GlobeNewswire Inc | Jan 31, 2022 06:00AM EST

January 31, 2022

RESEARCH TRIANGLE PARK, N.C., Jan. 31, 2022 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARK(a unique formulation of sodium thiosulfate) for the prevention of platinum-induced ototoxicity in pediatric patients, today announced that Shubh Goel, the Companys chief commercial officer, has tendered her resignation and will depart Fennec in late February.

On behalf of the Board of Directors and leadership team, we thank Shubh for her many contributions to the Company. We continue to prepare for a commercial launch upon approval, said Rosty Raykov, chief executive officer ofFennec Pharmaceuticals, Inc. Fennec remains committed to making PEDMARKavailable to children and young adults receiving cisplatin chemotherapy, who currently have no approved therapies for ototoxicity.

About Fennec Pharmaceuticals

Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development of PEDMARKfor the prevention of platinum-induced ototoxicity in pediatric patients. Further, PEDMARK has received Orphan Drug Designation in the U.S. for this potential use. Fennec has a license agreement withOregon Health and Science University(OHSU) for exclusive worldwide license rights to intellectual property directed to sodium thiosulfate and its use for chemoprotection, including the prevention of ototoxicity induced by platinum chemotherapy, in humans. For more information, please visitwww.fennecpharma.com

About PEDMARK

Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible and particularly harmful to the survivors of pediatric cancer.

In the U.S. andEurope,it is estimated that, annually, over 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 cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol 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, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

PEDMARK has received Breakthrough Therapy and Fast Track Designation by the FDA inMarch 2018. The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) is currently under evaluation by theEuropean Medicines Agency(EMA).

Forward Looking Statements

Except for historical information described in this press release, all other statements are forward-looking. These forward-looking statements include the Companys expectations regarding its interactions and communications with the FDA and, pending FDA approval, the Companys planned commercial launch of PEDMARK. Forward-looking statements are subject to certain risks and uncertainties inherent in the Companys business that could cause actual results to vary, including such 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, Fennecs reliance on third party manufacturing, 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 Companys patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Companys products will not be as large as expected, the Companys products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Companys filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2020 and its Quarterly Report on Form 10-Q for the quarter endedSeptember 30, 2021. 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 AndradeChief Financial OfficerFennec Pharmaceuticals Inc.(919) 246-5299

Media:Elixir Health Public RelationsLindsay Rocco(862) 596-1304lrocco@elixirhealthpr.com