e424b3
Filed Pursuant to Rule 424(b)(3)
Registration No. 333-134584
ALTEON INC.
21,920,800 SHARES OF COMMON STOCK
We sold shares of our common stock and warrants to purchase our common stock for an aggregate
purchase price of approximately $2.6 million in a private placement which closed on April 21, 2006.
This prospectus relates to the resale from time to time of up to a total of 21,920,800 shares of
our common stock by the selling stockholders described in the section entitled Selling
Stockholders on page 24 of this prospectus.
The selling stockholders will receive all of the proceeds from the disposition of the shares
or interests therein and will pay all underwriting discounts and selling commissions relating
thereto. We have agreed to pay the legal, accounting, printing and other expenses related to the
registration of the shares.
Our common
stock is listed on The American Stock Exchange under the symbol
ALT. On June 13,
2006, the last reported sale price of our common stock was $0.20 per share. Our principal executive
offices are located at 6 Campus Drive, Parsippany, New Jersey 07054, and our telephone number is
201-934-5000.
You
should consider carefully the risks that we have described in
Risk Factors beginning on
page 4 before deciding whether to invest in our common stock.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or passed upon the accuracy or adequacy of this
prospectus. Any representation to the contrary is a criminal offense.
THE DATE OF THIS PROSPECTUS IS June 14, 2006
TABLE OF CONTENTS
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ABOUT THIS PROSPECTUS
You should read this prospectus and the information and documents incorporated by reference
carefully. Such documents contain important information you should consider when making your
investment decision. See Incorporation of Certain Documents by
Reference on page 30. You should
rely only on the information provided in this prospectus or documents incorporated by reference
into this prospectus. We have not authorized anyone to provide you with different information. The
selling stockholders are offering to sell and seeking offers to buy shares of our common stock only
in jurisdictions in which 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 our common stock.
In this prospectus, we refer to Alteon Inc. as the Company or Alteon.
OUR BUSINESS
The following is only a summary. We urge you to read this entire prospectus, including the
more detailed consolidated financial statements, notes to the consolidated financial statements and
other information incorporated by reference from our other filings with the SEC. Investing in our
common stock involves risks. Therefore, please carefully consider the information provided under
the heading Risk Factors beginning on page 4.
Overview
We are a product-based biopharmaceutical company engaged in the development of small
molecule drugs to treat and prevent cardiovascular diseases and other diseases associated with
aging and diabetes. We have identified promising product candidates that we believe represent
novel potential approaches to some of the largest pharmaceutical markets. We have advanced one of
these products into Phase 2 clinical trials.
Our lead drug candidate, alagebrium chloride or alagebrium (formerly ALT-711), is a product of
our drug discovery and development program. Alagebrium has demonstrated potential efficacy in two
clinical trials in heart failure, as well as in animal models of
heart failure and nephropathy,
among others. It has been tested in approximately 1,000 patients in a number of Phase 1 and Phase
2 clinical trials. Our goal is to develop alagebrium to treat diastolic heart failure (DHF). This
disease represents a rapidly growing market of unmet need, particularly common among diabetic
patients, and alagebrium has demonstrated relevant clinical activity in two Phase 2 clinical
trials.
In April 2006, we announced the signing of a definitive merger agreement with HaptoGuard,
Inc., whereby the two companies will combine operations. The companies have complementary product
platforms in cardiovascular diseases, diabetes and other inflammatory diseases. We have begun
working with the HaptoGuard team in anticipation of the merger of the companies, and are preparing
a Phase 2 protocol for alagebrium in heart failure in order to expand our clinical program in this
therapeutic area. However, any continued development of alagebrium by us is contingent upon the
successful completion of the merger and adequate funding for product development.
Following the merger, the combined company will have two products in Phase 2 clinical
development:
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Alagebrium chloride (formerly ALT-711), Alteons lead compound, is an Advanced
Glycation End-product Crosslink Breaker being developed for heart failure. Data
presented from two Phase 2 clinical studies at the American Heart Association
meeting in November 2005 demonstrated the ability of alagebrium to improve overall
cardiac function, including measures of diastolic and endothelial function. In
these studies, alagebrium also demonstrated the ability to significantly reduce
left ventricular mass. The compound has been tested in approximately 1,000
patients, which represents a sizeable human safety database, in a number of Phase 2
clinical trials. |
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ALT-2074 (formerly BXT-51072), HaptoGuards licensed lead compound, is a
glutathione peroxidase mimetic in development for reduction of mortality in
post-myocardial infarction patients with diabetes. The compound has shown the
ability to reduce infarct size by approximately 85% in a mouse model of heart
attack called ischemia reperfusion injury. |
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Additionally, HaptoGuard owns a license to a proprietary genetic biomarker that has shown the
potential to identify patients who are most responsive to the HaptoGuard compound.
