10-Q: Vivos Inc. Q1 2026 Update: Revenue Growth, Strategic Expansion

Vivos Inc. reports increased revenue and strategic advancements in its precision radionuclide therapy for both human and animal oncology, alongside ongoing financing efforts.

Summary

• Vivos Inc. reported revenues of $36,068 for the three months ended March 31, 2026, an increase from $26,748 in the same period of 2025.
• The company experienced a gross loss of $8,018 for Q1 2026, an improvement from a gross loss of $9,083 in Q1 2025.
• Total operating expenses decreased significantly to $537,474 in Q1 2026 from $854,449 in Q1 2025, primarily due to lower professional fees and stock-based compensation.
• The net loss for Q1 2026 was $1,184,845, compared to a net loss of $834,696 for Q1 2025.
• Cash on hand increased to $2,525,782 as of March 31, 2026, from $1,558,525 as of December 31, 2025.
• The company raised $2,203,800 in March and April 2026 through its Regulation A+ Offering and concurrent private placement of warrants.
• Vivos Inc. is actively pursuing FDA approval for its RadioGel human therapy and expanding its IsoPet animal therapy business, with plans for international expansion in India.
• The company is working to establish new domestic and international production facilities, with the goal of operational readiness in 2026.
• Substantial doubt exists regarding the company's ability to continue as a going concern, necessitating further capital raises and operational improvements.

Sentiment

Score: 3

Explanation: StockSavvy.ai views this as a negative sentiment due to the increased net loss, significant warrant exchange loss, and continued going concern doubts, despite some revenue growth and strategic progress.

Positives

• Revenue increased by 34.8% to $36,068 in Q1 2026 compared to $26,748 in Q1 2025.
• Gross loss improved to $8,018 in Q1 2026 from $9,083 in Q1 2025.
• Operating expenses decreased by 35.5% to $537,474 in Q1 2026 from $854,449 in Q1 2025, driven by reduced professional fees and stock-based compensation.
• Cash position strengthened, with cash on hand increasing to $2,525,782 as of March 31, 2026.
• Successful capital raise of $2,203,800 in March/April 2026 through Regulation A+ Offering and warrant placements.
• The IsoPet Animal Therapy Division reported a 1,200% year-over-year increase in administered therapies from 2024 to 2025.
• Over 100 IsoPet treatments administered with zero reportable serious adverse events.
• U.S. Patent No. 12,521,452 B2 for Radiotherapy Gel and Method of Preparing the Same was issued on January 13, 2026.
• Breakthrough Device designation for RadioGel by the FDA in December 2023.
• Plans to establish domestic and international production facilities in 2026 to mitigate supply chain risks.

Negatives

• The company incurred a net loss of $1,184,845 in Q1 2026, an increase from $834,696 in Q1 2025.
• A loss of $651,628 was recorded on the exchange of warrants in Q1 2026.
• The company has recurring losses and has accumulated deficits since inception, raising substantial doubt about its ability to continue as a going concern.
• The FDA rejected the company's IDE submission on August 13, 2025, requiring further work and resubmission.
• The company requires significant additional capital, estimated at $3 million annually and $9 million over the next 36 months, to fund operations and development.
• The company's current cash position is insufficient to cover fixed and variable obligations.
• Disclosure controls and procedures were found to be ineffective due to material weaknesses in proper segregation of duties.

Risks

• Substantial doubt exists regarding the company's ability to continue as a going concern due to recurring losses, accumulated deficits, and insufficient cash.
• The company's future success is dependent on securing adequate funding, obtaining regulatory approvals for RadioGel, and successfully commercializing its products.
• The FDA's classification of RadioGel as a Class III device subjects it to stringent regulatory review and pre-market approval requirements.
• The company faces intense competition in the medical device and biotechnology industries.
• Reliance on third-party manufacturers for production poses supply chain risks, although diversification efforts are underway.
• The company's ability to execute its business plan may be impacted by recent geopolitical events and volatility in global capital markets.
• The company's disclosure controls and procedures were found to be ineffective due to material weaknesses in proper segregation of duties.

