VIVOS INC 10-K

ITEM 1. BUSINESS. 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. In 2013, the United States Food and Drug Administration (“ FDA ”) issued the determination that RadioGel ® is a device for human therapy for non-resectable cancers in humans. This should result in a faster path than a drug for final approval. 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. Based on the FDA’s recommendation, RadioGel ® is being marketed as “IsoPet ® ” for use by veterinarians to avoid any confusion between animal and human therapy. The Company already has trademark protection for the “IsoPet ® ” name. IsoPet ® and RadioGel ® are used synonymously throughout this document. The only distinction between IsoPet ® and RadioGel ® is the FDA’s recommendation that we use “IsoPet ® ” for veterinarian usage, and reserve “RadioGel ® ” for human therapy. Historically, the Company’s primary focus was on the development and marketing of Isopet ® for animal therapy, through the Company’s IsoPet ® Solutions division. Over the last four years much effort has been directed to completing the testing require to obtain FDA approval for an Investigational Device Exemption and to obtain approval for clinical trials in India. 3 The Company’s IsoPet Solutions division was established in May 2016 to focus on the veterinary oncology market, namely engagement of university veterinarian hospital to develop detailed therapy procedures to treat animal tumors and ultimately use of the technology in private clinics. In January 2025 the Company restructured and aligned its internal resources and focused efforts to align with animal therapy, human therapy, and recently other applications of its patented technologies. The Company has worked with five different national laboratories or university veterinarian hospitals on IsoPet ® /RadioGel™ testing and therapy. Washington State University treated five cats for feline sarcoma and served to develop the procedures which are incorporated in our label. They concluded that the product was safe and effective in killing cancer cells. Colorado State University demonstrated the CT and PET-CT imaging of IsoPet ® . The University of Missouri conducted an animal study to treat canine sarcoma. Johns Hopkins University completed a study on VX2 Tumors in Rabbits. Every study confirmed that the Y-90 stayed at the injection site with insignificant distribution outside that boundary. Commencing in July 2019, the Company recognized its first commercial sale of IsoPet®. A veterinarian from Alaska brought his cat with a re-occurrent spindle cell sarcoma tumor on his face. The cat had previously received external beam therapy, but now the tumor was growing rapidly. He was given a high dose of 400Gy with heavy therapy at the margins. 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. The plan is to incorporate the data assembled from our work with Isopet ® in animal therapy to support the Company’s efforts in the development of our RadioGel™ device candidate, including obtaining approval from the FDA to market and sell RadioGel ® as a Class II medical device. RadioGel ® is an injectable particle-gel for Precision Radionuclide Therapy radiation treatment of cancerous tumors in people and animals. RadioGel ® is comprised of a hydrogel, or a substance that is liquid at room temperature and then gels when reaching body temperature after injection into a tumor. In the gel are small, less than two microns, Y-90 phosphate particles. Once injected, these inert particles are locked in place inside the tumor by the gel, delivering a very high local radiation dose. The radiation is beta, consisting of high-speed electrons. These electrons only travel a short distance so the device can deliver high radiation to the tumor with minimal dose to the surrounding tissue. Optimally, patients can go home immediately following treatment without the risk of radiation exposure to family members. Since Y-90 has a half-life of 2.7 days, the radioactivity drops to 5% of its original value after ten days. In 2021 the Company modified its Indication for Use from skin cancer to cancerous tissue or solid tumors pathologically associated with locoregional papillary thyroid carcinoma and recurrent papillary thyroid carcinoma having discernable tumors associated with metastatic lymph nodes or extranodal disease in patients who are not surgical candidates or who have declined surgery, or patients who require post-surgical remnant ablation (for example, after prior incomplete radioiodine therapy). Papillary thyroid carcinoma belongs to the general class of head and neck tumors for which tumors are accessible by intraoperative direct needle injection. The Company’s Medical Advisory Board felt that demonstrating efficacy in clinical trials with this new indication provided a more efficient pathway to regulatory clearance. 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. 4 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. Strategic Initiatives ● IDE - In December 2023, the FDA granted RadioGel® Precision Radionuclide Therapy™ the designation as a Breakthrough Device pursuant to the FDA’s Breakthrough Devices Program, thereby giving the Company access to the “sprint” rapid review process for IDE comments. For the first two quarters of 2025, the Company took advantage of the process to resolve detailed FDA questions on a variety of topics. On August 13, 2025, the FDA rejected the Company’s IDE based on cited deficiencies. Based on the FDA recommendations, the Company used the pre-submission process to respond to the FDA’s comments. On October 14, 2025, the Company submitted the pre-submission document dedicated to sterility. This document incorporated the new E-Beam sterilization process. Over the past several years, the Company has engaged extensively with the FDA, successfully addressing feedback from more than 40 individual reviewers—many comments stemming from frequent review team changes within the Agency. Vivos has provided comprehensive data and finalized the key technical parameters related to demonstrating precision delivery of RadioGel ® to the treatment area and ensuring minimal exposure to non-target tissues. In a key strategic move, Vivos has engaged one of the top regulatory experts in the field of brachytherapy and combination radiotherapy devices, with deep experience guiding such products through the FDA’s Center for Devices and Radiological Health (CDRH). This expert’s prior role at the FDA and proven track record of successful IDE approvals for Class III implantable radiation device, several reviewed by the same branch overseeing RadioGel ® , have provided invaluable guidance. With this expert’s analysis of FDA feedback patterns, the Company is bolstering its IDE submission by: 1. Fully addressing all outstanding FDA concerns and adopting a submission format and structure proven effective by regulatory experts for similar devices. 