BioCardia, Inc.

BioCardia, Inc. is a clinical-stage regenerative medicine company developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases with significant unmet medical needs. The company operates in the biotechnology and pharmaceutical industries, which are characterized by rapid change and intense competition to develop new technologies and proprietary products. The American Heart Association estimated that nearly 6.7 million American adults ages 20 and older have heart failure, with prevalence expected to increase by 55% from 2012 to 2030, affecting greater than 8.5 million people aged 18 and above, and the total percentage of the population with HF is projected to rise from 2.4% in 2012 to 3.0% in 2030, with 47% of the effective population estimated to have HFrEF. The AHA estimated that heart failure cost the nation an estimated $30.7 billion in 2012, with projections that the total cost will increase to $69.8 billion by 2030, and the AHA detailed that it affects more than 56.2 million people worldwide. In the U.S. alone, it is estimated that between 600,000 and 1.8 million patients suffer chronic myocardial ischemia with refractory angina, with approximately 75,000 new cases diagnosed each year.

BioCardia faces potential competition from many sources, including larger and better-funded companies such as AstraZeneca, Bayer, Blue Rock Therapeutics, Bristol-Myers Squibb, Lisata Therapeutics, Capricor Therapeutics, Celixir, Celyad, Daiichi Sankyo, Fuji Film, Mesoblast, Moderna, Orizuru Therapeutics, Sana Biotechnology, Takeda Pharmaceuticals, Tenaya Therapeutics, Terumo, Vericel Corp, and uniQure. The company believes its programs' unique benefits provide competitive advantages, including that the CardiAMP Cell Therapy System was the first cardiac cell therapy to receive an FDA Breakthrough designation, and that because CardiAMP cells are autologous, patients will not require chronic immunosuppression. BioCardia also believes its intellectual property position provides substantial competitive advantages, having developed or secured rights to over 70 issued or pending U.S. and international patents or patent pending applications as of December 31, 2025, with issued U.S. patents expiring between 2027 and 2040.

BioCardia generates revenue through the development and potential commercialization of its therapeutic candidates and through partnering its Helix transendocardial biotherapeutic delivery system, providing development services selectively with others seeking to develop biotherapeutic interventions for local delivery to the heart. The company's revenue model is primarily transactional, as it is a clinical-stage company with no approved cell therapy products generating commercial revenue, though it has limited approved or cleared products in its Morph universal deflectable guide catheters, AVANCE steerable introducer, and Morph DNA deflectable guides in the United States. The company's primary customer segments are cardiologists and interventional cardiologists at leading hospitals and medical centers, and its business strategy includes obtaining non-dilutive or partnering funding and selectively partnering its Helix biotherapeutic delivery system for use with other biotherapeutics.

BioCardia's CardiAMP Cell Therapy System is an autologous mononuclear cell therapy platform being advanced clinically for two cardiac clinical indications: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI). The system is comprised of a cell potency screening test, a point of care cell processing platform, and a biotherapeutic delivery system. The CardiAMP Cell Therapy System has been evaluated in three clinical trials to date for ischemic HFrEF: a Phase I open-label clinical study (TABMMI) that enrolled 20 patients with HFrEF at a dosage of 100 million cells, a Phase II randomized double-blind placebo-controlled study (TACHFT) that included patients with HFrEF randomized on a one-to-one basis, and a Phase III randomized double-blind sham-controlled study (CardiAMP HF) that enrolled 115 advanced heart failure patients on guideline directed medical therapy in addition to an initial 10-patient roll-in cohort. The CardiAMP 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, with greater than 90 percent power to meet the primary endpoint based on the CardiAMP HF Trial results. The CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial is a Phase III, multi-center, randomized, double-blinded, controlled study of up to 343 patients at up to 40 clinical sites.

