Full Press Release Details
FENNEC PROVIDES BUSINESS UPDATE AND ANNOUNCES
FIRST QUARTER 2019 FINANCIAL RESULTS
Research Triangle Park, NC, May 9,
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 its business update and financial results for the first quarter ended March 31, 2019.
"We were very pleased with the production
transition of PEDMARKTM API to the new commercial drug substance manufacturing site during the first quarter."
said Rosty Raykov, chief executive officer of Fennec. "The strength of our cash balance is of utmost importance to us while
we remain on track to complete our submission of the NDA for PEDMARKTM in late 2019 to early 2020. We look forward to
providing further updates on our progress."
Financial Results for the First Quarter
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 interim unaudited consolidated financial statements for the period ended March 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. All values are presented
in thousands unless otherwise noted.
| Three Months Ended | ||||||||
| Interim Unaudited Statement of Operations | March 31, 2019 | March 31, 2018 | ||||||
| (U.S. Dollars in thousands except per share amounts) | ||||||||
| Revenue | $ | - | $ | - | ||||
| Operating expenses | ||||||||
| Research and development | 1,671 | 689 | ||||||
| General and administrative | 1,009 | 1,102 | ||||||
| Loss from operations | (2,680 | ) | (1,791 | ) | ||||
| Unrealized gain/(loss) | - | 167 | ||||||
| Other loss | (12 | ) | (3 | ) | ||||
| Interest income | 66 | 59 | ||||||
| Net loss | $ | (2,626 | ) | $ | (1,568 | ) | ||
| Basic and diluted net loss per common share | $ | (0.13 | ) | $ | (0.09 | ) |
Fennec Pharmaceuticals Inc.
Dollars in thousands)
| March 31, 2019 | December 31, 2018 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 20,231 | $ | 22,781 | ||||
| Other current assets | 112 | 169 | ||||||
| Non-current assets, net | 314 | - | ||||||
| Total Assets | $ | 20,657 | $ | 22,950 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities | $ | 1,451 | $ | 1,637 | ||||
| Derivative liabilities | - | - | ||||||
| Total stockholders' equity | 19,206 | 21,313 | ||||||
| Total liabilities and stockholders' equity | $ | 20,657 | $ | 22,950 |
| Selected Asset and Liability Data: | March 31, 2019 | December 31, 2018 | ||||||
| (U.S. Dollars in thousands) | ||||||||
| Cash and cash equivalents | $ | 20,231 | $ | 22,781 | ||||
| Other current assets | 112 | 169 | ||||||
| Current liabilities | (1,451 | ) | (1,637 | ) | ||||
| Working capital | $ | 18,892 | $ | 21,313 | ||||
| Selected Equity: | ||||||||
| Common stock | $ | 106,392 | $ | 106,392 | ||||
| Accumulated deficit | (133,882 | ) | (131,256 | ) | ||||
| Stockholders' equity | 19,206 | 21,313 |
At March 31, 2019, the Company had working
capital balance totaling approximately $18.9 million compared to $21.3 million as of December 31, 2018.
| Dollar and shares in thousands | Three Months Ended March 31, | |||||||
| Selected cash flow data: | 2019 | 2018 | ||||||
| Net cash used in operating activities | $ | (2,479 | ) | $ | (1,727 | ) | ||
| Net cash used in investing activities | - | - | ||||||
| Net cash (used in)/provided by financing activities | (71 | ) | 186 | |||||
| Decrease in cash and cash equivalents | $ | (2,550 | ) | $ | (1,541 | ) |
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.
For a more detailed discussion of related
risk factors, please refer to our public filings available at www.sec.gov and www.sedar.com.
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.
In the U.S. and Europe there is estimated that over
10,000 children may receive platinum-based chemotherapy. 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 achievement.
STS has been studied by cooperative groups in two Phase 3 clinical
studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies are
completed. The COG ACCL0431 protocol 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.
About Fennec Pharmaceuticals
Pharmaceuticals, Inc., is a specialty pharmaceutical company focused on the development of Sodium Thiosulfate (STS) for the prevention
of platinum-induced ototoxicity in pediatric patients. 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.
For further information, please contact:
Chief Executive Officer
Fennec Pharmaceuticals Inc.