LUDG 10-K
Ludwig Enterprises, Inc. (LUDG)
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LUDWIG ENTERPRISES, INC.
INDEX TO ANNUAL REPORT ON FORM 10-K
For the Fiscal Year ended December 31, 2025
Items in Form 10-K
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DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report 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. For example, statements included in this Annual Report regarding our financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about future product demand, supply, manufacturing, costs, marketing and pricing factors are all forward-looking statements. When we use words like “intend,” “anticipate,” “believe,” “estimate,” “plan” or “expect,” or other words of a similar import, we are making forward-looking statements. We believe that the assumptions and expectations reflected in such forward-looking statements are reasonable, based upon information available to us on the date hereof, but we cannot assure you that these assumptions and expectations will prove to have been correct or that we will take any action that we may presently be planning. We have disclosed certain important factors that could cause our actual results to differ materially from our current expectations elsewhere in this Annual Report. You should understand that forward-looking statements made in this Annual Report are necessarily qualified by these factors. We are not undertaking to publicly update or revise any forward-looking statement if we obtain new information or upon the occurrence of future events or otherwise.
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PART I
Item 1. Business
In this Annual Report, “we,” “us” and “our” refer to Ludwig Enterprises, Inc.
Background
Originally incorporated in 1988, and reorganized as a Nevada corporation in 2006, Ludwig pivoted in late 2021 to focus on genomic diagnostics, following the identification of mRNA-based testing as a commercially viable opportunity. Our technology builds on advances made possible by the Human Genome Project, which enabled large-scale genomic applications, but applies a novel mRNA-based approach focused on dynamic gene expression. The company began actively pursuing its oncology diagnostics strategy in early 2022. Since that time, we have advanced our first product candidate, the Revealia™ Breast test, which we anticipate trial-launching in the second quarter of 2026.
Our Focus
Ludwig is an early-stage genomic technology company focused on developing screening tests for inflammation-related chronic diseases, including cancers. We believe we are the first to employ a non-invasive cheek swab to collect mRNA samples in quantities sufficient for analysis. Our approach seeks to enable earlier detection of inflammation-driven disease and to support personalized treatment decisions.
Our platform integrates mRNA inflammatory biomarkers, proprietary machine-learning algorithms, and at-home cheek swab collection kits designed to provide a differentiated and patient-friendly approach to cancer screening.
Chronic inflammation is implicated in a wide variety of diseases, including cardiovascular disease, stroke, cancer, diabetes, arthritis, autoimmune disorders, and neurodegenerative conditions. According to Nature Medicine (2019), more than half of all deaths worldwide are attributable to inflammation-related diseases. By addressing inflammation at the molecular level, we believe our technology may provide an early warning system for conditions that today are often detected only after substantial damage has occurred.
Our business model combines a business-to-business-to-consumer (B2B2C) strategy with partnerships through CLIA-certified laboratories. We intend to offer home collection kits directly to patients, supported by certified genetic counselors, while also enabling independent laboratories to provide the Revealia™ Breast test as a Laboratory Developed Test (LDT). Our commercialization plan is dependent on securing funding to fund additional clinical validation studies, expand laboratory infrastructure, and build distribution capabilities.
We rely on proprietary methods and intellectual property to differentiate our products. We currently have two patent families covering diagnostic tests using mRNA for identifying breast, bladder, colon, ovarian and other cancers, with filings in the United States, Europe, Australia, Canada, Israel, India, South Korea, and other jurisdictions.
Our competitive positioning is based on the use of mRNA biomarkers, which reflect active disease processes, rather than DNA-based testing that primarily identifies inherited traits. We believe this distinction positions us in a differentiated category within the broader genetic testing market.
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Recent Developments
On June 5, 2025, our Board of Directors (the “Board”) received a letter of resignation from Dr. Marvin S. Hausman from his position on the Board, Dr. Hausman will remain in his position as Chief Science Officer of the Company. Dr. Hausman’s decision to resign was not due to any disagreement with the Company, the Board or any member of the Company’s management.
On June 23, 2025, the Board appointed a new independent director, Garth Lees-Rolfe, to hold office until the earlier of the expiration of the term of office, a successor is duly elected and qualified, or the earlier of his death, resignation, disqualification, or removal.
On June 27, 2025, we filed a Definitive Information Statement in connection with the action by written consent of the Company’s Board of Directors and a majority of our shareholders taken without a meeting on June 16, 2025, to approve the following corporate actions: (i) to effect a reverse stock split of our outstanding shares of Common Stock between a ratio of 1- for-50 and 1-for-250 (the “Reverse Stock Split”); (ii) a change to the Company’s name from “Ludwig Enterprises, Inc.” to “Revealia Diagnostics, Inc.”; (iii) pursuant to Nevada Revised Statute (“NRS”) 78.0296, to ratify and approve all past corporate actions, including but not limited to: (a) issuances of our Common Stock as authorized by the Board, (b) reverse stock splits effected by us during 2009, 2011, and 2012, (c) appointments of the current officers and directors of the Corporation, (d) any and all other defective or irregular corporate actions undertaken by us, our officers, directors, and beneficial holders; (iv) pursuant to NRS 78.0296, to ratify and approve all past corporate actions, including but not limited to: (a) the reverse stock splits effected by us in 2009, 2011, and 2012; (b) the formation and issuance of our convertible preferred stock on December 13, 2022, and July 1, 2022; (c) any subsequent corporate actions of the holders of our outstanding preferred stock; (d) any additional defective corporate actions carried out by the Corporation’s officers, directors, and beneficial holders; and (v) the filing of Amended and Restated Articles of Incorporation of the Company (the “Amended and Restated Articles”), pursuant to NRS Section 78.403 and consistent with NRS 78.385 and 78.390 (collectively (i), (ii), (iii), (iv), and (v) are the “Corporate Actions”).
On July 24, 2025, Charles T. Todd Jr. resigned as Chief Executive Officer of Ludwig Enterprises, Inc. (the “Company”), effective 30 days following the notification date (i.e. effective August 23, 2025). Mr. Todd’s resignation was not a result of any disagreement with the Company on any matter relating to the Company’s operations, policies or practices.
On September 5, 2025, the Board appointed a new independent director, Corain McGinn, to hold office until the earlier of the expiration of the term of office, a successor is duly elected and qualified, or the earlier of his death, resignation, disqualification, or removal.
On October 1, 2025, the Board appointed Jose Antonio Reyes to the position of Interim CEO to hold such office until the Board appoints a permanent Chief Executive Officer or until his earlier resignation or removal.
Company Overview
Ludwig is an early-stage genomic technology company focused on developing screening tests for inflammation-related chronic diseases, including cancers. We believe we are the first to employ a non-invasive cheek swab to collect mRNA samples in quantities sufficient for analysis. Our approach seeks to enable earlier detection of inflammation-driven disease and to support personalized treatment decisions.
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Originally incorporated in 1988, and reorganized as a Nevada corporation in 2006, Ludwig pivoted in late 2021 to focus on genomic diagnostics, following the identification of mRNA-based testing as a commercially viable opportunity. Our technology builds on advances made possible by the Human Genome Project, which enabled large-scale genomic applications, but applies a novel mRNA-based approach focused on dynamic gene expression. The company began actively pursuing its oncology diagnostics strategy in early 2022. Since that time, we have advanced our first product candidate, the Revealia™ Breast test, which we anticipate trial-launching in the second quarter of 2026.
Our platform integrates mRNA inflammatory biomarkers, proprietary machine-learning algorithms, and at-home cheek swab collection kits designed to provide a differentiated and patient-friendly approach to cancer screening.
Our business model combines a business-to-business-to-consumer (B2B2C) strategy with partnerships through CLIA-certified laboratories. We intend to offer home collection kits directly to patients, supported by certified genetic counselors, while also enabling independent laboratories to provide the Revealia™ Breast test as a Laboratory Developed Test (LDT). Our commercialization plan is dependent on securing funding to fund additional clinical validation studies, expand laboratory infrastructure, and build distribution capabilities. See “Commercialization Model” and “Government Regulation” for additional information.
We rely on proprietary methods and intellectual property to differentiate our products. We currently have two patent families covering diagnostic tests using mRNA for identifying breast, bladder, colon, ovarian and other cancers, with filings in the United States, Europe, Australia, Canada, Israel, India, South Korea, and other jurisdictions. For additional information, see “Intellectual Property.”
Our competitive positioning is based on the use of mRNA biomarkers, which reflect active disease processes, rather than DNA-based testing that primarily identifies inherited traits. We believe this distinction positions us in a differentiated category within the broader genetic testing market. See “Competition.”
Ludwig is headquartered in Miami, Florida, with operations currently limited to the United States. While our commercial focus is domestic in the near term, we have filed international patent applications and may pursue opportunities outside the U.S. in the future.
Additional information regarding our products, technology, commercialization plans, competition, intellectual property and regulatory considerations is set forth below.
All testing is intended to be conducted under CLIA/CAP oversight. Our tests have not been cleared or approved by the U.S. Food and Drug Administration (FDA). See “Government Regulation.”
Industry Background and Market Opportunity
Chronic diseases remain the leading cause of death and disability worldwide. Conditions such as cardiovascular disease, stroke, cancer, diabetes, arthritis, autoimmune disorders, and neurodegenerative diseases account for the majority of healthcare costs and contribute to declining quality of life. According to Nature Medicine (2019), more than half of all deaths worldwide are attributable to inflammation-related diseases.
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These findings underscore inflammation as an important diagnostic and therapeutic target, including its role in cancer development through the tumor microenvironment, where immune and inflammatory signals can promote tumor initiation and progression.
At the same time, healthcare is shifting toward a more proactive, preventive, and personalized approach. Many diseases are still detected only after irreversible damage has occurred, resulting in higher costs and poorer outcomes. This shift highlights the unmet need for tools that can identify disease processes earlier and support individualized treatment decisions.
Market Opportunity
According to Grand View Research’s 2025 report1, the U.S. breast cancer diagnostics market is projected to reach approximately $4.5 billion by 2033, growing at a CAGR of 8.21% from 2025 to 2033. According to the American Cancer Society, breast cancer is the most commonly diagnosed cancer in the United States, with an estimated 317,000 new cases in 2025. According to Global Market Insights, the U.S. cancer diagnostics market was valued at approximately $63.1 billion in 2025 If validated and successfully commercialized, we believe our tests could enable us to participate in these markets.
The following figures2,3,4,5 summarize selected estimates regarding the size of the cancer diagnostics market and the incidence of common cancer types in the United States and globally, based on publicly available industry and epidemiological data. These estimates are provided for context and do not represent forecasts of our future performance.
| ● | ~$2.4 Billion – Estimated value of the U.S. Breast Cancer market in 2025 |
| ● | ~$5 Billion – Estimated value of the Global Breast Cancer market growing at a CAGR of 7.6% |
| ● | $148.2 Billion – Forecasted US Total Cancer Diagnostic Market by 2035 growing at a CAGR of 8.6% |
| ● | $408.9 Billion – Forecasted Global Total Cancer Diagnostic Market by 2035 growing at a CAGR of 9.1% |
| 1 | U.S. Breast Cancer Diagnostics Market (2025 - 2033). (2025). Grand View Research. Retrieved January 8, 2026, from https://www.grandviewresearch.com/industry-analysis/us-breast-cancer-diagnostics-market-report |
| 2 | Straits Research Private Limited - Garner Insights. (2024, September 30). Breast cancer diagnostics market to worth USD 9.65 billion by 2033: With 7.62% CAGR. GlobeNewswire News Room. https://www.globenewswire.com/news-release/2024/09/30/2955565/0/en/Breast-Cancer-Diagnostics-Market-to-Worth-USD-9-65-Billion-By-2033-With-7-62-CAGR.html |
| 3 | Faizullabhoy , M., & Wani, G. (2025, December). Cancer diagnostics market size & share, growth analysis 2035. Global Market Insights Inc. https://www.gminsights.com/industry-analysis/cancer-diagnostics-market |
| 4 | U.S. Breast Cancer Diagnostics Market (2025 - 2033). (2025). Grand View Research. Retrieved January 8, 2026, from https://www.grandviewresearch.com/industry-analysis/us-breast-cancer-diagnostics-market-report |
| 5 | American Cancer Society. Cancer Facts & Figures 2025. Atlanta: American Cancer Society; 2025 |
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Survival outcomes highlight the importance of earlier detection. According to the American Cancer Society6, and as illustrated in the accompanying graph, the five-year survival rate for localized breast cancer, in which the disease has not spread beyond the initial site, exceeds 99%. For regional breast cancer, wherein the disease has spread to nearby lymph nodes or structures, the five-year survival rate declines to approximately 87%. For distant breast cancer, wherein the disease has metastasized to organs such as the lungs, liver, or bones, the five-year survival rate is approximately 32%. These differences underscore the potential clinical benefit of tools that may identify disease earlier in its course.
| 6 | The American Cancer Society. (2025, January 16). Survival rates for breast cancer. American Cancer Society. https://www.cancer.org/cancer/types/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-survival-rates.html |
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Despite an improvement in attitudes toward early screening, gaps still remain in early detection. As reflected in national survey data reported by the Centers for Disease Control and Prevention, National Center for Health Statistics7 (see chart below), nearly 80% of U.S. women aged 50–74 report having had a mammogram within the prior two years, yet breast cancer continues to be the most commonly diagnosed cancer. This underscores the unmet need for complementary diagnostic tools that can identify disease processes earlier and more accurately. We believe that through the launch of our more convenient, non-invasive Revealia™ Breast test, we can help to close these gaps.
| 7 | Sabatino SA, Thompson TD, Croswell JM, Villarroel MA, Rodriguez JL, Adam EE, et al. Use of Cancer Screening Tests, United States, 2023. Prev Chronic Dis 2025;22:250139. DOI: http://dx.doi.org/10.5888/pcd22.250139 |
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Current genetic testing methods, such as DNA-based assays, provide information on inherited risk but are limited in their ability to capture real-time disease activity. Messenger RNA (mRNA), by contrast, reflects active gene expression within living cells and provides a dynamic, real-time snapshot of biological processes. Peer-reviewed studies have shown that changes in mRNA expression correlate with disease onset and progression. We believe this makes mRNA a valuable diagnostic target.
By measuring variations in mRNA levels, it may be possible to identify early indicators of disease activity that DNA testing alone cannot reveal. Our approach is designed to harness this principle through a non-invasive cheek swab collection method and proprietary machine-learning algorithms that analyze mRNA signatures associated with chronic inflammation and cancer. In parallel, consumer demand for healthcare is shifting toward models that emphasize greater patient control, transparency, and convenience. Following the COVID-19 pandemic, surveys indicate that many health-conscious individuals are seeking science-backed solutions that also provide a more streamlined experience, such as at-home collection and digital result access. We believe these trends support our business-to-business-to-consumer (B2B2C) commercialization strategy, which emphasizes institutionally enabled access to convenient, at-home testing experiences.
Survey research further suggests that consumers are receptive to genetic testing when actionable health insights are offered. In one study undertaken by YouGov8, 65% of adults indicated they would take a DNA test if it could provide meaningful information about their risk of developing a serious health condition (See chart below). The results indicate that participants’ perceived risk of disease would drive interest in genetic testing and screening. We believe this willingness to engage supports adoption of at-home genomic diagnostics.
| 8 | Orth, T. (2022, February 25). DNA tests: Many Americans report surprises and new connections. YouGov. https://today.yougov.com/society/articles/41232-dna-tests-many-americans-report-surprises-and-new- |
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Disclaimer: The use of mRNA as a diagnostic tool described here is investigational. Our tests have not been cleared or approved by the U.S. Food and Drug Administration (FDA). See “Government Regulation.”
Products and Services
Lead Product Candidate: Revealia™ Breast
Our initial product candidate is the Revealia™ Breast test, a non-invasive cheek swab assay designed to detect molecular signatures in mRNA expression associated with the presence of breast cancer. Samples are collected by patients at home using a proprietary kit and analyzed with our 48-gene inflammatory biomarker panel. Results are interpreted through ensemble machine-learning algorithms developed by the company.
We intend the Revealia™ Breast test to serve as a screening tool that may indicate whether an individual should undergo further diagnostic evaluation. The test is not designed to provide a definitive diagnosis. The test is intended to be used as an aid to risk assessment and to inform whether further diagnostic evaluation may be warranted. We anticipate initially offering the test as a Laboratory Developed Test (LDT) performed in CLIA-certified, CAP-accredited laboratories.
To date, we have completed preliminary clinical and analytical validation studies as part of an ongoing, multi-site Institutional Review Board–approved research program, using our 48-gene inflammatory biomarker panel for analysis. Subject to successful validation and the availability of funding, we anticipate a trial launch of the Revealia™ Breast test in 2026.
We plan to support consumers with access to certified genetic counselors, who can provide education and guidance regarding test results in coordination with their healthcare providers. All testing is intended to be conducted in CLIA-certified, CAP-accredited laboratories. Our tests have not been cleared or approved by the U.S. Food and Drug Administration (FDA). See “Government Regulation.”
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Preliminary Clinical and Analytical Validation
We have conducted preliminary clinical and analytical validation studies as part of an ongoing, multi-site Institutional Review Board–approved research program evaluating mRNA-based biomarkers associated with inflammation-related cancers. To date, more than 3,000 patient samples have been collected across more than 40 U.S. clinical sites, encompassing both cancer-positive and non-cancer control populations across multiple cancer types, including breast, bladder, and colorectal cancer.
As of the most recent completed analyses, a subset of 345 patient samples has been analyzed using our proprietary 48-gene inflammatory biomarker panel and ensemble machine-learning algorithms. Within this analyzed subset, 249 samples were evaluated for breast cancer, including 136 samples from patients with confirmed breast cancer diagnoses and 113 samples from patients without breast cancer serving as controls. All results were validated against confirmed clinical diagnoses.
Based on these preliminary analyses, our ensemble approach achieved sensitivity of approximately 92%, specificity of 54%, negative predictive value of 86%, and an area under the curve (AUC) of 76%. In addition, the validation studies demonstrated an F1-score of 77.6%, reflecting a favorable balance between recall and precision. These results compare favorably to published benchmarks for mammography.
Extensive IRB Dataset with Peer-Reviewed* Results
Clinical Validation Progress
Ongoing multi-site IRB study
| ● | 3,000+ patient samples collected across 40 clinical sites |
| ● | 345 samples analyzed to date |
| ● | Includes both cancer-positive and non-cancer (control) patients |
| ● | Covers bladder, breast, and colorectal |
Phase 1: Breast Cancer Cohort
Of the 345 samples analyzed to date, 249 were tested for breast cancer:
| ● | 113 without breast cancer (controls) |
| ● | 136 with confirmed breast cancer |
All results validated against confirmed clinical diagnoses
Validated Clinical Performance
Tests showed that Revealia:
| ● | Enables breast cancer detection with ~92% sensitivity |
Rules out breast cancer with ~86% negative predictive value
Next Steps
| ● | Continued metadata analysis across the breast cancer cohort |
| ● | Additional insights shared as validation progresses |
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Definition of validated performance metrics: Sensitivity is how good the test is at not missing cancer when it’s really there. If 100 people actually have cancer, and the test finds 92 of them, that’s 92% sensitivity. Negative Predictive Value (NPV) is how reliable a negative result is. If 100 people truly do not have cancer and 86 of them test negative, that’s an 86% negative predictive value.
We intend to continue expanding validation through additional observational analyses and planned studies enrolling approximately 600 patients across breast, lung, ovarian, and pancreatic cancers. Institutional Review Board approval has been obtained, and these studies are expected to begin within six months. These studies are designed to incorporate AJCC staging criteria and associated clinical metadata.
These results are from preliminary validation studies and have not been reviewed or approved by the U.S. Food and Drug Administration (FDA). All testing is intended to be conducted in CLIA-certified, CAP-accredited laboratories. See “Government Regulation.”
Pipeline Expansion
Building on the same technology, we are developing additional assays using our mRNA biomarker panel and machine-learning platform. These candidates target other cancers where early detection is critical and current screening methods are limited. Our pipeline includes tests in development for lung, ovarian, and pancreatic cancers, which were selected based on the prevalence of inflammation-related pathways in their disease biology and the significant unmet need for accessible, non-invasive screening options. We believe the same cheek-swab–based sample collection and analytic approach used in the Revealia™ Breast test can be adapted to detect molecular signatures associated with these cancers.
The following timeline illustrates our anticipated sequencing for evaluating and introducing our tests for additional cancer indications, subject to clinical validation, regulatory considerations, and available funding.
Beyond oncology, emerging evidence suggests our platform may also be applicable to inflammation-driven conditions such as cardiovascular disease, neurodegenerative disorders including Alzheimer’s and Parkinson’s disease, and metabolic diseases such as diabetes. We intend to evaluate these areas as longer-term opportunities, subject to validation.
All pipeline products, if validated, will be offered as Laboratory Developed Tests (LDTs) performed in CLIA-certified, CAP-accredited laboratories. Our tests have not been cleared or approved by the U.S. Food and Drug Administration (FDA). See “Government Regulation.”
Technology Platform
Our technology platform integrates three key components: non-invasive sample collection, genomic analysis, and machine learning–based interpretation. Together, these elements are designed to provide a scalable system for early detection across multiple disease areas.
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mRNA-Based Signal Analysis
Genomic diagnostic approaches differ based on the biological signals they measure. DNA-based assays primarily identify inherited genetic variants or tumor-derived DNA fragments and typically require sufficient tumor burden for reliable detection9. Messenger RNA (mRNA), by contrast, reflects active gene expression and immune-response signaling within living cells, and cell state is commonly characterized through transcriptomic (mRNA) profiles10. Changes in mRNA expression can occur as cells respond dynamically to inflammatory and oncogenic processes associated with disease development11.
Our platform analyzes mRNA expression patterns captured from oral epithelial cells to identify biomarker signatures associated with inflammation-related cancers. This biological approach is intended to support detection based on real-time cellular activity rather than static genetic alterations.
Sample Collection
Patients collect samples at home using a proprietary cheek swab kit designed for ease of use and stability in transport. Cheek swabs provide access to messenger RNA (mRNA) in sufficient quantity to enable analysis of inflammatory gene expression patterns.
Biomarker Analysis
The collected samples are analyzed with our proprietary 48-gene inflammatory biomarker panel using next-generation sequencing methods. This panel was selected based on prior research demonstrating the involvement of inflammatory signaling pathways in cancer and other chronic diseases.
Machine Learning Algorithms
Data from the biomarker panel are processed using ensemble machine-learning models. During development, we evaluated multiple classification approaches, including random forests, logistic regression, and gradient boosting, before adopting a probability-weighted ensemble model that improved predictive performance. To optimize biomarker selection, we conducted an exhaustive evaluation of approximately 12.2 million permutations of our 48-gene panel. This process yielded a six-gene classifier that demonstrated favorable sensitivity, specificity, and balanced performance metrics in distinguishing breast cancer cases from controls. This six-gene classifier represents a proprietary breast cancer–specific mRNA signature derived from our broader 48-gene inflammatory biomarker panel. These algorithms are designed to generate a predictive index by integrating multiple classifiers to improve sensitivity and specificity.
| 9 | Han, X., Wang, J., & Sun, Y. (2017, April 17). Circulating tumor DNA as biomarkers for cancer detection. Genomics, proteomics & bioinformatics. https://pmc.ncbi.nlm.nih.gov/articles/PMC5414889 |
| 10 | Marr, C., Zhou, J. X., & Huang, S. (2016, May 23). Single-cell gene expression profiling and cell state dynamics: Collecting data, correlating data points and connecting the dots. Current opinion in biotechnology. https://pmc.ncbi.nlm.nih.gov/articles/PMC5130334/ |
| 11 | Greten, F. R., & Grivennikov, S. I. (2019, July 16). Inflammation and cancer: Triggers, mechanisms, and consequences. Immunity. https://pmc.ncbi.nlm.nih.gov/articles/PMC6831096 |
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Integrated Platform
Collectively, the sample collection process, biomarker analysis, and algorithmic interpretation form a platform that can be adapted to multiple indications. While our initial focus is oncology, the architecture is intended to extend to other conditions where inflammation plays a central role, including cardiovascular, autoimmune, and neurodegenerative diseases.
All testing described in this section is intended to be conducted in CLIA-certified, CAP-accredited laboratories. Our technology platform has not been cleared or approved by the U.S. Food and Drug Administration (FDA) as an LDT. See “Government Regulation.”
Commercialization Model
We intend to introduce the Revealia™ Breast test through a phased commercialization model. Subject to funding and validation, we anticipate an initial trial launch in early 2026.
Commercialization Strategy and Payer Alignment
Our commercialization strategy is informed by prior successful diagnostic launch models that combined early clinical validation, engagement with healthcare providers and healthcare systems, payer engagement, and phased expansion across distribution channels. In particular, we plan to adapt elements of the go-to-market strategy used by Cologuard®, specifically Cologuard’s approach of introducing their screening test through clinically mediated access and payer alignment prior to broader national adoption. While we believe that we have the potential to achieve market penetration with this strategy, we can make no assurances that our approach will be successful.
We believe this approach supports earlier revenue generation, accelerates the accumulation of real-world clinical data, and aligns adoption incentives among providers, employers, and payers. Under this model, we intend to pursue a multi-channel distribution strategy that includes business-to-business-to-consumer (B2B2C) relationships, employer and captive insurer partnerships, and, over time, broader third-party payer coverage.
In November 2025, Abbott announced a definitive agreement to acquire Exact Sciences Corporation, the developer of Cologuard®, for approximately $21 billion12. We believe this transaction underscores the strategic value that large healthcare companies place on scalable, early detection diagnostic platforms with established payer relationships. While we believe that we have the potential to achieve market penetration with this strategy, we can make no assurances that our approach will be successful.
B2B2C Fulfillment and At-Home Testing
Access to the Revealia™ Breast test is intended to be enabled primarily through business-to-business-to-consumer (B2B2C) channels, including healthcare providers, employer and captive insurer partnerships, and other clinically affiliated access points. Under this model, tests are expected to be made available through institutionally enabled ordering pathways rather than direct retail purchase once a test is ordered through these channels, patients will receive an at-home collection kit for sample self-collection.
We intend to support this model through an operational infrastructure that enables kit fulfillment, sample return, and results delivery. Patients will collect samples at home using a proprietary cheek-swab kit and return them to a CLIA-certified, CAP-accredited laboratory for analysis. Patients will have access to certified genetic counselors to review test results, either directly or in coordination with their healthcare providers, as appropriate, and we expect these counseling services to be integrated into the ordering and results workflow rather than provided solely through general awareness or education initiatives.
| 12 | Exact Sciences, Inc. (2025, November 20). Abbott to acquire Exact Sciences, a leader in large and fast-growing cancer screening and precision. Abbott to acquire Exact Sciences, a leader in large and fast-growing cancer screening and precision | Exact Sciences. https://www.exactsciences.com/newsroom/press-releases/abbott-to-acquire-exact-sciences-a-leader-in-large-and-fast-growing-cancer-screening-and-precision |
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We plan to rely on third-party logistics providers to assemble and distribute at-home test kits rather than manufacturing or distributing them internally. This approach is intended to limit capital investment but subjects us to risks related to quality control, supply chain disruptions, and contractual performance by third-party vendors.
We also intend to maintain a digital ordering and telemedicine infrastructure to support test fulfillment, genetic counseling, and provider follow-up. These systems are designed to support scalable at-home testing as part of a clinically informed and institutionally enabled distribution model rather than consumer-led demand generation.
Laboratory Partnerships
As part of our commercialization strategy, we plan to partner with independent CLIA-certified, CAP-accredited laboratories that have established physician sales channels and reimbursement relationships.
Clinical samples are currently processed by GIA, a CLIA-certified laboratory with whom we have an existing agreement. Because operation through a CLIA and CAP-accredited laboratory is a crucial requirement for commercialization, we are prioritizing the expansion of this capacity and securing additional certifications as forthcoming milestones.
Under this model, these laboratories may perform the Revealia™ Breast test as a Laboratory Developed Test (LDT) using our proprietary algorithm, or they may elect to send patient samples to our affiliated laboratory for testing and reporting. This channel is intended to broaden physician adoption and create early opportunities for reimbursement.
Awareness and Community Engagement
To sustain adoption across both consumer and physician channels, we intend to engage medical advisors, patient advocacy groups, and professional organizations to provide education and promote awareness of our tests. We may also explore partnerships with telehealth and digital health marketplaces to further extend access. In addition, we may implement digital engagement tools, such as waitlists or educational newsletters, to capture prospective customers not yet ready to purchase, thereby supporting long-term adoption.
Reimbursement Pathway
Over time, our commercialization strategy will increasingly depend on securing reimbursement from commercial insurers and public payors once sufficient validation data are available and published in peer-reviewed journals. We believe coverage and reimbursement will be a key driver of long-term adoption.
