We initially recorded payments received by us pursuant to our agreements with Advanced Cardiovascular Systems, Inc. (“ACS”), originally a subsidiary of Guidant Corporation and now d/b/a Abbott Vascular, a division of Abbott Laboratories, as deferred revenue. Revenues are recognized on a pro rata basis as the catheters are delivered pursuant to those agreements.
We initially recorded payments received by us pursuant to a clinical supply agreement entered into in August 2007 with BHK, Inc. (“BHK”) as deferred revenue. Revenues are recognized on a pro rata basis as the cell-culturing services are provided and are shown in development revenues. The costs associated with earning these revenues are expensed as incurred and are included in research and development expenses in our statements of operations. In February 2005, we entered into a joint venture agreement with Bioheart Korea, Inc., BHK’s predecessor entity, pursuant to which we and BHK agreed to create a joint venture company now known as Bioheart Manufacturing, Inc. As of December 31, 2008, the Company owned an 18% equity interest in Bioheart Manufacturing, Inc. In February 2009, the Company’s ownership interest in Bioheart Manufacturing, Inc. was reduced from 18% to approximately 6% as a result of an investment in Bioheart Manufacturing, Inc. by a third party.
Research and development expenditures, including payments to collaborative research partners, are charged to expense as incurred. We expense amounts paid to obtain patents or acquire licenses as the ultimate recoverability of the amounts paid is uncertain.
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 2010, 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.
We recognized revenues of $224,135 in the nine-month period ended September 30, 2009 compared to revenues of $49,771 in the nine-month period ended September 30, 2008. In the nine-month period ended September 30, 2009 all revenue generated was mainly from the shipment of MyoCath catheters.
In the nine-month period ended September 30, 2008, we recognized $97,000 in development revenues from cell-culturing services provided pursuant to the clinical supply agreement entered with BHK, Inc. No such revenues were recognized in the nine-month period ended September 30, 2009.
Cost of Sales
Cost of sales was $123,714 in the nine-month period ended September 30, 2009 compared to $10,962 in the nine-months ended September 30, 2008. The manufacturing cost per catheter sold in the nine-month periods ended September 30, 2009 and 2008 were approximately the same. However, a portion of the catheters sold in 2008 had no inventory cost as they had been written off in prior years.
Research and Development
Research and development expenses were $2,265,671 for the nine-month period ended September 30, 2009 compared to $4,994,552 in the nine-month period ended September 30, 2008, a decrease of $2,728,881. The decrease was primarily attributable to a reduction in the amount of sponsored research and a reduction in costs related to our SEISMIC, MYOHEART and MARVEL Trials.
The timing and amount of our planned research and development expenditures is dependent on our ability to obtain additional financing.
During the quarter, the Company received notification that approximately $630,000 in pending projects (Indiana University, University of Florida, Northwestern University, and other sites) were completed; however, the invoicing has not been received as of September 30, 2009. Accordingly, the Company has accrued approximately $630,000 for the completed contracts, which resulted in a charge to earnings during the quarter.
Marketing, General and Administrative
Marketing, general and administrative expenses were $1,666,477 for the nine-month period ended in September 30, 2009, compared to $4,684,063 in the nine-month period ended September 30, 2008, a decrease of $3,017,586. The decrease in marketing, general and administrative expenses is attributable, to a decrease in stock-based compensation expense, salaries & wages, legal fees and accounting fees.
Interest Income
Interest income consists of interest earned on our cash and cash equivalents. Interest income was $18 in the nine-months ended September 30, 2009 compared to interest income of $44,397 in the nine-month period ended September 30, 2008. The decrease in interest income was primarily attributable to lower cash balances in the nine-month period ended September 30, 2009, compared to the nine-month period ended September 30, 2008.
Interest Expense
Interest expense primarily consists of interest incurred on the principal amount of the BlueCrest and the Bank of America 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. Our debt carries interest rates ranging from 4.75% to 13.50% as of September 30, 2009.
