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. is conducting a pivotal Phase 3 trial, CardiAMP HF II, to evaluate the CardiAMP™ cell therapy for patients with ischemic heart failure of reduced ejection fraction (HFrEF) and elevated cardiac stress markers [1][3] - The trial aims to demonstrate that the cell therapy can significantly improve survival and quality of life for heart failure patients, particularly those with elevated NTproBNP levels [2][3] Company Overview - BioCardia, Inc. is a leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with its headquarters in Sunnyvale, California [7] - The company has two main biotherapeutic platforms: CardiAMP® autologous and CardiALLO™ allogeneic cell therapies, and is developing three clinical stage product candidates [7] Clinical Study Details - The CardiAMP HF II study will enroll 250 patients and is a randomized, multicenter, placebo-controlled trial focusing on the safety and efficacy of the CardiAMP autologous cell therapy [3] - The primary outcome measures include all-cause death, nonfatal major adverse cardiac events, and a validated quality of life assessment [3] Therapeutic Approach - CardiAMP cell therapy utilizes a patient's own bone marrow cells delivered via a minimally invasive procedure to enhance the body's natural healing response [5] - The therapy targets mechanisms leading to microvascular dysfunction, including fibrotic, inflammatory, apoptotic, and endothelial dysfunction [5] Regulatory and Financial Support - The CardiAMP clinical development is supported by the Maryland Stem Cell Research Fund and is reimbursed by the Centers for Medicare and Medicaid Services (CMS) [6]

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].

Core Insights - The Independent Data Safety Monitoring Board (DSMB) has recommended that the CardiALLO-HF trial proceed as planned based on a 30-day safety assessment of participants treated with a low dosage of 20 million cells [1][2] - BioCardia, Inc. is advancing its allogeneic mesenchymal stromal/stem cell therapy, which has potential implications for funding and partnerships [3] Company Overview - BioCardia, Inc. is a leader in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases, with its headquarters in Sunnyvale, California [5] - The company has two main biotherapeutic platforms: CardiAMP® (autologous) and CardiALLO™ (allogeneic), with three clinical stage product candidates currently in development [5] Trial Details - The CardiALLO Heart Failure Trial is a Phase I/II study that includes a nine-patient dose escalation cohort followed by a thirty-patient randomized double-blinded placebo-controlled cohort [4] - The trial will evaluate three escalating doses of 20 million, 100 million, and 200 million cells, utilizing the Helix minimally invasive delivery system [4] Clinical Significance - Previous clinical results from the TRIDENT trial indicated that higher dosages of MSC reduced myocardial scar and improved left ventricular ejection fraction [3] - The CardiALLO HF trial is expected to target patients with active inflammation and aims to use at least twice the effective dosage compared to previous studies [3]

Core Insights - BioCardia, Inc. is conducting a pivotal Phase III trial, CardiAMP HF II, to evaluate the CardiAMP™ Cell Therapy for patients with ischemic heart failure of reduced ejection fraction [1][2] - Emory University School of Medicine has joined the trial, which aims to enhance microvascular density and reduce fibrosis through autologous mononuclear cell delivery [2][3] - The CardiAMP cell therapy has shown promising results in previous trials, indicating potential benefits for patients with heart failure [3][7] 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 [9] - The company utilizes proprietary delivery systems and pre-procedural cell analysis to enhance the efficacy and safety of its therapies [5][9] Clinical Development - The CardiAMP HF II trial is expected to accelerate patient enrollment, with a target completion date set for 2027 [3][8] - Previous studies have shown statistically significant improvements in survival and quality of life for patients treated with CardiAMP therapy [7] Market Context - Heart failure of reduced ejection fraction (HFrEF) affects approximately 3 million American adults, with projections indicating an increase to over 4 million by 2030 [4] - Existing therapies often fail to manage advanced heart failure symptoms effectively, highlighting the need for innovative treatments like CardiAMP [4][5]

