BioCardia Reports Second Quarter 2025 Business Highlights and Financial Results
BioCardia (NASDAQ:BCDA) reported Q2 2025 financial results and significant progress in its cardiovascular therapeutics pipeline. The company's flagship CardiAMP HF Trial showed promising two-year results, with treatment groups demonstrating lower incidence of death and complications, particularly significant in patients with elevated NTproBNP (p=0.02).
Financial highlights include increased R&D expenses to $1.4M in Q2 2025, a net loss of $2.0M, and a current cash balance of approximately $1.1M providing runway into October 2025. The company strengthened its intellectual property portfolio with a new US patent for its biotherapeutic delivery catheter systems.
Key upcoming milestones include FDA meetings on CardiAMP HF approvability in Q4 2025, Japan PMDA clinical review, and planned FDA submission for the Helix biotherapeutic delivery system in Q3 2025.
BioCardia (NASDAQ:BCDA) ha comunicato i risultati finanziari del Q2 2025 e segnala progressi significativi nel suo portafoglio di terapie cardiovascolari. Lo studio principale, CardiAMP HF Trial, ha mostrato risultati promettenti a due anni: i gruppi trattati hanno registrato una minore incidenza di decessi e complicazioni, con una differenza particolarmente significativa nei pazienti con NTproBNP elevato (p=0.02).
I punti finanziari chiave includono un aumento delle spese di R&S a $1.4M nel Q2 2025, una perdita netta di $2.0M e una posizione di cassa attuale di circa $1.1M, che offre copertura fino a ottobre 2025. L'azienda ha inoltre rafforzato il proprio portafoglio di propriet脿 intellettuale con un nuovo brevetto statunitense per i sistemi di cateteri destinati alla somministrazione di bioterapici.
I prossimi traguardi prevedono incontri con la FDA per discutere l'approvabilit脿 del CardiAMP HF nel Q4 2025, la revisione clinica da parte del PMDA in Giappone e la prevista sottomissione alla FDA per il sistema di somministrazione bioterapica Helix nel Q3 2025.
BioCardia (NASDAQ:BCDA) dio a conocer los resultados financieros del 2T 2025 y avances significativos en su cartera de terapias cardiovasculares. El estudio principal, CardiAMP HF Trial, present贸 resultados prometedores a dos a帽os: los grupos tratados mostraron menor incidencia de muerte y complicaciones, siendo la diferencia especialmente significativa en pacientes con NTproBNP elevado (p=0.02).
Entre los aspectos financieros destacan un aumento en gastos de I+D a $1.4M en el 2T 2025, una p茅rdida neta de $2.0M y un saldo de caja actual de aproximadamente $1.1M, que proporciona liquidez hasta octubre de 2025. La compa帽铆a fortaleci贸 su cartera de propiedad intelectual con una nueva patente en EE. UU. para sus sistemas de cat茅teres de administraci贸n de bioterap茅uticos.
Los hitos pr贸ximos incluyen reuniones con la FDA sobre la aprobabilidad de CardiAMP HF en el Q4 2025, la revisi贸n cl铆nica por parte del PMDA en Jap贸n y la presentaci贸n prevista a la FDA del sistema de administraci贸n bioterap茅utica Helix en el Q3 2025.
BioCardia (NASDAQ:BCDA)電� 2025雲� 2攵勱赴 鞛鞁れ爜瓿� 鞁槇甏� 旃橂鞝� 韺岇澊頂勲澕鞚胳潣 欤检殧 歆勳爠鞚� 氚滍憸頄堨姷雼堧嫟. 頃奠嫭 鞐瓣惮鞚� CardiAMP HF Trial鞚� 2雲� 於旍爜 瓴瓣臣鞐愳劀 鞙犽頃� 靹标臣毳� 氤挫榾鞙茧┌, 旃橂甑办棎靹� 靷 氚� 頃╇硲歃� 氚滌儩毳犾澊 雮晿瓿� NTproBNP臧� 雴掛潃 頇橃瀽甑办棎靹� 韸鬼瀳 鞙犾潣氙疙暅 彀澊毳� 氤挫榾鞀惦媹雼� (p=0.02).
