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MEI Pharma, Inc. 10-Q 2008

Documents found in this filing:

  1. 10-Q
  2. 10-Q
form10q20081106.htm


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q

[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2008

OR

[   ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ________ to ________.

Commission File Number: 000-50484

Marshall Edwards, Inc.
(Exact name of registrant as specified in its charter)

DELAWARE
51-0407811
(State or other jurisdiction of
(I.R.S. Employer Identification No.)
incorporation or organization)
 

140 Wicks Road, North Ryde, NSW, 2113 Australia
(Address of principal executive offices) (Zip Code)

(011) 61 2 8877- 6196
Registrant’s telephone number, including area code:


Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes  x No  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 definition of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
 
Large accelerated filer             o
Non-accelerated filer                      x
Accelerated filer                o
Smaller reporting entity           o

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

 
As of October 31, 2008 the number of shares outstanding of the issuer’s common stock, $0.00000002 par value, was 73,463,233.

 


 
1
MARSHALL EDWARDS, INC.

INDEX
PART I
FINANCIAL INFORMATION
Page
     
Item 1:
Financial Statements (Unaudited)
 
 
Consolidated Balance Sheets as of September 30, 2008 and June 30, 2008
3
 
Consolidated Statements of Operations for the three months ended  September 30, 2008 and 2007 and for the period from December 1, 2000 (inception) through  September 30, 2008
4
 
Consolidated Statements of Cash Flows for the three months ended  September 30, 2008 and 2007 and for the period from December 1, 2000 (inception) through  September 30, 2008
5
 
Consolidated Statement of Stockholders’ Equity
6
 
Notes to Consolidated Financial Statements
7
     
Item 2:
Management’s Discussion and Analysis of Financial Condition and Results of Operation
18
     
Item 3:
Quantitative and Qualitative Disclosures about Market Risk
27
     
Item 4T:
Controls and Procedures
28
     
     
PART II
OTHER INFORMATION
 
     
Item 1A:
Risk Factors
29
     
Item 6:
Exhibits
30
     
     
SIGNATURES
31
     

 
2
PART I  FINANCIAL INFORMATION
Item 1: Financial Statements

MARSHALL EDWARDS, INC.
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)

             
   
September 30
   
June 30,
 
   
2008
   
2008
 
   
(unaudited)
       
             
ASSETS
 
Current assets
           
    Cash and cash equivalents
  $ 26,941     $ 19,743  
    Deferred offering costs
    -       110  
    Prepaid expenses and other current assets
    79       125  
        Total current assets
    27,020       19,978  
        Total assets
  $ 27,020     $ 19,978  
                 
LIABILITIES AND STOCKHOLDERS' EQUITY
 
Current liabilities
               
    Accounts payable
  $ 713     $ 1,130  
    Accrued expenses
    1,904       1,884  
    Amount due to related company
    241       429  
        Total current liabilities
    2,858       3,443  
                 
Stockholders' equity:
               
Preferred stock, $0.01 par value, authorized 100,000 shares,
         
    none outstanding
    -       -  
Common stock, $ 0.00000002 par value, 113,000,000 authorized
         
    shares; shares issued and outstanding: 73,463,233 at
         
    September 30, 2008 and 68,854,938 at June 30, 2008
    -       -  
Additional paid-in capital
    78,145       68,266  
Deficit accumulated during development stage
    (53,983 )     (51,731 )
Total stockholders' equity
    24,162       16,535  
Total liabilities and stockholders' equity
  $ 27,020     $ 19,978  


See accompanying notes to the consolidated financial statements.

3
MARSHALL EDWARDS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
(Unaudited)
   
Three Months Ended
September 30,
   
Period from December 1, 2000 (Inception) through 
September 30,
 
   
2008
   
2007
   
2008
 
                   
Revenues:
                 
    Interest and other income
  $ 96     $ 218     $ 2,514  
        Total revenues
    96       218       2,514  
                         
Operating expenses:
                       
    Research and development
    (2,078 )     (2,906 )     (27,344 )
    License fees
    -       -       (18,000 )
    Selling, general and administrative
    (269 )     (677 )     (11,146 )
        Total operating expenses
    (2,347 )     (3,583 )     (56,490 )
                         
Loss from operations
    (2,251 )     (3,365 )     (53,976 )
Income tax expense
    (1 )     (1 )     (7 )
Net loss arising during development stage
  $ (2,252 )   $ (3,366 )   $ (53,983 )
                         
Net loss per common share:
                       
    Basic and diluted
  $ (0.03 )   $ (0.05 )        
                         
Weighted average number of common shares outstanding
    71,910,438       66,657,459          

 

See accompanying notes to the consolidated financial statements.

 
4
MARSHALL EDWARDS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)


   
Three Months Ended 
September 30,
   
Period from December 1, 2000 (Inception) through 
September 30,
 
   
2008
   
2007
   
2008
 
                   
Operating activities
                 
Net loss arising during development stage
  $ (2,252 )   $ (3,366 )   $ (53,983 )
Adjustments to reconcile net loss to net cash
                       
    (used in) provided by operating activities:
                       
Share based payments
    65       -       1,707  
Changes in operating assets and liabilities:
                       
    Prepaid expenses and other current assets
    46       3       (79 )
    Accounts payable
    (417 )     29       713  
    Accrued expenses
    20       705       1,904  
    Amounts due to related company
    (188 )     197       241  
Net cash used in operating activities
    (2,726 )     (2,432 )     (49,497 )
                         
Financing activities
                       
Net proceeds from issuance of  common stock *
    9,924       15,201       76,438  
Net cash provided by financing activities
    9,924       15,201       76,438  
Net increase (decrease) in cash and cash
                       
    equivalents
    7,198       12,769       26,941  
Cash and cash equivalents at beginning of period
    19,743       16,158       -  
Cash and cash equivalents at end of period
  $ 26,941     $ 28,927     $ 26,941  
 
 
* Deferred offering costs of $110,000 from the year ended June 30, 2008 have been offset against net proceeds from the issuance of common stock in the three months to September 30, 2008.







See accompanying notes to the consolidated financial statements.

5
MARSHALL EDWARDS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
(In thousands, except share data)
(Unaudited)

   
Common Stock
   
Additional paid in capital
   
Deficit accumulated during development stage
   
Total
 
   
(shares)
                   
                         
Balance at June 30, 2008
    68,854,938     $ 68,266     $ (51,731 )   $ 16,535  
Net loss arising during development stage
    -       -       (2,252 )     (2,252 )
    Comprehensive Loss
                            (2,252 )
Common Stock issued July 31, 2008
    4,608,295       9,814       -       9,814  
                                 
Warrants issued as share-based payment (refer Note 6)
    -       65       -       65  
                                 
Balance at September 30, 2008
    73,463,233     $ 78,145     $ (53,983 )   $ 24,162  





See accompanying notes to the consolidated financial statements.
 