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Economic data illustrate the cost implications of cancer stage at diagnosis. One study found that average costs per patient in the year following diagnosis were approximately $60,000 for stage 0 breast cancer, compared to nearly $135,000 for stage IV disease13, as illustrated in the graph below. These differences reflect the higher resource utilization and treatment intensity associated with late-stage disease. If validated, the ability of our test to help shift detection toward earlier stages could align with payer incentives to manage costs while improving patient outcomes.
| 13 | Mariotto, A. B., Yabroff, K. R., Shao, Y., Feuer, E. J., & Brown, M. L. (2011, January 19). Projections of the cost of cancer care in the United States: 2010-2020. Journal of the National Cancer Institute. https://pmc.ncbi.nlm.nih.gov/articles/PMC3107566 |
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Accordingly, the long-term success of our commercialization strategy will depend on achieving reimbursement coverage, publishing peer-reviewed data, and expanding our laboratory network. We intend to pursue Clinical Laboratory Improvement Amendments (CLIA) certification and College of American Pathologists (CAP) accreditation for partner laboratories, while continuing to build awareness through digital marketing, educational outreach, and physician engagement.
All commercialization activities are expected to take place in CLIA-certified, CAP-accredited laboratories. Our tests have not been cleared or approved by the U.S. Food and Drug Administration (FDA). See “Government Regulation” and “Risk Factors—Risks Related to Commercialization.”
Business Model and Revenue Streams
Our anticipated revenue will be derived from the commercialization of our Laboratory Developed Tests (LDTs), beginning with the Revealia™ Breast test. We expect to employ a multi-channel model that prioritizes business-to-business-to-consumer (B2B2C) relationships, partnerships with employers, captive insurers, and, over time, coverage and reimbursement from commercial and public payors.
Our commercialization strategy is designed to support a phased and risk-managed launch, leveraging CLIA-certified, CAP-accredited laboratory oversight under the current laboratory developed test (LDT) regulatory framework. We are targeting an initial commercial launch beginning in the second quarter of 2026. The planned multi-channel approach is intended to diversify revenue sources and mitigate customer acquisition risk by engaging multiple institutionally enabled access pathways. In addition, the ability for at-home sample collection is expected to facilitate real-world data generation that may support future payer engagement and coverage discussions.
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Consumer-Paid Testing
In the near term, we may offer collection kits on a consumer-paid basis in circumstances where a test is ordered through institutionally enabled pathways, including our business-to-business-to-consumer (B2B2C) channels or other clinically affiliated access points. Under this model, a healthcare provider or other affiliated channel would facilitate access to the test, and the patient would pay out-of-pocket at the time of order in cases where insurance coverage or reimbursement is not available. Each kit will include sample collection materials and return shipping to a CLIA-certified, CAP-accredited laboratory for analysis.
Revenue may be generated on a per-test basis, with patients paying out-of-pocket at the time of order in cases where insurance coverage is not available. Payment is expected to cover the collection kit, laboratory analysis, and associated reporting services. We also plan to provide access to certified genetic counselors to support patient understanding of test results, which may be included in the purchase price. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations” for additional information regarding revenue recognition.
Laboratory Partnerships
In parallel, we expect to establish agreements with independent CLIA-certified, CAP-accredited laboratories that already maintain physician sales channels and insurance reimbursement relationships. Under this model, revenue may be generated either through per-test licensing of our proprietary algorithms, allowing partner laboratories to generate test results locally, or through testing services performed in our affiliated laboratory on samples referred by partner laboratories. This channel is intended to support clinically affiliated adoption and payer engagement within our broader B2B2C commercialization strategy. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations” for a discussion of cost considerations related to this model.
Clinically Affiliated and Institutional Distribution
Our business-to-business-to-consumer (B2B2C) strategy emphasizes institutional and clinically affiliated distribution through healthcare providers and affiliated organizations that serve as trusted access points for patients. Under this model, access to the test is expected to be facilitated through clinically affiliated. Patients may be introduced to the test in connection with an in-person clinical encounter, a telemedicine consultation, or other provider-enabled access point, depending on the specific distribution channel.
In this model, hospitals, cancer centers, physician networks, or other clinically affiliated partners introduce the test within established care pathways by incorporating it into existing clinical workflows, referral processes, or provider-supported ordering systems, supporting adoption at scale through clinical validation and workflow integration. We do not currently intend for the test to be purchased directly by consumers at retail pharmacies or stores without clinical or institutional involvement
This approach positions the test as a clinically informed decision-support tool rather than a consumer wellness product. Consistent with this strategy, we expect digital ordering and telemedicine capabilities to support provider-facilitated ordering, patient education, and follow-up.
Operationalizing Institutional Scale
Financially, this model is expected to transform revenue from transactional and unpredictable to contracted and recurring. Instead of managing thousands of individual customer relationships, the sales motion targets high-volume organizational accounts—such as accredited cancer programs or large specialty clinics—where a single Master Service Agreement (MSA) can unlock access to thousands of eligible patients annually. This structure is aimed at significantly lowering the marginal cost of customer acquisition (CAC) over time and builds a defensive market “moat” through deep integration into clinical workflows and electronic health records, ensuring long-term usage driven by medical guidelines rather than consumer trends.
Additional Commercial Pathways
We may also pursue white-label arrangements with commercial laboratories and collaborations with clinically affiliated or institutionally enabled health platforms. Under these models, our tests could be offered under partner branding while utilizing our proprietary biomarker panel and algorithms. These additional pathways are designed to diversify revenue opportunities and extend market reach in a manner consistent with our B2B2C distribution strategy.
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Third-Party Reimbursement
Over time, we plan to pursue coverage and reimbursement from captive insurers, commercial insurers and public health programs. We believe reimbursement will be a critical driver of adoption among physicians and patients. Until reimbursement is secured, test adoption may be constrained by patients’ willingness and ability to pay out-of-pocket. We expect test volumes and revenue to increase materially if and when coverage is obtained, although reimbursement rates may be lower than out-of-pocket pricing. Accordingly, the timing and scope of reimbursement approvals will significantly influence our revenue trajectory. See “Risk Factors—Risks Related to Reimbursement and Coverage.”
Future Opportunities
Beyond oncology, our technology platform may enable the development of additional LDTs for other inflammation-driven diseases. If validated, these products would follow the same revenue model described above. We may also explore opportunities to license our biomarker panels and machine-learning algorithms for use in pharmaceutical research and development. Longer-term, we intend to develop a proprietary mRNA Inflammatory Index™ database, which may have applications in pharmaceutical R&D and drug development programs, creating potential partnership and licensing opportunities. We have not entered into any such agreements to date.
All testing is intended to be conducted in CLIA-certified, CAP-accredited laboratories. Our tests have not been cleared or approved by the U.S. Food and Drug Administration (FDA). See “Government Regulation.”
Intellectual Property
Our ability to compete effectively depends in part on protecting the proprietary aspects of our technology. Because many of our competitors are larger and better funded, we rely on intellectual property rights to safeguard our diagnostic methods, machine-learning algorithms, and branding, and to create barriers to entry in a competitive market.
We seek to protect our technology through a combination of patents, trade secrets, trademarks, and proprietary algorithms. Our intellectual property portfolio includes two patent families covering diagnostic tests using mRNA for identifying breast, bladder, colon, and other cancers, with filings in the United States, Europe, Australia, New Zealand, Canada, Israel, India, and South Korea. A second family is still in the international stage and is expected to be published in September 2025. These applications include both composition-of-matter and method claims related to our biomarker panels. If granted, our earliest patents are expected to expire in 2039, subject to any patent term extensions. As of the date of this annual report, all of our patent applications are pending.
We have filed US provisional and international patent applications, including PCT Patent Application PCT/US202/064751, which covers our proprietary 48-gene inflammatory mRNA biomarker panel and its diagnostic use with buccal (cheek) swab-derived samples forming the basis of the Revealia™ Breast assay. This application claims the benefit of (a) U.S. Provisional Application No. 63/376,400, filed September 20, 2022 and (b) U.S. Provisional Application No. 63/500,901, filed May 8, 2023.
Our patent portfolio also includes applications directed to methods and systems for buccal swab sample collection, sample processing, and integration of mRNA data with our biomarker panels for diagnostic analysis.
In addition, we have filed provisional patent applications covering improvements to buccal swab sampling technologies and related collection protocols intended to enhance the performance of mRNA-based molecular testing.
As with all early-stage companies in our field, the scope and validity of our intellectual property rights are subject to uncertainty. Patent applications may not issue, issued patents may be challenged, circumvented, or invalidated by third parties, and the claims of any patents that do issue may not provide sufficient protection against competitors.
We also rely on confidential know-how and proprietary software, including machine-learning algorithms used to analyze mRNA expression data. We take measures to protect these trade secrets through confidentiality agreements, internal policies, and technical safeguards.
We use the trademark Revealia™ in connection with our products and have filed applications for its protection in the United States and select foreign jurisdictions.
We do not currently rely on any material in-licensed intellectual property from third parties.
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Regulatory Environment
Our operations are subject to extensive regulation at the federal, state, and international levels. Compliance with these frameworks is essential to our ability to develop, commercialize, and obtain reimbursement for our products. The principal areas of regulation include laboratory oversight, reimbursement-related rules, data protection, and international frameworks.
Laboratory-Developed Tests (LDTs)
We intend to commercialize our assays as Laboratory-Developed Tests (LDTs) performed in Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited laboratories. The Food and Drug Administration (FDA) has historically exercised enforcement discretion with respect to most LDTs, meaning such tests are generally not subject to premarket review or approval. However, the FDA has asserted authority over LDTs, and legislative or regulatory changes could result in heightened oversight, including requirements for premarket clearance or approval, post-market surveillance, or quality system compliance.
As commonly understood, LDT status contemplates development and use within a single CLIA laboratory certificate and may be affected if test components or performance are distributed across multiple sites or third parties. In addition, ordering and availability may be limited by state law and payer policy and generally require a valid order from an authorized healthcare professional rather than direct-to-consumer access. Changes in federal or state requirements, or in FDA enforcement policies regarding LDTs, could require us to modify our operating model or seek additional clearances. See “Risk Factors–Risks Related to Government Regulation.”
CLIA and CAP Oversight
All laboratories performing our tests must be certified under CLIA, which establishes quality standards for laboratory testing to ensure accuracy, reliability, and timeliness of patient results. In addition, we intend for our own and partner laboratories to be accredited by CAP, which imposes more stringent requirements than CLIA in certain areas. Operating through a CLIA and CAP-accredited laboratory is essential to our commercialization strategy, and securing and maintaining this accreditation is a forthcoming milestone for our business. Failure by any laboratory performing our tests to maintain CLIA certification or CAP accreditation could cause disruption in our business.
Reimbursement-Related Regulations
If we seek reimbursement from government payors such as Medicare or Medicaid, or from commercial insurers, our business will be subject to additional regulation by the Centers for Medicare & Medicaid Services (CMS) and comparable state agencies. In connection with reimbursement, we will also be subject to various federal and state healthcare fraud and abuse laws, including the federal Anti-Kickback Statute, the Stark Law, the False Claims Act, and similar laws that impose liability for improper billing, payments, or inducements related to healthcare services. Compliance with these rules will be critical to our ability to obtain and retain coverage and reimbursement for our tests.
Patient Privacy and Data Protection
We are subject to federal and state laws governing the privacy and security of health information, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act. HIPAA and HITECH establish standards for the use, disclosure, and safeguarding of protected health information and impose breach notification requirements. At the state level, various laws impose additional requirements, such as the California Consumer Privacy Act (CCPA). If we expand to collect or process patient data outside the United States, we will become subject to international data protection laws, including the European Union’s General Data Protection Regulation (GDPR) and the United Kingdom’s Data Protection Act. These frameworks impose strict requirements on the collection, use, and transfer of personal data, including genetic data, and provide for significant penalties in the event of noncompliance.
International Regulation
If we expand our operations internationally, we will become subject to regulation by agencies outside the United States, such as the European Medicines Agency (EMA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), and comparable national authorities in other jurisdictions. These agencies regulate the development, commercialization, and marketing of diagnostic tests and may impose requirements that differ materially from those in the United States.
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Other Healthcare and Environmental Regulation
Our operations are subject to additional federal and state healthcare regulations, including laws relating to physician referrals, clinical research, and informed consent. In addition, we must comply with federal, state, and local laws relating to the disposal of medical and hazardous waste generated in the course of our laboratory operations. Failure to comply with these requirements could result in civil or criminal penalties, reputational harm, or restrictions on our operations.
Summary
The regulatory landscape governing LDTs and genetic testing continues to evolve. Changes in the interpretation or enforcement of existing laws, the adoption of new laws or regulations, or the expansion of existing regulatory requirements could materially impact our business. See “Risk Factors—Risks Related to Government Regulation.”
Competitive Environment
The market for cancer diagnostics is highly competitive and rapidly evolving. In addition to specialty diagnostics companies, we may also face competition from large clinical laboratories, academic research institutions, and technology companies that could develop or commercialize cancer diagnostic tests.
Many of these entities have significantly greater financial, technical, and commercial resources than we do, as well as established relationships with healthcare providers and payors. Indirect competition may also arise from consumer genetic testing companies, such as 23andMe, which have established brands and direct-to-consumer distribution channels, though their products are not currently designed for cancer screening.
Key competitors in oncology diagnostics include:
| ● | Natera, Inc., a global genetic testing company whose flagship product Signatera™ is a personalized circulating tumor DNA assay used for minimal residual disease detection and monitoring. Natera competes on the basis of clinical validation, sensitivity, regulatory engagement, and established adoption among oncologists. |
| ● | Guardant Health, Inc., which markets the FDA-approved Shield™ blood-based assay for colorectal cancer screening in average-risk adults. Guardant competes through regulatory clearance, established laboratory infrastructure, and broad market access. |
| ● | Exai Bio, Inc., a private company developing an oncRNA + AI–based early detection platform across multiple cancers. While their tests remain in validation, Exai competes on RNA biomarker innovation, breadth of coverage, and AI analytics. |
| ● | Exact Sciences Corporation, which offers Cologuard Plus™, an FDA-approved stool-based DNA assay for colorectal cancer screening, and Oncotype DX® tissue-based genomic tests. Cologuard Plus™ requires collection of a stool sample for laboratory analysis and is intended for colorectal cancer screening rather than multi-cancer or breast cancer detection. Exact Sciences competes through regulatory approvals, reimbursement coverage, and large-scale commercial infrastructure. |
| ● | GRAIL, Inc., developer of the Galleri® blood-based circulating tumor DNA (cfDNA) assay for multi-cancer early detection, offered as an LDT in the United States. Galleri® requires a clinical blood draw and analyzes tumor-derived DNA fragments, with publicly reported sensitivity varying by cancer type and generally lower performance in early-stage disease. GRAIL competes through its broad multi-cancer focus, financial resources, and health-system collaborations. |
| ● | Freenome Holdings, Inc., a private company pursuing multiomics blood tests for colorectal cancer screening. Freenome competes based on its multiomics approach, investor backing, and large clinical studies, though it does not yet have FDA approval. |
| ● | DELFI Diagnostics, which offers the FirstLook Lung cfDNA fragmentomics test as an LDT for early lung cancer detection. DELFI competes based on fragmentomics methods, machine-learning analytics, and clinical validation data. |
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| ● | Avantect (ClearNote Health), which markets a cfDNA-based assay for pancreatic cancer in high-risk populations. Avantect competes on its epigenomic innovation and specificity, though it faces risks related to regulatory clearance and broad population applicability. |
The comparative information presented in the table above is derived from publicly available clinical studies, regulatory disclosures, and company-published performance data.14,15,16
Limitations of Existing Cancer Screening Approaches
Current cancer screening methods vary significantly by disease area and are often limited by access constraints, procedural complexity, and biological sensitivity, particularly at earlier stages of disease. For certain cancers, such as breast and ovarian cancer, existing screening approaches may be invasive, inconsistently adopted, or unable to reliably identify disease at an early stage.
Imaging-based screening methods may fail to detect certain early-stage cancers, including so-called interval cancers that present clinically between routine screening exams.17
Breast cancer screening modalities such as mammography, ultrasound, and magnetic resonance imaging are performed in clinical imaging settings and require specialized equipment and trained radiology personnel, a widely recognized operational characteristic of imaging-based screening programs, as reflected in clinical practice guidelines.
Breast cancer screening participation varies widely across countries, and adherence remains low in many regions globally, reflecting both cross-country differences in screening uptake and structural constraints on the implementation of population-based mammography programs18,19
| 14 | Natasha J. Pyzocha, DO, FAWM, FAAFP, Galleri Test for the Detection of Cancer, American Family Physician, Vol. 106, No. 4, at 459–460 (2022), available at https://www.aafp.org/pubs/afp/issues/2022/1000/diagnostic-tests-galleri-test-cancer.html |
| 15 | Eric A. Klein et al., Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set, Annals of Oncology, Vol. 32, No. 9, at 1167–1177 (2021), available via ScienceDirect at https://www.sciencedirect.com/science/article/pii/S0923753421020469 |
| 15b | B. D. Nicholson et al., Multi-cancer early detection test in symptomatic patients referred for cancer investigation in England and Wales (SYMPLIFY): a large-scale, observational cohort study, Lancet Oncology, Volume 24, Issue 7, Pages 733-743 (2023). https://www.thelancet.com/article/S1470-2045(23)00277-2/fulltext |
| 16 | Exact Sciences Corporation, Accuracy, Sensitivity, and Specificity of Cologuard®, Cologuard® for Healthcare Professionals (reporting that “94% of adults with early-stage CRC tested positive” for Stage I–II colorectal cancer), available at https://www.cologuardhcp.com/about/accuracy-sensitivity-specificity |
| 17 | US Preventive Services Taskforce. (2024, April 30). Breast cancer: Screening. Recommendation: Breast Cancer: Screening | United States Preventive Services Taskforce. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/breast-cancer-screening |
| 18 | Cancer screening: Health at a glance 2025 | OECD. (n.d.). https://www.oecd.org/en/publications/2025/11/health-at-a-glance-2025_a894f72e/full-report/cancer-screening_a3f047dd.html |
| 19 | Chestnov, O., & Mendis, S. (2014, January 1). WHO position paper on mammography screening. Geneva; World Health Organization. |
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For ovarian cancer, there is currently no approved or recommended routine population-level screening test, as described in the U.S. Preventive Services Task Force’s Ovarian Cancer: Screening recommendation statement.20 CA-125 testing lacks sufficient sensitivity and specificity for early-stage ovarian cancer and is frequently within the normal range in early disease, as described in the National Cancer Institute’s PDQ® Ovarian Cancer Screening summary.21, 22 Transvaginal ultrasound has not demonstrated reliable detection of early-stage ovarian tumors when used for screening and has not been shown to reduce ovarian cancer mortality, as reported in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) final results23. More than 70% of ovarian cancers are diagnosed at advanced stages in population-level data (regional or distant disease), as reflected in stage-at-diagnosis data reported by the American Cancer Society and the National Cancer Institute’s SEER program24.
The following summary highlights key limitations of commonly used screening methods for breast and ovarian cancer and outlines the intended attributes of the Revealia™ platform.
| 20 | US Preventive Services Taskforce. (2018, February 13). Ovarian cancer: Screening. Recommendation: Ovarian Cancer: Screening | United States Preventive Services Taskforce. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/ovarian-cancer-screening |
| 21 | Ovarian, fallopian tube, & primary peritoneal cancers screening (PDQ®). Ovarian, Fallopian Tube, & Primary Peritoneal Cancers Screening (PDQ®) - NCI. (n.d.). https://www.cancer.gov/types/ovarian/hp/ovarian-screening-pdq |
| 22 | Gori J;Castaño R;Toziano M;Häbich D;Staringer J;De Quirós DG;Felci N; (n.d.). Intraperitoneal hyperthermic chemotherapy in ovarian cancer. International journal of gynecological cancer : official journal of the International Gynecological Cancer Society. https://pubmed.ncbi.nlm.nih.gov/15823105/ |
| 23 | Ovarian cancer population screening and mortality after long-term follow-up in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomized controlled trial. Menon, Usha et al. The Lancet, Volume 397, Issue 10290, 2182 – 2193 |
| 24 | American Cancer Society, Ovarian Cancer: Early Detection, Diagnosis, and Staging, available at https://www.cancer.org/cancer/types/ovarian-cancer/detection-diagnosis-staging.html; see also National Cancer Institute, SEER Program, Cancer Stat Facts: Ovarian Cancer (reporting that approximately 74% of cases are diagnosed at regional or distant stages), available at https://seer.cancer.gov/statfacts/html/ovary.html |
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Comparison to Existing Breast Cancer Screening Modalities
Current breast cancer screening relies on a combination of imaging-based modalities, including mammography, ultrasound, and magnetic resonance imaging (MRI), each of which has different clinical use cases, access requirements, and limitations. The following table summarizes key characteristics of these commonly used screening methods compared to the Revealia™ Breast test, based on publicly available information and the intended use of each modality.
| ● | Continued metadata analysis across the breast cancer cohort |
| ● |
Additional insights shared as validation progresses |
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Reported sensitivity and related screening performance characteristics for mammography were drawn from Susan G. Komen’s “Accuracy of Mammograms” overview25 Sensitivity characteristics for breast ultrasound in dense-breast and related screening contexts were drawn from Sardanelli et al.’s 2024 review article, “The paradox of MRI for breast cancer screening: high-risk and dense breasts, available evidence and current practice”26 Sensitivity characteristics for breast MRI, including MRI performance as an adjunct to mammography in higher-risk screening populations, were drawn from Saslow et al., “American Cancer Society Guidelines for Breast Screening with MRI as an Adjunct to Mammography”27
Other comparative attributes reflected in the table, including the biology measured (structural imaging versus molecular signal), sample type, collection setting, and suitability for at-home or retail-enabled access, are based on the intended use and operational requirements of each modality and on the design goals of the Revealia™ Breast test as described elsewhere in this section.
Ovarian Cancer Screening Landscape
Unlike breast cancer, there is currently no widely accepted or approved population-level screening pathway for ovarian cancer, as described by the Centers for Disease Control and Prevention in its “Screening for Ovarian Cancer” overview28. Commonly used clinical tools, such as CA-125 blood testing and transvaginal ultrasound, have not demonstrated effectiveness in reducing ovarian cancer mortality when used for screening and are generally applied only in symptomatic or high-risk populations, as reflected in guidance from the Centers for Disease Control and Prevention and the National Cancer Institute. Separately, ovarian cancer is often diagnosed at advanced stages, with the majority of cases identified at stage III or stage IV, when treatment options are more limited and outcomes are poorer, as described in the National Cancer Institute’s PDQ® materials and published epidemiologic analyses.
The following table summarizes key characteristics of existing clinical approaches compared to the intended screening role of the Revealia™ ovarian assay under development, based on publicly available data and the design goals of our platform.
| CA-125 | Transvaginal Ultrasound | Revealia Ovarian (in development) | |
| Early detection capability |
● Poor sensitivity and specificity for early-stage ovarian cancer. ● Many early cancers have normal CA-125. |
● Can detect masses but did not reduce mortality because it rarely finds ovarian cancer early enough to change outcomes. | ● Aims to detect mRNA expression patterns associated with ovarian cancer and systemic inflammatory response, before tumors are visible on imaging. |
| Biology measured | ● Serum protein marker (CA-125). | ● Structural anatomy only | ● Detects molecular signals that may appear earlier in the ovarian cancer process, before imaging can see a mass. |
| Sample type | ● Blood draw | ● Ultrasound exam via transvaginal probe | ● Non-invasive cheek swab |
| Convenience/Collection | ● Requires clinic or lab visit, venipuncture. | ● Invasive, requires specialist and equipment |
● Simple at-home or in-store swab ● No imaging or blood draw |
| At-home/Retail suitability | ● Not designed for mass retail or home collection. | ● Only feasible in clinical settings | ● Fully suitable; retail-ready |
| 25 | Accuracy of mammograms. Susan G. Komen®. (2025, March 17). https://www.komen.org/breast-cancer/screening/mammography/accuracy/ |
| 26 | Sardanelli, F., Magni, V., Rossini, G. et al. The paradox of MRI for breast cancer screening: high-risk and dense breasts—available evidence and current practice. Insights Imaging 15, 96 (2024). https://doi.org/10.1186/s13244-024-01653-4 |
| 27 | Saslow, D., Boetes, C., Burke, W., Harms, S., Leach, M.O., Lehman, C.D., Morris, E., Pisano, E., Schnall, M., Sener, S., Smith, R.A., Warner, E., Yaffe, M., Andrews, K.S., Russell, C.A. and for the American Cancer Society Breast Cancer Advisory Group (2007), American Cancer Society Guidelines for Breast Screening with MRI as an Adjunct to Mammography†. CA: A Cancer Journal for Clinicians, 57: 75-89. https://doi.org/10.3322/canjclin.57.2.75 |
| 28 | PDQ® Screening and Prevention Editorial Board. PDQ Ovarian, Fallopian Tube, and Primary Peritoneal Cancers Screening. Bethesda, MD: National Cancer Institute. Updated <MM/DD/YYYY>. Available at: https://www.cancer.gov/types/ovarian/hp/ovarian-screening-pdq. |
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Comparative Positioning
Based on publicly available information, we believe that our cheek-swab-based assay offers a more convenient sample type than existing blood, stool, or tear-based tests. Comparative profiles suggest that this approach may provide advantages in accessibility and patient compliance, particularly for individuals who prefer at-home self-collection.
Competitive Basis
We believe the principal factors of competition in our industry include:
| ● | Clinical accuracy and validation (sensitivity, specificity, predictive value) |
| ● | Convenience and accessibility of testing (sample type, at-home vs. clinical collection) |
| ● | Regulatory clearance and compliance frameworks |
| ● | Reimbursement coverage and cost-effectiveness |
| ● | Brand reputation and physician adoption |
Our Positioning
Unlike DNA-based testing approaches, which typically rely on detecting inherited variants or tumor-derived DNA fragments, our mRNA-based approach is designed to assess dynamic gene-expression signals associated with active disease biology. By analyzing inflammatory and immune-response mRNA patterns, our platform is intended to capture biologically relevant signals that may arise earlier in disease progression.
In addition, our use of a non-invasive cheek swab collection method supports at-home self-collection and broader accessibility compared to blood- or procedure-based testing. Combined with a proprietary biomarker panel and machine-learning algorithms, we believe this approach differentiates our platform within the cancer diagnostics landscape. However, many competitors have greater resources, infrastructure, and established commercial relationships, and we may not be able to compete successfully in all areas.
Employees
Currently, we employ a total of five individuals. We rely on consultants and independent contractors for specialized services such as bioinformatics, regulatory compliance, and clinical trial management. None of our employees are represented by a labor union or subject to a collective bargaining agreement.
Our future success depends in large part on our ability to attract, develop, and retain highly qualified personnel in scientific, technical, and business roles. To date, we believe we have been successful in recruiting and retaining talent due to our mission-driven culture, collaborative environment, and opportunities to contribute to the development of innovative genomic diagnostics. We intend to expand our workforce as we progress toward the commercialization of the Revealia™ Breast test and the development of additional assays.
Corporate Information
The Company was originally organized as a Kentucky corporation on February 11, 1988. On February 8, 2006, we formed a wholly owned subsidiary, Ludwig Enterprises, Inc., a Nevada corporation. On March 28, 2006, Ludwig Enterprises, Inc., our Kentucky corporation, merged with and into Ludwig Enterprises, Inc., our Nevada corporation, with the Company, Ludwig Enterprises, Inc., the Nevada corporation, being the surviving entity.
Our principal executive offices, and our subsidiaries, are located at 8950 SW 74th Ct, Ste 2201-A149, Miami, FL 33156; our telephone number is (786) 363-0166; our corporate website is located at www.ludwigent.com. No information found on, or connected to, the Company’s website is incorporated by reference into, and you must not consider the information to a part of, this Annual Report
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Item 1A. Risk Factors
An investment in our shares of Common Stock involves significant risks. Before making an investment in our shares of Common Stock, you should carefully consider the risks and uncertainties discussed below under “Information Regarding Forward-Looking Statements,” and the specific risks set forth herein. Any of the following risks could have a material adverse effect on our business, financial condition and results of operations. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially and adversely affect our business, prospects, financial condition, results of operations, cash flows and ability to pay dividends. In any such case, the market price of our shares of Common Stock could decline, and you may lose all or part of your investment.
Risks Related to the Company
We are an early-stage genomics technology and health related Company without any products or services currently available for sale and we may not be able to successfully develop or bring products or services to market.
We have several product and service candidates, including our proprietary mRNA genetic program that we intend to begin marketing by the second quarter of 2026; however, there is no assurance that we will succeed in bringing any of our product and service candidates to market or that such product candidates, or any of our other operations, will generate any revenue. If we cannot develop a marketable product or generate sufficient revenues, we may be required to suspend or cease operations.
