BCDA 10-K & 10-Q changes, risk factors and insider trading

Specifically, the HCW ATM Offering is limited by the terms and conditions in the HCW Sales Agreement. Under the terms of the HCW Sales Agreement, the obligations of HCW are only to use reasonable efforts to sell shares of our common stock, but there is no actual obligation to sell or guarantee that we will be able to place any shares. 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 iswas approximately $1.1$5.1 million.million as of March 24, 2026. The amounts we sell under the HCW ATM Offering will not satisfy all of our funding needs and our receipt of any funds thereunder may not be received on a timely basis, even if we are able and choose to sell and issue all of our common stock otherwise issuable pursuant to the HCW Sales Agreement.

We are subject to income and other taxes in the U.S.United States. Changes in laws and policy relating to taxes or trade may have an adverse effect on our business, financial condition and results of operations. For example, the U.S. government recently enacted significant tax reform, and certain provisions of thethis 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 U.S. Treasury and Internal Revenue Service, any of which could mitigate or increase certain adverse effects of the legislation. In addition, it is unclear how these U.S. federal income tax changes will affect state and local taxation. Generally, future changes in applicable U.S. or foreign tax laws and regulations, or their interpretation and application could have an adverse effect on our business, financial conditions and results of operations. Changes with respect to the transition to a territorial tax system are generally expected to have little impact given our lack of foreign 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 QSRsQMSR, and adherence to commitments made in the applicable regulatory approval. If we or a regulatory agency discovers previously unknown problems with a product such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions relative to that product or the manufacturing facility, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.

If we or our suppliers fail to comply with the FDA’s QSRs, or QMSR when it goes into effect,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 QSRs,QMSR, which covers the procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping. We are also subject to similar state requirements and licenses. In addition, we must engage in extensive record keeping and reporting and must make available our manufacturing facilities and records for periodic unannounced inspections by governmental agencies, including the FDA, state authorities and comparable agencies in other countries. If we fail a Quality System inspection, our operations could be disrupted and our manufacturing interrupted. Further, the FDA issued a final rule replacing the QSR with QMSR, which goes into effect in February 2026. Failure to take adequate corrective action in response to an adverse Quality System inspection or failure to comply with applicable regulatory requirements could result in, among other things, a shut-down of our manufacturing operations, significant fines, suspension of marketing clearances and approvals, seizures or recalls, operating restrictions and criminal prosecutions, any of which would cause our business to suffer. Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with applicable regulatory requirements, which may result in manufacturing delays and cause our revenues to decline.

We have registered with the FDA as a medical device manufacturer and have obtained a manufacturing license from the California Department of Health Services, or CDHS. The FDA has broad post-market and regulatory enforcement powers. 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,QMSR and other regulations, and these inspections may include the manufacturing facilities of our suppliers. If the FDA or CDHS inspect our facility and discover compliance problems, we may have to shut down our facility and cease manufacturing until we can take the appropriate remedial steps to correct the audit findings. Taking corrective action may be expensive, time consumingtime-consuming and a distraction for management and if we experience a shutdown or delay at our manufacturing facility, we may be unable to produce our products, which may have an adverse impact on our business.

In the United States,HIPAAStates, HIPAA imposes limitations on the use and disclosure of an individual’s healthcare information by healthcare providers conducting certain electronic transactions, healthcare clearinghouses, and health insurance plans, collectively referred to as covered entities. Amendments to HIPAA by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) also impose compliance obligations and corresponding penalties for non-compliance on certain individuals and entities that provide services to or perform certain functions on behalf of healthcare providers and other covered entities involving the use or disclosure of individually identifiable health information, collectively referred to as business associates. HITECH also made significant increases in the penalties for improper use or disclosure of an individual’s health information under HIPAA and extended enforcement authority to state attorneys general. HIPAA also provides for notification requirements to federal regulators, and in some cases local and national media, for individuals whose health information has been inappropriately accessed or disclosed.

