Cardio Diagnostics Holdings, Inc.

Previous wording

Cardio launched its first clinical test, Epi+Gen CHD™, a three-year symptomatic CHD risk assessment clinical blood test targeting CHD events, including heart attacks, in 2021 during the Covid-19 pandemic. As a result, the initial strategy for commercialization involved launching the test via telemedicine and in smaller provider practices such as concierge medicine practices. The volume of tests through these channels were minimal, and as the circumstances around Covid-19 pandemic improved, management re-vamped the Company’s go-to-market strategy to include other healthcare verticals and stakeholders beyond patients and small providers, including larger provider organizations, group purchasing organizations, employers, payors and life insurers. This new approach allowed Cardio to expand the reach of our solutions beyond the initial focus areas. Beyond the launch of Epi+Gen CHD, in March 2023, we announced the launch of our second product, PrecisionCHD™, an integrated epigenetic-genetic clinical blood test for the detection of coronary heart disease. The Epi+Gen CHD™ and PrecisionCHD™ tests are coupled to Actionable Clinical Intelligence (“ACI”), a platform that offers new epigenetic and genetic insights to clinicians prescribing the to personalize patient management and help improve chronic care management. In May 2023, we launched CardioInnovate360™, a research-use-only (“RUO”) solution to support the discovery, development and validation of novel biopharmaceuticals for the assessment and management of cardiovascular diseases. In February 2024, we announced the launch of HeartRisk™, a cardiovascular disease risk intelligence platform. We believe that our Epi+Gen CHD™ and PrecisionCHD™ tests are categorized as laboratory-developed tests, or “LDTs.” The new go-to-market strategy is also being implemented for these products. Despite long partnership and sales cycles, in some instance as long as 14 months, Cardio was able to increase the reach of its solutions in 2024, generating revenue from provider organizations and has continued the development of a more robust sales and partnership pipeline. To further increase reach and potentially accelerate partnerships and sales cycles, more seasoned sales personnel in the provider and employer verticals were hired in late 2024. In Q1 and Q2 2025, the focus of the Company remained in driving adoption of our clinical solutions, predominantly among providers, channel partners and employers. In addition, the Company made progress in the Medicare reimbursement process where the Company received preliminary gapfill pricing from the Centers for Medicare and Medicaid for the Epi+Gen CHD and PrecisionCHD tests, onboarding a new employer client and in setting up our laboratory facility.

Current wording

Cardio launched its first clinical test, Epi+Gen CHD™, a three-year symptomatic CHD risk assessment clinical blood test targeting CHD events, including heart attacks, in 2021 during the Covid-19 pandemic. As a result, the initial strategy for commercialization involved launching the test via telemedicine and in smaller provider practices such as concierge medicine practices. The volume of tests through these channels were minimal, and as the circumstances around Covid-19 pandemic improved, management re-vamped the Company’s go-to-market strategy to include other healthcare verticals and stakeholders beyond patients and small providers, including larger provider organizations, group purchasing organizations, employers, payors and life insurers. This new approach allowed Cardio to expand the reach of our solutions beyond the initial focus areas. Beyond the launch of Epi+Gen CHD, in March 2023, we announced the launch of our second product, PrecisionCHD™, an integrated epigenetic-genetic clinical blood test for the detection of coronary heart disease. The Epi+Gen CHD™ and PrecisionCHD™ tests are coupled to Actionable Clinical Intelligence (“ACI”), a platform that offers new epigenetic and genetic insights to clinicians prescribing the to personalize patient management and help improve chronic care management. In May 2023, we launched CardioInnovate360™, a research-use-only (“RUO”) solution to support the discovery, development and validation of novel biopharmaceuticals for the assessment and management of cardiovascular diseases. In February 2024, we announced the launch of HeartRisk™, a cardiovascular disease risk intelligence platform. We believe that our Epi+Gen CHD™ and PrecisionCHD™ tests are categorized as laboratory-developed tests, or “LDTs.” The new go-to-market strategy is also being implemented for these products. Despite long partnership and sales cycles, in some instance as long as 14 months, Cardio has been able to increase the number of provider organizations offering its tests and has continued the development of a more robust sales and partnership pipeline. In the nine months ended September 30, 2025, the focus of the Company remained in driving adoption of our clinical solutions, predominantly among providers, channel partners and employers. In addition, the Company made progress in its ongoing expansion to additional markets such as the VA and international, partnering with the YMCA of East Tennessee to offer testing to its members and community, and in setting up our laboratory facility.

