Fennec Pharmaceuticals Announces Third Quarter 2021 Financial Results and Provides Business Update
~ FDA Prescription Drug User Fee Act (PDUFA) Target Action Date Set for
~ If Approved by the FDA, PEDMARK™ Stands to Be the First Therapy for the Prevention of Cisplatin-Induced Hearing Loss in Children ~
~ Company Has Approximately
“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
Financial Results for the Third Quarter 2021
- Cash Position – Cash and cash equivalents were
$24.3 million as ofSeptember 30, 2021 . The decrease in cash and cash equivalents betweenSeptember 30, 2021 , andJune 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 ofSeptember 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 endedSeptember 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 endedSeptember 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 endedSeptember 30, 2020 was the same quarter as the initial NDA approval and the three months endedSeptember 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
| Unaudited Condensed Consolidated | ||||||||
| Statements of Operations: | ||||||||
| ( |
||||||||
| Three Months Ended | ||||||||
| 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 | ) | ||
| Balance Sheets | ||||||||
| ( |
||||||||
| (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: | 2021 |
2020 |
||||||
| ( |
||||||||
| 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
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
Forward Looking Statements
Except for historical information described in this press release, all other statements are forward-looking. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include the Company’s expectations regarding its interactions and communications with the FDA, including the Company’s expectations and goals respecting the NDA resubmission for PEDMARK™. Obtaining Fast Track Designation and Breakthrough Therapy Designation by the FDA is no guarantee that the FDA will approve the NDA resubmission of PEDMARK. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including the risk that unforeseen factors may result in delays in or failure to obtain FDA approval of PEDMARK, the risks and uncertainties relating to the Company’s reliance on third party manufacturing, the risks that the Company’s NDA resubmission does not adequately address the concerns identified in the CRL previously provided by the FDA, the risk that the NDA resubmission to the FDA will not be satisfactory, that regulatory and guideline developments may change, scientific data and/or manufacturing capabilities 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, 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, 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
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:
Chief Financial Officer
(919) 246-5299
Media:
Elixir Health Public Relations
(862) 596-1304
lrocco@elixirhealthpr.com
Source: Fennec Pharmaceuticals Inc.