UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 10-Q
(Mark One)
 
x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the quarterly period ended: March 31, 2014
 
o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the transition period from ____________to _____________
 
Cellceutix Corporation
(Exact name of registrant as specified in its charter)
 
Commission File Number: 000-52321
 
Nevada
 
30-0565645
(State or other jurisdiction of incorporation or organization)
 
(I.R.S. Empl. Ident. No.)
 
100 Cumming Center, Suite 151-B
Beverly, MA 01915
(Address of principal executive offices, Zip Code)
 
(978)-236-8717
(Registrant’s telephone number, including area code)
 
__________________________________________________________________
(Former Name, Former Address and Former Fiscal Year if Changed Since Last Report)
 
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 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 o
 
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes  x No o
 
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
o
Accelerated Filer
x
Non-Accelerated Filer o Smaller reporting company o
(Do not check if a smaller reporting company)
   

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes  o No x
 
The number of shares outstanding of each of the issuer’s classes of common equity, as of May 7, 2014 is as follows:
 
Class of Securities
 
Shares Outstanding
Common Stock Class A, $0.001 par value
 
108,027,129

 
 
 
CELLCEUTIX CORPORATION
 UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 MARCH 31, 2014

PART I – FINANCIAL INFORMATION
Item 1.
Financial Statements (unaudited)
   4  
 
Condensed Consolidated Balance Sheets as of March 31, 2014 (unaudited) and June 30, 2013 (audited)
    4  
 
Condensed Consolidated Statements of Operations (unaudited) for the three months and nine months ended March 31, 2014 and 2013 and for the cumulative period from June 20, 2007 (Date of Inception) to March 31, 2014
    5  
 
Consolidated Statements of Changes in Stockholders’ Equity (Deficit) (unaudited) for the cumulative period from June 20, 2007 (Date of Inception) to March 31, 2014
    6  
 
Condensed Consolidated Statements of Cash Flows (unaudited) for the nine months ended March 31, 2014 and 2013 and for the cumulative period from June 20, 2007 (Date of Inception) to March 31, 2014
    10  
 
Notes to Condensed Consolidated Financial Statements (unaudited)
    12  
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
    26  
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
    33  
Item 4.
Controls and Procedures
    33  

PART II – OTHER INFORMATION
Item 1.
Legal Proceedings
    34  
Item 1A
Risk Factors
    34  
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
    49  
Item 3.
Defaults Upon Senior Securities
    49  
Item 4.
Mine Safety Disclosures
    49  
Item 5.
Other Information
    49  
Item 6.
Exhibits
    50  
           
SIGNATURES
    51  

 
2
 
 
FORWARD-LOOKING STATEMENTS
 
This report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, and Section 27A of the Securities Act of 1933. Any statements contained in this report that are not statements of historical fact may be forward-looking statements. When we use the words “ intends,” “estimates,” “predicts,” “potential,” “continues,” “anticipates,” “plans,” “expects,” “believes,” “should,” “could,” “may,” “will” or the negative of these terms or other comparable terminology, we are identifying forward-looking statements. Forward-looking statements involve risks and uncertainties, which may cause our actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. These factors include our; research and development activities, distributor channel; compliance with regulatory impositions; and our capital needs. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
 
Except as may be required by applicable law, we do not undertake or intend to update or revise our forward-looking statements, and we assume no obligation to update any forward-looking statements contained in this report as a result of new information or future events or developments. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. You should carefully review and consider the various disclosures we make in this report and our other reports filed with the Securities and Exchange Commission that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business.
 
For further information about these and other risks, uncertainties and factors, please review the disclosure included in this report under “Part I, Item 1A, Description of Business - Risk Factors.”
 
 
3
 

PART 1. FINANCIAL INFORMATION
 
ITEM 1. FINANCIAL STATEMENTS
 
CELLCEUTIX CORPORATION
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
 
   
March 31,
   
June 30,
 
   
2014
   
2013
 
   
(Unaudited)
   
(audited)
 
ASSETS
Current Assets:
           
Cash
  $ 5,147,881     $ 2,955,317  
Prepaid expenses and security deposits
    213,040       4,796  
Total Current Assets
    5,360,921       2,960,113  
                 
Other Assets:
               
Patent costs - net
    4,557,310       10,400  
Property, plant and equipment -net
    40,950       -  
Deferred offering costs
    342,774       -  
Total Other Assets
    4,941,034       10,400  
                 
Total Assets
  $ 10,301,955     $ 2,970,513  
                 
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIENCY)
                 
Current Liabilities:
               
Accounts payable - (including related party payables of $1,707,576 and $1,703,916, respectively)
  $ 1,818,323     $ 1,849,077  
Accrued expenses - (including related party accruals of $256,790 and $353,797, respectively)
    915,488       553,797  
Accrued salaries and payroll taxes -(including related party accrued salaries of $3,222,000 and $3,427,294, respectively)
    3,234,942       3,431,018  
Accrued settlement costs
    -       284,519  
Note payable - related party
    2,022,264       2,022,264  
Redeemable Common Stock
    1,400,000       -  
Total Current Liabilities
    9,391,017       8,140,675  
                 
Commitments and contingencies
               
                 
Stockholders' Equity (Deficiency)
               
Preferred stock, $0.001 par value, 500,000 designated shares, no shares issued and outstanding
    -       -  
Common Stock - Class A, $.0001 par value, 300,000,000 shares authorized, 107,112,129 issued and outstanding as of March 31, 2014 and 100,456,068 issued and 99,073,984 outstanding as of June 30, 2013
    10,711       10,046  
Common Stock - Class B, (10 votes per share); $.0001 par value, 100,000,000 shares authorized, no shares issued and outstanding as of March 31, 2014 & June 30, 2013, respectively
    -       -  
Additional paid-in capital
    25,580,323       14,868,223  
Deficit accumulated during the development stage
    (24,680,096 )     (19,773,202 )
Treasury stock - 0 and 1,382,084 shares at cost - as of March 31, 2014 and June 30, 2013, respectively
    -       (275,229 )
Total Stockholders' Equity (Deficiency)
    910,938       (5,170,162 )
                 
Total Liabilities and Stockholders' Equity (Deficiency)
  $ 10,301,955     $ 2,970,513  
 
The accompanying notes are an integral part of these condensed unaudited financial statements
 
 
4
 
 
CELLCEUTIX CORPORATION
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)

                            For the  
                           
cumulative
 
                           
period from
 
                           
June 20, 2007
 
                           
(Date of
 
                           
Inception)
 
   
For the Three Months Ended
   
For the Nine Months Ended
   
through
 
   
March 31,
   
March 31,
   
March 31,
 
   
2014
   
2013
   
2014
   
2013
   
2014
 
                               
Revenues
  $ -     $ -     $ -     $ -     $ -  
                                         
Operating expenses:
                                       
Research and development, gross
    1,831,373       543,115       3,417,149       1,009,584       10,024,042  
Grants
    -       -       -       -       (733,438 )
Research and development, net of grants
    1,831,373       543,115       3,417,149       1,009,584       9,290,604  
General and administrative expenses
    126,663       33,388       561,838       85,675       1,466,470  
Officers' payroll and payroll tax expense
    138,212       125,372       375,582       353,321       8,428,144  
Professional fees
    79,573       98,566       286,105       420,454       3,479,985  
Patent expense
    107,000       310       107,000       29,369       304,724  
                                         
Total operating expenses
    2,282,821       800,751       4,747,674       1,898,403       22,969,927  
                                         
Loss from operations
    (2,282,821 )     (800,751 )     (4,747,674 )     (1,898,403 )     (22,969,927 )
                                         
Other income (expenses)
                                       
Interest income
    -       -       432       -       432  
Interest expense
    (50,557 )     (65,799 )     (159,652 )     (185,959 )     (984,142 )
Loss on financial instruments
    -       -       -       -       (439,892 )
Total other expenses
    (50,557 )     (65,799 )     (159,220 )     (185,959 )     (1,423,602 )
                                         
Net loss before provision for income taxes
    (2,333,378 )     (866,550 )     (4,906,894 )     (2,084,362 )     (24,393,529 )
Provision for income taxes
    -       -       -       -       -  
                                         
Net loss
  $ (2,333,378 )   $ (866,550 )   $ (4,906,894 )   $ (2,084,362 )   $ (24,393,529 )
                                         
Deemed dividends
    -       -       (1,979,706 )     (211,802 )     (2,257,194 )
Net loss attributable to common stockholders
  $ (2,333,378 )   $ (866,550 )   $ (6,886,600 )   $ (2,296,164 )   $ (26,650,723 )
                                         
Basic and diluted loss per share attributable to common stockholders
  $ (0.02 )   $ (0.01 )   $ (0.07 )   $ (0.02 )        
                                         
Weighted average number of common shares
    106,542,850       96,091,495       103,935,184       94,016,785          
 
The accompanying notes are an integral part of these unaudited condensed financial statements.

 
5
 
CELLCEUTIX CORPORATION
(A Development Stage Enterprise)
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
For the cumulative
Period June 20, 2007 (Date of Inception)
through March 31, 2014
 
   
Preferred Stock
   
Common Stock
   
Additional
   
Deficit
Accumulated
During the
             
         
Par Value
         
Par Value
   
Paid-in
   
Development
   
Treasury Stock
       
   
Shares
    $ 0.001    
Shares
    $ 0.0001    
Capital
   
Stage
   
Shares
   
Amount
   
Total
 
                                                           
Shares issued June 20, 2007
                                                         
(Inception)
    -     $ -       1,000,000     $ 100     $ -     $ -       -     $ -     $ 100  
                                                                         
Net loss
    -       -       -       -       -       (530 )     -       -       (530 )
Balance at June 30, 2007 - audited
    -       -       1,000,000       100       -       (530 )     -       -       (430 )
                                                                         
Share exchange with
                                                                       
Cellceutix Pharma, Inc.
                                                                       
December 6, 2007
    -       -       (1,000,000 )     (100 )     -       100       -       -       -  
                                                                         
Share exchange in reverse
                                                                       
merger with Cellceutix
                                                                       
Pharma, Inc.
                                                                       
December 6,2007
    -       -       82,000,000       8,200       -       (8,200 )     -       -       -  
                                                                         
Shares exchanged in a reverse
                                                                       
acquisition of Cellceutix
                                                                       
Pharma, December 6, 2007
    -       -       9,791,000       979       -       (979 )     -       -       -  
                                                                         
Issuance of stock options
    -       -       -       -       43,533       -       -       -       43,533  
                                                                         
Forgiveness of debt from a
                                                                       
stockholder
    -       -       -       -       50       -       -       -       50  
                                                                         
Capital contribution from a
                                                                       
stockholder
    -       -       -       -       50       -       -       -       50  
                                                                         
Shares issued for services,
                                                                       
April 28, 2008 at $1.05
    -       -       100,000       10       104,990       -       -       -       105,000  
                                                                         
Net loss
    -       -       -       -       -       (510,193 )     -       -       (510,193 )
Balance at June 30, 2008 - audited
    -       -       91,891,000       9,189       148,623       (519,802 )     -       -       (361,990 )
                                                                         
Cancellation of shares issued
                                                                       
for services, December 31, 2008
    -       -       (100,000 )     (10 )     (104,990 )     -       -       -       (105,000 )
                                                                         
Issuance of stock options
    -       -       -       -       142,162       -       -       -       142,162  
                                                                         
Shares issued for services,
                                                                       
June 11, 2009 at $0.38
    -       -       20,000       2       7,598       -       -       -       7,600  
                                                                         
Shares issued for services,
                                                                       
June 30, 2009 at $0.38
    -       -       25,000       3       9,497       -       -       -       9,500  
                                                                         
Net loss
    -       -       -       -       -       (1,485,331 )     -       -       (1,485,331 )
Balance at June 30, 2009 - audited
    -       -       91,836,000       9,184       202,890       (2,005,133 )     -       -       (1,793,059 )
 
 
6
 
 
   
Preferred Stock
   
Common Stock
   
Additional
   
Deficit
Accumulated
During the
             
         
Par Value
         
Par Value
   
Paid-in
   
Development
   
Treasury Stock
       
   
Shares
    $ 0.001    
Shares
    $ 0.0001    
Capital
   
Stage
   
Shares
   
Amount
   
Total
 
                                                       
Shares issued for services,                                                      
July 6, 2009 at $0.43   -     -     25,000     2     10,748     -     -     -      10,750  
                                                       
Shares issued for services,
                                                                       
February 5, 2010 at $0.30
    -       -       3,500       -       1,050       -       -       -       1,050  
                                                                         
Issuance of stock options
    -       -       -       -       383,291       -       -       -       383,291  
                                                                         
Shares issued for services
                                                                       
June 1, 2010 at $0.45
    -       -       75,000       8       33,742       -       -       -       33,750  
                                                                         
Net loss
    -       -       -       -       -       (3,433,400 )     -       -       (3,433,400 )
Balance at June 30, 2010 - audited
    -       -       91,939,500       9,194       631,721       (5,438,533 )     -       -       (4,797,618 )
                                                                         
Shares issued for services,
                                                                       
July 6, 2010 at $0.55
    -       -       50,000       5       27,495       -       -       -       27,500  
                                                                         
Cancellation of shares issued
    -       -       (75,000 )     (8 )     (33,742 )     -       -       -       (33,750 )
                                                                         
Issuance of stock options
    -       -       -       -       3,060,691       -       -       -       3,060,691  
                                                                         
Modification of stock options
    -       -       -       -       237,098       -       -       -       237,098  
                                                                         
Forgiveness of liability in
                                                                       
connection with settlement
                                                                       
with stockholder
    -       -       -       -       932,966       -       -       -       932,966  
                                                                         
Repurchase of common stock
                                                                       
in connection with settlement
    -       -       -       -       -       -       4,602,313       (859,388 )     (859,388 )
                                                                         
Shares issued for services,
                                                                       
March 1, 2011 at $0.32
    -       -       184,375       18       58,982       -       -       -       59,000  
                                                                         
Shares issued for services,
                                                                       
February 8, 2011 at $0.20
    -       -       70,000       7       13,993       -       -       -       14,000  
                                                                         
Cancellation of treasury stock
    -       -       (460,229 )     (45 )     (99,955 )     -       (460,229 )     100,000       -  
                                                                         
Shares issued for services,
                                                                       
May 26, 2011 at $0.81
    -       -       12,000       1       9,719       -       -       -       9,720  
                                                                         
Net loss
    -       -       -       -       -       (5,938,297 )     -       -       (5,938,297 )
Balance at June 30, 2011 - audited
    -       -       91,720,646       9,172       4,838,968       (11,376,830 )     4,142,084       (759,388 )     (7,288,078 )
                                                                         
Issuance of stock options
    -       -       -       -       2,114,386       -       -       -       2,114,386  
                                                                         
Convertible debentures converted to common stock
    -       -       707,277       71       353,564       -       -       -       353,635  
                                                                         
Shares issued for services, August 29, 2011 at $0.38
    -       -       100,000       10       37,990       -       -       -       38,000  
                                                                         
Shares issued for services, November 8, 2011 at $0.41
    -       -       125,000       13       51,236       -       -       -       51,249  
                                                                         
Shares issued for services, January 11, 2012 at $0.45
    -       -       200,000       20       89,980       -       -       -       90,000  
                                                                         
Shares issued for charitable contributions, March 7
                                                                       
2012 at $0.52
    -       -       265,228       26       137,894       -       -       -       137,920  
                                                                         
Shares issued for services, April 26, 2012 at $0.46
    -       -       300,000       30       137,970       -       -       -       138,000  
                                                                         
Shares issued for services, May 3, 2012 at $0.49
    -       -       100,000       10       48,990       -       -       -       49,000  
                                                                         
Shares issued for services, May 29, 2012 at $0.53
    -       -       25,000       2       13,248       -       -       -       13,250  
                                                                         
Shares issued for services, June 29, 2012 at $0.62
    -       -       50,000       5       31,145       -       -       -       31,150  
                                                                         
Issuance of capital stock
    -       -       2,500,000       250       582,143       -       -       -       582,393  
                                                                         
Reclassification of warrants into equity
    -       -       -       -       857,500       -       -       -       857,500  
 
 
7
 
 
   
Preferred Stock
   
Common Stock
   
Additional
   
Deficit
Accumulated
During the
             
         
Par Value
         
Par Value
   
Paid-in
   
Development
   
Treasury Stock
       
   
Shares
    $ 0.001    
Shares
    $ 0.0001    
Capital
   
Stage
   
Shares
   
Amount
   
Total
 
                                                       
Cancellation of treasury stock
    -       -       (1,380,000 )     (138 )     (231,517 )     -       (1,380,000 )     231,655       -  
                                                                         
Issuance of preferred stock
    10,000       10       -       -       99,990       -       -       -       100,000  
                                                                         
Deemed dividend's
    -       -       -       -       65,686       (65,686 )     -       -       -  
                                                                         
Conversion of preferred stock to common stock
    (10,000 )     (10 )     255,754       26       (16 )     -       -       -       -  
                                                                         
Net loss
    -       -       -       -       -       (4,894,402 )     -       -       (4,894,402 )
Balance at June 30, 2012 - audited
    -     $ -       94,968,905     $ 9,497     $ 9,229,157     $ (16,336,918 )     2,762,084     $ (527,733 )   $ (7,625,997 )
                                                                         
Issuance of stock options
    -       -       -       -       217,047       -       -       -       217,047  
                                                                         
Shares issued for services, July 25, 2012 at $0.59
    -       -       25,000       3       14,747       -       -       -       14,750  
                                                                         
Shares issued for services, August 26, 2012 at $0.60
    -       -       50,000       5       29,995       -       -       -       30,000  
                                                                         
Shares issued for services, October 24, 2012 at $0.87
    -       -       50,000       5       43,495       -       -       -       43,500  
                                                                         
Shares issued as commitment fee, December 6, 2012 at $0.89
    -       -       336,625       34       299,967       -       -       -       300,001  
                                                                         
Offering cost
    -       -       -       -       (168,528 )     -       -       -       (168,528 )
                                                                         
Shares sold, December 6, 2012 at $0.89, net of offering costs of $3,000
    -       -       112,208       11       96,989       -       -       -       97,000  
                                                                         
Shares sold in March 2013 at $1.45-$1.54, net of offering costs of $45,490
    -       -       1,000,000       100       1,470,730       -       -       -       1,470,830  
                                                                         
Shares sold in May and June 2013 at $1.58-$1.97, net of offering costs of $82,983
    -       -       1,600,000       160       2,682,957       -       -       -       2,683,117  
                                                                         
Shares issued for charity donation, May 31, 2013 at $2.2
    -       -       100,000       10       219,990       -       -       -       220,000  
                                                                         
Exercise of stock options
    -       -       2,255,000       225       278,225       -       -       -       278,450  
                                                                         
Exercise of warrants
    -       -       741,000       74       185,176       -       -       -       185,250  
                                                                         
Issuance of preferred stock
    30,000       30       -       -       299,970       -       -       -       300,000  
                                                                         
Cancellation of treasury stock
    -       -       (1,380,000 )     (138 )     (252,366 )     -       (1,380,000 )     252,504       -  
                                                                         
Deemed dividends
    -       -       -       -       211,802       (211,802 )     -       -       -  
                                                                         
Conversion of preferred stock to common stock
    (30,000 )     (30 )     592,330       59       (29 )     -       -       -       -  
                                                                         
Shares issued for services, June 30, 2013 at $1.78
    -       -       5,000       1       8,899       -       -       -       8,900  
                                                                         
Net loss
    -       -       -       -       -       (3,224,482 )     -       -       (3,224,482 )
Balance at June 30, 2013 - audited
    -     $ -       100,456,068     $ 10,046     $ 14,868,223     $ (19,773,202 )     1,382,084     $ (275,229 )   $ (5,170,162 )
                                                                         
Issuance of stock options
    -       -       -       -       53,952       -       -       -       53,952  
                                                                         
Exercise of warrants - July 1, 2013 - March 31, 2014
    -       -       2,073,084       207       1,624,793                               1,625,000  
                                                                         
Cancellation of treasury stock
    -       -       (1,382,083 )     (138 )     (275,091 )     -       (1,382,084 )     275,229       -  
                                                                         
Shares sold during July, 2013 to September, 2013 at $1.66-$1.94
    -       -       2,100,000       210       3,730,130       -       -       -       3,730,340  
                                                                         
Shares issued for assets of Polymedix at $1.93
    -       -       1,400,000       140       1,301,860       -       -       -       1,302,000  
                                                                         
Shares sold during October, 2013 to December, 2013 at $1.66-$1.78
    -       -       1,104,537       110       1,887,130       -       -       -       1,887,240  
                                                                         
Shares issued to employees for year ended bonus at $1.85 for 5,000 shares and $1.6 for 60,000 shares
                    65,000       7       105,243       -       -       -       105,250  
 
 
8
 
 
   
Preferred Stock
   
Common Stock
   
Additional
   
Deficit
Accumulated
During the
             
         
Par Value
         
Par Value
   
Paid-in
   
Development
   
Treasury Stock
       
   
Shares
    $ 0.001    
Shares
    $ 0.0001    
Capital
   
Stage
   
Shares
   
Amount
   
Total
 
                                                                         
Shares issued to consultants at $2.09
                    50,000       5       104,495       -       -       -       104,500  
                                                                         
Shares issued for offering cost at $1.77
                    210,523       21       372,605       -       -       -       372,626  
                                                                         
Shares sold during January, 2014 to March, 2014 at $1.64-$1.82
    -       -       900,000       90       1,602,710       -       -       -       1,602,800  
                                                                         
Shares issued to consultants at $1.64-$1.79
                    110,000       11       200,139       -       -       -       200,150  
                                                                         
Offering cost
    -       -       -       -       (29,852 )     -       -       -       (29,852 )
                                                                         
Exercise of options
    -       -       25,000       2       4,998       -       -       -       5,000  
                                                                         
Issuance of stock options
                                    28,988                               28,988  
                                                                         
Net loss - nine months ended March 31, 2014
    -       -       -       -       -       (4,906,894 )     -       -       (4,906,894 )
Balance at March 31, 2014 - unaudited
    -     $ -       107,112,129     $ 10,711     $ 25,580,323     $ (24,680,096 )     -     $ -     $ 910,938  
 
The accompanying notes are an integral part of these unaudited condensed financial statements.
 
