Kiniksa Pharmaceuticals International plc filed SEC Form 8-K: Termination of a Material Definitive Agreement, Results of Operations and Financial Condition, Costs Associated with Exit or Disposal Activities, Financial Statements and Exhibits
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Item 1.02. Termination of a Material Definitive Agreement.
On February 21, 2025, a wholly-owned subsidiary of Kiniksa Pharmaceuticals International, plc (together, with its consolidated subsidiaries, the “Company”) provided written notice to MedImmune, Limited (“MedImmune”) that, in connection with the Company’s decision to terminate development of mavrilimumab, the Company has elected to terminate the license agreement by and between the Company and MedImmune, dated as of December 21, 2017 (as amended, the “MedImmune License Agreement”). The Company exercised its right to terminate the MedImmune License Agreement for convenience and, in accordance with the terms of the MedImmune License Agreement, the termination will be effective on May 22, 2025 (the “Termination Effective Date”).
Under the terms of the MedImmune License Agreement, MedImmune granted the Company an exclusive, sublicensable, worldwide license to certain intellectual property rights to make, use, develop and commercialize mavrilimumab and any other product containing an antibody to the GM-CSF receptor alpha that is covered by certain MedImmune patent rights for all indications, which license will terminate as of the Termination Effective Date.
The foregoing description of the MedImmune License Agreement is subject to and qualified in its entirety by the full text of the agreement, which was filed as Exhibit 10.8 to the Company’s Registration Statement on Form S-1 filed with the Securities and Exchange Commission (the “SEC”) on April 27, 2018, and Amendment No. 1 to MedImmune License Agreement, dated July 9, 2020, which was filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on July 15, 2020, each of which is incorporated by reference into this Item 1.02.
Item 2.02. Results of Operations and Financial Condition.
On February 25, 2025, the Company issued a press release announcing financial results for the fiscal year ended December 31, 2024. A copy of the press release is furnished with this Current Report on Form 8-K as Exhibit 99.1.
Item 2.05. Costs Associated with Exit or Disposal Activities.
On February 24, 2025, in light of the Company’s strategic reprioritization of its portfolio and certain capital allocation considerations, the Company committed to a plan to discontinue its Phase 2b clinical trial of abiprubart in Sjögren’s Disease. The Company expects to immediately end enrollment and initiate winddown activities for the clinical trial, with full completion of winddown activities expected to occur by the end of 2025.
As a result of the termination of the Phase 2b clinical trial, the Company has incurred approximately $19 million in expenses and expects to record approximately $14 million to $17 million in additional expenses, almost entirely consisting of expenses related to contract termination costs for the Company’s clinical supply agreements for abiprubart, with additional de minimis costs related to trial closeout activities. The Company plans to record such expenses as research and development expenses, and expects that the vast majority of these charges will be recorded in the periods covering the fourth quarter of 2024 and the first half of 2025.
The costs that the Company expects to incur in connection with the foregoing are subject to a number of assumptions, and actual results may materially differ. The Company may also incur other costs or charges not currently contemplated as a result of, or associated with, the foregoing events.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Earnings Press Release issued by Kiniksa Pharmaceuticals International, plc, dated February 25, 2025 | |
| 104 | Cover Page Interactive Data File (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.
| KINIKSA PHARMACEUTICALS INTERNATIONAL, PLC | ||
| Date: February 25, 2025 | By: | /s/ Madelyn Zeylikman |
| Madelyn Zeylikman | ||
| Senior Vice President, General Counsel and Secretary | ||