VIVOS INC
For the period ended Jun 30, 2025. Filed Aug 13, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 13, 2025
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What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-09.
0001641172-25-009496
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-13.
0001641172-25-023437
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 57 previous paragraphs and 88 current paragraphs.
42 unchanged; 13 reworded; 25 added; 2 removed; 0 previous and 8 current paragraphs rearranged.
Tables are not compared: 5 previous and 16 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (25)
Current report
Business Overview
Current report
The Company’s IsoPet Solutions division was established in May 2016 to focus on the veterinary oncology market, namely engagement of university veterinarian hospital to develop detailed therapy procedures to treat animal tumors and ultimately use of the technology in private clinics. In January 2025 the Company restructured and aligned its internal resources and focused efforts to align with animal therapy, human therapy, and recently other applications of its patented technologies.
Current report
The Company has worked with five different national laboratories or university veterinarian hospitals on IsoPet®/RadioGel™ testing and therapy. Washington State University treated five cats for feline sarcoma and served to develop the procedures which are incorporated in our label. They concluded that the product was safe and effective in killing cancer cells. Colorado State University demonstrated the CT and PET-CT imaging of IsoPet®. The University of Missouri conducted an animal study to treat canine sarcoma. Johns Hopkins University completed a study on VX2 Tumors in Rabbits. Every study confirmed that the Y-90 stayed at the injection site with insignificant distribution outside that boundary.
Current report
Commencing in July 2019, the Company recognized its first commercial sale of IsoPet®. A veterinarian from Alaska brought his cat with a re-occurrent spindle cell sarcoma tumor on his face. The cat had previously received external beam therapy, but now the tumor was growing rapidly. He was given a high dose of 400Gy with heavy therapy at the margins.
Current report
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. Until recently the Company certified clinics at its own expense, but the demand has increased to the point that starting in 2025 the Company billed its first clinic for the certification process. We have changed to “Volume Pricing” to stimulate interest. We are targeting to increase sales in 2025 to achieve a “Breakeven” status for the Animal Therapy Division in 2026.
Current report
The plan is to incorporate the data assembled from our work with Isopet® in animal therapy to support the Company’s efforts in the development of our RadioGel™ device candidate, including obtaining approval from the FDA to market and sell RadioGel™ as a Class II medical device. RadioGel™ is an injectable particle-gel for Precision Radionuclide Therapy radiation treatment of cancerous tumors in people and animals. RadioGel™ is comprised of a hydrogel, or a substance that is liquid at room temperature and then gels when reaching body temperature after injection into a tumor. In the gel are small, less than two microns, Y-90 phosphate particles. Once injected, these inert particles are locked in place inside the tumor by the gel, delivering a very high local radiation dose. The radiation is beta, consisting of high-speed electrons. These electrons only travel a short distance so the device can deliver high radiation to the tumor with minimal dose to the surrounding tissue. Optimally, patients can go home immediately following treatment without the risk of radiation exposure to family members. Since Y-90 has a half-life of 2.7 days, the radioactivity drops to 5% of its original value after ten days.
Current report
In 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). Papillary thyroid carcinoma belongs to the general class of head and neck tumors for which tumors are accessible by intraoperative direct needle injection. The Company’s Medical Advisory Board felt that demonstrating efficacy in clinical trials with this new indication provided a more efficient pathway to regulatory clearance.
Current report
Strategic Initiatives
Current report
Over time we intend to expand the indications for use to include all lymph nodes, lung cancer, childhood brain cancer, eyelid cancer, and finally all solid tumors. Interestingly, our health physics experts agreed on all isotopes, but determining the best isotope for each therapy rapidly downsized the prime candidates.
Current report
We confirmed that our current isotope, Y-90 was effective for all the targeted indications for use. However, we also decided to explore P-32, Lu-177, and Ac-225. P-32 is not as powerful as Y-90; however, we could modify the concentration, as it has a longer half-life, which could prove to be an advantage for international shipments. While Lu-177 is relatively low-energy, we could adjust the concentration, as it has a lower penetration distance, which might be an advantage in therapies near critical structures since that would result in a higher therapeutic ratio. Ac-225 has a very low penetration distance, but it would be distributed homogeneously in our hydrogel. This could be an advantage in treating brain tumors due to its extremely low alpha penetration.
Current report
Our trademarks include BetaGel and AlphaGel and our provisional patents cover the isotopes P-32, Lu-177, and Ac-225. Over the next two years we intend to conduct laboratory testing and then animal and finally human studies in India.
