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Cardio Diagnostics Holdings, Inc.

For the period ended Jun 30, 2026. Filed Aug 7, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2026 · Filed Aug 7, 2026

CDIO$1.65-1.4%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-03-31; filed 2026-05-15.

0001553350-26-000089

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-06-30; filed 2026-08-07.

0001079973-26-001016

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 87 previous paragraphs and 100 current paragraphs.

61 unchanged; 20 reworded; 17 added; 6 removed; 0 previous and 2 current paragraphs rearranged.

Tables are not compared: 8 previous and 9 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (17)

Current report

By leveraging our AI-driven Multi-Omics Engine, Cardio developed and launched two physician-prescribed blood tests, which included conducting rigorous studies and validation. The first test, Epi+Gen CHD™, can predict a patient’s risk for having a CHD event, including a heart attack. The second test, PrecisionCHD™, can detect molecular signals associated with the presence of coronary heart disease. The PrecisionCHD™ test is coupled to Actionable Clinical Intelligence (“ACI”), a platform that offers epigenetic insights to clinicians prescribing the test to help personalize patient management. We believe that our Epi+Gen CHD™ and PrecisionCHD™ tests are categorized as laboratory-developed tests, or “LDTs.” Cardio is actively pursuing payer coverage and reimbursement for these tests, which would be necessary to significantly increase testing volume and revenue growth. Currently, we have secured reimbursement codes from the American Medical Association for both tests, 0439U for Epi+Gen CHD and 0440U for PrecisionCHD. We have also secured gapfill payment rates for both tests from the Centers of Medicare and Medicaid Services (CMS) of $854 per test for both tests. The Company is continuing its efforts related to payer coverage and reimbursement, including pursuing Medicare coverage and in the quarter ended June 30, 2026, the Company established the ability to submit out-of-network claims to commercial payers, secured its first coverage by Atlas Healthcare Physicians (AHP), a community-driven, independent physician association (IPA) based in Southern California. AHP started covering Cardio’s tests, Epi+Gen CHD™ and PrecisionCHD™, for their members with prior authorization in May 2026. AHP consists of an expansive network of primary care and specialists, hospitals, and ancillary providers serving managed care populations across Los Angeles and Orange County.

Current report

In parallel, Cardio’s go-to-market strategy is targeted towards segments and stakeholders that do not rely heavily on payer reimbursement. The majority of our current efforts include offering the tests via: 1) telemedicine for patients willing to pay for testing out-of-pocket, 2) smaller and more innovative provider practices such as functional medicine and concierge medicine practices, 3) employer organizations and unions that are interested in reducing costs and risks related to cardiovascular disease, and improving the health of their employee population, and 4) engaging benefit brokers and consultants to help identify employers invested in or looking to invest in cardiovascular disease prevention and early detection. Despite long partnership and sales cycles, in some instance as long as 24 months, Cardio has been able to increase the number of provider and other organizations offering its tests and has continued the development of a more robust sales and partnership pipeline. In the quarter ended June 30, 2026, Cardio increased the number of provider organizations offering our tests to their patients, increased engagement and re-engagement efforts of providers, and continued to showcase our products to employers, unions, and benefit brokers at leading conferences.

Current report

In addition to our blood tests, we launched HeartRisk™, a cardiovascular disease risk intelligence platform. This platform provides population level, de-identified, aggregated and compliant data to stakeholders such as employers and benefit brokers, to help inform their benefit design strategies to mitigate costs and risks associated with cardiovascular disease. We also have a research-use-only (“RUO”) solution, CardioInnovate360™, that leverages our AI-driven Multi-Omics Engine to support the discovery, development and validation of novel biopharmaceuticals for the assessment and management of cardiovascular diseases.

Current report

To further diversify our go-to-market strategy, the Company continues to explore new market opportunities in the US and internationally. The first such market outside of the US is India via an agreement entered into with Aimil Ltd. and Dr. LalPathLabs, that was announced in early 2026. In the quarter ended June 30, 2026, the Company made progress in its implementation in India with initial shipment of Company proprietary reagents to Aimil Ltd and Dr. Lal Path Labs. The Company is also engaged in discussions related to other potential international expansions.

