SUNRISE, Fla., July 30 /PRNewswire-FirstCall/ -- Bioheart, Inc., (Nasdaq: BHRT) a company committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and cardiovascular diseases, today announced financial results for the second quarter ended June 30, 2008.
Recent Clinical Highlights:
-- On July 24, 2008, we announced that the results of a preclinical study involving the injection of myoblasts modified to express stromal derived factor-1(alpha) protein (SDF-1) into the scar tissue of the myocardium of rats, which suggest improved heart function, were recently presented at two scientific meetings -- the International Society for Magnetic Resonance in Medicine (ISMRM) in Toronto, and the American Society of Gene Therapy Meeting (ASGT) in Boston.
-- The May 2008 issue of Cath Lab Digest featured an article on MyoCell(R) Clinical Cell Therapy, 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.
Recent Corporate Highlights:
-- On July 11, 2008 the Company announced that it secured worldwide non-exclusive distribution rights to the Bioheart 3370 Heart Failure Monitor, an interactive and simple-to-use at-home intelligent device designed specifically to improve available healthcare to patients outside hospitals who are suffering from heart failure. The device, manufactured by RTX Healthcare A/S (Denmark), has 510k market clearance from the U.S. Food and Drug Administration for marketing in the U.S. and CE mark approval for marketing in Europe and other countries that follow this mark.
-- On July 2, 2008, the Company announced it was added to the Russell Microcap Index after the Russell Investment Group reconstituted its comprehensive set of U.S. and global equity indexes on June 27, 2008.
-- On July 1, 2008 the Company's Board of Directors appointed Howard J. Leonhardt, Bioheart's co-founder, Chairman of the Board and Chief Technology Officer, to serve as Chief Executive Officer.
Revenues for the quarter ended June 30, 2008 were $16,786 compared to $194,609 in the second quarter of 2007. During the quarter, the Company also recognized $15,000 of development revenue for services performed under a clinical registry agreement. The Company reported a net loss for the second quarter of 2008 of $3.9 million, or $(0.27) per share, compared to a net loss of $2.8 million, or $(0.21) per share, for the same quarter last year. The Company ended the quarter with cash and cash equivalents totaling $1.9 million.
The increase in the Company's net loss in the second quarter of 2008 as compared to the second quarter of 2007 is primarily attributable to increased stock-based compensation and interest expense related to $10 million of debt incurred by the Company in June 2007.
Research and development expenses for the second quarter of 2008 were $1.5 million compared to $1.8 million in the second quarter last year. The primary focus of the Company's research and development activities during the quarter related to the MARVEL Trial. 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.
"Recently, we acquired the distribution rights to a cardiac monitoring device that will complement the potentially groundbreaking biologic therapies that we are developing," said Howard Leonhardt, Chairman and Chief Executive Officer of Bioheart, Inc. "We believe that this leading-edge device will help to accelerate our efforts to transition from a development stage research company to a fully operating product marketing company."
Mr. Leonhardt continued, "My background in the scientific development of medical devices, and my experience in working with strategic marketing partners to identify and penetrate targeted markets for those devices will serve us well at this important moment in the Company's history. This is an exciting time in the development of Bioheart and we look to the future with great enthusiasm."
About Bioheart, Inc.:
Bioheart, Inc. (Nasdaq: BHRT) is committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and cardiovascular diseases. Its goals are to improve a patient's quality of life and reduce health care costs and hospitalizations. Specific to biotechnology, Bioheart is 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(R), is an innovative clinical muscle-derived 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 growth proteins. For more information on Bioheart, visit http://www.bioheartinc.com.
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; 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 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 and its quarterly report on Form 10-Q for
the quarter ended March 31, 2008.
Financial Tables on Following Pages
Bioheart, Inc. and Subsidiaries
Consolidated Balance Sheets
June 30, December 31,
(Unaudited) (Derived from
Cash and cash equivalents $1,879,995 $5,492,157
Receivables 53,870 52,642
Inventory 375,832 372,054
Prepaid expenses and other current assets 2,328,441 261,030
Total current assets 4,638,138 6,177,883
Property and equipment, net 370,517 444,506
Deferred offering costs - 3,484,070
Deferred loan costs, net 662,928 1,146,716
Other assets 68,854 71,148
Total assets $5,740,437 $11,324,323
LIABILITIES AND SHAREHOLDERS' DEFICIT
Accounts payable $1,878,359 $2,134,256
Accrued expenses 4,436,731 4,511,775
Deferred revenue 485,786 547,286
Notes payable - current 6,781,397 6,671,112
Total current liabilities 13,582,273 13,864,429
Deferred rent 16,284 21,426
Note payable - long term 2,024,281 2,943,432
Total liabilities 15,622,838 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 June 30, 2008 and December 31, 2007,
respectively 14,447 13,347
Additional paid-in capital 79,835,158 77,061,296
Deficit accumulated during the
development stage (89,732,006) (82,579,607)
Total shareholders' deficit (9,882,401) (5,504,964)
Total liabilities and shareholders' deficit $5,740,437 $11,324,323
Bioheart, Inc. and Subsidiaries
Consolidated Statements of Operations
For the Three-Month For the Six-Month
Ended June 30, Ended June 30,
2008 2007 2008 2007
Revenues $16,786 $194,609 $42,781 $208,414
Cost of sales 4,521 26,661 7,646 34,021
Gross profit 12,265 167,948 35,135 174,393
Development revenues 15,000 - 76,500 -
development 1,477,634 1,785,661 2,835,691 3,186,251
and administrative 1,876,442 873,300 2,948,711 1,750,676
amortization 45,921 45,780 91,549 92,226
Total expenses 3,399,997 2,704,741 5,875,951 5,029,153
operations (3,372,732) (2,536,793) (5,764,316) (4,854,760)
Interest income 8,256 75,157 42,202 115,781
Interest expense (496,875) (300,801) (1,430,285) (301,362)
(expense) income (488,619) (225,644) (1,388,083) (185,581)
Loss before income
taxes (3,861,351) (2,762,437) (7,152,399) (5,040,341)
Income taxes - - - -
Net loss $(3,861,351) $(2,762,437) $(7,152,399) $(5,040,341)
Loss per share -
basic and diluted $(0.27) $(0.21) $(0.51) $(0.39)
Weighted average shares
outstanding - basic
and diluted 14,447,138 13,235,738 14,150,984 13,012,328
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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