Previous wording

Cardio expects that sales and partnership cycles will continue to be long. Our ongoing strategy for expanding our business operations and increasing revenue generation include the following:

Current wording

Cardio expects that sales and partnership cycles will continue to be long, especially with the current economic uncertainty. Our ongoing strategy for expanding our business operations and increasing revenue generation include the following:

Previous wording

As of August 14, 2025, the Company sold 1,054,841 shares of its Common Stock on a Reverse Stock Split-adjusted basis under the Sales Agreement resulting in proceeds to the Company of $14,782,871, net of offering costs. The Company has paid Craig-Hallum $379,048 in sales commissions.

Current wording

As of November 12, 2025, the Company sold 1,117,763 shares of its Common Stock on a Reverse Stock Split-adjusted basis under the Sales Agreement resulting in proceeds to the Company of $15,061,270, net of offering costs. The Company has paid Craig-Hallum $386,186 in sales commissions.

Previous wording

On May 6, 2024, FDA published a final rule amending the definition of an in vitro diagnostic (“IVD”) device to include tests manufactured by a clinical laboratory. Pursuant to the rule, laboratory developed tests (“LDTs”), i.e., tests designed, manufactured, and used within a single CLIA-certified high complexity laboratory, are medical devices subject to FDA regulation under the Federal Food, Drug, and Cosmetic Act. The final rule also announced FDA’s intention to apply its medical device requirements to LDTs. Under the final rule, all LDTs, unless subject to a specific exemption, will be subject to premarket authorization requirements (510(k), de novo classification, or PMA) for each LDT performed by the laboratory, and to postmarket registration and listing, medical device reporting, correction, removal, and recall, complaint handling, labeling, investigational device, and quality system requirements. FDA intends to phase in these requirements beginning May 6, 2025. The final rule states that certain categories of LDTs will be subject to enforcement discretion with respect to some or all of these requirements. For example, FDA will apply enforcement discretion to currently marketed LDTs that were first offered prior to May 6, 2024, with respect to most quality system requirements and the requirement for premarket authorization if they are not modified or modified in only limited ways. Laboratories performing these tests are subject to other requirements, including the requirement to submit the labeling for the LDT to FDA for review. FDA will similarly exercise enforcement discretion with respect to premarket authorization for LDTs approved by the New York State Clinical Laboratory Evaluation Program (“NYS-CLEP”).

Current wording

On May 6, 2024, FDA published a final rule amending the definition of an in vitro diagnostic (“IVD”) device to include tests manufactured by a clinical laboratory. Pursuant to the rule, laboratory developed tests (“LDTs”), i.e., tests designed, manufactured, and used within a single CLIA-certified high complexity laboratory, are medical devices subject to FDA regulation under the Federal Food, Drug, and Cosmetic Act. The final rule also announced FDA’s intention to apply its medical device requirements to LDTs. Under the final rule, all LDTs, unless subject to a specific exemption, would be subject to premarket authorization requirements (510(k), de novo classification, or PMA) for each LDT performed by the laboratory, and to postmarket registration and listing, medical device reporting, correction, removal, and recall, complaint handling, labeling, investigational device, and quality system requirements. FDA intends to phase in these requirements beginning May 6, 2025. The final rule stated that certain categories of LDTs would be subject to enforcement discretion with respect to some or all of these requirements. For example, FDA would apply enforcement discretion to currently marketed LDTs that were first offered prior to May 6, 2024, with respect to most quality system requirements and the requirement for premarket authorization if they are not modified or modified in only limited ways. Laboratories performing these tests are subject to other requirements, including the requirement to submit the labeling for the LDT to FDA for review. FDA would similarly exercise enforcement discretion with respect to premarket authorization for LDTs approved by the New York State Clinical Laboratory Evaluation Program (“NYS-CLEP”).

