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Filing
Table of Contents
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): November 9, 2006
ADVENTRX Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware | 001-32157 | 84-1318182 | ||
(State or Other Jurisdiction of Incorporation) |
(Commission File No.) | (IRS Employer Identification No.) |
6725 Mesa Ridge Road, Suite 100
San Diego, CA 92121
(Address of Principal Executive Offices and Zip Code)
San Diego, CA 92121
(Address of Principal Executive Offices and Zip Code)
N/A
(Former name or former address if changed since last report)
(Former name or former address if changed since last report)
Registrants telephone number, including area code: (858) 552-0866
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy
the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c))
TABLE OF CONTENTS
Item 2.02. Results of Operations and Financial Condition | ||||||||
Item 9.01. Financial Statements and Exhibits | ||||||||
SIGNATURE | ||||||||
INDEX TO EXHIBITS | ||||||||
EXHIBIT 99.1 |
Table of Contents
Item 2.02. Results of Operations and Financial Condition.
On November 9, 2006, ADVENTRX Pharmaceuticals, Inc. issued a press release announcing its financial
results for the quarterly period ended September 30, 2006. A copy of this press release is
furnished as Exhibit 99.1 hereto
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The list of exhibits called for by this Item is incorporated by reference to the Index to
Exhibits filed with this report.
Table of Contents
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
ADVENTRX Pharmaceuticals, Inc. | ||||||
Dated: November 9, 2006
|
By: | /s/ Evan M. Levine
|
||||
Title: Chief Executive Officer |
Table of Contents
EXHIBIT 99.1
ADVENTRX ANNOUNCES 2006 THIRD QUARTER FINANCIAL RESULTS
SAN DIEGO November 9, 2006 ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced
financial results for the quarterly period ended September 30, 2006.
ADVENTRX reported loss from operations of $5.1 million for the third quarter of 2006, compared with
loss from operations of $3.5 million for the third quarter of 2005. Operating expenses grew as
expected and were primarily due to the Companys ongoing clinical trials of CoFactorâ. Net
loss, which includes gain on fair value of warrants of $498,000, was $4.6 million, or $0.06 per
share, for the third quarter of 2006, compared with a net loss, which included loss on fair value
of warrants of $13.0 million, of $16.5 million, or $0.26 per share, for the third quarter of 2005.
In the third quarter we continued to make significant progress in the development of CoFactor and
in the preparation of our other product candidates for clinical development, said Evan M. Levine,
ADVENTRX chief executive officer. In September, we announced that we completed patient enrollment
in our 300-patient CoFactor Phase IIb clinical trial for metastatic colorectal cancer (mCRC), for
which we expect to announce data in the second half of 2007. In addition, we continue to enroll
patients and initiate sites for our CoFactor Phase III pivotal clinical trial for mCRC, and are
making preparations for a clinical trial in refractory breast cancer. We expect to initiate this
CoFactor clinical trial in refractory breast cancer and to file an investigational new drug
application for a bioequivalency clinical trial for ANX-530, vinorelbine emulsion, in the fourth
quarter of 2006.
In the third quarter, we strengthened our clinical and management teams with several key
appointments. We added James Merritt, MD, an oncologist and accomplished biopharmaceutical
executive, as president and chief medical officer, and Joachim Schupp, MD, a veteran of Novartis
Pharma AG, as vice president of medical affairs. We also brought on Patrick Keran as general
counsel and appointed Jack Lief, chairman and chief executive officer for Arena Pharmaceuticals,
and Dr. Alex Denner, a member of the board of directors of ImClone Systems Incorporated and a
managing director of entities affiliated with Carl Icahn, to our board of directors. I am pleased
that top-tier individuals who understand our industry appreciate the value of our pipeline and are
excited to participate in and help shape our success.
Third Quarter and First Three Quarters of 2006 Financial Review
Research and development expenses for the third quarter of 2006 were $3.2 million, versus $1.9
million for the third quarter of 2005. This increase was due primarily to increased costs of the
Phase IIb and Phase III CoFactor clinical trials as patients continued to be enrolled in the
trials, as well as increased preclinical costs related to drug development.
