Fusion Pharmaceuticals reports Q3 EPS (25c), consensus (40c)

Reports Q3 revenue $2.0M, consensus $100K. Fusion expects its existing cash, cash equivalents and investments as of September 30, 2023 will be sufficient to fund operations into Q2 2025. CEO John Valliant commented, “In 2023, Fusion has focused on transitioning to a later stage company leading the development of next-generation radiopharmaceuticals that leverage the potency and precision of alpha-emitting particles. We believe in the potential of our diversified pipeline of targeted alpha therapy programs, our AstraZeneca collaboration, multiple actinium supply partnerships and our proprietary, state-of-the-art radiopharmaceutical manufacturing facility to produce innovative therapies for patients with multiple cancer types and create significant value. In Q3, we advanced patient enrollment in our Phase 2 clinical trial of FPI-2265, a small molecule-based TAT targeting prostate specific membrane antigen for the treatment of metastatic castration-resistant prostate cancer which is positioned to be the first actinium-based PSMA TAT to market. We are on track to report data on approximately 20 to 30 patients in 1Q24…We are also on track to share data from the second cohort in our Phase 1 study of FPI-1434 in patients with solid tumors expressing IGF-1R around the end of this year. In addition, we were pleased to share preclinical data…on FPI-2068, a jointly developed TAT with AstraZeneca targeting solid tumors expressing EGFR-cMET, which showed anti-tumor efficacy and confirmatory evidence of FPI-2068’s mechanism of action. These data were the basis for our IND clearance earlier this year, and we look forward to progressing the program into the previously announced Phase 1 clinical study. Finally, with manufacturing and supply chain expertise as a core foundation of Fusion, we are pleased with the progress in validation of our proprietary GMP radiopharmaceutical manufacturing facility, which we expect will be capable of producing up to 100,000 doses of drug per year. We look forward to beginning to produce clinical doses early in 2024 and are confident in the diversified supply chain we have invested in which supports our ability to deliver therapies to patients in need.”