þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware (State or other jurisdiction of incorporation or organization) |
84-1318182 (I.R.S. Employer Identification No.) |
|
6725 Mesa Ridge Road, Suite 100, San Diego, CA (Address of principal executive offices) |
92121 (Zip Code) |
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o | Smaller reporting company þ |
Page | ||||||||
1 | ||||||||
1 | ||||||||
1 | ||||||||
2 | ||||||||
3 | ||||||||
4 | ||||||||
11 | ||||||||
20 | ||||||||
20 | ||||||||
21 | ||||||||
21 | ||||||||
21 | ||||||||
21 | ||||||||
21 | ||||||||
21 | ||||||||
21 | ||||||||
21 | ||||||||
22 | ||||||||
Exhibit 31.1 | ||||||||
Exhibit 31.2 | ||||||||
Exhibit 32.1 |
i
Item 1. | Financial Statements |
June 30, | December 31, | |||||||
2010 | 2009 | |||||||
(Unaudited) | ||||||||
Assets |
||||||||
Current assets: |
||||||||
Cash |
$ | 31,159,630 | $ | 8,667,404 | ||||
Restricted cash |
632,789 | | ||||||
Interest and other receivables |
10,934 | 14,841 | ||||||
Prepaid expenses |
595,524 | 290,249 | ||||||
Total current assets |
32,398,877 | 8,972,494 | ||||||
Property and equipment, net |
39,342 | 44,210 | ||||||
Other assets |
2,221 | 10,513 | ||||||
Total assets |
$ | 32,440,440 | $ | 9,027,217 | ||||
Liabilities and Stockholders Equity |
||||||||
Current liabilities |
||||||||
Accounts payable |
$ | 414,080 | $ | 385,358 | ||||
Accrued liabilities |
796,420 | 1,379,010 | ||||||
Preferred stock dividends obligation |
632,789 | | ||||||
Accrued compensation and payroll taxes |
117,372 | 589,319 | ||||||
Total current liabilities |
1,960,661 | 2,353,687 | ||||||
Stockholders equity: |
||||||||
Convertible Preferred Stock, Series A through E, $0.001 par
value, 34,559 shares authorized; 34,559 shares issued and 0
shares outstanding as of June 30, 2010 and December 31, 2009 |
| | ||||||
2.19446320054018% Series F Convertible Preferred Stock, $0.001
par value, 19,217.13 shares authorized; 19,217.13 shares issued
and 2,883.57 shares outstanding as of June 30, 2010 and 0
shares issued and outstanding as of December 31, 2009 |
2,471,304 | | ||||||
Common stock, $0.001 par value; 500,000,000 shares authorized;
14,701,216 and 8,211,410 shares issued and outstanding at June
30, 2010 and December 31, 2009, respectively |
14,701 | 8,211 | ||||||
Additional paid-in capital |
179,994,489 | 148,703,722 | ||||||
Deficit accumulated during the development stage |
(152,000,715 | ) | (142,038,403 | ) | ||||
Total stockholders equity |
30,479,779 | 6,673,530 | ||||||
Total liabilities and stockholders equity |
$ | 32,440,440 | $ | 9,027,217 | ||||
1
Inception | ||||||||||||||||||||
(June 12, 1996) | ||||||||||||||||||||
Three months ended June 30, | Six months ended June 30, | through | ||||||||||||||||||
2010 | 2009 | 2010 | 2009 | June 30, 2010 | ||||||||||||||||
Licensing revenue |
$ | | $ | | $ | | $ | 300,000 | $ | 1,300,000 | ||||||||||
Net sales |
| | | | 174,830 | |||||||||||||||
Grant revenue |
| | | | 129,733 | |||||||||||||||
Total net revenue |
| | | 300,000 | 1,604,563 | |||||||||||||||
Cost of sales |
| | | | 51,094 | |||||||||||||||
Gross margin |
| | | 300,000 | 1,553,469 | |||||||||||||||
Operating expenses: |
||||||||||||||||||||
Research and development |
633,766 | 1,454,896 | 1,873,095 | 3,102,197 | 70,395,300 | |||||||||||||||
Selling, general and administrative |
1,303,217 | 1,071,754 | 2,477,893 | 2,850,994 | 50,445,403 | |||||||||||||||
Depreciation and amortization |
5,767 | 25,835 | 11,647 | 58,081 | 10,889,445 | |||||||||||||||
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 |
1,942,750 | 2,552,485 | 4,362,635 | 6,011,272 | 148,033,344 | |||||||||||||||
Loss from operations |
(1,942,750 | ) | (2,552,485 | ) | (4,362,635 | ) | (5,711,272 | ) | (146,479,875 | ) | ||||||||||
Loss on fair value of warrants |
| | | | (12,239,688 | ) | ||||||||||||||
Interest income |
23,308 | 338 | 41,748 | 2,392 | 4,630,936 | |||||||||||||||
Interest expense |
| | (1,629 | ) | | (180,719 | ) | |||||||||||||
Other income (expense) |
| (43,394 | ) | | (43,672 | ) | 65,845 | |||||||||||||
Loss before cumulative effect of change in
accounting principle |
(1,919,442 | ) | (2,595,541 | ) | (4,322,516 | ) | (5,752,552 | ) | (154,203,501 | ) | ||||||||||
Cumulative effect of change in accounting
principle |
| | | | (25,821 | ) | ||||||||||||||
Net loss |
(1,919,442 | ) | (2,595,541 | ) | (4,322,516 | ) | (5,752,552 | ) | (154,229,322 | ) | ||||||||||
Preferred stock dividends |
| | | | (621,240 | ) | ||||||||||||||
Deemed dividends on preferred stock |
(3,124,876 | ) | (1,232,415 | ) | (5,639,796 | ) | (1,232,415 | ) | (10,506,683 | ) | ||||||||||
Net loss applicable to common stock |
$ | (5,044,318 | ) | $ | (3,827,956 | ) | $ | (9,962,312 | ) | $ | (6,984,967 | ) | $ | (165,357,245 | ) | |||||
Net loss per common share basic and diluted |
$ | (0.39 | ) | $ | (1.02 | ) | $ | (0.86 | ) | $ | (1.90 | ) | ||||||||
Weighted average shares basic and diluted |
12,886,826 | 3,735,572 | 11,522,885 | 3,673,526 | ||||||||||||||||
2
Inception | ||||||||||||
(June 12, 1996) | ||||||||||||
Six months ended June 30, | through | |||||||||||
2010 | 2009 | June 30, 2010 | ||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (4,322,516 | ) | $ | (5,752,552 | ) | $ | (154,229,322 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
Depreciation and amortization |
11,647 | 58,081 | 10,439,445 | |||||||||
Loss on disposals of fixed assets |
| 52,003 | 55,516 | |||||||||
Loss on fair value of warrants |
| | 12,239,688 | |||||||||
Expenses related to employee stock options and restricted stock issued |
451,974 | 305,179 | 8,889,973 | |||||||||
Expense related to stock options issued to non-employees |
| | 204,664 | |||||||||
Expenses paid by issuance of common stock |
| | 1,341,372 | |||||||||
Expenses paid by issuance of warrants |
| | 573,357 | |||||||||
Expenses paid by issuance of preferred stock |
| | 142,501 | |||||||||
Expenses related to stock warrants issued |
| | 612,000 | |||||||||
Accretion of discount |
| | (1,604,494 | ) | ||||||||
Amortization of debt discount |
| | 450,000 | |||||||||
Forgiveness of employee receivable |
| | 30,036 | |||||||||
Impairment loss write-off of goodwill |
| | 5,702,130 | |||||||||
Equity in loss of investee |
| | 178,936 | |||||||||
In-process research and development |
| | 10,422,130 | |||||||||
Write-off of license agreement |
