MEI Pharma, Inc. - Quarter Report: 2009 May (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 March 31, 2009
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 has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files).
Yes o 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
April 30, 2009 the number of shares outstanding of the issuer’s common stock,
$0.00000002 par value, was 73,463,233.
MARSHALL
EDWARDS, INC.
INDEX
PART
I
|
FINANCIAL
INFORMATION
|
Page
|
Item
1:
|
Financial
Statements (Unaudited)
|
|
Consolidated
Balance Sheets as of March 31, 2009 and June 30, 2008
|
3
|
|
Consolidated
Statements of Operations for the three months and nine months ended March
31, 2009 and 2008 and for the period from December 1, 2000 (inception)
through March 31, 2009
|
4
|
|
Consolidated
Statements of Cash Flows for the nine months ended March 31, 2009 and 2008
and for the period from December 1, 2000 (inception) through March 31,
2009
|
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
|
17
|
Item
3:
|
Quantitative
and Qualitative Disclosures about Market Risk
|
29
|
Item
4T:
|
Controls
and Procedures
|
30
|
PART
II
|
OTHER
INFORMATION
|
|
Item
1A:
|
Risk
Factors
|
31
|
Item
6:
|
Exhibits
|
32
|
SIGNATURES
|
33
|
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)
March
31,
|
June
30,
|
|||||||
2009
|
2008
|
|||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
Current
assets
|
||||||||
Cash
and cash equivalents
|
$ | 23,152 | $ | 19,743 | ||||
Deferred
offering costs
|
- | 110 | ||||||
Prepaid
expenses and other current assets
|
154 | 125 | ||||||
Total
current assets
|
23,306 | 19,978 | ||||||
Total
assets
|
$ | 23,306 | $ | 19,978 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
Current
liabilities
|
||||||||
Accounts
payable
|
$ | 1,112 | $ | 1,130 | ||||
Accrued
expenses
|
1,362 | 1,884 | ||||||
Amount
due to related company
|
194 | 429 | ||||||
Total
current liabilities
|
2,668 | 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
|
||||||||
March
31, 2009 and 68,854,938 at June 30, 2008
|
- | - | ||||||
Additional
paid-in capital
|
78,124 | 68,266 | ||||||
Deficit
accumulated during development stage
|
(57,486 | ) | (51,731 | ) | ||||
Total
stockholders' equity
|
20,638 | 16,535 | ||||||
Total
liabilities and stockholders' equity
|
$ | 23,306 | $ | 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
March
31,
|
Nine
Months Ended
March
31,
|
Period
from December 1, 2000 (Inception) through
March
31,
|
||||||||||||||||||
2009
|
2008
|
2009
|
2008
|
2009
|
||||||||||||||||
Revenues:
|
||||||||||||||||||||
Interest and
other income
|
$ | 29 | $ | 149 | $ | 201 | $ | 582 | $ | 2,619 | ||||||||||
Total
revenues
|
29 | 149 | 201 | 582 | 2,619 | |||||||||||||||
Operating
expenses:
|
||||||||||||||||||||
Research and
development
|
(1,545 | ) | (1,860 | ) | (4,988 | ) | (6,631 | ) | (30,254 | ) | ||||||||||
License
fees
|
- | (1,000 | ) | - | (1,000 | ) | (18,000 | ) | ||||||||||||
Selling,
general and administrative
|
(388 | ) | (620 | ) | (967 | ) | (1,957 | ) | (11,844 | ) | ||||||||||
Total
operating expenses
|
(1,933 | ) | (3,480 | ) | (5,955 | ) | (9,588 | ) | (60,098 | ) | ||||||||||
Loss
from operations
|
(1,904 | ) | (3,331 | ) | (5,754 | ) | (9,006 | ) | (57,479 | ) | ||||||||||
Income
tax expense
|
- | (1 | ) | (1 | ) | (3 | ) | (7 | ) | |||||||||||
Net
loss arising during development stage
|
$ | (1,904 | ) | $ | (3,332 | ) | $ | (5,755 | ) | $ | (9,009 | ) | $ | (57,486 | ) | |||||
Net
loss per common share:
|
||||||||||||||||||||
Basic
and diluted
|
$ | (0.03 | ) | $ | (0.05 | ) | $ | (0.08 | ) | $ | (0.13 | ) | ||||||||
Weighted
average number of common shares outstanding
|
73,463,233 | 68,854,938 | 72,941,857 | 68,119,782 |
See
accompanying notes to the consolidated financial statements.
