S-3/A
As
filed with the Securities and Exchange Commission on September 5, 2006
Registration
No. 333-136440
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
PRE-EFFECTIVE
AMENDMENT NO. 1 TO
FORM S-3
REGISTRATION STATEMENT
Under the Securities Act of 1933
MARSHALL EDWARDS, INC.
(Exact name of Registrant as specified in its charter)
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DELAWARE
(State or other jurisdiction of
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51-0407811
(I.R.S. Employer |
incorporation or organization)
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Identification Number) |
140 Wicks Road
North Ryde NSW 2113 Australia
(011) 61 2 8877 6196
(Address, including zip code and telephone number, including area code, of registrants principal executive offices)
The Corporation Trust Company
The Corporation Trust Center
1209 Orange Street
Wilmington, Delaware 19801
(302) 658-7581
(Name, address, including zip code, and telephone number, including area code of agent for service)
with copies to:
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Christopher Naughton |
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President & Chief Executive Officer
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Steven A. Navarro, Esq. |
Marshall Edwards, Inc.
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Morgan, Lewis & Bockius LLP |
140 Wicks Road
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101 Park Avenue |
North Ryde NSW 2113 Australia
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New York, New York 10178 |
(011) 61 2 8877 6196
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(212) 309-6000 |
Approximate date of commencement of proposed sale to the public: From time to time after this
Registration Statement becomes effective.
If the only securities being registered on this form are being offered pursuant to dividend or
interest reinvestment plans, please check the following box. o
If any of the securities being registered on this form are to be offered on a delayed or continuous
basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in
connection with dividend or interest reinvestment plans, check the following box þ
If this form is filed to register additional securities for an offering pursuant to Rule 462(b)
under the Securities Act
of 1933, please check the following box and list the Securities Act registration statement number
of the earlier effective registration statement for the same offering. o
If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act
of 1933, check the following box and list the Securities Act registration statement number of the
earlier effective registration statement for the same offering. o
If this Form is a registration statement pursuant to General Instruction I.D. or a post-effective
amendment thereto that shall become effective upon filing with the Securities and Exchange
Commission pursuant to Rule 462(e) under the Securities Act, check the following box. o
If this Form is a post-effective amendment to a registration statement filed pursuant to General
Instruction I.D. filed to register additional securities or additional classes of securities
pursuant to Rule 413(b) under the Securities Act, check the following box. o
The registrant hereby amends this registration statement on such date or dates as may be necessary
to delay its effective date until the registrant shall file a further amendment which specifically
states that this registration statement shall thereafter become effective in accordance with
Section 8(a) of the Securities Act of 1933 or until the registration statement shall become
effective on such date as the Securities and Exchange Commission, acting pursuant to said Section
8(a), may determine.
The information in this prospectus is not complete and may be changed. The selling
stockholders may not sell these securities until the registration statement filed with the
Securities and Exchange Commission is effective. This prospectus is not an offer to sell these
securities and is not soliciting an offer to buy these securities in any state where the offer or
sale is not permitted.
PROSPECTUS
SUBJECT
TO COMPLETION, DATED SEPTEMBER 5, 2006
MARSHALL EDWARDS, INC.
9,268,195 Shares of Common Stock
Common Stock
This prospectus covers 9,268,195 shares of our common stock that may be offered for
resale by the selling stockholders named in this prospectus and the persons to whom such selling
stockholders may transfer their shares. No securities are being offered or sold by us pursuant to
this prospectus. The selling stockholders acquired the common stock and the warrants to purchase
common stock directly from us in transactions exempt from the registration requirements of federal
and state securities laws. We will not receive any of the proceeds from the sale of these shares
by the selling stockholders, but we will receive proceeds from the exercise of warrants, if any,
are exercised for cash.
Our common stock is quoted on the Nasdaq Global Market under the symbol MSHL. The last
reported sale price of our common stock on the Nasdaq Global Market on August 8, 2006 was $2.80 per
share.
The selling stockholders may sell their shares from time to time on the Nasdaq Global
Market or otherwise, in one or more transactions at fixed prices, at prevailing market prices at
the time of sale or at prices negotiated with purchasers. The selling stockholders will be
responsible for any commissions or discounts due to brokers or dealers. We will pay all fees and
expenses incident to the registration of the shares covered by this prospectus.
INVESTING IN OUR COMMON STOCK INVOLVES RISK. SEE RISK FACTORS BEGINNING ON PAGE 5 AS
WELL AS THE RISKS DISCUSSED UNDER THE CAPTION RISK FACTORS IN DOCUMENTS WE SUBSEQUENTLY FILE WITH
THE SECURITIES AND EXCHANGE COMMISSION.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS
APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS PROSPECTUS IS TRUTHFUL OR
COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
The date of this
prospectus is , 2006.
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
Unless we have indicated otherwise, references in this prospectus to Marshall Edwards, we,
us and our or similar terms are to Marshall Edwards, Inc., a Delaware corporation, and its
consolidated subsidiary, Marshall Edwards Pty Limited. References in this prospectus to Novogen
refer to Novogen Limited and its consolidated subsidiaries, other than Marshall Edwards, Inc. and
its subsidiary.
You should rely only on the information contained or incorporated by reference in this
prospectus and in any prospectus supplement. We have not authorized any person to provide any
information or make any statement that differs from what is contained in this prospectus. If any
person does make a statement that differs from what is in this prospectus, you should not rely on
it. This prospectus is not an offer to sell, nor is it a solicitation of an offer to buy, these
securities in any state in which the offer or sale is not permitted. The information in this
prospectus is accurate as of its date, but the information may change after that date. You should
not assume that the information in this prospectus is accurate as of any date after its date.
SUMMARY
This prospectus is part of a registration statement that we filed with the Securities and
Exchange Commission, or SEC, utilizing a shelf registration statement. The selling stockholders
may from time to time sell their shares of our common stock in one or more transactions. This
prospectus provides you with a general description of the common stock being offered. You should
read this prospectus, including all documents incorporated herein by reference, together with
additional information described under the heading Where You Can Find More Information.
The registration statement that contains this prospectus, including the exhibits to the
registration statement, contains additional information about us and the securities being offered
under this prospectus. You should read the registration statement and the accompanying exhibits
for further information. The registration statement and exhibits can be read and are available to
the public over the Internet at the SECs website at http: //www.sec.gov.
Company Overview
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, an Australian company. Novogens ordinary shares
trade on the Australian Stock Exchange under the symbol NRT, and American Depositary Receipts
(ADRs) trade in the United States under the symbol NVGN on the Nasdaq Global Market. Novogen
currently owns approximately 78.1% 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.
Pre-clinical testing has shown phenoxodiol to have broad anti-cancer action against an
extensive library of human cancer cell lines, including prostate, ovarian and squamous cell
carcinoma. Phenoxodiol commenced Phase I clinical studies in Australia in 2000 and currently is
undergoing a Phase Ib/IIa clinical trial (intravenous dosage form) in the United States and
Australia in patients with refractory ovarian cancer, a Phase Ib study (oral dosage form) in
Australia in patients with hormone-refractory prostate cancer (prostate cancer that grows and is
not inhibited by hormone therapy), a Phase Ib study (oral dosage form) in the United States in
patients with cervical cancer and a Phase I study (oral dose form) in Australia in patients with
renal carcinoma. 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. In
2005, the FDA granted phenoxodiol Fast Track status for its intended use in patients with
hormone-refractory prostate cancer.
In May 2006, we completed a Special Protocol Assessment (SPA) and reached agreement with
the FDA on a pivotal Phase III study of phenoxodiol 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). 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 a binding agreement 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 by the FDA of the marketing application for this
indication.
In May 2006, we and Novogen entered into a licence agreement pursuant to which Novogen granted
to us, through Marshall Edwards Pty Limited, an exclusive, worldwide non-transferable license under
its patent and patent applications and in its know how to conduct clinical trials, commercialize
and distribute the anti-cancer drug candidates, NV-196 and NV-143.
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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 anticancer/chemo-sensitizing effect.
NV-143 is initially being developed to target the treatment of melanoma.
Recent Developments
Private Placement
On July 11, 2006, 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 consists of one share of common stock and .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
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.
Standby Equity Distribution Agreement with Cornell Capital Partners, LP.
On July 11, 2006 we entered into a standby equity distribution agreement, which we refer to as
the SEDA, with Cornell Capital Partners, LP. 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. 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 our 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.
