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As
filed with the Securities and Exchange Commission on July 28, 2006
Registration Statement No. 333-
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
IDERA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction of incorporation or organization)
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04-3072298
(I.R.S. Employer Identification No.) |
345 Vassar Street
Cambridge, Massachusetts 02139
(617) 679-5500
(Address, including zip code, and telephone number, including area code, of registrants principal executive offices)
Sudhir Agrawal, D. Phil.
Chief Executive Officer
Idera Pharmaceuticals, Inc.
345 Vassar Street
Cambridge, Massachusetts 02139
(617) 679-5500
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies to:
David E. Redlick, Esq.
Stuart M. Falber, Esq.
Wilmer Cutler Pickering Hale and Dorr LLP
60 State Street
Boston, Massachusetts 02109
Telephone: (617) 526-6000
Telecopy: (617) 526-5000
Approximate date of commencement of proposed sale to public: As soon as practicable after
this Registration Statement becomes effective.
If the only securities being registered on this Form are being offered pursuant to dividend or
interest reinvestment plans, please check the following box. o
If any of the securities being registered on this Form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities
offered only in connection with dividend or interest reinvestment plans, check the following box. þ
If this Form is filed to register additional securities for an offering pursuant to Rule
462(b) under the Securities Act, please check the following box and list the Securities Act
registration statement number of the earlier effective registration statement for the same
offering.
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If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities
Act, check the following box and list the Securities Act registration statement number of the
earlier effective registration statement for the same offering. o ______.
If this Form is a registration statement pursuant to General Instruction I.D. or a
post-effective amendment thereto that shall become effective upon filing with the Commission
pursuant to Rule 462(e) under the Securities Act, check the following box. o
If this Form is a post-effective amendment to a registration statement filed pursuant to
General Instruction I.D. filed to register additional securities or additional classes of
securities pursuant to Rule 413(b) under the Securities Act, check the following box. o
CALCULATION OF REGISTRATION FEE
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Proposed |
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Proposed |
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Amount |
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Maximum |
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Maximum |
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to be |
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Offering Price |
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Aggregate |
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Amount of |
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Title of Shares to be Registered |
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Registered(1) |
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Per Share (2) |
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Offering Price |
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Registration Fee |
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Common Stock, $0.001 par value per share
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683,593 |
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2.88 |
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1,968,748 |
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$ |
211 |
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(1) |
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Consists of (a) 683,593 shares of common stock and (b) additional shares, of a currently
indeterminable amount, as may from time to time become issuable by reason of stock splits,
stock dividends and other similar transactions, which shares are registered hereunder pursuant
to Rule 416 under the Securities Act. |
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(2) |
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Estimated solely for purposes of calculating the registration fee pursuant to Rule 457(c)
under the Securities Act and based upon the average of the high and low prices on the American
Stock Exchange on July 25, 2006. |
The Company hereby amends this Registration Statement on such date or dates as may be necessary to
delay its effective date until the Company shall file a further amendment which specifically states
that this Registration Statement shall thereafter become effective in accordance with Section 8(a)
of the Securities Act of 1933 or until the Registration Statement shall become effective on such
date as the Commission, acting pursuant to said Section 8(a), shall determine.
The information in this prospectus is not complete and may be changed. The selling
stockholder named in this prospectus may not sell these securities until the registration statement
filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to
sell these securities and the selling stockholder named in this prospectus is not soliciting offers
to buy these securities in any jurisdiction where the offer or sale is not permitted.
Subject
to completion, dated July 28, 2006
PROSPECTUS
IDERA PHARMACEUTICALS, INC.
683,593 SHARES OF COMMON STOCK
This prospectus relates to the resale from time to time of up to 683,593 shares of common stock of
Idera Pharmaceuticals, Inc. by the selling stockholder identified in this prospectus. We will not
receive any proceeds from the sale of the shares offered by this prospectus.
The selling stockholder identified in this prospectus, or its pledgees, donees, transferees or
other successors-in-interest, may offer the shares from time to time through public or private
transactions at prevailing market prices, at prices related to prevailing market prices or at
privately negotiated prices.
Our common
stock is traded on the American Stock Exchange under the symbol
IDP. On July 27,
2006, the closing sale price of our common stock on the American
Stock Exchange was $2.85 per
share. You are urged to obtain current market quotations for the common stock.
Investing in our common stock involves a high degree of risk. See Risk Factors beginning on
page 2.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is [_____] [__], 2006.
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TABLE OF CONTENTS
We have not authorized anyone to provide you with information different from that contained or
incorporated by reference in this prospectus. The selling stockholder is offering to sell, and
seeking offers to buy, shares of our common stock only in jurisdictions where offers and sales are
permitted. The information contained in this prospectus is accurate only as of the date of this
prospectus, regardless of the time of delivery of this prospectus or of any sale of common
stock.
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PROSPECTUS SUMMARY
This summary highlights important features of this offering and the information included or
incorporated by reference in this prospectus. This summary may not contain all of the information
that is important to you. You should read the entire prospectus carefully, including Risk Factors
beginning on page 2, before deciding to invest in our common stock.
Idera Pharmaceuticals, Inc.
We are engaged in the discovery and development of novel therapeutics that modulate immune
responses through Toll-like Receptors, or TLRs, for the treatment of multiple diseases. We have
developed proprietary DNA- and RNA-based compounds that modulate TLRs and are targeted to TLR7,
TLR8 or TLR9. We believe that these immune modulatory oligonucleotides, or IMO
compounds, are broadly applicable to large and growing markets where significant unmet medical
needs exist, including oncology, asthma and allergies, infectious diseases and autoimmune diseases.
IMO-2055, our lead drug candidate, is a synthetic DNA-based compound, which acts as an agonist for
TLR9 and triggers the activation and modulation of the immune system. IMO-2055 is currently in a
Phase 2 clinical trial as a monotherapy for renal cell carcinoma and a Phase 1/2 clinical trial in
combination with chemotherapy agents for solid tumors. We have selected another TLR9 agonist,
IMO-2125, as a lead compound for infectious diseases. We are also collaborating with Novartis
International Pharmaceuticals, Ltd., or Novartis, to develop treatments for asthma and allergies
using other of our TLR9 agonist compounds. Our IMO compounds targeted to TLR7 and TLR8 are in the
discovery stage.
Corporate Information
Our executive offices are located at 345 Vassar Street, Cambridge, MA 02139, our telephone
number is (617) 679-5500 and our Internet address is www.iderapharma.com. The information on our
Internet website is not incorporated by reference in this prospectus and should not be considered
to be part of this prospectus. Our website address is included in this prospectus as an inactive
technical reference only. Unless the context otherwise requires, references in this prospectus to
Idera Pharmaceuticals, we, us, and our refer to Idera Pharmaceuticals, Inc.
Ideratm , Amplivaxtm ,
IMOtm and Targeted Immune Therapy are our trademarks.
IMOxine® and GEM® are our registered trademarks. All
other trademarks and service marks appearing in this registration statement are the property of
their respective owners.
The Offering
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Common Stock offered by selling stockholder
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683,593 shares |
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Use of proceeds
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We will not receive any
proceeds from the sale of
shares in this offering |
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American Stock Exchange symbol
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IDP |
RISK FACTORS
Investing in our common stock involves a high degree of risk. You should carefully consider the
risks and uncertainties described below in addition to the other information included or
incorporated by reference in this prospectus before purchasing our common stock. If any of the
following risks actually occurs, our business, financial condition or results of operations would
likely suffer, possibly materially. In that case, the trading price of our common stock could
fall, and you may lose all or part of the money you paid to buy our common stock.
Risks Relating to Our Financial Results and Need for Financing
We have incurred substantial losses and expect to continue to incur losses. We will not be
successful unless we reverse this trend.
We have incurred losses in every year since our inception, except for 2002 when our
recognition of revenues under a license and collaboration agreement resulted in us reporting net
income for that year. As of March 31, 2006, we had incurred operating losses of approximately
$316.7 million. We expect to continue to incur substantial operating losses in future periods.
These losses, among other things, have had and will continue to have an adverse effect on our
stockholders equity, total assets and working capital.
We have received no revenues from the sale of drugs. To date, almost all of our revenues have
been from collaborative and license agreements. We have devoted substantially all of our efforts
to research and development, including clinical trials, and we have not completed development of
any drugs. Because of the numerous risks and uncertainties associated with developing drugs, we
are unable to predict the extent of any future losses, whether or when any of our products will
become commercially available, or when we will become profitable, if at all.
We will need additional financing, which may be difficult to obtain. Our failure to obtain
necessary financing or doing so on unattractive terms could adversely affect our discovery and
development programs and other operations.
