MEI Pharma, Inc. - Quarter Report: 2007 November (Form 10-Q)
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, 2007
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, or a non-accelerated filer. See definition of “accelerated
filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check
one):
Large
accelerated filer o
|
Accelerated
filer o
|
Non-accelerated
filer x
|
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, 2007 the number of shares outstanding of the issuer’s common stock,
$0.00000002 par value, was 68,854,938.
1
MARSHALL
EDWARDS, INC.
INDEX
PART
I
|
FINANCIAL
INFORMATION
|
Page
|
Item
1:
|
Financial
Statements (Unaudited)
|
|
Consolidated
Balance Sheets as of September 30, 2007 and June 30, 2007
|
3
|
|
Consolidated
Statements of Operations for the three months ended September 30,
2007 and
2006 and for the period from December 1, 2000 (inception) through
September 30, 2007
|
4
|
|
Consolidated
Statements of Cash Flows for the three months ended September 30,
2007 and
2006 and for the period from December 1, 2000 (inception) through
September 30, 2007
|
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
|
21
|
Item
3:
|
Quantitative
and Qualitative Disclosures about Market Risk
|
32
|
Item
4:
|
Controls
and Procedures
|
33
|
PART
II
|
OTHER
INFORMATION
|
|
Item
1A
|
Risk
factors
|
34
|
Item
6:
|
Exhibits
|
35
|
SIGNATURES
|
36
|
|
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,
|
|||||||
2007
|
2007
|
|||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
Current
assets
|
||||||||
Cash
and cash equivalents
|
$ |
28,927
|
$ |
16,158
|
||||
Deferred
offering costs
|
-
|
25
|
||||||
Prepaid
expenses and other current assets
|
104
|
107
|
||||||
Total
current assets
|
29,031
|
16,290
|
||||||
Total
assets
|
$ |
29,031
|
$ |
16,290
|
||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
Current
liabilities
|
||||||||
Accounts
payable
|
$ |
1,226
|
$ |
1,197
|
||||
Accrued
expenses
|
1,689
|
984
|
||||||
Amount
due to related company
|
529
|
332
|
||||||
Total
current liabilities
|
3,444
|
2,513
|
||||||
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: 68,854,938 at
|
||||||||
September
30,
2007 and 63,390,937 at June 30, 2007
|
-
|
-
|
||||||
Additional
paid-in capital
|
68,274
|
53,098
|
||||||
Deficit
accumulated during development stage
|
(42,687 | ) | (39,321 | ) | ||||
Total
stockholders' equity
|
25,587
|
13,777
|
||||||
Total
liabilities and stockholders' equity
|
$ |
29,031
|
$ |
16,290
|
||||
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,
|
|||||||||||
2007
|
2006
|
2007
|
||||||||||
Revenues:
|
||||||||||||
Interest
and other income
|
$ |
218
|
$ |
135
|
$ |
1,962
|
||||||
Total
revenues
|
218
|
135
|
1,962
|
|||||||||
Operating
expenses:
|
||||||||||||
Research
and development
|
(2,906 | ) | (927 | ) | (18,847 | ) | ||||||
License
fees
|
-
|
(5,000 | ) | (17,000 | ) | |||||||
Selling,
general and administrative
|
(677 | ) | (2,088 | ) | (8,798 | ) | ||||||
Total
operating expenses
|
(3,583 | ) | (8,015 | ) | (44,645 | ) | ||||||
Loss
from operations
|
(3,365 | ) | (7,880 | ) | (42,683 | ) | ||||||
Income
tax expense
|
(1 | ) |
-
|
(4 | ) | |||||||
Net
loss arising during development stage
|
$ | (3,366 | ) | $ | (7,880 | ) | $ | (42,687 | ) | |||
Net
loss per common share:
|
||||||||||||
Basic
and diluted
|
$ | (0.05 | ) | $ | (0.13 | ) | ||||||
Weighted
average common shares outstanding
|
66,657,459
|
62,619,391
|
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,
|
|||||||||||
2007
|
2006
|
2007
|
||||||||||
Operating
activities
|
||||||||||||
Net
loss arising during development stage
|
$ | (3,366 | ) | $ | (7,880 | ) | $ | (42,687 | ) | |||
Adjustments
to
reconcile net loss to net cash
|
||||||||||||
(used
in) provided by operating activities:
|
||||||||||||
Share
based payments
|
-
|
1,642
|
1,642
|
|||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Prepaid
expenses and other current assets
|
3
|
182
|
(104 | ) | ||||||||
Accounts
payable
|
29
|
(233 | ) |
1,226
|
||||||||
Accrued
expenses
|
705
|
164
|
1,689
|
|||||||||
Amounts
due to related company
|
197
|
3
|
529
|
|||||||||
Net
cash used in operating activities
|
(2,432 | ) | (6,122 | ) | (37,705 | ) | ||||||
Financing
activities
|
||||||||||||
Net
proceeds from issuance of common stock *
|
15,201
|
16,962
|
66,632
|
|||||||||
Net
cash provided by financing activities
|
15,201
|
16,962
|
66,632
|
|||||||||
Net
increase (decrease) in cash and cash
|
||||||||||||
equivalents
|
12,769
|
10,840
|
28,927
|
|||||||||
Cash
and cash equivalents at beginning of period
|
16,158
|
10,054
|
-
|
|||||||||
Cash
and cash equivalents at end of period
|
$ |
28,927
|
$ |
20,894
|
$ |
28,927
|
||||||
Income
taxes paid
|
$ | (1 | ) | $ |
-
|
$ | (4 | ) |
*
Deferred offering costs of $25,000 from the year ended June 30, 2007 have been
offset against net proceeds from the issuance of common stock in the three
months to September 30, 2007.
