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 proprietà 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'approvabilità 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, presentó resultados prometedores a dos años: 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 pérdida neta de $2.0M y un saldo de caja actual de aproximadamente $1.1M, que proporciona liquidez hasta octubre de 2025. La compañía fortaleció su cartera de propiedad intelectual con una nueva patente en EE. UU. para sus sistemas de catéteres de administración de bioterapéuticos.
Los hitos próximos incluyen reuniones con la FDA sobre la aprobabilidad de CardiAMP HF en el Q4 2025, la revisión clínica por parte del PMDA en Japón y la presentación prevista a la FDA del sistema de administración bioterapéutica Helix en el Q3 2025.
BioCardia (NASDAQ:BCDA)는 2025년 2분기 재무실적과 심혈관 치료제 파이프라인의 주요 진전을 발표했습니다. 핵심 연구인 CardiAMP HF Trial은 2년 추적 결과에서 유망한 성과를 보였으며, 치료군에서 사망 및 합병증 발생률이 낮았고 NTproBNP가 높은 환자군에서 특히 유의미한 차이를 보였습니다 (p=0.02).
재무 하이라이트로는 2025년 2분기 연구개발비가 $1.4M로 증가했으며, 순손실은 $2.0M, 현재 현금 잔고는 약 $1.1M으로 2025년 10월까지의 운영 자금이 확보되어 있습니다. 또한 생물치료제 투여용 카테터 시스템에 대한 미국 신규 특허를 통해 지식재산 포트폴리오를 강화했습니다.
주요 향후 일정으로는 2025년 4분기 중 CardiAMP HF의 승인 가능성에 대한 FDA 회의, 일본 PMDA의 임상 심사, 그리고 2025년 3분기 예정인 Helix 생물치료제 전달 시스템에 대한 FDA 제출이 포함됩니다.
BioCardia (NASDAQ:BCDA) a publié ses résultats financiers du T2 2025 et fait état de progrès significatifs dans son portefeuille de thérapeutiques cardiovasculaires. L'essai principal, CardiAMP HF Trial, a livré des résultats prometteurs à deux ans : les groupes traités ont présenté une moindre incidence de décès et de complications, différence particulièrement significative chez les patients ayant un NTproBNP élevé (p=0.02).
Parmi les points financiers figurent une hausse des dépenses R&D à $1.4M au T2 2025, une perte nette de $2.0M et une trésorerie actuelle d'environ $1.1M, assurant une visibilité jusqu'en octobre 2025. La société a renforcé son portefeuille de propriété intellectuelle avec un nouveau brevet américain pour ses systèmes de cathéters destinés à l'administration de biothérapies.
Les jalons à venir incluent des réunions avec la FDA sur l'approvabilité de CardiAMP HF au T4 2025, l'examen clinique par le PMDA au Japon et le dépôt prévu auprès de la FDA du système d'administration biothérapeutique Helix au T3 2025.
BioCardia (NASDAQ:BCDA) veröffentlichte die Finanzergebnisse für das 2. Quartal 2025 und berichtet über erhebliche Fortschritte in seiner kardiovaskulären Wirkstoffpipeline. Die Flaggschiff-Studie, CardiAMP HF Trial, zeigte vielversprechende Zwei-Jahres-Ergebnisse: die behandelten Gruppen wiesen eine geringere Sterblichkeits- und Komplikationsrate auf, besonders ausgeprägt bei Patienten mit erhöhtem NTproBNP (p=0.02).
Zu den finanziellen Eckdaten zählen
Wichtige bevorstehende Meilensteine sind FDA-Gespräche zur Zulassungsfähigkeit von CardiAMP HF im Q4 2025, die klinische Prüfung durch die japanische PMDA sowie die geplante FDA-Einreichung für 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 – 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) -- BioCardia, Inc. [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’s formal remarks, there will be a question-and-answer session.
Recent Business Highlights
CardiAMP® 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’s 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’s 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’s 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 “Radial and Trans-endocardial Delivery Catheter.” The patent describes the Company’s 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’s helical needle-tipped catheter technology platform, which the scientific literature supports is the safest1 and most efficient2 approach for biotherapeutic delivery to the heart.
“Heart 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,” said BioCardia CEO Peter Altman, Ph.D. “Our 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.”
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 – Q4 2025
- CardiAMP HF Japan PMDA Clinical Review – Q4 2025
- CardiAMP HF FDA meetings on approvability based on subgroup and safety – Q4 2025
- CardiAMP HF II Enrollment – Ongoing
BCDA-02 CardiAMP Autologous Cell Therapy in Chronic Myocardial Ischemia
- CardiAMP CMI Top line Data Rollin Cohort – Q4 2025
BCDA-03 CardiALLO Allogeneic MSC Cell Therapy in Heart Failure
- CardiALLO HF Nondilutive Funding – Q1 2026
Helix Biotherapeutic Delivery System
- Helix biotherapeutic delivery FDA Submission for Approval – Q3 2025
About BioCardia
BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLOTM allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its HelixTM biotherapeutic delivery and Morph® 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: www.BioCardia.com.
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’s 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’s business and product development plans, the ability to enter into licensing and partnering arrangements and overall market conditions. 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 “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” 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’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.”
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.
| BIOCARDIA, INC. | ||||||||||||||||
| Consolidated Statements of Operations | ||||||||||||||||
| (Unaudited In thousands, except share and per share amounts) | ||||||||||||||||
| Three Months ended June 30, | Six Months ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue: | ||||||||||||||||
| Collaboration agreement revenue | $ | — | $ | 3 | $ | — | $ | 58 | ||||||||
| Costs and expenses: | ||||||||||||||||
| Research and development | 1,368 | 800 | 2,898 | 2,041 | ||||||||||||
| Selling, general and administrative | 683 | 852 | 1,879 | 1,941 | ||||||||||||
| Total costs and expenses | 2,051 | 1,652 | 4,777 | 3,982 | ||||||||||||
| Operating loss | (2,051 | ) | (1,649 | ) | (4,777 | ) | (3,924 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Total other income, net | 2 | 3 | 16 | 11 | ||||||||||||
| Net loss | $ | (2,049 | ) | $ | (1,646 | ) | $ | (4,761 | ) | $ | (3,913 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.40 | ) | $ | (0.88 | ) | $ | (0.98 | ) | $ | (2.20 | ) | ||||
| Weighted-average shares used in computing | ||||||||||||||||
| net loss per share, basic and diluted | 5,059,736 | 1,877,069 | 4,848,922 | 1,776,305 | ||||||||||||
| BioCardia, Inc. | ||||||
| Selected Balance Sheet Data | ||||||
| (amounts in thousands) | ||||||
| June 30, 2025(1) | December 31, 2024(1) | |||||
| Assets: | ||||||
| Cash and cash equivalents | $ | 980 | $ | 2,371 | ||
| Other current assets | 219 | 251 | ||||
| Property, plant and equipment and other noncurrent assets | 890 | 1,102 | ||||
| Total assets | $ | 2,089 | $ | 3,724 | ||
| Liabilities and Stockholders' Equity (Deficit) | ||||||
| Current liabilities | $ | 3,642 | $ | 2,321 | ||
| Operating lease liability - noncurrent | 333 | 566 | ||||
| Total stockholders' equity (deficit) | (1,886 | ) | 837 | |||
| Total liabilities and stockholders' equity (deficit) | $ | 2,089 | $ | 3,724 | ||
| (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. | ||||||
Media Contact:
Miranda Peto, Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120
Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120
FAQ
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