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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended June 30, 2007
OR
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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)
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DELAWARE
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51-0407811 |
(State or other jurisdiction of
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(I.R.S. Employer Identification No.) |
Incorporation or organization) |
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140 Wicks Road, North Ryde, NSW, 2113 Australia
(Address of principal executive offices) (Zip Code)
Registrants telephone number, including area code:
(011) 61 2 8877- 6196
Securities registered pursuant to Section 12(b) of the Act:
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Name of Each Exchange on which |
Title of Each Class
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Registered |
Common Stock, $0.00000002 par value
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Nasdaq Global Market |
Securities registered pursuant to Section 12(g) of the Act:
None
(Title of Class)
Indicate by a check mark if the registrant is a well-known seasoned issuer, as defined in Rule
405 of the Securities Act. Yes o No þ
Indicate by a check mark if the registrant is not required to file reports pursuant to Section
13 or Section 15(d) of the Act. Yes
o No þ
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
þ No o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K
(Section 229.405 of this chapter) is not contained herein, and will not be contained, to the best
of the registrants knowledge, in definitive proxy or information statements incorporated by
reference in Part III of this Form 10-K or any amendment to this Form 10-K.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 þ
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
The aggregate market value of the voting common equity held by non-affiliates of the
registrant was approximately $42.5 million based on the closing price of the registrants Common
Stock as reported on the Nasdaq Global Market on December 29, 2006.
As of August 31, 2007, the number of shares outstanding of the issuers common stock, $0.00000002
par value, was 68,854,938.
Documents Incorporated by Reference
Portions of this registrants definitive proxy statement for its 2007 annual meeting to be filed
with the U.S. Securities and Exchange Commission no later than 120 days after the end of the fiscal
year are incorporated by reference in Part III of this Annual Report on Form 10-K.
MARSHALL EDWARDS, INC.
TABLE OF CONTENTS
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PART I |
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Item 1: Business |
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Item 1A: Risk Factors |
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Item 1B: Unresolved Staff Comments |
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Item 2: Properties |
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Item 3: Legal Proceedings |
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Item 4: Submissions of Matters to a Vote of Security Holders |
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PART II |
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Item 5: Market for the Registrants Common Equity, Related Stockholder
Matters and Issuer Purchases of Securities |
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Item 6: Selected Financial Data |
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Item 7: Managements Discussion and Analysis of Financial Condition
and results of Operations |
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Item 7a: Quantitative and Qualitative Disclosures about Market Risk |
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Item 8: Financial Statements and Supplementary Data |
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Item 9: Changes in and Disagreements with Accountants on Accounting
and Financial Disclosure |
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Item 9a: Controls and Procedures |
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Item 9b: Other Information |
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PART III |
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Item 10: Directors and Officers of the Registrant |
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Item 11: Executive Compensation |
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Item 12: Security Ownership of Certain Beneficial Owners and
Management and Related Stockholder Matters |
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Item 13: Certain Relationships and Related Transactions |
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Item 14: Principle Accountant Fees and Services |
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PART IV |
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Item 15: Exhibits and Financial Statement Schedules |
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Cautionary Statement about Forward-Looking Statements
This Annual Report on Form 10-K 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 Annual
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 us, 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 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, without
limitation, those described in Risk Factors and elsewhere in this Form 10-K, including, among
other things:
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our limited operating history; |
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our inability to obtain required additional financing or financing
available to us on acceptable terms; |
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costs and delays in the development and/or receipt of U.S. Food and Drug
Administration (the FDA) or other required governmental approvals, or the
failure to obtain such approvals, for our product candidates; |
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uncertainties in clinical trial results; |
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our failure to successfully commercialize our product candidates; |
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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; |
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our inability to control the costs of manufacturing our products; |
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continued cooperation and support of Novogen Limited, our parent company; |
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competition and competitive factors; |
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our inability to protect our patents or proprietary rights and obtain
necessary rights to third party patents and intellectual property to operate our
business; |
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our inability to operate our business without infringing the patents and
proprietary rights of others; |
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costs stemming from our defence against third party intellectual property
infringement claims; |
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difficulties in enforcement of civil liabilities against our officers and
directors who are residents of jurisdictions outside the United States; |
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general economic conditions; |
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the failure of any products to gain market acceptance; |
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technological changes; |
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government regulation generally and the receipt of the regulatory
approvals; |
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changes in industry practice; and |
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one-time events. |
These risks are not exhaustive. Other sections of this Annual Report on Form 10-K includes
additional factors which could adversely impact our business and financial performance. Moreover,
we operate in a very competitive and rapidly changing environment. New risk factors emerge from
time to time and it is not possible for us to predict all risk factors, nor can we assess the
impact of all factors on our business or the extent to which any factor, or combination of factors,
may cause actual results to differ materially from those contained in any forward-looking
statements.
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 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.
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PART I
Item 1. Business
Overview of Our Business
We are a developmental stage pharmaceutical company listed on the Nasdaq Global Market under the
symbol MSHL. We were incorporated on December 1, 2000 as a wholly-owned subsidiary of Novogen
Limited (Novogen), an Australian company. Novogens ordinary shares trade on the Australian Stock
Exchange under the symbol NRT, and American Depositary Receipts trade in the United States under
the symbol NVGN on the Nasdaq Global Market. As at the date of this report Novogen owns
approximately 71.9% of our outstanding common stock.
We commenced operation in May 2002 and our business purpose is the development and
commercialization of drugs for the treatment of cancer. We are presently engaged in the clinical
development and commercialization of a drug candidate called phenoxodiol which we have licensed
from a subsidiary of Novogen. We believe that phenoxodiol may have broad application against a wide
range of cancers. Phenoxodiol appears to target a number of key components involved in cancer cell
survival and proliferation based on the emerging field of signal transduction regulation, with
little or no effect on normal cells detected in pre-clinical testing. We have also licensed two
other anti-cancer compounds, NV-196 and NV-143, from a subsidiary of Novogen.
Our strategy is to undertake further clinical development and testing of phenoxodiol, focusing on
those therapeutic indications that will expedite drug marketing approval by regulatory bodies,
leading to phenoxodiols commercialization and wide scale distribution. We also plan to develop
NV-196 and NV-143 for therapeutic indications not currently targeted by phenoxodiol.
Phenoxodiol commenced Phase I clinical studies in Australia in 2000 and currently is undergoing a
pivotal Phase III study in combination with carboplatin for women with platinum-resistant ovarian
cancer (ovarian cancer that does not respond to platinum based anti-cancer agents such as cisplatin
and carboplatin), and has recently completed a Phase Ib study in the United States in patients with
cervical cancer and a Phase Ib study in Australia in patients with hormone-refractory prostate
cancer.
NV-196 is being developed initially in oral form for pancreatic and bile duct cancer and has
completed a Phase I human clinical trial. NV-143 is targeted for the treatment of melanoma also in
oral dose form and is in the pre-clinical testing stage.
Recent Developments
In April 2007, we announced that we had renegotiated with Novogen the timing of the payments of our
annual $8.0 million milestone license payments for phenoxodiol due under the terms of our license
agreement. Under the terms of an Amendment Deed to the original license agreement the payment of
the future milestone license fees due on December 31, 2007 and each year subsequently will now
commence at the end of the calendar year in which the FDA approves a new drug application for
phenoxodiol or phenoxodiol first receives approval for marketing in the U.S. or any other country.
In April 2007, we announced that Novogen had advised us that it had been granted patent claims in
the United States to pharmaceutical compositions of phenoxodiol. These rights are included in the
patent rights licensed to us under the terms of our license agreement.
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On August 1, 2007, we entered into a securities subscription agreement with certain accredited
investors providing for the private 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. 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, on 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 gross proceeds of
$16.4 million.
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 U.S. 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.
In addition, we have terminated our Standby Equity Distribution Agreement (the SEDA), dated as of
July 11, 2006, with Cornell Capital Partners, LP, as amended.
Recent Clinical Developments
During fiscal year 2007, we made progress in the clinical development of phenoxodiol including:
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In September 2006, we announced the results of a preclinical study conducted at Purdue
University which suggests that phenoxodiol may be effective in the treatment of prostate
cancer through its ability to target a protein, the 75 alpha protein, an isoform of
tumor-associated NADH oxidase (or tNOX), which appears to be the particular tNOX isoform
found in prostate cancer patients. This study provides further support that a surface
oxidase is a target for phenoxodiol. |
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In November 2006, we announced that the first patient commenced treatment in the Phase
III OVATURE clinical trial (known as OVATURE). The OVATURE trial is being conducted under a
Special Protocol Assessment (SPA) where the U.S. Food and Drug Administration (the
FDA) in the U.S. reviewed and agreed with the study design of the pivotal Phase III study
of phenoxodiol in combination with carboplatin for women with platinum-resistant ovarian
cancer. The SPA process allows for FDA evaluation of a clinical trial protocol that will
form the basis of an efficacy claim for a marketing application, and provides
acknowledgement that the study design including patient numbers, clinical endpoints and
analyses, are acceptable to the FDA. As a fast track product, phenoxodiol will be eligible
to apply for accelerated approval and priority review of the marketing application by the
FDA for this indication. |
New Director
In March 2007, the Board of Directors appointed Mr. William Rueckert to the Board. Mr. Rueckert is
the Managing Member of Oyster Management Group LLC an investment fund specializing in community
banks. Mr. Rueckert is a Director of Emergency Filtration Products, Inc., a public manufacturer and
marketer of respiratory filtration devices and Mr. Rueckert is a
member of the Board of Directors of
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Glycotex, Inc. an 81.3 percent owned unlisted subsidiary of Novogen Limited. Prior
to his current positions, from 1991 to 2006 he was president and director of Rosow & Company, a
private investment firm based in Connecticut. Mr. Rueckert has been president and director of
Eastern Capital Development, LLC from 1999 to 2005, treasurer of Moore & Munger, Inc., a company
with interests in the petroleum and resort development industries, from 1988 until 1990, and was
president of United States Oil Company, a publicly traded oil exploration business, from 1981 to
1988. Among his many civic associations, Mr. Rueckert is director and president of the Cleveland H.
Dodge Foundation, a private philanthropic organization in New York City and Chairman of the Board
of the Trustees of Teachers College, Columbia University.
In June 2007, we announced that Dr Graham Kelly had retired as a member of our Board of Directors.
Scientific Overview
Phenoxodiol, NV-196 and NV-143 belong to a class of drugs that we refer to as Multiple Signal
Transduction Regulators (MSTRs).
Signal transduction refers to the means by which cells respond to chemical signals that come from
within the cell itself, from neighboring cells, and from elsewhere in the body. These signals
regulate such vital functions as the growth and survival of the cell. We believe that malfunctions
in key components of the signal transduction process (whereby a series of chemical signals within a
cell leads to the expression of a particular function) are fundamental to neoplastic diseases such
as cancer, where cells respond abnormally to normal levels of signals, typically by over-responding
to them with increased cell growth and survival.
We believe that identifying malfunctions in the signal transduction process and then designing
drugs to block or correct them has become a basis for the development of the next generation of
anti-cancer drugs. These drugs have become known as signal transduction inhibitors. These drugs are
being designed to target a specific signaling pathway, which typically is over-active in a tumor
cell, and by blocking progression of the signal, prevent or reduce the ability of the tumor cell to
divide or to survive. We believe that single signal transduction inhibitors, while displaying
anti-tumor activity against a small number of different types of cancer, generally have failed to
provide more than modest prolongation of survival of cancer patients. We believe this is because
most human cancers involve errors of multiple signaling pathways, and inhibition of a single
pathway by any one drug alone cannot reasonably be expected to provide more than a temporary halt
to cancer progression.
We believe that our three drug candidates increase the potency of signal transduction inhibitors by
targeting multiple signaling pathways, and in particular, those pathways vital to the survival of
most, if not all, human cancer cells. In the term MSTR, multiple refers to the fact that more
than one signaling pathway is targeted by the drug, and regulator refers to the fact that while
the drug predominantly inhibits errant pro-survival signaling pathways, it conversely can also
activate pro-death signaling pathways to facilitate cancer cell death.
We believe that our three drug candidates are able to exert a multiplicity of effects, including
both pro-survival and pro-death signaling systems, as a result of the primary target on the
tumor cell being a protein whose function in the tumor cell is so fundamental to cell biochemistry
that to shut it down produces a broad range of adverse biochemical consequences.
The potential explanation for this effect on the fundamental biochemistry of tumor cells was
provided by a discovery of a research team at Purdue University in Indiana. This team has a
long-standing research interest in a family of proteins at the cell surface that are involved in
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electron
transport across the cell membrane. This function is so fundamental to normal cell function and viability, that any
loss of function of this electron pump will disrupt a wide range of biochemical processes. One of
the key components of this electron pump mechanism is a cell surface protein known as NADH oxidase.
These proteins are situated on the outside of the cell membrane of all living matter, and regulate
the flow of waste hydrogen across the cell membrane. The Purdue University studies have now shown
that all forms of human cancer express a variant form of the surface oxidase, known as
tumor-specific NADH oxidase. In cancer cells, phenoxodiol appears to block the surface oxidase,
with the resulting inhibition of hydrogen ion removal (H+ efflux) from the cell. This leads to
extensive disruption to signaling pathways and to eventual inhibition of cell proliferation and
activation of apoptosis, the process of programmed cell death by which a cell dies naturally.
Phenoxodiol appears to have little or no effect on the normal cell form of oxidase, providing an
explanation for how phenoxodiol selectively targets cancer cells for its cytotoxic effects.
A research
team at Victoria University in New Zealand, headed by Professor Michael Berridge, head
of the Malaghan Institute of Medical Research at the University of Wellington School of Medicine,
has independently validated the mechanism of action of phenoxodiol via surface oxidase inhibition.
Phenoxodiol inhibited plasma membrane electron transport and cell proliferation in cancer cell
lines and some primary immune cells.
Other
studies at The Hanson Institute, Centre for Cancer Research at Royal Adelaide Hospital in Australia have
demonstrated that the potent anti-tumour and anti-angiogenic properties of phenoxodiol are
associated with down regulation of a key signal transduction molecule, sphingosine kinase.
Sphingosine kinase is a terminal component of the plasma membrane sphingomyelin pathway leading to
the formation of sphingosine-1-phosphate, a key pro-survival secondary messenger acting via the
signal transduction protein kinase (Akt). Two important biological outcomes of this are (i)
cytostasis, through p53-independent induction of the cell cycle regulatory protein, p21WAF1/CIP1,
and (ii) apoptosis, through inhibition of phosphorylation of the anti-apoptotic factors, XIAP
(inhibitor of apoptosis protein) and FLIPshort (caspase-8 inhibitory protein ) ,
thereby facilitating activation of executioner caspases via the tumour necrosis factor (TNF) family
of death receptors. The Purdue group have shown this effect is a consequence of the interaction
between phenoxodiol and the surface oxidase on cancer cells.
This finding is relevant because of results from laboratory studies at Yale University that have
revealed that the killing effect of phenoxodiol on cancer cells occurs through the loss of the
ability of the tumor cell to manufacture anti-apoptosis proteins such as XIAP and c-FLIP.
Collectively, these third party studies provide a rational mechanism of action of phenoxodiol
starting with the inhibition of surface oxidase, leading in turn to the loss of intracellular
sphingosine-1-phosphate (S-1-P), and eventually to the loss of anti-apoptosis proteins.
Recent laboratory studies conducted by Novogen and Yale University have confirmed that this chain
of biochemical events following exposure of tumor cells to phenoxodiol also provides an explanation
for why phenoxodiol is able to reverse resistance to standard anti-cancer drugs such as platinums,
gemcitabine and taxanes.
Phenoxodiol appears to restore sensitivity to these drugs in cells such as ovarian cancer cells
that have acquired resistance to these drugs. In addition, pretreatment of tumor cells with
phenoxodiol considerably increases the sensitivity of non-resistant tumor cells to the cytotoxic
effects of standard chemotherapy drugs. These effects are achieved without increasing the toxicity
of the standard chemotherapy drugs to non tumor-cells.
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Overall Clinical Development Strategy for Phenoxodiol, NV-196 and NV-143
Phenoxodiol
Based on the early clinical and pre-clinical work conducted on phenoxodiol, we believe that
phenoxodiol has the potential to become a treatment option for a wide range of human cancers, and
to be employed at various stages of cancer development ranging from early-stage cancer through to
late-stage cancer.
The immediate priority is to focus on those therapeutic indications that will expedite drug
marketing approval of phenoxodiol by regulatory bodies. To this end, we will continue to focus on
three forms of cancer ovarian cancer, prostate adenocarcinoma, and squamous cell carcinoma of the
cervix and vagina.
In ovarian cancer, we are testing the ability of phenoxodiol to overcome chemotherapy drug
resistance mechanisms, reversing resistance to platinums and taxanes in particular. This is a Phase
III pivotal study (known as OVATURE) in patients who have become resistant or refractory to at
least 2 lines of platinum therapy, where phenoxodiol will be tested in combination with weekly
carboplatin to delay tumor progression as measured by progression-free survival.
Phenoxodiol also is being developed for use in squamous cell carcinoma (SCC) of the cervix, vagina
and vulva. A Phase I study is ongoing with a view to providing evidence of both a biological and
clinical effect in this aggressive form of cancer. A positive outcome in the current study could
lead to two potential therapeutic indications: (i) the use of phenoxodiol as a monotherapy in
early-stage disease including pre-malignant disease; and (ii) the use of phenoxodiol in combination
with standard drugs such as cisplatin for the treatment of non-resectable disease.
Prostate cancer is the third tumor type that we believe is likely to be responsive to phenoxodiol
therapy. We have completed a Phase II study in advanced hormone refractory disease and we are
currently assessing the feasibility of conducting a Phase II study using phenoxodiol as first line
treatment in early stage disease. Both of these studies address areas of unmet medical need in this
common cancer. Our ability to proceed with all these studies concurrently will depend on available
financial resources.
NV-196 and NV-143
NV-196, is a synthetic anti-cancer compound developed by Novogen, based on an isoflavan ring
structure. Similar to phenoxodiol, NV-196 is a signal transduction inhibitor. Preliminary screening
studies conducted by Novogen have identified NV-196 as a candidate for product development showing
a favorable in vitro toxicity profile against normal cells and broad activity against cancer cells.
NV-196 is currently in Phase I human testing and is being developed initially in oral form for the
treatment of pancreatic and bile duct cancers.
NV-143 is currently in pre-clinical testing. Preliminary screening studies have identified broad
anti-cancer activity against cancer cells representative of melanoma, glioma, prostate, ovarian,
breast and lung cancer. NV-143 also exhibits broadly acting chemo-sensitizing activity or the
ability to increase the sensitivity of cells to chemotherapeutic drugs that are used to control the
growth of cancer cells. Ongoing research is being undertaken to establish the mechanisms by which
NV-143 elicits its anti-cancer/chemo-sensitizing effect. NV-143 is initially being developed to
target the treatment of melanoma.
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Both of these new drug candidates are analogues of phenoxodiol, but exhibit significantly different
biologies to phenoxodiol. In parallel with phenoxodiol, both drug candidates display pre-clinical
anti-cancer activity across a broad range of tumor types, high selectivity for cancer cells, and
the ability to chemo-sensitize tumor cells to the cytotoxic effects of most standard chemotoxic
drugs. However, both drugs differ from phenoxodiol in showing a substantially greater ability to
induce apoptosis in pancreatic cancer, bile duct cancer, and melanoma cells; they also show an
ability to increase the sensitivity of cancer cells to radiotherapy (radiosensitizers).
We are now engaged in a program that seeks to bring both drug candidates to market as agents that
will provide chemo-sensitization and/or radio-sensitization across a number of tumor types, but
particularly pancreatic cancer, bile duct cancer for NV-196 and malignant melanoma for NV-143.
The first NV-196 Phase Ia study in three patients confirmed the bioavailability of the oral dosage
form. That study showed that an oral dosing regimen had the potential to deliver
therapeutically-relevant plasma levels of the drug, and that short-term therapy with NV-196 was
well tolerated. NV-196 has also completed a second Phase Ia safety and pharmacokinetic (how the
drug is absorbed and metabolised) study in nine patients at the Brisbane Mater Hospital.
NV-143 is still undergoing pre-clinical evaluation for determination of its potential in the
treatment of malignant melanoma and is not expected to enter clinical trials until the results of
pre-clinical testing are complete.
Competition
The development of phenoxodiol and other drug candidates is highly competitive. A number of other
companies have products or drug candidates in various stages of pre-clinical or clinical
development that are intended for the same therapeutic indications for which phenoxodiol is being
developed. Some of these potential competing drugs are further advanced in development than
phenoxodiol and may be commercialized sooner. Even if we are successful in developing effective
drugs, phenoxodiol may not compete successfully with products produced by our competitors.
