FENC

MKT CAP $364MP/E —DIV YIELD —FCF YIELD —REV TTM $59.2M +77.8%NET INCOME −$3.3MNET CASH $21.9M52W 5.77 – 12.78SEC XBRL · TTM TO Invalid Date

How FENC rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

Text kept

85%

of sentences unchanged

Added

118

new sentences

Dropped

sentences removed

Length

+1,529

words, now 48,595

New in FY2025

Risks Related to Marketing Approval of Our Product ● PEDMARK ® has received marketing approval from the FDA and from the European Commission, but not from any additional foreign authorities.
Risks Related to Commercialization of Our Product ● Our success depends on our ability to successfully commercialize PEDMARK ® .
If these third parties fail to satisfactorily perform for us, or if they fail to comply with applicable legal and regulatory requirements, it could have a material adverse effect on our business. ● Our strategy depends in part on the efforts of third party development partners to obtain regulatory approvals and commercialize PEDMARK ® outside the United States, including Norgine Pharma UK Limited (“Norgine”) in Europe and Inpharmus (formerly TRPharm İlaç Sanayi Ticaret A.Ş. and TRPharm FZ-LLC) (“Inpharmus”) in Turkey and Gulf Cooperation Council (“GCC”) countries.
Our ability to realize revenues from these territories will depend on the performance of these partners, the timing and outcome of local regulatory submissions, and the pricing and reimbursement decisions in each country.
If our partners do not successfully obtain approvals, secure adequate reimbursement, or effectively commercialize PEDMARK ® in their territories, or if our relationships with them are disrupted, our business, results of operations and prospects could be adversely affected. Risks Related to Government Regulation ● The regulatory approval process is lengthy, and we may not be able to obtain all of the regulatory approvals required to manufacture and commercialize PEDMARK ® in all areas in which we are licensed to supply it. ● We may face significant delays in our clinical studies and trials due to an inability to recruit patients for our clinical studies and trials or to retain patients in the clinical studies and trials we may perform. ● If our third-party suppliers or contract manufacturers do not maintain appropriate standards of manufacturing in accordance with cGMP and other manufacturing regulations, our development and commercialization activities could suffer significant interruptions or delays. ● PEDMARK ® is subject to ongoing regulatory review.
Overview Fennec Pharmaceuticals Inc., a corporation existing under the laws of British Columbia, was originally formed under the name Adherex Technologies Inc. and subsequently changed its name on September 3, 2014.
Fennec is a commercial stage specialty pharmaceutical company dedicated to preventing cisplatin-induced ototoxicity (“CIO”) , a serious and often irreversible side effect of cancer treatment, with one FDA approved and European Commission approved product, PEDMARK ® in the U.S. and PEDMARQSI ® , which is the branded name for PEDMARK ® in Europe, the U.K., Australia and New Zealand (collectively, “PEDMARK”), developed to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month of age and older with localized, non-metastatic solid tumors.
PEDMARK ® is currently the only FDA-approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month of age and older with localized, non-metastatic solid tumors.
In clinical studies in this population, treatment with PEDMARK ® resulted in an approximate 50% relative reduction in the incidence of cisplatin-induced hearing loss compared to cisplatin alone, without evidence of materially compromised antitumor efficacy.
PEDMARK ® is administered as a short intravenous infusion and has generally been associated with a mild-to-moderate and manageable safety profile consistent with its known pharmacology.
In March 2024, we announced that we entered into an agreement with Norgine, a leading European specialist pharmaceutical company.
PEDMARQSI ® is the first and only approved therapy in the EU and U.K. for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients one month to eighteen years of age with localized, non-metastatic solid tumors.
During 2025, Norgine made PEDMARQSI ® commercially available and expects additional launches to occur in 2026 and beyond. Under the terms of the Norgine licensing agreement, Fennec received approximately $43 million in upfront consideration and may receive up to approximately $230 million in additional commercial and regulatory milestone payments and double-digit tiered royalties (up to the mid-twenties) on net sales of PEDMARQSI ® in the licensed territories.
To date, Fennec has not received any milestone payments.
In the United States, we sell our product through an experienced field force including Regional Pediatric Oncology Specialists and we utilize medical science liaisons within our medical team who help educate the medical communities and patients about CIO and our programs supporting patient access to PEDMARK ® .
Additional patents covering PEDMARK ® formulation have been granted in Australia, Canada, the European Patent Office (EPO) (described further below), Hong Kong, Indonesia, Japan, Korea, Malaysia, Mexico, and Russia, and patent applications covering PEDMARK ® are pending in Brazil, China, the European Patent Office (EPO), Hong Kong, Israel, Korea, Mexico, New Zealand, Singapore, and Thailand.
Patents covering alternative sodium thiosulfate formulations have been granted in the United States (US 12,311,026 (the “US ‘026 Patent”), Canada, Korea, Mexico, and Russia, and patent applications covering alternative sodium thiosulfate formulations are pending in the United States, Australia, the EPO, Hong Kong, Indonesia, Japan, Malaysia, Mexico, and New Zealand.
