ADVENTRX Announces 2005 First 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 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 co·lo·rec·tal adj. Relating to the colon and the rectum, or to the entire large bowel. colorectal pertaining to or of the nature of the colon and the rectum. and pancreatic cancers pancreatic cancer Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men. , we are moving 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) into late-stage trials for both these indications. This year we have received approvals to initiate a US 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 pivotal trial and a European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community Phase IIb international trial both 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. ," 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 pancreatic /pan·cre·at·ic/ (pan?kre-at´ik) pertaining to the pancreas. pancreatic pertaining to the pancreas. See also pancreatitis, diabetes mellitus, cystic pancreatic duct. 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 Thymidylate synthase is the enzyme used to generate thymidine monophosphate (dTMP), which is subsequently phosphorylated to thymidine triphosphate for use in DNA synthesis. (TS). CoFactor bypasses the chemical pathway required by leucovorin to deliver the active form of folate folate /fo·late/ (fo´lat) 1. the anionic form of folic acid. 2. more generally, any of a group of substances containing a form of pteroic acid conjugated with l-glutamic acid and having a variety of substitutions. , 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 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 and address 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. or resistance. 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 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. 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 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.
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
=============== ==============
|
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion