EOM Pharmaceutical Holdings, Inc. - Quarter Report: 2008 June (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 June 30, 2008
¨ | 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
(Registrant s telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all required reports 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 is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company.
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 12,682,493 shares of its common stock outstanding as of August 11, 2008.
Table of Contents
ImmunoCellular Therapeutics, Ltd.
FORM 10-Q
Page | ||||
PART I |
FINANCIAL INFORMATION | 1 | ||
Item 1. |
Financial Statements | 1 | ||
Condensed Balance Sheets as of December 31, 2007 and June 30, 2008 (unaudited) |
1 | |||
2 | ||||
3 | ||||
4 | ||||
5 | ||||
Item 2. |
Managements Discussion and Analysis of Financial Condition and Results of Operations. |
13 | ||
Item 3. |
17 | |||
Item 4. |
17 | |||
PART II |
OTHER INFORMATION | 17 | ||
Item 1. |
Legal Proceedings | 17 | ||
Item 1A. |
Risk Factors | 18 | ||
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds | 20 | ||
Item 3. |
Defaults Upon Senior Securities | 20 | ||
Item 4. |
Submission of Matters to a Vote of Security Holders | 20 | ||
Item 5. |
Other Information | 20 | ||
Item 6. |
Exhibits | 20 | ||
21 | ||||
22 |
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FINANCIAL INFORMATION
Item 1. | Financial Statements |
ImmunoCellular Therapeutics, Ltd.
(A Development Stage Company)
Condensed Balance Sheets
December 31, 2007 |
June 30, 2008 |
|||||||
(unaudited) | ||||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 5,040,824 | $ | 3,962,503 | ||||
Other assets |
29,540 | 100,395 | ||||||
Total current assets |
5,070,364 | 4,062,898 | ||||||
Fixed assets, net |
| 7,920 | ||||||
Other assets |
100 | 7,358 | ||||||
Total assets |
$ | 5,070,464 | $ | 4,078,176 | ||||
Liability and Shareholders Equity (Deficit) |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 30,196 | $ | 72,713 | ||||
Accrued liabilities |
42,559 | 27,498 | ||||||
Total current liabilities |
72,755 | 100,211 | ||||||
Commitments and contingencies |
| | ||||||
Shareholders equity (deficit): |
||||||||
Common stock, $0.0001 par value; 74,000,000 shares authorized; 11,782,493 shares and 12,682,493 shares issued and outstanding as of December 31, 2007 and June 30, 2008, respectively. |
11,782 | 12,682 | ||||||
Preferred stock $0.0001 par value, 1,000,000 shares authorized; 0 shares outstanding as of December 31, 2007 and June 30, 2008. |
| | ||||||
Additional paid in capital |
14,011,138 | 14,789,595 | ||||||
Deficit accumulated during the development stage |
(9,025,211 | ) | (10,824,312 | ) | ||||
Total shareholders equity (deficit) |
4,997,709 | 3,977,965 | ||||||
Total liabilities and shareholders equity |
$ | 5,070,464 | $ | 4,078,176 | ||||
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 June 30, 2007 |
For the Three Months Ended June 30, 2008 |
For the Six Months Ended June 30, 2007 |
For the Six Months Ended June 30, 2008 |
February 25, 2004 (Inception) to June 30, 2008 |
||||||||||||||||
Revenues |
$ | | $ | | $ | | $ | | $ | | ||||||||||
Expenses: |
||||||||||||||||||||
Research and development |
65,571 | 183,701 | 65,571 | 938,094 | 1,946,433 | |||||||||||||||
Merger costs |
| | | | 73,977 | |||||||||||||||
Stock based compensation |
56,450 | 96,191 | 1,153,650 | 290,357 | 5,690,716 | |||||||||||||||
General and administrative |
239,211 | 407,164 | 457,772 | 658,044 | 2,123,674 | |||||||||||||||
Total expenses |
361,232 | 687,056 | 1,676,993 | 1,886,495 | 9,834,800 | |||||||||||||||
Loss before other income and income taxes |
(361,232 | ) | (687,056 | ) | (1,676,993 | ) | (1,886,495 | ) | (9,834,800 | ) | ||||||||||
Interest income |
48,978 | 37,693 | 65,914 | 87,394 | 279,488 | |||||||||||||||
Change in fair value of warrant liability |
515,800 | | (1,456,200 | ) | | (1,269,000 | ) | |||||||||||||
Income (loss) before income taxes |
203,546 | (649,363 | ) | (3,067,279 | ) | (1,799,101 | ) | (10,824,312 | ) | |||||||||||
Income taxes |
| | | | | |||||||||||||||
Net income (loss) |
$ | 203,546 | $ | (649,363 | ) | $ | (3,067,279 | ) | $ | (1,799,101 | ) | $ | (10,824,312 | ) | ||||||
Weighted average number of shares: |
||||||||||||||||||||
Basic |
11,065,345 | 12,598,049 | 9,903,673 | 12,395,753 | 8,763,904 | |||||||||||||||
Diluted |
13,461,907 | 12,598,049 | 9,903,673 | 12,395,753 | 8,763,904 | |||||||||||||||
Earnings (loss) per share: |
||||||||||||||||||||
Basic |
$ | 0.02 | $ | (0.05 | ) | $ | (0.31 | ) | $ | (0.15 | ) | $ | (1.24 | ) | ||||||
Diluted |
$ | 0.02 | $ | (0.05 | ) | $ | (0.31 | ) | $ | (0.15 | ) | $ | (1.24 | ) | ||||||
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 (Deficit)
Common Stock | Additional Paid In Capital |
Deficit Accumulated During the Development Stage |
Total | ||||||||||||||||
Shares | Amount | ||||||||||||||||||
Initial capitalization at $0.00002 per share |
6,256,500 | $ | 97 | $ | | $ | | $ | 97 | ||||||||||
Common stock issued for cash during 2004 at $0.00078 per share |
193,500 | 150 | | | 150 | ||||||||||||||
Net loss |
| | | (11,741 | ) | (11,741 | ) | ||||||||||||
Balance at December 31, 2004 |
6,450,000 | 247 | | (11,741 | ) | (11,494 | ) | ||||||||||||