Our competitors include pharmaceutical companies and biotechnology companies, as well as
universities and public and private research institutions. In addition, companies active in
different but related fields represent substantial competition for us. Many of our competitors
developing oncology drugs have significantly greater capital resources, larger research and
development staffs and facilities and greater experience in drug development, regulation,
manufacturing and marketing than we do. These organizations also compete with Novogen, our services
provider, in recruiting qualified personnel. They compete with us in recruiting eligible patients
to participate in clinical studies and in attracting partners for joint ventures. They also licence
technologies that are competitive with our technologies. As a result, our competitors may be able
to more easily develop technologies and products that would render our technologies or our drug
candidates obsolete or non-competitive.
Intellectual Property
Novogen has been granted patents and has additional patent applications pending in a number of
countries which cover a family of chemically related compounds with potentially broad ranging and
complementary anti-cancer effects. Novogen has granted to us an exclusive licence, with respect to
its patent rights and intellectual property know-how to develop, market and distribute any one of
these compounds, phenoxodiol, NV-143 and NV-196. as anti-cancer agents, except in topical form.
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Phenoxodiol
We have licensed from Novogen the rights to the Novogen patents and applications as they relate to
phenoxodiol as an anti-cancer agent. Excluded from these rights is phenoxodiol in a topical
formulation. The patent rights we have licensed from Novogen can be largely classified into two
broad groups: patent rights relating to phenoxodiol used as an anti-cancer agent, which we refer to
as therapeutic patent rights, and patent rights relating to the manufacture of phenoxodiol for
anti-cancer purposes, which we refer to as manufacturing patent rights. The pending and issued
Novogen patent rights can be further broken down into four families, three families belonging to
the therapeutic patent rights and one family belonging to the manufacturing patent rights. The
three families in the therapeutic patent rights relate to:
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phenoxodiol in the treatment of cancer (thirteen patents pending and ten patents issued); |
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compositions and methods for protecting skin from ultraviolet induced immunosuppression
and skin damage, including phenoxodiol (five patents pending and eight patents issued); and |
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therapeutic methods and compositions involving isoflav-3-ene and isoflavan structure,
including phenoxodiol (twelve patents pending and one patent granted). |
The family relating to the manufacturing patent rights relate to:
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the production of isoflavone derivatives, including phenoxodiol (fourteen patents pending
and four patents issued; one of these pending applications has recently been allowed and is
anticipated to proceed to grant in the coming months). |
Regarding the treatment of cancer, Novogen has been granted a U.S. Patent (No. 6,649,648) by the
United States Patent and Trademark Office (USPTO) relating to the treatment of cancerous disease
with isoflavone derivatives including phenoxodiol. U.S. Patent 6,649,648 also includes claims
specifically directed to the treatment of ovarian cancer, breast cancer, prostate cancer, uterine
cancer, bowel cancer, testicular cancer, endometrial cancer, leukemia and metastatic cancer with
isoflavone derivatives including phenoxodiol.
More recently, Novogen has been granted U.S. Patent No. 7,202,273 with broad claims to
pharmaceutical compositions comprising phenoxodiol.
NV-143 and NV-196
We have also licensed from Novogen the rights to patent applications as they relate to two novel
anti-cancer compounds, NV-143 and NV-196. These compounds are isoflavan derivatives of phenoxodiol.
The licensed patent rights relate to the novel compounds themselves (composition of matter
rights) and to uses of these compounds as anti-cancer agents and sensitizers of cancer cells and
tumors to chemotherapy and radiotherapy. The patent rights fall into two families of patent
applications:
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composition of matter rights in respect of NV-143 and NV-196 and uses of these compounds
as anti-cancer agents (four national patents, twelve pending patent applications and one
international Patent Co-operation Treaty (PCT) pending); and |
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uses of NV-143 and NV-196 as chemo-sensitizers and radiosensitizers of tumors and cancer
cells (eleven patents pending). |
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As patent applications in the United States are maintained in secrecy until published by the USPTO
at 18 months from filing, for all cases filed after November 29, 2000, or at issue, for cases filed
prior to November 29, 2000. We cannot be certain that Novogen was the first to make the inventions covered
by the Novogen patents and applications referred to above. Additionally, publication of discoveries
in the scientific or patent literature often lag behind the actual discoveries. Moreover, pursuant
to the terms of the Uruguay Round Agreements Act, patents filed on or after June 8, 1995 have a
term of twenty years from the date of such filing, irrespective of the period of time it may take
for such patent to ultimately issue. This may shorten the period of patent protection afforded to
therapeutic uses of phenoxodiol or to NV-143 or NV-196, as patent applications in the
biopharmaceutical sector often take considerable time to issue. However, in some countries the
patent term may be extended.
In order to protect the confidentiality of our technology, including trade secrets and know-how and
other proprietary technical and business information, we require all of our consultants, advisors
and collaborators to enter into confidentiality agreements that prohibit the use or disclosure of
information that is deemed confidential. The agreements also oblige our consultants, advisors and
collaborators to assign to us developments, discoveries and inventions made by such persons in
connection with their work with us relating to our products. We cannot be sure that confidentiality
will be maintained or disclosure prevented by these agreements. We also cannot be sure that our
proprietary information or intellectual property will be protected by these agreements or that
others will not independently develop substantially equivalent proprietary information or
intellectual property.
The pharmaceutical industry is highly competitive and patents may have been applied for by, and
issued to, other parties relating to products competitive with phenoxodiol, NV-143 or NV-196. Use
of these compounds and any other drug candidates may give rise to claims that they infringe the
patents or proprietary rights of other parties, existing now and in the future. An adverse claim
could subject us to significant liabilities to such other parties and/or require disputed rights to
be licensed from such other parties. We cannot be sure that any licence required under any such
patents or proprietary rights would be made available on terms acceptable to us, if at all. If we
do not obtain such licences, we may encounter delays in product market introductions, or may find
that the development, manufacture or sale of products requiring such licences may be precluded. We
have not conducted any searches or made any independent investigations of the existence of any
patents or proprietary rights of other parties.
Relationship with Novogen
Novogen has been granted patents and has additional patent applications pending in a number of
countries pertaining to phenoxodiols family of compounds (and to phenoxodiol itself) in their use
in anti-cancer therapeutics. Novogen has granted to us an exclusive licence under its patent rights
and intellectual property rights in its relevant know-how to develop, market and distribute all
forms of administering phenoxodiol for anti-cancer applications, except topical applications.
In May 2006, under the terms of the licence option deed with Novogen, we licenced two oncology
compounds, NV-196 and NV-143, which qualified as option compounds. 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
pre-clinical testing stage. Under the terms of the licence agreement for NV-196 and NV-143, Novogen
has granted to us an exclusive licence under its patent rights and the intellectual property rights
in its relevant know-how to develop, market and distribute all forms of administering NV-196 and
NV-143 for anti-cancer applications, except topical applications.
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Novogen is active in the discovery and development of new drugs based on the emerging field of
signal transduction regulation. Signal transduction regulators offer the potential for effective,
well-tolerated treatment of common diseases, including cancer. Novogen has developed a family of
chemically related compounds with potentially broad ranging and complementary anti-cancer effects.
We have entered into certain key agreements with Novogen which are discussed below.
Phenoxodiol
Under the licence agreement, Novogen granted us an exclusive world-wide, non-transferable licence,
under the Novogen patent rights, to conduct clinical trials and commercialize and distribute all
forms of administering phenoxodiol except topical applications. The agreement covers uses of
phenoxodiol in the field of prevention, treatment or cure of cancer in humans. Our business is
currently focused on advancing the clinical program underway for the development of phenoxodiol.
NV-196 and NV-143
Under a second licence agreement, Novogen granted us an exclusive world-wide, non-transferable
licence, under the Novogen patent rights, to conduct clinical trials and commercialize and
distribute all forms of administering NV-196 and NV-143, except topical applications. The agreement
covers uses of NV-196 and NV-143 in the field of prevention, treatment or cure of cancer in humans.
Our business is also currently focused on advancing the clinical program underway for the
development of NV-196 and NV-143.
Licence Option deed
Under a licence option deed, Novogen granted us an exclusive first right to accept and an exclusive
last right to match any proposed dealing by Novogen with its intellectual property rights in other
synthetic compounds developed by Novogen that have known or potential anti-cancer applications in
all forms, other than topical applications.
Services
Pursuant to a services agreement, Novogen provides services reasonably required by us relating to
the development and commercialization of phenoxodiol, NV-196, NV-143, or other option compounds in
relation to which we have exercised our rights under the licence option deed. We do not currently
intend to directly employ any staff and are reliant upon Novogen for the provision of resources to
conduct our business.
Manufacturing
Under a manufacturing licence and supply agreement, we have granted Novogen a sublicence to
manufacture and supply phenoxodiol to us in its primary manufactured form for both the OVATURE
clinical program and phenoxodiols ultimate commercial use. Novogen has taken the
strategic decision not to manufacture commercial 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. We have contracts with third parties to validate the
developed scalable manufacturing method to ensure that sufficient quantities of phenoxodiol can be
manufactured in compliance with cGMP (Current Good Manufacturing Practices) and to complete the
analytical and stability work necessary for a New Drug Application (NDA) submission. An NDA will
be submitted if the Phase III study is successful, and approval of the NDA is required to market
phenoxodiol. We will need to arrange similar contracts in the future to secure the supply of NV-196
and NV-143.
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Research and Development
The objective of our research and development program is the generation of data sufficient to
achieve regulatory approval of phenoxodiol, NV-196 and NV-143 in one or more dosage forms in major
markets such as the United States, and/or to allow us to enter into a commercial relationship with
another party. The data are generated by our clinical trial programs.
The key aspects of this program are to provide more complete characterization of the following:
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the relevant molecular targets of action of phenoxodiol, NV-196 and NV-143; |
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the relative therapeutic benefits and indications of phenoxodiol, NV-196 and NV-143 as a
monotherapy or as part of combinational therapy with other chemotoxics; |
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the most appropriate cancer targets for phenoxodiol, NV-196 and NV-143; and |
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the relative therapeutic indications of different dosage forms of phenoxodiol, NV-196
and NV-143. |
Research expenses were $5.761 million for the year ended June 30, 2007, $3.427 million for the year
ended June 30, 2006 and $2.279 million for the year ended June 30, 2005.
Regulation
U.S. Regulatory Requirements
The U.S. Food and Drug Administration, or FDA, and comparable regulatory agencies in other
countries, regulate and impose substantial requirements upon the research, development,
pre-clinical and clinical testing, labeling, manufacture, quality control, storage, approval,
advertising, promotion, marketing, distribution and export of pharmaceutical products including
biologics, as well as significant reporting and record-keeping obligations. State governments may
also impose obligations in these areas.
In the United States, pharmaceutical products are regulated by the FDA under the Federal Food,
Drug, and Cosmetic Act or FDCA and other laws including in the case of biologics, the Public Health
Service Act. We believe, but cannot be certain, that our products will be regulated as drugs by the
FDA. The process required by the FDA before drugs may be marketed in the United States generally
involves the following:
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pre-clinical laboratory evaluations, including formulation and stability testing, and
animal tests performed under the FDAs Good Laboratory Practices regulations to assess
potential safety and effectiveness; |
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submission and approval of an Investigation New Drug, or IND, application, including
results of pre-clinical tests and protocols for clinical tests, which must become effective
before clinical trials may begin in the United States; |
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obtaining approval of Institutional Review Boards or IRBs to administer the products to
human subjects in clinical trials; |
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adequate and well-controlled human clinical trials to establish the safety and efficacy
of the product for the products intended use; |
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development of manufacturing processes which conform to FDA current Good Manufacturing
Practices, or cGMPs, as confirmed by FDA inspection; |
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submission of pre-clinical and clinical test results, and chemistry, manufacture and
control information on the product to the FDA in a New Drug Approval Application, or NDA;
and |
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FDA review and approval of an NDA, prior to any commercial sale or shipment of a
product. |
The testing and approval process requires substantial time, effort, and financial resources, and we
cannot be certain that any approval will be granted on a timely basis, if at all.
The results of the pre-clinical tests, together with initial specified manufacturing information,
the proposed clinical trial protocol, and information about the participating investigators are
submitted to the FDA as part of an IND, which must become effective before we may begin human
clinical trials in the U.S. Additionally, an independent IRB must review and approve each study
protocol and oversee conduct of the trial. An IND becomes effective 30 days after receipt by the
FDA, unless the FDA, within the 30-day period, raises concerns or questions about the conduct of
the trials as outlined in the IND and imposes a clinical hold. If the FDA imposes a clinical hold,
the IND sponsor must resolve the FDAs concerns before clinical trials can begin. Pre-clinical
tests and studies can take several years to complete, and there is no guarantee that an IND we
submit based on such tests and studies will become effective within any specific time period, if at
all.
Human clinical trials are typically conducted in three sequential phases that may overlap.
Phase I: The drug is initially introduced into healthy human subjects or patients and tested for
safety and dosage tolerance. Absorption, metabolism, distribution, and excretion testing is
generally performed at this stage.
Phase II: The drug is studied in controlled, exploratory therapeutic trials in a
limited number of subjects with the disease or medical condition for which the new drug is intended
to be used in order to identify possible adverse effects and safety risks, to determine the
preliminary or potential efficacy of the product for specific targeted diseases or medical
conditions, and to determine dosage tolerance and the optimal effective dose.
Phase III: When Phase II studies demonstrate that a specific dosage range of the drug is likely
to be effective and the drug has an acceptable safety profile, controlled, large-scale therapeutic
Phase III trials are undertaken at multiple study sites to demonstrate clinical efficacy and to
further test for safety in an expanded patient population.
We cannot be certain that we will successfully complete Phase I, Phase II, or Phase III testing of
our products within any specific time period, if at all. Furthermore the FDA, the IRB or we may
suspend or terminate clinical trials at any time on various grounds, including a finding that the
subjects or
patients are being exposed to an unacceptable health risk.
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Results of pre-clinical studies and clinical trials, as well as detailed information about the
manufacturing process, quality control methods, and product composition, among other things, are
submitted to the FDA as part of an NDA seeking approval to market and commercially distribute the
product on the basis of a determination that the product is safe and effective for its intended
use. Before approving an NDA, the FDA will inspect the facilities at which the product is
manufactured and will not approve the product unless cGMP compliance is satisfactory. If applicable
regulatory criteria are not satisfied, the FDA may deny the NDA or require additional testing or
information. As a condition of approval, the FDA also may require post-marketing testing or
surveillance to monitor the products safety or efficacy. Even after an NDA is approved, the FDA
may impose additional obligations or restrictions (such as labeling changes), or even suspend or
withdraw a product approval on the basis of data that arise after the product reaches the market,
or if compliance with regulatory standards is not maintained. We cannot be certain that any NDA we
submit will be approved by the FDA on a timely basis, if at all. Also, any such approval may limit
the indicated uses for which the product may be marketed. Any refusal to approve, delay in
approval, suspension or withdrawal of approval, or restrictions on indicated uses could have a
material adverse impact on our business prospects.
Each NDA must be accompanied by a user fee, pursuant to the requirements of the Prescription Drug
User Fee Act, or PDUFA, and its amendments. According to the FDAs fee schedule, effective on
October 1, 2006 for the fiscal year 2007, the user fee for an application requiring clinical data,
such as an NDA, is $896,200. The FDA adjusts the PDUFA user fees on an annual basis. PDUFA also
imposes an annual product fee for prescription drugs and biologics ($49,750), and an annual
establishment fee ($313,100) on facilities used to manufacture prescription drugs and biologics. A
written request can be submitted for a waiver for the application fee for the first human drug
application that is filed by a small business, but there are no waivers for product or
establishment fees. We are not at the stage of development with our products where we are subject
to these fees, but they are significant expenditures that may be incurred in the future and must be
paid at the time of application submissions to FDA.
Satisfaction of FDA requirements typically takes several years. The actual time required varies
substantially, based upon the type, complexity, and novelty of the pharmaceutical product, among
other things. Government regulation imposes costly and time-consuming requirements and restrictions
throughout the product life cycle and may delay product marketing for a considerable period of
time, limit product marketing, or prevent marketing altogether. Success in pre-clinical or early
stage clinical trials does not ensure success in later stage clinical trials. Data obtained from
pre-clinical and clinical activities are not always conclusive and may be susceptible to varying
interpretations that could delay, limit, or prevent marketing approval. Even if a product receives
marketing approval, the approval is limited to specific clinical indications. Further, even after
marketing approval is obtained, the discovery of previously unknown problems with a product may
result in restrictions on the product or even complete withdrawal of the product from the market.
After product approval, there are continuing significant regulatory requirements imposed by the
FDA, including record-keeping requirements, obligations to report adverse side effects in patients
using the products, and restrictions on advertising and promotional activities. Quality control and
manufacturing procedures must continue to conform to cGMPs, and the FDA periodically inspects
facilities to assess cGMP compliance. Additionally, post-approval changes in ingredient
composition, manufacturing processes or facilities, product labeling, or other areas may require
submission of an NDA Supplement to the FDA for review and approval. New indications will require
additional clinical tests
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and submission of an NDA Supplement. Failure to comply with FDA regulatory requirements may result in
an enforcement action by the FDA, including Warning Letters, product recalls, suspension or
revocation of product approval, seizure of product to prevent distribution, impositions of
injunctions prohibiting product manufacture or distribution, and civil and criminal penalties.
Maintaining compliance is costly and time-consuming. We cannot be certain that we, or our present
or future suppliers or third-party manufacturers, will be able to comply with all FDA regulatory
requirements, and potential consequences of noncompliance could have a material adverse impact on
our business prospects.
The FDAs policies may change, and additional governmental regulations may be enacted that could
delay, limit, or prevent regulatory approval of our products or affect our ability to manufacture,
market, or distribute our products after approval. Moreover, increased attention to the containment
of healthcare costs in the United States and in foreign markets could result in new government
regulations that could have a material adverse effect on our business. Our failure to obtain
coverage, an adequate level of reimbursement, or acceptable prices for our future products could
diminish any revenues we may be able to generate. Our ability to commercialize future products will
depend in part on the extent to which coverage and reimbursement for the products will be available
from government and health administration authorities, private health insurers, and other
third-party payers. European Union and U.S. government and other third-party payers increasingly
are attempting to contain healthcare costs by consideration of new laws and regulations limiting
both coverage and the level of reimbursement for new drugs. We cannot predict the likelihood,
nature or extent of adverse governmental regulation that might arise from future legislative or
administrative action, either in the United States or abroad.
Our activities also may be subject to state laws and regulations that affect our ability to develop
and sell our products. We are also subject to numerous federal, state, and local laws relating to
such matters as safe working conditions, clinical, laboratory, and manufacturing practices,
environmental protection, fire hazard control, and disposal of hazardous or potentially hazardous
substances. We may incur significant costs to comply with such laws and regulations now or in the
future, and the failure to comply may have a material adverse impact on our business prospects.
The FDCA includes provisions designed to facilitate and expedite the development and review of
drugs and biological products intended for treatment of serious or life-threatening conditions that
demonstrate the potential to address unmet medical needs for such conditions. These provisions set
forth a procedure for designation of a drug as a fast track product. The fast track designation
applies to the combination of the product and specific indication for which it is being studied. A
product designated as fast track is ordinarily eligible for additional programs for expediting
development and review, but products that are not in fast track drug development programs may also
be able to take advantage of these programs. These programs include priority review of NDAs and
accelerated approval. Drug approval under the accelerated approval regulations may be based on
evidence of clinical effect on a surrogate endpoint that is reasonably likely to predict clinical
benefit. A postmarketing clinical study will be required to verify clinical benefit, and other
restrictions to assure safe use may be imposed.
Under the Drug Price Competition and Patent Term Restoration Act of 1984 (the Patent Act), a
sponsor may obtain marketing exclusivity for a period of time following FDA approval of certain
drug applications, regardless of patent status, if the drug is a new chemical entity or if new
clinical studies were required to support the marketing application for the drug. This marketing
exclusivity prevents a third party from obtaining FDA approval for an identical or nearly identical
drug under an Abbreviated New Drug Application (ANDA) or a 505(b)(2) New
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Drug Application. The
statutealso allows a patent owner to obtain an extension of applicable patent terms for a period equal to
one-half the period of time elapsed between the filing of an IND and the filing of the
corresponding NDA plus the period of time between the filing of the NDA and FDA approval, with a
five year maximum patent extension. We cannot be certain that Novogen will be able to take
advantage of either the patent term extension or marketing exclusivity provisions of these laws.