Interest expense was $1,764,604 in the nine-month period ended September 30, 2009 compared to $1,922,766 in the nine-month period ended September 30, 2008. Interest incurred on the principal amount of our outstanding loans and interest and fees earned by the guarantors totaled $889,604 and $896,000 in the nine-month periods ended September 30, 2009 and 2008, respectively. Amortization of deferred loan costs and amortization of the fair value of warrants issued in connection with the BlueCrest and Bank of America Loans totaled $598,000 and $1,016,000 in the nine-month periods ended September 30, 2009 and 2008. The nine-month period ended September 30, 2009 also includes $270,000 of interest expense related to the discount associated with the convertible debt issued and converted during the period. The nine-month periods ended September 30, 2009 and 2008 also include $7,000 and $10,766, respectively, for interest related to insurance financing and credit card interest.
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Liquidity and Capital Resources
In 2009, we continue to finance our considerable operational cash needs with cash generated from financing activities.
Operating Activities
Net cash used in operating activities was $1,543,189 in the nine-months ended September 30, 2009 as compared to $9.0 million used in the nine months ended September 30, 2008.
Our use of cash for operations in the nine months ended September 30, 2009 reflected a net loss generated during the period of $5.7 million. However, our net loss was significantly offset by a decrease in prepaid expenses and other current assets of $648,589, an increase in accounts payable of $696,601 and an increases in accrued expenses of $1,497,152. The decrease in prepaid expenses and other current assets was due to the refund of upfront payments under an agreement with the contract research organization that we are utilizing for the MARVEL Trial. Accounts payable increased as we have sought to conserve cash until significant additional financing is obtained.
Our use of cash for operations in the nine months ended September 30, 2008 reflected a net loss generated during the period of $11.6 million and an increase in prepaid expenses and other current assets of $1.1 million. The increase in prepaid expenses and other current assets was due to upfront payments under an agreement with the contract research organization that we are utilizing for the MARVEL Trial. Partially offsetting these uses of cash were amortization of the fair value of warrants granted in connection with the BlueCrest Loan and Bank of America Loan of $664,734, an increase in accrued expenses and deferred rent of $803,130, an increase in accounts payable of $270,320, stock-based compensation of $1,199,029 and amortization of loan costs incurred in connection with the BlueCrest Loan and Bank of America Loan of $352,000.
Investing Activities
Net cash used in investing activities was $2,000 in the nine-month period ended September 30, 2009. Net cash used in investing activities was $18,000 in the nine-month period ended September 30, 2008. All of the cash utilized in investing activities in the nine-month period ended September 30, 2008 was related to the acquisition of property and equipment.
Financing Activities
Net cash provided by financing activities was $1,517,000 in the nine-month period ended September 30, 2009 compared to $5,012,000, in the nine-month period ended September 30, 2008.
In the nine-month period ended September 30, 2009, we received net proceeds of $298,001 in connection with the issuance of convertible debt and shares of common stock.
On February 22, 2008 we completed our IPO of common stock pursuant to which we sold 1,100,000 shares of common stock at a price per share of $5.25 for net proceeds of $1.45 million. The Consolidated Statement of Cash Flows for the nine months period ended September 30, 2008 reflects our receipt of approximately $5.4 million of “Proceeds from initial public offering of common stock, net.” The $5.4 million cash proceeds figure is approximately $3.95 million higher than the $1.45 million IPO net proceeds figure identified above due to our payment of $3.95 million of various offering expenses.
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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 2010, 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 September 30, 2009, we had cash and cash equivalents totaling $87,518; however, our working capital deficit as of such date was $12.7 million. Our independent registered public accounting firm issued its report dated April 7, 2009 in connection with the audit of our consolidated financial statements as of December 31, 2008 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.
Recent Accounting Pronouncements
Refer to Note 1.Organization and Summary of Significant Accounting Policies in the notes to our consolidated interim financial statements for a discussion of recent accounting pronouncements.
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Item 3. | | Quantitative and Qualitative Disclosures About Market Risk |
Interest Rate Risk
Our primary market risk exposure with respect to interest rates is changes in short-term interest rates in the U.S., particularly because certain of our debt arrangements represent floating rate debt and we are subject to interest rate risk. We do not use any interest rate risk management contracts to manage our fixed-to-floating ratio. The impact on our results of operations from a hypothetical 10% change in interest rates would not be significant.
