Quarterly Report for Quarter Ending June 30, 2025 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations.

Except for statements of historical fact, certain information described in this Quarterly Report on Form 10-Q ("Quarterly Report") contains "forward-looking statements" that involve substantial risks and uncertainties. You can identify these statements by forward-looking words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "should," "will," "would" or similar words. The statements that contain these or similar words should be read carefully because these statements discuss the Company's future expectations, including its expectations of its future results of operations or financial position, or state other "forward-looking" information. Vivos Inc. believes that it is important to communicate its future expectations to its investors. However, there may be events in the future that the Company is not able to accurately predict or to control. Further, the Company urges you to be cautious of the forward-looking statements which are contained in this Quarterly Report because they involve risks, uncertainties and other factors affecting its operations, market growth, service, products and licenses. The risk factors in the section captioned "Risk Factors" in Item 1A of the Company's Annual Report on Form 10-K, filed with the SEC on March 24, 2025, as well as other cautionary language in this Quarterly Report, describe such risks, uncertainties and events that may cause the Company's actual results and achievements, whether expressed or implied, to differ materially from the expectations the Company describes in its forward-looking statements. The occurrence of any of the events described as risk factors could have a material adverse effect on the Company's business, results of operations and financial position.

Business Overview

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.

In 2013, the United States Food and Drug Administration ("FDA") issued the determination that RadioGel™ is a device for human therapy for non-resectable cancers in humans. This should result in a faster path than a drug for final approval.

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.

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.

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.

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.

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.

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.

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.

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.

Strategic Initiatives

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IDE- In December 2023, the FDA granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device pursuant to the FDA's Breakthrough Devices Program, thereby giving the Company access to the "sprint" rapid review process for IDE comments. For the first two quarters of 2025, the Company has been taking advantage of the process to resolve detailed FDA questions on a variety of topics. We intend to leverage both animal and human therapy, safety, and efficacy data for our FDA IDE application in the third quarter of 2025.

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Commercialization of Human Therapy in India- We are pursuing an expanded permit from the DCGI to conduct clinical trials for commercial applications in India. These new tests will be conducted at a second hospital with a new investigator.

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Vivos India-We have decided to expand our presence in India and then to expand internationally. We are applying to become a Limited Liability Company in India in order to establish a business entity in India.

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Animal Therapy in India- In the second quarter of 2025, we sponsored an animal therapy "Pets in the Park" event with a renowned speaker. There is strong interest to initiate animal therapy in India. We now have solid contacts with interested veterinary clinics. A production site in India would allow us to be cost effective.

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Second Domestic Production Facility- To reduce our risk of a single point of failure at a single production facility in Texas we are negotiating a contract for space at Applied Process Engineering Laboratory (APEL). It will also serve as a production site for our Peltier and Duncan Chillers. We will focus our automative production development at this site, setting the stage for higher volumes in the future. We will continue to use IsoTherapeutics.

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Future Indications for Use and Alternate Isotopes- In December 2024, the Company conducted an offsite strategic meeting with our key technical staff, both our Medical and Veterinary Advisory Boards, our principal investigators from Mayo Clinic and India, and the Chairman of our Board. The objective was to determine our next target indications for use and to ensure that Y-90 was the best therapeutic isotope to treat these cancers.

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.

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.

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.

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:

	●	PrecisionGel- The Company spent years refining the development of its hydrogel, in which gelation initiates at room temperature and is completed as it warms to body temperature. The Company is currently investing in quantifying and controlling the hydrogel resorption and agent dispersal characteristics. There has been enough interest in this component to warrant a serious business case assessment.
		The Company has trademarked the name Precision Gel™ and, in addition to its current hydrogel patent, filed a new provisional patent in January 2025 to cover retention, transport, and release of a broad range of agents. These agents include radioactive and non-radioactive materials, solid particles, including nano-particles, large molecules, small molecules, including liquids, cells, and viruses.

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.

Intellectual Property

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

Our trademark protection, which is extended to 17 countries, has been expanding continuously:

We own applications/registrations for the following as noted below:

	○	ISOPET®
	○	RADIOGEL®
	○	ALPHA-GEL™
	○	BETA-GEL™
	○	GAMMA-GEL™
	○	PRECISION RADIONUCLIDE THERAPY™
	○	PRECISIONGEL™
	○	Peltier Chlller©
	○	Duncan Chiller™

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.

In January 2025 we filed an additional provisional patent on the control, transport, and delivery of PrecisionGel.

