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Filing
Table of Contents
FORM 10-Q
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2007
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Transition Period from to
Commission File Number 001-32157
ADVENTRX Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware | 84-1318182 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
6725 Mesa Ridge Road, Ste 100, San Diego, CA | 92121 | |
(Address of principal executive offices) | (Zip Code) |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
The number of shares outstanding of the registrants common stock, $.001 par value, as of May 4,
2007 was 89,706,739.
Table of Contents
TABLE OF CONTENTS
Page | ||||||||
PART I | ||||||||
Item 1. | ||||||||
3 | ||||||||
4 | ||||||||
5 | ||||||||
6 | ||||||||
Item 2. | 12 | |||||||
Item 3. | 17 | |||||||
Item 4. | 17 | |||||||
PART II | ||||||||
Item 1. | 18 | |||||||
Item 1A. | 18 | |||||||
Item 2. | 18 | |||||||
Item 3. | 18 | |||||||
Item 4. | 18 | |||||||
Item 5. | 18 | |||||||
Item 6. | 18 | |||||||
19 | ||||||||
EXHIBIT 10.1 | ||||||||
EXHIBIT 10.2 | ||||||||
EXHIBIT 10.3 | ||||||||
EXHIBIT 31.1 | ||||||||
EXHIBIT 31.2 | ||||||||
EXHIBIT 32.1 |
2
Table of Contents
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
ADVENTRX Pharmaceuticals, Inc. and Subsidiaries
(A Development Stage Enterprise)
(A Development Stage Enterprise)
Condensed Consolidated Balance Sheets
March 31, | December 31, | |||||||
2007 | 2006 | |||||||
(unaudited) | (Note 1) | |||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 20,954,573 | $ | 25,974,041 | ||||
Short-term investments |
26,485,512 | 25,771,406 | ||||||
Interest receivable |
131,524 | 80,338 | ||||||
Prepaid expenses |
612,286 | 511,327 | ||||||
Total current assets |
48,183,895 | 52,337,112 | ||||||
Property and equipment, net |
387,509 | 402,968 | ||||||
Other assets |
58,305 | 58,305 | ||||||
Total assets |
$ | 48,629,709 | $ | 52,798,385 | ||||
Liabilities and Stockholders Equity |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 98,596 | $ | 480,402 | ||||
Accrued liabilities |
1,906,948 | 1,675,226 | ||||||
Accrued compensation and payroll taxes |
777,664 | 292,896 | ||||||
Total current liabilities |
2,783,208 | 2,448,524 | ||||||
Long-term liabilities |
30,323 | 35,674 | ||||||
Total liabilities |
2,813,531 | 2,484,198 | ||||||
Commitments and contingencies |
||||||||
Stockholders equity: |
||||||||
Preferred stock; 1,000,000 shares authorized; no shares issued or outstanding |
| | ||||||
Common stock, $0.001 par value; 200,000,000 shares authorized; 89,676,739
shares issued and outstanding |
89,678 | 89,678 | ||||||
Additional paid-in capital |
127,909,082 | 127,283,524 | ||||||
Deficit accumulated during the development stage |
(82,180,739 | ) | (77,056,925 | ) | ||||
Accumulated other comprehensive loss |
(1,843 | ) | (2,090 | ) | ||||
Total stockholders equity |
45,816,178 | 50,314,187 | ||||||
Total liabilities and stockholders equity |
$ | 48,629,709 | $ | 52,798,385 | ||||
See accompanying notes to unaudited condensed consolidated financial statements.
3
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ADVENTRX Pharmaceuticals, Inc. and Subsidiaries
(A Development Stage Enterprise)
(A Development Stage Enterprise)
Condensed Consolidated Statements of Operations
(unaudited)
Inception | ||||||||||||
(June 12, 1996) | ||||||||||||
through | ||||||||||||
Three months ended March 31, | March 31, | |||||||||||
2007 | 2006 | 2007 | ||||||||||
(Note 1) | (Note 1) | |||||||||||
Revenues: |
||||||||||||
Net sales |
$ | | $ | | $ | 174,830 | ||||||
Cost of goods sold |
| | 51,094 | |||||||||
Gross margin |
| | 123,736 | |||||||||
Grant revenue |
| | 129,733 | |||||||||
Licensing revenue |
500,000 | | 500,000 | |||||||||
Total revenues |
500,000 | | 753,469 | |||||||||
Operating expenses: |
||||||||||||
Research and development |
3,384,660 | 2,483,858 | 31,542,624 | |||||||||
Selling, general and administrative |
2,809,449 | 1,735,172 | 27,380,185 | |||||||||
Depreciation and amortization |
51,889 | 37,113 | 10,484,138 | |||||||||
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 |
6,245,998 | 4,256,143 | 85,710,143 | |||||||||
Loss from operations |
(5,745,998 | ) | (4,256,143 | ) | (84,956,674 | ) | ||||||
Interest income |
622,184 | 236,527 | 2,485,243 | |||||||||
Interest expense |
| | (179,090 | ) | ||||||||
Loss before cumulative effect of change in accounting principle |
(5,123,814 | ) | (4,019,616 | ) | (82,650,521 | ) | ||||||
Cumulative effect of change in accounting principle |
| | (25,821 | ) | ||||||||
Net loss |
(5,123,814 | ) | (4,019,616 | ) | (82,676,342 | ) | ||||||
Preferred stock dividends |
| | (621,240 | ) | ||||||||
Net loss applicable to common stock |
$ | (5,123,814 | ) | $ | (4,019,616 | ) | $ | (83,297,582 | ) | |||
Loss per common share basic and diluted |
$ | (0.06 | ) | $ | (0.06 | ) | ||||||
Weighted average shares outstanding basic and diluted |
89,676,739 | 67,976,352 | ||||||||||
See accompanying notes to unaudited condensed consolidated financial statements.
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ADVENTRX Pharmaceuticals, Inc. and Subsidiaries
(A Development Stage Enterprise)
(A Development Stage Enterprise)
Condensed Consolidated Statements of Cash Flows
(unaudited)
Inception | ||||||||||||
(June 12, 1996) | ||||||||||||
through | ||||||||||||
Three months ended March 31, | March 31, | |||||||||||
2007 | 2006 | 2007 | ||||||||||
(Note 1) | (Note 1) | |||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (5,123,814 | ) | $ | (4,019,616 | ) | $ | (82,676,342 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
Depreciation and amortization |
51,889 | 37,113 | 10,034,138 | |||||||||
In-process research and development |
| | 10,422,130 | |||||||||
Share-based compensation for employee awards |
600,009 | 444,655 | 4,432,586 | |||||||||
Expense related to stock options issued to non-employees |
25,549 | 94,346 | 223,323 | |||||||||
Expenses paid by issuance of common stock |
19,583 | 88,920 | 1,282,622 | |||||||||
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 |
(282,792 | ) | (68,209 | ) | (637,433 | ) | ||||||
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 in prepaid and other assets |
(171,728 | ) | (77,976 | ) | (990,734 | ) | ||||||
Increase in accounts payable and accrued liabilities |
334,684 | 511,533 | 2,959,915 | |||||||||
Increase (decrease) in other long-term liabilities |
(5,351 | ) | | 30,323 | ||||||||
Net cash used in operating activities |
(4,551,971 | ) | (2,989,234 | ) | (46,943,825 | ) | ||||||
Cash flows from investing activities: |
||||||||||||
Purchases of short-term investments |
(13,681,067 | ) | (3,874,000 | ) | (59,404,698 | ) | ||||||
Proceeds from sales and maturities of short-term investments |
13,250,000 | 6,705,000 | 33,554,776 | |||||||||
Purchases of property and equipment |
(36,430 | ) | (18,671 | ) | (874,569 | ) | ||||||
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 (used in) investing activities |
(467,497 | ) | 2,812,329 | (26,307,303 | ) | |||||||
Cash flows from financing activities: |
||||||||||||
Proceeds from sale of preferred stock |
| | 4,200,993 | |||||||||
Proceeds from sale of common stock |
| | 84,151,342 | |||||||||
Proceeds from exercise of stock options |
| | 270,751 | |||||||||
Proceeds from sale or exercise of warrants |
| 2,425,200 | 11,382,894 | |||||||||
Repurchase of warrants |
| | (55,279 | ) | ||||||||
Payment of financing and offering costs |
| (63,620 | ) | (6,483,809 | ) | |||||||
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 |
| 2,361,580 | 94,205,701 | |||||||||
Net increase (decrease) in cash and cash equivalents |
(5,019,468 | ) | 2,184,675 | 20,954,573 | ||||||||
Cash and cash equivalents at beginning of period |
25,974,041 | 14,634,618 | | |||||||||
Cash and cash equivalents at end of period |
$ | 20,954,573 | $ | 16,819,293 | $ | 20,954,573 | ||||||
See accompanying notes to unaudited condensed consolidated financial statements.
