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]

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. 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]

Core Insights - BioCardia, Inc. reported financial results for Q1 2025, highlighting advancements in its cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases [1][8] Recent Business Highlights - The CardiAMP autologous cell therapy for ischemic heart failure (BCDA-01) showed a 107-second increase in exercise tolerance and an 82% reduction in angina episodes at the six-month follow-up [2] - The CardiALLO cell therapy (BCDA-03) completed a low dose cohort with no adverse events, and the independent Data Safety Monitoring Board recommended proceeding with the study [3] - The Helix biotherapeutic delivery system demonstrated safety in the CardiAMP HF Trial, with no procedure-related deaths or complications, supporting FDA approval efforts [3] Intellectual Property - BioCardia holds over 60 patents and applications globally, with a recent patent granted in Japan for a delivery catheter that enhances minimally invasive treatment options [5][6] Financial Results - Research and development expenses increased to approximately $1.5 million in Q1 2025 from $1.2 million in Q1 2024, while selling, general, and administrative expenses rose to approximately $1.2 million from $1.1 million [11] - The net loss for Q1 2025 was approximately $2.7 million, compared to $2.3 million in Q1 2024, with net cash used in operations at approximately $1.6 million [11][15] Upcoming Milestones - The company plans to submit data to the FDA and Japan PMDA regarding the CardiAMP cell therapy and Helix delivery system, with additional enrollment in the CardiAMP HF II Trial [9][11]

Core Viewpoint - BioCardia, Inc. will provide a corporate update and report its financial results for Q1 2025 on May 14, 2025, at 4:30 PM EDT, followed by a Q&A session [1]. Group 1: Corporate Update - The conference call will include management's formal remarks and a question-and-answer session [1]. - Participants can register for the conference through a provided link [2]. Group 2: Call Details - Registered participants will receive their dial-in number upon registration, with specific numbers for U.S. and international callers [3]. - The conference call will also be available via a live webcast [3]. Group 3: Replay Information - A webcast replay will be available approximately one hour after the call until May 28, 2025 [4]. - A telephonic replay can be accessed using specific numbers and an access code [4]. Group 4: Company Overview - BioCardia, Inc. is a leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with three cardiac clinical stage product candidates [5]. - The company utilizes its Helix™ biotherapeutic delivery and Morph vascular navigation product platforms for its therapies [5].

Core Insights - BioCardia, Inc. has initiated the Phase III CardiAMP HF II clinical trial for its autologous cell therapy aimed at treating heart failure, with the first patient enrolled at BayCare Morton Plant Hospital in Clearwater, Florida [1][2]. Company Overview - BioCardia is a leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with its CardiAMP and CardiALLO cell therapies in clinical development [7]. Clinical Trial Details - The CardiAMP HF II study is a 250-patient randomized multicenter trial designed to confirm the safety and efficacy of the CardiAMP autologous cell therapy in patients with ischemic heart failure and reduced ejection fraction (HFrEF) [3]. - The trial aims to replicate the statistically significant composite efficacy endpoint achieved in the previous CardiAMP HF study, focusing on patients with elevated NTproBNP (p=0.02) [3]. Therapeutic Approach - CardiAMP cell therapy utilizes a patient's own bone marrow cells delivered via a minimally invasive procedure to stimulate natural healing, targeting mechanisms of microvascular dysfunction [5]. - The therapy has received FDA Breakthrough designation and is supported by the Maryland Stem Cell Research Fund, with reimbursement from the Centers for Medicare and Medicaid Services (CMS) [6]. Technological Advancements - The CardiAMP HF II trial incorporates cell population analysis for dose definition, enhancing patient eligibility, and features improvements to the Helix delivery system, including the FDA-approved Morph DNA steerable platform [4].