We will require substantial funds to conduct research and development, including preclinical
testing and clinical trials of our drugs. We will also require substantial funds to conduct
regulatory activities and to establish commercial manufacturing, marketing and sales capabilities.
We believe that, based on our current operating plan, our existing cash, cash equivalents and
short-term investments, together with the $3.5 million that we raised in July 2006 through the sale
of common stock to the selling stockholder under the March 2006 Common Stock Purchase Agreement
with the selling stockholder, will be sufficient to fund our operations through March 2007. Under
the Common Stock Purchase Agreement, we secured a commitment from the selling stockholder to
purchase from us up to a total of $9.75 million of our common stock during the period from June 24,
2006 through December 31, 2006 in up to three drawdowns made by us, at our discretion. In July
2006, we accessed $3.5 million of this commitment. Our ability to access the remaining $6.25
million of this commitment and sell common stock to such investor is subject to the effectiveness
of a registration statement covering the resale of such common stock. If we draw down this $6.25
million, we expect to have sufficient cash and investments to be able to pursue our clinical and
preclinical development programs and continue operations through August 2007.
We will need to raise additional funds to operate our business beyond such time. We believe
that the key factors that will affect our ability to obtain additional funding are:
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the success of our clinical and preclinical development programs; |
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the receptivity of the capital markets to financings by biotechnology companies; and |
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our ability to enter into strategic collaborations with biotechnology and
pharmaceutical companies and the success of such collaborations. |
Additional financing may not be available to us when we need it or may not be available to us
on favorable terms. We could be required to seek funds through arrangements with collaborators or
others that may require us to relinquish rights to some of our technologies, drug candidates or
drugs which we would otherwise pursue on our
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own. In addition, if we raise additional funds by issuing equity securities, our then existing
stockholders will experience dilution. The terms of any financing may adversely affect the holdings
or the rights of existing stockholders. If we are unable to obtain adequate funding on a timely
basis or at all, we may be required to significantly curtail one or more of our discovery or
development programs. For example, we significantly curtailed expenditures on our research and
development programs during 1999 and 2000 because we did not have sufficient funds available to
advance these programs at planned levels.
Risks Relating to Our Business, Strategy and Industry
We are depending heavily on the success of our lead drug candidate, IMO-2055, which is in clinical
development. If we are unable to commercialize this product, or experience significant delays in
doing so, our business will be materially harmed.
We are investing a significant portion of our time and financial resources in the development
of our lead drug candidate, IMO-2055. We anticipate that our ability to generate product revenues
will depend heavily on the successful development and commercialization of this product. The
commercial success of this product will depend on several factors, including the following:
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acceptable safety profile during the trial and during commercial use; |
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successful completion of clinical trials; |
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receipt of marketing approvals from the U.S. Food and Drug Administration, or the FDA,
and equivalent foreign regulatory authorities; |
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establishing commercial manufacturing arrangements with third-party manufacturers; |
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launching commercial sales of the product, whether alone or in collaboration with others; and |
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acceptance of the product in the medical community and with third-party payors. |
Our efforts to commercialize this product are at an early stage, as we are currently
conducting a Phase 2 clinical trial in patients with metastatic or recurrent clear cell renal
carcinoma. If we are not successful in commercializing this product, or are significantly delayed
in doing so, our business will be materially harmed.
If our clinical trials are unsuccessful, or if they are significantly delayed, we may not be able
to develop and commercialize our products.
We may not be able to successfully complete any clinical trial of a potential product within
any specified time period. In some cases, we may not be able to complete the trial at all.
Moreover, clinical trials may not show our potential products to be both safe and efficacious.
Thus, the FDA and other regulatory authorities may not approve any of our potential products for
any indication.
In order to obtain regulatory approvals for the commercial sale of our products, we will be
required to complete extensive clinical trials in humans to demonstrate the safety and efficacy of
our drug candidates. We may not be able to obtain authority from the FDA or other equivalent
foreign regulatory agencies to complete these trials or commence and complete any other clinical
trials.
The results from preclinical testing of a drug candidate that is under development may not be
predictive of results that will be obtained in human clinical trials. In addition, the results of
early human clinical trials may not be predictive of results that will be obtained in larger scale,
advanced stage clinical trials. A failure of one or more of our clinical trials can occur at any
stage of testing. Further, there is to date little data on the long-term clinical safety of our
lead compounds under conditions of prolonged use in humans, or on any long-term consequences
subsequent to human use. We may experience numerous unforeseen events during, or as a result of,
preclinical testing and the clinical trial process that could delay or inhibit our ability to
receive regulatory approval or to commercialize our products, including:
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regulators or institutional review boards may not authorize us to commence a clinical
trial or conduct a clinical trial at a prospective trial site; |
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our preclinical tests or clinical trials may produce negative or inconclusive results,
and we may decide, or regulators may require us, to conduct additional preclinical testing
or clinical trials or we may abandon projects that we expect may not be promising; |
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we might have to suspend or terminate our clinical trials if the participating patients
are being exposed to unacceptable health risks; |
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regulators or institutional review boards may require that we hold, suspend or
terminate clinical research for various reasons, including noncompliance with regulatory
requirements; |
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the cost of our clinical trials may be greater than we currently anticipate; and |
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the effects of our products may not be the desired effects or may include undesirable
side effects or the products may have other unexpected characteristics. |
As an example, in 1997, after reviewing the results from the clinical trial of GEM91, a first
generation antisense compound and our lead drug candidate at the time, we determined not to
continue the development of GEM91 and suspended clinical trials of this product candidate.
The rate of completion of clinical trials is dependent in part upon the rate of enrollment of
patients. The statistical design of our ongoing Phase 2 clinical trial of IMO-2055 in renal cell
carcinoma was originally based on patients who had already failed one course of therapy, whom we
refer to as second-line patients. As of October 2005, our enrollment of second-line patients was
less than anticipated, whereas the enrollment of treatment-naïve patients was more than expected.
As a result, the trial protocol was amended in October 2005 to accommodate statistical endpoints
for both treatment-naïve and second-line patients, thus extending the completion of the trial
beyond the time we expected. Patient accrual is a function of many factors, including:
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the size of the patient population, |
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the proximity of patients to clinical sites, |
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the eligibility criteria for the study, |
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the nature of the study, |
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the existence of competitive clinical trials, and |
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the availability of alternative treatments. |
Our product development costs will increase if we experience delays in our clinical trials. We
do not know whether planned clinical trials will begin as planned, will need to be restructured or
will be completed on schedule, if at all. Significant clinical trial delays also could allow our
competitors to bring products to market before we do and impair our ability to commercialize our
products.
We face substantial competition which may result in others discovering, developing or
commercializing drugs before or more successfully than us.
The biotechnology industry is highly competitive and characterized by rapid and significant
technological change. We face, and will continue to face, intense competition from organizations
such as pharmaceutical and biotechnology companies, as well as academic and research institutions
and government agencies. Some of these organizations are pursuing products based on technologies
similar to our technologies. Other of these organizations have developed and are marketing
products, or are pursuing other technological approaches designed to produce
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products, that are competitive with our product candidates in the therapeutic effect these
competitive products have on diseases targeted by our product candidates. Our competitors may
discover, develop or commercialize products or other novel technologies that are more effective,
safer or less costly than any that we are developing. Our competitors may also obtain FDA or other
regulatory approval for their products more rapidly than we may obtain approval for ours. As
examples, the FDA recently approved Sutent® and Nexavar® for use in renal cell carcinoma, which is
the indication for which we are evaluating IMO-2055 monotherapy in our Phase 2 trial. Two of our
competitors are currently evaluating TLR9 agonists in Phase 3 clinical trials.
Many of our competitors are substantially larger than we are and have greater capital
resources, research and development staffs and facilities than we have. In addition, many of our
competitors are more experienced than we are in drug discovery, development and commercialization,
obtaining regulatory approvals and drug manufacturing and marketing.
We anticipate that the competition with our products and technologies will be based on a
number of factors including product efficacy, safety, availability and price. The timing of market
introduction of our products and competitive products will also affect competition among products.
We expect the relative speed with which we can develop products, complete the clinical trials and
approval processes and supply commercial quantities of the products to the market to be important
competitive factors. Our competitive position will also depend upon our ability to attract and
retain qualified personnel, to obtain patent protection or otherwise develop proprietary products
or processes and to secure sufficient capital resources for the period between technological
conception and commercial sales.
Because the products that we may develop will be based on new technologies and therapeutic
approaches, the market may not be receptive to these products upon their introduction.
