BioCardia, Inc.
For the period ended Dec 31, 2025. Filed Mar 24, 2026.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 24, 2026
BCDA$0.85-4.5%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-03-26.
0001437749-25-009397
Item 7. MANAGEMENT ’ S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-24.
0001437749-26-009587
Item 7. MANAGEMENT ’ S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe 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 85 previous paragraphs and 81 current paragraphs.
52 unchanged; 20 reworded; 8 added; 13 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 20 previous and 30 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 (8)
Current report
Clinical data from a 10-patient roll in cohort was published in 2021 in the International Journal of Cardiology. These results concluded that all CardiAMP HF protocol procedures were feasible and well tolerated. Favorable functional, echo and quality of life trends suggest this approach may offer promise. Thereafter, the randomized study enrolled 115 advanced heart failure patients on guideline directed medical therapy, in addition to the initial 10-patient roll-in cohort.
Current report
In patients with elevated NTproBNP biomarkers (50% of enrolled patients) compared to patients on optimized heart failure medication regimens alone had:
Current report
In all treated patients compared to patients on optimized heart failure medication regimen alone, the treated patients had:
Current report
On March 2, 2026, CardiAMP HF echocardiography clinical results measured by the blinded echocardiography core laboratory at the Yale University Cardiovascular Research Group were presented at the Late Breaking Clinical trial session at the Technology and Heart Failure Therapeutics conference in Boston Massachusetts. Results showed positive evidence of decreased pathological left ventricular remodeling over time in patients receiving CardiAMP cell therapy treatment compared to patients not receiving the treatment. These results correlated to findings for the trial primary and key secondary endpoints of reduced fatal and non-fatal major adverse cardiovascular events and improved quality of life measures for treated patients. The Yale core laboratory measured both left ventricular end diastolic volume, when the heart ventricle is fully dilated (p = 0.06), and the left ventricular end systolic volume, when the heart is fully contracted (p=0.09). For the prespecified subgroup of patients having elevated biomarkers of heart stress, the differences between the treated and control patients were both clinically meaningful (>20ml/m2 and 15 ml/m2, respectively) and statistically significant (p = 0.02 and p = 0.01, respectively).
Current report
We are exploring approval for market release of CardiAMP in the United States with FDA, and in Japan with PMDA, based on the strength of this excellent but imperfect data. Approvals in both countries are at minimum expected to require post marketing studies to gather additional evidence of safety and efficacy. In the U.S., we expect to file a Q-Sub request with FDA on approvability of the FDA designated Breakthrough CardiAMP cell therapy device based on its safety and compelling signals of benefit in patients with elevated biomarkers of heart stress. 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, we have completed a number of preclinical consultations with PMDA on the approvability of the CardiAMP Cell Therapy System. We have scheduled a formal clinical consultation to align with PMDA on the acceptability of the existing clinical data from the three trials to allow us to submit for market release.
Current report
In February 2026, we announced a Pre-Submission to FDA under its Q-Submission program for the approval of its Helix Transendocardial Delivery Catheter (Helix) for intramyocardial therapeutic and diagnostic agent delivery. The data supporting safety and effectiveness for the Helix Pre-Submission is from fifteen clinical trials of cell and gene therapy delivery to the heart using Helix, where patients were enrolled in three primary cardiac clinical indications. FDA has accepted the Helix pre-submission and has confirmed that it contains all of the necessary elements and information needed to proceed with substantive review. We are scheduled to meet with the FDA in the second quarter of 2026, and we expect to receive written feedback. We expect that the FDA Center for Devices and Radiological Health (CDRH) will lead the review in consultation with the FDA Center for Biologics Evaluation and Research (CBER). The FDA has acknowledged to us that the CBER Breakthrough Designation on the Helix enables in the CardiAMP Cell Therapy for ischemic heart failure.
Current report
On September 19, 2025, we issued 4,800,000 shares of our common stock, and accompanying warrants to purchase up to 4,800,000 shares of common Stock (the September 2025 Warrants), at a combined offering price of $1.25 per share and September 2025 Warrant (the September 2025 Offering). Each September 2025 Warrant is exercisable at a price per share of $1.25. The September 2025 Warrants expire on September 20, 2027, and are immediately exercisable. Certain of our directors and executive officers purchased an aggregate of 734,400 shares of common Stock and accompanying September 2025 Warrants, representing gross proceeds of $918,000. The gross proceeds of the September 2025 Offering were $6.0 million, with associated issuance costs of $837,000.