Common stock issued for cash during 2005 at $0.19 per share |
387,000 | 6,590 | 68,410 | | 75,000 | ||||||||||||||
Common stock issued for cash during 2005 at $0.32 per share |
154,800 | 155 | 49,845 | | 50,000 | ||||||||||||||
Common stock issued for research and development during 2005 at $0.99 per share |
154,800 | 155 | 152,605 | | 152,760 | ||||||||||||||
Net loss |
| | | (246,004 | ) | (246,004 | ) | ||||||||||||
Balance at December 31, 2005 |
7,146,600 | 7,147 | 270,860 | (257,745 | ) | 20,262 | |||||||||||||
Common stock issued for services during 2006 at $0.50 per share |
73,093 | 73 | 36,473 | | 36,546 | ||||||||||||||
Common stock issued for cash during 2006 in private placements at $1.00 per share, net of redemptions |
1,510,000 | 1,510 | 547,890 | | 549,400 | ||||||||||||||
Common stock issued for research and development during 2006 at $1.00 per share |
694,000 | 694 | 693,306 | | 694,000 | ||||||||||||||
Shares issued in connection with reverse merger |
825,124 | 825 | (825 | ) | | | |||||||||||||
Shares cancelled in connection with the sale of OMI |
(2,059,100 | ) | (2,059 | ) | (62,941 | ) | | (65,000 | ) | ||||||||||
Exercise of stock options |
10,062 | 10 | 3,512 | | 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 | 8,200 | 5,591,920 | (5,410,458 | ) | 189,662 | |||||||||||||
Common stock issued for cash during 2007 in private placements at $1.50 per share |
3,531,603 | 3,531 | 4,888,955 | | 4,892,486 | ||||||||||||||
Exercise of stock options |
51,111 | 51 | (51 | ) | | | |||||||||||||
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 | 11,782 | 14,011,138 | (9,025,211 | ) | 4,997,709 | |||||||||||||
Common stock issued for research and development during 2008 at $0.53 per share (unaudited) |
800,000 | 800 | 423,200 | | 424,000 | ||||||||||||||
Common stock issued for research and development during 2008 at $0.65 per share (unaudited) |
100,000 | 100 | 64,900 | | 65,000 | ||||||||||||||
Stock based compensation (options) (unaudited) |
| | 290,357 | | 290,357 | ||||||||||||||
Net loss (unaudited) |
| | | (1,799,101 | ) | (1,799,101 | ) | ||||||||||||
Balance at June 30, 2008 (unaudited) |
12,682,493 | $ | 12,682 | $ | 14,789,595 | $ | (10,824,312 | ) | $ | 3,977,965 | |||||||||
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 Six Months Ended June 30, 2007 |
For the Six Months Ended June 30, 2008 |
February 25, 2004 (Inception) to June 30, 2008 |
||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (3,067,279 | ) | $ | (1,799,101 | ) | $ | (10,824,312 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
Depreciation and amortization |
| 591 | 591 | |||||||||
Change in fair value of warrant liability |
1,456,200 | | 1,269,000 | |||||||||
Stock-based compensation |
1,153,650 | 290,357 | 5,690,716 | |||||||||
Common stock issued for services |
| | 36,546 | |||||||||
Common stock issued for research and development |
| 489,000 | 1,335,760 | |||||||||
Changes in assets and liabilities: |
||||||||||||
Other assets |
(63,325 | ) | (78,113 | ) | (107,753 | ) | ||||||
Accounts payable |
(17,750 | ) | 42,517 | 72,713 | ||||||||
Accrued liabilities |
30,832 | (15,061 | ) | 27,498 | ||||||||
Net cash used in operating activities |
(507,673 | ) | (1,069,810 | ) | (2,499,241 | ) | ||||||
Cash flows from investing activities: |
||||||||||||
Purchase of property and equipment |
| (8,511 | ) | (48,511 | ) | |||||||
Cash paid for sale of OMI |
| | (25,000 | ) | ||||||||
Net cash used in investing activities |
| (8,511 | ) | (73,511 | ) | |||||||
Cash flows from financing activities: |
||||||||||||
Exercise of stock options |
| | 3,522 | |||||||||
Proceeds from issuance of common stock under private placements |
4,892,486 | | 6,406,486 | |||||||||
Proceeds from issuance of common stock |
| | 125,247 | |||||||||
Net cash provided by financing activities |
4,892,486 | | 6,535,255 | |||||||||
Increase (decrease) in cash |
4,384,813 | (1,078,321 | ) | 3,962,503 | ||||||||
Cash at beginning of period |
1,060,341 | 5,040,824 | | |||||||||
Cash at end of period |
$ | 5,445,154 | $ | 3,962,503 | $ | 3,962,503 | ||||||
Supplemental non-cash financing activities: |
||||||||||||
Reclassification of warrant derivative liability to additional paid-in capital |
$ | 2,233,600 | $ | | $ | 2,233,600 | ||||||
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
In January 2006, Spectral Molecular Imaging, Inc., a Nevada corporation (SMI) that was incorporated and commenced operations on February 25, 2004, merged with Patco Industries, Ltd., which had no operations, assets or liabilities at the time of the merger. For accounting purposes, the financial statements of Patco Industries, Ltd. (now known as ImmunoCellular Therapeutics, Ltd.) reflect the operations of SMI (the Company).
In May 2006, the Company decided to suspend its research and development activities on its spectral imaging technology, and on September 11, 2006, the Company sold all of the outstanding capital stock of SMI to Dr. Daniel Farkas, a co-founder of SMI and inventor of this technology. In November 2006, the Company acquired from Cedars-Sinai Medical Center (Cedars-Sinai) an exclusive, worldwide license for a cancer vaccine therapy technology that the Company is developing.
