UNITED
STATES


SECURITIES AND EXCHANGE
COMMISSION


WASHINGTON,
D.C. 20549


FORM
10-K


(Mark
One)


[X]
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934For the fiscal year ended
December 31, 2009





[  ]
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934For the transition period
from        to





Commission
File Number 001-13835





APPLIED NEUROSOLUTIONS,
INC.


(Exact
name of registrant as specified in its charter)





Delaware
            39-1661164(State
      or other jurisdiction of incorporation or organization)
            (I.R.S.
      Employer Identification No.)





50 Lakeview Parkway, Suite
111,                                                      Vernon Hills,
IL  60061


(Address
of principal executive offices and zip code)





(847)
573-8000


(Registrant’s
telephone number, including area code)





Securities
registered pursuant to Section 12 (b) of the
Act:   None





Securities
registered pursuant to Section 12 (g) of the Act:





Common
Stock, $0.0025 par value


(Title of
class)





Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities
Act.    Yes   [   ]No [X]





Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the
Act.    Yes   [   ]No [X]





Indicate
by check mark whether the 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 12 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
      [   ]





Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K (section 229.405 of this chapter) is not contained herein, and
will not be contained, to the best of registrant’s knowledge, in definitive
proxy or information statements incorporated by reference in Part III of this
Form 10-K or any amendment to this Form 10-K.[X]





Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer or a smaller reporting
company.  See the definitions of “large accelerated filer,”
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act.





Large accelerated
filer                                         [   ]                                Accelerated
filer                                                           [   ]


Non-accelerated
filer                                           [   ]                                Smaller
reporting
company                                         [X]








Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).


Yes   [   ]
            No
      [X]





As of
June 30, 2009, the aggregate market value of voting common stock held by
non-affiliates of the Registrant (3,538,552 shares) was approximately
$2,653,914.  The aggregate market value was computed by reference to
the last sale price of such common equity as of that date.





As of
March 5, 2010, the issuer had 4,404,375 shares of Common Stock
outstanding.





Documents
Incorporated by
Reference:                                                                None











INDEX





PagePART
      IItem
      1.
            Business
            1Item
      1A.
            Risk
      factors
            8Item
      2.
            Properties
            17Item
      3.
            Legal
      proceedings
            17Item
      4.
            Submission
      of matters to a vote of security holders
            17PART
      IIItem
      5.
            Market
      for registrant’s common equity, related stockholder matters and issuer
      purchases of equity securities
            18Item
      6.
            Selected
      financial data
            18Item
      7.
            Management’s
      discussion and analysis of financial condition and results
      of  operations
            19Item
      7A.
            Quantitative
      and qualitative disclosures about market risk
            27Item
      8.
            Financial
      statements and supplementary data
            28Item
      9.
            Changes
      in and disagreements with accountants on accounting and financial
      disclosure
            56Item
      9A.
            Controls
      and procedures
            56Item
      9B.
            Other
      information
            57PART
      IIIItem
      10.
            Directors,
      executive officers and corporate governance
            57Item
      11.
            Executive
      compensation
            61Item
      12.
            Security
      ownership of certain beneficial owners and management and related
      stockholder matters
            64Item
      13.
            Certain
      relationships and related transactions, and director
      independence
            66Item
      14.
            Principal
      accounting fees and services
            66PART
      IVItem
      15.
            Exhibits,
      financial statement schedules
            67SIGNATURES
            
            72CERTIFICATIONS
            
            73








PART
I





This Form 10-K contains forward-looking
statements.  For this purpose, any statements contained in this Form
10-K that are not statements of historical fact may be deemed to be
forward-looking statements.  You can identify forward-looking
statements by those that are not historical in nature, particularly those that
use terminology such as “may,” “will,” “should,” “could,” “expects,”
“anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,”
“predicts,” “potential,” or “continue” or the negative of these similar
terms.  In evaluating these forward-looking statements, you should
consider various factors, including those listed below under the heading “Item
1A.  Risk factors”.  The Company’s actual results may differ
significantly from the results projected in the forward-looking
statements.  The Company assumes no obligation to update
forward-looking statements.





As used in this Form 10-K, references
to “APNS,” the “Company,” the “Registrant,” “we,” “our,” or “us” refer to
Applied NeuroSolutions, Inc. unless the context otherwise
indicates.





ITEM
1.                      BUSINESS





Applied NeuroSolutions, Inc. (“APNS” or
“the Company” or “we”) is a development stage biotechnology company focused on
the development of products for the early diagnosis and treatment of Alzheimer's
disease (“AD” or “Alzheimer’s”).





Alzheimer’s
Disease


Alzheimer’s disease is the most common
cause of dementia among people age 65 and older.  Dementia is the loss
of memory, reason, judgment and language to such an extent that it interferes
with a person’s daily life and activities.  Currently it is estimated
that over five million people in the U.S., and almost 35 million worldwide, have
Alzheimer’s disease and the national cost of caring for people with Alzheimer’s
is estimated to exceed $148 billion annually.  By 2050, it is
estimated that 16 million people in the U.S. will have Alzheimer’s, and the
global prevalence of Alzheimer’s is expected to be greater than 115 million
(Source:  Alzheimer’s Association and Alzheimer’s Disease
International).





Diagnostic
Programs


We are focused on developing
serum-based tests to detect AD at an early stage in the disease
process.  In July 2009 we announced we had achieved feasibility in our
development of a serum-based test related to the diagnosis of patients with AD
and provided an update in October 2009.  The results of two limited
studies achieved sufficient analytical sensitivity to detect tau in serum
patient samples.  The protein tau is directly linked to the pathology
of Alzheimer’s disease.  This is a key step in the development of a
blood-based test to detect AD.  Based on a further analysis of the
preliminary data, we believe additional development of the assay, including
optimization and validation in key patient population groups, is necessary to
determine the specific sensitivity and specificity performance of the
assay.  Our focus is on advancing the development of a blood-based
test for AD to commercialization in 2011 through reference labs under the
Clinical Laboratory Improvement Amendment of 1988 (“CLIA”).  Clinical
laboratories regulated under the CLIA, qualified to perform high complexity
testing, can provide physicians with test results utilizing in-house diagnostic
tests using Analyte specific reagents (“ASR's”), restricted devices under
section 520(e) of the Federal Food, Drugs, and Cosmetic Act.  We plan
to provide our reference laboratory partner with our proprietary ASR’s and
materials.  A serum-based test could be used not only as an aide to
early diagnosis of AD, but also as part of a routine annual physical to rule out
Alzheimer’s disease.  Our key milestones in the development of a
serum-based test and the estimated timeframe for achieving each milestone are
listed below:





Serum-Based Diagnostic Key
Milestones





FeasibilityCompleted


OptimizationMid 2010


Validation2nd half
2010


Reference Lab
Partnership1st half
2011


U.S.
Commercialization2nd half
2011











We have developed a cerebrospinal fluid
(“CSF”)-based test that can detect AD at an early stage as well as identify
patients with mild cognitive impairment (“MCI”) who are most likely to progress
to AD.  In a research setting, our CSF-based test, which detects a
certain AD associated protein found in the CSF of AD patients (“P-Tau 231”), has
demonstrated an ability to differentiate AD patients from those with other
diseases that have similar symptoms. This test is based on extensive testing in
the APNS lab, utilizing in excess of 2,500 CSF samples to differentiate patients
diagnosed with AD from patients diagnosed with other forms of dementia and
relevant neurological diseases, including major depression, as well as
age-matched healthy controls.  The CSF-based P-Tau 231 test has
demonstrated, based on published research validation studies, overall
sensitivity and specificity in the range of 85% to 95%, with sensitivity defined
as the percentage of true positives and specificity defined as the percentage of
true negatives.





Therapeutic Program -
Collaboration with Eli Lilly and Company


In November 2006, we entered into a
collaboration agreement with Eli Lilly and Company (“Lilly”).  APNS
and Lilly are engaged in the discovery and development of novel therapeutics for
the development of treatments for Alzheimer’s disease based upon an approach
developed by Dr. Peter Davies, our founding scientist.  As a result of
Dr. Davies’ research, APNS and Lilly are focused on discovery of unique
therapeutics that may be involved in a common intracellular phosphorylation
pathway leading to the development of the abnormal, destructive brain
structures, amyloid plaques and neurofibrillary tangles, that are characteristic
of Alzheimer’s disease.  APNS has identified various biomarkers that
we believe will aid in the development of diagnostics and drug specific
diagnostic markers that could also play a role in the development of new AD
treatments.





Lilly will, based on the achievement of
certain defined milestones, provide us over time with up to a total sum of $20
million in milestone payments for advancing the APNS proprietary target to a
therapeutic compound.  The collaboration has also made progress on
other targets that are part of the collaboration that could provide additional
milestone payments to us over time of up to a total sum of $10 million for
advancing each of these other targets to a therapeutic
compound.  Royalties are to be paid to us for AD drug compounds
brought to market that result from the collaboration.  Lilly will fund
the vast majority of all pre-clinical research and development and will fully
finance the clinical testing, manufacturing, sales and marketing of AD
therapeutics developed from this collaboration.





The collaboration has achieved
significant internal milestones to date.  The next milestone, which if
reached would result in our receipt of a cash payment from Lilly, is currently
expected in 2010.  Lilly remains fully committed to the collaboration
with resources focused on program progress and milestone
achievement.  The collaboration continues to make progress with
additional tau-based targets with various screens established and studies
underway.





In
November 2009, we agreed to a one-year renewal of our drug discovery
collaboration with Lilly.  We received $250,000 in December from Lilly
for this renewal.  In December 2009, we reached agreement with Lilly
to increase the scope of our drug discovery collaboration.  In
addition to the financial terms from the original collaboration agreement with
Lilly announced in 2006, we received a cash payment of $750,000 upon signing the
agreement in December and may receive up to $25.5 million based on achievement
of identified milestones.  Royalties would be paid to us for any AD
therapies brought to market that result from this addition to the original
collaboration agreement.





Our key milestones in our collaboration
with Lilly, and the current estimated timeframe for achieving each milestone are
listed below:





Collaboration with Lilly Key
Milestones





Target # 1Expected Completion
Date


Lead Declaration2010


Candidate
Selection2012


IND filing2013





Additional Targets


Portfolio Entry2010











Research Products and
Services


We market a transgenic mouse containing
the human tau gene that develops human paired helical filaments, the building
blocks of the neurofibrillary tangles, which are known to be involved in the
pathology of Alzheimer’s disease.  The pathology in these mice is
Alzheimer-like, with hyperphosphorylated tau accumulating in cell bodies and
dendrites as neurofibrillary tangles.  In addition, these transgenic mice
have exhibited extensive neuronal death that accompanies the tau
pathology.  These transgenic mice could be used for testing the efficacy of
therapeutic compounds.  To date, no widely accepted animal model that
exhibits both AD pathologies has been developed.  The mice are currently
available through Jackson Laboratories.





We also provide diagnostic services to
pharmaceutical companies.  Since 2003 we have analyzed approximately
1,500 clinical trial samples with our CSF phosphotau diagnostic assay and have
generated approximately $650,000 in revenue.





Alzheimer's
Disease Background





The market for Alzheimer’s Disease
therapy is expected to grow, based on the aging demographic of the seven major
pharmaceutical markets (USA, France, Germany, Italy, Spain, U.K. and
Japan).  Currently there are only five drugs approved in the U.S. to
treat AD.  Four are primarily acetylcholinesterase inhibitors; and one
is an NMDA receptor antagonist.  All are only beneficial in treating
symptoms associated with AD in a minority of AD patients for a very limited time
period.





Alzheimer’s disease is an intractable,
chronic and progressively incapacitating disease characterized by the
degeneration and death of several types of neurons in certain regions of the
brain.  Patients affected by the disease initially suffer loss of
memory, then a decline of intellectual abilities severe enough to interfere with
work and activities of daily living, followed by severe dementia and, finally,
death.  This illness, currently estimated to affect over five million
people in the United States, and almost 35 million people worldwide, is a
leading cause of death behind cardiovascular disease and
cancer.  While the disease is most common in the elderly, affecting
nearly 10% of people age 65 and older and up to 50% of people age 85 and older,
it has been diagnosed in patients in their 40’s and 50’s.  Alzheimer’s
disease, at present, can be conclusively diagnosed only by histological
examination of the brain by biopsy or autopsy.  The diagnosis of
patients suspected of having AD is therefore typically made through a process of
elimination, by conducting neurological and psychiatric examinations, extensive
laboratory tests and brain imaging to rule out other conditions (such as stroke,
brain tumor, or depression) that may exhibit similar symptoms.





Alzheimer’s disease was first described
in 1907 by Dr. Alois Alzheimer, a German psychiatrist who discovered large
numbers of unusual microscopic deposits in the brain of a demented patient upon
autopsy.  These deposits, called amyloid plaques and neurofibrillary
tangles, are highly insoluble protein aggregates that form in the brains of AD
patients in particular regions, including those involved with memory and
cognition.  Generally, amyloid plaques are deposited on the surface of
neurons, whereas neurofibrillary tangles are formed within
neurons.  The plaques and tangles are associated with degeneration and
loss of neurons.  The actual loss of neurons, as well as the impaired
function of surviving neurons, is generally believed to be the key
neuropathological contributors to the memory loss and dementia that
characterizes Alzheimer’s disease.





Sales
and Marketing





We currently plan to utilize
arrangements with corporate partners or other entities for the marketing and
sale of our proposed products.  Under our agreement with Eli Lilly and
Company, Lilly has an exclusive worldwide license to market and sell any AD
therapeutic, if any, that comes to market from our collaboration
agreement.  We do not currently have any agreements with partners or
other entities to provide sales and marketing services for our proposed
diagnostic products, but would seek those arrangements at the appropriate
time.





Manufacturing





We plan to rely upon third-party
manufacturers to manufacture our proposed products in accordance with these
regulations, or we will most likely utilize the capabilities of our partners
and/or collaborators.  Under our





agreement
with Eli Lilly and Company, Lilly has an exclusive worldwide license to
manufacture any therapeutic for AD that comes to market from our collaboration
agreement.





Competition





Companies in the pharmaceutical,
diagnostic and biotechnology fields are subject to intense
competition.  We compete with numerous larger companies that have
substantially greater financial and other resources and more
experience.  The principal factors affecting our competitive markets
include scientific and technological factors, the availability of patent and
other protection for technology and products, the ability, length of time and
cost required to obtain governmental approval for testing, manufacturing and
marketing and physician acceptance.  Companies that complete clinical
trials, obtain regulatory approvals and commence commercial sales of their
products before us may achieve a significant competitive
advantage.  In addition, such companies may succeed in developing
products that are more effective and less costly than products that may be
developed by us.  There can be no assurance that developments by other
companies will not render our products or technologies obsolete or
noncompetitive or that we will be able to keep pace with the technological
developments of our competitors.





We believe that some of our competitors
are in the process of developing technologies that are, or in the future may be,
the basis for competitive products.  Some of these products may have
an entirely different approach or means of accomplishing the desired therapeutic
or diagnostic effect than products being developed by us.  These
competing products may be more effective and less costly than the products
developed by us.





Significant levels of research within
our fields of interest occur at universities, non-profit institutions, and
for-profit organizations.  These entities compete with us in
recruiting skilled scientific talent.





We believe that our ability to compete
successfully will depend upon our ability to create and maintain scientifically
advanced technology, obtain adequate funding, develop proprietary products,
attract and retain scientific personnel, obtain patent or other protection for
our products, develop strategic alliances to enhance the likelihood of success,
obtain required regulatory approvals and manufacture and successfully market our
products either directly by us or through our collaboration with Eli Lilly and
Company and other collaborations or partnerships we may enter into.





Diagnostics





There is currently no FDA-approved
diagnostic to detect Alzheimer's disease ("AD"), although there are tests
available under the CLIA exemption through reference labs.  If any of
our current diagnostic programs are ultimately successfully marketed, they would
compete against, or augment, the most widely used current practice of detecting
AD through a battery of tests, namely neurological and psychiatric examinations,
extensive laboratory tests and brain imaging to rule out other conditions (such
as stroke, brain tumor, or depression) with similar symptoms.  The AD
predictive accuracy of such a battery of exams is generally in the range of
80%-90% in some of the larger AD centers, but is usually closer to 60% when
diagnosed outside of the AD centers.  Costs to patients for such
testing can range from $1,000 - $4,000, including imaging
procedures.  A simple, predictive, accurate and cost effective
diagnostic test could, therefore, be an attractive alternative for medical
practitioners and insurers to the current practice to detect AD.  If
the test was a serum-based test it could potentially be utilized as a routine
screening test.





We are aware of other companies and
academic institutions pursuing the development of biochemical markers to be
utilized in the diagnosis of AD.  Potential competitors include Nymox
Pharmaceutical Corp. and Innogenetics, who have developed diagnostic tests for
AD.  Athena Diagnostics has “research use only” type CSF-based tests
available, and others (Satoris, Power 3 Medical, OPKO Health, ExonHit
Therapeutics, Diagenic and Acumen Pharmaceuticals) have programs directed toward
identifying proteomic or genetic markers for AD.  Competitive
diagnostics in development, as well as some that are marketed through reference
laboratories, include approaches which attempt to identify AD patients by
measuring: (i) normal tau, total tau or phosphorylated tau in CSF, either
individually, or as part of a panel, (ii) beta amyloid, (iii) neural thread
protein in CSF and/or urine, (iv) amyloid derived diffusible ligands (“ADDL’s”)
in CSF, (v) imaging plaques in the brain, or (vi) employing proteomic or genetic
markers for AD.  Much of our knowledge of potential competitors and
their diagnostic tests comes from our review of published articles in scientific
journals.  Publications and other information publicly available
indicate that tests being developed by these companies and others are unable to
adequately distinguish AD





from
other brain disorders or are in too early a development stage to be
evaluated.  At this time, we believe our CSF-based diagnostic test
exhibits a unique ability to recognize early stage AD and to differentiate
patients diagnosed with AD from patients diagnosed with other forms of dementia
and relevant neurological diseases, including major depression, as well as
healthy controls.  In addition, our CSF-based diagnostic test has
shown to be a strong predictor of the decline from MCI to AD.





Therapeutics





The only products with FDA approved
label claims for pharmaceutical management of AD in the U.S. provide symptomatic
treatment through the use of acetylcholinesterase (“AchE”) inhibitors, of which
there are four: Aricept/donepezil (Pfizer and Esai), Exelon/rivastigmine
(Novartis), Razadyne/galantamine (Johnson & Johnson), and Cognex/tacrine
(Pfizer); or through the use of NMDA antagonists, of which there is
one:  Namenda/memantine (Forest Labs).  Despite limited
clinical effectiveness and a poor safety and side effect profile, sales of these
drugs in 2008 exceeded  $6.0 billion, according to BioPharm
Reports.





The market for AD therapy is expected
to grow, based on the aging demographic of the seven major pharmaceutical
markets (USA, France, Germany, Italy, Spain, U.K. and Japan).  AchE
inhibitors remain the largest class of drugs within the late stage development
pipeline.  However, their apparent limited efficacy would seem to
provide an opportunity for other promising compounds.  It is estimated
that over 100 potential compounds are currently being developed by both major
pharmaceutical companies as well as small biotech companies.  The lack
of current effective pharmacological therapy for an increasing AD population
provides an attractive opportunity for therapeutics we may discover utilizing
our novel therapeutic approach in our collaboration with Eli Lilly and
Company.





Patents,
licenses, trade secrets and proprietary rights





Our success depends and will continue
to depend, in part, upon our ability to retain our exclusive licenses, to
maintain patent protection for our products and processes, to preserve our trade
secrets and proprietary information and to operate without infringing the
proprietary rights of third parties.  We believe in securing and
supporting a strong competitive position through the filing and prosecution of
patents where available, and through trade secrets, when patenting is
precluded.





We have filed patent applications in
the U.S. for composition of matter and use of compounds to treat AD, method of
use, as well as aspects of our diagnostic test technologies for use in MCI and
methods for developing novel therapeutic screens for the discovery of compounds
useful in the treatment of AD, novel approaches to therapeutic intervention,
transgenic mouse production and a novel gene.  Patent Cooperation
Treaty (“P.C.T.”) applications have been filed abroad, when
applicable.








Alzheimer's
disease technology license





We have various License and
Collaborative Research Agreements (the "Agreements") with Albert Einstein
College of Medicine ("AECOM").  These Agreements grant us the
exclusive rights to neurodegenerative disease technology, primarily Alzheimer's
disease technology for diagnostic and therapeutic applications from Dr. Peter
Davies’ lab at AECOM.  These Agreements were amended in March 2002, in
September 2002, in October 2006, in December 2008, and in November 2009 and
remain effective on an evergreen basis.  The minimum annual payments
to be made to AECOM, which consist of payments due for support of research
conducted in Dr. Davies' lab and for annual license maintenance, are as
follows:





Year
            
            Amount2010
      and each subsequent year
            
            $500,000





As part of the December 2008 amendment,
AECOM agreed to defer the 2009 semi-annual maintenance payments until the
earlier of December 31, 2009 or a fund raise at least equal to $3,500,000. In
exchange for this deferral, we agreed to prepay the quarterly funding payments
that are due in February 2009, May 2009 and August 2009.  This
prepayment of $112,500 was made in December 2008.  As part of the
November 2009 amendment,





AECOM
agreed to further defer the 2009 semi-annual maintenance payments and the 2010
semi-annual maintenance payments until the earlier of (i) December 31, 2010 or
(ii) a fund raise at least equal to $4,000,000.  AECOM also agreed to
defer the November 2009 quarterly research support payment until February
2010.  We are currently in discussions with AECOM on the timing of a
payment for AECOM’s percentage of the $750,000 we received from Eli Lilly and
Company in December 2009.  We are obligated to continue to pay AECOM
$500,000 for each year after 2010 in which the Agreements are still in
effect.  In addition, we are obligated to pay AECOM a percentage of
all revenues we receive from selling and/or licensing aspects of the AD
technology licensed under the Agreements that exceeds the minimum obligations
reflected in the annual license maintenance payments.





Confidentiality
and assignment of inventions agreements





We require our employees, consultants
and advisors having access to our confidential information to execute
confidentiality agreements upon commencement of their employment or consulting
relationships with us.  These agreements generally provide that all
confidential information we develop or make known to the individual during the
course of the individual's employment or consulting relationship with us must be
kept confidential by the individual and not disclosed to any third
parties.  We also require all of our employees and consultants who
perform research and development for us to execute agreements that generally
provide that all inventions conceived by these individuals will be our
property.





Government
regulation





The research, development, manufacture,
and marketing of our potential products are subject to substantial regulation by
the U.S. Food and Drug Administration (“FDA”) in the United States and by
comparable authorities in other countries.  These national agencies
and other federal, state, and local entities regulate, among other things,
research and development activities and the testing, manufacture, safety,
effectiveness, labeling, storage, record keeping, approval, advertising, and
promotion of our potential products.





Diagnostics





We plan to market our serum and CSF in
vitro diagnostic products in the United States without FDA approval under the
Clinical Laboratory Improvement Amendment (“CLIA”) of 1988.  Clinical
laboratories regulated under the CLIA, qualified to perform high complexity
testing, can provide physicians with test results utilizing in-house diagnostic
tests using Analyte specific reagents (“ASR's”), restricted devices under
section 520(e) of the Federal Food, Drugs, and Cosmetic Act.  We plan
to provide our reference laboratory partner with our proprietary ASR’s and
materials.  The reference laboratory(ies) performing the tests are
required to inform the ordering person of the diagnostic test result that, “This
test was developed and its performance characteristics determined by (Laboratory
Name). It has not been cleared or approved by the U.S. Food and Drug
Administration."





In the
future we may seek FDA approval, utilizing the Premarket Approval Application
(“PMA”) process regulated by the Office of In Vitro Diagnostic Device and Safety
(“OIVD”) of the FDA.  The regulatory process leading to a submission
of an in vitro diagnostic device PMA for FDA approval to market involves a
multistage process including: (1) a Pre-Investigational Device Exemption
(“Pre-IDE”) program in which preliminary information is submitted to the FDA for
review and guidance on, and acceptance of, the test protocol and proposed
clinical trial to evaluate the safety and effectiveness of an in vitro
diagnostic product followed by, (2) an Investigational Device Exemption (“IDE”)
submission for approval to allow the investigational diagnostic device to be
used in a clinical study in order to (3) collect safety and effectiveness data
required to support a PMA to receive FDA approval to market a
device.  Data from a clinical trial is used to evaluate the clinical
performance of the diagnostic test.





Regulatory authorities in foreign
countries must grant approval prior to the commencement of commercial sales of
the product in such countries.   We may seek regulatory approval
in Europe, most likely in collaboration with a partner.





Therapeutics





As an initial step in the FDA
regulatory approval process for a prospective therapeutic product, preclinical
studies are typically conducted in animals to identify potential safety
problems.  For certain diseases, animal models





may
exist which are believed to be predictive of human efficacy.  For
these diseases, a drug candidate is tested in an animal model.  The
results of the studies are submitted to the FDA as a part of an Investigational
New Drug Application (“IND”), which is filed to comply with FDA regulations
prior to beginning human clinical testing.





Clinical trials for new therapeutics
are typically conducted in three sequential phases, although the phases may
overlap.  In Phase I, the compound is tested in healthy human subjects
for safety (adverse effects), dosage tolerance, absorption, biodistribution,
metabolism, excretion, clinical pharmacology and, if possible, to gain early
information on effectiveness.  Phase II typically involves studies in
a small sample of the intended patient population to assess the efficacy of the
drug for a specific indication, to determine dose tolerance and the optimal dose
range, and to gather additional information relating to safety and potential
adverse effects.  Phase III trials are comparative clinical studies
undertaken to further evaluate clinical safety and efficacy in an expanded
patient population at geographically dispersed study sites in order to determine
the overall risk-benefit ratio of the drug and to provide an adequate basis for
physician labeling.  Each trial is conducted in accordance with
certain standards under protocols that detail the objectives of the study, the
parameters to be used to monitor safety and efficacy criteria to be
evaluated.  Each protocol must be submitted to the FDA as part of the
IND.  Further, each clinical study must be evaluated by an independent
Institutional Review Board (“IRB”) at the institution at which the study will be
conducted.  The IRB will consider, among other things, ethical
factors, the safety of human subjects and the possible liability of the
institution.





Data from preclinical testing and
clinical trials are submitted to the FDA in a New Drug Application (“NDA”) for
marketing approval.  Preparing an NDA involves considerable data
collection, verification, analysis and expense, and there can be no assurance
that any approval will be granted on a timely basis, if at all.  The
approval process is affected by a number of factors, including the severity of
the disease, the availability of alternative treatments and the risks and
benefits demonstrated in clinical trials.  The FDA may deny an NDA if
applicable regulatory criteria are not satisfied or require additional testing
or information.  Among the conditions for marketing approval is the
requirement that the prospective manufacturer's quality control and
manufacturing procedures conform to the FDA's good manufacturing practices
(“GMP”) regulations, which must be followed at all times.  In
complying with standards set forth in these regulations, manufacturers must
continue to expend time, monies and effort in the area of production and quality
control to ensure full technical compliance.  Manufacturing
establishments serving the U.S. markets, both foreign and domestic, are subject
to inspections by, or under the authority of, the FDA and by other federal,
state or local agencies.





The process of completing clinical
testing and obtaining FDA approval for a new drug is likely to take a number of
years from the commencement of the clinical trial and require the expenditure of
substantial resources.  We would require significant additional funds
in the future to finance the clinical testing process if we developed any
therapeutic products on our own.  Under our agreement with Eli Lilly
and Company, however, Lilly will finance the clinical testing process of any AD
therapeutic developed from our collaboration.





Environmental
regulation





In connection with our research and
development activities, our business is, and will in the future continue to be,
subject to regulation under various state and federal environmental
laws.  These laws and regulations govern our use, handling and
disposal of various biological and chemical substances used in our
operations.  Although we believe that we have complied with these laws
and regulations in all material respects and we have not been required to take
any action to correct any noncompliance, there can be no assurance that we will
not be required to incur significant costs of complying with health and safety
regulations in the future.





Employees





As of March 5, 2010 we had three
full-time employees, two of whom have advanced scientific
degrees.  None of our employees are covered by a collective bargaining
agreement and we believe all relations with our employees are
satisfactory.  In addition, to complement our internal expertise, we
have license agreements with AECOM that provide access to Dr. Peter Davies and
the academic researchers in his lab and we may contract with other academic
research laboratories, outside organizations with specific expertise and
scientific consultants that provide pertinent expertise with therapeutic and
diagnostic development.  In the future, we may hire additional
research, development and other personnel in addition to utilizing outside
organizations and consultants.











History





On September 10, 2002, Hemoxymed, Inc.
and Molecular Geriatrics Corporation (“MGC”) established a strategic alliance
through the closing of a merger (the “Merger”).  The Merger agreement
provided that the management team and Board of Directors of MGC took over
control of the merged company.  The transaction was tax-free to the
shareholders of both companies.  In October 2003, we changed our name
to Applied NeuroSolutions, Inc.  The Merger transaction has been
accounted for as a reverse merger.  For financial reporting purposes,
MGC (now “APNS”) is continuing as the primary operating entity under the
Company’s name, and its historical financial statements have replaced those of
the Company.  Thus, all financial information prior to the Merger date
is the financial information of MGC only.





After the Merger, we had two
wholly-owned operating subsidiaries, which were dissolved during
2004.  The assets of these dissolved subsidiaries were transferred to
us.





One of the wholly-owned operating
subsidiaries we dissolved was MGC, a development stage biopharmaceutical company
incorporated in November 1991, with operations commencing in March 1992, to
develop diagnostics to detect AD, and therapeutic targets directed at AD
solutions.





The other wholly-owned operating
subsidiary we dissolved was Hemoxymed Europe, SAS, a development stage
biopharmaceutical company incorporated in February 1995 to develop therapies
aimed at improving tissue oxygenation by increasing oxygen release from
hemoglobin to provide therapeutic value to patients with
serious,  medical needs.  We are not currently funding the
development of this technology.





