[8-K] Viridian Therapeutics, Inc. Reports Material Event
Viridian Therapeutics (VRDN) filed an 8-K to disclose a collaboration and license agreement signed 30 Jul 2025 with Japan-based Kissei Pharmaceutical covering two IGF-1R monoclonal antibodies, veligrotug and VRDN-003, for thyroid eye disease and other potential indications in Japan. Kissei receives exclusive Japanese development and commercialization rights and a limited non-exclusive manufacturing right; Viridian retains global rights elsewhere and will supply product.
Financial terms: Kissei will pay $70 million upfront. Viridian is eligible for up to $315 million in development, regulatory and sales milestones. Tiered royalties in the low-20% to mid-30% range on future Japanese sales will follow launch. Kissei funds Japanese clinical, regulatory and commercial activities under joint-steering oversight, reducing Viridian’s cash burden.
Strategic impact: The agreement delivers immediate, non-dilutive capital, extends cash runway and externally validates VRDN-003/veligrotug while preserving all ex-Japan upside. Key execution risks include dependence on Kissei’s development success and Viridian’s ongoing manufacturing obligations.
Viridian Therapeutics (VRDN) ha presentato un modulo 8-K per comunicare un accordo di collaborazione e licenza firmato il 30 luglio 2025 con la giapponese Kissei Pharmaceutical, riguardante due anticorpi monoclonali IGF-1R, veligrotug e VRDN-003, per la malattia oculare tiroidea e altre potenziali indicazioni in Giappone. Kissei ottiene i diritti esclusivi di sviluppo e commercializzazione in Giappone e un diritto di produzione limitato non esclusivo; Viridian mantiene i diritti globali per gli altri territori e fornirà il prodotto.
Termini finanziari: Kissei pagherà un anticipo di 70 milioni di dollari. Viridian potrà ricevere fino a 315 milioni di dollari in milestone di sviluppo, regolatorie e di vendita. Dopo il lancio, saranno applicate royalty a scaglioni nella fascia dal basso 20% al medio 30% sulle vendite future in Giappone. Kissei finanzierà le attività cliniche, regolatorie e commerciali in Giappone sotto una supervisione congiunta, riducendo l'onere finanziario per Viridian.
Impatto strategico: L'accordo fornisce capitale immediato e non diluitivo, estende la liquidità disponibile e convalida esternamente VRDN-003/veligrotug, preservando tutti i potenziali guadagni al di fuori del Giappone. I principali rischi di esecuzione includono la dipendenza dal successo dello sviluppo da parte di Kissei e gli obblighi continui di produzione di Viridian.
Viridian Therapeutics (VRDN) presentó un formulario 8-K para revelar un acuerdo de colaboración y licencia firmado el 30 de julio de 2025 con la japonesa Kissei Pharmaceutical, que abarca dos anticuerpos monoclonales IGF-1R, veligrotug y VRDN-003, para la enfermedad ocular tiroidea y otras indicaciones potenciales en Japón. Kissei recibe los derechos exclusivos de desarrollo y comercialización en Japón y un derecho limitado de fabricación no exclusivo; Viridian mantiene los derechos globales fuera de Japón y suministrará el producto.
Términos financieros: Kissei pagará un anticipo de 70 millones de dólares. Viridian es elegible para recibir hasta 315 millones de dólares en hitos de desarrollo, regulatorios y de ventas. Después del lanzamiento, se aplicarán regalías escalonadas en un rango de bajo 20% a medio 30% sobre las ventas futuras en Japón. Kissei financiará las actividades clínicas, regulatorias y comerciales en Japón bajo una supervisión conjunta, reduciendo la carga financiera de Viridian.
Impacto estratégico: El acuerdo proporciona capital inmediato y no dilutivo, extiende la liquidez y valida externamente VRDN-003/veligrotug, preservando todo el potencial fuera de Japón. Los principales riesgos de ejecución incluyen la dependencia del éxito del desarrollo por parte de Kissei y las obligaciones continuas de fabricación de Viridian.
Viridian Therapeutics(VRDN)는 2025년 7월 30일 일본 기반의 Kissei Pharmaceutical과 갑상선 안병증 및 기타 잠재적 적응증을 위한 두 가지 IGF-1R 단클론항체인 veligrotug와 VRDN-003에 관한 협력 및 라이선스 계약을 체결했다고 8-K 보고서를 통해 공시했습니다. Kissei는 일본 내 독점적 개발 및 상업화 권리와 제한적 비독점적 제조 권리를 부여받으며, Viridian은 일본 외 전 세계 권리를 유지하고 제품을 공급합니다.
