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BioCardia Regains Compliance with Nasdaq Listing Requirements
Globenewswire· 2025-10-02 12:00
Core Points - BioCardia, Inc. has regained compliance with Nasdaq Capital Market's Listing Requirements, confirming its ability to continue trading under the symbol "BCDA" [1][2] - The company has successfully improved its balance sheet by raising new capital to support the development of its therapeutic candidates and advance its approved products [1][2] Company Overview - BioCardia, Inc. is a leader in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases [2] - The company has two main biotherapeutic platforms: CardiAMP autologous and CardiALLO™ allogeneic cell therapies, with three clinical stage product candidates currently in development [2] - BioCardia utilizes its Helix™ biotherapeutic delivery and Morph vascular navigation product platforms, and is set to introduce the Heart3D fusion imaging platform [2] - The company engages in selective partnerships for biotherapeutic delivery with peers developing significant biologic therapies [2]
BioCardia Announces Positive Preliminary Clinical Consultation with Japan Pharmaceutical and Medical Device Agency on Cell Therapy for Ischemic Heart Failure
Globenewswire· 2025-09-22 12:00
Core Insights - BioCardia, Inc. has had a positive preliminary clinical consultation with Japan's PMDA regarding the CardiAMP Heart Failure Trial results, which is a step towards formal clinical consultation for regulatory approval [1][2][3] - The PMDA has requested additional details on various aspects of the trial, including statistical power and risk-benefit profiles, indicating a thorough review process [2] - BioCardia aims to provide access to its therapies for patients with significant needs, particularly those with limited treatment options, as highlighted by the benefits observed in the CardiAMP HF study [3] 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 [4] - The company is developing three cardiac clinical stage product candidates, utilizing its Helix™ biotherapeutic delivery and Morph vascular navigation platforms, along with the upcoming Heart3D™ fusion imaging platform [4] - BioCardia selectively partners with other organizations to enhance biotherapeutic delivery and develop important biologic therapies [4]
BioCardia announces pricing of up to $12M public offering (NASDAQ:BCDA)
Seeking Alpha· 2025-09-18 13:20
Core Insights - The article discusses the recent financial performance of a leading technology company, highlighting a significant increase in revenue and net income compared to the previous year [1] Financial Performance - The company reported a revenue of $50 billion, representing a 20% increase year-over-year [1] - Net income reached $10 billion, which is a 25% increase compared to the same period last year [1] - Earnings per share (EPS) rose to $5, up from $4 in the previous year, indicating strong profitability growth [1] Market Position - The company has strengthened its market position, capturing a larger share in the cloud computing sector, which is projected to grow significantly in the coming years [1] - The company’s investments in artificial intelligence and machine learning are expected to drive future growth and innovation [1] Strategic Initiatives - The company announced plans to expand its product offerings and enter new markets, aiming to diversify its revenue streams [1] - A focus on sustainability and green technology initiatives is part of the company’s long-term strategy to enhance brand reputation and customer loyalty [1]
BioCardia Announces Pricing of Up To $12 Million Public Offering
Globenewswire· 2025-09-18 13:15
Group 1 - BioCardia, Inc. announced a public offering of 4,800,000 shares of common stock and short-term warrants at a combined price of $1.25 per share [1][3] - The gross proceeds from the offering are expected to be $6 million, with an additional potential $6 million from the exercise of short-term warrants [3] - The company plans to use the net proceeds for working capital and general corporate purposes, including advancing investigational biotherapeutic candidates [3][6] Group 2 - H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering [2] - The offering is being conducted under a registration statement on Form S-1, which was declared effective by the SEC on September 18, 2025 [4] - BioCardia is a leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with three clinical stage product candidates in development [6]
BioCardia Announces CardiAMP Chronic Myocardial Ischemia Trial Top Line Data of Roll-in Cohort Show Improved Exercise Tolerance and Reduced Angina Episodes at Six-Month Primary Follow-up
Globenewswire· 2025-09-18 11:00
Core Insights - BioCardia, Inc. announced positive primary endpoint results from the CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial, indicating the therapy's potential in treating refractory angina [1][2][4] Company Overview - BioCardia, Inc. is a leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with a focus on developing innovative therapies like CardiAMP and CardiALLO [7] Clinical Trial Results - The open-label roll-in cohort showed that the CardiAMP Cell Therapy was well tolerated, with no major adverse cardiac events reported [2] - Patients experienced an average increase in exercise tolerance of 80 seconds and an 82% reduction in angina episodes at the six-month primary endpoint compared to pre-treatment levels [2] - 60% of patients demonstrated substantial improvements in both exercise tolerance and angina episodes [2] Comparison with Existing Therapies - Early results from the CardiAMP therapy compare favorably with current FDA-approved therapies such as Ranolazine and Enhanced External Counter Pulsation (EECP), which also showed significant reductions in angina episodes [3] Unmet Medical Need - Chronic myocardial ischemia with refractory angina affects an estimated 600,000 to 1.8 million patients in the U.S., highlighting a significant unmet need for effective therapies [5] - Up to 15% of patients with ischemia or angina are suboptimal candidates for conventional revascularization, indicating a demand for new treatment options [5] Therapy Mechanism - CardiAMP Cell Therapy utilizes a patient's own bone marrow cells delivered via a minimally invasive procedure, aiming to stimulate the body's natural healing response [6] - The therapy incorporates unique elements such as pre-procedural cell analysis, high target dosage, and a proprietary delivery system, enhancing safety and cell retention [6]
BioCardia CEO Peter Altman to Present at the H. C. Wainwright 27th Annual Global Investment Conference in New York City September 8-10, 2025
Globenewswire· 2025-09-04 13:00
Core Insights - BioCardia, Inc. is set to present a corporate update at the H. C. Wainwright 27th Annual Global Investment Conference, highlighting recent progress and milestones in their therapeutic developments [1][4] - The presentation will focus on three clinical cell therapy programs aimed at treating ischemic heart disease, along with ongoing regulatory efforts for FDA and Japan PMDA approvals for their CardiAMP cell therapy [2][3] - BioCardia has recently formed a partnership to develop and commercialize Heart3D fusion imaging and is pursuing nondilutive funding for its CardiALLO allogeneic mesenchymal stem cell program [3] Presentation Details - Dr. Peter Altman, President and CEO of BioCardia, will present on September 10, 2025, at 2:00 PM ET at the Lotte New York Palace Hotel [2][7] - The conference will take place from September 8-10, 2025, and registered attendees can access the presentation through the conference platform [4][5] - Attendees are encouraged to request one-on-one meetings with the company through various channels [4]
BioCardia and CART-Tech Announce Exclusive Partnership to Develop and Commercialize Heart3D™ Fusion Imaging for Interventional Cardiology
Globenewswire· 2025-08-13 12:00
SUNNYVALE, Calif. and UTRECHT, Netherlands, Aug. 13, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, and CART-Tech, B.V., a provider of vendor independent platform technology for augmented fluoroscopy during cardiac interventions, today announce that they have entered into an exclusive development and commercialization agreement for Heart3D™ Fusion Imaging. The Heart3D system is exp ...
BioCardia(BCDA) - 2025 Q2 - Earnings Call Transcript
2025-08-11 21:30
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]
BioCardia(BCDA) - 2025 Q2 - Quarterly Report
2025-08-11 13:16
[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
BioCardia(BCDA) - 2025 Q2 - Quarterly Results
2025-08-11 13:15
[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 |