424B3: Prospectus filed pursuant to Rule 424(b)(3)
Published on April 27, 2009
Filed pursuant to Rule
424(b)(3)
Registration No.
333-143263
PROSPECTUS
12,000,000
shares of common stock
NOVELOS
THERAPEUTICS, INC.
This
prospectus relates to the resale, from time to time, of up to 12,000,000 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 conversion of a portion of the outstanding shares of
our Series E Preferred Stock
The
selling stockholders will receive all of the proceeds from the sales made under
this prospectus. Accordingly, we will receive no part of the proceeds from sales
made under this prospectus. We are paying the expenses incurred in registering
the shares, but all selling and other expenses incurred by the selling
stockholders will be borne by the selling stockholders.
Our
common stock is quoted on the OTC Electronic Bulletin Board of the National
Association of Securities Dealers, Inc. under the symbol “NVLT.OB.” On April 20,
2009, the last reported sale price of our common stock on the OTC Electronic
Bulletin Board was $0.40 per share.
Investing
in our common stock involves a high degree of risk.
See
risk factors beginning on page 7 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 April 27, 2009
TABLE
OF CONTENTS
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Page
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PROSPECTUS
SUMMARY
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4
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RISK
FACTORS
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7
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FORWARD-LOOKING
STATEMENTS
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17
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USE
OF PROCEEDS
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17
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MARKET
FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
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17
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MANAGEMENT'S
DISCUSSION AND ANALYSIS OR PLAN OF OPERATION
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18
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BUSINESS
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22
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LITIGATION
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30
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PROPERTIES
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30
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MANAGEMENT
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31
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SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
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39
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CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
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42
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PRIVATE
PLACEMENTS OF CONVERTIBLE PREFERRED STOCK AND WARRANTS
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42
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SELLING
STOCKHOLDERS
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46
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DESCRIPTION
OF SECURITIES
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47
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PLAN
OF DISTRIBUTION
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50
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DISCLOSURE
OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT
LIABILITIES
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52
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WHERE
YOU CAN FIND MORE INFORMATION
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52
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LEGAL
MATTERS
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53
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EXPERTS
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53
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FINANCIAL
STATEMENTS
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F-1
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2
No
dealer, salesperson or other person has been authorized to give any information
or to make any representations other than those contained in this prospectus in
connection with the offer contained in this prospectus and, if given or made,
such information or representations must not be relied upon as having been
authorized by us.
Neither
the delivery of this prospectus nor any sale made hereunder shall under any
circumstances create an implication that there has been no change in our affairs
since the date hereof. This prospectus does not constitute an offer to sell or a
solicitation of an offer to buy securities other than those specifically offered
hereby or of any securities offered hereby in any jurisdiction where, or to any
person to whom, it is unlawful to make such offer or solicitation. The
information contained in this prospectus speaks only as of the date of this
prospectus unless the information specifically indicates that another date
applies.
This
prospectus has been prepared based on information provided by us and by other
sources that we believe are reliable. This prospectus summarizes certain
documents and other information in a manner we believe to be accurate, but we
refer you to the actual documents, if any, for a more complete understanding of
what we discuss in this prospectus. In making a decision to invest in the common
stock, you must rely on your own examination of us and the terms of the offering
and the common stock, including the merits and risks involved.
We are
not making any representation to you regarding the legality of an investment in
our common stock under any legal investment or similar laws or regulations. You
should not consider any information in this prospectus to be legal, business,
tax or other advice. You should consult your own attorney, business advisor and
tax advisor for legal, business and tax advice regarding an investment in our
common stock.
3
PROSPECTUS
SUMMARY
The
following summary highlights certain material aspects of the offering for resale
of common stock by the selling stockholders covered by this prospectus but may
not contain all of the information that is important to you. You should read
this summary together with the more detailed information regarding our company,
our common stock and our financial statements and notes to those statements
appearing elsewhere in this prospectus, including the “RISK FACTORS” beginning
on page 7.
Business
We are a
biopharmaceutical company, established in 1996, commercializing oxidized
glutathione-based compounds for the treatment of cancer and
hepatitis.
NOV-002,
our lead compound, is currently in Phase 3 development for non-small cell lung
cancer. NOV-002 is intended for use in combination with chemotherapy
to act as a chemoprotectant and an immunomodulator. Three separate
Phase 2 trials demonstrated clinical activity and safety of NOV-002 in
combination with chemotherapy in non-small cell lung cancer. In May
2006, we finalized a Special Protocol Assessment (SPA) with the FDA for a single
pivotal Phase 3 trial in advanced non-small cell lung cancer in combination with
first-line chemotherapy, and received Fast Track designation in August 2006. The
primary endpoint of this trial is improvement in median overall
survival. Patient enrollment commenced in November 2006 and targeted
enrollment was reached in March 2008. We believe that results for
this trial will be available in late 2009.
NOV-002
is also being developed to treat early-stage breast cancer. In June 2007 we
commenced enrollment in a U.S. Phase 2 neoadjuvant breast trial, which is
ongoing at The University of Miami and The Medical University of South
Carolina to evaluate the ability of NOV-002 to enhance the
effectiveness of chemotherapy. As presented at the San Antonio Breast
Cancer Symposium (December 2008) six pathologic complete responses occurred in
the first 15 women (40%) who have completed chemotherapy and undergone surgery,
which is much greater than the less than 20% historical
expectation in HER-2 negative patients. Furthermore,
patients experienced decreased hematalogic toxicities.
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 May 2008, NOV-002 (plus carboplatin) slowed progression of the
disease in 60% of evaluable patients (nine out of 15 women). The median
progression-free survival was 15.4 weeks, almost double the historical control
of eight weeks. These results were presented at the American Society of Clinical
Oncology in May 2008.
Based on
results to-date, in 2009 we intend to initiate several Phase 2 trials with
NOV-002 in cancers as well as chemotherapy-induced anemia. Our
ability to initiate these trials, and the timing of such trials, will depend on
available funding, principally from partnering arrangements or the issuance of
debt or equity securities.
NOV-205,
our second compound, is intended for use as a hepatoprotective agent with
immunomodulating and anti-inflammatory properties. Our
Investigational New Drug Application for NOV-205 as monotherapy for chronic
hepatitis C has been accepted by the FDA. A U.S. Phase 1b clinical
trial in patients who previously failed treatment with pegylated interferon plus
ribavirin was completed in December 2007. Based on favorable safety
results of that trial, we plan to initiate a longer duration, proof-of-concept
trial in the event we obtain the additional funding necessary for that
purpose. However, there can be no assurance that such funding will be
available.
Both
compounds have completed clinical trials in humans and have been approved for
use in Russia, where they were originally developed. We own all
intellectual property rights worldwide (excluding Russia and other states of the
former Soviet Union) related to compounds based on oxidized glutathione,
including NOV-002 and NOV-205. Our patent portfolio includes six U.S. issued
patents, two European issued patents and one Japanese issued
patent.
4
Private
Placement and Exchange of Shares
On May 2,
2007, we completed a private placement of 300 shares of our Series B Convertible
Preferred Stock and five-year warrants to purchase up to 7,500,000 shares of
common stock with an initial exercise price of $1.25 per share. The shares
of Series B preferred stock were convertible into an aggregate of
15,000,000 shares of common stock.
We
received gross proceeds of $15,000,000 and net proceeds of approximately
$13,700,000 (after deducting placement agents’ fees and transaction costs) from
this private placement.
On April
11, 2008, we completed a private placement of 113.5 shares of our Series D
Convertible Preferred Stock and warrants to purchase up to 4,365,381 shares of
our common stock with an exercise price of $0.65, expiring April 11, 2013. This
sale was made to the existing group of Series B investors. The shares of Series
D preferred stock were convertible into an aggregate of 8,730,755 shares of
common stock. We received gross proceeds of $5,675,000 and net proceeds of
approximately $5,470,000 (after deducting placement agent’s fees and transaction
costs) from this private placement. Upon the closing of the sale of Series D
preferred stock, the holders of our existing Series B preferred stock exchanged
all 300 shares of their Series B preferred stock for 300 shares of Series D
preferred stock. Following the exchange, no shares of Series B Preferred Stock
were outstanding. The purpose of the exchange was to facilitate the reduction in
conversion price of the Series B preferred stock from $1.00 per share to $0.65
per share. Simultaneous with the closing of this private placement,
we executed an amendment to the warrants to purchase 7,500,000 shares of common
stock issued on May 2, 2007 to reduce the exercise price to $0.65 and extend the
expiration date to April 11, 2013.
On
February 11, 2009, we completed a private placement of 200 shares of our Series
E Convertible Preferred Stock and warrants to purchase up to 9,230,769 shares of
our common stock with an exercise price of $0.65, expiring December 31, 2015.
This sale was made to a new investor. The shares of Series E preferred stock are
convertible into an aggregate of 15,384,615 shares of common stock. We received
gross proceeds of $10,000,000 and net proceeds of approximately $9,200,000
(after deducting advisor fees and transaction costs) from this private
placement. Upon the closing of the sale of Series E preferred stock, the holders
of our existing Series D preferred stock exchanged all 413.5 shares of
their Series D preferred stock and accumulated but unpaid dividends thereon
for 445.442875 shares of Series E preferred stock. Following the exchange, no
shares of Series D Preferred Stock were outstanding. The purpose of the exchange
was to enable the new investor to have the same rights and preferences as the
prior Series D investors. Simultaneous with the closing of this private
placement, we executed amendments to warrants to purchase 7,500,000 shares of
common stock issued on May 2, 2007 and warrants to purchase 4,365,381 shares of
common stock issued April 11, 2008 to extend the expiration date of the warrants
to December 31, 2015.
As a
result of the exchange transactions, the common stock being offered pursuant to
this prospectus, previously issuable upon conversion of the Series B preferred
stock, is now issuable upon conversion of the Series E preferred
stock. We have agreed to file another registration statement, in
August 2009, covering the shares issuable upon conversion of (i) the shares
issuable upon conversion of the Series E preferred stock (excluding 12,000,000
shares of common stock issuable upon conversion of the Series E preferred stock
included on this registration statement), (ii) 9,230,769 shares of common stock
issuable upon exercise of the warrants issued on February 11, 2009 and (iii)
11,865,381 shares of common stock issuable upon exercise of warrants issued on
May 2, 2007 and April 11, 2008.
Certain
selling stockholders are offering up to 12,000,000 shares of our common stock
issuable upon conversion of shares of our Series E Convertible Preferred
Stock.
The
Offering
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Securities
Offered:
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12,000,000
shares of our common stock issuable upon conversion of shares of our
Series E Convertible Preferred Stock
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Use
of Proceeds:
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We
will not receive any of the proceeds from the sale by any selling
stockholder of common stock or the conversion of preferred
stock.
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Total
Shares of our Common Stock Outstanding as of April 20,
2009:
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43,975,656
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5
Summary
Financial Information
The
following table provides selected financial and operating data for the periods
indicated:
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Year
Ended
December
31,
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||||||||
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2008
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2007
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|||||||
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Revenue
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$ | 125,968 | $ | − | ||||
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Costs
and expenses
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16,716,985 | 20,294,187 | ||||||
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Other
income
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139,611 | 737,052 | ||||||
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Net
loss
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(16,451,406 | ) | (19,557,135 | ) | ||||
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Net
loss attributable to common stockholders
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(22,960,823 | ) | (29,721,338 | ) | ||||
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Current
assets
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1,392,237 | 11,059,501 | ||||||
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Current
liabilities
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6,617,206 | 7,059,390 | ||||||
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Total
assets
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1,466,038 | 11,107,660 | ||||||
Our
principal executive offices are located at One Gateway Center, Suite 504,
Newton, Massachusetts 02458 and our telephone number is (617)
244-1616.
6
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 this
prospectus indicates that there is substantial doubt about whether we will be
able to continue as a going concern.
The
report from our independent registered public accounting firm included in this
prospectus indicates that factors exist that raise substantial doubt about our
ability to continue as a going concern. We believe that our funds at December
31, 2008, together with the net proceeds of approximately $9,200,000 from the
sale of shares of our Series E preferred stock in February 2009 (see Note 10 to
the financial statements), are adequate to continue operations at budgeted
levels into late 2009. Our ability to execute our operating plan
beyond late 2009 is dependent on our ability to obtain additional capital
(including through the sale of equity and debt securities and by entering into
collaborative arrangements for licensing rights in North America) to fund our
development activities. We plan to pursue these alternatives during 2009, but
there can be no assurance that we will obtain such additional
capital. We anticipate that clinical results from our Phase 3
clinical trial in non-small cell lung cancer will be available in late
2009. The primary endpoint of the trial is increased median overall
survival, to be measured following the occurrence of 725 events
(deaths). The timing and content of those clinical results may affect
our projected cash requirements and our ability to obtain capital. Furthermore,
continuing adverse conditions in the capital markets globally may impair our
ability to obtain funding in a timely manner. We are continuously evaluating
measures to further reduce our costs to preserve existing capital. If
we are unable to obtain sufficient additional funding, we will be
required, beginning in late 2009, to scale back our administrative
activities and clinical development programs, including the Phase 3 clinical
development of our lead drug candidate, NOV-002, or we may have to cease our
operations entirely.
We
may have difficulty raising additional capital for our future
operations.
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 on 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
capital requirements and our ability to meet them depend on many factors,
including:
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the
number of potential products and technologies in
development;
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continued
progress and cost of our research and development
programs;
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progress
with pre-clinical studies and clinical trials, including the results of
our Phase 3 clinical trial expected in late
2009;
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the
time and costs involved in obtaining regulatory
clearance;
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costs
involved in preparing, filing, prosecuting, maintaining and enforcing
patent claims;
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costs
of developing sales, marketing and distribution channels and our ability
to sell our drugs;
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costs
involved in establishing manufacturing capabilities for clinical trial and
commercial quantities of our drugs;
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competing
technological and market
developments;
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market
acceptance of our products;
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costs
for recruiting and retaining management, employees and
consultants;
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7
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costs
for educating physicians;
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our
status as a Bulletin-Board listed company and the prospects for our stock
being listed on a national
exchange;
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uncertainty
and economic instability resulting from terrorist acts and other acts of
violence or war; and
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the
condition of capital markets and the economy generally, both in the U.S.
and globally.
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We may
consume available resources more rapidly than currently anticipated, resulting
in the need for additional funding sooner than expected. 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, while we believe that we have available cash sufficient to
meet our working capital requirements into late 2009, assuming our expense
levels do not exceed our current plan and that we maintain a vendor payment
cycle that is consistent with, or slightly longer than, our past practice.
However, there can be no assurance that these assumptions are
correct. Furthermore, if we do not generate revenues or raise
additional capital, we will not be able to sustain our operations at existing
levels once our current funds are exhausted.
The
failure to complete development of our therapeutic technology, to obtain
government approvals, including required 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 for the patient population
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 using oxidized glutathione-based
compounds, including NOV-002 and NOV-205, we must successfully meet a number of
critical developmental milestones including:
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demonstrating
benefit from delivery of each specific drug for specific medical
indications;
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demonstrating
through pre-clinical and clinical trials that each drug is safe and
effective; and
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demonstrating
that we have established viable Good Manufacturing Practices capable of
potential scale-up.
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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
developmental risks that include the following:
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uncertainties
arising from the rapidly growing scientific aspects of drug therapies and
potential treatments;
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8
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uncertainties
arising as a result of the broad array of alternative potential treatments
related to cancer, hepatitis and other diseases;
and
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anticipated
expense and time believed to be associated with the development and
regulatory approval of treatments for cancer, hepatitis and other
diseases.
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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 for a product, or the
trials are halted by the FDA, we will not be able to achieve any revenue from
such product in the U.S, 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 obtained in the future, 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 is 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, which would result in delays to commercialization and could materially
harm our business. Our clinical trials may not demonstrate sufficient
levels of safety and efficacy necessary to obtain the requisite regulatory
approvals for our drugs, and our proposed drugs may not be approved for
marketing.
We may
encounter delays or rejections based 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 or 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, these products
will be subject to extensive ongoing regulation, including 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 to comply with any applicable regulations could further delay
or preclude development and commercialization of 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 adversely affect our business 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. However, 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 in the United
States. While we have experienced positive preliminary results in the
earlier stage trials for certain indications in the U.S., 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. If this occurs, we may have to cease our operations
entirely.
9
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 operating losses over the next several years as we continue to incur
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.
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 any 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 commercialization and marketing our proposed products in development
will occur, and we do not expect to generate sufficient revenues, from proposed
product sales or otherwise, 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. The lack of facilities of our own in which 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
believe that we have a good working relationship with our contractors. However,
should the situation change, we may be required to relocate these
activities on short notice, and we do not currently have access to alternate
facilities to which 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 obtaining FDA approval and
commercializing our products.
We
are dependent on our collaborative arrangements for the development of our
technologies and business development, exposing 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 arrangements with
universities, hospitals, governmental agencies, charitable foundations,
manufacturers and others. The loss of any of these arrangements, 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 commercially reasonable 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.
10
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. In addition, the use in our clinical trials of
pharmaceutical products that we or our current or potential collaborators may
develop and then subsequently sell may cause us to bear a portion of or all
product liability risks. While we carry an insurance policy covering
up to $5,000,000 per occurrence and $5,000,000 in the aggregate of
liability incurred in connection with such claims should they arise, there can
be no assurance 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. 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. A successful product liability claim or
series of claims brought against us could have a material adverse effect on our
business, financial condition and results of operations.
Acceptance
of our products in the marketplace is uncertain and failure to achieve market
acceptance will prevent or delay our ability to generate revenues.
Our
future financial performance will depend, at least in part, 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:
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the
receipt of regulatory clearance of marketing claims for the uses that we
are developing;
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the
establishment and demonstration of the advantages, safety and efficacy of
our technologies;
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pricing
and reimbursement policies of government and third-party payers such as
insurance companies, health maintenance organizations and other health
plan administrators;
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our
ability to attract corporate partners, including pharmaceutical companies,
to assist in commercializing our intended products;
and
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our
ability to market our products.
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Physicians,
patients, payers or the medical community in general may be unwilling to accept,
use or recommend any of our products. If we are unable to obtain
regulatory approval or commercialize and market our proposed products as
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:
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cease
selling, incorporating or using any of our technologies and/or products
that incorporate the challenged intellectual property, which would
adversely affect our ability to generate
revenue;
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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
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redesign
our products, which would be costly and
time-consuming.
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If
we are unable to protect or enforce our rights to intellectual property
adequately or to secure rights to third-party patents, we may lose valuable
rights, experience reduced market share, assuming any, or incur costly
litigation to protect our intellectual property 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.
11
The
patent positions of biotechnology and pharmaceutical companies that involve
licensing agreements, including ours, are frequently uncertain and involve
complex legal and factual questions. In addition, the coverage
claimed in a patent application can be significantly reduced before the patent
is issued or in subsequent legal proceedings. Consequently, our patent
applications and any issued and licensed patents may not provide protection
against competitive technologies or may be held invalid if challenged or
circumvented. Our competitors may also independently develop products
similar to ours or design around or otherwise circumvent patents issued or
licensed to us. In addition, the laws of some foreign countries may
not protect our proprietary rights to the same extent as U.S. law.
We also
rely on trade secrets, technical know-how and continuing technological
innovation to develop and maintain our competitive position. Although
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.
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. Even if our products are
approved for manufacture and sale by applicable regulatory authorities, we may
not be able to manufacture sufficient quantities at an acceptable cost, and our
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. We intend to enter into agreements with third parties at the appropriate
time to sell our products or we may develop our own sales and marketing
force. However, 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.
12
We may be
unable to engage qualified distributors. Even if engaged, these
distributors may:
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fail
to adequately market our products;
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fail
to satisfy financial or contractual obligations to
us;
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offer,
design, manufacture or promote competing products;
or
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cease
operations with little or no
notice.
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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 of 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 are
conducting 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 $4 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 our competitors’ financial,
marketing, manufacturing and other resources.
We operate
with limited day-to-day business management, serve as a vehicle to hold certain
technology for possible future exploration, and have been and will continue to
be engaged in the development of new drugs and therapeutic
technologies. As a result, our resources are limited and we may
experience management, operational or technical challenges inherent in such
activities and novel technologies. Competitors have developed or are
in the process of developing technologies that are, or in the future may be, the
basis for competition. Some of these technologies may accomplish
therapeutic effects similar to those of our technology, but through different
means. 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.
13
The
potential widespread acceptance of therapies that are alternatives to ours may
limit market acceptance of our products even if they are
commercialized. Many of our targeted diseases and conditions can also
be treated by other medication or drug delivery technologies. These
treatments may be widely accepted in medical communities and have a longer
history of use. The established use of these competitive drugs may
limit the potential for our technologies and products to receive widespread
acceptance if commercialized.
If
users of our products are unable to obtain adequate reimbursement from
third-party payers, or if new restrictive legislation is adopted, market
acceptance of our products may be limited, which could limit revenue we might
otherwise generate from sales of our products.
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 adversely affect our ability to generate future revenues and
achieve profitability, including by limiting the future revenues and
profitability of our potential customers, suppliers and collaborative
partners. For example, in certain foreign markets, pricing or
profitability of prescription pharmaceuticals is subject to government
control. In the U.S., federal and state governments have focused and
will likely continue to focus, on healthcare reform, including initiatives
directed at lowering the total cost of health care and the cost of prescription
pharmaceuticals, as well as other reforms 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 our success will depend on our ability 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 resources reasonably necessary 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. 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 which may result in additional costs.
14
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:
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announcements or press releases
relating to the bio-pharmaceutical sector or to our own business or
prospects;
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regulatory,
legislative, or other developments affecting us or the healthcare industry
generally;
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the
dilutive effect of conversion of our Series B or Series C preferred stock
into common stock at conversion rates or the exercise of options and
warrants at below-current-market
prices;
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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
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market
conditions specific to biopharmaceutical companies, the healthcare
industry and the stock market
generally.
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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.
15
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 E preferred stock beneficially
own, in the aggregate, approximately 56% of our outstanding voting shares,
subject to certain blocking provisions that may be waived with 61 days
notice. The interests of our current officers, directors and Series E
investors may differ from the interests of other
stockholders. Further, our current officers, directors and Series E
investors may have the ability to significantly affect the outcome of all
corporate actions requiring stockholder approval, including the following
actions:
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the
election of directors;
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the
amendment of charter documents;
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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
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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.
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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,
could reduce the market price of our common stock or could result in adjustments
to conversion or exercise prices of outstanding preferred stock and warrants
(resulting in these securities becoming convertible into or exercisable for, as
the case may be, a greater number of shares of our common stock), or could
obligate us to issue additional shares of common stock to certain of our
stockholders.
We
are prohibited from taking certain actions and entering into certain
transactions without the consent of holders of our Series E preferred
stock.
For as
long as any shares of Series E Preferred Stock remain outstanding we are
prohibited from taking certain actions or entering into certain transactions
without the prior consent of specific holders of outstanding shares of Series E
preferred stock (currently consisting of Xmark Opportunity Partners, OrbiMed
Advisors LLC and Purdue Pharma L.P.). 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 E Preferred Stock (except for certain exempted issuances), increasing the
number of shares of Series E Preferred Stock or issuing any additional shares of
Series E Preferred Stock other than the 735 shares designated in the Series E
Certificate of Designations, or changing the number of our
directors. We are also prohibited from entering into certain
transactions such as:
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selling
or otherwise disposing of all or substantially all of our assets (and in
the case of licensing, any material intellectual property) or entering
into a merger or consolidation with another company unless we are the
surviving corporation, the Series E Preferred Stock remains outstanding
and there are no changes to the rights and preferences of the Series E
Preferred Stock;
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redeeming
or repurchasing any capital stock other than Series E Preferred Stock;
or
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incurring
any new debt for borrowed money in excess of
$500,000.
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Even
though our board of directors may determine 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 specific holders of the outstanding shares
of Series E Preferred Stock. The interests of the holders of Series E
preferred stock may differ from those of stockholders
generally. Moreover, the relationship of Purdue Pharma with
Mundipharma (our collaborator on most non-U.S. development, manufacturing and
commercialization of NOV-002) has the potential of creating situations where the
interests of the Company and those of Purdue Pharma may conflict. If
we are unable to obtain consent from each of the holders identified above, we
may be unable to complete actions or transactions that our board of directors
has determined are in the best interest of the Company and its
shareholders.
16
We
were unable to pay dividends to our preferred stockholders on June 30, 2008,
September 30, 2008 and December 31, 2008, we do not expect to be able to pay
dividends to preferred stockholders on March 31, 2009, and we may be unable to
pay dividends to preferred stockholders when due in future periods.
