Actinium Pharmaceuticals, Inc.
For the period ended Mar 31, 2026. Filed May 8, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 8, 2026
ATNM$1.43+10.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-14.
0001213900-25-110979
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-08.
0001213900-26-053980
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 170 previous paragraphs and 133 current paragraphs.
28 unchanged; 17 reworded; 88 added; 119 removed; 6 previous and 0 current paragraphs rearranged.
Tables are not compared: 15 previous and 51 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (88)
Current report
We are a clinical-stage biopharmaceutical company pioneering the development of targeted radiotherapies to address significant unmet medical needs in oncology. We are focused on employing a biology-driven approach to develop differentiated, first-in-class radiopharmaceutical therapeutics for patients with solid tumors and hematologic malignancies. Our mission is to transform cancer treatment by delivering innovative, high-value radioconjugates that maximize therapeutic efficacy while minimizing toxicity to healthy tissue by combining our deep understanding of tumor biology and translational medicine with our expertise in radiochemistry.
Current report
Since our inception, we have focused on developing innovative and differentiated radiotherapies. Our pipeline of both early and later stage development programs is a testimony to our approach in three areas with: (1) two novel solid tumor product candidates, ATNM-400 and Actimab-A, with pan-tumor potential, (2) Actimab-A, which is also being developed as a therapeutic backbone for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in partnership with the National Cancer Institute (NCI), and (3) two targeted conditioning agents, Iomab-B for bone marrow transplant and Iomab-ACT for cell & gene therapies. Our solid tumor asset, ATNM-400, targets a novel antigen distinct from PSMA, with demonstrated preclinical activity across metastatic castration-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), and breast cancer. Actimab-A, targets myeloid derived suppressor cells (MDSCs) and is being studied in multiple solid tumors in combination with immune checkpoint inhibitors where MDSCs are known to act as an efficacy deterrent for these agents. Our hematology franchise includes: Actimab-A, a CD33-targeted therapy; as well as, Iomab-B and Iomab-ACT which are CD45-targeting conditioning agents. Both Actimab-A and Iomab-B are Phase 2/3 ready assets and are supported by extensive validation in over 15 clinical trials in which more than 500 patients were treated.
Current report
ATNM-400 is our lead solid tumor program, representing a first-in-class Ac-225 antibody radioconjugate targeting a novel, undisclosed, non-PSMA targeting antigen with expression across multiple solid tumor types. The ATNM-400 target is implicated in disease biology during tumor progression and is also overexpressed when tumors become resistant to many approved therapies in multiple solid tumors.
Current report
Our preclinical translational data demonstrated that ATNM-400 is superior to:
Current report
These preclinical translational data show that ATNM-400 works well as monotherapy but is even better in combination in resistant settings where the target is overexpressed as part of the resistance mechanism. Evidence of target expression has been observed ranging from 60%-80%+ in mCRPC, NSCLC, and breast cancer patient tumors, representing a significant addressable population of well over a hundred thousand patients in the United States based on our existing datasets. We believe this number may expand as we continue our work to demonstrate the potential of ATNM-400 in various additional disease and treatment settings.
Current report
Our preclinical development program has generated encouraging efficacy and mechanism-of-action data across multiple indication-specific animal models:
Current report
Prostate Cancer
Current report
ATNM-400 demonstrated specific tumor uptake and decreased tumor cell proliferation across preclinical models representative of clinically relevant mCRPC settings spanning ARPI-resistant disease as well as PSMA-high (C4-2), PSMA-low (22Rv1) and PSMA-negative (DU145) states. The results demonstrate ATNM-400’s PSMA-independent mechanism of action which provides an alternative which can address key limitations of current PSMA-targeted radioligand therapies. In these models, ATNM-400 showed significantly greater efficacy than both 177Lu-PSMA-617 (the active ingredient in Pluvicto®) and next-generation 225Ac-PSMA-617 in PSMA-low 22Rv1 prostate cancer xenograft models that are resistant to ARPI therapy. We believe greater efficacy against 225Ac-PSMA-617 suggests the importance of the ATNM-400 target as the energy delivered by the Ac-225 payload is the same. Efficacy was also observed in PSMA-negative DU145 models, supporting a profile differentiated from existing PSMA-targeted agents that predominantly act in PSMA-high disease. Importantly, ATNM-400 also demonstrated strong and durable combination activity with enzalutamide, with superior monotherapy efficacy compared to enzalutamide and 177Lu-PSMA-617 shown in ARPI-resistant prostate cancer models. We believe this superior combination activity is mechanistically supported by our observation that enzalutamide resistance increases ATNM-400 target expression in both prostate cancer models and mCRPC patient samples.
Current report
ATNM-400 Is Directed Against a Non-PSMA Target With the Potential to Treat More Patients Across Lines of Prostate Cancer Therapy
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ATNM-400 outperformed 177Lu-PSMA-617 (the active ingredient in Pluvicto®) and 225Ac-PSMA-617 in the PSMA-low, ARPI-resistant 22Rv1 prostate cancer model, demonstrating PSMA independent durable activity.
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ATNM-400 Tumor Growth Inhibition vs 177Lu-PSMA-617 and 225Ac-PSMA-617
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Survival benefit and greater tumor inhibition shown in models with ATNM-400 monotherapy and the combination of ATNM-400 + enzalutamide versus enzalutamide alone in ARPI-resistant 22Rv1 prostate cancer model.
Current report
ATNM-400 retained anti-tumor activity in prostate cancer models following progression on 177Lu-PSMA-617 and enzalutamide.
Current report
EGFR-Mutant NSCLC
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ATNM-400 demonstrated greater tumor growth inhibition than several marketed and late-stage development drugs in various settings. Specifically, ATNM-400 demonstrated 3-5 fold greater tumor growth inhibition compared to approved EGFR-targeted therapies including osimertinib (first-line), datopotamab deruxtecan (second-line), and amivantamab (third-line) in NCI-H1975 human lung cancer models harboring L858R and T790M EGFR mutations. In combination with osimertinib, ATNM-400 achieved 100% complete responses with durable efficacy extending throughout the preclinical study period. In head-to-head preclinical comparisons, ATNM-400 monotherapy, and ATNM-400 in combination with osimertinib, exceeded the tumor growth inhibition achieved by osimertinib plus chemotherapy, and ATNM-400 monotherapy exceeded Dato-DXd (a TROP-2 antibody-drug conjugate) and izalontamab brengitecan (a HER3-EGFR bispecific antibody-drug conjugate in development) in the same EGFR-mutant NSCLC model. We believe we have established mechanistic support for ATNM-400 combinations with EGFR inhibitors, demonstrating that osimertinib treatment increases ATNM-400 target expression both in vitro and in vivo. We believe this mechanistic synergy, combined with clinical data showing improved outcomes when osimertinib is combined with external beam radiotherapy, supports ATNM-400 development across multiple EGFR-mutant NSCLC treatment settings.
