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As filed with the Securities and Exchange Commission on October 2, 2007
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Registration Statement No. 333- |
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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
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51-0407811 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification Number) |
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140 Wicks Road |
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North Ryde NSW 2113 Australia |
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(011) 61 2 8877 6196 |
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(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
President & Chief Executive Officer
Marshall Edwards, Inc.
140 Wicks Road
North Ryde NSW 2113 Australia
(011) 61 2 8877 6196
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Steven A. Navarro, Esq.
Morgan, Lewis & Bockius LLP
101 Park Avenue
New York, New York 10178
(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
CALCULATION OF REGISTRATION FEE
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Proposed Maximum |
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Proposed Maximum |
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Amount to be |
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Offering Price |
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Aggregate |
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Amount of |
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Title of Securities to be Registered |
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Registered(1) |
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Per Share(2) |
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Offering Price(2) |
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Registration Fee |
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Common Stock, $0.00000002 par value per share |
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7,897,963 |
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$ |
3.04 |
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$ |
24,009,807.52 |
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$ |
737.10 |
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(1) |
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Includes 5,464,001 shares of common stock issued and sold and up to 2,433,962 shares
of common stock issuable upon exercise of warrants outstanding on the date hereof, as may be
amended from time to time, and shares of common stock issuable 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. |
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(2) |
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Estimated solely for the purpose of calculating the registration fee pursuant to
Rule 457(c) of the Securities Act of 1933, based on the average of the high and low sales
prices of the common stock, as reported on the Nasdaq Global Market on October 1, 2007. |
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 OCTOBER 2, 2007
MARSHALL EDWARDS, INC.
7,897,963 Shares of Common Stock
Common Stock
This prospectus covers 7,897,963 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 October 1, 2007 was $3.02
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 3 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 , 2007.
TABLE OF CONTENTS
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Page |
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SUMMARY |
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RISK FACTORS |
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS |
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USE OF PROCEEDS |
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SELLING STOCKHOLDERS |
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PLAN OF DISTRIBUTION |
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LEGAL MATTERS |
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EXPERTS |
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INCORPORATION OF CERTAIN INFORMATION BY REFERENCE |
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WHERE YOU CAN FIND MORE INFORMATION |
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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, 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 71.9% of our outstanding common stock.
We commenced operation in May 2002 and our business purpose is the development and
commercialization of drugs for the treatment of cancer. We are presently engaged in the clinical
development and commercialization of a drug candidate called phenoxodiol which we have licensed
from a subsidiary of Novogen. We believe that phenoxodiol may have broad application against a wide
range of cancers. Phenoxodiol appears to target a number of key components involved in cancer cell
survival and proliferation based on the emerging field of signal transduction regulation, with
little or no effect on normal cells detected in pre-clinical testing. We have also licensed two
other anti-cancer compounds, NV-196 and NV-143, from a subsidiary of Novogen.
Our strategy is to undertake further clinical development and testing of phenoxodiol, focusing
on those therapeutic indications that will expedite drug marketing approval by regulatory bodies,
leading to phenoxodiols commercialization and wide scale distribution. We also plan to develop
NV-196 and NV-143 for therapeutic indications not currently targeted by phenoxodiol.
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 the FDA granted
phenoxodiol fast tract status for treatment of patients with recurrent late stage ovarian cancer
that is resistant or refractory to platins and taxanes in 2004, and for treatment of patients with
hormone refractory prostate cancer, which is prostate cancer that grows and is not inhibited by
hormone therapy, in 2005.
The clinical development phase has included the following studies: (1) a Phase Ib/IIa clinical
trial with intravenous and oral dosage forms of phenoxodiol in combination with chemotherapy drugs
in patients with refractory ovarian cancer in the United States and Australia; (2) a Phase I/II
study of the oral dosage form in Australia in patients with hormone-refractory prostate cancer; (3)
a Phase Ib/IIa study of the oral dosage form in the United States in patients with cervical cancer;
(4) a Phase I study of the oral dosage form in combination with chemotherapy drugs in patients with
advanced malignancies in Australia; and (5) an ongoing world-wide Phase III pivotal trial of the
oral dosage form in combination with carboplatin in patients with platinum-resistant ovarian cancer
that does not respond to platinum based anti-cancer agents such as cisplatin.
For the Phase III pivotal trial, we completed a Special Protocol Assessment (SPA) with FDA in
May 2006. 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 candidate, phenoxodiol will be eligible
for accelerated approval and priority review 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.
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 in Australia 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. Moderate activity was observed against colorectal cancer cells.
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.
The mechanisms by which NV-143 elicits its anti-cancer/chemo-sensitizing effect remain unresolved.
NV-143 is initially being developed to target the treatment of melanoma.
Recent Developments
Private Placement
On August 1, 2007, we entered into a securities subscription agreement with certain accredited
investors (referred to herein, along with Blue Trading, LLC, as the selling stockholders) providing
for the private placement of 5,464,001 shares of our common stock at a purchase price of $3.00 per
share. The investors in the transaction also received a warrant to purchase an additional 4 shares
of common stock for every block of 10 shares of common stock purchased. The warrants have an
exercise price of $3.60 per share. The warrants may be exercised beginning February 6, 2008 and
will expire five years from the date of issuance, on August 6, 2012. We also issued 62,091 warrants
to Blue Trading, LLC, which acted as the placement agent in the private placement, as part of the
placement fee. The warrants issued to Blue Trading, LLC have an exercise price of $3.00 per share
and each warrant is convertible for 4 shares of common stock. These warrants may be exercised
immediately and will expire five years from the date of issuance, on August 6, 2012. We closed the
private placement on August 6, 2007. On August 6, 2007, we also terminated a standby equity
distribution agreement with Cornell Capital Partners, LP, pursuant to which we were given the
option of issuing and selling to Cornell Capital Partner, LP shares of our common stock for a total
purchase price of up to $15 million.
Securities Offered
We are registering for resale by the selling stockholders 5,464,001 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 2,433,962 shares of
our common stock issuable upon exercise of warrants issued in the same transactions and 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 will need additional funds to complete the OVATURE Phase III clinical trial for phenoxodiol and
to progress the clinical trial program for NV-196 and NV-143. The actual amount of funds we will
need will be determined by a number of factors, some of which are beyond our control.
We will need additional funds to complete the OVATURE Phase III clinical trial for phenoxodiol
and to progress the clinical trial for phenoxodiol and to progress the clinical trial program for
NV-196 and NV-143. The actual amount of funds that we will need to complete these projects will be
determined by a number of factors, some of which are beyond our control. These factors may include
the following:
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the number of sites included in the trials; |
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the length of time required to enroll suitable patients; |
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the number of patients that participate in the trials and the rate that they are
recruited; |
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the number of treatment cycles patients complete while they are enrolled in the trials;
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the efficacy and safety profile of the product. |
If we are unable to obtain additional funds on favourable terms we may be required to cease or
reduce our operations. Also, if we raise more funds by selling additional shares of our common
stock or securities convertible into or exercisable for shares of our common stock, the ownership
interests of our common stockholders will be diluted.
We may not complete our OVATURE Phase III trial on schedule, or at all, or it may be conducted
improperly, which will delay or preclude FDA marketing approval and increase costs.
The completion of our OVATURE clinical trial may be delayed or terminated for many reasons,
including, but not limited to, if:
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we are unable to identify and contract clinical trial sites and clinical investigators
at the rate we expect or those sites are delayed from commencing patient recruitment due
to regulatory hospital ethics committee approvals or those investigators do not perform to
our anticipated patient recruitment schedule or comply with the clinical trial protocol; |
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patients are not available to enrol at the rate we currently expect, or that trial
sites are unable to recruit their target patient numbers due to the strict inclusion
criteria of the OVATURE protocol which may reduce the patient pool available to
participate in the trial; |
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subjects experience an unacceptable rate or severity of adverse side effects; |
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third party clinical investigators do not conduct the trial in compliance with Good
Clinical Practice and regulatory requirements, or other third parties do not perform data
collection and analysis in a timely or accurate manner; |
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one or more IRB suspends or terminates the trial at an investigational site, precludes
enrolment of additional subjects, or withdraws its approval of the trial; or |
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one or more of our clinical investigators withdraws from our trials or deviates from
our approved protocol. |
Our costs will increase if we have material delays in our OVATURE pivotal trial, or if we are
required to modify, suspend, terminate or repeat it.
If the data from our OVATURE Phase III clinical trial do not demonstrate the safety and
effectiveness of phenoxodiol to the FDAs satisfaction, we will not receive FDA approval to market
phenoxodiol in the United States.
