424B3: Prospectus filed pursuant to Rule 424(b)(3)
Published on November 21, 2006
Filed
pursuant to Rule 424(b)(3)
Registration
Nos. 333-133043
333-129744
PROSPECTUS
34,285,449
shares of common stock
NOVELOS
THERAPEUTICS, INC.
This
prospectus relates to the resale, from time to time, of up to 34,285,449 shares
of our common stock by the stockholders referred to throughout this prospectus
as “selling stockholders.” 14,785,697 shares of our common stock offered in this
prospectus are currently outstanding, 16,803,469 shares of our common stock
are
issuable upon exercise of warrants, and up to 2,696,283 shares of our common
stock are issuable upon conversion of preferred stock.
The
selling stockholders will receive all of the proceeds from the sales made under
this prospectus. Accordingly, we will receive no part of the proceeds from
sales
made under this prospectus. We are paying the expenses incurred in registering
the shares, but all selling and other expenses incurred by the selling
stockholders will be borne by the selling stockholders.
Our
common stock is quoted on the OTC Electronic Bulletin Board of the National
Association of Securities Dealers, Inc. under the symbol “NVLT.OB.” On November
15, 2006, the last reported sale price of our common stock on the OTC Electronic
Bulletin Board was $0.65 per share.
Investing
in our common stock involves a high degree of risk.
See
risk factors beginning on page 6 of this prospectus.
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 November 21, 2006
1
TABLE
OF CONTENTS
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Page
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|
PROSPECTUS
SUMMARY
|
4
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|
RISK
FACTORS
|
6
|
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|
FORWARD-LOOKING
STATEMENTS
|
16
|
|||
|
USE
OF PROCEEDS
|
16
|
|||
|
MARKET
FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
|
17
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|
MANAGEMENT'S
DISCUSSION AND ANALYSIS OR PLAN OF OPERATION
|
17
|
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|
BUSINESS
|
23
|
|||
|
MANAGEMENT
|
31
|
|||
|
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
|
38
|
|||
|
SELLING
STOCKHOLDERS
|
40
|
|||
|
DESCRIPTION
OF SECURITIES
|
52
|
|||
|
PLANS
OF DISTRIBUTION
|
54
|
|||
|
DISCLOSURE
OF COMMISSION POSITION ON INDEMNIFICATION FOR
SECURITIES
ACT LIABILITIES
|
57
|
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|
WHERE
YOU CAN FIND MORE INFORMATION
|
58
|
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|
LEGAL
MATTERS
|
58
|
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|
EXPERTS
|
58
|
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|
INDEX
TO FINANCIAL STATEMENTS
|
F-1
|
|||
2
No
dealer, salesperson or other person has been authorized to give any information
or to make any representations other than those contained in this prospectus
in
connection with the offer contained in this prospectus and, if given or
made,
such information or representations must not be relied upon as having been
authorized by us.
Neither
the delivery of this prospectus nor any sale made hereunder shall under
any
circumstances create an implication that there has been no change in our
affairs
since the date hereof. This prospectus does not constitute an offer to
sell or a
solicitation of an offer to buy securities other than those specifically
offered
hereby or of any securities offered hereby in any jurisdiction where, or
to any
person to whom, it is unlawful to make such offer or solicitation. The
information contained in this prospectus speaks only as of the date of
this
prospectus unless the information specifically indicates that another date
applies.
This
prospectus has been prepared based on information provided by us and by other
sources that we believe are reliable. This prospectus summarizes certain
documents and other information in a manner we believe to be accurate, but
we
refer you to the actual documents, if any, for a more complete understanding
of
what we discuss in this prospectus. In making a decision to invest in the common
stock, you must rely on your own examination of us and the terms of the offering
and the common stock, including the merits and risks involved.
We
are
not making any representation to you regarding the legality of an investment
in
our common stock under any legal investment or similar laws or regulations.
You
should not consider any information in this prospectus to be legal, business,
tax or other advice. You should consult your own attorney, business advisor
and
tax advisor for legal, business and tax advice regarding an investment in our
common stock.
3
PROSPECTUS
SUMMARY
The
following summary highlights certain material aspects of the offering for resale
of common stock by the selling stockholders covered by this prospectus but
may
not contain all of the information that is important to you. You should read
this summary together with the more detailed information regarding our company,
our common stock and our financial statements and notes to those statements
appearing elsewhere in this prospectus, including the “RISK FACTORS” beginning
on page 9.
Business
We
were
incorporated in June 1996 as AVAM International, Inc. In October 1998, Novelos
Therapeutics, Inc., a newly incorporated entity, merged into AVAM, and the
name
of AVAM was changed to Novelos Therapeutics, Inc. In June 2005, we merged with
Common Horizons, Inc., a Nevada Corporation. Following the merger, Common
Horizons, Inc. changed its state of incorporation, by-laws, certificate of
incorporation and fiscal year to that of Novelos and the surviving company
was
Novelos Therapeutics, Inc.
We
are a
biotechnology company commercializing oxidized glutathione-based compounds
for
the treatment of cancer and hepatitis. NOV-002, our lead compound, is currently
in Phase 3 development for lung cancer under a Special Protocol Assessment
and
Fast Track. NOV-002 is also in Phase 2 development for chemotherapy-resistant
ovarian cancer and early-stage breast cancer, and is also being developed for
acute radiation injury. NOV-205, our second compound, is in Phase 1b development
for chronic hepatitis C non-responders. Both compounds have completed clinical
trials in humans and have been approved for use in Russia where they were
originally developed.
NOV-002,
our lead compound, acts as a chemoprotectant and an immunomodulator. It is
marketed in Russia by ZAO BAM under the trade name Glutoxim®, and has been
administered to over 5,000 patients, demonstrating clinical efficacy and
excellent safety. The U.S.-based Phase 1/2 clinical trial of NOV-002 for
non-small cell lung cancer (NSCLC) has been completed and the treated group
demonstrated improved objective tumor response (defined as greater than 50%
tumor shrinkage) and higher tolerance of chemotherapy versus the control group.
During an End-of-Phase 2 meeting (December 2005), the FDA agreed with us that
advancing NOV-002 into a pivotal Phase 3 trial in advanced NSCLC, in combination
with first-line chemotherapy, is warranted. In May 2006, we finalized a Special
Protocol Assessment with the FDA for a single pivotal Phase 3 trial and obtained
Fast Track designation in August 2006. The primary endpoint of this trial is
overall survival, and we commenced patient enrollment in November 2006. In
a
1996-98 Russian NSCLC trial, NOV-002 increased the one-year survival rate from
17% to 63% when used in combination with chemotherapy. This result represents
an
80% improvement over the U.S. survival rate of 35% that results from the current
standard of care.
NOV-002
is also being developed to treat chemotherapy-resistant ovarian cancer. A U.S.
Phase 2 trial is ongoing at Massachusetts General Hospital and Dana-Farber
Cancer Institute. In a 1998 Russian review of case studies, NOV-002 sensitized
previously platinum-resistant ovarian cancer patients to chemotherapy. In
combination with NOV-002, 40% of the women responded favorably (partial or
complete response) to the same chemotherapy that had failed previously.
NOV-002
is also being developed to treat early-stage breast cancer. These patients
are
often treated with chemotherapy to minimize or avoid surgical intervention.
A
planned U.S. Phase 2 trial will evaluate the ability of NOV-002 to enhance
the
effectiveness of such chemotherapy while diminishing dose-limiting side-effects.
NOV-002
is also being developed to treat acute radiation injury.
NOV-205,
our second compound, acts as a hepatoprotective agent with immunomodulating
and
anti-inflammatory properties. Russian clinical studies completed in 1999 in
hepatitis B and C patients showed that after treatment with NOV-205, viral
load
was undetectable in a high proportion of patients and serum biochemical markers
of liver damage were significantly decreased. Our Investigational New Drug
Application for NOV-205 as mono-therapy for chronic hepatitis C has been
accepted by the FDA, and a U.S. Phase 1b trial in patients who previously failed
treatment with pegylated interferon plus ribavirin is ongoing.
4
Our
intellectual property portfolio includes four U.S. patents (plus a fifth
notice of allowance), two European patents and one Japanese issued
patent. Overall we have a total of thirty patent applications filed
worldwide, with coverage including composition of matter, method of use and
manufacturing. The breadth of the intellectual property will also allow us
to
expand our pipeline by claiming and commercializing additional compounds that
are based on oxidized glutathione.
We
have
devoted substantially all of our efforts towards the research and development
of
our product candidates. As of September 30, 2006, we have incurred approximately
$9.0 million in research and development expense since our inception. We have
had no revenue from product sales to date and have funded our operations through
the sale of equity securities and debt financings. From our inception through
September 30, 2006, we have raised approximately $29.0 million in equity and
debt financings. We have never been profitable and have incurred an accumulated
deficit of $21.0 million as of September 30, 2006.
The
Offering
|
Securities
Offered:
|
34,285,449
shares of our common stock including:
· 14,785,697
shares of our common stock currently outstanding,
· 16,803,469
shares of our common stock issuable upon exercise of warrants,
and
· 2,696,283
shares of our common stock issuable upon conversion of preferred
stock.
|
|
|
Use
of Proceeds:
|
We
will not receive any of the proceeds from the sale by any selling
stockholder of common stock or the conversion of preferred stock.
However,
we will receive proceeds from the exercise of the warrants if they
are
exercised by the selling stockholders. We intend to use any proceeds
for
working capital and general corporate purposes.
|
|
|
Total
Shares of our Common Stock
Outstanding
as of November
1, 2006:
|
39,235,272
|
Summary
Financial Information
The
following table provides selected financial and operating data for the years
ended December 31, 2005 and 2004 and the nine months ended September 30, 2006
and 2005.
|
Nine
Months Ended September 30,
|
Year
Ended
December
31,
|
||||||||||||
|
2006
|
2005
|
2005
|
2004
|
||||||||||
|
Revenue
|
$
|
-
|
$
|
12,584
|
$
|
12,584
|
$
|
4,962
|
|||||
|
Costs
and expenses
|
6,089,647
|
1,832,393
|
2,578,966
|
630,181
|
|||||||||
|
Other
income (expense)
|
476,523
|
(528,699
|
)
|
(487,017
|
)
|
(190,066
|
)
|
||||||
|
Net
loss
|
(5,613,124
|
)
|
(2,348,508
|
)
|
(3,053,399
|
)
|
(815,285
|
)
|
|||||
|
Net
loss attributable to common stockholders
|
(5,808,964
|
)
|
(4,291,885
|
)
|
(5,194,720
|
)
|
(952,093
|
)
|
|||||
|
Current
assets
|
14,293,353
|
5,658,097
|
4,801,925
|
102,571
|
|||||||||
|
Current
liabilities
|
1,107,767
|
695,569
|
217,156
|
4,443,804
|
|||||||||
|
Total
assets
|
14,330,362
|
5,689,413
|
4,938,699
|
108,571
|
|||||||||
Our
principal executive offices are located at One Gateway Center, Suite 504,
Newton, Massachusetts 02458 and our telephone number is (617)
244-1616.
5
RISK
FACTORS
The
following risk factors should be considered carefully in addition to the other
information contained in this prospectus:
Risks
Related to Our Business and Industry
We
may have difficulty raising needed capital because of our limited operating
history and business risks associated with us.
We
currently generate no revenue from our proposed products or otherwise. We do
not
know when this will change. We have expended and will continue to expend
substantial funds in the research, development and clinical and pre-clinical
testing of our drug compounds. We will require additional funds to conduct
research and development, establish and conduct clinical and pre-clinical
trials, establish commercial-scale manufacturing arrangements and provide for
the marketing and distribution of our products. Additional funds may not be
available on acceptable terms, if at all. If adequate funding is not available
to us, we may have to delay, reduce the scope of or eliminate one or more of
our
research or development programs or product launches or marketing efforts,
which
may materially harm our business, financial condition and results of
operations.
Our
long-term capital requirements are expected to depend on many factors,
including:
| · |
the
number of potential products and technologies in
development;
|
| · |
continued
progress and cost of our research and development
programs;
|
| · |
progress
with pre-clinical studies and clinical
trials;
|
| · |
the
time and costs involved in obtaining regulatory
clearance;
|
| · |
costs
involved in preparing, filing, prosecuting, maintaining and enforcing
patent claims;
|
| · |
costs
of developing sales, marketing and distribution channels and our
ability
to sell our drugs;
|
| · |
costs
involved in establishing manufacturing capabilities for clinical
trial and
commercial quantities of our drugs;
|
| · |
competing
technological and market
developments;
|
| · |
market
acceptance of our products;
|
| · |
costs
for recruiting and retaining management, employees and consultants;
|
| · |
costs
for training physicians;
|
| · |
our
status as a bulletin-board listed company and the prospects for our
stock
to be listed on a national exchange;
and
|
| · |
uncertainty
and economic instability resulting from terrorist acts and other
acts of
violence or war.
|
We
may
consume available resources more rapidly than currently anticipated, resulting
in the need for additional funding. We may seek to raise any necessary
additional funds through the issuance of warrants, equity or debt financings
or
executing collaborative arrangements with corporate partners or other sources,
which may be dilutive to existing stockholders or otherwise have a material
effect on our current or future business prospects. In addition, in the event
that additional funds are obtained through arrangements with collaborative
partners or other sources, we may have to relinquish economic and/or proprietary
rights to some of our technologies or products under development that we would
otherwise seek to develop or commercialize by ourselves. If adequate funds
are
not available, we may be required to significantly reduce or refocus our
development efforts with regard to our drug compounds. Currently, we believe
that we have available cash sufficient to meet our working capital requirements
into the third quarter of 2007, assuming our expense levels do not exceed our
current plan. If we do not generate revenues or raise additional capital, we
will not be able to sustain our operations at existing levels beyond that date
or earlier if expense levels increase.
6
The
failure to complete development of our therapeutic technology, obtain government
approvals, including required U.S. Food and Drug Administration (FDA) approvals,
or to comply with ongoing governmental regulations could prevent, delay or
limit
introduction or sale of proposed products and result in failure to achieve
revenues or maintain our ongoing business.
Our
research and development activities and the manufacture and marketing of our
intended products are subject to extensive regulation for safety, efficacy
and
quality by numerous government authorities in the United States and abroad.
Before receiving FDA clearance to market our proposed products, we will have
to
demonstrate that our products are safe and effective on the patient population
and for the diseases that are to be treated. Clinical trials, manufacturing
and
marketing of drugs are subject to the rigorous testing and approval process
of
the FDA and equivalent foreign regulatory authorities. The Federal Food, Drug
and Cosmetic Act and other federal, state and foreign statutes and regulations
govern and influence the testing, manufacturing, labeling, advertising,
distribution and promotion of drugs and medical devices. As a result, clinical
trials and regulatory approval can take many years to accomplish and require
the
expenditure of substantial financial, managerial and other
resources.
In
order
to be commercially viable, we must successfully research, develop, obtain
regulatory approval for, manufacture, introduce, market and distribute our
technologies. For each drug utilizing oxidized glutathione-based compounds,
including NOV-002 and NOV-205, we must successfully meet a number of critical
developmental milestones including:
| · |
demonstrating
benefit from delivery of each specific drug for specific medical
indications;
|
| · |
demonstrating
through pre-clinical and clinical trials that each drug is safe and
effective; and
|
| · |
demonstrating
that we have established a viable Good Manufacturing Process capable
of
potential scale-up.
|
The
time-frame necessary to achieve these developmental milestones may be long
and
uncertain, and we may not successfully complete these milestones for any of
our
intended products in development.
In
addition to the risks previously discussed, our technology is subject to
additional developmental risks that include the following:
| · |
uncertainties
arising from the rapidly growing scientific aspects of drug therapies
and
potential treatments;
|
| · |
uncertainties
arising as a result of the broad array of alternative potential treatments
related to cancer, hepatitis and other diseases;
and
|
| · |
anticipated
expense and time believed to be associated with the development and
regulatory approval of treatments for cancer, hepatitis and other
diseases.
|
In
order
to conduct the clinical trials that are necessary to obtain approval by the
FDA
to market a product, it is necessary to receive clearance from the FDA to
conduct such clinical trials. The FDA can halt clinical trials at any time
for
safety reasons or because we or our clinical investigators do not follow the
FDA’s requirements for conducting clinical trials. If we are unable to receive
clearance to conduct clinical trials or the trials are halted by the FDA, we
would not be able to achieve any revenue from such product, as it is illegal
to
sell any drug for human consumption in the U.S. without FDA approval.
7
Data
obtained from clinical trials is susceptible to varying interpretations, which
could delay, limit or prevent regulatory clearances.
Data
already obtained, or in the future obtained, from pre-clinical studies and
clinical trials does not necessarily predict the results that will be obtained
from later pre-clinical studies and clinical trials. Moreover, pre-clinical
and
clinical data are susceptible to varying interpretations, which could delay,
limit or prevent regulatory approval. A number of companies in the
pharmaceutical industry have suffered significant setbacks in advanced clinical
trials, even after promising results in earlier trials. The failure to
adequately demonstrate the safety and effectiveness of an intended product
under
development could delay or prevent regulatory clearance of the potential drug,
resulting in delays to commercialization, and could materially harm our
business. Our clinical trials may not demonstrate sufficient levels of safety
and efficacy necessary to obtain the requisite regulatory approvals for our
drugs, and our proposed drugs may not be approved for marketing.
We
may
encounter delays or rejections based upon additional government regulation
from
future legislation or administrative action or changes in FDA policy during
the
period of development, clinical trials and FDA regulatory review. We may
encounter similar delays in foreign countries. Sales of our products outside
the
U.S. would be subject to foreign regulatory approvals that vary from country
to
country. The time required to obtain approvals from foreign countries may be
shorter or longer than that required for FDA approval, and requirements for
foreign licensing may differ from FDA requirements. We may be unable to obtain
requisite approvals from the FDA and foreign regulatory authorities, and even
if
obtained, such approvals may not be on a timely basis, or they may not cover
the
uses that we request.
Even
if
we do ultimately receive FDA approval for any of our products, it will be
subject to extensive ongoing regulation. This includes regulations governing
manufacturing, labeling, packaging, testing, dispensing, prescription and
procurement quotas, record keeping, reporting, handling, shipment and disposal
of any such drug. Failure to obtain and maintain required registrations or
comply with any applicable regulations could further delay or preclude us from
developing and commercializing our drugs and subject us to enforcement
action.
Our
drugs or technology may not gain FDA approval in clinical trials or be effective
as a therapeutic agent, which could affect our future profitability and
prospects.
In
order
to obtain regulatory approvals, we must demonstrate that each drug is safe
and
effective for use in humans and functions as a therapeutic against the effects
of a disease or other physiological response. To date, studies conducted in
Russia involving our NOV-002 and NOV-205 products have shown what we believe
to
be promising results. In fact, NOV-002 has been approved for use in Russia
for
general medicinal use as an immunostimulant in combination with chemotherapy
and
antimicrobial therapy, and specifically for indications such as tuberculosis
and
psoriasis. NOV-205 has been approved in Russia as a mono-therapy agent for
the
treatment of hepatitis B and C. Russian regulatory approval is not equivalent
to
FDA approval. Pivotal Phase 3 studies with a large number of patients, typically
required for FDA approval, were not conducted for NOV-002 and NOV-205 in Russia.
Further, all of our Russian clinical studies were completed prior to 2000 and
may not have been conducted in accordance with current guidelines either in
Russia or the United States.
A
U.S.-based Phase 1/2 clinical study involving 44 non-small cell lung cancer
patients provided what we believe to be a favorable outcome. As a result, we
have enrolled the first patient in the Phase 3 study of NOV-002 for non-small
cell lung cancer in November 2006. We enrolled the first patient in the Phase
2
clinical study for NOV-002 for chemotherapy-resistant ovarian cancer in July
2006 and anticipate completing that study in 2007. We enrolled the first patient
in the Phase 1b clinical study for NOV-205 for chronic hepatitis C in September
2006 and we anticipate completing that study in 2007. There can be no assurance
that we can demonstrate that these products are safe or effective in advanced
clinical trials. We are also not able to give assurances that the results of
the
tests already conducted can be repeated or that further testing will support
our
applications for regulatory approval. As a result, our drug and technology
research program may be curtailed, redirected or eliminated at any
time.
8
There
is no guarantee that we will ever generate substantial revenue or become
profitable even if one or more of our drugs are approved for
commercialization.
We
expect
to incur increasing operating losses over the next several years as we incur
increasing costs for research and development and clinical trials. Our ability
to generate revenue and achieve profitability depends upon our ability, alone
or
with others, to complete the development of our proposed products, obtain the
required regulatory approvals and manufacture, market and sell our proposed
products. Development is costly and requires significant investment. In
addition, if we choose to license or obtain the assignment of rights to
additional drugs, the license fees for such drugs may increase our
costs.
To
date,
we have not generated any revenue from the commercial sale of our proposed
products or any drugs and do not expect to receive such revenue in the near
future. Our primary activity to date has been research and development. A
substantial portion of the research results and observations on which we rely
were performed by third parties at those parties’ sole or shared cost and
expense. We cannot be certain as to when or whether to anticipate
commercializing and marketing our proposed products in development, and do
not
expect to generate sufficient revenues from proposed product sales to cover
our
expenses or achieve profitability in the near future.
We
rely solely on research and manufacturing facilities at various universities,
hospitals, contract research organizations and contract manufacturers for all
of
our research, development, and manufacturing, which could be materially delayed
should we lose access to those facilities.
At
the
present time, we have no research, development or manufacturing facilities
of
our own. We are entirely dependent on contracting with third parties to use
their facilities to conduct research, development and manufacturing. Our
inability to have the facilities to conduct research, development and
manufacturing may delay or impair our ability to gain FDA approval and
commercialization of our drug delivery technology and products.
We
currently maintain a good working relationship with such contractors. Should
the
situation change and we are required to relocate these activities on short
notice, we do not currently have an alternate facility where we could relocate
our research, development and/or manufacturing activities. The cost and time
to
establish or locate an alternative research, development and manufacturing
facility to develop our technology would be substantial and would delay gaining
FDA approval and commercializing our products.
We
are dependent on our collaborative agreements for the development of our
technologies and business development, which exposes us to the risk of reliance
on the viability of third parties.
In
conducting our research, development and manufacturing activities, we rely
and
expect to continue to rely on numerous collaborative agreements with
universities, hospitals, governmental agencies, charitable foundations,
manufacturers and others. The loss of or failure to perform under any of these
arrangements, by any of these entities, may substantially disrupt or delay
our
research, development and manufacturing activities including our anticipated
clinical trials.
We
may
rely on third-party contract research organizations, service providers and
suppliers to support development and clinical testing of our products. Failure
of any of these contractors to provide the required services in a timely manner
or on reasonable commercial terms could materially delay the development and
approval of our products, increase our expenses and materially harm our
business, financial condition and results of operations.
We
are exposed to product, clinical and preclinical liability risks that could
create a substantial financial burden should we be sued.
Our
business exposes us to potential product liability and other liability risks
that are inherent in the testing, manufacturing and marketing of pharmaceutical
products. We cannot assure that such potential claims will not be asserted
against us. In addition, the use in our clinical trials of pharmaceutical
products that we may develop and then subsequently sell or our potential
collaborators may develop and then subsequently sell may cause us to bear a
portion of or all product liability risks. A successful liability claim or
series of claims brought against us could have a material adverse effect on
our
business, financial condition and results of operations.
9
Although
we have not received any product liability claims to date, we have an insurance
policy of $5,000,000 per occurrence and $5,000,000 in the aggregate to cover
such claims should they arise. There can be no assurance that material claims
will not arise in the future or that our insurance will be adequate to cover
all
situations. Moreover, there can be no assurance that such insurance, or
additional insurance, if required, will be available in the future or, if
available, will be available on commercially reasonable terms. Any product
liability claim, if successful, could have a material adverse effect on our
business, financial condition and results of operations. Furthermore, our
current and potential partners with whom we have collaborative agreements or
our
future licensees may not be willing to indemnify us against these types of
liabilities and may not themselves be sufficiently insured or have a net worth
sufficient to satisfy any product liability claims. Claims or losses in excess
of any product liability insurance coverage that may be obtained by us could
have a material adverse effect on our business, financial condition and results
of operations.
Acceptance
of our products in the marketplace is uncertain and failure to achieve market
acceptance will prevent or delay our ability to generate
revenues.
Our
future financial performance will depend, at least in part, upon the
introduction and customer acceptance of our proposed products. Even if approved
for marketing by the necessary regulatory authorities, our products may not
achieve market acceptance. The degree of market acceptance will depend upon
a
number of factors including:
| · |
the
receipt of regulatory clearance of marketing claims for the uses
that we
are developing;
|
| · |
the
establishment and demonstration of the advantages, safety and efficacy
of
our technologies;
|
| · |
pricing
and reimbursement policies of government and third-party payers such
as
insurance companies, health maintenance organizations and other health
plan administrators;
|
| · |
our
ability to attract corporate partners, including pharmaceutical companies,
to assist in commercializing our intended products;
and
|
| · |
our
ability to market our products.
|
Physicians,
patients, payers or the medical community in general may be unwilling to accept,
utilize or recommend any of our products. If we are unable to obtain regulatory
approval or commercialize and market our proposed products when planned, we
may
not achieve any market acceptance or generate revenue.
We
may face litigation from third parties who claim that our products infringe
on
their intellectual property rights, particularly because there is often
substantial uncertainty about the validity and breadth of medical
patents.
We
may be
exposed to future litigation by third parties based on claims that our
technologies, products or activities infringe the intellectual property rights
of others or that we have misappropriated the trade secrets of others. This
risk
is exacerbated by the fact that the validity and breadth of claims covered
in
medical technology patents and the breadth and scope of trade-secret protection
involve complex legal and factual questions for which important legal principles
are unresolved. Any litigation or claims against us, whether or not valid,
could
result in substantial costs, could place a significant strain on our financial
and managerial resources and could harm our reputation. Most of our license
agreements would likely require that we pay the costs associated with defending
this type of litigation. In addition, intellectual property litigation or claims
could force us to do one or more of the following:
| · |
cease
selling, incorporating or using any of our technologies and/or products
that incorporate the challenged intellectual property, which would
adversely affect our future
revenue;
|
| · |
obtain
a license from the holder of the infringed intellectual property
right,
which license may be costly or may not be available on reasonable
terms,
if at all; or
|
10
| · |
redesign
our products, which would be costly and
time-consuming.
|
If
we are unable to adequately protect or enforce our rights to intellectual
property or secure rights to third-party patents, we may lose valuable rights,
experience reduced market share, assuming any, or incur costly litigation to
protect such rights.
Our
ability to obtain licenses to patents, maintain trade secret protection and
operate without infringing the proprietary rights of others will be important
to
our commercializing any products under development. Therefore, any disruption
in
access to the technology could substantially delay the development of our
technology.
The
patent positions of biotechnology and pharmaceutical companies, including us,
that involve licensing agreements, are frequently uncertain and involve complex
legal and factual questions. In addition, the coverage claimed in a patent
application can be significantly reduced before the patent is issued or in
subsequent legal proceedings. Consequently, our patent applications and any
issued and licensed patents may not provide protection against competitive
technologies or may be held invalid if challenged or circumvented. Our
competitors may also independently develop products similar to ours or design
around or otherwise circumvent patents issued or licensed to us. In addition,
the laws of some foreign countries may not protect our proprietary rights to
the
same extent as U.S. law.
We
also
rely upon trade secrets, technical know-how and continuing technological
innovation to develop and maintain our competitive position. We generally
require our employees, consultants, advisors and collaborators to execute
appropriate confidentiality and assignment-of-inventions agreements. Our
competitors may independently develop substantially equivalent proprietary
information and techniques, reverse engineer our information and techniques,
or
otherwise gain access to our proprietary technology. We may be unable to
meaningfully protect our rights in trade secrets, technical know-how and other
non-patented technology.
Although
our trade secrets and technical know-how are important, our continued access
to
the patents is a significant factor in the development and commercialization
of
our products. Aside from the general body of scientific knowledge from other
drug delivery processes and technology, these patents, to the best of our
knowledge and based upon our current scientific data, are the only intellectual
property necessary to develop our products, including NOV-002 and NOV-205.
We do
not believe that we are or will be violating any patents in developing our
technology.
We
may
have to resort to litigation to protect our rights for certain intellectual
property, or to determine their scope, validity or enforceability. Enforcing
or
defending our rights is expensive, could cause diversion of our resources and
may not prove successful. Any failure to enforce or protect our rights could
cause us to lose the ability to exclude others from using our technology to
develop or sell competing products.
We
have limited manufacturing experience and, if our products are approved, we
may
not be able to manufacture sufficient quantities at an acceptable cost, or
may
be subject to risk that contract manufacturers could experience shut-downs
or
delays.
We
remain
in the research and development and clinical and pre-clinical trial phase of
product commercialization. Accordingly, if our products are approved for
commercial sale, we will need to establish the capability to commercially
manufacture our products in accordance with FDA and other regulatory
requirements. We have limited experience in establishing, supervising and
conducting commercial manufacturing. If we fail to adequately establish,
supervise and conduct all aspects of the manufacturing processes, we may not
be
able to commercialize our products.
We
presently plan to rely on third-party contractors to manufacture our products.
This may expose us to the risk of not being able to directly oversee the
production and quality of the manufacturing process. Furthermore, these
contractors, whether foreign or domestic, may experience regulatory compliance
difficulties, mechanical shutdowns, employee strikes or other unforeseeable
acts
that may delay production.
11
Due
to our limited marketing, sales and distribution experience, we may be
unsuccessful in our efforts to sell our products, enter into relationships
with
third parties or develop a direct sales organization.
We
have
not yet had to establish marketing, sales or distribution capabilities for
our
proposed products. Until such time as our products are further along in the
regulatory process, we will not devote any meaningful time and resources to
this
effort. At the appropriate time, we intend to enter into agreements with third
parties to sell our products or we may develop our own sales and marketing
force. We may be unable to establish or maintain third-party relationships
on a
commercially reasonable basis, if at all. In addition, these third parties
may
have similar or more established relationships with our
competitors.
If
we do
not enter into relationships with third parties for the sale and marketing
of
our products, we will need to develop our own sales and marketing capabilities.
We have limited experience in developing, training or managing a sales force.
If
we choose to establish a direct sales force, we may incur substantial additional
expenses in developing, training and managing such an organization. We may
be
unable to build a sales force on a cost-effective basis or at all. Any such
direct marketing and sales efforts may prove to be unsuccessful. In addition,
we
will compete with many other companies that currently have extensive marketing
and sales operations. Our marketing and sales efforts may be unable to compete
against these other companies. We may be unable to establish a sufficient sales
and marketing organization on a timely basis, if at all.
We
may be
unable to engage qualified distributors. Even if engaged, these distributors
may:
| · |
fail
to satisfy financial or contractual obligations to
us;
|
| · |
fail
to adequately market our products;
|
| · |
cease
operations with little or no notice;
or
|
| · |
offer,
design, manufacture or promote competing
products.
|
If
we
fail to develop sales, marketing and distribution channels, we would experience
delays in product sales and incur increased costs, which would harm our
financial results.
If
we are unable to convince physicians as to the benefits of our intended
products, we may incur delays or additional expense in our attempt to establish
market acceptance.
Achieving
broad use of our products may require physicians to be informed regarding these
products and their intended benefits. The time and cost of such an educational
process may be substantial. Inability to successfully carry out this physician
education process may adversely affect market acceptance of our products. We
may
be unable to timely educate physicians regarding our intended products in
sufficient numbers to achieve our marketing plans or to achieve product
acceptance. Any delay in physician education may materially delay or reduce
demand for our products. In addition, we may expend significant funds towards
physician education before any acceptance or demand for our products is created,
if at all.
Fluctuations
in foreign exchange rates could increase costs to complete international
clinical trial activities.
We
have
initiated a portion of our clinical trial activities in Europe. Significant
depreciation in the value of the U.S. Dollar against principally the Euro could
adversely affect our ability to complete the trials, particularly if we are
unable to redirect funding or raise additional funds. Since the timing and
amount of foreign-denominated payments are uncertain and dependent on a number
of factors, it is difficult to cost-effectively hedge the potential exposure.
Therefore, to date, we have not entered into any foreign currency hedges to
mitigate the potential exposure.
12
The
market for our products is rapidly changing and competitive, and new
therapeutics, new drugs and new treatments which may be developed by others
could impair our ability to maintain and grow our business and remain
competitive.
The
pharmaceutical and biotechnology industries are subject to rapid and substantial
technological change. Developments by others may render our technologies and
intended products noncompetitive or obsolete, or we may be unable to keep pace
with technological developments or other market factors. Technological
competition from pharmaceutical and biotechnology companies, universities,
governmental entities and others diversifying into the field is intense and
is
expected to increase. Many of these entities have significantly greater research
and development capabilities and budgets than we do, as well as substantially
more marketing, manufacturing, financial and managerial resources. These
entities represent significant competition for us. Acquisitions of, or
investments in, competing pharmaceutical or biotechnology companies by large
corporations could increase such competitors’ financial, marketing,
manufacturing and other resources.
We
are an
early-stage enterprise that operates with limited day-to-day business
management, operating as a vehicle to hold certain technology for possible
future exploration, and have been and will continue to be engaged in the
development of new drugs and therapeutic technologies. As a result, our
resources are limited and we may experience management, operational or technical
challenges inherent in such activities and novel technologies. Competitors
have
developed or are in the process of developing technologies that are, or in
the
future may be, the basis for competition. Some of these technologies may have
an
entirely different approach or means of accomplishing similar therapeutic
effects compared to our technology. Our competitors may develop drugs and drug
delivery technologies that are more effective than our intended products and,
therefore, present a serious competitive threat to us.
