Fennec Pharmaceuticals Presents Real World Data Supporting the Integration and Clinical Use of PEDMARK® in Treating Adults with Head & Neck Cancers

Rhea-AI Summary

Fennec Pharmaceuticals (NASDAQ:FENC) presented multi-institutional real-world data on PEDMARK® for adults with head & neck cancers at MHNCS, Feb 19–21, 2026. A retrospective review of 15 adults found PEDMARK® given ≥6 hours after cisplatin was safely integrated into care with no disruption to curative-intent cisplatin delivery.

Most high-risk patients showed no measurable hearing loss during or after treatment, PEDMARK® had only isolated, self-limited infusion events and no grade 3–4 toxicities, supporting further exploration in head & neck cancer populations.

Positive

• Timing adherence: PEDMARK® safely administered ≥6 hours post-cisplatin
• Majority of high-risk patients experienced no measurable hearing loss
• Safety profile: no grade 3–4 toxicities and only isolated infusion events
• Operational feasibility: PEDMARK® was easily integrated into real-world care pathways

Negative

• Small sample size: 15 patients limits statistical strength
• Retrospective design: no randomized control to confirm causality
• Findings are early signals and require further prospective study for confirmation

Key Figures

Sample size: 15 adults Post-cisplatin timing: ≥6 hours Toxicity grades: No grade 3 or 4 toxicities +2 more

5 metrics

Sample size 15 adults Multi-institutional retrospective review in head and neck cancers

Post-cisplatin timing ≥6 hours PEDMARK administration window after cisplatin dosing

Toxicity grades No grade 3 or 4 toxicities Safety profile of PEDMARK in adult HNC cohort

Pediatric indication ≥1 month of age Approved PEDMARK use in pediatric localized non-metastatic solid tumors

NCCN recommendation 2A NCCN category for adolescent and young adult PEDMARK use

Market Reality Check

Price: $8.78 Vol: Volume 72,607 vs 20-day a...

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$8.78 Last Close

Volume Volume 72,607 vs 20-day average 107,723, indicating below-average trading activity ahead of this update. low

Technical Price $8.78 is trading above the 200-day MA at $8.17, showing a pre-existing upward trend into this news.

Peers on Argus

Among tracked peers, CADL was down 12.09999993443489% while VNDA was up 1.970000...

1 Up 1 Down

Among tracked peers, CADL was down 12.09999993443489% while VNDA was up 1.970000006258488%, pointing to mixed sector action and suggesting this headline is more stock-specific than part of a broad biotech move.

Historical Context

5 past events · Latest: Dec 26 (Negative)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 26	Shareholder stake cut	Negative	-4.9%	Large holder Southpoint sold 1,000,000 shares at $7.50 per share.
Dec 09	New trial announcement	Positive	+1.3%	City of Hope to run Phase I trial of PEDMARK in metastatic testicular cancer.
Dec 02	Clinical data update	Positive	-1.6%	Positive Phase 2/3 PEDMARK data in Japan reducing cisplatin-induced hearing loss.
Nov 26	Conference participation	Neutral	-0.8%	Participation in Piper Sandler healthcare conference via fireside chat webcast.
Nov 19	Debt redemption	Positive	-6.5%	Repurchased all Petrichor convertible notes, leaving company with no outstanding debt.

Pattern Detected

Positive corporate or clinical developments have sometimes seen mixed or even negative next-day price reactions.

Recent Company History

Recent news shows Fennec balancing clinical expansion and capital structure moves. On Nov 19, 2025, it completed a full debt redemption totaling $21,729,455.30, leaving no outstanding debt, yet shares fell. Positive topline PEDMARK® data from Japan on Dec 2, 2025 and an investigator‑sponsored trial announcement on Dec 9, 2025 produced modest and mixed reactions. A large shareholder sale on Dec 24, 2025 coincided with a larger decline. Today’s real‑world HNC data extends the strategy of broadening PEDMARK® use beyond pediatrics.

Market Pulse Summary

This announcement highlights real‑world feasibility data for PEDMARK® in 15 adults with head and nec...

