Neurologix Announces Third Quarter Results.Landmark Clinical Trial for Parkinson's Disease Parkinson's disease or Parkinsonism, degenerative brain disorder first described by the English surgeon James Parkinson in 1817. When there is no known cause, the disease usually appears after age 40 and is referred to as Parkinson's disease. Completed in October FORT LEE, N.J. -- Neurologix, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : NRGX), a biotech bi·o·tech n. Informal Biotechnology. biotech Noun short for biotechnology Noun 1. company engaged in the development of innovative gene therapies for the brain and central nervous system, announced today its financial results for the quarter and nine months ended September 30, 2006. Having recently announced statistically significant clinical efficacy results of the first ever human gene therapy clinical trial for Parkinson's disease in October 2006 at the Annual Meeting of the Society of Neuroscience neu·ro·sci·ence n. Any of the sciences, such as neuroanatomy and neurobiology, that deal with the nervous system. neuroscience the embryology, anatomy, physiology, biochemistry and pharmacology of the nervous system. in Atlanta, Neurologix is planning to move into the next stages of clinical development of its NLX (hardware, standard) NLX - A low-profile, low TCO motherboard design created jointly by Intel Corp., IBM, DEC and other PC vendors. In contrast to the traditional single-board design, NLX uses a riser card to carry PCI, ISA and AGP bus data (despite Intel's stated intent to rid PC gene therapy technology, including further studies for Parkinson's disease and a Phase I human trial for temporal lobe epilepsy temporal lobe epilepsy n. See psychomotor epilepsy. . For the quarter ended September 30, 2006, the Company reported a net loss of $2.5 million, as compared with $1.0 million for the quarter ended September 30, 2005. The Company reported a net loss applicable to common stock for the quarter ended September 30, 2006, of $2.8 million, or $0.10 per diluted share, as compared with $1.0 million, or $0.04 per share, for the same period in 2005. The net loss applicable to common stock for the quarter ended September 30, 2006 includes charges of $277,000 related to preferred stock Stock shares that have preferential rights to dividends or to amounts distributable on liquidation, or to both, ahead of common shareholders. Preferred stock is given preference over common stock. Holders of preferred stock receive dividends at a fixed annual rate. dividends in connection with the issuance of the Company's Series C Preferred Stock. The Company has cash, cash equivalents and short-term investments of approximately $11.7 million at September 30, 2006. For the nine months ended September 30, 2006, the Company reported a net loss of $5.6 million, as compared with $3.5 million for the nine months ended September 30, 2005. The Company reported a net loss applicable to common stock for the nine months ended September 30, 2006, of $8.7 million, or $0.33 per diluted share, as compared with $3.5 million, or $0.14 per diluted share, for the same period in 2005. The net loss applicable to common stock for the nine months ended September 30, 2006, includes charges of $3.0 million, or $0.11 per diluted share, related to accretion of a beneficial conversion feature ($2.6 million) and preferred stock dividends ($0.4 million) in connection with the issuance of the Company's Series C Preferred Stock in May 2006. In commenting on the Company's performance, John E. Mordock, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , said, "The landmark results of our Phase I Parkinson's disease clinical trial confirmed the safety and tolerability tol·er·a·ble adj. 1. Capable of being tolerated; endurable. 2. Fairly good; passable. See Synonyms at average. tol of our Parkinson's gene therapy treatment and also yielded statistically significant clinical efficacy results. We are encouraged by these results because the treatment was confined con·fine v. con·fined, con·fin·ing, con·fines v.tr. 1. To keep within bounds; restrict: Please confine your remarks to the issues at hand. See Synonyms at limit. to a single side of the brain. Future studies are planned for the bilateral installation of the therapy and measuring treatment effects on both sides of the brain, which we hope will produce stronger efficacy results. We look forward to validating our results in future trials and continuing our efforts to develop a major new treatment for Parkinson's disease worldwide." The Company currently plans to conduct one or more interim trials prior to conducting a pivotal trial for its treatment of Parkinson's disease. The Company hopes to begin the interim trials in the second quarter of 2007. The scope and timing of such trials will largely depend upon 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. concurrence CONCURRENCE, French law. The equality of rights, or privilege which several persons-have over the same thing; as, for example, the right which two judgment creditors, Whose judgments were rendered at the same time, have to be paid out of the proceeds of real estate bound by them. Dict. de Jur. h.t. , the ability to manufacture product on a timely basis, the availability of funding and other factors. These trials will be designed, among other things, to test the therapy bilaterally, determine the proper dosing and test the catheter catheter /cath·e·ter/ (kath´e-ter) 1. a tubular, flexible surgical instrument that is inserted into a cavity of the body to withdraw or introduce fluid. 