The commercial success of any of our products for which we may obtain marketing approval from
the FDA or other regulatory authorities will depend upon their acceptance by the medical community
and third-party payors as clinically useful, cost-effective and safe. Many of the products that we
are developing are based upon technologies or therapeutic approaches that are relatively new and
unproven. The FDA has not granted marketing approval to any products based on IMO technology or
TLR9 agonists, and no such products are currently being marketed. As a result, it may be more
difficult for us to achieve regulatory approval or market acceptance of our products. In addition,
if products based upon TLR technology being developed by our
competitors have negative preclinical or clinical
trial results or otherwise are viewed negatively, such events could negatively impact the
perception of our TLR technology and market acceptance of our products. Our efforts to educate the
medical community on these potentially unique approaches may require greater resources than would
be typically required for products based on conventional technologies or therapeutic approaches.
The safety, efficacy, convenience and cost-effectiveness of our products as compared to competitive
products will also affect market acceptance.
Competition for technical and management personnel is intense in our industry, and we may not be
able to sustain our operations or grow if we are unable to attract and retain key personnel.
Our success is highly dependent on the retention of principal members of our technical and
management staff, including Sudhir Agrawal and Robert Karr. Dr. Agrawal serves as our Chief
Executive Officer and Chief Scientific Officer. Dr. Karr serves as our President. Dr. Agrawal has
made significant contributions to the field of antisense technology, and has led the development of
IMO Technology. He is named as an inventor on over 230 patents and patent applications worldwide.
Dr. Karr has extensive experience in the pharmaceutical industry. Drs. Agrawal and Karr provide us
leadership for management, research and development activities. The loss of either Dr. Agrawals or
Dr. Karrs services would be detrimental to our ongoing scientific progress and the execution of
our business plan.
We are a party to an employment agreement with Dr. Agrawal for a term ending on October 19,
2008, subject to annual renewals. This agreement may be terminated by us or Dr. Agrawal for any
reason or no reason at any time upon notice to the other party. We do not carry key man life
insurance for Dr. Agrawal.
We are a party to an employment agreement with Dr. Karr for a term ending on December 5, 2007,
subject to annual renewals. This agreement may be terminated by us or Dr. Karr for any reason or no
reason at any time upon notice to the other party. We do not carry key man life insurance for Dr.
Karr.
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Our future growth will require hiring a significant number of qualified technical and
management personnel. Recruiting and retaining such personnel in the future will be critical to our
success. There is intense competition from other companies and research and academic institutions
for qualified personnel in the areas of our activities. If we are not able to continue to attract
and retain, on acceptable terms, the qualified personnel necessary for the continued development of
our business, we may not be able to sustain our operations or grow.
Regulatory Risks
We may not be able to obtain marketing approval for products resulting from our development
efforts.
All of the products that we are developing or may develop in the future will require
additional research and development, extensive preclinical studies and clinical trials and
regulatory approval prior to any commercial sales. This process is lengthy, often taking a number
of years, is uncertain and is expensive. Since our inception, we have conducted clinical trials of
a number of compounds. In 1997, we determined not to continue clinical development of GEM91, our
lead product candidate at the time. Currently, we are conducting clinical trials of IMO-2055.
We may need to address a number of technological challenges in order to complete development
of our products. Moreover, these products may not be effective in treating any disease or may prove
to have undesirable or unintended side effects, unintended alteration of the immune system over
time, toxicities or other characteristics that may preclude our obtaining regulatory approval or
prevent or limit commercial use.
We are subject to comprehensive regulatory requirements, with which compliance is costly and
time-consuming; if we fail to comply with these requirements, we could be subject to adverse
consequences and penalties.
The testing, manufacturing, labeling, advertising, promotion, export and marketing of our
products are subject to extensive regulation by governmental authorities in Europe, the United
States and elsewhere throughout the world.
In general, submission of materials requesting permission to conduct clinical trials may not
result in authorization by the FDA or any equivalent foreign regulatory agency to commence clinical
trials. Further, permission to continue ongoing trials may be withdrawn by the FDA or other
regulatory agency at any time after initiation, based on new information available after the
initial authorization to commence clinical trials. In addition, submission of an application for
marketing approval to the relevant regulatory agency following completion of clinical trials may
not result in the regulatory agency approving the application if applicable regulatory criteria are
not satisfied, and may result in the regulatory agency requiring additional testing or information.
Any regulatory approval of a product may contain limitations on the indicated uses for which
the product may be marketed or requirements for costly post-marketing testing and surveillance to
monitor the safety or efficacy of the product. Any product for which we obtain marketing approval,
along with the facilities at which the product is manufactured, any post-approval clinical data and
any advertising and promotional activities for the product will be subject to continual review and
periodic inspections by the FDA and other regulatory agencies.
Both before and after approval is obtained, violations of regulatory requirements may result
in:
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the regulatory agencys delay in approving, or refusal to approve, an application for
approval of a product; |
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restrictions on such products or the manufacturing of such products; |
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withdrawal of the products from the market; |
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warning letters; |
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voluntary or mandatory recall; |
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fines; |
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suspension or withdrawal of regulatory approvals; |
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product seizure; |
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refusal to permit the import or export of our products; |
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injunctions or the imposition of civil penalties; and |
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criminal penalties. |
We have only limited experience in regulatory affairs and our products are based on new
technologies; these factors may affect our ability or the time we require to obtain necessary
regulatory approvals.
We have only limited experience in filing the applications necessary to gain regulatory
approvals. Moreover, the products that result from our research and development programs will
likely be based on new technologies and new therapeutic approaches that have not been extensively
tested in humans. The regulatory requirements governing these types of products may be more
rigorous than for conventional drugs. As a result, we may experience a longer regulatory process in
connection with obtaining regulatory approvals of any product that we develop.
Risks Relating to Collaborators
We need to establish collaborative relationships in order to succeed.
An important element of our business strategy includes entering into collaborative
relationships for the development and commercialization of products based on our discoveries. We
face significant competition in seeking appropriate collaborators. Moreover, these arrangements are
complex to negotiate and time-consuming to document. We may not be successful in our efforts to
establish collaborative relationships or other alternative arrangements.
The success of collaboration arrangements will depend heavily on the efforts and activities of
our collaborators. Our collaborators will have significant discretion in determining the efforts
and resources that they will apply to these collaborations. The risks that we face in connection
with these collaborations include the following:
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disputes may arise in the future with respect to the ownership of rights to technology
developed with collaborators; |
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disagreements with collaborators could delay or terminate the research, development or
commercialization of products, or result in litigation or arbitration; |
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we may have difficulty enforcing the contracts if one of our collaborators fails to
perform; |
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our collaborators may terminate their collaborations with us, which could make it
difficult for us to attract new collaborators or adversely affect the perception of us in
the business or financial communities; |
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collaborators have considerable discretion in electing whether to pursue the
development of any additional drugs and may pursue technologies or products either on their
own or in collaboration with our competitors that are similar to or competitive with our
technologies or products that are the subject of the collaboration with us; and |
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our collaborators may change the focus of their development and commercialization
efforts. Pharmaceutical and biotechnology companies historically have re-evaluated their
priorities following mergers and consolidations, which have been common in recent years in
these industries. The ability of our products to reach their potential could be limited if
our collaborators decrease or fail to increase spending relating to such products. |
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Given these risks, it is possible that any collaborative arrangements into which we enter may
not be successful. In May 2005, we entered into collaborative arrangements with Novartis involving
our IMO technology for application in asthma and allergies. Previous collaborative arrangements to
which we were a party with F. Hoffmann-La Roche and G.D. Searle & Co., involving our antisense
technology, were terminated prior to the development of any product. The failure of any of our
collaborative relationships could delay our drug development or impair commercialization of our
products.
Risks Relating to Intellectual Property
If we are unable to obtain patent protection for our discoveries, the value of our technology and
products will be adversely affected.
Our patent positions, and those of other drug discovery companies, are generally uncertain and
involve complex legal, scientific and factual questions.
Our ability to develop and commercialize drugs depends in significant part on our ability to:
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obtain patents; |
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obtain licenses to the proprietary rights of others on commercially reasonable terms; |
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operate without infringing upon the proprietary rights of others; |
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prevent others from infringing on our proprietary rights; and |
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protect trade secrets. |
We do not know whether any of our patent applications or those patent applications that we
license will result in the issuance of any patents. Our issued patents and those that may issue in
the future, or those licensed to us, may be challenged, invalidated or circumvented, and the rights
granted thereunder may not provide us proprietary protection or competitive advantages against
competitors with similar technology. Furthermore, our competitors may independently develop similar
technologies or duplicate any technology developed by us. Because of the extensive time required
for development, testing and regulatory review of a potential product, it is possible that, before
any of our products can be commercialized, any related patent may expire or remain in force for
only a short period following commercialization, thus reducing any advantage of the patent.
