Actinium Pharmaceuticals, Inc. — FY 2021 Form 10-K
Reporting period: Year ended December 31, 2021; comparisons are with FY 2020. The filing was signed March 25, 2022. Actinium is a clinical-stage biopharmaceutical company developing targeted radiotherapies and had no products approved for commercial sale.
Financial performance and position
| Metric | FY 2021 / Dec. 31, 2021 | FY 2020 / Dec. 31, 2020 |
|---|---|---|
| Commercial revenue | $0 | $0 |
| Other revenue | $1.144 million | $0 |
| Research and development expense, net | $18.031 million | $16.085 million |
| General and administrative expense | $8.077 million | $6.308 million |
| Net loss | $24.774 million | $22.215 million |
| Basic and diluted loss per share | $1.20 | $1.83 |
| Operating cash used | $20.866 million | $21.617 million |
| Cash and cash equivalents | $77.829 million | $63.560 million |
| Total current assets | $79.749 million | $64.925 million |
| Total current liabilities | $6.840 million | $4.767 million |
| Total liabilities | $6.843 million | $5.078 million |
Other revenue comprised approximately $0.9 million from collaboration research services and $0.2 million from an NIH-supported grant; it was not product-sale revenue. Operating expenses rose $3.715 million year over year, and the net loss widened by $2.559 million. Loss margins are not meaningful given the absence of commercial sales. Financing provided $35.221 million of net cash in 2021, primarily from issuing 4.589 million shares for $35.3 million net proceeds. Shares outstanding rose from 17.533 million to 22.144 million during the year.
Cash, cash equivalents and restricted cash totaled $78.221 million at year-end. Management stated that available resources were expected to fund planned operations for more than 12 months from the filing date, while cautioning that assumptions could change and additional financing would be needed for continued development and potential commercialization. Debt was limited: reported liabilities were primarily accounts payable, accrued expenses and lease obligations; no material conventional borrowings were reported. The filing reports no off-balance-sheet arrangements.
Business and material developments
- Iomab-B / SIERRA: The pivotal Phase 3 randomized trial in older patients with relapsed or refractory AML completed enrollment of 151 patients in Q3 2021; the last patient received a transplant in Q4. Interim data presented at ASH included transplant receipt in 59/59 study-arm patients given a therapeutic Iomab-B dose, compared with 13/76 control-arm patients receiving salvage therapy followed by transplant. These are interim results, not the primary endpoint outcome.
- Management expected SIERRA primary-endpoint topline data in Q3 2022 and anticipated a BLA filing in the first half of 2023, contingent on supportive results and regulatory progress. The primary endpoint is durable complete remission at 180 days; overall survival is secondary.
- Iomab-ACT: A first patient began treatment in a Memorial Sloan Kettering collaboration studying targeted conditioning before CAR-T therapy. Proof-of-concept data were expected in the second half of 2022.
- Actimab-A: A Phase 1 combination study with CLAG-M completed enrollment in November 2021. Reported results included a 67% overall response rate across dose cohorts and a recommended Phase 2 dose of 0.75 μCi/kg. A separate Phase 1/2 combination study with venetoclax reported preliminary tolerability and remission observations in a small dose-escalation cohort; development plans remained under evaluation.
- The company expanded its research capabilities and described collaborations involving Astellas, AVEO Oncology and EpicentRx. These research and preclinical programs remain subject to further study and are not established commercial opportunities.
Outlook, risks and unusual items
- No commercial revenue or profitability guidance was provided. Management expects continuing losses as it funds research, trials and development activities. The stated runway of more than 12 months was an estimate as of the March 2022 filing date, not a guarantee.
- Key risks include SIERRA failing to meet its endpoint or support approval; clinical safety or efficacy issues; regulatory delays or additional study requirements; reliance on third-party manufacturers and clinical-service providers; and availability of radioisotopes, particularly Ac-225. The DOE Ac-225 supply agreement was renewed through the end of 2022.
- The company depends on external capital and may issue additional equity, diluting existing shareholders. It sold 4.6 million shares under its $200 million at-the-market facility in 2021. Management also cited uncertainty in capital markets and possible changes in cash needs.
- COVID-19 had not had a financial impact to date, according to management, but could disrupt trials, suppliers, operations or access to capital. The filing also notes competitive, reimbursement, intellectual-property, staffing and cybersecurity risks.
- Commitments include a $1 million milestone payment to Fred Hutchinson Cancer Center upon FDA approval of the first drug using the licensed antibody, plus royalties of 2% of net sales after commercial sale. No material pending legal proceedings were identified.
- The financial statements received an unqualified audit opinion, with no critical audit matters reported. Management concluded internal control over financial reporting was effective; the auditor did not provide an internal-control attestation because the company was a non-accelerated filer.
Important facts for investors to verify
- Final SIERRA primary-endpoint and overall-survival results, including how crossover patients are treated in the analysis, and whether results support the proposed BLA timeline.
- Actual cash burn and financing needs against the stated runway, and potential dilution from further equity sales, options and warrants.
- Whether preliminary Actimab-A and Iomab-ACT findings are confirmed in larger or later-stage studies, including full safety data.
- Continuity and scalability of third-party manufacturing and isotope supply, including renewal of the DOE Ac-225 agreement after 2022.
- Potential approval, reimbursement, commercial-launch costs and partnership arrangements; the filing provides no clear quantified commercial forecast.