NEW YORK, Nov. 22, 2010 (GLOBE NEWSWIRE) -- Intellect Neurosciences, Inc. (OTCBB:ILNS), a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment and prevention of Alzheimer's disease with an internal diversified pipeline and licenses with major pharmaceutical companies covering products in late-stage clinical trials, today issued the following Letter to Shareholders from Dr. Daniel Chain, Chairman and CEO.
Dear Shareholder,
I would like to take this opportunity to update you regarding pertinent corporate and industry developments contemporaneous with the current filing of our quarterly financial statements with the SEC.
Of particular note were the promising statements made during an interview on October 18, 2010 by Sheri McCoy, Worldwide Chairman, Pharmaceuticals Group at Johnson & Johnson (J&J) regarding completion of enrollment in Phase 3 clinical trials and the expected filing date for Bapineuzumab, a monoclonal antibody that is based on Intellect's ANTISENILIN® platform technology. According to the transcript of the interview, (http://seekingalpha.com/article/230937-johnson-amp-johnson-management-discusses-q3-2010-results-earnings-call-transcript?source=feed), McCoy stated: "[Bapineuzumab] … probably has the greatest potential for disease modification. It would be first in class. This is an area that we have a tremendous opportunity to make a difference for patients. If you look at the cost associated with Alzheimer's disease, it is estimated in the U.S. to be about $150 billion. We have four trials underway in partnership with Pfizer. We are running the U.S. trials. We essentially have completed the enrollment in the main study and we're continuing to enroll in the biomarker sub-studies. And we anticipate filing in 2012/2013."
I am encouraged by these positive updates in relation to Bapineuzumab's development and its potential to meet the ever-growing need for a transformational treatment for Alzheimer's disease. It has been a long haul to see drug products based on my invention of more than a dozen years ago inch their way through years of challenging clinical trials while this devastating, neurodegenerative, fatal condition threatens to take an overwhelming toll. McCoy's public comments are the first to our knowledge regarding the anticipated filing date for Bapineuzumab, which was previously granted Fast Track designation by the Food and Drug Administration. Meanwhile, we continue our important mission to generate additional innovative drug products targeting key steps in the pathogenesis of Alzheimer's disease to tackle this complex disease through a multi-targeted approach."
Financial results:
We recognized a "Net Loss from Operations" of $1,688,280 for the three months ended September 30, 2010. More than $1 million of this Net Loss is a non-cash expense resulting from the issuance of common stock and warrants in exchange for services rendered. We recognized non-cash "Other Income" of $16,755,297, which results from changes in the fair value of derivative instruments that we have issued and a decrease in interest expense related to the Convertible Promissory Notes and Series B Preferred Stock that we converted into common stock in April 2010. As of September 30, 2010, we had cash on hand of approximately $85,000.
The capital markets continue to be challenging for "small-cap" biotech companies. In order to sustain operations, we obtained additional financing from certain of our current investors. On November 3, 2010, we borrowed a total of $150,000 from two of the purchasers of the notes that we issued in April 2010. Details of the incremental financing are described in our Form 10Q that we filed on November 18, 2010. We are in discussions with various potential investors regarding additional financing to sustain operations and fund our internal programs.
Increased public awareness:
We have continued our efforts to increase public and investor awareness of Intellect Neurosciences through media outreach and other activities.
Recent interviews included one with the New York Times and another with the popular health radio network show, "Ask Dr. DeSilva", in a special feature to mark Alzheimer's Awareness Month: http://www.healthradio.net/show/ask-dr-desilva/Health-Radio-Shows/Ask-Dr-2E-DeSilva/Alzheimer%E2%80%99s-Disease-Is-A-Global-Health-Crisis-43383/details. I have been invited to participate as a Distinguished Speaker at the upcoming 4th Annual Alzheimer's Drug Development Summit sponsored by The Center for Business Intelligence (CBI) December 14-15, 2010 in Washington D.C. www.cbinet.com/alzheimers). My speech on "Unique Molecular Signatures of Beta Amyloid as Targets for Therapy" is followed by a presentation from Pfizer discussing the Phase 2 clinical development of Ponezumab (PF-04360365), a highly specific monoclonal antibody against amyloid beta that is based on Intellect's ANTISENILIN® platform, as is Bapineuzumab.
