18:52:44 EDT Mon 29 Apr 2024
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Fennec Pharmaceuticals Inc
Symbol FRX
Shares Issued 27,036,696
Close 2024-02-29 C$ 12.89
Market Cap C$ 348,503,011
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Fennec expects revenue of $20.7M to $21.2M for 2023

2024-02-29 12:24 ET - News Release

Mr. Robert Andrade reports

FENNEC PHARMACEUTICALS REPORTS PRELIMINARY UNAUDITED NET REVENUE FOR FOURTH QUARTER AND FULL-YEAR 2023 RESULTS

Fennec Pharmaceuticals Inc. has released its preliminary unaudited fourth quarter and full-year 2023 net revenues. The information in this press release is based upon preliminary unaudited information and management estimates for the fourth quarter 2023 and is subject to the completion of Fennec's financial closing procedures and year-end audit.

Preliminary unaudited 2023 fourth quarter revenue and year-end performance:

  • Fourth quarter 2023 net revenues are expected to be approximately $9.2-million to $9.7-million, which represents approximately a 41-per-cent to 49-per-cent increase over the third quarter of 2023.
  • Full-year 2023 net revenues are expected to be approximately $20.7-million to $21.2-million.
  • Fennec expects to report its 2023 fourth quarter and audited full-year results of operations on or about March 26, 2024.

Pedmark (sodium thiosulphate 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 with localized, non-metastatic, solid tumours. It is a unique formulation of sodium thiosulphate in single-dose, ready-to-use vials for intravenous use in pediatric patients. Pedmark is also the only therapeutic agent with proven efficacy and safety data with an established dosing paradigm across two open-label, randomized phase 3 clinical studies -- the Clinical Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

In the United States and Europe, it is estimated that, annually, more than 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 suboptimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children who 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 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 tumour, osteosarcoma, neuroblastoma, medulloblastoma and other solid tumours. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumours.

About Fennec Pharmaceuticals Inc.

Fennec Pharmaceuticals 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. Further, Pedmark received FDA approval in September, 2022, and European Commission marketing authorization in June, 2023, for Pedmarqsi. 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. Fennec has a licence agreement with Oregon Health and Science University (OHSU) for exclusive worldwide licence rights to intellectual property directed to sodium thiosulphate and its use for chemoprotection, including the reduction of risk of ototoxicity induced by platinum chemotherapy, in humans.

We seek Safe Harbor.

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