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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 7, 2007 |
ADVENTRX Pharmaceuticals, Inc.
__________________________________________
(Exact name of registrant as specified in its charter)
Delaware | 001-32157 | 84-1318182 |
_____________________ (State or other jurisdiction |
_____________ (Commission |
______________ (I.R.S. Employer |
of incorporation) | File Number) | Identification No.) |
6725 Mesa Ridge Road, Suite 100, San Diego, California | 92121 | |
_________________________________ (Address of principal executive offices) |
___________ (Zip Code) |
Registrants telephone number, including area code: | 858-552-0866 |
Not Applicable
______________________________________________
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:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02 Results of Operations and Financial Condition.
On May 7, 2007, ADVENTRX Pharmaceuticals, Inc. issued a press release announcing its financial results for the three-month period ended March 31, 2007. 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.
The information set forth under Item 2.02 and in Exhibit 99.1 is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and is not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
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 7, 2007 | By: |
/s/ Evan M. Levine
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Name: Evan M. Levine | ||||
Title: Chief Executive Officer |
Exhibit Index
Exhibit No. | Description | |
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99.1
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Press Release, dated May 7, 2007 |
ADVENTRX PHARMACEUTICALS REPORTS FIRST QUARTER 2007 FINANCIAL RESULTS
Conference call scheduled for 1:30 p.m. (Pacific); simultaneous webcast at www.adventrx.com
SAN DIEGO, May 7, 2007 ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) a biopharmaceutical research and development company focused on commercializing proprietary product candidates for the treatment of cancer and infectious diseases, today announced financial results for the three months ended March 31, 2007. ADVENTRXs net loss was $5.1 million, or $0.06 per share for the three months ended March 31, 2007, compared to a net loss of $4.0 million, or $0.06 per share, for the same period in 2006.
ADVENTRX has expanded its product candidate portfolio substantially over the past year and is rapidly advancing its product candidates into the clinic, stated Evan M. Levine, chief executive officer of ADVENTRX. Depending on preclinical results and anticipated discussions with the FDA, we may have up to five product candidates in clinical development by the end of the year. In the interim, we look forward to announcing results of our 300-patient Phase 2b clinical trial of CoFactor for the treatment of metastatic colorectal cancer and results from our marketing-enabling study of ANX-530 later this year.
First Quarter 2007 Operating Results
Research and development, or R&D, expenses increased by $901,000, or 36%, to $3.4 million for the
three months ended March 31, 2007 from $2.5 million for the same period a year ago. The increase in
R&D expenses was primarily due to a $377,000 increase related to pre-clinical development of
ANX-530 (vinorelbine emulsion) and preclinical development of ANX-201 (thiophosphonoformate), and a
$390,000 increase in personnel and employee-related costs. R&D expenses for the three months ended
March 31, 2007 included $254,000 in non-cash, share-based compensation expense, compared to
$133,000 for the same period a year ago.
Selling, general and administrative, or SG&A, expenses increased by $1.1 million, or 62%, to $2.8 million for the three months ended March 31, 2007 from $1.7 million for the same period a year ago. The increase in SG&A expenses was primarily due to a $252,000 increase in legal fees related to patent costs, a $179,000 increase in market research for our product candidates, and a $472,000 increase in personnel and employee-related costs. SG&A expenses for the three months ended March 31, 2007 included $391,000 in non-cash, share-based compensation expense, compared to $495,000 for the same period a year ago.
Revenue of $500,000 for the three months ended March 31, 2007 represented a license fee earned from licensing ANX-211 (ZANAFLU® in the U.S.) to Theragenex, compared to no revenue for the comparable period in 2006. ADVENTRX expects that Theragenexs subsidiary, TRx Pharma, will launch ZANAFLU during the 2007 cold and influenza season. Interest income amounted to $622,000 for the three months ended March 31, 2007, compared to $237,000 for the same period a year ago.
Effective January 1, 2007, the Company adopted FASB Staff Position on No. EITF 00-19-2, Accounting for Registration Payment Arrangements, or FSP EITF 00-19-2. Pursuant to FSP EITF 00-19-2, the Company determined that no contingent liability was required to be recognized as of March 31, 2007 relating to a class of warrants issued in July 2005 that contained a registration payment arrangement, and accordingly, the carrying amount of the warrant liability that had been reported in previous periods was eliminated. In applying the new method retrospectively, the comparative financial statements of prior periods have been adjusted to eliminate the fair value of the warrant liability.
Balance Sheet Highlights
As of March 31, 2007, the Company had cash, cash equivalents and investments in securities totaling
$47.4 million, including cash and cash equivalents of $21.0 million and short-term investments in
securities of $26.4 million. Stockholders equity amounted to $45.8 million as of March 31, 2007.
