8-K: Vivos Inc. Announces Encouraging Initial Results from RadioGel Human Clinical Trials, Plans Expansion

Vivos Inc. reports positive initial safety results and early signs of efficacy from its RadioGel Precision Radionuclide Therapy human clinical trials, leading to plans for trial expansion.

Summary

• Vivos Inc. announced encouraging initial results from its human clinical trials of RadioGel Precision Radionuclide Therapy.
• The first five patients demonstrated the safety of RadioGel by meeting the criteria in the Clinical Study Plan, with no adverse events reported.
• PET imaging confirmed that the Y-90 remained at the point of injection.
• 30-day PET/F-18 imaging of a patient with a cancerous node near the trachea revealed an over 80% reduction in both tumor size and metastatic activity.
• The lead investigator intends to request authority to increase the study from 30 patients to 50 patients.
• The expanded trial will include the utilization of new deep injection technology being installed and tested in the treatment hospital in India.
• The company anticipates completing the initial 30-patient trial by June 30 and the expanded trial by year-end.
• The trials comprehensive data will be submitted for publication in leading medical journals and shared with the FDA.
• Vivos continues to collaborate with IsoTherapeutics, recently acquired by Telix, to enhance production capacity for both Isopet and RadioGel.
• The company is evaluating additional manufacturing partners in India and other regions to support global supply chain expansion.

Sentiment

Score: 8

Explanation: The document presents a positive outlook due to encouraging initial clinical trial results and plans for expansion. The management's optimistic comments and focus on growth initiatives further contribute to the positive sentiment.

Positives

• RadioGel demonstrated safety in the initial five patients of the clinical trial.
• One patient showed an over 80% reduction in tumor size and metastatic activity.
• The company is expanding the clinical trial to gather more data on a variety of cancers.
• New deep injection technology will allow for the treatment of deeper-seated tumors.
• Collaboration with IsoTherapeutics/Telix aims to enhance production capacity.
• The company is actively seeking additional manufacturing partners for global expansion.

Risks

• Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated.
• These risks include the company's ability to successfully execute its expanded business strategy, general economic and business conditions, competition, changes in technology, delays in completing programs, regulatory requirements, and various other factors beyond the company's control.

Future Outlook

Vivos anticipates completing the initial 30-patient trial by June 30 and the expanded trial by year-end, with plans to submit data for publication and share results with the FDA to support RadioGel's safety profile and expanded indications for use in the United States. The company is also advancing key growth initiatives to strengthen RadioGel's competitive position.

Management Comments

• After years of dedicated effort, we are thrilled with these initial clinical trial results and optimistic about future findings, stated CEO Mike Korenko.
• As the study progresses, we look forward to sharing additional updates, stated CEO Mike Korenko.
• We are advancing key growth initiatives to strengthen RadioGel's competitive position, and we will provide further updates on these technology and business developments in the coming weeks and months, stated CEO Mike Korenko.

Industry Context

The announcement highlights Vivos Inc.'s progress in the field of Precision Radionuclide Therapy, a growing area in cancer treatment. The use of Yttrium-90 and hydrogel technology positions RadioGel as a potentially innovative approach compared to traditional external-beam radiation therapy. Telix's acquisition of IsoTherapeutics suggests increasing interest and investment in radiopharmaceutical manufacturing.

Comparison to Industry Standards

• RadioGel's short half-life, delivering over 90% of its therapeutic radiation within 10 days, compares favorably to other available treatment options requiring up to six weeks or more.
• Companies like Telix Pharmaceuticals and ITM Isotope Technologies Munich SE are also active in the radiopharmaceutical space, focusing on targeted cancer therapies.
• The 80% reduction in tumor size observed in one patient is a promising early indicator, although further data from the expanded trial is needed to assess efficacy across a broader patient population.

Stakeholder Impact

• Shareholders: Positive clinical trial results could increase investor confidence.
• Patients: RadioGel offers a potentially safer and more effective treatment option.
• Employees: Expansion plans may lead to job creation.
• Suppliers: Increased production capacity could lead to higher demand for raw materials.
• Creditors: Positive results could improve the company's financial stability.

Next Steps

• Presenting the data from the initial patients to the Ethics Committee.
• Requesting authority to increase the study from 30 patients to 50 patients.
• Completing the initial 30-patient trial by June 30.
• Completing the expanded trial by year-end.
• Submitting the trials comprehensive data for publication in leading medical journals.
• Sharing results with the FDA to further support RadioGel's safety profile and reinforce the Investigational Device Exemption (IDE) submission.
• Advancing key growth initiatives to strengthen RadioGel's competitive position.
• Providing further updates on technology and business developments in the coming weeks and months.

Key Dates