Axonyx Inc. Announces Third Quarter 2001 Financial Results.Business Editors NEW YORK--(BUSINESS WIRE)--Nov. 14, 2001 Axonyx Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : AXYX) today announced its results for the third quarter ended September 30, 2001. The Company reported a net loss of $2,325,000 or $0.15 per share for the third quarter of 2001 compared to $1,088,000 or $0.07 per share for the third quarter of 2000. Research and development costs for the third quarter were $1,693,000 compared to $668,000 for the third quarter of 2000. This increase was due primarily to costs related to the Phase II clinical trials 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 for Phenserine. General and administrative expenses for the third quarter were $694,000 compared to $585,000 for the third quarter of 2000. This increase is due primarily to an increase in investor relations Investor relations The process by which the corporation communicates with its investors. and professional fees offset in part by lower charges related to options granted to consultants. For the nine month period ended September 30, 2001, the Company reported a net loss of $6,705,000 or $0.44 per share, compared to a net loss of $3,996,000 or $0.27 per share for the comparable period in 2000. Research and development expenses for the nine month period ended September 30, 2001 were $4,542,000 compared to $2,151,000 for the same period last year. For the nine month period ended September 30, 2001, general and administrative costs administrative costs, n.pl the overhead expenses incurred in the operation of a dental benefits program, excluding costs of dental services provided. were $2,406,000 as compared to $2,254,000 for the nine month period ended September 30, 2000. On September 30, 2001, the Company had cash and cash equivalents of $4,381,000; there were 15,277,371 shares of the Company's common stock outstanding. "The positive Phase II trial results for our lead product Phenserine and the signing of an agreement with the U.S. Army Medical Research Institute of Chemical Defense for testing our compounds against Sarin sarin (zärēn`), volatile liquid used as a nerve gas. It boils at 147°C; but evaporates quickly at room temperature; its vapor is colorless and odorless. Gas, make the third quarter one of the most productive in Axonyx's history. We are confident that Phenserine can become a drug of choice in the worldwide multi-billion dollar Alzheimer's Disease Alzheimer's disease (ăls`hī'mərz, ôls–), degenerative disease of nerve cells in the cerebral cortex that leads to atrophy of the brain and senile dementia. market," said Marvin S. Hausman, M.D., President and Chief Executive Officer of Axonyx. "Towards that end, we are currently designing protocols for Phenserine's 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 trials," he added. Recent Achievements since the third quarter include: -- Completing the Phase II proof-of-concept study for Phenserine -- Releasing positive safety and efficacy results for Phase II study of Phenserine in patients with mild to moderate Alzheimer's Disease -- Signing an agreement to provide compounds to the US Army for testing against Sarin Gas and other chemical warfare agents Axonyx Inc. is a U.S.-based biopharmaceutical company engaged in the acquisition and development of proprietary pharmaceutical compounds and new technologies useful in the diagnosis and treatment of Alzheimer's Disease, human memory disorders There are several different types of memory disorders which occur in the human mind. Among these are less severe disorders including minor short term memory loss, and the eventually incapacitating Alzheimer's Disease. , and prion-based illnesses such as Mad Cow Disease mad cow disease: see prion. mad cow disease or bovine spongiform encephalopathy (BSE) Fatal neurodegenerative disease of cattle. Symptoms include behavioral changes (e.g. . This press release may contain 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. or predictions. These statements represent our judgment as of this date and are subject to risks and uncertainties that could materially affect the Company, including those risks and uncertainties described in the documents AXONYX files from time to time with the Securities and Exchange Commission, specifically AXONYX's Annual Report on Form 10-KSB, as amended a·mend v. a·mend·ed, a·mend·ing, a·mends v.tr. 1. To change for the better; improve: amended the earlier proposal so as to make it more comprehensive. 2. . Axonyx cannot assure that future clinical trials, if any, with Phenserine will prove successful, that the safety and efficacy profile of Phenserine exhibited in the small Phase II trial will remain the same in much larger Phase III trials, if any, that Axonyx will obtain the necessary financing to commence Phase III Phenserine trials, that the Company's development work on Phenserine will support an NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any filing, that 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. will grant marketing approval for Phenserine, that the FDA will approve the protocol for a Phase III trial, that the results of the Phase III trials will allow Phenserine to be approved by the FDA, that if Phenserine is approved by the FDA, it will prove competitive in the market, and that Axonyx will obtain licensing or corporate partnership agreements that will enable acceleration of the development of and optimize optimize - optimisation marketing opportunities for, Phenserine. Axonyx cannot assure that testing of its compounds by the U.S. Army Medical Research Institute of Chemical Defense will be successful and that any further relationship between the U.S. Army Medical Research Institute of Chemical Defense and Axonyx will develop, that AChE and BChE compounds will be found effective in testing against chemical warfare chemical warfare, employment in war of incendiaries, poison gases, and other chemical substances. Ancient armies attacking or defending fortified cities threw burning oil and fireballs. A primitive type of flamethrower was employed as early as the 5th cent. B.C. agents such as Sarin gas, that any of its compounds will have the ability to compete with lethal chemical agents, that its portfolio of compounds will successfully be tailored to meet the U.S. Army's requirements, or that the U.S. Army will be able to use any of Axonyx's compounds in models for possible protection against chemical warfare agents. Axonyx undertakes no obligation to publicly release the result of any revisions to such forward-looking statements that may be made to reflect events or circumstances CIRCUMSTANCES, evidence. The particulars which accompany a fact. 2. The facts proved are either possible or impossible, ordinary and probable, or extraordinary and improbable, recent or ancient; they may have happened near us, or afar off; they are public or after the date hereof here·of adv. Of this. hereof Adverb Formal or law of or concerning this Adv. 1. hereof - of or concerning this; "the twigs hereof are physic" or to reflect the occurrence of unanticipated events.
Axonyx Inc.
Summary of Consolidated Financial Statements for the Third Quarter
ended September 30, 2001
Consolidated Statements of Operations
(unaudited)
Three months ended Nine months ended
September 30, September 30,
2001 2000 2001 2000
Revenue $ - $ - $ - $ 104,000
Costs and expenses:
Research and
development 1,693,000 668,000 4,542,000 2,151,000
General and
administrative 694,000 585,000 2,406,000 2,254,000
------------ ------------ ------------ ------------
2,387,000 1,253,000 6,948,000 4,405,000
------------ ------------ ------------ ------------
Loss from
operations (2,387,000) (1,253,000) (6,948,000) (4,301,000)
Foreign exchange $ 9,000 $ (14,000) $ (26,000) $ (14,000)
Investment Income 53,000 179,000 269,000 319,000
------------ ------------ ----------- ------------
Net loss $(2,325,000) $(1,088,000) $(6,705,000) $(3,996,000)
============ ============ ============ ============
Net loss per
common share $ (0.15) $ (0.07) $ (0.44) $ (0.27)
============ ============ ============ ============
Weighted average
shares
basic and
diluted 15,277,371 15,269,544 15,277,371 14,582,548
Condensed Consolidated Balance Sheet
September 30, December 31,
2001 2000
------------------------------------
Cash and Cash Equivalents $4,381,000 $10,363,000
Total Assets $4,506,000 $10,457,000
Total Stockholders' equity $3,506,000 $ 9,683,000
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