4
MARSHALL
EDWARDS, INC.
(A
Development Stage Company)
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(In
thousands)
(Unaudited)
Nine
Months Ended
March
31,
|
Period
from December 1, 2000 (Inception) through
March
31,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Operating
activities
|
||||||||||||
Net
loss arising during development stage
|
$ | (5,755 | ) | $ | (9,009 | ) | $ | (57,486 | ) | |||
Adjustments to
reconcile net loss to net cash
|
||||||||||||
(used
in) provided by operating activities:
|
||||||||||||
Share
based payments
|
90 | - | 1,732 | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Prepaid
expenses and other current assets
|
(29 | ) | (137 | ) | (154 | ) | ||||||
Accounts
payable
|
(18 | ) | (131 | ) | 1,112 | |||||||
Accrued
expenses
|
(522 | ) | 568 | 1,362 | ||||||||
Amounts
due to related company
|
(235 | ) | 312 | 194 | ||||||||
Net
cash used in operating activities
|
(6,469 | ) | (8,397 | ) | (53,240 | ) | ||||||
Financing
activities
|
||||||||||||
Net
proceeds from issuance of common stock *
|
9,878 | 15,141 | 76,392 | |||||||||
Net
cash provided by financing activities
|
9,878 | 15,141 | 76,392 | |||||||||
Net
increase in cash and cash equivalents
|
3,409 | 6,744 | 23,152 | |||||||||
Cash
and cash equivalents at beginning of period
|
19,743 | 16,158 | - | |||||||||
Cash
and cash equivalents at end of period
|
$ | 23,152 | $ | 22,902 | $ | 23,152 |
*
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 nine months
to March 31, 2009.
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
|
- | - | (5,755 | ) | (5,755 | ) | ||||||||||
Comprehensive
Loss
|
(5,755 | ) | ||||||||||||||
Common
Stock issued July 31, 2008
|
4,608,295 | 9,768 | - | 9,768 | ||||||||||||
Warrants
issued as share-based payment (refer Note 6)
|
- | 90 | - | 90 | ||||||||||||
Balance
at March 31, 2009
|
73,463,233 | $ | 78,124 | $ | (57,486 | ) | $ | 20,638 |
See
accompanying notes to the consolidated financial statements.
6
MARSHALL
EDWARDS, INC.
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Basis
of Presentation and Summary of Significant Accounting Policies
Marshall
Edwards, Inc. (“MEI”) including its wholly-owned 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”). As of the date of this Quarterly Report, Novogen
owns approximately 71.3% of the outstanding shares of the Company’s common
stock.
The
Company’s financial statements have been prepared in accordance with U.S.
generally accepted accounting principles or “GAAP” for the interim financial
information and with the instructions to Form 10-Q and Article 10 of Regulation
S-X of the Securities Exchange Act of 1934 as amended. Accordingly they do not
include all of the information and footnotes required by GAAP for complete
financial statements. We believe all adjustments (consisting only of normal
recurring adjustments) considered necessary for a fair presentation have been
included herein. Operating results for the three and nine months ended March 31,
2009 are not necessarily indicative of the results that may be expected for the
year ending June 30, 2009 or any other future period. The balance sheet at June
30, 2008 has been derived from the audited financial statements at that date.
