S-1: General form of registration statement for all companies including face-amount certificate companies
Published on June 3, 2008
As
filed with the Securities and Exchange Commission on June 3,
2008
Registration
No. 333-
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
________________
FORM
S-1
REGISTRATION
STATEMENT UNDER THE SECURITIES ACT OF 1933
________________
NOVELOS
THERAPEUTICS, INC.
(Name
of small business issuer in its charter)
|
Delaware
|
2834
|
04-3321804
|
|
(State
or other jurisdiction
of
incorporation or organization)
|
(Primary
Standard Industrial
Classification
Code Number)
|
(I.R.S.
employer
identification
number)
|
One
Gateway Center
Suite
504
Newton,
Massachusetts 02458
(617)
244-1616
(Address
and telephone number of principal executive offices)
Harry
S. Palmin
President
and Chief Executive Officer
Novelos
Therapeutics, Inc.
One
Gateway Center, Suite 504
Newton,
Massachusetts 02458
(617)
244-1616
(Name,
address and telephone number of agent for service)
Copies
to:
Paul
Bork, Esq.
Foley
Hoag LLP
155
Seaport Boulevard
Boston,
Massachusetts 02110
(617)
832-1000
________________
Approximate
date of proposed sale to the public:
As soon
as practicable after this Registration Statement becomes effective.
If
any of
the securities being registered on this form are to be offered on a delayed
or
continuous basis pursuant to Rule 415 under the Securities Act of 1933
(“Securities Act”), check the following box. x
If
this
Form is filed to register additional securities for an offering pursuant to
Rule
462(b) under the Securities Act, check the following box and list the Securities
Act registration statement number of the earlier effective registration
statement for the same offering. o
If
this
Form is a post-effective amendment filed pursuant to Rule 462(c) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering. o
If
this
Form is a post-effective amendment filed pursuant to Rule 462(d) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering. o
If
delivery of the prospectus is expected to be made pursuant to Rule 434, please
check the following box. o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
See
the definitions of “large accelerated filer,” “accelerated filer,” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
(Check
one):
|
Large accelerated filer
|
o
|
Accelerated filer o
|
|
|
Non-accelerated filer
|
o
|
Smaller reporting company
|
x
|
(Do
not
check if a smaller reporting company)
CALCULATION
OF REGISTRATION FEE
|
Title of Each Class of Securities
to be Registered
|
Amount to be
Registered (1)
|
Proposed
Maximum
Offering Price
Per Share (2)
|
Proposed
Maximum
Aggregate
Offering Price
|
Amount of
Registration
Fee
|
|||||||||
|
Common
Stock, par value $0.00001 per share
|
6,888,413
|
(3)
|
$
|
0.55
|
$
|
3,788,627.15
|
$
|
148.89
|
|||||
|
Total
|
$
|
148.89
|
|||||||||||
| (1) |
Pursuant
to Rule 416 promulgated under the Securities Act of 1933, as amended,
the
shares of common stock offered hereby also include an indeterminate
number
of additional shares of common stock as may from time to time become
issuable by reason of stock splits, stock dividends, recapitalizations
or
other similar transactions.
|
| (2) |
Estimated
based on average of the bid and asked prices of our common stock
as
reported over-the-counter on the OTC Electronic Bulletin Board of
the
National Association of Securities Dealers, Inc. on May 30, 2008
pursuant
to Rule 457(c) promulgated under the Securities Act of
1933.
|
| (3) |
Represents
the number of shares of our common stock issuable upon exercise of
common
stock purchase warrants issued to investors in a private placement
transaction completed on May 27, 2005, June 29, 2005, July 29, 2005
and
August 9, 2005.
|
The
registrant hereby amends this Registration Statement on such date or dates
as
may be necessary to delay its effective date until the registrant shall
file a further amendment which specifically states that this Registration
Statement shall thereafter become effective in accordance with Section 8(a)
of the Securities Act of 1933 or until the Registration Statement shall become
effective on such date as the Commission, acting pursuant to said
Section 8(a), may determine.
The
information in this prospectus is not complete and may be changed. The selling
stockholders may not sell these securities until the registration statement
filed with the Securities and Exchange Commission is effective. This prospectus
is not an offer to sell these securities, and the selling stockholders are
not
soliciting offers to buy these securities, in any state where the offer or
sale
of these securities is not permitted.
Subject
to completion dated June 3, 2008
PROSPECTUS
6,888,413
shares of common stock
NOVELOS
THERAPEUTICS, INC.
____________________
This
prospectus relates to the resale, from time to time, of up to 6,888,413 shares
of our common stock by the stockholders referred to throughout this prospectus
as “selling stockholders.” The shares of our common stock offered in this
prospectus are issuable on exercise of warrants.
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 June 2,
2008, the last reported sale price of our common stock on the OTC Electronic
Bulletin Board was $0.60 per share.
____________________
Investing
in our common stock involves a high degree of risk.
See
risk factors beginning on page 4 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 June [ ], 2008
TABLE
OF CONTENTS
|
Page
|
|
|
PROSPECTUS
SUMMARY
|
6
|
|
RISK
FACTORS
|
8
|
|
FORWARD-LOOKING
STATEMENTS
|
17
|
|
USE
OF PROCEEDS
|
18
|
|
MARKET
FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
|
19
|
|
BUSINESS
|
19
|
|
SELLING
STOCKHOLDERS
|
27
|
|
DESCRIPTION
OF SECURITIES
|
32
|
|
PLAN
OF DISTRIBUTION
|
36
|
|
DISCLOSURE
OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT
LIABILITIES
|
37
|
|
WHERE
YOU CAN FIND MORE INFORMATION
|
37
|
|
LEGAL
MATTERS
|
38
|
|
EXPERTS
|
38
|
|
INFORMATION
INCORPORATED BY REFERENCE
|
39
|
|
PART
II. INFORMATION NOT REQUIRED IN PROSPECTUS
|
II-1
|
|
II-8
|
4
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.
5
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 4.
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 2005, we completed a
two-step reverse merger with Common Horizons, Inc., and its wholly-owned
subsidiary Nove Acquisition, Inc. Following the merger, the surviving company
was Novelos Therapeutics, Inc.
We
are a
biopharmaceutical 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. 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 a chemopotentiator. In May
2006, we finalized a Special Protocol Assessment (SPA) 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 improvement in median overall survival. We
commenced patient enrollment in November 2006 and reached our enrollment target
of 840 patients in March 2008.
NOV-002
is also being developed to treat chemotherapy-resistant ovarian cancer. In
a
U.S. Phase 2 chemotherapy-resistant ovarian cancer trial at Massachusetts
General Hospital and Dana-Farber Cancer Institute from July 2006 through March
2008, NOV-002 (plus carboplatin) slowed progression of the disease in 60% of
evaluable patients (9 out of 15 women). The median progression free survival
was
15.4 weeks, almost double the historical control of 8 weeks. Based on these
results, we plan to initiate a second phase 2 trial in platinum-resistant
ovarian cancer patients in early 2009.
NOV-002
is also being developed to treat early-stage breast cancer. These patients
are
often treated with chemotherapy to minimize surgical intervention. In June
2007
we commenced enrollment in a U.S. Phase 2 trial in order to evaluate the ability
of NOV-002 to enhance the effectiveness of such chemotherapy. The interim
efficacy target was achieved in May 2008, earlier than expected, and the trial
is moving into stage 2.
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 monotherapy for chronic hepatitis C was accepted by the FDA in April
2006. A U.S. Phase 1b trial in patients who previously failed treatment with
pegylated interferon plus ribavirin commenced in September 2006 and was
completed in December 2007. Based on the favorable safety data obtained from
this trial, we plan to initiate a longer duration proof-of-concept trial in
the
fourth quarter of 2008.
Our
intellectual property portfolio of issued patents includes five U.S. patents,
two European patents and one Japanese patent. Overall, we have filed more than
thirty patent applications worldwide, with coverage including composition of
matter, method of use and manufacturing. The breadth of our intellectual
property will also allow us to expand our product pipeline by claiming and
commercializing additional compounds that are based on oxidized glutathione.
The
Offering
|
Securities
Offered:
|
6,888,413
shares of our common stock issuable upon exercise of warrants
|
|
Use
of Proceeds:
|
We
will not receive any of the proceeds from the sale by any selling
stockholder of common 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 June 2, 2008:
|
39,360,272
|
6
Summary
Financial Information
The
following table provides selected financial and operating data for the periods
indicated:
|
Three Months Ended
March 31,
|
Year Ended
December 31,
|
||||||||||||
|
2008
|
2007
|
2007
|
2006
|
||||||||||
|
Revenue
|
$
|
8,333
|
$
|
−
|
$
|
−
|
$
|
−
|
|||||
|
Costs
and expenses
|
7,175,000
|
2,517,129
|
20,294,187
|
8,929,808
|
|||||||||
|
Other
income (expense)
|
65,570
|
135,459
|
737,052
|
643,752
|
|||||||||
|
Net
loss
|
(7,101,097
|
)
|
(2,381,670
|
)
|
(19,557,135
|
)
|
(8,286,056
|
)
|
|||||
|
Net
loss attributable to common stockholders
|
(7,503,877
|
)
|
(2,446,950
|
)
|
(29,721,338
|
)
|
(8,547,176
|
)
|
|||||
|
Current
assets
|
6,658,010
|
9,598,161
|
11,059,501
|
11,888,674
|
|||||||||
|
Current
liabilities
|
9,623,533
|
1,307,165
|
7,059,390
|
1,313,425
|
|||||||||
|
Total
assets
|
|
6,714,949
|
9,632,695
|
11,107,660
|
11,923,359
|
||||||||
____________________
Our
principal executive offices are located at One Gateway Center, Suite 504,
Newton, Massachusetts 02458 and our telephone number is (617)
244-1616.
7
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
The
report from our independent registered public accounting firm included in our
annual report on Form 10-KSB indicates that there is substantial doubt about
whether we will be able to continue as a going concern for a period of one
year
from the date of their report.
The
report from our independent registered public accounting firm included with
our
annual report on Form 10-KSB indicates that factors exist that raise substantial
doubt about our ability to continue as a going concern through March 2009.
We
have estimated that the cash on hand at March 31, 2008 plus the proceeds from
the sale of Series D Preferred Stock will fund our obligations into late 2008.
Our ability to continue as a going concern is dependent on our ability to obtain
capital (through the sale of equity and debt securities and through
collaborative arrangements with partners) to fund our development activities.
If
we are unable to obtain additional capital through these sources, we may have
to
seek other sources of capital or reevaluate our operating plans, including
slowing or stopping the Phase 3 clinical development of our lead drug candidate,
NOV-002.
We
may have difficulty raising needed capital because of our limited operating
history and our business risks.
We
currently generate insignificant 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 late 2008, 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.
8
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 Practices capable
of
potential scale-up.
|
The
timeframe 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.
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.
9
We
may
encounter delays or rejections based on 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 monotherapy 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 trial of NOV-002 involving 44 non-small cell
lung
cancer patients provided what we believe to be a favorable outcome. As a result,
we enrolled the first patient in the pivotal Phase 3 trial of NOV-002 for
non-small cell lung cancer in November 2006. We reached our enrollment target
in
March 2008 and we expect trial conclusion mid-2009. We enrolled the first
patient in the Phase 2 clinical study for NOV-002 for chemotherapy-resistant
ovarian cancer in July 2006 and announced what we believe to be encouraging
results from this ongoing study in March 2008. We also commenced a Phase 2
clinical study for NOV-002 for early-stage breast cancer, and achieved an
interim efficacy target in May 2008, earlier than expected. In December 2007,
we
concluded a U.S. Phase 1b clinical trial of NOV-205 for chronic hepatitis C
non-responders based on favorable safety profile. 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.
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 on our ability, alone
or
with others, to complete the development of, obtain required regulatory
approvals for 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.
10
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 our 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 alternate research, development and/or 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 expose 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.
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.
11
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, on 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 on 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 on 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
|
|
·
|
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.