Our business operations have only a limited history upon which an evaluation of our prospects and future performance can be made. The Company’s operations are subject to all business risks associated with development stage enterprises. The likelihood of the Company’s success must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered in connection with the establishment and expansion of a business, operation in a competitive industry and the necessary continued development of advertising and other marketing strategies. We believe it is likely that we will continue to sustain losses throughout the next twelve months. We cannot assure you that we will ever operate profitably.
Additionally, we have a limited operating history, and as a result our historical financial and other operating data may be of limited value in estimating future operating revenue, revenue sources and expenses. Our budgeted expense levels are based in part on our expectations concerning future revenue and future revenue sources. The amount and sources of these revenues will depend on the success of our ability to establish the commercial viability of our new products, to sustain our marketing efforts, the perception of our products by customers and users, and other factors that are difficult to forecast accurately.
Our internal controls may be inadequate, which could cause our financial reporting to be unreliable and lead to misinformation being disseminated to the public.
Our management is responsible for establishing and maintaining adequate internal control over our financial reporting. As defined in Exchange Act Rule 13a 15(f) (the “Exchange Act”), internal control over financial reporting is a process designed by, or under the supervision of, the principal executive and principal financial officer and effected by the Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
| ● | pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company; |
| ● | provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and/or directors of the Company; and |
| ● | provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements. |
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Our internal controls may be inadequate or ineffective, which could cause financial reporting to be unreliable and lead to misinformation being disseminated to the public. Investors relying upon this misinformation may make an uninformed investment decision.
Failure to achieve and maintain an effective internal control environment could cause us to face regulatory action and also cause investors to lose confidence in our reported financial information, either of which could have a material adverse effect on the Company’s business, financial condition, results of operations and future prospects.
However, our auditors will not be required to formally attest to the effectiveness of our internal control over financial reporting pursuant to Section 404 until we are no longer an EGC if we take advantage of the exemptions available to us through the JOBS Act.
Our principal shareholders have significant voting power and may take actions that may not be in the best interests of our other shareholders
Our principal shareholders hold in aggregate approximately 77% of our shares. We are not considered a “controlled company” under corporate governance rules as we do not currently expect that more than 50% of our voting power will be held by an individual, a group or another company, these shareholders, however, if they act together, will be able to control the management and affairs of our company and most matters requiring shareholder approval, including the election of directors and approval of significant corporate transactions. The interests of these shareholders may not be the same as or may even conflict with your interests. For example, these shareholders could attempt to delay or prevent a change in control of us, even if such change in control would benefit our other shareholders, which could deprive our shareholders of an opportunity to receive a premium for their shares of Common Stock as part of a sale of us or our assets, and might affect the prevailing market price of our Common Stock due to investors’ perceptions that conflicts of interest may exist or arise. As a result, this concentration of ownership may not be in the best interests of our other shareholders.
The report of our independent auditors on our financial statements for the year ended December 31, 2025 and 2024, indicates uncertainty concerning our ability to continue as a going concern and this may impair our ability to raise capital to fund our business.
The report of our independent auditors indicates uncertainty concerning our ability to continue as a going concern and this may impair our ability to raise capital to fund our business. In its opinion on our financial statements for the years ended December 31, 2025 and 2024, our independent auditors raised substantial doubt about our ability to continue as a going concern. We cannot assure you that this will not impair our ability to raise capital on attractive terms. Additionally, we cannot assure you that we will ever achieve significant revenues and therefore remain a going concern. Our financial statements do not include any adjustments that might result from the outcome of this uncertainty.
The obtainment of additional financing, the successful development of our contemplated plan of operations, and its transition, ultimately, to the attainment of profitable operations are necessary for us to continue operations. These conditions and the ability to successfully resolve these factors over the next twelve months raise substantial doubt about our ability to continue as a going concern.
We have incurred significant losses in prior periods, and losses in the future could cause the quoted price of our Common Stock to decline or have a material adverse effect on our financial condition, our ability to pay our debts as they become due, and on our cash flows.
To date, we have not generated revenues from our operations, and we have incurred significant losses in prior periods. For the years ended December 31, 2025 and 2024, we incurred a net loss of $2,236,433 and $3,016,884, respectively, and, as of such dates, we had an accumulated deficit of $9,495,799 and $7,259,366 respectively.
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The time required for us to become profitable is highly uncertain, and we cannot assure you that we will achieve or sustain profitability or generate sufficient cash flow from operations to meet our planned capital expenditures, working capital and debt service requirements. If required, our ability to obtain additional financing from other sources also depends on many factors beyond our control, including the state of the capital markets and the prospects for our business. The necessary additional financing may not be available to us or may be available only on terms that would result in further dilution to the current owners of our Common Stock. We expect we will require significant capital in connection with our efforts, and we will be required to continue to make significant investments to further develop and expand our business. In particular, we expect to continue to expend substantial financial and other resources on further research studies, marketing and advertising as part of our strategy to develop and increase our business-to-consumer (“B2C”) channels, as well as on research and development activities regarding our proprietary mRNA genetic methodologies. The sales, marketing and advertising expenses that we will incur will typically be expensed immediately. In addition, to the extent that our business ramps up as we expect, we will need to increase our headcount significantly in the coming years.
We intend to seek interim short-term financing to assure full legal compliance with our Securities and Exchange Commission (“SEC”) filings, and to bring on the necessary personnel to begin our future development activities. Our working capital needs will be met largely from the sale of debt and public equity securities until such time that funds provided by operations, if ever, are sufficient to fund working capital requirements. The accompanying financial statements do not include any adjustments relating to the recoverability or classification of recorded assets and liabilities that might result should the Company be unable to continue as a going concern.
We will require additional capital to fund our operations and if we do not obtain additional capital, we may be required to scale back, delay or cease our operations.
Our business does not presently generate the cash needed to finance our current and anticipated operations and we will need to obtain additional financing to finance our operations, until such time that we are able to conduct profitable revenue generating activities.
Through the date of this annual report, we have obtained approximately $3,000,000 in loans to meet our ongoing expenses, including professional fees and day-to-day operating expenses. We cannot assure you that adequate financing will be available on acceptable terms, if at all. Our failure to raise additional financing in a timely manner would adversely affect our ability to pursue our business plan and could cause us to delay launching our product and our proposed business plan.
We will need additional capital. If additional capital is not available or is available at unattractive terms, we may be forced to delay, reduce the scope of or eliminate our research and development programs, reduce our commercialization efforts or curtail our operations.
To develop and bring our product candidates to market, we must commit substantial resources to costly and time-consuming research, clinical and observational staging studies and marketing activities. We will need to raise additional funding to fund further research and development with respect to our product candidates. We will also need to raise additional funding sooner if our business or operations change in a manner that consumes available resources more rapidly than we anticipate. Our requirements for additional capital will depend on many factors, including:
| ● | the time and expense for clinical and observational staging studies for our product candidates; | |
| ● | the time and costs involved in obtaining regulatory approval for our product candidates, if needed; |
| ● | costs associated with protecting our intellectual property rights; |
| ● | successful commercialization of our product candidates; |
| ● | development of marketing and sales capabilities; |
| ● | payments received under current and future collaborative agreements, if any; and |
| ● | market acceptance of our products. |
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To the extent we raise additional capital through the sale of equity securities, the issuance of those securities could result in dilution to our shareholders. In addition, if we obtain debt financing, a substantial portion of our operating cash flow may be dedicated to the payment of principal and interest on such indebtedness, thus limiting funds available for our business activities. If adequate funds are not available, we may be required to delay, reduce the scope of or eliminate our research and development programs, reduce our commercialization efforts or curtail our operations. In addition, we may be required to obtain funds through arrangements with collaborative partners or others that may require us to relinquish rights to technologies, product candidates or products that we would otherwise seek to develop or commercialize ourselves or license rights to technologies, product candidates or products on terms that are less favorable to us than might otherwise be available.
We will require substantial additional funds to support our research and development activities, and the anticipated costs of clinical and observational staging studies, possible regulatory approvals and eventual commercialization. Such additional sources of financing may not be available on favorable terms, if at all. If we do not succeed in raising additional funds on acceptable terms, we may be unable to commence or complete clinical and observational staging studies or, if needed, obtain approval of any product candidates from the FDA and other regulatory authorities. In addition, we could be forced to discontinue product development, forego sales and marketing efforts and forego attractive business opportunities. Any additional sources of financing will likely involve the issuance of our equity securities, which will have a dilutive effect on our shareholders.
We may not be successful in raising the additional funds needed to fund our business plan. If we are not able to raise sufficient capital in the near future, our continued operations will be in jeopardy and we may be forced to cease operations and sell or otherwise transfer all or substantially all of our remaining assets.
We do not have funds sufficient to conduct our proposed clinical studies to completion.
We will need to raise additional funds to complete them. In the event we are unable to raise additional funds this will have an adverse effect on our business and our ability to bring products to market.
The Company has product candidates with very complex and different sales and marketing channels, the development of which will put significant burdens on us and which we may not be able to develop as effectively as competitors.
We will have very different sales and marketing channels if the products in our pipeline are to reach customers in their respective markets, either Business to Consumer (“B2C”) or Business to Business (“B2B”) channels, requiring us to develop distinct sales, marketing, and distribution methods. In particular, the B2C channels have different customers and distribution channels as B2B channels. Building, managing and maintaining such a sales and marketing infrastructure may require us to hire experts in the field, implement complex systems, establish collaborations with third parties effectively across various geographies and understand disparate regulatory regimes. Our ability to effectively engage in these steps is untested, making it impossible for us to accurately predict the level of success we will achieve.
We have yet to establish sales, marketing or distribution capabilities, and if we are unable to establish these capabilities, we may not be successful in commercializing our product candidates.
We have not yet established a sales, marketing or product distribution infrastructure for our product and service candidates, which are still in various stages of development. To achieve commercial success for any product, we will need to establish a sales and marketing organization within the United States and, potentially, also develop a strategy for sales outside of the United States. We intend to outsource the manufacturing and distribution, and failure to obtain contracts with such third parties on terms acceptable to us, or at all, may significantly delay our product and service candidates market rollout. In addition, as we begin to commercialize our products, we will need to hire, develop, train personnel with expertise in marketing and selling products in each of those markets.
Launching a marketing campaign for our products will be costly without any assurance the products will be purchased, used and accepted. As a start up with limited capital, there may not be enough time or capital to see this product through to market acceptance.
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Our revenue and results of operations may vary on an annual basis.
Our revenue and results of operations could vary significantly from period-to-period and may fail to match expectations as a result of a variety of factors, some of which are outside of our control, including general market conditions and macroeconomic factors. We have not yet generated revenues and we cannot accurately estimate future revenue and operating expenses based on historical performance. Our annual operating results may vary significantly based on many factors, including:
| ● | Fluctuating demand for our potential products; |
| ● | Announcements or implementation by our competitors of new products; |
| ● | Amount and timing of our costs related to our marketing efforts or other initiatives; |
| ● | Timing and amounts relating to the expansion of our operations; |
| ● | Our ability to enter into, renegotiate or renew key agreements; |
| ● | Timing and amounts relating to the expansion of our operations; or |
| ● | Economic conditions specific to our industry, as well as general economic conditions. |
As a result of the potential variations in our revenue and results of operations, period-to-period comparisons may not be meaningful and the results of any one period should not be relied on as an indication of future performance. We may also be unable to, or may elect not to, adjust spending quickly enough to offset any unexpected revenue shortfall. In addition, our results of operations may not meet the expectations of investors or public market analysts who follow the Company, which may adversely impact our stock price. We expect to make significant operating and capital expenditures in connection with the development of our plan of business. If these increased capital expenditures are not accompanied by increased revenue in the same period, our annual revenue and results of operations would be adversely affected.
If we fail to effectively manage our growth, our business will be harmed.
Currently, our three executive officers perform all required corporate functions, including product development activities. As we continue preparing for our service and product candidates to enter the market, we will, as availability of capital permits, begin to hire personnel necessary to support our operations. The skills we seek are typically in high demand and we may have difficulty identifying, hiring, integrating, motivating and retaining additional employees, consultants, and contract personnel. Also, our management may need to divert a disproportionate amount of our attention away from our day-to-day activities and devote a substantial amount of time to simultaneously manage rightsizing and growth activities. We may not be able to effectively manage changes in the size of our operations, which may result in weaknesses in our infrastructure, give rise to operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees.
Should we secure adequate capital, we intend to hire a Marketing and Sales Officer to implement plans for product distribution and channel placement. Regional distributors will be engaged to place product into their current customers retail and physician offices.
Any future growth could require significant capital expenditures and may divert financial resources from other projects, such as the development of product candidates. If our management is unable to effectively manage our rightsizing efforts while scaling the Company, our expenses may increase more than expected, our ability to generate and/or grow revenues could be reduced, and we may not be able to implement our business strategy. Our future financial performance and our ability to commercialize our product candidates and compete effectively will depend, in part, on our ability to effectively manage the size of our organization. We cannot assure you that we will be able to accomplish these tasks or effectively manage our growth.
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We are dependent upon our executive officers for future success.
Our future success to a significant extent depends on the continued services of our executive officers, Jose Antonio Reyes, Scott J. Silverman and Marvin S. Hausman, M.D. The departure of one or more of these people could materially adversely affect our ability to implement our business strategy. Currently, we do not maintain, for our benefit, any key man life insurance on any of our executive officers; we have, however, entered into employment and/or consulting agreements with Jose Antonio Reyes, Scott J. Silverman and Marvin S. Hausman, M.D. (See “Management”).
If we are unable to recruit and retain key personnel, our business may be harmed.
If we are unable to attract and retain key personnel, our business may be harmed. Our failure to enable the effective transfer of knowledge and facilitate smooth transitions with regard to our 3 key employees could adversely affect our long-term strategic planning and execution.
Our financial success is dependent to a significant degree upon the efforts of our executive officers. Our future success and viability will depend to a significant extent upon its ability to attract and retain qualified personnel in all areas of its business, especially its sales, science, and financial management teams. If we were to be unable to retain these key members of our respective teams, we would need to replace them with qualified individuals in a timely manner or our business, results of operations and financial condition could be adversely impacted.
Significant disruptions of information technology systems or security breaches could adversely affect our operations.
We are increasingly dependent upon information technology systems, infrastructure and data to operate our business ourselves and on vendors who operate aspects of our technology infrastructure for us. In the ordinary course of business, through the use of our product and service candidates, we will collect, store and transmit large amounts of confidential information (including, among other things, trade secrets or other intellectual property, proprietary business information and personal patient information). It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information.
Attacks on information technology systems are increasing in their frequency, levels of persistence, sophistication and intensity, and they are being conducted by increasingly sophisticated and organized groups that include state actors, criminal organizations and individuals who can bring significant resources and expertise to bear.
Our information technology systems, and those of third-party vendors with whom we contract are also vulnerable to service interruptions, security breaches from inadvertent or intentional actions by our employees, third-party vendors, and/or business partners, or from cyber-attacks by malicious third parties. Cyber-attacks could include the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering and other means to affect service reliability, and could threaten the confidentiality, integrity, and availability of information. For example, interruption of our information technology systems or technology infrastructure may cause delays in producing results for patients that utilize our products and/or services.
Significant disruptions of our information technology systems, or those of our third-party vendors, or security breaches could adversely affect our business operations and/or result in the loss, adulteration, misappropriation and/or unauthorized access, use or disclosure of, or the prevention of access to, confidential information, including, among other things, trade secrets or other intellectual property, proprietary business information and personal information, and could result in financial, legal, business, and reputational harm to us.
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Any such breach or interruption could compromise our networks, and the information stored there could be inaccessible or could be accessed by unauthorized parties, publicly disclosed, lost or stolen. Any such interruption in access, improper access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, such as the federal Health Insurance Portability and Accountability Act (“HIPAA”), and regulatory penalties. Unauthorized access, loss or dissemination could also disrupt our operations, including our ability to perform tests, provide test results, bill facilities or patients, process claims and appeals, provide customer assistance services, conduct research and development activities, collect, process and prepare Company financial information, provide information about our current and future solutions and other patient and clinician education and outreach efforts through our website, and manage the administrative aspects of our business and damage our reputation, any of which could adversely affect our business. Any such breach could also result in the compromise of our trade secrets and other proprietary information, which could adversely affect our competitive position.
Any failure or perceived failure by us or any third-party collaborators, service providers, contractors or consultants to comply with our privacy, confidentiality, data security or similar obligations to third parties, or any data security incidents or other security breaches that result in the unauthorized access, release or transfer of sensitive information, including personally identifiable information, may result in governmental investigations, enforcement actions, regulatory fines, litigation or public statements against us, could cause third parties to lose trust in us or could result in claims by third parties asserting that we have breached our privacy, confidentiality, data security, or similar obligations, any of which could have a material adverse effect on our reputation, business, financial condition, or results of operations. Moreover, data security incidents and other security breaches can be difficult to detect, and any delay in identifying them may lead to increased harm. While we have implemented data security measures intended to protect our information technology systems and infrastructure, there can be no assurance that such measures will successfully prevent service interruptions or data security incidents.
We process, store and use certain personal information, which subjects us to privacy laws and standards, governmental regulation and other legal obligations related to privacy, and our actual or perceived failure to comply with these privacy laws and standards, regulations, and obligations could subject us to fines, sanctions or litigation, and could potentially damage our brand and reputation and adversely affect our business, financial condition and results of operations.
We depend on information technology networks and systems to process, transmit and store electronic information and to communicate among our locations around the United States and with customers. We collect, use and disclose personal information, such as names, addresses, phone numbers and email addresses. We collect, store and use sensitive or confidential transaction and account information of consumers. As a result, we are or may be subject to a variety of state, national and international laws and regulations that apply to the collection, use, retention, protection, disclosure, transfer and other processing of personal data, potentially including the Fair Credit Reporting Act, the General Data Protection Regulation (“GDPR”) and California Consumer Privacy Act (“CCPA”). These laws and regulations are evolving, with new or modified laws and regulations proposed and implemented frequently and existing laws and regulations subject to new or different interpretations. For example, the GDPR introduced new data protection requirements in the EU and imposes substantial fines for breaches of the data protection rules. Compared to the previous EU data protection laws, the GDPR notably has a greater extra territorial reach and has a significant impact on data controllers and data processors, which either have an establishment in the EU, or offer goods or services to EU data subjects or monitor EU data subjects’ behavior within the EU. The GDPR regime imposes more stringent operational requirements on both data controllers and data processors, and introduces significant penalties for non-compliance with fines of up to 4% of total annual worldwide turnover or €20.0 million (whichever is higher), depending on the type and severity of the breach.
In addition, the CCPA expands the rights of California residents to access and require deletion of their personal information, opt out of certain personal information sharing and receive detailed information about how their personal information is used. The CCPA imposes a number of privacy and security obligations on companies who collect, use, disclose, or otherwise process personal information of California residents, which may result in civil penalties for violations and private rights of action in case of data breaches. The CCPA provides for civil penalties for violations, which could result in statutory penalties of up to $2,500 per violation, or up to $7,500 per violation if the violation is intentional. Other states have adopted, or are considering enacting, similar laws. Any failure or alleged failure to comply with privacy or data protection laws could lead to government enforcement actions and significant penalties against us, and could materially and adversely affect our reputation, business, financial condition, cash flows and results of operations. Compliance with any of the foregoing laws and regulations can be costly, can delay or impede the development of new products, and may require us to change the way we operate.
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Additionally, the California Privacy Rights Act (“CPRA”), which took effect on January 1, 2023 and significantly expands the CCPA, imposes additional data protection obligations on companies doing business in California, including additional consumer rights processes and opt outs for certain uses of sensitive data and sharing of personal data as well as an expanded definition of “sale” to include sharing of personal information, and data minimization and data retention requirements. The CPRA also establishes a new enforcement agency, the California Privacy Protection Agency, which may take a more active role in enforcement. Other states have and are likely to continue to implement their own privacy statutes in the near term. The effects of the CCPA, CPRA and other similar state regulations are potentially significant and may require us to modify our data collection or processing practices and policies and to incur substantial costs and expenses in an effort to comply and increase our potential exposure to regulatory enforcement and/or litigation. Any of the foregoing could materially and adversely affect our business, results of operations and financial condition.
We may also be subject to or affected by evolving federal, state and foreign data protection laws and regulations, such as laws and regulations that address privacy and data security. In the United States, federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data privacy laws, and consumer protection laws (e.g. Section 5 of the Federal Trade Commission Act). For example, HIPAA as amended by the Health Information Technology for Economic and Clinical Health Act, imposes specific requirements relating to the privacy, security, and transmission of individually identifiable health information. We may obtain health information or other personal information from third parties, including research institutions from which we obtain clinical trial data, that are subject to privacy and security requirements under HIPAA. While we do not believe that we are currently acting as a covered entity or business associate under HIPAA and thus are not directly regulated under HIPAA, any person may be prosecuted under HIPAA’s criminal provisions if it knowingly receives individually identifiable health information from a HIPAA-covered healthcare provider or research institution that has not satisfied HIPAA requirements for disclosure of individually identifiable health information under aiding-and-abetting or conspiracy principles.
The interpretation and application of many privacy and data protection laws are uncertain. Anticipated further evolution of regulations on this topic may substantially increase the penalties to which we could be subject to in the event of any non-compliance. These laws may be interpreted and applied in a manner that is inconsistent with our existing data management practices or the features of our products. If so, in addition to the possibility of negative publicity, fines, lawsuits and other claims and penalties, we could be required to fundamentally change our business activities and practices or modify our products, which could harm our business.
We seek to comply with privacy related industry standards and are subject to the terms of our own privacy policies and privacy related obligations to third parties. We strive to comply with all applicable laws, policies, legal obligations and industry codes of conduct relating to privacy and data security protection to the extent possible. However, these obligations may be interpreted and applied in a manner that is inconsistent from one jurisdiction to another and may conflict with other rules or regulations, making enforcement, and thus compliance requirements, ambiguous, uncertain, and potentially inconsistent. Additionally, laws, regulations, and standards covering marketing and advertising activities conducted by telephone, email, mobile devices, and the internet may be applicable to our business, such as the Telephone Consumer Protection Act (as implemented by the Telemarketing Sales Rule), the CAN SPAM Act of 2003, and similar state consumer protection laws. Any failure or perceived failure by us to comply with our privacy policies, privacy related obligations to agents, clients or other third parties, or our privacy related legal obligations, any marketing or advertising related laws, regulations, or standards, or any compromise of security that results in the unauthorized access to or unintended release of personal information or other agent or client data, may result in governmental enforcement actions, litigation, or public statements against us by consumer advocacy groups or others. Any of these events could cause us to incur significant costs in investigating and defending such claims and, if found liable, pay significant damages. Further, these proceedings and any subsequent adverse outcomes may cause our agents and clients to lose trust in us, which could have a material adverse effect on our reputation and business.
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We are also subject to laws and regulations that involve electronic contracts and other communications; consumer protection; and online payment services. These laws and regulations are constantly evolving and can be subject to significant change. For example, many states have ordinances in place allowing individuals with certain criminal backgrounds to become tenants. State ordinances vary from state to state, and the types of criminal backgrounds that will clear a background check are not uniform on a national scale. As a result, the application, interpretation, and enforcement of these laws and regulations are often uncertain and may be interpreted and applied inconsistently. Additionally, as we depend on third parties for key services, we rely on such third-party service providers’ compliance with laws and regulations regarding privacy, data protection, consumer protection, and other matters relating to our customers.
Any significant change to applicable laws, regulations or industry practices regarding the use or disclosure of personal information, or regarding the manner in which the express or implied consent of agents and their clients for the use and disclosure of personal information is obtained, could require us to modify our platform and its features, possibly in a material manner and subject us to increased compliance costs, which may limit our ability to innovate, improve and expand our platform and its features that make use of the personal information that our agents and their clients voluntarily share. Our customers operate independent of our platform as well and are responsible for their own data privacy compliance in certain respects. Additionally, we provide training and our platform provides tools and security controls to assist our agents with their data privacy compliance to the extent they store relevant data on our platform. However, if a customer or tenant on our platform were to be subject to a claim for breach of data privacy laws, we could possibly be found liable for their claims due to our relationship, which can require us to take more costly data security and compliance measures or to develop more complex systems.
Our business plan is not based on independent market studies.
We have not commissioned any independent market studies concerning our plans of operations. Rather, our plans for implementing our business strategy and achieving profitability are based on the experience, judgment and assumptions of our management. If these assumptions prove to be incorrect, we may not be successful in our business operations.
Our Board of Directors may change our policies without stockholder approval.
Our policies, including any policies with respect to investments, leverage, financing, growth, debt and capitalization, will be determined by our Board of Directors or officers to whom our Board of Directors delegate such authority. Our Board of Directors will also establish the amount of any dividends or other distributions that we may pay to our stockholders. Our Board of Directors or officers to which such decisions are delegated will have the ability to amend or revise these and our other policies at any time without stockholder vote. Accordingly, our stockholders will not be entitled to approve changes in our policies, which policy changes may have a material adverse effect on our financial condition and results of operations.
There are limitations of director liability and indemnification of directors, officers and employees.
Pursuant to Section 75.0002 of the Nevada Revised Statutes, we have the power to indemnify any person made a party to any lawsuit by reason of being a director or officer of the Company, or serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by him in connection with such action, suit or proceeding if he acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe his conduct was unlawful. Our Articles of Incorporation provide that the Company shall indemnify its directors and officers to the fullest extent permitted by Nevada law.
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These limitations of liability do not apply to liabilities arising under the federal or state securities laws and do not affect the availability of equitable remedies such as injunctive relief or rescission. Our corporate bylaws provide that we will indemnify our directors, officers and employees to the fullest extent permitted by law. Our bylaws also provide that we are obligated to advance expenses incurred by a director or officer in advance of the final disposition of any action or proceeding. We believe that these bylaw provisions are necessary to attract and retain qualified persons as directors and officers. The limitation of liability in our Articles of Incorporation and bylaws may discourage stockholders from bringing a lawsuit against directors for breach of their fiduciary duties. They may also reduce the likelihood of derivative litigation against directors and officers, even though an action, if successful, might provide a benefit to us and our stockholders. Our results of operations and financial condition may be harmed to the extent we pay the costs of settlement and damage awards against directors and officers pursuant to these indemnification provisions.
We are an emerging growth company and a smaller reporting company and intend to take advantage of reduced disclosure requirements applicable to emerging growth companies, which could make the Common Stock less attractive to investors.
We are an “emerging growth company” (“EGC”) as defined in the Jumpstart Our Business Startups Act of 2012. we will remain an EGC until the earliest to occur of (i) the last day of the fiscal year in which it has total annual gross revenue of $1.235 billion or more; (ii) the last day of the fiscal year following the fifth anniversary of the date of the first sale of Common Stock pursuant to the registration statement; (iii) the date on which it has issued more than $1.0 billion in non-convertible debt securities during the prior three-year period; or (iv) the date it qualifies as a “large accelerated filer” under the rules of the SEC, which means the market value of the Common Stock held by non-affiliates exceeds $700 million as of the last business day of its most recently completed second fiscal quarter after it has been a reporting Company in the United States for at least 12 months. For so long as we remain an EGC, we are permitted to and intend to rely upon exemptions from certain disclosure requirements that are applicable to other public companies that are not EGCs. These exemptions include not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure about our executive compensation arrangements.
We may choose to take advantage of some but not all of these reduced burdens. We have taken advantage of reduced reporting requirements in this prospectus. Accordingly, the information contained herein may be different from the information you receive from other public companies in which you hold stock. In addition, Section 107 of the Jumpstart Our Business Startups Act (the “JOBS Act”) provides that an EGC may take advantage of an extended transition period for complying with new or revised accounting standards, delaying the adoption of these accounting standards until they would apply to private companies. We have elected to avail ourselves of the extended transition period for complying with new or revised financial accounting standards. As a result of our accounting standards election, we will not be subject to the same implementation timing for new or revised accounting standards as other public companies that are not EGC’s which may make comparison of our financials to those of other public companies more difficult.
We are also a smaller reporting company, as defined in Rule 405 promulgated under the Securities Act of 1933 (the “Securities Act”). As an SRC, the Company intends to utilize certain reduced disclosure requirements, including publishing two years of audited financial statements instead of three years, as required for companies that do not qualify as an SRC. The Company will remain an SRC until the last day of the fiscal year in which it had (i) a public float that exceeded $250 million or (ii) annual revenues of more than $100 million and a public float that exceeded $700 million. To the extent the Company takes advantage of such reduced disclosure obligations, it may make comparison of its financial statements to those of other public companies difficult or impossible.
After the Company ceases to be an SRC, it is expected to incur additional management time and cost to comply with the more stringent reporting requirements applicable to companies that are accelerated filers or large accelerated filers, including complying with the auditor attestation requirements of Section 404 of SOX.
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Risks Related to Our Business
We use RNA-based molecular biology in our products and services pipeline and the successful commercialization of these products will depend on public perceptions of RNA-based products.