You should read these financial statements and notes in conjunction with the
audited financial statements for the year ended June 30, 2008 which are included
in the Company’s Annual Report on Form 10-K filed with the Securities and
Exchange Commission.
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.
Revenue
Recognition
Interest
The only
revenue earned to date is interest on cash balances, which is recognized on an
accruals basis.
7
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 deposits held in Australian banks are guaranteed by the
Australian Government up to a maximum amount of A$1 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.
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. Fair value has been
determined based on the fair value of identical investments in active markets.
All cash and cash equivalents are classified as level 1 as defined by SFAS No.
157. The Company has partially adopted SFAS No. 157 as allowed.
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.
8
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
On
December 9, 2008, the Company adopted the Marshall Edwards, Inc. 2008 Stock
Omnibus Equity Compensation Plan (the “Equity Compensation Plan”) and cancelled
the Marshall Edwards, Inc. Share Option Plan (the “Share Option Plan”). No
options were issued under the Share Option Plan. The Equity Compensation Plan
provides for the issuance of a maximum of 7,000,000 shares of common stock in
connection with the grant of options and/or other stock-based or
stock-denominated awards to the Company’s non-employee directors, officers,
employees and advisors. To date, the Company has issued options exercisable for
50,000 shares of common stock under the Equity Compensation Plan. For further
details, see Note 6 “Equity”.
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
March
31,
|
Nine
Months Ended
March
31,
|
|||
2009
|
2008
|
2009
|
2008
|
|
(In
Thousands, except share and per share data)
|
(In
Thousands, except share and per share data)
|
|||
Numerator
|
||||
Net
loss arising during development stage
|
(1,904)
|
(3,332)
|
(5,755)
|
(9,009)
|
Effect
of dilutive securities
|
-
|
-
|
-
|
-
|
Numerator
for diluted earnings per share
|
$ (1,904)
|
$ (3,332)
|
$ (5,755)
|
$ (9,009)
|
Denominator
|
||||
Denominator
for basic earnings per share:
|
||||
Weighted
average number of shares used in computing net loss per share, basic and
diluted
|
73,463,233
|
68,854,938
|
72,941,857
|
68,119,782
|
Effect
of dilutive securities
|
-
|
-
|
-
|
-
|
Dilutive
potential common shares
|
73,463,233
|
68,854,938
|
72,941,857
|
68,119,782
|
Basic
and diluted earnings per share
|
$ (0.03)
|
$ (0.05)
|
$ (0.08)
|
$ (0.13)
|
During
the period presented, the Company had warrants and stock options 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 and
stock options consist of the following potential common shares:
As
at March 31,
|
||||
2009
|
2008
|
|||
(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
|
-
|
||
Stock
options exercisable prior to January 28, 2014 at an exercise price of
$0.63
|
50,000
|
-
|
||
Common
shares issuable upon exercise of outstanding warrants
|
5,345,303
|
5,249,220
|
10
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 in a registered direct offering.
For further details see Note 6 “Equity”.
During
January 2009, the Company issued stock options exercisable for 50,000 shares of
common stock. For further details see Note 6 “Equity”.
3. Expenditure
Commitments
At March
31, 2009, the Company had contractual obligations for the conduct of clinical
trials, pre-clinical research and development and manufacturing process
development of approximately $14,874,000. 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
|
$ | 14,874 | $ | 9,283 | $ | 4,581 | $ | 1,010 | $ | - | ||||||||||
Total
|
$ | 14,874 | $ | 9,283 | $ | 4,581 | $ | 1,010 | $ | - |
We have
included an amount of $2,000,000 for a milestone licence fee payment
to Novogen under the terms of the Licence Agreement for Triphendiol and NV-143
which becomes due on June 30, 2009 and is not subject to termination provisions.