12
We
also
rely on 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 on 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 risks 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.
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 adequately market our products
|
|
·
|
fail
to satisfy financial or contractual obligations to
us;
|
|
·
|
offer,
design, manufacture or promote competing products ;
or
|
13
|
·
|
cease
operations with little or no
notice.
|
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 both Western and Eastern
Europe. We anticipate that approximately 40% of the remaining Phase 3 clinical
trial budget of approximately $12 million will be incurred in Euros. 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.
The
market for our products is rapidly changing and competitive, and new
therapeutics, new drugs and new treatments that 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. Most 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, serves as a vehicle to hold certain technology for possible future
exploration, and has 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 from 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.
14
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
healthcare reform, the cost of prescription pharmaceuticals and 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 (HMOs).
Third-party payers are increasingly challenging the prices charged for medical
drugs and services. Also, the trend toward managed health care in the United
States and the concurrent growth of organizations such as HMOs that 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 healthcare payers and providers
are instituting and the effect of any healthcare reform could materially harm
our ability to operate profitably.
We
depend on 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 on 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. Beginning with the annual report for the fiscal year ending December
31, 2007 we were required to include a report of our management on internal
control over financial reporting. In our annual report for the fiscal year
ending December 31, 2009 we will be required to include an attestation report
of
our independent registered public accounting firm on internal control over
financial reporting.
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:
15
|
·
|
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 D or Series C 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 biopharmaceutical 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.
In
2005
we 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 difficult to dispose of or to obtain
accurate quotations as to the market value of our common stock, and our common
stock may be less attractive for margin loans, for investment by financial
institutions, as consideration in future capital raising transactions or other
purposes.
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 holders of our Series D preferred stock beneficially
own, in the aggregate, approximately 51% of our outstanding voting shares.
The
interests of our current officers, directors and Series D investors may differ
from the interests of other stockholders. Further, our current officers,
directors and Series D investors 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 completion of 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.
|
16
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 convertible
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 shares of common stock reserved for
issuance upon the conversion and exercise of these securities and may increase
the shares reserved for these purposes in the future. 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
are prohibited from taking certain actions and entering into certain
transactions as a result of the issuance of our Series D preferred stock.
For
as
long as any shares of Series D Preferred Stock remain outstanding we are
prohibited from taking certain actions or entering into certain transactions
without the prior consent of the holders of outstanding shares of Series D
preferred stock. We are prohibited from paying dividends to common stockholders,
amending our certificate of incorporation, issuing any equity security or any
security convertible into or exercisable for any equity security at a price
of
$0.65 or less or with rights senior to the Series D Preferred Stock (except
for
certain exempted issuances), increasing the number of shares of Series D
Preferred Stock or issuing any additional shares of Series D Preferred Stock
other than the 420 shares designated in the Series D Certificate of
Designations, or changing the number of our directors. We are also prohibited
from entering into certain transactions such as selling or otherwise disposing
of all or substantially all of our assets or intellectual property or entering
into a merger or consolidation with another company unless we are the surviving
corporation, the Series D Preferred Stock remains outstanding and there are
no
changes to the rights and preferences of the Series D Preferred Stock, redeeming
or repurchasing any capital stock other than Series D Preferred Stock, or
incurring any new debt for borrowed money in excess of $500,000.
If
the
board of directors determines that any of these actions are in the best interest
of the Company or our shareholders, we may be unable to complete them if we
do
not get the approval of the holders of the outstanding shares of Series D
preferred stock.
We
were unable to pay dividends to our preferred stockholders on March 31, 2008
and
may be unable to pay dividends to preferred stockholders when due in future
periods.
As
a
result of continuing losses during the year ended December 31, 2007 and the
quarter ended March 31, 2008, as of March 31, 2008, we did not have legally
available funds for the payment of dividends under Delaware corporate law.
Accordingly, we were unable to pay dividends that were due to our Series B
and
Series C preferred stockholders as of that date. The dividends were paid
following the closing of our Series D financing, at which time we had funds
legally available for the payment of such dividends. Our ability to pay
dividends on stated future dividend payment dates will be dependent on a number
of factors including the timing of future financings and the amount of net
losses in future periods.
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.
17
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.
18
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 14, 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 2006
|
High
|
Low
|
|||||
|
First
Quarter
|
$
|
2.25
|
$
|
1.60
|
|||
|
Second
Quarter
|
1.95
|
0.85
|
|||||
|
Third
Quarter
|
1.05
|
0.63
|
|||||
|
Fourth
Quarter
|
1.02
|
0.60
|
|||||
|
Fiscal
Year 2007
|
High
|
Low
|
|||||
|
First
Quarter
|
$
|
1.24
|
$
|
0.85
|
|||
|
Second
Quarter
|
1.40
|
0.82
|
|||||
|
Third
Quarter
|
0.90
|
0.45
|
|||||
|
Fourth
Quarter
|
0.67
|
0.43
|
|||||
|
Fiscal
Year 2008
|
High
|
Low
|
|||||
|
First
Quarter
|
$
|
0.82
|
$
|
0.43
|
|||
|
Second
Quarter (through June 2, 2008)
|
0.64
|
0.44
|
|||||
On
June
2, 2008 there were 112 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
are prohibited from paying any dividends on common stock as long as any shares
of our Series D preferred stock are outstanding. We currently expect to retain
future earnings, if any, for the development of our business.
Our
transfer agent and registrar is American Stock Transfer and Trust Company,
59
Maiden Lane, New York, NY 10038.
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 2005, we completed a
two-step reverse merger with Common Horizons, Inc., and its wholly-owned
subsidiary Nove Acquisition, Inc. Following the merger, the surviving company
was Novelos Therapeutics, Inc.
We
are a
biopharmaceutical 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. 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 a chemopotentiator. In May
2006, we finalized a Special Protocol Assessment (SPA) 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 improvement in median overall survival. We
commenced patient enrollment in November 2006 and reached our enrollment target
of 840 patients in March 2008.
19
NOV-002
is also being developed to treat chemotherapy-resistant ovarian cancer. In
a
U.S. Phase 2 chemothereapy-resistant ovarian cancer trial at Massachusetts
General Hospital and Dana-Farber Cancer Institute from July 2006 through March
2008, NOV-002 (plus carboplatin) slowed disease progression in 60% of evaluable
patients (9 out of 15 women). The median progression free survival was 15.4
weeks, almost double the historical control of 8 weeks. Based on these results,
we plan to initiate a second phase 2 trial in platinum-resistant ovarian cancer
patients in early 2009.
NOV-002
is also being developed to treat early-stage breast cancer. These patients
are
often treated with chemotherapy to minimize surgical intervention. In June
2007
we commenced enrollment in a U.S. Phase 2 trial in order to evaluate the ability
of NOV-002 to enhance the effectiveness of such chemotherapy while diminishing
dose-limiting side-effects. As of May 2008, 16 women have been enrolled with
four pathologic complete responses demonstrated in the first eight women that
have both completed chemotherapy and undergone surgery. Furthermore, NOV-002
was
associated with decreased hematologic toxicities and with decreased use of
growth factors relative to historical experience. Detailed results will be
submitted for presentation at the San Antonio Breast Cancer Symposium in
December 2008. Full enrollment of 46 patients is expected mid-2009, with trial
conclusion in early 2010.
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 monotherapy for chronic hepatitis C was accepted by the FDA in April
2006. A U.S. Phase 1b trial in patients who previously failed treatment with
pegylated interferon plus ribavirin commenced in September 2006 and was
completed in December 2007. Based on the favorable safety data obtained from
this trial, we plan to initiate a longer duration proof-of-concept trial in
the
second half of 2008.
Our
intellectual property portfolio of issued patents includes five U.S. patents,
two European patents and one Japanese patent. Overall, we have filed more than
thirty patent applications worldwide, with coverage including composition of
matter, method of use and manufacturing. The breadth of our intellectual
property will also allow us to expand our product pipeline by claiming and
commercializing additional compounds that are based on oxidized glutathione.
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. and Europe, has
demonstrated an excellent safety and efficacy profile in Russia as a combination
treatment with chemotherapy for many different cancers. The Russian data is
particularly compelling in non-small cell lung cancer and platinum-resistant
ovarian cancer, indications with large and growing unmet medical needs. In
a
1996-1998 Russian non-small cell lung cancer trial, NOV-002 increased the
one-year survival rate from 17% to 63% (p<0.01) 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. Positive results
in
a controlled U.S-based Phase 1/2 non-small cell lung cancer study completed
in
August 2005 reinforced the positive results obtained in earlier Russian clinical
studies.
We
intend
to obtain a U.S marketing partner for NOV-002 after the non-small cell lung
cancer Phase 3 clinical trial results are available (expected mid-2009). In
the
nearer term, we plan to out-license NOV-002 in Europe and/or Japan and use
resources from these potential arrangements to offset, in part, the expense
of
our development. In December 2007, we entered into a collaboration agreement
with Lee’s Pharmaceutical (HK) Ltd (which is 30% owned by Sigma-Tau Group) to
develop, manufacture and commercialize NOV-002 for cancer and NOV-205 for
hepatitis in Hong Kong, Macau, China and Taiwan.
In
Russian clinical studies, NOV-205 has demonstrated the ability to substantially
decrease the serum 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. In December 2007, based on a favorable safety profile, we concluded
a
U.S. Phase 1b clinical trial in chronic hepatitis C non-responders. We plan
to
commence a proof-of-concept trial in the second half of 2008 and will explore
out-license opportunities for NOV-205 after completion of this trial.
20
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 NOV-205, 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.
Protein
S-glutathionylation attendant to cellular redox changes at the cell surface
and
intracellularly are known to affect a variety of critical cell functions
including:
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Cell
signaling pathways
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·
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Cytoskeletal
structure/function
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·
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Protein
folding/stability
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·
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Calcium
homeostasis
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Energy
metabolism
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Redox
homeostasis
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In
addition, changes in the ratio of reduced to oxidized forms of glutathione
(GSH/GSSG) can modulate protein phosphorylation in signal pathways, further
amplifying the impact of redox changes on cell function. Examples of
redox-sensitive 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. The activities of other
immune/inflammation regulatory proteins are also sensitive to GSH/GSSG (e.g.,
mitogen-activated protein kinases, MAPKs) as are elements of the cytoskeleton
(e.g., actin) that control interaction and communication between the cells
and
their surrounding environment (e.g., extracellular matrix) and cell surface
proteins (e.g., protein disulfide isomerase, PDI), which have been implicated
in
the modulation of tumor cell invasiveness and metastasis.
Importantly,
it has been shown that oxidized glutathione itself is capable of causing protein
glutathionylation leading to changes in cell signaling pathway function. Thus,
GSSG, or NOV-002, added to cells can result in a rapid, transient alteration
of
cell surface or intracellular redox state by shifting the equilibrium towards
the formation of mixed disulfides with protein thiols. This is accompanied
by
glutathionylation of cellular proteins and alterations in phosphorylation of
signaling proteins (e.g., MAPKs, AKT, JAK2, STAT5).
Findings
with NOV-002 and NOV-205 in animals and humans are consistent with a variety
of
known effects of modulating cellular redox status (e.g., blood precursor cell
proliferation (hematopoiesis), modulation of cytokine and growth factor
production - including those known to control production of blood cells, immune
system modulation, cytoskeletal alterations that may impact the migration and
invasiveness of tumor cells. Identification of the precise molecular targets
of
the GSSG component of NOV-002 and NOV-205, which account for their 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 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.
NOV-002
NOV-002
is an injectable, small-molecule formulation of a natural metabolite that is
being developed to be used in combination with chemotherapy for treatment of
lung, ovarian and breast cancer.
21
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 with Fast Track designation. 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 across numerous types of cancer including:
non-small cell lung cancer, breast cancer, ovarian cancer, colorectal cancer
and
pancreatic cancer. Since the Russian Ministry of Health approval in 1998, it
is
estimated that NOV-002 has been administered to over 10,000 patients.