In 2004, the FDA granted phenoxodiol fast track status for patients with recurrent late stage
ovarian cancer that is resistant or refractory to platins and taxanes. More recently we completed
an SPA where the FDA reviewed and agreed with the design of a Phase III study of phenoxodiol in
combination with carboplatin in women with platinum-resistant ovarian cancer (ovarian cancer that
does not respond to platinum based anti-cancer agents such as cisplatin). If the FDA concludes,
using agreed clinical endpoints, that the data from our pivotal clinical trial have failed to
demonstrate the safety and effectiveness of phenoxodiol to the satisfaction of the FDA, we will not
receive FDA approval to market phenoxodiol in the United States. We cannot assure you that the
results of our Phase III trial will be successful.
The third-party manufacturers that we rely upon for the production of phenoxodiol for our clinical
trials, and for future commercial quantities, may not be in compliance with FDA regulatory
requirements.
The conduct of our clinical trials and approval of our marketing application for phenoxodiol
may be delayed or adversely affected if the third-party manufacturers that we rely upon for the
production of phenoxodiol fail to comply with FDAs regulatory requirements for cGMPs. FDA
requires drug manufacturers to establish and maintain quality control procedures for manufacturing,
processing, and holding drugs and investigational products, and products must be manufactured in
accordance with defined specifications. The failure of contract manufacturers to supply
investigational product in compliance with the defined specifications for phenoxodiol may delay the
completion of our clinical trials. As part of the pre-market approval process, the manufacturer
will be inspected by FDA to ensure compliance with cGMPs. The failure of contract manufacturers to
comply with applicable regulations may result in a delay or prevent approval of our marketing
application.
If we do not receive marketing approval, our commercial prospects for phenoxodiol will be impaired.
Clinical trials have a high risk of failure. A number of companies in the pharmaceutical
industry, including biotechnology companies, have suffered significant setbacks in advanced
clinical trials, even after achieving promising results in earlier trials. If our clinical trials
are unsuccessful, our prospects for commercializing phenoxodiol will be impaired and we may be
required to cease or reduce our operations. This will have a significant impact on our share price.
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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 have a limited operating history, and we are likely to incur operating losses for the
foreseeable future.
You should consider our prospects in light of the risks and difficulties frequently
encountered by early stage and developmental companies. Although we were incorporated in December
2000, we have only been in operation since May 2002. We have incurred net losses of $39,321,000
since our inception, including net losses of $13,820,000, $7,386,000 and $6,421,000 for the years
ended June 30, 2007, 2006 and 2005, respectively. We anticipate that we will incur operating losses
and negative operating cash flow for the foreseeable future. We have not yet commercialized any
drug candidates and cannot be sure that we will ever be able to do so, or that we may ever become
profitable. We have expanded our clinical trials significantly with the commencement of the OVATURE
trial, which will result in increasing losses and we may continue to incur substantial losses in
future even if we begin to generate revenues from the distribution and sale of phenoxodiol.
We may not be able to establish the strategic partnerships necessary to develop, market and
distribute phenoxodiol.
A key part of our business plan is to establish relationships with strategic partners. We must
successfully contract with third parties to package, market and distribute phenoxodiol. We have not
yet established any strategic partnerships. Potential partners may not wish to enter into
agreements with us due to Novogens current equity position as our majority stockholder or our
contractual relationships with Novogen. Similarly, potential partners may be discouraged by our
limited operating history. Additionally, our relative attractiveness to potential partners and
consequently, our ability to negotiate acceptable terms in any partnership agreement will be
affected by the results
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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 have not yet submitted an IND for NV-196 or NV-143 product candidates with the FDA and until an
IND becomes effective, we will not be able to perform human clinical trials in the United States.
Although we have conducted two Phase I clinical trials of NV-196 in Australia, we have not yet
submitted an IND to the FDA. NV-143 has not yet commenced clinical trials in humans. Until an IND
becomes effective, we will not be able to perform human clinical trials of our NV-196 or NV-143
product candidates in the United States. Approval to begin clinical testing in the United States
requires submission of: (i) adequate information on the safety and manufacturing of NV-196 or
NV-143 to assure the proper identification quality, purity and strength of the investigational
product, (ii) summary of pharmacological and toxicological effects, pharmacokinetics (how the drug
is absorbed and metabolised) and biological disposition in animals, (iii) the proposed protocol for
any planned clinical study, and (iv) a brief description of the overall plan for investigating the
product. Although we intend to prepare an IND to be submitted to the FDA, we do not know whether or
when the IND will become effective.
Our commercial opportunity will be reduced or eliminated if competitors develop and market products
that are more effective, have fewer side effects or are less expensive than phenoxodiol.
The development of phenoxodiol and other drug candidates is highly competitive. A number of
other companies have products or drug candidates in various stages of pre-clinical or clinical
development that are intended for the same therapeutic indications for which phenoxodiol is being
developed. Some of these potential competing drugs are further advanced in development than
phenoxodiol and may be commercialized sooner. Even if we are successful in developing effective
drugs, phenoxodiol may not compete successfully with products produced by our competitors.
Our competitors include pharmaceutical companies and biotechnology companies, as well as
universities and public and private research institutions. In addition, companies active in
different but related fields represent substantial competition for us. Many of our competitors
developing oncology drugs have significantly greater capital resources, larger research and
development staffs and facilities and greater experience in drug development, regulation,
manufacturing and marketing than us. These organizations also compete with Novogen, our services
provider, to recruit qualified personnel, and with us to attract partners for joint ventures and to
license technologies that are competitive with ours. As a result, our competitors may be able to
more easily develop technologies and products that would render our technologies or our drug
candidates obsolete or non-competitive.
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We have no direct control over the costs of manufacturing phenoxodiol, NV-196 or NV-143 and
increases in these costs would increase the costs of conducting clinical trials and could adversely
affect future profitability if these costs increase significantly.
We do not intend to manufacture phenoxodiol or NV-196 or NV-143 ourselves and we will be
relying on third parties for our supplies of phenoxodiol both for clinical trials and for
commercial quantities in the future. Novogen, has taken the strategic decision not to manufacture on a large scale APIs for cancer
drugs, including phenoxodiol, as these can be more economically supplied by third parties with
particular expertise in this area. The contract facilities that have been identified are registered
with the FDA, have a track record of large scale APIs manufacture and have already invested in
capital and equipment. We have completed the novation to Marshall Edwards Pty Limited (MEPL) of
contracts that Novogen had entered into with third parties to validate the developed scalable
manufacturing method to ensure that sufficient quantities of phenoxodiol can be manufactured in
compliance with the FDAs current Good Manufacturing Practices (cGMP) and to complete the
analytical and stability work necessary for a New Drug Application (NDA) submission for marketing
approval. An NDA will be submitted if the planned Phase III study is successful, and approval of
the NDA is required to market phenoxodiol. We will need to arrange similar contracts in the future
to secure the supply of NV-196 and NV-143. We have no direct control over the costs of
manufacturing our product candidates. If the costs of manufacturing increase or if the cost of the
materials used increases, these costs will be passed on to us making the cost of conducting
clinical trials more expensive. Increases in manufacturing costs could adversely affect our future
profitability if we are unable to pass all of the increased costs along to our customers.
We may not be able to secure and maintain suitable research institutions to conduct our clinical
trials.
We rely on suitable research institutions, of which there are many, to conduct our clinical
trials. Our reliance upon research institutions, including hospitals and cancer clinics, provides
us with less control over the timing and cost of clinical trials and the ability to recruit
patients than if we had conducted the trials on our own. Further, there is a greater likelihood
that disputes may arise with these research institutions over the ownership of intellectual
property discovered during the clinical trials. If we are unable to reach agreement with suitable
research institutions on acceptable terms, or if any resulting agreement is terminated and we are
unable to quickly replace the applicable research institution with another qualified institution on
acceptable terms, the research could be delayed and we may be unable to complete development, or
commercialize phenoxodiol, NV-196 or NV-143, which will adversely affect our ability to generate
operating revenues.
We face a risk of product liability claims and may not be able to obtain adequate insurance.
Our business exposes us to the risk of product liability claims. This risk is inherent in the
manufacturing, testing and marketing of human therapeutic products. We have product liability
insurance coverage of up to approximately $17.4 million. Although we believe that this amount of
insurance coverage is appropriate for our business at this time, it is subject to deductibles and
coverage limitations, and the market for such insurance is becoming more restrictive. We may not be
able to obtain or maintain adequate protection against potential liabilities. If we are unable to
sufficiently insure against potential product liability claims, we will be exposed to significant
liabilities, which may materially and adversely affect our business development and
commercialization efforts.
Our rights to develop and exploit phenoxodiol and the anti-cancer compounds NV-196 and NV-143 are
subject to the terms and conditions of agreements we have entered into with Novogen, and under
these agreements our rights may be terminated under certain circumstances, some of which may be
beyond our control.