5
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ADVENTRX Pharmaceuticals, Inc. and Subsidiaries
(A Development Stage Enterprise)
(A Development Stage Enterprise)
Notes to Condensed Consolidated Financial Statements (Unaudited)
1. | Summary of Significant Accounting Policies | |
Basis of Presentation. ADVENTRX Pharmaceuticals, Inc., a Delaware corporation (ADVENTRX, we or the Company) prepared the unaudited interim condensed consolidated financial statements 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 the Companys audited consolidated financial statements and related notes for the year ended December 31, 2006 included in the Companys Annual Report on Form 10-K filed with the SEC on March 15, 2006 (2006 Annual Report). The condensed consolidated balance sheet as of December 31, 2006 has been derived from the audited consolidated financial statements included in the 2006 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. Certain amounts in the prior periods have been reclassified to conform to the current year presentation. | ||
Since our inception, we have reported accumulated net losses of approximately $82.7 million and recurring negative cash flows from operations. In order to maintain sufficient cash and investments to fund future operations, we anticipate raising additional capital in the next 12 months through various financing alternatives including licensing or selling our technologies or through the sale of our common stock. The balance of securities available for sale under our existing shelf registration was approximately $60.0 million as of March 31, 2007. We believe our cash, cash equivalents and investments in securities of approximately $47.4 million as of March 31, 2007 will be sufficient to sustain our planned level of operations for at least the next 12 months. | ||
Principles of Consolidation. 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. Certain amounts in the prior year consolidated financial statements have been reclassified to conform to the current year presentation. | ||
Management Estimates. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts and the disclosure of contingent amounts in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. | ||
Change in Accounting Principle for Registration Payment Arrangements. In December 2006, the Financial Accounting Standards Board (FASB) issued FASB Staff Position on No. EITF 00-19-2, Accounting for Registration Payment Arrangements (FSP EITF 00-19-2). FSP EITF 00-19-2 provides that the contingent obligation to make future payments or otherwise transfer consideration under a registration payment arrangement should be separately recognized and measured in accordance with Statement of Financial Accounting Standards (FAS) No. 5, Accounting for Contingencies, which provides that loss contingencies should be recognized as liabilities if they are probable and reasonably estimable. Subsequent to the adoption of FSP EITF 00-19-2, any changes in the carrying amount of the contingent liability will result in a gain or loss that will be recognized in the consolidated statement of operations in the period the changes occur. The guidance in FSP EITF 00-19-2 is effective immediately for registration payment arrangements and the financial instruments subject to those arrangements that are entered into or modified subsequent to the date of issuance of FSP EITF 00-19-2. For registration payment arrangements and financial instruments subject to those arrangements that were entered into prior to the issuance of FSP EITF 00-19-2, this guidance is effective for our consolidated financial statements issued for the year beginning January 1, 2007, and interim periods within that year. | ||
On January 1, 2007, we adopted the provisions of FSP EITF 00-19-2 to account for the registration payment arrangement associated with our July 2005 financing (the July 2005 Registration Payment Arrangement). As of January 1, 2007 and March 31, 2007, management determined that it was not probable that we would have any payment obligation under the July 2005 Registration Payment Arrangement; therefore, no accrual for contingent obligation is required under the provisions of FSP EITF 00-19-2. Accordingly, the warrant liability account was eliminated and the comparative condensed consolidated financial statements of prior periods and as of December 31, 2006 have been adjusted to apply the new method retrospectively. The |
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following financial statement line items for the three months ended March 31, 2007 and 2006 were affected by the change in accounting principle: |
Consolidated Statements of Operations
As Computed | As Reported | |||||||||||
under | under FSP | Effect of | ||||||||||
EITF 00-19 | EITF 00-19-2 | Change | ||||||||||
Three Months Ended March 31, 2007 |
||||||||||||
Loss from operations |
$ | (5,745,998 | ) | $ | (5,745,998 | ) | $ | | ||||
Gain on fair value of warrants |
4,842,930 | | (4,842,930 | ) | ||||||||
Net loss |
(280,884 | ) | (5,123,814 | ) | (4,842,930 | ) | ||||||
Net loss per share |
$ | | $ | (0.06 | ) | $ | (0.06 | ) | ||||
Inception (June 12, 1996) Through March 31, 2007 |
||||||||||||
Loss from operations |
$ | (84,956,674 | ) | $ | (84,956,674 | ) | $ | | ||||
Loss on fair value of warrants |
(7,396,758 | ) | | 7,396,758 | ||||||||
Net loss |
(90,073,100 | ) | (82,676,342 | ) | 7,396,758 | |||||||
Net loss applicable to common stock |
(90,694,340 | ) | (83,297,582 | ) | 7,396,758 |
As Originally | Effect of | |||||||||||
Reported | As Adjusted | Change | ||||||||||
Three Months Ended March 31, 2006 |
||||||||||||
Loss from operations |
$ | (4,256,143 | ) | $ | (4,256,143 | ) | $ | | ||||
Loss on fair value warrants |
(17,027,065 | ) | | 17,027,065 | ||||||||
Net loss |
(21,046,681 | ) | (4,019,616 | ) | 17,027,065 | |||||||
Net loss per share |
$ | (0.31 | ) | $ | (0.06 | ) | $ | 0.25 | ||||
Inception (June 12, 1996)Through March 31, 2006 |
||||||||||||
Loss from operations |
$ | (53,630,352 | ) | $ | (53,630,352 | ) | $ | | ||||
Loss on fair value warrants |
(28,606,725 | ) | | 28,606,725 | ||||||||
Net loss |
(81,507,124 | ) | (52,900,399 | ) | 28,606,725 | |||||||
Net loss applicable to common stock |
(82,128,364 | ) | (53,521,639 | ) | 28,606,725 |
Consolidated Balance Sheet
As Computed | As Reported | |||||||||||
under | under FSP | Effect of | ||||||||||
EITF 00-19 | EITF 00-19-2 | Change | ||||||||||
March 31, 2007 |
||||||||||||
Warrant liability |
$ | 25,513,509 | $ | | $ | (25,513,509 | ) | |||||
Total liabilities |
28,327,040 | 2,813,531 | (25,513,509 | ) | ||||||||
Additional paid-in capital |
109,792,331 | 127,909,082 | 18,116,751 | |||||||||
Deficit accumulated during the development stage |
(89,577,497 | ) | (82,180,739 | ) | 7,396,758 | |||||||
Total stockholders equity |
20,302,669 | 45,816,178 | 25,513,509 |
As Originally | Effect of | |||||||||||
Reported | As Adjusted | Change | ||||||||||
December 31, 2006 |
||||||||||||
Warrant liability |
$ | 30,356,439 | $ | | $ | (30,356,439 | ) | |||||
Total liabilities |
32,840,637 | 2,484,198 | (30,356,439 | ) | ||||||||
Additional paid-in capital |
109,166,773 | 127,283,524 | 18,116,751 | |||||||||
Deficit accumulated during the development stage |
(89,296,613 | ) | (77,056,925 | ) | 12,239,688 | |||||||
Total stockholders equity |
19,957,748 | 50,314,187 | 30,356,439 |
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As a result of the accounting change, the cumulative effect of the change on our consolidated
stockholders equity as of January 1, 2006 is as follows:
As Originally | Effect of | |||||||||||
Reported | As Adjusted | Change | ||||||||||
January 1, 2006 |
||||||||||||
Additional paid-in capital |
$ | 52,105,329 | $ | 70,222,080 | $ | 18,116,751 | ||||||
Deficit accumulated during the development stage |
(59,964,840 | ) | (48,385,180 | ) | 11,579,660 | |||||||
Total stockholders equity (deficit) |
(7,828,616 | ) | 21,867,795 | 29,696,411 |
Consolidated Statements of Cash Flows
As Computed | As Reported | |||||||||||
under | under FSP | Effect of | ||||||||||
EITF 00-19 | EITF 00-19-2 | Change | ||||||||||
March 31, 2007 |
||||||||||||
Net loss |
$ | (280,884 | ) | $ | (5,123,814 | ) | $ | (4,842,930 | ) | |||
Gain on value of warrant liability |
(4,842,930 | ) | | 4,842,930 | ||||||||
Inception (June 12, 1996) through March 31, 2007 |
||||||||||||
Net loss |
$ | (90,073,100 | ) | $ | (82,676,342 | ) | $ | 7,396,758 | ||||
Loss on value of warrant liability |
7,396,758 | | (7,396,758 | ) |
As Originally | Effect of | |||||||||||
Reported | As Adjusted | Change | ||||||||||
March 31, 2006 |
||||||||||||
Net loss |
$ | (21,046,681 | ) | $ | (4,019,616 | ) | $ | 17,027,065 | ||||
Loss on value of warrant liability |
17,027,065 | | (17,027,065 | ) | ||||||||
Inception (June 12, 1996) through March 31, 2006 |
||||||||||||
Net loss |
$ | (81,507,124 | ) | $ | (52,900,399 | ) | $ | 28,606,725 | ||||
Loss on value of warrant liability |
28,606,725 | | (28,606,725 | ) |
Income Taxes. In July 2006, FASB issued FASB Interpretation No. 48, Accounting for
Uncertainty in Income Taxes-an Interpretation of FASB Statement 109 (FIN 48), which clarifies
the accounting for uncertainty in tax positions. FIN 48 provides that the tax effects from an
uncertain tax position can be recognized in our consolidated financial statements only if the
position is more likely than not of being sustained upon an
examination by tax authorities. An uncertain income tax position will
not be recognized if it has less than a 50% likelihood of being
sustained. Additionally, FIN 48 provides
guidance on derecognition, classification, interest and penalties,
accounting in interim periods, disclosure and transition. The
provisions of FIN 48 are effective for us as of January 1, 2007, with the cumulative effect of
the change in accounting principle recorded as an adjustment to opening retained earnings in the
year of adoption. We adopted FIN 48 on January 1, 2007,
which did not have a material impact on our
consolidated results of operations or financial position. See
Note 4.
Computation of Net Loss per Common Share. We calculate basic and diluted net loss per common
share in accordance with the FAS No. 128, Earnings Per Share. Basic net loss per common share was
calculated by dividing the net loss for the period by the
weighted-average number of common shares outstanding during the period, without consideration for common stock equivalents. Diluted
net loss per common share was calculated by dividing the net loss for the period by the weighted-average
number of common stock equivalents outstanding during the period. For purposes of this
calculation, 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. We have
excluded the following options and warrants from the calculation of diluted net loss per common
share for the three months ended March 31, 2007 and 2006 because their effect is anti-dilutive:
Three Months Ended March 31, | ||||||||
2007 | 2006 | |||||||
Warrants |
13,458,549 | 17,737,100 | ||||||
Options |
4,297,957 | 3,113,000 | ||||||
17,756,506 | 20,850,100 | |||||||
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 March 31,
2007 and 2006 and the period from inception (June 12, 1996)
through March 31, 2007, comprehensive loss was
$5.1 million, $4.0 million and $82.7 million, respectively.
8
Table of Contents
Share-Based Payments. Estimated share-based compensation expense related to stock options granted
to employees for the three months ended March 31, 2007 and 2006 was as follows:
Three Months Ended March 31, | ||||||||
2007 | 2006 | |||||||
Selling, general and administrative expense |
$ | 346,305 | $ | 311,195 | ||||
Research and development expense |
253,704 | 133,460 | ||||||
Share-based compensation expense before taxes |
600,009 | 444,655 | ||||||
Related income tax benefits |
| | ||||||
Share-based compensation expense |
$ | 600,009 | $ | 444,655 | ||||
Net share-based compensation expense per common share basic and diluted |
$ | 0.01 | $ | 0.01 | ||||
Since we
have a net operating loss carryforward as of March 31, 2007, no excess tax
benefits for the tax deductions related to share-based awards were recognized in the condensed
consolidated statement of operations. There were no employee stock options exercised in the three
months ended March 31, 2007 and 2006.
At
March 31, 2007, total unrecognized estimated compensation cost related to nonvested employee
share-based awards granted prior to that date was $5.2 million, which is expected to be
recognized over a weighted-average period of 3.5 years. During the three months ended March 31,
2007 and 2006, we granted 652,333 and 656,000 stock options, respectively, to our employees with
the estimated weighted-average grant-date fair value of $2.51 and $3.35 per share, respectively.