Furthermore, we have filed a prospectus supplement related to the offer and sale of our common stock under the HCW Sales Agreement. As of March 26,24, 2025,2026, we had up to $1.1approximately $5.1 million of our common stock available for offer and sale under the prospectus supplement. Any such HCW Sales Agreement sales would be made by HCW on a reasonable efforts basis. Any sales under the HCW Sales Agreement must be in compliance with the terms of such agreement and applicable law and the purchase price for such sales will fluctuate based on the price of our common stock. Depending on market liquidity at the time, sales of such shares may cause the trading price of our common stock to fall and any such issuances would be dilutive to our existing stockholders.

The CardiAMP Heart Failure Trial iswas a randomized, double-blinded, placebo procedure controlled, multi-center pivotal clinical trial for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF). The trial is assessingassessed the safety and effectiveness of the CardiAMP Cell Therapy System for the treatment of ischemic HFrEF, an investigational device system that has received Breakthrough Device Designation from the FDA. The CardiAMP autologous cell therapytherapy, is delivered during a standard minimally invasive catheter-based procedure. Patients are typically discharged after an overnight stay. The cell therapywhich is designed to promote microvascular repair through enhanced capillary density and reduced fibrosis, bothwas ofdelivered whichduring havea beenstandard demonstratedminimally ininvasive smallcatheter-based andprocedure. largePatients animalwere modelstypically ofdischarged disease.after an overnight stay.

The CardiAMP Cell Therapy Heart Failure II Trial is a Phase III, multi-center, randomized, double-blinded, sham-controlled study of up to 250 patients with NTproBNP levels >500 pg/ml at up to 40 centers in the United States. This confirmatory trial focuses on patients in active heart failure who demonstrated the greatest benefits in the interim results of the CardiAMP Heart Failure I Trial. In the interim results with 90% of the follow-up data available, this subgroup of patients showed strong signals of benefit, with 86% relative risk reduction in mortality and the primary outcome measure approaching statistical significance at two years.

In August 2024, theThe FDA approved a protocol amendment for the this trial, which allows patients who would have previously been excluded from treatment to receive additional cell deliveries to achieve the same target minimum dosage utilizing a treatment plan informed by the preprocedural CardiAMP Cell Population Analysis (CPA). The CPA approach was developed to select patients most likely to respond to therapy based on their therapeutic cell composition at screening. Utilizing available clinical results allowed us to refine the algorithm in the CardiAMP Heart Failure II Trial and develop a personalized treatment plan for patients below the CPA acceptance criteria. Such treatment plans adjust the number of dosing aliquots for patients with lower concentrations of important specified cells. Combined, the algorithm modifications and development of the treatment plan approach are expected to increase the number of patients eligible for the trial. Four clinical sites have been activated, and enrollment is ongoing in the trial.

The CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial is a Phase III, multi-center, randomized, double-blinded, placebo-controlled study of up to 343 patients at up to 40 clinical sites. The Phase III pivotal trial is designed to provide the primary support for the safety and efficacy of the CardiAMP Cell Therapy System for patients with no option chronic myocardial ischemia with refractory angina (BCDA-02). These patients experience frequent angina (i.e., chest pain) attacks that are uncontrolled by optimal drug therapy, and these patients are not suitable candidates for stent placement or bypass surgery, leaving them few therapeutic options. Our therapeutic approach uses many of the same novel aspects used in the CardiAMP Heart Failure Trial and is expected to leverage our experience and investment in the heart failure trial.

Results from the open-label roll-in cohort of patients having chronic myocardial ischemia with refractory angina showed an average 107 second increase in exercise tolerance and an 82% average reduction in angina episodes at the primary six-month follow-up endpoint compared to before receiving the study treatment. The last consented patient in the roll-in cohort was treated in August 2024, and we are gathering top linePrimary results of this cohort athave thebeen six-month primary endpointsubmitted for publicationpresentation andat presentation.Euro PCR, a world-leading course in interventional cardiovascular medicine, in May of 2026.