Previous wording

The following table presents summary of consolidated operating results for the six-month periods indicated:

Current wording

The following table presents summary of consolidated operating results for the nine-month periods indicated:

Previous wording

Cardio’s net loss for the three months ended June 30, 2025 was $1,683,199 as compared to $1,287,995 for the three months ended June 30, 2024, an increase of $395,204. The increase in net loss was primarily the result of an increase in Selling, General and Administrative expenses associated with an increase in personnel in 2025.

Current wording

Cardio’s net loss for the three months ended September 30, 2025 was $1,714,536 as compared to $1,412,566 for the three months ended September 30, 2024, an increase of $301,970. The increase in net loss was primarily the result of an increase in Selling, General and Administrative expenses associated with an increase in personnel and professional fees in 2025.

Previous wording

Cardio’s net loss for the six months ended June 30, 2025 was $3,318,263 as compared to $5,451,579 for the six months ended June 30, 2024, a decrease of $2,133,316. The decrease in net loss was primarily the result of a decrease in General and Administrative expenses associated with stock compensation issued in 2024.

Current wording

Cardio’s net loss for the nine months ended September 30, 2025 was $5,032,799 as compared to $6,864,145 for the nine months ended September 30, 2024, a decrease of $1,831,346. The decrease in net loss was primarily the result of a decrease in General and Administrative expenses associated with stock compensation issued in 2024.

Previous wording

Cardio had $7,475 and $7,870 in revenue for the three months ended June 30, 2025 and 2024, respectively.

Current wording

Cardio had $2,855 and $6,580 in revenue for the three months ended September 30, 2025 and 2024, respectively.

Previous wording

Cardio had $8,415 and $23,798 in revenue for the six months ended June 30, 2025 and 2024, respectively. The decrease in revenue was noted in Q1 as a result of the conclusion of the Family Medicine Specialists’ Heart Attack Prevention testing initiative. Additional providers have been and are continuing to be onboarded as noted by Q2 revenue.

Current wording

Cardio had $11,270 and $30,378 in revenue for the nine months ended September 30, 2025 and 2024, respectively. The decrease in revenue is a result of the conclusion of the Family Medicine Specialists’ Heart Attack Prevention testing initiative.

Previous wording

Selling, General and Administrative Expenses for the three months ended June 30, 2025, were $1,686,174 as compared to $1,290,330 for the three months ended June 30, 2024, an increase of $395,844. The overall increase was primarily due to an increase in legal and professional expenses, payroll related expenses due to more personnel in 2025, research and development expenses and sales and marketing expenses.

Current wording

Selling, General and Administrative Expenses for the three months ended September 30, 2025, were $1,714,452 as compared to $1,415,547 for the three months ended September 30, 2024, an increase of $298,905. The overall increase was primarily due to an increase in personnel, legal and professional expenses, consulting and contractor expenses, research and development expenses and sales and marketing expenses.

Previous wording

Selling, General and Administrative Expenses for the six months ended June 30, 2025, were $3,317,674 as compared to $5,464,306 for the six months ended June 30, 2024, a decrease of $2,146,632. The overall decrease is primarily due to stock compensation expenses of $2,546,135 in the six months of 2024 as compared to $61,390 in the same period of 2025, offset by more payroll related expenses due to more personnel in 2025.

Current wording

Selling, General and Administrative Expenses for the nine months ended September 30, 2025, were $5,032,126 as compared to $6,879,853 for the nine months ended September 30, 2024, a decrease of $1,847,727. The overall decrease is primarily due to stock compensation expenses of $2,568,753 in the nine months of 2024 as compared to $86,152 in the same period of 2025, offset by more payroll related expenses due to more personnel in 2025.

Previous wording

We expect our general corporate overhead to remain relatively flat. However, we expect an increase in payroll and related costs and other facility costs, including furnishing the laboratory facility, capital expenditure of laboratory equipment, and other laboratory materials, in order to put our company laboratory into operation in the second half of 2025. Additionally, as a public company, we expect to have to comply with changing legal and exchange requirements, including as to regulations of the SEC and the continued listing requirements of the Nasdaq Capital Market. We incur additional annual expenses related to these matters and, among other things, additional directors’ and officers’ liability insurance, directors’ fees, reporting requirements of the SEC, transfer agent fees, increased auditing and legal fees and similar expenses.