On February 14, 2008, the Company entered into an Agreement with Molecular Discoveries LLC (Molecular Discoveries), covering the Companys acquisition of certain monoclonal antibody related technology owned by Molecular Discoveries and completed the acquisition of the technology on that date. The Molecular Discoveries agreement also was acknowledged and agreed to by Dr. Cohava Gelber, an inventor of the technology acquired by the Company under this agreement and an equity owner of Molecular Discoveries.
The technology acquired under the Molecular Discoveries agreement and now owned by the Company consists of (i) a platform technology referred to by Molecular Discoveries as DIAAD for the potentially rapid discovery of monoclonal antibodies to detect and treat cancer and other chronic diseases and (ii) certain monoclonal antibody candidates for the potential detection and treatment of multiple myeloma, small cell lung, pancreatic and ovarian cancers. The monoclonal antibodies are covered by issued patents and pending patent applications in the fields of multiple myeloma, small cell lung and ovarian cancers.
The Company is commencing the initial phase of development of a diagnostic/prognostic product for small cell lung cancer and a therapeutic product for the treatment of small cell lung and pancreatic cancers, based upon the acquired monoclonal antibody candidates. The monoclonal antibody technology is at a pre-clinical stage of development and will require further development before an IND can potentially be filed for human testing of any of the acquired product candidates. See Note 6.
Interim Results
The accompanying condensed financial statements at June 30, 2008 and for the three and six month periods ended June 30, 2007 and 2008 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, 2007 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 2008 financial statement presentation. The financial statements should be read in conjunction with the Companys audited financial statements in its Form 10-KSB for the year ended December 31, 2007. 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.
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2. Summary of Significant Accounting Policies
Cash and Cash Equivalents The Company considers all highly liquid debt instruments with an original maturity of 90 days or less to be cash equivalents. The Company had $5,026,780 and $3,903,173 of cash equivalents, consisting of certificates of deposit with an original maturity of 90 days or less, at December 31, 2007 and June 30, 2008, respectively.
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. 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.
Research and Development Costs - Research and development expenses consist of costs incurred for direct research and are expensed as incurred. The Company expenses acquired in-process research and development (IPR&D) upon acquisition as it represents incomplete research and development that had not reached technological feasibility and had no alternative future use as of the date of acquisition. Technological feasibility is established when an enterprise has completed all planning, designing, coding, and testing activities that are necessary to establish that a product can be produced to meet its design specifications including functions, features, and technical performance requirements. On February 14, 2008, the Company recorded an IPR&D charge of $688,250 based on the cash paid plus the value of the shares of the Companys common stock issued at the date of acquisition for the Molecular Discoveries technology. On June 16, 2008, the Company recorded an IPR&D charge of $65,000 based upon the value of the 100,000 shares of the Companys common stock issued in connection with the First Amendment to Exclusive License Agreement with Cedars-Sinai (see Note 4).
Stock Based Compensation In December 2004, the Financial Accounting Standards Board (FASB) issued SFAS 123R, Share Based Payment: An Amendment of FASB Statements No. 123 and 95 (SFAS 123R). This statement requires that the cost resulting for all share-based payment transactions be recognized in the Companys consolidated financial statements. In addition, in March 2005 the SEC released SEC Staff Accounting Bulletin No. 107, Share-Based Payment (SAB 107). SAB 107 provides the SECs staffs position regarding the application of SFAS 123R and certain SEC rules and regulations, and also provides the staffs views regarding the valuation of share-based payment arrangements for public companies. Generally, the approach in SFAS 123R is similar to the approach described in SFAS 123. However, SFAS 123R requires all share-based payments to employees, including grants of employee stock options, to be recognized in the statement of operations based on their fair values. Pro forma disclosure of fair value recognition, as prescribed under SFAS 123, is no longer an alternative.
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Fair value was estimated at the date of grant using the Black-Scholes pricing model, with the following weighted average assumptions:
Six Months Ended March 30, 2007 |
Six Months Ended June 30, 2008 |
|||||
Risk-free interest rate |
4.75 | % | 2.80 | % | ||
Expected dividend yield |
None | None | ||||
Expected life |
3.0 years | 4.0 years | ||||
Expected volatility |
100.0 | % | 92.0 | % |
The weighted-average grant-date fair value of options granted during the six months ended June 30, 2007 and June 30, 2008 was $0.71 and $0.39, respectively.
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. We have not declared or paid any dividends and do 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 shares 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 June 30, 2008, we had 61.3 million shares of unissued shares of 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.
Income Taxes - The Company accounts for federal and state income taxes in accordance with SFAS No. 109, Accounting for Income Taxes. Under the liability method specified by SFAS No. 109, 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. In June 2006, the Financial Accounting Standards Board (FASB) issued FASB Interpretation (FIN) No. 48, Accounting for Uncertainty in Income Taxes (FIN 48), which clarifies the accounting for uncertainty in income taxes recognized in an entitys financial statements in accordance with SFAS No. 109. FIN 48 prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. In addition, FIN 48 provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. FIN 48 is effective for fiscal years beginning after December 15, 2006. The Company adopted FIN 48 on January 1, 2007. The adoption of FIN 48 did not have a material impact on the Companys financial position or results of operations. Upon adoption of FIN 48 and as of June 30, 2008, the Company had no unrecognized tax benefits recorded.
The Company recognizes interest and penalties for uncertain tax positions in income tax expense. Upon adoption and as of June 30, 2008, the Company had no interest and penalty accrual or expense.
Fair Value of Financial Instruments - The carrying amounts reported in the balance sheets for cash and accounts payable approximate their fair values.
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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 15,768,917 shares at June 30, 2008. Common share equivalents at June 30, 2007 totaled 2,396,562 shares which were included in the diluted weighted average number of shares outstanding for the three months ended June 30, 2007.