In connection with the SEDA, we paid Cornell a commitment fee of 123,626 shares of our common
stock and warrants to purchase 600,000 shares of our common stock that expire on July 11, 2010.
The warrants have an exercise price of $4.35 per share, subject to certain adjustments.
The purchase price for shares of our common stock under the SEDA will be equal to 97% of the
lowest volume weighted average price as quoted by Bloomberg, LP, or VWAP, of shares of our common
stock (subject to a minimum acceptable price as described below) during the five consecutive
trading days after we send notice to Cornell of our intention to sell them shares of our common
stock, which we refer to as the pricing period.
The minimum acceptable price at which we may sell shares of our common stock, unless we waive
(in our sole discretion) the minimum acceptable price, is no less than 97% of the VWAP for our
shares of common stock on the trading day immediately preceding the date we send notice to Cornell
of our intent to sell shares of our common stock. For any day in the pricing period when the VWAP
is less than the minimum acceptable price, (i) that days VWAP will be excluded from the pricing
mechanism during the pricing period; (ii) we will automatically reduce the amount of the funds
covered by the advance notice by 20%; and (iii) the number shares of our common stock to be sold to
Cornell (stated in the advance notice) will be reduced proportionately.
Before we can sell any shares of our common stock to Cornell under the SEDA, a resale
registration statement will have to be filed with and declared effective by the SEC to cover
Cornells resale of shares of our common stock it buys under the SEDA. The shares of our common
stock eligible to be sold under the SEDA have not been registered pursuant to the registration
statement of which this prospectus forms a part.
The number of shares of our common stock that we can issue to Cornell is limited by
Nasdaqs Market Place Rule 4350(i)(1)(D) the 20% rule: All of the shares of our common stock
that could be issued in connection with the SEDA, the other securities issued as a commitment fee
in connection with the SEDA and the shares of our
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common stock issued in connection with the private placement described above, cannot exceed 20% of
the shares outstanding. We have determined that currently we could issue and sell all of the
shares of our common stock subject to the SEDA. If circumstances change, however, we may need to
obtain shareholder approval to waive the 20% rule.
While the SEDA provides the Company access to significant equity financing, using the SEDA at
low market prices could result in dilution to current shareholders, and also may have a depressing
effect on our stock price. See Risks Related to the Cornell Transaction.
Securities Offered
We are registering for resale by the selling stockholders 6,452,937 shares of our common
stock initially acquired directly from us in transactions exempt from the registration requirements
of federal and state securities laws. In addition, we are registering for resale 2,815,258 shares
of our common stock issuable upon exercise of warrants outstanding on the date hereof, as may be
amended from time to time. We are also registering for resale any additional shares of common
stock which may become issuable with respect to the shares of common stock issued by reason of any
stock dividend, stock split, recapitalization or other similar transaction effected without the
receipt of consideration, which results in an increase in the number of outstanding shares of our
common stock.
Our Address and Telephone Number
Our principal executive office is located at 140 Wicks Road, North Ryde NSW 2113, Australia,
and our telephone number is 011 61 2 8877 6196. Our Internet website address is
http://www.marshalledwardsinc.com. The information contained on our website shall not be deemed to
constitute a part of this prospectus.
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RISK FACTORS
An investment in our common stock involves a high degree of risk. You should carefully
consider the risks described below, together with all other information contained in this
prospectus before deciding to purchase our common stock. If any of the following risks actually
occur, our business, financial condition or operating results may be harmed. In that case, the
trading price of our common stock may decline, and you may lose part or all of your investment in
our common stock.
Risks Related to Our Business
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 $25,501,000 since our
inception, including net losses of $7,386,000, $6,421,000 and
$8,538,000 for the years ended June 30, 2006,
2005 and 2004, 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 expect to expand our
clinical trials significantly, which will result in increasing losses, and may continue to incur
substantial losses even if we begin to generate revenues from the distribution and sale of
phenoxodiol.
If we are unable to successfully develop and commercialize phenoxodiol or our newly licensed
anti-cancer compounds NV-196 and NV-143, or license other viable drug candidates, our ability to
sustain future operations will be significantly diminished.
Under our license option deed
with Novogen, we acquired a license from Novogen to develop anti-cancer drugs containing the drug
candidates NV-196 and NV-143. We cannot guarantee that phenoxodiol will be successful or that we
will develop successful anti-cancer drugs containing NV-196 and NV-143. Our rights under our
license agreement for phenoxodiol and our license agreement for NV-196 and NV-143 with Novogen are
limited to the commercialization of phenoxodiol, NV-196 and NV-143 as anti-cancer agents and these
rights specifically exclude the use of phenoxodiol, NV-196 and NV-143 in topical applications. If
we are unable to successfully develop and commercialize phenoxodiol or other viable anti-cancer
drug candidates containing NV-196 or NV-143, we may be required to cease or reduce our operations.
If the data from our clinical trials 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. In 2005, the FDA granted
phenoxodiol Fast Track status for its intended use in patients with hormone-refractory prostate
cancer (prostate cancer that grows and is no longer inhibited by hormone therapy). More recently
we completed a Special Protocol Assessment (SPA) and reached agreement with the FDA on a pivotal
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). 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. As a fast track product, phenoxodiol
will be eligible for accelerated approval and priority review by the FDA of the marketing
application for this indication. If the FDA concludes that the data from our pivotal clinical
trial have failed to demonstrate the safety and effectiveness of phenoxodiol, we will not receive
FDA approval to market phenoxodiol for those indications in the United States. We cannot assure
you that the results of our Phase III pivotal trial will be successful.
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
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phenoxodiol will be impaired and we may be required to cease or reduce our operations.
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.
Docetaxel, a drug distributed by Aventis, was approved in 2004 by the FDA for the treatment of
hormone-refractory prostate cancer, establishing a new bench-mark for standard chemotherapy in
late-stage prostate cancer. We do not believe docetaxel is a direct competitor of our use of
phenoxodiol for late-stage prostate cancer because our strategy is to develop phenoxodiol as a
chemosensitizer for docetaxel in patients with prostate cancer who become resistant to docetaxel.
A number of pharmaceutical and biotechnology companies are known to be seeking to develop drugs for
the same indication.
The experimental drug, Telcyta, manufactured by Telik, Inc., is a directly competitive drug to our
use of phenoxodiol as a chemo-sensitizing agent to restore sensitivity to platinum-based drugs in
late-stage ovarian cancer. Telcyta currently is in a Phase III registration trial suggesting that
it has shown sufficient promise in a Phase II study to warrant progression to a Phase III study.
The different study protocols being used by us with phenoxodiol and by Telik, Inc. with Telcyta
make it difficult to compare the two drugs for efficacy in this area and, as a result, we cannot
evaluate the level of competition. However, we expect that at any level of efficacy, Telcyta,
should it be approved for marketing, would represent a serious competitor for phenoxodiol.
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 oncologic 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 may not complete our pivotal trials on schedule, or at all, or they may be conducted improperly,
which may delay or preclude FDA marketing approval.
The completion of our pivotal trials may be delayed or terminated for many reasons, including, but
not limited to, if:
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subjects do not enroll in our pivotal trials at the rate we currently expect; |
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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 perform our pivotal trial on our anticipated
schedule or consistent with the clinical trial protocol, 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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inspections of our clinical trial sites by the FDA or Institutional Review Boards,
(IRBs), find regulatory violations that require us to undertake corrective action, suspend
or terminate one or more sites, or prohibit us from using some or all of the data in
support of our marketing applications; |
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one or more IRB suspends or terminates the trial at an investigational site, precludes
enrollment 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 development costs will increase if we have material delays in our pivotal trials, or if we are
required to modify, suspend, terminate or repeat a pivotal trial.
We will need to raise additional funds to complete clinical trials and commercialize NV-196 and
NV-143, and the actual amount of funds we will need will be determined by a number of factors, some
of which are beyond our control.