Current report

On July 22, 2026, the SEC adopted a final rule implementing a proposed revision to Nasdaq’s requirements for continued listing on Nasdaq. The rule, implemented through Nasdaq Rules 5450(a)(3) and 5550(a)(6), would require Nasdaq-listed companies to maintain at least $5 million in market value of listed securities (“MVLS”), with an immediate suspension and delisting framework if the requirement is not met for 30 consecutive business days. Unlike most Nasdaq listing standards, the rule provides for no cure period and very limited appeal rights. On July 29, 2026, the SEC temporarily stayed the July 22 order after receiving multiple notices of intention to petition review of the delegated action from parties that would likely be impacted by the new rule. The stay will remain in effect until further order of the SEC. The Company is closely monitoring its MVLS and preparing for next steps, should they become necessary. If our securities are delisted from Nasdaq for failure to meeting the continuing MVLS listing standard, our securities will trade on the OTC market and we anticipate that raising needed capital will become more difficult.

Current report

Comparisons for the six months ended June 30, 2026 and 2025:

Current report

Cardio’s net loss for the six months ended June 30, 2026 was $3,289,626 as compared to $3,318,263 for the six months ended June 30, 2025, a decrease of $28,637. The decrease in net loss was primarily the result of a decrease in amortization expense.

Current report

Cardio had $5,360 and $7,475 in revenue for the three months ended June 30, 2026 and 2025, 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 report

Cardio had $8,040 and $8,415 in revenue for the six months ended June 30, 2026 and 2025, respectively.

Current report

Expenses related to sales and marketing for the three months ended June 30, 2026, were $190,183 as compared to $202,850 for the three months ended June 30, 2025, a decrease of $12,667. The overall decrease was due to a decrease in sales and marketing efforts in the second quarter of 2026.

Current report

Research and development expense for the three months ended June 30, 2026 was $162,929 as compared to $178,536 for the three months ended June 30, 2025, a decrease of $15,607 due to a decrease in lab processing.

Current report

General and administrative expenses for the three months ended June 30, 2026, were $1,144,802 as compared to $1,296,303 for the three months ended June 30, 2025, a decrease of $151,501. The overall decrease is primarily due to a decrease in legal and professional expense, consulting and contracting expense, and insurance expenses in 2026.

Current report

General and administrative expense for the three months ended June 30, 2026 included payroll and related costs of $354,712, rent and other facility costs of $93,727, legal and professional fees of $114,551, consulting and contractor fees of $111,534, insurance expense of $141,614, filing fees of $15,425, transfer agent fees of $6,115, software and web computing expenses of $145,584, board compensation of $49,351, and general corporate overhead expenses of $112,189.

Current report

General and administrative expense for the three months ended June 30, 2025 included payroll and related costs of $345,031, rent and other facility costs of $89,461, legal and professional fees of $209,744, consulting and contractor fees of $165,905, insurance expense of $158,263, filing fees of $22,159, transfer agent fees of $5,554, software and web computing expenses of $101,723, board compensation of $49,778, investor relations expense of $3,750, and general corporate overhead expenses of $144,935.

Current report

General and administrative expense for the six months ended June 30, 2026 included payroll and related costs of $708,667, rent and other facility costs of $179,284, legal and professional fees of $343,806, consulting and contractor fees of $256,369, insurance expense of $287,968, filing fees of $32,675, transfer agent fees of $16,225, software and web computing expenses of $235,609, board compensation of $99,084, investor relations expense of 38,092, franchise tax expense of $178,467 and general corporate overhead expenses of $224,053.

Current report

General and administrative expense for the six months ended June 30, 2025 included payroll and related costs of $690,528, rent and other facility costs of $155,854, legal and professional fees of $511,264, consulting and contractor fees of $326,707, insurance expense of $314,830, filing fees of $42,290, transfer agent fees of $11,936, software and web computing expenses of $180,314, board compensation of $99,390, investor relations expense of $7,500, franchise tax of $225, and general corporate overhead expenses of $233,766.
Removed paragraphs (6)

Previous report

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 report

On September 19, 2025, the FDA formally rescinded its May 2024 final rule regulating Laboratory Developed Tests (LDTs) as medical devices, following a March 31, 2025, federal court ruling. The U.S. District Court for the Eastern District of Texas found the FDA exceeded its authority, reverting LDT oversight to Clinical Laboratory Improvement Amendments (CLIA). There has been no further pursuit by the current administration.