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, 2007
|
63,390,937
|
$ |
53,098
|
$ | (39,321 | ) | $ |
13,777
|
||||||||
Net
loss arising during development stage
|
(3,366 | ) | (3,366 | ) | ||||||||||||
Comprehensive
Loss
|
(3,366 | ) | ||||||||||||||
Common
Stock issued August 6, 2007
|
5,464,001
|
14,735
|
14,735
|
|||||||||||||
Warrants
issued as share-based payment (refer Note 6)
|
441
|
-
|
$ |
441
|
||||||||||||
Balance
at September 30, 2007
|
68,854,938
|
$ |
68,274
|
$ | (42,687 | ) | $ |
25,587
|
See
accompanying notes to the consolidated financial
statements.
6
MARSHALL
EDWARDS, INC.
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
September
30, 2007
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 is presently engaged in the clinical and pre-clinical
development of the anti-cancer drugs phenoxodiol, 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,
NV-196 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 report
Novogen owns approximately 71.9% 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 have now expanded to include the
additional licensed drug candidates NV-196 and NV-143. During fiscal year 2007,
the Company commenced the OVATURE Phase III clinical trial for phenoxodiol
(known as “OVATURE”) and continued to recruit patients into the existing
clinical trial programs. The Company has reached agreement under the Special
Protocol Assessment (SPA) process with the United States Food and Drug
Administration (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 therapy.
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 and Short Term Investments
Cash
on
hand and in banks and short-term deposits are stated at their 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.
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.
Effective
July 1, 2007 the Company adopted Financial Accounting Standards Interpretation
48 (FIN 48), “Accounting for Uncertainty in Income Taxes – an interpretation of
FASB No 109”. FIN 48 prescribes a recognition threshold and measurement
attribute for the financial statement recognition and measurement of uncertain
tax positions taken or expected to be taken in a company’s income tax return,
and also provides guidance on de-recognition, classification, interest and
penalties, accounting in interim periods, disclosure and transition. FIN 48
utilizes a two step approach for evaluating uncertain tax positions accounted
for in accordance with SFAS No. 109, “Accounting for Income Taxes” (SFAS 109).
Step one, recognition, requires a company to determine if the weight of
available evidence indicates that a tax position is more likely than not to
be
sustained upon audit, including resolution of related appeals or litigation
processes, if any. Step two, measurement, is based on the largest amount of
benefit, which is more likely than not to be realised upon ultimate settlement.
The cumulative effect of adopting FIN 48 on July 1, 2007 is recognised as a
change in accounting principle, recorded as an adjustment to the opening balance
of accumulated deficit on the adoption date. As a result of the implementation
of FIN 48 the Company did not recognise any increase or decrease in the
liability for unrecognised tax benefits related to tax positions taken in prior
periods, therefore, there was no corresponding adjustment in accumulated
deficit. Additionally, FIN 48 specifies that tax positions for which the timing
of the ultimate resolution is uncertain should be recognised as long term
liabilities. The Company's total amount of net tax losses carried forward as
of
July 1, 2007 adoption date was $43 million.
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.
8
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 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, NV-196 and NV-143. Research
and
development costs are charged to expense as 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 are excluded, whereas for diluted
earnings per share they are included unless the effect is anti-dilutive. Since
the Company has a loss for all periods presented, there is no dilutive effect
of
stock options.
9
Comprehensive
Loss
Comprehensive
loss is comprised of net loss and other comprehensive loss. Other comprehensive
loss includes certain changes in stockholders’ equity that are excluded from net
loss. Comprehensive loss for all periods presented has been reflected in
the Consolidated Statement of Stockholders’ Equity.
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.