We have licensed the intellectual property in the phenoxodiol technology and the anti-cancer
compounds NV-196 and NV-143 from Novogen. Under the terms of the license agreement for phenoxodiol,
all forms of administering phenoxodiol for the treatment of cancer are licensed to us, excluding
topical applications. Under the terms of the license agreement for NV-196 and NV-143, all forms of
administering drugs containing the anti-cancer compounds NV-196 and NV-143 are licensed to us,
excluding topical applications. If we fail to meet our obligations
7
under our license agreements, the manufacturing license and supply agreement or the services
agreement with Novogen, any or all of these agreements may be terminated by Novogen and we could
lose our rights to develop phenoxodiol or anti-cancer drugs containing NV-196 and NV-143. To date,
we have no reason to believe that we will be unable to satisfy our obligations under these
agreements. In addition, each of these agreements may be terminated immediately by Novogen in the
event that we undergo a change of control without the consent of Novogen. A change of control
means a change in control of more than half the voting rights attaching to the shares of our
subsidiary, a change in control of more than half of the issued shares of our subsidiary (not
counting any share which carries no right to participate beyond a specified amount in the
distribution of either profit or capital) or a change in control of the composition of the board of
directors of our subsidiary. Each of these agreements may also be terminated if we cease for any
reason to be able to lawfully carry out all the transactions required by each respective agreement.
Our license rights are fundamental to our business and therefore a loss of these rights will likely
cause us to cease operations.
The rights granted to us under the license agreements, the manufacturing license and supply
agreement and the license option deed with Novogen are fundamental to our business. The license
agreement for phenoxodiol grants us the right to make, have made, market, distribute, sell, hire or
otherwise dispose of phenoxodiol products in the field of prevention, treatment or cure of cancer
in humans by pharmaceuticals delivered in all forms except topical applications. The license
agreement for NV-196 and NV-143 grants us the right to make, have made, market, distribute, sell,
hire or otherwise dispose of anti-cancer drugs containing the compounds NV-196 and NV-143 in the
field of prevention, treatment or cure of cancer in humans by pharmaceuticals delivered in all
forms except topical applications. Our business purpose is to develop and commercialize cancer
drugs including phenoxodiol and drugs containing the compounds NV-196 and NV-143, which we would be
unable to pursue without the rights granted to us under the license agreements. The license option
deed grants us an exclusive first right to accept and exclusive last right to match any proposed
dealing by Novogen with its intellectual property rights with a third party relating to certain
compounds (other than phenoxodiol) developed by Novogen and its affiliates which have applications
in the field of prevention, treatment or cure of cancer in humans. The license option deed is
important to our business because it allows us to maintain control over the sale by Novogen of
complementary as well as potentially competitive intellectual property rights to third party
competitors. Any loss of the rights under any of these agreements will likely cause us to cease
operations.
The success of our product candidates is largely dependent on Novogens ability to obtain and
maintain patent protection and preserve trade secrets, which cannot be guaranteed.
Patent protection and trade secret protection are important to our business and our future
will depend, in part on our ability and the ability of Novogen to maintain trade secret protection,
obtain patents and operate without infringing the proprietary rights of others both in the United
States and abroad. Litigation or other legal proceedings may be necessary to defend against claims
of infringement, to enforce our patents, or to protect our trade secrets or the trade secrets of
Novogen. Such litigation could result in substantial costs and diversion of our managements
attention. Novogen has not been involved in any opposition re-examination trade secret dispute,
infringement litigation or any other litigation or legal proceedings pertaining to the licensed
patent rights.
8
The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and
involve complex legal and factual questions. Novogen has applied for patents in a number of
countries with respect to the use of phenoxodiol for the treatment, prevention or cure of cancer.
We have licensed both issued patents and
pending patent applications from Novogen. Novogen has issued patents in the United States,
Australia and Singapore covering the use of phenoxodiol to prevent or treat skin cancer from
ultraviolet damage. Novogen also has patents issued in Australia, Hong Kong, New Zealand and the
United Kingdom related to phenoxodiol for the treatment of a variety of cancers and has recently
received a patent grant in the United States that is also related to phenoxodiol for the treatment
of a variety of cancers.
Novogens applications may not proceed to grant or may be amended to reduce the scope of
protection of any patent granted. The applications and patents may also be opposed or challenged by
third parties. Our commercial success will depend, in part, on the ability of Novogen and our
ability to obtain and maintain effective patent protection for the technologies underlying
phenoxodiol and other compounds, and to successfully defend patent rights in those technologies
against third-party challenges. As patent applications in the United States are maintained in
secrecy until published or issued and as publication of discoveries in the scientific or patent
literature often lag behind the actual discoveries, we cannot be certain that Novogen was the first
to make the inventions covered by its pending patent applications or issued patents or that it was
the first to file patent applications for such inventions. Additionally, the breadth of claims
allowed in biotechnology and pharmaceutical patents or their enforceability cannot be predicted. We
cannot be sure that any additional patents will issue from any of Novogens patent applications or,
should any patents issue, that we will be provided with adequate protection against potentially
competitive products. Furthermore, we cannot be sure that should patents issue, they will be of
commercial value to us, or that private parties, including competitors, will not successfully
challenge our patents or circumvent our patent position in the United States or abroad.
Claims by other companies that we infringe their proprietary technology may result in liability for
damages or stop our development and commercialization efforts.
The pharmaceutical industry is highly competitive and patents have been applied for by, and
issued to, other parties relating to products competitive with phenoxodiol. Therefore, phenoxodiol
and any other drug candidates may give rise to claims that they infringe the patents or proprietary
rights of other parties existing now and in the future. Furthermore, to the extent that we or
Novogen or our respective consultants or research collaborators use intellectual property owned by
others in work performed for us or Novogen, disputes may also arise as to the rights in such
intellectual property or in resulting know-how and inventions. An adverse claim could subject us to
significant liabilities to such other parties and/or require disputed rights to be licensed from
such other parties.
We have currently contracted formulation development and manufacturing process development
work for phenoxodiol formulation. This work is being conducted to ensure that there is a robust
production process which meets the expected commercial quantities of phenoxodiol and that dose
formulations are manufactured on a cost effective basis.
This process has identified a number of excipients, or additives to improve drug delivery,
that may be used in the formulations of phenoxodiol. Excipients, among other things, perform the
function of a carrier of the active drug ingredient in the intravenous formulation. Some of these
identified excipients or carriers may be included in third party patents in some countries. We
intend to seek a license if we decide to use a patented excipient in the marketed intravenous
product or we may choose one of those excipients that do not have a license requirement.
9
We cannot be sure that any license required under any such patents or proprietary rights would
be made available on terms acceptable to us, if at all. If we do not obtain such licenses, we may
encounter delays in product
market introductions, or may find that the development, manufacture or sale of products requiring
such licenses may be precluded. We have not conducted any searches or made any independent
investigations of the existence of any patents or proprietary rights of other parties.
We may be subject to substantial costs stemming from our defense against third-party intellectual
property infringement claims.
Third parties may assert that we or Novogen are using their proprietary information without
authorization. Third parties may also have or obtain patents and may claim that technologies
licensed to or used by us infringe their patents. If we are required to defend patent infringement
actions brought by third parties, or if we sue to protect our own patent rights, we may be required
to pay substantial litigation costs and managerial attention may be diverted from business
operations even if the outcome is not adverse to us. In addition, any legal action that seeks
damages or an injunction to stop us from carrying on our commercial activities relating to the
affected technologies could subject us to monetary liability and require us or Novogen or any third
party licensors to obtain a license to continue to use the affected technologies. We cannot predict
whether we or Novogen would prevail in any of these types of actions or that any required license
would be made available on commercially acceptable terms or at all.
In the event that Novogen does not comply with its obligations under a grant from the Australian
Government under which phenoxodiol was, in part, developed, our rights to use the intellectual
property relating to phenoxodiol and developed by Novogen may revert back to the Australian
Government.
Novogen developed phenoxodiol in part using funds from the Australian Government under what is
known as the START Program. Under the START Program, Novogen must meet certain project development
and commercialization obligations. Novogen has met the project development obligations and has
received final payment thereon. Novogen believes it is currently in compliance with its
commercialization schedule. Although Novogen believes that it has complied with its obligations
under the START Program, if the Australian Government disagrees or if Novogen undergoes a change of
control without the prior consent of the Australian Government, the Australian Government has a
right to demand that intellectual property created during the course of the project funded by the
grant be vested back in the Australian Government or demand repayment of the funds paid to Novogen
under the program. The Australian Government may then license the intellectual property rights
related to phenoxodiol to other parties and may demand other intellectual property rights from
Novogen. Any such reclamation by the Australian Government could preclude our use of Novogens
intellectual property in the development and commercialization of phenoxodiol and we may have to
compete with other companies to whom the Australian Government may license the intellectual
property.
