UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the fiscal year ended
For the transition period from ______ to_______
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(Exact name of registrant as specified in its charter)
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State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter.
On June 30, 2024, the aggregate market value of our
common stock held by non-affiliates was $
On March 28, 2025, the Registrant had shares of common stock outstanding.
TABLE OF CONTENTS
Cautionary Statement Regarding Forward-Looking Statements
This Annual Report on Form 10-K includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are based on our current expectations and projections about future events. These forward-looking statements are subject to known and unknown risks, uncertainties and assumptions about our Company, our products, the markets in which we compete and general economic conditions that may cause actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “continue,” or the negative of such terms or other similar expressions. Factors that might cause or contribute to such a discrepancy include, but are not limited to, those described in this Annual Report on Form 10-K and in our other Securities and Exchange Commission filings.
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PART I
ITEM 1. BUSINESS.
Background
We are a medical device technology and software as a service (SaaS) company focused on enabling primary care physicians (PCPs) and other healthcare providers to increase their revenues by providing them with relevant, value-based tools to evaluate and treat chronic disease as well as provide preventive care through reimbursable procedures. In some cases, the products we provide our physician clients will enable them to diagnose and treat patients with chronic diseases which they historically have referred to specialists, allowing them to increase their practice revenue. As part of our mission, we are providing PCPs and other healthcare providers with the software, training and devices necessary to allow them to treat their patients using value-based healthcare, informatics and personalized medicine. Our digital healthcare, clinical decision support and point of care solutions also support non face to face remote patient and therapeutic monitoring, to address chronic care and preventive medicine and are reimbursable to the medical practice.
Based on the success of PCPs using our Quality Health System Lab Expert System (“QHSLab”) digital healthcare platform combined with our AllergiEnd® product line, we intend to increase our revenues by charging physicians a monthly subscription fee for the use of QHSLab and soliciting additional PCPs to increase their revenues by using our proven revenue generating QHSLab and AllergiEnd® line of products. We also plan to introduce additional point of care diagnostics and treatments, and digital medicine programs that PCPs and other healthcare providers can use and prescribe in their practices. In all cases, providers will be paid under existing government and private insurance programs, based upon analyses conducted utilizing QHSLab and treatments provided as a result of such analyses.
Industry
The healthcare industry has yet to experience the improvements in outcomes, access, and cost-effectiveness that have transformed many other industries through the use of digital technologies. In an effort to address a worsening pandemic of chronic diseases associated with aging populations, technology companies are now contributing innovative solutions that enhance chronic and preventive care management through the structured capture, storage and analysis of large quantities of patient data, and remote monitoring digital applications to reduce the burden of care on healthcare systems.
Digital medicine products utilizing sophisticated software to capture, store, analyze and access patient data, can be used independently or in concert with pharmaceuticals, biologics, devices, or other products to optimize patient care and health outcomes. A key component of digital medicine is the analysis of raw patient data, including physiological, psychological and environmental signals or responses to digital health risk assessments to provide the physician with result-oriented output to support their clinical decision making and better coordinate patient care and treatment.
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Digital Therapeutics or digital behavioral health, that is, the use of digital medicine products to assess a patient’s state of health and wellbeing and monitor progress in response to recommended lifestyle changes, medication adherence and treatment regimens, is considered a treatment in its own right, and may be reimbursable depending upon a patient’s health condition and diagnosis, giving health-care providers an economic incentive to engage in digital healthcare. We have added and intend to continue to add features to our QHSLab platform which allow PCPs to engage in digital medicine for which they have been and will be reimbursed.
Our Operating Model
Our mission is to enhance the quality of life of individuals and populations through physician-directed digital medicine and innovative, artificial intelligence (AI) enhanced preventive health technologies.
| ● | Value Based. The Company provides tools that enhance health care for patients while lowering costs to insurance providers and corporate America and allowing physicians to increase their practice revenues. | |
| ● | Patient Centered. Our products streamline the relationship between physicians and their patients, providing a high quality experience for patients, and increasing the value provided to them during care. | |
| ● | Time Saving. Physicians can maximize face-to-face office visits and non-face-to-face patient education while generating additional revenue through reimbursable preventative services. | |
| ● | Prevention Focused. Our products are designed to promote prevention, early detection, management, and reversal of chronic diseases. |
QHSLab Expert System
We have developed and are constantly upgrading our high-level, fully automated cloud-based SaaS system named the QHSLab which provides physicians and healthcare organizations with the ability to capture and store patient information electronically in a secure database. The patients’ data is analyzed by specific and proprietary algorithms, assisting the physician in making a diagnosis and prescribing a course of treatment and appropriate care coordination. We provided physicians at practices which use QHSLab with analytical tools to diagnose and treat allergies and asthma which allowed them to increase revenues by expanding the breadth of their practices. Our focus for the immediate future is to increase the number of physicians utilizing the QHSLab platform, to charge users a monthly fee, to expand the number of diagnostic algorithms and health risk assessments incorporated into QHSLab and to add features which allow PCPs to engage in reimbursable forms of digital medicine, thereby enabling general practice physicians to increase their revenues.
Our QHSLab Expert System is capable of handling large quantities of data, without compromising security, accuracy or precision. We can set parameters to accommodate prospective client physician and healthcare organizations’ policies and easily deal with significant increases in user workload. Our cloud-based software and IT system scales to allow a virtually unlimited number of user sessions to be activated. By utilizing a set, well-known path built into our cloud server infrastructure our QHSLab is not only capable of scaling to a large number of users, but is also built on a globally-scalable architecture, allowing us to deliver high availability to users in just about any geographic region.
The importance of identifying particular health risks and the indicators of the risks to be identified vary between different healthcare settings and sectors. Some require psychological data while others require a detailed medical history and list of medications. The data collected and analyzed by our QHSLab and the feedback provided to a physician can be tailored to provide the physician with an individualized assessment tailored to his practice.
Advantages of the QHSLab Expert System
QHSLab has the potential to play the same role in behavioral medicine and lifestyle interventions that pharmacological interventions play in biological medicine. It will help physicians and healthcare organizations overcome barriers preventing adoption of behavioral and therapeutic change programs for health promotion and disease prevention through easy-to-use applications.
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Through purposeful design, the QHSLab Expert System:
| ● | Conducts a comprehensive assessment of patient behaviors, lifestyle and disease risk; | |
| ● | Integrates into existing physician and healthcare interventions; | |
| ● | Collects and compiles relevant, empirical data; | |
| ● | Utilizes this information for decision making; | |
| ● | Accounts for individual differences yet is appropriate for whole populations; | |
| ● | Provides guidelines for consistent decisions; | |
| ● | Demonstrates flexibility by allowing new variables to be added; | |
| ● | Requires relatively low-skilled IT involvement in assessment or patient program development; and | |
| ● | Maximizes revenue by providing less costly ‘digital’ alternatives to face-to-face interactions. |
Our interventions are ideal for population-based approaches. We provide an efficient means of screening. Upon development, our interactive AI based programs will branch into in-depth assessment when a problem area is identified. QHSLab currently includes a large array of lifestyle improvement interventions that can be matched to individual user requirements.
QHSLab has incorporated a wide variety of digital healthcare intervention programs including allergies and asthma, mental health, musculoskeletal health and pain, hypertension, sleep disorders, dietary assessments, weight loss and much more. Our AI driven approaches range from patient treatment seeking interventions and motivational materials for participants in early stages of behavioral change to more detailed advice and support for participants in later stages of behavioral change. As a participant progresses (or regresses), different intervention materials are available.
Our system provides an automated recording device so that minimal amounts of progress can be detected and reinforced. Gathering data through automation provides an extensive empirical data base that can be used to both serve the participant and provide an evaluation of the effectiveness of the treatment regimen. Since health risk prevention can be very expensive in terms of the resources required to provide services to all participants, QHSLab represents a far less costly alternative.
An article in the Journal of the American Medical Association (JAMA) titled ‘Assessment of an Interactive Digital Health–Based Self-management Program to Reduce Hospitalizations Among Patients With Multiple Chronic Diseases’ reported on the success achieved by physicians utilizing a research system similar to QHSLab. The randomized clinical trial found that “among participants who received the internet chronic disease management intervention, fewer were admitted to the hospital” and “digital health interventions supporting patient self-management and self-monitoring has the potential to augment primary care among patients with multiple chronic diseases and co-morbidities.”
Physicians are seeking preventive and chronic care management tools for their medical decision making and patient care, including non-face to face asynchronous interventions and easy to incorporate workflow digital screenings. Today, independent physicians and their practices desire digital health relationships that meet all their needs and those of their patients, instead of having to incorporate multiple limited services from numerous digital health companies. Physicians don’t have time to pick and choose among different digital health systems. QHSLab solves this problem especially for the primary care provider.
AllergiEnd®
The first point of contact for most allergy patients is their primary care doctor or pediatrician. There are approximately 60 million Americans affected by allergic disorders, yet there are fewer than 3,000 practicing Board Certified Allergists and approximately 2,400 Board Certified Otolaryngologists specializing in allergy or approximately 1 specialist for every 11,000 allergy sufferers. It is estimated that the number of full-time equivalent (FTE) allergists/immunologists will decline about 7 percent in coming years. Meanwhile, demand for the services these physicians provide is projected to increase by 35 percent over the foreseeable future.
Only a limited number of primary care physicians have sufficient training to diagnose and treat allergy-suffering patients in their offices. The primary care provider is managing many forms of chronic diseases today that in the past were in the specialist domain, while allergies have remained the exception. We believe there is a need to equip primary care physicians, physician assistants, nurse practitioners, and nurses with the ability to diagnose and treat allergy sufferers and that this need provides a strong economic opportunity for the Company.
The AllergiEnd® system empowers allergist primary care providers with means to test patients for a broad spectrum of allergens within the confines of their office, thereby enabling the physician to identify the specific cause of the patient’s allergies which can lead to targeted allergen immunotherapy treatment as opposed to merely masking symptoms with various anti-histamines. The product line consists primarily of a disposable, one-time use set of FDA cleared and patented skin test applicators and a unique patented test tray for use with the test applicators.
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As part of our service, we provide physicians and their staff with the know-how and training in allergy screening via the QHSLab digital medicine platform, skin test confirmation of the particular allergen causing the allergy symptoms and targeted allergen immunotherapy necessary to enable the physician to desensitize positive allergic patients, thereby treating the cause of the allergies, not merely the symptoms. AllergiEnd® allergen immunotherapies are pharmacy compounded preparations provided by a contract pharmacy in response to prescriptions given by the treating physicians that slowly expose the patient to small doses of the allergen culprit, either via subcutaneous injections in the doctor’s office or through convenient at home sublingual (under the tongue) oral drops. This approach is similar, if not identical, to that used by allergists the world over for many years. This builds the body’s immune system to the allergens, thereby overcoming the patient’s excessive reaction to allergens that were previously causing allergy symptoms. Allergen Immunotherapy practiced safety is the only known method of treatment that leads to prolonged tolerance to the allergens causing the patient’s allergic chronic disease. In addition to enhancing the level of care doctors can provide their patients; the screening, testing and allergen immunotherapy are reimbursable under established CPT codes enhancing the physician’s practice and, in many instances, also providing a new cash pay alternative for physicians and their patients.
Q-Scale Psychological Emotional Wellbeing
It has been suggested that nearly 75% of all medical office visits (to all types of healthcare providers) are related to stress, anxiety and depression.
| ● | “Q” stands for Quality of Life, and the Q-Scale measures a patient’s responses (or early “warning” signs) to questions regarding their sleep, stress, anxiety, worry, pain, and overall life satisfaction. Patients with high mental health risks are flagged for further screening during the same assessment. |
The Q-Scale is a digital health 10-item questionnaire designed to measure psycho-emotional factors in patients at risk of mental health issues.
| ● | Five categorical ratings are available for response to each item, ranging from “none of the time” to “all of the time.” If responses to the Q-Scale indicate potential mental health troubles, patients are directed to the Kessler 6 questions within the assessment to identify their risk of anxiety and depression for further clinical evaluation. Responses then categorize the patient as “at-risk” for mental health issues, including depression. Then the treating physician will be informed through a simple-to-read report of the need for more focused evaluation during their encounter with the patient. |
This assessment provides immediate feedback to patients while allowing for substantial reimbursements for physicians.
| ● | Patients are provided with a comprehensive, yet easy to interpret report based on their responses, providing supportive self-management strategies to improve their coping skills and wellbeing. The Q-Scale aligns with CPT codes, which are used when tests are administered by a physician or other qualified healthcare professional. It is defined as “psychological or neuropsychological test administration / scoring by a physician or other qualified healthcare professional, two or more tests, any method.” |
For our physician customers, the product is time-saving, maximizing face-to-face office visits while generating additional revenue through reimbursement codes accepted by commercial payors, Medicare and Medicaid. From a patient perspective, Q-Scale promotes early detection and treatment of conditions potentially related to stress, anxiety, or depression, and increases the value provided to patients during their care.
Industry trends also reinforce the growing need for new and time-sensitive approaches for the treatment of mental health-related issues. According to the Centers for Disease Control and Prevention, one in five Americans will experience a mental illness in a given year. Also, one in 25 Americans will be impacted by a severe mental illness, such as schizophrenia, bipolar disorder, or major depression. In addition, a recent study published by KFF, a non-profit organization focused on health-care issues, indicated that the COVID-19 pandemic and resulting economic recession have negatively affected many people’s mental health with up to 40% of people reporting anxiety and depressive-related symptoms.
Key aspects of the Q-Scale product include:
● Utilizes QHSLab’s cloud-based software and technology system that scales to allow a virtually unlimited number of user sessions to be activated and integrates into existing physician and healthcare interventions while collecting and compiling relevant, empirical data.
● Measures a patient’s responses, identifying early “warning” signs using questions regarding their sleep, stress, anxiety, worry, pain and overall life satisfaction. Patients determined to have high mental health risks are identified for further screening during the same assessment. Items in the Q-Scale have been deliberately written to emphasize normal psychological functioning in generally healthy patients, therefore it is a total population screening tool.
● If responses to the Q-Scale indicate potential mental health issues, patients are directed to the PHQ-9, GAD-7 and Kessler 6, a global measure of distress drawing from depressive and anxiety related symptomology. The treating physician is then alerted to the need for more focused evaluation during their encounter with the patient.
● Patients receive a post-assessment digital ‘feedback’ report and self-management strategies useful in addressing any items identified during the assessment.
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Executing on our Growth Strategy
| Growing Recurring Revenue Base | ● | Increasing the number of medical practitioners utilizing our point-of-care and digital medicine services, growing our revenue per client metric. |
| ● | Future distribution channels include Management Service Organization (MSO) partnerships, Independent Physician Associations (IPA’s), and complementary digital health networks. | |
| Expanding Product Portfolio | ● | Additional point-of-care diagnostic, digital medicine, and treatments that PCPs can use, prescribe, and be reimbursed for under existing government and private insurance programs. |
| Increasing Industry Visibility | ● | Increasing the number of company/university-sponsored medical conferences partnering with various Universities to introduce and educate members of the medical community about the technology and revenue opportunities available. |
Competition
The market for future point of care and software as a service solution is highly competitive and characterized by rapid change. The success of our solutions will be contingent upon our ability to provide superior solutions and a strong value proposition for potential customers and their patients. Many existing competitors are well-established and enjoy greater resources or other strategic advantages. It is likely that there will be new entrants into our market, some of which may become significant competitors. With the introduction of new technologies and market entrants, we expect the competitive environment to be and remain intense. We currently face competition from a range of companies, including Phresia, Qure4U, Linus Health, Chadis, Yosi Health, Greenway Health and Health Note, some of which market direct to the consumer, bypassing physicians.