鞛 頃橃澊霛检澊韸鸽電� 2025雲� 2攵勱赴 鞐瓣惮臧滊皽牍勱皜 $1.4M搿� 歃濌皜頄堨溂氅�, 靾滌啇鞁れ潃 $2.0M, 順勳灛 順勱笀 鞛旉碃電� 鞎� $1.1M鞙茧 2025雲� 10鞗旉箤歆�鞚� 鞖挫榿 鞛愱笀鞚� 頇曤炒霅橃柎 鞛堨姷雼堧嫟. 霕愴暅 靸濍旃橂鞝� 韴棳鞖� 旃错厡韯� 鞁滌姢韰滌棎 雽�頃� 氙戈淡 鞁犼窚 韸鬼棃毳� 韱淀暣 歆�鞁濎灛靷� 韽姼韽措Μ鞓るゼ 臧曧檾頄堨姷雼堧嫟.
欤检殧 頄ロ泟 鞚检爼鞙茧電� 2025雲� 4攵勱赴 欷� CardiAMP HF鞚� 鞀轨澑 臧�電レ劚鞐� 雽�頃� FDA 須岇潣, 鞚茧掣 PMDA鞚� 鞛勳儊 鞁偓, 攴鸽Μ瓿� 2025雲� 3攵勱赴 鞓堨爼鞚� Helix 靸濍旃橂鞝� 鞝勲嫭 鞁滌姢韰滌棎 雽�頃� FDA 鞝滌稖鞚� 韽暔霅╇媹雼�.
BioCardia (NASDAQ:BCDA) a publi茅 ses r茅sultats financiers du T2 2025 et fait 茅tat de progr猫s significatifs dans son portefeuille de th茅rapeutiques cardiovasculaires. L'essai principal, CardiAMP HF Trial, a livr茅 des r茅sultats prometteurs 脿 deux ans鈥�: les groupes trait茅s ont pr茅sent茅 une moindre incidence de d茅c猫s et de complications, diff茅rence particuli猫rement significative chez les patients ayant un NTproBNP 茅lev茅 (p=0.02).
Parmi les points financiers figurent une hausse des d茅penses R&D 脿 $1.4M au T2 2025, une perte nette de $2.0M et une tr茅sorerie actuelle d'environ $1.1M, assurant une visibilit茅 jusqu'en octobre 2025. La soci茅t茅 a renforc茅 son portefeuille de propri茅t茅 intellectuelle avec un nouveau brevet am茅ricain pour ses syst猫mes de cath茅ters destin茅s 脿 l'administration de bioth茅rapies.
Les jalons 脿 venir incluent des r茅unions avec la FDA sur l'approvabilit茅 de CardiAMP HF au T4 2025, l'examen clinique par le PMDA au Japon et le d茅p么t pr茅vu aupr猫s de la FDA du syst猫me d'administration bioth茅rapeutique Helix au T3 2025.
BioCardia (NASDAQ:BCDA) ver枚ffentlichte die Finanzergebnisse f眉r das 2. Quartal 2025 und berichtet 眉ber erhebliche Fortschritte in seiner kardiovaskul盲ren Wirkstoffpipeline. Die Flaggschiff-Studie, CardiAMP HF Trial, zeigte vielversprechende Zwei-Jahres-Ergebnisse: die behandelten Gruppen wiesen eine geringere Sterblichkeits- und Komplikationsrate auf, besonders ausgepr盲gt bei Patienten mit erh枚htem NTproBNP (p=0.02).
Zu den finanziellen Eckdaten z盲hlen
Wichtige bevorstehende Meilensteine sind FDA-Gespr盲che zur Zulassungsf盲higkeit von CardiAMP HF im Q4 2025, die klinische Pr眉fung durch die japanische PMDA sowie die geplante FDA-Einreichung f眉r das Helix-Biotherapeutika-Verabreichungssystem im Q3 2025.