 
9
 
CELLCEUTIX CORPORATION
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)

               
For the
 
               
cumulative
 
               
period from
 
               
June 20, 2007
 
               
(Date of
 
         
Inception)
 
    For the Nine Months Ended      through   
    March 31,    
 March 31
 
   
2014
   
2013
   
2014
 
                   
CASH FLOWS FROM OPERATING ACTIVITIES:
                 
Net loss
  $ (4,906,894 )   $ (2,084,362 )   $ (24,393,529 )
Adjustments to reconcile net loss to net cash used in operating activities:
                       
Loss on disposal of fixed assets
    72,400       -       72,400  
Common stock and stock options issued as payment for services compensation, services rendered, and
                    -  
charitable contributions and financing costs
    492,839       258,463       7,701,404  
Cancellation of stock issued for services
    -       -       (28,750 )
Amortization of accrued settlement costs
    -       33,042       125,131  
Amortization of patent costs
    195,788       554       196,404  
Depreciation of equipment
    2,067       -       2,067  
                         
Loss on financial instruments
    -       -       439,892  
Changes in operating assets and liabilities:
                       
Prepaid expenses
    (208,244 )     (7,131 )     (204,555 )
Accounts payable
    (30,754 )     16,205       1,818,372  
Accrued expenses
    361,691       116,635       1,147,649  
Accrued officers' salaries and payroll taxes
    (196,076 )     642,401       4,167,907  
                         
Net cash used in operating activities
    (4,217,183 )     (1,024,193 )     (8,955,608 )
                         
CASH FLOWS FROM INVESTING ACTIVITIES:
                       
Proceeds from disposal of fixed assets
    23,600       -       23,600  
Additions to property, plant and equipment
    (43,017 )     -       (43,017 )
Patent costs
    (2,136,697 )     (4,238 )     (2,147,713 )
                         
Net cash used in investing activities
    (2,156,114 )     (4,238 )     (2,167,130 )
                         
CASH FLOWS FROM FINANCING ACTIVITIES:
                       
Capital contribution from stockholder
    -       -       50  
Sale of common stock
    7,220,380       1,616,320       11,602,900  
Sale of preferred stock
    -       300,000       400,000  
Payment of settlement liabilities
    (284,519 )     (300,000 )     (984,519 )
Loan from officer
    -       -       1,925,587  
Proceeds from convertible debentures
    -       -       (167,099 )
Redemption of convertible debentures
    -       -       400,000  
Proceeds from subscription
    -       -       1,000,000  
Exercise of stock options and warrants
    1,630,000       462,450       2,093,700  
                         
Net cash provided by financing activities
    8,565,861       2,078,770       16,270,619  
                         
NET INCREASE IN CASH AND CASH EQUIVALENTS
    2,192,564       1,050,339       5,147,881  
                         
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
    2,955,317       27,703       -  
                         
CASH AND CASH EQUIVALENTS, END OF PERIOD
  $ 5,147,881     $ 1,078,042     $ 5,147,881  
                         
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
                 
Cash paid for interest
  $ 252,159     $ 25,909     $ 558,188  
 
 
10
 
 
     
For the Nine Months Ended
March 31,
     
For the
cumulative
period from
June 20, 2007
(Date of
Inception)
through
March 31,
 
     
2014
     
2013
     
2014
 
                         
SUPPLEMENTAL DISCLOSURE OF NON-CASH FLOW
                       
FINANCING ACTIVITIES
                       
Common stock issued for acquisition
  $ -     $ -     $ 9,079  
Forgiveness of debt
  $ -     $ -     $ 50  
Reclassification of accrued interest to note payable
                       
and convertible debentures
  $ -     $ -     $ 197,964  
Cancellation of common stock for services
  $ -     $ -     $ (138,750 )
Settlement of accrued payroll and payroll taxes
  $ -     $ -     $ 932,966  
Cancellation of common stock as a result of settlement
  $ -     $ -     $ 859,388  
Debt converted to common stock
  $ -     $ -     $ 353,635  
Cancellation of treasury stock
  $ (275,229 )    $ (252,504 )   $ (759,388 )
Reclassification of warrants to equity
  $ -     $ -     $ 857,500  
Deemed dividend from beneficial conversion feature on preferred stock
  $ -     $ 53,032     $ 70,678  
Deemed dividend - warrants
  $ 1,979,706     $ 158,770     $ 2,186,516  
Conversion of preferred stock into common stock
  $ -     $ (30 )   $ (46 )
Shares issued as deferred offering costs
  $ 372,605     $ 300,001     $ 672,606  
Shares issued for acquisition of patent and equipment
  $ 2,702,000     $ -     $ 2,702,000  
Redeemable common stock
  $ 1,400,000     $ -     $ 1,400,000  
 
The accompanying notes are an integral part of these unaudited condensed financial statements.
 
 
11
 
 
CELLCEUTIX CORPORATION
(A Development Stage Enterprise)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2014
(Unaudited)

1. Basis of Presentation and Nature of Operations

Basis of Presentation
 
The accompanying unaudited condensed consolidated financial statements of Cellceutix Corporation have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission, or the SEC, including the instructions to Form 10-Q and Regulation S-X. Certain information and note disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles in the United States of America have been condensed or omitted from these statements pursuant to such rules and regulations and, accordingly, they do not include all the information and notes necessary for comprehensive consolidated financial statements and should be read in conjunction with our audited financial statements for the year ended June 30, 2013, included in our Annual Report on Form 10-K for the year ended June 30, 2013.

In the opinion of the management of the Company, all adjustments, which are of a normal recurring nature, necessary for a fair statement of the results for the three month periods have been made. Results for the interim periods presented are not necessarily indicative of the results that might be expected for the entire fiscal year. When used in these notes, the terms "Company", "we", "us" or "our" mean Cellceutix Corporation. 

Cellceutix Corporation, formerly known as EconoShare, Inc., (“Cellceutix” or the “Company”) was incorporated on August 1, 2005. On December 6, 2007, the Company acquired Cellceutix Pharma, Inc. which was incorporated in the State of Delaware on June 20, 2007, in exchange for newly issued shares of the Company’s common stock. As a result of the exchange, Cellceutix Pharma, Inc. became a wholly-owned subsidiary of the Company. The Company is a clinical stage biopharmaceutical company and has no customers, products or revenues to date. Accordingly, the accompanying financial statements have been prepared in accordance with generally accepted accounting principles related to development-stage companies as set forth in Financial Accounting Standards Board Accounting Standards Codification 915 (“FASB ASC 915”). A development-stage company is one in which planned principal operations have not commenced or if its operations have commenced, there has been no significant revenues there from.

The Company’s Common Stock is quoted on the Over the Counter Bulletin Board (OTCBB), symbol “CTIX”.

All amounts, where it is designated in these notes to the financial statements as an approximate amount, are rounded to the nearest thousand dollars.
 
Nature of Operations

Overview

We are in the business of developing innovative small molecule therapies to treat diseases with significant medical need, particularly in the areas of cancer and inflammatory disease. Our strategy is to use our business and scientific expertise to maximize the value of our pipeline. We will do this by focusing on our lead compounds, Kevetrin, Prurisol and Brilacidin, and advancing them as quickly as possible along the regulatory pathway. We will develop the highest quality data and broadest intellectual property to support our compounds.

We currently own all development and marketing rights to our products. In order to successfully develop and market our products, we may have to partner with other companies. Prospective partners may require that we grant them significant development and/or commercialization rights in return for agreeing to share the risk of development and/or commercialization.

 
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2. Going Concern
 
The accompanying financial statements have been prepared assuming the Company will continue as a going concern. For the period since June 20, 2007 (date of inception) through March 31, 2014, the Company has had a cumulative net loss attributable to common stockholders of approximately $26.6 million and a working capital deficit of approximately $4.0 million at March 31, 2014. As of March 31, 2014, the Company has not emerged from the development stage. In view of these matters, the ability of the Company to continue as a going concern is dependent upon the Company’s ability to generate additional financing. Since inception, the Company has financed its activities principally from the use of equity securities, debt issuance and loans from an officer to pay for its operations. The Company intends on financing its future development activities and its working capital needs largely from the issuance of debt and the sale of equity securities, until such time that funds provided by operations are sufficient to fund working capital requirements. On October 25, 2013, we terminated a previous agreement with Aspire Capital Fund, LLC, an Illinois limited liability company (“Aspire Capital”), and entered into a new stock purchase agreement (the “Purchase Agreement”) with Aspire Capital.
 
The Purchase Agreement provides that upon meeting the terms of the agreement, Aspire Capital is committed to purchase up to an aggregate of $20,000,000 of our shares of Class A Common Stock over the approximately 36-month term of the Purchase Agreement. In consideration for entering into the Purchase Agreement, the Company issued to Aspire Capital 210,523 shares of its Class A Common Stock as a commitment fee. The commitment fee will be amortized as the funding is received. The unamortized portion is carried on the balance sheet as deferred offering costs. Concurrently with entering into the Purchase Agreement, the Company agreed to file one or more registration statements as permissible and necessary under the Securities Act of 1933, as amended, or the Securities Act, for the sale of shares of our Class A Common Stock that have been and may be issued to Aspire Capital under the Purchase Agreement. On November 4, 2013, the Company filed a Form S-3 registration statement and the registration statement was declared effective by the SEC on November 15, 2013.
 
These factors raise substantial doubt about the Company's ability to continue as a going concern. The accompanying financial statements do not include any adjustments relating to the recoverability of the recorded assets or the classification of liabilities that may be necessary should the Company be unable to continue as a going concern.
 
3. Significant Accounting Policies and Recent Accounting Pronouncements

Cash and Cash Equivalents
 
Cash and cash equivalents consist of cash and short-term highly liquid investments purchased with original maturities of three months or less. There were no cash equivalents at March 31, 2014 and June 30, 2013.
 
Property, plant and Equipment
 
Property and equipment are stated at cost, net of accumulated depreciation. Expenditures that extend the life, increase the capacity, or improve the efficiency of property and equipment are capitalized, while expenditures for repairs and maintenance are expensed as incurred. Depreciation is recognized using the straight-line method over the following approximate useful lives:

Depreciation is recognized using the straight-line method over the following approximate useful lives:
 
Machinery and equipment 5 Years
 
Intangible Assets – Patents
 
Costs incurred to file patent applications and acquired intangibles are capitalized when the Company believes that there is a high likelihood that the patent will be issued and there will be future economic benefit associated with the patent. These costs will be amortized on a straight-line basis over a 12 - 17 years life from the date of patent filing. All costs associated with abandoned patent applications are expensed. In addition, the Company will review the carrying value of patents for indicators of impairment on a periodic basis and if it determines that the carrying value is impaired, it values the patent at fair value. Costs incurred to file patent applications and acquire intangibles are expensed when the patents have failed to develop products which have gained market acceptance. For the three months ended March 31, 2014 and 2013, the Company has charged to operations $107,000 and $0, respectively, for these patent application costs. For the nine months ended March 31, 2014 and 2013 and from inception to March 31, 2014, the Company has charged to operations approximately $107,000, $29,000, and $305,000, respectively, for these patent application costs.

 
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In accordance with the provisions of the applicable authoritative guidance, the Company’s long-lived assets and amortizable intangible assets are tested for impairment whenever events or changes in circumstances indicate that their carrying value may not be recoverable. The Company assesses the recoverability of such assets by determining whether their carrying value can be recovered through undiscounted future operating cash flows, including its estimates of revenue driven by assumed market segment share and estimated costs. If impairment is indicated, the Company measures the amount of such impairment by comparing the fair value to the carrying value. During the three and nine months ended March 31, 2014 and 2013, no impairment expense was recorded.
 
Financial Instruments
 
The Company’s financial instruments include cash, accounts payable and accrued liabilities. The carrying amounts of these financial instruments approximate their fair value, due to the short-term nature of these items.

Use of Estimates
 
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and 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. Actual results could differ from those estimates.
 
Significant Estimates

These accompanying consolidated financial statements include some amounts that are based on management’s best estimates and judgments. The most significant estimates relate to valuation of stock grants and stock options, valuation of purchased intangibles and the valuation allowance on deferred tax assets. It is reasonably possible that these above-mentioned estimates and others may be adjusted as more current information becomes available, and any adjustment could be significant in future reporting periods.

Certain Risks and Uncertainties

Product Development

We devote significant resources to research and development programs in an effort to discover and develop potential future product candidates. The product candidates in our pipeline are at various stages of preclinical and clinical development. The path to regulatory approval includes three phases of clinical trials in which we collect data to support an application to regulatory authorities to allow us to market a product for treatment of a specified disease. There are many difficulties and uncertainties inherent in research and development of new products, resulting in a high rate of failure. To bring a drug from the discovery phase to regulatory approval, and ultimately to market, takes many years and significant cost. Failure can occur at any point in the process, including after the product is approved, based on post-market factors. New product candidates that appear promising in development may fail to reach the market or may have only limited commercial success because of efficacy or safety concerns, inability to obtain necessary regulatory approvals, limited scope of approved uses, reimbursement challenges, difficulty or excessive costs of manufacture, alternative therapies or infringement of the patents or intellectual property rights of others. Uncertainties in the FDA approval process and the approval processes in other countries can result in delays in product launches and lost market opportunities. Consequently, it is very difficult to predict which products will ultimately be submitted for approval, which have the highest likelihood of obtaining approval and which will be commercially viable and generate profits. Successful results in preclinical or clinical studies may not be an accurate predictor of the ultimate safety or effectiveness of a drug or product candidate.

Expenditures for research, development, and engineering of products are expensed as incurred. In November 2010, the Company was awarded three separate U.S. government grants under the Qualifying Therapeutic Discovery Project (QTDP) program. For the period from inception to March 31, 2014, the Company has reflected approximately $733,000 of grants as a one time reduction of research and development expenses. For the three months ended March 31, 2014 and 2013, the Company incurred approximately $1,831,000 and $543,000 of research and development costs, net of grants respectively. For the nine months ended March 31, 2014 and 2013, and the period from inception to March 31, 2014, the Company incurred approximately $3,417,000, $1,010,000, and $9,291,000 of research and development costs, net of grants, respectively.

 
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Concentrations of Credit Risk
 
All cash is maintained with a major financial institution in the United States. Deposits with this bank may exceed the amount of insurance provided on such deposits. Generally, these deposits may be redeemed upon demand and, therefore, bear minimal risk.

Income Taxes
 
Deferred income tax assets and liabilities arise from temporary differences associated with differences between the financial statements and tax basis of assets and liabilities, as measured by the enacted tax rates, which are expected to be in effect when these differences reverse. Deferred tax assets and liabilities are classified as current or non-current, depending upon the classification of the asset or liabilities to which they relate. Deferred tax assets and liabilities not related to an asset or liability are classified as current or non-current depending on the periods in which the temporary differences are expected to reverse. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.
 
The Company has generated net losses since inception and accordingly has not recorded a provision for income taxes. The deferred tax assets were primarily comprised of federal and state tax net operating loss, or NOL, carryforwards. Due to uncertainties surrounding the Company’s ability to generate future taxable income to realize these tax assets, a full valuation allowance has been established to offset the deferred tax assets. Additionally, the future utilization of the NOL carryforwards to offset future taxable income may be subject to an annual limitation as a result of ownership changes that could occur in the future. If necessary, the deferred tax assets will be reduced by any carryforwards that expire prior to utilization as a result of such limitations, with a corresponding reduction of the valuation allowance.
 
The Company follows the provisions of FASB ASC 740-10 "Uncertainty in Income Taxes" (ASC 740-10). The Company has not recognized a liability as a result of the implementation of ASC 740-10. A reconciliation of the beginning and ending amount of unrecognized tax benefits has not been provided since there is no unrecognized benefit since the date of adoption. The Company has not recognized interest expense or penalties as a result of the implementation of ASC 740-10. If there were an unrecognized tax benefit, the Company would recognize interest accrued related to unrecognized tax benefits in interest expense and penalties in operating expenses.
 
The Company has identified its U.S. Federal income tax return and its State return in Massachusetts as its major tax jurisdictions. The fiscal 2011 and forward years are still open for a tax examination.
 
Basic Earnings (Loss) per Share
 
Basic and diluted earnings per share are computed based on the weighted-average common shares and common share equivalents outstanding during the period. Common share equivalents consist of stock options, warrants and convertible notes payable. Common share equivalents of approximately 47.1 million and 50 million were excluded from the computation of diluted earnings per share as of March 31, 2014 and 2013, respectively, and have been excluded from the per share computations for the three and nine months ended March 31, 2014 and 2013, because their effect is anti-dilutive.
 
Accounting for Stock Based Compensation

The stock-based compensation expense incurred by Cellceutix for employees and directors in connection with its stock option plan is based on the employee model of ASC 718, and the fair market value of the options is measured at the grant date. Under ASC 718 employee is defined as “An individual over whom the grantor of a share-based compensation award exercises or has the right to exercise sufficient control to establish an employer-employee relationship based on common law as illustrated in case law and currently under U.S.“tax regulations”. Our consultants do not meet the employer-employee relationship as defined by the IRS and therefore are accounted for under ASC 505-50.

 
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ASC 505-50-30-11 (previously EITF 96-18) further provides that an issuer shall measure the fair value of the equity instruments in these transactions using the stock price and other measurement assumptions as of the earlier of the following dates, referred to as the measurement date:

i. 
The date at which a commitment for performance by the counterparty to earn the equity instruments is reached (a performance commitment); and

ii. 
The date at which the counterparty’s performance is complete.

We have elected to use the Black-Scholes-Merton pricing model to determine the fair value of stock options on the dates of grant. Restricted stock units are measured based on the fair market values of the underlying stock on the dates of grant. We recognize stock-based compensation using the straight-line method.

The components of stock based compensation recognized in the Company’s Statement of Operations for the three and nine months ended March 31, 2014 and 2013 and since inception are as follows(rounded to nearest thousand):
 
   
Three Months
Ended
March 31,
2014
   
Three Months
Ended
March 31,
2013
   
Nine Months
Ended
March 31,
2014
   
Nine Months
Ended
March 31,
2013
   
For the cumulative period
from June 20,
2007
(Date of Inception) through
March 31,
2014
 
                               
Employee’s stock compensation
  $ -     $ -     $ 105,000     $ -     $ 105,000  
Officers’ stock compensation
    -       -       -       -       4,925,000  
Consulting
    237,000       44,000       388,000      
258,000
      2,266,000  
Patent expense
    -       -       -       -       19,000  
Charitable contribution
    -       -       -       -       358,000  
Total
  $ 237,000     $ 44,000     $ 493,000     $
258,000
    $ 7,673,000  

Total stock-based compensation and stock issued for financing costs and charitable contributions totaled approximately $7.7 million from inception to March 31, 2014.

Recent Accounting Pronouncements

In April 2014, we adopted the Financial Accounting Standards Board’s (“FASB”) Accounting Standards Update No (ASU 2014-08), “Reporting Discontinued Operations and Disclosures of Disposals of Components of an Entity”. ASU 2014-08 on Discontinued Operations changes the criteria for determining which disposals can be presented as discontinued operations and modified related disclosure requirements. Under the new guidance, a discontinued operation is defined as: (i) a disposal of a component or group of components that is disposed of or is classified as held for sale that represents a strategic shift that has or will have a major effect on an entity’s operations and financial results or (ii) an acquired business or nonprofit activity that is classified as held for sale on the date of acquisition. The standard states that a strategic shift could include a disposal of (i) a major geographical area of operations, (ii) a major line of business, (iii) a major equity method investment, or (iv) other major parts of an entity. Under the current US GAAP, an entity is prohibited from reporting a discontinued operation if it has certain continuing cash flows or involvement component after the disposal. The new guidance eliminates these criteria.

The Company does not expect the adoption of any recent accounting pronouncements to have a material impact on its financial statements.