6
MARSHALL EDWARDS, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
 (Unaudited)


1.      The Company and Summary of Significant Accounting Policies

Marshall Edwards, Inc. (“MEI”) including its subsidiary Marshall Edwards Pty Ltd (“MEPL”) (together the “Group or the “Company”) is a development stage company incorporated in December 2000 as a wholly-owned subsidiary of Novogen Limited (“Novogen”). The Company commenced operations in May 2002 and its business purpose is the development and commercialization of drugs for the treatment of cancer. The Company has been engaged in the clinical and pre-clinical development of the anti-cancer drugs phenoxodiol, triphendiol (formally NV-196) and NV-143. Novogen’s subsidiary has granted to MEPL, worldwide non-transferable licenses under its patent right and patent applications and its relevant know-how to conduct clinical trials and commercialize and distribute all forms of phenoxodiol, triphendiol and NV-143 for uses in the field of prevention, treatment, and cure of cancer in humans, except topical applications. As at the date of this Quarterly Report, Novogen owns approximately 71.3% of the outstanding shares of the Company’s common stock.

The Company’s main focus since commencing operations has been to undertake human clinical testing of phenoxodiol. Operations were expanded to include the additional licensed drug candidates triphendiol and NV-143. During fiscal year 2007, the Company commenced the OVATURE Phase III clinical trial for phenoxodiol (known as “OVATURE”). The Company has reached agreement under the Special Protocol Assessment process with the United States Food and Drug Administration (the “FDA”) on the design of its OVATURE pivotal study protocol for phenoxodiol. The trial is designed to test the ability of phenoxodiol to restore sensitivity of late-stage ovarian cancers to carboplatin, a standard form of therapy for ovarian cancer. During fiscal year 2008 and quarter one of fiscal year 2009, the Company has continued to recruit patients into the OVATURE trial. Due to the global financial crisis the Company has decided to preserve cash and progress the development of triphendiol to an IND and put on hold the development of NV-143, focusing its resources on OVATURE.


Principles of Consolidation

The consolidated financial statements include the accounts of MEI and its wholly-owned subsidiary, MEPL. Significant intercompany accounts and transactions have been eliminated on consolidation.

Estimates

The preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying notes. Actual results could differ from those estimates.

7
Revenue Recognition

Interest

The only revenue earned to date is interest on cash balances, which is recognized on an accruals basis.

Cash and Cash Equivalents

Cash on hand and in banks and short-term deposits is stated at its nominal value. The Company considers all highly liquid investments, with a maturity of three months or less when purchased, to be cash equivalents. Highly liquid investments with stated maturities of greater than three months are classified as short-term investments. The Company’s cash, held in the United States, is deposited in financial institutions that are FDIC insured. These deposits are in excess of the FDIC insurance limits. The Company also holds cash with Australian financial institutions. Cash held in Australia has Government backing up to $A1 million per account.

Income Taxes

Income taxes have been provided for using the liability method in accordance with FASB Statement No. 109, “Accounting for Income Taxes.” Under this method, deferred tax assets and liabilities are recognized and measured using enacted tax rates in effect for the year in which the differences are expected to be recognized. Valuation allowances are established against the recorded deferred income tax assets to the extent that management believes that it is more likely than not that a portion of the deferred income tax assets are not realizable. There is a full valuation allowance against net operating losses.

The Company adopted Financial Accounting Standards Interpretation No. 48, “Accounting for Uncertainty in Income Taxes – an interpretation of FASB No 109” (“FIN 48”) effective July 1, 2007. The implementation of FIN 48 did not result in any increase or decrease in the liability for unrecognized tax benefits related to tax positions taken in prior periods, therefore there was no corresponding adjustment in accumulated deficit. The Company’s total amount of unrecognized tax benefits as of June 30, 2008 was $64 million. This consists of net operating losses carried forward for which recognition is more likely than not.

The Company’s major tax jurisdictions are the United States and Australia and its tax years since inception remain subject to examination by the appropriate governmental agencies in those jurisdictions due to its tax loss position.

Fair Value of Financial Instruments

The carrying amounts of the Company’s financial instruments, including cash and cash equivalents and accounts payable, approximate fair value.

Foreign Currency Translation

The financial statements of MEPL have been translated into U.S. dollars in accordance with
 
8
FASB Statement No. 52, “Foreign Currency Translation.” Assets and liabilities are translated into U.S. dollars using the exchange rates in effect at the balance sheet date. Income statement amounts have been translated using the average exchange rate for the periods. Realized gains and losses from foreign currency transactions are reflected in the consolidated statements of operations.

Translation of MEPL’s financial statements into U.S. dollars does not have a material impact on the Company’s financial position.

Research and Development Expenses

Research and development expenses relate primarily to the cost of conducting human clinical and pre-clinical trials of phenoxodiol, triphendiol and NV-143. Research and development costs are charged to earnings in the period incurred.

License Fees

Costs incurred related to the acquisition or licensing of products that have not yet received regulatory approval to be marketed, or that are not commercially viable and ready for use or have no alternative future use, are charged to earnings in the period incurred.

Stock-Based Compensation

The Company’s stock option plan provides for the grant of options to the Company’s directors, employees, employees of the Company’s affiliates and certain of the Company’s contractors and consultants. To date, no options have been issued under the plan.

Other stock-based payments have been accounted for in accordance with SFAS No. 123R “Share-Based Payments”. The Company therefore recognizes the cost of goods acquired or the expense for services received in a share-based payment transaction when it obtains the goods or as services are received. The Company recognizes a corresponding increase in equity or a liability depending on the classification of the share-based instrument granted.

Basic and Diluted Loss Per Share

Basic and diluted earnings or loss per share is calculated in accordance with FASB Statement No. 128, “Earnings Per Share.” In computing basic earnings or loss per share, the dilutive effect of stock options and warrants are excluded, whereas for diluted earnings per share they are included unless the effect is anti-dilutive.

Stockholders’ Equity

Ordinary share capital is recognized at the fair value of the consideration received by the Company. Any transaction costs arising on the issue of shares are recognized directly in equity as a reduction in the share proceeds received.

9
Deferred Offering Costs

Where costs associated with a capital raising have been incurred at balance date and it is probable that the capital raising will be successfully completed after balance date, such costs are deferred and offset against the proceeds subsequently received from the capital raising.