The
potential widespread acceptance of therapies that are alternatives to ours
may
limit market acceptance of our products even if commercialized. Many of our
targeted diseases and conditions can also be treated by other medication or
drug
delivery technologies. These treatments may be widely accepted in medical
communities and have a longer history of use. The established use of these
competitive drugs may limit the potential for our technologies and products
to
receive widespread acceptance if commercialized.
If
users of our products are unable to obtain adequate reimbursement from
third-party payers, or if new restrictive legislation is adopted, market
acceptance of our products may be limited and we may not achieve anticipated
revenues.
The
continuing efforts of government and insurance companies, health maintenance
organizations and other payers of healthcare costs to contain or reduce costs
of
health care may affect our future revenues and profitability, and the future
revenues and profitability of our potential customers, suppliers and
collaborative partners and the availability of capital. For example, in certain
foreign markets, pricing or profitability of prescription pharmaceuticals is
subject to government control. In the United States, given recent federal and
state government initiatives directed at lowering the total cost of health
care,
the U.S. Congress and state legislatures will likely continue to focus on health
care reform, the cost of prescription pharmaceuticals and on the reform of
the
Medicare and Medicaid systems. While we cannot predict whether any such
legislative or regulatory proposals will be adopted, the announcement or
adoption of such proposals could materially harm our business, financial
condition and results of operations.
Our
ability to commercialize our products will depend in part on the extent to
which
appropriate reimbursement levels for the cost of our products and related
treatment are obtained by governmental authorities, private health insurers
and
other organizations, such as health maintenance organizations (“HMO’s”).
Third-party payers are increasingly challenging the prices charged for medical
drugs and services. Also, the trend toward managed healthcare in the United
States and the concurrent growth of organizations such as HMO’s which could
control or significantly influence the purchase of healthcare services and
drugs, as well as legislative proposals to reform health care or reduce
government insurance programs, may all result in lower prices for or rejection
of our drugs. The cost containment measures that health care payers and
providers are instituting and the effect of any healthcare reform could
materially harm our ability to operate profitably.
13
We
depend upon key personnel who may terminate their employment with us at any
time, and we would need to hire additional qualified
personnel.
Our
success will depend to a significant degree upon the continued services of
key
management and advisors to us. There can be no assurance that these individuals
will continue to provide service to us. In addition, our success will depend
on
our ability to attract and retain other highly skilled personnel. We may be
unable to recruit such personnel on a timely basis, if at all. Our management
and other employees may voluntarily terminate their employment with us at any
time. The loss of services of key personnel, or the inability to attract and
retain additional qualified personnel, could result in delays in development
or
approval of our products, loss of sales and diversion of management resources.
Compliance
with changing corporate governance and public disclosure regulations may result
in additional expense.
Keeping
abreast of, and in compliance with, changing laws, regulations and standards
relating to corporate governance, public disclosure and internal controls,
including the Sarbanes-Oxley Act of 2002, new SEC regulations and, in the event
we seek and are approved for listing on a registered national securities
exchange, the stock exchange rules will require an increased amount of
management attention and external resources. We intend to continue to invest
all
reasonably necessary resources to comply with evolving standards, which may
result in increased general and administrative expense and a diversion of
management time and attention from revenue-generating activities to compliance
activities.
Risks
Related to our Common Stock
In
the time that our common stock has traded, our stock price has experienced
price
fluctuations.
There
can
be no assurance that the market price for our common stock will remain at its
current level and a decrease in the market price could result in substantial
losses for investors. The market price of our common stock may be significantly
affected by one or more of the following factors:
| · |
announcements
or press releases relating to the bio-pharmaceutical sector or to
our own
business or prospects;
|
| · |
regulatory,
legislative, or other developments affecting us or the healthcare
industry
generally;
|
| · |
the
dilutive effect of conversion of our Series A preferred stock into
common
stock at conversion rates or the exercise of options and warrants
at
below-current-market prices;
|
| · |
sales
by those financing our company through convertible securities and
warrants
of the underlying common stock, when it is registered with the SEC
and may
be sold into the public market, immediately upon conversion or exercise;
and
|
| · |
market
conditions specific to bio-pharmaceutical companies, the healthcare
industry and the stock market
generally.
|
There
may be a limited public market for our securities; we may fail to qualify for
listing on certain national securities exchanges.
We
have
filed applications for listing of our common stock on Archipelago and AMEX,
but
these applications were withdrawn primarily because our stock prices did not
meet the listing requirements. Although we may reapply, there can be no
assurance if and when initial listing criteria will be met or if such
applications will be granted, or that the trading of our common stock will
be
sustained. In the event that our common stock fails to qualify for initial
or
continued listing on a registered stock exchange or for initial or continued
inclusion in the NASDAQ system, trading, if any, in our common stock, would
then
continue to be conducted on the NASD’s electronic bulletin board in the
over-the-counter market and in what are commonly referred to as pink sheets.
As
a result, an investor may find it more difficult to dispose of or to obtain
accurate quotations as to the market value of our common stock, and our common
stock would become substantially less attractive for margin loans, for
investment by financial institutions, as consideration in future capital raising
transactions or other purposes.
14
Trading
of our common stock may be subject to penny-stock rules under the Securities
Exchange Act of 1934. Unless exempt, for any transaction involving a
penny-stock, the regulations require broker-dealers making a market in our
common stock to provide risk disclosure to their customers including regarding
the risks associated with our common stock, the suitability for the customer
of
an investment in our common stock, the duties of the broker-dealer to the
customer, information regarding prices for our common stock and any compensation
the broker-dealer would receive. The application of these rules may result
in
fewer market makers in our common stock. Our common stock is presently subject
to the rules on penny-stocks, and the liquidity of our common stock could be
materially adversely affected so long as we remain subject to such
rule.
Our
executive officers, directors and principal stockholders have substantial
holdings, which could delay or prevent a change in corporate control favored
by
our other stockholders.
Our
directors, officers and 5% stockholders beneficially own, in the aggregate,
approximately 34% of our outstanding voting stock. As a result, they may have
the ability to determine our direction and decisions. The interests of our
current officers and directors may differ from the interests of other
stockholders. Further, our current officers and directors may have the ability
to significantly affect the outcome of all corporate actions requiring
stockholder approval, including the following actions:
| · |
the
election of directors;
|
| · |
the
amendment of charter documents;
|
| · |
issuance
of blank-check preferred or convertible stock, notes or instruments
of
indebtedness which may have conversion, liquidation and similar features,
or effecting other financing arrangements;
or
|
| · |
the
approval of certain mergers and other significant corporate transactions,
including a sale of substantially all of our assets, or merger with
a
publicly-traded shell or other company.
|
Our
common stock could be further diluted as the result of the issuance of
additional shares of common stock, convertible securities, warrants or
options.
In
the
past, we have issued common stock, convertible securities, such as our Series
A
preferred stock, and warrants in order to raise money. We have also issued
options and warrants as compensation for services and incentive compensation
for
our employees and directors. We have a substantial number of shares of common
stock reserved for issuance upon the conversion and exercise of these
securities. Our issuance of additional common stock, convertible securities,
options and warrants could affect the rights of our stockholders, and could
reduce the market price of our common stock.
We
sold shares of our Series A preferred stock and common stock purchase warrants
in violation of certain provisions of our securities purchase agreement and
registration rights agreement executed in connection with our private placement
of units. While we have received waivers from such investors representing
approximately 96% of the outstanding units as of September 30, 2006, other
investors who do not waive such rights could sue us seeking damages arising
from
the breach of such agreements.
On
May
27, 2005, June 29, 2005, July 29, 2005 and August 9, 2005, we sold units,
consisting of shares of our common stock and common stock purchase warrants
pursuant to a securities purchase agreement and registration rights agreement.
The
registration rights agreement required us to file a registration statement
on
Form SB-2 with the SEC to register the shares of common stock and the shares
of
common stock issuable upon the exercise of the warrants on or before October
8,
2005. We filed the registration statement with the SEC on November 16, 2005,
which became effective on December 15, 2005. We recorded an accrued liability
of
$8,000 as of September 30, 2006 for payments in connection with this late
filing.
15
The
securities purchase agreement also prohibited us from effecting or entering
into
an agreement to effect any financing involving a variable rate transaction
for
two years.
The
use of the prospectus included in the Post-Effective Amendment No. 1 to the
Registration Statement on Form SB-2 (previously declared effective on April
3,
2006) and the prospectus included in the Registration Statement on Form SB-2
(previously declared effective on April 19, 2006) were suspended on October
24,
2006.
On
October 24, 2006, we filed a Current Report on Form 8-K which described an
error
in the financial statements and related notes to financial statements for the
quarter ended September 30, 2005 and the year ended December 31, 2005 relating
to the accounting and disclosure of the beneficial conversion feature of the
Company’s Series A 8% Cumulative Convertible Preferred Stock. On November 1,
2006 we filed amendments to the Annual Report on Form 10-KSB for the year ended
December 31, 2005 and the Quarterly Report on Form 10-QSB for the quarter ended
September 30, 2005. Following the filing of the Form 8-K on October 24, 2006,
we
advised the selling stockholders named in two registration statements related
to
the resale of securities purchased in private placement transactions in 2005
and
2006 that the use of the respective prospectuses had been suspended. We plan
to
amend these registration statements as soon as practicable to include the
restated financial statements. Pursuant to the registration rights associated
with these financings, we may become obligated to these selling stockholders
in
the event that the suspension of the use of the prospectuses exceeds the grace
periods specified. The amount of such obligation, if any, will not be determined
until later in the fourth quarter of 2006.
FORWARD-LOOKING
STATEMENTS
Except
for historical facts, the statements in this prospectus are forward-looking
statements. Forward-looking statements are merely our current predictions of
future events. These statements are inherently uncertain, and actual events
could differ materially from our predictions. Important factors that could
cause
actual events to vary from our predictions include those discussed under the
headings “Risk Factors,” “Management’s Discussion and Analysis or Plan of
Operation” and “Business.” We assume no obligation to update our forward-looking
statements to reflect new information or developments. We urge readers to review
carefully the risk factors described in this prospectus and the other documents
that we file with the Securities and Exchange Commission. You can read these
documents at www.sec.gov.
WE
UNDERTAKE NO OBLIGATION TO PUBLICLY UPDATE OR REVISE ANY FORWARD-LOOKING
STATEMENTS WHETHER AS A RESULT OF NEW INFORMATION, NEW EVENTS OR ANY OTHER
REASON, OR REFLECT ANY EVENTS OR CIRCUMSTANCES AFTER THE DATE OF THIS PROSPECTUS
OR THE DATE OF ANY APPLICABLE PROSPECTUS SUPPLEMENT THAT INCLUDES
FORWARD-LOOKING STATEMENTS.
USE
OF PROCEEDS
The
selling stockholders will receive all of the proceeds from the sale of the
shares offered for sale by them under this prospectus. We will not receive
any
proceeds from the resale of shares by the selling stockholders covered by this
prospectus. We will receive proceeds from the exercise of warrants. Such
proceeds will be used for working capital and general corporate
purposes.
16
MARKET
FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Market
Information
Our
common stock has been quoted on the OTC Electronic Bulletin Board of The
National Association of Securities Dealers, Inc. under the symbol “NVLT.OB”
since June 13, 2005. The following table provides, for the periods indicated,
the high and low bid prices for our common stock. These over-the-counter market
quotations reflect inter-dealer prices, without retail mark-up, mark-down or
commission, and may not represent actual transactions.
|
Fiscal
Year 2005
|
High
|
Low
|
|||||
|
First
Quarter
|
$
|
N/A
|
$
|
N/A
|
|||
|
Second
Quarter (beginning June 13, 2005)
|
2.80
|
2.20
|
|||||
|
Third
Quarter
|
4.47
|
2.16
|
|||||
|
Fourth
Quarter
|
3.65
|
1.53
|
|||||
|
Fiscal
Year 2006
|
High
|
Low
|
|||||
|
First
Quarter
|
$
|
2.25
|
$
|
1.60
|
|||
|
Second
Quarter
|
1.95
|
0.85
|
|||||
|
Third
Quarter
|
1.05
|
0.63
|
|||||
|
Fourth
Quarter (through November 15, 2006)
|
0.99
|
0.60
|
|||||
On
November 15, 2006, the closing sale price of our common stock as reported on
the
OTC Bulletin Board was $0.65 per share. On that date, we had approximately,
179
holders of record of our common stock. This number does not include stockholders
for whom shares were held in a “nominee” or “street” name.
We
have
not declared or paid any cash dividends on our common stock and do not
anticipate declaring or paying any cash dividends in the foreseeable future.
We
currently expect to retain future earnings, if any, for the development of
our
business. Dividends may be paid on our common stock only if and when declared
by
our board of directors after payment of any accrued dividends on our Series
A
preferred stock.
MANAGEMENT'S
DISCUSSION AND ANALYSIS OR PLAN OF OPERATION
Overview
We
are a
biotechnology company, established in 1996, commercializing oxidized
glutathione-based compounds for the treatment of cancer and hepatitis.
NOV-002,
our lead compound currently in Phase 3 development for non-small cell lung
cancer (NSCLC), acts as a chemoprotectant and an immunomodulator. In May 2006,
we finalized a Special Protocol Assessment (SPA) with the FDA for a single
pivotal Phase 3 trial in advanced NSCLC in combination with first-line
chemotherapy, and received Fast Track designation in August 2006. The primary
endpoint of this trial will be overall survival and patient enrollment commenced
in November 2006. NOV-002 is also in Phase 2 development for
chemotherapy-resistant ovarian cancer and early-stage breast cancer, and, in
addition, is being developed for treatment of acute radiation injury.
NOV-205,
our second compound, acts as a hepatoprotective agent with immunomodulating
and
anti-inflammatory properties. Our Investigational New Drug Application for
NOV-205 as mono-therapy for chronic hepatitis C has been accepted by the FDA,
and a U.S. Phase 1b clinical trial in patients who previously failed treatment
with pegylated interferon plus ribavirin is ongoing.
Both
compounds have completed clinical trials in humans and have been approved for
use in Russia where they were originally developed. We own all intellectual
property rights worldwide (excluding Russia and other states of the former
Soviet Union) related to compounds based on oxidized glutathione, including
NOV-002 and NOV-205. Our patent portfolio includes four U.S. issued patents
(plus one notice of allowance), two European issued patents and one
Japanese issued patent.
17
We
have
devoted substantially all of our efforts towards the research and development
of
our product candidates. As of September 30, 2006, we have incurred approximately
$9.3 million in research and development expense since our inception. We have
had no revenue from product sales to date and have funded our operations through
the sale of equity securities and debt financings. From our inception through
September 30, 2006, we have raised approximately $29.0 million in equity and
debt financings. We have never been profitable and have incurred an accumulated
deficit of $21.0 million as of September 30, 2006.
On
May
26, 2005, we restructured certain of our indebtedness. We exchanged indebtedness
of $3,139,185 for 586,352 shares of our common stock with an aggregate deemed
value of $732,940, $318,714 in cash, and forgiveness of debt of $2,087,531.
Also
on May 26, 2005, holders of $1,100,000 of convertible notes payable exercised
their option to convert their notes into 1,760,000 shares of common stock at
a
price of $0.625 per share. On May 26, 2005, we also revised certain of our
royalty obligations. As a result, we issued 2,016,894 shares of our common
stock
with an aggregate deemed value of $2,521,118.
Following
the restructuring of debt, the Company completed a reverse merger with
Common
Horizons, Inc. (“Common Horizons”), a Nevada-based developer of web portals. In
connection with that transaction, all outstanding shares of Novelos (net of
shares of treasury stock) were converted into an equal number of shares of
common stock of Common Horizons and all outstanding options and warrants to
purchase shares of Novelos common stock were converted into an equal number
of
options and warrants to purchase shares of Common Horizons with the same terms
and conditions as the original options and warrants. In connection with the
merger all but 4,500,000 shares of outstanding common stock of Common Horizons
were canceled. Common Horizons changed its state of incorporation, by-laws,
certificate of incorporation and fiscal year to that of Novelos and Novelos
became the surviving corporation. The business of Common Horizons, which was
insignificant, was abandoned and the business of Novelos was adopted. The
transaction was therefore treated as a reverse acquisition recapitalization
with
Novelos as the acquiring party and Common Horizons as the acquired party for
accounting purposes. Accordingly, all historical information in these
financial statements is that of the Novelos business. The results of operations
of Common Horizons prior to the merger were not material for purposes of pro
forma presentation. The 4,500,000 remaining shares of Common Horizons
outstanding at the completion of the merger, net of cancellations, were deemed,
for accounting purposes, to be an issuance by Novelos. Since Common Horizons
had
no remaining financial assets or liabilities, the merger with Common Horizons
did not have any significant effects on the Company’s assets or liabilities or
on the Company’s results of operations subsequent to the date of the merger.
During
2005 and 2006 we completed various private placements of securities. In May
through August of 2005 we sold an aggregate of 4,000,000 shares of common stock
and warrants to purchase 2,000,000 shares of common stock for net cash proceeds
of $3,714,468 and the conversion of $550,000 of convertible debt. In
September and October 2005, we sold in a private placement 3,200 shares of
Series A preferred stock and warrants to purchase 909,090 shares of common
stock
for aggregate net proceeds of $2,864,000. The preferred stock was initially
convertible into 1,939,393 shares of common stock, and is currently convertible
into 2,370,370, shares of common stock due to certain adjustments to the
conversion price. On
March
7, 2006, we sold 11,154,073 shares of our common stock and warrants to purchase
8,365,542 shares of our common stock for net proceeds of $13,847,000.
Critical
Accounting Policies
The
preparation of financial statements and related disclosures in conformity with
accounting principles generally accepted in the United States (GAAP) requires
management to make certain estimates, judgments and assumptions that affect
the
reported amounts of assets and liabilities as of the date of the financial
statements, as well as the reported amounts of revenues and expenses during
the
periods presented. Actual results could differ from those estimates. We review
these estimates and assumptions periodically and reflect the effects of
revisions in the period that they are determined to be necessary.
18
We
believe that the following accounting policies reflect our more significant
judgments and estimates used in the preparation of our financial statements.
Accrued
Expenses. As
part
of the process of preparing financial statements, we are required to estimate
accrued expenses. This process involves identifying services that have been
performed on our behalf, and estimating the level of service performed and
the
associated cost incurred for such service as of each balance sheet date in
our
financial statements. Examples of estimated expenses for which we accrue
include: contract service fees such as amounts paid to clinical monitors; data
management organizations and investigators in conjunction with clinical trials;
fees paid to contract manufacturers in conjunction with the production of
clinical materials; consulting fees; and professional service fees, such as
for
lawyers and accountants. In connection with such service fees, our estimates
are
most affected by our understanding of the status and timing of services provided
relative to the actual levels of services incurred by such service providers.
The majority of our service providers invoice us monthly in arrears for services
performed. In the event that we do not identify certain costs that have begun
to
be incurred, or we over- or underestimate the level of services performed or
the
costs of such services, our reported expenses for such period would be too
low
or too high. The date on which certain services commence, the level of services
performed on or before a given date and the cost of such services are often
determined based on subjective judgments. We make these judgments based upon
the
facts and circumstances known to us in accordance with generally accepted
accounting principles.
Stock-Based
Compensation. Commencing
on January 1, 2006 we began applying the provisions of SFAS 123R in accounting
for stock-based compensation. SFAS 123R requires measurement of the cost of
employee services received in exchange for an award of equity instruments based
on the grant-date fair value of the award. That cost is recognized over the
period during which an employee is required to provide service in exchange
for
the award, the requisite service period (usually the vesting period). Prior
to
January 1, 2006, we followed Accounting Principles Board (APB), Opinion No.
25,
Accounting
for Stock Issued to Employees,
or APB
25, and related interpretations, in accounting for our stock-based compensation
plans, rather than the alternative fair-value method provided for under SFAS
No.
123, Accounting
for Stock-Based Compensation,
or SFAS
123. In the notes to our financial statements, we provide pro-forma disclosures
in accordance with SFAS 123. We account for transactions in which services
are
received from non-employees in exchange for equity instruments based on the
fair
value of such services received or of the equity instruments issued, whichever
is more reliably measured, in accordance with SFAS 123 and the Emerging Issues
Task Force (EITF) Issue 96-18, Accounting
for Equity Instruments That Are Issued to Other than Employees for Acquiring,
or
in Conjunction with Selling, Goods or Services,
or EITF
96-18.
Accounting
for equity instruments granted or sold by us under APB 25, SFAS 123, SFAS 123R
and EITF 96-18 requires fair-value estimates of the equity instrument granted
or
sold. If our estimates of the fair value of these equity instruments are too
high or too low, our expenses may be over- or understated. For equity
instruments granted or sold in exchange for the receipt of goods or services,
we
estimate the fair value of the equity instruments based on consideration of
factors that we deem to be relevant at that time. Because shares of our common
stock were not publicly traded prior to the corporate restructuring described
in
Note 3 to the financial statements, market factors historically considered
in
valuing stock and stock option grants included corresponding values of
comparable public companies discounted for the risk and limited liquidity
provided for in the shares we are issuing; pricing of private sales of our
convertible preferred stock; prior valuations of stock grants and the effect
of
events that occurred between the times of such grants; economic trends; and
the
comparative rights and preferences of the security being granted compared to
the
rights and preferences of our other outstanding equity.
Prior
to
our corporate restructuring, the fair value of our common stock was determined
by our board of directors contemporaneously with the grant. In the absence
of a
public trading market for our common stock, our board of directors considered
numerous objective and subjective factors in determining the fair value of
our
common stock. At the time of option grants and other stock issuances, our board
of directors considered the liquidation preferences, dividend rights, voting
control and anti-dilution protection attributable to our then-outstanding
convertible preferred stock; the status of private and public financial markets;
valuations of comparable private and public companies; the likelihood of
achieving a liquidity event such as an initial public offering; our existing
financial resources; our anticipated continuing operating losses and increased
spending levels required to complete our clinical trials; dilution to common
stockholders from anticipated future financings; and a general assessment of
future business risks.
19
Results
of Operations
Research
and development expense.
Research
and development expense consists of costs incurred in identifying, developing
and testing product candidates, which primarily consist of salaries and related
expenses for personnel, fees paid to professional service providers for
independent monitoring and analysis of our clinical trials, costs of contract
research and manufacturing, and costs to secure intellectual property. We
currently have two compounds, NOV-002 and NOV-205. However, to date, most of
our
research and development costs have been associated with our NOV-002
compound.
General
and administrative expense.
General
and administrative expense consists primarily of salaries and other related
costs for personnel in executive, finance and administrative functions. Other
costs include facility costs, insurance, costs for public and investor
relations, directors’ fees and professional fees for legal and accounting
services.
Nine
Months Ended September 30, 2006 and 2005
Research
and Development.
Research
and development expense for the nine months ended September 30, 2006 was
$4,200,000 compared to $927,000 for the nine months ended September 30, 2005.
The $3,273,000, or 353%, increase in research and development expense was
primarily due to increased funding of our clinical, contract manufacturing
and
non-clinical activities. In particular, activities relating to the commencement
of our pivotal Phase 3 clinical trial of NOV-002 for non-small cell lung cancer
resulted in increased expenses during the nine months ended September 30, 2006,
including an increase of $1,522,000 for contract research and consulting
services and an increase of $259,000 in drug manufacturing costs. We also
purchased $864,000 of chemotherapy drugs during the third quarter of 2006 to
be
used in the Phase 3 clinical trial, specifically for European and Eastern
European clinical sites. Since we do not anticipate recovering any of the costs
of the chemotherapy and we do not have a reliable method for tracking the drugs
that have been administered to patients or evaluating any losses associated
with
spoilage, we recorded the entire amount as an expense in the period purchased.
As disclosed in Note 10, we have a commitment to purchase an additional $1.8
million of chemotherapy drugs at specified intervals through March 2008.
Additionally, as a result of hiring that occurred during the third quarter
of
2005, research and development salaries and related costs also increased
$487,000 in the first nine months of 2006 compared to the same period in 2005.
Lastly, stock compensation expense increased $76,000 during the first nine
months of 2006 compared to the first nine months of 2005 relating to stock
option grants principally resulting from the adoption of SFAS 123R in January
2006.
General
and Administrative.
General
and administrative expense for the nine months ended September 30, 2006 was
$1,889,000 compared to $905,000 for the nine months ended September 30, 2005.
The $984,000, or 109%, increase in general and administrative expense was
primarily due to increased costs associated with corporate governance and
periodic filing requirements as a public company, increased overhead costs
to
support the research activities described above, as well as expanded investor
relations activities. The total increase includes an increase of $346,000 in
compensation and directors’ fees; an increase of $389,000 in public and investor
relations costs and public company recordkeeping costs (including a $174,000
increase in non-cash stock compensation related to restricted stock awards);
an
increase of $190,000 related to professional and consulting fees; and an
increase of $30,000 in insurance costs. We also incurred an increase of $171,000
in non-cash stock compensation expense related to stock option grants and an
increase of $80,000 in travel and overhead expenses. These increases were offset
in 2006 by a $225,000 reduction in accrued registration filing penalties that
were recorded in the first nine months of 2005. However, waivers from the
associated requirements were received from certain stockholders and the accrual
was reduced in the fourth quarter of 2005.
Interest
Income.
Interest
income for the nine months ended September 30, 2006 was $472,000 compared to
$10,000 for the nine months ended September 30, 2005. The increase in interest
income during the nine months ended September 30, 2006 related to higher average
cash balances in 2006, as a result of the financings described in Notes 3 and
5
being placed in interest-bearing accounts.
20
Interest
Expense.
Interest
expense for the nine months ended September 30, 2006 was $0 compared to $109,000
for the nine months ended September 30, 2005. The decrease was due to all
interest-bearing debt balances being paid off during 2005.
Gain
on Forgiveness of Debt.
Gain on
forgiveness of debt for the nine months ended September 30, 2006 was $0 compared
to $2,087,531 for the nine months ended September 30, 2005. On May 26, 2005,
we
exchanged indebtedness of $3,139,185 for 586,352 shares of our common stock
with
an aggregate deemed value of $732,940 and $318,714 in cash, which resulted
in
forgiveness of debt income of $2,087,531.
Restructuring
Expense.
Restructuring expense for the nine months ended September 30, 2006 was $0
compared to $2,521,118 for the nine months ended September 30, 2005. On May
26,
2005, we revised an arrangement that requires us to pay future royalties, which
resulted in the issuance of 2,016,894 shares of our common stock with an
aggregate deemed value of $2,521,118.
Preferred
Stock Dividends and Deemed Dividend. During
the nine months ended September 30, 2006 we paid dividends to preferred
stockholders of $195,840.
There
were no dividends paid to preferred stockholders in the nine months ended
September 30, 2005, but during that period we recorded a deemed dividend to
preferred stockholders of $1,943,377. This amount represents the value
attributed to the beneficial conversion feature of the Series A 8% Cumulative
Convertible Preferred Stock issued in September 2005.
There
were no deemed dividends in the nine months ended September 30,
2006.
The
deemed dividends and cash dividends have been included in the calculation of
net
loss
attributable to common stockholders for the respective periods.
Years
Ended December 31, 2005 and 2004
Revenue.
Revenue
for the year ended December 31, 2005 was $12,584 compared to $4,962 for the
year
ended December 31, 2004. The 2005 amount represented the recognition of a prior
year’s deferred revenue on sales of bulk drug samples to facilitate research
activities. This revenue represents recognition of the remaining installment
due
on bulk drug sample sales. In lieu of cash, we accepted research and development
services as final payment.
Research
and Development.
Research
and development expense for the year ended December 31, 2005 was $1,136,217
compared to $261,768 for the year ended December 31, 2004. The $874,449, or
334%, increase in research and development expense was primarily due to
increased funding of our preclinical, clinical and contract manufacturing
activities, an increase in compensation costs due to an increase in headcount,
and an increase in stock-based compensation. The private placement transactions,
corporate restructuring and issuance of promissory notes during the year ended
December 31, 2005 allowed us to engage outside consultants and organizations
to
further research, develop and test our product candidates.
General
and Administrative.
General
and administrative expense for the year ended December 31, 2005 was $1,442,749
compared to $368,413 for the year ended December 31, 2004. The $1,074,336,
or
292%, increase in general and administrative expense was primarily due to our
periodic filing obligations and increases in professional and consulting fees,
public and investor relations and public company recordkeeping. We also incurred
additional legal and consulting costs during the year ended December 31, 2005
in
translating and filing our European patent applications. As described in Note
3
to our financial statements, we also recorded a $33,000 expense during the
year
ended December 31, 2005 relating to the late filing of a registration statement
associated with our sale of units.
Consulting
Revenue. Consulting
revenue for the year ended December 31, 2005 was $0 compared to $13,374 for
the
year ended December 31, 2004. Consulting revenue recorded during the year ended
December 31, 2004 primarily related to one consulting engagement that ended
during the quarter ended June 30, 2004.
Interest
Income. Interest
income for the year ended December 31, 2005 was $49,876 compared to $95 for
the
year ended December 31, 2004. The
increase in interest income during the year ended December 31, 2005 over the
comparable period in 2004 related to higher average cash balances in 2005,
as a
result of the financings described in Notes 3 and 5 to our financial statements,
being placed in interest-bearing accounts.
21
Interest
Expense. Interest
expense for the year ended December 31, 2005 was $109,102 compared to $208,741
for the year ended December 31, 2004. The $99,639, or 48%, decrease was due
to
lower average debt balances during the 2005 period.
Gain
on Forgiveness of Debt. Gain
on
forgiveness of debt for the year ended December 31, 2005 was $2,087,531 compared
to $0 for the year ended December 31, 2004. On May 26, 2005, we exchanged
indebtedness of $3,139,185 for 586,352 shares of our common stock with an
aggregate deemed value of $732,940 and $318,714 in cash, which resulted in
forgiveness of debt income of $2,087,531.
Restructuring
Expense. Restructuring
expense for the year ended December 31, 2005 was $2,521,118 compared to $0
for
the year ended December 31, 2004. On May 26, 2005, we revised an arrangement
that requires us to pay future royalties, which resulted in the issuance of
2,016,894 shares of our common stock with an aggregate deemed value of
$2,521,118.
Preferred
Stock Dividends and Deemed Dividend. In
the
year ended December 31, 2005 we recorded a deemed dividend to preferred
stockholders of $2,077,321. This amount represents the value attributed to
the
beneficial conversion feature of the Series A 8% Cumulative Convertible
Preferred Stock issued during that period.
In the
year ended December 31, 2005, we also paid $64,000 in dividends to preferred
stockholders in the form of additional shares of preferred stock. These amounts
have been included in the calculation of net
loss
attributable to common stockholders for the year ended December 31, 2005. There
were no dividends or deemed dividends in the year ended December 31, 2004.
Liquidity
and Capital Resources
We
have
financed our operations since inception through the sale of equity securities
and the issuance of debt. As of September 30, 2006, we had $13,922,000 in cash
and equivalents, including $2,211,000 of restricted cash that is reserved for
research and development activities.
During
the nine months ended September 30, 2006, cash of approximately $4,206,000
was
used in operations, primarily due to a net loss of $5,613,000, offset by
non-cash stock-based compensation expense of $462,000, depreciation and
amortization of $7,000, a decrease in prepaid expenses of $47,000 and an
increase in accounts payable and accrued expenses of $891,000. During the nine
months ended September 30, 2006, cash of approximately $2,001,000 was used
in
investing activities primarily due to the outstanding pledge of $2,058,000
in
cash and equivalents associated with a letter of credit agreement with a bank
as
described in Note 10.
During
the nine months ended September 30, 2006, cash of approximately $13,652,000
was
provided by financing activities. The sale of common stock and warrants
generated net proceeds of $13,847,000 after issuance costs, offset by the
payment of $196,000 in dividends on the Series A cumulative convertible
preferred stock.
We
believe that our available cash and equivalents will be sufficient to meet
our
working capital requirements, including operating losses, and capital
expenditure requirements into the third quarter of 2007,
assuming that our business plan is implemented successfully.
We
believe that we will need to raise additional capital during 2007 in order
to
support the pivotal Phase 3 clinical trial for NOV-002 and other research and
development activities. Furthermore, we may license or acquire other compounds
that will require capital for development. We may seek additional funding
through collaborative arrangements and public or private financings. Additional
funding may not be available to us on acceptable terms or at all. In
addition, the terms of any financing may adversely affect the holdings or the
rights of our stockholders. For example, if we raise additional funds by issuing
equity securities, further dilution to our existing stockholders may result.
If
we are unable to obtain funding on a timely basis, we may be required to
significantly curtail one or more of our research or development programs.
We
also could be required to seek funds through arrangements with collaborators
or
others that may require us to relinquish rights to some of our technologies,
product candidates, or products which we would otherwise pursue on our own.
22
Even
if
we are able to raise additional funds in a timely manner, our future capital
requirements may vary from what we expect and will depend on many factors,
including the following:
| · |
the
resources required to successfully complete our clinical trials;
|
| · |
the
time and costs involved in obtaining regulatory approvals;
|
| · |
continued
progress in our research and development programs, as well as the
magnitude of these programs;
|
| · |
the
cost of manufacturing activities;
|
| · |
the
costs involved in preparing, filing, prosecuting, maintaining, and
enforcing patent claims;
|
| · |
the
timing, receipt, and amount of milestone and other payments, if any,
from
collaborators; and
|
| · |
fluctuations
in foreign exchange rates.
|
Recently
Issued Accounting Pronouncements
In
September 2006, the Financial Accounting Standards Board (“FASB”) issued SFAS
No. 157, Fair
Value Measurements (“SFAS
157”), to define fair value, establish a framework for measuring fair value in
generally accepted accounting principles and expand disclosures about fair-value
measurements. SFAS 157 is effective for financial statements issued for fiscal
years beginning after November 15, 2007 and interim periods within those fiscal
years, with earlier application allowed. We are currently evaluating the effect
of this standard on its future reported financial position and results of
operations.
