ATNM
RadTechActinium Pharmaceuticals, Inc.
Chart
At a glance
No thesis note yet.
The call
ThesisWe see limited upside: at $1.18 the shares sit 99% above our $0.01 intrinsic estimate.
ValuationThe DCF is not meaningful here — its terminal year is still cash-flow-negative — so we anchor on the peer EV/EBITDA multiple at $0.01 rather than the raw intrinsic number.
What's priced inAt $1.18, the tape is discounting a contraction our model does not model — the tape is more bearish than our floor.
LevelsHistory is too thin for a scenario band, so we frame value on the $0.01 point estimate and would look to accumulate below $0.01 (~25% margin of safety).
Risks to ratingKey risks to the rating: the estimate rests on unreviewed tier-default assumptions, not an owner-reviewed model.
Bottom lineBottom line: sell into strength; downside to our $0.01 estimate. Low-conviction call.
Model-derived synthesis of the computed valuation — not investment advice.
Price & volume signals
Technical signals from price history, for your own read of market timing. These never affect the Estimated Price — they sit apart from the valuation by design.
· Only 47 bars — the 50/200-day averages need more history.
Drafted from official evidence. It does not change the Estimated Price until you approve it.
Official filings (8-K, 10-Q, 10-K) show a clinical-stage, zero-revenue radiopharmaceutical company with no approved products, five consecutive annual net losses, a $33.9M 2025 net loss, only ~$42.1M cash (>12-month runway), and a NYSE American delisting notice due to stockholders' equity (~$2.3M) below the $4.0M minimum. Management explicitly continues to expect net losses. Therefore, the current curve's positive revenue ramp and recovery to an 18% EBITDA margin by Year 10 are not supported. Revenue growth is set to 0% throughout; EBITDA margins remain deeply negative, following the current curve's negative path through Year 9 and holding the Year 9 level in Year 10 instead of the unsupported +18%. Auto-corrections: EBITDA margin Y1: -400.8222 out of [-1, 0.6] — clamped to -1. EBITDA margin Y2: -356.2664 out of [-1, 0.6] — clamped to -1. EBITDA margin Y3: -311.7106 out of [-1, 0.6] — clamped to -1. EBITDA margin Y4: -267.1548 out of [-1, 0.6] — clamped to -1. EBITDA margin Y5: -222.599 out of [-1, 0.6] — clamped to -1. EBITDA margin Y6: -178.0432 out of [-1, 0.6] — clamped to -1. EBITDA margin Y7: -133.4874 out of [-1, 0.6] — clamped to -1. EBITDA margin Y8: -88.9316 out of [-1, 0.6] — clamped to -1. EBITDA margin Y9: -44.3758 out of [-1, 0.6] — clamped to -1. EBITDA margin Y10: -44.3758 out of [-1, 0.6] — clamped to -1.
| Y1 FY2026 | Y2 FY2027 | Y3 FY2028 | Y4 FY2029 | Y5 FY2030 | Y6 FY2031 | Y7 FY2032 | Y8 FY2033 | Y9 FY2034 | Y10 FY2035 | |
|---|---|---|---|---|---|---|---|---|---|---|
| Revenue growth | 0.00% was 0.00% | 0.00% was 0.28% -0.3pp | 0.00% was 0.56% -0.6pp | 0.00% was 0.83% -0.8pp | 0.00% was 1.11% -1.1pp | 0.00% was 1.39% -1.4pp | 0.00% was 1.67% -1.7pp | 0.00% was 1.94% -1.9pp | 0.00% was 2.22% -2.2pp | 0.00% was 2.50% -2.5pp |
| EBITDA margin | -100.00% was -40082.22% +39982.2pp | -100.00% was -35626.64% +35526.6pp | -100.00% was -31171.06% +31071.1pp | -100.00% was -26715.48% +26615.5pp | -100.00% was -22259.90% +22159.9pp | -100.00% was -17804.32% +17704.3pp | -100.00% was -13348.74% +13248.7pp | -100.00% was -8893.16% +8793.2pp | -100.00% was -4437.58% +4337.6pp | -100.00% was 18.00% -118.0pp |
- Y1 · FY2026 — 8-K delisting risk and 10-Q zero-revenue confirm no revenue; margin follows current curve and 10-K loss trend.
- Y2 · FY2027 — 10-K: no approved products or revenue; margin improves per current curve but remains negative.
- Y3 · FY2028 — 10-Q: manufacturing facility for clinical supply only; no revenue; margin negative.