2 . Incorporating additional information from clinical human data that has become available since the Company’s last IDE submission, further strengthening the evidence package. 3. Reformatting and summarizing pre-clinical data in a manner that more directly and effectively addresses the remaining FDA concerns. 4. Leveraging extensive veterinary clinical data from IsoPet ® commercial use: Integrating comprehensive treatment outcomes from over 100 safely administered therapies across diverse tumor types and species, with zero reportable serious adverse events attributable to the product, to provide additional real-world safety and efficacy evidence supporting the Precision Radionuclide Therapy™ platform. 5. Highlighting specialized equine ocular applications: Including detailed case data on successful treatments of ocular squamous cell carcinoma in horses (with injections near or into the cornea), showing no major side effects in adjacent critical structures, to further demonstrate the therapy’s precision, minimal invasiveness, and favorable risk profile in challenging anatomical locations. 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. 5 ● Commercialization of Human Therapy in India - The Company is actively pursuing an expanded permit from the Drugs Controller General of India (DCGI) to continue treating the initial cohort of up to 30 patients focused on head and neck cancers (including cancerous lymph nodes) and to initiate larger-scale clinical trials supporting potential commercial applications in India. This next phase would involve a second hospital site with a new principal investigator, incorporating an enhanced protocol that aligns with prior FDA feedback—such as post-treatment whole-body PET examinations for broader safety validation and efficacy assessment across additional tumor locations. In September 2025, the Company established Vivos Scientific India LLP (VSIL), a wholly owned subsidiary in India, to accelerate developmental testing, support regulatory processes (including DCGI clearances), expand human and animal therapy demonstrations, and lay the groundwork for the Company’s first international manufacturing center for RadioGel® and IsoPet®. The entity has secured its Certificate of Incorporation and completed key foundational steps (e.g., name reservation, digital signatures, and LLP Agreement filing), with headquarters in Mumbai, supported by an Indian Advisory Board. As of February 2026, VSIL is operational and advancing these initiatives, though full business activation and manufacturing setup remain in progress pending additional regulatory and logistical milestones. This subsidiary strengthens the Company’s long-term commitment to India as a key hub for clinical advancement, data generation to bolster the U.S. FDA pathway (e.g., IDE support), and eventual commercialization in both human oncology and veterinary applications. ● Animal Therapy in India – In the second quarter of 2025, the Company sponsored a highly successful “Pets in the Park” event in Mumbai, featuring a renowned speaker to raise awareness about pet cancer and introduce IsoPet® therapy. The event generated overwhelming positive response and demonstrated strong interest in initiating animal therapy in India. Building on this momentum, the Company has established solid contacts with interested veterinary clinics and key stakeholders in the region. The establishment of Vivos Scientific India LLP (VSIL) in September 2025 further supports these efforts by providing a dedicated local entity to advance developmental testing, pursue regulatory pathways for veterinary applications (complementing ongoing human therapy progress with the DCGI), and explore commercialization opportunities for IsoPet® in India. A local production site in India—targeted as part of the Company’s international manufacturing expansion, with one facility anticipated to become operational by the end of 2026—would significantly enhance cost-effectiveness by reducing shipping expenses, improving supply chain logistics, and enabling broader, more affordable access to IsoPet® Precision Radionuclide Therapy™ for veterinary use in the Indian market and beyond. This aligns with the Company’s global strategy to expand the IsoPet® division, which has already seen substantial growth in the U.S. (including a reported 1,200% year-over-year increase in administered therapies from 2024 to 2025), and positions India as a promising hub for both animal and human applications of the platform. ● Alternate Production Facilities – Previous corporate filings have highlighted risk factors associated with the Company’s reliance on a single production site. For the past two years, the Company has actively assessed alternate facilities to mitigate this risk and support scalable growth. In a significant step announced on February 17, 2026, Vivos Inc. is advancing plans to diversify its manufacturing base. The Company’s strategic target is to establish one domestic production facility—where Vivos will serve as the manufacturer of record—and one international production facility, both operational in 2026. These facilities will produce the yttrium-90 (Y-90) phosphate particles and mix them with sterile hydrogel to create individual patient doses for RadioGel® (human applications) and IsoPet® (veterinary applications). For the domestic site, Vivos has signed a contract for production space at the Applied Process Engineering Laboratory (APEL) in Richland, Washington. Equipment has been ordered, installation is underway, and licensing applications have been submitted to support operational readiness. The international