Prospectus Supplement No. 1 (to Prospectus dated October 6, 2009) |
Filed pursuant to Rule 424(b)(3) Registration Statement No. 333-160778 |
ADVENTRX PHARMACEUTICALS, INC.
• |
11,283 shares of 4.25660% Series D
Convertible Preferred Stock
|
• |
Warrants to Purchase up to 19,800,000 shares
of Common Stock
|
• |
79,800,000 shares of Common Stock Underlying
the Convertible Preferred Stock and the Warrants
|
This prospectus supplement should be read in conjunction with the prospectus dated October 6, 2009 (the “Prospectus”), which is to be delivered with this prospectus supplement. This prospectus supplement updates the information in the Prospectus. If there is any inconsistency between the information in the Prospectus and this prospectus supplement, you should rely on the information in this prospectus supplement.
Pursuant to the Prospectus, we offered up to $11,283,000 of our 4.25660% Series D Convertible Preferred Stock, or 11,283 shares based on a stated value of $1,000 per share, and warrants to purchase up to 19,800,000 shares of our common stock. Delivery of the convertible preferred stock and warrants was made on or about October 9, 2009. In addition, pursuant to the Prospectus, 79,800,000 shares of our common stock issuable upon conversion of the convertible preferred stock and exercise of the warrants were registered to permit their resale to the public by the purchasers of our convertible preferred stock and warrants. We are not selling the shares of common stock issuable upon conversion of the convertible preferred stock or exercise of the warrants, and therefore will not receive any proceeds from such sales, other than the exercise price, if any, to be received upon exercise of the warrants.
This prospectus supplement includes the following documents, as filed by us with the Securities and Exchange Commission:
• |
Our Current Report on Form 8-K filed on
October 19, 2009
|
• |
Our Quarterly Report on Form 10-Q filed on
November 10, 2009
|
The exhibits to the Current Report on Form 8-K and Quarterly Report on Form 10-Q are not included with this prospectus supplement and are not incorporated herein by reference.
Investing in our securities involves a high degree of risk. Before buying any of our securities, you should read the discussion of material risks of investing in our securities in “Risk Factors” beginning on page 6 of the Prospectus, as updated by this prospectus supplement.
You should rely only on the information contained in the Prospectus, any free writing prospectus prepared by us or on our behalf and this prospectus supplement. We have not authorized anyone to provide you with different or additional information. If anyone provides you with different or additional information, you should not rely on it.
Our common stock is listed on the NYSE Amex under the symbol “ANX.” The last reported sale price of our common stock on the NYSE Amex on November 6, 2009 was $0.11 per share. We do not intend to list the convertible preferred stock or warrants on any securities exchange.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of the Prospectus or this prospectus supplement. Any representation to the contrary is a criminal offense.
The date of this prospectus supplement is November 10, 2009.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 16, 2009
ADVENTRX Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware | 001-32157 | 84-1318182 | ||
(State or other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
6725 Mesa Ridge Road, Suite 100 San Diego, CA |
92121 | |
(Address of Principal Executive Offices) | (Zip Code) |
Registrants telephone number, including area code: (858) 552-0866
N/A |
(Former name or former address if changed since last report.) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 5.02. | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers;
Compensatory Arrangements of Certain Officers. |
On October 16, 2009, Alexander J. Denner delivered notice to ADVENTRX Pharmaceuticals, Inc. (the Company) of his resignation, effective immediately, as a director of the Company and from all committees of the Company and its Board of Directors. Dr. Denners resignation was not because of a disagreement with the Company known to any of its executive officers on any matter relating to the Companys operations, policies or practices.
SIGNATURE
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 hereunto duly authorized.
ADVENTRX Pharmaceuticals, Inc.
Dated: October 19, 2009
By: /s/ Patrick L. Keran
Name: Patrick L. Keran
Title: Vice President, Legal
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware | 84-1318182 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
6725 Mesa Ridge Road, Suite 100, San Diego, CA | 92121 | |
(Address of principal executive offices) | (Zip Code) |
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o
(Do not check if a smaller reporting company) |
Smaller reporting company þ |
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2
Item 1. | Financial Statements |
September 30, | December 31, | |||||||
2009 | 2008 | |||||||
(Unaudited) | ||||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 3,159,610 | $ | 9,849,904 | ||||
Interest and other receivables |
39,203 | 121,736 | ||||||
Prepaid expenses |
569,176 | 477,902 | ||||||
Total current assets |
3,767,989 | 10,449,542 | ||||||
Property and equipment, net |
53,608 | 199,052 | ||||||
Other assets |
8,708 | 60,664 | ||||||
Total assets |
$ | 3,830,305 | $ | 10,709,258 | ||||
Liabilities and Stockholders Equity |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 95,598 | $ | 1,721,376 | ||||
Accrued liabilities |
1,981,543 | 2,077,188 | ||||||
Accrued compensation and payroll taxes |
128,381 | 915,459 | ||||||
Total current liabilities |
2,205,522 | 4,714,023 | ||||||
Stockholders equity: |
||||||||
0% Series A Convertible Preferred Stock, $0.001 par value, 1,993 shares
authorized; 1,993 shares issued and 0 shares outstanding as of September 30,
2009 and 0 shares issued and outstanding as of December 31, 2008 |
| | ||||||
5% Series B Convertible Preferred Stock, $0.001 par value, 1,361 shares
authorized; 1,361 shares issued and 0 shares outstanding as of September 30,
2009 and 0 shares issued and outstanding as of December 31, 2008 |
| | ||||||
5% Series C Convertible Preferred Stock, $0.001 par value, 922 shares
authorized; 922 shares issued and 0 shares outstanding as of September 30, 2009
