Core Insights - BioCardia, Inc. reported its financial results for Q2 2025, highlighting advancements in its cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases [1][6] Recent Business Highlights - The CardiAMP autologous cell therapy for ischemic heart failure (BCDA-01) demonstrated a 107-second increase in exercise tolerance and an 82% reduction in angina episodes at the six-month follow-up [2] - The CardiALLO allogeneic cell therapy (BCDA-03) is progressing with a Phase 1/2 trial, having completed a low dose cohort with no adverse events reported [2][4] - The CardiAMP HF Trial results indicated a lower incidence of all-cause death and non-fatal major adverse cardiovascular events (MACCE) compared to the control group [3] Financial Results - Research and development expenses rose to approximately $1.4 million for Q2 2025, up from $0.8 million in Q2 2024, primarily due to activities related to the CardiAMP HF Trial [8] - The net loss for Q2 2025 was approximately $2.0 million, compared to $1.6 million in Q2 2024, attributed to increased trial-related expenses [8][15] - Cash balance as of June 30, 2025, was approximately $980,000, with subsequent stock sales increasing the balance to approximately $1.1 million [8][16] Intellectual Property - BioCardia's patent portfolio was strengthened with the issuance of US patent No. 12,311,127 for a delivery catheter system, enhancing its capabilities in minimally invasive heart therapies [5] Anticipated Upcoming Milestones - The company plans to submit for approval of the Helix biotherapeutic delivery system in Q3 2025 and anticipates key meetings with regulatory agencies in Q4 2025 [9][13]

Core Insights - BioCardia, Inc. will provide a corporate update and report its financial results for Q2 2025 on August 11, 2025, at 4:30 PM ET [1] - The company specializes in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases [4] Company Overview - BioCardia is headquartered in Sunnyvale, California, and is recognized as a global leader in its field [4] - The company has developed two main biotherapeutic platforms: CardiAMP autologous and CardiALLO™ allogeneic cell therapies, with three clinical stage product candidates currently in development [4] - BioCardia's therapies are supported by its Helix biotherapeutic delivery and Morph vascular navigation product platforms [4] Conference Call Details - Participants can register for the conference call via a specific link and will receive their dial-in number upon registration [2] - For those not registered, U.S. callers can dial 1-833-316-0559, while international callers should use 1-412-317-5730, with a recommendation to join the call 10 minutes early [2] - A live webcast of the call will also be available through a provided link [2] Replay Information - A replay of the conference call will be accessible approximately one hour after its conclusion through the same links [3] - Telephonic replay options are available for domestic and international callers using specific access codes [3]

SUNNYVALE, Calif., Aug. 04, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today provides the anticipated timing of regulatory activities seeking FDA and Japan PMDA approvals of its CardiAMP® Cell Therapy System and Helix Transendocardial Delivery Catheter. Q3 2025 Helix application for approval to FDA The Company intends to submit for approval of the Helix Transendocardial Deliver ...

Core Insights - BioCardia, Inc. has submitted its CardiAMP autologous cell therapy for heart failure to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for clinical consultation, marking a significant step towards regulatory approval in Japan [1][4] Group 1: Regulatory Process - The PMDA consultation process is essential for new medical products in Japan, involving a detailed clinical data package that includes the full CardiAMP HF Trial data and Summary Technical Documentation (STED) [2] - The consultation will review clinical data from the CardiAMP HF trial, focusing on efficacy, safety, target patient populations, and the therapy's role in heart failure care in Japan [3] Group 2: Clinical Development - The CardiAMP therapy has received FDA Breakthrough designation and utilizes a patient's own bone marrow cells to treat microvascular dysfunction through a minimally invasive procedure [6] - The recently completed CardiAMP HF Trial demonstrated significant outcomes, including reduced all-cause death and improved quality of life in patients with elevated NTproBNP [6] Group 3: Future Prospects - Successful alignment with PMDA could lead to market entry approval for the CardiAMP system in Japan, with potential for a post-marketing study next year [4][5] - BioCardia is committed to advancing heart failure treatments and is exploring collaboration opportunities in Japan [5]

Core Viewpoint - BioCardia, Inc. is advancing its CardiAMP HF II trial for ischemic heart failure, enrolling patients at Henry Ford Health, aiming to confirm the efficacy of its autologous cell therapy [1][2][4] Company Overview - BioCardia, Inc. is a leader in cellular and cell-derived therapeutics focused on cardiovascular and pulmonary diseases, with its headquarters in Sunnyvale, California [9] - The company is developing two biotherapeutic platforms: CardiAMP autologous and CardiALLO™ allogeneic cell therapies, with three clinical stage product candidates [9] Clinical Trial Details - The CardiAMP HF II trial is a 250-patient randomized multicenter placebo-controlled study targeting patients with ischemic HFrEF on guideline-directed medical therapy [4] - The trial aims to confirm safety and efficacy results observed in the previous CardiAMP HF study, utilizing a three-tier composite primary outcome measure [4] - The investigational therapy involves harvesting patients' own bone marrow cells, which are processed and delivered during a minimally invasive procedure [2][4][6] Importance of the Trial - The CardiAMP HF cell therapy trials are crucial for patients with ischemic heart failure, providing potential new treatment options [2] - The therapy is designed to promote microvascular repair, reduce fibrosis, and increase capillary density, addressing mechanisms of microvascular dysfunction [6] Industry Context - Heart failure affects approximately 6.2 million adults in the U.S., with about 960,000 new cases diagnosed each year [5] - Current treatments for heart failure include lifestyle changes, medications, and surgical procedures, but many patients do not respond well or experience adverse effects [5]