Because patent applications in the United States and many foreign jurisdictions are typically
not published until 18 months after filing, or in some cases not at all, and because publications
of discoveries in the scientific literature often lag behind actual discoveries, neither we nor our
licensors can be certain that we or they were the first to make the inventions claimed in issued
patents or pending patent applications, or that we or they were the first to file for protection of
the inventions set forth in these patent applications.
Third parties may own or control patents or patent applications and require us to seek licenses,
which could increase our development and commercialization costs, or prevent us from developing or
marketing products.
We may not have rights under some patents or patent applications related to our products.
Third parties may own or control these patents and patent applications in the United States and
abroad. Therefore, in some cases, to develop, manufacture, sell or import some of our products, we
or our collaborators may choose to seek, or be required to seek, licenses under third-party patents
issued in the United States and abroad or under patents that might issue from United States and
foreign patent applications. In such an event, we would be required to pay license fees or
royalties or both to the licensor. If licenses are not available to us on acceptable terms, we or
our collaborators may not be able to develop, manufacture, sell or import these products.
We may lose our rights to patents, patent applications or technologies of third parties if our
licenses from these third parties are terminated. In such an event, we might not be able to develop
or commercialize products covered by the licenses.
-8-
We are party to six license agreements in the field of antisense technology under which we
have acquired rights to patents, patent applications and technology of third parties. Under these
licenses we are obligated to pay royalties on net sales by us of products or processes covered by a
valid claim of a patent or patent application licensed to us. We also are required in some cases to
pay a specified percentage of any sublicense income that we may receive. These licenses impose
various commercialization, sublicensing, insurance and other obligations on us. Our failure to
comply with these requirements could result in termination of the licenses. These licenses
generally will otherwise remain in effect until the expiration of all valid claims of the patents
covered by such licenses or upon earlier termination by the parties. The issued patents covered by
these licenses expire at various dates ranging from 2006 to 2022. If one or more of these licenses
is terminated, we may be delayed in our efforts, or be unable, to develop and market the products
that are covered by the applicable license or licenses.
We may become involved in expensive patent litigation or other proceedings, which could result in
our incurring substantial costs and expenses or substantial liability for damages or require us to
stop our development and commercialization efforts.
There has been substantial litigation and other proceedings regarding patent and other
intellectual property rights in the biotechnology industry. We may become a party to various types
of patent litigation or other proceedings regarding intellectual property rights from time to time
even under circumstances in which we are not practicing and do not intend to practice any of the
intellectual property involved in the proceedings. For instance, in 2002, 2003, and 2005, we became
involved in two interference proceedings declared by the United States Patent and Trademark Office,
or USPTO, for certain of our antisense and ribozyme patents. All of these interferences have since
been resolved. We are neither practicing nor intending to practice the intellectual property that
is associated with any of these interference proceedings.
The cost to us of any patent litigation or other proceeding, including the interferences
referred to above, even if resolved in our favor, could be substantial. Some of our competitors may
be able to sustain the cost of such litigation or proceedings more effectively than we can because
of their substantially greater financial resources. If any patent litigation or other proceeding is
resolved against us, we or our collaborators may be enjoined from developing, manufacturing,
selling or importing our drugs without a license from the other party and we may be held liable for
significant damages. We may not be able to obtain any required license on commercially acceptable
terms or at all.
Uncertainties resulting from the initiation and continuation of patent litigation or other
proceedings could have a material adverse effect on our ability to compete in the marketplace.
Patent litigation and other proceedings may also absorb significant management time.
Risks Relating to Product Manufacturing, Marketing and Sales and Reliance on Third Parties
Because we have limited manufacturing experience, we are dependent on third-party manufacturers to
manufacture products for us. If we cannot rely on third-party manufacturers, we will be required to
incur significant costs and devote significant efforts to establish our own manufacturing
facilities and capabilities.
We have limited manufacturing experience and no commercial scale manufacturing capabilities.
In order to continue to develop our products, apply for regulatory approvals and ultimately
commercialize products, we need to develop, contract for or otherwise arrange for the necessary
manufacturing capabilities.
We currently rely upon third parties to produce material for preclinical and clinical testing
purposes and expect to continue to do so in the future. We also expect to rely upon third parties
to produce materials that may be required for the commercial production of our products.
There are a limited number of manufacturers that operate under the FDAs current good
manufacturing practices regulations capable of manufacturing our products. As a result, we may have
difficulty finding manufacturers for our products with adequate capacity for our needs. If we are
unable to arrange for third-party manufacturing of our products on a timely basis, or to do so on
commercially reasonable terms, we may not be able to complete development of our products or market
them.
-9-
Reliance on third-party manufacturers entails risks to which we would not be subject if we
manufactured products ourselves, including:
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reliance on the third party for regulatory compliance and quality assurance, |
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the possibility of breach of the manufacturing agreement by the third party because of
factors beyond our control, |
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the possibility of termination or nonrenewal of the agreement by the third party, based
on its own business priorities, at a time that is costly or inconvenient for us, |
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the potential that any such third-party manufacturer will develop know-how owned by
such third party in connection with the production of our products that is necessary for
the manufacture of our products, and |
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reliance upon third-party manufacturers to assist us in preventing inadvertent
disclosure or theft of our proprietary knowledge. |
We purchased oligonucleotides for preclinical and clinical testing from Avecia Biotechnology
at a preferential price under a supply agreement, which expired in March 2004. We have continued to
purchase all of the oligonucleotides we are using in our ongoing clinical trials and preclinical
testing from Avecia. The terms of the agreement have been extended until such time as a new
agreement is negotiated. If Avecia determines not to accept any purchase order for oligonucleotides
or we are unable to enter into a new manufacturing arrangement with Avecia or a new contract
manufacturer on a timely basis or at all, our ability to supply the product needed for our clinical
trials could be materially impaired.
We have no experience selling, marketing or distributing products and no internal capability to do
so.
If we receive regulatory approval to commence commercial sales of any of our products, we will
face competition with respect to commercial sales, marketing and distribution. These are areas in
which we have no experience. To market any of our products directly, we would need to develop a
marketing and sales force with technical expertise and with supporting distribution capability. In
particular, we would need to recruit a large number of experienced marketing and sales personnel.
Alternatively, we could engage a pharmaceutical or other healthcare company with an existing
distribution system and direct sales force to assist us. However, to the extent we entered into
such arrangements, we would be dependent on the efforts of third parties. If we are unable to
establish sales and distribution capabilities, whether internally or in reliance on third parties,
our business would suffer materially.
If third parties on whom we rely for clinical trials do not perform as contractually required or as
we expect, we may not be able to obtain regulatory approval for or commercialize our products and
our business may suffer.
We do not have the ability to independently conduct the clinical trials required to obtain
regulatory approval for our products. We depend on independent clinical investigators, contract
research organizations and other third-party service providers in the conduct of the clinical
trials of our products and expect to continue to do so. For example, we have contracted with
PAREXEL International to manage our Phase 2 clinical trial of IMO-2055 in renal cell carcinoma. We
rely heavily on these parties for successful execution of our clinical trials, but do not control
many aspects of their activities. We are responsible for ensuring that each of our clinical trials
is conducted in accordance with the general investigational plan and protocols for the trial.
Moreover, the FDA requires us to comply with standards, commonly referred to as good clinical
practices, for conducting, recording and reporting clinical trials to assure that data and reported
results are credible and accurate and that the rights, integrity and confidentiality of trial
participants are protected. Our reliance on third parties that we do not control does not relieve
us of these responsibilities and requirements. Third parties may not complete activities on
schedule or may not conduct our clinical trials in accordance with regulatory requirements or our
stated protocols. The failure of these third parties to carry out their obligations could delay or
prevent the development, approval and commercialization of our products. If we seek to conduct any
of these activities ourselves in the future, we will need to recruit appropriately trained
personnel and add to our infrastructure.
-10-
If we are unable to obtain adequate reimbursement from third-party payors for any products that we
may develop or acceptable prices for those products, our revenues and prospects for profitability
will suffer.
Most patients will rely on Medicare and Medicaid, private health insurers and other
third-party payors to pay for their medical needs, including any drugs we may market. If
third-party payors do not provide adequate coverage or reimbursement for any products that we may
develop, our revenues and prospects for profitability will suffer. Congress recently enacted a
limited prescription drug benefit for Medicare recipients in the Medicare Prescription Drug and
Modernization Act of 2003. While the program established by this statute may increase demand for
our products, if we participate in this program, our prices will be negotiated with drug
procurement organizations for Medicare beneficiaries and are likely to be lower than we might
otherwise obtain. Non-Medicare third-party drug procurement organizations may also base the price
they are willing to pay on the rate paid by drug procurement organizations for Medicare
beneficiaries.