facility is being pursued through ongoing discussions with experienced radiopharmaceutical contract manufacturers in India, aligned with the establishment and activities of Vivos Scientific India LLP (VSIL), to reduce shipping costs, enhance logistical efficiency, and expand access to global markets. The Company will continue production with its existing contract manufacturer through Q2 2026, ensuring continuity during the transition to these new facilities. This multi-site approach is expected to address previous single-source vulnerabilities, improve supply chain resilience, accommodate higher production volumes as demand grows (particularly in the IsoPet® division, which reported substantial therapy increases in 2025), and support the Company’s broader commercialization and regulatory goals for both human and animal therapies. ● Future Indications for Use and Alternate Isotopes – In December 2024, the Company conducted an offsite strategic meeting with our key technical staff, both our Medical and Veterinary Advisory Boards, our principal investigators from Mayo Clinic and India, and the Chairman of our Board. The objective was to determine our next target indications for use and to ensure that Y-90 was the best therapeutic isotope to treat these cancers. 6 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. ○ P-32 is not as energetic 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 and bone cancer due to its extremely low alpha penetration. 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. 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. ● 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: PrecisionGel – The Company spent years refining the development of its hydrogel, in which gelation initiates at room temperature and is completed as it warms to body temperature. The Company is currently investing in quantifying and controlling the hydrogel resorption and agent dispersal characteristics. There has been enough interest in this component to warrant a serious business case assessment. The Company has trademarked the name Precision Gel™ and, in addition to its current hydrogel patent, filed a new provisional patent in January 2025. In 2026 Akina and Vivos will release a publication to summarize years of development on our hydrogel, including rheology, resorption characteristics, concentration and composition control, and agent release data, including retention, transport, and release of a broad range of agents. It is anticipated that this publication will be beneficial to marketing Precision Gel. 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. 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. 7 Intellectual Property 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. Trademark Protection continues to expand globally, now covering registrations and applications in 17 countries (with ongoing efforts to broaden this footprint): The Company owns applications/registrations for the following key marks: ○ ISOPET® ○ RADIOGEL® ○ ALPHA-GEL™ ○ BETA-GEL™ ○ GAMMA-GEL™ ○ PRECISION RADIONUCLIDE THERAPY™ ○ PRECISIONGEL™ ○ Peltier Chlller © ○ Duncan Chiller™ 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. Key recent milestones include: ● In January 2025, the Company filed an additional provisional patent related to PrecisionGel™. ● On September 3, 2025, a provisional patent (No. 63/873,014) was filed for sterile thermogels using electron beam sterilization, enhancing manufacturing processes for the hydrogel component. ● On January 13, 2026, the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 12,521,452 B2, titled “Radiotherapy Gel and Method of Preparing the Same.” This patent protects critical advancements in the proprietary PRnT™ platform, including the integration of biodegradable, thermosensitive PLGA-g-PEG hydrogel with yttrium-90 particles for targeted beta radiation delivery into solid tumors while minimizing exposure to surrounding healthy tissue. It underpins the flagship products RadioGel® (human applications) and IsoPet® (veterinary use). ● Concurrently, PRECISIONGEL™ trademark approvals advanced, with publication in the U.S. and New Zealand. ● Additionally, the Company filed a new patent application in early 2026 to further protect and expand the PrecisionGel™ hydrogel technology, including its use for timed-release delivery of various therapeutic agents (e.g., anti-cancer drugs and gene therapies) beyond radionuclide applications. 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. Financing and Strategy 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”). 8 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. In March 2026, the Company raised $1,553,000 through the sale of 19,200,000 shares of Common Stock through the Regulation A+ Offering and concurrent private placement of 17,000,000 warrants. 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). 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. 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. 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: (i) securing adequate funding (e.g., via the pending 2026 Regulation A+ Offering or other sources); (ii) obtaining regulatory approvals for RadioGel® and related brachytherapy products (e.g., FDA IDE clearance, with submission planned by end of Q1/April 2026); and (iii) successfully commercializing current products (RadioGel® for humans and IsoPet® for veterinary use), including scaling adoption and operationalizing new manufacturing facilities in 2026. 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. 9 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. As of December 31, 2025, the Company had $1,558,525 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. 