Our main competitors fall into the following categories:
● private and public companies that offer specific chronic disease products and services, such as solutions for allergies and asthma, diabetes, hypertension, and certain addictions or behavioral health conditions;
● large enterprises focused on the healthcare industry, including initiatives and partnerships launched by companies which may offer or develop products or services with features or benefits that overlap with our proposed future solutions; and
● digital health, electronic records, device manufacturers that facilitate the collection of data but offer limited interpretation, feedback or guidance.
Many of our current competitors enjoy greater resources, recognition, deeper customer relationships, larger existing customer bases, and more mature intellectual property portfolios than we do currently.
Intellectual Property
Although certain of our current software applications and pioneering methods, as well as those developed in the future, will be eligible for patent and trademark protection, we believe that the costs of maintaining and enforcing such intellectual property rights may not afford us a competitive advantage and for the immediate future we intend to rely primarily on maintaining the secrecy of our proprietary information.
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Government Regulation
The healthcare industry is heavily regulated and closely scrutinized by federal, state and local governments. Comprehensive statutes and regulations govern the manner in which we and the PCPs which use our products provide and bill for services and collect reimbursement from governmental programs and private payors, our contractual relationships with vendors and clients, our marketing activities and other aspects of our operations. Of particular importance are:
| ● | the federal physician self-referral law, commonly referred to as the Stark Law; | |
| ● | the federal Anti-Kickback Act; | |
| ● | the criminal healthcare fraud provisions of HIPAA; | |
| ● | the federal False Claims Act; | |
| ● | reassignment of payment rules that prohibit certain types of billing and collection by companies which do business with PCPs; | |
| ● | similar state law provisions pertaining to anti-kickback, self-referral and false claims issues; | |
| ● | state laws that prohibit general business corporations, such as us, from practicing medicine; and | |
| ● | laws that regulate debt collection practices as applied to our debt collection practices. |
Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. Dealing with investigations can be time- and resource-consuming and can divert management’s attention from our business.
The FDA issued a Finalized Guidance on medical mobile applications (“Apps”). The FDA determined that certain Apps may meet the definition of a medical device because they provide the user with certain biologic information. The Guidance contains an appendix that provides examples of mobile apps that may meet the definition of a medical device but for which the FDA intends to exercise enforcement discretion. These mobile apps may be intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. Even though these mobile apps may meet the definition of a medical device, the FDA intends to exercise enforcement discretion for these mobile apps because they pose lower risk to the public. Based on our understanding of the Guidance, although there can be no guarantee, we believe our QHSLab services will eventually be subject to regulatory requirements because such services seem to fall within the statutory examples of medical devices with respect to which the FDA intends to monitor compliance with applicable regulations. Although many of the Apps described in the Guidance have been in use for an extended period of time, the impact they have had on the need for patient visits to a physician and thus, on the use of our products, has not been determined.
Employees
As of March 28, 2025, we had four employees devoting full-time services to the Company, all of whom were engaged in direct sales and operations. In addition, we engage independent entities and consultants that provide programming services, Quality Management System development, Marketing and Medical Consulting & Advisory services. We believe that our relationships with our employees and consultants are good.
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ITEM 1A. RISK FACTORS.
You should carefully consider each of the following risks and all of the other information set forth in this annual report. The following risks relate principally to our business and our common stock. These risks and uncertainties are not the only ones facing our company. Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may also adversely affect our business. If any of the risks and uncertainties develop into actual events, this could have a material adverse effect on our business, financial condition or results of operations. In that case, the trading price of our common stock could decline. Please also see the section “Government Regulation” above.
Risks Related to Our Business
We incurred net losses in 2024 and 2023 and may not be able to continue to operate as a going concern.
We suffered net losses of $259,239 and $468,362 for the years ended December 31, 2024 and 2023, respectively. We also had positive cash flows from operations for the year ended December 31, 2024 but had negative cash flows from operations for the year ended December 31, 2023. During the years ended December 31, 2024 and 2023, to support our operations we received loans in the aggregate amount of $548,736. The report of our independent registered public accountants on our consolidated financial statements for the year ended December 31, 2024 states that these factors raise uncertainty about our ability to continue as a going concern.
Unless we are able to generate positive cash flows from operations, we will continue to depend upon further issuances of debt, equity or other financings to fund ongoing operations. We may continue to incur additional operating losses and we cannot assure you that we will continue as a going concern.
We are highly leveraged and we need additional financing.
We have funded our operating losses through borrowings, and merchant cash advances. As of the date of this annual report we have notes and loans outstanding in the aggregate amount, inclusive of accrued interest, of $2,061,988. Our Original Issue Discount Secured Convertible Promissory Note in the principal amount of $440,000 matured on July 22, 2023 and our Original Issue Discount Secured Convertible Promissory Note in the remaining principal amount of $695,500 matured on August 10, 2022 and remain unpaid. On March 27, 2024, the Company received the most recent notice from the manager of the Mercer Fund of its agreement to forebear from the exercise of any rights it might have as a result of any defaults under this Note and the related documents between us and the Mercer Fund, provided that the Mercer Fund reserved all of its rights under such agreements. The Note continued to accrue interest at 5%. On February 20, 2025, the Company received a Notice of Default from Mercer Street Global Opportunity Fund, LLC (the “Lender”) in connection with the $806,000 Note and the $440,000 Note. Under the terms of the Notes, a failure to pay the principal and interest when due constitutes an Event of Default under the Notes. The Company has accrued default interest of 18% as of December 31, 2024 for these notes. See Note 7 Convertible Notes Payable for additional information regarding these notes.
If we are not able to pay or refinance the outstanding principal and accrued interest on these notes the Lender may choose to exercise such rights as are available to it including foreclosing upon our assets, our management may be required to devote time to dealing with such efforts and our operations may be materially and adversely affected. We may need to offer the holders of our debt increases in the rates of interest they receive or otherwise compensate them through payments of cash or issuances of our equity securities or reductions in the price at which they can convert their convertible securities. Future financings or re-financings may involve the issuance of additional debt, equity and securities convertible into or exercisable for our equity securities. If we are unable to consummate such financings or re-financings, our operations and the trading price of our common stock could be adversely affected and the terms of such financings may adversely affect the interests of our existing stockholders. Our inability to obtain additional working capital is restricting our ability to grow our business as rapidly as otherwise might be possible and could have a material adverse affect on our business and financial condition and may result in a decline in the price of our common stock. If we are not able to fund ongoing losses through funds provided by third parties or our principal shareholder, we may become insolvent.
Servicing our debt requires a significant amount of cash.
Our ability to make payments on and to refinance our debt, to fund planned capital expenditures and to maintain sufficient working capital depends on our ability to generate cash in the future. This is subject to numerous factors beyond our control, including our ability to expand our physician client base. We cannot assure you that our business will generate sufficient cash flow from operations or financings in an amount sufficient to enable us to service our debt or to fund our other liquidity needs. If our cash flow and capital resources are insufficient to allow us to make scheduled payments on our debt or otherwise satisfy our lenders, we will need to seek additional capital or restructure or refinance all or a portion of our debt, any of which could have a material adverse effect on our business, financial condition or results of operations. We cannot assure you that we will be able to refinance any of our debt on commercially reasonable terms or at all. If we are unable to generate sufficient cash flow to repay or refinance our debt on favorable terms, it could significantly adversely affect our financial condition and the value of our outstanding debt and common stock. Our ability to restructure or refinance our debt will depend on the condition of the capital markets and our financial condition. Any refinancing of our debt could be at higher interest rates and could require us to issue to the holders additional shares of our common stock and may require us to comply with more onerous covenants, which could further restrict our business operations. There can be no assurance that we will be able to obtain any financing when needed.
Our leverage is adversely affecting our ability to finance future operations and capital needs and may limit our ability to pursue business opportunities.
We are an early stage company with a short operating history and a relatively new business model in an emerging and rapidly evolving market, which makes it difficult to evaluate our future prospects.
We are an early stage entity subject to all of the risks inherent in a young business enterprise, such as, lack of market recognition and limited banking and financial relationships. We have little operating history to aid in assessing our future prospects. We will encounter risks and difficulties as an early stage company in a new and rapidly evolving market. We may not be able to successfully address these risks and difficulties, which could materially harm our business and operating results.
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We are not generating sufficient revenues to achieve our business plan.
We first generated revenues in the fourth quarter of 2020. There is no assurance that we will generate sufficient revenues to become or remain cash flow positive or ever be profitable or to satisfy our lenders and maintain our operations. If planned operating levels are changed, higher operating costs encountered, more time needed to implement our plan, or less funding is received, more funds than currently anticipated may be required. If additional capital is not available when required, if at all, or is not available on acceptable terms we may be forced to modify or abandon our business plans.
We have identified material weaknesses in our internal controls, and we cannot provide assurances that these weaknesses will be effectively remediated or that additional material weaknesses will not occur in the future. If our internal control over financial reporting or our disclosure controls and procedures are not effective, we may not be able to accurately report our financial results, prevent fraud, or file our periodic reports in a timely manner, which may cause investors to lose confidence in us and lead to a decline in our stock price. We cannot remedy the deficiencies in our internal controls until we increase the number of officers in our Company.
Our management is responsible for establishing and maintaining adequate internal control over our financial reporting, as defined in Rule 13a-15(f) under the Exchange Act. We have identified material weaknesses in our internal controls with respect to our segregation of duties, which cannot be rectified until we have additional officers. As a result of our limited resources and our insufficient controls over review of accounting for certain complex transactions, our disclosure controls and procedures are not effective in providing material information required to be included in our periodic SEC filings on a timely basis and to ensure that information required to be disclosed in our periodic SEC filings is accumulated and communicated to our management to allow timely decisions regarding required disclosure about our internal control over financial reporting. Some of the material weaknesses in our internal controls are due to our limited management staff. Due to limited staffing, we are not always able to detect errors or omissions in financial reporting and cannot eliminate weaknesses due to our inability to segregate duties. If we fail to comply with the rules under Sarbanes-Oxley related to disclosure controls and procedures in the future or continue to have material weaknesses and other deficiencies in our internal control and accounting procedures and disclosure controls and procedures, our stock price could decline significantly and raising capital could be more difficult. If additional material weaknesses or significant deficiencies are discovered or if we otherwise fail to address the adequacy of our internal control and disclosure controls and procedures our business may be harmed. Moreover, effective internal controls are necessary for us to produce reliable financial reports and are important to helping prevent financial fraud. If we cannot provide reliable financial reports or prevent fraud, our business and operating results could be harmed, investors could lose confidence in our reported financial information, and the trading price of our securities could drop significantly.
All of our revenues have been generated from a limited number of product lines.
To date, all of our revenue has been derived from a limited number of product lines. If we fail to develop or acquire additional products or services from which we can generate revenues, we may not achieve sustained positive cash flow or generate profits. As a result, we will be severely constrained in our ability to fund our operations and achieve our business plan.
We are dependent upon third parties for our products.
We depend upon third parties to supply us with all of the products included in the “AllergiEnd” line of products from which we currently derive most of our revenues. If these parties were unable or unwilling to continue to supply our needs, we might not be able to find an alternative source of supply which would materially adversely impact our business, financial condition and operating results.
We have engaged in limited product development activities and our product development efforts may not result in commercial products.
Although our QHSLab has been provided to physicians and enabled them to generate revenues, we have only recently begun to charge physicians for this product under various software as a service, subscription and license-based revenue models. We intend to develop additional features to be added to QHSLab to provide PCPs with additional sources of revenue. There is no assurance that any of the new features we develop will gain market acceptance. We cannot guarantee we will be able to produce commercially successful products. Further, our eventual operating results could be susceptible to varying interpretations by potential customers, or scientists, medical personnel, regulatory personnel, statisticians and others, which may delay, limit or prevent executing our proposed business plan.
There is no assurance we can generate significant positive cash flow or operating profits as our operations grow.
We are subject to all the risks inherent in a new business. There can be no assurance that our business model will prove successful as we seek to expand the number of our customers and increase our management and staff or that we will achieve significant revenue or profitability.
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If we fail to raise additional capital, our ability to implement our business plan and strategy could be compromised.
We have limited capital resources and operations. To date, our operations primarily have been funded from capital contributions and loans from our principal shareholder and more recently, third party loans. We may not be able to obtain additional financing on terms acceptable to us, or at all. Even if we obtain financing for our near-term operations and product development, we may require additional capital beyond the near term. If we are unable to raise capital when needed, our business, financial condition and results of operations would be materially adversely affected, and we could be forced to reduce or discontinue our operations.
If we issue additional shares of common stock, it would reduce our stockholders’ percent of ownership and may dilute our share value.
Our Certificate of Incorporation authorizes the issuance of 900 million shares of common stock. As at March 28, 2025 we have outstanding 11,281,527 shares of common stock, without giving effect to shares issuable upon conversion or exercise of convertible notes, preferred stock, options and warrants currently outstanding. The future issuance of common stock or securities exercisable for or convertible into common stock to raise capital may result in substantial dilution in the percentage of our common stock held by our then existing stockholders. We may value any common stock issued in the future on an arbitrary basis. The issuance of common stock upon the conversion or exercise of outstanding notes and warrants, for future services or acquisitions or other corporate actions may have the effect of diluting the value of the shares held by our then existing stockholders and might have an adverse effect on any trading market for our common stock.
Dependence on Key Existing and Future Personnel.
Our success depends, to a large degree, upon the efforts and abilities of Troy Grogan, our sole officer, and key consultants. The loss of the services of one or more of our key providers could have a material adverse effect on our operations. In addition, as our business model is implemented, we will need to recruit and retain additional management, financial personnel, key employees and consulting service providers in virtually all phases of our operations. Key employees and consultants will require a strong background in our industry. We cannot assure that we will be able to successfully attract and retain key personnel.
Our sole officer and director is engaged in other business activities and has a conflict in determining how much time to devote to our affairs. His failure to devote sufficient time to our business could have a negative impact on our operations.
Our sole executive officer and director is not required to, and will not, commit his full time to our affairs, which results in a conflict of interest in allocating his time between our operations and the other businesses in which he is engaged. Our sole executive officer and director is engaged in several other business endeavors and is not obligated to contribute any specific number of hours to our affairs. His failure to devote time to our business could have an adverse impact on our business, results of operations and financial condition.
We operate in a highly competitive industry.
We encounter competition from local, regional or national entities, some of which have superior resources or other competitive advantages. Intense competition may adversely affect our business, financial condition or results of operations. Our competitors may be larger and more highly capitalized, with greater name recognition. We will compete with such companies on brand name, quality of services, level of expertise, advertising, product and service innovation and differentiation of product and services. As a result, our ability to secure significant market share may be impeded.
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We face substantial competition, and others may discover, develop, acquire or commercialize competitive products before or more successfully than we do.
We operate in a highly competitive environment. Our products compete with other products or treatments for diseases for which our products may be indicated. Other healthcare companies have greater clinical, research, regulatory and marketing resources than us. In addition, some of our competitors may have technical or competitive advantages for the development of technologies and processes. These resources may make it difficult for us to compete with them to successfully discover, develop and market new products.
The growth of our business relies, in part, on the growth and success of our clients.
The utility of our products to our clients will be determined by their ability to incorporate them into their health care regimen and the acceptance of our products by their patients. The ability of our clients to incorporate our products into their practices is outside of our control. In addition, if the number of patients of one or more of our clients using our products were to be reduced, such decrease would lead to a decrease in our revenue.
