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): June 20, 2025
_______________________________
Arbutus Biopharma Corporation
(Exact name of registrant as specified in its charter)
_______________________________
| British Columbia, Canada | 001-34949 | 98-0597776 |
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
701 Veterans Circle
Warminster, Pennsylvania 18974
(Address of Principal Executive Offices) (Zip Code)
(267) 469-0914
(Registrant's telephone number, including area code)
(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:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | 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 Symbol(s) | Name of each exchange on which registered |
| Common Shares, without par value | ABUS | The Nasdaq Stock Market LLC |
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. ☐
In December 2021, Arbutus Biopharma Corporation (“Arbutus”) entered into a technology transfer and license agreement (the “License Agreement”) with Qilu Pharmaceutical Co., Ltd. (“Qilu”), pursuant to which Arbutus granted Qilu an exclusive (except as to certain retained rights), sublicensable, royalty-bearing license, under certain intellectual property owned by Arbutus, to develop, manufacture and commercialize its lead compound, imdusiran, in China, Hong Kong, Macau and Taiwan (“Greater China and Taiwan”).
In light of Qilu’s pipeline reprioritization efforts and Arbutus’ renewed focus on advancing its pipeline efficiently, on June 20, 2025, Arbutus and Qilu mutually agreed to conclude the strategic partnership and entered into a Termination Agreement filed herewith as Exhibit 10.1. There were no payments associated with the termination and all rights granted under the License Agreement for imdusiran in Greater China and Taiwan have reverted to Arbutus.
The foregoing summary of the material terms of the License Agreement is qualified in its entirety by the complete terms and conditions of the License Agreement, filed with the Securities and Exchange Commission on March 3, 2022 as Exhibit 10.41 to Arbutus’ Annual Report on Form 10-K for the year ended December 31, 2021.
On June 25, 2025, Arbutus issued a press release announcing the reacquisition of imdusiran rights in Greater China and Taiwan, the termination of the License Agreement with Qilu, and its new Scientific Advisory Board. A copy of the press release is filed herewith as Exhibit 99.1 and is incorporated by reference herein.
(d) Exhibits.
| Exhibit Number | Description | |||
| 10.1† | Termination Agreement, dated June 20, 2025, by and between Arbutus Biopharma Corporation and Qilu Pharmaceutical Co., Ltd. | |||
| 99.1 | Press Release dated June 25, 2025 | |||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
† Certain confidential portions of the agreement were omitted by means of marking such portions with brackets (due to the registrant customarily and actually treating such information as private or confidential and such omitted information not being material) pursuant to Item 601 of Regulation S-K promulgated by the SEC. Arbutus agrees to supplementally furnish a copy of any confidential portions to the SEC upon request.
SIGNATURE
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.
| Arbutus Biopharma Corporation | ||
| Date: June 25, 2025 | By: | /s/ Tuan Nguyen |
| Tuan Nguyen | ||
| Chief Financial Officer | ||
EXHIBIT 10.1
TERMINATION AGREEMENT
This TERMINATION AGREEMENT (this “Termination Agreement”) is entered into as of as of the 20th day of June, 2025 (the “Termination Agreement Effective Date”), by and among Arbutus Biopharma Corporation, a British Columbia corporation (“Arbutus”), having a place of business at 701 Veterans Circle, Warminster, PA 18974, USA, and Qilu Pharmaceutical Co., Ltd., a company established pursuant to applicable laws and regulations of the People’s Republic of China (“Qilu”), having a place of business at No. 8888 Lvyou Road, Jinan, Shandong 250104 China. Arbutus and Qilu are each referred to herein by name or as a “Party” or, collectively, as “Parties”. Capitalized terms used but not defined herein shall have the meanings ascribed to them in the License Agreement (defined below).