The FDAInvestigational approvedNew investigational new drugDrug application (IND) for a Phase I1/II2 trial to deliver our allogeneic MSC for the treatment of HFrEF includes a 3+3 roll-in dose escalation cohort now followed by a 60-patient360-patient randomized double-blind controlled study andbased on a recent IND amendment to right size the study for nondilutive funding opportunities. The study utilizes the Finkelstein Schoenfeld three tier primary composite endpoint of mortality, MACCE, and functional capacity as measured by six-minute walk distance. The low dose cohort of 20 million cells has been completed and there have been no treatment-emergent adverse events, arrhythmias, rejection, or allergic response,response. consistent with our presentation at the Technology and Heart Failure Therapeutics meeting in March 2024. Per protocol, formalThe Data Safety Monitoring Board reviewhas ofrecommended these patients will take place inthat the secondstudy quarterproceed ofas 2025.designed based on the 30-day data safety assessment from this cohort.

We intend to fund later development through nondilutive grant applicationsgrants and partnering. Phase II2 development is anticipated to be advanced in both the United States and Japan and would also enroll in approximately one year. It is expected that after the completion of this Phase 2 study that conditional approval in Japan may be pursued followed by a post-marketing study over a period of five years to further add to the evidence of safety and patient benefit.

All procedures using our Helix transendocardial delivery system include the use of a Morph steerable introducer. We are actively transitioning all procedures using our Helix transendocardial delivery system to our new FDA cleared Morph DNA platform. We received FDA market clearance of an 8 French equivalent for transseptal cardiac procedures, under the name AVANCE. One of the device’s features is that its tendons are designed to enable deflection rotation around the catheter shaft, providing uniform bending in all directions and a substantial reduction of what is called catheter “whip.” This is designed to enhance physician control for many procedures. The FDA has approved clearance the Morph-DNA product family across a range of diameters and lengths, which is now available for use in the treatment of aorto-ostial disease, including renal procedures, superior femoral artery procedures, below the knee procedures and mesenteric artery procedures.

Our primary revenuesRevenues are currently derived from our biotherapeutic delivery partnering agreements. Under these partnering agreements, we provide extensive support and our Helix biotherapeutic delivery system from the research bench to commercialization for partners. WeOur also have begun commercializing our FDA clearedFDA-cleared AVANCE and Morph DNA steerable introducer products.products are also available for commercial sale.

Selling, GeneralResearch and AdministrativeDevelopment Expenses. Selling, generalResearch and administrativedevelopment expenses decreasedincreased to approximately $3.7$5.0 million in the year ended December 31, 20242025 as compared to approximately $4.4 million in the year ended December 31, 2023,2024 primarily due to realignmentcloseout ofactivities personnel roles and cost reductions following completion ofin the CardiAMP CellHeart TherapyFailure Trial, inception of enrollment in the CardiAMP Heart Failure Trial.II Trial and regulatory activities to advance CardiAMP in Japan.

We have incurred net losses each year since our inception and as of December 31, 2024,2025, we had an accumulated deficit of approximately $160.1$168.3 million. We anticipate that we will continue to incur net losses for at least the next several years.

Cash Flows from Operating Activities. Cash flow from operating activities for any period is subject to many variables including the timing of cash receipts, payments to suppliers, and vendor payment terms. Cash flow used in operating activities decreased from approximately $10.0$7.9 million during the year ended December 31, 20232024 to approximately $8.0$7.4 million during the year ended December 31, 2024,2025, primarily due primarilyto the timing of payments to reductions in research and development expense following completion of the CardiAMP Cell Therapy Heart Failure Trial.suppliers.

Cash Flows from Financing Activities. Net cash provided by financing activities of approximately $9.3$7.6 million and approximately $3.7$9.2 million during the years ended December 31, 20242025 and 2023,2024, respectively, related to net proceeds from the sale of common stock less issuance costs.costs and taxes paid related to net share settlement of equity awards.

On December 6, 2023, we entered into an “At The Market” offering agreement (the Sales Agreement) with H.C. Wainwright & Co., LLC (HCW). Under the Sales Agreement, we may offer and sell our common stock, from time to time having an aggregate offering amount of up to $2.75 million during the term of the Sales Agreement through or to HCW as sales agent or principal, of which $264,000 was available as of September 30, 2024.principal. We have filed a prospectus supplement (the ATM Prospectus Supplement), as supplemented, relating to the offer and sale of the shares pursuant to the Sales Agreement. The offering and sale of the shares will be made pursuant to the Company’s previously filed and effective Registration Statement on Form S-3 (File No. 333-275099), which was initially filed with the Securities and Exchange Commission (the “SEC”) on October 19, 2023 and declared effective on December 5, 2023. As of March 24, 2026, under the ATM Prospectus Supplement, we may issue up to approximately $5.1 million of our common stock. We have agreed to pay HCW a commission equal to 3% of the gross proceeds from the sales of shares and have agreed to provide HCW with customary indemnification and contribution rights.