The Best Pharmaceuticals for Children Act, signed into law on January 4, 2002, provides an
additional six months of marketing exclusivity for new or marketed drugs, for which specific
pediatric studies were conducted at the written request of the FDA. On December 3, 2003, the
Pediatric Research Equity Act was signed into law, authorizing the FDA to require pediatric studies
for drugs and biological products to ensure the drugs or products safety and effectiveness in
children. This Act required that NDAs or supplements to NDAs contain data assessing the safety and
effectiveness for the claimed indication in all relevant pediatric subpopulations. Dosing and
administration must be supported for each pediatric subpopulation for which the drug is safe and
effective. The FDA may grant deferrals for submission of data, or full or partial waivers.
Australian Regulatory Requirements
The Therapeutic Goods Act 1989, or 1989 Act, sets out the legal requirements for the import,
export, manufacture and supply of pharmaceutical products in Australia. The 1989 Act requires that
all pharmaceutical products to be imported into, supplied in, manufactured in or exported from
Australia be included in the Australian Register of Therapeutic Goods, or ARTG, unless specifically
exempted under the Act.
In order to ensure that a product can be included in the ARTG, a sponsoring company must make an
application to the Therapeutic Goods Administration, or TGA. The application usually consists of a
form accompanied by data (based on the European Union requirements) to support the quality, safety
and efficacy of the drug and payment of a fee. Application details are available on the TGA
website http://www.tga.gov.au.
The first phase of evaluation, known as the Application Entry Process, is usually a short period
during which an application is assessed on an administrative level to ensure that it complies with
the basic guidelines. The TGA must decide within at least 40 working days whether it will accept
the application for evaluation.
Once an application is accepted for evaluation, aspects of the data provided are allocated to
evaluators within the different relevant sections, who prepare evaluation reports. Following
evaluation, the chemistry and quality control aspects of a product may be referred to a
sub-committee of the Australian Drug and Evaluation Committee, or ADEC, to review the relevant
evaluation reports. The evaluation reports (along with any resolutions of the ADEC sub-committee)
are then sent to the sponsoring company who then has the opportunity to comment on the views
expressed within the evaluation report, provide corrections and to submit supplementary data to
address any issues raised in the evaluation reports.
Once the evaluations are complete, the TGA prepares a summary document on the key issues on which
advice will be sought from the ADEC. This summary is sent to the sponsoring company which is able
to submit a response to the ADEC dealing with issues raised in the summary and those not previously
addressed in the evaluation report. The ADEC provides independent advice on the quality,
risk-benefit, effectiveness and access of the drug and conduct medical and scientific evaluations
of the application. The ADECs resolutions are provided to the sponsoring company after 5 working
days after the ADEC meeting.
The TGA takes into account the advice of the ADEC in reaching a decision to approve or reject a
product. Any approval for registration on the ARTG may have conditions associated with it.
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From the time that the TGA accepts the initial application for evaluation, the TGA must complete
the evaluation and make a decision on the registration of the product within at least 255 working
days. The TGA also has a system of priority evaluation for products that meet certain criteria,
including where the product is a new chemical entity that it is not otherwise available on the
market as an approved product, and is for the treatment of a serious, life-threatening illness for
which other therapies are either ineffective or not available.
European Union Regulatory Requirements
Outside the United States, our ability to market our products will also be contingent upon
receiving marketing authorizations from the appropriate regulatory authorities and compliance with
applicable post-approval regulatory requirements. Although the specific requirements and
restrictions vary from country to country, as a general matter, foreign regulatory systems include
risks similar to those associated with FDA regulation, described above. Under EU regulatory
systems, marketing authorizations may be submitted either under a centralized or a national
procedure. Under the centralized procedure, a single application to the European Medicines Agency
(EMEA) leads to an approval granted by the European Commission which permits the marketing of the
product throughout the EU. The centralized procedure is mandatory for certain classes of medicinal
products, but optional for others. For example, all medicinal products developed by certain
biotechnological means, and those developed for cancer and other specified diseases and disorders,
must be authorized via the centralized procedure. We assume that the centralized procedure will
apply to our products that are developed by means of a biotechnology process. The national
procedure is used for products that are not required to be authorized by the centralized procedure.
Under the national procedure, an application for a marketing authorization is submitted to the
competent authority of one member state of the EU. The holders of a national marketing
authorization may submit further applications to the competent authorities of the remaining member
states via either the decentralized or mutual recognition procedure. The decentralized procedure
enables applicants to submit an identical application to the competent authorities of all member
states where approval is sought at the same time as the first application, while under the mutual
recognition procedure, products are authorized initially in one member state, and other member
states where approval is sought are then requested to recognize the original authorization based
upon an assessment report prepared by the original authorizing competent authority. Both the
decentralized and mutual recognition procedures should take no longer than 90 days, but if one
member state makes an objection, which under the legislation can only be based on a possible risk
to human health, the application will be automatically referred to the Committee for Medicinal
Products for Human Use (CHMP) of the EMEA. If a referral for arbitration is made, the procedure is
suspended. However, member states that have already approved the application may, at the request of
the applicant, authorize the product in question without waiting for the result of the arbitration.
Such authorizations will be without prejudice to the outcome of the arbitration. For all other
concerned member states, the opinion of the CHMP, which is binding, could support or reject the
objection or alternatively could reach a compromise position acceptable to all EU countries
concerned. The arbitration procedure may take an additional year before a final decision is reached
and may require the delivery of additional data.
As with FDA approval we may not be able to secure regulatory approvals in Europe in a timely
manner, if at all. Additionally, as in the United States, post-approval regulatory requirements,
such as those regarding product manufacture, marketing, or distribution, would apply to any product
that is approved in Europe, and failure to comply with such obligations could have a material
adverse effect on our ability to successfully commercialize any product.
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The conduct of clinical trials in the European Union is governed by the European Clinical Trials
Directive (2001/20/EC), which was implemented in May 2004. This Directive governs how regulatory
bodies in member states control clinical trials. No clinical trial may be started without a
clinical trial authorization granted by the national competent authority and favorable ethics
approval.
Accordingly, there is a marked degree of change and uncertainty both in the regulation of clinical
trials and in respect of marketing authorizations which face us for our products in Europe.
Government Funding
Novogen received financial support for the phenoxodiol drug program from the Australian government
under what is known as the START Program. The START Program is a merit-based program designed to
encourage and assist Australian companies to undertake research and development and
commercialization through a range of grants and loans. The START Program is administered by the
Industry Research and Development, or IR&D Board. The IR&D Board is made up of private sector and
academic members with expertise and experience in research and development and commercialization.
In 1998, the Australian government agreed to provide A$2.7 million (approximately U.S. $1.8
million) to Novogen, enabling it to expedite phenoxodiol into clinical trials, provided that the
grant money was matched by an equal expenditure by Novogen. The START grant was awarded after the
governments review of the pertinent research results, the intellectual property driving the
program, and the likelihood and potential for commercial success of the drug.
The terms of the grant require Novogen to obtain the consent of the Australian government to deal
with the intellectual property rights which have arisen through the program conducted to date.
Novogen has obtained the consent of the Australian government to the grant of the licence to us and
to the other arrangements between us and Novogen concerning the development and commercialization
of phenoxodiol.
Under the START Program, Novogen must meet certain project development and commercialization
obligations. Novogen has met the project development obligations and has received final payment
thereon. Novogen believes that it is currently in compliance with its commercialization schedule
and that it has fulfilled all of its obligations under the terms of the START Program and expects
to continue to do so in the future. For additional information on the consequences to us in the
event Novogen fails to comply with its obligations under the START Program, see the Intellectual
Property and Risk Factors sections of this annual report.
Employees
We do not have any employees. Novogen provides us with staff and other financial and administrative
services under our services agreement with Novogen.
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Item 1A. Risk Factors
In addition to the other information in this Annual Report the following risk factors should be
considered carefully in evaluating us and our business.
Risks Related to Our Business
We will need additional funds to complete the OVATURE Phase III clinical trial for phenoxodiol and
to progress the clinical trial program for NV-196 and NV-143. The actual amount of funds we will
need will be determined by a number of factors, some of which are beyond our control.
We will need additional funds to complete the OVATURE Phase III clinical trial for phenoxodiol and
to progress the clinical trial program for NV-196 and NV-143. The actual amount of funds that we
will need to complete these projects will be determined by a number of factors, some of which are
beyond our control. These factors may include the following:
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the number of sites included in the trials; |
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the length of time required to enroll suitable patients; |
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the number of patients that participate in the trials and the rate that they are recruited; |
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the number of treatment cycles patients complete while they are enrolled in the trials; and |
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the efficacy and safety profile of the product. |
If we are unable to obtain additional funds on favourable terms we may be required to cease or
reduce our operations. Also, if we raise more funds by selling additional shares of our common
stock or securities convertible into or exercisable for shares of our common stock, the ownership
interests of our common stockholders will be diluted.
We may not complete our OVATURE Phase III trial on schedule, or at all, or it may be conducted
improperly, which will delay or preclude FDA marketing approval and increase costs.
The completion of our OVATURE clinical trial may be delayed or terminated for many reasons,
including, but not limited to, if:
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we are unable to identify and contract clinical trial sites and clinical investigators
at the rate we expect or those sites are delayed from commencing patient recruitment due
to regulatory hospital ethics committee approvals or those investigators do not perform to
our anticipated patient recruitment schedule or comply with the clinical trial protocol; |
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patients are not available to enrol at the rate we currently expect, or that trial
sites are unable to recruit their target patient numbers due to the strict inclusion
criteria of the OVATURE protocol which may reduce the patient pool available to
participate in the trial; |
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subjects experience an unacceptable rate or severity of adverse side effects; |
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third party clinical investigators do not conduct the trial in compliance with Good
Clinical Practice and regulatory requirements, or other third parties do not perform data
collection and analysis in a timely or accurate manner; |
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one or more IRB suspends or terminates the trial at an
investigational site, precludes enrolment of additional subjects, or withdraws its approval of the trial; or |
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one or more of our clinical investigators withdraws from our trials or deviates from
our approved protocol. |
Our costs will increase if we have material delays in our OVATURE pivotal trial, or if we are
required to modify, suspend, terminate or repeat it.
If the data from our OVATURE Phase III clinical trial do not demonstrate the safety and
effectiveness of phenoxodiol to the FDAs satisfaction, we will not receive FDA approval to market
phenoxodiol in the United States.
In 2004, the FDA granted phenoxodiol fast track status for patients with recurrent late stage
ovarian cancer that is resistant or refractory to platins and taxanes. More recently we completed
an SPA where the FDA reviewed and agreed with the design of a Phase III study of phenoxodiol in
combination with carboplatin in women with platinum-resistant ovarian cancer (ovarian cancer that
does not respond to platinum based anti-cancer agents such as cisplatin). If the FDA concludes,
using agreed clinical endpoints, that the data from our pivotal clinical trial have failed to
demonstrate the safety and effectiveness of phenoxodiol to the satisfaction of the FDA, we will not
receive FDA approval to market phenoxodiol in the United States. We cannot assure you that the
results of our Phase III trial will be successful.
The third-party manufacturers that we rely upon for the production of phenoxodiol for our
clinical trials, and for future commercial quantities, may not be in compliance with FDA regulatory
requirements.
The conduct of our clinical trials and approval of our marketing application for phenoxodiol
may be delayed or adversely affected if the third-party manufacturers that we rely upon for the
production of phenoxodiol fail to comply with FDAs regulatory requirements for cGMPs. FDA requires
drug manufacturers to establish and maintain quality control procedures for manufacturing,
processing, and holding drugs and investigational products, and products must be manufactured in
accordance with defined specifications. The failure of contract manufacturers to supply
investigational product in compliance with the defined specifications for phenoxodiol may delay the
completion of our clinical trials. As part of the pre-market approval process, the manufacturer
will be inspected by FDA to ensure compliance with cGMPs. The failure of contract manufacturers to
comply with applicable regulations may result in a delay or prevent approval of our marketing
application.
If we do not receive marketing approval, our commercial prospects for phenoxodiol will be impaired.
Clinical trials have a high risk of failure. A number of companies in the pharmaceutical industry,
including biotechnology companies, have suffered significant setbacks in advanced clinical trials,
even after achieving promising results in earlier trials. If our clinical trials are unsuccessful,
our prospects for commercializing phenoxodiol will be impaired and we may be required to cease or
reduce our operations. This will have a significant impact on our share price.
Final approval by regulatory authorities of our drug candidates for commercial use may be delayed,
limited or prevented, any of which would adversely affect our ability to generate operating
revenues.
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Any of the following factors may serve to delay, limit or prevent the final approval by regulatory
authorities of our drug candidates for commercial use:
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NV-196 and NV-143 are in the early stages of clinical development and we will need to
conduct significant clinical testing to prove safety and efficacy before applications for
marketing can be filed with the FDA, or with the regulatory authorities of other countries; |
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data obtained from pre-clinical and clinical tests can be interpreted in different ways,
which could delay, limit or prevent regulatory approval; |
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development and testing of product formulation, including identification of suitable
excipients, or chemical additives intended to facilitate delivery of our drug candidates; |
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it may take us many years to complete the testing of other drug candidates, and failure
can occur at any stage of this process; and |
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negative or inconclusive results or adverse medical events during a clinical trial could
cause us to delay or terminate our development efforts. |
While we have not encountered any material delays or adverse events from the factors described
above to date, we cannot assure you that such delays or adverse events will not be encountered in
the future.
We have a limited operating history, and we are likely to incur operating losses for the
foreseeable future.
You should consider our prospects in light of the risks and difficulties frequently encountered by
early stage and developmental companies. Although we were incorporated in December 2000, we have
only been in operation since May 2002. We have incurred net losses of $39,321,000 since our
inception, including net losses of $13,820,000, $7,386,000 and $6,421,000 for the years ended June
30, 2007, 2006 and 2005, respectively. We anticipate that we will incur operating losses and
negative operating cash flow for the foreseeable future. We have not yet commercialized any drug
candidates and cannot be sure that we will ever be able to do so, or that we may ever become
profitable. We have expanded our clinical trials significantly with the commencement of the OVATURE
trial, which will result in increasing losses and we may continue to incur substantial losses in
future even if we begin to generate revenues from the distribution and sale of phenoxodiol.
We may not be able to establish the strategic partnerships necessary to develop, market and
distribute phenoxodiol.
A key part of our business plan is to establish relationships with strategic partners. We must
successfully contract with third parties to package, market and distribute phenoxodiol. We have not
yet established any strategic partnerships. Potential partners may not wish to enter into
agreements with us due to Novogens current equity position as our majority stockholder or our
contractual relationships with Novogen. Similarly, potential partners may be discouraged by our
limited operating history. Additionally, our relative attractiveness to potential partners and
consequently, our ability to negotiate acceptable terms in any partnership agreement will be
affected by the results of our clinical program. For example, if phenoxodiol is shown to have high
efficacy against a broad range of cancers we may generate greater interest from potential partners
than if phenoxodiol was demonstrated to be less effective or applicable to a narrower range of
cancers. There is no assurance that we
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will be
able to negotiate commercially acceptable licensing or other agreements for the future exploitation of
phenoxodiol, including the continued clinical development, manufacture or marketing of phenoxodiol.
If we are unable to successfully contract for these services, or if arrangements for these services
are terminated, we may have to delay our commercialization program for phenoxodiol which will
adversely affect our ability to generate operating revenues.
We have not yet submitted an IND for NV-196 or NV-143 product candidates with the FDA and until an
IND becomes effective, we will not be able to perform human clinical trials in the United States.
Although we have conducted two Phase I clinical trials of NV-196 in Australia, we have not yet
submitted an IND to the FDA. NV-143 has not yet commenced clinical trials in humans. Until an IND
becomes effective, we will not be able to perform human clinical trials of our NV-196 or NV-143
product candidates in the United States. Approval to begin clinical testing in the United States
requires submission of: (i) adequate information on the safety and manufacturing of NV-196 or
NV-143 to assure the proper identification quality, purity and strength of the investigational
product, (ii) summary of pharmacological and toxicological effects, pharmacokinetics (how the drug
is absorbed and metabolised) and biological disposition in animals, (iii) the proposed protocol for
any planned clinical study, and (iv) a brief description of the overall plan for investigating the
product. Although we intend to prepare an IND to be submitted to the FDA, we do not know whether or
when the IND will become effective.
Our commercial opportunity will be reduced or eliminated if competitors develop and market products
that are more effective, have fewer side effects or are less expensive than phenoxodiol.
The development of phenoxodiol and other drug candidates is highly competitive. A number of other
companies have products or drug candidates in various stages of pre-clinical or clinical
development that are intended for the same therapeutic indications for which phenoxodiol is being
developed. Some of these potential competing drugs are further advanced in development than
phenoxodiol and may be commercialized sooner. Even if we are successful in developing effective
drugs, phenoxodiol may not compete successfully with products produced by our competitors.
Our competitors include pharmaceutical companies and biotechnology companies, as well as
universities and public and private research institutions. In addition, companies active in
different but related fields represent substantial competition for us. Many of our competitors
developing oncology drugs have significantly greater capital resources, larger research and
development staffs and facilities and greater experience in drug development, regulation,
manufacturing and marketing than us. These organizations also compete with Novogen, our services
provider, to recruit qualified personnel, and with us to attract partners for joint ventures and to
license technologies that are competitive with ours. As a result, our competitors may be able to
more easily develop technologies and products that would render our technologies or our drug
candidates obsolete or non-competitive.
We have no direct control over the costs of manufacturing phenoxodiol, NV-196 or NV-143 and
increases in these costs would increase the costs of conducting clinical trials and could adversely
affect future profitability if these costs increase significantly.
We do not intend to manufacture phenoxodiol or NV-196 or NV-143 ourselves and we will be relying on
third parties for our supplies of phenoxodiol both for clinical trials and for commercial
quantities in the future. Novogen, has taken the strategic decision not to manufacture on a large
scale APIs for cancer drugs, including phenoxodiol, as these can be more economically supplied by
third parties with particular
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expertise
in this area. The contract facilities that have been identified are
registered with the FDA, have a track record of large scale APIs manufacture and have already invested in capital
and equipment. We have completed the novation to Marshall Edwards Pty Limited (MEPL) of contracts
that Novogen had entered into with third parties to validate the developed scalable manufacturing
method to ensure that sufficient quantities of phenoxodiol can be manufactured in compliance with
the FDAs current Good Manufacturing Practices
(cGMP) and to complete the analytical and stability work
necessary for a New Drug Application (NDA) submission for
marketing approval. An NDA will
be submitted if the planned Phase III study is successful, and approval of the NDA is required to
market phenoxodiol. We will need to arrange similar contracts in the future to secure the supply of
NV-196 and NV-143. We have no direct control over the costs of manufacturing our product
candidates. If the costs of manufacturing increase or if the cost of the materials used increases,
these costs will be passed on to us making the cost of conducting clinical trials more expensive.
Increases in manufacturing costs could adversely affect our future profitability if we are unable
to pass all of the increased costs along to our customers.
We may not be able to secure and maintain suitable research institutions to conduct our clinical
trials.
We rely on suitable research institutions, of which there are many, to conduct our clinical trials.
Our reliance upon research institutions, including hospitals and cancer clinics, provides us with
less control over the timing and cost of clinical trials and the ability to recruit patients than
if we had conducted the trials on our own. Further, there is a greater likelihood that disputes may
arise with these research institutions over the ownership of intellectual property discovered
during the clinical trials. If we are unable to reach agreement with suitable research institutions
on acceptable terms, or if any resulting agreement is terminated and we are unable to quickly
replace the applicable research institution with another qualified institution on acceptable terms,
the research could be delayed and we may be unable to complete development, or commercialize
phenoxodiol, NV-196 or NV-143, which will adversely affect our ability to generate operating
revenues.
We face a risk of product liability claims and may not be able to obtain adequate insurance.
Our business exposes us to the risk of product liability claims. This risk is inherent in the
manufacturing, testing and marketing of human therapeutic products. We have product liability
insurance coverage of up to approximately $17.4 million. Although we believe that this amount of
insurance coverage is appropriate for our business at this time, it is subject to deductibles and
coverage limitations, and the market for such insurance is becoming more restrictive. We may not be
able to obtain or maintain adequate protection against potential liabilities. If we are unable to
sufficiently insure against potential product liability claims, we will be exposed to significant
liabilities, which may materially and adversely affect our business development and
commercialization efforts.
Our rights to develop and exploit phenoxodiol and the anti-cancer compounds NV-196 and NV-143 are
subject to the terms and conditions of agreements we have entered into with Novogen, and under
these agreements our rights may be terminated under certain circumstances, some of which may be
beyond our control.