 
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4. Polymedix Inc. Asset Acquisition –Patent Rights and Equipment

On September 4, 2013, the Company purchased substantially all of the assets (“Purchased Assets”) of Polymedix Inc, and Polymedix Pharmaceuticals, Inc. (“Seller”) from the U.S. Bankruptcy Court.

The aggregate purchase price for the sale and transfer of the Purchased Assets was $2.1 million in cash, plus 1.4 million shares of the Company’s Class A common stock (the “Registrable Securities”), for a total aggregate purchase price of approximately $4.8 million. These common shares were valued at $1.93 per share, based on the September 4, 2013 opening stock price as quoted on the OTB Bulletin Board, resulting in approximately $2.7 million of stock issued to acquire the Purchased Assets. The Purchased Assets Agreement also provides the Seller with the right to require the Company to redeem the Common Stock held by such Seller (the “Put Option”) at any time between one day after the closing and three hundred and sixty-five days after the closing, the seller or any holder of the registrable securities may make written demand upon the purchase for the purchase to repurchase the registrable securities for $1 per share.

Because the Company is required to repurchase these issued common shares if the Seller exercises the above Put Option, this redemption feature meets the definition under the ASC 480-10-25-8, “Obligations to Repurchase Issuer’s Equity Shares by Transferring Assets”. Per ASC 480-10-25-8, the obligation to repurchase an issuer’s own shares by transferring assets should be recognized as a liability at inception date. Therefore, the number of potential shares needed to repurchase the Common Stock under this Put Option was 1,400,000 shares as of December 31, 2013. This obligation was recorded as a current liability of $1.4 million of Redeemable Common Stock liability in the accompanying balance sheet.

ASC 805, Business Combinations, provides guidance on determining whether an acquired set of assets meets the definition of a business for accounting purposes. Under the framework, the acquired set of activities and assets have to be capable of being operated as a business, from the viewpoint of a market participant as defined in ASC 820, Fair Value Measurements. Two essential elements required for an integrated set of activities are inputs and outputs. The Company evaluated the Asset Purchase Agreement and in accordance with the guidance, determined it did not meet the definition of a business acquisition as the acquisition consisted solely of the two primary compounds, Brilacidin and related compounds, and Delparantag and related compounds, and certain other tangible assets. The Company did not acquire the right to any employees previously involved with the technology, or research processes previously in place at Seller. The Company has therefore accounted for the transaction as an asset acquisition.

The purchase price was allocated to the identified tangible and intangible assets acquired based on their relative fair values, which were derived from their individual estimated fair values of $96,000 and $4,706,000, respectively.

The following table summarizes the purchase price allocation for the assets acquired:

Intangible assets – patents rights – Brilacidin, Delparantag and other related compounds
  $ 4,706,000  
Tangible assets - Laboratory equipment and computer systems
  $ 96,000  

These tangible assets of $96,000 acquired were expensed to research and development costs in September 2013.
 
5. Patents, net
 
Patents, net consisted of the following (rounded to nearest thousand):
 
   
Useful life
   
March 31,
2014
   
June 30,
2013
 
                   
Purchased Patent Rights– Brilacidin, and related compounds (note 4)
  14     $ 4,082,000     $ -  
Purchased Patent Rights–Delparantag and related compounds (note 4)
  12       480,000       -  
Purchased Patent Rights– Anti-microbial- surfactants and related compounds (note 4)
  12       144,000       -  
Patents – Kevetrin and related compounds
  17       48,000       11,000  
                       
          $ 4,754,000     $ 11,000  
Accumulated amortization
          197,000       1,000  
          $ 4,557,000     $ 10,000  

 
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The patents are amortized on a straight-line basis over the estimated remaining useful lives of the assets, determined 12-17 years from the date of acquisition.

Amortization expense for the three and nine months ended March 31, 2014 and 2013 and from inception to March 31, 2014 was approximately $94,000, $0, $196,000, $0, and $197,000, respectively.

At March 31, 2014, the amortization period for all patents was approximately 11.25 to 16.25 years. Future estimated annual amortization expenses are approximately $346,000 for years from 2015 to 2025, $304,000 for the year 2026, $294,000 for the year 2027, $57,000 for the year 2028 and $3,000 for Year 2029 and 2030.
 
6. Property, plant and equipment, net
 
Property, plant and equipment, net consisted of the following (rounded to nearest thousand):

   
March 31,
2014
   
June 30,
2013
 
             
Testing equipment
  $ 43,000     $ -  
Accumulated depreciation
    2,000       -  
    $ 41,000     $ -  

Depreciation expense for the three and nine months ended March 31, 2014 and 2013 and from inception to March 31, 2014 was approximately $2,000, $0, $2,000, $0, and $2,000, respectively.

7. Accrued Expenses
 
Accrued expenses consisted of the following (rounded to nearest thousand):

   
March 31,
2014
   
June 30,
2013
 
             
Accrued research and development consulting fees
  $ 659,000     $ 200,000  
Accrued rent – related parties
    56,000       60,000  
Accrued interest – related parties
    201,000       294,000  
                 
Total
  $ 916,000     $ 554,000  
 
8.  Accrued Salaries and Payroll Taxes
 
Accrued salaries and payroll taxes consisted of the following (rounded to nearest thousand):

   
March 31,
2014
   
June 30,
2013
 
             
Accrued salaries – related parties
  $ 3,033,000     $ 3,244,000  
Accrued payroll taxes – related parties
    149,000       152,000  
Withholding tax – related parties
    40,000       31,000  
Withholding tax – employees
    13,000       4,000  
Total
  $ 3,235,000     $ 3,431,000  
 
On December 29, 2010, the Company entered into employment agreements with its two executive officers, Leo Ehrlich, the Company’s Chief Executive Officer, and Krishna Menon, Chief Scientific Officer. Both agreements provide for a three year term with each executive receiving an annual base salary for $350,000 per year commencing January 1, 2011, with an annual increase of 10% for each year commencing January 2012. The Board, at its discretion, may increase the base salary based upon relevant circumstances. On January 1, 2014 the Board a pproved the extension of the employment agreements for a one year period with a 10% increase in salary from the calendar year 2013 annual salary of $423,500, to an annual salary of $465,850.

 
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9. Commitments and Contingencies

Legal
 
Formatech is a former vendor of ours which had had received 184,375 shares of Cellceutix Class A Common Stock (“Cellceutix Stock”) for services that were not completed. Formatech had gone bankrupt while still in possession of the Cellceutix Stock. In July 2012, the US Bankruptcy Court allowed the trustee of the Formatech estate to sell the Cellceutix Stock. We have been advised that the stock has been sold in 2013 and the funds released to the secured creditors of Formatech. Cellceutix presently is in the unsecured creditors class and does not expect to receive any proceeds. 

Lease Commitments

Operating Leases
 
In September, 2013, Cellceutix Corporation signed a lease extension agreement with Cummings Properties for the company’s offices and laboratories at 100 Cummings Center, Suite 151-B Beverly, MA 01915. The lease is for a term of five years from October 1, 2013 to September 30, 2018 and requires monthly payments of approximately $17,000.

Future minimum lease payments required under the non-cancelable operating lease are as follows (rounded to nearest thousand):

Year ending June 30, Remainder of 2014
  $ 52,000  
2015
    207,000  
2016
    207,000  
2017
    207,000  
2018
    207,000  
2019
    54,000  
Total minimum payments
  $ 934,000  

Rent expense under this operating lease agreement was $56,000 and $0 for the three months ended March 31, 2014 and 2013, respectively, and $119,000 and $0 for the nine months ended March 31, 2014 and 2013, respectively. Before September, 2013, the Company paid rent to KARD for share of office space and details were shown at Note 10 Related Party Transactions.

Contractual Commitments

Clinical Trial Agreements between the Company and Contract Research Organizations- ABSSSI Trial

In December 2013, the Company entered into Clinical Trial Agreements with a Contract Research Organization (“CRO”). Terms include the Company making an upfront study advance of approximately $460,000 to the CRO and seven additional similar monthly payments to the CRO while the study is actively recruiting and treating patients. The advance will be earned as subjects are randomized into the Study. The Company has other terms with the CRO which allow for a bonus payment of $125,000 if the CRO meets study milestones; a non-refundable administrative start-up cost of $12,500 per Study Site; payment to CRO for pass-through costs within thirty days of receipt of invoice and third-party documentation from CRO; and pass-through costs are subject to a 15% invoicing fee.

During the three months and nine months ended March 31, 2013, the Company expensed approximately $630,000 and $684,000, respectively, and recorded under research and development costs in the condensed consolidated statements of operations related to this CRO.

 
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Clinical Trial Agreements between the Company and Contract Research Organizations- Phase 1 Trial

In December 2013, the Company entered into a Clinical Trial Agreement with a Contract Research Organization (“CRO”) to conduct a Phase 1 Pharmacokinetic and Bioequivalence study for the Company. The Company has agreed to pay the CRO approximately $185,000 for this study. As of March 31, 2014, the Company paid approximately $96,000, which was recorded under Prepaid expenses in the accompanying condensed consolidated balance sheets.

10. Related Party Transactions
 
Office Lease
 
Dr. Menon, the Company’s principal shareholder, President, and Director, also serves as the Chief Operating Officer and Director of Kard Scientific (“KARD”). On December 7, 2007, the Company began renting office space from KARD, on a month to month basis for $900 per month. This continued through August 2013 and since September 1, 2013, the Company no longer leases space from Kard. For the three and nine months ended March 31, 2014 and 2013 and the period June 20, 2007 (date of inception) through March 31, 2014, the Company has included approximately $0, $2,700, $1,800, $8,100 and $62,100 of rent expense paid to KARD in general and administrative expenses, respectively. At March 31, 2014 and June 30, 2013, rent payables to KARD of approximately $56,000 and $60,000, respectively, were included in accrued expenses.

In September 2013, Cellceutix Corporation signed a lease extension agreement with Cummings Properties for the company’s offices and laboratories at 100 Cummings Center, Suite 151-B Beverly, MA 01915. The lease is for a term of five years from October 1, 2013 to September 30, 2018 and requires monthly payments of approximately $16,000. Cellceutix had taken over the space occupied by KARD. In addition, Innovative Medical Research Inc., (“Innovative Medical”) a company owned by Leo Ehrlich and Dr. Krishna Menon, officers of Cellecutix has co-signed the lease and will rent approximately 200 square feet of office space, the space previously used by Cellceutix and will pay Cellceutix $900 per month, the same amount Cellceutix previously paid KARD. Innovative Medical paid total rent of $6,300 to Cellceutix from October 1, 2013 to March 31, 2014 and the rental payment was offset with the accrued rent owed to KARD.

Clinical Studies
 
As of September 28, 2007 the Company engaged KARD to conduct specified pre-clinical studies. The Company did not have an exclusive arrangement with KARD. All work performed by KARD needed prior approval by the executive officers of the Company, and the Company retained all intellectual property resulting from the services by KARD. The Company has now developed its own research study capabilities and no longer uses KARD. At March 31, 2014 and June 30, 2013, the accrued research and development expenses to KARD of approximately $1,686,000 were included in accounts payable.

11. Note Payable – Related Party
 
During the year ended June 30, 2010, Mr. Ehrlich loaned the Company a total of approximately $973,000. A condition for this note was that the Ehrlich Promissory Note A and Ehrlich Promissory Note B be replaced with a new note , Ehrlich Promissory Note C.  The Ehrlich Promissory Note C is an unsecured demand note that bears 9% simple interest per annum and is convertible into the Company’s common stock at $0.50 per share. The note requires that the interest rate on the amounts due on Ehrlich Promissory Notes A and B be changed retroactively, beginning October 1, 2009, to 9%. On April 1, 2011, the Company amended the Ehrlich Promissory Note C  and agreed to retroactively convert accrued interest of approximately $97,000 through December 31, 2010 into additional principal. During the year ended June 30, 2011, Mr. Ehrlich loaned the Company an additional approximately $997,000 which brought the total balance of the demand note to approximately $2,002,000. During the year ended June 30, 2012, Mr. Ehrlich loaned the Company an additional $20,000 which brought the balance of the demand note to approximately $2,022,000.

On May 8, 2012, the Company did not have the ability to repay the Ehrlich Promissory Note C loan and agreed to change the interest rate on the outstanding balance of principle and interest of approximately $2,248,000, as of March 31, 2012, from 9% simple interest to 10% simple interest, and the Company issued 2,000,000 Equity Incentive Options exercisable at $0.51 per share equal to 110% of the closing bid price of $0.46 per share on May 7, 2012. Options are valid for ten (10) years from the date of issuance.

At March 31, 2014 and June 30, 2013, approximately $201,000 and $294,000 was accrued as interest expense on this note. As of March 31, 2014, the balance of the demand note was approximately $2,022,000.

 
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12. Stock Options and Warrants

Stock Options
 
On April 1, 2014 the Board of Directors approved a stock option grant, for services rendered from January 7, 2014 to July 6, 2014, to a consultant to purchase 40,000 shares of common stock exercisable at $1.64 per share. The option was vested on April 1, 2014 and the option life is 5 years and will expire on March 31, 2019. In addition, the Company will pay the consultant $20,000 per month during the six month period from January 7, 2014 to July 6, 2014. The total value of this 40,000 shares of stock option was $55,396 and we accrued $27,698 as consulting expenses at March 31, 2014.

Assumptions used in the Black Scholes option-pricing model for the nine months ended March 31, 2014 and 2013 were as follows:
 
 
 
For the nine
months ended
   
For the nine
months ended
 
 
 
3/31/2014
   
3/31/2013
 
 
 
 
       
Average risk-free interest rate
    0.9%-1.98 %     1.53%-1.98 %
Average expected life- years
    3-5       5-10  
Expected volatility
    91.25% - 124.94 %     132.51%-137.33 %
Expected dividends
    0       0  

On April 5, 2009 the Board of Directors of the Registrant adopted the 2009 Stock Option Plan (“the Plan”). The Plan permits the grant of 2,000,000 shares of both Incentive Stock Options (“ISOs”), intended to qualify under section 422 of the Code, and Non-Qualified Stock Options.

Under the 2010 Equity Incentive Plan the total number of shares of Common Stock reserved and available for issuance under the Plan shall be 45,000,000 shares. Shares of Common Stock under the Plan (“Shares”) may consist, in whole or in part, of authorized and unissued shares or treasury shares. The term of each Stock Option shall be fixed by the Committee; provided, however, that an Incentive Stock Option may be granted only within the ten-year period commencing from the Effective Date and may only be exercised within ten years of the date of grant (or five years in the case of an Incentive Stock Option granted to an optionee who, at the time of grant, owns Common Stock possessing more than 10% of the total combined voting power of all classes of voting stock of the Company (“10% Shareholder”).
 
The following table summarizes all stock option activity under the plans:

   
Number of
Options
   
Weighted Average
Exercise Price
   
Weighted Average
Remaining Contractual Life (Years)
   
Aggregate Intrinsic Value
 
Outstanding at June 30, 2013
    39,142,500     $ 0.14     $ 7.47     $ 64,170,000  
Exercised
    (25,000 )     0.20       -          
Forfeited/expired
    -       -       -          
Outstanding at March 31, 2014
    39,117,500     $ 0.14     $ 6.73     $ 58,657,500  
Exercisable at March 31, 2014
    39,117,500     $ 0.14     $ 6.73     $ 58,657,500  

 
21
 
 
The exercise of 25,000 Common Stock options at $0.20 per share at $5,000 was disclosed at Note 13 Equity Transactions.

The Company recognized approximately $237,000, $44,000, $493,000 and $258,000 of stock-based compensation costs related to stock and stock options awards for the three and nine months ended March 31, 2014 and 2013, respectively; and approximately $7,673,000 for the period from inception to March 31, 2014.

Stock Warrants

From July 19, 2013 to September 17, 2013, the Company issued 1,025,000 Class A common shares par value $.0001 to a warrant holder upon exercise of Common Stock Purchase Warrants exercisable at $1 per share. The Company received an aggregate of $1,025,000. The issuance was exempt from registration under Section 4(2) of the Securities Act. In addition, on January 3, 2014, the Company issued 200,000 Class A common shares par value $.0001 to same warrant holder upon exercise of Common Stock Purchase Warrants exercisable at $1 per share and received an aggregate of $200,000 (See Note 13 Equity Transactions).

On December 31, 2013, the Company issued 848,084 Class A common shares par value $.0001 to two warrant holders upon exercise of Common Stock Purchase Warrants exercisable at the range from $0.39 to $0.53 per share, with total of $400,000. The Company received $400,000 as a Subscription Receivable on April 1, 2014. The issuance was exempt from registration under Section 4(2) of the Securities Act.

Extension of the expiration date of an aggregate of 2,223,000 Series B, Series C, and Series D common share purchase warrants

On December 1, 2013, 2,223,000 Series B, Series C, and Series D common share purchase warrants issued by the Company were modified to extend their maturity date to December 31, 2015. As the Company is in an accumulated deficit position, the deemed dividend was charged against additional paid-in-capital for common shares, there being no retained earnings from which to declare a dividend. The net income (loss) attributable to common shareholders reflects both the net income (loss) and the deemed dividend.

The deemed dividend of $1,880,000 was computed as the incremental value of the modified warrants over the unmodified warrants on the modification date using a per share price of the range from $0.50 to $1.50 per share which were the contemporaneous private placement offering price. Assumptions used in the Black Scholes option-pricing model for these warrants were as follows:
 
Average risk-free interest rate
    0.29 %
Average expected life- years
    2  
Expected volatility
    55.22 %
Expected dividends
    0  

On January 23, 2014, the Company issued 25,000 shares of restricted common stock and 25,000 common share purchase warrants exercisable at $1.79 a share to one consultant. The shares will be vested on March 31, 2014, valued at approximately $44,750 and the option life is three years.

The following table summarizes stock warrants as of March 31, 2014 and June 30, 2013:

   
Warrants
   
Weighted
Average
Exercise Price
   
Weighted Average
Remaining Contractual Life (Years)
   
Aggregate
Intrinsic
Value
 
Outstanding at June 30, 2013
    5,571,084     $ 0.92       1.43     $ 4,793,786  
Extended
    2,223,000       1.00       1.75       -  
Granted
    25,000       1.79       2.82          
Exercised
    (2,073,084 )   $ 1.00       -       -  
Forfeited/expired
    (2,223,000 )     -       -       -  
Outstanding at March 31, 2014
    3,523,000     $ 1.01       1.36     $ 2,238,720  
Exercisable at March 31, 2014
    3,523,000     $ 1.01       1.36     $ 2,238,720  
 
 
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13. Equity Transactions

Polymedix Trustee

On September 4, 2013, the Company purchased substantially all of the assets of Polymedix Inc, and Polymedix Pharmaceuticals, Inc. from the U.S. Bankruptcy Court. The purchase price included the issuance of 1,400,000 shares of the Company’s Class A common stock.
 
$20 million Class A Common Stock Purchase Agreement with Aspire Capital Fund, LLC

On October 25, 2013, we terminated a previous agreement with Aspire Capital Fund, LLC, an Illinois limited liability company (Aspire Capital), and entered into a new Class A Common Stock Purchase Agreement (the “Purchase Agreement”) with Aspire Capital, which provides that upon meeting the terms of the agreement, Aspire Capital is committed to purchase up to an aggregate of $20,000,000 of our shares of Class A Common Stock over the approximately 36-month term of the Purchase Agreement. In consideration for entering into the Purchase Agreement, the Company issued to Aspire Capital 210,523 shares of our Class A Common Stock as a commitment fee. The commitment fee of $373,000 will be amortized as the funding is received. The amortized amount of $30,000 was debited to additional paid-in capital. The unamortized portion is carried on the balance sheet as deferred offering costs and was $343,000 at March 31, 2014.

Concurrently with entering into the Purchase Agreement, the Company agreed to file one or more registration statements as permissible and necessary under the Securities Act of 1933, as amended, or the Securities Act, for the sale of shares of our Class A Common Stock that have been and may be issued to Aspire Capital under the Purchase Agreement. On November 4, 2013, the Company filed a Form S-3 registration statement and the registration statement was declared effective by the SEC on November 15, 2013.
 
Under the Purchase Agreement, on any trading day selected by Cellceutix which the closing sale price of our Class A Common Stock exceeds $0.25 per share, we may direct Aspire Capital to purchase up to 200,000 shares of our Class A Common Stock per trading day. The Purchase Price of such shares is equal to the lesser of a) the lowest sale price of our Class A Common Stock on the purchase date; or b) the arithmetic average of the three lowest closing sale prices for our Class A Common Stock during the twelve consecutive trading days ending on the trading day immediately preceding the purchase date.
 
