RDGL 10-K & 10-Q changes, risk factors and insider trading

The Company has generated material operating losses since inception. The Company has had recurring net losses since inception which has resulted in an accumulated deficit of $85,361,229$88,427,246 and $82,450,781$85,361,229 as of December 31, 20242025 and 2023,2024, respectively, including net losses of $2,910,448$3,066,017 and $2,894,753$2,910,448 for the years ended December 31, 20242025 and 2023.2024, respectively. Historically, the Company has relied upon investor funds to maintain its operations and develop its business. The Company needs to raise additional capital from investors for working capital as well as business expansion, and there is no assurance that additional investor funds will be available on terms acceptable to the Company, or at all. If the Company is unable to unable to obtain additional financing to meet its working capital requirements, the Company likely would cease operations.

The Company requires additional funding of approximately $3.5$3.0 million per year for Selling and General Administration costs andannually to fundmaintain itsoperating ongoing initiatives.activities. Over the next 36 months, the Company believes it will costrequire approximately $10$9.0 million in additional capital to: (1i) fund the FDA approval process to conduct human clinical trials; (2ii) conduct Phase I, pilot, clinical trials; (iii) activate several regional clinics to administer IsoPet® across the countyU.S.; (3iv) create an alternateindependent manufacturingproduction center based onwithin the current production site to create a template for future international manufacturing.manufacturing; and (v) initiate regulatory approval processes outside of the United States.

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 brachytherapyprecision radionuclide therapy products in the next 12 to 24 months will be the FDA’s classification of the Company’s brachytherapyprecision radionuclide therapy products as Class II or Class III devices (or otherwise) and any requirements for additional studies,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 United States of America (“U.S.”, or the “United States”) and elsewhere. The Company intends to fund its activities through strategic transactions such as licensing and partnership agreements or additionalfrom capitalproceeds raises.raised from the Regulation A+ Offerings.

TheOn Company has been working with the FDA to obtain clearance for its precision radionuclide therapy Y-90 RadioGelTM device, but no assurances have been received. On December 23, 2014, the Company announced that it submitted a de novo application to the FDA for marketing clearance for its patented Y-90 RadioGelTM device pursuant to Section 513(f)(2) of the U.S. Food, Drug and Cosmetic Act (the “Act”). In June 2015, the FDA notified the Company the de novo application was not granted. In February 2014, the FDA found the same device under Section 510(k) of the Act not substantially equivalent and concluded that the device is classified by statute as a Class III medical device, unless the device is reclassified. The Company is seeking reclassification of the product to Class II. If the Company is successful in seeking reconsideration of the Company’s de novo application, as a regulatory matter, the device could be on an easier and faster path to market in the United States. However, there would still be the requirements to complete the in vitro and in vivo testing, and then some human clinical trials. That testing date is submitted in a de novo pre-market application and if accepted we could then go to market. As a practical matter, the Company would still need to secure funding and commercial arrangements before marketing could commence. If the de novo application is declined and if the Company obtains funding to permit it to continue operations, the Company will explore steps toward seeking approval for the device as a Class III medical device. Generally, the time and cost of seeking approval as a Class III medical device is materially greater than the time and cost of seeking approval as a Class II medical device. If the Company seeks approval as a Class III device, human clinical trials will be necessary. Generally, human trials for Class III products are larger, of longer duration and costlier than those for Class II devices.

To mitigate this risk Dr. Korenko has been working with two internal candidates with the potential to seamlessly assume authority. Both David SwanbergSwanberg, Chief Operating Officer of the Company, and Brad Weeks, currentPresident active consultants toof the Company with broad responsivities,Company, have been identified as high potential candidates to succeed Dr. Korenko or to assume senior positions, although no formal arrangement has been reached. The Company Board would make the final appointment.Korenko. See “Directors, Executive Officers and Significant Consultants” on page 29.36.