- Y4 · FY2029 — Actimab-A initial data expected 2H:2026/1H:2027; still no revenue; margin reverts to current curve.
- Y5 · FY2030 — 10-K: FDA demands randomized Iomab-B trial; no revenue; margin negative.
- Y6 · FY2031 — Management seeks partners but none signed; revenue stays zero; margin per current curve.
- Y7 · FY2032 — No new evidence; revert to current curve's margin path.
- Y8 · FY2033 — 10-K hedge language and delisting deadline Nov 2027; no revenue; margin negative.
- Y9 · FY2034 — Forward-looking statements expect continued net losses; margin remains negative per current curve.
- Y10 · FY2035 — Holding margin at Y9 level; no evidence supports recovery to 18%; growth at 0 ≤4% cap.
D&A, working capital use disclosed defaults rather than this company's own history — its ingested statements do not carry enough years. The rest of the cash-conversion path is derived from its own filings.
Beta 1.18: Drugs (Biotechnology) unlevered 1.18 (Damodaran, Global, Jan 2026) relevered at this company's own market D/E 0.0%.
Estimate shown is the peer P/S-implied price, not the DCF: the discounted-cash-flow model is not meaningful for this name (negative terminal-year cash flow). Value it on relative multiples and Level-3 assumptions, not the raw DCF.
The DCF path is discarded— its final-year cash flow is negative, so it isn't meaningful. The two struck figures are shown for transparency only; they do not feed the 0.01 estimate.
No reliability rule firing — Level 1 passes through.
Interest expense not ingested — coverage not computed.
Serviceability lens (EBIT ÷ interest) — separate from the WACC and the leverage haircut; never moves the Estimated Price.
Not meaningful — negative terminal-year cash flow; a single-scenario DCF has broken down here.
Shown side by side, never averaged. Headline uses the DCF, with the peer multiple as fallback when the DCF is invalid.
- · No debt on the balance sheet — cost of debt is immaterial to the WACC.
- · Year-10 FCF is still negative after the full explicit period — terminal value is unreliable.
- · DCF not meaningful (negative terminal-year cash flow) — headline falls back to the peer P/S-implied price.
The estimate sits -99% below the market, though the lenses conflict or the data is thin — a low-confidence read, lean on your own judgement.
A reading of the numbers already computed — not a new estimate. It never overrides a method, rule, or approval gate.
Not meaningful — the DCF's final year is still cash-flow-negative, so it can't anchor value here.
Peer-implied $0.01 — -99% vs price; DCF sits -35793% vs peer.
DCF not meaningful — a scenario band on a broken DCF would mislead.
Interest coverage not computable — no interest figure ingested.
No reliability rule firing — the Level-1 DCF passes through un-haircut.
Price above its moving averages. Timing only — never part of the value read.
- ·DCF is not meaningful (negative terminal-year cash flow); the headline leans on the peer multiple instead.
- ·Peer multiple implies $0.01 (-99% vs price) — reads rich.
- ·Only one value lens is available — the read rests on a single method, uncorroborated.
- ·No scenario band — history is too thin to gauge how assumption-sensitive the estimate is.
Fundamentals
Position
No open position. Record a trade on the Portfolio tab and it flows into this card.
Status
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Actinium is a clinical-stage, zero-revenue radiopharmaceutical company, so the standard operating metrics (leverage, book-to-bill, customer capex) simply do not apply: total debt is zero, there is no backlog, and TTM revenue of $90K is negligible against a $33.9M net loss and $36.1M negative EBITDA. With no debt, net leverage is not a concern and the distress-multiple rules are not triggered — the balance sheet is clean on a gross basis.
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The real story is runway and survival. Cash of $36.5M at 6/30/26 against roughly $5.9M/quarter of operating burn implies about six quarters, i.e. ~18 months of funding — inside the 24-month threshold in the rules and ahead of the Actimab-A basket readout (2H:2026/1H:2027), the Iomab-ACT SCD data, and the New York cGMP plant coming online in 2H:2026. Any acceleration of spend for registrational work or a partnership that slips would shorten that window, and management itself uses hedged language and is actively seeking partners or divestitures for the hematology assets. Layered on top is a genuine listing problem: NYSE American has deemed the company non-compliant with the $4.0M minimum stockholders' equity standard (equity ~$2.3M at 3/31/26 after five consecutive loss years), remediation was due 6/26/26 and compliance must be regained by 11/27/27; shares trade under the '.BC' indicator and failure would risk delisting. The $35M Immedica deferred revenue is contingent on an EU Iomab-B outcome, not a near-term cash source, and the FDA's demand for a new randomized head-to-head Iomab-B trial plus dose optimization makes the registrational path longer and more expensive. Net: a clean-but-thin, pre-revenue name whose value hinges on financing and partnership execution rather than operations.