While we believe that we have sufficient funds to complete our current clinical trial program, we
will require additional funds to further the evaluation of NV-196 and NV-143 beyond the current
objectives. The actual amount of funds that we will need will be determined by many factors, some
of which are beyond our control. As a result, we may need additional funds sooner than we
currently anticipate. These factors include:
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the progress of research activities, the number and scope of research programs; |
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the progress of pre-clinical and clinical development activities; |
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the progress of the development efforts of Novogen or any other parties with whom we
enter into research and development agreements; |
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our ability to establish and maintain current and new research and development and
licensing arrangements; |
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our ability to achieve milestones under licensing arrangements; and |
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the costs involved in enforcing or defending patent claims and other intellectual
property rights; and the costs and timing of regulatory approvals. |
If our capital resources are insufficient to meet future capital requirements, we will have to
raise additional funds. If we are unable to obtain additional funds on favorable 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 have not yet submitted an investigational new drug application (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 the first Phase I clinical trial 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: (1) adequate information on the safety and manufacturing of NV-196 or
NV-143 to assure the proper quality, purity and strength of the investigational product, (2)
summary of pharmacological and toxicological effects, pharmacokinetics (how the drug is absorbed
and metabolized) and biological disposition in animals, (3) the proposed protocol for any planned
clinical study, and (4) 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.
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.
While we have not previously experienced problems with third parties upon whom we rely for
research or clinical trials, our reliance upon research institutions, including hospitals and
cancer clinics, provides us with less control over the timing and
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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.
Our ability to achieve profitability is dependent on a number of factors, many of which have
uncertain outcomes.
Our ability to achieve profitability is dependent on a number of factors including:
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completing our clinical trial program and receiving marketing approval. Clinical
testing is a prerequisite to the receipt of the regulatory approval necessary to
commercialize our product candidates. We cannot control the outcome of our testing program
or whether we receive regulatory approval. We will not be able to generate sales revenues
until we receive marketing approval; |
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establishing strategic partnerships to market and sell our product candidates. Our
negotiating position with potential strategic partners will be affected by the success of
our clinical program. If we are unable to attract partners and negotiate favorable terms,
we may have difficulty generating revenues from our commercialization of our product
candidates; |
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identifying manufacturing partners with a low cost operation and scalable supply capable
of meeting the demands of the commercial market for our product candidates. We have
contracted with third parties for the supply of phenoxodiol for our pivotal study and to
develop a scalable manufacturing process. We will need to rely on Novogen or third party
manufacturers to supply NV-196 and NV-143. We do not have direct control over the
manufacturing costs of phenoxodiol, NV-196 and NV-143. If our costs for the supply of
phenoxodiol, NV-196 or NV-143 rise or if our contractors fail to supply sufficient
quantities of phenoxodiol, NV-196 and NV-143, our profitability could be adversely
affected; and |
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our ability to license from Novogen rights to commercialize new cancer compounds. We
may license from Novogen the rights to other cancer compounds under the terms of the
license option deed. If development of phenoxodiol is unsuccessful or if we choose to
expand to the development of additional compounds, our success may depend on controlling
the costs of developing such new compounds and negotiating a favorable license agreement
with Novogen. The availability of new compounds to commercialize and the cost to develop
these compounds is outside of our direct control. |
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, which currently provides phenoxodiol for use in clinical
trials, has taken the strategic decision not to manufacture on a large scale Active Pharmaceutical
Ingredients (APIs) for cancer drugs, including phenoxodiol, as these can be more economically
supplied by third parties with particular expertise in this area. The contract facilities that
have been identified are FDA licensed, have a track record of large scale APIs manufacture and
have already invested in capital and equipment. We completed the
novation to MEPL of contracts that Novogen had entered into with
third parties to develop a scalable manufacturing method to ensure that sufficient quantities of
phenoxodiol can be manufactured in compliance with cGMP (Current Good Manufacturing Practices) and
to complete the analytical and stability work necessary for an NDA submission. 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.
8
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.
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 may not be able to establish the strategic partnerships necessary to 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 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 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 $14 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
9
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 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 become the subject of certain bankruptcy proceedings or
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. Under the
manufacturing license and supply agreement, we have granted to Novogen an exclusive sub-license to
manufacture and supply phenoxodiol to us in its primary manufactured form and Novogen has agreed to
manufacture for us our required quantities of phenoxodiol. This agreement enables us to protect
the licensed intellectual property rights used in the manufacturing process while securing the
services of a manufacturing partner in Novogen, which through its equity position in us, shares a
common interest in the production of phenoxodiol. 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 complimentary 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.
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
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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 notice of
allowance 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 chemical additives intended 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.
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
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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.
All 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 our
officers and directors or to enforce judgments obtained against our officers and directors or us in
United States courts.
Our revenue is 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 78.1% 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.
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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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delaying, deferring or preventing a change in control; |
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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.
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 Graham Kelly, our Chairman and Phenoxodiol Program Director,
Professor Alan Husband, Novogen Research Director, and Mr. Christopher Naughton, our President and
CEO, 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 and maintains key man life insurance policies for each of these
persons.
The ongoing criminal investigations involving Professor Kelly, our Chairman and Phenoxodiol Program
Director, could have a material adverse effect on our business or cause our stock price to decline.
Professor Kelly is one of a number of individuals who, and whose associated entities and advisors,
have been the subject of investigations by certain Australian authorities relative to their alleged
involvement in the evasion of Australian tax, fraud and money laundering. Professor Kelly has
informed us that he does not believe that he has committed any wrongdoing and denies that he has
been involved in any wrongdoing. Nevertheless, Professor Kelly may need to allocate time and
resources to deal with the investigation. Additionally, if the Australian authorities were to
decide to prosecute Professor Kelly upon concluding their investigation and if such prosecution
were to result in a conviction, Professor Kelly may be barred from acting as an officer or director
and may become unavailable to us. Any publicity related to this investigation or potential
prosecution or conviction of Professor Kelly could have a material adverse effect on our business
or cause our stock price to decline.
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-
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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, including in connection
with our SEDA. |
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.
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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 including the shares in connection with our SEDA, or the
perception that these sales could occur. Stockholders could also experience dilution in their
investment if we sell shares to Cornell under the SEDA at a price which is less than our net
tangible book value per share. The selling stockholders named herein will be able to sell their
shares of common stock covered by this registration statement freely in the public market place. A
depressed stock price could make it more difficult for us to raise funds through future equity
offerings. As of August 1, 2006, we had 63,390,937 shares of our common stock outstanding not
including the 5,207,258 shares of common stock underlying warrants.
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.
Risks Related to the Private Placement
If we fail to obtain and 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 connection with the securities subscription agreement we entered into with certain accredited
investors as of July 11, 2006, we entered into a registration rights agreement pursuant to which we
are 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. We filed the registration statement on August 9, 2006.
In the event that the registration statement 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 regains its effectiveness 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, shares of common stock
issuable upon exercise of warrants or 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.
Risks Related to the Cornell Transaction
If
we sell shares of our stock to Cornell under the SEDA, Cornell will pay less than the market price and this incentive to sell our shares could cause our
stock price to decline.
Because Cornell will purchase shares of our stock through the SEDA at a discount to market price,
Cornell will have an incentive to immediately sell the shares it purchases, to realize a gain on
the difference between the purchase price and the then-prevailing market price of our common stock.
These sales may result in a decrease in our stock price. Cornell is deemed to beneficially own
the shares corresponding to a particular advance on the date that we deliver an advance notice to
Cornell, which is prior to the date the shares are delivered to Cornell. Cornell may sell such
shares any time after we deliver an advance notice, and its sales during the pricing period could
cause our price to decline. Even with the SEDAs price floor (the minimum acceptable price of 97%
of VWAP on the day before
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we send an advance notice), Cornells sales could adversely impact share price by as much as three
percent or more if we waive the minimum acceptable price provision.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus includes forward-looking statements. All statements other than statements of
historical facts contained in this prospectus, including statements regarding our 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 our current expectations and projections about future events and financial trends that
we believe may affect our financial condition, results of operations, business strategy and
financial needs. These forward-looking statements are subject to a number of risks, uncertainties
and assumptions described in Risk Factors and elsewhere in this prospectus, including, among
other things:
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our limited operating history; |
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our inability to obtain any additional required financing or financing available to us on acceptable terms; |
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our failure to successfully commercialize our product candidates; |
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costs and delays in the development and/or receipt of FDA or other required governmental
approvals, or the failure to obtain such approvals, for our product candidates; |
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uncertainties in clinical trial results; |
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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, 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 defense 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 prospectus may include additional
factors which
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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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USE OF PROCEEDS
We will not receive any proceeds from the sale of the shares of common stock offered by
the selling stockholders. We will receive proceeds from the exercise of the warrants, if they are
exercised for cash, rather than on a cashless basis. If the warrants are fully exercised for cash,
we will receive aggregate gross proceeds of approximately $12,246,372. The exercise price and
number of shares of common stock issuable upon exercise of the warrants may be adjusted in certain
circumstances including stock splits, dividends, reclassifications, corporate reorganizations,
mergers or liquidations. 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.
