10-Q: Vivos Inc. Q3 2026: Progress Amidst Financial Concerns

Vivos Inc. reports Q3 2026 progress in its dual-track development of animal and human cancer therapies, but faces ongoing financial challenges and auditor concerns about its going concern status.

Summary

• Vivos Inc. filed its Q3 2026 Form 10-Q, detailing financial results and operational updates for the period ending September 30, 2026.
• The company reported revenues of $101,368 for the nine months ended September 30, 2026, an increase from $43,627 in the prior year period, primarily from IsoPet therapies and sales.
• Net loss for the nine months ended September 30, 2026, was $2,746,628, compared to a net loss of $1,987,503 for the same period in 2025.
• As of September 30, 2026, the company had $1,807,350 in cash, but faces substantial doubt regarding its ability to continue as a going concern due to recurring losses and insufficient cash to support operations.
• Significant progress was made in regulatory pathways, including FDA approval of the Early Feasibility IDE for RadioGel human trials and continued development in India.
• The IsoPet animal therapy division showed growth, with over 100 treatments administered and zero reportable serious adverse events, aiming for breakeven in 2026.
• The company is actively seeking additional capital, estimating a need of approximately $9.0 million over the next 36 months for clinical trials, operational expansion, and international development.

Sentiment

Score: 3

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

Positives

• Revenue increased to $101,368 for the nine months ended September 30, 2026, up from $43,627 in the prior year, driven by IsoPet therapies and sales.
• The IsoPet animal therapy division demonstrated significant growth, with over 100 treatments administered and zero reportable serious adverse events.
• Received U.S. FDA approval for the Early Feasibility Investigational Device Exemption (IDE) for the first-in-human clinical feasibility study of RadioGel.
• Established a new in-house production facility (APEL) in Washington State, receiving a Radioactive Materials License and beginning shipments in August 2026.
• Received authorization from India's Atomic Energy Regulatory Board (AERB) to proceed with an international manufacturing center.
• Secured U.S. Patent No. 12,521,452 B2 protecting advancements in the PRnT platform.
• The company is working towards achieving breakeven in the Animal Therapy Division in 2026.

Negatives

• Reported a net loss of $2,746,628 for the nine months ended September 30, 2026, an increase from $1,987,503 in the prior year period.
• The company has an accumulated deficit of $91,173,874 as of September 30, 2026.
• The independent registered public accounting firm has expressed substantial doubt about the company's ability to continue as a going concern.
• Cash position of $1,807,350 as of September 30, 2026, is insufficient to cover fixed and variable obligations for continued product development.
• A loss of $847,628 was recorded in 2026 related to the issuance of shares and warrant exchange.
• Operating expenses increased in the three-month period ended September 30, 2026, to $770,300 from $518,208 in the prior year period.

Risks

• The company has recurring losses and a history of operating deficits, raising substantial doubt about its ability to continue as a going concern.
• The company requires significant additional capital, estimated at $3.0 million annually and $9.0 million over the next 36 months, to fund operations, clinical trials, and expansion.
• Failure to secure adequate funding could lead to delays in implementing its business strategy or cessation of operations.
• Regulatory approvals for RadioGel and other brachytherapy products are critical for future commercialization and revenue generation.
• The introduction of competitive products could significantly reduce sales and adversely impact financial results.
• The company is subject to extensive government regulation, including FDA requirements for medical devices, which can be lengthy and resource-intensive.
• The company's ability to execute its business plan may be impacted by recent geopolitical events and volatility in global capital markets.

Future Outlook

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 FDA approval processes, clinical trials, clinic activation, production center creation, and international regulatory approvals. Future funding is expected from strategic transactions, licensing, partnerships, and Regulation A+ Offerings. The company anticipates continued net operating losses in the foreseeable future.

Management Comments

• The Company requires funding of approximately $3 million annually to maintain current 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 expansion initiatives.
• Based on the Companys financial history since inception, the Companys independent registered public accounting firm has expressed substantial doubt as to the Companys ability to continue as a going concern.
• 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.

Industry Context

StockSavvy.ai notes that Vivos Inc. operates in the competitive radiation oncology and medical device sector, facing established players in brachytherapy. The company's focus on novel Y-90 based therapies for both human and veterinary oncology positions it in a growing but highly regulated market.

Comparison to Industry Standards

• The company's RadioGel product competes with established brachytherapy devices using Iodine-125 (I-125) and Palladium-103 (Pd-103), marketed by major players like GE Healthcare (Oncura) and C.R. Bard.
• Cesium-131 (Cs-131) brachytherapy products are marketed by GT MedTech.
• Other Y-90 therapies, such as SIR-Spheres by Sirtex and TheraSphere by Biocompatibles UK, are FDA-approved and compete in the market.
• The company's approach of using a hydrogel carrier (PrecisionGel) for localized beta radiation delivery aims to differentiate from competitors like Beta-Glue, which forms a bolus.
• The veterinary market for IsoPet addresses a significant need, with approximately 6 million canine cancer diagnoses annually in the U.S. pet population exceeding 163 million dogs and cats.

Legal Proceedings

• The company may be involved in various legal proceedings incidental to its business, but historically, the outcome of such proceedings has not had a material adverse effect.

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 due to ongoing capital raises and the company's need for significant future funding.
• The company's ability to continue operations is dependent on securing additional financing, impacting all stakeholders.
• Employees and consultants may be affected by the company's financial condition and its ability to sustain operations.
• Customers (veterinary clinics and potentially future human healthcare providers) rely on the company's product development and regulatory approvals for continued access to therapies.

Next Steps

• Continue advancing the FDA-approved Early Feasibility IDE human feasibility study at Mayo Clinic.
• Scale IsoPet commercialization with the goal of achieving breakeven in the Animal Therapy Division in 2026.
• Support Vivos Scientific India LLP (VSIL) initiatives for local manufacturing and clinical trials in India.
• Mitigate single-site production risks through multi-facility operations (targeted for 2026 readiness).
• Pursue broader global access to the Precision Radionuclide Therapy platform.
• Continue research on additional products and technologies to improve cancer diagnosis and treatment.
• Host the 2026 Annual Meeting on December 9, 2026, with votes on board approval, the 2026 Omnibus Securities and Incentive Plan, and the independent registered public accounting firm.

Key Dates

Recommendation

StockSavvy.ai recommends a 'hold' rating. While Vivos Inc. shows promising progress in its product development (RadioGel human trials, IsoPet growth) and regulatory approvals (FDA IDE), the significant net losses, substantial accumulated deficit, and the auditor's substantial doubt about the company's going concern status present considerable risks. The company's future is heavily reliant on securing substantial additional funding, which introduces significant uncertainty. Investors should monitor progress on clinical trials, regulatory milestones, and the company's ability to secure necessary financing before considering a more aggressive stance.

Keywords

Radiation Oncology, RadioGel, IsoPet, Precision Radionuclide Therapy, Medical Device, Cancer Treatment, Veterinary Oncology, Yttrium-90