Applications from these patent families, where granted, valid, and enforceable, will expire in July 2039, exclusive of any patent term adjustment or extension There can be no assurance that we do not or will not infringe on patents held by third parties or that third parties in the future will not claim that we have infringed on their patents.
As of January 2025, all medical compendia have incorporated Fennec’s clinical updates, and AHFS, the largest online platform for pharmacists, has updated its content to reflect and differentiate PEDMARK ® in accordance with its labeling. PEDMARK ® is the first and only FDA- and EMA-approved agent designed to reduce the risk of CIO in pediatric patients with localized solid tumors.
Furthermore, digital materials, a digital speaker bureau to engage pediatric oncologists, audiologists, nurses, and pharmacists, along with a patient access services hub and ongoing support from advocacy groups, are all integral components of the strategy. In the U.S. and Europe, Fennec estimates that there are approximately 11,400 pediatric patients with localized, non-metastatic solid tumors each year, of which include approximately 2,157 cisplatin-treated pediatric patients in the U.S. and 1,250 in Europe who fall within the current PEDMARK ® market.
The incidence and severity of CIO depends on the cumulative dose and duration of chemotherapy.
Many affected children ultimately require hearing aids or, in more severe cases, cochlear implants, which are costly, technically complex and do not fully restore normal hearing.
PEDMARK ® is the first and only therapy approved in the U.S. to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month of age and older with localized, non-metastatic solid tumors.
Infants and young children who experience ototoxicity during critical developmental windows are at risk for impaired speech and language development and literacy, while older children and adolescents may face long-term challenges in academic performance, social-emotional development, career potential and independent living. In the U.S., approximately 90% of pediatric cancer patients receive care at approximately 200 key pediatric hospital centers, including institutions within the Children’s Oncology Group (COG), National Cancer Institute (NCI) and National Comprehensive Cancer Network (NCCN). The Adolescent and Young Adult (“AYA”) oncology patient is defined as an individual between 15 and 39 years of age at the time of initial cancer diagnosis.
In the U.S., Fennec estimates that there are approximately 51,282 new AYA solid tumor cases annually, of which approximately 20,858 involve cisplatin-treated patients with localized, non-metastatic solid tumors.
The most common relevant tumor types include germ cell tumors, testicular cancer, thyroid cancer and breast cancer.
AYA oncology treatment landscape spans both academic and community settings, with 72 NCI-designated academic centers treating roughly 20% of AYA oncology patients, while approximately 80% are managed across approximately 3,750 community oncology centers nationwide.
CIO and Unmet Medical Need Cisplatin is a cornerstone of modern cancer therapy for many pediatric and AYA solid tumors, with reported overall survival rates in some cisplatin-treated cancers exceeding 80%.
However, cisplatin is associated with a high incidence of ototoxicity.
Published data indicates that approximately 60% to 90% of cisplatin-treated patients may develop some degree of permanent, sensorineural hearing loss, with reported rates of 40% to 80% occurring in adults and 50% to 90% in children.
CIO typically begins as bilateral, high-frequency hearing loss that is progressive and irreversible, occasionally accompanied by tinnitus.
In some cases, it may ultimately require the use of hearing aids or cochlear implants.
Published literature has linked treatment-related hearing loss to impairments in speech and language development, reduced academic performance, challenges in social-emotional development, and enduring impacts on educational attainment, vocational opportunities, and independent living.
Additionally, published research indicates that severe to profound early-onset hearing loss can impose a substantial lifetime economic burden, with per-individual costs estimated at approximately $489 and potentially exceeding $1,000 on an undiscounted basis, primarily due to lost productivity, educational expenses, and medical costs.
These figures are derived from published literature regarding the disease burden of hearing loss and do not represent demonstrated health-economic outcomes specifically attributable to PEDMARK.
In December 2024, PEDMARQSI ® received positive final draft guidance from the National Institute for Health and Care Excellence (NICE).
Most recently, in 2025, Norgine launched PEDMARQSI ® in Germany and the U.K with additional countries within the EU expected in 2026. Distribution Agreement – Turkey and the Gulf Cooperation Council In 2025, we entered into a distribution agreement with Inpharmus for the commercialization of PEDMARK ® in Turkey and the GCC countries.
Under this agreement, Inpharmus will be responsible for certain regulatory, commercialization and distribution activities in the covered territories, and we will supply PEDMARK ® and receive payments, subject to specified terms and conditions.
Commercialization in these markets is subject to obtaining and maintaining necessary regulatory approvals and reimbursement, and there can be no assurance as to the timing or magnitude of future revenues, if any, from these territories. Japan: STS-J01 Investigator-Initiated Trial and Registration Plans In Japan, an independent investigator-initiated clinical trial, known as STS-J01, has been evaluating PEDMARK ® for the prevention of CIO.
In December 2025, we announced positive topline results from this trial that demonstrated use of PEDMARK ® was associated with a significant reduction in the incidence of hearing loss compared to historically reported rates in patients receiving cisplatin alone, with no evidence of reduced antitumor activity and an approximate 95% clinical response rate.

