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Filing
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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
TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) May 10, 2006
ADVENTRX Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware (State or other jurisdiction of incorporation) |
1-15803 (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)
San Diego, California 92121
(Address of principal executive offices) (Zip Code)
(858) 552-0866
(Companys telephone number, including area code)
(Companys telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
(Former name or former address, if changed since last report)
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. | ||||||||
SIGNATURES | ||||||||
EXHIBIT INDEX | ||||||||
Exhibit 99.1 |
Table of Contents
Item 2.02. Results of Operations and Financial Condition
On May 10, 2006, the Company announced financial results for the three months ended
March 31, 2006.
The press release issued by the Company on May 10, 2006 with respect to this matter is
included with this report as an exhibit.
Item 9.01. Financial Statements and Exhibits.
(d) | The exhibit list required by this item is incorporated by reference to the Exhibit Index filed as part of this report. |
Table of Contents
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. |
||||
May 16, 2006 | By: | /s/ Carrie E. Carlander | ||
Name: | Carrie E. Carlander | |||
Title: | Chief Financial Officer, Senior Vice President Finance, and Treasurer |
Table of Contents
Exhibit 99.1
ADVENTRX ANNOUNCES 2006 FIRST QUARTER FINANCIAL RESULTS
SAN DIEGO May 10, 2006 ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced financial
results for the three months ended March 31, 2006.
First Quarter 2006 Financial Review
Research and development expenses for the first quarter of 2006 were $2.5 million, versus $1.7
million for the first quarter of 2005. This increase was due primarily to increased costs of the
Companys Phase IIb clinical trial as patient enrollment crossed the 50% threshold as well as
increased personnel costs due to new hires.
General and administrative expenses for the 2006 first quarter were $1.7 million, compared with
$1.2 million for the same period in 2005. This increase is due primarily to employee and
non-employee stock-based compensation charges and continuing SOX 404 compliance costs.
Warrant expense for the first quarter 2006 was $17.0 million. This non-cash expense is related to
the valuation of warrants that were issued in conjunction with a financing in July 2005.
Accounting rules require the re-measurement of this non-cash expense at the end of each quarter.
For the three months ended March 31, 2006, net loss was $21.0 million, or $0.31 per share, compared
with a net loss of $2.8 million, or $0.05 per share, for the same period in 2005. Pro-forma net
loss excluding warrant non-cash expense of $17.0 million was $4.0 million, or $0.06 per share.
ADVENTRX reported cash, cash equivalents and short-term investments of approximately $22.0 million
as of March 31, 2006, compared with $10.5 million as of March 31, 2005.
The first quarter of 2006 was one of continued progress for ADVENTRX, said Evan M. Levine,
ADVENTRX president and chief executive officer. In January at the ASCO GI Cancers Conference we
announced results from our CoFactor® Phase II clinical trial, from an independent radiology
assessment showing 35% tumor response and 85% overall clinical benefit in metastatic colorectal
cancer patients treated first-line with CoFactor plus 5-fluorouracil (5-FU). We also reported no
grade 3 or 4 drug-related toxicities and time-to-tumor progression of 163 days in the Phase II
trial. We were very pleased with these results that give us added confidence as we move forward
with the CoFactor Phase III clinical trial which is planned to begin in Q2 this year. During Q1 we
also announced that our CoFactor Phase IIb trial had surpassed the 50% enrollment milestone at
clinical sites in Europe and India and that we were planning an additional CoFactor clinical trial
in third-line treatment of breast cancer.
In the infectious diseases arena, we announced that our antiviral drug, Thiovir demonstrated
activity against influenza A and a chimeric H5N1 avian influenza virus in preclinical tests. Full
results from these and other preclinical tests using Thiovir against other viruses will be
presented in June at the 14th International Symposium on HIV and Emerging Infectious
Diseases. We presented results in March showing Thiovir synergy with zidovudine or AZT suggesting
that this combination may require lower dosages of each drug when used in combination, without
additional toxicity. We currently plan to file an investigational new drug application (IND) for
Thiovir in the third quarter of this year to conduct a Phase I/II clinical trial in HIV/AIDS
patients.
Positive preclinical results were presented at the annual AACR meeting showing reduced vein
toxicity, edema and erythema from our novel vinorelbine emulsion drug (ANX-530) compared with the
reference vinorelbine drug following repeated intravenous injections. We currently plan to file an
IND for ANX-530 in Q3 of this year.
Finally and importantly, at the beginning of Q2 2006, we announced a definitive merger agreement
with SD Pharmaceuticals (SD Pharma) in a deal that closed in April. The acquisition of SD Pharma
gives us world rights, excluding rights in China, Hong Kong, Macau and Taiwan, to eight cancer and
infectious disease compounds. We believe many of these compounds will qualify for bioequivalency
development paths under section 505(b)(2) of the
Federal Food, Drug & Cosmetic Act and will create numerous near-term growth opportunities for our
organization.
