The Company believes that it may have issued options to purchase common stock to certain of its employees, directors and consultants in California in violation of the registration or qualification provisions of applicable California securities laws. As a result, the Company intends to make a rescission offer to these persons. The Company will make this offer to all persons who have a continuing right to rescission, which it believes to include two persons. In the rescission offer, in accordance with California law, the Company will offer to repurchase all unexercised options issued to these persons at 77% of the option exercise price multiplied by the number of option shares, plus interest at the rate of 7% from the date the options were granted. Based upon the number of options that were subject to rescission as of December 31, 2009, assuming that all such options are tendered in the rescission offer, the Company estimated that its total rescission liability would be up to approximately $371,000. However, as the Company believes there is only a remote likelihood the rescission offer will be accepted by any of these persons in an amount that would result in a material expenditure by the Company, no liability was recorded as of June 30, 2011 or December 31, 2010.
On March 13, 2009, Judge Bernice Bouie Donald of the United States District Court for the Western District of Tennessee issued a Memorandum Opinion and Order in litigation brought against the Company by Dr. Peter K. Law and Cell Transplants Asia Limited (“CTAL”) (collectively, the “Plaintiffs”), captioned Peter K. Law, et al. v. Bioheart, Inc., No. 2:07-cv-2177 (the “Action”). The Action, which has been the subject of previous disclosures by the Company, was commenced on March 9, 2007, and asserted claims against the Company and Howard J. Leonhardt, individually, with respect to a license agreement entered into between Bioheart, Inc. and Cell Transplants International, LLC (“CTI”) on February 7, 2000 (the “Original License Agreement”). Pursuant to the License Agreement, among other things, CTI granted the Company a license to certain patents “related to heart muscle regeneration and angiogenesis for the life of the patents.” In July 2000, Bioheart and CTI, together with Dr. Law, executed an addendum to the License Agreement, which amended or superseded a number of the terms of the License Agreement (the “License Addendum”).
In their amended complaint, Dr. Law and CTAL asserted 14 breach of contract and related claims pertaining to the Original License Agreement and License Addendum, including, among others, claims that the Company had breached obligations to provide shares of Bioheart common stock to Dr. Law, pay royalties on “gross sales” of MyoCell, pay a $3 million milestone payment due upon Bioheart’s “commencement of a bona fide Phase II human clinical trial study that utilizes technology claimed under U.S. Patent No. 5,130,141 with F.D.A. approval in the United States,” and to refrain from sublicensing Plaintiffs’ patents. Plaintiffs also sought a declaratory judgment that the License Addendum was unenforceable due to a lack of consideration and/or economic duress. At the outset of the Action, the individual claim against Mr. Leonhardt was dismissed along with Plaintiffs’ claim for civil conspiracy, leaving 12 claims to be adjudicated.
The Company denied the material allegations of the amended complaint, denied it had any liability to Plaintiffs, and asserted a number of defenses to Plaintiffs’ claims, as well as counterclaims seeking a declaration that the License Addendum was a legally valid and binding agreement and asserting that Dr. Law and/or CTI had breached various obligations in the parties’ agreements.
Following the completion of discovery, the Action was tried to the Court, without a jury, from September 22-25, 2008.
On March 13, 2009, the Court rendered its decision in the Action, dismissing the amended complaint after finding that Plaintiffs had failed to establish any of their 12 remaining claims. With respect to Plaintiffs’ claim for the $3 million milestone payment, the Court found that the payment was “payable only to CTI,” not the Plaintiffs, and that CTI, a dissolved Tennessee limited liability company, had never been made a party to the Action and therefore was “not properly before the Court.” The Court also found that, even assuming Plaintiffs could assert a claim for the milestone payment on behalf of CTI, the payment was not due because “Bioheart’s MyoCell process does not utilize
BIOHEART, INC. AND SUBSIDIARIES
(a development stage company)
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2011
technology claimed under the ‘141 patent.” In addition, the Court found that Bioheart owed no royalties because it has not yet made any “gross sales” of MyoCell.
The Court found in Bioheart’s favor on its counterclaim seeking a declaration that the License Addendum was a valid and enforceable agreement and its counterclaim that Dr. Law breached his obligation under the License Addendum to provide Bioheart with “all pertinent and critical information” related to Bioheart’s filing of an IND application with the FDA. The Court awarded Bioheart nominal damages of $1.00 on the latter counterclaim, and dismissed Bioheart’s other counterclaims. Judgment upon the Memorandum Opinion and Order was entered on March 18, 2009.
Subsequent to the Court rendering its decision in the Action, the Plaintiffs filed a motion with the Court seeking reconsideration of its decision. The Company’s response was filed on April 20, 2009, and the Court’s response was received on October 15, 2009. The Plaintiffs’ motion to alter or amend was granted in partto clarify that Plaintiff failed to prove that the MyoCath catheter reads upon the claims of a patent other than the Schmidt catheter patent. Plaintiffs’ motion was otherwise denied.
A notice of appeal was to have been filed by November 16, 2009, by Dr. Law. The appeal was not filed. The accrual made prior to November 16, 2009, to accommodate a judgment in favor of Dr. Law has been reversed.
The Company is subject to other legal proceedings that arise in the ordinary course of business. In the opinion of management, as of June 30, 2011, the amount of ultimate liability with respect to such matters, if any, in excess of applicable insurance coverage, is not likely to have a material impact on the Company’s business, financial position, consolidated results of operations or liquidity. However, as the outcome of litigation and other claims is difficult to predict significant changes in the estimated exposures could exist.
NOTE 14 – FAIR VALUE MEASUREMENT
The Company adopted the provisions of Accounting Standards Codification subtopic 825-10, Financial Instruments (“ASC 825-10”) on January 1, 2008. ASC 825-10 defines fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities required or permitted to be recorded at fair value, the Company considers the principal or most advantageous market in which it would transact and considers assumptions that market participants would use when pricing the asset or liability, such as inherent risk, transfer restrictions, and risk of nonperformance. ASC 825-10 establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 825-10 establishes three levels of inputs that may be used to measure fair value:
Level 1 - Quoted prices in active markets for identical assets or liabilities.
Level 2 - Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets with insufficient volume or infrequent transactions (less active markets); or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 - Unobservable inputs to the valuation methodology that are significant to the measurement of fair value of assets or liabilities.
To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, for disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is disclosed and is determined based on the lowest level input that is significant to the fair value measurement.
Upon adoption of ASC 825-10, there was no cumulative effect adjustment to beginning retained earnings and no impact on the consolidated financial statements.
The carrying value of the Company’s cash and cash equivalents, accounts receivable, accounts payable, short-term borrowings (Including convertible notes payable), and other current assets and liabilities approximate fair value because of their short-term maturity.