2.           Loss Per Share

The following table sets forth the computation of basic and diluted net loss per common share:

     
Three Months Ended September 30,
     
2008
2007
     
(In Thousands, except share and per share data)
Numerator
       
Net loss arising during development stage
   
            (2,252)
            (3,366)
Effect of dilutive securities
   
                   -
                   -
Numerator for diluted earnings per share
  $
(2,252)
 $         (3,366)
         
Denominator
       
Denominator for basic earnings per share:
       
Weighted average number of shares used in computing net loss per share, basic and diluted
     71,910,438
     66,657,459
Effect of dilutive securities
   
                   -
                   -
Dilutive potential common shares
   
     71,910,438
     66,657,459
         
Basic and diluted earnings per share
  $
(0.03)
 $           (0.05)
 
 
During the period presented, the Company had warrants outstanding that could potentially dilute basic earnings per share in the future, but were excluded from the computation of diluted net loss per share as the effect would have been anti-dilutive. Since the Company has a loss for all periods presented, diluted and basic earnings per share are the same. The outstanding warrants consist of the following potential common shares:

   
As at September 30,
 
   
2008
   
2007
 
   
(Number of warrant shares)
 
Warrants exercisable prior to July 11, 2010 at an exercise price of $4.35
    2,815,258       2,815,258  
Warrants exercisable prior to August 6, 2012 at an exercise price of $3.60
    2,185,598       2,185,598  
Warrants exercisable prior to August 6, 2012 at an exercise price of $3.00
    248,364       248,364  
Warrants exercisable prior to July 30, 2013 at an exercise price of $2.17
    46,083       -  
Common shares issuable upon exercise of outstanding warrants
    5,295,303       5,249,220  
 
 
During August 2007, the Company issued 5,464,001 shares of common stock and warrants exercisable for 2,433,962 shares of common stock in connection with a private placement or PIPE capital raising. For further details see Note 6 “Equity”.

During July 2008, the Company issued 4,608,295 shares of common stock and warrants exercisable for 46,083 shares of common stock. For further details see Note 6 “Equity”.


10
3.      Expenditure Commitments>

At September 30, 2008, the Company had contractual obligations for the conduct of clinical trials, pre-clinical research and development and manufacturing process development of approximately $16,192,000. Of the expenditure commitments, clinical trial amounts are based on the assumption that all patients enrolled in clinical trials will complete the maximum number of allowed treatment cycles. The amounts, assuming all treatment cycles are completed, are expected to be incurred as follows:

                               
(In thousands)
       
Payment due by period
Contractual Obligations
 
Total
   
less than 1 Year
   
1 - 3 Years
   
3 - 5 Years
   
More than 5 Years
 
                               
Purchase Obligations
  $ 16,192     $ 9,450     $ 5,640     $ 1,102     $ -  
                                         
Total
  $ 16,192     $ 9,450     $ 5,640     $ 1,102     $ -  
 
No amounts have been included for future payments to Novogen which may arise in connection with the Phenoxodiol License Agreement, the License Agreement for Triphendiol and NV-143, the Services Agreement or the Manufacturing License and Supply Agreement, as future payments under the terms of the agreements are subject to termination provisions. The terms of the agreements, including future payments, are detailed in Note 5 “Related Party Transactions.”

The Company is not currently a party to any material legal proceedings.

The Company’s certificate of incorporation provides that it will indemnify Novogen in connection with certain actions brought against Novogen by any of the Company’s stockholders or any other person.

Pursuant to the terms of a Guarantee and Indemnity Agreement, the Company has guaranteed the payment and performance of the obligations of MEPL to Novogen and its subsidiaries, Novogen Laboratories Pty Limited and Novogen Research Pty Limited, under the Phenoxodiol License Agreement, the Manufacturing License and Supply Agreement and the Services Agreement. Novogen has guaranteed the performance of the obligations of Novogen Research Pty Limited under the Phenoxodiol License Agreement and the obligations of Novogen Laboratories Pty Limited under the Manufacturing License and Supply Agreement to MEPL. Each of the Company and Novogen’s obligations in the Guarantee and Indemnity Agreement are absolute, unconditional and irrevocable.


4.
Segment Information

The Company’s focus is to continue the OVATURE clinical trial program currently underway for the development and commercialization of phenoxodiol. The business contains two major operating segments based on geographic location.

11
 
 
   
Three Months Ended September 30, 2008
   
Three Months Ended September 30, 2007
 
   
(In Thousands)
 
   
USA
   
Australia
   
USA
   
Australia
 
Loss from operations
  $ (253 )   $ (1,999 )   $ (79 )   $ (3,287 )
Segment assets
    20,854       6,166       22,746       6,285  
 

5.           Related Party Transactions

License Agreement for Phenoxodiol

In September 2003, the Company entered into a license agreement pursuant to which Novogen’s subsidiary, Novogen Research Pty Limited, granted to MEPL a worldwide non-transferable license under its patents and patent applications and in its know-how to conduct clinical trials and commercialize and distribute phenoxodiol products (the “Phenoxodiol License Agreement”). The Phenoxodiol License Agreement covers uses of phenoxodiol in the field of prevention, treatment or cure of cancer in humans delivered in all forms except topical applications. The license is exclusive until the expiration or lapsing of the last relevant Novogen patents or patent applications in the world and thereafter is non-exclusive. MEPL may terminate the Phenoxodiol License Agreement by giving three months notice to Novogen. MEPL paid $5,000,000 to Novogen in February 2004 which was the first lump sum license fee payment due under the terms of the Phenoxodiol License Agreement. Also, MEPL paid $2,000,000 to Novogen in January 2005 and $4,000,000 in January 2006 which were the annual milestone license fee payments due under the Phenoxodiol License Agreement. The Company paid a second lump sum license fee of $5,000,000 to Novogen in July 2006 following the raising of funds in a private placement or PIPE. This license fee was due on the later of November 1, 2003 or such later date when the cumulative total of all funds received from debt or equity issuances and revenue received from commercialization (income other than sales) and sales of phenoxodiol products exceeded $50,000,000. Following the PIPE capital raising which closed on July 11, 2006, the funds received from equity issuances exceeded $50,000,000 which triggered this license fee payment. Future amounts payable to Novogen under terms of the Phenoxodiol License Agreement are as follows:

1. Until the expiration of the exclusivity period of the license, MEPL must pay Novogen 2.5% of all net sales and 25% of commercialization income. After the exclusivity period of the license, 1.5% of net sales must be paid to Novogen. The preconditions to such payments have not yet occurred.

The “Exclusivity Period” ends on the later of:

(a)
the date of expiration or lapsing of the last patent right in the patents and patent applications set out in the Phenoxodiol License Agreement with Novogen; or

(b)
the date of expiration or lapsing of the last licensed patent right which MEPL would, but for the license granted in the Phenoxodiol License Agreement, infringe in any country in the geographical territory covered by the Phenoxodiol License Agreement by doing in that country any of the things set out in the Phenoxodiol License Agreement.

12
2. In addition to the amounts above, beginning in 2006, an $8,000,000 annual milestone license fee is payable under the amended terms of the Phenoxodiol License Agreement for each calendar year ending December 31 during the exclusivity period of the license. The annual milestone license fees have been deferred under the License Amendment Deed for Phenoxodiol and the Further Amended and Restated License Agreement which are discussed below.

