UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2010
¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ___________ to _____________.
Commission file number 0-20713
ENTREMED, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 58-1959440 |
| (State or other jurisdiction of | (I.R.S. Employer Identification No.) |
| incorporation or organization) | |
9640 Medical Center Drive
Rockville, Maryland
(Address of principal executive offices)
20850
(Zip code)
(240) 864-2600
(Registrant’s telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
YES x NO ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
YES ¨ NO ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
| | | | | | | |
Large accelerated filer ¨ | | Accelerated filer ¨ | | Non-accelerated filer þ | | Smaller reporting company o |
Indicate by checkmark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
YES ¨ NO x
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the most recent practicable date.
| Class | | Outstanding at August 4, 2010 | |
| Common Stock $0.01 Par Value | | 9,629,768 | |
ENTREMED, INC.
Table of Contents
| | PAGE |
| | |
| PART I. FINANCIAL INFORMATION | |
| | |
| Item 1 — | Consolidated Financial Statements | 3 |
| | |
| Consolidated Balance Sheets as of | |
| June 30, 2010 (unaudited) and December 31, 2009 | 3 |
| | |
| Consolidated Statements of Operations for the | |
| Six Months Ended June 30, 2010 and 2009 (unaudited) | 4 |
| | |
| Consolidated Statements of Cash Flows for the | |
| Six Months Ended June 30, 2010 and 2009 (unaudited) | 5 |
| | |
| Notes to Consolidated Financial Statements (unaudited) | 6 |
| | |
| Item 2 — | Management’s Discussion and Analysis of | |
| | Financial Condition and Results of Operations | 15 |
| | | |
| Item 3 — | Quantitative and Qualitative Disclosures | |
| | About Market Risk | 24 |
| | | |
| Item 4 — | Controls and Procedures | 25 |
| | | |
| Part II. OTHER INFORMATION | |
| | | |
| Item 1 — | Legal Proceedings | 25 |
| | | |
| Item 1A – | Risk Factors | 25 |
| | | |
| Item 2 — | Unregistered Sales of Equity Securities and Use of Proceeds | 25 |
| | | |
| Item 3 — | Defaults upon Senior Securities | 26 |
| | | |
| Item 4 — | Reserved | 26 |
| | | |
| Item 5 — | Other Information | 26 |
| | | |
| Item 6 — | Exhibits | 26 |
| | | |
| SIGNATURES | 27 |
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This report contains certain forward-looking statements within the meaning of Section 27A of the Securities Exchange Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements also may be included in other statements that we make. All statements that are not descriptions of historical facts are forward-looking statements. These statements can generally be identified by the use of forward-looking terminology such as “believes,” “expects,” “intends,” “may,” “will,” “should,” or “anticipates” or similar terminology. These forward-looking statements include, among others, statements regarding the timing of our clinical trials, our cash position and future expenses, and our future revenues.
Our forward-looking statements are based on information available to us today, and we will not update these statements.
Actual results could differ materially from those currently anticipated due to a number of factors, including the risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on the Nasdaq Capital Market; the volatility of our common stock; risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; the failure to consummate a transaction to monetize our Thalomid® royalty stream for any reason, including our inability to obtain the required third-party consents; declines in actual sales of Thalomid® resulting in reduced royalty payments; risks associated with our product candidates; the early-stage products under development; results in preclinical models are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; success in the clinical development of any products; dependence on third parties; and risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks). Additional information about the factors and risks that could affect our business, financial condition and results of operations, are contained in our filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov.
PART I. FINANCIAL INFORMATION
ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS
EntreMed, Inc.
Consolidated Balance Sheets
(Unaudited)
| | | June 30, 2010 | | | December 31, 2009 | |
| | | (Unaudited) | | | | |
| ASSETS | | | | | | |
| Current assets: | | | | | | |
| Cash and cash equivalents | | $ | 7,992,917 | | | $ | 6,312,182 | |
| Short-term investments | | | 50,024 | | | | 54,071 | |
| Accounts receivable, net of allowance for doubtful accounts of | | | | | | | | |
| $72,145 at June 30, 2010 and December 31, 2009 | | | - | | | | 3,286,858 | |
| Prepaid expenses and other | | | 156,813 | | | | 220,925 | |
| Total current assets | | | 8,199,754 | | | | 9,874,036 | |
| | | | | | | | | |
| Property and equipment, net | | | 134,629 | | | | 171,498 | |
| Other assets | | | 9,215 | | | | 21,494 | |
| Total assets | | $ | 8,343,598 | | | $ | 10,067,028 | |
| | | | | | | | | |
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | | | | | | | | |
| Current liabilities: | | | | | | | | |
| Accounts payable | | $ | 1,290,029 | | | $ | 1,968,607 | |
| Accrued liabilities | | | 299,848 | | | | 745,183 | |
| Current portion of loan payable | | | 5,137,463 | | | | 8,555,404 | |
| Total current liabilities | | | 6,727,340 | | | | 11,269,194 | |
| | | | | | | | | |
| Loan payable, less current portion | | | - | | | | 723,814 | |
| | | | | | | | | |
| Total liabilities | | | 6,727,340 | | | | 11,993,008 | |
| | | | | | | | | |
| Commitments and contingencies | | | - | | | | - | |
| | | | | | | | | |
| Stockholders' equity (deficit): | | | | | | | | |
| Convertible preferred stock, $1.00 par value; | | | | | | | | |
| 5,000,000 shares authorized and 3,350,000 shares issued and | | | | | | | | |
| outstanding at June 30, 2010 and December 31, 2009 | | | | | | | | |
| (liquidation value - $33,500,000 at June 30, 2010 and December 31, 2009) | | | 3,350,000 | | | | 3,350,000 | |
| Common stock, $.01 par value: | | | | | | | | |
| 170,000,000 shares authorized at June 30, 2010 and December 31, 2009: | | | | | | | | |
| 9,630,141 and 8,061,040 shares issued and outstanding | | | | | | | | |
| at June 30, 2010 and December 31, 2009, respectively | | | 96,301 | | | | 80,610 | |
| Additional paid-in capital | | | 379,401,344 | | | | 368,804,067 | |
| Treasury stock, at cost: 79,545 shares held at June 30, 2010 and | | | | | | | | |
| December 31, 2009 | | | (8,034,244 | ) | | | (8,034,244 | ) |
| Accumulated deficit | | | (373,197,143 | ) | | | (366,126,413 | ) |
| Total stockholders' equity (deficit) | | | 1,616,258 | | | | (1,925,980 | ) |
| Total liabilities and stockholders' equity (deficit) | | $ | 8,343,598 | | | $ | 10,067,028 | |
See accompanying notes.
EntreMed, Inc.
Consolidated Statements of Operations
(Unaudited)
| | | Three Months Ended | | | Six Months Ended | |
| | | June 30, 2010 | | | June 30, 2009 | | | June 30, 2010 | | | June 30, 2009 | |
| | | | | | | | | | | | | |
| Revenues: | | | | | | | | | | | | |
| Royalties | | $ | - | | | $ | - | | | $ | - | | | $ | - | |
| Other | | | - | | | | - | | | | - | | | | - | |
| | | $ | - | | | $ | - | | | $ | - | | | $ | - | |
| | | | | | | | | | | | | | | | | |
| Costs and expenses: | | | | | | | | | | | | | | | | |
| Research and development | | | 1,011,128 | | | | 1,659,474 | | | | 1,855,081 | | | | 3,612,934 | |
| General and administrative | | | 770,679 | | | | 1,010,733 | | | | 1,821,904 | | | | 2,170,454 | |
| Acquired In-Process R&D | | | 3,000,000 | | | | - | | | | 3,000,000 | | | | - | |
| | | | 4,781,807 | | | | 2,670,207 | | | | 6,676,985 | | | | 5,783,388 | |
| | | | | | | | | | | | | | | | | |
| Investment income | | | - | | | | 18,744 | | | | - | | | | 68,931 | |
| Interest expense | | | (168,733 | ) | | | (399,730 | ) | | | (389,698 | ) | | | (853,491 | ) |
| Other income (expense) | | | 5,954 | | | | - | | | | (4 047 | ) | | | - | |
| | | | | | | | | | | | | | | | | |
| Net Loss | | | (4,944,586 | ) | | | (3,051,193 | ) | | | (7,070,730 | ) | | | (6,567,948 | ) |
| | | | | | | | | | | | | | | | | |
| Dividends on Series A convertible preferred stock | | | (251,250 | ) | | | (251,250 | ) | | | (502,500 | ) | | | (502,500 | ) |
| | | | | | | | | | | | | | | | | |
| Net loss attributable to common shareholders | | $ | (5,195,836 | ) | | $ | (3,302,443 | ) | | $ | (7,573,230 | ) | | $ | (7,070,448 | ) |
| | | | | | | | | | | | | | | | | |
| Net loss per share (basic and diluted) | | $ | (0.62 | ) | | $ | (0.46 | ) | | $ | (0.95 | ) | | $ | (0.98 | ) |
| Weighted average number of common shares | | | | | | | | | | | | | | | | |
| outstanding (basic and diluted) | | | 8,325,539 | | | | 7,180,917 | | | | 7,989,424 | | | | 7,180,400 | |
See accompanying notes.