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. For the Animal Therapy Market (IsoPet®): ● Increase marketing and outreach via the Company website, social media, conferences, and publications to grow the number of certified veterinary clinics (for small animals and equine therapy) and expand patient treatments. ● Support controlled IsoPet® studies by providing complimentary products in exchange for data and publications on specific cancers, ensuring broader treatment access for viable candidates. ● Assist new regional clinics with licensing, certification training, and therapy demonstrations (including margin therapy applications). ● Transition to volume pricing to drive broader adoption and revenue growth. For the Human Market (RadioGel®): ● Expand and diversify production sites (including the new domestic facility in Richland, WA, and international site discussions aligned with Vivos Scientific India LLP (VSIL)) to mitigate single-source risks and scale capacity. ● Strengthen the Quality Management System pedigree for regulatory compliance. ● Initiate automation in product manufacturing processes. ● Secure liability insurance for human clinical studies. ● Fund human clinical studies and trials in the U.S. (post-IDE approval) and India (ongoing demonstrations and expanded DCGI-permitted trials). ● Establish and operationalize Vivos Scientific India LLP (VSIL) to support local manufacturing, regulatory advancement, and commercialization in India. 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. 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. 10 The continued deployment of precision radionuclide therapy products and a worldwide regulatory approval effort will require additional resources and personnel. The principal variables in the timing and amount of spending for the precision radionuclide therapy products in the next 12 to 24 months will be the FDA’s classification of the Company’s precision radionuclide therapy products as Class II or Class III devices (or otherwise) and any requirements for additional studies which may possibly include clinical studies. Thereafter, the principal variables in the amount of the Company’s spending and its financing requirements would be the timing of any approvals and the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing of those products and the products’ success in the U.S. and elsewhere. The Company intends to fund its activities through strategic transactions such as licensing and partnership agreements or from proceeds raised from the Regulation A+ Offerings. 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. There is no guarantee that the Company will secure additional funds or do so on favorable terms to stockholders. 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. IsoPet Animal Division 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. 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. 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. Animal therapy safety and efficacy data from IsoPet® contributed positively to RadioGel®’s Breakthrough Device designation. As of December 31, 2025, the Company has 17 certified regional clinics nationwide, treating feline, canine, equine, and exotic animals: 1. Vista Veterinary Hospital – Kennewick WA – (Drs. Michelle Meyer and Jeffrey Goebel) 2. University of Missouri – Columbia MO – (Dr. Charle Maitz) 3. Johns Hopkins University – Baltimore MD – (Dr. Rebecca Krimins) 4. Indian Creek Veterinary Hospital - Fort Wayne IN – (Dr. Kevin Cawood) 5. Hopkinton Animal Hospital - Weare NH – (Dr. Michael Dutton retiring, Dr. Jordan Gange) 11 6. NorthStar VETS - Robbinsville, NJ - (Dr. Diana Sanchez) 7. Animal Emergency & Specialty Center of Knoxville, Knoxville, NJ (Dr. Jeffrey Phillips) 8. Sumner Veterinary Hospital, Sumner, WA (Dr. Vanessa Rizzo) 9. New England Equine Practice – Patterson NY – (Dr. Bill Bradley) 10. Myhre Equine Clinic – Rochester NH – (Dr. Michael Myhre) 11. University of Wisconsin School of Veterinary Medicine - (Dr. Kayla Le) 12. University of Illinois College of Veterinary Medicine, Urbana, IL (Dr, Kimberly Selting) 13. Brazos Equine Hospital, Navasota, TX (Dr. Ben Buchanan) 14. University of Florida Large Animal Hospital (Dr. Diego De Gasperid) 15. Capital Veterinary Specialists (Drs. Kevin Drygas, Carl Jehn) 16. University of Florida Small Animal Hospital (Dr. Gutti, Dr. Takada) 17. Sun City Veterinary Surgical Center, El Paso, TX (Dr. Silverman) 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™. 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. 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. 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. FDA Regulatory Status- Recent Developments Human Therapy 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 device does 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. 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. 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. 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. 12 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. 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. 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. 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. 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. To maximize the probability of IDE approval on the next submission, in October 2025 the Company engaged one of the leading regulatory experts in the field of brachytherapy and combination radiotherapy devices. This expert has over 25 years of direct experience guiding such products through the FDA’s Center for Devices and Radiological Health (CDRH), including prior senior roles within the FDA’s Office of Device Evaluation. He has a proven track record of leading successful IDE approvals for multiple Class III implantable radiation devices, several of which were reviewed by the same Interventional Radiology and Oncology branch currently assigned to RadioGel®. His in-depth knowledge of this review team’s expectations, historical precedents, and common deficiency patterns has been instrumental in shaping the Company’s regulatory strategy. Currently, the IDE is in preparation under this expert’s guidance. The Company is positioned to incorporate final FDA input and submit the complete IDE application in the near term (targeted by the end of the first quarter or in April 2026). This expert’s proven ability to present complex IDE data in a format that this specific review panel can easily digest and understand has strengthened the submission, alongside integration of newly available human clinical data, reformatted pre-clinical information, and leveraging veterinary outcomes from IsoPet® (over 100 therapies with zero reportable serious adverse events). The Company remains encouraged by the constructive ongoing dialogue with the FDA and is strongly