Current report
ATNM-400 achieved the highest tumor growth inhi bition(71%) versus approved targeted agents osimertinib (EGFR inhibitor), Dato-DXd (datopotamab deruxtecan, TROP-2 ADC )and amivantamab (EGFR-cMET ADC) in the NCI-H1975 EGFR-mutant NSCLC model. ATNM-400 + osimertinib combination achieved tumor shrinkage with 107% TGI and 100% of mice having complete cures in EGFR-mutant NSCLC model.
Current report
Osimertinib upregulated the ATNM-400 target in NCI-H1975 cells, enhancing ATNM-400 cytotoxicity when dosed in combination.
Current report
In preclinical EGFR-mutant NSCLC models, ATNM-400 demonstrated superior tumor growth inhibition compared to the leading approved therapy in each line of treatment — Tagrisso® (osimertinib), Rybrevant® (amivantamab), and Datroway® (datopotamab deruxtecan) — and showed combination activity with osimertinib exceeding the current first-line standard of care. With no targeted radiotherapy currently approved or in late-stage development for EGFR-mutant NSCLC, these data position ATNM-400 as a potentially first-in-class radiotherapeutic with applicability across multiple lines of therapy in one of the largest precision-oncology markets.
Current report
ATNM-400 vs Standard of Care Therapies in EGFR-mutant NSCLC
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Breast Cancer
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ATNM-400 demonstrated robust anti-tumor activity and tumor regression as monotherapy and in combination with trastuzumab in preclinical breast cancer models, including trastuzumab-resistant BT474-Clone5 model, HR+ breast cancer MCF-7 model and triple-negative breast cancer (TNBC) MDA-MB-468 model. In the trastuzumab-resistant setting, we observed increased expression of both the survival pathway marker p-AKT and the ATNM-400 target, with ATNM-400 treatment inducing DNA double-strand breaks as measured by p-H2AX staining. ATNM-400 achieved 66% tumor growth inhibition as monotherapy and 103% tumor growth inhibition (representing tumor regression) in trastuzumab-resistant preclinical models. In the trastuzumab-resistant BT474-Clone5 model, ATNM-400 anti-tumor activity was comparable to trastuzumab deruxtecan (T-DXd), and ATNM-400 sustained tumor growth inhibition following trastuzumab failure compared with control and T-DXd. The ATNM-400 target is overexpressed in breast cancer, including tumors resistant to endocrine therapies such as tamoxifen and HER2-targeted therapies, as well as in TNBC. Resistance to HER2-targeted and endocrine therapies along with the limited treatment options for triple-negative breast cancer (TNBC) represent areas of significant unmet medical need that are potentially addressable with ATNM-400.
Current report
ATNM-400 drove tumor regression both alone and in combination with trastuzumab in the trastuzumab-resistant BT474-Clone5 breast cancer model, yielding 95% and 101% TGI, respectively. ATNM-400 caused tumor regression (103% TGI) as monotherapy in the MDA-MB-468 TNBC model. ATNM-400 also caused dose-dependent tumor growth inhibition in the MCF-7 HR+ breast cancer model.
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MCF7 (HR+) Breast Cancer
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We have developed a theranostic strategy utilizing Zr-89 as a companion imaging agent to enable patient selection and tumor visualization. We believe this approach allows for non-invasive assessment of target expression and drug biodistribution prior to therapeutic administration, potentially enhancing the therapeutic index by selecting patients most likely to respond.
Current report
On April 21, 2026, preclinical data with ATNM-400 were presented at the American Association for Cancer Research (“AACR”) Annual Meeting in San Diego, California. The data further demonstrated pan-tumor efficacy across prostate, lung, and breast cancer models. The ATNM-400 presentation highlighted the following:
Current report
In Prostate Cancer
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ATNM-400 demonstrated PSMA independent activity across 22Rv1 (target-moderate/ PSMA-low), C4-2 (target-high/PSMA-high), and DU145 (target-low/PSMA-low) prostate cancer models.
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DU145: Low Target Expression and PSMA Negative
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In Lung Cancer
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ATNM-400 monotherapy (80% TGI) and ATNM-400 + osimertinib combination (89% TGI) exceeded standard-of-care osimertinib plus chemo combination (49% TGI) in the NCI-H1975 EGFR-mutant NSCLC model.
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**ATNM-400 Combination With Osimertinib vs Osimertinib Combination With Chemo In
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NCI-H1975 EGFR-m Lung Cancer
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ATNM-400 achieved higher tumor growth inhibition (80%) versus approved agent Dato-DXd (TROP-2 ADC) and izalontamab brengitecan (HER3-EGFR ADC) in the NCI-H1975 EGFR-mutant NSCLC model.
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ATNM-400 vs Dato-DXd or Izalontamab Brengitecan
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In Breast Cancer
Current report
ATNM-400 monotherapy (57% TGI) and combination with trastuzumab (100% TGI) showed anti-tumor effect in trastuzumab resistant BT474 Clone5 breast cancer model and was comparable to HER2-DXd (111% TGI). ATNM-400 was better at controlling post-trastuzumab failure (93% TGI) versus HER2-DXd (64% TGI).
Current report
Actimab-A for MDSCs: Novel Immunomodulatory Approach in Solid Tumors
Current report
Actimab-A (lintuzumab-Ac-225) is a CD33-targeted actinium-225 radioconjugate that we are developing to enhance checkpoint inhibitor efficacy by depleting immunosuppressive CD33+ myeloid-derived suppressor cells (MDSCs) in the tumor microenvironment. MDSCs are a heterogeneous population of immature myeloid cells that accumulate in solid tumors and suppress anti-tumor T-cell responses, representing a well-validated mechanism of resistance to PD-1/PD-L1 checkpoint inhibitors. By selectively eliminating these suppressive cells with targeted alpha-particle therapy, Actimab-A is designed to dismantle this barrier and restore an environment in which checkpoint blockade can drive meaningful T cell–mediated tumor killing. This positions Actimab-A as a differentiated immunomodulatory approach intended to expand the population of patients who benefit from checkpoint inhibitors, including those with tumors historically considered immunologically “cold.”
Current report
Actimab-A Depletion of MDSCs: Resensitizing PD-1 Inhibitors for T Cell Activation
Current report
Clinical studies have demonstrated that patients with high circulating MDSC levels have significantly reduced progression-free and overall survival on PD-1 therapy compared to patients with low MDSC levels.
