Fennec Pharmaceuticals (FENC) H.C. Wainwright 4th Annual BioConnect Investor Conference summary

Product overview and clinical impact

• PEDMARK is the first and only approved agent to prevent hearing loss associated with cisplatin chemotherapy, which is widely used across all age groups and can cause hearing loss in up to 75% of patients.

• Two phase III trials, including one published in the New England Journal of Medicine, showed PEDMARK statistically reduced hearing loss, with a number needed to treat (NNT) of three.

• The product was initially approved for pediatric use, with subsequent expansion into the adolescent and young adult (AYA) market, which is ten times larger than the pediatric segment.

• Awareness among oncologists remains low, presenting significant growth opportunities as education and outreach expand.

• Real-world evidence from investigator-sponsored trials (ISTs) is being generated to support broader adoption and potential guideline upgrades.

Commercial strategy and market expansion

• Revenue nearly doubled since leadership changes, reaching a record $15.1 million in Q1 2026, with growth driven by expansion into the AYA market and increased sales force coverage.

• The company expanded its commercial organization from 10 to 24 territories, targeting over 5,400 sites and enabling home administration through the Fennec HEARS program.

• Outpatient administration in the AYA market supports a cost-plus pricing model, while pediatric use remains largely inpatient.

• Education and frequency of engagement are key pillars for continued growth in 2026.

Regulatory and clinical development

• PEDMARK holds a Category 2A NCCN guideline recommendation for AYA, with ongoing ISTs aimed at generating real-world data to support a potential upgrade to Category 1 and expansion into adult populations.

• Three ISTs are currently enrolling, with interim data expected as early as January next year.

• Expansion into adult indications could unlock a significantly larger market, as most cisplatin use occurs in adults.