Previous report

Cardio had $2,680 and $940 in revenue for the three months ended March 31, 2026 and 2025, respectively. The increase in revenue is a result of new providers onboarding and additional usage of our tests by current provider and employer clients. Additional providers and organizations are continuing to be onboarded. However, there is a one to three quarter period from onboarding to ramping up usage of tests.

Previous report

General and Administrative expense for the three months ended March 31, 2026 included payroll and related costs of $353,955, rent and other facility costs of $85,557, legal and professional fees of $229,255, consulting and contractor fees of $144,835, insurance expense of $146,354, filing fees of $17,250, transfer agent fees of $10,110, software and web computing expenses of $90,025, board compensation of $49,733, investor relations expense of $38,092, franchise tax of $178,467 and general corporate overhead expenses of $111,864.

Previous report

General and Administrative expense for the three months ended March 31, 2025 included payroll and related costs of $345,497 (including stock compensation expenses of $30,612), rent and other facility costs of $66,393, legal and professional fees of $301,520, consulting and contractor fees of $160,802, insurance expense of $156,567, filing fees of $20,131, transfer agent fees of $6,382, software and web computing expenses of $78,591, board compensation of $49,612, investor relations expense of $3,750, franchise tax of $225 and general corporate overhead expenses of $88,831.
Reworded paragraphs (20)

Previous wording

The following discussion and analysis provide information that Cardio’s management believes is relevant to an assessment and understanding of Cardio’s results of operations and financial condition. You should read the following discussion and analysis of Cardio’s results of operations and financial condition together with its unaudited condensed consolidated financial statements and related notes to those statements included elsewhere in this Quarterly Report on Form 10-Q, and its audited consolidated financial statements and related notes to those statements included in the Company’s 2025 Annual Report on Form 10-K that was filed on March 13, 2026 (the “2025 Form 10-K”). In addition to historical financial information, this discussion contains forward-looking statements based upon Cardio’s current expectations that involve risks and uncertainties, including those described in the section titled, “Special Note About Forward-Looking Statements,” above. Cardio’s actual results could differ materially from such forward-looking statements as a result of various factors, including those set forth under “Risk Factors” in the 2025 Form 10-K (Item 1A therein). Our historical results are not necessarily indicative of the results that may be expected for any period in the future.

Current wording

The following discussion and analysis provide information that Cardio’s management believes is relevant to an assessment and understanding of Cardio’s results of operations and financial condition. You should read the following discussion and analysis of Cardio’s results of operations and financial condition together with its unaudited condensed consolidated financial statements and related notes to those statements included elsewhere in this Quarterly Report on Form 10-Q, and its audited consolidated financial statements and related notes to those statements included in the Company’s 2025 Annual Report on Form 10-K that was filed on March 13, 2026 (the “2025 Form 10-K”). In addition to historical financial information, this discussion contains forward-looking statements based upon Cardio’s current expectations that involve risks and uncertainties, including those described in the section titled, “Special Note About Forward-Looking Statements,” above. Cardio’s actual results could differ materially from such forward-looking statements as a result of various factors, including those set forth under “Risk Factors” in the 2025 Form 10-K (Item 1A therein), as well as in Item 1A of Part II of this Quarterly Report on Form 10-Q. Our historical results are not necessarily indicative of the results that may be expected for any period in the future.

