Actinium Pharmaceuticals, Inc.

Current report

Limitations under General Instructions I.B.6 of Form S-3 (the “baby shelf” limitation) may restrict our ability to raise additional capital.

Current report

Although we may continue to offer and sell shares of common stock under our existing at-the-market offering program up to the amount covered by the related prospectus supplement, our ability to conduct new or expanded primary offerings under Form S-3 may be limited while the aggregate market value of our voting and non-voting common equity held by non-affiliates remains below $75 million. Under General Instruction I.B.6 of Form S-3, we generally may not sell securities in primary offerings under Form S-3 having an aggregate market value exceeding one-third of our public float during any 12-calendar-month period. These limitations could reduce our flexibility to raise additional capital after the capacity under our existing at-the-market offering program is exhausted or otherwise unavailable and could require us to pursue alternative financing transactions that may be more costly, more dilutive or otherwise less favorable.

Current report

We are highly dependent on Sandesh Seth, our Chairman and Chief Executive Officer, and the loss of his services could be significantly more disruptive and costly to remediate than the loss of other members of management.

Current report

Mr. Seth has served as our Chairman since October 2013 and as our Chief Executive Officer since June 2017, and as a director since March 2012. He has over 25 years of experience spanning investment banking, equity research, and the pharmaceutical industry, including business development, strategic planning, and regulatory affairs, and holds a Regulatory Affairs Certification signifying proficiency with U.S. FDA regulations. In addition to leading our executive team, Mr. Seth is also a named inventor of over 30 issued and pending U.S. and international patents and patent applications which are foundationally applicable to ATNM-400, Actimab-A combined with MDSC’s and Iomab-ACT which are our important pipeline candidates.

Current report

Following the workforce reductions described below and the departure of other members of senior management, including our former Chief Financial Officer in February 2026 and our former Chief Strategy Officer, and Chief Medical Officer (position filled June 2026) as well as senior technical and clinical development personnel in 2025, Mr. Seth has assumed broad management responsibilities and has direct involvement with technical operations. Importantly, Mr. Seth possesses institutional knowledge of our scientific platform, regulatory strategy, intellectual property portfolio, key relationships, and capital markets history that cannot be duplicated by the rest of employees in their totality within our organization at this time.

Current report

We do not currently maintain key person life insurance on Mr. Seth. There can be no assurance that a suitable successor could be identified, recruited, or transitioned into his role without material disruption to our business, our ongoing regulatory and commercial strategy, or our relationships with investors, collaborators, and regulators.

Current report

Certain of our company-sponsored clinical development activities are conducted outside the United States through subsidiaries, clinical trial sites, contract research organizations, investigators and other third-party service providers. Conducting clinical development internationally may subject us to additional risks, including differences in regulatory requirements, ethics committee processes, patient recruitment and retention, clinical site performance, data collection standards, import and export controls, foreign currency fluctuations, local tax requirements, and operational or logistical disruptions. Any failure by our international service providers or clinical sites to comply with applicable requirements or meet expected timelines could delay patient enrollment, dosing, data readouts or regulatory submissions.

Current report

Our product candidates require specialized radiopharmaceutical manufacturing, isotope procurement, release testing and time-sensitive distribution to clinical sites, including sites located outside the United States. International clinical supply may require coordination among isotope suppliers, contract development and manufacturing organizations, couriers, customs brokers, clinical sites and regulatory authorities. Delays or disruptions in isotope availability, manufacturing slots, quality release, customs clearance, import/export approvals, transportation of radioactive materials or site scheduling could result in missed dosing windows, increased costs, product waste due to radioactive decay, protocol deviations or delays in clinical trial enrollment and data generation.

Current report

‘These requirements may be more complex when radioactive materials or radiopharmaceutical products are transported internationally, including requirements relating to import/export authorizations, customs clearance, local radiation safety rules, chain-of-custody procedures and specialized courier qualifications. Any failure to comply with such requirements, or any delay in obtaining required approvals or clearances, could delay clinical trial activities, increase costs or result in regulatory enforcement actions.

Current report

We conduct certain clinical development activities outside the United States, including through our wholly owned Australian subsidiary and third-party service providers, and we may conduct additional international development, regulatory, manufacturing, supply chain or commercialization activities in the future. Conducting operations outside the United States involves inherent risks, including, but not limited to, difficulties in staffing, funding and managing foreign operations; unexpected changes in regulatory requirements; differences in clinical trial, ethics committee, privacy, data protection, tax and healthcare requirements; export restrictions; tariffs and other trade barriers; import/export controls and customs requirements applicable to radioactive materials; difficulties in protecting, acquiring, enforcing and litigating intellectual property rights; difficulties in collecting accounts receivable; longer payment cycles; changes in tax laws; laws and business practices favoring local companies; compliance with tax, employment, immigration and labor laws for employees or contractors living or traveling abroad; the need to obtain required approvals from foreign governmental authorities; foreign currency fluctuations; and the potential imposition of restrictions on currency conversion or the transfer of funds.

Current report

We may not receive expected benefits from research and development tax incentives, including Australian research and development tax incentives, and any such benefits may be delayed, reduced, denied or subject to recapture.

Current report

We have applied for Australian research and development tax incentives associated with qualifying research activities conducted through our Australian subsidiary. Eligibility for such incentives depends on satisfaction of applicable requirements, including requirements relating to qualifying activities, eligible expenditures, documentation, registration, tax filings, and review by Australian governmental authorities. There can be no assurance that we will qualify for, receive, or retain any anticipated incentive amounts, or that such amounts will be received on the timing expected. Any denial, reduction, delay, audit adjustment or recapture of such incentives could adversely affect our cash flows, results of operations or financial condition. Changes in Australian tax laws, administrative practices or governmental funding policies could also reduce or eliminate the availability of such incentives in the future.

Previous report

Although we do not have any international operations at this time, we intend to seek market clearances in foreign markets that we believe will generate significant opportunities. However, even with the cooperation of a commercialization partner, conducting drug development in foreign countries involves inherent risks, including, but not limited to difficulties in staffing, funding and managing foreign operations; unexpected changes in regulatory requirements; export restrictions; tariffs and other trade barriers; difficulties in protecting, acquiring, enforcing and litigating intellectual property rights; fluctuations in currency exchange rates; and potentially adverse tax consequences.