Current report
Activity under the Sales Agreement was as follows (in thousands except share amounts):
Removed paragraphs (13)
Previous report
We have submitted the Annual Report for the CardiAMP Heart Failure Trial to FDA, which details our plans for completing patient follow-up and we intend to request a meeting with FDA to discuss the results with respect to approvability of the CardiAMP Cell Therapy System. We also completed a supplementary submission to Japan Pharmaceutical and Medical Device Agency (PMDA) providing answers to PMDA’s previous responses on the approvability of the CardiAMP Cell Therapy System based on U.S. data and had a consultation in November 2024, as preparation for a subsequent clinical consultation after results from the CardiAMP Heart Failure Trial are available. Should results meet expectations, there is potential for approval based on this and previous clinical data.
Previous report
This trial also includes a 30-day window after patient consent and before baseline measures. This is intended to address the Hawthorne effect, where patient behavior changes can occur after they are under closer observation of their care providers. We have multiple consented patients in the screening queue and many sites that are at various stages of the onboarding process.
Previous report
In March 2024, we announced a biotherapeutic delivery partnership with StemCardia through a Phase I/II Clinical Study. Under the partnership, BioCardia is the exclusive biotherapeutic delivery partner for StemCardia’s cell therapy candidate through studies expected to result in FDA approval of an IND and the anticipated Phase I/II clinical development to follow. In July 2024, with our partner CellProthera, we jointly announced success from the collaborative Phase II trial of ProtheraCytes in the Excellent cell therapy study in post-myocardial infarction as well as plans to continue the relationship into a Phase III trial.
Previous report
In July 2024, we completed our planned submission to the FDA for clearance of a Morph-DNA product family across a range of diameters and lengths. This product family was designed for the treatment of aorto-ostial disease, including renal procedures, superior femoral artery procedures, below the knee procedures and mesenteric artery procedures. The FDA approved this product family for market release in August 2024. The first commercial devices in 45 cm and 70 cm in 8 French configurations are now available, with additional models to be available in later in 2025.
Previous report
Cash Flows from Investing Activities. Net cash used in investing activities of $6,000 and $12,000 during the years ended December 31, 2024 and 2023, respectively, consisted of purchases of property and equipment, primarily lab and office equipment.
Previous report
On August 29, 2024, we entered into securities purchase agreements (the Purchase Agreements) with certain purchasers, pursuant to which we agreed to issue, and sell and the purchasers, in the aggregate, to buy, in a public offering (the Registered Offering) (i) 1,377,990 shares of our common stock, $0.001 par value per share (the Common Stock), and accompanying warrants to purchase up to 1,377,990 shares of Common Stock (the Common Warrants), at an offering price of $3.00 per share of Common Stock and accompanying Common Warrant, and (ii) pre-funded warrants (the “Pre-Funded Warrants” and, together with the Common Warrants, the “Warrants”) to purchase up to 1,022,010 shares of Common Stock and accompanying Common Warrants to purchase up to 1,022,010 shares of Common Stock, at an offering price of $2.999 per Pre-Funded Warrant and accompanying Common Warrant. Certain of the Company’s directors and executive officers purchased an aggregate of 211,000 shares of Common Stock and accompanying Common Warrants. The Registered Offering closed on September 3, 2024, with the Company issuing 2,400,000 shares of Common Stock, including the exercise of the Pre-Funded Warrants, and Common Warrants to purchase 2,400,000 shares of Common Stock. Each Common Warrant is exercisable at a price per share of $3.00 and expires on September 3, 2029. The gross proceeds of the Registered Offering were $7.2 million, with associated issuance costs of $926,000.
Previous report
On November 16, 2023, we sold to a single healthcare-focused institutional investor 133,333 shares of our common stock in a registered direct offering (the November 2023 RDO Offering) at a price of $9.75 per share. The gross proceeds of the November 2023 RDO Offering were $1.3 million, with associated issuance costs of $312,000.
Previous report
June 2023 Financing
Previous report
On June 21, 2023, we sold to certain existing investors and other institutional investors, as well as certain of our directors and executive officers, 75,543 shares of our common stock in a registered direct offering (the June 2023 Offering) at an offering price of $35.04 per share. Certain of our directors and executive officers purchased an aggregate of 13,556 of such shares. The gross proceeds of the June 2023 Offering were approximately $2.6 million, with associated issuance costs of $194,000.
Previous report
On April 12, 2022, we entered into a sales agreement (Cantor Sales Agreement) with Cantor Fitzgerald & Co. (Cantor) as the sales agent, pursuant to which we may offer and sell, from time to time, through Cantor, shares of common stock having an aggregate offering price of up to $10.5 million (ATM Offering). Under the terms of the Cantor Sales Agreement, Cantor was paid a commission of 3% of the aggregate proceeds from the sale of shares and reimbursed certain legal fees. The prospectus supplement expired in conjunction with the expiration of the corresponding registration statement on October 20, 2023. On June 20, 2023, we agreed with Cantor to indefinitely suspend sales under the ATM Offering, and on November 14, 2023, we agreed to terminate the Cantor Sales Agreement.