BioCardia's 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 (BCDA-03) and acute respiratory distress syndrome (BCDA-04). The FDA approved IND for a Phase I/II trial to deliver allogeneic MSC for the treatment of HFrEF includes a 3+3 roll-in dose escalation cohort followed by a 60-patient randomized double-blind controlled study, and the low dose cohort of 20 million cells has been completed with no treatment-emergent adverse events, arrhythmias, rejection, or allergic response. The FDA approved IND for a Phase I/II trial for the use of its allogeneic cell therapy for ARDS caused by COVID-19 in 2022, though no milestones for this program have been set for 2026. The Helix transendocardial biotherapeutic delivery system is a therapeutic-enabling platform for minimally invasive targeted delivery of biologic agents to the heart, and in February 2026, BioCardia announced a Pre-Submission to FDA under its Q-Submission program for the approval of its Helix Transendocardial Delivery Catheter for intramyocardial therapeutic and diagnostic agent delivery, with data supporting safety and effectiveness from fifteen clinical trials of cell and gene therapy delivery to the heart using Helix. The Morph steerable introducer includes the AVANCE 8 French equivalent for transseptal cardiac procedures, and the FDA has approved clearance of the Morph-DNA product family across a range of diameters and lengths for use in aorto-ostial disease, renal procedures, superior femoral artery procedures, below the knee procedures, and mesenteric artery procedures.

In September 2025, BioCardia completed a Registered Offering pursuant to which it issued 4,800,000 shares of common stock, including shares issued upon the exercise of pre-funded warrants, and common warrants to purchase 4,800,000 shares of common stock. The company entered into a sales agreement with H.C. Wainwright & Co., LLC in December 2023 pursuant to which it may sell shares of common stock through HCW as sales agent at current market prices, with the amount covered by an effective registration statement being approximately $5.1 million as of March 24, 2026. The Department of Health & Human Services Centers for Medicare & Medicaid Services has designated that CardiAMP HF, CardiAMP HF II and CardiAMP CMI qualify for Medicare national coverage, with covered costs including patient screening, the CardiAMP Cell Therapy System and procedure at up to $17,500 for both treatment and control, and clinical follow-up at one and two years after the procedure, with private insurance plans covering 50 million insured Americans following the CMS reimbursement policy. The FDA granted Breakthrough Device Designation for the CardiAMP Cell Therapy System for the treatment of heart failure in January 2022.

BioCardia has a history of operating losses and has not yet generated a profit, with a net loss for the year ended December 31, 2025 of $8.2 million and an accumulated deficit totaling $168.3 million as of December 31, 2025. The company's cash and cash equivalents were approximately $2.5 million as of December 31, 2025, and management believes these are not sufficient to fund planned expenditures and meet obligations beyond May 2026. The company's audited consolidated financial statements have been prepared on the basis that it will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business.

BioCardia's primary growth vector is obtaining FDA and PMDA approval and commercializing the CardiAMP Cell Therapy System using a highly targeted cardiology sales force in the United States and Japan. The company is exploring approval for market release of CardiAMP in the United States with FDA and in Japan with PMDA based on the strength of clinical data, with approvals in both countries at minimum expected to require post marketing studies. In the U.S., the company expects to file a Q-Sub request with FDA on approvability of the FDA designated Breakthrough CardiAMP cell therapy device, and these discussions will be simplified by reference to the Helix as a stand-alone delivery device, which has a pre-submission actively under review by FDA. In Japan, the company has completed a number of preclinical consultations with PMDA and has scheduled a formal clinical consultation in the second quarter of 2026 to align with PMDA on the acceptability of existing clinical data from three trials to allow submission for market release. The company estimates there are more than 3 million NYHA Class II and Class III heart failure patients in the United States, of which 1.7 million patients have HFrEF, and of this subset, approximately 80%, or over 1.2 million patients, will have a cell population score sufficient to qualify for treatment with the CardiAMP Cell Therapy, while the CardiALLO allogeneic MSC therapy is designed to be suitable for all 1.7 million patients with this indication.

BioCardia's second major growth vector is completing the CardiAMP HF II IDE trials of its autologous CardiAMP Cell Therapy for patients with ischemic heart failure with HFrEF or advancing as a post marketing study, and obtaining non-dilutive or partnering funding to complete the approved Phase III pivotal IDE trial of the autologous CardiAMP Cell Therapy for patients with chronic myocardial ischemia. The CardiAMP HF II trial has greater than 90 percent power to meet the primary endpoint based on the CardiAMP HF Trial results, and the FDA approved a protocol amendment that 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, with four clinical sites activated and enrollment ongoing. The CardiAMP CMI trial is designed to enroll up to 343 patients at up to 40 clinical sites, and results from the open label roll-in cohort 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, with primary results submitted for presentation at Euro PCR in May 2026.

BioCardia does not provide specific margin trajectory, cost structure evolution, or efficiency targets with exact figures in the filing.