The majority of our investments are expected to be in short-term debt securities. The primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive without significantly increasing risk. To reduce risk, we maintain our cash and cash equivalents in short-term interest-bearing instruments, including certificates of deposit and overnight funds. We do not have any derivative financial investments in our investment portfolio.
Item 4. | | Controls and Procedures
|
Disclosure Controls and Procedures
We have established disclosure controls and procedures to ensure that material information relating to us is made known to the officer who certifies our financial reports, as well as to other members of senior management and the Board of Directors.
We carried out an evaluation, under the supervision and with the participation of our management, including our Principal Executive Officer, as well as our Principal Financial and Accounting Officer, of the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on such evaluation, our Principal Executive Officer, as well as our Principal Financial and Accounting Officer concluded that, as of September 30, 2009, our disclosure controls and procedures were effective. The controls that management sought to identify and evaluate were those processes designed by, or under the supervision of, the Company’s Principal Financial Officer, or persons performing similar functions, and implemented by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles..
Our controls and procedures were designed at the reasonable assurance level. However, because of inherent limitations, any system of controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute, assurance of achieving the desired objectives of the control system. In addition, the design of a control system must reflect the fact that there are resource constraints, and management must apply its judgment in evaluating the benefits of controls relative to their costs. Further, no evaluation of controls and procedures can provide absolute assurance that all errors, control issues and instances of fraud will be prevented or detected. The design of any system of controls and procedures is also based in part on certain assumptions regarding the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
Changes In Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended September 30, 2009 that have materially affected, or are reasonably likely to materially affect, our internal control over financial
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reporting. We are continuing to evaluate internal controls over financial reporting and have improved our system for recording certain contractual obligations.
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PART II — OTHER INFORMATION
Item 1. Legal Proceedings
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 us 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 us, was commenced on March 9, 2007, and asserted claims against us 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 Original License Agreement, among other things, CTI granted us a license to certain patents “related to heart muscle regeneration and angiogenesis for the life of the patents.” In July 2000, we and CTI, together with Dr. Law, executed an addendum to the Original License Agreement, which amended or superseded a number of the terms of the Original 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 we 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 our “commencement of a bona fide Phase II human clinical trial study that utilizes technology claimed under U.S. Patent No. 5,130,141 with FDA 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.
We denied the material allegations of the amended complaint, denied we 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 technology claimed under the ‘141 patent.” In addition, the Court found that we owed no royalties because we have not yet made any “gross sales” of MyoCell.
The Court found in our favor on our counterclaim seeking a declaration that the License Addendum was a valid and enforceable agreement and our counterclaim that Dr. Law breached his obligation under the License Addendum to provide Bioheart with “all pertinent and critical information” related to our filing of an IND application with the FDA. The Court awarded us nominal damages of $1.00 on the latter counterclaim, and dismissed our other counterclaims. Judgment upon the Memorandum Opinion and Order was entered on March 18, 2009.
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Subsequent to the Court rendering its decision in the Action, the Plaintiffs filed a motion with the Court seeking reconsideration of its decision. Our response was filed on April 20, 2009, and the Court’s decision was received on October 15, 2009. The Plaintiffs’ motion to alter or amend was granted in part to clarify that Plaintiffs 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. The parties will have until November 16, 2009 to file a notice of appeal with the United States Court of Appeals for the Sixth Circuit.
There is a risk that the Court may find in favor of the Plaintiffs upon appeal. Our current cash reserves are not sufficient to satisfy a significant money judgment in favor of the Plaintiffs. The entry of such a judgment would also likely constitute a default under the BlueCrest Loan and Bank of America Loan and have a significant adverse impact on our financial condition, results of operations and MyoCell commercialization efforts.
Due to the uncertainty related to these proceedings, any potential loss cannot presently be determined.
As previously disclosed, on October 24, 2007, we completed the MyoCell implantation procedure on the first patient in our MARVEL Trial. As a result of the claim set forth in the litigation discussed above, we recorded an accrual for $3 million in the fourth quarter of 2007, which was included in accrued expenses as of March 31, 2009 and December 31, 2008.