19
SELLING STOCKHOLDERS
The following table provides information regarding the selling stockholders and the
number of shares of common stock they are offering, which includes shares issuable upon exercise of
warrants held by the selling stockholders. Under the rules of the SEC, beneficial ownership
includes shares over which the indicated beneficial owner exercises voting or investment power.
Shares of common stock subject to warrants that are currently exercisable or will become
exercisable within 60 days are deemed outstanding for computing the percentage ownership of the
person holding the warrants but are not deemed outstanding for computing the percentage ownership
of any other person.
Unless otherwise indicated in the footnotes below, we believe that the persons and
entities named in the table have sole voting and investment power with respect to all shares
beneficially owned. The information regarding shares beneficially owned after the offering assumes
the sale of all shares offered by each of the selling stockholders. The percentage ownership data
is based on 63,390,937 shares of our common stock issued and outstanding as of August 1, 2006,
which includes 6,452,937 shares of our common stock covered by this prospectus.
The shares of common stock covered by this prospectus may be sold by the selling
stockholders, by those persons or entities to whom they transfer, donate, devise, pledge or
distribute their shares or by other successors in interest. We are registering the shares of our
common stock for resale by the selling stockholders. None of the selling stockholders has had any
position, office or other material relationship with us or any of our affiliates within the past
three years, other than as a stockholder. The shares are being registered to permit public
secondary trading of the shares, and the selling stockholders may offer the shares for resale from
time to time.
Effective July 11, 2006, pursuant to a securities subscription agreement, we issued and
sold 6,329,311 shares of our common stock and warrants exercisable for up to 2,215,258 additional
shares of our common stock. The common stock and warrants were sold at a price of $2.90 per unit in
a private placement transaction for aggregate cash proceeds to us of $17,178,702. Each unit
consists of one share of common stock and .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. All
warrants have a term of four years, are fully exercisable six months from the date of issuance and
include cashless net exercise provisions. 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. Effective July 11, 2006, pursuant to a Standby Equity Distribution
Agreement with Cornell Capital Partners, LP, we issued to Cornell Capital 123,626 shares of common
stock and warrants to purchase 600,000 shares of our common stock as a commitment fee. The
warrants are on the same terms as the warrants issued in the private placement above.
All of the selling stockholders acquired the common stock and warrants to purchase common
stock to which this prospectus relates directly from us in transactions exempt from the
registration requirements of the federal and state securities laws. Prior to issuance, each offeree
and selling security holder represented to us that it was an accredited investor, as defined in
Rule 501 of Regulation D pursuant to the Securities Act of 1933, as amended (the Securities Act),
and that each was acquiring the securities for investment purposes only and not with a view to, or
for sale in connection with, any distribution thereof. All of the securities were issued solely to
accredited investors, as defined in Rule 501 of Regulation D pursuant to the Securities Act.
In connection with the private placement, we agreed to file the registration statement of
which this prospectus forms a part with the SEC covering the resale of the offered shares. We also
agreed to prepare and file all amendments and supplements necessary to keep the registration
statement continuously effective under the Securities Act until all of the offered shares covered
by the registration statement have been sold or may be sold without volume restrictions pursuant to
Rule 144.
The following table sets forth information with respect to the selling stockholders and
the shares of common stock (which includes shares of common stock underlying warrants) beneficially
owned by each selling stockholder that may be offered under this prospectus. The information is
based on information provided by or on behalf of the selling stockholders to us and is as of the
date of this prospectus. Because the selling stockholders may offer all or some portion of the
common stock, no estimate can be given as to the amount of the common stock that will be held by
the selling stockholders upon termination of this offering. For purposes of the table below,
however, we have assumed that after termination of this offering none of the shares covered by this
prospectus will be held by
20
the selling stockholders. The number of shares of common stock included in the
column below entitled Shares Beneficially Owned Before Offering Number, includes shares of
common stock issuable upon exercise of warrants issued in connection with the securities
subscription agreement we entered into effective July 11, 2006. The warrants are not exercisable
until January 11, 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares Beneficially |
|
Number of |
|
Shares Beneficially |
|
|
Owned Before Offering |
|
Shares Being Offered |
|
Owned After Offering |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
Underlying |
|
|
|
|
Name |
|
Number* |
|
%** |
|
Issued |
|
Warrants |
|
Number |
|
%** |
Cranshire Capital, LP |
|
|
93,104 |
(1) |
|
|
* |
** |
|
|
68,966 |
|
|
|
24,138 |
|
|
|
|
|
|
|
* |
** |
El Coronado Holdings, LLC |
|
|
2,851,794 |
(2) |
|
|
4.5 |
% |
|
|
1,500,000 |
|
|
|
525,000 |
|
|
|
826,794 |
|
|
|
1.3 |
% |
Alpha Capital Anstalt |
|
|
139,655 |
(3) |
|
|
* |
** |
|
|
103,448 |
|
|
|
36,207 |
|
|
|
|
|
|
|
* |
** |
Kingsford Capital
Partners, LP |
|
|
64,604 |
(4) |
|
|
* |
** |
|
|
47,855 |
|
|
|
16,749 |
|
|
|
|
|
|
|
* |
** |
Kingsford International,
Ltd |
|
|
233,716 |
(5) |
|
|
* |
** |
|
|
173,123 |
|
|
|
60,593 |
|
|
|
|
|
|
|
* |
** |
Kingsford Capital
Masterpiece, Ltd |
|
|
39,180 |
(6) |
|
|
* |
** |
|
|
29,022 |
|
|
|
10,158 |
|
|
|
|
|
|
|
* |
** |
Accipiter Life Sciences
Fund (Offshore), Ltd. |
|
|
405,876 |
(7) |
|
|
* |
** |
|
|
300,649 |
|
|
|
105,227 |
|
|
|
|
|
|
|
* |
** |
Accipiter Life Sciences
Fund, LP |
|
|
408,780 |
(8) |
|
|
* |
** |
|
|
302,800 |
|
|
|
105,980 |
|
|
|
|
|
|
|
* |
** |
Gerlach & Co |
|
|
58,187 |
(9) |
|
|
* |
** |
|
|
19,800 |
|
|
|
6,930 |
|
|
|
31,457 |
|
|
|
* |
** |
Ell & Co |
|
|
280,245 |
(10) |
|
|
* |
** |
|
|
138,700 |
|
|
|
48,545 |
|
|
|
93,000 |
|
|
|
* |
** |
Hare & Co |
|
|
1,809,285 |
(11) |
|
|
2.9 |
% |
|
|
278,300 |
|
|
|
97,405 |
|
|
|
1,433,580 |
|
|
|
2.3 |
% |
Kane & Co |
|
|
555,060 |
(12) |
|
|
* |
** |
|
|
255,600 |
|
|
|
89,460 |
|
|
|
210,000 |
|
|
|
* |
** |
Kane & Co |
|
|
3,088,104 |
(13) |
|
|
4.9 |
% |
|
|
1,015,438 |
|
|
|
355,403 |
|
|
|
1,717,263 |
|
|
|
2.7 |
% |
Gerlach & Co |
|
|
38,695 |
(14) |
|
|
* |
** |
|
|
16,300 |
|
|
|
5,705 |
|
|
|
16,690 |
|
|
|
* |
** |
Steven Shulman |
|
|
65,352 |
(15) |
|
|
* |
** |
|
|
34,483 |
|
|
|
12,069 |
|
|
|
18,800 |
(16) |
|
|
* |
** |
Mark Umbach |
|
|
66,552 |
(17) |
|
|
* |
** |
|
|
34,483 |
|
|
|
12,069 |
|
|
|
20,000 |
|
|
|
* |
** |
Karl Kuechenmeister |
|
|
104,814 |
(18) |
|
|
* |
** |
|
|
34,483 |
|
|
|
12,069 |
|
|
|
58,262 |
(19) |
|
|
* |
** |
Donald L. Moran Revocable
Living Trust, 6/30/04 |
|
|
23,275 |
(20) |
|
|
* |
** |
|
|
17,241 |
|
|
|
6,034 |
|
|
|
|
|
|
|
* |
** |
Dr. Alan Schreiber and
Pamela Schreiber JTWROS |
|
|
41,875 |
(21) |
|
|
* |
** |
|
|
17,241 |
|
|
|
6,034 |
|
|
|
18,600 |
(22) |
|
|
* |
** |
Richard Dickie |
|
|
48,275 |
(23) |
|
|
* |
** |
|
|
17,241 |
|
|
|
6,034 |
|
|
|
25,000 |
(24) |
|
|
* |
** |
Frederick K. Day |
|
|
463,259 |
(25) |
|
|
* |
** |
|
|
172,414 |
|
|
|
60,345 |
|
|
|
230,500 |
(26) |
|
|
* |
** |
Earl F. Slick Revocable
Trust dated 1/17/00 |
|
|
93,104 |
(27) |
|
|
* |
** |
|
|
68,966 |
|
|
|
24,138 |
|
|
|
|
|
|
|
* |
** |
Cornell Capital Partners,
LP |
|
|
2,585,695 |
(28) |
|
|
4.1 |
% |
|
|
1,502,936 |
|
|
|
1,082,759 |
|
|
|
|
|
|
|
* |
** |
Nite Capital, LP |
|
|
139,655 |
(29) |
|
|
* |
