VIVOS INC
For the period ended Mar 31, 2026. Filed May 14, 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 14, 2026
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What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001493152-25-021619
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-14.
0001493152-26-023146
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 91 previous paragraphs and 169 current paragraphs.
32 unchanged; 25 reworded; 111 added; 25 removed; 9 previous and 1 current paragraphs rearranged.
Tables are not compared: 11 previous and 21 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 (111)
Current report
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Current report
In the third quarter ended September 30, 2025, the Company strengthened its leadership team to support accelerating growth in both the U.S. and international markets by appointing Brad Allan Weeks as President (effective September 1, 2025) and David J. Swanberg as Chief Operating Officer (effective September 15, 2025). These appointments reflect the Company’s strategic response to rapid expansion, particularly in the IsoPet® Animal Therapy Division—which achieved a reported 1,200% year-over-year increase in administered therapies from 2024 to 2025—and ongoing advancements in RadioGel® human therapy development, including progress toward FDA Investigational Device Exemption (IDE) submission and the establishment of Vivos Scientific India LLP in September 2025. The new executive roles are designed to enhance operational efficiency, scale commercial activities, drive clinic certifications and therapy adoption, and position the Company for sustained growth and potential profitability in the Animal Therapy Division by 2026.
Current report
These enhancements maintain the intended use while maximizing the submission’s clarity, completeness, and alignment with Agency expectations. These recommendations required substantial effort to incorporate into our next submission.
Current report
Duncan Chiller – Akina encouraged Vivos to leverage our Peltier Chiller technology to develop a general laboratory equipment device for non-water localized chilling. An elementary device demonstrated proof of concept. A prototype will be produced at APEL for testing at and eventual distribution by Akina.
Current report
Trademark Protection continues to expand globally, now covering registrations and applications in 17 countries (with ongoing efforts to broaden this footprint):
Current report
The Company owns applications/registrations for the following key marks:
Current report
Patent Portfolio has been systematically strengthened through provisional and utility patent filings covering critical components of the platform, including the hydrogel formulation, yttrium-90 phosphate particles, injection/delivery systems, and related methods. These protections are pursued in the United States and in more than ten additional patent offices, encompassing approximately 63 countries.
Current report
Key recent milestones include:
Current report
These developments—highlighted in the Company’s January 28, 2026, press release—materially enhance Vivos’ intellectual property position, support ongoing clinical and regulatory progress (including FDA IDE efforts and international expansion via Vivos Scientific India LLP (VSIL)), enable broader global commercialization, and position the Company for potential strategic partnerships and licensing opportunities. The comprehensive IP portfolio, including four years of developmental data, validated Quality Management System documentation, and worldwide protections, provides a strong foundation for the Precision Radionuclide Therapy™ platform in both human and veterinary oncology.
Current report
In March and April 2026, the Company raised $2,203,800 through the sale of 27,200,000 shares of Common Stock through the Regulation A+ Offering and concurrent private placement of 27,800,000 warrants.
Current report
Cumulative proceeds from these offerings have supported critical advancements, including Breakthrough Device designation (December 2023), ongoing IDE resubmission preparations (with strengthened submission planned by end of Q1 or April 2026), international human therapy data generation in India, manufacturing diversification (new domestic facility at APEL in Richland, WA, and international site discussions aligned with Vivos Scientific India LLP (VSIL)), leadership enhancements, intellectual property expansion (e.g., U.S. Patent No. 12,521,452 B2 issued January 13, 2026, and additional provisional filings), and substantial growth in the IsoPet® Animal Therapy Division (1,200% year-over-year increase in administered therapies from 2024 to 2025).
Current report
Upon successful qualification, the 2026 Regulation A+ Offering would provide expanded capacity for equity fundraising to further advance RadioGel® human therapy development (including IDE submission and potential approval for clinical trials), scale IsoPet® commercialization (targeting breakeven in the Animal Therapy Division in 2026), support VSIL initiatives for local manufacturing and clinical trials in India, mitigate single-site production risks through multi-facility operations (targeted for 2026 readiness), and pursue broader global access to the Precision Radionuclide Therapy™ platform in both human and veterinary oncology. The Company continues to monitor cash needs closely and explore additional financing avenues as it progresses toward regulatory milestones and operational profitability.
Current report
Following receipt of required regulatory approvals (including potential FDA IDE clearance for human trials) and necessary financing to support working capital and expansion, the Company plans to transition to greater operational control over key aspects of its supply chain. In the U.S., Vivos is establishing Company-managed production facilities (with Vivos as the manufacturer of record) to produce Y-90 particles, hydrogel mixtures, and patient doses, while continuing to leverage select contract manufacturing during the transition period through Q2 2026. This approach aims to enhance supply chain resilience, reduce dependencies, and accommodate growing demand in both RadioGel® (human) and IsoPet® (veterinary) applications. For international markets, the Company is pursuing direct commercialization pathways through subsidiaries such as Vivos Scientific India LLP (VSIL), including local manufacturing and regulatory advancement in India, while remaining open to strategic licensing arrangements, partnerships, or collaborations to accelerate global access and market penetration for its Precision Radionuclide Therapy™ platform.
