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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): July 30, 2025
VIRIDIAN THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-36483 | 47-1187261 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| 221 Crescent Street, Suite 103A Waltham, MA |
02453 | |||
| (Address of principal executive offices) | (Zip Code) | |||
Registrant’s telephone number, including area code: (617) 272-4600
N/A
(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 |
Name of each exchange on which registered |
||
| Common Stock, $0.01 par value | VRDN | 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. ☐
| Item 1.01 | Entry into Material Definitive Agreements. |
Collaboration and License Agreement
On July 30, 2025, Viridian Therapeutics, Inc. (the “Company”) and Kissei Pharmaceutical Co., Ltd. (“Kissei”) entered into a Collaboration and License Agreement (the “Collaboration Agreement”) pursuant to which the Company granted to Kissei an exclusive license to develop and commercialize products containing veligrotug and VRDN-003, each differentiated humanized monoclonal antibodies targeting IGF-1R for potential treatments, including treatment of thyroid eye disease, in Japan, and a non-exclusive license to manufacture such licensed products worldwide for use in Japan under certain limited circumstances.
Under the terms of the Collaboration Agreement, the Company will receive an upfront payment of $70.0 million, and will be eligible to receive up to an additional $315.0 million upon the achievement of certain development, regulatory and sales milestones. The Company will also receive tiered royalties in percentages ranging from the twenties to the mid-thirties based on future net sales of licensed products as set forth in the Collaboration Agreement.
Kissei will be responsible for developing and seeking regulatory approval of the licensed products in Japan, subject to oversight from a joint steering committee. Following regulatory approval, Kissei will be responsible for commercializing the licensed products in Japan. Except in certain limited circumstances, the Company will be responsible for manufacturing and supplying the licensed products for Kissei’s developmental and commercial use in Japan.
The term of the Collaboration Agreement will expire in its entirety upon the expiration of the royalty term for all licensed products and satisfaction of certain payment obligations as set forth in the Collaboration Agreement, unless earlier terminated by the parties in accordance with the terms of the Collaboration Agreement.
The foregoing description of the terms of the Collaboration Agreement is not complete and is qualified in its entirety by reference to the text of the Collaboration Agreement, a copy of which the Company intends to file as an exhibit to its Quarterly Report on Form 10-Q for the period ended September 30, 2025.
| Item 7.01 | Regulation FD Disclosure |
On July 30, 2025, the Company issued a press release announcing entry into the Collaboration Agreement.
A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and incorporated herein by reference. The exhibit furnished under Item 7.01 of this Current Report on Form 8-K 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, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act, regardless of any general incorporation language in such filing.
| Item 9.01 | Exhibits |
(d) Exhibits.
| 99.1 | Press release, dated July 30, 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 thereunto duly authorized.
| Viridian Therapeutics, Inc. | ||||||
| Date: July 30, 2024 | By: | /s/ Stephen Mahoney |
||||
| Stephen Mahoney | ||||||
| President and Chief Executive Officer | ||||||
Exhibit 99.1
Viridian Therapeutics Announces Collaboration and License Agreement with Kissei
Pharmaceutical to Develop and Commercialize Veligrotug and VRDN-003 in Japan with
an Upfront Payment of $70 Million and up to $315 Million in Milestone Payments
- Kissei obtains an exclusive license to develop and commercialize veligrotug and VRDN-003 in Japan -
- Viridian to receive an upfront payment of $70 million -
- Additionally, Viridian is eligible to receive up to an additional $315 million in development, regulatory,
and commercial milestone payments as well as tiered royalties on net sales in Japan in the 20s to
mid-30s percent -
- Collaboration combines Viridian’s potential best-in-class portfolio in thyroid eye disease with Kissei’s
development and commercialization expertise in rare diseases in Japan -
Waltham, Mass., July 30, 2025 — Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biopharmaceutical company focused on discovering, developing, and commercializing potential best-in-class medicines for serious and rare diseases, today announced that it has entered into an exclusive collaboration and license agreement with Kissei Pharmaceutical Co., Ltd. (“Kissei”) to develop and commercialize veligrotug and VRDN-003 in Japan. Both molecules are anti-insulin-like growth factor-1 receptor (IGF-1R) antibodies for the potential treatment of patients with thyroid eye disease (TED), and VRDN-003 is a potential best-in-class, subcutaneous, half-life extended anti-IGF-1R antibody with the same binding domain as veligrotug. TED is an autoimmune condition characterized by inflammation, growth, and damage to tissues around and behind the eye, often causing swelling, discomfort, and double vision, among other signs and symptoms.