Recently Issued Accounting Standards In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements, or SFAS 157, which provides guidance on how to measure assets and liabilities that use fair value. This statement clarifies the principle that fair value should be based on the assumptions market participants would use when pricing an asset or liability and establishes a fair value hierarchy that prioritizes the information used to develop those assumptions. SFAS 157 will apply whenever another generally accepted accounting principle requires, or permits, assets or liabilities to be measured at fair value but does not expand the use of fair value to any new circumstances. This statement will also require additional disclosures in both annual and quarterly reports. SFAS 157 is effective for fiscal years beginning after November 2007. On January 1, 2008, we adopted SFAS 157 and the impact on our financial statements was not material.
In February 2007, the FASB issued Statement 159, The Fair Value Option for Financial Assets and Financial Liabilities Including an Amendment of SFAS 115 (Statement 159), which permits but does not require the Company to measure financial instruments and certain other items at fair value. Unrealized gains and losses on items for which the fair value option has been elected are reported in earnings. This statement is effective for financial statements issued for fiscal years beginning after November 15, 2007. On January 1, 2008, we adopted SFAS 159 and the impact on our financial statements was not material.
In November 2007, the EITF reached a consensus on Issue 07-1. EITF 07-1, Accounting for Collaborative Arrangements Related to the Development and Commercialization of Intellectual Property, is focused on how the parties to a collaborative agreement should account for costs incurred and revenue generated on sales to third parties, how sharing payments pursuant to a collaborative agreement should be presented in the income statement and certain related disclosure questions. EITF 07-1 is effective for periods beginning after December 15, 2008. We are evaluating the requirements of these issues and have not yet determined the impact on the financial statements.
In December 2007, the FASB issued Statement No. 141(R), Business Combinations (Statement 141(R)), a replacement of FASB Statement No. 141. Statement 141(R) is effective for fiscal years beginning on or after December 15, 2008 and applies to all business combinations. Statement 141(R) provides that, upon initially obtaining control, an acquirer shall recognize 100% of the fair values of acquired assets, including goodwill, and assumed liabilities, with only limited exceptions, even if the acquirer has not acquired 100% of its target. As a consequence, the current step acquisition model will be eliminated. Additionally, Statement 141(R) changes current practice, in part, as follows: (1) contingent consideration arrangements will be fair valued at the acquisition date and included on that basis in the purchase price consideration; (2) transaction costs will be expensed as incurred, rather than capitalized as part of the purchase price; (3) pre-acquisition contingencies, such as legal issues, will generally have to be accounted for in purchase accounting at fair value; and (4) in order to accrue for a restructuring plan in purchase accounting, the requirements in FASB Statement No. 146, Accounting for Costs Associated with Exit or Disposal Activities, would have to be met at the acquisition date. While there is no expected impact to our consolidated financial statements on the accounting for acquisitions completed prior to December 31, 2008, the adoption of Statement 141(R) on January 1, 2009 could materially change the accounting for business combinations consummated subsequent to that date.
On December 4, 2007, Statement of Financial Accounting Standards No. 160, Noncontrolling Interests in Consolidated Financial Statements, an amendment of ARB No. 51, or SFAS 160, was issued. This standard changes the accounting for and reporting of noncontrolling or minority interests in consolidated financial statements. The standard is effective January 1, 2009 however the presentation and disclosure requirements of SFAS 160 regarding noncontrolling interests shall be applied retrospectively. We are evaluating the impact, if any, this standard will have on our financial statements.
In May 2008, the FASB issued Statement of Financial Accounting Standards No. 162, The Hierarchy of Generally Accepted Accounting Principles, or SFAS 162. This standard identifies the source of accounting principles and the framework for selecting principles to be used in the preparation and presentation of financial statements in accordance with generally accepted accounting principles. SFAS 162 directs the hierarchy to the entity, rather than the independent auditors. This standard is effective 60 days after the Securities and Exchange Commission approves the Public Company Accounting Oversight Board amendments to remove the hierarchy of generally accepted accounting principles from the auditing standards. We do not anticipate that the adoption of this standard will have an effect on our consolidated financial statements.
Reclassifications Certain prior year items have been reclassified to conform to current year presentation.
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3. Property and Equipment
As of December 31, 2007 and June 30, 2008, the Company had none and $8,511 of equipment, respectively. Depreciation expense for the six months ended June 30, 2008 was $591. No equipment was placed into service prior to March 31, 2008; therefore, no depreciation was recorded in the six months ended June 30, 2007.
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 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, commencing a Phase II clinical trial for a product candidate by December 31, 2008 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 June 30, 2008, the Company has paid Cedars-Sinai a total of $125,000 in connection with the Phase I clinical trial.
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. 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 CD 133 epitope technology, which will be subject to the royalty and other terms of the License Agreement.
Legal Costs
At December 31, 2007 and June 30, 2008, the Company was indebted to a shareholder for legal services for $42,559 and $13,328, respectively, which are included in accrued expenses on the accompanying balance sheets. Legal services provided by the shareholder for the period from February 25, 2004 (date of inception) to June 30, 2008 was approximately $735,000.
Rent
From February 25, 2004 (date of inception) to October 29, 2007, the Company used on a rent-free basis office space of a shareholder. Such costs were immaterial to the financial statements and, accordingly, have not been reflected therein.
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5. Commitments and Contingencies:
Operating Lease
Effective March 1, 2008, the Company entered into a one-year lease, as amended, at a monthly rental rate of $3,604.
