Business
Fennec Announces Fiscal Year 2020 Financial Results and Provides Business Update
~ Fennec is Working Closely with its Third-Party Drug Product Manufacturer to Finalize the New Drug Application (NDA) Resubmission for PEDMARK™ ~ ~
About this update from Fennec Pharmaceuticals Inc.
[{"type":"text","content":"~ Fennec is Working Closely with its Third-Party Drug Product Manufacturer to Finalize the New Drug Application (NDA) Resubmission for PEDMARK™ ~ ~ Resubmission of the NDA for PEDMARKTM is Planned for the Second Quarter of 2021 ~ ~ Company Has Approximately $30 Million in Cash and No Outstanding Debt ~ RESEARCH TRIANGLE PARK, N.C., March 30, 2021 (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 year ended December 31, 2020 and provided a business update. “We have made meaningful progress working with the FDA and our third-party drug product manufacturer towards fully addressing the Complete Response Letter (CRL) received in August 2020 for PEDMARKTM. We believe we are on track to finalize and resubmit the New Drug Application (NDA) for PEDMARK to the FDA in the second quarter of 2021,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. “Importantly and as previously announced, the CRL identified no clinical or safety issues and there are no requirements for additional clinical data. We remain committed to making PEDMARK commercially available to help prevent life-long hearing loss for children receiving cisplatin chemotherapy.” Financial Results for the Fourth Quarter and Fiscal Year Ended December 31, 2020 Cash Position – Cash and cash equivalents were $30.3 million as of December 31, 2020. The net increase in cash balance over the fiscal year is the result of an equity financing of $32 million in net proceeds completed in May 2020, which was offset by cash used for operating activities including regulatory expenses associated with the regulatory submissions of PEDMARKTM and expenses associated with commercial launch readiness.Revenue – Fennec earned royalty revenue originating from the 2016 sales agreement of Eniluracil to Elion Oncology, LLC. The agreement entitles Fennec to a five percent share of gross amounts earned by Elion with respect to Eniluracil. During 2020, the Company received common shares and cash valued at approximately $0.17 million.Research and Development (R&D) Expenses – R&D expenses were $1.2 and $5.1 million, respec...