Pre-revenue radiopharma with cash of $36.5M at 6/30/26 against ~$5.9M/quarter operating burn implies roughly 18 months of runway — under the 24-month threshold — and it must span the Actimab-A basket readout (2H:2026/1H:2027), Iomab-ACT SCD data, and the 2H:2026 cGMP plant. Burn will likely rise if registrational trials are funded, and management is candid about needing partners or additional capital; a financing is effectively required before the runway runs out.
elevated · rule-runway
New EDGAR filings detected and ingested: an 8-K delisting-risk notification (NYSE American non-compliance with the $4.0M minimum stockholders' equity standard; equity ~$2.3M at 3/31/26; remediation plan due 6/26/26, compliance deadline 11/27/27, trading under '.BC'), the Q1 2026 10-Q (net loss improved to $5.5M on cost controls), the 10-K (2025 net loss $33.9M, accumulated deficit $409.7M), and a prior 10-Q ($53.4M cash at 9/30/25 on $19.3M nine-month burn). No guidance, backlog, capex, or capital-allocation detail was provided in the 8-K.
info · rule-filing
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Synthesized by deepseek-v4-flash over already-extracted filing facts, trajectory stats, and computed flags. Interpretation only — it moves no valuation number.
Filings & extraction
- 8-KAug 14, 2026Item 3.01,7.01,9.01Source ↗
Actinium Pharmaceuticals disclosed that NYSE Regulation accepted its compliance plan following a May 27, 2026 delisting notice for failure to meet continued listing standards. The company now has until November 27, 2027 to regain compliance, with its stock continuing to trade subject to periodic review. While this removes the immediate delisting threat, the company faces ongoing risk of delisting if it fails to make satisfactory progress or meet other listing requirements. The filing provides no financial or operational updates, leaving the company's underlying performance and capital position unaddressed.
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MD&A highlights- ·On May 27, 2026, the Company received notice from NYSE American that it was not in compliance with Sections 1003(a)(ii) and (iii) of the NYSE American Company Guide.
- ·On June 18, 2026, the Company submitted a compliance plan to NYSE American.
- ·On August 12, 2026, NYSE Regulation accepted the compliance plan and granted a plan period through November 27, 2027.
- ·During the Plan Period, the Company's common stock will continue to be listed and traded on NYSE American, subject to compliance with other continued listing requirements and periodic review.
Key risks- ·The Company can provide no assurance that it will make progress that NYSE Regulation determines to be satisfactory.
- ·The Company can provide no assurance that it will regain compliance during the Plan Period.
- ·Subsequent developments may adversely affect the Company's ability to regain compliance or to remain in compliance with other NYSE American continued listing standards.
- ·If the Company does not regain compliance by the end of the Plan Period or does not make progress consistent with the compliance plan, NYSE Regulation may initiate delisting proceedings.
Forward-looking · richest in 10-KsOutlook / toneNYSE Regulation has reviewed and accepted the Company's compliance plan and granted a plan period through November 27, 2027, during which the Company's common stock will continue to be listed and traded, subject to the Company's compliance with the other continued listing requirements of NYSE American and periodic review by NYSE Regulation of the Company's compliance with the initiatives outlined in the compliance plan. The Company can provide no assurance that it will make progress that NYSE Regulation determines to be satisfactory, that it will regain compliance during the Plan Period, or that subsequent developments will not adversely affect its ability to do so or to remain in compliance with other NYSE American continued listing standards.
Extracted by deepseek-v4-flash · Aug 14, 2026
- 10-QAug 07, 2026Source ↗
Actinium Pharmaceuticals reported net income of $27.9 million in Q2 2026, driven entirely by recognition of a $35 million deferred license payment from Immedica. The underlying business remains a clinical-stage radiopharma with cash of $36.5 million (down from $48.0 million at 2025 year-end) and ongoing operating cash burn. Pipeline focus is on ATNM-400 (solid tumors) with multiple preclinical data presentations, and Actimab-A across AML/MDS and MDSC-modulation in solid tumors. Management expects multiple clinical data readouts between 4Q:2026 and 2027 and is seeking a partner to conduct the Phase 2/3 trial of Actimab-A + CLAG-M. Capital commitments are modest ($0.9 million remaining for manufacturing facility), but litigation risk from shareholder suits and reliance on partnerships are notable overhangs.
