING
Washington DC 20515
|
ASPR-BARDA
330 Independence Ave, SW, Rm G644
Washington, DC 20201
|
|||||
|
8. NAME AND ADDRESS OF CONTRACTOR (No., street, county,
State and ZIP Code)
SIGA TECHNOLOGIES, INC. 1385150
SIGA TECHNOLOGIES, INC.
31 East 62nd street
NEW YORK, NY 100658446
|
(x)
|
9A. AMENDMENT OF SOLICITATION NO.
|
||||
|
9B. DATED (SEE ITEM 11)
|
||||||
|
x
|
10A. MODIFICATION OF CONTRACT/ORDER NO.
HHSO100201800019C
|
|||||
|
CODE 1385150
|
FACILITY CODE
|
10B. DATED (SEE ITEM 13)
09/10/2018
|
||||
|
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
|
||||||
|
☐ The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of
Offers ☐ is extended. ☐ is not extended.
Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as
amended, by one of the following methods: (a) By completing Items 8 and 15, and returning ______ copies of the amendment, (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or
telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION
OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is
received prior to the opening hour and date specified.
|
||||||
|
12. ACCOUNTING AND APPROPRIATION DATA (if
required) 2019.1990051.25106
|
Net Increase:
|
$11,255,170.00
|
|
13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM
14.
|
|
|
CHECK
ONE
|
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.
|
|
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).
|
|
|
X
|
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
FAR 43.103(a) Bilateral Modification; FAR7.207(c)(1) Exercise of Options with Available Funds
|
|
D. OTHER (Specify type of
modification and authority)
|
|
|
E. IMPORTANT: Contractor ☐ is not. ☒ is required to sign this document and return 1 copies to
the issuing office.
|
|||
|
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized
by UCF section headings, including solicitation/contract subject matter where feasible.)
|
|||
|
Tax ID Number: 13-3864870
|
|||
|
DUNS Number: 932651516
|
|||
|
Procurement and Late-Stage Development of Smallpox Antiviral Drug(s)
|
|||
|
The purpose of this modification is to (1) exercise Option CLIN0009a in the amount of $11,255,170.00, (2) modify Article G.2. to change
the Contracting Officer’s Representative as follows; (3) revise Article B.3. to breakout CLIN0009 into four subparts (0009a, 0009b, 0009c, 0009d) as follows.
|
|||
|
All other terms and conditions in the contract remain unchanged.
Delivery: [***]
Continued …
|
|||
|
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore
changed, remains unchanged and in full force and effect.
|
|||
|
15A. NAME AND TITLE OF SIGNER (Type or print)
Dennis E. Hruby, CSO
|
16A. NAME AND TITLE OF CONTRACTING OFFICER (Type
or print)
Christopher Scott
|
||
|
15B. CONTRACTOR/OFFEROR
|
15C. DATE SIGNED
|
16B. UNITED STATES OF AMERICA
|
16C. DATE SIGNED
|
| /s/ Dennis E. Hruby |
16 May 2019 |
/s/ Christopher Scott
|
05/17/19
|
|
(Signature of person authorized to sign)
|
(Signature of Controlling Officer)
|
||
|
NSN 7540-01-152-8070
|
STANDARD FORM 30 (REV. 10-83)
|
|
Previous edition unusable
|
Prescribed by GSA
|
|
FAR (48 CFR) 53.243
|
|
CONTINUATION SHEET
|
REFERENCE NO. OF DOCUMENT BEING CONTINUED
HHSO100201800019C/P00002
|
PAGE OF
|
|
|
2
|
2
|
||
|
NAME OF OFFEROR OR CONTRACTOR
SIGA TECHNOLOGIES, INC. 1385150
|
|||||
|
ITEM NO
(A)
|
SUPPLIES/SERVICES
(B)
|
QUANTITY
(C)
|
UNIT
(D)
|
UNIT PRICE
(E)
|
AMOUNT
(F)
|
|
Delivery Location Code: HHS/OS/ASPR
HHS/OS/ASPR
200 C St. SW
WASHINGTON DC 20201 US
|
|||||
|
Appr. Yr.: 2019 CAN: 1990051 Object Class: 25106
Period of Performance: 09/10/2018 to 09/09/2028
|
|||||
|
Add Item 3 as follows:
|
|||||
|
3
|
ASPR-19-01762 – Exercise of Option CLIN 0009a to
SIGA Technologies for Procurement of raw
materials used in the manufacturing of
unmicronized API in sufficient quantity to support the production of 363,070 courses
of nonparenteral (oral) formulated antiviral for SNS replenishment. Such raw
materials may be forward processed, under contract HHSO100201800019C
Obligated Amount: $11,255,170.00
|
11,255,170.00
|
|||
|
|
|||||
| NSN 7540-01-152-8067 |
OPTIONAL FORM 336 (4-86)
Sponsored by GSA
FAR (48 CFR) 53.110
|
||||
Article B.3. OPTION PRICES
|
Modified
CLIN
|
Period of
Performance
|
Supplies/Services
|
Treatment
Courses (#
of Product)
|
Unit Price
($)
|
Total ($)
|
||||||
|
0009A
(Option -
EXERCISED)
|
[***]
|
Procurement of raw materials used in the manufacturing of unmicronized API in sufficient quantity to support the production of 363,070 courses of
nonparenteral (oral) formulated antiviral for SNS replenishment. Such raw materials may be forward processed.