Current report
The Company is exploring the viability of leveraging its technology to develop other businesses unrelated to the Company’s principal business of cancer treatment. Each business opportunity could generate income to support our primary objectives or potentially be spun off as a separate business activity to an interested party. To date the focus has been on:
Current report
In the second quarter of 2025, we signed a contract with Akina, Inc to sell and distribute our hydrogel. It is now in their catalog.
Current report
Intellectual Property
Current report
Our original license agreement with Battelle National Laboratory (the “Battelle License”) reached its end of life in 2022. We have expanded our proprietary knowledge, as well as our trademark and patent protection, during the past several years in anticipation of the Battelle License reaching the end of its term
Current report
Our trademark protection, which is extended to 17 countries, has been expanding continuously:
Current report
We own applications/registrations for the following as noted below:
Current report
We have systematically filed provisional and utility patents that cover our key components, hydrogel and the yttrium phosphate particles, and our injection system in the US patent office and in more than ten other offices covering approximately 63 counties.
Current report
In January 2025 we filed an additional provisional patent on the control, transport, and delivery of PrecisionGel.
Current report
Comparison of the Six months Ended June 30, 2025 and 2024
Current report
Revenue was $41,748 and $18,000 for the six months ended June 30, 2025 and 2024, respectively. All revenue recognized in the six months ended June 30, 2025 and 2024 relate to the procedures performed with respect to the IsoPet® therapies, sales of IsoPet®and freight. In 2025, we recognized revenue for the licensing and certification of clinics approximating $20,000.
Current report
Our net loss for the six months ended June 30, 2025 and 2024 was $(1,480,209) and $(1,061,997), respectively.
Current report
Operating Expenses
Current report
Non-Operating Income
Removed paragraphs (2)
Previous report
Vivos Inc. (the “Company”) was incorporated under the laws of Delaware on December 23, 1994 as Savage Mountain Sports Corporation (“SMSC”). On September 6, 2006, the Company changed its name to Advanced Medical Isotope Corporation, and on December 28, 2017, the Company began operating as Vivos Inc. The Company has authorized capital of 950,000,000 shares of common stock, $0.001 par value per share (“Common Stock”), and 20,000,000 shares of preferred stock, $0.001 par value per share (“Preferred Stock”).
Previous report
Our principal place of business is located at 1030 North Center Parkway, Kennewick, WA 99336. Our telephone number is (509) 222-2222. Our corporate website address is http://www.radiogel.com. Our Common Stock is currently quoted on the OTC Pink Marketplace under the symbol “RDGL.”
Reworded paragraphs (13)
Previous wording
The Company is a radiation oncology medical device company engaged in the development of its yttrium-90 (“Y-90”) based precision radionuclide therapy device, RadioGel™, for the treatment of non-resectable tumors, now trademarked as Precision Radionuclide Therapy TM. A prominent team of radiochemists, scientists, and engineers, collaborating with strategic partners, including national laboratories, universities, and private corporations, lead the Company’s development efforts. The Company’s overall vision is to globally empower physicians, medical researchers, and patients by providing them with new isotope technologies that offer safe and effective treatments for cancer.
Current wording
Vivos Inc. (the “Company,” “we,” “us,” “our”) is a radiation oncology medical device company engaged in the development of its yttrium-90 (“Y-90”) based precision radionuclide therapy device, RadioGel™, for the treatment of non-resectable tumors, now trademarked as Precision Radionuclide Therapy™. A prominent team of radiochemists, scientists, and engineers, collaborating with strategic partners, including national laboratories, universities, and private corporations, lead the Company’s development efforts. The Company’s overall vision is to globally empower physicians, medical researchers, and patients by providing them with new isotope technologies that offer safe and effective treatments for cancer.
Previous wording
In January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel TMshould be classified as a device for animal therapy of feline sarcomas and canine soft tissue sarcomas. Additionally, after a legal review, the Company believes that the device classification obtained from the FDA Center for Veterinary Medicine is not limited to canine and feline sarcomas, but rather may be extended to a much broader population of veterinary cancers, including all or most solid tumors in animals. We expect the result of such classification and label review will be that no additional regulatory approvals are necessary for the use of IsoPet®for the treatment of solid tumors in animals. The FDA does not have premarket authority over devices with a veterinary classification, and the manufacturers are responsible for assuring that the product is safe, effective, properly labeled, and otherwise in compliance with all applicable laws and regulations.
