10-Q: Vivos Inc. Reports First Quarter 2025 Results, Revenue Increases but Losses Persist

Sentiment:

Quarterly Report 9 May 2025 5:14 PM

Vivos Inc. reports increased revenue for Q1 2025, driven by IsoPet therapies and clinic certifications, but continues to face significant net losses and going concern uncertainties.

Capital raiseThe company raised $1,500,000 through the issuance of 12,500,000 shares of common stock and $6,250 through a private placement of warrants during Q1 2025.The company requires additional funding of approximately $3.0 million annually to maintain operating activities.Over the next 36 months, the Company believes it will require approximately $9.0 million in additional capital to fund clinical trials, expand IsoPet administration, and establish an independent production center.

Worse than expectedThe company's net loss increased compared to the same period last year.Operating expenses increased significantly.The company's auditor has expressed substantial doubt about its ability to continue as a going concern.

Summary

Vivos Inc. reported a net loss of $834,696 for the three months ended March 31, 2025, compared to a net loss of $558,539 for the same period in 2024.
Revenue increased to $26,748 for Q1 2025 from $4,500 in Q1 2024, primarily due to IsoPet therapies and clinic certifications.
Operating expenses rose to $854,449 in Q1 2025 from $575,629 in Q1 2024, driven by higher professional fees, research and development costs, and general and administrative expenses.
The company raised $1,500,000 through the issuance of 12,500,000 shares of common stock and $6,250 through a private placement of warrants during Q1 2025.
Vivos Inc. is focused on developing RadioGel for human and animal cancer treatment and is pursuing clinical trials in India.
The company's independent auditor has expressed substantial doubt about its ability to continue as a going concern.
Vivos Inc. estimates needing $9 million in additional capital over the next 36 months to fund clinical trials, expand IsoPet administration, and establish an independent production center.

Sentiment

Score: 4

Explanation: The sentiment is cautiously negative. While there's revenue growth and progress in clinical trials, the increasing losses, reliance on capital raises, and going concern warning overshadow the positives.

Positives

Revenue increased significantly due to IsoPet therapies and clinic certifications.
The company is actively pursuing human clinical trials in India.
Vivos Inc. received Breakthrough Device designation from the FDA for RadioGel Precision Radionuclide Therapy, granting access to a rapid review process.
The company is exploring new business opportunities leveraging its hydrogel technology, trademarked as Precision GelTM.
The company raised $1,500,000 through the issuance of 12,500,000 shares of common stock and $6,250 through a private placement of warrants during Q1 2025.

Negatives

The company reported a net loss of $834,696 for Q1 2025, an increase from the $558,539 loss in Q1 2024.
Operating expenses increased significantly, driven by higher professional fees and R&D costs.
The company's independent auditor has expressed substantial doubt about its ability to continue as a going concern.
The company has limited revenue, nominal cash, and has accumulated deficits since inception.

Risks

The company's ability to continue as a going concern is uncertain and dependent on securing additional funding.
The company faces risks associated with regulatory approvals for RadioGel and other brachytherapy products.
The company's success depends on its ability to successfully commercialize its brachytherapy products.
The company's financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
The company requires additional funding of approximately $3.0 million annually to maintain operating activities.

Future Outlook

The company intends to outsource material aspects of manufacturing, distribution, sales, and marketing for operations within the U.S. and pursue licensing arrangements and/or partnerships outside of the U.S. to facilitate its global commercialization strategy. Long-term, the Company intends to consider resuming research efforts with respect to other products and technologies intended to help improve the diagnosis and treatment of cancer and other illnesses.

Industry Context

Vivos Inc. operates in the radiation oncology medical device industry, focusing on precision radionuclide therapy. The company's efforts to obtain FDA approval for RadioGel and pursue clinical trials align with industry trends in developing targeted cancer treatments. The Breakthrough Device designation from the FDA is a significant milestone, potentially accelerating the regulatory pathway for RadioGel.

Comparison to Industry Standards

It is difficult to compare Vivos Inc. directly to industry standards due to its early stage of development and unique product focus.
Larger, established medical device companies like Varian Medical Systems (now Siemens Healthineers) and Elekta offer a range of radiation therapy solutions, but Vivos Inc. is focused on a specific niche with its RadioGel technology.
The company's success will depend on its ability to demonstrate the safety and efficacy of RadioGel in clinical trials and secure regulatory approvals, as well as its ability to commercialize the product effectively.
The company's focus on animal therapy through IsoPet provides an early revenue stream and valuable data that can support its human therapy development efforts.

Related Party Transactions

In December 2024, our Chief Executive Officer advanced $ 40,949 to the Company, which amount was repaid within ten days.
Cadwell Laboratories, which is controlled by Carl Cadwell, a director of the Company, provides office space to management on an as-needed basis until such time as the Company leases permanent office space.