A primary trend in the United States healthcare industry is toward cost containment. In
addition, in some foreign countries, particularly the countries of the European Union, the pricing
of prescription pharmaceuticals is subject to governmental control. In these countries, pricing
negotiations with governmental authorities can take six to twelve months or longer after the
receipt of regulatory marketing approval for a product. To obtain reimbursement or pricing approval
in some countries, we may be required to conduct a clinical trial that compares the cost
effectiveness of our product candidates or products to other available therapies. The conduct of
such a clinical trial could be expensive and result in delays in commercialization of our products.
Third-party payors are challenging the prices charged for medical products and services, and
many third-party payors limit reimbursement for newly-approved healthcare products. In particular,
third-party payors may limit the indications for which they will reimburse patients who use any
products that we may develop. Cost control initiatives could decrease the price we might establish
for products that we may develop, which would result in lower product revenues to us.
We face a risk of product liability claims and may not be able to obtain insurance.
Our business exposes us to the risk of product liability claims that is inherent in the
manufacturing, testing and marketing of human therapeutic drugs. Although we have product liability
and clinical trial liability insurance that we believe is adequate, this insurance is subject to
deductibles and coverage limitations. We may not be able to obtain or maintain adequate protection
against potential liabilities. If we are unable to obtain insurance at acceptable cost or otherwise
protect against potential product liability claims, we will be exposed to significant liabilities,
which may materially and adversely affect our business and financial position. These liabilities
could prevent or interfere with our commercialization efforts.
Risks Relating to an Investment in Our Common Stock
Our corporate governance structure, including provisions in our certificate of incorporation, our
by-laws, our stockholder rights plan and Delaware law, may prevent a change in control or
management that stockholders may consider desirable.
Section 203 of the Delaware General Corporation Law and our certificate of incorporation,
by-laws and stockholder rights plan contain provisions that might enable our management to resist a
takeover of our company or discourage a third party from attempting to take over our company. These
provisions include:
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a classified board of directors; |
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limitations on the removal of directors; |
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limitations on stockholder proposals at meetings of stockholders; |
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the inability of stockholders to act by written consent or to call special meetings; and |
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the ability of our board of directors to designate the terms of and issue new series of
preferred stock without stockholder approval. |
These provisions could have the effect of delaying, deferring, or preventing a change in
control of us or a change in our management that stockholders may consider favorable or beneficial.
These provisions could also discourage proxy contests and make it more difficult for you and other
stockholders to elect directors and take other corporate actions. These provisions could also limit
the price that investors might be willing to pay in the future for shares of our common stock.
Our stock price has been and may in the future be extremely volatile. In addition, because an
active trading market for our common stock has not developed, our investors ability to trade our
common stock may be limited. As a result, investors may lose all or a significant portion of their
investment.
Our stock price has been volatile. During the period from January 1, 2005 to June 30, 2006,
the closing sales price of our common stock, as adjusted to reflect a one-for-eight reverse split
of our common stock effected on June 29, 2006, ranged from a high of $6.48 per share to a low of
$2.88 per share. The stock market has also experienced significant price and volume fluctuations,
and the market prices of biotechnology companies in particular have been highly volatile, often for
reasons that have been unrelated to the operating performance of particular companies. The market
price for our common stock may be influenced by many factors, including:
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results of clinical trials of our product candidates or those of our competitors; |
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the regulatory status of our product candidates; |
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failure of any of our product candidates, if approved, to achieve commercial success; |
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the success of competitive products or technologies; |
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regulatory developments in the United States and foreign countries; |
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developments or disputes concerning patents or other proprietary rights; |
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the departure of key personnel; |
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variations in our financial results or those of companies that are perceived to be similar to us; |
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our cash resources; |
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the terms of any financing conducted by us; |
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changes in the structure of healthcare payment systems; |
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market conditions in the pharmaceutical and biotechnology sectors and issuance of new
or changed securities analysts reports or recommendations; and |
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general economic, industry and market conditions. |
In addition, our common stock has historically been traded at low volume levels and may
continue to trade at low volume levels. As a result, any large purchase or sale of our common stock
could have a significant impact on the price of our common stock and it may be difficult for
investors to sell our common stock in the market without depressing the market price for the common
stock or at all.
As a result of the foregoing, investors may not be able to resell their shares at or above the
price they paid for such shares. Investors in our common stock must be willing to bear the risk of
fluctuations in the price of our common stock and the risk that the value of their investment in
our stock could decline.
-12-
We may be unable to repay our 4% convertible subordinated notes when due or to repurchase the
convertible subordinated notes if we are required to do so under the terms of our agreement with
the holders of the 4% convertible subordinated notes.
In May 2005, we sold approximately $5.0 million in principal amount of 4% convertible
subordinated notes. On April 30, 2008, the entire outstanding principal amount of our 4%
convertible subordinated notes will become due and payable, unless the notes are converted to
common stock prior to expiration. In addition, we may be required to redeem all or part of the
convertible subordinated notes prior to the final maturity date if specified events occur. We may
not have sufficient funds or may be unable to arrange for additional financing to pay the amount
due under the convertible subordinated notes at maturity or to pay the price to repurchase the
convertible subordinated notes. Any future borrowing arrangements or debt agreements to which we
may become a party may restrict or prohibit us from repaying or repurchasing the convertible
subordinated notes. If we are prohibited from repaying or repurchasing the convertible subordinated
notes, we could try to obtain the consent of lenders under those arrangements, or we could attempt
to refinance the indebtedness that contains the restrictions. If we could not obtain the necessary
consents or refinance the indebtedness, we would be unable to repay or repurchase the convertible
subordinated notes. Any such failure would constitute an event of default under the agreement with
the holders of the 4% convertible subordinated notes, which could, in turn, constitute a default
under the terms of any future indebtedness.
You may suffer additional dilution if we issue additional shares to the selling stockholder under
the Common Stock Purchase Agreement.
In March 2006, we entered into a Common Stock Purchase Agreement with the selling stockholder.
Under this agreement, we secured a commitment from the selling stockholder to purchase from us up
to a total of $9.75 million of our common stock during the period from June 24, 2006 through
December 31, 2006 in up to three drawdowns made by us, at our discretion. In each drawdown, the
shares of common stock will be sold at a price equal to 80% of the volume weighted average of the
closing prices of the common stock on the five trading days preceding the drawdown notice, but such
purchase price in no event will be less than a floor price of $5.12 per share. Based on this floor
price, a maximum of 1,904,296 shares of common stock could be issued under the commitment. We are
not obligated to sell any of the remaining $6.25 million of common stock available under the
commitment and there are no minimum commitments or minimum use penalties. If we issue shares of
our common stock to the selling stockholder pursuant to the commitment, our then existing
stockholders will experience dilution.
-13-
SPECIAL NOTE REGARDING FORWARD-LOOKING INFORMATION
This prospectus and the documents we incorporate by reference contain forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. All statements, other than statements of historical facts,
included or incorporated in this prospectus regarding our strategy, future operations, financial
position, future revenues, projected costs, prospects, plans and objectives of management are
forward-looking statements. The words anticipates, believes, estimates, expects, intends,
may, plans, projects, will, would and similar expressions are intended to identify
forward-looking statements, although not all forward-looking statements contain these identifying
words. We may not actually achieve the plans, intentions or expectations disclosed in our
forward-looking statements and you should not place undue reliance on our forward-looking
statements. Actual results or events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements we make. We have included important
factors in the cautionary statements included in this prospectus, particularly under the heading
Risk Factors, that we believe could cause actual results or events to differ materially from the
forward-looking statements that we make. In addition, any forward-looking statements represent our
estimates only as of the date this prospectus is filed with the SEC and should not be relied upon
as representing our estimates as of any subsequent date. We do not assume any obligation to update
any forward-looking statements.
USE OF PROCEEDS
We will not receive any proceeds from the sale of the shares offered pursuant to this
prospectus. The selling stockholder will receive all of the proceeds from the sale of the shares of
common stock offered by this prospectus. For information about the selling stockholder, see
Selling Stockholder.
The selling stockholder will pay any underwriting discounts and commissions and expenses
incurred by the selling stockholder for brokerage, accounting, tax or legal services or any other
expenses incurred by the selling stockholder in disposing of the shares. We will bear all other
costs, fees and expenses incurred in effecting the registration of the shares covered by this
prospectus, including all registration and filing fees and fees and expenses of our counsel and our
accountants.