Current wording
In January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel™ should be classified as a device for animal therapy of feline sarcomas and canine soft tissue sarcomas. Additionally, after a legal review, the Company believes that the device classification obtained from the FDA Center for Veterinary Medicine is not limited to canine and feline sarcomas but rather may be extended to a much broader population of veterinary cancers, including all or most solid tumors in animals. We expect the result of such classification and label review will be that no additional regulatory approvals are necessary for the use of IsoPet®for the treatment of solid tumors in animals. The FDA does not have premarket authority over devices with a veterinary classification, and the manufacturers are responsible for assuring that the product is safe, effective, properly labeled, and otherwise in compliance with all applicable laws and regulations.
Previous wording
Based on the FDA’s recommendation, RadioGel TM is being marketed as “IsoPet®” for use by veterinarians to avoid any confusion between animal and human therapy. The Company already has trademark protection for the “IsoPet®” name. IsoPet®and RadioGel TM are used synonymously throughout this document. The only distinction between IsoPet®and RadioGel TM is the FDA’s recommendation that we use “IsoPet®” for veterinarian usage, and reserve “RadioGel TM”for human therapy. Historically, the Company’s primary focus was on the development and marketing of Isopet® for animal therapy, through the Company’s IsoPet® Solutions division. Over the last four years much effort has been directed to completing the testing require to obtain FDA approval for an Investigational Device Exemption and to obtain approval for clinical trials in India.
Current wording
Based on the FDA’s recommendation, RadioGel™ is being marketed as “IsoPet®” for use by veterinarians to avoid any confusion between animal and human therapy. The Company already has trademark protection for the “IsoPet®” name. IsoPet®and RadioGel™ are used synonymously throughout this document. The only distinction between IsoPet®and RadioGel™ is the FDA’s recommendation that we use “IsoPet®” for veterinarian usage, and reserve “RadioGel™” for human therapy. Historically, the Company’s primary focus was on the development and marketing of Isopet® for animal therapy, through the Company’s IsoPet® Solutions division. Over the last four years much effort has been directed to completing the testing require to obtain FDA approval for an Investigational Device Exemption and to obtain approval for clinical trials in India.
Previous wording
During the year ended December 31, 2023, $1,179,245 was raised through the sale of 16,132,000 shares of Common Stock through the Regulation A+ Offerings and concurrent private placements of 18,797,000 warrants. During the year ended December 31, 2024, $2,266,000 was raised through the issuance of 24,950,000 shares of Common Stock through the Regulation A+ Offerings. During the three months ended March 31, 2025, $1,500,000 was raised through the issuance of 12,500,000 shares of Common Stock through the Regulation A+ Offerings and $6,250 through a concurrent private placement of 6,250,000 warrants.
Current wording
During the year ended December 31, 2023, $1,179,245 was raised through the sale of 16,132,000 shares of Common Stock through the Regulation A+ Offerings and concurrent private placements of 18,797,000 warrants. During the year ended December 31, 2024, $2,266,000 was raised through the issuance of 24,950,000 shares of Common Stock through the Regulation A+ Offerings. During the six months ended June 30, 2025, $1,500,000 was raised through the issuance of 12,500,000 shares of Common Stock through the Regulation A+ Offerings and $6,250 through a concurrent private placement of 6,250,000 warrants.
Previous wording
As of March 31, 2025, the Company had $3,265,100 in cash on hand. There are currently commitments to vendors for products and services purchased. To continue the development of the Company’s products, the current level of cash will be insufficient to cover the fixed and variable obligations of the Company.
Current wording
As of June 30, 2025, the Company had $2,660,590 in cash on hand. There are currently commitments to vendors for products and services purchased. To continue the development of the Company’s products, the current level of cash will be insufficient to cover the fixed and variable obligations of the Company.
Previous wording
The continued deployment of the precision radionuclide therapy products and a worldwide regulatory approval effort will require additional resources and personnel. The principal variables in the timing and amount of spending for the precision radionuclide therapy products in the next 12 to 24 months will be the FDA’s classification of the Company’s precision radionuclide therapy products as Class II or Class III devices (or otherwise) and any requirements for additional studies which may possibly include clinical studies. Thereafter, the principal variables in the amount of the Company’s spending and its financing requirements would be the timing of any approvals and the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing of those products and the products’ success in the U.S. and elsewhere. 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.
