SUNRISE, Fla., May 15 /PRNewswire-FirstCall/ -- Bioheart, Inc. (Nasdaq:
BHRT) 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.
-- On February 19, 2008, the Company completed its initial public offering
(IPO) of common stock for gross proceeds of approximately $5.8 million.
The net cash proceeds from the IPO are expected to be utilized to
commence full-scale enrollment in a Phase II/III MARVEL Clinical Trial
of MyoCell(R) in the U.S. and Europe.
-- On January 18, 2008, the final 12-month results of the MYOHEART Trial,
a Phase I dose-escalation study of MyoCell in the United States, the
Company's lead product candidate, were presented at the Fourth Annual
International Conference on Cell Therapy for Cardiovascular Diseases
(NY). The results, presented by Warren Sherman, MD, Principal
Investigator and Director, Cell-based Endovascular Therapies, Columbia
University Medical Center, NY, suggested trends in improved quality of
life measurements sustained out to 12 months following treatment,
without unexpected rates of serious adverse events related to the
therapy given its patient population.
-- On April 1, 2008, the final six-month results of the Phase II SEISMIC
Trial of MyoCell in Europe, was presented during the clinical trial
sessions at the American College of Cardiology. These results suggested
that MyoCell is a safe and potentially effective alternative treatment
to standard medical therapy alone for improving heart function among
patients with previously implanted cardiac devices who are experiencing
congestive heart failure.
-- Bioheart initiated its patient registry clinical trial protocol for
MyoCell with MyoCath(R) Injection Catheter delivery in Korea, Singapore
and Switzerland, adding to the number of patients enrolled and
commitment to purchase Bioheart catheters for research purposes.
Other Business Highlights
-- On March 17, 2008, the Company was awarded a U.S. Patent for a method
to repair damaged myocardium (heart tissue) by a combination of cell
transplantation and electrostimulation. The award of this patent brings
to more than 100 the number of related patents and patents pending to
which the Company holds rights. The patent covers methods for repairing
damaged heart tissue by providing electrostimulation to patient-derived
myogenic cells either in the laboratory, while the cells are expanding,
or after the cells are implanted into the damaged areas of the
-- The May 2008 issue of Cath Lab Digest featured an article on MyoCell
Therapy and the SEISMIC Trial and an interview with Warren Sherman, MD,
Director, Cardiac Cell-based Endovascular Therapies, Columbia
University Medical Center, New York, New York and Principal
Investigator of the MYOHEART Trial and the Phase II/III MARVEL Trial.
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.
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.
- Financial Tables on Following Pages -
Bioheart, Inc. and Subsidiaries
Consolidated Balance Sheets
March 31, December 31,
(Unaudited) (Derived from
Cash and cash equivalents $4,783,789 $5,492,157
Receivables 24,605 52,642
Inventory 390,074 372,054
Prepaid expenses and other current assets 2,782,159 261,030
Total current assets 7,980,627 6,177,883
Property and equipment, net 416,438 444,506
Deferred offering costs - 3,484,070
Deferred loan costs, net 593,944 1,146,716
Other assets 68,854 71,148
Total assets $9,059,863 $11,324,323
LIABILITIES AND SHAREHOLDERS' DEFICIT
Accounts payable $2,178,068 $2,134,256
Accrued expenses 4,296,348 4,511,775
Deferred revenue 485,786 547,286
Notes payable - current 6,725,374 6,671,112
Total current liabilities 13,685,576 13,864,429
Deferred rent 18,856 21,426
Note payable - long term 2,491,199 2,943,432
Total liabilities 16,195,631 16,829,287
Commitments and contingencies
Preferred stock ($0.001 par value)
5,000,000 shares authorized; none
issued and outstanding - -
Common stock ($0.001 par value) 50,000,000
shares authorized; 14,447,138 and
13,347,138 shares issued and
outstanding as of March 31, 2008
and December 31, 2007, respectively 14,447 13,347
Additional paid-in capital 78,720,440 77,061,296
Deficit accumulated during the
development stage (85,870,655) (82,579,607)
Total shareholders' deficit (7,135,768) (5,504,964)
Total liabilities and shareholders'
deficit $9,059,863 $11,324,323
Bioheart, Inc. and Subsidiaries
Consolidated Statements of Operations
For the Three-Month Period
Ended March 31,
Revenues $25,995 $13,805
Cost of sales 3,125 7,359
Gross profit 22,870 6,446
Development revenues 61,500 -
Research and development 1,358,057 1,400,590
Marketing, general and administrative 1,072,269 877,376
Depreciation and amortization 45,628 46,447
Total expenses 2,475,954 2,324,413
Loss from operations (2,391,584) (2,317,967)
Interest income 33,946 40,624
Interest expense (933,410) (561)
Net interest (expense) income (899,464) 40,063
Loss before income taxes (3,291,048) (2,277,904)
Income taxes - -
Net loss $(3,291,048) $(2,277,904)
Loss per share - basic and diluted $(0.24) $(0.18)
Weighted average shares outstanding - basic
and diluted 13,854,830 12,919,835
Contact: William Kline Lytham Partners, LLC
Chief Financial Officer Joe Diaz
Nicholas Burke Joe Dorame
VP - Financial Operations Robert Blum
(954) 835-1500 (602) 889-9700
|SOURCE Bioheart, Inc.|
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