General and administrative expenses for the 2006 third quarter were $2.1 million, compared with
$1.7 million for the same period in 2005. This increase is due primarily to continuing costs
related to being a publicly-held company and costs of continuing operations in support of research
and development efforts.
For the nine months ended September 30, 2006, net loss was $22.9 million, or ($0.32) per share,
compared with a net loss of $22.6 million, or ($0.39) per share, for the same period in 2005.
For the first nine months of 2006, research and development expenses were $8.9 million, compared
with $5.9 million for the first nine months of 2005. The increase for the nine months is primarily
due to expenses related to CoFactor clinical trials and hiring of personnel.
General and administrative expenses for first nine months of 2006 were $5.5 million, compared with
$3.9 million for the same period in 2005. The increase was due to factors discussed above as well
as increased personnel costs due to new hires and stock-based compensation charges.
ADVENTRX reported cash, cash equivalents and short-term investments of approximately $17.1 million
as of September 30, 2006, compared with $22.6 million as of December 31, 2005, and no long-term
debt. Subsequent to September 30, the Company announced a registered direct offering of 14,545,000
shares of common stock at a price of $2.75 per share for gross proceeds of approximately $40
million.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on
commercializing low development risk pharmaceuticals for cancer and infectious disease that enhance
the efficacy and/or safety of existing therapies. More information can be found on ADVENTRXs web
site at www.adventrx.com.
Forward Looking Statement
ADVENTRX cautions you that statements included in this press release that are not a description of
historical facts are forward-looking statements that involve risks, uncertainties, assumptions and
other factors that, if they do not materialize or prove to be accurate, could cause ADVENTRXs
results to differ materially from historical results or those expressed or implied by such
forward-looking statements. Such forward-looking statements are made based on managements current
expectations and beliefs and should not be regarded as a statement or representation by ADVENTRX
that any of its plans, including its anticipated milestones, will be achieved on time or at all.
The potential risks and uncertainties that could cause actual results to differ materially include,
but are not limited to: the risk that ADVENTRX will be unable to raise sufficient capital to fund
the projects necessary to meet its anticipated or stated goals and milestones; the potential to
attract a strategic partner and the terms of any related transaction; the ability to timely enroll
subjects in ADVENTRXs current and anticipated clinical trials; the potential for CoFactor® and
ADVENTRXs other product candidates to receive regulatory approval for one or more indications on a
timely basis or at all, and the uncertain process of seeking regulatory approval; other
difficulties or delays in developing, testing, manufacturing and marketing of and obtaining
regulatory approval for CoFactor® or ADVENTRXs other product candidates; the potential for
regulatory authorities to require additional preclinical work or other clinical requirements to
support regulatory filings; the scope and validity of patent protection for CoFactor® and
ADVENTRXs other product candidates; and other risks and uncertainties more fully described in
ADVENTRXs press releases and periodic filings with the Securities and Exchange Commission.
ADVENTRXs public filings with the Securities and Exchange Commission are available at
http://www.sec.gov.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only
as of the date when made. All forward-looking statements are qualified in their entirety by this
cautionary statement and ADVENTRX assumes no obligation to revise or update any forward-looking
statement, including as set forth in this press release, to reflect events or circumstances arising
after the date on which it was made.
Contact:
ADVENTRX Pharmaceuticals
Andrea Lynn
858-552-0866
ADVENTRX Pharmaceuticals
Andrea Lynn
858-552-0866
[Tables to Follow]
# # #
ADVENTRX PHARMACEUTICALS, INC.
