IR BIOSCIENCES HOLDINGS INC Files SEC form 10-Q, Quarterly Report

ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION Special Note Regarding Forward-looking Statements Some of the statements under "Risk Factors" and elsewhere in this Quarterly Report on Form 10-Q constitute forward-looking statements. All statements other than historical facts contained in this report, including statements regarding our future financial position and revenues, capital expenditures, cash flows, business strategy and plans and objectives of management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by such forward-looking statements. Such factors include, among other things, those described under "Risk Factors" and elsewhere in this Quarterly Report on Form 10-Q and in the "Risk Factors" section of our annual report on SEC Form 10-K filed with the Securities and Exchange Commission on March 31, 2009 and as amended on April 30, 2009. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "could," "expects," "plans," "intends," "anticipates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of such terms or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of such statements. We are under no duty to update any of the forward-looking statements after the d...
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ImmuneRegen BioSciences(R) Reports Positive Results of Homspera(R) in Treating Highly Pathogenic Influenza

SCOTTSDALE, AZ--(Marketwire - 11/10/09) - ImmuneRegen BioSciences Inc.�, a wholly owned subsidiary of IR Biosciences Holdings Inc. (OTC.BB:IRBS - News), today announced positive results from a study that evaluated its lead anti-Influenza drug, Homspera. The study in animals infected with H5N1 (or "Avian") Influenza virus, which is highly lethal to humans and animals, revealed that Homspera treatment starting 1 day following Influenza infection dramatically reduced symptoms of Influenza infection and increased survival by 60% over infected controls. Performed at a public University under the guidance of a world-renowned Influenza expert, the study utilized a 'real-world' scenario of highly pathogenic Influenza infection by a clade 2.2 H5N1 virus (A/Whooperswan/Mongolia/244/2005); Homspera treatment commenced 1 day following Influenza infection, which coincided with the first signs of disease symptoms. The study also utilized the most widely accepted model of Influenza infection, the fer...
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ImmuneRegen BioSciences(R) to Further Homspera(R) Research in Study Funded by U.S. Government

SCOTTSDALE, AZ--(Marketwire - 10/22/09) - ImmuneRegen BioSciences Inc.�, a wholly owned subsidiary of IR Biosciences Holdings Inc. (OTC.BB:IRBS - News), today announced the commencement of a study, in collaboration with Dr. Jacob Finkelstein at the University of Rochester Medical School, funded by the U.S. government. Dr. Finkelstein's research group at the University of Rochester's Center for Biophysical Assessment and Risk Management Following Irradiation (CBARMFI) will evaluate the efficacy of Homspera� in reducing the detrimental effects of radiation on lung immune system function. ...
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ImmuneRegen BioSciences(R) Initiates Homspera(R) Studies Against Global Influenza Threat

SCOTTSDALE, AZ--(Marketwire - 10/12/09) - ImmuneRegen BioSciences, Inc.�, a wholly owned subsidiary of IR Biosciences Holdings, Inc. (OTC.BB:IRBS - News), today announced that its lead anti-influenza drug, Homspera, will be tested for efficacy against highly lethal H5N1 Avian Influenza in the laboratories of a widely respected University scientist. Additionally, testing at an independent facility will further define the adjuvant efficacy of Homspera when coupled with a novel vaccine for H5N1 in studies sponsored by an ImmuneRegen industry partner. The influenza A virus is one of the most highly evolving and dangerous viruses that infect humans. Seasonal influenza is highly contagious and even with a relatively low lethality of approximately 0.12% (mostly the very young, elderly or chronically ill individuals), it kills about 36,000 Americans annually. The newly recognized ...
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ImmuneRegen BioSciences(R) Announces Strategic Partnership With Azopharma Product Development Group, Inc.

SCOTTSDALE, AZ--(Marketwire - 09/23/09) - ImmuneRegen BioSciences, Inc.�, a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTC.BB:IRBS - News), today announced the execution of a Letter of Intent to enter a Strategic Partnership Agreement with Azopharma Product Development Group, Inc. Under the agreement, Azopharma will perform research services to further develop ImmuneRegen's lead drug candidate Homspera�. Under the terms of this non-binding Letter of Intent, Azopharma will provide full development services to ImmuneRegen, which include drug manufacturing, formulation development, and pre-clinical services including IND-enabling toxicology and safety pharmacology studies. Azopharma is a leading Contract Research Organization based in North America which is unique in being able to provide total product development services for the pharmaceutical, biotechnology, and medical device industries. Additionally, Azopharma scientists have experience in the development of inhaled drugs and medical devices, which is of particular importance to ImmuneRegen.Phil Meeks, CEO of Azopharma Product Development G...
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ImmuneRegen BioSciences(R) Announces Partnership With Bachem, Inc., for Manufacturing of Homspera(R)