In
February 2006, the FASB issued SFAS No. 155, Accounting
for Certain Hybrid Financial Instruments—an
amendment of FASB Statements No. 133 and 140 (“SFAS
155”), to simplify and make more consistent the accounting for certain financial
instruments. SFAS 155 amends SFAS No. 133, Accounting
for Derivative Instruments and Hedging Activities,
to
permit fair-value remeasurement for any hybrid financial instrument with an
embedded derivative that otherwise would require bifurcation, provided that
the
whole instrument is accounted for on a fair-value basis. SFAS 155 amends SFAS
No. 140, Accounting
for the Impairment or Disposal of Long-Lived Assets,
to
allow a qualifying special-purpose entity to hold a derivative financial
instrument that pertains to a beneficial interest other than another derivative
financial instrument. SFAS 155 applies to all financial instruments acquired
or
issued after the beginning of an entity's first fiscal year that begins after
September 15, 2006, with earlier application allowed. This standard is not
expected to have a significant effect on our future reported financial position
or results of operations.
BUSINESS
We
were
incorporated in June 1996 as AVAM International, Inc. In October 1998, Novelos
Therapeutics, Inc., a newly incorporated entity, merged into AVAM, and the
name
of AVAM was changed to Novelos Therapeutics, Inc. In June 2005, we merged with
Common Horizons, Inc., a Nevada corporation. Following the merger, Common
Horizons, Inc. changed its state of incorporation, by-laws, certificate of
incorporation and fiscal year to that of Novelos and the surviving company
was
Novelos Therapeutics, Inc.
We
are a
biotechnology company commercializing oxidized glutathione-based compounds
for
the treatment of cancer and hepatitis. NOV-002, our lead compound, is currently
in Phase 3 development for lung cancer under a Special Protocol Assessment
and
Fast Track. NOV-002 is also in Phase 2 development for chemotherapy-resistant
ovarian cancer and early-stage breast cancer, and is also being developed for
acute radiation injury. NOV-205, our second compound, is in Phase 1b development
for chronic hepatitis C non-responders. Both compounds have completed clinical
trials in humans and have been approved for use in Russia where they were
originally developed.
23
NOV-002,
our lead compound acts as a chemoprotectant and an immunomodulator. It is
marketed in Russia by ZAO BAM under the trade name Glutoxim®, and has been
administered to over 5,000 patients, demonstrating clinical efficacy and
excellent safety. The U.S.-based Phase 1/2 clinical trial of NOV-002 for
non-small cell lung cancer (NSCLC) has been completed and the treated group
demonstrated improved objective tumor response (defined as greater than 50%
tumor shrinkage) and higher tolerance of chemotherapy versus the control group.
During an End-of-Phase 2 meeting (December 2005), the FDA agreed with us that
advancing NOV-002 into a pivotal Phase 3 trial in advanced NSCLC, in combination
with first-line chemotherapy, is warranted. In May 2006, we finalized a Special
Protocol Assessment with the FDA for a single Phase 3 pivotal trial and obtained
Fast Track designation in August 2006. The primary endpoint of this trial is
overall survival, and we commenced patient enrollment in November 2006. In
a
1996-98 Russian NSLC trial, NOV-002 increased the one-year survival rate from
17% to 63% when used in combination with chemotherapy. This result represents
an
80% improvement over the U.S. survival rate of 35% that results from the current
standard of care.
NOV-002
is also being developed to treat chemotherapy-resistant ovarian cancer. A U.S.
Phase 2 trial is ongoing at Massachusetts General Hospital and Dana-Farber
Cancer Institute. In a 1998 Russian review of case studies, NOV-002 sensitized
previously platinum-resistant ovarian cancer patients to chemotherapy. In
combination with NOV-002, 40% of the women responded favorably (partial or
complete response) to the same chemotherapy that had failed previously.
NOV-002
is also being developed to treat early-stage breast cancer. These patients
are
often treated with chemotherapy to minimize or avoid surgical intervention.
A
planned U.S. Phase 2 trial will evaluate the ability of NOV-002 to enhance
the
effectiveness of such chemotherapy while diminishing dose-limiting side-effects.
NOV-002
is in addition being developed to treat acute radiation injury.
NOV-205,
our second compound, acts as a hepatoprotective agent with immunomodulating
and
anti-inflammatory properties. Russian clinical studies completed in 1999 in
hepatitis B and C patients showed that after treatment with NOV-205, viral
load
was undetectable in a high proportion of patients and serum biochemical markers
of liver damage were significantly decreased. Our Investigational New Drug
Application for NOV-205 as mono-therapy for chronic hepatitis C has been
accepted by the FDA, and a U.S. Phase 1b trial in patients who previously failed
treatment with pegylated interferon plus ribavirin is ongoing.
Our
intellectual property portfolio includes four U.S. patents (plus a fifth notice
of allowance), two European patents and one Japanese issued
patent. Overall, we have a total of thirty patent applications filed
worldwide, with coverage including composition of matter, method of use and
manufacturing. The breadth of the intellectual property will also allow us
to
expand our pipeline by claiming and commercializing additional compounds that
are based on oxidized glutathione.
We
have
devoted substantially all of our efforts towards the research and development
of
our product candidates. As of September 30, 2006, we have incurred approximately
$9.0 million in research and development expense since our inception. We expect
to increase our expenditures
on research and development activities over the next 18 months.
Business
Strategy
Our
primary objective is to fully exploit our proprietary scientific and
intellectual property portfolio in oxidized glutathione-based therapeutics.
NOV-002, currently in Phase 3 development in the U.S., has demonstrated an
excellent safety and efficacy profile in Russia as an adjunctive treatment
to
chemotherapy for a number of different cancers. The Russian data is particularly
compelling in non-small cell lung cancer and platinum-resistant (i.e., resistant
to initial chemotherapy) ovarian cancer, and the current as well as projected
unmet medical need in these types of cancer is great. Positive results in a
controlled U.S-based Phase 1/2 lung cancer study suggest that the Russian
experience can be replicated here. Therefore, we are implementing a focused
program in each of these indications designed in hope of gaining FDA approval
in
the shortest amount of time with a reasonable amount of expense.
24
We
also
intend to explore the commercial potential of NOV-002 for treatment of acute
radiation injury in the U.S. and abroad to address the growing concern over
catastrophic radiation exposure from, for example, a nuclear weapon, a “dirty
bomb” or an accident at a nuclear power plant. Significantly, animals treated
with NOV-002 demonstrated substantially increased survival rates (two- to
three-fold, measured at thirty days post-radiation) compared to the irradiated
control animals. In addition, NOV-002 treated animals did not experience severe
neutropenia (loss of white blood cells used for fighting off infections) and
demonstrated significantly higher bone marrow cell counts than the control
(bone
marrow is the source of white blood cells). In
February 2006, we submitted a proposal to the Department of Health and Human
Services (“HHS”) for the use of NOV-002 to treat subjects that may develop Acute
Radiation Syndrome (“ARS”) after exposure to high levels of penetrating
radiation. In June 2006, HHS notified us that our proposal was within the
competitive range for discussion and further evaluation. In October 2006, HHS
notified us that NOV-002 was not eligible for procurement under this specific
award.
NOV-205
has demonstrated the ability to substantially decrease the viral load of
patients with either hepatitis B or C as well as to restore normal liver
function as evidenced by blood biochemical markers. In the U.S., both hepatitis
B and C are relatively large markets, but hepatitis B is reasonably well served.
Therefore, we will concentrate clinical development efforts on chronic hepatitis
C, which should represent a more direct path to regulatory approval as well
as
providing patients with an improved therapy regimen. We will seek to out-license
the hepatitis B indication in the Far East where the incidence of the disease
is
very high.
For
both
NOV-002 and NOV-205, we plan to develop the product in the U.S. to the point
where initiation of a pivotal trial is possible for strategic indications.
At
that point, we plan to out-license the drug and indication in Europe and/or
Japan and use resources from these arrangements to offset, in part, the expense
of the pivotal trials. In addition, we plan to out-license non-strategic
indications, like hepatitis B, in markets like the Far East (including China
and
India).
Technology
Overview
Glutathione
is a naturally occurring substance present in nearly all cells of the body.
The
glutathione pathway consists of oxidized glutathione, the primary component
of
NOV-002, and associated metabolic enzymes. It is considered to be the most
important cellular system for protection against the toxic effects of a variety
of cell-damaging molecules. More recently, it has become evident that in
addition to this cell protective role, a key function of the glutathione system
is to dynamically regulate cell function by reversibly altering the structure
of
proteins via a process termed glutathionylation. The resulting
activation/inhibition of protein function is analogous to the much-studied
role
of protein phosphorylation as a cellular regulatory mechanism.
Thus,
changes in the ratio of intracellular reduced and oxidized glutathione can
trigger glutathionylation, affecting cell signaling pathways that govern a
variety of critical cell functions including gene expression, cell
proliferation, growth arrest and apoptosis (programmed cell death). Importantly,
it has been shown that oxidized glutathione itself is capable of causing protein
glutathionylation leading to changes in cell signaling pathway function.
Examples of effects of oxidized glutathione on gene expression include
regulation of gene transcription factors such as NFkB and AP-1, which have
been
shown to have pivotal roles in the regulation of many genes involved in immune
and inflammatory responses, including cytokines and growth factors. Findings
with NOV-002 in animals and humans (e.g., cell protection; effects on cytokine
production and blood cell proliferation; immune system modulation) are
consistent with the hypothesis that it may act, at least in part, by such a
mechanism.
Pharmacological
manipulation of reduced and oxidized glutathione (e.g., including protein
glutathionylation) can have multiple and parallel effects on cells, with the
overall impact on cell function being dependent upon the type of cell and its
physiological state (i.e., normal or diseased). In light of this complexity,
identification of the precise molecular targets of NOV-002, which account for
its clinical effects, is the subject of ongoing study.
Products
in Development
Our
current developmental pipeline of drugs is based on oxidized glutathione, a
natural metabolite, that has shown excellent safety as well as preclinical
and
clinical efficacy in numerous cancers, hepatitis B and C, HIV, psoriasis,
tuberculosis and certain other diseases. The lead products are believed to
act
via modulation of critical regulatory molecules that mediate immune function,
tumor progression (in combination with chemotherapy), and drug
detoxification.
25
NOV-002
NOV-002
is an injectable, small-molecule derivative of a natural metabolite that is
being developed in combination with chemotherapy for treatment of lung, ovarian
and breast cancer.
NOV-002
for Non-Small Cell Lung Cancer
In
the
U.S., NOV-002 is in Phase 3 development for non-small cell lung cancer under
a
Special Protocol Assessment and Fast Track. NOV-002 is approved in Russia for
general medicinal usage as an immunostimulant in combination with chemotherapy
and antimicrobial therapy, and specifically for indications such as tuberculosis
and psoriasis. Efficacy and excellent safety have been demonstrated in trials
with 340 patients in Russia with several types of cancer including: non-small
cell lung cancer, colorectal cancer, pancreatic cancer, breast cancer and
ovarian cancer. Since the Russian Ministry of Health approval in 1998, NOV-002
has been administered to over 5,000 patients.
According
to the American Cancer Society, in 2006 about 1.4 million U.S. men and women
are
expected to be diagnosed with cancer. In 2006 over 550,000 U.S. cancer patients
are expected to die, which makes cancer the second leading cause of death in
the
U.S., exceeded only by deaths related to heart disease. Lung cancer is the
leading cause of cancer death in the U.S. It is expected that in 2006,
approximately 175,000 people will be diagnosed with lung cancer and more than
160,000 will die as a result. According to Globocan, there were 900,000 cases
of
lung cancer worldwide and 800,000 resulting deaths in 2002. According to Needham
& Company, the pharmaceutical market for treating lung cancer in the U.S.
was approximately $800 million in 2003. Non-small
cell lung cancer accounts for more than 80% of lung cancer. Only about 15%
of
non-small cell lung cancer patients are diagnosed early enough to be eligible
for surgery.
Platinum-based
chemotherapy regimens are standard first-line treatment for advanced non-small
cell lung cancer patients, since these patients are not eligible for surgery.
Carboplatin and paclitaxel are the most common combination therapy in the U.S.,
while cisplatin and gemcitabine are more common in Europe. During treatment,
patients continue to be subject to serious adverse effects. According to
December 2003 Credit Suisse First Boston and UBS reports and Phase 3 clinical
trials conducted prior to 1999, the one-year
survival rate for first-line therapy is typically only about 35%, median
survival is approximately 8.5 months and an objective response rate is about
20%. Overall, less than 5% of the patients survive five years. Docetaxel is
approved for use as second-line treatment of non-small cell lung cancer. New
regimens with existing cytotoxic drugs are expected to provide only incremental
improvements in efficacy and/or safety, but are very expensive. Newly emerged
targeted biologic therapies, such as Astra Zeneca’s IRESSA®, OSI’s TARCEVA® and
Genentech’s AVASTIN®, may offer some limited benefit for certain patients, but
overall efficacy has remained low, there are safety concerns and the costs
are
very high. Thus, there is a lack of effective treatments for non-small cell
lung
cancer, particularly for late stage patients.
NOV-002,
unlike any other marketed drug or product in development, appears to increase
toleration and efficacy of chemotherapy in that it allows the patient to safely
undergo more cycles of chemotherapy (demonstrated in both U.S. and Russian
studies), produces a clinical survival benefit (63% and 55% one-year survival
in
Russian studies versus 35% typical in the U.S.) and demonstrated better tumor
shrinkage (69% of the patients treated with NOV-002 plus chemotherapy had 50%
or
greater tumor shrinkage versus only 33% of the chemotherapy-alone-treated
patients). We expect that NOV-002 will be used in combination with first-line
chemotherapy treatments and may be complementary to second-line and recently
emerging third-line products. Furthermore, we expect that NOV-002 may be used
in
all disease stages for non-small cell lung cancer and other solid tumors.
The
Russian preclinical and clinical data set (including clinical safety and
efficacy, extensive animal toxicology studies and a comprehensive chemistry
and
manufacturing package) was accepted by the FDA as the basis of an
Investigational New Drug (IND) application, leading to a Novelos-sponsored
Phase
1/2 clinical trial in advanced non-small cell lung cancer in late 1999. The
aim
of the Phase 1/2 clinical study was to demonstrate safety, detect trends towards
efficacy, compare routes of administration and support initiation of a Phase
3
study. The FDA advised us in December 2005 that they agreed that advancing
NOV-002 into a pivotal Phase 3 study in advanced non-small cell lung cancer,
in
combination with first-line chemotherapy, is warranted. We finalized a Special
Protocol Assessment with the FDA in May 2006 for a single pivotal Phase 3 trial
in advanced NSCLC in combination with first-line chemotherapy, and obtained
Fast
Track designation in August 2006. The primary endpoint of this trial is overall
survival, and we commenced enrollment in November 2006.
26
In
the
U.S. Phase 1/2 non-small cell lung cancer clinical trial of NOV-002, 44
chemotherapy-naive late-stage lung cancer patients who had not received prior
chemotherapy were randomized to one of three groups for six months of
treatment:
| · |
Group
A: NOV-002, administered intravenously and intramuscularly, in combination
with cytotoxic chemotherapy (carboplatin +
paclitaxel).
|
| · |
Group
B: NOV-002, administered intravenously and subcutaneously, in combination
with cytotoxic chemotherapy.
|
| · |
Group
C: Cytotoxic chemotherapy alone was administered to this control
group.
|
Based
on
the study protocol, the intent-to-treat analysis of the best overall objective
tumor response (e.g., complete or partial tumor shrinkage) showed that eleven
out of sixteen (69%) NOV-002-treated patients in Group B demonstrated greater
than 50% tumor shrinkage versus only five out of fifteen (33%) in the control
group (C). Six out of thirteen (46%) patients in Group A demonstrated an
objective response. The difference between groups B and C was statistically
significant (p=0.044).
Further,
NOV-002-treated patients better tolerated cytotoxic chemotherapy as evidenced
by
their ability to receive more cycles of chemotherapy compared to the control
group (C). 100% of patients in Group B and 85% in Group A were able to complete
four cycles of chemotherapy, while only 50% of control group patients (C) were
able to do so. The differences between groups was statistically significant
(p=0.004).
In
St.
Petersburg, Russia, a multi-center, randomized, open-label study was conducted
to evaluate the safety and efficacy of NOV-002 in patients with advanced
non-small cell lung cancer. The overall results of the Russian non-small cell
lung cancer study were impressive. NOV-002, used in combination with
chemotherapy, dramatically and significantly increased the one-year survival
rate (63% treated group vs. 17% control, p<0.05). NOV-002 significantly
improved patients’ ability to conduct daily activities and quality of life,
increased tolerance to chemotherapy, improved hematologic parameters and
improved or normalized kidney/liver toxicity markers. Importantly, no
NOV-002-associated adverse effects were observed. In addition, in an independent
study in advanced non-small cell lung cancer study of similar design in Moscow,
55% of the patients treated with NOV-002 survived for one year.
NOV-002
for Chemotherapy (Platinum)-Resistant Ovarian Cancer
According
to the American Cancer Society, in 2006 approximately 20,000 U.S. women are
expected to be diagnosed with ovarian cancer and 15,000 women are expected
to
die from it. According to Needham & Company, the pharmaceutical market for
treating ovarian cancer was estimated to be $280 million in 2003. There is
a
lack of effective treatment, particularly in the case of refractory patients
(those who do not respond to chemotherapy).
First-line
chemotherapy treatment is the same in ovarian cancer as in non-small cell lung
cancer. Standard first-line treatment for ovarian cancer patients is carboplatin
and paclitaxel chemotherapy combination. Doxorubicin and topotecan alternate
as
second- and third-line chemotherapy treatments.
Refractory
ovarian cancer patients have a very poor prognosis because they are faced with
inadequate therapeutic options. According to a Lehman Brothers report dated
September 2002, response rates from second-line treatments, such as doxorubicin
and topotecan, are typically less than 12%. Once a woman’s ovarian cancer is
defined as platinum resistant, the chance of having a partial or complete
response to further platinum therapy is typically less than 10%, according
to
Berkenclit, J.Repro. Med., 2005.
27
In
Russia
in 1998, twenty ovarian cancer case studies were analyzed. All of these patients
were treated for three cycles with platinum-based chemotherapy but continued
with progressive disease according to qualitative assessments and Cancer Antigen
125. The patients were then treated with NOV-002 for three to four weeks,
followed by three more cycles of the same platinum-based chemotherapy (which
they previously failed to respond to) in conjunction with NOV-002. The observed
40% objective response rate across these case studies compares very favorably
to
current alternatives. Objective response is defined as partial (50% or greater
tumor reduction) or complete response; it does not include stabilization of
the
disease or small reductions in tumor size. An additional 40% of patients in
the
Russian analysis displayed stable disease.
In
the
U.S., a Phase 2 trial in chemotherapy-resistant ovarian cancer patients is
ongoing at Massachusetts General Hospital and Dana-Farber Cancer
Institute.
NOV-002
for Neoadjuvant Treatment of Breast Cancer
We
are
also developing NOV-002 to treat early-stage breast cancer in combination with
chemotherapy. These patients are often treated with chemotherapy to minimize
or
avoid surgical intervention. A planned U.S. Phase 2 trial will evaluate the
ability of NOV-002 to enhance the effectiveness of such chemotherapy while
diminishing dose-limiting side-effects.
NOV-002
for Treatment of Acute Radiation
Significant
market opportunity and unmet need exist for a drug that may safely treat the
effects of acute radiation injury. In today’s world, there appears to be more
concern than ever about an attack by a nuclear weapon, a “dirty bomb” or an
attack or accident at a nuclear power plant. The majority of deaths following
such an attack do not result from the explosion itself, but from bone marrow
suppression, which in turn leads to neutropenia (severe loss of white blood
cells, neutrophils, leaving the body defenseless against infections) and
depletion of platelets (key clotting factors that stop bleeding). The window
of
opportunity to treat radiation injury is short, thus the drug would need to
be
stockpiled at the local level in high risk areas, such as military bases, major
population centers and within a 10-50 mile radius of a nuclear power plant
facilities.
Current
post-radiation exposure treatment options are essentially non-existent.
Potassium iodide is the only pharmaceutical agent that has been stockpiled
in
the event of radiation exposure. However, it is effective only in reducing
the
risk of thyroid cancer, and does not protect the body from acute radiation
injury. Similarly, the FDA recently approved pentetate calcium trisodium
injection and pentetate zinc trisodium injection, which have already been in
use
for decades to treat radiation contamination caused by industrial accidents.
The
goal of treatment with these agents is to help remove the radioactive elements
from the body and reduce the risk of the development of illnesses such as cancer
that can occur years after exposure, but they do not address acute radiation
injury.
NOV-002
has been safely administered to several thousand Russian patients since the
mid-1990s and to a limited number of subjects in a U.S. Phase 1/2 lung cancer
trial. Further, NOV-002 has already demonstrated the ability to restore
hematological parameters and boost immune function in cancer patients receiving
cytotoxic chemotherapy. In Russian preclinical experiments in 2003, groups
of
mice and rats were exposed to lethal levels of ionizing radiation. The animals
treated with NOV-002 post-exposure demonstrated an increased survival of two-
to
three-fold (measured at thirty days post-exposure) compared to the irradiated
control animals. Moreover, there was a 2.5-fold increase in the number of
hematopoietic colony-forming units in the spleens of mice receiving NOV-002
after radiation compared to those receiving radiation alone. In another
experiment, two groups of rats were irradiated. The control group received
no
treatment. The treated group received daily injections of NOV-002. The
NOV-002-treated animals did not experience severe neutropenia and demonstrated
increased survival.
We
intend
to explore the commercial potential of NOV-002 for radiation protection in
the
U.S. and abroad to address the growing concern over catastrophic radiation
exposure from a nuclear weapon, a “dirty bomb”, or an attack/accident at a
nuclear power plant. Meanwhile, we are working with Shriners Hospitals to
conduct studies in animal models to confirm and expand upon the positive results
in treatment of acute radiation injury with NOV-002 demonstrated in Russian
experiments.
28
NOV-205
NOV-205
for Chronic Hepatitis C
NOV-205
is a unique, injectable, small-molecule proprietary formulation of oxidized
glutathione and inosine. We are developing NOV-205 in the U.S. for the treatment
of chronic hepatitis C.
According
to the World Health Organization, chronic hepatitis C affected 170 million
people worldwide in 2003, and up to four million people are newly infected
each
year. Chronic infection can progress to cirrhosis and end-stage liver disease.
While there are varying estimates about the size of the global market for
hepatitis C drugs, according to PharmaWeek November 2005 the U.S. market alone
was believed to be $800 million in 2004 and the current global market is
believed to be in excess of $2 billion per year, growing to $4 billion by 2007
and possibly $10 billion by 2012. In
the
U.S., according to the Centers for Disease Control and Prevention, an estimated
3.9 million persons were infected with hepatitis C, and 2.7 million persons
in
the U.S. had chronic infection in 2003. Further, hepatitis C infections account
for approximately 30,000 new infections and 8,000-10,000 deaths each year in
the
U.S.
NOV-205
was approved in Russia by the Ministry of Health in 2001 as mono-therapy for
the
treatment of hepatitis B and C. The Russian approval of NOV-205 was supported
by
a Russian New Drug Application, which included studies in hepatitis B and C
totaling 90 treated patients. An additional 88 patients were treated in previous
anecdotal studies. After relatively short treatment periods (1-2 months) the
drug was shown to eliminate the viral load in hepatitis B patients and to
decrease viral load below detection in 40-60% of hepatitis C subjects.
Importantly, these reductions were largely maintained during 1-3 months of
post-treatment follow-up. In addition, NOV-205 improved liver function as
evidenced by significant reductions in serum biochemical markers of liver
toxicity. No NOV-205-related adverse events were reported among any of the
178
patients treated in these studies.
The
therapeutic profile of NOV-205 contrasts sharply with those of currently
approved therapies in the U.S., which have limited effectiveness, are expensive
and have severe side effects, particularly in the case of chronic hepatitis
C.
For example, pegylated interferon and ribavirin combinations have limitations
of
safety and tolerability (40-65% of treated patients experience fatigue,
depression, fever, headaches, muscle pain, anemia). Furthermore, these drugs
are
effective in only a fraction of the patient population and are very expensive.
Other new products for hepatitis C, beyond variations of ribavirin and
interferon (e.g., HCV protease inhibitors), are at early stages of development
and could potentially be used in combination with NOV-205.
On
the
basis of the clinical and pre-clinical data package underlying Russian approval
of NOV-205 in combination with U.S. chemistry and manufacturing information,
Novelos filed an Investigational New Drug Application with the FDA for NOV-205
as mono-therapy in chronic hepatitis C in March 2006. The FDA accepted our
Investigational New Drug Application in April 2006, and a U.S. Phase 1b trial
in
patients who previously failed treatment with pegylated interferon plus
ribavirin commenced in September 2006.
Preclinical
Research Program
Our
preclinical research program is aimed at (a) gaining a better understanding
of
the mechanism(s) of action of our oxidized glutathione-based drug products
and
(b) adding to the Russian non-clinical data information that will be required
for ultimate FDA filing of our products. This research is being performed via
a
network of academic and commercial (i.e., contract research organizations)
laboratories.
We
are
engaged in funded research collaboration with the laboratory of Kenneth Tew,
Ph.D., D.Sc., Chairman of the Department of Cell and Molecular Pharmacology
and
Experimental Therapeutics at The Medical University of South Carolina. Dr.
Tew
is also chairman of our Scientific Advisory Board. The general objectives of
this research program are to add to the understanding of NOV-002 and NOV-205
as
drug products, particularly with respect to their molecular and cellular
mechanism(s) of action and to facilitate: (1) the design and execution of
clinical studies, (2) the interactions with the FDA and (3) the interactions
with others in the scientific community.
29
We
are
also working with Jeffrey Gelfand, M.D., senior advisor for international
medical affairs at Partners Healthcare System (Massachusetts General Hospital,
Harvard Medical School, Dana-Farber Cancer Institute, Brigham and Women’s
Hospital) and director of the Center for Integration of Medicine and Innovative
Technology. We have funded Dr. Gelfand’s new laboratory at Shriners Hospitals to
conduct studies in animal models to confirm and expand upon the positive results
in treatment of acute radiation injury with NOV-002 demonstrated in Russian
experiments.
We
also
intend to continue to collaborate, through ZAO BAM, with leading Russian
research institutions in Moscow and St. Petersburg, to enhance the basic science
of the glutathione pathway, support development of NOV-002 and NOV-205 and
develop additional products and product forms. Further, through our other
contacts in Russia, we believe we have access to products and technologies
developed by other Russian research institutions and scientists.
Manufacturing
Our
proprietary manufacturing process is well-established, simple, inexpensive
and
scalable. We have used U.S. and Canadian contract manufacturing facilities
to
support our U.S. development efforts. We do not plan to build manufacturing
capability over the next several years. Rather, we plan to continue to employ
contract manufacturers.
The
active pharmaceutical ingredient of NOV-002 is manufactured in the U.S. in
compliance with current Good Manufacturing Principles at Synthetech, Inc.
(Albany, OR) in a single, very cost effective synthetic step and then
lyophilized into a powder at Oregon Freeze Dry, Inc. (Albany, OR). It is then
filled, finished and packaged at Hyaluron (Burlington, MA) as a sterile
filtered, aseptically processed solution for intravenous, intramuscular and/or
subcutaneous use. NOV-002 Clinical Trial Material, API and vials, has
successfully completed 36-month stability studies.
Similar
to NOV-002, NOV-205’s active pharmaceutical ingredient is manufactured in
compliance with current Good Manufacturing Principles in a single, very cost
effective, synthetic step at Synthetech, Inc. and then lyophilized into a powder
at Oregon Freeze Dry, Inc. It is then filled, finished and packaged at Dalton
Pharma Services Inc. (Toronto, Canada).
Intellectual
Property
We
own
all intellectual property rights worldwide (excluding Russia and other states
of
the former Soviet Union) related to both clinical-stage compounds (i.e., NOV-002
and NOV-205) and other pre-clinical compounds based on oxidized glutathione.
We
have four issued patents in the U.S., and received a notice of allowance for
a
fifth U.S. patent in September 2006. We also have two issued patents in Europe
and one in Japan. Overall, we have filed over 30 patent applications
worldwide.
We
believe that our breadth of intellectual property will allow us to expand our
pipeline by claiming and commercializing additional compounds that are based
on
oxidized glutathione.
Employees
As
of
November 1, 2006, we have seven employees, all of whom are full-time employees.
We believe our relationships with our employees are good.
Regulation
The
manufacturing and marketing of NOV-002 and NOV-205 and our related research
and
development activities are subject to regulation for safety, efficacy and
quality by numerous governmental authorities in the United States and other
countries. We anticipate that these regulations will apply separately to each
drug and compound in our drug therapy technology. We believe that complying
with
these regulations will involve a considerable level of time, expense and
uncertainty.
30
In
the
United States, drugs are subject to rigorous federal regulation and, to a lesser
extent, state regulation. The Federal Food, Drug and Cosmetic Act and other
federal and state statutes and regulations govern, among other things, the
testing, manufacture, safety, efficacy, labeling, storage, record keeping,
approval, advertising and promotion of our drugs. Drug development and approval
within this regulatory framework is difficult to predict and will take a number
of years and involve the expenditure of substantial resources.
The
steps
required before a pharmaceutical agent may be marketed in the United States
include:
| · |
Pre-clinical
laboratory tests, in
vivo
pre-clinical studies, and formulation
studies;
|
| · |
The
submission to the FDA of an Investigational New Drug Application
for human
clinical testing, which must become effective before human clinical
trials
can commence;
|
| · |
Adequate
and well controlled human clinical trials to establish the safety
and
efficacy of the product;
|
| · |
The
submission of a New Drug Application or Biologic Drug License Application
to the FDA; and
|
| · |
FDA
approval of the New Drug Application or Biologic Drug License Application
prior to any commercial sale or shipment of the
product.
|
In
addition to obtaining FDA approval for each product, each product manufacturing
facility must be registered with and approved by the FDA. Manufacturing
facilities are subject to biennial inspections by the FDA and must comply with
the FDA’s Good Manufacturing Practices for products, drugs and
devices.
Whether
or not FDA approval has been obtained, approval of a product by regulatory
authorities in foreign countries must be obtained prior to the commencement
of
commercial sales of the drug in such countries. The requirements governing
the
conduct of clinical trials and drug approvals vary widely from country to
country, and the time required for approval may be longer or shorter than that
required for FDA approval. Although there are some procedures for unified
filings for certain European countries, in general, each country at this time
has its own procedures and requirements.
LITIGATION
We
are
not a party to any legal proceedings the outcome of which, in the opinion of
our
management, would have a material adverse effect on our business, financial
condition, or results of operations.
PROPERTIES
We
lease
our executive offices in Newton, Massachusetts. Our office consists of
approximately 2,200 square feet and is rented for approximately $5,700 per
month. This lease expires in August 2007. We believe that our present facilities
are adequate to meet our current needs. If new or additional space is required,
we believe that adequate facilities are available at competitive prices.
MANAGEMENT
Directors
and Executive Officers
Our
current directors and executive officers are:
|
Name
|
Age
|
Position
|
|
Simyon
Palmin
|
62
|
Chairman
of the Board
|
|
Harry
S. Palmin
|
36
|
President,
Chief Executive Officer, Director
|
|
George
R. Vaughn
|
52
|
Chief
Financial Officer and Chief Accounting Officer
|
|
M.
Taylor Burtis
|
55
|
Vice
President of Regulatory, Quality and Compliance
|
|
Christopher
J. Pazoles, Ph.D.
|
55
|
Vice
President of Research and Development
|
|
Michael
J. Doyle (1) (2) (3)
|
47
|
Director
|
|
Sim
Fass, Ph.D. (1) (2) (3)
|
63
|
Director
|
|
David
B. McWilliams (2) (3)
|
62
|
Director
|
|
Howard
M. Schneider (1) (3)
|
62
|
Director
|
(1)
Member of the audit committee.
(2)
Member of the compensation committee.
(3)
Member of the nominating and corporate governance committee.
31
Our
executive officers are appointed by, and serve at the discretion of, our board
of directors. Simyon Palmin is the father of Harry Palmin.
Simyon
Palmin.
Mr.
Palmin founded us in 1996. He has served as our chairman of the board and
director of Russian relations since 1996. From 1996 to February 2004, he served
as our chief executive officer. From 1984 to 1998, Mr. Palmin served as vice
president of strategic planning and vice president of new product development
of
Design Components Inc. Mr. Palmin received a B.S. in naval instrumentation
from
St. Petersburg Navy Institute, St. Petersburg, Russia and a M.A. in aviation
instrumentation from the Institute of Aviation Instrumentation, St. Petersburg,
Russia. He also completed studies for a Ph.D. in electrical engineering.
Harry
S. Palmin.
Mr.
Palmin has served as our president and a director since 1998 and our chief
executive officer since January 2005. From 1998 to September 2005, he served
as
our acting chief financial officer. From 1996 to 1998, he was a vice president
at Lehman Brothers and from 1993 to 1996, he was an associate at Morgan Stanley
& Co. Mr. Palmin earned a B.A. in economics and business, magna
cum laude,
and a
M.A. in international economics and finance from the International Business
School at Brandeis University. He has also studied at the London School of
Economics and the Copenhagen Business School.