EntreM,ed, Inc.
Consolidated Statements of Cash Flows
(Unaudited)
| | | SIX MONTH PERIOD ENDED JUNE 30, | |
| | | 2010 | | | 2009 | |
| CASH FLOWS FROM OPERATING ACTIVITIES | | | | | | |
| Net loss | | $ | (7,070,730 | ) | | $ | (6,567,948 | ) |
| Adjustments to reconcile net loss to net cash provided by (used in) operating | | | | | | | | |
| activities: | | | | | | | | |
| Depreciation and amortization | | | 38,564 | | | | 65,757 | |
| Write-off of in-process R&D | | | 3,000,000 | | | | - | |
| Amortization of discount on short-term investments | | | - | | | | (31,665 | ) |
| Stock-based compensation expense | | | 231,330 | | | | 240,450 | |
| Non-cash interest | | | 35,532 | | | | 76,516 | |
| Investment impairment loss | | | 4,047 | | | | - | |
| Changes in operating assets and liabilities: | | | | | | | | |
| Accounts receivable | | | 3,286,858 | | | | 3,862,302 | |
| Prepaid expenses and other | | | 64,112 | | | | 171,480 | |
| Deferred rent | | | - | | | | (20,763 | ) |
| Accounts payable | | | (678,578 | ) | | | (1,746,308 | ) |
| Accrued liabilities | | | (445,333 | ) | | | (1,453,289 | ) |
| Net cash used in operating activities | | | (1,534,198 | ) | | | (5,403,468 | ) |
| | | | | | | | | |
| CASH FLOWS FROM INVESTING ACTIVITIES | | | | | | | | |
| Purchases of short term investments | | | - | | | | (6,993,512 | ) |
| Maturities of short term investments | | | - | | | | 10,000,000 | |
| Unrealized loss on short term investments | | | | | | | (4,429 | ) |
| Purchases of furniture and equipment | | | (1,695 | ) | | | - | |
| Net cash (used in) provided by investing activities | | | (1,695 | ) | | | 3,002,059 | |
| | | | | | | | | |
| CASH FLOWS FROM FINANCING ACTIVITIES | | | | | | | | |
| Stock issuance costs | | | (80,017 | ) | | | (6,150 | ) |
| Repayment of loan | | | (4,165,026 | ) | | | (3,753,920 | ) |
| Net proceeds from sale of common stock | | | 7,461,671 | | | | - | |
| Net cash provided by (used in) financing activities | | | 3,216,628 | | | | (3,760,070 | ) |
| | | | | | | | | |
| Net increase (decrease) in cash and cash equivalents | | | 1,680,735 | | | | (6,161,479 | ) |
| Cash and cash equivalents at beginning of period | | | 6,312,182 | | | | 16,743,129 | |
| Cash and cash equivalents at end of period | | $ | 7,992,917 | | | $ | 10,581,650 | |
| | | | | | | | | |
| Supplemental disclosure of cash flow information: | | | | | | | | |
| Cash paid during the period for interest | | $ | 354,148 | | | $ | 776,975 | |
| | | | | | | | | |
| Non-cash investing activity: | | | | | | | | |
| Stock issued in connection with milestone payment related to acquisition of Miikana | | $ | 3,000,000 | | | $ | - | |
See accompanying notes.
ENTREMED, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2010 (unaudited)
The accompanying consolidated financial statements include the accounts of EntreMed, Inc. (the Company or EntreMed) and its wholly-owned subsidiary, Miikana Therapeutics, Inc. (Miikana). All inter-company balances and transactions have been eliminated in consolidation. The Company refers to EntreMed and its consolidated subsidiary.
The accompanying unaudited consolidated financial statements have been prepared in accordance with U. S. generally accepted accounting principles for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, such consolidated financial statements do not include all of the information and disclosures required by U. S. generally accepted accounting principles for complete consolidated financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three and six-month periods ended June 30, 2010 are not necessarily indicative of the results that may be expected for the year ending December 31, 2010. For further information, refer to our audited consolidated financial statements and footnotes thereto included in our Form 10-K for the year ended December 31, 2009.
On July 1, 2010, the Company affected a 1-for-11 reverse split of its common stock, which was authorized by its Board of Directors on June 9, 2010 (See Note 12, “Subsequent Events”). All common stock share and per share information in the unaudited interim condensed consolidated financial statements and notes thereto included in this report have been restated to reflect retrospective application of the reverse stock split, except for par value per share and the number of authorized shares, which were not affected by the reverse stock split.
Material subsequent events have been considered for disclosure and recognition through the filing date of these consolidated financial statements.
Liquidity Risks and Management’s Plans
The accompanying unaudited consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Based on current plans, the Company expects its current available cash and cash equivalents will meet its cash requirements through fiscal 2010. At June 30, 2010 the Company has operating and liquidity concerns and plans to continue to pursue opportunities to raise additional capital to fund its operating needs. Since inception, the Company has incurred significant losses from operations and has incurred an accumulated deficit of $373 million. The Company expects to continue to incur expenses, resulting in operating losses, for the foreseeable future due to, among other factors, its continuing clinical trials, planned future clinical trials, and other anticipated research and development activities.
The Company’s ability to continue as a going concern is dependent on its success at raising additional capital sufficient to meet its obligations on a timely basis, and to ultimately attain profitability. There is no assurance that the Company will raise capital sufficient to enable the Company to continue its operations for the next twelve months. If additional funds are raised by issuing equity securities, dilution to existing shareholders may result. There can be no assurance that adequate additional financing will be available to the Company on terms that it deems acceptable, if at all. In the event additional financing is not obtained, the Company will likely reduce general and administrative expenses and scale back or interrupt the clinical development of ENMD-2076 until it is able to obtain sufficient financing to do so.
These factors could significantly limit the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue in existence.
Revenue is recognized when all of the following criteria are met: 1) persuasive evidence of an arrangement exists, 2) delivery has occurred or services have been rendered, 3) the price to the buyer is fixed and determinable and 4) collectibility is reasonably assured. Royalty revenue is not recognized until it is realized.
In connection with the Company’s business plan to become a clinically-focused operation, accelerating the clinical development of ENMD-2076, with the objective to lower operating costs and preserve capital, the Company experienced workforce reductions in December 2008 and in December 2009 which in the aggregate resulted in the elimination of approximately seventy percent of the Company’s total positions across all areas of business. The Company incurred charges for severance and related benefits totaling $228,754 and $1,783,773 during the fourth quarters of 2009 and 2008, respectively. At December 31, 2009, $228,754 is included in accrued liabilities. There were no additional charges during 2010. The Company has accounted for this restructuring as prescribed by authoritative guidance.
