Ligand Leads $75 Million Royalty Financing in Castle Creek Biosciences
Ligand Pharmaceuticals (Nasdaq: LGND) has announced a $75 million royalty financing agreement with Castle Creek Biosciences to support the Phase 3 clinical study of D-Fi (FCX-007), an autologous gene-modified cell therapy for dystrophic epidermolysis bullosa (DEB). Ligand invested $50 million, leading a syndicate of co-investors who contributed $25 million, in exchange for a high-single digit royalty on worldwide sales of D-Fi. The syndicate includes Paragon Biosciences, Valor Equity Partners, and XOMA Royalty (Nasdaq: XOMA).
D-Fi, an injectable therapy, addresses DEB, a rare genetic skin disorder caused by a mutation in the COL7A1 gene. The therapy uses genetically modified dermal fibroblasts to express COL7 protein, aiding the formation of skin anchoring fibrils. Clinical studies have shown D-Fi to be generally well tolerated, with injection site reactions being the primary adverse effects.
D-Fi has received multiple FDA designations, including Orphan Drug, Rare Pediatric Disease, Fast Track, and Regenerative Medicine Advanced Therapy for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).
Ligand Pharmaceuticals (Nasdaq: LGND) ha annunciato un accordo di finanziamento tramite royalties di 75 milioni di dollari con Castle Creek Biosciences per supportare lo studio clinico di Fase 3 di D-Fi (FCX-007), una terapia cellulare autologa modificata geneticamente per l'epidermolisi bollosa distruttiva (DEB). Ligand ha investito 50 milioni di dollari, guidando un sindacato di co-investitori che hanno contribuito con 25 milioni di dollari, in cambio di una royalty a cifra alta su vendite mondiali di D-Fi. Il sindacato include Paragon Biosciences, Valor Equity Partners e XOMA Royalty (Nasdaq: XOMA).
D-Fi, una terapia iniettabile, affronta la DEB, un raro disturbo genetico della pelle causato da una mutazione nel gene COL7A1. La terapia utilizza fibroblasti dermici modificati geneticamente per esprimere la proteina COL7, aiutando la formazione dei fibrilli di ancoraggio della pelle. Gli studi clinici hanno dimostrato che D-Fi è generalmente ben tollerato, con reazioni nel sito di iniezione come principali effetti avversi.
D-Fi ha ricevuto molteplici designazioni dalla FDA, tra cui Farmaco Orfano, Malattia Pediatrica Rara, Percorso Veloce e Terapia Avanzata di Medicina Rigenerativa per il trattamento dell'epidermolisi bollosa distruttiva recessiva (RDEB).
Ligand Pharmaceuticals (Nasdaq: LGND) ha anunciado un acuerdo de financiación por regalías de 75 millones de dólares con Castle Creek Biosciences para apoyar el estudio clínico de Fase 3 de D-Fi (FCX-007), una terapia celular autóloga modificada genéticamente para la epidermólisis bullosa distrófica (DEB). Ligand invirtió 50 millones de dólares, liderando un sindicato de co-inversores que contribuyeron con 25 millones de dólares, a cambio de una regalía de un solo dígito alto sobre las ventas mundiales de D-Fi. El sindicato incluye a Paragon Biosciences, Valor Equity Partners y XOMA Royalty (Nasdaq: XOMA).
D-Fi, una terapia inyectable, aborda la DEB, un raro trastorno genético de la piel causado por una mutación en el gen COL7A1. La terapia utiliza fibroblastos dérmicos modificados genéticamente para expresar la proteína COL7, ayudando en la formación de fibrillas de anclaje de la piel. Los estudios clínicos han demostrado que D-Fi es generalmente bien tolerado, siendo las reacciones en el sitio de inyección los principales efectos adversos.
D-Fi ha recibido múltiples designaciones de la FDA, incluyendo Medicamento Huérfano, Enfermedad Pediátrica Rara, Vía Rápida y Terapia Avanzada de Medicina Regenerativa para el tratamiento de la epidermólisis bullosa distrófica recesiva (RDEB).
리간드 제약 (Nasdaq: LGND)은 7500만 달러 규모의 로열티 금융 계약을 캐슬 크릭 바이오사이언스와 체결하여 D-Fi (FCX-007)의 3상 임상 연구를 지원한다고 발표했습니다. D-Fi는 자가 유전자 수정 세포 치료제이며, 피부에 발생하는 드문 유전 질환인 피부박리증 (DEB)에 대한 치료법입니다. 리간드는 5000만 달러를 투자하며, 2500만 달러를 기여한 공동 투자자들의 신디케이트를 이끌었습니다. 이 신디케이트에는 파라곤 바이오사이언스, 밸러 이퀴티 파트너스, XOMA 로열티 (Nasdaq: XOMA)가 포함됩니다.