The assumptions used in the Black-Scholes option-valuation model to estimate the grant-date fair
value for employee option grants during the three months ended March 31, 2007 and 2006 are as
follows:
Three Months Ended March 31, | ||||||||
2007 | 2006 | |||||||
Weighted expected volatility |
138.1 | % | 89.5 | % | ||||
Expect term (in years) |
6.1 | 5.0 | ||||||
Risk-free interest rate |
4.7 | % | 4.1% 4.52 | % | ||||
Dividend yield |
0 | 0 |
Supplementary Cash Flow Information. Noncash investing and financing transactions excluded
from the condensed consolidated statements of cash flows for the three months ended March 31,
2007 and 2006 and for the period from inception (June 12, 1996) through March 31, 2007 are as
follows:
Inception | ||||||||||||
(June 12, 1996) | ||||||||||||
Three months ended March 31, | through | |||||||||||
2007 | 2006 | March 31, 2007 | ||||||||||
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 |
| | 2,705 | |||||||||
Acquisitions |
| | 24,781,555 | |||||||||
Payment of dividends |
| | 213,000 | |||||||||
Financial advisor services in conjunction with private
placement |
| | 1,137,456 | |||||||||
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 |
| 13 | 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 | |||||||||
Unrealized (gain) loss on short-term investments |
(247 | ) | 964 | 1,843 |
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Recent Accounting Pronouncements. In February 2007, FASB issued FAS No. 159, The Fair Value Option for Financial Assets and Financial Liabilities (FAS 159), which gives companies the option to measure eligible financial assets, financial liabilities and firm commitments at fair value (i.e., the fair value option), on an instrument-by-instrument basis, that are otherwise not permitted to be accounted for at fair value under other accounting standards. The election to use the fair value option is available when an entity first recognizes a financial asset or liability or upon entering into a firm commitment. Subsequent changes in fair value must be recorded in earnings. FAS 159 is effective for financial statements issued for fiscal year beginning after November 15, 2007. We do not expect adoption of FAS 159 will have a material impact on our consolidated results of operations or financial position. | ||
2. | Registration Payment Arrangement | |
On July 21, 2005, we entered into a securities purchase agreement (the Agreement) with certain accredited institutional investors (the Purchasers) for the sale of 10,810,809 shares of our common stock (the Shares) at a purchase price of $1.85 per share for aggregate gross proceeds of $19,999,997. In connection with this financing, we issued the Purchasers seven-year warrants to purchase 10,810,809 shares of our common stock (the Warrant Shares) at an exercise price of $2.26 per share. We received net proceeds of $18,313,751, after deducting commissions and offering fees and expenses, which included cash payments of $1,403,000 to placement agents and $283,246 in legal and accounting fees. | ||
Pursuant to the terms of the Agreement, if (i) a registration statement covering (A) all of the Shares and the Warrant Shares and (B) any other shares of common stock issued or issuable in respect to the Shares and the Warrant Shares because of stock splits, stock dividends, reclassifications, recapitalizations or similar events (together, the Registrable Shares) required to be covered thereby and required to be filed by us is (A) not filed with the SEC on or before 45 days after the closing of such financing (a Filing Failure) or (B) if such registration statement is not declared effective by the SEC on or before 90 days after the closing of such financing (an Effectiveness Failure) or (ii) on any day after the effective date of the registration statement sales of all the Registrable Shares required to be included on such registration statement cannot be made (other than as permitted during a suspension pursuant to the Agreement) pursuant to such registration statement (including, without limitation, because of a failure to keep the registration statement effective, to disclose such information as is necessary for sales to be made pursuant to such registration statement or to register sufficient shares of Shares) (a Maintenance Failure), then, we will be obligated, without limiting any other remedies of any Purchaser, to pay as liquidated damages (the Liquidated Damages) for such failure and not as a penalty to any Purchaser an amount in cash determined in accordance with the formula set forth below: |
| For each 30-day period that a Filing Failure, Effectiveness Failure or Maintenance Failure remains uncured, we will pay an amount equal to the purchase price paid to us for all Shares then held by such Purchaser multiplied by 1% for the first 30-day period or any portion thereof and increasing by an additional 1% with regard to each additional 30-day period until such Filing Failure, Effectiveness Failure or Maintenance Failure is cured. | ||
| For any partial 30-day period in which a Filing Failure, Effectiveness Failure or Maintenance Failure exists but is cured prior to the end of the 30-day period, we will pay the Purchasers a pro rata portion of the amount which would be due if the failure continued for the entire 30-day period. For example, if the purchase price paid for all Shares then held by a Purchaser is $5,000,000, then, (a) at the end of the 30th day, the Liquidated Damages would be 1% or $50,000, (b) at the end of the 60th day, the Liquidated Damages for the first 30-day period would have been 1% or $50,000 and for the second 30-day period would be 2% or $100,000, and (c) at the end of the 105th day, the Liquidated Damages for the first 30-day period would have been 1% or $50,000, for the second 30-day period 2% or $100,000, for the third 30-day period 3% or $150,000, and for the final 15-day period, 4% applied pro rata to such 15 days, or $100,000. |
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There is no cap to the amount of Liquidated Damages that we may be obligated to pay. Payments to be made pursuant to the July 2005 Registration Payment Arrangement will be due and payable to the Purchasers at the end of each calendar month during which Liquidated Damages will have accrued. No Liquidated Damages will be due or payable to a Purchaser in any event if as of the date of the Filing Failure, Effectiveness Failure or Maintenance Failure such Purchaser could sell all of the Registrable Shares such Purchaser then holds without registration by reason of Rule 144(k) of the Securities Act. | ||
The registration statement was filed and declared effective by the SEC on September 2, 2005, which was within the allowed time. As of May 4, 2007, we have not incurred nor paid any Liquidated Damages in connection with the July 2005 Registration Payment Arrangement. | ||
Effective January 1, 2007, we accounted for the July 2005 Registration Payment Arrangement under the provisions of FSP EITF 00-19-2. See Note 1, Significant Accounting Policies Change in Accounting Principle for Registration Payment Arrangement, for a detailed discussion. As of May 4, 2007, management determined that it is not probable that we will be obligated to pay any Liquidated Damages in connection with the July 2005 Registration Payment Arrangement. Accordingly, no accrual for contingent obligation is required at March 31, 2007. | ||
3. | License Fee Revenue | |
In October 2006, we entered into a license agreement with Theragenex, LLC, a life science and technology company. Under the agreement, we granted Theragenex exclusive rights to develop and commercialize ANX-211, or chitosan gel, in the U.S. in exchange for a licensing fee of $1.0 million ($500,000 of which we received in January 2007, with the remainder due in June 2007), a $1.0 million milestone payment that will be due within 45 days of the launch of each licensed product, and royalties of 15% to 20% on licensed product sales by Theragenex or its sublicensees or affiliates, depending on sales levels. Theragenex, through its wholly-owned subsidiary, TRx Pharma, plans to launch the first licensed product, ZANAFLU®, in the 2007 cold and influenza season. The license agreement remains in effect through the later of the latest date on which the last licensed product is covered by a valid patent claim or 20 years from the date of the first commercial sale of the last licensed product. Either party may terminate the agreement if the other materially breaches or materially defaults in the performance or observance of any of the provisions of the agreement. In addition, either party may, upon notice, terminate the agreement, if the other party admits in writing that it is generally unable to meet its debts when due, or upon the filing of bankruptcy, reorganization, liquidation or receivership proceedings involving such party. Theragenex may terminate the agreement at any time, upon 90 days written notice, if Theragenex concludes in good faith, based on technical information learned by it following execution of the agreement, that there is no reasonable likelihood of a commercially viable licensed product. In accordance with the provisions of the SECs Staff Accounting Bulletin Topic 13, Revenue Recognition (Topic 13), we recognized $500,000 of the license fee as revenue in the three months ended March 31, 2007, because our performance obligations were complete, collectibility was assured and we had no continuing obligations for performance under the agreement. | ||
4. | Income Taxes | |
We adopted the provisions of FIN 48 on January 1, 2007, which did not materially impact our consolidated results of operations or financial position. No unrecognized tax benefits were recorded as of the date of adoption. As a result of the implementation of FIN 48, we did not recognize any liability for unrecognized tax benefits. There are no unrecognized tax benefits included in the balance sheet that would, if recognized, affect the effective tax rate. | ||
Our policy is to recognize interest and/or penalties related to income tax matters in income tax expense. We had no accrual for interest or penalties on our consolidated balance sheets at March 31, 2007 and at December 31, 2006, and have not recognized interest and/or penalties in the consolidated statement of operations for the three months ended March 31, 2007. | ||
At January 1, 2007, we had net deferred tax assets of $20.0 million. The deferred tax assets are primarily composed of federal and state tax net operating loss carryfowards, federal and state R&D credit carryforwards, share-based compensation expense and intangibles. Due to uncertainties surrounding our ability to generate future taxable income to realize these assets, a full valuation allowance has been established to offset our net deferred tax asset. Additionally, the future utilization of our net operating loss and R&D credit carryforwards to offset future taxable income may be subject to a substantial annual limitation as a result of ownership changes that may have occurred previously or that could occur in the future. We have not yet determined whether such an ownership change has occurred, however, we plan to complete a Section 382/383 analysis regarding the limitation of the net operating losses and research and development credits. When this analysis is completed, we plan to update our unrecognized tax benefits under FIN 48. Therefore, we expect that the unrecognized tax benefits may change within 12 months of this reporting date. At this time, we cannot estimate how much the unrecognized tax benefits may change. Any carryforwards that will expire prior to utilization as a result of such limitations will be removed from deferred tax assets with a corresponding reduction of the valuation allowance. Due to the existence of the valuation allowance, future changes in our unrecognized tax benefits will not impact our effective tax rate. | ||
5. | Commitments and Contingencies | |
In the normal course of business, we may become subject to lawsuits and other claims and proceedings. Such matters are subject to uncertainty. Management is not aware of any pending or threatened lawsuit or proceedings that would have a material adverse effect on our consolidated financial position, results of operations or cash flows. |
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Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should
be read in conjunction with the consolidated financial statements and related notes appearing
elsewhere in this report. In addition to historical information, this discussion and analysis
contains forward-looking statements that involve risks, uncertainties, and assumptions. Our actual
results may differ materially from those anticipated in these forward-looking statements as a
result of certain factors, including but not limited to those set forth under Item 1A of Part II,
Risk Factors.
Forward Looking Statements
This Quarterly Report on Form 10-Q, particularly in Item 2 Managements Discussion and Analysis of
Financial Condition and Results of Operations, includes forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended. All statements, other than statements of historical fact, are
statements that could be deemed forward-looking statements, including, but not limited to,
statements regarding our future financial position, business strategy, clinical trials, partnering
arrangements and plans and objectives of management for future operations. When used in this
report, the words believe, may, could, will, estimate, continue, anticipate,
intend, expect and similar expressions are intended to identify forward-looking statements.
We have based these forward-looking statements largely on our current expectations and projections
about future events and financial trends that we believe may affect our financial condition,
results of operations, business strategy, short-term and long-term business operations and
objectives, and financial needs. These forward-looking statements are subject to certain risks and
uncertainties that could cause our actual results to differ materially from those expressed or
implied in these forward-looking statements. Factors that could cause or contribute to such
differences include, but are not limited to, those discussed in Item 1A of Part I, Risk Factors,
in our Annual Report on Form 10-K for the year ended December 31, 2006 and those discussed in
other documents we filed with the Securities and Exchange Commission. Except as required by law, we
do not intend to update these forward-looking statements publicly or to update the reasons actual
results could differ materially from those anticipated in these forward-looking statements, even if
new information becomes available in the future.
In light of these risks, uncertainties and assumptions, the forward-looking events and
circumstances discussed in this report and in the documents incorporated in this report may not
occur and actual results could differ materially and adversely from those anticipated or implied in
such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on
such forward-looking statements.
Overview
We are a biopharmaceutical research and development company focused on commercializing proprietary
product candidates for the treatment of cancer and infectious diseases. We seek to improve the
performance and safety of existing therapeutic products by addressing significant problems such as
drug metabolism, bioavailability, excessive toxicity and treatment resistance. Our research and
development programs include full clinical and preclinical
development programs for new chemical entities for the treatment of
various cancers and for the treatment of human immunodeficiency
virus, or HIV. We are also developing novel emulsion formulations of
several currently marketed products for which we anticipate seeking marketing approval under
Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, or FDCA, which may allow us to obtain
marketing approval of these product candidates on timelines shorter than those associated with
traditional development of new chemical entities. We have licensed the U.S. rights to ANX-211, or
chitosan gel, to Theragenex LLC that has the potential of generating milestone payments and
royalties on product sales beginning in late 2007, and we are in active licensing discussions
regarding several of our drug candidates, including our lead product candidate ANX-510 (CoFactor®).