We conduct business in a heavily regulated industry and if we fail to comply with applicable laws and government regulations, we could incur penalties or be required to make significant changes to our operations or experience adverse publicity, which could have a material adverse effect on our business, financial condition, and results of operations.
The healthcare industry is heavily regulated and closely scrutinized by federal, state and local governments. Comprehensive statutes and regulations govern the products we offer and the manner in which we provide and bill for services and collect reimbursement from governmental programs and private payors, our contractual relationships with our providers, vendors and clients, our marketing activities and other aspects of our operations. Of particular importance are:
| ● | the federal physician self-referral law, commonly referred to as the Stark Law; | |
| ● | the federal Anti-Kickback Act; | |
| ● | the criminal healthcare fraud provisions of HIPAA; | |
| ● | the federal False Claims Act; | |
| ● | reassignment of payment rules that prohibit certain types of billing and collection; | |
| ● | similar state law provisions pertaining to anti-kickback, self-referral and false claims issues; | |
| ● | state laws that prohibit general business corporations, such as us, from practicing medicine; and | |
| ● | laws that regulate debt collection practices as applied to our debt collection practices. |
Some of our business activities could be subject to challenge under one or more of such laws. Achieving and sustaining compliance with these laws may prove costly. Failure to comply with these laws and other laws can result in civil and criminal penalties such as fines, damages, overpayment recoupment, loss of enrollment status and exclusion from the Medicare and Medicaid programs. The risk of our being found in violation of these laws and regulations is increased by the fact that many of their provisions are open to a variety of interpretations. Our failure to accurately anticipate the application of these laws and regulations to our business or any other failure to comply with regulatory requirements could create liability for us and negatively affect our business. Any action against us for violation of these laws or regulations, even if we successfully defend against it, could cause us to incur significant legal expenses, divert our management’s attention from the operation of our business and result in adverse publicity. Dealing with investigations can be time- and resource-consuming. Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business. In addition, because of the potential for large monetary exposure under the federal False Claims Act, which provides for treble damages and mandatory minimum penalties of $5,500 to $11,000 per false claim or statement, healthcare providers often resolve allegations without admissions of liability for significant and material amounts to avoid the uncertainty of treble damages that may be awarded in litigation proceedings. Such settlements often contain additional compliance and reporting requirements as part of a consent decree, settlement agreement or corporate integrity agreement. It is expected that the government will continue to devote substantial resources to investigating healthcare providers’ compliance with the healthcare reimbursement rules and fraud and abuse laws. The laws, regulations and standards governing the provision of healthcare services may change significantly in the future.
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Developments in the healthcare industry could adversely affect our business.
Developments in the healthcare industry and evolving government policy have adversely affected healthcare spending and may adversely impact reimbursement for healthcare services. We expect that we will be particularly dependent on primary care physicians and possibly others in the healthcare industry who are dependent upon revenues derived from federal healthcare programs and payments from health insurers.
General reductions in expenditures by healthcare industry participants could result from, among other things:
| ● government or private initiatives that affect the manner in which healthcare providers interact with patients, payers or other healthcare industry participants, including changes in pricing or means of delivery of healthcare products and services; | |
| ● consolidation of healthcare industry participants; | |
| ● reductions in governmental funding for healthcare; | |
| ●adverse changes in business or economic conditions affecting healthcare payers or providers, pharmaceutical, biotechnology or medical device companies or other healthcare industry participants; and | |
| ● restructuring of the healthcare industry and possible elimination of private insurers. |
Even if general expenditures by industry participants remain the same or increase, developments in the healthcare industry may result in reduced spending for the products or services we provide. The use of our products and services could be affected by changes in health insurance plans resulting in a decrease in the willingness of PCPs to purchase our products.
The timing and impact of developments in the healthcare industry are difficult to predict. We cannot assure you that the markets for any products we may seek to distribute and services we provide will be sustained.
Our use and disclosure of personally identifiable information, including health information, is subject to federal and state privacy and security regulations, and our failure to comply with those regulations or to adequately secure the information we hold could result in significant liability or reputational harm and, in turn, a material adverse effect on our client base, membership base and revenue.
Numerous state and federal laws and regulations govern the collection, dissemination, use, privacy, confidentiality, security, availability and integrity of personally identifiable information (PII), including protected health information (PHI). HIPAA establishes a set of basic national privacy and security standards for the protection of PHI, by health plans, healthcare clearinghouses and certain healthcare providers, referred to as covered entities, and the businesses with which covered entities contract for services, which includes us. HIPAA requires companies like us to develop and maintain policies and procedures with respect to PHI, including the adoption of administrative, physical and technical safeguards to protect such information. HIPAA imposes mandatory penalties for certain violations which can be significant. HIPAA mandates that the Secretary of Health and Human Services, or HHS conduct periodic compliance audits of HIPAA covered entities or business associates. It also tasks HHS with establishing a methodology whereby individuals who were the victims of breaches of unsecured PHI may receive a percentage of the Civil Monetary Penalty fine paid by the violator. HIPAA further requires that patients and, in some instances, HHS be notified of any unauthorized acquisition, access, use or disclosure of their unsecured PHI that compromises the privacy or security of such information, with certain exceptions. Numerous other federal and state laws protect the confidentiality, privacy, availability, integrity and security of PHI. These laws in many cases are more restrictive than, and may not be preempted by, HIPAA, creating complex compliance issues for us and our clients potentially exposing us to additional expense, adverse publicity and liability. If we do not comply with existing or new laws and regulations related to PHI, we could be subject to criminal or civil sanctions. Because of the extreme sensitivity of the PHI we store and transmit, the security features of our technology platform are very important. If our security measures, some of which are managed by third parties, are breached or fail, unauthorized persons may obtain access to sensitive client and patient data, including HIPAA-regulated PHI. As a result, our reputation could be severely damaged, adversely affecting client and patient confidence. Clients may curtail their use of or stop using our services or our client base could decrease, which would cause our business to suffer. In addition, we could face litigation, damages for contract breach, penalties and regulatory actions for violation of HIPAA and other applicable laws or regulations and significant costs for remediation, notification to individuals and for measures to prevent future occurrences. Any security breach could also result in increased costs associated with liability for stolen assets or information, repairing system damage that caused by such breaches, incentives offered to clients or other business partners in an effort to maintain business relationships after a breach and implementing measures to prevent future occurrences, including organizational changes, deploying additional personnel and protection technologies, training employees and engaging third-party experts and consultants. While we maintain insurance covering certain security and privacy damages and claim expenses, we may not carry insurance or maintain coverage sufficient to compensate for all liability and in any event, insurance coverage would not address the reputational damage that could result from a security incident. We outsource important aspects of the storage and transmission of client and patient information, and thus rely on third parties to manage functions that have material cyber-security risks. We attempt to address these risks by requiring outsourcing subcontractors who handle client and patient information to sign business associate agreements contractually requiring those subcontractors to adequately safeguard personal health data to the same extent that applies to us and in some cases by requiring such outsourcing subcontractors to undergo third-party security examinations. However, we cannot assure you that these contractual measures and other safeguards will adequately protect us from the risks associated with the storage and transmission of client and patient proprietary and protected health information.
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The security of our platform, networks or computer systems may be breached, and any unauthorized access to our customer data will have an adverse effect on our business and reputation.
The use of our products will involve the storage, transmission and processing of our clients’ and their patients’ private data. Individuals or entities may attempt to penetrate our network or platform security, or that of our third-party hosting and storage providers, and could gain access to our clients’ and their patients’ private data, which could result in the destruction, disclosure or misappropriation of proprietary or confidential information of our clients’ and their patients’ or their customers, employees and business partners. If any of our clients’ private data is leaked, obtained by others or destroyed without authorization, it could harm our reputation, we could be exposed to civil and criminal liability, and we may lose our ability to access private data, which will adversely affect the quality and performance of our platform. In addition, our platform may be subject to computer malware, viruses and computer hacking, fraudulent use attempts and phishing attacks, all of which have become more prevalent. Any failure to maintain the performance, reliability, security and availability of our products or services and technical infrastructure to the satisfaction of our clients may harm our reputation and our ability to retain existing customers and attract new users. While we will implement procedures and safeguards that are designed to prevent security breaches and cyber-attacks, they may not be able to protect against all attempts to breach our systems, and we may not become aware in a timely manner of any such security breach. Unauthorized access to or security breaches of our platform, network or computer systems, or those of our technology service providers, could result in the loss of business, reputational damage, regulatory investigations and orders, litigation, indemnity obligations, damages for contract breach, civil and criminal penalties for violation of applicable laws, regulations or contractual obligations, and significant costs, fees and other monetary payments for remediation. If customers believe that our platform does not provide adequate security for the storage of sensitive information or its transmission over the Internet, our business will be harmed. Customers’ concerns about security or privacy may deter them from using our platform for activities that involve personal or other sensitive information.
Because we rely on the internet to interact with our clients, we are subject to an extensive and highly-evolving regulatory landscape and any adverse changes to, or our failure to comply with, any laws and regulations could adversely affect our brand, reputation, business, operating results, and financial condition.
Our business and the businesses of our customers conducted using our platform and technology, are subject to extensive laws, rules, regulations, policies, orders, determinations, directives, treaties, and legal and regulatory interpretations and guidance directed to those who conduct business over the internet, including those governing privacy, data governance, data protection, cybersecurity, fraud detection, payment services, consumer protection and tax. Many of these legal and regulatory regimes were adopted prior to the advent of the internet, mobile technologies, digital assets, and related technologies. As a result, they are subject to significant uncertainty, and vary widely across U.S. federal, state, and local jurisdictions. These legal and regulatory regimes, including the laws, rules, and regulations thereunder, evolve frequently and may be modified, interpreted, and applied in an inconsistent manner from one jurisdiction to another, and may conflict with one another. To the extent we have not complied with such laws, rules, and regulations, we could be subject to significant fines, revocation of licenses, limitations on our products and services, reputational harm, and other regulatory consequences, each of which may be significant and could adversely affect our business, operating results, and financial condition.
In addition to existing laws and regulations, various governmental and regulatory bodies, including legislative and executive bodies, in the United States may adopt new laws and regulations, or new interpretations of existing laws and regulations may be issued by such bodies or the judiciary, which may change how we operate our business, how our products and services and those of our customers are regulated, and what products or services we and our competitors can offer, requiring changes to our compliance and risk mitigation measures
To the extent we use “open source” software, our use could adversely affect our ability to offer our services and subject us to possible litigation.
We may use open source software in connection with our products and services. Companies that incorporate open source software into their products have, from time to time, faced claims challenging the use of open source software and/or compliance with open source license terms. As a result, we could be subject to suits by parties claiming ownership of what we believe to be open source software or claiming noncompliance with open source licensing terms. Some open source software licenses require users who distribute software containing open source software to publicly disclose all or part of the source code to such software and/or make available any derivative works of the open source code, which could include valuable proprietary code of the user, on unfavorable terms or at no cost. While we monitor the use of open source software and try to ensure that none is used in a manner that would require us to disclose our proprietary source code or that would otherwise breach the terms of an open source agreement, such use could inadvertently occur, in part because open source license terms are often ambiguous. Any requirement to disclose our proprietary source code or pay damages for breach of contract could have a material adverse effect on our business, financial condition and results of operations and could help our competitors develop products and services that are similar to or better than ours.
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Assertions by third parties of infringement or other violations by us of their intellectual property rights could result in significant costs and harm our business and operating results.
Our success depends upon our ability to refrain from infringing upon the intellectual property rights of others. Some companies, including some of our competitors, own large numbers of patents, copyrights and trademarks, which they may use to assert claims against us. As we grow and enter new markets, we will face a growing number of competitors. As the number of competitors in our industry grows and the functionality of products in different industry segments overlaps, we expect that software and other solutions in our industry may be subject to such claims by third parties. Third parties may in the future assert claims of infringement, misappropriation or other violations of intellectual property rights against us. We cannot assure you that infringement claims will not be asserted against us in the future, or that, if asserted, any infringement claim will be successfully defended. A successful claim against us could require that we pay substantial damages or ongoing royalty payments, prevent us from offering our services, or require that we comply with other unfavorable terms. We may also be obligated to indemnify our customers or business partners or pay substantial settlement costs, including royalty payments, in connection with any such claim or litigation and to obtain licenses, modify applications or refund fees, which could be costly. Even if we were to prevail in such a dispute, any litigation regarding our intellectual property could be costly and time-consuming and divert the attention of our management and key personnel from our business operations.
Natural disasters, unusually adverse weather conditions, pandemic outbreaks, terrorist acts, conflicts between nations and the response of governments to such occurrences, could impair our ability to purchase, receive or replenish inventory or raw materials or could cause US agencies and insurance companies to modify reimbursement policies, which could result in lost sales, reduced revenues and otherwise adversely affect our financial performance.
The occurrence of one or more natural disasters, unusually adverse weather conditions, pandemic outbreaks, such as the recent outbreak of the coronavirus, or COVID-19, terrorist acts, conflicts between nations or rogue groups, and the response of governments and US agencies to such occurrences, could adversely affect our operations and financial performance. To the extent these events impact one or more of our key suppliers, our operations and financial performance could be materially adversely affected through lost sales. Such events could also cause US agencies and insurance companies to modify reimbursement policies which could result in lost sales, reduced revenues and otherwise adversely affect our financial performance.
Our ability to finance our business may be materially adversely affected by global geopolitical conditions including those resulting from the ongoing Russia-Ukraine conflict, the Israel-Hamas conflict, efforts by terrorist organizations to disrupt global shipping patterns and actions by the United States government to reduce its deficit and influence actions of other nations.
Global markets are experiencing volatility and disruption as a result of the geopolitical instability resulting from the ongoing Russia-Ukraine conflict, the Israel-Hamas conflict, efforts by terrorist organizations to disrupt global shipping patterns and recent actions by the United States government, including the reduction in the number of federal employees, the elimination of government programs and the imposition of tariffs. The invasion of Ukraine by Russia, the Israel-Hamas conflict, efforts to disrupt shipping through the Suez Canal and the resulting measures that have been taken, and could be taken in the future, by NATO, the United States, the United Kingdom, the European Union, Israel and other countries and recent actions taken by the United States government to reduce the number of federal employees, eliminate government programs and impose tariffs, have created global economic and security concerns that could have a lasting impact on regional and global economies and financial markets. Although the length and impact of the ongoing conflicts and any sanctions imposed and actions which may be taken by the United States government are highly unpredictable, they have led to market disruptions and could result in further disruptions, including significant volatility in commodity prices, credit and capital markets and lead to instability and lack of liquidity in capital markets, adversely impacting our ability to finance our operations. The imposition of tariffs on products imported by us or our physicians in providing services to their patients, may increase costs and may have an adverse impact on their practices and our business and financial results.
Risks Related to Regulation
Our products may be subject to product liability legal claims, which could have an adverse effect on our business, results of operations and financial condition.
Certain of our products provide applications that relate to patient clinical information. Any failure by our products to provide accurate and timely information concerning patients, their medication, treatment and health status, generally, could result in claims against us which could materially and adversely impact our financial performance, industry reputation and ability to market new systems. In addition, a court or government agency may take the position that our delivery of health information directly, including through licensed practitioners, or delivery of information by a third party site that a consumer accesses through our websites, exposes us to assertions of malpractice, other personal injury liability, or other liability for wrongful delivery/handling of healthcare services or erroneous health information. We anticipate that in the future we will maintain insurance to protect against claims associated with the use of our products as well as liability limitation language in our end-user license agreements, but there can be no assurance that our insurance coverage or contractual language would adequately cover any claim asserted against us. A successful claim brought against us in excess of or outside of our insurance coverage could have an adverse effect on our business, results of operations and financial condition. Even unsuccessful claims could result in our expenditure of funds for litigation and management time and resources.