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 PrecisionCHD™ tests is 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 24 months, Cardio has been able to increase the number of provider and other organizations offering its tests and has continued the development of a more robust sales and partnership pipeline. In the quarter ended March 31, 2026, the focus of the Company remained in driving adoption of our clinical solutions, predominantly among providers, channel partners, and employers. The Company also completed the scheduled Heart Health Fairs at YMCA of East Tennessee and Southdale YMCA. In addition, the Company has made progress in its implementation in India in partnership with Aimil Ltd and Dr. Lal Path Labs, and in discussions related to other potential international expansions. Finally, the setup of the Company’s new high complexity CLIA lab was completed with the initial CLIA survey conducted by a CLIA compliance manager and found no deficiencies. In addition to the federal certification requirements, the laboratory also received its out-of-state licenses from California, Maryland, Pennsylvania, and Rhode Island. Testing of patient samples have commenced at this facility for samples…

Excerpt shortened here; the source contains the full paragraph.

Current wording

Finally, the Company completed the setup of its new high complexity CLIA lab with the initial CLIA survey conducted by a CLIA compliance manager and found no deficiencies. In addition to the federal certification requirements, the laboratory also received its out-of-state licenses from California, Maryland, Pennsylvania, and Rhode Island. Testing of patient samples has commenced at this facility for samples originating from all states except New York, pending the acquisition of a New York license. As a result of the lab setup, the Company is no longer reliant on a third-party lab for patient sample processing, and the lab setup provides an opportunity to reduce cost of goods sold with scale. In the quarter ended June 30, 2026, the Company made progress in its New York license application.

Previous wording

Cardio’s net loss for the three months ended March 31, 2026 was $1,788,158 as compared to $1,635,064 for the three months ended March 31, 2025, an increase of $153,094. The increase in net loss was primarily the result of an increase in General and Administrative expenses mostly related to annual franchise taxes.

Current wording

Cardio’s net loss for the three months ended June 30, 2026 was $1,501,468 as compared to $1,683,199 for the three months ended June 30, 2025, a decrease of $181,731. The decrease in net loss was primarily the result of a decrease in R&D, Selling, General and Administrative expenses in 2026.

Previous wording

Expenses related to sales and marketing for the three months ended March 31, 2026, were $196,712 as compared to $188,977 for the three months ended March 31, 2025, an increase of $7,735. The overall increase was due to an increase in sales and marketing personnel and efforts in the first quarter of 2026. We expect our sales and marketing costs to increase with the ongoing implementation in India.

Current wording

Expenses related to sales and marketing for the six months ended June 30, 2026, were $386,895 as compared to $391,827 for the six months ended June 30, 2025, a decrease of $4,932. The overall decrease was due to a decrease in sales and marketing efforts in the second quarter of 2026. We expect our sales and marketing costs to increase with the ongoing implementation in India.

Previous wording

Research and development expense for the three months ended March 31, 2026 was $129,776 as compared to $118,784 for the three months ended March 31, 2025, an increase of $10,992. The overall increase was due to an increase in research and development personnel in 2026. We expect our research and development costs to increase with ongoing and planned studies to generate additional clinical and economic evidence, and to support reimbursement conversations with payers.

Current wording

Research and development expense for the six months ended June 30, 2026 was $292,705 as compared to $297,320 for the six months ended June 30, 2025, a slight decrease of $4,615. The overall decrease was due to a decrease in lab processing offset by the increase in research and development personnel in the second quarter of 2026. We expect our research and development costs to increase with ongoing and planned studies to generate additional clinical and economic evidence, and to support reimbursement conversations with payers.

Previous wording

General and administrative expenses for the three months ended March 31, 2026, were $1,455,497 as compared to $1,278,301 for the three months ended March 31, 2025, an increase of $177,196. The overall increase is primarily due to an increase in software and web computing fees, investor relations expense, annual franchise taxes expenses and corporate overhead expenses in 2026.

Current wording

General and administrative expenses for the six months ended June 30, 2026, were $2,600,299 as compared to $2,574,604 for the six months ended June 30, 2025, an increase of $25,695. The overall increase is primarily due to an increase in rent and facility expenses, software and web computing fees, investor relations expense, and annual franchise taxes expenses, offset by a decrease in legal and professional expense, consulting and contracting expense, and insurance expenses in 2026.

