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Adagene announces up to $25 million strategic investment from Sanofi

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Adagene (NASDAQ:ADAG), a developer of antibody-based therapies, has secured a strategic investment of up to $25 million from Sanofi (Euronext: SAN FP). The investment strengthens their existing partnership and includes Sanofi's exercise of an option for a third SAFEbody discovery program.

The funding will support Adagene's R&D activities, particularly the clinical development of muzastotug (ADG126), an anti-CTLA-4 SAFEbody, through a randomized phase 2 trial in microsatellite stable colorectal cancer. Additionally, Sanofi will sponsor a phase 1/2 clinical trial evaluating muzastotug in combination with other anticancer therapies in over 100 advanced solid tumor patients.

As of December 31, 2024, Adagene reported cash and cash equivalents of $85.2 million. With Sanofi's investment, the company expects to extend its cash runway into 2027. The partnership will be further strengthened by the addition of a Sanofi representative to Adagene's Scientific Advisory Board.

Adagene (NASDAQ:ADAG), sviluppatore di terapie basate su anticorpi, ha ottenuto un investimento strategico fino a 25 milioni di dollari da Sanofi (Euronext: SAN FP). Questo investimento rafforza la collaborazione esistente e include l'esercizio da parte di Sanofi di un'opzione per un terzo programma di scoperta SAFEbody.

I fondi sosterranno le attività di ricerca e sviluppo di Adagene, in particolare lo sviluppo clinico di muzastotug (ADG126), un SAFEbody anti-CTLA-4, attraverso uno studio di fase 2 randomizzato sul cancro colorettale microsatellite stabile. Inoltre, Sanofi sponsorizzerà uno studio clinico di fase 1/2 per valutare muzastotug in combinazione con altre terapie antitumorali in oltre 100 pazienti con tumori solidi avanzati.

Al 31 dicembre 2024, Adagene ha riportato liquidità e equivalenti di cassa pari a 85,2 milioni di dollari. Grazie all'investimento di Sanofi, l'azienda prevede di estendere la propria disponibilità finanziaria fino al 2027. La partnership sarà ulteriormente rafforzata con l'inserimento di un rappresentante Sanofi nel Consiglio Scientifico di Adagene.

Adagene (NASDAQ:ADAG), desarrollador de terapias basadas en anticuerpos, ha asegurado una inversión estratégica de hasta 25 millones de dólares por parte de Sanofi (Euronext: SAN FP). Esta inversión fortalece su asociación existente e incluye el ejercicio por parte de Sanofi de una opción para un tercer programa de descubrimiento SAFEbody.

Los fondos apoyarán las actividades de I+D de Adagene, especialmente el desarrollo clínico de muzastotug (ADG126), un SAFEbody anti-CTLA-4, mediante un ensayo aleatorizado de fase 2 en cáncer colorrectal estable microsatélites. Además, Sanofi patrocinará un ensayo clínico de fase 1/2 para evaluar muzastotug en combinación con otras terapias anticancerígenas en más de 100 pacientes con tumores sólidos avanzados.

Al 31 de diciembre de 2024, Adagene reportó efectivo y equivalentes de efectivo por 85,2 millones de dólares. Con la inversión de Sanofi, la compañía espera extender su liquidez hasta 2027. La asociación se fortalecerá aún más con la incorporación de un representante de Sanofi en el Consejo Asesor Científico de Adagene.

Adagene (NASDAQ:ADAG)는 항체 기반 치료제를 개발하는 회사로, Sanofi (Euronext: SAN FP)로부터 최대 2,500만 달러의 전략적 투자를 확보했습니다. 이번 투자는 기존 파트너십을 강화하며, Sanofi가 세 번째 SAFEbody 발견 프로그램 옵션을 행사하는 것을 포함합니다.

이번 자금은 Adagene의 연구개발 활동, 특히 마이크로새틀라이트 안정성 대장암에 대한 무작위 배정 2상 임상시험을 통해 muzastotug (ADG126)이라는 항-CTLA-4 SAFEbody의 임상 개발을 지원할 예정입니다. 또한 Sanofi는 100명 이상의 진행성 고형암 환자를 대상으로 muzastotug와 기타 항암 치료제 병용을 평가하는 1/2상 임상시험을 후원할 것입니다.

2024년 12월 31일 기준으로 Adagene는 8520만 달러의 현금 및 현금성 자산을 보유하고 있습니다. Sanofi의 투자로 회사는 자금 운용 기간을 2027년까지 연장할 것으로 기대합니다. 또한 Sanofi 대표가 Adagene의 과학 자문위원회에 합류하면서 파트너십이 더욱 강화될 것입니다.