ITEM
1A.                      RISK
FACTORS





Factors that could cause or contribute
to differences in our actual results include those discussed in the following
section, as well as those discussed in other parts of this Annual Report on Form
10-K.  You should consider carefully the following risk factors,
together with all of the other information included in this Annual Report on
Form 10-K.  Each of these risk factors could adversely affect our
business, operating results and financial condition, as well as adversely affect
the value of our common stock.





Our
cash balances as of December 31, 2009 should be sufficient to fund our current
planned development activities into the second quarter of 2010.  We
will need to raise funds in the second quarter of 2010 in order to continue
operations and we may have difficulty raising capital.





As of December 31, 2009, we had cash of
$794,003.  The cash on hand will be used for ongoing research and
development, working capital, general corporate purposes and possibly to secure
appropriate partnerships and expertise.  Since we do not expect to
generate significant revenues from operations in 2010, we will be required to
raise additional capital in financing transactions or through some form of
collaborative partnership in order to satisfy our expected cash expenditures
after the second quarter of 2010.  On March 10, 2010, we entered into
a Securities Purchase Agreement (the “Agreement”), with an outside investor,
providing for the issuance of an 8% Secured Convertible Note, due December 10,
2010, in the principal amount of $100,000 (the “Note”).  The Note is
convertible at any time prior to maturity into shares of our common stock at a
variable conversion price generally equal to 62.5% of the average of the daily
dollar volume-weighted average sale price of our common stock over the ten
consecutive trading days immediately preceding the date on which the conversion
price is determined.  We expect to raise additional capital by selling
shares of our capital stock, proceeds from exercises of existing warrants and/or
stock options and/or by borrowing money.  However, such additional
capital may not be available to us at acceptable terms or at all.  As
of March 5, 2010, we have approximately 94,700,000 authorized shares of common
stock available for issuance, which are sufficient available authorized shares
of common stock to issue in a funding and for other uses as deemed appropriate
by our Board of Directors.  Further, if we sell additional shares of
our capital stock, current ownership positions in our Company will be subject to
dilution. In the event that we are unable to obtain additional capital, we may
be forced to further reduce key operating expenditures or to cease operations
altogether.








Our
financial statements have been prepared assuming that we would continue as a
going concern.  We have had recurring net losses, including net losses
for each of the years ended December 31, 2009 and 2008, and have an accumulated
deficit of approximately $51.4 million as of December 31, 2009.  In
the view of our independent registered public accountants, these conditions
raise substantial doubt about our ability to continue as a going
concern.  We anticipate that our cash balances at December 31, 2009,
should be sufficient to fund our current level of operations into the second
quarter of 2010.  We will need additional funding in the second
quarter of 2010 in order to continue our research, product development and
operations.  If we are successful in achieving key milestones for our
serum-based diagnostic test for AD, we believe we could begin generating revenue
from our serum diagnostic program in mid 2011 under the Clinical Laboratory
Improvement Amendment of 1988 (“CLIA”). Clinical laboratories regulated under
the CLIA, qualified to perform high complexity testing, can provide physicians
with test results utilizing in-house diagnostic tests using Analyte specific
reagents (“ASR's”), restricted devices under section 520(e) of the Federal Food,
Drugs, and Cosmetic Act.  We plan to provide our reference laboratory
partner with our proprietary ASR’s and materials.  The reference
laboratory(ies) performing the tests are required to inform the ordering person
of the diagnostic test result that, “This test was developed and its performance
characteristics determined by (Laboratory Name).  It has not been
cleared or approved by the U.S. Food and Drug Administration."  In
order to sell our serum-based diagnostic test under CLIA, we would need to
contract or partner with a CLIA certified lab.





If we are
unable to raise additional capital, we may be forced to discontinue our
business.





We
are a development stage company without any products currently being validated
under CLIA regulations or in FDA clinical trials.





We are a development stage
company.  Our product furthest along is a diagnostic test which
detects Alzheimer’s disease utilizing cerebrospinal fluid
(“CSF”).  Our serum diagnostic is in development, with product revenue
expected in the second half of 2011.  Our therapeutic products are in
pre-clinical development, and product revenues may not be realized from the sale
of any such products for several years, if at all.  Our proposed
products will require significant additional research and development efforts
prior to any commercial use.  There can be no assurances that our
research and development efforts will be successful, that our potential products
will prove to be safe and effective in clinical trials or that we will develop
any commercially successful products.  We currently have no approved
products on the market and have not received any commercial revenues from the
sale or license of any FDA approved diagnostic or therapeutic
products.





We
have a history of operating losses and expect to sustain losses in the
future.





We have experienced significant
operating losses since our inception.  As of December 31, 2009, we had
an accumulated deficit of approximately $51.4 million.  We expect to
incur operating losses over the next few years as our research and development
and commercialization efforts continue.  Our ability to achieve
profitability depends in part upon our ability, alone or with or through others,
to raise additional capital to execute our business plan, to advance development
of our proposed products, to obtain required regulatory approvals, to
manufacture and market our products, and to successfully commercialize our
approved products.





We
face extensive governmental regulation and any failure to comply could prevent
or delay product approval or cause the disallowance of our products after
approval.





The U.S. Food and Drug Administration,
and comparable agencies in foreign countries, impose many requirements on the
introduction of new therapeutics through lengthy and detailed clinical testing
procedures, and other costly and time consuming compliance procedures relating
to the manufacture, distribution, advertising, pricing and marketing of
pharmaceutical products.  These requirements make it difficult to
estimate when any of our products in development will be available commercially,
if at all.





The regulatory process takes many years
and requires the expenditure of substantial resources.  Clinical
trials for diagnostic products, including the FDA submission and approval
process, generally take less time than for therapeutic products.  Data
obtained from pre-clinical and clinical activities are subject to varying
interpretations that could delay, limit or prevent regulatory agency approval.
We may also encounter delays or rejections based on changes in regulatory agency
policies during the period in which we develop our products and/or the period
required





for
review of any application for regulatory agency approval of a particular
product. Delays in obtaining regulatory agency approvals will make the projects
more costly and adversely affect our business.





We plan to market our serum and CSF
in-vitro diagnostic products in the United States without FDA approval under the
Clinical Laboratory Improvement Amendment (“CLIA”) of 1988.  Clinical
laboratories regulated under the CLIA, qualified to perform high complexity
testing, can provide physicians with test results utilizing in-house diagnostic
tests using Analyte specific reagents (“ASR's”), restricted devices under
section 520(e) of the Federal Food, Drugs, and Cosmetic Act.  We plan
to provide our reference laboratory partner with our proprietary ASR’s and
materials.  The reference laboratory(ies) performing the tests are
required to inform the ordering person of the diagnostic test result that, “This
test was developed and its performance characteristics determined by (Laboratory
Name).  It has not been cleared or approved by the U.S. Food and Drug
Administration."





In the future, we may seek FDA
approval, utilizing the Premarket Approval Application (“PMA”) process regulated
by the Office of In Vitro Diagnostic Device and Safety (“OIVD”) of the
FDA.  The regulatory process leading to a submission of an in vitro
diagnostic device PMA for FDA approval to market involves a multistage process
including: (1) a Pre-Investigational Device Exemption (“Pre-IDE”) program in
which preliminary information is submitted to the FDA for review and guidance
on, and acceptance of, the test protocol and proposed clinical trial to evaluate
the safety and effectiveness of an in vitro diagnostic product followed by, (2)
an Investigational Device Exemption (“IDE”) submission for approval to allow the
investigational diagnostic device to be used in a clinical study in order to (3)
collect safety and effectiveness data required to support a PMA to receive FDA
approval to market a device.  Data from a clinical trial is used to
evaluate the clinical performance of the diagnostic test.





Even if we successfully enroll patients
in clinical trials for our diagnostic or therapeutic products, setbacks are a
common occurrence in clinical trials.  These setbacks often
include:





·
            Failure
      to comply with the regulations applicable to such testing may delay,
      suspend or cancel our clinical
trials,


·
            The
      FDA might not accept the test
results,


·
            The
      FDA, or any comparable regulatory agency in another country, may suspend
      clinical trials at any time if it concludes that the trials expose
      subjects participating in such trials to unacceptable health
      risks,


·
            Human
      clinical testing may not show any current or future product candidate to
      be safe and effective to the satisfaction of the FDA or comparable
      regulatory agencies, and


·
            The
      data derived from clinical trials may be unsuitable for submission to the
      FDA or other regulatory agencies.





In 2005 we filed with the FDA a
Pre-Investigational Device Exemption (“Pre-IDE”) application with respect to our
CSF-based diagnostic test and we had our Pre-IDE meeting with the FDA in
November 2005.    Subsequent to our meeting with the FDA, we
worked with our clinical consultants to refine our clinical
protocol.  At that time, work was suspended until such time that we,
along with our consultants, could identify a cost effective protocol that would
be acceptable to the FDA and offer the opportunity to obtain desired claims and
indications.  It is uncertain when we will file a Pre-IDE for any of
our diagnostic programs in development. We have not filed any Investigational
New Drug (“IND”) with respect to our AD therapeutic, and the timing of such
filing in the future is uncertain, and subject to the progress of our
collaboration with Eli Lilly and Company.  We cannot predict with
certainty when we might submit any of our proposed products currently under
development for regulatory review.  Once we submit a proposed product
for review, the FDA or other regulatory agencies may not issue their approvals
on a timely basis, if at all.  If we are delayed or fail to obtain
such approvals, our business may be adversely affected.   If the
FDA grants approval for a drug or device, such approval may limit the indicated
uses for which we may market the drug or device and this could limit the
potential market for such drug or device. Furthermore, if we obtain approval for
any of our products, the marketing and manufacture of such products remain
subject to extensive regulatory requirements. Even if the FDA grants approval,
such approval would be subject to continual review, and later discovery of
unknown problems could restrict the products future use or cause their
withdrawal from the market. If we fail to comply with regulatory requirements,
either prior to approval or in marketing our products after approval, we could
be subject to regulatory or judicial enforcement actions.  Failure to
comply with regulatory requirements could, among other things, result
in:








·
            product
      recalls or seizures,


·
            fines
      and penalties,


·
            injunctions,


·
            criminal
      prosecution,


·
            refusals
      to approve new products and withdrawal of existing approvals,
      and/or


·
            enhanced
      exposure to product liabilities.







In order to market our products outside
of the United States, we must comply with numerous and varying regulatory
requirements of other countries regarding safety and quality. The approval
procedures vary among countries and can involve additional product testing and
administrative review periods. The time required to obtain approval in other
countries might differ from that required to obtain FDA approval. The regulatory
approval process in other countries includes all of the risks associated with
obtaining FDA approval detailed above. Approval by the FDA does not ensure
approval by the regulatory authorities of other countries.





In addition, many countries require
regulatory agency approval of pricing and may also require approval for the
marketing in such countries of any drugs or devices we develop. We cannot be
certain that we will obtain any regulatory approvals in other countries and the
failure to obtain such approvals may materially adversely affect our
business.





Under our agreement with Eli Lilly and
Company, however, all aspects of our therapeutic collaboration will be largely
funded by Lilly.





Our
technologies are subject to licenses and termination of any of those licenses
would seriously harm our business.





We have exclusive licenses with Albert
Einstein College of Medicine ("AECOM") covering virtually all of our Alzheimer's
disease technology, including virtually all our AD related diagnostic and
therapeutic products currently in development.  We depend on these
licensing arrangements to maintain rights to our products under
development.  These agreements require us to make payments in order to
maintain our rights.  The agreements also generally require us to pay
royalties on the sale of products developed from the licensed technologies, fees
on revenues from sublicensees, where applicable, and the costs of filing and
prosecuting patent applications.  We are currently in discussions with
AECOM on the timing of a payment for AECOM’s percentage of the $750,000 we
received from Eli Lilly and Company in December 2009.  Our current
interpretation of the Agreements, as amended, is that we are currently in
compliance with our license agreements; however if the payment is now due, we
may be in default of the Agreements with AECOM if we are unable to make the
payment. Further, we will need to raise additional capital prior to December 31,
2010 in order to meet our ongoing obligations to AECOM.  If we fail to
raise sufficient funds, and consequently default on our obligations to AECOM,
our licenses could terminate, and we could lose the rights to our proprietary
technologies. Such a loss would have a material adverse effect on our operations
and prospects.





Our
collaboration agreement with Eli Lilly and Company may not provide the future
payments we anticipate over the course of the agreement, or may not provide the
future payments in a time frame consistent with our expectations, which could
result in the termination of our operations.





In November 2006, we entered into an
agreement with Eli Lilly and Company to develop therapeutics to treat
AD.  Lilly received the exclusive worldwide rights to the intellectual
property related to our expertise in understanding the molecular neuropathology
of AD as it pertains to the formation of neurofibrillary tangles.  In
December 2009, we entered into an agreement with Lilly to increase the scope of
our collaboration.  Lilly may not advance any of the technology under
the agreements as fast, or as far, as we would anticipate, if at all, to provide
us with the milestone and royalty payments we expected when we signed the
agreements.  In addition, Lilly may decide to allocate internal
resources to other projects and slow down, or stop the work, under our
collaboration agreements for a period of time, which could cause our technology
under the agreements not to be advanced at the rate we expected, or not be
advanced at all.  Such a situation could have a material adverse
effect on our operations and prospects and we may have to shut down, or scale
back, our operations unless we could enter into new partnership arrangements or
raise additional capital.








The
demand for diagnostic products for Alzheimer’s disease may be limited because
there is currently no cure or highly effective therapeutic products to treat the
disease.





Since there is currently no cure or
highly effective therapy that can stop the progression of Alzheimer’s disease,
the market acceptance and financial success of a diagnostic technology capable
of detecting Alzheimer’s disease may be limited.  As a result, even if
we successfully develop a safe and effective diagnostic technology for
identifying this disease, its commercial value might be limited.





The
value of our research could diminish if we cannot protect, enforce and maintain
our intellectual property rights adequately.





The pharmaceutical and diagnostic
industries place considerable importance on obtaining patent and trade secret
protection for new technologies, products and processes, and where possible, we
actively pursue both domestic and foreign patent protection for our proprietary
products and technologies. Our success will depend in part on our ability to
obtain and maintain patent protection for our technologies and to preserve our
trade secrets. When patent protection is available, it is our policy to file
patent applications in the United States and selected foreign jurisdictions. We
currently hold and maintain issued United States patents and various related
foreign patents.    No assurance can be given that our
issued patents will provide competitive advantages for our technologies or will
not be challenged or circumvented by competitors. With respect to already issued
patents, there can be no assurance that any patents issued to us will not be
challenged, invalidated, circumvented or that the patents will provide us
proprietary protection or a commercial advantage. We also rely on trade secrets
and proprietary know-how, which we seek to protect, in part, through
confidentiality agreements with employees, consultants, collaborative partners
and others. There can be no assurance that these agreements will not be
breached.





The ability to develop our technologies
and to commercialize products will depend on avoiding the infringement of
patents of others.  While we are aware of patents issued to
competitors, we are not aware of any claim of patent infringement against us,
except as described in the following two paragraphs.  Any potential
patent infringement may require us to acquire licensing rights to allow us to
continue the development and commercialization of our products.  Any
such future claims concerning us infringing patents and proprietary technologies
could have a material adverse effect on our business. In addition, litigation
may also be necessary to enforce any of our patents or to determine the scope
and validity of third-party proprietary rights.  There can be no
assurance that our patents would be held valid by a court of competent
jurisdiction.  We may have to file suit to protect our patents or to
defend use of our patents against infringement claims brought by
others.  Because we have limited cash resources, we may not be able to
afford to pursue or defend against litigation in order to protect our patent
rights.





In March 2004 we were notified by email
from Innogenetics, a Belgian biopharmaceutical company involved in specialty
diagnostics and therapeutic vaccines, that it believes the CSF diagnostic test
we have been developing uses technology that is encompassed by the claims of its
U.S. patents.    Innogenetics also informed us that it could
be amenable to entering into a licensing arrangement or other business deal with
us regarding our patents.  We had some discussions with Innogenetics
concerning a potential business relationship, however no further discussions
have been held since the second quarter of 2006.





We have reviewed these patents with our
patent counsel on several occasions prior to receipt of the email from
Innogenetics and subsequent to receipt of the email.  Based on these
reviews, we believe that our CSF diagnostic test does not infringe the claims of
these Innogenetics patents.    If we were unable to reach a
mutually agreeable arrangement with Innogenetics, we may be forced to litigate
the issue.  Expenses involved with litigation may be significant,
regardless of the ultimate outcome of any litigation.  An adverse
decision could prevent us from possibly marketing a future diagnostic product
and could have a material adverse impact on our business.





We also rely on trade secrets to
protect our proprietary technologies, especially where we do not believe patent
protection is appropriate or obtainable.  However, trade secrets can
be difficult to protect.  We rely in part on confidentiality
agreements with our employees, consultants, outside scientific collaborators,
sponsored researchers and others to protect our trade secrets and other
proprietary information.  These agreements may not effectively prevent
disclosure of confidential information and may not provide an adequate remedy if
unauthorized disclosure of confidential information occurs.  In
addition, others may independently discover our trade secrets and
proprietary





information.  Costly
and time-consuming litigation could be necessary to enforce and determine the
scope of our proprietary rights, and failure to obtain or maintain trade secret
protection could adversely affect our competitive position.  None of
our employees, consultants, scientific researchers or collaborators has any
rights to publish scientific data and information generated in the development
or commercialization of our products without our approval, with the exception of
Eli Lilly and Company’s rights under our collaboration
agreement.  Under the license agreements with us, AECOM has a right to
publish scientific results relating to the diagnosis of AD and precursor or
related conditions in scientific journals, provided, that AECOM must give us
pre-submission review of any such manuscript to determine if it contains any of
our confidential information or patentable materials.





We
face large competitors and our limited financial and research resources may
limit our ability to develop and market new products.





The biotechnology, diagnostic and
pharmaceutical markets generally involve rapidly changing technologies and
evolving industry standards.  Many companies, both public and private,
are developing products to diagnose and to treat Alzheimer’s
disease.  Most of these companies have substantially greater
financial, research and development, manufacturing and marketing experience and
resources than we do.  As a result, our competitors may more rapidly
develop effective diagnostic products as well as therapeutic products that are
more effective or less costly than any product that we may
develop.  Under our agreement with Eli Lilly and Company, however, all
aspects of our therapeutic collaboration will be largely funded by
Lilly.





We also face competition from
universities, governmental agencies and other public and private research
institutions.  These competitors are becoming more active in seeking
patent protection and licensing arrangements to collect royalties for use of
technology that they have developed.  Some of these technologies may
compete directly with the technologies being developed by us.  Also,
these institutions may also compete with us in recruiting highly qualified
scientific personnel.





We
do not have manufacturing capability and we must rely on third- party
manufacturers to produce our products, giving us limited control over the
quality of our products and the volume of products produced.





While we have internally manufactured
some of the reagents and materials necessary to conduct our activities related
to research and development of our diagnostic products, we do not currently have
any large scale manufacturing capability, expertise or personnel and expect to
rely on outside manufacturers to produce material that will meet applicable
standards for clinical testing of our products and for larger scale production
if marketing approval is obtained.





We will either find our own
manufacturing facilities, rely upon third-party manufacturers to manufacture our
proposed products in accordance with appropriate regulations, or we will most
likely utilize the capabilities of our partners and/or
collaborators.  Under our agreement with Eli Lilly and Company, Lilly
has an exclusive worldwide license to manufacture, market and sell any AD
therapeutic that comes to market from our collaboration agreements. We do not
have any outside manufacturing agreements for our proposed diagnostic
products.  If we, or Lilly, choose to utilize an outside manufacturer,
we cannot assure that any outside manufacturer that we, or Lilly, select will
perform suitably or will remain in the contract manufacturing business, in which
instances we (or Lilly) would need to find a replacement manufacturer or we
would have to develop our own manufacturing capabilities.  If we are
unable to do so, our ability to obtain regulatory approval for our products
could be delayed or impaired.  Our ability, and Lilly’s ability, to
market our products could also be affected by the failure of our third-party
manufacturers or suppliers to comply with the good manufacturing practices
required by the FDA and foreign regulatory authorities.





We
do not have marketing and sales staff to sell our products and we must rely on
third parties to sell and market our products, the cost of which may make our
products less profitable for us.





We do not have marketing and sales
experience or personnel.  As we currently do not intend to develop a
marketing and sales force, we will depend on arrangements with partners or other
entities for the marketing and sale of our proposed products.  Under
our agreement with Eli Lilly and Company, Lilly has an exclusive worldwide
license to market and sell any AD therapeutic that comes to market from our
collaboration agreements.  We do not currently have any agreements
with corporate partners or other entities to provide sales and marketing
services for our proposed diagnostic products.  We may not succeed in
entering into any satisfactory third-party arrangements





for the
marketing and sale of our proposed products, or we may not be able to obtain the
resources to develop our own marketing and sales capabilities.  We may
never have an AD therapeutic come to market under the Lilly agreements, or we
may never have a diagnostic product come to market.  The failure to
develop those capabilities, either externally or internally, may adversely
affect future sales of our proposed products.







We
are dependent on our key employees and consultants, who may not readily be
replaced.





We are highly dependent upon the
principal members of our management team, especially Craig S. Taylor, Ph.D., our
President and Chief Executive Officer, and Peter Davies, Ph.D., our founding
scientist, as well as our other officers and directors.  Our
consulting agreement with Dr. Davies is effective through November
2011.  We do not have an employment agreement with Dr.
Taylor.  We do not currently maintain key-man life insurance and the
loss of any of these persons' services, and the resulting difficulty in finding
sufficiently qualified replacements, could adversely affect our ability to
develop and market our products and obtain necessary regulatory
approvals.





Our success also will depend in part on
the continued service of other key scientific personnel, and our ability to
identify, hire and retain additional staff, if necessary.  We face
intense competition for qualified employees and consultants.  Large
pharmaceutical companies and other competitors, which have greater resources and
experience than we have, can, and do, offer superior compensation packages to
attract and retain skilled personnel.  As a result, we may have
difficulty retaining such employees and consultants because we may not be able
to match the packages offered by such competitors and large pharmaceutical
companies, and we may have difficulty attracting suitable
replacements.





We expect that our potential expansion
into areas and activities requiring additional expertise, such as clinical
trials, governmental approvals, contract manufacturing and sales and marketing,
will be done by working with outside contractors who have the appropriate
expertise or by utilizing collaborators/partners.  The management of
these processes may require an increase in management and scientific personnel
and the development of additional expertise by existing management
personnel.  The failure to attract and retain such personnel or to
develop such expertise could materially adversely affect prospects for our
success.





If
our current research collaborators, scientific advisors, and specifically our
founding scientist, Dr. Peter Davies, terminate their agreements with us, or
develop relationships with competitors, our ability to advance existing programs
and add new tools and technologies could be adversely impacted.





We derive significant support and
benefit from research collaborators and other expertise that we
utilize.  These collaborators are not our employees and operate under
consulting agreements that are subject to termination provisions.  Our
core technology in the AD field is based on exclusive licenses with AECOM
covering virtually all of our diagnostic and therapeutic applications in the
field of neurodegenerative diseases.  We therefore cannot control the
explicit amount of time or output that is derived from our collaborators through
our agreements.  Dr. Davies is currently actively deploying the time
and resources at his lab at AECOM that are necessary to advance our
collaboration agreements with Eli Lilly and Company as well as providing support
to our diagnostic development programs.  We may not derive any new or
additional tools or technologies from our relationship with Dr. Davies at AECOM,
that would be appropriate for us to develop, or that fall outside of the rights
of the Lilly collaboration.





We
use hazardous materials in our research and that may subject us to liabilities
in excess of our resources.





Our research and development involves
the controlled use of hazardous materials such as acids, caustic agents,
flammable solvents and carcinogens.  Although we believe that our
safety procedures for handling and disposing of hazardous materials comply in
all material respects with the standards prescribed by government regulations,
the risk of accidental contamination or injury from these materials cannot be
completely eliminated.  In the event of an accident, we could be held
liable for any damages that result.  Although we have insurance
coverage for third-party liabilities of this nature, such liability beyond this
insurance coverage could exceed our resources.  Our insurance for
hazardous materials liabilities has a deductible of $5,000 and a cap on coverage
for damages of $250,000.  There can be no assurance that current or
future environmental or transportation laws, rules, regulations or policies will
not have a material adverse effect on us.





If
we have any products used in clinical trials or products sold commercially,
potential product liability claims against us could result in reduced demand for
our products or extensive damages in excess of insurance
coverage.








The use of our products in clinical
trials or from commercial sales will expose us to potential liability claims if
such use, or even their misuse, results in injury, disease or adverse
effects.  We intend to obtain product liability insurance coverage
before we initiate clinical trials for any of our
products.   This insurance is expensive and insurance companies
may not issue this type of insurance when needed.  Any product
liability claim resulting from the use of our diagnostic test in a clinical
study, even one that was not in excess of our insurance coverage or one that is
meritless, could adversely affect our ability to complete our clinical trials or
obtain FDA approval of our product, which could have a material adverse effect
on our business.





The
healthcare reimbursement environment is uncertain and the consumer may not get
significant insurance reimbursement for our products, which could have a
materially adverse affect on our sales and our ability to sell our
products.





Recent efforts by governmental and
third-party payors, including private insurance plans, to contain or reduce the
costs of health care could affect the levels of revenues and profitability of
pharmaceutical, diagnostic and biotechnology products and
companies.  For example, in some foreign markets, pricing or
profitability of prescription pharmaceuticals is subject to government
control.  In the United States, there have been a number of federal
and state proposals to implement similar government control.  Pricing
constraints on our potential products could negatively impact revenues and
profitability.





In the United States and elsewhere,
successful commercialization of our products will depend in part on the
availability of reimbursement to the consumer using our products from
third-party health care payors.  Insufficient reimbursement levels
could affect demand for our products, and therefore, our ability to realize an
appropriate return on our investment in product
development.  Third-party health care payors are increasingly
challenging the price and examining the cost-effectiveness of medical products
and services.  If we succeed in bringing one or more products to
market, and the government or third-party payors fail to provide adequate
coverage or reimbursement rates for those products, it could reduce our product
revenues and profitability.





Our
stock price may fluctuate significantly due to reasons unrelated to our
operations, our products or our financial results.  Our stock price
may decrease if we have to issue a large number of shares of common stock in
order to raise the additional funds needed in 2010.





Stock prices for many technology
companies fluctuate widely for reasons which may be unrelated to operating
performance or new product or service announcements.  Broad market
fluctuations, earnings and other announcements of other companies, general
economic conditions or other matters unrelated to us or our operations and
outside our control also could affect the market price of the Common
Stock.  During the 2009 fiscal year, the highest closing price of our
stock was $1.50 and the lowest closing price of our stock during the same period
was $0.31.  At our current level of operations, we have sufficient
cash to last into the second quarter of 2010, and we will need to raise
additional funds in the second quarter of 2010.  In order to raise
additional funds, we may have to sell a significant number of shares of our
common stock and/or issue warrants exercisable to purchase shares of our common
stock.  While the inflow of additional funds may cause our stock price
to increase, the prospect of issuing, or the actual issuance of, a substantial
number of additional shares of common stock may cause our stock price to
decrease.





Our
share price may decline due to a large number of shares of our common stock
eligible for sale in the public markets and a large number of shares of our
common stock that could be issued upon the exercise of warrants and options
should our stock price increase to a level above the exercise price of the
warrants and options.





As of March 5, 2010, we had outstanding
4,404,375 shares of Common Stock, without giving effect to shares of Common
Stock issuable upon exercise of (i) warrants issued to SF Capital, exercisable
for 207,143 shares of our common stock, (ii) 363,881 options granted under our
stock option plan, (iv) 292,882 options granted outside of our stock option
plan, and (iv) 36,074 other warrants previously issued.  Of such
outstanding shares of common stock, all are freely tradable, except for any
shares not yet registered, shares underlying stock options that are not yet
vested, and any shares held by our "affiliates" within the meaning of the
Securities Act (officers, directors and 10% security holders), which shares will
be subject to the resale limitations of Rule 144 promulgated under the
Securities Act.  We will need to raise capital in the second quarter
of 2010 and this may cause us to issue additional shares of our common stock in
2010.








The
holders of our outstanding warrants and stock options may not exercise them, or
they may expire before we are able to receive any proceeds from the exercise of
these warrants and stock options.





As of March 5, 2010, we had 243,217
outstanding warrants and 656,763 outstanding stock options.  The
outstanding warrants have an average exercise price of $5.60 and have expiration
dates between 2011 and 2013.  The outstanding stock options have
exercise prices ranging from $0.65 to $45.00 and have expiration dates between
2010 and 2020.  We may not receive any significant proceeds from the
exercise of these outstanding warrants and stock options due to market
conditions and/or the expiration of the warrants and stock options prior to
exercise.  This could impact our future fund raising
options.





We
have not paid any dividends and do not anticipate paying dividends in the
foreseeable future.





A predecessor of Applied NeuroSolutions
liquidated most of its assets and paid a dividend to its shareholders in August
2001.  We have not paid cash dividends on our common stock, and we do
not anticipate paying cash dividends on our common stock in the foreseeable
future.  Investors who require dividend income should not rely on an
investment in our common stock to provide such dividend
income.  Potential income to investors in our common stock would only
come from any rise in the market price of our common stock, which is uncertain
and unpredictable.





A
limited market for our common stock and “penny stock” rules may make buying or
selling our common stock difficult.