Future Outlook

The company anticipates continued net operating losses in the foreseeable future. Success hinges on securing additional capital, obtaining FDA approval for RadioGel, and successfully commercializing its products. The company aims for breakeven in the Animal Therapy Division in 2026 and requires approximately $9.0 million in additional capital over the next 36 months for FDA approval processes, clinical trials, clinic activation, production center creation, and international regulatory processes.

Management Comments

• Vivos Inc. believes that it is important to communicate its future expectations to its investors.
• The Company urges you to be cautious of the forward-looking statements which are contained in this Quarterly Report because they involve risks, uncertainties and other factors affecting its operations, market growth, service, products and licenses.
• 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.
• The Company requires additional funding of approximately $3.0 million annually to maintain operating activities.
• 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.

Industry Context

StockSavvy.ai notes that Vivos Inc. operates in the highly competitive radiation oncology and medical device sector. The company's focus on radionuclide therapy, particularly with Y-90, places it in a niche but growing area of cancer treatment. The company's dual approach of targeting both human and animal oncology markets is a strategic diversification, leveraging the regulatory pathway for veterinary devices to gain market traction while pursuing the more complex FDA approval for human applications. The company's progress in securing intellectual property and advancing its IDE submission for RadioGel are critical milestones in this landscape.

Comparison to Industry Standards

• Traditional brachytherapy competitors like Oncura (GE Healthcare) and C.R. Bard utilize Iodine-125 (I-125) and Palladium-103 (Pd-103) technologies, which are well-established in the market.
• GT MedTech markets Cesium-131 (Cs-131) brachytherapy products.
• FDA-approved Y-90 therapies like SIR-Spheres by Sirtex and TheraSphere by Biocompatibles UK represent direct competitors in the Y-90 space.
• Vivos Inc.'s RadioGel aims to differentiate itself through its localized beta emission, short half-life, and gel resorption properties, potentially offering advantages in precision and patient safety compared to existing brachytherapy options.

Corporate Governance

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: Continued net losses and going concern doubts may impact stock value. Successful capital raises and regulatory approvals are critical for future value creation.
• Employees: The company's financial situation and operational focus may create uncertainty. The addition of a President role indicates potential for organizational growth.
• Creditors: The company's ability to meet its obligations is dependent on future financing and operational improvements.
• Customers (Veterinary Clinics): Continued expansion of the IsoPet network and potential profitability in the division could lead to increased service offerings and support.
• Customers (Human Healthcare Providers): Progress towards FDA approval for RadioGel is crucial for future adoption and market penetration.

Next Steps

• Continue efforts to obtain FDA approval for RadioGel human therapy.
• Resubmit IDE application for RadioGel.
• Expand IsoPet animal therapy business and achieve breakeven in 2026.
• Establish domestic and international production facilities.
• Secure additional financing to support operations and development.
• Conduct human clinical trials in the U.S. and India.
• Pursue regulatory approval processes outside of the U.S.

Key Dates

Recommendation

Vivos Inc. shows promising progress in its core technologies (RadioGel and IsoPet) and has secured key intellectual property and regulatory designations (Breakthrough Device). However, the significant increase in net loss, substantial loss from warrant exchanges, and the continued doubt about the company's ability to continue as a going concern present considerable risks. The company's reliance on future capital raises and the lengthy FDA approval process for RadioGel warrant a cautious approach. While the potential upside is considerable if regulatory and commercialization hurdles are overcome, the current financial instability and execution risks suggest a 'hold' recommendation pending clearer signs of financial stability and regulatory progress.

Keywords

Vivos Inc., RadioGel, IsoPet, Precision Radionuclide Therapy, Oncology, Medical Device, Veterinary Therapy, FDA Approval, IDE Submission, Regulation A+, Capital Raise, Brachytherapy, Yttrium-90