As a
result of continuing losses during 2008, we did not have legally available funds
for the payment of dividends under Delaware corporate
law. Accordingly, we were unable to pay dividends totaling $1,689,323
that were accrued in respect of the Series D and Series C preferred stock as of
December 31, 2008. All outstanding shares of our Series D preferred
stock (and rights associated therewith, including accrued but unpaid dividends)
were exchanged for shares of Series E preferred stock on February 11, 2009. Our
ability to pay cash 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. We anticipate that future dividends
on Series E preferred stock will be paid by issuing shares of common stock or
additional shares of Series E preferred stock, which will result in additional
dilution to existing shareholders. We anticipate that the accrued unpaid
dividend on our Series C preferred stock will continue to
accumulate.
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 of Financial
Condition and Results of Operations” and “Business.” We assume no obligation to
update our forward-looking statements to reflect new information or
developments. We urge readers to review carefully the risk factors described in
this prospectus and the other documents that we file with the Securities and
Exchange Commission. You can read these documents at www.sec.gov .
WE
UNDERTAKE NO OBLIGATION TO PUBLICLY UPDATE OR REVISE ANY FORWARD-LOOKING
STATEMENTS WHETHER AS A RESULT OF NEW INFORMATION, NEW EVENTS OR ANY OTHER
REASON, OR REFLECT ANY EVENTS OR CIRCUMSTANCES AFTER THE DATE OF THIS PROSPECTUS
OR THE DATE OF ANY APPLICABLE PROSPECTUS SUPPLEMENT THAT INCLUDES
FORWARD-LOOKING STATEMENTS.
USE
OF PROCEEDS
The
selling stockholders will receive all of the proceeds from the sale of the
shares offered for sale by them under this prospectus. We will not receive any
proceeds from the resale of shares by the selling stockholders covered by this
prospectus.
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.
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Fiscal
Year 2007
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High
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Low
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||||||
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First
quarter
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$ | 1.24 | $ | 0.85 | ||||
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Second
quarter
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1.40 | 0.82 | ||||||
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Third
quarter
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0.90 | 0.45 | ||||||
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Fourth
quarter
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0.67 | 0.43 | ||||||
17
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Fiscal
Year 2008
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High
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Low
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||||||
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First
Quarter
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$ | 0.82 | $ | 0.43 | ||||
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Second
Quarter
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0.64 | 0.44 | ||||||
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Third
Quarter
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0.54 | 0.35 | ||||||
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Fourth
Quarter
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0.49 | 0.19 | ||||||
On April
20, 2009 there were 89 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 E preferred stock are outstanding or as long
as there are accumulated but unpaid dividends on our Series C preferred stock.
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.
MANAGEMENT'S
DISCUSSION AND ANALYSIS OR PLAN OF OPERATION
Overview
We are a
biopharmaceutical company, established in 1996, commercializing oxidized
glutathione-based compounds for the treatment of cancer and
hepatitis.
NOV-002,
our lead compound, is currently in Phase 3 development for non-small cell lung
cancer. NOV-002 is intended for use in combination with chemotherapy
to act as a chemoprotectant and an immunomodulator. Three separate
Phase 2 trials demonstrated clinical activity and safety of NOV-002 in
combination with chemotherapy in non-small cell lung cancer. In May
2006, we finalized a Special Protocol Assessment (SPA) with the FDA for a single
pivotal Phase 3 trial in advanced non-small cell lung cancer in combination with
first-line chemotherapy, and received Fast Track designation in August 2006. The
primary endpoint of this trial is improvement in median overall
survival. Patient enrollment commenced in November 2006 and targeted
enrollment was reached in March 2008. We believe that results for
this trial will be available in late 2009.
NOV-002
is also being developed to treat early-stage breast cancer. In June 2007 we
commenced enrollment in a U.S. Phase 2 neoadjuvant breast trial, which is
ongoing at The University of Miami and The Medical University of South
Carolina to evaluate the ability of NOV-002 to enhance the
effectiveness of chemotherapy. As presented at the San Antonio Breast
Cancer Symposium (December 2008) six pathologic complete responses occurred in
the first 15 women (40%) who have completed chemotherapy and undergone surgery,
which is much greater than the less than 20% historical
expectation in HER-2 negative patients. Furthermore,
patients experienced decreased hematalogic toxicities.
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 May 2008, NOV-002 (plus carboplatin) slowed progression of the
disease in 60% of evaluable patients (nine out of 15 women). The median
progression-free survival was 15.4 weeks, almost double the historical control
of eight weeks. These results were presented at the American Society of Clinical
Oncology in May 2008.
18
Based on
results to-date, in 2009 we intend to initiate several Phase 2 trials with
NOV-002 in cancers as well as chemotherapy-induced anemia. Our
ability to initiate these trials, and the timing of such trials, will depend on
available funding, principally from collaborative arrangements or the issuance
of debt or equity securities.
NOV-205,
our second compound, is intended for use as a hepatoprotective agent with
immunomodulating and anti-inflammatory properties. Our
Investigational New Drug Application for NOV-205 as monotherapy for chronic
hepatitis C has been accepted by the FDA. A U.S. Phase 1b clinical
trial in patients who previously failed treatment with pegylated interferon plus
ribavirin was completed in December 2007. Based on favorable safety
results of that trial, we plan to initiate a longer duration, proof-of-concept
trial in the event we obtain the additional funding necessary for that
purpose. However, there can be no assurance that such funding will be
available.
Both
compounds have completed clinical trials in humans and have been approved for
use in Russia, where they were originally developed. We own all
intellectual property rights worldwide (excluding Russia and other states of the
former Soviet Union) related to compounds based on oxidized glutathione,
including NOV-002 and NOV-205. Our patent portfolio includes six U.S. issued
patents, two European issued patents and one Japanese issued
patent.
Results
of Operations
Revenue. Revenue
consists of amortization of upfront license fees received in connection with
partner agreements and income received from a grant from the U.S. Department of
Health and Human Services.
Research and
development
expense.
Research and development expense consists of costs incurred in identifying,
developing and testing product candidates, which primarily consist of salaries
and related expenses for personnel, fees paid to professional service providers
for independent monitoring and analysis of our clinical trials, costs of
contract research and manufacturing and costs to secure intellectual
property. We are currently developing two proprietary compounds,
NOV-002 and NOV-205. To date, most of our research and development
costs have been associated with our NOV-002 compound.
General and
administrative expense. General and administrative expense
consists primarily of salaries and other related costs for personnel in
executive, finance and administrative functions. Other costs include facility
costs, insurance, costs for public and investor relations, directors’ fees and
professional fees for legal and accounting services
Years
Ended December 31, 2008 and 2007
Revenue. During
the year ended December 31, 2008 we recognized $33,000 in license fees in
connection with our collaboration with Lee’s Pharmaceutical (HK) Ltd. (“Lee’s
Pharma”), which commenced in December 2007. Under the terms of our
agreement with Lee’s Pharma, the Company received an upfront license fee of
$500,000 in March 2008 and is entitled to receive up to $1,700,000 in future
milestone payments upon the completion of development and marketing milestones
by Lee’s Pharma. The $500,000 initial payment received is being
amortized over the estimated term of the agreement, 15 years. During
the year ended December 31, 2008, we also recognized $93,000 in grant revenue
related to a grant received from the U.S. Department of Health and Human
Services. The related costs are included as a component of research and
development expense.
Research and
Development. Research and development expense for
the year ended December 31, 2008 was $14,527,000, compared to $17,428,000 for
the year ended December 31, 2007. The $2,901,000, or 17%, decrease in research
and development expense was due to a combination of factors. In March
2008, we reached the enrollment target for our Phase 3 clinical trial of
NOV-002, and an increasing number of patients completed their treatment regimen
throughout 2008. As a result, certain clinical costs have
leveled out or declined. The cost of the chemotherapy drug to be provided to
patients at clinical sites in Europe decreased by
$1,669,000. Clinical investigator expenses, which are affected by the
number of patients that remain on treatment, decreased by
$952,000. Drug manufacturing and distribution costs (including
storing and shipping chemotherapy drug) decreased by
$777,000. Salaries and related costs increased $385,000, principally
from the hiring of additional personnel in late 2007 and early 2008 as well as
salary increases that were effective at the beginning of
2008. Overhead costs such as travel and postage increased by
$130,000.
19
General and
Administrative. General and administrative expense
for the year ended December 31, 2008 was $2,190,000, compared to $2,866,000 for
the year ended December 31, 2007. The $676,000, or 24%, decrease in general and
administrative expense was due principally to a $799,000 decrease in accrued
expense for potential liquidated damages associated with registration rights
agreements. We had accrued an estimate for such damages in 2007 and
those damages were then waived in connection with the sale of Series D Preferred
Stock during 2008 (see Note 4). Stock-based compensation also
decreased by $53,000 in the year ended December 31, 2008 compared to the prior
year. These decreases were partially offset by a $144,000 increase in
professional fees, principally those related to partnering and investor
activities and a $32,000 increase in salary, directors fees and
overhead.
Interest
Income. Interest income for the year ended
December 31, 2008 was $131,000 compared to $730,000 for the same period in
2007. This decrease is a result of lower cash balances as well as a
decline in prevailing interest rates.
Preferred Stock Dividends. During the
year ended December 31, 2008 we paid cash dividends to Series B and C preferred
stockholders of $740,000 and accrued $1,689,000 of dividends due to our Series C
and D preferred stockholders. The accrued dividends were not paid
because we did not have legally available funds for the payment of dividends
under Delaware corporate law. In February 2009, all outstanding
shares of Series D preferred stock and associated rights, including accrued
dividends totaling $1,597,000 ($1,396,000 of which had accrued at December 31,
2008) were exchanged for 445.442875 shares of Series E preferred
stock. During the year ended December 31, 2008 we also recorded
deemed dividends to preferred stockholders totaling $4,417,000. This
amount represents the value attributed to the reduction in exercise and
conversion prices of the warrants and preferred stock issued in May 2007 in
connection with the financing that occurred in April 2008, as described in Note
4 to the financial statements.
The
deemed dividends, cash dividends and accrued dividends have been included in the
calculation of net loss attributable to common stockholders of $22,961,000, or
$0.56 per share, for the year ended December 31, 2008. The deemed
dividends and cash dividends are excluded from our net loss (from operating
activities) of $16,451,000 or $0.40 per share, for the year ended December 31,
2008.
During
the year ended December 31, 2007 we paid cash dividends to Series A and C
preferred stockholders of $261,000 and dividends of $563,000 to Series B
preferred stockholders. An additional $337,000 of dividends were
declared and accrued but not paid to Series B preferred
stockholders. During the year ended December 31, 2007 we also
recorded deemed dividends to preferred stockholders totaling $9,003,000
(including a payment of $40,000 made upon the exchange of Series A for Series C
preferred shares). This amount represents the value attributed to the
beneficial conversion feature of the Series B convertible preferred stock
of $7,824,000 and the fair value of warrants and cash of $1,179,000 transferred
to the former Series A preferred stockholders in connection with the exchange of
their shares for shares of Series C preferred stock that were subordinated to
the Series B shares. The deemed dividends and cash dividends have
been included in the calculation of net loss attributable to common stockholders
of $29,721,000, or $0.76 per share, for the year ended December 31,
2007. The deemed dividends and cash dividends are excluded from our
net loss (from operating activities) of $19,557,000 or $0.50 per share, for the
year ended December 31, 2007.
Liquidity
and Capital Resources
We have
financed our operations since inception through the sale of securities and the
issuance of debt (which was subsequently paid off or converted into equity). As
of December 31, 2008, we had $1,262,000 in cash and equivalents.
During
the year ended December 31, 2008, approximately $17,332,000 in cash was used in
operations, primarily due to a net loss of $16,451,000, a net decrease of
$1,827,000 in accounts payable and accrued liabilities and a $3,000 increase in
other current assets. Deferred revenue increased by $467,000 as a result of a
payment received in connection with a licensing arrangement (net of revenue
recognized under the arrangement during the year). The cash impact of the loss
was offset by non-cash stock-based compensation expense of $453,000 and
depreciation, amortization and loss on disposal of fixed assets totaling
$23,000. During the year ended December 31, 2008, cash of
approximately $1,136,000 was provided by investing activities resulting from the
release of restrictions on $1,185,000 of cash that had been previously
restricted in connection with a standby letter of credit, offset by payments of
$49,000 to purchase fixed assets.
20
During
the year ended December 31, 2008, we received net proceeds of $5,470,000 from
the sale of our Series D Preferred stock (see Note 4 to the financial
statements), net proceeds of $2,987,000 from the sale of common stock and
proceeds of $1,000 from the exercise of stock options. We paid
dividends totaling $740,000 to our Series B and Series C preferred
stockholders.
We
believe that we have adequate funds at December 31, 2008, including the proceeds
from the sale of Series E preferred stock in February 2009 (see Note 10 to the
financial statements), to continue operations at budgeted levels into late
2009. Our ability to execute our operating plan beyond late 2009 is
dependent on our ability to obtain additional capital (including through the
sale of equity and debt securities and by entering into collaborative
arrangements for licensing rights in North America) to fund our development
activities. We plan to pursue these alternatives during 2009, but there can be
no assurance that we will obtain the additional capital necessary to fund our
business beyond late 2009. We anticipate that clinical results
from our Phase 3 clinical trial in non-small cell lung cancer will be available
in late 2009. The primary endpoint of the trial is increased median
overall survival, to be measured following the occurrence of 725 events
(deaths). The timing and content of those clinical results may impact
our projected cash requirements and our ability to obtain capital. Furthermore,
continuing adverse conditions in the capital markets globally may affect our
ability to obtain funding in a timely manner. We are continuously evaluating
measures to further reduce our costs to preserve existing capital. If
we are unable to obtain sufficient additional funding, we will be
required, beginning in late 2009, to scale back our administrative
activities and clinical development programs, including the Phase 3 clinical
development of our lead drug candidate, NOV-002, or we may be required to cease
operations entirely.
Critical
Accounting Policies
The
preparation of financial statements and related disclosures in conformity with
accounting principles generally accepted in the United States (GAAP) requires
management to make certain estimates, judgments and assumptions that affect the
reported amounts of assets and liabilities as of the date of the financial
statements, as well as the reported amounts of revenues and expenses during the
periods presented. Actual results could differ from those
estimates. We review these estimates and assumptions periodically and
reflect the effects of revisions in the period that they are determined to be
necessary.
We
believe that the following accounting policies reflect our more significant
judgments and estimates used in the preparation of our financial
statements.
Accrued
Liabilities. As part of the process of preparing financial
statements, we are required to estimate accrued liabilities. This process
involves identifying services that have been performed on our behalf, and
estimating the level of service performed and the associated cost incurred for
such service as of each balance sheet date in our financial statements. Examples
of estimated expenses for which we accrue include: contract service fees such as
amounts paid to clinical research organizations and investigators in conjunction
with clinical trials; fees paid to contract manufacturers in conjunction with
the production of clinical materials; and professional service fees, such as for
lawyers and accountants. In connection with such service fees, our
estimates are most affected by our understanding of the status and timing of
services provided relative to the actual levels of services incurred by such
service providers. The majority of our service providers invoice us
monthly in arrears for services performed. In the event that we do
not identify certain costs that have begun to be incurred, or we over- or
underestimate the level of services performed or the costs of such services, our
reported expenses for such period would be too high or too low. The
date on which certain services commence, the level of services performed on or
before a given date and the cost of such services are often determined based on
subjective judgments. We make these judgments based on the facts and
circumstances known to us in accordance with generally accepted accounting
principles.
21
Stock-based
Compensation. We account for stock-based compensation in
accordance with Statement of Financial Accounting Standards (SFAS) 123R, Share-Based Payment, or
SFAS 123R. SFAS 123R requires measurement of the cost of employee
services received in exchange for an award of equity instruments based on the
grant-date fair value of the award. That cost is recognized over the
period during which an employee is required to provide service in exchange for
the award, the requisite service period (usually the vesting period). We
account for transactions in which services are received from non-employees in
exchange for equity instruments based on the fair value of such services
received or of the equity instruments issued, whichever is more reliably
measured, in accordance with SFAS 123 and the Emerging Issues Task Force (EITF)
Issue 96-18, Accounting
for Equity Instruments That Are Issued to Other than Employees for Acquiring, or
in Conjunction with Selling, Goods or Services, or EITF
96-18.
Accounting
for equity instruments granted or sold by us under SFAS 123R and EITF 96-18
requires fair-value estimates of the equity instrument granted or sold. If our
estimates of the fair value of these equity instruments are too high or too low,
our expenses may be over- or understated. For equity instruments granted or sold
in exchange for the receipt of goods or services, we estimate the fair
value of the equity instruments based on consideration of factors that we deem
to be relevant at that time.
BUSINESS
Overview
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 corporation 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 treatment of lung cancer under
a Special Protocol Assessment and Fast Track. NOV-002 is also in
Phase 2 development for treatment of early-stage breast cancer and
chemotherapy-resistant ovarian cancer. In February 2009, Novelos entered into a
collaboration with Mundipharma International Corporation Limited (“Mundipharma”)
to develop, manufacture and commercialize NOV-002 in Europe and
Japan. NOV-205, our second compound, is in Phase 1b development for
the treatment of chronic hepatitis C in non-responders. Both
compounds have been licensed to Lee’s Pharmaceutical (HK) Ltd. (“Lee’s Pharma”)
for development, manufacturing and commercialization in China.
NOV-002,
our lead compound, acts together with chemotherapy as a chemoprotectant and a
chemopotentiator. Three separate Phase 2 trials demonstrated clinical
activity and safety of NOV-002 in combination with chemotherapy in non-small
cell lung cancer. In May 2006, we finalized a Special Protocol
Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for a single
pivotal Phase 3 trial in non-small cell lung cancer 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. We
expect that the results of this trial will be available in late
2009.
NOV-002
is also being developed to treat early-stage breast cancer. In June 2007 we
commenced enrollment in a U.S. Phase 2 neoadjuvant breast trial, which is
ongoing at The University of Miami and The Medical University of South
Carolina to evaluate the ability of NOV-002 to enhance the
effectiveness of chemotherapy. As presented at the San Antonio Breast
Cancer Symposium in December 2008, six pathologic complete responses occurred in
the first 15 women (40%) who have completed chemotherapy and undergone surgery,
which is much greater than the less than 20% historical expectation in HER-2
negative patients. Furthermore, patients experienced decreased
hematalogic toxicities.
NOV-002
is also being developed to treat chemotherapy-resistant ovarian
cancer. In a U.S. Phase 2 chemotherapy-resistant ovarian cancer trial
conducted at Massachusetts General Hospital and Dana-Farber Cancer Institute
from July 2006 through May 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. These results were presented at the American Society of Clinical
Oncology in May 2008.
22
Based on
results to date, we intend to initiate several Phase 2 trials with NOV-002 in
cancers as well as chemotherapy-induced anemia. Our ability to
initiate these trials in 2009 will depend on available funding, principally from
partnering arrangements or the issuance of debt or equity
securities.
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 has been accepted
by the FDA. A U.S. Phase 1b clinical trial in patients who previously
failed treatment with pegylated interferon plus ribavirin was completed in
December 2007. Based on favorable safety results of that trial, we
plan to initiate a longer duration, proof-of-concept trial in the event we
obtain the additional funding necessary for that purpose. However,
there can be no assurance that such funding will be available.
Both compounds have completed clinical
trials in humans and have been approved for use in Russia, where they were
originally developed. We own all intellectual property rights
worldwide (excluding Russia and other states of the former Soviet Union) related
to compounds based on oxidized glutathione, including NOV-002 and
NOV-205.
Our
intellectual property portfolio of issued patents includes six 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. We believe that the breadth of our
intellectual property will 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
particularly in non-small cell lung cancer, an indication with large and growing
unmet medical needs. For example, according to 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 represented 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 were consistent with 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
late-2009). In February 2009, we entered into a collaboration with
Mundipharma under which we granted Mundipharma exclusive rights to develop,
manufacture and commercialize NOV-002 in Europe and Japan. In
December 2007 we entered into a collaboration agreement with Lee’s Pharma (which
is 30% owned by Sigma-Tau Group) under which we granted Lee’s Pharma exclusive
rights to develop, manufacture and commercialize NOV-002 for cancer and NOV-205
for hepatitis in China, Hong Kong, Macau and Taiwan.
In legacy
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 intend to concentrate
clinical development efforts on chronic hepatitis C, which we believe represents
a more direct path to regulatory approval and has the potential to provide
patients with an improved therapy regimen compared to those currently
available. In December 2007, based on a favorable safety profile, we
concluded a U.S. Phase 1b clinical trial for the treatment of chronic hepatitis
C in non-responders. We plan to commence a proof-of-concept trial in
the event we obtain the additional funding necessary for that
purpose. However, there can be no assurance that such funding will be
available. In the event that we are able to complete this trial
successfully, we intend to explore licensing opportunities with third parties
for the development, manufacture and commercialization of
NOV-205.
23
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 within the medical research community 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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Protein
folding/stability
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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, or 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, or 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, and 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 would
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.
24
NOV-002
NOV-002
is an injectable, small-molecule formulation of a natural metabolite that is
currently being developed for use in combination with chemotherapy for treatment
of lung, breast and ovarian cancers.
NOV-002
for Non-Small Cell Lung Cancer
In the
U.S., NOV-002 is in Phase 3 development for treatment of 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 390 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 2008. Over 566,000 U.S.
cancer patients were expected to die in 2008, 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. According to the American Cancer Society, approximately 215,000
people were expected to be diagnosed with lung cancer in 2008 in the U.S., with
approximately 162,000 deaths. According to the American Cancer
Society, approximately 1,500,000 new cases of lung cancer were expected
worldwide in 2007 and approximately 1,350,000 deaths were projected from lung
cancer in 2007. According to a Rodman and Renshaw report dated
December 2006, the pharmaceutical market for treating lung cancer was
approximately $800 million per year in the U.S. and $1.8 billion worldwide,
expected to grow to greater than $8 billion worldwide 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 (defined as greater
than 50% tumor shrinkage) 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 unmet need for
efficacious, and cost-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 non-small cell lung cancer 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 believe that NOV-002
may be used in combination with first-line chemotherapy treatments and may be
complementary to second-line and recently emerging third-line
products. Furthermore, we believe that NOV-002 may have utility in
all stages of non-small cell lung cancer and in other solid tumor types as
well.
25
The
Russian non-clinical and clinical data set (which includes clinical safety and
efficacy data, 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 trial was to demonstrate
safety, detect trends towards efficacy, compare routes of administration and
support initiation of a Phase 3 trial. 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 late 2009.
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 (i.e. patients who had not
received prior chemotherapy) were randomized to one of three groups for six
months of treatment as follows:
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Group
A: NOV-002, administered intravenously and intramuscularly, in combination
with cytotoxic chemotherapy (carboplatin with
paclitaxel);
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Group
B: NOV-002, administered intravenously and subcutaneously, in combination
with cytotoxic chemotherapy; and
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Group
C: Cytotoxic chemotherapy alone was administered to this control
group.
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Based on
the study protocol, the intent-to-treat analysis of the best overall objective
tumor response (i.e., complete or partial tumor shrinkage) showed the
following:
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Six
out of 13 (46%) patients in Group A demonstrated objective tumor
response;
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11
out of 16 (69%) patients in Group B demonstrated objective tumor response;
and
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|
|
·
|
five
out of 15 (33%) in Group C, the control group, demonstrated objective
tumor response.
|
The
difference in objective tumor response between Groups B and Group C (69% versus
33%) was statistically significant (p=0.044).
Further,
NOV-002-treated patients (i.e., Group A and Group B) better tolerated cytotoxic
chemotherapy as evidenced by their ability to receive more cycles of
chemotherapy compared to the control group (Group C). 100% of
patients in Group B and 85% of patients in Group A were able to complete four
cycles of chemotherapy, while only 50% of control group patients in Group C were
able to do so. The differences between treated versus control groups
was statistically significant (p=0.004).
In St.
Petersburg, Russia, a multi-center, randomized, open-label study was conducted
during 1996-1998 to evaluate the safety and efficacy of NOV-002 in patients with
advanced non-small cell lung cancer. In this study, patients
receiving NOV-002 in combination with chemotherapy had a significantly increased
one-year survival rate over the control group (63% treated group vs. 17%
control, p<0.01). In addition, ability to conduct daily
activities, quality of life, tolerance to chemotherapy, hematologic parameters
and kidney/liver toxicity markers appeared to improve or normalize in patients
receiving NOV-002 in comparison to those in the control group. As in
the U.S. Phase 1/2 trial, patients receiving NOV-002 were able to receive
significantly more cycles of chemotherapy (p<0.01). 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.