The Company’s revenues relate to their commercializing of its products and procedures performed. The Company had $27,995$68,379 and $19,500$27,995 in operating revenues, net of discounts, forand the years ended December 31, 20242025 and 2023,2024, respectively, as we have commenced sales of IsoPet®.respectively

As a public company, the Company is subject to the reporting requirements of the Securities Exchange Act of 1934, as amended, and the Sarbanes-Oxley Act of 2002. The Company’s management is required to evaluate and disclose its assessment of the effectiveness of the Company’s internal control over financial reporting as of each year-end, including disclosing any “material weakness” in the Company’s internal control over financial reporting. A material weakness is a control deficiency, or combination of control deficiencies, that results in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected. As a result of its assessment, management has determined that there is a material weakness due to the lack of segregation of duties and, due to this material weakness, management concluded that, as of December 31, 20242025 and 2023,2024, the Company’s internal control over financial reporting was ineffective. This material weakness has the potential of adversely impacting the Company’s financial reporting process and the Company’s financial reports. Because of this material weakness, management also concluded that the Company’s disclosure controls and procedures were ineffective as of December 31, 20242025 and 2023.2024. The Company needshas toengaged hirethe services additional qualifiedof both internal accounting personneland tax providers to resolve this material weakness. The Company also will need to expend any additional resources and efforts that may be necessary to establish and to maintain the effectiveness of the Company’s internal control over financial reporting and disclosure controls and procedures.

Revenue was $27,995$68,379 and $19,500$27,995 for the years ended December 31, 20242025 and 2023,2024, respectively. All revenue recognized in the yearyears ended December 31, 20232025 and 2024 relate to the procedures performed with respect to the IsoPet® therapies.therapies, Allsales of IsoPet®and freight. In 2025, we recognized revenue except $4,995 in 2024 relate tofor the procedureslicensing performedand withcertification respect to the IsoPet® therapies. The $4,995 relates to a new license fee charged by the Company toof clinics forapproximating certification to perform these therapies. These revenues are recognized upon the certification being completed.$27,000.

Operating expense for the years ended December 31, 20242025 and 20232024 was $2,601,400$3,105,292 and $2,787,110,$2,601,400, respectively. The decreaseincrease in operating expense from 20232024 to 20242025 can be attributed to the increase in professional fees ($1,606,923 for the year ended December 31, 2023 compared to $1,682,350 for the year ended December 31, 2024) as the Company utilized more services duecompared to amending the offering statement on Form 1-A (the “Offering Statement”)$2,039,407 for the Company’syear offeringended beingDecember made31, pursuant2025) related to Regulation A+ (the “Regulation A+ Offering”), and the fees incurred for the consultants engaged in 2025 versus 2024, including: stock-based compensation; the increase in general and administrative expense ($165,773$241,824 for the year ended December 31, 20232024 compared to $241,824$296,556 for the year ended December 31, 2025); the increase in research and development expense ($324,629 for the year ended December 31, 2024); thecompared decreaseto in research and development expense ($732,698$352,232 for the year ended December 31, 2023 compared to $324,629 for the year ended December 31, 20242025) as the Company rampedcontinued to ramp up the development of their products in with2025 in India as well as the recentUS raisingincluding ofresearch capitalstudies inas 2023well as continuing the steps necessary to be accepted by the FDA; and, and, an increase in payroll expense ($281,716$352,597 for the year ended December 31, 20232024 compared to $352,597$417,097 for the year ended December 31, 2025) 2024) related to our Chief Executive Officer’s employment contract takingand effect.the addition of our Chief Operating Officer in the fourth quarter of 2025.

Non-operating income (expense) for the year ended December 31, 20232024 varied from the year ended December 31, 2024.2025. In 2023,2025, we recognized a loss on issuance of shares of $151,184 and interest earned on our bank accounts of $49,577.$99,030. In 2024, we recognized a loss on the exchange of warrants of $381,000, and incurred interest income of $74,936 related to our cash position in our bank accounts.

At December 31, 2024,2025, the Company had working capital of $2,147,247,$1,533,177, compared to working capital of $1,365,120$2,147,247 at December 31, 2023.2024. During the year ended December 31, 2025, the Company experienced negative cash flows from operations of $2,057,743, used $103,185 in cash flows from investing activities and realized $1,506,905 of cash flows from financing activities. As of December 31, 2025, the Company did not have any commitments for capital expenditures. During the year ended December 31, 2024, the Company experienced negative cash flows from operations of $1,684,039 and realized $2,304,300 of cash flows from financing activities. As of December 31, 2024, the Company did not have any commitments for capital expenditures. During the year ended December 31, 2023, the Company experienced negative cash flows from operations of $1,293,023 and realized $1,179,245 of cash flows from financing activities. As of December 31, 2023, the Company did not have any commitments for capital expenditures.

