BioCardia Reports Second Quarter 2024 Business Highlights and Financial Results

Rhea-AI Summary

BioCardia (NASDAQ: BCDA) reported Q2 2024 financial results and business highlights. Key points include:

1. Final patient follow-up data for CardiAMP Heart Failure I trial expected in late Q3 2024.
2. Enrollment commenced in confirmatory pivotal CardiAMP Heart Failure II trial.
3. Promising early results from CardiAMP therapy for refractory angina.
4. Operational cash burn reduced to $1.3M for the quarter.
5. Revenues were $3,000 in Q2 2024, down from $43,000 in Q2 2023.
6. Net loss decreased to $1.6M in Q2 2024 from $3.4M in Q2 2023.
7. R&D expenses decreased to $800,000 from $2.3M year-over-year.
8. SG&A expenses reduced to $852,000 from $1.2M year-over-year.

BioCardia aims to regain NASDAQ compliance and deliver final data for CardiAMP Heart Failure I trial in Q4 2024.

Positive

• Reduced operational cash burn to $1.3M for the quarter
• Net loss decreased to $1.6M in Q2 2024 from $3.4M in Q2 2023
• R&D expenses decreased to $800,000 from $2.3M year-over-year
• SG&A expenses reduced to $852,000 from $1.2M year-over-year
• Promising early results from CardiAMP therapy for refractory angina
• Enrollment commenced in confirmatory pivotal CardiAMP Heart Failure II trial

Negative

• Revenues decreased to $3,000 in Q2 2024 from $43,000 in Q2 2023
• Completed reverse stock split to regain compliance with NASDAQ listing requirements

Insights

Financial Analyst

BioCardia's Q2 2024 results show a significant reduction in operational costs, with net cash burn decreasing to $1.3 million from $3.2 million in Q2 2023. This 59% reduction in cash burn is impressive, potentially extending the company's runway. However, revenues dropped sharply to just $3,000 from $43,000 year-over-year, which is concerning.

The company's R&D expenses decreased by 65% to $800,000, mainly due to the completion of enrollment in the CardiAMP Cell Therapy Heart Failure Trial. While this cut costs, it's important to monitor if it impacts future product development. The net loss improved to $1.6 million from $3.4 million, a positive trend if sustained.

BioCardia's focus on late-stage clinical trials and potential FDA approvals could be pivotal for future revenue growth. The upcoming milestones, particularly the final data from CardiAMP Heart Failure I Trial and potential FDA approval for Morph DNA, could be significant catalysts for the stock.

Medical Research Analyst

BioCardia's pipeline shows promise, particularly with the CardiAMP cell therapy programs. The CardiAMP Heart Failure II trial's enrollment progress and the promising early results from the refractory angina study are positive indicators. The company's unique position in cardiac cell therapy, with FDA breakthrough designation and Medicare reimbursements for two indications, sets it apart in the competitive landscape.

The upcoming final data from the CardiAMP Heart Failure I Trial in Q4 2024 is a critical milestone. Previous trends showing reduced mortality and major adverse cardiac events could significantly impact the company's future if confirmed in the final data. The diversification into biotherapeutic delivery partnerships and Morph Access Innovations also provides multiple avenues for growth.

However, the slow pace of clinical trials and the inherent risks in cell therapy development remain concerns. The success of BioCardia heavily depends on these late-stage clinical outcomes, making the upcoming results important for the company's future.

Legal Expert

BioCardia's intellectual property portfolio, with over 60 patents and applications worldwide, provides a strong foundation for protecting its innovations. The recent granting of two U.S. patents (No: 11,986,611 and 12,036,371) strengthens the company's position in cardiac delivery systems, potentially creating barriers to entry for competitors until 2035-2036.

The company's compliance efforts, including the reverse stock split to meet NASDAQ listing requirements, demonstrate proactive management of regulatory risks. However, investors should note that maintaining compliance is an ongoing process that requires vigilance.

BioCardia's multiple partnerships and collaborations, such as with CellProthera, could expose the company to potential contractual risks. As the company progresses towards commercialization, it will face increased regulatory scrutiny, particularly from the FDA. The upcoming submission of clinical data to FDA and Japan's PMDA in Q4 will be a critical juncture for assessing regulatory risks and potential pathways to market.

SUNNYVALE, Calif., Aug. 13, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the second quarter of 2024 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2024 with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights. Following management’s formal remarks, there will be a question-and-answer session.

Recent Business Highlights

BCDA-01: CardiAMP® autologous cell therapy in ischemic heart failure of reduced ejection fraction

• Active monitoring of source data in our CardiAMP Heart Failure I trial of our lead autologous cell therapy continues, and we expect final patient follow-up data in late Q3 2024.
• Patient enrollment commenced in the confirmatory pivotal CardiAMP Heart Failure II trial. Five patients have been consented to date.