About ADVENTRX
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on
introducing treatments for cancer and infectious diseases that surpass the performance and safety
of existing drugs, by addressing significant problems such as drug metabolism, toxicity,
bioavailability and resistance. More information can be found on the Companys 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, regarding ADVENTRX. Such
statements are made based on managements 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 regarding ADVENTRX, see the section
titled Risk Factors in ADVENTRXs last annual report on Form 10-K and its Quarterly Reports on
Form 10-Q, as well as other reports that ADVENTRX files from time to time with the Securities and
Exchange Commission. All forward-looking statements regarding ADVENTRX are qualified in their
entirety by this cautionary statement. ADVENTRX undertakes no obligation to release publicly any
revisions to forward-looking statements to reflect events or circumstances which occur after the
date hereof.
Contact:
ADVENTRX Pharmaceuticals
Andrea Lynn
858-552-0866
ADVENTRX Pharmaceuticals
Andrea Lynn
858-552-0866
[Tables to Follow]
ADVENTRX PHARMACEUTICALS, INC. AND SUBSIDIARY
(A Development Stage Enterprise)
Condensed Consolidated Statements of Operations
(A Development Stage Enterprise)
Condensed Consolidated Statements of Operations
Three months ended March 31, | ||||||||
2006 | 2005 | |||||||
Interest income |
$ | 236,527 | $ | 37,322 | ||||
Operating expenses: |
||||||||
Research and development |
2,483,858 | 1,704,797 | ||||||
General and administrative |
1,735,172 | 1,150,033 | ||||||
Depreciation and amortization |
37,113 | 27,126 | ||||||
Interest expense |
| 300 | ||||||
Total operating expenses |
4,256,143 | 2,882,256 | ||||||
Loss from operations |
(4,019,616 | ) | (2,844,934 | ) | ||||
Gain (loss) on fair value of warrants |
(17,027,065 | ) | | |||||
Net loss |
$ | (21,046,681 | ) | $ | (2,844,934 | ) | ||
Loss per common share basic and
diluted |
$ | (0.31 | ) | $ | (0.05 | ) | ||
Weighted average shares outstanding-
basic and diluted |
67,976,352 | 53,967,933 | ||||||
ADVENTRX PHARMACEUTICALS, INC. AND SUBSIDIARY
Consolidated Balance Sheets
Consolidated Balance Sheets
March 31, | December 31, | |||||||
2006 | 2005 | |||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 16,819,293 | $ | 14,634,618 | ||||
Accrued interest income |
13,773 | 10,214 | ||||||
Prepaid expenses |
291,052 | 255,802 | ||||||
Short-term investments |
5,194,703 | 7,958,458 | ||||||
Total current assets |
22,318,821 | 22,859,092 | ||||||
Property and equipment, net |
389,102 | 407,544 | ||||||
Other assets |
335,554 | 355,137 | ||||||
Total assets |
$ | 23,043,477 | $ | 23,621,773 | ||||
Liabilities and Shareholders Equity |
||||||||
Current liabilities: |
||||||||
Accounts payable |
694,363 | 593,228 | ||||||
Accrued liabilities |
1,276,202 | 930,274 | ||||||
Accrued salary and related taxes |
237,868 | 173,398 | ||||||
Warrant liability |
46,723,476 | 29,696,411 | ||||||
Total current liabilities |
48,931,909 | 31,393,311 | ||||||
Other long-term liabilities |
57,078 | 57,078 | ||||||
Total liabilities |
48,988,987 | 31,450,389 | ||||||
Committments and contingencies |
| | ||||||
Temporary equity: |
||||||||
Common stock subject to continuing registration,
$.001 par value; 10,810,809 shares issued and outstanding |
| | ||||||
Shareholders equity/(deficit): |
||||||||
Common stock, $0.001 par value; authorized 200,000,000,
issued 58,317,667 in 2006 and 56,529,388 shares in 2005 |
69,152 | 67,364 | ||||||
Additional paid-in capital |
55,034,292 | 52,105,329 | ||||||
Deficit accumulated during the development stage |
(81,011,521 | ) | (59,964,840 | ) | ||||
Accumulated other comprehensive gains (losses) |
(2,686 | ) | (1,722 | ) | ||||
Treasury stock, 23,165 shares at cost |
(34,747 | ) | (34,747 | ) | ||||
Total shareholders equity |
(25,945,510 | ) | (7,828,616 | ) | ||||
Total liabilities and shareholders deficiency |
$ | 23,043,477 | $ | 23,621,773 | ||||
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