EOM Pharmaceutical Holdings, Inc. - Quarter Report: 2011 March (Form 10-Q)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2011
¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission file number 033-17264-NY
ImmunoCellular Therapeutics, Ltd.
(Exact name of registrant as specified in its charter)
DELAWARE | 93-1301885 | |
(State or other jurisdiction of incorporation or organization) |
(IRS Employer Identification No.) |
21900 Burbank Boulevard, 3rd Floor
Woodland Hills, California 91367
(Address of principal executive offices)
(818) 992-2907
(Registrants 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.
Large accelerated filer | ¨ | Accelerated Filer | ¨ | |||
Non-accelerated filer | ¨ | Smaller reporting company | x |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
The Issuer had 28,958,506 shares of its common stock outstanding as of May 11, 2011.
Table of Contents
ImmunoCellular Therapeutics, Ltd.
FORM 10-Q
Table of Contents
Page | ||||||||
PART I FINANCIAL INFORMATION | 1 | |||||||
Item 1. | Financial Statements | 1 | ||||||
Condensed Balance Sheets as of December 31, 2010 and March 31, 2011 (unaudited) |
1 | |||||||
2 | ||||||||
3 | ||||||||
4 | ||||||||
5 | ||||||||
Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations. | 21 | ||||||
Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 25 | ||||||
Item 4. | Controls and Procedures | 25 | ||||||
PART II OTHER INFORMATION | 26 | |||||||
Item 1. | Legal Proceedings | 26 | ||||||
Item 1A. | Risk Factors | 26 | ||||||
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 26 | ||||||
Item 3. | Defaults Upon Senior Securities | 26 | ||||||
Item 4. | Removed and Reserved | 26 | ||||||
Item 6. | Exhibits | 28 | ||||||
SIGNATURES | 29 | |||||||
EXHIBIT LIST | 30 |
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FINANCIAL INFORMATION
Item 1. | Financial Statements |
ImmunoCellular Therapeutics, Ltd.
(A Development Stage Company)
Condensed Balance Sheets
December 31, 2010 |
March 31, 2011 |
|||||||
(unaudited) | ||||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and short-term investments |
$ | 5,319,776 | $ | 11,254,225 | ||||
Other assets |
24,033 | 60,304 | ||||||
Total current assets |
5,343,809 | 11,314,529 | ||||||
Fixed assets, net |
12,367 | 46,689 | ||||||
Other assets |
8,974 | 8,974 | ||||||
Total assets |
$ | 5,365,150 | $ | 11,370,192 | ||||
Liability and Shareholders Equity |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 171,065 | $ | 50,612 | ||||
Accrued liabilities |
276,384 | 363,832 | ||||||
Total current liabilities |
447,449 | 414,444 | ||||||
Warrant liability |
2,581,871 | 6,105,642 | ||||||
Commitments and contingencies |
| | ||||||
Shareholders equity: |
||||||||
Common stock, $0.0001 par value; 74,000,000 shares authorized; 22,213,602 shares and 28,151,469 shares issued and outstanding as of December 31, 2010 and March 31, 2011, respectively |
2,221 | 2,815 | ||||||
Additional paid in capital |
25,341,679 | 30,613,984 | ||||||
Promissory note |
(54,282 | ) | (54,634 | ) | ||||
Deficit accumulated during the development stage |
(22,953,788 | ) | (25,712,059 | ) | ||||
Total shareholders equity |
2,335,830 | 4,850,106 | ||||||
Total liabilities and shareholders equity |
$ | 5,365,150 | $ | 11,370,192 | ||||
The accompanying notes are an integral part of these unaudited condensed financial statements.
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ImmunoCellular Therapeutics, Ltd.
(A Development Stage Company)
Condensed Statements of Operations
(unaudited)
For the
Three Months Ended March 30, 2010 |
For the
Three Months Ended March 31, 2011 |
February
25, 2004 (Inception) to March 31, 2011 |
||||||||||
Revenues |
$ | | $ | | $ | 300,000 | ||||||
Expenses: |
||||||||||||
Research and development |
179,695 | 917,214 | 6,477,481 | |||||||||
Merger costs |
| | 73,977 | |||||||||
Stock based compensation |
131,083 | 241,981 | 7,271,853 | |||||||||
General and administrative |
451,197 | 553,721 | 7,098,443 | |||||||||
Total expenses |
761,975 | 1,712,916 | 20,921,754 | |||||||||
Loss before other income and income taxes |
(761,975 | ) | (1,712,916 | ) | (20,621,754 | ) | ||||||
Interest income |
473 | 1,636 | 336,424 | |||||||||
Increase in fair value of warrant liability |
(6,960 | ) | (1,046,991 | ) | (3,334,229 | ) | ||||||
Loss before income taxes |
(768,462 | ) | (2,758,271 | ) | (23,619,559 | ) | ||||||
Income taxes |
| | | |||||||||
Deemed dividend on preferred stock |
| | (2,092,500 | ) | ||||||||
Net loss |
$ | (768,462 | ) | $ | (2,758,271 | ) | $ | (25,712,059 | ) | |||
Weighted average number of shares: |
||||||||||||
Basic and diluted |
14,965,595 | 24,314,228 | 11,748,134 | |||||||||
Loss per share: |
||||||||||||
Basic and diluted |
$ | (0.05 | ) | $ | (0.11 | ) | $ | (2.19 | ) | |||
The accompanying notes are an integral part of these unaudited condensed financial statements.
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ImmunoCellular Therapeutics, Ltd.
(A Development Stage Company)
Condensed Statements of Shareholders Equity
(unaudited)
Preferred Stock | Common Stock | Additional Paid-In Capital |
Promissory Note |
Deficit Accumulated During the Development Stage |
Total | |||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||
Initial capitalization at $0.00002 per share |
| $ | | 6,256,500 | $ | 10 | $ | 87 | $ | | $ | | $ | 97 | ||||||||||||||||||
Common stock issued for cash during 2004 at $0.00078 per share |
| | 193,500 | 15 | 135 | | | 150 | ||||||||||||||||||||||||
Net loss |
| | | | | | (11,741 | ) | (11,741 | ) | ||||||||||||||||||||||
Balance at December 31, 2004 |
| | 6,450,000 | 25 | 222 | | (11,741 | ) | (11,494 | ) | ||||||||||||||||||||||
Common stock issued for cash during 2005 at $0.19 per share |
| | 387,000 | 659 | 74,341 | | | 75,000 | ||||||||||||||||||||||||
Common stock issued for cash during 2005 at $0.32 per share |
| | 154,800 | 16 | 49,984 | | | 50,000 | ||||||||||||||||||||||||
Common stock issued for research and development during 2005 at $0.99 per share |
| | 154,800 | 15 | 152,745 | | | 152,760 | ||||||||||||||||||||||||
Net loss |
| | | | | | (246,004 | ) | (246,004 | ) | ||||||||||||||||||||||
Balance at December 31, 2005 |
| | 7,146,600 | 715 | 277,292 | | (257,745 | ) | 20,262 | |||||||||||||||||||||||
Common stock issued for services during 2006 at $0.50 per share |
| | 73,093 | 7 | 36,539 | | | 36,546 | ||||||||||||||||||||||||
Common stock issued for cash during 2006 in private placements at $1.00 per share, net of redemptions |
| | 1,510,000 | 151 | 549,249 | | | 549,400 | ||||||||||||||||||||||||
Common stock issued for research and development during 2006 at $1.00 per share |
| | 694,000 | 69 | 693,931 | | | 694,000 | ||||||||||||||||||||||||
Shares issued in connection with reverse merger |
| | 825,124 | 83 | (83 | ) | | | | |||||||||||||||||||||||
Shares cancelled in connection with the sale of Optical Molecular Imaging, Inc. |
| | (2,059,100 | ) | (206 | ) | (64,794 | ) | | | (65,000 | ) | ||||||||||||||||||||
Exercise of stock options |
| | 10,062 | 1 | 3,521 | | | 3,522 | ||||||||||||||||||||||||
Stock based compensation (options) |
| | | | 4,103,645 | | | 4,103,645 | ||||||||||||||||||||||||
Net loss |
| | | | | | (5,152,713 | ) | (5,152,713 | ) | ||||||||||||||||||||||
Balance at December 31, 2006 |
| | 8,199,779 | 820 | 5,599,300 | | (5,410,458 | ) | 189,662 | |||||||||||||||||||||||
Common stock issued for cash during 2007 in private placements at $1.50 per share |
| | 3,531,603 | 353 | 4,892,133 | | | 4,892,486 | ||||||||||||||||||||||||
Exercise of stock options |
| | 51,111 | 5 | (5 | ) | | | | |||||||||||||||||||||||
Reclassification of warrant derivative liability |
| | | | 2,233,600 | | | 2,233,600 | ||||||||||||||||||||||||
Stock based compensation (options) |
| | | | 1,296,714 | | | 1,296,714 | ||||||||||||||||||||||||
Net loss |
| | | | | | (3,614,753 | ) | (3,614,753 | ) | ||||||||||||||||||||||
Balance at December 31, 2007 |
| | 11,782,493 | 1,178 | 14,021,742 | | (9,025,211 | ) | 4,997,709 | |||||||||||||||||||||||
Common stock issued for research and development during 2008 at $0.53 per share |
| | 800,000 | 80 | 423,920 | | | 424,000 | ||||||||||||||||||||||||
Common stock issued for research and development during 2008 at $0.65 per share |
| | 100,000 | 10 | 64,990 | | | 65,000 | ||||||||||||||||||||||||
Stock based compensation (options) |
| | | | 513,357 | | | 513,357 | ||||||||||||||||||||||||
Net loss |
| | | | | | (3,059,730 | ) | (3,059,730 | ) | ||||||||||||||||||||||
Balance at December 31, 2008 |
| | 12,682,493 | 1,268 | 15,024,009 | | (12,084,941 | ) | 2,940,336 | |||||||||||||||||||||||
Exercise of warrants |
| | 1,970,992 | 1,97 | 462,551 | | | 462,748 | ||||||||||||||||||||||||
Exercise of stock options |
| | 214,357 | 22 | 64,460 | (52,668 | ) | | 11,814 | |||||||||||||||||||||||
Stock based compensation (options) |
| | | | 308,302 | | | 308,302 | ||||||||||||||||||||||||
Net loss |
| | | | | | (2,626,205 | ) | (2,626,205 | ) | ||||||||||||||||||||||
Balance at December 31, 2009 |
| | 14,867,842 | 1,487 | 15,859,322 | (52,668 | ) | (14,711,146 | ) | 1,096,995 | ||||||||||||||||||||||
Common stock and warrants issued for cash during 2010 at $1.00 per share, net of offering costs |
| | 4,230,910 | 423 | 3,248,315 | | | 3,248,738 | ||||||||||||||||||||||||
Preferred stock and warrants issued for cash during 2010 at $10,000 per share, net of offering costs |
400 | | | | | | | | ||||||||||||||||||||||||
Exercise of warrants in exchange for promissory note |
| | 2,700,000 | 270 | 5,399,730 | (5,400,000 | ) | | | |||||||||||||||||||||||
Redemption of preferred stock for repayment of promissory note |
(400 | ) | | | | | 5,400,000 | (2,092,500 | ) | 3,307,500 | ||||||||||||||||||||||
Exercise of stock options |
| | 50,000 | 5 | 26,495 | | | 26,500 | ||||||||||||||||||||||||
Cashless exercise of stock options |
| | 297,156 | 30 | (30 | ) | | | | |||||||||||||||||||||||
Common stock issued for services during 2010 at $0.90 per share |
| | 60,000 | 6 | 53,994 | | | 54,000 | ||||||||||||||||||||||||
Common stock issued for services during 2010 at $1.06 per share |
| | 7,694 | | 8,156 | | | 8,156 | ||||||||||||||||||||||||
Stock based compensation |
| | | | 745,697 | | | 745,697 | ||||||||||||||||||||||||
Interest on promissory note |
| | | | | (1,614 | ) | | (1,614 | ) | ||||||||||||||||||||||
Net loss |
| | | | | | (6,150,142 | ) | (6,150,142 | ) | ||||||||||||||||||||||
Balance at December 31, 2010 |
| | 22,213,602 | 2,221 | 25,341,679 | (54,282 | ) | (22,953,788 | ) | 2,335,830 | ||||||||||||||||||||||
Common stock and warrants issued for cash during 2011 at $1.55 per share, net of offering costs |
| | 5,219,768 | 522 | 4,982,816 | | | 4,983,338 | ||||||||||||||||||||||||
Exercise of stock options |
| | 66,000 | 7 | 47,573 | | | 47,580 | ||||||||||||||||||||||||
Cashless exercise of stock options |
| | 652,099 | 65 | (65 | ) | | | | |||||||||||||||||||||||
Stock based compensation |
| | | | 241,981 | | | 241,981 | ||||||||||||||||||||||||
Interest on promissory note |
| | | | | (352 | ) | | (352 | ) | ||||||||||||||||||||||
Net loss |
| | | | | | (2,758,271 | ) | (2,758,271 | ) | ||||||||||||||||||||||
Balance at March 31, 2011 |
| | 28,151,469 | $ | 2,815 | $ | 30,613,984 | $ | (54,634 | ) | $ | (25,712,059 | ) | $ | 4,850,106 | |||||||||||||||||
The accompanying notes are an integral part of these condensed financial statements.
