Keros Therapeutics Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Other Events, Financial Statements and Exhibits
$KROS
Biotechnology: Pharmaceutical Preparations
Health Care
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): December 3, 2024
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Item 1.01 Entry into a Material Definitive Agreement.
On December 3, 2024, Keros Therapeutics, Inc. (the “Company”) entered into an Exclusive License Agreement (the “Agreement”) with Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”). Under the terms of the Agreement, the Company has granted Takeda the exclusive right to develop, manufacture, and commercialize the Company’s product candidate, elritercept (KER-050), and certain derivative compounds. This exclusive right applies globally, excluding the territories of mainland China, Hong Kong, and Macau (the “Territory”).
Under the Agreement, Takeda will make an upfront payment to the Company of $200.0 million. In addition to the upfront payment, the Company is entitled to receive up to an aggregate of (i) $370.0 million upon the achievement of specified development and commercial milestones; and (ii) $740.0 million upon the achievement of specified sales milestones. If a licensed product is approved for marketing in the Territory, the Company will be entitled to receive royalty payments based on tiered increments of annual net sales in the Territory, with such percentage ranging from the low double-digits to high teens, subject to specified potential royalty reductions.
Takeda’s obligation to pay royalties for a given licensed product in a given country in the Territory will begin on the date of the first commercial sale for such licensed product in such country and continue until the latest of (i) 10 years from the date of the first commercial sale for such licensed product in such region, (ii) the expiration of the last valid claim of certain licensed patents, and (iii) expiration of regulatory exclusivity in such region.
The Agreement will continue in force until the expiration of the royalty term. Takeda may terminate the Agreement (i) in its entirety or on a country-by-country basis for convenience, with notice or (ii) if Takeda reasonably determines that the development, manufacture, and commercialization of the licensed compound or licensed product pose a safety or public health risk. The Company may terminate the Agreement in its entirety in the event that Takeda or its affiliates bring a patent challenge. Either party may terminate the Agreement in its entirety (i) if antitrust clearance is not obtained within a specified period after the Effective Date; (ii) if the other party materially breaches the Agreement and fails to cure such breach; or (iii) upon the bankruptcy of the other party.
The foregoing summary of the Agreement is not complete and is qualified in its entirety by reference to the text of the Agreement, a copy of which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ending December 31, 2024.
Item 8.01 Other Events.
On December 3, 2024, the Company issued a press release announcing it entered into the Agreement with Takeda. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit | ||||||||
| No. | Description | |||||||
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL document) | |||||||
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.
| KEROS THERAPEUTICS, INC. | ||||||||
| By: | /s/ Jasbir Seehra | |||||||
Jasbir Seehra, Ph.D. Chief Executive Officer | ||||||||
Dated: December 3, 2024