26
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. MUSC is collaborating on the trial with the Braman Family
Breast Cancer Institute at the Sylvester Comprehensive Care Center University of
Miami Miller School of Medicine (Sylvester). Alberto Montero, MD,
Assistant Professor of Medicine at Sylvester, is the Principal
Investigator.
Breast
cancer remains a serious public health concern throughout the
world. According to the American Cancer Society, approximately
183,000 women in the US were expected to be diagnosed with breast cancer in
2008, and approximately 41,000 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 pathologic complete response (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 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.
As of
December 2008, 19 women have been enrolled, with six pCRs already demonstrated
in the first 15 women (40%) who have completed chemotherapy and undergone
surgery, which is much greater than the less than 20% historical expectation in
HER-2 negative patients. Furthermore, NOV-002 was associated with
decreased hematologic toxicities and with decreased use of growth factors
(Ethropoiesis Stimulating Agents, which are potentially harmful)
relative to historical experience. Detailed results were presented 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 in the third quarter 2009, with trial conclusion anticipated in
mid-2010.
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 2008 and 15,500 women are expected to die
from it. According to a Rodman and Renshaw report dated December
2006, the pharmaceutical market for treating ovarian cancer was 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.
27
In Russia
in 1998, twenty ovarian cancer case studies were analyzed. All of
these patients were treated for three cycles with platinum-based chemotherapy
but continued with progressive disease according to qualitative assessments and
Cancer Antigen 125. The patients were then treated with NOV-002 for
three to four weeks, followed by three more cycles of the same platinum-based
chemotherapy (to which they previously failed to respond to) in conjunction with
NOV-002. The observed 40% objective tumor response rate across these
case studies is much higher than would ordinarily be expected in patients who
had previously been non-responsive to platinum-based
chemotherapy. 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 (i.e., no tumor
growth).
In a U.S.
Phase 2 chemotherapy-resistant ovarian cancer trial at Massachusetts General
Hospital and Dana-Farber Cancer Institute from July 2006 through May 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. These results
were presented at the American Society of Clinical Oncology in May
2008. We plan to initiate a second Phase 2 trial in
chemotherapy-resistant ovarian cancer patients in the event we obtain the
additional funding necessary for that purpose. However, there can be no
assurance that such funding will be available.
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, a September 2006 publication of Nature Reviews Drug Discovery
estimated the current global market to be in excess of $3 billion per
year, and estimated it would grow to more than $8 billion by 2010. The Centers for Disease
Control and Prevention (CDC), estimated that in 2003, 3.9 million persons in the
U.S. were infected with hepatitis C, and 2.7 million persons in the U.S. had
chronic infection. The CDC further estimated that there are
approximately 30,000 new hepatitis C infections and 8,000-10,000 hepatitis
C-related deaths each year in the U.S.
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 had
been treated in previous anecdotal studies. After relatively short
treatment periods (one to two 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 one to three months of post-treatment
follow-up. In addition, NOV-205 was shown to improve 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 or
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
plan to initiate a longer duration proof-of-concept trial in the event we obtain
the additional funding necessary for that purpose. However, there can
be no assurance that such funding will be available.
28
Non-clinical
Research Program
Our
non-clinical research program is aimed at gaining a better understanding of the
mechanism(s) of action of our oxidized glutathione-based drug products and
adding to the Russian non-clinical data 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 a 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 mechanisms of action and to facilitate
the design and execution of clinical studies and the interactions with the FDA
and the scientific community. Funded research collaborations have
been conducted or are underway at other academic/scientific institutions
including Harvard/Massachusetts General Hospital, the Wistar Institute, the
University of Massachusetts Medical Center and the University of Miami 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, 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.
Similar
to NOV-002, NOV-205’s active pharmaceutical ingredient is manufactured in
compliance with current Good Manufacturing Practices in a single, 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 six 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. Novelos has entered into
a collaboration with Mundipharma to develop, manufacture and commercialize
NOV-002 in Europe and Japan. NOV-205, our second compound, is in
Phase 1b development for the treatment of chronic hepatitis C in
non-responders. Both compounds have been licensed to Lee’s Pharma for
development, manufacture and commercialization in China.
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.
29
Employees
As of
March 1, 2009 we had eight 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:
|
|
·
|
Pre-clinical
laboratory tests, in
vivo pre-clinical studies, and formulation
studies;
|
|
|
·
|
The
submission to the FDA of an Investigational New Drug Application for human
clinical testing, which must become effective before human clinical trials
can commence;
|
|
|
·
|
Adequate
and well controlled human clinical trials to establish the safety and
efficacy of the product;
|
|
|
·
|
The
submission of a New Drug Application or Biologic Drug License Application
to the FDA; and
|
|
|
·
|
FDA
approval of the New Drug Application or Biologic Drug License Application
prior to any commercial sale or shipment of the
product.
|
In
addition to obtaining FDA approval for each product, each product manufacturing
facility must be registered with and approved by the
FDA. Manufacturing facilities are subject to biennial inspections by
the FDA and must comply with the FDA’s Good Manufacturing Practices for
products, drugs and devices.
Whether
or not FDA approval has been obtained, approval of a product by regulatory
authorities in foreign countries must be obtained prior to the commencement of
commercial sales of the drug in such countries. The requirements
governing the conduct of clinical trials and drug approvals vary widely from
country to country, and the time required for approval may be longer or shorter
than that required for FDA approval. Although there are some
procedures for unified filings for certain European countries, in general, each
country has its own procedures and requirements.
LITIGATION
We are
not a party to any legal proceedings the outcome of which, in the opinion of our
management, would have a material adverse effect on our business, financial
condition, or results of operations.
PROPERTIES
We lease
our executive 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 and we anticipate obtaining
an extension on the lease. 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.
30
MANAGEMENT
Our
current directors and executive officers are:
|
Name
|
Age
|
Position
|
||
|
Stephen
A. Hill, B.M. B.Ch., M.A., F.R.C.S.
|
50
|
Chairman
of the Board
|
||
|
Harry
S. Palmin
|
39
|
President,
Chief Executive Officer, Director
|
||
|
Elias
B. Nyberg, DVM, BVSc, MACVS, MRCVS, MBA
|
55
|
Vice
President of Regulatory, Quality and Compliance
|
||
|
Christopher
J. Pazoles, Ph.D.
|
58
|
Vice
President of Research and Development
|
||
|
Joanne
M. Protano
|
40
|
Vice
President, Chief Financial Officer and Treasurer
|
||
|
Kristin
C. Schuhwerk
|
38
|
Vice
President of Clinical Development and Operations
|
||
|
Michael
J. Doyle (1) (2) (3)
|
50
|
Director
|
||
|
Sim
Fass, Ph.D. (1) (2) (3)
|
67
|
Director
|
||
|
James
S. Manuso, Ph.D.
|
60
|
Director
|
||
|
David
B. McWilliams (2) (3)
|
65
|
Director
|
||
|
Howard
M. Schneider (1) (3)
|
65
|
Director
|
_________________________
|
(1)
|
Member
of the audit committee.
|
|
(2)
|
Member
of the compensation committee.
|
|
(3)
|
Member
of the nominating and corporate governance
committee.
|
Our
executive officers are appointed by, and serve at the discretion of, our board
of directors.
Stephen A.
Hill. Dr. Hill was elected our chairman of the board of
directors in September 2007. Dr. Hill has served as the President and Chief
Executive Officer of Solvay Pharmaceuticals, Inc. since April
2008. Prior to joining Solvay, Dr. Hill had served as ArQule's
President and Chief Executive Officer since April 1999. Prior to his
tenure at ArQule, Dr. Hill was the Head of Global Drug Development at F.
Hoffmann-La Roche Ltd. from 1997 to 1999. Dr. Hill joined Roche in 1989 as
Medical Adviser to Roche Products in the United Kingdom. He held several senior
positions at Roche, including Medical Director where he was responsible for
clinical trials of compounds across a broad range of therapeutic areas,
including CNS, HIV, cardiovascular, metabolic and oncology products.
Subsequently, he served as Head of International Drug Regulatory Affairs at
Roche headquarters in Basel, Switzerland, where he led the regulatory
submissions for seven major new chemical entities. Dr. Hill also was a member of
Roche's Portfolio Management, Research, Development and Pharmaceutical Division
Executive Boards. Prior to Roche, Dr. Hill served seven years with the National
Health Service in the United Kingdom in General and Orthopedic Surgery. Dr. Hill
is a Fellow of the Royal College of Surgeons of England and holds his scientific
and medical degrees from St. Catherine's College at Oxford
University.
Harry S.
Palmin. Mr. Palmin has served as our president and a director
since 1998 and our chief executive officer since January 2005. From
1998 to September 2005, he served as our acting chief financial
officer. From 1996 to 1998, he was a vice president at Lehman
Brothers and from 1993 to 1996, he was an associate at Morgan Stanley &
Co. Mr. Palmin earned a B.A. in economics and business and a M.A. in
international economics and finance from the International Business School at
Brandeis University. He has also studied at the London School of
Economics and the Copenhagen Business School.
Elias B.
Nyberg. Dr. Nyberg has served as our vice president of
regulatory, quality and compliance since May 2008. Prior to his
employment with Novelos, since September 2006, Dr. Nyberg was a regulatory
advisor to several companies including Labopharm and Novartis Phramaceuticals,
Inc. From February 2004 to September 2006 he was the Vice President
Regulatory Affairs for CombinatoRx. From April 2001 to January 2004
he served as the Senior Director International Regulatory Affairs for
Biogen. Dr. Nyberg has also held senior regulatory positions with INC
Research/PRA International Inc., Astra Arcus AB, Pfizer Pharmaceuticals and
Ciba-Geigy. Prior to his tenure in the biotechnology industry, Dr.
Nyberg practiced as a veterinarian for 12 years, specializing in exotic
animals. He undertook his primary veterinary training in the
Philippines followed by post doctorate work in South Africa and Australia. Dr.
Nyberg earned an MBA in England and his specialty (diplomate) boards in Exotic
Animal (Avian) Medicine (MACVS) in Australia. He is also a member of the Royal
College of Veterinary Surgeons (MRCVS) in London.
31
Christopher J.
Pazoles. Dr. Pazoles has served as our vice president of
research and development since July 2005. From May 2004 to June 2005,
he held a senior research and development position at the Abbott Bioresearch
Center, a division of Abbott Laboratories. From October 2002 to
January 2004, he served as chief operating officer and head of research and
development at ALS Therapy Development Foundation. From 1994 to
October 2002, Dr. Pazoles served as vice president of research for Phytera,
Inc. From 1981 to 1994, he served as a researcher and senior manager
with Pfizer. Dr. Pazoles holds a Ph.D. in microbiology from the
University of Notre Dame.
Joanne M.
Protano. Ms. Protano was appointed our vice president,
chief financial and accounting officer, and treasurer in December
2007. She previously held the position of Senior Director of Finance
and Controller of the Company from June 2006 to December 2007. From
1996 to 2006, she held various management and senior management positions with
Ascential Software, Inc. and predecessor companies including Assistant
Controller, Reporting for Ascential Software, Vice President and Chief Financial
Officer for the Ascential Software Division of Informix Software, Inc. and
Corporate Controller of Ardent Software, Inc. Prior to her tenure in
the technology industry, from 1990 to 1996 she was employed by Deloitte and
Touche LLP as an audit manager, serving technology and healthcare
clients. Ms. Protano received a B.S. in business administration from
Bryant College.
Kristin C. Schuhwerk. Ms.
Schuhwerk was appointed our vice president of clinical development and
operations in December 2007. She previously served as our
Director/Senior Director of Operations from July 2005 to December
2007. Prior to her employment at Novelos, she worked in the
biopharmaceutical industry managing and overseeing business operations for
multiple global Phase 2 and 3 clinical studies. From 2002 to 2005 she
held the positions of Senior Project Manager and Director of Planning and
Business Operations in Clinical Development at Antigenics, Inc., a cancer
biotechnology company. From 1993 to 2002, she held research, project management
and management positions at Boston University Medical Center, Parexel
International, AstraZeneca and Brigham & Women’s Hospital. Ms.
Schuhwerk earned a B.S. degree in Chemistry from the University of New
Hampshire.
Michael J.
Doyle. Mr. Doyle has served as one of our directors since
October 2005. Since October 2007 he has served as the chief executive
officer of Medsphere Systems Corporation. From April 2006 to June
2007, he served as chief executive officer of Advantedge Healthcare
Solutions. From January 2005 to March 2006, he served as chief
executive officer of Windward Advisors. From March 2000 to December
2004, Mr. Doyle served as chairman and chief executive officer of
Salesnet. From 1989 to 1997, he served as chairman and chief
executive officer of Standish Care/Carematrix, a company he
founded. He received a B.S. in biology from Tufts University and a
M.B.A. with a concentration in finance and health care from the University of
Chicago.
Sim Fass. Dr. Fass
has served as one of our directors since February 2005. Dr. Fass, now
retired, served as chief executive officer and chairman of Savient
Pharmaceuticals from 1997 to 2004, its president and chief executive officer
from 1984 to 1997, and its chief operating officer from 1983 to
1984. From 1980 to 1983, Dr. Fass served as vice president and
general manager of Wampole Laboratories. From 1969 to 1980, he held a
number of marketing, sales and senior management positions at Pfizer, Inc in
both pharmaceuticals and diagnostics. He received a B.S. in biology
and chemistry from Yeshiva College and a doctoral degree in developmental
biology/biochemistry from the Massachusetts Institute of
Technology.
32
James S.
Manuso. Dr. Manuso was elected as one of our directors in
August 2007. Since January 2005, Dr. Manuso has served as Chairman,
President and Chief Executive Officer of SuperGen, Inc. and has served as a
director of SuperGen since February 2001. Dr. Manuso is co-founder
and former president and chief executive officer of Galenica Pharmaceuticals,
Inc. Dr. Manuso co-founded and was general partner of PrimeTech
Partners, a biotechnology venture management partnership, from 1998 to 2002, and
Managing General Partner of The Channel Group LLC, an international life
sciences corporate advisory firm. He was also president of Manuso,
Alexander & Associates, Inc., management consultants and financial advisors
to pharmaceutical and biotechnology companies. Dr. Manuso was a vice
president and Director of Health Care Planning and Development for The Equitable
Companies (now Group Axa), where he also served as Acting Medical
Director. He currently serves on the board of privately-held KineMed,
Inc. and Merrion Pharmaceuticals Ltd. (Dublin, Ireland). Dr. Manuso
earned a B.A. in economics and chemistry from New York University, a Ph.D. in
experimental psychophysiology from the Graduate Faculty of The New School
University, a certificate in health systems management from Harvard Business
School, and an executive M.B.A. from Columbia Business School.
David B.
McWilliams. Mr. McWilliams has served as one of our directors
since March 2004. From February 2004 to December 2004, Mr. McWilliams
performed chief executive officer services for us. Mr. McWilliams is
currently retired. From August 2004 to July 2008, Mr. McWilliams
served as chief executive officer of Opexa Therapeutics, Inc. (formerly
PharmaFrontiers Corp.). From 1992 to March 2002, he served as
president, chief executive officer and a director of Encysive Pharmaceuticals
(formerly Texas Biotech). From 1989 to 1992, Mr. McWilliams served as
president, chief executive officer and director of Zonagen. From 1984
to 1988, he served as president and chief executive officer of Kallestad
Diagnostics. From 1980 to 1984, he served as president of Harleco
Diagnostics Division. From 1972 to 1980, he was an executive at
Abbott Laboratories, rising to general manager for South Africa. From
1969 to 1972, he was a management consultant at McKinsey &
Co. Mr. McWilliams is also a director of ApoCell
Biosciences, Houston Technology Center and Opexa
Therapeutics. Mr. McWilliams received a M.B.A. in finance from the
University of Chicago and a B.A. in chemistry from Washington and Jefferson
College.
Howard M.
Schneider. Mr. Schneider has served as one of our directors
since February 2005. Mr. Schneider is currently
retired. From January to December 2003, he served as chief executive
officer of Metrosoft, Inc., and had been an advisor to such company from July to
December 2002. From May 2000 to May 2001, he served as president of
Wofex Brokerage, Inc. and from 1965 to 1999, he served as an executive at
Bankers Trust Company holding a variety of positions in the commercial banking
and investment banking businesses. Mr. Schneider received a B.A. in
economics from Harvard College and a M.B.A. from New York
University.
Compensation
of Directors and Executive Officers
Executive
Officer Compensation
Summary
Compensation: The following table sets forth certain
information about the compensation we paid or accrued with respect to our
principal executive officer and our two most highly compensated executive
officers (other than our chief executive officer) who served as executive
officers during the year ended December 31, 2008 and whose annual
compensation exceeded $100,000 for that year.
Other
annual compensation in the form of perquisites and other personal benefits has
been omitted as the aggregate amount of those perquisites and other personal
benefits was less than $10,000.
33
Summary
Compensation Table
|
Name and Principal Position
|
Year
|
Salary
($)
|
Bonus
($) (3)
|
Option
Awards ($) (4)
|
All other
compensation
($)
|
Total ($)
|
||||||||||||||||
|
Harry
S. Palmin (1)
|
2008
|
$ | 270,000 | $ | 40,500 | $ | 110,560 | $ | 0 | $ | 421,060 | |||||||||||
|
President,
Chief Excutive
|
2007
|
245,000 | 75,000 | 59,660 | 0 | 379,660 | ||||||||||||||||
|
Officer
|
||||||||||||||||||||||
|
Christopher
J. Pazoles (1)
|
2008
|
$ | 235,000 | $ | 35,250 | $ | 55,280 | $ | 0 | $ | 325,530 | |||||||||||
|
Vice
President of Research
|
2007
|
216,720 | 60,000 | 37,288 | 0 | 314,008 | ||||||||||||||||
|
and
Development
|
||||||||||||||||||||||
|
Kristin
C. Schuhwerk (1) (2)
|
2008
|
$ | 200,000 | $ | 30,000 | $ | 55,280 | $ | 0 | $ | 285,280 | |||||||||||
|
Vice
President of Clinical
|
2007
|
169,904 | 50,000 | 37,288 | 0 | 257,192 | ||||||||||||||||
|
Development
and Operations
|
||||||||||||||||||||||
___________________________
|
(1)
|
There
has been no increase to executive base salaries for
2009.
|
|
(2)
|
Ms.
Schuhwerk was appointed as an officer in December 2007. The compensation
listed for 2007 was paid to her in her capacity as senior
director of operations.
|
|
(3)
|
Bonus
amounts for 2008 were paid in 2009. Bonus amounts for 2007 were
paid in 2008.
|
|
(4)
|
The
fair value of each stock award was estimated on the grant date using the
Black-Scholes option-pricing model.
|
Employment
Agreements
On
January 31, 2006, we entered into an employment agreement with Harry Palmin
effective January 1, 2006, whereby he agreed to serve as our president and chief
executive officer for an initial term of two years at an annual salary of
$225,000. The agreement is automatically renewed for successive one-year terms
unless notice of termination is provided by either party at least 90 days prior
to the end of such term. The agreement was renewed for an additional
one-year term on January 1, 2009 in accordance with its terms. On
December 17, 2007, the Board of Directors approved an increase in Mr. Palmin’s
annual salary to $270,000 effective January 1, 2008. He is eligible to receive
an annual cash bonus at the discretion of the compensation committee and he is
entitled to participate in our employee fringe benefit plans or programs
generally available to our senior executives. The agreement provides that in the
event that we terminate Mr. Palmin without cause or he resigns for good reason
(as defined below), we will (i) pay Mr. Palmin his pro rata share of the average
of his annual bonus paid during the two fiscal years preceding his termination;
(ii) pay Mr. Palmin his base salary for 11 months after the date of termination;
(iii) continue to provide him benefits for 11 months after the date of
termination; and (iv) fifty percent of his unvested stock options will vest. The
agreement also contains a non-compete provision, which prohibits Mr. Palmin from
competing with us for one year after termination of his employment with
us.
“Cause”
means (i) gross neglect of duties for which employed; (ii) committing fraud,
misappropriation or embezzlement in the performance of duties as our employee;
(iii) conviction or guilty or nolo plea of a felony or misdemeanor involving
moral turpitude; or (iv) willfully engaging in conduct materially injurious to
us or violating a covenant contained in the employment agreement.
“Good
Reason” means (i) the failure of our board of directors to elect Mr. Palmin to
the offices of president and chief executive officer; (ii) the failure by our
stockholders to continue to elect Mr. Palmin to our board of directors; (iii)
our failure to pay Mr. Palmin the compensation provided for in the employment
agreement, except for across the board cuts applicable to all of our officers on
an equal percentage basis, provided that such reduction is approved by our board
of directors; (iv) relocation of Mr. Palmin’s principal place of employment to a
location beyond 50 miles of Newton, Massachusetts; (v) a reduction of base
salary or material reduction in other benefits or any material change by us to
Mr. Palmin’s function, duties, authority, or responsibilities, which change
would cause Mr. Palmin’s position with us to become one of lesser
responsibility, importance, or scope; and (vi) our material breach of any of the
other provisions of the employment agreement.
34
On July
15, 2005, we entered into an employment agreement with Christopher J. Pazoles
whereby he agreed to serve as our vice president of research and development for
an initial term of two years. The agreement is automatically renewed
for successive one-year terms unless notice of termination is provided by either
party at least 60 days prior to the end of such term. The agreement was renewed
for an additional one-year term on July 15, 2008 in accordance with its
terms. The agreement provides for minimum salary and bonus amounts
during the first two years of his employment. These minimum amounts
have been satisfied. Dr. Pazoles’ agreement provides that he is
entitled to participate in our employee fringe benefit plans or programs
generally available to our senior executives. The agreement further
provides that in the event that we terminate Dr. Pazoles without cause or he
resigns for good reason (as defined below), we will (i) pay Dr. Pazoles his base
salary through the remainder of the term of his employment agreement in monthly
installments; (ii) continue to provide him benefits for 12 months after the date
of termination; and (iii) pay, on a prorated basis, any minimum bonus or other
payments earned.
Dr.
Pazoles also entered into a nondisclosure and development agreement with us,
which prohibits him from competing with us and soliciting our employees or
customers during the term of his employment and for two years
thereafter. If we terminate his employment without cause, this
prohibition will only extend for six months after his termination.
“Cause”
means Dr. Pazoles (i) has willfully failed, neglected, or refused to perform his
duties under the employment agreement; (ii) has been convicted of or pled guilty
or no contest to a crime involving a felony; or (iii) has committed any act of
dishonesty resulting in material harm to us.
“Good
Reason” means that Dr. Pazoles has resigned due to our failure to meet any of
our material obligations to him under the employment agreement.
Outstanding
Equity Awards at Fiscal Year-End
The
following table sets forth certain information regarding stock options held as
of December 31, 2008 by the executive officers named in the summary compensation
table.
|
Individual Grants
|
|||||||||||||||
|
Name
|
Year
of Grant
|
Number of
securities
underlying
unexercised
options
(#)
exercisable
|
Number of
securities
underlying
unexercised
options
(#)
unexercisable
|
Exercise or
base price
($/share)
|
Expiration
date
|
||||||||||
|
Harry
S. Palmin
|
2008
|
(1)
|
— | 400,000 | $ | 0.43 |
12/15/2018
|
||||||||
|
2007
|
(1)
|
66,666 | 133,334 | 0.45 |
12/17/2017
|
||||||||||
|
2006
|
(1)
|
100,000 | 50,000 | 0.91 |
12/11/2016
|
||||||||||
|
2005
|
(2)
|
250,000 | — | 0.01 |
1/31/2015
|
||||||||||
|
2005
|
(2)
|
150,000 | — | 0.01 |
3/31/2015
|
||||||||||
|
2004
|
(3)
|
330,000 | — | 0.01 |
4/1/2014
|
||||||||||
|
2003
|
(4)
|
7,130 | — | 0.70 |
8/1/2013
|
||||||||||
|
Christopher
J. Pazoles.
|
2008
|
(1)
|
— | 200,000 | $ | 0.43 |
12/15/2018
|
||||||||
|
2007
|
(1)
|
41,666 | 83,334 | 0.45 |
12/17/2017
|
||||||||||
|
2006
|
(1)
|
66,666 | 33,334 | 0.91 |
12/11/2016
|
||||||||||
|
2005
|
(5)
|
200,000 | — | 0.01 |
4/8/2015
|
||||||||||
|
2004
|
(6)
|
16,667 | — | 0.01 |
4/1/2014
|
||||||||||
|
Kristin
C. Schuhwerk
|
2008
|
(1)
|
— | 200,000 | $ | 0.43 |
12/15/2018
|
||||||||
|
2007
|
(1)
|
41,666 | 83,334 | 0.45 |
12/17/2017
|
||||||||||
|
2006
|
(1)
|
50,000 | 25,000 | 0.91 |
12/11/2016
|
||||||||||
|
2005
|
(7)
|
100,000 | — | 2.20 |
7/1/2015
|
||||||||||
|
(1)
|
These
shares vest annually in increments of one-third over three years from the
date of grant. The exercise price equals the closing price on
the date of grant.
|
35
|
(2)
|
These
shares initially vested over a two-year period. Pursuant to
their terms, the shares fully vested upon the completion of a non-bridge
loan financing, which occurred in the second quarter of
2005. The exercise price equals the fair market value of our
common stock on the date of grant as determined by our board of
directors.
|
|
(3)
|
These
shares initially vested one-third upon grant and one third annually over
the following two years. Pursuant to their terms, one additional year of
vesting occurred upon the completion of a non-bridge loan financing, which
occurred in the second quarter of 2005. The exercise price
equals the fair market value of our common stock on the date of grant as
determined by our board of
directors.
|
|
(4)
|
These
shares vest annually in increments of one-third over three years from the
date of grant. The exercise price equals the fair market value of our
common stock on the date of grant as determined by our board of
directors.
|
|
(5)
|
These
shares vested in increments of one-fourth every six months over two years
from the date of grant. The exercise price equals the fair market value of
our common stock on the date of grant as determined by our board of
directors.
|
|
(6)
|
These
shares represent the fully vested portion of an option grant made to Mr.