재무 조건: Kissei는 7,000만 달러의 선불금을 지급합니다. Viridian은 개발, 규제 및 판매 마일스톤으로 최대 3억 1,500만 달러를 받을 자격이 있습니다. 출시 후 일본 내 미래 매출에 대해 20% 초반에서 30% 중반대의 단계별 로열티가 적용됩니다. Kissei는 공동 운영 감독 하에 일본 내 임상, 규제 및 상업 활동을 자금 지원하여 Viridian의 현금 부담을 줄입니다.
전략적 영향: 이 계약은 즉각적이고 희석되지 않는 자본을 제공하며, 현금 운용 기간을 연장하고 VRDN-003/veligrotug를 외부에서 검증하는 동시에 일본 외 모든 잠재적 이익을 보존합니다. 주요 실행 위험은 Kissei의 개발 성공 의존성과 Viridian의 지속적인 제조 의무입니다.
Viridian Therapeutics (VRDN) a déposé un formulaire 8-K pour divulguer un accord de collaboration et de licence signé le 30 juillet 2025 avec la société japonaise Kissei Pharmaceutical, portant sur deux anticorps monoclonaux IGF-1R, veligrotug et VRDN-003, destinés à la maladie oculaire thyroïdienne et à d'autres indications potentielles au Japon. Kissei obtient les droits exclusifs de développement et de commercialisation au Japon ainsi qu'un droit de fabrication limité non exclusif ; Viridian conserve les droits mondiaux hors Japon et fournira le produit.
Conditions financières : Kissei versera un paiement initial de 70 millions de dollars. Viridian peut recevoir jusqu'à 315 millions de dollars en jalons de développement, réglementaires et commerciaux. Des redevances échelonnées allant de la plage basse des 20 % à la moyenne des 30 % seront appliquées sur les ventes futures au Japon après le lancement. Kissei financera les activités cliniques, réglementaires et commerciales au Japon sous supervision conjointe, réduisant ainsi la charge financière de Viridian.
Impact stratégique : Cet accord apporte un capital immédiat non dilutif, prolonge la trésorerie disponible et valide extérieurement VRDN-003/veligrotug tout en préservant tous les avantages hors Japon. Les principaux risques d'exécution incluent la dépendance au succès du développement par Kissei et les obligations continues de fabrication de Viridian.
Viridian Therapeutics (VRDN) hat eine 8-K-Meldung eingereicht, um eine am 30. Juli 2025 unterzeichnete Kooperations- und Lizenzvereinbarung mit dem japanischen Unternehmen Kissei Pharmaceutical offenzulegen. Diese betrifft zwei IGF-1R monoklonale Antikörper, veligrotug und VRDN-003, für die Schilddrüsenaugenkrankheit und weitere potenzielle Indikationen in Japan. Kissei erhält exklusive japanische Entwicklungs- und Vermarktungsrechte sowie ein begrenztes nicht-exklusives Herstellungsrecht; Viridian behält die globalen Rechte außerhalb Japans und wird das Produkt liefern.
Finanzielle Bedingungen: Kissei zahlt eine Vorauszahlung von 70 Millionen US-Dollar. Viridian kann bis zu 315 Millionen US-Dollar an Entwicklungs-, Zulassungs- und Verkaufsmeilensteinen erhalten. Nach Markteinführung folgen gestaffelte Lizenzgebühren im niedrigen 20%- bis mittleren 30%-Bereich auf zukünftige japanische Verkäufe. Kissei finanziert die klinischen, regulatorischen und kommerziellen Aktivitäten in Japan unter gemeinsamer Steuerung, was die finanzielle Belastung für Viridian reduziert.
Strategische Auswirkungen: Die Vereinbarung bringt sofortiges, nicht verwässerndes Kapital, verlängert die finanzielle Reichweite und validiert VRDN-003/veligrotug extern, während alle Chancen außerhalb Japans erhalten bleiben. Wesentliche Ausführungsrisiken sind die Abhängigkeit vom Entwicklungserfolg Kisseis und Viridians fortlaufende Herstellungsverpflichtungen.
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Insights
TL;DR: $70 m upfront and rich royalties provide non-dilutive cash and regional validation; execution remains Japan-dependent.