There is significant uncertainty in the healthcare industry in which we operate, and we are subject to the possibility of changing government regulation, which may adversely impact our business, financial condition and results of operations.
The healthcare industry is subject to changing political, economic and regulatory influences that may affect the procurement processes and operation of healthcare facilities. During the past several years, the healthcare industry has been subject to an increase in governmental regulation of, among other things, reimbursement rates and certain capital expenditures. More recently, the healthcare industry has been subject to reductions in government funding of certain programs and the elimination of federal workers involved in the healthcare industry.
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Laws reforming the U.S. healthcare system and actions taken by the federal government may have an impact on our business. Various legislators have announced that they intend to examine proposals to reform certain aspects of the U.S. healthcare system and the Executive Branch has reduced or eliminated funding for many healthcare programs. Healthcare providers may react to these proposals, and the uncertainty surrounding such proposals, by curtailing or deferring investments, including those for our systems and related services. Cost-containment measures instituted by healthcare providers as a result of regulatory reform or otherwise could result in a reduction of the allocation of capital funds. Such a reduction could have an adverse effect on our ability to sell our systems and related services. On the other hand, changes in the regulatory environment have increased and may continue to increase the needs of healthcare organizations for cost-effective data management and thereby enhance the overall market for healthcare management information systems. We cannot predict what effect, if any, such proposals or healthcare reforms might have on our business, financial condition and results of operations.
We have taken steps to modify our products, services and internal practices as necessary to facilitate our compliance with applicable regulations, but there can be no assurance that we will be able to do so in a timely or complete manner. Achieving compliance with these regulations could be costly and distract management’s attention and divert other company resources, and any noncompliance by us could result in civil and criminal penalties.
Compliance with changing regulation of corporate governance and public disclosure will result in significant additional expenses.
Changing laws, regulations, and standards relating to corporate governance and public disclosure for public companies, including the Sarbanes-Oxley Act of 2002 and various rules and regulations adopted by the Securities and Exchange Commission (the “SEC”), are creating uncertainty for public companies. Our Company’s management will need to invest significant time and financial resources to comply with both existing and evolving requirements for public companies, which will lead, among other things, to significantly increased general and administrative expenses and a certain diversion of management time and attention from revenue generating activities to compliance activities.
We may be subject to false or fraudulent claim laws.
There are numerous federal and state laws that forbid submission of false information or the failure to disclose information in connection with submission and payment of physician claims for reimbursement. Any failure of our services to comply with these laws and regulations could result in substantial liability including, but not limited to, criminal liability, could adversely affect demand for our services and could force us to expend significant capital, research and development and other resources to address the failure. Errors by us or our systems with respect to entry, formatting, preparation or transmission of claim information may be determined or alleged to be in violation of these laws and regulations. Determination by a court or regulatory agency that our services violate these laws could subject us to civil or criminal penalties, invalidate all or portions of some of our client contracts, require us to change or terminate some portions of our business, require us to refund portions of our services fees, cause us to be disqualified from serving clients doing business with government payers and have an adverse effect on our business.
We are subject to the Stark Law, which may result in significant penalties.
Provisions of the Omnibus Budget Reconciliation Act of 1993 (42 U.S.C. § 1395nn) (the “Stark Law”) prohibit referrals by a physician of “designated health services” which are payable, in whole or in part, by Medicare or Medicaid, to an entity in which the physician or the physician’s immediate family member has an investment interest or other financial relationship, subject to several exceptions. Unlike the Fraud and Abuse Law, the Stark Law is a strict liability statute. Proof of intent to violate the Stark Law is not required. The Stark Law also prohibits billing for services rendered pursuant to a prohibited referral. Several states have enacted laws similar to the Stark Law. These state laws may cover all (not just Medicare and Medicaid) patients. Many federal healthcare reform proposals in the past few years have attempted to expand the Stark Law to cover all patients as well. As with the Fraud and Abuse Law, we consider the Stark Law in planning our products, marketing and other activities, and believe that our operations are in compliance with the Stark Law. If we violate the Stark Law, our financial results and operations could be adversely affected. Penalties for violations include denial of payment for the services, significant civil monetary penalties, and exclusion from the Medicare and Medicaid programs.
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If our products fail to comply with evolving government and industry standards and regulations, we may have difficulty selling our products.
We may be subject to additional federal and state statutes and regulations in connection with offering services and products via the Internet. On an increasingly frequent basis, federal and state legislators are proposing laws and regulations that apply to Internet commerce and communications. Areas being affected by these regulations include user privacy, pricing, content, taxation, copyright protection, distribution, and quality of products and services. To the extent that our products and services are subject to these laws and regulations, the sale of our products and services could be harmed.
Risks related to our Common Stock
There is not now, and there may never be, an active market for our common stock.
Our common stock is listed on the OTCQB level of the OTC Market under the symbol “USAQ,” but there is no active trading market for our common stock. There can be no assurance that an active trading market for our securities will develop, or that if one develops, that it will be sustained. The trading market for securities of companies listed on the OTC Market is substantially less liquid than the average trading market for companies listed on a national securities exchange. In addition, our ability to raise capital will be adversely affected by a listing on the OTC Market and the absence of an active trading market for our shares, as compared to a listing on a national securities exchange.
Our stock price is likely to be highly volatile because of several factors, including a limited public float.
The market price of our common stock has been volatile and is likely to be highly volatile in the future. You may not be able to resell shares of our common stock following periods of volatility because of the market’s adverse reaction to volatility.
Factors that could cause such volatility include, among other things:
| ● | actual or anticipated fluctuations in our operating results; | |
| ● | the limited number of securities analysts covering us and distributing research and recommendations about us; | |
| ● | the low public float for our common stock; |
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| ● | the low trading volume of our common stock; | |
| ● | announcements concerning our business or those of our competitors; | |
| ● | actual or perceived limitations on our ability to raise capital and to raise such capital on favorable terms; | |
| ● | conditions or trends in our industry; | |
| ● | litigation; | |
| ● | changes in market valuations of similar companies; | |
| ● | future sales of common stock; | |
| ● | departure of key personnel or failure to hire key personnel; and | |
| ● | general market conditions. |
Any of these factors could have a significant and adverse impact on the market price of our common stock. In addition, the stock market in general has at times experienced extreme volatility and rapid decline that has often been unrelated or disproportionate to the operating performance of particular companies. These broad market fluctuations may adversely affect the trading price of our common stock and/or warrants, regardless of our actual operating performance.
Our stock price may be adversely impacted by natural disasters (whether or not caused by climate change), unusually adverse weather conditions, pandemic outbreaks, terrorist acts, conflicts between nations and terrorist organizations, actions taken by governments such as the imposition of tariffs to impact economics, and the response of the governments of the countries affected by such occurrences.
Military or other conflicts such as those in Ukraine, the Middle East or elsewhere, natural disasters, unusually adverse weather conditions and pandemic outbreaks, and actions taken by governments such as the imposition of tariffs, may lead to increased volume and price volatility for publicly traded securities, or affect the operations or financial condition of companies, and lead to national, regional or international economic disruptions and economic uncertainty, any of which could adversely impact the price of our common stock.
Our common stock is subject to the “Penny Stock” Rules of the SEC, which makes transactions in our stock cumbersome and may reduce the value of an investment in our stock.
The SEC has adopted Rule 15g-9 which establishes the definition of a “penny stock,” for the purposes relevant to us, as any equity security that has a market price of less than $5.00 per share or with an exercise price of less than $5.00 per share, subject to certain exceptions. For any transaction involving a penny stock, unless exempt, the rules require: (a) that a broker or dealer approve a person’s account for transactions in penny stocks; and (b) the broker or dealer receive from the investor a written agreement to the transaction, setting forth the identity and quantity of the penny stock to be purchased.
In order to approve a person’s account for transactions in penny stocks, the broker or dealer must: (a) obtain financial information and investment experience and objectives of the person; and (b) make a reasonable determination that the transactions in penny stocks are suitable for that person and the person has sufficient knowledge and experience in financial matters to be capable of evaluating the risks of transactions in penny stocks.
The broker or dealer must also deliver, prior to any transaction in a penny stock, a disclosure schedule prescribed by the Commission relating to the penny stock market, which, in highlight form: (a) sets forth the basis on which the broker or dealer made the suitability determination; and (b) that the broker or dealer received a signed, written agreement from the investor prior to the transaction. Generally, brokers may be less willing to execute transactions in securities subject to the “penny stock” rules. This may make it more difficult for investors to dispose of our common shares and cause a decline in the market value of our stock.
Disclosure also has to be made about the risks of investing in penny stocks in both public offerings and in secondary trading and about the commissions payable to both the broker-dealer and the registered representative, current quotations for the securities and the rights and remedies available to an investor in cases of fraud in penny stock transactions. Finally, monthly statements have to be sent disclosing recent price information for the penny stock held in the account and information on the limited market in penny stocks.
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Shares eligible for future sale may adversely affect the market.
Substantially all of the outstanding shares of our common stock in addition to the shares issuable upon conversion of our outstanding convertible notes are freely tradable without restriction or registration under the Securities Act or otherwise eligible sale under Rule 144 promulgated under the Securities Act, subject to certain limitations. In general, pursuant to Rule 144, non-affiliate stockholders may sell freely after six months, subject only to the current public information requirement. Affiliates may sell after six months, subject to the Rule 144 volume, manner of sale (for equity securities), current public information, and notice requirements. All of the 11,281,527 shares of our common stock outstanding as of March 27, 2025, and the shares issuable upon conversion of our outstanding convertible notes and preferred stock may be sold in accordance with Rule 144 and only those shares held by Troy Grogan are subject to the volume limitation imposed by Rule 144 on sales by affiliates. Given the limited trading of our common stock, resale of even a small number of shares of our common stock pursuant to Rule 144 or an effective registration statement, may adversely affect the market price of our common stock.
Our sole director and officer controls a majority of the votes which may be cast at a meeting of our stockholders.
In addition to the common stock owned by our sole director and officer, he owns shares of our Series A and A-2 Preferred Stock which have the right to vote on all issues presented to our common stockholders. Taking into account the votes he is eligible to cast by virtue of the number of shares of our common stock and Series A and A-2 Preferred Stock held by our sole officer and director, he controls a majority of the votes which may be cast at a meeting of our stockholders, and therefore controls our operations and will have the ability to control all matters submitted to stockholders for approval. This stockholder thus has complete control over our management and affairs. Accordingly, his ownership may have the effect of impeding a merger, consolidation, takeover or other business consolidation, or discouraging a potential acquirer from making a tender offer for our common stock, which may further affect its liquidity.
Under our Certificate of Incorporation, our director has the authority, without stockholder approval, to issue preferred stock with terms that may not be beneficial to common stockholders and with the ability to adversely affect stockholder voting power and perpetuate the board’s control over our company.
Our director may authorize the issuance of preferred stock in one or more series with such limitations and restrictions as he may determine, in his sole discretion, with no further authorization by security holders required for the issuance of such shares. Our director may determine the specific terms of the preferred stock, including: designations; preferences; conversions rights; cumulative, relative; participating; and optional or other rights, including: voting rights; qualifications; limitations; or restrictions of the preferred stock. Our sole director has exercised this authority to authorize the Series A Preferred Stock which, taking into account the votes he is eligible to cast by virtue of the number of shares of our common stock and Series A Preferred Stock he holds, our sole director controls a majority of the votes which may be cast at a meeting of our stockholders, and therefore has the ability to control all matters submitted to stockholders for approval.
The issuance of preferred stock may adversely affect the voting power and other rights of the holders of common stock. Preferred stock may be issued quickly with terms calculated to discourage, make more difficult, delay or prevent a change in control of our company or make removal of management more difficult. As a result, the Board of Directors’ ability to issue preferred stock may discourage the potential hostile acquirer, possibly resulting in beneficial negotiations. Negotiating with an unfriendly acquirer may result in terms more favorable to us and our stockholders. Conversely, the issuance of preferred stock may adversely affect the market price of, and the voting and other rights of the holders of the common stock. We presently have no plans to issue any preferred stock.
We incur significant costs as a result of operating as a public company and our management will have to devote substantial time to public company compliance obligations.
The Sarbanes-Oxley Act of 2002, as well as rules subsequently implemented by the SEC and the national stock exchanges, have imposed various requirements on public companies, including requiring changes in corporate governance practices. Our management and other personnel will need to devote a substantial amount of time to these compliance requirements and any new requirements that the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 may impose on public companies. Moreover, these rules and regulations, along with compliance with accounting principles and regulatory interpretations of such principles, have increased and will continue to increase our legal, accounting and financial compliance costs and have made and will continue to make some activities more time- consuming and costly. For example, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced policy limits and coverage or incur substantial costs to maintain the same or similar coverage. These rules and regulations could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors or our board committees, or as executive officers. We will evaluate the need to hire additional accounting and financial staff with appropriate public company experience and technical accounting and financial knowledge. We estimate the additional costs to be incurred as a result of being a public company to be in excess of $150,000 annually.
Effective internal controls are necessary for us to provide reliable financial reports and to effectively prevent fraud. Management has assessed the effectiveness of our internal control over financial reporting as of December 31, 2024. Based on our assessment, we have concluded that our internal controls over financial reporting were not effective as of December 31, 2024, due to lack of an oversight committee and lack of segregation of duties. Management will consider the need to add personnel and implement improved review procedures.
Our system of internal control over financial reporting is not effective and we need to take remedial measures to improve our internal control over financial reporting. Remedial measures will likely require hiring additional personnel. We cannot assure our stockholders that the measures we will take to remediate areas in need of improvement will be successful or that we will implement and maintain adequate controls over our financial processes and reporting in the future. If we are unable to maintain appropriate internal financial reporting controls and procedures, it could cause us to fail to meet our reporting obligations, result in the restatement of our financial statements, harm our operating results, subject us to regulatory scrutiny and sanction, cause investors to lose confidence in our reported financial information and have a negative effect on the market price for shares of our common stock.
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Because we do not intend to pay any cash dividends on our common stock, our stockholders will not be able to receive a return on their shares unless they sell them.
We have not declared or paid any cash dividends on our common stock nor do we anticipate paying any in the foreseeable future. Furthermore, we expect to retain any future earnings to finance our operations and expansion. The payment of cash dividends in the future will be at the discretion of our Board of Directors and will depend upon our earning levels, capital requirements, any restrictive loan covenants and other factors the Board considers relevant. Unless we pay dividends, our stockholders will not be able to receive a return on their shares unless they sell them. We cannot assure you that you will be able to sell shares when you desire to do so.
We are a “Smaller Reporting Company” with reduced disclosure requirements which may make our common stock less attractive to investors.
We are a “smaller reporting company.” As a “smaller reporting company,” the disclosure we are required to provide in our SEC filings are less than it would be if we were not a “smaller reporting company.” Specifically, “smaller reporting companies” are able to provide simplified executive compensation disclosures in their filings; are exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act of 2002 requiring that independent registered public accounting firms provide an attestation report on the effectiveness of internal control over financial reporting and have certain other decreased disclosure obligations in their SEC filings, including, among other things, being permitted to provide two years of audited financial statements in annual reports rather than three years. Decreased disclosures in our SEC filings due to our status as a “smaller reporting company” may make it harder for investors to analyze the Company’s results of operations and financial prospects which may make our common stock less attractive, which may result in a less active trading market, higher volatility and a lower price for our common stock.