We are currently engaged in clinical development of CoFactor for the treatments of metastatic
colorectal cancer and advanced breast cancer. In mid-2006, we began a 1,200-patient Phase 3
clinical trial of CoFactor for the treatment of metastatic colorectal cancer. Enrollment in this
trial is currently underway and we anticipate completing enrollment in 2008. Our 300-patient, Phase
2b clinical trial of CoFactor for the treatment of metastatic colorectal cancer is nearing
completion and we expect to announce results later in 2007. Also, in December 2006 we began a
31-patient Phase 2 clinical trial of CoFactor for the treatment of advanced breast cancer.
Enrollment for that trial is also underway and we anticipate completing enrollment later in 2007.
We are also engaged in clinical development of ANX-530 (vinorelbine emulsion), a new formulation of
vinorelbine tartrate, for the treatment of non-small cell lung cancer. We anticipate seeking
marketing approval of ANX-530 under Section 505(b)(2) of the FDCA.
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In
December 2006, we initiated a 28-patient bioequivalency clinical
trial of ANX-530 compared with the currently marketed drug,
vinorelbine tartrate. The United States Food
and Drug Administration, or FDA, previously indicated that a single 28-patient clinical trial that
demonstrates bioequivalence between our emulsion formulation of vinorelbine and the currently
marketed product should be sufficient to support filing a new drug application, or NDA, with the
FDA. Patient recruitment in the study began in the first quarter of 2007. We anticipate completing
enrollment and final data analysis in the second half of 2007. If the study demonstrates
bioequivalence, we expect to file an NDA for ANX-530 with the FDA by the end of 2007.
We are engaged in preclinical development of several other product candidates for both cancer and
infectious diseases. Preclinical development of ANX-201 (thiophosphonoformate) for the treatment of
HIV is ongoing, and we anticipate filing an Investigational New
Drug Application, or IND, and initiating a Phase 1/2 clinical trial later in 2007. Additionally, we
are engaged in preclinical pharmacokinetic testing of our emulsion formulation product candidates
ANX-016 (vancomycin emulsion), for the treatment of certain bacterial infections, and ANX-514
(docetaxel emulsion), for the treatment of certain cancers. Furthermore, we are evaluating
potential clinical development of ANX-015 (clarithromycin emulsion). We could commence clinical
evaluation on one or more of these emulsion formulation product candidates by the end of 2007. If
we are successful in obtaining the FDAs concurrence in applying the provisions in Section 505
(b)(2), such clinical evaluation work should constitute a marketing-enabling study.
In connection with licensed products, we anticipate that Theragenex, through its wholly-owned
subsidiary, TRx Pharma, will launch the first licensed product, ZANAFLU®, for the treatment of the
common cold and influenza for the 2007 cold and influenza season. In October 2006, we licensed U.S.
rights to ANX-211, one of our proprietary antiviral products, to Theragenex in consideration of a
licensing fee, milestone payments and royalty payments of 15% to 20% on licensed product sales by
Theragenex or its subsidiaries or affiliates, depending on the sales level. During the three months
ended March 31, 2007, Theragenex paid $500,000, or one-half of the license fee, to us, with the
balance of the fee due in mid-2007. The license agreement also requires a $1.0 million payment to
us shortly following the launch of each licensed product.
We have additional product candidates in our portfolio that we are currently evaluating for future
preclinical and clinical development. We intend to continue to build a portfolio of product
candidates for the treatment of cancer and infectious diseases that reflect an appropriate balance
between the longer-term regulatory pathway associated with traditional drug development and the
shorter regulatory timelines available under Section 505(b)(2).
We have incurred annual net losses since inception, and as of March 31, 2007, our accumulated net
losses amounted to $82.7 million. Because we are a development stage company that has not yet
marketed any products or generated any significant revenue, we intend to raise additional capital
to fund operations through the receipt of fees, milestone payments and royalties from license
arrangements, and through other forms of financing such as debt financing, royalty-based financing,
or sales of shares of our common or preferred stock.
We expect that our research, development, selling, marketing and other operating costs will
continue to exceed revenues from existing sources for the foreseeable future. Our total operating
expenses are influenced substantially by the amount of spending devoted to our research and
development programs. During the last three years, we have expanded our product candidate pipeline,
which requires that we allocate significant amounts of our resources to such programs, including
increased spending on clinical trials as those programs advance. We expect research and development
expenses will represent at least 60% of our operating expenses for 2007. We expect that selling,
general and administrative expenses for 2007 will represent less than 40% of our operating
expenses. Trends in various types of expenses and revenues are discussed further under Results of
Operations.
We expect that we will need to raise additional capital if we continue as planned our Phase 3
clinical trial of CoFactor for the treatment of metastatic colorectal cancer without a partner. Our
need to raise capital through sales of our securities will depend substantially on our ability to
earn revenues through fees, milestone payments and royalties under partnering arrangements
regarding our product candidates, including the ability of existing and potentially new partners to
generate sales and achieve milestones under such arrangements. If we are unable to raise additional
capital as needed to fund our operations, whether through sales of our securities or partnering
arrangements, then we may need to slow the rate of development of some of our research and
development programs, in particular our Phase 3 and Phase 2b clinical trials of CoFactor, and our
development plans for CoFactor and our other product candidates may be adversely affected.
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Critical Accounting Policies
Our discussion and analysis of our financial condition and results of operations is based upon
unaudited consolidated financial statements that we have prepared in accordance with U.S. GAAP. The
preparation of these consolidated financial statements requires management to make a number of
assumptions and estimates that affect the reported amounts of assets, liabilities, revenues and
expenses in our consolidated financial statements and accompanying notes. On an on-going basis, we
evaluate these estimates and assumptions, including those related to recognition of expenses in
research contracts, expenses in research and development, expenses in share-based compensation and
registration payment arrangements. Management bases its estimates on historical information and
assumptions believed to be reasonable under the circumstances, the results of which form the basis
for making judgments about the carrying values of assets and liabilities not readily apparent from
other sources. Actual results may differ from these estimates under different assumptions or
conditions.
Change
in Accounting Principle for Registration Payment Arrangements. In December 2006, the FASB
issued FSP EITF 00-19-2, Accounting for Registration Payment Arrangements. FSP EITF 00-19-2
provides that a contingent obligation to make future payments or otherwise transfer consideration
under a registration payment arrangement is separately recognized and measured in accordance with
FAS 5 which provides that loss contingencies should be recognized as liabilities if they are
probable and reasonably estimable. On January 1, 2007, the first day of our fiscal year ending
December 31, 2007, we adopted the provisions of FSP EITF 00-19-2 to account for an outstanding
registration payment arrangement. The comparative consolidated financial statements of prior
periods have been adjusted to apply the new method retrospectively. See Note 1 in Notes to
Condensed Consolidated Financial Statements (unaudited), Change in Accounting Principle for
Registration Payment Arrangements, for a detailed discussion.
Income Taxes. In July 2006, FASB issued FIN 48, Accounting for Uncertainty in Income Taxes-an
Interpretation of FASB Statement 109, which clarifies the accounting for uncertainty in tax
positions. FIN 48 provides that the tax effects from an uncertain tax position can be recognized in
our consolidated financial statements only if the position is more likely than not of being
sustained upon an examination by tax authorities. An uncertain income
tax position will not be recognized if it has less than a 50% likelihood of being sustained. Additionally,
FIN 48 provides guidance on derecognition, classification,
interest and penalties, accounting in interim periods, disclosure and
transition. The provisions of FIN 48 are effective for us as
of January 1, 2007, with the cumulative effect of the change in accounting principle recorded as an
adjustment to opening retained earnings in the year of adoption. We
adopted FIN 48 on January 1, 2007, which did not have a material impact on our consolidated results of operations or financial
position.
Revenue Recognition. We recognize revenue in accordance with Topic 13, Revenue Recognition, and
EITF No. 00-21, Revenue Arrangements with Multiple Deliverables, or EITF 00-21. Revenue is
recognized when all of the following criteria are met: (1) persuasive evidence of an arrangement
exists; (2) delivery has occurred or services have been rendered; (3) the sellers price to the
buyer is fixed and determinable; and (4) collectibility is reasonably assured.
Revenue from licensing agreements is recognized based on the performance requirements of the
agreement. Revenue is deferred for fees received before earned. Nonrefundable upfront fees that are
not contingent on any future performance by us are recognized as revenue when revenue recognition
criteria under Topic 13 and EITF 00-21 are met and the license term commences. Nonrefundable
upfront fees, where we have an ongoing involvement or performance obligations, are recorded as
deferred revenue and recognized as revenue over the life of the contract, the period of the
performance obligation or the development period, whichever is appropriate in light of the
circumstances.
Payments related to substantive, performance-based milestones in an agreement are recognized as
revenue upon the achievement of the milestones as specified in the underlying agreements when they
represent the culmination of the earnings process. Royalty revenue from licensed products will be
recognized when earned in accordance with the terms of the license agreements.
Recognition of Expenses in Research Contracts. Pursuant to managements assessment of the services
that have been performed on clinical trials and other contracts, we recognize expenses as the
services are provided. Such management assessments generally consist of, but are not limited to, an
evaluation by the project manager of the work that has been completed during the period,
measurement of progress prepared internally and/or provided by the third-party service provider,
analysis of data that justifies the progress, and finally, managements judgment. Several of our
contracts extend across multiple reporting periods, including our largest contract, with a contract
research organization representing a $9.0 million commitment over the life of the contract. A 3%
variance in our estimate of the work completed in our largest contract could increase or decrease
our operating expenses by approximately $270,000.
Research and Development Expenses. Research and development, or R&D, expenses consist of expenses
incurred in performing research and development activities, including salaries and benefits,
facilities and other overhead expenses, clinical trials, contract services and other outside
expenses. Research and development expenses are charged to operations as they are incurred.
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Payments made in connection with in-licensed technology or product candidates are expensed as
incurred when there is uncertainty in receiving future economic benefits from the licensed
technology or product candidates. We consider the future economic benefits from the licensed
technology or product candidates to be uncertain until such licensed technology or product
candidates are approved by the FDA or when other significant risk factors are abated. For expense
accounting purposes, management has viewed future economic benefits for all of our licensed
technology or product candidates to be uncertain.
Purchased In-Process Research and Development. In accordance with FAS No. 141, Business
Combinations, we immediately charge the costs associated with purchased in-process research and
development, or IPR&D, to statement of operations upon acquisition. These amounts represent an
estimate of the fair value of purchased IPR&D for projects that, as of the acquisition date, had
not yet reached technological feasibility, had no alternative future use, and had uncertainty in
receiving future economic benefits from the purchased IPR&D. We determine the future economic
benefits from the purchased IPR&D to be uncertain until such technology is approved by the FDA or
when other significant risk factors are abated. We incurred significant IPR&D expense related to
our acquisition of SD Pharmaceuticals, Inc.
Share-based Compensation Expenses. Effective January 1, 2006, we accounted for share-based
compensation awards granted to employees in accordance with the revised FAS No. 123, Share-Based
Payment, or FAS 123R, including the provisions of Staff Accounting Bulletin No. 107. Share-based
compensation cost is measured at the grant date, based on the estimated fair value of the award,
and is recognized as expense over the employees requisite service period. We have no awards with
market or performance conditions. As share-based compensation expense is based on awards ultimately
expected to vest, it has been reduced for estimated forfeitures. FAS 123R requires forfeitures to
be estimated at the time of grant and revised, if necessary, in subsequent periods if actual
forfeitures differ from those estimates. Forfeitures were estimated based on historical experience.