The successful commercialization of our product candidates depends, in part, on public acceptance of modern biotechnology techniques and the use of RNA genetic biomarkers to identify differentially expressed genes (“DEGs”) involved in the inflammatory process associated with the development of chronic diseases, such as heart disease and cancer. Negative public perceptions about RNA and molecular regulation of gene expression can also affect the regulatory environment in the jurisdictions in which we are targeting the sale of our products and the commercialization of our product candidates. Any increase in such negative perceptions or any restrictive government regulations in response to RNA-based products could have a negative effect on our business and may delay or impair the sale of our products or the development or commercialization of our product candidates. Public pressure may lead to increased regulation and legislation for products produced using genetic biotechnology and this could adversely affect our ability to sell our product or commercialize our product candidates.
If the U. S. Food and Drug Administration (the “FDA”) were to begin actively regulating our tests, we could incur substantial costs and delays associated with trying to obtain premarket clearance or approval and incur costs associated with complying with post-market controls.
We intend to launch and market each of our proprietary testing products as a laboratory-developed test (“LDT”). We believe each of our proprietary testing products that we will offer are LDTs. The FDA generally considers an LDT to be a test that is developed, validated and performed within a single laboratory. The FDA sometimes determines that a test that is being offered by a laboratory as an LDT is not an LDT under the FDA’s interpretation of that term but is an in vitro diagnostic (“IVD”) medical device in commercial distribution, and therefore must comply with the regulations that apply to IVDs, including the need for successfully completing the FDA review process. If the FDA were to conclude that our proprietary testing product is not an LDT, we would be subject to extensive regulation as a medical device.
Moreover, even for tests that are deemed to be LDTs, the FDA has historically taken the position that it has the authority to regulate such tests as IVDs under the Federal Food, Drug, and Cosmetic Act, or FDC Act, although it has generally exercised enforcement discretion with regard to LDTs. This means that even though the FDA believes it can impose regulatory requirements on LDTs, such as requirements to obtain premarket approval, de novo authorization or clearance of LDTs, it has generally chosen not to enforce those requirements. The regulatory environment for LDTs has changed over time. For example, in 2020, the Department of Health and Human Services, or HHS, directed the FDA to stop regulating LDTs, but in 2021, HHS reversed its policy. Thereafter, the FDA resumed requiring submission of emergency use authorization, or EUA, requests, for COVID-19 LDTs, but has not indicated an intent to change its policy of enforcement discretion with respect to other, non-COVID, LDTs. Various bills have been introduced in Congress seeking to substantially revamp the regulation of both LDTs and IVDs. For example, the VALID Act, introduced in June 2021, would clarify and enhance the FDA’s authority to regulate LDTs, while the VITAL Act, introduced in May 2021, would assign oversight of LDTs exclusively to the Centers for Medicare and Medicaid Services, or CMS.
Neither the VALID Act nor the VITAL Act has been enacted into law as of the date of this prospectus. Although the VALID Act was favorably voted upon in June 2022 by the Senate Health, Education, Labor and Pensions Committee as part of the FDA Safety and Landmark Advancements bill, it was not included in the version of that legislation that was enacted by Congress and signed into law. Congress may, through the enactment of other legislation during the current session of Congress or the subsequent Congress, enact VALID or establish new regulatory requirements for LDTs through other legislation.
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In the meantime, the regulation by the FDA of LDTs remains uncertain. The FDA may, if Congress does not enact new legislation, seek to establish new requirements for LDTs. If FDA premarket clearance, approval or authorization is required by the FDA for any of our future proprietary testing products, or for any components or materials we use in our tests, such as the component used to collect samples from patients, we may be forced to stop selling our tests or we may be required to modify claims for or make other changes to our tests while we work to obtain FDA clearance, approval or de novo authorization. Our business would be adversely affected while such review is ongoing and if we are ultimately unable to obtain premarket clearance, approval or de novo authorization. For example, the regulatory premarket clearance, approval or de novo authorization process may involve, among other things, successfully completing analytical, pre-clinical and/or clinical studies beyond the studies we have already performed or plan to perform for our LDT. These studies may be extensive and costly and may take a substantial period of time to complete. Any such studies may fail to generate data that meets the FDA’s requirements. The studies may also not be conducted in a manner that meets the FDA’s requirements, and therefore could not be used in support of the marketing application. We would also need to submit a premarket notification, or 510(k), a request for de novo authorization, or a PMA application to the FDA and to include information (e.g., clinical and other data) supporting our LDT. Completing such studies requires the expenditure of time, attention and financial and other resources, and may not yield the desired results, which may delay, limit or prevent regulatory clearances, approvals or de novo authorizations. There can be no assurance that the submission of such an application will result in a timely response by the FDA or a favorable outcome that will allow the test to be marketed.
Certain types of standalone diagnostics software are subject to FDA regulation as a medical device (specifically, software as a medical device or “SaMD”). Some types of SaMD are subject to premarket authorization requirements. If the FDA were to conclude that the proprietary mRNA technology we have developed to predict the presence of inflammatory-driven diseases and monitor patient treatment responses through artificial intelligence is required to obtain premarket authorization for the software used to analyze the mRNA genetic score, our ability to offer the test as an LDT could be delayed or prevented, which would adversely affect our business.
In addition, we may require cooperation in our filings for FDA clearance, approval or de novo authorization from third-party manufacturers of the components of our tests.
We cannot assure investors that any of our tests for which we decide to pursue or are required to obtain premarket clearance, approval or de novo authorization by the FDA will be cleared, approved or authorized on a timely basis, if at all. In addition, if a test has been cleared, approved or authorized, certain kinds of changes that we may make, e.g., to improve the test, or because of issues with suppliers of the components of the test or modification by a supplier to a component upon which our test approval relies, may result in the need for the test to obtain new clearance, approval or authorization from the FDA before we can implement them, which could increase the time and expense involved in implementing such changes commercially. Ongoing compliance with FDA regulations, such as the Quality System Regulation, labeling requirements, Medical Device Reports, and recall reporting, would increase the cost of conducting our business and subject us to heightened regulation by the FDA. We will be subject to periodic inspection by the FDA to ascertain whether our facility does comply with applicable requirements. The penalties for failure to comply with these and other requirements may include Warning Letters, product seizure, injunctions, civil penalties, criminal penalties, mandatory customer notification, and recalls, any of which may adversely impact our business and results of operations.
Furthermore, the FDA or the Federal Trade Commission (“FTC”), as well as state consumer protection agencies and competitors, may object to the materials and methods we use to promote the use of our current tests or other LDTs we may develop in the future, including with respect to the product claims in our promotional materials, and may initiate enforcement actions against us. Enforcement actions by these agencies may include, among others, injunctions, civil penalties, and equitable monetary relief.
For more information, see “Business – Laboratory Developed Test (LDT)” below.
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We are in competition with companies that are larger, more established and better capitalized than we are.
The medical testing products industry is highly competitive, rapidly evolving and subject to constant change. The number of competitors in our industry is substantial. We expect that if our products establish a market niche, competition will arise from a variety of sources, including from large healthcare companies to other smaller national and regional healthcare companies.
Many of our potential competitors possess:
| ● | greater financial, technical, personnel, promotional and marketing resources; |
| ● | longer operating histories; |
| ● | greater name recognition; and |
| ● | larger consumer bases. |
We cannot assure you that we will be able to compete effectively in our extremely competitive industry.
Our mRNA product candidates are based on innovative technologies and any product candidates we develop may be more complex and more difficult to manufacture than initially anticipated. We may encounter difficulties with manufacturing processes, manufacturing at higher volumes, product releases, product shelf life and storage, supply chain management, or shipping for any of our products. If we or any of our third-party vendors encounter such difficulties, our ability to supply commercial products or material for clinical studies could be delayed or stopped.
We have applied medical machine learning technology that uses RNA-based inflammatory genetic biomarkers to assist in disease diagnosis, monitoring and assessment of patient responses to certain treatment modalities. The manufacturing processes for our mRNA genomic technology are innovative and complex. To the best of our knowledge, there are no competitive mRNA products currently manufactured at commercial scale. Due to the complexities of this technology and our limited experience at commercial scale production, we could encounter difficulties with manufacturing processes, manufacturing at higher volumes, product releases, product shelf life and storage issues, supply chain management, or shipping.
There may also be a high degree of technological change that can negatively impact our product comparability during and after clinical development. Furthermore, technology changes may drive the need for changes in, modification to, or the sourcing of new manufacturing infrastructure or may adversely affect third-party relationships.
The process to generate mRNA product candidates is complex and, if not developed and manufactured under well-controlled conditions, can adversely impact pharmacological outcomes and may result in one or more of our product candidates’ failures. To date, we have not completed the development of our product candidates and there is no assurance that, once developed, any of our products will be accepted by our targeted customers. If we do not successfully develop and commercialize our products based upon this technological approach, we may not become profitable, and our results of operations may be adversely affected.
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The materials used in our diagnostic tests processes and those used to manufacture RNA-based products and our derivative products, such as mRNA genetic microarrays, may become difficult to obtain in the quality or quantity required for our business plans or at the prices that are currently projected.
Many of our processes and products rely on materials purchased from third parties and should these materials increase in prices, have supply constraints, or become unavailable, it could impact our ability to develop products or bring them to market either on time, at competitive prices or at all. For example, some of our protein diagnostic tests that we use to identify inflammatory related diseases, such as “ELISA” (as defined below) and Apoptotic Index™ technology, may use compounds that are sourced from suppliers in China. Further, mRNA panels used in our diagnostic tests are produced by a third-party. As such, should these particular components become unavailable, the effectiveness, yield or availability of some of our available laboratory tests could be impaired.
We rely on highly specialized equipment and consumables for the production of our derivative products, and any disruption to the supply chain or any malfunction of that equipment may adversely impact our operations.
The equipment and consumables used in our tests are currently supply constrained, which may cause delays in development, testing or marketing of our human health products and may require us to ultimately increase prices should our products become available to consumers.
Additionally, we will be dependent on equipment providers and third-party contract manufacturing organizations (“CMOs”) who are also implementing innovative technology. For instance, we will use medical AI technology that uses mRNA-based genetic biomarkers to assess the presence of chronic inflammatory driven diseases and monitor patient treatment responses. This AI technology is run on a third-party equipment. If such equipment malfunctions or if we encounter unexpected performance issues, we could encounter delays or interruptions to clinical and commercial supply.
Delivery delays or unavailability of products, services, or equipment provided by suppliers could require us to change the design of our research, development, and manufacturing processes based on the functions, limitations, features, and specifications of the replacement items or seek out a new supplier to provide these items. Additionally, as we grow, our existing suppliers may not be able to meet our increasing demand, and additional suppliers may need to be found. We may not be able to secure suppliers who provide lab supplies at, or equipment and services to, the specification, quantity, and quality levels that we demand (or at all) or be able to negotiate acceptable fees and terms of services with such suppliers.
If we are unable to develop and later market our products under development in a timely manner or at all, or if competitors develop or introduce similar products that achieve commercialization before our products enter the market, the demand for our products may decrease or the products could become obsolete.
Our products will compete in competitive markets, where competitors may already be well established. We expect that competitors will continue to innovate, develop, and introduce similar products that could be competitive in both price and performance. Competitors may succeed in developing or introducing similar products earlier than us, obtain regulatory approvals and clearances before our products are approved and cleared, or develop more effective products. In addition, competitors may have products which may achieve commercialization before our products enter the market.
Our marketing strategies for our products may not be successful.
We will be required to attract customers to our products, all of which will be new upon their introduction. Should our marketing strategies fail to establish sales of our products, our operations will be adversely affected.
Additionally, the use of home testing kits to assess chronic inflammatory related disease conditions may not be perceived as needed in the market, especially if the testing kit is not paid for by insurance. Relying on customers to pay out of pocket for these kits is potentially a very large impediment to product use and acceptance. We do not currently plan to seek insurance coverage for use of the home testing kits.
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Our business may be affected by litigation and government investigations.
We may from time to time receive inquiries and subpoenas and other types of information requests from government authorities and others and we may become subject to claims and other actions related to our business activities. While the ultimate outcome of investigations, inquiries, information requests and legal proceedings is difficult to predict, defense of litigation claims can be expensive, time-consuming, and distracting, and adverse resolutions or settlements of those matters may result in, among other things, modification of our business practices, costs and significant payments, any of which could have a material adverse effect on our business, financial condition, results of operations and prospects.
Our intellectual property rights are valuable, and any inability to protect them could reduce the value of our products and brand.
We have invested, and will continue to invest resources to protect our brands and intellectual property rights. However, we may be unable or unwilling to strictly enforce our intellectual property rights, including our patents and trademarks, from infringement. Our failure to enforce our intellectual property rights could diminish the value of our brands and product offerings and harm our business and future growth prospects.
If we are unable to obtain and maintain patent protection for our technology and products, or if any licensors are unable to obtain and maintain patent protection for the technology or products that we may license from them in the future, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be adversely affected.
As of September 16, 2025, we have 3 patent applications filed, or under examination in key global jurisdictions relating to our products. Our future success depends in large part on our and, as applicable, our licensors’, ability to obtain and maintain patent protection in the United States and other countries with respect to our proprietary technology. We cannot be certain that patents will be issued in those countries where our applications are still under examination.
The patent process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our R&D output before it is too late to obtain patent protection.
The patent position of biotechnology and pharmaceutical companies is generally highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are uncertain. Our pending and future patent applications may not result in patents being issued which protect our technology or products or which effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection.
The laws of foreign countries may not protect our rights to the same extent as the laws of the United States. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing. Therefore, we cannot be certain that we or our licensors were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we or our licensors were the first to file for patent protection of such inventions.
Assuming the other requirements for patentability are met, in the United States, for patents that have an effective filing date prior to March 15, 2013, the first to make the claimed invention is entitled to the patent, while outside the United States, the first to file a patent application is entitled to the patent. In March 2013, the United States transitioned to a first inventor to file system in which, assuming the other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent. We may be subject to a third-party pre-issuance submission of prior art to the U.S. Patent and Trademark Office, or become involved in opposition, derivation, reexamination, inter parties review or interference proceedings challenging our patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights.
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Even if our owned and licensed patent applications are issued as patents, they may not be issued in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our owned or licensed patents by developing similar or alternative technologies or products in a non-infringing manner.
The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.
We may become involved in lawsuits to protect or enforce our patents, which could be expensive, time-consuming and unsuccessful.
Competitors may infringe on our patents. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, our licensors may have rights to file and prosecute such claims and we are reliant on them.
Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
Our commercial success depends upon our ability and the ability of our collaborators to develop, manufacture, market and sell our products and product candidates and use our proprietary technologies without infringing the proprietary rights of third parties. We have yet to conduct comprehensive freedom-to-operate searches to determine whether our use of certain of the patent rights owned by or licensed to us would infringe patents issued to third parties. We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our products and technology, including interference proceedings before the U.S. Patent and Trademark Office and their European Union and global equivalents. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future. If we are found to infringe a third party’s intellectual property rights, we could be required to obtain a license from such third party to continue developing and marketing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing technology or product. In addition, we could be found liable for monetary damages. A finding of infringement could prevent us from commercializing our product candidates or force us to cease some of our business operations, which could materially harm our business. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business.
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Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our Common Stock. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
In addition to seeking patents for some of our technology and products, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position. We seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, CMOs, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position would be harmed.
If we are unable to obtain and maintain protection of our intellectual property, which are costly to maintain, the value of our products may be adversely affected.
Our industry is characterized by vigorous pursuit and protection of intellectual property rights, which has resulted in protracted and expensive litigation for several companies. Third parties may assert claims of misappropriation of trade secrets or infringement of intellectual property rights against us or against our end customers or partners for which we may be liable.
As our business expands, the number of products and competitors in our markets can be expected to increase and product overlaps to occur, and infringement claims may increase in number and significance. Intellectual property lawsuits are subject to inherent uncertainties due to the complexity of the technical issues involved, and we cannot be certain that we would be successful in defending ourselves against intellectual property claims. Further, many potential litigants have the capability to dedicate substantially greater resources than we can to enforce their intellectual property rights and to defend claims that may be brought against them. Furthermore, a successful claimant could secure a judgment that requires us to pay substantial damages or prevents us from distributing products or performing certain services.
We attempt to protect our intellectual property position, in part, by filing patent applications related to our proprietary technology, inventions and improvements that are important to our business. However, our patent and trademark positions are not likely by itself to prevent others from commercializing products that compete directly with our products. In addition, the patents and trademarks owned by us or issued to us could be challenged, invalidated, or held to be unenforceable. We also note that any patent granted may not provide a competitive advantage to us. Our competitors may independently develop technologies that are substantially similar or superior to our technologies. Further, third parties may design around our patented or proprietary products and technologies.
We rely on certain trade secrets and we may not be able to adequately protect our trade secrets even with contracts with our personnel and third parties. Also, any third party could independently develop and have the right to use, our trade secret, know-how and other proprietary information. If we are unable to protect our intellectual property rights, our business, prospects, financial condition and results of operations could suffer materially.
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We may not be successful in registering and enforcing our trademarks.
As we apply to register our unregistered trademarks in the United States and other countries, our applications may not be allowed for registration in a timely fashion or at all, and our registered trademarks may not be maintained or enforced. Trademark enforcement is always uncertain, since proving infringement requires a showing of consumer confusion in addition to use by the defendant of a similar or identical trademark. In addition, opposition or cancellation proceedings may be filed against our trademark applications and registrations, and our trademarks may not survive such proceedings. In certain countries outside of the United States, trademark registration is required to enforce trademark rights. If we do not secure registrations for our trademarks, we may encounter more difficulty in enforcing them against third parties than we otherwise would.
Risks Related to an Investment in Our Securities
Persons who purchase shares of our Common Stock may lose their money without us ever being able to develop an active market.
In the event that no active market to purchase our Common Stock is ever created, it is likely that the entire investment of a purchaser in our Common Stock would be lost.
We are authorized to issue Convertible Preferred Stock without stockholder approval, which could adversely impact the rights of holders of our securities.
Our articles of incorporation authorize us to issue up to 7,000,000 shares of Convertible Preferred Stock. Any Convertible Preferred Stock that we issue in the future may rank ahead of our securities in terms of dividend priority or liquidation premiums and may have greater voting rights than our securities. In addition, such Convertible Preferred Stock may contain provisions allowing those shares to be converted into shares of Common Stock, which could dilute the value of our Common Stock to current stockholders and could adversely affect the market price, if any, of our Common Stock. In addition, the Convertible Preferred Stock could be utilized, under certain circumstances, as a method of discouraging, delaying or preventing a change in control of our Company. Although we have no present intention to issue any shares of authorized convertible preferred stock after the conversion of all of the outstanding shares, there can be no assurance that we will not do so in the future.
We have outstanding indebtedness pursuant to the Convertible Notes, and default on such Convertible Notes may adversely affect our financial condition and ability to operate our business.
If the holders of the Convertible Notes determine not to convert the Convertible Notes into shares of our Common Stock, we may be unable to discharge such obligations when due. In such circumstance, we would be in default on each of the Convertible Notes, which would have a severe material adverse effect on our ability to operate our business. None of the Convertible Notes is due until, at the earliest, March 31, 2026.
In addition, we may need additional financing to support our business and pursue our growth strategy, including for pursuing our future planned studies. Our ability to obtain additional financing, if and when required, will depend on investor demand, our operating performance, the condition of the capital markets and other factors. We cannot assure you that additional financing will be available to us on favorable terms when required, or at all. If we raise additional funds through the issuance of equity, equity-linked or debt securities, those securities may have rights, preferences or privileges senior to those of our Common Stock, and, in the case of equity and equity-linked securities, our existing shareholder may experience dilution.
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We may seek capital that may result in stockholder dilution or that may have rights senior to those of our Common Stock.
From time to time, we may seek to obtain additional capital, either through equity, equity linked or debt securities. The decision to obtain additional capital will depend on, among other factors, our business plans, operating performance and condition of the capital markets. If we raise additional funds through the issuance of equity, equity linked or debt securities, those securities may have rights, preferences or privileges senior to the rights of our Common Stock, which could negatively affect the market price of our Common Stock or cause our stockholders to experience dilution.
Given that we do not have committed sources of financing, we may attempt to raise capital by selling shares, possibly at a deep discount to market. These actions may result in dilution of the ownership interests and voting power of existing stockholders, further dilute Common Stock book value, and may delay, defer or prevent a change of control.
Future issuances of debt securities and equity securities could negatively affect the market price of shares of our Common Stock and, in the case of equity securities, may be dilutive to existing stockholders.
In the future, we may issue debt or equity securities or incur other financial obligations, including stock dividends. Upon liquidation, it is possible that holders of our debt securities and other loans and preferred stock would receive a distribution of our available assets before Common Stockholders. We are not required to offer any such additional debt or equity securities to existing stockholders on a preemptive basis. Therefore, additional Common Stock issuances, directly or through convertible or exchangeable securities, warrants or options, would dilute the holdings of our existing Common Stockholders and such issuances, or the perception of such issuances, could reduce the market price of shares of our Common Stock.
We do not intend to pay dividends on our Common Stock.
We intend to retain earnings, if any, to provide funds for the implementation of our business strategy. We do not intend to declare or pay any dividends in the foreseeable future. Therefore, there can be no assurance that holders of our Common Stock will receive cash, stock or other dividends on their shares of our Common Stock, until we have funds which our Board of Directors determines can be allocated to dividends. Further, our Common Stock may be less valuable because a return on your investment will only occur if our stock price appreciates.
We have broad discretion in the use of funds and may not use them effectively.
Our management will have broad discretion in the application of our funds and you will not have the opportunity as part of your investment decision to assess whether the net proceeds will be used appropriately. Because of the number and variability of factors that will determine our use of funds, their ultimate use may vary substantially from their currently intended use. Furthermore, our management will have broad discretion in the application of our funds, and investors will be relying on our judgment regarding the application of these funds.
The failure by our management to use our funds effectively could harm our business. Pending their use, we may invest our funds in short-term, investment-grade, interest-bearing securities. These investments may not yield a favorable return to our stockholders. If we do not invest our funds in ways that enhance stockholder value, we may fail to achieve expected financial results, which could cause our stock price to decline.
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Because our Common Stock is considered a “penny stock,” any investment in our Common Stock is considered to be a high-risk investment and is subject to restrictions on marketability.
Our Common Stock is considered a “penny stock” because it is quoted on the OTCID and it trades for less than $5.00 per share. The OTCID is generally regarded as a less efficient trading market than the Nasdaq Capital or Global Markets or the New York Stock Exchange. The SEC has rules that regulate broker dealer practices in connection with transactions in “penny stocks.”
Penny stocks generally are equity securities with a price of less than $5.00 per share (other than securities registered on certain national securities exchanges, provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system). The penny stock rules require a broker dealer, prior to a transaction in a penny stock not otherwise exempt from those rules, to deliver a standardized risk disclosure document prepared by the SEC, which specifies information about penny stocks and the nature and significance of risks of the penny stock market. The broker dealer also must provide the customer with bid and offer quotations for the penny stock, the compensation of the broker dealer and any salesperson in the transaction, and monthly account statements indicating the market value of each penny stock held in the customer’s account. In addition, the penny stock rules require that, prior to effecting a transaction in a penny stock not otherwise exempt from those rules, the broker dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction. These disclosure requirements may have the effect of reducing the trading activity in the secondary market for our Common Stock. Since our Common Stock is subject to the regulations applicable to penny stocks, the market liquidity for our Common Stock could be adversely affected because the regulations on penny stocks could limit the ability of broker dealers to sell our Common Stock and thus your ability to sell our Common Stock in the secondary market in the future.
We can provide no assurance that our Common Stock will be quoted or listed on any trading platform of higher quality than the OTCID, including the OTCQB, or any exchange, even if eligible, in the future.
It is possible that our Common Stock will continue to experience volatility in its trading volume and its market price.
Our Common Stock is quoted in the over-the-counter market under the symbol “LUDG” on the OTCID. For over the past five years, our Common Stock has experienced both volume and price volatility. The market for low-priced securities is generally less liquid and more volatile than securities traded on national stock markets. Wide fluctuations in market prices are not uncommon.
The price of our Common Stock may be subject to wide fluctuations in response to factors such as the following, some of which are beyond our control:
| ● | annual variations in our operating results; |
| ● | operating results that vary from the expectations of investors; |
| ● | changes in expectations as to our future financial performance, including financial estimates by investors; |
| ● | reaction to our periodic filings, or presentations by executives at investor and industry conferences; |
| ● | changes in our capital structure; |
| ● | announcements of innovations or new products by us or our competitors; |
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| ● | announcements by us or our competitors of significant contracts, acquisitions, strategic partnerships, joint ventures or capital commitments; |
| ● | lack of success in the expansion of our business operations; |
| ● | third-party announcements of claims or proceedings against us or adverse developments in pending proceedings; |
| ● | additions or departures of key personnel; |
| ● | asset impairment; |
| ● | temporary or permanent inability to offer products or services; and |
| ● | rumors or public speculation about any of the above factors. |
If our annual operating results fall below the expectations of investors or securities analysts, the price of our Common Stock could decline substantially. Furthermore, any fluctuations in our operating results may, in turn, cause the price of our stock to fluctuate substantially. We believe that comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of our future performance.
In the past, following periods of volatility in the market price of a company’s securities, securities class-action litigation often has been instituted against that company. Such litigation, if instituted against us, could cause us to incur substantial costs to defend such claims and divert management’s attention and resources.
The costs of being a public company could result in us being unable to continue as a going concern.
As a public company, we are required to comply with numerous financial reporting and legal requirements, including those pertaining to audits and internal control. The costs of maintaining public company reporting requirements could be significant and may preclude us from seeking financing or equity investment on terms acceptable to us and our stockholders. We estimate these costs to be approximately $125,000 per year and may be higher if our business volume or business activity increases significantly. We estimate that our costs will increase if we are able to successfully uplist to a senior exchange such as the NYSE American or NASDAQ stock exchanges.
To the extent that funds generated from any private placements, public annual reports and/or bank financing are insufficient, we will have to raise additional working capital and no assurance can be given that additional financing will be available, or, if available, will be on acceptable terms. The recent interest rate hikes and the present conditions and state of the United States and global economies make it difficult to predict whether and/or when and to what extent a recession has occurred or will occur in the near future. These conditions potentially raise substantial doubt about our ability to continue as a going concern. If adequate working capital is not available, we may be forced to discontinue operations, which would cause investors to lose their entire investment.
Techniques employed by short sellers may drive down the market price of the Common Stock.
Short selling is the practice of selling securities that the seller does not own but rather has borrowed from a third party with the intention of buying identical securities back at a later date to return to the lender. The short seller hopes to profit from a decline in the value of the securities between the sale of the borrowed securities and the purchase of the replacement shares, as the short seller expects to pay less in that purchase than it received in the sale.
As it is in the short seller’s interest for the price of the security to decline, many short sellers publish, or arrange for the publication of, negative opinions regarding the relevant issuer and our prospects to create negative market momentum and generate profits for themselves after selling a security short. These short attacks have, in the past, led to selling of shares in the market.
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It is not clear what effect such negative publicity could have on us. If we were to become the subject of any unfavorable allegations, whether such allegations are proven to be true or untrue, we could have to expend significant resources to investigate such allegations and/or defend ourselves.
While we would strongly defend against any such short seller attacks, we may be constrained in the manner in which we can proceed against the relevant short seller by principles of freedom of speech, applicable state law or issues of commercial confidentiality. Such a situation could be costly and time-consuming, and could distract our management from growing our business. Even if such allegations are ultimately proven to be groundless, allegations against us could severely impact our business, and any investment in the Common Stock, and our Warrants could be greatly reduced or even rendered worthless.
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, the market price for the Common Stock and trading volume could decline.
The trading market for the Common Stock will depend in part on the research and reports that securities or industry analysts publish about us or our business. If research analysts do not establish and maintain adequate research coverage or if one or more of the analysts who covers us downgrades the Common Stock, and/or our Warrants or publishes inaccurate or unfavorable research about our business, the market price for the securities would likely decline. If one or more of these analysts ceases coverage of our Company or fails to publish reports on us regularly, we could lose visibility in the financial markets, which, in turn, could cause the market price or trading volume for the Common Stock, and/or our Warrants to decline.
We may be subject to securities litigation, which is expensive and could divert our management’s attention.
The market price of our securities may be volatile, and in the past companies that have experienced volatility in the market price of their securities have been subject to securities class action litigation. We may be the target of this type of litigation in the future. Securities litigation against us could result in substantial costs and divert our management’s attention from other business concerns, which could seriously harm our business.
We may issue preferred stock with terms that could adversely affect the voting power or value of our Common Stock.
Our amended certificate of incorporation authorizes us to issue, without the approval of our stockholders, one or more classes or series of preferred stock having such designations, preferences, limitations and relative rights, including preferences over our Common Stock with respect to dividends and distributions, as our board of directors may determine. The terms of one or more classes or series of preferred stock could adversely impact the voting power or value of our Common Stock. For example, we might grant holders of preferred stock the right to elect some number of our directors in all events or upon the happening of specified events or the right to veto specified transactions. Similarly, the repurchase or redemption rights or liquidation preferences we might assign to holders of preferred stock could affect the residual value of our Common Stock.