Our common stock presently trades in
the over-the-counter market on the OTC Bulletin Board. As a result, an investor
may find it difficult to sell, or to obtain accurate quotations as to the price
of our securities.  In addition, our common stock is subject to the
penny stock rules that impose additional sales practice requirements on
broker-dealers who sell such securities to persons other than established
customers and accredited investors.  The SEC regulations generally
define a penny stock to be an equity that has a market price of less than $5.00
per share, subject to certain exceptions.  Unless an exception is
available, those regulations require the delivery, prior to any transaction
involving a penny stock, of a disclosure schedule explaining the penny stock
market and the risks associated therewith and impose various sales practice
requirements on broker-dealers who sell penny stocks to persons other than
established customers and accredited investors (generally institutions and high
net worth individuals).  In addition, the broker-dealer must provide
the customer with current bid and offer quotations for the penny stock, the
compensation of the broker-dealer and its salesperson in the transaction and
monthly account statements showing the market value of each penny stock held in
the customer's account.  Moreover, broker-dealers who recommend such
securities to persons other than established customers and accredited investors
must make a special written suitability determination for the purchaser and
receive the purchaser's written agreement to transactions prior to
sale.  Regulations on penny stocks could limit the ability of
broker-dealers to sell our common stock and thus the ability of purchasers of
our common stock to sell their shares in the secondary market.





Our
disclosure controls and procedures and our internal controls over financial
reporting are not adequate and may result in our failure to disclose items that
we may be required to disclose under the Securities Act or the Securities
Exchange Act or may result in financial statements that are incomplete or
subject to restatement.





Section 404 of the Sarbanes Oxley Act
of 2002 (“Section 404”) requires significant additional procedures and review
processes of our system of internal controls.  Section 404 requires
that we evaluate and report on our system of internal controls over financial
reporting beginning with the Annual Report on Form 10-K for the year ended
December 31, 2007.  In addition, our independent auditors must report
on management’s evaluation of those controls for the year ending December 31,
2010.  Our internal controls under Section 404 may not be
adequate.  The additional costs associated with this process may be
significant and any costs incurred for external evaluation, consulting, testing
and documenting of our system may not alleviate any material
weaknesses.  After our internal documenting and testing of our system,
we have identified the following material weaknesses:





·
            We
      lack segregation of duties in the period-end financial reporting process,
      and


·
            Our
      accounting software has inherent control
  deficiencies.








Due to
these material weaknesses, our chief executive officer and chief financial
officer concluded that as of December 31, 2009, our disclosure controls and
procedures were not effective to ensure that information required to be
disclosed by us in reports that we file or submit under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified
in SEC rules and forms.  Additionally, our Chief Financial Officer
resigned his full-time position with the Company effective March 5,
2010.  As a result, our Chief Executive Officer will act as our Chief
Financial Officer until a replacement is hired, further limiting the segregation
of duties in the period-end financial reporting
process.  Consequently, we may fail to disclose items that we are
required to report in our SEC filings, including registration statements, proxy
statements and periodic reports.  If we are required to amend prior
reports as a result of failing to disclose required information, investors may
react adversely to such amendments and our stock price may
decrease.





Our
Independent Registered Public Accountants have substantial doubt about our
ability to continue as a going concern.





We have
had net losses for each of the years ended December 31, 2009 and 2008, and we
have an accumulated deficit as of December 31, 2009.  Since the
financial statements for each of these periods were prepared assuming that we
would continue as a going concern, in the view of our independent registered
public accountants, these conditions raise substantial doubt about our ability
to continue as a going concern.  We anticipate that our cash balances
at December 31, 2009, should be sufficient to fund our current level of
operations into the second quarter of 2010.  We will need additional
funding in the second quarter of 2010 in order to continue our research, product
development and our operations.  Since we do not expect to generate
any material revenues for the foreseeable future, our ability to continue as a
going concern depends, in large part, on our ability to raise additional capital
in the second quarter of 2010, either through some form of collaboration or
joint venture or debt or equity financing, which may include the exercise of
outstanding stock options and/or warrants.  If we are unable to raise
additional capital, we may be forced to discontinue our business.





ITEM
2.                      PROPERTIES





We lease approximately 7,500 square
feet of office and laboratory space in Vernon Hills, Illinois at an annual
rental of approximately $125,000.Our
current lease agreement expired in May 2007 and was renewed for a three-year
period ending May 2010 at a slightly reduced base rent.





ITEM
3.                      LEGAL
PROCEEDINGS





We are not currently involved in any
legal proceedings.





ITEM
4.                      SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS





None.





PART
II





ITEM
5.                      MARKET
FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES
OF EQUITY SECURITIES





Our common stock is quoted on the OTC
(Over-the-Counter) Bulletin Board and traded under the symbol,
"APSN".  Prior to July 1, 2009, our common stock was traded on the OTC
Bulletin Board under the symbol “APNS”.  Prior to November 25, 2003,
our common stock was traded on the OTC Bulletin Board under the symbol
“HMYD”.  Our common stock was previously traded on the OTC Bulletin
Board under the symbol “OPHD” until February 5, 2002.





The following table sets forth the
range of high and low daily last sale prices for our common stock, from January
1, 2008 through December 31, 2009 (adjusted for our 1-for-30 reverse stock split
in June 2009), and for each of the quarterly periods indicated as reported by
the OTC Bulletin Board.











High
            
            
            Low2008:First
      quarter
            
            $
            3.90
            
            
            $
            2.70Second
      quarter
            
            
            3.00
            
            
            
            1.80Third
      quarter
            
            
            2.40
            
            
            
            1.50Fourth
      quarter
            
            
            1.80
            
            
            
            0.602009:First
      quarter
            
            $
            1.20
            
            
            $
            0.50Second
      quarter
            
            
            0.81
            
            
            
            0.33Third
      quarter
            
            
            1.50
            
            
            
            0.31Fourth
      quarter
            
            
            1.40
            
            
            
            0.31





As of March 5, 2010, we had
approximately 2,100 record holders of our common stock.  We estimate
that as of such date, there were more than 2,000 beneficial holders of our
common stock.





No dividends were paid in 2008 and
2009.  There are no restrictions on the payment of
dividends.  We do not intend to pay dividends for the foreseeable
future.





All of our securities that were issued
or sold by us since March 15, 2001, have been registered with the SEC, except a)
88,889 stock options issued outside our Stock Option Plan in 2006, b) 203,993
stock options issued outside our Stock Option Plan in 2009, c) 56,329 shares of
restricted common stock issued in 2006 through 2009, and d) 3,515 warrants
issued in 2008.  All of these issuances were made in reliance upon the
exemption set forth in Section 4(2) of the Securities Act of 1933.  We
filed an SB-2 registration statement in July 2004, an S-8 registration statement
in December 2004, and an SB-2 registration statement in November 2007. An S-8
registration statement is expected to be filed in the second quarter of 2010 to
register the stock options, restricted common stock and warrants noted
above.








ITEM
6.                      SELECTED
FINANCIAL DATA





Not
applicable.





ITEM
7.                      MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS





The following discussion of the
financial condition and results of operations of the Company should be read in
conjunction with the financial statements and the related notes thereto included
in this document.








OVERVIEW


Applied
NeuroSolutions, Inc. (“APNS” or “the Company” or “we”) is a development stage
biotechnology company focused on the development of products for the early
diagnosis and treatment of Alzheimer's disease (“AD” or
“Alzheimer’s”).





Alzheimer’s
Disease


Alzheimer’s disease is the most common
cause of dementia among people age 65 and older.  Dementia is the loss
of memory, reason, judgment and language to such an extent that it interferes
with a person’s daily life and activities.  Currently it is estimated
that over five million people in the U.S., and almost 35 million worldwide, have
Alzheimer’s disease and the national cost of caring for people with Alzheimer’s
is estimated to exceed $148 billion annually.  By 2050, it is
estimated that 16 million people in the U.S. will have Alzheimer’s, and the
global prevalence of Alzheimer’s is expected to be greater than 115
million.





Diagnostic
Programs


We are focused on developing
serum-based tests to detect AD at an early stage in the disease
process.  In July 2009, we announced we had achieved feasibility in
our development of a serum-based test related to the diagnosis of patients with
AD, and we provided an update in October 2009.  The results of two
limited studies achieved sufficient analytical sensitivity to detect tau in
serum patient samples.  The protein tau is directly linked to the
pathology of Alzheimer’s disease.  This is a key step in the
development of a blood-based test to detect AD.  Based on a further
analysis of the preliminary data, we believe additional development of the
assay, including optimization and validation in key patient population groups,
is necessary to determine the specific sensitivity and specificity performance
of the assay.  Our focus is on advancing the development of a
blood-based test for AD to commercialization in 2011, through reference labs
under the Clinical Laboratory Improvement Amendment of 1988
(“CLIA”).  Clinical laboratories regulated under the CLIA, qualified
to perform high complexity testing, can provide physicians with test results
utilizing in-house diagnostic tests using Analyte specific reagents (“ASR's”),
restricted devices under section 520(e) of the Federal Food, Drugs, and Cosmetic
Act.  We plan to provide our reference laboratory partner with our
proprietary ASR’s and materials.  A serum-based test could be used not
only as an aide to early diagnosis of AD, but also as part of a routine annual
physical to rule out Alzheimer’s disease.  Our key milestones in the
development of a serum-based test and the estimated timeframe for achieving each
milestone are listed below:





Serum-Based Diagnostic Key
Milestones





Feasibility               
Completed


Optimization           
Mid 2010


Validation                
2nd half
2010


Reference Lab Partnership1st half
2011


U.S. Commercialization2nd half
2011








We have developed a cerebrospinal fluid
(“CSF”)-based test that can detect AD at an early stage as well as identify
patients with mild cognitive impairment (“MCI”) who are most likely to progress
to AD.  In a research setting, our CSF-based test, which detects a
certain AD associated protein found in the CSF of AD patients (“P-Tau 231”), has
demonstrated an ability to differentiate AD patients from those with other
diseases that have similar symptoms. This test is based on extensive testing in
the APNS lab, utilizing in excess of 2,500 CSF samples to differentiate patients
diagnosed with AD from patients diagnosed with other forms of dementia and
relevant neurological diseases, including major depression, as well as
age-matched healthy controls.  The CSF-based P-Tau 231 test has
demonstrated, based on published research validation studies, overall
sensitivity and specificity in the range of 85% to 95%.








Therapeutic
Program – Collaboration with Eli Lilly and Company


In November 2006, we entered into a
collaboration agreement with Eli Lilly and Company (“Lilly”).  APNS
and Lilly are engaged in the discovery and development of novel therapeutics for
the development of treatments for Alzheimer’s disease based upon an approach
developed by Dr. Peter Davies, our founding scientist.  As a result of
Dr. Davies’ research, APNS and Lilly are focused on discovery of unique
therapeutics that may be involved in a common intracellular phosphorylation
pathway leading to the development of the abnormal, destructive brain
structures, amyloid plaques and neurofibrillary tangles, that are characteristic
of Alzheimer’s disease.  APNS has identified various biomarkers that
we believe will aid in the development of diagnostics and drug specific
diagnostic markers that could also play a role in the development of new AD
treatments.





Lilly will, based on the achievement of
certain defined milestones, provide us over time with up to a total sum of $20
million in milestone payments for advancing the APNS proprietary target to a
therapeutic compound.  The collaboration has also made progress on
other targets that are part of the collaboration that could provide milestone
payments to us over time of up to a total sum of $10 million for advancing each
of these other targets to a therapeutic compound.  Royalties are to be
paid to us for AD drug compounds brought to market that result from the
collaborations.  Lilly will fund the vast majority of all pre-clinical
research and development and will fully finance the clinical testing,
manufacturing, sales and marketing of AD therapeutics developed from this
collaboration.





The collaboration has achieved
significant internal milestones to date.  The next milestone, which if
reached would result in our receipt of a cash payment from Lilly is currently
expected in 2010.  Lilly remains fully committed to the collaboration
with resources focused on program progress and milestone
achievement.  The collaboration continues to make progress with
additional tau-based targets with various screens established and studies
underway.





In November 2009, we agreed to a
one-year renewal of our drug discovery collaboration with Lilly.  We
received $250,000 in December from Lilly for this renewal.  In
December 2009, we reached agreement with Lilly to increase the scope of our drug
discovery collaboration.  In addition to the financial terms from the
original collaboration agreement with Lilly announced in 2006, we received a
cash payment of $750,000 in December upon signing the agreement and may receive
up to $25.5 million based on achievement of identified
milestones.  Royalties would be paid to us for any AD therapies
brought to market that result from this addition to the original collaboration
agreement.





Our
key milestones in our collaboration with Lilly, and the current estimated
timeframe for achieving each milestone are listed below:








Collaboration with Lilly Key
Milestones





Target # 1Expected Completion
Date


Lead Declaration2010


Candidate Selection2012


IND filing2013





Additional
Targets


Portfolio Entry2010











Research
Products and Services


We market a transgenic mouse containing
the human tau gene that develops human paired helical filaments, the building
blocks of the neurofibrillary tangles, which are known to be involved in the
pathology of Alzheimer’s disease. The pathology in these mice is Alzheimer-like,
with hyperphosphorylated tau accumulating in cell bodies and dendrites as
neurofibrillary tangles.  In addition, these transgenic mice have exhibited
extensive neuronal death that accompanies the tau pathology.  These
transgenic mice could be used for testing the efficacy of therapeutic
compounds.  To date, no widely accepted animal model that exhibits both AD
pathologies has been developed.  The mice are currently available through
Jackson Laboratories.








We also provide diagnostic services to
pharmaceutical companies.  Since 2003 we have analyzed approximately
1,500 clinical trial samples with our CSF phosphotau diagnostic assay and have
generated approximately $650,000 in revenue.  In addition to
generating revenue for us, these research agreements provide useful data to
validate our CSF phosphotau assay.





Liquidity
and Capital Resources





As of December 31, 2009, we had cash of
$794,003.  We anticipate that our cash balances at December 31, 2009
should be sufficient to fund our current level of operations into the second
quarter of 2010.  On March 10, 2010, we entered into a Securities
Purchase Agreement (the “Agreement”) with an outside investor providing for the
issuance of an 8% Secured Convertible Note due December 10, 2010, in the
principal amount of $100,000 (the “Note”).  The Note is convertible at
any time prior to maturity into shares of our common stock at a variable
conversion price generally equal to 62.5% of the average of the daily dollar
volume-weighted average sale price of our common stock over the ten consecutive
trading days immediately preceding the date on which the conversion price is
being determined.  We will need to raise additional funds in the
second quarter of 2010 in order to continue our research, product development
and our operations.  The cash on hand will be used for ongoing
research and development, working capital, general corporate purposes and
possibly to secure appropriate partnerships and expertise.  We will be
required to raise additional capital in financing transactions or through some
form of collaborative partnership in order to satisfy our expected cash
expenditures after the second quarter of 2010.  We expect to raise
such additional capital by selling shares of our capital stock, proceeds from
exercises of existing warrants and/or stock options and/or by borrowing
money.  However, such additional capital may not be available to us at
acceptable terms or at all.  As of March 5, 2010, we have
approximately 94,700,000 authorized shares of common stock available for
issuance, which are sufficient available authorized shares of common stock to
issue in a funding and for other uses as deemed appropriate by our Board of
Directors.  Further, if we sell additional shares of our capital
stock, current ownership positions in our Company will be subject to dilution.
In the event that we are unable to obtain additional capital, we may be forced
to further reduce key operating expenditures or to cease operations
altogether.





If we are successful in achieving our
next milestone to increase the sensitivity and specificity of our serum-based
diagnostic test, while significantly increasing the analysis of patient samples,
we believe the Company could begin generating revenue from our serum diagnostic
program in 2011 under the Clinical Laboratory Improvement Amendment of 1988
(“CLIA”).  Clinical laboratories regulated under the CLIA, qualified
to perform high complexity testing, can provide physicians with test results
utilizing in-house diagnostic tests using Analyte specific reagents (“ASR's”),
restricted devices under section 520(e) of the Federal Food, Drugs, and Cosmetic
Act.  We plan to provide our reference laboratory partner with our
proprietary ASR’s and materials.  The reference laboratory(ies)
performing the tests are required to inform the ordering person of the
diagnostic test result that, “This test was developed and its performance
characteristics determined by (Laboratory Name).  It has not been
cleared or approved by the U.S. Food and Drug Administration."  In
order to sell our serum-based diagnostic test under CLIA, we would need to
contract or partner with a CLIA certified lab.





We do not
anticipate the purchase, lease or sale of any significant property and equipment
during 2010.  We do not anticipate any significant changes in our
employee count during 2010.





Critical
Accounting Policies and Estimates





Our consolidated financial statements
have been prepared in accordance with accounting principles generally accepted
in the United States of America.  The consolidated financial
statements include the accounts of APNS and its wholly-owned subsidiaries prior
to our dissolution of our subsidiaries in 2004.  All significant
intercompany balances and transactions have been eliminated.  The
preparation of these financial statements requires our management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and the disclosure of contingent assets and liabilities at the date
of the financial statements and the reported amounts of revenues and expenses
during the reporting period.





On an on-going basis, our management
evaluates its estimates and judgments, including those related to tax valuation
and equity compensation.  Our management bases its estimates and
judgments on historical experience and on various other factors that are
believed to be reasonable under the circumstances.  Actual results may
differ





from
these estimates under different assumptions or conditions.  Our
management believes the following critical accounting policies, among others,
affect our more significant judgments and estimates used in preparation of these
consolidated financial statements.





Revenue
Recognition





We generate revenues from research
agreements and collaborations, and in the past, we also generated revenues from
grants.  Revenue is recognized when earned.  Grant revenues
represent funds received from certain government agencies for costs expended to
further research on the subject of the grant.  In accordance with
current accounting literature, if revenue arrangements contain multiple
deliverables, we separate the deliverables into separate accounting units if
they meet all of the following:  a) the delivered items have
stand-alone value to the customer; b) the fair value of any undelivered items
can be reliably determined; and c) if the arrangement includes a general right
of return, delivery of the undelivered items if probable and substantially
controlled by the seller.  Deliverables that do not meet these
criteria are combined with one or more other deliverables into one accounting
unit.  Revenue from each accounting unit is recognized based on the
applicable accounting literature.





Research and
Development





All research and development costs are
expensed as incurred and include salaries of, and expenses related to, employees
and consultants who conduct research and development.  We have, from
time to time, entered into arrangements whereby we will obtain research
reimbursement in the form of funds received to partially reimburse us for costs
expended.





Income Taxes and Net
Deferred Tax Asset Valuation Allowance





The carrying value of our deferred tax
assets is dependent upon our ability to generate sufficient future taxable
income in certain tax jurisdictions. Should we determine that it is more likely
than not that some portion or all of our deferred tax assets will not be
realized, a valuation allowance to the deferred tax assets would be established
in the period such determination was made. At December 31, 2009, a valuation
allowance has been established for the entire amount of deferred tax
assets.





It is our policy to provide for
uncertain tax positions and the related interest and penalties based upon our
management's assessment of whether a tax benefit is more likely than not to be
sustained upon examination by tax authorities.  At December 31, 2009,
our management believes there were not any unrecognized income tax benefits
and/or liabilities.





Stock-Based
Compensation





We record share-based payment awards
exchanged for employee services at fair value on the date of grant and expense
the awards in the consolidated statements of operations over the requisite
employee service period.  Stock-based compensation expense includes an
estimate for forfeitures and is generally recognized over the expected term of
the award on a straight-line basis.  Stock-based compensation expense
related to awards with a market or performance condition is recognized over the
expected term of the award utilizing the graded vesting method.  The
fair value of stock options is determined using the Black-Scholes valuation
model and the assumptions shown in Note 1(i) of the Notes to the Consolidated
Financial Statements.  The assumptions used in calculating the fair
value of share-based payment awards represent our management's best
estimates.  These estimates may be impacted by certain variables
including, but not limited to, stock price volatility, employee stock option
exercise behaviors, additional stock option grants, estimates of forfeitures,
the company's performance, and related tax impacts.





Recent
Accounting Pronouncements





In June 2009, the FASB issued
Accounting Standards Update 2009-01, “The FASB Accounting Standards
Codification and the Hierarchy of Generally Accepted Accounting
Principles”(“ASU 2009-01”).  ASU 2009-01 or the
FASB Accounting Standards Codification (“Codification”) will become the source
of authoritative U.S. generally accepted accounting principles (“GAAP”)
recognized by the FASB to be applied by nongovernmental entities.  On
the effective date of ASU 2009-01, the Codification will supersede all
then-existing non-SEC





accounting
and reporting standards.  All other non-grandfathered, non-SEC
accounting literature not included in the Codification will become
non-authoritative.  ASU 2009-01 is effective for financial statements
issued for interim and annual periods ending after September 15,
2009.  The adoption of the standard did not have a material impact on
the Company’s consolidated balance sheets, statements of operations,
or cash flows.





Results
of Operations





The following discussion of the
financial condition and results of operations should be read in conjunction with
the consolidated financial statements and notes thereto included in Item
8.







Year
Ended December 31, 2009 Compared to Year Ended December 31, 2008





Revenues





We recognized $1,551,399 of revenues in
2009 primarily from the recognition of the remaining eleven months of our
initial funds received from our 2006 collaboration with Eli Lilly and Company
and $750,000 received in 2009 for an increase in the scope of our original
collaboration with Lilly.  We recognized $838,133 of revenues in 2008
primarily from the recognition of twelve months of our initial funds received
from our 2006 collaboration with Eli Lilly and Company.





Research
and development





Research and development expenses
consist primarily of compensation of personnel and related benefits and taxes,
funding for research and development programs, funding of research related to
license agreements, scientific consultant expenses and overhead
costs.  Research and development expenses for the year ended December
31, 2009 decreased 10% or $151,654 to $1,319,874 from $1,471,528 for the year
ended December 31, 2008.  Below is a summary of our research and
development expenses:





IncreaseExpense
            
            2009
            
            
            2008
            
            
            (Decrease)Compensation,
      taxes and benefits
            
            $
            363,952
            
            
            $
            441,262
            
            
            $
            (77,310
            )Program
      R & D funding, license fees and consulting
            
            
            816,438
            
            
            
            870,853
            
            
            
            (54,415
            )Rent,
      telephone and utilities
            
            
            108,027
            
            
            
            112,304
            
            
            
            (4,277
            )Other
      research and development expenses
            
            
            31,457
            
            
            
            47,109
            
            
            
            (15,652
            )Total
      Research and Development Expenses
            
            $
            1,319,874
            
            
            $
            1,471,528
            
            
            $
            (151,654
            )





This decrease was primarily due to a
decrease in compensation related expenses and a decrease in our program R &
D funding to advance the development of our serum-based AD diagnostic
programs.  The decrease in compensation related expenses is due to a
reduction in benefits and a decrease in costs of ongoing benefits as well as the
elimination of one technician position in February 2008 and an additional
technician position in July 2009.  Prior to July 2009, we had been
providing more resources for our program R & D funding, however, in July
2009, we temporarily scaled back our diagnostic R&D programs due to funding
constraints.  There was no non-cash expense for stock based payments
in 2009 and 2008.  If we are able to raise sufficient funds to
continue our diagnostic programs, we estimate that we may incur costs of
approximately $100,000 to $150,000 per month on research and development
activities going forward.  This excludes the non-cash effect of
accounting for equity instruments included in the amounts mentioned
above.  These expenditures, however, may fluctuate from
quarter-to-quarter and year-to-year depending upon the resources available, our
development schedule, and our progress.  Results of preclinical
studies, clinical trials, regulatory decisions and competitive developments for
our diagnostic programs may significantly increase the amount of our research
and development expenditures.





General
and administrative





General and administrative expenses
consist primarily of compensation of personnel and related benefits and taxes,
public company compliance expenses, including legal and accounting expenses, and
occupancy related expenses.  General and administrative expenses for
the year ended December 31, 2009 decreased 22% or $363,001





to
$1,279,011 from $1,642,012 for the year ended December 31,
2008.  Below is a summary of our general and administrative
expenses:





IncreaseExpense
            2009
            2008
            (Decrease)Compensation,
      taxes and benefits
            $578,290
            $693,250
            $     (114,960)Consulting
            72,000
            105,377
            (33,377)Professional
      fees
            194,355
            298,176
            (103,821)Rent,
      telephone and utilities
            40,435
            43,550
            (3,115)Stock
      option compensation expense
            260,292
            306,014
            (45,722)Other
      general and administrative expenses
            133,639
            195,645
            (62,006)Total
      General and Administrative Expenses
            $1,279,011
            $1,642,012
            $(363,001)





This decrease is primarily due to
across the board cost reductions.  The decrease in compensation
related expenses is due to a reduction in benefits and a decrease in costs of
ongoing benefits as well as the elimination of one administrative position in
July 2009 and reduced compensation costs for our executive
officers.  The decrease in consulting is primarily due to a one-time
business development consulting contract in the second quarter of
2008.  The decrease in professional fees is due to a reduction in
costs associated with patent expenses and patent maintenance costs and a
decrease in general legal expenditures.  Compensation expense for all
stock based payments is required to be measured and recognized at fair
value.  Non-cash expense for all stock based payments in 2009 was
$260,292 and in 2008 was $306,014.  Other expenses decreased primarily
due to the cost of our shareholder meeting in the third quarter of
2008.  If we are able to raise sufficient funds to continue our
diagnostic programs, we estimate that we may incur costs of approximately
$80,000 to $130,000 per month on general and administrative activities going
forward.  This excludes the non-cash effect of accounting for equity
instruments included in the amounts mentioned above.  These
expenditures, however, may fluctuate from quarter-to-quarter and year-to-year
depending upon the resources available, SEC requirements, and our development
schedule.





Other
income and expense





Interest expense for the year ended
December 31, 2009 was $64,060, due to accrued interest related to the $535,000
notes payable.  We did not incur any interest expense for the year
ended December 31, 2008.  Interest income for the year ended December
31, 2009 decreased 91% or $39,235, to $3,804 from $43,039 for the year ended
December 31, 2008.  The decrease is primarily due to lower average
invested balances and a lower rate of return.





We currently do not hedge foreign
exchange transaction exposures.  As of December 31, 2009, we do not
have any assets denominated in foreign currencies.  At December 31,
2009 and 2008, we did have amounts due in euros to a European
collaborator.  Included in accounts payable at December 31, 2009 was
an estimate of $21,682 due to this collaborator.  This amount due was
settled for $21,527 in January 2010.  Included in accounts payable at
December 31, 2008 was an estimate of $50,935 due to this
collaborator.  This amount due was settled for $50,005 in January
2009.





Net
loss





We incurred a net loss of $1,107,742
for the year ended December 31, 2009 compared to a net loss of $2,232,368 for
the year ended December 31, 2008.  The primary reasons for the
$1,124,626 decrease in the net loss in 2009 were the $750,000 in revenue
recognized in 2009 from the increase in the scope of our collaboration agreement
with Eli Lilly and Company, the $114,960 decrease in G & A compensation and
related taxes and benefits, the $103,821 decrease in professional fees, the
$77,310 decrease in R & D compensation and related taxes and benefits, the
$62,006 decrease in other G & A expenses and the $54,415 decrease in program
R & D funding.  This was partially offset by a $64,060 increase in
interest expense in 2009.





Capital
resources and liquidity





To date, we have raised equity and
convertible debt financing and received research agreement revenues,
collaboration revenues and grant revenues to fund our operations, and we expect
to continue this practice to fund our ongoing operations.  Since
inception, we have raised net proceeds of approximately $42.6 million from
private





equity
and convertible debt financings.  We have also received approximately
$5.9 million from research agreements, collaboration revenues and grant
revenues.





Our cash and cash equivalents were
$794,003 and $1,045,020 at December 31, 2009 and 2008,
respectively.  The decrease in our cash balance is due to the cash
used in operations in 2009, less the $1,000,000 received from Eli Lilly and
Company in 2009 and $35,000 in convertible debt funding received in January
2009.





Net cash used in operating activities
was $283,742 for the year ended December 31, 2009 versus net cash used in
operating activities of $2,414,138 for the year ended December 31,
2008.  This decrease reflects an overall reduction in expenses in
2009, plus an increase in liabilities due to deferral of payments to AECOM in
2009, that was partially offset by $1,000,000 of revenue received in
2009.  Cash used in investing activities was negligible in 2009 and
2008.  Net cash provided by financing activities was $35,000 in 2009
and $500,000 in 2008 due to the proceeds from convertible notes received each
year.





We have incurred recurring losses since
our inception and expect to incur substantial additional research and
development costs prior to reaching profitability.  We incurred
research and development costs of $1,319,874 in 2009 and $1,471,528 in
2008.  Prior to 2007, virtually all of our research and development
costs were internal costs and license costs which were not specifically
allocated to any of our research and development projects.  Beginning
in 2007, an increasing amount of our research and development costs are being
specifically allocated to our research and development
projects.  Through a restructuring, we eliminated a senior scientific
management position in November 2007, a staff scientist position in February
2008, and another staff scientist position in July 2009.  The
compensation that had been utilized for the scientists is now being allocated to
direct R & D projects and working with outside companies and consultants to
obtain specific expertise and access to technologies to assist us in advancing
our programs.  We anticipate that our cash balances as of December 31,
2009, will be sufficient to cover our planned research and development
activities and general operating expenses into the second quarter of
2010.  We will need additional funding in the second quarter of 2010
to cover operations.  If additional funding is not obtained, we will
not be able to fund the costs of any programs in development.  This
would have a material adverse effect on our operations and our
prospects.





As we currently do not have any
approved products in the marketplace, we do not have a time frame for generating
significant revenues from our research and development activities.





We currently do not have sufficient
resources to maintain operations and complete the development of our proposed
research projects.  Therefore, we will need to raise additional
capital in the second quarter of 2010 to fund our operations.  We
cannot be certain that any financing will be available when needed, or on terms
acceptable to us.  If we fail to raise additional financing as we need
it, we may have to delay or terminate our own product development programs or
pass on opportunities to in-license or otherwise acquire new products and/or
technologies that we believe may be beneficial to our business.  We
may spend capital on:





•      research
and development programs;


•      pre-clinical
studies and clinical trials; and


•      regulatory
processes.





