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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
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): August 10, 2006
ADVENTRX Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware | 1-15803 | 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 August 10, 2006, ADVENTRX Pharmaceuticals, Inc. issued a press release announcing its financial
results for the quarter ended June 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: August 10, 2006 | By: | /s/ Evan M. Levine | ||
Name: | Evan M. Levine | |||
Title: | President and Chief Executive Officer |
Table of Contents
EXHIBIT 99.1
ADVENTRX ANNOUNCES 2006 SECOND QUARTER FINANCIAL RESULTS
SAN DIEGO August 10, 2006 ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced
financial results for the three months ended June 30, 2006.
For the three months ended June 30, 2006, net income was $2.8 million (which included a gain on the
fair market value of warrants of $18.0 million), or $0.03 per diluted share, compared with a net
loss of $3.3 million, or $(0.06) per share, for the same period in 2005, and net operating loss was
$15.2 million, including a one-time charge to in-process research and development of $10.4 million
related to the SD Pharmaceuticals acquisition.
One of the many highlights of the second quarter of 2006 is the merger with SD Pharmaceuticals, an
acquisition which provided ADVENTRX with numerous additional product development opportunities in
oncology and infectious disease, said Evan M. Levine, ADVENTRX president and chief executive
officer. We are analyzing regulatory and development strategies for most of these product
candidates, many of which we believe will qualify for bioequivalency development paths under
section 505(b)(2) of the Federal Food, Drug & Cosmetic Act and we believe could create numerous
growth opportunities for our organization.
Developments for our lead oncology drug, CoFactorâ, include an agreement by the FDA to a
special protocol assessment (SPA) for our Phase III pivotal clinical trial design and the
initiation in June of patient dosing for this trial. At the annual ASCO conference in June, we
announced an update to the results of the CoFactor Phase II clinical trial, including preliminary
median overall survival of 459 days or approximately 15.1 months for first line metastatic
colorectal cancer patients treated with CoFactor and 5-FU.
At the World Congress on Gastrointestinal Cancer in Barcelona, we presented pharmacokinetics data
which demonstrated that we can achieve significant plasma concentrations of CoFactor from a two
hour administration, suggesting that CoFactor may be suitable in an infusional regimen, which is
the standard 5-FU administration for metastatic colorectal cancer in Europe. At this same
conference, we presented encouraging new supplemental results from a follow-up evaluation of the 50
patients who completed the CoFactor plus 5-FU Phase II clinical trial. Median overall survival was
23.0 months for the 33 patients that received first and second line treatment. Second line
treatment was selected by each investigator and consisted of chemotherapy for 29 patients and
surgical resection for 4 patients. These second-line results are
encouraging and suggest
that CoFactor plus 5-FU may be a useful initial regimen in a sequential treatment strategy for
metastatic colorectal cancer.
In June, the data safety monitoring board (DSMB) supported the continuation of our CoFactor Phase
IIb clinical trial without modifications following a planned interim analysis of safety and
efficacy data. This clinical trial has now enrolled 93% of the expected total clinical enrollment
at sites in Europe and India.
With respect to our antiviral drug, Thiovirä, we announced additional positive preclinical
results at two scientific conferences. First, we presented synergistic activity of Thiovir with
zidovudine (AZT) against multiple HIV strains, but without synergistic toxicity in human cells.
Furthermore, Thiovir re-sensitized zidovudine-resistant HIV strains to zidovudine, a finding that
we believe has potentially important clinical implications. Additional results were presented
demonstrating broad spectrum activity of Thiovir against HIV-1 and HIV-2 and complex NRTI
(nucleoside reverse transcriptase inhibitor) and NNRTI (non-nucleoside reverse transcriptase
inhibitor)-resistant virus. Thiovir also demonstrated activity against multiple subtypes of
influenza B and influenza A, including a hybrid H5N1 avian influenza virus and was found to be
active against herpes simplex virus-1 (HSV-1) and HSV-2.
We believe our product portfolio is making progress and has helped us gain increasing recognition
within the investment community. This recognition is exemplified by our new membership in both the
Russell 3000â and Russell 2000â Indexes.
Second Quarter 2006 Financial Review
Research and development expenses for the second quarter of 2006 were $3.2 million, versus
$2.2 million for the second quarter of 2005. This increase was due primarily to increased costs of
the Companys Phase IIb clinical trial as patient enrollment continued, as well as increased
personnel costs due to new hires.
General and administrative expenses for the 2006 second quarter were $1.8 million, compared
with $1.1 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.
We recorded a gain on the fair value of warrants for the second quarter 2006 of $18.0 million.
This non-cash gain is related to the valuation of warrants that were issued in conjunction with a
financing in July 2005. The fair value was estimated to be $28.8 million at June 30, 2006, a
reduction of $18.0 million from the estimated value at March 31, 2006 of $46.7 million. Accounting
rules require the re-measurement of this non-cash expense at the end of each quarter .