Limitations on director and officer liability and indemnification of our officers and directors by our articles of incorporation, as amended, and by-laws it may discourage stockholders from bringing suit against an officer or director.
Our articles of incorporation, as amended, and bylaws provide, with certain exceptions as permitted by Nevada law, that a director or officer shall not be personally liable to us or our stockholders for breach of fiduciary duty as a director or officer, unless the director or officer committed both a breach of fiduciary duty and such breach was accompanied by intentional misconduct, fraud or knowing violation of law. These provisions may discourage stockholders from bringing suit against a director or officer for breach of fiduciary duty and may reduce the likelihood of derivative litigation brought by stockholders on behalf of us against a director or officer.
We are responsible for the indemnification of our officers and directors.
Should our officers and/or directors require us to contribute to their defense in an action brought against them in their capacity as such, we may be required to spend significant amounts of our capital. Our articles of incorporation, as amended, and bylaws also provide for the indemnification of our directors, officers, employees, and agents, under certain circumstances, against attorney’s fees and other expenses incurred by them in any litigation to which they become a party arising from their association with or activities on behalf of us. In addition, we have entered into an indemnification agreement with our Chief Executive Officer. This indemnification policy could result in substantial expenditures, which we may be unable to recoup. If these expenditures are significant or involve issues which result in significant liability for our key personnel, we may be unable to continue operating as a going concern.
ITEM 1B. UNRESOLVED STAFF COMMENTS.
None.
ITEM 1C. CYBERSECURITY
Our Approach to Cybersecurity Risk Management
Our cybersecurity framework is built around a comprehensive strategy that includes ongoing risk assessment, threat detection, swift incident response, and continuous improvement of our cybersecurity defenses. Key elements of our program include:
| ● | Framework Adoption: Utilization of the CIS Critical Security Controls (CIS Controls) Cybersecurity Framework as a benchmark for evaluating the effectiveness of our cybersecurity measures. | |
| ● | Cybersecurity Assessments: Regular assessments of our cybersecurity through both internal evaluations and planned periodical third-party audits, ensuring adherence to the highest standards of security. | |
| ● | Training and Awareness: Mandatory cybersecurity training for all employees upon onboarding and through annual refreshers, fostering a culture of security awareness across the organization. | |
| ● | Incident Response and Preparedness: A well-defined incident response plan that enables us to quickly identify, contain, and mitigate the impact of cybersecurity incidents. | |
| ● | Third-Party Risk Management: | |
| ● | Investment in Security Infrastructure: Investment in cybersecurity technologies and infrastructure to stay ahead of emerging threats. |
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During the year ended December 31, 2024, the Company
has
Insurance and Risk Mitigation
We maintain cybersecurity insurance to mitigate the financial impact of potential incidents. However, we recognize that insurance is only one component of a multifaceted risk management strategy.
Incident Response and Risk Management at QHSLab, Inc.
Incident Assessment and Response Procedures
The process includes:
| ● | Immediate Assessment: Conducted by the incident response team to determine the incident’s nature, scope, and potential impact on QHSLab, Inc.’s operations and sensitive patient data. | |
| ● | Elevation Protocol: Incidents with significant potential impact are promptly escalated to senior IT security team members for further review. This ensures that high-level expertise is applied to complex or severe cybersecurity events. | |
| ● | Material Impact Analysis: Management assesses the potential for substantial harm to the organization, considering factors such as data integrity, patient privacy, and operational continuity. | |
| ● | Public Disclosure Considerations: In alignment with regulatory requirements and our commitment to transparency, management evaluates the necessity and timing for public disclosure, balancing patient privacy, legal obligations, and public interest. |
Commitment to Continuous Improvement
Recognizing the dynamic nature of cyber threats, particularly in the digital medicine sector, our incident response plan is subject to ongoing review and refinement. We will regularly update our procedures to incorporate any lessons learned from past incidents and emerging best practices in cybersecurity.
ITEM 3. LEGAL PROCEEDINGS.
We are currently not a party to any material legal or administrative proceedings and are not aware of any pending legal or administrative proceedings against us. We may from time to time become a party to various legal or administrative proceedings arising in the ordinary course of our business.
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PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.
Our common stock is subject to quotation on the OTCQB venture market under the symbol USAQ. The following table shows the high and low bid prices for our common stock during the fiscal years 2024 and 2023 as reported by the OTC Market. These prices reflect inter-dealer quotations without adjustments for retail markup, markdown or commission, and do not necessarily represent actual transactions.
| Price Range | ||||||||
| Period | High | Low | ||||||
| Year Ended December 31, 2024: | ||||||||
| First Quarter | $ | 0.18 | $ | 0.04 | ||||
| Second Quarter | $ | 0.35 | $ | 0.06 | ||||
| Third Quarter | $ | 0.32 | $ | 0.09 | ||||
| Fourth Quarter | $ | 0.44 | $ | 0.08 | ||||
| Year Ended December 31, 2023: | ||||||||
| First Quarter | $ | 0.398 | $ | 0.11 | ||||
| Second Quarter | $ | 0.247 | $ | 0.065 | ||||
| Third Quarter | $ | 0.198 | $ | 0.0315 | ||||
| Fourth Quarter | $ | 0.09 | $ | 0.016 | ||||
Holders
On March 28, 2025, there were approximately 651 holders of record of our common stock. The number of record holders does not include persons who held our common stock in nominee or “street name” accounts through brokers.
Dividend Policy. We have neither declared nor paid any cash dividends on either preferred or common stock. For the foreseeable future, we intend to retain any earnings to finance the development and expansion of our business and do not anticipate paying any cash dividends on our preferred or common stock. Any future determination to pay cash dividends will be at the discretion of the Board of Directors and will be dependent upon then existing conditions, including our financial condition, results of operations, capital requirements, contractual restrictions, business prospects, and other factors that the Board of Directors considers relevant. To the extent we issue preferred shares that provide for a periodic dividend, we will seek to pay the dividend in securities in lieu of cash.
Securities Authorized for Issuance Under Equity Compensation Plans
In 2020 we adopted an Equity Incentive Plan which authorizes grants with respect to up to 2,000,000 shares of our common stock. No grants have been made pursuant to the plan.
Recent Sales of Unregistered Equity Securities
All sales of unregistered securities made by us during 2024 were previously reported.
Purchases of Our Equity Securities
No repurchases of our common stock were made by us during the fiscal year ended December 31, 2024.
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ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS AND OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The following discussion and analysis of our financial condition and results of operations contains forward-looking statements and involves numerous risks and uncertainties, including, but not limited to, those described in the “Risk Factors” section of this Report. Actual results may differ materially from those contained in any forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential” or “continue,” the negative of such terms or other comparable terminology. These statements are only predictions. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Moreover, neither we, nor any other person, assume responsibility for the accuracy and completeness of the forward-looking statements. We are under no obligation to update any of the forward-looking statements after the filing of this Report to conform such statements to actual results or to changes in our expectations.
The following discussion and analysis of financial condition and results of operations relates to the operations and financial condition reported in the consolidated financial statements of QHSLab, Inc. and its subsidiaries for the years ended December 31, 2024 and 2023 and should be read in conjunction with such consolidated financial statements and related notes included in this report.
Overview
We are a medical device technology and software as a service (SaaS) company focused on enabling primary care physicians (PCPs) and other healthcare providers to increase their revenues by providing them with relevant, value-based tools to evaluate and treat chronic disease as well as provide preventive care through reimbursable procedures. In some cases, the products we provide our physician clients will enable them to diagnose and treat patients with chronic diseases which they historically have referred to specialists, allowing them to increase their practice revenue. As part of our mission, we are providing PCPs and other healthcare providers with the software, training and devices necessary to allow them to treat their patients using value-based healthcare, informatics and personalized medicine. Our digital healthcare, clinical decision support and point of care solutions also support non face to face remote patient and therapeutic monitoring, to address chronic care and preventive medicine and are reimbursable to the medical practice.
Increasingly, regulators and insurance companies have come to recognize what health care technologists have been saying for nearly 20 years, which is that most chronic conditions are better managed with more frequent and short encounters often without a physician’s direct participation, rather than infrequent visits. More health insurers have realized that AI enabled digital medicine technologies such as those provided through QHSLab can provide the necessary encounters to foster patient compliance in between face to face visits to a physician.
In November 2020, we began shipping AllergiEnd® diagnostic related products and immunotherapy treatments to PCPs in response to their requests based upon courses of treatment recommended for their patients building on the capabilities of QHSLab, our primary SaaS tool.
Based on the success of PCPs and other healthcare providers using our QHSLab allergy diagnostics and quality of life enhancing digital medicine tools combined with the products acquired from MedScience, we intend to increase our revenues by charging physicians various service, assessment, program and subscription fees for the use of QHSLab and soliciting additional healthcare providers to increase their revenues by using our proven revenue generating QHSLab and AllergiEnd® line of products. We also plan to introduce additional point of care diagnostics and treatments, and digital medicine programs that providers can use and prescribe in their practices. In all cases, providers will be paid under existing government and private insurance programs, based upon analyses conducted utilizing QHSLab and treatments provided as a result of such analyses.
Our ability to operate profitably is determined by our ability to generate revenues from the licensing of our QHSLab software and the sale of diagnostic related products and treatment protocols and the provision of services through our QHSLab system. Currently, we are generating revenues from the sale of AllergiEnd® diagnostic related products and immunotherapy treatments. Our ability to generate a profit from these sales is determined by our ability to increase the number of physicians using these products. We will continue to upgrade QHSLab in an effort to increase the number of products sold based upon the services it can provide and for which we are able to charge a fee for its use.
We operate as a single operating segment and single reportable segment. Operating segments are defined as components of a business that can earn revenue and incur expenses and for which discrete financial information is evaluated regularly by the chief operating decision maker (CODM) in deciding how to allocate resources and assess performance. Our CODM, the Chief Executive Officer, allocates resources and assesses performance based upon consolidated financial information due to the interconnected relationship of our products to the same customers, therefore manages our business as a single operating segment.
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Operational Highlights
Results of Operations during the year ended December 31, 2024 as compared to the year ended December 31, 2023
Revenues
During the fourth quarter of 2020 we began to sell the AllergiEnd® Products, consisting of AllergiEnd® Allergy Diagnostics and Allergen Immunotherapy treatments, to physicians. During the second quarter of 2022, we began to enter into SaaS subscription agreements to provide physicians with access to our proprietary internally-developed QHSLab platform software that provides clinical decision support and patient monitoring for numerous chronic conditions seen in primary care settings including allergy, asthma, anxiety, depression, chronic pain, and sleep disorders for example. During the fourth quarter of 2022, we began entering into Integrated Service Program (ISP) agreements to provide physicians’ offices with agreed-upon clinical decision support, digital health assessments, administrative workflow, and reimbursement support services utilizing our QHSLab platform.
For the year ended December 31, 2024, we generated revenues of $2,131,926 compared to $1,408,995 of revenues in 2023. Revenues in 2024 were primarily driven by sales of Allergy Diagnostic Kits of $832,987 and ISP services of $643,211. The increase in revenues in the year ended 2024 were attributed to a 138% increase in revenues generated from ISP services to $643,211 compared to $270,022 for the year ended December 31, 2023; a 25% increase in sales of Allergy Diagnostic Kits to $832,987 compared to $666,600 for the year ended December 31, 2023 and the inclusion of revenues as a result of the achievement of the initial performance obligations associated with our clinical study.
Our revenues consisted of the following:
| For the Years Ended | ||||||||
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Allergy Diagnostic Kit Sales | $ | 832,987 | $ | 666,600 | ||||
| Integrated Service Program Revenue | 643,211 | 270,022 | ||||||
| Immunotherapy Treatment Sales | 409,319 | 363,184 | ||||||
| Clinical Study Revenue | 133,650 | - | ||||||
| Subscription Revenue | 54,523 | 72,200 | ||||||
| Shipping and handling | 35,892 | 32,339 | ||||||
| Training & Other Revenue | 22,344 | 4,650 | ||||||
| Total revenue | $ | 2,131,926 | $ | 1,408,995 | ||||
Cost of Revenues and Gross Profit
Cost of revenues consists of the cost of the AllergiEnd® test kits and allergen immunotherapy pharmacy prepared treatment sets, shipping costs to our customers as well as administrative services and labor expenses directly related to ISP sales and the amortization of our capitalized software.
For the years ended December 31, 2024 and 2023, cost of revenues was $774,036 and $615,388, respectively.
The Company generated a gross profit of $1,357,890, for the year ended December 31, 2024 and $793,607, in 2023. Gross margin increased from 56.3% during the year ended December 31, 2023 to 63.7% during the year ended December 31, 2024. The increase in gross margin for the year ended December 31, 2024 was attributable to a combination of changes in the product mix including the growth of ISP revenue and improved cost structure since the acquisition of intangible assets from MedScience and synergies across our core product lines as well as the recognition of revenue as a result of the achievement of the initial research performance obligations associated with the clinical study which utilizes costs already included in cost of goods sold.
As we continue to introduce new products at an early stage in our development cycle, the gross margins may vary significantly between periods, due, among other things, to differences among our customers and products sold, customer negotiating strengths, and product mix.
Sales and Marketing
Sales and marketing expenses consist primarily of costs associated with selling and marketing our products to PCPs, principally ongoing sales efforts to recruit new PCPs and maintain our relationships with PCPs already using our software and products. These expenses include employee compensation and costs of consultants.
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For the year ended December 31, 2024, sales and marketing expenses totaled $509,065, an increase of $20,528, compared to $488,537 for the year ended December 31, 2023.
The increases in sales and marketing expenses for the year ended December 31, 2024 compared to 2023 relate primarily to increases in payroll-related expenses as we are investing in more sales and marketing activities to support our increasing ISP revenue. We expect our sales and marketing expenses to increase as we seek to build our customer base and launch additional products. Nevertheless, if we are successful in onboarding a sufficient number of PCPs and maintaining our relationships with these PCPs once they begin to distribute our products, selling and marketing expenses could decrease as a percentage of revenues, though we may increase our marketing efforts as funds become available.
General and Administrative
General and administrative expenses consist primarily of costs associated with operating a business including accounting, legal and management consulting fees.
For the year ended December 31, 2024, general and administrative expenses totaled $276,496, an increase of $17,388, compared to $259,108 for the year ended December 31, 2023.
The increase in general and administrative expenses for the year ended December 31, 2024, as compared to 2023, is primarily due to increases in sales processing, cloud-related hosting and legal fees partially offset by continued decreases in management consulting services.
Research and Development
Research and development (R&D) expenses include expenses incurred in connection with the research and development of our medical device technology solutions, including software development. R&D costs are expensed as they are incurred.
For the year ended December 31, 2024, R&D expenses totaled $294,479, which is an increase of $80,471, compared to $214,008 for the year ended December 31, 2023.
The increases in R&D expenses for the year ended December 31, 2024, as compared to 2023, were driven by increases in software development expenses as we continue to expand the commercialization of our QHSLab platform software and R&D consulting expenses including the appointment of a medical and scientific affairs liaison during the second quarter of 2024. We expect that our R&D expenses will continue to increase as we invest in and expand our operations and further develop new products and services as part of our growth strategy.
Other Income and Expense
For the year ended December 31, 2024, interest expense increased by $234,561 to $465,055 from $230,494 for the year ended December 31, 2023.