According
to the American Cancer Society, about 1.44 million U.S. men and women were
expected to be diagnosed with cancer in 2007. Over 550,000 U.S. cancer patients
were expected to die in 2007, 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. Approximately 213,000 people
were expected to be diagnosed with lung cancer in 2007, with over 160,000
deaths. According to a Rodman and Renshaw report dated December 2006, there
are
approximately 405,000 cases of lung cancer among industrial nations and the
pharmaceutical market for treating lung cancer is currently approximately $800
million per year in the U.S. and $1.8 billion worldwide, expected to grow to
greater than $8 billion by 2011. 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 as recently as 2005, the one-year
survival rate for first-line therapy is typically only about 35%, median
survival is approximately 8.5 months and the objective tumor response rate
is
about 20%. Overall, fewer than 5% of advanced non-small cell lung cancer
patients survive five years. Docetaxel is approved for use as second-line
treatment of non-small cell lung cancer. New dosing regimens with existing
cytotoxic drugs are likely to provide only incremental improvements in efficacy
and/or safety, and are very expensive. Similarly, emerging targeted biologic
therapies, such as Astra Zeneca’s IRESSA®, OSI’s TARCEVA®, Genentech’s AVASTIN®
and ImClone’s ERBITUX®, may offer some benefit for certain patient
subpopulations, but overall efficacy has remained low. Moreover, there are
significant safety concerns and the costs to manufacture are very high. Thus,
there is an absence of effective treatments for non-small cell lung cancer,
particularly for late stage patients.
NOV-002
can be distinguished from other drugs for non-small cell lung cancer on the
market or in development because, based on available data, NOV-002 possesses
the
key attributes of safety, improved recovery from chemotherapy toxicity,
potentiation of chemotherapy (increased survival rates and better anti-tumor
effects) and low cost of manufacture. In a controlled randomized U.S. Phase
1/2
clinical trial, advanced NSCLC patients treated with NOV-002 in combination
with
paclitaxel and carboplatin demonstrated improved objective tumor response (69%
of the patients treated with NOV-002 plus chemotherapy had 50% or greater tumor
shrinkage versus only 33% of the patients treated with chemotherapy alone,
p<0.05) and higher tolerance of chemotherapy versus the control group
(p<0.01). In a controlled randomized Russian trial, when used in combination
with cisplatin-based chemotherapy, NOV-002 increased the one-year survival
of
advanced non-small cell lung cancer patients from 17% to 63%, p<0.01 (versus
35% typical in the U.S.). On the basis of U.S. and Russian data, 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 have utility in all stages of non-small
cell lung cancer and in other solid tumor types as well.
The
Russian non-clinical 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. We finalized a Special Protocol Assessment with the FDA in May 2006
for a
single pivotal Phase 3 trial in advanced non-small cell lung cancer in
combination with first-line chemotherapy, and obtained Fast Track designation
in
August 2006. The primary endpoint of this trial is improvement in median overall
survival and we reached our enrollment target of 840 patients in March 2008.
We
expect the pivotal Phase 3 trial to conclude in mid-2009.
22
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 (patients who had not
received prior chemotherapy) were randomized to one of three groups for six
months of treatment:
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Group
A: NOV-002, administered intravenously and intramuscularly, in combination
with cytotoxic chemotherapy (carboplatin +
paclitaxel).
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Group
B: NOV-002, administered intravenously and subcutaneously, in combination
with cytotoxic chemotherapy.
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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
more than ten years ago to evaluate the safety and efficacy of NOV-002 in
patients with advanced non-small cell lung cancer. NOV-002, used in combination
with chemotherapy, dramatically and significantly increased the one-year
survival rate (63% treated group vs. 17% control, p<0.01). 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. As in the U.S. Phase
1/2 trial, patients receiving NOV-002 were able to receive significantly more
cycles of chemotherapy. 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 in 2000, 52% of the patients treated
with NOV-002 survived for at least one year.
NOV-002
for Chemotherapy (Platinum)-Resistant Ovarian Cancer
According
to the American Cancer Society, approximately 22,000 U.S. women were expected
to
be diagnosed with ovarian cancer in 2007 and 15,000 women are expected to die
from it. According to a Rodman and Renshaw report dated December 2006, the
pharmaceutical market for treating ovarian cancer is estimated to be $300
million per year. There is a lack of effective treatment, particularly in the
case of patients who are chemotherapy refractory (those who do not respond
to
chemotherapy) or resistant (those who relapse shortly after receiving
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 in combination. Doxorubicin and topotecan alternate
as second- and third-line chemotherapy treatments.
Refractory/resistant
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 an
article by A. Berkenblit in the June 2005 issue of the Journal
of Reproductive Medicine.
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 is much higher than would
be expected in such patients. 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.
23
In
a U.S.
Phase 2 chemothereapy-resistant ovarian cancer trial at Massachusetts General
Hospital and Dana-Farber Cancer Institute from July 2006 through March 2008,
NOV-002 (plus carboplatin) slowed progression of the disease in 60% of evaluable
patients (9 out of 15 women). The median progression free survival was 15.4
weeks, almost double the historical control of 8 weeks. Based on these results,
we plan to initiate a second phase 2 trial in chemotherapy-resistant ovarian
cancer patients in early 2009.
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
surgical intervention. A U.S. Phase 2 trial to evaluate the ability of NOV-002
to enhance the effectiveness of such chemotherapy while diminishing side-effects
commenced in June 2007 at the Medical University of South Carolina (MUSC)
Hollings Cancer Center. Alberto Montero, MD, Assistant Professor of Medicine,
Division of Hematology-Oncology, is the Principal Investigator.
Breast
cancer remains a serious public health concern throughout the world. According
to American Cancer Society, approximately 180,000 women in the US were expected
to be diagnosed with breast cancer in 2007, and approximately 40,000 were
expected to die from the disease. Neoadjuvant or preoperative systemic
chemotherapy is commonly employed in patients with locally advanced stage III
breast cancer and in some patients with stage II tumors. Administration of
neoadjuvant chemotherapy reduces tumor size, thus enabling breast conservation
surgery in patients who otherwise would require a mastectomy. Furthermore,
several studies have shown that pCR following neoadjuvant chemotherapy is
associated with a significantly higher probability of long-term survival.
However, only a minority of patients with HER-2/neu negative breast cancer
achieve a pCR with standard chemotherapy.
The
primary objective of this open-label, single-arm trial is to determine if
preoperative administration of NOV-002 in combination with eight cycles of
chemotherapy (four of doxorubicin and cyclophosphamide followed by four of
docetaxel) results in an appreciably higher pathologic complete response (pCR)
rate than expected with this same chemotherapeutic regimen alone. According
to
the Simon two-stage trial design, if four or more pCRs were observed in the
first stage of the trial (19 women), enrollment would continue into the second
stage, for a total of 46 women.
To
date,
16 women have been enrolled with four pCRs already demonstrated in the first
eight women that have both completed chemotherapy and undergone surgery.
Furthermore, NOV-002 was associated with decreased hematologic toxicities and
with decreased use of growth factors relative to historical experience. Detailed
results will be submitted for presentation at the San Antonio Breast Cancer
Symposium in December 2008. Having achieved an interim efficacy target, even
earlier than expected, the trial is moving into the second stage. Full
enrollment of 46 patients is expected mid-2009, with trial conclusion in early
2010.
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 a September 2006 publication of Nature
Reviews Drug Discovery
the
current global market is believed to be in excess of $3 billion per year,
growing to more than $8 billion by 2010. 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.
24
NOV-205
was approved in Russia by the Ministry of Health in 2001 as monotherapy 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 serum 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,
we
filed an Investigational New Drug Application with the FDA for NOV-205 as
monotherapy 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 and was completed in December 2007. Based
on the favorable safety data obtained from this trial, we expect to initiate
a
longer duration proof-of-concept trial in the second half of 2008.
Non-clinical
Research Program
Our
non-clinical 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 and a stockholder. 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. Funded research collaborations are
also
underway at other academic/scientific institutions including
Harvard/Massachusetts General Hospital, the Wistar Institute and the University
of Massachusetts Medical Center to further elaborate in
vitro
and
in
vivo
mechanisms of drug action that may underlie the clinical therapeutic profiles
of
NOV-002 and NOV-205.
Manufacturing
Our
proprietary manufacturing process is well-established, simple, inexpensive
and
scalable. We have used U.S. and Canadian contract manufacturing facilities
that
are registered with the FDA 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 Practices 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 (vials containing the active
pharmaceutical ingredient and solution) has successfully completed 36-month
stability studies.
25
Similar
to NOV-002, NOV-205’s active pharmaceutical ingredient is manufactured in
compliance with current Good Manufacturing Practices 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 five issued patents in the U.S. We also have two issued patents in Europe
and one in Japan. Overall, we have filed more than 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 May
1, 2008 we have twelve employees, ten 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.
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, recordkeeping,
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:
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Pre-clinical
laboratory tests, in
vivo
pre-clinical studies, and formulation
studies;
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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;
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Adequate
and well controlled human clinical trials to establish the safety
and
efficacy of the product;
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·
|
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.
26
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 office in Newton, Massachusetts. Our office consists of
approximately 3,000 square feet and is rented for approximately $7,700 per
month. This lease expires in August 2009. 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.
SELLING
STOCKHOLDERS
6,888,413
shares of common stock 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, to the selling stockholders on May 27, 2005, June 29, 2005, July 29,
2005
and August 9, 2005 (the “Private Placement”). We sold an aggregate of 200 units
in the Private Placement. Holders of our convertible debt in the amount of
$550,000 converted the debt and interest into 22 of the 200 units. We issued
a
total of 4,000,000 shares of common stock and three-year warrants to purchase
a
total of 2,000,000 shares of common stock (the “Warrants”) to the investors in
the Private Placement. We received gross proceeds of $4,450,000 and net cash
proceeds of $3,715,000 (after deducting finders’ fees and transaction costs)
from the Private Placement.
The
selling stockholders listed in the table below are offering up to 6,888,413
shares of our common stock issuable upon exercise of the Warrants. When
originally issued the total number of shares of common stock issuable upon
exercise of the Warrants was 2,000,000 (at an exercise price of $2.25 per
share). However, as a result of our subsequent sales of equity securities (most
recently in April 2008) the aggregate number of shares of common stock issuable
upon exercise has increased to 6,888,413 and the exercise price has decreased
to
$0.65 per share. None of the Warrants have been exercised and all expire on
August 9, 2008. The registration statement, of which this prospectus is a part,
is being filed pursuant to the terms of our registration rights agreements
with
these investors.
Registration
Rights
In
accordance with registration rights granted to the investors in the Private
Placement, we filed a Registration Statement on Form SB-2 (Reg. No. 333-129744)
on November 16, 2005 (the “Original Registration Statement”) registering, among
other shares of common stock and common stock issuable upon conversion of
preferred stock, all the shares of common stock issued in the Private Placement
and 2,727,200 shares of common stock issuable upon exercise of the Warrants.
The
Original Registration Statement was declared effective on December 15, 2005.
On
November 17, 2006 we filed Post-Effective Amendment No. 2 to the Original
Registration Statement on Form SB-2 (Reg. No. 333-133043) which was a combined
registration statement which also constituted Post-Effective Amendment No.
1 to
another registration statement that we filed on April 6, 2006 (the “Combined
Registration Statement”). The aggregate number of shares of common stock covered
by the Combined Registration Statement was 34,285,449, including the 2,727,200
shares of common stock issuable upon exercise of the Warrants. The Combined
Registration Statement was declared effective on November 21, 2006.
27
Our
obligation to maintain an effective registration statement as to the shares
of
common stock issued in the Private Placement expired in August 2007. Similarly,
our obligation to maintain an effective registration statement as to the other
shares of common stock and common stock issuable upon exercise of warrants
or
conversion of preferred stock included in the Combined Registration Statement
expired in March 2008. As a result of the expiration of these obligations,
we
filed on May 22, 2008, a post-effective amendment to the Combined Registration
Statement to deregister all such shares that were registered pursuant to the
Combined Registration Statement but had not been sold thereunder.