and 0 shares issued and outstanding as of December 31, 2008 |
| | ||||||
Common stock, $0.001 par value; 200,000,000 shares authorized; 124,885,267 and
90,252,572 shares issued and outstanding at September 30, 2009 and December 31,
2008, respectively |
124,886 | 90,254 | ||||||
Additional paid-in capital |
137,059,997 | 131,751,439 | ||||||
Deficit accumulated during the development stage |
(135,560,100 | ) | (125,846,458 | ) | ||||
Total stockholders equity |
1,624,783 | 5,995,235 | ||||||
Total liabilities and stockholders equity |
$ | 3,830,305 | $ | 10,709,258 | ||||
Note: | The balance sheet at December 31, 2008 has been derived from audited financial statements at that date. It does not include, however, all of the information and notes required by accounting principles generally accepted in the United States of America for complete financial statements. |
3
Inception | ||||||||||||||||||||
(June 12, 1996) | ||||||||||||||||||||
Three months ended September 30, | Nine months ended September 30, | through | ||||||||||||||||||
2009 | 2008 | 2009 | 2008 | September 30, 2009 | ||||||||||||||||
Revenues: |
||||||||||||||||||||
Net sales |
$ | | $ | | $ | | $ | | $ | 174,830 | ||||||||||
Cost of goods sold |
| | | | 51,094 | |||||||||||||||
Gross margin |
| | | | 123,736 | |||||||||||||||
Grant revenue |
| | | | 129,733 | |||||||||||||||
Licensing revenue |
| | 300,000 | 500,000 | 1,300,000 | |||||||||||||||
Total revenues |
| | 300,000 | 500,000 | 1,553,469 | |||||||||||||||
Operating expenses: |
||||||||||||||||||||
Research and development |
1,444,038 | 4,741,118 | 4,546,235 | 13,072,820 | 66,560,790 | |||||||||||||||
Selling, general and
administrative |
893,477 | 2,075,092 | 3,744,470 | 7,075,974 | 46,713,673 | |||||||||||||||
Depreciation and amortization |
12,350 | 39,803 | 70,431 | 130,698 | 10,868,502 | |||||||||||||||
In-process research and
development |
| | | | 10,422,130 | |||||||||||||||
Impairment loss write off
of goodwill |
| | | | 5,702,130 | |||||||||||||||
Equity in loss of investee |
| | | | 178,936 | |||||||||||||||
Total operating expenses |
2,349,865 | 6,856,013 | 8,361,136 | 20,279,492 | 140,446,161 | |||||||||||||||
Loss from operations |
(2,349,865 | ) | (6,856,013 | ) | (8,061,136 | ) | (19,779,492 | ) | (138,892,692 | ) | ||||||||||
Loss on fair value of warrants |
| | | | (12,239,688 | ) | ||||||||||||||
Interest and other income
(expense) |
(2,721 | ) | 79,150 | (44,002 | ) | 644,027 | 4,650,405 | |||||||||||||
Interest expense |
| | | | (179,090 | ) | ||||||||||||||
Loss before cumulative effect of
change in accounting principle |
(2,352,586 | ) | (6,776,863 | ) | (8,105,138 | ) | (19,135,465 | ) | (146,661,065 | ) | ||||||||||
Cumulative effect of change
in accounting principle |
| | | | (25,821 | ) | ||||||||||||||
Net loss |
(2,352,586 | ) | (6,776,863 | ) | (8,105,138 | ) | (19,135,465 | ) | (146,686,886 | ) | ||||||||||
Preferred stock dividends |
| | | | (621,240 | ) | ||||||||||||||
Deemed dividends on preferred
stock |
(376,089 | ) | | (1,608,504 | ) | | (1,608,504 | ) | ||||||||||||
Net loss applicable to common
stock |
$ | (2,728,675 | ) | $ | (6,776,863 | ) | $ | (9,713,642 | ) | $ | (19,135,465 | ) | $ | (148,916,630 | ) | |||||
Net loss per common share
basic and diluted |
$ | (0.02 | ) | $ | (0.08 | ) | $ | (0.10 | ) | $ | (0.21 | ) | ||||||||
Weighted average shares basic
and diluted |
119,480,719 | 90,252,572 | 101,159,417 | 90,252,572 | ||||||||||||||||
4
Inception | ||||||||||||
(June 12, 1996) | ||||||||||||
through | ||||||||||||
Nine months ended September 30, | September 30, | |||||||||||
2009 | 2008 | 2009 | ||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (8,105,138 | ) | $ | (19,135,465 | ) | $ | (146,686,887 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
Depreciation and amortization |
70,431 | 130,698 | 10,418,502 | |||||||||
Loss on disposal of fixed assets |
59,012 | | 55,414 | |||||||||
Fair value of warrant liability |
| | 12,239,688 | |||||||||
In-process research and development |
| | 10,422,130 | |||||||||
Share-based compensation for employee awards |
454,827 | 1,356,393 | 8,307,389 | |||||||||
Expense related to stock options issued to non-employees |
| 5,513 | 204,664 | |||||||||
Expenses paid by issuance of common stock |
| | 1,341,372 | |||||||||
Expenses paid by issuance of warrants |
| | 573,357 | |||||||||
Expenses paid by issuance of preferred stock |
| | 142,501 | |||||||||
Expenses related to stock warrants issued |
| | 612,000 | |||||||||
Accretion of discount on investments in securities |
| (208,103 | ) | (1,604,494 | ) | |||||||
Amortization of debt discount |
| | 450,000 | |||||||||
Forgiveness of employee receivable |
| | 30,036 | |||||||||
Impairment loss write-off of goodwill |
| | 5,702,130 | |||||||||
Equity in loss of investee |
| | 178,936 | |||||||||
Write-off of license agreement |
| | 152,866 | |||||||||
Write-off of assets available-for-sale |
| | 108,000 | |||||||||
Cumulative effect of change in accounting principle |
| | 25,821 | |||||||||
Changes in assets and liabilities, net of effect of acquisitions: |
||||||||||||
(Increase) decrease in prepaid expenses and other assets |
43,215 | (945,949 | ) | (864,456 | ) | |||||||
Increase (decrease) in accounts payable and accrued liabilities |
(2,508,501 | ) | 517,882 | 2,382,230 | ||||||||
Decrease in other long-term liabilities |
| (14,270 | ) | | ||||||||
Net cash used in operating activities |
(9,986,154 | ) | (18,293,301 | ) | (95,808,801 | ) | ||||||
Cash flows from investing activities: |
||||||||||||
Purchases of short-term investments |
| (14,355,784 | ) | (111,183,884 | ) | |||||||
Proceeds from sales and maturities of short-term investments |
| 33,243,602 | 112,788,378 | |||||||||
Purchases of property and equipment |
| (68,780 | ) | (1,030,354 | ) | |||||||
Proceeds from sale of property and equipment |
16,000 | | 49,906 | |||||||||
Purchase of certificate of deposit |
| | (1,016,330 | ) | ||||||||
Maturity of certificate of deposit |
| | 1,016,330 | |||||||||
Payment on obligation under license agreement |
| | (106,250 | ) | ||||||||
Cash acquired from acquisitions, net of cash paid |
| | 32,395 | |||||||||
Issuance of note receivable related party |
| | (35,000 | ) | ||||||||
Payments on note receivable |
| | 405,993 | |||||||||
Advance to investee |
| | (90,475 | ) | ||||||||
Cash transferred in rescission of acquisition |
| | (19,475 | ) | ||||||||
Cash received in rescission of acquisition |