SELLING STOCKHOLDER
The shares of common stock covered by this prospectus consist of 683,593 shares of common
stock issued to the selling stockholder on July 25, 2006. The table below sets forth, to our
knowledge, information about the selling stockholder as of July 26, 2006.
We do not know when or in what amounts the selling stockholder may offer shares for sale. The
selling stockholder may sell any or all of the shares offered by this prospectus. Because the
selling stockholder may offer all or some of the shares pursuant to this offering, and because
there are currently no agreements, arrangements or understandings with respect to the sale of any
of the shares, we cannot estimate the number of shares that will be held by the selling stockholder
after completion of this offering. For purposes of this table, however, we have assumed that, after
completion of this offering, none of the shares covered by this prospectus will be held by the
selling stockholder.
Beneficial ownership is determined in accordance with the rules of the SEC, and includes
voting or investment power with respect to shares. Shares of common stock issuable upon exercise
of warrants or stock options that are exercisable within 60 days after July 26, 2006 are deemed
outstanding for computing the percentage ownership of the person holding the warrants or options
but are not deemed outstanding for computing the percentage ownership of any other person. Unless
otherwise indicated below, to our knowledge, all persons named in the table have sole voting and
investment power with respect to the shares of common stock beneficially owned by them, except to
the extent authority is shared by spouses under applicable law. The inclusion of any shares in this
table does not constitute an admission of beneficial ownership for the person named below.
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Shares of Common Stock |
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Number of Shares of |
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Shares of Common Stock to be |
Name of Selling Stockholder |
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Beneficially Owned Prior to |
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of Common Stock |
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Beneficially Owned After |
(1) |
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Offering |
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Being Offered |
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Offering |
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Number |
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Percentage |
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Number |
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Percentage |
Biotech Shares Ltd. |
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1,445,311 |
(2) |
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8.0 |
% |
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683,593 |
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761,718 |
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4.2 |
% |
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(1) |
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The term selling stockholder includes donees, pledgees, transferees or other
successors-in-interest selling shares received after the date of this prospectus from the selling
stockholder as a gift, pledge, partnership distribution or other non-sale related transfer. |
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(2) |
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Includes 761,718 shares of common stock issuable upon the exercise of warrants held by Biotech
Shares Ltd. |
Relationship with Selling Stockholder
The selling stockholder has not had any position, office or other material relationship with
us or our affiliates.
DESCRIPTION OF CAPITAL STOCK
We are authorized to issue 40,000,000 shares of common stock and 5,000,000 shares of preferred
stock, $0.01 par value per share, of which 1,500,000 are designated series A convertible preferred
stock and 200,000 shares are designated series C junior participating preferred stock. As of June
30, 2006, there were 16,721,124 shares of common stock outstanding, 655 shares of series A
convertible preferred stock outstanding, no shares of series C junior participating preferred stock
outstanding and no other shares of preferred stock issued and outstanding.
The material terms and provisions of our common stock, our preferred stock, our preferred
stock purchase rights and each other class of our securities that qualifies or limits our common
stock, are described in our Registration Statement on Form 8-A dated December 4, 2003, which is
incorporated by reference in this prospectus. For the complete terms of our common stock,
preferred stock and preferred stock purchase rights, please refer to our certificate of
incorporation, by-laws and stockholder rights plan that we have filed with the SEC. The terms of
these securities may also be affected by the General Corporation Law of the State of Delaware.
PLAN OF DISTRIBUTION
The selling stockholder may offer and sell the shares covered by this prospectus from time to
time. The term selling stockholder includes donees, pledgees, transferees or other
successors-in-interest selling shares received after the date of this prospectus from the selling
stockholder as a gift, pledge, partnership distribution or other transfer. The selling stockholder
will act independently of us in making decisions with respect to the timing, manner and size of
each sale. Such sales may be made on one or more exchanges or in the over-the-counter market or
otherwise, at prices and under terms then prevailing or at prices related to the then current
market price or in negotiated transactions. The selling stockholder may sell its shares by one or
more of, or a combination of, the following methods:
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purchases by a broker-dealer as principal and resale by such broker-dealer for its
own account pursuant to this prospectus; |
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ordinary brokerage transactions and transactions in which the broker solicits
purchasers; |
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block trades in which the broker-dealer so engaged will attempt to sell the shares
as agent but may position and resell a portion of the block as principal to facilitate
the transaction; |
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an over-the-counter distribution; |
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in privately negotiated transactions; and |
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in options transactions. |
In addition, the selling stockholder may sell any shares that qualify for sale pursuant to
Rule 144 under Rule 144 rather than pursuant to this prospectus.
In connection with distributions of the shares or otherwise, the selling stockholder may enter
into hedging transactions with broker-dealers or other financial institutions. In connection with
such transactions, broker-dealers or other financial institutions may engage in short sales of the
common stock in the course of hedging the positions they assume with the selling stockholder. The
selling stockholder may also sell the common stock short and redeliver the shares to close out such
short positions. The selling stockholder may also enter into option or other transactions with
broker-dealers or other financial institutions which require the delivery to such broker-dealer or
other financial institution of shares offered by this prospectus, which shares such broker-dealer
or other financial institution may resell pursuant to this prospectus, as supplemented or amended
to reflect such transaction. The selling stockholder may also pledge shares to a broker-dealer or
other financial institution, and, upon a default, such broker-dealer or other financial
institution, may effect sales of the pledged shares pursuant to this prospectus, as supplemented or
amended to reflect such transaction. In effecting sales, broker-dealers or agents engaged by the
selling stockholder may arrange for other broker-dealers to participate. Broker-dealers or agents
may receive commissions, discounts or concessions from the selling stockholder in amounts to be
negotiated immediately prior to the sale.
In offering the shares covered by this prospectus, the selling stockholder and any
broker-dealers who execute sales for the selling stockholder may be deemed to be underwriters
within the meaning of the Securities Act in connection with such sales. Any profits realized by the
selling stockholder and the compensation of any broker-dealers may be deemed to be underwriting
discounts and commissions.
In order to comply with the securities laws of some states, if applicable, the shares must be
sold in those states only through registered or licensed brokers or dealers. In addition, some
states may restrict the selling stockholder from selling its shares unless the shares have been
registered or qualified for sale in the applicable state or an exemption from the registration or
qualification requirement is available and is complied with.
We have advised the selling stockholder 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
stockholder and its affiliates. In addition, we will make copies of this prospectus available to
the selling stockholder for the purpose of satisfying the prospectus delivery requirements of the
Securities Act. The selling stockholder may indemnify any broker-dealer that participates in
transactions involving the sale of the shares against some liabilities, including liabilities
arising under the Securities Act.
At the time a particular offer of shares is made, if required, we will distribute a prospectus
supplement that will set forth the number of shares being offered and the terms of this offering,
including the name of any underwriter, dealer or agent, the purchase price paid by any underwriter,
any discount, commission and other item constituting compensation, any discount, commission or
concession allowed or reallowed or paid to any dealer, and the proposed selling price to the
public. In addition, we may amend or supplement this prospectus from time to time to describe a
specific plan of distribution.
We have agreed to indemnify the selling stockholder against some liabilities, including some
liabilities under the Securities Act.
We have agreed with the selling stockholder to use our best efforts to cause the registration
statement of which this prospectus constitutes a part to remain effective until the earlier of:
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such time as all of the shares covered by this prospectus and held by the selling
stockholder are eligible to be sold under Rule 144 of the Securities Act without
restriction by the volume limitations of Rule 144(e) of the Securities Act; and |
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such time as all of the shares covered by this prospectus have been sold pursuant to
the registration statement of which this prospectus constitutes a part, to or through a
broker or dealer or underwriter in a public securities transaction or in a transaction
exempt from the registration and prospectus delivery requirements of the Securities Act
such that all transfer restrictions and restrictive legends, if any, are removed upon
the consummation of such sale. |
LEGAL MATTERS
The validity of the shares offered by this prospectus has been passed upon by Wilmer Cutler
Pickering Hale and Dorr LLP.
EXPERTS
Ernst & Young LLP, independent registered public accounting firm, has audited our consolidated
financial statements included in our Annual Report on Form 10-K for the years ended December 31,
2005, 2004 and 2003, as set forth in their report, which is incorporated by reference in this
registration statement. Our financial statements as of and for the years ended December 31, 2005,
2004 and 2003 are incorporated by reference in reliance on Ernst & Young LLPs report, given on
their authority as experts in accounting and auditing.