Current report
Long-term, the Company intends to consider resuming research on additional products and technologies to improve cancer diagnosis and treatment (e.g., expanded PRnT™ indications or PrecisionGel™ applications for other therapeutics). These goals depend on:
Current report
The Company’s corporate headquarters are located in Kennewick, Washington (Suite N288, 1030 N. Center Parkway, Kennewick, WA 99336), in the Tri-Cities region of Southeast Washington. The Company continues its marketing efforts in the IsoPet® animal therapy market, with a focus on expanding nationwide adoption across the U.S. Following substantial growth in 2025—including a reported 1,200% year-over-year increase in administered therapies, expansion to 17 certified clinics, and a sharp rise in inbound inquiries from veterinarians and pet owners—the Company is implementing profitability-focused initiatives starting in Q1 2026. These include ongoing clinic certifications (now billing clinics for the process), volume pricing to stimulate broader interest, and efforts to increase exposure, generate revenue, and scale the network of certified veterinary treatment centers nationwide. This national expansion builds on the therapy’s proven safety and efficacy (over 100 treatments with zero reportable serious adverse events) and supports the goal of achieving breakeven status in the Animal Therapy Division in 2026.
Current report
The Company anticipates allocating proceeds from the Regulation A+ Offerings (including the pending 2026 Regulation A+ Offering) primarily to advance its core Precision Radionuclide Therapy™ (PRnT™) platform across both veterinary and human applications, while supporting operational growth, regulatory progress, and manufacturing enhancements.
Current report
For the Human Market (RadioGel®):
Current report
These allocations align with the Company’s priorities of achieving breakeven in the Animal Therapy Division in 2026, securing FDA IDE clearance (with resubmission targeted for end of Q1/April 2026), diversifying manufacturing (targeting operational facilities in 2026), and generating additional clinical data to support global commercialization of RadioGel® and IsoPet®. Actual use may vary based on regulatory timelines, funding levels, and strategic opportunities.
Current report
The Company has vendor commitments for products and services, and current cash levels are insufficient to cover fixed and variable obligations or sustain ongoing product development. To minimize overhead, the Company has operated with a virtual office for several years and retained experienced industry consultants on an as-needed basis, allowing Regulation A+ Offering proceeds to focus on strategic objectives such as regulatory advancement, manufacturing diversification, and therapy commercialization.
Current report
IsoPet Animal Division
Current report
The Company selected Vista Veterinary Hospital in Kennewick, Washington (Tri-Cities area), as the pilot private clinic for initiating commercial IsoPet® sales. This location facilitated close collaboration with Company personnel to refine processes, serving as a model before national expansion. Vista has successfully passed multiple audits by the Washington State Department of Health, with the Company working closely alongside the Department to enhance the radioactive material license by incorporating detailed procedures that benefit future clinics. A second veterinarian at Vista has also been certified.
Current report
Clinical experience at universities and Vista demonstrates IsoPet®’s effectiveness in ablating cancer tissue near injection sites, performing best in early-stage tumors before metastasis. Later-stage cancers are more challenging due to poorly defined tendrils, increasing recurrence risk.
Current report
Johns Hopkins University Veterinary Clinical Trials Network (Baltimore, MD) is now a certified IsoPet® regional clinic, holding the required radioactive material license and completing training. This partnership supports high-quality data collection across cancer types for publication in leading journals, boosting awareness and acceptance in the veterinary oncology community. Johns Hopkins recently completed a VX2 tumor study in rabbits, confirming IsoPet® (and by extension RadioGel®) safety, with hydrogel retention at the injection site, activity decay curves, validation of Instructions for Use and Injection Guidance Table, and insights for refining human lymph node treatments.
Current report
Animal therapy safety and efficacy data from IsoPet® contributed positively to RadioGel®’s Breakthrough Device designation.
Current report
As of December 31, 2025, the Company has 17 certified regional clinics nationwide, treating feline, canine, equine, and exotic animals:
Current report
In 2024, three new dedicated websites were launched: the corporate site and separate ones for RadioGel® (human) and IsoPet® (veterinary), featuring user-friendly designs, educational content, and blogs to build authority. Marketing materials effectively highlight Precision Radionuclide Therapy™.
Current report
During 2025, the IsoPet® division achieved a reported 1,200% year-over-year increase in administered therapies, with over 100 safe treatments (zero serious adverse events). The team staffed booths at six conferences, and LeeAnna Binder conducted nationwide outreach via a modified IsoPet® van. Active social media management on Facebook, Instagram, X, and LinkedIn drove engagement and website traffic.
Current report
The division shifted from data collection to commercialization in 2024–2025, refining pricing for affordability, aligning production with patient bookings to reduce costs, and implementing volume pricing. Starting Q1 2026, profitability initiatives include billing clinics for certification and continued network expansion.
Current report
Objectives include adding several more regional clinics in 2026 (with interested parties in the pipeline) and participating in at least four conferences annually to promote IsoPet® for small animal and equine tumors. The Veterinary Medicine Steering Board advises patient acquisition strategies. This nationwide growth supports the goal of breakeven in the Animal Therapy Division in 2026.
Current report
FDA Regulatory Status- Recent Developments
Current report
Human Therapy
Current report
In November 2020 the Company submitted a request for a Breakthrough Device Designation. Ultimately, this was denied, but the FDA acknowledged, “The FDA does believe that RadioGel™ meets criterion #2a: Device represents breakthrough technology. Your devicedoes meet this criterion because it is a novel application of a precision radionuclide therapy device outside of the liver.” More importantly, the process resulted in a rapid review of our existing data and approach. It led to a redirection of our efforts on writing the Investigational Device Exemptions (“IDEs”) and saved the Company much time in the review of that future application.