| | 230,000 | |||||||||
Net cash provided by investing activities |
16,000 | 18,819,038 | 1,041,234 | |||||||||
Cash flows from financing activities: |
||||||||||||
Proceeds from sale of preferred stock |
4,276,000 | | 8,476,993 | |||||||||
Proceeds from sale of common stock |
| | 84,151,342 | |||||||||
Proceeds from exercise of stock options |
| | 712,367 | |||||||||
Proceeds from sale or exercise of warrants |
| | 11,382,894 | |||||||||
Repurchase of warrants |
| | (55,279 | ) | ||||||||
Payment of financing and offering costs |
(996,140 | ) | | (7,479,949 | ) | |||||||
Payments of notes payable and long-term debt |
| | (605,909 | ) | ||||||||
Proceeds from issuance of notes payable and detachable warrants |
| | 1,344,718 | |||||||||
Net cash provided by financing activities |
3,279,860 | | 97,927,177 | |||||||||
Net increase (decrease) in cash and cash equivalents |
(6,690,294 | ) | 525,737 | 3,159,610 | ||||||||
Cash and cash equivalents at beginning of period |
9,849,904 | 14,780,739 | | |||||||||
Cash and cash equivalents at end of period |
$ | 3,159,610 | $ | 15,306,476 | $ | 3,159,610 | ||||||
5
1. | Basis of Presentation | |
ADVENTRX Pharmaceuticals, Inc., a Delaware corporation (ADVENTRX, we, our or the Company), prepared the unaudited interim condensed consolidated financial statements included in this report in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) for interim financial information and with the instructions of the Securities and Exchange Commission (SEC). Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for annual audited financial statements and should be read in conjunction with our audited consolidated financial statements and related notes for the year ended December 31, 2008 included in our Annual Report on Form 10-K filed with the SEC on March 27, 2009 (2008 Annual Report). The condensed consolidated balance sheet as of December 31, 2008 included in this report has been derived from the audited consolidated financial statements included in the 2008 Annual Report. In the opinion of management, these consolidated financial statements include all adjustments (consisting of normal recurring adjustments) necessary for a fair presentation of the financial position, results of operations, and cash flows for the periods presented. The results of operations for the interim periods shown in this report are not necessarily indicative of results expected for the full year. | ||
The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, SD Pharmaceuticals, Inc. and ADVENTRX (Europe) Ltd. All intercompany accounts and transactions have been eliminated in consolidation. |
2. | Going Concern | |
At the time that we prepared our consolidated financial statements for the period ended and at December 31, 2008, there was substantial doubt about our ability to continue as a going concern. The report of our independent registered public accounting firm, dated March 25, 2009 and included in our Annual Report on Form 10-K that we filed with the U.S. Securities and Exchange Commission on March 27, 2009, included a going concern qualification. Our independent registered public accounting firm indicated that we had suffered recurring losses from operations and negative cash flows from operations that raised substantial doubt about our ability to continue as a going concern. | ||
On June 12, 2009, July 6, 2009 and August 10, 2009, we completed registered direct equity financings with proceeds, net of dividend payments and offering costs, of approximately $1.7 million, $0.8 million and $0.7 million, respectively. On October 9, 2009, we completed a fourth registered direct equity financing with proceeds, net of dividends and estimated offering costs, of approximately $5.1 million. We may receive up to $2.9 million of additional proceeds from the exercise of warrants issued in that financing. The warrants have an exercise price of $0.1468 per share; however, the exercise of those warrants is subject to certain beneficial ownership limitations. | ||
We anticipate that our cash and cash equivalents as of September 30, 2009, together with the net proceeds from the registered direct equity financing we completed on October 9, 2009, will be sufficient to permit us to continue operations through 2010. However, we may pursue development activities at levels or on timelines, or we may incur unexpected expenses, that shorten the period through which our operating funds will sustain us. In addition, we will need substantial additional funds to commercialize our lead product candidate, ANX-530, in the United States, if a new drug application (NDA) for that product is submitted and approved by the U.S. Food & Drug Administration (FDA), including acquiring or developing sales, marketing and distribution capabilities and the associated regulatory compliance infrastructure, and to continue the development of our other lead product candidate, ANX-514. There can be no assurances that we will be able to raise additional capital in the future on a timely basis, or at all. | ||
The accompanying unaudited interim condensed consolidated financial statements for the nine months ended September 30, 2009 have been prepared assuming we will continue as a going concern. This basis of accounting contemplates the recovery of our assets and the satisfaction of liabilities in the normal course of business and does not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern. |
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3. | Use of Estimates | |
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. |
4. | Fair Value | |
At September 30, 2009, our financial instruments included cash and cash equivalents, accounts payable, accrued expenses and accrued compensation and payroll taxes. The carrying amounts of cash and cash equivalents, accounts payable, accrued expenses and accrued compensation and payroll taxes approximate fair value due to the short-term maturities of these instruments. | ||
We have fully adopted the provisions of the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 820, Fair Value Measurements and Disclosures. The adoption of ASC 820 did not have a material impact on our consolidated results of operations or financial condition. | ||
ASC 820 defines fair value, establishes a framework for measuring fair value under U.S. GAAP and enhances disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. ASC 820 describes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following: |