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ImmunoCellular Therapeutics, Ltd.
(A Development Stage Company)
Condensed Statements of Cash Flows
(unaudited)
For the Three Months Ended March 31, 2010 |
For the Three Months Ended March 31, 2011 |
February 25, 2004 (Inception) to March 31, 2011 |
||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (768,462 | ) | $ | (2,758,271 | ) | $ | (23,619,559 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
Depreciation and amortization |
908 | 3,603 | 12,708 | |||||||||
Interest earned on promissory note |
| (352 | ) | (1,616 | ) | |||||||
Increase in fair value of warrant liability |
6,960 | 1,046,991 | 3,334,229 | |||||||||
Stock-based compensation |
131,083 | 241,981 | 7,209,348 | |||||||||
Common stock issued for services |
| | 98,703 | |||||||||
Common stock issued for research and development |
| | 1,335,760 | |||||||||
Changes in assets and liabilities: |
||||||||||||
Other assets |
(30,744 | ) | (36,271 | ) | (99,559 | ) | ||||||
Accounts payable |
(32,155 | ) | (120,453 | ) | 50,612 | |||||||
Accrued liabilities |
15,349 | 87,449 | 363,832 | |||||||||
Net cash used in operating activities |
(677,061 | ) | (1,535,323 | ) | (11,315,542 | ) | ||||||
Cash flows from investing activities: |
||||||||||||
Purchase of property and equipment |
| (37,925 | ) | (99,397 | ) | |||||||
Cash paid for sale of Optical Molecular Imaging, Inc. |
| | (25,000 | ) | ||||||||
Net cash used in investing activities |
| (37,925 | ) | (124,397 | ) | |||||||
Cash flows from financing activities: |
||||||||||||
Exercise of stock options |
| 47,578 | 89,412 | |||||||||
Exercise of warrants |
| | 462,748 | |||||||||
Proceeds from issuance of common stock and warrants under private placements, net of offering costs |
1,684,968 | 7,460,119 | 18,237,599 | |||||||||
Proceeds from issuance of preferred stock under private placements, net of offering costs |
| | 3,779,158 | |||||||||
Proceeds from issuance of common stock |
| | 125,247 | |||||||||
Net cash provided by financing activities |
1,684,968 | 7,507,697 | 22,694,164 | |||||||||
Increase (decrease) in cash and short-term investments |
1,007,907 | 5,934,449 | 11,254,225 | |||||||||
Cash and short-term investments at beginning of period |
1,407,256 | 5,319,776 | | |||||||||
Cash and short-term investments at end of period |
$ | 2,415,163 | $ | 11,254,225 | $ | 11,254,225 | ||||||
Supplemental cash flows disclosures: |
||||||||||||
Interest expense paid |
$ | | $ | | $ | | ||||||
Income taxes paid |
$ | | $ | | $ | | ||||||
The accompanying notes are an integral part of these unaudited condensed financial statements.
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ImmunoCellular Therapeutics, Ltd.
(A Development Stage Company)
Notes to Unaudited Condensed Financial Statements
1. | Nature of Organization and Development Stage Operations |
ImmunoCellular Therapeutics, Ltd. (the Company) is a development stage company that is seeking to develop and commercialize new therapeutics to fight cancer using the immune system.
Since the Companys inception on February 25, 2004, the Company has been primarily engaged in the acquisition of certain intellectual property, together with development of its product candidates and the recent clinical testing activities for one of its vaccine product candidates, and has not generated any recurring revenues. As a result, the Company has incurred operating losses and, as of March 31, 2011, the Company had an accumulated deficit of $25,712,059. The Company expects to incur significant research, development and administrative expenses before any of its products can be launched and recurring revenues generated.
Interim Results
The accompanying condensed financial statements at March 31, 2011 and for the three months period ended March 31, 2010 and 2011 are unaudited, but include all adjustments, consisting of normal recurring entries, which the Companys management believes to be necessary for a fair presentation of the periods presented. Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 2010 have been derived from our audited financial statements as of that date.
The financial statements included herein have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (SEC). Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the U.S. have been condensed or omitted pursuant to such rules and regulations. Certain prior year amounts have been reclassified to conform to the 2010 financial statement presentation. The financial statements should be read in conjunction with the Companys audited financial statements in its Form 10-K for the year ended December 31, 2010. The Companys operating results will fluctuate for the foreseeable future. Therefore, period-to-period comparisons should not be relied upon as predictive of the results in future periods.
2. | Summary of Significant Accounting Policies |
Development Stage Enterprise The Company is a development stage enterprise as defined by Financial Accounting Standard Boards Topic 915, Accounting and Reporting by Development Stage Enterprises. The Company is devoting substantially all our present efforts to research and development. All losses accumulated since inception are considered part of the Companys development stage activities.
Liquidity - As of March 31, 2011, the Company had working capital of $10,900,085, compared to working capital of $4,896,360 as of December 31, 2010. The estimated cost of completing the development of either of our current vaccine product candidates and of obtaining all required regulatory approvals to market either of those product candidates is substantially greater than the amount of funds the Company currently has available. However, the Company believes that its existing cash balances will be sufficient to fund its currently planned level of operations for at least the next twelve months, although there is no assurance that such proceeds will be sufficient for this purpose.
Cash and Short-Term Investments The Company considers all highly liquid debt instruments with an original maturity of 90 days or less to be cash equivalents. As of December 31, 2010 and March 31, 2011, the Company had $4,500,000 and $4,035,677 respectively, of certificates of deposit. These securities were fully
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covered by FDIC insurance and mature within the next six months. They are classified as held-to-maturity and under ASC Topic 320, Investments Debt and Equity Securities, are measured at cost since the Company has the intent and ability to hold these securities to maturity.
Property and Equipment - Property and equipment are stated at cost and depreciated using the straight-line methods based on the estimated useful lives (generally three to five years) of the related assets. Computer and computer equipment are depreciated over 3 years. Management continuously monitors and evaluates the realizability of recorded long-lived assets to determine whether their carrying values have been impaired. The Company records impairment losses on long-lived assets used in operations when events and circumstances indicate that the assets might be impaired and the nondiscounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. Any impairment loss is measured by comparing the fair value of the asset to its carrying amount. Repairs and maintenance costs are expensed as incurred.
Research and Development Costs - Research and development expenses consist of costs incurred for direct research and development and are expensed as incurred.
Stock Based Compensation Financial Accounting Standards Board (FASB) ASC Topic 718, Compensation Stock Based requires that the cost resulting for all share-based payment transactions be recognized in the Companys condensed financial statements.
Fair value was estimated at the date of grant using the Black-Scholes pricing model, with the following weighted average assumptions:
Three Months Ended March 31, 2010 | ||
Risk-free interest rate |
1.38% | |
Expected dividend yield |
None | |
Expected life |
3.78 years | |
Expected volatility |
118.0% |
The weighted-average grant-date fair value of options granted during the three months ended March 31, 2010 was $0.61. There were no options granted during the three months ended March 31, 2011.
The risk-free interest rate used in the Black-Scholes valuation method is based on the implied yield currently available in U.S. Treasury securities at maturity with an equivalent term. The Company has not declared or paid any dividends and does not currently expect to do so in the future. The expected term of options represents the period that our stock-based awards are expected to be outstanding and was determined based on projected holding periods for the remaining unexercised shares. Consideration was given to the contractual terms of our stock-based awards, vesting schedules and expectations of future employee behavior. Expected volatility is based on market prices of traded options for comparable entities within our industry.
The Companys stock price volatility and option lives involve managements best estimates, both of which impact the fair value of the option calculated under the Black-Scholes methodology and, ultimately, the expense that will be recognized over the life of the option.
When options are exercised, our policy is to issue previously unissued shares of common stock to satisfy share option exercises. As of March 31, 2011, the Company had approximately 45.8 million shares of authorized but unissued common stock.
No tax benefits were attributed to the stock-based compensation expense because a valuation allowance was maintained for substantially all net deferred tax assets.