We
also
deregistered the 2,727,200 shares of common stock issuable upon exercise of
the
Warrants since we could not, in a post-effective amendment, increase the number
of shares of common stock being registered as necessitated by the increase
in
the number of shares of common stock issuable upon exercise of the Warrants.
However, we remain obligated to keep the shares of common stock issuable upon
exercise of the Warrants registered until all such shares have been sold or
may
be sold without volume restrictions under Rule 144. This obligation is the
reason for the filing of this registration statement.
We
are
filing this registration statement to register the 2,727,200 shares of common
stock issuable upon exercise of the Warrants that were previously included
under
the Combined Registration Statement and to register an additional 4,161,213
shares of common stock that are now issuable upon exercise of the Warrants
as a
result of anti-dilution adjustments in connection with our subsequent sales
of
equity securities (most recently in April 2008). Such adjustments increased
the
number of shares of common stock issuable upon exercise of the Warrants to
6,888,413.
The
Warrants expire on August 9, 2008 if they are not exercised. Upon the expiration
of the Warrants we will no longer have any obligation to keep this registration
statement effective (or in the event the Warrants are exercised prior to August
9, 2008 we will be obligated to keep this registration statement effective
for a
period of six months at which time the shares of common stock issued upon
exercise of the Warrants will be eligible to be sold without volume restrictions
under Rule 144).
Relationships
with Selling Stockholders
On
September 30, 2005 and October 3, 2005 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 to Longview Fund LP and two of its affiliates and
Sunrise Equity Partners L.P.
We also
entered into a registration rights agreement with Longview Fund LP and Sunrise
Equity Partners L.P. to register the shares of common stock issuable upon
conversion of the Series A preferred stock and exercise of the warrants. Those
shares were registered on the Original Registration Statement and the Combined
Registration Statement until we deregistered them on May 22, 2008 pursuant
to
the Post-Effective Amendment No. 3 to the Combined Registration Statement.
On
May 2,
2007, we sold 1,500 shares of our Series B convertible preferred stock and
issued warrants to purchase 7,500,000 shares of our common stock to certain
accredited investors for an aggregate purchase price of $15,000,000. As a
condition to closing the Series B preferred stock and warrant financing, the
holders of our Series A preferred stock, including Longview Fund LP and Sunrise
Equity Partners L.P., exchanged all 3,264 shares of their Series A preferred
stock for 272 shares of a new Series C convertible preferred stock, the rights
and preferences of which are junior to the Series B preferred stock. As an
inducement for the holders of the Series A preferred stock to exchange their
shares, we issued warrants to purchase 1,333,333 shares of our common stock
and
paid them a cash allowance to defray expenses totaling $40,000 and an amount
equal to unpaid dividends accumulated on the Series A preferred stock through
the date of the exchange.
Selling
Stockholders Table
The
following table sets forth, to the best of our knowledge, the approximate number
of shares beneficially owned as of May 12, 2008 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 May 12, 2008. The “Shares
Offered” column reflects all of the shares that each selling stockholder may
offer under this prospectus. Percentage ownership is based on 39,360,272 shares
issued and outstanding as of May 12, 2008. The table assumes that the selling
stockholders sell all of the shares.
We
prepared the table below based on our records and information supplied to us
by
the selling stockholders and other available information. 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.
28
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, provided however that this limitation may be revoked
by the stockholder upon 61 days prior notice to the Company.
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.
Except
as
described above in “Relationships with Selling Stockholders” or in the footnotes
to the selling stockholders table and 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
|
|||||||||||||||
|
Anthony
Abenante
|
20,000
|
34,615
|
54,615
|
34,615
|
20,000
|
0
|
*
|
|||||||||||||||
|
ALE
Industries- Albert Jacobs
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Alpha
Capital AG
|
129,322
|
596,923
|
(3)
|
726,245
|
276,923
|
129,322
|
320,000
|
1.1
|
%
|
|||||||||||||
|
John
Wayne Andrews
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Sergey
Babchin
|
771,229
|
69,230
|
840,459
|
69,230
|
771,229
|
0
|
2.0
|
%
|
||||||||||||||
|
John
Barnhardt
|
0
|
69,230
|
69,230
|
69,230
|
0
|
0
|
*
|
|||||||||||||||
|
Jerome
Belson
|
0
|
173,076
|
173,076
|
173,076
|
0
|
0
|
*
|
|||||||||||||||
|
Andrey
Beltov
|
795,871
|
69,230
|
865,101
|
69,230
|
795,871
|
0
|
2.0
|
%
|
||||||||||||||
|
Walter
Bernheimer
|
110,000
|
34,615
|
144,615
|
34,615
|
110,000
|
0
|
*
|
|||||||||||||||
|
Family
Ltd. Partnership Bernheimer
|
50,000
|
34,615
|
84,615
|
34,615
|
50,000
|
0
|
*
|
|||||||||||||||
|
Harvey
Blitz
|
60,000
|
69,230
|
129,230
|
69,230
|
60,000
|
0
|
*
|
|||||||||||||||
|
Erno
Bodek
|
185,000
|
276,923
|
461,923
|
276,923
|
185,000
|
0
|
*
|
|||||||||||||||
|
Gerald
Brauser
|
290,000
|
519,230
|
809,230
|
519,230
|
290,000
|
0
|
*
|
|||||||||||||||
|
Richard
J. & Joan M. Brown
|
0
|
69,230
|
69,230
|
69,230
|
0
|
0
|
*
|
|||||||||||||||
|
Allen
O. & Jolaine Cage
|
40,000
|
103,846
|
143,846
|
103,846
|
40,000
|
0
|
*
|
|||||||||||||||
|
Camden
International
|
5,000
|
298,461
|
(3)
|
303,461
|
138,461
|
5,000
|
160,000
|
*
|
||||||||||||||
|
Ron
Cater
|
30,000
|
34,615
|
64,615
|
34,615
|
30,000
|
0
|
*
|
|||||||||||||||
|
Margie
Chassman
|
9,100
|
138,460
|
147,560
|
138,460
|
9,100
|
0
|
*
|
|||||||||||||||
|
Simon
Clarke
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Leonard
Cohen
|
20,000
|
69,230
|
89,230
|
69,230
|
20,000
|
0
|
*
|
|||||||||||||||
|
Frank
A. & Carol A. Consolati
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Harold
E. & Connie L. Crowley
|
0
|
69,230
|
69,230
|
69,230
|
0
|
0
|
*
|
|||||||||||||||
|
Peter
D’Arienzo
|
30,000
|
34,615
|
64,615
|
34,615
|
30,000
|
0
|
*
|
|||||||||||||||
|
Frank
DeCarolis
|
95,000
|
34,615
|
129,615
|
34,615
|
95,000
|
0
|
*
|
|||||||||||||||
|
Ulrich
Eilers
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Richard
G. & Kenneth S. Etra
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Chris
Everest IRA
|
20,000
|
34,615
|
54,615
|
34,615
|
20,000
|
0
|
*
|
|||||||||||||||
|
Frank
Fila
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Anthony
J. Fortunato
|
413,595
|
34,615
|
448,210
|
34,615
|
413,595
|
0
|
1.1
|
%
|
29
|
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
|
|||||||||||||||
|
Eugene
Fridman
|
32,122
|
34,615
|
66,737
|
34,615
|
32,122
|
0
|
*
|
|||||||||||||||
|
Boris
Friedberg
|
40,000
|
69,230
|
109,230
|
69,230
|
40,000
|
0
|
*
|
|||||||||||||||
|
Vitaliy
Gassel
|
30,498
|
20,769
|
51,267
|
20,769
|
30,498
|
0
|
*
|
|||||||||||||||
|
Joseph
Giamanco
|
0
|
276,922
|
276,922
|
276,922
|
0
|
0
|
*
|
|||||||||||||||
|
A.
George Gitter, Trust C, GST Exempt
|
160,000
|
276,923
|
436,923
|
276,923
|
160,000
|
0
|
*
|
|||||||||||||||
|
Dennis
Glynn
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Anna
& Max Goldfarb
|
25,000
|
91,730
|
116,730
|
91,730
|
25,000
|
0
|
*
|
|||||||||||||||
|
Klatte
Golf, L.P.
|
80,000
|
138,461
|
218,461
|
138,461
|
80,000
|
0
|
*
|
|||||||||||||||
|
Mark
Stephen Goodman
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Herbert
A. & Lily A. Gordon
|
20,000
|
34,615
|
54,615
|
34,615
|
20,000
|
0
|
*
|
|||||||||||||||
|
Lawrence
Gould
|
20,000
|
34,615
|
54,615
|
34,615
|
20,000
|
0
|
*
|
|||||||||||||||
|
Russell
Green
|
25,750
|
55,722
|
(4)
|
81,472
|
34,615
|
25,750
|
21,107
|
*
|
||||||||||||||
|
James
D. & Karen J. Griffith
|
0
|
69,230
|
69,230
|
69,230
|
0
|
0
|
*
|
|||||||||||||||
|
Salvatore
Guerrera
|
0
|
69,230
|
69,230
|
69,230
|
0
|
0
|
*
|
|||||||||||||||
|
Stuart
Hanford
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Colin
J. & Gursharn K. Harvey
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Willie
Hines
|
23,000
|
34,615
|
57,615
|
34,615
|
23,000
|
0
|
*
|
|||||||||||||||
|
Jasuns
Holdings Ltd.
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Dr.
Vincent & Betty L. John
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Robert
& Margaret R. Kenwrick
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Gary
Kessler
|
20,000
|
34,615
|
54,615
|
34,615
|
20,000
|
0
|
*
|
|||||||||||||||
|
Michael
Koral
|
292,000
|
34,615
|
326,615
|
34,615
|
292,000
|
0
|
*
|
|||||||||||||||
|
Michael
Lane
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Richard
Lazarow
|
12,000
|
34,615
|
46,615
|
34,615
|
12,000
|
0
|
*
|
|||||||||||||||
|
Carlos
C. Lee
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Julian
Lender
|
16,000
|
27,692
|
43,692
|
27,692
|
16,000
|
0
|
*
|
|||||||||||||||
|
Stolpe
Family Limited Partnership
|
80,000
|
138,461
|
218,461
|
138,461
|
80,000
|
0
|
*
|
|||||||||||||||
|
Lev
Lisser
|
115,667
|
146,922
|
(4)
|
262,589
|
103,846
|
115,667
|
43,076
|
*
|
||||||||||||||
|
Anna
Lisser
|
22,500
|
34,615
|
57,115
|
34,615
|
22,500
|
0
|
*
|
|||||||||||||||
|
Keith
and Patricia Little, FLP.
|
40,000
|
69,230
|
109,230
|
69,230
|
40,000
|
0
|
*
|
|||||||||||||||
|
Mark
Livshitz
|
49,154
|
34,615
|
83,769
|
34,615
|
49,154
|
0
|
*
|
|||||||||||||||
|
Longview
Fund LP
|
0
|
5,025,547
|
(3)(5)
|
5,025,547
|
207,692
|
0
|
4,817,855
|
10.9
|
%
|
|||||||||||||
|
Chris
Marley
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Bruce
R. Mathias
|
20,000
|
106,153
|
(4)
|
126,153
|
69,230
|
20,000
|
36,923
|
*
|
||||||||||||||
|
Albert
Mazler
|
20,000
|
34,615
|
54,615
|
34,615
|
20,000
|
0
|
*
|
|||||||||||||||
|
Andrey
Mazo
|
32,690
|
33,526
|
(6)
|
66,216
|
32,884
|
32,690
|
642
|
*
|
||||||||||||||
|
Ronald
J. Menello
|
68,000
|
207,691
|
275,691
|
207,691
|
68,000
|
0
|
*
|
|||||||||||||||
|
Robert
Mynett
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Derek
Neesam
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Dennis
A. Noyes
|
20,000
|
34,615
|
54,615
|
34,615
|
20,000
|
0
|
*
|
|||||||||||||||
|
Francis
G. O’Connor
|
9,605
|
34,615
|
44,220
|
34,615
|
9,605
|
0
|
*
|
|||||||||||||||
|
Richard
Olson
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Brian
Oregan
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Gerald
Ortsman
|
24,700
|
34,615
|
59,315
|
34,615
|
24,700
|
0
|
*
|
|||||||||||||||
|
Rick
Perlmutter
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Lauren
Pozefsky, Irrevocable Trust
|
20,000
|
34,615
|
54,615
|
34,615
|
20,000
|
0
|
*
|
|||||||||||||||
|
Andrew
Richards
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Michael
H. Rock
|
0
|
69,230
|
69,230
|
69,230
|
0
|
0
|
*
|
|||||||||||||||
|
Joseph
Roda
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Dr.
