RESEARCH TRIANGLE PARK, N.C., Feb. 14, 2020 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (Nasdaq: FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARK^TM (a unique formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in pediatric patients, today reported its business update and financial results for the fiscal year ended December 31, 2019.

"Fennec made great progress in 2019 preparing for some important milestones in 2020 including the recent announcement of regulatory submissions in both the U.S. and EU for PEDMARK” said Rosty Raykov, chief executive officer of Fennec. "During the year we also made solid progress in preparing for the potential launch of PEDMARK including the hiring of a chief commercial officer and the preparation and execution of our commercial readiness plan. We look forward to a number of significant milestones throughout 2020. If PEDMARK is granted a Priority Review, the Prescription Drug User Fee Act (PDUFA) action date is expected in the third quarter of 2020.”

Financial Results for the Fourth Quarter 2019

• Cash Position - Cash and cash equivalents were $13.7 million as of December 31, 2019. The reduction in cash balance over the fiscal year is the result of cash used for operating activities including regulatory expenses associated with the regulatory submissions of PEDMARK and expenses associated with commercial launch preparation.
• Research and Development (R&D) Expenses – R&D expenses were $1.2 million and $5.6 million, respectively, for the fourth quarter and year ended December 31, 2019, compared to $1.7 million and $5.0 million for the same period in 2018. The Company completed a significant part of the activities needed for regulatory approval of PEDMARK during the fourth quarter of 2019.
• General and Administrative (G&A) Expenses – G&A expenses were $2.5 million and $7.4 million, respectively, for the fourth quarter and year ended December 31, 2019, compared to $1.4 million and $5.4 million, respectively for the same periods in 2018. Fourth quarter increase in G&A was largely attributable to the commercialization efforts as the Company prepares to bring PEDMARK, if approved, to market in the second half of 2020. An additional increase in G&A expenses is attributed to a small rise in compensation to officers, directors and key contract employees in fiscal 2019 as compared to fiscal 2018. Shareholders passed a motion to increase the duration of all outstanding option contracts to a total of 10 years in 2019. This added $1.3 million in G&A in non-cash compensation over the prior year. Sales and marketing expenses increased by $0.4 million over the prior year as the Company began to focus efforts to commercialize PEDMARK. The company incurred approximately $0.25 million in additional administrative expenses as it added positions to the commercial team including the addition of a Chief Commercial Officer.
• Net Loss - Net losses for the fourth quarter and year ended December 31, 2019 of $3.6 million ($0.18 per share) and $12.8 million ($0.64 per share), respectively, compared to $3.0 million ($0.15 per share) and $9.9 million ($0.52 per share), respectively, for the same periods in 2018.
• Financial Guidance - The Company believes its cash and cash equivalents on hand as of December 31, 2019, along with the $12.5 million loan facility available upon FDA approval of PEDMARK^TM will be sufficient to fund the Company's planned commercial launch of PEDMARK^TM in the second half of 2020.

Financial Update

The selected financial data presented below is derived from our unaudited condensed consolidated financial statements which were prepared in accordance with U.S. generally accepted accounting principles. The complete audited condensed consolidated financial statements for the period ended December 31, 2019 and management's discussion and analysis of financial condition and results of operations will be available via www.sec.gov and www.sedar.com.