Current report
Based on advice from the FDA the Company scheduled a Pre-Submission meeting on November 30, 2021 to discuss a draft of an IDE for Early Feasibility Medical Device Clinical Studies, including certain First in Human (“FIH”) Studies. Using this process results in more rapid feedback to prepare the final IDE.
Current report
The FDA was supportive and had suggested this Q-Submission path for rapid turnaround and dialog. The Mayo Clinic physicians did an excellent job presenting the need for Radiogel™ to treat recurrent thyroid cancer and to answer a range of questions from the new FDA review team. The FDA provided many helpful suggestions on a range of subjects from labeling to dosimetry to the Mayo Clinic protocol for clinical testing, and the need for some additional specific testing. They suggested having another Q-Sub Review and conference call dedicated to the details of the dosimetry calculations.
Current report
In May of 2022 the Company held another pre-submission meeting with the FDA. They concurred with our dosimetry techniques and requested one more animal test to confirm that the Y-90 stays at the injection site. We participated in another pre-submission meeting to discuss this new animal test of VX-2 tumors in rabbits at Johns Hopkins. We have a meeting scheduled with the FDA in October to obtain their feedback on our new animal test plan.
Current report
We held another pre-submission meeting with the FDA on October 17, 2022 to obtain detailed feedback on the proposed VX-2/Rabbit Animal Test Plan and to submit the Risk Management Report (“RMR”). The RMR analyzed all hypothetical scenarios and concluded that RadioGel is inherently safe.
Current report
We participated in pre-submission meetings with the FDA on April 10, 2023, and September 29, 2023, to discuss the preliminary results of the VX2 tumor animal study and to obtain feedback on the genotoxicity protocol.
Current report
After providing addition information to the FDA on December 18, 2023, the FDA classified us as a Breakthrough device to our proposed Indication for Use.
Current report
Since September 2024 the company has been engaged in the sprint process to discuss several FDA comments in detail. There will continue through February 2024, at which time we will re-submit the request for an IDE. In parallel, the Company is working with the Mayo Clinic’s principal investigators to improve the clinical trial protocol for their Institutional Review Board.
Current report
In July 2025 we applied for FDA IDE with an application approval containing new India human therapy data. In FDA August 2025 the FDA declined approval based on their detailed questions/concerns. In November 2025 we participated in a Pre-Submission meeting focused on sterilization to address their comments confirming completion of container closure integrity testing and to introduce the Agency to the Company’s enhanced Electron Beam (E-Beam) sterilization process for the RadioGel hydrogel to determine their reaction and recommendations.
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Removed paragraphs (25)
Previous report
In the third quarter ended September 30, 2025, we appointed a President and a Chief Operating Officer to account for our growth in the US and abroad.
Previous report
We confirmed that our current isotope, Y-90 was effective for all the targeted indications for use. However, we also decided to explore P-32, Lu-177, and Ac-225. P-32 is not as powerful as Y-90; however, we could modify the concentration, as it has a longer half-life, which could prove to be an advantage for international shipments. While Lu-177 is relatively low-energy, we could adjust the concentration, as it has a lower penetration distance, which might be an advantage in therapies near critical structures since that would result in a higher therapeutic ratio. Ac-225 has a very low penetration distance, but it would be distributed homogeneously in our hydrogel. This could be an advantage in treating brain tumors due to its extremely low alpha penetration.
Previous report
The Company is exploring the viability of leveraging its technology to develop other businesses unrelated to the Company’s principal business of cancer treatment. Each business opportunity could generate income to support our primary objectives or potentially be spun off as a separate business activity to an interested party. To date the focus has been on:
Previous report
Our trademark protection, which is extended to 17 countries, has been expanding continuously:
Previous report
We own applications/registrations for the following as noted below:
Previous report
We have systematically filed provisional and utility patents that cover our key components, hydrogel and the yttrium phosphate particles, and our injection system in the US patent office and in more than ten other offices covering approximately 63 counties.
Previous report
In January 2025 we filed an additional provisional patent on the control, transport, and delivery of PrecisionGel.
Previous report
Following receipt of required regulatory approvals and necessary financing to fund our working capital requirements, the Company intends to outsource material aspects of manufacturing, distribution, sales, and marketing for operations within the U.S. Outside of the U.S., the Company intends to pursue licensing arrangements and/or partnerships to facilitate its global commercialization strategy.
Previous report
Long-term, the Company intends to consider resuming research efforts with respect to other products and technologies intended to help improve the diagnosis and treatment of cancer and other illnesses. These long-term goals are subject to the Company: (i) receiving adequate funding; (ii) receiving regulatory approval for RadioGel™ and other brachytherapy products; and (iii) being able to successfully commercialize its brachytherapy products.
Previous report
The Company’s headquarters are in Northeast Washington, however, our focus on the animal therapy market has been the Northwestern sector of the U.S. The Company continues its marketing efforts on the animal therapy market and our attempts to increase the exposure to our product, and generate revenue accordingly.
Previous report
The Company anticipates using the proceeds from the July 2024 Regulation A+ Offering as follows:
Previous report
For the animal therapy market:
Previous report
For the human market:
Previous report
The Company intends to expand the indications for use in phases: first, for lymph nodes associated with thyroid cancer, secondly, cancerous lung nodules, and finally, all non-sectable solid tumors.
