Upper Deck Research: Vivos Inc. (RDGL) is a Neutral-Plus Opportunity
Date: January 26, 2024
Analyst: Joshua Enomoto
Editing note: The correct company name is Vivos Inc. Apologies for the error.
Rather than applying blunt-force attacks against cancer, Vivos Inc. instead wields a scalpel of hope – Biopolymer Enabled Microbrachytherapy (BEMT) to be exact. This innovative platform delivers targeted radiation therapy like a precision strike, minimizing collateral damage to healthy tissue. Think of it as tiny, radioactive microgels – like stealthy surgeons – infiltrating tumors and delivering their therapeutic payload directly to the enemy, leaving surrounding areas unharmed.
While still in its early stages, Vivos boasts a seasoned team of biotech veterans navigating the intricate map of clinical trials and regulatory landscapes. Their ultimate goal? To claim a significant share of the immense $300 billion+ cancer treatment market. With every successful trial, every tumor vanquished, they inch closer to rewriting the narrative for countless patients battling this formidable foe. Vivos is a young company with a bold vision, wielding a potentially game-changing tool in the fight against cancer.
Executive Summary
Vivos Inc. (OTCMKTS:RDGL) is a pre-revenue clinical-stage biotechnology company developing an innovative platform technology called Biopolymer Enabled Microbrachytherapy (BEMT) for the treatment of solid tumors. Their lead candidate, 90Y-RadioGel, is a radioactive microgel injected directly into tumors to deliver targeted radiation therapy with minimal side effects. This report analyzes Vivos’ potential, risks, and investment thesis based on their BEMT technology and recent developments.
Investment Highlights
- Promising Technology: BEMT offers a potentially safer and more effective alternative to traditional cancer treatments like surgery and radiation therapy. 90Y-RadioGel delivers targeted radiation directly to the tumor, minimizing exposure to healthy tissues and reducing side effects.
- Early Clinical Progress: Vivos has successfully completed a Phase I/IIa study of 90Y-RadioGel in dogs with soft-tissue sarcomas, demonstrating safety and efficacy. Phase I/II trials in humans with metastatic soft-tissue sarcomas and recurrent head and neck squamous cell carcinoma are ongoing.
- Experienced Management Team: Vivos’ leadership team consists of seasoned biotech executives with extensive experience in drug development and commercialization.
- Large Addressable Market: The global cancer treatment market is projected to reach $300 billion by 2025, with solid tumors representing a significant portion. If successful, BEMT could capture a substantial share of this market.
Vivos White Paper
Vivos conducted an early study to investigate the feasibility and safety of using 90Y-RadioGel, a novel injectable radioactive compound, for treating soft-tissue sarcomas in cats and dogs. The results show promising potential for this therapy, with high intratumoral radiation doses, minimal side effects, and complete responses in some cases. Further research is needed to optimize dosages and confirm efficacy in humans.
Methodology: Five cats and three dogs with sarcomas received intratumoral injections of 90Y-RadioGel. Tumor response was monitored with imaging (PET/CT, ultrasound) and histopathology. Dose-volume histograms and therapeutic ratios were calculated.
Results:
- 90Y-RadioGel remained confined to the tumor, with minimal migration to other organs.
- PET/CT confirmed homogenous radiation dose distribution within the tumor.
- No adverse radiation-related effects were observed in treated animals.
- Mild skin reactions occurred in some cases but resolved without intervention.
- Complete remission or stable disease was achieved in some animals, particularly with higher doses.
- Histopathology showed extensive tumor cell death in treated areas.
Discussion:
- 90Y-RadioGel offers a potentially safe and effective alternative to surgery or radiation therapy for sarcomas.
- Its intratumoral delivery minimizes exposure to healthy tissues, leading to fewer side effects.
- High local radiation doses can effectively destroy tumor cells.
- The study provides valuable data for future clinical trials in human patients.
Potential Opportunities:
- 90Y-RadioGel could become a significant market opportunity if clinical trials in humans confirm its efficacy and safety.
- The potential for minimal side effects and improved patient outcomes is a major advantage over existing treatment options.
- Vivos, as the developer of 90Y-RadioGel, is well-positioned to capitalize on this potential with further research and development.
Factors to Consider:
- The long-term efficacy and safety of 90Y-RadioGel in humans needs to be established through further clinical trials.
- Regulatory approval will be required before widespread adoption.
- Competition from existing treatment options exists, although 90Y-RadioGel offers potential advantages.
Conclusion: This study demonstrates the promising potential of 90Y-RadioGel for treating sarcomas in animals. Further research in humans is warranted to confirm its efficacy and safety, potentially leading to a significant new treatment option for cancer patients.
Key Risks
- Clinical Stage: Vivos is still in the early stages of clinical development, and their success depends on the outcomes of ongoing and future clinical trials. Failure to achieve positive results could significantly impact their value proposition.
- Regulatory Pathway: Obtaining regulatory approval for BEMT will be a lengthy and challenging process. Delays or setbacks could hinder Vivos’ progress and commercialization timeline.
- Competition: Vivos faces competition from established players in the oncology space, including pharmaceutical companies and other radiation therapy technologies. Differentiating BEMT and demonstrating its advantages will be crucial for success.
- Administrative: Prospective investors should understand that RDGL stock is traded over the counter, which among other risks are wide bid-ask spreads and thin trading volume.
Investment Thesis
Vivos represents a high-risk, high-reward investment opportunity. Their BEMT technology has the potential to disrupt the cancer treatment landscape, but significant challenges remain. Investors should carefully consider their risk tolerance and investment horizon before making a decision.
Valuation
Given Vivos’ pre-revenue stage and the uncertainties surrounding their clinical development, traditional valuation metrics like P/E ratio are not applicable. However, considering the potential of BEMT and the size of the addressable market, Vivos could be a valuable investment for long-term, risk-tolerant investors.
Conclusion
Vivos is an exciting company with a potentially game-changing technology. While uncertainties remain, their progress in clinical development and experienced management team offer promising prospects. Investors seeking exposure to the oncology space with a high-growth potential should keep a close eye on Vivos’ progress.
Disclaimer: The author may consider a small, speculative position in RDGL over the next 72 hours. This report is for informational purposes only and should not be considered financial advice. Please consult with a qualified financial advisor before making any investment decisions. Most of this article was generated through artificial intelligence. While reasonable care was taken regarding accuracy, it’s vital that the reader conduct due diligence.
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