Analysis

This announcement highlights real‑world feasibility data for PEDMARK® in 15 adults with head and neck cancer, using dosing ≥6 hours after cisplatin and reporting no grade 3 or 4 toxicities. It builds on prior PEDMARK® clinical results and its existing pediatric approval with an NCCN 2A recommendation. Investors may watch for larger adult studies, additional tumor types, and further adoption data to gauge how these signals translate into broader clinical use and long‑term value.

Key Terms

cisplatin, national comprehensive cancer network

2 terms

cisplatin medical

"PEDMARK® could be safely given ≥six hours after cisplatin dosing"

Cisplatin is a widely used chemotherapy drug containing platinum that kills cancer cells by binding to their DNA and preventing the cells from copying and repairing themselves. Investors pay attention to cisplatin because its patent status, clinical use, side effects, manufacturing costs and inclusion in treatment guidelines influence demand, sales and liability risk for drug makers and hospitals — think of it as a powerful tool whose availability and reputation can shift a company's revenue like a key product line.

national comprehensive cancer network regulatory

"recognized by the National Comprehensive Cancer Network with a 2A recommendation"

A coalition of major cancer centers and experts that develops widely used, evidence-based treatment guidelines for oncology care. Its recommendations act like a trusted rulebook or roadmap for doctors, insurers and hospitals, so updates can change which therapies get prescribed, reimbursed or adopted—making it an important influence on drug uptake, clinical trial value and healthcare company prospects.

AI-generated analysis. Not financial advice.

– Administration of PEDMARK^® Approximately Six Hours After Cisplatin was Shown to Be Safe & Easily Integrated into Care for Adults with Head & Neck Cancers (HNC) –

– Early Signals of Hearing Preservation Highlight the Potential of PEDMARK^® to Address Cisplatin-Induced Hearing Loss, a Critical Survivorship Gap, Without Compromising Cisplatin’s Established Antitumor Activity –

– Majority of High-Risk Patients Receiving PEDMARK^® Demonstrated No Measurable Hearing Loss During or After Treatment Despite Prevalence of Baseline Hearing Impairment –

RESEARCH TRIANGLE PARK, N.C., Feb. 20, 2026 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today announced new real world data supporting potential use of PEDMARK^® (sodium thiosulfate injection) in adults with head and neck cancers were presented as a digital poster at the 2026 Multidisciplinary Head and Neck Cancers Symposium (MHNCS) in Palm Desert, CA from February 19 – 21, 2026.

Findings from a multi-institutional retrospective review of 15 adults with head and neck cancers (HNC) showed that PEDMARK^® could be safely given ≥six hours after cisplatin dosing and was easy to incorporate into the real-world care plan for adults with HNC. This strict post-cisplatin timing is a validated approach intended to preserve cisplatin antitumor activity and no disruption to curative-intent cisplatin-based treatment delivery was observed as part of the study review.

“Head and neck cancer is one of the most common cancers globally,¹ underscoring why these results are encouraging for clinicians. Importantly, the data support the potential of the drug to address cisplatin-induced hearing loss – a major and often overlooked survivorship challenge – without compromising cisplatin’s proven antitumor activity,” said Maria A. Velez, M.D., M.S., coauthor of the study and clinical instructor in the Division of Hematology/Oncology at UCLA Health.

“Cisplatin-induced hearing loss remains one of the most underrecognized yet deeply consequential toxicities associated with cancer treatment,” said Leslie Worona, FNP-BC, OCN, coauthor of the study and oncology nurse practitioner at Mount Sinai Hospital. “The findings that most patients – even those with high rates of pre-existing hearing impairment – who received PEDMARK^® experienced no measurable hearing loss during or after treatment supports further exploration of PEDMARK^® use in additional patient populations and tumor types such as HNC.”

PEDMARK was shown to be well tolerated, with only isolated, self-limited infusion events and no grade 3 or 4 toxicities.

“These new findings are critical to demonstrating the feasibility, scalability and long-term value of PEDMARK^® beyond those studied in our pivotal clinical program,” said Pierre S. Sayad, PhD, M.S., chief medical officer of Fennec Pharmaceuticals. “Additionally, these data may help to strengthen the case for broader clinical adoption in a sizable patient population at high risk for permanent hearing loss.”

