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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K/A
(Amendment No. 1)
Current Report
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
February 29, 2024
FENNEC PHARMACEUTICALS
INC.
(Exact name of registrant as specified in its charter)
001-32295
(Commission File Number)
British Columbia, Canada |
|
20-0442384 |
(State or other jurisdiction of
incorporation) |
|
(I.R.S. Employer Identification
No.) |
PO Box 13628, 68 TW Alexander Drive,
Research Triangle Park, NC |
|
27709 |
(Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number, including
area code: (919) 636-4530
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading symbol(s) |
Name of each exchange on which
registered |
Common shares, no par value |
FENC |
Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ¨
Background.
This Amendment No. 1 to the Current Report on
Form 8-K/A hereby amends and restates the Current Report on Form 8-K as filed with the Securities and Exchange Commission on February
29, 2024 to properly disclose the results of operations and financial condition of Fennec Pharmaceuticals Inc. (“Fennec” or
the “Company”) under Item 2.02.
Item 2.02 |
Results of Operations and Financial Condition. |
On February 29, 2024, Fennec issued a press release
announcing financial results for the fourth quarter and full-year ended December 31, 2023. A copy of the Press Release is attached hereto
as Exhibit 99.1 and is hereby incorporated by reference in this Item 2.02. The press release did not include certain financial statements,
related footnotes and certain other financial information that will be filed with the Securities and Exchange Commission as part of the
Company’s Annual Report on Form 10-K.
The information and exhibit contained in this
Item 2.02 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of
1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except
as shall be expressly set forth by specific reference in such filing.
Item 9.01 |
Financial Statements and Exhibits. |
SIGNATURE
Pursuant to the requirements of the Securities
Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: March 6, 2024 |
FENNEC PHARMACEUTICALS INC. |
|
|
|
|
By: |
/s/ Rostislav Raykov |
|
|
Rostislav Raykov |
|
|
Chief Executive Officer |
Exhibit 99.1
Fennec
Pharmaceuticals Reports Preliminary Unaudited Net Revenue for Fourth Quarter and Full-Year 2023 Results
~ Fourth Quarter 2023 Net Revenues of Approximately
$9.2 to $9.7 Million ~
~ Company
Expects to Report 2023 Fourth Quarter and Audited Full-Year Results on or about March 26, 2024 ~
RESEARCH
TRIANGLE PARK, N.C., February 29, 2024
– Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced
preliminary unaudited fourth quarter and full-year 2023 net revenues.
The information
in this press release is based upon preliminary unaudited information and management estimates for the fourth quarter 2023 and is subject
to the completion of Fennec’s financial closing procedures and year end audit.
Preliminary Unaudited 2023 Fourth Quarter
Revenue and Year End Performance:
| • | Fourth quarter 2023 net revenues are expected to be approximately $9.2 to
$9.7 million, which represents approximately a 41-49% increase over the third quarter of 2023. |
| • | Full-year 2023 net revenues are expected to be approximately $20.7 to $21.2
million. |
Fennec expects
to report its 2023 fourth quarter and audited full-year year results of operations on or about March 26, 2024.
PEDMARK® (sodium thiosulfate
injection)
PEDMARK®
is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated
with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate
in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is also the only therapeutic agent with proven efficacy
and safety data with an established dosing paradigm, across two open-label, randomized Phase 3 clinical studies, the Clinical Oncology
Group (COG) Protocol ACCL0431 and SIOPEL 6.
In the U.S.
and Europe, it is estimated that, annually, more than 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 co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG 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, medulloblastoma,
and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.
About Fennec Pharmaceuticals
Fennec
Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development and commercialization of PEDMARK® and
PedmarqsiTM to reduce the risk of platinum-induced ototoxicity in pediatric patients. Further, PEDMARK received FDA approval
in September 2022 and European Commission Marketing Authorization in June 2023 for Pedmarqsi. PEDMARK has
received Orphan Drug Exclusivity in the U.S. for seven years of market protection and Pedmarqsi has received Pediatric Use
Marketing Authorization in Europe which includes eight years plus two years of data and market protection. 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 reduction of risk 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 statements about
our business strategy, timeline, and other goals, plans and prospects, including our commercialization plans respecting PEDMARK®,
the market opportunity for and market impact of PEDMARK®, its potential impact on patients and anticipated benefits associated
with its use, and potential access to further funding after the date of this release. 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 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, 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, our ability to obtain necessary capital when needed on acceptable
terms or at all, 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, 2022. 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 Andrade
Chief Financial Officer
Fennec Pharmaceuticals Inc.
(919) 246-5299
Media:
Elixir Health Public Relations
Lindsay Rocco
(862) 596-1304
lrocco@elixirhealthpr.com
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Fennec Pharmaceuticals (NASDAQ:FENC)
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Fennec Pharmaceuticals (NASDAQ:FENC)
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