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Removed paragraphs (119)
Previous report
Actinium Pharmaceuticals, Inc. is a pioneer in the development of differentiated, targeted radiotherapies intended to meaningfully improve outcomes for patients with advanced cancers. We are focused on developing highly innovative, first-in-class product candidates. To support our objective of achieving industry leading, cost-effective product development to maximize value creation from our innovative pipeline, we are working to expand the scope of our capabilities to include radioisotope production of Ac-225 via collaborations for our Ac-225 technology and in-house manufacturing of pipeline candidates to support clinical trials. We are deploying our technologies, capabilities and intellectual property with approximately 250 issued and pending patents worldwide, to develop next-generation radiotherapies focused on solid tumors, hematology and conditioning for cellular therapies.
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Our Targeted Radiotherapy Candidate Pipeline
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In addition to prioritized development efforts described above, we plan to continue to advance Actimab-A in a focused manner as a therapeutic for select hematology indications including supporting our Cooperative Research and Development Agreement (“CRADA”) with the National Cancer Institute (“NCI”). Actimab-A has the potential to address the significant unmet medical needs of patients across multiple solid tumor indications and with high-risk blood cancers including AML and MDS which are highly sensitive and susceptible to radiation. We also plan to support Iomab-ACT as a targeted conditioning agent for cell and gene therapies while simultaneously seeking strategic development partners or collaborators for these programs. We are actively seeking a strategic partner for Iomab-B, our CD45 targeted conditioning agent for bone marrow transplant (“BMT”) in the U.S. and we may seek to partner, divest, spin-out, or out-license Iomab-B, Actimab-A, and Iomab-ACT individually or collectively for all non-solid tumor indications. We believe, in the aggregate, the clinical data from these hematology and cellular therapy focused programs is supportive of a partnering approach, which if successful, may yield greater value as the Company focuses on its solid tumor development efforts utilizing existing resources.
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Recent Pipeline Candidate Highlights
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Solid Tumor Programs
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ATNM-400 is an antibody radioconjugate (“ARC”) armed with the potent alpha-emitter Ac-225. It is designed to deliver highly localized, potent alpha radiation to cancer cells while sparing normal tissue. ATNM-400 targets a clinically validated antigen that is overexpressed across multiple solid tumors and is associated with disease progression, therapeutic resistance, and poor clinical outcomes.
Previous report
Preclinical data across metastatic castrate-resistant prostate cancer (mCRPC), NSCLC, and breast cancer models demonstrate broad and durable anti-tumor efficacy with a favorable safety profile, supporting ATNM-400 as a pan-tumor Actinium-225 pipeline with potential to overcome resistance to multiple current standard therapies. These high-value indications total over 800,000 new cases each year in the U.S. alone. We believe ATNM-400 has the potential to address multiple segments in these indications that exceed $20 billion in market potential.
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ATNM-400 for Metastatic Castrate-Resistant Prostate Cancer
Previous report
Prostate cancer is the most commonly diagnosed cancer in men, with approximately 1.5 million new cases globally and over 313,000 expected in the U.S. in 2025. While early-stage disease is typically managed with surgery, radiation, and ARPI therapy, up to twenty percent of cases progress to mCRPC - a lethal stage with limited treatment options. Targeted radiotherapy is a growing field in prostate cancer, dominated by prostate specific membrane antigen (“PSMA”) targeting agents like Pluvicto®. However, approximately one-third of mCRPC patients are ineligible for or do not respond to Pluvicto and virtually all patients will develop resistance to or progress on Pluvicto® within twelve months. While ARPI therapies such as enzalutamide (active agent in Xtandi®, Pfizer/Astellas) and PSMA-targeted radiotherapies such as lutetium Lu 177 vipivotide tetraxetan (active agent in Pluvicto®, Novartis) have improved patient outcomes, treatment resistance is common.
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ATNM-400 targets a non-PSMA antigen that drives tumor survival and resistance mechanisms. High expression of this target correlates with rapid disease progression, shorter time to castration resistance, and poor survival.
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ATNM-400 Target Antigen Compared to PSMA
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In preclinical studies, including enzalutamide-resistant and PSMA-refractory mCRPC models, ATNM-400 demonstrated:
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The anti-tumor efficacy of ATNM-400 was durable up to 100 days compared to 177Lu-PSMA-617 or Ac-225-PSMA-617. ATNM-400 overcame 177Lu-PSMA-617 resistance with approximately 5-times long tumor control and 2-times longer overall survival (“OS”) in tumor bearing animals.
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Anti-tumor efficacy for up to 100 days was also demonstrated compared to ARPI enzalutamide. Increased target expression with enzalutamide and combination synergy with enzalutamide resulted in complete tumor regression in 40 percent of tumor bearing animals.
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In models that progressed on enzalutamide 177Lu-PSMA-617, subsequent treatment with ATNM-400 achieved robust tumor control and extended survival, highlighting the ability to overcome resistance given its novel antigen target and the potency of the Ac-225 alpha-emitter isotope.
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These results were presented at the Prostate Cancer Foundation (PCF) Scientific Retreat on October 24, 2025, and we believe provide for support for clinical development of ATNM-400 as:
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ATNM-400 for NSCLC
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Lung cancer is the most common cancer worldwide with more than 200,000 new cases estimated in 2025 in the U.S. and over 2 million new cases globally. NSCLC accounts for approximately 85 percent of all lung cancer cases with EGFR mutations detected in a significant portion of patients. Approved therapies for EGFR-mutant NSCLC include the tyrosine kinase inhibitor (“TKI”) osimertinib (TARGRISSO®, AstraZeneca) that virtually all patients receive as first-line treatment and the Trop-2 antibody drug conjugate Dato-DXd (DATROWAY®, AstraZeneca/Daiichi Sankyo) and EGFR-cMET bispecific antibody amivantamab (RYBREVANT®, J&J) that are used in second-and-third-line treatment settings. Despite initial treatment success with these therapies, nearly all patients eventually develop resistance within two to three years, underscoring the urgent need for novel, differentiated therapies to overcome resistance and improve survival outcomes.
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ATNM-400 targets an antigen associated with poor prognosis, metastasis, and EGFR-TKI resistance in NSCLC. In preclinical EGFR-mutant NSCLC models, including Osimertinib-resistant models, ATNM-400 demonstrated:
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Superior efficacy demonstrated by 3 to 5-times greater tumor growth inhibition compared with currently approved first, second-and-third line EGFR-mutant therapies osimertinib, Dato-Dxd and amivantamab in animals bearing human lung cancer NCI-H1975, which carry L858R and T790M EGFR mutations.