A summary of changes in the accrued liabilities during the six months ended June 30, 2010, is as follows:
| | | R&D | | | G&A | | | | |
| | | Expenses | | | Expenses | | | | |
| Balance at December 31, 2009 | | | | | | | | $ | 228,754 | |
| Cash payments | | $ | (178,286 | ) | | $ | (44,395 | ) | | | (222,681 | ) |
| Balance at June 30, 2010 | | | | | | | | | | $ | 6,073 | |
Cumulative costs incurred with respect to the restructuring are $2,013,000, of which, approximately $1,067,000 have been expensed as general and administrative costs and $946,000 have been expensed as research and development costs. The Company did not incur additional costs during the six months ended June 30, 2010 and does not expect to incur additional costs in connection with these terminations.
| 4. | Recently Adopted Accounting Pronouncements |
In January 2010, the Financial Accounting Standards Board (FASB) issued new authoritative guidance related to fair value disclosures. The provisions of the guidance require an entity to: (i) disclose separately the amounts of significant transfers in and out of Level 1 and Level 2 fair value measurements and describe the reasons for the transfers and (ii) present separate information for Level 3 activity pertaining to gross purchases, sales, issuances, and settlements. The new guidance is effective for interim and annual reporting periods beginning after December 15, 2009, except for the gross basis reconciliation for the Level 3 fair value measurements, which is effective for fiscal years beginning after December 15, 2010. The adoption did not have a material impact on the Company’s financial position and results of operations, as it does not have any transfers between Level 1 and Level 2 fair value measurements.
In February 2010, the FASB issued an amendment to existing authoritative guidance which requires an entity that is an SEC filer to evaluate subsequent events through the date that the financial statements are issued and removes the requirement for an SEC filer to disclose a date, in both issued and revised financial statements, through which the filer had evaluated subsequent events. The adoption did not have an impact on the Company’s financial position and results of operations.
Short-term investments at June 30, 2010 consist of equity securities. The Company has classified these investments as available for sale. Such securities are carried at fair market value. The cost of securities sold is calculated using the specific identification method. Realized gains and losses and declines in value judged to be other than temporary on securities available for sale, if any, are included in operations. As a result of an increase in value during the three months ended June 30, 2010, realized gains of $5,954 were recorded for the three months ended June 30, 2010. An overall decline in value during the six months ended June 30, 2010, that is considered to be other than temporary, resulted in net realized losses of $4,047 for the six months ended June 30, 2010. There were no realized gains or losses for the six months ended June 30, 2009. Net unrealized losses of $4,328 were recorded for the six months ended June 30, 2009. Short-term investments are principally uninsured and subject to normal credit risk.
The following is a summary of available-for-sale securities at June 30, 2010:
| | | Available-for-Sale Securities | |
| | | Amortized | | | Gross Realized | | | Gross Realized | | | Estimated Fair Value (Net Carrying | |
| | | Cost | | | Gains | | | Losses | | | Amount) | |
| Equity Securities | | $ | 125,000 | | | $ | 5,954 | | | $ | (80,930 | ) | | $ | 50,024 | |
| | | | | | | | | | | | | | | | | |
| Total | | $ | 125,000 | | | $ | 5,954 | | | $ | (80,930 | ) | | $ | 50,024 | |
The following is a summary of available-for-sale securities at December 31, 2009:
| | | Available-for-Sale Securities | |
| | | Amortized | | | Gross Realized | | | Gross Realized | | | Estimated Fair Value (Net Carrying | |
| | | Cost | | | Gains | | | Losses | | | Amount) | |
| Equity Securities | | $ | 125,000 | | | $ | - | | | $ | (70,929 | ) | | $ | 54,071 | |
| | | | | | | | | | | | | | | | | |
| Total | | $ | 125,000 | | | $ | - | | | $ | (70,929 | ) | | $ | 54,071 | |
On September 12, 2007, EntreMed, Inc. and Miikana Therapeutics, Inc., its wholly-owned subsidiary, entered into a Loan and Security Agreement (“Loan Agreement”) with General Electric Capital Corporation (“GECC”), as agent, Merrill Lynch Capital and Oxford Finance Corporation (collectively, “the Lenders”). The Loan Agreement provides for (i) a term loan (“Term Loan”) issued by the Lenders to the Company in the aggregate amount of $20,000,000 and (ii) the issuance and sale to the Lenders of stock purchase warrants evidencing the Lenders’ right to acquire their respective pro rata share of 250,000 shares of common stock of the Company (“Warrants”).
The Term Loan will accrue interest in arrears at a fixed annual interest rate of 10.47% until the Term Loan is fully repaid. The Company paid interest of approximately $153,650 and $364,000 during the three months ended June 30, 2010 and 2009, respectively. The Company paid interest of approximately $354,150 and $777,000 during the six months ended June 30, 2010 and 2009, respectively.
The Company has the right to voluntarily prepay the Term Loan, in full or in part, upon five business days’ written notice to GECC. Under certain circumstances, the prepayment of the aggregate amount outstanding under the Term Loan triggers a prepayment penalty equal to: 1% on such prepayment amount if such prepayment is made after the two year anniversary of the closing date but on or before the Term Loan maturity date. The Loan Agreement contains customary events of default that permits GECC to accelerate the Company’s outstanding obligations if an event of default occurs and it is not cured within the applicable grace periods. The Loan Agreement also provides for automatic acceleration upon bankruptcy and other insolvency events.
The Term Loan was used for general corporate purposes and is secured by the personal property owned by the Company, except for any intellectual property owned by the Company. Notwithstanding the foregoing, the collateral for the Term Loan includes (i) all cash, royalty fees and other proceeds that consist of rights of payment or proceeds from the sale, licensing or other disposition of all or any part of, or rights in, the intellectual property and the Thalidomide Royalty Agreement and (ii) the Company’s rights under the Thalidomide Royalty Agreement.
The Loan Agreement contains customary affirmative and negative covenants. The Company was in compliance with such covenants as of June 30, 2010.
The Warrants are exercisable by the Lenders until September 12, 2012 at an exercise price of $22.00 per share (as adjusted to reflect the one-for-eleven reverse stock split, as further described in Note 12 to these Notes to the Consolidated Financial Statements). The fair value of the Warrants issued was $190,000, calculated using a Black-Scholes value of $.76 with an expected and contractual life of 5 years, an assumed volatility of 98%, and a risk-free interest rate of 4.11%. The value of the Warrants, and an upfront underwriting fee of $100,000 paid to one of the Lenders, are recorded as a discount on the loan and are amortized as interest expense over the life of the loan. The Company also incurred certain debt issuance costs that were deferred and are included in other assets in the Company’s balance sheet as of June 30, 2010 and December 31, 2009. Amortization of these fees and the discount results in an effective interest rate of 11.40%. Non-cash interest expense related to the amortization of debt issuance costs and debt discount was $15,079 and $35,829 for the three months ended June 30, 2010 and 2009, respectively. Non-cash interest expense related to the amortization of debt issuance costs and debt discount was $35,532 and $76,516 for the six months ended June 30, 2010 and 2009, respectively.
The carrying value and estimated fair value of debt, before discount, were approximately $5,146,000 and $5,196,000 respectively, at June 30, 2010. The fair value was estimated based on the quoted market price.
| 7. | Fair Value Measurement |
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (“the exit price”) in an orderly transaction between market participants at the measurement date. The authoritative guidance outlines a valuation framework and creates a fair value hierarchy in order to increase the consistency and comparability of fair value measurements and the related disclosures. In determining fair value, EntreMed primarily uses prices and other relevant information generated by market transactions involving identical or comparable assets (“market approach”). The Company has determined that the fair value measurements are in accordance with the guidance.
The guidance established a three-level hierarchy for fair value measurements that distinguishes between market participant assumptions developed based on market data obtained from sources independent of the reporting entity (“observable inputs”) and the reporting entity’s own assumptions about market participant assumptions developed based on the best information available in the circumstances (“unobservable inputs”). EntreMed currently does not have non-financial assets and non-financial liabilities that are required to be measured at fair value on a recurring basis.