Pazoles in consideration of consulting services delivered during
2004. Pursuant to their terms, the shares vested at the
completion of the consulting engagement and expire ten years from the date
of grant.
|
|
(7)
|
These
shares vest in increments of one-fourth every six months over two years
from the date of grant. The exercise price equals the closing price on the
date of grant.
|
Options
granted pursuant to the 2006 Stock Incentive Plan will become fully vested upon
a termination event within one year following a change in control, as
defined. A termination event is defined as either termination of
employment other than for cause or constructive termination resulting from a
significant reduction in either the nature or scope of duties and
responsibilities, a reduction in compensation or a required
relocation.
Director
Compensation
Summary
Compensation: The following table sets forth certain
information about the compensation we paid or accrued with respect to our
directors who served during the year ended December 31, 2008.
36
|
Name and Principal Position
|
Year
|
Director
Fees
($) (3)
|
Option
Awards
($) (4)
|
All other
compensation
($)
|
Total ($)
|
|||||||||||||
|
Stephen
A. Hill, Chairman (1)
|
2008
|
$ | 38,000 | $ | 37,924 | $ | — | $ | 75,924 | |||||||||
|
Michael
J. Doyle, Director (1)
|
2008
|
30,250 | 37,924 | — | 68,174 | |||||||||||||
|
Sim
Fass, Director (1)
|
2008
|
30,250 | 37,924 | — | 68,174 | |||||||||||||
|
James
S. Manuso, Director (1)
|
2008
|
23,000 | 37,924 | 60,924 | ||||||||||||||
|
David
B. McWilliams, Director (1)
|
2008
|
26,750 | 37,924 | — | 64,674 | |||||||||||||
|
Simyon
Palmin, Director and director of
Russian relations (2)
|
2008
|
— | — | 88,133 | 88,133 | |||||||||||||
|
Howard
M. Schneider, Director (1)
|
2008
|
36,750 | 37,924 | — | 74,674 | |||||||||||||
_____________________________
Simyon
Palmin resigned from our board of directors on August 12, 2008. He remained an
employee of the company until August 31, 2008 and provided consulting services
to us for the remainder of the year. Other compensation for Mr. Palmin
represents salary and bonus he received in his capacity as director of Russian
relations for the Company and consulting fees paid to him for the months of
September through December.
|
(1)
|
As
of December 31, 2008, outstanding options to purchase common stock held by
directors were as follows: Dr. Hill 270,000; Mr. Doyle 270,000;
Dr. Fass 270,000; Dr. Manuso 220,000; Mr. McWilliams 322,778; Mr.
Schneider 170,000.
|
|
(2)
|
As
of December 31, 2008, Mr. Palmin held 300,000 options to purchase common
stock. In addition, The Liberty Irrevocable Trust 2008, a trust
for which his wife Alla is sole trustee, held 170,000 options to purchase
common stock. The total of 470,000 options had been granted to
Mr. Palmin during 2004 and 2005 in his capacity as chairman and chief
executive officer.
|
|
(3)
|
Director
fees include all fees earned for director services including quarterly
fees, meeting fees and committee chairman
fees.
|
|
(4)
|
The
fair value of each stock award was estimated on the grant date using the
Black-Scholes option-pricing model. See Note 6 to the financial
statements for a description of the assumptions used in estimating the
fair value of stock options.
|
During
2008, we paid our non-employee directors a cash fee of $5,000 per
quarter. The non-employee directors also received a fee of $1,500 for
any board or committee meeting attended and $750 for each telephonic board or
committee meeting in which the director participated. We also paid
our chairman an additional annual fee in the amount of $15,000, each
non-employee director who serves as the chair of the audit committee an
additional annual fee of $10,000 and each non-employee director who serves as
the chairman of the compensation and nominating and corporate governance
committees an additional annual fee of $5,000. We reimbursed
directors for reasonable out-of-pocket expenses incurred in attending board and
committee meetings and undertaking certain matters on our
behalf. Directors who are our employees do not receive separate fees
for their services as directors. There has been no change to cash
fees payable to non-employee directors for 2009.
During
2008, each non-employee director received an annual stock option grant of 40,000
shares of our common stock at the closing price of our common stock on the first
trading day of the fiscal year. On December 15, 2008, options to
purchase 80,000 shares of our common stock were granted for 2009 to each of our
non-employee directors at the closing price of our common stock on that day.
Both of these option grants vest on a quarterly basis over a two-year
period.
37
Equity
compensation plans
The
following table provides information as of December 31, 2008 regarding shares
authorized for issuance under our equity compensation plans, including
individual compensation arrangements.
We have
two equity compensation plans approved by our stockholders: the 2000
Stock Option and Incentive Plan and the 2006 Stock Incentive Plan. We
have also issued options to our directors and consultants that were not approved
by our stockholders. These options are exercisable within a ten-year
period from the date of the grant and vest at various intervals with all options
being fully vested within three years of the date of grant. The
option price per share is not less than the fair market value of our common
stock on the date of grant.
Equity
compensation plan information
|
Plan category
|
Number of shares to
be issued upon
exercise of outstanding
options, warrants and
rights (#)
|
Weighted-average
exercise price of
outstanding options,
warrants and rights
($)
|
Number of shares
remaining available for
future issuance under
equity compensation plans
(excluding shares reflected
in column (a)) (#)
|
|||||||||
|
(a)
|
(b)
|
(c)
|
||||||||||
|
Equity
compensation plans approved by stockholders
|
4,826,047 | $ | 0.61 | 230,000 | ||||||||
|
Equity
compensation plans not approved by stockholders
|
2,453,778 | $ | 0.57 | 0 | ||||||||
|
Total
|
7,279,825 | $ | 0.60 | 230,000 | ||||||||
38
SECURITY
OWNERSHIP OF CERTAIN
BENEFICIAL
OWNERS AND MANAGEMENT
At the
close of business on April 20, 2009, there were issued and outstanding
43,975,656 shares of our common stock. The following table provides information
regarding beneficial ownership of our common stock as of April 20,
2009:
|
|
·
|
Each
person known by us to be the beneficial owner of more than five percent of
our common stock;
|
|
|
·
|
Each
of our directors;
|
|
|
·
|
Each
executive officer named in the summary compensation table;
and
|
|
|
·
|
All
of our current directors and executive officers as a
group.
|
The
address of each executive officer and director is c/o Novelos Therapeutics,
Inc., One Gateway Center, Suite 504, Newton, Massachusetts 02458. The
persons named in this table have sole voting and investment power with respect
to the shares listed, except as otherwise indicated. The inclusion of
shares listed as beneficially owned does not constitute an admission of
beneficial ownership. Shares included in the “Right to Acquire”
column consist of shares that may be purchased through the exercise of options
that vest within 60 days of April 20, 2009.
|
Shares Beneficially Owned (3)
|
||||||||||||||||
|
Name and Address of Beneficial Owner
|
Outstanding
|
Right to Acquire
|
Total
|
Percentage
|
||||||||||||
|
CRE
Fiduciary Services, Inc.
as Trustee of the CRE
Trust
2120 Carey Avenue
Cheyenne, WY 82001
|
4,615,384 | - | 4,615,384 | 10.5 | % | |||||||||||
|
Liberty
Irrevocable Trust 2008 (1)
99-60
Florence Street, Apt. 4A
Chestnut
Hill, MA 02467
|
1,975,481 | 470,000 | 2,445,481 | 5.5 | % | |||||||||||
|
Harry
S. Palmin (2)
|
641,118 | 903,796 | 1,544,914 | 3.4 | % | |||||||||||
|
Christopher
J. Pazoles
|
0 | 324,999 | 324,999 | * | ||||||||||||
|
Kristin
C. Schuhwerk
|
0 | 191,666 | 191,666 | * | ||||||||||||
|
Stephen
A. Hill
|
0 | 166,250 | 166,250 | * | ||||||||||||
|
Michael
J. Doyle
|
0 | 185,000 | 185,000 | * | ||||||||||||
|
Sim
Fass
|
0 | 185,000 | 185,000 | * | ||||||||||||
|
James
S. Manuso
|
0 | 122,500 | 122,500 | * | ||||||||||||
|
David
B. McWilliams
|
0 | 237,778 | 237,778 | * | ||||||||||||
|
Howard
M. Schneider
|
100,000 | 85,000 | 85,000 | * | ||||||||||||
|
All
directors and officers as a group (11 persons)
|
741,118 | 2,621,988 | 3,363,106 | 7.2 | % | |||||||||||
____________________________
|
*
|
Less
than one percent.
|
|
(1)
|
Shares
outstanding include 236,542 shares owned by Alla Palmin, trustee of the
Liberty Irrevocable Trust2008. Shares in the “Right to Acquire” column
include 300,000 options to purchase common stock held by Simyon Palmin, a
founder of Novelos, a director until August 15, 2008, the father of Harry
Palmin and husband of Alla
Palmin.
|
|
(2)
|
Shares
owned by H. Palmin include 94,000 shares owned by his wife, Deanna
Palmin.
|
39
|
(5)
|
The
terms of our Series E preferred stock and common stock purchase warrants
issued to the holders of Series E preferred stock provide that the number
of shares of common stock to be obtained by each of the holders of Series
E preferred stock and common stock purchase warrants, upon conversion of
the Series E preferred stock or exercise of the 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% or 9.99%, as
applicable in the certificate of designations and warrant agreement, of
our outstanding common stock, provided, however that this limitation may
be revoked by the stockholder upon 61 days prior notice to us. For this
reason, holders of our Series E preferred stock who might otherwise have
the right to acquire 5% or more of our common stock have been omitted from
this table. Such limitations do not apply in the event of automatic
conversion of Series E preferred stock. Similar blocking
provisions apply to outstanding shares of our Series C preferred stock and
common stock purchase warrants issued to the holders of Series C preferred
stock and therefore holders of our Series C preferred stock who might
otherwise have the right to acquire 5% or more of our common stock have
also been omitted from this
table.
|
Pro
Forma Holdings Upon Automatic
Conversion
of Series E Preferred Stock
The
following table illustrates the pro forma beneficial ownership of our common
stock that would result in the event of an automatic conversion of all of the
outstanding shares of our Series E preferred stock into common
stock. All outstanding shares of Series E preferred stock
automatically convert in the event the volume weighted average price of our
common stock, calculated in accordance with the terms of the Series E preferred
stock, exceeds $2.00 for 20 consecutive trading days, provided there is an
effective registration statement covering the resale of the shares of common
stock so issuable. At the current conversion price of $0.65, the
automatic conversion of all outstanding shares of Series E preferred stock would
result in the issuance of 49,649,445 shares of common stock. In the
table below, share holdings have been presented in total for groups of
associated funds or companies. Such presentation is not intended to
represent that such funds or companies are under common control.
|
Name and Address of Beneficial Owner
|
Outstanding
|
Issuable upon
automatic
conversion of Series
E preferred stock
|
Total pro
forma
ownership
(1)
|
Pro forma
ownership
percentage
(2)
|
||||||||||||
|
Xmark
affiliated funds (3)
|
||||||||||||||||
|
90
Grove Street
|
||||||||||||||||
|
Ridgefield,
CT 06877
|
0 | 9,082,045 | 9,082,845 | 9.7 | % | |||||||||||
|
Orbimed
affiliated funds (4)
|
||||||||||||||||
|
767
Third Avenue, 30th
Floor
|
||||||||||||||||
|
New
York, NY 10017
|
0 | 10,878,150 | 10,878,150 | 11.6 | % | |||||||||||
|
Knoll
affiliated funds (5)
|
||||||||||||||||
|
666
Fifth Avenue, Suite 3702
|
||||||||||||||||
|
New
York, NY 10103
|
1,677,785 | 9,247,776 | 10,925,561 | 11.7 | % | |||||||||||
|
Hunt
Bioventures
|
||||||||||||||||
|
1900
N. Akard Street
|
||||||||||||||||
|
Dallas,
TX 75201
|
0 | 5,056,860 | 5,056,860 | 5.4 | % | |||||||||||
40
|
Name and Address of Beneficial Owner
|
Outstanding
|
Issuable upon
Automatic
conversion of Series
E preferred stock
|
Total pro
Forma
Ownership
(1)
|
Pro forma
Ownership
Percentage
(2)
|
||||||||||||
|
Purdue
Pharma, L.P. (6)
|
||||||||||||||||
|
One
Stamford Forum
|
||||||||||||||||
|
201
Tresser Blvd.
|
||||||||||||||||
|
Stamford,
CT 06901-3431
|
0 | 15,384,614 | 15,384,614 | 16.4 | % | |||||||||||
|
(1)
|
Pro
forma ownership does not include 21,096,150 shares of common stock
issuable upon exercise of outstanding warrants, due to the effect of the
blocker provisions described in Note 3 of the preceding
table.
|
|
(2)
|
Based
on 93,625,101 shares of common stock outstanding, which reflects the
number of shares of common stock outstanding as of March 20, 2009, plus
the total number of shares issuable upon conversion of all of the
outstanding shares of Series E preferred
stock.
|
|
(3)
|
Includes
Xmark Opportunity Partners LLC, Xmark Opportunity Fund, Ltd., Xmark
Opportunity Fund, L.P., Xmark JV Investment Partners,
LLC.
|
|
(4)
|
Includes
Orbimed Advisors LLC, Caduceus Capital Master Fund Limited, Caduceus
Capital II, LP, UBS Eucalyptus Fund, L.L.C., PW Eucalyptus Fund, Ltd., and
Summer Street Life Sciences Investors
LLC.
|
|
(5)
|
Includes
Knoll Capital, Knoll Special Opportunities Fund II Master Fund, Ltd.,
Europa International, Inc.
|
|
(6)
|
On
February 12, 2009, Purdue Pharma L.P. transferred its shares of Series E
Preferred Stock and warrants to purchase common stock of Novelos to Beacon
Company and Rosebay Medical Company L.P., which are independent associated
companies of Purdue Pharma L.P.
|
41
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
We are
obligated to ZAO BAM under a royalty and technology transfer agreement. Mark
Balazovsky, one of our directors until November 2006, is the majority
shareholder of ZAO BAM. Pursuant to the royalty and technology transfer
agreement between Novelos and ZAO BAM, we are required to make royalty payments
of 1.2% of net sales of oxidized glutathione-based products. We are also
required to pay ZAO BAM $2 million for each new oxidized glutathione-based drug
within eighteen months following FDA approval of such drug.
If a
royalty is not being paid to ZAO BAM on net sales of oxidized glutathione
products, then we are required to pay ZAO BAM 3% of all license
revenues. If license revenues exceed our cumulative expenditures
including, but not limited to, preclinical and clinical studies, testing, FDA
and other regulatory agency submission and approval costs, general and
administrative costs, and patent expenses, then the Company would be required to
pay ZAO BAM an additional 9% of the amount by which license revenues exceed the
Company’s cumulative expenditures. During 2008, we paid ZAO BAM
$15,000, which was 3% of license payments received under the collaboration
agreement with Lee’s Pharma, described in Note 5 to the financial
statements.
As a
result of the assignment to Novelos of the exclusive worldwide intellectual
property and marketing rights of oxidized glutathione (excluding Russia and the
other states of the former Soviet Union), Novelos is obligated to the Oxford
Group, Ltd. for future royalties. Simyon Palmin, a founder of
Novelos, a director until August 15, 2008 and the father of the Company’s
president and chief executive officer, is president of Oxford Group,
Ltd. Mr. Palmin was also an employee of the Company and is now a
consultant to the Company. Pursuant to the agreement, as revised May
26, 2005, Novelos is required to pay Oxford Group, Ltd. a royalty in the amount
of 0.8% of the Company’s net sales of oxidized glutathione-based
products.
Director
Independence
Each
member of the Audit Committee, the Compensation Committee and the Nominating and
Corporate Governance Committee meets the independence requirements of the Nasdaq
Stock Market for membership on the committees on which he serves. The board of
directors considered the information included in transactions with related
parties as outlined above along with other information the board considered
relevant, when considering the independence of each director. Harry S. Palmin is
not an independent director.
PRIVATE
PLACEMENTS OF CONVERTIBLE PREFERRED STOCK AND WARRANTS
On May 2,
2007, pursuant to a securities purchase agreement dated April 12, 2007, as
amended on May 2, 2007, we sold 300 shares of a newly created series of
preferred stock, designated “Series B Convertible Preferred Stock”, with a
stated value of $50,000 per share (the “Series B Preferred Stock”) and issued
warrants to purchase 7,500,000 shares of common stock to the selling
stockholders for an aggregate purchase price of $15,000,000 (the “Series B
Financing”). The shares of Series B Preferred Stock issued to the investors were
initially convertible into shares of common stock at $1.00 per share at any time
after issuance, at the option of the holder. If all the shares of Series B
Preferred Stock were converted following closing, a total of 15,000,000 shares
of common stock would have been issued.
On April
11, 2008, pursuant to a securities purchase agreement dated March 26, 2008, as
amended on April 9, 2008, we sold 113.5 shares of our “Series D Convertible
Preferred Stock”, with a stated value of $50,000 per share (the
“Series D Preferred Stock”), and issued warrants to purchase up to 4,365,381
shares of common stock (the “Series D Financing”) to the selling stockholders.
If all of these shares of Series D Preferred Stock were converted following the
closing, a total of 8,730,755 shares of common stock would have been
issued.
Upon the
closing of the Series D Financing, the holders of our Series B Preferred Stock
exchanged all 300 shares of their Series B Preferred Stock for 300 shares of
Series D Preferred Stock. Following the exchange, no shares of Series B
Preferred Stock remained outstanding. The rights and preferences of the Series D
Preferred Stock were substantially the same as the Series B Preferred Stock, but
the conversion price of the Series D Preferred Stock was $0.65. As a result of
the reduced conversion price, Series B Preferred Stock that was convertible into
15,000,000 shares of common stock was exchanged for shares of Series D Preferred
Stock convertible into 23,076,900 shares of common stock. If all outstanding
shares of Series D Preferred Stock were converted following the closing, a total
of 31,807,655 shares of common stock would have been issued.
42
On
February 11, 2009, we sold 200 shares of our “Series E Convertible Preferred
Stock”, with a stated value of $50,000 per share (the “Series E
Preferred Stock”), and issued warrants to purchase up to 9,230,769 shares of
common stock (the “Series E Financing”) to Purdue Pharma L.P.
(“Purdue”). The 200 shares of Series E Preferred Stock held by Purdue
are convertible into 15,384,615 shares of common stock.
Upon the
closing of the Series E Financing, the holders of our Series D Preferred Stock
exchanged all 413.5 shares of their Series D Preferred Stock and accrued
dividends thereon for 445.442875 shares of Series E Preferred Stock, convertible
into 34,264,831 shares of common stock. Following the exchange, no shares of
Series D Preferred Stock are outstanding. The rights and preferences of the
Series E Preferred Stock are substantially the same as the Series D Preferred
Stock. The exchange was completed principally so that the rights of
Purdue would be substantially the same as the rights of the holders of the
Series D Preferred Stock prior to the exchange.
Common
Stock Purchase Warrants
In
connection with the Series D Financing, we issued five-year warrants to purchase
an aggregate of 4,365,381 shares of our common stock for an aggregate purchase
price of $5,675,000 (the “Series D Warrants”). The Series D Warrants have an
exercise price of $0.65 per share and initially expired in April
2013.
In
connection with the Series B Financing, we issued warrants to purchase an
aggregate of 7,500,000 shares of our common stock (the “Series B Warrants”). The
Series B warrants had an initial exercise price of $1.25 per share and expired
in May 2012. In connection with the Series D Financing, the terms of the Series
B warrants were amended to conform the terms of the Series B Warrants to the
Series D Warrants. The Series B Warrants as amended have an exercise price of
$0.65 per share and were scheduled to expire in April 2013.
Both the
Series B Warrants and the Series D Warrants provided that, if there is an
effective registration statement covering the shares underlying the warrants and
the VWAP, as defined in the warrants, of our common stock exceeds $2.50 for 20
consecutive trading days, then on the 31 st day
following the end of such period any remaining warrants for which a notice of
exercise was not delivered shall no longer be exercisable and shall be converted
into a right to receive $.01 per share.
In
connection with the Series E financing, the Series B Warrants and the Series D
Warrants were amended to extend the expiration to December 31, 2015 and remove
the automatic exercise provision.
Registration
Rights Agreements
In
connection with the Series B Financing, we entered into a registration rights
agreement that required us to file with the SEC no later than June 1, 2007, a
registration statement covering the resale of 23,400,000 shares of common stock
(i.e. 100% of the shares of common stock issuable upon conversion of the Series
B Preferred Stock and exercise of the related warrants). We filed a registration
statement covering 23,400,000 shares of common stock on May 25, 2007. After
discussion with the SEC, the registration statement was amended to cover only
12,000,000 shares of common stock issuable upon conversion of 240 shares of the
Series B Preferred Stock. The holders of Series B Preferred Stock (i) consented
to the reduction of shares being covered by the registration statement from
23,400,000 to 12,000,000, (ii) agreed to extend the date by which the
registration statement must be declared effective from August 30, 2007 to
September 7, 2007 and (iii) waived, through September 7, 2007, any liquidated
damages arising as a result of the reduction in the number of shares being
registered and by the failure to have the registration statement declared
effective by August 30, 2007. The SEC declared this registration statement
effective on September 6, 2007.
43
On April
11, 2008 in connection with the closing of the Series D Financing, the holders
of Series B Preferred Stock waived any and all liquidated damages arising under
the registration rights agreement during the period from September 7, 2007
through the closing of the Series D Financing as a result of our failure to
register 100% of the shares of common stock issuable upon conversion of the
Series B Preferred Stock and exercise of the related warrants. In addition, we
entered into an amendment to the above described registration rights agreement
with the holders of our Series B Preferred Stock to (i) revise the definition of
registrable securities under the agreement to only include the 12,000,000 shares
of common stock that are included on a the registration statement that became
effective on September 6, 2007, (ii) clarify that our registration obligations
survive the exchange of Series B Preferred Stock for Series D Preferred Stock
and (iii) extend our registration obligations under the registration rights
agreement by one year. Under the amended registration rights agreement, we are
required to use our best efforts to keep the registration statement continuously
effective under the Securities Act until the earlier of the date when all the
registrable securities covered by the registration statement have been sold or
the third anniversary of the closing. We are allowed to suspend the use of the
registration statement for not more than 15 consecutive days or for a total of
not more than 30 days in any 12-month period without incurring liability for the
liquidated damages in certain circumstances.
In
connection with the Series D Financing, we entered into a registration rights
agreement (the “2008 Registration Rights Agreement”)with the investors (the
“Series D Investors”) which requires us to file with the SEC no later than 5
business days following the six-month anniversary of the closing of the Series D
Financing, a registration statement covering the resale of (i) a number of
shares of common stock equal to 100% of the shares issuable upon conversion of
the Series D Preferred Stock (excluding 12,000,000 shares of common stock
issuable upon conversion of the Series D Preferred Stock that are included on a
prior registration statement), (ii) 4,365,381 shares of common stock issuable
upon exercise of the Series D Warrants and (iii) 7,500,000 shares of common
stock issuable upon exercise of the Series B Warrants. This
registration rights agreement provided for the payment of liquidated damages in
the event that the registration statement was not filed by the time specified.
