UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 1.01. Entry into a Material Definitive Agreement.
On March 3, 2025, Cadrenal Therapeutics, Inc. (the “Company”) entered into a Collaboration Agreement (the “Collaboration Agreement”) with Abbott Global Enterprises Limited (“Abbott”) to collaborate on the Phase 3 randomized, warfarin-controlled, multicenter study with an open-label extension being sponsored by the Company, named “TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices” (the “Study”), to evaluate the efficacy and safety of tecarfarin in patients with a left-ventricular assist device (“the “Study Device”).
Pursuant to the Collaboration Agreement, Abbott will share with the Company data collected by it on the LVAD population via its MOMENTUM 3 and ARIES HM3 US IDE trials and further grant the Company a non-exclusive, limited, non-transferable, non-sublicensable license to use the data for the purposes of the Company’s Study, including support for protocol development, as well as regulatory submissions related to the Study. The Company shall be the regulatory sponsor of the Study and shall have the obligations of the sponsor pursuant to applicable laws, including, without limitation, monitoring of the Study and interacting with regulatory authorities with respect to the Study. The Company is pursuing business development strategies, including licenses and funding partnerships, to support funding the Phase 3 study.
The Collaboration Agreement further provides that the Company and Abbott will collaborate in the following areas: (1) Biostatistics including Statistical Analysis Plan development, (2) Site and investigator selection, (3) Site qualification/feasibility, (4) Patient identification and recruitment, and (5) Medical science liaison support.
The Collaboration Agreement provides that the Company will own the Study data and grant Abbott a non-exclusive, royalty-free license to use the Study data for research and development purposes relating to Abbott’s products. The Collaboration Agreement further provides that intellectual property unrelated to the Study Device that is conceived, first reduced to practice or created solely by the Company in connection with the Study pursuant to the Collaboration Agreement, will be the sole property of the Company and intellectual property unrelated to tecarfarin that is conceived, first reduced to practice or created solely by Abbott in connection with the Study pursuant to the Collaboration Agreement, will be the sole property of the Abbott. The Collaboration Agreement also provides that intellectual property conceived, first reduced to practice or created by either Abbott or the Company as a result of or in connection with the Study under the Collaboration Agreement, and that (i) uses, incorporates, or directly relates to tecarfarin, and (ii) does not use, incorporate, or directly relate to the Study Device will be the sole property of the Company. Any intellectual property conceived, first reduced to practice or created by either Abbott or the Company in connection with the Study pursuant to the Collaboration Agreement, and that uses, incorporates, or otherwise directly relates to the Study Device and does not use, incorporate, or directly relate to tecarfarin will be the sole property of Abbott. The Collaboration Agreement further provides that the data from the Study may not be used by Abbott to develop or commercialize any other anticoagulant except when working on the Study Device.
Either party may terminate the Collaboration Agreement without cause upon sixty days written notice to the other party and immediately upon a material breach by the other party of any provision of the Collaboration Agreement.
The foregoing description of the Collaboration Agreement does not purport to be complete and is qualified in its entirety by reference to the Collaboration Agreement, a copy of which is filed as Exhibit 10.1 hereto and incorporated by reference herein.
Item 8.01. Other Events.
On March 4, 2025, the Company issued a press release announcing the entry into the Collaboration Agreement above. The press release issued in connection with this announcement is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference.
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following exhibits are furnished with this Current Report on Form 8-K:
| Exhibit Number |
Exhibit Description | |
| 10.1 | Collaboration Agreement between Abbott Global Enterprises Limited and Cadrenal Therapeutics, Inc. | |
| 99.1 | Press Release, issued by Cadrenal Therapeutics, Inc. on March 4, 2025 | |
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within in the inline XBRL document) |
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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.
| Dated: March 4, 2025 | CADRENAL THERAPEUTICS, INC. | |
| By: | /s/ Quang Pham | |
| Name: | Quang Pham | |
| Title: | Chairman and Chief Executive Officer | |
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