Product and Pipeline Update
Recent activities of the Company include the following:
| Continuation of patient recruitment in the Companys 1,200-patient Phase 3 pivotal clinical trial of ANX-510, or CoFactor, for the treatment of metastatic colorectal cancer. The Company anticipates completing enrollment in 2008. |
| Announcement of positive results from a multi-drug treatment regimen including CoFactor at the American Association for Cancer Research (AACR) Annual Meeting. |
| Continuation of patient recruitment in the Companys 31-patient Phase 2 clinical trial of CoFactor for the treatment of advanced breast cancer. The Company anticipates completing enrollment by the end of 2007. |
| Continuation of patient recruitment in a 28-patient marketing enabling study of ANX-530 (vinorelbine emulsion), a chemotherapy drug used alone or in combination with other drugs to treat non-small cell lung cancer. The U.S. Food and Drug Administration accepted our Investigational New Drug Application in December 2006. The Company expects to complete the study in 2007 and, if it demonstrates bioequivalence with the currently marketed product, Navelbine® (vinorelbine tartrate), submit a New Drug Application by the end of the year. |
| Presentation of preclinical results demonstrating synergistic activity against human and avian influenza (bird flu) viruses when combining ANX-201 with Tamiflu® (oseltamivir phosphate). Preclinical development of ANX-201 (thiophosphonoformate) for the treatment of HIV continues and could progress to Phase 1/2 clinical development in 2007. An abstract was accepted for presentation at the International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention. |
| Presentation of positive results from preclinical testing of ANX-514 (docetaxel emulsion), a chemotherapy product candidate, in a well-recognized animal model. Study results indicated bioequivalent pharmacokinetics with a reduced risk of hypersensitivity reactions with ANX-514, as compared to the currently marketed product, Taxotere® (docetaxel). The Company currently plans to seek guidance from the FDA with respect to the appropriateness of a Section 505(b)(2) NDA regulatory path for ANX-514, and pending agreement on clinical protocol design with the FDA, initiate a marketing-enabling clinical trial of ANX-514 in 2007. |
Conference Call and Webcast
Management will host a conference call with a simultaneous webcast that will take place on Monday,
May 7 at 1:30 P.M. Pacific/4:30 P.M. Eastern to discuss the first quarter of 2007. Evan M. Levine,
Chief Executive Officer, and Gregory P. Hanson, Senior Vice President and Chief Financial Officer,
are scheduled to lead the call and will be joined by other members of the Companys senior
management team. The webcast will be available live via the Internet by accessing
ADVENTRXs web site at www.adventrx.com under Investors or by telephone at (877)
502-9274 (domestic) or (913) 981-5584 (international). Replays of the webcast will be available for
30 days, and a phone replay will be available through June 7, 2007 by dialing 888-203-1112 and
entering the passcode 4320902.
About ADVENTRX Pharmaceuticals
ADVENTRX is a biopharmaceutical research and development company focused on commercializing product
candidates for the treatment of cancer and infectious diseases. The Company seeks to improve the
performance and safety of existing therapeutic products by addressing significant problems such as
drug metabolism, bioavailability, excessive toxicity and treatment resistance. ADVENTRXs lead
product candidate, ANX-510 (CoFactor®), is in pivotal Phase 3 and Phase 2b clinical trials for the
treatment of metastatic colorectal cancer, as well as in a Phase 2 clinical trial for the treatment
of advanced breast cancer. The Companys business is in the development stage; it has not yet
marketed any products or generated any significant revenue. More information can be found on
ADVENTRXs web site at www.adventrx.com.
Forward Looking Statements
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 and assumptions that, if they
materialize or do not prove to be accurate, could cause ADVENTRXs results to differ materially
from historical results or those expressed or implied by such forward-looking statements. These
risks and uncertainties 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 ability to timely enroll subjects in ADVENTRXs current and anticipated clinical
trials; the timing and success of 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; the uncertain process of seeking regulatory approval; other difficulties or delays in
developing, testing, manufacturing and marketing of CoFactor and 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; adverse side effects or inadequate
therapeutic efficacy of CoFactor or ADVENTRXs other product candidates; the risk that preclinical
results are not indicative of the success of subsequent clinical trials and that products will not
perform as preclinical and clinical data suggest or as otherwise anticipated; 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. 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.
Contacts:
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Investors ADVENTRX Pharmaceuticals, Inc. Ioana C. Hone 1-858-552-0866 |
Media WeissComm Partners Amy Martini 1-212-301-7233 |
[Tables to Follow]
ADVENTRX Pharmaceuticals, Inc. and Subsidiaries | ||||||||
(A Development Stage Enterprise) | ||||||||
Summary Condensed Consolidated Financial Information | ||||||||
(In 000s except for per share data) | ||||||||
Consolidated Statement of Operations Data: |
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Quarters Ended March 31, |
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2007 | 2006 | |||||||
(Unaudited) |
(Unaudited) |
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Revenues |
$ | 500 | $ | | ||||
Operating expenses: |
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Research and development |
3,385 | 2,484 | ||||||
Selling, general and administrative |
2,809 | 1,735 | ||||||
Depreciation and amortization |
52 | 37 | ||||||
Total operating expenses |
6,246 | 4,256 | ||||||
Loss from operations |
(5,746 | ) | (4,256 | ) | ||||
Interest income |
622 | 236 | ||||||
Loss before income taxes |
(5,124 | ) | (4,020 | ) | ||||
Provision for income taxes |
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Net loss |
$ | (5,124 | ) | $ | (4,020 | ) | ||
Net loss per share basic and diluted |
$ | (0.06 | ) | $ | (0.06 | ) | ||
Weighted average shares basic and diluted |
89,677 | 67,976 |
Balance Sheet Data: |
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March 31, 2007 | December 31, 2006 | |||||||
(Unaudited) |
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Total cash and investments in securities |
$ | 47,440 | $ | 51,745 | ||||
Net working capital |
45,401 | 49,889 | ||||||
Total assets |
48,630 | 52,798 | ||||||
Total liabilities |
2,814 | 2,484 | ||||||
Stockholders equity |
45,816 | 50,314 |