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Income Taxes The Company accounts for federal and state income taxes in accordance with ASC Topic 740, Income Taxes. Under the liability method, a deferred tax asset or liability is determined based on the difference between the financial statement and tax basis of assets and liabilities, as measured by the enacted tax rates. The Companys provision for income taxes represents the amount of taxes currently payable, if any, plus the change in the amount of net deferred tax assets or liabilities. A valuation allowance is provided against net deferred tax assets if recoverability is uncertain on a more likely than not basis. ASC 740 clarifies the accounting for uncertainty in income tax positions (tax positions). The provisions of ASC 740 require the Company to recognize in its financial statements the impact of a tax position if the position will more likely than not be sustained upon examination by a taxing authority, based on the technical merits of the position. In the initial year of adoption, ASC 740 provided that the cumulative effect of this change in accounting principle, if any, be recorded as an adjustment to opening retained earnings. The Company adopted the provisions of ASC 740 effective January 1, 2007. The adoption of the provisions of ASC 740 had no effect on the Companys financial statements. The Companys policy is to recognize interest related to unrecognized tax benefits as interest expense and penalties as operating expenses. The Company is not currently under examination by any taxing authority nor has it been notified of an impending examination.
The Company recognizes interest and penalties for uncertain tax positions in income tax expense. Upon adoption and as of March 31, 2011, the Company had no interest and penalty accrual or expense.
Fair Value of Financial Instruments - The carrying amounts reported in the condensed balance sheets for cash, cash equivalents, short-term investments and accounts payable approximate their fair values due to their quick turnover.
Use of Estimates - The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make certain estimates and assumptions about the future outcome of current transactions which may affect the reporting and disclosure of these transactions. Accordingly, actual results could differ from those estimates used in the preparation of these financial statements.
Basic and Diluted Loss per Common Share Basic and diluted loss per common share are computed based on the weighted average number of common shares outstanding. Common share equivalents (which consist of options and warrants) are excluded from the computation of diluted loss per share since the effect would be antidilutive. Common share equivalents which could potentially dilute basic earnings per share in the future, and which were excluded from the computation of diluted loss per share, totaled 39,014,677 shares and 40,977,430 shares at March 31, 2010 and 2011, respectively.
Recently Issued Accounting Standards In June 2009, the FASB, issued the FASB Accounting Standards Codification. All existing accounting standard documents were superceded by the Codification and the Codification became the source of all authoritative generally accepted accounting principles, or GAAP, except for rules and interpretive releases from the SEC, which are still sources of authoritative GAAP for SEC registrants. All guidance contained in the Codification carries an equal level of authority. All other non-grandfathered, non-SEC accounting literature not included in the Codification has become nonauthoritative. The Codification is effective for interim or annual periods ending after September 15, 2009, and the Company is using the new guidelines and numbering systems prescribed by the Codification when referring to GAAP in these condensed financial statements for the period ended March 31, 2011. As the Codification was not intended to change or alter existing GAAP, it did not have any impact on the Companys financial position or results of operations.
On January 1, 2009, the Company adopted ASC Topic 805, Business Combinations, to require that assets and liabilities assumed in a business combination that arise from contingencies be recognized at fair value if fair value can be reasonably estimated. The adoption of this provision did not have a material impact on the Companys financial statements.
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3. | Property and Equipment |
As of December 31, 2010 and March 31, 2011, $21,472 and $59,397 of equipment had been placed into service. Depreciation expense was $908 and $3,603 for the three months ended March 31, 2010 and March 31, 2011, respectively. Depreciation expense was $12,708 for the period from February 25, 2004 (date of inception) to March 31, 2011.
4. | Related-Party Transactions |
Cedars-Sinai Medical Center License Agreement
In November 2006, the Company entered into a license agreement with Cedars-Sinai Medical Center (Cedars-Sinai) under which the Company acquired an exclusive, worldwide license to its technology for use as cellular therapies, including cancer stem cell and dendritic cell-based vaccines for neurological disorders that include brain tumors and neurodegenerative disorders and other cancers. This technology is covered by a number of pending U.S. and foreign patent applications, and the term of the license will be until the last to expire of any patents that are issued covering this technology.
As an upfront licensing fee, the Company issued Cedars-Sinai 694,000 shares of its common stock and paid Cedars-Sinai $62,000. Additional specified milestone payments will be required to be paid to Cedars-Sinai when the Company initiates patient enrollment in its first Phase III clinical trial and when it receives FDA marketing approval for its first product.
The Company has agreed to pay Cedars-Sinai specified percentages of all of its sublicensing income and gross revenues from sales of products based on the licensed technology, subject to a reduction if it must make any payments to any third party whose proprietary rights would be infringed by sale of the products. To maintain its rights to the licensed technology, the Company must meet certain development and funding milestones. These milestones include, among others, commencing a Phase I clinical trial for a product candidate by March 31, 2007 and raising at least $5,000,000 in funding from equity or other sources by December 31, 2008. The Company satisfied the foregoing funding requirement in 2007 and commenced a Phase I clinical trial in May 2007, which was within the applicable cure period for the milestone requirement. Through March 31, 2011, the Company has paid Cedars-Sinai a total of $250,369 in connection with the Phase I clinical trial. The Company also was required to commence a Phase II clinical trial for a product candidate by December 31, 2008 and a waiver of this requirement was obtained from Cedars-Sinai (see Second Amendment below).
On June 16, 2008, the Company entered into a First Amendment to Exclusive License Agreement (the Amendment) with Cedars-Sinai. The Amendment amended the License Agreement to include in the Companys exclusive license from Cedars-Sinai under that agreement an epitope to CD133 and certain related intellectual property. Management believes this technology will be covered by a U.S. patent application that will be filed by the parties. Pursuant to the Amendment, the Company issued Cedars-Sinai 100,000 shares of the Companys common stock as an additional license fee for the licensed CD133 epitope technology, which will be subject to the royalty and other terms of the License Agreement.
On July 22, 2009, the Company entered into a Second Amendment to Exclusive License Agreement (the Second Amendment) with Cedars-Sinai to become effective August 1, 2009. The Second Amendment amended the License Agreement to revise the milestones set forth in the License Agreement that the Company must achieve in order to maintain its license rights under that agreement. The revised milestones include the replacement of a milestone that required commencement of a Phase II clinical trial for the Companys first product candidate by no later than December 31, 2008 with milestones that require commencement of a Phase I clinical trial for the Companys second product candidate by no later than June 30, 2010 and commencement of a Phase II clinical trial for one of the Companys product candidates by no later than March 31, 2012.
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Effective March 23, 2010, the Company entered into a Third Amendment to Exclusive License Agreement (the Third Amendment) with Cedars-Sinai. The Third Amendment amended the License Agreement to revise the milestones set forth in the License Agreement that the Company must achieve in order to maintain its license rights under that agreement. The revised milestones include the replacement of a milestone that required commencement of a Phase I clinical trial for the Companys second product candidate by no later than June 30, 2010 and commencement of a Phase II clinical trial for one of the Companys product candidates by no later than March 31, 2012 with a requirement that the Company by September 30, 2011 either commence a Phase II clinical trial for its dendritic cell vaccine candidate or a Phase I clinical trial for its cancer stem cell vaccine candidate. The amendment also added a requirement that the Company obtain certain defined forms of equity or other funding in the amount of at least $2,500,000 by December 31, 2010 and a total of at least $5,000,000 by September 30, 2011. These Phase II clinical trial and funding requirements have been fully satisfied.
5. | Commitments and Contingencies: |
Employment Agreement with Dr. Manish Singh
On March 4, 2010, the Company entered into an Employment Agreement, effective as of February 18, 2010, with Dr. Manish Singh pursuant to which Dr. Singh will continue to serve on a full-time basis as the Companys President and Chief Executive Officer for a one-year term commencing February 18, 2010. The Company is required under the Employment Agreement to use its commercially reasonable efforts to have Dr. Singh continue to serve as a member of the Companys Board of Directors during the term of the Employment Agreement. The Employment Agreement may be extended for an additional one-year period upon the mutual agreement of the Company and Dr. Singh. Dr. Singh continued to serve as the Companys President and Chief Executive Officer under the terms of this Employment Agreement after its one-year term until he entered into a new Employment Agreement with the Company in May 2011 that was made effective as of February 18, 2011 (see Footnote 8).
The Employment Agreement provides for an annual base salary of $300,000. In addition, provided that Dr. Singh continues to serve as the Companys President and Chief Executive Officer for the entire one-year term of the Employment Agreement, the Company will pay Dr. Singh a discretionary cash bonus of up to $50,000 upon completion of the one-year term.
The Employment Agreement dated as of February 18, 2009 between the Company and Dr. Singh (the Prior Agreement) provides that Dr. Singh is entitled to receive cash milestone bonuses, not to exceed an aggregate amount of $200,000, of (1) $50,000 upon the Companys completion of a financing, a strategic alliance or a merger or acquisition generating at least $2,500,000 of net proceeds (after commissions) during the term of the Prior Agreement, (2) $100,000 upon the Companys completion of a financing, a strategic alliance or a merger or acquisition generating at least $5,000,000 of net proceeds (after commissions) during the term of the Prior Agreement, or (3) $200,000 upon the Companys completion of a financing, a strategic alliance or a merger or acquisition generating at least $10,000,000 of net proceeds (after commissions) during the term of the Prior Agreement. The Prior Agreement also provides that an option granted to Dr. Singh to purchase 200,000 shares of the Companys common stock will vest if the Companys working capital is at least $8,000,000 at the end of the term of the Prior Agreement.
The Employment Agreement amends the Prior Agreement to provide that the milestones described in the preceding paragraph may be satisfied by including the net proceeds received by the Company at any time prior to August 17, 2010 from (1) a financing by the Socius Capital Group or (2) any private placement financing that is covered by a signed term sheet that was entered into by the Company prior to February 18, 2010 or from another source at the same or better terms as contemplated by such signed term sheet. Also, for purposes of determining whether the $8,000,000 working capital milestone in the preceding paragraph has been satisfied, the Employment Agreement provides that working capital will be calculated as of the date of the Companys receipt of the proceeds that are being included to satisfy the milestone.
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Pursuant to the Employment Agreement, the Company granted to Dr. Singh a 7-year incentive stock option under the Companys 2006 Equity Incentive Plan (the Plan), or a new qualified option plan, to purchase 600,000 shares of the Companys common stock at an exercise price equal to $0.90 per share, which was the closing market price of the common stock on the option grant date. The option grant is subject to the approval by the Companys stockholders of an increase in the authorized number of shares under the Plan and an increase in the number of shares that may be granted to any individual during a 12-month period. The option may be exercised during the period that Dr. Singh provides services to the Company and for 24 months after termination for any reason except termination for cause by the Company, provided that such exercise is within the 7-year term of the option.
The option granted to Dr. Singh under the Employment Agreement will vest (1) as to 360,000 shares, in 12 equal monthly installments of 30,000 shares each over the 12-month period from and immediately following the grant date, (2) as to 30,000 shares, if the Company achieves during the term of the Employment Agreement a volume-weighted average trading price for its common stock of greater than $1.60 for any consecutive 15-day trading period during the term of the agreement on average daily trading volume of at least 20,000 shares, (3) as to 90,000 shares, if the Company achieves during the term of the Employment Agreement a volume-weighted average trading price for its common stock of greater than $2.00 for any consecutive 15-day trading period during the term of the agreement on average daily trading volume of at least 20,000 shares, (4) as to 30,000 shares, upon treating the first patient in a Phase II clinical trial, and (5) as to 90,000 shares, if during the term of the Employment Agreement the Company completes a financing, a strategic alliance or a licensing agreement with upfront licensing payments to the Company or a merger or acquisition that generates at least $5,000,000 of net proceeds (after commissions) for the Company beyond the $10,000,000 achieved by August 17, 2010, with any financing proceeds received by the Company during the first 6 months of the Employment Agreement that are used to satisfy milestones under the Prior Agreement not being included as proceeds to satisfy the milestones described in this paragraph.
In the event that the Company terminates the Employment Agreement without cause or does not extend the Employment Agreement upon its expiration for an additional one-year term, then (1) the Company upon such termination will be required to make a lump sum payment to Dr. Singh equal to 6 months of his base annual salary, (2) any stock options granted to Dr. Singh, to the extent vested, will be retained by Dr. Singh and will be exercisable on the terms described above, and (3) the vesting of an additional number of shares subject to all options granted to Dr. Singh equal to 50% of all shares subject to such options that have not already vested will immediately accelerate and will be exercisable on the terms described above. If Dr. Singh terminates his employment for good reason as defined in the Employment Agreement, he will receive the severance benefits described in the preceding sentence, except that 100% of his options will vest if his employment terminates for good reason following a merger or similar corporate transaction in which the Company is not the surviving entity.
Employment Agreement with Dr. James Bender
On March 4, 2010, the Company entered into an Employment Agreement, effective as of February 1, 2010, with Dr. James Bender pursuant to which Dr. Bender will serve on a full-time basis as the Companys Vice President Product Development and Manufacturing for a one-year term commencing February 1, 2010. Prior to February 1, 2010, Dr. Bender had been serving on a part-time basis as the Companys Vice President Clinical Development pursuant to an Agreement dated as of September 1, 2009, as amended on September 14, 2009 (the Prior Agreement). Dr. Bender continued to serve as the Companys Vice President-Product Development and Manufacturing under the terms of this Employment Agreement after its one-year term until he entered into a new Employment Agreement with the Company in May 2011 that was made effective as of February 1, 2011 (see Footnote 8).
The Employment Agreement provides for an annual base salary of $170,000. Pursuant to the Employment Agreement, the Company granted to Dr. Bender a 7-year incentive stock option under the Companys Plan to purchase 150,000 shares of the Companys common stock at an exercise price equal to $0.90 per share, which was the closing market price of the common stock on the option grant date. The option grant is subject to the approval by the Companys stockholders of an increase in the authorized number of shares under the Plan.
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The option granted to Dr. Bender under the Employment Agreement will vest at the rate of 6,250 shares per month over the term of the Employment Agreement as to 75,000 shares. The option will vest as to the remaining 75,000 shares upon the Companys attainment of the following development milestones, and Dr. Bender will also be entitled to receive the following cash bonuses upon attainment of these milestones: (1) completion by September 30, 2010 of the technology transfer to a contract manufacturer for the Companys ICT-107 product will result in a $10,000 cash bonus and the vesting of 25,000 option shares; (2) completion by December 31, 2010 of FDA acceptance of a Phase II clinical trial plan for ICT-107 will result in a $10,000 cash bonus and the vesting of 25,000 option shares; and (3) completion by December 31, 2010 of the enrollment of the first patient into the Phase II clinical trial for ICT-107 will result in a $10,000 bonus and the vesting of 25,000 option shares.
The Employment Agreement provides that all of the rights and obligations of the Company and Dr. Bender under the Prior Agreement (including Dr. Benders right to work for another organization) terminated as of January 31, 2010, except that Dr. Benders right under the Prior Agreement to receive cash bonuses and the vesting of options upon the Companys achievement of specified development milestones will remain in effect.
The Employment Agreement provides that, except as described in the following sentence, if Dr. Benders employment terminates prior to the expiration of the one-year term, Dr. Bender will not have any right to receive further compensation under the Employment Agreement other than compensation that was accrued as of his employment termination date. If the Company terminates Dr. Benders employment without cause as defined in the Employment Agreement, 50% of any unvested options held by Dr. Bender as of the employment termination date will vest, and he will also have the right to receive any compensation that was accrued as of the employment termination date.
Agreement with Dr. John Yu
Effective March 1, 2010, the Company entered into an Agreement with Dr. Yu under which he agreed to serve on a part-time basis as the Companys Chief Scientific Officer for a one-year term. Dr. Yu continued to serve as the Companys Chief Scientific Officer under this Agreement after its one-year term until he entered into a new Agreement with the Company in May 2011 that was made effective as of March 1, 2011 (see Footnote 8).
The Companys Agreement with Dr. Yu provides for an annual base salary of $70,000 and for cash bonuses of $15,000 each if prior to December 31, 2010 (i) the FDA has accepted a Phase II clinical trial plan for ICT-107 and (ii) a Physicians Investigator IND submission for one of the Companys specified product candidates has been accepted by the FDA.
Pursuant to the Agreement, the Company granted to Dr. Yu a seven-year nonqualified stock option under the Companys 2006 Equity Incentive Plan to purchase 125,000 shares of the Companys common stock at an exercise price equal to $0.90 per share, which was the closing market price of the common stock on the option grant date. The option grant is subject to the approval by the Companys stockholders of an increase in the authorized number of shares under the Plan. The option may be exercised during the period that Dr. Yu provides services to the Company and for 24 months after termination for any reason except termination for cause by the Company, provided that such exercise is within the seven-year term of the option.
The option granted to Dr. Yu under the Agreement will vest (i) as to 75,000 shares in four equal quarterly installments following the date of grant and (ii) as to the remaining 50,000 shares, 25,000 shares shall each vest upon timely satisfying the two milestones described above for the payment of cash bonuses to Dr. Yu.
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Research and Development
In connection with the Cedars-Sinai Medical Center License Agreement, the Company has certain commitments as described in Note 4.
6. | Shareholders Equity |
Common Stock
In March 2010, the Company raised $1,654,686 (after commissions and offering expenses) from the sale of 1,740,000 shares of common stock and warrants to purchase 696,000 shares of common stock at an exercise price of $1.15 per share, to various investors in a private placement. (See Warrants and Warrant Liabilities below.)
In May 2010, the Company raised $2,716,308 (after commissions and offering expenses) from the sale of 2,490,910 shares of common stock and warrants to purchase 1,245,455 shares of common stock at an exercise price of $1.50 per share, to various investors in a private placement. (See Warrants and Warrant Liabilities below)
In February 2011, the Company raised $7,460,119 (after commissions and offering expenses) from the sale of 5,219,768 shares of common stock and warrants to purchase 2,609,884 shares of common stock at an exercise price of $2.25 per share, to various investors in a private placement. (See Warrants and Warrant Liabilities below)
Preferred Stock
On December 3, 2009, the Company entered into a Preferred Stock Purchase Agreement dated as of December 3, 2009 (the Preferred Stock Agreement) with Socius Capital Group, LLC, a Delaware limited liability company d/b/a Socius Life Sciences Capital Group, LLC (the Investor). Pursuant to the Preferred Stock Agreement, the Company will issue to the Investor up to $10,000,000 of the Companys newly created Series A Preferred Stock (the Preferred Stock). The purchase price of the Preferred Stock is $10,000 per share. The shares of Preferred Stock that are issued to the Investor will bear a cumulative dividend of 10.0% per annum, payable in shares of Preferred Stock, will be redeemable under certain circumstances and will not be convertible into shares of the Companys common stock. Subject to the terms and conditions of the Preferred Stock Agreement, the Company has the right to determine (1) the number of shares of Preferred Stock that it will require the Investor to purchase from the Company, up to a maximum purchase price of $10,000,000, (2) whether it will require the Investor to purchase Preferred Stock in one or more traunches, and (3) the timing of such required purchase or purchases of Preferred Stock.
The terms of the Preferred Stock are set forth in a Certificate of Designations of Preferences, Rights and Limitations of Series A Preferred Stock that the Company filed with the Delaware Secretary of State on December 3, 2009.
Pursuant to the Preferred Stock Agreement, the Company agreed to pay the Investor a commitment fee of $500,000 (the Commitment Fee), with $250,000 payable when the Company makes its first election to require the Investor to purchase shares of Preferred Stock and with the remaining $250,000 payable when the aggregate amount of Preferred Stock purchased by the Investor equals at least $5,000,000; provided, however, that the first $250,000 portion of the Commitment Fee will be due and payable on the six-month anniversary of
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the effective date of the registration statement described below even if no sales of Preferred Stock to the Investor have occurred by that date. The Company has the right to elect to pay each installment of the Commitment Fee in immediately available funds or by issuance of shares of common stock. In January 2010, the Company accrued $250,000 in commitment fees associated with the Preferred Stock Agreement.
Concurrently with its execution of the Preferred Stock Agreement, the Company issued to the Investor a warrant (the Warrant) to purchase shares of common stock with an aggregate exercise price of up to $13,500,000 depending upon the amount of Preferred Stock that is purchased by the Investor. Each time that the Company requires the Investor to purchase shares of Preferred Stock, a portion of the Warrant will become exercisable by the Investor over a five-year period for a number of shares of common stock equal to (1) the aggregate purchase price payable by the Investor for such shares of Preferred Stock multiplied by 135%, with such amount divided by (2) the per share Warrant exercise price. The initial exercise price under the Warrant is $1.04 per share of common stock. Thereafter, the exercise price for each portion of the Warrant that becomes exercisable upon the Companys election to require the Investor to purchase Preferred Stock will equal the closing price of the common stock on the date that the Company delivers its election notice. The Investor is entitled to pay the Warrant exercise price in immediately available funds, by delivery of a secured promissory note or, if a registration statement covering the resale of the common stock subject to the Warrant is not in effect, on a cashless basis.
Pursuant to the Preferred Stock Agreement, the Company agreed to file with the Securities and Exchange Commission a registration statement covering the resale of the shares of common stock that are issuable to the Investor under the Warrant and in satisfaction of the Commitment Fee. The registration statement was deemed effective on January 22, 2010. The 1.2 million shares of common stock registered for the Commitment Fee are held in escrow by the Company.