No other amounts have been included for future payments to Novogen which may
arise in connection with the Phenoxodiol Licence Agreement, the Licence
Agreement for Triphendiol and NV-143, the Services Agreement or the
Manufacturing Licence 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 Licence Agreement, the Manufacturing Licence and Supply
Agreement and the Services Agreement. Novogen has guaranteed the performance of
the obligations of Novogen Research Pty Limited under the Phenoxodiol Licence
Agreement and the obligations of Novogen Laboratories Pty Limited under the
Manufacturing Licence and Supply Agreement to MEPL. Each of the Company and
Novogen’s obligations in the Guarantee and Indemnity Agreement are absolute,
unconditional and irrevocable.
11
It is
expected that the decision to cease patient recruitment from the OVATURE trial
will result in reduced future expenditure commitments, due to the reduced number
of patients participating in the trial and a reduction in the associated
monitoring and trial management costs. As at the date of the report the amount
of such reductions are not able to be estimated.
4. Segment
Information
The
business contains two major operating segments based on geographic
location.
Three
Months Ended
March
31, 2009
|
Three
Months Ended
March
31, 2008
|
|||||||||||||||
(In
Thousands)
|
||||||||||||||||
USA
|
Australia
|
USA
|
Australia
|
|||||||||||||
Loss
from operations
|
$ | (103 | ) | $ | (1,801 | ) | $ | (55 | ) | $ | (3,277 | ) | ||||
Segment
assets
|
16,204 | 7,102 | 22,428 | 770 | ||||||||||||
Nine
Months Ended
March
31, 2009
|
Nine
Months Ended
March
31, 2008
|
|||||||||||||||
(In
Thousands)
|
||||||||||||||||
USA
|
Australia
|
USA
|
Australia
|
|||||||||||||
Loss
from operations
|
$ | (465 | ) | $ | (5,290 | ) | $ | (230 | ) | $ | (8,779 | ) |
5. Related
Party Transactions
Licence
Agreement for Phenoxodiol, as amended
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 Licence Agreement”). The Phenoxodiol Licence
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 Licence 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 Licence 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 Licence 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 Licence Agreement are as follows:
12
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 Licence 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 Licence Agreement,
infringe in any country in the geographical territory covered by the
Phenoxodiol Licence Agreement by doing in that country any of the things
set out in the Phenoxodiol Licence
Agreement.
|
2. In addition to the amounts above,
the Licence Agreement for Phenoxodiol was amended in June 2006 and April 2007 to
provide that upon the earliest receipt (the “Approval Date”) by MEPL of the
first:
(i)
|
approval
by the U.S. Food and Drug Administration (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,
|
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 Licence
Agreement.
No
license fees have been accrued in respect of phenoxodiol at March 31,
2009.
Licence
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 “Licence Agreement for
Triphendiol and NV-143”). Triphendiol is being developed initially in oral form
for the treatment of 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 Licence 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
Licence Agreement
13
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 Licence 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 Investigation 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.
No
license fees have been accrued in respect of triphendiol or NV-143 at March 31,
2009.
Amended
and Restated Licence Option Deed
On
September 24, 2003, MEPL and Novogen Research Pty Limited entered into an
Amended and Restated Licence Option Deed (the “Licence Option Deed”). The
Licence 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.
14
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 $1,713,000 and $2,137,000 were made
under the Services Agreement with Novogen during the nine months ended March 31,
2009 and 2008, respectively. Of these amounts, $1,111,000 and $1,408,000 related
to service fees paid to Novogen for research and development services provided
in the nine months ended March 31, 2009 and 2008, respectively, reflecting the
time spent by Novogen research staff on the development of phenoxodiol,
triphendiol and NV-143. Additionally, $602,000 and $729,000 of the total
expenditures during the nine months ended March 31, 2009 and 2008, respectively,
related to costs incurred for administration and accounting services provided by
Novogen.
At March
31, 2009 and 2008, $194,000 and $560,000, 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
Licence 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 Licence and Supply Agreement”). Under the terms of
the Manufacturing Licence 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.
