Financial Data and Key Metrics Changes - Research and development expenses increased to approximately $1,400,000 for Q2 2025 from approximately $800,000 in Q2 2024, and increased to approximately $2,900,000 for the six months ended June 2025 from $2,800,000 in the same period of 2024 [16] - Selling, general and administrative expenses decreased to approximately $700,000 in Q2 2025 from approximately $900,000 in Q2 2024, while remaining consistent at approximately $1,900,000 for the six months ended June 2025 compared to the same period in 2024 [16] - Net loss was approximately $2,000,000 for Q2 2025 compared to approximately $1,600,000 for Q2 2024, and approximately $4,800,000 for the six months ended June 2025 compared to approximately $3,900,000 for the same period in 2024 [17] - Cash and cash equivalents totaled $980,000 at the end of the quarter, with a current cash balance of approximately $1,100,000 after selling $769,000 in common stock [18] Business Line Data and Key Metrics Changes - The CardioAmp heart failure trial showed a lower incidence of all-cause death and non-fatal MACE in the treatment group compared to the control group, with a p-value of 0.17, and a statistically significant composite endpoint in patients with elevated NT proBNP with a p-value of 0.02 [6][9] - The CARDI Amp cell therapy in chronic myocardial ischemia (BCDO2) is expected to deliver final top-line data in Q4 2025 [14] - The Helix Biotherapeutic delivery system is anticipated to be submitted for FDA approval in Q3 2025 [15] Market Data and Key Metrics Changes - Japan's PMDA has shown interest in heart failure therapy, with the company expecting to align on pathways for therapy availability [7] - The company is preparing for a meeting with the FDA regarding the approvability of the CardiAmp system based on clinical data [9] Company Strategy and Development Direction - The company aims to partner its Helix delivery system for the cardiac electrophysiology market and is focused on creating value through partnerships across its four platforms: CardiAmp, CardiAllo, Helix, and MorphDNA [11][12] - The company is actively pursuing distribution partnerships in Japan and the U.S. for its therapies, emphasizing the cultural alignment of its autologous cell therapy with Japanese preferences [23][40] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the upcoming regulatory meetings with PMDA and FDA, highlighting the potential for approval based on compelling clinical data [35] - The company is focused on maintaining a low burn rate while advancing multiple trials and regulatory submissions, with an annual burn rate of approximately $6,000,000 [76] Other Important Information - The company is preparing a peer-reviewed manuscript based on the data presented at the American College of Cardiology, which will be accessible to the public [70] - The company is working on a financing event that aims to be beneficial for current shareholders, with a focus on minimizing dilution [73] Q&A Session Summary Question: Expectations regarding PMDA reviewing Cardium for heart failure as a medical device - Management indicated that the approval process is viewed as a lower hurdle for medical device approval, with a focus on the clinical consultation process [20][21] Question: Timing for the Cardium CMI program data - Management confirmed that the rolling cohort data related to primary endpoint results is expected in Q4 [26] Question: Timing of regulatory meetings and potential outcomes - If meetings go well, the approval process could take up to a year, with parallel efforts on reimbursement and distribution partnerships [32][34] Question: Status of FDA meeting type and HF2 trial screening - Management is contemplating the type of FDA meeting and confirmed that the HF2 trial is actively enrolling patients with a focus on compliance and stability [45][50] Question: Expectations following data readout for BCDA - Management stated that outcomes depend on PMDA and FDA responses, with potential for non-dilutive capital to accelerate the BCDA program [60] Question: Release of new data observations to the public - Management confirmed that a peer-reviewed manuscript will be prepared to share data observations, while also working on regulatory submissions [70] Question: Details on the upcoming financing event - Management emphasized the importance of a financing event that minimizes dilution and supports ongoing trials and partnerships [73][75]