The increase is driven by default interest expense of $328,427 related to the Mercer Fund $806,000 Note and $440,000 Note partially offset by decreases due to the timing of the amortization of debt issuance costs including legal fees and warrants issued in connection with certain of our convertible notes payable. Interest expense during the year ended 2024 included interest on the outstanding debt balance as all debt issuance costs including legal fees and warrants issued in connection with the second Mercer note in July 2022 (Second OID Note) and the first Mercer note issued in August 2021 (First OID Note) were fully amortized by the end of 2023.
There was $78 of other income for the year ended December 31, 2024 compared to $2,290 for the comparable period in 2023 which was related to the redemption of awards on a credit card.
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Liquidity and Capital Resources
Liquidity is a measure of a company’s ability to generate funds to support its current and future operations, satisfy its obligations, and otherwise operate on an ongoing basis. On December 31, 2024, we had current assets totaling $420,827, including $157,168 of cash, $196,089 of accounts receivable, $41,779 of inventory, and $25,791 related to prepaid expenses and other current assets. At such date we had total current liabilities of $2,407,308 consisting of $340,962 in accounts payable, $343,945 in other current liabilities and $1,722,401 representing the current portions of outstanding loans and convertible notes. There were no balances classified as long-term liabilities on our consolidated balance sheets.
On December 31, 2023, we had current assets totaling $156,132, including $51,582 of cash, $71,382 of accounts receivable, $25,181 of inventory, and $7,987 related to prepaid expenses and other current assets. At such date we had total current liabilities of $2,057,049 consisting of $78,907 in accounts payable, $196,590 in other current liabilities and $1,781,552 representing the current portions of outstanding loans and convertible notes. There were no long-term liabilities on our consolidated balance sheets as the entirety of our loans payable are included in current liabilities.
We generated cash flows of $142,437 from operations during the year ended December 31, 2024, we used cash of $159,627 in operations during the same period ending December 31, 2023. The generation rather than use of cash was driven by an increase in revenue and improved gross margins during the year ended December 31, 2024 compared to the same period ended December 31, 2023.
During the third quarter of 2021, we issued a promissory note of $750,000 (the Acquisition Note) in connection with our acquisition of assets related to our AllergiEnd® products and an Original Issue Discount Secured Convertible Promissory Note in the principal amount of $806,000 (the First OID Note) along with warrants to purchase 930,000 shares of our common stock (the Warrants) for aggregate consideration of $750,000. In July 2022, to supplement our cash on hand, we issued to the holder of the First OID Note an Original Issue Discount Secured Convertible Promissory Note (the Second OID Note) in the principal amount of $440,000 and warrants to purchase 550,000 shares of our common stock for aggregate consideration of $400,000.
All amounts outstanding under the First OID Note and Second OID Note were payable on August 10, 2022, and July 22, 2023, respectively, the OID Notes remain unpaid and are secured by a lien on substantially all of our assets.
The remaining principal and interest accrued on the Acquisition Note was $433,334 as of December 31, 2024, and we are in default under this Note. We last received a notice of forbearance from the holder of the Acquisition Note on March 20, 2025, in which it reserved all of its rights. We also are currently in default of our obligations under the First OID Note and the Second OID Note. We last received a notice of forbearance from the manager of Mercer Street Global Opportunity Fund, LLC, the holder of the First and Second OID Notes, on February 19, 2024, in which it reserved all rights it might have as a result of our defaults under the First OID Note, the Second OID Note and the related documents between us and the Fund. Amounts accrued as interest under the Acquisition Note do not include interest and penalties which would be payable if the holder of such Note elects to exercise its rights under the default provisions of the Note. There is no guarantee that the manager of Mercer Street Global Opportunity Fund, LLC and the holder of the Acquisition Note will continue to forbear from exercising such rights as they may have to collect amounts due, including seeking to foreclose upon such liens they may have on our assets.
On February 20, 2025, the Company received a Notice of Default from Mercer Street Global Opportunity Fund, LLC (the Lender) in connection with the First OID Note and the Second OID Note. Under the terms of the Notes, a failure to pay the principal and interest when due constitutes an Event of Default. The Company has accrued default interest of 18% as of December 31, 2024 for these notes. See Note 7 Convertible Notes Payable for additional information regarding these notes.
Plan of Operation and Funding
The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. We had an accumulated deficit of $4,331,350 at December 31, 2024, generated net losses of $259,239 and $468,362 for the years ended December 31, 2024 and 2023, respectively, and generated cash from operations of $142,437 in the year ended December 31, 2024, and used $159,627 of cash in operations in the year ended December 31, 2023. We are currently in default of our obligations under our OID Notes and the Acquisition Note. These factors, among others, raise substantial doubt about our ability to continue as a going concern for a reasonable period of time. Our continuation as a going concern is dependent upon our ability to obtain necessary equity or debt financing and ultimately from generating revenues and positive cash flow to continue operations and, in the interim, to convince the holders of our notes to forbear from exercising any rights they might have as a result of our defaults. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.
Our working capital requirements are expected to increase in line with the growth of our business. We will remain highly leveraged as we seek to expand our business. Existing working capital and anticipated cash flows are expected to be adequate to fund our operations over the next twelve months. If necessary, we would seek to supplement such amounts through the issuance of debt or equity.
In addition to using our cash to satisfy our working capital needs, we have begun to make payments on our outstanding indebtedness to avoid continued growth in the amount of accrued interest and penalties, and to retain the support of our lenders. While the holders of our First and Second OID Notes and the Acquisition Note have agreed to forbear from exercising their rights as a result of our defaults at this time, there is no guarantee they will continue to do so. If they elect to exercise their rights, the amount of accrued interest and penalties owed under the agreements will substantially increase. Further, should they demand immediate payment of all amounts currently due and, in the case of Mercer, exercise its rights under its Security Agreements, it would have a material adverse effect on our business and jeopardize our ability to continue operations. Any future effort to restructure existing indebtedness through agreements with our current lenders to allow us to increase the amount we can devote to expanding our operations will require the consent of our current lenders and likely would require the issuance of additional debt or equity securities. Should we seek to raise additional capital to satisfy our lenders, there is no assurance sufficient amounts will be available.
While we are focused on our business, we intend to continually explore our options to raise additional capital or, when available, borrow additional funds on terms which we believe are favorable to us. Additional issuances of equity or convertible debt securities will result in dilution to our current shareholders, could require the issuance of equity securities at prices we believe are below our true value and could cause the price of our common stock to decrease. Further, such securities might have rights, preferences or privileges senior to our common stock. Additional borrowings could require that we grant the lenders a security interest or other rights that impede our ability to operate as we deem best for our shareholders. Further, any default under a loan agreement could result in an action which could force us to seek bankruptcy protection. Additional financing may not be available upon acceptable terms, or at all. If adequate funds are not available or are not available on acceptable terms, we may not be able to maintain or expand our existing operations, take advantage of prospective new business endeavors or opportunities, which could significantly and materially restrict our business and adversely impact our financial results.
Our ability to obtain funds through the issuance of debt or equity is dependent upon the state of the financial markets at such time as we may seek to raise funds. The state of the capital markets may be adversely impacted by various risks and uncertainties, including, but not limited to future and current impacts of global events such as wars in the Ukraine and Israel, increases in inflation and other risks detailed in the risk factors sections detailed in this 2024 Annual Report on Form 10-K.
Critical Accounting Policies
Our significant accounting policies are described in the notes to our consolidated financial statements included elsewhere in this annual report.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
See “Index to Consolidated Financial Statements” which appears on page F-1 of this Annual Report on Form 10-K.
| 26 |
ITEM 9A. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls and Procedures
As of December 31, 2024, the Company’s chief executive officer/chief financial officer conducted an evaluation regarding the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e)) under the Exchange Act. Based upon the evaluation of these controls and procedures, our chief executive officer/chief financial officer concluded that our disclosure controls and procedures were not effective as of the end of fiscal year 2024.
Management’s Annual Report on Internal Control Over Financial Reporting
Management is responsible for establishing and maintaining adequate internal controls over financial reporting and for the assessment of the effectiveness of those internal controls. As defined by the SEC, internal control over financial reporting is a process designed by our principal executive officer/principal financial officer to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the financial statements in accordance with U.S. generally accepted accounting principles.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Management has assessed the effectiveness of our internal control over financial reporting as of December 31, 2024. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework. Based on our assessment and those criteria, we have concluded that our internal control over financial reporting were not effective as of December 31, 2024, due to lack of an oversight committee and lack of segregation of duties. Management will consider the need to add personnel and implement improved review procedures as we begin to generate positive cash flow.
This annual report does not include an attestation report of the Company’s registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the Company’s registered public accounting firm pursuant to temporary rules of the Securities and Exchange Commission that permit the Company to provide only Management’s report in this annual report.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting or in other factors identified in connection with the evaluation required by paragraph (d) of Exchange Act Rules 13a-15 or 15d-15 that occurred during the year ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitations of the Effectiveness of Controls
Management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all error and fraud. A control system, no matter how well designed and operated, is based upon certain assumptions and can provide only reasonable, not absolute, assurance that its objectives will be met. Further, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, within the Company have been detected.
ITEM 9B. OTHER INFORMATION.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.
Not Applicable.
| 27 |
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
| Name | Age | Title | ||
| Troy Grogan | 47 | CEO, CFO and Chairman |
Troy Grogan has been our Chairman and CEO since June 2016. Mr. Grogan has a background in health promotion, healthcare technology, and medical education – originally in Australia. He was previously appointed by the Minister of Health to one of Australia’s largest health systems in Sydney and served on numerous committees for over ten years. Mr. Grogan has also been involved with a U.S. based medical device manufacturer, founded a workplace wellness company, and co-developed numerous University-affiliated Continuing Medical Education programs for physicians and healthcare providers. Mr. Grogan attended Newcastle University, studying biological sciences and the University of New England where he studied Corporate Governance.
ITEM 11. EXECUTIVE COMPENSATION.
Officer’s and Director’s Compensation
Mr. Grogan, our CEO and only executive officer, does not have an employment agreement and is not entitled to receive any compensation for services rendered prior to December 31, 2024. Given the efforts being made by Mr. Grogan on behalf of the Company and the continued growth in our business, the Company intends beginning in 2025 to accrue compensation for his services and, subject to cash availability, to pay such amounts as may accrue in his favor.
Equity Awards
We did not grant Mr. Grogan any equity awards or stock options during the year ended December 31, 2024.
Outstanding Equity Awards at Fiscal Year-End
There were no equity awards outstanding as of the year ended December 31, 2024, nor were there any securities authorized for issuance under equity compensation plans.
| 28 |
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREHOLDER MATTERS.
Security Ownership
The following table sets forth information concerning beneficial ownership of our common stock as of March 28, 2025 by (i) any person or group with more than 5% of our common stock, (ii) our sole director, (iii) and our sole officer and director as a “group.”
Except as otherwise indicated, we believe, that each party named in the table below has sole investment and voting power with respect to his shares, subject to community property laws, where applicable. As of March 28, 2025, we had outstanding 11,281,527 shares of common stock and 1,080,092 shares of Series A Preferred Stock and 2,644,424 shares of Series A-2 Preferred Stock. Shares of Series A Preferred Stock are convertible into shares of our common stock at a conversion price of $0.05 per share, subject to certain anti-dilution adjustments. Shares of Series A-2 Preferred Stock are convertible into shares of our common stock at a conversion price of $0.16 per share, subject to certain anti-dilution adjustments. In addition, shares of common stock issuable upon exercise of options, warrants and other convertible securities anticipated to be exercisable or convertible at or within sixty days of March 28, 2025, are deemed outstanding for the purpose of computing the percentage ownership of the person holding those securities, and the group as a whole, but are not deemed outstanding for computing the percentage ownership of any other person. The address of Mr. Grogan is c/o of our company at 901 Northpoint Parkway, Suite 302, West Palm Beach, Florida 33407.
| Name of Shareholder | Amount and Nature of Beneficial Ownership | Percent of Common Stock | ||||||
| Directors and Executive Officers: | ||||||||
| Troy Grogan1 | 11,888,048 | (1) | 52.98 | % | ||||
| All directors and executive officers as a group (1 person) | 11,888,048 | (1) | 52.98 | % | ||||
| Owners of more than 5% of our outstanding shares: | ||||||||
| Mercer Street Global Opportunity Fund, LLC | 7,659,694 | (2) | 46.18 | % | ||||
| (1) | Includes 3,843,164 shares of common stock, 5,400,460 shares of common stock that may be acquired upon conversion of shares of Series A Preferred Stock and 2,644,424 shares of common stock that may be acquired upon conversion of Series A-2 Convertible Preferred Shares, without giving effect to dividends accrued but not paid. | |
| (2) | Jonathan Juchno is the managing partner of Mercer Street Global Opportunity Fund, LLC, and its principal business address is 1111 Brickell Ave, Ste 2920, Miami, FL 33131. Includes 2,310,000 shares of common stock issuable upon conversion of the Second OID Note, including interest, at a conversion price of $0.20 per share, 3,371,500 shares issuable upon conversion of the First OID Note; and 550,000 shares issuable upon exercise of the 2022 Warrants, without giving effect to the blocker described in the next sentence. The Notes and Warrants held by Mercer are subject to beneficial ownership limitations such that the Notes and Warrants may not be converted or exercised, respectively, if it would result in the holder exceeding the beneficial ownership limitation. The beneficial ownership limitation is initially 9.99% and in the case of the Notes may be increased, upon 61 days’ notice to the Company, or in the case of the Notes and Warrants, decreased immediately upon written notice to the Company. The number of shares attributed to Mercer is estimated by the Company based upon its understanding of the terms of the OID Notes and assumes that if Mercer seeks to convert the Notes, it seeks the maximum number of shares issuable upon conversion after giving effect to the existing Events of Default. |
| 29 |
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE.
Our principal executive offices are located at 901 Northpoint Parkway Suite 302, West Palm Beach, FL 33407. We are provided our office space at no cost by an entity related to Troy Grogan.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES.
Principal Accounting Fees
On June 4, 2024, the Company advised Accell Audit and Compliance, P.A., (“Accell”) that the Company’s Board of Directors had determined to dismiss Accell as the Company’s independent auditors effective June 4, 2024. Accell issued the auditor’s report on the Company’s financial statements for the years ended December 31, 2021, 2022 and 2023.
Effective June 4, 2024, the Board of Directors of the Registrant approved the appointment of Astra Audit & Advisory LLC as its new independent registered auditor to audit the Registrant’s financial statements for its year ended December 31, 2024.
Principal Accounting Fees
The following table presents the fees for professional audit services rendered by Astra Audit & Advisory LLC and Accell Audit and Compliance, P.A. for the audit of the Registrant’s annual financial statements and review of the quarterly reports on Form 10-Q and Annual Reports on Form 10-K for the years ended December 31, 2024 and 2023.
| Year Ended | Year Ended | |||||||
| December 31, 2024 | December 31, 2023 | |||||||
| Audit fees | $ | 66,000 | $ | 64,500 | ||||
Section 16(a) Compliance
Section 16(a) of the Securities and Exchange Act of 1934 requires the Registrant’s directors and executive officers, and persons who own beneficially more than ten percent (10%) of the Registrant’s Common Stock, to file reports of ownership and changes of ownership with the Securities and Exchange Commission. Copies of all filed reports are required to be furnished to the Registrant pursuant to Section 16(a). Based solely on the reports received by the Registrant and on written representations from reporting persons, the Registrant believes that its officer and director has not filed all reports required under Section 16(a). All of the information that would be provided by such reports is disclosed in the Company’s periodic reports filed on EDGAR and the Company’s sole director has made no sales of its shares that would be required to be disclosed under Section 16(a).
| 30 |
PART IV
ITEM 15. EXHIBITS, AND FINANCIAL STATEMENT SCHEDULES.
