Full Press Release Details
FENNEC PROVIDES BUSINESS UPDATE AND ANNOUNCES FISCAL YEAR
2018 FINANCIAL RESULTS
Research Triangle Park, NC, March
13, 2019 - 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 financial results for the fiscal year ended December 31, 2018.
"Throughout 2018 we were pleased to
continue making progress on the advance of PEDMARKTM towards regulatory approval in the U.S. and EU," said Rosty
Raykov, chief executive officer of Fennec. "Major accomplishments over the year included approval of our Pediatric Investigation
Plan, confirmation of Pediatric Use Marketing Authorization eligibility in the EU and the initiation of our NDA in the U.S. This
year, we remain focused on finalizing submissions in both the U.S. and EU and preparations for the potential launch of PEDMARKTM
Recent Corporate Highlights and Upcoming
Fourth Quarter and Year End 2018
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, 2018 and management's discussion and analysis of financial condition and results of operations will be available via www.sec.gov
and www.sedar.com. All values are presented in thousands unless otherwise noted.
Audited Condensed Consolidated
Statement of Operations:
(U.S. Dollars in thousands except per share amounts)
| Three Months Ended | Twelve Months Ended | |||||||||||||||
| December 31, | December 31, | December 31, | December 31, | |||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Revenue | $ | - | $ | - | $ | - | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,723 | 886 | 5,008 | 1,936 | ||||||||||||
| General and administrative | 1,382 | 1,629 | 5,401 | 5,015 | ||||||||||||
| Loss from operations | (3,105 | ) | (2,515 | ) | (10,409 | ) | (6,951 | ) | ||||||||
| Other (expense)/income | ||||||||||||||||
| Unrealized gain/(loss) on derivatives | - | 206 | 167 | (134 | ) | |||||||||||
| Other loss | 6 | (4 | ) | 6 | (8 | ) | ||||||||||
| Net interest income | 115 | 23 | 348 | 47 | ||||||||||||
| Total other (expense)/income, net | 121 | 225 | 521 | (95 | ) | |||||||||||
| Net income/(loss) | $ | (2,984 | ) | $ | (2,290 | ) | $ | (9,888 | ) | $ | (7,046 | ) | ||||
| Basic net income/(loss) per common share | $ | (0.15 | ) | $ | (0.15 | ) | $ | (0.52 | ) | $ | (0.47 | ) | ||||
| Diluted net income/(loss) per common share | $ | (0.15 | ) | $ | (0.15 | ) | $ | (0.52 | ) | $ | (0.47 | ) |
| Fennec Pharmaceuticals Inc. | ||||||||
| Balance Sheets | ||||||||
| (U.S. Dollars in thousands) | ||||||||
| December 31, 2018 | December 31, 2017 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 22,781 | $ | 28,260 | ||||
| Other current assets | 169 | 141 | ||||||
| Total Assets | $ | 22,950 | $ | 28,401 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities | $ | 1,637 | $ | 1,477 | ||||
| Derivative liabilities | - | 167 | ||||||
| Total stockholders' equity | 21,313 | 26,757 | ||||||
| Total liabilities and stockholders' equity | $ | 22,950 | $ | 28,401 |
| Working Capital | Fiscal Year Ended | |||||||
| Selected Asset and Liability Data: | December 31, 2018 | December 31, 2017 | ||||||
| (U.S. Dollars in thousands) | ||||||||
| Cash and cash equivalents | $ | 22,781 | $ | 28,260 | ||||
| Other current assets | 169 | 141 | ||||||
| Current liabilities excluding derivative liability | (1,637 | ) | (1,477 | ) | ||||
| Working capital | $ | 21,313 | $ | 26,924 | ||||
| Selected Equity: | ||||||||
| Common stock & APIC | $ | 151,326 | $ | 146,882 | ||||
| Accumulated deficit | (131,256 | ) | (121,368 | ) | ||||
| Stockholders' equity | 21,313 | 26,757 |
About PEDMARKTM (sodium
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.
Each year in the U.S. and Europe there
is estimated that over 10,000 children with solid tumors are treated with platinum agents. The vast majority of these newly
diagnosed tumors are localized and classified as low to intermediate risk in nature. These localized cancers may have overall survival
rates of greater than 80%, further emphasizing the importance of quality of life after treatment. The incidence of hearing loss
in these children depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids.
There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal
cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children at critical stages of development
lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational
STS has been studied by cooperative
groups in two Phase 3 clinical studies of survival and reduction of ototoxicity: COG ACCL0431 and SIOPEL 6. Both studies are closed
to recruitment. COG ACCL0431 enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized
and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma.
SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors. COG ACCL0431 final results were published in the Lancet Oncology.
SIOPEL 6 final results were published in the New England Journal of Medicine.
About Fennec Pharmaceuticals
Fennec Pharmaceuticals Inc., is 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. STS has received Orphan Drug Designation in the US in this setting. Further,
PEDMARKTM received Breakthrough Therapy and Fast Track Designation by the FDA in March 2018. Fennec has a license
agreement with Oregon Health and Science University (OHSU) for exclusive worldwide license rights to intellectual property directed
to STS and its use for chemoprotection, including the prevention of ototoxicity induced by platinum chemotherapy, in humans. For
more information, please visit www.fennecpharma.com.
Forward looking statements
Except for historical information described
in this press release, all other statements are forward-looking. Forward-looking statements are subject to certain risks and uncertainties
inherent in the Company's business that could cause actual results to vary, including such risks that regulatory and guideline
developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances
or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company's patents
and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company's
products will not be as large as expected, the Company's products will not be able to penetrate one or more targeted markets,
revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital requirements
in different countries and municipalities, and other risks detailed from time to time in the Company's filings with the Securities
and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2018. Fennec Pharmaceuticals,
Inc. disclaims any obligation to update these forward-looking statements except as required by law.
The scientific information discussed
in this news release related to PEDMARKTM is preliminary and investigative. Such product candidates are not approved
by the U.S. Food and Drug Administration, Health Canada or other regulatory and no conclusions can or should be drawn regarding
the safety or effectiveness of such product candidate.
For a more detailed discussion of related
risk factors, please refer to our public filings available at www.sec.gov and www.sedar.com.
For further information, please contact:
Chief Executive Officer
Fennec Pharmaceuticals Inc.