Daniel Rosberger
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Joseph
C. Roselle (1)
|
40,000
|
69,230
|
109,230
|
69,230
|
40,000
|
0
|
*
|
30
|
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
|
|||||||||||||||
|
Philip
Rushby
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Albert
L. Saphier IRA
|
20,000
|
34,615
|
54,615
|
34,615
|
20,000
|
0
|
*
|
|||||||||||||||
|
SCG
Capital (1) (2)
|
0
|
69,230
|
69,230
|
69,230
|
0
|
0
|
*
|
|||||||||||||||
|
Adam
Schacter (1)(2)
|
17,500
|
34,615
|
52,115
|
34,615
|
17,500
|
0
|
*
|
|||||||||||||||
|
Irwin
Schacter (1)(2)
|
35,000
|
34,615
|
69,615
|
34,615
|
35,000
|
0
|
*
|
|||||||||||||||
|
Steve
Schnipper
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Guido
Schoeb
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Duncan
Scott
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Fred
B. & John Sheats & Molis, Joint Tenants
|
6,000
|
34,615
|
40,615
|
34,615
|
6,000
|
0
|
*
|
|||||||||||||||
|
Isaak
Shklyarov
|
40,000
|
69,230
|
109,230
|
69,230
|
40,000
|
0
|
*
|
|||||||||||||||
|
David
M. Solomon
|
130,000
|
69,230
|
199,230
|
69,230
|
130,000
|
0
|
*
|
|||||||||||||||
|
Alvin
& Sharon Spearman
|
17,500
|
34,615
|
52,115
|
34,615
|
17,500
|
0
|
*
|
|||||||||||||||
|
Nick
Stock
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Ira
Stollar
|
20,000
|
34,615
|
54,615
|
34,615
|
20,000
|
0
|
*
|
|||||||||||||||
|
David
Sukoff
|
113,750
|
34,615
|
148,365
|
34,615
|
113,750
|
0
|
*
|
|||||||||||||||
|
Sunrise
Equity Partners, L.P.
|
185,185
|
903,122
|
(7)
|
1,088,307
|
276,923
|
185,185
|
626,199
|
2.0
|
%
|
|||||||||||||
|
Richard
& Janet Sygar
|
70,000
|
34,615
|
104,615
|
34,615
|
70,000
|
0
|
*
|
|||||||||||||||
|
Certified
Systems
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Alan
& Sheena Taylor
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Andrew
Telford
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Owen
James Truelove
|
0
|
34,615
|
34,615
|
34,615
|
0
|
0
|
*
|
|||||||||||||||
|
Herbert
Weisberger
|
2,800
|
34,615
|
37,415
|
34,615
|
2,800
|
0
|
*
|
*
Less
than 1%
| (1) |
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.
|
| (2) |
The
selling securityholder has represented in its Selling Securityholder
Notice and Questionnaire that it/he is a
broker-dealer.
|
| (3) |
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.
|
| (4) |
Includes
shares of common stock issuable with respect to warrants paid as
a
finders’ fee in connection with our private placement transactions of
units: Russell Green 21,107 shares; Lev Lisser 43,076 shares; Bruce
Mathias 36,923 shares.
|
| (5) |
Includes
3,138,461 shares of common stock issuable upon the conversion of
Series C
convertible preferred stock and a total of 1,439,394 shares of common
stock issuable upon the exercise of warrants issued in connection
with the
sale of Series A convertible preferred stock and the subsequent exchange
of shares of Series A preferred stock for shares of Series C preferred
stock.
|
| (6) |
Shares
in the “Right to Acquire” column include all shares issuable upon exercise
of options that may be exercised within 60 days from May 12, 2008.
|
| (7) |
Includes
313,846 shares of common stock issuable upon the conversion of Series
C
convertible preferred stock, a total of 143,939 shares of common
stock
issued upon exercise of warrants issued in connection with the sale
of
Series A convertible preferred stock and the subsequent exchange
of shares
of Series A preferred stock for shares of Series C preferred stock
and 168,414 shares of common stock issuable upon exercise of warrants
issued in connection with a private placement during 2006.
|
31
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 investors, with us, or any of our predecessors or
affiliates, over the past three years. Certain 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
|
|
|
Keith
and Patricia Little, FLP
|
Keith
Little
|
|
|
Klatte
Golf, L.P.
|
Michael
Klatte
|
|
|
Longview
Fund LP
|
Peter
T. Benz
|
|
|
Lauren
Pozefsky, Irrevocable Trust
|
Abby
L. Pozefsky
|
|
|
SCG
Capital
|
Steven
Geduld
|
|
|
Sunrise
Equity Partners, L.P.
|
Marilyn
Adler, Nathan Low and Amnon
Mandelbaum
|
DESCRIPTION
OF SECURITIES
Under
our
amended and restated certificate of incorporation, our authorized capital stock
consists of 150,000,000 shares of common stock, $0.00001 par value per share
and
7,000 shares of preferred stock, $0.00001 par value per share.
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 April 11, 2008, we had designated 400 shares of
Series B convertible preferred stock, none of which were issued and outstanding
on that date; 272 shares of Series C cumulative convertible preferred stock,
all
of which were issued and outstanding as of that date and 420 shares of Series
D
convertible preferred stock, 413.5 of which were issued and outstanding as
of
that date.
All
outstanding shares of our common stock and preferred stock are duly authorized,
validly issued, fully-paid and non-assessable.
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.
32
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
C 8% Cumulative Convertible Preferred Stock
Stated
Value: The
Series C preferred stock has a stated value of $12,000 per share.
Voting
Rights:
The
Series C preferred stockholders do not have voting rights.
Dividends:
The
Series C preferred stock has an annual dividend rate of 8% until October 1,
2008
and thereafter has an annual dividend rate of 20%. The dividends are payable
quarterly commencing on June 30, 2007. Such dividends shall only be paid after
all outstanding dividends on the Series D preferred stock (with respect to
the
current fiscal year and all prior fiscal years) shall have been paid to the
holders of the Series D preferred stock. Such dividends shall be paid in cash.
Upon the occurrence of an event of default (as defined in the Series C
Certificate of Designations) the dividend rate shall increase to
20%.
Conversion:
Each
share of Series C preferred stock is convertible at a price of $1.00 per common
share. The Series C preferred stock can be converted only to the extent that
the
Series C stockholder will not, as a result of the conversion, hold in excess
of
4.99% of the total outstanding shares of our common stock, provided however
that
this limitation may be revoked by the stockholder upon 61 days prior notice
to
us.
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 C preferred stock stockholders will be
equivalent to the conversion rights of the Series C preferred stock stockholders
prior to such event.
Redemption:
The
Series C preferred stock is not redeemable at the option of the holder. However,
we may redeem the Series C preferred stock by paying to the holder a sum of
money equal to one hundred twenty percent (120%) of the stated value 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 C preferred stock.
Dissolution:
In the
event of any voluntary or involuntary liquidation, dissolution or winding up
of
our affairs, the Series C preferred stock will be treated as senior to our
common stock. After all required payments are made to holders of Series B
preferred stock, the Series C preferred stockholders will be entitled to receive
first, $12,000 per share and all accrued and unpaid dividends. If, upon any
winding up of our affairs, our remaining assets available to pay the holders
of
Series C preferred stock are not sufficient to permit the payment in full,
then
all our assets will be distributed to the holders of our Series C preferred
stock (and any remaining holders of Series B preferred stock as may be required)
on a pro rata basis.
Series
D Convertible Preferred Stock
Stated
Value: The
Series D preferred stock has a stated value of $50,000 per share.
Voting
and Board Rights:
The
Series D preferred stockholders are entitled to vote on all matters on which
the
holders of common stock are entitled to vote. The number of votes to which
each
holder of Series D preferred stock is entitled is equal to the number of shares
of common stock that would be issued to such holder if the Series D Preferred
Stock had been converted at the record date for the meeting of stockholders.
33
Pursuant
to the Securities Purchase Agreement dated March 26, 2008 from and after the
closing of the sale of the Series D preferred stock, Xmark Opportunity Fund,
Ltd. and its affiliates (the “Xmark Entities”), will have the right to designate
one member to our Board of Directors. This right shall last until such time
as
the Xmark Entities no longer hold
at
least one-third of the Series D preferred stock issued to them at closing.
In
addition, the Xmark Entities and Caduceus Capital Master Fund Limited and its
affiliates (together with the Xmark Entities, the “Lead Investors”) will have
the right to designate one observer to attend all meetings of our Board of
Directors, committees thereof and access to all information made available
to
members of the Board. This right shall last until such time as the Lead
Investors no longer hold
at
least one-third of the Series D preferred stock issued to them.
Dividends:
The
Series D preferred stock has a dividend rate of 9% per annum, payable
semi-annually. Such dividends may be paid in cash or in registered shares of
common stock. While any shares of Series D preferred stock remain outstanding,
we are prohibited from paying dividends to common stockholders or any other
class of preferred stock other than Series C preferred stock without the prior
consent of the Series D holders. If consent is given, the holders of outstanding
shares of Series D preferred stock are also entitled to participate in any
dividends paid to common stockholders.
We
have
the financial ability to make all dividend payments and, if necessary, any
payments for liquidated damages, to the Series D Preferred Stock investors.
Following the closing of the sale of Series D preferred stock, we have
approximately $11,000,000 of cash and cash equivalents and approximately
$3,000,000 of capital surplus available for payment of dividends. Furthermore,
the dividends on the Series D Preferred Stock are payable in cash or shares
of
our common stock, at our option.
Conversion:
Each
share of Series D preferred stock is convertible at a price of $0.65 per common
share at any time after issuance. The Series D preferred stock can be converted
only to the extent that the Series B stockholder will not, as a result of the
conversion, beneficially hold in excess of 4.99% or 9.99%, as applicable, of
the
total outstanding shares of our common stock, provided however that this
limitation may be revoked by the stockholder upon 61 days prior notice to the
Company. If there is an effective registration statement covering the shares
of
common stock underlying the outstanding shares of Series D preferred stock
and
the daily volume weighted average price (“VWAP”), as defined in the Series D
Certificate of Designations, of our common stock exceeds $2.00 for 20
consecutive trading days, then the outstanding Series D preferred stock will
automatically convert into common stock at the conversion price then in effect.
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 D preferred stock will be equivalent to
the
conversion rights of the Series D preferred stock stockholders prior to such
event.
Liquidation:
The
Series D preferred stock ranks senior to all other outstanding series of
preferred stock and common stock as to the payment of dividends and the
distribution of assets upon voluntary or involuntary liquidation, dissolution
or
winding up of our affairs. The Series D preferred stockholders will be entitled
to receive first, $50,000 per share and all accrued and unpaid dividends. They
are then entitled to participate with the holders of the remaining classes
of
common stock in the distribution of remaining assets on a pro rata basis. If,
upon any winding up of our affairs, our assets available to pay the holders
of
Series D Preferred Stock are not sufficient to permit the payment in full,
then
all our assets will be distributed to the holders of our Series D Preferred
Stock on a pro rata basis.