BCDA-02: CardiAMP autologous cell therapy in chronic myocardial ischemic with refractory angina

• Early results from the open label roll-in cohort of the CardiAMP autologous cell therapy for patients with refractory angina are promising, with treated patients showing improved exercise tolerance and greatly reduced episodes of angina (chest pain).
  

BCDA-03: CardiALLO Cell Therapy in Ischemic Heart Failure

• Second patient in low dose cohort passed the safety readout with no adverse events.
  

Helix Biotherapeutic Delivery

• CellProthera and BioCardia announced success from a collaborative Phase II trial of ProtheraCytes for the treatment of acute myocardial infarction led by CellProthera, and announced plans to continue the relationship into Phase III.
  

Morph Access Innovations

• Submission of 510(k) for approval of our patented Morph® DNA™ Steerable Introducer Sheath product family for cardiac, aorto-ostial, and peripheral clinical indications.
  

Business

• Operational cash burn of $1.3M for the quarter.
• Completed reverse stock split to regain compliance with NASDAQ listing requirements.

“Since the end of the first quarter, we have accomplished a great deal on a significantly reduced operational cash burn,” said BioCardia CEO Peter Altman, Ph.D. “We intend to regain compliance with NASDAQ and soon deliver final data in CardiAMP Heart Failure I randomized placebo-controlled trial.”

Altman continues, “BioCardia is well poised to deliver significant shareholder returns based on our late stage clinical development efforts, biotherapeutic delivery partnering, and approved products. There are many working on cell and gene therapy to the heart which are pursuing important efforts. However, to our knowledge, in this biointerventional cardiology space, only BioCardia has secured a breakthrough designation from FDA, received Medicare reimbursements for not just one, but two clinical indications. BioCardia is one of two companies that has successfully treated hundreds of patients with its lead cardiac cell therapy for heart failure and enrolled a Phase III clinical trial. To our knowledge, only BioCardia has shown trends towards both reduced mortality and reduced major adverse cardiac events in its primary endpoint across all patients in a randomized double blinded clinical trial. Only BioCardia is today enrolling in a confirmatory pivotal trial for approval of a heart failure cell therapy, using what I believe is the only clinical use transendocardial delivery system in the world. This delivery system, developed and manufactured by the Company, enables our efforts and those of biointerventional therapeutic partners in three unique cardiac indications today. We remain optimistic and see many pathways towards building great shareholder value in the near future and helping millions of patients.”

Intellectual Property

The Company’s intellectual property portfolio is robust, with more than 60 patents and patent applications worldwide.

In June, the Company announced that the Unites States Patent Office granted Patent No: 11,986,611 titled “Radial and Transendocardial Delivery Catheter,” with a patent term that will expire in 2036. This invention relates to medical methods and systems suitable for substance delivery to the heart via a radial artery and for the intracardiac delivery of cellular aggregates and other agglomerated materials.

In July, the Company announced that the Unites States Patent Office granted Patent No: 12,036,371 titled “Method of Accessing the Left Atrium with a Multi-Directional Steerable Catheter,” with a patent term that will expire in 2035. This invention relates to medical methods for transseptal access to the heart using steerable introducers based on the Company’s Morph DNA technology.

Second Quarter 2024 Financial Results:

• Revenues were approximately $3,000 for the three months ended June 2024, compared to approximately $43,000 for the three months ended June 2023.
• Research and development expenses were approximately $800,000 for the three months ended June 2024 compared to approximately $2.3 million for the three months ended June 2023 following the completion of enrollment in the CardiAMP Cell Therapy Heart Failure Trial in the second half of 2023.
• Selling, general and administrative expenses were approximately $852,000 for the three months ended June 2024 compared to approximately $1.2 million for the three months ended June 2023.
• Our net loss was approximately $1.6 million for the three months ended June 2024, compared to approximately $3.4 million for the three months ended June 2023.
• Net cash used in operations for the three months ended June 2024 was approximately $1.3 million, as compared to approximately $3.2 million for the three months ended June 2023.
  

ANTICIPATED UPCOMING MILESTONES AND EVENTS:

• BCDA-01: CardiAMP Cell Therapy for Ischemic Heart Failure of Reduced Ejection Fraction
  • Q3: Final patient follow-up visit in CardiAMP Heart Failure I Trial
  • Q3: Enrollment in the CardiAMP Heart Failure II Trial
  • Q4: Final data from the CardiAMP Heart Failure I Trial
  • Q4: - Submission of clinical data to FDA and Japan’s PMDA
    
    
• BCDA-02: CardiAMP autologous cell therapy in chronic myocardial ischemic with refractory angina
  
  • Q3: Final patient treatment in roll in cohort

• Helix Biotherapeutic Delivery Business
  • Q3/4: Biotherapeutic delivery partnership revenues and new partner
• Morph Access Innovations Business
  • Q3: FDA approval of Morph DNA steerable introducer sheath product family

About BioCardia®

BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP™ autologous and NK1R+ allogeneic cell therapies are the Company’s biotherapeutic platforms that enable four product candidates in development. BioCardia also partners with other biotherapeutic companies to provide its delivery systems and development support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction. The CardiAMP Cell Therapy Trial for Heart Failure has been supported financially by the Maryland Stem Cell Research Fund and the Center for Medicare and Medicaid Services. For more information visit: www.BioCardia.com.