In addition, on any date on which we submit a Purchase Notice to Aspire Capital for purchase of at least 100,000 Purchase Shares and the closing sale price of our stock is equal to or greater than $0.50 per share, we also have the right to direct Aspire Capital to purchase an amount of stock equal to up to 30% of the aggregate shares of the our Class A Common Stock traded on the OTC Bulletin Board on the next trading day, subject to the VWAP Purchase Share Volume Maximum and the VWAP Minimum Price Threshold, which is equal to the greater of (a) 90% of the closing price of our Class A Common Stock on the business day immediately preceding the VWAP Purchase Date or (b) such higher price as set forth by the Company in the VWAP Purchase Notice. The VWAP Purchase Price of such shares is the lower of (a) the Closing Sale Price on the VWAP Purchase Date; or 95% of the volume-weighted average price for our Class A Common Stock traded on the OTC Bulletin Board; and (b)on the VWAP Purchase Date, if the aggregate shares to be purchased on that date have not exceeded the VWAP Purchase Share Volume Maximum or during that portion of the VWAP Purchase Date until such time as the sooner to occur of (i) the time at which the aggregate shares traded on the OTC Bulletin Board exceed the VWAP Purchase Share Volume Maximum or (ii) the time at which the sale price of our Class A Common Stock falls below the VWAP Minimum Price Threshold.

The purchase price will be adjusted for any reorganization, recapitalization, non-cash dividend, stock split, or other similar transaction occurring during the trading day(s) used to compute the purchase price. We may deliver multiple Purchase Notices and VWAP Purchase Notices to Aspire Capital from time to time during the term of the Purchase Agreement, so long as the most recent purchase has been completed.
 
Under the Purchase Agreement, we and Aspire Capital may not affect any sales of shares of our Class A Common Stock under the Purchase Agreement on any trading day that the closing sale price of our Class A Common Stock is less than $0.25 per share.

The Company is never under any obligation to sell shares to Aspire Capital Fund. Aspire Capital Fund has no rights to require the Company to sell shares.

 
23
 
 
For the period from October 25, 2013 to March 31, 2014, the Company had completed sales to Aspire totaling 900,000 shares of common stock generating gross proceeds of approximately $1.6 million. As of March 31, 2014, a balance of $18.4 million remains and is available under the financing arrangement.

From April 1, 2014 to May 8, 2014, the Company has generated additional proceeds of approximately $1,402,000 under the Common Stock Purchase Agreement with Aspire on the sale 900,000 shares of its common stock.

$10 million Class A Common Stock Purchase Agreement with Aspire Capital Fund, LLC- Prior Agreement

During the fiscal year ended June 30, 2013, the Company, under its prior purchase agreement with Aspire, had completed sales to Aspire totaling 2,712,208 shares of common stock generating gross proceeds of approximately $4,383,000. During the period from July 1, 2013 to October 24, 2013, the Company had completed sales, under its prior purchase agreement with Aspire totaling 3,204,537 shares of common stock generating gross proceeds of approximately $5,618,000. As of October 24, 2013, Aspire Capital completed its commitment to purchase up to an aggregate of $10,000,000 of our shares of Class A Common Stock under the prior Common Stock Purchase Agreement dated December 6, 2012.

Issuance of Common Stock by Exercise of Common Stock Purchase Warrants

From July 19, 2013 to September 17, 2013, the Company issued 1,025,000 Class A common shares par value $.0001 to a warrant holder upon exercise of Common Stock Purchase Warrants exercisable at $1 per share. The Company received an aggregate of $1,025,000 from the exercise of these warrants. The issuance was exempt from registration under Section 4(2) of the Securities Act. In addition, on January 3, 2014, the Board of Directors of the Company authorized the exercise of 200,000 Warrants into 200,000 shares of Common Stock by Huang Min Chung, followed by the resolution of the extension of the expiration date of an aggregate of 2,223,000 Series B, Series C, and Series D common share purchase warrants of the Company to December 31, 2015 made by the Board of Directors on December 1, 2013. It was resolved that the Board of Directors approved the issuance 200,000 fully paid Common shares par value $0.0001 per share, of the capital stock of Cellceutix Corporation to Huang Min Chung which shares have been registered in the S-3 registration statement rendered effective February 14, 2013 by the SEC. The total exercise price was $200,000.

On December 31, 2013, the Company issued 848,084 Class A common shares par value $.0001 to two warrant holders upon exercise of Common Stock Purchase Warrants exercisable at the range from $0.39 to $0.53 per share, with a total exercise price of $400,000. The issuance was exempt from registration under Section 4(2) of the Securities Act.

Issuance of Common Stock by Exercise of Common Stock Options

On March 18, 2014, the Company issued 25,000 Class A common shares par value $.0001 upon exercise of 25,000 Common Stock options at $0.20 per share, for total proceeds of $5,000.

Issuance of Common Stock to Consultants and Employees

On December 17, 2013, the Company issued 5,000 shares of restricted Class A common shares par value $.0001 to one consultant valued at approximately $9,000 for prior services.

On December 31, 2013, the Company issued 50,000 shares of restricted Class A common shares par value $.0001 to two consultants valued at approximately $105,000 for prior services.

On December 31, 2013, the Company issued 60,000 shares of restricted Class A common shares par value $.0001 to six employees as a year-end bonus valued at approximately $96,000.

On October 17, 2013, the Board of Directors approved the stock grant of 35,000 shares of restricted Class A common stock to be issued and vested on January 6, 2014 to a consultant valued at $70,000.

 
24
 
 
On January 23, 2014, the Company issued 25,000 shares of restricted Class A common stock and 25,000 stock options exercisable at $1.79 per share to a consultant. The shares were granted on January 23, 2014 and vested on March 31, 2014 were valued at $44,750. The option life is three years and valued at $28,988

On January 23, 2014, the Company further issued 25,000 shares of restricted Class A common shares par value $.0001 at $1.79 per share to a consultant. The shares were granted on January 23, 2014, vested on March 31, 2014, and were valued at $44,750.

On March 31, 2014, the Company issued 25,000 shares of restricted Class A common shares, par value $.0001, to a consultant for prior services rendered. The shares were granted and vested on March 31, 2014. The shares were valued at $41,000.

On April 1, 2014 the Board of Directors approved a stock option grant, for services rendered from January 7, 2014 to July 6, 2014, to a consultant to purchase 40,000 shares of common stock exercisable at $1.64 per share. The option was vested on April 1, 2014,the option life is 5 years and will expire on March 31, 2019. In addition, the Company will pay the consultant $20,000 per month during the six month period from January 7, 2014 to July 6, 2014. The total value of this 40,000 shares of stock option was $55,396 and assumptions we used in the Black Scholes option-pricing model were disclosed in Note 12. We accrued $27,698 as consulting fee expense at March 31, 2014 and will be reallocated to additional paid-in capital on April 1, 2014.

In restricted stock and stock option issuances where the employee or consultant service inception date precedes the grant date, at each reporting date before the grant date, the fair value of the award is re-measured with compensation cost recorded accordingly. Then, in the period in which the grant date occurs, cumulative compensation cost is adjusted to reflect the cumulative effect of measuring compensation cost based on the fair value at the grant date rather than the fair value(s) previously reported.

14. Subsequent Events
 
From April 1, 2014 to May 8, 2014, the Company has generated additional proceeds of approximately $1,402,000 under the Common Stock Purchase Agreement with Aspire from the sale 900,000 shares of its common stock.

On April 1, 2014, the Board of Directors approved the stock option grant to a consultant to purchase 40,000 shares of common stock exercisable at $1.64 per share and we accrued $27,698 as consulting fee expense at March 31, 2014 (See Note 13 Equity Transactions).

On April 30, 2014, the Company received an exercise notice from a warrant holder for exercise of 200,000 warrants and the Company received the $200,000 on May 2, 2014.

 
25
 
 
ITEM 2. MANAGEMENT'S DISCUSSION AND FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and plan of operations should be read in conjunction with the financial statements and the notes to those statements included in this Form 10-K. This discussion includes forward-looking statements that involve risk and uncertainties. As a result of many factors, such as those set forth under “Risk Factors,” actual results may differ materially from those anticipated in these forward-looking statements.
 
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements. In order to comply with the terms of the safe harbor, the Company notes that in addition to the description of historical facts contained herein, this report contains certain forward-looking statements that involve risks and uncertainties as detailed herein and from time to time in the Company’s other filings with the Securities and Exchange Commission and elsewhere. Such statements are based on management’s current expectations and are subject to a number of factors and uncertainties, which could cause actual results to differ materially from those, described in the forward-looking statements. These factors include, among others: (a) the Company’s fluctuations in sales and operating results; (b) risks associated with international operations; (c) regulatory, competitive and contractual risks; (d) product development risks; (e) the ability to achieve strategic initiatives, including but not limited to the ability to achieve sales growth across the business segments through a combination of enhanced sales force, new products, and customer service; and (f) pending litigation.
 
Management’s Plan of Operation
 
Research and Development Activities
 
We acquire exclusive rights to pharmaceutical compound candidates that are designed for treatment of diseases which may be either existing or diseases identified in the future. The Company spends most of its efforts and resources on its anti-cancer compound Kevetrin, for the treatment of certain cancers, Prurisol, for the treatment of psoriasis, and Brilacidin for the treatments of skin infections and oral mucositis. Based on the studies to date, the Company has decided to advance these drugs along the regulatory and clinical pathway. We anticipate using our expertise to manage and perform what we believe are the most critical aspects of the product development process which include: (i) the design and oversight of clinical trials; (ii) the development and execution of strategies for the protection and maintenance of intellectual property rights; and (iii) the interaction with regulatory authorities internationally. We expect to concentrate on product development and engage in a limited way in product discovery, avoiding the significant investment of time and financial resources that is generally required before a compound is identified and brought into clinical trials. At this time the Company is focusing its research and development efforts on Kevetrin, Prurisol, Brilacidin, and to a lesser amount on our other anti-infectives and anti-fungal compounds.
 
We are a clinical stage company. We have no product sales to date and we will not receive any product revenue until we receive approval from the FDA or equivalent foreign regulatory bodies to begin selling our pharmaceutical candidates. Developing pharmaceutical products, however, is a lengthy and very expensive process. Assuming we do not encounter any unforeseen safety issues during the course of developing our product candidates, we do not expect to complete the development of a product candidate for several years, if ever.
 
Polymedix Asset Acquisition

On September 4, 2013, the Company purchased substantially all of the assets of Polymedix Inc, and Polymedix Pharmaceuticals, Inc. from the U.S. Bankruptcy Court. PolyMedix Inc. was founded in 2002 based on technology licensed from the University of Pennsylvania (Penn). The purchased bankruptcy estate included two license agreements from Penn, an exclusive patent license agreement and a nonexclusive software license agreement, that were acquired by Cellceutix. Summaries of each agreement are below.
 
Patent License Agreement
 
 
·  
Effective date is January 3, 2003
 
·  
License and world-wide right to use and practice under the Penn Patent Rights to make, use and sell Penn Licensed Products
 
 
26
 
 
 
·  
Exclusive license for Penn Patent Rights that include all US and foreign patents issued or issuing from a family of intellectual property that covers composition of matter of polymers, oligomers and small molecules and their uses as antimicrobial or anti-heparin agents.
 
·  
Nonexclusive license for Penn Patent Rights that include all US and foreign patents issued or issuing from a family of intellectual property that covers Penn Software useful for the design and study of Penn Licensed Products.
 
o  
Penn agrees not to license any such Penn Patent Rights to any other party
 
·  
All patent extensions including continuations, divisionals, renewals, reissues, substitutions or additions are included
 
·  
Penn Licensed Products are products that infringe at least one valid claim of the Penn Patent Rights
 
·  
Qualified right to sublicense in the US and throughout the world
 
·  
Penn retains right to use and practice under the Penn Patent Rights for educational and non-commercial research purposes
 
·  
License is subject to all applicable US government rights pursuant to Public Laws 96-517, 97-256 and 98-620, codified as 35 U.S.C. 200-212.
 
·  
In partial consideration of the license, Licensee shall pay to Penn a royalty of 1) 3.0% on gross sales of a pharmaceutical product, 2) 1.5% of gross-sales of a medical devise or other products approved by a 510(k) regulatory filing or 3) 0.5% on all other gross sales for Penn Licensed Products sold by Licensee, its Affiliates and/or its Sublicensees.
 
·  
Term of the agreement is until the expiration of the last to expire of any issued Penn Patent Rights
 
Software License Agreement
 
 
·  
Effective date is May 30, 2003
 
·  
Nonexclusive License to use, copy, distribute, modify and prepare derivative works based on Penn Software
 
o  
Penn agrees not to grant any additional licenses to the Penn Software
 
·  
Penn Software is useful in the design and study of antimicrobial, anti-heparin and other products
 
·  
Qualified right to sublicense in the US and throughout the world
 
·  
Penn retains right to use and practice Penn Software for educational and non-commercial research purposes
 
·  
License is subject to all applicable US government rights pursuant to Public Laws 96-517, 97-256 and 98-620, codified as 35 U.S.C. 200-212.
 
·  
In consideration of the license, a one-time payment was made. There are no royalty or other monetary obligations
 
·  
Term of the agreement is until termination of the Patent License Agreement
 
 
27
 
 
The aggregate purchase price for the sale and transfer of the Purchased Assets was $2.1 million in cash, plus 1.4 million shares of the Company’s Class A common stock, total aggregate purchase price of approximately $4.8 million. At any time between one day after the Closing and 365 days after the Closing, the holder of these 1.4 million shares may make written demand upon the Company for the Company to repurchase the shares for $1 per share. See Part 1, Item 1 of our Annual Report on Form 10-K for the year ended June 30, 2013 for more information regarding this asset acquisition.

Intellectual Property, Patents and Licenses Acquired

See below list of material intellectual property, patents, licenses acquired and their expiration dates.
 
Brilacidin

The intravenous formulation of Polymedix’s lead product candidate, brilacidin, is an antibiotic which has the potential to treat a variety of indications, including ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS (“ABSSSI”) caused by either drug-sensitive or drug-resistant strains of Staphylococcus aureus bacteria.
 
Acute Bacterial Skin And Skin Structure Infections (“ABSSSI”)
 
In April 2012, Polymedix completed and announced positive results from a Phase 2 clinical trial with brilacidin. This randomized, blinded, active-controlled, multinational Phase 2 clinical trial was conducted at multiple sites in Canada, Russia and Ukraine. The study objectives were to evaluate the safety and efficacy of brilacidin as treatment for ABSSSI caused by Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus (MRSA). The study objectives were met, with all evaluated doses of brilacidin demonstrating similar clinical response rates to those of the active control, daptomycin. The study was conducted in accordance with FDA’s most recent ABSSSI guidelines and is intended to support regulatory approval in the United States.

In late 2012, prior to the dissolution of PolyMedix, an extensive PK-PD analysis of all brilacidin efficacy and safety data was conducted and discussed at a meeting with the FDA. It was determined that commonly observed adverse events, including hypertension and numbness/tingling, were related to total administered dose, and that adverse events could be significantly reduced by simply lowering the total dose. Given that brilacidin kills bacteria in a concentration-dependent manner, there is a unique opportunity to reduce adverse events and maintain high clinical efficacy by contracting the dosing regimen to 1-3 days, thereby gaining the additional benefits of higher patient compliance and reduced health care costs. The FDA therefore supported the use of brilacidin in a U.S.-based phase 2b clinical trial comparing three short-course regimens (two single-dose regimens and one 3-day regimen) to an active comparator, daptomycin. Similar to the previous trial, the current study is to enroll approximately 200 patients (50 patients per arm).

This phase 2b trial received IRB-approval in early January 2014 and enrolled its first patient in February 2014. At this time patient enrollment is expected to be completed in August/September 2014.

Brilacidin for Eye and Ear Indications

Cellceutix is formulating and conducting preclinical experiments using outside vendors on brilacidin for ophthalmic infections, including keratitis and conjunctivitis, and for ear-related infections, such as otitis media. Upon a successful formulation the Company plans to advance these drugs into the clinic. The Company believes that this work is challenging and will not be completed in 2014.

Oral Mucositis
 
In animal models of oral mucositis, an oral rinse containing brilacidin was shown to reduce the occurrence of severe ulcerative oral mucositis by more than 90% compared to placebo. Brilacidin and related compounds have shown antibacterial, anti-biofilm and anti-inflammatory properties in various pre-clinical studies. Polymedix believed that the combination of these attributes contribute to the efficacy of brilacidin in these animal models. In December 2014, the Company filed an application with the U.S. Food and Drug Administration requesting Orphan Drug designation for brilacidin as a drug candidate for the prevention oral mucositis in head and neck cancer. FDA has now advised the company that the data would indicate the brilacidin-OM could treat not only patients that have radiation induced OM but as well as patients with chemotherapy-induced OM. Therefore the target population would exceed the number of patients that would qualified for orphan drug designation. The company still believes that brilacidin-OM meets the potential to capture significant market share with the introduction of a new therapy for OM. The Company is now completing the preclinical development necessary for filing an Investigational New Drug (IND) application with the FDA.

 
28
 
 
Delparantag
 
Delparantag (formerly PMX-60056) is a synthetic, small-molecule intended to reverse the effects of the commonly used anticoagulants unfractionated heparin (UFH), and its derivatives, low molecular weight heparins (LMWH), to help manage the balance of antithrombosis and anticoagulation and reduce the incidence of bleeding in certain interventional cardiology procedures, such as Percutaneous Coronary Intervention (PCI) and Coronary Arterial Bypass Grafting (CABG), and other situations where UFH and LMWH are used and bleeding may occur.
 
In May 2012, Polymedix announced that they had stopped enrollment in two clinical trials for delparantag: a Phase 2 clinical trial for reversing the anticoagulant activity of UFH in patients undergoing PCI procedures, and a Phase 1B/2 clinical trial for reversing the anticoagulant activity of the LMWH enoxaparin in healthy volunteers. While delparantag showed activity in neutralizing both UFH and the LMWH enoxaparin in these clinical trials, Polymedix decided to stop enrollment in both trials due to observations of reductions in blood pressure in some patients. Presently we are looking into reformulating the compound, as a means by which blood pressure reactions could be reduced or eliminated. At the present time this project has a lower priority than our anti-biotic compounds due to limited resources of staff and funding and a s of the date of this filing the Company has engaged in limited work on this compound.

Candida

Extensive screening of the compounds acquired has identified five promising drug candidates for fungal infections, including PMX1502 and PMX1408 as stand-outs for anti-Candida fungal activity to be used for both oral and disseminated candidiasis. We are now actively engaged in further research on these compounds.

Other Candidates

Other product candidates acquired by us include, without limitation, compounds active against gram-negative bacteria, fungal infections, malaria, tuberculosis, bio warfare pathogens, and PolyCide® antimicrobial biomaterials.

We are currently evaluating all these programs. We believe it is still too soon in our acquisition process to develop a comprehensive plan or budget for the development costs of these newly acquired Polymedix Assets.

Our Other Compounds
 
Kevetrin
 
On June 21, 2012, the U.S. Food and Drug Administration ("FDA") approved the Investigational New Drug (IND) application for Kevetrin, Cellceutix's novel anti-cancer compound. The Phase 1 trial being conducted at Harvard Cancer Center's Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center was activated in October of 2012. The open-label, dose-escalation clinical trial is evaluating Kevetrin, administered intravenously in patients with a variety of different solid tumor cancer types in patients with advanced-stage cancers. Primary endpoints for the study will be to determine the pharmacokinetics / pharmacodynamics, safety, dose limiting toxicities (DLT), and maximum tolerated dose (MTD) and to establish the dose for future clinical trials.

In June of 2013, the Phase 1 trial with Dana-Farber Cancer Institute and partners Beth Israel Deaconess Medical Center and Massachusetts General Hospital was presented at the American Association for Clinical Oncology in Chicago. The poster summarized the status of the trial, at which time, 10 patients had been enrolled in 3 cohorts with no DLTs observed.

As of April 2014, we are in the 7 th cohort of patients. The dose escalation continues to progress as we have not yet observed any DLTs or the MTD. We anticipate this endpoint will be reached in the second half of 2014.
 
The trial is registered on www.clinicaltrials.gov : http://clinicaltrials.gov/ct2/show/NCT01664000?term=Kevetrin&rank=1
 
 
29
 
 
In 2012, we entered into an agreement with Beth Israel Deaconess Medical Center (BIDMC), a teaching hospital of Harvard Medical School, on an innovative research project with Kevetrin. The Medical Center wishes to exploit the nuclear and/or mitochondrial pro-apoptotic function of p53 in melanoma and renal cell carcinoma, two types of cancer that are particularly resistant to therapy. BIDMC initiated combination studies with multikinase inhibitors which activate pro-apoptotic activity by translocation of p53 in mitochondria thereby inducing apoptosis. Apoptosis is enhanced by MDM2 inhibitors by stabilizing p53. As presented at the American Association for Cancer Research (AACR) meeting in 2012, Kevetrin phosphorylates MDM2 which activates and stabilizes p53 by monoubiquitination inducing apoptosis. Prior data from the BIDMC laboratory showed that agents of this class can augment the pro-apoptotic and antitumor effects of MDM2 antagonists and is expected to have a synergistic effect with Kevetrin. BIDMC tested the effects of Kevetrin alone and in combination with FDA-approved VEGFR antagonists in the renal cell carcinoma and melanoma studies. In vitro study endpoints include apoptosis by measuring caspase activation and PARP cleavage. In vivo endpoints include efficacy in a xenograft model, tumor vascularity, p53 levels, p21 expression and apoptosis. This study provided vital insight to exploit the nuclear and/or mitochondrial pro-apoptotic function by Kevetrin in combination with other multikinase inhibitors in treatment of these difficult to treat malignancies. The results received from BIDMC in April 2013, showed apoptosis induction (TUNEL assay) in renal cancer (786-O).