The
amount of capital we may need will depend on many factors, including
the:





•      progress,
timing and scope of research and development programs;


•      progress,
timing and scope of our pre-clinical studies and clinical trials;


•      time and
cost necessary to obtain regulatory approvals;


•      time and
cost necessary to seek third-party manufacturers to manufacture our products for
us;


•      time and
cost necessary to seek marketing partners to market our products for
us;


•      time and
cost necessary to respond to technological and market developments;


•      changes
made to, or new developments in, our existing collaborative, licensing and
other


commercial relationships;
and


•      new
collaborative, licensing and other commercial relationships that we may
establish.














Off-Balance
Sheet Arrangements





We have no off-balance sheet
arrangements.





Commitments





We have several financial commitments,
including those relating to our license agreements with Albert Einstein College
of Medicine (“AECOM”).





Under our license agreements with
AECOM, we are required to:


•      pay
semi-annual maintenance payments in January and July each year;


•
            pay
      quarterly funding payments in February, May, August and November each year
      as long as the license agreements are in place;
  and


•      pay the
costs of patent prosecution and maintenance of the patents included in the
agreement.





In December 2008, AECOM agreed to defer
the 2009 semi-annual maintenance payments until the earlier of December 31, 2009
or a fund raise at least equal to $3,500,000. In exchange for this deferral, we
agreed to prepay the quarterly funding payments to support Dr. Davies lab at
AECOM that were due in February 2009, May 2009 and August 2009.  This
prepayment of $112,500 was made in December 2008.  In November 2009,
AECOM agreed to defer the 2009 semi-annual maintenance payments that had
previously been deferred until December 31, 2009 and the 2010 semi-annual
maintenance payments until the earlier of December 31, 2010 or a fund raise at
least equal to $4,000,000. AECOM also agreed to defer the quarterly funding
payment to support Dr. Davies lab at AECOM that was due in November 2009 until
February 2010.





Our fixed expenses, such as rent,
license payments and other contractual commitments, may increase in the future,
as we may:


•      enter into
additional leases for new facilities and capital equipment;


•      enter into
additional licenses and collaborative agreements; and


•      incur
additional expenses associated with being a public company.





In addition to the commitments to
AECOM, we also have a consulting agreement with Dr. Peter Davies, our founding
scientist, through November 2011, and minimum annual lease payments on our
office and lab facility in Vernon Hills, Illinois through May
2010.  In December 2008, Dr. Davies agreed to defer a portion of his
monthly consulting fees.  In December 2009, we agreed to repay him
these deferred consulting fees over twelve months in 2010.





The following table summarizes the
timing of these future long term contractual obligations and commitments for the
next five years ending December 31:





Contractual
      Obligations
            
            2010
              Year
      1
            
            
            2011
              Year
      2
            
            
            2012
              Year
      3
            
            
            2013
              Year
      4
            
            
            2014
              Year
      5
            
            
            TotalOperating
      Leases
            
            $
            37,266
            
            
            $
            -
            
            
            $
            -
            
            
            $
            -
            
            
            $
            -
            
            
            $
            37,266Consulting
      Agreements with initial terms greater than one year
            
            
            175,500
            
            
            
            99,000
            
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            274,500Commitments
      Under License Agreement with AECOM
            
            
            887,500
            
            
            
            500,000
            
            
            
            500,000
            
            
            
            500,000
            
            
            
            500,000
            
            
            
            2,887,500Total
      Contractual Cash Obligations
            
            $
            1,100,266
            
            
            $
            599,000
            
            
            $
            500,000
            
            
            $
            500,000
            
            
            $
            500,000
            
            
            $
            3,199,266





We are obligated to continue to pay
AECOM $500,000 for each year in which the Agreements are still in
effect.  In addition, we are obligated to pay AECOM a percentage of
all revenues we receive from selling and/or licensing aspects of the AD
technology licensed under the Agreements that exceeds the minimum obligations
reflected in the annual license maintenance payments.  The future
long-term contractual obligations and commitments for 2010 include all amounts
deferred from 2009 that are scheduled to be paid in 2010.














ITEM
7A.                      QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK





Not applicable.





ITEM
8.                      
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA











APPLIED
NEUROSOLUTIONS, INC.


(a
development stage company)




FINANCIAL
STATEMENTS











Contents





PageReport
      of Independent Registered Public Accounting Firm
            29Consolidated
      Balance Sheets as of December 31, 2009 and 2008
            30Consolidated
      Statements of Operations for the Years Ended December 31, 2009 and 2008,
      and for the Cumulative Period From March 14, 1992 (inception) to December
      31, 2009
            31Consolidated
      Statements of Stockholders’ Equity/(Deficit) for the Years Ended December
      31, 2009 and 2008, and for the Cumulative Period From March 14, 1992
      (inception) to December 31, 2009
            32-34Consolidated
      Statements of Cash Flows for the Years Ended December 31, 2009 and 2008,
      and for the Cumulative Period From March 14, 1992 (inception) to December
      31, 2009
            35-36Notes
      to Consolidated Financial Statements for the Years Ended December 31, 2009
      and 2008, and for the Cumulative Period From March 14, 1992 (inception) to
      December 31, 2009
            37-55























REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM











To the
Stockholders, Audit Committee and Board of Directors


Applied
NeuroSolutions, Inc.


Vernon
Hills, Illinois








We have
audited the accompanying consolidated balance sheets of Applied NeuroSolutions,
Inc. (a development stage company) as of December 31, 2009 and 2008, and the
related consolidated statements of operations, shareholders' equity/(deficit)
and cash flows for the years then ended.  These consolidated financial
statements are the responsibility of the company's management.  Our
responsibility is to express an opinion on these consolidated financial
statements based on our audits.





We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States).  Those standards require
that we plan and perform the audit to obtain reasonable assurance about whether
the consolidated financial statements are free of material
misstatement.  The Company is not required to have, nor were we
engaged to perform, an audit of its internal control over financial
reporting.  Our audit included consideration of its internal control
over financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company's internal control over financial
reporting.  Accordingly, we express no such opinion.  An
audit includes examining, on a test basis, evidence supporting the amounts and
disclosures in the consolidated financial statements.  An audit also
includes assessing the accounting principles used and significant estimates made
by management as well as evaluating the overall consolidated financial statement
presentation.  We believe that our audits provide a reasonable basis
for our opinion.





In our
opinion, the consolidated financial statements referred to above present fairly,
in all material respects, the financial position of Applied NeuroSolutions, Inc.
(a development stage company) as of December 31, 2009 and 2008 and the results
of their operations and their cash flows for the years then ended, in conformity
with U.S. generally accepted accounting principles.








The
accompanying consolidated financial statements have been prepared assuming that
the Company will continue as a going concern. As discussed in Note 1(c) to the
consolidated financial statements, the Company has suffered recurring losses
from operations, has an accumulated deficit and requires additional capital to
support the Company's continued development efforts, which raises substantial
doubt about its ability to continue as a going concern.  Management’s
plans in regard to these matters are also described in Note 1(c).  The
consolidated financial statements do not include any adjustments that might
result from the outcome of this uncertainty.








/s/ Baker
Tilly Virchow Krause, LLP





Chicago,
Illinois


March 24,
2010




















APPLIED
NEUROSOLUTIONS, INC.


(a
development stage company)




CONSOLIDATED
BALANCE SHEETS







December
      31,
            
            
            December
      31,2009
            
            
            2008Assets
              Current
      assets:Cash
            
            $
            794,003
            
            
            $
            1,045,020Accounts
      receivable
            
            
            -
            
            
            
            4,800Prepaids
      and other current assets
            
            
            72,049
            
            
            
            157,786Total
      current assets
            
            
            866,052
            
            
            
            1,207,606Property
      and equipment:Equipment
      and leaseholds
            
            
            2,168,787
            
            
            
            2,168,498Accumulated
      depreciation and amortization
            
            
            (2,163,975
            )
            
            
            (2,156,805
            )Net
      property and equipment
            
            
            4,812
            
            
            
            11,693Other
      assets:Deposits
            
            
            8,281
            
            
            
            8,281Total
      other assets
            
            
            8,281
            
            
            
            8,281Total
      assets
            
            $
            879,145
            
            
            $
            1,227,580Liabilities
      and Stockholders’ EquityCurrent
      liabilities:Accounts
      payable
            
            $
            171,872
            
            
            $
            119,866Notes
      payable
            
            
            535,000
            
            
            
            -Deferred
      revenues
            
            
            250,000
            
            
            
            301,399Accrued
      collaboration costs
            
            
            387,500
            
            
            
            -Accrued
      consultant fees
            
            
            81,500
            
            
            
            4,500Accrued
      vacation wages
            
            
            10,514
            
            
            
            28,703Accrued
      401k match
            
            
            -
            
            
            
            38,550Accrued
      interest
            
            
            64,060
            
            
            
            -Other
      accrued expenses
            
            
            18,019
            
            
            
            26,432Total
      current liabilities
            
            
            1,518,465
            
            
            
            519,450Long
      term liabilities:Notes
      payable
            
            
            -
            
            
            
            500,000Total
      long term liabilities
            
            
            -
            
            
            
            500,000Stockholders'
      equity:Preferred
      stock, par value $0.0025: 5,000,000 shares authorized; none issued and
      outstanding
            
            
            -
            
            
            
            -Common
      stock, par value $0.0025; 100,000,000 shares authorized;
              4,389,000
      shares issued and outstanding
            
            
            325,665
            
            
            
            325,547Treasury
      stock, 777 shares, at cost
            
            
            (10,614
            )
            
            
            (10,614
            )Additional
      paid-in capital
            
            
            50,416,754
            
            
            
            50,156,580Deficit
      accumulated during the development stage
            
            
            (51,371,125
            )
            
            
            (50,263,383
            )Total
      stockholders' equity/(deficit)
            
            
            (639,320
            )
            
            
            208,130Total
      liabilities and stockholders' equity
            
            $
            879,145
            
            
            $
            1,227,580See
      accompanying notes to consolidated financial statements.








APPLIED
NEUROSOLUTIONS, INC.


(a
development stage company)




CONSOLIDATED
STATEMENTS OF OPERATIONS


Year Ended December 31,
            
            
            Period
      from March 14, 1992 (inception) to December 31,2009
            
            
            2008
            
            
            2009(unaudited)Research
      agreement revenues
            
            $
            -
            
            
            $
            4,800
            
            
            $
            1,707,500Collaboration
      revenues
            
            
            1,551,399
            
            
            
            833,333
            
            
            
            3,249,999Grant
      revenues
            
            
            -
            
            
            
            -
            
            
            
            669,022Total
      revenues
            
            
            1,551,399
            
            
            
            838,133
            
            
            
            5,626,521Operating
      expenses:Research
      and development...............
            
            
            1,319,874
            
            
            
            1,471,528
            
            
            
            33,832,070General
      and administrative
            
            
            1,279,011
            
            
            
            1,642,012
            
            
            
            19,375,363Loss
      on impairment of intangible assets
            
            
            -
            
            
            
            -
            
            
            
            411,016Loss
      on writedown of leasehold improvements
            
            
            -
            
            
            
            -
            
            
            
            1,406,057Total
      operating expenses
            
            
            2,598,885
            
            
            
            3,113,540
            
            
            
            55,024,506Operating
      loss
            
            
            (1,047,486
            )
            
            
            (2,275,407
            )
            
            
            (49,397,985
            )Other
      (income) expense:Interest
      expense
            
            
            64,060
            
            
            
            -
            
            
            
            780,404Interest
      income
            
            
            (3,804
            )
            
            
            (43,039
            )
            
            
            (925,358
            )Amortization
      of debt discount
            
            
            -
            
            
            
            -
            
            
            
            272,837Beneficial
      conversion of debt to equity
            
            
            -
            
            
            
            -
            
            
            
            274,072Inducement
      to convert debt to equity
            
            
            -
            
            
            
            -
            
            
            
            1,631,107Cost
      of fund raising activities
            
            
            -
            
            
            
            -
            
            
            
            62,582Loss
      on extinguishments of debt
            
            
            -
            
            
            
            -
            
            
            
            4,707,939Gain
      on derivative instrument, net
            
            
            -
            
            
            
            -
            
            
            
            (4,894,163
            )Net
      other expense
            
            
            -
            
            
            
            -
            
            
            
            63,720Total
      other (income) expense
            
            
            60,256
            
            
            
            (43,039
            )
            
            
            1,973,140Net
      loss
            
            
            (1,107,742
            )
            
            
            (2,232,368
            )
            
            
            (51,371,125
            )Less: Deemed dividend to
      common
              Stockholders..............................
            
            
            -
            
            
            
            -
            
            
            
            (391,312
            )Less:
      Fair value of induced preferred stock conversion.........................
            
            
            -
            
            
            
            -
            
            
            
            (1,866,620
            )Net
      loss attributable to common stockholders..............................
            
            $
            (1,107,742
            )
            
            $
            (2,232,368
            )
            
            $
            (53,629,057
            )Basic
      and diluted loss per common share:Net
      loss attributable to common stockholders per share, basic and
      diluted
            
            $
            (0.25
            )
            
            $
            (0.51
            )
            
            $
            (36.36
            )Weighted
      average shares outstanding
            
            
            4,366,000
            
            
            
            4,342,000
            
            
            
            1,475,000See
      accompanying notes to consolidated financial statements







APPLIED
NEUROSOLUTIONS, INC.




(a
development stage company)




CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY / (DEFICIT)




FOR
THE PERIOD FROM MARCH 14, 1992 (INCEPTION) TO DECEMBER 31, 2009








Shares
            
            
            Common
              Stock
            
            
            Treasury
              Stock
            
            
            Additional
              Paid
      in
              Capital
            
            
            Deficit
      Accumulated During the DevelopmentStage
            
            
            Total
              Stockholders’
              Equity
              (Deficit)Issuance
      of Common Stock
            
            
            12,423
            
            
            $
            932
            
            
            $
            -
            
            
            $
            (332
            )
            
            $
            -
            
            
            $
            600Net
      loss
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            (922,746
            )
            
            
            (922,746
            )Balance
      at December 31, 1992
            
            
            12,423
            
            
            
            932
            
            
            
            -
            
            
            
            (332
            )
            
            
            (922,746
            )
            
            
            (922,146
            )Issuance
      of Common Stock
            
            
            14,494
            
            
            
            1,087
            
            
            
            -
            
            
            
            (387
            )
            
            
            -
            
            
            
            700Issuance
      of Preferred Stock, subsequently converted to Common Stock
            
            
            5,532
            
            
            
            415
            
            
            
            -
            
            
            
            1,201,750
            
            
            
            -
            
            
            
            1,202,165Issuance
      of Preferred Stock, subsequently converted to Common Stock
            
            
            25,403
            
            
            
            1,905
            
            
            
            -
            
            
            
            5,640,172
            
            
            
            -
            
            
            
            5,642,077Issuance
      of Common Stock upon conversion of note and accrued
    interest
            
            
            12,278
            
            
            
            921
            
            
            
            -
            
            
            
            2,964,005
            
            
            
            -
            
            
            
            2,964,926Net
      loss
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            (4,875,845
            )
            
            
            (4,875,845
            )Balance
      at December 31, 1993
            
            
            70,130
            
            
            
            5,260
            
            
            
            -
            
            
            
            9,805,208
            
            
            
            (5,798,591
            )
            
            
            4,011,877Issuance
      of Preferred Stock, subsequently converted to Common Stock
            
            
            17,768
            
            
            
            1,333
            
            
            
            -
            
            
            
            4,006,404
            
            
            
            -
            
            
            
            4,007,737Retirement
      of Common Stock
            
            
            (63
            )
            
            
            (5
            )
            
            
            -
            
            
            
            (13,663
            )
            
            
            -
            
            
            
            (13,668
            )Net
      loss
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            (6,154,275
            )
            
            
            (6,154,275
            )Balance
      at December 31, 1994
            
            
            87,835
            
            
            
            6,588
            
            
            
            -
            
            
            
            13,797,949
            
            
            
            (11,952,866
            )
            
            
            1,851,671Issuance
      of Preferred Stock, subsequently converted to Common Stock
            
            
            16,461
            
            
            
            1,235
            
            
            
            -
            
            
            
            748,765
            
            
            
            -
            
            
            
            750,000Issuance
      of Preferred Stock upon conversion of bridge loan and accrued interest,
      subsequently converted to Common Stock
            
            
            22,973
            
            
            
            1,723
            
            
            
            -
            
            
            
            1,005,840
            
            
            
            -
            
            
            
            1,007,563Net
      loss
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            (2,191,159
            )
            
            
            (2,191,159
            )Balance
      at December 31, 1995
            
            
            127,269
            
            
            
            9,546
            
            
            
            -
            
            
            
            15,552,554
            
            
            
            (14,144,025
            )
            
            
            1,418,075Issuance
      of Preferred Stock, subsequently converted to Common Stock
            
            
            165,239
            
            
            
            12,393
            
            
            
            -
            
            
            
            6,864,881
            
            
            
            -
            
            
            
            6,877,274Issuance
      of Common Stock
            
            
            1,061
            
            
            
            80
            
            
            
            -
            
            
            
            96,524
            
            
            
            -
            
            
            
            96,604Net
      loss
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            (2,591,939
            )
            
            
            (2,591,939
            )Balance
      at December 31, 1996
            
            
            293,569
            
            
            
            22,019
            
            
            
            -
            
            
            
            22,513,959
            
            
            
            (16,735,964
            )
            
            
            5,800,014Issuance
      of Common Stock in connection with acquisition of intangible
      assets
            
            
            4,390
            
            
            
            329
            
            
            
            -
            
            
            
            399,671
            
            
            
            -
            
            
            
            400,000Net
      loss
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            (2,040,092
            )
            
            
            (2,040,092
            )Balance
      at December 31, 1997
            
            
            297,959
            
            
            
            22,348
            
            
            
            -
            
            
            
            22,913,630
            
            
            
            (18,776,056
            )
            
            
            4,159,922Net
      loss
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            (2,549,920
            )
            
            
            (2,549,920
            )Balance
      at December 31, 1998
            
            
            297,959
            
            
            
            22,348
            
            
            
            -
            
            
            
            22,913,630
            
            
            
            (21,325,976
            )
            
            
            1,610,002Net
      loss
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            (1,692,356
            )
            
            
            (1,692,356
            )Balance
      at December 31, 1999
            
            
            297,959
            
            
            
            22,348
            
            
            
            -
            
            
            
            22,913,630
            
            
            
            (23,018,332
            )
            
            
            (82,354
            )Issuance
      of Preferred Stock, subsequently converted to Common Stock
            
            
            48,884
            
            
            
            3,666
            
            
            
            -
            
            
            
            983,614
            
            
            
            -
            
            
            
            987,280Issuance
      of warrants to purchase shares of Common Stock
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            83,406
            
            
            
            -
            
            
            
            83,406











Shares
            
            
            Common
              Stock
            
            
            Treasury
              Stock
            
            
            Additional
              Paid
      in
              Capital
            
            
            Deficit
      Accumulated During the DevelopmentStage
            
            
            Total
              Stockholders’
              Equity
              (Deficit)Extension
      of warrants to purchase shares of Common Stock
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            154,685
            
            
            
            -
            
            
            
            154,685Stock
      options granted to non-employees
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            315,976
            
            
            
            -
            
            
            
            315,976Net
      loss
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            (2,395,538
            )
            
            
            (2,395,538
            )Balance
      at December 31, 2000
            
            
            346,843
            
            
            
            26,014
            
            
            
            -
            
            
            
            24,451,311
            
            
            
            (25,413,870
            )
            
            
            (936,545
            )Issuance
      of Common Stock upon conversion of bridge loans/accrd. int
            
            
            149,155
            
            
            
            11,185
            
            
            
            -
            
            
            
            2,027,696
            
            
            
            -
            
            
            
            2,038,881Issuance
      of Common Stock
            
            
            19,358
            
            
            
            1,452
            
            
            
            -
            
            
            
            211,048
            
            
            
            -
            
            
            
            212,500Stock
      options granted to non-employees
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            77,344
            
            
            
            -
            
            
            
            77,344Issuance
      of warrants to purchase shares of Common Stock
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            27,367
            
            
            
            -
            
            
            
            27,367Options
      reissued to adjust exercise term
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            64,033
            
            
            
            -
            
            
            
            64,033Beneficial
      conversion feature of convertible debt
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            229,799
            
            
            
            -
            
            
            
            229,799Induced
      conversion of convertible debt
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            1,631,107
            
            
            
            -
            
            
            
            1,631,107Net
      loss
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            (4,146,913
            )
            
            
            (4,146,913
            )Balance
      at December 31, 2001
            
            
            515,356
            
            
            
            38,651
            
            
            
            -
            
            
            
            28,719,705
            
            
            
            (29,560,783
            )
            
            
            (802,427
            )Issuance
      of Common Stock upon conversion of bridge loans, accrued interest, other
      payables and as payment for services
            
            
            240,066
            
            
            
            18,005
            
            
            
            -
            
            
            
            1,792,878
            
            
            
            -
            
            
            
            1,810,883Issuance
      of Common Stock upon conversion of warrants
            
            
            5,229
            
            
            
            392
            
            
            
            -
            
            
            
            35,536
            
            
            
            -
            
            
            
            35,928Stock
      options granted to non-employees
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            6,136
            
            
            
            -
            
            
            
            6,136Repurchase
      of Common Stock
            
            
            (777
            )
            
            
            (58
            )
            
            
            (10,614
            )
            
            
            58
            
            
            
            -
            
            
            
            (10,614
            )Merger
      between the Company and Molecular Geriatrics Corporation
            
            
            830,172
            
            
            
            62,263
            
            
            
            -
            
            
            
            (62,263
            )
            
            
            -
            
            
            
            -Issuance
      of warrants to purchase shares of Common Stock
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            159,934
            
            
            
            -
            
            
            
            159,934Net
      loss
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            (2,929,955
            )
            
            
            (2,929,955
            )Balance
      at December 31, 2002
            
            
            1,590,046
            
            
            
            119,253
            
            
            
            (10,614
            )
            
            
            30,651,984
            
            
            
            (32,490,738
            )
            
            
            (1,730,115
            )Variable
      accounting for stock options
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            604,100
            
            
            
            -
            
            
            
            604,100Stock
      options granted to non-employees..
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            80,975
            
            
            
            -
            
            
            
            80,975Issuance
      of warrants to purchase shares of common stock..............................
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            193,130
            
            
            
            -
            
            
            
            193,130Net
      loss.........................................
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            (3,301,420
            )
            
            
            (3,301,420
            )Balance
      at December 31, 2003
            
            
            1,590,046
            
            
            
            119,253
            
            
            
            (10,614
            )
            
            
            31,530,189
            
            
            
            (35,792,158
            )
            
            
            (4,153,330
            )Issuance
      of units in private placement
            
            
            1,066,667
            
            
            
            80,000
            
            
            
            -
            
            
            
            1,483,066
            
            
            
            -
            
            
            
            1,563,066Issuance
      of placement agent warrants
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            875,407
            
            
            
            -
            
            
            
            875,407Issuance
      of units upon conversion of bridge loans
            
            
            348,024
            
            
            
            26,102
            
            
            
            -
            
            
            
            7,292,016
            
            
            
            -
            
            
            
            7,318,118Issuance
      of common stock for services
            
            
            6,667
            
            
            
            500
            
            
            
            -
            
            
            
            64,500
            
            
            
            -
            
            
            
            65,000Issuance
      of units for services
            
            
            13,334
            
            
            
            1,000
            
            
            
            -
            
            
            
            268,426
            
            
            
            -
            
            
            
            269,426Issuance
      of warrants to purchase shares of common stock
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            124,775
            
            
            
            -
            
            
            
            124,775Variable
      accounting for stock options
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            1,535
            
            
            
            -
            
            
            
            1,535Net
      loss
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            (2,800,526
            )
            
            
            (2,800,526
            )Balance
      at December 31, 2004
            
            
            3,024,738
            
            
            
            226,855
            
            
            
            (10,614
            )
            
            
            41,639,914
            
            
            
            (38,592,684
            )
            
            
            3,263,471Issuance
      of stock upon exercise of warrants.....................................
            
            
            125,192
            
            
            
            9,389
            
            
            
            -
            
            
            
            667,745
            
            
            
            -
            
            
            
            677,134











Shares
            
            
            Common
              Stock
            
            
            Treasury
              Stock
            
            
            Additional
              Paid
      in
              Capital
            
            
            Deficit
      Accumulated During the DevelopmentStage
            
            
            Total
              Stockholders’
              Equity
              (Deficit)Issuance
      of stock options to purchase shares of common stock..................
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            77,057
            
            
            
            -
            
            
            
            77,057Variable
      accounting for stock options......
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            219,952
            
            
            
            -
            
            
            
            219,952Net
      loss..........................................
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            (2,620,641
            )
            
            
            (2,620,641
            )Balance
      at December 31, 2005
            
            
            3,149,930
            
            
            
            236,244
            
            
            
            (10,614
            )
            
            
            42,604,668
            
            
            
            (41,213,325
            )
            
            
            1,616,973Issuance
      of stock upon conversion of warrants
            
            
            67,140
            
            
            
            5,036
            
            
            
            -
            
            
            
            438,419
            
            
            
            -
            
            
            
            443,455Issuance
      of stock upon conversion of stock options
            
            
            17,007
            
            
            
            1,275
            
            
            
            -
            
            
            
            75,256
            
            
            
            -
            
            
            
            76,531Issuance
      of stock
            
            
            46,264
            
            
            
            3,470
            
            
            
            -
            
            
            
            559,054
            
            
            
            -
            
            
            
            562,524Non
      cash compensation for options FAS123R
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            720,322
            
            
            
            -
            
            
            
            720,322Issuance
      of warrants to purchase shares of common stock
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            200,866
            
            
            
            -
            
            
            
            200,866Non
      cash unrecognized compensation for options granted and
      cancelled
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            197,625
            
            
            
            -
            
            
            
            197,625Net
      loss
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            (4,289,327
            )
            
            
            (4,289,327
            )Balance
      at December 31, 2006
            
            
            3,280,341
            
            
            
            246,025
            
            
            
            (10,614
            )
            
            
            44,796,210
            
            
            
            (45,502,652
            )
            
            
            (471,031
            )Issuance
      of stock upon conversion of warrants
            
            
            338,911
            
            
            
            25,420
            
            
            
            -
            
            
            
            1,672,119
            
            
            
            -
            
            
            
            1,697,539Issuance
      of stock
            
            
            721,354
            
            
            
            54,102
            
            
            
            -
            
            
            
            2,845,898
            
            
            
            -
            
            
            
            2,900,000Non
      cash compensation for options FAS123R
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            496,848
            
            
            
            -
            
            
            
            496,848Issuance
      of warrants to purchase shares of common stock
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            39,491
            
            
            
            -
            
            
            
            39,491Net
      loss
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            (2,528,363
            )
            
            
            (2,528,363
            )Balance
      at December 31, 2007
            
            
            4,340,606
            
            
            
            325,547
            
            
            
            (10,614
            )
            
            
            49,850,566
            
            
            
            (48,031,015
            )
            
            
            2,134,484Non
      cash compensation for options FAS123R
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            301,514
            
            
            
            -
            
            
            
            301,514Issuance
      of warrants to purchase shares of common stock
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            4,500
            
            
            
            -
            
            
            
            4,500Net
      loss
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            (2,232,368
            )
            
            
            (2,232,368
            )Balance
      at December 31, 2008
            
            
            4,340,606
            
            
            
            325,547
            
            
            
            (10,614
            )
            
            
            50,156,580
            
            
            
            (50,263,383
            )
            
            
            208,130Non
      cash compensation for options FAS123R
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            260,292
            
            
            
            -
            
            
            
            260,292Issuance
      of stock
            
            
            48,394
            
            
            
            118
            
            
            
            -
            
            
            
            (118
            )
            
            
            -
            
            
            
            -Net
      loss
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            (1,107,742
            )
            
            
            (1,107,742
            )Balance
      at December 31, 2009
            
            
            4,389,000
            
            
            $
            325,665
            
            
            $
            (10,614
            )
            
            $
            50,416,754
            
            
            $
            (51,371,125
            )
            
            $
            (639,320
            )








See
accompanying notes to consolidated financial statements







APPLIED
NEUROSOLUTIONS, INC.