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,
|
||||
2007
|
2006
|
|||
(In
Thousands, except share and per share data)
|
||||
Numerator
|
||||
Net
loss arising during development stage
|
(3,366)
|
(7,880)
|
||
Effect
of dilutive securities
|
-
|
-
|
||
Numerator
for diluted earnings per share
|
$ |
(3,366)
|
$ (7,880)
|
|
Denominator
|
||||
Denominator
for basic earnings per share:
|
||||
Weighted
average number of shares used in computing net loss per share,
basic and
diluted
|
66,657,459
|
62,619,391
|
||
Effect
of dilutive securities
|
-
|
-
|
||
Dilutive
potential common shares
|
66,657,459
|
62,619,391
|
||
Basic
and diluted earnings per share
|
$ |
(0.05)
|
$ (0.13)
|
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
10
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,
|
||||
2007
|
2006
|
|||
(Number
of warrant shares)
|
||||
Warrants
exercisable prior to December 18, 2006 at an exercise price of
$9.00
|
-
|
2,392,000
|
||
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
|
-
|
||
Warrants
exercisable prior to August 6, 2012 at an exercise price of
$3.00
|
248,364
|
-
|
||
Common
shares issuable upon exercise of outstanding warrants
|
5,249,220
|
5,207,258
|
The
2,392,000 warrants exercisable prior to December 18, 2006 have expired. No
shares of common stock have been issued as a result of exercise of any of these
warrants.
During
July 2006, the Company issued 6,452,937 shares of common stock and 2,815,258
warrants in connection with a PIPE capital raising and to secure a Standby
Equity Distribution Agreement. For further details see Note 6
“Equity”.
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 PIPE
capital raising. For further details see Note 6 “Equity”.
3. Expenditure
Commitments
At
September 30, 2007, the Company had contractual obligations for the conduct
of
clinical trials, pre-clinical research and development and manufacturing process
development of approximately $13,069,000. 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
|
$ |
13,069
|
$ |
8,711
|
$ |
4,172
|
$ |
186
|
$ |
-
|
||||||||||
Total
|
$ |
13,069
|
$ |
8,711
|
$ |
4,172
|
$ |
186
|
$ |
-
|
No amounts have been included for future payments to Novogen which may arise in connection with the license agreements for phenoxodiol, NV-143 and NV-196, the services agreement or the manufacturing license and supply agreement as future payments under the terms of the agreements are subject to termination provisions. Payments in connection with these agreements are detailed in Note 5 “Related Party Transactions”.
The
Company is not currently a party to any material legal proceedings.
11
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.
The
Company has guaranteed the payment and performance of the obligations of its
subsidiary, Marshall Edwards Pty Limited, to Novogen and its subsidiaries,
Novogen Laboratories Pty Limited and Novogen Research Pty Limited, under the
license agreement for phenoxodiol, 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 license agreements
for
phenoxodiol and the obligations of Novogen Laboratories Pty Limited under the
manufacturing license and supply agreement to Marshall Edwards Pty Limited.
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 clinical and pre-clinical program currently
underway for the development and commercialization of phenoxodiol, NV-143 and
NV-196. The business contains two major segments based on geographic
location.
Three
Months Ended September 30, 2007
|
Three
Months Ended September 30, 2006
|
|||||||||||||||
(In
Thousands)
|
||||||||||||||||
USA
|
Australia
|
USA
|
Australia
|
|||||||||||||
Loss
from operations
|
$ | (79 | ) | $ | (3,287 | ) | $ | (1,772 | ) | $ | (6,108 | ) | ||||
Segment
assets
|
22,746
|
6,285
|
15,277
|
5,680
|
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. 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)
12
and
sales
of phenoxodiol products exceeded $50,000,000. Following the PIPE capital raising
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 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.
|
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 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.
13
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 $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 at September 30, 2007.
License
Agreement for NV-196 and NV-143
In
May
2006, the Company entered into a second license agreement with Novogen for
two
oncology compounds, NV-196 and NV-143 (the “License Agreement for NV-196 and
NV-143”). NV-196 is being developed initially in oral form for pancreatic 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 NV-196 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 NV-196 and NV-143 products. The License Agreement for NV-196
and
NV-143 covers uses of NV-196 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 NV-196 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 NV-196 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;
|
14
|
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.
Amended
and Restated License Option Deed
On
September 24, 2003, MEPL and Novogen Resarch 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 NV-196
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 $594,000 and $515,000 were made under
the Services Agreement with Novogen during the three months ended September
30,
2007 and 2006, respectively. Of these amounts, $360,000 and $318,000 related
to
service fees paid to Novogen for research and development services provided
in
the three months ended September 30, 2007 and 2006, respectively, reflecting
the
time spent by Novogen research staff on the development of phenoxodiol, NV-196
and NV-143. Additionally, $234,000 and $197,000 of the total expenditures during
the three months ended September 30, 2007 and
15
2006,
respectively, related to costs incurred for administration and accounting
services provided by Novogen.
At
September 30, 2007 and 2006, $454,000 and $187,000, 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
Under
the
terms of the manufacturing license and supply agreement (the “Manufacturing
License and Supply Agreement”), MEPL has granted to one of Novogen’s
subsidiaries an exclusive, non-transferable sub license to manufacture and
supply phenoxodiol in its primary manufactured form. Novogen’s subsidiary 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.