Employment Agreement
Effective as of February 18, 2008, the Company entered into an Employment Agreement with Dr. Manish Singh pursuant to which Dr. Singh will serve on a full-time basis as the Companys President and Chief Executive Officer for a one-year term. The Company is required under the Employment Agreement to use its commercially reasonable efforts to have Dr. Singh serve as a member of the Companys Board of Directors during the term of the Employment Agreement. The Employment Agreement provides for an annual base salary of $200,000, payable monthly, and a $100,000 bonus if the Company generates aggregate net financing proceeds of at least $5,000,000 during the term of the agreement and an additional bonus of $100,000 if the Company generates aggregate net financing proceeds of at least $10,000,000 during the term of the agreement. Pursuant to the Employment Agreement, the Company granted Dr. Singh a seven-year nonqualified stock option on February 18, 2008 under the Companys 2006 Equity Incentive Plan to purchase 600,000 shares of the Companys common stock at an exercise price of $1.00 per share. Pursuant to an amendment to the Employment Agreement, a portion of this option covering 327,972 shares is subject to cancellation in the event of, and may not be exercised unless and until, the Companys shareholders approve an increase in the authorized number of shares covered by the 2006 Equity Incentive Plan to at least 1,850,000 shares. The option vests in twelve equal monthly installments over the one-year term of the agreement. 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 seven-year term of the option.
Consulting Agreements
As contemplated by the Molecular Discoveries agreement, the Company entered into a consulting agreement with Dr. Gelber concurrently with the Companys acquisition of the monoclonal antibody related technology from Molecular Discoveries under which she will provide certain consulting services to the Company on a part-time basis in connection with its development of the acquired technology during the ten-month period from the closing of the acquisition. For these services, the Company (i) paid Dr. Gelber $30,000 per month for February 2008 and March 2008 and $10,000 per month for April 2008, and will pay $10,000 per month for May 2008, June 2008 and July 2008 (a total of $100,000 unless the Company terminates the consulting agreement prior to the expiration of its ten-month term), (ii) will pay Dr. Gelber a success payment of $50,000 if Dr. Gelber is able during the term of the consulting agreement to generate an interim analysis of pre-clinical data satisfactory to the Company that demonstrates the feasibility of a small cell lung cancer product candidate as a medical diagnostic and predictor of responders for this indication and (iii) issued Dr. Gelber a five-year option under the Companys stock option plan to purchase 75,000 shares of the Companys common stock at a purchase price of $0.53 per share equal to the closing price of the Companys common stock on the date of the closing of the acquisition, with such option to vest at the rate of 5,000 shares each month during the term of the consulting agreement and with 25,000 shares to vest upon generation of the interim analysis of pre-clinical data described above.
Effective as of November 5, 2007, the Company entered into a new consulting agreement with C. Kirk Peacock under which Mr. Peacock agreed to serve as Chief Financial Officer for a one-year term, subject to earlier termination by the Company or Mr. Peacock on 30 days notice. Mr. Peacock will provide his services to the Company on a part-time basis. Under the agreement with Mr. Peacock, Mr. Peacock will be paid $8,000 per month and was granted an option to purchase 50,000 shares of common stock, which will vest monthly over a one-year period, and exercisable within its term during the period Mr. Peacock provides services to the Company and for 24 months after the grantee ceases providing services for any reason other than termination by the Company for cause.
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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
Equity Investment
On June 16, 2008, the Company entered into the Amendment of the License Agreement 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. 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 CD 133 epitope technology, which will be subject to the royalty and other terms of the License Agreement.
On February 14, 2008, the Company acquired from Molecular Discoveries, the intellectual property and related assets comprising the technology the compensation consisted of (i) the issuance of 800,000 shares of the Companys common stock to Molecular Discoveries and (ii) the reimbursement by the Company to Molecular Discoveries or its managing member of $250,000 of previously incurred patent expenses. The Company will be required to register the shares issued to Molecular Discoveries, but Molecular Discoveries has agreed that it will not publicly resell any of these shares until after such registration is completed and not more than 100,000 shares in any 90-day period thereafter. To secure Molecular Discoveries potential obligations to the Company under the Molecular Discoveries agreement, all of the shares also will be placed in escrow, with 400,000 shares subject to release after one year and the balance after two years from the closing of the transaction.
Private Placements
In May 2007, the Company raised $2,262,252 (before offering expenses) from the sale of 1,508,168 shares of common stock and warrants to purchase 1,508,168 shares of common stock at $2.50 per share, to various investors in a private placement. The warrants have a term of two years from the date of issuance.
In April 2007, the Company raised $1,535,153 (before offering expenses) from the sale of 1,023,435 shares of common stock and warrants to purchase 1,023,435 shares of common stock at $2.50 per share, to various investors in a private placement. The warrants have a term of two years from the date of issuance.
In April 2007, the Company raised $300,000 (before offering expenses) from the sale of 200,000 shares of common stock and warrants to purchase 333,334 shares of common stock at $2.50 per share, to an institutional investor in a private placement. The warrants have a term of two years from the date of issuance.
In February 2007, the Company raised $1,200,000 (before offering expenses) from the sale of 800,000 shares of common stock and warrants to purchase 1,333,334 shares of common stock at $2.50 per share, to an institutional investor in a private placement. The warrants have a term of two years from the date of issuance.
In accordance with FAS 133 Accounting for Derivative Instruments and Hedging Activities, EITF 00-19 Accounting for Derivative Financial Instruments Indexed to and Potentially Settled in a Companys Own Stock and EITF 05-04 The Effect of a Liquidated Damages Clause on a Freestanding Financial Instrument. Subject to EITF Issue No. 00-19, the Company did not allocate amounts to the warrants issued in connection with the 2007 private placements that represent a derivative liability as no monetary damages will result as long as the Company uses its best efforts to register the shares underlying the warrants.
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Stock Option Plan
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 June 30, 2008, the Company has reserved 3,400,000 shares of common stock for issuance under the plan, subject to stockholder approval, and options to purchase 1,872,910 common shares have been granted under the stock option 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 a Board member.
