Actinium Pharmaceuticals, Inc. — 2019 Form 10-K Summary
Reporting period: Fiscal year ended December 31, 2019; filed May 8, 2020. This is an annual report, not a standalone fourth-quarter report. Actinium is a clinical-stage biopharmaceutical company developing antibody radiation-conjugates (ARCs); it reported no commercial product revenue.
Financial results and liquidity
| Metric | 2019 | 2018 |
|---|---|---|
| Revenue | $0 | $0 |
| Research and development expense | $16.55 million | $17.09 million |
| General and administrative expense | $5.52 million | $6.73 million |
| Operating loss | $22.07 million | $23.83 million |
| Net loss | $21.90 million | $23.65 million |
| Basic and diluted loss per share | $0.15 | $0.22 |
| Cash used in operating activities | $21.46 million | $20.57 million |
| Cash and cash equivalents at year-end | $9.25 million | $13.67 million |
Net loss narrowed by $1.75 million, mainly because of lower R&D and G&A expenses. Operating cash use increased by $0.89 million, primarily reflecting payment timing. No operating margin is meaningful because the company had no revenue.
At December 31, 2019, total assets were $11.67 million, total liabilities $6.03 million, and stockholders’ equity $5.64 million. Current assets were $10.09 million versus current liabilities of $5.34 million. Liabilities included a $0.38 million insurance-premium note payable and lease obligations; the filing does not present conventional funded borrowings as a material financing source. Cash, cash equivalents, and restricted cash totaled $9.69 million.
Accumulated deficit was $208.76 million. The company funded operations principally through equity and warrant offerings. In April 2020, it raised $31.6 million gross ($29.1 million net) through an offering of 210.8 million shares and/or pre-funded warrants. Management expected resources to fund planned operations for more than 12 months from the filing date. This subsequent financing substantially increased potential share dilution.
Business developments and material changes
- Iomab-B: The lead CD45-targeted conditioning candidate was in the randomized pivotal Phase 3 SIERRA trial for patients age 55 or older with relapsed or refractory AML before allogeneic bone marrow transplant (BMT). The planned enrollment was 150; the company reported 50% enrollment in July 2019.
- CD33 pipeline: Actinium was advancing lintuzumab–Ac-225 candidates for targeted conditioning and therapeutic use, including Actimab-MDS, combination studies in AML, and Actimab-M for multiple myeloma.
- Iomab-ACT: The company was pursuing lower-dose CD45 conditioning for cell and gene therapies. A University of California Davis collaboration was testing Iomab-ACT in a Phase 1/2 HIV-related lymphoma gene-therapy study.
- 2019 R&D expense decreased 3% and G&A decreased 18% versus 2018. Weighted-average shares rose to 149.3 million from 106.0 million; year-end common shares outstanding increased to 164.7 million from 115.7 million.
Outlook, management commentary, risks, and unusual items
- Management expected SIERRA enrollment completion and topline results that could support a U.S. biologics license application (BLA) in 2021. In April 2020, it also said it intended to pursue an ad hoc interim analysis that might yield primary-endpoint topline data in late 2020 and permit early trial termination if positive. These were expectations, not reported outcomes.
- Safety and feasibility findings presented in February 2020 covered the first 75 SIERRA patients, not final trial results. Among study-arm patients receiving therapeutic Iomab-B, 31 of 31 proceeded to BMT; the filing also reported engraftment in all such patients and 6% 100-day transplant-related mortality. The small, interim dataset does not establish trial success or regulatory approval.
- COVID-19 had not caused a reported financial impact or significant clinical-development disruption as of the filing, but management warned of possible enrollment, site, supply, manufacturing, regulatory, and capital-market delays. The pandemic also contributed to the delayed 10-K filing and could delay later reports.
- On April 29, 2020, NYSE American notified the company of a low-share-price listing deficiency. It required a reverse split or sustained price improvement by October 29, 2020 to support continued listing. Stockholders had authorized a reverse split of up to 1-for-75, subject to board action and other requirements.
- Key risks include continued losses and dependence on additional financing; clinical-trial failure or delay; regulatory uncertainty; reliance on third-party manufacturing and isotope suppliers; competition; potential reimbursement limits; and patent challenges. The company reported no material legal proceedings and no off-balance-sheet arrangements.
- The auditor issued an unqualified opinion on the financial statements. Management concluded disclosure controls and internal control over financial reporting were effective at December 31, 2019; the auditor did not provide an internal-control attestation.
Important facts for investors to verify
- Current SIERRA enrollment, interim or final results, statistical analysis, safety profile, and regulatory plans for Iomab-B.
- Actual cash runway and spending after the April 2020 financing, including net proceeds, subsequent cash use, and potential warrant or pre-funded-warrant dilution.
- NYSE American compliance status and whether a reverse split or sustained share-price improvement occurred by the stated deadline.
- Progress and results for the CD33 trials and Iomab-ACT, including whether planned timelines were met.
- Availability and continuity of I-131, Ac-225, contract manufacturing, and clinical-site capacity, particularly amid pandemic-related disruptions.