License Amendment Deed for Phenoxodiol

In June 2006, the Company entered into an amendment deed to the Phenoxodiol License Agreement (the “License Amendment Deed for Phenoxodiol”). Pursuant to the original term of the Phenoxodiol License Agreement, the Company was required to pay an $8,000,000 license milestone fee to Novogen Research Pty Limited in December 2006. The License Amendment Deed for Phenoxodiol extends the date that the $8,000,000 license milestone fee is payable until the earliest receipt by MEPL of the first:

(i)
approval by the FDA of a New Drug Application (“NDA”) for phenoxodiol;
(ii)
approval or authorization of any kind to market phenoxodiol in the United States; or
(iii)
approval or authorization of any kind by a government agency in any other country to market phenoxodiol.

Upon receipt of any of the above (the “Approval Date”), the Company must pay to Novogen, $8,000,000, together with interest on that amount from (and including) December 31, 2006, calculated at the bank bill rate. This milestone replaces the $8,000,000 December 31, 2006 milestone fee.

Further Amended and Restated License Agreement

Following agreement in March 2007, MEPL and Novogen Research Pty Limited entered into another amendment deed to the Phenoxodiol License Agreement for the purpose of further amending and restating the Phenoxodiol License Agreement (the “Further Amended and Restated License Agreement”).

The combined result of the License Amendment Deed for Phenoxodiol and the Further Amended and Restated License Agreement will be that upon the Approval Date, MEPL will be required to pay Novogen Research Pty Limited $8,000,000, together with interest on such amount from (and including) December 31, 2006 to (but excluding) the Approval Date. Thereafter, MEPL will be required to make license milestone fee payments of $8,000,000 to Novogen Research Pty Limited on December 31 of the year of the Approval Date and on December 31 of each year thereafter during the exclusivity period under the Phenoxodiol License Agreement.

No license fees have been accrued in respect of phenoxodiol at September 30, 2008.

License Agreement for Triphendiol and NV-143

In May 2006, the Company entered into a second license agreement with Novogen for two oncology compounds, triphendiol and NV-143 (the “License Agreement for Triphendiol and NV-143”). Triphendiol is being developed initially in oral form for the treatment of pancreatic
 
13
and bile duct cancer and is currently in Phase I human testing. NV-143 is targeted for the treatment of melanoma, also in oral dose form, and is in the pre-clinical testing stage. The License Agreement for Triphendiol and NV-143 is an agreement under which Novogen’s subsidiary, Novogen Research Pty Limited, grants to MEPL a worldwide non-transferable license under its patents and patent applications and in its know-how to conduct clinical trials and commercialize and distribute triphendiol and NV-143 products. The License Agreement for Triphendiol and NV-143 covers uses of triphendiol and NV-143 in the field of prevention, treatment or cure of cancer in humans delivered in all forms except topical applications. The license is exclusive until the expiration or lapsing of the last relevant Novogen patents or patent applications in the world and thereafter is non-exclusive. MEPL may terminate the agreement by giving three months notice to Novogen. The Company is required to make payments under the terms of the License Agreement for Triphendiol and NV-143 with Novogen as follows:

1.           A lump sum license fee of $1,000,000 is payable to Novogen on the commencement date of the license in consideration of the license granted. This initial lump sum license fee was paid to Novogen in May 2006.

2.           In further consideration of the license granted, MEPL must pay to Novogen the following milestone license fees upon the occurrence of the corresponding milestone as set forth below;

a)           the first license product containing triphendiol to reach a milestone as set forth below; and
b)           the first licensed product containing NV-143 to reach a milestone as set forth below.
 
  The milestone license fees are:
 
i)
$1,000,000 on the date an investigational new drug application (“IND”) for the licensed product goes into effect or the equivalent approval of a government agency is obtained in another country. If this event does not occur before March 31, 2008 then this amount will be due on this date. The amount of $1,000,000 was paid to Novogen on March 31, 2008 under the terms of this agreement;
 
ii)
$2,000,000 on the date of enrollment of the first clinical trial subject in a Phase II clinical trial of the licensed product. If this event does not occur before June 30, 2009, then this amount will be due on this date;
 
iii)
$3,000,000 on the date of enrollment of the first clinical trial subject in a Phase III clinical trial of the licensed product. If this event does not occur before December 31, 2011, then this amount will be due on this date; and
 
iv)
$8,000,000 on the date of first receipt of a NDA for the licensed product from the FDA or equivalent approval from a government agency in another country. If this event does not occur before December 31, 2013, then this amount will be due on this date.

3.           MEPL must pay Novogen royalties of 5.0% of all net sales and 25% of commercialization income for the term of the license. The royalty rate is reduced by 50% if the licensed patent rights in any country or territory expire, lapse, are revoked, do not exist or are assigned to MEPL and the product is entirely manufactured and supplied in such country.

4.           Minimum royalties of $3,000,000 per year are payable following the date of first receipt of an NDA for a licensed product from the FDA (or equivalent approval from a government agency in any other country) until the expiration of the term.
 
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No license fees have been accrued in respect of triphendiol or NV-143 at September 30, 2008.


Amended and Restated License Option Deed

On September 24, 2003, MEPL and Novogen Research Pty Limited entered into an Amended and Restated License Option Deed (the “License Option Deed”). The License Option deed grants MEPL an exclusive right to accept and an exclusive right to match any proposed dealing by Novogen of its intellectual property rights with a third party relating to synthetic compounds (other than phenoxodiol) that have known or potential applications in the field of prevention, treatment or cure of cancer in humans in all forms other than topical applications.

Amended and Restated Services Agreement

On September 24, 2003, the Company, Novogen and MEPL entered into an Amended and Restated Services Agreement (the “Services Agreement”). The Company does not currently intend to directly employ any staff. Under the terms of the Services Agreement, Novogen or its subsidiaries have agreed to provide services reasonably required by the Company relating to the development and commercialization of phenoxodiol and other licensed products, including triphendiol and NV-143. Novogen has agreed to provide these services at cost plus a 10% mark-up. The Company may terminate the agreement on three months written notice to Novogen.

Transactions giving rise to expenditures amounting to $683,000 and $594,000 were made under the Services Agreement with Novogen during the three months ended September 30, 2008 and 2007, respectively. Of these amounts, $442,000 and $360,000 related to service fees paid to Novogen for research and development services provided in the three months ended September 30, 2008 and 2007, respectively, reflecting the time spent by Novogen research staff on the development of phenoxodiol, triphendiol and NV-143. Additionally, $241,000 and $234,000 of the total expenditures during the three months ended September 30, 2008 and 2007, respectively, related to costs incurred for administration and accounting services provided by Novogen.

At September 30, 2008 and 2007, $241,000 and $454,000, respectively, were due and owing to Novogen under the services agreement and are included in amounts due to related company in the balance sheet.