- Positive two-year results from CardiAMP HF Trial showing lower death and complications rates
- Statistically significant results (p=0.02) in patient subgroup with elevated NTproBNP
- Medicare reimbursement of $17,500 for both treated and control patients
- New US patent granted for biotherapeutic delivery catheter systems
- CardiAMP chronic myocardial ischemia therapy showed 82% reduction in angina episodes
- Increased net loss to $2.0M in Q2 2025 from $1.6M in Q2 2024
- Limited cash runway only extending into October 2025
- Ongoing dilution through ATM program with 296,422 shares sold at $2.59/share
- Higher R&D expenses impacting financial performance
Insights
BioCardia shows promising clinical results but faces critical cash constraints with only two months of runway remaining.
BioCardia's Q2 2025 report reveals encouraging progress for their CardiAMP cell therapy platform, with notable two-year results from their Phase 3 trial showing reduced all-cause death and non-fatal MACCE compared to controls. Particularly impressive is the statistically significant composite endpoint (p=0.02) in patients with elevated NTproBNP, potentially supporting a targeted approach for approval. Their chronic myocardial ischemia program also demonstrates promise with an average 107-second increase in exercise tolerance and 82% reduction in angina episodes at six months.
The company is pursuing multiple regulatory pathways simultaneously 鈥� seeking FDA breakthrough designation approval, initiating discussions with Japan's PMDA, and planning a DeNovo 510(k) submission for their Helix delivery system. Their confirmatory CardiAMP HF II Phase 3 trial is actively enrolling with Medicare reimbursement of
However, the financial situation is concerning. Their cash balance of only
BioCardia faces imminent cash crunch despite promising clinical developments, creating urgent financing pressure.
BioCardia's financial position is deteriorating rapidly amid increasing clinical development expenses. The company reported cash of just
Their burn rate is accelerating, with R&D expenses increasing 75% year-over-year to
Despite the financial concerns, there are positive operational developments. The company has Medicare reimbursement of
SUNNYVALE, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) -- 听[Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the second quarter of 2025 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2025 with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights. Following management鈥檚 formal remarks, there will be a question-and-answer session.
Recent Business Highlights
CardiAMP庐 autologous cell therapy in ischemic heart failure of reduced ejection fraction (BCDA-01)
- Two-year results from the double-blind randomized placebo-controlled Phase 3 CardiAMP HF Trial of CardiAMP autologous minimally invasive cell therapy for the treatment of ischemic heart failure in patients with reduced ejection fraction (HFrEF) were presented as a late-breaking clinical trial at the American College of Cardiology鈥檚 Annual Scientific Sessions on March 30, 2025. For study subjects, all on stable guideline directed medical therapy, the CardiAMP HF treatment group had a lower incidence of both all cause death and non-fatal MACCE than the control group during the entire 24-month period of the CardiAMP HF study (p=0.17) and the composite endpoint of all cause death, non-fatal MACCE, and quality of life was statistically significant in the subgroup of patients with elevated NTproBNP (p =0.02).
- CardiAMP HF Trial data has been submitted to Japan鈥檚 Pharmaceuticals and Medical Devices Agency (PMDA) and we have requested a meeting to receive advice to align with PMDA on the acceptability of the clinical data and positioning of the CardiAMP system for Japanese patients with heart failure. We anticipate an in-person consultation in the fourth quarter of 2025, the outcome of which could enable us to submit for approval of the CardiAMP system for market entry in Japan.
- We have reported parallel ongoing efforts towards requesting a meeting with the FDA on the approvability of the FDA Designated Breakthrough CardiAMP System based on this clinical data in the fourth quarter 2025.
- The confirmatory CardiAMP HF II phase 3 trial is underway in the United States, with four sites actively enrolling patients and additional sites being onboarded. This trial focuses on patients with active heart stress with a primary composite endpoint of all cause death, non-fatal MACCE, and quality of life achieved in CardiAMP HF (p=0.02). CardiAMP HF II includes using the cell population analysis at screening to define treatment doses, which enables more patients to be eligible for the therapy, and improvements to the Helix system, with the use of the FDA approved Morph DNA steerable platform. Medicare reimbursement for both treated and controlled patients under C9782 is currently
$17,500 , which helps offset the costs of this study and reported as a reduction in R&D expense.
CardiAMP autologous cell therapy in chronic myocardial ischemic with refractory angina (BCDA-02)
- Results from the open-label roll-in cohort of patients having chronic myocardial ischemia with refractory angina to date have shown 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 CardiAMP cell therapy procedure for chronic myocardial ischemia is also reimbursed by CMS under reimbursement code C9782, which covers both treated and controlled patients. The last roll-in cohort patient has reached this six-month primary endpoint, and we intend to prepare the primary results of this cohort for publication and presentation.
CardiALLO allogeneic cell therapy in Ischemic Heart Failure (BCDA-03)
- The Investigational New Drug application (IND) for a Phase 1/2 trial to deliver our allogeneic MSC for the treatment of HFrEF follows our previous cosponsored TRIDENT and POSEIDON clinical trials enrolling 45 patients at dosages up to 100 million cells delivered with our Helix transendocardial catheter. The current trial includes a 3+3 roll-in dose escalation up to a dose of 200 million cells followed by a 30-patient randomized double-blind controlled study based on a recent IND amendment to right size the study for nondilutive funding opportunities which are under discussion. The low dose cohort of 20 million cells has been completed and there have been no treatment-emergent adverse events, arrhythmias, rejection, or allergic responses. The independent Data Safety Monitoring Board recommended that the study proceed as designed in April 2025 based on the 30-day data safety assessment from this cohort.
Helix Biotherapeutic Delivery
- The Helix transendocardial biotherapeutic delivery system is a therapeutic-enabling platform for minimally invasive targeted delivery of biologic agents to the heart and underlies BCDA-01, 02, and 03 programs. We recently announced our intent to submit for approval of the Helix transendocardial system as a DeNovo 510(k) in the third quarter 2025.
Intellectual Property
- The Company鈥檚 intellectual property portfolio was strengthened with the issuance of another patent this past quarter. In June, the Company announced that the that United States Patent Office has granted US patent No. 12,311,127 titled 鈥淩adial and Trans-endocardial Delivery Catheter.鈥� The patent describes the Company鈥檚 minimally invasive interventional biotherapeutic delivery catheter systems to deliver biologic therapies to target sites in the heart. This minimally invasive delivery approach enables optimal, site-specific treatment, minimizes off-target toxicities, and avoids the need for surgical access to the heart. The allowed patent protects BioCardia鈥檚 helical needle-tipped catheter technology platform, which the scientific literature supports is the safest1 and most efficient2 approach for biotherapeutic delivery to the heart.
