Business
Fennec Pharmaceuticals Announces Second Quarter 2020 Financial Results and Provides Business Update
~ FDA Set a PDUFA Target Action Date for PEDMARKTM of August 10, 2020 ~~ Strong Financial Position with $38.7 million in cash and no debt ~ RESEARCH TRIANGLE
About this update from Fennec Pharmaceuticals Inc.
[{"type":"text","content":"~ FDA Set a PDUFA Target Action Date for PEDMARKTM of August 10, 2020 ~~ Strong Financial Position with $38.7 million in cash and no debt ~\n RESEARCH TRIANGLE PARK, N.C., Aug. 05, 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 second quarter ended June 30, 2020 and provided a business update. “We continue to work with the FDA as a part of their review process in advance of the pending PEDMARKTM PDUFA date of August 10,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. \"Our organization and commercial team have been actively preparing for launch readiness, and, as we await the FDA’s decision, we believe that we are well positioned to commercialize PEDMARK, if approved, during the third quarter of 2020.” Financial Results for the First Quarter 2020 Cash Position – Cash and cash equivalents were $38.7 million as of June 30, 2020. The increase in cash balance is the result of the Company raising approximately $32 million in net proceeds through a public offering in May 2020. This increase in cash balance was offset by cash used for operating activities including regulatory submissions of PEDMARKTM and expenses associated with commercial and operational launch preparation. As of June 30, 2020, the Company has no funded debt.Research and Development (R&D) Expenses – R&D expenses were $1.1 million for the second quarter ended June 30, 2020, compared to $2.0 million for the same period in 2019. The Company has completed most of the activities needed for regulatory approval of PEDMARKTM and a significant amount of its activities are now focused on commercialization readiness in preparation for the potential launch of PEDMARKTM.General and Administrative (G&A) Expenses – G&A expenses for the second quarter ended June 30, 2020, increased by $0.9 million over the same period in 2019, reflecting the Company’s focus on commercializing PEDMARKTM. The increase in G&A during the quarter was primarily due to commercialization readiness activities and increased headcount which was partially offset by reduced non-cash equity compensation.Net Loss – Net loss for...