positioned for IDE approval to advance human clinical trials. The Medical Advisory Board (“ MAB ”) selected 18 applications for RadioGel™, each of which meet the criteria described above. This large number confirms the wide applicability of the device and defines the path for future business growth. The Company’s application establishes a single Indication for Use - treatment of cancerous tissue or solid tumors pathologically associated with locoregional papillary thyroid carcinoma and recurrent papillary thyroid carcinoma. We anticipate that this initial application will facilitate each subsequent application for additional Indications for Use. After the second Indication for Use, our objective is to apply for a broad Indication for Use which we would target to obtain approval to treat all solid tumors Radiogel™ Device Designation: In 2014, the Company submitted a presubmission (Q130140) to obtain FDA feedback about the proposed product. The FDA requested that the Company file a request for designation with the Office of Combination Products (RFD130051), which led to the determination that RadioGel™ is a device for human therapy for non-resectable cancers, which must be reviewed and ultimately regulated by the Center for Devices and Radiological Health (“ CDRH ”). The Company then submitted a 510(k) notice for RadioGel™ (K133368), which was found Not Substantially Equivalent due to the lack of a suitable predicate, and RadioGel™ was assigned to the Class III product code NAW (microspheres). Class III products or devices are generally the highest risk devices and are therefore subject to the highest level of regulatory review, control, and oversight. Class III products or devices must typically be approved by FDA before they are marketed. Class II devices represent lower risk products or devices than Class III and require fewer regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. In contrast, Class I products and devices are deemed to be lower risk than Class I or II, and are therefore subject to the least regulatory controls. 13 A pre-submission meeting (Q140496) was held with the FDA on June 17, 2014, during which the FDA maintained that RadioGel™ should be considered a Class III device and therefore subject to pre-market approval. On December 29, 2014, the Company submitted a de novo petition for RadioGel™ (DEN140043). The de novo petition was denied by the FDA on June 1, 2015, with the FDA providing numerous comments and questions. On September 29, 2015, the Company submitted a follow-up pre-submission informational meeting request with the FDA (Q151569). This meeting took place on November 9, 2015, at which time the FDA indicated acceptance of the Company’s applied dosimetry methods and clarified the FDA’s outstanding questions regarding RadioGel™. Following the November 2015 pre-submission meeting, the Company prepared a new pre-submission package to obtain FDA feedback on the proposed testing methods, intended to address the concerns raised by the FDA staff and to address the suitability of RadioGel™ for de novo reclassification. This pre-submission package was presented to the FDA in a meeting on August 29, 2017. During the August 2017 meeting, the FDA clarified their position on the remaining pre-clinical testing needed for RadioGel™. Specifically, the FDA addressed proposed dosimetry calculating techniques, dosimetry distribution between injections, hydrogel viscoelastic properties, and the details of the Company’s proposed animal testing. Product Features The Company’s RadioGel™ device has the following product features: ● Beta particles only travel a short distance so the device can deliver high radiation to the tumor with minimal dose to the nearby normal tissues. In medical terms Y-90 beta emitter has a high efficacy rate; ● Benefitting from the short penetration distance, the patient can go home immediately with no fear of exposure to family members, and there is a greatly reduced radiation risk to the doctor. A simple plastic tube around the syringe, gloves and safety glasses are all that is required. Other gamma emitting products require much more protection; ● A 2.7-day half-life means that only 5% of the radiation remains after ten days. This is in contrast to the industry-standard gamma irradiation product, which has a half-life of 17 days; ● The short half-life also means that any medical waste can be stored for thirty days then disposed as normal hospital waste; ● RadioGel™ can be administered with small diameter needles (27-gauge) so there is minimal damage to the normal tissue. This contrasts with the injection of metal seeds, which does considerable damage; and ● After about 120 days the gel resorbs by a normal biological cycle, called the Krebs Cycle. The only remaining evidence of the treatment are phosphate particles so small in diameter that it requires a high-resolution microscope to find them. This contrasts with permanent presence of metal seeds. Steps from Production to Therapy Device Production During 2025 the Company decided to expand its manufacturing capabilities and to target for on domestic and one international production center. Several candidates were assessed. Production of the Hydrogel RadioGel ™ is manufactured with a proprietary process under ventilated sterile hood by following strict Good Management Practices (“ GMP ”) procedures. It is made in large batches that are frozen for up to three months. When the product is ready to ship, a small quantity of the gel is dissolved in a sterile saline solution. It is then passed through an ultra-fine filter to ensure sterility. An alternate process of E-Beam sterilization was developed and verified. Limited GDA recommended testing will be conducted next year to obtain FDA approval for human therapy. 