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 under the Plan during the six months ended June 30, 2008:
Options | Weighted Average Exercise Price |
Weighted Average Remaining Contractual Term |
Aggregate Intrinsic Value | ||||||||
Outstanding December 31, 2007 |
8,645,084 | $ | 1.02 | ||||||||
Granted |
730,000 | $ | 0.93 | ||||||||
Exercised |
| $ | | ||||||||
Forfeited or expired |
(18,750 | ) | $ | 1.30 | |||||||
Outstanding June 30, 2008 |
9,356,334 | $ | 1.01 | 7.8 | $ | 20,066 | |||||
Vested or expected to vest at June 30, 2008 |
8,785,920 | $ | 1.01 | 7.8 | $ | 20,066 |
As of June 30, 2008, the total unrecognized compensation cost related to unvested stock options amounted to $209,263, which will be amortized over the weighted-average remaining requisite service period of less than one year.
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Warrant Derivatives
In connection with the Companys January 2006 private placement, the Company issued to the investors warrants to purchase 1,400,000 shares of the Companys common stock at $2.50 per share and paid a finders fee in the form of warrants to purchase 300,000 shares of the Companys common stock at $0.15 per share. Of the total proceeds from the January 2006 private placement, net of repurchases, $964,600 was allocated to the freestanding warrants associated with the units based upon the fair value of the warrants. The assumptions used in the Black Scholes model for determining the initial fair value of the warrants were as follows: (1) dividend yield of 0%; (2) expected volatility of 100%, (3) risk-free interest rate of 4.50%, and (4) contractual life of 3 years. In accordance with FAS 133 Accounting for Derivative Instruments and Hedging Activities, EITF 00-19 Accounting for Derivative Financial Instruments Indexed to and Potentially Settled in a Companys Own Stock and EITF 05-04 The Effect of a Liquidated Damages Clause on a Freestanding Financial Instrument Subject to EITF Issue No. 00-19, the amounts allocated to the warrants represented a derivative liability that was recorded in the Companys prior balance sheets. For the six months ended June 30, 2007, the Company recorded a change in fair value of warrant derivatives of $(1,456,200). Upon the declaration of effectiveness of the registration of the common shares underlying the warrants in June 2007, the carrying value of warrant derivatives was reclassified to additional paid in capital in the accompanying balance sheet, as the warrants no longer required derivative liability treatment under EITF Issue No. 00-19.
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-KSB for the year ended December 31, 2007 and the Risk Factors section set forth in Item 1A of Part II of this Report. 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
In January 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 will be developing for the potential treatment of brain tumors and other forms of cancer and neurodegenerative disorders. We are currently funding a Phase I clinical trial of a vaccine product candidate for the treatment of glioblastoma multiforme based on this technology that we anticipate will be completed by the first half of 2009.
In February 2008, we acquired certain monoclonal antibody related technology owned by Molecular Discoveries LLC. This technology consists of (i) 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 (ii) certain monoclonal antibody candidates for the potential detection and treatment of multiple myeloma, small cell lung, pancreatic and ovarian cancers.
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 our lead vaccine product candidate, and have not generated any revenues. As a result, we have incurred operating losses and, as of June 30, 2008, we had an accumulated deficit of $10,824,312. We expect to incur significant research, development and administrative expenses before such time, if ever, that any of our products can be launched and revenues generated.
Critical Accounting Policies
Managements discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires 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 interim financial statements for the period ended June 30, 2008. 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 the Financial Accounting Standards Boards (FASB) Statement of Financial Accounting Standards (SFAS) No. 7, Accounting and Reporting by Development Stage Enterprises. We are devoting substantially all of our present efforts to research and development. All losses accumulated since inception have been 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. We expense acquired in-process research and development (IPR&D) upon acquisition as it represents incomplete research and development that had not reached technological feasibility and had no alternative future use as of the date of our acquisition. Technological feasibility is established when an enterprise has completed all planning, designing, coding, and testing activities that are necessary to establish that a product can be produced to meet its design specifications including functions, features, and technical performance requirements.
During the six months ended June 30, 2007 and 2008, we recorded an expense of $65,571 and $938,094, respectively, related to research and development activities. On June 16, 2008, we recorded a $65,000 IPR&D charge associated with the issuance of 100,000 common shares of our common stock to Cedars-Sinai for the exclusive license of an epitope to CD133 and certain related intellectual property. On February 14, 2008, we recorded an IPR&D charge of $688,250 based on the cash paid plus the value of the shares of our common stock issued at the date of acquisition for the Molecular Discoveries technology.
Stock-Based Compensation
In December 2004, the FASB issued SFAS 123R, Share Based Payment: An Amendment of FASB Statements No. 123 and 95 (SFAS 123R). This statement requires that the cost resulting from all share-based payment transactions be recognized in our consolidated financial statements. In addition, in March 2005 the Securities and Exchange Commission (the SEC) released SEC Staff Accounting Bulletin No. 107, Share-Based Payment (SAB 107), and later amended certain sections of SAB 107 by issuing SAB 110. SAB 107 and SAB 110 provides the SEC staffs position regarding the application of SFAS 123R and certain SEC rules and regulations, and also provides the SEC staffs views regarding the valuation of share-based payment arrangements for public companies. Generally, the approach in SFAS 123R is similar to the approach described in SFAS 123. However, SFAS 123R requires all share-based payments to employees, including grants of employee stock options, to be recognized in the statement of operations based on their fair values. Pro forma disclosure of fair value recognition, as prescribed under SFAS 123, is no longer an alternative.
In the first quarter of 2006, we adopted the fair value recognition provisions of SFAS 123R utilizing the modified-prospective-transition method, as prescribed by SFAS 123R. 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 in accordance with SFAS 123, and (b) compensation expense for all share-based payments granted subsequent to January 1, 2006, based on the grant-date fair value estimated in accordance with the provisions of SFAS 123R. 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 period for the six months ended June 30, 2007 and 2008, respectively. We incurred a net loss of $3,067,279 and $1,799,100 for the six months ended June 30, 2007 and 2008, respectively. We do not expect to generate any operating revenues during 2008.