The study’s primary endpoint evaluated feasibility, defined by timing adherence (≥6 hours) and operational metrics, including administration setting (home vs. clinic infusion) and chair time for infusion-center dosing. Secondary endpoints included infusion-related events, need for antiemetic escalation, and completion of on-treatment and post-treatment audiology assessments.

PEDMARK^® is currently approved for pediatric patients one month of age and older with localized, non-metastatic solid tumors, and is also recognized by the National Comprehensive Cancer Network with a 2A recommendation for use in adolescent and young adult patients.

About Cisplatin-Induced Ototoxicity
Cisplatin and other platinum-based chemotherapies are widely used to treat solid tumors and have been vital in improving survival rates. Unfortunately, these life-saving treatments often result in permanent, irreversible hearing loss, also known as ototoxicity.²

Hearing loss from cisplatin treatment is not rare. Studies show that between 60-90% of patients treated with cisplatin may develop hearing loss, depending upon the dose and duration of chemotherapy³. Many of those treated with cisplatin will 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.⁴ Treatment-induced hearing loss can reduce quality of survivorship as it impacts many aspects of life, such as speech and language skills, academic performance, social-emotional development, career potential and the ability to live independently.^5,6 While audiologic monitoring is recommended to help manage ototoxicity, it is currently underutilized in certain cancer patient populations.

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 1 month of age and older 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 first and only therapeutic agent with proven efficacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, the Children’s Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

Additionally, PEDMARK is recommended for the adolescent and young adult (AYA) population by the National Comprehensive Cancer Network, or NCCN, with a 2A endorsement.

Approximately 500,000 patients in the U.S. are diagnosed annually with cancers that could be treated with a platinum-based chemotherapy.^7,8 The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of those treated will require lifelong hearing aids. Until the FDA approval of PEDMARK, there were no preventative agents for this hearing loss. Patients with hearing loss resulting from cancer treatment have a statistically significant worse quality of life compared with peers who have no hearing loss.⁹¹⁰

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.

Indications and Usage
PEDMARK^® (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Limitations of Use
The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.

Important Safety Information
PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.

Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.

PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.

Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.

Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m².

Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.

The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.

Please see full Prescribing Information for PEDMARK^® at: www.PEDMARK.com.

About Fennec Pharmaceuticals
Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company committed to the fight against ototoxicity in cancer patients who receive cisplatin-based chemotherapy. Fennec is focused on the commercialization of PEDMARK^® to reduce the risk of platinum-induced ototoxicity in cancer patients. PEDMARK received FDA approval in September 2022 and European Commission approval in June 2023 and United Kingdom (U.K.) approval in October 2023 under the brand name PEDMARQSI.

In March 2024, Fennec entered into an exclusive licensing agreement under which Norgine Pharmaceuticals Ltd., a leading European specialist pharmaceutical company, will commercialize PEDMARQSI^® in Europe, U.K., Australia and New Zealand. PEDMARQSI is now commercially available in the U.K. and Germany.

PEDMARK has received Orphan Drug Exclusivity in the U.S. and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe which includes eight years plus two years of data and market protection. Further, Fennec has patents providing protection for PEDMARK until 2039 in both the U.S. and internationally.

For more information, please visit www.fennecpharma.com and follow on LinkedIn.

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^®/PEDMARQSI^®, the market opportunity for and market impact of PEDMARK^®/ PEDMARQSI^®, its potential impact on patients and anticipated benefits associated with its use, future commercial and regulatory milestone and royalty payments from Norgine, 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, 2024. 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.

PEDMARK^® PEDMARQSI^® and Fennec^® are registered trademarks of Fennec Pharmaceuticals Inc.