and 78 more.

Gone since FY2024

Risks Related to Marketing Approval of Our Product Candidate ● PEDMARK ® has received marketing approval from the FDA and from the European Commission, but not from any additional foreign authorities.
Risks Related to Commercialization of Our Product Candidate ● Our success depends on our ability to successfully commercialize PEDMARK ® .
If these third parties fail to satisfactorily perform for us, or if they fail to comply with applicable legal and regulatory requirements, it could have a material adverse effect on our business.
Risks Related to Government Regulation ● The regulatory approval process is lengthy, and we may not be able to obtain all of the regulatory approvals required to manufacture and commercialize PEDMARK ® in all areas in which we are licensed to supply it. ● We may face significant delays in our clinical studies and trials due to an inability to recruit patients for our clinical studies and trials or to retain patients in the clinical studies and trials we may perform. ● If our third-party suppliers or contract manufacturers do not maintain appropriate standards of manufacturing in accordance with cGMP and other manufacturing regulations, our development and commercialization activities could suffer significant interruptions or delays. ● PEDMARK ® is subject to ongoing regulatory review.
Business Overview Fennec Pharmaceuticals Inc., a corporation existing under the laws of British Columbia, was originally formed under the name Adherex Technologies Inc. and subsequently changed its name on September 3, 2014.
Fennec is a commercial stage specialty pharmaceutical company with one FDA approved and European Commission approved product, PEDMARK ® in the U.S. and PEDMARQSI ® , which is the branded name for PEDMARK ® outside of the U.S.
(collectively, “PEDMARK”), developed to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month of age and older with localized, non-metastatic solid tumors.
In March 2024, we announced that we entered into an agreement with Norgine Pharma UK Limited (“Norgine”), a leading European specialist pharmaceutical company.
PEDMARQSI ® is the first and only approved therapy in the EU and U.K. for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localized, non-metastatic solid tumors. Under the terms of the Norgine licensing agreement, Fennec received approximately $43 million in upfront consideration and may receive up to approximately $230 million in additional commercial and regulatory milestone payments and double-digit tiered royalties (up to the mid-twenties) on net sales of PEDMARQSI ® in the licensed territories.
In the United States, we sell our product through an experienced field force including Regional Pediatric Oncology Specialists and medical science liaisons who are helping to educate the medical communities and patients about cisplatin induced ototoxicity and our programs supporting patient access to PEDMARK ® .
We are also pursuing additional patent applications in both the U.S. and internationally for PEDMARK ® . There can be no assurance that we do not or will not infringe on patents held by third parties or that third parties in the future will not claim that we have infringed on their patents.
As of January 2025, all medical compendia have incorporated Fennec’s clinical updates, and AHFS, the largest online platform for pharmacists, has updated its content to reflect and differentiate PEDMARK ® in accordance with its labeling. PEDMARK ® is the first and only FDA- and EMA-approved agent designed to reduce the risk of cisplatin-induced hearing loss (CIO) in children with localized solid tumors.
Furthermore, digital materials, a digital speaker bureau to engage pediatric oncologists, audiologists, nurses, and pharmacists, along with a patient access services hub and ongoing support from advocacy groups, are all integral components of the strategy. In the U.S. and Europe, it is estimated that more than 10,000 pediatric may receive platinum-based chemotherapy on an annual basis.
The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids.
PEDMARK® is the first and only therapy approved to mitigate the risk of ototoxicity associated with cisplatin, a form of platinum based chemotherapy, in pediatric patients aged one month and older with localized, non-metastatic solid tumors.