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The combination of ATNM-400 and osimertinib produced cures in all tumor-bearing animals with complete tumor regression, outperforming either agent alone and suggesting synergistic activity. The clinical rationale for the ATNM-400 osimertinib combination is further supported by the Phase 2 multicenter trial “osimertinib plus consolidative radiotherapy for advanced EGFR-mutant non-small cell lung cancer," (Sampath et al. The Lancet eClinical Medicine) that reported a median PFS of 32.3 months. This reflects a notable 12.3-month improvement in PFDS with the addition of external beam radiotherapy (“EBRT”) over the 20.0-month median PFS with osimertinib monotherapy, as reported by Watanabe et al. in a real-world clinical setting. ATNM-400 offers a potentially more effective and potentially safer way to deliver synergistic radiation than external beam radiotherapy given the significantly greater potency of Ac-225 compared to external beam, which on a per cell basis deliver approximately 4-8-times more biologically lethal radiation than diffuse low-energy EBRT. Clinically, this may translate to higher response rates, lower toxicity, and entry into previously untreatable market segments when osimertinib is combined with EBRT.
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Osimertinib treatment produced a statistically significant increase in the expression of the ATNM-400 target antigen in NCI-H1975 lung cancer cells. This increased target expression post-osimertinib notably increased ATNM-400’s in vitro cytotoxic effect when combined post-osimertinib.
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These data were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics on October 25, 2025, underscoring ATNM-400’s potential as a monotherapy or rational combination therapy for TKI-resistant NSCLC.
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ATNM-400 for HR+/HER2- Breast Cancer
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ATNM-400 is also being evaluated in breast cancer models resistant to both endocrine and HER2-targeted therapies. New data from this program, titled “Anti-tumor activity of ATNM-400, a first-in-class Actinium-225 antibody radioconjugate, in tamoxifen- and trastuzumab-resistant breast cancer models,” will be presented at the San Antonio Breast Cancer Symposium on December 11, 2025.
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This upcoming presentation will mark the first public disclosure of ATNM-400 activity in breast cancer, extending its potential application into hormone- and HER2-resistant tumors and reinforcing its pan-tumor therapeutic versatility.
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The expanding body of preclinical data across prostate, lung, and breast cancer models supports ATNM-400 as capable of addressing key resistance pathways across multiple solid tumors as depicted in the table below. ATNM-400 represents a differentiated, next-generation alpha radiotherapy product candidate positioned to extend Actinium-based precision radiotherapy that could address major unmet needs across multiple oncology indications.
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ATNM-400 Market Opportunity
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mCRPC
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Prostate cancer is by far the most diagnosed cancer in men in the United States and is the same in 118 of 185 countries. Of those diagnosed with prostate cancer, approximately 5-7% exhibited metastatic disease at initial diagnosis, and among those exhibiting localized prostate cancer, approximately 20-30% will progress to metastatic disease. A majority of metastatic prostate cancer patients receive hormone therapy such as ARPI therapy, as prostate cancer cells rely on androgen hormones for growth. Unlike localized disease, there are currently no known cures for metastatic prostate cancer – there are only treatments to slow the progression of disease.
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With the approval of Pluvicto® for patients with mCRPC post-taxane therapy and post ARPI therapy and prior to taxane therapy, targeted-radiotherapy has become a prominent component of the metastatic prostate cancer treatment paradigm. Pluvicto® generated sales of approximately $1.4 billion in the first nine months of 2025. In June 2025, Novartis announced expects to file an FDA submission in the second half of 2025 for Pluvicto® in metastatic hormone sensitive prostate cancer (“mHSPC”), that could add approximately 42,500 additional patients to the addressable market for Pluvicto®. With approximately one-third of patients not responding to PSMA-directed radiotherapy and that virtually all patients will progress on PSMA-directed radiotherapy within 12 months, we believe this demonstrates the high unmet need for a non-PSMA prostate cancer therapy such as ATNM-400.
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In August 2025, we received a letter from Novartis Pharmaceuticals Corporation (the “Novartis Letter”) that is incorporated in this Form 10-Q as an exhibit. In that letter, Novartis strongly objected to statements that Actinium made comparing ATNM-400 and Pluvicto®. Given that ATNM-400 is in preclinical development and that we clearly indicated as such, we believe that the Novartis Letter is highly unusual. We believe the particular statements cited by Novartis were not misleading and were accurate depictions of our research findings that evaluated ATNM-400 versus 177Lu-PSMA-617, the active agent in Pluvicto®as well as 225Ac-PSMA-617, a targeted radiotherapy that is not yet approved but is being evaluated by multiple companies including Novartis. As we have reported, ATNM-400 demonstrated superior tumor control and improved overall survival in preclinical studies in prostate cancer bearing animals compared to 177Lu-PSMA-617. In addition, ATNM-400 demonstrated efficacy in prostate cancer tumors that developed resistance to 177Lu-PSMA-617. Therefore, we do not agree with any of the claims made in the Novartis Letter and do not believe Novartis has requisite legal authority or basis to challenge Actinium. Therefore, we have not responded to Novartis but reserve all rights. We believe patients with mCRPC have high unmet needs that are not addressed by current therapies including Pluvicto® and intend to continue to develop ATNM-400 with the goal of addressing these patient needs.
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With the only approved targeted radiotherapy in prostate cancer moving up in the treatment paradigm with very few differentiated products in clinical development, we believe there is a significant potential market opportunity for ATNM-400. Currently, over 30 PSMA-targeted radiotherapies are in various stages of development, of which few offer a substantial efficacy advantage compared to Pluvicto®. Re-treatment with PSMA-targeting agents has not yet been supported substantially in controlled clinical trials and could be less effective than targeting a different antigen due to potential reduction of PSMA surface expression as well as increased tumor heterogeneity following initial PSMA-targeted therapy.
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We have demonstrated that ATNM-400’s differentiated target is expressed and druggable following ARPI therapy and PSMA radiotherapy. We believe ATNM-400 can therefore target a significant subset of the mCRPC patient population with aggressive disease who progressed on second generation ARPIs or have had no response to or progressed on Lu-177 labelled PSMA-targeted therapy. As ATNM-400 does not target PSMA, xerostomia or dry mouth, which can be a significant quality of life issue for patients with metastatic prostate cancer receiving PSMA-targeted radiotherapies as PSMA is expressed on salivary glands, would not be expected. Additionally, the antigen targeted by ATNM-400 is implicated in a pathway leading to ARPI-resistance in mCRPC patients and expression increases post-ARPI treatment; therefore, along with the tumor suppressing ability of Ac-225, ATNM-400 displays a compelling mechanism for synergy with ARPIs. This mechanistic synergy is supported by the complete tumor regression in 40 percent of tumor bearing animals treated with the combination of ATNM-400 and the ARPI enzalutamide. As a result, we believe ATNM-400 has the potential to address critical gaps in prostate cancer treatment as a monotherapy or in combination or sequenced with other therapeutic modalities.