Although estimates of share-based compensation expenses are significant to our consolidated
financial statements, they are not related to the payment of any cash by us. Prior to January 1,
2006, we accounted for share-based compensation under the recognition and measurement principles of
FAS 123, Accounting for Stock-Based Compensation.
We estimate the fair value of stock option awards on the date of grant using the Black-Scholes
option-pricing model, or Black-Scholes model. The determination of the fair value of share-based
payment awards on the date of grant using an option-pricing model is affected by our stock price as
well as assumptions regarding a number of complex and subjective variables. These variables
include, but are not limited to, our expected stock price volatility over the term of the awards,
actual and projected employee stock option exercise behaviors, a risk-free interest rate and
expected dividends. We may elect to use different assumptions under the Black-Scholes option
valuation model in the future, which could materially affect our net income or loss and net income
or loss per share.
We account for share-based compensation awards granted to non-employees in accordance with EITF No.
96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or
in Conjunction with Selling, Goods or Services, or EITF 96-18. Under EITF 96-18, we determine the
fair value of the share-based compensation awards granted as either the fair value of the
consideration received or the fair value of the equity instruments issued, whichever is more
reliably measurable. If the fair value of the equity instruments issued is used, it is measured
using the stock price and other measurement assumptions as of the earlier of either of (1) the date
at which a commitment for performance by the counterparty to earn the equity instruments is reached
or (2) the date at which the counterpartys performance is complete.
The above listing is not intended to be a comprehensive list of all of our accounting policies. In
most cases, the accounting treatment of a particular transaction is specifically dictated by U.S.
GAAP.
Results of Operations
Comparison of Three Months Ended March 31, 2007 and 2006
Revenue. Revenue for the three months ended March 31, 2007 amounted to $500,000, compared to no
revenue for the same period a year ago. Revenue in the first quarter of fiscal year 2007 represents
a $500,000 nonrefundable license fee paid under our license agreement with Theragenex. We
recognized the license fee as revenue in the period our performance obligations were complete at
the time of payment and there were no continuing obligations for us to perform under the agreement.
The Theragenex license represents the first license of our technology to a third party. We
anticipate that licensing, partnering, and other collaborations will increase in importance as part
of our business development strategy through 2007 and 2008; and we are in active discussions with
other companies regarding potential arrangements for certain of our other product candidates.
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Research and Development Expenses. R&D expenses increased by $901,000, or 36%, to $3.4 million for
the three months ended March 31, 2007, compared to $2.5 million for the comparable period in 2006.
The increase in R&D expenses was primarily related to a $390,000 increase in employee compensation
and related costs related to an increase in R&D personnel and a $377,000 increase in R&D expenses
related to CoFactor for the treatment of metastatic colorectal cancer and treatment of advanced
breast cancer, ANX-530 for the treatment of non-small cell lung cancer, and ANX-201 for the
treatment of HIV.
We expect that our R&D expenses will continue to increase beyond the level of expenses incurred in
the three months ended March 31, 2007 as we continue to ramp up enrollments in our clinical trials,
including our Phase 3 clinical trial of CoFactor for the treatment of metastatic colorectal cancer.
The amount of the increase in expense will be directly related to the success and speed of patient
enrollment in these trials.
Selling, General and Administrative Expenses. Selling, general and administrative, or SG&A,
expenses increased by $1.1 million, or 62%, to $2.8 million for the three months ended March 31,
2007, compared to $1.7 million for the comparable period in 2006. The increase in SG&A expenses was
due to a $472,000 increase in employee compensation and related costs, a $252,000 increase in legal
fees related to patent costs, and a $179,000 increase in market research for our product
candidates. We expect that SG&A expenses will continue to increase modestly through 2007 to support
increased R&D activity and personnel.
Interest Income. Interest income for the three months ended March 31, 2007 was $622,000 compared to
$237,000 for the comparable period in 2006. The increase was attributable to higher invested
balances from funds received from our most recent equity financing, which we completed in November
2006, and a higher average interest rate yield on these balances.
Liquidity and Capital Resources
Since our inception we have funded our operations primarily through sales of our equity securities.
As of March 31, 2007, we had cash and cash equivalents and short-term investments in securities
totaling $47.4 million, compared to $51.7 million as of December 31, 2006. The decrease in cash
and investments in securities was attributed to cash used for operations. As of March 31, 2007 we
held $21.0 million in cash and cash equivalents and $26.4 million in short-term investments in
securities.
Operating Activities. Net cash used in operating activities was $4.6 million during the three
months ended March 31, 2007, compared to $3.0 million during the three months ended March 31, 2006.
The increase in net cash used in operating activities was due to an increase in payments for
research and development activities, primarily related to CoFactor for the treatment of metastatic
colorectal cancer and treatment of advanced breast cancer, ANX-530 and ANX-201.
Investing Activities. Net cash used in investing activities was $467,000 during the three months
ended March 31, 2007 compared to net cash provided by investing activities of $2.8 million during
the three months ended March 31, 2006. Net cash used in investing activities in the first quarter
of 2007 was primarily for purchases of short-term investments in securities, net of proceeds from
sales and maturities of short-term investments in securities. Cash provided by investing activities
in the comparable period in 2006 was primarily attributable to proceeds from sales and maturities
of short-term investments in securities, net of purchases of short-term investments in securities.
Financing Activities. No financing activities were conducted during the three months ended March
31, 2007. Net cash provided by financing activities amounted to $2.4 million for the three months
ended March 31, 2006. Net cash provided by financing activities in 2006 was primarily proceeds from
the exercise of warrants.
Management Outlook
We believe that cash, cash equivalents, and short-term investments of approximately $47.4 million
at March 31, 2007 should be sufficient to sustain our planned level of operations for at least the
next twelve months. We expect that our cash requirements will be from $6.0 million to $8.0 million
in each of the remaining quarters in 2007, as we continue developing our existing product
candidates and pipeline. In order to maintain sufficient cash and investments to fund future
operations longer term, and to continue developing our existing product candidates, we will need to
raise additional capital from time to time, and may do so through various financing alternatives,
including selling shares of our common or preferred stock and rights to acquire our common or
preferred stock, licensing or selling our technologies and product candidates, or through the
issuance of one or more forms of senior or subordinated debt. The balance of securities available
for sale under our existing shelf registration was approximately $60.0 million as of March 31,
2007. If we are unable to raise capital as needed to fund future operations, then we may defer or abandon
one or more of our clinical or preclinical research programs and may need to take additional
cost-cutting measures.
16
Table of Contents
During the remainder of 2007, we expect to recognize an additional $1.5 million from the licensing
of ANX-211 to Theragenex, and may recognize royalties based on the success of its subsidiary, TRx
Pharma, in selling licensed products. Additionally, we are in active discussions with potential
partners regarding our product candidates, though some of our product candidates could take several
more years of development before they reach the stage of being partnerable with other companies on
terms that we believe would be acceptable. If we successfully consummate a partnering deal, we may
be entitled to license fees and milestone payments that we may recognize in 2007. Of course, any
such fees and payments will depend on successfully consummating a deal and achieving milestones
under such arrangements.
Recent
Accounting Pronouncements
See
Note 1, Summary of Significant Accounting Policies Recent
Accounting Pronouncements, in the Notes to Unaudited Condensed
Consolidated Financial Statements for a discussion of recent accounting
pronouncements and their effect, if any, on the Company.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are not subject to any meaningful market risk related to foreign currency exchange rates,
commodity prices or similar market risks. Substantially all of our expenses and capital purchasing
activities are transacted in U.S. dollars. We are sensitive to interest rate fluctuations. The
primary objective of our investing activities is to preserve principal while maximizing the income
we receive from our investments without significantly increasing the risk of loss. Some of the
investable securities permitted under our cash management policy may be subject to market risk for
changes in interest rates. To mitigate this risk, we maintain a portfolio of cash equivalent and
short-term investments in a variety of securities which may include investment grade commercial
paper, money market funds, government debt issued by the United States of America, state debt,
certificates of deposit and investment grade corporate debt. Presently, we are exposed to minimal
market risks associated with interest rate changes because of the relatively short maturities of
our investments and we do not expect interest rate fluctuations to materially affect the aggregate
value of our financial instruments. We manage our sensitivity to these risks by maintaining
investment grade short-term investments. Our cash management policy does not allow us to purchase
or hold derivative or commodity instruments or other financial instruments for trading purposes.
Additionally, our policy stipulates that we periodically monitor our investments for adverse
material holdings related to the underlying financial solvency of the issuer. As of March 31, 2007,
our investments consisted mostly of cash, commercial paper and U.S. government debt. Our results of
operations and financial condition would not be significantly impacted by either a 10% increase or
decrease in interest rates due mainly to the short-term nature of our investment portfolio. We have
not used derivative financial instruments in our investment portfolio. Additionally, we do not
invest in foreign currencies or other foreign investments.
Item 4. Controls and Procedures.
Evaluation of disclosure controls and procedures
As of the end of the period covered by this report, we conducted an evaluation, under the
supervision and with the participation of our principal executive officer and principal financial
officer, of the effectiveness of our disclosure controls and procedures (as defined in Rules
13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange
Act). Based on this evaluation, our principal executive officer and principal financial officer
concluded that our disclosure controls and procedures are effective to ensure that information
required to be disclosed by us in reports that we file or submit under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified in Securities and
Exchange Commission rules and forms and is accumulated and communicated to our management,
including our principal executive and principal financial officer, or persons performing similar
functions, as appropriate to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting identified in connection with
the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during
the period covered by this report that has materially affected, or is reasonably likely to
materially affect, our internal control over financial reporting.
17
Table of Contents
PART II. OTHER INFORMATION
Item 1. Legal Proceedings.
In the normal course of business, we may become subject to lawsuits and other claims and
proceedings. Such matters are subject to uncertainty and outcomes are often not predictable with
assurance. We are not aware of any pending or threatened material legal proceedings.
Item 1A. Risk Factors.
An investment in our securities involves a high degree of risk. You should consider carefully the
risks and uncertainties described under Item 1A of Part I of our Annual Report on Form 10-K for the
year ended December 31, 2006, which is incorporated by reference into this quarterly report. The
risks described in our Annual Report have not materially changed.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None
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.
An Exhibit Index has been attached as part of this quarterly report and is incorporated herein by
reference.
18
Table of Contents
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
ADVENTRX Pharmaceuticals, Inc. |
||||
Date: May 8, 2007 | By: | /s/ Evan M. Levine | ||
Evan M. Levine | ||||
Chief Executive Officer
(Principal Executive Officer) |
||||
Date: May 8, 2007 | By: | /s/ Gregory P. Hanson | ||
Gregory P. Hanson, CMA | ||||
Chief Financial Officer, Senior Vice President,
Finance, and Treasurer (Principal Financial and Accounting Officer) |
19
Table of Contents
Exhibit Index
Exhibit | Description | |
10.1*
|
Second Amendment to Option and License Agreement, effective as of January 25, 2007, between the registrant and the University of Southern California | |
10.2
|
Separation Agreement and Release of Claims, dated February 2, 2007, between the registrant and Robert A. Daniel | |
10.3
|
Consulting Agreement, dated February 2, 2007, between the registrant and Robert A. Daniel | |
31.1
|
Certification of chief executive officer pursuant to Rule 13a-14(a)/15d-14(a) | |
31.2
|
Certification of chief financial officer pursuant to Rule 13a-14(a)/15d-14(a) | |
32.1**
|
Certification of chief executive officer and chief financial officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
* | Indicates that confidential treatment has been requested for certain portions of this exhibit (as indicated by asterisks). We have filed separately with the Securities and Exchange Commission an unredacted copy of this exhibit. | |
** | 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. |
Exhibit 10.1
SECOND AMENDMENT TO OPTION AND LICENSE AGREEMENT
This Second Amendment to Option and License Agreement (this Amendment) is entered into
effective as of January 25, 2007 (the Effective Date) by and between Adventrx Pharmaceuticals,
Inc., a Delaware corporation formerly known as BioKeys Pharmaceuticals, Inc. and BioKeys, Inc. (the
Company), and the University of Southern California, a California nonprofit corporation (USC).
