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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
 Washington, D.C. 20549
 FORM 10-Q
 (Mark One)
 þ
    
    QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 For the quarterly period ended March 31, 2011
 OR
 o
    
    TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 For the transition period from  to
 Commission file number: 000-50549
 GTx, Inc.
  Delaware(State or other jurisdiction of 
incorporation or organization)
    
    62-1715807
(I.R.S. Employer Identification No.)175 Toyota Plaza7th FloorMemphis, Tennessee
(Address of principal executive offices)
    
    38103
(Zip Code)
 (901) 523-9700
 
 þ o
 o o
  Large accelerated filer o
    
    Accelerated filer þ
    
    Non-accelerated filer o
    
    Smaller reporting company o(Do not check if a smaller reporting company)
 o þ




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##### 



GTx, INC.
FORM 10-Q FOR THE QUARTER ENDED MARCH 31, 2011
INDEX
 PAGEPART I  FINANCIAL INFORMATIONItem 1. Financial Statements (unaudited)Condensed Balance Sheets as of March 31, 2011 and December 31, 2010
    
    
    3Condensed Statements of Operations for the Three Months Ended March 31, 2011 and 2010
    
    
    4Condensed Statements of Cash Flows for the Three Months Ended March 31, 2011 and 2010
    
    
    5Notes to Condensed Financial Statements
    
    
    6Item 2. Managements Discussion and Analysis of Financial Condition and Results of
Operations
    
    
    12Item 3. Quantitative and Qualitative Disclosures About Market Risk
    
    
    20Item 4. Controls and Procedures
    
    
    20PART II  OTHER INFORMATIONItem 1A. Risk Factors
    
    
    21Item 5. Other Information
    
    
    36Item 6. Exhibits
    
    
    36Exhibit 10.29Exhibit 10.50Exhibit 10.58Exhibit 31.1Exhibit 31.2Exhibit 32.1Exhibit 32.2
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##### Table of Contents



PART I: FINANCIAL INFORMATION
 
 ITEM 1.
    
    FINANCIAL STATEMENTS
 GTx, Inc.
 
 CONDENSED BALANCE SHEETS
 (in thousands, except share data)
 March 31,
    
    
    December 31,2011
    
    
    2010(unaudited)ASSETSCurrent assets:Cash and cash equivalents
    
    $
    42,790
    
    
    $
    58,181Short-term investments
    
    
    6,575
    
    
    
    450Accounts receivable, net
    
    
    680
    
    
    
    683Inventory
    
    
    164
    
    
    
    171Prepaid expenses and other current assets
    
    
    1,666
    
    
    
    875Total current assets
    
    
    51,875
    
    
    
    60,360Property and equipment, net
    
    
    1,764
    
    
    
    2,040Intangible and other assets, net
    
    
    223
    
    
    
    1,850Total assets
    
    $
    53,862
    
    
    $
    64,250LIABILITIES AND STOCKHOLDERS EQUITYCurrent liabilities:Accounts payable
    
    $
    658
    
    
    $
    848Accrued expenses and other current liabilities
    
    
    2,576
    
    
    
    3,112Deferred revenue  current portion
    
    
    
    
    
    
    1,345Total current liabilities
    
    
    3,234
    
    
    
    5,305Deferred revenue, less current portion
    
    
    
    
    
    
    6,721Other long-term liabilities
    
    
    246
    
    
    
    497Commitments and contingenciesStockholders equity:Common stock, $0.001 par value: 60,000,000
shares authorized; 51,719,187 shares issued
and outstanding at March 31, 2011 and
December 31, 2010
    
    
    52
    
    
    
    52Additional paid-in capital
    
    
    405,805
    
    
    
    404,555Accumulated deficit
    
    
    (355,475
    )
    
    
    (352,880
    )Total stockholders equity
    
    
    50,382
    
    
    
    51,727Total liabilities and stockholders equity
    
    $
    53,862
    
    
    $
    64,250
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GTx, Inc.
 
