IPO Report: BioCardia (BCDA)

Francis Gaskins |

BioCardia IPO, BioCardia IPO price, BioCardia IPO date, stocks to buy now, small-cap stocks, IPOs this weekBioCardia (BCDA) is a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular diseases with large unmet medical needs. It is based in San Carlos, CA,

Seven other companies are scheduled to IPO for the week of July 13. The full IPO calendar is available at IPO Premium.

SEC Documents

Manager, Joint-managers: Cantor Fitzgerald & Co.

Co-managers: Roth Capital Partners, Maxim Group

End of lockup (180 days): Tuesday, January 12, 2016

End of 25-day quiet period: Monday, August 10, 2015

BCDA scheduled a $50 million IPO with a market capitalization of $146 million at a price range midpoint of $13 for Thursday, July 12, 2015 on Nasdaq.

BioCardia (BCDA) IPO Summary

BCDA is a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular diseases with large unmet medical needs.

If its Phase III pivotal trial is successful, BCDA believes it will be the first company to reach the market with a cell-based therapy to treat heart failure.

BioCardia (BCDA) IPO Valuation

Glossary

Accumulated deficit (mm)

.

.

-$44

     

Per share dilution

.

.

-$8.32

     
             

Valuation Ratios

Mrkt Cap (mm)

Price /Sls

Price /Erngs

Price /BkVlue

Price /TanBV

% offered in IPO

BioCardia (BCDA)

$146

145.6

-20.7

2.8

2.8

34%

             

BioCardia (BCDA) IPO Conclusion

Neutral slightly plus

1st cell-based  therapy to treat heart failure

Ready to start Phase 3 trials, 2nd half of '15

Top line data expected 2nd half of '17

Shareholders may purchase $12.5mm, 25%of IPO

Price-to-book of 2.8

P/E is -21, indicated moderate current cash burn relative to market cap

BioCardia (BCDA) Business

BCDA are a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular diseases with large unmet medical needs.

Lead Product, Phase III Top Line Data Second Half of '17

BCDA’s lead therapeutic candidate is the CardiAMP Cell Therapy System, or CardiAMP. BCDA anticipates enrolling the first patient in its U.S. Food and Drug Administration, or FDA, accepted Phase III pivotal trial for CardiAMP in ischemic systolic heart failure in 2015 and obtaining top-line data in the second half of 2017.

Cell-based Therapy to Treat Heart Failure

If its Phase III pivotal trial is successful, BCDA believes it will be the first company to reach the market with a cell-based therapy to treat heart failure.

BCDA’s second therapeutic candidate is the CardiALLO Cell Therapy System, or CardiALLO.

Ischemic Systolic Heart Failure

BCDA anticipates acceptance of an Investigational New Drug, or IND, application by the FDA in 2016 for a Phase II trial for CardiALLO in ischemic systolic heart failure.

BCDA is committed to applying its expertise in the fields of autologous and allogeneic cell-based therapies to improve the lives of patients with cardiovascular conditions.

Autologous cell therapies use autologous cells, which means the patient’s own cells, while allogeneic cell therapies use allogeneic cells, which means cells from a third party donor.

Companion Diagnostic

CardiAMP is a comprehensive therapeutic treatment that includes a companion diagnostic, and is comprised of (i) a cell potency screening test, (ii) a point of care cell processing platform, and (iii) a biotherapeutic delivery system.

CardiAMP is the first comprehensive therapeutic treatment utilizing a patient’s own cells for the treatment of ischemic systolic heart failure, which is heart failure that develops after a heart attack.

In the screening process with the companion diagnostic, the physician extracts a small sample of the patient’s bone marrow in an outpatient procedure performed under local anesthesia.

The clinic sends the sample to a centralized diagnostic lab, which tests for identified biomarkers from which BCDA generates a potency assay score for the patient.

Biotherapeutic Delivery System

During the treatment, a clinician harvests and then prepares the patient’s own bone marrow mononuclear cells, or autologous cells, using BCDA’s point of care cell processing platform, which a cardiologist then delivers into the heart using its proprietary biotherapeutic delivery system.