| | 152,866 | |||||||||
Write-off of assets available-for-sale |
| | 108,000 | |||||||||
Cumulative effect of change in accounting principle |
| | 25,821 | |||||||||
Changes in assets and liabilities, net of effect of acquisitions: |
||||||||||||
(Increase) decrease in prepaid expenses and other assets |
(293,076 | ) | (12,182 | ) | (856,048 | ) | ||||||
Increase (decrease) in accounts payable and accrued liabilities |
(1,025,815 | ) | (843,212 | ) | 1,504,580 | |||||||
Net cash used in operating activities |
(5,177,786 | ) | (6,192,683 | ) | (103,616,849 | ) | ||||||
Cash flows from investing activities: |
||||||||||||
Purchases of short-term investments |
| | (111,183,884 | ) | ||||||||
Proceeds from sales and maturities of short-term investments |
| | 112,788,378 | |||||||||
Purchases of property and equipment |
(6,780 | ) | | (1,037,134 | ) | |||||||
Proceeds from sale of property and equipment |
| 14,049 | 49,906 | |||||||||
Purchase of certificate of deposit |
| | (1,016,330 | ) | ||||||||
Maturity of certificate of deposit |
| | 1,016,330 | |||||||||
Payment on obligation under license agreement |
| | (106,250 | ) | ||||||||
Cash acquired from acquisitions, net of cash paid |
| | 32,395 | |||||||||
Issuance of note receivable related party |
| | (35,000 | ) | ||||||||
Payments on note receivable |
| | 405,993 | |||||||||
Advance to investee |
| | (90,475 | ) | ||||||||
Cash transferred in rescission of acquisition |
| | (19,475 | ) | ||||||||
Cash received in rescission of acquisition |
| | 230,000 | |||||||||
Net cash provided by (used in) investing activities |
(6,780 | ) | 14,049 | 1,034,454 | ||||||||
Cash flows from financing activities: |
||||||||||||
Proceeds from sale of preferred stock |
30,453,227 | 1,993,000 | 44,474,720 | |||||||||
Proceeds of restricted cash for preferred stock dividends |
632,789 | | 632,789 | |||||||||
Proceeds from sale of common stock |
| | 84,151,342 | |||||||||
Proceeds from exercise of stock options |
| | 712,367 | |||||||||
Proceeds from sale or exercise of warrants |
317,444 | | 14,714,258 | |||||||||
Payment to escrow for preferred stock dividends obligation |
(632,789 | ) | | (632,789 | ) | |||||||
Repurchase of warrants |
| | (55,279 | ) | ||||||||
Payments for financing and offering costs |
(3,093,733 | ) | (245,043 | ) | (10,994,046 | ) | ||||||
Payments on notes payable and long-term debt |
| | (605,909 | ) | ||||||||
Proceeds from issuance of notes payable and detachable warrants |
| | 1,344,718 | |||||||||
Cash paid in lieu for reverse stock split |
(146 | ) | | (146 | ) | |||||||
Net cash provided by financing activities |
27,676,792 | 1,747,957 | 133,742,025 | |||||||||
Net increase (decrease) in cash |
22,492,226 | (4,430,677 | ) | 31,159,630 | ||||||||
Cash at beginning of period |
8,667,404 | 9,849,904 | | |||||||||
Cash at end of period |
$ | 31,159,630 | $ | 5,419,227 | $ | 31,159,630 | ||||||
3
1. | Basis of Presentation |
ADVENTRX Pharmaceuticals, Inc., a Delaware corporation (ADVENTRX, we, our or the
Company), prepared the unaudited interim condensed consolidated financial statements included
in this report in accordance with accounting principles generally accepted in the United States
of America (U.S. GAAP) for interim financial information and with the instructions of the
Securities and Exchange Commission (SEC). Accordingly, they do not include all of the
information and disclosures required by U.S. GAAP for annual audited financial statements and
should be read in conjunction with our audited consolidated financial statements and related
notes for the year ended December 31, 2009 included in our Annual Report on Form 10-K filed with
the SEC on March 18, 2010 (2009 Annual Report). The condensed consolidated balance sheet as of
December 31, 2009 included in this report has been derived from the audited consolidated
financial statements included in the 2009 Annual Report. In the opinion of management, these
consolidated financial statements include all adjustments (consisting of normal recurring
adjustments) necessary for a fair presentation of the financial position, results of operations
and cash flows for the periods presented. The results of operations for the interim periods
shown in this report are not necessarily indicative of results expected for the full year. |
The condensed consolidated financial statements include the accounts of the Company and its
wholly-owned subsidiaries, SD Pharmaceuticals, Inc. and ADVENTRX (Europe) Ltd. up until its
dissolution. We dissolved ADVENTRX (Europe) Ltd. in December 2009. All intercompany accounts
and transactions have been eliminated in consolidation. |
On April 23, 2010, the Company effected a 1-for-25 reverse split of its common stock, which was
authorized by its stockholders at a special meeting held in August 2009. All common stock share
and per share information in the condensed consolidated financial statements and notes thereto
included in this report have been restated to reflect retrospective application of the reverse
stock split for all periods presented ending or as of a date prior to April 23, 2010, except for
par value per share and the number of authorized shares, which were not affected by the reverse
stock split. |
2. | Use of Estimates |
The preparation of financial statements in conformity with U.S. GAAP requires management to make
estimates and assumptions that affect the amounts reported in the consolidated financial
statements and accompanying notes. Actual results could differ from those estimates. |
3. | Share-Based Compensation Expense |
Estimated share-based compensation expense related to equity awards granted to our employees and
non-employee directors for the three and six months ended June 30, 2010 and 2009 was as follows: |
Three months ended June 30, | Six months ended June 30, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Selling, general and administrative expense |
$ | 227,751 | $ | 89,418 | $ | 456,288 | $ | 288,753 | ||||||||
Research and development expense |
(1,267 | ) | 41,803 | (4,314 | ) | 16,426 | ||||||||||
Share-based compensation expense before taxes |
226,484 | 131,221 | 451,974 | 305,179 | ||||||||||||
Related income tax benefits |
| | | | ||||||||||||
Share-based compensation expense |
$ | 226,484 | $ | 131,221 | $ | 451,974 | $ | 305,179 | ||||||||
Net share-based compensation expense per
common share basic and diluted |
$ | 0.02 | $ | 0.04 | $ | 0.04 | $ | 0.08 | ||||||||
In January 2009, we granted restricted stock units under our 2008 Omnibus Incentive Plan to
seven employees that represented the right to receive in the aggregate 148,000 shares of our
common stock. These units were to vest immediately prior to a strategic transaction (as defined
in the documentation evidencing the grant of the units). We would record share-based
compensation expense in connection with these restricted stock units, if at all, only if a
strategic transaction was consummated. All of the restricted stock units granted in January 2009
were subsequently canceled in the first, second and third quarters of 2009 as a result of
employee terminations and resignations and in connection with certain compensation arrangements
with our remaining employees. As of June 30, 2009, restricted stock units representing the right
to receive an aggregate of 126,000 shares of our common stock were outstanding, and, as of June
30, 2010, no restricted stock units were outstanding. |
4
There were no employee or non-employee director stock options exercised during the three and six
months ended June 30, 2010 and 2009. During the three and six months ended June 30, 2010, we
granted stock options to acquire an aggregate of 20,000 and 203,381 shares, respectively, of our
common stock to our employees and non-employee directors with an estimated weighted-average
grant-date fair value of $1.60 and $6.91 per share, respectively. At June 30, 2010, total
unrecognized estimated compensation cost related to non-vested employee and non-employee
director share-based awards granted prior to that date was $1.1 million, which is expected to be
recognized over a weighted-average period of 2.9 years. During the three and six months ended
June 30, 2009, we granted no stock options to our employees or non-employee directors. |
4. | 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 marketable securities. Our
components of comprehensive loss consist only of net loss. For the six months ended June 30,
2010 and 2009, comprehensive loss was $4.3 million and $5.8 million, respectively. |
5. | Net Loss Per Common Share |
Basic and diluted net loss per common share was calculated by dividing the net loss applicable
to common stock for the period by the weighted-average number of common shares outstanding
during the period, without consideration for our outstanding common stock equivalents because
their effect would have been anti-dilutive. Common stock equivalents are included in the
calculation of diluted earnings per common share only if their effect is dilutive. During the
three and six month periods ended June 30, 2010 and 2009, our outstanding common stock
equivalents consisted of options, restricted stock units, warrants and convertible preferred
stock as follows: |
Three and six months ended June 30, | ||||||||
2010 | 2009 | |||||||
Options |
433,737 | 112,490 | ||||||
Restricted stock units |
| 126,000 | ||||||
Warrants |
4,055,030 | 553,151 | ||||||
Convertible preferred stock |
779,092 | | ||||||
5,267,859 | 791,641 | |||||||
6. | Recent Accounting Pronouncements |
In October 2009, the Financial Accounting Standards Board (FASB) issued Accounting Standard
Update (ASU) No. 2009-13, Revenue Recognition (ASC 605) Multiple-Deliverable Revenue
Arrangements, a consensus of the FASB Emerging Issues Task Force. The guidance modifies the fair
value requirements of Accounting Standards Codification (ASC) subtopic 605-25 Revenue
Recognition Multiple Element Arrangements by providing principles for allocation of
consideration among its multiple elements, allowing more flexibility in identifying and
accounting for separate deliverables under an arrangement. An estimated selling price method is
introduced for valuing the elements of a bundled arrangement if vendor-specific objective
evidence or third-party evidence of selling price is not available, and significantly expands
related disclosure requirements. This guidance is effective prospectively for revenue
arrangements entered into or materially modified in fiscal years beginning on or after June 15,
2010. Currently, we have no multiple-deliverable revenue arrangements that would be affected by
this guidance. |
7. | Licensing Revenue |
In June 2010, we announced that we had entered into a license agreement with respect to our
know-how to develop, make, use and sell ANX-510, or CoFactor® (5,10-methylenetetrahydrofolate),
with Theragence, Inc., a California corporation (Theragence). Pursuant to the agreement, we
granted to Theragence an exclusive worldwide license, including the right to grant sublicenses
under certain circumstances, to conduct research on and to develop, make, have made, use, offer
for sale, sell, have sold and import licensed products in any field or use. We are entitled to
receive royalties on net sales of licensed products and up to approximately $30 million in commercial milestone payments based on aggregate gross sales of licensed products in the United
States, European Union and Japan. Theragence agreed to use commercially reasonable efforts to
research, develop and commercialize at least one licensed product. We discontinued active work
on our CoFactor program in October 2008. |
5
In March 2009, we announced that we and our wholly-owned subsidiary, SD Pharmaceuticals, Inc.,
had entered into a license agreement with respect to our product candidate ANX-514 (docetaxel
lyophilized emulsion for injection) with Shin Poong Pharmaceutical Co., Ltd., a company
organized under the laws of the Republic of Korea (Shin Poong), pursuant to which we granted
to Shin Poong an exclusive license, including the right to sublicense, to research, develop,
make, have made, use, offer for
sale, sell and import licensed products, in each case solely for the treatment of cancer by
intravenous administration of formulations of docetaxel as emulsified products and solely in
South Korea. Under the terms of the agreement, we received an upfront licensing fee of $0.3
million, and are entitled to receive a regulatory milestone payment of either $0.2 million or
$0.4 million upon receipt of regulatory approval for marketing a licensed product in South Korea
(the amount depends on whether the Korea Food and Drug Administration requires Shin Poong to