Current wording
The continued deployment of precision radionuclide therapy products and a worldwide regulatory approval effort will require additional resources and personnel. The principal variables in the timing and amount of spending for the precision radionuclide therapy products in the next 12 to 24 months will be the FDA’s classification of the Company’s precision radionuclide therapy products as Class II or Class III devices (or otherwise) and any requirements for additional studies which may possibly include clinical studies. Thereafter, the principal variables in the amount of the Company’s spending and its financing requirements would be the timing of any approvals and the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing of those products and the products’ success in the U.S. and elsewhere. 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.
Previous wording
Revenue was $26,748 and $4,500 for the three months ended March 31, 2025 and 2024, respectively. All revenue recognized in the three months ended March 31, 2025 and 2024 except for $19,988 in the three months ended March 31, 2025 relate to the procedures performed with respect to the IsoPet® therapies.
Current wording
Revenue was $15,000 and $13,500 for the three months ended June 30, 2025 and 2024, respectively. All revenue recognized in the three months ended June 30, 2025 and 2024 relate to the procedures performed with respect to the IsoPet® therapies, sales of IsoPet®and freight.
Previous wording
Operating expense for the three months ended March 31, 2025 and 2024 was $854,449 and $575,629, respectively. The increase in operating expense from 2024 to 2025 can be attributed to the increase in professional fees ($403,637 for the three months ended March 31, 2024 versus $588,268 for the three months ended March 31, 2025) related to the fees incurred for the consultants engaged in 2025 versus 2024; the increase in general and administrative expense ($23,420 for the three months ended March 31, 2024 versus $52,203 for the three months ended March 31, 2025); the increase in research and development ($57,447 for the three months ended March 31, 2024 versus $119,281 for the three months ended March 31, 2025) as the Company continued to ramp up the development of their products in 2025 in India as well as the US including research studies as well as continuing the steps necessary to be accepted by the FDA, and an increase in payroll expense ($91,125 for the three months ended March 31, 2024 versus $94,697 for the three months ended March 31, 2025) related to the CEOs employment contract and bonus.
Current wording
Operating expense for the three months ended June 30, 2025 and 2024 was $640,019 and $525,029, respectively. The increase in operating expense from 2024 to 2025 can be attributed to the increase in professional fees ($279,814 for the three months ended June 30, 2024 versus $358,454 for the three months ended June 30, 2025) related to the fees incurred for the consultants engaged in 2025 versus 2024 and the value of the vested RSUs; the increase in general and administrative expense ($54,925 for the three months ended June 30, 2024 versus $80,913 for the three months ended June 30, 2025); the increase in research and development ($99,662 for the three months ended June 30, 2024 versus $107,965 for the three months ended June 30, 2025) as the Company continued to ramp up the development of their products in 2025 in India as well as the US including research studies as well as continuing the steps necessary to be accepted by the FDA, and an increase in payroll expense ($90,628 for the three months ended June 30, 2024 versus $92,687 for the three months ended June 30, 2025) related to the CEOs employment contract and bonus.
Previous wording
Our net loss for the three months ended March 31, 2025 and 2024 was $(834,696) and $(558,539), respectively.
Current wording
Our net loss for the three months ended June 30, 2025 and 2024 was $(645,513) and $(503,458), respectively.
Previous wording
At March 31, 2025, the Company had working capital of $3,186,489, as compared to working capital of $2,147,247 at December 31, 2024. As of March 31, 2025, the Company did not have any commitments for capital expenditures.
Current wording
At June 30, 2025, the Company had working capital of $2,679,098, as compared to working capital of $2,147,247 at December 31, 2024. As of June 30, 2025, the Company did not have any commitments for capital expenditures.
Previous wording
Net cash used in operating activities for the three months ended March 31, 2025 and 2024, was $455,198 and $351,458, respectively. Cash used in operating activities was primarily related to the Company’s net loss from operations, stock-based compensation, as well as the changes in accounts receivable, inventory, prepaid expense, and accounts payable. During the three months ended March 31, 2025 and 2024, there was no cash used in investing activities. Net cash provided by financing activities for the three months ended March 31, 2025 and 2024 was $1,507,750 and $130,000, respectively, consisting of proceeds from the sales of Common Stock and warrants as part of our Regulation A+ Offerings.
Current wording
Net cash used in operating activities for the six months ended June 30, 2025 and 2024, was $1,059,708 and $706,870, respectively. Cash used in operating activities was primarily related to the Company’s net loss from operations, stock-based compensation, as well as the changes in accounts receivable, inventory, prepaid expense, and accounts payable. During the six months ended June 30, 2025 and 2024, there was no cash used in investing activities. Net cash provided by financing activities for the six months ended June 30, 2025 and 2024 was $1,507,750 and $839,000, respectively, consisting of proceeds from the sales of Common Stock and warrants as part of our Regulation A+ Offerings.