D-Fi는 주사 가능한 치료법으로, COL7A1 유전자의 돌연변이에 의해 발생하는 드문 유전 피부 질환인 DEB에 대응합니다. 이 치료법은 유전자 변형된 진피 섬유아세포를 사용하여 COL7 단백질을 발현시켜 피부 고정 섬유소의 형성을 돕습니다. 임상 연구에 따르면 D-Fi는 일반적으로 잘 견디며, 주사 부위 반응이 주요 부작용으로 나타났습니다.
D-Fi는 FDA로부터 고아약, 희귀 소아 질환, 신속 심사 및 재생 의학 고급 치료제 등 여러 가지 지정을 받았습니다. 이는 열성형 피부박리증 (RDEB) 치료를 위한 것입니다.
Ligand Pharmaceuticals (Nasdaq: LGND) a annoncé un accord de financement par redevances de 75 millions de dollars avec Castle Creek Biosciences pour soutenir l'étude clinique de Phase 3 de D-Fi (FCX-007), une thérapie cellulaire autologue modifiée génétiquement pour l'épidermolyse bulleuse dystrophique (DEB). Ligand a investi 50 millions de dollars, dirigeant un syndicat de co-investisseurs qui ont contribué 25 millions de dollars, en échange d'une redevance à un chiffre élevé sur les ventes mondiales de D-Fi. Le syndicat comprend Paragon Biosciences, Valor Equity Partners et XOMA Royalty (Nasdaq: XOMA).
D-Fi, une thérapie injectable, s'attaque à la DEB, un trouble cutané génétique rare causé par une mutation du gène COL7A1. La thérapie utilise des fibroblastes dermiques modifiés génétiquement pour exprimer la protéine COL7, aidant à la formation de fibrilles d'ancrage cutané. Des études cliniques ont montré que D-Fi est généralement bien toléré, les réactions au site d'injection étant les principaux effets indésirables.
D-Fi a reçu plusieurs désignations de la FDA, y compris Médicament Orphelin, Maladie Pédiatrique Rare, Voie Accélérée et Thérapie Avancée en Médecine Régénérative pour le traitement de l'épidermolyse bulleuse dystrophique récessive (RDEB).
Ligand Pharmaceuticals (Nasdaq: LGND) hat eine 75 Millionen Dollar umfassende Lizenzfinanzierungsvereinbarung mit Castle Creek Biosciences bekannt gegeben, um die Phase-3-Studie von D-Fi (FCX-007), einer autologen gentherapeutischen Zelltherapie für die dystrophische Epidermolysis bullosa (DEB), zu unterstützen. Ligand investierte 50 Millionen Dollar und führte ein Syndikat von Co-Investoren, die 25 Millionen Dollar beisteuerten, im Austausch für eine hohe einstellige Lizenzgebühr auf den weltweiten Verkauf von D-Fi. Zu dem Syndikat gehören Paragon Biosciences, Valor Equity Partners und XOMA Royalty (Nasdaq: XOMA).
D-Fi, eine injizierbare Therapie, behandelt DEB, eine seltene genetische Hauterkrankung, die durch eine Mutation im COL7A1-Gen verursacht wird. Die Therapie verwendet genetisch modifizierte dermale Fibroblasten, um das COL7-Protein auszudrücken, was die Bildung von Hautverankerungsfibrillen unterstützt. Klinische Studien haben gezeigt, dass D-Fi im Allgemeinen gut verträglich ist, wobei Reaktionen an der Injektionsstelle die Hauptnebenwirkungen darstellen.
D-Fi hat mehrere FDA-Bezeichnungen erhalten, darunter Orphan Drug, Rare Pediatric Disease, Fast Track und Regenerative Medicine Advanced Therapy zur Behandlung der rezessiven dystrophischen Epidermolysis bullosa (RDEB).
- $75M financing for D-Fi Phase 3 trial
- High-single digit royalty on worldwide sales
- FDA designations: Orphan Drug, Rare Pediatric Disease, Fast Track, Regenerative Medicine Advanced Therapy
- Potential adverse reactions: skin discoloration, erythema, hemorrhage, pain, and swelling
Capital will fund Castle Creek’s D-Fi Phase 3 clinical trial for patients with dystrophic epidermolysis bullosa through topline data results
Ligand invested
JUPITER, Fla., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today announced it has closed a royalty financing agreement with Castle Creek Biosciences, Inc. to support the Phase 3 clinical study of D-Fi (FCX-007), Castle Creek’s lead candidate, in patients with dystrophic epidermolysis bullosa (DEB).