conduct a bioequivalence or clinical study in human subjects prior to receipt of regulatory
approval), one-time commercial milestone payments tied to annual net sales of licensed products
in an aggregate amount of up to $1.5 million and royalty payments on net sales of licensed
products. Shin Poong is responsible for all development and commercial activities related to
ANX-514 in South Korea. If the Korea Food and Drug Administration requires Shin Poong to conduct
a bioequivalence or clinical trial in human subjects prior to receipt of regulatory approval and
we elect not to supply product to conduct such trial, which supply obligation is subject to
limitations, we will pay Shin Poong $0.1 million. |
We received the $0.3 million upfront licensing fee in April 2009. We recognized $0.3 million in
licensing revenue in the three-month period ended March 31, 2009 because the criteria under our
revenue recognition policy were met in that period. |
8. | Supplementary Cash Flow Information |
Noncash investing and financing transactions presented separately from the condensed
consolidated statements of cash flows for the six months ended June 30, 2010 and 2009 and for
the period from inception (June 12, 1996) through June 30, 2010 are as follows: |
Inception | ||||||||||||
(June 12, 1996) | ||||||||||||
Six months ended June 30, | through | |||||||||||
2010 | 2009 | June 30, 2010 | ||||||||||
Supplemental disclosures of cash flow information |
||||||||||||
Interest paid |
$ | 1,629 | $ | | $ | 180,719 | ||||||
Income taxes paid |
| | | |||||||||
Supplemental disclosures of non-cash investing and financing activities: |
||||||||||||
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 |
54,260 | 18,036 | 151,597 | |||||||||
Acquisitions |
| | 24,781,555 | |||||||||
Payment of dividends |
| | 213,000 | |||||||||
Financial advisor services in connection with private placements |
724,286 | | 2,553,554 | |||||||||
Acquisition of treasury stock in settlement of a claim |
| | 34,747 | |||||||||
Cancellation of treasury stock |
| | (34,747 | ) | ||||||||
Assumptions of liabilities in acquisitions |
| | 1,235,907 | |||||||||
Acquisition of license agreement for long-term debt |
| | 161,180 | |||||||||
Cashless exercise of warrants |
| | 4,312 | |||||||||
Dividends accrued |
| | 621,040 | |||||||||
Trade asset converted to available-for-sale asset |
| | 108,000 | |||||||||
Dividends extinguished |
| | 408,240 | |||||||||
Trade payable converted to note payable |
| | 83,948 | |||||||||
Issuance of warrants for return of common stock |
| | 50,852 | |||||||||
Detachable warrants issued with notes payable |
| | 450,000 | |||||||||
Cumulative preferred stock dividends |
7,131,114 | | 12,869,614 |
9. | Severance Related Expenses |
As part of restructuring to reduce operating costs, we completed workforce reductions of nine
employees in the three months ended December 31, 2008 and fifteen employees in the six months
ended June 30, 2009. As a result, we recorded severance-related charges of $350,000 in the
first quarter of 2009, of which $237,000 was recorded in research and development and the
balance was recorded in selling, general and administrative, and $163,000 in the second quarter
of 2009, of which $121,000 was recorded in research and development and the balance was recorded
in selling, general and administrative. As of June 30, 2009, all severance-related costs
associated with these workforce reductions had been paid. |
6
10. | Stockholders Equity |
Reverse Stock Split |
At a special meeting of our stockholders held on August 25, 2009, our stockholders approved a
proposal to authorize our board of directors, in its discretion, to effect a reverse split of
our outstanding common stock without further action by our stockholders. In April 2010, our
board of directors approved a 1-for-25 reverse split of our common stock and on April 23, 2010
at 4:01 p.m. Eastern time, the reverse stock split became effective. As a result of the reverse
stock split, each 25 shares of our issued and outstanding common stock were automatically
reclassified as and changed into one share of our common stock. The reverse stock
split reduced the number of our issued and outstanding shares of common stock as of April 23,
2010 from approximately 257.3 million shares to approximately 10.3 million shares. No
fractional shares were issued in connection with the reverse stock split. Stockholders who were
entitled to fractional shares instead became entitled to receive a cash payment in lieu of
receiving fractional shares (after taking into account and aggregating all shares of our common
stock then held by such stockholder) equal to the fractional share interest multiplied by
$4.6275 (the per share closing price of our common stock (on a post-split basis) as determined
by the NYSE Amex on April 23, 2010). The reverse stock split affected all of the holders of our
common stock uniformly. Shares of our common stock underlying outstanding options and warrants
were proportionately reduced and the exercise prices of outstanding options and warrants were
proportionately increased in accordance with the terms of the agreements governing such
securities. All common stock share and per share information in the condensed consolidated
financial statements and notes thereto included in this report have been restated to reflect
retrospective application of the reverse stock split for all periods presented ending or as of a
date on or prior to April 23, 2010, except for par value per share and the number of authorized
shares, which were not affected by the reverse stock split. |
||
0% Series A Convertible Preferred Stock |
In June 2009, we completed a registered direct equity financing raising gross proceeds of
approximately $2.0 million involving the issuance of 1,993 shares of our 0% Series A Convertible
Preferred Stock with a stated value of $1,000 per share (Series A Stock), and 5-year warrants
to purchase up to 324,651 shares of our common stock at an exercise price of $3.75 per share. In
the aggregate, the shares of Series A Stock we issued were convertible into 721,447 shares of
our common stock. All of the shares of the Series A Stock have been converted into common stock
and are no longer outstanding. We received approximately $1.7 million in net proceeds from the
financing, after deducting the placement agents fees and expenses and other offering expenses.
