FORM 10-QSB/A
                                 AMENDMENT NO. 2


                       SECURITIES AND EXCHANGE COMMISSION
                             WASHINGTON, D. C. 20549

(X) Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange
                                  Act of 1934

               For the quarterly period ended September 30, 2004

                                      or

( ) Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange
                                   Act of 1934

           For the transition period from ___________ to _____________

                        COMMISSION FILE NUMBER: 033-05384

                          IR BIOSCIENCES HOLDINGS, INC.
             (Exact name of Registrant as specified in its charter)

             Delaware                                       13-3301899
   -------------------------------                      -------------------
   (State or other jurisdiction of                       (I.R.S. Employer
    incorporation or organization)                      Identification No.)

           4021 N. 75th Street , Suite 201, Scottsdale, Arizona 85251
                (Address of principal executive offices) Zip Code

       Registrant's telephone number, including area code: (480) 922-3926

   (Former name, former address and former fiscal year, if changed since last
                                     report)

Indicate by check mark whether  Registrant (1) has filed all reports required to
be filed by Section 13 or 15(d) of the  Securities  Exchange  Act of 1934 during
the preceding  twelve months or for such shorter  period that the Registrant was
required  to file  such  reports,  and  (2)  has  been  subject  to such  filing
requirements for the past 90 days. Yes X    No

The number of shares outstanding of Registrant's common stock as of November 10,
2004 was 61,839,163.

<PAGE>

                       IR BIOSCIENCES, INC. AND SUBSIDIARY

                                TABLE OF CONTENTS


                                                                     Page Number
                                                                     -----------
PART I.   FINANCIAL INFORMATION

  Item 2. Management's Discussion and Analysis of Financial Condition
          or Plan of Operation.................................................3

PART II.  OTHER INFORMATION

  Item 6. Exhibits and Reports on Form 8-K....................................15

          Signatures..........................................................16


                                        2

<PAGE>


                         PART I - FINANCIAL INFORMATION


<PAGE>

ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATIONS.

                Special Note Regarding Forward-looking Statements
                -------------------------------------------------

The  following  information  should be read in  conjunction  with the  financial
statements  and the notes  thereto.  The  analysis  set forth  below is provided
pursuant to applicable Securities and Exchange Commission regulations and is not
intended to serve as a basis for projections of future events.

EXCEPT FOR HISTORICAL  INFORMATION  CONTAINED  HEREIN,  THE MATTERS DISCUSSED IN
THIS  QUARTERLY  REPORT  FORM  10-QSB ARE  FORWARD-LOOKING  STATEMENTS  THAT ARE
SUBJECT TO CERTAIN RISKS AND  UNCERTAINTIES  THAT COULD CAUSE ACTUAL  RESULTS TO
DIFFER MATERIALLY FROM THOSE SET FORTH IN SUCH FORWARD-LOOKING  STATEMENTS. SUCH
FORWARD-LOOKING   STATEMENTS   MAY  BE   IDENTIFIED   BY  THE  USE  OF   CERTAIN
FORWARD-LOOKING  TERMINOLOGY,  SUCH AS "MAY," "EXPECT,"  "ANTICIPATE," "INTEND,"
"ESTIMATE,"   "BELIEVE,"  OR  COMPARABLE  TERMINOLOGY  THAT  INVOLVES  RISKS  OR
UNCERTAINTIES.  ACTUAL  FUTURE  RESULTS  AND TRENDS MAY DIFFER  MATERIALLY  FROM
HISTORICAL AND ANTICIPATED RESULTS,  WHICH MAY OCCUR AS A RESULT OF A VARIETY OF
FACTORS.  SUCH RISKS AND  UNCERTAINTIES  INCLUDE,  WITHOUT  LIMITATION,  FACTORS
DESCRIBED  UNDER "RISK FACTORS" AND ELSEWHERE IN THIS  QUARTERLY  REPORT ON FORM
10-Q.  EXCEPT FOR OUR ONGOING  OBLIGATION TO DISCLOSE  MATERIAL  INFORMATION  AS
REQUIRED BY FEDERAL  SECURITIES  LAWS, WE DO NOT INTEND TO UPDATE YOU CONCERNING
ANY FUTURE  REVISIONS TO ANY  FORWARD-LOOKING  STATEMENTS  TO REFLECT  EVENTS OR
CIRCUMSTANCES OCCURRING AFTER THE DATE OF THIS REPORT

The  following  information  should be read in  conjunction  with the  financial
statements  and the notes  thereto.  The  analysis  set forth  below is provided
pursuant to applicable Securities and Exchange Commission regulations and is not
intended to serve as a basis for projections of future events.

Overview
--------

Our company, IR BioSciences Holdings, Inc., is a Delaware corporation and, until
July 2001, was engaged in the business, through its subsidiaries, affiliates and
strategic alliances, of assisting unaffiliated early-stage development and small
to mid-sized  emerging growth companies with financial and business  development
services,  including  raising  capital in private and public  offerings.  During
2001, due in large part to the decreased  availability of investment  capital to
our then target market of Internet related, small growth companies, we failed to
meet our revenue targets.  On July 27, 2001, a majority  interest in our company
was acquired by a private investor,  and we installed new management and adopted
a new business plan. The immediate action taken regarding this new business plan
was to discontinue our then current operations effective July 27, 2001.

On July 2, 2003, our company and ImmuneRegen Biosciences, Inc., a privately-held
Delaware corporation ("ImmuneRegen"),  entered into and consummated an Agreement
and Plan of Merger (the  "Merger").  In accordance  with the Merger,  on July 2,
2003, we acquired  ImmuneRegen in exchange for  10,531,585  shares of our common
stock.  The  transaction  contemplated  by the  Agreement  was  intended to be a
"tax-free"  reorganization  pursuant  to  the  provisions  of  Section  351  and
368(a)(1)(A)  of the Internal  Revenue Code of 1986,  as amended.  On August 29,
2003, the Registrant's name was changed from GPN Network, Inc. to IR BioSciences
Holdings, Inc.

ImmuneRegen is a  biotechnology  company engaged in the research and development
of  applications   utilizing  modified   Substance  P,  a  naturally   occurring
immunomodulator. Derived from homeostatic Substance P, ImmuneRegen has named its
proprietary  compound "Homspera."  Currently,  ImmuneRegen holds two patents and
four provisional patents in the United States. Additionally, ImmuneRegen holds a
patent  with the  European  Union and  Australia  and is  seeking  to extend its
patents into Canada and, possibly, Japan.

Our  initial  areas  of  focus  will be in  continuing  development  of  several
applications for use in improving  pulmonary function and stimulating the immune
system.  These applications have been derived from research studies and positive
results from laboratory tests conducted by management over the past nine years.

With  the  assistance  of  our  U.S.  Food  and  Drug   Administration   ("FDA")
consultants,  Synergos,  Inc.,  we plan to apply  for  Investigational  New Drug
("IND")  approval  from the FDA.  Based on our past test results and  continuing
studies,  we believe that the IND may be  activated,  allowing us to begin human
clinical  trials  using the  Homspera  compound as a  treatment  for lung injury
caused by acute respiratory disease syndrome ("ARDS").

                                        3

<PAGE>

Our goal is to enter into  overseas  licensing  and royalty  agreements  for its
applications  while  awaiting  approval  by the FDA in the Unites  States.  Once
approval  has been  obtained  by the FDA,  we hope to  further  expand our sales
efforts internationally and will attempt to begin to generate sales domestically
through the licensing and the direct sales of our products in the United States.
Our goal is to  strategically  align  ourselves with larger  pharmaceutical  and
other biotechnology and medical research companies, which we believe may enhance
our ability to succeed in reaching the  objectives of bringing its  applications
to the marketplace.  If FDA approval is granted,  we intend to seek to establish
license  agreements and  relationships  domestically that will bring Homspera to
those in need of it.