If
we
sell, lease or otherwise transfer substantially all of our assets, consummate
a
business combination in which we are not the surviving corporation or, if we
are
the surviving corporation, if the holders of a majority of our common stock
immediately before the transaction do not hold a majority of our common stock
immediately after the transaction, in one or a series of events, change the
majority of the members of our board of directors, or if any person or entity
(other than the holders of Series D Preferred Stock) acquires more than 50%
of
our outstanding stock, then the holders of Series D preferred stock are entitled
to receive the same liquidation preference as described above, except that
after
receiving $50,000 per preferred share and any accrued but unpaid dividends,
they
are not entitled to participate with other classes or common stock in a
distribution of the remaining assets.
34
Other
restrictions: For
as
long as any shares of Series D Preferred Stock remain outstanding, the Company
is prohibited from (i) paying dividends to common stockholders; (ii) amending
the Company’s certificate of incorporation; (iii) issuing any equity security or
any security convertible into or exercisable for any equity security at a price
of $0.65 or less or with rights senior to the Series D Preferred Stock (except
for certain exempted issuances); (iv) increasing the number of shares of Series
D Preferred Stock or issuing any additional shares of Series D Preferred Stock
other than the shares designated in the Series D Certificate of Designations;
(v) selling or otherwise disposing of all or substantially all of the Company’s
assets or intellectual property or entering into a merger or consolidation
with
another company unless Novelos is the surviving corporation, the Series D
Preferred Stock remains outstanding and there are no changes to the rights
and
preferences of the Series D Preferred Stock; (vi) redeeming or repurchasing
any
capital stock other than Series D Preferred Stock; (vii) incurring any new
debt
for borrowed money in excess of $500,000 and (viii) changing the number of
the
Company’s directors.
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.
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.
35
PLAN
OF DISTRIBUTION
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).
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.
36
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 registrant
pursuant to the foregoing provisions, or otherwise, the registrant has been
advised that in the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the Securities Act
of
1933 and is, therefore, unenforceable.
WHERE
YOU CAN FIND MORE INFORMATION
We
are a
reporting company and file annual, quarterly and special reports, and other
information with the Securities and Exchange Commission. Copies of the reports
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 S-1 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:
37
|
·
|
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 has been passed
upon
for us by Foley Hoag LLP, Boston, Massachusetts.
EXPERTS
Stowe
& Degon have audited our financial statements as of December 31, 2007 and
2006 and for the years then ended. These financial statements are incorporated
by reference in this prospectus with reliance upon the independent registered
public accounting firm’s opinion based on its expertise in accounting and
auditing.
38
INFORMATION
INCORPORATED BY REFERENCE
The
SEC
allows us to “incorporate by reference” the information we file with them, which
means that we can disclose important information to you by referring you to
those documents instead of having to repeat the information in this prospectus.
The information incorporated by reference is considered to be part of this
prospectus. We are incorporating by reference our Annual Report on Form 10-KSB
for the fiscal year ended December 31, 2007 filed with the SEC on March 24,
2008, our Current Reports on Form 8-K filed with the SEC on March 29, 2008
and
April 14, 2008 and our Quarterly Report on Form 10-Q for the quarter ended
March
31, 2008 filed with the SEC on May 14, 2008 (the “Reports”). We will provide
without charge to each person, including any beneficial owner, to whom a copy
of
this prospectus is delivered, upon written or oral request, a copy of the
Reports (not including exhibits to such documents unless such exhibits are
specifically incorporated by reference to such document). Requests should be
directed to: Novelos Therapeutics, Inc., One Gateway Center, Suite 504, Newton,
Massachusetts 02458; Telephone: (617) 244-1616. The reports can also be accessed
online through our website at www.novelos.com.
39
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
24. Indemnification of Directors and Officers.
Section
102(b)(7) of the Delaware General Corporation Law allows us to adopt a charter
provision eliminating or limiting the personal liability of directors to us
or
our stockholders for breach of fiduciary duty as directors, but the provision
may not eliminate or limit the liability of directors for (a) any breach of
the
director's duty of loyalty to us or our stockholders, (b) any acts or omissions
not in good faith or which involve intentional misconduct or a knowing violation
of law, (c) unlawful payments of dividends or unlawful stock repurchases or
redemptions under Section 174 of the Delaware General Corporation Law or (d)
any
transaction from which the director derived an improper personal benefit.
Article Seventh of our charter provides that none of our directors shall be
personally liable to us or our stockholders for monetary damages for any breach
of fiduciary duty as a director, subject to the limitations imposed by Section
102(b)(7). Article Seventh also provides that no amendment to or repeal of
Article Seventh shall apply to or have any effect on the liability or the
alleged liability of any director with respect to any acts or omissions of
such
director occurring prior to such amendment or repeal. A principal effect of
Article Seventh is to eliminate or limit the potential liability of our
directors for monetary damages arising from breaches of their duty of care,
unless the breach involves one of the four exceptions described in (a) through
(d) above.
Section
145 of the Delaware General Corporation Law provides, in general, that a
corporation incorporated under the laws of the State of Delaware, such as us,
may indemnify any person who was or is a party or is threatened to be made
a
party to any threatened, pending or completed action, suit or proceeding (other
than a derivative action by or in the right of the corporation) by reason of
the
fact that such person is or was a director, officer, employee or agent of the
corporation, or is or was serving at the request of the corporation as a
director, officer, employee or agent of another enterprise, against expenses
(including attorneys’ fees), judgments, fines and amounts paid in settlement
actually and reasonably incurred by such person in connection with such action,
suit or proceeding if such person acted in good faith and in a manner such
person reasonably believed to be in or not opposed to the best interests of
the
corporation, and, with respect to any criminal action or proceeding, had no
reasonable cause to believe such person's conduct was unlawful. In the case
of a
derivative action, a Delaware corporation may indemnify any such person against
expenses (including attorneys’ fees) actually and reasonably incurred by such
person in connection with the defense or settlement of such action or suit
if
such person acted in good faith and in a manner such person reasonably believed
to be in or not opposed to the best interests of the corporation, except that
no
indemnification will be made in respect of any claim, issue or matter as to
which such person will have been adjudged to be liable to the corporation unless
and only to the extent that the Court of Chancery of the State of Delaware
or
any other court in which such action was brought determines such person is
fairly and reasonably entitled to indemnity for such expenses.
Article
Eighth of our amended and restated certificate of incorporation and Section
5.1
of our bylaws provide that we will indemnify our directors, officers, employees
and agents to the extent and in the manner permitted by the provisions of the
Delaware General Corporation Law, as amended from time to time, subject to
any
permissible expansion or limitation of such indemnification, as may be set
forth
in any shareholders’ or directors’ resolution or by contract.
The
effect of these provisions would be to permit indemnification by us for, among
other liabilities, liabilities arising out of the Securities Act of 1933.
Item
25. Other Expenses of Issuance and Distribution
The
following table provides information regarding the various actual and
anticipated expenses payable by us in connection with the issuance and
distribution of the securities being registered. 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. All
amounts shown are estimates except the Securities and Exchange Commission
registration fee.
II-1
|
Nature
of Expense
|
Amount
|
|||
|
SEC
registration fee
|
$
|
149
|
||
|
Accounting
fees and expenses
|
2,000
|
|||
|
Legal
fees and expenses
|
8,000
|
|||
|
Printing
and related fees
|
2,000
|
|||
|
Miscellaneous
|
1,000
|
|||
|
Total
|
$
|
13,149
|
||
Item
26. Sales of Unregistered Securities
Since
January 2005, we have sold the following securities in reliance on one or more
exemptions from registration under the Securities Act of 1933, as amended,
including the exemption under Section 4(2) thereof:
2008
On
January 16, 2008, we issued 100,000 shares of our common stock to Howard
Schneider, one of our directors, upon the exercise of his stock option at a
price of $0.01 per share for total consideration of $1,000, pursuant to an
option granted in February 2005.
On
April
11, 2008, we issued 113.5 shares of our Series D convertible preferred stock
and
warrants to purchase 4,365,381 shares of our common stock to institutional
investors. We received gross proceeds of $5,675,000 and paid approximately
$200,000 in fees and expenses. In connection with this transaction, 300 shares
of Series B convertible preferred stock were exchanged for 300 shares of Series
D convertible preferred stock. Following the closing of the transaction we
paid
dividends of $740,280 to preferred stockholders.
2007
On
May 2,
2007, we issued 300 shares of our Series B convertible preferred stock and
warrants to purchase 7,500,000 shares of our common stock to institutional
investors. We received gross proceeds of $15,000,000 and paid approximately
$1,300,000 in fees and expenses. We also issued warrants to purchase 900,000
shares of our common stock to Rodman & Renshaw LLC and VFT Special Ventures,
Ltd. (an affiliate of Emerging Growth Equities) as partial consideration for
their placement agent services in connection with the financing.
On
July
6, 2007 we issued 25,000 shares of our common stock to Dr. Kenneth Tew, the
chairman of our Scientific Advisory Board, upon exercise of his stock option
at
a price per share of $0.01 for total consideration of $250, pursuant to an
option granted in April 2004.
2006
On
March
7, 2006, we issued 11,154,073 shares of our common stock and warrants to
purchase 8,365,542 shares of our common stock to 39 accredited investors. We
received gross proceeds of $15,058,005 and paid approximately $1,100,000 in
fees
and expenses.
During
2006, we issued a total of 85,000 shares of our common stock to investor
relations consultants as compensation for services on the following dates and
in
the following amounts: January 23, 2006 20,000 shares; February 27, 2006 15,000
shares; February 28, 2006 20,000 shares; March 28, 2006 10,000 shares; June
22,
2006 10,000 shares; September 22, 2006 10,000 shares.
On
March
27, 2006 we issued 75,000 shares of our common stock to Dr. Kenneth Tew, a
member of our Scientific Advisory Board, upon exercise of his stock option
at a
price per share of $0.01 for total consideration of $750, pursuant to an option
granted in April 2004.
II-2
2005
In
January 2005, we issued a 6% promissory note in the principal amount of $400,000
to an accredited investor. We also issued 10,000,000 shares of our common stock
to this accredited investor (and other accredited investors) as partial
consideration for this loan, a 6% promissory note issued in December 2004 in
the
principal amount of $100,000 and a commitment to provide additional financing
of
up to $500,000 through
August 2005.
On
April
1, 2005, we issued three promissory notes to accredited investors in the
aggregate principal amount of $450,000. We also issued these accredited
investors warrants to purchase an aggregate of 720,000 shares of our common
stock. These holders of our promissory notes converted them into units on May
27, 2005 as described below.
On
May
26, 2005, we issued 586,351 shares of our common stock, with an aggregate deemed
value of $732,941, and $318,713 in cash to holders of our promissory notes
in
exchange for the forgiveness of indebtedness in the amount of $3,139,185, which
resulted in forgiveness of debt income of $2,087,531.
On
May
26, 2005, we issued 1,760,000 shares of our common stock to holders of our
convertible promissory notes in the aggregate principal amount of $1,100,000.
On
May
26, 2005, we issued 2,016,894 shares of our common stock to the Oxford Group,
Ltd, including 907,602 shares to each of two of our directors (one of whom
has
since resigned), in consideration for an amendment to an arrangement for future
royalty payments.
On
May
27, 2005, June 29, 2005, July 29, 2005 and August 9, 2005, we issued an
aggregate of 200 units, each unit initially consisting of 20,000 shares of
our
common stock and warrants to purchase 10,000 shares of our common stock, in
private placement transactions to accredited investors. Holders of $550,000
of
our convertible debt converted debt into 22 of the 200. We received net cash
proceeds of $3,715,000. We paid commissions and finders fees consisting of
$461,000 and warrants to purchase an aggregate of 412,112 shares of our common
stock. vFinance Investments, Inc. and Mercer Capital, Ltd. acted as placement
agents on a best efforts basis. Of the $461,000 paid in commissions and finders
fees, we paid vFinance Investments, Inc. and Mercer Capital Ltd. $292,500.
We
also issued 125,000 shares of our common stock and warrants to purchase an
aggregate of 264,236 shares of our common stock to vFinance Investments, Inc.
and Mercer Capital Ltd. as consideration for placement services rendered in
connection with these private placements.