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Expenses
General and administrative expenses for the six months ended June 30, 2007 and 2008 were $457,772 and $658,044, respectively. The increase in general and administrative expenses is primarily due to increased personnel and occupancy costs partially offset by a reduction in professional fees related to no new financings in 2008. Research and development expenses for the six months ended June 30, 2007 and 2008 were $65,571 and $938,094, respectively. The increase in research and development expenses is related to $688,250 in-process research and development costs associated with the acquired Molecular Discoveries technologies and to costs associated with our current Phase I clinical trial. We had $779,357 of non-cash expense for the six months ended June 30, 2008, consisting of $290,357 in stock based compensation and $489,000 paid in common stock for IPR&D, compared to $2,609,850 of non-cash expense consisted of $1,153,650 of stock based compensation and change in fair value of warrant liability of $1,456,200 for the six months ended June 30, 2007.
We expect our general and administrative expenses to increase significantly during 2008 as compared to 2007 as we expand the scope of our operations. We estimate that the cost of our research and development work will exceed $1,000,000 in 2008, and we may incur significant additional research and development expenses should we expand our research and development work on additional potential applications for our existing technologies or should we acquire additional technologies from one or more third parties.
Loss
We incurred a net loss of $3,067,279 and $1,799,101 for the six months ended June 30, 2007 and 2008, respectively.
Liquidity and Capital Resources
As of June 30, 2008, we had working capital of $3,962,687, compared to working capital of $4,997,609 on December 31, 2007. In 2007, we raised net proceeds of approximately $4,892,486 through the sale of our securities in private placements.
The estimated cost of completing the development of our lead vaccine product candidate and of obtaining all required regulatory approvals to market that product candidate is substantially greater than the amount of funds we currently have available. We believe that our existing cash balances will be sufficient to complete our current Phase I clinical trial and to fund our currently planned level of operations through at least June 2009, although there is no assurance that such proceeds will be sufficient for this purpose.
We do not have any bank credit lines. We currently plan to attempt to obtain additional financing through the sale of additional equity, although we may also in the future seek to obtain funding through strategic alliances with larger pharmaceutical or biomedical companies. We have not yet identified, and cannot be sure that we will be able to obtain any additional funding from either of these sources, or that the terms under which we may be able to obtain such funding will be beneficial to us. If we are unsuccessful or only partly successful in our efforts to secure additional financing, we may find it necessary to suspend or terminate some or all of our product development and other activities.
As of June 30, 2008, 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 $1,069,810 of cash in our operations for the six months ended June 30, 2008, compared to $507,673 for the six months ended June 30, 2007, as the non-cash portion of our net loss for the 2008 period was $779,357 and the non-cash portion of our net loss for the 2007 period was $2,609,850. We used $8,511 of cash in our investing activities for the six months ended June 30, 2008 and none for this purpose for the six months ended June 30, 2007. We received no cash from financing activities for the six months ended June 30, 2008 and $4,892,486 from the private placements of our securities that we completed during the six months ended June 30, 2007.
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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.
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 (i) our disclosure controls and procedures are 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.
OTHER INFORMATION
Item 1. | Legal Proceedings |
None.
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Item 1A. | Risk Factors |
There has been no material change in the Risk Factors set forth in the Risk Factors section of the Companys Form 10-KSB for the year ended December 31, 2007, except that the following risk factors have been updated:
As an early stage small company that will be competing against numerous large, established companies that have substantially greater financial, technical, manufacturing, marketing, distribution and other resources than us, we will be at a significant competitive disadvantage.
The pharmaceutical and biopharmaceutical industry is characterized by intense competition and rapid and significant technological changes and advancements. Many companies, research institutions and universities are doing research and development work in a number of areas similar to those that we focus on that could lead to the development of new products which could compete with and be superior to our product candidates.
Most of the companies with which we compete have substantially greater financial, technical, research, manufacturing, marketing, distribution and other resources than those of ours. A number of these companies may have or may develop technologies for developing products for treating various diseases, including brain cancers, that could prove to be superior to ours. We expect technological developments in the pharmaceutical and biopharmaceutical and related fields to occur at a rapid rate, and we believe competition will intensify as advances in these fields are made. Accordingly, we will be required to continue to devote substantial resources and efforts to research and development activities in order to potentially achieve and maintain a competitive position in this field. Products that we develop may become obsolete before we are able to market them or to recover all or any portion of our research and development expenses. We will be competing with respect to our products with companies that have significantly more experience and expertise in undertaking preclinical testing and human clinical trials with new or improved therapeutic products and obtaining regulatory approvals of such products. A number of these companies already market and may be in advanced phases of clinical testing of various drugs that will or may compete with our current product candidates or other future potential product candidates. Our competitors may develop or commercialize products more rapidly than we do or with significant advantages over any products we develop. Our competitors may therefore be more successful in commercializing their products than we are, which could adversely affect our competitive position and business.
In addition to larger pharmaceutical or biopharmaceutical companies that may develop different competing technologies or technologies within the cellular and stem cell field, we will be competing with a number of smaller biotechnology companies that are focused on cellular therapy and cancer vaccine technologies, which may include among others AVANT Therapeutics, Dendreon, Northwest Biotherapeutics, Antigenics, NeuralStem, Geron, NeuroNova, ReNeuron, Stemcells, Inc., Advanced Cell Technology and Osiris Therapeutics. We are aware that Dendreon and Northwest Biotherapeutics have conducted clinical trials with cancer vaccine product candidates utilizing dendritic cells (including a Northwest Biotherapeutics candidate for treating brain tumors), and AVANT Therapeutics is also currently conducting clinical trials to treat glioblastoma with their cancer vaccine. Other existing and new companies that may enter the field, may also be developing vaccines of this type.