Transactions
giving rise to expenditures amounting to $12,000 and $50,000 were made under
the
manufacturing license and supply agreement with Novogen during the three months
ended September 30, 2007 and 2006, respectively.
At
September 30, 2007 there was no amount owning to Novogen under the Manufacturing
License and Supply Agreement. At September 30, 2006 $6,000 was due and owing
to
Novogen under the Manufacturing License and Supply Agreement and are included
in
amounts due to parent company.
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 contract facilities that have been identified are
FDA licensed, have a track record of large scale API manufacture and have
already invested in capital and equipment. The Company has completed the
novation to MEPL of contracts that Novogen had entered into with third parties
to develop a scalable manufacturing method 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
MEI
is a
development stage company incorporated in December 2000. MEI commenced
operations in May 2002 coinciding with its listing on the London Stock
Exchange’s Alternative Investment Market (AIM).
In
May
2002, the Company sold 2,523,000 shares of its common stock and 2,523,000
warrants, raising proceeds of $9,022,000, net of $1,070,000 of transaction
costs. The warrants were exercisable prior to November 30, 2003 at an exercise
price of $4.00 per share. The common stock was listed for trading on the
AIM. Following the listing, Novogen retained 95.1% of the Company’s
common stock.
16
In
June
2003, 9,000 warrants were exercised at an exercise price of $4.00 per share,
resulting in proceeds to the Company of $36,000. In November 2003, the remaining
2,514,000 warrants were exercised at an exercise price of $4.00 per share with
proceeds to the Company of $10,056,000.
In
December 2003, the Company sold 2,392,000 common stock units at a public
offering price
of
$7.50 per unit. Each common stock unit consisted of:
·
|
one
share of common stock; and
|
·
|
one
warrant to purchase a share of common stock, exercisable prior to
December
18, 2006 at an exercise price equal to
$9.00.
|
The
2,392,000 warrants exercisable prior to December 18, 2006 have expired. No
shares of common stock have been issued as a result of exercise of any of these
warrants.
In
connection with the December 2003 offering, the Company’s common stock and
warrants commenced trading separately on the Nasdaq Global Market. The Company
received proceeds of $15,522,000, net of $2,431,000 transaction costs in the
December 2003 offering. Following the offering, Novogen retained 86.9% of
the Company’s common stock.
In
January 2006, the Company voluntarily cancelled the trading of its common stock
on the Alternative Investment Market of the London Stock Exchange
(AIM).
On
July
11, 2006, the Company entered into a securities subscription agreement with
certain accredited investors providing for the placement of 6,329,311 shares
of
the Company’s common stock and warrants exercisable for 2,215,258 shares of the
Company’s common stock at a purchase price of $2.90 per unit. Each unit
consisted of one share of common stock and 0.35 of a warrant to purchase one
share of common stock. The warrants have an exercise price of $4.35 per share,
subject to certain adjustments. The exercise price and number of shares issuable
upon exercise of such warrants are subject to adjustment in the event of stock
dividends, stock splits and other similar events. The warrants may be exercised
no less than six months from the closing date and will expire four years from
the date of issuance, or July 11, 2010. The Company closed the private placement
or PIPE on July 11, 2006. In connection with the private placement or PIPE,
the
Company received proceeds of $16.8 million net of $1.5 million commissions
and
other costs.
In
connection with the securities subscription agreement described above the
Company entered into a registration rights agreement pursuant to which the
Company is obligated to file a resale registration statement with the Securities
and Exchange Commission (the “SEC”) covering the shares of common stock issued
in connection with the securities subscription agreement, in addition to the
shares of common stock underlying the warrants issued in connection with the
securities subscription agreement. The Company filed the registration statement
on August 9, 2006. The resale registration statement was declared effective
September 5, 2006.
On
July
11, 2006, the Company entered into a standby equity distribution agreement
(the
“SEDA”), with YA Global Investments, L.P. (“YA Global” formerly Cornell Capital
Partners, L.P.). The SEDA was subsequently terminated in August 2007. Under
the
SEDA, the Company may have issued and sold to YA Global shares of its common
stock for a total purchase price of up to $15 million, once a resale
registration
17
statement
was in effect. Commencing as of the effective date of the registration statement
and continuing for up to 24 months thereafter, the Company had sole discretion
whether and when to sell shares of its common stock to YA Global. YA Global
would have been irrevocably bound to purchase shares of common stock from the
Company after the Company sent a notice that it intended to sell shares of
its
common stock to YA Global. Each advance under the SEDA was limited to a maximum
of $1.5 million.