We have licensed the intellectual property in the phenoxodiol technology and the anti-cancer
compounds NV-196 and NV-143 from Novogen. Under the terms of the license agreement for phenoxodiol,
all forms of administering phenoxodiol for the treatment of cancer are licensed to us, excluding
topical applications. Under the terms of the license agreement for NV-196 and NV-143, all forms of
administering drugs containing
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the
anti-cancer compounds NV-196 and NV-143 are licensed to us, excluding topical applications. If we fail to meet our obligations under our license
agreements, the manufacturing license and supply agreement or the services agreement with Novogen,
any or all of these agreements may be terminated by Novogen and we could lose our rights to develop
phenoxodiol or anti-cancer drugs containing NV-196 and NV-143. To date, we have no reason to
believe that we will be unable to satisfy our obligations under these agreements. In addition, each
of these agreements may be terminated immediately by Novogen in the event that we undergo a change
of control without the consent of Novogen. A change of control means a change in control of more
than half the voting rights attaching to the shares of our subsidiary, a change in control of more
than half of the issued shares of our subsidiary (not counting any share which carries no right to
participate beyond a specified amount in the distribution of either profit or capital) or a change
in control of the composition of the board of directors of our subsidiary. Each of these agreements
may also be terminated if we cease for any reason to be able to lawfully carry out all the
transactions required by each respective agreement.
Our license rights are fundamental to our business and therefore a loss of these rights will likely
cause us to cease operations.
The rights granted to us under the license agreements, the manufacturing license and supply
agreement and the license option deed with Novogen are fundamental to our business. The license
agreement for phenoxodiol grants us the right to make, have made, market, distribute, sell, hire or
otherwise dispose of phenoxodiol products in the field of prevention, treatment or cure of cancer
in humans by pharmaceuticals delivered in all forms except topical applications. The license
agreement for NV-196 and NV-143 grants us the right to make, have made, market, distribute, sell,
hire or otherwise dispose of anti-cancer drugs containing the compounds NV-196 and NV-143 in the
field of prevention, treatment or cure of cancer in humans by pharmaceuticals delivered in all
forms except topical applications. Our business purpose is to develop and commercialize cancer
drugs including phenoxodiol and drugs containing the compounds NV-196 and NV-143, which we would be
unable to pursue without the rights granted to us under the license agreements. The license option
deed grants us an exclusive first right to accept and exclusive last right to match any proposed
dealing by Novogen with its intellectual property rights with a third party relating to certain
compounds (other than phenoxodiol) developed by Novogen and its affiliates which have applications
in the field of prevention, treatment or cure of cancer in humans. The license option deed is
important to our business because it allows us to maintain control over the sale by Novogen of
complementary as well as potentially competitive intellectual property rights to third party
competitors. Any loss of the rights under any of these agreements will likely cause us to cease
operations.
The success of our product candidates is largely dependent on Novogens ability to obtain and
maintain patent protection and preserve trade secrets, which cannot be guaranteed.
Patent protection and trade secret protection are important to our business and our future will
depend, in part on our ability and the ability of Novogen to maintain trade secret protection,
obtain patents and operate without infringing the proprietary rights of others both in the United
States and abroad. Litigation or other legal proceedings may be necessary to defend against claims
of infringement, to enforce our patents, or to protect our trade secrets or the trade secrets of
Novogen. Such litigation could result in substantial costs and diversion of our managements
attention. Novogen has not been involved in any opposition re-examination trade secret dispute,
infringement litigation or any other litigation or legal proceedings pertaining to the licensed
patent rights.
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The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and
involve complex legal and factual questions. Novogen has applied for patents in a number of
countries with respect to the use of phenoxodiol for the treatment, prevention or cure of cancer. We have
licensed both issued patents and pending patent applications from Novogen. Novogen has issued
patents in the United States, Australia and Singapore covering the use of phenoxodiol to prevent or
treat skin cancer from ultraviolet damage. Novogen also has patents issued in Australia, Hong Kong,
New Zealand and the United Kingdom related to phenoxodiol for the treatment of a variety of cancers
and has recently received a patent grant in the United States that is also related to phenoxodiol
for the treatment of a variety of cancers.
Novogens applications may not proceed to grant or may be amended to reduce the scope of protection
of any patent granted. The applications and patents may also be opposed or challenged by third
parties. Our commercial success will depend, in part, on the ability of Novogen and our ability to
obtain and maintain effective patent protection for the technologies underlying phenoxodiol and
other compounds, and to successfully defend patent rights in those technologies against third-party
challenges. As patent applications in the United States are maintained in secrecy until published
or issued and as publication of discoveries in the scientific or patent literature often lag behind
the actual discoveries, we cannot be certain that Novogen was the first to make the inventions
covered by its pending patent applications or issued patents or that it was the first to file
patent applications for such inventions. Additionally, the breadth of claims allowed in
biotechnology and pharmaceutical patents or their enforceability cannot be predicted. We cannot be
sure that any additional patents will issue from any of Novogens patent applications or, should
any patents issue, that we will be provided with adequate protection against potentially
competitive products. Furthermore, we cannot be sure that should patents issue, they will be of
commercial value to us, or that private parties, including competitors, will not successfully
challenge our patents or circumvent our patent position in the United States or abroad.
Claims by other companies that we infringe their proprietary technology may result in liability for
damages or stop our development and commercialization efforts.
The pharmaceutical industry is highly competitive and patents have been applied for by, and issued
to, other parties relating to products competitive with phenoxodiol. Therefore, phenoxodiol and any
other drug candidates may give rise to claims that they infringe the patents or proprietary rights
of other parties existing now and in the future. Furthermore, to the extent that we or Novogen or
our respective consultants or research collaborators use intellectual property owned by others in
work performed for us or Novogen, disputes may also arise as to the rights in such intellectual
property or in resulting know-how and inventions. An adverse claim could subject us to significant
liabilities to such other parties and/or require disputed rights to be licensed from such other
parties.
We have currently contracted formulation development and manufacturing process development work for
phenoxodiol formulation. This work is being conducted to ensure that there is a robust production
process which meets the expected commercial quantities of phenoxodiol and that dose formulations
are manufactured on a cost effective basis.
This process has identified a number of excipients, or additives to improve drug delivery, that may
be used in the formulations of phenoxodiol. Excipients, among other things, perform the function of
a carrier of the active drug ingredient in the intravenous formulation. Some of these identified
excipients or carriers may be included in third party patents in some countries. We intend to seek
a license if we decide to use a patented excipient in the marketed intravenous product or we may
choose one of those excipients that do not have a license requirement.
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We cannot be sure that any license required under any such patents or proprietary rights would be
made available on terms acceptable to us, if at all. If we do not obtain such licenses, we may
encounter delays in product market introductions, or may find that the development, manufacture or
sale of products requiring such licenses may be precluded. We have not conducted any searches or
made any independent investigations of the existence of any patents or proprietary rights of other
parties.
We may be subject to substantial costs stemming from our defense against third-party intellectual
property infringement claims.
Third parties may assert that we or Novogen are using their proprietary information without
authorization. Third parties may also have or obtain patents and may claim that technologies
licensed to or used by us infringe their patents. If we are required to defend patent infringement
actions brought by third parties, or if we sue to protect our own patent rights, we may be required
to pay substantial litigation costs and managerial attention may be diverted from business
operations even if the outcome is not adverse to us. In addition, any legal action that seeks
damages or an injunction to stop us from carrying on our commercial activities relating to the
affected technologies could subject us to monetary liability and require us or Novogen or any third
party licensors to obtain a license to continue to use the affected technologies. We cannot predict
whether we or Novogen would prevail in any of these types of actions or that any required license
would be made available on commercially acceptable terms or at all.
In the event that Novogen does not comply with its obligations under a grant from the Australian
Government under which phenoxodiol was, in part, developed, our rights to use the intellectual
property relating to phenoxodiol and developed by Novogen may revert back to the Australian
Government.
Novogen developed phenoxodiol in part using funds from the Australian Government under what is
known as the START Program. Under the START Program, Novogen must meet certain project development
and commercialization obligations. Novogen has met the project development obligations and has
received final payment thereon. Novogen believes it is currently in compliance with its
commercialization schedule. Although Novogen believes that it has complied with its obligations
under the START Program, if the Australian Government disagrees or if Novogen undergoes a change of
control without the prior consent of the Australian Government, the Australian Government has a
right to demand that intellectual property created during the course of the project funded by the
grant be vested back in the Australian Government or demand repayment of the funds paid to Novogen
under the program. The Australian Government may then license the intellectual property rights
related to phenoxodiol to other parties and may demand other intellectual property rights from
Novogen. Any such reclamation by the Australian Government could preclude our use of Novogens
intellectual property in the development and commercialization of phenoxodiol and we may have to
compete with other companies to whom the Australian Government may license the intellectual
property.
The enforcement of civil liabilities against our officers and directors may be difficult.
Most of our officers and directors are residents of jurisdictions outside the United States. As a
result it may be difficult for you to effect service of process within the United States upon all
our officers and directors or to enforce judgments obtained against all our officers and directors
or us in United States courts.
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Our results are affected by fluctuations in currency exchange rates.
Much of our expenditures and potential revenue will be spent or derived outside of the United
States. As a result, fluctuations between the United States dollar and the currencies of the
countries in which we operate may increase our costs or reduce our potential revenue. At present,
we do not engage in hedging transactions to protect against uncertainty in future exchange rates
between particular foreign currencies and the U.S. dollar.
We are authorized to issue a class of blank check preferred stock, which could adversely affect the
holders of our common stock.
Our restated certificate of incorporation allows us to issue a class of blank check preferred stock
with rights potentially senior to those of our common stock without any further vote or action by
the holders of our common stock. The issuance of preferred stock could decrease the amount of
earnings and assets available for distribution to the holders of our common stock or could
adversely affect the rights and powers including voting rights, of such holders. In certain
circumstances such issuance could have the effect of decreasing the market price of our shares, or
making a change in control of us more difficult.
Risks Related to Our Relationship with Novogen
As our majority stockholder, Novogen has the ability to determine the outcome of all matters
submitted to our stockholders for approval and Novogens interests may conflict with ours or our
other stockholders interests.
Novogen beneficially owns approximately 71.9% (as at the date of this report) of our outstanding
shares of common stock. As a result, Novogen will have the ability to effectively determine the
outcome of all matters submitted to our stockholders for approval, including the election and
removal of directors and any merger, consolidation or sale of all or substantially all of our
assets.
Novogen will have the ability to effectively control our management and affairs. Novogens
interests may not always be the same as that of our other stockholders. In addition this
concentration of ownership may harm the market price of our shares by:
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impeding a merger, consolidation, takeover or other business combination involving us; |
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discouraging a potential acquirer from making a tender, offer or otherwise attempting to
obtain control of us; or |
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selling us to a third party. |
Three of our directors and our secretary and chief financial officer are officers and/or directors
of Novogen and other Novogen subsidiaries, which may create a conflict of interest as well as
prevent them from devoting their full attention to us.
Three of our board members currently serve as board members of Novogen. Simultaneous service as a
Novogen director or officer could create, or appear to create, a conflict of interest when such
directors are presented with decisions that could have different implications for us and Novogen.
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Mr. Philip Johnston is the chairman of Novogen Limited, Mr. Christopher Naughton is the managing
director of Novogen Limited and Professor Paul John Nestel is a director of Novogen Limited. Mr.
David Seaton is chief financial officer of Novogen. The responsibilities of Messrs. Johnston,
Naughton and Seaton and Professor Nestel to Novogen could prevent them from devoting their full
attention to us, which could be harmful to the development of our business.
We depend on a number of key personnel whose services are provided by Novogen under our services
agreement. If we are not able to procure these services in the future, the strategic direction of
the clinical development program would be disrupted, causing a delay in our commercialization
program.
We currently rely on Professor Alan Husband, Novogen Research Director, and Mr. Christopher
Naughton, our President and Chief Executive Officer, to provide the strategic direction for the
clinical development of phenoxodiol. If we are unable to secure the ongoing services of these key
personnel, the commercialization program for phenoxodiol will be disrupted and will cause delays in
obtaining marketing approval. Novogen has entered into employment agreements with Professor Husband
and Mr. Naughton.
Novogen can compete with us.
We have no contract, arrangement or understanding with Novogen to preclude it from developing a
product which may be competitive with phenoxodiol, NV-196 or NV-143 or to use these compounds for
any uses other than anti-cancer applications. Novogen has reserved the intellectual property rights
and know-how rights relating to topical applications of these compounds even in the field of
cancer. There can be no assurance that Novogen or its subsidiaries will not pursue alternative
technologies or product candidates as a means of developing treatments for the conditions targeted
by phenoxodiol or any other product candidate which we seek to exploit.
We are dependent on Novogen for our personnel.
We have no employees. We rely on Novogen to provide or procure the provision of staff and other
financial and administrative services under our services agreement with Novogen. We believe Novogen
has fully complied with the terms of our services agreement. To successfully develop our drug
candidates, we will require ongoing access to the personnel who have, to date, been responsible for
the development of our drug candidates. The services agreement does not specify a minimum amount of
time that Novogen employees must devote to our operations. If we are unable to secure or if we lose
the services of these personnel, the ability to develop our drug candidates could be materially
impaired. Moreover, if our business experiences substantial and rapid growth, we may not be able to
secure the services and resources we require from Novogen or from other persons to support that
growth.
Risks Related to Our Common Stock
The trading price of the shares of our common stock could be highly volatile and could decline in
value and we may incur significant costs from class action litigation.
The trading price of our common stock could be highly volatile in response to various factors, many
of which are beyond our control, including:
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developments concerning phenoxodiol and our other drug candidates NV-196 and NV-143; |
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announcements of technological innovations by us or our competitors; |
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new products introduced or announced by us or our competitors; |
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changes in financial estimates by securities analysts; |
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actual or anticipated variations in operating results; |
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expiration or termination of licenses, research contracts or other collaboration agreements; |
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conditions or trends in the regulatory climate and the biotechnology, pharmaceutical and
genomics industries; |
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changes in the market valuations of similar companies; |
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the liquidity of any market for our securities; and |
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additional sales by us or Novogen of shares of our common stock. |
In addition, equity markets in general, and the market for biotechnology and life sciences
companies in particular, have experienced substantial price and volume fluctuations that have often
been unrelated or disproportionate to the operating performance of companies traded in those
markets. In addition, changes in economic conditions in the United States, Europe or globally,
could impact upon our ability to grow profitably. Adverse economic changes are outside our control
and may result in material adverse impacts on our business or our results of operations. These
broad market and industry factors may materially affect the market price of our shares of common
stock, regardless of our development and operating performance. In the past, following periods of
volatility in the market price of a companys securities, securities class-action litigation has
often been instituted against that company. Such litigation, if instituted against us, could cause
us to incur substantial costs and divert managements attention and resources.
Future sales of our common stock may depress our stock price and cause stockholders to experience
dilution.
The market price of our common stock could decline as a result of sales of substantial amounts of
our common stock in the public market, or the perception that these sales could occur.
We will have broad discretion over the use of the net proceeds to us from any exercise of
outstanding warrants.
We will have broad discretion to use the net proceeds to us upon any exercise of outstanding
warrants, and you will be relying on the judgment of our board of directors and management
regarding the application of these proceeds. Although we expect to use a substantial portion of the
net proceeds from any exercise of the warrants for general corporate purposes, including potential
payments to Novogen under the terms of the license agreements, potential licensing of other cancer
compounds developed by Novogen under the license option deed and potential expansion of the
clinical trial program for phenoxodiol to include other forms of cancer, we have not allocated
these net proceeds for specific purposes.
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Risks Related to the Private Placement
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 July 11, 2006, we may be obligated to pay the investors of those
securities liquidated damages.
In the event that the registration statement that was declared effective on September 5, 2006
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 investors 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 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 or shares of common stock issuable upon exercise of warrants then held by
each investor per month (pro rated for any period less than a month) until the registration
statement is effective or the investors 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 each investor in the private placement may not exceed more than 10% of
the purchase price paid by such investor for shares of common stock or shares of common stock
issuable upon exercise of warrants 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.
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.
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In connection with the securities subscription agreement we entered into with certain accredited
investors 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.
In the
event that the registration statement is not filed by the required filing date or 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 investors 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 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 registration statement is effective or the
investors 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 each investor in the private placement may not exceed more than 10% of
the purchase price paid by such investor 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.
33
Item 1B. Unresolved Staff Comments
None.
Item 2. Properties
We do not own or lease any property.
Item 3. Legal Proceedings
None.
Item 4. Submission of Matters to a Vote of Security Holders
No matters were submitted to a vote of security holders during the fourth quarter of the fiscal
year covered by this Annual Report on Form 10-K.
34
PART II
Item 5. Market for the Registrants Common Equity, Related Stockholder Matters and Issuer Purchases
of Securities
The following tables set forth for the period indicated the high and low sale prices of our common
stock and warrants as reported by the Nasdaq Global Market and for our common stock as reported by
the Alternative Investment Market of the London Stock Exchange (AIM). The trading price for our
shares of common stock on the AIM are quoted as sterling (£), the lawful currency of the United
Kingdom. On January 17, 2006, we voluntarily cancelled the trading of our common stock on the AIM.
Common Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nasdaq Global Market |
|
AIM Market |
|
|
High |
|
Low |
|
High |
|
Low |
Year Ended June 30, 2006 |
|
$ |
|
$ |
|
£ |
|
£ |
First Quarter |
|
|
7.98 |
|
|
|
5.68 |
|
|
|
4.08 |
|
|
|
3.40 |
|
Second Quarter |
|
|
8.25 |
|
|
|
5.53 |
|
|
|
4.28 |
|
|
|
3.25 |
|
Third Quarter |
|
|
7.29 |
|
|
|
4.36 |
|
|
|
3.80 |
|
|
|
3.20 |
|
Fourth Quarter |
|
|
6.02 |
|
|
|
2.51 |
|
|
|
N/A |
|
|
|
N/A |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
|
3.75 |
|
|
|
2.58 |
|
|
|
N/A |
|
|
|
N/A |
|
Second Quarter |
|
|
3.68 |
|
|
|
2.82 |
|
|
|
N/A |
|
|
|
N/A |
|
Third Quarter |
|
|
4.90 |
|
|
|
3.08 |
|
|
|
N/A |
|
|
|
N/A |
|
Fourth Quarter |
|
|
4.28 |
|
|
|
2.75 |
|
|
|
N/A |
|
|
|
N/A |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants (with December 2006 expiry) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
|
4.01 |
|
|
|
2.55 |
|
|
|
|
|
|
|
|
|
Second Quarter |
|
|
3.25 |
|
|
|
0.68 |
|
|
|
|
|
|
|
|
|
Third Quarter |
|
|
1.99 |
|
|
|
0.50 |
|
|
|
|
|
|
|
|
|
Fourth Quarter |
|
|
0.74 |
|
|
|
0.20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
|
0.30 |
|
|
|
0.02 |
|
|
|
|
|
|
|
|
|
Second Quarter |
|
|
0.29 |
|
|
|
0.01 |
|
|
|
|
|
|
|
|
|
Third Quarter |
|
|
N/A |
|
|
|
N/A |
|
|
|
|
|
|
|
|
|
Fourth Quarter |
|
|
N/A |
|
|
|
N/A |
|
|
|
|
|
|
|
|
|
35
The following table sets forth, for the period indicated, the high, low, average and
period-end noon buying rate for sterling, expressed in dollars per sterling in New York City as
certified for customs purposes by the Federal Reserve Bank of New York.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period Ended |
|
High |
|
Low |
|
Average |
|
Period-End |
Year Ended June 30, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
1.8420 |
|
|
$ |
1.7303 |
|
|
$ |
1.7854 |
|
|
$ |
1.7696 |
|
Second Quarter |
|
$ |
1.7855 |
|
|
$ |
1.7138 |
|
|
$ |
1.7486 |
|
|
$ |
1.7188 |
|
Third Quarter |
|
$ |
1.7885 |
|
|
$ |
1.7256 |
|
|
$ |
1.7532 |
|
|
$ |
1.7393 |
|
Fourth Quarter |
|
$ |
1.8911 |
|
|
$ |
1.7389 |
|
|
$ |
1.8286 |
|
|
$ |
1.8491 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
|
N/A |
|
|
|
N/A |
|
|
|
N/A |
|
|
|
N/A |
|
Second Quarter |
|
|
N/A |
|
|
|
N/A |
|
|
|
N/A |
|
|
|
N/A |
|
Third Quarter |
|
|
N/A |
|
|
|
N/A |
|
|
|
N/A |
|
|
|
N/A |
|
Fourth Quarter |
|
|
N/A |
|
|
|
N/A |
|
|
|
N/A |
|
|
|
N/A |
|
As of August 15, 2007, there were approximately 1,435 stockholders on record of our common
stock.