“After running a very competitive partnering process, we are thrilled to partner with Kissei to bring these potential best-in-class medicines to TED patients in Japan,” said Steve Mahoney, Viridian’s President and CEO. “Kissei has an established strong track record of successfully developing and commercializing in-licensed, rare disease medicines. Kissei shares our enthusiasm and commitment to these programs, and we believe Kissei is an ideal partner for us in Japan. Both companies look forward to moving quickly to advance these novel treatment options for patients.”
“As we seek to further expand our pipeline in rare and intractable diseases, we are very excited by the potential of veligrotug and VRDN-003 to address the significant unmet needs of TED patients in Japan, based on veligrotug’s strong and consistent phase 3 clinical data in THRIVE and THRIVE-2,” said Mutsuo Kanzawa, Chairman and CEO of Kissei. “This collaboration reinforces our mission to contribute to the health of people around the world through innovative pharmaceutical products, and we are committed to bringing important treatment options to Japanese patients as rapidly as possible.”
Under the terms of the agreement, Viridian will grant Kissei an exclusive license to develop and commercialize veligrotug and VRDN-003 in Japan. Viridian will receive an upfront cash payment of $70 million, with the potential to receive an additional $315 million in development, regulatory, and commercial milestone payments, as well as tiered royalties on net sales in Japan with percentages ranging from the 20s to mid-30s. Kissei will be responsible for all development, regulatory, and commercialization activities, and associated costs, in Japan.
Renexes LLC served as an advisor to Viridian in connection with the transaction.
About Viridian Therapeutics
Viridian is a biopharmaceutical company focused on discovering, developing and commercializing potential best-in-class medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas.
Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The company is conducting a pivotal program for veligrotug (VRDN-001), including two global phase 3 clinical trials (THRIVE and THRIVE-2), to evaluate its efficacy and safety in patients with active and chronic TED. Both THRIVE and THRIVE-2 reported positive topline data, meeting all the primary and secondary endpoints of each study. Viridian is also advancing VRDN-003 as a potential best-in-class subcutaneous therapy for the treatment of TED, including two ongoing global phase 3 pivotal clinical trials, REVEAL-1 and REVEAL-2, to evaluate the efficacy and safety of VRDN-003 in patients with active and chronic TED.
In addition to its TED portfolio, Viridian is advancing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, including VRDN-006 and VRDN-008, which has the potential to be developed in multiple autoimmune diseases.
Viridian is based in Waltham, Massachusetts. For more information, please visit www.viridiantherapeutics.com. Follow Viridian on LinkedIn and X.
About Kissei Pharmaceutical Co., Ltd.
Kissei is a Japanese pharmaceutical company based on the management philosophy “contributing to society through high-quality, innovative pharmaceutical products” and “serving society through our employees.” As a strong R&D-oriented corporation, it concentrates on providing innovative pharmaceuticals to patients worldwide. Kissei is engaged in bringing new drugs into the world through drug discovery and licensing activities in its focus fields of rare/intractable diseases, urology, and nephrology/dialysis.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, “anticipate,” “believe,” “become,” “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “may,” “might,” “on track,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions.
Forward-looking statements include, without limitation, statements regarding: Viridian’s partnership with Kissei; Viridian’s ability to achieve development, regulatory, and commercial milestone payments and receive royalties on the commercial sale of our product candidates pursuant to the agreement with Kissei; clinical development and anticipated commercialization of Viridian’s product candidates, including veligrotug (formerly VRDN-001) and VRDN-003; the potential utility, efficacy, potency, safety, clinical benefits, clinical response, convenience, and number of indications of veligrotug and VRDN-003; Viridian’s product candidates potentially being best-in-class; whether veligrotug and VRDN-003 will serve an unmet need; and Viridian’s expectations regarding the potential commercialization of veligrotug and VRDN-003, if approved, including under the agreement with Kissei.
New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: potential utility, efficacy, potency, safety, clinical benefits, clinical response, and convenience of Viridian’s product candidates; that results or data from completed or ongoing clinical trials may not be representative of the results of ongoing or future clinical trials; that preliminary data may not be representative of final data; expectations and changes regarding the timing for regulatory filings; regulatory interactions; uncertainty and potential delays related to clinical drug development; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates; competition from other therapies or products; estimates of market size; our future operating results and financial performance; Viridian’s intellectual property position; that our product candidates may not be commercially successful, if approved; and other risks described from time to time in the “Risk Factors” section of our filings with the Securities and Exchange Commission (SEC), including those described in our most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as applicable, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date hereof.
Contact:
IR@viridiantherapeutics.com
Media@viridiantherapeutics.com
Source: Viridian Therapeutics, Inc.