That registration statement was not filed.
In
connection with the Series E Financing, the Series D Investors waived all
damages that had accrued through February 11, 2009 as a result of our failure to
file the registration statement. Also, simultaneous with the closing
of the Series E Financing we entered into a new registration rights agreement
with Purdue and the Series D Investors. This agreement replaced the
2008 Registration Rights Agreement and requires us to file with the
Securities and Exchange Commission no later than 5 business days following the
six-month anniversary of the closing of the Series E Financing, a registration
statement covering the resale of (i) a number of shares of common stock equal to
100% of the shares issuable upon conversion of the Series E Preferred Stock
(excluding 12,000,000 shares of common stock included in this registration
statement), (ii) 9,230,769 shares of common stock issuable upon exercise of the
warrants issued to Purdue and (iii) 11,865,381 shares of common stock issuable
upon exercise of warrants held by the Series D Investors. We are required to use
our best efforts to have the registration statement declared effective and to
keep the registration statement continuously effective under the Securities Act
until the earlier of the date when all the registrable securities covered by the
registration statement have been sold or until February 11, 2011. In
the event that we fail to file the registration statement within the timeframe
specified, we will be required to pay to Purdue and the Series D Investors
liquidated damages equal to 1.5% per month (pro-rated on a daily basis for any
period of less than a full month) of the aggregate purchase price of the Series
E Preferred Stock and warrants until the delinquent registration statement is
filed. We will be allowed to suspend the use of the registration
statement for not more than 15 consecutive days or for a total of not more than
30 days in any 12 month period.
Placement
Agent
Upon the
closing of the Series B Financing we paid a placement agent fee to Rodman &
Renshaw LLC (“Rodman”) and Rodman’s subagent, Emerging Growth Equities, Ltd., in
cash in the amount of $1,050,000 and issued Rodman and the subagent warrants to
purchase 765,000 and 135,000 shares of common stock, respectively, having the
same terms as the warrants issued to the investors. This placement agent fee was
made in accordance with a letter agreement dated February 12, 2007 between us
and Rodman. We also agreed to indemnify Rodman from claims arising in relation
to the services it provided to us in connection with the Letter Agreement.
Following the closing of the Series D Financing we paid Rodman a cash fee of
$100,000.
44
Relationships
with the Selling Stockholders
Except as
described above under the caption “Private Placements of Convertible Preferred
Stock and Warrants”, none of the selling stockholders had any material
relationship with us within the past three years.
Selling
Stockholders Table
Based on
the information supplied to us by each selling stockholder, the following table
sets forth the approximate number of shares beneficially owned as of April
20, 2009 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 and convertible preferred stock that may
be exercised or converted within 60 days after April 20, 2009. The “Shares
Offered” column reflects all of the shares that each selling stockholder may
offer under this prospectus. Percentage ownership is based on 43,975,656 shares
issued and outstanding as of April 20, 2009. The table assumes that the
selling stockholders sell all of the shares.
We
prepared the table below based on information supplied to us by the selling
stockholders. Although we have assumed for purposes of the table that the
selling stockholders will sell all of the shares offered by this prospectus,
because the selling stockholders may offer from time to time all or some of
their shares covered under this prospectus, or in another permitted manner, no
assurances can be given as to the actual number of shares that will be resold by
the selling stockholders or that will be held by the selling stockholders after
completion of the resales.
The terms
of the Series E certificate of designations and common stock purchase warrants
provide that the number of shares to be obtained by each of the holders of
Series E preferred stock and warrants, upon conversion of Series D preferred
stock or 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% or 9.99%, as applicable, 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. Such limitations do not
apply in the event of automatic conversion of Series E preferred
stock. For purposes of the table below, we have disregarded these
blocking provisions.
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 and in the footnotes to the selling stockholders table and
except for the ownership of our preferred stock and common stock purchase
warrants, none of the selling stockholders had any material relationship with us
within the past three years.
45
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
|
|||||||||||||||
|
Xmark
Opportunity Fund, Ltd.
|
0
|
6,110,253
|
6,110,253
|
1,600,000
|
0
|
4,510,253
|
9.3
|
|||||||||||||||
|
Xmark
Opportunity Fund, L.P.
|
0
|
3,055,126
|
3,055,126
|
800,000
|
0
|
2,255,126
|
4.9
|
|||||||||||||||
|
Xmark
JV Investment Partners, LLC
|
0
|
3,055,126
|
3,055,126
|
800,000
|
0
|
2,255,126
|
4.9
|
|||||||||||||||
|
Caduceus
Capital Master Fund Limited
|
0
|
5,746,272
|
5,746,272
|
1,600,000
|
0
|
4,146,272
|
8.6
|
|||||||||||||||
|
Caduceus
Capital II, L.P.
|
0
|
4,402,375
|
4,402,375
|
1,040,000
|
0
|
3,362,375
|
7.1
|
|||||||||||||||
|
UBS
Eucalyptus Fund, L.L.C.
|
0
|
2,946,452
|
2,946,452
|
1,040,000
|
0
|
1,906,452
|
4.2
|
|||||||||||||||
|
PW
Eucalyptus Fund, Ltd.
|
0
|
339,974
|
339,974
|
120,000
|
0
|
219,974
|
*
|
|||||||||||||||
|
Knoll
Special Opportunities Fund II Master Fund, Ltd.(1)
|
268,485
|
5,503,619
|
5,772,104
|
1,600,000
|
268,485
|
3,903,619
|
8.7
|
|||||||||||||||
|
Europa
International, Inc. (1)
|
1,409,300
|
6,959,541
|
8,368,841
|
1,600,000
|
1,409,300
|
5,359,541
|
13.7
|
|||||||||||||||
|
Hunt
BioVentures, L.P.
|
0
|
6,798,206
|
6,798,206
|
1,800,000
|
0
|
4,998,206
|
10.2
|
|||||||||||||||
* Less
than 1%
|
(1)
|
Shares in the “Outstanding”
column consist of shares purchased in market transactions following the
closing of the sale of Series B Preferred
Stock.
|
Voting
and Investment Control
The table
below sets forth selling stockholders that are entities and the names of
individuals having voting and investment control over the securities held by
these entities. We determined beneficial ownership based upon information
supplied to us by the selling stockholders and in accordance with rules
promulgated by the Securities and Exchange Commission, and the information is
not necessarily indicative of beneficial ownership for any other purpose. The
inclusion of shares listed as beneficially owned does not constitute an
admission of beneficial ownership. Except as otherwise indicated, we believe
that the persons or entities named in the following table have voting and
investment power with respect to all shares of common stock shown as
beneficially owned by them, subject to community property laws where applicable,
and have not held any office or maintained any material relationship, except as
investor or as described above, with us, or any of our predecessors or
affiliates, over the past three years. Certain of the individuals with voting
and investment control have indicated that they exercise such control through a
corporate or other organizational structure, which structural information has
not been included.
The
following entities have informed us that the following individuals have voting
and investment control over our securities held by them:
|
Entity
|
Voting
and Investment Control
|
|
|
Xmark
Opportunity Fund, Ltd.
|
Mitchell
Kaye and David Cavalier
|
|
|
Xmark
Opportunity Fund, L.P.
|
Mitchell
Kaye and David Cavalier
|
|
|
Xmark
JV Investment Partners, LLC
|
Mitchell
Kaye and David Cavalier
|
|
|
Caduceus
Capital Master Fund Limited
|
Samuel
D. Isaly
|
|
|
Caduceus
Capital II, L.P.
|
Samuel
D. Isaly
|
|
|
UBS
Eucalyptus Fund, L.L.C.
|
Samuel
D. Isaly
|
|
|
PW
Eucalyptus Fund, Ltd.
|
Samuel
D. Isaly
|
|
|
Knoll Special
Opportunities Fund II Master Fund, Ltd.
|
Fred
Knoll, KOM Capital Management as Investment Manager for Knoll Special
Opportunities Fund II Master Fund, Ltd.
|
|
|
Europa
International, Inc.
|
Fred
Knoll, Knoll Capital Management as Investment Manager for Europa
International Inc.
|
|
|
Hunt
BioVentures, L.P.
|
Christopher
W. Kleinert
|
|
|
Xmark
JV Investment Partners, LLC
|
Mitchell
Kaye and David
Cavalier
|
46
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 20, 2009, we had
designated 272 shares of Series C cumulative convertible preferred
stock, all of which were issued and outstanding as of that date and 735 shares
of Series E convertible preferred stock, 645.442875 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.
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 had 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 E preferred stock (with respect to the
current fiscal year and all prior fiscal years) shall have been paid to the
holders of the Series E preferred stock. Such dividends shall be paid in
cash.
47
Conversion: Each share of
Series C preferred stock is currently convertible at a price of $0.65 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 E 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 E preferred stock as may be required) on a pro
rata basis.
Series
E Convertible Preferred Stock
Stated Value: The Series E
preferred stock has a stated value of $50,000 per share.
Voting and Board Rights: The
Series E 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 E preferred stock is entitled is equal to the number of shares
of common stock that would be issued to such holder if the Series E Preferred
Stock had been converted at the record date for the meeting of stockholders,
subject to the limitations described under the subcaption “Conversion”
below.
Pursuant
to the Securities Purchase Agreement dated March 26, 2008, Xmark Opportunity
Fund, Ltd. and its affiliates (the “Xmark Entities”), has 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 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”) 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
preferred stock issued to them. Pursuant to a Securities Purchase
Agreement dated February 11, 2009, Purdue Pharma, L.P. (“Purdue”) has 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 no longer hold at least
one-half of the preferred stock issued to them.
48
Dividends: The Series E
preferred stock has a dividend rate of 9% per annum, payable semi-annually. Such
dividends may be paid in cash, in shares of Series E preferred stock or in
registered shares of common stock. While any shares of Series E 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 E holders. If consent is given,
the holders of outstanding shares of Series E preferred stock are also entitled
to participate in any dividends paid to common stockholders.
Conversion: Each share of
Series E preferred stock is convertible at a price of $0.65 per common share at
any time after issuance. The Series E preferred stock can be converted only to
the extent that the Series E 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 E preferred stock and
the daily volume weighted average price (“VWAP”), as defined in the Series E
Certificate of Designations, of our common stock exceeds $2.00 for 20
consecutive trading days, then the outstanding Series E 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 E preferred stock will be equivalent to the
conversion rights of the Series E preferred stock stockholders prior to such
event.
Liquidation: The Series E
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 SeriesE 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 E Preferred Stock
are not sufficient to permit the payment in full, then all our assets will be
distributed to the holders of our Series E 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 E Preferred Stock) acquires more than 50% of
our outstanding stock, then the holders of Series E 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.
Other restrictions: For as long as any
shares of Series E Preferred Stock remain outstanding, without the prior consent
of the Requisite Holders of Series E preferred stock (as defined), 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 E Preferred Stock (except
for certain exempted issuances); (iv) increasing the number of shares of Series
E Preferred Stock or issuing any additional shares of Series E Preferred Stock
other than the shares designated in the Series E 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 E
Preferred Stock remains outstanding and there are no changes to the rights and
preferences of the Series E Preferred Stock; (vi) redeeming or repurchasing any
capital stock other than Series E 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.
49
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.
PLAN
OF DISTRIBUTION
The
selling stockholders, which as used herein includes donees, pledgees,
transferees or other successors-in-interest selling shares of common stock or
interests in shares of common stock received after the date of this prospectus
from a selling stockholder as a gift, pledge, partnership distribution or other
transfer, may, from time to time, sell, transfer or otherwise dispose of any or
all of their shares of common stock or interests in shares of common stock on
any stock exchange, market or trading facility on which the shares are traded or
in private transactions. These dispositions may be at fixed prices, at
prevailing market prices at the time of sale, at prices related to the
prevailing market price, at varying prices determined at the time of sale, or at
negotiated prices.
The
selling stockholders may use any one or more of the following methods when
disposing of shares or interests therein:
|
·
|
ordinary brokerage transactions
and transactions in which the broker-dealer solicits
purchasers;
|
50
|
·
|
block trades in which the
broker-dealer will attempt to sell the shares as agent, but may position
and resell a portion of the block as principal to facilitate the
transaction;
|
|
·
|
purchases by a broker-dealer as
principal and resale by the broker-dealer for its
account;
|
|
·
|
an exchange distribution in
accordance with the rules of the applicable
exchange;
|
|
·
|
privately negotiated
transactions;
|
|
·
|
short
sales;
|
|
·
|
through the writing or settlement
of options or other hedging transactions, whether through an options
exchange or otherwise;
|
|
·
|
broker-dealers may agree with the
selling stockholders to sell a specified number of such shares at a
stipulated price per share;
|
|
·
|
a combination of any such methods
of sale; and
|
|
·
|
any other method permitted
pursuant to applicable law.
|
The
selling stockholders may, from time to time, pledge or grant a security interest
in some or all of the shares of common stock owned by them and, if they default
in the performance of their secured obligations, the pledgees or secured parties
may offer and sell the shares of common stock, from time to time, under this
prospectus, or under an amendment to this prospectus under Rule 424(b)(3) or
other applicable provision of the Securities Act amending the list of selling
stockholders to include the pledgee, transferee or other successors in interest
as selling stockholders under this prospectus. The selling stockholders also may
transfer the shares of common stock in other circumstances, in which case the
transferees, pledgees or other successors in interest will be the selling
beneficial owners for purposes of this prospectus.
In
connection with the sale of our common stock or interests therein, the selling
stockholders may enter into hedging transactions with broker-dealers or other
financial institutions, which may in turn engage in short sales of the common
stock in the course of hedging the positions they assume. The selling
stockholders may also sell shares of our common stock short and deliver these
securities to close out their short positions, or loan or pledge the common
stock to broker-dealers that in turn may sell these securities. The selling
stockholders may also enter into option or other transactions with
broker-dealers or other financial institutions or the creation of one or more
derivative securities which require the delivery to such broker-dealer or other
financial institution of shares offered by this prospectus, which shares such
broker-dealer or other financial institution may resell pursuant to this
prospectus (as supplemented or amended to reflect such
transaction).
The
aggregate proceeds to the selling stockholders from the sale of the common stock
offered by them will be the purchase price of the common stock less discounts or
commissions, if any. Each of the selling stockholders reserves the right to
accept and, together with their agents from time to time, to reject, in whole or
in part, any proposed purchase of common stock to be made directly or through
agents. We will not receive any of the proceeds from this offering. Upon any
exercise of the warrants by payment of cash, however, we will receive the
exercise price of the warrants.
The
selling stockholders also may resell all or a portion of the shares in open
market transactions in reliance upon Rule 144 under the Securities Act of 1933,
provided that they meet the criteria and conform to the requirements of that
rule.
51
The
selling stockholders and any underwriters, broker-dealers or agents that
participate in the sale of the common stock or interests therein may be
"underwriters" within the meaning of Section 2(11) of the Securities Act. Any
discounts, commissions, concessions or profit they earn on any resale of the
shares may be underwriting discounts and commissions under the Securities Act.
Selling stockholders who are "underwriters" within the meaning of Section 2(11)
of the Securities Act will be subject to the prospectus delivery requirements of
the Securities Act.
To the
extent required, the shares of our common stock to be sold, the names of the
selling stockholders, the respective purchase prices and public offering prices,
the names of any agents, dealer or underwriter, any applicable commissions or
discounts with respect to a particular offer will be set forth in an
accompanying prospectus supplement or, if appropriate, a post-effective
amendment to the registration statement that includes this
prospectus.
In order
to comply with the securities laws of some states, if applicable, the common
stock may be sold in these jurisdictions only through registered or licensed
brokers or dealers. In addition, in some states the common stock may not be sold
unless it has been registered or qualified for sale or an exemption from
registration or qualification requirements is available and is complied
with.
We have
advised the selling stockholders that the anti-manipulation rules of Regulation
M under the Exchange Act may apply to sales of shares in the market and to the
activities of the selling stockholders and their affiliates. In addition, we
will make copies of this prospectus (as it may be supplemented or amended from
time to time) available to the selling stockholders for the purpose of
satisfying the prospectus delivery requirements of the Securities Act. The
selling stockholders may indemnify any broker-dealer that participates in
transactions involving the sale of the shares against certain liabilities,
including liabilities arising under the Securities Act.
We have
agreed to indemnify the selling stockholders against liabilities, including
liabilities under the Securities Act and state securities laws, relating to the
registration of the shares offered by this prospectus.
We have
agreed with the selling stockholders to keep the registration statement of which
this prospectus constitutes a part effective until the earlier of (1) such time
as all of the shares covered by this prospectus have been disposed of pursuant
to and in accordance with the registration statement or (2) until May 2,
2010.
DISCLOSURE
OF COMMISSION POSITION ON
INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
Our
charter contains provisions to indemnify our directors and officers to the
maximum extent permitted by Delaware law. We believe that indemnification under
our charter covers at least negligence on the part of an indemnified person. Our
charter permits us to advance expenses incurred by an indemnified person in
connection with the defense of any action or proceeding arising out of the
person’s status or service as our director, officer, employee or other agent
upon an undertaking by the person to repay those advances if it is ultimately
determined that the person is not entitled to indemnification.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may
be permitted to directors, officers and controlling persons of the small
business issuer pursuant to the foregoing provisions, or otherwise, the small
business issuer has been advised that in the opinion of the Securities and
Exchange Commission such indemnification is against public policy as expressed
in the Securities Act of 1933 and is, therefore, unenforceable.
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.
52
This
prospectus is part of a registration statement on Form SB-2 that we filed with
the SEC. Certain information in the registration statement has been omitted from
this prospectus in accordance with the rules and regulations of the SEC. We have
also filed exhibits and schedules with the registration statement that are
excluded from this prospectus. For further information you may:
|
·
|
read a copy of the registration
statement, including the exhibits and schedules, without charge at the
SEC’s Public Reference Room;
or
|
|
·
|
obtain a copy from the SEC upon
payment of the fees prescribed by the
SEC.
|
LEGAL
MATTERS
The
validity of the securities being offered by this prospectus has been passed upon
for us by Foley Hoag LLP, Boston, Massachusetts.
EXPERTS
Stowe
& Degon LLC have audited our financial statements as of December 31, 2008
and 2007 and for the years then ended. The financial statements referred to
above are included in this prospectus with reliance upon the independent
registered public accounting firm’s opinion based on its expertise in accounting
and auditing.
53
FINANCIAL
STATEMENTS
INDEX
TO FINANCIAL STATEMENTS FOR NOVELOS THERAPEUTICS, INC.
|
Page
|
||
|
Report
of Independent Registered Public Accounting Firm
|
F-2
|
|
|
Balance
Sheets at December 31, 2008 and 2007
|
F-3
|
|
|
Statements
of Operations for the Years Ended December 31, 2008 and
2007
|
F-4
|
|
|
Statements
of Redeemable Preferred Stock and Stockholders’ Deficiency for the Years
Ended December 31, 2008 and 2007
|
F-5
|
|
|
Statements
of Cash Flows for the Years Ended December 31, 2008 and
2007
|
F-6
|
|
|
Notes
to Financial Statements
|
F-7
|
F-1
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the
Stockholders and Board of Directors
Novelos
Therapeutics, Inc.
Newton,
Massachusetts
We have
audited the accompanying balance sheets of Novelos Therapeutics, Inc. as of
December 31, 2008 and 2007 and the related statements of operations, redeemable
preferred stock and stockholders’ deficiency, and cash flows for the years then
ended. These financial statements are the responsibility of the Company’s
management. Our responsibility is to express an opinion on these financial
statements based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audits to obtain reasonable assurance about whether the
financial statements are free of material misstatement. The Company is not
required to have, nor were we engaged to perform, an audit of its internal
control over financial reporting. Our audit included consideration of internal
control over financial reporting as a basis for designing audit procedures that
are appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company’s internal control over financial
reporting. Accordingly we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our
opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of Novelos Therapeutics, Inc. as of
December 31, 2008 and 2007 and the results of its operations, changes in
stockholders’ deficiency, and cash flows for the years then ended in conformity
with accounting principles generally accepted in the United States.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. As discussed in Note 1 to the
financial statements, the Company has incurred continuing losses in the
development of its products and has a stockholders’ deficiency at December 31,
2008. These factors raise substantial doubt about the Company’s ability to
continue as a going concern. Management’s plans in this regard are
described in Note 1. The financial statements do not include any
adjustments that might result from the outcome of this
uncertainty.
/s/ Stowe
& Degon LLC
Westborough,
Massachusetts
March 17,
2009
F-2
NOVELOS
THERAPEUTICS, INC.
BALANCE
SHEETS
|
December
31,
|
December
31,
|
|||||||
|
2008
|
2007
|
|||||||
|
ASSETS
|
||||||||
|
CURRENT
ASSETS:
|
||||||||
|
Cash
and equivalents
|
$ | 1,262,452 | $ | 9,741,518 | ||||
|
Restricted
cash
|
— | 1,184,702 | ||||||
|
Prepaid
expenses and other current assets
|
129,785 | 133,281 | ||||||
|
Total
current assets
|
1,392,237 | 11,059,501 | ||||||
|
FIXED
ASSETS, NET
|
58,451 | 32,809 | ||||||
|
DEPOSITS
|
15,350 | 15,350 | ||||||
|
TOTAL
ASSETS
|
$ | 1,466,038 | $ | 11,107,660 | ||||
|
LIABILITIES,
REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIENCY
|
||||||||
|
CURRENT
LIABILITIES:
|
||||||||
|
Accounts
payable and accrued liabilities
|
$ | 4,653,912 | $ | 6,372,478 | ||||
|
Accrued
compensation
|
240,639 | 349,412 | ||||||
|
Accrued
dividends
|
1,689,322 | 337,500 | ||||||
|
Deferred
revenue – current
|
33,333 | — | ||||||
|
Total
current liabilities
|
6,617,206 | 7,059,390 | ||||||
|
DEFERRED
REVENUE – NONCURRENT
|
433,333 | — | ||||||
|
COMMITMENTS
AND CONTINGENCIES
|
||||||||
|
REDEEMABLE
PREFERRED STOCK:
|
||||||||
|
Series
D convertible preferred stock, $0.00001 par value; 420 shares designated;
413.5 shares issued and outstanding at December 31, 2008 (liquidation
preference $22,070,562) (Note 4)
|
13,904,100 | — | ||||||
|
Series
B convertible preferred stock, $0.00001 par value; 400 shares designated;
300 shares issued and outstanding at December 31, 2007 (Note
4)
|
— | 9,918,666 | ||||||
| 13,904,100 | 9,918,666 | |||||||
|
STOCKHOLDERS’
DEFICIENCY:
|
||||||||
|
Preferred
stock, $0.00001 par value; Series C 8% cumulative convertible preferred
stock; 272 shares issued and outstanding at December 31, 2008 and 2007
(liquidation preference $3,557,760 and $3,264,000 at December 31, 2008 and
2007, respectively) (Note 4)
|
— | — | ||||||
|
Common
stock, $0.00001 par value; 150,000,000 shares authorized; 43,975,656
shares issued and outstanding at December 31, 2008; 39,260,272 shares
issued and outstanding at December 31, 2007
|
440 | 392 | ||||||
|
Additional
paid-in capital
|
40,204,112 | 37,370,959 | ||||||
|
Accumulated
deficit
|
(59,693,153 | ) | (43,241,747 | ) | ||||
|
Total
stockholders’ deficiency
|
(19,488,601 | ) | (5,870,396 | ) | ||||
|
TOTAL
LIABILITIES, REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’
DEFICIENCY
|
$ | 1,466,038 | $ | 11,107,660 | ||||
See
notes to financial statements.
F-3
NOVELOS
THERAPEUTICS, INC.
STATEMENTS
OF OPERATIONS
|
Year
Ended December 31,
|
||||||||
|
2008
|
2007
|
|||||||
|
REVENUE
|
$ | 125,968 | $ | — | ||||
|
COSTS
AND EXPENSES:
|
||||||||
|
Research
and development
|
14,526,619 | 17,427,804 | ||||||
|
General
and administrative
|
2,190,366 | 2,866,383 | ||||||
|
Total
costs and expenses
|
16,716,985 | 20,294,187 | ||||||
|
LOSS
FROM OPERATIONS
|
(16,591,017 | ) | (20,294,187 | ) | ||||
|
OTHER
INCOME:
|
||||||||
|
Interest
income
|
130,611 | 729,922 | ||||||
|
Miscellaneous
|
9,000 | 7,130 | ||||||
|
Total
other income
|
139,611 | 737,052 | ||||||
|
NET
LOSS
|
(16,451,406 | ) | (19,557,135 | ) | ||||
|
PREFERRED
STOCK DIVIDENDS
|
(2,092,102 | ) | (1,161,120 | ) | ||||
|
PREFERRED
STOCK DEEMED DIVIDENDS
|
(4,417,315 | ) | (9,003,083 | ) | ||||
|
NET
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
$ | (22,960,823 | ) | $ | (29,721,338 | ) | ||
|
BASIC
AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON
SHARE
|
$ | (0.56 | ) | $ | (0.76 | ) | ||
|
WEIGHTED
AVERAGE SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS ATTRIBUTABLE
TO COMMON STOCKHOLDERS PER COMMON SHARE
|
41,100,883 | 39,247,532 | ||||||
See
notes to financial statements.
