10-K: Vivos Inc. Reports on Progress in RadioGel Development and Veterinary Market Expansion in Annual 10-K Filing

Vivos Inc.'s annual report details the company's focus on its RadioGel technology for cancer treatment, progress in the veterinary market with IsoPet, and ongoing efforts to secure FDA approval for human trials.

Summary

• Vivos Inc. is a radiation oncology medical device company focused on developing RadioGel, a Y-90 based brachytherapy device for treating non-resectable tumors.
• The company has shifted its primary focus to the veterinary market with IsoPet, a version of RadioGel for animal therapy, and has established regional clinics for treatment.
• Vivos is working towards FDA approval for RadioGel as a Class II medical device for human use, initially targeting papillary thyroid carcinoma.
• The company has expanded its intellectual property portfolio, including patents for its Y-90 phosphate particles and hydrogel technology.
• Vivos has raised approximately $6 million through Regulation A+ offerings and is seeking additional funding to support clinical trials and commercialization.
• The company reported a net loss of $2,894,753 for the year ended December 31, 2023, and has an accumulated deficit of $82,450,781.
• Vivos has $1,592,287 in cash on hand as of December 31, 2023, and requires additional funding to maintain operations and pursue its business strategy.

Sentiment

Score: 4

Explanation: The document highlights both positive developments, such as progress in the veterinary market and intellectual property expansion, and significant challenges, including financial losses, going concern issues, and dependence on a single supplier. The overall sentiment is cautiously optimistic but with substantial risks.

Positives

• The company has made progress in the veterinary market with IsoPet, establishing regional clinics and generating initial revenue.
• Vivos has expanded its intellectual property portfolio with patents for its core technologies.
• The company has received Breakthrough Device Designation from the FDA for its proposed Indication for Use.
• Vivos has a clear path for future business growth with 18 applications for RadioGel identified by its Medical Advisory Board.
• The company has a long regulatory history with the FDA and has addressed previous concerns, positioning it for a de novo reclassification.

Negatives

• The company has a history of operating losses and an accumulated deficit of $82,450,781.
• Vivos has limited revenue and relies heavily on investor funds to maintain operations.
• The company's independent auditor has expressed substantial doubt about its ability to continue as a going concern.
• Vivos is dependent on a single supplier for Y-90 particles, which could disrupt production if supply is interrupted.
• The company has a material weakness in its internal control over financial reporting due to a lack of segregation of duties.

Risks

• The company's independent auditor has expressed substantial doubt about its ability to continue as a going concern.
• Vivos has a limited operating history and has generated material operating losses since inception.
• The company requires significant additional funding to continue the FDA approval process and conduct clinical trials.
• There is no assurance that the FDA will grant permission to market RadioGel.
• The company relies on a single supplier for Y-90 particles, and an inability to procure these particles would materially harm the business.
• The company faces competition from established players in the brachytherapy market.
• The company has a material weakness in its internal control over financial reporting.

Future Outlook

The company intends to fund its activities through strategic transactions such as licensing and partnership agreements or from proceeds to be raised from the recently qualified Regulation A+ Offering. The company plans to outsource material aspects of manufacturing, distribution, sales and marketing in the U.S. and pursue licensing arrangements and partnerships outside of the U.S.

Management Comments

• The Company believes that its submissions to the FDA to date have addressed all the FDA staffs feedback over the past four years.
• The Company anticipates that future profits, if any, will be derived from direct sales of RadioGel (under the name IsoPet) and related services, and from licensing to private medical and veterinary clinics in the U.S. and internationally.
• The Company intends to report the results from the IsoPet Solutions division as a separate operating segment in accordance with GAAP.

Industry Context

The company operates in the competitive pharmaceutical and biotechnology industries, facing challenges from companies developing similar cancer treatments. The traditional brachytherapy market is dominated by established players using I-125 and Pd-103 technologies. Vivos is attempting to differentiate itself with its Y-90 based RadioGel technology.

Comparison to Industry Standards

• The traditional brachytherapy market is dominated by companies like Oncura (a unit of General Electric Company) and C.R. Bard, which use I-125 based therapy.
• IsoRay sells Cs-131 brachytherapy products, while Vivos is focused on Y-90.
• Several Y-90 therapies have been FDA approved, including SIR-Spheres by Sirtex, TheraSphere by Biocompatibles UK, and Zevalin by Spectrum Pharmaceuticals, indicating a competitive landscape.
• Vivos is attempting to differentiate itself with its injectable particle-gel technology, which aims to deliver high radiation doses with minimal impact on surrounding tissue, contrasting with traditional metal seed implants.

Stakeholder Impact

• Shareholders face the risk of significant dilution and potential loss of investment due to the company's financial challenges.
• Employees may be affected by the company's financial instability and potential restructuring.
• Customers in the veterinary market may benefit from the availability of IsoPet therapy.
• Suppliers may be impacted by the company's financial situation and potential changes in operations.
• Creditors face the risk of non-payment due to the company's financial difficulties.

Next Steps

• The company plans to continue its efforts to obtain FDA approval for RadioGel as a Class II medical device.
• Vivos intends to conduct Phase I, pilot, and clinical trials for RadioGel.
• The company aims to activate several regional clinics to administer IsoPet across the country.
• Vivos plans to create an independent production center within the current production site.
• The company intends to initiate regulatory approval processes outside of the United States.

Key Dates

Keywords

RadioGel, IsoPet, brachytherapy, Y-90, cancer treatment, veterinary oncology, FDA approval, clinical trials, medical device, intellectual property, Regulation A+, financial results