Conclusion:
During the period covered by our Form 10Q, we continued discussions regarding potential joint ventures and collaborations with various strategic partners, including with large pharmaceutical companies that have expressed interest in our Alzheimer's preclinical and clinical stage pipeline. We look forward to reporting more fully on these activities in the future.
We were gratified by the comments made by the Chairman of Intellect's Scientific Advisory Board, Professor Kelvin Davies, in connection with the recent statements from J&J. Professor Davies, the James E. Birren Chair and Professor of Gerontology and Associate Dean at the Davis School of Gerontology, and Professor of Molecular and Computational Biology in the Department of Biological Sciences, at the University of Southern California commented: "Dr. Chain's numerous seminal contributions in the field of Alzheimer's therapeutics are evident in the activities of several major pharmaceutical companies that are developing drugs based on Dr. Chain's invention of the ANTISENILIN® platform, which uses highly specific antibodies to clear beta amyloid, the protein thought to play a critical role in the development of Alzheimer's disease. Dr. Chain continues to have remarkable scientific insights through which new drug applications are found and new products can be developed."
We thank you for your continued support of our mission and vision to create a world without Alzheimer's.
Sincerely,
Daniel Chain, PhD, Chairman and Chief Executive Officer
About Intellect Neurosciences, Inc.
Intellect Neurosciences Inc. is a Manhattan-based biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment and prevention of Alzheimer's disease and other disorders. The Company's drug product pipeline includes OX1, which has been tested in Phase 1 clinical trials; IN-N01, a humanized monoclonal antibody designed to promote the clearance of soluble amyloid beta; and RECALL-VAX, a vaccine technology that has the potential to delay or prevent Alzheimer's disease in people who are at risk.
The Company has significant intellectual property assets, which include several patent families underlying the Company's internal programs, and a pivotal patent estate regarding passive Alzheimer's immunotherapy.
The Company's ANTISENILIN(R) patent estate claims monoclonal antibodies that bind either end of amyloid beta but do not interact with the amyloid precursor protein from which amyloid beta is produced in the body. This high degree of specificity is an important safety feature, reducing the potential for adverse affects. Examples of monoclonal antibodies exhibiting this property are Bapineuzumab and Ponezumab, which are in Alzheimer's Phase 3 and Phase 2 clinical trials, respectively (http://clinicaltrials.gov/ct2/show/NCT00574132?term=bapineuzumab&rank=1; http://clinicaltrials.gov/ct2/results?term=PF-04360365).
Patents have been granted in Europe, Japan, China and elsewhere and are pending in the United States. Intellect has granted royalty-bearing licenses to its ANTISENILIN(R) patent estate to several top tier global pharmaceutical companies developing monoclonal antibodies for Alzheimer's disease. For further information, see the Company's filings with the Securities and Exchange Commission, including Forms 8-K filed on:
May 1, 2009
http://www.sec.gov/Archives/edgar/data/1337905/000114420409023426/v147731_8k.htm
January 8, 2009
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October 14, 2008
www.sec.gov/Archives/edgar/data/1337905/000114420408057464/0001144204-08-057464-index.htm" target="_top" rel="nofollow">http://www.sec.gov/Archives/edgar/data/1337905/000114420408057464/0001144204-08-057464-index.htm
May 19, 2008
www.sec.gov/Archives/edgar/data/1337905/000114420408030722/v115138_8k.htm" target="_top" rel="nofollow">http://www.sec.gov/Archives/edgar/data/1337905/000114420408030722/v115138_8k.htm
Safe Harbor Statement Regarding Forward-Looking Statements:
The statements in this release and oral statements made by representatives of Intellect relating to matters that are not historical facts (including without limitation those regarding future performance or financial results, the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Intellect's product candidates and the sufficiency of Intellect's cash and other capital resources) are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that actual performance or results could materially differ, that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, or Intellect's ability to fund such efforts with or without partners. Intellect undertakes no obligation to update any of these statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as to the date hereof. Accordingly any forward-looking statements should be read in conjunction with the additional risks and uncertainties detailed in Intellect's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in Intellect's Annual Report on Form 10-K, (file no. 333-128226) filed on October 13, 2010 and information contained in our Quarterly Report on Form 10-Q for the three month period ended on September 30, 2010 filed on November 18, 2010.