There
were no transactions under the Manufacturing Licence and Supply Agreement with
Novogen during the nine months ended March 31, 2009. Transactions giving rise to
expenditures amounting to $31,000 were made under the Manufacturing Licence and
Supply Agreement with Novogen during the nine months ended March 31,
2008.
At March
31, 2009 there were no amounts owed to Novogen under the Manufacturing Licence
and Supply Agreement compared to March 31, 2008 which amounted to
$7,000.
15
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 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
16
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 net proceeds of $9.8 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.
In
January 2009, we filed a registration statement on Form S-8 with the SEC
registering 7,000,000 shares of common stock eligible for issuance under the
Equity Compensation Plan.
In
January 2009, the Company issued a stock option exercisable for 50,000 shares of
common stock to Associate Professor Gil Mor of Yale University in recognition of
his contribution to the development of phenoxodiol under the Equity Compensation
Plan. The options have an exercise price of $0.63. The options are exercisable
immediately and expire five years from date of issue.
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.
8.
Significant Events after Balance Sheet Date
In April
2009, the Company announced its determination to terminate enrollment into the
OVATURE Phase III trial and its intention to undertake an un-blinded analysis of
the data from the trial. The patients currently enrolled in the trial
will continue their treatment according to the study
protocol. However, the Company will cease recruiting new patients to
participate in the OVATURE trial and the available data from the 142 completed
and current patients will be analyzed for safety and efficacy
outcomes.
The
Company decided to terminate new enrollment into the OVATURE Phase III trial and
assess the available patient data, in part, because it believes that the global
financial downturn makes it unlikely that the Company will be able to raise the
necessary capital through debt or equity issuances in the near future to fund
the trial to completion as originally planned. Additionally, changes
in the standard of care over the period that the OVATURE trial has been in
operation resulted in fewer women meeting the inclusion criteria of the OVATURE
protocol, which slowed patient recruitment rates.
17
The
Company intends to allocate its current funds of approximately $23 million to
completing the OVATURE data analysis of 142 patients, pursuing negotiations for
out-licensing phenoxodiol should evidence of efficacy and safety emerge from the
OVATURE analysis, maintaining other ongoing phenoxodiol ovarian and prostate
cancer clinical trials, initiating the triphendiol clinical program, and
in-licensing further promising anti-cancer compounds from Novogen.
It is
expected that the decision to cease patient recruitment from the OVATURE trial
will result in reduced future expenditure commitments, due to the reduced number
of patients participating in the trial and a reduction in the associated
monitoring and trial management costs. As at the date of the report the amount
of such reductions are not able to be estimated.
18
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 (the “Exchange Act”). 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;
|
· our
termination of new enrollment into the OVATURE Phase III clinical
trial;
|
· 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 demonstrate the efficacy and safety of phenoxodiol for the
recruitment of platinum resistant
late stage ovarian cancer;
|
· 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;
|
19
· 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 defense 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 and in the Quarterly Report on Form
10-Q for the quarter ended September 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.
20
In April
2009, we announced our determination to terminate enrollment into the OVATURE
Phase III trial and our intention to undertake an un-blinded analysis of the
available data from the trial. The patients currently enrolled in the
trial will continue their treatment according to the study
protocol. However, we will cease recruiting new patients to
participate in the OVATURE trial and the available data from the 142 completed
and current patients will be analyzed for safety and efficacy
outcomes.
We
decided to terminate new enrollment into the OVATURE Phase III trial and assess
the available patient data, in part, because we believe that the global
financial downturn makes it unlikely that we will be able to raise the necessary
capital through debt or equity issuances in the near future to fund the trial to
completion as originally planned. Additionally, changes in the
standard of care over the period that the OVATURE trial has been in operation
resulted in fewer women meeting the inclusion criteria of the OVATURE protocol,
which slowed patient recruitment rates.