©2025 Fennec Pharmaceuticals Inc. All rights reserved. FEN-1604-v1

For further information, please contact:

Investors:
Robert Andrade
Chief Financial Officer
Fennec Pharmaceuticals Inc.
+1 919-246-5299

Corporate and Media:
Lindsay Rocco
Elixir Health Public Relations
+1 862-596-1304
lrocco@elixirhealthpr.com

¹ Mody MD, Rocco JW, Yom SS, et al: Head and neck cancer. Lancet 398:2289-2299, 2021.
² Rybak L. Mechanisms of Cisplatin Ototoxicity and Progress in Otoprotection. Current Opinion in Otolaryngology & Head and Neck Surgery. 2007, Vol. 15: 364-369.
³ Langer T, am Zehnhoff-Dinnesen A, Radtke S, Meitert J, Zolk O. Trends Pharmacol Sci. 2013;34(8):458-469
⁴ Landier W. Ototoxicity and Cancer Therapy. Cancer. June 2016 Vol. 122, No.11: 1647-1658.
⁵ Clemens E, van den Heuvel-Eibrink MM, Mulder RL, et al. Recommendations for ototoxicity surveillance for childhood, adolescent, and young adult cancer survivors: a report from the International Late Effects of Childhood Cancer Guideline Harmonization Group in collaboration with the PanCare Consortium. Lancet Oncol. 2019;20(1):e29-e41
⁶ . Bass JK, Knight KR, Yock TI, Chang KW, Cipkala D, Grewal SS. Evaluation and management of hearing loss in survivors of childhood and adolescent cancers: a report from the children’s oncology group. Pediatr Blood Cancer. 2016;63(7):1152-1162.
⁷ Chattaraj A et al. Cisplatin-Induced Ototoxicity: A Concise Review of the Burden, Prevention, and Interception Strategies. JCO Oncol Pract. 2023;19
⁸ Freyer DR et al. Effects of sodium thiosulfate versus observation on development of cisplatin-induced hearing loss in children with cancer (ACCL0431): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017;18(1):63-74.
⁹ Rajput K, Edwards L, Brock P, Abiodun A, Simpkin P, Al-Malky G. Ototoxicity-induced hearing loss and quality of life in survivors of paediatric cancer. Int J Pediatr Otorhinolaryngol. 2020;138:110401. doi:10.1016/j.ijporl.2020.110401
¹⁰ Bass JK, Knight KR, Yock TI, Chang KW, Cipkala D, Grewal SS. Evaluation and management of hearing loss in survivors of childhood and adolescent cancers: a report from the children’s oncology group. Pediatr Blood Cancer. 2016;63(7):1152-1162.

FAQ

What did Fennec announce about PEDMARK® use in adults with head & neck cancer (FENC) on Feb 20, 2026?

They reported a multi-institutional retrospective review of 15 adults showing PEDMARK® could be safely given ≥6 hours after cisplatin. According to the company, timing adherence, ease of integration and no disruption to curative cisplatin delivery were observed.

Does PEDMARK® reduce cisplatin-induced hearing loss in adults with head & neck cancer (FENC)?

Early signals indicate most high-risk patients experienced no measurable hearing loss during or after treatment. According to the company, the retrospective review found preservation of hearing despite baseline impairment in many patients.

Were there serious toxicities reported for PEDMARK® in the Feb 2026 FENC presentation?

No grade 3 or 4 toxicities were reported and only isolated, self-limited infusion events occurred. According to the company, PEDMARK® was well tolerated in the 15-patient retrospective review.

How was PEDMARK® integrated into real-world care for adults with head & neck cancers (FENC)?

PEDMARK® administration ≥6 hours post-cisplatin was incorporated into infusion workflows and home/clinic settings. According to the company, operational metrics showed feasibility and manageable chair time for infusion-center dosing.

What limitations did the Feb 2026 PEDMARK® data for head & neck cancer (FENC) have?

The study was retrospective with only 15 patients, limiting statistical power and causal inference. According to the company, findings are early signals that require prospective, larger studies for confirmation.

Is PEDMARK® currently approved for adult head & neck cancer patients (FENC)?

No; PEDMARK® is approved for pediatric localized non-metastatic solid tumors and has NCCN 2A recognition for adolescents/young adults. According to the company, adult HNC use is under further exploration based on these real-world data.