2. urethral c. system developed by Medtronic pursuant to its development agreement with the Company. About Neurologix Neurologix, Inc. is a development-stage company engaged in the research and development of proprietary treatments for disorders of the brain and central nervous system utilizing gene therapies. The Company's initial development efforts are focused on gene therapy for treating Parkinson's disease, epilepsy epilepsy, a chronic disorder of cerebral function characterized by periodic convulsive seizures. There are many conditions that have epileptic seizures. Sudden discharge of excess electrical activity, which can be either generalized (involving many areas of cells in and Huntington's disease Huntington's disease, hereditary, acute disturbance of the central nervous system usually beginning in middle age and characterized by involuntary muscular movements and progressive intellectual deterioration; formerly called Huntington's chorea. . Neurologix's core technology, "NLX," is currently being tested in a Company-sponsored Phase I human clinical trial to treat Parkinson's disease. Cautionary Statement Regarding 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. This news release includes certain statements of the Company that may constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are made pursuant to 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. These forward-looking statements and other information relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the Company are based upon the beliefs of management and assumptions made by and information currently available to the Company. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events, or performance, as well as underlying assumptions and statements that are other than statements of historical fact. When used in this document, the words "expects," "promises," "anticipates," "estimates," "plans," "intends," "projects," "predicts," "believes," "may" or "should," and similar expressions, are intended to identify forward-looking statements. These statements reflect the current view of the Company's management with respect to future events. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, but not limited to, the following: * The Company is still in the development stage and has not generated any revenues. From inception through September 30, 2006, it incurred net losses and negative cash flows from operating activities of approximately $19.8 million and $15.1 million, respectively. Management believes that the Company will continue to incur net losses and cash flow deficiencies from operating activities for the foreseeable future. Because it may take years to develop, test and obtain regulatory approval for a gene-based therapy product before it can be sold, the Company likely will continue to incur significant losses for the foreseeable future. Accordingly, it may never be profitable and, if it does become profitable, it may be unable to sustain profitability. * In order to obtain the regulatory approvals necessary to commercialize its current or future product candidates, from time to time the Company will need to raise funds through public or private equity offerings, debt financings Debt Financing When a firm raises money for working capital or capital expenditures by selling bonds, bills, or notes to individual and/or institutional investors. In return for lending the money, the individuals or institutions become creditors and receive a promise to repay or additional corporate collaboration and licensing arrangements. Availability of financing depends upon a number of factors beyond the Company's control, including market conditions and interest rates. The Company does not know whether additional financing will be available when needed, or if available, will be on acceptable or favorable terms to it or its stockholders. * The Company will need to conduct future clinical trials for treatment of Parkinson's disease using the Company's NLX technology. If the trials prove unsuccessful, future operations and the potential for profitability will be materially adversely affected and the business may not succeed. * There is no assurance as to when, or if, the Company will be able to successfully complete the required preclinical testing Noun 1. preclinical test - a laboratory test of a new drug or a new invasive medical device on animal subjects; conducted to gather evidence justifying a clinical trial preclinical phase, preclinical trial of its gene therapy for the treatment of epilepsy to enable it to file an Investigational New Drug Application with the FDA for permission to begin a Phase I safety trial or that, if filed, such permission will be granted. Other factors and assumptions not identified above could also cause the actual results to differ materially from those set forth in the forward-looking statements. Additional information regarding factors that could cause results to differ materially from management's expectations is found in the section entitled "Risk Factors" in the Company's 2005 Annual Report on Form 10-KSB. Although the Company believes these assumptions are reasonable, no assurance can be given that they will prove correct. Accordingly, you should not rely upon forward-looking statements as a prediction of actual results. Further, the Company undertakes no obligation to update forward-looking statements after the date they are made or to conform the statements to actual results or changes in the Company's expectations. [TABLE OMITTED] [TABLE OMITTED] |
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