RESEARCH TRIANGLE PARK, N.C., March 26, 2018 (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 business update and financial results for the year ended December 31, 2017.
"After a decade of working together with leading pediatric oncology centers of excellence worldwide, last year proved to be significant for Fennec and for the advancement of PEDMARKTM, potentially the first treatment available to prevent hearing loss in children treated with cisplatin," said Rosty Raykov, President and Chief Executive Officer of Fennec. "The highly statistically significant results reported by SIOPEL 6 confirming the previously reported data from the proof of concept COG ACCL0431 study will form the basis of the marketing applications of PEDMARKTM in the U.S. and EU. To that effect, we are pleased with the recent Fast Track designation of PEDMARKTM by the FDA. Having successfully completed the Nasdaq listing and the $29 million raised in equity financings during 2017, we are well positioned to fully fund our key strategic activities in 2018 and beyond, and we look forward to sharing our progress throughout the year."
SIOPEL 6 top line results presented at SIOP 2017 in Washington, DC.
The SIOPEL 6 study met its primary endpoint. The study demonstrated that the addition of STS significantly reduces the incidence of cisplatin-induced hearing loss without any evidence of tumor protection. Among the 99 evaluable patients, hearing loss occurred in 30/45=67% treated with Cisplatin (Cis) alone and in 20/54=37.0% treated with Cis+STS, corresponding to a relative risk of 0.56 (P=0.0033).
The Company also reported top-line data for secondary endpoints Event Free Survival (EFS) and Overall Survival (OS). With a follow up of 52 months, 3yr EFS is Cis 78.8% and Cis+STS 82.1%; 3yr OS is Cis 92.3% and Cis+STS 98.2%.
Financial Results for the Fourth Quarter and Full Year 2017
- Cash Position - Cash and cash equivalents were $28.3 million as of December 31, 2017 primarily as a result of the $7.6 and $21.2 million (gross proceeds) equity financings completed in June and December 2017, respectively.
- R&D Expenses - Research and development (R&D) expenses were $0.9 million and $1.9 million for the three and twelve months ended December 31, 2017, respectively, compared to $0.2 million and $0.5 million for the three and twelve months ended December 31, 2016, respectively The increase in R&D expenses for both the three and twelve months ended December 31, 2017, is primarily due to the manufacturing and CMC expenses for the potential commercialization of PEDMARKTM.
- G&A Expenses - General and administrative (G&A) expenses were $1.6 million and $5.0 million for the three and twelve months ended December 31, 2017, respectively, as compared to $1.0 million and $2.4 million for the three and twelve months ended December 31, 2016, respectively. The increase in G&A expenses for the three and twelve months ended December 31, 2017 relates primarily to non-cash compensation expenses related to equity incentive expense recognized during 2017.
- Net Loss - Net loss was $2.3 million and $7.0 million for the three and twelve months ended December 31, 2017, respectively, compared to a net loss of $1.1 million and $2.8 million for the three and twelve months ended December 31, 2016, respectively.
- Financial Guidance - The Company believes its cash and cash equivalents on hand as of December 31, 2017 will be sufficient to fund the Company's planned commercial launch of PEDMARKTM in the second half of 2019.
About PEDMARK™ (Sodium Thiosulfate (STS))
Cisplatin and other platinum compounds are essential chemotherapeutic components for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity in many patients, and are particularly harmful to the survivors of pediatric cancer.
