BioCardia Q1 2024 Highlights and Financial Results

SUNNYVALE, Calif., May 14, 2024 — BioCardia, Inc. [Nasdaq: BCDA], a company focused on the development of cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, announced its financial results for the first quarter of 2024. Concurrently, it has filed its quarterly report on Form 10-Q for the three months ended March 31, 2024, with the Securities and Exchange Commission. A conference call will be held at 4:30 PM ET today to discuss business highlights, followed by a question-and-answer session.

In the first quarter of 2024, BioCardia reported several clinical advancements across its product pipeline:

1. CardiAMP™ Autologous Cell Therapy for Ischemic Heart Failure:
- An observation of 86% relative risk reduction in mortality for patients with elevated NTproBNP was presented at THT2024.
- A pivotal trial, designed to confirm these findings, has been activated with CMS reimbursement.

2. CardiAMP Autologous Cell Therapy for Refractory Angina:
- Notable improvements in exercise tolerance and reduced chest pain were observed in an open label roll-in cohort.

3. CardiALLO™ Allogeneic Cell Therapy:
- The first results from a low dose cohort for patients with ischemic heart failure were presented at THT2024.

4. StemCardia Partnership:
- A partnership was established for Phase I/II development of biotherapeutic delivery.

5. CellProthera Partnership:
- Phase I/II results of biotherapeutic delivery were accepted for presentation.

6. Operational Cash Burn:
- The operational cash burn for the quarter was reported at $1.5 million.

CEO Peter Altman, Ph.D., emphasized the positive clinical results from the company’s cell therapy product candidates, highlighting significant goals such as submitting CardiAMP autologous cell therapy for approval in Japan and advancing pivotal trials in the United States.

Recent Business Highlights:

1. CardiAMP Heart Failure Trial:
- An ongoing randomized, double-blinded, controlled clinical trial in the U.S. with 125 patients enrolled. Interim results presented at THT2024 showed a 37% relative risk reduction in all-cause heart death equivalents and a 9% relative risk reduction in non-fatal incidents. Subgroup analysis showed significant improvements in patients with elevated NTproBNP.

2. CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial:
- Results from the open label roll-in cohort displayed a 107-second increase in exercise tolerance and an 82% reduction in angina episodes at six months.

3. CardiALLO Allogeneic Cell Therapy for Ischemic HFrEF:
- A 3+3 roll-in dose escalation cohort followed by a 60-patient randomized study. Initial findings showed no adverse treatment reactions.

Biotherapeutic Delivery Partnerships:
- The Helix transendocardial biotherapeutic delivery system is a platform for delivering biologic agents to the heart. BioCardia has entered into partnerships to enhance treatment options for heart disease, offset delivery costs, and share potential revenue.

Morph® Access Innovations:
- The company is on track for FDA submission and approval of the Morph-DNA product family in 2024.

First Quarter 2024 Financial Results:
- Revenues were approximately $55,000, compared to $64,000 in Q1 2023.
- Research and development expenses were $1.2 million, down from $2.4 million in Q1 2023.
- Selling, general, and administrative expenses were $1.1 million, slightly reduced from $1.2 million in Q1 2023.
- The net loss was $2.3 million, a reduction from $3.5 million in Q1 2023.
- Net cash used in operations was $1.5 million, compared to $2.6 million in Q1 2023.

Anticipated Milestones:
1. CardiAMP Cell Therapy for Ischemic Heart Failure:
- Q2: Enrollment in the Heart Failure Trial.
- Q3: Consultation with Japan’s PMDA.
- Q4: Final data and submission to Japan’s PMDA.

2. CardiAMP Cell Therapy for Chronic Myocardial Ischemia:
- Q3: Initiation of the randomized cohort.

3. CardiALLO Allogeneic Cell Therapy:
- Q2: Completion of the low dose cohort.

4. Helix Biotherapeutic Delivery:
- Q2: Third revenue sharing partnership agreement.

5. Morph Access Innovations:
- Q3: FDA approval of the Morph-DNA steerable introducer sheath product family.

BioCardia, based in Sunnyvale, California, is focused on developing therapeutics for cardiovascular and pulmonary diseases. The company’s biotherapeutic platforms include CardiAMP™ and NK1R+ cell therapies. BioCardia also collaborates with other companies to provide delivery systems and development support for heart failure treatments.

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