Current wording

We expect our general corporate overhead to remain relatively flat. However, we expect an increase in payroll and related costs and other facility costs, including furnishing the laboratory facility, capital expenditure of laboratory equipment, and other laboratory materials, in order to put our company laboratory into operation in the fourth quarter of 2025. Additionally, as a public company, we expect to have to comply with changing legal and exchange requirements, including as to regulations of the SEC and the continued listing requirements of the Nasdaq Capital Market. We incur additional annual expenses related to these matters and, among other things, additional directors’ and officers’ liability insurance, directors’ fees, reporting requirements of the SEC, transfer agent fees, increased auditing and legal fees and similar expenses.

Previous wording

Total other expense for the three months ended June 30, 2025, was $(4,500) as compared to $(5,535) for the three months ended June 30, 2024. The total other expense for the three months ended June 30, 2025, consists of interest expense of $4,690, net of interest income of $190. The total other expense for the three months ended June 30, 2024, consists of interest expense of $5,817, net of interest income of $282.

Current wording

Total other expense for the three months ended September 30, 2025, was $(2,939) as compared to $(3,599) for the three months ended September 30, 2024. The total other expense for the three months ended September 30, 2025, consists of interest expense of $3,128, net of interest income of $189. The total other expense for the three months ended September 30, 2024, consists of interest expense of $3,879, net of interest income of $280.

Previous wording

Total other expense for the six months ended June 30, 2025, was $(9,004) as compared to $(11,071) for the six months ended June 30, 2024. The total other expense for the six months ended June 30, 2025, consists of interest expense of $9,381, net of interest income of $377. The total other expense for the six months ended June 30, 2024, consists of interest expense of $11,634, net of interest income of $563.

Current wording

Total other expense for the nine months ended September 30, 2025, was $(11,943) as compared to $(14,670) for the nine months ended September 30, 2024. The total other expense for the nine months ended September 30, 2025, consists of interest expense of $12,509, net of interest income of $566. The total other expense for the nine months ended September 30, 2024, consists of interest expense of $15,513, net of interest income of $843.

Previous wording

As of August 14, 2025, we sold 1,054,841 shares of our Common Stock on a Reverse Stock Split-adjusted basis under the Sales Agreement resulting in proceeds to us of $14,782,871, net of offering costs. We have paid Craig-Hallum $379,048 in sales commissions.

Current wording

As of November 12, 2025, the Company sold 1,117,763 shares of its Common Stock on a Reverse Stock Split-adjusted basis under the Sales Agreement resulting in proceeds to the Company of $15,061,270, net of offering costs. The Company has paid Craig-Hallum $386,186 in sales commissions.

Previous wording

On February 2, 2024, we closed a private placement with seven accredited investors, whereby we issued a total of 18,727 (561,793 prior to the Reverse Stock Split) units (“Units”), with each Unit consisting of (i) one share of our Common Stock and (ii) one six-year Common Stock purchase warrant having an exercise price of $53.40 ($1.78 prior to the Reverse Stock Split) per share, subject to adjustment (the "Private Placement”). The Private Placement resulted in the issuance to investors of 18,727 (561,793 prior to the Reverse Stock Split) shares of Common Stock and 18,727 (561,793 prior to the Reverse Stock Split) warrants in an unregistered offering of securities. The purchase price of the securities was $53.40 ($1.78 prior to the Reverse Stock Split) Unit, resulting in gross proceeds to the Company of $1,000,000, before deducting placement agent fees (10% or $100,000) and other offering expenses. We used the net proceeds from the Private Placement for working capital and general corporate purposes. We have subsequently registered the Private Placement Common Stock and the Common Stock issuable upon the exercise of the Private Placement Warrants on a registration statement on Form S-1 that was declared effective by the SEC on December 3, 2024.

