Actinium Pharmaceuticals, Inc. — FY 2023 Form 10-K
Reporting period: Fiscal year ended December 31, 2023; comparative figures are for FY 2022. This is an annual report, not a standalone fourth-quarter report. Actinium is a clinical-stage radiotherapeutics company with no approved products or commercial product sales.
Key financial metrics
| Metric | FY 2023 | FY 2022 |
|---|---|---|
| Commercial revenue | $0 | $0 |
| Total revenue, including grant/collaboration revenue | $81,000 | $1.03 million |
| Research and development expense, net | $38.67 million | $23.14 million |
| General and administrative expense | $13.33 million | $12.00 million |
| Net loss | $48.82 million | $33.02 million |
| Basic and diluted loss per share | $1.83 | $1.37 |
| Cash used in operating activities | $47.34 million | Cash provided: $8.64 million |
| Cash and cash equivalents at year-end | $76.68 million | $108.91 million |
Operating margin is not meaningful given the absence of commercial sales and ongoing losses. The filing reports no conventional borrowing; year-end liabilities included $35 million of deferred license revenue and lease obligations. Total liabilities were $45.07 million, and stockholders’ equity was $36.38 million. The $35 million Immedica upfront license payment remains deferred and is expected to be recognized upon EU regulatory approval of Iomab-B.
Business, pipeline and material changes
- Iomab-B: The company is developing this targeted conditioning therapy for relapsed or refractory acute myeloid leukemia (r/r AML) patients proceeding to bone marrow transplant (BMT). In the 153-patient Phase 3 SIERRA trial, the primary endpoint of durable complete remission was met (p<0.0001). The company reported a 22% six-month durable remission rate versus 0% in control.
- Survival interpretation: The secondary overall-survival endpoint was not met in the intent-to-treat analysis, which the company says was confounded by control-arm crossover. Exploratory comparisons reported median survival of 6.4 months for Iomab-B versus 3.2 months for non-crossover controls. These exploratory findings are not the same as a positive ITT survival result.
- Actimab-A: Early-stage combination results include reported 1-year survival of 48% across treated patients in the Actimab-A plus CLAG-M trial and 46% among patients with prior venetoclax treatment in updated data presented in 2023. The program is planned to advance with support from an NCI cooperative agreement.
- Iomab-ACT: The company is studying targeted conditioning before CAR-T therapy with MSKCC; a separate study with commercial CAR-T was announced in March 2024, subject to FDA review and clearance.
- R&D expense rose by $15.54 million, primarily due to Iomab-B chemistry, manufacturing and controls work for planned U.S. and European filings and increased headcount. Net loss widened by $15.80 million. Higher interest income partly offset increased expenses.
Liquidity, outlook, risks and unusual items
- Management reported unaudited cash of $84.3 million as of March 27, 2024, including $14.7 million net proceeds from selling 1.8 million shares after year-end. Management estimated this cash would fund operations into the second half of 2026; this is an estimate dependent on assumptions and spending needs.
- The company intends to submit an Iomab-B BLA to the FDA in 2024 and is supporting Immedica’s planned EUMENA marketing application. Management stated that, based on current assumptions, regulatory approvals might be possible in 2025. Neither filing nor approval is assured.
- FY 2023 financing included $14.6 million net proceeds from common-stock sales. The company has an effective shelf registration statement and an at-the-market sales agreement, creating potential for further equity issuance and dilution.
- Principal risks include regulatory review and approval, clinical efficacy and safety, reimbursement and market adoption, continued financing needs, reliance on third-party manufacturers and isotope suppliers, and protection of intellectual property. The company also notes that its clinical-stage business has incurred losses in every year since inception.
- Auditors issued an unqualified opinion on the financial statements and reported no critical audit matters. Management assessed internal control over financial reporting as effective; the auditor did not provide an internal-control attestation because the company is a non-accelerated filer.
Important facts for investors to verify
- Current FDA and EMA filing status, completeness of the Iomab-B applications, and any additional clinical, CMC or manufacturing requirements.
- How regulators assess SIERRA’s crossover design, the unmet ITT overall-survival endpoint, and the exploratory survival analyses.
- Cash burn and runway against actual spending, planned trials, commercialization preparation and any further equity issuance.
- Immedica’s MAA progress and the conditions for recognizing the $35 million deferred license payment, plus the contingent milestones and royalties.
- Dependability and commercial-scale capacity of isotope suppliers and contract manufacturers, including Ac-225 supply and the company’s claimed cyclotron production capabilities.