Manufacturing License and Supply Agreement

On September 24, 2003, MEPL and Novogen Laboratories Pty Limited, a subsidiary of Novogen, entered into an amended and restated manufacturing license and supply agreement (the “Manufacturing License and Supply Agreement”). Under the terms of the Manufacturing License and Supply Agreement, MEPL has granted to Novogen Laboratories Pty Limited an exclusive, non-transferable sub license to manufacture and supply phenoxodiol in its primary manufactured form. Novogen Laboratories Pty Limited has agreed to supply phenoxodiol to MEPL for the clinical trial development program and phenoxodiol’s ultimate commercial use. Phenoxodiol supplied by Novogen under the terms of this agreement will be charged at cost plus a 50% markup.

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There were no transactions under the Manufacturing License and Supply Agreement with Novogen during the three months ended September 30, 2008. Transactions giving rise to expenditures amounting to $12,000 were made under the Manufacturing License and Supply Agreement with Novogen during the three months ended September 30, 2007.

At September 30, 2008 and 2007 there was no amounts owning to Novogen under the Manufacturing License and Supply Agreement.

Novogen has taken the strategic decision not to manufacture large scale Active Pharmaceutical Ingredients (“API”) for cancer drugs, including phenoxodiol, as these can be more economically supplied by third parties with particular expertise in this area. The Company has entered into contracts with third parties to ensure that sufficient quantities of phenoxodiol can be manufactured in compliance with cGMP (Current Good Manufacturing Practices), to supply the necessary quantities of API for the OVATURE trial and to complete the analytical and stability work necessary for an NDA submission.


6. Equity

On August 1, 2007, the Company entered into a securities subscription agreement with certain accredited investors providing for the placement of 5,464,001 shares of its common stock at a purchase price of $3.00 per share. The investors in the transaction also received a warrant to purchase an additional 4 shares of common stock for every block of 10 shares of common stock purchased. All of the warrants have an exercise price of $3.60 per share. The warrants may be exercised beginning February 6, 2008 and will expire five years from the date of issuance, or August 6, 2012. The Company also issued 62,091 warrants to Blue Trading, LLC, which acted as the placement agent in the private placement, as part of the placement fee. The warrants issued to Blue Trading, LLC have an exercise price of $3.00 per share and each warrant is convertible for 4 shares of common stock. These warrants may be exercised immediately and will expire five years from the date of issuance, on August 6, 2012. The Company closed the private placement, or PIPE, on August 6, 2007. In connection with the PIPE, the Company received proceeds of $15.2 million net of $1.2 million in commissions and other costs.

The Company entered into a registration rights agreement with the investors party to the securities subscription agreement and Blue Trading, LLC, and agreed to file a resale registration statement with the SEC registering the common stock and the common stock issuable upon exercise of the warrants sold pursuant to the securities subscription agreement for resale thereunder. The Company filed the registration statement on October 2, 2007. The resale registration statement was declared effective October 19, 2007.

Following the closing of the PIPE in August 2007, Novogen retained approximately 71.9% of the Company’s common stock.

The Company filed a shelf registration statement on Form S-3 (File No. 333-149807) (The “Shelf Registration Statement”) with the SEC in March 2008. The Shelf Registration Statement was declared effective by the SEC on April 3, 2008. The Shelf Registration Statement permits the Company to sell, from time to time, up to $75,000,000 of common stock, preferred stock and warrants or any combination of the foregoing. Pursuant to SEC
 
16
regulations, however, the Company cannot sell securities from the Shelf Registration Statement which represent more than one third of the Company’s public float during any 12-month period.

The Company entered into a Securities Subscription Agreement dated as of July 28, 2008 with Novogen and OppenheimerFunds, Inc. (“Oppenheimer”) pursuant to which the Company sold 2,908,295 and 1,700,000 shares of common stock to Novogen and Oppenheimer, respectively, with Oppenheimer acting as adviser to each of the following parties severally and not jointly: (i) Oppenheimer International Growth Fund; (ii) Mass Mutual International Equity Fund; (iii) Oppenheimer International Growth Fund/VA; (iv) AZL Oppenheimer International Growth Fund; (v) OFITC International Growth Fund; and (vi) OFI International Equity Fund, at a purchase price of $2.17 per share, the consolidated closing bid price of the Company’s Common Stock as quoted by the Nasdaq Market Intelligence Desk at 4:00 PM EST on July 28, 2008.  The shares were registered under the Securities Act of 1933, as amended (the “Securities Act”), under the Shelf Registration Statement. The Company received gross proceeds of $10 million from the sale of the shares.

Following the closing of the registered direct offering described above in July 2008, Novogen retained approximately 71.3% of the Company’s common stock.

In July 2008, the Company also issued a warrant to Mr. John O’Connor exercisable for 46,083 shares of common stock, as consideration for investor relations services rendered by him to the Company. The warrant has an exercise price of $2.17 per share. The warrant may be exercised immediately and expires five years from the date of issuance, on July 30, 2013. The warrant has not been registered under the Securities Act. The Company issued the warrant to Mr. O’Connor in a private placement made in reliance upon the exemption from securities registration afforded by Section 4(2) of the Securities Act.

7. Contingent Liabilities

Under the terms of the license agreements with Novogen, milestone license fee payments are payable upon achieving certain milestones. Details of the payments due under these agreements are detailed in Note 5 “Related Party Transactions.” The license agreements are subject to termination provisions.
 
 
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Item 2: Management’s Discussion and Analysis of Financial Condition and Results of Operation

Special Note Regarding Forward-Looking Statements
 
This Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this quarterly report, including statements regarding the future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” and similar expressions, as they relate to the Company, are intended to identify forward-looking statements. We have based these forward-looking statements largely on current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things:
· our inability to obtain additional required financing or financing available to us on acceptable terms, particularly in the context of the current global financial crisis;
 
· our inability to maintain or enter into, and our dependence upon, collaboration or contractual arrangements necessary for the clinical development of phenoxodiol and other drug candidates;
 
· our limited operating history;
 
· our failure to successfully commercialize our product candidates;
 
· costs and delays in the development and/or receipt of the approval of the U.S. Food and Drug Administration (the “FDA”) or other required governmental approvals, or the failure to obtain such approvals, for our product candidates;
 
· uncertainties in clinical trial results;
 
· our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the manufacture, commercialization, marketing, sales and distribution of any products;
 
· our inability to control the costs of manufacturing our products;
 
· continued cooperation and support of Novogen Limited (“Novogen”), our parent company;
 
· competition and competitive factors;
 
· our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business;
 
· our inability to operate our business without infringing the patents and proprietary rights of others;
 
 
 
18
 
· costs stemming from our defence against third party intellectual property infringement claims;
 
· difficulties in enforcement of civil liabilities against those of our officers and directors who are residents of jurisdictions outside the United States;
 
· general economic conditions;
 
· the failure of any products to gain market acceptance;
 
· technological changes;
 
· government regulation generally and the receipt of the regulatory approvals;
 
· changes in industry practice; and
 
· one-time events.
 