Current wording

On February 2, 2024 (pre-dating the 1-for-30 reverse stock split effected in May 2025), in accordance with executed subscription agreements with seven accredited investors (the “Subscription Agreements”), we closed on the sale of 561,793 units (the “Units”), with each Unit consisting of (i) one share of the Company’s common stock, $0.00001 par value (the “Common Stock”) and (ii) one six year Common Stock purchase warrant (the “Warrants”), which warrants are exercisable until February 2, 2030 at an exercise price of $1.78 ($53.40 on a post-reverse stock split basis) per share, subject to adjustment for stock splits, reverse stock splits and other similar events of recapitalization, including the 1-for-30 reverse stock split we effected on May 12, 2025. The Units were sold to the investors in a private placement at a sale price of $1.78 ($53.40 on a post-reverse stock split basis) per Unit (the “Private Placement”), resulting in gross proceeds to the Company of $1,000,000, before deducting placement agent fees (10% or $100,000) and other offering expenses. We used the net proceeds from the Private Placement for working capital and general corporate purposes. On a post-reverse stock split basis, the Company issued 18,727 shares and warrants that are exercisable for 18,727 shares, all at an exercise price of $53.40 per share. We have subsequently registered the Private Placement Common Stock and the Common Stock issuable upon the exercise of the Private Placement Warrants on a registration statement on Form S-1 that was declared effective by the SEC on December 3, 2024 and subsequently on September 19, 2025.

Previous wording

At the upcoming 2025 annual meeting of stockholders, our stockholders will be asked to approve the future issuance of shares of Common Stock and/or securities convertible into or exercisable for Common Stock equal to 20% or more of the Common Stock outstanding in one or more non-public transactions as required by Nasdaq Marketplace Listing Rule 5635(d) (the "Share Issuance Proposal”). This proposal is identical to the proposals approved by our stockholders in 2023 and 2024, neither of which we relied upon for financing options, and the authorizations provided thereby expired. Any non-public financing transaction undertaken in connection with this approval will be conducted within the parameters set forth in the Share Issuance Proposal described in the proxy statement for the 2025 annual meeting, if the proposal is approved. We currently have no specific plans for such an offering but believe having that option available provides our Board of Directors with added flexibility in meeting the Company’s liquidity needs.

Current wording

At our 2025 annual meeting of stockholders, our stockholders approved the future issuance of shares of Common Stock and/or securities convertible into or exercisable for Common Stock equal to 20% or more of the Common Stock outstanding in one or more non-public transactions as required by Nasdaq Marketplace Listing Rule 5635(d) (the "Share Issuance Proposal”). This proposal was identical to the proposals approved by our stockholders in 2023 and 2024, neither of which we relied upon for financing options, and the authorizations provided thereby expired. Any non-public financing transaction undertaken in connection with this approval will be conducted within the parameters set forth in the Share Issuance Proposal described in the proxy statement for the 2025 annual meeting. We currently have no specific plans for such an offering but believe having that option available provides our Board of Directors with added flexibility in meeting the Company’s liquidity needs.

Previous wording

The exercise prices of our currently outstanding warrants range from a high of $345 to a low of $53.40 (a high of $11.50 to a low of $1.78 before the Reverse Stock Split) (subject to adjustment) per share of Common Stock. The likelihood that warrant holders will exercise their warrants, and therefore the amount of cash proceeds that we might receive, is dependent upon the trading price of our Common Stock, the last reported sales price for which was $3.82 on August 13, 2025. If the trading price of our Common Stock is less than the respective exercise prices of our outstanding warrants, which has been the case for a substantial period of time, we believe holders of any of our warrants will be unlikely to exercise their warrants. There is no guarantee that the warrants will be in the money prior to their respective expiration dates, and as such, the warrants may expire worthless, and we may receive no proceeds from the exercise of warrants. Given the current differential between the trading price of our Common Stock and the Warrant exercise prices and the volatility of our stock price, we are not making strategic business decisions based on an expectation that we will receive any cash from the exercise of warrants. However, we will use any cash proceeds received from the exercise of warrants for general corporate and working capital purposes, which would increase our liquidity. We will continue to evaluate the probability of warrant exercises and the merit of including potential cash proceeds from the exercise of the warrants in our future liquidity projections.