Based upon our current operating plan, we believe that the cash and cash equivalents of approximately $2.4$2.5 million as of December 31, 20242025 are not sufficient to fund our planned expenditures and meet our obligations beyond May 2025.2026. In order toTo continue development of our therapeutic candidates beyond such time, we plan to raise additional capital, potentially including non-dilutive collaboration and licensing arrangements, debt or equity financing, or a combination from these sources. We may be unsuccessful in raising funds from any or all such sources, and to the extent we raise any funds, they may be on highly dilutive terms. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our therapeutic candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development of our therapeutic candidates.

If we do not regain compliance with or continue to satisfy the Nasdaq continued listing requirements, our securities could be delisted from the Nasdaq.

IfThe listing of our common stock on the Nasdaq Capital Market (Nasdaq) is contingent on our compliance with the Nasdaq’s conditions for continued listing. We were previously not in compliance with the Nasdaq listing requirements. Although we failhave regained compliance, a future failure to regainmaintain compliance,compliance with the Nasdaq’s continued listing requirements could result in our securities will bebeing subject to delisting by the Nasdaq. In the event our securities are no longer listed for trading on Nasdaq, our trading volume and sharesecurity price may decrease and we may experience further difficulties in raising capital, which could materially affect our operations and financial results. Further, delisting from the Nasdaq could also have other negative effects, including potential loss of confidence by partners, lenders, suppliers and employees and could also trigger various defaults under our financing arrangements and other outstanding agreements. Finally, delisting could make it harder for us to raise capital and sell securities. In order to raise additional capital, we may in the future offer additional shares of our common stock or other securities convertible into, or exchangeable for, our common stock. You may experience future dilution as a result of future equity offerings.

We are a clinical-stage company developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases with significant unmet medical needs. Our CardiAMP® autologous mononuclear cell therapy platform is being advanced clinically for two cardiac clinical indications based on the mechanism of action of treating microvascular dysfunction demonstrated by these cells in preclinical studies of enhanced microvascular density and reduced fibrosis: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI). Our CardiALLO™ allogeneic mesenchymal stem cell (MSC) therapy platform is being advanced clinically as an “off the shelf” cell therapy based on the immunomodulatory mechanism of action for the treatment of ischemic inflammatory HFrEF. Our PulmALLO™ program for these same cells in the pulmonary indication of acute respiratory distress syndrome has had its investigational new drug (IND) approved by the U.S. Food and Drug Administration (FDA), but we have not yet advanced this program in the clinic..

Our therapeutic candidates intended for cardiac indications are enabled by our Helix™ transendocardial biotherapeutic delivery system,catheters whichand enablesour minimallyMorph™ invasiveDNA catheter-basedsteerable intramyocardial therapeutic delivery.introducers. We partner this therapeutic delivery platform and provide development services selectively with others seeking to develop biotherapeutic interventions for local delivery to the heart. We are developing Heart3D™ to enhance delivery for our investigational therapies and those of our partners.

We expense all research and development costs in the periods in which they are incurred. Costs for certain development activities are recognized based on an evaluation of the progress of completion of specific tasks using information and data provided to us by our vendors and clinical sites. NonrefundableNon-refundable advance payments for goods or services to be received in future periods for use in research and development activities are deferred and capitalized. The capitalized amounts are then expensed as the related goods are delivered and the services are received.

Comparison of Three and Six Months Ended MarchJune 31,30, 2026 and 2025

The following table shows our results of operations for the three and six months ended MarchJune 31,30, 2026 and 2025 (in thousands):

Research and Development Expenses. Research and development expenses decreased to $893,000 in the three months ended June 30, 2026 as compared to approximately $1.2$1.4 million in the three months ended MarchJune 31,30, 2025, and decreased to approximately $2.1 million in the six months ended June 30, 2026 as compared to approximately $1.5$2.9 million in the threesix months ended MarchJune 31,30, 2025,2025 primarily due to closeout of the CardiAMP Heart Failure Trial, partially offset by early enrollment in the CardiAMP Heart Failure II Trial and regulatory activities to advance CardiAMP in Japan.