F-4
NOVELOS
THERAPEUTICS, INC.
STATEMENTS
OF REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIENCY
|
REDEEMABLE
PREFERRED STOCK
Series B and D
Convertible Preferred
Stock
|
Common Stock
|
Series A
Cumulative
Convertible
Preferred Stock
|
Series C
Cumulative
Convertible
Preferred Stock
|
Additional
Paid-in
Capital
|
Accumulated
Deficit
|
Total
Stockholders’
Equity
(Deficiency)
|
||||||||||||||||||||||||||||||||||||||
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
|||||||||||||||||||||||||||||||||||||
|
BALANCE
AT JANUARY 1, 2007
|
— | $ | — | 39,235,272 | $ | 392 | 3,264 | $ | — | — | $ | — | $ | 34,294,154 | $ | (23,684,612 | ) | $ | 10,609,934 | |||||||||||||||||||||||||
|
Exercise
of stock options
|
— | — | 25,000 | — | — | — | — | — | 250 | — | 250 | |||||||||||||||||||||||||||||||||
|
Compensation
expense associated with options issued to employees
|
— | — | — | — | — | — | — | — | 343,233 | — | 343,233 | |||||||||||||||||||||||||||||||||
|
Compensation
expense associated with options issued to non-employees
|
— | — | — | — | — | — | — | — | 160,057 | — | 160,057 | |||||||||||||||||||||||||||||||||
|
Issuance
of Series B redeemable convertible preferred stock and warrants, net of
issuance costs of $1,306,949
|
300 | 17,743,051 | — | — | — | — | — | — | 3,774,385 | — | 3,774,385 | |||||||||||||||||||||||||||||||||
|
Beneficial
conversion feature on Series B redeemable convertible preferred
stock
|
— | (7,824,385 | ) | — | — | — | — | — | — | 7,824,385 | — | 7,824,385 | ||||||||||||||||||||||||||||||||
|
Deemed
dividend related to the accretion of beneficial conversion feature on
Series B redeemable convertible preferred stock
|
— | — | — | — | — | — | — | — | (7,824,385 | ) | — | (7,824,385 | ) | |||||||||||||||||||||||||||||||
|
Retirement
of Series A preferred stock and issuance of Series C preferred
stock
|
— | — | — | — | (3,264 | ) | — | 272 | — | — | — | — | ||||||||||||||||||||||||||||||||
|
Issuance
of common stock purchase warrants in connection with exchange of preferred
stock
|
— | — | — | — | — | — | — | — | 1,138,698 | — | 1,138,698 | |||||||||||||||||||||||||||||||||
|
Deemed
dividend recorded in connection with exchange of Series A for Series C
convertible preferred stock
|
— | — | — | — | — | — | — | — | (1,178,698 | ) | — | (1,178,698 | ) | |||||||||||||||||||||||||||||||
|
Dividends
paid on preferred stock
|
— | — | — | — | — | — | — | — | (823,620 | ) | — | (823,620 | ) | |||||||||||||||||||||||||||||||
|
Dividends
accrued on preferred stock
|
— | — | — | — | — | — | — | — | (337,500 | ) | — | (337,500 | ) | |||||||||||||||||||||||||||||||
|
Net
loss
|
— | — | — | — | — | — | — | — | — | (19,557,135 | ) | (19,557,135 | ) | |||||||||||||||||||||||||||||||
|
BALANCE
AT DECEMBER 31, 2007
|
300 | 9,918,666 | 39,260,272 | 392 | — | — | 272 | — | 37,370,959 | (43,241,747 | ) | (5,870,396 | ) | |||||||||||||||||||||||||||||||
|
Exercise
of stock options
|
— | — | 100,000 | 1 | — | — | — | — | 999 | — | 1,000 | |||||||||||||||||||||||||||||||||
|
Compensation
expense associated with options issued to employees
|
— | — | — | — | — | — | — | — | 395,194 | — | 395,194 | |||||||||||||||||||||||||||||||||
|
Compensation
expense associated with options issued to non-employees
|
— | — | — | — | — | — | — | — | 58,133 | — | 58,133 | |||||||||||||||||||||||||||||||||
|
Issuance
of common stock in a private placement
|
4,615,384 | 47 | 2,986,691 | — | 2,986,738 | |||||||||||||||||||||||||||||||||||||||
|
Issuance
of Series D redeemable convertible preferred stock and warrants, net of
issuance costs of $205,328
|
113.5 | 4,167,080 | — | — | — | — | — | — | 1,302,592 | — | 1,302,592 | |||||||||||||||||||||||||||||||||
|
Adjustment
to record the carrying value of Series D redeemable convertible preferred
stock at market value on the date of sale
|
— | (181,646 | ) | — | — | — | — | — | — | 181,646 | — | 181,646 | ||||||||||||||||||||||||||||||||
|
Fair
value of reduction in conversion and exercise price of Series B redeemable
convertible preferred stock and warrants
|
— | 3,876,912 | — | — | — | — | — | — | 722,049 | — | 722,049 | |||||||||||||||||||||||||||||||||
|
Accretion
of deemed dividend associated with the reduction of conversion and
exercise
prices on Series B redeemable convertible preferred stock
and warrants
|
— | (3,876,912 | ) | — | — | — | — | — | — | (722,049 | ) | — | (722,049 | ) | ||||||||||||||||||||||||||||||
|
Dividends
paid on preferred stock
|
— | — | — | — | — | — | — | — | (402,780 | ) | — | (402,780 | ) | |||||||||||||||||||||||||||||||
|
Dividends
accrued on preferred stock
|
— | — | — | — | — | — | — | — | (1,689,322 | ) | — | (1,689,322 | ) | |||||||||||||||||||||||||||||||
|
Net
loss
|
— | — | — | — | — | — | — | — | — | (16,451,406 | ) | (16,451,406 | ) | |||||||||||||||||||||||||||||||
|
BALANCE
AT DECEMBER 31, 2008
|
413.5 | $ | 13,904,100 | 43,975,656 | $ | 440 | — | $ | — | 272 | $ | — | $ | 40,204,112 | $ | (59,693,153 | ) | $ | (19,488,601 | ) | ||||||||||||||||||||||||
See
notes to financial statements.
F-5
NOVELOS
THERAPEUTICS, INC.
STATEMENTS
OF CASH FLOWS
|
Year
Ended December 31,
|
||||||||
|
2008
|
2007
|
|||||||
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
|
Net
loss
|
$ | (16,451,406 | ) | $ | (19,557,135 | ) | ||
|
Adjustments
to reconcile net loss to cash used in operating
activities:
|
||||||||
|
Depreciation
and amortization
|
16,889 | 15,367 | ||||||
|
Loss
on disposal of fixed assets
|
6,472 | — | ||||||
|
Stock-based
compensation
|
453,327 | 503,290 | ||||||
|
Change
in:
|
||||||||
|
Prepaid
expenses and other current assets
|
3,496 | 161,714 | ||||||
|
Accounts
payable and accrued liabilities
|
(1,718,566 | ) | 5,284,437 | |||||
|
Accrued
compensation
|
(108,773 | ) | 124,028 | |||||
|
Deferred
revenue
|
466,666 | — | ||||||
|
Cash
used in operating activities
|
(17,331,895 | ) | (13,468,299 | ) | ||||
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
|
Purchases
of fixed assets
|
(49,003 | ) | (24,366 | ) | ||||
|
Change
in restricted cash
|
1,184,702 | 470,549 | ||||||
|
Deposits
|
— | (4,475 | ) | |||||
|
Cash
provided by investing activities
|
1,135,699 | 441,708 | ||||||
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
|
Proceeds
from issuance of common stock, net
|
2,986,738 | — | ||||||
|
Proceeds
from issuance of Series B convertible preferred stock, net
|
— | 13,693,051 | ||||||
|
Proceeds
from issuance of Series D convertible preferred stock, net
|
5,469,672 | — | ||||||
|
Dividends
paid to preferred stockholders
|
(740,280 | ) | (823,620 | ) | ||||
|
Payment
to preferred stockholders in connection with exchange of shares
(1)
|
— | (40,000 | ) | |||||
|
Proceeds
from exercise of stock option
|
1,000 | 250 | ||||||
|
Cash
provided by financing activities
|
7,717,130 | 12,829,681 | ||||||
|
DECREASE
IN CASH AND EQUIVALENTS
|
(8,479,066 | ) | (196,910 | ) | ||||
|
CASH
AND EQUIVALENTS AT BEGINNING OF YEAR
|
9,741,518 | 9,938,428 | ||||||
|
CASH
AND EQUIVALENTS AT END OF YEAR
|
$ | 1,262,452 | $ | 9,741,518 | ||||
|
SUPPLEMENTAL
DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES
|
||||||||
|
Deemed
dividends on preferred stock
|
$ | 4,417,315 | $ | 8,963,083 | ||||
|
Dividends
accrued but not paid to preferred stockholders
|
$ | 1,689,322 | $ | 337,500 | ||||
|
Issuance
of warrants to preferred stockholders
|
$ | 1,302,592 | $ | 3,774,385 | ||||
|
Issuance
of warrants to placement agents
|
$ | — | $ | 768,621 | ||||
|
Exchange
of Series B for Series D preferred stock
|
$ | 9,918,666 | $ | — | ||||
(1)
Included as a deemed dividend in the Statement of Operations.
See
notes to financial statements.
F-6
NOVELOS
THERAPEUTICS, INC.
NOTES
TO FINANCIAL STATEMENTS
1.
NATURE OF BUSINESS, ORGANIZATION AND GOING CONCERN
Novelos
Therapeutics, Inc. (‘‘Novelos’’ or the ‘‘Company’’) is a drug
development company focused on the development of therapeutics for the treatment
of cancer and hepatitis. Novelos owns exclusive worldwide
intellectual property rights (excluding Russia and other states of the former
Soviet Union) related to certain clinical compounds and other pre-clinical
compounds based on oxidized glutathione.
The
Company is subject to a number of risks similar to those of other companies in
an early stage of development. Principal among these risks are dependence on key
individuals, competition from substitute products and larger companies, the
successful development and marketing of its products in a highly regulated
environment and the need to obtain additional financing necessary to fund future
operations.
These
financial statements have been prepared on the basis that the Company will
continue as a going concern. The Company is devoting substantially
all of its efforts toward the research and development of its products and has
incurred operating losses since inception. The process of developing
products will continue to require significant research and development,
non-clinical testing, clinical trials and regulatory approval. The
Company expects that these activities, together with general and administrative
costs, will result in continuing operating losses for the foreseeable future.
The Company believes that it has adequate funds, including the proceeds from the
sale of preferred stock in February 2009, to continue operations into late 2009.
The Company’s ability to execute its operating plan beyond late 2009 is
dependent on its ability to obtain additional capital (including through the
sale of equity and debt securities and by entering into collaborative
arrangements for licensing rights in North America) to fund its development
activities. The Company plans to actively pursue these alternatives
during 2009, but there can be no assurance that it will obtain the additional
capital necessary to fund its business beyond the end of 2009. The
Company anticipates that the results from its Phase 3 clinical trial in
non-small cell lung cancer will be available in late 2009. The primary endpoint
of the trial is increased median overall survival, to be measured following the
occurrence of 725 events (deaths). The timing and content of those clinical
results may impact the Company’s projected cash requirements and its ability to
obtain capital. Furthermore, continuing difficult conditions in the
capital markets globally may adversely affect the ability of the Company to
obtain funding in a timely manner. The Company is continuously
evaluating measures to further reduce costs to preserve existing
capital. If the Company is unable to obtain sufficient additional
funding, it will be required, beginning in late 2009, to scale back its
administrative activities and clinical development programs including the Phase
3 clinical development of its lead drug candidate, NOV-002.
2. SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
The
accompanying financial statements reflect the application of certain accounting
policies, as described in this note and elsewhere in the accompanying notes to
the financial statements.
Use of Estimates
— The preparation of financial statements in conformity with accounting
principles generally accepted in the United States requires management to make
estimates and assumptions that affect the reported amounts of assets,
liabilities, revenue and expenses and disclosure of contingent assets and
liabilities. Management’s estimates are based primarily on relevant
historical experience and other assumptions that management believes to be
reasonable. Estimates include those for unbilled contract service
fees such as amounts due to clinical research organizations, clinical
investigators and contract manufacturers. Actual results could differ
from those estimates.
Cash
Equivalents — The Company considers all short-term investments purchased
with original maturities of three months or less to be cash
equivalents.
Restricted Cash
— Restricted cash at December 31, 2007 consisted of cash pledged as
security on a letter of credit agreement with a bank. The letter of credit
expired in 2008.
Fixed Assets
— Property and equipment are stated at cost. Depreciation on property and
equipment is provided using the straight-line method over the estimated useful
lives of the assets, which range from three to five years. Leasehold
improvements are depreciated over the lesser of the estimated useful lives of
the assets or the remaining lease term.
Impairment of
Long-Lived
Assets — Whenever events or circumstances change, the Company assesses
whether there has been an impairment in the value of long-lived assets by
determining whether projected undiscounted cash flows generated by the
applicable asset exceed its net book value as of the assessment date. There were
no impairments of the Company’s assets at the end of each period
presented.
Stock-based
Compensation — The Company applies the
fair-value recognition provisions of Statement of Financial Accounting Standards
(SFAS) No. 123(R), Share-Based
Payment (SFAS 123R) in accounting for stock-based
compensation. The Company accounts
for share-based payments granted to non-employees in accordance with
Emerging Issues Task Force (EITF) No. 96-18, Accounting for Equity Instruments
That Are Issued to Other Than Employees for Acquiring, or in Conjunction with
Selling, Goods or Services. See Note 6 for a further
description of the Company’s accounting policies related to stock-based
compensation.
F-7
Revenue
Recognition — Revenue is recognized when persuasive evidence of an
arrangement exists, the price is fixed and determinable, delivery has occurred,
and there is reasonable assurance of collection. Upfront payments received in
connection with technology license or collaboration agreements are recognized
over the estimated term of the related agreement. Milestone payments received in
connection with license or collaboration agreements are recognized upon
completion of the applicable milestones, provided that there are no further
delivery obligations associated with the milestone. Royalty revenue will be
recognized upon the receipt of royalty reports from third parties.
Research and
Development — Research and development costs are expensed as
incurred.
Income
Taxes — The Company uses the liability method of accounting for income
taxes. Under this method, deferred tax assets and liabilities are
determined based on temporary differences between financial statement and tax
basis of assets and liabilities and net operating loss and credit carryforwards
using enacted tax rates in effect for the year in which the differences are
expected to reverse. The effect on deferred tax assets and
liabilities of a change in tax rates is recognized in income in the period that
includes the enactment date. Valuation allowances are established
when it is more likely than not that some portion of the deferred tax assets
will not be realized.
The
Company adopted FIN 48, “Accounting for Uncertainty in Income
Taxes – an Interpretation of FASB Statement No. 109”, on the first day of
its 2007 fiscal year. The implementation had no effect on the
Company’s reported financial position or results of operations in the year ended
December 31, 2008.
Comprehensive
Income (Loss) — The Company had no components of comprehensive income
other than net loss in all of the periods presented.
Fair Value of
Financial Instruments — SFAS No. 107, Disclosures About Fair Value of
Financial Instruments, requires disclosure of the fair value of certain
financial instruments. The Company’s financial instruments consist of
cash equivalents, accounts payable, accrued expenses and redeemable preferred
stock. The estimated fair value of the redeemable preferred stock,
determined on an as-converted basis, was $14,950,000 and $8,850,000 at December
31, 2008 and 2007, respectively. The estimated fair value of the remaining
financial instruments approximates their carrying value due to their short-term
nature.
Concentration of
Credit Risk — Financial instruments that subject the Company to credit
risk consist of cash and equivalents on deposit with financial
institutions. The Company’s excess cash is invested on an overnight
basis in securities that are fully collateralized. When funds are not
invested overnight, cash is on deposit in a non-interest-bearing transaction
account that is fully covered by FDIC deposit insurance until December 31,
2009.
New Accounting
Pronouncements — In June 2008 the Emerging Issues Task Force reached a
consensus on Issue No. 07-5 Determining Whether an Instrument
(or Embedded Feature) is Indexed to an Entity’s Own Stock (EITF 07-5).
EITF 07-5 establishes a framework for determining whether certain freestanding
and embedded instruments are indexed to a company’s own stock for purposes of
evaluation of the accounting for such instruments under existing accounting
literature. EITF 07-5 is effective for fiscal years beginning after December 15,
2008. The Company is currently evaluating the impact of this standard on its
financial statements and anticipates that effective January 1, 2009, the fair
value of certain outstanding warrants containing anti-dilution provisions,
issued in 2005 and 2006, will be required to be reclassified from equity to a
liability and revalued on a quarterly basis, with changes in fair value
recognized as a component of earnings or loss.
In
December 2007 the Emerging Issues Task Force reached a consensus on Issue No.
07-1 Accounting for
Collaborative Arrangements (EITF 07-1). EITF 07-1 defines collaborative
arrangements and establishes reporting requirements for transactions between
participants in a collaborative arrangement and between participants in the
arrangement and third parties. EITF 07-1 is effective for fiscal years beginning
after December 15, 2008. The Company is currently evaluating the impact of this
standard on its financial statements and related disclosures.
In June
2007, the Emerging Issues Task Force reached a consensus on Issue No. 07-3 Accounting for Nonrefundable Advance
Payments for Goods or Services Received for Use in Future Research and
Development Activities (EITF 07-3). EITF 07-3 requires that nonrefundable
advance payments for goods or services used or rendered for future research and
development activities be deferred and capitalized and subsequently recognized
as an expense as the goods are delivered or the related services are
performed. EITF 07-3 is effective for fiscal years beginning after
December 15, 2007 and interim periods within those fiscal years with no earlier
application permitted. This standard had no effect on the Company’s
reported financial position or results of operations in the year ended December
31, 2008.
In
February 2007, the Financial Accounting Standards Board (FASB) issued SFAS No.
159, The Fair Value Option for
Financial Assets and Financial Liabilities – Including an Amendment to FASB
Statement No. 115 (SFAS 159). SFAS 159 permits entities to
choose to measure many financial instruments and certain other items at fair
value. SFAS 159 is effective for financial statements issued for
fiscal years beginning after November 15, 2007. This standard had no
effect on the Company’s reported financial position or results of operations in
the year ended December 31, 2008.
F-8
3.
FIXED ASSETS
Fixed
assets consisted of the following at December 31:
|
2008
|
2007
|
|||||||
|
Office
and computer equipment
|
$ | 73,261 | $ | 51,652 | ||||
|
Computer
software
|
25,896 | 7,896 | ||||||
|
Leasehold
improvements
|
4,095 | 4,095 | ||||||
|
Total
fixed assets
|
103,252 | 63,643 | ||||||
|
Less
accumulated depreciation and amortization
|
(44,801 | ) | (30,834 | ) | ||||
|
Fixed
assets, net
|
$ | 58,451 | $ | 32,809 | ||||
4.
STOCKHOLDERS’ EQUITY (DEFICIENCY)
2005 Issuance of Common Stock –
From May
27, 2005 through August 9, 2005, the Company completed a private offering of
securities, exempt from registration under the Securities Act of 1933, in which
it sold to accredited investors 4,000,000 shares of common stock and issued
2,000,000 common stock warrants (initially exercisable at $2.25 per share) for
net cash proceeds of approximately $3,715,000 (net of cash issuance costs of
approximately $735,000) and conversion of debt and accrued interest of
$550,000. In connection with the private placement, the Company also
issued 125,000 shares of common stock to placement agents with a value of
approximately $156,000 and issued 340,000 common stock warrants to placement
agents and finders at an initial exercise price of $2.00 per
share. Pursuant to anti-dilution provisions, the number of warrants
issued to investors, placement agents and finders as well as the exercise price
of the warrants have changed. On August 11, 2008, warrants to
purchase 6,923,028 shares of preferred stock at an exercise price of $.65 per
share expired unexercised. These warrants were issued in 2005 to the
purchasers of shares of common stock. At December 31, 2008, warrants
to purchase 1,046,143 shares of common stock at an exercise price of $0.65 per
share held by placement agents remain outstanding.
Issuance of
Series
A
Preferred
Stock –
On
September 30, 2005 and October 3, 2005, the Company sold, in a private
placement, a total of 3,200 shares of its Series A 8% Cumulative Convertible
Preferred Stock (“Series A Preferred Stock”) with a stated value of $1,000 per
share and 969,696 common stock warrants for net proceeds of $2,864,000, net of
issuance costs of $336,000. See “Issuance of Series C Preferred
Stock” below for a description of the exchange of Series A Preferred Stock that
occurred in May 2007. The warrants issued in connection with the sale
of Series A Preferred Stock had anti-dilution provisions that provided for
adjustments to the exercise price upon the occurrence of certain events.
Pursuant to these anti-dilution provisions the exercise price of the warrants
was subsequently adjusted and as of December 31, 2008, the warrants are
exercisable at $0.65 per share.
2006 Issuance of
Common Stock –
On March
7, 2006, the Company completed a private offering of securities, exempt from
registration under the Securities Act of 1933, in which it sold to accredited
investors 11,154,073 shares of common stock at $1.35 per share and warrants to
purchase 8,365,542 shares of its common stock exercisable at $2.50 per share for
net cash proceeds of approximately $13,847,000 (net of issuance costs of
approximately $1,211,000, including placement agent fees of approximately
$1,054,000). In connection with the private placement, the Company
issued 669,244 common stock warrants (exercisable at $2.50 per share) to the
placement agents. Pursuant to anti-dilution provisions, as a result of
subsequent financings, as of December 31, 2008, the number of shares of common
stock issuable upon exercise of the warrants issued to investors and placement
agents was 11,267,480 and the exercise price was $2.00 per
share. On February 11, 2009, the number and exercise price of the warrants
was adjusted further. See Note 10.
Issuance of Series B
Preferred
Stock
–
On May 2, 2007,
pursuant to a securities purchase agreement with accredited investors dated
April 12, 2007 (the “Purchase Agreement”), as amended May 2, 2007, the Company
sold 300 shares of a newly created series of preferred stock, designated “Series
B Convertible Preferred Stock”, with a stated value of $50,000 per share (the
“Series B Preferred Stock”), and issued warrants (the “Series B Warrants”) to
purchase 7,500,000 shares of common stock for an aggregate purchase price of
$15,000,000. The Series B Preferred Stock was initially convertible
into 15,000,000 shares of common stock at $1.00 per share. During
2008, the Company declared and paid $675,000 in dividends to Series B
stockholders ($2,250 per share). During 2007, the Company declared dividends
totaling $900,000 ($3,000 per share) to Series B preferred stockholders;
$562,500 ($1,875 per share) of that amount was paid in cash during
2007. See “Issuance of Series D Preferred Stock” below for a
description of the exchange of Series B Preferred Stock that occurred on April
11, 2008.
The
common stock purchase warrants issued to these purchasers are exercisable for an
aggregate of 7,500,000 shares of the Company’s common stock at an initial
exercise price of $1.25 per share and had an initial expiration date of May
2012. The warrant exercise price and/or number of warrants is subject
to adjustment only for stock dividends, stock splits or similar capital
reorganizations so that the rights of the warrant holders after such event will
be equivalent to the rights of warrant holders prior to such
event. If there is an effective registration statement covering the
shares underlying the warrants and the volume weighted average price (“VWAP”),
as defined in the warrant, of the Company’s common stock exceeds $2.50 for 20
consecutive trading days, then on the 31st day
following the end of such period any remaining warrants for which a notice of
exercise was not delivered will no longer be exercisable and will be converted
into a right to receive $.01 per share. See “Issuance of Series D
Preferred Stock” and Note 10 below for descriptions of amendments to the Series
B Warrants that were executed on April 11, 2008 and February 11,
2009.