14 Production of the Yttrium-90 Phosphate Particles The Y-90 particles are produced with simple ingredients via a proprietary process, again following strict GMP procedures. They are then mixed into a phosphate-buffered saline solution. They can be produced in large batches for several shipments. The number of particles per shipment is determined by the dose prescribed by the doctor. Pre-Mixing – Ready to Use (“RTU”) The Company now pre-mixes the particle solution and the hydrogel and places the RTU IsoPet® in standard size vials. This innovation is cost effective and reduces the probability of any accidental spills or biological contamination at the therapy sites. It also simplified the certification training for new regional clinics. Shipment The vials are shipped inside the specially designed plastic shipping pigs via FedEx or UPS, all following the proper protocols. At the User The quantities and activities are in the information on the product label. The specific injection technique described on the Instructions for Use. For small tumors, one centimeter in diameter or less, the cancer is treated with a single injection. For larger tumors, the cancer is treated with a series of small injections from the same syringe or multiple syringes. Principal Markets The Company is currently pursuing two synergistic business sectors, medical and veterinary, each of which are summarized below. Medical Sector RadioGel ™ is currently fully developed, requiring only FDA approval before commercialization. Building on the FDA’s ruling of RadioGel ™ as a device, the Company incorporated the FDA suggestions and has invested in the pre-clinical testing required for IDE submittal. This included two years of effort on biocompatibility testing. The last remaining animal test has been completed, and the Company is engaged in the detailed sprint revie process, and the Company is engaged in the detailed sprint revie process. It has recently utilized the pre-submission process and the expertise of a well-respected advisor. Clinical trials have initiated in India. It is anticipated that these data, when it is restructured and expanded, will help accelerate FDA approval in the USA. We have applied for the regulatory approval to complete the remaining designated patients. Veterinary Sector The United States is home to approximately 163.6 million pet dogs and cats (with recent 2025 estimates from the American Veterinary Medical Association (the “ AVMA ”) indicating about 87.3 million dogs and 76.3 million cats). Cancer remains a leading health concern for these pets: roughly half of dogs over age 10 and a significant portion of older cats develop cancer, which is the number one natural cause of death in senior dogs and cats, accounting for nearly 50% of pet deaths in many cases. The National Cancer Institute and veterinary sources estimate that about 6 million dogs are diagnosed with cancer each year (more than 16,000 per day), with similar high incidence in cats. Product development, application techniques, and animal testing for IsoPet® (the veterinary branding of the yttrium-90 based therapy) are permitted under FDA regulations. For commercial sales in animals, the FDA’s Center for Veterinary Medicine (CVM) provides classification guidance. In January 2018, the CVM Product Classification Group ruled that RadioGel® (now marketed as IsoPet® for veterinary use) is classified as a medical device for animal therapy, initially for feline sarcomas and canine soft tissue sarcomas. 15 Following legal review, the Company believes this device classification is not strictly limited to those specific sarcomas but can extend to a broader range of veterinary cancers, including most or all solid tumors in animals. As veterinary medical devices do not require premarket approval, notification (e.g., 510(k)), or other premarket authorization from the FDA for commercial distribution in the United States, IsoPet® is authorized for marketing and use following this classification—provided the product is safe, effective, properly labeled, and compliant with all applicable laws and regulations. The FDA exercises no premarket authority over veterinary devices, placing responsibility on manufacturers to ensure ongoing compliance. This classification enables the commercial distribution of IsoPet® for treating solid tumors in animals without additional regulatory approvals. The IsoPet® division reported a 1,200% year-over-year increase in administered therapies from 2024 to 2025, as stated in the Company’s December 22, 2025, press release. This growth reflects accelerating nationwide adoption among veterinarians and pet owners seeking a precise, minimally invasive, and cost-effective alternative to conventional radiation or surgery for solid tumors. In recent months, the Company has observed a significant increase in inbound inquiries from veterinarians and pet owners regarding access to IsoPet® therapy, indicating growing awareness and demand for this targeted Precision Radionuclide Therapy™ platform. Starting in Q1 2026, the division is implementing profitability-focused initiatives, including billing clinics for certification training, applying volume pricing to encourage broader adoption, refining production scheduling for efficiency, and continuing to expand the network of certified clinics. To date, over 100 IsoPet® treatments have been safely administered across dogs, cats, horses, and exotic animals, with zero reportable serious adverse events attributable to the product. This veterinary clinical data supports ongoing commercialization efforts in the Animal Therapy Division and provides supporting safety and efficacy evidence for the shared yttrium-90 platform in the RadioGel® human program (including contributions to the Breakthrough Device designation and the pending IDE resubmission). With 17 certified clinics operational as of December 31, 2025, and additional interested sites in the pipeline, the Company is positioned to continue building on this momentum through scaled adoption, operational efficiencies, and strategic outreach (such as conferences, social media, and publications from case studies). These efforts support the target of achieving breakeven in the Animal Therapy Division in 2026. Competitors The Company competes in a market characterized by technological innovation, extensive research efforts, and significant competition. The pharmaceutical and biotechnology industries are intensely competitive and subject to rapid and significant technological changes. Several companies are pursuing the development of pharmaceuticals and products that target the same diseases and conditions that our products target. We cannot predict with accuracy the timing or impact of the introduction of potentially competitive products