On May 2, 2010, the Company issued and sold 400 shares of the Preferred Stock to Socius Capital Group, LLC pursuant to the terms of the Preferred Stock Agreement. The aggregate purchase price for the Preferred Stock was $4,000,000 (less $220,842 in Commitment Fees and offering expenses). Under the terms of the Preferred Stock Agreement, Socius remains obligated, from time to time until December 3, 2012, to purchase up to an additional 600 shares of Preferred Stock at a purchase price of $10,000 per share upon notice from the Company to Socius, and subject to the satisfaction of certain conditions, as set forth in the Preferred Stock Agreement.
In connection with the foregoing transaction, a portion of the warrants held by an affiliate of Socius became vested and exercisable covering 2,700,000 shares of the Companys common stock for a five-year period at an exercise price of $2.00 per share under the terms of the Preferred Stock Agreement. In consideration of Socius agreeing to grant the Company certain waivers under the Preferred Stock Agreement, this affiliate also became entitled to purchase up to an additional 1,350,000 shares of the Companys common stock at an exercise price of $2.50 per share. On May 2, 2010, the affiliate of Socius exercised a portion of its warrant for 1,675,000 shares and paid the $3,350,000 exercise price for these shares by delivering a four-year full recourse promissory note for this amount, as permitted by the Preferred Stock Agreement. The Company immediately thereafter redeemed approximately 248 shares of the Preferred Stock by offsetting the $3,350,000 redemption price for these shares against the $3,350,000 owed to the Company under the note. On December 2, 2010, the affiliate of Socius exercised the remaining portion of its warrant for 1,025,000 shares and paid the $2,050,000 exercise price for these shares by delivering a four-year full recourse promissory note for this amount, as permitted by the Preferred Stock Agreement. The Company immediately thereafter redeemed approximately 152 shares of the Preferred Stock by offsetting the $2,050,000 redemption price for these shares against the $2,050,000 owed to the Company under the note. (See Warrants and Warrant Liabilities below.)
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Stock Options
In February 2005, the Company adopted an Equity Incentive Plan (Plan). Pursuant to the Plan, a committee appointed by the Board of Directors may grant, at its discretion, qualified or nonqualified stock options, stock appreciation rights and may grant or sell restricted stock to key individuals, including employees, nonemployee directors, consultants and advisors. Option prices for qualified incentive stock options (which may only be granted to employees) issued under the plan may not be less than 100% of the fair market value of the common stock on the date the option is granted (unless the option is granted to a person who, at the time of grant, owns more than 10% of the total combined voting power of all classes of stock of the Company; in which case the option price may not be less than 110% of the fair market value of the common stock on the date the option is granted). Option prices for nonqualified stock options issued under the Plan are at the discretion of the committee and may be equal to, greater or less than fair market value of the common stock on the date the option is granted. The options vest over periods determined by the Board of Directors and are exercisable no later than ten years from date of grant (unless they are qualified incentive stock options granted to a person owning more than 10% of the total combined voting power of all classes of stock of the Company, in which case the options are exercisable no later than five years from date of grant). As of March 31, 2011, the Company has reserved 6,000,000 shares of common stock for issuance under the Plan and options to purchase 2,812,154 common shares have been granted under the Plan that are currently outstanding.
The following is a summary of stock option grants issued outside the Plan:
In January 2007, the Company granted an option to purchase 1,500,000 shares of its common stock at an exercise price of $1.10 per share to the Chairman of the Companys Scientific Advisory Board.
In November 2006, the Company granted an option to purchase 300,000 shares of its common stock at an exercise price of $1.00 per share to an affiliate of the Companys then Chairman of the Board.
In November 2006, the Company granted an option to purchase 5,933,424 shares of its common stock at an exercise price of $1.00 per share to a Board member in connection with the Cedars-Sinai license acquisition.
The following table summarizes stock option activity for the Company during the three months ended March 31, 2011:
Options | Weighted Average Exercise Price |
Weighted Average Remaining Contractual Term |
Aggregate Intrinsic Value |
|||||||||||||
Outstanding December 31, 2010 |
11,094,845 | $ | 0.94 | |||||||||||||
Granted |
| $ | | |||||||||||||
Exercised |
(926,267 | ) | $ | 0.48 | ||||||||||||
Forfeited or expired |
(5,000 | ) | $ | 0.95 | ||||||||||||
Outstanding March 31, 2011 |
10,163,578 | $ | 0.98 | 5.39 | $ | 13,427,949 | ||||||||||
Vested or expected to vest at March 31, 2011 |
9,802,453 | $ | 0.98 | 5.45 | $ | 12,935,114 | ||||||||||
As of March 31, 2011, the total unrecognized compensation cost related to unvested stock options amounted to $110,643, which will be amortized over the weighted-average remaining requisite service period of less than one year.
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Warrants
In connection with the March 2010 common stock private placement, the Company issued to the investors warrants to purchase 696,000 shares of the Companys common stock at $1.15 per share. The warrants have a term of 26 months from the date of issuance. As of March 31, 2011, warrants to purchase 696,000 shares of the Companys common stock were outstanding related to this private placement. (See Warrant Liabilities below.)
In connection with the May 2010 common stock private placement, the Company issued to the investors warrants to purchase 1,245,455 shares of the Companys common stock at $1.50 per share. The warrants have a term of 36 months from the date of issuance. As of March 31, 2011, warrants to purchase 1,245,455 shares of the Companys common stock were outstanding related to this private placement. (See Warrant Liabilities below.)
In connection with the May 2010 Preferred Stock sale, the Company issued warrants to purchase 2,700,000 shares of common stock at an exercise price of $2.00 held by an affiliate of Socius. The warrants have a term of five-year from the date of issuance. In consideration of Socius agreeing to grant the Company certain waivers under the Preferred Stock Purchase Agreement, this affiliate also became entitled to purchase up to an additional 1,350,000 shares of the Companys common stock at an exercise price of $2.50 per share. In May 2010, the affiliate of Socius exercised a portion of its warrant for 1,675,000 shares and paid the $3,350,000 exercise price for these shares by delivering a four-year full recourse promissory note for this amount, as permitted by the Preferred Stock Purchase Agreement. The Company immediately thereafter redeemed approximately 248 shares of the Preferred Stock by offsetting the $3,350,000 redemption price for these shares against the $3,350,000 owed to the Company under the note. In December 2010, the affiliate of Socius exercised the remaining portion of its warrant for 1,025,000 shares and paid the $2,050,000 exercise price for these shares by delivering a four-year full recourse promissory note for this amount, as permitted by the Preferred Stock Purchase Agreement. The Company immediately thereafter redeemed approximately 152 shares of the Preferred Stock by offsetting the $2,050,000 redemption price for these shares against the $2,050,000 owed to the Company under the note. As of March 31, 2011, no warrants to purchase of the Companys common stock at $2.00 were outstanding and warrants to purchase 1,350,000 shares of the Companys common stock at $2.50 were outstanding related to this private placement. (See Warrant Liabilities below.)
In connection with an investor relations agreement in December 2010, the Company issued a two-year warrant to purchase 50,000 shares of the Companys common stock at an exercise price of $1.60.
In connection with the February 2011 common stock private placement, the Company issued to the investors warrants to purchase 2,609,884 shares of the Companys common stock at $2.25 per share. The warrants have a five-year term from the date of issuance. As of March 31, 2011, warrants to purchase 2,609,884 shares of the Companys common stock were outstanding related to this private placement. (See Warrant Liabilities below.)
Warrant Liability
In connection with the March 2010 common stock private placement, the Company issued to the investors warrants to purchase 696,000 shares of the Companys common stock at $1.15 per share. Of the total proceeds from the March 2010 common stock private placement, $257,520 was allocated to the freestanding warrants associated with the units based upon the fair value of the warrants determined under the Black Scholes option pricing model. The warrants contain a provision whereby the warrant exercise price would be decreased in the event that certain future common stock issuances are made at a price less than $1.00.
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Under ASC 815 Derivatives and Hedging, the March 2010 warrants do not qualify for equity treatment due to the potential variability of their exercise price, and therefore are recognized as a liability. The warrant liability will be adjusted to fair value each reporting period, and any changes in value will be recognized in the statement of operations. The warrants contain a provision whereby the warrant exercise price would be decreased in the event that certain future common stock issuances are made at a price less than $1.00. For periods prior to the three months ended March 31, 2011, the Company previously had concluded that the value of the conversion feature does not materially differ from the valuation of such warrants using the Monte Carlo or lattice simulation models, and therefore, the use of the Black-Scholes valuation model was considered a reasonable method to value the warrants. The assumptions used in the Black Scholes model for determining the initial fair value of the warrants were as follows: (i) dividend yield of 0%; (ii) expected volatility of 102%, (iii) risk-free interest rate of 1.00%, and (iv) contractual life of 26 months. For the three months ended March 31, 2010, the Company recorded a charge to other income for the change in fair value of warrant liability of $6,960. During the three months ended March 31, 2011, the Company determined that it was more appropriate to value the warrants using a binomial lattice simulation model. The lattice simulation model used by the Company at March 31, 2011, assumed (i) dividend yield of 0%; (ii) expected volatility of 84%; (iii) risk free rate of 0.34% and (iv) expected term of 1.17 years. Based upon this model, the Company recorded a credit to other income of $80,040 during the three months ended March 31, 2011.
In connection with the May 2010 common stock private placement, the Company issued to the investors warrants to purchase 1,245,455 shares of the Companys common stock at $1.50 per share. Of the total proceeds from the May 2010 common stock private placement, $834,455 was allocated to the freestanding warrants associated with the units based upon the fair value of the warrants determined under the Black Scholes option pricing model. The warrants contain a provision whereby the warrant exercise price would be decreased in the event that certain future common stock issuances are made at a price less than $1.00.
Under ASC 815 Derivatives and Hedging, the May 2010 warrants do not qualify for equity treatment due to the potential variability of their exercise price, and therefore are recognized as a liability. The warrant liability will be adjusted to fair value each reporting period, and any changes in value will be recognized in the statement of operations. The warrants contain a provision whereby the warrant exercise price would be decreased in the event that certain future common stock issuances are made at a price less than $1.00. For periods prior to the three months ended March 31, 2011, the Company previously had concluded that the value of the conversion feature does not materially differ from the valuation of such warrants using the Monte Carlo or binomial lattice simulation models, and therefore, the use of the Black-Scholes valuation model was considered a reasonable method to value the warrants. The assumptions used in the Black Scholes model for determining the initial fair value of the warrants were as follows: (i) dividend yield of 0%; (ii) expected volatility of 102%, (iii) risk-free interest rate of 1.375%, and (iv) contractual life of 36 months. During the three months ended March 31, 2011, the Company determined that it was more appropriate to value the warrants using a binomial lattice simulation model. The lattice simulation model used by the Company at March 31, 2011, assumed (i) dividend yield of 0%; (ii) expected volatility of 127%; (iii) risk free rate of 0.67% and (iv) expected term of 2.17 years. Based upon this model, the Company recorded a charge to other income of $184,328 during the three months ended March 31, 2011.