We have  established a pilot  manufacturing  facility at our lab headquarters in
Tucson,  Arizona for the production of immune-based  therapies.  We expect these
facilities to be adequate to supply limited  clinical  trial  quantities for our
products under development. Additional manufacturing capacity will be needed for
commercial  scale  production,  if these  therapies are approved for  commercial
sale.

For the manufacture of the applications under  development,  we obtain synthetic
peptides from third party manufacturers.  We believe that synthesized version of
Substance  P is readily  available  at low cost from  several  life  science and
technology  companies that provide biochemical and organic chemical products and
kits used in  scientific  and genomic  research,  biotechnology,  pharmaceutical
development and the diagnosis of disease and chemical manufacturing.  We believe
that the synthetic Substance P and other materials necessary to produce Homspera
are readily available from various sources, and several suppliers are capable of
supplying  Substance  P  in  both  clinical  and  commercial  quantities.  These
suppliers also store and ship the product as well.

We expect  that our  products  will use an  inhaler  (puffer)  device to deliver
Homspera to the user. To develop, manufacture and test an inhaler device we hope
to partner with a drug  development  and chemical  services  company that offers
services  ranging from  pre-clinical  and  toxicology  studies to clinical trial
support and  manufacturing  services.  We believe  that such a  partnership  may
enable us to decrease  the  time-to-market  for our products and to increase our
productivity.

RESULTS OF OPERATIONS - THREE MONTHS ENDED SEPTEMBER 30, 2004

Revenue
-------

We are in the development stage and have no revenue.

SALES, GENERAL, AND ADMINISTRATIVE EXPENSES

Sales,  general,  and  administrative  expenses ("SG&A") were $1,041,162 for the
three months ended September 30, 2004, an increase of $743,565 or  approximately
250%  compared to SG&A of $297,587  during the three months ended  September 30,
2003.  For the three months ended  September  30,  2004,  this amount  consisted
primarily of non-cash compensation issued to consultants of $746,259,  legal and
accounting fees of $63,366,  other consulting fees of $56,550,  officer wages of
$43,750,  contract labor of $24,244,  and research and  development  expenses of
$22,709.  The increase was due primarily to an increase in the value of non-cash
compensation, which was $0 during the three months ended September 30, 2004.

The Company  expects  SG&A to  increase  during the coming  twelve  months as we
continue to utilize  non-cash  compensation  in order to conserve cash, we build
out the Company's infrastructure,  and continue to develop the Company's line of
potential products.

Interest Expense
----------------

Interest  expense was $70,612 for the three months ended  September 30, 2004, an
decrease of $18,408 or approximately 21% compared to interest expense of $89,020
for the three months ended  September 30, 2003.  In the quarter ended  September
30,  2004,  interest  expense  consisted  of stock  issued for interest and loan
extension charges of $36,000,  interest accrued on notes payable of $22,930, and
amortization  of discount on notes payable of $11,682.  Interest  decreased from
the comparable  period of the prior year due to  amortization  of the beneficial
conversion features of notes payable during the three months ended September 30,
2003.

The Company expects interest expense to decrease during the coming twelve months
because  most of the  Company's  outstanding  debt was  converted  to  equity in
November 2004.

                                        4

<PAGE>

Net Loss
--------

For the reasons  above,  the net loss for the three months ended  September  30,
2004 was $1,111,764,  an increase of $285,157 or 34.5% compared to a net loss of
$826,607 for the three months ended September 30, 2003.

The Company  expects  losses to increase  during the coming twelve  months.  The
Company  does not  expect to begin to  generate  revenue  in the  coming  twelve
months,  and our costs are likely to increase  as we move our line of  potential
products  through  the  testing  and  approval  phases,  and as we build out our
corporate infrastructure.

RESULTS OF OPERATIONS - NINE MONTHS ENDED SEPTEMBER 30, 2004

Revenue
-------

We are in the development stage and have no revenue.

Selling, General and Administrative Expenses
--------------------------------------------

SG&A expenses were  $3,546,641 for the nine months ended  September 30, 2004, an
increase of  $2,879,980 or  approximately  432% compared to SG&A of $666,661 for
the nine months  ended  September  30, 2003.  For the 2004  period,  this amount
consists primarily of non-cash compensation of $2,600,818,  legal and accounting
fees of  $249,077,  officer  wages of  $131,350,  consulting  fees of  $121,550,
research and development  costs of $84,519,  and contract labor of $65,747.  The
increase was due primarily to an increase in the value of non-cash compensation,
which was $0 during the nine months ended September 30, 2004.

The Company  expects  SG&A to  increase  during the coming  twelve  months as we
continue to utilize  non-cash  compensation  in order to conserve cash, we build
out the Company's infrastructure,  and continue to develop the Company's line of
potential products.

Interest Expense
----------------

Interest  expense was $506,427 for the nine months ended  September 30, 2004, an
increase of  $394,765  or  approximately  354%  compared to interest  expense of
$111,662 for the nine months ended September 30, 2003. For the nine months ended
September 30, 2004, interest expense consists of amortization of the discount on
notes payable of $412,815,  and interest on notes payable of $57,612,  and stock
issued for interest and loan extension charges of $36,000.

The Company expects interest expense to decrease during the coming twelve months
because  most of the  Company's  outstanding  debt was  converted  to  equity in
November 2004.

Net Loss
--------

For the reasons above, the net loss for the nine months ended September 30, 2004
was $4,053,068, an increase of $2,834,745 or approximately 35% compared to a net
loss of $1,218,323 for the nine months ended September 30, 2003.

The Company  expects  losses to increase  during the coming twelve  months.  The
Company  does not  expect to begin to  generate  revenue  in the  coming  twelve
months,  and our costs are likely to increase  as we move our line of  potential
products  through  the  testing  and  approval  phases,  and as we build out our
corporate infrastructure.

LIQUIDITY AND CAPITAL RESOURCES

At  September  30,  2004,  we had current  assets of $2,300  consisting  prepaid
services of $2,300.  Also at September 30, 2004, we had current  liabilities  of
$1,949,349  consisting  of a cash  overdraft  of $5,153,  notes  payable  net of
discount of $1,044,365 and accounts payable and accrued liabilities of $899,831.
This results in negative working capital of ($1,947,049). During the nine months
ended  September  30, 2004,  the Company used cash in  operating  activities  of
($448,944). From the date of inception (October 30, 2002) to September 30, 2004,
the Company has had a net loss of ($5,955,688) and has used cash of ($1,482,107)
in operating activities.

                                        5

<PAGE>

The Company  currently has no revenue.  There is no guarantee  that our business
model will be successful, or that we will be able to generate sufficient revenue
to fund future operations.  As a result, we expect our operations to continue to
use net cash,  and that we will be  required to seek  additional  debt or equity
financings during the coming quarters. Since Inception, the Company has financed
its operations  through debt and equity financing.  While we have raised capital
to meet  our  working  capital  and  financing  needs  in the  past,  additional
financing  is  required in order to meet our  current  and  projected  cash flow
deficits from  operations and  development of our product line. In October 2004,
the Company  completed  the private  placement of its common stock for the gross
amount of  $2,465,000.  It is expected  that in order to implement  its business
plan, the Company will require  additional  capital.  There can be absolutely no
assurance that we will be able to consummate future debt or equity financings in
a timely manner on a basis favorable to us, or at all.

By adjusting its operations and  development  to the level of  capitalization  ,
management  believes it has sufficient  capital resources to meet projected cash
flow deficits through the next twelve months. However, if thereafter, we are not
successful  in generating  sufficient  liquidity  from  operations or in raising
sufficient  capital  resources,  on terms  acceptable  to us,  this could have a
material  adverse effect on our business,  results of operations , liquidity and
financial condition.

