NKGen Biotech Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Regulation FD Disclosure, Financial Statements and Exhibits
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Item 1.01. Entry into a Material Definitive Agreement.
Heka Securities Purchase Agreement
On July 14, 2025, NKGen Biotech, Inc. (the “Company”) entered into a Collaboration Agreement (the “Agreement”) with HekaBio K.K. (“HekaBio”). Pursuant to the Agreement, the Company and HekaBio established a collaboration for the development, manufacturing, and commercialization of the Company’s SNK01 autologous enhanced natural killer cell therapy (the “Product”) for central nervous system and autoimmune & inflammatory conditions in Japan and other jurisdictions as may be agreed by the Company and HekaBio (the “Territory”). Pursuant to the Agreement, HekaBio will have exclusive rights to commercialize the Product in the Territory and assumes responsibility for all regulatory activities in the Territory, including acting as the Marketing Authorization Holder (as defined in the Agreement). Additionally, the Agreement provides for the supply of the Product by the Company at no cost for clinical trials and at a price to be agreed in a supply agreement until the development of in-Territory manufacturing capacity. HekaBio will be responsible for developing manufacturing capacity for the Product in the Territory. The Company and HekaBio will establish a Joint Steering Committee to oversee, exchange information, provide advice and facilitate successful cooperation under the Agreement.
Pursuant to the Agreement, the Company and HekaBio will share profits from the commercialization of the Product in the Territory. Initially, HekaBio will receive 70% of Systemwide Product Net Profits (as defined in the Agreement) until it has recovered its documented clinical trial and manufacturing costs, after which HekaBio will receive 45% and the Company will receive 55% of such profits.
The Agreement has an initial term of 15 years and will automatically renew for additional 5-year periods unless either the Company or HekaBio provides written notice of its intention not to renew the Agreement at least six months prior to the end of the then-current term. Pursuant to the Agreement, the Company also retains the right, at any time during the term of the Agreement, to initiate a buy-out option (the “Buy-Out”) under certain circumstances, including a change of control or to enable a third-party license inconsistent with HekaBio’s exclusive rights. The Buy-Out amount will be the greater of (i) 6.5 times HekaBio’s unrecovered costs or (ii) 6.5 times HekaBio’s share of the most recent 12-month Systemwide Product Net Profits (as defined in the Agreement).
The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 7.01 Regulation FD Disclosure
On July 17, 2025, the Company issued a press release regarding the Agreement. A copy of the press release is attached hereto as Exhibit 99.1.
The information presented in Item 7.01 of this Current Report on Form 8-K and the accompanying press release shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, unless the Company specifically states that the information is to be considered “filed” under the Exchange Act or specifically incorporates it by reference into a filing under the Securities Act or the Exchange Act.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits.
| Exhibit No. | Description | |
| 10.1 | Collaboration Agreement, dated July 14, 2025, by and between NKGen Biotech, Inc. and HekaBio K.K. | |
| 99.1 | Press release, dated July 17, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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SIGNATURES
Pursuant to the requirements of Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| NKGEN BIOTECH, INC. | ||
| Date: July 17, 2025 | /s/ Paul Y. Song | |
| Name: | Paul Y. Song | |
| Title: | Chief Executive Officer | |
| (Principal Executive Officer) | ||
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