 CONDENSED STATEMENTS OF OPERATIONS
 (in thousands, except share and per share data)
 (unaudited)
 Three Months EndedMarch 31,2011
    
    
    2010Revenues:Product sales, net
    
    $
    1,229
    
    
    $
    799Collaboration revenue
    
    
    8,066
    
    
    
    55,778Total revenues
    
    
    9,295
    
    
    
    56,577Costs and expenses:Cost of product sales
    
    
    205
    
    
    
    151Research and development expenses
    
    
    7,303
    
    
    
    7,650General and administrative expenses
    
    
    4,684
    
    
    
    4,509Total costs and expenses
    
    
    12,192
    
    
    
    12,310(Loss) income from operations
    
    
    (2,897
    )
    
    
    44,267Other income, net
    
    
    302
    
    
    
    72Net (loss) income
    
    $
    (2,595
    )
    
    $
    44,339Net (loss) income per share:Basic and diluted
    
    $
    (0.05
    )
    
    $
    1.22Weighted average shares used in computing
net (loss) income per share:Basic and diluted
    
    
    51,719,187
    
    
    
    36,420,901
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GTx, Inc.
 
 CONDENSED STATEMENTS OF CASH FLOWS
 (in thousands)
 (unaudited)
 Three Months EndedMarch 31,2011
    
    
    2010Cash flows from operating activities:Net (loss) income
    
    $
    (2,595
    )
    
    $
    44,339Adjustments to reconcile net (loss) income to net cash used in
operating activities:Depreciation and amortization
    
    
    318
    
    
    
    438Share-based compensation
    
    
    1,199
    
    
    
    1,664Directors deferred compensation
    
    
    51
    
    
    
    50Deferred revenue amortization
    
    
    (8,066
    )
    
    
    (50,778
    )Impairment of intangible asset
    
    
    1,598
    
    
    
    Foreign currency transaction (gain) loss
    
    
    
    
    
    
    (61
    )Changes in assets and liabilities:Accounts receivable, net
    
    
    3
    
    
    
    (113
    )Inventory
    
    
    7
    
    
    
    50Prepaid expenses and other current assets
    
    
    (788
    )
    
    
    (5,790
    )Accounts payable
    
    
    (190
    )
    
    
    (442
    )Accrued expenses and other long term liabilities
    
    
    (766
    )
    
    
    398Net cash used in operating activities
    
    
    (9,229
    )
    
    
    (10,245
    )Cash flows from investing activities:Purchase of property and equipment
    
    
    (16
    )
    
    
    (83
    )Purchase of short-term investments, held to maturity
    
    
    (6,125
    )
    
    
    (3,959
    )Proceeds from maturities of short-term investments, held to maturity
    
    
    
    
    
    
    3,675Net cash used in investing activities
    
    
    (6,141
    )
    
    
    (367
    )Cash flows from financing activities:Payments on capital lease and financed equipment obligations
    
    
    (21
    )
    
    
    (26
    )Net cash used in financing activities
    
    
    (21
    )
    
    
    (26
    )Net decrease in cash and cash equivalents
    
    
    (15,391
    )
    
    
    (10,638
    )Cash and cash equivalents, beginning of period
    
    
    58,181
    
    
    
    40,219Cash and cash equivalents, end of period
    
    $
    42,790
    
    
    $
    29,581
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GTx, Inc.
 
 NOTES TO THE CONDENSED FINANCIAL STATEMENTS
 (in thousands, except share and per share data)  (unaudited)
 1. Business and Basis of Presentation
 Business
  TM TM
  ®
 Basis of Presentation
  Use of Estimates
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GTx, Inc.
NOTES TO THE CONDENSED FINANCIAL STATEMENTS
(in thousands, except share and per share data)
(unaudited)
 Revenue Recognition
 ®
 Collaboration and License Agreements
 Research and Development Expenses
  Cash, Cash Equivalents and Short-term Investments
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GTx, Inc.
NOTES TO THE CONDENSED FINANCIAL STATEMENTS
(in thousands, except share and per share data)
(unaudited)
 Impairment of Long-Lived Assets
    Income Taxes
  Other Income, net
  Subsequent Events
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GTx, Inc.
NOTES TO THE CONDENSED FINANCIAL STATEMENTS
(in thousands, except share and per share data)
(unaudited)
 2. Share-Based Compensation
   Three Months EndedMarch 31,2011
    