In
connection with the SEDA, the Company paid YA Global a commitment fee of 123,626
shares of its common stock and warrants to purchase 600,000 shares of its common
stock which expire on July 11, 2010. The warrants have an exercise price of
$4.35 per share, subject to certain adjustments. The exercise price and number
of shares issuable upon exercise of such warrants are subject to adjustment
in
the event of stock dividends, stock splits and other similar events. The
commitment fee, comprising shares and warrants, is a share-based payment
and has been accounted for in accordance with FAS123R "Share-based Payment".
The
fair values of shares and warrants issued have been recognized directly as
equity in the balance sheet and as selling, general and administration expenses
in the income statement in the quarter ended September 30, 2006.
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 on August 6, 2007. In connection with the private placement
or
PIPE we 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 has agreed
to
file a registration statement with 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. The Company filed the registration
statement on October 2, 2007. The resale registration statement was declared
effective October 19, 2007.
Under
the
terms of the July 11, 2006 and the August 1, 2007 PIPEs, the Company is required
to maintain effective registration statements covering the resale shares of
common stock issued in the PIPEs and the shares of common stock issuable upon
exercise of the warrants issued in the PIPEs. In relation to the July 11, 2006
PIPE, at the date of issuance, the Company assessed the terms of the agreement,
and as the penalty for not maintaining the registration of common stock is
less
than the difference between the value of registered shares and unregistered
shares, the equity has been classified as permanent equity. The August 1, 2007
PIPE has been assessed as permanent equity under FASB Staff Position No. EITF
00-19-2, described below.
18
On
January 1, 2007 the Company adopted FASB Staff Position No. EITF 00-19-2 (FSP
00-19-2). FSP 00-19-2 requires the contingent obligation to make future payments
under the registration rights agreements be recognized separately in accordance
with FASB Statement No. 5, Accounting for Contingencies and the underlying
warrants be recognized without regard to the contingent obligation. The adoption
of FSP 00-19-2 had no effect on the Company’s financial statements as the
warrants will remain classified as permanent equity and management does not
currently believe that it is probable a payment will be made under either of
the
registration rights agreements.
Following
the private placement, Novogen retained approximately 71.9% of the
Company’s common stock.
7.
Contingent Liability
On
July
11, 2006 the Company entered into a registration rights agreement in connection
with the private placement or PIPE capital raising which provides for liquidated
damages of up to 10% of the aggregate purchase price of the shares issued as
part of the PIPE transaction if the Company does not maintain an effective
resale registration of those shares. An effective resale registration has been
maintained at the date of this report.
On August
1, 2007 in connection with the private placement of PIPE capital raising, the
Company entered into a registration rights agreement pursuant to which it is
obligated to file a resale registration statement with the SEC by the fifth
calendar day following the filing of the Annual Report on Form 10-K for the
fiscal year ended June 30, 2007. The resale registration statement will cover
the shares of common stock issued in connection with the securities subscription
agreement as well as the shares of common stock underlying the warrants issued
in connection with the securities subscription agreement. The resale
registration statement also covers the shares underlying the warrants issued
to
Blue Trading, LLC, which acted as placement agent in the PIPE as part of its
placement fee. The Company filed the resale registration statement on October
2,
2007. The resale registration statement was declared effective October 19,
2007.
In
the
event that the resale registration statements covering the registrable
securities issued in the July 2006 PIPE and August 2007 PIPE ceases to be
effective or usable at any time while shares of common stock covered by them
remain unsold or may only be sold subject to certain volume limitations, or
investors are not permitted to utilize the prospectus in connection with the
resale registration statements to resell shares of common stock covered by
the
resale registration statements, the Company will be obligated to pay investors
who purchased shares of common stock in the private placement liquidated damages
equal to 1% of the aggregate purchase price paid by each investor pursuant
to
the securities subscription agreement for any shares of common stock, shares
of
common stock issuable upon exercise of warrants or warrants then held by each
investor per month (pro rated for any period less than a month) until the resale
registration statements are effective or the investors are permitted to utilize
the prospectus in connection with the resale registration statements to resell
shares of common stock covered by the resale registration statements. An
effective resale registration statement with respect to the registrable
securities issued in the August 2007 PIPE has been maintained at the date of
this report.
19
Liquidated
damages paid to each investor in the private placements or PIPEs may not exceed
more than 10% of the purchase price paid by such investor for shares of common
stock purchased under the securities subscription agreements.
20
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
limited operating history;
|
· our
inability to obtain any additional required financing or financing
available to us on acceptable terms;
|
· our
failure to successfully commercialize our product candidates;
|
· costs
and delays in the development and/or receipt of 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 development, 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;
|
· 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;
|
21
· 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, 2007. 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
report.
Overview
Our
main
focus since commencing operations is to undertake human clinical testing of
phenoxodiol. Operations have now expanded to include the additional licensed
drug candidates NV-196 and NV-143. During fiscal year 2007, we commenced the
OVATURE Phase III clinical trial for phenoxodiol and continued to recruit
patients into the existing clinical trial programs. We have reached agreement
under the Special Protocol Assessment (SPA) process with the United States
Food
and Drug Administration (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.