Adagene (NASDAQ:ADAG), développeur de thérapies à base d'anticorps, a obtenu un investissement stratégique allant jusqu'à 25 millions de dollars de Sanofi (Euronext : SAN FP). Cet investissement renforce leur partenariat existant et inclut l'exercice par Sanofi d'une option pour un troisième programme de découverte SAFEbody.

Le financement soutiendra les activités de R&D d'Adagene, en particulier le développement clinique de muzastotug (ADG126), un SAFEbody anti-CTLA-4, via un essai de phase 2 randomisé dans le cancer colorectal stable au niveau des microsatellites. De plus, Sanofi sponsorisera un essai clinique de phase 1/2 évaluant muzastotug en combinaison avec d'autres thérapies anticancéreuses chez plus de 100 patients atteints de tumeurs solides avancées.

Au 31 décembre 2024, Adagene a déclaré 85,2 millions de dollars en liquidités et équivalents de trésorerie. Grâce à l'investissement de Sanofi, la société prévoit d'étendre sa trésorerie jusqu'en 2027. Le partenariat sera également renforcé par l'ajout d'un représentant de Sanofi au conseil consultatif scientifique d'Adagene.

Adagene (NASDAQ:ADAG), ein Entwickler von antikörperbasierten Therapien, hat eine strategische Investition von bis zu 25 Millionen US-Dollar von Sanofi (Euronext: SAN FP) erhalten. Die Investition stärkt die bestehende Partnerschaft und beinhaltet die Ausübung einer Option von Sanofi für ein drittes SAFEbody-Entdeckungsprogramm.

Die Finanzierung wird Adagenes F&E-Aktivitäten unterstützen, insbesondere die klinische Entwicklung von muzastotug (ADG126), einem anti-CTLA-4 SAFEbody, durch eine randomisierte Phase-2-Studie bei mikrosatellitenstabilem kolorektalem Krebs. Zusätzlich wird Sanofi eine Phase-1/2-Studie sponsern, die muzastotug in Kombination mit anderen Krebsmedikamenten bei über 100 Patienten mit fortgeschrittenen soliden Tumoren evaluiert.

Zum 31. Dezember 2024 meldete Adagene Barmittel und Zahlungsmitteläquivalente in Höhe von 85,2 Millionen US-Dollar. Mit der Investition von Sanofi erwartet das Unternehmen, seinen finanziellen Spielraum bis 2027 zu verlängern. Die Partnerschaft wird zudem durch die Aufnahme eines Sanofi-Vertreters in den Wissenschaftlichen Beirat von Adagene weiter gestärkt.

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Insights

Sanofi's $25M investment and program expansion validates Adagene's SAFEbody platform, extending cash runway into 2027.

This strategic investment from Sanofi represents a significant validation of Adagene's SAFEbody platform technology, particularly for its lead candidate muzastotug (ADG126). The deal structure is multifaceted, comprising $25 million in equity investment plus an option exercise for a third discovery program that triggers additional payments.

The partnership expansion is particularly noteworthy as it includes Sanofi sponsoring a combination clinical trial with muzastotug in over 100 patients while Adagene retains worldwide commercial rights. This arrangement allows Adagene to leverage Sanofi's resources for clinical development while maintaining full ownership of its lead asset - an ideal scenario for a smaller biotech.

From a financial perspective, this deal substantially strengthens Adagene's position. With $85.2 million in cash as of December 2024, the additional funding extends their runway into 2027, providing approximately 2.5 years of operational security. This runway gives them sufficient time to generate meaningful clinical data for muzastotug, particularly in microsatellite stable colorectal cancer (MSS CRC) - a difficult-to-treat indication where current anti-CTLA-4 therapies have faced dose-limiting challenges.

The addition of a Sanofi representative to Adagene's Scientific Advisory Board further cements this relationship and suggests potential for additional collaboration beyond the current agreement. This strategic alignment with a major pharmaceutical company reduces Adagene's execution risk while providing scientific validation of their masked antibody approach to improving the therapeutic window of immune checkpoint inhibitors.

- Sanofi to exercise option on third SAFEbody discovery program and sponsor combination clinical trial with muzastotug

- Company expects proceeds to extend cash runway into 2027

SAN DIEGO and SUZHOU, China, July 01, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene or the Company”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced strategic investment and option exercise by Sanofi (Euronext: SAN FP).

Sanofi has agreed to make strategic investment of up to US$25 million in Adagene. The Company plans to use the proceeds to fund its research and development activities, including clinical development of muzastotug (ADG126), an anti-CTLA-4 SAFEbody, through a randomized phase 2 trial in microsatellite stable colorectal cancer (MSS CRC).

To further explore the clinical potential of muzastotug, Adagene will supply Sanofi with muzastotug to evaluate the safety, efficacy, pharmacokinetics and biomarker data in combination with other anticancer therapies in over 100 patients in a phase 1/2 clinical trial in advanced solid tumors. Adagene continues to own worldwide commercial rights to muzastotug.