Since we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, stock price appreciation, if any, will be your sole source of gain.
We currently intend to retain all of our future earnings, if any, to finance the growth and development of our business. In addition, the terms of any future debt agreements may preclude us from paying dividends. As a result, appreciation, if any, in the market price of our Common Stock will be your sole source of gain for the foreseeable future.
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We may need additional capital, and we may be unable to obtain such capital in a timely manner or on acceptable terms, or at all. Furthermore, our future capital needs may require us to sell additional equity or debt securities that may dilute our stockholders or introduce covenants that may restrict our operations or our ability to pay dividends.
To grow our business and remain competitive, we may require additional capital from time to time for our daily operation. In addition to the proceeds of this annual report, we may continue to seek capital through private placement transactions. Our ability to obtain additional capital is subject to a variety of uncertainties, including:
| ● | our market position and competitiveness in our industry; | |
| ● | our future profitability, overall financial condition, results of operations and cash flows; and | |
| ● | economic, political and other conditions in the U.S. |
We may be unable to obtain additional capital in a timely manner or on acceptable terms or at all. In addition, our future capital needs and other business reasons could require us to sell additional equity or debt securities or obtain a credit facility. The sale of additional equity or equity-linked securities could dilute our stockholders. The incurrence of indebtedness would result in increased debt service obligations and could result in operating and financing covenants that would restrict our operations or our ability to pay dividends to our stockholders.
Our existing stockholders have substantial influence over our Company and their interests may not be aligned with the interests of our other stockholders, which may discourage, delay or prevent a change in control of our Company, which could deprive our stockholders of an opportunity to receive a premium for their securities.
As of the date of this prospectus, certain stockholders of management control an aggregate majority of voting power in us. As a result, these stockholders have substantial influence over our business, including decisions regarding mergers, consolidations and the sale of all or substantially all of our assets, election of directors and other significant corporate actions. This concentration of ownership may discourage, delay or prevent a change in our control, which could deprive our stockholders of an opportunity to receive a premium for their shares as part of any contemplated sale of our Company and may reduce the price of our Common Stock.
Item 1B. Unresolved Staff Comments
Not applicable to a smaller reporting company.
Item 1C. Cybersecurity.
Risk Management and Strategy
We have implemented and maintain
various information security processes designed to identify, assess and manage material risks from cybersecurity threats to our critical
computer networks,
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Our officers and our IT vendors help identify, assess and manage our cybersecurity threats and risks. We manage, identify and assess risks from cybersecurity threats by monitoring and evaluating our threat environment and risk profile using various methods including, for example: through the use of automated tools, including but not limited to tools for monitoring, geolocation, remote wiping, threat detection, intrusion detection and prevention (including through the use of machine learning, a form of artificial intelligence), patch management, distributed denial of service (DDoS) protection and forensics; conducting (directly or through third parties) regular audits and threat assessments for internal and external threats; subscribing to reports and services that identify cybersecurity threats; analyzing reports of threats and actors; conducting vulnerability assessments to identify vulnerabilities; evaluating our and our industry’s risk profile; conducting tabletop incident response exercises; and evaluating threats reported to us.
Depending on the environment, we implement and maintain various technical, physical, and organizational measures, processes, standards and policies designed to manage and mitigate material risks from cybersecurity threats to our Information Systems and Data, including, for example: incident response plans and procedures, disaster recovery/business continuity plans, risk assessments, implementation of security standards and certifications, encryption of data, network security controls, data segregation, access controls, physical security, asset management, tracking and disposal, systems monitoring, vendor risk management program, employee training and penetration testing.
Our assessment and management
of material risks from cybersecurity threats are
We use
We use third-party service providers to perform a variety of functions throughout our business, including but not limited to application providers, hosting companies, contract manufacturing organizations and contract research organizations. We have a vendor management program to oversee, identify and manage cybersecurity risks associated with our use of these providers. The program includes a risk assessment for vendors that may include, depending on the vendor and nature of services being performed, security questionnaires, review of the vendor’s written security program, review of security assessments, audits and reports, vulnerability scans related to the vendor, security assessment calls with the vendor’s security personnel, and the imposition of certain contractual obligations on the vendor, among other elements, in accordance with the processes outlined in our internal vendor selection, management, and oversight process policy and other internal guidelines. More specifically, the level of assessment may depend on the following: the nature of the services provided and the data the vendors may collect, retain, and utilize, the sensitivity of the Information Systems and Data at issue, and the identity of the provider.
Governance
Our board of directors addresses our cybersecurity risk management as part of its general oversight function. Commencing after our uplisting, our Audit Committee, on behalf of the board of directors, will provide oversight of our cybersecurity risk management program.
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Certain members of our management team are responsible for hiring appropriate personnel, helping to integrate cybersecurity risk considerations into our overall risk management strategy, communicating key priorities to relevant personnel, approving budgets, helping prepare for cybersecurity incidents, approving cybersecurity processes, and reviewing security assessments and other security-related reports.
Our cybersecurity incident response processes are designed to escalate certain cybersecurity incidents to members of management. Our cybersecurity incident management team, and other individuals as needed, work to help us mitigate and remediate cybersecurity incidents of which we are notified. In addition, our incident response processes include a procedure for reporting certain cybersecurity incidents to the board of directors.
The board of directors receives regular reports from management concerning our cybersecurity risk management program. The board also receives various summaries and/or presentations related to cybersecurity threats, risks and mitigation.
Item 2. Properties
We own no real property interest. The Company leases a small office that is sufficient for our current operations at a monthly rental of $100. We intend to lease additional office space as our needs require.
Item 3. Legal Proceedings
From time to time, we may become involved in litigation or other legal proceedings. We are not currently a party to any material litigation or legal proceedings. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors. We currently have no pending legal or administrative proceedings.
Item 4. Mine Safety Disclosures
Not applicable.
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PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Market Information
Our common stock is currently quoted on the OTC PINK tier of the OTC Markets under the symbol “LUDG.” Trading in OTC PINK stocks can be volatile, sporadic and risky, as thinly traded stocks tend to move more rapidly in price than more liquid securities. Such trading may also depress the market price of our common stock and make it difficult for our stockholders to resell their common stock.
The following table reflects the high and low closing price for our common stock for the periods indicated. The information was obtained from the OTC Markets Group, Inc. and reflects inter-dealer prices, without retail mark-up, markdown or commission, and may not necessarily represent actual transactions.
| Year Ended December 31, 2025 | ||||||||
| March 31, 2025 | $ | 0.150 | $ | 0.110 | ||||
| June 30, 2025 | $ | 0.135 | $ | 0.059 | ||||
| September 30, 2025 | $ | 0.090 | $ | 0.042 | ||||
| December 31, 2025 | $ | 0.042 | $ | 0.065 | ||||
| Year Ended December 31, 2024 | ||||||||
| March 31, 2024 | $ | 0.071 | $ | 0.290 | ||||
| June 30, 2024 | $ | 0.130 | $ | 0.300 | ||||
| September 30, 2024 | $ | 0.102 | $ | 0.280 | ||||
| December 31, 2024 | $ | 0.111 | $ | 0.230 | ||||
On March 11, 2026, the closing price of our Common Stock was $0.039
Penny Stock
The SEC has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a market price of less than $5.00, other than securities registered on certain national securities exchanges or quoted on the NASDAQ system, provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock, to deliver a standardized risk disclosure document prepared by the SEC, that: (a) contains a description of the nature and level of risk in the market for penny stocks in both public offerings and secondary trading; (b) contains a description of the broker’s or dealer’s duties to the customer and of the rights and remedies available to the customer with respect to a violation of such duties or other requirements of the securities laws; (c) contains a brief, clear, narrative description of a dealer market, including bid and ask prices for penny stocks and the significance of the spread between the bid and ask price; (d) contains a toll-free telephone number for inquiries on disciplinary actions; (e) defines significant terms in the disclosure document or in the conduct of trading in penny stocks; and (f) contains such other information and is in such form, including language, type size and format, as the SEC shall require by rule or regulation.
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The broker-dealer also must provide, prior to effecting any transaction in a penny stock, the customer with (a) bid and offer quotations for the penny stock; (b) the compensation of the broker-dealer and its salesperson in the transaction; (c) the number of shares to which such bid and ask prices apply, or other comparable information relating to the depth and liquidity of the market for such stock; and (d) a monthly account statement showing the market value of each penny stock held in the customer’s account.
In addition, the penny stock rules require that prior to a transaction in a penny stock not otherwise exempt from those rules, the broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written acknowledgment of the receipt of a risk disclosure statement, a written agreement as to transactions involving penny stocks, and a signed and dated copy of a written suitability statement.
These disclosure requirements may have the effect of reducing the trading activity for our common stock. Therefore, shareholders may have difficulty selling our securities.
Holders of Our Common Stock
As of March 11, 2026, we had 162,569,807 outstanding shares of common stock and approximately 620 shareholders of record.
Dividends
There are no restrictions in our Articles of Incorporation, as amended, or Bylaws that prevent us from declaring dividends. The payment of dividends on common stock is at the discretion of our Board of Directors. The Nevada Revised Statutes, however, do prohibit us from declaring dividends where, after giving effect to the distribution of the dividend: (1) we would not be able to pay our debts as they become due in the usual course of business; or (2) our total assets would be less than the sum of our total liabilities plus the amount that would be needed to satisfy the rights of shareholders who have preferential rights superior to those receiving the distribution.
We currently do not anticipate paying any dividends in the foreseeable future.
Recent Sales of Unregistered Securities
During the year ended December 31, 2025, we issued no unregistered securities that have not been previously reported.
Subsequent to December 31, 2025, we issued no unregistered securities that have not been previously reported.
Purchases of Equity Securities by the Issuer and Affiliated Purchasers
None.
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Item 6. [Reserved]
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Forward-looking Statements
There are “forward looking statements” contained herein. All statements that express expectations, estimates, forecasts or projections are forward-looking statements. In addition, other written or oral statements which constitute forward-looking statements may be made by us or on our behalf. Words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “estimate,” “project,” “forecast,” “may,” “should,” and variations of such words and similar expressions are intended to identify such forward-looking statements. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in or suggested by such forward-looking statements. We undertake no obligation to update or revise any of the forward-looking statements after the date of this annual report to conform forward-looking statements to actual results. Important factors on which such statements are based are assumptions concerning uncertainties, including but not limited to, uncertainties associated with the following:
| ● | Inadequate capital and barriers to raising the additional capital or to obtaining the financing needed to implement our business plans; | |
| ● | Our failure to earn revenues or profits; | |
| ● | Inadequate capital to continue business; | |
| ● | Volatility or decline of our stock price; | |
| ● | Potential fluctuation in annual results; | |
| ● | Rapid and significant changes in markets; | |
| ● | Litigation with or legal claims and allegations by outside parties; and | |
| ● | Insufficient revenues to cover operating costs. |
The following discussion should be read in conjunction with the financial statements and the notes thereto which are included in this annual report. This discussion contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ substantially from those anticipated in any forward-looking statements included in this discussion as a result of various factors.
Overview
We are an innovative technology and health related Company that is developing products that use mRNA-based genetic markers with the potential to measure the presence of inflammation, and, as a result, inflammatory driven diseases and monitor patient response to treatment. Advancements in medical technology have awarded us with cutting edge genetic tools, unheard of even a generation ago. These genetic tools have the potential to not only achieve early detection of diseases but also to support customized treatments that may improve patient outcomes. The Company is at the forefront of this new era of medicine with development of products that will embody our proprietary mRNA genomic technology that has the potential of detecting genetic biomarkers for inflammatory driven diseases, including, but not limited to, heart disease, diabetes, preeclampsia, cancer and “long COVID”.
Current Financial Condition Summary
We have not yet derived revenues from our operations.
We had a net loss of $2,236,433 for the year ended December 31, 2025. Additionally, we had net cash used in operating activities of $644,842 for the year ended December 31, 2025. At December 31, 2025, we had a working capital deficit of $4,397,372, an accumulated deficit of $9,495,799 and a stockholders’ deficit of $4,388,206, which could have a material impact on our ability to obtain needed capital.
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Implications of Being an Emerging Growth Company
We qualify as an “emerging growth company” under the JOBS Act. As a result, we are permitted to, and intend to, rely on exemptions from certain disclosure requirements. For so long as we are an emerging growth company, we will not be required to:
| ● | have an auditor report on our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act; | |
| ● | comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (i.e., an auditor discussion and analysis); | |
| ● | submit certain executive compensation matters to shareholder advisory votes, such as “say-on-pay” and “say-on- frequency;” and | |
| ● | disclose certain executive compensation related items such as the correlation between executive compensation and performance and comparisons of the CEO’s compensation to median employee compensation. |
In addition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of the benefits of this extended transition period. Our financial statements may therefore not be comparable to those of companies that comply with such new or revised accounting standards.
We will remain an “emerging growth company” for up to five years, or until the earliest of (i) the last day of the first fiscal year in which our total annual gross revenues exceed $1.07 billion, (ii) the date that we become a “large accelerated filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, which would occur if the market value of our ordinary shares that is held by non-affiliates exceeds $700 million as of the last business day of our most recently completed second fiscal quarter or (iii) the date on which we have issued more than $1 billion in non-convertible debt during the preceding three year period.
Results of Operations
Year Ended December 31, 2025, compared to the Year Ended December 31, 2024.
Revenue. For the years ended December 31, 2025 and 2024, we had revenues of $0 and $217, respectively. We believe that revenues from sales of our planned products will begin during the second or third quarter of 2026, assuming we are able to obtain needed funding, of which there is no assurance.
Operating Expenses. Total operating expenses for the years ended December 31, 2025 and 2024, were $1,774,680 and $1,298,406, respectively. The increase in operating expenses during the year ended December 31, 2025, was primarily due to an increase in our activities relating to our planned products, including development of our proprietary software, website and product packaging, as well as the payment of monthly fees to our key consultants and fees for professional services, including accounting and legal, and an increase in our research and development expenses.
General and Administrative Expenses. The increase of $410,301 in general and administrative expenses, from $1,132,785 for the year ended December 31, 2024, as compared to $1,543,086 for the year ended December 31, 2025, was primarily due to the increase in our activities relating to our planned products, including development of our website and product packaging, as well as the payment of monthly fees to our key consultants and fees for professional services, including accounting and legal.
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Research and Development. The increase of $65,972 in research and development expenses to $231,593 from $165,621 for the years ended December 31, 2025 and 2024, respectively, was due to our determining to make expenditures in the development of our planned products, including the payment of product study-related expenses. While we expect to continue to incur research and development expenses, we are unable to predict the level of such expenditures, due to the uncertainty of the level of funding that will be available to us.
Other Income/Expense. The decrease of $1,291,745 in total other expense to $461,753 from $1,753,498 for the years ended December 31, 2025 and 2024, respectively, was primarily due to an increase in interest income, change in fair value of derivative liabilities and other income and a decrease in inducement expenses and finance expenses, offset by an increase in interest expenses, loss on debt extinguishment and amortization of debt discount, offset by a reduction in inducement expenses and finance expenses.
Inducement Expense Inducement Expense for the year ended December 31, 2025, was $0 compared to $1,004,574 for the year ended December 31, 2024. The significant decrease was a result of no additional consideration given for the extensions of our OID and convertible notes.
Finance Expense Finance Expenses for the year ended December 31, 2025, was $0 for the year ended December 31, 2024, compared to $677,130 for the year ended December 31, 2024. The significant decrease was related to the issuance of warrants during the year ended December 31, 2024, but none during the year ended December 31, 2025.
Interest Expense. Interest expense for the year ended December 31, 2025, was $91,922 for the year ended December 31, 2024, compared to $56,794 for the year ended December 31, 2024. The increase is due to the issuance of convertible promissory notes during the year.
Amortization of Debt Discount. During the year ended December 31, 2025, we incurred amortization of debt discount expense of $796,276 as compared to $15,000 for the year ended December 31, 20224, for OID and guaranteed interest on convertible notes payable.
Liquidity and Capital Resources
At December 31, 2025, the Company had $0 in cash and a working capital deficit of $4,397,372, compared to $6,741 in cash and a working capital deficit of $2,378,145 at December 31, 2024. The Company does not have sufficient working capital to fund current operating expenses at least through the first quarter of 2026 and will require additional funds. We will need to obtain additional debt or equity-based capital from third parties to implement our full business plans. There is no assurance that we will be successful in obtaining such additional capital.
Cash Flows
Net Cash Used in Operating Activities. We did not generate positive cash flows from operating activities during the years ended December 31, 2025, and 2024.
Cash flows used in operating activities for the year ended December 31, 2025, were comprised of a net loss of $2,236,433 reduced by non-cash expenses of $598,536. Non-cash expenses were primarily composed of stock issued for services, amortization of debt discount, change in fair value of derivative liability and loss on extinguishment of debt. Cash flows of $993,055 were also produced by the changes in the levels of operating assets and liabilities, primarily related to an increase in prepaid expenses and accounts payable and accrued expenses, and a decrease in inventory.
Cash flows used in operating activities for the year ended December 31, 2024, were comprised of a net loss of $3,016,884, reduced by non-cash expenses of $1,911,985. Non-cash expenses were primarily composed of stock issued for services, stock issued for research and development, amortization of debt discount, and inducement expenses related to extending our convertible and OID notes and loss on sale of a subsidiary. Cash flows of $444,597 were also used by the changes in the levels of operating assets and liabilities, primarily related to an decrease in prepaid expenses and other assets, offset primarily by an increase in accounts payable and accrued expenses.
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Net Cash Used in Investing Activities. Net cash used in investing activities was $9,166 during the year ended December 31, 2025, was comprised of investment in intellectual property, compared to $0 during the year ended December 31, 2024.
Net Cash Provided by Financing Activities. During the year ended December 31, 2025, cash provided by financing activities of $647,267 included $750,000 from the proceeds from convertible notes payable, $61,024 in proceeds from related parties and $1,252 increase in bank overdraft, offset by $52,951 in deferred offering costs, $12,058 in repayments to related parties and $100,000 used to repay a note payable.
During the year ended December 31, 2024, cash provided by financing activities of $558,708 included $618,708 from the proceeds from convertible notes payable, a $50,000 cash advance from an investor and $5,000 in advance from a related party, offset by $60,000 in deferred offering costs, and $55,000 in repayments of a convertible note and guaranteed interest.
Going Concern
The consolidated financial statements beginning on page F-1 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. As reflected in the financial statements, we had a working capital deficit of $4,397,372 at December 31, 2025, and had a net loss from continuing operations of $2,236,433 for the year December 31, 2025, which raises substantial doubt as to the Company’s ability to continue as a going concern for a period of one year from the issuance of the financial statements.
Off Balance Sheet Arrangements
At December 31, 2025, we did not have any off balance sheet arrangements that we believe have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenue or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.
Critical Accounting Policies
Our accounting policies are more fully described in our financial statements, beginning on page F-1. The preparation of financial statements in conformity with generally accepted accounting principles in the United States requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Although these estimates are based on our best knowledge of current and anticipated events, actual results could differ from the estimates.
We have identified the following accounting policies as those that require significant judgments, assumptions and estimates and that have a significant impact on our financial condition and results of operations. These policies are considered critical because they may result in fluctuations in our reported results from period to period, due to the significant judgments, estimates and assumptions about complex and inherently uncertain matters and because the use of different judgments, assumptions or estimates could have a material impact on our financial condition or results of operations. We evaluate our critical accounting estimates and judgments required by our policies on an ongoing basis and update them as appropriate based on changing conditions.
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Fair Value of Financial Instruments. The Company accounts for financial instruments under Financial Accounting Standards Board (“FASB”) ASC 820, Fair Value Measurements. ASC 820 provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability.
The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires the Company to use observable inputs when available, and to minimize the use of unobservable inputs, when determining fair value.
The three tiers are defined as follows:
Level 1 - Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets;
Level 2 - Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and
Level 3 - Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions.
The determination of fair value and the assessment of a measurement’s placement within the hierarchy requires judgment. Level 3 valuations often involve a higher degree of judgment and complexity. Level 3 valuations may require the use of various cost, market, or income valuation methodologies applied to unobservable management estimates and assumptions. Management’s assumptions could vary depending on the asset or liability valued and the valuation method used. Such assumptions could include estimates of prices, earnings, costs, actions of market participants, market factors, or the weighting of various valuation methods. The Company may also engage external advisors to assist us in determining fair value, as appropriate.
Beneficial Conversion Features. For instruments that are not considered liabilities under ASC 480 or ASC 815, the Company applies ASC 470-20 to convertible securities with beneficial conversion features that must be settled in stock. ASC 470-20 requires that the beneficial conversion feature be valued at the commitment date as the difference between the effective conversion price and the fair market value of the common stock (whereby the conversion price is lower than the fair market value) into which the security is convertible, multiplied by the number of shares into which the security is convertible limited to the amount of the loan. This amount is recorded as a debt discount and amortized to interest expense in the Consolidated Statements of Operations.
Debt Discount. For certain notes issued, the Company may provide the debt holder with an original issue discount. The original issue discount is recorded as a debt discount, reducing the face amount of the note, and is amortized to interest expense over the life of the debt, in the Consolidated Statements of Operations.
The Company adopted ASU 2020-06 on January 1, 2024, which eliminated the cash conversion sub-sections of ASC 470-20 resulting in these instruments being recorded as a single liability. As a result, the discount created by recognition of a component of the convertible debt in equity was eliminated and interest expense was reduced. When adopted, the Company recorded the change to retained earnings.
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Research and Development. The Company accounts for research and development costs in accordance with ASC subtopic 730-10, Research and Development (“ASC 730-10”).
Under ASC 730-10, all research and development costs must be charged to expense as incurred. Accordingly, internal research and development costs are expensed as incurred. Third-party research and development costs are expensed when the contracted work has been performed or as milestone results have been achieved as defined under the applicable agreement. Company-sponsored research and development costs related to both present and future products are expensed in the period incurred.
Stock-based Compensation. The Company accounts for our stock-based compensation under ASC 718 “Compensation - Stock Compensation” using the fair value-based method. Under this method, compensation cost is measured at the grant date based on the value of the award and is recognized over the service period, which is usually the vesting period. This guidance establishes standards for the accounting for transactions in which an entity exchanges it equity instruments for goods or services. It also addresses transactions in which an entity incurs liabilities in exchange for goods or services that are based on the fair value of the entity’s equity instruments or that may be settled by the issuance of those equity instruments.
The Company uses the fair value method for equity instruments granted to non-employees and use the Black-Scholes model for measuring the fair value of options.
The fair value of stock-based compensation is determined as of the date of the grant or the date at which the performance of the services is completed (measurement date) and is recognized over the vesting periods.
When determining fair value, the Company considers the following assumptions in the Black-Scholes model:
| ● | Exercise price, | |
| ● | Expected dividends, | |
| ● | Expected volatility, | |
| ● | Risk-free interest rate; and | |
| ● | Expected life of option |
Recently Issued Accounting Pronouncements. Changes to accounting principles are established by the FASB in the form of Accounting Standards Updates (“ASU’s”) to the FASB’s Codification. We consider the applicability and impact of all ASU’s on our financial position, results of operations, stockholders’ deficit, cash flows, or presentation thereof. Management has evaluated all recent accounting pronouncements as issued by the FASB in the form of Accounting Standards Updates (“ASU”) through the date these financial statements were available to be issued and found the following recent accounting pronouncements issued, but not yet effective accounting pronouncements, are not expected to have a material impact on the financial statements of the Company.
In November 2024, the FASB issued ASU 2024-03, ASC Subtopic “Disaggregation of Income Statement Expenses (ASC 220-40): Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures”. The amendments require additional disclosure of the nature of expenses included in the income statement. The amendments in this update are effective for public business entities for fiscal years, beginning after December 15, 2026. Early adoption is permitted. The Company is currently assessing the impact of the adoption of this standard on its consolidated financial statements.
We do not expect the adoption of this pronouncement will have a material effect on the Company’s financial statements.
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Item 7A. Quantitative and Qualitative Disclosures about Market Risk
Not applicable to a smaller reporting company.
Item 8. Financial Statements and Supplementary Data
Please see our Financial Statements beginning on page F-1 of this Annual Report.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
During the years ended December 31, 2025 and 2024, there were no changes, in or disagreements with, our independent auditor.
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports filed pursuant to the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the Commission’s rules and forms and that such information is accumulated and communicated to our management, including our President and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
As required by Exchange Act Rule 13a-15(e), we carried out an evaluation, under the supervision and with the participation of our management, including our Interim Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures. Based on that evaluation, our President and our Chief Financial Officer concluded that our disclosure controls were not effective at December 31, 2025.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) under the Exchange Act. Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Our internal control over financial reporting includes those policies and procedures that:
| ● | pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets; | |
| ● | provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and | |
| ● | provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements. |
As an emerging growth company experiencing rapid growth, we have worked diligently to improve processes within our company that increase risk related to transaction processing which can impact our financial reporting. We intend to implement a significant number of manual compensating controls to address this risk.
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Because of the 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. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Because of the inherent limitations of internal control, there is a risk that material misstatements may not be prevented or detected on a timely basis by internal control over financial reporting. However, these inherent limitations are known features of the financial reporting process. Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this risk.
Our management, including our Interim Chief Executive Officer and our Chief Financial Officer, assessed the effectiveness of our internal control over financial reporting as of December 31, 2025. In making this assessment, our management used the criteria set forth by the Committee of Sponsoring Organizations of the 2013 Treadway Commission (“COSO”) in Internal Control-Integrated Framework. Based on that evaluation, they concluded that, during the period covered by this Annual Report, such internal controls and procedures were not effective.
This Annual Report on Form 10-K does not include an attestation report by our company’s registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by our company’s registered public accounting firm pursuant to the rules of the SEC that require our company to provide only our company’s management’s report in this Annual Report on Form 10-K.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting during our last fiscal year that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information
Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections
Not applicable.
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PART III
Item 10. Directors, Executive Officers and Corporate Governance
The following table sets forth the names and ages of our company’s current directors and executive officers.
Below is a list of our executive officers and directors as of the date of this prospectus.
| Name | Age | Position | ||
| Jose Antonio Reyes | 60 | Interim Chief Executive Officer | ||
| Scott Silverman | 56 | Chief Financial Officer and Director | ||
| Marvin S. Hausman, M.D. | 83 | Chief Science Officer | ||
| Garth Lees-Rolfe | 41 | Director | ||
| Corain McGinn | 56 | Director |
Our directors serve until the earlier occurrence of the election of his or her successor at the next meeting of shareholders, death, resignation or removal by the Board of Directors. Officers serve at the discretion of our Board of Directors. There are no family relationships between or among our directors and executive officers.
Certain information regarding the backgrounds of our officers and director is set forth below.
Jose Antonio Reyes has served as our Interim Chief Executive Officer since October 1, 2025. Previously, he served as our Chief Executive Officer from September 2024 until his resignation in April 2025. During the period of April 2025 until his appointment as Interim CEO in October 2025, Mr. Reyes served us in a non-executive position. Prior to becoming our Chief Executive Officer, Mr. Reyes served as our Chief Operating Officer from February 2023 until taking over as our Chief Executive Officer in September 2024. From 2017 through 2023, Mr. Reyes served as Director of Executive Relations & Business Development for BlockScience, Inc., where his duties included overseeing the development of internal communications, hiring, monitoring and quality control systems. Mr. Reyes has over 30 years of leadership experience across national and international markets. Previously, Mr. Reyes co-founded and led IGM Global Inc., an executive education media company that provides insights into disruptive technologies and their industry impacts. He also founded Excelorators, Inc., offering corporate leadership development programs at prestigious institutions such as Harvard, MIT, Stanford, and West Point. Additionally, he was the Chief Strategy Officer for Trademark Tours, which specializes in private hospitality and customized education services at Harvard University. Mr. Reyes holds an MA in Communication and Media Studies and an MA in Biblical Studies from Regent University, along with a BA in Public Policy-Telecommunications from Duke University.
Scott J. Silverman has served as our Chief Financial Officer and a director since November 2023. Mr. Silverman has over 30 years of business success on national and international levels, with a highly diverse knowledge of financial, legal and operations management; public company management, accounting and SEC regulations. Mr. Silverman is one of the founders, and since 2007, has served and currently serves as President and CEO of Thornhill Advisory Group, Inc., a multi-national corporate financial management and advisory firm serving clients around the world, and since 2021, has served and currently serves as the CEO of Thornhill Holdings, Ltd, a private equity firm that focuses its investments in the hospitality, technology, construction, real estate and healthcare sectors. Mr. Silverman is also a director nominee of Muliang Viagoo Technology, Inc. (OTC:MULG). From November 2023 to September 2024, he served as the CFO of Vocodia Holdings, Inc (OTC:VHAI), a publicly traded artificial intelligence software company, and from August 2021 through April 2022 as the CFO of Sidus Space, Inc., (NASDAQ:SIDU), a publicly traded Space-as-a-Service company, both of which in his capacities, he oversaw their IPOs. From October 2018 through February 2024, Mr. Silverman also served as the CFO of Healthsnap, Inc. a healthcare Software as a Service (SaaS) platform on the cutting edge of remote patient monitoring and chronic care management and from November 2018 through February 2023 as the CFO of Riverside Miami, LLC, a mixed-use restaurant and entertainment project in Miami, Florida. He has a bachelor’s degree in finance from George Washington University and a master’s degree in accounting from NOVA Southeastern University. We believe that Mr. Silverman is qualified to serve on our board by reasons of the above-mentioned professional experiences and qualifications, specifically as it relates to financial management, accounting controls and financial strategy.