In connection with the May 2010 Preferred Stock sale, the Company vested warrants to purchase 2,700,000 shares of common stock at an exercise price of $2.00 held by an affiliate of Socius and issued warrants to purchase an additional 1,350,000 shares of the Companys common stock at an exercise price of $2.50 per share. Of the total proceeds from the May 2010 preferred stock sale, $5,710,500 was allocated to the freestanding warrants associated with the units based upon the fair value of these warrants determined under the Black Scholes option pricing model. The excess of the value of the freestanding warrants over the net proceeds of $1,931,342 was charged to change in fair value of warrant liability in the statement of operations. The warrants contain a provision whereby the warrant may be settled for cash in connection with a change of control with a private company. In May 2010, the affiliate of Socius exercised a portion of its warrant for 1,675,000 shares, which reduced warrant liabilities by $2,395,250. In December 2010, the affiliate of Socius exercised a portion of its warrant for 1,025,000 shares, which reduced warrant liabilities by $912,250.
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Under ASC 815 Derivatives and Hedging, the May 2010 Preferred Stock warrants do not qualify for equity treatment, and are recognized as a liability. The warrant liability will be adjusted to fair value each reporting period, and any changes in value will be recognized in the statement of operations. The warrants contain a provision whereby the warrant may be settled for cash in connection with a change of control with a private company. For periods prior to the three months ended March 31, 2011, the Company previously used the Black Scholes valuation model to value the warrants. The assumptions used in the Black Scholes model for determining the initial fair value of the warrants were as follows: (i) dividend yield of 0%; (ii) expected volatility of 102%, (iii) risk-free interest rate of 2.50%, and (iv) contractual life of 60 months. During the three months ended March 31, 2011, the Company determined that it was more appropriate to value the warrants using a binomial lattice simulation model. The lattice simulation model used by the Company at March 31, 2011, assumed (i) dividend yield of 0%; (ii) expected volatility of 138%; (iii) risk free rate of 1.60% and (iv) expected term of 4.17 years. Based upon this model, the Company recorded a charge to other income of $214,650 during the three months ended March 31, 2011.
In connection with the February 2011 common stock private placement, the Company issued to the investors warrants to purchase 2,609,884 shares of the Companys common stock at $2.25 per share. Of the total proceeds from the February 2011 common stock private placement, $2,476,780 was allocated to the freestanding warrants associated with the units based upon the fair value of the warrants determined under the Binomial lattice model. The warrants contain a provision whereby the warrant exercise price would be decreased in the event that certain future common stock issuances are made at a price less than $1.55.
Under ASC 815 Derivatives and Hedging, the February 2011 warrants do not qualify for equity treatment due to the potential variability of their exercise price, and therefore are recognized as a liability. The warrant liability will be adjusted to fair value each reporting period, and any changes in value will be recognized in the statement of operations. The warrants contain a provision whereby the warrant exercise price would be decreased in the event that certain future common stock issuances are made at a price less than $2.25. The Company valued these warrants using a binomial lattice simulation model assuming (i) dividend yield of 0%; (ii) expected volatility of 146%; (iii) risk free rate of 1.96% and (iv) expected term of 5 years. Based upon those calculations, the Company calculated the initial valuation of the warrants to be $2,476,780. As of March 31, 2011, the Company revalued the warrants using the lattice simulation model assuming (i) dividend yield of 0%; (ii) expected volatility of 146%; (iii) risk free rate of 1.96% and (iv) expected term of 4.9 years and has recorded a charge to other income for the change in the fair value of the warrant liability of $728,054.
The following is a reconciliation of the beginning and ending balances for warrant liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) during the period ended March 31, 2011:
Warrant Liabilities |
||||
Balance December 31, 2010 |
$ | 2,581,871 | ||
Issuance of warrants |
2,476,780 | |||
Exercise of warrants |
| |||
(Gain) or Loss included in earnings |
1,046,991 | |||
Transfers in and/or out of Level 3 |
| |||
Balance March 31, 2011 |
$ | 6,105,642 | ||
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Promissory Note
In October 2009, the Companys former President exercised stock options for 150,479 shares of common stock and as provided under the stock option agreement provided the Company with a full recourse five-year promissory note bearing interest of 2.59% per annum. The promissory note is secured by a pledge of shares being acquired with all proceeds of any sale to be applied first to retire in full the promissory note. The Company recorded the promissory note as an offset against shareholders equity.
7. | Comprehensive Loss |
For the three months ended March 31, 2011 and 2010, there was no other comprehensive loss and accordingly a Statement of Other Comprehensive Loss has not been presented. Comprehensive income would normally include: foreign currency translation adjustments, a change in the market value of a futures contract that qualifies as a hedge of an asset reported at fair value, a net loss recognized as an additional pension liability not yet recognized as net periodic pension cost, and unrealized holding gains and losses on available-for-sale securities.
8. | Subsequent Events |
Employment Agreement with Manish Singh
On May 10, 2011, the Company entered into an Employment Agreement, effective as of February 18, 2011, with Dr. Manish Singh pursuant to which Dr. Singh will continue to serve on a full-time basis as the Companys President and Chief Executive Officer for a one-year term commencing February 18, 2011. The Company is required under the Employment Agreement to use its commercially reasonable efforts to have Dr. Singh continue to serve as a member of the Companys Board of Directors during the term of the Employment Agreement. The Employment Agreement automatically renews on the one-year anniversary date of the effective date of February 18, 2011 of each year thereafter for successive one-year terms unless terminated by either party.
The Employment Agreement provides for an annual base salary of $315,000. In addition, provided that Dr. Singh continues to serve as the Companys President and Chief Executive Officer for the entire one-year term of the Employment Agreement, the Company will pay Dr. Singh a discretionary cash bonus of up to $100,000 upon the attainment of certain corporate goals.
The Employment Agreement also provides Dr. Singh a seven-year incentive stock option grant to purchase 270,000 shares of common stock under the Companys 2006 Equity Incentive Plan (the Plan) at an exercise price of $2.25 per share, which was the closing price of the Companys common stock on the date of grant. The option will vest as follows; (i) 20,000 shares on February 17, 2012, (ii) 50,000 shares on February 17, 2013, (iii) 50,000 shares on February 17, 2014, (iv) 50,000 shares upon the Company attaining a market capitalization of at least $100 million for ten consecutive trading dates, (v) 50,000 shares upon the Company attaining a market capitalization of at least $150 million for ten consecutive trading days and (vi) 50,000 shares upon the Company attaining a market capitalization of at least $200 million for ten consecutive trading days. The option may be exercised during the term that Dr. Singh provides services to the Company and for twelve months after termination for any reason except termination for cause by the Company, provided that such exercise is within the seven-year term of the option.
In the event that the Company terminates the Employment Agreement without cause, then (i) the Company upon such termination will be required to make a lump sum payment to Dr. Singh equal to six months of his base annual salary, (ii) any stock options granted to Dr. Singh, to the extent vested, will be retained by Dr. Singh and will be exercisable on the terms described above, and (3) the vesting of an additional number of shares subject to all options granted to Dr. Singh equal to 50% of all shares subject to such options that vest based solely on the passage of time and that have not already vested will immediately accelerate and
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will be exercisable on the terms described above. If Dr. Singh terminates his employment for good reason as defined in the Employment Agreement, he will receive the severance benefits described in the preceding sentence, except that 100% of his options will vest if his employment terminates for good reason following a merger or similar corporate transaction in which the Company is not the surviving entity and the surviving entity does not offer Dr. Singh an executive position at a compensation level at least equal to his then compensation under the Employment Agreement.
Employment Agreement with James Bender
On May 10, 2011, the Company entered into an Employment Agreement, effective as of February 1, 2011, with Dr. James Bender pursuant to which Dr. Bender will continue to serve on a full-time basis as the Companys Vice President Product Development and Manufacturing for a one-year term commencing February 1, 2011. The Employment Agreement automatically renews on the one-year anniversary date of the effective date of February 1, 2011 of each year thereafter for successive one-year terms unless terminated by either party.
The Employment Agreement provides for an annual base salary of $175,000. In addition, provided that Dr. Bender continues to serve as the Companys Vice President Product Development and Manufacturing for the entire one-year term of the Employment Agreement, the Company will pay Dr. Bender a discretionary cash bonus of up to $35,000 upon the attainment of certain corporate goals.
The Employment Agreement also provides Dr. Bender a seven-year incentive stock option grant to purchase 120,000 shares of common stock under the Plan at an exercise price of $2.25 per share, which was the closing price of the Companys common stock on the date of grant. The option will vest as to (i) 60,000 shares in three annual installments of 20,000 shares each, with the first installment to vest on January 31, 2012; (ii) 20,000 shares upon the Company attaining a market capitalization of at least $100 million for ten consecutive trading dates; (iii) 20,000 shares upon the Company attaining a market capitalization of at least $150 million for ten consecutive trading dates; and (iv) 20,000 shares upon the Company attaining a market capitalization of at least $200 million for ten consecutive trading dates. The option may be exercised during the term that Dr. Bender provides services to the Company and for twelve months after termination for any reason except termination for cause by the Company, provided that such exercise is within the seven-year term of the option.
In the event that the Company terminates the Employment Agreement without cause, then (i) the Company upon such termination will be required to make a lump sum payment to Dr. Bender equal to six months of his base annual salary, (ii) any stock options granted to Dr. Bender, to the extent vested, will be retained by Dr. Bender and will be exercisable on the terms described above, and (iii) the vesting of an additional number of shares subject to all options granted to Dr. Bender equal to 50% of all shares subject to such options that vest solely on the passage of time and that have not already vested will immediately accelerate and will be exercisable on the terms described above. If Dr. Bender terminates his employment for good reason as defined in the Employment Agreement, he will receive the severance benefits described in the preceding sentence, except that 100% of his options will vest if his employment terminates for good reason following a merger or similar corporate transaction in which the Company is not the surviving entity and the surviving entity does not offer Dr. Bender an executive position at a compensation level at least equal to his then compensation under the Employment Agreement.
Agreement with John Yu
On May 10, 2011, the Company entered into an Agreement, effective as of March 1, 2011, with Dr. John Yu pursuant to which Dr. Yu will continue to serve as the Companys Chief Scientific Officer for a one-year term commencing March 1, 2011. The term of this Agreement will automatically renew on the one-year anniversary date of the Agreement each year after March 1, 2011 for successive one-year terms unless either party terminates. Dr. Yu may also terminate the Agreement at any time upon 60 days notice.