F-9
The
Company and these purchasers entered into a registration rights agreement in
connection with the closing of the sale of the Series B Preferred
Stock. The registration rights agreement was subsequently amended on
April 11, 2008 and on February 11, 2009. The agreement, as
amended, requires the Company to use its best efforts to keep a registration
statement covering 12,000,000 shares of common stock continuously effective
under the Securities Act until the earlier of the date when all securities
covered by the registration statement have been sold or the second anniversary
of the closing. In the event the Company does not fulfill the requirements of
the registration rights agreement, the Company is required to pay to the
investors liquidated damages equal to 1.5% per month of the aggregate purchase
price of the preferred stock and warrants until the requirements have been
met. The 12,000,000 shares of common stock were included on a
registration statement that became effective on April 28, 2008.
Upon the
closing of the Series B Preferred Stock financing the Company issued to
placement agents warrants to purchase a total of 900,000 shares of common stock
with the same terms as the warrants issued to the investors.
Issuance of
Series C
Preferred
Stock –
As a
condition to closing of the sale of Series B Preferred Stock described above,
the Company entered into an agreement to exchange and consent with the holders
of the Series A Preferred Stock providing for the exchange of all 3,264 shares
of Series A Preferred Stock for 272 shares of a new Series C convertible
preferred stock (“Series C Preferred Stock”), junior to the Series B Preferred
Stock as set forth in the Series C Preferred Stock Certificate of
Designations. The Series C Preferred Stock was initially convertible
at $1.00 per share into 3,264,000 shares of common stock. As part of
the exchange, the Company issued to the holders of the Series A Preferred Stock
warrants to purchase 1,333,333 shares of common stock expiring on May 2, 2012 at
a price of $1.25 per share; paid them a cash allowance to defray expenses
totaling $40,000; and paid them an amount of cash equal to unpaid dividends
accumulated through the date of the exchange. The fair value of the
warrants at the date of issuance calculated using the Black-Scholes valuation
method was $1,138,698. The valuation was based on estimated
volatility of 80%, a discount rate of 4.55%, and a term of 5
years. The total of the fair value of the warrants and the cash
payment of $40,000 has been reflected as a deemed dividend to preferred
stockholders in the statement of operations. Pursuant to the exchange
agreement, the holders of the Series C preferred stock retained registration and
related rights substantially identical to the rights that they had as holders of
the Series A Preferred Stock.
Terms
of the Series C Preferred Stock
The
Series C Preferred Stock had an annual dividend rate of 8% until October 1, 2008
and thereafter has an annual dividend rate of 20%. The dividends are
payable quarterly. Such dividends shall be paid only 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. During 2008, the Company paid $65,280
in dividends on Series C Preferred Stock ($240 per share). During
2007, the Company declared and paid dividends totaling $173,355 ($637 per share)
to Series C preferred stockholders. As of December 31, 2008, there were
accumulated unpaid dividends of $294,000 ($1,080 per share) on Series C
Preferred Stock. The conversion price is subject to adjustment for
stock dividends, stock splits or similar capital reorganizations. The
Series C Preferred Stock does not have voting rights and is redeemable only at
the option of the Company upon 30 days’ notice at a 20% premium plus any accrued
but unpaid dividends. In the event of any voluntary or involuntary
liquidation, dissolution or winding up of the Company’s affairs, the Series C
Preferred stock will be treated as senior to Novelos common
stock. After all required payments are made to holders of Series D
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 the Company’s affairs, the Company’s remaining assets
available to pay the holders of Series C preferred stock are not sufficient to
permit the payment in full, then all of the Company’s assets will be distributed
to the holders of Series C preferred stock (and any remaining holders of Series
D preferred stock as may be required) on a pro rata basis.
Adjustment
of Series C Preferred Stock Conversion Price
In
connection with the sale of Series D Preferred Stock described below, the
conversion price of the Series C Preferred Stock was reduced to $0.65 and became
convertible into 5,021,537 shares of common stock.
Issuance of Series D
Preferred Stock
–
On April
11, 2008, pursuant to a securities purchase agreement with accredited investors
dated March 26, 2008, as amended on April 9, 2008, the Company sold 113.5 shares
of Series D Convertible Preferred Stock, par value $0.00001 per share (the
“Series D Preferred Stock”) and issued warrants (the “Series D Warrants”) to
purchase 4,365,381 shares of its common stock for an aggregate purchase price of
$5,675,000 (the “Series D Financing”).
F-10
Exchange
of Series B Preferred Stock for Series D Preferred Stock
In
connection with the closing of the Series D Financing, the holders of the
Company’s Series B Preferred Stock, exchanged all 300 of their shares of Series
B Preferred Stock for 300 shares of Series D Preferred
Stock. Following the exchange, no shares of Series B Preferred Stock
are outstanding. The rights and preferences of the Series D Preferred
Stock are substantially the same as the Series B Preferred
Stock. However, the conversion price of the Series D Preferred Stock
is $0.65. In addition, the holders of Series B Preferred Stock waived
liquidated damages that had accrued from September 7, 2007 through the closing
date as a result of the Company’s failure to register for resale 100% of the
shares of common stock underlying the Series B Preferred Stock and
warrants. As a result, during 2008, the Company recorded a reduction
of general and administrative expenses of $395,000 relating to the reversal of
estimated liquidated damages that had been accrued through the date of the
closing. The purchase agreement covering the issuance and sale of the
Series D Preferred Stock provided that the dividends that accrued on the shares
of Series B Preferred Stock from April 1, 2008 through the date of exchange were
to be paid, out of legally available funds, on June 30, 2008. As of
June 30, September 30, and December 31, 2008 the Company did not have legally
available funds for the payment of dividends under Delaware corporate law and
therefore was not able to pay any dividends accrued in respect of the preferred
stock totaling $1,396,000 ($3,375 per share).
Terms
of Series D Preferred Stock
The
shares of Series D Preferred Stock are convertible into shares of common stock
any time after issuance at the option of the holder at $0.65 per share of common
stock. If there is an effective registration statement covering the
shares of common stock underlying the Series D Preferred Stock and the VWAP, as
defined in the Series D Certificate of Designations, of the Company’s 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. The conversion price will be subject to
adjustment for stock dividends, stock splits or similar capital
reorganizations.
The
holders of Series D Preferred Stock are entitled to vote on all matters on which
the holders of common stock are entitled to vote. Each holder of
Series D Preferred Stock is entitled to a number of votes equal to the number of
shares of common stock that would have been issued to such holder if the Series
D Preferred Stock had been converted at the record date for the meeting of
stockholders.
The
Series D Preferred Stock has an annual dividend rate of 9%, payable
semi-annually on June 30 and December 31. Such dividends may be paid
in cash or in registered shares of the Company’s common stock at the Company’s
option, subject to certain conditions.
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 the Company’s affairs. The Series D preferred
stockholders will be entitled to receive first, $50,000 per share and all
accrued and unpaid dividends. Subject to any distributions that are
required for any other series of preferred stock, the Series D preferred
stockholders are then entitled to participate with the holders of the common
stock in the distribution of remaining assets on a pro rata
basis. If, upon any winding up of the Company’s affairs, assets
available to pay the holders of Series D Preferred Stock are not sufficient to
permit the payment in full, then all assets will be distributed to the holders
of Series D Preferred Stock on a pro rata basis. If the Company
sells, leases or otherwise transfers substantially all of its assets,
consummates a business combination in which it is not the surviving corporation
or, if it is the surviving corporation, if the holders of a majority of the
common stock immediately before the transaction do not hold a majority of common
stock immediately after the transaction, in one or a series of events, change
the majority of the members of the board of directors, or if any person or
entity (other than the holders of Series D Preferred Stock) acquires more than
50% of the Company’s 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 the holders of
any other series of preferred or common stock in a distribution of the remaining
assets.
For as
long as any shares of Series D Preferred Stock remain outstanding, the Company
is prohibited from (i) paying dividends to its common stockholders, (ii)
amending its 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,
(v) selling or otherwise disposing of all or substantially all of its assets or
intellectual property or entering into a merger or consolidation with another
company unless the Company 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
directors. The Company is required to reserve, out of
authorized shares of common stock, 100% of the number of shares of common stock
into which Series D Preferred Stock is convertible.
Board
and Observer Rights
Pursuant
to the Series D Preferred Stock purchase agreement, from and after the closing,
Xmark Opportunity Fund, L.P., Xmark Opportunity Fund, Ltd. and Xmark JV
Investment Partners, LLC (collectively, the “Xmark Entities”), retained the
right to designate one member to the Company’s 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, Caduceus Master Fund Limited, Caduceus Capital II, L.P.,
Summer Street Life Sciences Hedge Fund Investors, LLC, UBS Eucalyptus Fund, LLC
and PW Eucalyptus Fund, Ltd. (collectively, the “Series D Lead Investors”) have
the right to designate one observer to attend all meetings of the Company’s
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 Series D Lead Investors no longer hold at least one-third of
the Series D Preferred Stock issued to them at closing. The rights to
designate a board member and board observer have not yet been
exercised.
F-11
Common
Stock Purchase Warrants
The
Series D Warrants are exercisable for an aggregate of 4,365,381 shares of the
Company’s common stock at an exercise price of $0.65 per share and expire in
April 2013. If after the six-month anniversary of the date of
issuance of the warrants there is no effective registration statement
registering, or no current prospectus available for, the resale of the shares
issuable upon the exercise of the warrants, the holder may conduct a cashless
exercise whereby the holder may elect to pay the exercise price by having the
Company withhold, upon exercise, shares having a fair market value equal to the
applicable aggregate exercise price. In the event of such a cashless
exercise, the Company would receive no proceeds from the sale of common stock in
connection with such exercise.
The
warrant exercise price and/or number of warrants is subject to adjustment only
for stock dividends, stock splits or similar capital reorganizations so that the
rights of the warrant holders after such event will be equivalent to the rights
of warrant holders prior to such event.
If there
is an effective registration statement covering the shares underlying the
warrants and the VWAP, as defined in the warrant, of the Company’s common stock
exceeds $2.50 for 20 consecutive trading days, then on the 31st day
following the end of such period any remaining warrants for which a notice of
exercise was not delivered shall no longer be exercisable and shall be converted
into a right to receive $.01 per share.
See Note
10 for a description of an amendment to Series D Warrants that was executed on
February 11, 2009.
Registration
Rights Agreement
The
Company entered into a registration rights agreement with these purchasers that
requires the Company to file with the Securities and Exchange Commission no
later than 5 business days following the six-month anniversary of the closing of
the Series D Financing, a registration statement covering the resale of (i) a
number of shares of common stock equal to 100% of the shares issuable upon
conversion of the Series D Preferred Stock (excluding 12,000,000 shares of
common stock issuable upon conversion of the Series D Preferred Stock that were
included on a prior registration statement), (ii) a number of shares of common
stock equal to 100% of the shares issuable upon exercise of the warrants issued
in the Series D Financing and (iii) 7,500,000 shares of common stock issuable
upon exercise of warrants dated May 2, 2007 held by the investors. The Company
is required to use its best efforts to have the registration statement declared
effective and keep the registration statement continuously effective under the
Securities Act until the earlier of the date when all the registrable securities
covered by the registration statement have been sold or the second anniversary
of the closing. In the event the Company fails to file the
registration statement within the timeframe specified by the Registration Rights
Agreement, the investors are entitled to receive liquidated damages equal to
1.5% per month (pro-rated on a daily basis for any period of less than a full
month) of the aggregate purchase price of the Series D Preferred Stock and
warrants until the Company files the delinquent registration
statement. The Company is allowed to suspend the use of the
registration statement for not more than 15 consecutive days or for a total of
not more than 30 days in any 12-month period. The registration
statement was required to be filed by October 18, 2008. As of December 31, 2008,
the registration statement had not been filed. However, the Company had not
concluded that it was probable that damages would become due. Therefore, no
accrual for damages has been recorded. In connection with a financing
that was completed on February 11, 2009, the damages from October 18, 2008
through February 11, 2009 under the Registration Rights Agreement were waived
and the Registration Rights Agreement was replaced with an agreement requiring
that a registration statement be filed in August 2009. See Note 10.
Placement
Agent Fee and Other Costs
Following
the closing of the Series D Financing, the Company paid Rodman & Renshaw LLC
a cash fee of $100,000 and paid other closing costs of approximately
$105,000.
Amendments
to Prior Warrants and Registration Rights Agreement
At the
closing, the Company entered into an amendment to the registration rights
agreement dated May 2, 2007 with the holders of its Series B Preferred Stock to
revise the definition of registrable securities under the agreement to include
only the 12,000,000 shares of common stock that were included on a prior
registration statement and to extend the registration obligations under the
agreement by one year. On April 28, 2008, the amended registration
statement covering the 12,000,000 shares of common stock required to be
registered was declared effective. Accordingly, the Company has not accrued any
liquidated damages at December 31, 2008 in connection with its registration
obligation under the agreement. If the Company is unable to maintain
the effectiveness of that registration statement through April 11, 2010, the
Company may become liable for liquidated damages in future periods.
In
addition, in connection with the closing, the warrants to purchase common stock
issued in connection with the sale of Series B Preferred Stock were amended to
conform the terms of those warrants to the terms of the warrants issued in the
Series D Financing.
F-12
Exchange
of Series D Preferred Stock for Series E Preferred Stock
On
February 11, 2009 all outstanding shares of Series D Preferred Stock and
accumulated dividends thereon were exchanged for shares of Series E preferred
stock. See Note 10.
Accounting
Treatment of Series B and Series D Preferred Stock
The terms
of the Series B Preferred Stock contained provisions that allow the holders to
elect to receive a liquidation payment in circumstances that are beyond the
Company’s control. Therefore the shares have been recorded as
redeemable preferred stock outside of permanent equity in the balance
sheet. The shares were initially recorded at their estimated
as-converted fair value of $19,050,000, net of cash issuance costs of
$1,306,949. That value was further reduced by the intrinsic value of
the beneficial conversion feature of $7,824,385. As a result of the
effective adjustment to the conversion price of preferred stock and the
adjustment to the exercise price of warrants that occurred in connection with
the exchange of all outstanding shares of Series B Preferred Stock for shares of
Series D Preferred Stock, in the quarter ended June 30, 2008, a deemed dividend
of $4,598,961 was recorded. This amount represents the incremental
fair value on the date of the exchange resulting from the adjustment to the
conversion price of the Series B Preferred Stock from $1.00 to $0.65
($3,876,912) and the exercise price of the warrants from $1.25 to $0.65
($722,049). These amounts were recorded as both debits and credits to
temporary and permanent equity, respectively, in the year ended December 31,
2008. The incremental fair value of the adjustment to the conversion
price of the Series B Preferred Stock was determined based on the market value
of the additional 8,076,900 shares of common stock that became issuable
following the exchange. The incremental fair value of the modification to the
warrants was the difference between the fair value of the warrants immediately
before and after modification using the Black-Scholes option pricing
model. The fair value of the warrants prior to modification was
calculated based on an estimated volatility of 80%, a discount rate of 2.34% and
a term of 4.08 years. The fair value of the warrants after the modification was
calculated based on an estimated volatility of 80%, a discount rate of 2.57% and
a term of 5 years.
Since the
terms of the Series D Preferred Stock also contain provisions that may require
redemption in circumstances that are beyond the Company’s control, the shares
have been recorded as redeemable preferred stock outside of permanent equity in
the balance sheet as of December 31, 2008. The gross proceeds of
$5,675,000 received in conjunction with the Series D Financing were allocated on
a relative fair-value basis between the Series D Preferred Stock and the
warrants. The relative fair-value of the Series D Warrants of
$1,302,592 was recorded as additional paid-in capital while the relative fair
value of the Series D Preferred Stock of $4,372,408 was recorded as temporary
equity. The carrying value of the Series D Preferred Stock was
immediately adjusted to its fair value of $4,190,762 based on the fair value of
the as-converted common stock. The difference of $181,646 was
recorded as a reduction to the deemed dividend described
above. Issuance costs related to the Series D Financing of $205,328
were netted against temporary equity. The total carrying value of
temporary equity at December 31, 2008 of $13,904,100 consists of the $9,918,666
carrying value of the Series B Preferred Stock on the date of exchange plus the
$3,985,434 carrying value of the Series D Preferred Stock issued in the Series D
Financing. The fair value of the Series D warrants was
calculated using the Black-Scholes pricing model with a volatility of 80%, a
discount rate of 2.57% and a term of 5 years.
Since the
Company has concluded it is not probable that an event will occur which would
allow the holders of Series D Preferred Stock to elect to receive a liquidation
payment, the carrying value will not be adjusted until the time that such event
becomes probable. The liquidation preference (redemption value) is $22,070,562
at December 31, 2008.
2008 Issuance of Common Stock
–
On August
15, 2008, the Company sold 4,615,384 shares of its common stock to two related
accredited investors for gross proceeds of approximately $3,000,000, pursuant to
a securities purchase agreement dated August 14, 2008.
The
Common Stock Purchase Agreement provides that on and after six months following
the closing, if there is not an available exemption from Rule 144 under the
Securities Act to permit the sale of the common stock by the purchasers, then
the Company will use its best efforts to file a registration statement (the
“Registration Statement”) under the Securities Act with the SEC covering the
resale of the common stock. It further provides that the Company will
use its best efforts to maintain the effectiveness of the Registration Statement
until one year from closing or until all the common stock has been sold or
transferred, whichever occurs first.
This
purchase agreement also provides that if, prior to the public announcement of
the conclusion of the Company’s NOV-002 Phase 3 clinical trial in non-small cell
lung cancer, the Company completes a Subsequent Equity Financing (as defined
therein) and the holders of shares of Series D Preferred Stock receive, as
consideration for their consent to such a financing, a reduction in
the effective conversion price or exercise price, as applicable, of the shares
of Series D Preferred Stock or common stock purchase warrants issued in
connection therewith, or additional shares of common stock, then the purchasers
will be entitled to receive additional shares of common stock based on the
formula detailed in the purchase agreement.
Common
Stock Warrants — The
following table summarizes information with regard to outstanding warrants
issued in connection with equity and debt financings as of December 31,
2008.
F-13
|
Offering
|
Outstanding
(as adjusted)
|
Exercise
Price
(as adjusted)
|
Expiration Date
|
||||||
|
2005
Bridge Loans
|
720,000 | $ | 0.625 |
April
1, 2010
|
|||||
|
2005
Issuance of Common Stock - Placement agents and finders
|
1,046,143 | $ | 0.65 |
August
9, 2010
|
|||||
|
Series
A Preferred Stock (1):
|
|||||||||
|
Purchasers
– September 30, 2005 closing
|
909,090 | $ | 0.65 |
September 30, 2010
|
|||||
|
Purchasers
– October 3, 2005 closing
|
60,606 | $ | 0.65 |
October
3, 2010
|
|||||
|
2006
Issuance of Common Stock – Purchasers and placement agents
(2)
|
11,267,480 | $ | 2.00 |
March
7, 2011
|
|||||
|
Series
B Preferred Stock:
|
|||||||||
|
Purchasers
|
7,500,000 | $ | 0.65 |
April
11, 2013
|
|||||
|
Placement
agents
|
900,000 | $ | 1.25 |
May
2, 2012
|
|||||
|
Series
C Exchange
|
1,333,333 | $ | 1.25 |
May
2, 2012
|
|||||
|
Series
D Preferred Stock
|
4,365,381 | $ | 0.65 |
April
11, 2013
|
|||||
|
Total
|
28,102,033 | ||||||||
(1) Concurrently
with the closing of the Series B Preferred Stock financing, all shares of Series
A Preferred Stock were exchanged for shares of Series C Preferred
Stock.
(2) In connection with the
financing described in Note 10 as a subsequent event, the number
of shares of common stock underlying warrants issued in connection
with the 2006 Issuance of Common Stock was increased to 12,379,848 and the
exercise price was decreased to $1.82.
No
warrants have been exercised as of December 31, 2008. On August 11,
2008, warrants to purchase 6,923,028 shares of common stock expired
unexercised.
Reserved Shares —
The following shares were reserved for future issuance upon exercise of stock
options or warrants or conversion of preferred stock as of the dates
indicated:
|
December 31,
|
||||||||
|
2008
|
2007
|
|||||||
|
2000
Stock Option Plan
|
56,047 | 73,873 | ||||||
|
2006
Stock Incentive Plan
|
4,770,000 | 2,220,000 | ||||||
|
Options
issued outside of formalized plans
|
2,453,778 | 2,553,778 | ||||||
|
Warrants
|
28,102,033 | 28,973,047 | (1) | |||||
|
Preferred
stock
|
36,829,192 | 22,014,000 | (1) | |||||
|
Total
shares reserved for future issuance
|
72,211,050 | 55,834,698 | ||||||
(1) The
amount of reserved shares includes shares reserved in excess of the number
currently exercisable or convertible in accordance with the related financing
agreements.
Authorized Shares — There is a total of
150,000,000 shares of common stock authorized for issuance.
5. 2007
COLLABORATION AGREEMENT
In
December 2007 the Company entered into a Collaboration Agreement with Lee’s
Pharmaceutical (HK) Ltd. (“Lee’s Pharma”). Pursuant to the agreement,
Lee’s Pharma obtained an exclusive license to develop, manufacture and
commercialize NOV-002 and NOV-205 in Hong Kong, Macau, China and Taiwan (the
“territory”). Under the terms of the agreement the Company received a
license fee of $500,000 in March 2008 and is entitled to receive up to
$1,700,000 in future milestone payments upon the completion of development and
marketing milestones by Lee’s Pharma. This initial $500,000 payment
received is being amortized over the estimated term of the agreement, 15
years. Accordingly, $33,334 of license revenue was recognized in the
year ended December 31, 2008.
The
Company will receive royalty payments of 20-25% of net sales of NOV-002 in the
territory and will receive royalty payments of 12-15% of net sales of NOV-205 in
the territory. Lee’s Pharma will also reimburse the Company for the
manufacturing cost of pharmaceutical products provided to Lee’s Pharma in
connection with the agreement. Lee’s Pharma has committed to spend a
minimum amount on development in the first four years of the agreement. The
agreement expires upon the expiration of the last patent covering any of the
licensed products, or twelve years from the date of the first commercial sale in
China, whichever occurs later.
F-14
6. STOCK-BASED
COMPENSATION
The
Company’s stock-based compensation plans are summarized below:
2000 Stock Option
Plan. The Company's stock option plan established in August
2000 (the “2000 Plan”) provides for grants of options to purchase up to 73,873
shares of common stock. Grants may be in the form of incentive stock options or
nonqualified options. The board of directors determines exercise prices and
vesting periods on the date of grant. Options generally vest annually over three
years and expire on the tenth anniversary of the grant date. No options were
granted or exercised under the 2000 Plan during 2007 or 2008. During
2008, options to purchase 17,826 shares of common stock were
canceled.
2006 Stock Incentive
Plan. On May 1, 2006, the Company’s board of directors
adopted, and on July 21, 2006 the Company’s stockholders approved, the 2006
Stock Incentive Plan (the “2006 Plan”). A total of 5,000,000 shares
of common stock are reserved for issuance under the 2006 Plan for grants of
incentive or nonqualified stock options, rights to purchase restricted and
unrestricted shares of common stock, stock appreciation rights and performance
share grants. A committee of the board of directors determines
exercise prices, vesting periods and any performance requirements on the date of
grant, subject to the provisions of the 2006 Plan. Options are granted at or
above the fair market value of the common stock at the grant date and expire on
the tenth anniversary of the grant date. Vesting periods are generally two to
three years. In the years ended December 31, 2008 and 2007, stock
options for the purchase of 2,560,000 and 1,380,000 shares of common stock,
respectively, were granted under the 2006 Plan. During 2008, options
to purchase 10,000 shares of common stock were canceled. There have been no
exercises under the 2006 Plan. As of December 31, 2008, 230,000
remain available for grant under the 2006 Plan. Options granted pursuant to the
2006 Stock Incentive Plan generally will become fully vested upon a termination
event occurring within one year following a change in control, as
defined. A termination event is defined as either termination of
employment or services other than for cause or constructive termination of
employees or consultants resulting from a significant reduction in either the
nature or scope of duties and responsibilities, a reduction in compensation or a
required relocation.
Other Stock Option
Activity. During 2005 and
2004, the Company issued a total of 2,653,778 stock options to employees,
directors and consultants outside of any formalized plan. These options are
exercisable within a ten-year period from the date of grant, and vest at various
intervals with all options being fully vested within two to three
years of the grant date. The options are not transferable except by will or
domestic relations order. The option price per share is not less than the fair
market value of the shares on the date of the grant. During the years
ended December 31, 2008 and 2007, options to purchase 100,000 and 25,000 shares,
respectively, were exercised.