WHEREAS, the Company and USC are parties to that certain Option and License Agreement, dated
August 17, 2000, as amended pursuant to that certain Amendment to Option and License Agreement
between USC and the Company, dated April 21, 2003 (the Agreement);
NOW, THEREFORE, in consideration of the terms and conditions set forth below, the Company and
USC hereby agree as follows:
1. Field of Use. Section 2(c) of the Agreement is hereby amended and restated to read
in its entirety to read in full as follows:
FIELD OF USE shall mean diagnosis, treatment and/or prevention of viral
infections.
2. Patent Prosecution Expenses. Section 7(e) of the Agreement is hereby amended and
restated in its entirely to read in full as follows:
If the Licensee decides to terminate this Agreement pursuant to the second
sentence of Paragraph 16, Licensee shall reimburse the reasonable legal expenses
incurred by USC for up to one (1) month from the date written notification of
termination is sent by Licensee.
3. Termination. The third sentence of Section 16(a) of the Agreement is hereby
amended and restated in its entirety to read in full as follows:
Licensee may also terminate this Agreement at any time, for any reason, by
providing USC a thirty (30) day written notice and reimbursing the reasonable legal
expenses incurred by USC for up to one (1) month from the date written notification
of termination is sent by Licensee.
4. Termination. A new sentence shall be added at the end of Section 16(a) of the
Agreement as follows:
The foregoing notwithstanding, should Licensee fail to achieve the milestones set
forth in Section 26(b), USC shall have the option to terminate this Agreement only
by providing written notice of termination to Licensee within one (1) month of the
applicable milestone deadline.
5. Product Development. Section 26 of the Agreement is hereby amended to include
three sections: the existing paragraph shall be designated as 26(a), and a new 26 (b) and
26(c) shall be added as follows:
b. Licensee shall file an Investigational New Drug (IND) application with the US FDA
(or a foreign equivalent with an equivalent foreign authority in Canada, France, Germany,
Sweden, Switzerland or the United Kingdom (collectively, the European Countries)) for the
PRODUCT no later than ***. Licensee shall initiate at least one clinical trial for the
PRODUCT on or before ***. Licensee shall file a New Drug Application (NDA), abbreviated
NDA or any successor to such forms with the US FDA (or foreign equivalent of any of the
foregoing in one of the European Countries or via the EMEA Centralized Process) for the
PRODUCT on or before ***.
c. From time to time as a result of this Agreement, including in connection with the
reports and/or during the visits and presentations described in Section 26(a), the Licensee
may disclose confidential information relating to Licensees business. USC agrees (i) to
hold such information in strict confidence and to take reasonable measures to protect such
information, (ii) not to divulge such information or any information derived therefrom to
any third party and (iii) not to make any use whatsoever at any time of such information
other than to evaluate Licensees obligations under this Section 26. Anyone to whom USC
gives access to such information must have a legitimate need to know and be bound in
writing by confidentiality and non-use obligations at least as restrictive as those set
forth in this Section 26(c). These obligations will continue until such time as such
information is publicly known or generally available through no action or inaction of USC
or anyone to whom it gave access to such information.
6. Internal Reference. The Company and USC agree that any reference in the Agreement
to this Agreement (or other similar reference) will be a reference to the Agreement, as amended.
7. Conflicts. Except to the extent amended herein, the Agreement remains in full
force and effect.
[Signature page follows]
*** Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission.
IN WITNESS WHEREOF, the Company and USC have executed this Second Amendment to Option and
License Agreement in duplicate originals effective as of the Effective Date.
COMPANY: | ADVENTRX PHARMACEUTICALS, INC. | |||
By: | /s/ Evan Levine | |||
Name: | Evan Levine | |||
Title: | Chief Executive Officer | |||
USC: | UNIVERSITY OF SOUTHERN CALIFORNIA | |||
By: | /s/ Dennis F. Dougherty | |||
Name: | Dennis F. Dougherty | |||
Title: | Senior Vice President, Finance and CFO | |||
[COUNTERPART SIGNATURE PAGE TO SECOND AMENDMENT TO OPTION AND
LICENSE AGREEMENT]
LICENSE AGREEMENT]
Exhibit 10.2
SEPARATION AGREEMENT AND RELEASE OF CLAIMS
(initially provided to Mr. Daniel on January 22, 2007)
(provided to Mr. Daniel as amended on January 30, 2007)
(provided to Mr. Daniel as further amended on February 1, 2007)
(initially provided to Mr. Daniel on January 22, 2007)
(provided to Mr. Daniel as amended on January 30, 2007)
(provided to Mr. Daniel as further amended on February 1, 2007)
This Separation Agreement and Release of Claims (this Separation Agreement) is made by
and between ADVENTRX Pharmaceuticals, Inc. (the Company), a Delaware corporation, and Robert A.
Daniel (Mr. Daniel) (collectively, the Parties).
RECITALS
WHEREAS, the Parties have agreed to transition Mr. Daniels responsibilities and duties to the
Company in a considered and professional manner;
WHEREAS, Mr. Daniel will conclude his employment with the Company, as described herein;
WHEREAS, after the conclusion of Mr. Daniels employment with the Company, Mr. Daniel wishes
to serve as a consultant to the Company, and the Company wishes to retain Mr. Daniel as a
consultant;
WHEREAS, the Parties desire an amicable separation of employment and to resolve any and all
claims, disputes, issues, or matters that were asserted or could be asserted;
NOW THEREFORE, in consideration of the promises, covenants and agreements set forth herein,
and subject to the terms and conditions set forth below, the Parties desire to, and hereby do,
agree as follows:
1. Mr. Daniels employment with the Company will terminate effective February 15, 2007 (the
Termination Date);
2. The Company will retain Mr. Daniel, and Mr. Daniel agrees to provide, services as an
independent contractor on the terms provided in the independent contractor agreement attached
hereto as Exhibit A (including the Companys Confidential Information and Invention Assignment
Agreement referenced therein) (the Consulting Agreement). The Parties agree that, concurrent with
the signing of this Separation Agreement, they will sign the Consulting Agreement and that the
effectiveness of the Consulting Agreement will be concurrent with the effectiveness of the
termination of Mr. Daniels employment with the Company. For clarification, the Parties agree that
Mr. Daniel will remain in Continuous Service (as defined in the Companys 2005 Equity Incentive
Plan) to the Company for so long as the Consulting Agreement remains in effect but in no event
beyond March 30, 2007.
3. On the Termination Date, the Company will make available to Mr. Daniel his final paycheck
for wages and all earned and unused vacation. This payment is not dependent upon Mr. Daniel
signing this Separation Agreement. In addition, in exchange for Mr. Daniel agreeing to be bound by
the terms of this Separation Agreement and the Consulting Agreement and performing his obligations
hereunder and thereunder (including, without limitation, granting the release set forth in Section
4), the Company will provide Mr. Daniel with the following benefits to which he otherwise would not
be entitled:
3.1 Six (6) months of pay, payable in a lump sum on March 30, 2007, based on Mr. Daniels
current base salary, less all the required withholdings and taxes; provided however, that both (a)
Mr. Daniel has not terminated the Consulting Agreement prior to March 30, 2007 and (b) the Company
has not terminated the Consulting Agreement prior to March 30, 2007 as a result of Mr. Daniels
material breach of the Consulting Agreement (including the Companys Confidential Information and
Invention Agreement referenced therein).
3.2 If Mr. Daniel chooses to elect continuation of coverage under the federal law known
as COBRA, the Company will continue to pay Mr. Daniels medical, dental and vision premium through
September 30, 2007, unless he becomes eligible for coverage under another group insurance plan
before that date.
3.3 Mr. Daniel acknowledges and agrees that, (a) upon his receipt of the final paycheck
described in Section 3, the Company has paid all salary, wages, bonuses, commissions, vacation pay,
floating holiday pay and other benefits or compensation due Mr. Daniel from the Company and (b) but
for this Separation Agreement, Mr. Daniel is not entitled to the benefits set forth in Sections 3.1
or 3.2 and that, in the event Mr. Daniel fails to fully perform under this Separation Agreement or
the Consulting Agreement, the Company has no obligation to provide, or continue to provide, such
benefits.
4. Releases.
4.1 Mr. Daniel, for himself and his heirs, agents, assigns, executors, administrators,
representatives, successors and each of them, unconditionally, irrevocably and absolutely releases
and discharges the Company, and each of its current, former and future parents, subsidiaries,
divisions, partnerships, employee benefit plans and other related and affiliated entities of the
Company and their respective employees, officers, directors, agents, predecessors, successors,
fiduciaries, consultants, attorneys and assigns (collectively Released Parties), from all claims
related in any way to the transactions or occurrences between them to date, to the fullest extent
permitted by law, including, but not limited to, Mr. Daniels employment with the Company, the
termination of his employment, and all other losses, liabilities, claims, demands and causes of
action, known or unknown, suspected or unsuspected, arising directly or indirectly out of or in
any way connected with Mr. Daniels employment with the Company and the termination
2
of that
employment. This release is intended to have the broadest possible application
permitted by law and includes, but is not limited to, any tort, contract, common law,
constitutional or statutory claims and all claims for attorneys fees, costs and expenses.
Notwithstanding the foregoing, this release shall not serve as a waiver of Mr. Daniels rights to:
(i) vested benefits due to his employment with the Company, (ii) workers compensation or
unemployment benefits, (iii) statutorily-required indemnification under California Labor Code
Section 2802 or any comparable provisions of other states laws, or (iv) any other benefits or
claims that cannot be released as a matter of law.
4.2 The Company, and each of its current, former and future parents, subsidiaries, divisions,
partnerships, employee benefit plans and other related and affiliated entities of the Company and
their respective employees, officers, directors, agents, predecessors, successors, fiduciaries,
consultants, attorneys and assigns and each of them, unconditionally, irrevocably and absolutely
releases and discharges Mr. Daniel and his heirs, agents, assigns, executors, administrators,
representatives, successors (collectively, Releasees) from all claims related in any way to the
transactions or occurrences between them to date, to the fullest extent permitted by law, including
but not limited to, Mr. Daniels employment with the Company, the termination of his employment,
and all other losses, liabilities, claims, demands and causes of action, known or unknown,
suspected or unsuspected, arising directly or indirectly out of or in any way connected with Mr.
Daniels employment with the Company and the termination of that employment. This release is
intended to have the broadest possible application permitted by law and includes, but is not
limited to, any tort, contract, common law, constitutional or statutory claims and all claims for
attorneys fees, costs and expenses.