Previous report
Following receipt of required regulatory approvals and financing, in the U.S., the Company intends to outsource material aspects of manufacturing, distribution, sales and marketing. Outside of the U.S., the Company intends to pursue licensing arrangements and/or partnerships to facilitate its global commercialization strategy.
Previous report
Long-term, the Company intends to consider resuming research efforts with respect to other products and technologies, such as Gamma Gel and Alpha Gel intended to help improve the diagnosis and treatment of cancer and other illnesses. These long-term goals are subject to the Company: (1) receiving adequate funding; (2) receiving regulatory approval for RadioGel™ and other precision radionuclide therapy products; and (3) being able to successfully commercialize its precision radionuclide therapy products.
Previous report
The Company’s headquarters are in the State of Washington., The initial focus of the animal therapy market has been the Northwestern sector of the United States. The Company has initiated marketing efforts to the animal therapy market in other regions of the United States, attempting to increase the exposure to our product and increase revenue opportunities.
Previous report
There are currently commitments to vendors for products and services purchased. To continue the development of the Company’s products, the current level of cash will not be enough to cover the fixed and variable obligations of the Company. The Company has focused on operating on minimum overhead, including using a virtual office for the last several years and retaining experienced industry consultants available on an as needed basis. This has helped focus the capital received from the Company’s Regulation A+ Offerings on activities that enhance our objectives.
Previous report
Comparison of the Nine months Ended September 30, 2025 and 2024
Previous report
Non-Operating Income
Previous report
Non-operating income for the nine months ended September 30, 2025 and 2024 were as follows:
Previous report
Our net loss for the nine months ended September 30, 2025 and 2024 was $(1,987,503) and $(1,887,260), respectively.
Previous report
Operating Expenses
Previous report
Non-Operating Income
Reworded paragraphs (25)
Previous wording
Vivos Inc. (the “Company,” “we,” “us,” “our”) is a radiation oncology medical device company engaged in the development of its yttrium-90 (“Y-90”) based precision radionuclide therapy device, RadioGel™, for the treatment of non-resectable tumors, now trademarked as Precision Radionuclide Therapy™. A prominent team of radiochemists, scientists, and engineers, collaborating with strategic partners, including national laboratories, universities, and private corporations, lead the Company’s development efforts. The Company’s overall vision is to globally empower physicians, medical researchers, and patients by providing them with new isotope technologies that offer safe and effective treatments for cancer.
Current wording
Vivos Inc. (the “Company,” “we,” “us,” “our”) is a radiation oncology medical device company engaged in the development of its yttrium-90 (“Y-90”) based precision radionuclide therapy devices. This includes RadioGel® Precision Radionuclide Therapy™ (Human Division) for treating solid tumors and positive surgical margins in humans and IsoPet® (Animal Division) for treating solid tumors in animals. The Company also sells PLGA-g-PEG polymers and PrecisionGel™, a hydrogel polymer platform for delivering active pharmaceutical ingredients and therapeutic agents. A prominent team of radiochemists, scientists, and engineers, collaborating with strategic partners, including national laboratories, universities, and private corporations, lead the Company’s development efforts. The Company’s overall vision is to globally empower physicians, medical researchers, veterinarians, and patients by providing them with new isotope technologies and advanced polymer solutions that offer safe and effective treatments for cancer in both humans and animals.
Previous wording
In January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel™ should be classified as a device for animal therapy of feline sarcomas and canine soft tissue sarcomas. Additionally, after a legal review, the Company believes that the device classification obtained from the FDA Center for Veterinary Medicine is not limited to canine and feline sarcomas but rather may be extended to a much broader population of veterinary cancers, including all or most solid tumors in animals. We expect the result of such classification and label review will be that no additional regulatory approvals are necessary for the use of IsoPet®for the treatment of solid tumors in animals. The FDA does not have premarket authority over devices with a veterinary classification, and the manufacturers are responsible for assuring that the product is safe, effective, properly labeled, and otherwise in compliance with all applicable laws and regulations.
Current wording
In January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel® (now marketed as IsoPet® for veterinary use) should be classified as a medical device for animal therapy, initially specified for feline sarcomas and canine soft tissue sarcomas. Additionally, after legal review, the Company believes that this device classification from the FDA Center for Veterinary Medicine is not strictly limited to canine and feline sarcomas but may extend to a broader population of veterinary cancers, including all or most solid tumors in animals. As veterinary medical devices do not require premarket approval or notification (such as 510(k) or PMA) for commercial distribution in the United States, IsoPet® is authorized for marketing and commercial distribution following this classification, provided the product is safe, effective, properly labeled, and compliant with applicable laws and regulations. The FDA does not exercise premarket authority over veterinary devices, and manufacturers bear responsibility for ensuring ongoing compliance. This classification enables the commercial distribution of IsoPet® for treating solid tumors in animals.
Previous wording
The Company anticipates that any near-term profits, if any, will be derived from direct sales of RadioGel™ (under the name IsoPet®) and related services, and from certifying veterinary clinics to administer IsoPet Therapy. Until recently the Company certified clinics at its own expense, but the demand has increased to the point that starting in 2025 the Company billed its first clinic for the certification process. We have changed to “Volume Pricing” to stimulate interest. We are targeting to increase sales in 2025 to achieve a “Breakeven” status for the Animal Therapy Division in 2026.
