ADVENTRX Announces 2005 Second Quarter Financial Results.SAN DIEGO San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay. -- ADVENTRX Pharmaceuticals, Inc. (AMEX AMEX See: American Stock Exchange :ANX ANX Annex ANX Adventrx Pharmaceuticals (San Diego, CA) ANX Automotive Network Exchange (AIAG) ANX Advanced Network Exchange ANX Ascending Node Crossing (satellites) ) today announced financial results for the three and six months ended June 30, 2005. ADVENTRX reported a net loss of $3.3 million, or $0.06 per share, for the second quarter of 2005, compared with a net loss of $1.5 million, or $0.03 per share, for the second quarter of 2004. "In past several months, we have moved significantly closer to our corporate goal of introducing new anticancer anticancer, n a medicine or substance used to treat cancer. and antiviral antiviral /an·ti·vi·ral/ (-vi´ral) destroying viruses or suppressing their replication, or an agent that so acts. an·ti·vi·ral adj. treatments that improve the performance and safety of existing drugs," said Evan M. Levine, ADVENTRX president and chief executive officer. "With our lead drug candidate CoFactor cofactor An atom, organic molecule, or molecular group that is necessary for the catalytic activity (see catalysis) of many enzymes. A cofactor may be tightly bound to the protein portion of an enzyme and thus be an integral part of its functional structure, or it may (TM), we have reported favorable fa·vor·a·ble adj. 1. Advantageous; helpful: favorable winds. 2. Encouraging; propitious: a favorable diagnosis. 3. clinical results that further confirm this drug candidate as a viable replacement for leucovorin to improve 5-fluorouracil (5-FU) effectiveness while lowering toxicity. Additionally, we have initiated a Phase IIb trial and received clearance from the US Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) to begin a pivotal Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trial with CoFactor in metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. patients. Further, our preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. work with Thiovir(TM) indicates that this orally administered, broad spectrum antiviral drug antiviral drug, any of several drugs used to treat viral infections. The drugs act by interfering with a virus's ability to enter a host cell and replicate itself with the host cell's DNA. candidate shows potential promise as a more convenient, less toxic alternative to foscarnet foscarnet /fos·car·net/ (fos-kahr´net) a virostatic agent used as the sodium salt in the treatment of cytomegalovirus retinitis and herpes simplex in immunocompromised patients. for the treatment of opportunistic infections Opportunistic infections Infections that cause a disease only when the host's immune system is impaired. The classic opportunistic infection never leads to disease in the normal host. in HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. patients. "With the completion of our $20 million financing, we are well situated financially to move forward with our aggressive clinical development plans with CoFactor and further capitalize on Cap´i`tal`ize on` v. t. 1. To turn (an opportunity) to one's advantage; to take advantage of (a situation); to profit from; as, to capitalize on an opponent's mistakes s>. our drug development pipeline opportunities," added Mr. Levine. Second Quarter and First Half of 2005 Financial Review Research and development expenses for the second quarter of 2005 were $2.2 million, versus $773,000 for the second quarter of 2004. The increase for the 2005 second quarter was related primarily to expenses associated with the Company's clinical trials with CoFactor. General and administrative expenses for the 2005 second quarter were $1.1 million, compared with $746,000 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; and increased expenses associated with business development activities. For the six months ended June 30, 2005, net loss was $6.2 million, or $0.11 per share, compared with a net loss of $2.2 million, or $0.05 per share, for the same period in 2004. For the first six months of 2005, research and development expenses were $3.9 million, compared with $1.1 million first six months of 2004. General and administrative expenses for the first half of 2005 were $2.3 million, compared with $1.2 million for the same period in 2004. The Company reported that it expects research and development expenses to significantly increase from levels reported in the 2005 second quarter as it ramps up for a pivotal Phase III CoFactor clinical trial and continues patient enrollment in its Phase IIb CoFactor clinical trial. The timing of the increase in research and development expenses is directly related to the timing of the launch of the Phase III trial, and the amount of increase will be directly related to the success and speed in patient enrollment in these trials. The Company also expects that general and administrative expenses will increase measurably during the remainder of 2005 as it prepares for compliance with Section 404 of the Sarbanes-Oxley Act See SOX. . ADVENTRX reported cash and cash equivalents of approximately $8.1 million as of June 30, 2005, compared with $13.0 million as of December 31, 2004. In July, the Company announced the completion of a $20 million private placement of the Company's common stock and warrants. Funds from this transaction will be reflected on the Company's balance sheet in the third quarter ending September 30, 2005. 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 Drug Metabolism/Interactions Definition Drug metabolism is the process by which the body breaks down and converts medication into active chemical substances. Precautions Drugs can interact with other drugs, foods, and beverages. , toxicity, bioavailability bioavailability /bio·avail·a·bil·i·ty/ (bi?o-ah-val?ah-bil´i-te) the degree to which a drug or other substance becomes available to the target tissue after administration. bi·o·a·vail·a·bil·i·ty n. and resistance. The Company's lead compound, CoFactor, is a biomodulator of 5-FU, a widely used cancer chemotherapy. CoFactor met the primary endpoint for response and secondary endpoint for safety in an ongoing Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II . CoFactor is currently being tested with 5-FU in this US-based Phase II clinical trial and an EU-based Phase IIb clinical trial as a first line treatment of metastatic colorectal cancer. In addition, CoFactor has received clearance under a special protocol assessment from the US FDA to begin a Phase III pivotal clinical trial for metastatic colorectal cancer. More information can be found on the Company's Web site at www.adventrx.com. Forward-Looking Statement forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. This press release contains forward-looking statements within the meaning of the "safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. . 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-Q Form 10-Q See 10-Q. , 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.