Results of these preclinical tests provided to date to the Company are encouraging and BIDMC and Cellceutix wish to move the study further. Cellceutix has provided the requested information from BIDMC that will be used to investigate a Specialized Programs of Research Excellence (SPORE) grant for a Phase 2 clinical study of renal cancer upon completion of the successful Phase 1 clinical study presently in progress.

In 2012, we formed an agreement with The University of Bologna in Italy (the “University”) and The Italian Cooperative Study Group on Chronic Myeloid Leukemia (ICSG on CML) and Acute Leukemia (GIMEMA Group) to test Kevetrin against Acute Myelogenous Leukemia (AML). We have been advised that the study, a Phase 1b trial, will be titled “A Multi-Center, Open-Label, Phase 1b Study of Escalating Doses of Kevetrin (Thioureidobutyronitrile) Administered Intravenously, with Cytarabine Administered A) Subcutaneously, or B) Intravenously, in Patients with Acute Myelogenous Leukemia (AML).” The trial’s principal investigator will begin this Phase 1b trial once the MTD is achieved at the Dana Farber trial. The University of Bologna will source the funding for this trial. 

On May 20, 2009, the Company filed a U.S. patent application covering pharmaceutical formulations of Kevetrin and many novel compounds having similar structures to Kevetrin that may have potential as drug development candidates. The patent will expire May 19, 2029.
 
Prurisol

Prurisol is our anti-psoriasis drug candidate. It is a small molecule with a molecular weight of less than 500 MW. It is synthesized through a multi-step process using commercially available starting materials. Prurisol acts through immune modulation and PRINS reduction.

In June 2012, we participated in a pre IND meeting with the U.S. Food and Drug Administration ("FDA") pertaining to Prurisol our compound targeting psoriasis. Cellceutix had requested the meeting for guidance on its initiatives to seek a section 505(b)(2) designation for Prurisol, which would allow us to forgo early-stage trials and advance Prurisol into later-stage clinical trials. Cellceutix was advised by the FDA that a 505(b)(2) application would be an acceptable approach for Prurisol.

In January 2014, the Company received approval from the Institutional Review Board ("IRB") responsible for the planned clinical study of the Company's psoriasis drug Prurisol at Phase One Solutions, a Florida phase 1 unit. The Bioequivalence trial is a short crossover study being conducted at the request of the U.S. Food and Drug Administration ("FDA") with the purpose of demonstrating that Prurisol, an ester of abacavir, converts into abacavir in humans, just as it did in animal models.

After receiving IRB approval, Cellceutix filed an Investigational New Drug application with the FDA in February of 2014. Upon the advice of the FDA, In April 2014, we initiated a Bioequivalence study At Phase One Solutions in Florida, entitled: “A Randomized, Open-Label, Single-Dose, 2 Period Crossover Pharmacokinetic and Bioequivalence Study, with a Lead-In Dose Period, Evaluating Oral Abacavir Acetate (Prurisol ™ ) and Oral Abacavir Sulfate (Ziagen ® ) in Healthy Volunteers”. The Primary Objective is to determine the average bioequivalence of abacavir derived from Prurisol in comparison with abacavir derived from the commercially available tablet formulation of Ziagen (abacavir sulfate). The Secondary Objectives are to evaluate the safety and tolerability of Prurisol when administered in single doses to HLA-B*5701- negative healthy volunteers and to describe the pharmacokinetics of three escalating single doses of Prurisol with reference to doses of Ziagen and the maximum dose of Prurisol administered.

 
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The trial, activated in April of 2014, is expected to complete dosing in June 2014. Additional time will be necessary for laboratory analysis. Only upon a successful study completion, the Company will move forward with the initiation of a larger Phase 2 trial under the guidance from the FDA that a 505(b)(2) designation is an appropriate developmental pathway for Prurisol.

Prurisol was manufactured and formulated for Cellceutix by Dr. Reddy's Laboratories and was completed in August 2013.
 
The trial is registered on www.clinicaltrials.gov :
http://clinicaltrials.gov/ct2/show/NCT02101216?term=cellceutix&rank=1
 
Liquidity and Capital Resources
 
As of March 31, 2014 the Company had a cash balance of approximately $5.1 million.

Aspire Capital Agreement

On October 25, 2013, we terminated a previous agreement with Aspire Capital Fund, LLC, an Illinois limited liability company (Aspire Capital), and entered into a new stock purchase agreement (the “Purchase Agreement”) with Aspire Capital.

The new Purchase Agreement provides that upon meeting the terms of the agreement, Aspire Capital is committed to purchase up to an aggregate of $20,000,000 of our shares of Class A Common Stock over the approximately 36-month term of the Purchase Agreement. In consideration for entering into the Purchase Agreement, the Company issued to Aspire Capital 210,523 shares of our Class A Common Stock as a commitment fee. The commitment fee will be amortized as the funding is received. The unamortized portion is carried on the balance sheet as deferred offering costs. Concurrently with entering into the Purchase Agreement, the Company agreed to file one or more registration statements as permissible and necessary under the Securities Act of 1933, as amended, or the Securities Act, for the sale of shares of our Class A Common Stock that have been and may be issued to Aspire Capital under the Purchase Agreement. On November 4, 2013, the Company filed a Form S-3 registration statement and the registration statement was declared effective by the SEC on November 15, 2013.
 
Under the Purchase Agreement, on any trading day selected by Cellceutix which the closing sale price of our Class A Common Stock exceeds $0.25 per share, we may direct Aspire Capital to purchase up to 200,000 shares of our Class A Common Stock per trading day.

The Purchase Price of such shares is equal to the lesser of (a) the lowest sale price of our Class A Common Stock on the purchase date; or (b) the arithmetic average of the three lowest closing sale prices for our Class A Common Stock during the twelve consecutive trading days ending on the trading day immediately preceding the purchase date.
 
In addition, on any date on which we submit a Purchase Notice to Aspire Capital for purchase of at least 100,000 Purchase Shares and the closing sale price of our stock is equal to or greater than $0.50 per share, we also have the right to direct Aspire Capital to purchase an amount of stock equal to up to 30% of the aggregate shares of the our Class A Common Stock traded on the OTC Bulletin Board on the next trading day, subject to the VWAP Purchase Share Volume Maximum and the VWAP Minimum Price Threshold, which is equal to the greater of (a) 90% of the closing price of our Class A Common Stock on the business day immediately preceding the VWAP Purchase Date or (b) such higher price as set forth by the Company in the VWAP Purchase Notice. The VWAP Purchase Price of such shares is the lower of (a) the Closing Sale Price on the VWAP Purchase Date; or 95% of the volume-weighted average price for our Class A Common Stock traded on the OTC Bulletin Board; and (b)on the VWAP Purchase Date, if the aggregate shares to be purchased on that date have not exceeded the VWAP Purchase Share Volume Maximum or during that portion of the VWAP Purchase Date until such time as the sooner to occur of (i) the time at which the aggregate shares traded on the OTC Bulletin Board exceed the VWAP Purchase Share Volume Maximum or (ii) the time at which the sale price of our Class A Common Stock falls below the VWAP Minimum Price Threshold.

 
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The purchase price will be adjusted for any reorganization, recapitalization, non-cash dividend, stock split, or other similar transaction occurring during the trading day(s) used to compute the purchase price. We may deliver multiple Purchase Notices and VWAP Purchase Notices to Aspire Capital from time to time during the term of the Purchase Agreement, so long as the most recent purchase has been completed.
 
Under the Purchase Agreement, we and Aspire Capital may not affect any sales of shares of our Class A Common Stock under the Purchase Agreement on any trading day that the closing sale price of our Class A Common Stock is less than $0.25 per share.

The Company is never under any obligation to sell shares to Aspire Capital Fund. Aspire Capital Fund has no rights to require the Company to sell shares.
 
During the three months ended March 31, 2014, the Company had completed sales to Aspire totaling 900,000 shares of common stock generating gross proceeds of approximately $1.6 million. As of March 31, 2014, a balance of $18.4 million remains and is available under the financing arrangement. From April 1, 2014 to May 8, 2014, the Company has generated additional proceeds of approximately $1,402,000 under the Common Stock Purchase Agreement with Aspire on the sale 900,000 shares of its common stock.
 
The Company expects to incur losses from its operations for the next few years. We expect to incur increasing research and development expenses, including expenses related to additional clinical trials. We expect that our general and administrative expenses will increase in the future as we expand our business development, add employees, consultants, infrastructure and incur additional costs related to being a public company, including incremental audit fees for compliance with the provisions of the Sarbanes-Oxley Act, investor relations programs and increased professional services. Based upon our expected rate of expenditures, we currently do not have sufficient cash reserves to meet all of our anticipated obligations through our fiscal year end of June 30, 2015. 
 
Requirement for Additional Working Capital

Research and Development Costs. We intend to use the net proceeds from the above Aspire transaction to fund our product development programs and for general corporate purposes, and therefore anticipate having sufficient funds to meet our planned drug development for the next twelve (12) months. We plan to incur the following expenses of approximately $16,780,000 over the next twelve (12) months: 

1. Research and Development- $1,500,000 in preclinical development costs including testing Kevetrin on additional tumors, and advancement of our anti- infective and anti-fungal compounds towards clinical trials.
 
2. Clinical trials - $11,700,000. We have budgeted $1,200,000 for our Phase 1 Kevetrin trials; $3,000,000 for the Prurisol phase 1 crossover study and phase 2/3 trials; $4,500,000 for the Brilicidin ABSSSI Phase 2b trials and the start of Phase 3 trials; and $3,000,000 for the planned Brilicidin Oral Mucositis Phase 2 trials.
 
3. Corporate overhead of $3,500,000: Budgeted office salaries, legal, accounting and other costs expected to be incurred.
 
4. Capital costs of $80,000: Estimated cost for equipment and laboratory improvements.
 
The Company will be unable to proceed with its full planned drug development programs, meet its administrative expense requirements, capital costs, or staffing costs without accessing approximately $12 million (as per current management’s budgets) of our remaining financing available with Aspire Capital. This does not include any budgeted amounts for further development of the Polymedix assets.
 
Management intends to use capital and debt financing, as required, to fund the Company's operations. There can be no assurance that the Company will be able to obtain the additional capital resources on terms and conditions acceptable to the Company to fund its anticipated obligations for the next twelve (12) months. 

 
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Subsequent Events

From April 1, 2014 to May 8, 2014, the Company has generated additional proceeds of approximately $1,402,000 under the Common Stock Purchase Agreement with Aspire on the sale 900,000 shares of its common stock.

On April 1, 2014 the Board of Directors approved the stock option grant to purchase 40,000 shares of common stock at a price of $1.64 per share to one consultant. The option was vested on April 1, 2014 and the option life is 5 years and will expire on March 31, 2019. In addition, the Company will pay $20,000 per month for the six month period from January 7, 2014 to July 6, 2014.

On April 30, 2014, the Company received an exercise notice from a warrant holder for exercise of 200,000 warrants and the Company received the $200,000 on May 2, 2014.

Off-Balance Sheet Arrangements

The Company does not have any off-balance sheet arrangements, as defined in Item 304(a)(4)(ii) of Regulation S-K under the Securities Exchange Act of 1934, as amended.
 
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
We did not have any market risk sensitive instruments outstanding during this period.
 
ITEM 4. CONTROLS AND PROCEDURES
 
The Company’s Chief Executive Officer and Chief Financial Officer have evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of March 31, 2014 covered by this Quarterly Report on Form 10-Q. Based upon such evaluation, the Chief Executive Officer and Chief Financial Officer have concluded that, as of the end of such period, the Company’s disclosure controls and procedures were not effective as required under Rules 13a-15(e) and 15d-15(e) under the Exchange Act.
 
A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis. Management has determined that material weaknesses exist due to:
 
 
●   
The Company lacks the necessary corporate accounting resources to maintain adequate segregation of duties. Reliance on these limited resources impairs Company’s ability to provide for proper segregation of duties and the ability to ensure consistently complete and accurate financial reporting, as well as disclosure controls and procedures.

 
●  
Lack of sufficient accounting expertise to appropriately apply GAAP for complex or non-recurring equity transactions.
 
The Company believes that the two deficiencies set forth above did not have an effect on the financial statements.
 
 
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Management’s Remediation Initiatives
 
In an effort to remediate the identified material weaknesses and other deficiencies and enhance our internal controls, we plan to initiate the following series of measures when we have the financial resources to do so:
 
We will create a position to segregate duties consistent with control objectives and will increase our personnel resources and technical accounting expertise within the accounting function.
 
Management believes that the appointment of one or more outside Directors, who shall be appointed to a fully functioning audit committee, would remedy the lack of a functioning audit committee and a lack of a majority of outside directors on our Board.
 
Changes in Internal Control over Financial Reporting
 
No change in the Company’s internal control over financial reporting occurred during the quarter ended March 31, 2014, that materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
 
ITEM 1. LEGAL PROCEEDINGS
 
Formatech is a former vendor of ours which had received 184,375 shares of Cellceutix Class A Common Stock (“Cellceutix Stock”) for services that were not completed. Formatech had gone bankrupt while still in possession of the Cellceutix Stock. In July 2012, the US Bankruptcy Court allowed the trustee of the Formatech estate to sell the Cellceutix Stock. We have been advised that the stock had been sold in 2013 and the funds released to the secured creditors of Formatech. Cellceutix presently is in the unsecured creditors class and does not expect to receive any proceeds, but the court case as of this date still remains open.
 
From time to time, the Company may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. However, litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm its business. The Company is not currently aware of any other legal proceedings or claims that they believe will have, individually or in the aggregate, a material adverse effect on its business, financial condition or operating results.
 
ITEM 1A. RISK FACTORS
 
Investing in the Company's common stock involves a high degree of risk. Prospective investors should carefully consider the risks described below, together with all of the other information included or referred to in our Annual Report on Form 10-K, before purchasing shares of the Company's common stock. There are numerous and varied risks, known and unknown, that may prevent the Company from achieving its goals. The risks described below are not the only ones the Company will face. If any of these risks actually occur, the Company's business, financial condition or results of operation may be materially adversely affected. In such case, the trading price of the Company's common stock could decline and investors in the Company's common stock could lose all or part of their investment.
 
Risks Specific to Us
 
We need to raise substantial additional capital in the future to fund our operations and we may be unable to raise such funds when needed and on acceptable terms, which could prevent us from fully implementing our business, operating and development plans.
 
We currently have an approximate $5.1 million cash balance in the bank but that is insufficient to complete the development and commercialization of any of our proposed products. We expect to incur costs of approximately $16.8 million in the upcoming twelve (12) months to operate our business in accordance with our business plans and budgets.

 
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On October 25, 2013 we entered into a Purchase Agreement with Aspire Capital which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $20 million of our shares of Class A Common Stock over the approximately 36-month term of the Purchase Agreement. The extent to which we utilize the Purchase Agreement as a source of funding will depend on a number of factors, including the prevailing market price of our Class A Common Stock, the volume of trading in our Class A Common Stock and the extent to which we are able to secure funds from other sources. The number of shares that we may sell to Aspire Capital under the Purchase Agreement on any given day and during the term of the Purchase Agreement is limited. See the Section entitled “Selling Stockholders - The Aspire Transaction” of this prospectus for additional information. Additionally, we and Aspire Capital may not affect any sales of shares of our Class A Common Stock under the Purchase Agreement during the continuance of an event of default or on any trading day that the closing price of our stock falls below $0.25 per share. Even if we are able to access the full $20,000,000 under the Purchase Agreement, we will still need additional capital to fully implement our business, operating and development plans.

Previously on December 6, 2012, we entered into a Common Stock Purchase Agreement with Aspire Capital pursuant to which Aspire Capital committed to purchase up to an aggregate of $10 million of our shares of Class A Common Stock over three years. On October 23, 2013, Aspire Capital completed its purchase of the full $10 million available under that agreement. However, there is no guarantee that we will be able to access the full $20 million available under the new Purchase Agreement in the same manner given the limitations and conditions described above.
 
If we raise additional funds by issuing equity securities, our stockholders will experience dilution. Debt financing, if available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any debt financing or additional equity that we raise may contain terms, such as liquidation and other preferences, which are not favorable to us or our stockholders. If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish valuable rights to our technologies, future revenue streams or product candidates or to grant licenses on terms that may not be favorable to us. Should the financing we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, our business, operating results, financial condition and prospects could be materially and adversely affected and we may be unable to continue our operations.
 
We may be unable to secure this amount of financing on terms and conditions acceptable to the Company. In the event that we cannot obtain acceptable financing, we would be unable to complete preclinical development projects, and clinical trials for Kevetrin, Prurisol, and Brilacidin. This will delay:
 
 
●
research and development programs;
 
 
●
preclinical studies and clinical trials; material characterization studies, regulatory processes;
 
 
●
establishment of our own laboratory or a search for third party marketing partners to market our products for us.
 
The amount of capital we may require will depend on many factors, including the:
 
 
●
progress, timing and scope of our research and development programs;
 
 
●
progress, timing and scope of our preclinical studies and clinical trials;
 
 
●
time and cost necessary to obtain regulatory approvals;
 
 
●
time and cost necessary to establish our own marketing capabilities or to seek marketing partners;
 
 
●
time and cost necessary to respond to technological and market developments;
 
 
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●
changes made or new developments in our existing collaborative, licensing and
 
 
●
other commercial relationships; and
 
 
●
new collaborative, licensing and other commercial relationships that we may establish.

Our fixed expenses, such as rent and other contractual commitments, may increase in the future, as we may:
 
 
●
enter into leases for new facilities and capital equipment;
 
 
●
enter into additional licenses and collaborative agreements; and
 
 
●
incur additional expenses associated with being a public company.
 
We have identified material weaknesses in our internal control over financial reporting. If we fail to remediate these material weaknesses and maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired, which could adversely affect our operating results, our ability to operate our business and investors’ and customers’ views of us.
 
As previously disclosed in our Annual Report on Form 10-K for the year ended June 30, 2013, filed with the SEC on September 30, 2013, we identified a material weakness in our internal control over financial reporting. In connection with our fiscal 2013 audit, we concluded that we did not have sufficient personnel in place for an adequate amount of time or effective operating internal control procedures to ensure timely and accurate reviews necessary to provide reasonable assurance that financial statements and related disclosures could be prepared in accordance with generally accepted accounting principles. Although we have added personnel to help with internal controls and procedures, we concluded that we had not yet fully remediated the weakness previously identified. For a discussion of the material weakness and our remediation efforts during 2013 as well as ongoing remediation efforts, see Item 9A, Controls and Procedures, of the Annual Report on Form 10-K. We cannot assure you that our efforts to fully remediate these internal control weaknesses will be successful or that similar material weaknesses will not recur.
 
The report of our independent registered public accounting firm includes a going concern opinion, and we may not be profitable in the future, if ever. 
 
As of March 31, 2014, we had approximately $5.1 million of cash available to support operations or our business plan. Our operating cash needs, cash consumption, and doubt as to whether we will ever become profitable, are factors which raise substantial doubt as to our ability to continue as a going concern. Consequently, our independent registered public accounting firm has included a going concern paragraph in its audit report which is included in our Annual Report on Form 10-K for our fiscal year ended June 30, 2013. It is uncertain at this time how the going concern language by our independent registered public accounting firm will affect our ability to raise capital. If we are unable to achieve revenues or obtain financing on terms and conditions acceptable to the Company, then we may not be able to commence revenue-generating operations or continue as an on-going concern. 
 
The sale of our Class A Common Stock to Aspire Capital may cause substantial dilution to our existing stockholders and the sale of the shares of Class A Common Stock acquired by Aspire Capital could cause the price of our Class A Common Stock to decline, which could have a materially adverse effect on our business.
 
We have registered for sale the Commitment Shares that we have issued to Aspire Capital, and an additional 13,789,477 shares of Class A Common stock that we may sell to Aspire Capital under the Purchase Agreement. It is anticipated that shares registered in this offering will be sold over a period of up to approximately 36 months from October 25, 2013, the date of the signing of the Purchase Agreement. The number of shares ultimately offered for sale by Aspire Capital under this prospectus is dependent upon the number of shares we elect to sell to Aspire Capital under the Purchase Agreement. Depending upon market liquidity at the time, sales of shares of our Class A Common Stock under the Purchase Agreement may cause the trading price of our Class A Common Stock to decline.

 
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During the three months ended March 31, 2014, the Company had completed sales to Aspire totaling 900,000 shares of common stock generating gross proceeds of approximately $1.6 million. As of March 31, 2014, a balance of $18.4 million remains and is available under the financing arrangement. From April 1, 2014 to May 8, 2014, the Company has generated additional proceeds of approximately $1,402,000 under the Common Stock Purchase Agreement with Aspire on the sale 900,000 shares of its common stock.
 