Product Research and Development
--------------------------------

We anticipate performing further research and development of the applications of
our  proprietary  compound  "Homspera"  during  the next  twelve  months.  These
projected  expenditures are dependent upon our generating revenues and obtaining
sources of financing in excess of our existing  capital  resources.  There is no
guarantee that we will be successful in raising the funds required or generating
revenues  sufficient  to fund the  projected  costs of research and  development
during the next twelve months

Acquisition of Plant and Equipment and Other Assets
---------------------------------------------------

We do not  anticipate  the sale of any  material  property , plant or  equipment
during the next 12 months.  We do not anticipate the acquisition of any material
property, plant or equipment during the next 12 months.

Number of Employees
-------------------

From our inception  through the period ended  September 30, 2004, we have relied
on the services of outside  consultants  for services and have one (1) employee.
Our sole full time employee is our Chief Executive Officer,  Michael K. Wilhelm.
In order for us to attract and retain quality  personnel,  we anticipate we will
have to offer competitive  salaries to future  employees.  We anticipate that it
may  become  desirable  to add  additional  full and or part time  employees  to
discharge certain critical  functions during the next 12 months.  This projected
increase in  personnel is  dependent  upon our ability to generate  revenues and
obtain sources of financing. There is no guarantee that we will be successful in
raising  the  funds  required  or  generating  revenues  sufficient  to fund the
projected increase in the number of employees. As we continue to expand, we will
incur additional cost for personnel.

Trends, Risks and Uncertainties
-------------------------------

We have sought to identify what we believe to be the most  significant  risks to
our business,  but we cannot  predict  whether,  or to what extent,  any of such
risks may be realized nor can we guarantee that we have  identified all possible
risks that might arise.  Investors  should  carefully  consider all of such risk
factors before making an investment decision with respect to our Common Stock.

RISK FACTORS

The actual  results of the  combined  company may differ  materially  from those
anticipated in these forward-looking  statements. The Registrant and ImmuneRegen
will operate as a combined company in a market  environment that is difficult to
predict and that involves  significant  risks and  uncertainties,  many of which
will  be  beyond  the  combined   company's   control.   Additional   risks  and
uncertainties  not presently  known,  or that are not  currently  believed to be
important to you, if they  materialize,  also may adversely  affect the combined
company.

                                        6

<PAGE>


WE HAVE  LIMITED CASH  RESOURCES,  AN  ACCUMULATED  DEFICIT,  ARE NOT  CURRENTLY
PROFITABLE AND EXPECTS TO INCUR SIGNIFICANT EXPENSES IN THE NEAR FUTURE.

As December 31, 2003, our working capital  totaled  approximately $ (1,947,049).
We have  incurred a  substantial  net loss for the period from our  inception in
October 2002 to September 30, 2004, and we are currently  experiencing  negative
cash flow.  ImmuneRegen expects to continue to experience negative cash flow and
operating  losses  through at least 2004 and possibly  thereafter.  As a result,
ImmuneRegen will need to generate significant revenues to achieve profitability.
If our  revenues  grow  more  slowly  than we  anticipate,  or if our  operating
expenses exceed its expectations, we may experience reduced profitability.

INDEPENDENT  OUTSIDE AUDITORS HAVE RAISED SUBSTANTIAL DOUBT ABOUT  IMMUNEREGEN'S
ABILITY TO CONTINUE AS A GOING CONCERN.

Our  independent  certified  public  accountants  have  stated  in their  report
included  in this Form  10-KSB  that the  Company  has  incurred  a net loss and
negative cash flows from operations of $5,955,688 and $1,482,107,  respectively,
for the period of  inception of October 30, 2002 to  September  30, 2004,  and a
lack of operational history,  among other matters,  that raise substantial doubt
about its ability to  continue as a going  concern,  which  contemplates,  among
other things,  the realization of assets and  satisfaction of liabilities in the
normal course of business. The effect of this going concern would materially and
adversely affect  ImmuneRegen's  ability to raise capital, its relationship with
potential suppliers and customers, and have other unforeseen effects.


WE MAY FAIL TO  BECOME  AND  REMAIN  PROFITABLE  OR WE MAY BE UNABLE TO FUND OUR
CONTINUING LOSSES, IN WHICH CASE OUR BUSINESS MAY FAIL.


hawse have focused on product  development  and has not generated any revenue to
date. We have incurred operating losses since our inception.


We currently have no product  candidates  for sale in the United States,  and we
cannot  guarantee  that we will  ever have  marketable  products  in the  United
States.  We must  demonstrate  that  our  product  candidates  satisfy  rigorous
standards of safety and efficacy before the FDA and other regulatory authorities
in the  United  States and abroad  will  approve  the  products  for  commercial
marketing. We will need to conduct significant additional research,  preclinical
testing and clinical  testing before we can file  applications  with the FDA for
approval of our product candidates.  In addition,  to compete  effectively,  our
future  products  must  be  easy  to  use,   cost-effective  and  economical  to
manufacture on a commercial scale. We may not achieve any of these objectives.

We expect to incur losses as we research,  develop and seek regulatory approvals
for our  products.  If our  products  fail in  clinical  trials  or do not  gain
regulatory  approval,  or if our products do not achieve market  acceptance,  we
will not be profitable. If we fail to become and remain profitable, or if we are
unable to fund our continuing losses, our business may fail.

OUR  OPERATING  EXPENSES  ARE  UNPREDICTABLE,  WHICH MAY  ADVERSELY  AFFECT  OUR
BUSINESS, OPERATIONS AND FINANCIAL CONDITION.

As a result of our limited  operating history and because of the emerging nature
of the markets in which we will compete,  our financial data is of limited value
in planning  future  operating  expenses.  To the extent our operating  expenses
precede or are not rapidly followed by increased revenue, our business,  results
of operations and financial condition may be materially adversely affected.  Our
expense  levels  will be based  in part on our  expectations  concerning  future
revenues. A significant portion of our revenue is anticipated to be derived from
Homspera; however the size and extent of such revenues are wholly dependent upon
the  choices  and  demand  of  individuals,  which  are  difficult  to  forecast
accurately.  We may be unable to adjust  our  operations  in a timely  manner to
compensate  for  any  unexpected  shortfall  in  revenues.   Further,   business
development and marketing  expenses may increase  significantly as we expand our
operations.


IF OUR PLAN IS NOT SUCCESSFUL OR MANAGEMENT IS NOT  EFFECTIVE,  THE VALUE OF OUR
COMMON STOCK MAY DECLINE.


Our operating subsidiary,  ImmuneRegen BioSciences, Inc., was founded in October
2002. As a result,  we are a development  stage company with a limited operating
history that makes it impossible to reliably predict future growth and operating
results. Our business and prospects must be considered in light of the risks and
uncertainties  frequently  encountered  by  companies  in their early  stages of
development. In particular, we have not demonstrated that we can:

   o  ensure  that  our  products   function  as  intended  in  human   clinical
      applications;

   o  obtain the regulatory  approvals necessary to commercialize  products that
      we may develop in the future;

   o  manufacture, or arrange for third-parties to manufacture,  future products
      in a manner that will enable us to be profitable;

   o  establish many of the business functions  necessary to operate,  including
      sales,  marketing,  administrative and financial functions,  and establish
      appropriate financial controls;

   o  make,  use, and sell future products  without  infringing upon third party
      intellectual property rights; or,

   o  respond effectively to competitive pressures.

We cannot be sure that we will be  successful in meeting  these  challenges  and
addressing  these  risks  and  uncertainties.  If we are  unable  to do so,  our
business will not be successful.

WE WILL BE REQUIRED TO RAISE  ADDITIONAL  CAPITAL TO FUND OUR OPERATIONS.  IF WE
CANNOT RAISE  NEEDED  ADDITIONAL  CAPITAL IN THE FUTURE,  WE WILL BE REQUIRED TO
CEASE OPERATIONS.