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document | |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
ITEM 16. FORM 10-K SUMMARY
None.
| 31 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the date indicated.
| QHSLab, Inc. | ||
| By: | /s/ Troy Grogan | |
| Troy Grogan | ||
|
Chief Executive Officer, Chief Financial Officer And Director |
||
Date: March 28, 2025
| 32 |
QHSLAB, INC. AND SUBSIDIARIES
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
| F-1 |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Board of Directors and
Stockholders of QHSLab, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of QHSLab, Inc. (the Company) as of December 31, 2024 and 2023, and the related consolidated statements of operations, stockholders’ deficit, and cash flows for each of the years in the two-year period ended December 31, 2024, and the related notes (collectively referred to as the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.
Substantial Doubt about the Company’s Ability to Continue as a Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has only recently operated profitably, is highly leveraged and has only recently begun to generate cash from operations. These conditions raise substantial doubt about its ability to continue as a going concern. Management’s plans regarding these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Impairment of Intangibles
As described in Note 3 to the Company’s financial statements, the Company evaluates intangible assets with finite lives for impairment when events or changes in circumstances in an impairment may exist and indefinite lives for impairment at least annually or when events or changes in circumstances indicates that an impairment may exist.
We identified the Company’s application of the accounting for impairment of intangibles as a critical audit matter. The principal considerations for our determination of this critical audit matter related to the high degree of subjectivity in the Company’s judgments in determining the qualitative and quantitative factors. Auditing these judgments and assumptions by the Company involves auditor judgment due to the nature and extent of audit evidence and effort required to address these matters.
The primary procedures we performed to address this critical audit matter included the following:
| ● | We obtained the impairment analysis, reviewed, and determined if the Company assessed the intangible assets at the appropriate level. | |
| ● | We reviewed the qualitative factors analyzed by the Company and performed an assessment of any possible indicators of impairment. | |
| ● | We obtained the computation of the sum of undiscounted cash flows expected to result from the asset group and reviewed the analysis as to whether the carrying amount of the asset group is recoverable. |
| ○ | We performed an analysis, including comparing the significant assumptions used by management to historical operating results, comparing actual results to the amounts shown in the computation, as well as computing expected future results based on the actual results. |
We have served as the Company’s auditor since 2024.
March 28, 2025
3702 W. Spruce Street #1430 ● Tampa, Florida 33607 ● +1.813.441.9707
| F-2 |
QHSLab, Inc.
Consolidated Balance Sheets
As of December 31, 2024 and 2023
| December 31, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Accounts receivable, net | ||||||||
| Inventory | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Non-current assets: | ||||||||
| Capitalized software development costs, net | ||||||||
| Intangible assets, net | ||||||||
| Total assets | $ | $ | ||||||
| Liabilities and Stockholders’ Deficit | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Other current liabilities | ||||||||
| Loans payable | ||||||||
| Convertible notes payable | ||||||||
| Total current liabilities | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 13) | ||||||||
| Stockholders’ Deficit: | ||||||||
| Preferred stock, shares authorized | ||||||||
| Preferred stock Series A, $ par value; shares issued and outstanding | ||||||||
| Preferred stock Series A-2, $ par value; shares issued and outstanding | ||||||||
| Common stock, shares authorized, $ par value; and shares issued and outstanding at December 31, 2024 and 2023, respectively | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ deficit | ( | ) | ( | ) | ||||
| Total liabilities and stockholders’ deficit | $ | $ | ||||||
See accompanying notes to consolidated financial statements.
| F-3 |
QHSLab, Inc.
Consolidated Statements of Operations
For the Years Ended December 31, 2024 and 2023
| Year Ended | Year Ended | |||||||
| December 31, 2024 | December 31, 2023 | |||||||
| Revenue | $ | $ | ||||||
| Cost of revenue | ||||||||
| Gross profit | ||||||||
| Operating Expenses: | ||||||||
| Sales and marketing | ||||||||
| General and administrative | ||||||||
| Research and development | ||||||||
| Amortization | ||||||||
| Total Operating Expenses | ||||||||
| Net operating income (loss) | ( | ) | ||||||
| Other income and (expense) | ||||||||
| Interest expense | ( | ) | ( | ) | ||||
| Other income | ||||||||
| Loss before income taxes | ( | ) | ( | ) | ||||
| Provision on income taxes | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Basic net loss per share | $ | ( | ) | $ | ( | ) | ||
| Diluted net loss per share | $ | ( | ) | $ | ( | ) | ||
| Weighted average shares outstanding: | ||||||||
| Basic | ||||||||
| Diluted | ||||||||
See accompanying notes to consolidated financial statements.
| F-4 |
QHSLab, Inc.
Consolidated Statements of Stockholders’ Deficit
For the Years Ended December 31, 2024 and 2023
Preferred – Stock- Series A | Preferred Stock - Series A-2 | Common Stock | Additional Paid-In | Accumulated | Total Stockholders’ Equity | |||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Capital | Deficit | (Deficit) | ||||||||||||||||||||||||||||
| December 31, 2022 Balance at | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||||||
| Stock-based compensation expense | - | - | - | |||||||||||||||||||||||||||||||||
| Conversion of notes payable | - | - | ||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||
| Balance at December 31, 2023 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||||||
| Conversion of notes payable | - | - | ||||||||||||||||||||||||||||||||||
| Common stock dividend on A-2 Preferred Shares | - | - | ( | ) | ||||||||||||||||||||||||||||||||
| Shares issued for services | - | - | ||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||||||
See accompanying notes to consolidated financial statements.
| F-5 |
QHSLab, Inc.
Consolidated Statements of Cash Flows
For the Years Ended December 31, 2024 and 2023
| Year Ended | Year Ended | |||||||
| December 31, 2024 | December 31, 2023 | |||||||
| Operating activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash from operating activities: | ||||||||
| Allowance for doubtful accounts | ||||||||
| Amortization | ||||||||
| Amortization of debt and warrant issuance costs | ||||||||
| Stock-based compensation | ||||||||
| Shares issued for services | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | ( | ) | ( | ) | ||||
| Inventory | ( | ) | ||||||
| Prepaid expenses and other current assets | ( | ) | ( | ) | ||||
| Accounts payable | ( | ) | ||||||
| Other current liabilities | ||||||||
| Cash flows from operating activities | ( | ) | ||||||
| Financing activities: | ||||||||
| Proceeds from related-party borrowings | ||||||||
| Proceeds of loan borrowings | ||||||||
| Repayments of loan borrowings | ( | ) | ( | ) | ||||
| Cash flows from financing activities | ( | ) | ||||||
| Change in cash | ( | ) | ||||||
| Cash and cash equivalents - beginning of year | ||||||||
| Cash and cash equivalents - end of period | $ | $ | ||||||
| Supplemental disclosures of cash flow activity: | ||||||||
| Cash paid for interest | $ | $ | ||||||
| Cash paid for taxes | $ | $ | ||||||
| Supplemental noncash investing and financing activity: | ||||||||
| Debt converted to shares of common stock | $ | $ | ||||||
| Common stock dividends on A-2 preferred shares | $ | $ | ||||||
See accompanying notes to consolidated financial statements.
| F-6 |
QHSLab, Inc.
Notes to Consolidated Financial Statements
December 31, 2024 and 2023
Note 1. The Company
QHSLab, Inc. (the “Company” or the “Registrant”) was incorporated in Delaware on September 1, 1983. In 2019, the Company became engaged in value-based healthcare, informatics and algorithmic personalized medicine including digital therapeutics, behavior based remote patient monitoring, chronic care and preventive medicine. On September 23, 2021, the Company changed its state of incorporation from Delaware to Nevada. On April 19, 2022, the Company changed its name to QHSLab, Inc.
The Company is a medical device technology and software-as-a-service (“SaaS”) company focused on enabling primary care physicians (“PCP’s”) to increase their revenues by providing them with relevant, value-based tools to evaluate and treat chronic disease as well as provide preventive care through reimbursable procedures.
Note 2. Going Concern
The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. The Company has only recently operated profitably, is highly leveraged and has only recently begun to generate cash from operations. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The continuation of the Company’s business is dependent upon its ability to achieve increased positive cash flows and continual profitability and, pending such achievement, future issuances of equity or other financings to fund ongoing operations. However, access to such funding may not be available on commercially reasonable terms, if at all. These consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
Note 3. Basis of Presentation
The consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). In the opinion of management, the accompanying audited consolidated financial statements include all adjustments, consisting of only normal recurring accruals, necessary for a fair statement of financial position, results of operations, and cash flows.
Segment Information
The Company operates as a single operating segment and single reportable segment. Operating segments are defined as components of a business that can earn revenue and incur expenses and for which discrete financial information is evaluated regularly by the chief operating decision maker (“CODM”) in deciding how to allocate resources and assess performance. The Company’s CODM, the Chief Executive Officer, allocates resources and assesses performance based upon consolidated financial information due to the interconnected relationship of the Company’s products to the same customers, therefore manages its business as a single operating segment. See Note 13 - Segment Information for additional information.
Accounting Policies
Use of Estimates: The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from the estimates.
| F-7 |
Principles of Consolidation: The consolidated financial statements include the accounts of QHSLab, Inc. and its wholly owned subsidiaries USAQ Corporation, Inc. and Medical Practice Income, Inc. All significant inter-company balances and transactions have been eliminated.
Cash and Cash Equivalents: For financial statement presentation purposes, the Company considers those short-term, highly liquid investments with original maturities of three months or less to be cash or cash equivalents. Cash and cash equivalents are maintained at banks believed to be stable, occasionally at amounts in excess of federally insured limits, which represents a concentration of credit risk. The Company has not experienced any losses on deposits of cash and cash equivalents to date.
Accounts
Receivable: The Company extends unsecured credit to its customers on a regular basis. Management monitors the payments
on outstanding balances and adjusts the reserve for uncollectible balances to represent future expected credit losses over the life of
the receivables based on past experience, current information and forward-looking economic considerations. The Company controls its credit
risk related to accounts receivable through credit approvals and monitoring, The Company had no customers that generated 10% or more
of its revenue during 2024. As of December 31, 2024, one customer comprised greater than 10% of the outstanding accounts receivable balance
at
Inventories: Inventories are stated at the lower of cost or estimated net realizable value, on a first-in, first-out, or FIFO, basis. The Company uses actual costs to determine its cost basis for inventories. Inventories consist of only finished goods.
Capitalized Software Development Costs: Software development costs for internal-use software are accounted for in accordance with Accounting Standards Codification (“ASC”) 350-40, Internal-Use Software. Development costs that are incurred during the application development stage begin to be capitalized when two criteria are met: (i) the preliminary project stage is completed and (ii) it is probable that the software will be completed and used for its intended function. Capitalization ceases once the software is substantially complete and ready for its intended use. Costs incurred during the preliminary project stage of software development and post-implementation operating stages are expensed as incurred. Amortization is calculated on a straight-line basis over three years which is the estimated economic life of the software and is included in the cost of revenue on the consolidated statements of operations.
The estimated useful lives of software are reviewed at least annually and will be tested for impairment whenever events or changes in circumstances occur that could impact the recoverability of the assets.
Capitalized software development costs for internal-use
software totaled $
| F-8 |
Intangible Assets: Intangible assets represent the value the Company paid to acquire assets including a trademark, patent and web domain on June 23, 2021. The provisional allocation of the purchase price to each of these assets was determined based on ASC 805-50-30, Business Combination, Related Issues, Initial Measurement. These assets are accounted for in accordance with ASC 350-30, Intangibles, General Intangibles Other Than Goodwill. The cost of the assets is amortized over the remaining useful life of the assets as follows:
| U.S. Method Patent | |
| Web Domain | |
| Trademark |
The estimated useful lives and carrying value of the assets are reviewed at least annually or whenever events or circumstances occur which may result in an impact to the value of the assets.
Convertible Notes Payable: The Company accounts for convertible notes deemed conventional and conversion options embedded in non-conventional convertible notes which qualify as equity under Accounting Standards Update (“ASU”) No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including certain convertible instruments and contracts on an entity’s own equity. ASU 2020-06 removes the separation models required for convertible debt with cash conversion features and convertible instruments with beneficial conversion features. It also removes certain settlement conditions that were required for equity contracts to qualify for the derivative scope exception and simplifies the diluted earnings per share calculation for convertible instruments. Accordingly, the Company records, as a discount to convertible notes, the intrinsic value of such conversion options based upon the differences between the fair value of the underlying common stock at the commitment date of the note transaction and the effective conversion price embedded in the note. Debt discounts under these arrangements are amortized over the term of the related debt.
Revenue Recognition: Pursuant to ASC Topic 606, Revenue from Contracts with Customers, or ASC 606, the Company recognizes revenue upon transfer of control of goods or services, in an amount that reflects the consideration that is expected to be received in exchange for those goods. The Company does not allow for the return of products and therefore does not establish an allowance for returns.
To determine the revenue to be recognized for transactions that the Company determines are within the scope of ASC 606, the Company follows the established five-step framework as follows:
| (i) | identify the contract(s) with a customer; | |
| (ii) | identify the performance obligations in the contract(s); | |
| (iii) | determine the transaction price; | |
| (iv) | allocate the transaction price to the performance obligations in the contract(s); and | |
| (v) | recognize revenue when (or as) the Company satisfies a performance obligation. |
The Company sells allergy diagnostic-related products and immunotherapy treatments to physicians. Revenue is recognized once the Company satisfies its performance obligation which occurs at the point in time when title and possession of products have transitioned to the customer, typically upon delivery of the products.
The Company includes shipping and handling fees billed to customers in revenue.
The Company also generates revenue through Software-as-a-Service (SaaS) agreements whereby the Company provides physicians’ practices access to its proprietary internally-developed software that provides clinical decision support and patient monitoring. The agreements provide for either monthly or annual access to the software. The access to the system begins immediately and revenue is recognized over the agreement term.
The Company provides administrative, billing and clinical decision support services utilizing the Company’s internally-developed software. Revenue is recognized each month based on actual services provided during that month.
The Company has entered into an agreement with a third party to provide clinical research services utilizing its proprietary internally-developed software. The agreement details the performance obligations of the Company and revenue is recognized as those obligations are met.
There are several practical expedients and exemptions allowed under ASC 606 that impact timing of revenue recognition and disclosures. The Company elected to treat similar contracts as a portfolio of contracts, as allowed under ASC 606. The contracts that fall within the portfolio have the same terms and management has the expectation that the result will not be materially different from the consideration of each individual contract.
The Company’s revenues consisted of the following:
| For the Years Ended | ||||||||
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Allergy Diagnostic Kit Sales | $ | $ | ||||||
| Integrated Service Program Revenue | ||||||||
| Immunotherapy Treatment Sales | ||||||||
| Clinical Study Revenue | ||||||||
| Subscription Revenue | ||||||||
| Shipping and handling | ||||||||
| Training & Other Revenue | ||||||||
| Total revenue | $ | $ | ||||||
Research and Development: Research and development
expense is primarily related to developing and improving methods related to the Company’s Software as a Service (SaaS) platform.
Research and development expenses are expensed when incurred. For the years ended December 31, 2024 and 2023, there were $
| F-9 |
Income Taxes: The Company accounts for income taxes in accordance with ASC 740, Income Taxes, which requires recognition of estimated income taxes payable or refundable on income tax returns for the current year and for the estimated future tax effect attributable to temporary differences and carry-forwards. Measurement of deferred income tax is based on enacted tax laws including tax rates, with the measurement of deferred income tax assets being reduced by available tax benefits not expected to be realized.