| Level 1 | | Quoted prices in active markets for identical assets or liabilities. | |||||
| Level 2 | | Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. | |||||
| Level 3 | | Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
5. | Share-Based Compensation Expense | |
Estimated share-based compensation expense related to equity awards granted to employees, including our non-employee directors, for the three and nine months ended September 30, 2009 and 2008 was as follows: |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
Selling, general and administrative expense |
$ | 135,343 | $ | 163,853 | $ | 424,095 | $ | 712,627 | ||||||||
Research and development expense |
14,305 | 198,282 | 30,731 | 643,766 | ||||||||||||
Share-based compensation expense before taxes |
149,648 | 362,135 | 454,826 | 1,356,393 | ||||||||||||
Related income tax benefits |
| | | | ||||||||||||
Share-based compensation expense |
$ | 149,648 | $ | 362,135 | $ | 454,826 | $ | 1,356,393 | ||||||||
Net share-based compensation expense per common
share basic and diluted |
$ | 0.00 | $ | 0.00 | $ | 0.00 | $ | 0.02 | ||||||||
In January 2009, we granted restricted stock units under our 2008 Omnibus Incentive Plan to seven employees that represented the right to receive in the aggregate 3,700,000 shares of our common stock. These units were to vest immediately prior to a strategic transaction (as defined in the documentation evidencing the grant of the units). We would record share-based compensation expense in connection with these restricted stock units, if at all, only if a strategic transaction was consummated. As of June 30, 2009, as a result of employee terminations and resignations, there were outstanding restricted stock units representing the right to |
7
receive an aggregate of 3,150,000 shares of our common stock. In July 2009, as a result of an employee resignation and the termination of a consulting relationship with a former employee, restricted stock units representing the right to receive an aggregate of 1,100,000 shares of our common stock were canceled and, in connection with certain compensation arrangements with our remaining two employees, we terminated restricted stock units representing the right to receive an aggregate of 2,050,000 shares of our common stock. As of September 30, 2009, we did not have outstanding any restricted stock units. |
Since we have net operating loss carryforwards as of September 30, 2009, no excess tax benefits for the tax deductions related to share-based awards were recognized in the accompanying condensed consolidated statements of operations. There were no employee stock options exercised during the nine months ended September 30, 2009 and 2008. |
At September 30, 2009, total unrecognized estimated compensation cost related to non-vested employee and non-employee director share-based awards granted prior to that date was $1.2 million, which is expected to be recognized over a weighted-average period of 2.7 years. During the three and nine months ended September 30, 2009, we granted stock options to acquire 3,400,000 shares of our common stock to our employees with an estimated weighted-average grant-date fair value of $0.127 per share. During the three and nine months ended September 30, 2008, we granted stock options to acquire 228,000 and 2,880,500 shares of our common stock, respectively, to our employees and non-employee directors with an estimated weighted-average grant-date fair value of $0.18 and $0.46 per share, respectively. |
Estimated share-based compensation expense related to equity awards granted to non-employee consultants was $0 for the three months ended September 30, 2009 and 2008; and $0 and $6,000 for the nine months ended September 30, 2009 and 2008, respectively. |
6. | Comprehensive Loss |
Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources, including foreign currency translation adjustments and unrealized gains and losses on short-term investments. Our components of comprehensive loss consist of net loss and unrealized gains or losses on short-term investments in securities. For the three months ended September 30, 2009 and 2008, comprehensive loss was $2.4 million and $6.8 million, respectively. For the nine months ended September 30, 2009 and 2008, comprehensive loss was $8.1 million and $19.1 million, respectively. |
7. | Net Loss Per Common Share |
Basic and diluted net loss per common share was calculated by dividing the net loss applicable to common stock for the period by the weighted-average number of common shares outstanding during the period, without consideration for common stock equivalents. Options and warrants are considered to be common stock equivalents and are only included in the calculation of diluted earnings per common share when their effect is dilutive. Because of the net loss, all of the options and warrants were excluded from the calculation. |
We have excluded the following options and warrants from the calculation of diluted net loss per common share for the three and nine months ended September 30, 2009 and 2008 because they are anti-dilutive, due to the net loss: |
2009 | 2008 | |||||||
Warrants |
20,658,733 | 13,373,549 | ||||||
Options |
5,859,000 | 6,089,149 | ||||||
26,517,733 | 19,462,698 | |||||||
8. | Recent Accounting Pronouncements | |
In June 2009, the FASB issued ASC 105, Generally Accepted Accounting Principles, which establishes the FASB ASC as the sole source of authoritative U.S. GAAP other than guidance issued by the Securities Exchange Commission (SEC). Pursuant to the provisions of ASC 105, the Company has updated references to U.S. GAAP in its financial statements issued for the period ended September 30, 2009. The adoption of ASC 105 had no impact on our consolidated results of operations, financial position or cash flows. |
8
In May 2009, the FASB issued ASC 855, Subsequent Events, which established general standards of accounting for and disclosure of events that occur after the balance sheet date but before the financial statements are issued or available to be issued. ASC 855 requires new disclosure in financial statements by providing the date through which reporting entities have evaluated events or transactions that occur after the balance sheet date but before the financial statements are issued or available to be issued. ASC 855 requires public entities, including the Company, to evaluate subsequent events through the date that the financial statements are issued. Financial statements are considered issued when they are widely distributed to stockholders and other financial statement users for general use and reliance in a form and format that complies with U.S. GAAP. ASC 855 was effective for our financial statements issued for the period ended June 30, 2009. The adoption of ASC 855 had no impact on our consolidated results of operations, financial position or cash flows. |
