Investors & Media

Cyprium Therapeutics, Inc. (Cyprium) is focused on the development of novel therapies for the treatment of Menkes disease and related copper metabolism disorders. In March 2017, Cyprium entered into a Cooperative Research and Development Agreement (CRADA) with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH), to advance the clinical development of CUTX-101 (Copper Histidinate injection) for the treatment of Menkes disease. In addition, Cyprium and NICHD entered into a worldwide, exclusive license agreement to develop and commercialize adeno-associated virus (AAV)-based gene therapy, called AAV-ATP7A, to deliver working copies of the copper transporter that is defective in Menkes patients, and to be used in combination with CUTX-101. Both CUTX-101 and AAV-ATP7A gene therapy were granted orphan drug designation by the FDA. CUTX-101 was also granted FDA Breakthrough Therapy, Fast Track and Rare Pediatric Disease Designations. Additionally, the European Medicines Agency previously granted Orphan Drug Designation for CUTX-101.

In 2021, Sentynl Therapeutics (Sentynl), a wholly owned subsidiary of Cadila Healthcare Limited (Zydus) and Cyprium executed an asset purchase agreement pursuant to which Sentynl will acquire Cyprium’s proprietary rights to CUTX-101 upon FDA approval thereof. Under the terms of the agreement, Cyprium is eligible to receive up to $20 million in upfront development and regulatory cash milestones through NDA approval. Royalties on CUTX-101 net sales ranging from the mid-single digits up to the mid-twenties are also payable, as well as potential sales milestones. Cyprium will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval for CUTX-101. Cyprium continues to maintain development responsibility for CUTX-101 through approval of the NDA by the FDA, and Sentynl is responsible for commercialization of CUTX-101 as well as progressing newborn screening activities for Menkes disease in the U.S. The development of CUTX-101 is overseen by a Joint Steering Committee consisting of representatives from both companies.

Cyprium is a majority‐owned partner company of Fortress Biotech (NASDAQ: FBIO) and is based in New York City.

Contact Information:

Cyprium Therapeutics, Inc.
2 Gansevoort Street, 9th Floor
New York, NY 10014
www.cypriumtx.com

Investor Relations:

Cyprium Therapeutics, Inc.
Jaclyn Jaffe, Investor Relations
ir@cypriumtx.com