Fennec Pharma(FENC) - 2025 Q4 - Annual Results

Financial Performance - Full-year net product sales for PEDMARK® reached $44.6 million, representing a 50% year-over-year growth, with Q4 2025 net product sales of $13.8 million, reflecting a 75% increase over Q4 2024[1] - The company completed an oversubscribed equity offering, raising $42 million from new and existing investors, strengthening its financial position[2] - Cash and cash equivalents as of December 31, 2025, were $36.7 million, reflecting a $10.2 million increase from the previous year, primarily due to equity offerings and product sales[13] - The total assets of the company increased to $70.2 million as of December 31, 2025, compared to $44.9 million in 2024[15] - The company reported a net loss of $5.1 million for Q4 2025, compared to a net loss of $1.6 million in Q4 2024[14] - Selling and marketing expenses for Q4 2025 were $6.1 million, up from $3.9 million in Q4 2024, primarily due to increased payroll and marketing efforts[9] - General and administrative expenses increased to $8.9 million in Q4 2025 from $4.2 million in Q4 2024, driven by higher legal and payroll costs[13] - The weighted-average number of common shares outstanding increased to 31.2 million in Q4 2025 from 27.5 million in Q4 2024[14] Clinical Development - The company initiated two institution-led clinical studies to evaluate PEDMARK® for preventing cisplatin-induced ototoxicity in adult patients[8] - Positive topline results were announced from a Phase 2/3 clinical trial in Japan, demonstrating PEDMARK®'s efficacy in protecting hearing without compromising cisplatin's effectiveness[8] - PEDMARK has shown proven efficacy and safety across two Phase 3 clinical studies, COG ACCL0431 and SIOPEL 6, which have been completed[19] - The most common adverse reactions in clinical trials included vomiting, nausea, decreased hemoglobin, and hypernatremia, with hypersensitivity reactions occurring in 8% to 13% of patients[26][23] Regulatory Approvals - PEDMARK® is the first FDA-approved therapy to reduce the risk of ototoxicity from cisplatin in pediatric patients aged 1 month and older[17] - PEDMARK received FDA approval in September 2022 and European Commission approval in June 2023, with U.K. approval in October 2023[28] Market Strategy - Fennec Pharmaceuticals entered an exclusive licensing agreement with Norgine Pharmaceuticals for the commercialization of PEDMARQSI® in Europe, U.K., Australia, and New Zealand[29] - PEDMARK has Orphan Drug Exclusivity in the U.S. and PEDMARQSI has Pediatric Use Marketing Authorization in Europe, providing eight years plus two years of data and market protection[30] - The company anticipates potential commercial and regulatory milestones and royalty payments from Norgine as part of its forward-looking strategy[31] - Fennec holds patents for PEDMARK until 2039 in both the U.S. and internationally, ensuring long-term market protection[30] Safety Monitoring - The company emphasizes the importance of monitoring for adverse reactions, particularly hypersensitivity and electrolyte imbalances, during PEDMARK administration[24][25] - Approximately 500,000 patients in the U.S. are diagnosed annually with cancers treatable by platinum-based chemotherapy, with 60-90% potentially developing hearing loss[19]