We intend
to allocate our current funds of approximately $23 million to completing the
OVATURE data analysis of 142 patients, pursuing negotiations for out-licensing
phenoxodiol should evidence of efficacy and safety emerge from the OVATURE
analysis, maintaining other ongoing phenoxodiol ovarian and prostate cancer
clinical trials, initiating the triphendiol clinical program, and in-licensing
further promising anti-cancer compounds from Novogen.
We
believe that the proceeds from the registered direct offering closed in July
2008 and savings generated from ceasing the OVATURE trial will provide us with
sufficient cash resources to fund these operations over the next twelve
months.
We will,
however, need additional funds in order complete the planned clinical
development programs beyond the current objectives.
As of
March 31, 2009, we had accumulated losses of $57,486,000.
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 Licence Agreement, as amended, the Licence Agreement for Triphendiol
and NV-143, the Services Agreement and the Manufacturing Licence 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.
As at the
date of the Quarterly Report, Novogen owns approximately 71.3% of the
outstanding shares of our common stock.
21
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 March 31, 2009 aggregate
to $30,254,000.
Research
and development costs include clinical trial expenses and are expensed as they
are incurred.
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 who 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.
22
Clinical
trial expenses of $1,260,000 have been accrued at March 31, 2009. 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.
Stock
Based Compensation
On
December 9, 2008, we adopted the Marshall Edwards, Inc. 2008 Stock Omnibus
Equity Compensation Plan (the “Equity Compensation Plan”) and cancelled the
Marshall Edwards, Inc. Share Option Plan (the “Share Option
Plan”). No options were issued under the Share Option Plan. The
Equity Compensation Plan provides for the issuance of a maximum of 7,000,000
shares of common stock in connection with the grant of options and/or other
stock-based or stock-denominated awards to our non-employee directors, officers,
employees and advisors. To date, we have issued options exercisable for 50,000
shares of common stock under the Equity Compensation Plan.
See Note
6 “Equity” for details of options issued under the Equity Compensation Plan in
January 2009.
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, the warrant representing 46,083 warrant shares issued to Mr. J.
O’Connor July 30, 2008, in consideration for investor relations services
rendered, and the stock option representing 50,000 shares of common stock issued
to Associate Professor Gil Mor of Yale University in January 28, 2009, in
recognition of his contribution to the development of phenoxodiol under the
Equity Compensation Plan, the following assumptions were used:
August 6,
2007
|
July
30, 2008
|
January
28, 2009
|
|
Dividend
yield
|
0%
|
0%
|
0%
|
Expected
volatility
|
71%
|
81%
|
111%
|
Historical
volatility
|
71%
|
81%
|
111%
|
Risk-free
interest rate
|
4.13%
|
3.36%
|
1.70%
|
Expected
life of warrant
|
5
years
|
5
years
|
5
years
|
Warrant
fair value
|
$1.777
|
$1.41
|
$0.50
|
23
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 or stock 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.
Results
of Operations
Three
Months Ended March 31, 2009 and 2008
We
recorded a consolidated loss of $1,904,000 and $3,332,000 for the three months
ended March 31, 2009 and 2008, respectively.
Revenues: We received interest
on cash assets and cash equivalents and short term investments of $29,000 for
the three months ended March 31, 2009 compared to $149,000 for the three months
ended March 31, 2008. The decrease was primarily due to lower interest rates in
the U.S. earned by our cash deposits.
Research and Development:
Research and development expenses decreased $315,000 to $1,545,000 for the three
months ended March 31, 2009 compared to $1,860,000 for the three months ended
March 31, 2008. The reduction was due to reduced costs associated with the
recruitment into the OVATURE trial and reduced service fees charged by Novogen
in $A, as a result of falling $A compared to the $US .
Selling, General and Administrative:
Selling, general and administrative expenses decreased by $232,000 to
$388,000 for the three months ended March 31, 2009 compared to $620,000 for the
three months ended March 31, 2008. The decrease was due to net foreign exchange
gains (described below), reduced spending on public relations, reduced travel
expenses and reduced service fees charged by Novogen in $A, as a result of
falling $A compared to the $US.