Dividends
We have never declared or paid any cash dividends on our common stock and do not anticipate paying
any cash dividends in the foreseeable future. We currently intend to retain future earnings, if
any, to fund the expansion and growth of our business. Payments of any future cash dividends will
be at the discretion of our board of directors after taking into account various factors, including
our financial condition, operating results, current and anticipated cash needs, plans for expansion
and other factors that our board of directors deem relevant.
Stock Repurchases
We have not repurchased any shares of common stock during the fourth quarter of the fiscal year
ended June 30, 2007.
36
Equity Compensation
The following table sets forth, as of June 30, 2007 outstanding awards and shares remaining
available for future issuance under our compensation plans under which equity securities are
authorized for issuance.
|
|
|
|
|
|
|
|
|
|
|
|
|
(c) |
|
|
(a) |
|
(b) |
|
Number of securities |
|
|
Number of securities to |
|
Weighted-average |
|
remaining available for |
|
|
be issued upon exercise of |
|
exercise price of |
|
future issuance under |
|
|
outstanding options, |
|
outstanding options, |
|
equity compensation |
Plan Category |
|
warrants and rights |
|
warrants and rights |
|
plans |
Equity compensation
plans approved by
security holders
|
|
Not Applicable
|
|
Not Applicable
|
|
Not Applicable |
|
|
|
|
|
|
|
Equity compensation
plans not approved
by security holders
|
|
None
|
|
Not Applicable
|
|
Indeterminable |
|
|
|
|
|
|
|
Total
|
|
None
|
|
Not Applicable
|
|
Indeterminable |
Our Employee Share Option Plan (the Plan) provides our directors, employees, employees of
our affiliates and certain of our contractors and consultants with the opportunity to participate
in our ownership. To date, no options have been issued under the Plan. The Remuneration Committee,
appointed by the Board of Directors, addresses participation, the number of options offered and any
conditions of exercise. In making these determinations the Remuneration Committee will generally
consider the participants position and record of service to us and our affiliates and potential
contribution to the growth of us and our affiliates. Any other matters tending to indicate the
participants merit may also be considered. Options will be exercisable between two years and five
years after grant, unless otherwise determined by the Remuneration Committee. Options granted will
be exercisable at a price determined by the Remuneration Committee at the time of issue (and will
be subject to adjustment in accordance with the terms of the plan). Other key terms of the Plan
include:
|
|
|
Options will lapse if the participants cease to be engaged by us or our affiliates. The
committee will have the discretion to waive this provision. |
|
|
|
|
The terms of the Plan also provide for adjustments to the rights of an option holder as
a result of a reorganisation of our capital or other corporate event. The holder of an
option is not permitted to participate in any distribution by us or in any rights or other
entitlements issued by us to stockholders in respect of our shares unless the options are
exercised prior to the relevant record; and |
|
|
|
|
All options vest on the occurrence of certain events such as a change of control, as
defined in the Plan. |
The Plan also contains standard provisions dealing with matters such as administration of the Plan,
amendment of the Plan and termination or suspension of the Plan.
37
Stock Performance Graph
The graph set forth below compares the change in our cumulative total stockholder return on our
common stock between December 18, 2003 (the date our common stock commenced public trading) and
June 29, 2007 with the cumulative total return of the NASDAQ Composite Index and the NASDAQ
Biotechnology Index during the same period. This graph assumes the investment of $100 on December
18, 2003 in our common stock and each of the comparison groups and assumes reinvestment of
dividends, if any. We have not paid any dividends on our common stock, and no dividends are
included in the report of our performance.
Stock
Performance Comparison
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12/18/03 |
|
|
6/30/04 |
|
|
6/30/05 |
|
|
6/30/06 |
|
|
6/29/07 |
|
|
Marshall Edwards, Inc. Common Stock |
|
|
$ |
100.00 |
|
|
|
$ |
99.07 |
|
|
|
$ |
95.07 |
|
|
|
$ |
45.20 |
|
|
|
$ |
40.93 |
|
|
|
NASDAQ Composite Index |
|
|
$ |
100.00 |
|
|
|
$ |
104.68 |
|
|
|
$ |
105.15 |
|
|
|
$ |
111.04 |
|
|
|
$ |
133.08 |
|
|
|
NASDAQ Biotechnology Index |
|
|
$ |
100.00 |
|
|
|
$ |
107.78 |
|
|
|
$ |
98.00 |
|
|
|
$ |
105.44 |
|
|
|
$ |
113.93 |
|
|
|
38
Item 6. Selected Financial Data
The following selected financial data should be read in conjunction with Item 7. Managements
Discussion and Analysis of Financial Condition and Results of Operations and Item 8. Financial
Statements included elsewhere in this Annual Report on Form 10-K.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended June 30, |
Statement of Operations |
|
2007 |
|
2006 |
|
2005 |
|
2004 |
|
2003 |
|
|
(in thousands, except per share data) |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
$ |
645 |
|
|
$ |
446 |
|
|
$ |
308 |
|
|
$ |
193 |
|
|
$ |
145 |
|
|
|
|
Total revenues |
|
|
645 |
|
|
|
446 |
|
|
|
308 |
|
|
|
193 |
|
|
|
145 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(13,819 |
) |
|
|
(7,385 |
) |
|
|
(6,421 |
) |
|
|
(8,538 |
) |
|
|
(3,033 |
) |
Income tax expense |
|
|
(1 |
) |
|
|
(1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss arising during development stage |
|
$ |
(13,820 |
) |
|
$ |
(7,386 |
) |
|
$ |
(6,421 |
) |
|
$ |
(8,538 |
) |
|
$ |
(3,033 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.22 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.16 |
) |
|
$ |
(0.06 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding |
|
|
63,196,465 |
|
|
|
56,938,000 |
|
|
|
56,938,000 |
|
|
|
54,954,578 |
|
|
|
52,023,247 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, |
Balance Sheet Data |
|
2007 |
|
2006 |
|
2005 |
|
2004 |
|
2003 |
|
|
(in thousands) |
Cash and cash equivalents |
|
$ |
16,158 |
|
|
$ |
10,054 |
|
|
$ |
9,238 |
|
|
$ |
24,819 |
|
|
$ |
7,244 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
16,290 |
|
|
$ |
10,395 |
|
|
$ |
19,364 |
|
|
$ |
24,849 |
|
|
$ |
7,286 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity |
|
$ |
13,777 |
|
|
$ |
9,135 |
|
|
$ |
16,521 |
|
|
$ |
22,942 |
|
|
$ |
5,933 |
|
Item 7. Managements Discussion and Analysis of Financial Condition and results of
Operations.
The following discussion and analysis should be read in conjunction with Item 8. Financial
Statements and Supplementary Data included below. Operating results are not necessarily indicative
of results that may occur in future periods. This discussion and analysis contains forward-looking
statements that involve risks, uncertainties and assumptions. The actual results may differ
materially from those anticipated in the forward-looking statements as a result of many factors
including, but not limited to, those set forth under Cautionary Statement About Forward-Looking
Statements and Risk Factors in Item 1A. included above in this Annual Report on Form 10-K. All
forward-looking statements included in this document are based on the information available to us
on the date of this document and we assume no obligation to update any forward-looking statements
contained in this Annual Report on Form 10-K.
Overview
Our main focus since commencing operations is to undertake human clinical testing of phenoxodiol.
Operations have now expanded to include the recently licenced 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 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 therapy.
39
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 our drug candidates into later stages of development and incur expenses for the
OVATURE trial. As of June 30, 2007, we had accumulated losses of $39,321,000.
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 our
drug candidates and costs incurred under the licence agreements, the services agreement and the
manufacturing licence and supply agreements with Novogen and its subsidiaries, including the costs
of the clinical trial drug supplies as well as costs associated with phenoxodiol production
scale-up activities and drug supply from third party contractors .
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.
To date, operations have been funded primarily through the sale of equity securities.
Critical Accounting Estimates
The preparation of the consolidated financial statements in conformity with accounting principles
generally accepted in the United States requires management to make estimates and assumptions that
affect the amounts reported in the financial statements and the accompanying notes. Actual results
could differ from those estimates.
Development Expenses
Research and development costs incurred since inception through June 30, 2007 amount to
$15,941,000.
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 to incorporate NV-196 and NV-143. The
phenoxodiol Phase III OVATURE trial will require large patient numbers resulting in significantly
increased costs.
40
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; |
|
|
|
|
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 dates 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 recently licenced from Novogen. We will also continue to assess the opportunity to licence
other cancer drugs developed by Novogen as the opportunities arise.
Clinical Trials 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 $2,255,000 have been included in the financial statements for the year
ended June 30, 2007, of which $548,000 has been accrued at June 30, 2007. These estimates are based
on the number of patients in each trial and the drug administration cycle.
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
and drug supply 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.
41
Drug supply/manufacturing scale-up expenses of $1,860,000 have been included in the financial
statements for the year ended June 30, 2007, of which $339,000 has been accrued at June 30, 2007.
These estimates are based on the milestones completed for each of the service contracts.
Results of Operations
Summary of Revenue and Expenses
The following table provides a summary of revenues and expenses to supplement the more detailed
discussions below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended June 30, |
Revenues |
|
2007 |
|
2006 |
|
2005 |
|
|
|
|
|
(in thousands) |
Interest and other income |
|
$ |
645 |
|
|
$ |
446 |
|
|
$ |
308 |
|
|
|
|
Total revenues |
|
|
645 |
|
|
|
446 |
|
|
|
308 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended June 30, |
Research and development expenses |
|
2007 |
|
2006 |
|
2005 |
|
|
|
|
|
(in thousands) |
Clinical trial study costs |
|
$ |
(2,255 |
) |
|
$ |
(840 |
) |
|
$ |
(1,156 |
) |
Drug/manufacturing scale-up costs |
|
|
(1,860 |
) |
|
|
(1,856 |
) |
|
|
(612 |
) |
Research and development service charge |
|
|
(1,145 |
) |
|
|
(588 |
) |
|
|
(385 |
) |
Other |
|
|
(501 |
) |
|
|
(143 |
) |
|
|
(126 |
) |
|
|
|
Total Research and Development Costs |
|
|
(5,761 |
) |
|
|
(3,427 |
) |
|
|
(2,279 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended June 30, |
License Fees |
|
2007 |
|
2006 |
|
2005 |
|
|
|
|
|
(in thousands) |
License Fees |
|
|
(5,000 |
) |
|
|
(3,000 |
) |
|
|
(3,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended June 30, |
Selling, general and administrative expenses |
|
2007 |
|
2006 |
|
2005 |
|
|
|
|
|
(in thousands) |
Legal and professional fees |
|
$ |
(488 |
) |
|
$ |
(394 |
) |
|
$ |
(371 |
) |
Administrative service charge |
|
|
(818 |
) |
|
|
(707 |
) |
|
|
(688 |
) |
Share based payment |
|
|
(1,642 |
) |
|
|
|
|
|
|
|
|
Other |
|
|
(755 |
) |
|
|
(303 |
) |
|
|
(391 |
) |
|
|
|
Total operating expenses |
|
|
(3,703 |
) |
|
|
(1,404 |
) |
|
|
(1,450 |
) |
|
|
|
Year Ended June 30, 2007 Compared to the Year Ended June 30, 2006
We recorded a consolidated loss of $13,820,000 and $7,386,000 for the years ended June 30, 2007 and
2006, respectively.
Revenues: We received interest on cash assets and cash equivalents of $645,000 for the year ended
June 30, 2007 versus $446,000 for the year ended June 30, 2006. This increase was due to higher
cash balances combined with an increase in interest rates.
42
Research and Development: Research and development expenses increased $2,334,000 to $5,761,000 for
the year ended June 30, 2007 compared to $3,427,000 for the year ended June 30, 2006. This increase
was primarily due to increased clinical trial costs incurred associated with OVATURE and the
additional costs incurred under the services agreement reflecting the increased time spent by
Novogen research staff on the development of phenoxodiol, NV-196 and NV-143.
Licence Fees: Milestone licence fees of $5,000,000 were expensed for the year ended June 30, 2007
compared to $3,000,000 for the year ended June 30, 2006. The $5,000,000 expensed in the year ended
June 30, 2007 represents the second lump sum licence fee due under the terms of the licence
agreement. This second lump sum licence 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 revenues
received from commercialization (income other than sales) and sales of phenoxodiol products exceeds
$50,000,000. Following the private placement or PIPE capital raising closed on July 11, 2006, the
funds received from equity issuances exceeded $50,000,000 which triggered this licence fee payment.
The $3,000,000 expensed in the year ended June 30, 2006 represents 50 percent ($2,000,000) of the
December 31, 2005 annual milestone licence fee of $4,000,000 (the other 50 percent was incurred and
accrued in the year ended June 30, 2005) and $1,000,000 that was payable on execution of the new
licence agreement with Novogen in relation to the drug candidates NV-196 and NV-143 licenced in May
2006.
Selling, General and Administrative: Selling, general and administrative expenses increased by
$2,299,000 to $3,703,000 for the year ended June 30, 2007 compared to $1,404,000 for the year ended
June 30, 2006. The increase was due primarily to the cost of the share-based payment of the SEDA
commitment fee paid to Cornell Capital Partners, LP (Cornell) in the form of shares and warrants
which were valued at $1,642,000 and general corporate expenses including an increase in legal
compliance costs, travel and service fees paid to Novogen reflecting an increase in corporate and
accounting services and insurance.
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 MEPL. MEPL uses U.S. dollars as its functional currency and also engages in
transactions in foreign currencies. Further, MEPLs accounts and financial statements are
denominated in Australian dollars. Translation of MEPLs financial statements into U.S. dollars did
not have a material impact on our financial position. At June 30, 2007, we had not established a
foreign currency hedging program. Net foreign exchange losses during the twelve months ended June
30, 2007 were $98,000 compared with net exchange losses of $2,000 during the twelve months ended
June 30, 2006.
Year Ended June 30, 2006 Compared to the Year Ended June 30, 2005
We recorded a consolidated loss of $7,386,000 and $6,421,000 for the years ended June 30, 2006 and
2005, respectively.
Revenues: We received interest on cash assets and cash equivalents of $446,000 for the year ended
June 30, 2006 versus $308,000 for the year ended June 30, 2005. This increase was due to an
increase
in interest rates combined with us investing some of our cash in short term investment deposits in
the first half of the year which yield a greater rate of return than cash accounts.
43
Research and Development: Research and development expenses increased $1,148,000 to $3,427,000 for
the year ended June 30, 2006 compared to $2,279,000 for the year ended June 30, 2005. This increase
was primarily due to third party contract costs associated with the production scale-up activities
of the manufacturing process of phenoxodiol and the initial development of the NDA documentation
together with the additional costs incurred under the services agreement reflecting the increase
time spent by Novogen research staff on the development of phenoxodiol. These increases were
partially offset by a reduction in the clinical trial study costs incurred as a number of studies
are nearing completion. Clinical trial drug costs have also reduced as many patients have now
completed the treatment cycles. We expect research and development clinical trial costs to increase
significantly in the future due to the planned Phase III OVATURE study.
Licence Fees: Milestone licence fees of $3,000,000 were expensed for both the years ended June 30,
2006 and June 30, 2005. The $3,000,000 expensed in the year ended June 30, 2006 represents 50
percent ($2,000,000) of the December 31, 2005 annual milestone licence fee of $4,000,000 (the other
50 percent was incurred and accrued in the year ended June 30, 2005) and $1,000,000 that was
payable on execution of the new licence agreement with Novogen in relation to the drug candidates
NV-196 and NV-143 licenced in May 2006. The $3,000,000 milestone licence fees expensed in the year
ended June 30, 2005 represents 50 percent ($2,000,000) of the December 31, 2005 annual milestone
licence fee of $4,000,000 plus 50 percent ($1,000,000) of the December 31, 2004 annual milestone
licence fee of $2,000,000.
Selling, General and Administrative: Selling, general and administrative expenses decreased by
$46,000 to $1,404,000 for the year ended June 30, 2006 compared to $1,450,000 for the year ended
June 30, 2005. The decrease was due primarily to a reduction in foreign exchange losses and legal
fees which were partially offset by an increase in travel costs. Foreign exchange gains/(losses)
are included in selling, general and administrative expenses which occur when revaluing cash
denominated in foreign currencies and upon consolidation of our wholly owned subsidiary MEPL. MEPL
uses US dollars as its functional currency and also engages in transactions in foreign currencies.
Further, MEPLs accounts and financial statements are denominated in Australian dollars.
Translation of MEPLs financial statements into U.S. dollars did not have a material impact on our
financial position. At June 30, 2006, we had not established a foreign currency hedging program.
Net foreign exchange losses during the twelve months ended June 30, 2006 were $2,000 compared with
net exchange losses of $24,000 during the twelve months ended June 30, 2005.
Liquidity and Capital Resources
At June 30, 2007, we had cash resources of $16,158,000 compared to $10,054,000 at June 30, 2006.
The increase was due to the capital raising in July 2006, as described below, which was partially
offset by the payment of the $5,000,000 second lump sum licence fee and expenditures in the
clinical trial program and other corporate expenses incurred during the year. Funds are invested in
short term money accounts, pending use.
On July 11, 2006, the we entered into a securities subscription agreement with certain accredited
investors providing for the placement of 6,329,311 shares of our common stock and warrants
exercisable for 2,215,258 shares of our 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. We closed the private placement on July 11, 2006. In connection with the private
placement or PIPE, we received proceeds of $16.8 million net of $1.5 million commissions and other
costs.
44
On July 11, 2006, we entered into the SEDA with Cornell. Under the SEDA, we may issue and sell to
Cornell shares of our common stock for a total purchase price of up to $15 million, once a resale
registration statement is in effect. Commencing as of the effective date of the registration
statement and continuing for up to 24 months thereafter, we have sole discretion whether and when
to sell shares of our common stock to Cornell. Cornell will be irrevocably bound to purchase shares
of common stock from us after we send a notice that we intend to sell shares of our common stock to
Cornell. Each advance under the SEDA is limited to a maximum of $1.5 million.
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 gross proceeds of
$16.4 million.
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 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.
In addition, we have terminated the SEDA with Cornell.
Source and Uses of Cash
Cash Used in Operating Activities
Cash used in operating activities for the year ended June 30, 2007 was $10,786,000 compared to
$9,089,000 for the same period in 2006. The increase in cash outflow of $1,697,000 for the year
ended June 30, 2007 was due primarily to the second lump sum licence fee paid to Novogen of
$5,000,000 during the period compared to $4,000,000 paid in the corresponding period. Additional
cash outflow was also incurred in connection with the increased costs associated with the Phase III
OVATURE trial and the scale-up costs of phenoxodiol.
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.
45
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.
Licence Agreement for Phenoxodiol
In September 2003, we entered into a licence agreement pursuant to which Novogens subsidiary,
Novogen Research Pty Limited, granted to MEPL a worldwide non-transferable licence under its
patents and patent applications and in its know-how to conduct clinical trials and commercialize
and distribute phenoxodiol products. The 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 licence 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. MEPL paid $5,000,000 to Novogen in February
2004 which was the first lump sum licence fee payment due under the terms of the 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 licence fee payments due under the licence agreement. We paid a second lump sum
licence fee of $5,000,000 to Novogen in July 2006 following the raising of funds in a private
placement or PIPE closed on July 11, 2006. This licence 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 private placement or PIPE closed on July
11, 2006, the funds received from equity issuances exceeded $50,000,000 which triggered this
licence fee payment. Future amounts payable to Novogen under terms of the licence agreement are as
follows:
1. Until the expiration of the exclusivity period of the licence, MEPL must pay Novogen 2.5% of all
net sales and 25% of commercialization income. After the exclusivity period of the licence, 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 licence agreement with Novogen; or |
|
(b) |
|
the date of expiration or lapsing of the last licenced patent right which MEPL would, but for
the licence granted in the licence agreement, infringe in any country in the geographical
territory covered by the licence agreement by doing in that country any of the things set out
in the licence agreement. |
2. In addition to the amounts above, beginning in 2006, an $8 million annual milestone licence fee
is payable under the amended terms of the licence agreement for each calendar year ending December
31
during the exclusivity period of the licence. The December 31, 2006 licence fee has been deferred
under the licence amendment deed which is discussed below.