Accounting
for Stock-Based Compensation
The
Company accounts for employee stock-based compensation in accordance with SFAS
123R. SFAS 123R requires all share-based payments to employees, including grants
of employee stock options, to be recognized in the financial statements based on
their fair values. The Company accounts for non-employee stock-based
compensation in accordance with Emerging Issues Task Force (EITF) No. 96-18,
Accounting for Equity
Instruments That Are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services. EITF 96-18
requires that companies recognize compensation expense based on the estimated
fair value of options granted to non-employees over their vesting period, which
is generally the period during which services are rendered by such
non-employees.
The
following table summarizes amounts charged to expense for stock-based
compensation related to employee and director stock option grants and
stock-based compensation recorded in connection with stock options and
restricted stock awards granted to non-employee consultants:
|
Year Ended
December 31,
|
||||||||
|
2008
|
2007
|
|||||||
|
Employee
and director stock option grants:
|
||||||||
|
Research
and development
|
$ | 159,519 | $ | 163,558 | ||||
|
General
and administrative
|
235,675 | 179,675 | ||||||
| 395,194 | 343,233 | |||||||
|
Non-employee
consultants stock option grants and restricted stock
awards:
|
||||||||
|
Research
and development
|
24,131 | 17,233 | ||||||
|
General
and administrative
|
34,002 | 142,824 | ||||||
| 58,133 | 160,057 | |||||||
|
Total
stock-based compensation
|
$ | 453,327 | $ | 503,290 | ||||
F-15
On May
13, 2008, the Company entered into a separation agreement with M. Taylor Burtis,
a former officer of the Company, that provided, among other terms that all
166,667 unvested options held by Ms. Burtis as of May 13, 2008 were immediately
vested and that she will have until December 31, 2009 to exercise the total
350,000 options held by her, at which time any unexercised options will expire.
The 2008 stock-based compensation for research and development employees
included in the table above includes incremental stock-based compensation
expense of $23,700 that was recorded in connection with the modification of the
option terms.
Determining
Fair Value
Valuation and amortization
method. The fair value of each stock award is estimated on the grant date
using the Black-Scholes option-pricing model. The estimated fair
value of employee stock options is amortized to expense using the straight-line
method over the vesting period.
Volatility. Volatility is
determined based on the Company’s estimate of fluctuation in its common stock
price and its review of comparable public company data due to the limited amount
of time that the Company’s common stock has been publicly traded.
Risk-free interest rate. The
risk-free interest rate is based on the U.S. Treasury yield curve in effect at
the time of grant commensurate with the expected term assumption.
Expected term. The expected
term of stock options granted is based on the Company’s estimate of when options
will be exercised in the future as there have been limited stock option
exercises to date. The expected term is generally applied to one group as a
whole as the Company does not expect substantially different exercise or
post-vesting termination behavior within its employee population.
Forfeitures. As
required by SFAS 123R, the Company records stock-based compensation expense only
for those awards that are expected to vest. SFAS 123R requires forfeitures to be
estimated at the time of grant and revised, if necessary, in subsequent periods
if actual forfeitures differ from those estimates. The term “forfeitures” is
distinct from “cancellations” or “expirations” and represents only the unvested
portion of the surrendered option. The Company has applied an annual forfeiture
rate of 0% to all unvested options as of December 31, 2008 as the Company has
experienced very few forfeitures to date and believes that there is insufficient
history to develop an accurate estimate of future forfeitures. This analysis
will be re-evaluated semi-annually and the forfeiture rate will be adjusted as
necessary. Ultimately, the actual expense recognized over the vesting
period will be for only those shares that vest.
The
following table summarizes weighted average values and assumptions used for
options granted to employees, directors and consultants in the periods
indicated:
|
Year Ended
December 31,
|
||||||||
|
2008
|
2007
|
|||||||
|
Volatility
|
80 | % | 80 | % | ||||
|
Weighted-average
volatility
|
80 | % | 80 | % | ||||
|
Risk-free
interest rate
|
1.50%-3.28 | % | 3.57%-4.66 | % | ||||
|
Expected
life (years)
|
5 | 5 | ||||||
|
Dividend
|
0 | 0 | ||||||
|
Weighted-average
exercise price
|
$ | 0.46 | $ | 0.57 | ||||
|
Weighted-average
grant-date fair value
|
$ | 0.30 | $ | 0.38 | ||||
Stock
Option Activity
A summary
of stock option activity under the 2000 Plan, the 2006 Plan and outside of any
formalized plan is as follows:
|
Options
Outstanding
|
Weighted
Average
Exercise Price
|
Weighted
Average
Remaining
Contracted
Term in
Years
|
Aggregate
Intrinsic
Value
|
|||||||||||||
|
Outstanding at
January 1, 2007
|
3,492,651 | $ | 0.70 | 8.4 | $ | 1,773,777 | ||||||||||
|
Options
granted
|
1,380,000 | $ | 0.57 | |||||||||||||
|
Options
exercised
|
(25,000 | ) | $ | 0.01 | ||||||||||||
|
Outstanding
at December 31, 2007
|
4,847,651 | $ | 0.67 | 8.1 | $ | 1,308,961 | ||||||||||
|
Options
granted
|
2,560,000 | $ | 0.46 | |||||||||||||
|
Options
exercised
|
(100,000 | ) | $ | 0.01 | ||||||||||||
|
Options
canceled
|
(27,826 | ) | $ | 2.23 | ||||||||||||
|
Outstanding
at December 31, 2008
|
7,279,825 | $ | 0.60 | 7.9 | $ | 989,718 | ||||||||||
|
Exercisable
at December 31, 2008
|
4,193,147 | $ | 0.68 | 6.6 | $ | 894,331 | ||||||||||
F-16
The
aggregate intrinsic value of options outstanding is calculated based on the
positive difference between the closing market price of the Company’s common
stock at the end of the respective period and the exercise price of the
underlying options. During the year ended December 31, 2008 and 2007, the
total intrinsic value of options exercised was $74,000 and $18,750, respectively
and the total amount of cash received from exercise of these options was $1,000
and $250, respectively.
As of
December 31, 2008 there was approximately $886,000 of total unrecognized
compensation cost related to unvested share-based compensation arrangements. Of
this total amount, 53%, 31% and 16% is expected to be recognized during 2009,
2010 and 2011, respectively. The Company expects 3,086,678 in
unvested options to vest in the future. The weighted average grant-date fair
value of vested and unvested options outstanding at December 31, 2008 was $0.41
and $0.31, respectively. The weighted average grant-date fair
value of vested and unvested options outstanding at December 31, 2007 was $0.39
and $0.41, respectively. The fair value of options that vested during
the years ended December 31, 2008 and 2007 was approximately $500,000 and
$701,000, respectively.
7.
INCOME TAXES
The
Company’s deferred tax assets consisted of the following at December
31:
|
2008
|
2007
|
|||||||
|
Net
operating loss carryforwards
|
$ | 7,128,000 | $ | 4,547,000 | ||||
|
Research
and development
expenses
|
13,681,000 | 9,718,000 | ||||||
|
Tax
credits
|
1,311,000 | 941,000 | ||||||
|
Capital
loss carryforward
|
340,000 | 403,000 | ||||||
|
Stock-based
compensation
|
449,000 | 375,000 | ||||||
|
Gross
deferred tax asset
|
22,909,000 | 15,984,000 | ||||||
|
Valuation
allowance
|
(22,909,000 | ) | (15,984,000 | ) | ||||
|
Net
deferred tax asset
|
$ | — | $ | — | ||||
As of
December 31, 2008, the Company had federal and state net operating loss
carryforwards of approximately $19,018,000 and $12,367,000 respectively, which
expire through 2028. In addition, the Company has federal and state
research and development and investment tax credits of approximately $1,077,000
and $356,000, respectively which expire through 2028. The amount of
net operating loss carryforwards which may be utilized annually in future
periods may be limited pursuant to Section 382 of the Internal Revenue Code as a
result of substantial changes in the Company’s ownership that have occurred or
that may occur in the future.
The
capital loss carryforward relates to the loss recorded in prior years for
Novelos’ investment in an unrelated company.
Because
of the Company’s limited operating history, continuing losses and uncertainty
associated with the utilization of the net operating loss carryforwards in the
future, management has provided a 100% allowance against the Company’s gross
deferred tax asset. In both 2008 and 2007, the increase in the
valuation allowance represents the principal difference between the Company’s
total statutory tax rate of approximately 40% and its effective rate of
0%.
In June
2006, the Financial Accounting Standards Board (“FASB”) issued FASB
Interpretation No. 48, Accounting for Uncertainty in Income
Taxes-an Interpretation of FASB Statement No. 109 (FIN No. 48), which
clarifies the accounting for uncertainty in income tax positions. This
interpretation requires that the Company recognize in its financial statements
the impact of a tax position if that position is more likely than not of being
sustained on audit, based on the technical merits of the position. The
provisions of FIN No. 48 are effective for financial statements for fiscal years
beginning after December 15, 2006. The cumulative effect of applying the
provisions of FIN No. 48, if any, are required to be recorded as an adjustment
to accumulated deficit. The Company adopted FIN No. 48 effective January 1,
2007. Upon adoption, there was no adjustment to accumulated deficit as the
Company had no unrecognized tax benefits, and there were no accrued interest
amounts or penalties related to tax contingencies.
The
Company did not have any unrecognized tax benefits or accrued interest and
penalties at any time during the years ended December 31, 2008 and 2007, and
does not anticipate having any unrecognized tax benefits over the next twelve
months. The Company is subject to audit by the IRS for tax periods
commencing January 1, 2005.
8.
NET LOSS PER SHARE
Basic net
loss per share is computed by dividing net loss attributable to common
stockholders by the weighted average number of shares of common stock
outstanding during the period. Diluted net loss per share is computed by
dividing net loss attributable to common stockholders by the weighted average
number of shares of common stock and the dilutive potential common stock
equivalents then outstanding. Potential common stock equivalents consist of
stock options, warrants and convertible preferred stock. Since the
Company has a net loss for all periods presented, the inclusion of stock options
and warrants in the computation would be antidilutive. Accordingly, basic and
diluted net loss per share are the same.
F-17
The
following potentially dilutive securities have been excluded from the
computation of diluted net loss per share since their inclusion would be
antidilutive:
|
Year Ended
December 31,
|
||||||||
|
2008
|
2007
|
|||||||
|
Stock
options
|
7,279,825 | 4,847,651 | ||||||
|
Warrants
|
28,102,033 | 26,873,047 | ||||||
|
Conversion
of preferred stock
|
36,829,192 | 18,264,000 | ||||||
9. COMMITMENTS
On May
25, 2007, the Company entered into a twenty-six-month lease for office space,
commencing July 1, 2007. Monthly rent is $7,175 per month for the
first two months and $7,675 per month for the remaining 24
months. Rent expense was $92,100 and $81,450 for the years ended
December 31, 2008 and 2007, respectively. Future minimum lease
payments under this non-cancelable lease are $61,400 in 2009.
The
Company is obligated to a Russian company, ZAO BAM, under a royalty and
technology transfer agreement. Mark Balazovsky, a director of the Company until
November 2006, is the majority shareholder of ZAO BAM. Pursuant to the royalty
and technology transfer agreement between the Company and ZAO BAM, the Company
is required to make royalty payments of 1.2% of net sales of oxidized
glutathione-based products. The Company is also required to pay ZAO BAM $2
million for each new oxidized glutathione-based drug within eighteen months
following FDA approval of such drug.
If a
royalty is not being paid to ZAO BAM on net sales of oxidized glutathione
products, then the Company is required to pay ZAO BAM 3% of all license
revenues. If license revenues exceed the Company’s cumulative
expenditures including, but not limited to, preclinical and clinical studies,
testing, FDA and other regulatory agency submission and approval costs, general
and administrative costs, and patent expenses, then the Company would be
required to pay ZAO BAM an additional 9% of the amount by which license revenues
exceed the Company’s cumulative expenditures. During 2008,
the Company paid ZAO BAM $15,000, which was 3% of license payments received
under the collaboration agreement described in Note 5. This amount is included
in research and development expense on the statement of operations.
As a
result of the assignment to Novelos of the exclusive worldwide intellectual
property and marketing rights of oxidized glutathione (excluding Russia and the
other states of the former Soviet Union), Novelos is obligated to the Oxford
Group, Ltd. for future royalties. Simyon Palmin, a founder of
Novelos, a director until August 12, 2008 and the father of the Company’s
president and chief executive officer, is president of Oxford Group,
Ltd. Mr. Palmin was also an employee of the Company and is now a
consultant to the Company. Pursuant to the agreement, as revised May
26, 2005, Novelos is required to pay Oxford Group, Ltd. a royalty in the amount
of 0.8% of the Company’s net sales of oxidized glutathione-based
products.
On July
15, 2005, the Company entered into an employment agreement with Christopher J.
Pazoles, whereby he agreed to serve as the Company’s vice president of research
and development for an initial term of two years. The agreement is automatically
renewed for successive one-year terms unless notice of termination is provided
by either party at least 60 days prior to the end of any such term. The
agreement was renewed for an additional one-year term on July 15, 2008 in
accordance with its terms. The agreement provides for a minimum salary of
$195,000 during the current and any future terms as well as participation in
standard benefit programs. The agreement further provides that upon resignation
for good reason or termination without cause, both as defined, Dr. Pazoles will
receive his base salary for the remainder of the contract term. In addition, his
benefits will be paid for the twelve months following termination.
The
Company entered into an employment agreement with Harry Palmin effective January
1, 2006, whereby he agreed to serve as the Company’s president and chief
executive officer for an initial term of two years. The agreement is
automatically renewed for successive one-year terms unless notice of termination
is provided by either party at least 90 days prior to the end of such term. The
agreement was renewed for an additional one-year term on January 1, 2009 in
accordance with its terms. The agreement provides for an initial salary of
$225,000, participation in standard benefit programs and an annual cash bonus at
the discretion of the compensation committee. The agreement further provides
that upon resignation for good reason or termination without cause, both as
defined, Mr. Palmin will receive his pro rata share of the average of his
annual bonus paid during the two fiscal years preceding his termination; his
base salary and benefits for 11 months after the date of termination and fifty
percent of his unvested stock options will vest. The agreement also contains a
non-compete provision, which prohibits Mr. Palmin from competing with the
Company for one year after termination of his employment with the
Company.
F-18
10. SUBSEQUENT
EVENTS
2009
Collaboration Agreement
On
February 11, 2009 Novelos entered into a collaboration agreement
(the “Collaboration Agreement”) with Mundipharma International
Corporation Limited (“Mundipharma”) to develop manufacture and commercialize
Licensed Products (as defined in the Collaboration Agreement), which includes
the Company’s lead compound, NOV-002, in Europe and Asia/Pacific (excluding
China) (the “Territory”). Mundipharma is an independent associated
company of Purdue Pharma. L.P. (“Purdue”).
Under the
Collaboration Agreement, Mundipharma received an exclusive license to develop,
manufacture, market, sell or otherwise distribute the Licensed Products and
improvements thereon in the Territory. Mundipharma will pay Novelos $2.5 million
upon the launch of NOV-002 in each country, up to a maximum of $25 million. In
addition, Mundipharma will make fixed sales-based payments up to an aggregate of
$60 million upon the achievement of certain annual sales levels payable once the
annual net sales exceed the specified thresholds.
Mundipharma
will also pay as royalties to Novelos, during the term of the Collaboration
Agreement, a double-digit percentage on net sales of Licensed Products in
countries within the Territory where, as of the effective date thereof, Novelos
holds patents on the licensed technology based upon a four-tier royalty
schedule. Royalties in countries in the Territory where Novelos does
not hold patents as of the effective date will be paid at 50% of the royalty
rates in countries where patents are held. The royalties will be calculated
based on the incremental net sales in the respective royalty tiers and shall be
due on net sales in each country in the Territory where patents are held until
the last patent expires in the respective country. In countries in
the Territory where Novelos does not hold patents as of the effective date of
the Collaboration Agreement, royalties will be due until the earlier of 15 years
from the date of Agreement or the introduction of a generic in the respective
country resulting in a 20% drop in Mundipharma’s market share in such
country.
The
launch of Licensed Products, including initiation of regulatory and pricing
approvals, and subsequent commercial efforts to market and sell Licensed
Products in each country in the Territory will be determined by Mundipharma
based on its assessment of the commercial viability of the Licensed Products,
the regulatory environment and other factors. Novelos has no assurance that it
will receive any amount of launch payments, fixed sales-based payments or
royalties.
Under the
Collaboration Agreement, Novelos is responsible for the cost and execution of
development, regulatory submissions and commercialization of NOV-002 outside the
Territory and Mundipharma is responsible for the cost and execution of certain
development activities, all regulatory submissions and all commercialization
within the Territory. In the unlikely event that Mundipharma is
required to conduct an additional Phase 3 clinical trial in first-line advanced
stage non-small cell lung cancer in order to gain regulatory approval in Europe,
Mundipharma will be entitled to recover the full cost of such trial by reducing
milestone, fixed sales-based payments and royalty payments to Novelos by up to
50% of the payments owed until Mundipharma recovers the full costs of such
trial. In order for Mundipharma or Novelos to access the other
party’s data or intellectual property related to Independent Trials (as defined
in the Collaboration Agreement), the accessing party must pay the sponsoring
party 50% of the cost of such trial.
For
countries in which patents are held, the Collaboration Agreement expires on a
country-by-country basis within the Territory on the earlier of (1) expiration
of the last applicable Novelos patent within the country or (2) the
determination that any patents within the country are invalid, obvious or
otherwise unenforceable. For countries in which no patents are held,
the Agreement expires 15 years from effective date or upon generic product
competition in the country that results in a 20% drop in Mundipharma’s market
share. Novelos may terminate the Collaboration Agreement upon breach or default
by Mundipharma. Mundipharma may terminate the Collaboration Agreement
upon breach or default, filing of voluntary or involuntary bankruptcy by
Novelos, the termination of certain agreements with companies associated with
the originators of the licensed technology, or 30-day notice for no
reason. If any regulatory approval within the Territory is suspended
as a result of issues related to the safety of the Licensed Products, then
Mundipharma’s obligations under the Collaboration Agreement will be suspended
until the regulatory approval is reinstated. If that reinstatement
does not occur within twelve months of the suspension, then Mundipharma may
terminate the Collaboration Agreement.
Issuance
of Series E Preferred Stock
Sale
of Series E Preferred Stock to Purdue Pharma
Concurrently
with the execution of the Collaboration Agreement, Novelos sold to Purdue, an
independent associated company of Mundipharma, 200 shares of a newly created
series of the Company’s preferred stock, designated “Series E Convertible
Preferred Stock”, par value $0.00001 per share (the “Series E Preferred Stock”)
and a warrant (the “Series E Warrant”) to purchase 9,230,769 shares of Novelos
common stock for an aggregate purchase price of $10,000,000 (the “Series E
Financing”). Pursuant to the related securities purchase agreement
with Purdue (the “Purchase Agreement”), Purdue has the right to designate one
observer to attend all meetings of the Company’s 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 Purdue no longer holds at least one-half of
the Series E Preferred Stock issued to them at closing. Purdue has the right to
participate in future equity financings with proceeds to the Company of at least
$20 million.
F-19
The
Series E Warrant is initially exercisable for an aggregate of 9,230,769 shares
of Novelos common stock at an exercise price of $0.65 per share. The warrant
expires on December 31, 2015. The warrant exercise price and/or the
common stock issuable pursuant to such warrant will be subject to adjustment for
stock dividends, stock splits or similar capital reorganizations so that the
rights of the warrant holders after such event will be equivalent to the rights
of warrant holders prior to such event.
Exchange
of Series D Preferred Stock for Series E Preferred Stock
The
Company also entered into an exchange agreement with the holders of Series D
Preferred Stock under which all 413.5 outstanding shares of Series D
Preferred Stock and accumulated but unpaid dividends thereon were exchanged for
445.442875 shares of Series E Preferred Stock. The rights and
preferences of the Series E Preferred Stock are substantially the same as the
Series D Preferred Stock. In addition, the holders of Series D Preferred Stock
waived liquidated damages through the date of the exchange as a result of the
Company’s failure to file a registration statement covering the shares of common
stock underlying the Series D Preferred Stock and warrants not otherwise
registered. In connection with the execution of this exchange
agreement, the Series B Warrants and the Series D Warrants were amended to
extend the expiration of the warrants to December 31, 2015 and to remove the
forced exercise provision. Also, the registration rights agreement dated May 2,
2007 with the holders of Series D Preferred Stock was amended to revise the
definition of registrable securities under the agreement to refer to Series E
Preferred Stock.
Terms
of Series E Preferred Stock
The
shares of Series E Preferred Stock have a stated value of $50,000 per share and
are convertible into shares of common stock any time after issuance at the
option of the holder at $0.65 per share of common stock for an aggregate of
49,649,446 shares of common stock. If there is an effective
registration statement covering the shares of common stock underlying the Series
E Preferred Stock and the VWAP, as defined in the Series E Certificate of
Designations, of Novelos common stock exceeds $2.00 for 20 consecutive trading
days, then the outstanding Series E Preferred Stock will automatically convert
into common stock at the conversion price then in effect. The
conversion price will be subject to adjustment for stock dividends, stock splits
or similar capital reorganizations.
The
Series E Preferred Stock has an annual dividend rate of 9%, payable
semi-annually on June 30 and December 31. Such dividends may be paid
in cash, in shares of Series E Preferred Stock or in registered shares of
Novelos common stock at the Company’s option, subject to certain
conditions.
For as
long as any shares of Series E Preferred Stock remain outstanding, Novelos will
be prohibited from (i) paying dividends to its common stockholders, (ii)
amending its 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 E Preferred Stock (except
for certain exempted issuances), (iv) increasing the number of shares of Series
E Preferred Stock or issuing any additional shares of Series E Preferred Stock,
(v) selling or otherwise disposing of all or substantially all of its assets (or
in the case of licensing, any material intellectual property) or entering into a
merger or consolidation with another company unless Novelos is the surviving
corporation, the Series E Preferred Stock remains outstanding and there are no
changes to the rights and preferences of the Series E Preferred Stock, (vi)
redeeming or repurchasing any capital stock other than the Series E 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.
Registration
Rights Agreement
Simultaneous
with the execution of the Purchase Agreement, the Company entered into a
registration rights agreement (the “Registration Rights Agreement”) with Purdue
and the holders (the “Series D Investors) of Novelos Series D Preferred
Stock. The Registration Rights Agreement requires Novelos to file
with the Securities and Exchange Commission no later than 5 business days
following the six-month anniversary of the execution of the Securities Purchase
Agreement, a registration statement covering the resale of (i) a number of
shares of common stock equal to 100% of the shares issuable upon conversion of
the Series E Preferred Stock (excluding 12,000,000 shares of common stock
issuable upon conversion of the Series E Preferred Stock issued in exchange for
shares of outstanding Series D Preferred Stock as described below that were
included on a prior registration statement), (ii) 9,230,769 shares of common
stock issuable upon exercise of the warrants issued to Purdue and (iii)
11,865,381 shares of common stock issuable upon exercise of warrants held by the
Series D Investors. Novelos will be required to use its best efforts to have the
registration statement declared effective and to keep the registration statement
continuously effective under the Securities Act until the earlier of the date
when all the registrable securities covered by the registration statement have
been sold or the second anniversary of the closing. In the event
Novelos fails to file the registration statement within the timeframe specified
by the Registration Rights Agreement, it will be required to pay to Purdue and
the Series D Investors liquidated damages equal to 1.5% per month (pro-rated on
a daily basis for any period of less than a full month) of the aggregate
purchase price of the Series E Preferred Stock and warrants until the delinquent
registration statement is filed. Novelos will be allowed to suspend
the use of the registration statement for not more than 15 consecutive days or
for a total of not more than 30 days in any 12 month period. The
Registration Rights Agreement replaces a prior agreement dated April 11, 2008
between Novelos and the Series D Investors.
F-20
Advisor
Fees
Ferghana
Partners, Inc. (“Ferghana”), a New York consulting firm, received a cash fee for
their services in connection with the negotiation and execution of the
Collaboration Agreement equal to $700,000 (or seven percent (7%) of the gross
proceeds to the Company resulting from the sale of Series E Preferred Stock and
Common Stock Purchase Warrants to Purdue in connection with the Collaboration
Agreement). Ferghana will also receive cash fees equal to six percent
(6%) of all payments to Novelos by Mundipharma under the Collaboration Agreement
other than royalties on net sales.
Accounting
Treatment
The
Company is currently evaluating the accounting treatment for the Series E
Financing and Collaboration Agreement. It is anticipated that the
Series E Preferred Stock will be classified outside of permanent
equity.
F-21