There have been no transfers of assets or liabilities between the fair value measurement classifications.
The Company’s financial assets and liabilities are measured using inputs from the three levels of the fair value hierarchy, defined as follows:
| | · | Level 1 – Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that we have the ability to access at the measurement date. |
| | · | Level 2 – Inputs are quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted pries that are observable for the asset or liability (i.e., interest rates, yield curves, etc.), and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs). |
| | · | Level 3 – Unobservable inputs that reflect our own assumptions, based on the best information available, including our own data. |
In accordance with the fair value hierarchy described above, the following table shows the fair value of the Company’s financial assets and liabilities that are required to be measured at fair value as of June 30, 2010:
| | | | | | Fair Value Measurements at June 30, 2010 | |
| | | Total Carrying Value at | | | Quoted prices in active markets | | | Significant other observable inputs | | | Significant unobservable inputs | |
| | | June 30, 2010 | | | (Level 1) | | | (Level 2) | | | (Level 3) | |
| Cash equivalents | | $ | 2,105,868 | | | $ | 2,105,868 | | | $ | — | | | $ | — | |
| Available for sale securities* | | | 50,024 | | | | 50,024 | | | | — | | | | — | |
| | | | | | | | | | | | | | | | | |
* Realized losses related to available for sale securities are included in operations, as disclosed in Note 5.
| | | | | | Fair Value Measurements at December 31, 2009 | |
| | | Total Carrying Value at | | | Quoted prices in active markets | | | Significant other observable inputs | | | Significant unobservable inputs | |
| | | December 31, 2009 | | | (Level 1) | | | (Level 2) | | | (Level 3) | |
| Cash equivalents | | $ | 4,105,868 | | | $ | 4,105,868 | | | $ | — | | | $ | — | |
| Available for sale securities* | | | 54,051 | | | | 54,051 | | | | — | | | | — | |
| | | | | | | | | | | | | | | | | |
* Realized losses related to available for sale securities are included in operations, as disclosed in Note 5.
The Company’s Level 1 assets include money market instruments and equity securities with quoted prices in active markets.
On January 11, 2010, the Company consummated the issuance and sale of 284,090 shares of its common stock, par value $0.01 per share, to an institutional investor for an aggregate purchase price of $2,500,000. The offering was made pursuant to a stock purchase agreement dated as of January 8, 2010 between the Company and the investor.
On February 3, 2010, the Company consummated the issuance and sale of 349,650 shares of its common stock, par value $0.01 per share, to an institutional investor for an aggregate purchase price of $2,500,000. The offering was made pursuant to a stock purchase agreement dated as of February 3, 2010 between the Company and the investor.
On April 16, 2010, the Company consummated the issuance and sale of 526,500 shares of its common stock, par value $0.01 per share, to an institutional investor for an aggregate purchase price of $3,000,000. The offering was made pursuant to a stock purchase agreement dated as of April 16, 2010 between the Company and the investor.
| 9. | Share-Based Compensation |
The Company has adopted incentive and nonqualified stock option plans for executive, scientific and administrative personnel of the Company as well as outside directors and consultants, of which 314,120 shares remain available for grant under the Company’s 2001 Long-Term Incentive Plan as of June 30, 2010. There are 607,979 shares issuable under options previously granted under the plans and currently outstanding, with exercise prices ranging from $1.76 to $522.50. Options granted under the plans vest over periods varying from immediately to three years, are not transferable and generally expire ten years from the date of grant.
The Company records compensation expense associated with stock options and other equity-based compensation in accordance with provisions of authoritative guidance. Compensation costs are recognized based on a straight-line method over the requisite service period, which is generally the option vesting term of three years.
The Company’s net loss for the six months ended June 30, 2010 and June 30, 2009 includes compensation expense of $231,330 and $240,450, respectively, related to the Company’s share-based compensation awards. The compensation expense related to the Company’s share-based compensation arrangements is recorded as components of general and administrative expense and research and development expense, as follows:
| | | SIX MONTHS ENDED JUNE 30, | |
| | | 2010 | | | 2009 | |
| Research and development | | $ | 19,495 | | | $ | 80,793 | |
| General and administrative | | | 211,835 | | | | 159,657 | |
| Share-based compensation expense | | $ | 231,330 | | | $ | 240,450 | |
| Net share-based compensation expense, per common share: | | | | | | | | |
| Basic and diluted | | $ | 0.03 | | | $ | 0.03 | |
The Company uses the Black-Scholes-Merton valuation model to estimate the fair value of stock options granted to employees. Option valuation models, including Black-Scholes-Merton, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant date fair value of an award.
Following are the weighted-average assumptions used in valuing the stock options granted to employees during the six-month periods ended June 30, 2010 and 2009:
| | | SIX MONTH PERIOD ENDED JUNE 30, | |
| | | 2010 | | | 2009 | |
| Expected volatility | | | 97.50 | % | | | 78.02 | % |
| Risk-free interest rate | | | 2.38 | % | | | 2.08 | % |
| Expected term of option | | 5 years | | | 5 years | |
| Forfeiture rate* | | | 5.00 | % | | | 5.00 | % |
| Expected dividend yield | | | 0.00 | % | | | 0.00 | % |
* - Authoritative guidance requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. During the six-month periods ended June 30, 2010 and 2009, forfeitures were estimated at 5%.
The weighted average fair value of stock options granted during the six-month periods ended June 30, 2010 and 2009 was $5.50 and $01.10, respectively.
A summary of the Company’s stock option plans and of changes in options outstanding under the plans for the six months ended June 30, 2010, is as follows:
| | | Number of Options | | | Weighted Average Exercise Price | | |
| Outstanding at January 1, 2010 | | | 634,797 | | | $ | 60.49 | |
| Granted | | | 36,816 | | | $ | 7.37 | |
| Exercised | | | (5,874 | ) | | $ | 1.76 | |
| Expired | | | (55,180 | ) | | $ | 222.04 | |
| Forfeited | | | (2,580 | ) | | $ | 4.38 | |
| Outstanding at June 30, 2010 | | | 607,979 | | | $ | 43.41 | |
| Vested and expected to vest at June 30, 2010 | | | 605,742 | | | $ | 43.54 | |
| Exercisable at June 30, 2010 | | | 563,243 | | | $ | 46.61 | |
Cash received from option exercises under all share-based payment arrangements for the three and six months ended June 30, 2010 was $0 and $10,340, respectively. Cash received from option exercises for the three and six months ended June 30, 2009 was $10,000.
| 10. | Acquired In-Process R&D |
In January 2006, the Company acquired Miikana Therapeutics, a private biotechnology company. Pursuant to the merger agreement, based on the success of the acquired preclinical programs, the Company may pay up to an additional $18 million upon the achievement of certain clinical and regulatory milestones. Such additional payments will be made in cash or shares of stock at our option. The lead molecule in the Aurora Kinase Program, ENMD-2076, advanced into clinical development in 2008. ENMD-2076 is a selective kinase inhibitor with activity against Aurora A and angiogenic kinases linked to promoting cancer and inflammatory diseases. Dosing of the first patient in 2008 triggered a purchase price adjustment milestone of $2 million. Dosing of the first patient in a Phase 2 trial in April 2010 triggered an additional purchase price adjustment milestone of $3 million, resulting in $13 million of potential payments remaining that could be earned, as of June 30, 2010. In June 2008, 233,100 shares of common stock were issued and in June 2010, 403,550 shares of common stock were issued as consideration for the satisfaction of the two milestone payments. The additional payments of $2 million in 2008 and $3 million in 2010 were recorded to expense as in-process research and development since the research and development project related to the Aurora Kinase Program had not reached technical feasibility and has no future alternative use.
At December 31, 2009, the Company has $2.96 million unrecognized tax benefit which has no net balance sheet impact.
During the six months ended June 30, 2010, there were no material changes to the measurement of unrecognized tax benefits in various taxing jurisdictions. The Company recognizes interest and penalties related to uncertain tax positions as a component of income tax expense.