In December 2009, in connection with the exercise of warrants issued in the June 2009 financing,
we issued 240,000 shares of our common stock and received net proceeds of $0.9 million. In
January 2010, in connection with the exercise of the remaining warrants issued in the June 2009
financing, we issued an additional 84,651 shares of our common stock and received an additional
$0.3 million of net proceeds. All of the warrants we issued in the June 2009 financing have
been exercised and are no longer outstanding. |
The convertible feature of our Series A Stock and the terms of the warrants issued in connection
with our Series A Stock provided for a rate of conversion or exercise that was below the market
value of our common stock at issuance. The convertible feature of our Series A Stock is
characterized as a beneficial conversion feature (BCF). The estimated relative fair values of
the shares of our Series A Stock and the warrants issued in connection with such stock were
calculated as approximately $1.2 million and $531,000, respectively. The value of the BCF was
determined using the intrinsic value method and calculated as approximately $1.2 million.
Because our Series A Stock did not have a stated redemption date, the value of the BCF was fully
realized at the time our Series A Stock was issued. The fair value of the warrants was
determined using the Black-Scholes option-pricing model as of the date of issuance assuming a
five-year term, stock volatility of 197.01%, and a risk-free interest rate of 2.81%. The value
of the BCF was treated as a deemed dividend to the holders of our Series A Stock and, due to the
potential immediate convertibility of our Series A Stock at issuance, was recorded as an
increase to additional paid-in capital and accumulated deficit at the time of issuance. |
We also issued warrants to purchase up to 36,071 shares of our common stock at an exercise price
of $3.75 per share to the placement agent in the June 2009 financing as additional consideration
for its services in connection with the financing. These warrants had a fair value of
approximately $132,000 using the Black-Scholes option-pricing model as of the date of issuance
assuming a five-year term, stock volatility of 196.5%, and a risk-free interest rate of 2.85%.
The warrants became exercisable on December 13, 2009 and are exercisable at any time on or
before June 12, 2014. |
7
5% Series B Convertible Preferred Stock |
In July 2009, we completed a registered direct equity financing raising gross proceeds of
approximately $1.4 million involving the issuance of 1,361 shares of our 5% Series B Convertible
Preferred Stock with a stated value of $1,000 per share (Series B Stock). In the aggregate,
the shares of Series B Stock we issued were convertible into 380,167 shares of our common stock.
All of the shares of our Series B Stock have been converted into common stock and are no longer
outstanding. Our Series B Stock would have accrued a cumulative annual dividend of 5% per share
until July 6, 2014, and no dividend thereafter. In accordance with the terms of the Series B
Stock, because the Series B Stock was converted prior to July 6, 2014, we paid the holders an
amount equal to the total dividend that would have accrued in respect of the shares converted
from the issuance date through July 6, 2014, or $250 per $1,000 of stated value of the shares
converted. We received approximately $0.8 million in net proceeds from the financing after
deducting the $340,250 we placed into an escrow account to pay the aggregate dividend payment in
respect of our Series B Stock, placement agents fees and expenses and other offering expenses. |
The convertible feature of our Series B Stock and the value of the dividend in respect thereof
provided for a rate of conversion that was below the market value of our common stock at
issuance. The convertible feature of our Series B Stock is characterized as a BCF. The estimated
relative fair value of the shares of our Series B Stock was calculated as approximately $1.0
million. The value of the BCF was determined using the intrinsic value method and calculated as
approximately $215,000. Because our Series B Stock did not have a stated redemption date, the
value of the BCF was fully realized at the time our Series B Stock was issued. The value of the
BCF was treated as a deemed dividend to the holders of our Series B Stock and, due to the
potential immediate convertibility of our Series B Stock at issuance, was recorded as an
increase to additional paid-in capital and accumulated deficit at the time of issuance. |
We also issued warrants to purchase up to 19,007 shares of our common stock at an exercise price
of $4.48 per share to the placement agent in the July 2009 financing as additional consideration
for its services in connection with the financing. These warrants had a fair value of
approximately $60,000 using the Black-Scholes option-pricing model as of the date of issuance
assuming a five-year term, stock volatility of 197.37%, and a risk-free interest rate of 2.4%.
The warrants became exercisable on January 7, 2010 and are exercisable at any time on or before
July 6, 2014. |
In August 2009, we completed a registered direct equity financing raising gross proceeds of
approximately $0.9 million involving the issuance of 922 shares of our 5% Series C Convertible
Preferred Stock with a stated value of $1,000 per share (Series C Stock). In the aggregate,
the shares of Series C Stock we issued were convertible into 283,692 shares of our common stock.
