- NDA (New Drug Application) for PEDMARKTM to be completed in early 2020
- Strong financial position with $15.2 million in cash and no debt
Research Triangle Park, NC, November 12, 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 third quarter ended September 30, 2019.
“We are nearing completion of the NDA for PEDMARK and expect to complete the rolling submission to the FDA in early 2020” said Rosty Raykov, chief executive officer of Fennec. “With the addition of a chief commercial officer during the quarter, we are focused on building the necessary team and infrastructure to support a rapid commercial launch of PEDMARK, if approved, in the second half of 2020.”
Financial Results for the Third Quarter 2019
- Cash Position – Cash and cash equivalents were $15.2 million as of September 30, 2019. The reduction in cash balance over the quarter is the result of cash used for operating activities including the manufacturing and regulatory expenses associated with the regulatory submissions of PEDMARKTM.
- R&D Expenses – Research and development (R&D) expenses were $0.8 million for the three months ended September 30, 2019, compared to $1.8 million for the same period in 2018 as the Company completed a significant part of the activities needed for regulatory approval of PEDMARKTM during the first six months of 2019.
- G&A Expenses – General and administrative (G&A) expenses were $1.1 million for the three months ended September 30, 2019, and $1.1 million for the same period in 2018.
- Net Loss – Net loss was $1.8 million and $2.7 million for the three months ended September 30, 2019 and 2018, respectively.
- Financial Guidance – The Company believes its cash and cash equivalents on hand as of September 30, 2019 will be sufficient to fund the Company’s planned commercial launch of PEDMARKTM in the second half of 2020.
Financial Update
The selected financial data presented below is derived from our audited 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 September 30, 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 | September 30, 2019 |
September 30, 2018 |
|
| (U.S. Dollars in thousands except per share amounts) | |||
| Revenue |
$ – |
$ – |
|
| Operating expenses | |||
| Research and development |
795 |
1,798 | |
| General and administrative |
1,068 |
1,050 |
|
| Loss from operations | (1,863) | (2,848) | |
| Other loss |
1 |
(2) |
|
|
Amortization expense |
(17) |
– |
|
| Interest income |
70 |
101 |
|
| Net loss | $ (1,809) | $ (2,749) | |
| Basic and diluted net loss per common share | $ (0.09) | $ (0.14) | |
| Fennec Pharmaceuticals Inc. | |||
| Balance Sheets | |||
| (U.S. Dollars in thousands) | |||
|
September 30, 2019 |
December 31, 2018 |
||
| Assets | |||
| Cash and cash equivalents |
$ 15,240 |
$ 22,781 |
|
| Other current assets |
387 |
169 |
|
| Non-current assets, net |
280 |
– |
|
| Total Assets |
$ 15,907 |
$ 22,950 |
|
| Liabilities and stockholders’ equity | |||
| Current liabilities |
$ 905 |
$ 1,637 |
|
| Total stockholders’ equity |
15,002 |
21,313 |
|
| Total liabilities and stockholders’ equity |
$ 15,907 |
$ 22,950 |
|
| Working Capital | |||
| Selected Asset and Liability Data: |
September 30, 2019 |
December 31, 2018 |
|
| (U.S. Dollars in thousands) | |||
| Cash and cash equivalents |
$ 15,240 |
$ 22,781 |
|
| Other current assets |
387 |
169 |
|
| Current liabilities |
(905) |
(1,637) |
|
| Working capital |
$ 14,722 |
$ 21,313 |
|
| Selected Equity: | |||
| Common stock |
$ 106,392 |
$ 106,392 |
|
| Accumulated deficit |
(140,421) |
(131,256) |
|
| Stockholders’ equity |
15,002 |
21,313 |
|
At September 30, 2019, the Company had working capital balance totaling approximately $14.7 million compared to $21.3 million as of December 31, 2018.
| Dollar and shares in thousands
Selected cash flow data: |
Three Months Ended September 30, |
||
| 2019 |
2018 |
||
| Net cash used in operating activities |
$ (2,235) |
$ (1,599) |
|
| Net cash used in investing activities |
– |
– |
|
| Net cash (used in)/provided by financing activities |
– |
483 |
|
| Decrease in cash and cash equivalents |
$ (2,235) |
$ (1,116) |
|
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
Fennec 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:
Rosty Raykov
Chief Executive Officer
Fennec Pharmaceuticals Inc.
T: (919) 636-5144