The merger of the two companies will be structured as an acquisition by Alteon. Under the
terms of the merger agreement, HaptoGuard shareholders will receive approximately 37.4 million
shares of Alteon common stock (approximately 31% of total shares after completion of the merger.)
As part of the merger, a portion of existing shares of Alteon preferred stock held by Genentech,
Inc. will be converted into common stock, among other transactions. The merger and preferred stock
restructuring transactions are subject to the approval of Alteon and HaptoGuard shareholders and
are expected to close early in the third quarter of 2006.
In April 2006, we also announced the signing of definitive agreements for a private equity
financing which resulted in gross proceeds to us of approximately $2.6 million. The private equity
financing includes new and existing institutional investors, in which we sold approximately 10.3
million Units, consisting of common stock and warrants, for net proceeds after expenses and fees of
approximately $2.5 million. Each Unit consists of one share of Alteon common stock and one warrant
to purchase one share of Alteon common stock. The Units were sold at a price of $0.25 per Unit and
the warrants are exercisable, commencing six months from the date of issuance, for a period of five
years at an exercise price of $0.30 per share. The shares of common stock and warrants that were
offered and sold in the financing were not registered under the Securities Act or state securities
laws pursuant to an exemption from registration provided by Regulation D under the Securities Act.
The Company has agreed to file this registration statement with the SEC for the resale of the
shares of common stock and the shares of common stock underlying the warrants sold in the private
equity financing. Rodman & Renshaw, LLC served as placement agent in the transaction and received a
6% placement fee which was paid in Units.
We were incorporated in Delaware in October 1986. Our headquarters are located at 6 Campus
Drive, Parsippany, New Jersey 07054. We maintain a web site at www.alteon.com and our telephone
number is (201) 934-5000. Our annual reports on Form 10-K, our quarterly reports on Form 10-Q, our
current reports on Form 8-K, and all amendments to those reports, are available to you free of
charge through the Investor Relations section of our website as soon as reasonably practicable
after such materials have been electronically filed with, or furnished to, the Securities and
Exchange Commission.
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RISK FACTORS
The following factors should be considered carefully in evaluating whether to purchase shares
of Alteon common stock. These factors should be considered in conjunction with any other
information included or incorporated by reference herein, including in conjunction with
forward-looking statements made herein. See Where You Can Find
More Information on Page 29.
RISKS RELATED TO OUR BUSINESS
As a result of a decrease in our available financial resources, we have significantly
curtailed the research, product development, preclinical testing and clinical trials of our product
candidates, and if we are unable to obtain sufficient additional funding in the near term, we may
be forced to cease operations.
As of March 31, 2006, we had working capital of $3,755,000, including $4,469,000 of cash and
cash equivalents. Our cash used in operating activities for the three months ended March 31, 2006
was $1,912,000.
On April 19, 2006, we signed a definitive merger agreement with HaptoGuard, Inc., whereby the
two companies will combine operations in a stock transaction valued at $8.8 million. As part of the
merger, a portion of our existing shares of preferred stock held by Genentech, Inc. will be
converted into common stock. In addition, on April 21, 2006, we closed an equity financing that
resulted in net proceeds to us of approximately $2.5 million. Assuming completion of the merger
between Alteon and HaptoGuard, we expect to utilize cash and cash equivalents to fund our operating
activities, and to fund the future clinical development efforts of the combined companies,
including the planned Phase 2 studies of our lead compound, alagebrium and HaptoGuards lead
compound ALT-2074.
While we intend to pursue development of alagebrium in high potential cardiovascular
indications such as heart failure, any continued development of alagebrium by us is contingent upon
our completion of the merger.