All of the shares of our Series C Stock have been converted into common stock and are no longer
outstanding. Our Series C Stock would have accrued a cumulative annual dividend of 5% per share
until February 10, 2012, and no dividend thereafter. In accordance with the terms of the Series
C Stock, because the Series C Stock was converted prior to February 10, 2012, we paid the
holders an amount equal to the total dividend that would have accrued in respect of the shares
converted from the issuance date through February 10, 2012, or $125 per $1,000 of stated value
of the shares converted. We received approximately $0.7 million in net proceeds from the
financing after deducting the $115,250 we placed into an escrow account to pay the aggregate
dividend payment in respect of our Series C Stock, placement agents fees and expenses and other
offering expenses. |
The convertible feature of our Series C Stock and the value of the dividend in respect thereof
provided for a rate of conversion that was below the market value of our common stock at
issuance. The convertible feature of our Series C Stock is characterized as a BCF. The estimated
relative fair value of the shares of our Series C Stock was calculated as approximately
$807,000. The value of the BCF was determined using the intrinsic value method and calculated as
approximately $186,000. Because our Series C Stock did not have a stated redemption date, the
value of the BCF was fully realized at the time our Series C Stock was issued. The value of the
BCF was treated as a deemed dividend to the holders of our Series C Stock and, due to the
potential immediate convertibility of our Series C Stock at issuance, was recorded as an
increase to additional paid-in capital and accumulated deficit at the time of issuance. |
We also issued warrants to purchase up to 14,183 shares of our common stock at an exercise price
of $4.06 per share to the placement agent in the August 2009 financing as additional
consideration for its services in connection with the financing. These warrants had a fair value
of approximately $48,000 using the Black-Scholes option-pricing model as of the date of issuance
assuming a five-year term, stock volatility of 198.94%, and a risk-free interest rate of 2.75%.
The warrants became exercisable on February 10, 2010 and are exercisable at any time on or
before August 10, 2014. |
8
4.25660% Series D Convertible Preferred Stock |
In October 2009, we completed a registered direct equity financing raising gross proceeds of
approximately $11.3 million involving the issuance of 11,283 shares of our 4.25660% Series D
Convertible Preferred Stock with a stated value of $1,000 per share (Series D Stock), and
5-year warrants to purchase up to an aggregate of 792,000 shares of our common stock. In the
aggregate, the shares of Series D Stock we issued were convertible into 2,400,000 shares of our
common stock. All of the shares of our Series D Stock have been converted into common stock and
are no longer outstanding. Our Series D Stock would have accrued a cumulative annual dividend
of 4.25660% per share until October 9, 2020, and no dividend thereafter. In accordance with the
terms of the Series D Stock, because the Series D Stock was converted prior to October 9, 2020,
we paid the holders an amount equal to the total dividend that would have accrued in respect of
the shares converted from the issuance date through October 9, 2020, or $468.23 per $1,000 of
stated value of the shares converted. We received approximately $5.1 million in net proceeds
from the financing after deducting the approximately $5.3 million we placed into an escrow
account to pay the aggregate dividend payment in respect of our Series D Stock, placement
agents fees and expenses and other offering expenses. In December 2009, in connection with the
exercise of warrants issued in the October 2009 financing, we issued 576,000 shares of our
common stock and received net proceeds of $2.1 million. We may receive an additional $0.8
million of net proceeds from the
exercise of the remaining warrants issued in the October 2009 financing. Those warrants, which
have an exercise price of $3.67 per share, are exercisable any time on or before October 9,
2014, subject to certain beneficial ownership limitations. |
The convertible feature of our Series D Stock and the terms of the warrants issued in connection
with our Series D Stock provide for a rate of conversion or exercise that was below the market
value of our common stock at issuance. The convertible feature of our Series D Stock is
characterized as BCF. The estimated relative fair values of the shares of our Series D Stock
and the warrants issued in connection with such stock were calculated as approximately $3.9
million and $1.3 million, respectively. The value of the BCF was determined using the intrinsic
value method and calculated as approximately $3.3 million. Because our Series D Stock did not
have a stated redemption date, the value of the BCF was fully realized at the time our Series D
Stock was issued. The fair value of the warrants was determined using the Black-Scholes
option-pricing model as of the date of issuance assuming a five-year term, stock volatility of
197.63%, and a risk-free interest rate of 2.36%. The value of the BCF was treated as a deemed
dividend to the holders of our Series D Stock and, due to the potential immediate convertibility
of our Series D Stock at issuance, was recorded as an increase to additional paid-in capital and
accumulated deficit at the time of issuance. |
We also issued warrants to purchase up to 144,000 shares of our common stock at an exercise
price of $5.88 per share to the placement agent in the October 2009 financing as additional
consideration for its services in connection with the financing. These warrants had a fair
value of approximately $452,000 using the Black-Scholes option-pricing model as of the date of
issuance assuming a five-year term, stock volatility of 197.63%, and a risk-free interest rate
of 2.36%. The warrants are exercisable at any time on or after April 7, 2010 and on or before
October 6, 2014. |
||
3.73344597664961% Series E Convertible Preferred Stock |
In January 2010, we completed a registered direct equity financing raising gross proceeds of
$19.0 million involving the issuance of 19,000 shares of our 3.73344597664961% Series E
Convertible Preferred Stock with a stated value of $1,000 per share (Series E Stock), and
30-month warrants to purchase up to an aggregate of 498,488 shares of our common stock. In the
aggregate, the shares of Series E Stock we issued were convertible into 1,993,965 shares of our
common stock. All of the shares of our Series E Stock have been converted into common stock and
are no longer outstanding. Our Series E Stock would have accrued a cumulative annual dividend
of 3.73344597664961% per share until January 7, 2015, and no dividend thereafter. In accordance
with the terms of the Series E Stock, because the Series E Stock was converted prior to January
7, 2015, we paid the holders an amount equal to the total dividend that would have accrued in
respect of the shares converted from the issuance date through January 7, 2015, or $186.67 per
$1,000 of stated value of the shares converted. We received approximately $14.0 million in net