On
September 30, 2005 and October 3, 2005, we issued an aggregate of 3,200 shares
of our Series A 8% cumulative convertible preferred stock and warrants to
purchase an aggregate of 969,696 shares of our common stock to institutional
investors. We received gross proceeds of $3,200,000 and paid $336,000 in fees
and expenses.
On
October 20, 2005 we issued a total of 55,000 unregistered shares of our common
stock to investor relations consultants as compensation for services.
Item
27. Exhibits
|
Filed
|
Incorporated by Reference
|
|||||||||
|
Exhibit
No.
|
Description
|
with this
Form S-1
|
Form
|
Filing Date
|
Exhibit
No.
|
|||||
|
2.1
|
Agreement
and plan of merger among Common Horizons, Inc., Nove Acquisition,
Inc. and
Novelos Therapeutics, Inc. dated May 26, 2005
|
8-K
|
June
2, 2005
|
99.2
|
||||||
|
2.2
|
Agreement
and plan of merger between Common Horizons and Novelos Therapeutics,
Inc.
dated June 7, 2005
|
10-QSB
|
August
15, 2005
|
2.2
|
||||||
II-3
|
Filed
|
Incorporated by Reference
|
|||||||||
|
Exhibit
No.
|
Description
|
with this
Form S-1
|
Form
|
Filing Date
|
Exhibit
No.
|
|||||
|
3.1
|
Amended
and Restated Certificate of Incorporation filed as Exhibit A to the
Certificate of Merger merging Nove Acquisition, Inc. with and into
Novelos
Therapeutics, Inc. dated May 26, 2005
|
10-QSB
|
August
10, 2007
|
3.1
|
||||||
|
3.2
|
Certificate
of Merger merging Common Horizons, Inc. with and into Novelos
Therapeutics, Inc. dated June 13, 2005
|
10-QSB
|
August
10, 2007
|
3.2
|
||||||
|
|
||||||||||
|
3.3
|
|
Certificate
of Correction dated March 3, 2006
|
|
|
|
10-QSB
|
|
August
10, 2007
|
|
3.3
|
|
3.4
|
Certificate
of Amendment to Amended and Restated Certificate of Incorporation
dated
July 16, 2007
|
10-QSB
|
August
10, 2007
|
3.4
|
||||||
|
3.5
|
Certificate
of Designations of Series B convertible preferred stock
|
10-QSB
|
August
10, 2007
|
3.5
|
||||||
|
3.6
|
Certificate
of Designations of Series C cumulative convertible preferred
stock
|
10-QSB
|
August
10, 2007
|
3.6
|
||||||
|
3.7
|
Certificate
of Designations of Series D convertible preferred stock
|
8-K
|
April
14, 2008
|
4.1
|
||||||
|
3.8
|
Certificate
of Elimination Series A 8% Cumulative Convertible Preferred Stock
of
Novelos Therapeutics, Inc.
|
8-K
|
April
14, 2008
|
4.2
|
||||||
|
3.9
|
By-laws
|
8-K
|
June
17, 2005
|
2
|
||||||
|
5.1
|
Legal
Opinion of Foley Hoag LLP
|
X
|
||||||||
|
10.1
**
|
Employment
agreement with Christopher J. Pazoles dated July 15, 2005
|
10-QSB
|
August
15, 2005
|
10.4
|
||||||
|
10.2
**
|
Employment
Agreement with Harry S. Palmin dated January 31, 2006
|
8-K
|
February
6, 2006
|
99.1
|
||||||
|
10.3
**
|
Compensation
for independent directors
|
8-K
|
December
22, 2006
|
99.1
|
||||||
|
10.4**
|
2000
Stock Option and Incentive Plan
|
SB-2
|
November
16, 2005
|
10.2
|
||||||
|
10.5
**
|
Form
of 2004 non-plan non-qualified stock option
|
SB-2
|
November
16, 2005
|
10.3
|
||||||
|
10.6
**
|
Form
of non-plan non-qualified stock option used from February to May
2005
|
SB-2
|
November
16, 2005
|
10.4
|
||||||
|
10.7
**
|
Form
of non-plan non-qualified stock option used after May 2005
|
SB-2
|
November
16, 2005
|
10.5
|
||||||
|
10.8
|
Form
of common stock purchase warrant issued in March 2005
|
SB-2
|
November
16, 2005
|
10.6
|
||||||
|
10.9
|
Form
of securities purchase agreement dated May 2005
|
8-K
|
June
2, 2005
|
99.1
|
||||||
|
10.10
|
Form
of subscription agreement dated September 30, 2005
|
8-K
|
October
3, 2005
|
99.1
|
||||||
II-4
|
Filed
|
Incorporated by Reference
|
|||||||||
|
Exhibit
No.
|
Description
|
with this
Form S-1
|
Form
|
Filing Date
|
Exhibit
No.
|
|||||
|
10.11
|
Form
of Class A common stock purchase warrant dated September 30,
2005
|
8-K
|
October
3, 2005
|
99.3
|
||||||
|
10.12
|
Form
of share escrow agreement
|
8-K
|
November
3, 2005
|
10.3
|
||||||
|
10.13
|
Consideration
and new technology agreement dated April 1, 2005 with ZAO BAM
|
10-QSB
|
August
15, 2005
|
10.2
|
||||||
|
10.14
|
Letter
agreement dated March 31, 2005 with The Oxford Group, Ltd.
|
10-QSB
|
August
15, 2005
|
10.3
|
||||||
|
10.15
|
Form
of securities purchase agreement dated March 2, 2006
|
8-K
|
March
3, 2006
|
99.2
|
||||||
|
10.16
|
Form
of common stock purchase warrant dated March 2006
|
8-K
|
March
3, 2006
|
99.3
|
||||||
|
10.17
|
Placement
Agent Agreement with Oppenheimer & Co. Inc. dated December 19,
2005
|
8-K
|
March
3, 2006
|
99.4
|
||||||
|
10.18**
|
2006
Stock Incentive Plan
|
10-QSB
|
November
6, 2006
|
10.1
|
||||||
|
10.19
|
Form
of Incentive Stock Option under Novelos Therapeutics, Inc.’s 2006 Stock
Incentive Plan
|
8-K
|
December
15, 2006
|
10.1
|
||||||
|
10.20
|
Form
of Non-Statutory Stock Option under Novelos Therapeutics, Inc.’s 2006
Stock Incentive Plan
|
8-K
|
December
15, 2006
|
10.2
|
||||||
|
10.21
|
Form
of Non-Statutory Director Stock Option under Novelos Therapeutics,
Inc.’s
2006 Stock Incentive Plan
|
8-K
|
December
15, 2006
|
10.3
|
||||||
|
10.22
|
Securities
Purchase Agreement dated April 12, 2007
|
10-QSB
|
May
8, 2007
|
10.1
|
||||||
|
10.23
|
Letter
Amendment dated May 2, 2007 to the Securities Purchase Agreement
|
10-QSB
|
May
8, 2007
|
10.2
|
||||||
|
10.24
|
Registration
Rights Agreement dated May 2, 2007
|
10-QSB
|
May
8, 2007
|
10.3
|
||||||
|
10.25
|
Placement
Agent Agreement with Rodman & Renshaw, LLC dated February 12,
2007
|
10-QSB
|
May
8, 2007
|
10.4
|
||||||
|
10.26
|
Agreement
to Exchange and Consent dated May 1, 2007
|
10-QSB
|
May
8, 2007
|
10.5
|
||||||
|
10.27
|
Form
of Common Stock Purchase Warrant dated May 2, 2007 issued pursuant
to the
Securities Purchase Agreement dated April 12, 2007
|
10-QSB
|
May
8, 2007
|
4.1
|
||||||
II-5
|
Filed
|
Incorporated by Reference
|
|||||||||
|
Exhibit
No.
|
Description
|
with this
Form S-1
|
Form
|
Filing Date
|
Exhibit
No.
|
|||||
|
10.28
|
Form
of Common Stock Purchase Warrant dated May 2, 2007 issued pursuant
to the
Agreement to Exchange and Consent dated May 2, 2007
|
10-QSB
|
May
8, 2007
|
4.2
|
||||||
|
10.29
|
Securities
Purchase Agreement dated March 26, 2008
|
8-K
|
April
14, 2008
|
10.1
|
||||||
|
10.30
|
Amendment
to Securities Purchase Agreement dated April 9, 2008
|
8-K
|
April
14, 2008
|
10.2
|
||||||
|
10.31
|
Registration
Rights Agreement dated April 11, 2008
|
8-K
|
April
14, 2008
|
10.3
|
||||||
|
10.32
|
Form
of Common Stock Purchase Warrant dated April 11, 2008 issued pursuant
to
the Securities Purchase Agreement dated March 26, 2008
|
8-K
|
April
14, 2008
|
4.3
|
||||||
|
10.33
|
Warrant
Amendment Agreement dated April 11, 2008
|
8-K
|
April
14, 2008
|
10.5
|
||||||
|
10.34
|
Amendment
to Registration Rights Agreement dated April 11, 2008
|
8-K
|
April
14, 2008
|
10.4
|
||||||
|
23.1
|
Consent
of Foley Hoag (included in Exhibit 5.1)
|
X
|
5.1
|
|||||||
|
23.2
|
Consent
of Stowe & Degon
|
X
|
||||||||
|
23.3
|
Power
of Attorney (included on signature page)
|
X
|
||||||||
**
Management contract or compensatory plan.
Item
28. Undertakings.
(a)
The
undersigned registrant hereby undertakes to:
(1) File,
during any period in which it offers or sells securities, a post-effective
amendment to this Registration Statement to:
(i) Include
any prospectus required by Section 10(a)(3) of the Securities Act;
(ii) Reflect
in the prospectus any facts or events which, individually or together, represent
a fundamental change in the information in the Registration Statement.
Notwithstanding the foregoing, any increase or decrease in volume of securities
offered (if the total dollar value of securities offered would not exceed that
which was registered) and any deviation from the low or high end of the
estimated maximum offering range may be reflected in the form of prospectus
filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the
changes in volume and price represent no more than a 20 percent change in the
maximum aggregate offering price set forth in the “Calculation of Registration
Fee” table in the effective Registration Statement.
(iii) Include
any additional or changed material information on the plan of
distribution.
(2) For
determining liability under the Securities Act, treat each post-effective
amendment as a new registration statement of the securities offered, and the
offering of the securities at that time to be the initial bona fide
offering.
II-6
(3) File
a
post-effective amendment to remove from registration any of the securities
that
remain unsold at the end of the offering.
(4) For
determining liability of the undersigned small business issuer under the
Securities Act to any purchaser in the initial distribution of the securities,
the undersigned small business issuer undertakes that in a primary offering
of
securities of the undersigned small business issuer pursuant to this
registration statement, regardless of the underwriting method used to sell
the
securities to the purchaser, if the securities are offered or sold to such
purchaser by means of any of the following communications, the undersigned
small
business issuer will be a seller to the purchaser and will be considered to
offer or sell such securities to such purchaser:
(i)
Any
preliminary prospectus or prospectus of the undersigned small business issuer
relating to the offering required to be filed pursuant to Rule 424 (§230.424 of
this chapter);
(ii)
Any
free-writing prospectus relating to the offering prepared by or on behalf of
the
undersigned small business issuer or used or referred to by the undersigned
small business issuer;
(iii)
The
portion of any other free-writing prospectus relating to the offering containing
material information about the undersigned small business issuer or its
securities provided by or on behalf of the undersigned small business issuer;
and
(iv)
Any
other
communication that is an offer in the offering made by the undersigned small
business issuer to the purchaser.
(b) Insofar
as indemnification for liabilities arising under the Securities Act of 1933
(the
“Act”) may be permitted to directors, officers and controlling persons of the
small business issuer pursuant to 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 Act and is, therefore, unenforceable.