9. | Licensing Revenue | |
In March 2009, we announced that we and our wholly-owned subsidiary, SD Pharmaceuticals, Inc., had entered into a license agreement with respect to our product candidate ANX-514 (docetaxel emulsion) (the License Agreement) with Shin Poong Pharmaceutical Co., Ltd., a company organized under the laws of the Republic of Korea (Shin Poong), pursuant to which we granted to Shin Poong an exclusive license, including the right to sublicense, to research, develop, make, have made, use, offer for sale, sell and import licensed products, in each case solely for the treatment of cancer by intravenous administration of formulations of docetaxel as emulsified products and solely in South Korea. Under the terms of the License Agreement, we would receive an upfront licensing fee of $0.3 million, a regulatory milestone payment of either $0.2 million or $0.4 million upon receipt of regulatory approval for marketing a licensed product in South Korea (the amount depends on whether the Korea Food and Drug Administration requires Shin Poong to conduct a bioequivalence or clinical study in human subjects prior to receipt of regulatory approval), one-time commercial milestone payments tied to annual net sales of licensed products in an aggregate amount of up to $1.5 million and royalty payments on net sales of licensed products. Shin Poong is responsible for all development and commercial activities related to ANX-514 in South Korea. If the Korea Food and Drug Administration requires Shin Poong to conduct a bioequivalence or clinical trial in human subjects prior to receipt of regulatory approval and we elect not to supply product to conduct such trial, which supply obligation is subject to limitations, we will pay Shin Poong $0.1 million. | ||
We received the $0.3 million upfront licensing fee in April 2009. We recognized $0.3 million in licensing revenue in the three-month period ended March 31, 2009 because we met the criteria under our revenue recognition policy in that period. We recorded a liability of $0.1 million, less amounts paid for the benefit of Shin Poong, in the three-month period ended June 30, 2009, but not in the three-month period ended March 31, 2009, because our obligation to Shin Poong was not probable in the three-month period ended March 31, 2009 but became so in the three-month period ended June 30, 2009. |
10. | Supplementary Cash Flow Information | |
Noncash investing and financing transactions excluded from the condensed consolidated statements of cash flows for the nine months ended September 30, 2009 and 2008 and for the period from inception (June 12, 1996) through September 30, 2009 are as follows: |
Inception | ||||||||||||
(June 12, 1996) | ||||||||||||
Nine months ended September 30, | through | |||||||||||
2009 | 2008 | September 30, 2009 | ||||||||||
Supplemental disclosures of cash flow information: |
||||||||||||
Interest paid |
$ | | $ | | $ | 179,090 | ||||||
Income taxes paid |
| | | |||||||||
Issuance of warrants, common stock and preferred stock for: |
||||||||||||
Conversion of notes payable and accrued interest |
| | 1,213,988 | |||||||||
Prepaid services to consultants |
| | 1,482,781 | |||||||||
Conversion of preferred stock |
34,632 | | 37,337 | |||||||||
Acquisitions |
| | 24,781,555 | |||||||||
Payment of dividends |
| | 213,000 | |||||||||
Financial advisor services in connection with private placements |
240,012 | | 1,377,468 | |||||||||
Acquisition of treasury stock in settlement of a claim |
| | 34,747 | |||||||||
Cancellation of treasury stock |
| | (34,747 | ) | ||||||||
Assumptions of liabilities in acquisitions |
| | 1,235,907 | |||||||||
Acquisition of license agreement for long-term debt |
| | 161,180 | |||||||||
Cashless exercise of warrants |
| | 4,312 | |||||||||
Dividends accrued |
| | 621,040 | |||||||||
Trade asset converted to available-for-sale asset |
| | 108,000 | |||||||||
Dividends extinguished |
| | 408,240 | |||||||||
Trade payable converted to note payable |
| | 83,948 | |||||||||
Issuance of warrants for return of common stock |
| | 50,852 | |||||||||
Detachable warrants issued with notes payable |
| | 450,000 | |||||||||
Purchases of equipment, which are included in accounts payable |
| 3,825 | | |||||||||
Unrealized (gain) loss on short-term investments |
| 2,702 | | |||||||||
Cumulative preferred stock dividends |
455,500 | | 455,500 |
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11. | Severance Related Expenses | |
In January 2009, as part of a restructuring to reduce operating costs, we completed a workforce reduction of six employees. As a result of the that workforce reduction, we recorded severance related charges of $174,000, of which $86,000 was recorded in research and development and the balance of which was recorded in selling, general and administrative. We recorded $144,000 of such severance related charges in the first quarter of 2009 and the balance was recorded in the second quarter of 2009. As of June 30, 2009, all severance related costs related to the January 2009 workforce reduction had been paid. | ||
On April 3, 2009, we completed a workforce reduction of nine employees. As a result of that workforce reduction, we recorded severance related charges of $160,000, of which $101,000 was recorded in research and development and the balance of which was recorded in selling, general and administrative. We recorded $114,000 of such severance related charges in the first quarter of 2009 and the balance was recorded in the second quarter of 2009. As of June 30, 2009, all severance related costs related to the April 2009 workforce reduction had been paid. |
12. | Equity Transactions | |
0% Series A Convertible Preferred Stock. | ||