(a
development stage company)




CONSOLIDATED
STATEMENTS OF CASH FLOWS





Year
      Ended December 31,
            
            
            Period
      from March 14, 1992 (inception) to December 31,2009
            
            
            2008
            
            
            2009(unaudited)Cash
      flows from operating activitiesNet loss
            
            $
            (1,107,742
            )
            
            $
            (2,232,368
            )
            
            $
            (51,371,125
            )Adjustments to reconcile net
      loss to net cash
              used in operating
      activities:Depreciation and
      amortization
            
            
            8,893
            
            
            
            16,484
            
            
            
            2,650,791Non-cash expense for equity
      compensation
            
            
            -
            
            
            
            -
            
            
            
            2,379,241Non-cash expense for equity
      compensation
              to
      employees and directors
            
            
            260,292
            
            
            
            306,014
            
            
            
            3,149,974Non-cash
      interest expense
            
            
            64,060
            
            
            
            -
            
            
            
            398,972Amortization of deferred
      financing costscosts
            
            
            -
            
            
            
            -
            
            
            
            111,000Non-cash expense for
      beneficial conversion
              of debt
            
            
            -
            
            
            
            -
            
            
            
            274,072Non cash expense for induced
      conversion
              of debt
            
            
            -
            
            
            
            -
            
            
            
            1,631,107Non-cash expense for loss
      on
              extinguishment of debt
            
            
            -
            
            
            
            -
            
            
            
            4,707,939Non-cash income for gain on
      derivative
              instrument, net
            
            
            -
            
            
            
            -
            
            
            
            (4,894,163
            )Amortization of intangible
      assets
            
            
            -
            
            
            
            -
            
            
            
            328,812Loss on writedown of
      leasehold
              improvements
            
            
            -
            
            
            
            -
            
            
            
            1,406,057Loss on impairment of
      intangible assets
            
            
            -
            
            
            
            -
            
            
            
            411,016Gain on sale of equipment
            
            
            263
            
            
            
            -
            
            
            
            13Fundraising expense
            
            
            -
            
            
            
            -
            
            
            
            62,582Changes in assets and
      liabilities:Accounts receivable
            
            
            4,800
            
            
            
            (4,800
            )
            
            
            203,290Prepaids and other assets
            
            
            85,737
            
            
            
            (63,687
            )
            
            
            (65,612
            )Accounts payable
            
            
            52,006
            
            
            
            45,696
            
            
            
            268,476Deferred revenues
            
            
            (51,399
            )
            
            
            (333,333
            )
            
            
            250,000Accrued wages
            
            
            -
            
            
            
            (120,000
            )
            
            
            -Accrued collaborator
      costs
            
            
            387,500
            
            
            
            -
            
            
            
            387,500Accrued consultant fees
            
            
            77,000
            
            
            
            (300
            )
            
            
            106,500Accrued vacation wages
            
            
            (18,189
            )
            
            
            (10,357
            )
            
            
            10,514Other accrued expenses
            
            
            (46,963
            )
            
            
            (17,487
            )
            
            
            141,168Net
      cash used in operating activities
            
            
            (283,742
            )
            
            
            (2,414,138
            )
            
            
            (37,451,876
            )Cash
      flows from investing activitiesAcquisition of investment
      securities
            
            
            -
            
            
            
            -
            
            
            
            (9,138,407
            )Redemption of investment
      securities
            
            
            -
            
            
            
            -
            
            
            
            9,138,407Acquisition of intangible
      assets
            
            
            -
            
            
            
            -
            
            
            
            (339,829
            )Acquisition of equipment
      and
              leasehold improvements
            
            
            (2,275
            )
            
            
            (983
            )
            
            
            (4,047,786
            )Net cash used in investing
      activitiesActivities
            
            
            (2,275
            )
            
            
            (983
            )
            
            
            (4,387,615
            )








Year Ended December 31,
            
            
            Period
      from March 14, 1992 (inception) to December 31,2009
            
            
            2008
            
            
            2009Cash
      flows from financing activities
            
            
            
            
            
            
            
            (unaudited)Proceeds
      from issuance of Preferred Stock
            
            
            -
            
            
            
            -
            
            
            
            12,193,559Proceeds
      from issuance of units, net of issuance costs
            
            
            -
            
            
            
            -
            
            
            
            22,433,555Proceeds
      from exercise of warrants
            
            
            -
            
            
            
            -
            
            
            
            2,818,128Proceeds
      from exercise of options
            
            
            -
            
            
            
            -
            
            
            
            76,531Proceeds
      from issuance of debt
            
            
            35,000
            
            
            
            500,000
            
            
            
            535,000Deferred
      financing costs incurred
            
            
            -
            
            
            
            -
            
            
            
            (111,000
            )Advances
      from director and shareholders
            
            
            -
            
            
            
            -
            
            
            
            120,000Principal
      payments under capital lease
            
            
            -
            
            
            
            -
            
            
            
            (11,766
            )Proceeds
      from issuance of promissory loans payable
            
            
            -
            
            
            
            -
            
            
            
            4,438,491Payments
      to shareholders for registration statement penalties
            
            
            -
            
            
            
            -
            
            
            
            (84,000
            )Payments
      to repurchase Common Stock
            
            
            -
            
            
            
            -
            
            
            
            (10,614
            )Payments
      received for employee stock purchase notes receivable
            
            
            -
            
            
            
            -
            
            
            
            235,610Net
      cash provided by financing activities
            
            
            35,000
            
            
            
            500,000
            
            
            
            42,633,494Net
      increase (decrease) in cash
            
            
            (251,017
            )
            
            
            (1,915,121
            )
            
            
            794,003Cash
      at beginning of period
            
            
            1,045,020
            
            
            
            2,960,141
            
            
            
            -Cash
      at end of period
            
            $
            794,003
            
            
            $
            1,045,020
            
            
            $
            794,003Supplemental
      cash flow informationCash
      paid for interest
            
            $
            -
            
            
            $
            -
            
            
            $
            72,090Supplemental
      disclosure of non-cash investing and financing activitiesIssuance
      of stock for prior services
            
            $
            -
            
            
            $
            -
            
            
            $
            4,149,521Intangible
      assets acquired in exchange for stock
            
            $
            -
            
            
            $
            -
            
            
            $
            400,000Equipment
      acquired for account payable
            
            $
            -
            
            
            $
            -
            
            
            $
            31,649Equipment
      acquired under capital lease
            
            $
            -
            
            
            $
            -
            
            
            $
            11,766Issuance
      of stock for promissory loans payable
            
            $
            -
            
            
            $
            -
            
            
            $
            2,473,991Issuance
      of stock for accrued interest on promissory loans payable
            
            $
            -
            
            
            $
            -
            
            
            $
            136,188See
      accompanying notes to consolidated financial statements.












APPLIED
NEUROSOLUTIONS, INC.




(a
development stage company)




NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS









Note 1 – Organization and
Summary of Significant Accounting Policies





(a)           Organization and Basis of
Presentation





Applied NeuroSolutions, Inc. (“APNS” or
the “Company”), is a development stage biopharmaceutical company primarily
engaged in the research and development of novel therapeutic targets for the
treatment of Alzheimer's disease (“AD”) and diagnostics to detect
AD.





Prior to 2004, the Company had two
wholly-owned operating subsidiaries.  One of the wholly-owned
operating subsidiaries was Molecular Geriatrics Corporation (“MGC”), a
development stage biopharmaceutical company incorporated in November 1991, with
operations commencing in March 1992, to develop diagnostics to detect, and
therapeutics to treat, Alzheimer’s disease.





The other wholly-owned operating
subsidiary was Hemoxymed Europe, SAS, a development stage biopharmaceutical
company incorporated in February 1995 to develop therapies aimed at improving
tissue oxygenation by increasing oxygen release from hemoglobin to provide
therapeutic value to patients with serious, unmet, medical needs.  We
are not currently funding the development of this technology.  The
Company dissolved these two subsidiaries, and transferred all of their assets to
APNS in 2004.





On September 10, 2002, Hemoxymed, Inc.
and Molecular Geriatrics Corporation (“MGC”) established a strategic alliance
through the closing of a merger (the “Merger”).  The Merger Agreement
provided that the management team and Board of Directors of MGC took over
control of the merged company.  The transaction was tax-free to the
shareholders of both companies.  In October 2003, the Company changed
its name to Applied NeuroSolutions, Inc.





This transaction has been accounted for
as a reverse merger.  For financial reporting purposes, MGC is
continuing as the primary operating entity under the Company’s name, and its
historical financial statements have replaced those of the
Company.  Thus, all financial information prior to the Merger date is
the financial information of MGC only.





The consolidated financial statements
have been prepared in accordance with the applicable standards for development
stage companies, which require development stage companies to employ the same
accounting principles as operating companies.





The Company is subject to risks and
uncertainties common to small cap biotech companies, including competition from
larger, well capitalized entities, patent protection issues, availability of
funding and government regulations.





(b)           Principles of
Consolidation





Prior to 2004, the consolidated
financial statements include the accounts of the Company and its subsidiaries,
MGC and Hemoxymed Europe, SAS.  All significant intercompany balances
and transactions have been eliminated.





(c)           Going Concern





The Company has experienced losses
since inception in addition to incurring cash outflows from operating activities
for the last two years as well as since inception.  The Company
expects to incur substantial additional research and development costs and
future losses prior to reaching profitability.  These matters have
raised substantial doubt about the Company's ability to continue as a going
concern for a reasonable period of time.  The Company's ability to
continue as a going concern is dependent on obtaining adequate funding and
ultimately





achieving
profitable operations.  In the opinion of management, the Company
anticipates cash balances as of December 31, 2009 will be sufficient to fund the
Company’s current level of operations into the second quarter of
2010.  The Company will need additional funding in the second quarter
of 2010 in order to continue its research, product development and
operations.  If additional funding is not obtained, the Company will
not be able to fund any of its programs, and the Company will possibly
discontinue all its product development and/or operations.  Management
is currently evaluating its options to maximize the value of the Company’s
diagnostic technology, including evaluating partnering and licensing
opportunities.  The Company intends to seek such additional funding
through private and/or public financing, through exercise of currently
outstanding stock options and warrants or through collaborative or other
arrangements with partners, however, there is no assurance that additional
funding will be available for the Company to finance its operations on
acceptable terms, or at all.  This would have a material adverse
effect on the Company’s operations and prospects.





(d)           Cash





The Company maintains cash at financial
institutions from time to time in excess of the Federal Depository Insurance
Corporation (“FDIC”) insured limit.





(e)           Revenue Recognition, Accounts
Receivable and Allowance for Doubtful Accounts





The Company generates revenues from
research agreements and collaborations, and in the past, the Company also
generated revenues from grants.  Revenue is recognized when
earned.  Grant revenues represent funds received from certain
government agencies for costs expended to further research on the subject of the
grant.  In accordance with current accounting literature, if revenue
arrangements contain multiple deliverables, the Company separates the
deliverables into separate accounting units if they meet all of the
following:  a) the delivered items have stand-alone value to the
customer; b) the fair value of any undelivered items can be reliably determined;
and c) if the arrangement includes a general right of return, delivery of the
undelivered items if probable and substantially controlled by the
seller.  Deliverables that do not meet these criteria are combined
with one or more other deliverables into one accounting unit.  Revenue
from each accounting unit is recognized based on the applicable accounting
literature.





Accounts receivable represent amounts
due, but not yet paid, from research agreements and
collaborations.   Accounts receivable are considered past due
when they are outstanding more than 30 days after the terms of the agreement.
The Company does not accrue interest on past due accounts
receivable.  Receivables are written off only after all collection
attempts have failed and are based on the specific circumstances of the
customer.  An allowance for doubtful accounts would be recorded if any
receivable was deemed to be potentially uncollectible.  No receivable
has been written off or been considered uncollectible during 2009 and
2008.  The allowance for doubtful accounts was $-0- at December 31,
2009 and 2008, respectively.





(f)           Equipment and Leasehold
Improvements





Equipment and leasehold improvements
are recorded at cost.  Depreciation of equipment is calculated using
accelerated methods over the assets’ useful lives, approximating five to seven
years.  Amortization of leasehold improvements is provided on the
straight-line method over the lesser of the asset’s useful life or the lease
term.





(g)           Research and
Development





All research and development costs are
expensed as incurred and include salaries of, and expenses related to, employees
and consultants who conduct research and development, funding for research and
development programs, funding for research related to license agreements, and
overhead costs.





(h)           Income Taxes





The Company’s deferred tax assets and
liabilities are recognized for the future tax consequences attributable to
differences between financial statement carrying amounts of existing assets and
liabilities and their respective tax bases, and operating loss and tax credit
carryforwards.  In assessing the realizability of the deferred tax
assets, management considers whether it is more likely than not that some
portion or all of the deferred tax assets





will
not be realized.  A valuation allowance is recorded for the portion of
the deferred tax assets that are not expected to be realized based on the levels
of historical taxable income and projections for future taxable income over the
periods in which the deferred tax assets are deductible.  At December
31, 2009, a valuation allowance has been established for the entire amount of
deferred tax assets.





It is the Company’s policy to provide
for uncertain tax positions and the related interest and penalties based upon
management's assessment of whether a tax benefit is more likely than not to be
sustained upon examination by tax authorities.  At December 31, 2009,
management believes there were not any unrecognized income tax benefits and/or
liabilities.





(i)           Stock Option
Plan





The
weighted average estimated fair value of the options granted in 2009 and 2008
was $0.70 and $2.71, respectively (adjusted for the Company’s 1-for-30 reverse
stock split in June 2009), based on the Black-Scholes valuation model using the
following assumptions:





2009
            
            
            2008Risk-free
      interest rate, average
            
            
            1.44
            %
            
            
            1.50
            %Dividend
            
            
            0.00
            %
            
            
            0.00
            %Expected
      volatility
            
            
            332.61
            %
            
            
            241.76
            %Expected
      life in years, average
            
            
            3
            
            
            
            2





From time to time, the Company has
issued equity awards to non-employees.  In these instances, the
Company recognizes expense related to these awards over the vesting or service
period of an amount equal to the estimated fair value of these awards at their
respective measurement dates (see Note 6).





(j)           Restricted
Shares





The holder of a restricted share award
is generally entitled at all times on and after the date of issuance of the
restricted shares to exercise the rights of a shareholder of the Company,
including the right to vote the shares and the right to receive dividends on the
shares. During 2009 the Company’s Board of Directors granted 153,846 restricted
shares to its previous CEO based on the terms of her employment.  The
Company’s Board of Directors did not grant any restricted shares in
2008.  The restricted shares are valued based on the closing
price on the date of grant and vest over a three-year period based on the
continuation of employment.  At August 31, 2009, 51,282 of the
restricted shares granted in 2009 were vested at the time of the employee’s
termination of employment.





(k)           Use of Estimates





Management of the Company has made a
number of estimates and assumptions relating to the reporting of assets and
liabilities and the disclosure of contingent assets and liabilities at the date
of the financial statements, and the reported amounts of revenues and expenses
during the reporting period, to prepare these financial statements in conformity
with accounting principles generally accepted in the United States of
America.  Actual results could differ from those
estimates.





(l)           Computation of Net Loss Attributable
to Common Stockholder per Share





Net loss attributable to common
stockholder per share is computed based upon the weighted average number of
common shares outstanding during the period as if a) all reverse stock splits
were in effect at the beginning of all periods presented and b) the exchange of
common shares in the merger between the Company and MGC was in effect at the
beginning of all periods presented.





For each period, net loss attributable
to common stockholder per share is computed based on the weighted average number
of common shares outstanding with potential equivalent shares from all stock
options, warrants and convertible investor bridge loans excluded from the
computation because their effect is anti-dilutive.  The
Company





had
625,683 stock options and 258,592 warrants outstanding to issue common stock at
December 31, 2009.  The Company had 647,684 stock options and
1,442,463 warrants outstanding to issue common stock at December 31,
2008.





(m)           Fair Value of Financial
Instruments





The Company’s financial instruments
include cash, accounts receivable, accounts payable, loans payable, and other
accrued expenses.  The carrying value of these financial instruments
approximates their fair values due to the nature and short-term maturity of
these instruments.





(n)           Recent Accounting
Pronouncements





In June 2009, the FASB issued
Accounting Standards Update 2009-01, “The FASB Accounting Standards
Codification and the Hierarchy of Generally Accepted Accounting
Principles”(“ASU 2009-01”).  ASU 2009-01 or the
FASB Accounting Standards Codification (“Codification”) will become the source
of authoritative U.S. generally accepted accounting principles (“GAAP”)
recognized by the FASB to be applied by nongovernmental entities.  On
the effective date of ASU 2009-01, the Codification will supersede all
then-existing non-SEC accounting and reporting standards.  All other
non-grandfathered non-SEC accounting literature not included in the Codification
will become non-authoritative.  ASU 2009-01 is effective for financial
statements issued for interim and annual periods ending after September 15,
2009.  The adoption of the standard did not have a material impact on
the Company’s consolidated balance sheets, statements of operations,
or cash flows.





Note 2 – Collaboration
Agreement with Eli Lilly and Company





In November 2006, the Company entered
into an agreement with Eli Lilly and Company (“Lilly”) to develop therapeutics
to treat AD.  Pursuant to the terms of the agreement, the Company
received $2 million in cash, including an equity investment of $500,000, from
Lilly, plus it will receive annual research and development support for the
duration of the collaboration agreement.  In addition, Lilly will,
based on the achievement of certain defined milestones, provide the Company over
time with up to $20 million in milestone payments for advancing the Company’s
proprietary target to a therapeutic compound.  The collaboration has
also made progress on other targets that are part of the collaboration that
could provide milestone payments to the Company over time of up to $10 million
for advancing each of these other targets to a therapeutic
compound.  There is no limit to the number of targets that the Company
could receive milestone payments from Lilly.  There are no assurances
that any milestones will be met.  Royalties are to be paid to the
Company for AD drug compounds brought to market that result from the
collaboration.  There is no limit on the number of drug compounds for
which royalty payments may be due to the Company.  Lilly received the
exclusive worldwide rights to the intellectual property related to the Company’s
expertise in understanding the molecular neuropathology of AD as it pertains to
the formation of neurofibrillary tangles.  Lilly will fund the vast
majority of all pre-clinical research and development and will fully finance the
clinical testing, manufacturing, sales and marketing of AD therapeutics
developed from the collaboration.  The Company recorded $1,000,000
received in 2006 as deferred revenues and amortized the deferral over 36 months
through November 2009.  Included in collaboration revenues in 2009 and
2008 is an amortization of these deferred revenues of $301,399 and $333,333,
respectively.  In addition, $66,173 of legal fees directly associated
with the agreement were included in prepaid assets and were amortized over 36
months through November 2009.





In December 2009, the
Company announced an increase in the scope of its agreement with
Lilly.  The Company received $750,000 as compensation for technology
provided to Lilly upon signing the amendment to the original agreement, which is
included in collaboration revenues in 2009.  The Company may receive
up to an additional $25.5 million based on achievement of identified milestones
in the additional agreement.  Royalties are to be paid to the Company
for AD drug compounds brought to market that result from the
collaborations.  Also included in collaboration revenues in 2009 and
2008 is $500,000 received as research and development support.





Note
3  -  Property and Equipment





Property and equipment consist of the
following:














December 31,2009
            
            
            December 31, 2008Equipment
            
            $
            2,072,408
            
            
            $
            2,072,119Equipment
      held under capital lease
            
            
            11,766
            
            
            
            11,766Leasehold
      improvements
            
            
            84,613
            
            
            
            84,6132,168,787
            
            
            
            2,168,498Less
      accumulated depreciation and
              Amortization
            
            
            (2,163,975
            )
            
            
            (2,156,805
            )$
            4,812
            
            
            $
            11,693





Depreciation and amortization expense
amounted to $8,893 and $16,484 for the years ended December 31, 2009 and 2008,
respectively.





Note
4  -  Warrants





The Company issued warrants to
investors in conjunction with funds raised in December 1995.  These
warrants had an original expiration date of December 2000.  During
2000, these warrants were extended until December 2001.  Compensation
expense related to this extension was $154,685 in 2000.  These
warrants expired, unexercised, in December 2001.





The Company issued warrants to
investors in conjunction with funds raised in August through November
2000.  Compensation expense related to the issuance of these warrants
was $83,406 in 2000.  These warrants were converted to shares of
Common Stock in the 2001 Recapitalization (see Note 5).





The Company issued warrants to
investors in conjunction with funds raised in February through December
2001.  Compensation expense related to the issuance of these warrants
was $27,367 in 2001.  The majority of these warrants were converted to
shares of Common Stock in the 2001 Recapitalization (see Note
5).  Total compensation expense of $351,811 was recognized upon the
conversion of all the warrants in 2002.





The Company, in September 2002, prior
to the Merger date, issued warrants to previous investors in the
Company.  The majority of these warrants expired, unexercised, in
September 2009.





The Company issued 26,668 warrants, in
September 2002, to an entity controlled by the two largest shareholders of
Hemoxymed (prior to the Merger), in lieu of
compensation.  Compensation expense related to the issuance of these
warrants was $159,934 in 2002.  These warrants have an exercise price
of $6.00 per share, and expire in September 2012.





The Company issued warrants to
consultants in September 2003, in lieu of compensation.  Compensation
expense related to the issuance of these warrants was $74,077 in
2003.  These warrants expired, unexercised, in September
2008.





The Company issued warrants to a board
member and a non-employee in September 2003, in lieu of compensation, for
fundraising.  Compensation expense related to the issuance of these
warrants was $119,053 in 2003.  These warrants expired, unexercised in
September 2008.





The Company issued warrants to
consultants in January 2004, in lieu of compensation, for investor relations and
business consulting services and included the value of such warrants, $42,705,
in general and administrative expenses for the year ended December 31,
2004.  These warrants expired, unexercised in September
2008.





The Company issued warrants to
consultants in February 2004, in lieu of compensation, for financial advisory
and business consulting services and included the value of such warrants,
$109,426, in general and administrative expenses for the year ended December 31,
2004.  These warrants expired, unexercised in February
2009.











The Company issued warrants to
investors in the February 2004 offering, to placement agents for the February
2004 offering and to bridge loan investors upon conversion of their bridge loans
upon closing the February 2004 offering.  Certain of these warrants
were exercised between 2005 and 2007, see below.  The remaining
warrants were never exercised, and expired, unexercised in February
2009.





The Company issued warrants to
consultants in November 2004, in lieu of compensation, for investor relations
and business consulting services and included the value of such warrants,
$44,160, in general and administrative expenses for the year ended December 31,
2004.  These warrants expired, unexercised in November
2009.





The Company issued warrants to
consultants in November 2004, in lieu of compensation, for financial advisory
and business consulting services and included the value of such warrants,
$37,910, in general and administrative expenses for the year ended December 31,
2004.  These warrants expired, unexercised in November
2009.





In 2005, 125,192 warrants were
exercised and 920 warrants were forfeited by warrant holders.  Net
proceeds of $677,134 were received by the Company (at an average exercise price
of $5.40 per warrant).





The Company issued 30,750 warrants to
bridge loan holders in July 2006.  These warrants have an exercise
price of $0.075 per share, and expire in July 2011.





In 2006, 67,140 warrants were exercised
and 50 warrants were forfeited by warrant holders.  Net proceeds of
$443,455 were received by the Company (at an average exercise price of $6.60 per
warrant).





The Company issued 10,000 warrants to a
consultant in May 2007, as part of compensation paid to the consultant, for
investor relations and business consulting services and included the value of
such warrants, $39,491, in general and administrative expenses for the year
ended December 31, 2007.  These warrants have an exercise price of
$9.15 per share, and expire in May 2012.





The Company issued 207,143 warrants to
the investor in the September 2007 offering.  These warrants have an
exercise price of $5.70 per share, and expire in September 2012.





In 2007, 338,911 warrants were
exercised.  Net proceeds of $1,697,539 were received by the Company
(at an average exercise price of $5.10 per warrant).





The Company issued 3,515 warrants to a
consultant in April 2008, as part of compensation paid to the consultant, for
business consulting services and included the value of such warrants, $4,500, in
general and administrative expenses for the year ended December 31,
2008.  These warrants have an exercise price of $2.55 per share, and
expire in April 2013.





As of December 31, 2009, the Company
has reserved 258,592 shares of Common Stock for the exercise and conversion of
the remaining outstanding warrants described above.





A summary of the status of, and changes
in, the Company’s warrants as of and for the years ended December 31, 2009 and
2008, is presented below for all warrants issued:











2009
            
            
            2008Warrants
            
            
            Weighted-
              Average-Exercise
              Price
            
            
            Warrants
            
            
            Weighted-
              Average-Exercise
              PriceOutstanding
      at beginningof
      year
            
            
            1,442,464
            
            
            $
            8.40
            
            
            
            1,480,616
            
            
            $
            8.10Granted
            
            
            -
            
            
            
            -
            
            
            
            3,515
            
            
            
            2.55Exercised
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -Forfeited
            
            
            1,183,872
            
            
            
            8.99
            
            
            
            41,667
            
            
            
            4.50Outstanding
      at endof
      year
            
            
            258,592
            
            
            $
            5.48
            
            
            
            1,442,464
            
            
            $
            8.40





The weighted-average remaining
contractual life of the warrants outstanding as of December 31, 2009 is 2.63
years.





Note
5  -  Stockholders' Equity





The stockholders' equity information
presented in these financial statements reflects the retroactive recognition of
the effects of the Merger (see Note 1), the two recapitalizations of the
Company's capital structure, the "1996 Recapitalization", which became effective
in March 1996 and the "2001 Recapitalization", which became effective in
November 2001, and the Company’s 1-for-30 reverse stock split in June
2009.  The 1996 Recapitalization consisted of (i) the conversion of
each share of outstanding Series A Convertible Preferred Stock and Series B
Convertible Preferred Stock of the Company into one share of Common Stock, (ii)
a 1.0-for-10.6 reverse split of the outstanding shares of Common Stock, and
(iii) a reduction in the number of authorized shares of Common Stock and
Preferred Stock from 50,000,000 to 20,000,000 and 35,000,000 to 15,000,000,
respectively.  The 2001 Recapitalization consisted of (i) the
conversion of each share of outstanding Series C Convertible Preferred Stock of
the Company into two shares of Common Stock, (ii) the conversion of each share
of outstanding Series D Convertible Preferred Stock of the Company into three
and one-third shares of Common Stock, (iii) the conversion of convertible debt
plus accrued interest into five shares of Common Stock for each $1.50 of
convertible debt, and (iv) an increase in the number of authorized shares of
Common Stock from 20,000,000 to 50,000,000 (See Note 11).  The
Company’s 1-for-30 reverse stock split in June 2009 consisted of (i) a
1.0-for-30.0 reverse split of the outstanding shares of Common Stock, and (ii) a
reduction in the number of authorized shares of Common Stock from 200,000,000 to
100,000,000.  The number of authorized shares of Preferred Stock did
not change.





Pursuant to the terms of the General
Corporation Law of the State of Delaware, the Company's Restated Certificate of
Incorporation and the Certificates of Designation of the Series C and Series D
Convertible Preferred Stock, the increase in authorized shares in the 2001
Recapitalization was approved by the consent of a majority of the aggregate
voting power of the holders of the outstanding Common Stock and the Series C and
Series D Convertible Preferred Stock.  The conversion of the Series C
and Series D Convertible Preferred Stock was approved by a majority of the
respective holders of such shares voting separately as a class.  The
conversion of the convertible debt was approved by the individual debt
holder.





In conjunction with the Merger, each
outstanding share of MGC Common Stock was exchanged for .658394 shares of APNS
Common Stock and each outstanding MGC warrant and stock option was exchanged for
..658394 APNS warrant and stock option.





In December 2002, the Board of
Directors approved an increase in the number of authorized shares from
50,000,000 to 205,000,000, consisting of 200,000,000 Common Shares and 5,000,000
Preferred Shares.  Shareholder approval for this increase was obtained
in 2003.  See Note 11 for an explanation of the Company’s authorized
shares.








In September 2008, the Company’s
shareholders approved an amendment to the Company’s certificate of incorporation
to effect a reverse stock split of the Company’s common stock at any time prior
to June 30, 2009 at a ratio between 1-for-20 and 1-for-30 as determined by the
Company’s Board of Directors and to decrease the Company’s authorized common
stock from 200 million shares to 100 million shares.  In June 2009,
the Board of Directors approved and consummated a 1-for-30 reverse stock
split.  All share amounts in the consolidated financial statements
have been retroactively restated to reflect the reverse stock split for all
periods presented.  In the Consolidated Statements of Stockholders’
Equity/(Deficit), the Company has elected to present each issuance of Preferred
Stock, which was subsequently converted to Common Stock, as Common Stock as of
the date of each issuance of Preferred Stock.





Original Issuances of Preferred
Stock





In July 1993, the Company issued 89,050
shares of Series A Convertible Preferred Stock (“Series A”).  These
shares were subsequently converted to 5,532 shares of Common Stock.





In September through December 1993, the
Company issued 408,967 shares of Series B Convertible Preferred Stock (“Series
B”).  These shares were subsequently converted to 25,403 shares of
Common Stock.





In March through May 1994, the Company
issued 286,047 shares of Series B.  These shares were subsequently
converted to 17,768 shares of Common Stock.





In December 1995, the Company issued
12,500 shares of Series C Convertible Preferred Stock (“Series
C”).  These shares were subsequently converted to 16,461 shares of
Common Stock.





In December 1995, the Company issued
17,446 shares of Series C.  These shares were subsequently converted
to 22,973 shares of Common Stock.





In March through July 1996, the Company
issued 125,485 shares of Series C.  These shares were subsequently
converted to 165,239 shares of Common Stock.





In January through May 2000, the
Company issued 22,274 shares of Series D Convertible Preferred Stock (“Series
D”).  These shares were subsequently converted to 48,884 shares of
Common Stock.





Current Issuances of Common
Stock





In November 2001, as part of the 2001
Recapitalization, $2,038,881 of convertible debt, including accrued interest,
was converted to 149,155 shares of Common Stock.





In January through June 2002, the
Company issued 128,223 shares of common stock through a private placement, and
upon conversion of bridge loans, plus accrued interest.





In June 2002, the Company issued
111,843 shares of Common Stock to Company officers, consultants and vendors in
exchange for a reduction of $750,000 of amounts due.





In June 2002, the Company issued 5,229
shares of Common Stock to certain warrant holders in exchange for the conversion
of 21,672 warrants.





In September 2002, the Company
repurchased 777 shares of Common Stock.





In September 2002, certain shareholders
of a predecessor of the Company were issued, in exchange for past services,
52,075 seven-year warrants exercisable at $0.003 to purchase shares of Common
Stock.





In September 2002, an entity controlled
by the two largest shareholders of the Company prior to the merger were issued,
in lieu of compensation, 26,667 five year warrants exercisable at $6.00 to
purchase shares of Common Stock.  Expense of $159,934 was included in
general and administrative expense for the issuance of these
warrants.








In September 2003, a director of the
Company and an advisor were issued, in lieu of compensation for fund raising
activities, 41,667 five-year warrants exercisable at $4.50 to purchase shares of
Common Stock.  Expense of $119,053 was included in general and
administrative expenses for the issuance of these warrants.





In September 2003, two entities were
issued, in lieu of compensation, 28,334 five-year warrants exercisable at $6.00
to purchase shares of Common Stock.  Expense of $74,077 was included
in general and administrative expenses for the issuance of these
warrants.





In February 2004, the Company completed
an $8,000,000 private placement (net proceeds of $7,354,054).  The
private placement included accredited institutional investors and accredited
individuals.  In conjunction with this financing, the Company issued
an aggregate of 1,066,667 units priced at $7.50 per unit to
investors.  Each unit consisted of one share of common stock of the
Company and a five-year warrant exercisable to purchase one share of common
stock of the Company at an exercise price of $9.00.  The warrants
issued to investors were immediately exercisable.