In-process research and development expense for the second quarter 2006 was $10.4 million as a
result of our acquisition of SD Pharmaceuticals. A fair valuation of the intangible assets
acquired was completed in accordance with FAS 141/142 and it was determined that the entire
purchase price would be allocated to in-process research and development expense.
ADVENTRX reported cash, cash equivalents and short-term investments of approximately
$18.8 million as of June 30, 2006, compared with $22.6 million as of December 31, 2005. In
addition, subsequent to June 30, ADVENTRX received approximately $3.1 million in connection with the exercise of
certain warrants.
About ADVENTRX
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on introducing treatments for cancer and infectious disease 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.
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on introducing treatments for cancer and infectious disease 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.
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
(unaudited)
(A Development Stage Enterprise)
Condensed Consolidated Statements of Operations
(unaudited)
Three months ended June 30, | Six months ended June 30, | |||||||||||||||
2006 | 2005 | 2006 | 2005 | |||||||||||||
Interest income |
$ | 252,114 | $ | 64,597 | $ | 488,641 | $ | 101,919 | ||||||||
Total income |
252,114 | 64,597 | 488,641 | 101,919 | ||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
3,233,735 | 2,236,609 | 5,717,593 | 3,941,406 | ||||||||||||
General and administrative |
1,754,757 | 1,123,577 | 3,489,929 | 2,273,910 | ||||||||||||
Depreciation and
amortization |
41,089 | 34,965 | 78,202 | 62,091 | ||||||||||||
In process research and
development |
10,422,130 | | 10,422,130 | | ||||||||||||
Total operating expenses |
15,451,711 | 3,395,151 | 19,707,854 | 6,277,407 | ||||||||||||
Loss from operations |
(15,199,597 | ) | (3,330,554 | ) | (19,219,213 | ) | (6,175,488 | ) | ||||||||
Gain on fair value of
warrants |
17,963,311 | | 936,246 | | ||||||||||||
Net income (loss) |
$ | 2,763,714 | $ | (3,330,554 | ) | $ | (18,282,967 | ) | $ | (6,175,488 | ) | |||||
Net income (loss) per
common share: |
||||||||||||||||
Basic net
income (loss) per
share |
$ | .04 | $ | (.06 | ) | $ | (.26 | ) | $ | (.11 | ) | |||||
Diluted net
income (loss) per
share |
$ | .03 | $ | (.06 | ) | $ | (.26 | ) | $ | (.11 | ) | |||||
ADVENTRX PHARMACEUTICALS, INC. AND SUBSIDIARY
(A Development Stage Enterprise)
Condensed Consolidated Balance Sheets
(A Development Stage Enterprise)
Condensed Consolidated Balance Sheets
June 30, | December 31, | |||||||
2006 | 2005 | |||||||
(unaudited) | ||||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 17,601,928 | $ | 14,634,618 | ||||
Accrued interest income |
14,676 | 10,214 | ||||||
Prepaid expenses |
671,568 | 255,802 | ||||||
Other current assets |
6,701 | | ||||||
Short-term investments |
1,148,848 | 7,958,458 | ||||||
Total current assets |
19,443,721 | 22,859,092 | ||||||
Property and equipment, net |
417,813 | 407,544 | ||||||
Other assets |
315,970 | 355,137 | ||||||
Total assets |
$ | 20,177,504 | $ | 23,621,773 | ||||
Liabilities and Shareholders Deficiency |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 381,950 | $ | 593,228 | ||||
Accrued liabilities |
2,239,937 | 930,274 | ||||||
Accrued salary and related taxes |
211,179 | 173,398 | ||||||
Warrant liability |
28,760,165 | 29,696,411 | ||||||
Total current liabilities |
31,593,231 | 31,393,311 | ||||||
Long-term liabilities |
46,376 | 57,078 | ||||||
Total liabilities |
31,639,607 | 31,450,389 | ||||||
Commitments
and contingencies Temporary equity: |
||||||||
Common stock subject to continuing registration,
$.001 par value; 10,810,809 shares issued and
outstanding in 2006 and 2005, respectively |
| | ||||||
Shareholders deficiency: |
||||||||
Common stock, $0.001 par value. Authorized
200,000,000 shares; issued 61,495,727 shares in
2006 and 56,529,388 shares in 2005 |
72,330 | 67,364 | ||||||
Additional paid-in capital |
66,746,972 | 52,105,329 | ||||||
Accumulated other comprehensive gain (loss) |
1,149 | (1,722 | ) | |||||
Deficit accumulated during the development stage |
(78,247,807 | ) | (59,964,840 | ) | ||||
Treasury stock, 23,165 shares at cost |
(34,747 | ) | (34,747 | ) | ||||
Total shareholders deficiency |
(11,462,103 | ) | (7,828,616 | ) | ||||
Total liabilities and shareholders deficiency |
$ | 20,177,504 | $ | 23,621,773 | ||||
###