ADVENTRX Announces 2004 Fourth Quarter and Full Year 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. -- Please replace the release dated March 31, 2005, with the following corrected version which reflects ADVENTRX' reallocation Noun 1. reallocation - a share that has been allocated again allocation, allotment - a share set aside for a specific purpose 2. reallocation of expenses for the 2004 and 2003 fourth quarters with no impact on net loss. The corrected release reads: ADVENTRX ANNOUNCES 2004 FOURTH QUARTER AND FULL YEAR FINANCIAL RESULTS ADVENTRX Pharmaceuticals, Inc. (Amex: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 12 months ended December 31, 2004. For the fourth quarter of 2004, ADVENTRX reported a net loss of $2.4 million, or $0.04 per share, compared with a net loss of $815,000, or $0.02 per share, for the fourth quarter of 2003. For the year ended December 31, 2004, net loss was $6.7 million, or $0.13 per share, compared with a net loss of $2.4 million, or $0.07 per share, for the same period in 2003. "Our most significant accomplishment during the past year was hitting the primary clinical endpoint In a research trial, a clinical endpoint refers to a disease, symptom, or sign that constitutes one of the target outcomes of the trial. The results of a clinical trial generally indicate the number of people enrolled who reached the pre-determined clinical endpoint during the of response rate for our Phase II 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. trial with 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 rapidly enrolled 50 patients for this trial and we plan to announce preliminary data in the second quarter of this year," said Evan M. Levine, ADVENTRX president and chief executive officer. "Additionally, we were granted orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the status for CoFactor, our biomodulator developed to enhance the activity of the widely used cancer drug 5-fluorouracil, or 5-FU, in both the US and 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 (EU) for pancreatic cancer 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. . "Further, we secured additional capital and strengthened our senior management to support our drug development programs," Mr. Levine continued. "Our plan is to commit the majority of our resources to the development of CoFactor, where we see the most significant near-term opportunity for market approval. This year we have already filed for clearance to initiate a 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 in the US and a Phase IIb trial in the EU with CoFactor in metastatic colorectal cancer and we intend to file in the first half of this year for clearance to initiate an EU-based Phase III study in pancreatic cancer." Fourth Quarter and Full Year Financial Review Research and development (R&D) expenses for the fourth quarter of 2004 were $691,000, compared with $334,000 for the same period in 2003. The increase in R&D expenses for the 2004 fourth quarter was due primarily to initiation of a clinical trial and continued preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. development of portfolio drugs. General and administrative expenses for the fourth quarter were $1.7 million, compared with $482,000 for the same period in 2003. The increase for the 2004 fourth quarter was due primarily to higher costs for facilities, addition of personnel, and increased legal fees primarily for corporate, human resources The fancy word for "people." The human resources department within an organization, years ago known as the "personnel department," manages the administrative aspects of the employees. and intellectual property activity. For the full year of 2004 R&D expenses were $2.7 million, compared with $749,000 for full year of 2003. The increase in 2004 R&D expenses was due mainly to initiation of a clinical trial and continued preclinical development of portfolio drugs. General and administrative expenses increased to $4.0 million in 2004, from $1.6 million in 2003, primarily due to expansion of facilities, addition of personnel, and increased legal fees for corporate and intellectual property activity. ADVENTRX reported cash and cash equivalents of approximately $13.0 million at December 31, 2004, compared with $4.2 million as of December 31, 2003. The cash increase reflects the completion of a private placement announced on April 5, 2004, resulting in gross proceeds of approximately $15.6 million. Annual Meeting of Stockholders ADVENTRX will hold its 2004 Annual Meeting of Stockholders on May 24, 2005 at 10:00 a.m. Pacific Daylight Time at the Company's headquarters, located at 6725 Mesa Ridge Road The name Ridge Road can refer to multiple streets and roads. Canada
