RESEARCH TRIANGLE PARK, N.C., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (Nasdaq:FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARK for the prevention of platinum-induced ototoxicity in pediatric patients, today reported its financial results for the third quarter ended September 30, 2020 and provided a business update.

“We are pleased with the recent constructive and collaborative Type A meeting with the FDA to discuss the path forward for resubmission of the New Drug Application (NDA) for PEDMARK™ for the prevention of life-long hearing loss for children receiving cisplatin chemotherapy,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. “Importantly, there were no clinical or safety issues identified in the complete response letter (CRL) and there are no requirements for additional clinical data within the CRL. We are working closely with the FDA and our third-party drug product manufacturer to fully address the CRL and plan to resubmit the NDA for PEDMARK™ with the goal of achieving regulatory approval and making PEDMARK™ commercially available to patients in need as quickly as possible.”

Financial Results for the Third Quarter 2020

• Cash Position – Cash and cash equivalents were $33.2 million as of September 30, 2020. The reduction in cash balance is the result of cash used for operating activities including regulatory activities of PEDMARK™ and expenses associated with commercial and operational launch preparation during the quarter. As of September 30, 2020, the Company has no funded debt.
• Research and Development (R&D) Expenses – R&D expenses were $1.4 million for the third quarter ended September 30, 2020, compared to $0.8 million for the same period in 2019. The increase in R&D in the quarter was due to an increase in R&D expenses after the Complete Response Letter (CRL).
• General and Administrative (G&A) Expenses – G&A expenses for the third quarter ended September 30, 2020, increased by $3.4 million over the same period in 2019, reflecting the Company’s focus on commercialization readiness of PEDMARK™. The increase in G&A during the quarter was primarily due to commercialization readiness activities during the quarter leading up to the PDUFA date of PEDMARK in August 2020.
• Net Loss – Net loss for the quarter ended September 30, 2020 was $6.2 million ($0.24 per share), compared to $1.8 million ($0.09 per share) for the same period in 2019.

Financial Update

The selected financial data presented below are derived from our unaudited condensed consolidated financial statements, which were prepared in accordance with U.S. generally accepted accounting principles. The complete unaudited condensed consolidated financial statements for the period ended September 30, 2020 and management's discussion and analysis of financial condition and results of operations will be available via www.sec.gov and www.sedar.com. All values are presented in thousands unless otherwise noted.

About PEDMARK™

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 Marketing Authorization Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) 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.

About Fennec Pharmaceuticals

Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development of PEDMARK™ for the prevention of platinum-induced ototoxicity in pediatric patients. Further, PEDMARK has received Orphan Drug Designation in the U.S. for this potential use. Fennec has a license agreement with Oregon Health and Science University (OHSU) for exclusive worldwide license rights to intellectual property directed to sodium thiosulfate and its use for chemoprotection, including the prevention of ototoxicity induced by platinum chemotherapy, in humans. For more information, please visit www.fennecpharma.com