MATERIAL CHANGES
On June 29, 2006, we effected a one-for-eight reverse stock split of our issued and
outstanding common stock. The following selected financial data reflects this reverse stock split.
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Quarter Ended |
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Year Ended |
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Mar. 31 |
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Mar. 31 |
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Dec. 31 |
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Dec. 31 |
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Dec. 31 |
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2006 |
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2005 |
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|
2005 |
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2004 |
|
|
2003 |
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|
|
|
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|
(In thousands, except per share data) |
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|
Basic and diluted net (loss) per
common share from: |
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|
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|
|
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|
Net (loss) per share |
|
$ |
(0.26 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.99 |
) |
|
$ |
(1.03 |
) |
|
$ |
(2.70 |
) |
Accretion of preferred stock dividends |
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|
|
|
|
|
|
|
|
|
|
|
|
|
(0.22 |
) |
|
|
(0.86 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) per share applicable
to common stockholders |
|
$ |
(0.26 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.99 |
) |
|
$ |
(1.25 |
) |
|
$ |
(3.56 |
) |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and
diluted net (loss) per common
share |
|
|
14,154 |
|
|
|
13,871 |
|
|
|
13,886 |
|
|
|
12,364 |
|
|
|
6,382 |
|
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|
|
|
|
|
|
|
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|
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|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common shares outstanding end of period |
|
|
16,716 |
|
|
|
13,876 |
|
|
|
13,928 |
|
|
|
13,866 |
|
|
|
8,810 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options outstanding end of period |
|
|
2,527 |
|
|
|
2,074 |
|
|
|
2,548 |
|
|
|
2,070 |
|
|
|
1,840 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
purchase warrants outstanding end
of year |
|
|
|
|
|
|
|
|
|
|
2,010 |
|
|
|
1,940 |
|
|
|
1,295 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of common shares issuable upon
conversion of 4% notes end of period |
|
|
707 |
|
|
|
|
|
|
|
707 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
|
|
|
|
|
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|
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|
Number of common shares that preferred
stock can be converted into end of
period |
|
|
2 |
|
|
|
2 |
|
|
|
2 |
|
|
|
2 |
|
|
|
1,439 |
|
|
|
|
|
|
|
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|
-17-
WHERE YOU CAN FIND MORE INFORMATION
We file reports, proxy statements and other documents with the SEC. You may read and copy any
document we file at the SECs public reference room at 100 F Street, N.E., Room 1580, Washington,
D.C. 20549. You should call 1-800-SEC-0330 for more information on the public reference room. Our
SEC filings are also available to you on the SECs Internet site at http://www.sec.gov.
This prospectus is part of a registration statement that we filed with the SEC. The
registration statement contains more information than this prospectus regarding us and our common
stock, including certain exhibits and schedules. You can obtain a copy of the registration
statement from the SEC at the address listed above or from the SECs Internet site.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The SEC requires us to incorporate into this prospectus information that we file with the
SEC in other documents. This means that we can disclose important information to you by referring
to other documents that contain that information. The information incorporated by reference is
considered to be part of this prospectus. Information contained in this prospectus and information
that we file with the SEC in the future and incorporate by reference in this prospectus
automatically updates and supersedes previously filed information. We incorporate by reference the
documents listed below and any future filings we make with the SEC under Sections 13(a), 13(c), 14
or 15(d) of the Securities Exchange Act of 1934, prior to the sale of all the shares covered by
this prospectus.
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(1) |
|
Our Annual Report on Form 10-K for the year ended December 31,
2005; |
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(2) |
|
Our Quarterly Report on Form 10-Q for the quarter ended March
31, 2006; |
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|
(3) |
|
Our Current Report on Form 8-K dated March 29, 2006; |
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|
(4) |
|
Our Current Report on Form 8-K dated April 19, 2006; |
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(5) |
|
Our Current Report on Form 8-K dated June 8, 2006; |
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(6) |
|
Our Current Report on Form 8-K dated July 6, 2006; |
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(7) |
|
Our Current Report on Form 8-K dated July 14, 2006; |
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(8) |
|
The description of our capital stock contained in our
Registration Statement on Form 8-A dated December 4, 2003, including any
amendments or reports filed for the purpose of updating that description; and |
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(9) |
|
All of our filings pursuant to the Exchange Act after the date
of filing the initial registration statement and prior to effectiveness of the
registration statement. |
You may request a copy of these documents, which will be provided to you at no cost, by
writing or telephoning us using the following contact information below. We will provide copies of
the exhibits to these filings only if they are specifically incorporated by reference in these
filings.
Idera Pharmaceuticals, Inc.
345 Vassar Street
Cambridge, Massachusetts 02139
Attention: Investor Relations
(617) 679-5500
-18-
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
The following table sets forth the various expenses to be incurred in connection with the sale
and distribution of the securities being registered hereby (except any underwriting discounts and
commissions), all of which will be borne by Idera Pharmaceuticals. All amounts shown are estimates
except the SEC registration fee.
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|
Filing Fee Securities and Exchange Commission |
|
$ |
211 |
|
Legal fees and expenses |
|
|
50,000 |
|
Accounting fees and expenses |
|
|
10,000 |
|
Miscellaneous expenses |
|
|
10,000 |
|
|
|
|
|
Total Expenses |
|
$ |
70,211 |
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|
Item 15. Indemnification of Directors and Officers.
Article EIGHTH of the Registrants Restated Certificate of Incorporation provides that no
director of the Registrant shall be personally liable for any monetary damages for any breach of
fiduciary duty as a director, except to the extent that the Delaware General Corporation Law
prohibits the elimination or limitation of liability of directors for breach of fiduciary duty.
Article NINTH of the Registrants Restated Certificate of Incorporation provides that a
director or officer of the Registrant (a) shall be indemnified by the Registrant against all
expenses (including attorneys fees), judgments, fines and amounts paid in settlement incurred in
connection with any litigation or other legal proceeding (other than an action by or in the right
of the Registrant) brought against him by virtue of his position as a director or officer of the
Registrant if he acted in good faith and in a manner he reasonably believed to be in, or not
opposed to, the best interests of the Registrant, and, with respect to any criminal action or
proceeding, had no reasonable cause to believe his conduct was unlawful and (b) shall be
indemnified by the Registrant against all expense (including attorneys fees) and amounts paid in
settlement incurred in connection with any action by or in the right of the Registrant brought
against him by virtue of his position as a director or officer of the Registrant if he acted in
good faith and in a manner he reasonably believed to be in, or not opposed to, the best interests
of the Registrant, except that no indemnification shall be made with respect to any matter as to
which such person shall have been adjudged to be liable to the Registrant, unless a court
determines that, despite such adjudication but in view of all of the circumstances, he is entitled
to indemnification of such expenses. Notwithstanding the foregoing, to the extent that a director
or officer has been successful, on the merits or otherwise, including, without limitation, the
dismissal of an action without prejudice, he is required to be indemnified by the Registrant
against all expenses (including attorneys fees) incurred in connection therewith. Expenses shall
be advanced to a director or officer at his request, provided that he undertakes to repay the
amount advanced if it is ultimately determined that he is not entitled to indemnification for such
expenses.
Indemnification is required to be made unless the Registrant determines that the applicable
standard of conduct required for indemnification has not been met. In the event of a determination
by the Registrant that the director or officer did not meet the applicable standard of conduct
required for indemnification, or if the Registrant fails to make an indemnification payment within
60 days after such payment is claimed by such person, such person is permitted to petition the
court to make an independent determination as to whether such person is entitled to
indemnification. As a condition precedent to the right of indemnification, the director or officer
must give the Registrant notice of the action for which indemnity is sought and the Registrant has
the right to participate in such action or assume the defense thereof.
II-1
Article NINTH of the Registrants Restated Certificate of Incorporation further provides that
the indemnification provided therein is not exclusive, and provides that in the event that the
Delaware General Corporation Law is amended to expand the indemnification permitted to directors or
officers the Registrant must indemnify those persons to the full extent permitted by such law as so
amended.
Section 145 of the Delaware General Corporation law provides that a corporation has the power
to indemnify a director, officer, employee or agent of the corporation and certain other persons
serving at the request of the corporation in related capacities against amounts paid and expense
incurred in connection with an action or proceeding to which he is or is threatened to be made a
party by reason of such position, if such person shall have acted in good faith and in a manner he
reasonably believed to be in or not opposed to the best interests of the corporation, and, in any
criminal proceeding, if such person had no reasonable cause to believe his conduct was unlawful;
provided that, in the case of actions brought by or in the right of the corporation, no
indemnification shall be made with respect to any matter as to which such person shall have been
adjudged to be liable to the corporation unless and only to the extent that the adjudicating court
determines that such indemnification is proper under the circumstances.
