Fennec Pharmaceuticals Announces Third Quarter 2020 Financial Results and Provides Business Update
November 16 2020 - 7:01AM
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, 2020 and provided a business update.
“We are pleased with the recent constructive and
collaborative Type A meeting with the FDA to discuss the path
forward for resubmission of the New Drug Application (NDA) for
PEDMARK™ for the prevention of life-long hearing loss for
children receiving cisplatin chemotherapy,” said Rosty Raykov,
chief executive officer of Fennec Pharmaceuticals. “Importantly,
there were no clinical or safety issues identified in the complete
response letter (CRL) and there are no requirements for additional
clinical data within the CRL. We are working closely with the FDA
and our third-party drug product manufacturer to fully address the
CRL and plan to resubmit the NDA for PEDMARK™ with the goal of
achieving regulatory approval and making PEDMARK™ commercially
available to patients in need as quickly as possible.”
Financial Results for
the Third Quarter
2020
- Cash Position
– Cash and cash equivalents were $33.2 million as
of September 30, 2020. The reduction in cash balance is the result
of cash used for operating activities including regulatory
activities of PEDMARK™ and expenses associated with commercial
and operational launch preparation during the quarter. As of
September 30, 2020, the Company has no funded debt.
- Research
and Development
(R&D) Expenses – R&D expenses
were $1.4 million for the third quarter ended September 30, 2020,
compared to $0.8 million for the same period in 2019. The increase
in R&D in the quarter was due to an increase in R&D
expenses after the Complete Response Letter (CRL).
-
General and
Administrative
(G&A) Expenses
– G&A expenses for the third quarter ended
September 30, 2020, increased by $3.4 million over the same period
in 2019, reflecting the Company’s focus on commercialization
readiness of PEDMARK™. The increase in G&A during the quarter
was primarily due to commercialization readiness activities during
the quarter leading up to the PDUFA date of PEDMARK in August
2020.
- Net Loss
– Net loss for the quarter ended September 30,
2020 was $6.2 million ($0.24 per share), compared to $1.8 million
($0.09 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 September
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 ConsolidatedStatements of
Operations:(U.S. Dollars in thousands except per share amounts)
|
Three Months Ended |
|
|
September 30, |
|
|
September
30, |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
Revenue |
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
1,368 |
|
|
|
795 |
|
General and administrative |
|
4,491 |
|
|
|
1,068 |
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(5,859 |
) |
|
|
(1,863 |
) |
|
|
|
|
|
|
|
|
Other
(expense)/income |
|
|
|
|
|
|
|
Amortization expense |
|
(355 |
) |
|
|
(17 |
) |
Other loss |
|
(8 |
) |
|
|
1 |
|
Net interest income |
|
22 |
|
|
|
70 |
|
Total other income, net |
|
(341 |
) |
|
|
54 |
|
|
|
|
|
|
|
|
|
Net
(loss) |
$ |
(6,200 |
) |
|
$ |
(1,809 |
) |
|
|
|
|
|
|
|
|
Basic net (loss) per
common share |
$ |
(0.24 |
) |
|
$ |
(0.09 |
) |
|
|
|
|
|
|
|
|
Diluted net (loss) per
common share |
$ |
(0.24 |
) |
|
$ |
(0.09 |
) |
Fennec Pharmaceuticals Inc. |
Balance Sheets |
(U.S. Dollars in thousands) |
|
|
|
Unaudited September 30, 2020 |
|
|
Audited December 31, 2019 |
Assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
33,166 |
|
$ |
13,650 |
Other current assets |
|
904 |
|
|
234 |
Non-current assets, net |
|
- |
|
|
262 |
Total Assets |
$ |
34,070 |
|
$ |
14,146 |
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
Current liabilities |
$ |
2,885 |
|
$ |
2,271 |
Total stockholders’ equity |
|
31,185 |
|
|
11,875 |
Total liabilities and stockholders’ equity |
$ |
34,070 |
|
$ |
14,146 |
|
|
|
|
|
|
Working Capital |
|
Fiscal Year Ended |
|
Selected Asset and Liability Data: |
|
September 30, 2020 |
|
|
December 31, 2019 |
|
(U.S. Dollars in thousands) |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
33,166 |
|
|
$ |
13,650 |
|
Other current assets |
|
|
904 |
|
|
|
234 |
|
Current liabilities |
|
|
(2,885 |
) |
|
|
(2,271 |
) |
Working capital |
|
$ |
31,185 |
|
|
$ |
11,613 |
|
|
|
|
|
|
|
|
|
|
Selected Equity: |
|
|
|
|
|
|
|
|
Common stock & APIC |
|
$ |
188,844 |
|
|
$ |
154,663 |
|
Accumulated deficit |
|
|
(158,902 |
) |
|
|
(144,031 |
) |
Stockholders’ equity |
|
|
31,185 |
|
|
|
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 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.
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. These
forward-looking statements include the Company’s expectations
regarding its interactions and communications with the FDA,
including its expectation to discuss with the FDA the issues raised
in the CRL and the Company’s plans to address them.
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 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, Fennec’s reliance on third party manufacturing,
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, 2019 and its Quarterly Report on
Form 10-Q for the quarter ended September 30, 2020. Fennec
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 RaykovChief Executive
OfficerFennec Pharmaceuticals Inc.(919) 636-5144
Media:Elixir Health Public RelationsLindsay
Rocco(862) 596-1304lrocco@elixirhealthpr.com
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