These risks are not exhaustive. Other sections of this quarterly report may include additional factors which could adversely impact business and financial performance. In addition, our business and financial performance may be affected by the factors that are discussed under “Risk Factors” in the Annual Report on Form 10-K for the year ended June 30, 2008. Moreover, we operate in a very competitive and rapidly changing environment.
 
You should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or will occur. 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.
 
The following discussion is qualified in its entirety by, and should be read in conjunction with, the more detailed information set forth in the financial statements and the notes thereto appearing elsewhere in this Quarterly Report.
 
Overview

Our main focus since commencing operations is to undertake human clinical testing of phenoxodiol. Our operations were expanded to include the additional licensed drug candidates triphendiol and NV-143. During fiscal year 2007, we commenced the Phase III clinical trial (known as “OVATURE”). We have reached agreement under the Special Protocol Assessment process with the FDA on the design of our OVATURE pivotal study protocol for phenoxodiol. The trial is designed to test the ability of phenoxodiol to restore sensitivity of late-stage ovarian cancers to carboplatin, a standard form of therapy for ovarian cancer. During fiscal year 2008 and quarter one of fiscal year 2009, the Company has continued to recruit patients into the OVATURE trial.

As at the date of the Quarterly Report, Novogen owns approximately 71.3% of the outstanding shares of our common stock.

We believe that the proceeds from the registered direct offering closed in July 2008 provides us with sufficient cash resources to fund operations over the next twelve months which include progressing the Phase III OVATURE trial.

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Due to the current financial crisis and the uncertainties surrounding our ability to raise funds from the equity markets in the short to medium term, we are progressing the development of triphendiol to an IND and we have put on hold the development of NV-143. This will enable us to conserve cash and focus our resources on conducting the OVATURE trial. We will however need additional funds in order complete the OVATURE trial and to progress the clinical development program for triphendiol and NV-143 beyond the current objectives.

As of September 30, 2008, we had accumulated losses of $53,983,000.

We have not generated any revenues from operations since inception other than interest on cash assets.

We do not employ any staff directly but obtain services from Novogen under the Services Agreement. We have incurred losses since inception and expect to incur operating losses and generate negative cash flows from operations for the foreseeable future.

Expenses to date have consisted primarily of costs associated with conducting the clinical trials of phenoxodiol including OVATURE, costs incurred under the Phenoxodiol License Agreement, the License Agreement for Triphendiol and NV-143, the Services Agreement and the Manufacturing License and Supply Agreements with Novogen and its subsidiaries, including the costs of the clinical trial drug supplies.

To date, operations have been funded primarily through the sale of equity securities.

Critical Accounting Estimates

The preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying notes. Actual results could differ from those estimates.

Development Expenses

Research and development costs incurred since inception through September 30, 2008 aggregate to $27,344,000.

Research and development costs include clinical trial expenses and are expensed as they are incurred. Costs are expected to increase in the future as the number of treated patients in the OVATURE trial increases resulting in significantly increased costs.

Historical research and development costs and clinical trial costs have not been documented on a project by project basis. In addition, research and development resources are supplied by Novogen across several projects. As a result, the costs incurred for each clinical project cannot be stated precisely on a project by project basis.

We expect that a large percentage of research and development expenses in the future will be incurred in support of current and future clinical development programs. These expenditures are subject to a number of uncertainties in timing and cost to completion.

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The duration and cost of clinical trials may vary significantly over the life of a project as a result of:
· the number of sites included in the trials;
· the length of time required to enroll suitable patients;
· the number of patients that participate in the trials;
· the number of treatment cycles patients complete while they are enrolled in the    trials;
· the indication being studied;
· the availability of alternative treatment; and
· the efficacy and safety profile of the product.

Our strategy also includes the option of entering into collaborative arrangements with third parties to participate in the development and commercialization of our drug candidates. In the event third parties have control over the clinical development process, the completion date would largely be under the control of that third party.

As a result of these uncertainties, we are unable to determine the duration of, or completion costs for, research and development projects or when, and to what extent, we will receive cash inflows from the commercialization and sale of the drug candidates.

Clinical Trial Expenses

Estimates have been used in determining the expense liability under certain clinical trial contracts where services have been performed but not yet invoiced. The actual costs of those services could differ in amount and timing from the estimates used in completing the financial results.

Clinical trial expenses of $1,558,000 have been accrued at September 30, 2008. These estimates are based on the number of patients in each trial and the number of drug administration cycles completed.

Clinical research contracts may vary depending on the clinical trial design and protocol. Generally the costs, and therefore estimates, associated with clinical trial contracts are based on the number of patients, drug administration cycles, the type of treatment and the outcome being measured. The length of time before actual amounts can be determined will vary depending on length of the patient cycles and the timing of the invoices by the clinical trial partners.

Manufacturing Scale-up Expenses

Estimates have been used in determining the expense liability under certain manufacturing scale-up contracts where services have been performed but not yet invoiced. The actual costs of those services could differ in amount and timing from the estimates used in completing the financial results.

Manufacturing expenses of $21,000 have been accrued at September 30, 2008. These estimates are based on the milestones completed for each of the service contracts.

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Stock Based Compensation

We account for stock based payments in accordance with SFAS No. 123R “Share-Based Payments”. The costs of these equity-settled transactions are determined using a binomial model to calculate the fair value at the date on which they are granted. With respect to the fair value of the 62,091 warrants representing 248,364 warrant shares issued August 6, 2007 to Blue Trading, LLC as part of a placement fee, and the warrant representing 46,083 warrant shares issued to Mr J.O’Connor July 30, 2008, in consideration for investor relations services rendered, the following assumptions were used:
 

 
August 6, 2007
July 30, 2008
Dividend yield
0%        
0%
Expected volatility
71%        
81%
Historical volatility
71%        
81%
Risk-free interest rate
4.13%        
3.36%
Expected life of warrant
5 years        
5 years
Warrant fair value
$1.777        
$1.41

The dividend yield reflects the assumption that the current dividend payout, which is zero, will continue with no anticipated increases. The expected life of the warrant is based on historical data and is not necessarily indicative of exercise patterns that may occur. The expected volatility reflects the assumption that the historical volatility is indicative of future trends, which may also not necessarily be the actual outcome.

The Company’s stock option plan provides for the grant of options to the Company’s directors, employees, employees of the Company’s affiliates and certain of the Company’s contractors and consultants. To date, no options have been issued under the plan.

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Results of Operations

Three Months Ended September 30, 2008 and 2007

We recorded a consolidated loss of $2,252,000 and $3,366,000 for the three months ended September 30, 2008 and 2007, respectively.




Foreign exchange gains/(losses) are included in selling, general and administrative expenses and occur when revaluing cash denominated in foreign currencies and upon consolidation of our wholly owned subsidiary Marshall Edwards Pty Ltd (“MEPL”). MEPL uses U.S. dollars as its functional currency and also engages in transactions in foreign currencies. Further, MEPL’s accounts and financial statements are denominated in Australian dollars. Translation of MEPL’s financial statements into U.S. dollars did not have a material impact on our financial position however exchange rates are volatile in the current market resulting from the global financial crisis. At September 30, 2008, we had not established a foreign currency hedging program. Net foreign exchange gains during the three months ended September 30, 2008 were $408,000 compared with foreign exchange losses of $104,000 during the three months ended September 30, 2007.