Previous wording
The Company has generated material operating losses since inception. The Company had a net loss of $834,696 for the three months ended March 31, 2025 as compared to a net loss of $558,539 for the three months ended March 31, 2024. The Company expects to continue to experience net operating losses for the foreseeable future. Historically, the Company has relied upon investor funds to maintain its operations and develop the Company’s business. The Company anticipates raising additional capital within the next twelve months for working capital as well as business expansion, although the Company can provide no assurance that additional capital will be available on terms acceptable to the Company, if at all. If the Company is unable to obtain additional financing to meet its working capital requirements, it may have to curtail its business or cease all operations.
Current wording
The Company has generated material operating losses since inception. The Company had a net loss of $1,480,209 for the six months ended June 30, 2025 as compared to a net loss of $1,061,997 for the six months ended June 30, 2024. The Company expects to continue to experience net operating losses for the foreseeable future. Historically, the Company has relied upon investor funds to maintain its operations and develop the Company’s business. The Company anticipates raising additional capital within the next twelve months for working capital as well as business expansion, although the Company can provide no assurance that additional capital will be available on terms acceptable to the Company, if at all. If the Company is unable to obtain additional financing to meet its working capital requirements, it may have to curtail its business or cease all operations.
Previous wording
The Company requires funding of at least $3.0 million per year to maintain current operating activities. Over the next 36 months, the Company believes it will require approximately $9,0 million in additional capital to: (i) fund the FDA approval process to conduct human clinical trials; (ii) conduct Phase I, pilot, and clinical trials; (iii) activate several regional clinics to administer IsoPet®across the county; (iv) create an independent production center within the current production site to create a template for future international manufacturing; and (v) initiate regulatory approval processes outside of the United States.
Current wording
The Company requires funding of at least $3.0 million per year to maintain current operating activities. Over the next 36 months, the Company believes it will require approximately $9.0 million in additional capital to: (i) fund the FDA approval process to conduct human clinical trials; (ii) conduct Phase I, pilot, and clinical trials; (iii) activate several regional clinics to administer IsoPet®across the county; (iv) create an independent production center within the current production site to create a template for future international manufacturing; and (v) initiate regulatory approval processes outside of the United States.
Rearranged current paragraphs (8)
Current report — wording carried from elsewhere
The following table sets forth information from our statements of operations for the six months ended June 30, 2025 and 2024:
Current report — wording carried from elsewhere
Operating expense for the six months ended June 30, 2025 and 2024, respectively consists of the following:
Current report — wording carried from elsewhere
Operating expense for the six months ended June 30, 2025 and 2024 was $1,494,470 and $1,100,659, respectively. The increase in operating expense from 2024 to 2025 can be attributed to the increase in professional fees ($683,452 for the six months ended June 30, 2024 versus $946,723 for the six months ended June 30, 2025) related to the fees incurred for the consultants engaged in 2025 versus 2024 and increase in value of RSUs vested; the increase in general and administrative expense ($78,345 for the six months ended June 30, 2024 versus $133,117 for the six months ended June 30, 2025); the increase in research and development ($157,109 for the six months ended June 30, 2024 versus $227,246 for the six months ended June 30, 2025) as the Company continued to ramp up the development of their products in 2025 in India as well as the US including research studies as well as continuing the steps necessary to be accepted by the FDA, and an increase in payroll expense ($181,753 for the six months ended June 30, 2024 versus $187,384 for the six months ended June 30, 2025) related to the CEOs employment contract and bonus.
Current report — wording carried from elsewhere
Non-operating income for the six months ended June 30, 2025 and 2024 were as follows:
Current report — wording carried from elsewhere
Non-operating income for the six months ended June 30, 2025 and 2024 related to interest earned on the Company’s cash accounts.
Current report — wording carried from elsewhere
Revenues and Cost of Goods Sold
Current report — wording carried from elsewhere
Management does not anticipate that the Company will generate sufficient revenue to sustain operations until such time as the Company secures multiple revenue-generating arrangements with respect to RadioGel™ and/or any of our other brachytherapy technologies.
Current report — wording carried from elsewhere
Commencing in 2025, the Company had started ordering Hydrogel to use in more than one treatment. This is anticipated to increase the number of treatments that can be handled in a particular clinic monthly. As a result, we have inventory built up that when used will increase our cost of goods sold over time.