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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) May
13, 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
2.02. Results of Operations and Financial Condition.
On May
13, 2005, the Company announced its 2005 First Quarter Financial Results.
The press
release issued by the Company on May 13, 2005 with respect to this
matter is included with this report as an
exhibit.
Item
8.01. Other Events.
On May
13, 2005, the Company announced preliminary Phase II trial results with
CoFactor™ in metastatic colorectal cancer.
The press
release issued by the Company on May 13, 2005 with respect to this
matter is included with this report as an exhibit.
Item
9.01. Financial Statements and Exhibits.
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 | ||
May
13, 2005 |
EXHIBIT
INDEX
Exhibit
|
Description
|
99.1
|
Press
Release of the Company dated May 13, 2005.
|
99.2
|
Press
Release of the Company dated May 13, 2005.
|
Exhibit
99.1
ADVENTRX
ANNOUNCES 2005 FIRST QUARTER FINANCIAL RESULTS
SAN
DIEGO - May 13, 2005 -
ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced financial results for
the three months ended March 31, 2005.
For the
first quarter of 2005, ADVENTRX reported a net loss of $2.8 million, or $0.05
per share, compared with a net loss of $710,000, or $0.02 per share, for the
first quarter of 2004.
“Building
on our ability to demonstrate clinical benefit in colorectal and pancreatic
cancers, we are moving Co-Factor™ into late-stage trials for both these
indications. This year we have received approvals to initiate a US Phase III
pivotal trial and a European Union Phase IIb international trial both in
metastatic colorectal cancer,” said Evan M. Levine, ADVENTRX president and chief
executive officer. “Later in the current quarter, we plan to file for European
clearance to initiate a Phase III pivotal trial in pancreatic cancer. We expect
to be enrolling patients in all three late-stage CoFactor trials by year
end.”
First
Quarter Financial Review
Research
and development (R&D) expenses for the first quarter of 2005 were $1.7
million, compared with $296,000 for the first quarter of 2004. The increase in
R&D expenses for the 2005 first quarter was due primarily to clinical
expenses associated with the Company’s ongoing Phase II CoFactor trial. General
and administrative expenses for the 2005 first quarter were $1.2 million,
compared with $414,000 for the same period in 2004. This increase was due
primarily to the hiring of additional personnel in the finance and marketing,
and business development departments; increased directors and officers insurance
premiums; increased legal fees; payments for settlements of certain disputes;
and increased expenses associated with business development
activities.
ADVENTRX
reported cash and cash equivalents of approximately $10.5 million as of March
31, 2005, compared with $13.0 million as of December 31, 2004. This decrease was
due primarily to the use of cash to fund R&D and general and administrative
expenses.
About
CoFactor
CoFactor
(ANX-510) 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. In comparison to leucovorin, CoFactor creates more stable
binding of the active form of 5-FU, FdUMP, to the target enzyme, thymidylate
synthase (TS). CoFactor bypasses the chemical pathway required by leucovorin to
deliver the active form of folate, allowing 5-FU to work more effectively. This
improves 5-FU performance and lowers toxicity. ADVENTRX is the exclusive
licensee of this compound. More information on CoFactor can be found at
http://www.adventrx.com/products/antic_cofactor.htm.
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 and safety of existing drugs and address significant
problems such as drug metabolism, toxicity, bioavailability or 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 annual report on Form
10-KSB, 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
[Tables
to Follow]
ADVENTRX
PHARMACEUTICALS, INC. | |||||||
(Formerly
Biokeys Pharmaceuticals, Inc.) | |||||||
(A
Development Stage Enterprise) | |||||||
Condensed
Consolidated Statements of Operations | |||||||
(unaudited) | |||||||
Three
months ended March 31, |
|||||||
2005 |
2004 |
||||||
Net
sales |
$ |
— |
$ |
— |
|||
Cost
of goods sold |
—
|
—
|
|||||
Gross
margin |
—
|
—
|
|||||
Grant
revenue |
—
|
—
|
|||||
Interest
income |
37,322
|
3,346
|
|||||
37,322
|
3,346
|
||||||
Operating
expenses: |
|||||||
Research
and development |
1,704,797
|
296,375
|
|||||
General
and administrative |
1,150,033
|
414,382