Financial Data and Key Metrics Changes - Total expenses decreased by 35% year-over-year to $8.1 million in 2024 from $12.1 million in 2023, primarily driven by a 43% reduction in research and development expenses to $4.4 million from $7.7 million [35][36] - Net loss decreased to $7.9 million in 2024, down from $11.6 million in 2023, with net cash used in operations approximately $8 million, a 20% decrease from $10 million in 2023 [37][38] - The company ended the year with cash and cash equivalents totaling $2.4 million, with expectations of a moderate increase in cash burn in 2025 [38] Business Line Data and Key Metrics Changes - The CARDI-AMP Heart Failure Trial showed a 47% relative risk reduction in heart death equivalents and a 16% relative risk reduction in major adverse cardiac events, with a clinically meaningful 10.5% improvement in quality of life score [14][19] - The trial did not meet its primary endpoint due to the six-minute walk distance test, but showed strong results in other key areas [12][19] Market Data and Key Metrics Changes - The market reaction to the trial results was surprising, as the data was in line with expectations, indicating a strong need for therapies in ischemic heart failure [18][22] - The FDA granted cardiac cell therapy a breakthrough device designation, highlighting the significant unmet clinical need in this area [22][24] Company Strategy and Development Direction - The company is focused on advancing its cardiac cell therapy programs, with plans to share two-year data with the FDA and Japan's PMDA to align on pathways for making therapies available [21][22] - Ongoing discussions with regulatory agencies aim to ensure the safety and efficacy of cardiac cell therapy, with a focus on the unique benefits of the therapy compared to traditional medical devices [24][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strength of the data from the CARDI-AMP trial and its implications for future trials, particularly the CAR-DMHF2 trial [20][21] - The company anticipates modest increases in R&D expenses in 2025 as it continues to advance therapeutic candidates [36] Other Important Information - The company completed enrollment in the low-dose cohort of its cardi-allo-allogeneic mesenchymal stem cell therapy in ischemic heart failure [26] - The Helix biotherapeutic delivery platform is expected to enhance commercialization and clinical development efficiency [31][32] Q&A Session Summary Question: Can you provide more details on PMDA discussions in Japan? - Management met with PMDA in November and is preparing to share two-year data, which looks promising, potentially leading to conditional approval in Japan [42][43] Question: Were there any subsequent therapies that could have impacted the data read? - All patients were on guideline-directed medical therapy, and no other medications were introduced during the trial [46][48] Question: What is the expected timeline for sharing two-year data with the FDA? - The company is preparing a submission package and expects to request a consultation with the FDA soon, with timelines potentially ranging from three to eight weeks [78][80] Question: How does the data from the Heart Failure 1 trial inform the Heart Failure 2 trial? - The primary endpoint structure remains the same, and the company aims to replicate the positive outcomes seen in the first trial [88][90] Question: What are the next steps with the PMDA? - The company is finalizing the submission package and scheduling the next consultation with PMDA, aiming for a thorough and detailed presentation [78][82]

Financial Data and Key Metrics Changes - Total expenses decreased by 35% year-over-year to $8.1 million in 2024 from $12.1 million in 2023, primarily driven by a 43% reduction in research and development expenses to $4.4 million from $7.7 million [35][36] - Net loss decreased to $7.9 million in 2024, down from $11.6 million in 2023, and net cash used in operations was approximately $8 million, a 20% decrease from approximately $10 million in 2023 [37][38] - The company ended the year with cash and cash equivalents totaling $2.4 million, with expectations of a moderate increase in cash burn in 2025 [38] Business Line Data and Key Metrics Changes - The CARDI-AMP Heart Failure Trial data showed a 47% relative risk reduction in heart death equivalents and a 16% relative risk reduction in major adverse cardiac events [14][19] - Quality of life improvements were noted with a 10.5% point increase in quality of life scores and a 13.9-meter improvement in the six-minute walk distance test [14][15] Market Data and Key Metrics Changes - The market reaction to the trial results was unexpected, as the data was aligned with previous expectations despite not meeting the primary endpoint [18][19] - The company anticipates that the compelling data will enhance interest from distribution partners and strategics, particularly in the context of increasing attention on interventional therapies for heart failure [29] Company Strategy and Development Direction - The company is focused on advancing its lead therapeutic candidate, autologous cardiac cell therapy, and plans to share two-year data with regulatory authorities to align on pathways for making the therapy available [21][24] - Ongoing discussions with regulatory agencies aim to highlight the safety and efficacy of cardiac cell therapy, emphasizing the lack of long-term safety issues compared to traditional therapies [23][24] - The company is also progressing in other therapeutic programs, including the Cardi-AMP Cell Therapy and Chronic Myocardial Ischemia Trial [26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the strength of the two-year data and its potential impact on future trials and regulatory discussions [43][70] - The company is preparing a submission package for the PMDA in Japan, with expectations for a consultation meeting soon [78][82] - Management acknowledged the need for continued engagement with regulatory authorities to ensure a smooth approval process [81] Other Important Information - The company has completed enrollment in the low-dose cohort of its cardi-allo-allogeneic mesenchymal stem cell therapy in ischemic heart failure [26] - The Helix biotherapeutic delivery platform is expected to enhance future commercialization and clinical development efficiency [31][32] Q&A Session Summary Question: Can you provide more details on PMDA discussions in Japan? - Management met with PMDA in November and is preparing to share two-year data, which looks promising for potential conditional approval in Japan [42][43] Question: Were there any subsequent therapies that could have impacted the data read? - All patients were on guideline-directed medical therapy, and no other medications were introduced during the trial [47][50] Question: What is the expected timeline for sharing two-year data with the FDA? - The company is compiling the data for submission and expects to have a meeting with the FDA soon, with a timeline potentially as short as three weeks [70][82] Question: How does the data from Heart Failure 1 inform Heart Failure 2 trials? - The primary endpoint structure remains the same, and the company aims to replicate the positive outcomes observed in the first trial [88] Question: What are the next steps regarding interactions with the PMDA? - The company is preparing a submission package and scheduling a consultation meeting with the PMDA, with expectations for a timeline of three to eight weeks [78][82]

