10-K: Vivos Inc. Reports Annual Results for 2024, Highlights Progress in Radionuclide Therapy Development

Vivos Inc.'s 2024 annual report details ongoing efforts in developing its RadioGel technology and expanding its IsoPet veterinary services, despite facing financial challenges and expressing doubt about its ability to continue as a going concern.

Summary

• Vivos Inc. is a radiation oncology medical device company focused on developing RadioGel, a Y-90 based precision radionuclide therapy for non-resectable tumors.
• The FDA has classified RadioGel as a device for human therapy and animal therapy.
• The company markets RadioGel as IsoPet for veterinary use to avoid confusion with human therapy.
• In January 2025, the company restructured to align resources with animal therapy, human therapy, and other applications of its technologies.
• The company has worked with multiple national laboratories and veterinary hospitals to test IsoPet/RadioGel, confirming the Y-90 stays at the injection site.
• The first commercial sale of IsoPet occurred in July 2019.
• The company plans to derive near-term profits from direct sales of IsoPet and certifying veterinary clinics.
• In December 2023, RadioGel received Breakthrough Device designation from the FDA.
• The company is actively pursuing human clinical trials in India.
• The company is exploring other business opportunities, including Peltier Chiller technology and hydrogel applications.
• The company has expanded its trademark and patent protection.
• The company is expanding the number of IsoPet certified clinics, targeting approximately ten more in 2025.
• The company is working to refine its pricing to make services more affordable for pet patients.
• The company requires approximately $3.5 million per year for Selling and General Administration costs.
• The company estimates it will cost approximately $10 million over the next 36 months to conduct human clinical trials, activate regional clinics, and create an alternate manufacturing center.
• As of December 31, 2024, the company has $2,212,548 cash on hand.
• The company's independent registered public accounting firm has expressed substantial doubt about the company's ability to continue as a going concern.
• The company had a net loss of $2,910,448 for the year ended December 31, 2024, and a net loss of $2,894,753 for the year ended December 31, 2023.

Sentiment

Score: 4

Explanation: The document presents a mixed sentiment. While there are positive developments regarding FDA designations and clinical trials, the financial situation and going concern warning significantly weigh down the overall outlook.

Positives

• RadioGel received Breakthrough Device designation from the FDA, which should expedite the review process.
• The company is actively pursuing human clinical trials in India, expanding its reach and potential market.
• The company is expanding its IsoPet certified clinic network, increasing accessibility to its veterinary services.
• The company is exploring additional business opportunities related to its Peltier Chiller technology and hydrogel, diversifying its revenue streams.
• The company has $2,212,548 cash on hand as of December 31, 2024.

Negatives

• The company's independent registered public accounting firm has expressed substantial doubt about the company's ability to continue as a going concern.
• The company has limited revenue and has accumulated deficits since inception.
• The company had a net loss of $2,910,448 for the year ended December 31, 2024, and a net loss of $2,894,753 for the year ended December 31, 2023.
• The company requires approximately $3.5 million per year for Selling and General Administration costs, placing a strain on its limited resources.

Risks

• The company's independent registered public accounting firm has expressed substantial doubt about the company's ability to continue as a going concern.
• The company has limited revenue and has accumulated deficits since inception.
• The company may not be able to obtain sufficient additional capital to continue its operations.
• The company's products are regulated and require appropriate clearances and approvals to be marketed in the U.S. and globally.
• The company is dependent on consultants for many of the services necessary to continue operations.
• The company currently relies on a single supplier for Y-90 particles, and that supplier is the only supplier in the United States.
• The company relies on a sole manufacturing contact with IsoTherapeutics.
• The company may incur material losses and costs because of product liability claims that may be brought against it.
• The company is subject to uncertainties regarding reimbursement for use of its products.
• The company's stock price is likely to be volatile.

Future Outlook

The company intends to fund its activities through strategic transactions such as licensing and partnership agreements or additional capital raises. The company estimates it will cost approximately $10 million over the next 36 months to conduct human clinical trials, activate regional clinics, and create an alternate manufacturing center.

Management Comments

• 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 Companys Medical Advisory Board felt that demonstrating efficacy in clinical trials with this new indication provided a more efficient pathway to regulatory clearance.

Industry Context

The company competes in a market characterized by technological innovation, extensive research efforts, and significant competition. The pharmaceutical and biotechnology industries are intensely competitive and subject to rapid and significant technological changes.

Comparison to Industry Standards

• The Companys Radiogel precision radionuclide therapy product would generally compete with brachytherapy devices currently marketed in the U.S. and globally.
• The traditional iodine-125 (I-125) and palladium-103 (Pd-103) technologies are well entrenched with powerful market players.
• The industry-standard I-125-based therapy was developed by Oncura, which is a unit of General Electric Healthcare.
• Additionally, C.R. Bard, a major industry player competes in the I-125 marketplace.
• Cs-131 brachytherapy products are marketed by GT MedTech.
• Several Y-90 therapies have been FDA approved including SIR-Spheres by Sirtex, TheraSphere by Biocompatibles UK.

Stakeholder Impact

• Shareholders face significant risk due to the company's financial instability.
• Employees' job security is uncertain due to the company's going concern warning.
• Customers (veterinarians and pet owners) may benefit from the expansion of IsoPet services, but the long-term availability of the product is uncertain.
• Suppliers and creditors face the risk of non-payment if the company's financial situation does not improve.

Next Steps

• Continue to pursue FDA approval for RadioGel.
• Expand the IsoPet certified clinic network.
• Pursue human clinical trials in India.
• Explore additional business opportunities related to Peltier Chiller technology and hydrogel applications.
• Seek additional funding to maintain operations.

Key Dates

Keywords

RadioGel, IsoPet, Radionuclide Therapy, Y-90, Cancer Treatment, Veterinary Oncology, Clinical Trials, FDA Approval, Medical Device, Tumors