Actinium Pharmaceuticals (ATNM) Q4 2023 earnings summary

Executive summary

• Clinical-stage radiotherapeutics pipeline centers on Iomab-B for targeted conditioning in relapsed/refractory AML and Actimab-A as a combination therapy; no commercial product revenue was recorded in 2023.

• FY23 net loss widened to $48.8M from $33.0M, while year-end cash was $76.7M; unaudited cash of $84.3M on March 27, 2024 was expected to fund operations into H2 2026.

Financial highlights

• Total revenue was $81K in FY23 versus $1.03M in FY22; FY23 included $0.1M of grant revenue and no commercial sales revenue.

• R&D expense rose to $38.7M from $23.1M, primarily on Iomab-B CMC and BLA/MAA preparation and $4.3M higher compensation; G&A increased to $13.3M from $12.0M.

• Net loss was $48.8M, or $1.83/share, versus $33.0M, or $1.37/share, in FY22; net interest income increased to $3.1M from $1.1M.

• Operating cash used was $47.3M versus $8.6M provided in FY22; FY22 included the $35M Immedica upfront payment.

Outlook and guidance

• Iomab-B BLA submission is targeted for 2024; an FDA meeting on clinical and nonclinical sections was expected in Q2 2024, and potential regulatory approval was forecast for 2025 based on current assumptions.

• Immedica is proceeding with an EUMENA MAA filing after regulatory discussions; regulatory review and approval remain subject to agency decisions.

• Cash of $84.3M as of March 27, 2024 was expected to fund operations into H2 2026, supporting Iomab-B regulatory work and continued Actimab-A, Iomab-ACT and R&D programs.