Actinium Pharmaceuticals (ATNM) Q4 2022 earnings summary

Executive summary

• Clinical-stage radiotherapeutics portfolio targets high-unmet-need cancers, led by Iomab-B for transplant conditioning and Actimab-A as AML therapy.

• Phase 3 SIERRA met its durable complete remission endpoint; full results highlighted improved transplant access, survival and tolerability, supporting a planned BLA filing.

Financial highlights

• FY22 revenue was $1.03M, all noncommercial; operating expenses were $35.1M and net loss was $33.0M, versus $24.8M in FY21.

• R&D expense rose to $23.1M from $18.0M, mainly from Iomab-B CMC work and higher compensation; G&A increased to $12.0M from $8.1M.

• Year-end cash and equivalents were $108.9M; net cash rose $31.4M in FY22, including the $35M Immedica upfront payment.

Outlook and guidance

• Planned Iomab-B BLA filing in H2 2023, early access program, and potential U.S. launch in 2024, subject to approval.

• Late-stage Actimab-A development was expected to begin in H2 2023 under the NCI CRADA; Iomab-ACT proof-of-concept data were expected in 2023.

• Year-end cash was projected to fund operations through 2025; the filing separately stated existing resources were expected to fund planned operations for more than 12 months after filing.