or their possible effect on our sales. Certain potentially competitive products to our products may be in various stages of development. Also, there may be many ongoing studies with currently marketed products and other developmental products, which may yield new data that could adversely impact the use of our products in their current and potential future Indications for Use. The introduction of competitive products could significantly reduce our sales, which, in turn would adversely impact our financial and operating results. There are a wide variety of cancer treatments approved and marketed in the U.S. and globally. General categories of treatment include surgery, chemotherapy, radiation therapy and immunotherapy. These products have a diverse set of success rates and side effects. The Company’s Radiogel™ precision radionuclide therapy product would generally compete with brachytherapy devices currently marketed in the U.S. and globally. The traditional iodine-125 (“ I-125 ”) and palladium-103 (“ Pd-103 ”) technologies are well entrenched with powerful market players. The industry-standard I-125-based therapy was developed by Oncura, which is a unit of General Electric Healthcare. Additionally, C.R. Bard, a major industry player competes in the I-125 marketplace. These market competitors are also involved in the distribution of Pd-103 based products. Cs-131 brachytherapy products are marketed by GT MedTech. Several Y-90 therapies have been FDA approved including SIR-Spheres by Sirtex, TheraSphere by Biocompatibles UK. 16 Raw Materials The Company currently subcontracts the manufacturing of RadioGel® (and IsoPet®) to its contract manufacturer in Texas (previously IsoTherapeutics, acquired by Telix Pharmaceuticals in April 2024). This acquisition prompted the Company to accelerate plans for manufacturing diversification to reduce dependency on a single provider and enhance supply chain resilience. Eckert & Ziegler serves as the sole supplier of yttrium-90 (Y-90), now sourced from their Massachusetts operations (previously from Germany). The Company procures additional supplies, hardware, handling equipment, and packaging from various U.S. suppliers. To address single-source risks, the Company is advancing toward multiple production alternatives targeted for 2026 operational status: ● One domestic facility where Vivos will act as the manufacturer of record (contract signed for space at the Applied Process Engineering Laboratory (APEL) in Richland, Washington; equipment ordered, installation underway, and licensing applications submitted). ● One international facility (ongoing discussions with experienced radiopharmaceutical contract manufacturers in India, aligned with Vivos Scientific India LLP (VSIL) activities to reduce shipping costs and support global access). The Company will continue production with the existing Texas contract manufacturer through Q2 2026 to ensure continuity during the transition. For the hydrogel polymer component (PrecisionGel™), the Company engaged Akina, Inc. as an alternate supplier in 2021. Efforts are underway to further expand Akina’s role to supply sterilized hydrogel (PrecisionGel™), supporting manufacturing scalability and compliance needs for both RadioGel® (human) and IsoPet® (veterinary) applications. These initiatives—detailed in the February 17, 2026, press release on manufacturing diversification—align with the Company’s strategy to mitigate supply chain vulnerabilities, accommodate growing demand (particularly in the IsoPet® division), and facilitate broader commercialization following regulatory progress (e.g., pending IDE resubmission). Customers The Company anticipates that potential customers for its Precision Radionuclide Therapy™ (PRnT™) products—RadioGel® for human applications and IsoPet® for veterinary use—will primarily include institutions and individuals already utilizing brachytherapy or other oncology treatments. For the veterinary market (IsoPet®), this encompasses certified veterinary clinics, university veterinary hospitals, specialty animal oncology centers, and private practices treating small animals (dogs and cats), equine patients (horses), and exotic species. Adoption has accelerated nationwide, with 17 certified regional clinics operational as of December 31, 2025, including academic institutions like the University of Florida (both small and large animal hospitals), Johns Hopkins University Veterinary Clinical Trials Network, University of Missouri, University of Wisconsin, University of Illinois, and private facilities such as Vista Veterinary Hospital, NorthStar VETS, and Sun City Veterinary Surgical Center. These clinics serve pet owners seeking minimally invasive, targeted alternatives to traditional surgery or external radiation for solid tumors. For human applications (RadioGel®), potential customers would include hospitals, oncology centers, interventional radiologists, and medical professionals treating non-resectable solid tumors, particularly in challenging anatomical locations. The therapy’s precision—delivering localized beta radiation via direct injection while minimizing exposure to healthy tissue—positions it as a compelling option for institutions focused on advanced radiotherapy. The veterinary and medical communities are expected to recognize Precision Radionuclide Therapy™ as an effective treatment for many solid tumors, supported by real-world veterinary data (over 100 safe treatments with zero reportable serious adverse events) and ongoing human demonstrations in India. Growing inbound inquiries from veterinarians, pet owners, and medical professionals, along with clinic expansions, publications from case studies, and marketing efforts (e.g., conferences, social media, and dedicated websites), are driving broader awareness and demand across both markets. The Company’s strategy emphasizes direct sales to certified clinics (veterinary) and eventual partnerships or institutional adoption (human), with scalability enhanced by manufacturing diversification targeted for 2026. 