Actinium Pharmaceuticals, Inc. quarterly report, Q3 FY2023

Actinium Pharmaceuticals, Inc. — Q3 2023 Form 10-Q

Reporting period: Three and nine months ended September 30, 2023. Filed November 2, 2023. The interim financial statements are unaudited. Actinium is a clinical-stage biopharmaceutical company developing targeted radiotherapies; it reported no commercial revenue.

Financial results and liquidity

Metric	Q3 2023	Q3 2022	Nine months 2023	Nine months 2022
Total revenue	$0	$45,000	$0	$1.03 million
Research and development expense, net	$11.62 million	$6.77 million	$30.55 million	$15.80 million
General and administrative expense	$2.73 million	$3.07 million	$11.03 million	$8.04 million
Net loss	$13.28 million	$9.47 million	$39.49 million	$22.37 million
Basic and diluted loss per share	$0.49	$0.38	$1.50	$0.94

Cash and cash equivalents were $82.98 million at September 30, 2023, versus $108.91 million at December 31, 2022. Cash, cash equivalents and restricted cash totaled $83.29 million.
Operating cash used was $39.85 million for the nine-month period; investing cash used was $0.15 million and financing cash provided was $13.68 million, principally from stock sales. Net cash and restricted cash declined $26.32 million.
The company raised $13.4 million net from common-stock sales during the first nine months. Shares outstanding were 27,413,441 as of November 1, 2023, up from 25,674,823 at year-end 2022.
Total liabilities were $45.36 million, including $35.0 million of deferred license revenue and $2.21 million of operating lease liabilities. The filing reports no borrowings; deferred license revenue is not conventional debt. Current assets were $85.60 million and current liabilities $8.67 million.
Management said existing resources were expected to fund planned operations for more than 12 months from filing; elsewhere it stated cash on hand was expected to fund operations through 2025. No revenue or profit guidance was provided.

Changes and management commentary

Year-to-date net loss increased $17.12 million year over year. R&D expense rose $14.75 million, chiefly due to Iomab-B CMC and BLA-enabling work and increased staffing. G&A expense rose $2.98 million, mainly from compensation, equity compensation, and professional fees.
Q3 R&D expense increased $4.85 million year over year. Management expects CMC expense to decrease in 2024 after planned production is completed for the BLA and initial commercial supply. Net interest income increased year over year, reflecting higher average interest rates.
Prior-year operating cash flow included Immedica’s $35 million upfront license payment. That amount remains deferred at September 30, 2023 and is expected to be recognized upon EU regulatory approval of Iomab-B. The Immedica agreement also provides for potential regulatory and commercial milestones and royalties in the mid-20% range.

Pipeline, outlook and material risks

Iomab-B: Management said the Phase 3 SIERRA trial met its primary endpoint of durable complete remission at six months (p<0.0001). The filing reports that the secondary overall-survival endpoint was not met in the intent-to-treat analysis, which management attributed to substantial crossover; exploratory analyses favored Iomab-B. The company was completing CMC work and targeted a BLA submission in the first half of 2024, subject to further FDA discussions. An early access program was anticipated after CMC activities; the European partner was preparing for a potential MAA filing.
Actimab-A: The company plans late-stage development, including a potential pivotal combination trial with NCI collaboration. The NCI expected to meet with FDA in Q1 2024 to finalize a potential trial design. Reported combination-study survival results are clinical-development data, not evidence of approval or commercial efficacy.
Other programs: Iomab-ACT is being studied as conditioning for cell therapies with MSKCC; management expected to provide program updates. Solid-tumor and other radiotherapeutic programs remain preclinical or early stage.
Key risks: Actinium has no approved products or commercial sales, a history of losses, and expects continued losses. It depends heavily on Iomab-B’s regulatory and commercial prospects, additional capital and equity financing, third-party clinical and manufacturing providers, and reliable isotope supply. FDA review, CMC completion, trial outcomes, reimbursement, commercialization execution, competition, intellectual-property protection, and possible adverse effects could delay or prevent development or sales. Further stock issuance may dilute investors.
The company reported no legal proceedings in the filing’s legal-proceedings section. It disclosed an ongoing dispute with a former employee involving alleged confidential-information misuse and noted a permanent injunction issued in April 2023. Disclosure controls were assessed as effective, with no material change in internal control over financial reporting reported.
After quarter-end, the board approved an amendment extending CEO Sandesh Seth’s employment term to February 21, 2027.

Important facts for investors to verify

Progress against the first-half 2024 Iomab-B BLA target, including FDA feedback, CMC completion, manufacturing readiness, and any filing or review milestones.
Whether cash runway assumptions through 2025 remain achievable, given operating cash use, planned development spending, and potential financing or dilution.
Final and regulator-reviewed SIERRA analyses, particularly the distinction between the met primary endpoint, the unmet intent-to-treat overall-survival endpoint, and exploratory crossover analyses.
Actimab-A trial design and timing under the NCI collaboration, plus the evidentiary status of reported subgroup and combination results.
Immedica’s EU regulatory progress and the conditions and timing for recognition of the $35 million deferred license revenue, potential milestones, and royalties.
Availability and qualification of third-party manufacturing capacity and I-131 and Ac-225 supply for clinical and potential commercial needs.