Pursuant to the terms of the
Registration Rights Agreement entered into in connection with the transaction,
within seven calendar days following the date that the Company filed its Annual
Report on Form 10-KSB, the Company was required to file, and did file, with the
Securities and Exchange Commission (the “SEC”) a registration statement under
the Securities Act of 1933, as amended, covering the resale of all of the common
stock purchased and the common stock underlying the warrants, including the
common stock underlying the placement agents’ warrants.





The Registration Rights Agreement
further provided that if a registration statement was not filed, or did not
become effective, within 150 days from the closing date of the private
placement, then in addition to any other rights the holders may have, the
Company would be required to pay each holder an amount in cash, as liquidated
damages, equal to 1.5% per month of the aggregate purchase price paid by such
holder in the private placement for the common stock and warrants then held,
prorated daily.  The registration statement was filed within the
allowed time, however it was declared effective July 28, 2004 under SEC File
Number 333-113821, resulting in the Company incurring certain liquidated damages
in accordance with the terms of the private placement.  Liquidating
damages of $84,000 were paid to the unit holders in the private placement in the
third quarter 2004.





In accordance with generally accepted
accounting principles at the time of the transaction, the fair value of the
warrants was accounted for as a liability, with an offsetting reduction to
additional paid-in capital at the closing date (February 6,
2004).  The warrant liability, net of the liquidated damages, was
reclassified to equity on July 28, 2004, when the registration statement became
effective.





The fair value of the warrants was
estimated using the Black-Scholes option-pricing model with the following
assumptions:  no dividends; risk-free interest rate of 3.20%; the
contractual life of five years and volatility of 75%.  The fair value
of the warrants was estimated to be $8,754,068 on the closing date of the
transaction.  The difference between the fair value of the warrants of
$8,754,068 and the gross proceeds from the offering was classified as a
non-operating expense in the Company’s statement of operations, and included in
“Gain on derivative instrument, net”.  The fair value of the warrants
was then re-measured at March 31, 2004, June 30, 2004 and July 28, 2004 (the
date the registration statement became effective) and estimated to be $3,105,837
at July 28, 2004, with the decrease in fair value since February 6, 2004 due to
the decrease in the market value of the Company’s common stock.  The
decrease in fair value of the warrants of $5,648,231 from the transaction date
to July 28, 2004 was recorded as non-operating income in the Company’s statement
of operations, and included in “Gain on derivative instrument,
net”.  The fair value of the warrants at July 28, 2004 was
reclassified to additional paid in capital as of July 28, 2004.





The Company used $315,783 of the
proceeds from the private placement to reimburse officers of the Company for
expenses, including compensation that was incurred but unpaid, as of January 31,
2004.





The Company paid the placement agent
and its sub-agents $560,000 in cash as fees for services performed in
conjunction with the private placement.  The Company also incurred
$85,946 in other legal and accounting fees.  The Company also issued a
five-year warrant to purchase 106,667 shares of common stock of the Company at
an exercise price of $9.00 per share to the placement agent and its sub-agents
in the private placement.  The warrants issued to the placement agent
were exercisable commencing on February 6, 2005.  The warrants that
had not







previously
been exercised, expired in February 2009.  The fair value of the
warrants was computed as $875,407 based on the Black-Scholes option-pricing
model with the following assumptions:  no dividends; risk-free
interest rate of 3.20%; the contractual life of five years and volatility of
75%.  The Company allocated $1,521,353 between issuance costs
offsetting the liability for common stock warrants and equity based on a
relative fair value allocation of the stock issued and warrants issued to the
unit holders.  As a result, the Company initially recorded $621,171 of
issuance costs as an offset to the liability for common stock warrants related
to these fund raising activities in the Company’s consolidated balance
sheet.  The Company further recorded $62,582 of amortization expenses
from these issue costs as “Costs of fund raising activities” in the statement of
operations for the year ended December 31, 2004.





The adjustments discussed above were
triggered by the terms of the Company’s agreements for the private placement it
completed in February 2004, specifically related to the potential penalties if
the Company did not timely register the common stock underlying the warrants
issued in the transaction.  The adjustments had no impact on the
Company’s working capital, liquidity, or business operations.





Concurrent with the closing of the
private placement, bridge investors, who had made loans to the Company over the
18 months prior to February 2004, agreed to convert the $2,610,179 of loans and
unpaid interest into units on substantially the same terms as the investors in
the private placement.  The conversion terms accepted by the bridge
investors were substantially different than the initial conversion terms of the
bridge loans.  As a result, the Company accounted for the change in
conversion terms as a substantial modification of terms in accordance with
generally accepted accounting principles at the time of the
transaction.  As a result, the Company recorded a $4,707,939 loss on
debt extinguishment in the three month period ended March 31, 2004 for the
difference between the carrying value of the bridge loans on the date the
conversion terms were modified ($2,610,179) and the fair value of the equity
issued under the new conversion terms ($7,318,118).  Upon conversion,
the Company issued the bridge investors 348,024 shares of common stock and
382,827 warrants to purchase shares of common stock on the same terms as the
unit holders.  The fair value of the common stock was computed as
$4,176,286 based on the closing price of the Company’s stock on February 6,
2004.  The fair value of the warrants was determined to be $3,141,832
using the Black-Scholes option-pricing model with the following
assumptions:  no dividends; risk-free interest rate of 3.20%; the
contractual life of five years and volatility of 75%.  Upon
conversion, the $7,318,118 adjusted value of the bridge loans was reclassified
as $26,102 of common stock and $7,292,016 of additional
paid-in-capital.





In February 2004, the Company issued
13,334 shares of common stock and 13,334 warrants to consultants, in lieu of
compensation, for financial advisory and business consulting services valued at
$269,426.  Consulting expense related to the issuance of the shares of
common stock was $160,000 in 2004 based on the closing price of the Company’s
stock on the date of issuance.  Expense related to the issuance of the
warrants of $109,426 was included in general and administrative
expenses.  These warrants had an exercise price of $9.00 per share,
and expired, unexercised in February 2009.





In February 2004, the Company issued
3,334 shares of common stock to a consultant, in lieu of compensation, for
financial advisory and business consulting services.  Expense of
$40,000 was included in general and administrative expenses.





In November 2004, the Company issued
3,333 shares of common stock to a consultant, in lieu of compensation, for
scientific consulting services.  Expense of $25,000 was included in
research and development expenses.





During 2005, The Company issued 125,192
shares of common stock to warrant holders upon exercise of
warrants.





In August 2006, the Company’s Board of
Directors granted 13,334 shares of restricted common stock to the Company’s
President and CEO under terms of her employment.  These restricted
shares were issued in 2007 and vest over a three-year period.  Expense
of $45,804 and $19,100 was included in general and administrative expense in
2007 and 2006, respectively.








In October 2006, the Company issued
9,062 shares of common stock to a consultant, as part of the compensation to the
consultant, for executive search services.  Expense of $62,524 was
included in general and administrative expenses.





In November 2006, the Company sold
37,202 shares of common stock to Eli Lilly and Company for $500,000 (see Note
2).





During 2006, the Company issued 67,140
shares of common stock to warrant holders upon exercise of
warrants.





During 2006, the Company issued 17,007
shares of common stock to option holders upon exercise of options.





In September 2007, the Company sold
690,476 shares of common stock, along with 207,143 warrants to purchase shares
of common stock) to an investor in the September 2007 Placement for
$2,900,000.





During 2007, the Company issued 338,911
shares of common stock to warrant holders upon exercise of
warrants.





In December 2007, the Company issued
17,544 shares of restricted common stock to the Company’s President and CEO
under terms of her employment.  These restricted shares vest over a
three-year period.  Expense of $20,761 was included in general and
administrative expense in 2007.





In August 2009, the Company issued
153,846 shares of restricted common stock to the Company’s President and CEO
under terms of her employment.  These restricted shares vest over a
three-year period.  Her employment terminated as of August 31, 2009
and 51,282 of these shares of restricted common stock were vested upon her
termination.  In addition, 5,847 shares of restricted common stock
issued in 2007 were not vested upon her termination.  The net shares
of restricted common stock issued in 2009 were 45,435, which resulted in expense
of $29,533 being included in general and administrative expense in
2009.





In the event of any liquidation,
dissolution or winding up of the affairs of the Company, either voluntary or
involuntary, the holders of Preferred Stock are entitled to receive a
liquidation preference, adjusted for combinations, consolidations, stock splits
or certain issuances of Common Stock.  After payment has been made to
the holders of Preferred Stock of the full amounts to which they shall be
entitled, the holders of the Common Stock shall be entitled to receive ratably,
on a per share basis, the remaining assets.  As of December 31, 2009,
no Preferred Stock is outstanding.  The Company has reserved 258,592
shares of Common Stock for the exercise and conversion warrants, and 625,683
shares of Common Stock for the exercise and conversion of stock
options.





Note
6  -  Stock Option Plan





The Company executed a 1-for-30 stock
split in June 2009.  The number of stock options and exercise prices
discussed in these financial statements reflect this reverse stock split and all
other Company recapitalizations as if they had occurred from the inception of
the Company.





As of December 31, 2002, the Board of
Directors approved the Hemoxymed, Inc. (now called Applied NeuroSolutions, Inc.)
Stock Option Plan.  This plan is identical to the MGC pre-merger plan
(discussed below), with an increase in the number of options in the plan to
400,000.  Shareholder approval was obtained in 2003.





In conjunction with the Merger in
September 2002, each outstanding MGC stock option was exchanged for .658394 APNS
stock options.





In April 2001, management issued
non-qualifying stock options to two former employees to replace the incentive
stock options previously granted.  All terms of these options remained
the same.  Compensation expense of $64,033 was recorded to reflect the
fair value of these options.











In April 2001, the Board of Directors
granted 439 options to a non-employee exercisable at $45.00 per share, which
vest monthly over a twenty-four month period.  Compensation expense of
$24,170 was recorded to reflect the fair value of these options.





In July 2001, the Board of Directors
granted 220 options to an employee exercisable at $45.00 per share, which vest
one-fourth per year beginning July 2002.  These options were forfeited
during 2002.





In November 2001, the Board of
Directors granted 68,364 options exercisable at $9.00 per share which vest
one-fourth immediately and one-fourth per year beginning November
2002.  Non-employees were granted 4,829 of these options, which were
vested immediately.  Compensation expense of $53,174 was recorded to
reflect the fair value of options issued to non-employees.





In June 2002, the Board of Directors
granted 14,472 options exercisable at $4.50 per share which vest one-fourth
immediately and one-fourth per year beginning in June
2003.  Non-employees were granted 1,115 of these
options.  Compensation expense of $6,136 was recorded to reflect the
fair value of options issued to non-employees.





In June 2002, the Board of Directors
approved adjusting the exercise price of 146,636 options to $4.50 per
share.  This changed the accounting treatment for these stock options
to variable accounting until they are exercised.  For the year ended
December 31, 2003, the Company recorded compensation expense under variable
accounting equal to $604,100 related to these modified options.  For
the year ended December 31, 2002, no compensation expense had been recorded
related to these modified options as the Company’s stock price was below $4.50
as of December 31, 2002.





In September 2003, the Board of
Directors granted 177,900 options exercisable at $4.50 per share which vest
one-fourth immediately and one-fourth per year beginning in September
2004.  Non-employees were granted 25,067 of these
options.  Compensation expense of $80,975 was recorded to reflect the
fair value of options issued to non-employees.





In November 2004, the Board of
Directors granted 4,000 options exercisable at $5.10 per share which vest
one-fourth immediately and one-fourth per year beginning in November
2005.





In April 2005, the Company granted
134,839 stock options to employees, officers, independent directors and a
consultant, of which 110,086 options were granted to executive officers and
directors, 18,086 options were granted to employees, and 6,667 options were
granted to a consultant.  Compensation expense of $31,870 was recorded
to reflect the fair value of options issued to the consultant.  In
addition, the Company granted 10,000 stock options to independent directors in
the second half of 2005.  The 120,086 stock options granted to
executive officers and independent directors in 2005 were not approved by the
Company’s stockholders at the Company’s Annual Stockholder Meeting on June 20,
2006 and were cancelled and not reissued.  Included in general and
administrative expense and research and development expense in the quarter ended
June 30, 2006 was a non-cash expense of $80,165 and $117,460, respectively, to
record unrecognized compensation costs on these options.





In January 2006, 3,135 options were
exercised at an average exercise price of $4.50 and 22,556 options with exercise
prices ranging from $4.50 to $159.00 expired, unexercised.  In May
2006, 1,427 options with an exercise price of $4.50 expired,
unexercised.





On June 20, 2006, at the Company’s
Annual Stockholder Meeting, the stockholders voted against increasing the
maximum allowable shares of common stock issuable under the Company’s 2003 stock
option plan from 400,000 shares to 666,667 shares and voted against ratification
of the 120,086 options granted to executive officers and independent directors
in 2005.  Thus, these 2005 stock options were cancelled and not
reissued, and consequently, became available for future grants under the
Company’s 2003 stock option plan.





On June 27, 2006, the Board of
Directors approved a grant of 20,000 stock options to independent directors or
the Company.





On June 27, 2006, the Board of
Directors also approved a grant of 133,334 stock options to the Company’s new
Chairman.  This option grant was not made under the Company’s 2003
stock option plan, but was made in consideration of the engagement of the new
Chairman.







On August
29, 2006, The Board of Directors approved a grant of 200,000 stock options to
the Company’s newly appointed President and CEO.  This option grant
was made pursuant to the terms of the new CEO’s employment and was not made
under the Company’s 2003 stock option plan.  The Board of Directors
also approved a grant to the Company’s new CEO of 13,334 restricted shares of
common stock, which grant was made (i) on the same day as the new CEO’s option
grants and (ii) pursuant to the terms of the new CEO’s employment.  In
addition, the Board of Directors approved a grant to the Company’s new CEO of
$100,000 of restricted shares of common stock on both the first and second
anniversaries of her employment (August 29, 2007 and 2008).





On September 7, 2006, the Board of
Directors approved a grant of 10,000 stock options to an outside director of the
Company.





On October 23, 2007, the Board of
Directors approved a grant of 10,000 stock options to a new outside director of
the Company.





During 2007, 5,896 stock options
expired, unexercised.





On December 7, 2007, the Company’s
Chairman stepped down, remaining as a Director, and offered to return to the
Company 44,445 unvested stock options.  These options were cancelled
and the underlying shares are available for future issuance by the
Company.





In March 2008, the Board of Directors
approved a compensation plan for independent Directors effective as of January
1, 2008.  As part of the compensation plan, each independent Director
will receive an annual stock option grant as of the first Board meeting of the
year, valued at $5,000, calculated using a Black-Scholes valuation on the date
of the grant.  The stock options will have an exercise price equal to
the closing price of the Company’s common stock on the day prior to the grant
and will vest on the first business day of January in the following
year.  On March 7, 2008, the Company’s four independent Directors each
received a grant of 3,907 stock options.  On October 30, 2008, a new
independent Director received a pro-rated grant of 669 stock
options.  On November 14, 2008, a new independent Director received a
pro-rated grant of 640 stock options.





During 2008, 10,661 stock options
expired, unexercised.





On February 24, 2009, the Company’s
four independent Directors each received a grant of 6,665 stock options under
the compensation plan for independent Directors discussed above.  Each
option grant was valued at $5,000, calculated using a Black-Scholes valuation on
the date of the grant.





On March
6, 2009, the Company entered into stock option exchange agreements with five
employees and the Company’s founding scientist.  In return for
exchanging 360,465 previously granted stock options with exercise prices ranging
from $4.50 to $8.55, the Company issued 120,155 new stock options, 1 new option
for every 3 options returned, with an exercise price of $1.485.  This
exercise price represented a 25% premium to the Company’s closing price on the
day prior to the exchange.  The vesting schedules and the expiration
dates of the new options are the same as the vesting schedules and expiration
dates of the returned options.  The stock option exchange was approved
by the Company’s Board of Directors.





On September 1, 2009, the Board of
Directors approved a grant of 203,993 stock options to the Company’s new
President and CEO.





During 2009, 12,348 stock options
expired, unexercised.





The Company calculates expected
volatility for stock options using historical volatility.  The
starting point for the historical period used is September 2002, the timing of
the Merger (see Note 1).  The Company currently estimates the
forfeiture rate for stock options to be minimal.





The risk-free rates for the expected
terms of the stock options and awards and the employee stock purchase plan is
based on the U.S. Treasury yield curve in effect at the time of the
grant.





As of December 31, 2009, the Company
had 332,801 outstanding stock options granted under its 2003 stock option plan
and had 292,882 outstanding stock options granted outside the 2003 stock option
plan.  As of





December
31, 2009 there was approximately $113,562 of total unrecognized non-cash
compensation costs related to the outstanding stock options, which is expected
to be recognized over a weighted-average period of 2.75 years.





As of December 31, 2009, 625,683
options were outstanding (395,032 were fully vested and exercisable) at prices
ranging from $0.70 to $45.00 per share.





A summary of the status of, and changes
in, the Company’s stock options as of and for the years ended December 31, 2009
and 2008, is presented below for all stock options issued to employees,
directors and non-employees:





2009
            
            
            2008Options
            
            
            Weighted-
              Average-Exercise
              Price
            
            
            Options
            
            
            Weighted-
              Average-Exercise
              PriceOutstanding
      at beginningof
      year
            
            
            647,688
            
            
            $
            5.70
            
            
            
            641,412
            
            
            $
            5.70Granted
            
            
            350,808
            
            
            
            1.00
            
            
            
            16,937
            
            
            
            3.00Exercised
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            
            -Forfeited
            
            
            372,813
            
            
            
            5.99
            
            
            
            10,661
            
            
            
            6.90Outstanding
      at endof
      year
            
            
            625,683
            
            
            $
            2.89
            
            
            
            647,688
            
            
            $
            5.70Options
      exercisable atend
      of year
            
            
            395,030
            
            
            $
            4.14
            
            
            
            584,640
            
            
            $
            5.70





The majority of outstanding stock
options at December 31, 2009 have an exercise price greater than the December
31, 2009 market price.The intrinsic value of options
outstanding and options exercisable at December 31, 2009 was $83,637 and $0,
respectively.  No options were exercised during 2009.  The
intrinsic value at December 31, 2009 of options expected to vest was
$83,637.





Stock Options as of December 31,
      2009Exercise
              Price
            
            
            Number
              Outstanding
      at
              December 31, 2009
            
            Weighted-Average
              Remaining
              Contractual Life
            
            Number
              Exercisable
      at
              December 31, 2009$
            0.700
            
            
            
            203,993
            
            9.7
      years
            
            
            -0-1.170
            
            
            
            26,660
            
            9.2
      years
            
            
            -0-1.200
            
            
            
            640
            
            8.9
      years
            
            
            6401.485
            
            
            
            118,077
            
            5.6
      years
            
            
            118,0771.530
            
            
            
            669
            
            8.8 years
            
            
            6693.000
            
            
            
            7,814
            
            8.3 years
            
            
            7,8144.500
            
            
            
            139,281
            
            3.6 years
            
            
            139,2815.100
            
            
            
            2,500
            
            4.8 years
            
            
            2,5005.700
            
            
            
            10,000
            
            7.8 years
            
            
            10,0006.000
            
            
            
            105,555
            
            6.5 years
            
            
            105,5558.250
            
            
            
            10,000
            
            6.7 years
            
            
            10,00045.000
            
            
            
            494
            
            1.2 years
            
            
            494625,683
            
            
            
            
            395,030











Note
7  -  Employee Savings Plan





The Company sponsors a defined
contribution benefit plan (the “Savings Plan”) which qualifies under Section
401(k) of the Internal Revenue Code.  The Savings Plan covers all
eligible employees who are at least eighteen years of age and have completed six
months of service with the Company.  Employee contributions to the
Savings Plan are based on percentages of employee compensation plus a
discretionary matching contribution by the Company.  Vesting in the
Company’s contributions is based on length of service over a five-year
period.  The Company amended the Savings Plan, effective January 1,
2001, to increase the Company match from 50% to 100% of the first 5% of an
employee’s deferral, subject to certain limitations.  In February
2009, the Company’s Board of Directors suspended the Company match for
2009.  Contributions by the Company for the years ended December 31,
2009 and 2008 were $0 and $36,654, respectively.





Note
8  -  Income Taxes





No Federal or state income taxes have
been provided for in the accompanying consolidated financial statements because
of net operating losses incurred to date and the establishment of a valuation
allowance equal to the amount of the Company's deferred tax
assets.  At December 31, 2009, the Company has net operating loss and
research and development credit carry-forwards for Federal income tax purposes
of approximately $32,000,000 and $820,000, respectively.  These
carry-forwards expire between 2010 and 2029.  In 2009, net operating
loss carry-forwards of $6,039,518 expired and research and development credit
carry-forwards of $208,148 expired.  Changes in the Company's
ownership may cause annual limitations on the amount of loss and credit
carry-forwards that can be utilized to offset income in the
future.  Net operating loss and research and development credit
carry-forwards, as of December 31, 2009, expiring over the next five years are
as follows:





Year
      Expiring
            
            Net
      Operating Loss
            
            
            Research
      and Development Credit2010
            
            $
            2,100,609
            
            
            $
            31,5222011
            
            
            2,003,368
            
            
            
            21,4542012
            
            
            2,398,264
            
            
            
            51,2372013
            
            
            
            
            
            
            53,7312014
            
            
            
            
            
            
            48,383Total
            
            $
            6,502,241
            
            
            $
            206,327





The net deferred tax assets as of
December 31, 2009 and 2008 are summarized as follows:





December 31, 2009
            
            
            December 31, 2008Deferred
      tax assets:Depreciation
            
            $
            125,000
            
            
            $
            150,000Net operating loss
      carry-forwards
            
            
            12,800,000
            
            
            
            14,900,000Tax credit
      carry-forwards
            
            
            820,000
            
            
            
            970,00013,745,000
            
            
            
            16,020,000Valuation
      allowance
            
            
            (13,745,000
            )
            
            
            (16,020,000
            )Net deferred income
      taxes
            
            $
            -
            
            
            $
            -





The net change in the valuation
allowance during 2009, after taking into account expiring net operating loss and
research and development credit carry-forwards, was a decrease of
$2,275,000.  The net change in the valuation allowance during 2008 was
a decrease of $1,075,000.














Note
9  -  Commitments and Contingencies





Operating
Lease


The Company operates out of a
laboratory and office facility in Vernon Hills, Illinois.  The
original lease term was for sixty-three months through May 14, 2002 and included
a renewal option for two additional five-year periods.  In May 2002,
the lease was extended for a five-year period, through May 14,
2007.  In April 2007, the lease was extended for a three-year period,
through May 14, 2010.





Future minimum lease payments as of
December 31, 2009, under the terms of the operating lease for the facility in
Vernon Hills, Illinois are as follows:





Year ending December 31,
            
            Amount2010
            
            $
            37,266





Rental expense, including allocated
operating costs and taxes, was $123,313 and $125,100 for the years ended
December 31, 2009 and 2008, respectively.





Collaboration, Consulting
and Licensing Agreements


Under the terms of various license and
collaborative research agreements with Albert Einstein College of Medicine
(“AECOM”) the Company is obligated to make semi-annual license maintenance
payments and quarterly funding payments to support Dr. Davies lab at
AECOM.  In addition, the agreements call for royalty and revenue
sharing agreements upon the sale and/or license of products or technology
licensed under the agreements.  In March 2002, September 2002, October
2006, December 2008 and November 2009 the Company renegotiated various terms of
the AECOM agreements.  As part of the December 2008 amendment, AECOM
agreed to defer the 2009 semi-annual maintenance payments until the earlier of
December 31, 2009 or a fund raise at least equal to $3,500,000. In exchange for
this deferral, the Company agreed to prepay the quarterly funding payments that
were due in February 2009, May 2009 and August 2009.  This prepayment
of $112,500 was made in December 2008.  In the November 2009
amendment, AECOM agreed to defer the 2009 semi-annual license maintenance
payments that had previously been deferred until December 31, 2009 and the 2010
semi-annual license maintenance payments until the earlier of December 31, 2010
or a fund raise at least equal to $4,000,000. AECOM also agreed to defer the
quarterly funding payment to support Dr. Davies lab at AECOM that was due in
November 2009 until February 2010.  The Company is currently in
discussions with AECOM on the timing of a payment for AECOM’s percentage of the
$750,000 the Company received from Eli Lilly and Company in December
2009.





Total expense for these outside
research, collaboration and license agreements, included in research and
development expenses, was $500,000 and $500,000 for the years ended December 31,
2009 and 2008, respectively.





The Company has a consulting agreement
with Dr. Peter Davies, its founding scientist, which has been renewed through
November 2011, but in some instances, may be terminated at an earlier date by
the Company and the consultant.  Expense for the consulting agreement,
included in research and development expenses, was $108,000 and $108,000 for the
years ended December 31, 2009 and 2008, respectively.  In December
2008, Dr. Davies agreed to defer a portion of his monthly consulting
fees.  In December 2009, the Company and Dr. Davies agreed to repay
Dr. Davies these deferred consulting fees over twelve months in
2010.





Future minimum payments, as of December
31, 2009, under the above agreements are as follows:





Year ending December
    31,
            
            Collaborations
            
            
            Consulting2010
            
            $
            887,500
            
            
            $
            175,5002011
            
            
            500,000
            
            
            
            99,0002012
            
            
            500,000
            
            
            
            -2013
            
            
            500,000
            
            
            
            -2014
            
            
            500,000
            
            
            
            -Total
            
            $
            2,887,500
            
            
            $
            274,500











The Company is obligated to pay AECOM
$500,000 each year subsequent to 2009 that the Agreements are still in
effect.  In addition, the Company is obligated to pay AECOM a
percentage of all revenues received from selling and/or licensing aspects of the
AD technology licensed from AECOM that exceeds the minimum obligations reflected
in the annual license maintenance payments.  The Company can terminate
the Agreements at any time with sixty days written notice, but would be required
to return all rights granted under the Agreements to AECOM and reimburse AECOM
for any salary obligations undertaken by AECOM for the research projects covered
by the Agreements for up to one year from the termination date.  The
future minimum payments for 2010 include all amounts deferred from 2009 that are
scheduled to be paid in 2010.





Employment
Agreement


The Company’s former President and CEO,
Ellen R. Hoffing, was employed under the terms of a three-year employment
agreement from August 29, 2006 through August 28, 2009.  The
employment agreement required written notice at least 60 days prior to the
expiration date of the agreement in order to prevent an automatic one-year
renewal.  The Company’s Board of Directors provided written notice of
non-renewal to Ms. Hoffing on June 23, 2009.





Contingencies


The Company does not maintain any
product liability insurance for products in development.  The Company
believes that even if product liability insurance were obtained, there is no
assurance that such insurance would be sufficient to cover any
claims.  The Company is unaware of any product liability
claims.





The ability to develop the Company’s
technologies and to commercialize products will depend on avoiding patents of
others.  While the Company is aware of patents issued to competitors,
as of December 31, 2009, the Company was not aware of any claim of patent
infringement against it.





In March 2004, the Company was notified
by email from Innogenetics, a Belgian biopharmaceutical company involved in
specialty diagnostics and therapeutic vaccines, that it believes the CSF
diagnostic test the Company has been developing uses technology that is
encompassed by the claims of its’ U.S. patents.  Innogenetics also
informed the Company that it could be amenable to entering into a licensing
arrangement or other business deal with the Company regarding its
patents.  The Company had discussions with Innogenetics concerning a
potential business relationship, however, until recently, no further discussions
had been held since the second quarter of 2006.





The Company has reviewed these patents
with its patent counsel on several occasions prior to receipt of the email from
Innogenetics and subsequent to receipt of the email.  Based on these
reviews, the Company believes that its CSF diagnostic test does not infringe the
claims of these Innogenetics patents.  If the Company is unable to
reach a mutually agreeable arrangement with Innogenetics, it may be forced to
litigate the issue.  Expenses involved with litigation may be
significant, regardless of the ultimate outcome of any litigation.  An
adverse decision could prevent the Company from possibly marketing a future
diagnostic product and could have a material adverse impact on its
business.  No reserve has been recorded at December 31,
2009.





Note
10 – Notes Payable





On July 10, 2006, the Company entered
into a Note and Warrant Purchase Agreement with private investors pursuant to
which the Company sold to the investors 12% senior unsecured notes due January
10, 2007 in the aggregate principal amount of $500,000 (“Bridge Funding”), and
five year warrants (the “Warrants”) exercisable to purchase an aggregate of
30,750 shares of the Company’s common stock at an exercise price of $.075 per
share.  The Notes, plus accrued interest, were paid in full as of
January 10, 2007.  The Notes were not guaranteed by any third party,
and not secured by the Company, and were senior to all of the Company’s
indebtedness and were non-transferable.





Based on the accounting literature at
the time of the transaction, the Company concluded that no obligation should be
recorded related to the registration rights for the warrants issued and the cost
of the warrants are classified as equity.





The Company allocated the proceeds from
the Bridge Funding of $500,000 between the debt and the warrants based upon the
fair value of the debt and warrants at the transaction date.  The
warrants were valued using the Black-Scholes pricing model.  This
resulted in an increase in additional paid-in capital at the transaction
date





related
to the warrants in the amount of $200,866.  The carrying value of the
debt was reduced by the $200,866 and the discount was amortized over the life of
the loan (6 months).  During 2007 and 2006, $11,159 and $189,707 of
the discount was recognized as interest expense, respectively.





The fair value of the warrants issued
was determined using the Black-Scholes option pricing model based on the
following assumptions: volatility of 75%, expected life of two years, risk free
interest rate of 5.14% and no dividends.





