BioCardia Inc (BCDA) Reports Q3 2023 Financial Results and Business Updates

In this article:
  • BioCardia Inc (NASDAQ:BCDA) announced Q3 2023 financial results and business highlights, including updates on clinical trials and strategic focuses.

  • Interim data from the CardiAMP Cell Therapy trial showed promising results, with significant risk reductions in cardiac events.

  • Financial results revealed a net loss decrease compared to the same period last year, with a focus on advancing clinical programs in a cash-neutral manner.

  • Upcoming milestones include continued clinical developments and potential licensing and development partnerships.

On November 8, 2023, BioCardia Inc (NASDAQ:BCDA), a leader in the development of cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, released its third-quarter financial results for the year. The company also filed its quarterly report on Form 10-Q for the three and nine months ended June 30, 2023, with the Securities and Exchange Commission. A conference call was held to discuss these updates, where management provided insights into the company's strategic direction and clinical progress.

Business Highlights and Clinical Developments

BioCardia's CEO, Peter Altman, expressed increased confidence in the company's autologous CardiAMP Cell Therapy program, citing recent interim data from 136 procedures. The company is strategically advancing its clinical programs, aiming for cash-neutral operations, leveraging Medicare reimbursement, and seeking grants and partnerships. Altman noted, "The success of these efforts will be evidenced by reductions to our net loss, with increases in partnering and grant revenues, while delivering significant clinical data on our therapeutic candidates."

The CardiAMP Cell Therapy Trial for Heart Failure, although paused based on a DSMB recommendation, showed a 37% relative risk reduction of cardiac death equivalents and an 18% relative risk reduction in MACCE for patients followed up to 24 months. Notably, patients with higher NT-proBNP levels experienced even greater benefits, including a 59% relative risk reduction in mortality and a 54% relative risk reduction of MACCE. These findings have led to the submission of a proposed second pivotal study protocol to the FDA, targeting a specific patient subset.

Additionally, BioCardia is making strides in its CardiAMP Cell Therapy Trial for Chronic Myocardial Ischemia and the CardiALLO Allogeneic Cell Therapy for Ischemic HFrEF. The company's Helix Biotherapeutic Delivery System continues to be a focal point for potential licensing and development partnerships.

Third Quarter 2023 Financial Results

The financial results for the third quarter of 2023 reflected a net loss of $2.574 million, or $0.12 per share, a decrease from the net loss of $3.057 million, or $0.17 per share, in the same period last year. Total revenue for the quarter was $357 thousand, primarily from collaboration agreement revenue, compared to $212 thousand in the third quarter of 2022. Research and development expenses decreased to $1.872 million from $2.144 million, and selling, general, and administrative expenses also saw a slight decrease. The company ended the quarter with $1.835 million in cash and cash equivalents.

BioCardia's balance sheet data showed total assets of $3.747 million as of September 30, 2023, with current liabilities of $3.330 million and a stockholders' equity deficit of $660 thousand.

Looking Ahead

Looking forward, BioCardia anticipates several milestones, including the completion of the roll-in cohort for the Chronic Myocardial Ischemia trial and the treatment of the first patient in the CardiALLO Allogeneic Cell Therapy trial. The company also expects to finalize up to two licensing and development relationships in the fourth quarter.

BioCardia remains committed to advancing its therapeutic candidates and delivering value to its stakeholders through strategic partnerships and clinical progress. The company's focus on developing innovative treatments for cardiovascular and pulmonary diseases positions it as a potential leader in the biotherapeutic industry.

For more detailed information on BioCardia's financials and business updates, investors and interested parties can access the conference call and webcast replay through the links provided in the earnings release.

For further information and updates on BioCardia Inc (NASDAQ:BCDA), please visit www.BioCardia.com.

Explore the complete 8-K earnings release (here) from BioCardia Inc for further details.

This article first appeared on GuruFocus.

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