Beyond the use of PEDMARK, 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.
The U.S. pediatric oncology landscape includes approximately 200 targeted pediatric hospital centers, such as those within the Children's Oncology Group (COG), National Cancer Institute (NCI), and National Comprehensive Cancer Network (NCCN) institutions.
Around 80% of pediatric cancer patients receive treatment at these key centers. The Adolescent and Young Adult (AYA) oncology patient is defined as an individual between the ages of 15 and 39 at the time of initial cancer diagnosis.
In the U.S., Fennec estimates that approximately 20,000 cisplatin chemotherapy patients are treated annually with the primary tumor types of thyroid cancer, breast cancer, germ cell cancer and testicular cancer.
Adolescent and Young Adult (AYA) oncology landscape is shaped by a combination of academic and community centers across the nation.
Academic institutions play a critical role in establishing the treatment framework, with 72 NCI-designated academic centers treating approximately 20% of AYA oncology patients.
In contrast, around 80% of patients are treated at 3,750 community centers throughout the country. Cisplatin Induced Ototoxicity (“CIO”) Cisplatin and other platinum compounds are essential chemotherapeutic agents for the treatment of many pediatric and adult malignancies.
Unfortunately, platinum-based therapies can cause ototoxicity, or hearing loss, which is permanent, irreversible, and particularly harmful to the survivors of pediatric cancer.
The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these patients require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.
Infants and young children that are affected by ototoxicity at critical stages of development lack speech and language development and literacy, and older children and adolescents often lack social-emotional development and educational achievement.
It is estimated that greater than 50% of pediatric patients may suffer permanent hearing loss as a result of CIO and approximately 40-80% of adult patients may suffer permanent hearing loss as a result of CIO.
Most recently, in December 2024, PEDMARQSI received positive final draft guidance from the National Institute for Health and Care Excellence (NICE).
Further, in February 2025, Norgine announced the launch of PEDMARQSI in Germany. Third-Party Reimbursement Sales of drug products depend in significant part on the availability of coverage and adequate reimbursement by third party payors, such as state and federal governments, including Medicare and Medicaid, managed care providers, private commercial insurance plans and pharmacy benefit management (PBM) plans.
We are also pursuing additional patent applications in both the U.S. and internationally for PEDMARK ® .
Additional applications from these patents are pending in Australia, Brazil, Canada, China, the European Patent Office (EPO), Hong Kong, Israel, Japan, South Korea, Mexico, Malaysia, New Zealand, Russia, Singapore, and Thailand.
Applications from these patent families, where granted, valid, and enforceable, will expire in July 2039, exclusive of any patent term adjustment or extension.
We have exclusively in-licensed from Oregon Health & Science University (“OHSU”) one patent family directed to the use of sodium thiosulfate to reduce the occurrence of ototoxicity.
This family includes the granted US ‘190 Patent and two pending US patent application.
The US ‘190 Patent had been listed in the FDA Orange Book.
On April 18, 2023, the PTAB invalidated the only claim of the‘190 Patent.
In light of PTAB’s final written decision on the invalidity of the ‘190 Patent, we requested that the FDA remove the ’190 Patent from the Orange Book.
Two United States patent applications claiming priority through the ‘190 Patent remain pending at the United States Patent and Trademark Office (“USPTO”).
On November 5, 2024, the European Patent Office notified Fennec of its intent to grant European Patent Application No 19830950.2, which covers the pharmaceutical formulation of PEDMARQSI ® (EU Brand name for PEDMARK ® ) .
This patent, when granted, will expire in July 2039, unless held invalid or unenforceable by a court of final jurisdiction.

and 57 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

Watch FENC. Know when insiders buy.

One email the day a filing lands. Free.