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NSCLC
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Of the approximately 226,650 new lung cancer cases expected to be diagnosed in 2025, 85 percent are NSCLC of which a significant portion harbor an EGFR mutation. Approved therapies for EGFR-mutant NSCLC collectively generated approximately $7 billion in sales in 2024, including (TARGRISSO®, AstraZeneca) in the frontline setting that led the class with sales of $6.6 billion in 2024, the Trop-2 antibody drug conjugate Dato-DXd (DATROWAY®, AstraZeneca/Daiichi Sankyo) that was approved in January 2025 in the second line setting, and the EGFR-cMET bispecific antibody amivantamab (RYBREVANT®, J&J) in later lines that had sales of $0.3 billion in 2024. Despite osimertinib’s success as first-line therapy exhibited both in the FLAURA trial and through real-world evidence, disease progression is common, and the resistance mechanisms are highly heterogeneous, creating distinct patient segments for targeted therapies.
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Following progression on osimertinib, approximately half of the patients with EGFR mutant NSCLC are expected to undergo second line treatment where DATROWAY®is the approved standard-of-care. Despite the recent approvals of targeted therapies in the post-osimertinib treatment setting, a significant unmet need remains for targeted therapies that can provide durable treatment options beyond chemotherapy. ATNM-400 produced superior efficacy in the first-line setting as a monotherapy and in combination with the leading EGFR treatment osimertinib as well as superior efficacy compared to second-and-third-line EGFR therapies DATROWAY and RYBREVANT.
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EGFR-mutant NSCLC is a highly competitive field with AstraZeneca and Johnson & Johnson competing for market share for TAGRISSO® and RYBREVANT® with chemotherapy combinations aimed at improving OS and PFS. These chemotherapy combinations are currently being studied in clinical trials. AstraZeneca is conducting the FLAURA2 study to evaluate TAGRISSO® combined with chemotherapy and Johnson & Johnson is conducting the MARIPOSA trial studying RYBREVANT®. Improved survival outcomes have been reported in both studies compared to either agent alone, however, the addition of chemotherapy also resulted in increased toxicities. Notably, AstraZeneca and Johnson & Johnson have acquired or developed targeted radiotherapy assets and capabilities, however, their current assets are focused on prostate cancer. We believe the expansion into NSCLC represents significantly increases the potential addressable patient population for ATNM-400 and is also strategically aligned with the growing adoption of targeted radiotherapy by large biopharmaceutical companies and their therapeutics areas of interest.
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We believe ATNM-400 could enable the combination of targeted radiotherapy with EGFR therapies in a novel way, which could facilitate market share expansion and extend treatment windows. Specific to TAGRISSO, ATNM-400’s target antigen is statistically significantly increased following osimertinib treatment supporting a mechanistic synergy when used in combination. As noted above, preclinically the combination of ATNM-400 and osimertinib produced complete tumor regression in 100 percent of tumor bearing animals. The clinical rationale for the ATNM-400 combination is further supported by a Phase 2 multicenter trial that was supported by AstraZeneca that showed EBRT combined with osimertinib improved PFS (Sampath et al.Lancet eClinicalMedicine, 2025) by 61 percent compared to osimertinib alone. We believe ATNM-400 has the potential to deliver precision targeted, powerful alpha radiation via Ac-225 which on a per-cell basis is approximately up to 4 to 8-times more biologically lethal than diffuse, low-energy EBRT. This may translate to higher response rates, lower toxicity, and entry into previously untreatable market segments.
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HR+/HER2- Breast Cancer
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Previous wording
This Quarterly Report on Form 10-Q and other reports filed by the Company from time to time with the Securities and Exchange Commission contains or may contain certain forward-looking statements and information that are based upon beliefs of, and information currently available to, the Company’s management as well as estimates and assumptions made by Company’s management. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. For this purpose, any statements contained in this Quarterly Report on Form 10-Q that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “estimate” or “continue” or comparable terminology are intended to identify forward-looking statements. These statements by their nature involve substantial risks and uncertainties, and actual results may differ materially depending on a variety of factors, many of which are not within our control. These factors include but are not limited to economic conditions generally and in the industries in which we may participate; competition within our chosen industry, including competition from much larger competitors; technological advances and failure to successfully develop business relationships. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to actual results.
Current wording
This Quarterly Report on Form 10-Q and other reports filed by the Company from time to time with the Securities and Exchange Commission contains or may contain certain forward-looking statements and information that are based upon beliefs of, and information currently available to the Company’s management as well as estimates and assumptions made by the Company’s management. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. For this purpose, any statements contained in this Quarterly Report on Form 10-Q that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “estimate” or “continue” or comparable terminology are intended to identify forward-looking statements. These statements by their nature involve substantial risks and uncertainties, and actual results may differ materially depending on a variety of factors, many of which are not within our control. These factors include but are not limited to economic conditions generally and in the industries in which we may participate; competition within our chosen industry, including competition from much larger competitors; technological advances and failure to successfully develop business relationships. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to actual results.
Previous wording
ATNM-400: Differentiated, First-in-Class, Pan-Tumor Alpha-Targeted Precision Radiotherapy
Current wording
ATNM-400: First-in-Class Pan-Tumor Radiotherapy
Previous wording
Actimab-A + CLAG-M Phase 2/3 Trial
Current wording
Actimab-A + CLAG-M Phase 2/3 Trial Design
Previous wording
We are advancing clinical stage and preclinical stage targeted radiotherapy candidates directed against validated cancer targets for indications in solid tumors, hematology and conditioning for cell and gene therapies that we believe have high unmet needs not addressed by currently available treatment options. Recently prioritized as our lead program, ATNM-400, is a highly innovative, first-in-class, and pan-tumor Actinium-225 (“Ac-225”) alpha-emitter targeted radiotherapy candidate with preclinical data in prostate cancer, non-small cell lung cancer (“NSCLC”) and breast cancer. We believe ATNM-400 has the potential to address critical gaps across multiple treatment settings in each of these targeted indications and can therefore address large patient populations. Actimab-A is our most advanced clinical-stage product candidate, which utilizes an antibody linked to Ac-225 to target CD33, a cell surface protein that Actimab-A is designed to target, that is expressed ubiquitously in acute myeloid leukemia (“AML”) and myelodysplastic syndromes (“MDS”) and on myeloid derived suppressor cells (“MDSC”). We are evaluating Actimab-A’s potential to synergize with immune checkpoint inhibitors (“ICIs”) such as programmed cell death 1 (“PD-1) inhibitors in solid tumors by depleting MDSC immune cells. Iomab-ACT is our next-generation targeted conditioning agent we are developing with the intent to improve patient access to, and outcomes with, cellular therapies such as CAR-T for various blood cancer indications and gene therapies for non-malignant hematologic disorders such as sickle cell disease (“SCD”).