Ligand originated, structured, and invested
“Partnering with Castle Creek is an exciting opportunity to advance an orphan drug-designated gene therapy for a serious unmet medical need through Phase 3 development,” said Todd Davis, CEO of Ligand. “This collaboration reflects our commitment to invest in groundbreaking de-risked treatments that can transform patients' lives and expand our diversified portfolio of revenue-generating assets.”
“We are pleased Ligand and our syndicate of investors recognized the potential of this critical therapy, which we believe represents a significant step forward in addressing the needs of patients living with DEB,” commented Matthew Gantz, president and CEO of Castle Creek. “Having a sophisticated investor like Ligand work closely with our extremely supportive equity partners made this transaction to support our Phase 3 clinical trial possible.”
D-Fi is an injectable autologous gene-modified cell therapy candidate for the treatment of DEB, a devastating, progressive, painful, and debilitating rare genetic skin disorder. DEB is caused by a mutation in the COL7A1 gene, leading to a deficiency of normal type VII collagen (COL7) protein, impairing the connection between the epidermis and the dermis. D-Fi is comprised of a patient’s own dermal fibroblasts, which are genetically modified completely ex vivo with a self-inactivating (SIN) lentiviral vector (LV) containing the COL7A1 gene to express COL7. D-Fi is locally administered by intradermal injection into chronic wounds where the COL7 protein can support the formation of anchoring fibrils in the skin. In clinical studies, D-Fi has been generally well tolerated, with injection site reactions (skin discoloration, erythema, hemorrhage, pain, and swelling) being the primarily reported adverse drug reactions. D-Fi was granted Orphan Drug Designation for the treatment of DEB and granted Rare Pediatric Disease, Fast Track, and Regenerative Medicine Advanced Therapy designations for the treatment of recessive dystrophic epidermolysis bullosa (RDEB) by the FDA.
About Castle Creek Biosciences, Inc.
Castle Creek Biosciences is a late-stage company developing re-dosable gene therapies. It is conducting a pivotal clinical trial of its lead candidate for patients with dystrophic epidermolysis bullosa (DEB). Learn more at castlecreekbio.com.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company enabling scientific advancement through supporting the clinical development of high-value medicines. Ligand does this by providing financing, licensing our technologies or both. Its business model seeks to generate value for stockholders by creating a diversified portfolio of biopharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Ligand’s goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable and diversified manner. Its business model focuses on funding programs in mid- to late-stage drug development in return for economic rights, purchasing royalty rights in development stage or commercial biopharmaceutical products and licensing its technology to help partners discover and develop medicines. Ligand partners with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) in order to generate its revenue. Ligand’s Captisol® platform technology is a chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand’s NITRICIL™ platform technology facilitates tunable dosing, permitting an adjustable drug release profile to allow proprietary formulations that target a broad range of indications. Ligand has established multiple alliances, licenses and other business relationships with the world’s leading biopharmaceutical companies including Amgen, Merck, Pfizer, Jazz, Gilead Sciences, and Baxter International. For more information, please visit www.ligand.com. Follow Ligand on X @Ligand_LGND.
We use our investor relations website and X as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Investors should monitor our website and our X account, in addition to following our press releases, SEC filings, public conference calls and webcasts.
Forward-Looking Statements
This news release contains forward-looking statements, as defined in Section 21E of the Securities Exchange Act of 1934, by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. All statements, other than statements of historical fact, could be deemed to be forward-looking statements. In some instances, words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect our good faith beliefs (or those of the indicated third parties) and speak only as of the date hereof. These forward-looking statements include, without limitation, statements regarding: Ligand’s future royalty payments due under its agreement with Castle Creek, the trial and regulatory success of Castle Creek’s upcoming Phase 3 trial of D-Fi for patients with dystrophic epidermolysis bullosa (DEB), the potential high patient impact, and revenue potential of D-Fi; Ligand may not receive expected revenue under its agreement with Castle Creek or others, Ligand or its partners may not be able to protect their intellectual property, and patents covering certain products and technologies may be challenged or invalidated which could expose Ligand to significant liabilities and have a material adverse effect on the company. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other risk factors affecting Ligand can be found in prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release, including the possibility of additional license fees and milestone revenues we may receive. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contacts
For Ligand:
Investors:
Melanie Herman
investors@ligand.com
(858) 550-7761
Media:
Kellie Walsh
media@ligand.com
(914) 315-6072
For Castle Creek Biosciences:
Sheridan Chaney
(312) 847-1323
sc@paragonbiosci.com
FAQ
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