Stakeholder Impact

Shareholders face the risk of dilution due to ongoing equity offerings.
Employees' job security is tied to the company's ability to secure funding and achieve profitability.
Customers (veterinarians and pet owners) could benefit from the availability of IsoPet therapy, but its long-term viability depends on the company's success.
Suppliers and creditors face the risk of non-payment if the company fails to secure additional funding.

Next Steps

The company intends to expand the indications for use in phases: first, for lymph nodes associated with thyroid cancer, secondly, cancerous lung nodules, and finally, all non-sectable solid tumors.
The company intends to fund its activities through strategic transactions such as licensing and partnership agreements or from proceeds raised from the Regulation A+ Offerings.
The company intends to expand the indications for use in phases: first, for lymph nodes associated with thyroid cancer, secondly, cancerous lung nodules, and finally, all non-sectable solid tumors.

Key Dates

Date	Description
1994-12-23	Vivos Inc. was incorporated as Savage Mountain Sports Corporation.
2006-09-06	The company changed its name to Advanced Medical Isotope Corporation.
2013	The FDA determined that RadioGel is a device for human therapy for non-resectable cancers.
2015-06-30	A certificate of designations was filed with the Delaware Secretary of State to designate 2,500,000 shares of the Company's Preferred Stock as Series A Convertible Preferred Stock.
2016-03-31	The Company amended the Series A COD, increasing the maximum number of shares of Series A Preferred from 2,500,000 shares to 5,000,000 shares.
2016-05	The Companys IsoPet Solutions division was established to focus on the veterinary oncology market.
2017-12-28	The Company began operating as Vivos Inc.
2018-01	The Center for Veterinary Medicine Product Classification Group ruled that RadioGelTM should be classified as a device for animal therapy of feline sarcomas and canine soft tissue sarcomas.
2018-10-10	A certificate of designation was filed with the Delaware Secretary of State to designate 5,000,000 shares of our Preferred Stock as Series B Convertible Preferred Stock.
2019-03-27	A certificate of designation was filed with the Delaware Secretary of State to designate 5,000,000 shares of our Preferred Stock as Series C Convertible Preferred Stock.
2019-06-04	The Company entered into an Executive Employment Agreement with Dr. Michael K. Korenko.
2019-07	The Company recognized its first commercial sale of IsoPet.
2019-11	The SEC qualified the Companys offering of its Common Stock, under Regulation A of Section 3(6) of the Securities Act of 1933, as amended (the Securities Act) (Regulation A), which offering was amended from time to time thereafter (the 2019 Regulation A+ Offering).
2020-12-31	The Company extended the Employment Agreement through December 31, 2021 while renegotiating terms of a new Employment Agreement.
2021	The Company modified its Indication for Use from skin cancer to cancerous tissue or solid tumors pathologically associated with locoregional papillary thyroid carcinoma and recurrent papillary thyroid carcinoma having discernable tumors associated with metastatic lymph nodes or extranodal disease in patients who are not surgical candidates or who have declined surgery, or patients who require post-surgical remnant ablation (for example, after prior incomplete radioiodine therapy).
2021-05-03	The Company and the Chief Executive Officer agreed the terms of a new Employment Agreement with an effective date of January 1, 2021 that has a term of three years and expired December 31, 2023.
2021-09	The SEC qualified the Companys offering of Common Stock under Regulation A, which offering was amended from time to time thereafter (the 2021 Regulation A Offering).
2022	Our original license agreement with Battelle National Laboratory (the Battelle License) reached its end of life.
2023-12	The FDA granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device pursuant to the FDAs Breakthrough Devices Program.
2023-12-31	The Company renewed the Employment Agreement for a term of two years expiring December 31, 2025.
2024-01-01	The Company granted Dr. Korenko 20,000,000 restricted stock units on January 1, 2024 that vest over the 2 two-year period.
2024-07-17	The SEC qualified the Companys offering under Regulation A to offer up to $ 60,000,000 shares of its Common Stock (the July 2024 Regulation A+ Offering.
2024-12	Our Chief Executive Officer advanced $ 40,949 to the Company, which amount was repaid within ten days.
2024-12-16	There was 200,000 Series B Preferred shares converted into 2,500,000 common shares.
2025-01	The Company restructured and aligned its internal resources and focused effort to align with animal therapy, human therapy, and recently other applications of its patented technologies.
2025-01	The Company began actively pursuing human clinical trials in India.
2025-01	The Company filed a new provisional patent in January 2025 to cover retention, transport, and release of a broad range of agents.
2025-01	The Company received $ 1,500 from warrants exercised in December 2024.
2025-02	The Company issued 12,500,000 shares of Common Stock in their Regulation A+ Offering, and 6,250,000 warrants in the amount of $ 1,506,250.
2025-03	The Company issued 38,422 shares of Common Stock for services rendered valued at $ 4,688.
2025-04	The Company issued 100,000 shares of Common Stock to a consultant for services rendered.
2025-05-09	Date of report.

Keywords

RadioGel, IsoPet, Radionuclide Therapy, Clinical Trials, FDA Approval, Yttrium-90, Cancer Treatment, Vivos Inc., Financial Results

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