George
R. Vaughn.
Mr.
Vaughn has served as our chief financial officer and chief accounting officer
since September 2005. Since April 2001, Mr. Vaughn has been President of Vaughn
& Associates, P.C., a professional services organization he founded in 1995
that provides interim and part-time chief financial officer, outsourced
financial management, and tax advisory services for emerging and established
businesses, including Novelos. From 1990 to 1995, Mr. Vaughn served as chief
financial officer of XRL, Inc. Mr. Vaughn is a certified public accountant
and
is a member of the American Institute of Certified Public Accountants and the
Massachusetts Society of Certified Public Accountants. He holds a B.S. in
business administration from Stonehill College.
Christopher
J. Pazoles, Ph.D.
Dr.
Pazoles has served as our vice president of research and development since
July
2005. From May 2004 to June 2005, he held a senior research and development
position at the Abbott Bioresearch Center, a division of Abbott Laboratories.
From October 2002 to January 2004, he served as chief operating officer and
head
of research and development at ALS Therapy Development Foundation. From 1994
to
October 2002, Dr. Pazoles served as vice president of research for Phytera,
Inc.
From 1981 to 1994, he served as a researcher and senior manager with Pfizer.
Dr.
Pazoles holds a Ph.D. in microbiology from the University of Notre
Dame.
M.
Taylor Burtis.
Ms.
Burtis has served as our vice president of regulatory, quality and compliance
since July 2005. From October 2004 to June 2005, she served as a senior
director of regulatory affairs at Therion Biologics.
From
November 2003 to September 2004, she served as a senior director of regulatory
affairs at Antigenics. From May 2000 to October 2003, Ms. Burtis served as
an
associate director for worldwide regulatory affairs at Wyeth BioPharma. From
1996 to April 2000, she served as a senior manager of regulatory affairs at
Genentech. From 1992 to 1996, Ms. Burtis was an FDA consumer safety officer
in
the Office of Compliance at the Center for Biologics Evaluation and Research.
From 1991 to 1992, Ms. Burtis served as a medical research manager at Boston
Veterans Administration Center. From 1987 to 1991, she served as a research
lab
manager at Children’s Hospital, from 1985 to 1987, she served as a laboratory
director at Brigham & Women’s Hospital and from 1980 to 1985, she served as
a technical specialist international liaison with the American Red Cross. Ms.
Burtis earned a B.S. in biology from Framingham State College and a M.B.A.
in
operations and strategy from Simmons College.
32
Michael
J. Doyle.
Mr.
Doyle has served as one of our directors since October 2005. Since April 2006,
he has served as chief executive officer of Advantedge Healthcare Solutions.
From January 2005 to March 2006, he served as chief executive officer of
Windward Advisors. From March 2000 to December 2004, Mr. Doyle served as
chairman and chief executive officer of Salesnet. From 1989 to 1997, he served
as chairman and chief executive officer of Standish Care/Carematrix, a company
he founded. He received a B.S. in biology from Tufts University and a M.B.A.
with a concentration in finance and health care from the University of Chicago,
where he was a Kaiser Fellow.
Sim
Fass,
Ph.D.
Dr.
Fass has served as one of our directors since February 2005. Dr. Fass served
as
chief executive officer and chairman of Savient Pharmaceuticals from 1997 to
2004, its president and chief executive officer from 1984 to 1997, and its
chief
operating officer from 1983 to 1984. From 1980 to 1983, Dr. Fass served as
vice
president and general manager of Wampole Laboratories. From 1969 to 1980, he
held a number of marketing, sales and senior management positions at Pfizer,
Inc
in both pharmaceuticals and diagnostics. He received a B.S. in biology and
chemistry from Yeshiva College and a doctoral degree in developmental
biology/biochemistry from the Massachusetts Institute of
Technology.
David
B. McWilliams.
Mr.
McWilliams has served as one of our directors since March 2004. From February
2004 to December 2004, Mr. McWilliams performed chief executive officer services
for us. Since August 2004, Mr. McWilliams has served as chief executive officer
of Opexa Therapeutics, Inc. From 1992 to March 2002, he served as president,
chief executive officer and a director of Encysive Pharmaceuticals (formerly
Texas Biotech). From 1989 to 1992, Mr. McWilliams served as president, chief
executive officer and director of Zonagen. From 1984 to 1988, he served as
president and chief executive officer of Kallestad Diagnostics. From 1980 to
1984, he served as president of Harleco Diagnostics Division. From 1972 to
1980,
he was an executive at Abbott Laboratories, rising to general manager for South
Africa. From 1969 to 1972, he was a management consultant at McKinsey & Co.
Mr. McWilliams is also a director of Fairway Medical Technologies, Houston
Technology Center and Texas Healthcare and Bioscience Institute. Mr. McWilliams
received a M.B.A. in finance from the University of Chicago and a B.A. in
chemistry, Phi
Beta Kappa,
from
Washington and Jefferson College.
Howard
M. Schneider.
Mr.
Schneider has served as one of our directors since February 2005. From January
to December 2003, he served as chief executive officer of Metrosoft, Inc.,
and
had been an advisor to such company from July to December 2002. From May 2000
to
May 2001, he served as president of Wofex Brokerage, Inc. and from 1965 to
1999,
he served as an executive at Bankers Trust Company, holding a variety of
positions in the commercial banking and investment banking businesses. Mr.
Schneider received a B.A., magna
cum laude,
in
economics from Harvard College and a M.B.A. with distinction from New York
University.
Employment
Agreements
On
January 31, 2006, we entered into an employment agreement with Harry Palmin
effective January 1, 2006, whereby he agreed to serve as our president and
chief
executive officer for an initial term of two years at an annual salary of
$225,000. He is eligible to receive an annual cash bonus at the discretion
of
the compensation committee and he is entitled to participate in our employee
fringe benefit plans or programs generally available to our senior executives.
The agreement provides that in the event that we terminate Mr. Palmin without
cause or he resigns for good reason (as defined below), we will (i) pay Mr.
Palmin his pro rata share of the average of his annual bonus paid during the
two
fiscal years preceding his termination; (ii) pay Mr. Palmin his base salary
for
11 months after the date of termination; (ii) continue to provide him benefits
for 11 months after the date of termination; and (iii) fifty percent of his
unvested stock options will vest. The agreement also contains a non-compete
provision, which prohibits Mr. Palmin from competing with us for one year after
termination of his employment with us.
‘‘Cause’’
means (i) gross neglect of duties for which employed; (ii) committing fraud,
misappropriation or embezzlement in the performance of duties as our employee;
(iii) conviction or guilty or nolo plea of a felony or misdemeanor involving
moral turpitude; or (iv) willfully engaging in conduct materially injurious
to
us or violating a covenant contained in the employment agreement.
33
‘‘Good
Reason’’ means (i) the failure of our board of directors to elect Mr. Palmin to
the offices of president and chief executive officer; (ii) the failure by our
stockholders to continue to elect Mr. Palmin to our board of directors; (iii)
our failure to pay Mr. Palmin the compensation provided for in the employment
agreement, except for across the board cuts applicable to all of our officers
on
an equal percentage basis; provided that such reduction is approved by our
board
of directors; (iv) relocation of Mr. Palmin’s principal place of employment to a
location beyond 50 miles of Newton, Massachusetts; (v) a reduction of base
salary or material reduction in other benefits or any material change by us
to
Mr. Palmin’s function, duties, authority, or responsibilities, which change
would cause Mr. Palmin’s position with us to become one of lesser
responsibility, importance, or scope; and (vi) our material breach of any of
the
other provisions of the employment agreement.
On
July
15, 2005, we entered into an employment agreement with Christopher J. Pazoles,
Ph.D., whereby he agreed to serve as our vice president of research and
development for an initial term of two years. His annual salary is $192,000
for
the first year and $195,000 for the second year. Dr. Pazoles is also entitled
to
a minimum cash bonus of $16,000 at the end of the first year and $25,000 at
the
end of the second year. Dr. Pazoles’ agreement provides that he is entitled to
participate in our employee fringe benefit plans or programs generally available
to our senior executives. The agreement further provides that in the event
that
we terminate Dr. Pazoles without cause or he resigns for good reason (as defined
below), we will (i) pay Dr. Pazoles his base salary through the remainder of
the
term of his employment agreement in monthly installments; (ii) continue to
provide him benefits for 12 months after the date of termination; and (iii)
pay,
on a prorated basis, any minimum bonus or other payments earned.
Dr.
Pazoles also entered into a nondisclosure and development agreement with us,
which prohibits him from competing with us and soliciting our employees or
customers during the term of his employment and for two years thereafter. If
we
terminate his employment without cause, this prohibition will only extend for
six months after his termination.
“Cause”
means Dr. Pazoles (i) has willfully failed, neglected, or refused to perform
his
duties under the employment agreement; (ii) has been convicted of or pled guilty
or no contest to a crime involving a felony; or (iii) has committed any act
of
dishonesty resulting in material harm to us.
“Good
Reason” means that Dr. Pazoles has resigned due to our failure to meet any of
our material obligations to him under the employment agreement.
On
March
21, 2006, our board of directors approved a 5% increase in Dr. Pazoles’ base
salary. This increase became effective on April 1, 2006.
Compensation
of Directors and Executive Officers
Director
Compensation
As
of
January 1, 2006, we pay our non-employee directors a cash fee of $4,000 per
quarter. The non-employee directors also receive a fee of $1,000 for any board
or committee meeting attended or $500 for each telephonic board or committee
meeting in which the director participated. We also pay each non-employee
director who serves as the chair of the audit committee an additional annual
fee
of $5,000 and each non-employee director who serves as the chairman of the
compensation and nominating and corporate governance committees an additional
annual fee of $3,000. We will also reimburse directors for reasonable
out-of-pocket expenses incurred in attending board and committee meetings and
undertaking certain matters on our behalf. Directors who are our employees
will
not receive separate fees for their services as directors. For the year ended
December 31, 2005, the chairman of our audit committee was paid $5,000 in fees.
No other director received a cash fee during 2005.
Non-employee
directors also receive stock option grants under our option plan. Commencing
January 1, 2006, options to purchase 5,000 shares of our common stock are
granted to each non-employee director per quarter at the closing price of our
common stock on the last day of the quarter. These options vest on a quarterly
basis over a two-year period.
34
Mr.
Schneider and Mr. Fass each received a non-qualified stock option to purchase
100,000 shares of our common stock in February 2005. Michael J. Doyle received
a
non-qualified stock option to purchase 100,000 shares of our common stock in
October 2005. All options were granted at the fair market value on the date
of
grant.
Executive
Officer Compensation
Summary
Compensation: The
following table sets forth certain information about the compensation we paid
or
accrued with respect to our chief executive officer and our most highly
compensated officers (other than our chief executive officer) who served as
executive officers during the year ended December 31, 2005 and whose annual
compensation exceeded $100,000 for the year ended December 31, 2005.
Other
annual compensation in the form of perquisites and other personal benefits
has
been omitted as the aggregate amount of those perquisites and other personal
benefits was less than $50,000 in the aggregate and constituted less than ten
percent of the executive officers’ respective total annual salary and bonus.
Summary
Compensation Table
|
Annual
Compensation
|
Long-Term
Compensation
|
|||||||||
|
Name
and Principal Position
|
Year
|
Salary
($)
|
Securities
Underlying Options
(#)
|
|||||||
|
Harry
S. Palmin
|
2005
|
$
|
148,000
|
400,000
|
||||||
|
President,
Chief Executive Officer
|
2004
|
$
|
155,000
|
(1)
|
330,000
|
|||||
|
Christopher
J. Pazoles, Ph.D.
|
2005
|
$
|
118,500
|
(2) |
200,000
|
|||||
|
Vice
President of Research and Development
|
2004
|
$ |
26,000
|
16,667
|
||||||
(1) Mr.
H.
Palmin earned $155,000; but he forgave $119,167 of this salary.
(2) On
March
21, 2006, our board of directors approved a 5% increase in Dr. Pazoles’ base
salary. This increase became effective on April 1, 2006.
Option
grants in last fiscal year.
The
following table sets forth certain information about stock options granted
during the year ended December 31, 2005 by us to the executive officers named
in
the summary compensation table.
Option
grants in last fiscal year
|
Individual
Grants
|
|||||||||||||
|
Name
|
Number
of securities underlying
options
granted
|
%
of total options granted to employees in fiscal
year
|
Exercise
or base price ($/share)
|
Expiration
date
|
|||||||||
|
Harry
S. Palmin
|
250,000
|
(1)
|
14
|
%
|
$
|
0.01
|
1/31/2015
|
||||||
|
150,000
|
(1)
|
8
|
%
|
$ |
0.01
|
3/31/2015
|
|||||||
|
Christopher
J. Pazoles, Ph.D.
|
200,000
|
(2)
|
11
|
%
|
$
|
0.01
|
4/08/2015
|
||||||
|
(1)
|
These
shares initially vested over a two-year period. Pursuant to their
terms,
the shares fully vested upon the completion of a non-bridge loan
financing, which occurred in the second quarter of
2005.
|
|
(2)
|
These
shares vest 25% each six-month period over two years from date of
grant.
|
35
Fiscal
year-end option table.
The
following table sets forth certain information regarding stock options held
as
of December 31, 2005 by the executive officers named in the summary compensation
table.
The
value
of unexercised in-the-money options is based on a price of $2.00 per share,
the
fair market value of our stock on December 30, 2005, minus the per-share
exercise price, multiplied by the number of shares underlying the option. Actual
gains, if any, will depend on the value of the common stock on the date of
the
sale of the shares.
Aggregated
option exercises in last fiscal year and fiscal year-end option
values
|
|
|
|
|
Number
of securities underlying
options
at fiscal year-end
|
|
Value
of in-the-money options at fiscal year-end
|
|
||||||||||||
|
Name
|
|
Shares
acquired on exercise (#)
|
|
Value
realized ($)
|
|
Exercisable
(#)
|
|
Unexercisable
(#)
|
|
Exercisable
($)
|
|
Unexercisable
($)
|
|||||||
|
Harry
S. Palmin
|
—
|
—
|
734,752
|
2,378
|
$
|
1,458,878
|
$
|
3,091
|
|||||||||||
|
Christopher
J. Pazoles, Ph.D.
|
—
|
—
|
66,667
|
150,000
|
132,667
|
298,500
|
|||||||||||||
Equity
compensation plans
The
following table provides information as of December 31, 2005 regarding shares
authorized for issuance under our equity compensation plans, including
individual compensation arrangements.
The
equity compensation plan approved by our stockholders is our 2000 stock option
and incentive plan. We issued options to our directors and consultants that
were
not approved by our stockholders. These options are exercisable within a
ten-year period from the date of the grant and vest at various intervals with
all options being fully vested within three years of the date of grant. The
option price per share is not less than the fair market value of our common
stock on the date of grant.
Equity
compensation plan information
|
Plan
category
|
Number
of shares to be issued upon exercise of outstanding options, warrants
and
rights
|
Weighted-average
exercise price of outstanding options, warrants and rights
|
Number
of shares remaining available for future issuance under equity
compensation plans (excluding shares reflected in column (a))
|
|||||||
|
(a)
|
(b)
|
(c)
|
||||||||
|
Equity
compensation plans approved by stockholders
|
73,873
|
$
|
3.16
|
0
|
||||||
|
Equity
compensation plans not approved by stockholders
|
2,653,778
|
$
|
0.53
|
0
|
||||||
|
Total
|
2,727,651
|
$
|
0.60
|
0
|
||||||
On
May 1,
2006, our board of directors adopted and on July 21, 2006 our stockholders
approved, the 2006 Stock Incentive Plan (the “2006 Plan”). A total of 5,000,000
shares of common stock are reserved for issuance under the 2006 Plan for grants
of incentive or nonqualified stock options, rights to purchase restricted and
unrestricted shares of common stock, stock appreciation rights and performance
share grants. A committee of the board of directors determines exercise prices,
vesting periods and any performance requirements on the date of grant, subject
to the provisions of the 2006 Plan. Options are granted at or above the fair
market value of the common stock at the grant date and expire on the tenth
anniversary of the grant date. In the nine months ended September 30, 2006,
stock options for the purchase of 210,000 shares of common stock were granted
under the 2006 Plan.
36
SECURITY
OWNERSHIP OF CERTAIN
BENEFICIAL
OWNERS AND MANAGEMENT
At
the
close of business on November 1, 2006, there were issued and outstanding
39,235,272 shares of our common stock. The following table provides information
regarding beneficial ownership of our common stock as of November 1, 2006
by:
| · |
Each
person known by us to be the beneficial owner of more than five percent
of
our common stock;
|
| · |
Each
of our directors;
|
| · |
Each
executive officer named in the summary compensation table; and
|
| · |
All
of our current directors and executive officers as a
group.
|
The
address of each executive officer and director is c/o Novelos Therapeutics,
Inc., One Gateway Center, Suite 504, Newton, Massachusetts 02458. The persons
named in this table have sole voting and investment power with respect to the
shares listed, except as otherwise indicated. The inclusion of shares listed
as
beneficially owned does not constitute an admission of beneficial ownership.
Shares included in the “Right to acquire” column consist of shares that may be
purchased through the exercise of options and warrants that vest within 60
days
of November 1, 2006.
|
Name
and Address of Beneficial Owner
|
Shares
Beneficially Owned
|
||||||||||||
|
|
Outstanding
|
Right
to Acquire
|
Total
|
Percentage
|
|||||||||
|
Margie
Chassman
445
West 23rd
Street, Apt. 16E
New
York, NY 10011
|
4,370,061
|
66,666
|
4,436,727
|
11.3
|
%
|
||||||||
|
Wood
River Trust
c/o
Michael C. Doyle, co-trustee
Stewart
Management Company
1410
Nemours Building
1007
Orange Street
Wilmington,
DE 19801
|
3,850,000
|
0
|
3,850,000
|
9.8
|
%
|
||||||||
|
Harry
S. Palmin
|
265,118
|
737,130
|
1,002,248
|
2.5
|
%
|
||||||||
|
Simyon
Palmin
|
1,738,939
|
487,826
|
2,226,765
|
5.6
|
%
|
||||||||
|
Christopher
J. Pazoles, Ph.D.
|
0
|
166,667
|
166,667
|
*
|
|||||||||
|
Michael
J. Doyle
|
0
|
53,750
|
53,750
|
*
|
|||||||||
|
David
McWilliams
|
0
|
156,528
|
156,528
|
*
|
|||||||||
|
Sim
Fass
|
0
|
103,750
|
103,750
|
*
|
|||||||||
|
Howard
Schneider
|
0
|
103,750
|
103,750
|
*
|
|||||||||
|
All
directors and officers as a group (9 persons)
|
2,004,057
|
1,959,401
|
3,963,458
|
9.6
|
%
|
||||||||
* Less
than
one percent.
37
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
In
connection with our private placements of units on May 27, 2005, June 29, 2005,
July 29, 2005 and August 9, 2005, we paid Margie Chassman, one of the beneficial
owners of in excess of 5% of our common stock, an aggregate of $52,000 as
finder’s fees.
In
connection with our private placement of Series A preferred stock and common
stock purchase warrants on September 30, 2005 and October 3, 2005, Ms. Chassman
provided a financial enhancement to the investors in the form of an escrow
of
2,133,000 share of her common stock, to be drawn upon by the investors if their
investment in our equity securities fails to provide a specified yield. We
paid
Ms. Chassman and her brother $166,000 for providing such financial
enhancement.
In
May
2005, we issued The Oxford Group 2,016,894 shares of our common stock in
exchange for its forgiveness of our obligation to pay The Oxford Group an amount
not to exceed $20 million, limited to 10% of our earnings before interest and
taxes. This obligation resulted from the assignment of the exclusive
intellectual property and marketing rights to the oxidized glutathione drug
development platform technology, worldwide, excluding Russia and other countries
comprising the former Soviet Union in 2000. The
shares were issued to Simyon Palmin, the Chairman of our Board of Directors,
Mark Balazovsky, a former director, and to another one of our shareholders.
Simyon Palmin is the president of The Oxford Group.
We
are
obligated to pay The Oxford Group a royalty of 0.8% of our revenue derived
from
our oxidized glutathione products during the patent life of the products. All
or
a portion of these payments may be distributed to Simyon Palmin, the Chairman
of
our Board of Directors, and Mark Balazovsky, a former director.
In
August
2000, Simyon Palmin loaned us $271,890 and Harry Palmin loaned us $250,041.
In
May 2005, Simyon Palmin forgave this loan plus accrued interest of $79,618
and
Harry Palmin forgave this loan plus accrued interest of $74,505.
From
October 1996 to October 1998, Simyon Palmin loaned us $99,000. In May 2005,
he
forgave the accrued interest of $24,362 related to this loan.
We
were
indebted to Simyon Palmin in the principal amount of $300,000 and Harry Palmin
in the principal amount of $100,000. In May 2005, Simyon Palmin converted this
debt into 480,000 shares of our common stock and Harry Palmin converted this
debt into 160,000 shares of our common stock. We also paid Messrs. Palmin an
aggregate of $23,976 and $11,250 in accrued interest on the debt during 2005
and
2004, respectively.
We
acquired our rights to the oxidized glutathione technology from ZAO BAM, a
company controlled by one of our former directors, Mark Balazovsky. We are
required to pay ZAO BAM a 1.2% royalty on our revenue from the oxidized
glutathione products during the patent life of the products and $2 million
for
each of our products utilizing such technology approved by the FDA 18 months
following such approval. Further, if we license any such products to third
parties, we are required to pay ZAO BAM 3% of all licensing revenue and an
additional 9% of such revenue to the extent it exceeds our developmental costs
of the licensed products. However, we are not required to make the 3% and 9%
payments if we are paying the 1.2% royalty. ZAO BAM also granted us an exclusive
right of first option and right of first refusal with respect to all future
developments, discoveries or inventions of ZAO BAM.
In
January 2005, we entered into an agreement with David Blech (the husband of
Margie Chassman), which provided that he or his designees would lend us $500,000
(inclusive of $100,000 previously advanced to us in December 2004 by Ms.
Chassman) for operating capital pending our debt restructuring and completion
of
our private placements of units, and up to an additional $500,000 on the same
terms if the private placement was delayed. Mr. Blech did not lend us any money.
The two loans, both of which were made by Ms. Chassman, totaled $500,000 and
bore interest at 6% per annum. We repaid Ms. Chassman the entire $500,000 out
of
proceeds of our private placements of units on August 9, 2005. According to
the
agreement, we also issued the following individuals the following number of
shares of our common stock:
38
|
Investor
|
Number
of Shares
of
Common Stock
|
|||
|
Margie
Chassman
|
2,475,000
|
|||
|
Wood
River Trust
|
3,850,000
|
|||
|
Esther
Blech
|
1,225,000
|
|||
|
Milton
Chassman
|
1,225,000
|
|||
|
Aaron
Eiger
|
1,225,000
|
|||
|
Mark
Germain
|
500,000
|
|||
|
Total
|
10,500,000
|
|||
Wood
River Trust is a trust formed for the benefit of Evan Blech, the son of Ms.
Chassman and Mr. Blech. The trustees of the trust are Harvey Kesner and Michael
C. Doyle (no relation to our director, Michael J. Doyle). Esther Blech is the
mother-in-law of Ms. Chassman. Milton Chassman is the brother of Ms. Chassman.
These investors have agreed not to publicly sell their shares of common stock
until November 20, 2006 and if they sell their shares in a private transaction,
the buyer must also agree not to sell their shares publicly until November
20,
2006.
In
1990,
Mr. Blech founded D. Blech & Company, which, until it ceased doing business
in September 1994, was a registered broker-dealer involved in underwriting
biotechnology issues. In May 1998, David Blech pled guilty to two counts of
criminal securities fraud, and, in September 1999, he was sentenced by the
U.S.
District Court for the Southern District of New York to five years’ probation,
which was completed in September 2004. Mr. Blech also settled administrative
charges by the Securities and Exchange Commission in December 2000 arising
out
of the collapse in 1994 of D. Blech & Co., of which Mr. Blech was president
and sole stockholder. The settlement prohibits Mr. Blech from engaging in future
violations of the federal securities laws and from association with any
broker-dealer. In addition, the District Business Conduct Committee for District
No. 10 of NASD Regulation, Inc. reached a decision, dated December 3, 1996,
in a
matter styled District Business Conduct Committee for District No. 10 v. David
Blech, regarding the alleged failure of Mr. Blech to respond to requests by
the
staff of the NASD for documents and information in connection with seven
customer complaints against various registered representatives of D. Blech
&
Co. The decision found that Mr. Blech failed to respond to such requests in
violation of NASD rules and that Mr. Blech should, therefore, be censured,
fined
$20,000 and barred from associating with any member firm in any capacity.
Furthermore, Mr. Blech was discharged in bankruptcy in the United States
Bankruptcy Court for the Southern District of New York in March 2000.
In
November and December 2004, Simyon Palmin loaned us $19,000. In April and June
2005, we repaid the principal amount and Mr. Palmin forgave the interest of
$465.
In
February 2004, we entered into a consulting agreement with David McWilliams,
one
of our directors, whereby he performed interim chief executive officer services
for us. We mutually terminated this consulting agreement in December 2004.
As
compensation for his services and for joining our board of directors, we granted
Mr. McWilliams an option to purchase 152,778 shares of our common stock in
April
2004.
During
various time periods in 2003 and 2004, payroll and associated payroll taxes
were
accrued for Simyon Palmin and Harry Palmin in the amounts of $207,518 and
$152,839, respectively. In May 2005, Messrs. Palmin forgave these
amounts.
39
SELLING
STOCKHOLDERS
34,285,449
shares are being offered under this prospectus, all of which are being
registered for sale for the account of the selling stockholders.
2005
Private Placement of Units Consisting of Common Stock and
Warrants
We
completed a private placement of units, each unit initially consisting of 20,000
shares of our common stock and a warrant to purchase 10,000 shares of our common
stock (the “units”), to the selling stockholders listed in the table below under
the heading “Investors in 2005 Private Placement of Units” on May 27, 2005, June
29, 2005, July 29, 2005 and August 9, 2005. In this private placement, we sold
an aggregate of 200 units. Holders of our convertible debt in the amount of
$550,000 converted debt into 22 of the 200 units. The registration statement,
of
which this prospectus is a part, was filed pursuant to the terms of our
registration rights agreements with these investors.
The
selling stockholders listed in the table below under the heading “Investors in
2005 Private Placement of Units” are offering up to 7,296,609 shares of our
common stock being registered for resale by this registration statement, of
which this prospectus is a part, consisting of:
| · |
3,980,000
shares of our outstanding common stock obtained in the private placement
transactions; and
|
| · |
3,316,609
shares of our common stock to be obtained upon exercise of three-year
common stock purchase warrants with a current exercise price of $1.35
per
share that were issued in the private placement
transactions.
|
The
selling stockholders listed in the table below under the heading “Placement
Agent and Finders Warrants and Shares issued in connection with 2005 Private
Placements of Units” are offering up to 628,692 shares of our common stock being
registered for resale by this registration statement, of which this prospectus
is a part, consisting of:
| · |
180,736
shares of our common stock to be obtained upon exercise of five-year
common stock purchase warrants with a current exercise price of $1.35
per
share that were issued as finders’ compensation in connection with the
private placement transactions;
|
| · |
125,000
shares of our common stock that were issued to vFinance Investments,
Inc.
and Mercer Capital, Ltd. as partial compensation for their services
as
placement agents; and
|
| · |
322,956
shares of our common stock to be obtained upon exercise of five-year
common stock purchase warrants with a current exercise price of $1.35
per
share that were issued to vFinance Investments, Inc. and Mercer Capital,
Ltd. as partial compensation for their services as placement
agents.
|
We
received gross proceeds of $4,450,000 and net cash proceeds of $3,715,000 (after
deducting finders’ fees and transaction costs) from this private placement.
In
connection with our private placement completed on
March 7, 2006, there was an anti-dilution adjustment to the warrants described
above. Such adjustment reduced the exercise price of the warrants to $1.35
and
increased the number of five and three year warrants to 3,333,275 and 503,692
respectively.
2005
Private
Placement of Series A Preferred Stock and Warrants
We
completed a private placement of Series A preferred stock and common stock
purchase warrants to the selling stockholders listed in the table below under
the heading “Investors in 2005 Private Placement of Series A Preferred Stock” on
September 30, 2005 and October 3, 2005. In this private placement, we sold
an
aggregate of 3,200 shares of our Series A preferred stock and warrants to
purchase 969,696 shares of our common stock. The registration statement, of
which this prospectus is a part, was filed pursuant to the terms of our
subscription agreement with these investors.
40
The
selling stockholders listed in the table below under the heading “Investors in
2005 Private Placement of Series A Preferred Stock” are offering up to 3,665,979
shares of our common stock being registered for resale by this registration
statement, of which this prospectus is a part, consisting of:
| · |
2,696,283
shares of our common stock to be obtained upon conversion of the
Series A
preferred stock in the private placement;
and
|
| · |
969,696
shares of our common stock to be obtained upon exercise of five-year
common stock purchase warrants with an exercise price of $1.35 per
share
that were issued in the private
placement.
|
We
received gross proceeds of $3,200,000 and net proceeds of $2,864,000 (after
deducting fees and transaction costs) from this private placement.
We
agreed
to register for resale additional shares of common stock in excess of the
1,939,393 shares that are issuable to certain stockholders upon conversion
of
the Series A preferred stock to accommodate possible adjustments in the
conversion rate contemplated by certain provisions of the preferred
stock.
In
connection with our private placement completed on March 7, 2006, there was
an
anti-dilution adjustment to the exercise price of our outstanding common stock
purchase warrants described above. Such adjustment reduced the exercise price
of
such warrants from $1.65 to $1.35 per share of common stock. This private
placement also resulted in an anti-dilution adjustment to the conversion price
of our Series A preferred stock from $1.65 to $1.35.
2006
Private Placement
We
completed a private placement to the selling stockholders listed in the table
below under the heading “Investors in 2006 Private Placement” on March 7, 2006.
We are filing the registration statement, of which this prospectus is a part,
pursuant to the terms of our registration rights agreements with these
investors.
The
selling stockholders listed in the table below under the heading “Investors in
2006 Private Placement” are offering up to 18,643,762 shares of our common stock
being registered for resale by this registration statement, of which this
prospectus is a part, consisting of:
| · |
8,186,845
shares of our outstanding common stock obtained in the private placement
transaction; and
|
| · |
10,456,917
shares of our common stock to be obtained upon exercise of five-year
common stock purchase warrants with an exercise price of $2.50 per
share
that were issued in the private placement
transaction.
|
The
selling stockholders listed in the table below under the heading “Placement
Agent Warrants issued in connection with 2006 Private Placement” are offering up
to 836,555 shares of our common stock to be obtained upon exercise of five-year
common stock purchase warrants with an exercise price of $2.50 per share that
were obtained as partial compensation for their services as placement
agents.
We
received gross proceeds of $15,058,005 and net proceeds of approximately
$13,900,000 (after deducting placement agent fees and transaction costs) from
this private placement.
41
Registration
Rights
2005
Private Placement of Units Consisting of Common Stock and Warrants and 2005
Private Placement of Series A Preferred Stock and
Warrants
We
entered into agreements with investors in our private placement of units
completed on May 27, 2005, June 29, 2005, July 29, 2005 and August 9, 2005
and
our private placement of Series A preferred stock on September 30, 2005 and
October 3, 2005. Pursuant to these agreements, we agreed to file with the SEC
a
registration statement covering the resale of all our common stock covered
by
this prospectus pursuant to Rule 415 of the Securities Act. The registration
rights agreements executed in connection with our private placement of units
required us to file such registration statement on or before October 8, 2005.
We
filed a registration statement on Form SB-2, of which this prospectus forms
a
part, on November 16, 2005, with respect to the resale of these shares from
time
to time. We recorded an accrued liability of $8,000 as of September 30, 2006
for
payments in connection with this late filing. The subscription agreements
executed in connection with our private placement of Series A preferred stock
required us to file such registration statement on or before November 16, 2005.
Pursuant
to the terms of the registration rights agreements executed in connection with
the private placement of units completed on May 27, 2005, June 29, 2005, July
29, 2005 and August 9, 2005, we agreed to cause the registration statement
to be
declared effective on or before February 5, 2006. The registration statement
was
declared effective on December 15, 2005. We also agreed to use our best efforts
to keep the registration statement effective for two years following its
effective date, unless the shares of our common stock covered by this prospectus
have been sold or may be sold pursuant to Rule 144(k) of the Securities Act,
subject to certain restrictions.
Pursuant
to the terms of the subscription agreements executed in connection with the
private placement of Series A preferred stock completed on September 30, 2005
and October 3, 2005, we agreed to cause the registration to be declared
effective on or before January 28, 2006 and January 31, 2006, respectively.
The
registration statement was declared effective on December 15, 2005. We also
agreed to use our best efforts keep the registration statement effective for
two
years following its effective date.
We
were
required to register for resale the shares of common stock issuable upon
conversion of the Series A preferred stock we issued in the private placement
transaction completed on September 30, 2005 and October 3, 2005 to cover the
shares of our common stock, if any, issuable as a result of adjustments
contemplated by certain provisions of the subscription agreements dated
September 30, 2005 and October 3, 2005. We are required to amend this
registration statement or file an additional registration statement, of which
this prospectus is a part, at any time if the remaining number of shares of
common stock issuable upon conversion of the Series A preferred stock or
exercise of the common stock purchase warrants exceeds 100% of the number of
shares of common stock registered by this registration statement, of which
this
prospectus is a part.