Current wording
The Company anticipates that any near-term profits, if any, will be derived from direct sales of RadioGel® (under the name IsoPet®) and related services, and from certifying veterinary clinics to administer IsoPet Therapy. Until recently the Company certified clinics at its own expense, but the demand has increased to the point that starting in 2025 the Company billed its first clinic for the certification process. The Company has transitioned to “Volume Pricing” to stimulate broader interest and adoption. With significant growth achieved in 2025—including a reported 1,200% year-over-year increase in administered therapies and expansion of the certified clinic network—the Animal Therapy Division (IsoPet®) is positioned to reach breakeven status in 2026, supported by ongoing profitability-focused initiatives, continued clinic expansion, and improved operational efficiency.
Previous wording
On September 17, 2025, the Board of Directors of the Company approved the creation of Vivos Scientific India LLP (“Vivos India”), a wholly owned separate legal entity in India. Vivos India expands the Company’s strategic initiatives, with the objective of establishing a manufacturing center, expanding human therapies and pursuing commercialization of therapies in India. In addition, we will generate additional human trial data to support our process with the Food and Drug Administration (“FDA”). Vivos India was established on October 1, 2025.
Current wording
On September 17, 2025, the Board of Directors of the Company approved the creation of Vivos Scientific India LLP (“VSIL”), a wholly owned separate legal entity in India. Vivos India was formally established in September 2025 (with incorporation completed and government approvals finalized shortly thereafter), expanding the Company’s strategic initiatives in the region. The primary objectives include establishing the Company’s first international manufacturing center for RadioGel® and IsoPet®, advancing expanded human therapy demonstrations and clinical trials (including ongoing patient treatments initiated in December 2024 and progress toward DCGI regulatory clearance for larger-scale trials), pursuing commercialization of therapies for both humans and animals in India, and generating additional human trial data to support the Company’s regulatory processes with the U.S. Food and Drug Administration (FDA), such as the planned Investigational Device Exemption (IDE) submission in early 2026. As of February 2026, discussions continue with experienced radiopharmaceutical contract manufacturers in India to support the establishment of this international production facility, with a target for operational status by the end of 2026 to reduce shipping costs, enhance logistical efficiency, and facilitate broader global access to the Company’s precision radionuclide therapies.
Previous wording
Over time we intend to expand the indications for use to include all lymph nodes, lung cancer, childhood brain cancer, eyelid cancer, and finally all solid tumors. Interestingly, our health physics experts agreed on all isotopes, but determining the best isotope for each therapy rapidly downsized the prime candidates.
Current wording
Over time we intend to expand the indications for use to include all lymph nodes, lung cancer, childhood brain cancer, eyelid cancer, and finally all solid tumors. Our health physics experts reviewed the benefits of every available isotope, with respect to the target range of potential indication for use. This strategic group confirmed that our current isotope, Y-90 was effective for all the targeted indications for use. However, we also decided to explore P-32, Lu-177, and Ac-225.
Previous wording
Recent successful therapies of equine ocular tumors confirm the use of Y-90 and may impact the business case of development of alternate isotopes.
Current wording
Recent successful therapies of equine ocular tumors without damaging the eye and human therapy on cancerous nodes directly on the trachea without damaging that organ, confirm the use of Y-90 and may impact the business case of development of alternate isotopes.
Previous wording
Our trademarks include BetaGel and AlphaGel and our provisional patents cover the isotopes P-32, Lu-177, and Ac-225. Over the next two years we intend to conduct laboratory testing and then animal and finally human studies in India.
Current wording
Our trademarks include BetaGel and AlphaGel and our provisional patents cover the isotopes P-32, Lu-177, and Ac-225. Depending on the business case conclusions, over the next three years we intend to conduct laboratory testing and then animal and finally human studies in India.
Previous wording
In the second quarter of 2025, we signed a contract with Akina, Inc to sell this polymer. It is now in their catalog. The Company has had recent sales to a University and Pharmaceutical company, however the priority remains IDE approval.
Current wording
In the second quarter of 2025, we signed a contract with Akina, Inc to sell this polymer. It is now in their catalog. The Company has had recent sales to universities and pharmaceutical companies; we anticipate this will be a slow growing but solid market. The priority remains IDE approval.
Previous wording
Our original license agreement with Battelle National Laboratory (the “Battelle License”) reached its end of life in 2022. We have expanded our proprietary knowledge, as well as our trademark and patent protection, during the past several years in anticipation of the Battelle License reaching the end of its term
Current wording
The Company’s original license agreement with Battelle National Laboratory (the “Battelle License”) reached its end of life in 2022. In anticipation of this expiration, Vivos has significantly expanded its proprietary knowledge base, along with robust trademark and patent protections, over the past several years. The Company no longer relies on the Battelle license for any core intellectual or proprietary technology, having developed and secured independent advancements in its Precision Radionuclide Therapy™ (PRnT™) platform.
Previous wording
In November 2019, the SEC qualified the Company’s offering of its Common Stock, under Regulation A of Section 3(6) of the Securities Act of 1933, as amended (the “Securities Act”) (“Regulation A”), which offering was and amended from time to time thereafter (the “2019 Regulation A+ Offering”). In September 2021, the SEC qualified the Company’s offering of Common Stock under Regulation A, which offering was amended from time to time thereafter (the “2021 Regulation A Offering”). On July 17, 2024, the SEC qualified the Company’s offering under Regulation A to offer up to $60,000,000 shares of its Common Stock (the “July 2024 Regulation A+ Offering” and, together with the 2019 Regulation A+ Offering and the 2021 Regulation A Offering, the “Regulation A+ Offerings”.).