Conference call access:

Participants can register for the conference by navigating to https://dpregister.com/sreg/10191562/fd3d36338a. Please note that registered participants will receive their dial-in number upon registration. For those who have not registered, to listen to the call by phone, interested parties within the U.S. should call 1-833-316-0559 and international callers should call 1-412-317-5730 and ask to be connected to the BioCardia call. All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the BioCardia call. The conference call will also be available through a live webcast, which can be accessed through the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=BLDb4kwc.

A webcast replay of the call will be available approximately one hour after the end of the call at the above links. To access the replay internationally, please use the link https://services.choruscall.com/ccforms/replay.html. A telephonic replay of the call will be available and may be accessed by calling 1-877-344-7529 (domestic), 1-412-317-0088 (international) or 855-669-9658 (Canada) by using access code 5376275.

Forward Looking Statements

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the enrollment in our clinical trials, the availability of data from our clinical trials, filings and communications with the FDA and Japan’s Pharmaceutical and Medical Device Agency, FDA and Japanese product clearances, the efficacy and safety of our products and therapies, preliminary conclusions about new data, the achievement of any of the anticipated upcoming milestones, our positioning for growth or the market for our products and therapies, the expected benefits of our intellectual property, future prospects, regulatory timelines, and other statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, the ability to enter into licensing and partnering arrangements and overall market conditions. We may find it difficult to enroll patients in our clinical trials due to many factors, some of which are outside of our control. Slower than targeted enrollment could delay completion of our clinical trials and delay or prevent the development of our therapeutic candidates. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.

We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 27, 2024, under the caption titled “Risk Factors,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

BioCardia, Inc.
Condensed Consolidated Statements of Operations
(Unaudited in thousands, except share and per share amounts)
		Three Months ended June 30,								Six Months ended June 30,
		2024				2023				2024				2023
Revenue:
Collaboration agreement revenue	$	3			$	43			$	58			$	107
Costs and expenses:
Research and development		800				2,314				2,041				4,698
Selling, general and administrative		852				1,181				1,941				2,371
Total costs and expenses		1,652				3,495				3,982				7,069
Operating loss		(1,649	)			(3,452	)			(3,924	)			(6,962	)
Other income (expense):
Total other income, net		3				28				11				37
Net loss	$	(1,646	)		$	(3,424	)		$	(3,913	)		$	(6,925	)
Net loss per share, basic and diluted	$	(0.88	)		$	(2.52	)		$	(2.20	)		$	(5.12	)
Weighted-average shares used in computing net loss per share, basic and diluted		1,877,069				1,358,968				1,776,305				1,352,094

BioCardia, Inc.
Selected Balance Sheet Data
(amounts in thousands)
		June 30,				December 31,
		2024(1)				2023(1)
Assets:
Cash and cash equivalents	$	1,421			$	1,103
Other current assets		152				358
Property, plant and equipment and other noncurrent assets		1,317				1,526
Total assets	$	2,890			$	2,987
Liabilities and Stockholders' Deficit
Current liabilities	$	4,071			$	3,608
Operating lease liability - noncurrent		780				982
Total stockholders' deficit		(1,961	)			(1,603	)
Total liabilities and stockholders' deficit	$	2,890			$	2,987

(1) June 30, 2024 amounts are unaudited. December 31, 2023 amounts were derived from the audited Consolidated Financial Statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission on March 27, 2024.

FAQ

What were BioCardia's (BCDA) Q2 2024 financial results?

BioCardia reported revenues of $3,000, a net loss of $1.6M, R&D expenses of $800,000, and SG&A expenses of $852,000 for Q2 2024. The operational cash burn was $1.3M for the quarter.

When is the final data from the CardiAMP Heart Failure I Trial expected for BCDA?

BioCardia expects to deliver final data from the CardiAMP Heart Failure I Trial in Q4 2024.

What is the status of BioCardia's (BCDA) CardiAMP Heart Failure II trial?

Patient enrollment has commenced in the confirmatory pivotal CardiAMP Heart Failure II trial, with five patients consented to date.

How has BioCardia (BCDA) addressed its NASDAQ listing compliance?

BioCardia completed a reverse stock split to regain compliance with NASDAQ listing requirements.

What are the upcoming milestones for BioCardia (BCDA) in Q3 2024?

In Q3 2024, BioCardia anticipates the final patient follow-up visit in CardiAMP Heart Failure I Trial, continued enrollment in CardiAMP Heart Failure II Trial, and FDA approval of Morph DNA steerable introducer sheath product family.