BCDA

Risks Related to Development and Commercialization ● Our success depends in large part on our ability to obtain approval for, and successfully commercialize, the CardiAMP Cell Therapy System ● Because the CardiAMP Cell Therapy System is, to our knowledge, the first cardiac cell-based therapy with an accepted pivotal trial that is to be regulated by the FDA via the premarket approval pathway, the approval process for the CardiAMP Cell Therapy System is uncertain. ● Our autologous and allogeneic therapies, delivery systems and other therapeutic candidates are based on novel technology, which makes it difficult to accurately and reliably predict the time and cost of product development and subsequently obtaining regulatory approval.
Risks Relating to Government Regulation, Compliance and Litigation ● Even if we obtain regulatory approval for a product candidate, including our autologous CardiAMP Cell Therapy System, CardiALLO allogeneic MSC therapy and other therapeutic candidates, these products or therapies, along with our other regulated products, will be subject to ongoing regulatory scrutiny. ● We may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory agencies. ● If we fail to obtain and maintain necessary regulatory clearances or approvals for our therapeutic candidates or products, or if clearances or approvals for our therapeutic candidates or products in additional indications are delayed or not issued, our commercial operations would be harmed. ● Serious adverse events or other safety risks could require us to abandon development and preclude, delay or limit approval of our therapeutic candidates or products or limit the scope of any approved indication or market acceptance. ● Our therapeutic candidates are intended to treat patients who are extremely ill, and patient deaths that occur in our clinical trials could negatively impact our business even if they are not shown to be related to our therapeutic candidates. ● If we or our suppliers fail to comply with the FDA’s QMSR, our manufacturing operations could be delayed or shut down and product sales could suffer. ● The requirements to obtain regulatory approval of the FDA and regulators in other jurisdictions can be costly, time-consuming, and unpredictable.
Risks Related to Our Securities ● Our failure to meet the continued listing requirements of the Nasdaq could result in a de-listing of our common stock. ● We may be exposed to additional risks as a result of our reverse merger transaction. ● Our annual and quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline. ● Raising additional funds through debt or equity financing could be highly dilutive and may cause the market price of our common stock to decline. ● Future sales and issuances of our common stock or rights to purchase our common stock, including pursuant to the HCW Sales Agreement or under our equity incentive plans, could result in additional dilution of the percentage ownership of our existing stockholders and could cause our stock price to fall.
Our net loss for the year ended December 31, 2025 was $8.2 million and our accumulated deficit totaled $168.3 million as of December 31, 2025.
Our audited consolidated financial statements as of and for the year ended December 31, 2025 have been prepared on the basis that we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business.
Absent additional funding, management believes our cash and cash equivalents of approximately $2.5 million as of December 31, 2025 are not sufficient to fund our planned expenditures and meet our obligations beyond May 2026.
For example, in September 2025, we completed the Registered Offering, pursuant to which we issued 4,800,000 shares of common stock, including the shares issued upon the exercise of pre-funded warrants, and common warrants to purchase 4,800,000 shares of common stock.
We are also limited in the amount we may sell under the HCW Sales Agreement to the amount that is covered by an effective registration statement with the Securities and Exchange Commission (SEC), the amount of which was approximately $5.1 million as of March 24, 2026.
We are subject to income and other taxes in the United States.
For example, the U.S. government recently enacted significant tax reform, and certain provisions of this new law may adversely affect us.
The legislation is unclear in many respects and could be subject to potential amendments and technical corrections and will be subject to interpretations and implementing regulations by the U.S.
Treasury and Internal Revenue Service, any of which could mitigate or increase certain adverse effects of the legislation.
Our reliance on third-party vendors subjects us to a number of risks that could impact our ability to manufacture our products and therapeutic candidates and harm our business, including: • interruption of supply resulting from modifications to, or discontinuation of, a supplier’s operations; • delays in product shipments resulting from uncorrected defects, reliability issues or a supplier’s failure to consistently produce quality components; • price fluctuations due to a lack of long-term supply arrangements with our suppliers for key components; • price fluctuations due to the threat or imposition of certain tariffs, which may increase costs for our suppliers; • inability to obtain adequate supply in a timely manner or on commercially reasonable terms; • difficulty identifying and qualifying alternative suppliers for components in a timely manner; • inability of the manufacturer or supplier to comply with Quality Management System Regulations, or QMSR, enforced by the FDA and state regulatory authorities; • inability to control the quality of products manufactured by third parties; • production delays related to the evaluation and testing of products from alternative suppliers and corresponding regulatory qualifications; and • delays in delivery by our suppliers due to changes in demand from us or their other customers.