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MD&A highlights- ·We are a clinical-stage biopharmaceutical company pioneering the development of targeted radiotherapies to address significant unmet medical needs in oncology.
- ·We expect to report data from ongoing company- and investigator-sponsored clinical studies for ATNM-400, Actimab-A for MDSC’s and Iomab-ACT in 4Q:2026 and over the course of 2027.
- ·We expect to report initial data from the Actimab-A Phase 1b basket trial in 2H:2026 or 1H:2027.
- ·We have discussed with the Food and Drug Administration (FDA) and believe we are aligned on a Phase 2/3 trial design to evaluate Actimab-A plus CLAG-M in R/R AML patients eligible for first or second salvage therapy. We are actively seeking a strategic partner to execute this trial.
- ·The Company recognized the previously deferred $35 million upfront payment as revenue in June 2026 after concluding Immedica’s right to assert a claim had expired.
Key risks- ·Actual results may differ materially depending on a variety of factors, many of which are not within our control, including economic conditions, competition from much larger competitors, technological advances and failure to successfully develop business relationships.
- ·The Company and other Defendants intend to defend vigorously against the securities class action and derivative claims, however, there can be no assurances as to the outcome.
- ·Immedica notified the Company that it would not pursue regulatory approval of Iomab-B in the licensed territories.
- ·Since its inception, the Company has generated net operating losses in substantially all periods and has accumulated significant federal and state net operating loss carryforwards.
Forward-looking · richest in 10-KsOutlook / toneOur mission is to transform cancer treatment by delivering innovative, high-value, radioconjugates that maximize therapeutic efficacy while minimizing toxicity to healthy tissue. We expect to report data from ongoing company- and investigator-sponsored clinical studies for ATNM-400, Actimab-A for MDSC’s and Iomab-ACT in 4Q:2026 and over the course of 2027, and initial data from the Actimab-A Phase 1b basket trial in 2H:2026 or 1H:2027. We believe ATNM-400 is positioned to address large, treatment-resistant patient populations, with an estimated addressable population of well over 350,000 patients per year in the United States across prostate cancer, NSCLC and breast cancer.
Strategic priorities- ·We are developing ATNM-400 as a potential pan-cancer, biology-driven therapy - alone or in combination with standard-of-care agents - for large, treatment resistant-solid tumor populations across prostate, NSCLC, breast cancer and potentially other sizable cancer indications.
- ·Actimab-A is designed to enhance checkpoint inhibitor efficacy by depleting immunosuppressive CD33+ myeloid-derived suppressor cells (MDSCs) in the tumor microenvironment, positioning it as a differentiated immunomodulatory approach.
- ·We are developing Actimab-A as a mutation-agnostic backbone therapy for AML and high-risk MDS, including combinations with menin inhibitors, FLT3 inhibitors, and hypomethylating agents.
- ·We are actively seeking a strategic partner to execute the Actimab-A + CLAG-M Phase 2/3 trial in R/R AML.
- ·The programs are supported by our Cooperative Research and Development Agreement (CRADA) with the NCI, which enables cost-effective clinical development while retaining commercial rights to Actimab-A.
Capex / expansionAs of June 30, 2026, the Company had contractual commitments of approximately $1.5 million related to the equipment purchase and construction of its newly leased manufacturing facility. Of this amount, approximately $0.6 million had been incurred through June 30, 2026, with the remaining $0.9 million anticipated to be incurred during the second half of 2026.
Extracted by deepseek-v4-flash · Aug 07, 2026
- 8-KMay 29, 2026Item 3.01,7.01,9.01Source ↗
This 8-K is a delisting-risk notification, not a financial update. Actinium disclosed that NYSE American deemed it non-compliant with the $4.0 million minimum stockholders' equity continued-listing standard; at March 31, 2026, its equity was only about $2.3 million, following net losses in five consecutive fiscal years. The company must file a remediation plan by June 26, 2026, with a compliance deadline of November 27, 2027; while trading continues under the '.BC' indicator, failure to regain compliance could trigger delisting. The filing also references a May 29 press release updating the ATNM-400 development program, but the release text is not included in the excerpt. No guidance, backlog, debt, capex, or capital-allocation details were provided.
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MD&A highlights- ·On May 27, 2026, the Company received a NYSE American notice stating it is not in compliance with Section 1003(a)(ii) of the NYSE American Company Guide, which requires stockholders' equity of $4.0 million or more if losses from continuing operations and/or net losses in three of four most recent fiscal years.