    
    2010Research and development expenses
    
    $
    509
    
    
    $
    846General and administrative expenses
    
    
    741
    
    
    
    868Total share-based compensation
    
    $
    1,250
    
    
    $
    1,714
    Three Months EndedMarch 31,2011
    
    
    2010Expected price volatility
    
    
    65.0
    %
    
    
    64.6
    %Risk-free interest rate
    
    
    2.5
    %
    
    
    3.4
    %Weighted average expected life in years
    
    6.5 years
    
    
    6.5 years
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GTx, Inc.
NOTES TO THE CONDENSED FINANCIAL STATEMENTS
(in thousands, except share and per share data)
(unaudited)
  Weighted AverageNumber of
    
    
    Exercise PriceShares
    
    
    Per ShareOptions outstanding at December 31, 2010
    
    
    4,430,495
    
    
    $
    10.91Options granted
    
    
    1,309,500
    
    
    
    2.65Options forfeited or expired
    
    
    (20,965
    )
    
    
    10.82Options outstanding at March 31, 2011
    
    
    5,719,030
    
    
    
    9.02
 3. Basic and Diluted Net Income (Loss) Per Share
  4. Collaboration and License Agreements
 University of Tennessee Research Foundation License Agreements
   Ipsen Collaboration and License Agreement
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GTx, Inc.
NOTES TO THE CONDENSED FINANCIAL STATEMENTS
(in thousands, except share and per share data)
(unaudited)
   Merck & Co., Inc. Collaboration and License Agreement
 TM
    11




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ITEM 2.
    
    MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
  Forward-Looking Information
  
    
    the anticipated progress of our research, development and clinical programs,
including whether any future clinical trials we conduct will achieve similar results to
clinical trials that we have successfully concluded;
 
    
    the timing, scope and anticipated initiation and completion of any future
clinical trials that we may conduct;
 
    
    the timing of regulatory submissions and the timing, scope and anticipated
outcome of related regulatory actions;
 
    
    our ability to establish and maintain potential new collaborative arrangements for the
development and commercialization of our product candidates;
 
    
    ability to obtain and maintain regulatory approvals of our product candidates and any
related restrictions, limitations, and/or warnings in the label of an approved product
candidate;
 
    
    our ability to market, commercialize and achieve market acceptance for our product
candidates or products that we may develop;
 
    
    our ability to generate additional product candidates for clinical testing;
 
    
    our ability to protect our intellectual property and operate our business without
infringing upon the intellectual property rights of others; and
 
    
    our estimates regarding the sufficiency of our cash resources, expenses, capital
requirements and needs for additional financing, and our ability to obtain additional
financing.
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Overview
 Business Overview
  Business Highlights
 TM TM
 TM TM TM TM ® TM
  ®
  13




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Financial Highlights
 ®
 ® ® TM TM TM
 Research and Development
   
    
    the continued clinical development of Ostarine;
    
    the continued clinical development of CapesarisTM; and
    
    the continued preclinical development of other potential product candidates.
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Product Candidates
  ClinicalProduct Candidate/
    
    
    
    DevelopmentProposed Indication
    
    Program
    
    Phase
    
    StatusOstarineTMPrevention and
treatment of muscle
wasting in patients
with non-small cell
lung cancer
    
    SARM
    
    Phase III
    
    Plan to initiate two
pivotal Phase III
clinical trials in the
third quarter of 2011 for
the prevention and
treatment of muscle
wasting in patients with
non-small cell lung
cancer.CapesarisTMFirst line treatment
of advanced prostate
cancer
    
