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Filing
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT PURSUANT
TO
SECTION 13 OR 15 (d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date of
Report (Date of earliest event reported) April
4, 2005
ADVENTRX
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
Delaware
(State or
other jurisdiction of incorporation)
001-32157
(Commission
File Number) |
84-1318182
(IRS
Employer Identification No.) |
6725
Mesa Ridge Road, Suite 100
San
Diego, California 92121
(Address
of principal executive offices) (Zip Code)
(858)
552-0866
(Company’s
telephone number, including area code)
Item
8.01. Other Events.
On April
4, 2005, the Company issued a corrected press release announcing its 2004 Fourth
Quarter and Full Year Financial Results.
The
corrected press release issued by the Company on April 4, 2005 with respect to
these matters is included with this report as an exhibit.
Item
9.01. Financial Statements and Exhibits.
(c) | The exhibit list required by this item is incorporated by reference to the Exhibit Index filed as part of this report. |
SIGNATURES
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. | ||
|
|
|
By: | /s/ Carrie E. Carlander | |
Name: Carrie E. Carlander | ||
Title: Chief Financial Officer, Vice President, Finance, and Treasurer | ||
April 4, 2005 |
EXHIBIT
INDEX
Exhibit |
Description |
99.1 |
Press
Release of the Company dated April 4, 2005. |
Exhibit
99.1
CORRECTING
and REPLACING ADVENTRX ANNOUNCES 2004 FOURTH QUARTER AND FULL YEAR FINANCIAL
RESULTS
SAN
DIEGO - April 4, 2005 - Please
replace the release dated March 31, 2005, with the following corrected version,
which reflects ADVENTRX' reallocation of expenses for the 2004 and 2003 fourth
quarters with no impact on net loss.
The
corrected release reads:
ADVENTRX
ANNOUNCES 2004 FOURTH QUARTER AND FULL YEAR FINANCIAL
RESULTS
ADVENTRX
Pharmaceuticals, Inc. (Amex: ANX) today announced financial results for the
three and 12 months ended December 31, 2004.
For the
fourth quarter of 2004, ADVENTRX reported a net loss of $2.4 million, or $0.04
per share, compared with a net loss of $815,000, or $0.02 per share, for the
fourth quarter of 2003. For the year ended December 31, 2004, net loss was $6.7
million, or $0.13 per share, compared with a net loss of $2.4 million, or $0.07
per share, for the same period in 2003.
“Our most
significant accomplishment during the past year was hitting the primary clinical
endpoint of response rate for our Phase II metastatic colorectal cancer trial
with CoFactor ™. We rapidly enrolled 50 patients for this trial and we plan to
announce preliminary data in the second quarter of this year,” said Evan M.
Levine, ADVENTRX president and chief executive officer. “Additionally, we were
granted orphan drug status for CoFactor, our biomodulator developed to enhance
the activity of the widely used cancer drug 5-fluorouracil, or 5-FU, in both the
US and European Union (EU) for pancreatic cancer.
“Further,
we secured additional capital and strengthened our senior management to support
our drug development programs,” Mr. Levine continued. “Our plan is to commit the
majority of our resources to the development of CoFactor, where we see the most
significant near-term opportunity for market approval. This year we have already
filed for clearance to initiate a Phase III trial in the US and a Phase IIb
trial in the EU with CoFactor in metastatic colorectal cancer and we intend to
file in the first half of this year for clearance to initiate an EU-based Phase
III study in pancreatic cancer.”
Fourth
Quarter and Full Year Financial Review
Research
and development (R&D) expenses for the fourth quarter of 2004 were $691,000,
compared with $334,000 for the same period in 2003. The increase in R&D
expenses for the 2004 fourth quarter was due primarily to initiation of a
clinical trial and continued preclinical development of portfolio drugs. General
and administrative expenses for the fourth quarter were $1.7 million, compared
with $482,000 for the same period in 2003. The increase for the 2004 fourth
quarter was due primarily to higher costs for facilities, addition of personnel,
and increased legal fees primarily for corporate, human resources and
intellectual property activity.