We require substantial  working capital to fund our operations.  Since we do not
expect to generate  significant  revenues in the foreseeable future, in order to
fund operations,  we will be completely  dependent on additional debt and equity
financing arrangements.  As of September 30, 2004, our cash and cash equivalents
totaled  approximately  $(2,853) in  deficit.  Based on our  current  plans,  we
believe  these  financial  resources,  and  interest  earned  thereon,  will  be

                                       9

<PAGE>

sufficient to meet our operating expenses and capital  requirements for at least
the next 30 days. There is no assurance that any financing will be sufficient to
fund our capital  expenditures,  working capital and other cash requirements for
the fiscal year ending  December  31, 2004.  No assurance  can be given that any
such additional funding will be available or that, if available, can be obtained
on terms  favorable to us. If we are unable to raise needed funds on  acceptable
terms, we will not be able to develop or enhance our products, take advantage of
future  opportunities  or  respond to  competitive  pressures  or  unanticipated
requirements.  A material  shortage of capital  will  require us to take drastic
steps such as reducing our level of operations,  disposing of selected assets or
seeking an acquisition partner. If cash is insufficient,  we will not be able to
continue operations.

We expect to require  substantial  additional funds in order to finance our drug
discovery and development programs,  fund operating expenses,  pursue regulatory
clearances,  develop  manufacturing,   marketing  and  sales  capabilities,  and
prosecute and defend our intellectual  property  rights.  We may seek additional
funding   through   public  or  private   financing  or  through   collaborative
arrangements with strategic partners.

You should be aware that in the future:

   o  we may not obtain  additional  financial  resources  when  necessary or on
      terms favorable to us, if at all; and,

   o  any available additional financing may not be adequate.

If we cannot raise additional funds when needed, or on acceptable terms, we will
not be able to continue to develop our drug candidates.  We require  substantial
working  capital  to fund our  operations.  Since we do not  expect to  generate
significant revenues in the foreseeable future, in order to fund operations,  we
will  be  completely   dependent  on  additional   debt  and  equity   financing
arrangements.  There is no assurance  that any  financing  will be sufficient to
fund our capital  expenditures,  working capital and other cash requirements for
the  next  12  months.  Our  working  capital  as  of  September  30,  2004  was
$(1,947,049). No assurance can be given that any such additional funding will be
available or that, if available, can be obtained on terms favorable to us. If we
are unable to raise needed  funds on  acceptable  terms,  we will not be able to
develop or enhance our  products,  take  advantage  of future  opportunities  or
respond to  competitive  pressures  or  unanticipated  requirements.  A material
shortage of capital will  require us to take drastic  steps such as reducing our
level of  operations,  disposing  of selected  assets or seeking an  acquisition
partner. If cash is insufficient, we will not be able to continue operations.


ALL OUR  APPLICATIONS  ARE ALL DERIVED FROM THE USE OF HOMSPERA.  IF HOMSPERA IS
FOUND TO BE UNSAFE OR INEFFECTIVE, WE WOULD HAVE NO POTENTIAL SOURCE OF REVENUES
AND MAY BE REQUIRED TO CEASE OPERATIONS.

All  our  potential  applications  are  derived  from  the use of  Homspera.  In
addition,  we  expect to  utilize  Homspera  in the  development  of any  future
products we market. If these current or future Homspera-based products are found
to be unsafe or ineffective due to the use of Homspera, we may have to modify or
cease  production of the products.  As all of our  applications  utilize or will
utilize  Homspera,  any findings  that Homspera is unsafe or  ineffective  would
severely harm our Homspera-based  business operations,  since all of our primary
revenue sources would be negatively affected by such findings. In such an event,
we may be required to cease operations.

We will need to conduct significant additional research, preclinical testing and
clinical  testing before we can file  applications  with the FDA for approval of
our product candidates.

         To date we have not yet  made  applications  with the FDA or any  other
governmental  regulatory agency for approval for our product  candidates.  Until
such as time as our  New  Drug  Application  (NDA)  is  filed  and  subsequently
approved, we will not be able to manufacture products.

         Our  research  and  preclinical   testing  is  currently   directed  in
developing products candidates based on our proprietary  compound,  Homspera. We
have  demonstrated in early  preclinical  studies evidence that may suggest that
Homspera may be used to treat the suppression of the body's immune system caused
by exposure to various forms of radiation,  toxic inhalants and viral infectious
diseases.  As a research and  development  company,  we may,  from time to time,
pursue the  development of other  products based on discoveries  made during our
studies.

         We   intend   to  begin  our   preparations   for  the   filing  of  an
Investigational  New Drug Application  (IND). We expect the IND to be filed with
the FDA within the next 24 months. We anticipate commencing a study in non-human
primates in  conjunction  with the filing of the IND. We expect this study to be
completed within 24 to 30 months.  Based on positive study results, we expect to
file a New Drug Application (NDA) with the FDA within the next 36 months.


IF WE FAIL TO SUCCESSFULLY DEVELOP AND COMMERCIALIZE  PRODUCTS,  WE WILL HAVE TO
CEASE OPERATIONS.

Our failure to develop and commercialize  products successfully will cause us to
cease  operations.  Our  potential  therapies  utilizing  Homspera  will require
significant additional research and development efforts and regulatory approvals
prior to potential commercialization in the future. We cannot guarantee that we,
or our  corporate  collaborators,  if  any,  will  ever  obtain  any  regulatory
approvals of  Homspera.  We currently  are  focusing  our core  competencies  on
Homspera  although  there may be no assurance  that we will be  successful in so
doing.

Our  therapies  and  technologies  utilizing  Homspera  is at  early  stages  of
development  and may not be shown to be safe or effective  and may never receive
regulatory  approval.  Our  technologies  utilizing  Homspera  have not yet been
tested in  humans.  Regulatory  authorities  may not  permit  human  testing  of
potential  products  based  on these  technologies.  Even if  human  testing  is
permitted,  any  potential  products  based on Homspera may not be  successfully
developed or shown to be safe or effective.

The results of our preclinical studies and clinical trials may not be indicative
or future  clinical  trial  results.  A commitment of  substantial  resources to
conduct time-consuming research, preclinical studies and clinical trials will be
required if we are to develop any products. Delays in planned patient enrollment
in our clinical  trials may result in increased  costs,  program delays or both.
None of our  potential  products  may prove to be safe or  effective in clinical
trials. Approval of the Unites States Food and Drug Administration,  the FDA, or
other regulatory  approvals,  including export license  permissions,  may not be
obtained and even if successfully developed and approved, our potential products
may not achieve market acceptance.  Any products resulting from our programs may
not be successfully  developed or commercially  available for a number of years,
if at all.

Moreover,  unacceptable  toxicity or side effects could occur at any time in the
course of human clinical trials or, if any products are  successfully  developed
and  approved  for  marketing,  during  commercial  use of  any of our  proposed
products.  The  appearance  of any  unacceptable  toxicity or side effects could
interrupt, limit, delay or abort the development of any of our proposed products
or, if previously approved, necessitate their withdrawal from the market.

                                       10

<PAGE>


THE MARKET FOR TREATING  ACUTE  RADIATION  SYNDROME IS  UNCERTAIN  AND IF WE ARE
UNABLE  TO  SUCCESSFULLY   COMMERCIALIZE  HOMSPERA,  WE  WILL  NOT  RECOGNIZE  A
SIGNIFICANT PORTION OF OUR PLANNED REVENUES.

We do not believe any drug has ever been  approved  and  commercialized  for the
treatment of severe  acute  radiation  injury.  In  addition,  the  incidence of
large-scale   exposure  to  nuclear  or   radiological   events  has  been  low.
Accordingly,  even if Homspera, our lead drug candidate to treat Acute Radiation
Syndrome (ARS), is approved by the FDA, we cannot predict with any certainty the
size of this market.  The potential  market is largely  dependent on the size of
stockpiling orders, if any, procured by the U.S. and foreign governments.  While
a number of governments have historically  stockpiled drugs to treat indications
such as smallpox,  anthrax  exposure,  plague,  tularemia and certain  long-term
effects of radiation  exposure,  we are unaware of any  significant  stockpiling
orders for drugs to treat ARS. While we have filed a formal response to the U.S.
Department  of Health  and Human  Services  Request  for  Information  (RFI) for
therapeutics to treat ARS, at least one other company has responded to this RFI,
and we cannot  guarantee  that our  response  to this RFI will  result in a U.S.
Department  of Health  and Human  Services  Request  for  Proposal  (RFP) or any
stockpiling orders. A decision by the U.S. Government to enter into a commitment
to purchase  Homspera  prior to FDA approval is largely out of our control.  Our
development plans and timelines may vary  substantially  depending on whether we
receive such a commitment and the size of such commitment,  if any. In addition,
even if Homspera is approved by regulatory authorities, we cannot guarantee that
we will receive any stockpiling  orders for Homspera,  that any such order would
be  profitable  to us or that  Homspera  will achieve  market  acceptance by the
general public.