Such production delays or shortfalls may be caused by many factors, including the following: • we intend to significantly expand our manufacturing capacity, and our production processes may have to change to accommodate this growth; • key components and sub-assemblies of our products and therapeutic candidates are currently provided by a single supplier or limited number of suppliers, and we do not maintain large inventory levels of these components and sub-assemblies; if we experience a shortage in any of these components or sub-assemblies, we will need to identify and qualify new supply sources, which could increase our expenses and result in manufacturing delays; • we may experience a delay in completing validation and verification testing for new controlled-environment rooms at our manufacturing facilities; • we have limited experience in complying with FDA’s QMSR, which applies to the manufacture of our products and therapeutic candidates; and • to increase our manufacturing output significantly, we will have to attract and retain qualified employees, who are in short supply, for our manufacturing operations.
In addition, product manufacturers and their facilities are subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatory authorities for compliance with good manufacturing practices or QMSR, and adherence to commitments made in the applicable regulatory approval.
If we or our suppliers fail to comply with the FDA ’ s QMSR, our manufacturing operations could be delayed or shut down and product sales could suffer.
Our manufacturing processes and those of our third-party suppliers are required to comply with the FDA’s QMSR, which covers the procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping.
We are subject to unannounced inspections by the FDA and the Food and Drug Branch of CDHS to determine our compliance with the QMSR and other regulations, and these inspections may include the manufacturing facilities of our suppliers.
As of March 24, 2026, our executive officers, directors, 5% stockholders and their affiliates beneficially owned approximately 25.8% of our voting stock.
As of March 24, 2026, we had up to approximately $5.1 million of our common stock available for offer and sale under the prospectus supplement.

Gone since FY2024

Risks Related to Development and Commercialization ● Our success depends in large part on our ability to obtain approval for, and successfully commercialize, the CardiAMP Cell Therapy System.
Because the CardiAMP Cell Therapy System is, to our knowledge, the first cardiac cell-based therapy with an accepted pivotal trial that is to be regulated by the FDA via the premarket approval pathway, the approval process for the CardiAMP Cell Therapy System is uncertain. ● Our cell therapy systems and other therapeutic candidates are based on novel technology, which makes it difficult to accurately and reliably predict the time and cost of product development and subsequently obtaining regulatory approval.
Risks Relating to Government Regulation, Compliance and Litigation ● Even if we obtain regulatory approval for a product candidate, including our cell therapy systems and other therapeutic candidates, these products or therapies, along with our other regulated products, will be subject to ongoing regulatory scrutiny. ● We may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory agencies. ● If we fail to obtain and maintain necessary regulatory clearances or approvals for our therapeutic candidates or products, or if clearances or approvals for our therapeutic candidates or products in additional indications are delayed or not issued, our commercial operations would be harmed. ● Serious adverse events or other safety risks could require us to abandon development and preclude, delay or limit approval of our therapeutic candidates or products or limit the scope of any approved indication or market acceptance. ● Our therapeutic candidates are intended to treat patients who are extremely ill, and patient deaths that occur in our clinical trials could negatively impact our business even if they are not shown to be related to our therapeutic candidates. ● If we or our suppliers fail to comply with the FDA’s QSRs, or QMSR, when it goes into effect in 2026, our manufacturing operations could be delayed or shut down and product sales could suffer. ● The requirements to obtain regulatory approval of the FDA and regulators in other jurisdictions can be costly, time-consuming, and unpredictable.
Risks Related to Our Securities ● Our failure to meet the continued listing requirements of the Nasdaq could result in a de-listing of our common stock. ● We may be exposed to additional risks as a result of our reverse merger transaction. ● Our annual and quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline. ● Raising additional funds through debt or equity financing could be dilutive and may cause the market price of our common stock to decline. ● Future sales and issuances of our common stock or rights to purchase our common stock, including pursuant to the HCW Sales Agreement or under our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
Our net loss for the year ended December 31, 2024 was $7.9 million and our accumulated deficit totaled $160.1 million as of December 31, 2024.