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 and there is a possibility that
foreign exchange gains/losses may have a material impact in future periods. At
March 31, 2009, we had not established a foreign currency hedging program. Net
foreign exchange gains during the three months ended March 31, 2009 were $1,000
compared with foreign exchange losses of $61,000 during the three months ended
March 31, 2008.
Nine
months Ended March 31, 2009 and 2008
We
recorded a consolidated loss of $5,755,000 and $9,009,000 for the nine months
ended March 31, 2009 and 2008, respectively.
24
Revenues: We received interest
on cash assets and cash equivalents and short term investments of $201,000 for
the nine months ended March 31, 2009 compared to $582,000 for the nine months
ended March 31, 2008. The decrease was primarily due to lower interest rates in
the U.S. earned by our cash deposits.
Research and Development:
Research and development expenses decreased $1,643,000 to $4,988,000 for the
nine months ended March 31, 2009 compared to $6,631,000 for the nine months
ended March 31, 2008. The reduction was due to reduced manufacturing scale-up
costs of phenoxodiol, reduced expenditure relating to the development of
triphendiol, reduced costs associated with the recruitment into the OVATURE
trial and reduced service fees charged by Novogen in $A, as a result of falling
$A compared to the $US.
Selling, General and Administrative:
Selling, general and administrative expenses decreased by $990,000 to
$967,000 for the nine months ended March 31, 2009 compared to $1,957,000 for the
nine months ended March 31, 2008. The decrease was primarily due to net foreign
exchange gains, as described below, and reduced spending on public relations and
travel, partially offset by additional legal fees and share based payment
expense incurred in the nine months ended March 31, 2009.
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 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 and there is a possibility
that foreign exchange gains/losses may have a material impact in future periods.
At March 31, 2009, we had not established a foreign currency hedging program.
Net foreign exchange gains during the nine months ended March 31, 2009 were
$558,000 compared with foreign exchange losses of $159,000 during the nine
months ended March 31, 2008.
Liquidity
and Capital Resources
At March
31, 2009, we had cash resources of $23,152,000 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. 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.
25
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.
In
January 2009, we issued the stock option exercisable for 50,000 shares of common
stock to Associate Professor Gil Mor of Yale University in recognition of his
contribution to the development of phenoxodiol under the Equity Compensation
Plan. The options have an exercise price of $0.63. The options are exercisable
immediately and expire five years from date of issue.
26
Given the
current state of the global financial markets, we do not expect to be able to
raise additional capital through the issuance of equity or debt in the near
term.
Source
and Uses of Cash
Cash
Used in Operating Activities
Cash used
in operating activities for the nine months ended March 31, 2009 was $6,469,000
compared to $8,397,000 for the same period in 2008.
Cash
Requirements
The
Company intends to allocate its current funds of approximately $23 million to
completing the OVATURE data analysis of 142 patients, pursuing negotiations for
out-licensing phenoxodiol should evidence of efficacy and safety emerge from the
OVATURE analysis, maintaining other ongoing phenoxodiol ovarian and prostate
cancer clinical trials, initiating the triphendiol clinical program, and
in-licensing further promising anti-cancer compounds from Novogen.
Specifically
we intend to:
·
|
Complete
the Phase Ib/IIa study of phenoxodiol in combination with the
Sanofi-Aventis drug Docetaxel (TaxotereÒ) in ovarian cancer
currently underway at the Yale University School of
Medicine;
|
·
|
Complete
at Yale, the Phase II clinical trial of phenoxodiol comparing its safety
and efficacy in patients with early stage and advanced prostate
cancer.
|
·
|
Commence
the development of the drug candidate triphendiol (NV-196), for which an
Investigational New Drug Application (“IND”) has been granted by the FDA,
allowing clinical trials to commence in the U.S. for pancreatic and bile
duct cancers. In addition, this drug was designated by the FDA as an
Orphan Drug for treatment of pancreatic cancer, bile duct cancer, and late
stage melanoma;
|
·
|
Complete
negotiations with Novogen to in-licence the mTOR inhibitor NV-128, which
has shown compelling preclinical results to
date.
|
Ongoing
operations through the conduct of the clinical trial program will continue to
consume cash resources without generating revenues. 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 fund our programs or find
appropriate collaboration or licensing opportunities.