THE LENGTHY PRODUCT  APPROVAL  PROCESS AND UNCERTAINTY OF GOVERNMENT  REGULATORY
REQUIREMENTS MAY DELAY OR PREVENT US FROM COMMERCIALIZING PROPOSED PRODUCTS, AND
THEREFORE ADVERSELY AFFECT THE TIMING AND LEVEL OF FUTURE REVENUES, IF ANY.

The process of obtaining FDA and other  regulatory  approvals is time consuming,
expensive and difficult to design and  implement.  Clinical  trials are required
and the marketing and  manufacturing of our applications are subject to rigorous
testing  procedures.  Significant  delays in  clinical  trials  will  impede our
ability  to  commercialize  our  applications  and  generate  revenue  and could
significantly increase our development costs. The commencement and completion of
clinical trials for our  Homspera-based  applications or any of our applications
could be delayed or prevented by a variety of factors, including:

         o  delays in obtaining regulatory approvals to commence a study;

         o  delays in  identifying  and reaching  agreement on acceptable  terms
            with prospective clinical trial sites;

         o  delays in the enrollment of patients;

         o  lack of efficacy during clinical trials; or,

         o  unforeseen safety issues.

         Even if marketing approval from the FDA is received, the FDA may impose
post-marketing requirements, such as:

         o  labeling and advertising requirements,  restrictions or limitations,
            including the inclusion of warnings, precautions, contra-indications
            or use  limitations  that could have a material impact on the future
            profitability of our applications;

         o  testing and  surveillance  to monitor our future  products and their
            continued compliance with regulatory requirements;

         o  submitting  products for inspection  and, if any inspection  reveals
            that the product is not in compliance,  prohibiting  the sale of all
            products;

         o  suspending manufacturing; or

         o  withdrawing marketing clearance.

Additionally,   the  FDA's  policies  may  change  and   additional   government
regulations may be enacted,  which could prevent or delay regulatory approval of
our applications.  We cannot predict the likelihood, nature or extent of adverse
government  regulation that may arise from future  legislation or administrative
action,  either in the United  States or abroad.  If we are not able to maintain
regulatory  compliance,  we might not be permitted to market our future products
and our business could suffer.


Even if human  clinical  trials  of  Homspera  are  initiated  and  successfully
completed,  the  FDA  may not  approve  Homspera  for  commercial  sale.  We may
encounter  significant  delays  or  excessive  costs in our  efforts  to  secure
necessary approvals.  Regulatory requirements are evolving and uncertain. Future
United States or foreign  legislative or administrative  acts could also prevent
or delay regulatory  approval of our products.  We may not be able to obtain the
necessary  approvals for clinical  trials,  manufacturing or marketing of any of
our products  under  development.  Even if commercial  regulatory  approvals are
obtained,  they may include  significant  limitations  on the indicated uses for
which a product may be marketed.

The FDA has not designated expanded access protocols for Homspera as "treatment"
protocols.  The FDA may not  determine  that  Homspera  meets  all of the  FDA's
criteria for use of an investigational  drug for treatment use. Even if Homspera
is allowed for treatment use,  third party payers may not provide  reimbursement
for the costs of treatment with Homspera. The FDA also may not consider Homspera
to be an appropriate  candidate for accelerated  approval,  expedited  review or
fast track designation.

                                       11

<PAGE>


IF WE FAIL TO OBTAIN APPROVAL FROM FOREIGN REGULATORY  AUTHORITIES,  WE WILL NOT
BE  ALLOWED  TO MARKET OR SELL OUR  PRODUCTS  IN OTHER  COUNTRIES,  WHICH  WOULD
ADVERSELY AFFECT OUR LEVELS OF FUTURE REVENUES, IF ANY.


Marketing  any drug  products  outside of the United  States will  subject us to
numerous and varying foreign  regulatory  requirements  governing the design and
conduct of human  clinical  trials and  marketing  approval.  Additionally,  our
ability to export  drug  candidates  outside the United  States on a  commercial
basis will be subject to the receipt  from the FDA of export  permission,  which
may not be available on a timely basis, if at all.

Approval procedures vary among countries and can involve additional testing, and
the time required to obtain approval may differ from that required to obtain FDA
approval.  Foreign  regulatory  approval  processes  include  all of  the  risks
associated with obtaining FDA approval set forth above,  and approval by the FDA
does not ensure approval by the health authorities of any other country.


CLINICAL  TRIALS  MAY  FAIL  TO  DEMONSTRATE  THE  SAFETY  AND  EFFICACY  OF OUR
APPLICATIONS, WHICH COULD PREVENT OR SIGNIFICANTLY DELAY REGULATORY APPROVAL.


Prior  to  receiving  approval  to  commercialize  any  of our  applications  or
therapies,  we must demonstrate with substantial  evidence from  well-controlled
clinical  trials,  and to the  satisfaction  of the  FDA  and  other  regulatory
authorities in the United States and abroad, that our applications are both safe
and  effective.  We will need to  demonstrate  our  applications'  efficacy  and
monitor their safety  throughout the process.  If any future clinical trials are
unsuccessful,  our business and  reputation  would be harmed and our stock price
would be adversely affected.

All of our  applications  are prone to the risks of failure inherent in biologic
development.  The results of early-stage  clinical trials of our applications do
not necessarily predict the results of later-stage clinical trials. Applications
in  later-stage  clinical  trials may fail to show  desired  safety and efficacy
traits despite having progressed  through initial clinical  testing.  Even if we
believe  the  data  collected  from  clinical  trials  of  our  applications  is
promising, this data may not be sufficient to support approval by the FDA or any
other U.S. or foreign regulatory approval.  Preclinical and clinical data can be
interpreted in different ways.  Accordingly,  FDA officials could interpret such
data  in  different  ways  than we do,  which  could  delay,  limit  or  prevent
regulatory approval. The FDA, other regulatory authorities, or we may suspend or
terminate  clinical  trials at any time.  Any  failure or  significant  delay in
completing  clinical  trials for our  applications,  or in receiving  regulatory
approval  for the sale of any  products  resulting  from our  applications,  may
severely harm our business and reputation.

DELAYS IN THE CONDUCT OR COMPLETION OF OUR  PRECLINICAL  OR CLINICAL  STUDIES OR
THE ANALYSIS OF THE DATA FROM OUR PRECLINICAL OR CLINICAL  STUDIES MAY RESULT IN
DELAYS IN OUR PLANNED FILINGS FOR REGULATORY APPROVALS,  OR ADVERSELY AFFECT OUR
ABILITY TO ENTER INTO COLLABORATIVE ARRANGEMENTS.

We may encounter  problems with some or all of our completed or ongoing  studies
that may cause us or  regulatory  authorities  to delay or suspend  our  ongoing
studies or delay the analysis of data from our completed or ongoing studies.  If
the results of our ongoing and planned  studies for our drug  candidates are not
available  when we expect or if we  encounter  any delay in the  analysis of the
results of our studies for our drug candidates:

         o  we may not have the  financial  resources  to continue  research and
            development of any of our drug candidates; and,

         o  we may not be able to enter into collaborative arrangements relating
            to any drug candidate subject to delay in regulatory filing.

