Investor Relations

Vivos and RadioGel® have reached an important regulatory milestone with FDA approval authorizing the RadioGel® clinical study to proceed. This approval marks meaningful progress toward initiating the first-in-human evaluation of the technology. The study is now progressing through Mayo Clinic’s required institutional review (IRB) and activation process before patient enrollment can begin. These are important and customary steps for initiating a first-in-human clinical study at a major medical institution and can take several months.

FDA IDE approval → Mayo institutional submission/review → IRB approval → final study activation → recruitment/enrollment → first patient treated

Each completed step moves Vivos and RadioGel® closer to the initiation of the first-in-human study. We appreciate your patience while we navigate the next steps. Information on IDE and Mayo progress will be shared as it becomes available.

We understand shareholders want answers and appreciate the urgency. Advancing a first-in-human clinical trial through a major institution such as Mayo Clinic involves multiple regulatory, institutional and operational steps that take time. The process is moving forward, and the passage of time should not be interpreted as a negative development. Vivos will provide material updates when they are appropriate and available for public disclosure.

No. After the study is activated, Mayo Clinic and its clinical team will identify, evaluate, and enroll eligible patients under the approved protocol, including informed consent. Vivos does not independently select or enroll patients. Material enrollment or treatment milestones will be shared when they are available for public disclosure.

Vivos cannot provide a specific treatment date at this time. Timing depends on completion of Mayo Clinic’s remaining institutional requirements, study activation, and identification of an eligible patient. Material treatment milestones will be shared when they are available for public disclosure.

This is a small initial feasibility study. Timing will depend on Mayo Clinic study activation, enrollment of eligible patients, treatment, and required follow-up. First patient treatment and full study completion are separate milestones. Vivos will share material updates when they are available for public disclosure.

Vivos will communicate material clinical milestones when they can be publicly disclosed. This study is conducted through Mayo Clinic, so patient privacy, informed consent, and Mayo’s clinical research procedures must be respected. Public updates will focus on study milestones and aggregate results, not individual patients or patient-by-patient reporting.

The RadioGel® study is a small five-patient feasibility study being conducted through Mayo Clinic and is still moving through Mayo’s institutional review and activation process. Whether and when the study is listed on ClinicalTrials.gov will be determined by applicable requirements and Mayo Clinic procedures. If the study is publicly listed, Vivos will share that information.

The RadioGel® feasibility study will be conducted at Mayo Clinic under the FDA-approved protocol. Mayo Clinic investigators and the clinical research team will manage day-to-day study conduct, including institutional review and activation, patient eligibility, informed consent, treatment, monitoring, and follow-up. Vivos supports the study as the developer and manufacturer of RadioGel® and fulfills its responsibilities under the approved IDE.

Vivos continues to advance RadioGel® human therapy development in India. The research study has provided important clinical experience, including favorable safety observations from patients treated to date. As previously disclosed, activity was temporarily paused as part of a broader institutional review unrelated to RadioGel® or the reported results. Existing Ethics Committee and registry approvals remain in place. Vivos is working with its India regulatory team toward resumption of the research study and the additional approvals needed for the next stage of development.

No. The temporary pause was related to broader institutional and regulatory matters and was not related to RadioGel® or the reported results. Vivos has previously reported favorable safety observations from patients treated in India. Detailed individual patient information cannot be disclosed.

Vivos is not providing a specific restart date at this time. The Company is working with its India regulatory team toward resumption of the research study and is advancing the additional approvals needed for the next stage of development. In parallel, Vivos received authorization from India’s Atomic Energy Regulatory Board (AERB) to proceed with an international manufacturing center in India. That manufacturing authorization supports future clinical and commercial programs; it is separate from the timing of treatment resumption. Material updates will be shared when they are available for public disclosure.

As reported in Vivos’ August 2026 corporate update, 12 patients have been treated with RadioGel® in the India research study. Earlier updates reflected the totals at those earlier stages of the study. The most current publicly reported total is 12 patients.

The treatment itself is only one part of the evaluation. Meaningful results depend on scheduled follow-up so physicians can assess safety, tumor response, and durability over time. Vivos has previously reported safety observations from patients treated in India and will share additional study-level findings when they are available for public disclosure. Any scientific publication is a separate process and would follow completion of the required follow-up, data analysis, and peer review.