As
at the
date of the report Novogen owns approximately 71.9% of the outstanding shares
of
our common stock.
We
do not
employ any staff directly but obtain services from Novogen under a 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 as we expand research and development activities and move phenoxodiol
into later stages of development. As of September 30, 2007, we had accumulated
losses of $42,687,000.
22
We
have
not generated any revenues from operations since inception other than interest
on cash assets.
Expenses
have consisted primarily of costs associated with conducting the clinical trials
of phenoxodiol, costs incurred under the Phenoxodiol License Agreement, costs
incurred under the License Agreement for NV-196 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.
We
expect
that quarterly and annual operating results will fluctuate for the foreseeable
future due to several factors including the timing and extent of research and
development efforts and the outcome and extent of clinical trial activities.
Our
limited operating history makes accurate prediction of future operating results
difficult or impossible.
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, 2007
aggregate to $18,847,000.
Research
and development costs include clinical trial expenses and are expensed as they
are incurred. These costs are expected to increase in the future as the
phenoxodiol clinical program progresses and as we expand our research and
development of NV-196 and NV-143. The planned phenoxodiol Phase III OVATURE
trial will require large patient numbers 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.
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;
|
23
· the
number of treatment cycles patients complete while they are enrolled
in
the trials;
|
· the
indication being studied; 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.
We
intend
to continue the clinical development of phenoxodiol as well as NV-196 and
NV-143, which were licensed from Novogen. We will also continue to assess the
opportunity to license other cancer drugs developed by Novogen as the
opportunities arise.
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 $610,000 have been accrued at September 30, 2007. 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 $810,000 have been accrued at September 30, 2007. These estimates
are based on the milestones completed for each of the service
contracts.
24
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 600,000 warrants issued July 11,
2006, in connection with the SEDA commitment fee and the 62,091 warrants
representing 248,364 warrant shares issued August 6, 2007 to Blue Trading,
LLC
as part of placement fee, the following assumptions were used:
7/11/06
|
8/6/07
|
||
Dividend
yield
|
0%
|
0%
|
|
Expected
volatility
|
76%
|
71%
|
|
Historical
volatility
|
76%
|
71%
|
|
Risk-free
interest rate
|
5.45%
|
4.13%
|
|
Expected
life of warrant
|
4
years
|
5
years
|
|
Warrant
fair value
|
$1.998
|
$1.777
|
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 option 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.
25
Results
of Operations
Three
Months Ended September 30, 2007 and 2006
We
recorded a consolidated loss of $3,366,000 and $7,880,000 for the three months
ended September 30, 2007 and 2006, respectively.
Revenues:
We received interest on cash assets and cash equivalents and short term
investments of $218,000 for the three months ended September 30, 2007 versus
$135,000 for the three months ended September 30, 2006. The increase was due
to
higher cash balances following the capital raising in August 2007 combined
with
an increase in interest rates earned by our cash deposits.
Research
and Development: Research and development expenses increased $1,979,000
to $2,906,000 for the three months ended September 30, 2007 compared to $927,000
for the three months ended September 30, 2006. The increase was due primarily
to
the costs associated with the Phase III OVATURE clinical trial.
License
Fees: No milestone license fees have been expensed in the three months
ended September 30, 2007. Pursuant to the Further Amended and Restated License
Agreement for phenoxodiol, the annual $8,000,000 milestone payment, due to
Novogen on each December 31 during the exclusivity period, will not become
payable until receipt of a New Drug Application (“NDA”) for phenoxodiol or other
approval to market phenoxodiol in the U.S. or abroad has been obtained. The
second lump sum license fee of $5,000,000 due under the terms of the Amended
and
Restated License Agreement was expensed in the three months ended September
30,
2006.
Under
the
terms of the License Agreement for NV-196 and NV-143 the next milestone payment
of $1,000,000 will become due on the date an 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. As neither of these triggers have been met,
no
amount has been expensed in three months ended September 30, 2007 under the
terms of this agreement.
Selling,
General and Administrative: Selling, general and administrative
expenses decreased by $1,411,000 to $677,000 for the three months ended
September 30, 2007 compared to $2,088,000 for the three months ended September
30, 2006. The decrease was primarily due no share based payment expense in the
three months ended September 30, 2007 compared to share based payment expense
of
$1,642,000 in the three months ended September 30, 2006 which represented a
fee
for entering into the SEDA. This decrease in expense was partially offset by
increased investor and public relation costs, increased travel costs and
additional director fees.
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
26
financial
position. At September 30, 2007, we had not established a foreign currency
hedging program. Net foreign exchange losses during the three months ended
September 30, 2007 were $104,000 compared with net foreign exchange gains of
$19,000 during the three months ended September 30, 2006.
