Mr. Robert Andrade reports

FENNEC PHARMACEUTICALS PRESENTS REAL WORLD DATA SUPPORTING THE INTEGRATION AND CLINICAL USE OF PEDMARK IN TREATING ADULTS WITH HEAD & NECK CANCERS

Fennec Pharmaceuticals Inc. has released new real-world data supporting potential use of Pedmark (sodium thiosulphate 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, Calif., from Feb. 19 to Feb. 21, 2026.

Findings from a multiinstitutional retrospective review of 15 adults with head and neck cancers (HNC) showed that Pedmark could be safely given greater than or equal to six hours after cisplatin dosing and was easy to incorporate into the real-world care plan for adults with HNC. This strict postcisplatin timing is a validated approach intended to preserve cisplatin anti-tumour 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, 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 anti-tumour activity," said Dr. Maria A. Velez, MD, MS, co-author 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, co-author 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 tumour types such as HNC."

Pedmark was shown to be well tolerated, with only isolated, self-limited infusion events and no Grade 3 or Grade 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 Dr. Pierre S. Sayad, PhD, MS, 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 end point evaluated feasibility, defined by timing adherence (greater than or equal to six hours) and operational metrics, including administration setting (home versus clinic infusion) and chair time for infusion-centre dosing. Secondary end points included infusion-related events, need for anti-emetic escalation, and completion of on-treatment and posttreatment audiology assessments.

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

About Fennec Pharmaceuticals Inc.

Fennec Pharmaceuticals 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 (U.S. Food and Drug Administration) approval in September, 2022, and European Commission approval in June, 2023, and United Kingdom 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, the United Kingdom, Australia and New Zealand. Pedmarqsi is now commercially available in the United Kingdom and Germany.

Pedmark has received orphan drug exclusivity in the United States 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 both in the United States and internationally.

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