Cyprium Therapeutics, a Fortress Biotech Partner Company, and Sentynl Therapeutics, a Wholly-owned Subsidiary of the Zydus Group, Sign Development and Asset Purchase Agreement for Cyprium Therapeutics’ Copper Histidinate Product Candidate for Treatment of - Seite 2

Matt Heck, Co-founder, President & Chief Executive Officer of Sentynl, commented, “Our mission, at the Zydus Group, has been to provide healthcare professionals with access to innovative treatment solutions that enable them to meet the needs of individual patients. We are excited to collaborate with Cyprium in order to broaden our pediatric rare disease portfolio and commercialize CUTX-101, a potentially transformative product, for children with Menkes disease, an unmet healthcare need.”

Fortress’ Chairman, President and Chief Executive Officer, Lindsay A. Rosenwald, M.D., added, “This transaction with Sentynl further validates the Fortress business model of identifying and developing promising treatments for patients, while pursuing partnership opportunities that potentially maximize shareholder value. We are thrilled with the progress Cyprium has made developing this treatment for Menkes disease and look forward to working with Sentynl to make CUTX-101 available to patients.”

Under the agreement, Cyprium is eligible to receive up to $20 million in upfront development and regulatory cash milestones through NDA approval, as well as potential sales milestones. Royalties on CUTX-101 net sales ranging from the mid-single digits up to the mid-twenties are also payable. Cyprium will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval for CUTX-101. Torreya Partners advised Cyprium on this transaction.

About Menkes Disease
Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of copper transporter ATP7A. The minimum birth prevalence for Menkes disease is believed to be 1 in 34,810 live male births, and potentially as high as 1 in 8,664 live male births, based on recent genome-based ascertainment (Kaler SG, Ferreira CR, Yam LS. Estimated birth prevalence of Menkes disease and ATP7A-related disorders based on the Genome Aggregation Database (gnomAD). Molecular Genetics and Metabolism Reports 2020 June 5;24:100602). The condition is characterized by distinctive clinical features, including sparse and depigmented hair (“kinky hair”), connective tissue problems, and severe neurological symptoms such as seizures, hypotonia, failure to thrive, and neurodevelopmental delays. Mortality is high in untreated Menkes disease, with many patients dying before the age of three years old. Milder versions of ATP7A mutations are associated with other conditions, including Occipital Horn Syndrome and ATP7A-related Distal Motor Neuropathy. Currently, there is no FDA-approved treatment for Menkes disease and its variants.