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Marvin S. Hausman, M.D. has served as our Chief Science Officer since September 5, 2023 and served as our Chief Executive Officer from September 2023 through August 2024, and a key consultant to our company from July 2022 until September 2023 and as a director from November 2023 until June 2025. In the five years prior to joining Ludwig, Dr. Hausman served as a consultant with various life science companies including Nova Mentis Life Science, Summit Joint Performance and Designer Genomics. Dr. Hausman is an Immunologist and Board-Certified Urological Surgeon with more than 40 years of drug research and development experience with various pharmaceutical companies, including Bristol Myers International, Mead Johnson Pharmaceutical Co., E.R. Squibb, Medco Research, and Axonyx. An accomplished executive with domestic and international experience, Dr. Hausman successfully executed acquisitions of breakthrough medical technology, in conjunction with formation, funding and launch of several corporations. He is a co-founder of Medco Research Inc., a NYSE biopharmaceutical company acquired by King Pharmaceutical Inc, currently a division of Pfizer. He is a founder of Axonyx Inc., acquired by Torrey Pines Therapeutics, Inc. He is a founder of Entia Biosciences, Inc., which designs and develops natural organic antioxidant food-based products to be used as nutritional supplements in humans and animals. He is founder and President of Northwest Medical Research Partners, Inc., a company specializing in the identification and acquisition of breakthrough pharmaceutical and nutraceutical products. Dr. Hausman is a Member of the Board of Governors of New York University School of Medicine Alumni Association. Dr. Hausman received his medical degree from New York University School of Medicine in 1967.
Garth Lees-Rolfe was appointed to our Board of Directors on June 23, 2025, as an independent director. Mr. Lees-Rolfe has over 20 years of experience in finance, accounting and strategic financial planning. Mr. Lees-Rolfe is the current CFO of ABLi Therapeutics, Inc., a private clinical-stage biotech company and has been since April 2025. Previously Garth was the CFO of Inhibikase Therapeutics, Inc., (NASDAQ: IKT) a publicly traded global clinical-stage biotech company from April 2024 to April 2025 and the VP of Finance from November 2022 to April 2024. Mr. Lees-Rolfe previously served as the Vice-President, Finance for F-Star, Inc., (NASDAQ: FSTX) a publicly traded global clinical-stage biotech company from December 2021 to November 2022. Prior to that, Mr. Lees-Rolfe worked for 16 years in public practice, most of which was with Ernst & Young, most recently as Senior Manager from 2016 to 2021. Mr. Lees-Rolfe earned a Bachelor of Business from the Queensland University of Technology and a Graduate Certificate in Applied Finance from Kaplan Professional. He is a licensed Certified Public Accountant in the state of Massachusetts and a licensed Chartered Accountant of Australia and New Zealand. We believe Mr. Lees-Rolfe is qualified to serve on our board by reasons of the above-mentioned professional experiences and qualifications, specifically as it relates to financial management and business strategy.
Corain McGinn was appointed to our Board of Directors on September 5, 2025, as an independent director Mr. McGinn is an experienced and effective executive with many years working around the globe with both Fortune 100 and emerging companies in technology, pharmaceutical and biotechnology. His focus is on bringing comprehensive and creative solutions that drive impact and revenue. He has worked at the executive level of, for example, Advanced Micro Devices Inc., Microsoft Corp, Merck & Co. (including Merck Research Labs, Merck Latin America, Merck Australia), Novartis AG, Schering-Plough Corporation, Hitachi Ltd. (including Hitachi Data Systems, Hitachi Industrial, and Hitachi Medical), in addition to hundreds of less well known but market leading and innovative companies His work has ranged from providing high-level strategic vision and priorities to drive and create markets; to developing multi-year strategic plans for the use of information technology to improve the pharma research and development process from compound discovery through final clinical studies and FDA approval; and, to designing competitive pricing structures for entry of new pharmaceuticals and technology into crowded markets to gain market share advantages. He currently assists companies who are growing, restructuring, and transforming for the new market paradigms. Mr. McGinn is a licensed attorney in New York and Massachusetts, and also holds a Masters of Business Administration (MBA) in Strategy and Marketing from The McDonagh School of Business at Georgetown University in Washington, DC. He also holds a Joint Honors Bachelor of Laws in Law and Accounting from The Queens University of Belfast, in Northern Ireland. We believe Mr. McGinn is qualified to serve on our board by reasons of the above-mentioned professional experiences and qualifications, specifically as it relates to pharmaceuticals and biotechnology.
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Key Consultant
Kyle Ambert, PhD. Dr. Ambert is currently Director of Data Science at Nike, Inc. and has extensive experience in data analytics, machine learning, artificial intelligence and applied analytics. His previous experience includes postings with the National Library of Medicine and Intel Corp. Dr. Ambert holds a PhD in Biomedical Informatics from Oregon Health & Science University.
Additionally, Dr. Ambert has interests in the following: applied analytics, multivariate statistics, machine learning and deep learning, text mining and natural language processing, biomedical informatics, distributed computing, information visualization, and behavioral economics. These interests give him skills in technical communication, data analysis, data visualization, analytics, programing, deep learning frameworks, and health and life sciences, all of which we believe are of great value to the Company.
Under our consulting agreement dated July 1, 2022, with Dr. Ambert, we pay Dr. Ambert $2,500 per month. In addition, we issued Dr. Ambert 250,000 shares of our Common Stock upon his entering into the agreement. Dr. Ambert provides us with Biomedical Informatics Services, which includes developing data mining tools to quantitate, analyze and perform cluster analysis of DNA and RNA panels. The agreement is for a term of one year, which renews for additional one-year periods, unless either party elects not to renew the agreement. Kyle was issued a bonus in shares on the filing of our most recent patent showing bladder, breast and colon cancer data.
Conflicts of Interest
Our executive officers, our sole director and our key consultant are engaged in other businesses, either individually or through partnerships and corporations in which they may have an interest, hold an office or serve on a board of directors. As a result, certain conflicts of interest may arise. We will attempt to resolve such conflicts of interest in favor of our company. In general, our officers and directors are accountable to us and our shareholders as fiduciaries, which requires that these officers and directors exercise good faith and integrity in handling our company’s affairs. A shareholder may be able to institute legal action on behalf of our company or on behalf of itself and other similarly situated shareholders to recover damages or for other relief in cases of the resolution of conflicts is in any manner prejudicial to us.
Involvement in Certain Legal Proceedings
From time to time, we may become involved in litigation or other legal proceedings. We are not currently a party to any material litigation or legal proceedings. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
Code of Business Conduct and Ethics
On January 2, 2025, the board of directors adopted a Business Code of Ethics that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. Our Business Code of Ethics is filed as an exhibit to this annual report.
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Corporate Governance
We do not have a separate Compensation Committee, Audit Committee or Nominating Committee. These functions are conducted by our entire Board of Directors. During the year ended December 31, 2025, our Board of Directors did not hold a meeting, but instead took actions by written consent in lieu of a meeting.
There are no understandings between the Directors of the Company or any other person pursuant to which our officers and directors were or are to be selected as an officer or director.
Independence of Board of Directors
Our board of directors has determined that Garth Lees-Rolfe and Corain McGinn are independent, within the meaning of definitions established by the SEC or any self-regulatory organization. We are not currently subject to any law, rule or regulation requiring that all or any portion of our Board of Directors include independent directors.
Shareholder Communications with Our Board of Directors
The Company welcomes comments and questions from our shareholders. Shareholders should direct all communications to our Interim Chief Executive Officer, Jose Antonio Reyes, at our executive offices. However, while we appreciate all comments from shareholders, we may not be able to respond individually to all communications. We will attempt to address shareholder questions and concerns in our press releases and documents filed with the SEC, so that all shareholders have access to information about us at the same time. Mr. Reyes collects and evaluates all shareholder communications. All communications addressed to our directors and executive officers will be reviewed by those parties, unless the communication is clearly frivolous.
Insider Trading Policy
On March 27, 2025, the Company
Item 11. Executive Compensation
In General
Currently, our management is unable to estimate accurately when, if ever, our company will possess sufficient capital, whether derived from sales revenues, this annual report or otherwise, for the payment of salaries to our management.
As of the date of this Annual Report, there are no annuity, pension or retirement benefits proposed to be paid to officers, directors or employees of our company, pursuant to any presently existing plan provided by, or contributed to, our company.
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Compensation Summary
The following table summarizes information concerning the compensation awarded, paid to or earned by, our named executive officers during the years ended December 31, 2025 and 2024.
| Name and Principal Position | Year Ended 12/31 | Salary ($) | Bonus ($) | Stock Awards ($) | Option Awards ($) | Non-Equity Incentive Plan Compensation ($) | Non-qualified Deferred Compensation Earnings ($) | All Other Compensation ($) | Total ($) | |||||||||||||||||||||||||||
| Jose Antonio Reyes(1) | 2025 | 105,000 | (2) | - | - | - | - | - | - | 105,000 | (2) | |||||||||||||||||||||||||
| President, Interim Chief Executive Officer | 2024 | 78,750 | (3) | - | - | - | - | - | - | 78,750 | (3) | |||||||||||||||||||||||||
| Charles Todd | 2025 | 210,000 | (4) | - | - | - | - | - | - | 210,000 | (4) | |||||||||||||||||||||||||
| Former Chief Executive Officer and Former Director | 2024 | (5) | - | - | - | - | - | - | - | |||||||||||||||||||||||||||
| Scott J. Silverman | 2025 | 105,000 | (6) | - | - | - | - | - | - | 105,000 | (6) | |||||||||||||||||||||||||
| Chief Financial Officer, Secretary and Treasurer | 2024 | 105,000 | (7) | - | - | - | - | - | - | 105,000 | (7) | |||||||||||||||||||||||||
| Marvin S. Hausman, M.D | 2025 | 105,000 | (8) | - | - | - | - | - | - | 105,000 | (8) | |||||||||||||||||||||||||
| Chief Science Officer, Former President, and Director, and Former CEO | 2024 | 105,000 | (9) | - | - | - | - | - | - | 105,000 | (9) | |||||||||||||||||||||||||
| (1) | Mr. Reyes served as our Chief Operating Officer from February 2023 until his appointment as our Chief Executive Officer in September 2024 until his resignation as CEO in April 21, 2025 and as our Interim Chief Executive Officer effective as of October 1, 2025. Between April 21, 2025 and October 1, 2025, Mr. Reyes served the Company in a non-executive role. |
| (2) | All $105,000 of this amount was accrued |
| (3) | $56,250 of this amount was accrued |
| (4) | $210,000 of this amount was accrued |
| (5) | Mr. Todd was not employed by the Company until January, 2025. |
| (6) | $41,250 of this amount was accrued. |
| (7) | $48,750 of this amount was accrued. |
| (8) | $75,000 of this amount was accrued. |
| (9) | All $105,000 of this amount was accrued. |
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Outstanding Option Awards
The following table provides certain information regarding unexercised options to purchase common stock, stock options that have not vested and equity-incentive plan awards outstanding as of the date of this Annual Report, for each named executive officer.
| Option Awards | Stock Awards | |||||||||||||||||||||||||||||||||||
| Name |
Number of Securities Underlying Unexercised Options (#) Exercisable |
Number of Securities Underlying Unexercised Options (#) Unex- ercisable |
Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options |
Option Exercise Price |
Option Expiration Date |
Number of Shares or Units of Stock That Have Not Vested |
Market Value of Shares or Units of Stock That Have Not Vested |
Equity Incentive Plan Awards: Number of Unearned Shares, Units or Other Rights That Have Not Vested |
Equity Incentive Plan Awards: Market or Payout Value of Unearned Shares, Units or Other Rights That Have Not Vested |
|||||||||||||||||||||||||||
| Jose Antonio Reyes | - | - | - | - | n/a | - | n/a | - | - | |||||||||||||||||||||||||||
| Scott J. Silverman | - | - | - | - | n/a | - | n/a | - | - | |||||||||||||||||||||||||||
| Marvin S. Hausman, M.D. | - | - | - | - | n/a | - | n/a | - | - | |||||||||||||||||||||||||||
Employment Agreements
Jose Antonio Reyes On April 1, 2024, Jose Antonio Reyes signed an Offer Letter for his employment as our Chief Operating Officer. In September 2024, Mr. Reyes was named as our Chief Executive Officer. In January, 2025, Mr. Reyes resigned as our Chief Executive Officer, but remained in a non-executive position. In October, 2025, Mr. Reyes was appointed our Interim Chief Executive Officer. Pursuant to the terms of his employment, which remained the same throughout his tenure, the Company is obliged to make monthly payments to Mr. Reyes of $8,750, as follows:
Beginning from the execution date of the Offer Letter and continuing until the Company raises $750,000 in equity or debt financing (the “Accrual Period”), the Company is obligated to make the monthly payments described in the following table:
| Funds Raised | Paid Monthly |
Accrued Monthly |
||||||
| $0 – $250,000 | $ | 3,750 | $ | 5,000 | ||||
| $250,000 – $750,000 | $ | 5,000 | $ | 3,750 | ||||
Upon the Company’s raising of $750,000, it shall pay the accrued amount in cash. Thereafter, the Company shall pay the entire monthly payment without accrual.
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Scott J. Silverman. On November 15, 2023, we entered into a Financial Advisory Services Agreement (the “CFO Agreement”) with Thornhill Advisory Group, Inc. (f/k/a EverAsia Financial Group, Inc.), a financial consulting firm owned by Scott J. Silverman, who, in conjunction with the execution the CFO Agreement, was appointed as our Chief Financial Officer. Pursuant to the terms of the CFO Agreement, Mr. Silverman shall serve as our Chief Financial Officer for an initial term of one (1) year, with automatic three-month extension terms thereafter, unless either party provides notice of its intent not to renew. In addition, the CFO Agreement may be terminated at any time by either party, upon 60-days’ notice.
Under the CFO Agreement, the Company is obligated to make monthly payments of $8,750, as follows:
Beginning from the execution date of the CFO Agreement and continuing until the Company raises $750,000 in equity or debt financing (the “Accrual Period”), the Company is obligated to make the monthly payments described in the following table:
| Funds Raised | Paid Monthly |
Accrued Monthly |
||||||
| $0 – $250,000 | $ | 3,750 | $ | 5,000 | ||||
| $250,000 – $750,000 | $ | 5,000 | $ | 3,750 | ||||
Upon the Company’s raising of $750,000, it shall pay the accrued amount in cash. Thereafter, the Company shall pay the entire monthly payment without accrual.
Marvin S. Hausman, M.D. On April 1, 2024, Marvin S. Hausman., M.D. signed an Offer Letter for his employment as our Chief Science Officer. Additionally, Dr. Hausman served as our Chairman of the Board of Directors until he resigned in April 2025. Pursuant to the terms of his employment, the Company is obliged to make monthly payments to Dr. Hausman of $8,750, as follows:
Beginning from the execution date of the Offer Letter and continuing until the Company raises $750,000 in equity or debt financing (the “Accrual Period”), the Company is obligated to make the monthly payments described in the following table:
| Funds Raised | Paid Monthly |
Accrued Monthly | ||||||
| $0 – $250,000 | $ | 3,750 | $ | 5,000 | ||||
| $250,000 – $750,000 | $ | 5,000 | $ | 3,750 | ||||
Upon the Company’s raising of $750,000, it shall pay the accrued amount in cash. Thereafter, the Company shall pay the entire monthly payment without accrual.
From September 5, 2023 until April 1, 2024, Marvin S. Hausman, M.D., served as our Chief Executive Officer. Under his employment agreement, we paid Dr. Hausman $5,000 per month. In addition, we were to pay Dr. Hausman an amount equal to 10% of gross sales revenues attributable to Dr. Hausman’s efforts, in perpetuity. The Agreement was terminated on April 1, 2024 when Dr. Hausman signed an offer for his employment as our Chief Science Officer.
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Outstanding Equity Awards
Our Board of Directors has made no equity awards and no such award is pending.
Equity Compensation Plan Information
Our Board has adopted the 2024 Stock Incentive Plan (the “Plan”).
The following table sets forth information about our equity compensation plans as of December 31, 2025.
| Number of securities to be issued upon exercise of outstanding options, warrants and rights (a) |
Weighted- average exercise price of outstanding options, warrants and rights (b) |
Number of securities remaining available for future issuance under the equity compensation plan (excluding securities reflected in column (a) (c) |
||||||||||
| Equity compensation plan approved by security holders | $ | 30,000,000 | ||||||||||
| Equity compensation plan not approved by security holders | — | — | — | |||||||||
| Total | $ | 30,000,000 | ||||||||||
Summary of the Plan
Authorized Shares
There are currently 30,000,000 shares of our Common Stock available for issuance pursuant to the Plan. Shares of Common Stock issued under our Plan may be authorized but unissued or reacquired shares of our Common Stock. If any Award granted under this Plan is canceled, terminates, expires, or lapses for any reason, Shares subject to such Award shall be again available for the grant of an Award under the Plan. Additionally, in the event of any merger, reorganization, consolidation, recapitalization, separation, liquidation, Stock dividend, split-up, Share combination, or other change in the corporate structure of the Company affecting the Shares, an adjustment shall be made in the number and class of Shares which may be delivered under the Plan, as may be determined to be appropriate and equitable by the Board of Directors, in its sole discretion, to prevent dilution or enlargement of rights.
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Administration
Our Board has the authority to administer our Plan and may issue either unrestricted or restricted stock grants. Subject to the terms of our Plan, the Board has the authority to determine the terms of awards, including recipients, the number of shares of Common Stock subject to each stock award, the fair market value of a share of our Common Stock, the vesting schedule applicable to the awards, together with any vesting acceleration, and the terms and conditions of the award agreements for use under the Plan. The Committee has the power to modify outstanding awards under the Plan, subject to the terms of the Plan and applicable law.
Restricted Stock
The terms and conditions of any restricted stock awards granted to a participant will be set forth in an award agreement and, subject to the provisions in the Plan, will be determined by the Committee. Under a restricted stock award, we issue shares of our Common Stock to the recipient of the award, subject to vesting conditions and transfer restrictions that lapse over time or upon achievement of performance conditions. The Committee will determine the vesting schedule and performance objectives, if any, applicable to each restricted stock award. Unless the Committee determines otherwise, the recipient may vote and receive dividends on shares of restricted stock issued under our Plan.
Merger, Consolidation or Asset Sale
If the Company is merged or consolidated with another entity or sells or otherwise disposes of substantially all of its assets to another company while awards or options remain outstanding under the Plan, unless provisions are made in connection with such transaction for the continuance of the Plan and/or the assumption or substitution of such awards or options with new options or stock awards covering the stock of the successor company, or parent or subsidiary thereof, with appropriate adjustments as to the number and kind of shares and prices, then all outstanding options and stock awards which have not been continued, assumed or for which a substituted award has not been granted shall, whether or not vested or then exercisable, unless otherwise specified in the relevant agreements, terminate immediately as of the effective date of any such merger, consolidation or sale.
Change in Capitalization
If the Company shall effect a subdivision or consolidation of shares of Common Stock or other capital readjustment, the payment of a stock dividend, or other increase or reduction of the number of shares of Common Stock outstanding, without receiving consideration therefore in money, services or property, then awards amounts, type, limitations, and other relevant consideration shall be appropriately and proportionately adjusted. The Committee shall make such adjustments, and its determinations shall be final, binding and conclusive.
Plan Termination
No Awards may be issued under the Plan after December 31, 2029.
Director Compensation
We have made no payments to our directors in consideration of their services to date, and there is currently no agreement or arrangement to pay any of our directors for their service as directors in the future.
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Compensation Recovery and Clawback Policy
Under the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), in the event of misconduct that results in a financial restatement that would have reduced a previously paid incentive amount, we can recoup those improper payments from our Chief Executive Officer, Chief Financial Officer, and Chief Science Officer (if any). The SEC also recently adopted rules which direct national stock exchanges to require listed companies to implement policies intended to recoup bonuses paid to executives if the company is found to have misstated its financial results.
Additionally, on December 31, 2024, the Board of Directors of the Company adopted a Policy for the Recovery of Erroneously Awarded Incentive-Based Compensation (the “Clawback Policy”), to comply with the final clawback rules adopted by the U.S. Securities and Exchange Commission under Section 10D and Rule 10D-1 of the Securities Exchange Act of 1934, as amended (“Rule 10D-1”). The Clawback Policy provides for the mandatory recovery of erroneously awarded incentive compensation from current and former officers of the Company as defined in Rule 10D-1 (“Covered Officers”) in the event the Company is required to prepare an accounting restatement as specified in the Clawback Policy. Under the Clawback Policy, the Board may recoup from the Covered Officers erroneously awarded incentive compensation received within a lookback period of the three completed fiscal years preceding the date on which the Company is required to prepare an accounting restatement. The Clawback Policy is effective as of December 31, 2024.
Company Policies and Practices Related to the Grant of Certain Equity Awards Close in Time to the Release of Material Nonpublic Information
We do not have a policy on the timing of awards of options in relation to the disclosure by us of material nonpublic information. During the fiscal year ended December 31, 2025, no Named Executive Officer was awarded stock options, and we did not time the disclosure of material nonpublic information for the purpose of affecting the value of executive compensation.
Director Compensation
As of the filing date, no compensation has been provided to our directors.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The following table sets forth information about the beneficial ownership of our capital stock at March 6, 2026, for:
| ● | each person known to us to be the beneficial owner of more than 5% of our common stock; | |
| ● | each named executive officer; | |
| ● | each of our directors; and | |
| ● | all of our named executive officers and directors as a group. |
Unless otherwise indicated, the business address of each person listed is c/o Ludwig Enterprises, Inc., 8950 SW 74th Ct, Ste 2201-A149, Miami, FL 33156. The percentages in the table have been calculated on the basis of treating as outstanding for a particular person, all shares of our common stock outstanding on that date and all shares of our common stock issuable to that holder in the event of exercise of outstanding options, warrants, rights or conversion privileges owned by that person at that date which are exercisable within 60 days of that date. Except as otherwise indicated, the persons listed below have sole voting and investment power with respect to all shares of our common stock owned by them, except to the extent that power may be shared with a spouse.
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In computing the number of shares of our common stock beneficially owned by a person and the percentage ownership of that person, we deemed outstanding shares of our common stock subject to options, warrants, preferred stock or restricted stock units held by that person that are currently exercisable or convertible or exercisable or convertible within 60 days of March 16, 2026. We did not deem these shares outstanding, however, for the purpose of computing the percentage ownership of any other person.
| Number of Shares | % | |||||||||
| Beneficially | Beneficially | Effective Voting | ||||||||
| Name of Shareholder | Owned | Owned(1) | Power | |||||||
| Common Stock | ||||||||||
| Named Executive Officers and Directors | ||||||||||
| Jose Antonio Reyes | 0 | 0 | % | |||||||
| Scott J. Silverman | 0 | 0 | % | |||||||
| Marvin S. Hausman, M.D. | 243,800,000 | (2) | 28.26 | % | See Note 10 | |||||
| Garth Lees-Rolfe | 0 | 0 | % | |||||||
| Corain McGinn | 0 | 0 | % | |||||||
| Officers and directors, as a group (3 persons) | 243,800,000 | (2) | 31.69 | % | ||||||
| 5% Owners | ||||||||||
| Thomas Terwilliger | 303,082,053 | (3) | 35.14 | % | ||||||
| Baranquilla Investments, LLC (4) | 200,000,000 | (5) | 23.19 | % | ||||||
| Vasaio Capital, Inc.(6) | 200,000,000 | (7) | 23.191 | % | ||||||
| Convertible Preferred Stock (8) | ||||||||||
| Barranquilla Investments, LLC (4) | 2,000,000 | 28.57 | % | |||||||
| Thomas Terwilliger | 3,000,000 | 42.86 | % | |||||||
| Vasaio Capital, Inc. (6) | 2,000,000 | 28.57 | % | |||||||
| * | Less than 1%. |
| (1) | Based on 862,569,807 shares , which includes (a) 162,569,807 issued and outstanding shares, and (b) 700,000,000 unissued shares that underlie shares of Convertible Preferred Stock.. |
| (2) | 200,000,000 of these shares are unissued but underlie currently convertible shares of our Convertible Preferred Stock. |
| (3) | 1,175,992 of these shares are owned by Tadas Trust, James Williams, Trustee, the beneficiary of which is Mr. Terwilliger; and 102,710 of these shares are owned by Barr Irrevocable Trust, the trustee of which trust is Mr. Terwilliger. |
| (4) | The manager of Barranquilla Investments, LLC is Marvin S. Hausman, M.D., our Chief Science Officer. Dr. Hausman has the sole voting and dispositive control over the shares held by Barranquilla Investments, LLC. The address of this shareholder is 1309 Coffeen Avenue, Suite 1200, Sheridan, Wyoming 82801. |
| (5) | These shares are unissued but underlie currently convertible shares of our Convertible Preferred Stock owned by Barranquilla Investments, LLC. |
| (6) | Frank Magliochetti is the Chief Executive Officer of Vasaio Capital, Inc. Mr. Magliochetti has the sole voting and dispositive control over the shares held by Vasaio Capital, Inc. The address of this shareholder is 288 Grove Streeet, Suite 361, Braintree, Massachusetts 02184. |
| (7) | These shares are unissued, but underlie currently convertible shares of our Convertible Preferred Stock owned by Vasaio Capital, Inc. |
| (8) | Each share of Convertible Preferred Stock (a) is convertible into 100 shares of our common stock at any time and (b) has the following voting rights: each share of Convertible Preferred Stock shall vote on all matters as a class with the holders of common stock and each share of Convertible Preferred Stock shall be entitled to the number of votes equal to the “conversion rate,” or 100 votes per share. |
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Equity Compensation Plan Information
Our Board has adopted the 2024 Stock Incentive Plan (the “Plan”).
The following table sets forth information about our equity compensation plans as of December 31, 2025.
| Number of securities to be issued upon exercise of outstanding options, warrants and rights (a) |
Weighted- average exercise price of outstanding options, warrants and rights (b) |
Number of securities remaining available for future issuance under the equity compensation plan (excluding securities reflected in column (a) (c) |
||||||||||
| Equity compensation plan approved by security holders | $ | 30,000,000 | ||||||||||
| Equity compensation plan not approved by security holders | - | - | - | |||||||||
| Total | $ | 30,000,000 | ||||||||||
Summary of the Plan
Authorized Shares
There are currently 30,000,000 shares of our Common Stock available for issuance pursuant to the Plan. Shares of Common Stock issued under our Plan may be authorized but unissued or reacquired shares of our Common Stock. If any Award granted under this Plan is canceled, terminates, expires, or lapses for any reason, Shares subject to such Award shall be again available for the grant of an Award under the Plan. Additionally, in the event of any merger, reorganization, consolidation, recapitalization, separation, liquidation, Stock dividend, split-up, Share combination, or other change in the corporate structure of the Company affecting the Shares, an adjustment shall be made in the number and class of Shares which may be delivered under the Plan, as may be determined to be appropriate and equitable by the Board of Directors, in its sole discretion, to prevent dilution or enlargement of rights.
Administration
Our Board has the authority to administer our Plan and may issue either unrestricted or restricted stock grants. Subject to the terms of our Plan, the Board has the authority to determine the terms of awards, including recipients, the number of shares of Common Stock subject to each stock award, the fair market value of a share of our Common Stock, the vesting schedule applicable to the awards, together with any vesting acceleration, and the terms and conditions of the award agreements for use under the Plan. The Committee has the power to modify outstanding awards under the Plan, subject to the terms of the Plan and applicable law.
Restricted Stock
The terms and conditions of any restricted stock awards granted to a participant will be set forth in an award agreement and, subject to the provisions in the Plan, will be determined by the Committee. Under a restricted stock award, we issue shares of our Common Stock to the recipient of the award, subject to vesting conditions and transfer restrictions that lapse over time or upon achievement of performance conditions. The Committee will determine the vesting schedule and performance objectives, if any, applicable to each restricted stock award. Unless the Committee determines otherwise, the recipient may vote and receive dividends on shares of restricted stock issued under our Plan.