Except as described above, we are not presently engaged in any material litigation and 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.
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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, 2008, as amended by Amendment No. 1 on Form 10-K/A.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Private Placement — Convertible Debt
In July 2009, Bruce Meyers and Dana Smith (jointly, the “Lenders”) funded a total $120,000 loan to the Company. The Loan was in the nature of convertible debt and was evidenced by an unsecured promissory note (the “Note”), that was convertible into common stock of the Company at a price that was 22.5% less than the average of the closing bid prices for the Company’s shares for the five (5) days prior to the Lenders’ election to exercise their conversion right under the Note. The Note was to bear interest at the rate of 10% per annum, with interest payable due at maturity. The terms sheet provides that all unpaid interest (and principal) will be due and payable on the date that is the earlier to occur of the first anniversary of the closing date of the Loan or the closing of a financing in an amount that is equal to or greater than $3.0 million that will satisfy the Company’s obligation under its loan with BlueCrest. However, the Lenders already elected to convert the entire amount of the Loan to shares of the Company’s common stock.
Accordingly, the aggregate number of unregistered and restricted shares of the Company’s common stock issued in connection with, and as a result of the conversion of, the Loan were 355,294 shares. The Company will have no obligation to file any registration statement with respect to the shares, except that the Lenders will have customary “piggyback” registration rights.
Private Placement — Common Stock and Warrants
In July 2009, the Company sold, in a private placement, an aggregate of 140,850 shares of the Company’s common stock and warrants to purchase 42,255 shares of the Company’s common stock for aggregate gross cash proceeds of $100,000. The warrants are (i) exercisable solely for cash at an exercise price of $0.85 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 2009, the Company sold, in a private placement, an aggregate of 618,850 shares of the Company’s common stock and warrants to purchase 185,655 shares of the Company’s common stock for aggregate gross cash proceeds of $351,000. The warrants are (i) exercisable solely for cash at an exercise price of $0.64 to $0.74 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 September 2009, the Company sold, in a private placement, an aggregate of 451,410 shares of the Company’s common stock and warrants to purchase 135,423 shares of the Company’s common stock for aggregate gross cash proceeds of $375,082. The warrants are (i) exercisable solely for cash at an exercise price of $0.73 to $1.97 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 October 2009, the Company sold, through the private placement, an aggregate of 224,770 shares of the Company’s common stock and warrants to purchase 67,431 shares of the Company’s common stock for aggregate gross cash proceeds of $305,120. The warrants are (i) exercisable solely for cash at an exercise price of $1.24 to $1.97 per share, (ii) non-transferable for six months following issuance and (iii) exercisable, in
39
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.
The PIPE was closed on October 31, 2009, with total capital raised of $3,887,032.
Item 5. Other Information
On August 12, 2009, the Board of Directors decided that several of its Directors join the Company’s executive management team. In addition to assuming the position of Chairman of the Company’s Board of Directors, Karl E. Groth, Ph.D., became the Chief Executive Officer; Peggy A. Farley became Chief Operating Officer; and Mark P. Borman became Chief Financial Officer. Howard Leonhardt, who resigned from the Board of Directors, continues as Chief Scientific and Technology Officer, and Chairman of the Scientific Advisory Board. Mr. Leonhardt is the Company’s founder.
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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 |
| 10.3(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 |
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Exhibit No.
| | | | Exhibit Description
|
|---|
| 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 |
| 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 |
| 31.1* | | | | Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
| 32.1* | | | | Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
| ** | | Indicates management contract or compensatory plan. |
| (1) | | Incorporated by reference to the Company’s Form S-1 filed with the Securities and Exchange Commission on February 13, 2007 |
| (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 |
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| (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 |
43
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.
| | | | | Bioheart, Inc. |
| | | | | |
| Date: November 13, 2009 | | | | By:/s/ Karl E. Groth, Ph.D. |
| | | | | Karl E. Groth, Ph.D.Chairman of the Board
and Chief Executive Officer |
44
INDEX OF EXHIBITS
Exhibit No.
| | | | Exhibit Description
|
|---|
| 31.1 | | | | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
| 31.2 | | | | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
| 32.1 | | | | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
| 32.2 | | | | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