Liquidity
and Capital Resources
At
September 30, 2007, we had cash resources of $28,927,000 compared to $16,158,000
at June 30, 2007. The increase was due to the capital raising in
August 2007, 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 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. 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,
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 have 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 October 19, 2007.
In
August
2007, we terminated the standby equity distribution agreement (the “SEDA”) which
we had entered into with YA Global Investments, L.P. (formally Cornell Capital
Partners, L.P.) on July 11, 2006.
Source
and Uses of Cash
Cash
Used in Operating Activities
Cash
used
in operating activities for the three months ended September 30, 2007 was
$2,432,000 compared to $6,122,000 for the same period in 2006. The decrease
in
cash outflow of $3,690,000 was due primarily to no license fees in the three
months ended September 30, 2007 compared to the same period last year which
contained the second lump sum license fee paid to Novogen of $5,000,000,
partially offset by increased cash outflows incurred in connection with the
increased costs associated with the Phase III OVATURE trial.
27
Cash
Requirements
We
are
currently conducting the OVATURE Phase III clinical study to support marketing
approval of phenoxodiol for ovarian cancer and the clinical and pre clinical
development of NV-196 and NV-143.
Ongoing
operations through the conduct of the clinical trial program will continue
to
consume cash resources without generating revenues.
We
believe that the proceeds of the private placement closed in August 2007 provide
us with sufficient cash resources to fund our planned operations over the next
twelve months which include the OVATURE trial, the planned preclinical
development of NV-196 and NV-143 and the planned human Phase I clinical program
for NV-196.
We
will
however need additional funds in order complete the OVATURE trial and to further
the clinical development program for NV-196 and NV-143 beyond the current
objectives.
License
Agreement for Phenoxodiol
In
September 2003, we 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. We 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. 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 exceeds $50,000,000.
Following the PIPE capital raising 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 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.
28
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.
|
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, we 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 for phenoxodiol we were required to pay an $8,000,000 license
milestone fee to Novogen Research Pty Limited in December 2006. The amendment
deed 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 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”), we 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 $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
29
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 at September 30, 2007.
License
Agreement for NV-196 and NV-143
In
May
2006, we entered into a second license agreement with Novogen for two oncology
compounds, NV-196 and NV-143 (the “License Agreement for NV-196 and NV-143”).
NV-196 is being developed initially in oral form for pancreatic 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 NV-196 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
NV-196 and NV-143 products. The License Agreement for NV-196 and NV-143 covers
uses of NV-196 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. We
are required to make payments under the terms of the License Agreement for
NV-196 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. MEPL
must pay to Novogen the following milestone license fees upon the occurrence
of
the corresponding milestone as set forth below:
a) the
first licensed product containing NV-196 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 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;
|
|
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.
|
30
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,
does not exist or is 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.
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.
We
are
currently assessing the future cash requirements needed to fund new clinical
trial initiatives and licensing options available under the license option
deed.
Off-Balance
Sheet Arrangements
We
do not
currently have any off-balance sheet arrangements.
Contractual
Obligations
The
following table summarizes our contractual obligations at September 30,
2007:
(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
|
$ |
13,069
|
$ |
8,711
|
$ |
4,172
|
$ |
186
|
$ |
-
|
||||||||||
Total
|
$ |
13,069
|
$ |
8,711
|
$ |
4,172
|
$ |
186
|
$ |
-
|
No
amounts have been included for future payments to Novogen which may arise in
connection with the Phenoxodiol License Agreement, the License Agreement for
NV-196 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.
31
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 a portion of our business in various currencies, primarily in U.S.
and
Australian dollars. At September 30, 2007, we had not established a foreign
currency hedging program. Net foreign exchange losses during the three months
ended September 30, 2007 were $104,000 compared with net foreign exchange gains
of $19,000 during the three months ended September 30, 2006. 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.
We
do not
consider the effects of foreign currency movements to be a material risk to
our
financial condition.
32
Item
4: Controls
and Procedures
Evaluation
of Disclosure Controls and Procedures
At
the
end of the period covered by this 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).
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 Securities Exchange Act of 1934, as amended
is
recorded, processed, summarized and reported within the time periods specified
in Securities and Exchange Commission 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.
33
PART
II OTHER INFORMATION
Item
1A: Risk
Factors
The
risks
described in Item 1A. Risk Factors, in our Annual Report on Form 10-K for the
year ended June 30, 2007, could materially and adversely effect our business,
financial condition and results of operations. Additional information concerning
those risks and uncertainties and other factors that you may wish to consider
are contained elsewhere in our filings with the Securities and Exchange
Commission.
The
risk
factor titled “If we fail to maintain registration of
the common stock issued
or issuable pursuant to the exercise of warrants we issued in connection with
the securities subscription agreement we entered into with certain investors
effective August 1, 2007, we
may be obligated to pay the investors of those securities liquidated
damages.” in our Annual Report
on Form 10-K for the year ended June 30, 2007, is amended in its entirety to
read as follows:
“If
we fail to maintain registration of the common stock issued or issuable pursuant
to the exercise of warrants we issued in connection with the securities
subscription agreement we entered into with the selling stockholders (other
than
Blue Trading, LLC) effective August 1, 2007, we may be obligated to pay such
selling stockholders liquidated damages.”