Payments
to Novogen
Future
payments to Novogen under the terms of the Phenoxodiol Licence Agreement, as
amended and the Licence 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.
27
We will
also be required to make payments to Novogen under the Services Agreement and
Manufacturing Licence 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.
Contractual
Obligations
For
details of our contractual obligations at March 31, 2009 see Note 3 to the
financial statements “Expenditure Commitments” on page 11 of this Quarterly
Report.
28
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 March 31, 2009, we had not established a foreign currency hedging
program. Net foreign exchange gains during the nine months ended March 31, 2009
were $558,000 compared with net foreign exchange losses of $159,000 during the
nine months ended March 31, 2008. 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 and there is a possibility that foreign exchange
gains/losses may have a material impact in future periods.
We do not
consider the effects of foreign currency movements to be a material risk to our
financial condition.
29
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 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 and have ensured that
information required to be disclosed by us in such reports is accumulated and
communicated to our management, including our principal executive officer and
principal financial officer, as appropriate to allow timely decisions
regarding required disclosures.
There
were no changes in our internal control over financial reporting during the
period covered by this Quarterly Report that have materially affected, or are
reasonably likely to materially affect, the Company’s internal control over
financial reporting.
30
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 and our Quarterly Report on Form 10-Q
for the quarter ended September 30, 2008, 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
have terminated new enrollment into our OVATURE Phase III trial and may not be
able to pursue commercialization of phenoxodiol at this time.
We have
terminated new enrollment into the OVATURE Phase III trial, in part, because we
believe that the global financial downturn makes it unlikely that we will be
able to raise the necessary capital through debt or equity issuances in the near
future to fund the trial to completion as originally planned. We have ceased
recruiting the necessary number of additional patients to complete the trial as
originally planned. As a result of our termination of new enrollment into the
OVATURE Phase III trial, we may not be able to pursue commercialization of
phenoxodiol at this time.
If
our un-blinded data analysis of the patient data from the OVATURE Phase III
trial does not demonstrate the safety and efficacy of phenoxodiol for the
treatment of platinum-resistant late-stage ovarian cancer, we may be unable to
out-license phenoxodiol to third parties for this purpose.
We have
decided to undertake an un-blinded analysis of the available data from the 142
completed or current patients in the OVATURE Phase III trial to assess the
safety and efficacy of phenoxodiol for the treatment of platinum-resistant
late-stage ovarian cancer. If our analysis demonstrates the safety and efficacy
of phenoxodiol, we may be able to out-license phenoxodiol to third parties and
receive licensing revenues. If our analysis shows that phenoxodiol is
not safe and /or not effective, however, we may not be able to out-license
phenoxodiol to third parties.
31
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).
|
32
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.
Seaton
Chief
Financial Officer
(Duly
Authorized Officer and Principal Financial Officer)
Date: May
1, 2009
33
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.
|
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.
|
/s/CHRISTOPHER NAUGHTON
Christopher
Naughton
Chief
Executive Officer
Date: May 1,
2009
34
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.
|
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.
|
/s/ DAVID SEATON
David R.
Seaton
Chief
Financial Officer
Date: May
1,
2009
35
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 March 31,
2009, (the “Form 10-Q”) to which this Certification is attached as Exhibit
32.1, 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.
/s/
CHRISTOPHER
NAUGHTON
Christopher
Naughton
Chief Executive Officer
Chief Executive Officer
/s/ DAVID
SEATON
David R.
Seaton
Chief
Financial Officer
Dated: May 1, 2009
36