鈥淗eart failure remains a large, unmet need, impacting the lives of 56 million people worldwide, and we have made significant progress advancing our autologous CardiAMP cell therapy candidate intended to promote increased microvascular density and reduce fibrosis for a significant subgroup of these patients,鈥� said BioCardia CEO Peter Altman, Ph.D. 鈥淥ur active discussions on the approvability of the CardiAMP Cell Therapy System, as well the anticipated submission for approval of its dedicated Helix transendocardial biotherapeutic delivery catheter with even broader therapeutic impact have potential to be transformative for patients, physicians, and shareholders alike.鈥�
Second Quarter 2025 Financial Results:
- Research and development expenses increased to approximately
$1.4 million for the three months ended June 2025 from approximately$0.8 million in the three months ended June 2024, and increased to approximately$2.9 million in the six months ended June 2025 from the six months ended June 2024, primarily due to closeout activities in the CardiAMP HF Trial and the beginning of enrollment in the CardiAMP HF II Trial. - Selling, general and administrative expenses decreased to approximately
$0.7 million in the three months ended June 2025 compared to approximately$0.9 million for the three months ended June 2024, primarily due to lower professional fees and share-based compensation expense. Selling, general and administrative expenses remained consistent at approximately$1.9 million in the six months ended June 2025, as compared to approximately$1.9 million in the six months ended June 2024. - Our net loss was approximately
$2.0 million for the three months ended June 2025, compared to approximately$1.6 million for the three months ended June 2024, and was approximately$4.8 million for the six months ended June 2025, compared to approximately$3.9 million for the six months ended June 2024. These increases were due primarily to the increased expenses associated with closeout activities in the CardiAMP HF Trial and the beginning of enrollment in the CardiAMP HF II Trial. - Net cash used in operations for the three months ended June 2025 was approximately
$1.6 million , as compared to approximately$1.3 million for the three months ended June 2024. Net cash used in operations for the six months ended June 2025 was approximately$3.3 million , as compared to approximately$2.8 million for the six months ended June 2024. - Our cash balance on June 30, 2025, was approximately
$980,000. During the period from July 1, 2025 to August 8, 2025, we sold an aggregate of 296,422 shares of common stock under our ATM program at an average price of$2.59 per share to total gross proceeds of$769,000. T his brings our current cash balance to approximately$1.1 million and provides runway into October 2025.
ANTICIPATED UPCOMING MILESTONES AND EVENTS:
BCDA-01 CardiAMP Autologous Cell Therapy in Heart Failure (HF)
- CardiAMP HF manuscript 鈥� Q4 2025
- CardiAMP HF Japan PMDA Clinical Review 鈥� Q4 2025
- CardiAMP HF FDA meetings on approvability based on subgroup and safety 鈥� Q4 2025
- CardiAMP HF II Enrollment 鈥� Ongoing听 听 听 听 听 听
BCDA-02 CardiAMP Autologous Cell Therapy in Chronic Myocardial Ischemia
- CardiAMP CMI Top line Data Rollin Cohort 鈥� Q4 2025
BCDA-03 CardiALLO Allogeneic MSC Cell Therapy in Heart Failure
- CardiALLO HF Nondilutive Funding 鈥� Q1 2026
Helix Biotherapeutic Delivery System
- Helix biotherapeutic delivery FDA Submission for Approval 鈥� Q3 2025
About BioCardia
, headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP庐 autologous and CardiALLOTM allogeneic cell therapies are the Company鈥檚 biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its HelixTM biotherapeutic delivery and Morph庐 vascular navigation platforms. The CardiAMP Cell Therapy Trial for Heart Failure has been supported financially by the Maryland Stem Cell Research Fund and the Center for Medicare and Medicaid Services. For more information visit:听.
Forward Looking Statements
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the enrollment in our clinical trials, the availability of data from our clinical trials, filings and communications with the FDA and Japan鈥檚 PMDA, product clearances, the efficacy and safety of our products and therapies, the achievement of any of the anticipated upcoming milestones, our positioning for growth or the market for our products and therapies, the expected benefits of our intellectual property, future prospects, regulatory timelines, and other statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia鈥檚 business and product development plans, the ability to enter into licensing and partnering arrangements and overall market conditions.听We may find it difficult to enroll patients in our clinical trials due to many factors, some of which are outside of our control. Slower than targeted enrollment could delay completion of our clinical trials and delay or prevent the development of our therapeutic candidates. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.
We may use terms such as 鈥渂elieves,鈥� 鈥渆stimates,鈥� 鈥渁nticipates,鈥� 鈥渆xpects,鈥� 鈥減lans,鈥� 鈥渋ntends,鈥� 鈥渕ay,鈥� 鈥渃ould,鈥� 鈥渕ight,鈥� 鈥渨ill,鈥� 鈥渟hould,鈥� 鈥渁pproximately鈥� or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia鈥檚 Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled 鈥淩isk Factors BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.鈥澨�
1. Raval AN and Pepine CJ. Clinical Safety Profile of Transendocardial Catheter Injection Systems: A Plea for Uniform Reporting, Cardiovasc Revasc Med, 2021.