46
Licence Amendment Deed for Phenoxodiol
In June 2006, we entered into an amendment deed to the licence agreement for phenoxodiol. Pursuant
to the original term of the licence agreement for phenoxodiol we were required to pay an $8,000,000
licence milestone fee to Novogen Research Pty Limited in December 2006. The amendment deed extends
the date that the $8,000,000 licence milestone fee is payable until the earliest receipt by MEPL of
the first:
(i) approval by the FDA of an 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 licence fee 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 licence agreement for phenoxodiol for the purpose of further amending and
restating the license agreement (the Further Amended and Restated License Amendment).
The combined result of the Licence 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 License Agreement.
No licence fees have been accrued at June 30, 2007.
Licence Agreement NV-196 and NV-143
In May 2006, we entered into a second licence agreement with Novogen for two oncology compounds,
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 licence agreement is an
agreement under which Novogens subsidiary, Novogen Research Pty Limited, grants to MEPL a
worldwide non-transferable licence 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 licence
agreement 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 licence 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. MEPL paid $1,000,000 to Novogen in May 2006 which was the first lump sum licence fee
payment due under the terms of the licence agreement. We are required to make payments under the
terms of this second licence agreement with Novogen as follows:
47
1. A lump sum licence fee of $1,000,000 is payable to Novogen on the commencement date of the
licence in consideration of the licence granted. This initial lump sum licence fee was paid to
Novogen in May 2006.
2. MEPL must pay to Novogen the following milestone licence fees upon the occurrence of the
corresponding milestone as set forth below:
|
a) |
|
the first licenced product containing NV-196 to reach a milestone as set forth below; and
|
|
|
b) |
|
the first licenced product containing NV-143 to reach a milestone as set forth below. |
The milestone licence fees are:
|
i) |
|
$1,000,000 on the date an IND for the licenced 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 licenced 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 licenced 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 licenced 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 licence. The royalty rate is reduced by 50% if the licenced 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 licenced product from the FDA (or equivalent approval from a government agency in any
other country) until the expiration of the term.
The licence agreement is able to be cancelled without penalty by MEPL by giving three months
notice. Therefore licence fees due under the licence agreement are recognised as an expense when
the milestone event occurs.
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.
We are currently assessing the future cash requirements needed to fund new clinical trial
initiatives and licensing options available under the license option deed.
Contractual Obligations
At June 30, 2007, we had contractual obligations for the conduct of clinical trials, pre-clinical
research and development and manufacturing process development of approximately $10,318,000. Of all
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.
48
The following table summarizes our future payment obligations and commitments as of June 30, 2007
assuming all treatment cycles are completed:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands) |
|
|
|
|
|
Payment due by period |
|
|
|
|
|
|
less than 1 |
|
1 - 3 |
|
3 - 5 |
|
More than |
Contractual Obligations |
|
Total |
|
Year |
|
Years |
|
Years |
|
5 Years |
Purchase Obligations |
|
$ |
10,318 |
|
|
$ |
6,446 |
|
|
$ |
3,652 |
|
|
$ |
220 |
|
|
$ |
|
|
Total |
|
$ |
10,318 |
|
|
$ |
6,446 |
|
|
$ |
3,652 |
|
|
$ |
220 |
|
|
$ |
|
|
No amounts have been included in the above table for future payments to Novogen which may
arise in connection with the licence agreements, the services agreement or the manufacturing 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 above and in Note 6 Related
Party Transactions to the Consolidated Financial Statements.
Off-Balance Sheet Arrangements
We do not currently have any off-balance sheet arrangements.
49
Item 7a. Quantitative and Qualitative Disclosures about Market Risk
Interest Rate Risk
We place cash in on call and short-term deposit accounts 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 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 June 30, 2007, we had not established a foreign currency hedging program. Net foreign
exchange losses during the twelve months ended June 30, 2007 were $98,000 compared with net
exchange losses of $2,000 during the twelve months ended June 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. MEPLs accounts are denominated in Australian
dollars. Translation of MEPLs 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.
50
Item 8. Financial Statements and Supplementary Data
Marshall Edwards, Inc
Index to Financial Statements
Report of BDO Kendalls (NSW) Independent Registered Public Accounting Firm
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statements of Stockholders Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
51
|
|
|
|
|
BDO Kendalls (NSW)
Level 19.2 Market St
Sydney NSW 2000
GPO Box 2551 Sydney NSW 2001
Phone 61 2 9286 5555
Fax 61 2 9286 5599
info.sydney@bdo.com.au
ww.bdo.com.au |
|
|
|
|
|
ABN 57 908 209 104 |
Report of Independent Registered Public Accounting Firm
Board of Directors
Marshall Edwards, Inc.
We have audited the accompanying consolidated balance sheet of Marshall Edwards, Inc. (a
development stage company) as of June 30, 2007 and 2006, and the related statements of
operations, stockholders equity, and cash flows for each of the years in the three year period
ended June 30, 2007, and for the period from December 1, 2000 (inception) through June 30, 2007.
These
financial statements are the responsibility of the Companys management. Our responsibility is to
express an opinion on these financial statements based on our audit.
We conducted our audits in accordance with the standards of the Public Company Accounting
Oversight Board (United States). Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether the financial statements are free of material
misstatement. The Company is not required to have, nor were we engaged to perform, an audit
of its internal control over financial reporting. Our audits included consideration of internal
control over financial reporting as a basis for designing audit procedures that are appropriate in
the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the
Companys internal control over financial reporting. Accordingly, we express no such opinion. An
audit also includes examining, on a test basis, evidence supporting the amounts and disclosures
in the financial statements, assessing the accounting principles used and significant estimates
made by management, as well as evaluating the overall financial statement presentation. We
believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all
material respects, the consolidated financial position of Marshall Edwards, Inc. at June 30, 2007
and 2006, and the consolidated results of its operations and its cash flows each of the years in
the three year period ended June 30, 2007 and the period from December 1, 2000 (inception) through
June
30, 2007, in conformity with accounting principles generally accepted in the United States of
America.
BDO Kendalls (NSW)
Sydney, NSW, Australia
September 27, 2007
52
MARSHALL EDWARDS, INC.
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
June 30, |
|
|
2007 |
|
2006 |
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
16,158 |
|
|
$ |
10,054 |
|
Deferred Offering Costs |
|
|
25 |
|
|
|
95 |
|
Prepaid expenses and other current assets |
|
|
107 |
|
|
|
246 |
|
|
|
|
Total current assets |
|
|
16,290 |
|
|
|
10,395 |
|
|
|
|
Total assets |
|
$ |
16,290 |
|
|
$ |
10,395 |
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,197 |
|
|
$ |
420 |
|
Accrued expenses |
|
|
984 |
|
|
|
638 |
|
Amount due to related company |
|
|
332 |
|
|
|
202 |
|
|
|
|
Total current liabilities |
|
|
2,513 |
|
|
|
1,260 |
|
|
|
|
|
|
|
|
|
|
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: 63,390,937 at
June 30, 2007 and 56,938,000 at June 30, 2006 |
|
|
|
|
|
|
|
|
Additional paid-in capital |
|
|
53,098 |
|
|
|
34,636 |
|
Deficit accumulated during development stage |
|
|
(39,321 |
) |
|
|
(25,501 |
) |
|
|
|
Total stockholders equity |
|
|
13,777 |
|
|
|
9,135 |
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
16,290 |
|
|
$ |
10,395 |
|
|
|
|
See accompanying notes.
53
MARSHALL EDWARDS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 1, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2000 (Inception) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
through |
|
|
Years Ended June 30, |
|
June 30, |
|
|
2007 |
|
2006 |
|
2005 |
|
2007 |
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
$ |
645 |
|
|
$ |
446 |
|
|
$ |
308 |
|
|
$ |
1,744 |
|
|
|
|
Total revenues |
|
|
645 |
|
|
|
446 |
|
|
|
308 |
|
|
|
1,744 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
(5,761 |
) |
|
|
(3,427 |
) |
|
|
(2,279 |
) |
|
|
(15,941 |
) |
License fees |
|
|
(5,000 |
) |
|
|
(3,000 |
) |
|
|
(3,000 |
) |
|
|
(17,000 |
) |
Selling, general and administrative |
|
|
(3,703 |
) |
|
|
(1,404 |
) |
|
|
(1,450 |
) |
|
|
(8,121 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
(14,464 |
) |
|
|
(7,831 |
) |
|
|
(6,729 |
) |
|
|
(41,062 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(13,819 |
) |
|
|
(7,385 |
) |
|
|
(6,421 |
) |
|
|
(39,318 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
(1 |
) |
|
|
(1 |
) |
|
|
|
|
|
|
(3 |
) |
|
|
|
Net loss arising during development stage |
|
$ |
(13,820 |
) |
|
$ |
(7,386 |
) |
|
$ |
(6,421 |
) |
|
$ |
(39,321 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.22 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.11 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding |
|
|
63,196,465 |
|
|
|
56,938,000 |
|
|
|
56,938,000 |
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
54
MARSHALL EDWARDS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 1, 2000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Inception) |
|
|
Years Ended June 30, |
|
through June 30, |
|
|
2007 |
|
2006 |
|
2005 |
|
2007 |
|
|
|
Operating activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss arising during development stage |
|
|
(13,820 |
) |
|
|
(7,386 |
) |
|
|
(6,421 |
) |
|
|
(39,321 |
) |
Adjustments to reconcile net loss to net cash
used in operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share based payments |
|
|
1,642 |
|
|
|
|
|
|
|
|
|
|
|
1,642 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
139 |
|
|
|
(120 |
) |
|
|
(96 |
) |
|
|
(107 |
) |
Accounts payable |
|
|
777 |
|
|
|
166 |
|
|
|
62 |
|
|
|
1,197 |
|
Accrued expenses |
|
|
346 |
|
|
|
235 |
|
|
|
(34 |
) |
|
|
984 |
|
Amounts due to related company |
|
|
130 |
|
|
|
(1,984 |
) |
|
|
908 |
|
|
|
332 |
|
|
|
|
Net cash used in operating activities |
|
|
(10,786 |
) |
|
|
(9,089 |
) |
|
|
(5,581 |
) |
|
|
(35,273 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from issuance of Common Stock |
|
|
16,915 |
|
|
|
|
|
|
|
|
|
|
|
51,551 |
|
Deferred Offering Costs |
|
|
(25 |
) |
|
|
(95 |
) |
|
|
|
|
|
|
(120 |
) |
Withdrawal from/(investment in) short-term deposits |
|
|
|
|
|
|
10,000 |
|
|
|
(10,000 |
) |
|
|
|
|
|
|
|
Net cash provided by/(used in) financing activities |
|
|
16,890 |
|
|
|
9,905 |
|
|
|
(10,000 |
) |
|
|
51,431 |
|
Net increase/(decrease) in cash and cash
equivalents |
|
|
6,104 |
|
|
|
816 |
|
|
|
(15,581 |
) |
|
|
16,158 |
|
Cash and cash equivalents at beginning of period |
|
|
10,054 |
|
|
|
9,238 |
|
|
|
24,819 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
|
16,158 |
|
|
|
10,054 |
|
|
|
9,238 |
|
|
|
16,158 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes paid |
|
|
(1 |
) |
|
|
(1 |
) |
|
|
|
|
|
|
(3 |
) |
|
|
|
See accompanying notes.
55
MARSHALL EDWARDS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENT OF STOCKHOLDERS EQUITY
(In thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
accumulated |
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
during |
|
other |
|
|
|
|
Common |
|
Additional paid |
|
development |
|
comprehensive |
|
|
|
|
Stock |
|
in capital |
|
stage |
|
income/(loss) |
|
Total |
|
|
|
|
|
(shares) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance June 30, 2001 |
|
|
49,500,000 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Net loss arising during development stage |
|
|
|
|
|
|
|
|
|
|
(123 |
) |
|
|
|
|
|
|
(123 |
) |
Common Stock issued May 22, 2002
(including 2,523,000 warrants) |
|
|
2,523,000 |
|
|
|
9,022 |
|
|
|
|
|
|
|
|
|
|
|
9,022 |
|
|
|
|
Balance at June 30, 2002 |
|
|
52,023,000 |
|
|
|
9,022 |
|
|
|
(123 |
) |
|
|
|
|
|
|
8,899 |
|
Net loss arising during development stage |
|
|
|
|
|
|
|
|
|
|
(3,033 |
) |
|
|
|
|
|
|
(3,033 |
) |
Foreign currency translation adjustments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31 |
|
|
|
31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,002 |
) |
Common Stock issued June 26, 2003 |
|
|
9,000 |
|
|
|
36 |
|
|
|
|
|
|
|
|
|
|
|
36 |
|
|
|
|
Balance at June 30, 2003 |
|
|
52,032,000 |
|
|
|
9,058 |
|
|
|
(3,156 |
) |
|
|
31 |
|
|
|
5,933 |
|
Net loss arising during development stage |
|
|
|
|
|
|
|
|
|
|
(8,538 |
) |
|
|
|
|
|
|
(8,538 |
) |
Foreign currency translation adjustments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(31 |
) |
|
|
(31 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,569 |
) |
Common Stock issued November 30, 2003 |
|
|
2,514,000 |
|
|
|
10,056 |
|
|
|
|
|
|
|
|
|
|
|
10,056 |
|
Common Stock issued December 18, 2003
(including 2,392,000 warrants) |
|
|
2,392,000 |
|
|
|
15,522 |
|
|
|
|
|
|
|
|
|
|
|
15,522 |
|
|
|
|
Balance at June 30, 2004 |
|
|
56,938,000 |
|
|
$ |
34,636 |
|
|
$ |
(11,694 |
) |
|
$ |
|
|
|
$ |
22,942 |
|
Net loss arising during development stage |
|
|
|
|
|
|
|
|
|
|
(6,421 |
) |
|
|
|
|
|
|
(6,421 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,421 |
) |
|
|
|
Balance at June 30, 2005 |
|
|
56,938,000 |
|
|
$ |
34,636 |
|
|
$ |
(18,115 |
) |
|
$ |
|
|
|
$ |
16,521 |
|
Net loss arising during development stage |
|
|
|
|
|
|
|
|
|
|
(7,386 |
) |
|
|
|
|
|
|
(7,386 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,386 |
) |
|
|
|
Balance at June 30, 2006 |
|
|
56,938,000 |
|
|
|
34,636 |
|
|
|
(25,501 |
) |
|
|
|
|
|
$ |
9,135 |
|
Net loss arising during development stage |
|
|
|
|
|
|
|
|
|
|
(13,820 |
) |
|
|
|
|
|
|
(13,820 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(13,820 |
) |
Common Stock issued July 11, 2006 |
|
|
6,329,311 |
|
|
|
16,820 |
|
|
|
|
|
|
|
|
|
|
|
16,820 |
|
Shares issued as share-based payment
(refer Note 7) |
|
|
123,626 |
|
|
|
443 |
|
|
|
|
|
|
|
|
|
|
|
443 |
|
Warrants
issued as share-based payment (refer Note 7) |
|
|
|
|
1,199 |
|
|
|
|
|
|
|
|
|
|
|
1,199 |
|
|
|
|
Balance at June 30, 2007 |
|
|
63,390,937 |
|
|
|
53,098 |
|
|
|
(39,321 |
) |
|
|
|
|
|
$ |
13,777 |
|
|
|
|
See accompanying notes.
56
MARSHALL EDWARDS, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2007
1. The Company and Summary of Significant Accounting Policies
Marshall Edwards, Inc. (MEI 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 development of the
anti-cancer drug phenoxodiol. Novogens subsidiary has granted to the Companys subsidiary,
Marshall Edwards Pty Ltd (MEPL), a worldwide non-transferable licence under its patent right and
patent applications and its relevant know-how to conduct clinical trials and commercialize and
distribute all forms of phenoxodiol 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 Companys common stock.
The Companys main focus since commencing operations is to undertake human clinical testing of
phenoxodiol. Operations have now expanded to include the recently licenced drug candidates NV-196
and NV-143. During fiscal year 2007, we commenced the OVATURE Phase III clinical trial for
phenoxodiol (known as OVATURE) 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 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 therapy.
Principles of Consolidation
The consolidated financial statements include the accounts of the Company 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 by the Company to date is interest on cash balances, which is recognised on
an accruals basis.
57
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 Companys 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.
Fair Value of Financial Instruments
The carrying amounts of the Companys financial instruments, including cash and cash equivalents,
short-term investments 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 MEPLs financial statements into U.S dollars does not have a material impact on the
Companys financial position.
Research and Development Expenses
Research and development expenses relate primarily to the cost of conducting human clinical trials
of phenoxodiol and has recently been expanded to include NV-196 and NV-143. Research and
development costs are charged to expense as incurred.
Licence 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 Companys stock option plan provides for the grant of options to the Companys directors,
employees, employees of the Companys affiliates and certain of the Companys contractors and
consultants. To date no options have been issued under the plan.
58
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 is excluded, whereas for diluted earnings per share it is 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.
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 recognised 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.
Recent Accounting Standards
In February 2007, the Financial Accounting Standards Board (FASB) issued SFAS No.159 (SFAS 159),
The Fair Value Option for Financial Assets and Financial Liabilities which permits an entity to
measure certain financial assets and financial liabilities at fair value. The purpose of SFAS 159
is to improve financial reporting by allowing entities to mitigate volatility in reported earnings
caused by the measurement of related assets and liabilities using different attributes, without
having to apply complex hedge accounting provisions. Under SFAS 159, entities that elect the fair
value option by instrument will report unrealised gains and losses in earnings at each subsequent
reporting date. The fair value option is irrevocable, unless a new election date occurs. SFAS 159
established presentation and disclosure requirements to help financial statement users to
understand the effect of the entitys election on its earnings, but does not eliminate disclosure
requirements of other accounting standards. Assets and liabilities that are measured at fair value
must be displayed on the face of the balance sheet. This statement is effective as of the beginning
of fiscal year 2009. The Company is currently evaluating the impact of adopting SFAS 159 and does
not anticipate a material effect.
59
In September 2006, the Securities and Exchange Commission (SEC) issued Staff Accounting Bulletin
No. 108 (SAB 108), Considering the effects of Prior Year Misstatements when Quantifying the
Misstatements in Current Year Financial Statements. This bulletin discusses the utilization of
quantifying the effects of financial statement misstatements by using a dual approach to assess
these effects, which includes both a focus on the balance sheet and income statement. SAB 108 was
effective for fiscal 2007 and did not have any effect on the Companys consolidated financial
statements.
In September 2006, the FASB issued SFAS No. 157 (SFAS 157). Fair Value Measurements. This
pronouncement defines fair value, established a framework for measuring fair value and expands
disclosures about fair value measurements. This statement is effective as of the beginning of
fiscal year 2009. The Company is currently evaluating the impact of adopting SFAS 157 and does not
anticipate a material effect.
In June 2006, the FASB issued FASB Interpretation No.48 (FIN 48), Accounting for Uncertainty
in Income taxes an interpretation of FASB Statement No. 109, which clarifies the accounting for
uncertainty in tax positions. This interpretation requires the Company to recognize in the
financial statements the impact of a tax position, if that position is more likely than not of
being sustained on audit, based on the technical merits of the position. The provisions of FIN 48
are effective as of the beginning of fiscal year 2008, with the cumulative effect of the change in
accounting principle being recorded as an adjustment to opening retained earnings. The Company has
adopted FIN 48 as of July 1, 2007, however the Company does not anticipate a material effect.
