UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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 25, 2023
(Exact name of registrant as specified in its charter)
Delaware |
001-37695 |
20-8436652 |
(State or other jurisdiction |
(Commission |
(IRS Employer |
of incorporation) |
File Number) |
Identification No.) |
219 Terry Ave. N., Suite 300 |
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Seattle, WA |
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98109 |
(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (206) 378-0400
Not Applicable
(Former name or former address, if changed since last report)
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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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 |
Name of each exchange |
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Symbol(s) |
on which registered |
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Common Stock, par value $0.001 per share |
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KA |
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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 1.01 Entry Into a Material Definitive Agreement.
Second Amendment to Option and License Agreement (VISTA)
As previously disclosed, on August 10, 2020, Kineta, Inc. (“Kineta” or the “Company”) entered into an option and license agreement with GigaGen, Inc. (“GigaGen”), which was amended on November 19, 2020 (such option and license agreement, as amended, the “VISTA Agreement”), to in-license certain intellectual property and antibodies for the VISTA/KVA12123 drug program. On May 25, 2023, Kineta and GigaGen entered into the Second Amendment to Option and License Agreement (the “Second Amendment to VISTA Agreement”) to, among other things, amend the development and regulatory milestone payments, sales milestone payments, and royalties under the VISTA Agreement. Pursuant to the Second Amendment to VISTA Agreement, GigaGen is eligible to receive less than $21 million in development and regulatory milestone payments and up to $11 million in sales milestone payments. In addition, GigaGen is eligible to receive low single-digit royalty percentages based on net sales. A copy of the Second Amendment to VISTA Agreement is attached hereto as Exhibit 10.1 and is incorporated herein by reference.
Third Amendment to Option and License Agreement (CD27)
As previously disclosed, on June 9, 2021, Kineta entered into an option and license agreement with GigaGen, which was amended on July 31, 2022 and December 21, 2022 (such option and license agreement, as amended, the “CD27 Agreement”), to in-license certain intellectual property and antibodies for the CD27 drug program. On May 25, 2023, Kineta and GigaGen entered into the Third Amendment to Option and License Agreement (the “Third Amendment to CD27 Agreement”) to, among other things, amend the upfront payment, development and regulatory milestone payments, sales milestone payments, and royalties under the CD27 Agreement. Pursuant to the Third Amendment to CD27 Agreement, upon Kineta’s exercise of the option, GigaGen will be eligible to receive an upfront payment of cash and equity and GigaGen will be eligible to receive less than $21 million in development and regulatory milestone payments and up to $11 million in sales milestone payments. In addition, GigaGen is eligible to receive low single-digit royalty percentages based on net sales. A copy of the Third Amendment to CD27 Agreement is attached hereto as Exhibit 10.2 and is incorporated herein by reference.
Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: May 30, 2023
Kineta, Inc.
By: |
/s/ Shawn Iadonato |
Name: |
Shawn Iadonato |
Title: |
Chief Executive Officer and Director |
EXHIBIT 10.1
Certain identified information in this document has been excluded because it is both (i) not material and (ii) the type that the registrant treats as private or confidential, and has been marked with “[***]” to indicate where omissions have been made.
SECOND AMENDMENT TO OPTION AND LICENSE AGREEMENT
This Second Amendment to Option and License Agreement (the “Amendment”), effective as of May 25, 2023 (the “Second Amendment Effective Date”) by and between GigaGen, Inc., a Delaware corporation having a place of business at 1 Tower Place, Suite 750, South San Francisco, CA 94080 (“GigaGen”) and Kineta, Inc., a Delaware corporation having a place of business at 219 Terry Avenue North, Suite 300, Seattle, WA 98109 on behalf of itself and its Affiliates (“Kineta”), amends that certain Option and License Agreement, dated August 10, 2020 by and between GigaGen and Kineta, as amended by that certain First Amendment to Option and License Agreement, dated November 19, 2020 (together, the “Agreement”). Each of GigaGen and Kineta shall be referred to herein individually as a “Party” and collectively as the “Parties”. Capitalized terms not defined herein shall have the same meanings as set forth in the Agreement.
NOW, THEREFORE, in consideration of the mutual promises set forth herein, the Parties hereby agree as follows
1. Sections 4.3, 4.4 and 4.5(a) of the Agreement is hereby amended by deleting in its entirety and replacing them with the following:
4.3 Development and Regulatory Milestone Payments. Kineta shall notify GigaGen within thirty (30) days after the first achievement of each milestone event in the table below by Kineta or its Affiliate or Sublicensee. Thereafter, GigaGen may invoice Kineta for the corresponding milestone payment, and Kineta shall pay such invoice within sixty (60) days after the achievement of such milestone event.