Current wording
In March 2026, the Company filed with the SEC an offering statement on Form 1-A (including a preliminary offering circular dated February 13, 2026, amended March 4, 2026) under Regulation A for the offering of up to $75.0 million of shares of its Common Stock, which offering was qualified by the SEC as of March 5, 2026 (the “2026 Regulation A+ Offering” and, together with the 2019 Regulation A+ Offering, 2021 Regulation A Offering, and July 2024 Regulation A+ Offering, the “Regulation A+ Offerings”).
Previous wording
During the year ended December 31, 2023, $1,179,245 was raised through the sale of 16,132,000 shares of Common Stock through the Regulation A+ Offerings and concurrent private placements of 18,797,000 warrants. During the year ended December 31, 2024, $2,266,000 was raised through the issuance of 24,950,000 shares of Common Stock through the Regulation A+ Offerings. During the nine months ended September 30, 2025, $1,500,000 was raised through the issuance of 12,500,000 shares of Common Stock through the Regulation A+ Offerings and $6,250 through a concurrent private placement of 6,250,000 warrants.
Current wording
During the year ended December 31, 2023, $1,179,245 was raised through the sale of 16,132,000 shares of Common Stock through the Regulation A+ Offerings and concurrent private placements of 18,797,000 warrants. During the year ended December 31, 2024, $2,266,000 was raised through the issuance of 24,950,000 shares of Common Stock through the Regulation A+ Offerings. During the year ended December 31, 2025, $1,500,000 was raised through the issuance of 12,500,000 shares of Common Stock through the Regulation A+ Offerings and $6,250 through a concurrent private placement of 6,250,000 warrants.
Previous wording
Based on the Company’s financial history since inception, the Company’s independent registered public accounting firm has expressed substantial doubt as to the Company’s ability to continue as a going concern. The Company has limited revenue, nominal cash, and has accumulated deficits since inception. If the Company cannot obtain sufficient additional capital, the Company will be required to delay the implementation of its business strategy and may not be able to continue operations.
Current wording
Based on the Company’s financial history since inception, the independent registered public accounting firm has expressed substantial doubt about the Company’s ability to continue as a going concern. The Company has limited revenue, nominal cash, and accumulated significant deficits. Without sufficient additional capital, the Company may need to delay its business strategy or may be unable to continue operations. Management continues to pursue fundraising (including the 2026 Regulation A+ Offering), cost controls, and key milestones—such as IsoPet® growth and potential breakeven in the Animal Therapy Division in 2026—to address liquidity challenges.
Previous wording
As of September 30, 2025, the Company had $2,202,109 in cash on hand. There are currently commitments to vendors for products and services purchased. To continue the development of the Company’s products, the current level of cash will be insufficient to cover the fixed and variable obligations of the Company.
Current wording
As of March 31, 2026, the Company had $2,525,782 in cash on hand. There are currently commitments to vendors for products and services purchased. To continue the development of the Company’s products, the current level of cash will be insufficient to cover the fixed and variable obligations of the Company.
Previous wording
Research and development of the Company’s precision radionuclide therapy product line has been funded with proceeds from the sale of equity and debt securities, including from the Prior Regulation A+ Offerings. The Company requires additional funding of approximately $3.0 million annually to maintain operating activities. Over the next 36 months, the Company believes it will require approximately $9.0 million in additional capital to: (i) fund the FDA approval process to conduct human clinical trials; (ii) conduct Phase I, pilot, clinical trials; (iii) activate several regional clinics to administer IsoPet®across the U.S.; (iv) create an independent production center within the current production site to create a template for future international manufacturing; and (v) initiate regulatory approval processes outside of the United States. The proceeds raised from the prior Regulation A+ Offerings were used to fund this development and proceeds from the July 2024 Regulation A+ Offering will be used to continue such development efforts.
Current wording
Research and development of the Company’s precision radionuclide therapy product line has been funded with proceeds from the sale of equity and debt securities, including from the Regulation A+ Offerings. The Company requires additional funding of approximately $3.0 million annually to maintain operating activities. Over the next 36 months, the Company believes it will require approximately $9.0 million in additional capital to: (i) fund the FDA approval process to conduct human clinical trials; (ii) conduct Phase I, pilot, clinical trials; (iii) activate several regional clinics to administer IsoPet®across the U.S.; (iv) create an independent production center within the current production site to create a template for future international manufacturing; and (v) initiate regulatory approval processes outside of the United States. The proceeds raised from the Regulation A+ Offerings were used to fund this development and will be used to continue such development efforts.
Previous wording
There is no guarantee that the Company will be able to raise additional funds or to do so on terms advantageous to the Company’s stockholders.
Current wording
There is no guarantee that the Company will secure additional funds or do so on favorable terms to stockholders.
