Actinium Pharmaceuticals, Inc. — Q1 2021 Form 10-Q
Reporting period: Three months ended March 31, 2021. The unaudited statements are prepared under U.S. GAAP. Actinium is a clinical-stage biopharmaceutical company developing antibody radiation-conjugates (ARCs); it had no approved products or commercial product sales.
Financial results and liquidity
Amounts below are in millions, except per-share data and where noted.
| Metric | Q1 2021 | Q1 2020 |
|---|---|---|
| Commercial revenue | $0 | $0 |
| Other collaboration revenue | $0.622 | $0 |
| Research and development expense, net | $4.276 | $4.151 |
| General and administrative expense | $1.718 | $1.532 |
| Total operating expenses | $5.994 | $5.683 |
| Operating loss | $(5.372) | $(5.683) |
| Net loss | $(5.320) | $(5.670) |
| Basic and diluted loss per share | $(0.29) | $(0.98) |
| Net cash used in operating activities | $(5.642) | $(5.854) |
| Net cash provided by financing activities | $14.340 | $2.542 |
- Other revenue came from nonrefundable payments under a third-party research collaboration; it was recognized as research services were provided. It was not product sales.
- At March 31, cash and cash equivalents were $72.253 million; including restricted cash, cash, cash equivalents and restricted cash totaled $72.693 million. Total current assets were $73.747 million and current liabilities were $4.164 million.
- Total liabilities were $4.361 million, principally accounts payable and accrued expenses of $3.727 million and lease liabilities. The filing reports no material off-balance-sheet arrangements and no conventional borrowings outstanding at quarter-end.
- Management stated existing resources were expected to fund planned operations for more than 12 months following the May 14, 2021 filing date. This is not a guarantee; the company expects continuing losses and may need additional capital.
- Operating cash use decreased by $0.212 million year over year, while the net loss narrowed by $0.350 million. The company raised $14.361 million net from common-stock sales in Q1, versus $2.674 million in Q1 2020.
Material changes and business developments
- Research and development expense increased $0.125 million, mainly from added employee compensation, partly offset by lower CD45 program expenses. General and administrative expense rose $0.186 million, primarily due to higher professional fees. Collaboration revenue and higher interest income helped reduce the net loss.
- Under its JonesTrading Capital on Demand agreement, the company sold 1.7 million shares in Q1 for $14.8 million gross and $14.4 million net. After quarter-end, it sold another 0.9 million shares for $7.2 million net. Common shares outstanding were 19,245,638 at March 31 and 20,194,869 at May 14, 2021.
- Accumulated deficit was $236.294 million at March 31, compared with $230.974 million at December 31, 2020. Stockholders’ equity was $70.736 million, up from $61.319 million.
- Actinium announced a collaborative research agreement with Astellas in January 2021 to explore AWE-platform theranostics for solid tumors. In March, it reported preclinical work on an Ac-225 CD45 ARC. These are development activities, not approved products.
Outlook, clinical programs and risks
- Iomab-B / SIERRA: The pivotal Phase 3 trial for older patients with relapsed or refractory AML was active at 24 sites and had reached 75% enrollment (113 of a planned 150 patients) by Q3 2020. After reviewing unblinded data at a single ad hoc interim analysis, the independent Data Monitoring Committee recommended continuing to full enrollment; the company said it did not receive the unblinded efficacy results. Management expected to complete enrollment and report topline data it believed could support a BLA, but the filing gives no specific completion date.
- Company-reported interim safety and feasibility data for the first 113 patients included BMTs for all 49 study-arm patients receiving a therapeutic Iomab-B dose and all 30 therapeutic-dose crossover patients. The reported 100-day transplant-related mortality was 4% (2/45) in the study arm versus 20% (2/10) among control-arm patients who received BMT after salvage therapy. These are interim figures, not the final primary-endpoint analysis; the filing cautions that preliminary data may change.
- Iomab-ACT: The company reported that the first patient in an MSKCC CAR-T collaboration was dosed in March 2021 and expected proof-of-concept data in the second half of 2021. A separate UC Davis gene-therapy collaboration was also described.
- Actimab-A: In an investigator-initiated Actimab-A plus CLAG-M study, the company reported CR or CRi in 10 of 15 patients across dose cohorts and said dose escalation was continuing. In the Actimab-A plus venetoclax trial, early data from the first dose cohort showed responses in 2 of 3 patients. These small, early-stage cohorts do not establish efficacy.
- COVID-19: Management reported no significant clinical-development or drug-production disruption to date and no financial impact to date, while warning that renewed restrictions, healthcare-system pressures, supply disruption or market volatility could delay trials or hinder access to capital.
- Principal risks: The company has a history of losses, no commercial product revenue, and dependence on future financing and successful clinical development—particularly SIERRA and Iomab-B. Other material risks include clinical-trial failure or delay, regulatory approval uncertainty, reliance on third-party manufacturers and isotope suppliers (including annual renewal of the DOE Ac-225 supply agreement), patient enrollment, safety, competition, intellectual-property limitations, and potential dilution from further equity sales.
- The company reported effective disclosure controls as of March 31, 2021, no material changes in internal control over financial reporting during the quarter, and no legal proceedings reported in this filing. It disclosed a $1 million payment due to FHCRC upon FDA approval of the first drug using the licensed BC8 antibody, plus 2% royalties on commercial net sales.
Important facts for investors to verify
- SIERRA final enrollment, endpoint results, safety data, and whether the data support a BLA filing.
- Cash runway assumptions, quarterly operating cash burn, and the pace and terms of future ATM share sales and resulting dilution.
- Whether collaboration revenue recurs, and the timing and funding of planned trials and R&D expansion.
- Clinical progress and final results for Iomab-ACT and Actimab-A combinations; distinguish company-reported interim findings from complete, independently assessed data.
- Continuity of clinical manufacturing and isotope supply, including renewal and capacity of the Ac-225 supply arrangement.
- Any COVID-19-related changes to trial enrollment, timelines, costs, or financing access.