Any of  the  following  reasons,  among  others,  could  delay  or  suspend  the
completion of our ongoing and future studies:

         o  delays in enrolling volunteers;

         o  interruptions  in the  manufacturing of our drug candidates or other
            delays in the delivery of materials  required for the conduct of our
            studies;

         o  lower than anticipated retention rate of volunteers in a trial;

         o  unfavorable efficacy results;

         o  serious side effects  experienced by study participants  relating to
            the drug candidate;

         o  new  communications  from  regulatory  agencies about how to conduct
            these studies; or,

         o  failure to raise additional funds.

IF  THE   MANUFACTURERS  OF  OUR  PRODUCTS  DO  NOT  COMPLY  WITH  CURRENT  GOOD
MANUFACTURING PRACTICES REGULATIONS, OR CANNOT PRODUCE THE AMOUNT OF PRODUCTS WE
NEED  TO  CONTINUE  OUR  DEVELOPMENT,  WE  WILL  FALL  BEHIND  ON  OUR  BUSINESS
OBJECTIVES.

Manufacturers   producing  our  drug   candidates   must  follow   current  Good
Manufacturing  Practices,  or GMP,  regulations  enforced by the FDA and foreign
equivalents.  If a manufacturer  of our drug  candidates does not conform to the
GMP regulations and cannot be brought up to such a standard, we will be required
to find  alternative  manufacturers  that do  conform.  This  may be a long  and
difficult  process,  and  may  delay  our  ability  to  receive  FDA or  foreign
regulatory approval of our products.

We also rely on our manufacturers to supply us with a sufficient quantity of our
drug candidates to conduct clinical trials.  If we have difficulty in the future
obtaining  our  required  quantity  and quality of supply,  we could  experience
significant delays in our development programs and regulatory process.


OUR  LACK  OF  COMMERCIAL  MANUFACTURING,   SALES,  DISTRIBUTION  AND  MARKETING
EXPERIENCE  MAY PREVENT US FROM  SUCCESSFULLY  COMMERCIALIZING  PRODUCTS,  WHICH
WOULD ADVERSELY AFFECT OUR LEVEL OF FUTURE REVENUES, IF ANY.

The  manufacturing  process of our  proposed  products  is expected to involve a
number  of  steps  and  requires   compliance  with  stringent  quality  control
specifications imposed by us and by the FDA. We have no experience in the sales,
marketing and distribution of pharmaceutical or biotechnology  products. We have
not  manufactured  any of our  products  in  commercial  quantities.  We may not
successfully  arrange for contract  manufacturing  of our products in production
quantities and this could prevent us from commercializing  products or limit our
profitability from our products.


                                       12

<PAGE>

WE RELY ON THIRD  PARTY  MANUFACTURERS  FOR THE  MANUFACTURE  OF  HOMSPERA.  OUR
INABILITY TO MANUFACTURE HOMSPERA, AND OUR DEPENDENCE ON SUCH MANUFACTURERS, MAY
DELAY OR IMPAIR OUR  ABILITY  TO  GENERATE  REVENUES,  OR  ADVERSELY  AFFECT OUR
PROFITABILITY.

We may enter into arrangements with contract manufacturing companies in order to
meet  requirements  for our  products  or to attempt  to  improve  manufacturing
efficiency.  If we  choose  to  contract  for  manufacturing  services,  we  may
encounter costs,  delays and/or other  difficulties in producing,  packaging and
distributing  our  clinical  trials  and  finished  product.  Further,  contract
manufacturers must also operate in compliance with the GMP requirements; failure
to do so could  result in, among other  things,  the  disruption  of our product
supplies. Our potential dependence upon third parties for the manufacture of our
proposed  products may  adversely  affect our profit  margins and our ability to
develop and deliver proposed products on a timely and competitive basis. For the
manufacture of the applications under development,  we obtain synthetic peptides
from third party  manufacturers.  A  synthesized  version of Homspera is readily
available at low cost from several life science and  technology  companies  that
provide  biochemical and organic  chemical  products and kits used in scientific
and  genomic  research,   biotechnology,   pharmaceutical  development  and  the
diagnosis  of  disease  and  chemical  manufacturing.  If any of these  proposed
manufacturing  operations prove  inadequate,  there may be no assurance that any
other  arrangements  may be  established  on a  timely  basis  or that we  could
establish other manufacturing  capacity on a timely basis.  Although, we believe
that the synthetic substance P and other materials necessary to produce Homspera
are readily available from various sources, and several suppliers are capable of
supplying substance P in both clinical and commercial quantities, our dependence
on such manufacturers,  may delay or impair our ability to generate revenues, or
adversely affect our profitability.


ADVERSE  DETERMINATIONS  CONCERNING  PRODUCT PRICING,  REIMBURSEMENT AND RELATED
MATTERS COULD PREVENT US FROM SUCCESSFULLY COMMERCIALIZING HOMSPERA, WHICH WOULD
ADVERSELY AFFECT OUR LEVEL OF FUTURE REVENUES, IF ANY.


Our  ability  to earn  sufficient  revenue  on  Homspera  or any other  proposed
products will depend in part on the extent to which  reimbursement for the costs
of such products and related treatments will be available from government health
administration  authorities,  private  health  coverage  insurers,  managed care
organizations   and  other   organizations.   Failure   to  obtain   appropriate
reimbursement may prevent us from successfully  commercializing  Homspera or any
proposed products. Third-party payers are increasingly challenging the prices of
medical  products and  services.  If purchasers or users of Homspera or any such
other proposed  products are not able to obtain adequate  reimbursement  for the
cost of using such  products,  they may forego or reduce their use.  Significant
uncertainty exists as to the reimbursement  status of newly approved health care
products and whether adequate third party coverage will be available.


THE MEDICAL COMMUNITY MAY NOT ACCEPT AND UTILIZE  HOMSPERA,  THE EFFECT OF WHICH
WOULD PREVENT US FROM SUCCESSFULLY  COMMERCIALIZING  THE PRODUCT,  AND ADVERSELY
AFFECT OUR LEVEL OF FUTURE REVENUE, IF ANY.


Our ability to market and  commercialize  Homspera depends on the acceptance and
utilization  of  Homspera  by the  medical  community.  We will need to  develop
commercialization  initiatives  designed  to  increase  awareness  about  us and
Homspera  among  targeted  audiences,  including  public  health  activists  and
community-based outreach groups in addition to the investment community.

Currently,  we have not developed any such initiatives.  Without such acceptance
of Homspera, the product upon which we expect to be substantially  dependent, we
may not be able to successfully commercialize Homspera or generate revenue.


PRODUCT  LIABILITY  EXPOSURE  MAY EXPOSE US TO  SIGNIFICANT  LIABILITY OR COSTS,
WHICH WOULD ADVERSELY IMPART OUR FUTURE OPERATING  RESULTS AND DIVERT FUNDS FROM
THE OPERATION OF OUR BUSINESS.


We face an inherent  business  risk of exposure to product  liability  and other
claims and lawsuits in the event that the  development  or use of our technology
or prospective  products is alleged to have resulted in adverse effects.  We may
not be able to avoid significant  liability exposure. We may not have sufficient
insurance  coverage  and we may not be able to obtain  sufficient  coverage at a
reasonable  cost.  An  inability  to  obtain  product  liability   insurance  at
acceptable cost or to otherwise  protect  against  potential  product  liability
claims could prevent or inhibit the commercialization of our products. A product
liability  claim  could  hurt  our  financial  performance.  Even  if we  avoids
liability  exposure,  significant  costs could be  incurred  that could hurt our
financial performance.


WE MAY FAIL TO PROTECT ADEQUATELY OUR PROPRIETARY TECHNOLOGY,  WHICH WOULD ALLOW
COMPETITORS  TO TAKE  ADVANTAGE  OF OUR RESEARCH AND  DEVELOPMENT  EFFORTS,  THE
EFFECT OF WHICH COULD ADVERSELY AFFECT ANY COMPETITIVE ADVANTAGE WE MAY HAVE.


