SUNRISE, Fla., March 27 /PRNewswire-FirstCall/ -- Bioheart, Inc. today announced financial results for the year ended December 31, 2007.
Revenues for the year were $313,000 compared to $106,000 in 2006. Research and development expenses for 2007 were $11.3 million compared to $6.9 million in 2006; an increase of 64%. The increase in R&D expenses was primarily due to the accrual of $3.0 million in license fees for the primary patent protecting the Company’s flagship development candidate, MyoCell(R) Clinical Cell Therapy.
In addition to the MyoCell patent licensing fee, the Company incurred R&D expenses of approximately $3.0 million related to the MYOHEART and SEISMIC Clinical Trials; approximately $3.0 million in costs related to commencement of the MARVEL Clinical Trial and approximately $800,000 related to advanced research.
The Company reported a net loss for the year of $18.1 million, or $(1.37) per share, compared to $13.2 million, or $(1.10) per share, in the previous year.
“As a new public company, we are pleased to make this initial financial report to our shareholders,” said William M. Pinon, president and chief executive officer of Bioheart. “We are greatly encouraged by the progress being made in developing our technologies and in establishing Bioheart as a public company for the benefit of our shareholders. We believe we have significant potential to develop cardiac care treatments and protocols that will benefit patients worldwide.”
The Company’s financial statements for the fiscal year ended December 31, 2007, included in its Annual Report on Form 10-K, which will be filed with the Securities and Exchange Commission on March 28, 2008, contain a going concern uncertainty from the Company’s independent registered public accounting firm, Grant Thornton LLP. The Company anticipates that it will need to secure additional capital within the next five months to finance its operations as currently planned. This announcement is being made in compliance with Nasdaq Marketplace Rule 4350(b)(1)(B), which requires public disclosure of receipt of an audit opinion that contains a going concern qualification.
Bioheart is currently enrolling patients in the MARVEL Phase II/III clinical trial of MyoCell. The MARVEL Trial is being conducted in North America and Europe. The 330-patient trial is designed to assess the safety and efficacy of MyoCell therapy on myocardial function in congestive heart failure patients who have had prior heart attacks. It is the largest clinical trial to date investigating the use of autologous myoblasts to treat patients suffering from congestive heart failure. MyoCell is an innovative clinical cell therapy designed to populate regions of the scar tissue within a patient’s heart with living muscle tissue for the purpose of improving cardiac function in chronic heart failure patients. MyoCell uses myoblasts, adult stem cells that are precursors to muscle, which are derived from the patient’s own body. When injected into scar tissue within the heart wall, myoblasts have shown to be capable of engrafting in the damaged tissue and differentiating into mature muscle cells. The proceeds from the initial public offering completed in February 2008 are being used to finance the commencement of the full-scale enrollment of this important study.
In January 2008, Warren Sherman, MD, Director, Cardiac Cell-based Endovascular Therapies, Columbia University Medical Center, presented final 12-month results of the MYOHEART Trial at the Fourth Annual International Conference on Cell Therapy for Cardiovascular Diseases in New York. Results of this Phase I dose-escalating study suggested trends in improved Quality of Life measurements sustained out to 12 months, with no unexpected serious adverse events related to the therapy, given this patient population.
Final six-month results of the SEISMIC Trial will be presented on April 1 at the American College of Cardiology Scientific Sessions in Chicago by Patrick Serruys, MD, PhD. Chief, Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center -- Rotterdam, the Netherlands. The 40-patient Phase II SEISMIC trial, conducted in Europe, is designed to look at the safety of MyoCell therapy.
“As our clinical studies continue to produce data that we believe will confirm the viability of our treatment protocols, we believe Bioheart is better positioned than at any time in its history for future growth,” commented Pinon. “We are dedicated to the execution of our strategic business plan and to enhance the value of our shareholders investments.”
Conference Call:
The Company will hold a conference call and webcast to discuss the financial results of the just concluded fourth quarter and year on Thursday, March 27, 2008 at 4:30 pm EASTERN. Interested parties can access the call by dialing (877) 858-9308 or (706) 643-0580, or can listen via a live Internet web cast, which can be found at http://www.bioheartinc.com. A replay of the call is available via webcast at http://www.bioheartinc.com for 30 days or by playback at (800) 642-1687 or (706) 645-9291 through March 29, 2008. Please use conference id #: 39978839 for the replay.
About Bioheart, Inc.:
Bioheart, Inc. is a biotechnology company focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage. Its lead product candidate, MyoCell, is an innovative clinical cell therapy designed to populate regions of scar tissue within a patient’s heart with autologous muscle cells, or cells from the patient’s body, for the purpose of improving cardiac function in chronic heart failure patients. The Company’s pipeline includes multiple product candidates for the treatment of heart damage, including Bioheart Acute Cell Therapy, an autologous, adipose cell treatment for acute heart damage, and MyoCell SDF-1(TM), a therapy utilizing autologous cells genetically modified to express additional growth factors.
MyoCell and MyoCell SDF-1 are trademarks of Bioheart, Inc.
Forward-Looking Statements:
Except for historical matters contained herein, statements made in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Without limiting the generality of the foregoing, words such as “may,” “will,” “to,” “plan,” “expect,” “believe,” “anticipate,” “intend,” “could,” “would,” “estimate,” or “continue” or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.
Investors and others are cautioned that a variety of factors, including certain risks, may affect our business and cause actual results to differ materially from those set forth in the forward-looking statements. These risk factors include, without limitation, (i) our ability to secure additional financing; (ii) the timely success and completion of our clinical trials; (iii) the occurrence of any unacceptable side effects during or after preclinical and clinical testing of our product candidates; (iv) regulatory approval of our product candidates; (v) our dependence on the success of our lead product candidate; (vi) our inability to predict the extent of our future losses or if or when we will become profitable; (vii) our ability to protect our intellectual property rights; (viii) our inability to predict the extent of our future losses or if or when we will become profitable; and (viii) intense competition. The Company is also subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including Post-Effective Amendment No. 5 to its Registration Statement on Form S-1 (Registration No. 333-140672) filed on February 13, 2008.
CONTACT: William Kline, Chief Financial Officer, or Nicholas Burke, VP -
Financial Operations, +1-954-835-1500; or Joe Diaz, or Joe Dorame, or
Robert Blum, +1-602-889-9700, all of Lytham Partners, LLC, for Bioheart,
Inc.
Web site: http://www.bioheartinc.com/