Current wording
Iomab-ACT: Universal Conditioning for Cell and Gene Therapies
Previous wording
Targeted Conditioning for Bone Marrow Transplant
Current wording
Iomab-B: Targeted Conditioning for Bone Marrow Transplant in R/R AML
Previous wording
As of November 13, 2025, we had 25 full-time employees, 12 of whom have Ph.D. or M.D. degrees and 20 of whom are engaged in research and development and clinical development activities. We believe that we have been successful to date in attracting skilled and experienced personnel despite the competitive hiring marketing in the industry. Our employees are not covered by a collective bargaining agreement, and we believe that our relationship with our employees is excellent. We continue to engage external consultants on an as-needed basis to temporarily supplement existing staff.
Current wording
As of May 7, 2026, we had 25 full-time employees, 12 of whom have Ph.D. or M.D. degrees and 21 of whom are engaged in research and development and clinical development activities. We believe that we have been successful to date in attracting skilled and experienced personnel despite the competitive hiring environment in the industry. Our employees are not covered by a collective bargaining agreement, and we believe that our relationship with our employees is excellent. We continue to engage external consultants on an as-needed basis to temporarily supplement existing staff.
Previous wording
The National Institutes of Health awarded us a Small Business Technology Transfer cost reimbursable grant to support a clinical collaboration with Memorial Sloan Kettering Cancer Center, or MSK, to study Iomab-ACT, our CD45-targeting Antibody Radio-Conjugate, for targeted conditioning to achieve lymphodepletion prior to administration of a CD19-targeted CAR T-cell therapy developed at MSK. We recognized other revenue during the three months ended September 30, 2025 of $0.1 million. There was no other revenue recognized for the three months ended September 30, 2024.
Current wording
The National Institutes of Health awarded us a Small Business Technology Transfer cost reimbursable grant to support a clinical collaboration with Memorial Sloan Kettering Cancer Center, or MSK, to study Iomab-ACT, our CD45-targeting Antibody Radio-Conjugate, for targeted conditioning to achieve lymphodepletion prior to administration of a CD19-targeted CAR T-cell therapy developed at MSK. There was no other revenue recognized for the three months ended March 31, 2026 and March 31, 2025, respectively.
Previous wording
On March 31, 2025, our Board of Directors approved the cancellation of certain stock options to purchase an aggregate of 4.9 million shares of common stock held by certain current employees and directors that were initially granted under our Amended and Restated 2013 Stock Plan and 2019 Amended and Restated Stock Plan. Such cancellations were subject to the consent of the applicable holders of the stock options.
Current wording
On March 31, 2025, our Board of Directors approved the cancellation of certain stock options to purchase an aggregate of 4.9 million shares of common stock held by certain current employees and directors that were initially granted under our Amended and Restated 2013 Stock Plan and our 2019 Stock Plan. Such cancellations were subject to the consent of the applicable holders of the stock options. The cancellation of these stock options resulted in the recording of $8.7 million in non-cash stock compensation expense for the three months ended March 31, 2025, $2.1 million in Research and development expense and $6.6 million in General and administrative expense.
Previous wording
Research and development expenses of $4.2 million for the three months ended September 30, 2025 decreased by $5.6 million from $9.8 million for the three months ended September 30, 2024. The decrease was primarily a result of a decline in outside CRO services and other preclinical R&D expenses of $4.3 million, lower compensation of $1.5 million due to lower headcount and lower non-cash stock-based compensation expense of $0.2 million due to the cancellation of stock options in March 2025. In the second quarter of 2025, we conducted a workforce optimization that reduced our headcount by approximately fourteen percent and announced a strategic pipeline prioritization.
Current wording
Research and development expenses, net of reimbursements, of $4.2 million for the three months ended March 31, 2026 decreased by $3.5 million from $7.7 million for the three months ended March 31, 2025. The cancellation of stock options in March 2025 described above resulted in lower non-cash stock-based compensation expense of $2.1 million for the three months ended March 31, 2026 compared with the three months ended March 31, 2025. In addition, there was a decline in outside CRO services and other preclinical R&D expenses of $1.0 million and lower compensation of $0.4 million due to lower headcount. In the second quarter of 2025, we conducted a workforce optimization that reduced our headcount by approximately fourteen percent and announced a strategic pipeline prioritization which resulted in additional departures in 2025.
Previous wording
General and administrative expense of $1.5 million for the three months ended September 30, 2025 decreased by $1.3 million from $2.8 million for the three months ended September 30, 2024. The cancellation of stock options in March 2025 described above resulted in lower non-cash stock-based compensation expense of $1.0 million for the three months ended September 30, 2025 compared with the three months ended September 30, 2024. In addition, compensation decreased $0.2 million due to lower headcount due to recent workforce optimization aligned with our strategic pipeline prioritization that reduced our headcount by approximately 14 percent.
Current wording
General and administrative expense of $1.7 million for the three months ended March 31, 2026 decreased by $7.2 million from $8.9 million for the three months ended March 31, 2025. The cancellation of stock options in March 2025 described above resulted in lower non-cash stock-based compensation expense of $6.6 million for the three months ended March 31, 2026 compared with the three months ended March 31, 2025. In addition, in comparison to the prior-year period, compensation decreased $0.3 million due to lower headcount and consulting and legal fees decreased $0.2 million as the company further rationalized efforts.
Previous wording
Other income is comprised of net interest income in both reporting periods. The amount for the three months ended September 30, 2025 of $0.6 million decreased from $1.0 million for the three months ended September 30, 2024 primarily due to a lower average cash balance during the respective time periods.
Current wording
Other income is comprised of net interest income in both reporting periods. The amount for the three months ended March 31, 2026 of $0.4 million decreased from $0.7 million for the three months ended March 31, 2025 primarily due to a lower average cash balance during the three months ended March 31, 2026 compared to the prior-year period.