Current wording

The exercise prices of our currently outstanding warrants range from a high of $345 to a low of $53.40 (a high of $11.50 to a low of $1.78 before the Reverse Stock Split) (subject to adjustment) per share of Common Stock. The likelihood that warrant holders will exercise their warrants, and therefore the amount of cash proceeds that we might receive, is dependent upon the trading price of our Common Stock, the last reported sales price for which was 3.86 on November 10, 2025. If the trading price of our Common Stock is less than the respective exercise prices of our outstanding warrants, which has been the case for a substantial period of time, we believe holders of any of our warrants will be unlikely to exercise their warrants. There is no guarantee that the warrants will be in the money prior to their respective expiration dates, and as such, the warrants may expire worthless, and we may receive no proceeds from the exercise of warrants. Given the current differential between the trading price of our Common Stock and the Warrant exercise prices and the volatility of our stock price, we are not making strategic business decisions based on an expectation that we will receive any cash from the exercise of warrants. However, we will use any cash proceeds received from the exercise of warrants for general corporate and working capital purposes, which would increase our liquidity. We will continue to evaluate the probability of warrant exercises and the merit of including potential cash proceeds from the exercise of the warrants in our future liquidity projections.

Previous wording

Cash at June 30, 2025 totaled $7,966,500 as compared to $7,827,487 at December 31, 2024, an increase of $139,013. The following table shows Cardio’s cash flows from operating activities, investing activities and financing activities for the stated periods.

Current wording

Cash at September 30, 2025 totaled $6,355,218 as compared to $7,827,487 at December 31, 2024, a decrease of $1,472,269. The following table shows Cardio’s cash flows from operating activities, investing activities and financing activities for the stated periods.

Previous wording

Cash used in operating activities for the six months ended June 30, 2025 was $2,971,566 as compared to $2,443,450 for the six months ended June 30, 2024. The cash used in operations during the six months ended June 30, 2025 is a function of net loss of $3,318,263 adjusted for the following non-cash operating items: depreciation of $75,441, amortization of $139,022, $61,390 in stock-based compensation, a decrease of $5,685 in accounts receivable, a decrease of $220,762 in prepaid expenses and other current assets, a decrease of $38,937 in accounts payable and accrued expenses and a decrease in lease liability of $116,666.

Current wording

Cash used in operating activities for the nine months ended September 30, 2025 was $4,364,984 as compared to $3,600,809 for the nine months ended September 30, 2024. The cash used in operations during the nine months ended September 30, 2025 is a function of net loss of $5,032,799 adjusted for the following non-cash operating items: depreciation of $115,843, amortization of $188,208, $86,152 in stock-based compensation, a decrease of $7,391 in accounts receivable, a decrease of $383,650 in prepaid expenses and other current assets, an increase of $63,073 in accounts payable and accrued expenses and a decrease in lease liability of $176,502.

Previous wording

The cash used in operations during the six months ended June 30, 2024 is a function of net loss of $5,451,579 adjusted for the following non-cash operating items: depreciation of $39,579, amortization of $69,877, $2,546,135 in stock-based compensation, an increase of $2,560 in accounts receivable, a decrease of $656,310 in prepaid expenses and other current assets, a decrease of $191,132 in accounts payable and accrued expenses and a decrease in lease liability of $110,080.

Current wording

The cash used in operations during the nine months ended September 30, 2024 is a function of net loss of $6,864,145 adjusted for the following non-cash operating items: depreciation of $76,341, amortization of $115,632, $2,568,753 in stock-based compensation, an increase of $9,140 in accounts receivable, a decrease of $846,715 in prepaid expenses and other current assets, a decrease of $168,405 in accounts payable and accrued expenses and a decrease in lease liability of $166,560.

Previous wording

Cash used in investing activities for the six months ended June 30, 2025 was $83,132 compared to $271,010 for the six months ended June 30, 2024. The cash used in investing activities for the six months ended June 30, 2025 and 2024 was due to purchases of property and equipment and patent costs incurred.