RECITALS
WHEREAS, the Parties entered into that certain Technology Transfer and Exclusive License Agreement, by and among Arbutus and Qilu, dated December 13, 2021 (the “License Agreement”); and
WHEREAS, Qilu and Arbutus wish to terminate the License Agreement and the Ancillary Agreements (each as defined below) in their entirety, subject to the terms and conditions herein.
NOW THEREFORE, in consideration of the foregoing and the premises and conditions set forth herein, the Parties agree as follows:
| 1. | Termination. |
The License Agreement and each of the agreements listed on Exhibit A (the “Ancillary Agreements”) attached hereto (the License Agreement and the Ancillary Agreement are collectively referred as the “Terminated Agreements”) are hereby terminated as of the Termination Agreement Effective Date, except for the sections in such agreements that shall survive in accordance with the survival provisions thereof. For the avoidance of doubt, the Parties acknowledge and agree that Sections 12.3(a), 12.3(b), 12.5 and 12.6 of the License Agreement (and any other Sections referenced therein) govern the termination of the License Agreement.
| 2. | Effects of Termination |
| 2.1 | Generally |
| (i) | All licenses and other rights granted by Arbutus to Qilu are terminated, and all rights of Qilu under the Arbutus IP revert to Arbutus. Qilu acknowledges and agrees that (A) the license granted by Qilu to Arbutus under Section 11.1(c) of the License Agreement survives according to the terms of Section 12.3 thereof, and (B) Arbutus hereby requests, and Qilu hereby grants, the license set forth in Section 12.3(b)(ii) of the License Agreement pursuant to the terms therein. |
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***]”, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL
| (ii) | Other than as provided for or referenced in this Termination Agreement and/or Section 12.3 of the License Agreement, the Parties shall have no further obligation to perform any activities under the Terminated Agreements, and Qilu shall cease any and all Exploitation activities relating to the Licensed Compound and the Licensed Product in the Territory immediately. |
| 2.2 | Destruction of Material, Document and Confidential Information |
| (i) | Qilu shall, within thirty (30) days from Termination Agreement Effective Date, at Qilu’s sole cost and expense, destroy or delete, any and all documents containing the Arbutus Know-How that were provided by Arbutus under the Terminated Agreements and any unused tangible materials that were furnished by Arbutus under the Terminated Agreements, including those tangible materials set forth on Exhibit C hereto. |
| (ii) | Subject to Section 4.1(e) of the License Agreement and Section 2.3 below, within thirty (30) days from Termination Agreement Effective Date, each Party shall, at its own cost, destroy or delete all Confidential Information of the other Party received during the Term of the License Agreement, provided that each Party may retain the Confidential Information of the other Party as described and pursuant to the requirements set forth in Section 8.3 of the License Agreement, including that both Parties shall remain subject to the confidentiality obligations of Article 8 of the License Agreement with respect to such retained Confidential Information. Promptly after the destruction and/or deletion of Arbutus Confidential Information as set forth above, Qilu shall provide a written certification, signed by an authorized officer of Qilu, of such destruction and/or deletion. Notwithstanding the above, the parties agree that Qilu’s obligations under Section 4.1(e) of the License Agreement to maintain records shall expire five (5) years after the Termination Agreement Effective Date. |
| 2.3 | Data and Documents to be Transferred to Arbutus by Qilu. |
| (i) | Pursuant to Section 12.3(b)(i) of the License Agreement, Qilu hereby assigns any and all Regulatory Documents to Arbutus and shall transfer such Regulatory Documents, including any correspondence with Regulatory Authorities, as set forth below. |
| (ii) | To the extent permissible under Applicable Law, Arbutus shall be entitled to freely use the Product Data, including for the Exploitation of the Licensed Compound and Licensed Products. |
| (iii) | The transfer of electronic data and documents under this Termination Agreement, including the data and documents set forth on Exhibit D hereto, shall be effected by way of [***] mutually agreeable to the Parties and/or [***], promptly after execution of this Termination Agreement, but in no event later than June 30, 2025. |
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***]”, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL
| (iv) | For the documents written in Chinese, Qilu shall not be obligated to translate them into English. |
| 3. | [***] |
| 4. | Miscellaneous |