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Merger, Consolidation or Asset Sale
If the Company is merged or consolidated with another entity or sells or otherwise disposes of substantially all of its assets to another company while awards or options remain outstanding under the Plan, unless provisions are made in connection with such transaction for the continuance of the Plan and/or the assumption or substitution of such awards or options with new options or stock awards covering the stock of the successor company, or parent or subsidiary thereof, with appropriate adjustments as to the number and kind of shares and prices, then all outstanding options and stock awards which have not been continued, assumed or for which a substituted award has not been granted shall, whether or not vested or then exercisable, unless otherwise specified in the relevant agreements, terminate immediately as of the effective date of any such merger, consolidation or sale.
Change in Capitalization
If the Company shall effect a subdivision or consolidation of shares of Common Stock or other capital readjustment, the payment of a stock dividend, or other increase or reduction of the number of shares of Common Stock outstanding, without receiving consideration therefore in money, services or property, then awards amounts, type, limitations, and other relevant consideration shall be appropriately and proportionately adjusted. The Committee shall make such adjustments, and its determinations shall be final, binding and conclusive.
Plan Termination
No Awards may be issued under the Plan after December 31, 2029.
Item 13. Certain Relationships and Related Transactions, and Director Independence
Except as disclosed herein, no director, executive officer, shareholder holding at least 5% of shares of our Common Stock, or any family member thereof, had any material interest, direct or indirect, in any transaction, or proposed transaction since January 1, 2024, in which the amount involved in the transaction exceeds the lesser of $120,000 or one percent of the average of our total assets at the year-end for the last two completed fiscal years.
Simple Promissory Note
In November, 2025, the Company issued Promissory Notes to Thornhill Advisory Group (“Thornhill”), a company beneficially owned by our Chief Financial Officer, in the principal amount of $9,018 bearing the interest rate of 1% per annum, with principal and interest repayable in full on or before January 30, 2026. The Note was repaid in February 2026.
In December, 2025, the Company issued Promissory Notes to Thornhill for $8,865 bearing the interest rate of 8% per annum, with principal and interest repayable in full on or before January 30, 2026.. The Note was repaid in February 2026.
On March 10, 2025, we issued a simple promissory note to our former Chief Executive Officer, Charles Todd, Jr., in the principal amount of $36,912. This promissory note bears an interest rate of eight (8%) per annum, and is not convertible. The principal and accrued interest of the note is due on September 30, 2025, in the event that the we fail to repay this promissory note on September 30, 2025, the note will become immediately due and payable and Mr. Todd will have the right to renegotiate the terms of this promissory note. On March 12, 2026, Mr. Todd agreed to extend the Promissory Note until May 31, 2026.
On December 17, 2024, we issued a simple promissory note to our Interim Chief Executive Officer Jose Antonio Reyes in the principal amount of $5,000. This promissory note bore interest at the rate of eight (8%) per annum, and was not convertible. The maturity date of the principal and accrued interest of the note was March 31, 2025, in the event that the we failed to repay this promissory note on March 31, 2025, the note became immediately due and payable and Mr. Reyes had the right to renegotiate the terms of this promissory note. In May 2025, the Company redeemed the promissory note in the principal amount of $5,000 and accrued interest of $165.
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Common Stock Repurchase Agreement
Effective August 10, 2023, we entered into a Common Stock Repurchase Agreement (the “Repurchase Agreement”) with Worthington Financial Services, Inc. (“Worthington”), pursuant to which we repurchased 171,162,746 shares of our Common Stock (the “Worthington Shares”). In payment of such shares, we issued a promissory note (the “Worthington Note”) in the principal amount of $122,873 that bears interest at 8% per annum. The Worthington Note was originally due on the earlier to occur of (1) our receipt of the first $500,000 in proceeds in an Offering (of which there is no assurance) and (2) August 31, 2024. Under the Worthington Note, an event of default occurs if (1) we fail on the maturity date to pay timely the principal and accrued interest or (2) fail to timely file with OTC Markets or any regulatory agency, including the SEC, a required filing or (3) fail to timely pay, in full, any creditor or note holder of our Company. Upon any such event of default, the then-unpaid principal amount shall bear interest at 18% per annum. In addition to customary rights of a creditor, upon an event of default under the Worthington Note, Worthington shall have the right, in its sole discretion, to rescind the Repurchase Agreement and to have the Worthington Shares reissued to it. The Note has been extended until March 31, 2026.
Intellectual Property Conveyance
On September 16, 2024, we entered into the IP Agreement, with our Chief Science Officer, Marvin S. Hausman, M.D., and Nova. The basis for the IP Agreement is that certain mRNA Neuro Panel and Serotonin Assay, lodged by Nova on or about April 26, 2024, as U.S. Patent Application 18/705375, International Publication Number WO 2023/077245, captioned as “Diagnosing, Monitoring and Treating Neurological Disease with Psychoactive Tryptamine Derivatives and mRNA Measurements” (the “Patent”), the invention of which was done by Hausman in collaboration with Nova Mentis Life Science Corp.
The stated purpose of the IP Agreement was to resolve all obligations owed to Hausman by Nova, including but not limited to $245,712.00 in unpaid consulting consideration (the “Consulting Consideration”), by and through conveyance of all right, title and interest Nova may have held in the Patent and associated intellectual property associated therewith to the Company (the “Conveyance”) for further commercialization (the “Commercialization”).
In addition to the Patent, the Conveyance related to the following: (1) those serotonin assay(s) being developed by Dr. Kiminobu Sugaya at the University of Central Florida, including, but not limited to, preclinical and clinical data deriving therefrom or associated therewith; (2) exosome development protocol currently active at the laboratory of Dr. Kiminobu Sugaya at the University of Central Florida, including blood samples sent from the laboratory of Dr. Viviana Trezza and analysis data thereof obtained by Fabrizio Ascone; (3) work product and output of the Autism Spectrum Disorder (ASD) and Fragile X Syndrome (FSX) Patient Observational Study commissioned by Nova and conducted by Dr. Sugaya; and (4) work product and output of the Ambert/Molinaro Evaluation of 30 to 40 ASD patient mRNA cheek swab samples sent to genetic lab of Irina Borodowsky and analyzed by Dr. Kyle Ambert PhD as to genetic biomarkers and indices in the ASD questionnaire developed by John Molinaro.
In consideration for the Conveyance, the Company, Hausman and Nova agreed to the following reciprocal terms:
| (a) | As to Hausman: Hausman shall accept the Conveyance, directed by Hausman to the Company for future potential Commercialization, as a full and non-recourse waiver, release and satisfaction of any obligations now owed or owing to him by Nova, including, but not limited to, payment of the Consulting Consideration. Other than as to a breach of the IP Agreement, Hausman expressly waived and released Nova from any and all claims, known or unknown, he might assert against it, which waiver and release is willful, knowing, intelligent, and voluntary. |
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| (b) | As to the Company: As consideration for its receipt of the Patent from Nova, as directed thereto by Hausman, the Company agreed to: |
| a. | for a term of 10 years beginning on September 16, 2024, (the “Royalty Term”), allocate a royalty (the “Nova Royalty”) comprised of 5% of all revenue derived from the Commercialization, to be paid in equal amounts of 2.5% each to Nova and Hausman, until such time as Hausman shall have received an amount equal to the Consulting Consideration, whereupon Nova shall, thereafter, receive the full 5% for the balance of the Royalty Term; and |
| b. | issue to Nova 750,000 shares of Company common stock (the “Consideration Shares”), which Consideration Shares shall immediately vest upon the execution of the IP Agreement, though subject to the following “lock-up” restrictions, to wit: |
| i. | the Consideration Shares shall be subject to a one-year “lock-up,” during which the Consideration Shares may not be sold; |
| ii. | at the expiration of such one-year “lock-up,” Nova may sell up to 500 Consideration Shares during the next six-month period; and |
| iii. | at the expiration of such six-month period, Nova may sell up to 100,000 Consideration Shares per quarter. |
| c. | As to Nova: In consideration for the mutual promises and benefits in favor of Nova under the IP Agreement, Nova shall effect the Conveyance and shall be entitled to no further payment or consideration, other than as expressly set forth herein. Other than as to a breach of the IP Agreement, Nova expressly waived and released Hausman from any and all claims, known or unknown, it might assert against him, which waiver and release is willful, knowing, intelligent, and voluntary. |
Commercial Registered Agent
We pay Corporate World, Inc. $350 annually for its registered agent services, which include mail-forwarding and similar administrative services.
Item 14. Principal Accountant Fees and Services
The following table sets forth fees billed to us by our independent auditors during the fiscal years ended December 31, 2025 and 2024, for: (a) services rendered for the audit of our annual financial statements and the review of our quarterly financial statements, (b) services by our auditors that are reasonably related to the performance of the audit or review of our financial statements and that are not reported as Audit Fees, (c) services rendered in connection with tax compliance, tax advice and tax planning and (d) all other fees for services rendered.
| Year Ended December 31, 2025 |
Year Ended December 31, 2024 |
|||||||
| Audit Fees | $ | 54,600 | $ | 56,500 | ||||
| Audit Related | $ | 4,500 | $ | 4,500 | ||||
| Fees | $ | 0 | $ | 0 | ||||
| Tax | $ | 0 | $ | 0 | ||||
| All Other Fees | $ | 0 | $ | 0 | ||||
| Total | $ | 59,100 | $ | 61,000 | ||||
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PART IV
Item 15. Exhibits and Financial Statement Schedules
The following documents are filed as part of this Annual Report on Form 10-K:
| (1) | Financial Statements (included in Item 8): |
Ludwig Enterprises, Inc. - Audited Consolidated Financial Statements for the Years Ended December 31, 2025 and 2024
| (2) | Financial Statement Schedules: None |
| (3) | Exhibits: |
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| 10.15 | Executive Employment Agreement Between Registrant and Marvin S. Hausman, M.D. | S-1/A | 333-271439 | 10.16 | Filed previously | |||||
| 10.16 | Form of Securities Purchase Agreement entered into between March 28, 2024 and January 10, 2025 | S-1 | 333-284885 | 10.16 | Filed previously | |||||
| 10.17 | Termination Agreement between Registrant and Marvin S. Hausman | S-1/A | 333-271439 | 10.13 | Filed previously | |||||
| 10.18 | Termination Agreement between Registrant and Homeopathic Partners, Inc. | S-1/A | 333-271439 | 10.14 | Filed previously | |||||
| 10.19 | Consulting Agreement dated July 1, 2022 between Registrant and Homeopathic Partners, Inc. | S-1/A | 333-271439 | 10.4 | Filed previously | |||||
| 10.20 | Consulting Agreement dated July 1, 2022, between Registrant and Marvin S. Hausman, M.D. | S-1/A | 333-271439 | 10.5 | Filed previously | |||||
| 10.21 | Employment Agreement with Chief Executive Officer dated April 21, 2025 | 8-K | 25859313 | 10.1 | Filed previously | |||||
| 10.22 | Securities Purchase Agreement, dated February 5, 2026, by and between the Company and Alumni Capital LP | 8-K | 26619306 | 10.1 | Filed previously | |||||
| 10.23 | Capital Markets Advisory Agreement with Exchange Listing dated April 26, 2024 | S-1/A | 333-284885 | 10.23 | Filed previously | |||||
| 10.24 | 2026 Equity Incentive Plan | S-1/A | 333-284885 | 10.24 | Filed previously | |||||
| 14.1 | Code of Business Conduct and Ethics | 10-K | 25788508 | 14.1 | Filed previously | |||||
| 19.1 | Insider Trading Policy | 10-K | 25788508 | 19.1 | Filed previously | |||||
| 21.1 | Subsidiaries of Registrant | S-1/A | 333-271439 | 22.1 | Filed previously | |||||
| 23.1 | Consent of Assurance Dimensions, Inc., Independent Registered Public Accounting Firm | Filed herewith | ||||||||
| 31.1 | CEO Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | Filed herewith | ||||||||
| 31.2 | CFO Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | Filed herewith | ||||||||
| 32.1 | Certification pursuant to 18 U.S.C. Section 1350 | Filed herewith | ||||||||
| 101.INS | Inline XBRL Instance Document. | Filed herewith | ||||||||
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document. | Filed herewith | ||||||||
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document. | Filed herewith | ||||||||
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document. | Filed herewith | ||||||||
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document. | Filed herewith | ||||||||
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | Filed herewith | ||||||||
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). | Filed herewith |
| * | Filed herewith. |
Item 16. Form 10-K Summary
None.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| LUDWIG ENTERPRISES, INC. | ||
| Dated: March 16, 2026. | By: | /s/ Jose Antonio Reyes |
| Jose Antonio Reyes | ||
| Interim Chief Executive Officer | ||
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 dates indicated.
| Name | Title(s) | Date | ||
| /s/ Jose Antonio Reyes | Interim Chief Executive Officer | March 16, 2026 | ||
| Jose Antonio Reyes | [Principal Executive Officer] | |||
| /s/ Scott J. Silverman | Chief Financial Officer | March 16, 2026 | ||
| Scott J. Silverman | [Principal Financial Officer and Principal Accounting Officer] and Director | |||
| /s/ Garth Lees-Rolfe | Director | March 16, 2026 | ||
| Garth Lees-Rolfe | ||||
| /s/ Corain McGinn | Director | March 16, 2026 | ||
| Corain McGinn |
78
INDEX TO FINANCIAL STATEMENTS
Ludwig Enterprises, Inc.
| Audited Financial Statements for the Years Ended December 31, 2025 and 2024 |
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders’
of Ludwig Enterprises Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheet of Ludwig Enterprises, Inc. (the Company) as of December 31, 2025, and the related statements of operations, changes in stockholders’ deficit and cash flows for the year ended December 31, 2025, 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, 2025 and the results of its operations and its cash flows for the year ended December 31, 2025, 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 financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has experienced a net loss and negative cash flows from operations for theyear ended December 31, 2025, which raises substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. 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 audit. 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 audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit 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 audit, 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 audit 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 audit 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 audit provide a reasonable basis for our opinion.
/s/
We have served as the Company’s auditor since 2025.
March 16, 2026
F-2
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders’
of Ludwig Enterprises Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Ludwig Enterprises, Inc. and Subsidiaries (the Company) as of December 31, 2024 and 2023, and the related statements of operations, changes in stockholders’ deficit and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the financial statements). In our opinion, the consolidated 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.
Explanatory Paragraph- Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 of the consolidated financial statements, the Company suffered recurring losses from operations and has a significant accumulated deficit of $7,259,366 at December 31, 2024. For the year ended December 31, 2024, the Company incurred net loss of $3,016,884 and net cash used in operations of $660,302. In addition, the Company continues to experience negative cash flows from operations. The Company’s ability to continue as a going concern is dependent on its ability to raise debt or equity-based capital at favorable terms. These factors raise substantial doubt about the Company’s ability to continue as a going concern. This gives rise to substantial doubt about the Company’s ability to continue as a going concern for a period of twelve months after the issuance of these financial statements. Management’s plans in regard to these matters are also described in Note 1. The consolidated 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 consolidated financial statements based on our audit. 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 audit 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.
ASSURANCE DIMENSIONS, LLC
also d/b/a McNAMARA and ASSOCIATES, LLC
TAMPA BAY: 4920 W Cypress Street, Suite 102 | Tampa, FL 33607 | Office: 813.443.5048 | Fax: 813.443.5053
JACKSONVILLE: 7800 Belfort Parkway, Suite 290 | Jacksonville, FL 32256 | Office: 888.410.2323 | Fax: 813.443.5053
ORLANDO: 1800 Pembrook Drive, Suite 300 | Orlando, FL 32810 | Office: 888.410.2323 | Fax: 813.443.5053
SOUTH FLORIDA: 3111 N. University Drive, Suite 621 | Coral Springs, FL 33065 | Office: 754.800.3400 | Fax: 813.443.5053
www.assurancedimensions.com
F-3
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.
Valuation of the consideration received from the sale of Exousia Ai, Inc. (“EXO”)
Description of the matter and considerations leading to the matter
As described in Note 3, on December 31, 2024, the Company entered into a Stock Purchase Agreement (the “Exousia SPA”) with Marijuana, Inc., a publicly-traded Florida corporation (symbol: MAJI) (“Purchaser”), pursuant to which Purchaser would purchase 100% ownership of a subsidiary of the Company, Exousia Ai, Inc. The purchase price under the Exousia SPA for 100% ownership of EXO is approximately $203,000, payable by Purchaser by delivery of (a) 103,000 of assumed liabilities (b) 10,000 shares of Purchaser Series B Convertible Preferred stock (the “Purchaser Shares”) and (c) a $100,000 principal amount promissory note (the “Purchaser Note”). Series B Convertible Preferred stock is convertible into 4,700 Purchaser common stock. The Purchaser Note bears interest at eight percent (8%) per annum, with principal and accrued interest due December 31, 2025. The valuation of the purchase price, specifically the preferred stock, was complex due to the fact that MAJI is not an operating Company and did not have a fair market value assessment for its stock.
Description of how the matter was addressed
We obtained management’s assessment, analysis and memo to support the rationale and method used by the Company for valuation of the purchase price which was based on cost of the main asset purchased by MAJI in the absence of supported and reasonable fair market value approaches. We detailed tested the costs and obtained invoice support to ensure the costs were accurate. We verified through guidance that the accounting treatment was appropriate including conversations with our technical experts on the matter.
Conclusion
Based on management’s assessment and our audit procedures we concluded that the fair value of the preferred stock and total purchase price recorded was reasonable.
| We have served as the Company’s auditor since 2022. | |
| Coral Springs, Florida | |
| March 28, 2025 | |
F-4
Ludwig Enterprises, Inc.
Balance Sheets
| December 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current Assets | ||||||||
| Cash | $ | $ | ||||||
| Inventory | ||||||||
| Prepaid expenses | ||||||||
| Deferred offering cost | ||||||||
| Note receivable | ||||||||
| Total Current Assets | ||||||||
| Intangible assets, net of accumulated | ||||||||
| Total Assets | $ | $ | ||||||
| Liabilities and Stockholders’ Deficit | ||||||||
| Current Liabilities | ||||||||
| Bank overdraft | $ | $ | ||||||
| Accounts payable and accrued expenses | ||||||||
| Accounts payable and accrued expenses – related party | ||||||||
| Notes payable | ||||||||
| Convertible notes payable, net | ||||||||
| Notes payable - related party | ||||||||
| Derivative liability | ||||||||
| Total Current Liabilities | ||||||||
| Total Liabilities | ||||||||
| Stockholders’ Deficit | ||||||||
| Preferred stock: |
||||||||
| Common stock: |
||||||||
| Additional paid in capital | ||||||||
| Accumulated deficit | ( |
) | ( |
) | ||||
| Total Stockholders’ Deficit | ( |
) | ( |
) | ||||
| Total Liabilities and Stockholders’ Deficit | $ | $ | ||||||
The accompanying notes are an integral part of these financial statements.
F-5
Ludwig Enterprises, Inc.
Statements of Operations
| Years Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenues | $ | $ | ||||||
| Operating expenses | ||||||||
| General and administration expenses | ||||||||
| Research and development | ||||||||
| Total operating expenses | ||||||||
| Net loss from operations | ( | ) | ( | ) | ||||
| Other income (expense) | ||||||||
| Interest income | ||||||||
| Other income | ||||||||
| Inducement expense | ( | ) | ||||||
| Finance expense | ( | ) | ||||||
| Interest expense | ( | ) | ( | ) | ||||
| Loss on debt extinguishment | ( | ) | ||||||
| Gain on Change in fair value of derivative liability | ||||||||
| Amortization of debt discount | ( | ) | ( | ) | ||||
| Total other expense | ( | ) | ( | ) | ||||
| Net loss before taxes | ( | ) | ( | ) | ||||
| Income tax benefit | ||||||||
| Loss from continuing operations | $ | ( | ) | $ | ( | ) | ||
| Income from discontinued operation, net of tax | $ | $ | ||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Basic and diluted loss per common share from continuing operations | $ | ( | ) | $ | ( | ) | ||
| Basic and diluted income per common share from discontinued operations | $ | $ | ||||||
| Basic and diluted loss per common share | $ | ( | ) | $ | ( | ) | ||
| Basic and diluted weighted average common shares outstanding | ||||||||
The accompanying notes are an integral part of these financial statements.
F-6
Ludwig Enterprises, Inc.
Statements of Changes in Stockholders’ Deficit
For the years ended December 31, 2025 and 2024
| Convertible | Additional | |||||||||||||||||||||||||||
| Preferred Stock | Common Stock | Paid in | Accumulated | |||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Total | ||||||||||||||||||||||
| Balance, December 31, 2023 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
| Common stock issued for services | - | |||||||||||||||||||||||||||
| Common stock issued for R&D expenses | - | |||||||||||||||||||||||||||
| Common stock issued for inducement expense | - | |||||||||||||||||||||||||||
| Warrants issued for commitment fee | - | - | ||||||||||||||||||||||||||
| Warrants issued for inducement expense and debt discount | - | - | ||||||||||||||||||||||||||
| Cancellation of common stock | - | ( | ) | |||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
| Balance, December 31, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
| Common stock issued for services | - | |||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
| Balance, December 31, 2025 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
The accompanying notes are an integral part of these financial statements.
F-7
Ludwig Enterprises, Inc.
Statements of Cash Flows
| Years Ended December 31, | ||||||||
| 2025 | 2024 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock issued for services | ||||||||
| Stock issued for research and development | ||||||||
| Stocks issued for inducements | ||||||||
| Stock warrants issued for finance cost | ||||||||
| Gain on sale of subsidiary | ( | ) | ||||||
| Amortization of debt discount | ||||||||
| Loss on extinguishment of debt | ||||||||
| Change in fair value of derivative liability | ( | ) | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Inventory | ( | ) | ( | ) | ||||
| Note Receivable | ( | ) | ||||||
| Prepaid expenses | ( | ) | ||||||
| Unearned fee | ( | ) | ||||||
| Accounts payable and accrued liabilities | ||||||||
| Accounts payable and accrued liabilities – related party | ||||||||
| Net Cash Used in Operating Activities | ( | ) | ( | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Purchase of intellectual property | ( | ) | ||||||
| Net Cash Used in Investing Activities | ( | ) | ||||||
| Cash Flows from Financing Activities: | ||||||||
| Deferred offering cost | ( | ) | ( | ) | ||||
| Proceeds from related party | ||||||||
| Repayments to related party | ( | ) | ||||||
| Proceeds from convertible notes payable - net | ||||||||
| Repayment of convertible note and guaranteed interest | ( | ) | ||||||
| Repayment of note payable | ( | ) | ||||||
| Cash advance from investor | ||||||||
| Increase in bank overdraft | ||||||||
| Net Cash Provided by Financing Activities | ||||||||
| Net change in cash | ( | ) | ( | ) | ||||
| Cash, beginning of year | ||||||||
| Cash, end of year | $ | $ | ||||||
| Supplemental cash flow information: | ||||||||
| Cash paid for interest | $ | $ | ||||||
| Supplemental disclosure of non-cash financing activity | ||||||||
| Original issuance debt and guaranteed interest as debt discount | $ | $ | ||||||
| Derivative liability recognized as debt discount | $ | $ | ||||||
| Note receivable acquired in exchange with sale of subsidiary | $ | $ | ||||||
| Derivative liability recognized in connection with extinguishment of debt | $ | $ | ||||||
The accompanying notes are an integral part of these financial statements.
F-8
LUDWIG ENTERPRISES, INC.
NOTES TO FINANCIAL STATEMENTS
For the Years Ended December 31, 2025 and 2024
Note 1 – Organization and Nature of Operations
Organization and Nature of Operations
Ludwig Enterprises, Inc. (“the Company”), a Nevada Corporation (incorporated February 2006).
The Company is currently seeking to develop products and services through the use of cutting-edge technologies in the health care industry.
Formation of Subsidiaries
On May 18, 2022, the Company formed mRNA for Life, Inc. (“mRNA”), a Wyoming corporation, which is a wholly-owned subsidiary of the Company. mRNA is expected to produce supplements to address clinical diagnoses from mRNA cheek swabs.
On November 18, 2022, the Company formed Precision Genomics, Inc. (“PGI”), a Wyoming corporation, which is a wholly-owned subsidiary of the Company. PGI will be developing proprietary medical artificial intelligence (“AI”) technology that uses mRNA inflammatory language to potentially capture an inflammatory snapshot of disease and the body’s response to treatment.
On June 6, 2023, the Company formed Exousia Ai, Inc. (“EXO”), a Wyoming corporation, which is a wholly-owned subsidiary of the Company. EXO was formed to focus on studying the expression of differentially expressed mRNA genes in various chronic inflammatory diseases.
In October 2024, the Company dissolved
On December 31, 2024, the Company entered
into a Stock Purchase Agreement with Marijuana, Inc., a publicly-traded Florida corporation (“Purchaser”), pursuant to which
Purchaser would purchase
As of December 31, 2024, the Company disposed of or dissolved all of its subsidiaries. Accordingly, the financial statements for the year ended December 31, 2025 reflect only the parent company. The comparative financial statements for the year ended December 31, 2024 include the accounts of the Company and its subsidiaries, which were consolidated during that period.
Liquidity, Going Concern and Management’s Plans
These financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business.
As reflected in the accompanying financial statements, for the year ended December 31, 2025, the Company had:
| ● | Net loss of $ | |
| ● | Net cash used in operations was $ |
Additionally, at December 31, 2025, the Company had:
| ● | Accumulated deficit of $ | |
| ● | Stockholders’ deficit of $ | |
| ● | Working capital deficit of $ |
As of December 31, 2025, the Company has cash
deficit of $
The Company does not expect to generate sufficient revenues and positive cash flows from operations to meet its current obligations as they become due within the Evaluation Period. However, the Company will need to obtain and is exploring additional sources of financing including potential sources of debt or equity-based capital and/or strategic transactions at favorable terms, though such terms are not certain.
As a result of these conditions and uncertainties, management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern within one year after the date these consolidated financial statements are issued, and management’s plans do not alleviate that substantial doubt.
F-9
These factors create substantial doubt about the Company’s ability to continue as a going concern within the twelve-month period subsequent to the date that these financial statements are issued.
The consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern. Accordingly, the financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.
Management’s strategic plans include the following:
| ● | Raising funds to execute business operations more fully during the year ending December 31, 2026, |
| ● | Seek out strategic acquisitions of health care technology; and | |
| ● | Explore prospective partnership opportunities |
Note 2 – Summary of Significant Accounting Policies
Basis of Presentation
The accompanying consolidated financial statements for the years ended December 31, 2025 and 2024, have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”) and Generally Accepted Accounting Principles in the United States (“U.S. GAAP”) for financial information, which prescribes elimination of all significant inter-company accounts and transactions in the accounts of the Company and its wholly owned subsidiaries, mRNA for Life, Inc. which was incorporated in May, 2022, and Precision Genomics, Inc., which was incorporated in November , 2022 and were both dissolved in October 2024 and Exousia AI, Inc, which was incorporated in June 2023 and was sold in December 2024. In the opinion of management, these consolidated financial statements reflect all adjustments which are necessary for a fair statement of the Company’s financial position and results of its operations, as of and for the periods presented. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards
Reclassification
Certain amounts have been reclassified to improve the clarity and comparability of the financial statements. These reclassifications had no impact on previously reported total assets, liabilities, equity, net income (loss), or cash flows for any periods presented.
Business Segments
The Company uses the “management approach”
to identify its reportable segments. The management approach requires companies to report segment financial information consistent with
information used by management for making operating decisions and assessing performance as the basis for identifying the Company’s
reportable segments. The Company has identified one single reportable operating segment. The Company manages its business on the basis
of
Use of Estimates
Preparing financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and revenues and expenses during the reported period. Actual results could differ from those estimates, and those estimates may be material.
Changes in estimates are recorded in the period in which they become known. The Company bases its estimates on historical experience and other assumptions, which include both quantitative and qualitative assessments that it believes to be reasonable under the circumstances.
Significant estimates during the years ended December 31, 2025 and 2024 include valuation of stock-based compensation, uncertain tax positions, the fair value determination of investment in convertible preferred stock, fair value determination of derivative liability and the valuation allowance on deferred tax assets.
F-10
Emerging Growth Company Status
The Company is an emerging growth company, as defined by the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards that have different effective dates to public and private companies until the earlier of the date that (i) the company is no longer an emerging growth company or (ii) the company affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act. As a result, these consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. The Company expects to use the extended transition period for any other new or revised accounting standards during the period in which it remains an emerging growth company.
Fair Value of Financial Instruments
The Company accounts for financial instruments under Financial Accounting Standards Board (“FASB”) ASC 820, Fair Value Measurements. ASC 820 provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability.
The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires the Company to use observable inputs when available, and to minimize the use of unobservable inputs, when determining fair value.