Liquidity and Capital Resources

At September 30, 2008, we had cash resources of $26,941,000 compared to $19,743,000 at June 30, 2008. The increase was due to the registered direct offering in July 2008, as described below, which was partially offset by expenditures in the clinical trial program and other corporate expenses incurred in the period. Funds are invested in short term money market accounts, pending use.

On August 1, 2007, we entered into a securities subscription agreement with certain accredited investors providing for the placement of 5,464,001 shares of our common stock at a purchase price of $3.00 per share. The investors in the transaction also received a warrant to purchase an additional 4 shares of common stock for every block of 10 shares of common stock purchased. All of the warrants have an exercise price of $3.60 per share.
 
23
The warrants may be exercised beginning February 6, 2008 and will expire five years from the date of issuance, or August 6, 2012. We also issued 62,091 warrants to Blue Trading, LLC, which acted as the placement agent in the private placement or PIPE, as part of the placement fee. The warrants issued to Blue Trading, LLC have an exercise price of $3.00 per share and each warrant is convertible for 4 shares of common stock. These warrants may be exercised immediately and will expire five years from the date of issuance, on August 6, 2012. We closed the private placement on August 6, 2007 and we received proceeds of $15.2 million net of $1.2 million commissions and other costs.

We have entered into a registration rights agreement with the investors party to the securities subscription agreement and Blue Trading, LLC, and agreed to file a registration statement with the Securities and Exchange Commission (the “SEC”) for the common stock and the common stock issuable upon exercise of the warrants sold pursuant to the securities subscription agreement for resale thereunder. We filed the registration statement on October 2, 2007. The resale registration statement was declared effective on October 19, 2007.

In connection with our preparation to raise additional funds, we filed a shelf registration statement on Form S-3 (File No. 333-149807)(the “Shelf Registration Statement”) with the SEC in March 2008. The Shelf Registration Statement was declared effective by the SEC on April 3, 2008. The Shelf Registration Statement permits us to sell, from time to time, up to $75,000,000 of common stock, preferred stock and warrants or any combination of the foregoing. Pursuant to SEC regulations, however, we cannot sell securities from the Shelf Registration Statement which represent more than one third of our public float during any 12-month period.

On July 28, 2008 we entered into a Securities Subscription Agreement with Novogen and OppenheimerFunds, Inc. (“Oppenheimer”) pursuant to which we sold 2,908,295 and 1,700,000 shares of common stock to Novogen and Oppenheimer, respectively, with Oppenheimer acting as adviser to each of the following parties severally and not jointly: (i) Oppenheimer International Growth Fund; (ii) Mass Mutual International Equity Fund; (iii) Oppenheimer International Growth Fund/VA; (iv) AZL Oppenheimer International Growth Fund; (v) OFITC International Growth Fund; and (vi) OFI International Equity Fund, at a purchase price of $2.17 per share, the consolidated closing bid price of our Common Stock as quoted by the Nasdaq Market Intelligence Desk at 4:00 PM EST on July 28, 2008.  The shares were registered under the Securities Act of 1933, as amended (the “Securities Act”) under the Shelf Registration Statement. We received gross proceeds of $10 million from the sale of the shares.

Following the closing of the registered direct offering described above in July 2008, Novogen retained approximately 71.3% of the our common stock.

In July 2008, we also issued a warrant to Mr. John O’Connor exercisable for 46,083 shares of common stock, as consideration for investor relation services rendered by him to us. The warrant has an exercise price of $2.17 per share. The warrant may be exercised immediately and expires five years from the date of issuance, on July 30, 2013. The warrant has not been registered under the Securities Act. We issued the warrant to Mr. O’Connor in a private placement made in reliance upon the exemption from securities registration afforded by Section 4(2) of the Securities Act.


24
Source and Uses of Cash

Cash Used in Operating Activities

Cash used in operating activities for the three months ended September 30, 2008 was $2,726,000 compared to $2,432,000 for the same period in 2007. The increase in cash outflow of $294,000 was due primarily to increased cash outflows incurred in connection with the increased costs associated with the Phase III OVATURE trial.

Cash Requirements

We are currently conducting the OVATURE Phase III clinical study to support marketing approval of phenoxodiol for ovarian cancer.

Ongoing operations through the conduct of the clinical trial program will continue to consume cash resources without generating revenues.

We believe that the proceeds from the registered direct offering closed in July 2008 provides us with sufficient cash resources to fund operations over the next twelve months which include progressing the Phase III OVATURE trial.

Due to the uncertainty in the financial markets, we do not anticipate being able to raise additional funds through the equity markets in the short to medium term as a result we are progressing the development of triphendiol to an IND and we have put on hold the development of NV-143. This will enable us to conserve cash and focus our resources on conducting the OVATURE trial. We will however need additional funds in order complete the OVATURE trial and to progress the clinical development program for triphendiol and NV-143 beyond the current objectives. In order to obtain the additional funding necessary to conduct our business, we may need to rely on collaboration and /or licensing opportunities.  We cannot assure you that we will be able to raise the funds necessary to complete the OVATURE trial or find appropriate collaboration or licensing opportunities.

Payments to Novogen

Future payments to Novogen under the terms of the Phenoxodiol License Agreement, the License Amendment Deed for Phenoxodiol, the Further Amended and Restated License Agreement and the License Agreement for Triphendiol and NV-143 are detailed in Note 5 of the financial statements “Related Party Transactions” on page 12 of this Quarterly Report

We will also be required to make payments to Novogen under the Services Agreement and Manufacturing License and Supply Agreement.

We do not intend to incur any significant capital expenditures in the foreseeable future.


Off-Balance Sheet Arrangements

We do not currently have any off-balance sheet arrangements.

25
Contractual Obligations

For details of our contractual obligations at September 30, 2008 see Note 3 to the financial statements “Expenditure Commitments on page 11 of this Quarterly Report.
 
 
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Item 3: Quantitative and Qualitative Disclosures about Market Risk

 
Interest Rate Risk

We place cash in “on call” deposits and short term investments with high quality financial institutions.

We do not consider the effects of interest rate movements to be a material risk to our financial condition. We do not use derivative financial instruments to hedge our risks associated with the fluctuations of interest rates.

Foreign Currency Risk

We conduct our business in various currencies, primarily in U.S. and Australian dollars. At September 30, 2008, we had not established a foreign currency hedging program. Net foreign exchange gains during the three months ended September 30, 2008 were $408,000 compared with net foreign exchange losses of $104,000 during the three months ended September 30, 2007. Foreign exchange gains and losses occur upon consolidation of MEPL, which uses U.S. dollars as its functional currency and also engages in transactions in foreign currencies. MEPL’s accounts are denominated in Australian dollars. Translation of MEPL’s financial statements into U.S. dollars did not have a material impact on our financial position however exchange rates are volatile in the current market resulting from the global financial crisis.