Previous report
On December 2, 2024, we filed a prospectus supplement to the ATM Prospectus Supplement that updated the maximum aggregate offering amount to approximately $1.3 million.
Previous report
During the years ended December 31, 2024 and 2023, we sold an aggregate of 428,864 and 14,349 shares of common stock under the ATM Offerings at then-market prices for total gross proceeds of approximately $2.5 million and $441,000, with associated issuance costs of $94,000 and $179,000, respectively. As of December 31, 2024, approximately $1.3 million
Previous report
of common stock may still be sold pursuant to the Sales Agreement.
Reworded paragraphs (20)
Previous wording
The CardiAMP Heart Failure Trial is a randomized, double-blinded, placebo procedure controlled, multi-center pivotal clinical trial for the treatment of heart failure of reduced ejection fraction (HFrEF). The trial is assessing the safety and effectiveness of the CardiAMP Cell Therapy System for the treatment HFrEF, an investigational device system that has received Breakthrough Device Designation from the FDA. The CardiAMP autologous cell therapy is delivered during a standard minimally invasive catheter-based procedure. Patients are typically discharged after an overnight stay. The cell therapy is designed to promote microvascular repair through enhanced capillary density and reduced fibrosis, both of which have been demonstrated in small and large animal models of disease.
Current wording
The CardiAMP Heart Failure Trial was 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 assessed 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 therapy, which is designed to promote microvascular repair through enhanced capillary density and reduced fibrosis, was delivered during a standard minimally invasive catheter-based procedure. Patients were typically discharged after an overnight stay.
Previous wording
The study enrolled 115 advanced heart failure patients on guideline directed medical therapy, in addition to a 10-patient roll-in cohort. The last protocol specified follow-up visit was completed in October 2024. Close out visits, data monitoring with source data verification and data freeze of primary outcome measures have been completed and final data has been transferred to the independent Statistical Data Analysis Core at the University of Wisconsin. Principal results from the trial are scheduled to be presented at the Late-Breaking Clinical Trials symposium at the American College of Cardiology (ACC) Scientific Sessions on March 30, 2025.
Current wording
Principal results from the trial were presented at the Late-Breaking Clinical Trials symposium at the American College of Cardiology (ACC) Scientific Sessions in March 2025. While the trial did not meet the primary endpoint, two-year results from the trial demonstrated:
Previous wording
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.
Current wording
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.
Previous wording
In August 2024, the 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.
Current wording
The FDA approved a protocol amendment for 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.
Previous wording
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.
Current wording
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.
Previous wording
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 line results of this cohort at the six-month primary endpoint for publication and presentation.
Current wording
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. Primary results of this cohort have been submitted for presentation at Euro PCR, a world-leading course in interventional cardiovascular medicine, in May of 2026.
Previous wording
The FDA approved investigational new drug application (IND) for a Phase I/II trial to deliver our 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 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, consistent with our presentation at the Technology and Heart Failure Therapeutics meeting in March 2024. Per protocol, formal Data Safety Monitoring Board review of these patients will take place in the second quarter of 2025.
Current wording
The Investigational New Drug application (IND) for a Phase 1/2 trial to deliver our allogeneic MSC for the treatment of HFrEF includes a 3+3 roll-in dose escalation cohort now followed by a 360-patient randomized double-blind controlled study based 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. The Data Safety Monitoring Board has recommended that the study proceed as designed based on the 30-day data safety assessment from this cohort.
Previous wording
We intend to fund later development through nondilutive grant applications and partnering. Phase II development is anticipated to be advanced in both the United States and Japan and would also enroll in approximately one year.
Current wording
We intend to fund development through nondilutive grants and partnering. Phase 2 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.
Previous wording
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.
Current wording
All procedures using our Helix transendocardial delivery system include the use of a Morph steerable introducer. 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.
Previous wording
Our primary revenues are 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. We also have begun commercializing our FDA cleared AVANCE and Morph DNA steerable introducer products.
Current wording
Revenues 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. Our FDA-cleared AVANCE and Morph DNA steerable introducer products are also available for commercial sale.
Previous wording
Revenue. Revenue was $58,000 in the year ended December 31, 2024 as compared to $477,000 in the year ended December 31, 2023. The amount and timing of collaboration revenues is largely dependent on our partners’ development activities and may be inconsistent and create significant variation in our revenues.
Current wording
Revenue. Revenue was $0 in the year ended December 31, 2025 as compared to $58,000 in the year ended December 31, 2024. The amount and timing of collaboration revenues is largely dependent on our partners’ development activities and may be inconsistent and create significant variation in our revenues.
Previous wording
Research and Development Expenses. Research and development expenses decreased to approximately $4.4 million in the year ended December 31, 2024 as compared to approximately $7.7 million in the year ended December 31, 2023 primarily due to reduced personnel costs and clinical expenses following the completion of the CardiAMP Cell Therapy Heart Failure Trial.