For the
full year of 2004 R&D expenses were $2.7 million, compared with $749,000 for
full year of 2003. The increase in 2004 R&D expenses was due mainly to
initiation of a clinical trial and continued preclinical development of
portfolio drugs. General and administrative expenses increased to $4.0 million
in 2004, from $1.6 million in 2003, primarily due to expansion of facilities,
addition of personnel, and increased legal fees for corporate and intellectual
property activity.
ADVENTRX
reported cash and cash equivalents of approximately $13.0 million at December
31, 2004, compared with $4.2 million as of December 31, 2003. The cash increase
reflects the completion of a private placement announced on April 5, 2004,
resulting in gross proceeds of approximately $15.6 million.
Annual
Meeting of Stockholders
ADVENTRX
will hold its 2004 Annual Meeting of Stockholders on May 24,
2005 at 10:00 a.m. Pacific Daylight Time at the Company’s headquarters, located
at 6725 Mesa
Ridge Road, Suite 100, San Diego, Calif. Proxy materials along with pertinent
information will be mailed to stockholders of record prior to the date of the
meeting.
About
CoFactor
CoFactor
is a folate-based biomodulator drug developed to enhance the activity of the
widely used cancer chemotherapeutic, 5-FU. Clinical data from previous clinical
trials in Europe have demonstrated clinical benefit and improved overall median
survival in patients with advanced tumors, including colorectal, pancreatic and
breast. CoFactor blocks cancer cell growth by creating more stable binding,
compared to leucovorin, of the target enzyme, thymidylate synthase (TS).
CoFactor bypasses the chemical pathway required by leucovorin to deliver the
active form of folate to allow 5-FU to work more effectively. This improves 5-FU
performance and lowers toxicity. ADVENTRX is the exclusive licensee of this
compound.
About
ADVENTRX
ADVENTRX
Pharmaceuticals is a biopharmaceutical research and development company focused
on introducing new technologies for anticancer and antiviral treatments that
improve the performance of existing drugs and address significant problems such
as drug metabolism, bioavailability and resistance. More information can be
found on the Company's Web site at www.adventrx.com.
Forward
Looking Statement
This
press release contains forward-looking statements within the meaning of the
"safe harbor" provisions of the Private Securities Litigation Reform Act of
1995. Such statements are made based on management's current expectations and
beliefs. Actual results may vary from those currently anticipated based upon a
number of factors, including uncertainties inherent in the drug development
process, the timing and success of clinical trials, the validity of research
results, and the receipt of necessary approvals from the FDA and other
regulatory agencies. For a discussion of such risks and uncertainties, which
could cause actual results to differ from those contained in the forward-looking
statements, see “Risk Factors” in the Company’s last quarterly report on Form
10-QSB, as well as other reports that the Company files from time to time with
the Securities and Exchange Commission. All forward-looking statements are
qualified in their entirety by this cautionary statement. The Company undertakes
no obligation to release publicly any revisions, which may be made to reflect
events or circumstances after the date hereof.
Contact:
ADVENTRX
Pharmaceuticals
Andrea
Lynn
858-552-0866
Investor
Contact:
Lippert
Heilshorn & Associates
Jody Cain
(jcain@lhai.com)
Brandi
Floberg (bfloberg@lhai.com)
310-691-7100
ADVENTRX
PHARMACEUTICALS, INC.
(Formerly
Biokeys Pharmaceuticals, Inc.)