60
2. Income Taxes
Loss from operations consists of the following jurisdictions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended June 30, |
|
|
2007 |
|
2006 |
|
2005 |
|
|
|
|
|
(in thousands $) |
Domestic |
|
|
(1,928 |
) |
|
|
(196 |
) |
|
|
(326 |
) |
Foreign |
|
|
(11,891 |
) |
|
|
(7,189 |
) |
|
|
(6,095 |
) |
|
|
|
|
|
|
(13,819 |
) |
|
|
(7,385 |
) |
|
|
(6,421 |
) |
|
|
|
The reconciliation of income tax computed at the U.S. federal statutory tax rates to income
tax expense attributable to loss arising during development stage is:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended June 30, |
|
|
|
2007 |
|
|
|
|
|
|
|
2006 |
|
|
|
|
|
|
|
2005 |
|
|
|
|
|
|
|
(in thousands $) |
|
% |
|
(in thousands $) |
|
% |
|
(in thousands $) |
|
% |
|
|
|
Tax at US statutory rates |
|
|
4,837 |
|
|
|
35 |
|
|
|
2,585 |
|
|
|
35 |
|
|
|
2,247 |
|
|
|
35 |
|
Australian tax |
|
|
(595 |
) |
|
|
(5 |
) |
|
|
(359 |
) |
|
|
(5 |
) |
|
|
(305 |
) |
|
|
(5 |
) |
R&D Tax concession |
|
|
121 |
|
|
|
1 |
|
|
|
91 |
|
|
|
1 |
|
|
|
43 |
|
|
|
1 |
|
Over/(Under) Provision |
|
|
18 |
|
|
|
1 |
|
|
|
140 |
|
|
|
2 |
|
|
|
(128 |
) |
|
|
(2 |
) |
Exchange rate difference on
opening tax losses |
|
|
1,657 |
|
|
|
12 |
|
|
|
(301 |
) |
|
|
(4 |
) |
|
|
284 |
|
|
|
4 |
|
Change in valuation allowance |
|
|
(6,038 |
) |
|
|
(44 |
) |
|
|
(2,156 |
) |
|
|
(29 |
) |
|
|
(2,141 |
) |
|
|
(33 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax liabilities and assets are comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
Year ended June 30, |
|
|
2007 |
|
2006 |
|
|
|
|
|
(in thousands $) |
Deferred tax liabilities |
|
|
|
|
|
|
|
|
Unrealised Foreign Exchange Gain |
|
|
(13 |
) |
|
|
(2 |
) |
|
|
|
Total deferred tax liabilities |
|
|
(13 |
) |
|
|
(2 |
) |
|
|
|
|
|
|
|
|
|
Deferred tax assets |
|
|
|
|
|
|
|
|
Tax carried forward losses |
|
|
12,993 |
|
|
|
7,686 |
|
Share based payments |
|
|
574 |
|
|
|
|
|
Unrealised Foreign Exchange Loss |
|
|
39 |
|
|
|
2 |
|
Consultant and other accruals |
|
|
277 |
|
|
|
146 |
|
|
|
|
Total deferred tax assets |
|
|
13,883 |
|
|
|
7,834 |
|
|
|
|
|
|
|
|
|
|
Valuation allowance for deferred tax assets |
|
|
(13,870 |
) |
|
|
(7,832 |
) |
|
|
|
Net deferred tax assets and liabilities |
|
|
|
|
|
|
|
|
|
|
|
Management evaluates the recoverability of the deferred tax asset and the amount of the
required valuation allowance. Due to the uncertainty surrounding the realization of the tax
deductions in future tax returns, the Company has recorded a valuation allowance against its net
deferred tax asset at June 30, 2007 and 2006. At such time as it is determined that it is more
likely than not that the deferred tax assets will be realized, the valuation allowance will be
reduced.
61
There was no benefit from income taxes recorded for the period from December 1, 2000 (inception) to
June 30, 2007 due to the Companys inability to recognize the benefit of net operating losses. The
Company had federal net operating loss carry forwards of approximately $1,364,000 at June 30, 2007.
The federal net operating losses will begin to expire in 2022.
Foreign tax losses of approximately $41,717,000 at June 30, 2007, may be carried forward
indefinitely.
3. Loss Per Share
The following table sets forth the computation of basic and diluted net loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended June 30, |
|
|
2007 |
|
2006 |
|
2005 |
|
|
(In Thousands, except share data) |
Numerator |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss arising during development stage |
|
|
(13,820 |
) |
|
|
(7,386 |
) |
|
|
(6,421 |
) |
|
|
|
Numerator for diluted earnings per share |
|
$ |
(13,820 |
) |
|
$ |
(7,386 |
) |
|
$ |
(6,421 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator |
|
|
|
|
|
|
|
|
|
|
|
|
Denominator for basic earnings per share - |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares used in
computing net loss per share, basic and
diluted |
|
|
63,196,465 |
|
|
|
56,938,000 |
|
|
|
56,938,000 |
|
Effect of dilutive securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilutive potential common shares |
|
|
63,196,465 |
|
|
|
56,938,000 |
|
|
|
56,938,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted net loss per share |
|
$ |
(0.22 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.11 |
) |
During the period presented the Company had warrants outstanding that could potentially dilute
basic earnings per share in the future, but were excluded from the computation of diluted net loss
per share as the effect would have been anti-dilutive. Since the Company has a loss for all periods
presented, diluted and basic earnings per share are the same. The outstanding warrants consist of
the following potential common shares:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As at June 30, |
|
|
2007 |
|
2006 |
|
2005 |
|
|
|
Outstanding Warrants |
|
|
2,815,258 |
|
|
|
2,392,000 |
|
|
|
2,392,000 |
|
The warrants outstanding at June 30, 2007 have an exercise price of $4.35 per share and are
exercisable prior to July 11, 2010.
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 for securing a Standby Equity Distribution Agreement
62
4. Expenditure Commitments and Contingencies
At June, 30, 2007, the Company had contractual obligations for the conduct of clinical trials, pre-
clinical research and development and manufacturing process development of approximately
$10,318,000. 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 |
|
|
|
|
|
|
less than 1 |
|
1 3 |
|
3 5 |
|
More than |
Contractual Obligations |
|
Total |
|
Year |
|
Years |
|
Years |
|
5 Years |
Purchase Obligations |
|
$ |
10,318 |
|
|
$ |
6,446 |
|
|
$ |
3,652 |
|
|
$ |
220 |
|
|
$ |
|
|
Total |
|
$ |
10,318 |
|
|
$ |
6,446 |
|
|
$ |
3,652 |
|
|
$ |
220 |
|
|
$ |
|
|
No amounts have been included for future payments to Novogen which may arise in connection
with the licence agreements, the services agreement or the manufacturing licence 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 6 Related Party
Transactions.
The Company is not currently a party to any material legal proceedings.
The Companys certificate of incorporation provides that it will indemnify Novogen in connection
with certain actions brought against Novogen by any of the Companys 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 licence agreement for phenoxodiol, 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 licence agreements for phenoxodiol and
the obligations of Novogen Laboratories Pty Limited under the manufacturing licence and supply
agreement to Marshall Edwards Pty Limited. Each of the Company and Novogens obligations in the
guarantee and indemnity agreement are absolute, unconditional and irrevocable.
The Company has issued a letter of support to the directors of Marshall Edwards Pty Limited
guaranteeing financial support, for a period of twelve months ending October 3, 2007, should it be
unable to meet any of its financial commitments.
5. Segment Information
The Companys focus is to continue the clinical program currently underway for the development and
commercialization of phenoxodiol, NV-196 and NV-143. The business contains two major segments based
on geographic location.
63
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
|
|
|
|
USA |
|
|
Australia |
|
|
Total |
|
|
USA |
|
|
Australia |
|
|
Total |
|
|
USA |
|
|
Australia |
|
|
Total |
|
|
|
|
Statement of Operations |
|
(in thousands) |
|
|
(in thousands) |
|
|
(in thousands) |
|
Interest Revenue |
|
|
505 |
|
|
|
140 |
|
|
|
645 |
|
|
|
348 |
|
|
|
98 |
|
|
|
446 |
|
|
|
238 |
|
|
|
70 |
|
|
|
308 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(1,928 |
) |
|
|
(11,891 |
) |
|
|
(13,819 |
) |
|
|
(196 |
) |
|
|
(7,189 |
) |
|
|
(7,385 |
) |
|
|
(326 |
) |
|
|
(6,095 |
) |
|
|
(6,421 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income Tax Expense |
|
|
(1 |
) |
|
|
|
|
|
|
(1 |
) |
|
|
(1 |
) |
|
|
|
|
|
|
(1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss arising during development stage |
|
|
(1,929 |
) |
|
|
(11,891 |
) |
|
|
(13,820 |
) |
|
|
(197 |
) |
|
|
(7,189 |
) |
|
|
(7,386 |
) |
|
|
(326 |
) |
|
|
(6,095 |
) |
|
|
(6,421 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheet |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment assets |
|
|
50,231 |
|
|
|
1,399 |
|
|
|
51,630 |
|
|
|
33,767 |
|
|
|
2,895 |
|
|
|
36,662 |
|
|
|
33,877 |
|
|
|
4,266 |
|
|
|
38,143 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Elimination of investment in subsidiary |
|
|
(35,340 |
) |
|
|
|
|
|
|
(35,340 |
) |
|
|
(26,267 |
) |
|
|
|
|
|
|
(26,267 |
) |
|
|
(18,779 |
) |
|
|
|
|
|
|
(18,779 |
) |
|
|
|
Consolidated Assets |
|
$ |
14,891 |
|
|
$ |
1,399 |
|
|
$ |
16,290 |
|
|
$ |
7,500 |
|
|
$ |
2,895 |
|
|
$ |
10,395 |
|
|
$ |
15,098 |
|
|
$ |
4,266 |
|
|
$ |
19,364 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment liabilities |
|
$ |
110 |
|
|
$ |
2,403 |
|
|
$ |
2,513 |
|
|
$ |
180 |
|
|
$ |
1,080 |
|
|
$ |
1,260 |
|
|
$ |
93 |
|
|
$ |
2,750 |
|
|
$ |
2,843 |
|
|
|
|
6. Related Party Transactions
Licence Agreement for Phenoxodiol
In September 2003, the Company entered into a licence agreement pursuant to which Novogens
subsidiary, Novogen Research Pty Limited, granted to MEPL a worldwide non-transferable licence
under its patents and patent applications and in its know-how to conduct clinical trials and
commercialize and distribute phenoxodiol products. The 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 licence 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. MEPL paid $5,000,000 to Novogen
in February 2004 which was the first lump sum licence fee payment due under the terms of the
licence agreement. Also, MEPL paid $2,000,000 to Novogen in January 2005 and $4,000,000 in January
2006 which was the annual milestone licence fee payments due under the licence agreement. The
Company paid a second lump sum licence fee of $5,000,000 to Novogen in July 2006 following the
raising of funds in a private placement. This licence 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 private placement or PIPE closed on July 11, 2006 the
funds received from equity issuances exceeded $50,000,000 which triggered this licence fee payment.
Future amounts payable to Novogen under terms of the licence agreement are as follows:
1. Until the expiration of the exclusivity period of the licence, MEPL must pay Novogen 2.5% of all
net sales and 25% of commercialization income. After the exclusivity period of the licence, 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 licence agreement with Novogen; or |
64
(b) |
|
the date of expiration or lapsing of the last licenced patent right which MEPL would, but for
the licence granted in the licence agreement, infringe in any country in the geographical
territory covered by the licence agreement by doing in that country any of the things set out
in the licence agreement. |
2. In addition to the amounts above, beginning in 2006, an $8 million annual milestone licence fee
is payable under the amended terms of the licence agreement for each calendar year ending December
31 during the exclusivity period of the licence. The December 31, 2006 licence fee has been
deferred under the licence amendment deed which is discussed below.
Licence Amendment Deed for Phenoxodiol
In June 2006, the Company entered into an amendment deed to the licence agreement for phenoxodiol.
Pursuant to the original term of the licence agreement for phenoxodiol the Company was required to
pay an $8,000,000 licence milestone fee to Novogen Research Pty Limited in December 2006. The
amendment deed extends the date that the $8,000,000 licence 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 licence fee 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 licence agreement for phenoxodiol for the purpose of further amending and
restating the license agreement (the Further Amended and Restated License Amendment).
The combined result of the Licence Amendment Deed for Phenoxodiol and the Further Amended and
Restated License Agreement will be that upon the Approval Date, MEPL will be required to pay
Novogen Research Pty Limited $8,000,000, together with interest on such amount from (and including)
December 31, 2006 to (but excluding) the Approval Date. Thereafter, MEPL will be required to make
license milestone fee payments of $8,000,000 to Novogen Research Pty Limited on December 31 of the
year of the Approval Date and on December 31 of each year thereafter during the exclusivity period
under the License Agreement.
No licence fees have been accrued at June 30, 2007.
65
Licence Agreement NV-196 and NV-143
In May 2006, the Company entered into a second licence agreement with Novogen for two oncology
compounds, 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 licence agreement
is an agreement under which Novogens subsidiary, Novogen Research Pty Limited, grants to MEPL a
worldwide non-transferable licence 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 licence
agreement 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 licence 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. MEPL paid $1,000,000 to Novogen in May 2006 which was the first lump sum licence fee
payment due under the terms of the licence agreement. The Company is required to make payments
under the terms of this second licence agreement with Novogen as follows:
1. A lump sum licence fee of $1,000,000 is payable to Novogen on the commencement date of the
licence in consideration of the licence granted. This initial lump sum licence fee was paid to
Novogen in May 2006.
2. In further consideration of the licence granted, MEPL must pay to Novogen the following
milestone licence fees upon the occurrence of the corresponding milestone as set forth below;
a) the first licence product containing NV-196 to reach a milestone as set forth below; and
b) the first licenced product containing NV-143 to reach a milestone as set forth below.
The milestone licence fees are:
|
i) |
|
$1,000,000 on the date an IND for the licenced 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 licenced 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 licenced 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 licenced 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 licence. The royalty rate is reduced by 50% if the licenced 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 licenced product from the FDA (or equivalent approval from a government agency in any
other country) until the expiration of the term.
The licence agreement is able to be cancelled without penalty by MEPL by giving three months
notice. Therefore licence fees due under the licence agreement are recognised as an expense when
the milestone event occurs.
66
Amended and Restated Licence Option Deed
On September 24, 2003, MEPL and Novogen Resarch 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.
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 Limited or its subsidiaries have agreed
to provide services reasonably required by the Company relating to the development and
commercialization of phenoxodiol and other licenced 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 $1,963,000, $1,294,000 and $1,073,000 were
made under the Services Agreement with Novogen during the twelve months ended June 30, 2007, 2006
and 2005 respectively. Of these amounts, $1,145,000, $588,000 and $385,000 related to service fees
paid to Novogen for research and development services provided in the twelve months ended June 30,
2007, 2006 and 2005 respectively, reflecting the time spent by Novogen research staff on the
development of phenoxodiol. Additionally, $818,000, $707,000 and $688,000 of the total expenditures
during the twelve months ended June 30, 2007, 2006 and 2005, respectively, related to costs
incurred for administration and accounting services provided by Novogen.
At June 30, 2007 and 2006, $177,000 and $118,000, respectively, was due and owing to Novogen under
the services agreement and is included in amounts due to related company.
Amended and Restated Manufacturing Licence and Supply Agreement
On September 24, 2003, MEPL and Novogen Laboratories Pty Limited entered into an Amended and
Restated Manufacturing Licence and Supply Agreement (the Manufacturing Licence and Supply
Agreement).Under the terms of the Manufacturing Licence and Supply Agreement, MEPL has granted to
one of Novogens subsidiaries an exclusive, non-transferable sub licence to manufacture and supply
phenoxodiol in its primary manufactured form. Novogens subsidiary has agreed to supply phenoxodiol
to MEPL for the clinical trial development program and phenoxodiols ultimate commercial use.
Phenoxodiol supplied by Novogen under the terms of this agreement will by charged at cost plus a
50% markup.
Transactions giving rise to expenditures amounting to $153,000, $527,000 and $612,000 were made
under the manufacturing licence and supply agreement with Novogen during the twelve months ended
June 30, 2007, 2006 and 2005, respectively.
At June 30, 2007 no amount was due and owing to Novogen under the Manufacturing Licence and Supply
Agreement. At June 30, 2006 $74,000 was due and owing to Novogen and is included in amounts due to
related company.
67
Novogen has taken the strategic decision not to manufacture large scale Active Pharmaceutical
Ingredients for cancer drugs, including phenoxodiol, as these can be more economically supplied by
third parties with particular expertise in this area.
7. Equity
MEI is a development stage company incorporated in December 2000 that commenced operations in May
2002 coinciding with its listing on the London Stock Exchanges 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 Companys common stock.
In June 2003, 9,000 warrants were exercised, 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. |
In connection with the December 2003 offering, the Companys 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.
On December 18, 2006, 2,392,000 warrants which were issued in connection with the December 2003
public offering expired and no shares of common stock were issued relating to those warrants.
In January 2006, the Company voluntarily cancelled the trading of its common stock on the 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 Companys common stock
and warrants exercisable for 2,215,258 shares of the Companys 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 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 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.
68
On July 11, 2006, the Company entered into a standby equity distribution agreement (the SEDA),
with Cornell Capital Partners, LP (Cornell). Under the SEDA, the Company may issue and sell to
Cornell shares of its common stock for a total purchase price of up to $15 million, once a resale
registration statement is in effect. Commencing as of the effective date of the registration
statement and continuing for up to 24 months thereafter, the Company has sole discretion whether
and when to sell shares of its common stock to Cornell. Cornell will be irrevocably bound to
purchase shares of common stock from the Company after the Company sends a notice that it intends
to sell shares of its common stock to Cornell. Each advance under the SEDA is limited to a maximum
of $1.5 million.
In connection with the SEDA, the Company paid Cornell 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 year ended June 30, 2007.
Before the Company can sell any shares of its common stock to Cornell under the SEDA, a resale
registration statement must be filed with and declared effective by the SEC to cover Cornells
resale of shares of the Companys common stock that it buys under the SEDA.
The Company has not issued any shares of common stock under the terms of the SEDA.
Under the terms of the PIPE, the Company is required to maintain an effective registration
statement covering the resale shares of common stock issued in the PIPE and the shares of common
stock issueable upon exercise of the warrants issued in the PIPE. At the date of issuance the
Company assessed the terms of the agreement, 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.
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
agreement 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 Companys 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 the registration rights agreement
At the end of the fiscal year ending June 30, 2007 Novogen owned approximately 78.1% of the
outstanding common stock.
69
8. Significant Events After Balance Date
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 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. 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 PIPE we received gross proceeds of $16.4 million.
The
Company has 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.
In addition, the Company terminated the SEDA with Cornell.
9. Quarterly Financial Data (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 for the quarter ended |
|
Jun-30 |
|
Mar-31 |
|
Dec-31 |
|
Sep-30 |
|
Year |
|
|
(in thousands except per share data) |
Revenue |
|
|
156 |
|
|
|
171 |
|
|
|
183 |
|
|
|
135 |
|
|
|
645 |
|
Loss from operations |
|
|
(2,042 |
) |
|
|
(1,722 |
) |
|
|
(2,175 |
) |
|
|
(7,880 |
) |
|
|
(13,819 |
) |
Net Loss arising during development stage |
|
|
(2,042 |
) |
|
|
(1,723 |
) |
|
|
(2,175 |
) |
|
|
(7,880 |
) |
|
|
(13,820 |
) |
Basic and diluted loss per share |
|
|
(0.03 |
) |
|
|
(0.03 |
) |
|
|
(0.03 |
) |
|
|
(0.13 |
) |
|
|
(0.22 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 for the quarter ended |
|
Jun-30 |
|
Mar-31 |
|
Dec-31 |
|
Sep-30 |
|
Year |
|
|
(in thousands except per share data) |
Revenue |
|
|
93 |
|
|
|
101 |
|
|
|
130 |
|
|
|
122 |
|
|
|
446 |
|
Loss from operations |
|
|
(552 |
) |
|
|
(3,252 |
) |
|
|
(1,778 |
) |
|
|
(1,803 |
) |
|
|
(7,385 |
) |
Net Loss arising during development stage |
|
|
(553 |
) |
|
|
(3,252 |
) |
|
|
(1,778 |
) |
|
|
(1,803 |
) |
|
|
(7,386 |
) |
Basic and diluted loss per share |
|
|
(0.01 |
) |
|
|
(0.06 |
) |
|
|
(0.03 |
) |
|
|
(0.03 |
) |
|
|
(0.13 |
) |
10. Contingent Liabilities
On 11 July, 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 registration of those shares. An effective registration has been
maintained at the date of this report.
70
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
None.
Item 9a.
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 (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.
Changes in Internal Controls
There were no changes in internal control over financial reporting during the most recent fiscal
quarter that have materially affected, or are reasonably likely to affect the Companys internal
control over financial reporting.
Limitations on the Effectiveness of Controls
A control system no matter how well conceived and operated, can provide only reasonable, not
absolute, assurance that the objectives of the control system are met. Because of the inherent
limitations in all control systems, no evaluation of controls can provide absolute assurance that
all control issues, if any, within the company are detected. Accordingly, our disclose controls and
procedures are designed to provide reasonable not absolute assurance that the objectives of our
disclosure control system are met and, as set forth above, our chief executive officer and chief
financial officer have concluded, based on their evaluation as of the end of the period covered by
this report, that our disclosure controls and procedures were sufficiently effective to provide
reasonable assurance that the objectives of our disclosure control system were met.
Item 9b. Other Information
Not applicable
71
PART III
Item 10. Directors and Executive Officers of the Registrant
Code of Ethics
We have adopted a Code of Business and Ethics policy that applies to our directors and
employees (including our principal executive officer and our principal financial officer), and have
posted the text of our policy on our website
(www.marshalledwardsinc.com). In addition, we intend
to promptly disclose (i) the nature of any amendment to the policy that applies to our principal
executive officer and principal financial officer and (ii) the nature of any waiver, including an
implicit waiver, from a provision of the policy that is granted to one of these specified
individuals, the name of such person who is granted the waiver and the date of the waiver on our
website in the future.
