Fennec Pharmaceuticals Announces First Quarter 2021 Financial Results and Provides Business Update
~ Fennec Remains on Track to Finalize and Resubmit the New Drug Application for PEDMARK™ to the
~ Company Has Approximately
“We remain on track to finalize and resubmit the New Drug Application for PEDMARKTM to the
Upcoming Investor Event
- Annual Meeting of Shareholders – Fennec would like to invite shareholders to attend its Annual General Meeting on Tuesday, June 29, 2021 at 1:00 p.m. ET, which will be held online by visiting www.virtualshareholdermeeting.com/FENC2021.
Financial Results for the First Quarter 2021
- Cash Position – Cash and cash equivalents were
$26.7 millionas of March 31, 2021. The decrease in cash and cash equivalents between March 31, 2021and December 31, 2020, is the result of expenses related to the development and preparation of our New Drug Application (NDA) resubmission of PEDMARKTM and general and administrative expenses. The Company has no outstanding debt.
- Research and Development (R&D) Expenses – R&D expenses were
$2.4 millionfor the first quarter ended March 31, 2021compared to $1.4 millionfor the same period in 2020. R&D expenses increased by $1.0 millionfor the three months ended March 31, 2021over the same period in 2020 as the Company’s development activities increased in preparation for the NDA resubmission.
- General and Administrative (G&A) Expenses – G&A expenses were
$2.5 millionfor the first quarter ended March 31, 2021, compared to $2.4 millionfor the same period in 2020.
- Net Loss – Net loss for the quarter ended
March 31, 2021was $4.7 million( $0.18per share), compared to $3.8 million( $0.19per share) for the same period in 2020.
The selected financial data presented below is derived from our unaudited condensed consolidated financial statements, which were prepared in accordance with
Unaudited Condensed Consolidated
Statements of Operations:
|Three Months Ended|
|Research and development||2,416||1,393|
|General and administrative||2,507||2,442|
|Loss from operations||(4,923||)||(3,835||)|
|Unrealized gain on securities||182||-|
|Net interest income||16||35|
|Total other income, net||190||9|
|Basic net (loss) per common share||$||(0.18||)||$||(0.19||)|
|Diluted net (loss) per common share||$||(0.18||)||$||(0.19||)|
|Cash and cash equivalents||$||26,751||$||30,344|
|Other current assets||455||276|
|Liabilities and stockholders’ equity|
|Total stockholders’ equity||24,933||29,070|
|Total liabilities and stockholders’ equity||$||27,825||$||31,417|
|Working Capital||Fiscal Year Ended|
|Selected Asset and Liability Data:||
|Cash and cash equivalents||$||26,751||$||30,344|
|Other current assets||1,074||1,073|
|Common stock & APIC||$||190,563||$||189,967|
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.
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 Marketing Authorization Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) 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.
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 resolution the issues raised in the CRL and the Company’s plans to address them, and the anticipated timing of the Company’s finalization and filing of an NDA resubmission for 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 such risks and uncertainties relating to the Company’s reliance on third party manufacturing, the risk that unforeseen factors may delay the resubmission of the NDA, the risks of delays in or failure to obtain FDA approval of PEDMARK, the risks relating to the Company’s and its manufacturer’s ability to adequately address the concerns identified in the CRL, the risk that the resubmission of the NDA 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 Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2020. Fennec disclaims any obligation to update these forward-looking statements except as required by law.
For further information, please contact:
Chief Financial Officer
Elixir Health Public Relations
Source: Fennec Pharmaceuticals Inc.