Development Milestone Event |
Milestone Payment |
Initiation of the Phase 1 Clinical Trial* of a Licensed Product |
[***] |
Initiation of the first Phase 2 Clinical Trial of a Licensed Product |
[***] |
Initiation of the first Pivotal Clinical Trial of a Licensed Product |
[***] |
First Regulatory Approval of a Licensed Product in the U.S. for a first Indication |
[***] |
Development Milestone Event |
Milestone Payment |
First Regulatory Approval of a Licensed Product in the U.S. for a second Indication |
[***] |
First Regulatory Approval of a Licensed Product in the U.S. for a third Indication |
[***] |
First approval of a BLA for a Licensed Product by the EMA |
[***] |
First approval of a BLA for a Licensed Product in Japan |
[***] |
* As used herein, the following terms shall have the following meaning, “Phase 1 Clinical Trial” means a study in humans of the safety and dose range of a Licensed Product that is designed to generate sufficient data to commence a Phase 2 Clinical Trial
For the purposes of clarification, each Option and License Agreement is a separate and distinct agreement for services between the parties. Payments (including but not limited to development milestone payments, commercialization milestone payments, and milestone payments) made under the terms of any Option and License Agreement shall not affect amounts owed under other existing or future Option and License Agreements. Each milestone payment set forth above shall be payable only once, regardless of the number of times the applicable milestone event is achieved by any Licensed Product and regardless of the number of Licensed Products to achieve the applicable milestone event under the terms of this Agreement. Under no circumstances shall Kineta be obligated to pay GigaGen more than twenty million and four hundred thousand Dollars ($20,400,000) under Section 4.3 of this Agreement.
4.4 Sales Milestone Payments. Kineta shall make the following milestone payments to GigaGen within ninety (90) days after the end of the calendar year in which the annual Net Sales by Kineta and its Affiliates and Sublicensees of all Licensed Products first reach each of the amounts specified below. Each such sales milestone payment shall be payable one time only.
Sales Milestone Event |
Milestone Payment |
The aggregate Net Sales of Licensed Products in the Territory in a calendar year exceed two hundred million Dollars ($200,000,000) |
[***] |
The aggregate Net Sales of Licensed Products in the Territory in a calendar year exceed five hundred million Dollars ($500,000,000) |
[***] |
The aggregate Net Sales of Licensed Products in the Territory in a calendar year exceed one billion Dollars ($1,000,000,000) |
[***] |
Under no circumstances shall Kineta be obligated to pay GigaGen more than eleven million Dollars ($11,000,000) pursuant to this Section 4.4.
4.5 Royalties.
2. Except as set forth herein, all other terms and conditions of the Agreement shall remain in full force and effect.
3. This Amendment may be signed in counterparts, each of which shall be an original, with the same effect as if the signatures were upon the same instrument.
[signature page follows]
IN WITNESS WHEREOF, duly authorized representatives of the Parties have duly executed this Amendment as of the Second Amendment Effective Date.
GigaGen, Inc. Kineta, Inc.
Signature: /s/ Carter Keller Signature: /s/ Craig Philips
Name: Carter Keller Name: Craig Philips
Title: SVP, Gigagen Title: President
Date: May 24, 2023 Date: May 25, 2023
EXHIBIT 10.2
Certain identified information in this document has been excluded because it is both (i) not material and (ii) the type that the registrant treats as private or confidential, and has been marked with “[***]” to indicate where omissions have been made.
THIRD AMENDMENT TO OPTION AND LICENSE AGREEMENT
This Third Amendment to Option and License Agreement (the “Amendment”), effective as of May 25, 2023 (the “Third Amendment Effective Date”) by and between GigaGen, Inc., a Delaware corporation having a place of business at 1 Tower Place, Suite 750, South San Francisco, CA 94080 (“GigaGen”) and Kineta, Inc., a Delaware corporation having a place of business at 219 Terry Avenue North, Suite 300, Seattle, WA 98109 on behalf of itself and its Affiliates (“Kineta”), amends that certain Option and License Agreement, dated June 9, 2021 by and between GigaGen and Kineta as amended by that certain First Amendment to Option and License Agreement, dated July 31, 2022 as further amended by the certain Second Amendment to Option and License Agreement, dated December 21, 2022 (together, the “Agreement”). Each of GigaGen and Kineta shall be referred to herein individually as a “Party” and collectively as the “Parties”. Capitalized terms not defined herein shall have the same meanings as set forth in the Agreement.