Aspire Capital may ultimately purchase all, some or none of the Class A Common Stock that, together with the Commitment Shares, is the subject of this prospectus. Aspire Capital may sell all, some or none of our shares that it holds or comes to hold under the Purchase Agreement. Sales by Aspire Capital of shares acquired pursuant to the Purchase Agreement under the registration statement, of which this prospectus is a part, may result in dilution to the interests of other holders of our Class A Common Stock. The sale of a substantial number of shares of our Class A Common Stock by Aspire Capital in this offering, or anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales. However, we have the right to control the timing and amount of sales of our shares to Aspire Capital, and the Purchase Agreement may be terminated by us at any time at our discretion without any penalty or cost to us.
 
All of our Polymedix drug product candidates are licensed from or based upon licenses from the University of Pennsylvania. Upon our purchase of the Polymedix Assets we assumed all contractual rights and obligations of the licenses. If any of these license agreements are terminated, our ability to advance our Polymedix product candidates or develop new product candidates will be materially adversely affected which could have a materially adverse effect on our business.
 
We now depend, and will continue to depend, on our Polymedix licenses and potentially on other licensing arrangements and/or strategic relationships with third parties for the research, development, manufacturing and commercialization of our Polymedix product candidates. If any of our licenses or relationships are terminated or breached, we may:
 
 
●
lose our rights to develop and market our Polymedix product candidates;
 
●
lose patent and/or trade secret protection for our Polymedix product candidates;
 
●
experience significant delays in the development or commercialization of our Polymedix product candidates;
 
●
not be able to obtain any other licenses on acceptable terms, if at all; and/or
 
●
incur liability for damages.
 
If we experience any of the foregoing, it could have a materially adverse effect on our business and could force us to cease operations which could cause you to lose all of your investment.
 
We are a development stage company and have no products approved for commercial sale, have never generated any revenues, and may never achieve revenues or profitability.
 
We are a development stage biopharmaceutical company. Currently, we have no products approved for commercial sale and, to date, we have not generated any revenues. Our ability to generate revenue depends heavily on:
 
 
●
successful demonstration in clinical trials that our drug candidates, Kevetrin, Prurisol, and Brilacidin are safe and effective;
 
●
our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking;
 
●
the successful commercialization of our product candidates; and
 
●
market acceptance of our products.
 
 
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If we do not successfully develop and commercialize at least one of our compounds, we will not achieve revenues or profitability in the foreseeable future, if at all. If we are unable to generate revenues or achieve profitability, we may be unable to continue our operations. 
 
We are a development stage company with a limited operating history, making it difficult for you to evaluate our business and your investment, and we may never generate any revenue which could cause us to cease operations.
 
We are in the development stage and our operations and the development of our proposed products are subject to all of the risks inherent in the establishment of a new business enterprise, including but not limited to: 
 
 
●
the absence of an operating history; 
 
 
●
the lack of commercialized products; 
 
 
●
insufficient capital;
 
 
●
expected substantial and continual losses for the foreseeable future; 
 
 
●
limited experience in dealing with regulatory issues; 
 
 
●
the lack of manufacturing experience and limited marketing experience;
 
 
●
possible reliance on third parties for the development and commercialization of our proposed products;
 
 
●
a competitive environment characterized by numerous, well-established and well capitalized competitors; and 
 
 
●
reliance on key personnel. 
 
Because we are subject to these risks, you may have a difficult time evaluating our business and your investment in our Company. Our ability to become profitable depends primarily on the following factors:
 
 
●
our ability to develop drugs, obtain approval for such drugs, and if approved, to successfully commercialize our drugs;
 
 
●
our R&D efforts, including the timing and cost of clinical trials; and
 
 
●
our ability to enter into favorable alliances with third-parties who can provide substantial capabilities in clinical development, regulatory affairs, sales, marketing and distribution. 

Even if we successfully develop and market our drug candidates, we may not generate sufficient or sustainable revenue to achieve or sustain profitability, which could cause us to cease operations.
 
 
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We have limited experience in drug development and may not be able to successfully develop any drugs. 
 
We have limited experience in drug development and may not be able to successfully develop any drugs. Our ability to achieve revenues and profitability in our business will depend, among other things, on our ability to:
 
 
●
develop products internally or obtain rights to them from others on favorable terms; 
 
 
 
●
complete laboratory testing and human studies; 
 
 
 
●
obtain and maintain necessary intellectual property rights to our products; 
 
 
 
●
successfully complete regulatory review to obtain requisite governmental agency approvals 
 
 
 
●
enter into arrangements with third parties to manufacture our products on our behalf; and 
 
 
 
●
enter into arrangements with third parties to provide sales and marketing functions. 
 
If we are unable to achieve revenues and profitability, then we will be forced to cease operations which could cause you to lose all of your investment.
 
Development of pharmaceutical products is a time-consuming process, subject to a number of factors, many of which are outside of our control. Consequently, we can provide no assurance of the successful and timely development of new drugs, and the failure to do so could cause us to cease operations.
 
Our drug candidates are in developmental and phase 1 and 2 clinical stages but have not yet reached the most important clinical phase 3 stage. Further development and extensive testing will be required to determine their technical feasibility and commercial viability. Our success will depend on our ability to achieve scientific and technological advances and to translate such advances into reliable, commercially competitive drugs on a timely basis. Drugs that we may develop are not likely to be commercially available for several years, if ever. The proposed development schedules for our drug candidates may be affected by a variety of factors, including technological difficulties, proprietary technology of others, and changes in government regulation, many of which will not be within our control. Any delay in the development, introduction or marketing of our drug candidates could result either in such drugs being marketed at a time when their cost and performance characteristics would not be competitive in the marketplace or in the shortening of their commercial lives. In light of the long-term nature of our projects, the unproven technology involved and the other factors described elsewhere in “Risk Factors”, we may not be able to complete successfully the development or marketing of any of our drug candidates. 
 
We may fail to successfully develop and commercialize our drug candidates because they:
 
 
●
are found to be unsafe or ineffective in clinical trials; 
 
 
 
●
do not receive necessary approval from the FDA or foreign regulatory agencies; 
 
 
 
●
fail to conform to a changing standard of care for the diseases they seek to treat; or 
 
 
 
●
are less effective or more expensive than current or alternative treatment methods.

 
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Drug development failure can occur at any stage of clinical trials and as a result of many factors and there can be no assurance that we will reach our anticipated clinical targets. Even if we complete our clinical trials, we do not know what the long-term effects of exposure to our drug candidates will be. Furthermore, our drug candidates may be used in combination with other treatments and there can be no assurance that such use will not lead to unique safety issues. Failure to complete clinical trials or to prove that our drug candidates are safe and effective would have a material adverse effect on our ability to generate revenue and could require us to reduce the scope of or discontinue our operations, which could cause you to lose all of your investment.
 
We must comply with significant and complex government regulations, compliance with which may delay or prevent the commercialization of our drug candidates which could have a materially adverse effect on our business.
 
The R&D, manufacture and marketing of drug candidates are subject to regulation, primarily by the FDA in the United States, and by comparable authorities in other countries. These national agencies and other federal, state, local and foreign entities regulate, among other things, R&D activities (including testing in animals and in humans) and the testing, manufacturing, handling, labeling, storage, record keeping, approval, advertising and promotion of the products that we are developing. Noncompliance with applicable requirements can result in various adverse consequences, including approval delays or refusals to approve drug licenses or other applications, suspension or termination of clinical investigations, revocation of approvals previously granted, fines, criminal prosecution, recalls or seizures of products, injunctions against shipping drugs and total or partial suspension of production and/or refusal to allow a company to enter into governmental supply contracts. 
 
The process of obtaining FDA approval for a drug has historically been costly and time consuming. Current FDA requirements for a new human drug or biological product to be marketed in the United States include: (i) the successful conclusion of pre-clinical laboratory and animal tests, if appropriate, to gain preliminary information on the product's safety; (ii) filing with the FDA of an IND application to conduct human clinical trials for drugs or biologics; (iii) the successful completion of adequate and well-controlled human clinical investigations to establish the safety and efficacy of the product for its recommended use; and (iv) filing by a company and acceptance and approval by the FDA of a New Drug Application (“NDA”), for a drug product or a biological license application (“BLA”), for a biological product to allow commercial distribution of the drug or biologic. A delay in one or more of the procedural steps outlined above could be harmful to the Company in terms of getting our drug candidates through clinical testing and to market. 
 
The FDA reviews the results of the clinical trials and may order the temporary or permanent discontinuation of clinical trials at any time if it believes the drug candidate exposes clinical subjects to an unacceptable health risk. Investigational drugs used in clinical studies must be produced in compliance with current good manufacturing practice (“cGMP”) rules pursuant to FDA regulations. 
 
Sales outside the United States of products that we develop will also be subject to additional regulatory requirements governing human clinical trials and marketing for drugs and biological products and devices. The requirements vary widely from country to country, but typically the registration and approval process takes several years and requires significant resources.
 
We also are subject to the following risks and obligations, related to the approval of our products:
 
 
●  
The FDA or foreign regulators may interpret data from pre-clinical testing and clinical trials in different ways than we interpret them. 
 
●  
If regulatory approval of a product is granted, the approval may be limited to specific indications or limited with respect to its distribution. In addition, many foreign countries control pricing and coverage under their respective national social security systems. 
 
●
The FDA or foreign regulators may not approve our manufacturing processes or manufacturing facilities.
 
●
The FDA or foreign regulators may change their approval policies or adopt new regulations. 
 
●
Even if regulatory approval for any of our product is obtained, the corresponding marketing license will be subject to continual review, and newly discovered or developed safety or effectiveness data may result in suspension or revocation of the marketing license.
 
●
If regulatory approval of the product candidate is granted, the marketing of that product would be subject to adverse event reporting requirements and a general prohibition against promoting products for unapproved uses. 
 
●
In some foreign countries, we may be subject to official release requirements that require each batch of the product we produce to be officially released by regulatory authorities prior to its distribution by us. 
 
●
We will be subject to continual regulatory review and periodic inspection and approval of manufacturing modifications, including compliance with cGMP regulations. 

 
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If we do not have the requisite resources to comply with all applicable regulations, then we could be forced to cease operations which could cause you to lose all of your investment.
 
Even if we were to successfully develop approvable drugs, we will not be able to sell these drugs if we or our third party manufacturers fail to comply with manufacturing regulations . 
 
If we were to successfully develop approvable drugs, before we can begin selling these drugs, we must obtain regulatory approval of our cGMP manufacturing facility and process or the cGMP manufacturing facility and process of the third party or parties with whom we may outsource our manufacturing activities. The cGMP regulations govern quality control and documentation policies and procedures. Our manufacturing facilities, if any in the future, and the manufacturing facilities of our third party manufacturers will be continually subject to inspection by the FDA and other state, local and foreign regulatory authorities, before and after product approval. We cannot guarantee that we, or any potential third party manufacturer of our products, will be able to comply with the cGMP regulations or other applicable manufacturing regulations, and any failure to comply could have a materially adverse effect on our business.
 
We can provide no assurance that our drug candidates will obtain regulatory approval or that the results of clinical studies will be favorable, and if we fail to obtain such approval or if clinical studies are not favorable, we could be forced to cease operations.
 
Presently, we are in a Phase 1 clinical trial for Kevetrin, our anti-cancer drug; a Phase 1 study for Prurisol (anti-psoriasis); and a Phase 2b for Brilacidin (ABSSSI). The work-plan we have developed for the next twelve (12) months should enable us to advance Kevetrin’s clinical trial to Phase 2; commence Phase 2 clinical trials for Prurisol; commence Phase 3 clinical trials for Brilacidin (ABSSSI); and commence Phase 2 for Brilacidin-OM (oral mucositis).
 
The testing, marketing and manufacturing of any product for use in the United States will require approval from the FDA. We cannot predict with any certainty the amount of time necessary to obtain such FDA approval and whether any such approval will ultimately be granted. Preclinical and clinical trials may reveal that one or more products are ineffective or unsafe, in which event further development of such products could be seriously delayed or terminated. Moreover, obtaining approval for certain products may require testing on human subjects of substances whose effects on humans are not fully understood or documented. Delays in obtaining FDA or any other necessary regulatory approvals of any proposed drugs, and failure to receive such approvals, would have an adverse effect on the drug's potential commercial success and on our business, prospects, financial condition and results of operations. In addition, it is possible that a proposed drug may be found to be ineffective or unsafe due to conditions or facts that arise after development has been completed and regulatory approvals have been obtained. In this event, we may be required to withdraw such proposed drug from the market. To the extent that our success will depend on any regulatory approvals from government authorities outside of the United States that perform roles similar to that of the FDA, uncertainties similar to those stated above will also exist.
 
Even if our product candidate Prurisol receives regulatory approval, commercialization may be adversely affected by regulatory actions requiring a boxed warning, which could have a materially adverse effect on our business.
 
Even if we receive regulatory approval for our psoriasis product candidate Prurisol, we expect an approval to include a boxed warning regarding possible severe health risks and side effects. Products with boxed warnings are subject to more restrictive regulations than products without such warnings. Boxed restrictions would make it more difficult to market Prurisol, and the added regulation could require us to expend resources that we may not have which could delay or prevent commercialization of that product which could have a materially adverse effect on our business.
 
 
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Even if we obtain regulatory approvals, our marketed drug candidates will be subject to ongoing regulatory review. If we fail to comply with continuing U.S. and foreign regulations, we could lose our approvals to market these drugs and our business would be seriously harmed.
 
Following any initial regulatory approval of any drugs we may develop, we will also be subject to continuing regulatory review, including the review of adverse experiences and clinical results that are reported after our drug candidates are made commercially available. This would include results from any post-marketing tests or vigilance required as a condition of approval. The manufacturer and manufacturing facilities we contract with to make any of our drug candidates will also be subject to periodic review and inspection by the FDA. The discovery of any previously unknown problems with the drug, manufacturer or facility may result in restrictions on the drug or manufacturer or facility, including withdrawal of the drug from the market. We do not have, and currently do not intend to develop, the ability to manufacture material for our clinical trials or on a commercial scale. Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured drugs ourselves, including reliance on the third-party manufacturer for regulatory compliance. Our drug promotion and advertising is also subject to regulatory requirements and continuing FDA review. If we are required to withdraw all or more of our drugs from the market as a result of actions or inactions on the part of the Company or a third party, we may be unable to continue revenue generating operations which could cause you to lose all of your investment.

We have limited experience in conducting or supervising clinical trials and must outsource all clinical trials, which expose us to risks which could have a materially adverse effect on our business.
 
We have acquired limited experience in conducting and supervising clinical trials that must be performed to obtain data to submit in concert with applications for approval by the FDA. The regulatory process to obtain approval for drugs for commercial sale involves numerous steps. Drugs are subjected to clinical trials that allow development of case studies to examine safety, efficacy, and other issues to ensure that sale of drugs meets the requirements set forth by various governmental agencies, including the FDA. In the event that our protocols do not meet standards set forth by the FDA, or that our data is not sufficient to allow such trials to validate our drugs in the face of such examination, we might not be able to meet the requirements that allow our drugs to be approved for sale, which could have a materially adverse effect on our business.
 
Because we have limited experience in conducting or supervising clinical trials, we outsource a significant amount of the work relating to our clinical trials to third parties. We have no control over their compliance with procedures and protocols used to complete clinical trials in accordance with standards required by the agencies that approve drugs for sale. If these subcontractors fail to meet these standards, the validation of our drugs would be adversely affected, causing a delay in our ability to engage in revenue-generating operations which could have a materially adverse effect on our business.
 
We are subject to risks inherent in conducting clinical trials. The risk of non compliance with FDA-approved good clinical practices by clinical investigators, clinical sites, or data management services could delay or prevent us from developing or ever commercializing our drug candidates, which could cause us to cease operations.
 
Agreements with clinical investigators and medical institutions for clinical testing and with other third parties for data management services place substantial responsibilities on these parties, which could result in delays in, or termination of, our clinical trials if these parties fail to perform as expected. For example, if any of our clinical trial sites fail to comply with FDA-approved good clinical practices, we may be unable to use the data gathered at those sites. If these clinical investigators, medical institutions or other third parties do not carry out their contractual duties or obligations or fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to their failure to adhere to our clinical protocols or for other reasons, our clinical trials may be extended, delayed or terminated, and we may be unable to obtain regulatory approval for or successfully commercialize our drug candidates. 
 
We or regulators may suspend or terminate our clinical trials for a number of reasons. We may voluntarily suspend or terminate our clinical trials if at any time we believe that they present an unacceptable risk to the patients enrolled in our clinical trials. In addition, regulatory agencies may order the temporary or permanent discontinuation of our clinical trials at any time if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements or that they present an unacceptable safety risk to the patients enrolled in our clinical trials. In addition, clinical trials may have independent monitoring boards composed of experts in the field. These boards may also have the authority to suspend or terminate clinical trials. 
 
Our clinical trial operations will be subject to regulatory inspections at any time. If regulatory inspectors conclude that we or our clinical trial sites are not in compliance with applicable regulatory requirements for conducting clinical trials, we may receive reports of observations or warning letters detailing deficiencies, and we will be required to implement corrective actions. If regulatory agencies deem our responses to be inadequate, or are dissatisfied with the corrective actions that we or our clinical trial sites have implemented, our clinical trials may be temporarily or permanently discontinued, we may be fined, we or our investigators may be precluded from conducting any ongoing or any future clinical trials, the government may refuse to approve our marketing applications or allow us to manufacture or market our drug candidates or we may be criminally prosecuted. If we are unable to complete clinical trials and have our products approved due to our failure to comply with regulatory requirements, we will be unable to commence revenue generating operations which could force us to cease operations.

 
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The Company is exposed to product liability, clinical and preclinical liability risks which could place a substantial financial burden upon the Company should it be sued. 
 
The Company could be exposed to potential product liability and other liability risks that are inherent in the testing, manufacturing and marketing of pharmaceutical products. In addition, the use in the Company's clinical trials of pharmaceutical products that it may develop and the subsequent sale of these products by the Company or its potential collaborators may cause the Company to bear a portion of or all product liability risks. A successful liability claim or series of claims brought against the Company could have a material adverse effect on its business, financial condition and results of operations.
 
The Company has $5,000,000 in liability insurance for our clinical trials. The Company cannot assure that such insurance will provide adequate coverage against the Company's potential liabilities. Claims or losses in excess of any product liability insurance coverage that may be obtained by the Company could have a material adverse effect on our business, financial condition and results of operations.
 
Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information. Disclosure of our trade secrets or proprietary information could compromise any competitive advantage that we have, which could have a materially adverse effect on our business.
 
We depend upon confidentiality agreements with our officers, employees, consultants, and subcontractors to maintain the proprietary nature of the technology. These measures may not afford us sufficient or complete protection, and may not afford an adequate remedy in the event of an unauthorized disclosure of confidential information. In addition, others may independently develop technology similar to ours, otherwise avoiding the confidentiality agreements, or produce patents that would materially and adversely affect our business, prospects, financial condition, and results of operations.
 
We may be unable to obtain or protect intellectual property rights relating to our products, and we may be liable for infringing upon the intellectual property rights of others, which could have a materially adverse effect on our business.
 
Our ability to compete effectively will depend on our ability to maintain the proprietary nature of our compounds and the proprietary compounds of others with which we have entered into licensing agreements. We have filed two patent applications and expect to file a number of additional patent applications in the coming years. There can be no assurance that any of these patent applications will ultimately result in the issuance of a patent with respect to the proprietary compounds owned by us or licensed to us. The patent position of pharmaceutical or biotechnology companies, including ours, is generally uncertain and involves complex legal and factual considerations. The standards that the United States Patent and Trademark Office use to grant patents are not always applied predictably or uniformly and can change. There is also no uniform, worldwide policy regarding the subject matter and scope of claims granted or allowable in pharmaceutical or biotechnology patents. Accordingly, we do not know the degree of future protection for our proprietary rights or the breadth of claims that will be allowed in any patents issued to us or to others. Further, we rely on a combination of trade secrets, know-how, technology and nondisclosure, and other contractual agreements and technical measures to protect our rights in the proprietary compounds. If any trade secret, know-how or other proprietary information and/or compounds not protected by a patent were to be disclosed to or independently developed by a competitor, our business and financial condition could be materially adversely affected.
 
We do not believe that any of the drug candidates we are currently developing infringe upon the rights of any third parties nor are they infringed upon by third parties; however, there can be no assurance that our proprietary compounds will not be found in the future to infringe upon the rights of others or be infringed upon by others. In such a case, others may assert infringement claims against us, and should we be found to infringe upon their patents, or otherwise impermissibly utilize their intellectual property, we might be forced to pay damages, potentially including treble damages, if we are found to have willfully infringed on such parties' patent rights. In addition to any damages we might have to pay, we may be required to obtain licenses from the holders of this intellectual property, enter into royalty agreements, or redesign our drug candidates so as not to utilize this intellectual property, each of which may prove to be uneconomical or otherwise impossible. Conversely, we may not always be able to successfully pursue our claims against others that infringe upon our proprietary compounds. Thus, the proprietary nature of our technology or technology licensed by us may not provide adequate protection against competitors. 
 