proceeds from the financing after deducting the approximately $3.5 million we placed into an
escrow account to pay the aggregate dividend payment in respect of our Series E Stock, placement
agents fees and expenses and other offering expenses. We may receive up to approximately $4.4
million of additional proceeds from the exercise of the warrants issued in the January 2010
financing. Those warrants, which have an exercise price of $8.75 per share, are exercisable any
time on or before July 6, 2012, subject to certain beneficial ownership limitations. |
The convertible feature of our Series E Stock and the terms of the warrants issued in connection
with our Series E Stock provide for a rate of conversion or exercise that was below the market
value of our common stock at issuance. The convertible feature of our Series E Stock is
characterized as BCF. The estimated relative fair values of the shares of our Series E Stock
and the warrants issued in connection with such stock were calculated as approximately $12.4
million and $3.0 million, respectively. The value of the BCF was determined using the intrinsic
value method and calculated as approximately $2.5 million. Because our Series E Stock did not
have a stated redemption date, the value of the BCF was fully realized at the time our Series E
Stock was issued. The fair value of the warrants was determined using the Black-Scholes
option-pricing model as of the date of issuance assuming a 30-month term, stock volatility of
275.79%, and a risk-free interest rate of 1.325%. The value of the BCF was treated as a deemed
dividend to the holders of our Series E Stock and, due to the potential immediate convertibility
of our Series E Stock at issuance, was recorded as an increase to additional paid-in capital and
accumulated deficit at the time of issuance. |
9
We also issued warrants to purchase up to 99,696 shares of our common stock at an exercise price
of $11.91 per share to the placement agent in the January 2010 financing as additional
consideration for its services in connection with the financing. These warrants had a fair
value of approximately $724,000 using the Black-Scholes option-pricing model as of the date of
issuance assuming a 4.5-year term, stock volatility of 209.46%, and a risk-free interest rate of
2.37%. The warrants are exercisable at any time on or after July 7, 2010 and on or before June
3, 2014. |
||
2.19446320054018% Series F Convertible Preferred Stock |
In May 2010, we completed a registered direct equity financing raising gross proceeds of $19.2
million involving the issuance of 19,217.13 shares of our 2.19446320054018% Series F Convertible
Preferred Stock with a stated value of $1,000 per share
(Series F Stock), and 5-year and 1-year warrants to purchase up to an aggregate of 2,595,156
shares of our common stock. In the aggregate, the shares of Series F Stock we issued are
convertible into 5,190,312 shares of our common stock. As of June 30, 2010, 2,883.57 shares of
our Series F Stock were outstanding. All other shares of Series F Stock have been converted into
an aggregate of 4,411,220 shares of our common stock. We received approximately $13.3 million
in net proceeds from the financing after deducting the approximately $4.2 million we placed into
an escrow account to pay the aggregate dividend payment in respect of our Series F Stock,
placement agent and financial advisor fees and other offering expenses. We may receive up to
approximately $9.5 million of additional proceeds from the exercise of the warrants issued in
the May 2010 financing. The exercise price of the warrants is $3.65 per share. Subject to
certain beneficial ownership limitations, the 5-year warrants are exercisable any time on or
before May 6, 2015 and the 1-year warrants are exercisable any time on or before May 20, 2011. |
Our Series F Stock accrues a cumulative annual dividend of 2.19446320054018% per share until May
6, 2020, and no dividend thereafter. To the extent shares of our Series F Stock are converted at
any time prior to May 6, 2020, we are obligated to pay the holder an amount equal to the total
dividend that would have accrued in respect of the shares converted, or $219.45 per $1,000 of
stated value of the shares converted, less the amount of any dividend paid on such shares before
their conversion. As of June 30, 2010, we have paid an aggregate of $3.6 million out of the
escrow account in connection with payments due upon conversion of shares of our Series F Stock,
and there was approximately $0.6 million, which we classify as restricted cash, remaining in the
escrow account for the benefit of the holders of outstanding shares of our Series F Stock. The
dividend on our Series F Stock is payable quarterly on January 1, April 1, July 1 and October 1.
On July 1, 2010, we made a prorated payment of approximately $9,500 out of the escrow account
for the first quarterly dividend to the holders of outstanding shares of our Series F Stock. |
The convertible feature of our Series F Stock and the terms of the warrants issued in connection
with our Series F Stock provide for a rate of conversion or exercise that was below the market
value of our common stock at issuance. The convertible feature of our Series F Stock is
characterized as BCF. The estimated relative fair values of the shares of our Series F Stock
and the warrants issued in connection with such stock were calculated as approximately $10.1
million and $4.9 million, respectively. The value of the BCF was determined using the intrinsic
value method and calculated as approximately $3.1 million. Because our Series F Stock did not
have a stated redemption date, the value of the BCF was fully realized at the time our Series F
Stock was issued. The fair value of the 5-year warrants was determined using the Black-Scholes
option-pricing model as of the date of issuance assuming a 5-year term, stock volatility of
202%, and a risk-free interest rate of 2%. The fair value of the 1-year warrants was determined
using the Black-Scholes option-pricing model as of the date of issuance assuming a 1-year term,
stock volatility of 361%, and a risk-free interest rate of 0.4%. The value of the BCF was
treated as a deemed dividend to the holders of our Series F Stock and, due to the potential
immediate convertibility of our Series F Stock at issuance, was recorded as an increase to
additional paid-in capital and accumulated deficit at the time of issuance. |
||
Common Stock Issued for Warrants Exercised |
As described above, in January 2010, we issued 84,651 shares of our common stock and received
net proceeds of $0.3 million in connection with the exercise of the remaining warrants issued in
the June 2009 financing at an exercise price of $3.75 per share. |
11. | Subsequent Events |
In accordance with ASC 855, we have evaluated for disclosure in the financial statements events
occurring subsequent to June 30, 2010 through the date and time the financial statements were
issued. |
10
Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations |
11
12
13
14
| the number and location of sites included in trials and the rate of site approval for
the trial; |
||
| the rates of patient recruitment and enrollment; |
||
| the ratio of randomized to evaluable patients; |
||
| the availability and cost of reference product in the jurisdiction of each site; |