Items recorded or measured at fair value on a recurring basis in the accompanying consolidated financial statements consisted of the warrant liability, reset and debt derivative liabilities. Convertible notes were determined at market based on their short term historical conversions
| | | | | | | | | | | | | | | | |
| | Quoted Prices in Active Markets for Identical Instruments Level 1 | | | Significant Other Observable Inputs Level 2 | | | Significant Unobservable Inputs Level 3 | | | Assets at fair Value | |
Liabilities: | | | | | | | | | | | | | | | | |
Derivative liability | | $ | - | | | $ | - | | | $ | (221,313 | ) | | $ | (221,313 | ) |
| | | | | | | | | | | | | | | | |
Total | | $ | - | | | $ | - | | | $ | (221,313 | ) | | $ | (221,313 | ) |
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BIOHEART, INC. AND SUBSIDIARIES
(a development stage company)
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2011
The following table provides a summary of changes in fair value of the Company’s Level 3 financial liabilities as of June 30, 2011:
| | | | |
| | Derivative Liability | |
Balance, December 31, 2010 | | $ | - | |
Total (gains) losses | | | | |
Initial fair value of debt derivative at note issuance | | | 335,406 | |
Mark-to-market at June 30, 2010: | | | | |
Embedded debt derivative | | | (92,001 | ) |
Transfers out of Level 3 upon conversion and settlement of notes | | | (22,092 | ) |
| | | | |
Balance, June 30, 2011 | | $ | 221,313 | |
| | | | |
Net Gain for the period included in earnings relating to the liabilities held at June 30, 2011 | | $
|
92,001 |
|
NOTE 15 – SUBSEQUENT EVENTS
Loan Agreement Amendment
On July 7, 2011, the Company and BlueCrest Venture Finance Master Fund Limited (“BlueCrest”) entered into an Amendment to Loan and Security Agreement, amending that certain loan from BlueCrest to the Company originated as of May 31, 2007 (the “Loan”). The outstanding principal amount of the Loan as of July 7, 2011 was $1,565,643.10. On July 8, 2011, BlueCrest agreed with the Company and Greystone Capital Partners (“Greystone”) to split the note evidencing the Loan into two notes aggregating the outstanding principal balance, with the new note being in the principal amount of $140,380.21 (the “New Note”). The New Note was assigned to Greystone in consideration for a payment by them to BlueCrest of $140,380.21, and modified.
The New Note is a subordinated convertible note bearing interest at the rate of 8% per annum, payable at maturity. The New Note is convertible into common stock of the Company at a price that is 50% less than the average of the three (3) lowest closing prices for the Company’s common stock for the ten (10) trading days prior to the Lenders’ election to exercise its conversion right; provided, however, that if the Company engages in a financing transaction that provides for a pricing discount that is greater than 50%, then the discount allowed to Greyston will be increased to such greater discount percentage.
In July 2011, the Company issued an aggregate of3,829,001 shares of our common stock in connection with the conversion of $140,380.21 of the July 8, 2011 convertible note.
On August 3, 2011, the Company and BlueCrest Venture Finance Master Fund Limited (“BlueCrest”) entered into an Amendment to Loan and Security Agreement, amending that certain loan from BlueCrest to the Company originated as of May 31, 2007 (the “Loan”). The outstanding principal amount of the Loan as of August 3, 2011 was $1,442,679.71. On August 3, 2011, BlueCrest agreed with the Company and Greystone Capital Partners (“Greystone”) to split the note evidencing the Loan into two notes aggregating the outstanding principal balance, with the new note being in the principal amount of $139,728.82 (the “New Note”). The New Note was assigned to Greystone in consideration for a payment by them to BlueCrest of $139,728.82, and modified.
The New Note is a subordinated convertible note bearing interest at the rate of 8% per annum, payable at maturity. The New Note is convertible into common stock of the Company at a price that is 50% less than the average of the three (3) lowest closing prices for the Company’s common stock for the ten (10) trading days prior to the Lenders’ election to exercise its conversion right; provided, however, that if the Company engages in a financing transaction that provides for a pricing discount that is greater than 50%, then the discount allowed to Greystone will be increased to such greater discount percentage.
In August 2011, the Company issued an aggregate of3,358,866 shares of our common stock in connection with the conversion of $139,728.82 of the August 3, 2011 convertible note.
Common Stock Issued
In July 2011, the Company issued an aggregate of 1,679,615 shares of our common stock in connection with the conversion of $80,000 of the Magna May 16, 2011 convertible note discussed in Item 5 Other Information.
In July 2011, the Company issued an aggregate of 2,594,458 shares of our common stock in connection with the conversion of the remaining balance of $99,728.82 of the Lotus June 15, 2011 convertible note discussed in Item 5 Other Information.
In July 2011, the Company issued an aggregate of 625,000 shares of our common stock in connection with the conversion of the Magna January 3, 2011convertible note discussed in Item 5 Other Information.
In July 2011, the Company issued an aggregate of 250,000 shares of our common stock in connection with Consulting Agreements.
On August 8, 2011 the Company received notice of conversion for the remaining balance of $30,000 of the Magna May 16, 2011 convertible note discussed in Item 5 Other Information. The Company issued an aggregate of 547,536 shares of our common stock in connection with the conversion.
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BIOHEART, INC. AND SUBSIDIARIES
(a development stage company)
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2011
Subscription Agreements
In July 2011, the Company sold an aggregate of 2,163,900 shares of the Company’s common stock and warrants to purchase 2,163,900 shares of the Company’s common stock for aggregate gross cash proceeds of $142,750. The warrants are (i) exercisable solely for cash at an exercise price of $0.06 to $0.09 per share, (ii) non-transferable for six months following issuance and (iii) exercisable, in whole or in part, at any time during the period commencing on the date that is six months and one day following the date of issuance and ending on the third year anniversary of the date of issuance.
In July 2011, the Company issued an additional 201,400 shares of the Company’s common stock and warrants to purchase 201,400 shares of the Company’s common stock in connection with Subscription Agreements received in June 2011. The warrants are (i) exercisable solely for cash at an exercise price of $0.08 per share, (ii) non-transferable for six months following issuance and (iii) exercisable, in whole or in part, at any time during the period commencing on the date that is six months and one day following the date of issuance and ending on the third year anniversary of the date of issuance.
In August 2011, the Company sold an aggregate of 2,676,780 shares of the Company’s common stock and warrants to purchase 2,676,780 shares of the Company’s common stock for aggregate gross cash proceeds of $205,000. The warrants are (i) exercisable solely for cash at an exercise price of $0.06 to $0.11 per share, (ii) non-transferable for six months following issuance and (iii) exercisable, in whole or in part, at any time during the period commencing on the date that is six months and one day following the date of issuance and ending on the third year anniversary of the date of issuance.
Issuance of Options and Warrants
Between July 1, 2011 and August 15, 2011, the Company issued options to purchase an aggregate of 304,762 shares of its common stock at a weighted average exercise price of $0.001 per share. The options vested immediately upon issuance and will expire on the tenth anniversary of the issuance date. As of August 15, 2011 an aggregate of 304,762 shares of common stock have been issued upon the exercise of the aforementioned options.
