Business
Fennec Pharmaceuticals Announces First Quarter 2020 Financial Results and Provides Business Update
~ FDA Set a PDUFA Target Action Date for PEDMARKTM of August 10, 2020 ~~ Marketing Authorization Application (MAA) Validated by the EMA in February 2020 ~~
About this update from Fennec Pharmaceuticals Inc.
[{"type":"text","content":"~ FDA Set a PDUFA Target Action Date for PEDMARKTM of August 10, 2020 ~~ Marketing Authorization Application (MAA) Validated by the EMA in February 2020 ~~ Strengthened its Financial Position Through a Raise of Approximately $32 Million in Net Proceeds ~~ Commercial Readiness Activities are Underway in the U.S. ~\n RESEARCH TRIANGLE PARK, N.C., May 14, 2020 (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) for the prevention of platinum-induced ototoxicity in pediatric patients, today reported its financial results for the first quarter ended March 31, 2020 and provided a business update. “We continue our strong momentum across our operations throughout early 2020,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. \"Following the recent announcement of regulatory submission in the U.S. in February, we were pleased to have been granted Priority Review and a PDUFA date of August 10, 2020. Further, we continue to make progress on our commercial readiness plan in preparation for the potential launch of PEDMARK, if approved, in the second half of 2020. Finally, we significantly strengthened our balance sheet with an over-subscribed follow-on public offering that will allow us to support the commercial launch of PEDMARK and the potential growth period ahead.” Investor Events Annual Meeting of Shareholders – Fennec would like to invite all shareholders to attend its Annual General and Special Meeting on Monday, June 22, 2020 at 12 pm EDT, which will be held online by visiting www.virtualshareholdermeeting.com/FENC2020. Financial Results for the First Quarter 2020 Cash Position – Cash and cash equivalents were $9.9 million as of March 31, 2020. The reduction in cash balance is the result of cash used for operating activities including regulatory expenses associated with the regulatory submissions of PEDMARKTM and expenses associated with commercial launch preparation. Subsequent to the closing of Q1 2020, the Company raised approximately $32 million in net proceeds through a public offering of common stock in May 2020. The Company has no funded debt.Research and Development (R&D) Expenses – R&D expenses were $1.4 million for the first quarter ended March 31, 2020, compared to...