- ·As of March 31, 2026, the Company reported stockholders' equity of approximately $2.3 million and had net losses in its last five fiscal years ended December 31, 2025.
- ·The Company must submit a plan by June 26, 2026 advising actions to regain compliance by November 27, 2027; if accepted, it will be subject to periodic reviews and quarterly monitoring.
- ·The Notice has no immediate effect on listing or trading; ATNM continues to trade on NYSE American with a ".BC" indicator denoting below-compliance status.
- ·In connection with non-compliance with Sections 1003(a)(ii) and (iii), delisting proceedings may commence if the plan is not submitted/accepted or compliance is not achieved by the Plan Period Deadline.
Key risks- ·Failure to submit an acceptable plan by June 26, 2026, or to regain compliance with NYSE American continued listing standards by November 27, 2027, could result in delisting proceedings.
- ·Even if the plan is accepted, the Company must make consistent progress under the plan; failure to do so could cause NYSE American staff to initiate delisting proceedings.
- ·There can be no assurance that the Company will be able to regain compliance, that NYSE American will accept its plan, that it can comply with the plan terms, or that it can maintain the listing of its common stock.
- ·The Company's stockholders' equity of approximately $2.3 million at March 31, 2026 is below the $4.0 million continued listing threshold, and the Company has reported net losses in its last five fiscal years.
Forward-looking · richest in 10-KsOutlook / toneThe Notice has no immediate effect on the listing or trading of the Company's common stock, which will continue to trade on NYSE American under the symbol 'ATNM,' subject to the Company's compliance with the other continued listing requirements of NYSE American, and will continue to trade with a '.BC' indicator to denote that the Company is below compliance. The Company intends to submit a plan to NYSE American within the required timeframe. There can be no assurance that the Company will be able to regain compliance with the applicable continued listing standards, that the Company will submit a plan that is accepted by NYSE American, that the Company will be able to comply with the terms of any accepted plan, or that the Company will be able to maintain the listing of its common stock on NYSE American.
Strategic priorities- ·Submit a plan to NYSE American within the required timeframe advising of actions taken or to be taken to regain compliance with continued listing standards.
Risk-factor changesNewly disclosed risk: the Company received a NYSE American notice of non-compliance with continued listing standards under Sections 1003(a)(ii) and (iii), requiring stockholders' equity of at least $4.0 million; as of March 31, 2026, stockholders' equity was approximately $2.3 million, and the Company had net losses in its last five fiscal years. The Company must submit a compliance plan by June 26, 2026 and regain compliance by November 27, 2027 to avoid potential delisting.
Extracted by deepseek-v4-flash · Aug 01, 2026
- 10-QMay 08, 2026Source ↗
Actinium Pharmaceuticals is a clinical-stage, zero-revenue biotech focused on targeted radiotherapies. Q1 2026 net loss improved dramatically to $5.5M from $15.9M, largely due to a one-time $8.7M stock-comp charge in Q1 2025 and disciplined cost controls (headcount reduced ~14% in 2025). Cash at $42.1M supports a >12-month runway given quarterly operating cash burn of ~$5.9M. Pipeline remains early; key near-term catalysts are initial Actimab-A basket trial data (2H:2026/1H:2027) and completion of the manufacturing facility (2H:2026). The company is actively seeking partners to advance Iomab-B and Actimab-A pivotal trials, while facing an overhang from securities and derivative litigation related to the SIERRA trial. Balance sheet is clean with no debt, but $35M of deferred revenue from the Immedica license will only convert upon EU regulatory outcome for Iomab-B.
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MD&A highlights- ·Revenue was $0 for the three months ended March 31, 2026 and 2025; net loss decreased to $5.5 million from $15.9 million year-over-year.
- ·Research and development expense, net of reimbursements, decreased to $4.2 million from $7.7 million, driven by lower non-cash stock-based compensation, lower CRO services, and lower headcount.
- ·General and administrative expense decreased to $1.7 million from $8.9 million, primarily due to the absence of the March 2025 stock option cancellation charge of $8.7 million.
- ·Long-term deferred license revenue remained $35 million at March 31, 2026, to be recognized upon EU regulatory approval of Iomab-B or definitive feedback that Iomab-B will not receive approval in the European Union.
- ·As of the date of filing this report, we expect that our existing resources will be sufficient to fund our planned operations for more than 12 months following the date of this report.
GuidanceAs of the date of filing this report, we expect that our existing resources will be sufficient to fund our planned operations for more than 12 months following the date of this report.
Debt / leverageThe condensed consolidated balance sheet shows no short-term or long-term debt; total liabilities consist of accounts payable and accrued expenses of $6.6 million, operating and finance lease liabilities, and $35.0 million of long-term deferred license revenue.
