Fennec Pharmaceuticals Announces First Quarter 2022 Financial Results and Provides Business Update
12 Mai 2022 - 12:00PM
Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty
pharmaceutical company focused on the development of
PEDMARKTM (a unique formulation of sodium thiosulfate (STS))
for the prevention of platinum-induced ototoxicity in pediatric
patients, today reported its financial results for the fiscal
quarter ended March 31, 2022 and provided a business update.
“We are pleased that the FDA has accepted our
resubmission of the NDA for PEDMARK™,” said Rosty Raykov, chief
executive officer of Fennec Pharmaceuticals. “While we are working
closely with the FDA to facilitate their review of our NDA, we
continued to execute against key initiatives across our commercial,
clinical, and manufacturing operations. Our commercial team is
actively preparing for launch readiness as we await a decision from
the FDA by the September 23, 2022 PDUFA target action date.”
Upcoming Investor Event
- Annual Meeting of
Shareholders – Fennec would like to invite shareholders to
attend its Annual General Meeting on Tuesday, June 14,
2022 at 11:00 a.m. ET, which will be held in person at
The Fifty Sonesta Select Hotel, The Den Room, 155 East 50th Street
at Third Avenue, New York, NY 10022, USA, or online by visiting
www.virtualshareholdermeeting.com/FENC2022.
Financial Results for the First Quarter
2022
- Cash Position –
Cash and cash equivalents were $18.3 million as of March 31, 2022.
The decrease in cash and cash equivalents between March 31, 2022
and December 31, 2021, is the result of expenses related to the
development and preparation of our New Drug Application (NDA)
resubmission of PEDMARK™ and general and administrative
expenses.
- Research and Development
(R&D) Expenses – R&D expenses were $1.4 million
for the first quarter ended March 31, 2022 compared to $2.4 million
for the same period in 2021. R&D expenses decreased by $1.0
million for the three months ended March 31, 2022 over the same
period in 2021 as the Company’s development activities decreased
Company’s as efforts on year over year basis were less focused on
development and shifted towards pre commercialization
activities.
- General and Administrative
(G&A) Expenses – G&A expenses were $2.1 million
for the first quarter ended March 31, 2022, compared to $2.5
million for the same period in 2021. The decrease in general
and administrative expenses over same period in 2021 reflects
select expenses associated with pre-commercialization not needing
to be repeated as they were completed in 2021.
- Net Loss – Net
loss for the quarter ended March 31, 2022 was $3.7 million ($0.14
per share), compared to $4.7million ($0.18 per share) for the same
period in 2021.
Financial Update
The selected financial data presented below is
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 March 31,
2022 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 |
|
|
March 31, |
|
|
March 31, |
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
|
Revenue |
|
$ |
- |
|
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
|
1,437 |
|
|
|
|
2,416 |
|
General and administrative |
|
|
2,109 |
|
|
|
|
2,507 |
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(3,546 |
) |
|
|
|
(4,923 |
) |
|
|
|
|
|
|
|
|
Other
(expense)/income |
|
|
|
|
|
|
|
Unrealized (loss)/gain on
securities |
|
|
(91 |
) |
|
|
|
182 |
|
Amortization expense |
|
|
(7 |
) |
|
|
|
- |
|
Interest expense and other |
|
|
(61 |
) |
|
|
|
(8 |
) |
Net interest income |
|
|
9 |
|
|
|
|
16 |
|
Total other (expense)/income, net |
|
|
(150 |
) |
|
|
|
190 |
|
|
|
|
|
|
|
|
|
Net
(loss) |
|
$ |
(3,696 |
) |
|
|
$ |
(4,733 |
) |
|
|
|
|
|
|
|
|
Basic net (loss) per
common share |
|
$ |
(0.14 |
) |
|
|
$ |
(0.18 |
) |
|
|
|
|
|
|
|
|
Diluted net (loss) per
common share |
|
$ |
(0.14 |
) |
|
|
$ |
(0.18 |
) |
|
|
|
|
|
|
|
|
Fennec Pharmaceuticals Inc. |
Balance Sheets |
(U.S. Dollars in thousands) |
|
|
|
UnauditedMarch 31, 2022 |
|
|
AuditedDecember 31, 2021 |
Assets |
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
18,259 |
|
|
$ |
21,100 |
Other current assets |
|
|
869 |
|
|
|
1,287 |
Non-current assets, net |
|
|
21 |
|
|
|
27 |
Total assets |
|
$ |
19,149 |
|
|
$ |
22,414 |
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
Current liabilities |
|
$ |
2,136 |
|
|
$ |
1,654 |
Non-current liabilities, net |
|
|
4,489 |
|
|
|
4,988 |
Total stockholders’ equity |
|
|
12,524 |
|
|
|
15,772 |
Total liabilities and stockholders’ equity |
|
$ |
19,149 |
|
|
$ |
22,414 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Working Capital |
|
Fiscal Year Ended |
Selected Asset and Liability Data: |
|
March 31, 2022 |
|
|
December 31, 2021 |
(U.S. Dollars in thousands) |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
18,259 |
|
|
|
$ |
21,100 |
|
Other current assets |
|
|
869 |
|
|
|
|
1,287 |
|
Current liabilities |
|
|
(2,136 |
) |
|
|
|
(1,654 |
) |
Working capital |
|
$ |
16,992 |
|
|
|
$ |
20,733 |
|
|
|
|
|
|
|
|
|
Selected Equity: |
|
|
|
|
|
|
|
Common stock & APIC |
|
$ |
194,463 |
|
|
|
$ |
194,015 |
|
Accumulated deficit |
|
|
(183,182 |
) |
|
|
|
(179,486 |
) |
Stockholders’ equity |
|
|
12,524 |
|
|
|
|
15,772 |
|
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 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. 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 Securities and Exchange
Commission including its Annual Report on Form 10-K for the
year ended December 31, 2021. 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:Robert AndradeChief
Financial OfficerFennec Pharmaceuticals Inc.(919) 246-5299
Media:Elixir Health Public RelationsLindsay
Rocco(862) 596-1304lrocco@elixirhealthpr.com
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