Financing and Strategy

In November 2019, the SEC qualified the Company's 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 and amended from time to time thereafter (the "2019 Regulation A+ Offering"). In September 2021, the SEC qualified the Company's offering of Common Stock under Regulation A, which offering was amended from time to time thereafter (the "2021 Regulation A Offering"). On July 17, 2024, the SEC qualified the Company's offering under Regulation A to offer up to $60,000,000 shares of its Common Stock (the "July 2024 Regulation A+ Offering" and, together with the 2019 Regulation A+ Offering and the 2021 Regulation A Offering, the "Regulation A+ Offerings".).

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.

Following receipt of required regulatory approvals and necessary financing to fund our working capital requirements, the Company intends to outsource material aspects of manufacturing, distribution, sales, and marketing for operations within the U.S. Outside of the U.S., the Company intends to pursue licensing arrangements and/or partnerships 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. These long-term goals are subject to the Company: (i) receiving adequate funding; (ii) receiving regulatory approval for RadioGel^™ and other brachytherapy products; and (iii) being able to successfully commercialize its brachytherapy products.

Based on the Company's financial history since inception, the Company's independent registered public accounting firm has expressed substantial doubt as to the Company's ability to continue as a going concern. The Company has limited revenue, nominal cash, and has accumulated deficits since inception. If the Company cannot obtain sufficient additional capital, the Company will be required to delay the implementation of its business strategy and may not be able to continue operations.

The Company's headquarters are in Northeast Washington, however, our focus on the animal therapy market has been the Northwestern sector of the U.S. The Company continues its marketing efforts on the animal therapy market and our attempts to increase the exposure to our product, and generate revenue accordingly.

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.

The Company anticipates using the proceeds from the July 2024 Regulation A+ Offering as follows:

For the animal therapy market:

	●	Expand communication on our website, the Company's social media presence, conferences, and journals, each intended to increase the number of certified clinics for small animal and equine therapy and to increase the number of patients;
	●	Subsidize certain IsoPet® therapies, if necessary, to ensure that all viable candidates are treated; and
	●	Assist a new regional clinic with their license and certification training.

For the human market:

	●	Enhance the pedigree of the Quality Management System;
	●	Begin automation of product manufacturing;
	●	Fund liability insurance for human clinical studies; and.
	●	Fund human clinical studies in the US and India.

Research and development of the Company's precision radionuclide therapy product line has been funded with proceeds from the sale of equity and debt securities, including from the Prior Regulation A+ Offerings. 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: (i) fund the FDA approval process to conduct human clinical trials; (ii) conduct Phase I, pilot, clinical trials; (iii) activate several regional clinics to administer IsoPet^® across the U.S.; (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. The proceeds raised from the prior Regulation A+ Offerings were used to fund this development and proceeds from the July 2024 Regulation A+ Offering will be used to continue such development efforts.

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.

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.

Following receipt of required regulatory approvals and financing, in the U.S., the Company intends to outsource material aspects of manufacturing, distribution, sales and marketing. Outside of the U.S., the Company intends to pursue licensing arrangements and/or partnerships to facilitate its global commercialization strategy.

Long-term, the Company intends to consider resuming research efforts with respect to other products and technologies, such as Gamma Gel and Alpha Gel intended to help improve the diagnosis and treatment of cancer and other illnesses. These long-term goals are subject to the Company: (1) receiving adequate funding; (2) receiving regulatory approval for RadioGel^™ and other precision radionuclide therapy products; and (3) being able to successfully commercialize its precision radionuclide therapy products.

Based on the Company's financial history since inception, the Company's independent registered public accounting firm has expressed substantial doubt as to the Company's ability to continue as a going concern. The Company has limited revenue, nominal cash, and has accumulated deficits since inception. If the Company cannot obtain sufficient additional capital, the Company will be required to delay the implementation of its business strategy and may not be able to continue operations.

The Company's headquarters are in the State of Washington., The initial focus of the animal therapy market has been the Northwestern sector of the United States. The Company has initiated marketing efforts to the animal therapy market in other regions of the United States, attempting to increase the exposure to our product and increase revenue opportunities.

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 not be enough to cover the fixed and variable obligations of the Company. The Company has focused on operating on minimum overhead, including using a virtual office for the last several years and retaining experienced industry consultants available on an as needed basis. This has helped focus the capital received from the Company's Regulation A+ Offerings on activities that enhance our objectives.

There is no guarantee that the Company will be able to raise additional funds or to do so on terms advantageous to the Company's stockholders.

