Fennec Pharmaceuticals Announces Amendment to Increase Existing Senior Debt Facility
RESEARCH TRIANGLE PARK, N.C., June 26, 2020 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARK™ (a unique formulation of sodium thiosulfate) for the prevention of platinum-induced ototoxicity in pediatric patients, today announced an amendment to its existing senior debt facility with the Life Sciences Group at Bridge Bank increasing the size of the facility from $12.5 million to $18 million.
The U.S. operating subsidiary of Fennec Pharmaceuticals Inc., entered into a First Amendment to the 2019 Loan and Security Agreement with Bridge Bank. This amendment provides Fennec with an $18 million debt facility comprised of two term loans. Term Loan A consists of $12.5 million to be funded upon New Drug Application (NDA) approval of PEDMARK™ in the U.S. Term Loan B consists of $5.5 million to be funded upon the occurrence of a revenue event in 2021. The interest-only period for the facility has the ability to be extended from 18 months to 24 months from the funding of Term Loan A, provided that Term Loan B is funded and certain conditions are met. The Company intends to use the proceeds from the loans to provide working capital for commercialization activities for PEDMARK™ upon NDA approval.
“This loan amendment further strengthens our balance sheet and provides us with additional operating capital and flexibility as we prepare for the launch of PEDMARK™, if approved, in the second half of 2020,” said Robert Andrade, chief financial officer of Fennec Pharmaceuticals. “We are pleased to expand our relationship with Bridge Bank, a premier lending institution with a broad scope of services.”
“We have been working with Fennec for the past two years and are excited to continue working with the company as they transition to becoming a commercial-stage organization,” said Ms. Lindsay Fouty, vice president in Bridge Bank’s Life Sciences Group. “We are pleased to provide flexible debt capital to support the launch of PEDMARK™, which addresses an important unmet medical need for the prevention of ototoxicity in children receiving cisplatin chemotherapy.”
About Fennec Pharmaceuticals
Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible and particularly harmful to the survivors of pediatric cancer.
In the U.S. and Europe, it is estimated that, annually, over 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.
PEDMARK has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.
The FDA has accepted for filing the Company’s New Drug Application (NDA) for PEDMARK™ and has granted Priority Review. The Marketing Authorization Application (MAA) for Pedmarqsi (EU tradename) is currently under evaluation by the European Medicines Agency (EMA). PEDMARK has received Breakthrough Therapy and Fast Track Designation by the FDA in March 2018, and a Prescription Drug User Fee Act (PDUFA) Target Action Date of August 10, 2020.
About Bridge Bank
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Fennec Pharmaceuticals Inc.
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