The tax returns for all years in the Company’s major tax jurisdictions are not settled as of January 1, 2010; no changes in settled tax years have occurred through June 30, 2010. Due to the existence of tax attribute carryforwards (which are currently offset by a full valuation allowance), the Company treats all years’ tax positions as unsettled due to the taxing authorities’ ability to modify these attributes.
Reverse Stock Split
At the Annual Meeting of Stockholders held on June 3, 2010, the Company’s stockholders approved a proposal to authorize the Board of Directors, in its discretion, to affect a reverse split of the Company’s outstanding common stock without further action by the stockholders. The primary objective in affecting the reverse split was to better enable the Company to maintain the listing of its common stock on the NASDAQ Capital Market. On June 9, 2010, the Board of Directors approved a 1-for-11 reverse split of the Company’s common stock and on July 1, 2010 at 8:00 am. Eastern time (the Effective Time), the reverse stock split became effective. As a result of the reverse stock split, each eleven shares of the common stock that were issued and outstanding or held in treasury at the Effective Time were automatically combined into one share. The reverse stock split reduced the number of issued and outstanding shares of common stock as of July 1, 2010 from approximately 105.9 million shares to approximately 9.6 million shares. No fractional shares were issued in connection with the reverse stock split. Stockholders who were entitled to fractional shares instead became entitled to receive a cash payment in lieu of receiving fractional shares equal to the fractional share interest multiplied by $0.40 (the per share closing price of the Company’s common stock as last reported on the NASDAQ Stock Market on June 30, 2010). The reverse stock split affected all of the holders of common stock uniformly. Shares of common stock underlying outstanding options and warrants were proportionately reduced and the exercise price of outstanding options and warrants was proportionately increased in accordance with the terms of the agreements governing such securities. All common stock share and per share information in the unaudited interim condensed consolidated financial statements and notes thereto included in this report have been restated to reflect retrospective application of the reverse stock split, except for par value per share and the number of authorized shares, which were not affected by the reverse stock split.
As of July 15, 2010, the Company maintained a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days and subsequently received a letter from the NASDAQ Stock Market stating that the Company has regained compliance with NASDAQ’s $1.00 minimum closing bid price requirement. References to numbers of shares, and share prices, in this Quarterly Report on Form 10-Q reflect the 1-for-11 reverse stock split.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
OVERVIEW
We are a clinical-stage pharmaceutical company focused on developing ENMD-2076, an Aurora A and angiogenic kinase inhibitor for the treatment of cancer. ENMD-2076 is currently in a Phase 2 study in ovarian cancer and Phase 1 studies in advanced cancers, multiple myeloma and leukemia. ENMD-2076 is a novel orally-active, Aurora A/angiogenic kinase inhibitor with potent activity against Aurora A and multiple tyrosine kinases linked to cancer and inflammatory diseases. ENMD-2076 is relatively selective for the Aurora A isoform in comparison to Aurora B. Aurora kinases are key regulators of the process of mitosis, or cell division, and are often over-expressed in human cancers. ENMD-2076 exerts its effects through multiple mechanisms of action, including antiproliferative activity and the inhibition of angiogenesis. ENMD-2076 has demonstrated significant, dose-dependent preclinical activity as a single agent, including tumor regression, in multiple xenograft models (e.g. breast, colon, leukemia), as well as activity towards ex vivo-treated human leukemia patient cells.
ENMD-2076 has received orphan drug designation for the treatment of ovarian cancer, multiple myeloma and acute myeloid leukemia (“AML”).
ENMD-2076 is our only program currently under active clinical evaluation. This prioritization allows us to direct the majority of our resources to the clinical development of ENMD-2076. However, we also own intellectual property for our other therapeutic candidates. So that we can continue to accelerate the development of ENMD-2076, we do not intend to initiate additional new studies for these programs unless additional significant financing becomes available to us. Our other therapeutic candidates include MKC-1, an oral cell-cycle inhibitor with activity against the mTOR pathway that has completed multiple Phase 2 clinical trials for cancer, and ENMD-1198, a novel antimitotic agent that has completed a Phase 1 study in advanced cancers. We also have an approved Investigational New Drug Application (IND) for the use of Panzem® in rheumatoid arthritis (RA) treatment. All of our candidates are multi-mechanism drugs that target disease cells and the blood vessels that nourish them, which we believe can be developed to be safe and convenient, and provide the potential for improved patient outcomes.
We have incurred substantial operating losses since our inception due in large part to expenditures for our research and development activities. At June 30, 2010, we had an accumulated deficit of $373 million. We expect to continue to incur expenses, resulting in operating losses, for the foreseeable future due to, among other factors, our continuing clinical trials, planned future clinical trials, and other anticipated research and development activities. Based on current plans, we expect our current available cash and cash equivalents to meet our cash requirements through fiscal 2010. At June 30, 2010, we have operating and liquidity concerns and plan to continue to pursue opportunities to raise additional capital to fund our operating needs. We have successfully completed three financings since December 31, 2009, increasing our net cash by approximately $7,400,000. We will require additional funding during the first quarter of fiscal 2011 to fund operations until such time, if ever, we become profitable. We will continue efforts to augment our cash and cash equivalent balances as of June 30, 2010 by pursuing other opportunities to raise capital, including strategic alliances or collaborative development opportunities with organizations that have capabilities and/or products that are complementary to our capabilities and products in order to continue the development of our potential product candidate that we intend to pursue to commercialization. However, there can be no assurance that adequate additional financing under such arrangements will be available to us on terms that we deem acceptable, if at all.
On January 11, 2010, we sold 284,090 shares of our common stock, par value $0.01 per share, to an institutional investor for an aggregate purchase price of $2,500,000. On February 3, 2010, we sold 349,650 shares of our common stock to the same institutional investor for an aggregate purchase price of $2,500,000. On April 16, 2010, we sold 526,500 shares of our common stock to the same institutional investor for an aggregate purchase price of $3,000,000. Our net proceeds from these three offerings were approximately $7.4 million. Additional funds raised by issuing equity securities may result in dilution to existing shareholders. If we fail to obtain additional capital when needed, we may be required to delay, scale back, or eliminate our clinical program.
On April 4, 2008, we received a letter from The NASDAQ Stock Market LLC ("NASDAQ") advising that for the previous 30 consecutive business days, the bid price of our common stock had closed below the minimum $1.00 per share requirement for continued inclusion on The NASDAQ Global Market. Failure to comply with this minimum bid price requirement, or any other listing standard applicable to issuers listed on The NASDAQ Global Market, by October 1, 2008, would result in our common stock being ineligible for quotation on The NASDAQ Global Market.
On September 22, 2008, we submitted an application to transfer the trading of our common stock to the NASDAQ Capital Market and our common stock commenced trading on The NASDAQ Capital Market on October 3, 2008 under the symbol “ENMD”.
NASDAQ suspended the enforcement of the minimum bid price rule, due to the current extraordinary market conditions, until July 20, 2009. Upon reinstatement of the NASDAQ rules on August 3, 2009, we had until January 15, 2010 to regain compliance with the minimum bid price standard. We did not regain compliance with the minimum bid price standard of the NASDAQ rules by January 15, 2010.
On January 19, 2010, we received a Staff Determination Letter from NASDAQ stating that we were not in compliance with the continued listing rules and that our Common Stock would be delisted unless we requested an appeal of such determination. On January 20, 2010, we filed an appeal of the Staff's determination to a NASDAQ Hearings Panel (the “Panel”), pursuant to the procedures set forth in the NASDAQ Marketplace Rules. The hearing request stayed the delisting of the Company’s securities pending the Panel's decision. On February 25, 2010, we met with the Panel providing them a plan of action, with the intention of returning to compliance with NASDAQ’s requirements. On March 23, 2010, we received a decision letter from the Panel granting our request to extend the compliance date for an additional 180 days or until July 16, 2010.