The deal injects $70 m cash immediately—roughly equal to ~20-25% of Viridian’s 2024 year-end cash burn—without equity dilution. Potential $315 m milestones plus up-to mid-30% royalties create meaningful long-term optionality if veligrotug/VRDN-003 succeed in Japan. Viridian off-loads costly local trials and commercial build-out, improving capital efficiency. Retaining global rights keeps future M&A optional. Risks: all economics outside the upfront are contingent on Japanese regulatory approval and market adoption; Viridian must still manufacture product, exposing it to supply-chain and COGS risk. Overall, the agreement is strategically and financially accretive.
TL;DR: Classic territory out-license secures cash runway and confirms asset value; limited to Japan and milestone-heavy.
This structure mirrors recent ophthalmology out-licenses, with an attractive royalty slope (>20%) that suggests confidence in premium pricing. Kissei gains a differentiated biologic for an underserved indication, while Viridian accelerates geographic expansion via a local player experienced with niche hospital markets. Milestone stack is back-loaded to commercialization, aligning incentives. Manufacturing retention keeps Viridian close to product quality but may strain capacity. Negotiated rights are fairly standard; termination clauses unspecified but typically allow reversion—protecting Viridian. Deal should be well-received by investors looking for continued non-dilutive financing.
Viridian Therapeutics (VRDN) ha presentato un modulo 8-K per comunicare un accordo di collaborazione e licenza firmato il 30 luglio 2025 con la giapponese Kissei Pharmaceutical, riguardante due anticorpi monoclonali IGF-1R, veligrotug e VRDN-003, per la malattia oculare tiroidea e altre potenziali indicazioni in Giappone. Kissei ottiene i diritti esclusivi di sviluppo e commercializzazione in Giappone e un diritto di produzione limitato non esclusivo; Viridian mantiene i diritti globali per gli altri territori e fornirà il prodotto.
Termini finanziari: Kissei pagherà un anticipo di 70 milioni di dollari. Viridian potrà ricevere fino a 315 milioni di dollari in milestone di sviluppo, regolatorie e di vendita. Dopo il lancio, saranno applicate royalty a scaglioni nella fascia dal basso 20% al medio 30% sulle vendite future in Giappone. Kissei finanzierà le attività cliniche, regolatorie e commerciali in Giappone sotto una supervisione congiunta, riducendo l'onere finanziario per Viridian.
Impatto strategico: L'accordo fornisce capitale immediato e non diluitivo, estende la liquidità disponibile e convalida esternamente VRDN-003/veligrotug, preservando tutti i potenziali guadagni al di fuori del Giappone. I principali rischi di esecuzione includono la dipendenza dal successo dello sviluppo da parte di Kissei e gli obblighi continui di produzione di Viridian.
Viridian Therapeutics (VRDN) presentó un formulario 8-K para revelar un acuerdo de colaboración y licencia firmado el 30 de julio de 2025 con la japonesa Kissei Pharmaceutical, que abarca dos anticuerpos monoclonales IGF-1R, veligrotug y VRDN-003, para la enfermedad ocular tiroidea y otras indicaciones potenciales en Japón. Kissei recibe los derechos exclusivos de desarrollo y comercialización en Japón y un derecho limitado de fabricación no exclusivo; Viridian mantiene los derechos globales fuera de Japón y suministrará el producto.
Términos financieros: Kissei pagará un anticipo de 70 millones de dólares. Viridian es elegible para recibir hasta 315 millones de dólares en hitos de desarrollo, regulatorios y de ventas. Después del lanzamiento, se aplicarán regalías escalonadas en un rango de bajo 20% a medio 30% sobre las ventas futuras en Japón. Kissei financiará las actividades clínicas, regulatorias y comerciales en Japón bajo una supervisión conjunta, reduciendo la carga financiera de Viridian.
Impacto estratégico: El acuerdo proporciona capital inmediato y no dilutivo, extiende la liquidez y valida externamente VRDN-003/veligrotug, preservando todo el potencial fuera de Japón. Los principales riesgos de ejecución incluyen la dependencia del éxito del desarrollo por parte de Kissei y las obligaciones continuas de fabricación de Viridian.
Viridian Therapeutics(VRDN)는 2025년 7월 30일 일본 기반의 Kissei Pharmaceutical과 갑상선 안병증 및 기타 잠재적 적응증을 위한 두 가지 IGF-1R 단클론항체인 veligrotug와 VRDN-003에 관한 협력 및 라이선스 계약을 체결했다고 8-K 보고서를 통해 공시했습니다. Kissei는 일본 내 독점적 개발 및 상업화 권리와 제한적 비독점적 제조 권리를 부여받으며, Viridian은 일본 외 전 세계 권리를 유지하고 제품을 공급합니다.