The Company has net operating losses of $
Recently Issued Accounting Standards
In November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which requires all public entities, including public entities with a single reportable segment, to expand disclosures, on an annual and interim basis, about reportable segments and requires more enhanced information about a reportable segment’s expenses, interim segment profit or loss, and how a public entity’s chief operating decision maker uses reported segment profit or loss information in assessing segment performance and allocating resources. ASU 2023-07 is to be applied retrospectively to all prior periods presented in the financial statements with an effective date for all public entities for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company, which has one reportable segment, has adopted ASU 2023-07 and included annual disclosures for all periods presented in the Company’s audited consolidated financial statements and will include all interim disclosures beginning with the Form 10-Q for the period ending March 31, 2025.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires enhanced income tax disclosures, including specific categories and disaggregation of information in the effective tax rate reconciliation, disaggregated information related to income taxes paid, income or loss from continuing operations before income tax expense or benefit, and income tax expense or benefit from continuing operations. ASU 2023-09 is effective for annual periods beginning after December 15, 2024, with early adoption permitted. The Company is currently in the process of evaluating the impact of this pronouncement on it related disclosures.
This Annual Report on Form 10-K does not discuss recent pronouncements that are not anticipated to have a current and/or future impact on or are unrelated to the Company’s financial condition, results of operations, cash flows or disclosures.
| F-10 |
Note 4. Accounts Receivable
Accounts receivable is recorded in the consolidated balance sheets when customers are invoiced for revenue to be collected and there is an unconditional right to receive payment. Timing of revenue recognition may differ from the timing of invoicing customers resulting in deferred revenue until the Company satisfies its performance obligation.
Accounts receivable is presented net of an allowance for doubtful accounts that represents future expected credit losses over the life of the receivables based on past experience, current information and forward-looking economic considerations. The beginning and ending balances of accounts receivable, net of allowance, are as follows:
| December 31, 2024 | December 31, 2023 | |||||||
| Accounts receivable | $ | $ | ||||||
| Allowance for doubtful accounts | ( | ) | ( | ) | ||||
| Accounts receivable, net | $ | $ | ||||||
Note 5. Capitalized Software and Intangible Assets
Non-current assets consist of the following at December 31, 2024 and 2023:
Estimated Useful Life (in years) | December 31, 2024 | December 31, 2023 | ||||||||
| Capitalized software | $ | $ | ||||||||
| Accumulated amortization | ( | ) | ( | ) | ||||||
| Capitalized software, net | $ | $ | ||||||||
| Intangible Assets: | ||||||||||
| U.S. Method Patent | $ | $ | ||||||||
| Web Domain | N/A | |||||||||
| Trademark | N/A | |||||||||
| Total Intangible assets | $ | $ | ||||||||
| Accumulated amortization | ( | ) | ( | ) | ||||||
| Intangible assets, net | $ | $ | ||||||||
Capitalized software represents the development costs
for the Company’s internal-use QHSLab platform software. The Company completed testing of its QHSLab platform software application
at the end of the first quarter of 2022 and began to amortize the capitalized expenses on a straight-line basis over the useful life of
the software. During the years ended December 31, 2024 and 2023 there was $
The intangible assets represent the value the Company
paid to acquire the trademark “AllergiEnd”, the web domain “AllergiEnd.com” along with the U.S. Method Patent
registration relating to the allergy testing kit and related materials the Company distributes to physician clients. The Company acquired
the intangible assets from MedScience Research Group as of June 23, 2021 for total consideration of $
The Company evaluates intangible assets with infinite
lives for impairment at least annually and evaluates intangible assets with finite lives when events or circumstances indicate an
impairment may exist.
| F-11 |
Note 6. Loans Payable
On June 23, 2021, the Company entered into a
purchase agreement to acquire certain assets from MedScience Research Group, Inc (“MedScience”) (See Note 5 –
Capitalized Software and Intangible Assets for additional information). As part of that purchase agreement, the Company issued a
Promissory Note with a principal sum of $
The Promissory
Note provides for various events of default similar to those provided for in similar transactions, including the failure to timely pay
amounts due thereunder. In the event of a default, the interest rate on the outstanding principal would increase to a predetermined interest
rate defined in the Promissory Note. The Company has deferred certain principal payments and MedScience has indicated that it would
forbear taking any action but reserves all of its rights under its agreement. The most recent notice of forbearance was received on March
20, 2025. The combined principal due along with accrued interest as of December 31, 2024 is $
On August 12,
2024, the Company entered into a fixed-fee short-term loan with its merchant bank and received $
| F-12 |
Note 7. Convertible Notes Payable
Convertible notes payable at December 31, 2024 and 2023 consist of the following:
| December 31, 2024 | December 31, 2023 | |||||||
| Note 1 – Shareholder | $ | $ | ||||||
| Note 2 – Mercer Note | ||||||||
| Note 3 – Mercer Note #2 | ||||||||
| Less: current portion | ||||||||
| Non-current portion | $ | $ | ||||||
Note 1 – Effective May 7, 2021, the Company issued a Convertible Promissory Note in the principal amount of $ to a shareholder (Note 1). The Note bears interest at the rate of % per annum and matures on (the “Maturity Date”) at which date all outstanding principal and accrued and unpaid interest are due and payable. On October 1, 2022, the Maturity Date of Note 1 was extended to December 31, 2023 and further extended to December 31, 2024 during the quarter ended March 31, 2024. As of December 31, 2024 and 2023, this Note had $ and $, respectively, of accrued interest recorded in other current liabilities on the consolidated balance sheets. Following the year-ended December 31, 2024, the Maturity Date of Note 1 was further extended to December 31, 2025.
Note 2 – Effective August 10, 2021, the Company
entered into a Securities Purchase Agreement with an accredited investor pursuant to which it issued to the investor an Original Issue
Discount Secured Convertible Promissory Note (the “$806,000 Note”) in the principal amount of $
The principal amount of the
$806,000 Note and all interest accrued thereon is payable on August 10, 2022, and is secured by a lien on substantially all of the Company’s
assets. The $806,000 Note provides for interest at the rate of
The $806,000 Note provides for various events of default similar to those provided for in similar transactions, including the failure to timely pay amounts due thereunder. In the event of a default, the interest rate on the outstanding principal would increase during the continuance of the default to a Default Interest Rate defined in the $806,000 Note. Additionally, all outstanding amounts would be paid at the holder’s discretion at a Mandatory Default Amount also defined in the $806,000 Note.
On November 11, 2021, Mercer
Street Global Opportunity Fund, LLC (“Mercer Fund”), converted $
| F-13 |
The
As a result of the issuance of a $
On October 5, 2023, at the request of Mercer Fund,
the Company agreed to reduce the conversion price with respect to $
On March 4, 2024, at the request of Mercer Fund, the
Company agreed to reduce the conversion price with respect to $
On February 19, 2024, the
Company received the most recent notice from the manager of Mercer Fund of its agreement to forebear from the exercise of any rights it
might have as a result of any defaults under the $806,000 Note and the related documents between the Company and the Mercer Fund, provided
that the Mercer Fund reserved all of its rights under such agreements. The $806,000 Note continued to accrue interest at
On February 20, 2025, the
Company received a Notice of Default from Mercer Fund in connection with the $806,000 Note. Under the terms of the $806,000 Note, a failure
to pay the principal and interest when due constitutes an Event of Default under Section 7(a)(i) of the Note. The Note matured on
As of December 31, 2024, all original issue discount
and debt issuance costs, including the allocated relative fair value of the Warrants, have been recognized. The remaining principal balance
of $
Note 3 – Effective July 19, 2022, the Company
entered into a Securities Purchase Agreement with Mercer Fund pursuant to which it issued an Original Issue Discount Secured Convertible
Promissory Note (the “$440,000 Note”) in the principal amount of $
The principal amount of the
$440,000 Note and all interest accrued thereon is payable on July 19, 2023, and are secured by a lien on substantially all of the Company’s
assets. The $440,000 Note provides for interest at the rate of
The $440,000 Note provides for various events of default similar to those provided for in similar transactions, including the failure to timely pay amounts due thereunder. The $440,000 Note provides further that the Company will be liable to the Mercer Fund for various amounts, including the cost of a buy-in, if the Company shall default in its obligation to register the shares issuable upon conversion of the $440,000 Note for sale by the Mercer Fund under the Securities Act or otherwise fails to facilitate Buyer’s sale of the shares issuable upon conversion of the $440,000 Note as required by the terms of the $440,000 Note. In the event of a default, the interest rate on the outstanding principal would increase during the continuance of the default to a Default Interest Rate defined in the $440,000 Note. Additionally, all outstanding amounts would be paid at the holder’s discretion at a Mandatory Default Amount also defined in the $440,000 Note.
On February 19, 2024, the
Company received the most recent notice from the manager of the Mercer Fund, LLC that it agreed to forebear from exercising any rights
it might have as a result of any defaults under the $
On February 20, 2025, the
Company received a Notice of Default from Mercer Fund in connection with the $440,000 Note. Under the terms of the $440,000 Note, a failure
to pay the principal and interest when due constitutes an Event of Default under Section 7(a)(i) of the Note. The Note matured on
The
| F-14 |
The Company accounts for the allocation of its issuance costs related to its Warrants in accordance with ASC 470-20, Debt with Conversion and Other Options. Under this guidance, if debt or stock is issued with detachable warrants, the proceeds need to be allocated to the two instruments using either the fair value method, the relative fair value method, or the residual value method. The Company used the relative fair value at the time of issuance to allocate the value received between the convertible note and the warrants.
The Company estimated the fair value of the Warrants utilizing the Black-Scholes pricing model, which is dependent upon several assumptions such as the expected term of the Warrants, expected volatility of the Company’s stock price over the expected term, expected risk-free interest rate over the expected term and expected dividend yield rate over the expected term. The Company believes this valuation methodology is appropriate for estimating the fair value of warrants. The value allocated to the relative fair value of the Warrants was recorded as debt issuance costs and additional paid in capital.
The principal, net of the original issue discount and debt issuance costs, including the allocated relative fair value of the Warrants, which are being recognized over the life of the $440,000 Note, along with associated interest, is recorded with current liabilities on the Company’s audited consolidated balance sheets.
As of December 31, 2024, all original issue discount
and debt issuance costs, including the allocated relative fair value of the Warrants, have been recognized. The remaining principal balance
of $
Note 8. Preferred Stock
Issuance of Series A Preferred Stock
The shares of Series A Preferred Stock have a stated
value of $ per share and are initially convertible into shares of common stock at a price of $
Issuance of Series A-2 Preferred Stock
The shares of Series A-2 Preferred Stock have a stated
value of $
Holders of the Series A-2 Convertible Preferred Stock will vote on an as converted basis with the holders of the Company’s common stock and Series A Preferred Stock as to all matters to be voted on by the holders of the common stock. Each Series A-2 Preferred Share shall be entitled to a number of votes equal to five times the number of shares of common stock into which it is then convertible on the applicable record date.
Holders of the Series A-2 Convertible Preferred Stock
are entitled to receive cumulative dividends at an annual rate of
| F-15 |
The Company calculates net income or loss per common share in accordance with ASC 260, Earnings Per Share. Basic and diluted net income (loss) per common share were determined by dividing net income (loss) applicable to common stockholders by the weighted average number of common shares outstanding during the period. The Company’s potentially dilutive shares, which include outstanding common stock options, common stock warrants, convertible debt and preferred shares have not been included in the computation of diluted net loss per share for the years ended December 31, 2024 and 2023 as the result would be anti-dilutive.
| Years Ended December 31, | ||||||||
| 2024 | 2023 | |||||||
| Stock options | ||||||||
| Stock warrants | ||||||||
| Total shares excluded from calculation | ||||||||
During the years ended December 31, 2024 and 2023, there was $ and $, respectively, in stock-based compensation associated with stock options included in research and development expense. Additionally, during the same periods there was $ and $, respectively, of expense associated with shares issued for services recorded in Research and development expense.
There were options granted during the years ended December 31, 2024 and 2023. There were options exercised, forfeited or cancelled during either period.
As of December 31, 2024, all compensation related to the outstanding options has been recognized. The options were expensed over the vesting period for each Advisor.
| Date Issued | Number Outstanding | Number Exercisable | Exercise Price | Expiration Date | ||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| Total | ||||||||||||||
Warrants outstanding at December 31, 2024 consist of:
| Date Issued | Number Outstanding | Number Exercisable | Exercise Price | Expiration Date | ||||||||||
| $ | ||||||||||||||
| Total | ||||||||||||||
| F-16 |
Note 11. Related-Party Transactions
Due to Related Parties: Amounts due to related
parties consist of cash advances received from our principal shareholder, bear no interest and are due on demand. These terms and conditions
may not be indicative of what a third-party investor may agree to. As of December 31, 2024 and 2023 amounts due to related-parties totaled
$
Convertible notes payable, related party: See Note 7.
Note 12. Income Taxes
The Company accounts for income taxes in accordance with ASC 740, Income Taxes, which requires recognition of estimated income taxes payable or refundable on income tax returns for the current year and for the estimated future tax effect attributable to temporary differences and carry-forwards. Measurement of deferred income tax is based on enacted tax laws including tax rates, with the measurement of deferred income tax assets being reduced by available tax benefits not expected to be realized. Given its history of net operating losses, the Company has determined that it is more likely than not that it will not be able to realize the tax benefit of its net operating loss carryforwards. Accordingly, the Company has not recognized a deferred tax asset for this benefit.
The valuation allowance at December 31, 2024 and 2023
was $
Reconciliation between the provision for income taxes and the expected tax benefit using the federal statutory rate of 21% for 2024 and 2023 are as follows:
| For the Years Ended | ||||||||
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| Income tax at federal statutory rate | % | % | ||||||
| Valuation allowance | ( | )% | ( | )% | ||||
| Income tax expense | ||||||||
The Company has net operating losses of $
Note 13. Segment Information
The Company’s Chief Executive Officer (“CEO”) is the CODM and allocates resources and assesses performance based upon consolidated Net loss that is included in the accompanying consolidated statements of operations. Accordingly, the Company operates as a single operating segment. The measure of segment assets is reflected as Total assets in the accompanying consolidated balance sheets. The Company’s revenue is derived from providing Primary Care Physicians (“PCP’s”) with relevant value-based tools to enable them to diagnosis and treat their patients. See additional discussion of revenue in Note 3 - Basis of Presentation.
Note 14. Commitments and Contingencies
There are no pending or threatened legal proceedings as of December 31, 2024. The Company has no non-cancellable operating leases.
Note 15. Subsequent Events
On January 6, 2025, Mercer Street Global Opportunity
Fund, LLC, converted $
On January 13, 2025, Mercer Street Global Opportunity
Fund, LLC, converted $
On February 5, 2024, the Company entered into an Investor Relations Consulting Agreement with Hayden IR, LLC (HIR) to which HIR will provide investor relations services to the Company. In consideration of these services, HIR received a one-time payment of shares of the Company’s common stock (the “Share Payment”).
On February 20, 2025, the Company received a Notice
of Default from Mercer Street Global Opportunity Fund, LLC (the “Lender”) in connection with the $806,000 Note and the $440,000
Note. Under the terms of the Notes, a failure to pay the principal and interest when due constitutes an Event of Default under Section
7(a)(i) of the Notes. The Notes matured on
| F-17 |