The enforcement of civil liabilities against our officers and directors may be difficult.
Most of our officers and directors are residents of jurisdictions outside the United States.
As a result it may be difficult for you to effect service of process within the United States upon
all our officers and directors or to enforce judgments obtained against all our officers and
directors or us in United States courts.
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Our results are affected by fluctuations in currency exchange rates.
Much of our expenditures and potential revenue will be spent or derived outside of the United
States. As a result, fluctuations between the United States dollar and the currencies of the
countries in which we operate may
increase our costs or reduce our potential revenue. At present, we do not engage in hedging
transactions to protect against uncertainty in future exchange rates between particular foreign
currencies and the U.S. dollar.
We are authorized to issue a class of blank check preferred stock, which could adversely affect the
holders of our common stock.
Our restated certificate of incorporation allows us to issue a class of blank check preferred
stock with rights potentially senior to those of our common stock without any further vote or
action by the holders of our common stock. The issuance of preferred stock could decrease the
amount of earnings and assets available for distribution to the holders of our common stock or
could adversely affect the rights and powers including voting rights, of such holders. In certain
circumstances such issuance could have the effect of decreasing the market price of our shares, or
making a change in control of us more difficult.
Risks Related to Our Relationship with Novogen
As our majority stockholder, Novogen has the ability to determine the outcome of all matters
submitted to our stockholders for approval and Novogens interests may conflict with ours or our
other stockholders interests.
Novogen beneficially owns approximately 71.9% of our outstanding shares of common stock. As a
result, Novogen will have the ability to effectively determine the outcome of all matters submitted
to our stockholders for approval, including the election and removal of directors and any merger,
consolidation or sale of all or substantially all of our assets.
Novogen will have the ability to effectively control our management and affairs. Novogens
interests may not always be the same as that of our other stockholders. In addition this
concentration of ownership may harm the market price of our shares by:
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impeding a merger, consolidation, takeover or other business combination involving us; |
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discouraging a potential acquirer from making a tender, offer or otherwise attempting to
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selling us to a third party. |
Three of our directors and our secretary and chief financial officer are officers and/or directors
of Novogen and other Novogen subsidiaries, which may create a conflict of interest as well as
prevent them from devoting their full attention to us.
Three of our board members currently serve as board members of Novogen. Simultaneous service
as a Novogen director or officer could create, or appear to create, a conflict of interest when
such directors are presented with decisions that could have different implications for us and
Novogen.
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Mr. Philip Johnston is the chairman of Novogen Limited, Mr. Christopher Naughton is the
managing director of Novogen Limited and Professor Paul John Nestel is a director of Novogen
Limited. Mr. David Seaton is
chief financial officer of Novogen. The responsibilities of Messrs. Johnston, Naughton and Seaton
and Professor Nestel to Novogen could prevent them from devoting their full attention to us, which
could be harmful to the development of our business.
We depend on a number of key personnel whose services are provided by Novogen under our services
agreement. If we are not able to procure these services in the future, the strategic direction of
the clinical development program would be disrupted, causing a delay in our commercialization
program.
We currently rely on Professor Alan Husband, Novogen Research Director, and Mr. Christopher
Naughton, our President and Chief Executive Officer, to provide the strategic direction for the
clinical development of phenoxodiol. If we are unable to secure the ongoing services of these key
personnel, the commercialization program for phenoxodiol will be disrupted and will cause delays in
obtaining marketing approval. Novogen has entered into employment agreements with Professor Husband
and Mr. Naughton.
Novogen can compete with us.
We have no contract, arrangement or understanding with Novogen to preclude it from developing
a product which may be competitive with phenoxodiol, NV-196 or NV-143 or to use these compounds for
any uses other than anti-cancer applications. Novogen has reserved the intellectual property rights
and know-how rights relating to topical applications of these compounds even in the field of
cancer. There can be no assurance that Novogen or its subsidiaries will not pursue alternative
technologies or product candidates as a means of developing treatments for the conditions targeted
by phenoxodiol or any other product candidate which we seek to exploit.
We are dependent on Novogen for our personnel.
We have no employees. We rely on Novogen to provide or procure the provision of staff and
other financial and administrative services under our services agreement with Novogen. We believe
Novogen has fully complied with the terms of our services agreement. To successfully develop our
drug candidates, we will require ongoing access to the personnel who have, to date, been
responsible for the development of our drug candidates. The services agreement does not specify a
minimum amount of time that Novogen employees must devote to our operations. If we are unable to
secure or if we lose the services of these personnel, the ability to develop our drug candidates
could be materially impaired. Moreover, if our business experiences substantial and rapid growth,
we may not be able to secure the services and resources we require from Novogen or from other
persons to support that growth.
Risks Related to Our Common Stock
The trading price of the shares of our common stock could be highly volatile and could decline in
value and we may incur significant costs from class action litigation.
The trading price of our common stock could be highly volatile in response to various factors,
many of which are beyond our control, including:
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developments concerning phenoxodiol and our other drug candidates NV-196 and NV-143; |
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announcements of technological innovations by us or our competitors; |
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new products introduced or announced by us or our competitors; |
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changes in financial estimates by securities analysts; |
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actual or anticipated variations in operating results; |
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expiration or termination of licenses, research contracts or other collaboration
agreements; |
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conditions or trends in the regulatory climate and the biotechnology, pharmaceutical and
genomics industries; |
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changes in the market valuations of similar companies; |
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the liquidity of any market for our securities; and |
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additional sales by us or Novogen of shares of our common stock. |
In addition, equity markets in general, and the market for biotechnology and life sciences
companies in particular, have experienced substantial price and volume fluctuations that have often
been unrelated or disproportionate to the operating performance of companies traded in those
markets. In addition, changes in economic conditions in the United States, Europe or globally,
could impact upon our ability to grow profitably. Adverse economic changes are outside our control
and may result in material adverse impacts on our business or our results of operations. These
broad market and industry factors may materially affect the market price of our shares of common
stock, regardless of our development and operating performance. In the past, following periods of
volatility in the market price of a companys securities, securities class-action litigation has
often been instituted against that company. Such litigation, if instituted against us, could cause
us to incur substantial costs and divert managements attention and resources.
Future sales of our common stock may depress our stock price and cause stockholders to experience
dilution.
The market price of our common stock could decline as a result of sales of substantial amounts
of our common stock in the public market, or the perception that these sales could occur.
We will have broad discretion over the use of the net proceeds to us from any exercise of
outstanding warrants.
We will have broad discretion to use the net proceeds to us upon any exercise of outstanding
warrants, and you will be relying on the judgment of our board of directors and management
regarding the application of these proceeds. Although we expect to use a substantial portion of the
net proceeds from any exercise of the warrants for general corporate purposes, including potential
payments to Novogen under the terms of the license agreements, potential licensing of other cancer
compounds developed by Novogen under the license option deed and potential expansion of the
clinical trial program for phenoxodiol to include other forms of cancer, we have not allocated
these net proceeds for specific purposes.
13
Risks Related to the Private Placement
If we fail to maintain registration of the common stock issued or issuable pursuant to the exercise
of warrants we issued in connection with the securities subscription agreement we entered into with
certain investors effective July 11, 2006, we may be obligated to pay the investors of those
securities liquidated damages.
In the event that the registration statement that was declared effective on September 5, 2006
ceases to be effective or usable at any time while shares of common stock covered by it remain
unsold or may only be sold subject to certain volume limitations, or investors are not permitted to
utilize the prospectus in connection with the registration statement to resell shares of common
stock covered by the registration statement, we will be obligated to pay investors who purchased
shares of common stock in the private placement liquidated damages equal to 1% of the aggregate
purchase price paid by each investor pursuant to the securities subscription agreement for any
shares of common stock or shares of common stock issuable upon exercise of warrants then held by
each investor per month (pro rated for any period less than a month) until the registration
statement is effective or the investors are permitted to utilize the prospectus in connection with
the registration statement to resell shares of common stock covered by the registration statement.
Liquidated damages paid to each investor in the private placement may not exceed more than 10%
of the purchase price paid by such investor for shares of common stock or shares of common stock
issuable upon exercise of warrants purchased under the securities subscription agreement. If we
become obligated to pay liquidated damages, we would deplete our limited working capital and
potentially need to raise additional funds. Additionally, the payment of liquated damages would
negatively impact our ability to complete future PIPEs.
If we fail to maintain registration of the common stock issued or issuable pursuant to the exercise
of warrants we issued in connection with the securities subscription agreement we entered into with
the selling stockholders (other than Blue Trading, LLC) effective August 1, 2007, we may be
obligated to pay such selling stockholders liquidated damages.