Current wording

Cash used in investing activities for the nine months ended September 30, 2025 was $340,951 compared to $349,577 for the nine months ended September 30, 2024. The cash used in investing activities for the nine months ended September 30, 2025 and 2024 was due to purchases of property and equipment and patent costs incurred.

Previous wording

Cash provided by financing activities for the six months ended June 30, 2025 was $3,193,711 as compared to $2,741,056 for the six months ended June 30, 2024. Cash provided by financing activities for the six months ended June 30, 2025 was due to $3,423,784 in net proceeds from the sale of common stock offset by $230,073 in payments of finance agreement. Cash provided by financing activities for the six months ended June 30, 2024 was due to $3,021,556 in net proceeds from the sale of common stock and warrants offset by $280,500 in payments pursuant to a finance agreement.

Current wording

Cash provided by financing activities for the nine months ended September 30, 2025 was $3,233,666 as compared to $4,649,453 for the nine months ended September 30, 2024. Cash provided by financing activities for the nine months ended September 30, 2025 was due to $3,540,430 in net proceeds from the sale of common stock offset by $306,764 in payments of finance agreement. Cash provided by financing activities for the nine months ended September 30, 2024 was due to $5,023,453 in net proceeds from the sale of common stock and warrants offset by $374,000 in payments pursuant to a finance agreement.

Previous wording

The Company has a worldwide exclusive license agreement with the University of Iowa Research Foundation (UIRF) relating to its patent and patent-pending technology (the “Exclusive License Agreement”). Under the terms of the Exclusive License Agreement, the Company will have to pay each of: (1) 1% of either the: (i) aggregate consideration (and trailing consideration, if any) for a liquidation event; or (ii) pre-money valuation for an initial public offering, (the “Equity Rights”) (2) 2% of annual net sales, and (3) 15% of non-royalty fees paid to licensee if it enters into one or more sublicensing agreements. Upon the Closing of the Business Combination, the Company issued 3,639 (109,170 prior to the Reverse Stock Split) Shares of Common Stock to UIRF in accordance with the Equity Rights under the Exclusive License Agreement. The Company has had minimal sales of $62,221 to date and has paid 2% or approximately $1,300 in total royalty fees to UIRF under the exclusive license.

Current wording

The Company has a worldwide exclusive license agreement with the University of Iowa Research Foundation (UIRF) relating to its patent and patent-pending technology (the “Exclusive License Agreement”). Under the terms of the Exclusive License Agreement, the Company will have to pay each of: (1) 1% of either the: (i) aggregate consideration (and trailing consideration, if any) for a liquidation event; or (ii) pre-money valuation for an initial public offering, (the “Equity Rights”) (2) 2% of annual net sales, and (3) 15% of non-royalty fees paid to licensee if it enters into one or more sublicensing agreements. Upon the Closing of the Business Combination, the Company issued 3,639 (109,170 prior to the Reverse Stock Split) Shares of Common Stock to UIRF in accordance with the Equity Rights under the Exclusive License Agreement. The Company has had minimal sales of $65,076 to date and has paid 2% or approximately $1,300 in total royalty fees to UIRF under the exclusive license.

Previous wording

Our senior management has reviewed the critical accounting policies and estimates with the Audit Committee of our Board of Directors. For a description of the Company’s critical accounting policies and estimates, refer to “Part II—Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates” in our most recent Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 20, 2025. Critical accounting policies are those that are most important to the portrayal of our financial condition, results of operations and cash flows and require management’s most difficult, subjective and complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. If actual results were to differ significantly from estimates made, the reported results could be materially affected. There were no significant changes to our critical accounting policies and estimates during the three and six months ended June 30, 2025.

Current wording

Our senior management has reviewed the critical accounting policies and estimates with the Audit Committee of our Board of Directors. For a description of the Company’s critical accounting policies and estimates, refer to “Part II—Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates” in our most recent Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 20, 2025. Critical accounting policies are those that are most important to the portrayal of our financial condition, results of operations and cash flows and require management’s most difficult, subjective and complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. If actual results were to differ significantly from estimates made, the reported results could be materially affected. There were no significant changes to our critical accounting policies and estimates during the three and nine months ended September 30, 2025.