Previous wording

We expect our general corporate overhead to remain relatively flat. However, 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, and costs associated with securing a new office lease. 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

Patents are amortized over their estimated useful lives of approximately 14 and 15 years, respectively. Amortization expense related to patents charged to operations was $5,532 and $41,438 for the three months ended March 31, 2026 and 2025, respectively. The amortization for the three months ended March 31, 2025 also included $4,000 amortization for intangible assets, which has been fully amortized during 2025.

Current wording

Patents are amortized over their estimated useful lives of approximately 14 and 15 years, respectively. Amortization expense related to patents charged to operations was $5,593 and $7,152 for the three months ended June 30, 2026 and 2025, respectively and $11,125 and $48,590 for the six months ended June 30, 2026 and 2025, respectively. The amortization for the three and six months ended June 30, 2025 also included $1,333 and $5,333 respectively amortization for intangible assets, which has been fully amortized during 2025.

Previous wording

Total other expense for the three months ended March 31, 2026, was $(3,321) as compared to $(4,504) for the three months ended March 31, 2025. The total other expenses for the three months ended March 31, 2026, consists of interest expense of $3,439, net of interest income of $118. The total other expenses for the three months ended March 31, 2025, consists of interest expense of $4,691, net of interest income of $187.

Current wording

Total other expense for the three months ended June 30, 2026, was $(3,321) as compared to $(4,500) for the three months ended June 30, 2025. The total other expense for the three months ended June 30, 2026, consists of interest expense of $3,440, net of interest income of $119. 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.

Previous wording

On January 26, 2024, we entered into the Sales Agreement with Craig-Hallum. Pursuant to the Sales Agreement, we may sell, at our option, shares of our Common Stock through Craig-Hallum, as sales agent. Sales of our Common Stock were made pursuant to the Sales Agreement initially up to an aggregate of $17 million under the Initial Registration Statement and will be made pursuant to the Sales Agreement up to an aggregate of $9,476,508 under the Additional Registration Statement.

Current wording

On January 26, 2024, we entered into the Sales Agreement with Craig-Hallum. Pursuant to the Sales Agreement, we may sell, at our option, shares of our Common Stock through Craig-Hallum, as sales agent. Sales of our Common Stock were made pursuant to the Sales Agreement initially up to an aggregate of $17 million under a shelf registration statement declared effective in February 2024 (File No. 333-276725) and will continue to be made pursuant to the Sales Agreement up to an aggregate of $9,476,508 under a second shelf registration statement declared effective in February 2025 (File No. 333-284775).

Previous 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.

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 by way of a post-effective amendment.

Previous wording

We have had, and expect that we will continue to have, an ongoing need to raise additional cash from outside sources to fund our operations and grow our business, given the nominal amount of revenue we have generated since inception, coupled with substantial expenses both for ongoing business operations and to fund expenses incurred as a public company. We expect that our primary cash needs for the remainder of 2026 and for the foreseeable future will be for funding day-to-day operations and working capital requirements, funding our growth strategy, paying the setup expenses of our internal laboratory and paying expenses incurred in connection with our ongoing FDA submission activities. We explore our financing options on an ongoing basis. However, given recent stock prices and the extreme volatility of our stock, it continues to be challenging to balance cash that could be raised and the dilution that might be required to close a particular transaction. We expect that for the remainder of 2026, we will rely primarily on the ongoing ATM Offering, provided that market conditions are favorable.

Current wording

We have had, and expect that we will continue to have, an ongoing need to raise additional cash from outside sources to fund our operations and grow our business, given the nominal amount of revenue we have generated since inception, coupled with substantial expenses both for ongoing business operations and to fund expenses incurred as a public company. We expect that our primary cash needs for the remainder of 2026 and for the foreseeable future will be for funding day-to-day operations and working capital requirements, funding our growth strategy and paying expenses incurred in connection with our ongoing FDA submission activities. We explore our financing options on an ongoing basis. However, given recent stock prices and the extreme volatility of our stock, it continues to be challenging to balance cash that could be raised and the dilution that might be required to close a particular transaction. We expect that for the remainder of 2026, we will rely primarily on the ongoing ATM Offering, provided that market conditions are favorable. If our securities are delisted from Nasdaq, raising capital through the sale of securities, by way of the ATM Offering or otherwise, will become much more challenging going forward.