In connection with the securities subscription agreement we entered into with the selling
stockholders (other than Blue Trading, LLC) as of August 1, 2007, we entered into a registration
rights agreement pursuant to which we are obligated to file a resale registration statement with
the SEC by the fifth calendar day following the filing of the our Annual Report on Form 10-K for
the fiscal year ended June 30, 2007, covering the shares of common stock issued in connection with
the securities subscription agreement, in addition to the shares of common stock underlying the
warrants issued in connection with the securities subscription agreement.
In the event that the registration statement is not filed by the required filing date or that
the registration statement covering the registrable securities ceases to be effective or usable at
any time while shares of common stock covered by it remain unsold or may only be sold subject to
certain volume limitations, or the selling stockholders (other than Blue Trading, LLC) are not
permitted to utilize the prospectus in connection with the registration statement to resell shares
of common stock covered by the registration statement, we will be obligated to pay the selling
stockholders who purchased shares of common stock in the private placement liquidated damages equal
to 1% of the aggregate purchase price paid by each such selling stockholder pursuant to the
securities subscription agreement for any shares of common stock, shares of common stock issuable
upon exercise of warrants or warrants then held by each such selling stockholder per month (pro
rated for any period less than a month) until the registration statement is effective or such
selling stockholders are permitted to utilize the prospectus in connection with the registration
statement to resell shares of common stock covered by the registration statement.
Liquidated damages paid to the selling stockholders (other than Blue Trading, LLC) may not
exceed more than 10% of the purchase price paid by such selling stockholders for shares of common
stock purchased under the securities subscription agreement. If we become obligated to pay
liquidated damages, we would deplete our limited working capital and potentially need to raise
additional funds. Additionally, the payment of liquated damages would negatively impact our ability
to complete future PIPEs.
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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 inability to obtain any additional required financing or financing available to us
on acceptable terms; |
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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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our limited operating history; |
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uncertainties in clinical trial results; |
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our failure to successfully commercialize our product candidates; |
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the failure of any products to gain market acceptance; |
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competition and competitive factors; |
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our inability to control the costs of manufacturing our products; |
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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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continued cooperation and support of Novogen, our parent company; |
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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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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. |
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These risks are not exhaustive. Other sections of this prospectus may include additional
factors which could adversely impact our business and financial performance. Moreover, we operate
in a very competitive and rapidly changing environment. New risk factors emerge from time to time
and it is not possible for us to predict all risk factors, nor can we assess the impact of all
factors on our business or the extent to which any factor, or combination of factors, may cause
actual results to differ materially from those contained in any forward-looking statements.
You should not rely upon forward looking statements as predictions of future events. We cannot
assure you that the events and circumstances reflected in the forward looking statements will be
achieved or occur. Although we believe that the expectations reflected in the forward looking
statements are reasonable, we cannot guarantee future results, levels of activity, performance or
achievements.
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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 $8,613,244. 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.
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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
68,854,938 shares of our common stock issued and outstanding as of October 1, 2007, which includes
5,464,001 shares of our common stock covered by this prospectus, except where otherwise specified.
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 August 6, 2007, pursuant to a securities subscription agreement, we issued and sold
5,464,001 shares of our common stock and warrants exercisable for up to 2,185,598 additional shares
of our common stock. The common stock was sold at a price of $3.00 per share in a private placement
transaction for aggregate cash proceeds to us of $16,392,003. The warrants were received at no
additional charge by the investors in accordance with a ratio reflecting the number of shares of
common stock purchased by the respective investors. We also issued, as of August 6, 2007, 62,091
warrants exercisable for 248,364 shares of common stock to Blue Trading, LLC, which acted as the
placement agent in the private placement, as part of the placement fee. The warrants issued to the
investors pursuant to the securities subscription agreement have an exercise price of $3.60 per
share (subject to certain adjustments), whereas the warrants issued to Blue Trading, LLC have an
exercise price of $3.00 per share (subject to certain adjustments). With the exception of the
warrants issued to Blue Trading, LLC (which are immediately exercisable), the warrants may be
exercised no earlier than February 6, 2008, six months from the closing date. All of the warrants
will expire five years from the date of issuance, or August 6, 2012, 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.
All of the selling stockholders acquired the common stock and warrants to purchase common
stock, as the case may be, 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 stockholder 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.
18
The following table sets forth information with respect to the selling stockholders and the
shares of common stock and 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 the selling stockholders.
The number of shares of common stock included in the column below entitled Shares Beneficially
Owned Before Offering (Excluding New Warrant Shares)Number, for each such selling stockholder
does not include any shares of common stock issuable upon exercise of warrants issued to such
selling stockholder (other than Blue Trading, LLC) in connection with the securities subscription
agreement we entered into effective August 6, 2007 (the New Warrant Shares), as these warrants
are not exercisable until February 6, 2008; however, it does include shares of common stock
issuable upon exercise of warrants, if any, issued to such selling stockholder on July 11, 2006
(the Old Warrant Shares), which have an exercise price of $4.35 per share, expire on July 11,
2010 and are exercisable within 60 days. The number of shares of common stock included in the
column below entitled Shares Beneficially Owned Before Offering (Including New Warrant
Shares)Number for each such selling stockholder does include the New Warrant Shares of such
selling stockholder, despite the fact that these warrants (other than with respect to the warrants
of Blue Trading, LLC) are not exercisable until February 6, 2008, as well as the Old Warrant
Shares.
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares Beneficially |
|
Shares Beneficially |
|
|
|
|
|
|
|
|
|
|
|
|
Owned Before Offering |
|
Owned Before Offering |
|
|
|
|
|
|
|
|
|
Shares Beneficially |
|
|
(Excluding New Warrant |
|
(Including New Warrant |
|
Number of |
|
Owned |
|
|
Shares) |
|
Shares) |
|
Shares Being Offered |
|
After Offering |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common |
|
New Warrant |
|
|
|
Name |
|
Number |
|
%* |
|
Number** |
|
%* |
|
Stock Issued |
|
Shares |
|
Number |
|
%* |
|
DKR Saturn Event Driven
Holding Fund Ltd. |
|
|
500,000 |
|
|
|
* |
** |
|
|
700,000 |
(1) |
|
|
1.0 |
% |
|
|
500,000 |
|
|
|
200,000 |
|
|
|
|
|
|
|
|
|
El Coronado Holdings, LLC |
|
|
4,856,843 |
(2) |
|
|
6.95 |
% |
|
|
5,136,843 |
(3) |
|
|
7.32 |
% |
|
|
700,000 |
|
|
|
280,000 |
|
|
|
4,156,843 |
|
|
|
5.95 |
% |
Invus Public Equities L.P. |
|
|
166,667 |
|
|
|
* |
** |
|
|
233,334 |
(4) |
|
|
* |
** |
|
|
166,667 |
|
|
|
66,667 |
|
|
|
|
|
|
|
|
|
YA Global Investments,
L.P. (f/k/a Cornell
Capital Partners, L.P.) |
|
|
3,502,275 |
(5) |
|
|
5.01 |
% |
|
|
3,768,942 |
(6) |
|
|
5.37 |
% |
|
|
666,667 |
|
|
|
266,667 |
|
|
|
2,835,608 |
|
|
|
4.05 |
% |
Brencourt Multi-Strategy
Master, Ltd. |
|
|
1,302,559 |
(7) |
|
|
1.89 |
% |
|
|
1,793,227 |
(8) |
|
|
2.59 |
% |
|
|
1,226,667 |
|
|
|
490,668 |
|
|
|
75,892 |
|
|
|
* |
** |
MAN MAC Schreckhorn 13B
Ltd. |
|
|
849,225 |
(7) |
|
|
1.23 |
% |
|
|
1,158,557 |
(9) |
|
|
1.68 |
% |
|
|
773,333 |
|
|
|
309,332 |
|
|
|
75,892 |
|
|
|
* |
** |
Investcorp Event Fund
Limited |
|
|
342,559 |
(7) |
|
|
* |
** |
|
|
449,227 |
(10) |
|
|
* |
** |
|
|
266,667 |
|
|
|
106,668 |
|
|
|
75,892 |
|
|
|
* |
** |
Partners Group
Alternative Strategies |
|
|
289,225 |
(7) |
|
|
* |
** |
|
|
374,557 |
(11) |
|
|
* |
** |
|
|
213,333 |
|
|
|
85,332 |
|
|
|
75,892 |
|
|
|
* |
** |
Brencourt Multi-Stategy
Enhanced Dedicated Fund
L.P. |
|
|
262,559 |
(7) |
|
|
* |
** |
|
|
337,223 |
(12) |
|
|
* |
** |
|
|
186,667 |
|
|
|
74,664 |
|
|
|
75,892 |
|
|
|
* |
** |
OFITC International
Growth Fund |
|
|
65,730 |
(13) |
|
|
* |
** |
|
|
81,330 |
(14) |
|
|
* |
** |
|
|
39,000 |
|
|
|
15,600 |
|
|
|
26,730 |
|
|
|
* |
** |
AZL Oppenheimer
International Growth Fund |
|
|
287,245 |
(15) |
|
|
* |
** |
|
|
327,245 |
(16) |
|
|
* |
** |
|
|
100,000 |
|
|
|
40,000 |
|
|
|
187,245 |
|
|
|
* |
** |
Oppenheimer International
Growth Fund/VA |
|
|
420,060 |
(17) |
|
|
* |
** |
|
|
450,060 |
(18) |
|
|
* |
** |
|
|
75,000 |
|
|
|
30,000 |
|
|
|
345,060 |
|
|
|
* |
** |
Oppenheimer International
Growth Fund |
|
|
1,920,841 |
(19) |
|
|
2.76 |
% |
|
|
2,140,841 |
(20) |
|
|
3.08 |
% |
|
|
550,000 |
|
|
|
220,000 |
|
|
|
1,370,841 |
|
|
|
1.98 |
% |
Blue Trading, LLC |
|
|
248,364 |
(21) |
|
|
* |
** |
|
|
248,364 |
(21) |
|
|
* |
** |
|
|
|
|
|
|
248,364 |
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
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 68,854,938 shares
of common stock outstanding as of October 1, 2007 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 October 1, 2007,
3,063,622 shares of common
stock were subject to warrants exercisable within 60 days. |
|
** |
|
Includes the New Warrant Shares issuable upon exercise of warrants with an exercise
price of $3.60 per share expiring on August 6, 2012. Such warrants are not exercisable until
February 6, 2008. |
19
|
|
|
*** |
|
Less than 1% |
|
(1) |
|
Includes 200,000 shares of common stock issuable upon exercise of warrants with an
exercise price of $3.60 per share expiring on August 6, 2012. Such warrants are not
exercisable until February 6, 2008. The address of DKR Saturn Event Driven Holding Fund Ltd.