In June 2009, we completed a registered direct equity financing raising gross proceeds of approximately $2.0 million involving the issuance of 1,993 shares of our 0% Series A Convertible Preferred Stock with a stated value of $1,000 per share (Series A Stock), and 5-year warrants to purchase up to 8,116,290 shares of our common stock. In the aggregate, the shares of our Series A Stock we issued are convertible into 18,036,199 shares of our common stock. We received approximately $1.7 million in net proceeds from the financing, after deducting the placement agents fees and other offering expenses. We may receive up to approximately $1.2 million of additional proceeds from the exercise of the warrants issued in the financing. Those warrants, which have an exercise price of $0.15 per share, are exercisable any time after the six-month anniversary of their issuance date through the five-year anniversary of the date they were first exercisable, subject to certain beneficial ownership limitations. All of the shares of the Series A Stock issued in the financing have been converted into common stock and are outstanding. | ||
The convertible feature of our Series A Stock and the terms of the warrants issued in connection with our Series A Stock provide for a rate of conversion or exercise that was below the market value of our common stock at issuance. The convertible feature of our Series A Stock is characterized as a beneficial conversion feature (BCF). The estimated relative fair values of the shares of our Series A Stock and the warrants issued in connection with such stock were calculated as approximately $1.2 million and $531,000, respectively. The value of the BCF was determined using the intrinsic value method and calculated as approximately $1.2 million. Because our Series A Stock did not have a stated redemption date, the value of the BCF was fully realized at the time our Series A Stock was issued. The fair value of the warrants was determined using the Black-Scholes option-pricing model at the date of issuance assuming a five-year term, stock volatility of 197.01%, and a risk-free interest rate of 2.81%. The value of the BCF is treated as a deemed dividend to the holders of our Series A Stock and, due to the potential immediate convertibility of our Series A Stock at issuance, was recorded as an increase to additional paid-in capital and accumulated deficit at the time of issuance. | ||
We also issued warrants to purchase up to 901,810 shares of our common stock at an exercise price of $0.15 per share to the placement agent in the financing as additional consideration for its services in connection with the financing. These warrants had a fair value of approximately $132,000 using the Black-Scholes option-pricing model. The warrants are exercisable at any time after the six-month anniversary of their date of issuance and on or before the fifth anniversary of their issuance date. |
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5% Series B Convertible Preferred Stock. |
In July 2009, we completed a registered direct equity financing raising gross proceeds of approximately $1.4 million involving the issuance of 1,361 shares of our 5% Series B Convertible Preferred Stock with a stated value of $1,000 per share (Series B Stock). In the aggregate, the shares of our Series B Stock we issued are convertible into 9,504,189 shares of our common stock. Our Series B Stock accrues a cumulative annual dividend of 5% per share until July 6, 2014, and no dividend thereafter. If our Series B Stock is converted at any time prior to July 6, 2014, we will pay the holder an amount equal to the total dividend that would have accrued in respect of the shares converted from the conversion date through July 6, 2014, or $250 per $1,000 of stated value of the shares converted, less any previous dividend paid on such shares before conversion. We received approximately $0.8 million in net proceeds from the financing after deducting the $340,250 we placed into an escrow account to pay the dividend payment in respect of our Series B Stock, placement agents fees and other offering expenses. All of the shares of our Series B Stock issued in the financing have been converted into common stock and are outstanding. |
The convertible feature of our Series B Stock and the value of the dividend in respect thereof provide for a rate of conversion that was below the market value of our common stock at issuance. The convertible feature of our Series B Stock is characterized as a BCF. The estimated relative fair value of the shares of our Series B Stock was calculated as approximately $1.0 million. The value of the BCF was determined using the intrinsic value method and calculated as approximately $215,000. Because our Series B Stock does not have a stated redemption date, the value of the BCF was fully realized at the time our Series B Stock was issued. The value of the BCF is treated as a deemed dividend to the holders of our Series B Stock and, due to the potential immediate convertibility of our Series B Stock at issuance, was recorded as an increase to additional paid-in capital and accumulated deficit at the time of issuance. |
We also issued warrants to purchase up to 475,209 shares of our common stock at an exercise price of $0.179 per share to the placement agent in the financing as additional consideration for its services in connection with the financing. These warrants had a fair value of approximately $60,000 using the Black-Scholes option-pricing model at the date of issuance. The warrants are exercisable at any time after the six-month anniversary of their date of issuance and on or before the fifth anniversary of their issuance date. |
5% Series C Convertible Preferred Stock. |
In August 2009, we completed a registered direct equity financing raising gross proceeds of approximately $0.9 million involving the issuance of 922 shares of our 5% Series C Convertible Preferred Stock with a stated value of $1,000 per share (Series C Stock). In the aggregate, the shares of our Series C Stock we issued are convertible into 7,092,307 shares of our common stock. Our Series C Stock accrues a cumulative annual dividend of 5% per share until February 10, 2012, and no dividend thereafter. If our Series C Stock is converted at any time prior to February 10, 2012, we will pay the holder an amount equal to the total dividend that would have accrued in respect of the shares converted from the conversion date through February 10, 2012, or $125 per $1,000 of stated value of the shares converted, less any previous dividend paid on such shares before conversion. We received approximately $0.7 million in net proceeds from the financing after deducting the $115,250 we placed into an escrow account to pay the dividend payment in respect of our Series C Stock, placement agents fees and other offering expenses. All of the shares of our Series C Stock issued in the financing have been converted into common stock and are outstanding. |