BioCardia currently produces its allogeneic MSC cells for clinical development in its Sunnyvale, California cell manufacturing facility, which was certified for manufacturing in 2022, and also manufactures its Helix biotherapeutic delivery system and Morph vascular access products in its Sunnyvale, California device manufacturing facility using components sourced from third-party suppliers. The CardiAMP autologous cell processing platform is manufactured for the company by its partner Biomet Biologics, LLC. As of December 31, 2025, BioCardia had 17 full-time and four part-time employees, consisting of clinical development, product development, regulatory, manufacturing, quality, finance, administration, sales, and marketing, and the company also regularly uses independent contractors across the organization.

BioCardia does not provide specific R&D spending levels, capital expenditure plans, share repurchase authorization amounts, or dividend policy with exact figures in the filing.

BioCardia faces significant structural headwinds, including that it has a history of operating losses and may not be able to achieve or sustain profitability, with net loss for the year ended December 31, 2025 of $8.2 million and accumulated deficit totaling $168.3 million as of December 31, 2025. The company will require substantial additional financing to achieve its goals, and its cash and cash equivalents of approximately $2.5 million as of December 31, 2025 are not sufficient to fund planned expenditures and meet obligations beyond May 2026. The company's ability to use its net operating loss carryforwards and certain other tax attributes may be limited, as none of its pre-Merger tax attributes remain available after the Merger as a result of limitations under Sections 382 and 383 of the Code, and prior equity offerings and other changes in stock ownership may have resulted in ownership changes.

BioCardia faces execution risks including that the CardiAMP Cell Therapy System is, to its knowledge, the first cardiac cell-based therapy with an accepted pivotal trial to be regulated by the FDA via the premarket approval pathway, making the approval process uncertain, and that no cell-based therapies have been approved in the United States for a cardiac indication. The company has encountered and may in the future encounter substantial delays in clinical studies, and may find it difficult to enroll patients in clinical trials due to factors including the size of the patient population, severity of the disease, design of the trial protocol, eligibility criteria, perceived risks and benefits, proximity and availability of clinical trial sites, availability of competing therapies and clinical trials, patient referral practices, ability to monitor patients, and the degree of treatment effect in event-driven trials.

BioCardia's most material risk is its need for substantial additional capital, as cash and cash equivalents of approximately $2.5 million as of December 31, 2025 are not sufficient to fund planned expenditures beyond May 2026, and the company has a history of operating losses with a net loss of $8.2 million for fiscal 2025 and an accumulated deficit of $168.3 million. The company's success depends on obtaining FDA approval for the CardiAMP Cell Therapy System, which is the first cardiac cell-based therapy to be regulated via the PMA pathway, and no cell-based therapies have been approved in the United States for a cardiac indication, creating significant regulatory uncertainty. The CardiAMP HF trial did not meet its primary endpoint, and while the company is pursuing approval based on subgroup analyses, there is no guarantee that the FDA will grant approval or that the ongoing CardiAMP HF II trial will succeed. The company faces intense competition from larger and better-funded companies including AstraZeneca, Bayer, Bristol-Myers Squibb, and Mesoblast, among others, and may be unable to establish sales and marketing capabilities or obtain adequate third-party reimbursement for its products if approved. The company relies on third parties for manufacturing, including its license and distribution agreement with Biomet Biologics, LLC for the CardiAMP cell processing platform, and any breach or termination of this agreement would materially adversely affect clinical development or commercialization.

Management's message to shareholders emphasizes that the company is committed to applying its expertise in autologous and allogeneic cell-based therapies to improve the lives of patients with cardiovascular and pulmonary conditions, and that the company is pursuing business strategies including obtaining FDA and PMDA approval and commercializing the CardiAMP Cell Therapy System, completing the CardiAMP HF II IDE trials, obtaining non-dilutive or partnering funding for the CardiALLO allogeneic MSC therapy and the CardiAMP CMI trial, partnering the PulmALLO allogeneic MSC therapy, and continuing to develop and selectively partner the Helix biotherapeutic delivery system and Morph catheter products. The forward-looking statements in the filing include expectations concerning the company's ability to raise additional funding from equity or debt financings and to continue as a going concern, the timing and conduct of clinical trials and clinical consultations for products, the timing or likelihood of regulatory filing, approvals and required licenses for cell therapy systems, and estimates regarding market opportunity, clinical utility, potential advantages and market acceptance of products. The strategic priorities emphasized for the period ahead are obtaining FDA and PMDA approval for the CardiAMP Cell Therapy System, completing the CardiAMP HF II confirmatory trial, and advancing the allogeneic MSC therapy programs through non-dilutive or partnering funding.