10-Q: Vivos Inc. Q2 2026: Regulatory Progress Amidst Financial Concerns

Vivos Inc. reports progress on FDA approvals for its RadioGel therapy and growth in its IsoPet animal division, but continues to face significant net losses and concerns about its going concern status.

Summary

• Vivos Inc. filed its Form 10-Q for the quarterly period ended June 30, 2026.
• The company reported revenues of $72,468 for the six months ended June 30, 2026, an increase from $41,748 in the prior year period.
• Net loss for the six months ended June 30, 2026, was $2,015,034, compared to a net loss of $1,480,209 for the same period in 2025.
• As of June 30, 2026, the company had $2,336,022 in cash.
• The company received U.S. FDA approval for its Early Feasibility Investigational Device Exemption (IDE) in July 2026 for the first-in-human clinical feasibility study of RadioGel.
• The IsoPet animal therapy division showed significant growth, with over 100 treatments administered and zero reportable serious adverse events.
• The company's independent registered public accounting firm has expressed substantial doubt about its ability to continue as a going concern.

Sentiment

Score: 3

Explanation: StockSavvy.ai views this filing as having a negative sentiment due to the company's continued net losses, substantial doubt about its ability to continue as a going concern, and significant cash burn, despite progress in regulatory approvals and product development.

Positives

• Received U.S. FDA approval for the Early Feasibility Investigational Device Exemption (IDE) in July 2026 for the first-in-human clinical feasibility study of RadioGel Precision Radionuclide Therapy.
• The IsoPet animal therapy division experienced substantial growth, with a 1,200% year-over-year increase in administered therapies in 2025 and over 100 treatments performed with zero reportable serious adverse events as of June 30, 2026.
• The company secured a Washington State Radioactive Materials License for its new in-house production facility.
• U.S. Patent No. 12,521,452 B2, titled Radiotherapy Gel and Method of Preparing the Same, was issued on January 13, 2026, protecting advancements in the PRnT platform.
• Revenue increased to $72,468 for the six months ended June 30, 2026, from $41,748 in the prior year period.
• Cash position increased to $2,336,022 as of June 30, 2026, from $1,558,525 as of December 31, 2025.

Negatives

• The company incurred a net loss of $2,015,034 for the six months ended June 30, 2026, an increase from $1,480,209 in the prior year period.
• The company's independent registered public accounting firm has expressed substantial doubt about its ability to continue as a going concern.
• Operating expenses for the six months ended June 30, 2026, were $1,190,283, while revenues were only $72,468, indicating a significant operational deficit.
• A loss of $847,628 was recorded on the exchange of shares and warrants during the six months ended June 30, 2026.
• The company requires approximately $3.0 million annually to maintain current operating activities and estimates needing $9.0 million over the next 36 months for continued development and operations.
• The company reported a gross loss of $9,738 for the six months ended June 30, 2026.

Risks

• The company has suffered recurring losses and used significant cash in support of its operating activities, raising substantial doubt about its ability to continue as a going concern.
• If the Company cannot obtain sufficient additional capital, it will be required to delay the implementation of its business strategy and may not be able to continue operations.
• The company's current level of cash is insufficient to cover fixed and variable obligations.
• The introduction of competitive products could significantly reduce sales, adversely impacting financial and operating results.
• Noncompliance with applicable FDA regulations can result in civil penalties, recall, injunction or seizure of products, refusal of government approval, and criminal prosecution.
• The company is subject to extensive laws and regulations governing medical devices and radioactive materials, requiring compliance with federal, state, and local authorities.

Future Outlook

The company requires additional funding of approximately $3.0 million annually to maintain current operating activities and estimates needing approximately $9.0 million over the next 36 months for human clinical trials, activating regional clinics, creating an international production center, and initiating regulatory approval processes outside the U.S. Future spending will be influenced by FDA approval timelines, pivotal trial progress, and international regulatory submissions. The company intends to fund future activities through strategic transactions, licensing/partnership agreements, and proceeds from Regulation A+ Offerings and the IsoPet division.