** |
|
|
103,448 |
|
|
|
36,207 |
|
|
|
|
|
|
|
* |
** |
Brittany Asset Management |
|
|
292,000 |
(30) |
|
|
* |
** |
|
|
200,000 |
|
|
|
70,000 |
|
|
|
22,000 |
(31) |
|
|
* |
** |
Total |
|
|
13,990,141 |
|
|
|
* |
** |
|
|
6,452,937 |
|
|
|
2,815,258 |
|
|
|
4,721,946 |
|
|
|
* |
** |
|
|
|
* |
|
Includes shares of common stock issuable upon exercise of warrants with an exercise price of
$4.35 per share expiring on July 11, 2010. Such warrants are not exercisable until January 11,
2007. |
|
** |
|
Shares of common stock subject to warrants that are currently exercisable or will become
exercisable within 60 days are deemed outstanding in addition to the 63,390,937 shares of common
stock outstanding as of August 1, 2006 for purposes of computing the percentage ownership of the
person holding the warrants but are not deemed outstanding for computing the percentage ownership
of any other person. As of August 1, 2006, 2,392,000 shares of common stock were subject to
warrants exercisable within 60 days. |
|
*** |
|
Less than 1% |
21
(1) |
|
Includes 24,138 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
The address of Cranshire Capital, LP is 3100 Dundee Road, Suite 703,
Northbridge, Illinois 60062. The affairs of Cranshire Capital are
managed by Downsview Capital, Inc., the General Partner of Cranshire
Capital. The principal who exercises investment control over this
selling stockholder is Mitchell P. Kopin, President of Downsview
Capital. |
|
(2) |
|
Includes 525,000 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
The address of El Coronado Holdings, LLC is 177 N. Church Street,
Suite 1000, Tuscon, Arizona 85701. The principal who exercises
investment control over this selling stockholder is Josiah T. Austin. |
|
(3) |
|
Includes 36,207 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
The address of Alpha Capital Anstalt is Pradafant 7, Furstatums 9490,
Vadus Liechtenstein. The principal who exercises investment control
over this selling stockholder is Konrad Ackermann. |
|
(4) |
|
Includes 16,749 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
The address of Kingsford Capital Partners, LP is 1160 Brickyard Cove
Road, Suite 300, Point Richmond, California 94803. The principal who
exercises investment control over this selling stockholder is
Kingsford Capital Management, LLC. |
|
(5) |
|
Includes 60,593 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
The address of Kingsford International, Ltd is 1160 Brickyard Cove
Road, Suite 300, Point Richmond, California 94803. The principal who
exercises investment control over this selling stockholder is
Kingsford Capital Management, LLC. |
|
(6) |
|
Includes 10,158 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
The address of Kingsford Capital Masterpiece, Ltd is 1160 Brickyard
Cove Road, Suite 300, Point Richmond, California 94803. The
principal who exercises investment control over this selling
stockholder is Kingsford Capital Management, LLC. |
|
(7) |
|
Includes 105,227 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
The address of Accipter Life Sciences Fund (Offshore), Ltd. is 399
Park Avenue, 38th Floor, New York, New York 10022. The principal who
exercises investment control over this selling stockholder is Gabe
Hoffman. |
|
(8) |
|
Includes 105,980 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
The address of Accipter Life Sciences Fund, LP is 399 Park Avenue,
38th Floor, New York, New York 10022. The principal who exercises
investment control over this selling stockholder is Gabe Hoffman. |
|
(9) |
|
Includes 6,930 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
The address of Gerlach & Co is 6803 South Tuscon Way, Centennial,
Colorado 80112. The principal who exercises investment control over
this selling stockholder is George Evans, Senior Vice President of
OTC International Growth Fund, the custodian for this selling
stockholder. |
|
(10) |
|
Includes 48,545 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
The address of Ell & Co is 6803 South Tuscon Way, Centennial,
Colorado 80112. The principal who exercises investment control over
this selling stockholder is George Evans, Senior Vice President of
AZL Oppenheimer International Growth Fund, the custodian for this
selling stockholder. |
|
(11) |
|
Includes 97,405 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
The address of Hare & Co is 6803 South Tuscon Way, Centennial,
Colorado 80112. The principal who exercises investment control over
this selling stockholder is George Evans, Senior Vice President of
Mass Mutual International Equity Fund, the custodian for this selling
stockholder. |
|
(12) |
|
Includes 89,460 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007. |
22
|
|
The address of Kane & Co is 6803 South Tuscon Way, Centennial,
Colorado 80112. The principal who exercises investment control over
this selling stockholder is George Evans, Senior Vice President of
Oppenheimer International Growth Fund/VA, the custodian for this
selling stockholder. |
|
(13) |
|
Includes 355,403 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
The address of Kane & Co is 6803 South Tuscon Way, Centennial,
Colorado 80112. The principal who exercises investment control over
this selling stockholder is George Evans, Senior Vice President of
Oppenheimer International Growth Fund, the custodian for this selling
stockholder. |
|
(14) |
|
Includes 5,705 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
The address of Gerlach & Co is 6803 South Tuscon Way, Centennial,
Colorado 80112. The principal who exercises investment control over
this selling stockholder is George Evans, Senior Vice President of
OFI International Equity Fund, the custodian for this selling
stockholder. |
|
(15) |
|
Includes 12,069 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
Includes 18,800 shares of common stock issuable upon exercise of
warrants with an exercise price of $9.00 per share expiring in
December 2006. |
|
(16) |
|
Includes 18,800 shares of common stock issuable upon exercise of
warrants with an exercise price of $9.00 per share expiring in
December 2006. |
|
(17) |
|
Includes 12,069 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007. |
|
(18) |
|
Includes 12,069 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
Includes 10,000 shares of common stock issuable upon exercise of
warrants with an exercise price of $9.00 per share expiring in
December 2006. |
|
(19) |
|
Includes 10,000 shares of common stock issuable upon exercise of
warrants with an exercise price of $9.00 per share expiring in
December 2006. |
|
(20) |
|
Includes 6,034 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
The address of Donald L. Moran Revocable Living Trust, 6/30/04 is 728
Murrell Drive, Kettering, Ohio 45429. The principal who exercises
investment control over this selling stockholder is Donald L. Moran. |
|
(21) |
|
Includes 6,034 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
Includes 9,300 shares of common stock issuable upon exercise of
warrants with an exercise price of $9.00 per share expiring in
December 2006. The address of Dr. Alan Schreiber and Pamela
Schreiber JTWROS is 821 Westview Street, Philadelphia, Pennsylvania
19119. The principals who exercise investment control over this
selling stockholder are Dr. Alan Schreiber and Pamela Schreiber. |
|
(22) |
|
Includes 9,300 shares of common stock issuable upon exercise of
warrants with an exercise price of $9.00 per share expiring in
December 2006. |
|
(23) |
|
Includes 6,034 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
Includes 15,000 shares of common stock issuable upon exercise of
warrants with an exercise price of $9.00 per share expiring in
December 2006. |
|
(24) |
|
Includes 15,000 shares of common stock issuable upon exercise of
warrants with an exercise price of $9.00 per share expiring in
December 2006. |
|
(25) |
|
Includes 60,345 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
Includes 59,000 shares of common stock issuable upon exercise of
warrants with an exercise price of $9.00 per share expiring in
December 2006. |
|
(26) |
|
Includes 59,000 shares of common stock issuable upon exercise of
warrants with an exercise price of $9.00 per share expiring in
December 2006. |
|
(27) |
|
Includes 24,138 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share expiring on July
11, 2010. Such warrants are not exercisable until January 11, 2007.
The address of Earl F. Slick Revocable Trust dated 1/17/00 is P.O.
Box 5958, Winston-Salem, North Carolina, 27113. The principal who
exercises investment control over this selling stockholder is Earl
Frates Slick. |
|
(28) |
|
Includes 1,082,759 shares of common stock issuable upon exercise of
482,759 warrants issued in |
23
|
|
connection with the private placement and
600,000 warrants issued in connection with the SEDA, all exercisable
at a price of $4.35 per share and expiring on July 11, 2010. Such
warrants are not exercisable until January 11, 2007. Includes
1,502,936 shares of common stock, 1,379,310 shares issued in
connection with the private placement and 123,626 shares issued in
connection with the SEDA. The address of Cornell Capital Partners,
L.P. is 101 Hudson Street, Suite 3606, Jersey City, New Jersey 07302.
The principal who exercises investment control over this selling
stockholder is Mark Angelo. |
|
(29) |
|
Includes 36,207 shares of common stock issuable upon exercise of
warrants at an exercise price of $4.35 per share expiring on July 11,
2010. Such warrants are not exercisable until January 11, 2007. The
address of Nite Capital, LP is 100 East Cook Avenue, Suite 201,
Libertyville, Illinois 80048. The principal who exercises investment
control over this selling stockholder is Keith Goodman. Mr. Goodman
disclaims beneficial ownership of the shares held by Nite Capital,
LP. |
|
(30) |
|
Includes 70,000 shares of common stock issuable upon exercise of
warrants with an exercise price of $4.35 per share and expiring on
July 11, 2010. Such warrants are not exercisable until January 11,
2007. Includes 11,000 shares of common stock issuable upon exercise
of warrants with an exercise price of $9.00 per share expiring in
December 2006. The address of Brittany Asset Management is 8585 Old
Cutler Road, Coral Gables, Florida 33143. The principal who
exercises investment control over this selling stockholder is Rob
Hector. |
|
(31) |
|
Includes 11,000 shares of common stock issuable upon exercise of
warrants with an exercise price of $9.00 per share and expiring in
December 2006. |
24
PLAN OF DISTRIBUTION
Each selling security holder and any of its pledgees, assignees and
successors-in-interest may, from time to time, sell any or all of their common stock on the Nasdaq
Global Market System or any other stock exchange, market or trading facility on which the common
stock is traded or in private transactions. These sales may be at fixed or negotiated prices. A
selling security holder may use any one or more of the following methods when selling their common
stock:
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ordinary brokerage transactions and transactions in which the broker dealer
solicits purchasers; |
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|
block trades in which the broker dealer will attempt to sell the shares as agent
but may position and resell a portion of the block as principal to facilitate the
transaction; |
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|
purchases by a broker dealer as principal and resale by the broker dealer for its account; |
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an exchange distribution in accordance with the rules of the applicable exchange; |
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public or privately negotiated transactions; |
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settlement of short sales entered into after the effective date of the
registration statement of which this prospectus is a part; |
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on the Nasdaq Global Market System (or through facilities of any national
securities exchange or US inter-dealer quotation system of a registered national
securities association on which the common stock is then listed, admitted to
unlisted trading privileges or included for quotation); |
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|
broker-dealers may agree with the selling security holders to sell a specified
number of such shares at a stipulated price per share; |
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|
through underwriters, brokers or dealers (who may act as agents or principals)
or directly to one or more purchasers; |
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|
through the writing or settlement of options or other hedging transactions,
whether through an options exchange or otherwise; |
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a combination of any such methods of sale; or |
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any other method permitted pursuant to applicable law. |
Broker-dealers engaged by the selling security holders may arrange for other brokers-dealers
to participate in sales. Broker-dealers may receive commissions or discounts from the selling
security holders (or, if any broker-dealer acts as agent for the purchaser of shares, from the
purchaser) in amounts to be negotiated, provided that such brokerage commissions are in compliance
with applicable NASD rules relating to commissions and mark-ups unless a supplement to this
Prospectus is required to be delivered to purchasers and the common stock is sold at the public
offering price specified in the supplement.
In connection with the sale of the common stock or interests therein, the selling security
holders may enter into hedging transactions with broker-dealers or other financial institutions,
which may in turn engage in short sales of the common stock in the course of hedging the positions
they assume. The selling security holders may also sell shares of the common stock short and
deliver these securities to close out their short positions, or loan or pledge the common stock to
broker-dealers that in turn may sell these securities. The selling security holders may also enter
into option or other transactions with broker-dealers or other financial institutions or the
creation of one or more derivative securities which require the delivery to such broker-dealer or
other financial institution of shares offered by this prospectus, which shares such broker-dealer
or other financial institution may resell pursuant to this prospectus (as supplemented or amended
to reflect such transaction). The selling security holders may also pledge shares to a
broker-dealer or other financial institution which, upon default, they may in turn resell.
In addition to the foregoing methods, the selling security holders may offer their shares from
time to time in transactions involving principals or brokers not otherwise contemplated above, in a
combination of such methods or described above or any other lawful methods. The selling security
holders may also transfer, donate or assign their shares to lenders, family members and others and
each of such persons will be deemed to be a selling security holder for purposes of this
prospectus. The security holders or their successors in interest may from time to time pledge or
grant a security interest in some or all of the shares of common stock, and if the selling security
holders default in the performance of their secured obligations, the pledgees or secured parties
may offer and sell the shares of common stock from to time under this prospectus; provided however
in the event of a pledge or then default on a secured obligation by the selling security holder, in
order for the shares to be sold under this registration statement,
25
unless permitted by law, we must distribute a prospectus supplement and/or amendment to this
registration statement amending the list of selling security holders to include the pledgee,
secured party or other successors in interest of the security holder under this prospectus.
The selling security holders may also sell their shares pursuant to Rule 144 under the
Securities Act, which permits limited resale of shares purchased in a private placement subject to
the satisfaction of certain conditions, including, among other things, the availability of certain
current public information concerning the issuer, the resale occurring following the required
holding period under Rule 144 and the number of shares being sold during any three-month period not
exceeding certain limitations.
Sales through brokers may be made by any method of trading authorized by any stock exchange or
market on which the shares may be listed or quoted, including block trading in negotiated
transactions. Without limiting the foregoing, such brokers may act as dealers by purchasing any or
all of the shares covered by this prospectus, either as agents for others or as principals for
their own accounts, and reselling such shares pursuant to this prospectus. The selling security
holders may effect such transactions directly, or indirectly through underwriters, broker-dealers
or agents acting on their behalf. In effecting sales, broker-dealers or agents engaged by the
selling security holders may arrange for other broker-dealers to participate. Broker-dealers or
agents may receive commissions, discounts or concessions from the selling security holders, in
amounts to be negotiated immediately prior to the sale (which compensation as to a particular
broker-dealer might be in excess of customary commissions for routine market transactions).
The selling security holders and any broker-dealers or agents that are involved in selling the
shares may be deemed to be underwriters within the meaning of the Securities Act in connection
with such sales. In such event, any profits received by the selling security holders or such
broker-dealers or agents and any profit on the resale of the shares purchased by them may be deemed
to be underwriting commissions or discounts under the Securities Act. We are required to pay
certain fees and expenses incurred by us incident to the registration of the shares. We have
agreed to indemnify the selling security holders against certain losses, claims, damages and
liabilities, including liabilities under the Securities Act.
We agreed to keep this prospectus effective until the earlier of (i) the date on which the
shares may be resold by the selling security holders without registration and without regard to any
volume limitations by reason of Rule 144(e) under the Securities Act or any other rule of similar
effect or (ii) all of the shares have been sold pursuant to the prospectus or Rule 144 under the
Securities Act or any other rule of similar effect.
Under applicable rules and regulations under the Exchange Act, any person engaged in the
distribution of the resale shares may not simultaneously engage in market making activities with
respect to the common stock for the applicable restricted period, as defined in Regulation M, prior
to the commencement of the distribution. In addition, the selling security holders will be subject
to applicable provisions of the Exchange Act and the rules and regulations thereunder, including
Regulation M, which may limit the timing of purchases and sales of shares of the common stock by
the selling security holders or any other person. We will make copies of this prospectus available
to the selling security holders and have informed them of the need to deliver a copy of this
prospectus to each purchaser at or prior to the time of the sale.