Documents regulated by the Securities & Exchange Commission in which a public company outlines its methods and procedures. These documents are used to inform shareholders and solicit votes for corporate decisions, such as the election of directors and other along with pertinent information will be mailed to stockholders of record prior to the date of the meeting. About CoFactor CoFactor 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. CoFactor blocks cancer cell growth by creating more stable binding, compared to leucovorin, of 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. to allow 5-FU to work more effectively. This improves 5-FU performance and lowers toxicity. ADVENTRX is the exclusive licensee of this compound. 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 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. , 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. More information can be found on the Company's Web site at www.adventrx.com. Forward Looking Statement This press release contains forward-looking statements 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. 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 quarterly report on Form 10-QSB, 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 Statements of Operations
Three months ended Year ended
December 31, December 31,
--------------------- -----------------------
2004 2003 2004 2003
----------- --------- ----------- -----------
Net sales $ -- $ -- $ -- $ --
Cost of goods sold -- -- -- --
----------- --------- ----------- -----------
Gross margin -- -- -- --
Grant revenue -- -- -- 3,603
Interest income 58,300 4,805 103,042 9,269
----------- --------- ----------- -----------
58,300 4,805 103,042 12,872
----------- --------- ----------- -----------
Operating expenses:
Research and development 691,197 333,696 2,744,328 748,997
General and
administrative 1,702,517 482,420 4,018,453 1,585,596
Depreciation and
amortization 22,110 3,824 41,309 8,970
Interest expense -- -- -- 1,386
----------- --------- ----------- -----------
Total operating
expenses 2,415,824 819,940 6,804,090 2,344,949
----------- --------- ----------- -----------
Net loss (2,357,524) (815,135) (6,701,048) (2,332,077)
Preferred stock
dividends -- (9,460) -- (37,840)
----------- --------- ----------- -----------
Net loss
applicable to
common stock $(2,357,524)$(824,595)$(6,701,048)$(2,369,917)
=========== ========= =========== ===========
Loss per common
share - basic
and diluted $ (.04)$ (.02)$ (.13)$ (.07)
=========== ========= =========== ===========
ADVENTRX PHARMACEUTICALS, INC.
(Formerly Biokeys Pharmaceuticals, Inc.)
(A Development Stage Enterprise)
Condensed Consolidated Balance Sheets
December 31,
2004 2003
------------ ------------
Assets
Current assets:
Cash and cash equivalents $ 13,032,263 $ 4,226,397
Accrued interest income 10,808 --
Prepaid expenses 115,144 28,376
Assets available for sale 108,000 --
------------ ------------
Total current assets 13,266,215 4,254,773
------------ ------------
Property and equipment, net 285,304 20,840
Other assets 57,268 7,743
------------ ------------
Total assets $ 13,608,787 $ 4,283,356
============ ============
Liabilities and Shareholders' Equity (Deficit)
Current liabilities:
Accounts payable and accrued liabilities $ 1,161,081 $ 90,243
Accrued salary and related taxes 57,315 --
Accrued dividends payable -- 72,800
------------ ------------
Total liabilities 1,218,396 163,043
------------ ------------
Commitments and contingencies -- --
Shareholders' equity / (deficit):
Series A cumulative convertible Preferred
Stock, $0.01 par value; Authorized 8,000 shares;
issued and outstanding, 473 shares in 2003
(aggregate involuntary liquidation preference
$473,000 at December 31, 2003) -- 4
Series B convertible Preferred Stock, $0.01
par value; Authorized 200,000 shares in 2003;
issued and outstanding, 200,000 shares
(no liquidation preference) -- 2,000
Common stock, $0.001 par value. Authorized
100,000,000 shares; issued 53,834,237
in 2004 and issued and outstanding
42,491,708 shares in 2003 53,835 42,492
Additional paid-in capital 47,553,497 32,556,963
Deficit accumulated during
the development stage (35,182,194) (28,481,146)
Treasury stock, at cost (34,747) --
------------ ------------
Total shareholders' equity /
(deficit) 12,390,391 4,120,313
------------ ------------
Total liabilities and
shareholders' equity /
(deficit) $ 13,608,787 $ 4,283,356
============ ============
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