On August 12, 2011 the Company issued stock options to purchase an aggregate of 210,000 shares of common stock at an exercise price of $0.21 per share to certain members of the Company’s Board of Directors. The options vested immediately upon issuance and will expire on the tenth anniversary of the issuance date.
In August 12, 2011 the Company issue stock options to purchase an aggregate of 1,250,000 shares of common stock at an exercise price of $0.10 per share issued to certain of the Company’s employees. The options vest in 4 equal increments and expire on the tenth anniversary of the issuance date.
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| |
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations |
Unless otherwise indicated, references in this Quarterly Report on Form 10-Q to “we,” “us,” and “our” are to the Company. The following discussion and analysis by our management of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated interim financial statements and the accompanying related notes included in this quarterly report and our audited consolidated financial statements and related notes and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2010 filed with the Securities and Exchange Commission.
Cautionary Statement Regarding Forward-Looking Statements
This report may contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, and we intend that such forward-looking statements be subject to the safe harbors created thereby. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Any such forward-looking statements would be contained principally in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors.” Forward-looking statements include information concerning our possible or assumed future results of operations, business strategies, financing plans, competitive position, industry environment, potential growth opportunities and the effects of regulation. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions.
Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We discuss many of these risks in greater detail in “Risk Factors.” Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date of this report. You should read this report and the documents that we reference in this report and have filed as exhibits to the report completely and with the understanding that our actual future results may be materially different from what we expect. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
Additional information concerning these and other risks and uncertainties is contained in our filings with the Securities and Exchange Commission, including the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2010.
Our Ability To Continue as a Going Concern
Our independent registered public accounting firm has issued its report dated, May 10, 2011, in connection with the audit of our financial statements as of December 31, 2010, that included an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern. Our unaudited condensed consolidated financial statements as of June 30, 2011 have been prepared under the assumption that we will continue as a going concern. If we are not able to continue as a going concern, it is likely that holders of our common stock will lose all of their investment. Our financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Overview
We are committed to maintaining our leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Our goals are to regenerate damaged tissue, if possible, improve a patient’s quality of life, reduce hospitalizations and reduce overall health care costs.
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We were incorporated in the state of Florida in August 1999. Our principal executive offices are located at 13794 NW 4th Street, Suite 212, Sunrise, Florida 33325 and our telephone number is (954) 835-1500. Information about us is available on our corporate web site at www.bioheartinc.com. Information contained on the web site does not constitute part of, and is not incorporated by reference in, this report.
Biotechnology Product Candidates
Specific to biotechnology, we are focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. MyoCell is a clinical muscle-derived 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. Our most recent clinical trials of MyoCell include the SEISMIC Trial, a completed 40-patient, randomized, multicenter, controlled, Phase II-a study conducted in Europe and the MYOHEART Trial, a completed 20-patient, multicenter, Phase I dose-escalation trial conducted in the United States. We were approved by the U.S. Food and Drug Administration (the “FDA”) to proceed with a 330-patient, multicenter Phase II/III trial of MyoCell in North America and Europe (the “MARVEL Trial”). We completed the MyoCell implantation procedure on the first patient in the MARVEL Trial on October 24, 2007. Thus far, 20 patients, including 6 control patients, have been treated. Initial results for the 20 patients were released at the Heart Failure Society of American meeting in September, 2009, showing a significant (35%) improvement in the 6 minute walk for those patients who were treated, and no improvement for those who received a placebo. We are planning, on the basis of these results, to ask the FDA to consider the MARVEL Trial a pivotal trial (pivotal from Phase II to Phase III) and to reduce the number of patients in the trial to 150. The SEISMIC, MYOHEART and MARVEL Trials have been designed to test the safety and efficacy of MyoCell in treating patients with severe, chronic damage to the heart. Upon regulatory approval of MyoCell, we intend to generate revenue in the United States from the sale of MyoCell cell-culturing services for treatment of patients by qualified physicians. Abroad, we are identifying centers where it is already acceptable to use the Myocell treatment so that greater numbers of patients with this problem can have access to treatment.
We received approval from the FDA in July of 2009 to conduct a Phase I safety study on 15 patients of a combined therapy (Myocell with SDF-1), which we believe is the first approval of a study combining gene and cell therapies. We initially commenced work on this study, called the REGEN trial, during the first quarter of 2010. The Company suspended activity on the trial in 2010 while seeking additional funding necessary to conduct the trial. Work on the trial was reinitiated in 2011. Based on the results of the trial, we intend to either incorporate the combined treatment into the Marvel Trial, or continue with the Marvel Trial based on the use of Myocell alone.
In our pipeline, we have multiple product candidates for the treatment of heart damage, including autologous, adipose cell treatment for acute heart damage, chronic ischemia and critical limb ischemia.We hope to demonstrate that our various product candidates are safe and effective complements to existing therapies for chronic and acute heart damage as well as peripheral arterial disease.
MyoCell
MyoCell is a clinical therapy intended to improve cardiac function for those with congestive heart failure and is designed to be utilized months or even years after a patient has suffered severe heart damage due to a heart attack or other cause. We believe that MyoCell has the potential to become a leading treatment for severe, chronic damage to the heart due to its perceived ability to satisfy, at least in part, what we believe to be an unmet demand for more effective and/or more affordable therapies for chronic heart damage. MyoCell uses myoblasts, cells that are precursors to muscle cells, from the patient’s own body. The myoblasts are removed from a patient’s thigh muscle, isolated, grown through our proprietary cell culturing process, and injected directly in the scar tissue of a patient’s heart. A qualified physician performs this minimally invasive procedure using an endoventricular catheter. We entered into an agreement with a Johnson & Johnson company to use its NOGA® Cardiac Navigation System along with its MyoStar™ injection catheter for the delivery of MyoCell in the MARVEL Trial.
When injected into scar tissue within the heart wall, myoblasts have been shown to be capable of engrafting in the damaged tissue and differentiating into mature skeletal muscle cells. In a number of clinical and animal studies, the engrafted skeletal muscle cells have been shown to express various proteins that are important components of contractile function. By using myoblasts obtained from a patient’s own body, we believe MyoCell is able to avoid certain challenges currently faced by other types of cell-based clinical therapies including tissue rejection and instances of the cells differentiating into cells other than muscle. Although a number of therapies have proven to
31
improve the cardiac function of a damaged heart, no currently available treatment has demonstrated an ability to generate new muscle tissue within the scarred regions of a heart.
We believe the market for treating patients in NYHA Class II or NYHA Class III heart failure is significant. According to the AHA Statistics and the European Society of Cardiology Task Force for the Treatment of Chronic Heart Failure, in the United States and Europe there are approximately 5.2 million and 9.6 million, respectively, patients with heart failure. The AHA Statistics further indicate that, after heart failure is diagnosed, the one-year mortality rate is high, with one in five dying and that 80% of men and 70% of women under age 65 who have heart failure will die within eight years. We believe that approximately 60% of heart failure patients are in either NYHA Class II or NYHA Class III heart failure based upon a 1999 study entitled “Congestive Heart Failure Due to Diastolic or Systolic Dysfunction – Frequency and Patient Characteristics in an Ambulatory Setting” by Diller, PM, et. al.
MyoCath
The MyoCath was developed by Bioheart co-founder Robert Lashinski specifically for delivering new cells to damaged tissue. It is a deflecting tip needle injection catheter that has a larger needle which is 25 gauge for better flow rates and less leakage than systems that are 27 gauge. This larger needle allows for thicker compositions to be injected which helps with cell retention in the heart. Also, the MyoCath needle has more fluoroscopic brightness than the normally used nitinol needle, enabling superior visualization during the procedure. Seeing the needle well during injections enables the physician who is operating the catheter to pinpoint targeted areas more precisely, thus improving safety. The MyoCath competes well with other biological delivery systems on price and efficiency and allows the physician to utilize standard fluoroscopy and echo equipment found in every cath lab. The MyoCath is used to inject cells into cardiac tissue in therapeutic procedures to treat chronic heart ischemic and congestive heart failure. Inventory of MyoCath is limited as it is not currently in production. The Company is considering several contract manufacturers to produce additional inventory.
Critical Accounting Policies
Our discussion and analysis of our financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. While our critical accounting policies are described in Note 1 to our consolidated financial statements appearing elsewhere in this report, we believe the following policies are important to understanding and evaluating our reported financial results:
Stock-Based Compensation
The Company follows Accounting Standards Codification subtopic 718-10, Compensation (“ASC 718-10”) which requires that all share-based payments to both employees and non employees be recognized in the income statement based on their fair values.
Revenue Recognition
We recognize revenue in accordance with Accounting Standards Codification subtopic 605-10, Revenue Recognition (“ASC 605-10”) which requires that four basic criteria must be met before revenue can be recognized: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred; (3) the selling price is fixed and determinable; and (4) collectability is reasonably assured. Determination of criteria (3) and (4) are based on management’s judgments regarding the fixed nature of the selling prices of the products delivered and the collectability of those amounts. Provisions for discounts and rebates to customers, estimated returns and allowances, and other adjustments are provided for in the same period the related sales are recorded.
At the time of each transaction, management assesses whether the fee associated with the transaction is fixed or determinable and whether or not collection is reasonably assured. The assessment of whether the fee is fixed or determinable is based upon the payment terms of the transaction. If a significant portion of a fee is due after our
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normal payment terms or upon implementation or client acceptance, the fee is accounted for as not being fixed or determinable and revenue is recognized as the fees become due or after implementation or client acceptance has occurred. Collectability is assessed based on a number of factors, including past transaction history with the client and the creditworthiness of the client.
We account for Multiple-Element Arrangements under ASC 605-10 which incorporates Accounting Standards Codification subtopic 605-25, Multiple-Element Arrangements (“ASC 605-25”). ASC 605-25 addresses accounting for arrangements that may involve the delivery or performance of multiple products, services and/or rights to use assets.
Unbilled revenue is revenue that is recognized but is not currently billable to the customer pursuant to contractual terms. In general, such amounts become billable in accordance with predetermined payment schedules, but recognized as revenue as services are performed. Amounts included in unbilled revenue are expected to be collected within one year and are included within current assets.
Research and Development Activities
We account for research and development costs in accordance with Accounting Standards Codification subtopic 730-10, Research and Development (“ASC 730-10”). Under ASC 730-10, all research and development costs must be charged to expense as incurred. Accordingly, internal research and development costs are expensed as incurred. Third-party research and development costs are expensed when the contracted work has been performed or as milestone results have been achieved as defined under the applicable agreement. Company-sponsored research and development costs related to both present and future products are expensed in the period incurred
Results of Operations
We are a development stage company and our MyoCell product candidate has not received regulatory approval or generated any material revenues and is not expected to until 2012 if ever. We have generated substantial net losses and negative cash flow from operations since inception and anticipate incurring significant net losses and negative cash flows from operations for the foreseeable future as we continue clinical trials, undertake new clinical trials, apply for regulatory approvals, make capital expenditures, add information systems and personnel, make payments pursuant to our license agreements upon our achievement of certain milestones, continue development of additional product candidates using our technology, establish sales and marketing capabilities and incur the additional cost of operating as a public company.
Comparison of the Three Months Ended June 30, 2011 and 2010
Revenues
We recognized revenues of $3,495 in the three month period ended June 30, 2011 compared to revenues of $6,672 in the three month period ended June 30, 2010. The revenue in the three month period ended June 30, 2011 was generated mainly from the sale of MyoCath catheters.
Cost of Sales
Cost of sales was $139 in the three month period ended June 30, 2011 compared to $2,395 in the three month period ended June 30, 2011.
Research and Development
Research and development expenses were $107,569 in the three month period ended in June 30, 2011, a decrease of $570,252 from research and development expenses of $677,821 in 2010. The decrease was primarily attributable to a reduction in the amount of funds allocated to our clinical trials.
The timing and amount of our planned research and development expenditures is dependent on our ability to obtain additional financing. See “-Existing Capital Resources and Future Capital Requirements”and Item 1A. “Risk Factors - We will need to secure additional financing …” as filed with our Form 10-K with the Securities and Exchange Commission on May 10, 2011
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Marketing, General and Administrative
Marketing, general and administrative expenses were approximately $557,000 in the three month period ended June 30, 2011, an increase of $169,791 from marketing, general and administrative expenses of approximately $387,000 in 2010. The increase in marketing, general and administrative expenses is attributable, in part, to an increase in salaries & wages due to the hiring of the President and CEO for the company.
Gain on change in fair value of derivative liability
During the three months ended June 30, 2011, we issued unsecured convertible notes which creates a possibility of exceeding our common shares authorized when considering the number of possible shares that may be issuable to satisfy settlement provisions of these agreements after consideration of all existing instruments that could be settled in shares. As such we are required to record as a liability the fair value of the possible excess and mark to market each reporting period. During the three months ended June 30, 2011, we recorded a gain on change in the fair value of the derivative liability of $92,001.
Loss on settlement of debt
During the three month period ended June 30, 2011, we incurred a non cash loss on settlement of debt of $250,644 as compared to Nil for 2010. The loss is generated from the exchange of our BlueCrest Loan payments due with convertible notes.
Interest Expense
On June 1, 2007, we entered into the BlueCrest Loan and the Bank of America Loan, both in the principal amount of $5.0 million, with interest rates of 12.85% and 4.75% (prime plus 1.5%), respectively, at December 31, 2008. On August 20, 2008, we borrowed $1.0 million from a third party at an interest rate of 13.5% per annum. Interest expense primarily consists of interest incurred on the principal amount of these loans, accrued fees and interest earned by the guarantors of the Bank of America Loan, the amortization of related deferred loan costs and the amortization of the fair value of warrants issued in connection with the BlueCrest and Bank of America Loans. The fair value of the warrants originally issued in connection with the Bank of America Loan was amortized by the end of January 2008.