26
LEGAL MATTERS
The validity of the issuance of the shares of our common stock described herein has been
passed upon for us by Morgan, Lewis & Bockius LLP.
EXPERTS
The consolidated financial statements of Marshall Edwards, Inc. (a development stage
company) at June 30, 2006 and June 30, 2005, and for each
of the years then ended and for the period from December 1, 2000
(inception) through June 30, 2006, appearing in Marshall Edwards, Inc.s Annual Report (Form 10-K)
for the year ended June 30, 2006, have been audited by BDO, independent registered public
accounting firm, as set forth in their report thereon, included therein, and incorporated herein by
reference. Such consolidated financial statements are incorporated herein by reference in reliance
upon such report given on the authority of such firm as experts in accounting and auditing.
The
consolidated statements of operations, stockholders equity and
cash flows of Marshall Edwards, Inc. (a development stage company)
for the year ended June 30, 2004, and for the period from December 1, 2000 (inception)
through June 30, 2004, appearing in Marshall Edwards, Inc.s Annual Report (Form 10-K) for the year
ended June 30, 2006, have been audited by Ernst & Young, independent registered public accounting
firm, as set forth in their report thereon, included therein, and incorporated herein by reference.
Such consolidated financial statements are incorporated herein by reference in reliance upon such
report given on the authority of such firm as experts in accounting and auditing.
The
consolidated statements of operations, stockholders equity and cash flows of Marshall Edwards, Inc. (a development stage company) for the period from December 1, 2000 (inception) through June 30, 2003, appearing in
Marshall Edwards, Inc.s Annual Report (Form 10-K) for the year
ended June 30, 2006, have been
audited by Ernst & Young LLP, independent registered public accounting firm, as set forth in their
report thereon, included therein, and incorporated herein by reference. Such consolidated financial
statements are incorporated herein by reference in reliance upon such report given on the authority
of such firm as experts in accounting and auditing.
27
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The SEC allows us to incorporate by reference into this prospectus the information we
have filed with the SEC, which means that we can disclose important information to you by referring
you to those documents. Any information that we file subsequently with the SEC will automatically
update this prospectus. We incorporate by reference into this prospectus the information contained
in the documents listed below, which is considered to be a part of this prospectus:
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And our Annual Report on Form 10-K for the fiscal year ended
June 30, 2006 filed on
September 1, 2006; and |
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The description of our common stock contained in Form 8-A filed on November 26,
2003 and the related description of common stock contained in the registration statement on Form
S-1 filed on September 25, 2003, and any further amendment or report filed thereafter for the
purpose of updating such description. |
We also incorporate by reference all documents we subsequently file pursuant to Section
13(a), 13(c), 14 or 15(d) of the Exchange Act after the initial filing date of the registration
statement of which this prospectus is a part and prior to the termination of the offering. The most
recent information that we file with the SEC automatically updates and supersedes older
information. The information contained in any such filing will be deemed to be a part of this
prospectus, commencing on the date on which the document is filed.
You may request a copy of these reports, which we will provide to you at no cost, by
writing or calling us at our mailing address and telephone number: 140 Wicks Road, North Ryde NSW
2113, Australia, telephone: (011) 61 2 8877 6196.
28
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the SEC a registration statement on Form S-3, including exhibits,
under the Securities Act with respect to the shares being offered by and for the account of the
selling stockholders. This prospectus does not contain all of the information set forth in the
registration statement. For further information about us, please refer to the registration
statement and the documents incorporated by reference in this prospectus.
We file annual, quarterly and current reports, proxy statements and other information
with the SEC. Our SEC filings are available to the public over the Internet at the SECs website at
http://www.sec.gov. The SECs website contains reports, proxy statements and other information
regarding issuers, such as Marshall Edwards, that file electronically with the SEC. You may also
read and copy any document we file with the SEC at the SECs Public Reference Room at 100 F Street,
N.E., Washington, D.C. 20549. You may also obtain copies of the documents at prescribed rates by
writing to the SECs Public Reference Section at 100 F Street, N.E., Washington, D.C. 20549. Please
call the SEC at 1-800-SEC-0330 for further information on the operation of its Public Reference
Room.
29
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
The following table lists the costs and expenses payable by the registrant in connection
with the sale of the common stock covered by this prospectus other than any sales commissions or
discounts, which expenses will be paid by the selling stockholders. All amounts shown are estimates
except the SEC registration fee.
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SEC registration fee |
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$ |
2,816 |
|
Legal fees and expenses |
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90,000 |
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Accounting fees and expenses |
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15,000 |
|
Miscellaneous fees and expenses |
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5,000 |
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Total |
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$ |
112,816 |
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Item 15. Indemnification of Directors and Officers
Our Certificate of Incorporation provides that we will indemnify our directors and
officers to the full extent permitted by the Delaware General Corporation Law (DGCL). Section 145
of the DGCL provides that the extent to which a corporation may indemnify its directors and
officers depends on the nature of the action giving rise to the indemnification right. In actions
not on behalf of the corporation, directors and officers may be indemnified for acts taken in good
faith and in a manner reasonably believed to be in or not opposed to the best interests of the
corporation. In actions on behalf of the corporation, directors and officers may be indemnified for
acts taken in good faith and in a manner reasonably believed to be in or not opposed to the best
interests of the corporation, except for acts as to which the director or officer is adjudged
liable to the corporation, unless the relevant court determines that indemnification is appropriate
despite such liability. Section 145 also permits a corporation to (i) reimburse present or former
directors or officers for their defense expenses to the extent they are successful on the merits or
otherwise and (ii) advance defense expenses upon receipt of an undertaking to repay the corporation
if it is determined that payment of such expenses is unwarranted.
To supplement the general indemnification right contained in our Certificate of Incorporation,
our By-Laws provide for the specific indemnification rights permitted by Section 145 (as described
above). Our By-Laws also permit us to purchase Directors & Officers insurance, but no director or
officer has a right to require this.
In addition to the indemnification rights described above, our Certificate of Incorporation
eliminates any monetary liability of directors to us or our stockholders for breaches of fiduciary
duty except for (i) breaches of the duty of loyalty, (ii) acts or omissions in bad faith, (iii)
improper dividends or share redemptions and (iv) transactions from which the director derives an
improper personal benefit.
II-1
Item 16. Exhibits
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Exhibit |
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Number |
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4.1 |
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Specimen Common Stock certificate (1) |
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4.2 |
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Specimen Warrant Certificate (2) |
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4.3 |
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Form of Warrant (3) |
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5.1 |
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Opinion of Morgan, Lewis &
Bockius LLP, counsel to Marshall Edwards, Inc. (4) |
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10.1 |
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Securities Subscription Agreement
dated as of July 11, 2006, by and among Marshall Edwards, Inc. and the purchasers signatory thereto (5) |
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10.2 |
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Registration Rights Agreement dated
as of July 11, 2006, by and among Marshall Edwards, Inc. and the purchasers signatory thereto (6) |
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10.3 |
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Standby Equity Distribution
Agreement dated as of July 11, 2006 by and between Marshall Edwards, Inc. and Cornell Capital Partners, LP (7) |
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10.4 |
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Registration Rights Agreement,
dated as of July 11, 2006 by and between Marshall Edwards, Inc. and Cornell Capital Partners, LP. (8) |
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23.1 |
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Consent of Independent Registered
Public Accounting Firm, BDO (9) |
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23.2 |
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Consent of Independent Registered Public Accounting Firm, Ernst & Young* |
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23.3 |
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Consent of Independent Registered Public Accounting Firm, Ernst & Young LLP* |
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23.4 |
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Consent of Morgan, Lewis & Bockius LLP (contained in Exhibit 5.1) |
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24.1 |
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Power of attorney (included on
signature page) (10) |
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* |
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Filed herewith. |
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(1) |
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Incorporated herein by reference to Exhibit 4.1 to Amendment No. 1 to the registrants
registration statement on Form S-1, filed with the SEC on October 31, 2003. |
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(2) |
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Incorporated by reference to Exhibit 4.2 to
registrants registration statement on Form S-3, filed with
the SEC on August 9, 2006. |
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(3) |
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Incorporated herein by reference to Exhibit 10.4 to the registrants current report on Form
8-K, filed with the SEC on July 12, 2006. |
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(4) |
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Incorporated by reference to Exhibit 5.1 to
registrants registration statement on Form S-3, filed
with the SEC on August 9, 2006. |
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(5) |
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Incorporated herein by reference to Exhibit 10.1 to the registrants current report on Form
8-K/A, filed with the SEC on July 12, 2006. |
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(6) |
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Incorporated herein by reference to Exhibit 10.2 to the registrants current report on Form
8-K, filed with the SEC on July 12, 2006. |
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(7) |
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Incorporated herein by reference to Exhibit 10.1 to the registrants current report on Form
8-K, filed with the SEC on July 12, 2006. |
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(8) |
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Incorporated herein by reference to Exhibit 10.2 to the registrants current report on Form
8-K, filed with the SEC on July 12, 2006. |
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(9) |
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Incorporated by reference to Exhibit 23.3 to
registrants Annual Report on Form 10-K, filed with the SEC
on September 1, 2006. |
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(10) |
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Incorporated by reference to the signature page to
registrants registration statement on Form S-3, filed
with the SEC on August 9, 2006. |
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Item 17. Undertakings
The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a post-effective
amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after the effective date of
the registration statement (or the most recent post-effective amendment thereof) which,
individually or in the aggregate, represent a fundamental change in the information set forth in
the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of
securities offered (if the total dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the estimated maximum offering range may
be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the
aggregate, the changes in volume and price represent no more than a 20 percent change in the
maximum aggregate offering price set forth in the Calculation of Registration Fee table in the
effective registration statement;
(iii) To include any material information with respect to the plan of distribution not
previously
II-2
disclosed in the registration statement or any material change to such information in
the registration statement.
