Business
Fennec Pharmaceuticals Announces First Quarter 2022 Financial Results and Provides Business Update
~ FDA Prescription Drug User Fee Act (PDUFA) Target Action Date Set for September 23, 2022 ~ ~ If Approved by the FDA, PEDMARKTM Stands to Be the First
About this update from Fennec Pharmaceuticals Inc.
[{"type":"text","content":"~ FDA Prescription Drug User Fee Act (PDUFA) Target Action Date Set for September 23, 2022 ~ ~ If Approved by the FDA, PEDMARKTM Stands to Be the First Therapy for the Prevention of Cisplatin-Induced Hearing Loss in Children ~ ~ Company Has Approximately $18.3 Million in Cash and $5 Million of Funded Debt ~ RESEARCH TRIANGLE PARK, N.C., May 12, 2022 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in pediatric patients, today reported its financial results for the fiscal quarter ended March 31, 2022 and provided a business update. “We are pleased that the FDA has accepted our resubmission of the NDA for PEDMARK™,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. “While we are working closely with the FDA to facilitate their review of our NDA, we continued to execute against key initiatives across our commercial, clinical, and manufacturing operations. Our commercial team is actively preparing for launch readiness as we await a decision from the FDA by the September 23, 2022 PDUFA target action date.” Upcoming Investor Event Annual Meeting of Shareholders – Fennec would like to invite shareholders to attend its Annual General Meeting on Tuesday, June 14, 2022 at 11:00 a.m. ET, which will be held in person at The Fifty Sonesta Select Hotel, The Den Room, 155 East 50th Street at Third Avenue, New York, NY 10022, USA, or online by visiting www.virtualshareholdermeeting.com/FENC2022. Financial Results for the First Quarter 2022 Cash Position – Cash and cash equivalents were $18.3 million as of March 31, 2022. The decrease in cash and cash equivalents between March 31, 2022 and December 31, 2021, is the result of expenses related to the development and preparation of our New Drug Application (NDA) resubmission of PEDMARK™ and general and administrative expenses.Research and Development (R&D) Expenses – R&D expenses were $1.4 million for the first quarter ended March 31, 2022 compared to $2.4 million for the same period in 2021. R&D expenses decreased by $1.0 million for the three months ended March 31, 2022 over the same period in 2021 as the Company’s development activities decreased Company’s as efforts on year ove...