    Selective ER
alpha agonist
    
    Phase IIb
    
    Plan to initiate a Phase
IIb clinical trial in the
second quarter of 2011
for first line treatment
in men with advanced
prostate cancer.
 Sales and Marketing
 ®
 General and Administrative Expenses
 ®
 Critical Accounting Policies and Significant Judgments and Estimates
    15




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Revenue Recognition
 ®
   ® ® ®
 Research and Development Expenses
   16




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Share-Based Compensation
    Results of Operations
 Three Months Ended March 31, 2011 and 2010
 Revenues. ® ® ® ®
  17




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Research and Development Expenses.
 Product Candidate/
    
    
    
    Three Months Ended
    
    
    Increase/Proposed Indication
    
    Program
    
    March 31,
    
    
    Decrease2011
    
    
    2010(in thousands)OstarineTMPrevention and treatment of muscle wasting in
patients
    
    SARM
    
    $
    1,016
    
    
    $
    960
    
    
    $
    56with non-small cell lung cancerCapesarisTMFirst line treatment of advanced prostate cancer
    
    Selective ER alpha agonist
    
    
    2,314
    
    
    
    1,619
    
    
    
    695Other research and development
    
    
    
    
    3,973
    
    
    
    5,071
    
    
    
    (1,098
    )Total research and
development expenses
    
    
    
    $
    7,303
    
    
    $
    7,650
    
    
    $
    (347
    )
 General and Administrative Expenses . ®
 Liquidity and Capital Resources
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® ® TM TM TM
  
    
    the scope, rate of progress and cost of our clinical trials and other research and development activities,
including our currently-planned clinical trials of OstarineTM and CapesarisTM;
    
    the terms and timing of any potential future collaborative, licensing and other arrangements that we may
establish;
    
    future clinical trial results;
    
    the cost and timing of regulatory filings and/or approvals to commercialize our product candidates and any
related restrictions, limitations, and/or warnings in the label of an approved product candidate;
    
    the amount and timing of any licensing fees, milestone payments and royalty payments from potential future
collaborators, if any;
    
    the cost and timing of establishing medical education, sales, marketing and distribution capabilities;
    
    the cost of establishing clinical and commercial supplies of our product candidates and any products that
we and/or any potential future collaborators may develop;
    
    the effect of competing technological and market developments;
    
    the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property
rights, and the cost of defending any other litigation claims; and
    
    the extent to which we acquire or invest in businesses, products and technologies, although we currently
have no commitments or agreements relating to any of these types of transactions.
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® TM TM
 
 ITEM 3.
    
    QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
  
 ITEM 4.
    
    CONTROLS AND PROCEDURES
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PART II: OTHER INFORMATION
 
 ITEM 1A.
    
    RISK FACTORS
   Risks Related to Our Financial Condition and Need for Additional Financing
 We have incurred losses since inception, and we anticipate that we will incur continued losses
for the foreseeable future.*
  TM
  21




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® ® ®
 We will need to raise substantial additional funding and may be unable to raise capital when
needed, which would force us to further delay, reduce or eliminate our product development programs
or commercialization efforts.*
  
    
    fund our operations and conduct clinical trials;
    
    continue our research and development; and
    
    commercialize our product candidates, if any such product candidates
receive regulatory approval for commercial sale.
 ® ® TM TM TM
 
    
    the scope, rate of progress and cost of our clinical trials and other research and development
activities, including our currently-planned clinical trials of OstarineTM and CapesarisTM;
    
    the terms and timing of any potential future collaborative, licensing and other arrangements that we may
establish;
    
    future clinical trial results;
    
    the cost and timing of regulatory filings and/or approvals to commercialize our product candidates and
any related restrictions, limitations, and/or warnings in the label of an approved product candidate;
    
    the amount and timing of any licensing fees, milestone payments and royalty payments from potential
future collaborators, if any;
    
    the cost and timing of establishing medical education, sales, marketing and distribution capabilities;
    
    the cost of establishing clinical and commercial supplies of our product candidates and any products
that we and/or any potential future collaborators may develop;
    
    the effect of competing technological and market developments;
    