Previous wording
The financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company’s continuation as a going concern is dependent upon its ability to generate sufficient cash flow to meet its obligations on a timely basis and ultimately to attain profitability. The Company plans to seek additional funding to maintain its operations through debt and equity financing and to improve operating performance through a focus on strategic products and increased efficiencies in business processes and improvements to the cost structure. There can be no assurance that the Company will be successful in its efforts to raise additional working capital or achieve profitable operations. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Current wording
The financial statements do not include adjustments for the recoverability and classification of liabilities that might be necessary if the Company cannot continue as a going concern. Continuation as a going concern depends on generating sufficient cash flow to meet obligations timely and ultimately achieving profitability. The independent registered public accounting firm has expressed substantial doubt about the Company’s ability to continue as a going concern due to limited revenue, nominal cash, and accumulated deficits since inception. Management plans to pursue additional funding through debt and equity financing (including the pending 2026 Regulation A+ Offering), enhance operating performance via strategic focus on core products, process efficiencies, and cost structure improvements. There can be no assurance of success in raising working capital or achieving profitable operations, and the financial statements include no adjustments for outcomes of this uncertainty.
Previous wording
The Company prepares and files annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and certain other information with the SEC. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at http://www.sec.gov. Moreover, the Company maintains a website at http://www.radiogel.com that contains important information about the Company, including biographies of key management personnel, as well as information about the Company’s business. This information is publicly available and is updated regularly.
Current wording
The Company prepares and files annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and certain other information with the SEC. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at http://www.sec.gov. Moreover, the Company maintains a website at http://www.RadioGel.com that contains important information about the Company, including biographies of key management personnel, as well as information about the Company’s business. This information is publicly available and is updated regularly. The content on any website referred to in this Annual Report is not incorporated by reference into this Annual Report, unless (and only to the extent) expressly so stated herein.
Previous wording
Revenue was $1,879 and $5,000 for the three months ended September 30, 2025 and 2024, respectively. All revenue recognized in the three months ended September 30, 2025 and 2024 relate to the procedures performed with respect to the IsoPet® therapies, sales of IsoPet®and freight.
Current wording
Revenue was $36,068 and $26,748 for the three months ended March 31, 2026 and 2025, respectively. All revenue recognized in the three months ended March 31, 2026 and 2025 relate to the procedures performed with respect to the IsoPet® therapies, sales of IsoPet®and freight.
Previous wording
Operating expense for the three months ended September 30, 2025 and 2024 was $518,208 and $844,226, respectively. The decrease in operating expense from 2024 to 2025 can be attributed to the decrease in professional fees ($627,152 for the three months ended September 30, 2024 versus $288,037 for the three months ended September 30, 2025) related to the fees incurred for the consultants engaged in 2025 versus 2024 and the decrease in the value of the vested RSUs; the increase in general and administrative expense ($65,123 for the three months ended September 30, 2024 versus $72,904 for the three months ended September 30, 2025); the increase in research and development ($66,551 for the three months ended September 30, 2024 versus $67,820 for the three months ended September 30, 2025) as the Company continued to ramp up the development of their products in 2025 in India as well as the US including research studies as well as continuing the steps necessary to be accepted by the FDA, and an increase in payroll expense ($85,400 for the three months ended September 30, 2024 versus $89,447 for the three months ended September 30, 2025) related to the CEOs employment contract and bonus.
Current wording
Operating expense for the three months ended March 31, 2026 and 2025 was $537,474 and $854,449, respectively. The decrease in operating expense from 2025 to 2026 can be attributed to the decrease in professional fees ($588,268 for the three months ended March 31, 2025 versus $285,432 for the three months ended March 31, 2026) related to the fees incurred for the consultants engaged in 2026 versus 2025 and the decrease in the value of the vested RSUs; the increase in general and administrative expense ($52,203 for the three months ended March 31, 2025 versus $58,685 for the three months ended March 31, 2026); the decrease in research and development ($119,281 for the three months ended March 31, 2025 versus $37,923 for the three months ended March 31, 2026) as the Company continued to ramp up the development of their products in 2025 in India as well as the US including research studies as well as continuing the steps necessary to be accepted by the FDA, and an increase in payroll expense ($94,697 for the three months ended March 31, 2025 versus $155,434 for the three months ended March 31, 2026) related to the CEOs employment contract and bonus, as well as the President’s payroll in 2026.
Previous wording
Non-operating income for the three months ended September 30, 2025 and 2024 were as follows:
Current wording
Non-operating income (expense) for the three months ended March 31, 2026 and 2025 were as follows:
Previous wording
Non-operating income for the three months ended September 30, 2025 and 2024 related to interest earned on the Company’s cash accounts.
Current wording
Non-operating income (expense) for the three months ended March 31, 2026 and 2025 related to interest earned on the Company’s cash accounts, and in 2026, the loss on exchange of warrants.
Previous wording
Our net loss for the three months ended September 30, 2025 and 2024 was $(507,294) and $(825,263), respectively.
Current wording
Our net loss for the three months ended March 31, 2026 and 2025 was $(1,184,845) and $(834,696), respectively.
Previous wording
At September 30, 2025, the Company had working capital of $2,182,492, as compared to working capital of $2,147,247 at December 31, 2024. As of September 30, 2025, the Company did not have any commitments for capital expenditures.
Current wording
At March 31, 2026, the Company had working capital of $2,427,649, as compared to working capital of $1,533,177 at December 31, 2025. As of March 31, 2026, the Company did not have any commitments for capital expenditures.