(A Development Stage Enterprise)
Condensed Consolidated Statements of Operations
(unaudited)
(A Development Stage Enterprise)
Condensed Consolidated Statements of Operations
(unaudited)
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
2006 | 2005 | 2006 | 2005 | |||||||||||||
Net sales |
$ | | $ | | $ | | $ | | ||||||||
Cost of goods sold |
| | | | ||||||||||||
Gross margin |
| | | | ||||||||||||
Grant revenue |
| | | | ||||||||||||
Interest income |
221,271 | 159,373 | 709,912 | 261,292 | ||||||||||||
221,271 | 159,373 | 709,912 | 261,292 | |||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
3,223,554 | 1,870,465 | 8,941,147 | 5,893,288 | ||||||||||||
General and administrative |
2,055,441 | 1,737,052 | 5,545,370 | 3,929,546 | ||||||||||||
Depreciation and amortization |
49,326 | 34,331 | 127,528 | 96,422 | ||||||||||||
In-process research and
development |
| | 10,422,130 | | ||||||||||||
Impairment loss write off of
goodwill |
| | | | ||||||||||||
Interest expense |
| | | | ||||||||||||
Equity in loss of investee |
| | | | ||||||||||||
Total operating
expenses |
5,328,321 | 3,641,848 | 25,036,175 | 9,919,256 | ||||||||||||
Loss from operations |
(5,107,050 | ) | (3,482,475 | ) | (24,326,263 | ) | (9,657,964 | ) | ||||||||
Gain (loss) on fair value of
warrants |
497,869 | (12,972,392 | ) | 1,434,115 | (12,972,392 | ) | ||||||||||
Loss before cumulative effect
of change in accounting
principle |
(4,609,181 | ) | (16,454,867 | ) | (22,892,148 | ) | (22,630,356 | ) | ||||||||
Cumulative effect of change in
accounting principle |
| | | | ||||||||||||
Net loss |
(4,609,181 | ) | (16,454,867 | ) | (22,892,148 | ) | (22,630,356 | ) | ||||||||
Preferred stock
dividends |
| | | | ||||||||||||
Net loss applicable
to common stock |
$ | (4,609,181 | ) | $ | (16,454,867 | ) | $ | (22,892,148 | ) | $ | (22,630,356 | ) | ||||
Net loss per common share basic
and diluted: |
$ | (.06 | ) | $ | (.26 | ) | $ | (.32 | ) | $ | (.39 | ) | ||||
Weighted average shares basic
and diluted |
73,435,715 | 63,255,407 | 70,895,528 | 57,346,039 | ||||||||||||
ADVENTRX PHARMACEUTICALS, INC.
(A Development Stage Enterprise)
Condensed Consolidated Balance Sheets
(A Development Stage Enterprise)
Condensed Consolidated Balance Sheets
September 30, | December 31, | |||||||
2006 | 2005 | |||||||
(unaudited) | ||||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 16,201,019 | $ | 14,634,618 | ||||
Accrued interest income |
13,384 | 10,214 | ||||||
Prepaid expenses |
916,115 | 255,802 | ||||||
Short-term investments |
894,489 | 7,958,458 | ||||||
Total current assets |
18,025,007 | 22,859,092 | ||||||
Property and equipment, net |
447,445 | 407,544 | ||||||
Other assets |
301,305 | 355,137 | ||||||
Total assets |
$ | 18,773,757 | $ | 23,621,773 | ||||
Liabilities and Shareholders Deficiency |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 73,584 | $ | 593,228 | ||||
Accrued liabilities |
1,873,091 | 930,274 | ||||||
Accrued salary and related taxes |
435,911 | 173,398 | ||||||
Warrant liability |
28,262,296 | 29,696,411 | ||||||
Total current liabilities |
30,644,882 | 31,393,311 | ||||||
Long-term liabilities |
41,019 | 57,078 | ||||||
Total liabilities |
30,685,901 | 31,450,389 | ||||||
Commitments and contingencies |
||||||||
Temporary equity: |
||||||||
Common stock subject to continuing registration,
$.001 par value; 10,810,809 shares issued and
outstanding |
| | ||||||
Shareholders deficiency: |
||||||||
Common stock, $0.001 par value. Authorized
200,000,000 shares; issued 63,260,334 shares in 2006
and 56,529,388 shares in 2005 |
74,095 | 67,364 | ||||||
Additional paid-in capital |
70,904,626 | 52,105,329 | ||||||
Accumulated other comprehensive income (loss) |
870 | (1,722 | ) | |||||
Deficit accumulated during the development stage |
(82,856,988 | ) | (59,964,840 | ) | ||||
Treasury stock, 23,165 shares at cost |
(34,747 | ) | (34,747 | ) | ||||
Total shareholders deficiency |
(11,912,144 | ) | (7,828,616 | ) | ||||
Total liabilities and shareholders deficiency |
$ | 18,773,757 | $ | 23,621,773 | ||||