    the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual
property rights, and the cost of defending any other litigation claims; and
    
    the extent to which we acquire or invest in businesses, products and technologies, although we currently
have no commitments or agreements relating to any of these types of transactions.
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®
 TM TM
 Risks Related to Development of Product Candidates
 We and any potential future collaborators will not be able to commercialize our product
candidates if our preclinical studies do not produce successful results or if our clinical trials
do not adequately demonstrate safety and efficacy in humans.*
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
    
    regulators or institutional review boards may not authorize us or any potential future
collaborators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
    
    preclinical or clinical trials may produce negative or inconclusive results, which may require us
or any potential future collaborators to conduct additional preclinical or clinical testing or to abandon
projects that we expect to be promising;
    
    even if preclinical or clinical trial results are positive, the FDA or foreign regulatory
authorities could nonetheless require us to conduct unanticipated additional clinical trials;
    
    registration or enrollment in clinical trials may be slower than we currently anticipate,
resulting in significant delays or study termination;
    
    we or any potential future collaborators may suspend or terminate clinical trials if the
participating patients are being exposed to unacceptable health risks;
    
    regulators or institutional review boards may suspend or terminate clinical research for various
reasons, including noncompliance with regulatory requirements; and
    
    our product candidates may not have the desired effects or may include undesirable side effects.
  If we or any potential future collaborators observe serious or other adverse events during the
time our product candidates are in development or after our products are approved and on the
market, we or any potential future collaborators may be required to perform lengthy additional
clinical trials, may be denied regulatory approval of such products, may be forced to change the
labeling of such products or may be required to withdraw any such products from the market, any of
which would hinder or preclude our ability to generate revenues.*
 TM TM
   
    
    we or any potential future collaborators may be required to conduct
additional preclinical or clinical trials, make changes in the labeling of any such
approved products, reformulate any such products, or implement changes to or obtain
new approvals of our contractors manufacturing facilities;
    
    regulatory authorities may be unwilling to approve our product candidates or
may withdraw approval of our products;
    
    we may experience a significant drop in the sales of the affected products;
    
    our reputation in the marketplace may suffer; and
    
    we may become the target of lawsuits, including class action suits.
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Risks Related to Our Dependence on Third Parties
 If we do not establish collaborations for our product candidates or otherwise raise
substantial additional capital, we will likely need to alter our development and any
commercialization plans.*
 TM
 Any collaborative arrangements that we establish in the future may not be successful or we may
otherwise not realize the anticipated benefits from these collaborations. In addition, any future
collaboration arrangements may place the development and commercialization of our product
candidates outside our control, may require us to relinquish important rights or may otherwise be
on terms unfavorable to us.*
   
    
    we may not be able to control the amount and timing of resources that our potential
future collaborators may devote to our product candidates;
 
    
    potential future collaborations may experience financial difficulties or changes in
business focus;
 
    
    we may be required to relinquish important rights such as marketing and distribution
rights;
 
    
    should a collaborator fail to develop or commercialize one of our compounds or
product candidates, we may not receive any future milestone payments and will not
receive any royalties for the compound or product candidate;
 
    
    business combinations or significant changes in a collaborators business strategy
may also adversely affect a collaborators willingness or ability to complete its
obligations under any arrangement;
 
    
    under certain circumstances, a collaborator could move forward with a competing
product candidate developed either independently or in collaboration with others,
including our competitors; and
 
    
    collaborative arrangements are often terminated or allowed to expire, which could
delay the development and may increase the cost of developing our product candidates.
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If third parties do not manufacture our product candidates in sufficient quantities, in the
required timeframe, and at an acceptable cost, clinical development and commercialization of our
product candidates would be delayed.*
  ®
 TM TM
 Use of third-party manufacturers may increase the risk that we will not have adequate supplies
of our product candidates.*
  
    
    reliance on the third party for regulatory compliance and quality assurance;
    
    the possible breach of the manufacturing agreement by the third party because of factors
beyond our control;
    
