Actinium Pharmaceuticals, Inc. — Q2 2023 Form 10-Q
Reporting period: Quarter and six months ended June 30, 2023. Financial statements are unaudited. Actinium is a clinical-stage company developing targeted radiotherapies; it reported no commercial revenue.
Financial results and liquidity
| Metric | Q2 2023 | Q2 2022 | Six months 2023 | Six months 2022 |
|---|---|---|---|---|
| Revenue, including other revenue | $0 | $45,000 | $0 | $985,000 |
| Research and development expense, net | $11.1 million | $4.7 million | $18.9 million | $9.0 million |
| General and administrative expense | $4.6 million | $3.2 million | $8.3 million | $5.0 million |
| Net loss | $15.2 million | $7.8 million | $26.2 million | $12.9 million |
| Basic and diluted loss per share | $0.58 | $0.33 | $1.01 | $0.56 |
- At June 30, cash and cash equivalents were $91.3 million; total cash, cash equivalents and restricted cash were $91.6 million, down from $109.6 million at December 31, 2022. Current assets were $95.5 million and current liabilities $9.2 million.
- Six-month operating cash use was $28.7 million; investing cash use was $0.1 million; financing provided $10.8 million, primarily from stock sales. The reported prior-year operating cash inflow of $22.1 million included Immedica’s $35 million upfront payment.
- Total liabilities were $46.0 million, including $35.0 million of deferred license revenue and operating lease obligations. The filing reports no debt borrowings. Stockholders’ equity was $53.1 million.
- Management expected available resources to fund planned operations through 2025 and, as of the filing date, for more than 12 months. This is management’s estimate, not assurance of adequate funding for all plans.
Material changes and business developments
- Six-month operating expenses rose to $27.2 million from $14.0 million, primarily from higher R&D spending for Iomab-B chemistry, manufacturing and controls work ahead of a planned BLA filing, and increased headcount. G&A also rose, including compensation, equity compensation and professional fees.
- Net loss increased by $13.3 million year over year for the first half. Interest income rose to $1.0 million from $0.1 million, partly offsetting the higher operating costs.
- The company raised $10.6 million net through sales of 1.3 million common shares during the first half under its at-the-market sales agreement. Shares outstanding were 26.98 million at June 30, versus 25.67 million at year-end.
- The $35 million Immedica upfront payment remains deferred as a long-term liability and is expected to be recognized upon EU regulatory approval of Iomab-B. The agreement also provides for potential milestones and mid-20% royalties on certain regional net sales.
Outlook, commentary and risks
- Management said it was working toward submitting an Iomab-B BLA to the FDA by the end of 2023, pursuing an early access program, and targeting a U.S. launch in 2024 if approved. It was also working with Immedica toward an EU marketing application, with filing expected in 2024.
- Management reported that the Phase 3 SIERRA trial met its primary endpoint of six-month durable complete remission (dCR; p<0.0001). It also disclosed important endpoint context: the secondary endpoint of overall survival was not met in the intent-to-treat analysis, which management said was confounded by crossover. Exploratory analyses reported median overall survival of 6.4 months for the Iomab-B group versus 3.2 months for non-crossover control patients; these are exploratory comparisons, not the primary endpoint.
- Actinium planned to provide updates on late-stage Actimab-A development with the NCI and expected proof-of-concept data from its Actimab-A/venetoclax and Iomab-ACT studies in the second half of 2023. These are forward-looking plans.
- Key risks include FDA review or requests for additional data, clinical safety or efficacy uncertainty, commercialization and reimbursement challenges, reliance on third-party manufacturers and isotope suppliers, and the need for further financing. Future equity sales could dilute shareholders. The company has no approved products or product-sales revenue.
- The filing reports no legal proceedings under the legal-proceedings item, but separately describes arbitration involving a former employee over alleged confidentiality and non-compete violations. A permanent injunction was issued in April 2023, including a restriction through April 1, 2024; investors should verify the current status and any material developments.
- Management concluded disclosure controls were effective as of June 30, 2023 and reported no material change in internal control over financial reporting during the quarter.
Important facts for investors to verify
- Whether and when the FDA accepts, reviews and acts on the Iomab-B BLA, and whether it requests further studies or information.
- Full SIERRA results and regulatory interpretation, especially the distinction between the met primary endpoint, the unmet intent-to-treat overall-survival endpoint and exploratory analyses.
- Cash use against management’s stated runway, future clinical/manufacturing costs, and the availability and terms of additional financing.
- Potential dilution from the sales agreement and other capital raises; the filing does not state the remaining capacity available under the agreement.
- Readiness of manufacturing, isotope supply, commercial operations and reimbursement plans, as well as progress on Immedica’s regional application and the deferred license revenue.
- Clinical updates, timelines and safety findings for Actimab-A and Iomab-ACT, which remain investigational programs.