17 Government Regulation The Company’s present and future intended activities in the development, manufacturing, and sale of cancer therapy products, including RadioGel ™ , are subject to extensive laws, regulations, regulatory approvals, and guidelines. Within the United States, the Company’s therapeutic radiological devices must comply with the U.S. Federal Food, Drug and Cosmetic Act, which is enforced by FDA. The Company is also required to adhere to applicable FDA Quality System Regulations, also known as the Good Manufacturing Practices, which include extensive record keeping and periodic inspections of manufacturing facilities. In the United States, the FDA regulates, among other things, new product clearances and approvals to establish the safety and efficacy of these products. We are also subject to other federal and state laws and regulations, including the Occupational Safety and Health Act and the Environmental Protection Act. The Federal Food, Drug, and Cosmetic Act and other federal statutes and regulations govern or influence the research, testing, manufacture, safety, labeling, storage, record keeping, approval, distribution, use, reporting, advertising, and promotion of such products. Noncompliance with applicable requirements can result in civil penalties, recall, injunction or seizure of products, refusal of the government to approve or clear product approval applications, disqualification from sponsoring or conducting clinical investigations, preventing us from entering government supply contracts, withdrawal of previously approved applications, and criminal prosecution. In the United States, medical devices are classified into three different categories over which the FDA applies increasing levels of regulation: Class I, Class II, and Class III. Most Class I devices are exempt from premarket notification 510(k); most Class II devices require premarket notification 510(k); and most Class III devices require premarket approval. RadioGel ™ is currently classified as a Class III device. Approval of new Class III medical devices is a lengthy procedure and can take several years and require the expenditure of significant resources. There is a shorter FDA review and clearance process for Class II medical devices, the premarket notification or 510(k) process, whereby a company can market certain Class II medical devices that can be shown to be substantially equivalent to other legally marketed devices. As a registered medical device manufacturer with the FDA, we are subject to inspection to ensure compliance with FDA’s current Good Manufacturing Practices, or cGMP. These regulations require that we and any of our contract manufacturers design, manufacture, and service products, and maintain documents in a prescribed manner with respect to manufacturing, testing, distribution, storage, design control, and service activities. Modifications or enhancements that could significantly affect the safety or effectiveness of a device or that constitute a major change to the intended use of the device require a new 510(k) premarket notification for any significant product modification. The Medical Device Reporting regulation requires that we provide information to the FDA on deaths or serious injuries alleged to be associated with the use of our devices, as well as product malfunctions that are likely to cause or contribute to death or serious injury if the malfunction were to recur. Labeling and promotional activities are regulated by the FDA and, in some circumstances, by the Federal Trade Commission. As a medical device manufacturer, we are also subject to laws and regulations administered by governmental entities at the federal, state, and local levels. For example, our facility is licensed as a medical device manufacturing facility in the State of Washington and is subject to periodic state regulatory inspections. Our customers are also subject to a wide variety of laws and regulations that could affect the nature and scope of their relationships with us. In the United States, as a manufacturer of medical devices and devices utilizing radioactive byproduct material, we are subject to extensive regulation by not only federal governmental authorities, such as the FDA and FAA, but also by state and local governmental authorities, such as the Washington State Department of Health, to ensure such devices are safe and effective. In Washington State, the Department of Health, by agreement with the federal Nuclear Regulatory Commission (“ NRC ”), regulates the possession, use, and disposal of radioactive byproduct material as well as the manufacture of radioactive sealed sources to ensure compliance with state and federal laws and regulations. RadioGel ™ constitutes both medical devices and radioactive sealed sources and are subject to these regulations. Moreover, our use, management, and disposal of certain radioactive substances and wastes are subject to regulation by several federal and state agencies depending on the nature of the substance or waste material. We believe that we follow all federal and state regulations for this purpose. Vivos Inc has applied to Washington state for the manufacturing license to produce IsoPet and RadioGel. 18 Environmental Regulation Our business does not require us to comply with any extraordinary environmental regulations. Our RadioGel ™ product is manufactured in an independently owned and operated facility. Any environmental effects or contamination event that could result would be from the shipping company during shipment and misuse by the treatment facility upon arrival. Future operations in APEL have minimal environmental risk and are covered by liability insurance. Human Capital Since 2017, the Company has followed the cost-effective model of having had one full-time employee, the CEO. The Company utilizes several independent contractors to assist with its operations. This includes key positions, such as acting CFO and Quality Assurance Manager. The Company does not have a collective bargaining agreement with any of its personnel and believes its relations with its personnel are good. This enables the Company to operate on very low overhead, for cost-effective utilization of its investment and to manage our work scope like projects. In September 2025 the Company’s brought on a full-time President to assist the CEO in managing the Company which includes expansion both domestically and internationally. Available Information 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.