On July 1, 2010 at 8:00 a.m. Eastern time, we affected a 1-for-11 reverse split of our common stock, which was authorized by our stockholders at the Annual Meeting of Stockholders held in June 2010. The primary objective in affecting the reverse split was to better enable us to maintain the listing of our common stock on the NASDAQ Capital Market. The reverse stock split reduced the number of our issued and outstanding shares of common stock as of July 1, 2010 from approximately 105.9 million shares to approximately 9.6 million shares. The par value per share and the number of authorized shares of our common stock were not affected by the reverse stock split. All share and per-share information for our common stock included in this report, other than par value and number of authorized shares, have been restated to reflect retrospective application of the reverse stock split.
As of July 15, 2010, our stock had maintained a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days and, subsequently, we received a letter from the NASDAQ Stock Market stating that we had regained compliance with NASDAQ’s $1.00 minimum closing bid price requirement.
In addition to the $1.00 minimum closing bid price, we must continually maintain (1) stockholders’ equity of at least $2.5 million or (2) a minimum of $35 million in market value of our listed securities for ten consecutive trading days to be in compliance with the continued listing standards for The NASDAQ Capital Market. At June 30, 2010, our consolidated stockholders’ equity was approximately $1,616,000 and the market value of our listed securities was $42.4 million. There can be no assurance that we will be able to meet either of these listing standards in the future.
CRITICAL ACCOUNTING POLICIES AND THE USE OF ESTIMATES
The preparation of our consolidated financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. Our critical accounting policies, including the items in our consolidated financial statements requiring significant estimates and judgments, are as follows:
| | - | Going Concern - A fundamental principle of the preparation of financial statements in accordance with GAAP is the assumption that an entity will continue in existence as a going concern, which contemplates continuity of operations and the realization of assets and settlement of liabilities occurring in the ordinary course of business. This principle is applicable to all entities except for entities in liquidation or entities for which liquidation appears imminent. In accordance with this requirement, our policy is to prepare our consolidated financial statements on a going concern basis unless we intend to liquidate or have no other alternative but to liquidate. Based on current plans, we expect our current available cash and cash equivalents to meet our cash requirements through fiscal 2010. At June 30, 2010, we had operating and liquidity concerns and plan to continue to pursue opportunities to raise additional capital to fund our operating needs. While we have prepared our consolidated financial statements on a going concern basis, if we do not receive additional funding, our ability to continue as a going concern may be impacted. Our consolidated financial statements included in this Quarterly Report on Form 10-Q do not reflect any adjustments that might specifically result from the outcome of this uncertainty. |
| | - | Revenue Recognition - We recognize revenue in accordance with the provisions of authoritative guidance issued, whereby revenue is not recognized until it is realized. Revenue is recognized when all of the following criteria are met: 1) persuasive evidence of an arrangement exists, 2) delivery has occurred or services have been rendered, 3) the price to the buyer is fixed and determinable and 4) collectibility is reasonably assured. |
| | - | Royalty Revenue – Royalties from licenses are based on third-party sales and recorded as earned in accordance with contract terms, when third-party results are reliably measured and collectibility is reasonably assured. We expect that the majority of our 2010 revenues will be from royalties on the sale of Thalomid®, which we will recognize when we receive the royalty payment. In 2004, certain provisions of a purchase agreement dated June 14, 2001 by and between Bioventure Investments kft (“Bioventure”) and the Company were satisfied and, as a result, beginning in 2005 we became entitled to share in the royalty payments received by Royalty Pharma Finance Trust, successor to Bioventure, on annual Thalomid® sales above a certain threshold. Based on the licensing agreement royalty formula, annual royalty sharing commences with Thalomid® annual sales of approximately $225 million. |
| | - | We are also eligible to receive royalties from Oxford Biomedica, PLC based on a portion of the net sales of products developed for the treatment of ophthalmic (eye) diseases based in part on Endostatin. Under our original Endostatin license agreement with Children’s Medical Center Corporation, a portion of the royalties we receive from Oxford Biomedica are payable to CMCC. |
| | - | In the future, royalty payments, if any, will be recorded as revenue when received and/or when collectibility is reasonably assured. |
| | - | Research and Development - Research and development expenses consist primarily of compensation and other expenses related to research and development personnel, research collaborations, costs associated with preclinical testing and clinical trials of our product candidates, including the costs of manufacturing drug substance and drug product, regulatory maintenance costs, and facilities expenses. Research and development costs are expensed as incurred. |
| | - | Expenses for Clinical Trials – Expenses for clinical trials are incurred from planning through patient enrollment to reporting of the data. We estimate expenses incurred for clinical trials that are in process based on patient enrollment and based on clinical data collection and management. Costs that are associated with patient enrollment are recognized as each patient in the clinical trial completes the enrollment process. Estimated clinical trial costs related to enrollment can vary based on numerous factors, including expected number of patients in trials, the number of patients that do not complete participation in a trial, and when a patient drops out of a trial. Costs that are based on clinical data collection and management are recognized in the reporting period in which services are provided. In the event of early termination of a clinical trial, we would accrue an amount based on estimates of the remaining non-cancelable obligations associated with winding down the clinical trial. |
| | - | Stock-Based Compensation – All share-based payment transactions are recognized in the consolidated financial statements at their fair values. Using the straight-line expense attribution method over the requisite service period, which is generally the option vesting term of three years, share-based compensation expense recognized in the three and six months ended June 30, 2010 totaled $19,440 and $231,330, respectively. Share-based compensation expense recognized in the comparable periods in 2009 totaled $85,317 and $240,450, respectively. |
The determination of fair value of stock-based payment awards on the date of grant using the Black-Scholes model is affected by our stock price, as well as the input of other subjective assumptions. These assumptions include, but are not limited to, the expected forfeiture rate and expected term of stock options and our expected stock price volatility over the term of the awards. Changes in the assumptions can materially affect the fair value estimates.
Any future changes to our share-based compensation strategy or programs would likely affect the amount of compensation expense recognized.
RESULTS OF OPERATIONS
For the Three and Six Months Ended June 30, 2010 and June 30, 2009.
Revenues. There were no revenues recorded in the three and six-month periods ended June 30, 2010 and June 30, 2009. We do not expect to record revenue in 2010 until the fourth quarter. Our 2010 revenues, if any, will result from Celgene’s sale of Thalomid®. We earn royalties once sales of Thalomid exceed approximately $225 million annually, pursuant to a 2001 agreement with Royalty Pharma, as noted above. Thalomid® is distributed and sold by Celgene Corporation and/or its affiliates, and thus, we have no control over sales of Thalomid® or the amount, if any, of royalty payments we will receive.
Research and Development Expenses. Our research and development expenses for the three and six months ended June 30, 2010 totaled $1,011,000 and $1,855,000, respectively. Research and development expenses for the corresponding 2009 periods were $1,659,000 and $3,613,000, respectively.
Reflected in our R&D expenses totaling $1,011,000 for the three-month period ended June 30, 2010 are direct project costs of $722,000 for ENMD-2076, $22,000 for Panzem® oncology, $22,000 for ENMD-1198 and $7,000 for MKC-1. The 2009 research and development expenses for the comparable period included $1,134,000 for ENMD-2076, $17,000 for Panzem® oncology and $76,000 for MKC-1.Research and development expenses totaling $1,855,000 for the six-month period ended June 30, 2010 include direct project costs of $1,525,000 related to ENMD-2076, $50,000 related to Panzem® oncology and $34,000 related to ENMD-1198. Additionally, during the six-month period ended June 30, 2010, we wrote off approximately $268,000 of costs previously accrued for patients enrolled in MKC-1 clinical trials that wound down before all cycles of treatment were completed. The 2009 research and development expenses for the comparable period included $1,906,000 for ENMD-2076, $124,000 for Panzem®, $338,000 for MKC-1, and $94,000 for ENMD-1198. The decrease in research and development costs in the three and six-month periods ended June 30, 2010, as compared to same periods in 2009, reflects our continued focus on the clinical development of ENMD-2076 as we ceased clinical and manufacturing activities in our discontinued programs.