2. Mitsutake Y, Pyum WB, Rouy D, et al. Improvement of local cell delivery using Helix Transendocardial Delivery Catheter in a porcine heart, Int Heart J. 2017.听
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| 听 | Collaboration agreement revenue | $ | 鈥� | 听 | $ | 3 | 听 | 听 | $ | 鈥� | 听 | $ | 58 | 听 | ||
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| 听 | Research and development | 听 | 1,368 | 听 | 听 | 800 | 听 | 听 | 听 | 2,898 | 听 | 听 | 2,041 | 听 | ||
| 听 | Selling, general and administrative | 听 | 683 | 听 | 听 | 852 | 听 | 听 | 听 | 1,879 | 听 | 听 | 1,941 | 听 | ||
| 听 | 听 | Total costs and expenses | 听 | 2,051 | 听 | 听 | 1,652 | 听 | 听 | 听 | 4,777 | 听 | 听 | 3,982 | 听 | |
| 听 | 听 | Operating loss | 听 | (2,051 | ) | 听 | (1,649 | ) | 听 | 听 | (4,777 | ) | 听 | (3,924 | ) | |
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| 听 | 听 | Total other income, net | 听 | 听 | 2 | 听 | 听 | 3 | 听 | 听 | 听 | 16 | 听 | 听 | 11 | 听 |
| Net loss | $ | (2,049 | ) | $ | (1,646 | ) | 听 | $ | (4,761 | ) | $ | (3,913 | ) | |||
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| Net loss per share, basic and diluted | $ | (0.40 | ) | $ | (0.88 | ) | 听 | $ | (0.98 | ) | $ | (2.20 | ) | |||
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| 听 | net loss per share, basic and diluted | 听 | 5,059,736 | 听 | 听 | 1,877,069 | 听 | 听 | 听 | 4,848,922 | 听 | 听 | 1,776,305 | 听 | ||
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| 听 | 听 | June 30, 2025(1) | 听 | 听 | 听 | December 31, 2024(1) |
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| Cash and cash equivalents | $ | 980 | 听 | 听 | $ | 2,371 |
| Other current assets | 听 | 219 | 听 | 听 | 听 | 251 |
| Property, plant and equipment and other noncurrent assets | 听 | 890 | 听 | 听 | 听 | 1,102 |
| Total assets | $ | 2,089 | 听 | 听 | $ | 3,724 |
| Liabilities and Stockholders' Equity (Deficit) | 听 | 听 | 听 | 听 | 听 | 听 |
| Current liabilities | $ | 3,642 | 听 | 听 | $ | 2,321 |
| Operating lease liability - noncurrent | 听 | 333 | 听 | 听 | 听 | 566 |
| Total stockholders' equity (deficit) | 听 | (1,886 | ) | 听 | 听 | 837 |
| Total liabilities and stockholders' equity (deficit) | $ | 2,089 | 听 | 听 | $ | 3,724 |
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| (1) June 30, 2025 amounts are unaudited. December 31, 2024 amounts were derived from the audited Consolidated Financial Statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission on March 26, 2025.听 | ||||||
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Media Contact:
Miranda Peto, Investor Relations
Email:听
Phone: 650-226-0120
Investor Contact:
David McClung, Chief Financial Officer
Email:听
Phone: 650-226-0120
FAQ
What were the key findings from BioCardia's (BCDA) CardiAMP HF Trial in 2025?
How much cash does BioCardia (BCDA) have as of Q2 2025?
What is the Medicare reimbursement rate for BioCardia's CardiAMP therapy?
What are BioCardia's (BCDA) major upcoming milestones for 2025?
How did BioCardia's (BCDA) financial performance change in Q2 2025?
What results did BioCardia report for its chronic myocardial ischemia therapy?