In
connection with the securities subscription agreement we entered into with
the
selling stockholders (other than Blue Trading, LLC) as of August 1, 2007, we
entered into a registration rights agreement pursuant to which we are obligated
to file a resale registration statement with the SEC by the fifth calendar
day
following the filing of the our Annual Report on Form 10-K for the fiscal year
ended June 30, 2007, covering the shares of common stock issued in connection
with the securities subscription agreement, in addition to the shares of common
stock underlying the warrants issued in connection with the securities
subscription agreement. We filed the registration statement on
October 2, 2007.
In
the
event that the registration statement covering the registrable securities ceases
to be effective or usable at any time while shares of common stock covered
by it
remain unsold or may only be sold subject to certain volume limitations, or
the
selling stockholders (other than Blue Trading, LLC) are not permitted to utilize
the prospectus in connection with the registration statement to resell shares
of
common stock covered by the registration statement, we will be obligated to
pay
the selling stockholders who purchased shares of common stock in the private
placement liquidated damages equal to 1% of the aggregate purchase price paid
by
each such selling stockholder pursuant to the securities subscription agreement
for any shares of common stock, shares of common stock issuable upon exercise
of
warrants or warrants then held by each such selling stockholder per month (pro
rated for any period less than a month) until the registration statement is
effective or such selling stockholders are permitted to utilize the prospectus
in connection with the registration statement to resell shares of common stock
covered by the registration statement.
Liquidated
damages paid to the selling stockholders (other than Blue Trading, LLC) may
not
exceed more than 10% of the purchase price paid by such selling stockholders
for
shares of common stock purchased under the securities subscription
agreement. If we become obligated to pay liquidated damages, we would
deplete our limited working capital and potentially need to raise additional
funds. Additionally, the payment of liquated damages would negatively
impact our ability to complete future PIPEs.
34
Item
6: Exhibits
and Reports on Form 8-K
a)
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
|
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).
|
35
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant
has
duly caused this Report to be signed on its behalf by the undersigned, thereunto
duly authorized.
MARSHALL
EDWARDS, INC.
/s/
DAVID SEATON
David R. Seaton
Chief Financial Offer
(Duly Authorized Officer and Principal Financial Officer)
Date: November 6, 2007
(Duly Authorized Officer and Principal Financial Officer)
Date: November 6, 2007
36
Exhibit
31.1
CERTIFICATION
I,
Christopher Naughton, certify that:
1.
|
I
have reviewed this report on Form 10-Q of Marshall Edwards,
Inc.;
|
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
registrant as of, and for, the periods presented in this
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) ) 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 those
entities, particularly during the period in which this report is
being
prepared:
|
(b)
|
Evaluated
the effectiveness of the registrant’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
|
(c)
|
Disclosed
in this report any change in the registrant’s internal control over
financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an
annual report) 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(s) 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.
|
/s/CHRISTOPHERNAUGHTON
Christopher
Naughton
Chief Executive Officer
Date: November 6, 2007
37
Exhibit
31.2
CERTIFICATION
I,
David
Ross Seaton, certify that:
1.
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I
have reviewed this report on Form 10-Q of Marshall Edwards,
Inc.;
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2.
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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;
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3.
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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
registrant as of, and for, the periods presented in this
report;
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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) ) for the registrant
and have:
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(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 these
entities, particularly during the period in which this report is
being
prepared:
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(b)
|
Evaluated
the effectiveness of the registrant’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
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(c)
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Disclosed
in this report any change in the registrant’s internal control over
financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably likely
to
materially affect, the Company’s internal control over financial
reporting; and
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5.
|
The
Company’s other certifying officer(s) 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:
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(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
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(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.
|
/s/
DAVID SEATON
David
R. Seaton
Chief
Financial Officer
Date: November 6, 2007
Date: November 6, 2007
38
Exhibit
32
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.
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The
Registrant’s Quarterly Report on Form 10-Q for the period ended September
30, 2007, to which this Certification is attached as Exhibit 32 (the
“Periodic Report”), fully complies with the requirements of Section 13(a)
or Section 15(d) of the Securities Exchange Act of 1934, as amended;
and
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2.
|
The
information contained in the Periodic Report fairly presents, in
all
material respects, the financial condition of the Registrant at the
end of
the period covered by the Periodic Report and results of operations
of the
registrant for the period covered by the Periodic
Report.
|
These
certifications accompany 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 6, 2007
/s/
CHRISTOPHER
NAUGHTON
Christopher
Naughton
Chief
Executive
Officer
/s/
DAVID SEATON
David R. Seaton
Chief Financial Officer
39