We own or have  obtained a license to 4 issued U.S.  and  foreign  patents and 8
pending U.S. and foreign patent applications. Our success will depend in part on
our ability to obtain additional United States and foreign patent protection for
our drug  candidates  and  processes,  preserve  our trade  secrets  and operate
without   infringing  the  proprietary   rights  of  third  parties.   We  place
considerable  importance on obtaining  patent  protection  for  significant  new
technologies, products and processes.

Our long-term  success largely depends on our ability to market  technologically
competitive  processes  and  products.  If we fail to obtain or  maintain  these
protections  we may  not be  able  to  prevent  third  parties  from  using  our
proprietary  rights. Our currently pending or future patent applications may not
result  in  issued  patents.  In the  United  States,  patent  applications  are
confidential  until patent  applications  are published or the patent is issued,
and because  third  parties may have filed patent  applications  for  technology
covered by our  pending  patent  applications  without  us being  aware of those
applications,  our patent  applications  may not have  priority  over any patent
applications of others.  In addition,  our issued patents may not contain claims
sufficiently broad to protect us against third parties with similar technologies
or  products  or provide us with any  competitive  advantage.  If a third  party
initiates  litigation  regarding our patents,  and is successful,  a court could
revoke  our  patents or limit the scope of  coverage  for those  patents.  Legal
standards  relating  to the  validity  of patents  covering  pharmaceutical  and
biotechnology  inventions  and the scope of claims  made under such  patents are
still  developing.  In some of the  countries  in which we intend to market  our
products, pharmaceuticals are either not patentable or have only recently become
patentable.  Past  enforcement of intellectual  property rights in many of these
countries has been limited or  non-existent.  Future  enforcement of patents and
proprietary  rights in many other countries may be problematic or unpredictable.
Moreover,  the  issuance of a patent in one country does not assure the issuance
of a similar patent in another country.  Claim  interpretation  and infringement
laws vary by nation, so the extent of any patent protection is uncertain and may
vary in different jurisdictions.

The U.S. Patent and Trademark Office, commonly referred to as the USPTO, and the
courts  have  not  consistently   treated  the  breadth  of  claims  allowed  in
biotechnology patents. If the USPTO or the courts begin to allow broader claims,
the  incidence  and  cost of  patent  interference  proceedings  and the risk of

                                       13

<PAGE>

infringement litigation will likely increase. On the other hand, if the USPTO or
the courts begin to allow narrower claims,  the value of our proprietary  rights
may be limited. Any changes in, or unexpected interpretations of the patent laws
may adversely affect our ability to enforce our patent position.

We  also  rely  upon  trade   secrets,   proprietary   know-how  and  continuing
technological innovation to remain competitive. We protect this information with
reasonable  security measures,  including the use of confidentiality  agreements
with our employees, consultants and corporate collaborators. It is possible that
these  individuals  will breach  these  agreements  and that any  remedies for a
breach will be insufficient to allow us to recover our costs.  Furthermore,  our
trade secrets,  know-how and other  technology may otherwise  become known or be
independently discovered by our competitors.

OUR PATENTS AND  PROPRIETARY  TECHNOLOGY MAY NOT BE ENFORCEABLE  AND THE PATENTS
AND  PROPRIETARY  TECHNOLOGY  OF  OTHERS  MAY  PREVENT  US FROM  COMMERCIALIZING
PRODUCTS.

Although we believe our inventions to be protected and our patents  enforceable,
the failure to obtain meaningful patent protection  products and processes would
greatly diminish the value of our potential products and processes.

In addition,  whether or not our applications are issued, or issued with limited
coverage,  others may receive  patents,  which contain claims  applicable to our
products.  Patents  we are not aware of may  adversely  affect  our  ability  to
develop and commercialize products.

The patent positions of  biotechnology  and  pharmaceutical  companies are often
highly uncertain and involve complex legal and factual questions. Therefore, the
breadth of claims allowed in biotechnology and pharmaceutical  patents cannot be
predicted. We also rely upon non-patented trade secrets and know how, and others
may independently develop substantially equivalent trade secrets or know how. We
also  rely  on   protecting   our   proprietary   technology   in  part  through
confidentiality  agreements with our current and former corporate collaborators,
employees,   consultants  and  certain  contractors.  These  agreements  may  be
breached,  and  we may  not  have  adequate  remedies  for  any  such  breaches.
Litigation may be necessary to defend against claims of infringement, to enforce
our patents or to protect trade secrets.  Litigation or other disputes regarding
patents and other proprietary rights may be expensive,  cause delays in bringing
products  to market and harm our  ability to operate.  In  addition,  litigation
could result in substantial costs and diversion of management efforts regardless
of the results of the litigation.  An adverse result in litigation could subject
us to significant  liabilities to third parties,  require  disputed rights to be
licensed or require us to cease using certain technologies.

Our products could infringe on the intellectual property rights of others, which
may cause us to engage in costly litigation and, if not successful,  could cause
us to pay substantial damages and prohibit us from selling our products. Because
patent  applications  in the United States are not publicly  disclosed until the
patent  application is published or the patent is issued,  applications may have
been filed which  relate to products  similar to those  offered by us. We may be
subject to legal proceedings and claims from time to time in the ordinary course
of our business,  including claims of alleged infringement of the trademarks and
other intellectual property rights of third parties.

If our products violate  third-party  proprietary  rights,  we cannot assure you
that we would be able to  arrange  licensing  agreements  or other  satisfactory
resolutions on commercially reasonable terms, if at all. Any claims made against
us relating to the infringement of third-party  propriety rights could result in
the   expenditure  of  significant   financial  and  managerial   resources  and
injunctions preventing us from developing and commercializing our products. Such
claims could severely harm our financial condition and ability to compete.

In addition,  if another party claims the same subject  matter or subject matter
overlapping  with the  subject  matter that we have  claimed in a United  States
patent  application  or patent,  we may decide or be required to  participate in
interference  proceedings  in the United States  Patent and Trademark  Office in
order to  determine  the  priority of  invention.  Loss of such an  interference
proceeding would deprive us of patent protection  sought or previously  obtained
and could prevent us from  commercializing  our products.  Participation in such
proceedings  could  result in  substantial  costs,  whether or not the  eventual
outcome  is  favorable.  These  additional  costs  could  adversely  affect  our
financial results.


FAILURE TO COMPLY WITH  ENVIRONMENTAL  LAWS OR  REGULATIONS  COULD  EXPOSE US TO
SIGNIFICANT  LIABILITY  OR COSTS  WHICH  WOULD  ADVERSELY  IMPART OUR  OPERATING
RESULTS AND DIVERT FUNDS FROM THE  OPERATION OF OUR BUSINESS AND HAVE A MATERIAL
ADVERSE EFFECT ON OUR BUSINESS.


We may be required to incur  significant  costs to comply with current or future
environmental  laws and  regulations.  Although we do not currently  manufacture
commercial quantities of our proposed products, we do produce limited quantities
of these  products for our clinical  trials.  Our research and  development  and
manufacturing  processes  involve the  controlled  storage,  use and disposal of
hazardous materials,  biological hazardous materials and radioactive  compounds.
We are subject to federal,  state and local laws and  regulations  governing the
use,  manufacture,  storage,  handling and disposal of these  materials and some
waste products.  Although we believe that our safety procedures for handling and
disposing of these materials comply with the standards  prescribed by these laws
and regulations, the risk of contamination or injury from these materials cannot
be completely eliminated. In the event of an incident,  ImmuneRegen BioSciences,
Inc. could be held liable for any damages that result,  and any liability  could
exceed our resources.  Current or future  environmental  laws or regulations may
have a material adverse effect on our operations, business and assets.

WE DEPEND ON THE CONTINUED  SERVICES OF OUR EXECUTIVE OFFICERS AND THE LOSS OF A
KEY EXECUTIVE COULD SEVERELY IMPACT OUR OPERATIONS.