Current wording
Research and Development Expenses. Research and development expenses increased to approximately $5.0 million in the year ended December 31, 2025 as compared to approximately $4.4 million in the year ended December 31, 2024 primarily due to closeout activities in the CardiAMP Heart Failure Trial, inception of enrollment in the CardiAMP Heart Failure II Trial and regulatory activities to advance CardiAMP in Japan.
Previous wording
Selling, General and Administrative Expenses. Selling, general and administrative expenses decreased to approximately $3.7 million in the year ended December 31, 2024 as compared to approximately $4.4 million in the year ended December 31, 2023, primarily due to realignment of personnel roles and cost reductions following completion of the CardiAMP Cell Therapy Heart Failure Trial.
Current wording
Selling, General and Administrative Expenses. Selling, general and administrative expenses decreased to approximately $3.3 million in the year ended December 31, 2025 as compared to approximately $3.7 million in the year ended December 31, 2024, primarily due to lower professional service fees coupled with lower share-based compensation expense.
Previous wording
We have incurred net losses each year since our inception and as of December 31, 2024, we had an accumulated deficit of approximately $160.1 million. We anticipate that we will continue to incur net losses for at least the next several years.
Current wording
We have incurred net losses each year since our inception and as of December 31, 2025, we had an accumulated deficit of approximately $168.3 million. We anticipate that we will continue to incur net losses for the next several years.
Previous wording
We have funded our operations principally through the sales of equity and convertible debt securities. As of December 31, 2024, we had cash and cash equivalents of approximately $2.4 million.
Current wording
We have funded our operations principally through the sales of equity and convertible debt securities. As of December 31, 2025, we had cash and cash equivalents of approximately $2.5 million.
Previous wording
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 million during the year ended December 31, 2023 to approximately $8.0 million during the year ended December 31, 2024, due primarily to reductions in research and development expense following completion of the CardiAMP Cell Therapy Heart Failure Trial.
Current wording
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 $7.9 million during the year ended December 31, 2024 to approximately $7.4 million during the year ended December 31, 2025, primarily due to the timing of payments to suppliers.
Previous wording
Cash Flows from Financing Activities. Net cash provided by financing activities of approximately $9.3 million and approximately $3.7 million during the years ended December 31, 2024 and 2023, respectively, related to net proceeds from the sale of common stock less issuance costs.
Current wording
Cash Flows from Financing Activities. Net cash provided by financing activities of approximately $7.6 million and approximately $9.2 million during the years ended December 31, 2025 and 2024, respectively, related to net proceeds from the sale of common stock less issuance costs and taxes paid related to net share settlement of equity awards.
Previous wording
On February 9, 2024, we entered into a Securities Purchase and Registration Rights Agreement relating to a private placement with certain qualified institutional buyers and institutional accredited investors, which closed on February 13, 2024. Pursuant to the agreement, we sold 134,199 shares of our common stock, and warrants to purchase 67,104 shares of our common stock at an exercise price equal to $6.60 per warrant share, subject to certain adjustments, as provided under the terms of the warrant, which are exercisable at any time before February 13, 2026. The gross proceeds of the Offering were $875,000, with associated issuance costs of $43,000.
Current wording
On April 22, 2025, we entered into a Securities Purchase and Registration Rights Agreement relating to a private placement with certain qualified institutional buyers and institutional accredited investors (the April 2025 Offering), which closed on April 23, 2025. Pursuant to the agreement, we sold 406,818 shares of our common stock, and warrants to purchase an aggregate of 406,818 shares of our common stock at an exercise price equal to $1.905 per share, which are exercisable at any time before the earlier of April 24, 2030 or the approval by the Japanese Pharmaceuticals and Medical Devices Agency of our application of our CardiAMP Cell Therapy System. The gross proceeds of the April 2025 Offering were $775,000, with associated issuance costs of $56,000.
Previous wording
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. We have filed a prospectus supplement (the ATM Prospectus Supplement) 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. 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.
Current wording
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 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.
Previous wording
Based upon our current operating plan, we believe that the 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. In order 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.
Current wording
Based upon our current operating plan, we believe that the 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. 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.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
On June 30, 2025, we entered into a Securities Purchase and Registration Rights Agreement relating to a private placement with certain qualified institutional buyers and institutional accredited investors, as well as certain members of our board of directors and executive officers (the June 2025 Offering), which closed on June 30, 2025. Pursuant to the agreement, we sold 274,696 shares of our common stock, and warrants to purchase an aggregate of 274,696 shares of our common stock at an exercise price equal to $1.95 per share, which are exercisable at any time before the earlier of June 30, 2030 or the approval by the Japanese Pharmaceuticals and Medical Devices Agency of our application of our CardiAMP Cell Therapy System. The gross proceeds of the June 2025 Offering were $570,000, with associated issuance costs of $9,000.