(A
Development Stage Enterprise)
Condensed
Statements of Operations
Three
months ended December 31, |
Year
ended December 31, |
||||||||||||
2004 |
2003 |
2004 |
2003 |
||||||||||
Net
sales |
$ |
— |
$ |
— |
$ |
— |
$ |
— |
|||||
Cost
of goods sold |
—
|
—
|
—
|
—
|
|||||||||
Gross
margin |
—
|
—
|
—
|
—
|
|||||||||
Grant
revenue |
—
|
—
|
—
|
3,603
|
|||||||||
Interest
income |
58,300
|
4,805
|
103,042
|
9,269
|
|||||||||
58,300
|
4,805
|
103,042
|
12,872
|
||||||||||
Operating
expenses: |
|||||||||||||
Research
and development |
691,197
|
333,696
|
2,744,328
|
748,997
|
|||||||||
General
and administrative |
1,702,517
|
482,420
|
4,018,453
|
1,585,596
|
|||||||||
Depreciation
and amortization |
22,110
|
3,824
|
41,309
|
8,970
|
|||||||||
Interest
expense |
—
|
—
|
—
|
1,386
|
|||||||||
Total
operating expenses |
2,415,824
|
819,940
|
6,804,090
|
2,344,949
|
|||||||||
Net
loss |
(2,357,524 |
) |
(815,135 |
) |
(6,701,048 |
) |
(2,332,077 |
) | |||||
Preferred
stock dividends |
—
|
(9,460 |
) |
—
|
(37,840 |
) | |||||||
Net
loss applicable to common stock |
$ |
(2,357,524 |
) |
$ |
(824,595 |
) |
$ |
(6,701,048 |
) |
$ |
(2,369,917 |
) | |
Loss
per common share – basic and diluted |
$ |
(.04 |
) |
$ |
(.02 |
) |
$ |
(.13 |
) |
$ |
(.07 |
) |
ADVENTRX
PHARMACEUTICALS, INC.
(Formerly Biokeys Pharmaceuticals,
Inc.)
(A
Development Stage Enterprise)
Condensed
Consolidated Balance Sheets
December,31 |
December,31 |
||||||
2004 |
2003 |
||||||
Assets |
|||||||
Current
assets: |
|||||||
Cash
and cash equivalents |
$ |
13,032,263 |
$ |
4,226,397 |
|||
Accrued
interest income |
10,808
|
—
|
|||||
Prepaid
expenses |
115,144
|
28,376
|
|||||
Assets
available for sale |
108,000
|
—
|
|||||
Total
current assets |
13,266,215
|
4,254,773
|
|||||
Property
and equipment, net |
285,304
|
20,840
|
|||||
Other
assets |
57,268
|
7,743
|
|||||
Total
assets |
$ |
13,608,787 |
$ |
4,283,356 |
|||
Liabilities
and Shareholders’ Equity (Deficit) |
|||||||
Current
liabilities: |
|||||||
Accounts
payable and accrued liabilities |
$ |
1,161,081 |
$ |
90,243 |
|||
Accrued
salary and related taxes |
57,315
|
—
|
|||||
Accrued
dividends payable |
—
|
72,800
|
|||||
Total
liabilities |
1,218,396
|
163,043
|
|||||
Commitments
and contingencies |
—
|
—
|
|||||
Shareholders’
equity / (deficit): |
|||||||
Series
A cumulative convertible Preferred Stock, $0.01 par value; |
|||||||
Authorized
8,000 shares; issued and outstanding, 473 |
|||||||
shares
in 2003 (aggregate involuntary liquidation preference |
|||||||
$473,000
at December 31, 2003) |
—
|
4
|
|||||
Series
B convertible Preferred Stock, $0.01 par value; |
|||||||
Authorized
200,000 shares in 2003; issued and outstanding, |
|||||||
200,000
shares (no liquidation preference) |
—
|
2,000
|
|||||
Common
stock, $0.001 par value. Authorized 100,000,000 shares; |
|||||||
issued
53,834,237 in 2004 and issued and outstanding |
|||||||
42,491,708
shares in 2003 |
53,835
|
42,492
|
|||||
Additional
paid-in capital |
47,553,497
|
32,556,963
|
|||||
Deficit
accumulated during the development stage |
(35,182,194 |
) |
(28,481,146 |
) | |||
Treasury
stock, at cost |
(34,747 |
) |
—
|
||||
Total
shareholders’ equity / (deficit) |
12,390,391
|
4,120,313
|
|||||
Total
liabilities and shareholders’ equity / (deficit) |
$ |
13,608,787 |
$ |
4,283,356 |
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