The execution of our present business plan depends on the continued  services of
Michael K. Wilhelm,  our Chief Executive Officer and President,  Mark L. Witten,
Ph.D., our acting Chief Scientific Officer. We do not currently maintain key-man
insurance on their lives. While we have entered into employment  agreements with
each of them,  the loss of any of their  services would be detrimental to us and
could have a material  adverse effect on our business,  financial  condition and
results of operations.

OUR  EXECUTIVE  OFFICERS,  DIRECTORS  AND  PRINCIPAL  STOCKHOLDERS  CONTROL  OUR
BUSINESS AND MAY MAKE DECISIONS THAT ARE NOT IN OUR BEST INTERESTS.

Our officers, directors and principal stockholders, and their affiliates, in the
aggregate, own over a majority of the outstanding shares of our common stock. As
a result,  such  persons,  acting  together,  have the ability to  substantially
influence all matters submitted to our stockholders for approval,  including the
election and removal of directors and any merger,  consolidation  or sale of all
or substantially  all of our assets,  and to control our management and affairs.
Accordingly,

                                       14

<PAGE>

such  concentration  of ownership may have the effect of delaying,  deferring or
preventing a change in  discouraging  a potential  acquirer form making a tender
offer or otherwise attempting to obtain control of our business,  even if such a
transaction would be beneficial to other stockholders.

TRADING IN OUR SECURITIES  COULD BE SUBJECT TO EXTREME PRICE  FLUCTUATIONS  THAT
COULD ADVERSELY AFFECT YOUR INVESTMENT.

The market prices for securities of life sciences companies,  particularly those
that  are not  profitable,  have  been  highly  volatile,  especially  recently.
Publicized events and announcements may have a significant  impact on the market
price of our common stock. For example:

         o  biological or medical discoveries by competitors;

         o  public concern about the safety of our drug candidates;

         o  delays in the  conduct or analysis  of our  preclinical  or clinical
            studies;

         o  unfavorable results from preclinical or clinical studies;

         o  unfavorable  developments  concerning  patents or other  proprietary
            rights; or

         o  unfavorable domestic or foreign regulatory developments;

may have the effect of temporarily or permanently  driving down the price of our
common  stock.  In  addition,  the stock  market  from time to time  experiences
extreme  price and  volume  fluctuations  which  particularly  affect the market
prices for emerging and life  sciences  companies,  such as ours,  and which are
often  unrelated to the operating  performance  of the affected  companies.  For
example,  our stock price has ranged from $0.01 to $4.50 between January 1, 2003
and September 30, 2004.

These  broad  market   fluctuations  may  adversely  affect  the  ability  of  a
stockholder  to dispose of his shares at a price  equal to or above the price at
which the shares were purchased.  In addition, in the past, following periods of
volatility   in  the  market  price  of  a  company's   securities,   securities
class-action  litigation  has often been  instituted  against that company.  Any
litigation against our company, including this type of litigation,  could result
in substantial  costs and a diversion of  management's  attention and resources,
which could materially  adversely affect our business,  financial  condition and
results of operations.


A LIMITED  PRIOR PUBLIC  MARKET AND TRADING  MARKET MAY CAUSE  VOLATILITY IN THE
PRICE  OF OUR  COMMON  STOCK,  AND  THUS  ADVERSELY  AFFECT  THE  VALUE  OF YOUR
INVESTMENT.


Our common  stock is  currently  traded on a limited  basis on the OTC  Bulletin
Board (the  "OTCBB")  under the  symbol  "IRBO".  The OTCBB is an  inter-dealer,
Over-The-Counter  market that provides  significantly  less  liquidity  than the
NASDAQ Stock Market.  Quotes for stocks  included on the OTCBB are not listed in
the  financial  sections of newspapers as are those for the NASDAQ Stock Market.
Therefore,  prices for securities traded solely on the OTCBB may be difficult to
obtain and holders of common stock may be unable to resell their  securities  at
or near their  original  offering  price or at any price.  The NASD has  enacted
recent changes that limit  quotations on the OTC Bulletin Board to securities of
issuers that are current in their reports filed with the Securities and Exchange
Commission. The effect on the OTC Bulletin Board of these rule changes and other
proposed changes cannot be determined at this time.

The  quotation  of our  common  stock  on  the  OTCBB  does  not  assure  that a
meaningful, consistent and liquid trading market currently exists, and in recent
years such market has  experienced  extreme price and volume  fluctuations  that
have particularly  affected the market prices of many smaller companies like us.
Our common stock is thus subject to this volatility.


SALES OR ISSUANCES OF ADDITIONAL  EQUITY  SECURITIES  MAY  ADVERSELY  AFFECT THE
MARKET PRICE OF OUR COMMON STOCK AND YOUR RIGHTS IN US MAY BE REDUCED.


We expect to continue to incur  product  development  and  selling,  general and
administrative costs, and in order to satisfy our funding requirements,  we will
need to sell  additional  equity  securities,  which may be  subject  to similar
registration rights. The sale or the proposed sale of substantial amounts of our
common stock in the public markets may adversely  affect the market price of our
common stock.

From time to time,  certain  stockholders of our company may be eligible to sell
all or some of their  shares  of  common  stock by means of  ordinary  brokerage
transactions in the open market pursuant to Rule 144,  promulgated under the Act
("Rule 144"), subject to certain limitations.  In general, pursuant to Rule 144,
a stockholder (or stockholders  whose shares are aggregated) who has satisfied a
one-year  holding  periods may,  under  certain  circumstances,  sell within any
three-month  period a number of securities  which does not exceed the greater of
1% of the then  outstanding  shares of our common  stock or the  average  weekly
trading  volume of the class during the four calendar  weeks prior to such sale.
Rule 144 also permits,  under  certain  circumstances,  the sale of  securities,
without any  limitations,  by a non-affiliate of our company who has satisfied a
two-year  holding period.  Any substantial  sale of our common stock pursuant to
Rule 144 or pursuant to any resale  prospectus may have an adverse effect on the
market price of our securities.

Our  stockholders  may  experience  substantial  dilution and a reduction in the
price  that they are able to obtain  upon sale of their  shares.  Also,  any new
equity securities issued, including any new series of preferred stock authorized
by our board of directors,  may have greater  rights,  preferences or privileges
than our  existing  common  stock.  To the extent stock is issued or options and
warrants  are  exercised,  holders of our common stock will  experience  further
dilution.  In addition,  as in the case of the  warrants,  in the event that any
future  financing  should be in the form of, be convertible into or exchangeable
for, equity  securities and upon the exercise of options and warrants,  security
holders may experience additional dilution.

                                       15

<PAGE>

                           PART II - OTHER INFORMATION


ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K


(a) Exhibits

31.1     Certification  of  Chief  Executive   Officer  pursuant  to  Securities
         Exchange Act Rule 13a-14(a).

31.2     Certification  of  Chief  Financial   Officer  pursuant  to  Securities
         Exchange Act Rule 13a-14(a).

32       Certification  pursuant to U.S.C.  1350, as adopted pursuant to Section
         906 of the Sarbanes-Oxley Act of 2002.*

(b) Reports on Form 8-K

None.

* This  exhibit  shall not be deemed  "filed" for  purposes of Section 18 of the
Securities  Exchange Act of 1934 or otherwise subject to the liabilities of that
section,  nor shall it be deemed  incorporated  by reference in any filing under
the Securities Act of 1933 or the Securities  Exchange Act of 1934, whether made
before or after the date hereof and  irrespective  of any general  incorporation
language in any filings.

                                       16

<PAGE>

SIGNATURES

Pursuant  to the  requirements  of the  Securities  Exchange  Act of  1934,  the
Registrant  has duly  caused  this  report  to be  signed  on its  behalf by the
undersigned, thereunto duly authorized, on November 16, 2005.


                                       IR BIOSCIENCES HOLDINGS, INC.

                                       By: /s/ Michael Wilhelm
                                       ------------------------
                                       Michael Wilhelm
                                       President, Chief Executive Officer




                                       17