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The Agreement provides for an annual base salary of $70,000. In addition, Dr. Yu will receive a bonus of $15,000 each (a maximum total of $30,000) upon and provided that the Company achieves each of the following milestones within one year from the March 1, 2011: (i) enrollment of 75 patients in the Phase II trial of ICT-107 and (ii) filing of an IND for either a new indication for ICT-107 or for another product candidate of the Company.
The Agreement also provides Dr. Yu a seven-year incentive stock option grant to purchase 50,000 shares of common stock under the Plan at an exercise price of $1.95 per share, which was the closing price of the Companys common stock on the date of grant. The option will vest in three equal annual installments, with the first vesting date to be February 29, 2012. The option may be exercised during the term that Dr. Yu provides services to the Company and for twelve months after termination for any reason except termination without cause by Dr. Yu or termination for cause by the Company, provided that such exercise is within the seven-year term of the option. All of the options granted to Dr. Yu will vest if his services terminate following a merger or similar corporate transaction in which the Company is not the surviving entity and the surviving entity does not offer Dr. Yu an executive position at a compensation level at least equal to his then compensation level under the Agreement.
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Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations. |
Throughout this Quarterly Report on Form 10-Q, the terms we, us, our, and our company refer to ImmunoCellular Therapeutics, Ltd., a Delaware corporation formerly known as Optical Molecular Imaging, Inc.
Cautionary Statement Regarding Forward-Looking Statements
This Quarterly Report contains forward-looking statements, which reflect the views of our management with respect to future events and financial performance. These forward-looking statements are subject to a number of uncertainties and other factors that could cause actual results to differ materially from such statements. Forward-looking statements are identified by words such as anticipates, believes, estimates, expects, plans, projects, targets and similar expressions. Readers are cautioned not to place undue reliance on these forward-looking statements, which are based on the information available to management at this time and which speak only as of this date. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For a discussion of some of the factors that may cause actual results to differ materially from those suggested by the forward-looking statements, please read carefully the information in the Risk Factors section in our Form 10-K for the year ended December 31, 2010. The identification in this Quarterly Report of factors that may affect future performance and the accuracy of forward-looking statements is meant to be illustrative and by no means exhaustive. All forward-looking statements should be evaluated with the understanding of their inherent uncertainty.
Overview
On January 31, 2006, we completed a merger pursuant to which Spectral Molecular Imaging, Inc. became our wholly owned subsidiary. At the time of the merger, we had virtually no assets or liabilities, and we had not conducted any business operations for several years. In connection with the merger, we changed our name from Patco Industries, Ltd. to Optical Molecular Imaging, Inc. and replaced our officers and directors with those of Spectral Molecular Imaging. Although we acquired Spectral Molecular Imaging in the merger, for accounting purposes the merger was treated as a reverse merger since the stockholders of Spectral Molecular Imaging acquired a majority of our outstanding shares of common stock and the directors and executive officers of Spectral Molecular Imaging became our directors and executive officers. Accordingly, our financial statements contained in this Annual Report and the description of our results of operations and financial condition reflect the operations of Spectral Molecular Imaging.
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In May 2006, we decided to suspend our research and development activities on Spectral Molecular Imagings spectral imaging technology, and on September 11, 2006, we sold all of the outstanding capital stock of Spectral Molecular Imaging to Dr. Daniel Farkas, a co-founder of Spectral Molecular Imaging and inventor of its technology.
In November 2006, we acquired an exclusive, worldwide license from Cedars-Sinai Medical Center for certain cellular-based therapy technology that we are developing for the potential treatment of brain tumors and other forms of cancer and neurodegenerative disorders. We recently completed a Phase I clinical trial of a vaccine product candidate for the treatment of glioblastoma multiforme based on this technology.
In February 2008, we acquired certain monoclonal antibody related technology owned by Molecular Discoveries LLC. This technology consists of (1) a platform technology referred to by Molecular Discoveries as DIAAD for the potentially rapid discovery of targets (antigens) and monoclonal antibodies for diagnosis and treatment of diverse human diseases and (2) certain monoclonal antibody candidates for the potential detection and treatment of multiple myeloma, small cell lung, pancreatic and ovarian cancers.
Plan of Operation
We are a development stage company that is seeking to develop and commercialize new therapeutics to fight cancer using the immune system.
Since our companys inception on February 25, 2004, we have been primarily engaged in the acquisition of certain intellectual property, together with the recent clinical testing activities for one of our vaccine product candidates, and have not generated any recurring revenues. As a result, we have incurred operating losses and, as of March 31, 2011, we had an accumulated deficit of $25,712,059. We expect to incur significant research, development and administrative expenses before any of our products can be launched and recurring revenues, if ever, are generated.
Critical Accounting Policies
Managements discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates, including those related to impairment of long-lived assets, including finite lived intangible assets, accrued liabilities and certain expenses. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.
Our significant accounting policies are summarized in Note 2 of our financial statements for the period from February 25, 2004 to March 31, 2011. We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our financial statements:
Development Stage Enterprise
We are a development stage enterprise as defined by FASB ASC Topic 915, Development Stage Enterprises. We are devoting substantially all of our present efforts to research and development. All losses accumulated since inception are considered as part of our development stage activities.
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Research and Development Costs
Although we believe that our research and development activities and underlying technologies have continuing value, the amount of future benefits to be derived from them is uncertain. Research and development costs are therefore expensed as incurred rather than capitalized. During the three months ended March 31, 2010 and 2011, we recorded an expense of $179,695 and $917,214, respectively, related to research and development activities.
Stock-Based Compensation
FASB ASC Topic 718, Compensation-Stock Based require that the cost resulting from all share-based payment transactions be recognized in our condensed financial statements.
We adopted the fair value recognition provisions of ASC Topic 718 utilizing the modified-prospective-transition method. Under this transition method, compensation cost recognized during the twelve months ended December 31, 2006 includes: (a) compensation cost for all share-based payments granted prior to, but not yet vested as of January 1, 2006, based on the grant date fair value estimated, and (b) compensation expense for all share-based payments granted subsequent to January 1, 2006, based on the grant-date fair value estimated. Under the modified-prospective-transition method, results for the prior periods have not been restated.
Results of Operations
Revenues
We had no revenues during the three months ended March 31, 2010 and 2011. We do not expect to generate any operating revenues during 2011.
Expenses
General and administrative expenses for the three months ended March 31, 2010 and 2011 were $451,197 and $553,721, respectively. The increase in general and administrative expenses is primarily due to increases in personnel costs, investor relations and professional fees. Included in personnel costs are bonuses tied to the achievement of certain clinical milestones.
Research and development expenses for the three months ended March 31, 2010 and 2011 were $179,695 and $917,214, respectively. The increase in research and development expenses is primarily due to increased costs associated with the commencement of Phase II clinical trials of ICT-107.
We had $138,951 of non-cash expense for the three months ended March 31, 2010, consisting of $131,083 of stock based compensation, $6,960 of change in fair value of the warrant derivatives and $908 of depreciation expense. For the three months ended March 31, 2011, we incurred $1,292,575 of non-cash expense consisting of $241,981 of stock based compensation, $1,046,991 of change in fair value of warrant derivatives, and $3,603 of depreciation expense.
Loss
We incurred a net loss of $768,462 and $2,758,271 for the three months ended March 31, 2010 and 2011, respectively.
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Liquidity and Capital Resources
As of March 31, 2011, we had working capital of $10,900,085, compared to working capital of $4,896,360 as of December 31, 2010.
We do not currently anticipate that we will derive any revenues from either product sales or licensing during the foreseeable future. We do not have any bank credit lines and have financed all of our prior operations through the sale of securities, including private placements in March 2010, May 2010 and February 2011 that generated proceeds for us (before commissions and offering expenses) of $1,740,000, $6,740,001 and $8,090,644 respectively.
The estimated cost of completing the development of either of our current vaccine product candidates and of obtaining all required regulatory approvals to market either of those product candidates is substantially greater than the amount of funds we currently have available. We believe that our existing cash balances will be sufficient to fund our currently planned level of operations for at least the next twelve months. We will seek to obtain additional funds through various financing sources, including possible sales of our securities, and in the longer term through strategic alliances with other pharmaceutical or biopharmaceutical companies.
In December 2009, we entered into an agreement with Socius Capital under which Socius Capital has agreed to purchase from us from time to time an aggregate of up to $10 million of our preferred stock and we sold them $4 million of these shares in May 2010. However, Socius Capitals obligation to purchase the remaining $6 million of shares of our preferred stock is subject to our satisfying certain conditions at that time. There is no assurance that we will be able to satisfy those conditions if we wish to sell shares of our preferred stock to Socius Capital or that Socius Capital will have ability to complete these purchases. If we are unsuccessful or only partly successful in our efforts to secure additional funding, we may find it necessary to suspend or terminate some or all of our product development and other activities.
As of March 31, 2011, we had no long-term debt obligations, no capital lease obligations, no material purchase obligations or other similar long-term liabilities. In addition, we have no financial guarantees, debt or lease agreements or other arrangements that could trigger a requirement for an early payment or that could change the value of our assets, and we do not engage in trading activities involving non-exchange traded contracts.
Cash Flows
We used $677,061 of cash in our operations for the three months ended March 31, 2010, compared to $1,535,323 for the three months ended March 31, 2011. During the three months ended March 31, 2011, we greatly expanded our research and development activities and incurred additional personnel related costs. During the three months ended March 31, 2011, we also incurred greater non-cash expenses consisting primarily of a valuation adjustment to our warrant liabilities of $1,046,991 compared to $6,960 in the same period last year.
We used no cash from our investing activities for the three months ended March 31, 2010. During the three months ended March 31, 2011, we purchased $37,925 of machinery to support our research and development activities.
During the three months ended March 31, 2010, we received net proceeds $1,684,968 from the issuance of common stock and warrants and during the three months ended March 31, 2011, we received net proceeds of $7,460,119 from the issuance of common stock and warrants. Additionally, during the three months ended March 31, 2011, we received $47,578 from the exercise of stock options.
Inflation and changing prices have had no effect on our net sales and revenues or on our income from continuing operations over our two most recent fiscal years.
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Item 3. | Quantitative and Qualitative Disclosures About Market Risk |
Not Applicable.
Item 4. | Controls and Procedures |
As of the end of the fiscal quarter covered by this report, we carried out an evaluation, under the supervision and with the participation of our principal executive officer and principal financial officer, regarding the effectiveness of the design and operation of our disclosure controls and procedures pursuant to SEC Rule 15d-15(b) of the Exchange Act. Based upon that evaluation, our principal executive officer and principal financial officer concluded that, as of March 31, 2011, (i) our disclosure controls and procedures were effective to ensure that information that is required to be disclosed by us in reports that we file under the Exchange Act is recorded, processed, summarized and reported or submitted within the time period specified in the rules and forms of the SEC and (ii) our disclosure controls and procedures were effective to provide reasonable assurance that material information required to be disclosed by us in the reports we file or submit under the Exchange Act was accumulated and communicated to our management as appropriate to allow timely decisions regarding required disclosure. There were no changes in our internal control over financial reporting that occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
We do not expect that our disclosure controls and procedures and internal control over financial reporting will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our company have been detected. The design of any system of controls also is based in part upon assurance that any design will succeed in achieving its stated goals under all potential future conditions. However, controls may become inadequate because of changes in conditions or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
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OTHER INFORMATION
Item 1. | Legal Proceedings |
None.
