SUNRISE, Fla., May 15 /PRNewswire-FirstCall/ -- Bioheart, Inc. a biotechnology company that is focused on the development of autologous (patient-derived) cell therapies and devices for the treatment of chronic and acute heart damage, today announced financial results for the quarter ended March 31, 2008.
Revenues for the quarter ended March 31, 2008 increased to $25,995 compared to $13,805 in first quarter of 2007. During the quarter, we also recognized $61,500 of development revenue for services performed under a clinical registry agreement. The Company reported a net loss for the first quarter of 2008 of $3.3 million, or $(0.24) per share, compared to a net loss of $2.3 million, or $(0.18) per share, for the same quarter last year. The increase in the Company’s net loss in the first quarter of 2008 as compared to the first quarter of 2007 is primarily attributable to increased interest expense related to $10 million of debt incurred by the Company in June 2007. Amortization of the value of warrants issued in connection with the Company’s $5 million loan from Bank of America comprised a substantial portion of this interest expense. The value of these warrants was fully amortized during the quarter and, accordingly, the Company expects its interest expense to decrease in the second quarter of 2008.
Research and development expenses for the first quarter of 2008 were $1.4 million, comparable to $1.4 million in the first quarter last year. The primary focus of the Company’s research and development activities during the quarter related to the MARVEL and SEISMIC Trials. The Company ended the quarter with cash and cash equivalents totaling $4.8 million.
“This past quarter was significant for Bioheart as we made a lot of progress in a short period of time, both in our business, with the completion of the IPO, and clinically, with the presentation of final results from our MYOHEART and SEISMIC Trials,” said William M. Pinon, president and chief executive officer of Bioheart. “We are planning to build on that momentum as we focus on MARVEL Trial site activation and patient enrollment, in order to expand our clinical body of evidence in treating congestive heart failure patients. This Phase II/III, 330-patient, double-blind, randomized, placebo-controlled trial is designed to study the safety and efficacy of our MyoCell therapy on myocardial function in congestive heart failure patients who have had prior heart attacks.”
The MARVEL Trial is the largest clinical trial of its kind to date, investigating the use of autologous myoblasts to treat patients suffering from congestive heart failure. These myoblasts, adult stem cells that are precursors to muscle, are derived from the patient’s own body. When injected into scar tissue within the heart wall, myoblasts have shown they are capable of engrafting in the damaged tissue and differentiating into mature muscle cells capable of augmenting cardiac function.
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 muscle stem cell therapy designed to populate regions of scar tissue within a patient’s heart with new living cells 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-tissue derived stem cell treatment for acute heart damage, and MyoCell(R) SDF-1, a therapy utilizing autologous cells that are genetically modified to express additional potentially therapeutic proteins.
MyoCell, MyoCell SDF-1 and MyoCath 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 (ix) intense competition. The Company is also subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2007, as amended by Amendment No. 1 on Form 10-K/A.
CONTACT: William Kline, Chief Financial Officer, or Nicholas Burke, VP -
Financial Operations, both of Bioheart, Inc., +1-954-835-1500; or Joe Diaz,
Joe Dorame, or Robert Blum, all of Lytham Partners, LLC, +1-602-889-9700,
for Bioheart, Inc.