재무 조건: Kissei는 7,000만 달러의 선불금을 지급합니다. Viridian은 개발, 규제 및 판매 마일스톤으로 최대 3억 1,500만 달러를 받을 자격이 있습니다. 출시 후 일본 내 미래 매출에 대해 20% 초반에서 30% 중반대의 단계별 로열티가 적용됩니다. Kissei는 공동 운영 감독 하에 일본 내 임상, 규제 및 상업 활동을 자금 지원하여 Viridian의 현금 부담을 줄입니다.
전략적 영향: 이 계약은 즉각적이고 희석되지 않는 자본을 제공하며, 현금 운용 기간을 연장하고 VRDN-003/veligrotug를 외부에서 검증하는 동시에 일본 외 모든 잠재적 이익을 보존합니다. 주요 실행 위험은 Kissei의 개발 성공 의존성과 Viridian의 지속적인 제조 의무입니다.
Viridian Therapeutics (VRDN) a déposé un formulaire 8-K pour divulguer un accord de collaboration et de licence signé le 30 juillet 2025 avec la société japonaise Kissei Pharmaceutical, portant sur deux anticorps monoclonaux IGF-1R, veligrotug et VRDN-003, destinés à la maladie oculaire thyroïdienne et à d'autres indications potentielles au Japon. Kissei obtient les droits exclusifs de développement et de commercialisation au Japon ainsi qu'un droit de fabrication limité non exclusif ; Viridian conserve les droits mondiaux hors Japon et fournira le produit.
Conditions financières : Kissei versera un paiement initial de 70 millions de dollars. Viridian peut recevoir jusqu'à 315 millions de dollars en jalons de développement, réglementaires et commerciaux. Des redevances échelonnées allant de la plage basse des 20 % à la moyenne des 30 % seront appliquées sur les ventes futures au Japon après le lancement. Kissei financera les activités cliniques, réglementaires et commerciales au Japon sous supervision conjointe, réduisant ainsi la charge financière de Viridian.
Impact stratégique : Cet accord apporte un capital immédiat non dilutif, prolonge la trésorerie disponible et valide extérieurement VRDN-003/veligrotug tout en préservant tous les avantages hors Japon. Les principaux risques d'exécution incluent la dépendance au succès du développement par Kissei et les obligations continues de fabrication de Viridian.
Viridian Therapeutics (VRDN) hat eine 8-K-Meldung eingereicht, um eine am 30. Juli 2025 unterzeichnete Kooperations- und Lizenzvereinbarung mit dem japanischen Unternehmen Kissei Pharmaceutical offenzulegen. Diese betrifft zwei IGF-1R monoklonale Antikörper, veligrotug und VRDN-003, für die Schilddrüsenaugenkrankheit und weitere potenzielle Indikationen in Japan. Kissei erhält exklusive japanische Entwicklungs- und Vermarktungsrechte sowie ein begrenztes nicht-exklusives Herstellungsrecht; Viridian behält die globalen Rechte außerhalb Japans und wird das Produkt liefern.
Finanzielle Bedingungen: Kissei zahlt eine Vorauszahlung von 70 Millionen US-Dollar. Viridian kann bis zu 315 Millionen US-Dollar an Entwicklungs-, Zulassungs- und Verkaufsmeilensteinen erhalten. Nach Markteinführung folgen gestaffelte Lizenzgebühren im niedrigen 20%- bis mittleren 30%-Bereich auf zukünftige japanische Verkäufe. Kissei finanziert die klinischen, regulatorischen und kommerziellen Aktivitäten in Japan unter gemeinsamer Steuerung, was die finanzielle Belastung für Viridian reduziert.
Strategische Auswirkungen: Die Vereinbarung bringt sofortiges, nicht verwässerndes Kapital, verlängert die finanzielle Reichweite und validiert VRDN-003/veligrotug extern, während alle Chancen außerhalb Japans erhalten bleiben. Wesentliche Ausführungsrisiken sind die Abhängigkeit vom Entwicklungserfolg Kisseis und Viridians fortlaufende Herstellungsverpflichtungen.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| 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 | ||||||
FAQ
What did Viridian Therapeutics (VRDN) announce in its 8-K?
How much upfront cash will VRDN receive from Kissei?
What is the total potential milestone value of the Kissei deal?
What royalty rate will Viridian earn on Japanese sales?
Who is responsible for development and commercialization in Japan?
Does Viridian retain rights outside Japan?