(c) Each
prospectus filed pursuant to Rule 424(b)(§230.424(b) of this chapter) as part of
a registration statement relating to an offering, other than registration
statements relying on Rule 430B or other than prospectuses filed in reliance
on
Rule 430A (§230.430A of this chapter), shall be deemed to be part of and
included in the registration statement as of the date it is first used after
effectiveness. Provided that no statement made in a registration statement
or
prospectus that is part of the registration statement or made in a document
incorporated or deemed incorporated by reference into the registration statement
or prospectus that is part of the registration statement will, as to a purchaser
with a time of contract of sale prior to such first use, supersede or modify
any
statement that was made in the registration statement or prospectus that was
part of the registration statement or made in any such document immediately
prior to such date of first use.
II-7
SIGNATURES
In
accordance with the requirements of the Securities Act of 1933, the registrant
certifies that it has reasonable grounds to believe that it meets all of the
requirements of filing on Form S-1 and authorized this registration statement
to
be signed on its behalf by the undersigned, in the City of Newton, Commonwealth
of Massachusetts, on June 3, 2008.
|
NOVELOS
THERAPEUTICS, INC.
|
|
|
/s/
Harry S. Palmin
|
|
|
President
and Chief Executive Officer
|
|
KNOW
ALL
MEN BY THESE PRESENTS, that each individual whose signature appears below
constitutes and appoints Harry S. Palmin and Joanne M. Protano, and each of
them, his true and lawful attorney-in-fact and agent, with full power of
substitution and re-substitution, for him and in his name, place and stead,
in
any and all capacities, to sign any and all amendments (including post-effective
amendments) to this registration statement, and to file the same, with all
exhibits and schedules thereto, and all other documents in connection therewith,
with the Securities and Exchange Commission, granting unto said
attorneys-in-fact and agents, and each of them, full power and authority to
do
and perform each and every act and thing, which they, or either of them, may
deem necessary or advisable to be done in connection with this registration
statement, as fully to all intents and purposes as he might or could do in
person, hereby ratifying and confirming all that said attorneys-in-fact and
agents or any of them, or their substitute or substitutes or any of them, may
lawfully do or cause to be done by virtue hereof.
In
accordance with the requirements of the Securities Act of 1933, this
registration statement was signed by the following persons in the capacities
and
on the dates stated:
|
Signature
|
Title
|
Date
|
||
|
/s/
Harry S. Palmin
|
Chief
Executive Officer and Director
|
June
3, 2008
|
||
|
Harry
S. Palmin
|
(principal executive
officer)
|
|||
|
/s/
Joanne M. Protano
|
Chief
Financial Officer
|
June
3, 2008
|
||
|
Joanne
M. Protano
|
(principal
financial officer and principal accounting officer)
|
|||
|
/s/
Stephen A. Hill
|
Chairman
of the Board of Directors
|
June
3, 2008
|
||
|
Stephen
A. Hill
|
||||
|
/s/
Michael J. Doyle
|
Director
|
June
3, 2008
|
||
|
Michael
J. Doyle
|
||||
|
/s/
Sim Fass
|
Director
|
June
3, 2008
|
||
|
Sim
Fass
|
||||
|
/s/
James S. Manuso
|
Director
|
June
3, 2008
|
||
|
James
S. Manuso
|
||||
|
/s/
David B. McWilliams
|
Director
|
June
3, 2008
|
||
|
David
B. McWilliams
|
||||
|
/s/
Simyon Palmin
|
Director
|
June
3, 2008
|
||
|
Simyon
Palmin
|
||||
|
/s/
Howard M. Schneider
|
Director
|
June
3, 2008
|
||
|
Howard
M. Schneider
|
II-8
EXHIBIT
INDEX
|
Filed
|
Incorporated by Reference
|
|||||||||
|
Exhibit
No.
|
Description
|
with this
Form S-1
|
Form
|
Filing Date
|
Exhibit
No.
|
|||||
|
2.1
|
Agreement
and plan of merger among Common Horizons, Inc., Nove Acquisition,
Inc. and
Novelos Therapeutics, Inc. dated May 26, 2005
|
8-K
|
June
2, 2005
|
99.2
|
||||||
|
2.2
|
Agreement
and plan of merger between Common Horizons and Novelos Therapeutics,
Inc.
dated June 7, 2005
|
10-QSB
|
August
15, 2005
|
2.2
|
||||||
|
3.1
|
Amended
and Restated Certificate of Incorporation filed as Exhibit A to the
Certificate of Merger merging Nove Acquisition, Inc. with and into
Novelos
Therapeutics, Inc. dated May 26, 2005
|
10-QSB
|
August
10, 2007
|
3.1
|
||||||
|
3.2
|
Certificate
of Merger merging Common Horizons, Inc. with and into Novelos
Therapeutics, Inc. dated June 13, 2005
|
10-QSB
|
August
10, 2007
|
3.2
|
||||||
|
3.3
|
Certificate
of Correction dated March 3, 2006
|
10-QSB
|
August
10, 2007
|
3.3
|
||||||
|
3.4
|
Certificate
of Amendment to Amended and Restated Certificate of Incorporation
dated
July 16, 2007
|
10-QSB
|
August
10, 2007
|
3.4
|
||||||
|
3.5
|
Certificate
of Designations of Series B convertible preferred stock
|
10-QSB
|
August
10, 2007
|
3.5
|
||||||
|
3.6
|
Certificate
of Designations of Series C cumulative convertible preferred
stock
|
10-QSB
|
August
10, 2007
|
3.6
|
||||||
|
3.7
|
Certificate
of Designations of Series D convertible preferred stock
|
8-K
|
April
14, 2008
|
4.1
|
||||||
|
3.8
|
Certificate
of Elimination Series A 8% Cumulative Convertible Preferred Stock
of
Novelos Therapeutics, Inc.
|
8-K
|
April
14, 2008
|
4.2
|
||||||
|
3.9
|
By-Laws
|
8-K
|
June
17, 2005
|
2
|
||||||
|
5.1
|
Legal
Opinion of Foley Hoag LLP
|
X
|
||||||||
|
10.1
**
|
Employment
agreement with Christopher J. Pazoles dated July 15, 2005
|
10-QSB
|
August
15, 2005
|
10.4
|
||||||
|
10.2
**
|
Employment
Agreement with Harry S. Palmin dated January 31, 2006
|
8-K
|
February
6, 2006
|
99.1
|
||||||
|
10.3
**
|
Compensation
for independent directors
|
8-K
|
December
22, 2006
|
99.1
|
||||||
|
10.4**
|
2000
Stock Option and Incentive Plan
|
SB-2
|
November
16, 2005
|
10.2
|
||||||
|
10.5
**
|
Form
of 2004 non-plan non-qualified stock option
|
SB-2
|
November
16, 2005
|
10.3
|
||||||
|
10.6
**
|
Form
of non-plan non-qualified stock option used from February to May
2005
|
SB-2
|
November
16, 2005
|
10.4
|
||||||
II-9
|
Filed
|
Incorporated by Reference
|
|||||||||
|
Exhibit
No.
|
Description
|
with this
Form S-1
|
Form
|
Filing Date
|
Exhibit
No.
|
|||||
|
10.7
**
|
Form
of non-plan non-qualified stock option used after May 2005
|
SB-2
|
November
16, 2005
|
10.5
|
||||||
|
10.8
|
Form
of common stock purchase warrant issued in March 2005
|
SB-2
|
November
16, 2005
|
10.6
|
||||||
|
10.9
|
Form
of securities purchase agreement dated May 2005
|
8-K
|
June
2, 2005
|
99.1
|
||||||
|
10.10
|
Form
of subscription agreement dated September 30, 2005
|
8-K
|
October
3, 2005
|
99.1
|
||||||
|
10.11
|
Form
of Class A common stock purchase warrant dated September 30,
2005
|
8-K
|
October
3, 2005
|
99.3
|
||||||
|
10.12
|
Form
of share escrow agreement
|
8-K
|
November
3, 2005
|
10.3
|
||||||
|
10.13
|
Consideration
and new technology agreement dated April 1, 2005 with ZAO BAM
|
10-QSB
|
August
15, 2005
|
10.2
|
||||||
|
10.14
|
Letter
agreement dated March 31, 2005 with The Oxford Group, Ltd.
|
10-QSB
|
August
15, 2005
|
10.3
|
||||||
|
10.15
|
Form
of securities purchase agreement dated March 2, 2006
|
8-K
|
March
3, 2006
|
99.2
|
||||||
|
10.16
|
Form
of common stock purchase warrant dated March 2006
|
8-K
|
March
3, 2006
|
99.3
|
||||||
|
10.17
|
Placement
Agent Agreement with Oppenheimer & Co. Inc. dated December 19,
2005
|
8-K
|
March
3, 2006
|
99.4
|
||||||
|
10.18**
|
2006
Stock Incentive Plan
|
10-QSB
|
November
6, 2006
|
10.1
|
||||||
|
10.19
|
Form
of Incentive Stock Option under Novelos Therapeutics, Inc.’s 2006 Stock
Incentive Plan
|
8-K
|
December
15, 2006
|
10.1
|
||||||
|
10.20
|
Form
of Non-Statutory Stock Option under Novelos Therapeutics, Inc.’s 2006
Stock Incentive Plan
|
8-K
|
December
15, 2006
|
10.2
|
||||||
|
10.21
|
Form
of Non-Statutory Director Stock Option under Novelos Therapeutics,
Inc.’s
2006 Stock Incentive Plan
|
8-K
|
December
15, 2006
|
10.3
|
||||||
|
10.22
|
Securities
Purchase Agreement dated April 12, 2007
|
10-QSB
|
May
8, 2007
|
10.1
|
||||||
|
10.23
|
Letter
Amendment dated May 2, 2007 to the Securities Purchase Agreement
|
10-QSB
|
May
8, 2007
|
10.2
|
||||||
|
10.24
|
Registration
Rights Agreement dated May 2, 2007
|
10-QSB
|
May
8, 2007
|
10.3
|
||||||
|
10.25
|
Placement
Agent Agreement with Rodman & Renshaw, LLC dated February 12,
2007
|
10-QSB
|
May
8, 2007
|
10.4
|
||||||
II-10
|
Filed
|
Incorporated by Reference
|
|||||||||
|
Exhibit
No.
|
Description
|
with this
Form S-1
|
Form
|
Filing Date
|
Exhibit
No.
|
|||||
|
10.26
|
Agreement
to Exchange and Consent dated May 1, 2007
|
10-QSB
|
May
8, 2007
|
10.5
|
||||||
|
10.27
|
Form
of Common Stock Purchase Warrant dated May 2, 2007 issued pursuant
to the
Securities Purchase Agreement dated April 12, 2007
|
10-QSB
|
May
8, 2007
|
4.1
|
||||||
|
10.28
|
Form
of Common Stock Purchase Warrant dated May 2, 2007 issued pursuant
to the
Agreement to Exchange and Consent dated May 2, 2007
|
10-QSB
|
May
8, 2007
|
4.2
|
||||||
|
10.29
|
Securities
Purchase Agreement dated March 26, 2008
|
8-K
|
April
14, 2008
|
10.1
|
||||||
|
10.30
|
Amendment
to Securities Purchase Agreement dated April 9, 2008
|
8-K
|
April
14, 2008
|
10.2
|
||||||
|
10.31
|
Registration
Rights Agreement dated April 11, 2008
|
8-K
|
April
14, 2008
|
10.3
|
||||||
|
10.32
|
Form
of Common Stock Purchase Warrant dated April 11, 2008 issued pursuant
to
the Securities Purchase Agreement dated March 26, 2008
|
8-K
|
April
14, 2008
|
4.3
|
||||||
|
10.33
|
Warrant
Amendment Agreement dated April 11, 2008
|
8-K
|
April
14, 2008
|
10.5
|
||||||
|
10.34
|
Amendment
to Registration Rights Agreement dated April 11, 2008
|
8-K
|
April
14, 2008
|
10.4
|
||||||
|
23.1
|
Consent
of Foley Hoag (included in Exhibit 5.1)
|
X
|
5.1
|
|||||||
|
23.2
|
Consent
of Stowe & Degon
|
X
|
||||||||
|
23.3
|
Power
of Attorney (included on signature page)
|
X
|
||||||||
II-11