||
| the time and cost of process development activities related to our product
candidates; |
||
| the costs of manufacturing our product candidates; |
||
| the time and cost of stability studies, including the need to identify critical
parameters, methods to evaluate and test these parameters and validation of such methods
and tests; and |
||
| the costs, requirements, timing of and the ability to secure regulatory approvals. |
15
January 1, 2005 | ||||||||||||
through | ||||||||||||
Three months ended June 30, | June 30, | |||||||||||
2010 | 2009 | 2010 | ||||||||||
External bioequivalence and clinical trial fees and expenses |
$ | 18,338 | $ | (44,143 | ) | $ | 23,848,687 | |||||
External nonclinical study fees and expenses (1) |
558,175 | 1,325,361 | 25,769,208 | |||||||||
Personnel costs |
58,520 | 131,875 | 10,381,736 | |||||||||
Stock-based compensation expense |
(1,267 | ) | 41,803 | 2,921,416 | ||||||||
Total |
$ | 633,766 | $ | 1,454,896 | $ | 62,921,047 | ||||||
(1) | External nonclinical study fees and expenses include preclinical, research-related
manufacturing, quality assurance and regulatory expenses. |
16
Six months ended June 30, | ||||||||
2010 | 2009 | |||||||
External bioequivalence and clinical trial fees and expenses |
$ | 46,111 | $ | 534,851 | ||||
External nonclinical study fees and expenses (1) |
1,740,260 | 1,795,609 | ||||||
Personnel costs |
91,038 | 755,311 | ||||||
Stock-based compensation expense |
(4,314 | ) | 16,426 | |||||
Total |
$ | 1,873,095 | $ | 3,102,197 | ||||
(1) | External nonclinical study fees and expenses include preclinical, research-related
manufacturing, quality assurance and regulatory expenses. |
17
18
| the extent to which we acquire new technologies, product candidates, products or
businesses and our ability to integrate them successfully into our operations; |
||
| the potential that we may enter into a merger or other business combination whereby
the stockholders who own the majority of our voting securities prior to the transaction
own less than a majority after the transaction; |
||
| our or a future partners ability to obtain regulatory approval for our product
candidates and, if approved, to successfully commercialize them in the U.S. and/or
elsewhere; |
||
| the potential that we may enter into one or more commercial partnerships or other
strategic transactions relating to Exelbine and/or ANX-514, and the terms of any such
transactions; |
||
| our ability to obtain stockholder approval to complete a product pipeline expansion
transaction, if necessary, on a timely basis, or at all; |
||
| our ability to obtain additional funding on a timely basis or on acceptable terms, or
at all; |
||
| the extent to which we rebuild our workforce and our ability to attract and retain
qualified personnel and manage growth; |
||
| delays in the commencement or completion of nonclinical testing, bioequivalence or
clinical trials of or manufacturing, regulatory or launch activities related to our
product candidates; |
||
| the success of future bioequivalence or clinical trials;
|
19
| our ability to develop sales, marketing and distribution capabilities, if we
determine to commercialize any of our product candidates for which we obtain regulatory
approval without a partner; |
||
| whether any of our product candidates for which we receive regulatory approval, if
any, achieve broad market acceptance; |
||
| our ability to maintain our relationships with the single source manufacturers and
suppliers for certain of our product candidates and their component materials and the
ability of such manufacturers and suppliers to successfully and consistently manufacture
and supply, as applicable, our products and their component materials on a commercial
scale, if we receive regulatory approval to commercialize our product candidates; |
||
| the satisfactory performance of third parties on whom we rely significantly to
conduct our nonclinical testing and bioequivalence and clinical studies and other
aspects of our development programs; |
||
| undesirable side effects that our product candidates may cause; |
||
| our ability to protect our intellectual rights with respect to our product candidates
and proprietary technology; |
||
| claims against us for infringing the proprietary rights of third parties; |
||
| competition in the marketplace for our products, if any are approved; |
||
| healthcare reform measures and reimbursement policies that, if not favorable to our
products, could hinder or prevent our products commercial success; |
||
| potential product liability exposure and, if successful claims are brought against
us, liability for a product or product candidate; |
||
| our ability to maintain compliance with NYSE Amex continued listing standards and
maintain the listing of our common stock on the NYSE Amex or another national securities
exchange; and |
||
| the other factors that are described in the section entitled Risk Factors, in Item
1A of Part I of our annual report on Form 10-K for the year ended December 31, 2009. |
Item 3. | Quantitative and Qualitative Disclosures About Market Risk |
Item 4. | Controls and Procedures |
20
Item 1. | Legal Proceedings |
Item 1A. | Risk Factors |
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
Item 3. | Defaults Upon Senior Securities |
Item 4. | (Removed and Reserved) |
Item 5. | Other Information |
Item 6. | Exhibits |
21
ADVENTRX Pharmaceuticals, Inc. |
||||
Date: August 10, 2010 | By: | /s/ Brian M. Culley | ||
Brian M. Culley | ||||
Chief Executive Officer (Principal Executive Officer) |
||||
By: | /s/ Patrick L. Keran | |||
Patrick L. Keran | ||||
President and Chief Operating Officer (Principal Financial and Accounting Officer) |
22
Exhibit | Description | |||
3.1 | (1) | Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the registrant, dated
April 23, 2010 |
||
3.2 | (2) | Certificate of Designation of Preferences, Rights and Limitations of 2.19446320054018% Series F Convertible
Preferred Stock |
||
10.1 | (2) | Engagement Letter Agreement, dated April 29, 2010, by and between the registrant and Rodman & Renshaw, LLC |
||
10.2 | (2) | Form
of Securities Purchase Agreement, dated May 2, 2010, by and
between the registrant and the purchasers listed on the signature pages thereto |
||
10.3 | (2) | Form of Series A and B Common Stock Purchase Warrants issued on May 6, 2010 by the registrant to the purchasers of
the registrants 2.19446320054018% Series F Convertible Preferred Stock |
||
31.1 | Certification of principal executive officer pursuant to Rules 13a-14(a)/15d-14(a) |
|||
31.2 | Certification of principal financial officer pursuant to Rules 13a-14(a)/15d-14(a) |
|||
32.1 | * | Certification of principal executive officer and principal financial officer pursuant to 18 U.S.C. 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
* | This certification is being furnished solely to accompany this report pursuant to 18 U.S.C. 1350, and is not
being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and is 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. |
|
(1) | Filed with the registrants Current Report on Form 8-K on April 26, 2010 (SEC file number 001-32157-10769058) |
|
(2) | Filed with the registrants Current Report on Form 8-K on May 3, 2010 (SEC file number 001-32157-10790486) |
23