    the possible termination or non-renewal of the agreement by the third party, based on its
own business priorities, at a time that is costly or inconvenient for us;
    
    drug product supplies not meeting the requisite requirements for clinical trial use; and
    
    the possible exercise by Orion of its right to terminate its obligation to supply us with
toremifene 60 mg tablets, which it may do at its election at any time.
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If third parties on whom we rely do not perform as contractually required or expected, we may
not be able to obtain regulatory approval for or successfully commercialize our product candidates.
  Risks Related to Our Intellectual Property
 If we lose our license from the University of Tennessee Research Foundation, or UTRF, we may
be unable to continue a substantial part of our business.*
 TM
 If some or all of our, or our licensors, patents expire or are invalidated or are found to be
unenforceable, or if some or all of our patent applications do not result in issued patents or
result in patents with narrow, overbroad, or unenforceable claims, or claims that are not supported
in regard to written description or enablement by the specification, or if we are prevented from
asserting that the claims of an issued patent cover a product of a third party, we may be subject
to competition from third parties with products in the same class of products as our product
candidates or products with the same active pharmaceutical ingredients as our product candidates.*
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If we infringe intellectual property rights of third parties, it may increase our costs or
prevent us from being able to commercialize our product candidates.
   
    
    be prohibited from
selling or licensing any
product that we and/or any
potential future
collaborators may develop
unless the patent holder
licenses the patent to us,
which the patent holder is
not required to do;
    
    be required to pay
substantial royalties or
other amounts, or grant a
cross license to our
patents to another patent
holder; or
    
    be required to redesign the
formulation of a product
candidate so that it does
not infringe, which may not
be possible or could
require substantial funds
and time.
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Risks Related to Regulatory Approval of Our Product Candidates
 If we or any potential future collaborators are not able to obtain required regulatory
approvals, we or such collaborators will not be able to commercialize our product candidates, and
our ability to generate revenue will be materially impaired.*
       29




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Risks Related to Commercialization
 The commercial success of any products that we and/or any potential future collaborators may
develop will depend upon the market and the degree of market acceptance among physicians, patients,
health care payors and the medical community.*
  
    
    efficacy and safety results in clinical trials;
    
    the prevalence and severity of any side effects;
    
    potential advantages over alternative treatments;
    
    whether the products we commercialize remain a preferred course of treatment;
    
    the ability to offer our product candidates for sale at competitive prices;
    
    relative convenience and ease of administration;
    
    the strength of marketing and distribution support; and
    
    sufficient third-party coverage or reimbursement.
 Our only marketed product generating revenue is FARESTON ® , which is subject to a
number of risks. These risks may cause sales of FARESTON ® to decline.*
 ® ® ® ® ® ® ®
 
    
    the loss of one or more of our three largest wholesale drug distributors, which together accounted for
approximately 94% of our product sales of FARESTON® for the three months ended March 31, 2011;
    
    any further restrictions, limitations, and/or warnings added to the FARESTON® label;
    
    the continued success of competing products, including aromatase inhibitors;
    
    the loss of coverage or reimbursement for FARESTON® from Medicare and Medicaid, private
health insurers or other third-party payors;
    
    exposure to product liability claims related to the commercial sale of FARESTON®, which may
exceed our product liability insurance;
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
    
    the failure of Orion to maintain regulatory filings or comply with applicable FDA requirements with
respect to FARESTON®;
    
    the introduction of generic toremifene products that compete with FARESTON® for the treatment
of breast cancer;
    
    the loss of Orion, upon which we rely as a single source, as our supplier of FARESTON®; and
    
    the loss of the availability of our website to market FARESTON®, which is an important source
of advertising.
 If we are unable to expand our sales and marketing capabilities or establish and maintain
agreements with third parties to market and sell our product candidates, we may be unable to
generate product revenue from such candidates.
  If we and/or any potential future collaborators are unable to obtain reimbursement or
experience a reduction in reimbursement from third-party payors for products we sell, our revenues
and prospects for profitability will suffer.*
 ®
  ® ®
 ®
  31