Previous wording
Net loss of $5.1 million for the three months ended September 30, 2025 decreased by $6.5 million from $11.6 million for the three months ended September 30, 2024 primarily due to lower research and development expenses and lower general administrative expenses, partially offset by lower other income.
Current wording
Net loss of $5.5 million for the three months ended March 31, 2026 decreased by $10.4 million from $15.9 million for the three months ended March 31, 2025 due to lower research and development expenses and lower general and administrative expenses, partially offset by lower other income.
Previous wording
There was no cash used in investing activities for the nine months ended September 30, 2025. Cash used in investing activities was $11 thousand for the nine months ended September 30, 2024 due to the purchase of equipment.
Current wording
Cash used in investing activities for the three months ended March 31, 2026 was $2 thousand. There was no cash used in investing activities for the three months ended March 31, 2025.
Previous wording
In August 2020, we entered into the Capital on Demand™ Sales Agreement with JonesTrading Institutional Services LLC, or JonesTrading, pursuant to which we are able to sell, from time to time, through or to JonesTrading, up to an aggregate of $200 million of our common stock. On June 28, 2022, we entered into an Amendment and Restated Capital on Demand™ Sales Agreement, or the Amended Sales Agreement, with JonesTrading and B. Riley Securities, Inc. The Amended Sales Agreement modifies the original Capital on Demand™ Sales Agreement to include B. Riley as an additional sales agent thereunder. Shares of common stock are offered pursuant to a shelf registration statement on Form S-3 (File No. 333-273911), which was declared effective February 5, 2024, including a base prospectus covering the offering, issuance and sale of up to $500 million of common stock, preferred stock, warrants, units and/or subscription rights; and a sales agreement prospectus covering the offering, issuance and sale of up to a maximum aggregate offering price of $200 million of common stock that may be issued and sold under the Amended Sales Agreement. During the nine months ended September 30, 2025, there were no sales of shares of common stock. For the nine months ended September 30, 2024, we sold 3.5 million shares of common stock, resulting in gross proceeds of $29.9 million and net proceeds of $29.3 million.
Current wording
In August 2020, we entered into the Capital on Demand™ Sales Agreement with JonesTrading Institutional Services LLC, or JonesTrading, pursuant to which we are able to sell, from time to time, through or to JonesTrading, up to an aggregate of $200 million of our common stock. On June 28, 2022, we entered into an Amended and Restated Capital on Demand™ Sales Agreement, or the A&R Sales Agreement, with JonesTrading and B. Riley Securities, Inc. (“B. Riley”). The A&R Sales Agreement modifies the original Capital on Demand™ Sales Agreement to include B. Riley as an additional sales agent thereunder. Shares of common stock were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-242322) filed with the SEC on August 7, 2020 (the “Prior Shelf Registration Statement”). On August 11, 2023, we filed a registration statement on Form S-3 (File No. 333-273911), which was amended on February 2, 2024, and declared effective on February 5, 2024, to replace the Prior Shelf Registration Statement, including a base prospectus which covers the offering, issuance and sale of up to $500 million of common stock, preferred stock, warrants, units and/or subscription rights; and a sales agreement prospectus covering the offering, issuance and sale of up to a maximum aggregate offering price of $200 million of common stock that may be issued and sold under the A&R Sales Agreement. There was no sale of shares of common stock during the three months ended March 31, 2026 and 2025, respectively.
Previous wording
In September 2025, the FASB issued ASU 2025-07,Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic 606): Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract, which excludes from derivative accounting non-exchange-traded contracts with underlying terms that are based on operations or activities specific to one of the parties to the contract. However, this scope exception does not apply to (1) variables based on a market rate, market price, or market index, (2) variables based on the price or performance of a financial asset or financial liability of one of the parties to the contract, (3) contracts (or features) involving the issuer’s own equity that are evaluated under the guidance in Subtopic 815-40,Derivatives and Hedging—Contracts in Entity’s Own Equity, and (4) call options and put options on debt instruments. We can apply the amendments in AUS 2025-07 either (1) prospectively to new contracts entered into on or after the date of adoption or (2) on a modified retrospective basis through a cumulative-effect adjustment to the opening balance of retained earnings as of the beginning of the annual reporting period of adoption for contracts existing as of the beginning of the annual reporting period of adoption. The amendments in ASU 2025-07 are effective January 1, 2027, for annual for annual reporting periods, including interim periods within annual reporting periods. Early adoption is permitted. We are evaluating the impact of ASU 2025-07 on its financial statements.
Current wording
In September 2025, the FASB issued ASU 2025-07,Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic 606): Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract, which excludes from derivative accounting non-exchange-traded contracts with underlying terms that are based on operations or activities specific to one of the parties to the contract. However, this scope exception does not apply to (1) variables based on a market rate, market price, or market index, (2) variables based on the price or performance of a financial asset or financial liability of one of the parties to the contract, (3) contracts (or features) involving the issuer’s own equity that are evaluated under the guidance in Subtopic 815-40,Derivatives and Hedging—Contracts in Entity’s Own Equity, and (4) call options and put options on debt instruments. We can apply the amendments in AUS 2025-07 either (1) prospectively to new contracts entered into on or after the date of adoption or (2) on a modified retrospective basis through a cumulative-effect adjustment to the opening balance of retained earnings as of the beginning of the annual reporting period of adoption for contracts existing as of the beginning of the annual reporting period of adoption. The amendments in ASU 2025-07 are effective January 1, 2027, for annual reporting periods, including interim periods within annual reporting periods. Early adoption is permitted. We are evaluating the impact of ASU 2025-07 on our financial statements.
Previous wording
In May 2025, FASB issued ASU 2025-04,Compensation—Stock Compensation (Topic 718) and Revenue from Contracts with Customers (Topic 606): Clarifications to Share-Based Consideration Payable to a Customer, which revises the Master Glossary definition of the term “performance condition” for share-based consideration payable to a customer to include conditions, such as vesting conditions, that are based on the volume or monetary amount of a customer’s purchases or potential purchases of goods or services from the grantor, including over a specified period of time. The revised definition also incorporates performance targets based on purchases made by other parties that purchase the grantor’s goods or services from the grantor’s customers. The revised definition of the term performance condition cannot be applied by analogy to awards granted to employees and nonemployees in exchange for goods or services to be used or consumed in the grantor’s own operations. ASU 2025-04 eliminates the policy election permitting a grantor to account for forfeitures as they occur for share-based awards granted to a customer. Separate policy elections for forfeitures remain available for share-based payment awards with service conditions granted to employees and nonemployees in exchange for goods or services to be used or consumed in the grantor’s own operations. ASU 2025-04 further clarifies that a grantor should not apply the guidance in Topic 606 on constraining estimates of variable consideration to share-based consideration payable to a customer. ASU 2025-04 permits a grantor to apply the new guidance on either a modified retrospective or a retrospective basis. The amendments in ASU 2025-04 are effective January 1, 2027, for annual reporting periods, including interim periods within annual reporting periods. We are evaluating the impact of ASU 2025-04 on our financial statements.