Core Insights - BioCardia, Inc. has been granted US Patent No. 12,311,127 for its "Radial and Trans-endocardial Delivery Catheter" technology, which focuses on minimally invasive interventional catheter systems for delivering biologic therapies to the heart [1][2]. Company Overview - BioCardia is a leader in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases, with its headquarters in Sunnyvale, California [4]. - The company is developing two main biotherapeutic platforms: CardiAMP autologous and CardiALLO™ allogeneic cell therapies, with three clinical stage product candidates currently in development [4]. Technology and Innovation - The patented helical needle-tipped catheter technology is designed to provide optimal, site-specific treatment while minimizing off-target toxicities and avoiding surgical access to the heart [2]. - The Helix catheter system is integral to the safety and efficacy of the CardiAMP Cell Therapy development program, which aims to improve outcomes for patients with ischemic cardiomyopathies and refractory angina [3]. Future Developments - BioCardia is actively pursuing separate approvals for both the CardiAMP Cell Therapy and the Helix biotherapeutic delivery system, which is expected to facilitate a smooth transition from research to commercialization [3].

Summary of Biocardia (BCDA) FY Conference Call Company Overview - Biocardia is a late-stage development company focused on autologous stem cell therapy for ischemic heart failure and chronic myocardial ischemia, located in Sunnyvale, California [1][2][5] - The company has four clinical programs at various stages of advancement [5] Core Points and Arguments Heart Failure Program - The lead indication is heart failure, specifically the BCDA DAO one cardiac phase three trial [6] - Heart failure is described as an enormous unmet medical need, with the therapy aiming to treat microvascular dysfunction by delivering high dosages of autologous cells directly into the heart muscle [6][7] - Preclinical models have shown that the therapy can reduce fibrosis and enhance capillary density [7] - The therapy includes a selection diagnostic to screen out patients who are not appropriate for treatment [7][8] Clinical Trial Data - In March, data from the heart failure one trial was presented, showing reduced mortality and improved quality of life, despite not hitting the primary endpoint [10][11] - The trial involved 115 patients and demonstrated statistical significance in secondary endpoints, including survival and reduction in major adverse cardiac events [11][12] - A one-time dosage of cells is administered, with a two-year follow-up showing robust effects [12] Upcoming Trials and Regulatory Submissions - The FDA approved a subsequent trial (Heart Failure II) to address previous enrollment challenges, with modifications to the study design [14][15] - The new trial will focus on patients with elevated markers of heart stress and aims to double the enrollment rate [19] - Biocardia is pursuing expedited approval from Japan's PMDA for cardiac cell therapy, with a submission expected within the year [21][24] - The company is also working on FDA submissions for its delivery system, which has shown excellent safety data [25] Chronic Myocardial Ischemia Program - The CardiAmp CMI program targets chronic myocardial ischemia with refractory angina, a condition poorly met by existing therapies [26][28] - There are at least one million patients in the U.S. with this condition, and Biocardia's approach aims to be the least expensive cardiac cell therapy available [30][31] - The company is working on a manuscript for early data from the low dose cohort of the CMI trial [32] Other Important Information - Biocardia has an allogeneic platform and is exploring partnerships for both cardiac and pulmonary indications [38][40] - The partnership environment is currently challenging due to market stability concerns, but Biocardia's assets are proven and in the clinic [41] - The company is focused on advancing its lead program while also exploring opportunities in other areas [39][41]

Core Insights - BioCardia, Inc. is focused on developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases [1] - The CEO, Dr. Peter Altman, will discuss recent developments in the company's therapeutic pipeline, particularly the CardiAMP autologous cell therapy for ischemic heart failure [2] Event Details - The fireside chat is scheduled for May 21, 2025, at 03:40 p.m. EDT, moderated by Jim Molloy from Alliance Global Partners [3] - The event will be available via webcast [3] Company Overview - BioCardia is headquartered in Sunnyvale, California, and is recognized as a leader in cellular and cell-derived therapeutics [3] - The company has two main biotherapeutic platforms: CardiAMP autologous and CardiALLO™ allogeneic cell therapies, with three cardiac clinical stage product candidates in development [3] - BioCardia's therapies utilize the Helix™ biotherapeutic delivery and Morph vascular navigation product platforms [3]