Interest expense was $334,039 in the three month period ended June 30, 2011 compared to interest expense of $52,913 in 2010, A increase of $281,126. During the three months ended June 30, 2011, we incurred a non cash interest expense of $158,441from our requirement to treat a portion of our convertible notes as derivative accounting. In addition, for 2011, we incurred additional non cash amortization of debt discounts associated with our new notes.
Comparison of the Six Months Ended June 30, 2011 and 2010
Revenues
We recognized revenues of $3,495 in the six month period ended June 30, 2011 compared to revenues of $36,466 in the six month period ended June 30, 2010. The revenue in the six month period ended June 30, 2011 was generated mainly from the sale of MyoCath catheters.
Cost of Sales
Cost of sales was $139 in the six month period ended June 30, 2011 compared to $16,799 in the six month period ended June 30, 2011.
Research and Development
Research and development expenses were $277,680 in the six month period ended in June 30, 2011, a decrease of $815,997 from research and development expenses of $1,093,677 in 2010. The decrease was primarily attributable to a reduction in the amount of funds allocated to our clinical trials.
The timing and amount of our planned research and development expenditures is dependent on our ability to obtain additional financing. See “-Existing Capital Resources and Future Capital Requirements”and Item 1A.
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“Risk Factors - We will need to secure additional financing …” as filed with our Form 10-K with the Securities and Exchange Commission on May 10, 2011
Marketing, General and Administrative
Marketing, general and administrative expenses were $1,047,014 in the six month period ended June 30, 2011, an increase of $233,047 from marketing, general and administrative expenses of $813,967 in 2010. The increase in marketing, general and administrative expenses is attributable, in part, to an increase in salaries & wages due to the hiring of the President and CEO for the company.
Gain on change in fair value of derivative liability
During the six months ended June 30, 2011, we issued unsecured convertible notes which creates a possibility of exceeding our common shares authorized when considering the number of possible shares that may be issuable to satisfy settlement provisions of these agreements after consideration of all existing instruments that could be settled in shares. As such we are required to record as a liability the fair value of the possible excess and mark to market each reporting period. During the three months ended June 30, 2011, we recorded a gain on change in the fair value of the derivative liability of $92,001.
Loss on settlement of debt
During the six month period ended June 30, 2011, we incurred a non cash loss on settlement of debt of $361,516 as compared to Nil for 2010. The loss is generated from the exchange of our BlueCrest Loan payments due with convertible notes.
Interest Expense
On June 1, 2007, we entered into the BlueCrest Loan and the Bank of America Loan, both in the principal amount of $5.0 million, with interest rates of 12.85% and 4.75% (prime plus 1.5%), respectively, at December 31, 2008. On August 20, 2008, we borrowed $1.0 million from a third party at an interest rate of 13.5% per annum. Interest expense primarily consists of interest incurred on the principal amount of these loans, accrued fees and interest earned by the guarantors of the Bank of America Loan, the amortization of related deferred loan costs and the amortization of the fair value of warrants issued in connection with the BlueCrest and Bank of America Loans. The fair value of the warrants originally issued in connection with the Bank of America Loan was amortized by the end of January 2008.
Interest expense was $902,200 in the six month period ended June 30, 2011 compared to interest expense of $736,022 in 2010. Interest incurred on the principal amount of our outstanding loans and interest and fees earned by the guarantors totaled $320,000 in the six month period ended June 30, 2011 and $525,000 in 2010. Amortization of debt discounts and amortization of the fair value of warrants issued in connection with the Note payable totaled $253,228 in the six month period ended June 30, 2011 compared to $210,967 in 2010.
Inflation
Our opinion is that inflation has not had, and is not expected to have, a material effect on our operations.
Climate Change
Our opinion is that neither climate change, nor governmental regulations related to climate change, have had, or are expected to have, any material effect on our operations.
Liquidity and Capital Resources
In the six month period ended June 30, 2011, we continued to finance our considerable operational cash needs with cash generated from financing activities.
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Operating Activities
Net cash used in operating activities was $704,152 in the six month period ended June 30, 2011 as compared to $965,027 of cash used in 2010.
Our use of cash for operations in the six months ended June 30, 2011 reflected a net loss generated during the period of approximately $2.5 million, adjusted for non-cash items such as stock-based compensation of $180,429, amortization of the fair value of warrants granted in connection with the Note payable of $159,372, amortization of debt discounts incurred in connection with the BlueCrest Loan and Bank of America and other Loans of $230,179, loss on settlement of debt of $361,516. A increase in prepaid and other current assets of $20,930 contributed to our use of operating cash in the six months ended June 30, 2011. The increase in prepaid expenses and other current assets was due mainly to the increase in prepaid stock based compensation. Partially offsetting these uses of cash was an increase in accrued expenses of $317,378 and accounts payable of $369,714.
Our use of cash for operations in the six months ended June 30, 2010 reflected a net loss generated during the period of $2.7 million, adjusted for non-cash items such as stock-based compensation of $94,596 amortization of the fair value of warrants granted in connection with the BlueCrest Loan and Bank of America loan of $140,536, amortization of loan costs incurred in connection with the BlueCrest Loan and Bank of America Loan of $66,154, equity instruments issued in settlement agreements of $567,529. A increase in prepaid and other current assets of $7,210 and an increase in accounts payable of $74,527 contributed to our use of operating cash in 2010. The increase in prepaid expenses and other current assets was due mainly to the increase in prepaid insurance. Partially offsetting these uses of cash were decreases in accrued expenses of $437,065.
Investing Activities
Net cash used in investing activities was $0 in the six month period ended June 30, 2011 and $0 in 2010.
Financing Activities
Net cash provided by financing activities was $735,039 in the six month period ended June 30, 2011 as compared to $894,868 in 2010.
In the six month period ended June 30, 2011 we sold, in a private placement, shares of common stock for aggregate net cash proceeds of $678,300.
Existing Capital Resources and Future Capital Requirements
Our MyoCell product candidate has not received regulatory approval or generated any material revenues. We do not expect to generate any material revenues or cash from sales of our MyoCell product candidate until commercialization of MyoCell, if ever. We have generated substantial net losses and negative cash flow from operations since inception and anticipate incurring significant net losses and negative cash flows from operations for the foreseeable future. Historically, we have relied on proceeds from the sale of our common stock and our incurrence of debt to provide the funds necessary to conduct our research and development activities and to meet our other cash needs.