[Part I. FINANCIAL INFORMATION](index=5&type=section&id=Part%20I.%20FINANCIAL%20INFORMATION) [Unaudited Condensed Consolidated Financial Statements](index=5&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The company reported a net loss of **$4.8 million** for the first half of 2025, with **$980,000** in cash and a **$164.9 million** accumulated deficit, raising substantial doubt about its going concern ability [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$2.1 million** by June 30, 2025, from **$3.7 million** at year-end 2024, while total liabilities increased to **$4.0 million**, resulting in a **$1.9 million** stockholders' deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $980 | $2,371 | | Total current assets | $1,199 | $2,622 | | Total assets | $2,089 | $3,724 | | **Liabilities & Equity** | | | | Total current liabilities | $3,642 | $2,321 | | Total liabilities | $3,975 | $2,887 | | Total stockholders' equity (deficit) | $(1,886) | $837 | | Total liabilities and stockholders' equity (deficit) | $2,089 | $3,724 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net losses increased to **$2.0 million** for Q2 2025 and **$4.8 million** for the first half of 2025, primarily due to higher research and development expenses and zero collaboration revenue Statement of Operations Summary (in thousands) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration agreement revenue | $0 | $3 | $0 | $58 | | Research and development | $1,368 | $800 | $2,898 | $2,041 | | Selling, general and administrative | $683 | $852 | $1,879 | $1,941 | | Operating loss | $(2,051) | $(1,649) | $(4,777) | $(3,924) | | 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) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$3.3 million** for the first half of 2025, while financing activities provided **$1.9 million**, resulting in a **$1.4 million** decrease in cash, ending at **$980,000** Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(3,267) | $(2,842) | | Net cash used in investing activities | $(1) | $(3) | | Net cash provided by financing activities | $1,877 | $3,163 | | **Net change in cash and cash equivalents** | **$(1,391)** | **$318** | | Cash and cash equivalents at end of period | $980 | $1,421 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes reveal substantial doubt about the company's going concern ability, with **$980,000** cash insufficient beyond October 2025, necessitating ongoing capital raises through private placements and ATM offerings - The company is a clinical-stage entity focused on cellular therapeutics for cardiovascular and pulmonary diseases, with its CardiAMP® and allogeneic MSC platforms in clinical trials[23](index=23&type=chunk) - Management states that cash and cash equivalents of **$980,000** as of June 30, 2025, are insufficient to fund planned expenditures beyond October 2025, raising substantial doubt about the company's ability to continue as a going concern[29](index=29&type=chunk) - In the first half of 2025, the company raised gross proceeds of **$775,000** in April and **$570,000** in June through private placements of common stock and warrants[51](index=51&type=chunk)[53](index=53&type=chunk) - Subsequent to the quarter end, between July 1 and August 8, 2025, the company sold 296,422 shares of common stock under its ATM offering for gross proceeds of **$769,000**[65](index=65&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses advancing clinical-stage cell therapy programs, noting increased R&D expenses and a higher net loss for H1 2025, with critically low liquidity and substantial doubt about going concern without further capital - The company is advancing its CardiAMP® autologous cell therapy platform in pivotal trials for ischemic heart failure (HFrEF) and chronic myocardial ischemia (CMI), and its allogeneic MSC therapy for HFrEF[68](index=68&type=chunk) - The company submitted two-year data from its CardiAMP HF trial to Japan's PMDA and plans to meet with the FDA to discuss the potential for approval based on existing data[74](index=74&type=chunk)[75](index=75&type=chunk) - The company's cash and cash equivalents of **$980,000** as of June 30, 2025, are not sufficient to fund operations beyond October 2025, raising substantial doubt about its ability to continue as a going concern[111](index=111&type=chunk)[115](index=115&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Collaboration revenue dropped to zero, while research and development expenses increased by approximately **$900,000** to **$2.9 million**, widening the operating loss to **$4.8 million** for the first half of 2025 Comparison of Operations for Six Months Ended June 30 (in thousands) | Item | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration agreement revenue | $0 | $58 | $(58) | | Research and