Provided, however, that paragraphs (1)(i), (1)(ii) and (i)(iii) above do not apply if the
registration statement is on Form S-3 or Form F-3 and the information required to be included in a
post-effective amendment by those paragraphs is contained in reports filed with or furnished to the
Commission by the registrant pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934
that are incorporated by reference in the registration statement, or is contained in a form of
prospectus filed pursuant to Rule 424(b)) that is part of the registration statement.
(2) That, for the purpose of determining any liability under the Securities Act of 1933, each
such post-effective amendment shall deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities
being registered which remain unsold at the termination of the offering.
(4) If the registrant is subject to Rule 430C, each prospectus filed pursuant to Rule 424(b) as
part of a registration statement relating to an offering, other than registration statements
relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to
be part of and included in the registration statement as of the date it is first used after
effectiveness. Provided, however, that no statement made in a registration statement or prospectus
that is part of the registration statement or made in a document incorporated or deemed
incorporated by reference into the registration statement or prospectus that is part of the
registration statement will, as to a purchaser with a time of contract of sale prior to such first
use, supersede or modify any statement that was made in the registration statement or prospectus
that was part of the registration statement or made in any such document immediately prior to such
date of first use.
The undersigned registrant hereby undertakes that, for purposes of determining any liability
under the Securities Act of 1933, each filing of the registrants annual report pursuant to Section
13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing
of an employee benefit plans annual report pursuant to Section 15(d) of the Securities Exchange
Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be
a new registration statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering thereof.
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be
permitted to directors, officers and controlling persons of the registrant pursuant to the
foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the
Securities and Exchange Commission such indemnification is against public policy as expressed in
the Act and is, therefore, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the registrant of expenses incurred or paid by a
director, officer or controlling person of the registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person in connection with
the securities being registered, the registrant will, unless in the opinion of its counsel the
matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the
question whether such indemnification by it is against public policy as expressed in the Securities
Act of 1933 and will be governed by the final adjudication of such issue.
II-3
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that
it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3
and has duly caused this pre-effective Amendment No. 1 to registration statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in the City of Sydney, Australia, on this
1st day of September, 2006.
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MARSHALL EDWARDS, INC. |
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By: |
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/s/ David R. Seaton |
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David R. Seaton
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Chief Financial Officer and
Secretary |
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II-4
EXHIBIT INDEX
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Exhibit |
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Number |
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4.1
|
|
Specimen Common Stock certificate (1) |
|
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|
4.2
|
|
Specimen Warrant Certificate (2) |
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|
|
4.3
|
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Form of Warrant (3) |
|
|
|
5.1
|
|
Opinion of Morgan, Lewis &
Bockius LLP, counsel to Marshall Edwards, Inc. (4) |
|
|
|
10.1
|
|
Securities Subscription Agreement dated as of July 11, 2006, by and among
Marshall Edwards, Inc. and the purchasers signatory thereto (5) |
|
|
|
10.2
|
|
Registration Rights Agreement dated as of July 11, 2006, by and among
Marshall Edwards, Inc. and the purchasers signatory
thereto (6) |
|
|
|
10.3
|
|
Standby Equity Distribution Agreement dated as of July 11, 2006 by and between
Marshall Edwards, Inc. and Cornell Capital
Partners, LP (7) |
|
|
|
10.4
|
|
Registration Rights Agreement, dated as of July 11, 2006 by and between
Marshall Edwards, Inc. and Cornell Capital Partners,
LP. (8) |
|
|
|
23.1
|
|
Consent of Independent Registered
Public Accounting Firm, BDO (9) |
|
|
|
23.2
|
|
Consent of Independent Registered Public Accounting Firm, Ernst & Young* |
|
|
|
23.3
|
|
Consent of Independent Registered Public Accounting Firm, Ernst & Young LLP* |
|
|
|
23.4
|
|
Consent of Morgan, Lewis & Bockius LLP (contained in Exhibit 5.1) |
|
|
|
24.1
|
|
Power of attorney (included on
signature page) (10) |
|
|
|
|
|
* |
|
Filed herewith. |
|
(1) |
|
Incorporated herein by reference to Exhibit 4.1 to Amendment No. 1 to the registrants
registration statement on Form S-1, filed with the SEC on October 31, 2003. |
|
(2) |
|
Incorporated by reference to Exhibit 4.2 to
registrants registration statement on Form S-3, filed with
the SEC on August 9, 2006. |
|
(3) |
|
Incorporated herein by reference to Exhibit 10.4 to the registrants current report on Form
8-K, filed with the SEC on July 12, 2006. |
|
(4) |
|
Incorporated by reference to Exhibit 5.1 to
registrants registration statement on Form S-3, filed
with the SEC on August 9, 2006. |
|
(5) |
|
Incorporated herein by reference to Exhibit 10.1 to the registrants current report on Form
8-K/A, filed with the SEC on July 12, 2006. |
|
(6) |
|
Incorporated herein by reference to Exhibit 10.2 to the registrants current report on Form
8-K, filed with the SEC on July 12, 2006. |
|
(7) |
|
Incorporated herein by reference to Exhibit 10.1 to the registrants current report on Form
8-K, filed with the SEC on July 12, 2006. |
|
(8) |
|
Incorporated herein by reference to Exhibit 10.2 to the registrants current report on Form
8-K, filed with the SEC on July 12, 2006. |
|
(9) |
|
Incorporated by reference to Exhibit 23.3 to
registrants Annual Report on Form 10-K, filed with the SEC
on September 1, 2006. |
|
(10) |
|
Incorporated by reference to the signature page to
registrants registration statement on Form S-3, filed
with the SEC on August 9, 2006. |
|
EX-23.2
Exhibit 23.2
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent
to the reference to our firm under the caption Experts in the Registration Statement (Pre-effective Amendment
No. 1 to the Form S-3 No. 333-136440) and related Prospectus of Marshall Edwards, Inc. for the registration
of 9,268,195 shares of its common stock and to the incorporation by reference therein of our report
dated 13 August 2004, with respect to the consolidated financial statements of Marshall Edwards, Inc., included
in its Annual Report (Form 10-K) for the year ended June 30, 2006, filed with the Securities and
Exchange Commission.
/s/ Ernst & Young
Sydney, Australia
4 September, 2006
EX-23.3
Exhibit 23.3
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the reference to our firm under the caption Experts in the Registration Statement
(Pre-effective Amendment No. 1 to the Form S-3 No. 333-136440) and related Prospectus of Marshall
Edwards, Inc. for the registration of 9,268,195 shares of its common stock and to the incorporation by reference
therein of our report dated July 31, 2003, with respect to the consolidated financial statements of Marshall
Edwards, Inc., included in its Annual Report (Form 10-K) for the year ended June 30, 2006, filed with the
Securities and Exchange Commission.
/s/ Ernst
& Young LLP
Stamford, Connecticut
September 4, 2006