Stem cell biotech BioCardia drops $50M IPO

Stem cells

A new week, another ditched IPO as BioCardia fails to find enough interest in its regenerative heart failure candidate in a tough financial market.

The San Carlos, CA-based BioCardia had last summer filed a public offering designed to raise around $50 million ($12 to $14 for 3.85 million shares)--but a month later announced it was to delay its IPO due to a lack of buyers in the company.

The biotech has now said it will drop its plans to float completely, hitting a double whammy of a lack of interest and a weak IPO market, with BioCardia blaming “unfavorable market conditions” in its SEC filing.

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The regenerative medicine specialist had planned to use the funds to push on with its pivotal Phase III study for a new cell therapy for ischemic systemic heart failure, with data originally due out next year.  

The FDA cleared the company for late-stage trials in late 2014, but its CEO Peter Altman said at the time it didn’t have enough funds to complete a 250-patient Phase III study, hence the need for an IPO--and why its dropping of an offering will likely hit the company’s future plans hard.

In a previous Phase II study with 30 patients, CardiAMP, which is a bone marrow-derived therapy, “supported efficacy relative to patient quality of life and functional capacity, which was shown to be both statistically and clinically significant,” according to the company.

As the treatment uses a heart failure patient’s own bone marrow cells (collected from their hip bone), BioCardia believes this removes much of the cost of development, and could “enable [CardiAMP] to be extremely cost-effective in comparison to other biotherapeutics in development.”

The biotech is looking to offer a package treatment as its approach also incorporates a biomarker that checks if a patient’s own bone marrow cells are a good candidate for treatment.  

The cells can then be prepared at a patient’s bedside and delivered into a patient’s vasculature at a specific dosage of cells during a cardiac catheterization procedure.

The biotech is also working on trials for a related treatment known as CardiALLO. Where the CardiAMP system uses a patient’s own cells, its CardiALLO system uses culture-expanded, bone marrow-derived mesenchymal stem cells from a universal donor. This allows the cells to be obtained “off the shelf” from a pharmacy, removing the need for a bone marrow aspirate for the patient and providing an option for patients who can’t use its CardiAMP treatment.

This follows a tough week for the biotech IPO market, as Denmark’s Bavarian Nordic and the Paris-based biotech GenSight have also dropped their IPOs in the last week due to the ongoing headwinds in the IPO market.

There was small bright spot in the darkness, however, with Servier-backed GeNeuro getting off its IPO last week for $37.2 million on the Euronext exchange. The Swiss biotech is looking to develop a new therapy in the MS space.

BioCardia was founded in 2002 and booked $1 million in sales for the 12 months ended March 31, 2015. It had planned to list on the Nasdaq under the symbol "BCDA," according to Renaissance Capital.

- check out BioCardia’s IPO SEC filing

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