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 $1.68 on May 14, 2026. 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 $1.66 on August 6, 2026. 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. It is unlikely 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 March 31, 2026 totaled $7,077,021 as compared to $5,110,630 at December 31, 2025, an increase of $1,966,391. The following table shows Cardio’s cash flows from operating activities, investing activities and financing activities for the stated periods.

Current wording

Cash at June 30, 2026 totaled $5,586,697 as compared to $5,110,630 at December 31, 2025, an increase of $476,067. 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 three months ended March 31, 2026 was $1,562,212 as compared to $1,400,101 for the three months ended March 31, 2025. The cash used in operations during the three months ended March 31, 2026 is a function of net loss of $1,788,158 adjusted for the following non-cash operating items: depreciation of $44,240, amortization of $50,412, $24,733 in stock-based compensation, a decrease of $3,852 in accounts receivable, a decrease of $138,627 in prepaid expenses and other current assets, an increase of $25,528 in accounts payable and accrued expenses and a decrease in lease liability of $61,446.

Current wording

Cash used in operating activities for the six months ended June 30, 2026 was $2,904,576 as compared to $2,971,566 for the six months ended June 30, 2025. The cash used in operations during the six months ended June 30, 2026 is a function of net loss of $3,289,626 adjusted for the following non-cash operating items: depreciation of $88,523, amortization of $101,570, $49,085 in stock-based compensation, a decrease of $4,221 in accounts receivable, a decrease of $232,590 in prepaid expenses and other current assets, an increase of $32,640 in accounts payable and accrued expenses and a decrease in lease liability of $123,579.

Previous wording

The cash used in operations during the three months ended March 31, 2025 is a function of net loss of $1,635,064 adjusted for the following non-cash operating items: depreciation of $37,656, amortization of $87,664, $30,612 in stock-based compensation, a decrease of $9,060 in accounts receivable, a decrease of $107,461 in prepaid expenses and other current assets, an increase of $20,520 in accounts payable and accrued expenses and a decrease in lease liability of $58,010.

Current wording

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.

Previous wording

Cash used in investing activities for the three months ended March 31, 2026 was $63,696 compared to $47,415 for the three months ended March 31, 2025. The cash used in investing activities for the three months ended March 31, 2026 and March 31, 2025 was due to purchases of property and equipment and patent costs incurred.

Current wording

Cash used in investing activities for the six months ended June 30, 2026 was $110,485 compared to $83,132 for the six months ended June 30, 2025. The cash used in investing activities for the six months ended June 30, 2026 and 2025 was due to purchases of property and equipment and patent costs incurred.

Previous wording

Cash provided by financing activities for the three months ended March 31, 2026 was $3,592,299 as compared to $3,308,748 for the three months ended March 31, 2025. Cash provided by financing activities for the three months ended March 31, 2026 was due to $3,693,470 in net proceeds from the sale of common stock offset by $101,171 in payments of finance agreement. Cash provided by financing activities for the three months ended March 31, 2025 was due to $3,423,784 in net proceeds from the sale of common stock offset by $115,036 in payments of finance agreement

Current wording

Cash provided by financing activities for the six months ended June 30, 2026 was $3,491,128 as compared to $3,193,711 for the six months ended June 30, 2025. Cash provided by financing activities for the six months ended June 30, 2026 was due to $3,693,470 in net proceeds from the sale of common stock offset by $202,342 in payments of finance agreement. 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.

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: (i) the 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 $71,311 to date and has paid 2% or approximately $1,400 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: (i) the 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 $76,671 to date and has paid 2% or approximately $1,780 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, 2025, which was filed with the SEC on March 13, 2026. 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 months ended March 31, 2026.

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, 2025, which was filed with the SEC on March 13, 2026. 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, 2026.
Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

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

Current report — wording carried from elsewhere

Total other expense for the six months ended June 30, 2026, was $(6,642) as compared to $(9,004) for the six months ended June 30, 2025. The total other expense for the six months ended June 30, 2026, consists of interest expense of $6,879, net of interest income of $237. 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.