Fennec Pharma(US:FENC)2022-06-04 14:59Company Overview - Fennec Pharmaceuticals is focused on developing PEDMARK™ to prevent cisplatin-induced ototoxicity in children aged 1 month to ≤ 18 years with localized, non-metastatic solid tumors[3] - The FDA assigned a PDUFA target action date of September 23, 2022, for PEDMARK™[3] - Fennec has patent protection in the U S until 2038 for the method of use for children <5 years of age and until 2039 for the unique anhydrous form of the active ingredient[4] - As of March 31, 2022, Fennec had USD $18 3 million in cash and cash equivalents and USD $5 million in debt[12] - In 2021, Fennec's cash burn was USD $14 2 million[12] PEDMARK™ Clinical Data - COG ACCL0431 study showed a 48% reduction in the risk of hearing loss with STS[48] - SIOPEL 6 study demonstrated a 48% decrease in the risk of hearing loss with STS[58] - In the SIOPEL 6 study, 63% of patients in the Cisplatin alone group experienced any grade hearing loss compared to 33% in the STS group[59] Market Opportunity - Approximately 70% of pediatric solid tumor cases in both the U S and European markets are localized, non-metastatic, representing 3,554 cases in the U S and 4,215 cases in Europe[23] - Cisplatin is a standard of care chemotherapy drug used to treat various childhood cancers[24, 25] - Up to 60% to 90% of children develop irreversible ototoxicity as a result of cisplatin treatment[31] - Among 226 survivors of non-CNS tumors, 39% had severe hearing loss, and 20% of these patients had hearing aids or cochlear implants[35]