Business
Fennec Pharmaceuticals Announces Second 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 $27 Million in Cash and Cash Equivalents ~ RESEARCH TRIANGLE PARK, N.C., Aug. 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 second quarter ended June 30, 2021 and provided a business update. “We are pleased that the FDA has accepted our PEDMARK™ NDA resubmission, and as we work closely with the Agency through the review process, we are also focusing 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. Upcoming Investor Event 2021 Wedbush PacGrow Healthcare Conference – The Company will be presenting on Wednesday, August 11, 2021 at 4:40 p.m. ET. The presentation will be webcast live and can be accessed by visiting the investors relations section of the Company’s website at http://investors.fennecpharma.com/events-and-presentations/presentations. Financial Results for the Second Quarter 2021 Cash Position – Cash and cash equivalents were $27.3 million as of June 30, 2021. The decrease in cash and cash equivalents between June 30, 2021 and December 31, 2020, 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, which were offset by the $5.0 million draw on the Bridge Bank Loan in June 2021. As of June 30, 2021, the Company had $5.0 million in funded debt.Research and Development (R&D) Expenses – R&D expenses were $0.8 million for the second quarter ended June 30, 2021 compared to $1.1 million for the same period in 2020. R&D expenses decreased by $0.3 million for the three months ended June 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 Admin...