(the Fund) is c/o DKR Saturn Management L.P. is 1281 E. Main Street, Stamford, Connecticut
06902. The affairs of the Fund are managed DKR Saturn Management LP, its investment manager.
The investment manager has the authority to do any and all acts on behalf of the Fund,
including voting any shares held by the Fund. The principal who exercises investment control
over this selling stockholder is Mr. Ron Phillips, portfolio manager of DKR Saturn Management
LP. Mr. Phillips disclaims beneficial ownership of the shares. |
|
(2) |
|
Includes 3,098,843 shares of common stock owned by El Coronado Holdings, LLC with
Josiah T. Austin deemed beneficial owner as sole managing member and 8,000 shares of common
stock with Josiah T. Austin, trustee for certain family trusts prior to the private placement
on August 6, 2007 and 1,050,000 Old Warrant Shares owned by El Coronado Holdings, LLC issuable
upon exercise of warrants issued on July 11, 2006, which have an exercise price of $4.35 per
share, expire on July 11, 2010 and are exercisable within 60 days. |
|
(3) |
|
Includes 280,000 shares of common stock issuable upon exercise of warrants with an
exercise price of $3.60 per share expiring on August 6, 2012. Such warrants are not
exercisable until February 6, 2008. The address of El Coronado Holdings, LLC is 4801 E.
Broadway, Suite 501, Tucson, Arizona 85711. The principal who exercises investment control
over this selling stockholder is Josiah T. Austin. |
|
(4) |
|
Includes 66,667 shares of common stock issuable upon exercise of warrants with an
exercise price of $3.60 per share expiring on August 6, 2012. Such warrants are not
exercisable until February 6, 2008. The address of Invus Public Equities L.P. is 750
Lexington Avenue, 30th Floor, New York, New York 10022. The principal who exercises
investment control over this selling stockholder is Khalil Barrage. |
|
(5) |
|
Includes 1,752,849 shares of common stock owned by YA Global Investments, L.P.
(f/k/a Cornell Capital Partners, L.P.) prior to the private placement on August 6, 2007 and
1,082,759 Old Warrant Shares issuable upon exercise of warrants issued on July 11, 2006 to YA
Global Investments, L.P., which have an exercise price of $4.35 per share, expire on July 11,
2010 and are exercisable within 60 days. |
|
(6) |
|
Includes 266,667 shares of common stock issuable upon exercise of warrants with an
exercise price of $3.60 per share expiring on August 6, 2012. Such warrants are not
exercisable until February 6, 2008. The address of YA Global Investments, 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. |
|
(7) |
|
Includes 75,892 shares of common stock owned by William Collins, the chief executive
officer of Brencourt Advisors, LLC, the investment manager of this selling stockholder, prior
to the private placement on August 6, 2007. |
|
(8) |
|
Includes 490,668 shares of common stock issuable upon exercise of warrants with an
exercise price of $3.60 per share expiring on August 6, 2012. Such warrants are not
exercisable until February 6, 2008. The address of Brencourt Multi-Strategy Master, Ltd. is
c/o Brencourt Advisors, LLC, 600 Lexington Avenue, 8th Floor, New York, New York 10022. The
principal who exercises investment control over this selling stockholder is William Collins,
the chief executive officer of Brencourt Advisors, LLC, the investment manager of this selling
stockholder. |
|
(9) |
|
Includes 309,332 shares of common stock issuable upon exercise of warrants with an
exercise price of $3.60 per share expiring on August 6, 2012. Such warrants are not
exercisable until February 6, 2008. The address of MAN MAC Schreckhorn 13B, Ltd. is c/o
Brencourt Advisors, LLC, 600 Lexington Avenue, 8th Floor, New York, New York 10022. The
principal who exercises investment control over this selling stockholder is William Collins,
the chief executive officer of Brencourt Advisors, LLC, the investment manager of this selling
stockholder. |
|
(10) |
|
Includes 106,668 shares of common stock issuable upon exercise of warrants with an
exercise price of $3.60 per share expiring on August 6, 2012. Such warrants are not
exercisable until February 6, 2008. The address of Investcorp Event Fund Limited is c/o
Brencourt Advisors, LLC, 600 Lexington Avenue, 8th Floor, New York, New York 10022. The
principal who exercises investment control over this selling stockholder is William Collins,
the chief executive officer of Brencourt Advisors, LLC, the investment manager of this selling
stockholder. |
|
(11) |
|
Includes 85,332 shares of common stock issuable upon exercise of warrants with an
exercise price of $3.60 per share expiring on August 6, 2012. Such warrants are not
exercisable until February 6, 2008. The address of Partners Group Alternative Strategies is
c/o Brencourt Advisors, LLC, 600 Lexington Avenue, 8th Floor, New York, New York 10022. The
principal who exercises investment control over this selling stockholder is William Collins,
the chief executive officer of Brencourt Advisors, LLC, the investment manager of this selling
stockholder. |
|
(12) |
|
Includes 74,664 shares of common stock issuable upon exercise of warrants with an
exercise price of $3.60 per share expiring on August 6, 2012. Such warrants are not
exercisable until February 6, 2008. The address of Brencourt Multi-Stategy Enhanced
Dedicated Fund L.P. is c/o Brencourt Advisors, LLC, 600 Lexington Avenue, 8th Floor, New York,
New York 10022. The principal who exercises investment control over this selling stockholder
is William Collins, the chief executive officer of Brencourt Advisors, LLC, the investment
manager of this selling stockholder. |
|
(13) |
|
Includes 19,800 shares of common stock owned by the selling stockholder prior to
the private placement on August 6, 2007 and 6,930 Old Warrant Shares issuable upon exercise of
warrants issued on July 11, 2006, which have an exercise price of $4.35 per share, expire on
July 11, 2010 and are exercisable within 60 days. |
|
(14) |
|
Includes 15,600 shares of common stock issuable upon exercise of warrants with an
exercise price of $3.60 per share expiring on August 6, 2012. Such warrants are not
exercisable until February 6, 2008. The address of OFITC International Growth Fund is c/o
OppenheimerFunds, Inc., 6803 South Tucson Way, Centennial, Colorado 80112. The principal who
exercises investment control over this selling stockholder is George Evans, Senior Vice
President of OppenheimerFunds, Inc., which is an investment advisor registered under Section
203 of the Investment Advisors Act of 1940, as amended, that provides investment advisory
services to the selling stockholder. |
20
|
|
|
(15) |
|
Includes 138,700 shares of common stock owned by the selling stockholder prior to
the private placement on August 6, 2007 and 48,545 Old Warrant Shares issuable upon exercise
of warrants issued on July 11, 2006, which have an exercise price of $4.35 per share, expire
on July 11, 2010 and are exercisable within 60 days. |
|
(16) |
|
Includes 40,000 shares of common stock issuable upon exercise of warrants with an
exercise price of $3.60 per share expiring on August 6, 2012. Such warrants are not
exercisable until February 6, 2008. The address of AZL Oppenheimer International Growth Fund
is c/o OppenheimerFunds, Inc., 6803 South Tucson Way, Centennial, Colorado 80112. The
principal who exercises investment control over this selling stockholder is George Evans,
Senior Vice President of OppenheimerFunds, Inc., which is an investment advisor registered
under Section 203 of the Investment Advisors Act of 1940, as amended, that provides investment
advisory services to this selling stockholder. |
|
(17) |
|
Includes 255,600 shares of common stock owned by the selling stockholder prior to
the private placement on August 6, 2007 and 89,460 Old Warrant Shares issuable upon exercise
of warrants issued on July 11, 2006, which have an exercise price of $4.35 per share, expire
on July 11, 2010 and are exercisable within 60 days. |
|
(18) |
|
Includes 30,000 shares of common stock issuable upon exercise of warrants with an
exercise price of $3.60 per share expiring on August 6, 2012. Such warrants are not
exercisable until February 6, 2008. The address of Oppenheimer International Growth Fund/VA
is c/o OppenheimerFunds, Inc., 6803 South Tucson Way, Centennial, Colorado 80112. The
principal who exercises investment control over this selling stockholder is George Evans,