Sanofi has also exercised its option to select a third SAFEbody discovery program, utilizing Adagene’s proprietary masking technology and antibody engineering expertise. The bispecific therapeutic, with undisclosed targets, will be engineered by Adagene and induces an option exercise fee, as well as milestones and royalties as per the 2022 partnership agreement with Adagene.

“Expanding our partnership with Sanofi highlights the potential of our SAFEbody platform and the clinical proof of concept for ADG126, our masked anti-CTLA-4 program and the most advanced of its kind,” said Peter Luo, Chairman, CEO and President of R&D at Adagene. “This strategic partnership reinforces our shared vision of ADG126’s promise in advanced solid tumors, including MSS CRC, where dose-limiting challenges have hindered anti-CTLA-4 therapies. We value our trusted relationship with Sanofi.”

As of December 31, 2024, the Company had audited cash and cash equivalents of US$85.2 million. The proceeds from the investment of Sanofi, together with the current cash and cash equivalents, are expected to be sufficient to fund planned operations into 2027.

Following the equity investment and strategic collaborations, a Sanofi representative will join Adagene’s Scientific Advisory Board (SAB), which provides strategic advice on the scientific and clinical aspects of the Company’s activities.

About Adagene

Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biotechnology company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address globally unmet patient needs. The company has forged strategic collaborations with reputable global partners that leverage its SAFEbody® precision masking technology in multiple approaches at the vanguard of science.

Powered by its proprietary Dynamic Precision Library (DPL) platform, composed of NEObody™, SAFEbody, and POWERbody™ technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. The company’s SAFEbody technology is designed to address safety and tolerability challenges associated with many antibody therapeutics by using precision masking technology to shield the binding domain of the biologic therapy. Through activation in the tumor microenvironment, this allows for tumor-specific targeting of antibodies in tumor microenvironment, while minimizing on-target off-tumor toxicity in healthy tissues.

Adagene’s lead clinical program, ADG126 (muzastotug), is a masked, anti-CTLA-4 SAFEbody that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor microenvironment. ADG126 is currently in phase 1b/2 clinical studies in combination with anti-PD-1 therapy, particularly focused on Metastatic Microsatellite-stable (MSS) Colorectal Cancer (CRC). Validated by ongoing clinical research, the SAFEbody platform can be applied to a wide variety of antibody-based therapeutic modalities, including Fc empowered antibodies, antibody-drug conjugates, and bi/multi-specific T-cell engagers.

For more information, please visit: https://investor.adagene.com.

Follow Adagene on WeChatLinkedIn and X.

SAFEbody® is a registered trademark in the United States, China, Australia, Japan, Singapore, and the European Union.

Safe Harbor Statement

This press release contains forward-looking statements, including statements regarding the impact of Sanofi’s strategic investment and Adagene’s relationship with Sanofi; the expected timeframe for funding Adagene’s operating plan with current cash and cash equivalents and the proceeds from Sanofi’s investment; certain clinical results of ADG126, the potential implications of clinical data for patients, and Adagene’s advancement of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Adagene’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Adagene’s drug candidates; Adagene’s ability to achieve commercial success for its drug candidates, if approved; Adagene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene’s reliance on third parties to conduct drug development, manufacturing and other services; Adagene’s limited operating history and Adagene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene’s ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, as well as those risks more fully discussed in the “Risk Factors” section in Adagene’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Investor Contacts:

Raymond Tam
raymond_tam@adagene.com

Corey Davis
LifeSci Advisors
cdavis@lifesciadvisors.com

Media Contact:

Lindsay Rocco
Elixir Health Public Relations
lrocco@elixirhealthpr.com
+1 862-596-1304


FAQ

What is the value of Sanofi's strategic investment in Adagene (NASDAQ:ADAG)?

Sanofi has agreed to make a strategic investment of up to $25 million in Adagene.

How will Adagene use the proceeds from Sanofi's investment?

The proceeds will fund R&D activities, including clinical development of muzastotug (ADG126) through a randomized phase 2 trial in microsatellite stable colorectal cancer (MSS CRC).

What is the current cash position of Adagene (ADAG)?

As of December 31, 2024, Adagene had cash and cash equivalents of $85.2 million, with the cash runway expected to extend into 2027 following Sanofi's investment.

What are the key components of the Adagene-Sanofi partnership expansion?

The partnership includes Sanofi's $25 million investment, exercise of a third SAFEbody discovery program option, sponsorship of a combination clinical trial, and addition of a Sanofi representative to Adagene's Scientific Advisory Board.

How many patients will be included in the Sanofi-sponsored muzastotug clinical trial?

The phase 1/2 clinical trial will evaluate muzastotug in combination with other anticancer therapies in over 100 patients with advanced solid tumors.
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