The convertible feature of our Series C Stock and the value of the dividend in respect thereof provide for a rate of conversion that was below the market value of our common stock at issuance. The convertible feature of our Series C Stock is characterized as a BCF. The estimated relative fair value of the shares of our Series C Stock was calculated as approximately $807,000. The value of the BCF was determined using the intrinsic value method and calculated as approximately $186,000. Because our Series C Stock does not have a stated redemption date, the value of the BCF was fully realized at the time our Series C Stock was issued. The value of the BCF is treated as a deemed dividend to the holders of our Series C Stock and, due to the potential immediate convertibility of our Series C Stock at issuance, was recorded as an increase to additional paid-in capital and accumulated deficit at the time of issuance. |
We also issued warrants to purchase up to 354,615 shares of our common stock at an exercise price of $0.1625 per share to the placement agent in the financing as additional consideration for its services in connection with the financing. These warrants had a fair value of approximately $48,000 using the Black-Scholes option-pricing model at the date of issuance. The warrants are exercisable at any time after the six-month anniversary of their date of issuance and on or before the fifth anniversary of their issuance date. |
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13. | Subsequent Events |
In accordance with ASC 855, we have evaluated subsequent events through the date and time the financial statements were issued on November 10, 2009. |
Authorized Share Increase. |
On October 5, 2009, we filed a Certificate of Amendment to our Amended and Restated Certificate of Incorporation of the Company to increase the authorized shares of our common stock from 200,000,000 to 500,000,000. |
4.25660% Series D Convertible Preferred Stock. |
On October 9, 2009, we completed a registered direct equity financing raising gross proceeds of approximately $11.3 million involving the issuance of 11,283 shares of our 4.25660% Series D Convertible Preferred Stock with a stated value of $1,000 per share (Series D Stock), and 5-year warrants to purchase up to 19,800,000 shares of our common stock. In the aggregate, the shares of our Series D Stock we issued are convertible into 60,000,000 shares of our common stock. Our Series D Stock accrues a cumulative annual dividend of 4.25660% per share until October 9, 2020, and no dividend thereafter. If our Series D Stock is converted at any time prior to October 9, 2020, we will pay the holder an amount equal to the total dividend that would have accrued in respect of the shares converted from the conversion date through October 9, 2020, or $468.23 per $1,000 of stated value of the shares converted, less any previous dividend paid on such shares before conversion. We received approximately $5.1 million in net proceeds from the financing after deducting the approximately $5.3 million we placed into an escrow account to pay the dividend payment in respect of our Series D Stock, placement agents fees and other estimated offering expenses. We may receive up to approximately $2.9 million of additional proceeds from the exercise of the warrants issued in the financing. Those warrants, which have an exercise price of $0.1468 per share, are exercisable any time through the five-year anniversary of their issuance date, subject to certain beneficial ownership limitations. We also issued warrants to purchase up to 3,600,000 shares of our common stock at an exercise price of $0.235 per share to the placement agent in the financing as additional consideration for its services in connection with the financing. The warrants are exercisable at any time after the six-month anniversary of the effective date of the registration statement that registered our Series D Stock and on or before the fifth anniversary of such date. Upon conversion of our Series D Stock to common stock, we will have approximately 185 million shares of common stock outstanding. |
The convertible feature of our Series D Stock and the terms of the warrants issued in connection with our Series D Stock provide for a rate of conversion or exercise that was below the market value of our common stock at issuance. The convertible feature of our Series D Stock is characterized as BCF. The estimated relative fair values of the shares of our Series D Stock and the warrants issued in connection with such stock were calculated as approximately $3.9 million and $1.3 million, respectively. The value of the BCF was determined using the intrinsic value method and calculated as approximately $3.3 million. Because our Series D Stock did not have a stated redemption date, the value of the BCF was fully realized at the time our Series D Stock was issued. The fair value of the warrants was determined using the Black-Scholes option-pricing model at the date of issuance assuming a five-year term, stock volatility of 197.63%, and a risk-free interest rate of 2.36%. The value of the BCF is treated as a deemed dividend to the holders of our Series D Stock and, due to the potential immediate convertibility of our Series D Stock at issuance, was recorded as an increase to additional paid-in capital and accumulated deficit at the time of issuance. |
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Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations |
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14
15
16
| the number and location of sites included in trials and the rate of site approval for the trial; | ||
| the rates of patient recruitment and enrollment; | ||
| the ratio of randomized to evaluable patients; | ||
| the availability and cost of reference product in the jurisdiction of each site; | ||
| the time and cost of process development activities related to our product candidates; | ||
| the costs of manufacturing our product candidates; and | ||