Our audited consolidated financial statements as of and for the year ended December 31, 2024 have been prepared on the basis that we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business.
Absent additional funding, management believes our cash and cash equivalents of approximately $2.4 million as of December 31, 2024 are not sufficient to fund our planned expenditures and meet our obligations beyond May 2025.
For example, in September 2024, we completed the Registered Offering, pursuant to which we issued 2,400,000 shares of common stock, including the shares issued upon the exercise of pre-funded warrants, and common warrants to purchase 2,400,000 shares of common stock.
We are also limited in the amount we may sell under the HCW Sales Agreement to the amount that is covered by an effective registration statement with the Securities and Exchange Commission (SEC), the current amount of which is approximately $1.1 million.
We are subject to income and other taxes in the U.S.
For example, the U.S. government recently enacted significant tax reform, and certain provisions of the new law may adversely affect us.
For example, beginning in 2022, the legislation commonly known as the Tax Cuts and Jobs Act of 2017 eliminated the option to deduct research and development expenditures currently and requires taxpayers to capitalize and amortize them over five or fifteen years pursuant to Section 174 of the Code.
If the requirement to capitalize Section 174 expenditures is not modified, it may impact our effective tax rate and our cash tax liability in future years.
The legislation is unclear in many respects and could be subject to potential amendments and technical corrections and will be subject to interpretations and implementing regulations by the Treasury and Internal Revenue Service, any of which could mitigate or increase certain adverse effects of the legislation.
Changes with respect to the transition to a territorial tax system are generally expected to have little impact given our lack of foreign operations.
Our reliance on third-party vendors subjects us to a number of risks that could impact our ability to manufacture our products and therapeutic candidates and harm our business, including: • interruption of supply resulting from modifications to, or discontinuation of, a supplier’s operations; • delays in product shipments resulting from uncorrected defects, reliability issues or a supplier’s failure to consistently produce quality components; • price fluctuations due to a lack of long-term supply arrangements with our suppliers for key components; • price fluctuations due to the threat or imposition of certain tariffs, which may increase costs for our suppliers; • inability to obtain adequate supply in a timely manner or on commercially reasonable terms; • difficulty identifying and qualifying alternative suppliers for components in a timely manner; • inability of the manufacturer or supplier to comply with Quality System Regulations, or QSRs, enforced by the FDA and state regulatory authorities; • inability to control the quality of products manufactured by third parties; • production delays related to the evaluation and testing of products from alternative suppliers and corresponding regulatory qualifications; and • delays in delivery by our suppliers due to changes in demand from us or their other customers.
Such production delays or shortfalls may be caused by many factors, including the following: • we intend to significantly expand our manufacturing capacity, and our production processes may have to change to accommodate this growth; • key components and sub-assemblies of our products and therapeutic candidates are currently provided by a single supplier or limited number of suppliers, and we do not maintain large inventory levels of these components and sub-assemblies; if we experience a shortage in any of these components or sub-assemblies, we will need to identify and qualify new supply sources, which could increase our expenses and result in manufacturing delays; • we may experience a delay in completing validation and verification testing for new controlled-environment rooms at our manufacturing facilities; • we have limited experience in complying with FDA’s QSRs, which applies to the manufacture of our products and therapeutic candidates; and • to increase our manufacturing output significantly, we will have to attract and retain qualified employees, who are in short supply, for our manufacturing operations.
In addition, product manufacturers and their facilities are subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatory authorities for compliance with good manufacturing practices or QSRs and adherence to commitments made in the applicable regulatory approval.
If we or our suppliers fail to comply with the FDA ’ s QSRs, or QMSR when it goes into effect, our manufacturing operations could be delayed or shut down and product sales could suffer.
Our manufacturing processes and those of our third-party suppliers are required to comply with the FDA’s QSRs, which covers the procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping.
Further, the FDA issued a final rule replacing the QSR with QMSR, which goes into effect in February 2026.
We are subject to unannounced inspections by the FDA and the Food and Drug Branch of CDHS to determine our compliance with the QSR, or QMSR, and other regulations, and these inspections may include the manufacturing facilities of our suppliers.
As of March 26, 2025, our executive officers, directors, 5% stockholders and their affiliates beneficially owned approximately 17.0% of our voting stock.
As of March 26, 2025, we had up to $1.1 million of our common stock available for offer and sale under the prospectus supplement.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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