ADVENTRX PHARMACEUTICALS, INC. AND SUBSIDIARY
(A Development Stage Enterprise)
Condensed Consolidated Statements of Operations
(unaudited)
Three months ended Six months ended
June 30, June 30,
------------------------ ------------------------
2005 2004 2005 2004
----------- ----------- ----------- -----------
Net sales $ -- $ -- $ -- $ --
Cost of goods sold -- -- -- --
----------- ----------- ----------- -----------
Gross margin -- -- -- --
Grant revenue -- -- -- --
Interest income 64,597 13,341 101,919 16,687
----------- ----------- ----------- -----------
64,597 13,341 101,919 16,687
----------- ----------- ----------- -----------
Operating expenses:
Research and
development 2,236,609 773,091 3,941,406 1,069,466
General and
administrative 1,123,577 745,838 2,273,910 1,160,220
Depreciation and
amortization 34,965 3,666 62,091 6,718
Impairment loss -
write off of
goodwill -- -- -- --
Interest expense -- -- -- --
Equity in loss of
investee -- -- -- --
----------- ----------- ----------- -----------
Total operating
expenses 3,395,151 1,522,595 6,277,407 2,236,404
----------- ----------- ----------- -----------
Loss before
cumulative effect
of change in
accounting
principle (3,330,554) (1,509,254) (6,175,488) (2,219,717)
Cumulative effect
of change in
accounting
principle -- -- -- --
----------- ----------- ----------- -----------
Net loss (3,330,554) (1,509,254) (6,175,488) (2,219,717)
Preferred stock
dividends -- -- -- --
----------- ----------- ----------- -----------
Net loss
applicable to
common stock $(3,330,554) $(1,509,254) $(6,175,488) $(2,219,717)
=========== =========== =========== ===========
Loss per common
share - basic
and diluted $ (.06) $ (.03) $ (.11) $ (.05)
=========== =========== =========== ===========
ADVENTRX PHARMACEUTICALS, INC. AND SUBSIDIARY
(A Development Stage Enterprise)
Condensed Consolidated Balance Sheets
June 30, December 31,
2005 2004
------------- --------------
(unaudited)
Assets
Current assets:
Cash and cash equivalents $ 8,102,824 $ 13,032,263
Accrued interest income -- 10,808
Prepaid expenses 471,335 115,144
Other current assets 3,138 --
Assets available for sale -- 108,000
------------- --------------
Total current assets 8,577,297 13,266,215
------------- --------------
Property and equipment, net 342,036 285,304
Other assets 58,387 57,268
------------- --------------
Total assets $ 8,977,720 $ 13,608,787
============= ==============
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 270,779 $ 532,327
Accrued liabilities 770,612 628,753
Accrued salary and related taxes 126,364 57,315
------------- --------------
Total current liabilities 1,167,755 1,218,396
Commitments and contingencies -- --
Shareholders' equity:
Common stock, $0.001 par value.
Authorized 100,000,000 shares; issued
55,046,086 shares in 2005 and
53,834,237 shares in 2004 55,047 53,835
Additional paid-in capital 49,147,347 47,553,497
Deficit accumulated during the
development stage (41,357,682) (35,182,194)
Treasury stock, 23,165 shares at cost (34,747) (34,747)
------------- --------------
Total shareholders' equity 7,809,965 12,390,391
------------- --------------
Total liabilities and
shareholders' equity $ 8,977,720 $ 13,608,787
============= ==============
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