Actinium Pharmaceuticals, Inc. — Q1 2022 Form 10-Q
Reporting period: Three months ended March 31, 2022. Financial statements are unaudited. Actinium is a clinical-stage biopharmaceutical company developing targeted radiotherapies; it reported no commercial product sales.
Key financial metrics
| Metric | Q1 2022 | Q1 2021 / comparison |
|---|---|---|
| Commercial revenue | $0 | $0 |
| Other revenue | $0.940 million | $0.622 million |
| Research and development expense, net | $4.369 million | $4.276 million |
| General and administrative expense | $1.735 million | $1.718 million |
| Total operating expenses | $6.104 million | $5.994 million |
| Operating loss | $5.164 million | $5.372 million |
| Net loss | $5.129 million | $5.320 million |
| Net loss per share, basic and diluted | $0.23 | $0.29 |
| Cash used in operating activities | $5.781 million | $5.642 million |
Other revenue comprised approximately $0.8 million from collaboration research services and $0.1 million from a government-sponsored research grant. The filing does not provide a meaningful commercial gross margin. Net loss improved by $0.191 million, primarily due to higher other revenue; operating expenses rose by $0.110 million. Weighted-average shares increased to 22.14 million from 18.38 million, contributing to the lower loss per share.
At March 31, cash and cash equivalents were $72.019 million, with another $0.392 million of restricted cash; total current assets were $74.053 million and current liabilities were $5.723 million. Total liabilities were $5.725 million, including lease obligations; the filing reports no conventional borrowings. Cash, cash equivalents and restricted cash declined $5.810 million during the quarter. Management stated that resources were expected to fund planned operations for more than 12 months following the filing date.
Material changes and subsequent events
- Compared with Q1 2021, other revenue increased $0.318 million, R&D increased $0.093 million, and G&A was nearly unchanged. Operating cash use increased $0.139 million.
- No shares were sold under the company’s equity sales agreement during Q1 2022; Q1 2021 financing included $14.361 million of net stock-sale proceeds.
- After quarter-end, Actinium licensed exclusive Iomab-B commercialization rights in specified EUMENA territories to Immedica. The agreement provided a $35 million upfront payment, received in May 2022, potential regulatory and commercial milestones of up to approximately $417 million, and royalties in the mid-20% range on net sales in certain countries. Actinium retains U.S. and other stated rights and remains responsible for certain development and manufacturing activities.
- After quarter-end, the company sold 1.6 million shares for $11.1 million in net proceeds. The filing reported unaudited cash of approximately $115 million as of May 13, 2022, reflecting the upfront payment and share sales.
Outlook, programs and principal risks
- Actinium expected SIERRA Phase 3 topline data on Iomab-B’s primary endpoint in Q4 2022 and anticipated filing a BLA in the first half of 2023, subject to trial results and regulatory requirements. Enrollment was completed; reported SIERRA safety and feasibility findings were interim or preliminary and may change.
- Management reported encouraging early results in Actimab-A combination studies and expected Iomab-ACT proof-of-concept data from the MSK collaboration in the second half of 2022. These programs remain investigational.
- Key risks include failure to demonstrate clinical safety or efficacy or obtain regulatory approval, dependence on Iomab-B and SIERRA, trial delays, reliance on third-party manufacturers and isotope suppliers, financing needs and potential shareholder dilution, and uncertainty around commercialization and reimbursement. COVID-19 could disrupt trials, suppliers or regulatory activity; management said it had not caused a financial impact to date.
- The company disclosed a potential $1 million payment to Fred Hutchinson Cancer Research Center upon FDA approval of the first drug using the licensed antibody, plus 2% royalties on net sales upon commercial sale. No legal proceedings were reported.
Important facts for investors to verify
- Final SIERRA primary-endpoint results, including how final data compare with the reported interim findings, and whether they support a BLA filing on the stated timetable.
- Receipt and terms of the Immedica upfront payment, territory-specific royalty and milestone conditions, and Actinium’s continuing development and manufacturing obligations.
- Cash burn, operating runway and any subsequent equity issuance or dilution; the May 13 cash figure is unaudited and includes post-quarter transactions.
- Progress and safety data from Actimab-A and Iomab-ACT trials, and the adequacy and continuity of clinical and potential commercial isotope and drug-product supply.