Core Viewpoint - BioCardia, Inc. will discuss the two-year CardiAMP-HF results in a conference call scheduled for March 31, 2025, at 4:30 PM EDT, correcting an earlier error regarding the time [1]. Group 1 - The conference call will provide insights into the two-year results of CardiAMP-HF, a key therapeutic for cardiovascular diseases [1]. - Participants can register for the conference call through a specific link and will receive their dial-in number upon registration [2]. - For those who have not registered, U.S. callers can dial 1-833-316-0559, while international callers should use 1-412-317-5730 to join the call [2]. Group 2 - A live webcast of the conference call will be available, and the link for access is provided [2]. - A replay of the call will be accessible approximately one hour after its conclusion, with specific links for international access [3]. - Telephonic replay options are available for domestic and international callers, with an access code provided for entry [3].

Core Viewpoint - BioCardia, Inc. will discuss the two-year CardiAMP-HF results in a conference call scheduled for March 31, 2025, at 4:30 PM EDT, correcting an earlier error regarding the time [1]. Group 1 - The conference call is intended to provide insights into the two-year results of CardiAMP-HF, a therapeutic for cardiovascular diseases [1]. - The press release mistakenly stated the call time as 4:30 PM PDT instead of EDT [1]. Group 2 - Participants can register for the conference call through a specific link and will receive their dial-in number upon registration [2]. - U.S. callers can join the call by dialing 1-833-316-0559, while international callers should use 1-412-317-5730 [2]. - A live webcast of the call will also be available through a provided link [2]. Group 3 - A replay of the conference call will be accessible approximately one hour after its conclusion [3]. - International access to the replay can be obtained through a designated link [3]. - A telephonic replay is available by calling specific numbers for domestic and international participants, using an access code [3]. Group 4 - Media and investor contacts for BioCardia include Miranda Peto for marketing and investor relations, and David McClung as the Chief Financial Officer [4].

Core Insights - BioCardia, Inc. announced two-year outcomes from the Phase 3 CardiAMP-HF study, demonstrating the efficacy of CardiAMP autologous cell therapy for ischemic heart failure patients with reduced ejection fraction [1][2][3] Group 1: Clinical Trial Results - The CardiAMP-HF Trial involved 115 ischemic heart failure patients across 18 centers in the U.S. and Canada, showing that patients receiving CardiAMP therapy alongside medication experienced decreased mortality and major adverse cardiac and cerebrovascular events (MACCE) [2][4] - Statistically significant improvements were observed in patients with elevated NTproBNP, indicating greater benefits for those under active heart stress [4][5] - Treated patients exhibited a 13% reduction in heart death equivalents and a 47% relative risk reduction in heart death equivalents compared to those on medication alone [5] Group 2: Quality of Life Improvements - Patients receiving CardiAMP therapy reported a clinically meaningful 10.5-point improvement in quality of life, as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) [5] - Improvements in physical capacity were noted, with a 13.9-meter increase in Six Minute Walk Distance for treated patients [5] Group 3: Mechanism and Market Potential - CardiAMP Cell Therapy is designated as a Breakthrough Therapy by the FDA, utilizing a pre-procedural cell analysis, a high target dosage of cells, and a minimally invasive delivery system [3][6] - The therapy targets mechanisms leading to microvascular dysfunction, potentially benefiting around one million patients in the U.S. who currently incur $30 billion annually in healthcare costs [7][8] Group 4: Future Directions - BioCardia plans to share the two-year data with the U.S. FDA and Japan PMDA to expedite the therapy's availability for patients [7] - The company emphasizes the potential of CardiAMP therapy to reduce healthcare costs associated with heart failure by improving patient health outcomes [7]