|
363,070
(raw materials)
|
$31
|
$11,255,170
|
||||||
|
0009B
(Option)
|
[***]
|
Additional procurement of nonparenteral (oral) formulated
antiviral as FDP and delivery to the SNS
|
121,023
(finished product)
|
$279
|
$33,765,417
|
||||||
|
0009C
(Option)
|
[***]
|
Additional procurement of nonparenteral (oral) formulated
antiviral as FDP and delivery to the SNS
|
121,023
(finished product)
|
$279
|
$33,765,417
|
||||||
|
0009D
(Option)
|
[***]
|
Additional procurement of nonparenteral (oral) formulated
antiviral as FDP and delivery to the SNS
|
121,024
(finished product)
|
$279
|
$33,765,696
|
ARTICLE G.2. CONTRACTING OFFICER’S REPRESENTATIVE (COR)
The following Contracting Officer’s Representative (COR) will replace Claiborne Hughes and represent the Government for the purpose of this contract:
David Simon
Contracting Officer’s Representative
Biomedical Advanced Research and Development Authority (BARDA)
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
David.Simon@hhs.gov
202-260-1101
Exhibit 99.1
SIGA Announces Exercise of Option for the Purchase of Raw Materials for Oral TPOXX® Manufacturing
Totaling $11 Million
Raw Materials expected to be used to Support Manufacture of 363,070 Courses of Oral TPOXX
May 20, 2019
NEW YORK -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced the
exercise of an option under BARDA contract HHSO100201800019C (“2018 BARDA Contract”) worth a total of approximately $11 million for the purchase of raw materials in sufficient quantity to support the manufacture of at least 363,070 courses of
oral TPOXX. The option exercise occurs simultaneously with a modification to the 2018 BARDA Contract, in which optional procurement Contract Line Item Number (CLIN) 0009 (“Optional CLIN 0009”) was replaced with four new procurement-related
options. One of the four new procurement-related options, the aforementioned $11 million option (“Optional CLIN 0009a”), has been exercised. Each of the other three new options, optional CLINs 0009b-d, individually specify the delivery of
approximately 121,000 courses of oral TPOXX worth approximately $34 million. In total, optional CLINs 0009a (exercised), 0009b, 0009c and 0009d provide for the manufacturing and delivery of 363,070 courses of oral TPOXX with a total value of
approximately $112.5 million. The modification does not change the overall total potential value of the 2018 BARDA Contract, nor does it change the total amount to be paid in connection with the delivery of oral TPOXX courses originally
specified in Optional CLIN 0009.
“The execution of this option is an important step in the timely maintenance of the oral TPOXX stockpile for the US Government,” said Phil Gomez, CEO of SIGA
Technologies. “It provides meaningful cash funding to SIGA prior to delivery of final product, and reflects a shared focus on ensuring timely production of TPOXX to support stockpile maintenance.” Dr. Gomez further noted that “TPOXX
deliveries to the Strategic National Stockpile began in 2013, and the FDA approval of oral TPOXX in July of 2018 included a 7-year shelf life. In the Request For Proposal (‘RFP’) for the BARDA contract awarded to SIGA in 2018, BARDA indicated
that part of the intent of that RFP was to maintain a stockpile of 1.7 million courses of TPOXX. SIGA is committed to working with BARDA to achieve this goal and provide flexibility where necessary to ensure timely manufacture and delivery of
TPOXX.”
In its Form 10-K filed on March 5, 2019, SIGA also disclosed that BARDA has exercised CLIN 0007 to support the post-marketing commitments required by the U.S. Food
and Drug Administration (“FDA”) for oral TPOXX. The total value of this cost plus fixed-fee option (CLIN 0007) is approximately $12 million, and will support on-going activities required by FDA post-approval for oral TPOXX.
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 of which approximately 2 million oral courses have been delivered to the Strategic National
Stockpile under Project BioShield. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox on July 13, 2018. In September 2018, SIGA signed a new contract with Biomedical Advanced Research and Development Authority
(BARDA) 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 Smallpox1
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 the risk of the current vaccine's side effects is too high to justify routine vaccination for people at low risk of exposure to the smallpox virus.
FORWARD-LOOKING STATEMENTS
This press release contains certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended.
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. 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, 2018, and in other documents that SIGA has filed with the SEC. SIGA urges investors and security holders to read those documents free of charge at the SEC's web
site at http://www.sec.gov. Interested parties may also obtain those documents free of charge from SIGA. Forward-looking statements are current only as of the date on which such statements were made, and except for our ongoing obligations under
the United States of America federal securities laws, we undertake no obligation to update publicly any forward-looking statements whether as a result of new information, future events, or otherwise.
2
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:
Investors
David Carey
212-867-1768
dcarey@lazarpartners.com
Media
Stephanie Seiler
206-713-0124
sseiler@lazarpartners.com
|
1
|
http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769
|
3