SCOTTSDALE, AZ--(Marketwire - 09/22/09) - ImmuneRegen BioSciences�, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTC.BB:IRBS - News), today announced an agreement with Bachem, Inc., enabling Bachem to be the primary manufacturer of ImmuneRegen's Homspera� drug substance. Homspera is a peptide analog of the endogenous neurokinin Substance P, and is actively being developed by ImmuneRegen for a number of therapeutic indications including cancer, infectious diseases, pulmonary diseases such as Idiopathic Pulmonary Fibrosis, and wound healing. Under the agreement Bachem will produce the active pharmaceutical ingredient Homspera under current Good Manufacturing Practices (cGMP) in quantities necessary to support formulation, pre-clinical studies and to perform a number of Phase I studies in humans under an FDA-cleared Investigation New Drug Application (IND). Only drugs produced under cGMP may be administered to humans."The opportunit...
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IR BioScience Holdings Inc. CFO Interview: John N. Fermanis

67 WALL STREET, New York - September 15, 2009 - The Wall Street Transcript has just published its Medical Research Services report offering a timely review of the sector to serious investors and industry executives. This 23 page feature contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online. Topics covered: Medical Device Research Services - Pharmaceutical Research Services - Diagnostics - Life Science Research Supplies - Biology R & D - Lab Services Business Model - International Economic Exposure - Effect of Recession on Sector Stocks - Top Stock Winners and Losers in Medical Research Services - Top Stock Winners and Losers in Medical Diagnostics Companies include: Arrowhead Research (ARWR); Cleveland BioLabs (CBLI); IR BioSciences Holdings (IRBS); Power3 Medical Products (PWRM); Illumina (ILMN); Luminex (LMNX); Waters (WAT); Life Technologies (LIFE); QIAGEN (QGEN); Sangamo BioSciences (SGMO); Beckman Coulter (BEC); Invitrogen (IVGN); Amgen (AMGN); Bristol-Myers (BMY); Eli Lilly & Co. (LLY); Myriad Genetics (MYGN); Genomic Health (GHDX); Targeted Genetics (TGEN); Dow Chemical (DOW); Sigma-Aldrich (SIAL); MDS (MDZ); Danaher (DHR); Cepheid (CPHD); Inverness Medical Innovations (IMA); Quidel (QDEL); Meridian Bioscience (VIVO); Gen-Probe (GPRO); Sequenom (SQNM); Genoptix (GXDX); Response Genetics (RGDX); Affymetrix (AFFX); Monogram Bioscience (MGRN); LabCorp (LH) In the following brief excerpt from the 23 page report, John N. F...
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IR BIOSCIENCES HOLDINGS INC Financials

PERIOD ENDING30-Jun-0931-Mar-0931-Dec-0830-Sep-08Total Revenue -   -   -   -  Cost of Revenue -   -   -   -  Gross Profit -   -   -   -  Operating ExpensesResearch Development -   -   -   -  Selling General and Administrative820  845  1,205  1,808  Non Recurring -   -   -   -  Others -   -   -   -  Total Operating Expenses -   -   -   -  Operating Income or Loss(820)(845)(1,205)(1,808)Income from Continuing OperationsTotal Other Income/Expenses Net(676)(764)(179) -  Earnings Before Interest And Taxes(1,495)(1,608)(1,384)(1,808)Interest Expense533  533  294  206  Income Before Tax(2,029)(2,141)(1,678)(2,014)Income Tax Expense -   -   -   -  Minority Interest -   -   -   -  Net Income From Continuing Ops(2,029)(2,141)(1,678)(2,014)Non-recurring EventsDiscontinued Operations -   -   -   -  Extraordinary Items -   -   -   -  Effect Of Accounting Changes - ...
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ImmuneRegen BioSciences(R) Partners With University of Rochester in BARDA Funding Bid

SCOTTSDALE, AZ--(Marketwire - 09/09/09) - ImmuneRegen BioSciences�, a wholly owned subsidiary of IR Biosciences Holdings Inc. (OTC.BB:IRBS - News), today announced that, in collaboration with Dr. Jacob Finkelstein at the University of Rochester School of Medicine, they have submitted a proposal to the U.S. government seeking funding to develop Homspera� as a post-exposure therapy for injury resulting from ionizing radiation exposure. The proposal [a Broad Agency Announcement (BAA), sponsored by The Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services] expands on research ImmuneRegen has previously performed demonstrating efficacy of Homspera in treating pulmonary injury as well as mitigating acute effects, including the hematopoietic syndrome, resulting from exposure to ionizing radiation. The proposal utilizes animal models validated at the Unive...
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