Drugs targeting cancer stem cells is a new emerging field, and a number of companies are developing products that are in various stages of clinical or preclinical development. We will be competing with these companies, which may have more resources than us. This list may include among others ChemGenex, GlaxoSmithKline, Geron, Stemline Therapeutics, OncoMed Pharmaceuticals, Raven and Arius Research. In addition, a number of academic and research centers are doing research in this area which may be commercialized by new or existing companies.
A number of monoclonal antibody products currently are being marketed for the treatment of cancer, including Rituxan®, Herceptin®, Compath®, Avastin®, Erbitux®, Vectibix®, Zevatin®, and Bexxar®, and numerous other monoclonal antibody based products are under development for the treatment of cancer. Accordingly, our monoclonal antibody products, if marketed, can be expected to compete with our monoclonal antibody products (as well as other products for the treatment of cancer) that are well established and marketed by substantial organizations.
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Colleges, universities, governmental agencies and other public and private research organizations are becoming more active in seeking patent protection and licensing arrangements to collect royalties for use of technologies that they have developed, some of which may be directly competitive with our lead product candidate or any future product candidates. The governments of a number of foreign countries are aggressively investing in cellular therapy research and promoting such research by public and private institutions within those countries. These domestic and foreign institutions and governmental agencies, along with pharmaceutical and specialized biotechnology companies, also can be expected to compete with us in recruiting qualified scientific personnel.
Our patents may not protect the proprietorship of our products.
Our ability to compete successfully will depend significantly on our ability to defend patents that may have issued, obtain new patents, protect trade secrets and operate without infringing the proprietary rights of others or others infringing on our proprietary rights. Although Cedars-Sinai as our licensor has filed applications relative to our cancer vaccine technology, we are responsible going forward to prosecute these patent applications. We do not currently own or have licensed rights to any issued patents covering our cancer vaccine technology, and there is no guarantee that these patent applications will lead to issued patents.
Issuance of patents based upon the various patent applications licensed from Cedars-Sinai will depend upon the U.S. and foreign patent agencies being able to determine that the claims made in these applications were not already publicly known or were not obvious from prior published patents and literature, including the extensive previous vaccine work performed and published by Dr. John Yu and other researchers at Cedars-Sinai. One of the provisional applications in the licensed portfolio covered the use of a specific antigen, TRP-2, in vaccines. We have decided that in light of our present research interests and commercial strategies, as well as prior published literature, we will not pursue this application. Although TRP-2 is one of the antigens used in our lead vaccine product candidate, we have been seeking patent protection for this vaccine through our licensed multiple antigen patent application and not through the withdrawn TRP-2 patent application. The TRP-2 patent application did not cover in any material respect the technology incorporated in any other potential vaccine product candidate that we are currently contemplating for future development. Another patent application that we licensed from Cedars-Sinai and that we have been pursuing was recently rejected by the U.S. Patent and Trademark Office based on prior art. This patent application covers the treatment of brain and other cancers by a combination of a dendritic cell-based vaccine and chemotherapy. We are seeking patent protection for our lead vaccine product candidate primarily through our licensed multiple antigen patent application. While we are continuing to pursue claims in our recently rejected combination therapy application, we are not dependent on any of the claims in the combination therapy application being granted in order to complete the development of or to commercialize our lead vaccine product candidate or any other potential vaccine product that we are currently contemplating for future development.
Even if we are able to obtain patent protection for our lead vaccine product candidate or any of our other current or future product candidates, there is no guarantee that the coverage of these patents or the existing patents we own covering our monoclonal antibody based technology, will be sufficiently broad to protect us from competitors or that we will be able to enforce our patents against potential infringement by third parties. Patent litigation is expensive, and we may not be able to afford the costs. We may not become aware on a timely basis that products we are developing or marketing infringe the rights of others, nor may we be able to detect unauthorized use or take appropriate and timely steps to enforce our own intellectual property rights. Protecting our intellectual property rights may also consume significant management time and resources. Dr. John Yu, a co-inventor of our cellular-based therapy technology who serves as our Chairman of the Board, is employed by Cedars-Sinai, which may assert that future intellectual property generated by Dr. Yu belongs to that institution rather than to us, and we may be required to seek a license from Cedars-Sinai for any such rights. We acquired our monoclonal antibody related technology from Molecular Discoveries, but third parties who previously employed that companys lead scientist could potentially assert ownership claims to the technology. We do not have any issued patents or patent applications covering DIAAD and may not be able to protect this technology through any trade secrets that we may hold or future patents, if any, that we may seek to obtain.
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Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
The Company did not issue any unregistered securities during the six month period ended June 30, 2008 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. | Submission of Matters to a Vote of Security Holders |
None.
Item 5. | Other Information |
None.
Item 6. | Exhibits |
Exhibit No. |
Description | |
10.1 | Registration Rights Agreement dated April 14, 2008 by and between Molecular Discoveries LLC and ImmunoCellular Therapeutics, Ltd. (1) | |
10.2 | First Amendment to Exclusive License Agreement dated June 16, 2008, by and between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd. | |
10.3 | Amendment No. 4 to the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. dated June 24, 2008.* | |
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. |
* | Indicates a management contract or compensatory plan or arrangement. |
(1) | Previously filed by us on April 16, 2008 as an exhibit to our Form S-1 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: August 13, 2008 | 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 JUNE 30, 2008
Exhibit No. |
Description | |
10.1 | Registration Rights Agreement dated April 14, 2008 by and between Molecular Discoveries LLC and ImmunoCellular Therapeutics, Ltd. (1) | |
10.2 | First Amendment to Exclusive License Agreement dated June 16, 2008, by and between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd. | |
10.3 | Amendment No. 4 to the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. dated June 24, 2008.* | |
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. |
* | Indicates a management contract or compensatory plan or arrangement. |
(1) | Previously filed by us on April 16, 2008 as an exhibit to our Form S-1 and incorporated herein by reference. |
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