2006
Private Placement
We
entered into agreements with investors in our private placement completed on
March 7, 2006. Pursuant to these agreements, we agreed to file with the SEC
a
registration statement covering the resale of all our common stock covered
by
this prospectus pursuant to Rule 415 of the Securities Act. The subscription
agreements executed in connection with our private placement required us to
use
our best efforts to file such registration statement by the later of (i) 30
days
after the closing (April 6, 2006) or (ii) five (5) business days after we file
our Form 10-KSB for the year ended December 31, 2005 with the SEC (but no later
than March 31, 2006).
Accordingly,
we filed a registration statement on Form SB-2, of which this prospectus forms
a
part, on April 6, 2006, with respect to the resale of these shares from time
to
time. Pursuant to the terms of the subscription agreements executed in
connection with the private placement completed on March 7, 2006, we agreed
to
use our best efforts to cause the registration statement to be declared
effective on or before July 5, 2006. The registration statement was declared
effective on April 19, 2006. We also agreed to use our best efforts keep the
registration statement effective until the earliest of (i) the second
anniversary of the closing (March 7, 2008) or (ii) the date when all of the
common stock covered by the registration statement have been sold.
42
On
October 24, 2006, we advised the selling stockholders named in the registration
statements related to the resale of securities purchased in the private
placement transactions described above, that the use of the prospectuses had
been suspended due to the need to restate our financial statements for the
quarter ended September 30, 2005 and the year ended December 31, 2005. Pursuant
to the registration rights associated with these financings, we may become
obligated to the selling stockholders in the event that the suspension of the
use of the prospectuses exceeds the grace periods specified. The amount of
such
obligation, if any, will be determined during the fourth quarter of
2006.
Additional
Selling Stockholders
The
selling stockholders listed under the heading “Additional Selling Stockholders”
are offering up to 3,213,852 shares of our common stock being registered for
resale by this registration statement, of which this prospectus is a part,
consisting of:
| · |
720,000
shares of our common stock issuable upon exercise of five-year common
stock purchase warrants, with an exercise price of $0.625 per share,
issued in connection with our bridge financing in April
2005;
|
| · |
1,760,000
shares of our common stock issued to our former holders of secured
promissory notes issued in November 2003 and May 2004 in the aggregate
principal amount of $1,100,000, which were converted into equity
in May
2005 pursuant to restructuring
agreements;
|
| · |
163,952
shares of our common stock issued to our former holders of unsecured
promissory notes in the aggregate principal amount of $177,000, which
were
converted into equity in May 2005 pursuant to restructuring agreements;
|
| · |
422,400
shares of our common stock issued to three firms, as partial compensation,
for consulting services rendered to us pursuant to restructuring
agreements dated May 2005; and
|
| · |
147,500
shares of our common stock issued to current and former investor
relations
firms, as partial compensation, pursuant to consulting agreements
for
services rendered to us.
|
Selling
Stockholders Table
Based
on
the information supplied to us by each selling stockholder, the following table
sets forth the approximate number of shares beneficially owned as of November
1,
2006, by each of the selling stockholders and their pledgees, assignees and
successors in interest. The “Right to Acquire” column reflects beneficial
ownership of shares subject to warrants that may be exercised within 60 days
after November 1, 2006. The “Shares Offered” column reflects all of the shares
that each selling stockholder may offer under this prospectus. Percentage
ownership is based on 39,235,272 shares issued and outstanding as of November
1,
2006. The table assumes that the selling stockholders sell all of the
shares.
We
prepared the table below based on information supplied to us by the selling
stockholders. Although we have assumed for purposes of the table that the
selling stockholders will sell all of the shares offered by this prospectus,
because the selling stockholders may offer from time to time all or some of
their shares covered under this prospectus, or in another permitted manner,
no
assurances can be given as to the actual number of shares that will be resold
by
the selling stockholders or that will be held by the selling stockholders after
completion of the resales.
The
terms
of the common stock purchase warrants provide that the number of shares to
be
obtained by each of the holders of warrants, upon exercise of our common stock
purchase warrants, cannot exceed the number of shares that, when combined with
all other shares of our common stock and securities owned by each of them,
would
result in any one of them owning more than 4.99% of our outstanding common
stock
at any given point in time.
In
addition, the selling stockholders may have sold, transferred or otherwise
disposed of the common stock and warrants issued in the recently completed
private placement in transactions exempt from the registration requirements
of
the Securities Act since the date the selling stockholders provided the
information regarding their securities holdings.
43
Information
concerning the selling stockholders may change from time to time and changed
information will be presented in a supplement to this prospectus if and when
necessary and required. Except as described above, there are currently no
agreements, arrangements or understandings with respect to the resale of any
of
the shares covered by this prospectus.
Certain
of the selling stockholders are or were our executive officers. Harry Palmin
is
our president and chief executive officer and one of our directors. He also
served as our acting chief financial officer from 1998 to September 2005. Simyon
Palmin is our chairman of the board of directors and director of Russian
relations. He also served as our chief executive officer from 1996 to February
2004. Rudy Peselman served as our secretary until May 2005.
Except
as
described above and for the ownership of common stock, none of the selling
stockholders had any material relationship with us within the past three
years.
Selling
Stockholders
|
Beneficial
Ownership Prior to Offering
|
Beneficial
Ownership After Offering
|
|||||||||||||||||||||
| Name of Beneficial Owner |
Outstanding
|
Right
to Acquire
|
Total
|
Shares
Offered
|
Outstanding
|
Right
to Acquire
|
Percent
|
|||||||||||||||
|
Investors
in 2005 Private Placement of Units (8)
|
||||||||||||||||||||||
|
Anthony
Abenante
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
ALE
Industries- Albert Jacobs
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Alpha
Capital AG
|
160,000
|
453,333
|
613,333
|
(1)
|
613,333
|
0
|
0
|
*
|
||||||||||||||
|
John
Wayne Andrews
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Sergey
Babchin
|
771,229
|
33,333
|
804,562
|
(2)
|
553,333
|
251,229
|
0
|
*
|
||||||||||||||
|
John
Barnhardt
|
40,000
|
33,333
|
73,333
|
73,333
|
0
|
0
|
*
|
|||||||||||||||
|
Jerome
Belson
|
100,000
|
83,333
|
183,333
|
183,333
|
0
|
0
|
*
|
|||||||||||||||
|
Andrey
Beltov
|
795,871
|
33,333
|
829,204
|
(2)
|
553,333
|
275,871
|
0
|
*
|
||||||||||||||
|
Walter
Bernheimer
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Family
Ltd. Partnership Bernheimer
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Harvey
Blitz
|
40,000
|
33,333
|
73,333
|
73,333
|
0
|
0
|
*
|
|||||||||||||||
|
Erno
Bodek
|
160,000
|
133,333
|
293,333
|
|
293,333
|
0
|
0
|
*
|
||||||||||||||
|
Gerald
Brauser
|
300,000
|
250,000
|
550,000
|
550,000
|
0
|
0
|
*
|
|||||||||||||||
|
Richard
J. & Joan M. Brown
|
40,000
|
33,333
|
73,333
|
73,333
|
0
|
0
|
*
|
|||||||||||||||
|
Allen
O. & Jolaine Cage
|
60,000
|
50,000
|
110,000
|
110,000
|
0
|
0
|
*
|
|||||||||||||||
|
Camden
International
|
80,000
|
226,666
|
306,666
|
(1) |
306,666
|
0
|
0
|
*
|
||||||||||||||
|
Ron
Cate
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Margie
Chassman
|
4,370,061
|
66,666
|
4,436,727
|
146,666
|
4,290,061
|
0
|
10.9
|
|||||||||||||||
|
Simon
Clarke
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Leonard
Cohen
|
40,000
|
33,333
|
73,333
|
73,333
|
0
|
0
|
*
|
|||||||||||||||
|
Frank
A. & Carol A. Consolati
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
44
|
Beneficial
Ownership Prior to Offering
|
Beneficial
Ownership After Offering
|
|||||||||||||||||||||
| Name of Beneficial Owner |
Outstanding
|
Right
to Acquire
|
Total
|
Shares
Offered
|
Outstanding
|
Right
to Acquire
|
Percent
|
|||||||||||||||
|
Harold
E. & Connie L. Crowley
|
40,000
|
33,333
|
73,333
|
73,333
|
0
|
0
|
*
|
|||||||||||||||
|
Peter
D’Arienzo
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Frank
DeCarolis
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Ulrich
Eilers
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Richard
G. & Kenneth S. Etra
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Chris
Everest IRA
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Frank
Fila
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Anthony
J. Fortunato
|
27,000
|
16,666
|
43,666
|
36,666
|
7,000
|
0
|
*
|
|||||||||||||||
|
Eugene
Fridman
|
32,122
|
16,666
|
48,788
|
36,666
|
12,122
|
0
|
*
|
|||||||||||||||
|
Boris
Friedberg
|
40,000
|
33,333
|
73,333
|
73,333
|
0
|
0
|
*
|
|||||||||||||||
|
Vitaliy
Gassel
|
27,498
|
16,666
|
44,164
|
36,666
|
7,498
|
0
|
*
|
|||||||||||||||
|
Joseph
Giamanco
|
160,000
|
133,332
|
293,332
|
293,332
|
0
|
0
|
*
|
|||||||||||||||
|
A.
George- Gitter, Trust C, GST Exempt
|
160,000
|
133,333
|
293,333
|
293,333
|
0
|
0
|
*
|
|||||||||||||||
|
Dennis
Glynn
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Anna
& Max Goldfarb
|
64,694
|
50,000
|
114,694
|
110,000
|
4,694
|
0
|
*
|
|||||||||||||||
|
Klatte
Golf, L.P.
|
80,000
|
66,666
|
146,666
|
146,666
|
0
|
0
|
*
|
|||||||||||||||
|
Mark
Stephen Goodman
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Herbert
A. & Lily A. Gordon
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Lawrence
Gould
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Russell
Green (3)
|
20,000
|
26,828
|
46,828
|
(4)
|
46,828
|
0
|
0
|
*
|
||||||||||||||
|
James
D. & Karen J. Griffith
|
40,000
|
33,333
|
73,333
|
73,333
|
0
|
0
|
*
|
|||||||||||||||
|
Salvatore
Guerrera
|
40,000
|
33,333
|
73,333
|
73,333
|
0
|
0
|
*
|
|||||||||||||||
|
Stuart
Hanford
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Colin
J. & Gursharn K. Harvey
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Willie
Hines
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Jasuns
Holdings Ltd.
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Dr.
Vincent & Betty L. John
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Robert
& Margaret R. Kenwrick
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Gary
Kessler
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Michael
Koral
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Michael
Lane
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Richard
Lazarow
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Carlos
C. Lee
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Julian
Lender
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
45
|
Beneficial
Ownership Prior to Offering
|
Beneficial
Ownership After Offering
|
|||||||||||||||||||||
| Name of Beneficial Owner |
Outstanding
|
Right
to
Acquire
|
Total
|
Shares
Offered
|
Outstanding
|
Right
to Acquire
|
Percent
|
|||||||||||||||
|
Stolpe
Family Limited Partnership
|
80,000
|
66,666
|
146,666
|
146,666
|
0
|
0
|
*
|
|||||||||||||||
|
Lev
Lisser
|
95,122
|
70,740
|
165,862
|
(5)
|
130,740
|
35,122
|
0
|
*
|
||||||||||||||
|
Anna
Lisser
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Keith
and Patricia Little, FLP.
|
40,000
|
33,333
|
73,333
|
73,333
|
0
|
0
|
*
|
|||||||||||||||
|
Mark
Livshitz
|
49,154
|
16,666
|
65,820
|
36,666
|
29,154
|
0
|
*
|
|||||||||||||||
|
Longview
Fund LP
|
120,000
|
340,000
|
460,000
|
(1) |
460,000
|
0
|
0
|
*
|
||||||||||||||
|
Chris
Marley
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Bruce
R. Mathias
|
40,000
|
51,110
|
91,110
|
(6)
|
91,110
|
0
|
0
|
*
|
||||||||||||||
|
Albert
Mazler
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Ronald
J. Menello
|
120,000
|
99,999
|
219,999
|
219,999
|
0
|
0
|
*
|
|||||||||||||||
|
Robert
Mynett
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Derek
Neesam
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Dennis
A. Noyes
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Francis
G. O’Connor
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Richard
Olson
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Brian
Oregan
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Gerald
Ortsman
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Rick
Perlmutter
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Lauren
Pozefsky, Irrevocable Trust
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Andrew
Richards
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Michael
H. Rock
|
40,000
|
33,333
|
73,333
|
73,333
|
0
|
0
|
*
|
|||||||||||||||
|
Joseph
Roda
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Dr.
Daniel Rosberger
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Joseph
C. Roselle (3)
|
40,000
|
33,333
|
73,333
|
73,333
|
0
|
0
|
*
|
|||||||||||||||
|
Philip
Rushby
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Albert
L. Saphier IRA
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
SCG
Capital (3)
|
40,000
|
33,333
|
73,333
|
73,333
|
0
|
0
|
*
|
|||||||||||||||
|
Adam
Schacter (3) (7)
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Irwin
Schacter (3) (7)
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Steve
Schnipper
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Guido
Schoeb
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Duncan
Scott
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Fred
B. & John Sheats & Molis, Joint Tenants
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Isaak
Shklyarov
|
40,000
|
33,333
|
73,333
|
73,333
|
0
|
0
|
*
|
|||||||||||||||
46
|
Beneficial
Ownership Prior to Offering
|
Beneficial
Ownership After Offering
|
|||||||||||||||||||||
| Name of Beneficial Owner | Outstanding |
Right
to Acquire
|
Total
|
Shares
Offered
|
Outstanding |
Right
to Acquire
|
Percent
|
|||||||||||||||
|
David
M. Solomon
|
40,000
|
33,333
|
73,333
|
73,333
|
0
|
0
|
*
|
|||||||||||||||
|
Alvin
& Sharon Spearman
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Nick
Stock
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Ira
Stollar
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
David
Sukoff
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Sunrise
Equity Partners, L.P.
|
160,000
|
133,333
|
293,333
|
293,333
|
0
|
0
|
*
|
|||||||||||||||
|
Richard
& Janet Sygar
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Certified
Systems
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Alan
& Sheena Taylor
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Andrew
Telford
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Owen
James Truelove
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
|
Herbert
Weisberger
|
20,000
|
16,666
|
36,666
|
36,666
|
0
|
0
|
*
|
|||||||||||||||
| Placement Agent and Finders Warrants and Shares issued in connection with 2005 Private Placements of Units (8) | ||||||||||||||||||||||
|
Jeffrey
Auerbach (3)
|
31,997
|
62,398
|
94,395
|
94,395
|
0
|
0
|
*
|
|||||||||||||||
|
Vince
Calicchia (3)
|
7,935
|
17,296
|
25,231
|
25,231
|
0
|
0
|
*
|
|||||||||||||||
|
vFinance
Investments, Inc. (3) (7)
|
28,620
|
65,140
|
93,760
|
93,760
|
0
|
0
|
*
|
|||||||||||||||
|
Wunderlich
Securities, Inc. (7)
|
0
|
11,200
|
11,200
|
11,200
|
0
|
0
|
*
|
|||||||||||||||
|
Carmelo
Troccoli (3)
|
1,625
|
4,192
|
5,817
|
5,817
|
0
|
0
|
*
|
|||||||||||||||
|
Jonathan
Rich (3)
|
2,535
|
5,837
|
8,372
|
8,372
|
0
|
0
|
*
|
|||||||||||||||
|
David
Rich (3)(7)
|
0
|
1,592
|
1,592
|
1,592
|
0
|
0
|
*
|
|||||||||||||||
|
Maureen
Berry
|
0
|
2,081
|
2,081
|
2,081
|
0
|
0
|
*
|
|||||||||||||||
|
Stephen
Posner (3)
|
0
|
15,970
|
15,970
|
15,970
|
0
|
0
|
*
|
|||||||||||||||
|
Mercer
Capital Ltd. (3) (7)
|
9,000
|
42,665
|
51,665
|
51,665
|
0
|
0
|
*
|
|||||||||||||||
|
Scott
Shames (3)
|
31,996
|
62,400
|
94,396
|
94,396
|
0
|
0
|
*
|
|||||||||||||||
|
Jim
Reilly
|
0
|
11,851
|
11,851
|
11,851
|
0
|
0
|
*
|
|||||||||||||||
|
Andrey
Mazo (9)
|
9,040
|
11,012
|
20,052
|
11,012
|
9,040
|
642
|
*
|
|||||||||||||||
|
Marina
Mazo
|
0
|
4,444
|
4,444
|
4,444
|
0
|
0
|
*
|
|||||||||||||||
|
Michael
Freedman
|
0
|
100,740
|
100,740
|
100,740
|
0
|
0
|
*
|
|||||||||||||||
|
Jennifer
Fortunato
|
0
|
14,814
|
14,814
|
14,814
|
0
|
0
|
*
|
|||||||||||||||
|
JSM
Capital Holdings
|
11,292
|
22,023
|
33,315
|
33,315
|
0
|
0
|
*
|
|||||||||||||||
|
Investors
in 2005 Private Placement of Series A Preferred Stock
(10)
|
||||||||||||||||||||||
|
Longview
Fund LP
|
1,685,177
|
606,060
|
2,291,237
|
2,291,237
|
0
|
0
|
*
|
|||||||||||||||
|
Longview
International Equity Fund LP
|
294,906
|
106,060
|
400,966
|
400,966
|
0
|
0
|
*
|
|||||||||||||||
|
Longview
Equity Fund LP
|
547,682
|
196,970
|
744,652
|
744,652
|
0
|
0
|
*
|
|||||||||||||||
|
Sunrise
Equity Partners, L.P. (3)
|
168,518
|
60,606
|
229,124
|
229,124
|
0
|
0
|
*
|
|||||||||||||||
47
|
Beneficial
Ownership Prior to Offering
|
Beneficial
Ownership After Offering
|
|||||||||||||||||||||
| Name of Beneficial Owner | Outstanding |
Right
to Acquire
|
Total
|
Shares
Offered
|
Outstanding
|
Right
to
Acquire
|
Percent
|
|||||||||||||||
|
Investors
in 2006 Private Placement (11)
|
||||||||||||||||||||||
|
Joseph
Abrams
|
74,074
|
55,555
|
129,629
|
143,517
|
0
|
0
|
*
|
|||||||||||||||
|
ADAR
Investment Fund Ltd.
|
300,000
|
225,000
|
525,000
|
581,250
|
0
|
0
|
*
|
|||||||||||||||
|
AJW
Offshore Ltd.
|
87,111
|
65,333
|
152,444
|
168,777
|
0
|
0
|
*
|
|||||||||||||||
|
AJW
Partners LLC
|
17,037
|
12,777
|
29,814
|
33,008
|
0
|
0
|
*
|
|||||||||||||||
|
AJW
Qualified Partners LLC
|
41,777
|
31,332
|
73,109
|
80,942
|
0
|
0
|
*
|
|||||||||||||||
|
Alpha
Capital AG
|
229,322
|
166,666
|
395,988
|
430,554
|
7,100
|
0
|
*
|
|||||||||||||||
|
AS
Capital Partners, LLC (3)
|
50,000
|
37,500
|
87,500
|
96,875
|
0
|
0
|
*
|
|||||||||||||||
|
Atlas
Master Fund, Ltd.
|
138,192
|
103,644
|
241,836
|
267,747
|
0
|
0
|
*
|
|||||||||||||||
|
BASU
Biosciences, L.P.
|
74,074
|
55,555
|
129,629
|
143,517
|
0
|
0
|
*
|
|||||||||||||||
|
Michael
and Betsy Brauser
|
111,111
|
83,333
|
194,444
|
215,277
|
0
|
0
|
*
|
|||||||||||||||
|
Cranshire
Capital LP
|
0
|
166,666
|
166,666
|
208,332
|
0
|
0
|
*
|
|||||||||||||||
|
Crescent
International Ltd.
|
300,000
|
225,000
|
525,000
|
581,250
|
0
|
0
|
*
|
|||||||||||||||
|
Diamond
Opportunity Fund, LLC
|
121,159
|
194,444
|
315,603
|
364,214
|
0
|
0
|
*
|
|||||||||||||||
|
DKR
Soundshore Oasis Holding Fund Ltd.
|
185,185
|
138,888
|
324,073
|
358,795
|
0
|
0
|
*
|
|||||||||||||||
|
Double
U Master Fund LP
|
185,185
|
138,888
|
324,073
|
358,795
|
0
|
0
|
*
|
|||||||||||||||
|
Eagle
Rock Institutional Partners, LP
|
1,000,000
|
750,000
|
1,750,000
|
1,937,500
|
0
|
0
|
*
|
|||||||||||||||
|
Enable
Growth Partners LP (3)
|
270,371
|
202,778
|
473,149
|
523,843
|
0
|
0
|
*
|
|||||||||||||||
|
Enable
Opportunity Partners LP (3)
|
44,445
|
33,333
|
77,778
|
86,111
|
0
|
0
|
*
|
|||||||||||||||
|
Barry
Honig
|
0
|
277,777
|
277,777
|
347,221
|
0
|
0
|
*
|
|||||||||||||||
|
Hudson
Bay Fund LP (3)
|
0
|
138,888
|
138,888
|
173,610
|
0
|
0
|
*
|
|||||||||||||||
|
Icon
Capital Partners LP (3)
|
70,000
|
111,111
|
181,111
|
208,888
|
0
|
0
|
*
|
|||||||||||||||
|
Iroquois
Master Fund Ltd.
|
222,222
|
166,666
|
388,888
|
430,554
|
0
|
0
|
*
|
|||||||||||||||
|
Mellon
HBV SPV LLC (3)
|
0
|
1,111,110
|
1,111,110
|
1,388,888
|
0
|
0
|
*
|
|||||||||||||||
|
New
Millennium Capital Partners II, LLC
|
2,222
|
1,666
|
3,888
|
4,304
|
0
|
0
|
*
|
|||||||||||||||
|
NITE
Capital LP
|
100,870
|
277,777
|
378,647
|
448,091
|
0
|
0
|
*
|
|||||||||||||||
|
Panacea
Fund, LLC
|
222,224
|
166,668
|
388,892
|
430,559
|
0
|
0
|
*
|
|||||||||||||||
|
Pierce
Diversified Strategy Master Fund LLC (3)
|
55,556
|
41,667
|
97,223
|
107,639
|
0
|
0
|
*
|
|||||||||||||||
|
Radcliffe
SPC, Ltd. for and on behalf of the Class A Convertible Crossover
Segregated Portfolio
|
370,370
|
277,777
|
648,147
|
717,591
|
0
|
0
|
*
|
|||||||||||||||
|
RL
Capital Partners (3)
|
222,222
|
166,666
|
388,888
|
430,554
|
0
|
0
|
*
|
|||||||||||||||
|
SDS
Capital Group SPC, Ltd.
|
1,232,811
|
833,333
|
2,066,144
|
2,152,777
|
121,700
|
0
|
*
|
|||||||||||||||
|
SF
Capital Partners Ltd. (3)
|
1,000,000
|
750,000
|
1,750,000
|
1,937,500
|
0
|
0
|
*
|
|||||||||||||||
48
|
Beneficial
Ownership Prior to Offering
|
Beneficial
Ownership After Offering
|
|||||||||||||||||||||
| Name of Beneficial Owner | Outstanding |
Right
to Acquire
|
Total
|
Shares
Offered
|
Outstanding
|
Right
to Acquire
|
Percent
|
|||||||||||||||
|
Spectra
Capital Management, LLC (3)
|
0
|
166,666
|
166,666
|
208,332
|
0
|
0
|
*
|
|||||||||||||||
|
Sunrise
Equity Partners L.P. (3)
|
185,185
|
138,888
|
324,073
|
358,795
|
0
|
0
|
*
|
|||||||||||||||
|
TCMP3
Partners
|
100,000
|
75,000
|
175,000
|
193,750
|
0
|
0
|
*
|
|||||||||||||||
|
Visium
Balanced Fund, LP
|
350,324
|
262,743
|
613,067
|
678,752
|
0
|
0
|
*
|
|||||||||||||||
|
Visium
Balanced Offshore Fund, LTD
|
496,344
|
372,258
|
868,602
|
961,666
|
0
|
0
|
*
|
|||||||||||||||
|
Visium
Long Bias Fund, LP
|
72,984
|
54,738
|
127,722
|
141,406
|
0
|
0
|
*
|
|||||||||||||||
|
Visium
Long Bias Offshore Fund, LTD
|
272,156
|
204,117
|
476,273
|
527,302
|
0
|
0
|
*
|
|||||||||||||||
|
White
Rock Investments LLC
|
111,112
|
83,334
|
194,446
|
215,279
|
0
|
0
|
*
|
|||||||||||||||
| Placement Agent Warrants issued in connection with 2006 Private Placement (11) | ||||||||||||||||||||||
|
Oppenheimer
& Co. Inc.
|
0
|
401,547
|
401,547
|
501,934
|
0
|
0
|
*
|
|||||||||||||||
|
Rodman
& Renshaw LLC
|
0
|
267,697
|
267,697
|
334,621
|
0
|
0
|
*
|
|||||||||||||||
| Additional Selling Stockholders | ||||||||||||||||||||||
| Common Stock issued to Secured Lenders pursuant to Restructuring Agreements | ||||||||||||||||||||||
|
David
Gruber (9)
|
433,111
|
117,827
|
550,938
|
160,000
|
273,111
|
117,827
|
*
|
|||||||||||||||
|
Simyon
Palmin (9)
|
1,738,939
|
487,826
|
2,226,765
|
480,000
|
1,258,939
|
487,826
|
4.4
|
|||||||||||||||
|
Harry
Palmin (9)
|
265,118
|
737,130
|
1,002,248
|
160,000
|
105,118
|
737,130
|
2.1
|
|||||||||||||||
| Common Stock Issued to Unsecured Lenders pursuant to Restructuring Agreements | ||||||||||||||||||||||
|
Anatoly
Evelson
|
67,261
|
0
|
67,261
|
53,000
|
14,261
|
0
|
*
|
|||||||||||||||
|
Rudy
and Luba Peselman
|
177,428
|
0
|
177,428
|
79,952
|
97,476
|
0
|
*
|
|||||||||||||||
|
Alexander
Peselman
|
24,251
|
0
|
24,251
|
4,000
|
20,251
|
0
|
*
|
|||||||||||||||
|
Boris
Taitsel
|
34,131
|
0
|
34,131
|
27,000
|
7,131
|
0
|
*
|
|||||||||||||||
| Common Stock Issued to Consulting Firms pursuant to Restructuring Agreements | ||||||||||||||||||||||
|
Cato
Holding Company
|
377,114
|
0
|
377,114
|
360,000
|
17,114
|
0
|
*
|
|||||||||||||||
|
Euro
RSCG Life NRP
|
12,400
|
0
|
12,400
|
12,400
|
0
|
0
|
*
|
|||||||||||||||
|
Sanders
Morris Harris (7)
|
30,000
|
0
|
30,000
|
30,000
|
0
|
0
|
*
|
|||||||||||||||
|
Snehal
Patel
|
71,000
|
0
|
71,000
|
20,000
|
51,000
|
0
|
*
|
|||||||||||||||
|
Common
Stock Issued to Investor Relations Firms pursuant to Consulting
Agreements
|
||||||||||||||||||||||
|
TGR
|
125,000
|
0
|
125,000
|
100,000
|
25,000
|
0
|
*
|
|||||||||||||||
|
Pacific
Shores Investments, LLC
|
35,000
|
0
|
35,000
|
35,000
|
0
|
0
|
*
|
|||||||||||||||
|
CFSG1
|
2,500
|
0
|
2,500
|
2,500
|
0
|
0
|
*
|
|||||||||||||||
|
H.C.
Wainwright & Co., Inc. (7)
|
5,000
|
0
|
5,000
|
5,000
|
0
|
0
|
*
|
|||||||||||||||
|
Stephen
Lichaw (3)
|
35,000
|
0
|
35,000
|
5,000
|
30,000
|
0
|
*
|
|||||||||||||||
*
Less
than 1%
49
| (1) |
In
our bridge financing in April 2005, we issued common stock purchase
warrants to purchase an aggregate of 720,000 shares of our common
stock.
Alpha Capital AG received warrants to purchase 320,000 shares, Camden
International received warrants to purchase 160,000 shares and Longview
Fund LP received warrants to purchase 240,000
shares.
|
| (2) |
In
addition to 40,000 shares of common stock and 33,333 shares of common
stock issuable upon exercise of a warrant issued in connection with
the
sale of units, his outstanding shares of common stock include 480,000
shares issued upon conversion of a secured promissory note in May
2005.
|
| (3) |
The
selling stockholder has represented in its Selling Securityholder
Notice
and Questionnaire that he is an “affiliate” of a broker-dealer, and has
certified in such Questionnaire that he purchased his securities
in the
ordinary course of business, and that at the time of such purchase,
he had
no agreement or understandings, directly or indirectly, with any
person to
distribute the securities registered
hereunder.
|
| (4) |
Includes
10,162 shares issuable with respect to warrants paid as a finders'
fee in
connection with our private placement transactions of units.
|
| (5) |
Includes
20,740 shares issuable with respect to warrants paid as a finders'
fee in
connection with our private placement transactions of
units.
|
| (6) |
Includes
17,777 shares issuable with respect to warrants paid as a finders'
fee in
connection with our private placement transactions of
units.
|
| (7) |
The
selling securityholder has represented in its Selling Securityholder
Notice and Questionnaire that it is a
broker-dealer.
|
| (8) |
Shares
in the “Right to Acquire” column reflect anti-dilution adjustments made as
a result of our private placement of common stock completed on March
7, 2006.
|
| (9) |
Shares
in the “Right to Acquire” column include all shares issuable upon exercise
of options that may be exercised within 60 days from November 1,
2006.
|
| (10) | Shares in the "Outstanding" column include additional shares of common stock that may become issuable pursuant to anti-dilution adjustments to the conversion price of preferred stock. |
| (11) | Shares in the "Shares Offered" column include additional shares of common stock that may become issuable pursuant to certain anti-dilution adjustments of common stock purchase warrants. |
Voting
and Investment Control
The
table
below sets forth selling stockholders that are entities and the names of
individuals having voting and investment control over the securities held by
these entities. We determined beneficial ownership based upon information
supplied to us by the selling stockholders and in accordance with rules
promulgated by the Securities and Exchange Commission, and the information
is
not necessarily indicative of beneficial ownership for any other purpose.
The
inclusion of shares listed as beneficially owned does not constitute an
admission of beneficial ownership. Except
as
otherwise indicated, we believe that the persons or entities named in the
following table have voting and investment power with respect to all shares
of
common stock shown as beneficially owned by them, subject to community property
laws where applicable, and have not held any office or maintained any material
relationship, except as investor, with us, or any of our predecessors or
affiliates, over the past three years. Certain of the individuals with voting
and investment control have indicated that they exercise such control through
a
corporate or other organizational structure, which structural information has
not been included.
The
following entities have informed us that the following individuals have voting
and investment control over our securities held by them:
|
Entity
|
Voting
and Investment Control
|
||
|
Alpha
Capital AG
|
Konrad
Ackerman, Raines Posch
|
||
|
Family
Ltd. Partnership Bernheimer
|
Walter
Bernheimer II
|
||
|
Camden
International
|
Anthony
L.M. Inder Rieden
|
||
|
A.
George Gitter, Trust C, GST Exempt
|
S.
Alexei Gitter
|
||
|
Jasuns
Holdings Ltd.
|
James
Pearman
|
||
|
Stolpe
Family Limited Partnership
|
Duane
Stolpe
|
||
50
| Entity | Voting and Investment Control | ||
|
Keith
& Patricia Little, FLP
|
Keith
Little
|
||
|
Klatte
Golf, L.P.
|
Michael
Klatte
|
||
|
Longview
Fund LP
|
Peter
T. Benz
|
||
|
Longview
Intl Equity Fund LP
|
Wayne
H. Coleson
|
||
|
Longview
Equity Fund LP
|
Wayne
H. Coleson
|
||
|
Lauren
Pozefsky, Irrevocable Trust
|
Abby
L. Pozefsky
|
||
|
SCG
Capital
|
Steven
Geduld
|
||
|
Sunrise
Equity Partners, L.P.
|
Marilyn
Adler, Nathan Low and Amnon Mandelbaum
|
||
|
Certified
Systems
|
Dwyer
Williams
|
||
|
vFinance
Investments, Inc.
|
Leonard
Sokolow
|
||
|
Wunderlich
Securities, Inc.
|
Stephen
J. Bonnema
|
||
|
Mercer
Capital Ltd.
|
Len
Demers
|
||
|
JSM
Capital Holdings
|
John
S. Matthews
|
||
|
Cato
Holding Company
|
Allen
Cato
|
||
|
Euro
RSCG Life NRP
|
Edward
Ceraso
|
||
|
Sanders
Morris Harris
|
Ben
T. Morris
|
||
|
TGR
|
Lawrence
David Isen
|
||
|
Pacific
Shores Investment, LLC
|
Robert
Gleckman
|
||
|
CFSG1
|
Stanley
Wunderlich
|
||
|
ADAR
Investment Fund Ltd.
|
Abby
Flamholz and Yehuda Blinder
|
||
|
AJW
Offshore Ltd.
|
Corey
Ribotsky
|
||
|
AJW
Partners LLC
|
Corey
Ribotsky
|
||
|
AJW
Qualified Partners LLC
|
Corey
Ribotsky and Lloyd A. Groveman
|
||
|
Alpha
Capital AG
|
Konrad
Ackerman and Rainer Posch
|
||
|
AS
Capital Partners, LLC
|
Michael
Coughlan
|
||
|
Atlas
Master Fund, Ltd.
|
Dmitry
Balyasny and Jacob Gottlieb
|
||
|
BASU
Biosciences, L.P.
|
Shekhar
K. Basu
|
||
|
Cranshire
Capital LP
|
Mitchel
P. Kopin
|
||
|
Crescent
International Ltd.
|
Maxi
Brezzi and Bachir Taleb-Ibrahimi
|
||
|
Diamond
Opportunity Fund, LLC
|
David
Hokin, Rob Rubin and Richard Marks
|
||
|
DKR
Soundshore Oasis Holding Fund Ltd.
|
Seth
Fischer
|
||
|
Double
U Master Fund LP
|
Isaac
Winehouse
|
||
|
Eagle
Rock Institutional Partners, LP
|
Nader
Tavakoli
|
||
|
Enable
Growth Partners LP
|
Mitch
Levine
|
||
|
Enable
Opportunity Partners LP
|
Mitch
Levine
|
||
|
H.C.
