Business
Fennec Pharmaceuticals Announces Third Quarter 2021 Financial Results and Provides Business Update
~ FDA Prescription Drug User Fee Act (PDUFA) Target Action Date Set for November 27, 2021 ~ ~ If Approved by the FDA, PEDMARK™ Stands to Be the First Therapy
About this update from Fennec Pharmaceuticals Inc.
[{"type":"text","content":"~ FDA Prescription Drug User Fee Act (PDUFA) Target Action Date Set for November 27, 2021 ~ ~ If Approved by the FDA, PEDMARK™ Stands to Be the First Therapy for the Prevention of Cisplatin-Induced Hearing Loss in Children ~ ~ Company Has Approximately $24 Million in Cash and Cash Equivalents ~ RESEARCH TRIANGLE PARK, N.C., Nov. 10, 2021 (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, 2021 and provided a business update. “We continue to work with the FDA on their review of our NDA application, in advance of the pending PEDMARK™ PDUFA target action date of November 27th. We are focused on essential activities in preparation to bring this important treatment to children receiving cisplatin chemotherapy,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals, Inc. Financial Results for the Third Quarter 2021 Cash Position – Cash and cash equivalents were $24.3 million as of September 30, 2021. The decrease in cash and cash equivalents between September 30, 2021, and June 30, 2020 is the result of expenses related to the development and preparation of the NDA resubmission of PEDMARK™ and general and administrative expenses. As of September 30, 2021, the Company had $5.0 million in funded debt.Research and Development (R&D) Expenses – R&D expenses were $1.2 million for the third quarter ended September 30, 2021 compared to $1.4 million for the same period in 2020. R&D expenses decreased by $0.2 million for the three months ended September 30, 2021 over the same period in 2020 as the Company’s development activities shifted back to essential activities in preparation for the launch of PEDMARK™.General and Administrative (G&A) Expenses – G&A expenses decreased by $1.6 million over same period in 2020 due to the timing to NDA approval of the comparative periods. The three months ended September 30, 2020 was the same quarter as the initial NDA approval and the three months ended September 30, 2021 is one quarter prior to our current potential NDA approval. The reduction in general and administrative expenses was slightly offset by ...