Vivos currently has 10 certified small-animal veterinary clinics and five university partners. Additional clinics are in the certification process, but they are not included in the certified total until all requirements are complete. Because IsoPet® uses radioactive material, each clinic must finish the required state licensing, training, and certification. Depending on the state, that process can take about 3 to 18 months.

An IsoPet® partner must complete radioactive-materials licensing, specialized training, and certification. Those requirements vary by state, so a clinic can be in onboarding for some time before it is fully certified. Clinics are added to the certified total only after all requirements are complete.

More than 200 animals have been treated with IsoPet® to date. Vivos will provide additional program updates when they are available for public disclosure.

Vivos shares IsoPet® treatment stories when owner consent and clinic approval are in place. As the manufacturer, we respect client confidentiality and each clinic’s policies, so not every case can be posted. When permissions and photos are available, we will share additional treatment stories from our veterinary partners.

IsoPet® remains in a commercial growth stage. Vivos has been expanding the certified clinic network, supporting clinic licensing and training, treating patients, and collecting clinical data. The Company is also investing in abstracts and publications so that study results and clinical findings can be shared with the broader veterinary community. Those publications are intended to support awareness, veterinarian confidence, and longer-term adoption. These growth activities add cost before the program reaches scale. Reported revenue for this period may not fully reflect treatment activity, depending on study cases, timing, and how treatments are billed. Bringing production in-house at APEL is meant to improve supply control and support additional clinics as volume grows. IsoPet® is not yet profitable because the Company is still investing in manufacturing, certification, network expansion, and clinical publication work ahead of broader commercial scale.

The Exubrion Therapeutics relationship supports IsoPet® adoption by giving veterinary clinics more ways to use a radioactive materials license. Both IsoPet® and Synovetin OA® require a RAM license, which involves ongoing clinic commitment and annual cost. Offering two therapies under that same infrastructure can make the license more useful to the practice. In many cases, a clinic that already holds a RAM license for one of these modalities can pursue an amendment rather than a new license, which can reduce approval time compared with starting from scratch.

Vivos evaluates strategic opportunities that could strengthen manufacturing, logistics, and distribution in the U.S. and internationally as demand grows. That may include relationships that support scale, reliability, and access. The Company does not comment on potential partnerships or discussions unless there is something material to disclose.

APEL in Richland, Washington gives Vivos direct control over U.S. production of IsoPet® and is intended to support future RadioGel® manufacturing needs. Bringing production in-house is meant to improve supply reliability, quality oversight, and the ability to serve additional clinics as volume grows. Vivos has begun shipping IsoPet® from APEL to certified clinics. APEL is Vivos’ U.S. production site and is separate from the Company’s planned international manufacturing center in India.

Vivos does not control the market price of its common stock. Price can be affected by trading activity, market conditions, liquidity, and investor expectations. Management remains focused on advancing RadioGel®, growing IsoPet®, and executing the Company’s strategy.

As a public company, Vivos reports required information in its SEC filings and discloses material developments when they can be shared publicly. Many regulatory, clinical, and business-development matters involve confidential processes and third parties, so there are periods when more detail cannot be released. Updates are issued through press releases, filings, the Company website, and social media when there is material information to share. Shareholder questions can be sent to investors@vivosinc.com; material news is disclosed publicly rather than through individual correspondence.

Vivos continually evaluates the resources needed to support investor relations, business development and commercialization. Personnel or partnership announcements will be made if and when they become material.

Vivos evaluates the resources needed to support investor relations, business development, and commercialization. Any personnel or partnership announcement will be made if and when it is material.

Yes. Vivos expects to hold its Annual Meeting of Stockholders in the fourth quarter of 2026. A specific date has not yet been finalized. Once confirmed, the date, time, and meeting details will be communicated through the appropriate corporate and regulatory channels.

Send investor-related questions to investors@vivosinc.com. Centralizing inquiries helps Vivos respond consistently and identify recurring topics that may belong on the FAQ. Material developments are disclosed publicly and are not provided through individual correspondence.

Material information will be communicated through public disclosure channels so all shareholders have access to the same information. Investor Relations will not provide selective material updates to individual shareholders. Questions can be sent to investors@vivosinc.com; material news will still be disclosed publicly.