Mr. Rosty Raykov reports

FENNEC PHARMACEUTICALS AND NORGINE ENTER INTO EXCLUSIVE LICENSING AGREEMENT TO COMMERCIALIZE PEDMARQSI IN EUROPE, AUSTRALIA, AND NEW ZEALAND

Fennec Pharmaceuticals Inc. and Norgine, a leading European specialist pharmaceutical company, have signed an exclusive licensing agreement under which Norgine will commercialize Pedmarqsi in Europe, Australia and New Zealand. Pedmarqsi is the first and only approved therapy in the European Union and United Kingdom for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients one month to less than 18 years of age with localized, non-metastatic solid tumours.

Under the terms of the licensing agreement, Fennec will receive 40 million euros in upfront consideration and up to 210 million euros in additional commercial and regulatory milestone payments and double-digit tiered royalties on net sales of Pedmarqsi in the licensed territories up to the mid-twenties. Norgine will be responsible for all commercialization activities in the licensed territories, and will hold all marketing authorizations in the licensed territories.

It is estimated that more than 5,000 pediatric patients annually are eligible for platinum-based chemotherapy in Europe. Pedmarqsi was granted EU marketing authorization by the European Commission in June, 2023, and received U.K. approval from the Medicines and Healthcare Products Regulatory Agency in October, 2023. Approvals were based on safety and efficacy data from two open-label, randomized phase 3 trials: Siopel 6 (pivotal) and clinical oncology group protocol ACCL0431. The studies compared Pedmarqsi plus cisplatin-based regimens with cisplatin-based regimens alone for the reduction of cisplatin-induced hearing loss in pediatric patients. Pedmarqsi holds eight years plus two years of data and market protection in Europe based on its pediatric use marketing authorization. Approval in Switzerland, Australia and New Zealand will also be pursued.

The first study (Siopel-6) involved 114 children with hepatoblastoma (a cancer of the liver), with an average age of about 19 months. The results showed that 35 per cent (20 out of 57) of children who received Pedmarqsi six hours after each dose of cisplatin developed hearing loss compared with 67 per cent (35 out of 52) of children who only received cisplatin. The second study involved 125 children aged one month to 18 years with different types of cancer, including hepatoblastoma, neuroblastoma (a cancer of immature nerve cells) and tumours of the central nervous system. The study found that hearing loss was experienced by 29 per cent (14 out of 49) of children who received Pedmarqsi after each cisplatin dose compared with 56 per cent (31 out of 55) of those who received only cisplatin.

"We are delighted to partner with Norgine, who shares our belief in the potential of Pedmarqsi to mitigate the risk of permanent and irreversible hearing loss that can occur in pediatric patients treated with cisplatin. Further, this partnership is an important step in achieving our mission of expanding Pedmarqsi to patients across the globe who are at risk of suffering from cisplatin-induced ototoxicity," said Rosty Raykov, chief executive officer of Fennec. "From a deal perspective, the terms provided us many important benefits, including an upfront payment, further solidifying our balance sheet, attractive economic terms providing meaningful participation in the ex-U.S. success of Pedmarqsi and an experienced partner to successfully launch Pedmarqsi in the licensed territory."

Chris Bath, chief executive officer of Norgine, said: "We are thrilled to announce our partnership with Fennec to bring this vital medicine to pediatric patients who are being treated with cisplatin across Europe and ANZ. We look forward to working with the Fennec team and launching Pedmarqsi in our territories in the coming months, establishing it as the standard of care in this critical patient population with high unmet need. This important milestone for our company builds on our 30-year track record of creating partnerships of enduring value and further underscores Norgine's position as the specialty pharma partner of choice across Europe and ANZ."

Moelis & Company LLC acted as financial adviser, and LaBarge Weinstein LLP acted as legal adviser to Fennec. Arnold & Porter acted as legal adviser to Norgine.

About Fennec Pharmaceuticals Inc.

Fennec is a specialty pharmaceutical company focused on the development and commercialization of Pedmark and Pedmarqsi to reduce the risk of platinum-induced ototoxicity in pediatric patients. Pedmark received Food and Drug Administration approval in September, 2022, and European Commission marketing authorization in June, 2023, for Pedmarqsi. Further, Pedmarqsi received U.K. approval in October, 2023. Pedmark has received orphan drug exclusivity in the United States 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.

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