BCDA designed the entire procedure to be performed in approximately 60 to 90 minutes, which BCDA believes is substantially faster than alternative cell-based therapies in development.

The patient then leaves the hospital the same or next day.

Phase III End Point

In October 2014, the FDA accepted the design of BCDA’s 250 patient CardiAMP Phase III pivotal trial.

The trial builds on the successful 34 patient Phase II trial and 20 patient Phase I trial utilizing treatment with CardiAMP cells for ischemic systolic heart failure, which is heart failure that follows a heart attack.

The primary endpoint selected for the Phase III pivotal trial is functional capacity as measured by the six minute walk test, an endpoint that has been utilized in the regulatory approval of other therapies, such as Gilead’s Letairis®, Bayer/Actelion’s Adempas® and BioMarin’s Vimizin®.

This endpoint demonstrated statistical significance in the Phase II double-blind placebo-controlled trial for treatment with CardiAMP cells.

Secondary hierarchical endpoints in the Phase III pivotal trial include non-inferiority with respect to survival, non-inferiority with respect to major adverse cardiac events, superiority with respect to quality of life as measured by the Minnesota Living with Heart Failure, or MLHF, Questionnaire, and superiority with respect to survival. Per a planned amendment to the protocol, BCDA expects to commence an interim futility analysis after half of the patients reach the primary endpoint.

BioCardia (BCDA) Intellectual Property

BCDA has a large patent portfolio of issued and pending claims covering methods of use for CardiAMP, CardiALLO, Helix and Morph as well as design and elements of its manufacturing processes.

As of March 2015, BCDA had rights to over 20 patent families that included exclusive rights to 71 U.S. patents with issued or patent pending applications.

In addition to patent and trade secret protection, BCDA expects to receive a 12-year period of regulatory exclusivity from the FDA upon approval of CardiAMP and CardiALLO pursuant to the Biologics Price Competition and Innovation Act.

The exclusivity period, if granted, will run from the time of FDA approval. This exclusivity period, if granted, will supplement the intellectual property protection discussed above, providing an additional barrier to entry for any competitor seeking approval for a bio-similar version of the CardiAMP or CardiALLO cell therapy systems.

BioCardia (BCDA) Competition

BCDA faces potential competition from many different sources, including larger and better-funded companies.

While BCDA believes that CardiAMP’s unique strategy provides it with competitive advantages, particularly given that CardiAMP is designed to be administered in a safe and short procedure, BCDA has identified several companies which are active in the advancement of cell-based and gene-based therapy products in the heart failure arena as of the date of this prospectus.

Not only must BCDA competes with other companies that are focused on cell-based therapy treatments, any products that BCDA may commercialize will have to compete with existing therapies and new therapies that may become available in the future.

Some of the companies developing cell-based and gene-based therapies for cardiac indications include CapriCor, Cardio3 BioSciences, Celladon, CellProthera, Juventas Therapeutics, Mesoblast and Vericel, some of which are in the clinical stages of development with their product candidates.

BioCardia (BCDA) 5% Shareholders Pre-IPO

Entities affiliated with Stertzer Family Trust         18.2%

Sabiah Ltd.       12.8%

Entities affiliated with Modern Version Limited    10.2%

Entities affiliated with Gerald P. Peters   9.2%

Peter Altman, Ph.D.       7.2%

Peter Altman, Ph.D.       7.2%

Simon H. Stertzer, M.D.              18.2%

BioCardia (BCDA) Dividends

No dividends are planned.

BioCardia (BCDA) IPO Use of Proceeds

BCDA expects to receive $44 million from its IPO and use it for the following:

$26 million to fund the FDA accepted Phase III pivotal trial of its CardiAMP Cell Therapy System, its lead therapeutic candidate, including completion and collection of top-line data; and

the remainder for working capital, research and development of additional future products or therapies and general corporate purposes.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer

Companies

Symbol Name Price Change % Volume
BCDA BioCardia Inc 0.33 -0.01 -3.45 223,663

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