Moreover, the cost to us of any litigation or other proceeding relating to our patents and other intellectual property rights, even if resolved in our favor, could be substantial, and the litigation would divert our management's efforts. Uncertainties resulting from the initiation and continuation of any litigation could limit our ability to continue our operations.
 
 
43
 
 
Our potential collaborative relationships with third parties could cause us to expend significant resources and incur substantial business risk with no assurance of financial return, which could have a materially adverse effect on our business. 
 
We may have to rely substantially upon strategic collaborations for marketing and the commercialization of our drug candidates, and we may rely even more on strategic collaborations for R&D of our other drug candidates. Our business will depend on our ability to sell drugs to both government agencies and to the general pharmaceutical market. We may have to sell our drugs through strategic partnerships with pharmaceutical companies. If we are unable to establish or manage such strategic collaborations on terms favorable to us in the future, our revenue and drug development may be limited. To date, we have not entered into any strategic collaboration with third parties capable of providing these services. In addition, we have not yet marketed or sold any of our drug candidates or entered into successful collaborations for these services in order to ultimately commercialize our drug candidates. 
 
If we determine to enter into R&D collaborations during the early phases of drug development, our success will in part depend on the performance of our research collaborators. We will not directly control the amount or timing of resources devoted by our research collaborators to activities related to our drug candidates. Our research collaborators may not commit sufficient resources to our programs. If any research collaborator fails to commit sufficient resources, our preclinical or clinical development programs related to this collaboration could be delayed or terminated. Also, our collaborators may pursue existing or other development-stage products or alternative technologies in preference to those being developed in collaboration with us. Finally, if we fail to make required milestone or royalty payments to our collaborators, or to observe other obligations in our agreements with them, our collaborators may have the right to terminate those agreements. 
 
Management of our relationships with our collaborators will require:
 
 
●
significant time and effort from our management team; 
 
 
 
●
coordination of our marketing and R&D programs with the marketing and R&D priorities of our collaborators; and 
 
 
 
●
effective allocation of our resources to multiple projects. 
 
Establishing strategic collaborations is difficult and time-consuming. Our discussion with potential collaborators may not lead to the establishment of collaborations on favorable terms, if at all. Potential collaborators may reject collaborations based upon their assessment of our financial, regulatory or intellectual property position. Even if we successfully establish new collaborations, these relationships may never result in the successful development or commercialization of our drug candidates or the generation of sales revenue. To the extent that we enter into collaborative arrangements, our drug revenues are likely to be lower than if we directly marketed and sold any drugs that we may develop. 
 
We may not be able to attract and retain highly skilled personnel or consultants, which could have a materially adverse effect on our business. 
 
Our ability to attract and retain highly skilled personnel or consultants is critical to our operations and expansion. We face competition for these types of personnel from other pharmaceutical companies and more established organizations, many of which have significantly larger operations and greater financial, technical, human and other resources than us. We may not be successful in attracting and retaining qualified personnel or consultants on a timely basis, on competitive terms, or at all. If we are not successful in attracting and retaining these personnel or consultants, our business, prospects, financial condition and results of operations will be materially adversely affected.
 
We depend upon our senior management and their loss or unavailability could put us at a competitive disadvantage. 
 
We currently depend upon the efforts and abilities of our management team. On December 29, 2010, the Company entered into employment agreements with its two executive officers, Leo Ehrlich, the Company’s Chief Executive and Financial Officer, and Krishna Menon, Chief Scientific Officer for a period of three years ending on December 31, 2013. On January 1, 2014, the Board of Directors of the Company approved the extension of the Employment Agreements with Leo Ehrlich and Krishna Menon for a one year period with a 10% increase in salary from the previous annual salary of $423,500 each, to an annual salary of $465,850.
 
 
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There are conflicts of interest among our officers, directors and stockholders. 
 
Certain of our executive officers and directors and their affiliates are engaged in other activities and have interests in other entities on their own behalf or on behalf of other persons. Neither we nor any of our stockholders will have any rights in these ventures or their income or profits. In particular:
 
 
●
Our executive officers or directors or their affiliates may have an economic interest in, or other business relationship with, partner companies that invest in us or are engaged in competing drug development; and
 
 
 
●
Previously, Kard Scientific, a company controlled by Dr. Krishna Menon, President and Director, provided preclinical and manufacturing services to the Company and leased space to the Company. 
 
In either of these cases:
 
 
●
Our executive officers or directors may have a conflict between our current interests and their personal financial and other interests in another business venture; and
 
 
 
●
Our executive officers or directors may have conflicting fiduciary duties to us and the other entity. 
 
While the Company is not aware of any conflict that has arisen to date, the Company does not have any policy in place to deal with such should such a conflict arise.
 
The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. We may be unable to compete with enterprises equipped with more substantial resources than us, which could cause us to cease operations.
 
The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition based primarily on scientific and technological factors. These factors include the availability of patent and other protection for technology and products, the ability to commercialize technological developments and the ability to obtain government approval for testing, manufacturing and marketing.
 
We compete with biopharmaceutical firms in the United States, Europe and elsewhere, as well as a growing number of large pharmaceutical companies that are applying biotechnology to their operations. Many biopharmaceutical companies have focused their development efforts in the human therapeutics area, including cancer. Many major pharmaceutical companies have developed or acquired internal biotechnology capabilities or made commercial arrangements with other biopharmaceutical companies. These companies, as well as academic institutions, government agencies and private research organizations, also compete with us in recruiting and retaining highly qualified scientific personnel and consultants. Our ability to compete successfully with other companies in the pharmaceutical field will also depend to a considerable degree on the continuing availability of capital on terms and conditions acceptable to us. 
 
We are aware of numerous products under development or manufactured by competitors that are used for the prevention or treatment of certain diseases we have targeted for drug development. Various companies are developing biopharmaceutical products that potentially directly compete with our drug candidates even though their approach to such treatment is different.
 
For example, with respect to Kevetrin, our lead compound for cancer, there are many drugs approved to treat various cancers and many more in the publicly disclosed pipeline. Our success depends on our ability to identify tumor types where Kevetrin has an advantage over existing therapies and those in the publicly disclosed pipeline. The same is true for our compounds Prurisol and Brilacidin. Numerous drugs are already FDA approved for the treatment of psoriasis and ABSSSI.
 
Our competition will be determined in part by the potential indications for which drugs are developed and ultimately approved by regulatory authorities. Additionally, the timing of the market introduction of some of our potential drugs or of competitors' products may be an important competitive factor. Accordingly, the relative speed with which we can develop drugs, complete pre-clinical testing, clinical trials, approval processes and supply commercial quantities to market are important competitive factors. We expect that competition among drugs approved for sale will be based on various factors, including product efficacy, safety, reliability, availability, price and patent protection. 
 
 
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The successful development of biopharmaceuticals is highly uncertain. A variety of factors including, pre-clinical study results or regulatory approvals, could cause us to abandon development of our drug candidates, which could also cause us to cease operations and you may lose your entire investment.
 
Successful development of biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our control.
 
Products that appear promising in the early phases of development may fail to reach the market for several reasons including:
 
 
●
pre-clinical study results that may show the product to be less effective than desired (e.g., the study failed to meet its primary objectives) or to have harmful or problematic side effects;
 
 
 
●
failure to receive the necessary regulatory approvals or a delay in receiving such approvals. Among other things, such delays may be caused by slow enrollment in clinical studies, length of time to achieve study endpoints, additional time requirements for data analysis or a IND and later NDA, preparation, discussions with the FDA, an FDA request for additional pre-clinical or clinical data or unexpected safety or manufacturing issues; 
 
 
 
●
manufacturing costs, pricing or reimbursement issues, or other factors that make the product not economical; and 
 
 
 
●
the proprietary rights of others and their competing products and technologies that may prevent the product from being commercialized. 
 
Success in pre-clinical and early clinical studies does not ensure that large-scale clinical studies will be successful. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. The length of time necessary to complete clinical studies and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one product to the next, and may be difficult to predict or control.
 
Risks Related to the Securities Markets and Investments in Our Class A Common Stock
 
Because our common stock is  quoted on  the OTC Bulletin Board your ability to sell your shares in the secondary trading market may be limited. 
 
Our Class A Common Stock is currently quoted on the OTC Bulletin Board. Consequently, the liquidity of our Class A Common Stock is impaired, not only in the number of shares that are bought and sold, but also through delays in the timing of transactions, and coverage by security analysts and the news media, if any, of our Company. As a result, prices for shares of our Class A Common Stock may be lower than might otherwise prevail if our Class A Common Stock was quoted and traded on NASDAQ or a national securities exchange. 
 
Because our Class A Common Stock is considered "penny stock" you may have difficulty selling them in the secondary trading market. 
 
Federal regulations under the Securities Exchange Act of 1934 (the “Exchange Act”) regulate the trading of so-called "penny stocks," which are generally defined as any security not listed on a national securities exchange or NASDAQ, priced at less than $5.00 per share and offered by an issuer with limited net tangible assets and revenues. Since our Class A Common Stock currently is quoted on the OTC Bulletin Board at less than $5.00 per share, our shares are "penny stocks" and may not be traded unless a disclosure schedule explaining the penny stock market and the risks associated therewith is delivered to a potential purchaser prior to any trade. 

 
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In addition, because our Class A Common Stock is not listed on NASDAQ or any national securities exchange and currently is quoted at and trades at less than $5.00 per share, trading in our Class A Common Stock is subject to Rule 15g-9 under the Exchange Act. Under this rule, broker-dealers must take certain steps prior to selling a "penny stock," which steps include:
 
 
●
obtaining financial and investment information from the investor; 
 
 
 
●
obtaining a written suitability questionnaire and purchase agreement signed by the investor; and 
 
 
 
●
providing the investor a written identification of the shares being offered and the quantity of the shares. 
 
If these penny stock rules are not followed by the broker-dealer, the investor has no obligation to purchase the shares. The application of these comprehensive rules will make it more difficult for broker-dealers to sell our Class A Common Stock and our stockholders, therefore, may have difficulty in selling their shares in the secondary trading market. 
 
Our stock price may be volatile and your investment in our Class A Common Stock could suffer a decline in value.
 
As of March 31, 2014, the closing price of our Class A Common Stock, as quoted on the OTC Bulletin Board, was $1.64. The price may fluctuate significantly in response to a number of factors, many of which are beyond our control. These factors include:
 
 
●
progress of our products through the regulatory process; 
 
 
 
●
results of preclinical studies and clinical trials;
 
 
 
●
announcements of technological innovations or new products by us or our competitors; 
 
 
 
●
government regulatory action affecting our products or our competitors' products in both the United States and foreign countries; 
 
 
 
●
developments or disputes concerning patent or proprietary rights; 
 
 
 
●
general market conditions for emerging growth and pharmaceutical companies; 
 
 
 
●
economic conditions in the United States or abroad; 
 
 
 
●
actual or anticipated fluctuations in our operating results; 
 
 
 
●
broad market fluctuations; and 
 
 
 
●
changes in financial estimates by securities analysts. 
 
 
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Our directors and executive officers own or control a sufficient number of shares of our Class A Common Stock to control our Company, which could discourage or prevent a takeover, even if an acquisition would be beneficial to our stockholders .
 
At March 31, 2014, our directors and executive officers own or control approximately 38% of our outstanding voting power of Class A Common Stock. Accordingly, these stockholders, individually and as a group, may be able to influence the outcome of stockholder votes, involving votes concerning the election of directors, the adoption or amendment of provisions in our Articles of Incorporation and bylaws and the approval of certain mergers or other similar transactions, such as sales of substantially all of our assets. Such control by existing stockholders could have the effect of delaying, deferring or preventing a change in control of our Company.
 
The dual class structure of our common stock can have the effect of concentrating voting control with Dr. Menon and/ or Mr. Ehrlich, which will limit or preclude your ability to influence corporate matters.
 
Our Class B common stock entitles holders to ten (10) votes per share on all matters submitted to a vote of our stockholders and our Class A Common Stock entitles holders to one (1) vote per share on all matters submitted to a vote of our stockholders. Dr. Menon and Mr. Ehrlich each have vested options that they can exercise and convert into 18,000,000 shares of Class B common stock. That alone could result in the equivalent of 360,000,000 votes of Class A Common Stock. As of March 31, 2014 we had 107,112,129 shares of Class A Common Stock issued and outstanding and no shares of Class B common stock outstanding. Because of the ten-to-one voting ratio between our Class B common stock and Class A Common Stock, upon exercise and conversion of such options into shares of Class B common stock, the Class B common stock holders can collectively control a majority of the combined voting power of our common stock (i.e., approximately 77.1%) and therefore be able to control all matters submitted to our stockholders for approval. This concentrated control will limit or preclude your ability to influence corporate matters for the foreseeable future.
 
We do not intend to pay any cash dividends in the foreseeable future and, therefore, any return on your investment in our Class A Common Stock must come from increases in the fair market value and trading price of the Class A Common Stock. 
 
We have not paid any cash dividends on our Class A Common Stock and do not intend to pay cash dividends on our Class A Common Stock in the foreseeable future. We intend to retain future earnings, if any, for reinvestment in the development and expansion of our business. Any credit agreements, which we may enter into with institutional lenders, may restrict our ability to pay dividends. Whether we pay cash dividends in the future will be at the discretion of our board of directors and will be dependent upon our financial condition, results of operations, capital requirements and any other factors that the board of directors decides is relevant. Therefore, any return on your investment in our Class A Common Stock must come from increases in the fair market value and trading price of the Class A Common Stock. 
 
We may issue additional equity shares to fund the Company's operational requirements which would dilute your share ownership. 
 
The Company's continued viability depends on its ability to raise capital. Changes in economic, regulatory or competitive conditions may lead to cost increases. Management may also determine that it is in the best interest of the Company to develop new services or products. In any such case additional financing is required for the Company to meet its operational requirements. There can be no assurances that the Company will be able to obtain such financing on terms acceptable to the Company and at times required by the Company, if at all. In such event, the Company may be required to materially alter its business plan or curtail all or a part of its operational plans.

 
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Large amounts of our Class A Common Stock will be eligible for resale under Rule 144.
 
As of March 31, 2014, 47,400,200 of the 107,112,129 issued and outstanding shares of our Class A Common Stock are restricted securities as defined under Rule 144 of the Securities Act and under certain circumstances may be resold without registration pursuant to Rule 144.
 
4,964,602 shares of our restricted shares of Class A Common Stock are held by non-affiliates who may avail themselves of the public information requirements and sell their shares in accordance with Rule 144. As a result, some or all of these shares may be sold in accordance with Rule 144 potentially causing the price of the Company's shares to decline.
 
In general, under Rule 144, a person (or persons whose shares are aggregated) who has satisfied a six-month holding period may, under certain circumstances, sell within any three-month period a number of securities which does not exceed the greater of 1% of the then outstanding shares of Class A Common Stock or the average weekly trading volume of the class during the four calendar weeks prior to such sale. Rule 144 also permits, under certain circumstances, the sale of securities, without any limitation, by a person who is not an Affiliate, as such term is defined in Rule 144(a)(1), of the Company and who has satisfied a one-year holding period. Any substantial sale of the Company's Class A Common Stock pursuant to Rule 144 may have an adverse effect on the market price of the Class A Common Stock.
 
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES

On January 23, 2014, the Company issued 25,000 shares of restricted common stock and 25,000 stock options exercisable at $1.79 per share to a consultant. The shares were granted on January 23, 2014 and vested on March 31, 2014. The shares were valued at $44,750 and the option life is three years.

On January 23, 2014, the Company further issued 25,000 shares of restricted Class A common shares, par value $.0001, at $1.79 per share to a consultant. The shares were granted on January 23, 2014 and vested on March 31, 2014. The shares were valued at $44,750.

On March 18, 2014, the Company issued 25,000 Class A common shares, par value $.0001, upon exercise of 25,000 Common Stock options at $0.20 per share, for total proceeds of $5,000.

On March 31, 2014, the Company issued 25,000 shares of restricted Class A common shares, par value $.0001, to a consultant for prior services rendered. The shares were granted and vested on March 31, 2014. The shares were valued at $41,000.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES
 
None
 
ITEM 4. MINE SAFETY DISCLOSURES
 
None
 
ITEM 5. OTHER INFORMATION
 
None
 
 
49
 
 
ITEM 6. EXHIBITS
 
(a)   Exhibit index
 
Exhibit    
     
10.37  
Intellectual Property Acquired from Polymedix
     
10.38  
Material Transfer Agreement with Beth Israel Deaconess
     
10.39  
Lease Between Cellceutix Corporation And Cummings Properties LLC
     
31.1  
Certification of Chief Executive Officer, Chief Financial Officer, Chief Accounting Officer required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.
     
31.2  
Certification of Chief Executive Officer, Chief Financial Officer, Chief Accounting Officer required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.
 
32.1  
Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code)
     
32.2    Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code)
     
101.INS **   XBRL Instance Document.
     
101.SCH **   XBRL Taxonomy Extension Schema Document
     
101.CAL **   XBRL Taxonomy Extension Calculation Linkbase Document
     
101.DEF **   XBRL Taxonomy Extension Definition Linkbase Document
     
101.LAB **   XBRL Taxonomy Extension Label Linkbase Document
     
101.PRE **   XBRL Taxonomy Extension Presentation Linkbase Document
 
** XBRL (Extensible Business Reporting Language) information is furnished and not filed or a part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and otherwise is not subject to liability under these sections.
 
 
50
 
 
SIGNATURES
 
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
 
  CELLCEUTIX CORPORATION  
       
Dated: May 12, 2014
By:
/s/ Leo Ehrlich  
    Leo Ehrlich, Chief Executive Officer and Chief Financial Officer and Chairman of the Board of Directors  
    (Principal Executive, Accounting and Financial Officer)  
       
       
 
By:
/s/ Krishna Menon  
    Krishna Menon,  
    President and Director  
 
 
 
51 
EXHIBIT 31.1

CERTIFICATION
 
I, Krishna Menon, certify:
 
1.  
I have reviewed this Quarterly Report on Form 10-Q of Cellceutix Corporation for the quarter ended March 31, 2014;

2.  
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.  
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the small business issuer as of, and for, the periods presented in this report;

4.  
The issuer’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the small business issuer and have:

 
(a)  
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the small business issuer, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 
(b)  
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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;

 
(c)  
Evaluated the effectiveness of the small business issuer’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 
(d)  
Disclosed in this report any change in the small business issuer’s internal control over financial reporting that occurred during the small business issuer’s most recent fiscal quarter (the small business issuer’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the small business issuer’s internal control over financial reporting; and

5.  
The issuer’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the small business issuer’s auditors and the audit committee of the small business issuer’s board of directors (or persons performing the equivalent functions):

 
(a)  
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the small business issuer’s ability to record, process, summarize and report financial information; and

 
(b)  
Any fraud, whether or not material, that involves management or other employees who have a significant role in the small business issuer’s internal control over financial reporting.
 
       
Dated: May 12, 2014
By:
/s/ Krishna Menon  
    Krishna Menon  
    President and Director  
       
EXHIBIT 31.2
 
CERTIFICATION
 
I, Leo Ehrlich, certify:
 
1.  
I have reviewed this Quarterly Report on Form 10-Q of Cellceutix Corporation for the quarter ended March 31, 2014;

2.  
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.  
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the small business issuer as of, and for, the periods presented in this report;

4.  
The issuer’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the small business issuer and have:

 
(a)  
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the small business issuer, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 
(b)  
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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;

 
(c)  
Evaluated the effectiveness of the small business issuer’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 
(d)  
Disclosed in this report any change in the small business issuer’s internal control over financial reporting that occurred during the small business issuer’s most recent fiscal quarter (the small business issuer’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the small business issuer’s internal control over financial reporting; and

5.  
The issuer’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the small business issuer’s auditors and the audit committee of the small business issuer’s board of directors (or persons performing the equivalent functions):

 
(a)  
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the small business issuer’s ability to record, process, summarize and report financial information; and

 
(b)  
Any fraud, whether or not material, that involves management or other employees who have a significant role in the small business issuer’s internal control over financial reporting.
 
       
Dated: May 12, 2014
By:
/s/ Leo Ehrlich  
    Leo Ehrlich  
    Chief Executive Officer and Chief Financial Officer and Chairman of the Board of Directors (Principal Executive, Accounting and Financial Officer)  
       
EXHIBIT 32.1
 
Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
 
(Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code)
 
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), each of the undersigned officers of Cellceutix Corporation, a Nevada corporation (the "Company"), does hereby certify, to such officer's knowledge, that: 
 
The Quarterly Report on Form 10-Q for the quarter ended March 31, 2014 of the Company fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934 and the information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company. 
 
A signed original of this written statement required by Section 906 has been provided to Cellceutix Corporation and will be retained by Cellceutix Corporation and furnished to the Securities and Exchange Commission or its staff upon request. 
 