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Health care reform measures could hinder or prevent our product candidates commercial
success.
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##### Table of Contents



If product liability lawsuits are brought against us, we may incur substantial liabilities and
may be required to limit commercialization of any products that we may develop.
 ®
 
    
    decreased demand for any product candidates or products;
    
    injury to our reputation;
    
    withdrawal of clinical trial participants;
    
    costs to defend the related litigation;
    
    substantial monetary awards to trial participants or patients;
    
    loss of revenue; and
    
    the inability to commercialize any products for which we obtain
or hold marketing approvals.
  If our competitors are better able to develop and market products than any products that we
and/or any potential future collaborators may develop, our commercial opportunity will be reduced
or eliminated.*
    TM TM ® ® ® ® ® ®
   33




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Risks Related to Employees and Growth
 If we fail to attract and keep senior management and key scientific personnel, we may be
unable to successfully develop or commercialize our product candidates.
   We will need to hire additional employees in order to commercialize our product candidates in
the future. Any inability to manage future growth could harm our ability to commercialize our
product candidates, increase our costs and adversely impact our ability to compete effectively.
    Risks Related to our Common Stock
 Market volatility may cause our stock price and the value of your investment to decline.*
  
    
    delays in the initiation or completion of our currently-planned clinical trials of Ostarine and
CapesarisTM, or adverse results in any of our initiated clinical trials;
    
    our ability to enter into new collaborative arrangements with respect to our product candidates;
    
    the terms and timing of any future collaborative, licensing or other arrangements that we may establish;
    
    our ability to raise additional capital to carry through with our clinical development plans and current and
future operations and the terms of any related financing arrangements;
    
    the timing of achievement of, or failure to achieve, our and any potential future collaborators clinical,
regulatory and other milestones, such as the commencement of clinical development, the completion of a clinical trial or
the receipt of regulatory approval;
    
    announcement of FDA approval or non-approval of our product candidates, or delays in or adverse events during the
FDA review process;
    
    actions taken by regulatory agencies with respect to our product candidates or products, our clinical trials or
our sales and marketing activities, including regulatory actions requiring or leading to restrictions, limitations and/or
warnings in the label of an approved product candidate;
    
    changes to the label for FARESTON® that further restrict how we market and sell FARESTON®;
  34




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
    
    the commercial success of any product approved by the FDA or its foreign counterparts;
    
    introductions or announcements of technological innovations or new products by us, our potential future
collaborators, or our competitors, and the timing of these introductions or announcements;
    
    market conditions for equity investments in general, or the biotechnology or pharmaceutical industries in
particular;
    
    regulatory developments in the United States and foreign countries;
    
    changes in the structure or reimbursement policies of health care payment systems;
    
    any intellectual property infringement lawsuit involving us;
    
    actual or anticipated fluctuations in our results of operations;
    
    changes in financial estimates or recommendations by securities analysts;
    
    sales of large blocks of our common stock;
    
    sales of our common stock by our executive officers, directors and significant stockholders;
    
    changes in accounting principles; and
    
    the loss of any of our key scientific or management personnel.
   Our executive officers, directors and largest stockholders have the ability to control all
matters submitted to stockholders for approval.*
  Anti-takeover provisions in our charter documents and under Delaware law could make an
acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent
attempts by our stockholders to replace or remove our current management.
  
    
    a classified Board of Directors;
    
    a prohibition on actions by our stockholders by written consent;
    
    the ability of our Board of Directors to issue preferred stock
without stockholder approval, which could be used to institute a poison
pill that would work to dilute the stock ownership of a potential hostile
acquirer, effectively preventing acquisitions that have not been approved
by our Board of Directors; and
    
    limitations on the removal of directors.
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If there are substantial sales of our common stock, the market price of our common stock could
drop substantially, even if our business is doing well.*
   
 ITEM 5.
    
    OTHER INFORMATION
  
 ITEM 6.
    