|
|||||
Depreciation
and amortization |
27,126
|
3,052
|
|||||
Impairment
loss – write off of goodwill |
—
|
—
|
|||||
Interest
expense |
300
|
—
|
|||||
Equity
in loss of investee |
—
|
—
|
|||||
Total
operating expenses |
2,882,256
|
713,809
|
|||||
Loss
before cumulative effect of |
|||||||
change
in accounting principle |
(2,844,934 |
) |
(710,463 |
) | |||
Cumulative
effect of change in accounting |
|||||||
principle
|
—
|
—
|
|||||
Net
loss |
(2,844,934 |
) |
(710,463 |
) | |||
Preferred
stock dividends |
—
|
—
|
|||||
Net
loss applicable to common stock |
$ |
(2,844,934 |
) |
$ |
(710,463 |
) | |
Loss
per common share – basic and |
|||||||
diluted |
$ |
(.05 |
) |
$ |
(.02 |
) |
ADVENTRX
PHARMACEUTICALS, INC. |
|||||||
(Formerly
Biokeys Pharmaceuticals, Inc.) | |||||||
(A
Development Stage Enterprise) | |||||||
Condensed
Consolidated Balance Sheets | |||||||
March,31 |
December,31 |
||||||
|
|
2005 |
|
2004 |
| ||
|
(unaudited) |
||||||
Assets |
|||||||
Current
assets: |
|||||||
Cash
and cash equivalents |
$ |
10,532,678 |
$ |
13,032,263 |
|||
Accrued
interest income |
—
|
10,808
|
|||||
Prepaid
expenses |
54,881
|
115,144
|
|||||
Other
current assets |
27,392
|
—
|
|||||
Assets
available for sale |
—
|
108,000
|
|||||
Total
current assets |
10,614,951
|
13,266,215
|
|||||
Property
and equipment, net |
290,482
|
285,304
|
|||||
Other
assets |
53,012
|
57,268
|
|||||
Total
assets |
$ |
10,958,445 |
$ |
13,608,787 |
|||
Liabilities
and Shareholders’ Equity |
|||||||
Current
liabilities: |
|||||||
Accounts
payable |
$ |
970,324 |
$ |
532,327 |
|||
Accrued
liabilities |
102,392
|
628,754
|
|||||
Accrued
salary and related taxes |
88,796
|
57,315
|
|||||
Total
current liabilities |
1,161,512
|
1,218,396
|
|||||
Commitments
and contingencies |
|||||||
Shareholders’
equity: |
|||||||
Common
stock, $0.001 par value. Authorized 100,000,000 shares; |
|||||||
issued
54,037,987 shares in 2005 and 53,834,237 shares in 2004 |
54,039
|
53,835
|
|||||
Additional
paid-in capital |
47,804,769
|
47,553,497
|
|||||
Deficit
accumulated during the development stage |
(38,027,128 |
) |
(35,182,194 |
) | |||
Treasury
stock: 23,165 shares at cost |
(34,747 |
) |
(34,747 |
) | |||
Total
shareholders’ equity |
9,796,933
|
12,390,391
|
|||||
Total
liabilities and shareholders’ equity |
$ |
10,958,445 |
$ |
13,608,787 |
# # #
Exhibit
99.2
ADVENTRX
REPORTS POSITIVE PRELIMINARY PHASE II TRIAL RESULTS WITH COFACTOR IN METASTATIC
COLORECTAL CANCER
DATA
SHOW INCREASED RESPONSE RATE AND NO GRADE 3/4 GASTROINTESTINAL OR HEMATOLOGICAL
TOXICITY
SAN
DIEGO - May 13, 2005 -
ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced a 63% overall
clinical benefit and a 38% objective response rate in measurable patients
treated with CoFactor™ and 5-fluorouracil (5-FU) as a first-line treatment of
metastatic colorectal cancer in its Phase II trial. Furthermore, patients
enrolled in this trial have exhibited no grade 3 or 4 gastrointestinal or
hematological toxicities as determined in accordance with the National Cancer
Institute’s Common Terminology Criteria for Adverse Events grading system.
Patients continue to be followed for time-to-tumor progression and overall
survival. Of the 50 patients enrolled in the trial, 48 are available for tumor
response assessment and 44 have been evaluated for tumor response as of May 13.
ADVENTRX currently plans to announce response data on all patients in June at
the World Congress on Gastrointestinal Cancer in Barcelona, Spain and final
results, including time-to-tumor-progression and early survival, from this trial
in the fourth quarter of this year.
“To date
our Phase II trial with CoFactor and 5-FU has demonstrated objective response
rates of 38%. This is more than double the rate of 11-17% historically observed
in clinical trials treating metastatic colorectal cancer patients with
leucovorin and 5-FU, but with none of the typical grade 3 or 4 toxicities” said
Evan M. Levine, president and CEO for ADVENTRX. “These results suggest that
CoFactor increases the potency of 5-FU, while lowering toxicity compared with
5-FU/leucovorin treatment regimens. Based in part on these and earlier positive
Phase II CoFactor data, we have received clearance under a Special Protocol
Assessment (SPA) from the US Food and Drug Administration to begin a Phase III
pivotal trial and clearance in the United Kingdom to begin an international
Phase IIb trial using CoFactor and 5-FU as a first line combination therapy in
metastatic colorectal cancer. We plan to initiate both of these trials this
year.”
