~ FDA Set a PDUFA Target Action Date for PEDMARKTM of August 10, 2020 ~
~ Strong Financial Position with $38.7 million in cash and no debt ~
Research Triangle Park, NC, August 5, 2020 – Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate) for the prevention of platinum-induced ototoxicity in pediatric patients, today reported its financial results for the second quarter ended June 30, 2020 and provided a business update.
“We continue to work with the FDA as a part of their review process in advance of the pending PEDMARKTM PDUFA date of August 10,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. “Our organization and commercial team have been actively preparing for launch readiness, and, as we await the FDA’s decision, we believe that we are well positioned to commercialize PEDMARK, if approved, during the third quarter of 2020.”
Financial Results for the First Quarter 2020
- Cash Position – Cash and cash equivalents were $38.7 million as of June 30, 2020. The increase in cash balance is the result of the Company raising approximately $32 million in net proceeds through a public offering in May 2020. This increase in cash balance was offset by cash used for operating activities including regulatory submissions of PEDMARKTM and expenses associated with commercial and operational launch preparation. As of June 30, 2020, the Company has no funded debt.
- Research and Development (R&D) Expenses – R&D expenses were $1.1 million for the second quarter ended June 30, 2020, compared to $2.0 million for the same period in 2019. The Company has completed most of the activities needed for regulatory approval of PEDMARKTM and a significant amount of its activities are now focused on commercialization readiness in preparation for the potential launch of PEDMARKTM.
- General and Administrative (G&A) Expenses – G&A expenses for the second quarter ended June 30, 2020, increased by $0.9 million over the same period in 2019, reflecting the Company’s focus on commercializing PEDMARKTM. The increase in G&A during the quarter was primarily due to commercialization readiness activities and increased headcount which was partially offset by reduced non-cash equity compensation.
- Net Loss – Net loss for the quarter ended June 30, 2020 was $4.8 million ($0.21 per share), compared to $4.7 million ($0.24 per share) for the same period in 2019.
Financial Update
The selected financial data presented below are derived from our unaudited condensed consolidated financial statements, which were prepared in accordance with U.S. generally accepted accounting principles. The complete unaudited condensed consolidated financial statements for the period ended June 30, 2020 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.
Unaudited Condensed Consolidated
Statements of Operations:
(U.S. Dollars in thousands except per share amounts)
|
Three Months Ended |
|||||||||
| June 30, | June 30, | ||||||||
| 2020 |
2019 |
||||||||
| Revenue | $ |
– |
$ |
– |
|||||
| Operating expenses: | |||||||||
| Research and development |
1,121 |
1,969 |
|||||||
| General and administrative |
3,724 |
2,844 |
|||||||
| Loss from operations |
(4,845 |
) |
(4,813 |
) | |||||
| Other (expense)/income | |||||||||
| Amortization expense |
(30 |
) |
(17 |
) | |||||
| Other loss |
13 |
(10 |
) | ||||||
| Net interest income |
17 |
110 |
|||||||
| Total other income, net |
– |
83 |
|||||||
| Net (loss) | $ |
(4,845 |
) | $ |
(4,730 |
) | |||
| Basic net (loss) per common share | $ |
(0.21 |
) | $ | (0.24 | ) |
|
||
| Diluted net (loss) per common share | $ |
(0.21 |
) | $ |
(0.24 |
) | |||
| Fennec Pharmaceuticals Inc. | ||||||||||||||||||||||
| Balance Sheets | ||||||||||||||||||||||
| (U.S. Dollars in thousands) | ||||||||||||||||||||||
|
Unaudited June 30, 2020 |
Audited December 31, 2019 |
|||||||||||||||||||||
| Assets | ||||||||||||||||||||||
| Cash and cash equivalents | $ |
38,729 |
$ |
13,650 |
||||||||||||||||||
| Other current assets |
170 |
234 |
||||||||||||||||||||
| Non-current assets, net |
417 |
262 |
|
|||||||||||||||||||
| Total Assets | $ |
39,316 |
$ |
14,146 |
||||||||||||||||||
| Liabilities and stockholders’ equity | ||||||||||||||||||||||
| Current liabilities | $ |
3,190 |
$ |
2,271 |
||||||||||||||||||
| Total stockholders’ equity |
36,126 |
11,875 |
||||||||||||||||||||
| Total liabilities and stockholders’ equity | $ |
39,316 |
$ |
14,146 |
||||||||||||||||||
| Working Capital |
Fiscal Year Ended |
|||||||
| Selected Asset and Liability Data: |
June 30, 2020 |
December 31, 2019 |
||||||
| (U.S. Dollars in thousands) | ||||||||
| Cash and cash equivalents | $ |
38,729 |
$ |
13,650 |
||||
| Other current assets |
170 |
234 |
||||||
| Current liabilities |
(3,190 |
) |
(2,271 |
) | ||||
| Working capital | $ | 35,709 | $ | 11,613 | ||||
| Selected Equity: | ||||||||
| Common stock & APIC | $ |
187,585 |
$ |
154,663 |
||||
| Accumulated deficit |
(152,702 |
) | (144,031 |
) |
||||
| Stockholders’ equity |
36,126 |
11,875 |
||||||
About PEDMARK™
Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible and particularly harmful to the survivors of pediatric cancer.
In the U.S. and Europe, it is estimated that, annually, over 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity 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 that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.
PEDMARK 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 have been 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.
The FDA has accepted for filing the Company’s New Drug Application (NDA) for PEDMARK™ and has granted Priority Review. The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename to be determined) is currently under evaluation by the European Medicines Agency (EMA). PEDMARK has received Breakthrough Therapy and Fast Track Designation by the FDA in March 2018, and a Prescription Drug User Fee Act (PDUFA) Target Action Date of August 10, 2020
About Fennec Pharmaceuticals
Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development of PEDMARK™ for the prevention of platinum-induced ototoxicity in pediatric patients. Further, PEDMARK has received Orphan Drug Designation in the U.S. for this potential use. Fennec has a license agreement with Oregon Health and Science University (OHSU) for exclusive worldwide license rights to intellectual property directed to sodium thiosulfate 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 as unforeseen global instability, including political instability, or instability from an outbreak of pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, 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 product will not be as large as expected, the Company’s product 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, 2019. 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.
For further information, please contact:
Investors:
Rosty Raykov
Chief Executive Officer
Fennec Pharmaceuticals Inc.
(919) 636-5144
Media:
Elixir Health Public Relations
Lindsay Rocco
(862) 596-1304