Key risks- ·Risks associated with completing preclinical studies and clinical trials, receiving regulatory approvals for product candidates, development by competitors, dependence on key personnel, protection of proprietary technology, compliance with government regulations, and the ability to secure additional capital to fund operations.
- ·The consequences of ongoing geopolitical conflicts (Russia/Ukraine, Middle East), related sanctions and countermeasures, and rising global inflation could adversely impact macroeconomic conditions and increase market volatility, which may adversely affect business and operations.
- ·U.S. federal government shutdowns, such as the shutdown that began October 1, 2025 and ended November 12, 2025, have curtailed operations of key agencies such as the FDA and NIH; future shutdowns may delay or disrupt clinical development under the CRADA or regulatory interactions.
- ·A putative securities class action and related derivative complaints allege material misrepresentations and omissions concerning the Iomab-B Phase 3 SIERRA trial; the Company intends to defend vigorously but there can be no assurances as to the outcome.
Forward-looking · richest in 10-KsOutlook / toneThe Company states: 'We are currently completing construction of a radiopharmaceutical manufacturing facility designed to manufacture Ac-225-based final drug products for clinical supply. The facility, expected to be operational in 2H:2026,' and 'We expect to report initial data from this trial in 2H:2026 or 1H:2027.' Additionally, 'As of the date of filing this report, we expect that our existing resources will be sufficient to fund our planned operations for more than 12 months following the date of this report.'
Strategic priorities- ·Advancing ATNM-400, a first-in-class Ac-225 antibody radioconjugate targeting a novel non-PSMA antigen, as lead solid tumor program across prostate, non-small cell lung cancer, and breast cancer.
- ·Conducting a Phase 1b basket trial of Actimab-A in combination with pembrolizumab or nivolumab in HNSCC, NSCLC, glioblastoma, and MSI-high colorectal cancer, with initial data expected in 2H:2026 or 1H:2027.
- ·Actively seeking a strategic partner to execute the Phase 2/3 trial of Actimab-A plus CLAG-M in R/R AML.
- ·Actively seeking a strategic partner to advance Iomab-B through pivotal development and commercialization.
- ·Completing construction of the radiopharmaceutical manufacturing facility expected operational in 2H:2026.
Capex / expansionAs of March 31, 2026, the Company had contractual commitments of approximately $1.5 million related to the construction of its modular removable manufacturing space in its newly leased manufacturing space, with $1.4 million expected to be incurred in 2026. The Company is completing construction of a cGMP radiopharmaceutical manufacturing facility in New York, expected to be operational in 2H:2026.
Extracted by deepseek-v4-flash · Aug 01, 2026
- 10-KMar 30, 2026Source ↗
Actinium is a clinical-stage radiopharmaceutical company with no approved products or revenue; it reported a 2025 net loss of $33.9M and an accumulated deficit of $409.7M, with existing resources expected to fund operations for "more than 12 months" from filing. The pipeline splits between early solid-tumor assets (ATNM-400 is still preclinical; Actimab-A MDSC basket data due 2H:2026) and late-stage hematology assets (Iomab-B, Actimab-A) that are Phase 2/3-ready but face an FDA demand for a new randomized head-to-head Iomab-B trial plus dose optimization before any BLA. Management is actively seeking partnerships to finance those registrational trials and signals a cautious, hedged outlook ("there can be no assurance," "significant uncertainty" around FDA policy), while directing capital to a New York cGMP plant expected online in 2H:2026. Key investor watchpoints are partnership execution, additional financing, regulatory/agency disruption, and pipeline data readouts.
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GuidanceNo formal financial guidance is provided. Management expects "to continue to operate at a net loss as we continue our research and development efforts" and believes existing resources "will be sufficient to fund our planned operations for more than 12 months" from the filing date. Clinical/operational timelines: Actimab-A basket trial initial data expected in 2H:2026; cGMP manufacturing facility expected operational in 2H:2026.
Key risks- ·Clinical-stage company with no revenue from commercial sales; net losses every year since inception (2025 net loss $33.9M, accumulated deficit $409.7M).
- ·If additional financing is not obtained, the company may be unable to continue or complete product development; existing resources expected to fund operations for only more than 12 months.
- ·Heavy dependence on unapproved candidates ATNM-400, Actimab-A, Iomab-ACT, and Iomab-B; FDA determined SIERRA trial alone inadequate for Iomab-B BLA and requires additional randomized head-to-head trial plus dose optimization trial.