The three tiers are defined as follows:
| ● | Level 1 – Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets; | |
| ● | Level 2 – Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and | |
| ● | Level 3 – Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions. |
The determination of fair value and the assessment of a measurement’s placement within the hierarchy requires judgment. Level 3 valuations often involve a higher degree of judgment and complexity. Level 3 valuations may require the use of various cost, market, or income valuation methodologies applied to unobservable management estimates and assumptions. Management’s assumptions could vary depending on the asset or liability valued and the valuation method used. Such assumptions could include estimates of prices, earnings, costs, actions of market participants, market factors, or the weighting of various valuation methods. The Company may also engage external advisors to assist us in determining fair value, as appropriate.
Although the Company believes that the recorded fair value of our financial instruments is appropriate, these fair values may not be indicative of net realizable value or reflective of future fair values.
The Company’s financial instruments are carried at historical cost. At December 31, 2025 and 2024, respectively, the carrying amounts of these instruments approximated their fair values because of the short-term nature of these instruments.
ASC 825-10 “Financial Instruments” allows entities to voluntarily choose to measure certain financial assets and liabilities at fair value (“fair value option”). The fair value option may be elected on an instrument-by-instrument basis and is irrevocable unless a new election date occurs. If the fair value option is elected for an instrument, unrealized gains and losses for that instrument should be reported in earnings at each subsequent reporting date. The Company did not elect to apply the fair value option to any outstanding financial instruments.
Investment in convertible preferred stock
The Company elected the measurement alternative for these investments without readily determinable fair values and for which the Company does not control or have the ability to exercise considerable influence over operating and financial policies.
The non-marketable equity securities are carried at cost less any impairment, adjusted for observable price changes of similar investments of the same issuer. On a annual basis, the Company performs a qualitative assessment to evaluate whether the investment is impaired. If there are sufficient indicators that the fair value of the investment is less than the carrying value, the carrying value of the investment is reduced and an impairment is recorded in the statements of operations as other expense.
At December 31, 2025 and 2024, the Company held
As this investment is valued at $
F-11
Cash and Cash Equivalents and Concentration of Credit Risk
For purposes of the statements of cash flows, the Company considers all highly liquid instruments with a maturity of three months or less at the purchase date and money market accounts to be cash equivalents.
At
December 31, 2025 and 2024, respectively, the Company had $
The Company is exposed to credit risk on its cash
and cash equivalents in the event of default by the financial institutions to the extent account balances exceed the amount insured by
the FDIC, which is $
At December 31, 2025 and 2024, the Company’s cash balances did exceed FDIC insured limit.
Inventory
Inventory consists solely of finished goods (swabs used in collection
kits) and is stated at the lower of cost or net realizable value, with cost determined using the first-in, first-out (FIFO) method. Management
evaluates inventory for excess and obsolescence on a annual basis by comparing on-hand quantities to historical and projected usage and
records write-downs to net realizable value as necessary. Inventory was $
Convertible Notes with Fixed Rate Conversion Options
The Company has entered into and, may enter into additional convertible notes, some of which may contain fixed rate conversion features, whereby the outstanding principal and accrued interest may be converted, by the holder, into common shares at a fixed discount to the price of the common stock at the time of conversion. The Company measures the fair value of the notes at the time of issuance.
The Company bifurcates conversion options from their host instruments and accounts for them as free-standing derivative financial instruments if certain criteria are met. The criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument.
Debt Discount
For certain notes issued, the Company may provide the debt holder with an original issue discount. The original issue discount is recorded as a debt discount, reducing the face amount of the note, and is amortized to interest expense over the life of the debt, in the Statements of Operations.
Debt Issuance Cost
Debt issuance cost paid to lenders, or third parties are recorded as debt discounts and amortized to interest expense over the life of the underlying debt instrument, in the Statements of Operations.
F-12
Derivative Financial Instruments
The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risks. The Company evaluated all of our financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported in the statements of operations. For our derivative financial instruments, the Company used a Black Scholes valuation model to value the derivative instruments at inception and on subsequent valuation dates. The classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is evaluated at the end of each reporting period. Derivative liabilities are classified in the balance sheet as current or non-current based on whether or not net-cash settlement or conversion of the instrument could be required within twelve (12) months of the balance sheet date.
Research and Development
The Company accounts for research and development costs in accordance with ASC subtopic 730-10, Research and Development (“ASC 730-10”).
Under ASC 730-10, all research and development costs must be charged to expense as incurred. Accordingly, internal research and development costs are expensed as incurred. Third-party research and development costs are expensed when the contracted work has been performed or as milestone results have been achieved as defined under the applicable agreement. Company-sponsored research and development costs related to both present and future products are expensed in the period incurred.
The Company incurred research and development
expenses of $
Income Taxes
The Company accounts for income tax using the asset and liability method prescribed by ASC 740, “Income Taxes”. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and tax bases of assets and liabilities using enacted tax rates that will be in effect in the year in which the differences are expected to reverse. The Company records a valuation allowance to offset deferred tax assets if based on the weight of available evidence, it is more-likely-than-not that some portion, or all, of the deferred tax assets will not be realized. The effect on deferred taxes of a change in tax rates is recognized as income or loss in the period that includes the enactment date.
The Company follows the accounting guidance for uncertainty in income taxes using the provisions of ASC 740 “Income Taxes”. Using that guidance, tax positions initially need to be recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities.
As of December 31, 2025 and 2024, respectively, the Company had uncertain tax positions that qualify for either recognition or disclosure in the financial statements.
The Company recognizes interest and penalties related to uncertain income tax positions in other expense. interest and penalties related to uncertain income tax positions were recorded during the years ended December 31, 2025 and 2024, respectively.
Due to the Company’s net operating loss posture, all tax years are open and subject to income tax examination by tax authorities.
F-13
Advertising Costs
Advertising and marketing costs are expensed as incurred. Advertising and marketing costs are included as a component of general and administrative expense in the statements of operations. Marketing and advertising costs primarily consisted of preparation of our go-to-market strategy, development of our consumer packaging and website design.
The Company recognized $
Stock-Based Compensation
The Company accounts for our stock-based compensation under ASC 718 “Compensation – Stock Compensation” using the fair value-based method. Under this method, compensation cost is measured at the grant date based on the value of the award and is recognized over the service period, which is usually the vesting period. This guidance establishes standards for the accounting for transactions in which an entity exchanges it equity instruments for goods or services. It also addresses transactions in which an entity incurs liabilities in exchange for goods or services that are based on the fair value of the entity’s equity instruments or that may be settled by the issuance of those equity instruments.
The Company uses the fair value method for equity instruments granted to non-employees and use the Black-Scholes model for measuring the fair value of options.
The fair value of stock-based compensation is determined as of the date of the grant or the date at which the performance of the services is completed (measurement date) and is recognized over the vesting periods.
When determining fair value, the Company considers the following assumptions in the Black-Scholes model:
| ● | Exercise price | |
| ● | Expected dividends, | |
| ● | Expected volatility, | |
| ● | Expected life of option |
Basic and Diluted Earnings (Loss) per Share
Pursuant to ASC 260-10-45, basic loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding for the periods presented. Diluted loss per share is computed by dividing net loss by the weighted average number of shares of common stock, common stock equivalents and potentially dilutive securities outstanding during the period. Potentially dilutive common shares may consist of common stock issuable for stock options and warrants (using the treasury stock method), convertible preferred stock, convertible notes and common stock issuable. These common stock equivalents may be dilutive in the future.
At December 31, 2025 and 2024, respectively, the Company had the following common stock equivalents, which are potentially dilutive equity securities:
| December 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Convertible Preferred Stock(1) | ||||||||
| Convertible notes | ||||||||
| Common stock issuable | ||||||||
| Warrant | ||||||||
| Total | ||||||||
| (1) |
For purposes of the diluted net loss per share calculation, warrants to purchase common stock and stock options are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented
F-14
Related Parties
Parties are considered to be related to the Company if the parties, directly or indirectly, through one or more intermediaries, control, are controlled by, or are under common control with the Company. Related parties also include principal owners of the Company, its management, members of the immediate families of principal owners of the Company and its management and other parties with which the Company may deal with if one party controls or can significantly influence the management or operating policies of the other to an extent that one of the transacting parties might be prevented from fully pursuing its own separate interests.
Recently Adopted Accounting Pronouncements
In June 2022, the FASB issued ASU 2022-03, ASC Subtopic “Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions”. These amendments clarify that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. The amendments in this update are effective for public business entities for fiscal years, including interim periods within those fiscal years, beginning after December 15, 2023. Early adoption is permitted.
This guidance was adopted on January 1, 2024. The adoption of ASU 2022-03 did not have a material impact on the Company’s consolidated financial statements.
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280). The amendments in this update expand segment disclosure requirements, including new segment disclosure requirements for entities with a single reportable segment among other disclosure requirements. This update is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. There was no impact on the Company’s financial statements as a result of the adoption of the standard.
Recently Issued Accounting Pronouncements Not Yet Adopted
Changes to accounting principles are established by the FASB in the form of Accounting Standards Updates (“ASU’s”) to the FASB’s Codification. We consider the applicability and impact of all ASU’s on our financial position, results of operations, stockholders’ deficit, cash flows, or presentation thereof. Management has evaluated all recent accounting pronouncements as issued by the FASB in the form of Accounting Standards Updates (“ASU”) through the date these financial statements were available to be issued and found the following recent accounting pronouncements issued, but not yet effective accounting pronouncements, are not expected to have a material impact on the financial statements of the Company.
In November 2024, the FASB issued ASU 2024-03, ASC Subtopic “Disaggregation of Income Statement Expenses (ASC 220-40): Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures”. The amendments require additional disclosure of the nature of expenses included in the income statement. The amendments in this update are effective for public business entities for fiscal years, beginning after December 15, 2026. Early adoption is permitted. The Company is currently assessing the impact of the adoption of this standard on its consolidated financial statements.
We do not expect the adoption of this pronouncement will have a material effect on the Company’s financial statements.
Note 3 – Discontinued Operations
On December 31, 2024, the Company entered into
a Stock Purchase Agreement (the “Exousia SPA”) with Marijuana, Inc., a publicly-traded Florida corporation (symbol: MAJI)
(“Purchaser”), pursuant to which Purchaser would purchase
The purchase price under the Exousia SPA for
F-15
As such, the Company recognized note receivable and investment in convertible preferred stock of MAJI as of December 31, 2024.
In October 2024, the Company dissolved the two subsidiaries, mRNA for Life, Inc. and Precision Genomics, Inc.
The above restructuring of subsidiaries will have an effect on the Company’s operations and financials results and this qualifies for presentation as a discontinued operation.
At December 31, 2025 and 2024, the Company had assets or liabilities classified as discontinued operation.
The following is a summary of discontinued operations for the years ended December 31, 2025 and 2024:
| Years Ended | ||||||||
| December 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenue | $ | $ | ||||||
| Operating Expenses: | ||||||||
| General and administration expenses | ||||||||
| Research and development | ||||||||
| Total operating expenses | $ | $ | ||||||
| Loss from discontinued operations | $ | $ | ( | ) | ||||
| Gain on sale of subsidiary | ||||||||
| Income from discontinued operation, net of tax | $ | $ | ||||||
The following is a summary of discontinued cash flows for the years ended December 31, 2025 and 2024:
| Years Ended | ||||||||
| December 31, | ||||||||
| Cash Flows from Operating Activities: | 2025 | 2024 | ||||||
| Net loss | $ | $ | ( | ) | ||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses | ||||||||
| Accounts payable | ||||||||
| Unearned fee | ||||||||
| Net Cash Used in Operating Activities | ( | ) | ||||||
| Cash Flows from Operating Activities: | ||||||||
| Proceeds received from parent company | ||||||||
| Repayments to parent company | ( | ) | ||||||
| Net Cash Used in Financing Activities | ( | ) | ||||||
| Net change in cash | ( | ) | ||||||
| Cash, beginning of period | ||||||||
| Cash, end of period | $ | $ | ||||||
| Supplemental disclosure of non-cash financing activity | ||||||||
| Forgiveness of loans from parent company | $ | $ | ||||||
F-16
Note 4 – Notes Payable and Convertible Notes Payable
Notes Payable - Net
Between June 2012 and October 2023, the Company
issued promissory notes to 13 individuals in the aggregate of $
Convertible Notes Payable - Net
The Company had the following activity related to its convertible notes payable:
| Balance - December 31, 2023 | $ | |||
| Proceeds (face amount of note) | ||||
| Guaranteed interest recorded to convertible note payable | ||||
| Original issue debt discount | ( | ) | ||
| Guaranteed interest – debt discount | ( | ) | ||
| Repayments including guaranteed interest | ( | ) | ||
| Amortization of debt discount | ||||
| Balance - December 31, 2024 | ||||
| Proceeds (face amount of note) | ||||
| Derivative liability recognized as debt discount | ( | ) | ||
| Amortization of debt discount | ||||
| Balance – December 31, 2025 | $ |
Convertible Notes Payable are summarized as follows:
Note issued in 2025
In January 2025, the Company entered into securities
purchase agreements (the “SPAs”) with 2 individuals, pursuant to which the Company agreed to issue to the Investors Promissory
Notes (the “Notes”), in the aggregate principal amount of $
In April and May 2025, the Company entered into
securities purchase agreements (the “SPAs”) with 7 individuals, pursuant to which the Company agreed to issue to the Investors
Promissory Notes (the “Notes”), in the aggregate principal amount of $
F-17
The Company valued the conversion feature using
the Black-Scholes pricing model. The fair value of the derivative liability for all the notes that became convertible with variable conversion
price during the year ended December 31, 2025 amounted to $
Notes issued in 2024
In February, 2024, the Company entered into a
securities purchase agreement (the “SPA”), pursuant to which the Company agreed to issue to the Investor a Promissory Note
(the “Note”), dated February 12, 2024, in the principal amount of $
Between March 2024 and November 2024, the Company
entered into securities purchase agreements (the “SPAs”) with 16 individuals in the aggregate of $
Modification and Extinguishment of Convertible Notes Payable
On April 3, 2025, the Company entered into Note
Extension and Modification Agreements with 11 of our Noteholders, extending the maturity dates on their Notes to December 31, 2025. The
conversion features of the notes were modified such that if, prior to the Maturity Date, the Company’s securities are accepted for
listing on a national securities exchange (an “Uplist”), then the outstanding principal and interest of the Notes shall automatically
convert into Common Stock, at a conversion price equal to: (a) if in connection with the Uplist the Company issues and sells shares of
its Common Stock, or securities convertible into or exchangeable for shares of Common Stock, whether in a public offering or a private
placement, eighty-five percent (
F-18
On April 3, 2025 the Company evaluated the modification
of terms under ASC 470-50, “Debt - Modification and Extinguishment”, and concluded that the extension of the maturity
dates did not result in significant change, however, the amendment of conversion price was fundamentally different from the existing debt
and resulted in an extinguishment of the debt. Accordingly, the Company recorded a loss on extinguishment of debt of $
In January 2026, the Company extended the maturity dates of all notes
listed above to March 31, 2026. The Company evaluated the modification of terms and concluded that the extension of the maturity dates
did not result in significant and consequential changes to the economic substance of the debt, and thus resulted in a modification of
the debt and not an extinguishment of the debt. Specifically, on the date of modification, the Company determined that the present value
of the cash flows of the modified debt instruments were less than
Inducements
In March 2024, the Company recorded
In July 2024, the Company entered into agreements with 16 noteholders,
extending the maturity on their notes to October 1, 2024. In consideration thereof, each noteholder received a warrant to purchase
In October 2024, the Company entered into agreements with 16 noteholders, extending the maturity on their note to April 1, 2025.
In October 2024, the Company entered into agreements with 1 noteholder,
extending the maturity on their note to April 1, 2025. In consideration thereof, the noteholder received
Interest expense and amortization of debt discount
During the years ended December 31, 2025, and
2024, the Company recorded interest expense for notes payable and convertible notes of $
During the years ended December 31, 2025, and
2024, the Company recorded amortization of debt discount of $
F-19
Note 5 – Derivative liability
Fair Value Assumptions Used in Accounting for Derivative Liabilities
ASC 815 requires us to assess the fair market value of derivative liabilities at the end of each reporting period and recognize any change in the fair market value as other income or expense. The Company determined our derivative liabilities to be a Level 3 fair value measurement and used the Black-Scholes pricing model to calculate the fair value as of April, 3, 2025, issuance date of convertible notes and December 31, 2025.
The Black-Scholes model, which requires six basic data inputs: the exercise or strike price, time to expiration, the risk-free interest rate, the current stock price, the estimated volatility of the stock price in the future, and the dividend rate. Changes to these inputs could produce a significantly higher or lower fair value measurement. The current stock price is based on the Company’s stock price. Expected volatility is based on the historical stock price volatility of the Companies’ common stock. Risk free interest rates were obtained from U.S. Treasury rates for the applicable periods.
During the year ended December 31, 2025, in connection with the convertible
notes payable and a conversion feature which converts into common shares at the Liquidity Event, the Company determined our derivative
liability feature from the noteholder’s conversion for the convertible notes is not clearly and closely related to the host and
accounted for it as a bifurcated derivative liability. As a result, the Company calculated the derivative liability based on the conditional
liquidity event, the IPO or the Maturity. As of December 31, 2025, the pricing of the IPO was assumed to be between $
As of the date of issuance of the convertible notes and December 31, 2025, the estimated fair values of the liabilities measured on a recurring basis were based on the following Black Scholes inputs:
| Initial | December 31, | |||||||
| Date | 2025 | |||||||
| Expected conversion price | $ | $ | ||||||
| Expected term | ||||||||
| Expected average volatility | ||||||||
| Expected dividend yield | ||||||||
| Risk-free interest rate | ||||||||
| Expected IPO Price | $ | $ |
The following table summarizes the changes in the derivative liabilities during the years ended December 31, 2025 and 2024:
| Fair Value Measurements Using Significant Unobservable Inputs (Level 3) | ||||
| Balance - December 31, 2024 | ||||
| Initial recognition of derivative liability - conversion feature | ||||
| Loss on extinguishment of derivative liability | ||||
| Gain on change in fair value of the derivative | ( | ) | ||
| Balance - December 31, 2025 | $ | |||
F-20
Note 6 – Commitments and Contingencies
On November 15, 2023, we entered into a Financial
Advisory Services Agreement with Thornhill Advisory Group, Inc. (f/k/a EverAsia Financial Group, Inc.), a financial consulting firm owned
by Scott J. Silverman, who, in conjunction with the execution the CFO Agreement, was appointed as our Chief Financial Officer. Under the
CFO Agreement, the Company is obligated to make monthly payments of $
Beginning from the execution date of the CFO Agreement
and continuing until the Company raises $
| Funds Raised | Paid Monthly | Accrued Monthly | ||||||
| $0 – $250,000 | $ | $ | ||||||
| $250,000 – $750,000 | $ | $ | ||||||
Upon the Company’s raising of $
On April 1, 2024, Jose Antonio Reyes. signed an
Offer Letter for his employment as our Chief Operating Officer. In September 2024, Mr. Reyes was named as our Chief Executive Officer.
In Pursuant to the terms of his employment, the Company is obliged to make monthly payments to Mr. Reyes of $
Beginning from the execution date of the Offer
Letter and continuing until the Company raises $
| Funds Raised | Paid Monthly |
Accrued Monthly |
||||||
| $0 – $250,000 | $ | $ | ||||||
| $250,000 – $750,000 | $ | $ | ||||||
Upon the Company’s raising of $
On April 1, 2024, Marvin S.
Hausman., M.D. signed an Offer Letter for his employment as our Chief Science Officer. Additionally, Dr. Hausman served as our Chairman
of the Board of Directors until he resigned in April 2025. Pursuant to the terms of his employment, the Company is obliged to make monthly
payments to Dr. Hausman of $
Beginning from the execution
date of the Offer Letter and continuing until the Company raises $
| Funds Raised | Paid Monthly | Accrued Monthly | ||||||
| $0 – $250,000 | $ | $ | ||||||
| $250,000 – $750,000 | $ | $ | ||||||
Upon the Company’s
raising of $
F-21
From September 5, 2023 until
April 1, 2024, Marvin S. Hausman, M.D., served as our Chief Executive Officer. Under his employment agreement, we paid Dr. Hausman $
As of December 31, 2025 and
2024, the Company has accrued $
In August 2024, the Company acquired patent pending (“Patent”)
for an mRNA Neuro Panel and Serotonin Assay, which Patent was lodged by Nova on or about April 26, 2024, as U.S. Patent Application 18/705375,
International Publication Number WO 2023/077245, captioned as “Diagnosing, Monitoring and Treating Neurological Disease with Psychoactive
Tryptamine Derivatives and mRNA Measurements” (“IP” or “Patent”) from Nova Mentis Life Science Corp. in
exchange for the issuance of
Note 7 – Stockholders’ Deficit
The Company has two (2) classes of stock:
Common Stock
| ● | ||
| ● | $ | |
| ● | Voting at |
At December 31, 2025 and 2024, the Company had
Preferred Stock
In May 2022 and December 2022, the Company’s
Articles of Incorporation, as amended, authorized the issuance of
The Board of Directors has made the following designations of its preferred stock.
F-22
Series A, Convertible Preferred Stock
| ● | ||
| ● | $ | |
| ● | Conversion feature – each share of preferred stock is convertible into
| |
| ● | Voting – on an as converted basis with common stock, at the applicable
conversion rate ( | |
| ● | Dividends – accrued only upon declaration of the board of directors, at the applicable conversion rate. | |
| ● | Mandatorily redeemable (automatic conversion) on January 1, 2025. (See below amendment) | |
| ● | Anti-dilution provision – rights exist for the period of two years
after the convertible preferred shares were converted into common stock. Additionally, holders of the convertible preferred stock will
have full ratchet anti-dilution protection rights at the rate of |
In connection with the issuance of these Series A, convertible preferred shares, the Company determined that there were no provisions within ASC 815 that were met, which would require derivative liability accounting treatment. Specifically, as noted below, upon amending the terms of the Series A, convertible preferred stock, at that time, there had been no new stock issuances of any type which may have triggered the anti-dilution provision.
In December 2022, the Company amended its articles of incorporation related to certain terms of its Series A, convertible preferred stock. At that time, the Company, along with approval from its convertible preferred stockholders agreed to remove provisions related to mandatory redemption as well as anti-dilution rights.
At December 31, 2025 and 2024, the Company had
Equity Transactions for the Year Ended December 31, 2024
During the year ended December 31, 2024, the Company
issued
| ● | ||
| ● | ||
| ● | ||
| ● |
During the year ended December 31, 2024, the Company
issued
F-23
During the year ended December 31, 2024, the Company
issued
| ● | ||
| ● |
Equity Transactions for the Year Ended December 31, 2025
On February 5, 2025, the Company issued
On August 28, 2025, the Company issued
Note 8 – Warrants
In February 2024, the Company issued
In July 2024, the Company issued
A summary of activity of the warrants during the years ended December 31, 2025, and 2024 is follows:
| Number of Warrants Outstanding | Weighted price | Weighted Average Remaining life (year) | ||||||||||
| Outstanding at December 31, 2023 | $ | |||||||||||
| Grant | ||||||||||||
| Exercised | - | |||||||||||
| Cancelled | - | |||||||||||
| Outstanding at December 31, 2024 | $ | |||||||||||
| Grant | - | |||||||||||
| Exercised | - | |||||||||||
| Cancelled | - | |||||||||||
| Outstanding at December 31, 2025 | $ | |||||||||||
| Exercisable at December 31, 2025 | $ | |||||||||||
The aggregate intrinsic value of the warrants as of December 31, 2025
and 2024 was $
F-24
Valuation
The Company utilizes the Black-Scholes model to value its warrants
at the date of issuance of warrants.
| December 31, 2024 | ||||
| Expected term (in years) | ||||
| Expected average volatility | % | |||
| Expected dividend yield | ||||
| Risk-free interest rate | | % | ||
| Weighted average fair value of warrants | $ |
Note 9 – Related party transactions
The Company had the following activity related to its due to related party:
| December 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Due on demand loan with | $ | $ | ||||||
| Note payable ( | ||||||||
| Note payable ( | ||||||||
| $ | $ | |||||||
In August 2024, The Company and Nova Mentis entered
into a royalty agreement requiring payment of
In December, 2024, the Company issued a Promissory
Note to our former chief executive officer, Jose Antonio Reyes in the principal amount of $
On March 10, 2025, the Company issued a Promissory
Note to our former chief executive officer, Charles Todd, in the principal amount of $
In November, 2025, the Company issued Promissory
Notes to Thornhill Advisory Group (“Thornhill”), a company beneficially owned by our Chief Financial Officer, in the principal
amount of $
In December, 2025, the Company issued Promissory
Notes to Thornhill for $
During the years ended December 31, 2025 and
2024, the Company recorded interest expense related to related party notes of $
During the years ended December 31, 2025 and 2024,
our former CEO, Mr. Todd, paid operating expense of $
During the years ended December 31, 2025 and 2024,
the Company paid Thornhill, $
During the years ended December 31, 2025 and 2024,
the Company paid to Jose Antonio Reyes, our Interim Chief Executive Officer, $
F-25
Note 10 – Income Taxes
The Company’s tax expense differs from the
“expected” tax expense for the period (computed by applying the blended corporate and state tax rates of
| December 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Federal income tax benefit–- | $ | ( | ) | $ | ( | ) | ||
| State income tax–- | ( | ) | ( | ) | ||||
| Non-deductible items | ||||||||
| Subtotal | ( | ) | ( | ) | ||||
| Change in valuation allowance | ||||||||
| Income tax benefit | $ | $ | ||||||
The tax effects of temporary differences that give rise to significant portions of deferred tax assets and liabilities at December 31, 2025 and 2024 are approximately as follows:
Schedule of Deferred Tax Assets and Liabilities
| December 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Amortization of debt discount | $ | $ | ( |
) | ||||
| Unpaid Liabilities | ( |
) | ||||||
| Share based payments | ( |
) | ||||||
| Net operating lass carryforwards | ( |
) | ( |
) | ||||
| Total deferred Tax assets | ( |
) | ( |
) | ||||
| Less valuation allowance | ||||||||
| Net deferred tax asset recorded | $ | $ | ||||||
Deferred tax assets and liabilities are computed by applying the federal and state income tax rates in effect to the gross amounts of temporary differences and other tax attributes, such as net operating loss carryforwards. In assessing if the deferred tax assets will be realized, the Company considers whether it is more likely than not that some or all of these deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the period in which these deductible temporary differences reverse.
During the year ended December 31, 2025, the valuation
allowance increased by approximately $
At December 31, 2025, the Company has federal
net operating loss carryforwards, which are available to offset future taxable income, of approximately $
NOL carryforwards that were generated after 2017
of approximately $
These carryforwards may be subject to an annual
limitation under Section 382 and 383 of the Internal Revenue Code of 1986, and similar state provisions if the Company experienced one
or more ownership changes which would limit the amount of NOL and tax credit carryforwards that can be utilized to offset future taxable
income and tax, respectively. In general, an ownership change, as defined by Section 382 and 383, results from transactions increasing
ownership of certain stockholders or public groups in the stock of the corporation by more than
F-26
If eliminated, the related asset would be removed from the deferred tax asset schedule with a corresponding reduction in the valuation allowance. Due to the existence of the valuation allowance, limitations created by future ownership changes, if any, will not impact the Company’s effective tax rate.
The Company files corporate income tax returns in the United States and Florida jurisdictions. Due to the Company’s net operating loss posture, all tax years are open and subject to income tax examination by tax authorities. The Company’s policy is to recognize interest expense and penalties related to income tax matters as tax expense. At December 31, 2025 and 2024, respectively, there were no unrecognized tax benefits, and there are no significant accruals for interest related to unrecognized tax benefits or tax penalties.
Note 11 – Segment Reporting
The or Interim CEO (“CEO”) is the chief operating decision maker (“CODM”) who reviews financial information on a consolidated basis for purposes of allocating resources and evaluating financial performance. Accordingly, we determined we operate in a reporting segment – developing products that use mRNA genetic biomarkers to potentially assess the occurrence of inflammation, and, as a result, inflammation related chronic diseases. Within this segment, our products will be sold into the Medical markets.
Note 12 – Subsequent Events
On February 5, 2026, the Company entered into
a securities purchase agreement (the “SPA”), pursuant to which the Company agreed to issue to the Investor a Promissory Note
(the “Note”), dated February 5, 2026, in the principal amount of $
In connection with the Note, the Company also
issued a warrant to purchase up to $
On February 5, 2026, the Company repaid a related
party promissory note to Thornhill Advisory Group (“Thornhill”), a company beneficially owned by our Chief Financial Officer,
in the principal amount of $
On February 5, 2026, the Company repaid a related
party promissory note to Thornhill for $
On February 26, 2026, pursuant to a certain Securities
Exchange Agreement (“SEA”), the Company agreed to exchange
If, (a) on the expiration date of the
Leak-Out Period, the closing price of LMMY’s common stock, as reported on OTCMarkets.com, shall be less than $
On March 12, 2026, the Company and its former CEO, Charles Todd, Jr.,
entered into an agreement whereby the Company will pay to Mr. Todd $
F-27