Cash used in operating activities was primarily a result of the Company’s non-cash items, such as loss from operations, loss on exchange of warrants, loss on conversion of debt and share based compensation. Cash used in investing activities in 2025 relate to purchases of fixed assets. Cash provided from financing activities increased fromdecreased $1,179,245to $1,506,905 for the year ended December 31, 20232025 tofrom $2,304,300 for the year ended December 31, 2024. In 2023,2025, the Company raised $1,179,245 $1,506,250 from sales of common stock. In 2024, the Company raised $2,284,950 from sales of common stock and warrants.

The Company requires funding of at least $3.5$3.0 million per year to maintain current operating activities. Over the next 36 months, the Company believes it will costrequire approximately $10$9.0 million in additional capital to: (1i) fund the FDA approval process to conduct human clinical trials; (2ii) conduct Phase I, pilot, and clinical trials; (3iii) activate several regional clinics to administer IsoPet® across the county; (4iv) create an independent production center within the current production site to create a template for future international manufacturing; and (5v) initiate regulatory approval processes outside of the United States.

The preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of financial statements and the reported amountsamount of revenuesrevenue and expensesexpense during the reporting period. Estimates the Company considers considers include criteria for stock-based compensation expense, and valuation allowances on deferred tax assets. Actual results could differ from those estimates.

In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606). This standard provides a single set of guidelines for revenue recognition to be used across all industries and requires additional disclosures. The updated guidance introduces a five-step model to achieve its core principle principal of the entity recognizing revenue to depict the transfer of goods or services to customers at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The Company adopted the updated guidance effective January 1, 2018 using the full retrospective method.

Under the FASB’s Accounting Standards Codification (“ASC”) Topic 606, in order to recognize revenue, the Company is required to identify an approved contract with commitments to preformperform respective obligations, identify rights of each party in the transaction regarding goods to be transferred, identify the payment terms for the goods transferred, verify that the contract has commercial substance and verify that collection of substantially all consideration is probable. The adoption of ASC 606 did not have an impact on the Company’s operations or cash flows.

The Company in 2024 also implemented a license program for clinics that pay for certification to perform these therapies. These revenues are recognized upon the certification being completed. DuringIn addition, due to a pricing discount from the yearmanufacturer, endedthe DecemberCompany 31,sold to 2024, $4,995two of their customers the revenuehydrogel relatesvials that are used in the treatments. This practice is not likely to this certification.be continued in future periods.

Vivos Inc. (the “Company,” “we,” “us,” or “our”) is a radiation oncology medical device company engagedfocused inon the development of its yttrium-90 (“Y-90”) based precision radionuclide therapy devices. ThisThese includesinclude RadioGel® Precision Radionuclide Therapy™ (Human Division) for treatingthe treatment of solid tumors and positive surgical margins in humanshumans, and IsoPet® (Animal Division) for treatingthe treatment of solid tumors and positive surgical margins in animals. The Company also sells PLGA-g-PEG polymers and PrecisionGel™, a hydrogel polymer platform designed for deliveringthe delivery of 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 20212021, the Company modified itsthe Indicationproposed indication for Useuse fromfor skin cancerRadioGel® to cancerousfocus tissue oron solid tumors pathologically associated with with locoregional papillary thyroid carcinoma and recurrent papillary thyroid carcinomacarcinoma, having discernable tumors associated withincluding metastatic lymph nodes or extranodal diseasedisease, 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.surgery.

Cumulative proceeds from these offerings have supported critical advancements, including Breakthrough Device designation (December 2023), ongoingU.S. FDA IDE resubmission preparations (with strengthened submission planned by endapproval of Q1the orEarly AprilFeasibility 2026Investigational Device Exemption (IDE), in July 2026, international human therapy data generation in in India, manufacturing diversification (new domestic facility at APEL in Richland, WA, and international site discussionsthrough 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 initiation of the FDA-approved Early Feasibility IDE submissionstudy andat potentialMayo approvalClinic forin clinicalJacksonville, trialsFL targeting non-resectable papillary thyroid carcinoma), 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 potentialthe FDAFDA’s July 2026 IDE clearanceapproval 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.period. 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 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 penetration for its Precision Radionuclide Therapy™ platform.

As of MarchJune 31,30, 2026, the Company had $2,525,782$2,336,022 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.