- ·Regulatory and operational disruptions from FDA/government shutdowns, leadership changes, and proposed workforce reductions; Oct 1-Nov 12, 2025 shutdown expected to delay CRADA trials.
- ·Reliance on third-party manufacturers and isotope suppliers for Ac-225 and I-131; DOE supply contract renewed annually with no assurance of continuation.
- ·Intense competition from large pharma and clinical-stage radiopharmaceutical companies, and possible M&A-related competitive shifts.
- ·Key personnel dependence; February 2026 CFO resignation, Q2 2025 workforce optimization of ~14% headcount, and Q3 2024 ~20% headcount reduction.
Forward-looking · richest in 10-KsOutlook / toneManagement's tone is cautiously optimistic about the radiopharmaceutical market ("we believe the radiopharmaceutical field remains in its early stages") but heavily hedged on company-specific outcomes: forward-looking statements "cannot guarantee their accuracy," and the filing repeatedly uses "there can be no assurance" regarding approvals and commercialization. Management cites "significant uncertainty and risks associated with future FDA regulatory policies and actions," expects continued net losses, and is actively seeking partners for late-stage programs because it lacks resources to run required trials independently.
Strategic priorities- ·Rapidly advance ATNM-400 through clinical development across multiple solid tumor indications.
- ·Establish Actimab-A MDSC in combination with checkpoint inhibitors, with a planned basket trial across HNSCC, NSCLC, GBM, and MSI-high colorectal cancer.
- ·Execute strategic partnerships for late-stage hematology programs Actimab-A and Iomab-B.
- ·Build fully integrated cGMP manufacturing and end-to-end supply chain.
- ·Continue platform innovation and pipeline expansion through internal discovery and potential strategic acquisitions of complementary assets or technologies.
Capex / expansionConstruction of a cGMP radiopharmaceutical manufacturing facility in New York, expected to be operational in 2H:2026; designed for clinical-stage supply of Ac-225-based radioconjugates. Also pursuing proprietary cyclotron-based Ac-225 production technology, with management stating it will "opportunistically seek partnerships to manufacture Ac-225 utilizing our patented cyclotron production technology."
Capital allocationNo dividend or share repurchase program is discussed. Management intends to allocate capital to R&D, clinical trials, and the cGMP manufacturing facility, while keeping optionality for "potential strategic acquisitions of complementary assets or technologies" and for cyclotron Ac-225 manufacturing partnerships.
Risk-factor changesThe Risk Factors section emphasizes regulatory disruption: the Oct 1-Nov 12, 2025 federal government shutdown is expected to delay NCI CRADA trials, and the current administration's proposed FDA reductions in force create "significant uncertainty." It details the FDA's 2024 determination that SIERRA alone cannot support an Iomab-B BLA, requiring a new randomized head-to-head Phase 3 trial and a dose optimization study. It also discloses February 2026 CFO resignation and a Q2 2025 workforce optimization that reduced headcount by approximately 14%, plus expanded healthcare reform risk (One Big Beautiful Bill Act, MFN drug pricing models).
Extracted by deepseek-v4-flash · Aug 01, 2026
View all filings (+12) ▾Hide older / routine filings ▴
- 8-KJun 18, 2026Item 8.01routineSource ↗
Routine 8-K — kept for the record, not extracted.
- 8-KMar 26, 2026Item 5.07routineSource ↗
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- 8-KFeb 13, 2026Item 5.02routineSource ↗
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- 8-KNov 26, 2025Item 5.02,5.07routineSource ↗
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- 10-QNov 14, 2025Source ↗
Actinium is a development-stage radiopharmaceutical company with no product revenue, $53.4 million in cash at September 30, 2025, and $19.3 million of operating cash burn in the first nine months of 2025. Management has shifted focus to preclinical ATNM-400 as the lead program while seeking partners or divestitures for the hematology portfolio, including Iomab-B, which now requires a new randomized head-to-head trial after the FDA deemed SIERRA insufficient for a BLA. Non-cash stock option cancellation drove a notable year-over-year increase in G&A, though total operating expenses fell as R&D spending declined. Key near-term catalysts are initial proof-of-concept data from Iomab-ACT SCD and Actimab-A solid tumor trials in H1 2026, but the company will likely need additional capital and successful partnering to fund its broader pipeline ambitions.
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MD&A highlights- ·Total revenue was $90,000 (grant revenue) for the nine months ended September 30, 2025; no license revenue or collaborative arrangement revenue was recognized.