| 4.1 | This Termination Agreement may not be assigned or otherwise transferred by a Party, nor may any right or obligation hereunder be assigned or transferred by a Party, without the prior written consent of the other Party, provided that this Termination Agreement may be assigned by such Party without such consent in connection with a permitted assignment by such Party of the License Agreement in its entirety as set forth in Section 13.2 of the License Agreement. Notwithstanding any assignment or transfer pursuant to this Section 4, the assigning or transferring Party shall remain liable for all of its obligations hereunder. Any attempted assignment or transfer in violation of this Section 4.1 will be void and of no effect. |
| 4.2 | This Termination Agreement shall not be amended in any respect whatsoever except by a further agreement, in writing, fully executed by each of the Parties. |
| 4.3 | Qilu acknowledges and agrees that Arbutus may (i) release a press release announcing the termination of the Terminated Agreements using the language substantially in the form attached hereto as Exhibit B, and (ii) file with the United States Securities and Exchange Commission (SEC) any required disclosure related to the termination of the Terminated Agreements as long as it is consistent with the press release language in Exhibit B. Qilu acknowledges and agrees that such press release and SEC filing may include other disclosures unrelated to Qilu and the Terminated Agreements. Subject to Section 8.6 of the License Agreement, any other press release or other public disclosure concerning the termination hereunder shall be subject to the prior written consent of the Parties. The Parties agree to consult with each other reasonably and in good faith with respect to the text and timing of any other press releases and disclosures prior to the issuance thereof, and shall give due consideration to any reasonable comments by either Party relating to such releases and disclosures. |
| 4.4 | Article 8 (Confidentiality; Publication), Sections 13.1 (Force Majeure), 13.3 (Severability), 13.4 (Notices), 13.5 (Governing Law), 13.6 (Internal Resolution), 13.7 (Binding Arbitration), 13.8 (Headings), 13.9 (Independent Contractors), 13.10 (Waiver), 13.11 (Waiver of Rule of Construction), 13.13 (Business Day Requirements), 13.14 (Further Actions), and 13.15 (Construction) of the License Agreement are hereby incorporated herein by reference, mutatis mutandis. |
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***]”, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL
| 4.5 | This Termination Agreement may be executed in one or more counterparts, and by the Parties on separate counterparts, but shall not be effective until each Party has executed at least one counterpart and each such counterpart shall constitute an original of this Termination Agreement but all the counterparts shall together constitute one and the same instrument. Each counterpart may be executed by each of the Parties and transmitted by hand or electronic mail transmission, and shall be as valid and effectual as if executed as an original. The Parties agree that such transmission by hand or electronic mail shall be sufficient to constitute formal delivery of this Termination Agreement to the other Party. |
[Signature Page and Exhibits Follow]
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***]”, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL
In Witness Whereof, the Parties intending to be bound have caused this Termination Agreement to be executed by their duly authorized representatives as of the Termination Agreement Effective Date.
| ARBUTUS BIOPHARMA CORPORATION | ||
| By: | /s/ Lindsay Androski | |
| Name: | Lindsay Androski | |
| Title: | Chief Executive Officer | |
| QILU PHARMACEUTICAL CO., LTD. | ||
| By: | /s/ Yidong Zhu | |
| Name: | Yidong Zhu | |
| Title: | Executive Vice General Manager, Global Innovative R&D | |
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***]”, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL
Exhibit A
Ancillary Agreements
Exhibit B
Press Release Language
Exhibit C
Tangible Materials to be Destroyed by Qilu
Exhibit D
Documents and Data to be Transferred to Arbutus
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***]”, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL
EXHIBIT 99.1
Arbutus Reacquires Greater China Rights to Imdusiran and Announces Scientific Advisory Board with Late-Stage Clinical Focus
Qilu Pharmaceutical and Arbutus mutually agree to conclude strategic partnership for imdusiran in Greater China
Drs. Jordan Feld, Ed Gane, Anna Lok, Mark Sulkowski and Man-Fung Yuen
join Arbutus Scientific Advisory Board
WARMINSTER, Pa., June 25, 2025 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company focused on infectious disease, today announced that it has reacquired China rights to its lead compound, imdusiran, from Qilu Pharmaceutical, one of the leading pharmaceutical companies in China. The parties have mutually agreed to conclude the strategic partnership entered into in 2021 for development, manufacturing and commercialization of imdusiran in mainland China, Hong Kong, Macau and Taiwan markets.