Wainwright & Co., Inc.
|
John
Clarke
|
||
|
Hudson
Bay Fund LP
|
Yoav
Roth and John Doscas
|
||
|
Icon
Capital Partners LP
|
Adam
Cabibi
|
||
|
Iroquois
Master Fund Ltd.
|
Joshua
Silverman
|
||
|
Mellon
HBV SPV LLC
|
William
F. Harley III
|
||
|
New
Millennium Capital Partners II, LLC
|
Corey
Ribotsky
|
||
|
NITE
Capital LP
|
Keith
Goodman
|
||
|
Panacea
Fund, LLC
|
Michael
S. Resnick
|
||
|
Pierce
Diversified Strategy Master Fund LLC
|
Mitch
Levine
|
||
|
Radcliffe
SPC, Ltd. for and on behalf of the Class A Convertible Crossover
Segregated Portfolio
|
Steve
Katzuelson and Gerald Stahlecker
|
||
|
RL
Capital Partners
|
Tony
Polak and Ronald Lazar
|
||
|
SDS
Capital Group SPC, Ltd.
|
Steve
Derby
|
||
|
SF
Capital Partners Ltd.
|
Michael
A. Roth and Brian J. Stark
|
||
|
Spectra
Capital Management LLC
|
Allan
Rosenberg
|
||
|
Sunrise
Equity Partners L.P.
|
Nathan
Low, Marilyn Adler and Amnon
Mandelbaum
|
||
51
| Entity | Voting and Investment Control | ||
|
TCMP3
Partners
|
Steven
Slawson and Walter Schenker
|
||
|
Visium
Balanced Fund, LP
|
Dmitry
Balyasny and Jacob Gottlieb
|
||
|
Visium
Balanced Offshore Fund, LTD
|
Dmitry
Balyasny and Jacob Gottlieb
|
||
|
Visium
Long Bias Fund, LP
|
Dmitry
Balyasny and Jacob Gottlieb
|
||
|
Visium
Long Bias Offshore Fund, LTD
|
Dmitry
Balyasny and Jacob Gottlieb
|
||
|
White
Rock Investments LLC
|
Joseph
Giamanco
|
||
DESCRIPTION
OF SECURITIES
Under
our
amended and restated certificate of incorporation, our authorized capital stock
consists of 100,000,000 shares of common stock, $0.00001 par value per share,
and 7,000 shares of preferred stock, $0.00001 par value per share. As of
November 1, 2006, 39,235,272 shares of our common stock and 3,264 shares of
our
preferred stock were issued and outstanding. All outstanding shares of our
common stock and preferred stock are duly authorized, validly issued, fully-paid
and non-assessable.
Our
amended and restated certificate of incorporation authorizes us to issue shares
of our preferred stock from time to time in one or more series without
stockholder approval. As of November 1, 2006, we had designated 7,000 shares
as
Series A 8% cumulative convertible preferred stock, 3,264 of which were issued
and outstanding on that date.
Common
Stock
Voting.
Holders
of our common stock are entitled to one vote per share held of record on all
matters to be voted upon by our stockholders. Our common stock does not have
cumulative voting rights. Persons who hold a majority of the outstanding common
stock entitled to vote on the election of directors can elect all of the
directors who are eligible for election.
Dividends.
Subject
to preferences that may be applicable to the holders of any outstanding shares
of our preferred stock, the holders of our common stock are entitled to receive
such lawful dividends as may be declared by our board of directors.
Liquidation
and Dissolution.
In the
event of our liquidation, dissolution or winding up, and subject to the rights
of the holders of any outstanding shares of our preferred stock, the holders
of
shares of our common stock will be entitled to receive pro rata all of our
remaining assets available for distribution to our stockholders.
Other
Rights and Restrictions.
Our
charter prohibits us from granting preemptive rights to any of our stockholders.
All outstanding shares are fully paid and nonassessable.
Listing.
Our
common stock is traded on the over-the-counter bulletin board under the trading
symbol “NVLT.OB”.
Series
A 8% Cumulative Convertible Preferred Stock
Voting
Rights:
The
Series A preferred stockholders do not have voting rights. The holders of a
majority of the Series A preferred stock, as a class, have the right to nominate
one member for election to our board of directors for so long as any shares
of
our Series A preferred stock are outstanding. They nominated Michael J. Doyle
and he has been elected to our board of directors.
Dividends:
The
Series A preferred stock has a dividend rate of 8% per annum, payable quarterly,
which rate increases to 20% per annum on the second anniversary of the date
of
issuance and upon the occurrence of certain events of default specified in
the
certificate of incorporation. Such dividends may be paid in cash or in shares
of
our Series A preferred stock.
52
Conversion:
Each
share of Series A preferred stock was initially convertible at a price of $1.65
per common share and is now convertible at a price of $1.35 per common share.
The Series A preferred stock can be converted only to the extent that the Series
A stockholder will not, as a result of the conversion, hold in excess of 4.99%
of the total outstanding shares of our common stock.
Antidilution:
Upon
the occurrence of a stock split, stock dividend, combination of our common
stock
into a smaller number of shares, issuance of any of our shares or other
securities by reclassification of our common stock, merger or sale of
substantially all of our assets, the conversion rate shall be adjusted so that
the conversion rights of the Series A preferred stock stockholders will be
equivalent to the conversion rights of the Series A preferred stock stockholders
prior to such event.
Redemption:
The
Series A preferred stock is not redeemable at the option of the holder. However,
we may redeem the Series A preferred stock for $1,200 per share plus any accrued
but unpaid dividends upon 30 days’ (during which time the Series A preferred
stock may be converted) prior written notice if a registration statement has
been filed with and declared effective by the Securities and Exchange Commission
covering the shares of our common stock issuable upon conversion of the Series
A
preferred stock.
Dissolution:
In the
event of any voluntary or involuntary liquidation, dissolution or winding up
of
our affairs, the Series A preferred stock will be treated as senior to our
common stock. The Series A preferred stockholders will be entitled to receive
first, $1,000 per share and all accrued and unpaid dividends. If, upon any
winding up of our affairs, our assets available to pay the holders of Series
A
preferred stock are not sufficient to permit the payment in full, then all
our
assets will be distributed to the holders of our Series A preferred stock on
a
pro rata basis.
Anti-Takeover
Effect of Delaware Law, Certain By-Law Provisions
Provisions
of Delaware law, our charter and our by-laws could make it more difficult to
acquire us by means of a merger, tender offer, proxy contest, open market
purchases, removal of incumbent directors and otherwise. These provisions,
which
are summarized below, are expected to discourage types of coercive takeover
practices and inadequate takeover bids and to encourage persons seeking to
acquire control of us to first negotiate with us. We believe that the benefits
of increased protection of our potential ability to negotiate with the proponent
of an unfriendly or unsolicited proposal to acquire or restructure us outweigh
the disadvantages of discouraging takeover or acquisition proposals because
negotiation of these proposals could result in an improvement of their terms.
Authorized
but Unissued Stock.
We have
shares of common stock and preferred stock available for future issuance, in
some cases, without stockholder approval. We may issue these additional shares
for a variety of corporate purposes, including public offerings to raise
additional capital, corporate acquisitions, stock dividends on our capital
stock
or equity compensation plans.
The
existence of unissued and unreserved common stock and preferred stock may enable
our board of directors to issue shares to persons friendly to current management
or to issue preferred stock with terms that could render more difficult or
discourage a third-party attempt to obtain control of us, thereby protecting
the
continuity of our management. In addition, if we issue preferred stock, the
issuance could adversely affect the voting power of holders of common stock
and
the likelihood that such holders will receive dividend payments and payments
upon liquidation.
Business
Combinations.
As a
Delaware corporation, we are subject to Section 203 of the Delaware General
Corporation Law, an anti-takeover law. In general, Section 203 prohibits a
publicly held Delaware corporation from engaging in a business combination
with
an interested stockholder for a period of three years after the date the person
becomes an interested stockholder, unless the business combination or the
transaction in which the person becomes an interested stockholder is approved
in
a prescribed manner. Generally, a business combination includes a merger, asset
or stock sale, or other transaction resulting in a financial benefit to an
interested stockholder. An interested stockholder includes a person who,
together with affiliates and associates, owns, or did own within three years
before the person was determined to be an interested stockholder, 15% or more
of
a corporation’s voting stock. The existence of this provision generally will
have an anti-takeover effect for transactions not approved in advance by the
board of directors, including discouraging attempts that might result in a
premium over the market price of our common stock.
53
Vacancies
on the Board of Directors.
Our
by-laws provide that any vacancy on the board of directors, however occurring,
including a vacancy resulting from an enlargement of the board, may be filled
only by the vote of a majority of the directors then in office. This limitation
on the filling of vacancies could have the effect of making it more difficult
for a third party to acquire, or of discouraging a third party from acquiring,
control of us.
Special
Meeting of Stockholders.
Our
by-laws provide that any action required or permitted to be taken by our
stockholders at an annual meeting or special meeting of stockholders may only
be
taken if it is properly brought before the meeting.
PLANS
OF DISTRIBUTION
FOR
SELLING STOCKHOLDERS FROM THE 2006 PRIVATE PLACEMENT
We
are
registering the shares offered by this prospectus on behalf of the selling
stockholders. The selling stockholders, which as used herein includes donees,
pledgees, transferees or other successors-in-interest selling shares of common
stock or interests in shares of common stock received after the date of this
prospectus from a selling stockholder as a gift, pledge, partnership
distribution or other transfer, may, from time to time, sell, transfer or
otherwise dispose of any or all of their shares of common stock or interests
in
shares of common stock on any stock exchange, market or trading facility on
which the shares are traded or in private transactions. These dispositions
may
be at fixed prices, at prevailing market prices at the time of sale, at prices
related to the prevailing market price, at varying prices determined at the
time
of sale, or at negotiated prices. To the extent any of the selling stockholders
gift, pledge or otherwise transfer the shares offered hereby, such transferees
may offer and sell the shares from time to time under this prospectus, provided
that this prospectus has been amended under Rule 424(b)(3) or other applicable
provision of the Securities Act to include the name of such transferee in the
list of selling stockholders under this prospectus.
The
selling stockholders may use any one or more of the following methods when
disposing of shares or interests therein:
| · |
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 resale by the broker-dealer for
its
account;
|
| · |
an
exchange distribution in accordance with the rules of the applicable
exchange;
|
| · |
privately
negotiated transactions;
|
| · |
short
sales;
|
| · |
through
the writing or settlement of options or other hedging transactions,
whether through an options exchange or
otherwise;
|
| · |
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 such methods of sale;
and
|
| · |
any
other method permitted pursuant to applicable
law.
|
54
The
selling stockholders may, from time to time, pledge or grant a security interest
in some or all of the shares of common stock owned by them and, if they default
in the performance of their secured obligations, the pledgees or secured parties
may offer and sell the shares of common stock, from time to time, under this
prospectus, or under an amendment to this prospectus under Rule 424(b)(3) or
other applicable provision of the Securities Act amending the list of selling
stockholders to include the pledgee, transferee or other successors in interest
as selling stockholders under this prospectus.
In
connection with the sale of our common stock or interests therein, the selling
stockholders may enter into hedging transactions with broker-dealers or other
financial institutions, which may in turn engage in short sales of the common
stock in the course of hedging the positions they assume. The selling
stockholders may also sell shares of our common stock short and deliver these
securities to close out their short positions, or loan or pledge the common
stock to broker-dealers that in turn may sell these securities. The selling
stockholders may also enter into option or other transactions with
broker-dealers or other financial institutions or the creation of one or more
derivative securities which require the delivery to such broker-dealer or other
financial institution of shares offered by this prospectus, which shares such
broker-dealer or other financial institution may resell pursuant to this
prospectus (as supplemented or amended to reflect such
transaction).
The
aggregate proceeds to the selling stockholders from the sale of the common
stock
offered by them will be the purchase price of the common stock less discounts
or
commissions, if any. Each of the selling stockholders reserves the right to
accept and, together with their agents from time to time, to reject, in whole
or
in part, any proposed purchase of common stock to be made directly or through
agents. We will not receive any of the proceeds from this offering. Upon any
exercise of the warrants by payment of cash, however, we will receive the
exercise price of the warrants.
The
selling stockholders also may resell all or a portion of the shares in open
market transactions in reliance upon Rule 144 under the Securities Act of 1933,
provided that they meet the criteria and conform to the requirements of that
rule.
The
selling shareholders might be, and any broker-dealers that act in connection
with the sale of securities will be, deemed to be “underwriters” within the
meaning of Section 2(11) of the Securities Act, and any commissions received
by
such broker-dealers and any profit on the resale of the securities sold by
them
while acting as principals will be deemed to be underwriting discounts or
commissions under the Securities Act.
To
the
extent required, the shares of our common stock to be sold, the names of the
selling stockholders, the respective purchase prices and public offering prices,
the names of any agents, dealer or underwriter, any applicable commissions
or
discounts with respect to a particular offer will be set forth in an
accompanying prospectus supplement or, if appropriate, a post-effective
amendment to the registration statement that includes this
prospectus.
In
order
to comply with the securities laws of some states, if applicable, the common
stock may be sold in these jurisdictions only through registered or licensed
brokers or dealers. In addition, in some states the common stock may not be
sold
unless it has been registered or qualified for sale or an exemption from
registration or qualification requirements is available and is complied
with.
We
have
advised the selling stockholders that the anti-manipulation rules of Regulation
M under the Exchange Act may apply to sales of shares in the market and to
the
activities of the selling stockholders and their affiliates. In addition, we
will make copies of this prospectus (as it may be supplemented or amended from
time to time) available to the selling stockholders for the purpose of
satisfying the prospectus delivery requirements of the Securities Act. The
selling stockholders may indemnify any broker-dealer that participates in
transactions involving the sale of the shares against certain liabilities,
including liabilities arising under the Securities Act.
We
have
agreed to indemnify the selling stockholders against liabilities, including
liabilities under the Securities Act and state securities laws, relating to
the
registration of the shares offered by this prospectus. The selling stockholders
have agreed to indemnify us in certain circumstances against certain
liabilities, including liabilities under the Securities Act.
55
The
shares offered hereby were originally issued to the selling stockholders
pursuant to an exemption from the registration requirements of the Securities
Act. We have agreed with the selling stockholders to keep the registration
statement that includes this prospectus effective until the earlier of (1)
such
time as all of the shares covered by this prospectus have been disposed of
pursuant to and in accordance with the registration statement or (2) the date
on
which the shares may be sold pursuant to Rule 144(k) of the Securities Act.
We
have agreed to pay all expenses in connection with this offering, but not
including underwriting discounts, concessions, commissions or fees of the
selling stockholders or any fees and expenses of counsel or other advisors
to
the selling stockholders.
FOR
SELLING STOCKHOLDERS FROM THE 2005 PRIVATE
PLACEMENT OF UNITS AND 2005 PRIVATE PLACEMENT OF SERIES A PREFERRED STOCK AND
WARRANTS
Each
selling stockholder and any of their pledgees, assignees and
successors-in-interest may, from time to time, sell any or all of their shares
of common stock on the OTC Bulletin Board or any other stock exchange, market
or
trading facility on which the shares are traded or in private transactions.
These sales may be at fixed or negotiated prices. A selling stockholder may
use
any one or more of the following methods when selling 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 resale by the broker-dealer for
its
account;
|
| · |
an
exchange distribution in accordance with the rules of the applicable
exchange;
|
| · |
privately
negotiated transactions;
|
| · |
settlement
of short sales entered into after the date of this prospectus;
|
| · |
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 such methods of sale;
|
| · |
through
the writing or settlement of options or other hedging transactions,
whether through an options exchange or otherwise; or
|
| · |
any
other method permitted pursuant to applicable law.
|
The
selling stockholders may also sell shares under Rule 144 under the Securities
Act of 1933, as amended, if available, rather than under this
prospectus.
Broker-dealers
engaged by the selling stockholders may arrange for other brokers-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, but,
except as set forth in a supplement to this prospectus, in the case of an agency
transaction not in excess of a customary brokerage commission in compliance
with
NASD Rule 2440; and in the case of a principal transaction a markup or markdown
in compliance with NASD IM-2440.
In
connection with the sale of our common stock or interests therein, the selling
stockholders may enter into hedging transactions with broker-dealers or other
financial institutions, which may in turn engage in short sales of our common
stock in the course of hedging the positions they assume. The selling
stockholders may also sell shares of our common stock short and deliver these
securities to close out their short positions, or loan or pledge our common
stock to broker-dealers that in turn may sell these securities. The selling
stockholders may also enter into option or other transactions with
broker-dealers or other financial institutions or the creation of one or more
derivative securities which require the delivery to such broker-dealer or other
financial institution of shares offered by this prospectus, which shares such
broker-dealer or other financial institution may resell pursuant to this
prospectus (as supplemented or amended to reflect such
transaction).
56
The
selling stockholders and any broker-dealers or agents that are involved in
selling the shares may be deemed to be ‘‘underwriters’’ within the meaning of
the Securities Act in connection with such sales. In such event, any commissions
received by such broker-dealers or agents and any profit on the resale of the
shares purchased by them may be deemed to be underwriting commissions or
discounts under the Securities Act. Each selling stockholder has informed us
that it does not have any written or oral agreement or understanding, directly
or indirectly, with any person to distribute our common stock.
We
are
required to pay certain fees and expenses incurred by us incident to the
registration of the shares. We have agreed to indemnify the selling stockholders
against certain losses, claims, damages and liabilities, including liabilities
under the Securities Act.
Because
selling stockholders may be deemed to be ‘‘underwriters’’ within the meaning of
the Securities Act, they will be subject to the prospectus delivery requirements
of the Securities Act. In addition, any securities covered by this prospectus
which qualify for sale pursuant to Rule 144 under the Securities Act may be
sold
under Rule 144 rather than under this prospectus. Each selling stockholder
has
advised us that they have not entered into any written or oral agreements,
understandings or arrangements with any underwriter or broker-dealer regarding
the sale of the resale shares. There is no underwriter or coordinating broker
acting in connection with the proposed sale of the resale shares by the selling
stockholders.
We
agreed
to keep this prospectus effective until the earlier of (i) the date on which
the
shares may be resold by the selling stockholders without registration and
without regard to any volume limitations by reason of Rule 144(e) under the
Securities Act or any other rule of similar effect or (ii) all of the shares
have been sold pursuant to the prospectus or Rule 144 under the Securities
Act
or any other rule of similar effect. The resale shares will be sold only through
registered or licensed brokers or dealers if required under applicable state
securities laws. In addition, in certain states, the resale shares may not
be
sold unless they have been registered or qualified for sale in the applicable
state or an exemption from the registration or qualification requirement is
available and is complied with.
Under
applicable rules and regulations under the Exchange Act, any person engaged
in
the distribution of the resale shares may not simultaneously engage in market
making activities with respect to our common stock for a period of two business
days prior to the commencement of the distribution. In addition, the selling
stockholders will be subject to applicable provisions of the Exchange Act and
the rules and regulations thereunder, including Regulation M, which may limit
the timing of purchases and sales of shares of our common stock by the selling
stockholders or any other person. We will make copies of this prospectus
available to the selling stockholders and have informed them of the need to
deliver a copy of this prospectus to each purchaser at or prior to the time
of
the sale.
DISCLOSURE
OF COMMISSION POSITION ON
INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
Our
charter contains provisions to indemnify our directors and officers to the
maximum extent permitted by Delaware law. We believe that indemnification under
our charter covers at least negligence on the part of an indemnified person.
Our
charter permits us to advance expenses incurred by an indemnified person in
connection with the defense of any action or proceeding arising out of the
person’s status or service as our director, officer, employee or other agent
upon an undertaking by the person to repay those advances if it is ultimately
determined that the person is not entitled to indemnification.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933
may
be permitted to directors, officers and controlling persons of the small
business issuer pursuant to the foregoing provisions, or otherwise, the small
business issuer has been advised that in the opinion of the Securities and
Exchange Commission such indemnification is against public policy as expressed
in the Securities Act of 1933 and is, therefore, unenforceable.
57
WHERE
YOU CAN FIND MORE INFORMATION
We
are a
reporting company and file annual, quarterly and special reports, proxy
statements and other information with the Securities and Exchange Commission.
Copies of the reports, proxy statements and other information may be read and
copied at the SEC’s Public Reference Room at 450 Fifth Street, N.W., Washington,
D.C. 20549. You can request copies of such documents by writing to the SEC
and
paying a fee for the copying cost. You may obtain information on the operation
of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC
maintains a web site at http://www.sec.gov that contains reports, proxy and
information statements and other information regarding registrants that file
electronically with the SEC.
This
prospectus is part of a registration statement on Form SB-2 that we filed with
the SEC. Certain information in the registration statement has been omitted
from
this prospectus in accordance with the rules and regulations of the SEC. We
have
also filed exhibits and schedules with the registration statement that are
excluded from this prospectus. For further information you may:
| · |
read
a copy of the registration statement, including the exhibits and
schedules, without charge at the SEC’s Public Reference Room; or
|
| · |
obtain
a copy from the SEC upon payment of the fees prescribed by the SEC.
|
LEGAL
MATTERS
The
validity of the securities being offered by this prospectus have been passed
upon for us by Foley Hoag LLP, Boston, Massachusetts.
EXPERTS
Stowe
& Degon have audited our financial statements as of December 31, 2005 and
for the years ended December 31, 2005 and 2004. The financial statements
referred to above are included in this prospectus with reliance upon the
independent registered public accounting firm’s opinion based on its expertise
in accounting and auditing.
58
ITEM
7. FINANCIAL STATEMENTS
INDEX
TO FINANCIAL STATEMENTS
|
|
Page
|
|
|
|
|
|
|
FINANCIAL
STATEMENTS FOR NOVELOS THERAPEUTICS, INC.
|
|
F-1
|
|
|
|
|
|
Report
of Independent Registered Public Accounting Firm
|
|
F-2
|
|
|
|
|
|
Balance
Sheets at September 30, 2006 and December 31, 2005
|
|
F-3
|
|
|
|
|
|
Statements
of Operations for the Nine Months Ended September 30,
2006 and 2005 and
the Years Ended December 31, 2005 and 2004
|
|
F-4
|
|
|
|
|
|
Statements
of Stockholders’ Equity (Deficiency) for the Nine Months Ended September
30, 2006 and the Years Ended December 31, 2005 and 2004
|
|
F-5
|
|
|
|
|
|
Statements
of Cash Flows for the Nine Months Ended September 30,
2006 and 2005 and
the Years Ended December 31, 2005 and 2004
|
|
F-6
|
|
|
|
|
|
Notes
to Financial Statements
|
F-7
|
F-1
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the
Stockholders and Board of Directors
Novelos
Therapeutics, Inc.
Newton,
Massachusetts
We
have
audited the accompanying balance sheets of Novelos Therapeutics, Inc. as of
December 31, 2005 and the related statements of operations, stockholders’ equity
(deficiency) and cash flows for the years ended December 31, 2005 and December
31, 2004. These financial statements are the responsibility of the Company’s
management. Our responsibility is to express an opinion on these financial
statements based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we
plan
and perform the audits to obtain reasonable assurance about whether the
financial statements are free of material misstatement. The Company is not
required to have, nor were we engaged to perform, an audit of its internal
control over financial reporting. Our audit included consideration of internal
control over financial reporting as a basis for designing audit procedures
that
are appropriate in the circumstances, but not for the purpose of expressing
an
opinion on the effectiveness of the Company’s internal control over financial
reporting. Accordingly we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures
in
the financial statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
As
discussed in Note 13, the financial statements have been restated for changes
to
the Company’s accounting for the beneficial conversion feature associated with
its Series A 8% Cumulative Convertible Preferred Stock and to correct the
calculation of Net Loss Attributable to Common Stockholders and Basic and
Diluted Net Loss Attributable to Common Stockholders Per Common
Share.
In
our
opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of Novelos Therapeutics, Inc. as
of
December 31, 2005 and the results of its operations, changes in stockholders’
deficiency and cash flows for the years ended December 31, 2005 and December
31,
2004 in conformity with accounting principles generally accepted in the United
States.
/s/
Stowe
& Degon
Worcester,
Massachusetts
March
22,
2006 except for Notes 5 and 13 for which the date is November 1,
2006
F-2
NOVELOS
THERAPEUTICS, INC.
BALANCE
SHEETS
|
September
30,
2006
|
December
31,
2005
|
||||||
|
|
(Unaudited)
|
(Audited)
|
|||||
| ASSETS | |||||||
|
CURRENT
ASSETS:
|
|||||||
|
Cash
and equivalents
|
$
|
11,711,402
|
$
|
4,267,115
|
|||
|
Restricted
cash
|
2,210,768
|
196,908
|
|||||
|
Prepaid
expenses and other current assets
|
371,183
|
337,902
|
|||||
|
Total
current assets
|
14,293,353
|
4,801,925
|
|||||
|
FIXED
ASSETS, NET
|
26,134
|
22,610
|
|||||
|
DEFERRED
FINANCING COSTS
|
—
|
24,612
|
|||||
|
PREPAID
EXPENSES
|
—
|
79,896
|
|||||
|
DEPOSITS
|
10,875
|
9,656
|
|||||
|
TOTAL
ASSETS
|
$
|
14,330,362
|
$
|
4,938,699
|
|||
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
|
CURRENT
LIABILITIES:
|
|||||||
|
Accounts
payable and accrued liabilities
|
$
|
1,102,067
|
$
|
211,456
|
|||
|
Accrued
interest
|
5,700
|
5,700
|
|||||
|
Total
current liabilities
|
1,107,767
|
217,156
|
|||||
|
COMMITMENTS
AND CONTINGENCIES
|
|||||||
|
STOCKHOLDERS’
EQUITY:
|
|||||||
|
Preferred
Stock, $0.00001 par value;7,000 shares authorized: Series A 8% cumulative
convertible preferred stock; 3,264 shares issued and outstanding
(liquidation preference $3,264,000)
|
—
|
—
|
|||||
|
Common
stock; $0.00001 par value; 100,000,000 shares authorized; 39,235,272
and
27,921,199 shares issued and outstanding at September 30, 2006 and
December 31, 2005, respectively
|
392
|
279
|
|||||
|
Additional
paid-in capital
|
34,233,883
|
20,119,820
|
|||||
|
Accumulated
deficit
|
(21,011,680
|
)
|
(15,398,556
|
)
|
|||
|
Total
stockholders’ equity
|
13,222,595
|
4,721,543
|
|||||
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
14,330,362
|
$
|
4,938,699
|
|||
See
notes to financial statements.
F-3
NOVELOS
THERAPEUTICS, INC.
STATEMENTS
OF OPERATIONS
|
Nine
Months Ended September 30,
|
Year
Ended December 31,
|
||||||||||||
|
|
2006
|
2005
|
2005
|
2004
|
|||||||||
|
Unaudited
|
Restated
(Note
13)
Unaudited
|
Restated
(Note 13)
Audited
|
Audited
|
||||||||||
|
REVENUES:
|
|||||||||||||
|
Sales
of samples
|
$
|
—
|
$
|
12,584
|
$
|
12,584
|
$
|
4,962
|
|||||
|
Total
revenue
|
—
|
12,584
|
12,584
|
4,962
|
|||||||||
|
COSTS
AND EXPENSES:
|
|||||||||||||
|
Research
and development
|
4,200,465
|
927,169
|
1,136,217
|
261,768
|
|||||||||
|
General
and administrative
|
1,889,182
|
905,224
|
1,442,749
|
368,413
|
|||||||||
|
Total
costs and expenses
|
6,089,647
|
1,832,393
|
2,578,966
|
630,181
|
|||||||||
|
OTHER
INCOME (EXPENSE):
|
|||||||||||||
|
Consulting
revenue
|
—
|
—
|
—
|
13,374
|
|||||||||
|
Interest
income
|
472,023
|
9,693
|
49,876
|
95
|
|||||||||
|
Interest
expense
|
—
|
(109,102
|
)
|
(109,102
|
)
|
(208,741
|
)
|
||||||
|
Miscellaneous
|
4,500
|
4,297
|
5,796
|
5,206
|
|||||||||
|
Gain
on forgiveness of debt
|
—
|
2,087,531
|
2,087,531
|
—
|
|||||||||
|
Restructuring
expense
|
—
|
(2,521,118
|
)
|
(2,521,118
|
)
|
—
|
|||||||
|
Total
other income (expense)
|
476,523
|
(528,699
|
)
|
(487,017
|
)
|
(190,066
|
)
|
||||||
|
NET
LOSS
|
(5,613,124
|
)
|
(2,348,508
|
)
|
(3,053,399
|
)
|
(815,285
|
)
|
|||||
|
PREFERRED
STOCK DIVIDEND
|
(195,840
|
)
|
—
|
(64,000
|
)
|
—
|
|||||||
|
PREFERRED
STOCK DEEMED DIVIDEND
|
—
|
(1,943,377
|
)
|
(2,077,321
|
)
|
—
|
|||||||
|
ACCRETION
ON CONVERTIBLE PREFERRED STOCK,
SERIES A
|
—
|
—
|
—
|
(69,541
|
)
|
||||||||
|
ACCRETION
ON CONVERTIBLE PREFERRED STOCK
SERIES B
|
—
|
—
|
—
|
(67,267
|
)
|
||||||||
|
NET
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
$
|
(5,808,964
|
)
|
$
|
(4,291,885
|
)
|
$
|
(5,194,720
|
)
|
$
|
(952,093
|
)
|
|
|
BASIC
AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON
SHARE
|
$
|
(0.16
|
)
|
$
|
(0.22
|
)
|
$
|
(0.24
|
)
|
$
|
(0.28
|
)
|
|
|
SHARES
USED IN COMPUTING BASIC AND DILUTED
NET LOSS ATTRIBUTABLE TO COMMON
STOCKHOLDERS PER COMMON SHARE
|
36,487,218
|
19,689,732
|
21,757,424
|
3,455,238
|
|||||||||
See
notes to financial statements.
F-4
NOVELOS
THERAPEUTICS, INC.