The 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's continuation as a going concern is dependent upon its ability to generate sufficient cash flow to meet its obligations on a timely basis and ultimately to attain profitability. The Company plans to seek additional funding to maintain its operations through debt and equity financing and to improve operating performance through a focus on strategic products and increased efficiencies in business processes and improvements to the cost structure. There can be no assurance that the Company will be successful in its efforts to raise additional working capital or achieve profitable operations. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Available Information

The Company prepares and files annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and certain other information with the SEC. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at http://www.sec.gov. Moreover, the Company maintains a website at http://www.radiogel.com that contains important information about the Company, including biographies of key management personnel, as well as information about the Company's business. This information is publicly available and is updated regularly.

Results of Operations

Comparison of the Six months Ended June 30, 2025 and 2024

The following table sets forth information from our statements of operations for the six months ended June 30, 2025 and 2024:

		Six Months Ended June 30, 2025				Six Months Ended June 30, 2024
Revenues		$	41,748			$	18,000
Cost of goods sold			85,583				16,780
Gross loss			(43,835	)			1,220
Operating expense			(1,494,470	)			(1,100,659	)
Operating loss			(1,538,305	)			(1,099,439	)
Non-operating income (expense)			58,096				37,442
Net loss		$	(1,480,209	)		$	(1,061,997	)

Revenues and Cost of Goods Sold

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.

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.

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.

Operating Expenses

Operating expense for the six months ended June 30, 2025 and 2024, respectively consists of the following:

		Six months ended June 30, 2025				Six months ended June 30, 2024
Professional fees, including stock-based compensation		$	946,723			$	683,452
Payroll expense			187,384				181,753
Research and development			227,246				157,109
General and administrative expense			133,117				78,345
Total operating expense		$	1,494,470			$	1,100,659

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.

Non-Operating Income

Non-operating income for the six months ended June 30, 2025 and 2024 were as follows:

		Six months ended June 30, 2025				Six months ended June 30, 2024
Interest income		$	58,096			$	37,442
Non-operating income (expense)		$	58,096			$	37,442

Non-operating income for the six months ended June 30, 2025 and 2024 related to interest earned on the Company's cash accounts.

Net Loss

Our net loss for the six months ended June 30, 2025 and 2024 was $(1,480,209) and $(1,061,997), respectively.

Comparison of the Three months Ended June 30, 2025 and 2024

The following table sets forth information from our statements of operations for the three months ended June 30, 2025 and 2024:

		Three Months Ended June 30, 2025				Three Months Ended June 30, 2024
Revenues		$	15,000			$	13,500
Cost of goods sold			49,753				10,780
Gross loss			(34,753	)			2,720
Operating expense			(640,019	)			(525,029	)
Operating loss			(674,772	)			(522,309	)
Non-operating income (expense)			29,259				18,851
Net loss		$	(645,513	)		$	(503,458	)

Revenues and Cost of Goods Sold

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.

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.

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.

Operating Expenses

Operating expense for the three months ended June 30, 2025 and 2024, respectively consists of the following:

		Three months ended June 30, 2025				Three months ended June 30, 2024
Professional fees, including stock-based compensation		$	358,454			$	279,814
Payroll expense			92,687				90,628
Research and development			107,965				99,662
General and administrative expense			80,913				54,925
Total operating expense		$	640,019			$	525,029

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.

Non-Operating Income

Non-operating income for the three months ended June 30, 2025 and 2024 were as follows:

		Three months ended June 30, 2025				Three months ended June 30, 2024
Interest income		$	29,259			$	18,851
Non-operating income (expense)		$	29,259			$	18,851

Non-operating income for the three months ended June 30, 2025 and 2024 related to interest earned on the Company's cash accounts.

Net Loss

Our net loss for the three months ended June 30, 2025 and 2024 was $(645,513) and $(503,458), respectively.

Liquidity and Capital Resources

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.

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.

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.

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.

The principal variables in the timing and amount of spending for the brachytherapy products in the next 12 to 24 months will be the FDA's classification of the Company's brachytherapy 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 additional capital raises.

Recent geopolitical events, including the inherent instability and volatility in global capital markets, as well as the lack of liquidity in the capital markets, could also impact the Company's ability to obtain financing and its ability to execute its business plan.

Our Chief Executive Officer currently works from his home office in virtual communication with key personnel. 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.

Accounting Policies and Estimates

The preparation of financial statements and related disclosures in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the unaudited condensed financial statements and accompanying notes. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. Actual results could differ from these estimates under different assumptions or conditions. During the period ended June 30, 2025, we believe there have been no significant changes to the items disclosed as significant accounting policies in management's notes to the financial statements in our annual report on Form 10-K for the year ended December 31, 2024, filed on March 24, 2025.

Off-Balance Sheet Arrangements

The Company does not have any off-balance sheet arrangements that are reasonably likely to have a current or future effect on the Company's financial condition, revenues, results of operations, liquidity or capital expenditures.