NOW, THEREFORE, in consideration of the mutual promises set forth herein, the Parties hereby agree as follows:
1. Sections 4.3, 4.4, 4.5 and 4.6 (a) of the Agreement are hereby amended by deleting in their entirety and replacing them with the following:
4.3 Upfront Payment. Within sixty (60) days after the Option Exercise Date, Kineta shall (i) pay to GigaGen a one-time upfront payment of [***] and (ii) issue to GigaGen, pursuant to Kineta’s standard form of stock issuance agreement to be entered into between the parties, shares of common stock of Kineta having an aggregate value (at the then-current fair market value) of [***].
4.4 Development and Regulatory Milestone Payments. Kineta shall notify GigaGen within thirty (30) days after the first achievement of each milestone event in the table below by Kineta or its Affiliate or Sublicensee. Thereafter, GigaGen may invoice Kineta for the corresponding milestone payment, and Kineta shall pay such invoice within the earlier of (i) thirty (30) days after Kineta’s receipt of GigaGen’s invoice to Kineta or (ii) sixty (60) days after the achievement of such milestone event.
Development Milestone Event |
Milestone Payment |
Initiation of the first Phase 1 Clinical Trial* of a Licensed Product |
[***] |
Development Milestone Event |
Milestone Payment |
Initiation of the first Phase 2 Clinical Trial of a Licensed Product |
[***] |
Initiation of the first Pivotal Clinical Trial of a Licensed Product |
[***] |
First Regulatory Approval of a Licensed Product in the U.S. for a first Indication |
[***] |
First Regulatory Approval of a Licensed Product in the U.S. for a second Indication |
[***] |
First Regulatory Approval of a Licensed Product in the U.S. for a third Indication |
[***] |
First approval of a BLA for a Licensed Product by the EMA |
[***] |
First approval of a BLA for a Licensed Product in Japan |
[***] |
* As used herein, the following terms shall have the following meaning, “Phase 1 Clinical Trial” means a study in humans of the safety and dose range of a Licensed Product that is designed to generate sufficient data to commence a Phase 2 Clinical Trial
For the purposes of clarification, each Option and License Agreement is a separate and distinct agreement for services between the parties. Payments (including but not limited to development milestone payments, commercialization milestone payments, and milestone payments) made under the terms of any Option and License Agreement shall not affect amounts owed under other existing or future Option and License Agreements. Each milestone payment set forth above shall be payable only once, regardless of the number of times the applicable milestone event is achieved by any Licensed Product and regardless of the number of Licensed Products to achieve the applicable milestone event under the terms of this Agreement. Under no circumstances shall Kineta be obligated to pay GigaGen more than twenty million and four hundred thousand Dollars ($20,400,000) under Section 4.4 of this Agreement.
4.5 Sales Milestone Payments. Kineta shall make the following milestone payments to GigaGen within ninety (90) days after the end of the calendar year in which the annual Net Sales by Kineta and its Affiliates and Sublicensees of all Licensed Products first reach each of the amounts specified below. Each such sales milestone payment shall be payable one time only.
Sales Milestone Event |
Milestone Payment |
The aggregate Net Sales of Licensed Products in the Territory in a calendar year exceed two hundred million Dollars ($200,000,000) |
[***] |
The aggregate Net Sales of Licensed Products in the Territory in a calendar year exceed five hundred million Dollars ($500,000,000) |
[***] |
The aggregate Net Sales of Licensed Products in the Territory in a calendar year exceed one billion Dollars ($1,000,000,000) |
[***] |
Under no circumstances shall Kineta be obligated to pay GigaGen more than eleven million Dollars ($11,000,000) pursuant to this Section 4.3.
4.6 Royalties.
2. Except as set forth herein, all other terms and conditions of the Agreement shall remain in full force and effect.
3. This Amendment may be signed in counterparts, each of which shall be an original, with the same effect as if the signatures were upon the same instrument.
[signature page follows]
IN WITNESS WHEREOF, duly authorized representatives of the Parties have duly executed this Amendment as of the Third Amendment Effective Date.
GigaGen, Inc. Kineta, Inc.
Signature:/s/ Carter Keller Signature: /s/ Craig Philips
Name: Carter Keller Name: Craig Philips
Title: SVP, GigaGen Title: President
Date: May 24, 2023 Date: May 25, 2023