“I would like to express our deepest thanks to the executive leadership and team at Qilu for the collaborative and fruitful partnership we have enjoyed over the last several years,” said Lindsay Androski, President and Chief Executive Officer of Arbutus. “In light of Qilu’s pipeline reprioritization efforts and Arbutus’ renewed focus on advancing our pipeline efficiently, the parties have agreed to terminate our strategic partnership for Greater China. We are thrilled to once again hold global rights for imdusiran, which to date has achieved functional cure in eight patients in combination therapy in two Phase 2a trials.”
Dr. Weikang Tao, the global R&D head of Qilu Pharmaceutical commented: “We greatly appreciate the collaboration, efforts and support of both Arbutus and Qilu's project teams for the development of imdusiran in the Greater China area and we wish Arbutus every success in further advancing the development of imdusiran.”
Arbutus has also launched a new Scientific Advisory Board (SAB) consisting of globally recognized leaders in the treatment of chronic hepatitis B virus (cHBV) with extensive experience in late-stage clinical trials. SAB members will advise Arbutus on its strategic evaluation of its cHBV pipeline. Members of Arbutus’ Scientific Advisory Board include:
As previously reported, to date, across all Phase 2a clinical trials (IM-PROVE I and IM-PROVE II) conducted with imdusiran, Arbutus has reported a total of 8 patients who have been functionally cured and were able to discontinue all therapies including nucleos(t)ide analogue (NA) therapy. Two of the patients who achieved functional cure received no interferon (IFN) as part of their treatment, and seven of the eight patients had baseline hepatitis B surface antigen (HBsAg) levels less than 1000 IU/mL.
About Imdusiran (AB-729)
Imdusiran is an RNAi therapeutic specifically designed to reduce all HBV viral proteins and antigens including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to control the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology enabling subcutaneous delivery. To date, Arbutus has reported a total of eight patients with cHBV who have achieved functional cure following treatment with imdusiran and NA therapy in combination with either IFN or low dose nivolumab plus an immunotherapeutic. Clinical data generated thus far has shown imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in HBsAg and hepatitis B virus DNA.
About HBV
Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from chronic HBV infection. Approximately 1.1 million people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options.
About Arbutus
Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company focused on infectious disease. The company is currently developing imdusiran (AB-729) and an oral PD-1 inhibitor (AB-101) for the treatment of chronic HBV infection. The Company is also consulting closely with and supporting its exclusive licensee, Genevant Sciences, to protect and defend its intellectual property, which is the subject of on-going lawsuits against Moderna and Pfizer/BioNTech for use of Arbutus’s patented LNP technology in their COVID-19 vaccines. For more information, visit www.arbutusbio.com.
Forward-Looking Statements and Information
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, forward-looking statements). Forward-looking statements in this press release include statements about: the potential to lead to a functional cure for HBV; the potential for Arbutus’ product candidates to achieve success in clinical trials; and Arbutus’ pipeline and development plans for its cHBV programs.
With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies. Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: ongoing and anticipated clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested product candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ products; economic and market conditions may worsen; and market shifts may require a change in strategic focus.
A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’ continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
Arbutus Biopharma Corporation / ir@arbutusbio.com