At June 30, 2011 we had cash and cash equivalents totaling $34,185 however, our working capital deficit as of such date was approximately $12.38 million. Our independent registered public accounting firm has issued its report dated May 10, 2011 in connection with the audit of our consolidated financial statements as of December 31, 2010 that included an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not Applicable.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
We maintain disclosure controls and procedures, which are designed to ensure that information required to be disclosed in the reports we file or submit under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including our CEO and Controller, as appropriate, to allow timely decisions regarding required disclosure.
Under the supervision and with the participation of our management, including our CEO and Controller, an evaluation was performed on the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this quarterly report. Based on that evaluation, our management, including our CEO and Controller, concluded that our disclosure controls and procedures were ineffective as of the end of the period covered by this report due to the Company’s limited resources and limited number of employees. To mitigate the current limited resources and limited employees, we rely heavily on direct management oversight of transactions, along with the use of legal and outsourced accounting professionals. As we grow, we expect to increase our number of employees, which, we believe, will enable us to implement adequate segregation of duties within the internal control framework.
Changes In Internal Control Over Financial Reporting
There were no changes in the Company’s internal controls over financial reporting during the most recently completed fiscal quarter that have materially affected or are reasonably likely to materially affect the Company’s internal control over financial reporting.
PART II – OTHER INFORMATION
Item 1. Legal Proceedings
Our company is not involved in any material litigation and we are unaware of any threatened material litigation. However, the biotechnology and medical device industries have been characterized by extensive litigation regarding patents and other intellectual property rights. In addition, from time to time, we may become involved in litigation relating to claims arising from the ordinary course of our business.
Item 1A. Risk Factors
There have been no material changes in our risk factors from those disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2010.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Private Placement – Common Stock and Warrants
In April 2011, the Company sold an aggregate of 97,400 shares of the Company’s common stock and warrants to purchase 82,790 shares of the Company’s common stock for aggregate gross cash proceeds of $15,000. The warrants are (i) exercisable solely for cash at an exercise price of $0.15 per share, (ii) non-transferable for six months following issuance and (iii) exercisable, in whole or in part, at any time during the period commencing on the date that is six months and one day following the date of issuance and ending on the third year anniversary of the date of issuance.
In June 2011, the Company sold an aggregate of 1,611,110 shares of the Company’s common stock and warrants to purchase 1,611,110 shares of the Company’s common stock for aggregate gross cash proceeds of $145,000. The warrants are (i) exercisable solely for cash at an exercise price of $0.09 per share, (ii) non-transferable for six months following issuance and (iii) exercisable, in whole or in part, at any time during the period
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commencing on the date that is six months and one day following the date of issuance and ending on the third year anniversary of the date of issuance.
Subscription agreement
On January 23, 2011, Bioheart, Inc. (the “Company”) announced that it has entered into a subscription agreement with Anc Bio Holdings, Inc., a South Korean biomedical company, and a subscription agreement with one of its U.S. agents, Bioheart Florida, LLC for a $4 million equity investment, in the aggregate. Funding of the investment will be made ratably by them in installments with 10% immediately, followed by 40% within 45 days and the remaining 50% subject to certain conditions which the Company expects to satisfy in the next 90 days.
The aggregate number of shares of common stock anticipated to be issued in connection with the investment is 25,000,000 shares. The Company will also issue to the purchasers of common stock, warrants to purchase, in the aggregate, up to 12,500,000 shares of common stock. In connection with the common stock issuance, the subscribers received “piggyback” registration rights exercisable under certain circumstances more particularly set forth in the Registration Rights Agreement entered into with each investor.
Under the terms of the subscription agreements, the Company has agreed, among other things, that:
(a) Until April 20, 2011, the Company shall not initiate or support any action to increase the number of directors serving on the Company’s Board of Directors and, subject to unforeseen circumstances outside of the Company’s control (i.e., the death or disability of a board member), the Company will not initiate or support any change to the composition of the Board of Directors’ Committees without the investors’ prior consent;
(b) The Company will provide the Investors with an estimated use of proceeds prior to the first installment payment date and the Company will utilize not less than sixty percent (60%) of such proceeds for research and development costs and clinical trial costs;
(c) The proceeds may be used to attract and hire a new Company Chief Financial Officer and the Investors, or their designee(s) will have the right to participate in the interviewing of, and the selection of, that new Chief Financial Officer; and
(d) Until April 20, 2011, the Company shall not issue more than Two Hundred, Fifty Thousand (250,000) shares of the Company’s Common Stock in connection with any single transaction (other than shares that may be issued in connection with the conversion of the existing convertible promissory note into such shares of common stock by Magna Group, LLC).
(e) the Company has agreed that, following its receipt of the first installment payment, the Company will cause a vacancy on the Company’s Board of Directors to be filled by one person designated by ABH. Additionally, the Company agreed with ABH that it shall not call a meeting nor schedule a meeting of its shareholders to be held prior to April 20, 2011.
On January 23, 2011 the Company did receive the initial 10% and is currently engaged in discussions with the investors to determine new timing for the funding of the remaining installments. As of April 18, 2011, the second installment had not been received from either ABH or BF.
Accordingly, on April 18, 2011 the Company delivered a written notice of default and termination to each of ABH and BF, in respect of the Agreements. The notice stated that it was being given as a result of the breach by each of ABH and BF of their respective payment obligations under the Agreements. A copy of the notice of default was filed with the Company’s Current Report on Form 8-K filed with the SEC on April 22, 2011.
Each of the listed sales was exempt from registration in reliance upon Section 4(s) of the Securities Act of 1933, as amended (the “Securities Act”), for transactions by an issuer not involving a public offering. The offer and sale of such securities was made without general solicitation or advertising to “accredited investors” as defined in Rule 501(a) of Regulation D promulgated by the Securities Act.
Item 3. Defaults Upon Senior Securities
Not Applicable
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Item 4. Removed and Reserved
Item 5. Other Information
Increase to Authorized Common Stock
As of December 31, 2010, our Articles of Incorporation authorized us to issue up to 75,000,000 shares of common stock, par value $0.001 per share. The Board of Directors proposed, and on January 13, 2011 (the “Record Date”) the holders of a majority of the Company’s issued and outstanding voting common shares as of the Record Date approved, an increase in the number of authorized shares of the common stock from 75,000,000 shares to 195,000,000 shares. On January 21, 2011 the Company filed a 14C Information Statement with the Securities and Exchange Commission. Following approval by the Securities and Exchange Commission and upon the filing of the Certificate of Amendment to the Articles of Incorporation, the Company’s will be authorized to issue a total of 195,000,000 shares of common stock, par value of $0.001 per share, and 5,000,000 shares of preferred stock, par value $0.001 per share.
Approval of Option Issuance
In June 2011, the Board of Directors approved the issuance of stock options to purchase an aggregate of 1,750,000 shares of common stock at an exercise price of $0.10 per share issued to certain of the Company’s employees. The options will vest in 4 equal increments and will expire on the tenth anniversary of the issuance date.