Previous wording
Net cash used in operating activities for the nine months ended September 30, 2025 and 2024, was $1,518,189 and $1,213,127, respectively. Cash used in operating activities was primarily related to the Company’s net loss from operations, stock-based compensation, as well as the changes in accounts receivable, inventory, prepaid expense, and accounts payable. During the nine months ended September 30, 2025 and 2024, there was no cash used in investing activities. Net cash provided by financing activities for the nine months ended September 30, 2025 and 2024 was $1,507,750 and $839,000, respectively, consisting of proceeds from the sales of Common Stock and warrants as part of our Regulation A+ Offerings.
Current wording
Net cash used in operating activities for the three months ended March 31, 2026 and 2025, was $429,861 and $455,198, respectively. Cash used in operating activities was primarily related to the Company’s net loss from operations, stock-based compensation, the loss on exchange of warrants as well as the changes in accounts receivable, inventory, prepaid expense, and accounts payable. During the three months ended March 31, 2026 and 2025, there was no cash used in investing activities except for the purchases of fixed assets in 2026 of $151,205. Net cash provided by financing activities for the three months ended March 31, 2026 and 2025 was $1,548,323 and $1,507,750, respectively, consisting of proceeds from the sales of Common Stock and warrants as part of our Regulation A+ Offerings and payments of lease obligations.
Previous wording
The Company has generated material operating losses since inception. The Company had a net loss of $1,987,503 for the nine months ended September 30, 2025 as compared to a net loss of $1,887,260 for the nine months ended September 30, 2024. The Company expects to continue to experience net operating losses for the foreseeable future. Historically, the Company has relied upon investor funds to maintain its operations and develop the Company’s business. The Company anticipates raising additional capital within the next twelve months for working capital as well as business expansion, although the Company can provide no assurance that additional capital will be available on terms acceptable to the Company, if at all. If the Company is unable to obtain additional financing to meet its working capital requirements, it may have to curtail its business or cease all operations.
Current wording
The Company has generated material operating losses since inception. The Company had a net loss of $1,184,845 for the three months ended March 31, 2026 as compared to a net loss of $834,696 for the three months ended March 31, 2025. The Company expects to continue to experience net operating losses for the foreseeable future. Historically, the Company has relied upon investor funds to maintain its operations and develop the Company’s business. The Company anticipates raising additional capital within the next twelve months for working capital as well as business expansion, although the Company can provide no assurance that additional capital will be available on terms acceptable to the Company, if at all. If the Company is unable to obtain additional financing to meet its working capital requirements, it may have to curtail its business or cease all operations.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
For the Animal Therapy Market (IsoPet®):
Rearranged previous paragraphs (9)
Previous report — wording carried elsewhere
Based on the Company’s financial history since inception, the Company’s independent registered public accounting firm has expressed substantial doubt as to the Company’s ability to continue as a going concern. The Company has limited revenue, nominal cash, and has accumulated deficits since inception. If the Company cannot obtain sufficient additional capital, the Company will be required to delay the implementation of its business strategy and may not be able to continue operations.
Previous report — wording carried elsewhere
The following table sets forth information from our statements of operations for the nine months ended September 30, 2025 and 2024:
Previous report — wording carried elsewhere
Revenue was $43,627 and $23,000 for the nine months ended September 30, 2025 and 2024, respectively. All revenue recognized in the nine months ended September 30, 2025 and 2024 relate to the procedures performed with respect to the IsoPet® therapies, sales of IsoPet®and freight. In 2025, we recognized revenue for the licensing and certification of clinics approximating $20,000.
Previous report — wording carried elsewhere
Operating expense for the nine months ended September 30, 2025 and 2024, respectively consists of the following:
Previous report — wording carried elsewhere
Operating expense for the nine months ended September 30, 2025 and 2024 was $2,012,678 and $1,944,885, respectively. The increase in operating expense from 2024 to 2025 can be attributed to the decrease in professional fees ($1,310,604 for the nine months ended September 30, 2024 versus $1,234,760 for the nine months ended September 30, 2025) related to the fees incurred for the consultants engaged in 2025 versus 2024 and decrease in value of RSUs vested; the increase in general and administrative expense ($143,468 for the nine months ended September 30, 2024 versus $206,021 for the nine months ended September 30, 2025); the increase in research and development ($223,660 for the nine months ended September 30, 2024 versus $295,066 for the nine months ended September 30, 2025) as the Company continued to ramp up the development of their products in 2025 in India as well as the US including research studies as well as continuing the steps necessary to be accepted by the FDA, and an increase in payroll expense ($267,153 for the nine months ended September 30, 2024 versus $276,831 for the nine months ended September 30, 2025) related to the CEOs employment contract and bonus.
Previous report — wording carried elsewhere
Non-operating income for the nine months ended September 30, 2025 and 2024 related to interest earned on the Company’s cash accounts.
Previous report — wording carried elsewhere
Revenues and Cost of Goods Sold
Previous report — wording carried elsewhere
Management does not anticipate that the Company will generate sufficient revenue to sustain operations until such time as the Company secures multiple revenue-generating arrangements with respect to RadioGel™ and/or any of our other brachytherapy technologies.
Previous report — wording carried elsewhere
Commencing in 2025, the Company had started ordering Hydrogel to use in more than one treatment. This is anticipated to increase the number of treatments that can be handled in a particular clinic monthly. As a result, we have inventory built up that when used will increase our cost of goods sold over time.