On
December 31, 2008, the Company entered into Convertible Note Purchase Agreements
(the “Purchase Agreement”) with private investors pursuant to which the Company
sold to the investors 12% convertible notes due June 30, 2010 in the aggregate
principal amount of $535,000 (the “Notes”).  $500,000 of the Notes was
closed on in December 2008 and is reflected as Notes Payable as of December 31,
2008.  The remaining $35,000 was closed on in January
2009.  The price at which principal of the Notes will be converted
into shares of Common Stock (the “Note Conversion Price”) shall be equal to the
lesser of (i) the average closing price of the Common Stock on the OTC Bulletin
Board for the 20 trading day period immediately preceding the date of the
Closing, (ii) $1.20 (as adjusted for the Company’s reverse-stock-split in June
2009), or (iii) the per share price (or conversion price) in any subsequent
financing while the debt is outstanding (in each case as such amount is
equitably adjusted to reflect any stock split, reverse stock split or stock
dividend carried out by the Company).  The current conversion price of
$.873 per share was determined by the average closing price of the Company’s
common stock for the twenty trading days immediately preceding December 31,
2008, adjusted for the Company’s reverse-stock-split in June 2009.  At
December 31, 2008, there is no deemed beneficial conversion feature related to
the Convertible Note Payable.  As of December 31, 2009 and 2008, the
carrying cost of these notes approximates fair value.  The Notes are
not secured and are non-transferable.





Pursuant to the Purchase Agreement, the
Company has granted to the investors demand registration rights for the shares
of common stock that would be issued upon conversion of the Note principal and
piggyback registration rights for the shares of common stock that would be
issued upon conversion of the Note interest.





Note
      11 – Authorized Shares





The Company discovered in the first
quarter of 2006 that three prior amendments to its certificate of incorporation
were approved by written consent of the stockholders.  The first
amendment, approved in October 2001 and filed in November 2001, increased the
Company's authorized common stock from 22.4 million shares to 50 million shares,
and the second amendment, approved in June 2003 and filed in September 2003,
increased the authorized common stock to 200 million shares.  The
third amendment to the Company's certificate of incorporation was approved and
filed in October 2003 to change the name of the Company to “Applied
NeuroSolutions, Inc.”  For each of these amendments, the Company filed
an information statement and duly mailed it to stockholders 20 days prior to
effective date of the stockholders' written consents becoming effective, all in
accordance with the Exchange Act and its applicable rules.





In January 2006, in preparation of the
proxy statement for the Company’s annual meeting, the Company discovered that
the certificate of incorporation of its predecessor entity, Ophidian
Pharmaceuticals, Inc., limited stockholders from taking action by written
consent.  That provision is still in effect.  Consequently,
the 2001 and 2003 amendments to the certificate of incorporation, while approved
by the Board of Directors and approved by a majority of the then-outstanding
shares of common stock in the manner described above, were technically not
adopted properly under Delaware law.  Such shares may be deemed issued
in excess of the Company's 22,400,000 authorized and outstanding shares of
common stock.





To remedy this technical error, the
Company corrected its certificate of incorporation by means of a
subsidiary-parent merger approved by the stockholders, with a new “corrected”
certificate of incorporation resulting from such merger.





To assure that this correction would be
made, thereby preserving the status quo for the Company's existing common
stockholders, the Company created a new class of “super voting” Series A
preferred stock, which is permitted by the “blank check” provisions of the
current certificate of incorporation that was approved by the stockholders of
the Company's predecessor at an annual meeting held in 1999.  The
shares of this Series A preferred stock were issued solely to the members of the
Company's Audit Committee, in trust for the benefit of the





Company's
common stockholders.  The members of the Audit Committee agreed to
vote the shares in favor of the curative merger
transaction.  Following the merger transaction and the correction of
the certificate of incorporation to affirm the previous actions of the Company's
stockholders, the Company redeemed and canceled the shares of the Series A
preferred stock at a nominal cost of $250.





The Board of Directors
unanimously approved the Merger Agreement and the approach
outlined above.


The
Company’s annual meeting was held on June 20, 2006 and the parent-subsidiary
merger, as described above, was approved and the Company immediately filed a
certificate of merger to effect the technical correction to its certificate of
incorporation.  The Company’s authorized common stock under Article IV
of the amended and restated certificate of incorporation is now 200 million
shares.





Because the holders of the Series A
preferred stock had informed the Company of their agreement with each other to
vote the Series A preferred shares in favor of the Merger Agreement, the Company
continued to treat the over-issued shares of common stock in the same manner as
the remaining outstanding shares of the Company’s common stock.





In September 2008, the Company’s
shareholders approved an amendment to the Company’s certificate of incorporation
to effect a reverse stock split of the Company’s common stock at any time prior
to June 30, 2009 at a ratio between 1-for-20 and 1-for-30 as determined by the
Company’s Board of Directors and to decrease the Company’s authorized common
stock from 200 million shares to 100 million shares.  In June 2009,
the Company’s Board of Directors authorized and executed a 1-for-30 reverse
stock split.





Note
12 – Quarterly Financial Data (Unaudited)





2009
            
            Fourth
      Quarter
            
            
            Third
      Quarter
            
            
            Second
      Quarter
            
            
            First
      QuarterTotal
      Revenues
            
            $
            926,400
            
            
            $
            208,333
            
            
            $
            208,333
            
            
            $
            208,333Total
      Operating Expenses
            
            
            491,391
            
            
            
            601,853
            
            
            
            773,026
            
            
            
            732,615Net
      Income (Loss)
            
            
            418,960
            
            
            
            (409,428
            )
            
            
            (579,537
            )
            
            
            (537,737
            )Net
      Income (Loss) Per Share
            
            $
            0.10
            
            
            $
            (0.09
            )
            
            $
            (0.13
            )
            
            $
            (0.12
            )2008Total
      Revenues
            
            $
            213,134
            
            
            $
            208,333
            
            
            $
            208,333
            
            
            $
            208,333Total
      Operating Expenses
            
            
            685,235
            
            
            
            794,780
            
            
            
            805,271
            
            
            
            828,254Net
      Income (Loss)
            
            
            (468,792
            )
            
            
            (579,146
            )
            
            
            (585,822
            )
            
            
            (598,608
            )Net
      Income (Loss) Per Share
            
            $
            (0.11
            )
            
            $
            (0.13
            )
            
            $
            (0.13
            )
            
            $
            (0.14
            )








ITEM
9.  CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE.







None.





ITEM
9A. CONTROLS AND PROCEDURES




(a)Disclosure
Controls and Procedures.   Our management, with the
participation of our principal executive officer (chief executive officer) and
principal financial officer (chief financial officer), has conducted an
evaluation of the effectiveness of the design and operation of our disclosure
controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the
Securities Exchange Act of 1934, as amended (the “Exchange Act”), as of the end
of the period covered by this report (the “Evaluation Date”).  Based
on this evaluation, and due to the material weaknesses in our internal control
over financial reporting (as described below in the “Report of Management on Applied
NeuroSolutions, Inc.’s Internal Control over Financial Reporting”), our
chief executive officer and chief financial officer concluded that as of
December 31, 2009, our disclosure controls and procedures were not
effective to ensure that information required to be disclosed by us in reports
that we file or submit under the Exchange Act is recorded, processed, summarized
and reported within the time periods specified in SEC rules and
forms.






(b)Internal
Controls Over Financial
Reporting.      There was no change in our
internal control over financial reporting during our most recently completed
fiscal quarter that has materially affected or is reasonably likely to
materially affect our internal control over financial reporting.  Set
forth below is the “Report of
Management on Applied NeuroSolutions, Inc.’s Internal Control over Financial
Reporting”




Report
of Management on Applied NeuroSolutions, Inc.’s Internal Control Over Financial
Reporting




Our principal executive officer (chief
executive officer) and principal financial officer (chief financial officer), as
members of management of Applied NeuroSolutions, Inc., are responsible for
establishing and maintaining adequate internal control over financial reporting,
as such term is defined in Exchange Act Rules 13a-15(f) or
15d-15(f).  Internal control over financial reporting is a process
designed to provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles.  Internal
control over financial reporting includes those policies and procedures that
(1) pertain to the maintenance of records that, in reasonable detail,
accurately and fairly reflect the transactions and dispositions of our assets;
(2) provide reasonable assurance that transactions are recorded as
necessary to permit preparation of financial statements in accordance with
generally accepted accounting principles, and that our receipts and expenditures
are being made only in accordance with authorizations of our management and
directors; and (3) provide reasonable assurance regarding prevention or
timely detection of unauthorized acquisition, use, or disposition of our assets
that could have a material effect on the financial statements.




Because of its inherent limitations,
our internal controls and procedures may not prevent or detect
misstatements.  A control system, no matter how well conceived and
operated, can provide only reasonable, not absolute, assurance that the
objectives of the control system are met. Because of the inherent limitations in
all control systems, no evaluation of controls can provide absolute assurance
that all control issues and instances of fraud, if any, have been
detected.  Also, projections of any evaluation of effectiveness to
future periods are subject to the risk that controls may become inadequate
because of changes in conditions, or that the degree of compliance with the
policies and procedures may deteriorate.




The following material weaknesses have
been identified by members of our management and reported to the audit
committee:




·
            We
      lack segregation of duties in the period-end financial reporting
      process.  Our Chief Financial Officer (“CFO”) is the only
      employee with any significant knowledge of generally accepted accounting
      principles. The CFO is also the sole employee in charge of the general
      ledger (including the preparation of routine and non-routine journal
      entries and journal entries involving accounting estimates), the
      preparation of accounting reconciliations, the selection of accounting
      principles, and the preparation of interim and annual financial statements
      (including report combinations, consolidation entries and footnote
      disclosures) in accordance with generally accepted accounting
      principles.







·
            We
      use accounting software that has inherent control deficiencies over user
      access and audit trail
capabilities.




As of December 31, 2009, our
management, with the participation of our chief executive officer and chief
financial officer, documented our control environment, however, management did
not assess our internal control over financial reporting based on criteria for
effective internal control over financial reporting as described in “Internal
Control — Integrated Framework” issued by the Committee of Sponsoring
Organizations (“COSO”) of the Treadway Commission.  As a result of the
material weaknesses described above, management has concluded that our internal
controls over financial reporting were not effective as of December 31,
2009.








ITEM
9B. OTHER INFORMATION





None.











PART
III





ITEM
      10.   DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE
      GOVERNANCE





Our executive officers and directors
as of December 31, 2009, and their ages as of February 28, 2010, are as
follows:








Name
            
            Age
            
            PositionCraig
      S. Taylor (5)(7)
            
            46
            
            President,
      Chief Executive Officer, Class II Director and Acting Secretary and Chief
      Financial OfficerEllen
      R. Hoffing (4)
            
            53
            
            Chairman
      of the Board of Directors & Class II DirectorAlan
      L. Heller (1)(2)(6)
            
            56
            
            Class
      III DirectorEdward
      A. Ogunro (2)(3)
            
            57
            
            Class
      I DirectorGary
      C. Parks (1)
            
            59
            
            Class
      III DirectorDavid
      C. Tiemeier (3)
            
            63
            
            Class
      I Director





(1)
            Member
      of the Audit Committee


(2)
            Member
      of the Compensation Committee


(3)
            Member
      of Nominating and Governance
Committee


(4)
            President
      and Chief Executive Officer until September 1,
  2009


(5)
            President,
      Chief Executive Officer and Class II Director as of September 1,
      2009


(6)
            Resigned
      as Class III Director on January 14,
2010


(7)
            Effective
      on March 5, 2010, Mr. Dave Ellison resigned as our Chief Financial Officer
      and Secretary.  Mr. Craig Taylor is our acting Chief Financial
      Officer and Secretary until we hire Mr. Ellison’s
    replacement.





Craig S. Taylor, Ph.D.,
President and CEO and a Class II director, has been President, Chief Executive
Officer and a Director since September 2009 and he has been our acting Chief
Financial Officer and Secretary since March 5, 2009.  Dr. Taylor was
working as a management consultant prior to joining the Company, and had also
worked as a management consultant from 1994 to 1996.  He was
previously the CEO of a small private biotech company from 2007 to
2008.  Prior to his tenure at Adams Street Partners, LLC where he was
Partner, Direct Venture Capital Investments from 2000 to 2006, Dr. Taylor served
as Associate Director of Business Development for G.D. Searle (now part of
Pfizer) from 1996 to 2000.  Prior to joining Searle in a business
capacity, he served as a Senior Research Biochemist, Project Manager at Abbott
Laboratories (NYSE: ABT) in the Diagnostic Division from 1990 to
1993.  Dr. Taylor’s career has blended his scientific and business
experience, building from his formal education, having earned both a Ph.D. at
Georgetown University, School of Medicine and an MBA from the University of
Chicago, Booth School of Business.








Ellen R. Hoffing, a Class II
director, was appointed Chairman of the Board of Directors in December 2007 and
was President and Chief Executive Officer of the Company from August 29, 2006 to
August 31, 2009.  Ms. Hoffing has been a Director since August 29,
2006.  Ms. Hoffing currently serves on the Board of Directors of one other
public company, Perrigo Company.  Since 2005, she had been a
consultant to healthcare focused companies.  In 2005, Ms. Hoffing was Vice
President, Strategic Planning at American Pharmaceutical Partners, a publicly
traded specialty pharmaceutical company focused on injectable oncology,
anti-infective and critical care products.  From 2002 to 2005, Ms. Hoffing
was Vice President, Renal Pharmaceuticals at Baxter Healthcare, a New York Stock
Exchange listed company.  From 2001 to 2002, she was Vice President,
Strategy and Acquisitions, at Merisant (the maker of Equal®) and from 2000 to
2001, Ms. Hoffing was a strategy and management consultant to healthcare focused
companies.  Prior to 2000, Ms. Hoffing took on roles of increasing
responsibility in her 17 years at the Searle division of Monsanto, which
culminated in her position as Vice President, Global Analytics.





Alan L. Heller, a Class III
director until his resignation on January 14, 2010, had been a director since
September 2006.  Since March 2006, Mr. Heller has been an Operating
Partner at a private equity firm, Water Street Healthcare
Partners.  Mr. Heller currently serves on the Board of Directors of
one other public company, Savient Pharmaceuticals, Inc.  From November
2004 to November 2005, Mr. Heller was President and Chief Executive Officer of
American Pharmaceutical Partners, Inc., a company that develops, manufactures
and markets branded and generic injectable pharmaceutical
products.  From January 2004 to November 2004 Mr. Heller served
as an investment advisor on life science transactions to One Equity Partners, a
private equity arm of JP Morgan Chase.  From 2000 to 2004, Mr. Heller
also served as Senior Vice President and President Global Renal operations at
Baxter Healthcare Corporation.  Prior to joining Baxter, Mr. Heller
spent 23 years at G.D. Searle. He served in several senior level positions
including Co-President and Chief Operating Officer, with responsibility for all
commercial operations worldwide, and Executive Vice President and President,
Searle Operations.





Edward A. Ogunro, Ph.D.,, a
Class I director, has been a director since October 2008.  Dr. Ogunro
recently retired from his position as Senior Vice President, R&D and Medical
Affairs and Chief Scientific Officer at Hospira, Inc. where he was part of the
executive management team that transitioned the company from a division of
Abbott Laboratories in April 2004 to a successful stand-alone entity. Dr. Ogunro
joined Abbott Labs as a Research Biochemist in the Diagnostics Division in June
1982 and took on roles of increasing responsibility including Program Director
for AxSym, one of the most successful analyzers in the diagnostic
industry.  In addition, in his 20 plus years at Abbott Labs, Dr. Ogunro
held senior leadership positions including Divisional Vice President,
Immunodiagnostics and Chemistry in the Diagnostics Division and Corporate Vice
President R&D, Medical and Regulatory Affairs in the Hospital Products
Division. Previously, Dr. Ogunro pursued postdoctoral studies and served as an
Assistant Professor at Northwestern University Medical School in
Chicago.





Gary C. Parks, a Class III
director, has been a director since November 2008.  Since 1993 Mr.
Parks has served as the Secretary, Treasurer and Chief Financial Officer of
Immtech Pharmaceuticals, Inc., a company dedicated to the discovery and
development of therapies to treat infectious diseases affecting the global
community. Previously, Mr. Parks held financial operations roles of increasing
responsibility including Vice President, Finance at Smallbone, Inc., from 1989
until 1993, Division Controller with International Paper from 1986 to 1989 and
Vice President of Serck Baker, Inc., a subsidiary of BTR plc, from 1982 to 1989
and board member of Serck Baker de Venezuela.





David C. Tiemeier, Ph.D., a Class I director, has
been a director since October 2007.  He is currently serving as Deputy
Director of UChicagoTech, the University of Chicago’s Office of Technology and
Intellectual Property.  Previously, Dr. Tiemeier pursued postdoctoral
studies in molecular genetics at the National Institutes of Health before
joining the faculty of the University of California, Irvine, Medical
School.  He joined Monsanto Co. (NYSE:MON) as the head of Molecular
Genetics, and continued his career in Monsanto’s pharmaceutical division as
Senior Director of Immunoinflammatory and Infectious Diseases and took on roles
of increasing responsibility including General Manager of the Global New
Business Franchise and Vice President of Global Business Development.  He
subsequently held senior positions in Pharmacia Corporation and Pfizer
Inc.  Following his retirement from Pfizer, Dr. Tiemeier held senior
management positions with NeoPharm, Inc., Immtech Pharmaceuticals, Inc. and
Kalypsys, Inc.





Board
of directors committees and other information





Since April 1999, the Company's
Certificate of Incorporation and Bylaws have provided that the Company's Board
of Directors is divided into three classes with staggered terms of three years
each.  In June 2006,





the
Company's stockholders voted on initial terms for the three classes of directors
as set forth in the Company’s By-laws, because the terms for all classes of
directors had expired.  As a result of the election of directors in
June 2006, the initial term of the directors of the first class (“Class I”)
expired in 2007, the initial term of the directors of the second class (“Class
II”) expired in 2008 and the initial term of the directors of the third class
(“Class III”) expired in 2009.  The Company’s By-laws require that
directors who are appointed to fill vacancies must stand for election at the
next annual meeting of stockholders and thereafter will stand for election with
the other directors in their class.  After the expiration of the
initial term, all of the Company's directors serve three year terms and hold
office until the third annual meeting of stockholders of the Company following
their election to the Board and until their respective successors have been
qualified and elected.  Officers are elected by, and serve at the
discretion of, the Board of Directors.  On April 20, 2007, Michael
Sorell, MD, a Class III director since November 2004, passed
away.    On January 30, 2007, Bruce N. Barron, a Class I
director since 1994, informed the Company that he would not run for re-election
at the Company’s next annual meeting of stockholders, due to an increase in Mr.
Barron’s external business commitments. On December 7, 2007, Mr. Barron
resigned.  On September 16, 2008, at the Company’s annual stockholders
meeting, the Company’s stockholders approved all directors up for election,
which included all Class I directors, all Class II directors and all directors
who had not previously stood for election.  On October 30, 2008, the
Company appointed Edward A. Ogunro, Ph.D. as a Class I director.  On
November 14, 2008, the Company appointed Gary C. Parks as a Class III director,
replacing Robert S. Vaters, a Class III director since October 2005, who
resigned due to an increase in his external business commitments.  On
December 17, 2008, Jay B. Langner, a Class II director since July 2005, resigned
from the board for personal reasons.  On September 1, 2009, the
Company appointed Craig S. Taylor as a Class II director.  On January
14, 2010, Alan L. Heller, a Class III director since September 2006
resigned  due to an increase in his business commitments.





Section
16(a) beneficial reporting compliance





The Company's executive officers,
directors and shareholders beneficially owning more than 10% of the Company's
Common Stock are required under the Exchange Act to file reports of ownership of
Common Stock of the Company with the Securities and Exchange
Commission.  Copies of those reports must also be furnished to the
Company.  The Company believes that during the preceding year all
filing requirements applicable to executive officers, directors and shareholders
beneficially owning more than 10% of the Company's Common Stock have been
complied with, except for (i) Messrs. David C. Tiemeier, Gary C. Parks, Edward
A. Ogunro and Alan L. Heller, each of whom filed a Form 4 on February 27, 2009
for a stock option grant that occurred on February 24, 2009 and (ii) Craig
Taylor who filed a Form 4 on September 4, 2009 for a stock option grant that
occurred on September 1, 2009.





Committees





In December 2008, the Board of
Directors appointed Gary C. Parks (Chairman) and Alan L. Heller to the Audit
Committee.  Mr. Heller resigned from the Board in January 2010 and
David C. Tiemeier has been appointed as Mr. Heller’s replacement on the audit
committee.  The Audit Committee reviews the scope and results of the
Company's financial statements conducted by the Company's independent
auditors.  The Committee also reviews the scope of other services
provided by the Company's independent auditors, proposed changes in the
Company's financial and accounting standards and principles, and the Company's
policies and procedures with respect to its internal accounting, and auditing
and financial controls.  The Committee makes recommendations to the
Board of Directors on the engagement of the independent auditors, as well as
other matters that may come before it or as directed by the Board of
Directors.  Our Board of Directors has determined that Mr. Parks is an
“audit committee financial expert” within the applicable definition of the
Securities and Exchange Commission.  Each of Mr. Parks, Dr. Tiemeier
and Mr. Heller qualify as independent directors under Rule 10A-3 of the
Securities Exchange Act of 1934 and as defined in NASD Marketplace Rule
4200(15).





In November 2008, the Board of
Directors appointed Alan L. Heller (Chairman) and Edward A. Ogunro to the
Compensation Committee.  Mr. Heller resigned from the Board in January
2010 and Gary C. Parks was added to the Compensation Committee with Dr. Ogunro
appointed the Chairman of the Committee.  The Compensation Committee
makes decisions concerning matters of executive compensation; administers the
Company's executive incentive plans; reviews compensation plans, programs and
policies; and monitors the performance and compensation of executive
officers.  The goal of our Board of Directors executive compensation
policy is to ensure that an appropriate relationship exists between executive
compensation and the creation of stockholder value, while at the same time
attracting, motivating and retaining senior management.Each of Dr. Ogunro, Mr.
Parks and Mr.





Heller
qualify as independent directors under Rule 10A-3 of the Securities Exchange Act
of 1934 and as defined in NASD Marketplace Rule 4200(15).





In November 2008, the Board of
Directors appointed David C. Tiemeier (Chairman) and Edward A. Ogunro to the
Nominating and Governance Committee.  In February 2010, Ellen R.
Hoffing replaced Dr. Ogunro on the Committee.  The Nominating and
Governance Committee participates in identifying qualified individuals to become
directors and determining the composition of the Board and its
committees.  In addition, the Committee reviews and recommends to the
Board of Directors proposed changes to the Company’s Certificate of
Incorporation and By-Laws.  In consultation with the Chairman of the
Board, the Chief Executive Officer and the Chairman of the Committee, the
committee periodically reviews, revises, interprets and confirms compliance with
the Company’s corporate governance policies and corporate governance
guidelines.  The committee recommends to the Board of Directors ways
to enhance services to and improve communications and relations with the
Company’s shareholders; and conducts, in consultation with the Chairman of the
Board, the Chief Executive Officer and the Chairman of the Committee, an annual
review of the Corporation’s Code of Ethics and Business Conduct.  Each
of Dr. Tiemeier and Dr. Ogunro qualify as independent directors under Rule 10A-3
of the Securities Exchange Act of 1934 and as defined in NASD Marketplace Rule
4200(15).  Ms. Hoffing does not currently qualify as an independent
director.





Code
of Ethics





Effective June 1, 2005, we adopted a
code of ethics that applies to all of our directors, officers (including our
chief executive officer and chief financial officer, and any person performing
similar functions) and employees.  We have made our Code of Ethics
available by filing it as Exhibit 14 with our 2005 Annual Report on Form
10-KSB.  In January 2009, we updated the code of
ethics.  The updated code of ethics is included as Exhibit 14 with our
2008 Annual Report on Form 10K.








ITEM
      11.
            EXECUTIVE
      COMPENSATION





SUMMARY
COMPENSATION TABLE


The following table sets forth all
compensation awarded to, earned by, or paid for services in all capacities
during 2009 and 2008 by our President and Chief Executive Officer, Chief
Financial Officer, and Chief Scientific Officer.





Name
      and
              Principal
      Position
            Year
            Salary
            Bonus
            Stock
              Awards
            Option
              Awards
            All
      Other
              Compensation
            TotalCraig
      S. Taylor
              President
      & CEO (1)
            2009
              2008
            $ 83,333
              0
            $             0
              0
            $ 0
              0
            $28,819
              0
            $ 0
              0
            $  112,152
              0Ellen
      R. Hoffing
              President
      & CEO (2)
            2009
              2008
            $221,611
              315,000
            $            0
              0
            $65,631
              70,237
            $139,530
              0
            $ 0
              0
            $  426,772
              385,237David
      Ellison
              CFO
      (3)
            2009
              2008
            $196,458
              205,000
            $ 0
              0
            $ 0
              0
            $ 0
              0
            $ 0
              12,000
            $196,458
              217,000John
      F. DeBernardis
              Chief
      Scientific Officer (4)
            2009
              2008
            $177,292
              185,000
            $ 0
              0
            $ 0
              0
            $ 0
              0
            $ 0
              0
            $177,292
              185,000





(1)
            Dr.
      Taylor began employment as President and Chief Executive Officer of the
      Company on September 1, 2009.  On September 1, 2009, The
      Company’s Board of Directors approved a grant of 203,993 stock options to
      Dr. Taylor.  This option grant was not made under the Company’s
      2003 stock option plan.


(2)
            Ms.
      Hoffing was the President and Chief Executive Officer of the Company from
      September 1, 2006 to August 31, 2009.  Her minimum annual base
      salary per her employment agreement was $300,000.  On August 29,
      2006, The Company’s Board of Directors approved a grant of 200,000 stock
      options and a grant of 13,334 shares of restricted common stock to Ms.
      Hoffing.  The option grant was made pursuant to her employment
      agreement and was not made under the Company’s 2003 stock option
      plan.  Ms. Hoffing’s employment agreement called for $100,000
      additional grants of restricted stock on the first and second anniversary
      of her employment.  On October 23, 2007, the Company’s Board of
      Directors granted Ms. Hoffing 17,544 shares of restricted
      stock.  The Company’s Board of Directors did not grant any
      restricted stock to Ms. Hoffing in 2008.  On August 6, 2009, the
      Company’s Board of Directors granted Ms. Hoffing 153,846 shares of
      restricted stock.  In December 2007, Ms. Hoffing was appointed
      as Chairman of the Company’s Board of Directors.  Effective
      December 1, 2007, the Company’s Board of Directors approved an increase in
      Ms. Hoffing’s annual base salary to $315,000.  In February 2008,
      The Company’s Board of Directors approved a $120,000 bonus for 2007 for
      Ms. Hoffing.  The bonus was made pursuant to her employment
      agreement.  In order to conserve cash for 2009 operations, the
      Company’s Board of Directors and Ms. Hoffing agreed to forego any bonus
      for 2008.  In March 2009, Ms. Hoffing participated in the
      Company’s stock option exchange program, exchanging her 200,000 stock
      options for 66,667 new stock options at a lower exercise
      price.  As of August 31, 2009, the date of Ms. Hoffing’s
      termination, all her stock options were vested and 56,329 shares of
      restricted common stock were
vested.


(3)
            Mr.
      Ellison was employed as Chief Financial Officer of the Company pursuant to
      an agreement through October 31, 2007.  Effective November 1,
      2007, Mr. Ellison continued in his current position with the Company as an
      at-will employee with an annual base salary of $205,000.  In
      2008, the Company included $12,000 in Mr. Ellison’s compensation to
      compensate him for unused vacation time that he had been unable to take
      through December 31, 2007.  On March 5, 2010, Mr. Ellison
      resigned as our Chief Financial Officer and
  Secretary.


(3)
            Dr.
      DeBernardis was employed as Chief Scientific Officer of the Company
      pursuant to an agreement through October 31, 2007.  Effective
      November 1, 2007, Dr. DeBernardis continued in his current position with
      the Company as an at-will employee with an annual base salary of $185,000,
      until he was terminated effective December 31,
  2009.














OUTSTANDING
EQUITY AWARDS AT FISCAL YEAR-END – DECEMBER 31, 2009





Option Awards
            
            Stock AwardsName
            
            Number
      of Securities Underlying Unexercised Options (#) Exercisable
            
            
            Number
      of Securities Underlying Unexercised Options (#) Unexercisable
            
            
            Equity
      Incentive Plan Awards: Number of Securities Underlying Unexercised
      Unearned Options (#)
            
            
            Option
      Exercise Price ($)
            
            Option
      Expiration Date
            
            Number
      of Shares or Units of Stock That Have Not Vested (#)
            
            
            Market
      Value of Shares or Units of Stock That Have Not Vested ($)
            
            
            Equity
      Incentive Plan Awards: Number of Unearned Shares, Units or Other
      Rights That Have Not Vested (#)
            
            
            Equity
      Incentive Plan Awards: Market or Payout Value of Unearned Shares,
      Units or Other Rights That Have Not Vested ($)Craig
      S. Taylor(1)
            
            
            -
            
            
            
            203,993
            
            
            
            -
            
            
            $
            0.700
            
            9/1/2019
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            $
            -Ellen
      R. Hoffing
            
            
            66,667
            
            
            
            -
            
            
            
            -
            
            
            $
            1.485
            
            8/29/2016
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            $
            -David
      Ellison
            
            
            769
            
            
            
            -
            
            
            
            -
            
            
            $
            1.485
            
            11/16/2010
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            $
            -1,829
            
            
            
            -
            
            
            
            -
            
            
            $
            1.485
            
            11/1/2011397
            
            
            
            -
            
            
            
            -
            
            
            $
            1.485
            
            6/1/20125,556
            
            
            
            -
            
            
            
            -
            
            
            $
            1.485
            
            9/2/2013John
      F. DeBernardis
            
            
            2,598
            
            
            
            -
            
            
            
            -
            
            
            $
            1.485
            
            11/16/2010
            
            
            -
            
            
            
            -
            
            
            
            -
            
            
            $
            -4,756
            
            
            
            -
            
            
            
            -
            
            
            $
            1.485
            
            11/1/20111,338
            
            
            
            -
            
            
            
            -
            
            
            $
            1.485
            
            6/1/201216,667
            
            
            
            -
            
            
            
            -
            
            
            $
            1.485
            
            9/2/2013





(1)
            Dr.
      Taylor’s unexercised stock options as of December 31, 2009 will become
      exercisable as follows: 67,998 options will become exercisable on
      September 1, 2010, 67,998 options will become exercisable on September 1,
      2011 and 67,997 options will become exercisable on September 1,
      2012.