Senior Vice President of OppenheimerFunds, Inc., which is an investment advisor registered
under Section 203 of the Investment Advisors Act of 1940, as amended, that provides investment
advisory services to this selling stockholder. |
|
(19) |
|
Includes 1,015,438 shares of common stock owned by the selling stockholder prior
to the private placement on August 6, 2007 and 355,403 Old Warrant Shares issuable upon
exercise of warrants issued on July 11, 2006, which have an exercise price of $4.35 per share,
expire on July 11, 2010 and are exercisable within 60 days. |
|
(20) |
|
Includes 220,000 shares of common stock issuable upon exercise of warrants with an
exercise price of $3.60 per share expiring on August 6, 2012. Such warrants are not
exercisable until February 6, 2008. The address of Oppenheimer International Growth Fund is
c/o OppenheimerFunds, Inc., 6803 South Tucson Way, Centennial, Colorado 80112. The principal
who exercises investment control over this selling stockholder is George Evans, Senior Vice
President of OppenheimerFunds, Inc., which is an investment advisor registered under Section
203 of the Investment Advisors Act of 1940, as amended, that provides investment advisory
services to this selling stockholder. |
|
(21) |
|
Includes 248,364 shares of common stock issuable upon exercise of warrants with
an exercise price of $3.00 per share expiring on August 6, 2012. Such warrants are
immediately exercisable as of August 6, 2007. The address of Blue Trading, LLC is 70 East
55th Street, 22nd Floor, New York, New York 10022. The principal who exercises investment
control over this selling stockholder is Peter L. Getz, the president of Blue Trading, LLC. |
21
PLAN OF DISTRIBUTION
The selling stockholders and any of their pledgees, donees, assignees and
successors-in-interest may, from time to time, sell any or all of their shares of common stock
being offered under this prospectus on any stock exchange, market or trading facility on which
shares of our common stock are traded or in private transactions. These sales may be at fixed or
negotiated prices. The selling stockholders may use any one or more of the following methods when
disposing of shares:
|
|
|
ordinary brokerage transactions and transactions in which the broker-dealer solicits
purchasers; |
|
|
|
|
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; |
|
|
|
|
purchases by a broker-dealer as principal and resales by the broker-dealer for its
account; |
|
|
|
|
an exchange distribution in accordance with the rules of the applicable exchange; |
|
|
|
|
privately negotiated transactions; |
|
|
|
|
to cover short sales made after the date that the registration statement of which this
prospectus is a part is declared effective by the Commission; |
|
|
|
|
broker-dealers may agree with the selling stockholders to sell a specified number of
such shares at a stipulated price per share; |
|
|
|
|
a combination of any of these methods of sale; and |
|
|
|
|
any other method permitted pursuant to applicable law. |
The shares may also be sold under Rule 144 under the Securities Act of 1933, as amended
(Securities Act), if available, rather than under this prospectus. The selling stockholders have
the sole and absolute discretion not to accept any purchase offer or make any sale of shares if
they deem the purchase price to be unsatisfactory at any particular time.
The selling stockholders may pledge their shares to their brokers under the margin provisions
of customer agreements. If a selling stockholder defaults on a margin loan, the broker may, from
time to time, offer and sell the pledged shares.
Broker-dealers engaged by the selling stockholders may arrange for other broker-dealers to
participate in sales. Broker-dealers may receive commissions or discounts from the selling
stockholders (or, if any broker-dealer acts as agent for the purchaser of shares, from the
purchaser) in amounts to be negotiated, which commissions as to a particular broker or dealer may
be in excess of customary commissions to the extent permitted by applicable law.
If sales of shares offered under this prospectus are made to broker-dealers as principals, we
would be required to file a post-effective amendment to the registration statement of which this
prospectus is a part. In the post-effective amendment, we would be required to disclose the names
of any participating broker-dealers and the compensation arrangements relating to such sales.
The selling stockholders and any broker-dealers or agents that are involved in selling the
shares offered under this prospectus may be deemed to be underwriters within the meaning of the
Securities Act in connection with these sales. Commissions received by these 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. Any broker-dealers or agents that
are deemed to be underwriters may not sell shares offered under this prospectus unless and until we
set forth the names of the underwriters and the material details of their underwriting arrangements
in a
supplement to this prospectus or, if required, in a replacement prospectus included in a
post-effective amendment to the registration statement of which this prospectus is a part.
22
The selling stockholders and any other persons participating in the sale or distribution of
the shares offered under this prospectus will be subject to applicable provisions of the Exchange
Act, and the rules and regulations under that act, including Regulation M. These provisions may
restrict activities of, and limit the timing of purchases and sales of any of the shares by, the
selling stockholders or any other person. Furthermore, under Regulation M, persons engaged in a
distribution of securities are prohibited from simultaneously engaging in market making and other
activities with respect to those securities for a specified period of time prior to the
commencement of such distributions, subject to specified exceptions or exemptions. All of these
limitations may affect the marketability of the shares.
If any of the shares of common stock offered for sale pursuant to this prospectus are
transferred other than pursuant to a sale under this prospectus, then subsequent holders could not
use this prospectus until a post-effective amendment or prospectus supplement is filed, naming such
holders. We offer no assurance as to whether any of the selling stockholders will sell all or any
portion of the shares offered under this prospectus.
We have agreed to pay all fees and expenses we incur incident to the registration of the
shares being offered under this prospectus. However, each selling stockholder and purchaser is
responsible for paying any discounts, commissions and similar selling expenses they incur.
We and the selling stockholders have agreed to indemnify one another against certain losses,
damages and liabilities arising in connection with this prospectus, including liabilities under the
Securities Act.
23
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)
as of June 30, 2007 and June 30, 2006, and the related statements of operations, stockholders
equity and cash flows for each of the years in the three-year period ended June 30, 2007 and for
the period from December 1, 2000 (inception) through June 30, 2007, appearing in Marshall Edwards,
Inc.s Annual Report (Form 10-K) for the year ended June 30, 2007, are incorporated herein by
reference. The financial statements incorporated by reference in this prospectus have been audited
by BDO Kendalls (NSW), an independent registered public accounting firm, to the extent and for the
periods set forth in their report incorporated herein by reference, and are incorporated herein in
reliance upon such report given upon the authority of said firm as experts in auditing and
accounting.
24
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:
|
|
|
Our Annual Report on Form 10-K for the fiscal year ended June 30, 2007 filed on
September 27, 2007; |
|
|
|
|
Our Current Report on Form 8-K filed on July 30, 2007, and any amendments thereto; |
|
|
|
|
Our Current Report on Form 8-K filed on August 6, 2007, and any amendments thereto; |
|
|
|
|
Our Current Report on Form 8-K filed on August 21, 2007, and any amendments thereto; |
|
|
|
|
Our Current Report on Form 8-K/A filed on September 27, 2007, and any amendments
thereto; |
|
|
|
|
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.
25
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.