STATEMENTS
OF STOCKHOLDERS’ EQUITY (DEFICIENCY)
|
Common
Stock
|
Series
A
Cumulative
Convertible
Preferred
Stock
|
Convertible Preferred
Stock,
Series A
|
Convertible
Preferred
Stock,
Series B
|
||||||||||||||||||||||||||||||||||
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Additional
Paid-in
|
Accumulated
Deficit
|
Treasury
Stock
|
Total
Stockholders’
Equity (Deficiency)
|
||||||||||||||||||||||||||
|
|
|
|
|
Restated
(Note
13)
|
|
|
|
||||||||||||||||||||||||||||||
|
BALANCE
AT JANUARY 1, 2004 (audited)
|
20,000
|
$
|
200
|
—
|
$
|
—
|
2,783
|
$
|
4,078,764
|
2,201
|
$
|
3,687,905
|
$
|
82,696
|
$
|
(11,393,064
|
)
|
$
|
—
|
$
|
(3,543,499
|
)
|
|||||||||||||||
|
Recapitalization
|
4,014,782
|
(160
|
)
|
—
|
—
|
(2,783
|
)
|
(4,148,305
|
)
|
(2,201
|
)
|
(3,755,172
|
)
|
7,903,637
|
—
|
—
|
—
|
||||||||||||||||||||
|
Accretion
on Series A
|
—
|
—
|
—
|
—
|
—
|
69,541
|
—
|
—
|
—
|
(69,541
|
)
|
—
|
—
|
||||||||||||||||||||||||
|
Accretion
on Series B
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
67,267
|
—
|
(67,267
|
)
|
—
|
—
|
||||||||||||||||||||||||
|
Shares
issued in consideration of
cancellation
of escrow agreement
|
391,344
|
4
|
—
|
—
|
—
|
—
|
—
|
—
|
3,909
|
—
|
—
|
3,913
|
|||||||||||||||||||||||||
|
Stock-based
compensation
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7,868
|
—
|
—
|
7,868
|
|||||||||||||||||||||||||
|
Treasury
stock acquired (195,672 shares)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(1,956
|
)
|
(1,956
|
)
|
|||||||||||||||||||||||
|
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(815,285
|
)
|
—
|
(815,285
|
)
|
|||||||||||||||||||||||
|
BALANCE
AT DECEMBER 31, 2004 (audited)
|
4,426,126
|
44
|
—
|
—
|
—
|
—
|
—
|
—
|
7,998,110
|
(12,345,157
|
)
|
(1,956
|
)
|
(4,348,959
|
)
|
||||||||||||||||||||||
|
Issuance
of common stock for financing commitment
|
10,500,000
|
105
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
105
|
|||||||||||||||||||||||||
|
Issuance
of common stock upon conversion
of
convertible debt
|
1,760,000
|
18
|
—
|
—
|
—
|
—
|
—
|
—
|
1,099,982
|
—
|
—
|
1,100,000
|
|||||||||||||||||||||||||
|
Issuance
of common stock in settlement
of
unsecured debt
|
586,351
|
6
|
—
|
—
|
—
|
—
|
—
|
—
|
732,935
|
—
|
—
|
732,941
|
|||||||||||||||||||||||||
|
Issuance
of common stock in restructuring
of
royalty arrangement
|
2,016,894
|
20
|
—
|
—
|
—
|
—
|
—
|
—
|
2,521,098
|
—
|
—
|
2,521,118
|
|||||||||||||||||||||||||
|
Issuance
of common stock in merger
|
4,500,000
|
45
|
—
|
—
|
—
|
—
|
—
|
—
|
(45
|
)
|
—
|
—
|
—
|
||||||||||||||||||||||||
|
Retirement
of treasury stock in merger
|
(195,672
|
)
|
(2
|
)
|
—
|
—
|
—
|
—
|
—
|
—
|
(1,954
|
)
|
—
|
1,956
|
—
|
||||||||||||||||||||||
|
Issuance
of common stock in private placement, net of issuance costs of
$891,383
|
4,000,000
|
40
|
—
|
—
|
—
|
—
|
—
|
—
|
4,108,577
|
—
|
—
|
4,108,617
|
|||||||||||||||||||||||||
|
Issuance
of common stock for placement agent services
|
125,000
|
1
|
—
|
—
|
—
|
—
|
—
|
—
|
156,249
|
—
|
—
|
156,250
|
|||||||||||||||||||||||||
|
Issuance
of common stock for services
|
202,500
|
2
|
—
|
—
|
—
|
—
|
—
|
—
|
527,798
|
—
|
—
|
527,800
|
|||||||||||||||||||||||||
|
Compensation
expense associated with options issued to non-employees
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
113,070
|
—
|
—
|
113,070
|
|||||||||||||||||||||||||
|
Issuance
of cumulative convertible preferred stock, net of issuance costs
of
$336,000
|
—
|
—
|
3,200
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||||
|
Issuance
of warrants in connection with
preferred
stock
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
786,679
|
—
|
—
|
786,679
|
|||||||||||||||||||||||||
|
Beneficial
conversion feature on preferred stock
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2,077,321
|
—
|
—
|
2,077,321
|
|||||||||||||||||||||||||
|
Issuance
of cumulative convertible preferred
stock
in payment of dividends
|
—
|
—
|
64
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||||
|
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(3,053,399
|
)
|
—
|
(3,053,399
|
)
|
|||||||||||||||||||||||
|
BALANCE
AT DECEMBER 31, 2005 (audited)
|
27,921,199
|
279
|
3,264
|
—
|
—
|
—
|
—
|
—
|
20,119,820
|
(15,398,556
|
)
|
—
|
4,721,543
|
||||||||||||||||||||||||
|
Exercise
of stock options
|
75,000
|
1
|
—
|
—
|
—
|
—
|
—
|
—
|
749
|
—
|
—
|
750
|
|||||||||||||||||||||||||
|
Issuance
of common stock for services
|
85,000
|
1
|
—
|
—
|
—
|
—
|
—
|
—
|
144,049
|
—
|
—
|
144,050
|
|||||||||||||||||||||||||
|
Issuance
of common stock in private placement, net of issuance costs of
$1,211,232
|
11,154,073
|
111
|
—
|
—
|
—
|
—
|
—
|
—
|
13,846,663
|
—
|
—
|
13,846,774
|
|||||||||||||||||||||||||
|
Compensation
expense associated with options issued to employees
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
191,974
|
—
|
—
|
191,974
|
|||||||||||||||||||||||||
|
Compensation
expense associated with options issued to non-employees
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
126,468
|
—
|
—
|
126,468
|
|||||||||||||||||||||||||
|
Dividends
paid on preferred stock
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(195,840
|
)
|
—
|
—
|
(195,840
|
)
|
|||||||||||||||||||||||
|
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(5,613,124
|
)
|
—
|
(5,613,124
|
)
|
|||||||||||||||||||||||
|
BALANCE
AT SEPTEMBER 30, 2006 (unaudited)
|
39,235,272
|
$
|
392
|
3,264
|
$
|
—
|
—
|
$
|
—
|
—
|
$
|
—
|
$
|
34,233,883
|
$
|
(21,011,680
|
)
|
$
|
—
|
$
|
13,222,595
|
||||||||||||||||
See
notes to financial statements.
F-5
NOVELOS
THERAPEUTICS, INC.
STATEMENTS
OF CASH FLOWS
|
Nine
Months Ended September 30,
|
Year
Ended December 31,
|
||||||||||||
|
2006
|
2005
|
2005
|
2004
|
||||||||||
|
Unaudited
|
Unaudited
|
Restated
(Note 13)
Audited
|
Audited
|
||||||||||
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||||||||
|
Net
loss
|
$
|
(5,613,124
|
)
|
$
|
(2,348,508
|
)
|
$
|
(3,053,399
|
)
|
$
|
(815,285
|
)
|
|
|
Adjustments
to reconcile net loss to cash used for operating
activities:
|
|||||||||||||
|
Depreciation
and amortization
|
7,192
|
1,303
|
3,244
|
2,538
|
|||||||||
|
Stock-based
compensation
|
462,492
|
168,186
|
399,461
|
7,868
|
|||||||||
|
Gain
on forgiveness of debt
|
—
|
(2,087,531
|
)
|
(2,087,531
|
)
|
—
|
|||||||
|
Loss
on cancellation of escrow agreement
|
—
|
—
|
—
|
1,957
|
|||||||||
|
Common
stock issued for restructuring expense
|
—
|
2,521,118
|
2,521,118
|
—
|
|||||||||
|
Increase
(decrease) in:
|
|||||||||||||
|
Accounts
receivable
|
—
|
12,584
|
12,584
|
100
|
|||||||||
|
Prepaid
expenses and other current assets
|
46,615
|
(50,556
|
)
|
(96,653
|
)
|
(75,219
|
)
|
||||||
|
Accounts
payable and accrued expenses
|
890,611
|
(40,325
|
)
|
(136,538
|
)
|
314,194
|
|||||||
|
Accrued
interest
|
—
|
51,451
|
51,451
|
174,520
|
|||||||||
|
Deferred
revenue
|
—
|
(12,584
|
)
|
(12,584
|
)
|
(100
|
)
|
||||||
|
Deferred
rent
|
—
|
250
|
(250
|
)
|
250
|
||||||||
|
Cash
used in operating activities
|
(4,206,214
|
)
|
(1,784,612
|
)
|
(2,399,097
|
)
|
(389,177
|
)
|
|||||
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||||||||
|
Purchases
of property and equipment
|
(10,716
|
)
|
(22,963
|
)
|
(25,854
|
)
|
—
|
||||||
|
Change
in restricted cash
|
(2,013,860
|
)
|
(195,726
|
)
|
(196,908
|
)
|
—
|
||||||
|
Deferred
financing costs
|
24,612
|
—
|
(24,612
|
)
|
—
|
||||||||
|
Deposits
|
(1,219
|
)
|
(4,798
|
)
|
(4,798
|
)
|
—
|
||||||
|
Cash
used in investing activities
|
(2,001,183
|
)
|
(223,487
|
)
|
(252,172
|
)
|
—
|
||||||
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||||||||
|
Proceeds
from issuance of common stock, net
|
13,846,774
|
3,819,034
|
3,714,868
|
—
|
|||||||||
|
Proceeds
from issuance of Series A 8% cumulative convertible
preferred
stock, net
|
—
|
2,680,000
|
2,864,000
|
—
|
|||||||||
|
Dividends
paid to preferred stockholders
|
(195,840
|
)
|
—
|
—
|
—
|
||||||||
|
Proceeds
from exercise of stock option
|
750
|
—
|
—
|
—
|
|||||||||
|
Payments
of long-term debt
|
—
|
(1,840
|
)
|
(1,840
|
)
|
(2,832
|
)
|
||||||
|
Proceeds
from issuance of promissory notes
|
—
|
850,000
|
850,000
|
219,000
|
|||||||||
|
Payment
of promissory notes
|
—
|
(519,000
|
)
|
(519,000
|
)
|
—
|
|||||||
|
Cash
provided by financing activities
|
13,651,684
|
6,828,194
|
6,908,028
|
216,168
|
|||||||||
|
INCREASE
(DECREASE) IN CASH AND EQUIVALENTS
|
7,444,287
|
4,820,095
|
4,256,759
|
(173,009
|
)
|
||||||||
|
CASH
AND EQUIVALENTS AT BEGINNING OF YEAR
|
4,267,115
|
10,356
|
10,356
|
183,365
|
|||||||||
|
CASH
AND EQUIVALENTS AT END OF YEAR
|
$
|
11,711,402
|
$
|
4,830,451
|
$
|
4,267,115
|
$
|
10,356
|
|||||
|
SUPPLEMENTAL
DISCLOSURES OF CASH FLOW
INFORMATION
|
|||||||||||||
|
Cash
paid during the year for:
|
|||||||||||||
|
Interest
|
$
|
—
|
$
|
57,461
|
$
|
57,461
|
$
|
33,750
|
|||||
|
SUPPLEMENTAL
DISCLOSURES OF NON-CASH ACTIVITIES
|
|||||||||||||
|
Deemed
dividend on preferred stock
|
$
|
—
|
$
|
1,943,377
|
$
|
2,077,321
|
$
|
—
|
|||||
|
Preferred
stock issued in payment of dividends
|
$
|
—
|
$
|
—
|
$
|
64,000
|
$
|
—
|
|||||
|
Common
stock issued for services
|
$
|
144,050
|
$
|
156,250
|
$
|
156,250
|
$
|
—
|
|||||
|
Common
stock issued on conversion of promissory notes
|
$
|
—
|
$
|
1,100,000
|
$
|
1,100,000
|
$
|
—
|
|||||
|
Common
stock issued to repay notes payable
|
$
|
—
|
$
|
638,719
|
$
|
638,719
|
$
|
—
|
|||||
|
Common
stock issued in exchange for accounts payable
|
$
|
—
|
$
|
544,221
|
$
|
544,221
|
$
|
—
|
|||||
|
Common
stock issued for accrued interest
|
$
|
—
|
$
|
100,000
|
$
|
100,000
|
$
|
—
|
|||||
|
Common
stock issued for prepaid expenses
|
$
|
—
|
$
|
216,000
|
$
|
426,450
|
$
|
—
|
|||||
|
Demand
notes payable forgiven
|
$
|
—
|
$
|
610,212
|
$
|
610,212
|
$
|
—
|
|||||
|
Accounts
payable forgiven
|
$
|
—
|
$
|
773,599
|
$
|
773,599
|
$
|
—
|
|||||
|
Accrued
compensation forgiven
|
$
|
—
|
$
|
360,357
|
$
|
360,357
|
$
|
—
|
|||||
|
Accrued
interest forgiven
|
$
|
—
|
$
|
343,363
|
$
|
343,363
|
$
|
—
|
|||||
|
Accrued
liability for amounts included in prepaid expenses
|
$
|
—
|
$
|
372,450
|
$
|
—
|
$
|
—
|
|||||
See
notes to financial statements.
F-6
Novelos
Therapeutics, Inc.
Notes
to Financial Statements
(ALL
INFORMATION AS OF AND FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2005 AND PERIODS
SUBSEQUENT TO DECEMBER 31, 2005 IS UNAUDITED)
1.
NATURE OF BUSINESS
Novelos
Therapeutics, Inc. (‘‘Novelos’’ or on or after June 13, 2005, the ‘‘Company’’)
was incorporated on June 21, 1996 as AVAM International, Inc. (‘‘AVAM’’). On
October 6, 1998, Novelos Therapeutics, Inc., a newly incorporated entity, merged
into AVAM, and the name of AVAM was changed to Novelos Therapeutics, Inc. See
Note 3 regarding the merger and restructuring that occurred during 2005. Novelos
owns exclusive worldwide intellectual property rights (excluding Russia and
other states of the former Soviet Union) related to certain clinical compounds
and other pre-clinical compounds based on oxidized glutathione. Novelos focuses
on therapeutics for the treatment of various cancers and infectious
diseases.
The
Company is subject to a number of risks similar to those of other companies
in
an early stage of development. Principal among these risks are dependence on
key
individuals, competition from substitute products and larger companies, the
successful development and marketing of its products in a highly regulated
environment, and the need to obtain additional financing necessary to fund
future operations.
2.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use
of Estimates —
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities
and
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting periods. Actual results could differ from those
estimates.
Cash
Equivalents —
The
Company considers all short-term investments purchased with original maturities
of three months or less to be cash equivalents.
Restricted
Cash —
Restricted cash at December 31, 2005 represents cash placed in escrow as
contractually required under an employment agreement with an officer. At
September 30, 2005, restricted cash also includes $2,058,330 of cash pledged
as
security on a letter of credit agreement with a bank. See Note 10.
Property
and Equipment —
Property and equipment are stated at cost. Depreciation on property and
equipment is provided using the straight-line method over the estimated useful
lives of the assets, which range from three to five years. Leasehold
improvements are depreciated over the lesser of the estimated useful lives
of
the assets or the remaining lease term.
Revenue
Recognition —
Revenue
from sales of samples is recognized when persuasive evidence of an arrangement
exists, the price is fixed and determinable, delivery has occurred, and there
is
reasonable assurance of collection.
Research
under collaborative research and development agreements will be recognized
as
research is performed under the terms of the agreements, when there is an
obligation to pay, and when no future performance obligations exist.
Consideration received in advance, whether cash, equity securities or other
instruments, is initially recorded as deferred revenue and recognized when
earned. Revenue earned upon the attainment of research or product development
milestones will be recognized over the terms of the related agreements, once
all
contingencies are eliminated, after taking into consideration the cost to date
and the estimated total cost of the research activities.
Research
and Development —
Research and development costs are expensed as incurred.
Income
Taxes —
The
Company accounts for income taxes under the provisions of Statement of Financial
Accounting Standards (‘‘SFAS’’) No. 109, Accounting
for Income Taxes (‘‘SFAS
109’’). SFAS 109 requires the recognition of deferred tax liabilities and assets
for the expected future tax consequences of temporary differences between the
carrying amounts and the tax bases of assets and liabilities using enacted
tax
rates in effect in the years in which the differences are expected to
reverse.
F-7
Comprehensive
Income (Loss) —
The
Company had no components of comprehensive income other than net loss in all
of
the periods presented.
Concentration
of Credit Risk —
The
Company maintains deposits in financial institutions, which may exceed federally
insured limits. Senior management continually reviews the financial stability
of
these institutions.
Impairment
of Long-Lived
Assets —
At
each
balance sheet date, the Company assesses whether there has been an impairment
in
the value of long-lived assets by determining whether projected undiscounted
cash flows generated by the applicable asset exceed its net book value as of
the
assessment date. There were no impairments of the Company’s assets at the end of
each period presented.
New
Accounting Pronouncements —
In
September 2006, the Financial Accounting Standards Board (“FASB”) issued SFAS
No. 157, Fair
Value Measurements (“SFAS
157”), to define fair value, establish a framework for measuring fair value in
generally accepted accounting principles and expand disclosures about fair-
value measurements. SFAS 157 is effective for financial statements issued for
fiscal years beginning after November 15, 2007 and interim periods within those
fiscal years, with earlier application allowed. The Company is currently
evaluating the effect of this standard on its future reported financial position
and results of operations.
In
February 2006, the FASB issued SFAS No. 155, Accounting
for Certain Hybrid Financial Instruments—an
amendment of FASB Statements No. 133 and 140 (“SFAS
155”), to simplify and make more consistent the accounting for certain financial
instruments. SFAS 155 amends SFAS No. 133, Accounting
for Derivative Instruments and Hedging Activities,
to
permit fair-value remeasurement for any hybrid financial instrument with an
embedded derivative that otherwise would require bifurcation, provided that
the
whole instrument is accounted for on a fair-value basis. SFAS 155 amends SFAS
No. 140, Accounting
for the Impairment or Disposal of Long-Lived Assets,
to
allow a qualifying special-purpose entity to hold a derivative financial
instrument that pertains to a beneficial interest other than another derivative
financial instrument. SFAS 155 applies to all financial instruments acquired
or
issued after the beginning of an entity's first fiscal year that begins after
September 15, 2006, with earlier application allowed. This standard is not
expected to have a significant effect on the Company’s future reported financial
position or results of operations.
In
May
2005, the Financial Accounting Standards Board issued SFAS No. 154, Reporting
Accounting Changes in Interim Financial Statements (‘‘SFAS
154’’),
which
replaces APB Opinion No. 20, Accounting
Changes, and
SFAS
No. 3, Reporting
Accounting Changes in Interim Financial Statements,
and
changes the requirements for the accounting for and reporting of a change in
accounting principle. SFAS 154 applies to all voluntary changes in accounting
principle. It also applies to changes required by an accounting pronouncement
in
the unusual instance that the pronouncement does not include specific transition
provisions. When a pronouncement includes specific transition provisions, those
provisions should be followed. SFAS 154 became effective for the Company
beginning January 1, 2006 and is not expected to have a material impact on
the
Company’s financial position or results of operations.
Reclassifications —
Certain
amounts in prior periods have been reclassified to conform to the current period
presentation.
Unaudited
Interim Financial Information — The
financial information as of and with respect to the nine months ended September
30, 2005 and all periods subsequent to December 31, 2005 is unaudited. In the
opinion of management, such information includes all normal and recurring
adjustments necessary for a fair presentation of results for the interim
periods. Operating results for the interim periods presented are not necessarily
indicative of the results that may be expected for the year ending
December 31, 2006.
3.
REVERSE MERGER AND RESTRUCTURING
On
May
26, 2005, indebtedness of Novelos in the amount of $3,139,185 was exchanged
for
586,351 shares of common stock of Novelos with an aggregate deemed value of
$732,941 and cash in the amount of $318,714, which resulted in forgiveness
of
debt income of $2,087,531. Also on May 26, 2005,
holders of convertible notes of Novelos in the principal amount of $1,100,000
converted their notes into 1,760,000 shares of common stock of Novelos at a
price of $0.625 per share. In addition, Novelos amended an arrangement for
future royalty payments to a related party (see Note 11), which resulted in
the
issuance of 2,016,894 shares of its common stock with an aggregate deemed value
of $2,521,118. These amounts have been reflected in Novelos’ Statements of
Operations as ‘‘Gain on forgiveness of debt’’ and ‘‘Restructuring
expense.’’
F-8
On
May
26, 2005, Nove Acquisition, Inc., a wholly-owned subsidiary of Common Horizons,
Inc., a Nevada corporation (‘‘Common Horizons’’), merged with and into Novelos
such that Novelos was the surviving corporation and became a wholly-owned
subsidiary of Common Horizons. All outstanding shares of common stock of Novelos
were converted into an equal number of shares of common stock of Common
Horizons. In addition, each option and warrant to acquire shares of common
stock
of Novelos was converted into the right to acquire an equal number of shares
of
common stock of Common Horizons at the exercise price stated in the original
option or warrant. All treasury stock (195,672 shares) was retired.
On
May
27, 2005, Common Horizons sold 87 units, each unit consisting of 20,000 shares
of common stock and warrants expiring on August 9, 2008 to purchase 10,000
shares of common stock at a purchase price of $2.25 per share (a ‘‘Unit’’), in a
private placement transaction to accredited investors. As a result of the sale
of these units, Common Horizons issued 1,740,000 shares of common stock and
warrants to purchase 870,000 shares of common stock. Common Horizons received
$1,725,000 in cash as a result of such sale of Units. Holders of convertible
debt of Common Horizons in the amount of $450,000 converted the debt into 18
of
the 87 Units. In connection with the closing, Common Horizons paid commissions
and finders fees consisting of $217,500 in cash and issued warrants expiring
August 9, 2010 to purchase 152,000 shares of common stock of Common Horizons
at
an initial exercise price of $2.00 per share.
On
May
27, 2005, as a result of the transactions described above, there were
approximately 25,458,700 shares of common stock of Common Horizons issued and
outstanding and options and warrants to purchase up to 2,202,651 and 1,764,000
shares, respectively, of common stock of Common Horizons issued and
outstanding.
On
June
13, 2005, Common Horizons merged with and into its wholly-owned subsidiary,
Novelos. Each stockholder of Common Horizons received one share of common stock,
par value $0.00001 per share, of Novelos for each share of common stock, par
value $0.001 per share, of Common Horizons. All but 4,500,000 shares of Common
Horizons common stock was canceled. In addition, each option and warrant to
acquire shares of common stock of Common Horizons was converted into the right
to acquire an equal number of shares of common stock of Novelos at the exercise
price stated in the original option or warrant.
On
June
29, 2005, the Company completed a second closing of its private placement of
Units. The Company sold 33 Units for aggregate gross proceeds of $825,000.
The
Company issued to the accredited investors an aggregate of 660,000 shares of
its
common stock and warrants to purchase an aggregate of 330,000 shares of its
common stock. In connection with this second closing, the Company paid
commissions and finders fees consisting of $80,500 and issued warrants expiring
August 9, 2010 to purchase 64,000 shares of common stock of the Company at
an
initial exercise price of $2.00 per share.
On
July
29, 2005, the Company completed a third closing of its private placement of
Units. The Company sold 46 Units, which resulted in aggregate gross proceeds
to
the Company of $1,150,000. The Company issued to the accredited investors an
aggregate of 920,000 shares of its common stock and warrants to purchase an
aggregate of 460,000 shares of its common stock. In connection with this
closing, the Company paid commissions and finders fees consisting of $105,000
and issued warrants expiring August 9, 2010 to purchase 82,000 shares of common
stock of the Company at an initial exercise price of $2.00 per
share.
On
August
9, 2005, the Company completed a fourth closing of its private placement of
Units. The Company sold 34 Units, receiving $750,000 in cash as a result of
such
sale, and converted accrued interest of $100,000 into Units. The Company issued
to the accredited investors an aggregate of 680,000
shares of its common stock and warrants to purchase an aggregate of 340,000
shares of its common stock. In connection with this closing, the Company paid
finders fees consisting of $58,000 and issued warrants expiring August 9, 2010
to purchase 42,000 shares of common stock of the Company at an initial exercise
price of $2.00 per share.
F-9
On
August
9, 2005, the Company repaid certain stockholder loans in the principal amount
of
$500,000 advanced in December 2004 and January 2005 and more fully described
in
Note 8 with proceeds from the private placement of Units.
In
connection with the private placement of Units (collectively referred to as
the
“2005 PIPE”), vFinance Investments, Inc. and Mercer Capital, Ltd. acted as
placement agents, on a best efforts basis. The placement agent agreement
provided that the placement agents receive 8% of the gross proceeds of the
Units
sold by or through the efforts of the placement agents, a nonaccountable expense
allowance of 2% of the gross proceeds of all Units sold in the offering, and
reimbursement for additional expenses of up to $40,000 to cover their due
diligence investigation of the Company and their legal fees and expenses. In
addition, the placement agents received warrants to purchase 218,000 shares
of
common stock of the Company representing 10% of the total number of shares
of
common stock of the Company sold by or through the efforts of the placement
agents, all of which are included in the amounts described as warrants issued
for commissions and finders fees for each closing above. The placement agents
also received 125,000 shares of common stock of Common Horizons upon the initial
sale of Units. The Company also paid similar fees (cash and warrants) to finders
who introduced the Company to certain investors. In total Novelos issued
warrants to purchase 340,000 shares of common stock to finders and placement
agents at an initial exercise price of $2.00 per share as compensation. The
estimated fair value of these warrants was $1.94 per share using the
Black-Scholes option-pricing model with 80% volatility, a 5 year life and
risk-free interest rates ranging from 3.77%-4.25%.
The
sale
of the Series A preferred stock and warrants described in Note 5, resulted
in an
anti-dilution adjustment to the exercise price of the outstanding warrants
described above. Such adjustment reduced the exercise price of such warrants
from $2.00 and $2.25 to $1.65 per share of common stock.
The
sale
of common stock and warrants also described in Note 5 resulted in a further
anti-dilution adjustment to the exercise price and number of the outstanding
warrants described above. The adjustment reduced the exercise price of such
warrants from $1.65 to $1.35 per share of common stock. See Note 5 for a summary
of warrants outstanding at September 30, 2005.
The
Company was obligated to file a registration statement covering the shares
of
common stock issued and issuable in the 2005 PIPE within 60 days (October 8,
2005) and to cause the registration statement to be declared effective within
180 days (February 5, 2006) following the last closing date of such sale of
Units. The Company is obligated to pay the investors an amount equal to two
percent (2%) of the purchase price of the Units purchased by them for each
30-day period following such date that the registration statement has not been
filed or declared effective, as the case may be. The Company has obtained
waivers of this requirement from substantially all of the unit holders and
has
recorded a liability of $8,000 and $33,000 as of September 30, 2006 and December
31, 2005, respectively, for such payments. If the Company fails to pay any
partial liquidated damages in full within seven days after the date payable,
the
Company will pay interest thereon at a rate of 15% per annum. The registration
statement was filed on November 16, 2005 and was declared effective on December
15, 2005. The use of the registration statement was subsequently suspended
(see
Note 13).
4.
FIXED ASSETS
Fixed
assets consisted of the following at December 31:
|
2005
|
2004
|
||||||
|
Office
equipment
|
$
|
49,717
|
$
|
26,364
|
|||
|
Leasehold
improvements
|
2,500
|
—
|
|||||
|
Total
fixed assets
|
52,217
|
26,364
|
|||||
|
Less
accumulated depreciation and
amortization
|
(29,607
|
)
|
(26,364
|
)
|
|||
|
Fixed
assets, net
|
$
|
22,610
|
$
|
—
|
|||
Included
in fixed assets is equipment under capital lease with a cost of $13,061.
Accumulated depreciation on such equipment was $13,061 at both December 31,
2005
and 2004.
F-10
5.
STOCKHOLDERS’ EQUITY (Restated, see Note 13)
All
outstanding shares of common stock and preferred stock are duly authorized,
validly issued, fully-paid and non-assessable.
Common
Stock
On
March
26, 2004, in accordance with the consent of Novelos’s stockholders, Novelos
effected a 71.3064 for 1 stock split in the form of a stock dividend of 70.3064
shares for stockholders of record on that date. In addition each then
outstanding share of Series A preferred stock was converted into 473.33 shares
of common stock and each outstanding share of Series B preferred stock was
converted into 586.7233 shares of common stock. All shares of Series A and
Series B preferred stock, and accrued dividends thereon, were cancelled upon
exchange for common shares. Concurrent with the stock dividend and conversion
of
Series A and Series B preferred stock, the par value of Novelos’s common stock
was changed from $.01 to $.00001.
Voting.
Holders
of common stock are entitled to one vote per share held of record on all matters
to be voted upon by stockholders. The common stock does not have cumulative
voting rights. Persons who hold a majority of the outstanding common stock
entitled to vote on the election of directors can elect all of the directors
who
are eligible for election.
Dividends.
Subject
to preferences that may be applicable to the holders of any outstanding shares
of preferred stock, the holders of common stock are entitled to receive such
lawful dividends as may be declared by the Company’s board of
directors.
Liquidation
and Dissolution. In
the event of the Company’s liquidation, dissolution or winding up, and subject
to the rights of the holders of any outstanding shares of preferred stock,
the
holders of shares of common stock will be entitled to receive pro
rata
all of
the remaining assets available for distribution to the Company’s
stockholders.
Other
Rights and Restrictions. The
Company’s charter prohibits the granting of preemptive rights to any of the
stockholders. All outstanding shares are fully paid and
nonassessable.
Listing.
The
Company’s common stock is traded on the over-the-counter bulletin board under
the trading symbol “NVLT.OB.”
Series
A 8% Cumulative Convertible Preferred Stock (Restated, see Note
13)
On
September 30, 2005 and October 3, 2005, the Company sold 3,000 and 200 units,
respectively, each unit consisting of a share of its Series A 8% cumulative
convertible preferred stock, par value $0.00001 per share, and warrants to
purchase 303.03 shares of its common stock for a purchase price of $1,000 per
unit. As a result of these transactions, the Company issued 3,000 and 200
shares, respectively, of its Series A preferred stock and warrants to purchase
909,090 and 60,606 shares, respectively, of its common stock. The warrants
expire in five years and had an initial exercise price of $2.00 per share.
The
units were sold to four institutional investors, one of which was a previous
investor in the Company, for aggregate net proceeds of $2,864,000.
The
fair
value of the 969,696 warrants, determined on a relative fair value basis, was
$786,679, which is included in additional paid-in capital. Since the initial
$1.65 conversion price of the preferred stock was less than the market value
at
the time of the closings, the Company determined that this represents a
beneficial conversion feature. After allocating the value of the warrants,
the
intrinsic value of the beneficial conversion feature was determined to be
$4,344,252 in the year ended December 31, 2005 and $4,100,257 in the nine months
ended September 30, 2005. There were not sufficient
net proceeds remaining to allocate the full intrinsic value to the beneficial
conversion feature. Therefore, the remaining net proceeds of $2,077,321 in
the
year ended December 31, 2005 and $1,943,377 in the nine months ended September
30, 2005 were allocated to the beneficial conversion feature and those amounts
were recorded as a deemed dividend in the respective periods.
Voting
Rights: The
Series A preferred stockholders do not have voting rights. The holders of a
majority of the Series A preferred stock, as a class, have the right to
nominate one member for election to the Company’s board of directors for so long
as any shares of Series A preferred stock are outstanding. The preferred
stockholders nominated Michael J. Doyle and he has been elected to the Company’s
board of directors.
F-11
Dividends: The
Series A preferred stock has a dividend rate of 8% per annum, payable quarterly,
which rate increases to 20% per annum on the second anniversary of the date
of
issuance and upon the occurrence of certain events of default specified in
the
certificate of incorporation. Such dividends may be paid in cash or in
additional shares of the Company’s Series A preferred stock. The dividend due
for the quarter ended December 31, 2005 in the amount of $64,000 was paid by
the
issuance of 64 shares of Series A preferred stock with a deemed value of $1,000
per share.
Conversion: Each
share of Series A preferred stock was initially convertible into 606 shares
of
common stock. The Series A preferred stock can be converted only to the
extent that the Series A stockholder will not, as a result of the conversion,
hold in excess of 4.99% of the total outstanding shares of the Company’s common
stock.
Antidilution: Upon
the occurrence of a stock split, stock dividend, combination of the Company’s
common stock into a smaller number of shares, issuance of any of the Company’s
shares or other securities by reclassification of the Company’s common stock,
merger or sale of substantially all of the Company’s assets, the conversion rate
shall be adjusted so that the conversion rights of the Series A preferred stock
stockholders will be equivalent to the conversion rights of the Series A
preferred stock stockholders prior to such event.
Redemption: The
Series A preferred stock is not redeemable at the option of the holder. However,
the Company may redeem the Series A preferred stock for $1,200 per share plus
any accrued but unpaid dividends upon 30 days’ (during which time the Series A
preferred stock may be converted) prior written notice if a registration
statement has been filed with and declared effective by the Securities and
Exchange Commission covering the shares of the Company’s common stock issuable
upon conversion of the Series A preferred stock.
Dissolution: In
the event of any voluntary or involuntary liquidation, dissolution or winding
up
of the Company’s affairs, the Series A preferred stock will be treated as senior
to the Company’s common stock. The Series A preferred stockholders will be
entitled to receive first, $1,000 per share and all accrued and unpaid
dividends. If, upon any winding up of the Company’s affairs, the Company’s
assets available to pay the holders of Series A preferred stock are not
sufficient to permit the payment in full, then all the Company’s assets will be
distributed to the holders of the Company’s Series A preferred stock on a
pro
rata
basis.
The
Company agreed to file a registration statement with the SEC to register 175%
of
the shares of common stock issuable upon conversion of the Series A preferred
stock and 100% of the common stock issuable upon exercise of the warrants within
30 days of the date of issuance of the Series A preferred stock and cause it
to
become effective within 120 days of the date of such issuance. The Company
is
obligated to pay such investors two percent (2%) in cash of the purchase price
of any Series A preferred stock not yet converted and the purchase price of
shares issued upon conversion of the Series A preferred stock for each month
or
portion of a month during which the Company is delinquent with respect to these
registration obligations. The Company obtained a waiver of this requirement
provided that the required registration statement was filed on or before
November 16, 2005. The registration statement was filed on November 16, 2005
and
was declared effective on December 15, 2005. The use of the registration
statement was subsequently suspended (see Note 13).
In
connection with the sale of the Series A preferred stock and warrants, a
stockholder, Ms. Margie Chassman, provided a financial enhancement to the
investors in the form of an escrow of 2,133,000
shares of her common stock, to be drawn upon by the investors if their
investment in the equity securities of the Company fails to provide a specified
yield. In addition, the Company paid $166,000 to Ms. Chassman and her
designee, for providing such financial enhancement. This amount is included
in
the $366,000 of issuance costs netted against the proceeds from the issuance
of
Series A preferred stock as reported in the Statement of Stockholders’ Equity
(Deficiency).
The
sale
of the Series A preferred stock and warrants led to an anti-dilution adjustment
to the exercise price and number of outstanding warrants issued in connection
with the 2005 PIPE. The exercise price per share was reduced from $2.00 and
$2.25 to $1.65 per share.