    EXHIBITS
   36




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SIGNATURES
  GTx, Inc.Date: May 9, 2011
    By:
    /s/ Mitchell S. SteinerMitchell S. Steiner, Chief Executive Officerand Vice-Chairman of the Board of DirectorsDate:  May 9, 2011
    By:
    /s/ Mark E. MostellerMark E. Mosteller, Vice Presidentand Chief Financial Officer  37




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EXHIBIT INDEX
 Number
    
    Description3.1
    
    
    Restated Certificate of Incorporation of GTx, Inc.(1)3.2
    
    
    Certificate of Amendment of Restated Certificate of Incorporation of GTx, Inc.(2)3.3
    
    
    Amended and Restated Bylaws of GTx, Inc.(3)4.1
    
    
    Reference is made to Exhibits 3.1, 3.2 and 3.34.2
    
    
    Specimen of Common Stock Certificate(4)4.3
    
    
    Amended and Restated Registration Rights Agreement between Registrant and Oracle
Partners, L.P. dated August 7, 2003(4)4.4
    
    
    Amended and Restated Registration Rights Agreement between Registrant and J. R. Hyde,
III dated August 7, 2003(4)4.5
    
    
    Consent, Waiver and Amendment between the Registrant and Oracle Partners, L.P., Oracle
Investment Management, Inc. and Oracle Institutional Partners, L.P. dated November 29,
2007(5)4.6
    
    
    Consent, Waiver and Amendment between Registrant and J. R. Hyde, III and Pittco
Associates, L.P. dated December 3, 2007(5)10.29
    *
    
    2011 Compensation Information for Registrants Executive Officers10.50
    *
    
    Non-Employee Director Compensation Policy of GTx, Inc., effective February 18, 201110.57
    
    
    Second Amendment to Sublease and Parking Sublicense Agreements dated January 1, 2011 by
and between the Registrant and ESS SUSA Holdings, LLC(6)10.58
    *
    
    Letter Agreement, dated February 25, 2011, between the Registrant and Ipsen Biopharm
Limited31.1
    *
    
    Certification of Chief Executive Officer, as required by Rule 13a-14(a) or Rule 15d-14(a)31.2
    *
    
    Certification of Chief Financial Officer, as required by Rule 13a-14(a) or Rule 15d-14(a)32.1
    *
    
    Certification of Chief Executive Officer, as required by Rule 13a-14(b) or Rule
15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18
U.S.C. §1350)(7)32.2
    *
    
    Certification of Chief Financial Officer, as required by Rule 13a-14(b) or Rule
15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18
U.S.C. §1350)(7)
 
 *
    
    Filed herewith.(1)
    
    Filed as Exhibit 4.1 to the Registrants registration statement on Form S-3 (File
No. 333-127175), filed with the SEC on August 4, 2005, and incorporated herein by reference.(2)
    
    Filed as the like numbered Exhibit to the Registrants Current Report on Form 8-K
(File No. 000-50549), filed with the SEC on May 6, 2011, and incorporated herein
by reference.(3)
    
    Filed as Exhibit 3.2 to the Registrants Current Report on Form 8-K
(File No. 000-50549), filed with the SEC on July 26, 2007, and incorporated herein
by reference.(4)
    
    Filed as the like numbered Exhibit to the Registrants registration statement on
Form S-1 (File No. 333-109700), initially filed with the SEC on October 15, 2003, as amended,
and incorporated herein by reference.(5)
    
    Filed as the like numbered Exhibit to the Registrants registration statement on
Form S-3 (File No. 333-148321), filed with the SEC on December 26, 2007, and incorporated
herein by reference.(6)
    
    Filed as the like numbered Exhibit to the Registrants Annual Report on Form 10-K
(File No. 000-50549), filed with the SEC on March 8, 2011, and
incorporated herein by reference.(7)
    
    This certification accompanies the Form 10-Q to which it relates, is not deemed
filed with the Securities and Exchange Commission and is not to be incorporated by reference
into any filing of the Registrant under the Securities Act of 1933, as amended, or the
Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form
10-Q), irrespective of any general incorporation language contained in such filing.  38