Financial Data and Key Metrics Changes - Total expenses increased by $396,000 quarter over quarter to $2,700,000 in Q1 2025 compared to $2,300,000 in Q1 2024 [15] - Research and development expenses rose by $289,000 to $1,500,000 in Q1 2025 from $1,200,000 in Q1 2024 [15] - Net loss was $2,700,000 in Q1 2025 compared to $2,300,000 in Q1 2024 [16] - Net cash used in operations was $1,600,000 for Q1 2025, comparable to $1,500,000 in Q1 2024 [17] Business Line Data and Key Metrics Changes - The CARDI Amp heart failure trial demonstrated safety and meaningful benefits for heart failure patients [6] - The CardioM Heart Failure II trial is actively enrolling patients at three clinical sites, with expectations for full enrollment over the next two years [7] - The Helix biotherapeutics delivery system is preparing for submission for approval, with potential value for therapeutic partners [9] Market Data and Key Metrics Changes - The electrophysiology market is valued at over $10 billion per year and is expanding to treat arrhythmias in the ventricles of the heart [12] - The company is focused on the Japanese market, with expectations for regulatory approval processes similar to the FDA [30] Company Strategy and Development Direction - The company aims to align with the FDA and Japan's PMDA to make CARDI Amp therapy available to physicians and patients [6] - Business development efforts are focused on partnerships that enhance shareholder value across all four platforms: CardiAmp, Cardiallo, Helix, and MorphDNA [10] - The company is open to partnerships in various indications not currently pursued, particularly in the allogeneic cell therapy space [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety and efficacy of their therapies, emphasizing the importance of generating additional clinical evidence [40] - The company is optimistic about the potential for significant market opportunities in Japan, particularly with the CARDI Amp therapy [35] - Management noted that they are not significantly impacted by tariffs due to the domestic manufacturing of most components [49] Other Important Information - The company completed a small financing with minimal dilution to support upcoming milestones [14] - Management highlighted the importance of physician outreach and training for the introduction of new therapies into commercial channels [32] Q&A Session Summary Question: Discussion on business development maturity levels - Management indicated that while deal discussions can be lengthy, they have established products and ongoing discussions with large strategic partners [20] Question: Importance of Japan PMDA submission for CARDI Amp - Management confirmed that receiving permission to submit for approval in Japan is critical and aligns with their strategy for market entry [30] Question: Interaction between ongoing trials and FDA submission - Management clarified that they are continuously developing evidence while submitting for FDA approval, focusing on patient enrollment and data generation [40]

Financial Data and Key Metrics Changes - Total expenses increased by $396,000 quarter over quarter to $2,700,000 in Q1 2025 compared to $2,300,000 in Q1 2024 [14] - Research and development expenses rose by $289,000 to $1,500,000 in Q1 2025 from $1,200,000 in Q1 2024, driven by costs related to the cardiac heart failure trial [15] - Net loss was $2,700,000 in Q1 2025 compared to $2,300,000 in Q1 2024 [16] Business Line Data and Key Metrics Changes - The CARDI Amp heart failure trial results showed safety and meaningful benefits for heart failure patients, with a focus on sharing data with regulatory agencies [5] - The CardioM Heart Failure II trial is actively enrolling patients at three clinical sites, with expectations for full enrollment over the next two years [6] - The Helix biotherapeutics delivery system is preparing for submission for approval, with potential value for therapeutic partners [7] Market Data and Key Metrics Changes - The electrophysiology market, valued at over $10 billion annually, is expanding to treat arrhythmias in the ventricles of the heart, where the company delivers cell therapies [11] - The company is focused on the Japanese market, with ongoing discussions with regulators and potential distributors for the CARDI Amp cell therapy [25] Company Strategy and Development Direction - The company aims to align with the FDA and Japan's PMDA to make the CARDI Amp therapy available to physicians and patients [5] - The strategy includes enhancing partnerships across all four platforms: CardiAmp, Cardiallo, Helix, and MorphDNA, to create value for shareholders [10] - The company is focused on minimizing operational costs and enhancing enrollment through partnerships and innovative delivery systems [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the approval process in Japan, anticipating a six-month timeframe for clarity on submission [30] - The company believes that its extensive clinical data will help close the valuation gap with peers in Japan [33] - Management highlighted the importance of ongoing clinical trials to develop further evidence for their therapies [38] Other Important Information - The company completed a small financing with minimal dilution to support upcoming milestones [13] - The company maintains a low burn rate, providing flexibility in funding value creation [16] Q&A Session Summary Question: Discussion on business development maturity - Management emphasized the importance of established products and ongoing discussions with large strategic partners [20] Question: Importance of Japan's PMDA submission - Management confirmed that PMDA's acceptance for submission is akin to FDA's acceptance of a BLA, which is critical for market entry [28] Question: Interaction between ongoing trials and FDA submission - Management clarified that they are developing additional evidence while submitting for FDA approval, focusing on patient enrollment and trial design improvements [39]