RESEARCH TRIANGLE PARK, N.C., Nov. 10, 2021 (GLOBE NEWSWIRE) — Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARK™ (a unique formulation of sodium thiosulfate) for the prevention of platinum-induced ototoxicity in pediatric patients, today reported its financial results for the third quarter ended September 30, 2021 and provided a business update.
“We continue to work with the FDA on their review of our NDA application, in advance of the pending PEDMARK™ PDUFA target action date of November 27th. We are focused on essential activities in preparation to bring this important treatment to children receiving cisplatin chemotherapy,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals, Inc.
Financial Results for the Third Quarter 2021
- Cash Position – Cash and cash equivalents were $24.3 million as of September 30, 2021. The decrease in cash and cash equivalents between September 30, 2021, and June 30, 2020 is the result of expenses related to the development and preparation of the NDA resubmission of PEDMARK™ and general and administrative expenses. As of September 30, 2021, the Company had $5.0 million in funded debt.
- Research and Development (R&D) Expenses – R&D expenses were $1.2 million for the third quarter ended September 30, 2021 compared to $1.4 million for the same period in 2020. R&D expenses decreased by $0.2 million for the three months ended September 30, 2021 over the same period in 2020 as the Company’s development activities shifted back to essential activities in preparation for the launch of PEDMARK™.
- General and Administrative (G&A) Expenses – G&A expenses decreased by $1.6 million over same period in 2020 due to the timing to NDA approval of the comparative periods. The three months ended September 30, 2020 was the same quarter as the initial NDA approval and the three months ended September 30, 2021 is one quarter prior to our current potential NDA approval. The reduction in general and administrative expenses was slightly offset by higher expenses associated with additional employees and the increase in non-cash equity remuneration expense for employees and board members related to the vesting of new and existing grants.
- Net Loss – Net loss for the quarter ended September 30, 2021 was $4.2 million ($0.16 per share), compared to $6.2 million ($0.24 per share) for the same period in 2020.
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 September 30, 2021 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 | ||||||||
| September 30, | September 30, | |||||||
| 2021 | 2020 | |||||||
| Revenue | $ | — | $ | — | ||||
| Operating expenses: | ||||||||
| Research and development | 1,242 | 1,368 | ||||||
| General and administrative | 2,931 | 4,491 | ||||||
| Loss from operations | (4,173 | ) | (5,859 | ) | ||||
| Other (expense)/income | ||||||||
| Unrealized gain on securities | 39 | — | ||||||
| Amortization expense | (8 | ) | (355 | ) | ||||
| Other loss | (56 | ) | (8 | ) | ||||
| Interest income | 13 | 22 | ||||||
| Total other income, net | (12 | ) | (341 | ) | ||||
| Net (loss) | $ | (4,185 | ) | $ | (6,200 | ) | ||
| Basic net (loss) per common share | $ | (0.16 | ) | $ | (0.24 | ) | ||
| Diluted net (loss) per common share | $ | (0.16 | ) | $ | (0.24 | ) | ||
| Fennec Pharmaceuticals Inc. | ||||||||
| Balance Sheets | ||||||||
| (U.S. Dollars in thousands) | ||||||||
| September 30, 2021 | December 31, | |||||||
| (Unaudited) | 2020 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 24,335 | $ | 30,344 | ||||
| Prepaid expenses | 1,232 | 797 | ||||||
| Other current assets | 412 | 276 | ||||||
| Total current assets | 25,979 | 31,417 | ||||||
| Non-Current assets | ||||||||
| Deferred issuance cost | 508 | 466 | ||||||
| Deferred issuance cost (amortization) | (473 | ) | (466 | ) | ||||
| Total non-current assets | 35 | — | ||||||
| Total assets | $ | 26,014 | $ | 31,417 | ||||
| Liabilities and Shareholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,154 | $ | 1,571 | ||||
| Accrued liabilities | 860 | 776 | ||||||
| Total current liabilities | 2,014 | 2,347 | ||||||
| Long term liabilities | ||||||||
| Term loan | 5,000 | — | ||||||
| Debt discount | (13 | ) | — | |||||
| Total long term liabilities | 4,987 | — | ||||||
| Total liabilities | 7,001 | 2,347 | ||||||
| Shareholders’ equity: | ||||||||
| Common stock, no par value; unlimited shares authorized; 26,010 shares issued and outstanding (2020 -26,003) | 140,780 | 140,733 | ||||||
| Additional paid-in capital | 52,049 | 49,234 | ||||||
| Accumulated deficit | (175,059 | ) | (162,140 | ) | ||||
| Accumulated other comprehensive income | 1,243 | 1,243 | ||||||
| Total shareholders’ equity | 19,013 | 29,070 | ||||||
| Total liabilities and shareholders’ equity | $ | 26,014 | $ | 31,417 | ||||
| Working Capital | ||||||||
| Fiscal Year Ended | ||||||||
| Selected Asset and Liability Data: | September 30, 2021 |
December 31, 2020 |
||||||
| (U.S. Dollars in thousands) | ||||||||
| Cash and cash equivalents | $ | 24,335 | $ | 30,344 | ||||
| Other current assets | 1,644 | 1,073 | ||||||
| Current liabilities | (2,014 | ) | (2,347 | ) | ||||
| Working capital | $ | 23,965 | $ | 29,070 | ||||
| Selected Equity: | ||||||||
| Common stock & APIC | $ | 192,829 | $ | 189,967 | ||||
| Accumulated deficit | (175,059 | ) | (162,140 | ) | ||||
| Stockholders’ equity | 19,013 | 29,070 | ||||||
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 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. 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 November 27, 2021. The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) is currently under evaluation by the European Medicines Agency (EMA).
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