We do not consider the effects of foreign currency movements to be a material risk to our financial condition.


27
Item 4T: Controls and Procedures
 
Evaluation of Disclosure Controls and Procedures

At the end of the period covered by this Quarterly Report, our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)). Based on this evaluation, our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures are effective to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms.
 
There were no changes in our internal control over financial reporting during the period covered by this Form 10-Q that have materially affected, or are reasonably likely to affect, the Company’s internal control over financial reporting.


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PART II  OTHER INFORMATION

Item 1A: Risk Factors

Set forth below in this Quarterly Report on Form 10-Q and in other documents we file with the Securities and Exchange Commission, including, without limitation, our most recently filed Annual Report on Form 10-K, are risks and uncertainties that could cause actual results to differ materially from the results contemplated by the forward-looking statements in this Quarterly Report on Form 10-Q. We believe that these risks and uncertainties are the principal material risks facing the Company as of the date of this Quarterly Report on Form 10-Q. In the future, we may become subject to additional risks that are not currently known to us. If any of these risks actually occur, our business, financial condition and operating results could be seriously harmed. As a result, the trading price of our common stock could decline, and you could lose all or part of the value of your investment.

We may not be able to complete our OVATURE clinical trial if we believe that the trial does not demonstrate efficacy, or if we encounter serious safety issues or if we do not complete patient recruitment  in a timely manner.

The OVATURE clinical trial may be terminated by us following the review of recommendations by the Independent Data Monitoring Committee for many reasons including, but not limited to, if:

·  
patients experience an unacceptable rate or severity of adverse side effects;

·  
patient numbers are not available to enrol at the expected rate or trial sites are unable to recruit their target patient numbers due to the strict inclusion criteria of the OVATURE protocol which may reduce the patient pool available to participate in the trial; or

·  
we are unable to negotiate with the FDA additional patient recruitment time in order to achieve our targeted patient recruitment numbers.



The recent global financial crisis may negatively impact our liquidity and clinical trials, including the OVATURE trial, by precluding us from raising funds through equity investments on terms favorable to us or at all.

We have traditionally raised capital through the sale of equity securities to investors.  Recently the financial services industry and credit markets have experienced a period of unprecedented turmoil characterized by bankruptcy, failure and collapse or sale of various financial institutions. Although the ultimate outcome of these events cannot be predicted, they may preclude us from raising the capital necessary to finance our business operations, including our clinical trials such as the OVATURE trial, through the sale of equity securities on terms favorable to us or at all. In order to obtain the additional funding necessary to conduct our business, we may need to rely on collaboration and /or licensing opportunities.  We cannot assure you that we will be able to raise the funds necessary to complete the OVATURE trial or find appropriate collaboration or licensing opportunities.



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Item 6: Exhibits


Exhibit Index

Exhibits

31.1
Certification required by Rule 13a-14(a) or Rule 15d-14(a)
31.2
Certification required by Rule 13a-14(a) or Rule 15d-14(a)
32.1
Certification required by Rule 13a-14(b) or Rule 15d-14(b) and section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C 1350).







30
SIGNATURES



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

MARSHALL EDWARDS, INC.

/s/ DAVID SEATON

David R. SeatonChief Financial Offer
(Duly Authorized Officer and Principal Financial Officer)

Date: November 4, 2008

31
Exhibit 31.1
CERTIFICATION

I, Christopher Naughton, certify that:

 
1.  
I have reviewed this Quarterly Report on Form 10-Q of Marshall Edwards, Inc.;
 
2.  
Based on my knowledge, this Quarterly 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 Quarterly Report;
 
3.  
Based on my knowledge, the financial statements, and other financial information included in this Quarterly Report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this Quarterly Report;
 
4.  
The registrant’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 registrant 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 registrant, including its consolidated subsidiaries, is made known to us by others within the entities, particularly during the period in which this Quarterly 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 registrant’s disclosure controls and procedures and presented in the Quarterly Report our conclusions about the effectiveness of this disclosure controls and procedures, as of the end of the period covered by this Quarterly Report based on such evaluation; and
 
(d)  
Disclosed in this Quarterly Report any change in the registrant’s internal control over financial reporting that occurred during the registrants first fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
 
5.  
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors:
 
(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 registrant’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 registrant’s internal control over financial reporting.


Date: November 4, 2008                                                                                    
 
 
 /s/CHRISTOPHER NAUGHTON

Christopher Naughton
Chief Executive Officer

32
Exhibit 31.2
CERTIFICATION

I, David Ross Seaton, certify that:

 
1.  
I have reviewed this Quarterly Report on Form 10-Q of Marshall Edwards, Inc.;
 
2.  
Based on my knowledge, this Quarterly 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 Quarterly Report;
 
3.  
Based on my knowledge, the financial statements, and other financial information included in this Quarterly Report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this Quarterly Report;
 
4.  
The registrant’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 registrant 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 registrant, including its consolidated subsidiaries, is made known to us by others within the entities, particularly during the period in which this Quarterly 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 registrant’s disclosure controls and procedures and presented in the Quarterly Report our conclusions about the effectiveness of this disclosure controls and procedures, as of the end of the period covered by this Quarterly Report based on such evaluation; and
 
(d)  
Disclosed in this Quarterly Report any change in the registrant’s internal control over financial reporting that occurred during the registrants first fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
 
5.  
The Company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors:
 
(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 registrant’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 registrant’s internal control over financial reporting.


Date: November 4, 2008                                                                                     
 
 
/s/ DAVID SEATON

David R. Seaton
Chief Financial Officer

33
Exhibit 32.1

CERTIFICATION


Pursuant to the requirement set forth in Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934, as amended, and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. § 1350), Christopher Naughton, the President and Chief Executive Officer of Marshall Edwards, Inc. (the “Registrant”), and David R. Seaton, the Chief Financial Officer of the Registrant, each hereby certifies that, to his or her knowledge:

1.  
The Registrant’s Quarterly Report on Form 10-Q for the period ended September 30, 2008, to which this Certification is attached as Exhibit 32.1 “Form 10-Q”, fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended; and
2.  
The information contained in the “Form 10-Q” fairly presents, in all material respects, the financial condition of the Registrant at the end of the period covered by the Form 10-Q and results of operations of the registrant for the period covered by the Form 10-Q.

These certifications accompanying the Form 10-Q to which they relate, are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of the registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.

Dated: November 4, 2008






/s/ CHRISTOPHER NAUGHTON                                                                                               

Christopher Naughton                                                                                     
Chief Executive Officer                                                                                                
 
 
/s/ DAVID SEATON
 

David R. Seaton
Chief Financial Officer
 
34
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