26
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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$ |
737.10 |
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Legal fees and expenses |
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90,000.00 |
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Accounting fees and expenses |
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15,000.00 |
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Miscellaneous fees and expenses |
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5,000.00 |
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Total |
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$ |
110,737.10 |
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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 |
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.* |
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10.1 |
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Securities Subscription Agreement, dated as of August 1, 2007, by and among
Marshall Edwards, Inc. and the purchasers signatory thereto(4) |
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10.2 |
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Registration Rights Agreement, dated as of August 6, 2007, by and among
Marshall Edwards, Inc. and the purchasers signatory thereto(5) |
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10.3 |
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Registration Rights Agreement, dated as of September 26, 2007, by and among
Marshall Edwards, Inc. and Blue Trading, LLC (6) |
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23.1 |
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Consent of Independent Registered Public Accounting Firm, BDO Kendalls (NSW)* |
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23.2 |
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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) |
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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 herein by reference to Exhibit 4.4 to the registrants annual report on
Form 10-K, filed with the SEC on September 27, 2007. |
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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
August 6, 2007, and to Exhibit 10.3 to the registrants current report on Form 8-K/A, filed
with the SEC on September 27, 2007. |
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(4) |
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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 August 6, 2007. |
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(5) |
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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
August 6, 2007. |
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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/A, filed with the SEC on September 27, 2007. |
Item 17. Undertakings
The undersigned registrant hereby undertakes:
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(1) |
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To file, during any period in which offers or sales are being made, a post-effective
amendment to this registration statement: |
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(i) |
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To include any prospectus required by Section 10(a)(3) of the Securities Act of
1933; |
II-2
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(ii) |
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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; |
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(iii) |
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To include any material information with respect to the plan of distribution
not previously 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. |
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(2) |
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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. |
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(3) |
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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. |
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(4) |
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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 registration statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in the City of Sydney, Australia, on this 2nd day of October, 2007.
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MARSHALL EDWARDS, INC. |
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By:
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/s/ Christopher Naughton |
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Christopher Naughton |
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President and Chief Executive Officer |
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POWER OF ATTORNEY
Each person whose individual signature appears below hereby authorizes and appoints
Christopher Naughton and David R. Seaton, and each of them, with full power of substitution and
resubstitution and full power to act without the other, as his or her true and lawful
attorney-in-fact and agent to act in his or her name, place and stead and to execute in the name
and on behalf of each person, individually and in each capacity stated below, and to file, any and
all amendments to this Registration Statement, including any and all post-effective amendments and
amendments thereto and any registration statement relating to the same offering as this
Registration Statement that is to be effective upon filing pursuant to Rule 462(b) under the
Securities Act of 1933, as amended, and to file the same, with all exhibits thereto, and other
documents in connection therewith, with the Securities and Exchange Commission, granting unto said
attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and
every act and thing, ratifying and confirming all that said attorneys-in-fact and agents or either
of them or their or his or her substitute or substitutes may lawfully do or cause to be done by
virtue thereof.
Pursuant to the requirements of the Securities Act of 1933, this registration statement has
been signed by the following persons in the capacities and on the dates indicated below.
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Signature |
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Title |
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Date |
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/s/ Christopher Naughton
Christopher Naughton
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President and Chief
Executive Officer,
Director (Principal
Executive Officer)
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October 2, 2007 |
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/s/ David R. Seaton
David R. Seaton
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Chief Financial Officer
and Secretary
(Principal Financial
Officer and Principal
Accounting Officer)
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October 2, 2007 |
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/s/ Philip A. Johnston
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Director
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October 2, 2007 |
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/s/ Bryan Williams
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Director
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October 2, 2007 |
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/s/ Paul J. Nestel
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Director
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October 2, 2007 |
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/s/ Stephen Breckenridge
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Director
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October 2, 2007 |
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II-4
EXHIBIT INDEX
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Exhibit |
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.* |
|
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|
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|
10.1 |
|
|
Securities Subscription Agreement, dated as of August 1, 2007, by and among
Marshall Edwards, Inc. and the purchasers signatory thereto(4) |
|
|
|
|
|
|
10.2 |
|
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Registration Rights Agreement, dated as of August 6, 2007, by and among
Marshall Edwards, Inc. and the purchasers signatory thereto(5) |
|
|
|
|
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10.3 |
|
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Registration Rights Agreement, dated as of September 26, 2007, by and among
Marshall Edwards, Inc. and Blue Trading, LLC (6) |
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23.1 |
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Consent of Independent Registered Public Accounting Firm, BDO Kendalls (NSW)* |
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23.2 |
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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) |
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* |
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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 herein by reference to Exhibit 4.4 to the registrants annual report on
Form 10-K, filed with the SEC on September 27, 2007. |
|
(3) |
|
Incorporated herein by reference to Exhibit 10.4 to the registrants current report
on Form 8-K, filed with the SEC on
August 6, 2007, and to Exhibit 10.3 to the registrants current report on Form 8-K/A, filed
with the SEC on September 27, 2007. |
|
(4) |
|
Incorporated herein by reference to Exhibit 10.1 to the registrants current report
on Form 8-K, filed with the SEC on August 6, 2007. |
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(5) |
|
Incorporated herein by reference to Exhibit 10.2 to the registrants current report on Form 8-K, filed with the SEC on
August 6, 2007. |
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(6) |
|
Incorporated herein by reference to Exhibit 10.2 to the registrants current report
on Form 8-K/A, filed with the SEC on September 27, 2007. |
exv5w1
Exhibit 5.1
October 2, 2007
Marshall Edwards, Inc.
140 Wicks Road
North Ryde, NSW, 2113
Australia
Re: Marshall Edwards, Inc. Registration Statement on Form S-3
Ladies and Gentlemen:
We have acted as counsel to Marshall Edwards, Inc., a Delaware corporation (the Company), in
connection with the preparation and filing of a registration statement on Form S-3, including the
exhibits thereto (the Registration Statement), with the U.S. Securities and Exchange Commission
(the Commission) under the Securities Act of 1933, as amended (the Act) and the prospectus
contained therein (the Prospectus) with respect to the proposed sale by the selling shareholders
named therein (the Selling Shareholders) of up to Seven Million Eight Hundred Ninety-Seven
Thousand Nine Hundred Sixty-Three (7,897,963) shares (the Shares) of the Companys common stock,
par value $0.00000002 (the Common Stock). The Shares consist of an aggregate of Five Million Four
Hundred Sixty-Four Thousand One (5,464,001) shares (the Issued Shares) of Common Stock currently
outstanding and beneficially owned by the Selling Shareholders and up to Two Million Four Hundred
Thirty-Three Thousand Nine Hundred Sixty-Two (2,433,962) shares (the Warrant Shares) issuable
upon the exercise of outstanding warrants (the Warrants) held by the Selling Shareholders. Except
as otherwise defined herein, capitalized terms are used as defined in the Registration Statement.
In connection with this opinion letter, we have reviewed the Registration Statement. In
addition, we have examined and relied upon the originals or copies certified or otherwise
identified to our satisfaction of: (i) the Companys Certificate of Incorporation, as amended to
date; (ii) the By-laws of the Company, as amended to date; (iii) records of the corporate
proceedings of the Company as we deemed necessary or appropriate as a basis for the opinions set
forth herein; (iv) the Amended and Restated Warrant Agreement, dated as of September 26, 2007, by
and among the Company, Computershare Inc. and Computershare Trust Company, N.A.; (v) the Warrant;
(vi) those matters of law as we have deemed necessary or appropriate as a basis for the opinions
set forth herein; and (vii) such other documents and records as we have deemed necessary.
In our examination of the aforesaid documents, we have assumed, without independent
investigation, the genuineness of all signatures, the legal capacity of all individuals who have
executed any of the documents, the authenticity of all documents submitted to us as originals, the
conformity to the original documents of all documents submitted to us as certified, photostatic,
reproduced or conformed copies and the authenticity of all such documents.
Based upon, the foregoing, we are of the opinion that:
1 The Issued Shares have been duly authorized and validly issued, fully paid and non-assessable; and
2 The Warrant Shares have been duly authorized and, when issued, delivered and paid for in
accordance with the Warrants, will be validly issued, fully paid and non-assessable.
We render the foregoing opinion as members of the Bar of the State of New York and express no
opinion as to laws other than the laws of the State of New York, the General Corporation Law of the
State of Delaware and the federal laws of the United States of America.
We hereby consent to the filing of this opinion as an exhibit to the Registration Statement
and to the use of our name under the caption Legal Matters. In giving this consent, we do not
admit that we are acting within the category of persons whose consent is required under Section 7
of the Act.
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Very truly yours,
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/s/ Morgan, Lewis & Bockius LLP |
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Morgan, Lewis & Bockius LLP |
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exv23w1
Exhibit 23.1
Marshall Edwards, Inc.
140 Wicks Road
NORTH RYDE NSW 2113
AUSTRALIA
Consent of Independent Registered Public Accounting Firm
We hereby consent to the incorporation by reference in the Prospectus constituting a part of this
Registration Statement of our report dated September 27, 2007, relating to the consolidated
financial statements appearing in the Companys Annual Report on Form 10-K for the year ended June
30, 2007.
We also consent to the reference to us under the caption Experts in the Prospectus.
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/s/ BDO Kendalls (NSW)
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Sydney, NSW, Australia |
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October 2, 2007 |
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