These allocations align with the Company’s priorities of achievingcontinuing breakevento close the profitability gap in the Animal Therapy DivisionDivision, inadvancing the 2026,now-approved securing FDAU.S. IDE clearance (withhuman resubmissionfeasibility targeted for end of Q1/April 2026),study, diversifying manufacturingmanufacturing, (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 precisionPrecision radionuclideRadionuclide therapyTherapy™ product line has been funded primarily with proceeds from the sale of equity and debt securities, including from theprior Regulation A+ Offerings. The Company requires additional funding of approximately $3.0 million annually to maintain its current level of operating activities. The Company continues to make progress with its IsoPet® animal therapy division, narrowing the profitability gap with the goal of eventually operating it as a self-sustaining, standalone business. 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 conductongoing FDA-approved human clinical trialsprogram and related activities; (ii) conduct Phasethe I,Early pilot,Feasibility study, subsequent pivotal trials, and other clinical trialsactivities; (iii) activate several regional clinics to administer IsoPet® across the U.S.United States; (iv) create an independent production center within the current production site to createserve as 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.

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 ofaffecting the Company’s spending and its financing requirements wouldwill be the timing of anyregulatory approvals and the nature of the Company’s arrangements with third parties for manufacturing, sales, distributiondistribution, and licensinglicensing, ofas thosewell products andas the products’commercial success of the products in the U.S.United States and elsewhere.other markets. The Company intends to fund its future activities through a combination of strategic transactions, transactions such as licensing and partnership agreementsagreements, or fromand proceeds raised from the Regulation A+ Offerings.Offerings and the IsoPet® division.

IsoPet® Animal Division

The Company selected Vista Veterinary Hospital in Kennewick, Washington (Tri-Cities area),Washington, as the pilot private clinic for initiatingcommercial commercial IsoPet® sales. This location facilitatedhas close collaboration with Company personnel to refine processes, servingserved as a model before nationalfor expansion.process refinement and regulatory compliance. Vista has successfully passed multiple audits by the Washington State Department of Health, withand the Company working closelycontinues alongsideto work with the Department to enhance thestrengthen radioactive material license by incorporating detailedmaterials licensing procedures that benefitcan be applied to future clinics. A second veterinarian at Vista has also been certified.

AnimalSafety therapy safety and efficacy data generated from IsoPet® treatments contributed positively to RadioGel®’s receiving Breakthrough Device Designation from the FDA and to support the Company’s FDA-approved Early Feasibility Investigational Device designation.Exemption (IDE) for the first-in-human clinical study.

As of DecemberJune 31,30, 2025,2026, the Company has 17 certified regional clinics nationwide,nationwide treating feline, canine, equine, and exotic animals:animals.

During 2025, the IsoPet® division achieved a reported 1,200% year-over-year increase in administered therapies, with overmore than 100 safe treatments (performed and zero reportable serious adverse events).events. The teamCompany launched a dedicated website for IsoPet®, staffed booths at sixmultiple industry conferences, and LeeAnna Binder conducted nationwide outreach viato asupport modified IsoPet®adoption. van.An Active social media managementabstract on Facebook,tumor Instagram,margin X,treatments using IsoPet® was accepted for presentation at the American College of Veterinary Surgeons (ACVS) conference. The Company is also utilizing data from multiple clinical studies for publication in peer-reviewed journals and LinkedInwill droveprovide engagementadditional anddetails websiteas traffic.more information becomes available.

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 does meet this criterion because it is a novel application of a precision radionuclide therapy device outside of the liver.” More 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 writing the Investigational Device Exemptions (“IDEs”) and saved the Company much time in the review of that future application.

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™RadioGel® to treat recurrent thyroid cancer and to answer a range of questions from the new 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.

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.

After providing additionadditional information to the FDA on December 18, 2023, the FDA classified us as a Breakthrough device to our proposed Indication for Use.

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.

The Medical Advisory Board (“MAB”) selected 18 applications for RadioGel™®, each of which meet the criteria described described above. This large number confirms the wide applicability of the device and defines the path for future business growth. The Company’s 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.

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 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.

A pre-submission meeting (Q140496) was held with the FDA on June 17, 2014, during which the FDA maintained that RadioGel™® should should be considered a Class III device and therefore subject to pre-market approval. On December 29, 2014, the Company submitted a de novo 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 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.