- ·Net loss was $5.1 million for Q3 2025 and $27.9 million for the nine months ended September 30, 2025, compared to $11.6 million and $31.6 million in the comparable 2024 periods.
- ·Cash and cash equivalents decreased to $53.4 million at September 30, 2025 from $72.9 million at December 31, 2024; net cash used in operating activities was $19.3 million in the first nine months of 2025.
- ·R&D expense declined to $16.8 million from $25.2 million year-over-year, while G&A expense increased to $13.1 million from $9.4 million, partly due to an $8.8 million stock option cancellation charge.
- ·FDA definitively advised that the SIERRA trial alone is not adequate to support a BLA for Iomab-B; an additional randomized head-to-head trial is required and the company is seeking a U.S. strategic partner.
- ·ATNM-400 was prioritized as the lead program, with preclinical data presented in prostate cancer and NSCLC and upcoming breast cancer data at SABCS on December 11, 2025.
- ·Iomab-ACT sickle cell disease trial at Columbia University and Actimab-A solid tumor program are expected to yield initial proof-of-concept data in the first half of 2026.
GuidanceNo financial guidance was provided. Operational guidance: initial proof-of-concept clinical data from the Iomab-ACT SCD trial and the Actimab-A solid tumor/PD-1 inhibitor trial are expected in the first half of 2026.
Debt / leverageNo external debt outstanding. The company has only lease liabilities (present value of $1.13 million for operating leases and $0.01 million for finance leases) and a $35.0 million long-term deferred license revenue contract liability.
Key risks- ·The FDA has advised that a randomized head-to-head trial demonstrating an overall survival benefit is necessary for Iomab-B approval; there can be no assurance such a trial will succeed.
- ·Ongoing securities class action and derivative shareholder lawsuits against the company and executives could result in substantial costs, diversion of management attention, and adverse outcomes.
- ·The company is actively seeking strategic partners for Iomab-B and may partner, divest, spin-out, or out-license hematology programs; failure to secure partners could delay or prevent development.
- ·ATNM-400 is in preclinical development; preclinical results may not be predictive of clinical outcomes, and product candidates face high risks of failure in clinical trials.
- ·The recent U.S. government shutdown (October 1 to November 12, 2025) is expected to cause delays to current and planned NCI CRADA trials.
- ·Novartis objected to Actinium's statements comparing ATNM-400 to Pluvicto; competitive or legal disputes could adversely affect the company's business.
Forward-looking · richest in 10-KsOutlook / toneManagement states ATNM-400 'has the potential to address multiple segments in these indications that exceed $20 billion in market potential' and intends to continue developing it 'with the goal of addressing these patient needs.' The company expects initial proof-of-concept data from the Iomab-ACT SCD trial and the Actimab-A solid tumor program in the first half of 2026. No financial outlook or revenue guidance was provided.
Strategic priorities- ·Prioritize ATNM-400 as the lead program and advance toward clinical development in mCRPC, NSCLC, and HR+/HER2- breast cancer.
- ·Complete a regulatory submission and initiate the Actimab-A basket trial combining with KEYTRUDA or OPDIVO in PD-1-inhibitor-naive solid tumors; initial proof-of-concept data expected in H1 2026.
- ·Continue Iomab-ACT SCD and CAR-T conditioning trials; initial SCD proof-of-concept data expected in H1 2026.
- ·Seek a strategic partner for Iomab-B to execute the FDA-required Phase 2/3 randomized trial and consider partnering, divesting, spinning out, or out-licensing non-solid tumor programs.
- ·Leverage the NCI CRADA for cost-efficient Actimab-A development and expand capabilities to include Ac-225 radioisotope production and in-house manufacturing.
Capex / expansionNo material capital expenditure plans were disclosed; property and equipment purchases were $0 in the nine months ended September 30, 2025.
Capital allocationThe company did not sell any shares under its ATM facility during the nine months ended September 30, 2025; the facility with JonesTrading and B. Riley allows for up to $200 million in aggregate sales. No dividends or share repurchases were disclosed.
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- 10-QAug 08, 2025unprocessedSource ↗
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- 10-QMay 09, 2025unprocessedSource ↗
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- 8-KMay 09, 2025Item 4.01,9.01unprocessedSource ↗
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- 10-KMar 31, 2025unprocessedSource ↗
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- 8-KNov 27, 2024Item 5.02,5.07routineSource ↗
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- 10-QNov 14, 2024unprocessedSource ↗
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- 8-KNov 05, 2024Item 5.02,8.01,9.01routineSource ↗
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Illustrative data where noted. Not investment advice.