Loan agreement amendment
On December 31, 2009, the Company and BlueCrest Venture Finance Master Fund Limited (“BlueCrest”) entered into an Amendment to Loan and Security Agreement, amending that certain loan from BlueCrest to the Company originated as of May 31, 2007 (the “Loan”). The outstanding principal amount of the Loan as of December 31, 2010 was $2,276,543.03. On January 7, 2011, BlueCrest agreed with the Company and Magna Group, LLC (“Magna”) to split the note evidencing the Loan into two notes aggregating the outstanding principal balance, with the new note being in the principal amount of $139,729.82 (the “New Note”). The New Note was assigned to Magna in consideration for a payment by them to BlueCrest of $139,729.82, and modified. Additionally, Magna purchased a $25,000 convertible note from the Company (the “Convertible Note”).
The loans evidenced by the New Note and Convertible Note are in the nature of convertible debt evidenced by two unsecured convertible promissory notes, each bearing interest at the rate of 8% per annum, payable at maturity and each convertible into common stock of the Company at a price that is 50% less than the average of the closing prices for the Company’s shares for the five (5) days prior to the Lenders’ election to exercise its conversion right.
| |
• | In January 2011, we issued an aggregate of 538,542 shares of our common stock in connection with the conversion of $87,729 of the convertible note. |
| |
• | In February 2011, we issued an aggregate of 421,392 shares of our common stock in connection with the conversion of the remaining balance of $52,000 of the convertible note. |
On May 16, 2011, BlueCrest agreed with the Company and Magna Group, LLC (“Magna”) to again split the note evidencing the Loan into two notes aggregating the outstanding principal balance, with the new note being in the principal amount of $139,729.82 (the “New Note”). The New Note was assigned to Magna in consideration for a payment by them to BlueCrest of $139,729.82, and modified. Additionally, Magna purchased a $34,750 convertible note from the Company (the “Convertible Note”).
The loans evidenced by the New Note and Convertible Note are in the nature of convertible debt evidenced by two unsecured convertible promissory notes, each bearing interest at the rate of 8% per annum, payable at maturity and each convertible into common stock of the Company at a price that is 45% less than the average of the closing prices for the Company’s shares for the five (5) days prior to the Lenders’ election to exercise its conversion right.
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• | In June 2011, we issued an aggregate of 338,834 shares of our common stock in connection with the conversion of $29,728.82 of the convertible note. |
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On June 15, 2011, BlueCrest agreed with the Company and Lotus Funding Group, LLC (“Lotus”) to split the note evidencing the Loan into two notes aggregating the outstanding principal balance, with the new note being in the principal amount of $139,729.82 (the “New Note”). The New Note was assigned to Lotus in consideration for a payment by them to BlueCrest of $139,729.82, and modified.
The loan evidenced by the New Note is in the nature of convertible debt evidenced by an unsecured convertible promissory note, bearing interest at the rate of 8% per annum, payable at maturity and convertible into common stock of the Company at a price that is 50% less than the average of the closing prices for the Company’s shares for the five (5) days prior to the Lenders’ election to exercise its conversion right.
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• | In June 2011, we issued an aggregate of 836,775 shares of our common stock in connection with the conversion of $40,000 of the convertible note. |
Issuance of Shares of Common Stock
In May 2011, the Company issued an aggregate of 300,000 shares of our common stock in connection with Consulting Agreements.
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Item 6.
Exhibits
| | |
Exhibit No. | | Exhibit Description |
3.1(6) | | Amended and Restated Articles of Incorporation of the registrant, as amended |
3.2(9) | | Articles of Amendment to the Articles of Incorporation of the registrant |
3.3(8) | | Amended and Restated Bylaws |
4.1(5) | | Loan and Security Agreement, dated as of May 31, 2007 by and between BlueCrest Capital Finance, L.P. and the registrant |
4.2(12) | | Notice of Event of Default, from BlueCrest Venture Finance Master Fund Limited to the Company, dated January 28, 2009 |
4.3(12) | | Notice of Acceleration, from BlueCrest Venture Finance Master Fund Limited to the Company, dated February 2, 2009 |
4.4(13) | | Amendment to Loan and Security Agreement, between the Company and BlueCrest Venture Finance Master Fund Limited, dated as of April 2, 2009 |
4.5(13) | | Grant of Security Interest (Patents), between the Company and BlueCrest Venture Finance Master Fund Limited, dated as of April 2, 2009 |
4.6(13) | | Security Agreement (Intellectual Property), between the Company and BlueCrest Venture Finance Master Fund Limited, dated as of April 2, 2009 |
4.7(13) | | Subordination Agreement, by Hunton & Williams, LLP in favor of BlueCrest Venture Finance Master Fund Limited, entered into and effective April 2, 2009 |
4.8(13) | | Amended and Restated Promissory Note, dated April 2, 2009, by the Company to BlueCrest Venture Finance Master Fund Limited |
4.9(13) | | Warrant to purchase 1,315,542 shares of the registrant’s common stock, dated April 2, 2009, issued to BlueCrest Venture Finance Master Fund Limited |
4.10(14) | | Warrant to purchase 451,043 shares of the registrant’s common stock, dated April 2, 2009, issued to Rogers Telecommunications Limited |
4.11(14) | | Warrant to purchase 173,638 shares of the registrant’s common stock, dated April 2, 2009, issued to Hunton & Williams, LLP |
10.1**(1) | | 1999 Officers and Employees Stock Option Plan |
10.2**(1) | | 1999 Directors and Consultants Stock Option Plan |
10.2(a) | | |
10.3(1) | | Form of Option Agreement under 1999 Officers and Employees Stock Option Plan |
10.4(3) | | Form of Option Agreement under 1999 Directors and Consultants Stock Option Plan |
10.5**(4) | | Employment Letter Agreement between the registrant and Scott Bromley, dated August 24, 2006. |
10.6(1) | | Lease Agreement between the registrant and Sawgrass Business Plaza, LLC, as amended, dated November 14, 2006. |
10.7(1) | | Asset Purchase Agreement between the registrant and Advanced Cardiovascular Systems, Inc., dated June 24, 2003. |
10.8(4) | | Conditionally Exclusive License Agreement between the registrant, Dr. Peter Law and Cell Transplants International, LLC, dated February 7, 2000, as amended. |
10.9(4) | | Loan Guarantee, Payment and Security Agreement, dated as of June 1, 2007, by and between the registrant, Howard J. Leonhardt and Brenda Leonhardt |
10.10(4) | | Loan Guarantee, Payment and Security Agreement, dated as of June 1, 2007, by and between the registrant and William P. Murphy Jr., M.D. |
10.11(4) | | Loan Agreement, dated as of June 1, 2007, by and between the registrant and Bank of America, N.A. |
10.12(4) | | Warrant to purchase shares of the registrant's common stock issued to Howard J. Leonhardt and Brenda Leonhardt |
10.13(4) | | Warrant to purchase shares of the registrant's common stock issued to Howard J. Leonhardt and Brenda Leonhardt |