The
sale
of common stock and warrants in the 2006 PIPE resulted in a further
anti-dilution adjustment to the exercise price of the outstanding warrants
of
the Company. Such adjustment reduced the exercise price of such warrants from
$1.65 to $1.35 per share of common stock and increased the amount of the
outstanding warrants issued in the 2005 PIPE. This sale also resulted in an
anti-dilution adjustment to the conversion price of the Company’s Series A
preferred stock from $1.65 to $1.35. See summary of warrants outstanding at
September 30, 2006 below.
F-12
2006
Private Investment Public Equity (“2006 PIPE”)
On
March
7, 2006, the Company issued 11,154,073 shares of its common stock and warrants
to purchase 8,365,542 shares of its common stock pursuant to a securities
purchase agreement dated March 2, 2006 with 39 accredited investors for
aggregate gross proceeds of $15,058,005. The warrants are exercisable until
March 7, 2011 at an exercise price of $2.50 per share.
The
Company is required to register the resale of the shares of common stock sold
in
the offering and issuable upon exercise of the warrants. The Company is required
to file the registration statement with the Securities and Exchange Commission
within 30 days after the closing and use its best efforts to cause the
registration statement to be declared effective under the Securities Act of
1933, as amended, within 120 days after the closing of the offering. The Company
is required to use its best efforts to keep the registration statement
continuously effective under the Securities Act until the earlier of the date
when all the registerable securities covered by the registration statement
have
been sold or the second anniversary of the closing. In the event that the
registration statement is not filed or declared effective when due, the Company
is obligated to pay the investors liquidated damages in the amount of 1% of
the
purchase price for each month in which the Company is in default. The Company
filed a registration statement covering the common stock and warrants issued
in
connection with the 2006 PIPE on April 6, 2006 and it was declared effective
on
April 19, 2006. The use of the registration statement was subsequently suspended
(see Note 13).
Oppenheimer
& Co., Inc. acted as the placement agent and Rodman & Renshaw, LLC acted
as the sub-placement agent in connection with the offering. The aggregate
commissions payable to Oppenheimer and Rodman & Renshaw in connection with
the private placement were approximately $1,000,000. In addition, the Company
issued warrants to purchase 669,244 shares of common stock to these agents
identical to those sold to the investors. The sale of common stock and warrants
in the 2006 PIPE resulted in an anti-dilution adjustment to the exercise price
of the warrants issued in connection with the 2005 PIPE and Series A preferred
stock. Such adjustment reduced the exercise price of such warrants from $1.65
to
$1.35 per share of common stock. This sale also resulted in an anti-dilution
adjustment to the conversion price of the Company’s Series A preferred stock
from $1.65 to $1.35.
Common
Stock Warrants — The
following table summarizes information with regard to outstanding warrants
issued in connection with equity and debt financings as of September 30,
2006:
|
Offering
|
Outstanding
(as
adjusted)
|
Exercise
Price
(as
adjusted)
|
Expiration
Date
|
|||||||
|
2005
Bridge Loans
|
720,000
|
$
|
0.625
|
April
1, 2010
|
||||||
|
2005
PIPE
|
||||||||||
|
Investors
|
3,333,275
|
$
|
1.35
|
August
9, 2008
|
||||||
|
Placement
Agents/Finders
|
503,692
|
$
|
1.35
|
August
9, 2010
|
||||||
|
Series
A Preferred
|
||||||||||
|
Investors
- September 30, 2005 closing
|
909,090
|
$
|
1.35
|
September
30, 2010
|
||||||
|
Investors
- October 3, 2005 closing
|
60,606
|
$
|
1.35
|
October
3, 2010
|
||||||
|
2006
PIPE
|
||||||||||
|
Investors
|
8,365,542
|
$
|
2.50
|
March
7, 2011
|
||||||
|
Placement
Agents
|
669,244
|
$
|
2.50
|
March
7, 2011
|
||||||
|
Total
|
14,561,449
|
|||||||||
None
of
the above warrants have been exercised as of September 30, 2006.
On
April
1, 2005, in connection with the issuance of $450,000 bridge notes payable,
the
Company issued warrants to purchase 720,000 shares of Novelos stock at $0.625
per share that expire in 5 years.
Reserved
Shares —
At
September 30, 2006 and December 31, 2005, 73,873 shares of common stock were
reserved for issuance upon exercise of options granted under the 2000 plan;
7,482,786 shares of common stock were reserved for issuance upon exercise of
other outstanding options and warrants; up to 3,393,938 shares of common stock
were reserved for issuance pursuant to outstanding convertible preferred stock.
At September 30, 2006, 5,000,000 shares of common stock were reserved for
issuance under the 2006 Stock Incentive Plan.
F-13
6.
STOCK-BASED COMPENSATION
The
Company’s stock-based compensation plans are summarized below:
2000
Stock Option Plan. The
Company's incentive stock option plan established in August 2000 (the “2000
Plan”) provides for grants of options to purchase up to 73,873 post-split shares
of common stock. Grants may be in the form of incentive stock options or
nonqualified options. The board of directors determines exercise prices and
vesting periods on the date of grant. Options generally vest annually over
three
years and expire on the tenth anniversary of the grant date. No options were
granted, exercised or cancelled under the 2000 Plan during 2005 or during the
nine-month period ending September 30, 2006.
2006
Stock Incentive Plan.
On May
1, 2006, the Company’s board of directors adopted and on July 21, 2006 the
Company’s stockholders approved, the 2006 Stock Incentive Plan (the “2006
Plan”). A total of 5,000,000 shares of common stock are reserved for issuance
under the 2006 Plan for grants of incentive or nonqualified stock options,
rights to purchase restricted and unrestricted shares of common stock, stock
appreciation rights and performance share grants. A committee of the board
of
directors determines exercise prices, vesting periods and any performance
requirements on the date of grant, subject to the provisions of the 2006 Plan.
Options are granted at or above the fair market value of the common stock at
the
grant date and expire on the tenth anniversary of the grant date. In the nine
months ended September 30, 2006, stock options for the purchase of 210,000
shares of common stock were granted under the 2006 Plan.
Other
Stock Option Activity.
During
2005 and 2004, the Company issued stock options to employees, directors and
consultants outside of any formalized plan. These options are exercisable within
a ten-year period from the date of grant, and vest at various intervals with
all
options being fully vested within two-to-three years of the grant date. The
options are not transferable except by will or domestic relations order. The
option price per share is not less than the fair market value of the shares
on
the date of the grant. During the nine months ended September 30, 2006, options
to purchase 75,000 shares were exercised. There have been no other exercises.
Adoption
of SFAS No. 123(R)
Effective
January 1, 2006, the Company adopted the fair-value recognition provisions
of
Statement of Financial Accounting Standards (“SFAS”) No. 123(R),
Share-Based Payment
(“SFAS
123R”), using the modified-prospective-transition method. SFAS 123R requires all
share-based payments to employees including grants of employee stock options
to
be recognized in the financial statements based on their fair values. SFAS
123R
did not change the accounting guidance for share-based payments granted to
non-employees provided in SFAS No. 123,
Accounting for Stock Based Compensation (“SFAS
123”), as originally issued and Emerging Issues Task Force (“EITF”) No. 96-18,
Accounting
for Equity Instruments That Are Issued to Other Than Employees for Acquiring,
or
in Conjunction with Selling, Goods or Services.
EITF
96-18 requires that companies recognize compensation expense based on the
estimated fair value of options granted to non-employees over their vesting
period, which is generally the period during which services are rendered by
such
non-employees. The fair value of unvested non-employee stock awards is
re-measured at each reporting period.
Under
the
modified prospective transition method, compensation cost recognized for the
nine months ended September 30, 2006 includes: (a) compensation cost for all
stock-based payments granted, but not yet vested as of January 1, 2006, based
on
the grant-date fair value estimated in accordance with the original provisions
of SFAS 123, and (b) compensation cost for all stock-based payments granted
subsequent to January 1, 2006, based on the grant-date fair value estimated
in
accordance with the provisions of SFAS 123R. Results for prior periods have
not
been restated. As a result of the adoption of SFAS 123R, the Company recorded
incremental stock-based compensation expense of $191,974 in the nine months
ended September 30, 2006.
F-14
During
the years ended December 31, 2005 and 2004, the Company accounted for stock
option awards granted to directors and employees (collectively, employees)
under
the recognition and measurement principles of Accounting Principles Board
Opinion (‘‘APB’’) No. 25, Accounting
for Stock Issued to Employees, (“APB
25”). Under this method compensation cost is recognized for the amount by which
the market price of the stock on the date of grant exceeds the exercise price
of
the option. For the years ended December 31, 2005 and 2004, there was no
stock-based employee compensation cost recorded for options granted to employees
under the plan as none have been granted at exercise prices below the fair
market value of the underlying stock. For those options granted at exercise
prices equal to or greater than the fair market value of the underlying stock
on
the date of the grant, the Company applied the disclosure-only provision of
SFAS
123.
The
following table summarizes amounts charged to expense for stock-based
compensation related to employee and director stock option grants and
stock-based compensation recorded in connection with stock options and
restricted stock awards granted to non-employee consultants:
|
Nine
Months Ended
September
30,
|
Year
Ended
December
31,
|
||||||||||||
|
2006
|
2005
|
2005
|
2004
|
||||||||||
|
Employee
and director stock option grants:
|
|||||||||||||
|
Research
and development
|
$
|
139,050
|
$
|
—
|
$
|
—
|
$
|
—
|
|||||
|
General
and administrative
|
52,924
|
—
|
—
|
—
|
|||||||||
|
191,974
|
—
|
—
|
—
|
||||||||||
|
Non-employee
consultants stock option grants and restricted stock
awards:
|
|||||||||||||
|
Research
and development
|
3,969
|
67,215
|
67,215
|
—
|
|||||||||
|
General
and administrative
|
266,549
|
100,971
|
332,246
|
7,868
|
|||||||||
|
270,518
|
168,186
|
399,461
|
7,868
|
||||||||||
|
Total
stock-based compensation
|
$
|
462,492
|
$
|
168,186
|
$
|
399,461
|
$
|
7,868
|
|||||
Determining
Fair Value
Valuation
and amortization method.
The
fair value of each stock award is estimated on the grant date using the
Black-Scholes option-pricing model. The estimated fair value of employee stock
options is amortized to expense using the straight-line method over the vesting
period.
Volatility.
Volatility is determined based on the Company’s estimate of fluctuation in its
common stock price and its review of comparable public company data due to
the
limited amount of time that the Company’s common stock has been publicly traded.
Risk-free
interest rate.
The
risk-free interest rate is based on the U.S. Treasury yield curve in effect
at
the time of grant commensurate with the expected life assumption.
Expected
term.
The
expected term of stock options granted is based on the Company’s estimate of
when options will be exercised in the future as there have been limited stock
option exercises to date. The expected term is generally applied to one group
as
a whole as the Company does not expect substantially different exercise or
post-vesting termination behavior within its employee population. The expected
term of options that were granted prior to the Company’s stock becoming publicly
traded was generally longer (10 years) than is currently estimated.
Forfeitures.
As
required by SFAS 123R, the Company records share-based compensation expense
only
for those awards that are expected to vest. SFAS 123R requires forfeitures
to be
estimated at the time of grant and revised, if necessary, in subsequent periods
if actual forfeitures differ from those estimates. The term “forfeitures” is
distinct from “cancellations” or “expirations” and represents only the unvested
portion of the surrendered option. The Company has applied an annual forfeiture
rate of 0% to all unvested options as of September 30, 2006 as the Company
believes that there is insufficient history to develop an accurate estimate
of
future forfeitures. This analysis will be re-evaluated quarterly and the
forfeiture rate will be adjusted as necessary. Ultimately, the actual expense
recognized over the vesting period will be for only those shares that
vest.
F-15
The
following table summarizes weighted average values and assumptions used for
options granted to employees, directors and consultants in the periods
indicated:
|
|
Nine
Months Ended
September
30,
|
Year
Ended
December
31,
|
|||||||||||
|
|
2006
|
2005
|
2005
|
2004
|
|||||||||
|
(Unaudited)
|
(Unaudited)
|
||||||||||||
|
Volatility
|
80
|
%
|
0-80
|
%
|
0%-80
|
%
|
0
|
%
|
|||||
|
Weighted-average
volatility
|
80
|
%
|
20.1
|
%
|
23
|
%
|
0
|
%
|
|||||
|
Risk-free
interest rate
|
4.59%-5.05
|
%
|
3.84%-4.81
|
%
|
3.95%-4.81
|
%
|
3.95%-4.81
|
%
|
|||||
|
Expected
life (years)
|
5-10
|
5-10
|
2-10
|
10
|
|||||||||
|
Dividend
|
0
|
0
|
0
|
0
|
|||||||||
|
Weighted-average
exercise price
|
$
|
1.23
|
$
|
0.66
|
$
|
0.78
|
$
|
0.01
|
|||||
|
Weighted-average
grant-date fair value
|
$
|
0.56
|
$
|
0.45
|
$
|
0.49
|
$
|
0.00
|
|||||
Pro-Forma
Information Under SFAS 123 for Periods Prior to January 1,
2006
The
following table illustrates the effect on net loss and net loss per share had
the Company applied the fair-value recognition provisions of SFAS 123R in the
periods prior to adoption. For purposes of this pro-forma disclosure, the value
of the options is estimated using the Black-Scholes option-pricing model and
amortized to expense over the options’ vesting periods.
|
Nine
Months Ended September 30,
|
Year
Ended December 31,
|
|||||||||
|
2005
|
2005
|
2004
|
||||||||
|
Restated
(Note
13)
Unaudited
|
Restated
(Note
13)
|
|||||||||
|
Net
loss attributable to common stockholders as reported
|
$
|
(4,291,885
|
)
|
$
|
(5,194,720
|
)
|
$
|
(952,093
|
)
|
|
|
Stock-based
employee compensation expense determined under
fair-value-based method
|
(50,244
|
)
|
(111,082
|
)
|
(5,272
|
)
|
||||
|
Pro
forma net loss attributable to common stockholders
|
$
|
(4,342,129
|
)
|
$
|
(5,305,802
|
)
|
$
|
(957,365
|
)
|
|
|
Basic
and diluted net loss attributable to common stockholders per
share:
|
||||||||||
|
As
reported
|
$
|
(0.22
|
)
|
$
|
(0.24
|
)
|
$
|
(0.28
|
)
|
|
|
Pro
forma
|
$
|
(0.22
|
)
|
$
|
(0.24
|
)
|
$
|
(0.28
|
)
|
|
Stock
Option Activity
A
summary
of stock option activity under the 2000 Plan, the 2006 Plan and outside of
any
formalized plan is as follows:
|
|
Options
Outstanding
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contracted
Term in
Years
|
Aggregate
Intrinsic
Value
|
|||||||||
|
Outstanding
at January 1, 2004
|
73,873
|
$
|
3.16
|
||||||||||
|
Options
granted
|
1,286,000
|
$
|
0.01
|
||||||||||
|
Options
forfeited
|
(407,222
|
)
|
$
|
0.01
|
|||||||||
|
Outstanding
at December 31, 2004
|
952,651
|
$
|
0.26
|
||||||||||
|
Options
granted
|
1,775,000
|
$
|
0.78
|
||||||||||
|
Outstanding
at December 31, 2005
|
2,727,651
|
$
|
0.60
|
8.9
|
$
|
4,294,257
|
|||||||
|
Options
granted
|
210,000
|
$
|
1.23
|
||||||||||
|
Options
exercised
|
(75,000
|
)
|
$
|
0.01
|
|||||||||
|
Outstanding
at September 30, 2006
|
2,862,651
|
$
|
0.66
|
8.3
|
$
|
1,836,718
|
|||||||
|
Exercisable
at September 30, 2006
|
2,230,312
|
$
|
0.41
|
8.1
|
$
|
1,700,076
|
|||||||
F-16
The
aggregate intrinsic value of options outstanding is calculated based on the
positive difference between the closing market price of the Company’s common
stock at the end of the respective period and the exercise price of the
underlying options. The weighted average grant-date fair value of options
granted in the nine months ended September 30, 2006 was $0.56 per share. The
weighted average grant-date fair value of options granted in the year ended
December 31, 2005 was $0.50. During the nine months ended September 30, 2006,
the total intrinsic value of options exercised was $134,250 and the total amount
of cash received from exercise of these options was $750.
The
following tables summarize information about stock options outstanding at
September 30, 2006:
|
Options
Outstanding
|
Options
Exercisable
|
|||||||||||||||
|
Exercise
Price
|
Number
of
Shares
|
Weighted
Average Remaining
Contractual Life (Years)
|
Weighted
Average Exercise Price
|
Number
of Shares
|
Weighted
Average Exercise Price
|
|||||||||||
|
$
0.01
|
2,053,778
|
8.1
|
$
|
0.01
|
1,900,627
|
$
|
0.01
|
|||||||||
|
$
0.70 - $1.95
|
255,705
|
9.2
|
$
|
1.14
|
51,517
|
$
|
0.88
|
|||||||||
|
$
2.00 - $3.22
|
525,000
|
8.9
|
$
|
2.63
|
250,000
|
$
|
2.65
|
|||||||||
|
$
7.01
|
28,168
|
5.8
|
$
|
7.01
|
28,168
|
$
|
7.01
|
|||||||||
|
2,862,651
|
8.30
|
$
|
0.66
|
2,230,312
|
$
|
0.41
|
||||||||||
As
of
September 30, 2006, there was approximately $462,000 of total unrecognized
compensation cost related to unvested share-based compensation arrangements.
This cost is expected to be recognized over a weighted average period of
1.25
years. The Company expects 632,339 in unvested options to vest in the
future.
7.
INCOME TAXES
The
Company’s deferred tax assets consisted of the following at December
31:
|
2005
|
2004
|
||||||
|
Net
operating loss carryforwards
|
$
|
4,723,000
|
$
|
2,068,000
|
|||
|
Depreciation
and amortization
|
—
|
8,000
|
|||||
|
License
fee
|
—
|
99,000
|
|||||
|
Research
and development
expenses
|
164,000
|
—
|
|||||
|
Accrued
compensation
|
—
|
360,000
|
|||||
|
Accrued
interest
|
—
|
320,000
|
|||||
|
Tax
credits
|
282,000
|
380,000
|
|||||
|
Capital
loss carryforward
|
403,000
|
380,000
|
|||||
|
Gross
deferred tax asset
|
5,572,000
|
3,615,000
|
|||||
|
Valuation
allowance
|
(5,572,000
|
)
|
(3,615,000
|
)
|
|||
|
Net
deferred tax asset
|
$
|
—
|
$
|
—
|
|||
F-17
Because
of the Company’s limited operating history, management has provided a 100%
reserve against the Company’s net deferred tax assets for all periods.
Management provided a valuation allowance due to the uncertainty associated
with
the utilization of the net operating loss carryforwards in the future. The
valuation allowance was $5,272,000 and $3,615,000 at December 31, 2005 and
2004,
respectively. As of December 31, 2005, the Company had net operating loss
carryforwards of approximately $10,400,000, which begin to expire in 2011 for
federal purposes. The Company’s research and development credits are available
to offset future federal income tax, subject to limitations for alternative
minimum tax. The research and development credit carryforwards begin to expire
in 2011.
The
capital loss carryforward relates to the loss recorded in prior years for
Novelos’ investment in an unrelated company.
Under
the
provisions of the Internal Revenue Code, certain substantial changes in the
Company’s ownership may have limited, or may limit in the future, the amount of
net operating loss carryforwards which could be utilized annually to offset
future taxable income and income tax liabilities. The amount of any limitation
is determined based on the Company’s value and the long-term tax-exempt rate on
the date of an ownership change.
8.
NOTES PAYABLE TO STOCKHOLDERS
Since
inception, Novelos has relied on private investors to fund its operations.
Periodically, these investors have advanced monies to Novelos evidenced by
notes
payable or other written agreements.
Novelos
had outstanding unsecured demand notes in the principal amount of $817,931
at
December 31, 2004. These notes bore interest at 6%. At December 31, 2004, these
notes included $521,931 of converted accrued compensation owed to officers,
$100,000 of converted accrued consulting expense owed to a stockholder of
Novelos and $196,000 in cash advances from stockholders.
The notes related to converted compensation totaling $621,931 were forgiven
by
the stockholders. The remaining notes were repaid through the issuance of stock
with a deemed value of $177,000 and cash of $19,000. Therefore, there were
no
unsecured demand notes outstanding at December 31, 2005.
On
May
25, 2004, Novelos obtained a bridge loan in the amount of $100,000 from a
stockholder. This loan bore interest at 15% and became due and payable on May
25, 2005. On November 25, 2003, Novelos received $900,000 from certain
stockholders in new secured debt financing through the issuance of ‘‘bridge
loans,’’ bearing interest at 15% and maturing on May 25, 2005. Novelos also
converted an existing $100,000 secured demand note payable into a bridge loan
under the same terms. Under the terms of the loan agreements, the principal
amount of the notes could be converted to common stock at $1.00 per share,
at
the note holder’s option. If the market value of the stock fell below $2.00 per
share, the conversion price would be adjusted downward to a price equal to
one
half of the market value of the stock, with a minimum conversion price of $.38
per common share. In May 2005 these bridge loans were converted into 1,760,000
shares of common stock in accordance with the loan agreements. Therefore, there
were no bridge loans outstanding at December 31, 2005.
In
January 2005 Novelos received $400,000 in the form of a loan from an individual
stockholder. This loan bore interest at 6% per annum and was repayable following
the closing of one or more equity financings that resulted in aggregate gross
proceeds of at least $5,000,000 to the Company. In December 2004 the Company
had
received a $100,000 loan from the same individual stockholder. This loan bore
interest at 6% per annum and was repayable upon the successful completion of
a
proposed ‘‘recapitalization’’ that raised at least $3 million. In exchange for
both of these loans and the individual’s commitment to provide additional
financing of up to $500,000 through August 2005, this individual received in
January 2005 10,000,000 shares of common stock of Novelos. These loans allowed
Novelos to sustain its operations until permanent equity, as described in Note
3, was obtained. The Company closed equity financings by means of the private
placements described in Note 3, which resulted in $5,000,000 in aggregate gross
proceeds to the Company. The Company repaid these loans on August 9, 2005 with
proceeds from these equity financings. Therefore, there were no loans from
stockholders outstanding at December 31, 2005.
F-18
9.
NET LOSS PER SHARE
Basic
net
loss per share is computed by dividing net loss attributable to common
stockholders by the weighted average number of shares of common stock
outstanding during the period. Diluted net loss per share is computed by
dividing net loss attributable to common stockholders by the weighted average
number of shares of common stock and the dilutive potential common stock
equivalents then outstanding. Potential common stock equivalents consist of
stock options, warrants and convertible preferred stock. Since the Company
has a
net loss for all periods presented, the inclusion of stock options and warrants
in the computation would be antidilutive. Accordingly, basic and diluted net
loss per share are the same.
The
following potentially dilutive securities have been excluded from the
computation of diluted net loss per share since their inclusion would be
antidilutive:
|
|
Nine
Months Ended
September
30,
|
Year
Ended
December
31,
|
|||||||||||
|
|
2006
|
2005
|
2005
|
2004
|
|||||||||
|
Stock
options
|
2,862,651
|
2,627,651
|
2,727,651
|
952,651
|
|||||||||
|
Warrants
|
14,561,449
|
4,768,402
|
4,829,008
|
—
|
|||||||||
|
Conversion
of preferred stock
|
2,417,777
|
1,818,182
|
1,939,393
|
—
|
|||||||||
10.
COMMITMENTS
On
August
9, 2006, the Company entered into a one-year lease for office space, commencing
September 1, 2006, at an annual rent of $65,250. Rent expense was $45,563,
$45,355 and $36,100 for the nine months ended September 30, 2006 and the years
ended December 31, 2005 and 2004, respectively.
Novelos
issued 50,000 shares of common stock to a vendor in connection with the
restructuring of debt described in Note 3. Novelos has agreed to reimburse
the
vendor for the shortfall, if any, between the market value of shares still
held
at November 18, 2006, plus any proceeds received as of that date on the sale
of
the shares and $79,000. As of September 30, 2006, $34,000 is included in accrued
expenses representing the estimated obligation in connection with this
agreement.
On
July
15, 2005, the Company entered into an employment agreement with Christopher
J.
Pazoles, Ph.D, whereby he agreed to serve as the Company’s vice president of
research and development for an initial term of two years. His annual salary
is
$192,000 for the first year and $195,000 for the second year. Dr. Pazoles
is also entitled to a minimum cash bonus of $16,000 at the end of the first
year
and $25,000 at the end of the second year. Dr. Pazoles’ agreement provides
that he is entitled to participate in the Company’s employee fringe benefit
plans or programs generally available to the Company’s senior executives. The
agreement further provides that in the event that the Company terminates
Dr. Pazoles without cause or he resigns for good reason (as defined), the
Company will (i) pay Dr. Pazoles his base salary through the remainder of
the term of his employment agreement in monthly installments; (ii) continue
to
provide him benefits for 12 months after the date of termination; and (iii)
pay,
on a prorated basis, any minimum bonus or other payments earned.
F-19
On
January 31, 2006, the Company entered into an employment agreement with Harry
Palmin effective January 1, 2006, whereby he agreed to serve as the Company’s
president and chief executive officer for an initial term of two years at an
annual salary of $225,000. He is eligible to receive an annual cash bonus at
the
discretion of the compensation committee and he is entitled to participate
in
the Company’s employee fringe benefit plans or programs generally available to
the Company’s senior executives. The agreement provides that in the event that
the Company terminates Mr. Palmin without cause or he resigns for good
reason (as defined), the Company will (i) pay Mr. Palmin his pro rata share
of the average of his annual bonus paid during the two fiscal years preceding
his termination; (ii) pay Mr. Palmin his base salary for 11 months after
the date of termination; (ii) continue to provide him benefits for 11 months
after the date of termination; and (iii) fifty percent of his unvested stock
options will vest. The agreement also contains a non-compete provision, which
prohibits Mr. Palmin from competing with the Company for one year after
termination of his employment with the Company
In
July,
2006, the Company entered into a contract with a supplier of pharmaceutical
products that will provide chemotherapy drugs to be used in connection with
Phase 3 clinical trial activities outside of the United States. Pursuant to
the
contract, the Company was obligated to purchase a minimum of approximately
$2.6
million of chemotherapy drugs at specified intervals through March 2008. As
of
September 30, 2006, approximately $1.8 million is remaining under that
commitment. In connection with that agreement, the Company was required to
enter
into a standby letter of credit arrangement with a bank. The balance on the
standby letter of credit at September 30, 2006 equals the remaining purchase
commitment of $1.8 million. In connection with the letter of credit, the Company
has pledged cash of approximately $2.1 million to the bank as collateral on
the
letter of credit. The pledged cash is included in restricted cash at September
30, 2006.
11.
RELATED-PARTY TRANSACTIONS AND COMMITMENTS
Novelos
engaged a contract research organization that is a stockholder of the Company
to
perform research and development services. During the years ended December
31,
2005 and 2004, $200,611 and $39,340 of expenses, respectively, were incurred
under this arrangement. No amount was payable to the stockholder at December
31,
2005. At December 31, 2004, $1,185,321 was payable to the stockholder and was
included in accounts payable. The amount payable at December 31, 2004 was repaid
through the issuance of common stock with a deemed value of $450,000 and the
remaining balance was forgiven by the stockholder.
The
Company is obligated to ZAO BAM, under a royalty and technology transfer
agreement. One of the Company’s former directors is the majority shareholder of
ZAO BAM. Pursuant to the royalty and technology transfer agreement between
the
Company and ZAO BAM, the Company is required to make royalty payments of 1.2%
of
net sales of oxidized glutathione-based products. The Company is also required
to pay ZAO BAM $2 million for each new oxidized glutathione-based drug within
eighteen months following FDA approval of such drug.
The
Company has also agreed to pay ZAO BAM 12% of all license revenues, as defined,
in excess of the Company’s expenditures associated therewith, including but not
limited to, preclinical and clinical studies, testing, FDA and other regulatory
agency submission and approval costs, general and administrative costs, and
patent expenses, provided that such payment be no less than 3% of all license
revenues.
Pursuant
to an agreement that became effective on May 26, 2005, the Company revised
its
arrangement with Oxford Group, Ltd. and is required to pay Oxford Group, Ltd.
a
royalty in the amount of 0.8% of the Company’s net sales of oxidized
glutathione-based products. The Company’s Chairman of the Board of Directors is
president of Oxford Group, Ltd. As described in Note 3, the Company revised
the
arrangement for future royalty payments, which resulted in the issuance of
2,016,894 shares of common stock, including 907,602 shares to each of two
directors of the Company, with an aggregate deemed value of
$2,521,118.
The
obligations to ZAO BAM and Oxford Group resulted from their assignment of the
exclusive intellectual property and marketing rights to a drug development
platform technology, worldwide, excluding
Russia and the states of the former Soviet Union. The royalty payments will
be
recorded as royalty expense when the obligations are incurred. The payment
for
any new technologies will be accounted for as purchased technology and either
capitalized or expensed at the time of payment, depending on the stage of
completion of the related products.
See
Notes
5 and 8 in regard to transactions with certain stockholders.
F-20
12.
SUBSEQUENT EVENTS
On
November 3, 2006, Mark Balazovsky resigned for personal reasons from the
Company’s Board of Directors. Mr. Balazovsky is the majority shareholder of ZAO
BAM (see Note 11).
13.
RESTATEMENT OF PREVIOUSLY ISSUED FINANCIAL
STATEMENTS
Subsequent
to the initial filing of the Company’s annual report on Form 10-KSB for the year
ended December 31, 2005 and the 10-QSB for the quarter and nine months ended
September 30, 2005 (the “Relevant Periods”) and in connection with an internal
review of the terms associated with the Company’s historical financing
transactions, the Company determined that the intrinsic value associated with
the beneficial conversion feature (‘‘BCF’’) of the Company’s Series A 8%
Cumulative Convertible Preferred Stock had not been properly presented as a
deemed (non-cash) dividend nor included in the calculation of net
loss
attributable to common stockholders in the Relevant Periods. In accordance
with
Emerging Issues Task Force Issue (‘‘EITF’’) No. 98-5, Accounting
for Convertible Securities with Beneficial Conversion Features or Contingently
Adjustable Conversion Ratios,
and
EITF No. 00-27, Application
of Issue No. 98-5 to Certain Convertible Instruments,
a
conversion feature that is ‘‘in-the-money’’ based on the market price of a
company’s common stock at the commitment date is considered a BCF. As the terms
of the Series A 8% Cumulative Convertible Preferred Stock allowed immediate
conversion, the deemed (non-cash) dividend related to the BCF should have been
recorded upon issuance.
The
following table sets forth the effects of the restatement on certain line items
within the Company’s Statements of Operations for the year ended December 31,
2005 and nine months ended September 30, 2005:
|
|
As
Previously
Reported
|
Revision
|
As
Restated
|
|||||||
|
Year
Ended December 31, 2005:
|
||||||||||
|
Net
Loss
|
$
|
(3,053,399
|
)
|
$
|
—
|
$
|
(3,053,399
|
)
|
||
|
Preferred
Stock (Non-cash) Dividend (1)
|
—
|
(64,000
|
)
|
(64,000
|
)
|
|||||
|
Preferred
Stock Deemed (Non-cash) Dividend
|
—
|
(2,077,321
|
)
|
(2,077,321
|
)
|
|||||
|
Net
Loss Attributable to Common Stockholders
|
$
|
(3,053,399
|
)
|
$
|
(2,141,321
|
)
|
$
|
(5,194,720
|
)
|
|
|
Basic
and Diluted Net Loss Attributable to Common Stockholders
Per Common Share
|
$
|
(0.14
|
)
|
$
|
(0.10
|
)
|
$
|
(0.24
|
)
|
|
|
Nine
Months Ended September 30, 2005:
|
||||||||||
|
Net
Loss
|
$
|
(2,348,508
|
)
|
$
|
—
|
$
|
(2,348,508
|
)
|
||
|
Preferred
Stock Deemed (Non-cash) Dividend
|
—
|
(1,943,377
|
)
|
(1,943,377
|
)
|
|||||
|
Net
Loss Attributable to Common Stockholders
|
$
|
(2,348,508
|
)
|
(1,943,377
|
)
|
$
|
(4,291,885
|
)
|
||
|
Basic
and Diluted Net Loss Attributable to Common Stockholders Per Common
Share
|
$
|
(0.12
|
)
|
$
|
(0.10
|
)
|
$
|
(0.22
|
)
|
|
|
(1)
|
Represents
a quarterly dividend paid to preferred stockholders in the quarter
ended
December 31, 2005 in the form of additional shares of preferred stock,
as
permitted pursuant to the terms of the related agreement. This amount
was
inadvertently not previously included as an adjustment in arriving
at net
loss attributable to common stockholders. The amount was not material
in
relation to net loss attributable to common stockholders and would
not
have changed the basic and diluted net loss attributable to common
stockholders per common share as
reported.
|
On
October 24, 2006, the Company filed a Current Report on Form 8-K discussing
the
restatement. Following the filing of the Form 8-K, the Company advised the
selling stockholders named in two registration statements related to the resale
of securities purchased in the 2005 PIPE, the Series A 8% Cumulative Convertible
Preferred, and the 2006 PIPE financings that the use of the respective
prospectuses had been suspended. The Company plans to amend these registration
statements as soon as practicable to include the restated financial statements.
Pursuant to the registration rights associated with these financings, the
Company may become obligated to these selling stockholders in the event that
the
suspension of the use of the prospectuses exceeds the grace periods specified.
The amount of such obligation, if any, will not be determined until later in
the
fourth quarter of 2006.
F-21