Actinium Pharmaceuticals, Inc. (ATNM)

Actinium Pharmaceuticals, Inc. 10‑K Financial Analyst Report

Report Date: 2025‑03‑31
Period Covered: Fiscal Year ended December 31, 2024
Form Type: 10‑K

1. Executive Summary

• Actinium generated $0 in product revenue; R&D grants were the sole revenue source.
• Recorded a net loss of $38.24 M, vs. $48.82 M net loss in FY 2023 (a 21.6% improvement).
• Cash and equivalents stood at $72.9 M at year end, with $32.4 K restricted under lease collateral.
• Run‑rate and cash position fund operations into Q1 2026, but further capital raises are likely before pivotal trials.

2. Profit & Loss Analysis

• Revenue: $0 from product; $~1 M recognized from NIH/MSK R&D grants.
• R&D Expense: $30.0 M (–22.3% vs. $38.7 M in 2023), driven by reduced CMC spend and headcount reductions, offset by increased preclinical activity.
• G&A Expense: $12.1 M (–9.4% vs. $13.3 M in 2023) from lower consulting, legal and compensation costs.
• Net Loss: $38.24 M vs. $48.82 M.

Drivers of Loss Reduction

• Headcount cuts and shifted external spend post‑Phase III enablement work.
• Lower professional fees and moderate overhead control.
• Partially offset by ramp‑up of preclinical solid‑tumor programs.

3. Balance Sheet & Cash Flow

• Cash & Equivalents: $72.9 M; Restricted Cash: $0.3 M.
• Operating Cash Burn: $33.1 M in FY 2024 vs. $47.3 M in FY 2023.
• Financing: $29.3 M net proceeds from ATM equity sales.
• Lease Liabilities: Operating and finance ROU assets total $2.6 M; obligations of $1.6 M (2025–2027).

4. Pros and Cons

Pros

• Narrowing losses and proactive cost management extend runway.
• Robust pipeline with two Phase II clinical assets in oncology; multiple INDs planned.
• Exclusive EU/MENA Iomabact license infuses $35 M upfront.
• Proprietary cyclotron‑based Ac‑225 production platform ensures isotope supply and potential cost advantage.

Cons

• No commercial product revenue; ongoing burn requires further financing.
• High clinical and regulatory risk: additional trials mandated by FDA for Iomabact.
• Dense competitive landscape in AML, PSMA‑targeted and conditioning markets.
• Dependency on third‑party CDMOs, isotope suppliers and CROs for execution.

5. Outlook & Recommendations

• Expect continued non‑dilutive grant/license milestones and ATM raises before mid‑2026.
• Monitor Phase III for Iomabact and pivotal Phase II/III design for Actimaba‑CLAGM combination.
• Success catalysts: FDA guidance on additional trials, Phase II data readouts (H2 2025), cyclotron facility build in Q2 2025.
• Risk mitigation: partnerships for late‑stage development, diversification of isotope suppliers, and proactive fundraising.

Revenue Streams (FY 2024)

• NIH/MSK R&D grants: _{100% of recognized revenue (}$1 M)
• License & Milestone Revenue: $0 (no EU approval milestones hit in 2024)

Comparative FY 2023 Streams

• NIH grants: ~$1 M
• Iomabact upfront license deferred ($35 M) – recognized upon EU approval (H1 2025)

Actinium has steadily reduced its burn rate and narrowed net losses through strategic cost cuts, while maintaining key R&D momentum across its radiotherapeutics platform. Its cash runway now extends into early 2026, but pivotal trials and regulatory requirements will demand fresh financing. The company’s unique alpha‑particle isotope production capabilities and robust intellectual property offer a competitive advantage. Future growth hinges on clinical readouts in H2 2025, clarity from the FDA on Iomabact’s pathway, and successful ATM equity raises or partnerships to fund late‑stage programs. Management’s ability to de‑risk the development plan with collaborators and to secure diversified isotope supply will shape long‑term sustainability.