Employment
agreement





Ellen R. Hoffing, the Company’s former
President and CEO, was employed under the terms of an employment agreement from
August 29, 2006 through August 28, 2009.  Under the terms of her
employment agreement, Ms. Hoffing received a minimum base salary of $300,000 per
year, plus a bonus of up to 40% of Ms. Hoffing’s base salary upon attainment of
performance objectives established by the Company’s Board of Directors and
acceptable to Ms. Hoffing.  On August 29, 2006, The Company’s Board of
Directors approved a grant of 200,000 stock options and a grant of 13,334 shares
of restricted common stock to Ms. Hoffing.  The option grant was made
pursuant to her employment agreement and was not made under the Company’s 2003
stock option plan.  Ms. Hoffing’s employment agreement called for
$100,000 additional grants of restricted stock on the first and second
anniversary of her employment.  On October 23, 2007, the Company’s
Board of Directors granted Ms. Hoffing 17,544 shares of restricted
stock.  The Company’s Board of Directors did not grant any restricted
stock to Ms. Hoffing in 2008.  On August 6, 2009, the Company’s Board
of Directors granted Ms. Hoffing 153,846 shares of restricted
stock.  Effective December 1, 2007, the Company’s Board of Directors
approved an increase in Ms. Hoffing’s annual base salary to
$315,000.  In February 2008, The Company’s Board of Directors approved
a $120,000 bonus for 2007 for Ms. Hoffing.  The bonus was made
pursuant to her employment agreement.  In order to





conserve
cash for 2009 operations, the Company’s Board of Directors and Ms. Hoffing
agreed to forego any bonus for 2008.  In March 2009, Ms. Hoffing
participated in the Company’s stock option exchange program, exchanging her
200,000 stock options for 66,667 new stock options at a lower exercise
price.  As of August 31, 2009, the date of Ms. Hoffing’s termination,
all her stock options were vested and 56,329 shares of restricted common stock
were vested.





Compensation
of directors





Prior to 2008, Directors received
option grants upon becoming directors and received additional option grants from
time to time as compensation for their service as members of the board of
directors.  In March 2008, the Board of Directors approved a
compensation plan for independent Directors effective as of January 1,
2008.  Each independent Director will receive annually a $5,000 cash
retainer (paid quarterly) plus $1,000 for each in-person Board meeting attended,
$500 for each telephonic Board meeting attended and $500 for each committee
meeting attended.  The total annual cash compensation for each
Director cannot exceed $10,000.  In addition, each independent
Director will receive an annual stock option grant as of the first Board meeting
of the year, valued at $5,000, calculated using a Black-Scholes valuation on the
date of the grant.  The stock options will have an exercise price
equal to the closing price of the Company’s common stock on the day prior to the
grant and will vest on the first business day of January in the following
year.  Directors are reimbursed for reasonable out-of-pocket expenses
incurred in the performance of their duties and the attendance of board meetings
and any meeting of stockholders.  Any new independent Director will
receive a pro-rata annual cash retainer and stock option grant.





DIRECTOR COMPENSATION -
2009


Name
            
            Fees
              Earned
      or
              Paid
      in
              Cash ($)
            
            
            Stock
              Awards(3)
              ($)
            
            
            Option
              Awards(3)
              ($)
            
            
            Non-Equity
              Incentive
      Plan
              Compensation
              ($)
            
            
            Change
      in Pension
              Value
      and Non-
              Qualified
      Deferred
              Compensation
              Earnings
            
            
            All
      Other
              Compensation
              ($)
            
            
            Total ($)Alan
      L. Heller(1)
            
            $
            10,000
            
            
            $
            -
            
            
            $
            5,000
            (4)
            
            $
            -
            
            
            $
            -
            
            
            $
            -
            
            
            $
            15,000Ellen
      R. Hoffing(2)
            
            $
            12,000
            
            
            $
            -
            
            
            
            -
            
            
            $
            -
            
            
            $
            -
            
            
            $
            -
            
            
            $
            12,000Edward
      A. Ogunro(1)
            
            $
            10,000
            
            
            $
            -
            
            
            $
            5,000
            (4)
            
            $
            -
            
            
            $
            -
            
            
            $
            -
            
            
            $
            15,000Gary
      C. Parks(1)
            
            $
            10,000
            
            
            $
            -
            
            
            $
            5,000
            (4)
            
            $
            -
            
            
            $
            -
            
            
            $
            -
            
            
            $
            15,000David
      C. Tiemeier(1)
            
            $
            10,000
            
            
            $
            -
            
            
            $
            5,000
            (4)
            
            $
            -
            
            
            $
            -
            
            
            $
            -
            
            
            $
            15,000





(1)           Independent
Director as of December 31, 2009.


(2)
            Not
      an independent Director as of December 31, 2009.  Ms. Hoffing
      was the Company’s President and CEO From August 26, 2006 through August
      31, 2009.  Ms. Hoffing began receiving $3,000 per month for her
      duties as Chairman of the Board beginning September 1,
    2009.


(3)
            The
      Company’s Independent Board of Directors at December 31, 2009, in
      aggregate, have –0- stock awards and 55,783 option awards.  Ms.
      Hoffing has 56,329 stock awards and 66,667 option
  awards.


(4)           Grant
date fair value as of February 24, 2009.





ITEM
12.  SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
AND RELATED STOCKHOLDER MATTERS





The following table sets forth the
beneficial ownership of our securities as of March 5, 2010, by (a) each person
known by the Company to be the beneficial owner of more than 5% of any class of
the Company’s securities, (b) the Company’s directors, (c) the Company’s
executive officers, and (d) all directors and executive officers as a
group.  Except as listed below, the address of all owners listed is
c/o Applied NeuroSolutions, Inc., 50 Lakeview Parkway, Suite 111, Vernon Hills,
Illinois 60061.  As of March 5, 2010, a total of 4,404,375 shares of
the Company’s common stock were outstanding.
















Nature of Beneficial Owner
            
            Amount
      and nature
              of
      beneficial
              ownership
            
            
            Percent
      of
              Class(1)SF
      Capital Partners, Ltd.
              c/o
      Stark Offshore Management LLC
              3600
      South Lake Drive
              St.
      Francis, WI  53235
            
            
            717,163
            (5)
            
            
            15.6
            %Craig
      S. Taylor (2)
            
            
            -
            (6)
            
            
            *Ellen
      R. Hoffing (3)
            
            
            124,663
            (7)
            
            
            2.8
            %Alan
      L. Heller (4)
            
            
            26,072
            (8)
            
            
            *Edward
      A.Ogunro (4)
            
            
            7,334
            (9)
            
            
            *Gary
      C. Parks (4)
            
            
            7,305
            (10)
            
            
            *David
      C. Tiemeier (4)
            
            
            20,572
            (11)
            
            
            *Benjamin
      Family Trusts
            
            
            276,922
            (12)
            
            
            6.2
            %All
      Directors and Officers as a group
              (6
      persons)
            
            
            185,946
            (13)
            
            
            4.1
            %










*
      Indicates ownership of less than
1.0%





(1)
            Based
      on 4,404,375 shares of common stock outstanding as of March 5, 2010, plus
      each person’s warrants or options that are currently exercisable or that
      will become exercisable within 60 days of March 5,
  2010.


(2)
            Director
      and officer.


(3)
            Director
      and former officer.


(4)
            Director.


(5)
            Consists
      of 510,021 of common stock and 207,142 shares of common stock issuable
      upon the exercise of warrants held by SF Capital Partners Ltd. (“SF
      Capital”).  Michael A. Roth and Brian J. Stark (the “Reporting
      Persons”) are the Managing Members of Stark Offshore Management, LLC,
      (“Stark Offshore”) which acts as investment manager and has sole power to
      direct the management of SF Capital.  Through Stark Offshore,
      the Reporting Persons possess voting and dispositive power over the shares
      of common stock held by SF Capital.


(6)
            Dr.
      Taylor received a grant of 203,993 stock options in September
      2009.  None of these options are currently
      vested.  67,998 vest on September 1, 2010; 67,998 vest on
      September 1, 2011 and 67,997 vest on September 1,
  2012.


(7)
            Consists
      of 1,667 shares of common stock, 66,667 shares of common stock issuable
      upon the exercise of currently exercisable stock options and 56,329 shares
      of restricted stock, of which all are vested as of March 5,
      2010


(
      8)
            Consists
      of 5,500 shares of common stock and 20,572 shares of common stock issuable
      upon the exercise of currently exercisable stock
  options.


(9)
            Consists
      of 7,334 shares of common stock issuable upon the exercise of currently
      exercisable stock options.


(10)
            Consists
      of 7,305 shares of common stock issuable upon the exercise of currently
      exercisable stock options.


(11)
            Consists
      of 20,572 shares of common stock issuable upon the exercise of currently
      exercisable stock options.







(12)
            Consists
      of 273,588 shares of common stock held by various family trusts and 3,334
      shares of common stock held by a family member.  The trustee of
      these various family trusts is Wilmington Trust Corporation and Wilmington
      Trust Company, 1100 North Market Street, Wilmington, DE
    19890.


(13)
            Consists
      of 7,167 shares of common stock, 131,001 shares of common stock issuable
      upon the exercise of currently exercisable stock options, and 56,329
      shares of restricted stock, of which all are vested as of March 5,
      2010.





Securities
authorized for issuance under equity compensation plans





In October 2002, the Board of Directors
approved a Stock Option Plan (the “Plan”) under which officers, employees,
directors and consultants may be granted incentive or non-qualified stock option
to acquire common stock.  The incentive stock options granted under
the Plan are intended to meet the requirements of Section 322 of the Internal
Revenue Code of 1986.  The exercise price of each option is no less
than the market price of our stock on the date of the grant, and an option’s
maximum term is ten years.  Options typically vest over one to three
year periods.  The Plan calls for a maximum of 400,000 options to
purchase shares of common stock.  The Plan was approved by
shareholders in 2003.  A registration statement, Form S-8, was filed
in December 2004, registering the stock option plan.





In 2008, independent directors were
granted 16,937 stock options as part of our compensation plan for independent
directors.  In addition, 10,663 stock options expired, unexercised in
April 2008.





In 2009, independent directors were
granted 26,660 stock options as part of our compensation plan for independent
directors.  Our new President and CEO was granted 203,993 stock
options.  This option grant was not made under the Company’s 2003
stock option plan.  In addition, 12,392 stock options expired,
unexercised during 2009.





On March
6, 2009, the Company entered into stock option exchange agreements with five
employees and the Company’s founding scientist.  In return for
exchanging 360,465 previously granted stock options with exercise prices ranging
from $4.50 to $8.55, the Company issued 120,155 new stock options, 1 new option
for every 3 options returned, with an exercise price of $1.485.  This
exercise price represented a 25% premium to the Company’s closing price on the
day prior to the exchange.  The vesting schedules and the expiration
dates of the new options are the same as the vesting schedules and expiration
dates of the returned options.  The stock option exchange was approved
by the Company’s Board of Directors.





Our only equity compensation plan is
the Applied NeuroSolutions, Inc. (formerly Hemoxymed, Inc.) 2003 Stock Option
Plan.





The following table summarizes
outstanding options under our Stock Option Plan as of December 31,
2009.  Options granted in the future under the Plan and outside of the
Plan are within the discretion of our Compensation Committee and therefore
cannot be ascertained at this time.





Plan
      Category
            
            (a)
              
              
              
              Number
      of Securities to
              be
      Issued Upon Exercise
              of
      Outstanding Options
            
            
            (b)
              
              
              
              Weighted-Average
              Exercise
      Price of
              Outstanding
      Options
            
            
            (c)
              Number
      of Securities
              Remaining
      Available for
              Future
      Issuance Under
              Equity
      Compensation
              Plans
      (excluding securities
              Reflected
      in column (a))Equity
      compensation plans
              Approved
      by security holders
            
            
            332,801
            
            
            $
            3.402
            
            
            
            50,192Equity
      compensation plans
              not
      approved by security
              holders
            
            
            292,882
            (1)
            
            $
            2.309
            
            
            
            -Total
            
            
            625,683
            
            
            $
            2.891
            
            
            
            50,192








(1)
Consists of an option exercisable to purchase 203,993 shares of our common stock
that was granted to Craig S. Taylor, our President and Chief Executive Officer
and an option to purchase 133,334 shares of common stock that was granted to
Robert S. Vaters in connection with his appointment as Chairman of our Board of
Directors.  In December 2007, Mr. Vaters stepped down as Chairman,
while continuing as a Director of the Company, and returned to the Company
44,445 unvested options from this grant.  A description of the
material terms of the option granted to Dr. Taylor is set forth in Part III,
Item 11 of this Annual Report.  The option granted to Mr. Vaters is
now exercisable for a ten-year period to purchase 88,889 shares of common stock
at an exercise price of $6.00 per share (which was the reverse-split adjusted
closing price of our common stock on the OTC Bulletin Board on June 23,
2006).





ITEM
      13.   CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND
      DIRECTOR INDEPENDENCE





None.





ITEM
14.                      PRINCIPAL
ACCOUNTING FEES AND SERVICES





The following is a summary of the fees
billed to us by Baker Tilly Virchow Krause, LLP for professional services
rendered for the fiscal years ended December 31, 2009 and 2008:











Fee Category
            
            Fiscal
      2009
              Fees
            
            
            Fiscal
      2008
              FeesAudit
      Fees
            
            $
            81,000
            
            
            $
            82,536Audit
      Related Fees
            
            
            -
            
            
            
            345Tax
      Fees
            
            
            -
            
            
            
            1,385All
      Other Fees
            
            
            -
            
            
            
            -Total
      Fees
            
            $
            81,000
            
            
            $
            84,266





Audit
Fees.  Consists of fees billed for professional services
rendered for the audit of our consolidated financial statements and review of
interim consolidated financial statements included in quarterly reports and
services that are normally provided by Baker Tilly Virchow Krause, LLP in
connection with statutory and regulatory filings or engagements.





Audit Related
Fees.  Consists of fees billed for assurance and related
services that are reasonably related to the performance of the audit or review
of our consolidated financial statements and are not reported under “Audit
Fees”.





Tax Fees.  Consists
of fees billed for professional services for tax compliance, tax advice and tax
planning.





All Other
Fees.  Consists of fees for product and services other than the
services reported above.





Policy
on audit committee pre-approval of audit and permissible non-audit services of
independent auditors





The Audit Committee has adopted a
policy that requires advance approval of all audits, audit-related, tax, and
other services performed by our independent registered public accounting
firm.  The policy provides for pre-approval by the Audit Committee of
specifically defined audit and non-audit services.  Unless the
specific service has been previously pre-approved with respect to that year, the
Audit Committee must approve the permitted service before the independent
registered public accounting firm is engaged to perform it.  The Audit
Committee has delegated to the Chair of the Audit Committee authority to approve
permitted service, provided that the Chair reports any decisions to the Audit
Committee at its next scheduled meeting.  All of the services
performed by our independent registered public accounting firm during 2009 and
2008 were pre-approved by the Audit Committee.














PART
      IV





ITEM
      15.   EXHIBITS, FINANCIAL STATEMENT
    SCHEDULES





(a)
Documents filed as a part of this report.





1.
            List
      of Financial Statements.





The
following consolidated financial statements of Applied NeuroSolutions, Inc. and
Report of Baker Tilly Virchow Krause, LLP, Independent Registered Public
Accounting Firm, are included in this report:


·
            Report
      of Baker Tilly Virchow Krause, LLP, Independent Registered Public
      Accounting Firm.


·
            Consolidated
      Balance Sheets at December 31, 2009 and
2008


·
            Consolidated
      Statements of Operations for the years ended December 31, 2009 and 2008
      and for the period from March 14, 1992 (inception) to December 31,
      2009


·
            Consolidated
      Statements of Stockholders’ Equity/(Deficit) for the years ended December
      31, 2009 and 2008 and for the period from March 14, 1992 (inception) to
      December 31, 2009


·
            Consolidated
      Statements of Cash Flows for the years ended December 31, 2009 and 2008
      and for the period from March 14, 1992 (inception) to December 31,
      2009


·
            Notes
      to Consolidated Financial Statements for the years ended December 31, 2009
      and 2008 and for the period from March 14, 1992 (inception) to December
      31, 2009





2.
            List
      of all Financial Statement
Schedules.





All
schedules are omitted because they are not applicable or the required
information is shown in the financial statements or notes
thereto.





3.
            Exhibits
      required by Item 601 of Regulation S-K. The following exhibits are filed
      as a part of, or incorporated by reference into, this
    Report:





Number
            Description3.1
            Certificate
      of Incorporation, filed as Exhibit C to the Company Proxy Statement on
      Schedule 14A filed on February 23, 1999 (the "Proxy Statement")
      and incorporated herein by reference.3.1.1
            Certificate
      of Amendment of Certificate of Incorporation, filed as Exhibit A to the
      Company's
      Proxy         Statement on
      Schedule 14A, filed on June 29, 1999 and incorporated herein by
      reference.3.1.2
            Certificate
      of Amendment of Certificate of Incorporation, filed as Exhibit 3.1.2 to
      the Company’s Registration Statement on Form SB-2 SEC File Number
      333-84412, filed on March 15, 2002 (the “March 2002 Registration
      Statement”) and incorporated herein by reference.3.1.3
            Amended
      and Restated Certificate of Incorporation filed as Exhibit B to the
      Company’s Proxy Statement on Schedule 14A filed on May 15, 2006 and
      incorporated herein by reference.3.1.4
            Certificate
      of Designation of Series A Preferred Stock, filed as Exhibit 4.1 to the
      Company’s Current Report on Form 8-K, dated April 25, 2006, filed on May
      1, 2006 and incorporated herein by reference.3.1.5
            Certificate
      of Amendment to the Amended and Restated Certificate of Incorporation
      filed as Exhibit 2.1 to the Company’s Current Report on Form 8-K, dated
      June 5, 2009 and incorporated herein by reference.3.2
            Company
      Bylaws, filed as Exhibit D to the February 1999 Proxy Statement and
      incorporated herein by reference.4.1
            Specimen
      Common Stock Certificate, filed as Exhibit 4.1 to Amendment No. 3 to the
      Company's Registration Statement on Form S-1, 1998, Registration Number
      333-33219 (the "1998 Registration Statement") filed on January 27, 1998
      and incorporated herein by reference.4.1.1
            Specimen
      Common Stock Certificate, identifying the Company name change from
      Ophidian Pharmaceuticals, Inc. to Hemoxymed, Inc., filed as Exhibit 4.1.1
      to the March 2002 Registration Statement and incorporated herein by
      reference.4.2
            Specimen
      Warrant Certificate, filed as Exhibit 4.2 to Amendment No. 4 to the 1998
      Registration Statement filed on January 29, 1998 and incorporated herein
      by reference.4.3
            Form
      of Representatives' Warrant Agreement, including Specimen Representatives'
      Warrant filed as Exhibit 4.3 to Amendment No. 4 the 1998 Registration
      Statement filed on January 29, 2004 and incorporated herein by
      reference.4.4
            Form
      of Warrant Agreement filed as Exhibit 4.4 to Amendment No. 4 to the 1998
      Registration Statement filed on January 29, 2004 and incorporated herein
      by reference.4.5
            Specimen
      Unit Certificate filed as Exhibit 4.5 to Amendment No. 5 to the 1998
      Registration Statement filed on February 5, 1998 and incorporated herein
      by reference.4.6
            Hemoxymed,
      Inc. 2003 Stock Option Plan filed as Appendix B to the Company’s
      definitive revised information statement on Schedule 14C filed on August
      29, 2003 and incorporated herein by reference.#4.7
            Form
      of warrant agreement, filed as Exhibit 4.1 to the Company’s quarterly
      report on Form 10-QSB for the quarter ended September 30, 2007, and
      incorporated herein by reference.4.8
            Form
      of convertible note purchase agreement, filed as Exhibit 10.1 to the
      Company’s Current Report on Form 8-K filed on December 31,
      2008.








4.9
            Form
      of convertible promissory note, filed as Exhibit 10.2 to the Company’s
      Current Report on Form 8-K filed on December 31, 2008.10.1
            Agreement
      and Plan of Merger made as of April 16, 2001, by and among the Company,
      Ophidian Holdings, Inc., a wholly owned subsidiary of the Company, and
      Hemoxymed, Inc., filed as Exhibit A to the Company's Information Statement
      on Schedule 14f-1, SEC File No. 005-55419, filed on August 8, 2001 and
      incorporated herein by reference.10.2
            Agreement
      and Plan of Merger made as of September 10, 2002, by and among the
      Company, Molecular Geriatrics Acquisition, Inc., a wholly owned subsidiary
      of the Company, and Molecular Geriatrics Corporation, filed as Exhibit 2.1
      to the Company's Current Report on Form 8-K filed on September 23, 2002
      and incorporated herein by reference.10.3
            License
      and Collaborative Research Agreement, dated October 1, 1992 between
      Molecular Geriatrics Corporation and Albert Einstein College of Medicine,
      including Amendment Agreement dated July 1, 1993 filed as Exhibit 10.3 to
      the Company’s Annual Report on Form 10-KSB for the year ended December 31,
      2002 filed on March 31, 2003 (the “2002 10-KSB”) and incorporated herein
      by reference.10.4
            License
      and Collaborative Research Agreement, dated February 1, 1994 between
      Molecular Geriatrics Corporation and Albert Einstein College of Medicine
      filed as Exhibit 10.4 to the Company’s 2002 10-KSB and incorporated herein
      by reference.10.5
            Amendment
      Agreement, dated March 24, 2002 between Molecular Geriatrics Corporation
      and Albert Einstein College of Medicine filed as Exhibit 10.5 to the
      Company’s 2002 10-KSB and incorporated herein by
  reference.10.6
            Second
      Amendment Agreement, dated September 21, 2002 between Molecular Geriatrics
      Corporation and Albert Einstein College of Medicine filed as Exhibit 10.6
      to the Company’s 2002 10-KSB, and incorporated herein by
      reference.10.7
            Consulting
      Agreements with Dr. Peter Davies, dated October 13, 1992, October 13,
      1992, and January 31, 1994 filed as Exhibit 10.7 to the Company’s 2002
      10-KSB and incorporated herein by reference.10.8
            Lease
      Agreement, dated November 22, 1996, along with First Amendment to Lease,
      dated May 2, 1997, and Lease Extension, dated March 18, 2002 between
      Molecular Geriatrics Corporation and Arthur J. Rogers & Co filed as
      Exhibit 10.10 to the Company’s 2002 10-KSB and incorporated herein by
      reference.10.9
            Form
      of Registration rights Agreement, filed as Exhibit 4.4 to the Company's
      February 2004 8-K and incorporated herein by reference.10.10
            Form
      of Warrant, filed as Exhibit 4.5 to the Company's February 2004 8-K and
      incorporated herein by reference.10.11
            Placement
      Agent Warrant, filed as Exhibit 4.6 to the Company's February 2004 8-K and
      incorporated herein by reference.10.12
            Collaboration
      Agreement, dated November 27, 2006, between Applied NeuroSolutions, Inc.
      and Eli Lilly and Company, filed as Exhibit 10.22 to the Company’s annual
      report on Form 10-KSB for the year ended December 31, 2006 and
      incorporated herein by reference (Portions of this exhibit have been
      omitted pursuant to a request for confidential
  treatment.)10.13
            Agreement
      and Plan of Merger, dated as of April 27, 2006, by and between Applied
      NeuroSolutions, Inc. and APNS Merger Corp., filed as Exhibit 10.1 to the
      Company’s Current Report on Form 8-K, dated April 25, 2006, filed on May
      1, 2006 and incorporated herein by
reference.








10.14
            Letter
      Agreement, dated as of January 25, 2007, between Applied NeuroSolutions,
      Inc. and Bruce N. Barron filed as Exhibit 10.26 to the Company’s annual
      report on Form 10-KSB for the year ended December 31, 2006 and
      incorporated herein by reference.10.15
            Third
      Amendment Agreement, dated October 30, 2006 between Applied
      NeuroSolutions, Inc. and Albert Einstein College of Medicine, filed as
      Exhibit 10.27 to the Company’s annual report on Form 10-KSB for the year
      ended December 31, 2006 and incorporated herein by
    reference.10.16
            Lease
      Extension, dated April 23, 2007, between Applied NeuroSolutions, Inc. and
      Arthur J. Rogers & Co., filed as Exhibit 10.16 to the Company’s annual
      report on Form 10-KSB for the year ended December 31, 2007 and
      incorporated herein by reference.10.17
            Employment
      Agreement, dated as of March 17, 2008 but effective as of August 29, 2006,
      between Applied NeuroSolutions, Inc. and Ellen R. Hoffing, filed as
      Exhibit 10.17 to the Company’s annual report on Form 10-KSB for the year
      ended December 31, 2007 and incorporated herein by reference.
      #10.18
            Form
      of letter agreement between Applied NeuroSolutions, Inc. and certain
      warrant holders filed as Exhibit 10.1 to the Company’s quarterly report on
      Form 10-QSB for the quarter ended June 30, 2007 and incorporated herein by
      reference.10.19
            Purchase
      Agreement, dated September 28, 2007, by and between Applied
      NeuroSolutions, Inc. and SF Capital Partners Ltd., filed as Exhibit 10.1
      to the Company’s quarterly report on Form 10-QSB for the quarter ended
      September 30, 2007, and incorporated herein by
  reference.10.20
            Registration
      Rights Agreement, dated September 28, 2007, by and between Applied
      NeuroSolutions, Inc. and SF Capital Partners Ltd., filed as Exhibit 10.2
      to the Company’s quarterly report on Form 10-QSB for the quarter ended
      September 30, 2007, and incorporated herein by
  reference.10.21
            Convertible
      Note Purchase Agreement, dated as of December 31, 2008, by and between
      Applied NeuroSolutions, Inc. and investors identified therein, filed as
      exhibit 10.1 to the Company’s Current Report on Form 8-K, dated December
      31, 2008, filed on January 7, 2009, and incorporated herein by
      reference.10.22
            Form
      of Convertible Promissory Note, filed as exhibit 10.2 to the Company’s
      Current Report on Form 8-K, dated December 31, 2008, filed on January 7,
      2009, and incorporated herein by reference.10.23
            Consulting
      Agreement, dated as of December 1, 2008, by and between Applied
      NeuroSolutions, Inc. and Dr. Peter Davies, filed as Exhibit 10.23 to the
      Company’s annual report on Form 10-K for the year ended December 31, 2008
      and incorporated herein by reference.10.24
            Fourth
      Amendment Agreement, dated December 1, 2008, between Applied
      NeuroSolutions, Inc. and Albert Einstein College of Medicine, filed as
      Exhibit 10.24 to the Company’s annual report on Form 10-K for the year
      ended December 31, 2008 and incorporated herein by
    reference.10.25
            Fifth
      Amendment Agreement, dated November 1, 2009, between Applied
      NeuroSolutions, Inc. and Albert Einstein College of Medicine.
      *10.26
            First
      Amendment, dated November 25, 2009, between Applied NeuroSolutions, Inc.
      and Eli Lilly and Company * (Portions of this exhibit have been omitted
      pursuant to a request for confidential treatment.)10.27
            Second
      Amendment, dated December 20, 2009, between Applied NeuroSolutions, Inc.
      and Eli Lilly and Company * (Portions of this exhibit have been omitted
      pursuant to a request for confidential treatment.)14
            Code
      of Ethics, amended as of January 1, 2009, filed as Exhibit 14 to the
      Company’s annual report on Form 10-K for the year ended December 31, 2008
      and incorporated herein by reference.16.1
            Letter
      from KPMG to the SEC dated October 25, 2004, filed as Exhibit 16.1 to the
      Company’s Current Report on Form 8-K, dated October 25, 2004, filed on
      October 25, 2004 and incorporated herein by reference.16.2
            Letter
      from KPMG to the SEC dated November 5, 2004, filed as Exhibit 16.2 to
      Amendment No. 1 to the Company’s Current Report on Form 8-K/A, dated
      October 25, 2004, filed on November 5, 2004 and incorporated herein by
      reference.23.1
            Consent
      of Baker Tilly Virchow Krause,
LLP.*








31.1
            Certification
      of Chief Executive Officer/Chief Financial Officer pursuant to Section 302
      of the Sarbanes-Oxley Act of 2002. *32.1
            Certification
      of Chief Executive Officer/Chief Financial Officer pursuant to Section 906
      of the Sarbanes-Oxley Act of 2002.
*








* Exhibit
filed herewith.





#
Management contract or compensatory plan or arrangement.





SIGNATURE
PAGE








In accordance with Section 13 or 15(d)
of the Exchange Act, the registrant has duly caused this report to be signed on
its behalf by the undersigned thereunto duly authorized.








APPLIED
NEUROSOLUTIONS, INC.





Dated:
March 24, 2010


By: /s/ Craig S.
Taylor


Craig
S. Taylor


Acting
Chief Financial Officer


(Principal
Financial


and
Accounting Officer)














In accordance with the Exchange Act,
this report has been signed by the following persons on behalf of the registrant
in the capacities and on the dates indicated.





March 24,
2010                                                                                  By:/s/ Craig S.
Taylor


Craig
S. Taylor


President,
Chief Executive Officer


&
Director & Acting Chief


Financial
Officer


(Principal
Executive Officer and


Principal
Financial and Accounting


Officer)














March 24,
2010                                                                                  By:/s/ Ellen R.
Hoffing


Ellen
R. Hoffing


Chairman
of the Board of Directors








March 24,
2010                                                                                  By:/s/ Edward A.
Ogunro


Edward
A. Ogunro


Director








March 24,
2010                                                                                  By:
/s/ Gary C.
Parks


Gary
C. Parks


Director





March 24,
2010                                                                                  By:
/s/ David C.
Tiemeier


David
C. Tiemeier


Director