Selling, General and Administrative Expenses. Selling, general and administrative expenses decreasedremained torelatively approximatelyconsistent $1.0at million$730,000 in the three months ended MarchJune 31,30, 2026 as compared to $683,000 in the three months ended June 30, 2025, and approximately $1.8 million in the six months ended June 30, 2026 as compared to approximately $1.2$1.9 million in the threesix months ended MarchJune 31,30, 2025, primarily due to lower professional service fees.2025.

We have incurred net losses each year since our inception and as of MarchJune 31,30, 2026, we had an accumulated deficit of approximately $170.6$172.2 million. We anticipate that we will continue to incur net losses for the next several years.

Cash Flows from Operating Activities. Cash flow from operating activities for any period is subject to many variables including the timing of cash receipts, payments to suppliers, and vendor payment terms. Cash flow used in operating activities increased to approximately $1.7$3.4 million during the threesix months ended MarchJune 31,30, 2026 as compared to approximately $1.6$3.3 million during the threesix months ended MarchJune 31,30, 2025, primarily due to the timing of payments to suppliers.

Cash Flows from Financing Activities. Net cash provided by financing activities of $117,000approximately $5.0 million and $196,000approximately $1.9 million during the threesix months ended MarchJune 31,30, 2026 and 2025, respectively, related primarily to proceeds from the sale of common stock, partially offset by payments of issuance costs.

At-the-Market (ATM) Offerings – On December 6, 2023, we entered into an “At The Market” offering agreement (the Sales Agreement) with H.C. Wainwright & Co., LLC (HCW). Under the Sales Agreement, we may offer and sell our common stock, from time to time during the term of the Sales Agreement through or to HCW as sales agent or principal. We have filed a prospectus supplement (the ATM Prospectus Supplement), as supplemented, relating to the offer and sale of the shares pursuant to the Sales Agreement. The offering and sale of the shares will bewere made pursuant to the Company’s previously filed and effective Registration Statement on Form S-3 (File No. 333-275099), which was initially filed with the Securities and Exchange Commission (the “SEC”) on October 19, 2023 and declared effective on December 5, 2023. As of MayAugust 14,11, 2026 and MarchJune 31,30, 2026, under the ATM Prospectus Supplement, we may issue up to approximately $4.5 million$0 and approximately $5.1 million$0 of our common stock, respectively. We have agreed to pay HCW a commission equal to 3% of the gross proceeds from the sales of shares and have agreed to provide HCW with customary indemnification and contribution rights.

Based upon our current operating plan, we believe that the cash and cash equivalents of $951,000approximately $4.1 million as of MarchJune 31,30, 2026 are not sufficient to fund our planned expenditures and meet our obligations beyond JuneJanuary 2026.2027. To continue development of our therapeutic candidates beyond such time, we plan to raise additional capital, potentially including non-dilutive collaboration and licensing arrangements, debt or equity financing, or a combination from these sources. We may be unsuccessful in raising funds from any or all such sources, and to the extent we raise any funds, they may be on highly dilutive terms. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our therapeutic candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development of our therapeutic candidates.

We have prepared our condensed consolidated financial statements as of MarchJune 31,30, 2026 on the basis that we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. Due to the factors described above, there is substantial doubt about our ability to continue as a going concern within one year after the date these financial statements are issued. Our ability to continue as a going concern will depend, in a large part, on our ability to raise additional capital. If adequate funds are not available, we may be required to further reduce operating expenses, delay or reduce the scope of our product development programs, obtain funds through arrangements with others that may require us to relinquish rights to certain of our technologies or products that we would otherwise seek to develop or commercialize ourselves, or cease operations. While we believe in the viability of our strategy to raise additional funds, there can be no assurances that we will be able to obtain additional capital on acceptable terms and in the amounts necessary to fully fund our operating needs.