Management Comments

• Management does not anticipate that the Company will generate sufficient revenue to sustain operations until such time as the Company secures multiple revenue-generating arrangements with respect to RadioGel and/or any of our other brachytherapy technologies.
• The Company requires additional funding of approximately $3.0 million annually to maintain its current level of operating activities.
• Over the next 36 months, the Company believes it will require approximately $9.0 million in additional capital to fund various development and operational initiatives.
• The Company intends to fund its future activities through a combination of strategic transactions, such as licensing and partnership agreements, and proceeds from Regulation A+ Offerings and the IsoPet division.

Industry Context

StockSavvy.ai notes that Vivos Inc. operates in the competitive radiation oncology medical device sector, focusing on precision radionuclide therapy. The company's progress with FDA approvals for its RadioGel product and the commercialization of its IsoPet veterinary product align with industry trends towards targeted therapies. However, the significant financial challenges and the ongoing need for substantial capital raise highlight the high-risk, high-reward nature of early-stage medical device development.

Comparison to Industry Standards

• The company's RadioGel product competes in the brachytherapy market against established players like GE Healthcare (Oncura) and C.R. Bard, who utilize Iodine-125 (I-125) and Palladium-103 (Pd-103) technologies.
• Other Y-90 therapies, such as SIR-Spheres by Sirtex and TheraSphere by Biocompatibles UK, are FDA-approved and represent direct competitors in the radionuclide therapy space.
• The company's approach of using a hydrogel that perfuses into the tumor before gelation (BetaGelTM/RadioGel) differs from products like Beta-Glue, which forms a bolus upon injection.
• The veterinary market for IsoPet faces competition from various cancer treatment modalities for companion animals, though Vivos highlights IsoPet's advantage of not requiring an on-site oncologist.

Legal Proceedings

• The Company may, from time to time, be involved in various legal proceedings incidental to the conduct of its business. Historically, the outcome of all such legal proceedings has not, in the aggregate, had a material adverse effect on its business, financial condition, results of operations or liquidity.

Related Party Transactions

• In February 2026, the Chief Executive Officer advanced $5,350 to the Company, which was repaid within six days.

Stakeholder Impact

• Shareholders face continued dilution risk from ongoing capital raises and the potential for further stock issuances to fund operations.
• The company's ability to continue as a going concern poses a significant risk to all stakeholders, including investors and employees.
• Creditors and suppliers may face uncertainty regarding timely payments due to the company's financial condition.
• Patients (human and animal) and healthcare providers may benefit from the potential future availability of novel cancer therapies if regulatory and financial hurdles are overcome.

Next Steps

• Initiate the first-in-human clinical feasibility study for RadioGel Precision Radionuclide Therapy at Mayo Clinic in Jacksonville, FL, following FDA IDE approval.
• Continue advancing clinical activities and pursuing expanded regulatory clearances in India through the Drugs Controller General of India (DCGI).
• Establish an international production facility in India to support clinical trials and commercialization efforts.
• Continue to grow the U.S. certified clinic network for IsoPet and explore international market opportunities.
• Construct and validate two new production facilities (one domestic in Richland, Washington, and one international) for RadioGel manufacturing.
• Seek partnerships in additional countries to expand clinical trials and support future FDA Premarket Authorization (PMA) submissions.
• Present an accepted abstract on tumor margin treatments at the American College of Veterinary Surgeons (ACVS) in 2026.
• Ship product from the new in-house production facility in Washington State.

Key Dates

Recommendation

The company shows promising regulatory progress and growth in its veterinary division, but the significant net losses, substantial doubt about its going concern status, and ongoing need for capital present considerable risks. A 'hold' recommendation reflects the speculative nature of the investment, balancing potential upside from regulatory approvals against the high probability of continued financial challenges and potential dilution.

Keywords

Precision Radionuclide Therapy, RadioGel, IsoPet, Brachytherapy, Oncology, Medical Device, FDA Approval, Clinical Trials