4.3 Each of the Parties declares and represents that it intends this Separation Agreement to
be complete and not subject to any claim of mistake, and that the release herein expresses a full
and complete release and, regardless of the adequacy or inadequacy of the consideration, the
Parties intend the releases to be final and complete. The Parties execute this Separation
Agreement with the full knowledge that the releases contained in it covers all possible claims
against the Released Parties and the Releasees, as applicable, to the fullest extent permitted by
law.
5. Acknowledgement of Understanding. Each of the Parties acknowledges that it may
discover facts or law different from, or in addition to, the facts or law that it knows or believes
to be true with respect to the claims released in this Separation Agreement and agrees,
nonetheless, that this Separation Agreement and the releases contained in it shall be and remain
effective in all respects notwithstanding such different or additional facts or the discovery of
them. Each of the Parties expressly acknowledges and agrees that its rights under Section 1542 of
the California Civil Code and any comparable provisions of other states and federal law are
expressly waived. That section provides:
3
A general release does not extend to claims which the creditor does not know or
suspect to exist in his or her favor at the time of executing the
release, which if known by him or her must have materially affected his or her
settlement with the debtor.
Each of the Parties expressly acknowledges, agrees and understands that the general release
give in Section 4 applies to all unknown, unsuspected and unanticipated claims, liabilities and
causes of action that it may have against any of the Released Parties or the Releasees, as
applicable.
6. Pursuit of Released Claims. Each of the Parties represents that, as of the date of
this Separation Agreement, it has not filed any lawsuits, charges, complaints, petitions, claims or
other accusatory pleadings against any of the Released Parties or Releasees, as applicable, in any
court or with any governmental agency. Each of the Parties further agrees that, to the fullest
extent permitted by law, it will not prosecute, nor allow to be prosecuted on his behalf, in any
court, whether state or federal, any claim or demand of any type related to the matters released
herein, it being the intention of each of the Parties that with the execution of this Separation
Agreement, the Released Parties and the Releasees will each be absolutely, unconditionally and
forever discharged of and from all obligations to or on behalf of the Releasees and the Released
Parties, respectively, related in any way to the matters discharged herein. Each of the Parties
further represents that it has not assigned any claim it may have against any of the Released
Parties or Releasees, as applicable, to any other person or entity. Nothing in this Separation
Agreement limits either of the Parties right to file a charge or complaint with any state or
federal agency or to participate or cooperate in such a matter, but each of the Parties
acknowledges that it is not entitled to any other monies other than those payments described in
this Separation Agreement.
7. Continuing Obligations. Mr. Daniel represents that, on or before the Termination
Date, he will return to the Company all Company documents, information and property, including
(without limitation) files, records, computer access codes and instruction manuals, as well as any
of the Companys assets or equipment that Mr. Daniel has in his possession or are under his
control, unless and to the extent the Company determines such property is necessary for Mr. Daniel
to perform under the Consulting Agreement (in which case the use and return of such property will
be governed by the Consulting Agreement). Subject to the foregoing, Mr. Daniel further agrees not
to keep any copies of any Company documents or information. In addition to the terms and
conditions of the Consulting Agreement, Mr. Daniel acknowledges and agrees that he will continue to
be bound by (a) the Confidential Information, Non-Solicitation and Invention Assignment Agreement
for Employees entered into between the Company and Mr. Daniel (the Company Agreement), (b) the
Code of Business Conduct and Ethics for Employees, Executive Officers and Directors executed by
Employee (the Code of Ethics) and (c) the Policies and Procedure Manual executed by Employee (the
Manual), copies of all of which have been provided to Employee.
4
8. Expense Reimbursement. By signing this Separation Agreement, Mr. Daniel agrees to
submit all outstanding reimbursements he incurred as an employee of the Company to the Company on
or before the Termination Date.
9. Nondisparagement. Mr. Daniel will not make any voluntary statements, written or
verbal, or cause or encourage others to make any such statements that defame, disparage or in any
way criticize the Companys business reputation, practices or conduct. The Company will not make
any voluntary statements, written or verbal, or cause or encourage others to make any such
statements that defame, disparage or in any way criticize Mr. Daniel, or his business reputation,
practices or conduct. The foregoing notwithstanding, the Parties may respond accurately and fully
to any questions, inquiry or request for information when required to do so by legal process.
10. Arbitration of Disputes and Enforcement of Agreement.
10.1 Mr. Daniel and the Company agree to resolve any claims they may have against each other
or that Mr. Daniel has with any of the other Released Parties through final and binding
arbitration. This agreement to arbitrate applies to any and all disputes about the validity,
interpretation, or effect of this Separation Agreement or alleged violations of it and whether a
particular claim is covered by this Separation Agreement. Except as provided in Section 10.2 and
Section 10.3, arbitration shall be the exclusive remedy for any such claim or dispute, and the
Parties expressly waive their rights to a jury trial on any such claim or dispute. However, either
party may bring an action in court to compel arbitration under this Separation Agreement or to
enforce an arbitration award. The Parties agree that a neutral arbitrator from the American
Arbitration Association will administer any such arbitration(s) pursuant to its National Rules for
the Resolution of Employment Disputes. The arbitrator shall issue a written decision with the
essential findings and conclusions on which the decision is based.
10.2 The requirement to arbitrate disputes shall not preclude either of the Parties from
filing a charge or claim with a state or federal government agency. However, Mr. Daniel
acknowledges that he is not entitled to any other monies other than those payments described in
this Separation Agreement.
10.3 Nothing in this Section 10 shall preclude either Party from seeking interim or
provisional relief in the form of a temporary restraining order, preliminary injunction, or other
interim relief concerning a dispute prior to or during an arbitration pursuant to this Section 10
necessary to protect the interests of such Party.
5
11. Older Workers Benefit Protection Act. This Separation Agreement is intended to
satisfy the requirements of the Older Workers Benefit Protection Act, 29 U.S.C. sec. 626(f). The
following general provisions, along with the other provisions of this Separation Agreement, are
agreed to for this purpose:
11.1 Mr. Daniel acknowledges and agrees that he has read and understands the terms of this
Separation Agreement.
11.2 Mr. Daniel acknowledges that this Separation Agreement advises him in writing that he may
consult with an attorney before executing this Separation Agreement, and that he has obtained and
considered such legal counsel as he deems necessary, such that he is entering into this Separation
Agreement freely, knowingly and voluntarily.
11.3 Mr. Daniel acknowledges that he has been given at least twenty-one (21) days in which to
consider whether or not to enter into this Separation Agreement. Mr. Daniel understands that, at
his option, he may elect not to use the full twenty-one (21) day period.
11.4 Mr. Daniel shall have seven (7) full calendar days after signing this Separation
Agreement to revoke this Separation Agreement. This Separation Agreement will not become effective
until the expiration of the revocation period. Mr. Daniels revocation of this Separation
Agreement must be in writing and received by Patrick Keran, General Counsel, no later than Noon on
the eighth day in order to be effective. If Mr. Daniel does not revoke acceptance within the seven
(7) day period, this Separation Agreement will become fully effective and enforceable on the eighth
day after the Separation Agreement is signed (the Effective Date).
11.5 Mr. Daniel does not waive or release any rights or claims that he may have under the Age
Discrimination in Employment Act that arise after the execution of this Separation Agreement. Mr.
Daniel is not waiving his right to file a complaint or charge with the EEOC (including a challenge
to the validity of this Separation Agreement) or participate in any investigation or proceeding
conducted by the EEOC.
6
12. Confidentiality. Mr. Daniel agrees to keep this Separation Agreement confidential
and not to reveal its contents or terms to anyone except Mr. Daniels lawyer, spouse and/or
financial consultant.
13. Miscellaneous. This Separation Agreement is intended to be the entire agreement
between the Parties and supersedes and cancels any and all other prior agreements, written or oral,
between the Parties regarding this subject matter, except the Consulting Agreement, the Company
Agreement, the Code of Ethics and the Manual, each of which will remain in full force and effect
until it terminates, expires or no longer applies pursuant to its terms or as set forth herein.
Mr. Daniel represents that, in executing this Separation Agreement, he is not relying and has not
relied on any representation or statement made by any of the Released Parties or any of their
respective agents, attorneys or representatives with regard to the subject matter, basis or effect
of this Separation Agreement, or otherwise, other than those specifically set forth in this
Separation Agreement. This Separation Agreement may not be modified except by a writing signed by
both Mr. Daniel and an authorized officer of the Company and will be binding upon Mr. Daniel and
his heirs, agents, assigns, executors, administrators, representatives, successors. In the event
any provision of this Separation Agreement is found to be unenforceable by an arbitrator or a court
of competent jurisdiction, the provision will be deemed modified to the extent necessary to allow
enforceability of the provision as so limited, it being intended that the Company will receive the
benefits contemplated herein to the fullest extent permitted by law and all other provisions will
remain fully enforceable. This Agreement shall be governed by the laws of the State of California.
14. Counterparts. This Separation Agreement may be executed by facsimile or facsimile
signature, and in separate counterparts, each of which shall be deemed an original but all of
which, when taken together, shall constitute one and the same instrument.
IN WITNESS WHEREOF, I have executed this Agreement and have acknowledged that I executed the
same as my own free act and deed.
Date
|
February 2, 2007 | /s/ Robert A. Daniel | ||
Robert A. Daniel | ||||
Date
|
Feb 2, 2007 | /s/ Gregory P. Hanson | ||
ADVENTRX Pharmaceuticals, Inc. |
7
EXHIBIT A
CONSULTING AGREEMENT
8
Exhibit 10.3
ADVENTRX PHARMACEUTICALS, INC.
CONSULTING AGREEMENT
This Consulting Agreement (this Agreement) is dated February 2, 2007 but will become
effective (the Effective Date) as of and concurrent with the termination of the
employment relationship of Robert A. Daniel , an individual resident of the State of California
(Consultant), with ADVENTRX Pharmaceuticals, Inc., a Delaware corporation (the
Company).
1. Consulting Relationship. During the term of this Agreement, Consultant will
provide consulting services (the Services) to the Company as described on Exhibit
A attached to this Agreement. Consultant represents that Consultant is duly licensed (as
applicable) and has the qualifications, the experience and the ability to properly perform the
Services. Consultant shall use Consultants best efforts to perform the Services such that the
results are satisfactory to the Company and in conformance with the Code of Professional Ethics of
the AICPAA. Consultant shall provide Services only as requested by the Company.
2. Fees. As consideration for the Services to be provided by Consultant and other
obligations, the Company shall pay to Consultant the amounts specified in Exhibit B
attached to this Agreement at the times specified therein.
3. Expenses. Consultant shall not be authorized to incur on behalf of the Company any
expenses.
4. Term and Termination. Consultant shall serve as a consultant to the Company for a
period commencing on the Effective Date and terminating upon written notice of termination from the
Company to Consultant or from Consultant to the Company; provided, however, that the
Company may not terminate this Agreement prior to March 30, 2007 unless Consultant is in material
breach of this Agreement, the Confidentiality Agreement (as defined below) or that certain
Separation Agreement and Release of Claims by and between the Company and Consultant and initially
provided to Consultant on January 22, 2007 (and provided to Consultant as amended on January 30,
2007 and as further amended on February 1, 2007).
5. Independent Contractor. Consultants relationship with the Company will be that of
an independent contractor and not that of an employee.