At June 30, 2010, accumulated direct project expenses for Panzem® oncology were $54,295,000; direct ENMD-1198 project expenses totaled $13,177,000; and, since acquired, accumulated direct project expenses for ENMD-2076 totaled $15,683,000 and for MKC-1, accumulated project expenses totaled $10,145,000. Our research and development expenses also include non-cash stock-based compensation totaling $9,000 and $19,000, respectively, for the three and six months ended June 30, 2010 and $24,000 and $81,000 for the respective corresponding 2009 periods. The decrease in stock-based compensation expense is related to fewer stock options granted in the six months ending June 30, 2010. The balance of our research and development expenditures includes facility costs and other departmental overhead, and expenditures related to the non-clinical support of our programs.
We expect our research and development expenses to increase in 2010 as a result of the initiation of the multi-center Phase 2 study with ENMD-2076 in patients with ovarian cancer. Six sites are participating in the study and are currently enrolling patients. We will continue to conduct research on ENMD-2076 in order to comply with stipulations made by the FDA, as well as to increase understanding of the mechanism of action and toxicity parameters of ENMD-2076 and its metabolites. Completion of clinical development may take several years or more, but the length of time generally varies substantially according to the type, complexity, novelty and intended use of a product candidate.
We estimate that clinical trials of the type we generally conduct are typically completed over the following timelines:
| CLINICAL PHASE | | ESTIMATED COMPLETION PERIOD |
| Phase I | | 1 Year |
| Phase II | | 1-2 Years |
| Phase III | | 2-4 Years |
The duration and the cost of clinical trials may vary significantly over the life of a project as a result of differences arising during the clinical trial protocol, including, among others, the following:
| | - | the number of patients that ultimately participate in the trial; |
| | - | the duration of patient participation in the study and follow-up that seems appropriate in view of the results; |
| | - | the number of clinical sites included in the trials; and |
| | - | the length of time required to enroll suitable patient subjects. |
We test our potential product candidates in numerous preclinical studies to identify indications for which they may be product candidates. We may conduct multiple clinical trials to cover a variety of indications for each product candidate. As we obtain results from trials, we may elect to discontinue clinical trials for certain product candidates or for certain indications in order to focus our resources on more promising product candidates or indications.
Our proprietary drug candidates have also not yet achieved FDA regulatory approval, which is required before we can market them as therapeutic products. In order to proceed to subsequent clinical trial stages and to ultimately achieve regulatory approval, the FDA must conclude that our clinical data establish safety and efficacy. Historically, the results from preclinical testing and early clinical trials have often not been predictive of results obtained in later clinical trials. A number of new drugs and biologics have shown promising results in clinical trials, but subsequently failed to establish sufficient safety and efficacy data to obtain necessary regulatory approvals.
We will be opportunistic about collaborative arrangements with third parties to complete the development and commercialization of our products. In the event that third parties take over the development process for one of our product candidates, the estimated completion date would largely be under the control of that third party rather than us. We cannot forecast with any degree of certainty which proprietary products or indications, if any, will be subject to future collaborative arrangements, in whole or in part, and how such arrangements would affect our capital requirements.
As a result of the uncertainties discussed above, among others, we are unable to estimate the duration and completion costs of our research and development projects. Our inability to complete our research and development projects in a timely manner or our failure to enter into collaborative agreements, when appropriate, could significantly increase our capital requirements and could adversely impact our liquidity. These uncertainties could force us to seek additional, external sources of financing from time to time in order to continue with our business strategy. There can be no assurance that we will be able to successfully access external sources of financing in the future. Our inability to raise additional capital, or to do so on terms reasonably acceptable to us, would jeopardize the future success of our business.
Research and development expenses consist primarily of compensation and other expenses related to research and development personnel and costs associated with internal and contract preclinical testing and clinical trials of our product candidates, including the costs of manufacturing drug substance and drug product, regulatory maintenance costs, and facilities expenses. Expenditures during the three and six months ended June 30, 2010 were specifically impacted by the following:
| | - | Outside Services – In the three-month period ended June 30, 2010, we expended $6,000 on outside service activities versus $136,000 in the same 2009 period. For the six-month period ended June 30, 2010 outside services are $11,000 compared to $321,000 for the same 2009 period. The decrease in 2010 as compared to 2009 continues to reflect the absence of utilizing outsourced services to conduct development of products from discontinued programs. |
| | - | Clinical Trial Costs – Clinical trial costs, which include clinical site fees, monitoring costs and data management costs, decreased to $445,000 in the three months ended June 30, 2010 from $565,000 in the three-month period ended June 30, 2009. Clinical trial costs for the six-month period ended June 30, 2010 decreased to $466,000 from $1,008,000 for the comparable 2009 period. The decrease relates primarily to our focus on the clinical development of ENMD-2076, reducing patient costs for cycles of treatment that were not completed in trials that have wound down in discontinued programs. |
| - | Contract Manufacturing Costs – The costs of manufacturing the material used in clinical trials for our product candidates is reflected in contract manufacturing. These costs include bulk manufacturing, encapsulation and fill and finish services, product release costs and storage fees. Contract manufacturing costs for the three months ended June 30, 2010 decreased by $85,000 to ($19,000) from $66,000 during the same period in 2009. For the six-month period ended June 30, 2010, manufacturing costs decreased to $150,000 from $223,000 for the comparable 2009 period. The decrease reflects the absence of encapsulation costs for ENMD-2076 that were incurred in 2009, plus a credit received in 2010 reflecting a reduction in the scope of previously contracted compatibility, formulation development and GMP manufacture of ENMD-2076. |
| | - | Personnel Costs – Personnel costs decreased to $315,000 in the three-month period ended June 30, 2010 from $507,000 in the corresponding 2009 period. For the six-month period, personnel costs decreased in 2010 to $660,000 from $1,132,000 for the corresponding 2009 period. The decrease is attributed to the elimination of three management positions in December 2009. |
| | - | Also reflected in our 2010 research and development expenses for the three-month period ended June 30, 2010 are patent costs of $94,000 and facility and related expenses of $51,000. In the corresponding 2009 period, these expenses totaled $87,000 and $143,000, respectively. For the six-month period ended June 30, 2010, patent costs were $197,000 and facility and related expenses were $108,000. In the corresponding 2009 period, these expenses totaled $256,000 and $375,000, respectively. |
General and Administrative Expenses. General and administrative expenses include compensation and other expenses related to finance, business development and administrative personnel, professional services and facilities.
General and administrative expenses decreased to $771,000 in the three-month period ended June 30, 2010 from $1,011,000 in the corresponding 2009 period. For the six-month period, general and administrative expenses decreased in 2010 to $1,822,000 from $2,170,000 for the corresponding 2009 period.
Interest Expense. Interest expense, which relates to a financing transaction with General Electric Capital Corporation (GECC) in September 2007, decreased to approximately $169,000 (including $15,079 of non-cash interest) in the three-month period ended June 30, 2010 from approximately $400,000 (including $35,829 of non-cash interest) in the corresponding 2009 period. For the six-month period, interest expense decreased in 2010 to approximately $390,000 (including $35,550 of non-cash interest) from approximately $854,000 (including $76,515 of non-cash interest) for the corresponding 2009 period.
Investment Income. Due to the absence of invested cash during the three and six-month periods ended June 30, 2010, we earned no investment income. Investment income in the three and six-month periods ended June 30, 2009 were $19,000 and $69,000, respectively.
Dividends on Series A Convertible Preferred Stock. The Consolidated Statement of Operations for the three and six-month periods ended June 30, 2010 and 2009 reflect a dividend of $251,250 and $502,500, respectively, relating to Series A Convertible Preferred Stock held by Celgene pursuant to a Securities Purchase Agreement dated December 31, 2002. The holders of Series A Preferred Stock accumulate dividends at an annual rate of 6% and will participate in dividends declared and paid on our common stock, if any. All accumulated dividends must be paid before any dividends may be declared or paid on the common stock. We have no plans to pay any dividends in the foreseeable future.