The Phase
II clinical trial is an open label, single arm Simon 2 stage study design to
assess the safety and efficacy of CoFactor plus 5-FU as a first line treatment
of metastatic colorectal cancer. CoFactor is ADVENTRX’s biomodulator designed to
enhance the effects of the widely used cancer drug, 5-FU.
Available
objective response data from the Phase II trial showed 38% or 18 patients
responded to treatment with CoFactor and 5-FU, surpassing the trial’s response
rate objective of 25%. To date, 12 patients have exhibited stable disease and 14
have progressive disease. World Health Organization criteria were used to define
response as follows: complete response is a complete disappearance of the tumor;
partial response is at least a 50% reduction in total tumor size; stable disease
is less than a 50% reduction in total tumor size; and progressive disease is at
least a 25% increase in tumor size at the end of the treatment cycle, as
measured by CT or MRI scans. Objective response is defined as all patients
having complete or partial responses, whose tumor measurements are confirmed by
MRI or CT scan by repeat assessment performed no less than four weeks after the
criteria for response is first met. The primary endpoint for the study,
objective response, was evaluated at the completion of two cycles at week 16
with the exception of those patients that progressed as established by
radiological assessment at the end of the first cycle (eight weeks). Clinical
benefit is defined as tumor response or stable disease following study therapy.
Other efficacy endpoints still being evaluated are time-to-tumor-progression and
overall survival.
Safety
data is available for all 50 patients. The clinical trial’s treatment regimen of
CoFactor plus 5-FU (COFU) was well tolerated, with no grade 3 or 4
gastrointestinal or hematological toxicities reported to date. The most common
adverse events (AEs) were diarrhea, nausea and vomiting, none of which were
grade 3 or 4. There was one additional adverse event, a single case of grade 3
watery eye.
Selected
preliminary results of ADVENTRX’s Phase II trial were published in the American
Society of Clinical Oncology (ASCO) 2005 Annual Meeting Proceedings (abstract
#3692). This abstract is available via ADVENTRX’s Web site at
www.adventrx.com.
ADVENTRX
recently received clearance in the US under an SPA to begin a Phase III pivotal
study of CoFactor in metastatic colorectal cancer. The Company also received
clearance in the United Kingdom to begin an international Phase IIb trial with
CoFactor and 5-FU in metastatic colorectal cancer. The Company plans to file in
the first half of this year for clearance to initiate an EU-based Phase III
CoFactor study in pancreatic cancer.
About
the Phase II COFU trial
Patients
enrolled in this trial are age 18 and older with ECOG 0-2 and measurable
metastatic colorectal cancer, with or without adjuvant 5-FU/leucovorin,
irinotecan, or oxaliplatin, but no prior chemotherapy for metastatic disease.
Patients may receive more than two cycles each consisting of CoFactor 60
mg/m2 and 5-FU
450 mg/m2 (weekly
IV bolus) for six consecutive weeks, followed by a 14 day rest period, which is
defined as a cycle. Pre-established response criteria are greater than four
responders of 23 patients for stage one, and greater than 12 responders of 48
patients for the full trial. The median age of patients was 65.5 (range 42-86),
and mean number of doses was 10.2 (range 1-24). The clinical response is
evaluated at the completion of two consecutive cycles. The trial is being
conducted in the US and Europe under a US investigational new drug application
(IND).
About
CoFactor
CoFactor
(ANX-510) is a folate-based biomodulator drug developed to enhance the activity
of the widely used cancer chemotherapeutic, 5-FU. 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. In comparison to leucovorin, CoFactor creates more stable binding of the
active form of 5-FU, FdUMP, to the target enzyme, thymidylate synthase (TS).
CoFactor bypasses the chemical pathway required by leucovorin to deliver the
active form of folate, allowing 5-FU to work more effectively. This improves
5-FU performance and lowers toxicity. ADVENTRX is the exclusive licensee of this
compound. More information on CoFactor can be found at http://www.adventrx.com/products/antic_cofactor.htm.
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 and safety of existing drugs, by addressing significant
problems such as drug metabolism, toxicity, bioavailability or 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 annual report on Form
10-KSB, 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
Media
Contact:
Lippert/Heilshorn
& Associates
Mark
Stuart (mstuart@lhai.com)
310-691-7116 |
###