Idera Pharmaceuticals has obtained directors and officers insurance for the benefit of its
directors and its officers.
Item 16. Exhibits
The exhibits listed in the Exhibit Index immediately preceding the exhibits are filed as part
of this Registration Statement on Form S-3.
Item 17. Undertakings.
The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a post-effective
amendment to this Registration Statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of
1933, as amended (the Securities Act);
(ii) To reflect in the prospectus any facts or events arising after the effective
date of this Registration Statement (or the most recent post-effective amendment
thereof) which, individually or in the aggregate, represent a fundamental change in the
information set forth in this Registration Statement. Notwithstanding the foregoing,
any increase or decrease in the volume of securities offered (if the total dollar value
of securities offered would not exceed that which was registered) and any deviation from
the low or high end of the estimated maximum offering range may be reflected in the form
of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate,
the changes in volume and price represent no more than 20 percent change in the maximum
aggregate offering price set forth in the Calculation of Registration Fee table in the
effective Registration Statement; and
(iii) To include any material information with respect to the plan of distribution
not previously disclosed in this Registration Statement or any material change to such
information in this Registration Statement;
provided, however, that paragraphs (1)(i) and (1)(ii) do not apply if the information required to
be included in a post-effective amendment by those paragraphs is contained in periodic reports
filed with or furnished to the Commission by the Registrant pursuant to Section 13 or Section 15(d)
of the Securities Exchange Act of 1934, as amended (the Exchange Act), that are incorporated by
reference in this Registration Statement.
II-2
(2) That, for the purposes of determining any liability under the Securities Act, each
post-effective amendment shall be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at the time shall be deemed to be
the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities
being registered which remain unsold at the termination of the offering.
The Registrant hereby undertakes that, for purposes of determining any liability under the
Securities Act, each filing of the Registrants annual report pursuant to Section 13(a) or 15(d) of
the Exchange Act (and, where applicable, each filing of an employee benefit plans annual report
pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in this
Registration Statement shall be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted
to directors, officers and controlling persons of the Registrant pursuant to the indemnification
provisions described herein, or otherwise, the Registrant has been advised that in the opinion of
the Securities and Exchange Commission such indemnification is against public policy as expressed
in the Securities Act and is, therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by the Registrant of expenses
incurred or paid by a director, officer or controlling person of the Registrant in the successful
defense of any action, suit or proceeding) is asserted by such director, officer or controlling
person in connection with the securities being registered, the Registrant will, unless in the
opinion of its counsel the matter has been settled by controlling precedent, submit to a court of
appropriate jurisdiction the question whether such indemnification by it is against public policy
as expressed in the Securities Act and will be governed by the final adjudication of such issue.
II-3
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended, the Registrant
certifies that it has reasonable grounds to believe that it meets all of the requirements for
filing on Form S-3 and has duly caused this Registration Statement to be signed on its behalf by
the undersigned, thereunto duly authorized, in the City of Cambridge, Commonwealth of
Massachusetts, on July 27, 2006.
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|
IDERA PHARMACEUTICALS, INC. |
|
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By:
|
|
/s/ Sudhir Agrawal |
|
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|
Sudhir Agrawal, D. Phil. |
|
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|
Chief Executive Officer |
SIGNATURES AND POWER OF ATTORNEY
We, the undersigned officers and directors of Idera Pharmaceuticals, Inc., hereby severally
constitute and appoint Robert G. Andersen and Sudhir Agrawal and each of them singly, our true and
lawful attorneys with full power to any of them, and to each of them singly, to sign for us and in
our names in the capacities indicated below the Registration Statement on Form S-3 filed herewith
and any and all pre-effective and post-effective amendments to said Registration Statement and
generally to do all such things in our name and behalf in our capacities as officers and directors
to enable Idera Pharmaceuticals, Inc. to comply with the provisions of the Securities Act of 1933,
as amended, and all requirements of the Securities and Exchange Commission, hereby ratifying and
confirming our signatures as they may be signed by our said attorneys, or any of them, to said
Registration Statement and any and all amendments thereto.
Pursuant to the requirements of the Securities Act of 1933, as amended, this Registration
Statement has been signed by the following persons in the capacities and on the dates indicated.
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Signature |
|
Title |
|
Date |
|
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|
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/s/ James B. Wyngaarden
|
|
Chairman of the Board of Directors
|
|
July 27, 2006 |
James B. Wyngaarden, M.D.
|
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/s/ Sudhir Agrawal
|
|
Chief Executive Officer, Chief Scientific Officer and
|
|
July 27, 2006 |
|
|
Director
(Principal Executive Officer)
|
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|
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|
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/s/ Robert W. Karr
|
|
President and Director
|
|
July 27, 2006 |
|
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|
|
/s/ Robert G. Andersen
|
|
Chief Financial Officer, Vice President of
|
|
July 27, 2006 |
|
|
Operations,
Treasurer and Secretary (Principal
|
|
|
|
|
Financial and Accounting Officer) |
|
|
|
|
|
|
|
/s/ Youssef El-Zein
|
|
Director
|
|
July 27, 2006 |
|
|
|
|
|
II-4
|
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|
|
/s/ C. Keith Hartley |
|
Director
|
|
July 27, 2006 |
|
|
|
|
|
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|
|
|
|
/s/ William S. Reardon
|
|
Director
|
|
July 27, 2006 |
|
|
|
|
|
|
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|
|
/s/ Alison Taunton-Rigby
|
|
Director
|
|
July 27, 2006 |
Alison Taunton-Rigby, Ph.D.
|
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|
II-5
EXHIBIT INDEX
|
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|
EXHIBIT |
|
|
NUMBER |
|
DESCRIPTION |
|
|
|
|
|
|
4.1 |
(1) |
|
Restated Certificate of Incorporation of the Registrant, as amended. |
|
|
|
|
|
|
4.2 |
(2) |
|
Certificate of Amendment to Restated Certificate of Incorporation,
dated June 29, 2006 |
|
|
|
|
|
|
4.3 |
(3) |
|
Amended and Restated By-laws of the Registrant.
|
|
|
|
|
|
|
4.4 |
(4) |
|
Rights Agreement dated December 10, 2001 between Idera Pharmaceuticals, Inc. and Mellon Investor Services LLC, as rights
agent. |
|
|
|
|
|
|
4.5 |
(5) |
|
Amendment No. 1 to Rights Agreement dated as of August 27, 2003
between the Registrant and Mellon Investor Services LLC. |
|
|
|
|
|
|
4.6 |
(6) |
|
Amendment No. 2 to Rights Agreement dated as of March 24, 2006
between the Registrant and Mellon Investor Services LLC. |
|
|
|
|
|
|
5.1 |
|
|
Opinion of Wilmer Cutler Pickering Hale and Dorr LLP. |
|
|
|
|
|
|
23.1 |
|
|
Consent of Ernst & Young LLP. |
|
|
|
|
|
|
23.2 |
|
|
Consent of Wilmer Cutler Pickering Hale and Dorr LLP, included in
Exhibit 5.1 filed herewith. |
|
|
|
|
|
|
24.1 |
|
|
Power of Attorney (See page II-4 of this Registration Statement). |
|
|
|
(1) |
|
Previously filed with the Securities and Exchange Commission as an Exhibit to the
Registrants Registration Statement on Form S-3, dated July 15, 2005, as amended (File No.
333-126634) and incorporated herein by reference. |
|
(2) |
|
Previously filed with the Securities and Exchange Commission as an Exhibit to the
Registrants Current Report of Form 8-K, dated July 6, 2006 (File No. 001-31918) and
incorporated herein by reference. |
|
(3) |
|
Previously filed with the Securities and Exchange Commission as an Exhibit to the
Registrants Registration Statement on Form S-1, dated November 6, 1995, as amended (File No.
33-99024) and incorporated herein by reference. |
|
(4) |
|
Previously filed with the Securities and Exchange Commission as an Exhibit to the
Registrants Registration Statement on Form S-2, dated October 10, 2003 (File No. 333-109630)
and incorporated herein by reference. |
|
(5) |
|
Previously filed with the Securities and Exchange Commission as an Exhibit to the
Registrants Current Report of Form 8-K, dated August 29, 2003 (File No. 000-27352) and
incorporated herein by reference. |
|
(6) |
|
Previously filed with the Securities and Exchange Commission as an Exhibit to the
Registrants Current Report of Form 8-K, dated March 29, 2006 (File No. 001-31918) and
incorporated herein by reference. |
II-6