| the costs, requirements, timing of and the ability to secure regulatory approvals. |
17
January 1, 2005 | ||||||||||||||||||||
Three months ended September 30, | through | |||||||||||||||||||
2009 | 2008 | $ Variance | % Variance | September 30, 2009 | ||||||||||||||||
External clinical study fees and expenses |
$ | 28,583 | $ | 737,644 | $ | (709,061 | ) | (96 | %) | $ | 23,762,912 | |||||||||
External non-clinical study fees and
expenses (1) |
1,372,543 | 3,105,617 | (1,733,074 | ) | (56 | %) | 22,113,626 | |||||||||||||
Personnel costs |
28,607 | 699,575 | (670,968 | ) | (96 | %) | 10,295,106 | |||||||||||||
Share-based compensation expense |
14,305 | 198,282 | (183,977 | ) | (93 | %) | 2,914,892 | |||||||||||||
Total |
$ | 1,444,038 | $ | 4,741,118 | $ | (3,297,080 | ) | (70 | %) | $ | 59,086,536 | |||||||||
(1) | External non-clinical study fees and expenses include preclinical, research-related manufacturing, quality assurance and regulatory expenses. |
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January 1, 2005 | ||||||||||||||||||||
Nine months ended September 30, | through | |||||||||||||||||||
2009 | 2008 | $ Variance | % Variance | September 30, 2009 | ||||||||||||||||
External clinical study fees and expenses |
$ | 563,433 | $ | 2,711,909 | $ | (2,148,476 | ) | (79 | %) | $ | 24,297,762 | |||||||||
External non-clinical study fees and
expenses (1) |
3,168,153 | 7,176,135 | (4,007,982 | ) | (56 | %) | 23,909,236 | |||||||||||||
Personnel costs |
783,918 | 2,541,010 | (1,757,092 | ) | (69 | %) | 11,050,417 | |||||||||||||
Share-based compensation expense |
30,731 | 643,766 | (613,035 | ) | (95 | %) | 2,931,318 | |||||||||||||
Total |
$ | 4,546,235 | $ | 13,072,820 | $ | (8,526,585 | ) | (65 | %) | $ | 62,188,733 | |||||||||
(1) | External non-clinical study fees and expenses include preclinical, research-related manufacturing, quality assurance and regulatory expenses. |
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Item 3. | Quantitative and Qualitative Disclosures About Market Risk |
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Item 4T. | Controls and Procedures |
Item 1. | Legal Proceedings |
Item 1A. | Risk Factors |
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
Item 3. | Defaults Upon Senior Securities |
Item 4. | Submission of Matters to a Vote of Security Holders |
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Votes For | Votes Against | Votes Abstained | ||
58,564,236
|
20,208,994 | 655,889 |
Votes For | Votes Against | Votes Abstained | ||
60,810,956 | 17,914,315 | 703,846 |
Item 5. | Other Information |
Item 6. | Exhibits |
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ADVENTRX Pharmaceuticals, Inc. |
||||
Date: November 10, 2009 | By: | /s/ Brian M. Culley | ||
Brian M. Culley | ||||
Chief Business Officer and Senior Vice President (Duly Authorized Officer) | ||||
By: | /s/ Patrick L. Keran | |||
Patrick L. Keran | ||||
General Counsel, Secretary and Vice President, Legal (Principal Financial and Principal Accounting Officer) |
24
Exhibit | Description | |
3.1(1)
|
Certificate of Designation of Preferences, Rights and Limitation of 5% Series C Convertible Preferred Stock dated August 5, 2009 | |
3.2(2)
|
Certificate of Designation of Preferences, Rights and Limitation of 4.25660% Series D Convertible Preferred Stock dated October 5, 2009 | |
3.3(3)
|
Amended and Restated Certificate of Incorporation dated October 5, 2009 | |
10.1#(4)
|
Form of Incentive Stock Option Grant Agreement for use in connection with the July 2009 option grant to Brian M. Culley | |
10.2#(4)
|
Form of Incentive Stock Option Grant Agreement for use in connection with the July 2009 option grant to Patrick L. Keran | |
10.3#(4)
|
2009 Mid-Year Incentive Plan | |
10.4#(4)
|
Retention and Severance Plan (as of July 21, 2009) | |
10.5(5)
|
Second Amendment to Standard Multi-Tenant Office Lease Gross, dated July 22, 2009, by and among Westcore Mesa View, LLC, DD Mesa View LLC and ADVENTRX Pharmaceuticals, Inc. | |
10.6(6)
|
Consulting Agreement with Mark N.K. Bagnall dated August 24, 2009 | |
10.7(7)
|
Third Amendment to Rights Agreement, dated August 26, 2009, among the registrant and the Icahn Purchasers (as defined therein) | |
10.8(8)
|
Form of Common Stock Purchase Warrant issued on July 6, 2009 to Rodman & Renshaw, LLC | |
10.9(1)
|
Engagement Letter Agreement, dated August 4, 2009, by and between ADVENTRX Pharmaceuticals, Inc. and Rodman & Renshaw, LLC | |
10.10(1)
|
Securities Purchase Agreement, dated August 5, 2009, by and between ADVENTRX Pharmaceuticals, Inc. and the purchasers listed on the signature pages thereto | |
10.11(1)
|
Form of Common Stock Purchase Warrant issued on August 10, 2009 to Rodman & Renshaw, LLC | |
10.12(2)
|
Engagement Letter Agreement, dated September 24, 2009, by and between ADVENTRX Pharmaceuticals, Inc. and Rodman & Renshaw, LLC | |
10.13(2)
|
Form of Securities Purchase Agreement dated October 6, 2009 | |
10.14(2)
|
Form of Common Stock Purchase Warrant issued October 6, 2009 (2) | |
31.1
|
Certification of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a) | |
31.2
|
Certification of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a) | |
32.1*
|
Certification of principal executive officer and principal financial officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
* | This certification is being furnished solely to accompany this report pursuant to 18 U.S.C. 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing. | |
# | Management contract or compensation plan or arrangement | |
(1) | Incorporated by reference to the registrants Current Report on Form 8-K filed August 5, 2009 | |
(2) | Incorporated by reference to the registrants Amendment No. 3 to Form S-1 filed October 5, 2009 | |
(3) | Incorporated by reference to the registrants Current Report on Form 8-K filed October 13, 2009 | |
(4) | Incorporated by reference to the registrants Current Report on Form 8-K filed July 21, 2009 | |
(5) | Incorporated by reference to the registrants Current Report on Form 8-K filed August 19, 2009 | |
(6) | Incorporated by reference to the registrants Current Report on Form 8-K filed August 24, 2009 | |
(7) | Incorporated by reference to the registrants Current Report on Form 8-K filed September 1, 2009 | |
(8) | Incorporated by reference to the registrants Current Report on Form 8-K filed June 30, 2009 |
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