(a) Method of Provision of Services. Consultant shall be solely responsible for
determining the method, details and means of performing the Services. Consultant may not employ or
engage the service of any third parties to perform the Services required by this Agreement.
(b) No Authority to Bind Company. Neither Consultant, nor any partner, agent or
employee of Consultant, has authority to enter into contracts that bind the Company or create
obligations on the part of the Company without the prior written authorization of the Company.
(c) No Benefits. Consultant acknowledges and agrees that Consultant (or Consultants
employees, if Consultant is an entity) will not be eligible for any Company employee benefits and,
to the extent Consultant (or Consultants employees, if Consultant is an entity) otherwise would be
eligible for any Company employee benefits but for the express terms of this Agreement, Consultant
(on behalf of itself and its employees) hereby expressly declines to participate in such Company
employee benefits.
(d) Withholding; Indemnification. Consultant shall have full responsibility for
applicable withholding taxes for all compensation paid to Consultant, its partners, agents or its
employees under this Agreement, and for compliance with all applicable labor and employment
requirements with respect to Consultants self-employment, sole proprietorship or other form of
business organization, and Consultants partners, agents and employees, including state workers
compensation insurance coverage requirements and any US immigration visa requirements. Consultant
agrees to indemnify, defend and hold the Company harmless from any liability for, or assessment of,
any claims or penalties with respect to such withholding taxes, labor or employment requirements,
including any liability for, or assessment of, withholding taxes imposed on the Company by the
relevant taxing authorities with respect to any compensation paid to Consultant or Consultants
partners, agents or its employees.
6. Supervision of Consultants Services. All of the services to be performed by
Consultant, including but not limited to the Services, will be as agreed between Consultant and the
Companys chief financial officer. Consultant will be required to report to the Companys chief
financial officer concerning the Services performed under this Agreement. The nature and frequency
of these reports will be left to the discretion of the Companys chief financial officer.
7. Confidentiality Agreement. Consultant shall sign, or has signed, the Companys
current Confidential Information and Invention Assignment Agreement (the Confidentiality
Agreement) on or before the Effective Date.
8. Conflicts with this Agreement. Consultant represents and warrants that neither
Consultant nor any of Consultants partners, employees or agents is under any pre-existing
obligation in conflict or in any way inconsistent with the provisions of this Agreement. Consultant
represents and warrants that Consultants performance of all the terms of this Agreement will not
breach any agreement to keep in confidence proprietary information acquired by Consultant in
confidence or in trust prior to commencement of this Agreement. Consultant warrants that Consultant
has the right to disclose and/or or use all ideas, processes, techniques and other information, if
any, which Consultant has gained from third parties, and which Consultant discloses to the Company
or uses in the course of performance of this Agreement, without liability to such third parties.
Notwithstanding the foregoing, Consultant agrees that Consultant shall not bundle with or
incorporate into any deliveries provided to the Company herewith any third party products, ideas,
processes, or other techniques, without the express, written prior approval of the Company.
Consultant represents and warrants that Consultant has not granted and will not grant any rights or
licenses to any intellectual property or technology that would conflict with Consultants
obligations under this Agreement. Consultant will not knowingly infringe upon any copyright,
patent, trade secret or other property right of
-2-
any former client, employer or third party in the
performance of the Services required by this Agreement.
9. Miscellaneous.
(a) Amendments and Waivers. Any term of this Agreement may be amended or waived only
with the written consent of the parties.
(b) Sole Agreement. This Agreement, including the Exhibits hereto, constitutes the
sole agreement of the parties and supersedes all oral negotiations and prior writings with respect
to the subject matter hereof. The foregoing notwithstanding, the Company and Consultant
acknowledge that this Agreement is entered into in connection with that certain Severance Agreement
and Release of All Claims, dated of even date herewith (the Severance Agreement), and that this
Agreement has no effect on the Severance Agreement or any of the documents or other agreements
referenced therein or executed in connection therewith.
(c) Notices. Any notice required or permitted by this Agreement shall be in writing
and shall be deemed sufficient upon receipt, when delivered personally or by courier, overnight
delivery service or confirmed facsimile, 48 hours after being deposited in the regular mail as
certified or registered mail (airmail if sent internationally) with postage prepaid, if such notice
is addressed to the party to be notified at such partys address or facsimile number as set forth
below, or as subsequently modified by written notice.
(d) Choice of Law. The validity, interpretation, construction and performance of this
Agreement shall be governed by the laws of the State of California as applied to agreements among
California residents entered into and to be performed entirely within California.
(e) Severability. If one or more provisions of this Agreement are held to be
unenforceable under applicable law, the parties agree to renegotiate such provision in good faith.
In the event that the parties cannot reach a mutually agreeable and enforceable replacement for
such provision, then (i) such provision shall be excluded from this Agreement, (ii) the balance of
the Agreement shall be interpreted as if such provision were so excluded and (iii) the balance of
the Agreement shall be enforceable in accordance with its terms.
(f) Counterparts. This Agreement may be executed in counterparts, each of which shall
be deemed an original, but all of which together will constitute one and the same instrument.
(g) Arbitration. Any dispute or claim arising out of or in connection with any
provision of this Agreement will be finally settled by binding arbitration in San Diego County,
California, in accordance with the rules of the American Arbitration Association by one arbitrator
appointed in accordance with said rules. The arbitrator shall apply California law, as applied to
agreements among California residents entered into and to be performed entirely within California,
to the resolution of any dispute. Judgment on the award rendered by the arbitrator may be entered
in any court having jurisdiction thereof. Notwithstanding the foregoing, the parties may apply to
any court of competent jurisdiction for preliminary or interim
-3-
equitable relief, or to compel
arbitration in accordance with this paragraph, without breach of this arbitration provision. This
Section 10(g) shall not apply to the Confidentiality Agreement.
(h) Advice of Counsel. EACH PARTY ACKNOWLEDGES THAT, IN EXECUTING THIS AGREEMENT,
SUCH PARTY HAS HAD THE OPPORTUNITY TO SEEK THE ADVICE OF INDEPENDENT LEGAL COUNSEL, AND HAS READ
AND UNDERSTOOD ALL OF THE TERMS AND PROVISIONS OF THIS AGREEMENT. THIS AGREEMENT SHALL NOT BE
CONSTRUED AGAINST ANY PARTY BY REASON OF THE DRAFTING OR PREPARATION HEREOF.
[Signature Page Follows]
-4-
The parties have executed this Agreement on the respective dates set forth below.
ADVENTRX PHARMACEUTICALS, INC. | ||||
By: | /s/ Gregory P. Hanson | |||
Title: | SVP & CFO | |||
Address: | 6725 Mesa Ridge Road, Suite 100 | |||
San Diego, CA 92121 | ||||
ROBERT A. DANIEL | ||||
/s/ Robert A. Daniel | ||||
Signature | ||||
Address: | 5639 Amaga Dr., #309 | |||
La Mesa, CA 91942 |
EXHIBIT A
DESCRIPTION OF CONSULTING SERVICES
Description of Services | Schedule/Deadline | |
Consultant will:
|
Not applicable |
| Make himself available during normal business hours at the Companys offices to perform consulting services as requested by the Company. | |||
| Respond to inquiries of the Companys personnel regarding financial and accounting matters, and such other matters related to the Company regarding which Consultant has knowledge. | |||
| Make himself available and use his best efforts in the transition of his former duties to designated representatives or employees of the Company. Such efforts include, but are not limited to, providing corporate records, files and other materials. | |||
| Provide advice and assistance regarding special projects, conference appearances or any other matter consistent with Consultants background, skills and experience. |
EXHIBIT B
COMPENSATION
From the Effective Date through March 30, 2007, provided this Agreement has not been
terminated, the Company will compensate Consultant as follows (pro-rated for any portion of a
calendar month during which this Agreement is effective based on a 30-day month):
On February 28, 2007, an amount equal to $6,751.57
On March 15, 2007, an amount equal to $6,751.57
On March 30, 2007, an amount equal to $6,751.57
Payment will be due within 5 days of each date set forth above or, if this Agreement is
terminated prior to March 30, 2007, within 5 days of the date of termination.
Following March 30, 2007 and in the event this Agreement is not terminated, the Company and
Consultant will mutually agree in writing upon the compensation to be paid by the Company to
Consultant for on-going services, if any, to be provided by Consultant to the Company. For
clarification, following March 30, 2007 (a) the Company will have no obligation whatsoever to
compensate Consultant until such time as such compensation is agreed upon in writing, if at all
and (b) Consultant will have no obligation whatsoever to provide services to the Company until
such time as such compensation is agreed upon in writing, if at all.
Exhibit 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Evan M. Levine, certify that:
1. | I have reviewed this Quarterly Report on Form 10-Q of ADVENTRX Pharmaceuticals, Inc.; | |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; | |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | |
4. | The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)), for the registrant and have: |
a. | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | ||
b. | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | ||
c. | Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | ||
d. | Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. | The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of registrants board of directors (or persons performing the equivalent functions): |
a. | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and | ||
b. | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
Date: May 8, 2007
/s/ Evan M. Levine | ||||
Evan M. Levine | ||||
Chief Executive Officer
(Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Gregory P. Hanson, certify that:
1. | I have reviewed this Quarterly Report on Form 10-Q of ADVENTRX Pharmaceuticals, Inc.; | |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; | |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | |
4. | The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)), for the registrant and have: |
a. | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | ||
b. | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | ||
c. | Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | ||
d. | Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. | The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of registrants board of directors (or persons performing the equivalent functions): |
a. | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and | ||
b. | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
Date: May 8, 2007
/s/ Gregory P. Hanson | ||||
Gregory P. Hanson, CMA | ||||
Senior Vice President, Chief Financial Officer
(Principal Financial and Accounting Officer) |
Exhibit 32.1
Certification of Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C.
Section 1350, As Adopted Pursuant To
Section 906 of The Sarbanes-Oxley Act of 2002
Section 1350, As Adopted Pursuant To
Section 906 of The Sarbanes-Oxley Act of 2002
In connection with the Quarterly Report of ADVENTRX Pharmaceuticals, Inc. (the Company) on Form
10-Q for the quarter ended March 31, 2007, as filed with the Securities and Exchange Commission on
the date hereof (the Report), I, Evan M. Levine, Chief Executive Officer of the Company, certify
for the purposes of section 1350 of chapter 63 of title 18 of the United States Code that, to the
best of my knowledge,
(i) the Report fully complies with the requirements of section 13(a) of the Securities
Exchange Act of 1934, and
(ii) the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
Date: May 8, 2007
/s/ Evan M. Levine | ||||
Evan M. Levine | ||||
Chief Executive Officer | ||||
In connection with the Quarterly Report of ADVENTRX Pharmaceuticals, Inc. (the Company) on Form
10-Q for the quarter ended March 31, 2007, as filed with the Securities and Exchange Commission on
the date hereof (the Report), I, Gregory P. Hanson, Senior Vice President, Chief Financial
Officer of the Company, certify for the purposes of section 1350 of chapter 63 of title 18 of the
United States Code that, to the best of my knowledge,
(i) the fully complies with the requirements of section 13(a) of the Securities Exchange
Act of 1934, and
(ii) the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
Date: May 8, 2007
/s/ Gregory P. Hanson | ||||
Gregory P. Hanson, CMA | ||||
Senior Vice President, Chief Financial Officer | ||||