Financial Performance - BioCardia reported a net loss of approximately $2.7 million for Q1 2025, compared to a net loss of approximately $2.3 million for Q1 2024, reflecting a 17.4% increase in losses year-over-year[9] - BioCardia's cash and cash equivalents decreased to $949,000 as of March 31, 2025, down from $2.37 million at the end of 2024[16] - Total liabilities increased to $3.23 million as of March 31, 2025, compared to $2.32 million at the end of 2024, indicating a rise in financial obligations[16] Research and Development - Research and development expenses were approximately $1.5 million for Q1 2025, up from approximately $1.2 million in Q1 2024, primarily due to activities related to the CardiAMP HF Trial[9] - The CardiAMP autologous cell therapy demonstrated an average 107-second increase in exercise tolerance and an 82% average reduction in angina episodes at the six-month follow-up[2] - The two-year results from the CardiAMP HF Trial showed statistically significant improvements in survival and reduced cardiovascular events, with a p-value of 0.02 in the subset of patients with elevated NTproBNP[3] - The CardiALLO cell therapy trial completed its low dose cohort of 20 million cells with no adverse events reported, and the study is set to progress to 39 participants in the U.S.[4] Regulatory and Intellectual Property - The Helix biotherapeutic delivery system had no procedure-related deaths or complications in the recent CardiAMP HF Trial, supporting the ongoing FDA approval submission[5] - The company holds a robust intellectual property portfolio with over 60 patents and applications worldwide, including a recently granted patent in Japan[6][7] - Upcoming milestones include regulatory submissions for the CardiAMP Cell Therapy System and the Helix delivery system, anticipated within the current quarter[8]

Financial Performance - The company reported a net loss of $2.712 million for the three months ended March 31, 2025, compared to a net loss of $2.267 million for the same period in 2024, indicating an increase in losses of about 20%[17] - The accumulated deficit increased to approximately $162.8 million as of March 31, 2025, compared to $160.1 million at the end of 2024[14] - The company anticipates that operating losses and negative cash flows will continue for several years, raising substantial doubt about its ability to continue as a going concern beyond July 2025[32] Assets and Liabilities - As of March 31, 2025, total assets decreased to $2.166 billion from $3.724 billion as of December 31, 2024, representing a decline of approximately 42%[14] - Total current liabilities increased to $3.234 million as of March 31, 2025, compared to $2.321 million at the end of 2024, an increase of approximately 39%[14] - Cash and cash equivalents decreased to $949,000 as of March 31, 2025, down from $2.371 million at the end of 2024, a reduction of about 60%[14] - As of March 31, 2025, approximately 98% of the company's cash and cash equivalents, totaling $684,000, were held by one financial institution, exceeding the FDIC insurance limit of $250,000 per customer[36] - Accrued expenses and other current liabilities increased from $1,551,000 as of December 31, 2024, to $2,018,000 as of March 31, 2025[49] Research and Development - Research and development expenses rose to $1.530 million in Q1 2025, up from $1.241 million in Q1 2024, reflecting a year-over-year increase of approximately 23%[17] - BioCardia is focused on developing cell therapy systems for cardiovascular and pulmonary diseases, with ongoing pivotal trials for ischemic heart failure and refractory angina[26] Capital and Financing - The company plans to raise additional capital to fund future operations, which may include debt and equity arrangements[33] - The company sold 81,274 shares under the ATM offerings for total gross proceeds of $212,000 during the three months ended March 31, 2025[55] - The gross proceeds from a private placement on April 23, 2025, amounted to $775,000, with warrants exercisable at $1.905 per share[62] Expenses - Share-based compensation expense for the three months ended March 31, 2025, was $170,000, down from $204,000 in the same period of 2024[56] - The company reported a depreciation expense of $12,000 for the three months ended March 31, 2025, compared to $19,000 for the same period in 2024[44] - The total operating lease liabilities as of March 31, 2025, were $850,000, with future minimum lease payments totaling $932,000[48] Market Risk - The company's exposure to market risk is currently limited to cash and cash equivalents with maturities of less than three months[113] - A hypothetical 100 basis point increase or decrease in interest rates would have an immaterial pre-tax impact on the company's results of operations as of March 31, 2025[114] - The majority of the company's revenues are derived from sales in the United States, indicating limited foreign currency exchange risk exposure[115] - The company does not currently engage in hedging to mitigate foreign currency risks but will continue to monitor and evaluate its processes[115]

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. 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]