development | $2,898 | $2,041 | $857 | | Selling, general and administrative | $1,879 | $1,941 | $(62) | | **Operating loss** | **$(4,777)** | **$(3,924)** | **$(853)** | [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity is severely constrained with **$980,000** cash and a **$164.9 million** accumulated deficit, as **$3.3 million** was used in operations while **$1.9 million** was raised through financing activities - As of June 30, 2025, the company had cash and cash equivalents of **$980,000** and an accumulated deficit of approximately **$164.9 million**[100](index=100&type=chunk) - Net cash used in operating activities increased to **$3.3 million** in the first six months of 2025, up from **$2.8 million** in the same period of 2024, due to increased trial activities[101](index=101&type=chunk) - Net cash from financing activities was **$1.9 million** in the first six months of 2025, sourced from the sale of common stock and warrants[102](index=102&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company reports no material changes in market risks, with primary exposure limited to short-term cash and cash equivalents, and insignificant foreign currency risk - The company's market risk is limited to its cash and cash equivalents, which have maturities of less than three months[121](index=121&type=chunk) - A hypothetical 100 basis point change in interest rates is expected to have an immaterial impact on financial results[122](index=122&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that as of June 30, 2025, the company's disclosure controls and procedures were effective at a reasonable assurance level[124](index=124&type=chunk) - No changes occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[125](index=125&type=chunk) [Part II. OTHER INFORMATION](index=30&type=section&id=Part%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any pending legal proceedings expected to have a material adverse effect on its business or financial position - Management does not believe the Company is party to any current pending legal proceedings[127](index=127&type=chunk) [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) A significant risk is non-compliance with Nasdaq's **$2.5 million** minimum stockholders' equity requirement, with an extension until September 29, 2025, to regain compliance and avoid delisting - The company is not in compliance with the Nasdaq's minimum stockholders' equity requirement of **$2.5 million** for continued listing[129](index=129&type=chunk) - Nasdaq has granted the company an extension until September 29, 2025, to regain compliance[129](index=129&type=chunk) - Failure to regain compliance will subject the company's common stock to delisting, which could materially affect operations and financial results[129](index=129&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the reporting period - None[130](index=130&type=chunk) [Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate documents, securities agreements, officer certifications, and XBRL data

[Recent Business Highlights](index=1&type=section&id=Recent%20Business%20Highlights) BioCardia reported significant Q2 2025 progress across its therapeutic pipeline, advancing CardiAMP HF, CardiAMP CMI, and CardiALLO programs [CardiAMP Autologous Cell Therapy in Ischemic Heart Failure (BCDA-01)](index=1&type=section&id=CardiAMP%20Autologous%20Cell%20Therapy%20in%20Ischemic%20Heart%20Failure%20%28BCDA-01%29) Two-year Phase 3 CardiAMP HF trial results showed positive trends, leading to regulatory discussions in Japan and the U.S - Two-year Phase 3 CardiAMP HF Trial results indicated a lower incidence of all-cause death and non-fatal MACCE in the treatment group over 24 months (p=0.17)[2](index=2&type=chunk) - The composite endpoint, including quality of life, was **statistically significant (p=0.02)** in the elevated NTproBNP patient subgroup[2](index=2&type=chunk) - Trial data submitted to Japan's PMDA, with Q4 2025 meetings planned for market entry discussions and similar FDA meetings regarding approvability[2](index=2&type=chunk) - The confirmatory CardiAMP HF II Phase 3 trial is actively enrolling U.S. patients, with **$17,500 Medicare reimbursement** per patient offsetting study costs[2](index=2&type=chunk) [CardiAMP Autologous Cell Therapy in Chronic Myocardial Ischemia (BCDA-02)](index=2&type=section&id=CardiAMP%20Autologous%20Cell%20Therapy%20in%20Chronic%20Myocardial%20Ischemia%20%28BCDA-02%29) The BCDA-02 roll-in cohort for chronic myocardial ischemia showed significant improvements in exercise tolerance and angina episodes - Patients in the roll-in cohort showed an average **107-second increase** in exercise tolerance at six months[3](index=3&type=chunk) - Patients experienced an average **82% reduction** in angina episodes compared to baseline[3](index=3&type=chunk) [CardiALLO Allogeneic Cell Therapy in Ischemic Heart Failure (BCDA-03)](index=2&type=section&id=CardiALLO%20Allogeneic%20Cell%20Therapy%20in%20Ischemic%20Heart%20Failure%20%28BCDA-03%29) The CardiALLO (BCDA-03) Phase 1/2 low-dose cohort completed safely, with no adverse events, and the study was recommended to proceed - The low-dose cohort (**20 million cells**) of the Phase 1/2 trial completed with no treatment-emergent adverse events, arrhythmias, rejection, or allergic responses[4](index=4&type=chunk) - The Data Safety Monitoring Board reviewed 30-day safety data and recommended the study proceed as designed in April 2025[4](index=4&type=chunk) [Helix Biotherapeutic Delivery and Intellectual Property](index=2&type=section&id=Helix%20Biotherapeutic%20Delivery%20and%20Intellectual%20Property) BioCardia plans a Q3 2025 DeNovo 510(k) submission for its Helix delivery system and secured a new patent for its catheter technology - The company intends to submit the Helix transendocardial system for DeNovo 510(k) approval in **Q3 2025**[5](index=5&type=chunk) - U.S. Patent No. **12,311,127** was granted, protecting the company's core delivery technology for radial and trans-endocardial catheters[6](index=6&type=chunk) [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) BioCardia reported a net loss of **$2.05 million** in Q2 2025, an increase from **$1.65 million** in Q2 2024, driven by higher R&D expenses Q2 2025 vs Q2 2024 Financial Highlights (in thousands) | Financial Metric | Q2 2025 ($ thousands) | Q2 2024 ($ thousands) | Change ($ thousands) | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $1,400 | $800 | +$600 | CardiAMP HF Trial closeout and CardiAMP HF II enrollment start | | Selling, General & Admin | $700 | $900 | -$200 | Lower professional fees and share-based compensation | | Net Loss | $2,000 | $1,600 | +$400 | Increased R&D expenses | | Net Cash Used in Ops | $1,600 | $1,300 | +$300 | Increased trial activities | - Cash balance was approximately **$980,000** as of June 30, 2025[7](index=7&type=chunk) - Post-quarter end, the company raised **$769,000** in gross proceeds from its ATM program, increasing the cash balance to approximately **$1.1 million**, providing a runway into October 2025[7](index=7&type=chunk) [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a net loss of **$2.05 million** for Q2 2025 and **$4.76 million** for the six months ended June 30, 2025 Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | **Revenue** | $— | $3 | $— | $58 | | **Costs and expenses:** | | | | | | Research and development | 1,368 | 800 | 2,898 | 2,041 | | Selling, general and administrative | 683 | 852 | 1,879 | 1,941 | | **Total costs and expenses** | **2,051** | **1,652** | **4,777** | **3,982** | | **Operating loss** | **(2,051)** | **(1,649)** | **(4,777)** | **(3,924)** | | **Net loss** | **$(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 | 5,059,736 | 1,877,069 | 4,848,922 | 1,776,305 | [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, BioCardia reported total assets of **$2.09 million**, total liabilities of **$3.98 million**, and a stockholders' deficit Condensed Consolidated Balance Sheet Data (in thousands) | | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $980 | $2,371 | | Total assets | $2,089 | $3,724 | | **Liabilities and Stockholders' Equity (Deficit)** | | | | Current liabilities | $3,642 | $2,321 | | Total stockholders' equity (deficit) | $(1,886) | $837 | | Total liabilities and stockholders' equity (deficit) | $2,089 | $3,724 | [Anticipated Upcoming Milestones and Events](index=4&type=section&id=Anticipated%20Upcoming%20Milestones%20and%20Events) BioCardia has outlined key upcoming milestones, including Helix FDA submission, CardiAMP HF regulatory meetings, and CardiALLO funding Upcoming Milestones | Program | Milestone | Anticipated Timing | | :--- | :--- | :--- | | Helix Delivery System | FDA Submission for Approval | Q3 2025 | | BCDA-01 (CardiAMP HF) | Manuscript Publication | Q4 2025 | | BCDA-01 (CardiAMP HF) | Japan PMDA Clinical Review | Q4 2025 | | BCDA-01 (CardiAMP HF) | FDA Meetings on Approvability | Q4 2025 | | BCDA-01 (CardiAMP HF) | CardiAMP HF II Enrollment | Ongoing | | BCDA-02 (CardiAMP CMI) | Top-line Data from Roll-in Cohort | Q4 2025 | | BCDA-03 (CardiALLO HF) | Nondilutive Funding | Q1 2026 |

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 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]