Item 1A. | Risk Factors |
N/A
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
The Company did not issue any unregistered securities during the three -month period ended March 31, 2011 that were not previously reported in a Current Report on Form 8-K, and the Company did not repurchase any securities during that period.
Item 3. | Defaults Upon Senior Securities |
None.
Item 4. | Removed and Reserved |
Item 5. | Other Information |
Employment Agreement with Manish Singh
On May 10, 2011, the Company entered into an Employment Agreement, effective as of February 18, 2011, with Dr. Manish Singh pursuant to which Dr. Singh will continue to serve on a full-time basis as the Companys President and Chief Executive Officer for a one-year term commencing February 18, 2011. The Company is required under the Employment Agreement to use its commercially reasonable efforts to have Dr. Singh continue to serve as a member of the Companys Board of Directors during the term of the Employment Agreement. The Employment Agreement automatically renews on the one-year anniversary date of the effective date of February 18, 2011 of each year thereafter for successive one-year terms unless terminated by either party.
The Employment Agreement provides for an annual base salary of $315,000. In addition, provided that Dr. Singh continues to serve as the Companys President and Chief Executive Officer for the entire one-year term of the Employment Agreement, the Company will pay Dr. Singh a discretionary cash bonus of up to $100,000 upon the attainment of certain corporate goals.
The Employment Agreement also provides Dr. Singh a seven-year incentive stock option grant to purchase 270,000 shares of common stock under the Companys 2006 Equity Incentive Plan (the Plan) at an exercise price of $2.25 per share, which was the closing price of the Companys common stock on the date of grant. The option will vest as follows; (i) 20,000 shares on February 17, 2012, (ii) 50,000 shares on February 17, 2013, (iii) 50,000 shares on February 17, 2014, (iv) 50,000 shares upon the Company attaining a market capitalization of at least $100 million for ten consecutive trading dates, (v) 50,000 shares upon the Company attaining a market capitalization of at least $150 million for ten consecutive trading days and (vi) 50,000 shares upon the Company attaining a market capitalization of at least $200 million for ten consecutive trading days. The option may be exercised during the term that Dr. Singh provides services to the Company and for twelve months after termination for any reason except termination for cause by the Company, provided that such exercise is within the seven-year term of the option.
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In the event that the Company terminates the Employment Agreement without cause, then (i) the Company upon such termination will be required to make a lump sum payment to Dr. Singh equal to six months of his base annual salary, (ii) any stock options granted to Dr. Singh, to the extent vested, will be retained by Dr. Singh and will be exercisable on the terms described above, and (3) the vesting of an additional number of shares subject to all options granted to Dr. Singh equal to 50% of all shares subject to such options that vest based solely on the passage of time and that have not already vested will immediately accelerate and will be exercisable on the terms described above. If Dr. Singh terminates his employment for good reason as defined in the Employment Agreement, he will receive the severance benefits described in the preceding sentence, except that 100% of his options will vest if his employment terminates for good reason following a merger or similar corporate transaction in which the Company is not the surviving entity and the surviving entity does not offer Dr. Singh an executive position at a compensation level at least equal to his then compensation under the Employment Agreement.
Employment Agreement with James Bender
On May 10, 2011, the Company entered into an Employment Agreement, effective as of February 1, 2011, with Dr. James Bender pursuant to which Dr. Bender will continue to serve on a full-time basis as the Companys Vice President Product Development and Manufacturing for a one-year term commencing February 1, 2011. The Employment Agreement automatically renews on the one-year anniversary date of the effective date of February 1, 2011 of each year thereafter for successive one-year terms unless terminated by either party.
The Employment Agreement provides for an annual base salary of $175,000. In addition, provided that Dr. Bender continues to serve as the Companys Vice President Product Development and Manufacturing for the entire one-year term of the Employment Agreement, the Company will pay Dr. Bender a discretionary cash bonus of up to $35,000 upon the attainment of certain corporate goals.
The Employment Agreement also provides Dr. Bender a seven-year incentive stock option grant to purchase 120,000 shares of common stock under the Plan at an exercise price of $2.25 per share, which was the closing price of the Companys common stock on the date of grant. The option will vest as to (i) 60,000 shares in three annual installments of 20,000 shares each, with the first installment to vest on January 31, 2012; (ii) 20,000 shares upon the Company attaining a market capitalization of at least $100 million for ten consecutive trading dates; (iii) 20,000 shares upon the Company attaining a market capitalization of at least $150 million for ten consecutive trading dates; and (iv) 20,000 shares upon the Company attaining a market capitalization of at least $200 million for ten consecutive trading dates. The option may be exercised during the term that Dr. Bender provides services to the Company and for twelve months after termination for any reason except termination for cause by the Company, provided that such exercise is within the seven-year term of the option.
In the event that the Company terminates the Employment Agreement without cause, then (i) the Company upon such termination will be required to make a lump sum payment to Dr. Bender equal to six months of his base annual salary, (ii) any stock options granted to Dr. Bender, to the extent vested, will be retained by Dr. Bender and will be exercisable on the terms described above, and (iii) the vesting of an additional number of shares subject to all options granted to Dr. Bender equal to 50% of all shares subject to such options that vest solely on the passage of time and that have not already vested will immediately accelerate and will be exercisable on the terms described above. If Dr. Bender terminates his employment for good reason as defined in the Employment Agreement, he will receive the severance benefits described in the preceding sentence, except that 100% of his options will vest if his employment terminates for good reason following a merger or similar corporate transaction in which the Company is not the surviving entity and the surviving entity does not offer Dr. Bender an executive position at a compensation level at least equal to his then compensation under the Employment Agreement.
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Agreement with John Yu
On May 10, 2011, the Company entered into an Agreement, effective as of March 1, 2011, with Dr. John Yu pursuant to which Dr. Yu will continue to serve as the Companys Chief Scientific Officer for a one-year term commencing March 1, 2011. The term of this Agreement will automatically renew on the one-year anniversary date of the Agreement each year after March 1, 2011 for successive one-year terms unless either party terminates. Dr. Yu may also terminate the Agreement at any time upon 60 days notice.
The Agreement provides for an annual base salary of $70,000. In addition, Dr. Yu will receive a bonus of $15,000 each (a maximum total of $30,000) upon and provided that the Company achieves each of the following milestones within one year from the March 1, 2011: (i) enrollment of 75 patients in the Phase II trial of ICT-107 and (ii) filing of an IND for either a new indication for ICT-107 or for another product candidate of the Company.
The Agreement also provides Dr. Yu a seven-year incentive stock option grant to purchase 50,000 shares of common stock under the Plan at an exercise price of $[1.89] per share, which was the closing price of the Companys common stock on the date of grant. The option will vest in three equal annual installments, with the first vesting date to be February 29, 2012. The option may be exercised during the term that Dr. Yu provides services to the Company and for twelve months after termination for any reason except termination without cause by Dr. Yu or termination for cause by the Company, provided that such exercise is within the seven-year term of the option. All of the options granted to Dr. Yu will vest if his services terminate following a merger or similar corporate transaction in which the Company is not the surviving entity and the surviving entity does not offer Dr. Yu an executive position at a compensation level at least equal to his then compensation level under the Agreement.
Item 6. | Exhibits |
Exhibit No. | Description | |
4.1 | Form of Warrant issued to participants in the February 2011 private placement to purchase shares of common stock of ImmunoCellular Therapeutics, Ltd. (1) | |
10.1 | Purchase Agreement dated as of February 22, 2011 by and between the Company and each investor named therein. (1) | |
10.2 | Registration Rights Agreement dated as of February 22, 2011, by and among the Company and the investors named therein. (1) | |
10.3 | Sponsored Research and Vaccine Production Agreement dated January 1, 2011 between the Trustees of the University of Pennsylvania and ImmunoCellular Therapeutics, Ltd. (2) | |
31.1 | Certification of the Registrants Principal Executive Officer under Exchange Act Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
31.2 | Certification of the Registrants Principal Financial Officer under Exchange Act Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
32.1 | Certification of the Registrants Principal Executive Officer under 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
32.2 | Certification of the Registrants Principal Financial Officer under 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.] |
| Certain portions of the exhibit have been omitted based upon a request for confidential treatment filed by us with the Securities and Exchange Commission. The omitted portions of the exhibit have been separately filed by us with the Securities and Exchange Commission. |
(1) | Previously filed by us on February 25, 2011 as an exhibit to our current report on Form 8-K and incorporated herein by reference. |
(2) | Previously filed by us on March 31, 2011 as an exhibit to our Annual Report on Form 10-K and incorporated herein by reference. |
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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.
Dated: May 16, 2011 | IMMUNOCELLULAR THERAPEUTICS, LTD. | |||
By: | /s/ Manish Singh | |||
Name: Manish Singh, Ph.D. Title: President and Chief Executive Officer (Principal Executive Officer) |
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IMMUNOCELLULAR THERAPEUTICS, LTD.
FORM 10-Q FOR QUARTER ENDED MARCH 31, 2011
Exhibit No. | Description | |
4.1 | Form of Warrant issued to participants in the February 2011 private placement to purchase shares of common stock of ImmunoCellular Therapeutics, Ltd. (1) | |
10.1 | Purchase Agreement dated as of February 22, 2011 by and between the Company and each investor named therein. (1) | |
10.2 | Registration Rights Agreement dated as of February 22, 2011, by and among the Company and the investors named therein. (1) | |
10.3 | Sponsored Research and Vaccine Production Agreement dated January 1, 2011 between the Trustees of the University of Pennsylvania and ImmunoCellular Therapeutics, Ltd. (2) | |
31.1 | Certification of the Registrants Principal Executive Officer under Exchange Act Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
31.2 | Certification of the Registrants Principal Financial Officer under Exchange Act Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
32.1 | Certification of the Registrants Principal Executive Officer under 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
32.2 | Certification of the Registrants Principal Financial Officer under 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.] |
| Certain portions of the exhibit have been omitted based upon a request for confidential treatment filed by us with the Securities and Exchange Commission. The omitted portions of the exhibit have been separately filed by us with the Securities and Exchange Commission. |
(1) | Previously filed by us on February 25, 2011 as an exhibit to our current report on Form 8-K and incorporated herein by reference. |
(2) | Previously filed by us on March 31, 2011 as an exhibit to our Annual Report on Form 10-K and incorporated herein by reference. |
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