The other information required by this item is incorporated herein by reference to our proxy
statement for the fiscal year ended June 30, 2007 (the Proxy Statement).
Item 11. Executive Compensation
The information required by this item is incorporated herein by reference to the Proxy Statement.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder
Matters
Certain of the information required by this item is included in Part II Item 5 of this Annual
Report and certain information is incorporated herein by reference to the Proxy Statement.
Item 13. Certain Relationships and Related Transactions
The information required by this item is incorporated herein by reference to the Proxy Statement.
Item 14. Principal Accountant Fees and Services.
The information required by this item is incorporated by reference to the Proxy Statement.
72
PART IV
Item 15. Exhibits and Financial Statement Schedules
(a) 1. Financial Statements
Reference is made to the Index to Financial Statements under Item 8, Part II hereof.
2. Financial Statement Schedules
The Financial Statement Schedules have been omitted either because they are not required or
because the information has been included in the financial statements or the notes thereto
included in this Annual Report on Form 10-K.
3. Exhibits
Exhibit Index
Exhibits
|
|
|
3.1
|
|
Restated Certificate of Incorporation (1) |
|
|
|
3.2
|
|
Amended and Restated Bylaws (21) |
|
|
|
4.1
|
|
Specimen Stock Certificate (3) |
|
|
|
4.2
|
|
Specimen Warrant Certificate (4) |
|
|
|
4.3
|
|
Specimen Warrant Certificate (5) |
|
|
|
4.4
|
|
Specimen Warrant Certificate * |
|
|
|
4.5
|
|
Warrant Agreement (6) |
|
|
|
4.6
|
|
Form of Warrant Agreement (7) |
|
|
|
4.7
|
|
Warrant Agreement (22) |
|
|
|
4.8
|
|
Amended and Restated Warrant
Agreement (26) |
|
|
|
4.9
|
|
Form of Warrant (8) |
|
|
|
4.10
|
|
Form of Warrant (23) |
|
|
|
4.11
|
|
Form of Warrant (28) |
|
|
|
10.1
|
|
Amended and Restated Licence Agreement between Novogen Research Pty
Limited and Marshall Edwards Pty Limited (9) |
|
|
|
10.2
|
|
Amended and Restated Manufacturing Licence and Supply Agreement
between Novogen Laboratories Pty Limited and Marshall Edwards Pty
Limited (10) |
|
|
|
10.3
|
|
Amended and Restated Licence Option Deed between Novogen Research
Pty Limited and Marshall Edwards Pty Limited (11) |
|
|
|
10.4
|
|
Amended and Restated Services Agreement among Novogen Limited,
Marshall Edwards, Inc. and Marshall Edwards Pty Limited (12) |
|
|
|
10.5
|
|
Guarantee and Indemnity among Marshall Edwards, Inc., Novogen
Laboratories Pty Limited, Novogen Research Pty Limited and Novogen
Limited (13) |
|
|
|
10.6
|
|
Marshall Edwards, Inc. Share Option Plan (14) |
|
|
|
10.7
|
|
Licence Agreement between Novogen Research Pty Limited and Marshall
Edwards Pty Limited (15) |
|
|
|
10.8
|
|
Amendment Deed between Novogen Research Pty Limited and Marshall
Edwards Pty Limited (16) |
|
|
|
10.9
|
|
Securities Subscription Agreement by and among Marshall Edwards,
Inc. and the investors listed on Schedule 2.1 thereto (17) |
|
|
|
10.10
|
|
Registration Rights Agreement by and among Marshall Edwards, Inc.
and the investors as signatories thereto (18) |
|
|
|
10.11
|
|
Standby Equity Distribution Agreement between Marshall Edwards, Inc.
and Cornell Capital Partners, L.P. (19) |
|
|
|
10.12
|
|
Registration Rights Agreement between Marshall Edwards, Inc. and
Cornell Capital Partners, L.P. (20) |
|
|
|
10.13
|
|
Securities Subscription Agreement, dated as of August 1, 2007 by and
among Marshall Edwards, Inc. and the investors listed on schedule
2.1 thereto (24) |
|
|
|
10.14
|
|
Registration Rights Agreement, dated as of August 6, 2007 by and
among Marshall Edwards, Inc. and the purchases signatory thereto
(25) |
|
|
|
10.15
|
|
Registration Rights Agreement,
dated as of September 26, 2007, between Marshall Edwards, Inc. and
Blue Trading, LLC (27) |
|
|
|
21.1
|
|
Subsidiaries of Marshall Edwards, Inc. (2) |
|
|
|
23.1
|
|
Consent of BDO Kendalls (NSW)* |
|
|
|
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) |
|
|
|
73
|
|
|
(1) |
|
Incorporated by reference to Exhibit 3.1 to Registrants
Registration Statement on Form S-1 filed on September 25, 2003 (Reg.
No. 333-109129). |
|
(2) |
|
Incorporated by reference to Exhibit 21 to Registrants Registration
Statement on Form S-1 filed on September 25, 2003 (Reg. No.
333-109129). |
|
(3) |
|
Incorporated by reference to Exhibit 4.1 to Amendment No. 1 to
Registrants Registration Statement on Form S-1 filed on
October 31,
2003 (Reg. No. 333-109129). |
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(4) |
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Incorporated by reference to Exhibit 4.3 Amendment No. 1 to
Registrants Registration Statement on Form S-1 filed on October 31,
2003 (Reg. No. 333-109129 ). |
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(5) |
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Incorporated by reference to Exhibit 4.2 to Registrants
Registration Statement on Form S-3 filed on August 9, 2006 (Reg. No.
333-136440 ). |
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(6) |
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Incorporated by reference to Exhibit 4.2 to Amendment No. 1 to
Registrants Registration Statement on Form S-1 filed on
October 31,
2003 (Reg. No. 333-109129 ). |
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(7) |
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Incorporated by reference to Exhibit 10.3 to Registrants Current
Report on Form 8-K filed on July 12, 2006. |
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(8) |
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Incorporated by reference to Exhibit 10.4 to Registrants Current
Report on Form 8-K filed on July 12, 2006. |
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(9) |
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Incorporated by reference to Exhibit 10.1 to Registrants
Registration Statement on Form S-1 filed on September 25, 2003 (Reg.
No. 333-109129). |
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(10) |
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Incorporated by reference to Exhibit 10.2 to Registrants
Registration Statement on Form S-1 filed on September 25, 2003 (Reg.
No. 333-109129). |
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(11) |
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Incorporated by reference to Exhibit 10.3 to Registrants
Registration Statement on Form S-1 filed on September 25, 2003 (Reg.
No. 333-109129). |
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(12) |
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Incorporated by reference to Exhibit 10.4 to Registrants
Registration Statement on Form S-1 filed on September 25, 2003 (Reg.
No. 333-109129). |
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(13) |
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Incorporated by reference to Exhibit 10.5 to Registrants
Registration Statement on Form S-1 filed on September 25, 2003 (Reg.
No. 333-109129). |
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(14) |
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Incorporated by reference to Exhibit 10.6 to Registrants
Registration Statement on Form S-1 filed on September 25, 2003 (Reg.
No. 333-109129). |
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(15) |
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Incorporated by reference to Exhibit 99.1 to Registrants Current
Report on Form 8-K filed on May 16, 2006. |
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(16) |
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Incorporated by reference to Exhibit 10.1 to Registrants Current
Report on Form 8-K filed on June 9, 2006 |
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(17) |
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Incorporated by reference to Exhibit 10.1 to Registrants Current
Report on Form 8-K/A filed on July 12, 2006. |
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(18) |
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Incorporated by reference to Exhibit 10.2 to Registrants Current
Report on Form 8-K filed on July 12, 2006. |
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(19) |
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Incorporated by reference to Exhibit 10.1 to Registrants Current
Report on Form 8-K filed on July 12, 2006. |
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(20) |
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Incorporated by reference to Exhibit 10.2 to Registrants Current
Report on Form 8-K filed on July 12, 2006. |
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(21) |
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Incorporated by reference to Exhibit 3.1 to Registrants Current
Report on Form 8-K filed on July 30, 2007. |
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(22) |
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Incorporated by reference to Exhibit 10.3 to Registrants Current
Report on Form 8-K filed on August 6, 2007. |
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(23) |
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Incorporated by reference to Exhibit 10.4 to the Registrants
Current Report on Form 8-K filed on August 6, 2007. |
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(24) |
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Incorporated by reference to Exhibit 10.1 to the Registrants
Current Report on Form 8-K filed on August 6, 2007. |
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(25) |
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Incorporated by reference to Exhibit 10.2 to the Registrants
Current Report on Form 8-K filed on August 6, 2007. |
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(26) |
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Incorporated by reference to Exhibit 4.8 to the Registrants
Current Report on Form 8-K/A filed on September 27, 2007. |
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(27) |
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Incorporated by reference to Exhibit 10.15 to the Registrants
Current Report on Form 8-K/A filed on September 27, 2007. |
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(28) |
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Incorporated by reference to Exhibit 4.11 to the Registrants
Current Report on Form 8-K/A filed on September 27, 2007. |
74
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized, on September 27, 2007.
MARSHALL EDWARDS, INC.
A Delaware Corporation
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By: |
/s/ Christopher Naughton
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Christopher Naughton |
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Chief Executive Offer |
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Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed
below by the following persons on behalf of the registrant and in the capacities indicated on
September 27, 2007.
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Signatures |
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Title |
By:
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/s/ Christopher Naughton
Christopher Naughton
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President, Chief Executive Officer and Director |
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By:
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/s/ David Seaton
David Seaton
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Secretary, Chief Financial Officer |
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By:
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/s/ Stephen Breckenridge
Stephen Breckenridge
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Director |
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By:
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/s/ Bryan Williams
Bryan Williams
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Director |
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By:
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/s/ Paul Nestel
Paul Nestel
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Director |
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By:
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/s/ Philip Johnston
Philip Johnston
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Director |
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By:
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/s/ William Rueckert
William Ruechert
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Director |
75
exv4w4
Exhibit 4.4
STOCK CERTIFICATE
CUSIP: 572322 13 9
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Marshall Edwards, Inc.
PO Box A3480 Chicago IL 60690-3480
MR A SAMPLE
DESIGNATION (IF ANY)
ADD 1
ADD 2
ADD 3
ADD 4
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CUSIP
Holder ID
Insurance Value
Number of Shares
DTC
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XXXXXX XX X
XXXXXXXXXX
1,000,000.00
123456
12345678 123456789012345 |
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Certificate Numbers |
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Num/No. |
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Denom. |
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Total |
1234567890/1234567890 |
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1 |
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1 |
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1 |
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1234567890/1234567890 |
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2 |
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2 |
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2 |
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1234567890/1234567890 |
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3 |
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3 |
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3 |
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1234567890/1234567890 |
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4 |
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4 |
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4 |
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1234567890/1234567890 |
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5 |
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5 |
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5 |
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1234567890/1234567890 |
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6 |
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6 |
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6 |
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Total Transaction |
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7 |
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VOID AFTER 5 P.M. EASTERN TIME ON AUGUST 6, 2012
WARRANTS TO PURCHASE COMMON STOCK
MARSHALL EDWARDS, INC.
Each
Warrant, entitles the holder thereof to purchase from Marshall Edwards, Inc., a corporation
incorporated under the laws of the State of Delaware the (Company), subject to the terms and
conditions set forth hereinafter and in the Warrant Agreement, hereinafter more fully described
(the Warrant Agreement) at any time on or before the close of business on August 6, 2012
(Expiration Date), four fully paid and non-assessable shares of Common Stock of the Company, par
value $0.00000002 per share (Common Stock) upon presentation and surrender of this Warrant Certificate, with the instructions for the registration and delivery of Common Stock filled
in, at the stock transfer office in Chicago, Illinois, of Computershare Investor Services, Warrant
Agent of the Company (Warrant Agent) or of its successor warrant agent or, if there be no
successor warrant agent, at the corporate offices of the Company, and upon payment of the Exercise
Price per Warrant (as defined in the Warrant Agreement) and any applicable taxes paid either in
cash, or by certified or official bank check, payable in lawful money of the United States of
America to the order of the Company. The number and kind of securities or other property for which
the Warrants are exercisable are subject to adjustment in certain events, such as mergers, splits,
stock dividends, splits and the like, to prevent dilution.
This Warrant Certificate is subject to all terms, provisions and conditions of the Warrant
Agreement, dated as of August 1, 2007, between the Company and the Warrant Agent, to all of which
terms, provisions and conditions the registered holder of this Warrant Certificate consents by
acceptance hereof. The Warrant Agreement is incorporated herein by reference and made a part hereof
and reference is made to the Warrant Agreement for a full description of the rights, limitations of
rights, obligations, duties and immunities of the Warrant Agent, the Company and the holders of the
Warrant Certificates. Copies of the Warrant Agreement are available for inspection at the stock
transfer office of the Warrant Agent or may be obtained upon written request addressed to the
Company at 140 Wicks Road, North Ryde NSW 2113, Australia, Attn: Secretary.
The Company shall not be required upon the exercise of the Warrants evidenced by this Warrant
Certificate to issue fractions of Warrants, Common Stock or other securities, but shall make
adjustment therefor in cash on the basis of the current market value of any fractional interest as
provided in the Warrant Agreement.
THIS WARRANT AND THE SECURITIES ISSUABLE UPON EXERCISE OF THIS WARRANT HAVE NOT BEEN REGISTERED
WITH THE SECURITIES AMD EXCHANGE COMMISSION THE SECURITIES COMMISSION
OF ANY STATE AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT IN
RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE SECURITIES
ACT), PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO
AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE
REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN ACCORDANCE
WITH APPLICABLE STATE SECURITIES LAWS AND IN THE CASE OF A TRANSACTION EXEMPT FROM REGISTRATION, UNLESS THE COMPANY
HAS RECEIVED AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO IT THAT
SUCH TRANSACTION DOES NOT
REQUIRE REGISTRATION UNDER THE SECURITIES ACT AND SUCH OTHER APPLICABLE LAWS.
This Warrant Certificate, with or without other Certificates, upon surrender to the Warrant Agent,
any successor warrant agent or, in the absence of any successor warrant agent, at the corporate
offices of the Company, may be exchanged for another Warrant Certificate or Certificates evidencing
in the aggregate the same number of Warrants as the Warrant Certificate or Certificates so
surrendered. If the Warrants evidenced by this Warrant Certificate shall be exercised in part, the
holder hereof shall be entitled to receive upon surrender hereof another Warrant Certificate
Certificates evidencing the number of Warrants not so exercised.
No holder of this Warrant Certificate, as such, shall be entitled to vote, receive dividends or be
deemed the holder of Common Stock or any other securities of the Company which may at any time be
issuable on the exercise hereof for any purpose whatever, nor shall anything contained in the
Warrant Agreement or herein be construed to confer upon the holder of this Warrant Certificate, as
such, any of the rights of a stockholder of the Company or any right to vote for the election of
directors or upon any matter submitted to stockholders at any meeting thereof or give or withhold
consent to any corporate action (whether upon any matter submitted to stockholders at any meeting
thereof, or give or withhold consent to any merger, recapitalization, issuance of stock,
reclassification of stock, change of par value or change of stock to no par value, consolidation,
conveyance or otherwise) or to receive notice of meetings or other
actions affecting stockholders
(except as provided in the Warrant Agreement) or to receive dividends or subscription rights or
otherwise until the Warrants evidenced by this Warrant Certificate shall have been exercised and the Common Stock
purchasable upon the exercise thereof shall have become deliverable as provided in the Warrant
Agreement.
If this Warrant Certificate shall be surrendered for exercise within any period during which the
transfer books for the Companys Common Stock or other class of stock purchasable upon the exercise
of the Warrants evidenced by this Warrant Certificate are closed for any purpose, the Company shall
not be required to make delivery of certificates for shares purchasable upon such transfer until
the date of the reopening of said transfer books.
Every holder of this Warrant Certificate by accepting the same consents and agrees with the
Company, the Warrant Agent, and with every other holder of a Warrant Certificate that:
(a) |
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this Warrant Certificate is transferable on the registry books of the Warrant Agent only upon
the terms and conditions set forth in the Warrant Agreement, and |
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(b) |
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the Company and the Warrant Agent may deem and treat the person in whose name this Warrant
Certificate is registered as the absolute owner hereof
(notwithstanding any rotation of
ownership or other writing thereon made by anyone other than the Company or the Warrant Agent) for
all purposes whatever and neither the Company nor the Warrant Agent shall be affected by any notice
to the contrary. The Company shall not be required to issue or deliver any certificate for shares
of Common Stock or other securities upon the exercise of Warrants evidenced by this Warrant
Certificate until any tax which may be payable in respect thereof by the holder of this Warrant
Certificate pursuant to the Warrant Agreement shall have been paid, such tax being payable by the
holder of this Warrant Certificate at the time of surrender. |
This Warrant Certificate shall not be valid or obligatory for any purpose until it shall have been
countersigned by the Warrant Agent.
exv23w1
Exhibit 23.1
Marshall Edwards, Inc.
140 Wicks Road
NORTH RYDE NSW 2113
AUSTRALIA
Consent of Independent Registered Public Accounting Firm
We hereby consent to the incorporation by reference in the Registration Statement on Form S-3 (No.
333-136440) of Marshall Edwards, Inc. of our report dated
September 27, 2007, relating to the
consolidated financial statements which appear in this Form 10-K.
BDO Kendalls (NSW)
Sydney, NSW, Australia
September 27, 2007
exv31w1
Exhibit 31.1
CERTIFICATION
I, Christopher Naughton, certify that:
1. |
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I have reviewed this Annual Report on Form 10-K for the year ended June 30, 2007 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. |
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The registrants 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) |
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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 report is
being prepared; |
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(b) |
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Evaluated the effectiveness of the registrants disclosure controls and procedures
and presented in the report our conclusions about the effectiveness of this 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 registrants internal control over
financial reporting that occurred during the registrants fourth fiscal quarter that has
materially affected, or is reasonably likely to materially affect, the registrants
internal control over financial reporting; and |
5. |
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The registrants other certifying officer(s) and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the
audit committee of the registrants board of directors: |
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(a) |
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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 registrants ability to record, process, summarize and report financial information;
and |
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(b) |
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Any fraud, whether or not material, that involves management or other employees who
have a significant role in the registrants internal control over financial reporting. |
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Date: September 27, 2007 |
/s/ Christopher Naughton
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Christopher Naughton |
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Chief Executive Officer |
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exv31w2
Exhibit 31.2
CERTIFICATION
I, David Ross Seaton, certify that:
1. |
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I have reviewed this Annual Report on Form 10-K for the year ended June 30, 2007 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. |
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The registrants 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) |
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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 report is
being prepared: |
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(b) |
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Evaluated the effectiveness of the registrants disclosure controls and procedures
and presented in the report our conclusions about the effectiveness of this 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 registrants internal control over
financial reporting that occurred during the registrants fourth fiscal quarter that has
materially affected, or is reasonably likely to materially affect, the registrants
internal control over financial reporting; and |
5. |
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The Companys other certifying officer(s) and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the
audit committee of the registrants board of directors: |
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(a) |
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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 registrants ability to record, process, summarize and report financial information;
and |
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(b) |
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Any fraud, whether or not material, that involves management or other employees who
have a significant role in the registrants internal control over financial reporting. |
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Date: September 27, 2007 |
/s/ David Seaton
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David R. Seaton |
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Chief Financial Officer |
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exv32w1
Exhibit 32.1
CERTIFICATION
Each of the undersigned hereby certifies, for the purposes of Section 1350 of Chapter 63 of Title
18 of the United States Code, as adopted pursuant o Section 906 of the Sarbanes-Oxley Act of 2002,
in his capacity as an officer of Marshall Edwards, Inc. (Marshall Edwards) that, to his
knowledge, this Annual Report of Marshall Edwards on Form 10-K for the period ended June 30, 2007,
fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange
Act of 1934, as amended, and that the information contained in such a report fairly presents, in
all material respects, the financial condition and results of operation of Marshall Edwards.
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/s/ CHRISTOPHER NAUGHTON
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/s/ DAVID SEATON |
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Christopher Naughton
|
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David R. Seaton |
Chief Executive Officer
|
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Chief Financial Officer |
A signed original of this written statement required by Section 906 has been provided to Marshall
Edwards and will be retained by Marshall Edwards and furnished to the Securities and Exchange
Commission or its staff upon request.