LIQUIDITY AND CAPITAL RESOURCES
To date, we have been engaged primarily in research and development activities. As a result, we have incurred and expect to continue to incur operating losses in 2010 and the foreseeable future before we commercialize any products. Based on our current plans, we expect our current available cash and cash equivalents to meet our cash requirements through fiscal 2010.
As of June 30, 2010, we have operating and liquidity concerns and plans to continue to pursue opportunities to raise additional capital to fund our operating needs. We did not include any adjustments to the consolidated financial statements included in this Quarterly Report on Form 10-Q to reflect the possible future effects that may result from the uncertainty of our ability to continue as a going concern because we believe that we will continue to be a financially sound and viable business, continuing to conduct clinical trials for, and further development of, ENMD-2076 and provide value to our shareholders.
We will require significant additional funding during the first quarter of fiscal 2011 to fund operations until such time, if ever, we become profitable. We intend to augment our cash and cash equivalent balances as of June 30, 2010 by selling additional equity securities when market conditions permit. We will also explore alternatives to raising capital by being opportunistic about other potential forms of capital infusion, including strategic alliances or collaborative development opportunities, engaging in one or more strategic transactions, monetizing non-core assets and/or other transactions that provide capital to further the development of ENMD-2076.
There can be no assurance that adequate additional financing under such arrangements will be available to us on terms that we deem acceptable, if at all. If additional funds are raised by issuing equity securities, dilution to existing shareholders may result. If we fail to obtain additional capital when needed, we may be required to scale back our Phase 2 plans for ENMD-2076. We also will consider additional actions to reduce our expenses.
In January 2006, we acquired Miikana Therapeutics, Inc., a private biotechnology company, in exchange for approximately 905,500 shares of our common stock and the assumption of certain obligations of Miikana. We acquired certain drug candidates in connection with the acquisition, including the lead molecule in the Aurora Kinase Program, ENMD-2076, which advanced into clinical development in 2008. ENMD-2076 is a kinase inhibitor with activity towards Aurora A and multiple other kinases linked to promoting cancer. Dosing of the first patient in ENMD-2076 trials triggered a milestone payment of $2 million to the former Miikana stockholders payable in stock or cash, at the Company’s discretion. In June 2008, 233,100 shares of common stock were issued to the former Miikana stockholders as consideration for the satisfaction of the milestone payment. In April 2010, dosing of the first patient in a Phase 2 trial for ENMD-2076 triggered an additional milestone payment of $3 million, payable in stock or cash, at the Company’s sole discretion. In June 2010, 403,550 shares of common stock were issued to the former Miikana stockholders as consideration for the satisfaction of the milestone payment. Under the terms of the merger agreement, the former Miikana stockholders may earn up to an additional $13 million of potential payments upon the satisfaction of additional clinical and regulatory milestones. We do not expect such additional milestones to be satisfied during 2010. Through the Miikana acquisition, we also acquired rights to MKC-1, a Phase 2 clinical candidate licensed from Roche by Miikana in April 2005. Under the terms of the agreement, Roche may be entitled to receive future payments upon successful attainment of certain clinical, regulatory and commercialization milestones; however, since ENMD-2076 is the only program currently under active clinical evaluation by the Company, we do not expect to trigger any of these milestone payments during fiscal 2010.
In September 2007, we entered into a $20 million term loan agreement with General Electric Capital Corporation (the “Term Loan”). The Term Loan accrues interest in arrears at a fixed annual rate of 10.47%. For additional information on the Term Loan, please see Note 6 of the Notes to the Consolidated Financial Statements included in this Quarterly Report on Form 10-Q.
At June 30, 2010, we had cash and short-term investments of $8,042,941 with working capital of $1,472,414.
To accomplish our business plans, we will be required to continue to conduct substantial development activities for ENMD-2076, our leading program. Under our operating plans for 2010, we expect to continue to pursue ENMD-2076 in oncology and complete enrollment of patients in our ovarian cancer Phase 2 trial at six sites in the United States and Canada. We expect our 2010 results of operations to reflect a net loss of approximately $8,200,000, including non-cash charges of approximately $4,400,000.
We expect that the majority of our 2010 revenues will continue to be from royalties on the sales of Thalomid®. Thalomid® is sold by a third-party and we have no control over such party’s sales efforts or the resources devoted to Thalomid® sales, or the impact that generic drugs or alternative products will have on the sales of Thalomid®. We expect to record royalty-sharing revenues in the fourth quarter of 2010; however, there can be no assurance of the amount of revenues that will be recorded, if any. In addition, under our licensing agreement with Oxford Biomedica, PLC and Oxford Biomedica (UK) Limited Oxford, we are entitled to receive payments upon the achievement of certain milestones with respect to the development of gene therapies for ophthalmic (eye) diseases. However, we do not control the drug development efforts of Oxford and have no control over when or whether such milestones will be reached. We do not believe that we will receive any developmental milestone payments under this agreement in 2010.
INFLATION AND INTEREST RATE CHANGES
Management does not believe that our working capital needs are sensitive to inflation and changes in interest rates.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The primary objective of our investment activities is to preserve our capital until it is required to fund operations while at the same time maximizing the income we receive from our investments without incurring investment market volatility risk. Our investment income is sensitive to the general level of U.S. interest rates. In this regard, changes in the U.S. interest rates affect the interest earned on our cash and cash equivalents. Due to the short-term nature of our cash and cash equivalent holdings, a 10% movement in market interest rates would not materially impact on the total fair market value of our portfolio as of June 30, 2010.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Based on an evaluation under the supervision and with the participation of the Company’s management, the Company’s Executive Chairman and Principal Accounting Officer have concluded that the Company’s disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) were effective as of June 30, 2010 to ensure that information required to be disclosed by the Company in reports that it files or submits under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission rules and forms and (ii) accumulated and communicated to the Company’s management, including its Executive Chairman and Principal Accounting Officer, as appropriate to allow timely decisions regarding required disclosure.
Management’s assessment of the effectiveness of internal control over financial reporting is expressed at the level of reasonable assurance because a control system, no matter how well designed and operated, can provide only reasonable, but not absolute, assurance that the control system’s objectives will be met.
Changes in Internal Control Over Financial Reporting
There were no changes in the Company’s internal control over financial reporting that occurred during the quarter ended June 30, 2010 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
We are subject in the normal course of business to various legal proceedings in which claims for monetary or other damages may be asserted. We are not currently a party to any legal proceedings.
ITEM 1A. RISK FACTORS
For information regarding factors that could affect the Company’s results of operations, financial condition and liquidity, see the risk factors discussion set forth in Item 1A of EntreMed’s Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and the information under “Special Note Regarding Forward-Looking Statements” included in this report. There have been no material changes to our risk factors from those disclosed in Item 1A in our Annual Report on Form 10-K for the fiscal year ended December 31, 2009.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Not applicable.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable.
ITEM 4. RESERVED
ITEM 5. OTHER INFORMATION
Not applicable.
ITEM 6. EXHIBITS
| 31.1 | Rule 13a-14(a) Certification of Executive Chairman |
| 31.2 | Rule 13a-14(a) Certification of Principal Accounting Officer |
| 32.1 | Section 1350 Certification of Executive Chairman |
| 32.2 | Section 1350 Certification of Principal Accounting Officer |
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.
| | ENTREMED, INC. | |
| | (Registrant) | |
| | | |
| Date: August 16, 2010 | /s/ Michael M. Tarnow | |
| | Michael M. Tarnow | |
| | Executive Chairman | |
| | | |
| Date: August 16, 2010 | /s/ Kathy R. Wehmeir-Davis | |
| | Kathy R. Wehmeir-Davis | |
| | Principal Accounting Officer | |
EXHIBIT INDEX
| 31.1 | Rule 13a-14(a) Certification of Executive Chairman |
| 31.2 | Rule 13a-14(a) Certification of Principal Accounting Officer |
| 32.1 | Section 1350 Certification of Executive Chairman |
| 32.2 | Section 1350 Certification of Principal Accounting Officer |