10.14(4) | | Warrant to purchase shares of the registrant's common stock issued to William P. Murphy Jr., M.D. |
10.15(4) | | Warrant to purchase shares of the registrant's common stock issued to the R&A Spencer Family Limited Partnership |
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10.16(4) | | Supply and License Agreement, dated June 7, 2007, by and between the registrant and BioLife Solutions, Inc.*** |
10.17(5) | | Warrant to purchase shares of the registrant's common stock issued to BlueCrest Capital Finance, L.P. |
10.18(6) | | Loan Guarantee, Payment and Security Agreement, dated as of September 12, 2007, by and between the registrant and Samuel S. Ahn, M.D. |
10.19(6) | | Loan Guarantee, Payment and Security Agreement, dated as of September 12, 2007, by and between the registrant and Dan Marino |
10.20(6) | | Warrant to purchase shares of the registrant's common stock issued to Samuel S. Ahn, M.D. |
10.21(6) | | Loan Guarantee, Payment and Security Agreement, dated as of September 19, 2007, by and between the registrant and Jason Taylor |
10.22(7) | | Loan Guarantee, Payment and Security Agreement, dated as of October 10, 2007, by and between the registrant and Howard and Brenda Leonhardt |
10.23(7) | | Warrant to purchase shares of the registrant's common stock issued to Howard and Brenda Leonhardt |
10.24(7) | | Second Amendment to Loan Guarantee, Payment and Security Agreement, dated as of October 10, 2007, by and between the registrant and Howard and Brenda Leonhardt |
10.25(7) | | Second Amendment to Loan Guarantee, Payment and Security Agreement, dated as of October 10, 2007, by and between the registrant and William P. Murphy, Jr., M.D. |
10.26**(10) | | Bioheart, Inc. Omnibus Equity Compensation Plan |
10.27(11) | | Form of Warrant Agreement for October 2008 Private Placement |
10.28(11) | | Form of Registration Rights Agreement for October 2008 Private Placement |
10.29(19) | | 10% Convertible Promissory Note Due July 23, 2010, in the amount of $20,000, payable to Dana Smith |
10.30(19) | | 10% Convertible Promissory Note Due July 23, 2010, in the amount of $100,000, payable to Bruce Meyers |
10.31(19) | | Registration Rights Agreement, dated July 23, 2009 |
10.32(19) | | Subordination Agreement, dated July 23, 2009 |
10.33(19) | | Note Purchase Agreement, dated July 23, 2009 |
10.34(19) | | Closing Confirmation of Conversion Election, dated July 23, 2009 |
10.35**(20) | | Amended and Restated 1999 Directors and Consultants Stock Option Plan |
10.36(21) | | Letter of Intent with Seaside National Bank and Trust, dated September 30, 2010. |
10.37(22) | | Loan Agreement with Seaside National Bank and Trust, dated October 25, 2010. |
10.38(22) | | Promissory Note with Seaside National Bank and Trust, dated October 25, 2010. |
10.39(22) | | Amended and Restated Loan and Security Agreement with BlueCrest Venture Finance Master Fund Limited, dated October 25, 2010. |
10.40(23) | | Form of Subscription Agreement, executed November 30, 2010. |
10.41(23) | | Form of Common Stock Purchase Warrant, issued November 30, 2010. |
10.42(23) | | Form of Registration Rights Agreement, dated November 30, 2010. |
10.43(24) | | Unsecured Convertible Promissory Note for $25,000, with Magna Group, LLC, dated January 3, 2011. |
10.44(24) | | Promissory Note for $139,728.82 with Magna Group, LLC, dated January 3, 2011. |
10.45(24) | | Securities Purchase Agreement with Magna Group, LLC, dated January 3, 2011. |
10.46(24) | | Subordination Agreement, dated January 3, 2011. |
10.47(24) | | Notice of Conversion Election, dated January 3, 2011. |
10.48(25) | | Unsecured Convertible Promissory Note for $34,750, with Magna Group, LLC, dated May 16, 2011. |
10.49(25) | | Promissory Note for $139,728.82 with Magna Group, LLC, dated May 16, 2011. |
10.50(25) | | Securities Purchase Agreement with Magna Group, LLC, dated May 16, 2011. |
10.51(25) | | Subordination Agreement, dated May 16, 2011. |
10.52(26) | | Promissory Note for $139,728.82 with Lotus Funding Group, LLC, dated June 15, 2011. |
10.53(26) | | Partial Assignment and Modification Agreement, dated June 15, 2011. |
10.54(26) | | Subordination Agreement, dated June 15, 2011. |
31.1* | | Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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| | |
32.1* | | Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
________________
| | |
* | | Filed herewith |
** | | Indicates management contract or compensatory plan. |
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(1) | | Incorporated by reference to the Company’s Form S-1 filed with the Securities and Exchange Commission on February 13, 2007 |
(2) | | Reserved |
(3) | | Incorporated by reference to Amendment No. 2 to the Company’s Form S-1 filed with the Securities and Exchange Commission on July 12, 2007 |
(4) | | Incorporated by reference to Amendment No. 3 to the Company’s Form S-1 filed with the Securities and Exchange |
| | Commission on August 9, 2007 |
(5) | | Incorporated by reference to Amendment No. 4 to the Company’s Form S-1 filed with the Securities and Exchange Commission on September 6, 2007 |
(6) | | Incorporated by reference to Amendment No. 5 to the Company’s Form S-1 filed with the Securities and Exchange Commission on October 1, 2007 |
(7) | | Incorporated by reference to Post-effective Amendment No. 1 to the Company’s Form S-1 filed with the Securities and Exchange Commission on October 11, 2007 |
(8) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 3, 2008 |
(9) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on August 8, 2008 |
(10) | | Incorporated by reference to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 14, 2008 |
(11) | | Incorporated by reference to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 14, 2008 |
(12) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 3, 2009 |
(13) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 8, 2009 |
(14) | | Incorporated by reference to the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 15, 2009 |
(15) | | Incorporated by reference to the Company’s Annual Report on Form 10-K/A filed with the Securities and Exchange Commission on April 30, 2009 |
(16) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 18, 2009 |
(17) | | Incorporated by reference to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 20, 2009 |
(18) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 9, 2009 |
(19) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 23, 2009 |
(20) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on August 3, 2009 |
(21) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on August 18, 2009 |
(22) | | Incorporated by reference to Exhibit 4.6 to the Company’s Post Effective Amendment to Registration Statement on Form S-8/A, filed with the Securities and Exchange Commission on April 28, 2010 |
(23) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the SEC on December 6, 2010. |
(24) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the SEC on January 12, 2011. |
(25) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the SEC on May 25, 2011. |
(26) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the SEC on June 21, 2011. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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| | Bioheart, Inc. | |
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Date: August 15, 2011 | By: | /s/Mike Tomas | |
| | Mike Tomas | |
| | Chief Executive Officer & President | |
44