       
Dated: May 12, 2014
By:
/s/ Krishna Menon  
    Krishna Menon  
    President and Director  
       
EXHIBIT 32.2
   
Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
 
(Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code)
 
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), each of the undersigned officers of Cellceutix Corporation, a Nevada corporation (the "Company"), does hereby certify, to such officer's knowledge, that: 
 
The Quarterly Report on Form 10-Q for the quarter ended March 31, 2014 of the Company fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934 and the information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company. 
 
A signed original of this written statement required by Section 906 has been provided to Cellceutix Corporation and will be retained by Cellceutix Corporation and furnished to the Securities and Exchange Commission or its staff upon request.
 
       
Dated: May 12, 2014
By:
/s/ Leo Ehrlich  
    Leo Ehrlich  
    Chief Executive Officer and Chief Financial Officer and Chairman of the Board of Directors (Principal Executive, Accounting and Financial Officer)  
       
 
EXHIBIT 10.37
 
Intellectual Property Acquired from Polymedix

The intellectual property portfolio of the former Polymedix which we acquired consists of the following:

CATAGORIES
 
1.
Brilacidin, and related compounds
2.
Delparantag and related compounds
3.
Anti-microbial- surfactants and related compounds
 
Patent
Status
Description
COMPOSITION AND USE PATENTS
Design, preparation and properties of antibacterial beta-peptides. (1)
United States - Issued 01/13/04
Category: 1
Patent expires: 2020
This patent claims composition of matter for particular beta-peptides that have antibacterial properties.  It also claims pharmaceutical preparations containing particular antibacterial beta-peptides and methods for creating sanitizing surfaces by treatment with an antibacterial beta-peptide.
Amphiphilic Polymers as Anti-Infective Agents: 1 (1)
 
United States – filed
Patent Cooperation Treaty – filed
National Phase entered
United States - issued 02/06/2007
European Patent - issued 09/17/2008
Other issued patents include Australia, China, Japan, South Korea
 
Category: 1 & 3
Patents expire: 2022
These patents and application family claims composition of matter for facially amphiphilic polymers that are polyamides, polyesters, polyurea, polyurethane, polycarbonate, or polyphenylene, compounds.  Also claimed are material articles made from the amphiphilic polymers that have antimicrobial properties.
 
Amphiphilic Polymers as Anti-Infective Agents: 2 (Phenylalkynes) (1)
 
United States – filed
 
Patent Cooperation Treaty – filed
 
National Phase entered
 
European Patent - issued 05/25/2011
 
Other issued patents: Australia, South Korea
 
European Divisional filed
 
Other divisional filings: Japan, China
 
Category: 1 & 3
Patents expire: 2022
These patents are similar to “Amphiphilic Polymers as Anti-Infective Agents: 1” above, but further claims facially amphiphilic polymers that are polyphenylene and heteroarylene compounds.
 
 
Facially amphiphilic polymers and oligomers and uses thereof: 1 (1)
 
United States – filed
Patent Cooperation Treaty - filed
National Phase entered
 
Other issued patents: Australia
 
United Stated Divisional – issued 08/07/2012
 
European Divisionals – four filed
 
Other Divisional filings: Australia, China, Japan
 
Category: 1 & 2
Patents expire: 2024
This application claims pharmaceutical compositions and uses for facially amphiphilic polymers, oligomers and small molecules that are polyamides, polyesters, polyurea, polyurethane, polycarbonate, or polyphenylene, compounds.  Uses include method of treatment (systemic and topical) as antimicrobial agents against bacteria, fungi and viruses and as an antidote to heparin and LMWH.  Also, composition of matter claims are expanded.
 
 
 
1
 

Patent
Status
Description
Facially amphiphilic polymers and oligomers and uses thereof: 2   (Phenylalkynes) (1)
United States – filed
Patent Cooperation Treaty - filed
National Phase entered
 
United States patent issued 07/17/2012
 
Other issued patents: Australia
 
United States Divisional – filed
 
European Divisional - filed
 
Other Divisional filings: China, South Korea
 
Category: 1 & 3
Patents expire: 2024
These patents are similar to “Amphiphilic Polymers as Anti-Infective Agents: 1” above, except that the small molecules to which it claims use are polyphenylene and heteroarylene compounds.
 
Polycationic Compounds and Uses thereof
 
United States – filed
 
Patent Cooperation Treaty – filed
 
National Phase entered
 
United States patent issued 06/30/2009
 
European Patent issued 08/07/13
 
Australia Patent issued 05/17/12
 
China Patent Issued 08/22/12
 
South Korea Patent issued 08/03/12
 
United States Continuations –  five filed: four issued 06/29/10; 03/06/12; 07/31/12; 08/13/13; one pending
 
Other Divisional filings: Japan, China
 
South Korea Divisional issued 06/26/12
 
Category: 2
Patents expire: 2025
This application claims method of use for modulating angiogenesis with polycationic compounds, compositions of anti-heparin compounds and methods of inhibiting heparin activity.
 
Composition and Use of Polymethacrylate Co-Polymers (1)
 
United States – filed
Patent Cooperation Treaty - filed
National Phase entered
Australian Patent issued
European Divisionals - three filed
 
Category: 3
Patents expire: 2025
This application claims amphiphilic co-polymers that exhibit antimicrobial activity and uses in a number of pharmaceutical and material applications.
 
 
 
2
 

Patent
Status
Description
Ophthalmic and Otic Compositions of Facially Amphiphilic Polymers and Oligomers and Use Thereof
United States – filed
Patent Cooperation Treaty - filed
National Phase entered
 
Other patents issued: China
 
Other divisional filings: China
 
Category: 1
Patents expire: 2027
This application relates to antimicrobial compositions of facially amphiphilic antimicrobial polymers and oligomers useful for the treatment or prevention of ophthalmic and otic infections.  The application also relates to methods of using the compositions for treating and/or preventing ophthalmic and otic infections.
Combination of Synthetic Antimicrobial Polymers and Sesquiterpenoid Compounds
 
United States – filed
 
Category: 3
Patents expire: 2028
This application relates to the combination of facially amphiphilic antimicrobial polymers and oligomers with sesquiterpenoids to enhance antimicrobial activities.
 
Anti-Malarial  Compounds
United States – filed
Patent Cooperation Treaty - filed
National Phase entered
 
Category: 1
Patents expire: 2029
This application relates in to arylamide and other classes of compounds and their use in treating malaria.
 
Synthetic Mimetics of Host Defense and Uses Thereof
United States – issued 10/02/12
United States Continuation filed
Patent Cooperation Treaty - filed
National Phase entered
 
Category: 1
Patents expire: 2029
This application relates to arylamide compounds, their antimicrobial uses and methods of synthesis.
 
Antimicrobial Molecules for Treating Multi-Drug Resistant and Extensively-Drug Resistant Strains of Mycobacterium
United States - filed
Patent Cooperation Treaty - filed
National Phase entered
 
Category: 1
Patents expire: 2029
This application relates to treating multi-drug resistant and extremely drug resistant strains of mycobacterium with antimicrobial compounds and compositions.
 
Processes for Preparing a Polymeric Compound
 
United States – issued 01/15/13
United States Continuation filed
Mexican Patent issued 06/06/13
Patent Cooperation Treaty – filed
 
Category: 2
Patents expire: 2030
This application relates to preferred methods for synthesizing and preparing pharmaceutical compositions of representative compounds in the salicylamide class of compounds
Anti-Heparin Compounds
 
United States – filed
Patent Cooperation Treaty – filed
National Phase entered
 
Category: 2
Patents expire: 2031
This application relates to methods of antagonizing anticoagulant agents, such as unfractionated heparin, low molecular weight heparin, and/or a derivatives and compositions of the antagonists.
Methods of Immune Modulation
 
United States - filed
Patent Cooperation Treaty – filed
National Phase entered
 
Category: 1
Patents expire: 2031
The present invention is directed, in part, to methods of modulating an immune response in an animal with facially amphiphilic compounds.
 
 
3
 
 
Patent
Status
Description
Facially Amphiphilic Compounds, Compositions, and Uses Thereof
in Treating Cancer
United States - filed
Patent Cooperation Treaty – filed
This entire family was abandoned
 
Category: 1
Patents expire: 2031
The present invention relates to compositions of facially amphiphilic compounds and their use in methods for treating cancers in animals, such as humans.
Compounds For Use in Treatment of Mucositis
United States – filed
Patent Cooperation Treaty – filed
National Phase due 11/13
 
Category: 1
Patents expire: 2032
The application relates to methods of treating and/or preventing mucositis.
Hybrid Compounds and Methods of Making and Using the Same
United States provisional filed
 
Category: 1
The application relates to compositions and use of anti-microbial compounds.
Polycyclic Compounds and Methods of Making and Using the Same
United States provisional filed
 
Category: 1
The application relates to compositions and use of anti-microbial compounds.
Antagonizing Heparin with Salicylamide Compounds and Histamine Blocking Agents
United States provisional filed
 
Category: 2
The application relates to use of anti-heparin salicylamide compounds with histamine blocking agents to treat cardiovascular disorders.
Compounds and Methods for Treating Candidiasis and Aspergillus Infections
United States – filed
Patent Cooperation Treaty – filed
National Phase due 07/14
 
Category: 1
Patents expire: 2033
The application relates to compositions and use of anti-fungal compounds.
Compounds and Methods for Treating Malaria
Patent Cooperation Treaty – filed
National Phase due 08/14
 
Category: 1
Patents expire: 2033
The application relates to compositions and use of anti-malarial compounds.
Compositions of Arylamide Compounds and Antimicrobial Agents
United States provisional filed
Category: 1
The application relates to compositions and use of arylamide compounds and anti-microbial agents.
COMPUTATIONAL PATENTS
Methods, systems and computer program products for computational analysis and design of amphiphilic polymers (1)
United States - issued 09/15/2009
 
Patents expire: 2022
This application is directed to the creation and use of novel force field packages for modeling the structure and behavior of complex molecules in complex environments.  Specific utilities are the prediction of oligomer structures in polar and apolar medias.
Computer simulation of biomembranes using a Coarse Grain Model (1)
 
United States – filed
 
Patents expire: 2022
This application is directed to the creation and use of a novel coarse grain model for studying complex biological structures, such as membranes.  Specifically a computational approach is described that accurately predicts the structural and dynamic properties of membranes that are far less demanding of CPU time than comparable methods.
Computational design of a water-soluble analog of a protein, such as phospholamban and potassium channel Kcsa (1)
United States – filed
 
Patents expire: 2022
This application claims methods and computer programs for the computational design of water-soluble analogs of membrane proteins that retain biological function.
 

 
(1)
Patent rights obtained pursuant to a license agreement with the University of Pennsylvania.

In addition, we have trademark protection for the marks PolyMedix, ®  PolyCide ® , and PolyDentix ® .
 
 
4
 
EXHIBIT 10.38
 
MATERIAL TRANSFER AGREEMENT

This Material Transfer Agreement (“MTA”) has been adopted for use by Cellceutix Corporation, 100 Cummings Center, Suite 151-B, Beverly, MA 01915 (“Cellceutix”) in all transfers of research material (“Research Material”) whether Cellceutix is identified below as its Provider or Recipient.

Provider: Cellceutix Corporation
Provider’s address: 100 Cummings Center, Suite 151-B, Beverly, MA 01915

Recipient: Beth Israel Deaconess
Recipient’s address: 330 Brookline Avenue, Boston, MA 02215

1.  Provider agrees to transfer to Recipient’s Investigator named below the following Research Material:
_____________Kevetrin_____________________________________________

2.   THIS RESEARCH MATERIAL MAY NOT BE USED IN HUMAN SUBJECTS.   This Research Material will only be used for research purposes by Recipient’s investigator in his/her laboratory, for the Research Project described below under suitable containment conditions.  This Research Material will not be used for commercial purposes such as serving, production or sale, for which a commercialization license may be required.  Recipient agrees to comply with all Federal rules and regulations applicable to the Research Project and the handling of the Research Material.

2(a).  Are Research Materials of human origin? _________yes____X____no

2(b).  If yes in 2(a), were Research Materials collected according to 45 CFR 46
“Protection of Human Subject?” __________yes__________no

Please provide Assurance Number: ________________________________________________

3.  This Research Material will be used by Recipient’s investigator solely in connection with the following research project (“Research Project”) described with specificity as follows (use an attachment page if necessary):

See ATTACHED Research Project entitled “Assessment of the Therapeutic Potential of Kevetrin in Melanoma and Renal Cell Carcinoma” at end of document below

4.  Recipient shall obtain written approval on Research Project protocol and procedures from Cellceutix before starting the Research Project. Recipient shall not publish or disclose results of the Research Project without written consent from Cellceutix. Recipient also agrees to include a member of the Cellceutix team as a research collaborator and author in all Research Project publications or publications involving the Research Material named above.
 
 
1
 

5.  This Research Material represents a significant investment on the part of Provider, and is considered proprietary to Provider.  Recipient’s investigator therefore agrees to retain control over this Research Material, and further agrees not to transfer the Research material to other people not under her or his direct supervision without advance written approval of Provider.  Provider reserves the right to distribute the Research Material to others and to use it for its own purposes.  When the Research Project is completed, or three (3) years have elapsed, whichever occurs first, the Research Material will be destroyed by Recipient or otherwise disposed of as mutually agreed by Provider and Recipient. Furthermore, Information regarding the Research Project, apart from publications as mentioned above, will be considered confidential and will be treated as such by Recipient.

6.  This Research Material is BEING SUPPLIED TO RECIPIENT WITH NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE .  Provider makes no representations that the use of the Research Material will not infringe any patent or proprietary rights of third parties.

7.  Cellceutix shall retain title to any patent or other intellectual property rights in inventions made by Recipient’s employees in the course of the Research Project.  Unless prohibited by law from doing so, Recipient agrees to hold Provider harmless and to indemnify Provider for all liabilities, demands, damages, expenses and losses arising out of Recipient’s use for any purpose of the Research Material.

8.  The undersigned Provider and Recipient expressly certify and affirm that the contents of any statements made herein are truthful and accurate.

9.  The validity, interpretation, performance and enforcement of this Agreement shall be governed by the laws of the Commonwealth of Massachusetts, without regard to its choice of law provisions.  The parties hereto hereby irrevocably and unconditionally consent to the exclusive jurisdiction of the courts of the Commonwealth of Massachusetts and the United States District Court for the District of Massachusetts for any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement, and agree not to commence any action, suit or proceeding (other than appeals therefrom) related thereto except in such courts.

IN WITNESS WHEREOF, we, the undersigned as duly authorized representatives, agree to all terms and conditions stated above, and by our signatures, place this Agreement into full effect as of the last date written below.

Beth Israel Deaconess Medical Center                                                                                                 Cellceutix Corporation

 



 
2
 

Assessment of the Therapeutic Potential of Kevetrin in Melanoma and Renal Cell Carcinoma

Rationale : In most melanomas and   renal cell carcinomas (RCC), the gene encoding the tumor suppressor p53 is neither mutated, deleted, nor epigenetically silenced. Because the p53 gene is fundamentally intact in these tumors, it may be possible to exploit the nuclear and/or mitochondrial pro-apoptotic functions of p53 in the treatment of these malignancies.

p53 signaling is virtually always incapacitated in tumor cells. In RCC and melanoma – tumors with an intact p53 gene - the signaling pathways downstream of p53 are presumably disabled by the overexpression of various antagonists that destabilize p53 (e.g. HDM2) or interfere with its transcriptional activity (e.g. iASPP, HDMX). This reliance on p53 antagonists – in particular, HDM2 – as a means of limiting p53 function suggests that these tumors might be susceptible to drugs that block HDM2. Prior work from our lab with an investigational HDM2 antagonist (1), however, has demonstrated that this approach has negligible pro-apoptotic activity in vitro and only modest activity against melanoma and RCC xenografts when the HDM2 antagonist is used as a single agent. Despite the lack of single agent activity, however, the drug was highly lethal against some melanoma cell lines when used in combination with the multikinase inhibitor sorafenib. The pro-apoptotic activity of this drug combination was shown to be dependent on the mitochondrial translocation of p53 and independent of its transcriptional activity. These data suggest that an agent that activates p53 function in the mitochondria (e.g. Kevetrin) might be particularly effective in the treatment of RCC and melanoma.

Proposed Study Design : We propose to assess the effects of Kevetrin alone and in combination with two FDA-approved multikinase (primarily VEGFR2) inhibitors. Prior data from our laboratory indicate that agents of this class can augment the pro-apoptotic and antitumor effects of HDM2 antagonists and will presumably have a similar effect with Kevetrin.

RCC :  Kevetrin will be first evaluated as a single agent for its ability to induce apoptosis in the human RCC cell lines 786-0 and A498 in vitro . These assays will involve exposure of the cells to the drug followed by flow cytometry to assess staining with propidium iodide (PI) and Annexin-FITC. In the event that the drug induces apoptosis as determined by flow cytometry, we will investigate the apoptotic mechanism by examining cell lysates for caspase activation and PARP cleavage. Subcellular fractions of treated cells will be examined for mitochondrial translocation of p53 and nuclear translocation of AIF. We will also determine the extent to which the apoptotic activity of the drug is inhibited by caspase inhibitors (e.g. ZVAD) and agents known to selectively block p53 function in the nucleus (pifithrin- a ) and in the mitochondria (e.g. pifithrin-µ).

To assess the effects of Kevetrin in vivo , the drug will be studied as a single agent and in conjunction with the FDA-approved VEGFR antagonist sunitinib. In these xenograft studies, 1.0 x 10 7 786-0 or A498 human RCC cells will be implanted subcutaneously into the flanks of 40 nude/beige mice.  Once tumors have reached the diameter of 7 mm, the tumor-bearing mice will be divided into 4 treatment groups and treated with Kevetrin alone (200 mg/kg IP MWF ), sunitinib alone (50 mg/kg by gavage), saline (control), or both sunitinib + Kevetrin. Mice will be treated for 21 days.  Tumor size will be measured thrice weekly.  On day #10, three mice from each treatment group will be sacrificed and their tumors excised and divided into two halves. One half will be frozen for subsequent biochemical analysis and the other half fixed in formalin for paraffin embedding. At the end of the study (Day #21 or when the control tumors reach a diameter of 20mm, whichever comes first), the remaining mice will be sacrificed and their tumors excised and processed as described above for the Day #10 tumors. Study endpoints include:

1.
Serial tumor measurements to show the antitumor activity of single agent Kevetrin and that of a Kevetrin/sunitinib combination in RCC xenografts
2.
Analysis of tumor vascularity as determined by IHC (microvessel density with anti-CD31 antibody). It is expected that p53 activation and VEGFR inhibition would act in synergy to suppress tumor angiogenesis.
3.
IHC and western blot analysis to determine the effects of each agent individually and in combination on a). p53 levels and subcellular localization; b). expression of p53-dependent genes such as p21; c). induction of tumor cell apoptosis as determined by caspase 3 activation and TUNEL assay. If increased apoptosis is detected in the tumors from treated mice, we will also assess the ability of the drug(s) to induce AIF nuclear translocation.
 
 
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Melanoma : Kevetrin will be evaluated as a single agent for its ability to induce apoptosis in melanoma cell lines A375, SKMel5 (both of which have the BRAF V600E mutation), SKMel2 (which has an NRAS mutation), and SKMEL31, (which has wild type BRAF and NRAS genes). The methods by which apoptosis will be assessed are identical to those proposed above for the RCC studies.

To determine the activity of Kevetrin against melanoma xenografts, the drug will be studied alone and in combination with the VEGFR antagonist Axitinib. The rationale for this plan is based on our previous work with an HDM2 antagonist which demonstrated limited antitumor activity when used as a single agent but sustained tumor non-progression when used in combination with the multikinase inhibitor sorafenib. The decision to substitute Axitinib for sorafenib is based on its more potent VEGFR inhibitory activity.

For these xenograft studies, 1 x 10 7 A375, SKMel2, and SKMEL31 melanoma cells will be implanted subcutaneously into the flanks of 40 nude/beige mice.  Once tumors have reached the diameter of 7 mm, the tumor-bearing mice will be divided into 4 treatment groups and treated with Kevetrin alone, axitinib alone (30 mg/kg daily) , saline (control), or both Kevetrin + axitinib. Mice are treated daily by gavage for 21 days. Tumor size is measured thrice weekly.  On day #10, three mice from each treatment group will be sacrificed and their tumors excised and divided into two halves. One half will be frozen for subsequent biochemical analysis and the other half fixed in formalin for paraffin embedding. At the end of the study (Day #21 or when the control tumors reach a diameter of 20mm, whichever comes first), the remaining mice will be sacrificed and their tumors excised and processed as described above for the Day #10 tumors. Study endpoints will be the same as those proposed above in the RCC analyses.

Drugs : The sunitinib used in these studies will be unused clinical grade material provided to us by patients who are no longer receiving the drug. The investigational VEGFR2 antagonist axitinib will be purchased from LC Laboratories .
 
References:
1. Liu Q, Mier JW, Panka DJ. Differential modulatory effects of GSK-3 b and HDM2 on sorafenib-induced AIF nuclear translocation (programmed necrosis) in melanoma. Mol Cancer 2011; 10:115.

 
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EXHIBIT 10.39
 
 
 
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