Business
Fennec Pharmaceuticals Announces Third Quarter 2020 Financial Results and Provides Business Update
~ The Company Continues to Work with the FDA and Its Third-Party Drug Product Manufacturer to Fully Address CRL and Prepare NDA Resubmission for PEDMARK™ ~ ~
About this update from Fennec Pharmaceuticals Inc.
[{"type":"text","content":"~ The Company Continues to Work with the FDA and Its Third-Party Drug Product Manufacturer to Fully Address CRL and Prepare NDA Resubmission for PEDMARK™ ~\n ~ No Clinical Safety or Efficacy Issues Identified; No Additional Studies Required for PEDMARK™ ~ ~ The Company Has Approximately $33 Million in Cash and No Outstanding Debt ~ 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™ (a unique formulation of sodium thiosulfate) 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, 202...