Current wording
In May 2025, FASB issued ASU 2025-04,Compensation—Stock Compensation (Topic 718) and Revenue from Contracts with Customers (Topic 606): Clarifications to Share-Based Consideration Payable to a Customer, which revises the Master Glossary definition of the term “performance condition” for share-based consideration payable to a customer to include conditions, such as vesting conditions, that are based on the volume or monetary amount of a customer’s purchases or potential purchases of goods or services from the grantor, including over a specified period of time. The revised definition also incorporates performance targets based on purchases made by other parties that purchase the grantor’s goods or services from the grantor’s customers. The revised definition of the term performance condition cannot be applied by analogy to awards granted to employees and non-employees in exchange for goods or services to be used or consumed in the grantor’s own operations. ASU 2025-04 eliminates the policy election permitting a grantor to account for forfeitures as they occur for share-based awards granted to a customer. Separate policy elections for forfeitures remain available for share-based payment awards with service conditions granted to employees and non-employees in exchange for goods or services to be used or consumed in the grantor’s own operations. ASU 2025-04 further clarifies that a grantor should not apply the guidance in Topic 606 on constraining estimates of variable consideration to share-based consideration payable to a customer. ASU 2025-04 permits a grantor to apply the new guidance on either a modified retrospective or a retrospective basis. The amendments in ASU 2025-04 are effective January 1, 2027, for annual reporting periods, including interim periods within annual reporting periods. We are evaluating the impact of ASU 2025-04 on our financial statements.
Previous wording
The Company is subject to risks and uncertainties common to companies in the biopharmaceutical industry, including but not limited to, risks associated with completing preclinical studies and clinical trials, receiving regulatory approvals for product candidates, development by competitors of new biopharmaceutical products, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. In addition, the consequences of the ongoing geopolitical conflicts, such as the ongoing conflict between Russia and Ukraine and the ongoing conflict between Israel and Hamas, including related sanctions and countermeasures, and the effects of rising global inflation, are difficult to predict, and could adversely impact geopolitical and macroeconomic conditions, the global economy, and contribute to increased market volatility, which may in turn adversely affect our business and operations. The recent U.S. federal government shutdown, that began on October 1, 2025 and ended on November 12, 2025, curtailed operations of key agencies such as the FDA and the NIH, which includes the NCI, and may result in delays or disrupt our ability to advance clinical development of the current and planned clinical trials under our CRADA, obtain regulatory interactions/approvals, or secure government-funded grants. Additionally, recent changes to U.S. policy implemented by the U.S. Congress, the Trump administration or any new administration have impacted and may in the future impact, among other things, the U.S. and global economy, tariffs, international trade relations, unemployment, immigration, healthcare, taxation, the U.S. regulatory environment, inflation and other areas. Although we cannot predict the impact, if any, of these changes to our business, they could adversely affect our business. For a further discussion of factors that may affect future operating results see the sections entitled “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statement Notice.”
Current wording
The Company is subject to risks and uncertainties common to companies in the biopharmaceutical industry, including but not limited to, risks associated with completing preclinical studies and clinical trials, receiving regulatory approvals for product candidates, development by competitors of new biopharmaceutical products, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. In addition, the consequences of the ongoing geopolitical conflicts, such as the ongoing conflict between Russia and Ukraine and the ongoing conflicts in the Middle East, including related sanctions and countermeasures, and the effects of rising global inflation, are difficult to predict, and could adversely impact geopolitical and macroeconomic conditions, the global economy, and contribute to increased market volatility, which may in turn adversely affect our business and operations. In the past, U.S. federal government shutdowns, such as the shutdown that began on October 1, 2025 and ended on November 12, 2025, have curtailed operations of key agencies such as the FDA and the NIH, which includes the NCI. Future shutdowns may result in delays or disrupt our ability to advance clinical development of the current and planned clinical trials under our CRADA, obtain regulatory interactions/approvals, or secure government-funded grants. Additionally, changes to U.S. policy implemented by the U.S. Congress, the Trump administration or any new administration have impacted and may in the future impact, among other things, the U.S. and global economy, tariffs, international trade relations, unemployment, immigration, healthcare, taxation, the U.S. regulatory environment, inflation and other areas. Although we cannot predict the impact, if any, of these changes to our business, they could adversely affect our business. For a further discussion of factors that may affect future operating results see the sections entitled “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statement Notice.”
Rearranged previous paragraphs (6)
Previous report — wording carried elsewhere
On April 7, 2022, we entered into a License Agreement with Immedica Pharma AB (“Immedica”), pursuant to which Immedica licensed the exclusive product rights for commercialization of Iomab-B in certain countries in the EUMENA region. Upon signing, we were entitled to an upfront, non-refundable payment of $35.0 million from Immedica, which was received in May 2022. Under the terms of the License Agreement, we are eligible to receive certain regulatory and commercial milestone payments and royalties on net sales of the product in certain countries that may result from the License Agreement. Immedica is responsible for regulatory submissions in the EUMENA region, and we continue to retain commercialization rights in the U.S. and rest of the world.
Previous report — wording carried elsewhere
The following table sets forth, for the periods indicated, data derived from our statements of operations:
Previous report — wording carried elsewhere
We recorded no commercial revenue for the nine months ended September 30, 2025 and September 30, 2024, respectively.
Previous report — wording carried elsewhere
Research and Development Expense, net of reimbursements
Previous report — wording carried elsewhere
Research and development expenses of $16.8 million for the nine months ended September 30, 2025 decreased by $8.4 million from $25.2 million for the nine months ended September 30, 2024. The decrease was primarily a result of a decline in outside CRO services and other preclinical R&D expenses of $5.6 million and lower compensation of $3.8 million due to lower headcount. In the second quarter of 2025, we conducted a workforce optimization that reduced our headcount by approximately fourteen percent and announced a strategic pipeline prioritization. These decreases were partially offset by higher non-cash stock-based compensation of $1.2 million, due to the cancellation of stock options described above.
Previous report — wording carried elsewhere
Other income is comprised of net interest income in both reporting periods. The amount for the nine months ended September 30, 2025 of $1.9 million decreased from $3.0 million for the nine months ended September 30, 2024 primarily due to a lower average cash balance during the respective time periods.