If we are unable to complete the merger and the preferred stock restructuring on reasonable
terms, we will not have the ability to continue as a going concern after late 2006. As part of the
merger, there are associated costs that will result in the Company being required to make payment
of certain obligations in the amount of approximately $2.0 million, including severance and other
contractual and regulatory requirements. Even if we complete the merger, there can be no assurance
that the products or technologies acquired in such transaction will result in revenues to the
combined company or any meaningful return on investment to our stockholders.
The amount and timing of our future capital requirements will depend on numerous factors,
including the timing of resuming our research and development programs, if at all, the timing of
completion of the merger with HaptoGuard, the number and characteristics of product candidates that
we pursue, the conduct of preclinical tests and clinical studies, the status and timelines of
regulatory submissions, the costs associated with protecting patents and other proprietary rights,
the ability to complete strategic collaborations and the availability of third-party funding, if
any.
Selling securities to satisfy our short-term and long-term capital requirements may have the
effect of materially diluting the current holders of our outstanding stock. We may also seek
additional funding through corporate collaborations and other financing vehicles. If funds are
obtained through arrangements with collaborative partners or others, we may be required to
relinquish rights to our technologies or product candidates.
If we are unable to complete the merger and related stock conversion transaction with respect to
our preferred stock, we may not be able to secure future equity financing or merge with a third
party.
In December 1997, we entered into an agreement with Genentech relating to the development of
pimagedine, an A.G.E. formation inhibitor, for the treatment of diabetic nephropathy. As part of
this agreement, Genentech purchased shares of Alteon Series G Preferred Stock and Series H
Preferred Stock, the proceeds of which were used to fund the pimagedine development program. Both
the Series G Preferred Stock and Series H Preferred Stock have dividends which are payable
quarterly in shares of preferred stock at a rate of 8.5% of the accumulated balance. The Series G
and Series H Preferred Stock each carry a liquidation preference, which means that the value
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of that preferred stock would be required to be paid to the holders of the Series G and Series H
Preferred Stock upon a sale or liquidation before any proceeds from such sale or liquidation are
paid to any other holders of equity securities, including the common stock. As of March 31, 2006,
holders of the outstanding shares of Series G and Series H Preferred Stock, including shares issued
pursuant to the dividend obligation, were entitled to a liquidation preference of $56,789,227. Our
total market capitalization as of that date was $12,759,276. As a result, unless we complete the
merger, holders of our common stock will not realize any value upon our sale or liquidation at a
valuation of less than $56,789,227. The Series G and Series H Preferred Stock have no voting
rights. Each share of Series G Preferred Stock and Series H Preferred Stock is convertible, upon 70
days prior written notice, into the number of shares of common stock determined by dividing
$10,000 by the average of the closing prices of our common stock, as reported on the American Stock
Exchange, for the 20 business days immediately preceding the date of conversion. On March 31, 2006,
the Series G and Series H Preferred Stock would have been convertible into 55,623,529 and
167,079,216 shares of common stock, respectively, representing, in aggregate, approximately 79.3%
of our common stock outstanding on an as-converted basis as of that date.
While the terms of the Series G and Series H Preferred Stock generally restrict Genentechs
ownership position in us upon conversion to 40% of our outstanding common stock, any conversion of
shares of Series G and/or Series H Preferred Stock into common stock would represent a substantial
dilution to existing common shareholders. Potential financing sources for us may be dissuaded from
investing in us in light of the presence of a significant holder of securities having a sizable
liquidation preference and/or voting position. This could also discourage any potential acquirer
from pursuing a transaction with us at a valuation that does not result in sufficient proceeds to
pay the full liquidation preference due to Genentech.
As noted above, on April 19, 2006, we entered into a definitive merger agreement with
HaptoGuard, Inc., whereby the two companies will combine operations in a stock transaction valued
at $8.8 million. As part of the merger, a portion of existing shares of Alteon preferred stock held
by Genentech, Inc. (a) will be converted into 13,492,349 shares of common stock and (b) a portion
of such stock will be converted to common stock valued at $3.5 million, or approximately 14,874,628
shares and will be transferred to HaptoGuard shareholders in exchange for certain negotiation and
royalty rights for certain HaptoGuard products, and the remaining shares of Alteon preferred stock
held by Genentech, Inc. will be cancelled. The merger and stock conversion transactions are subject
to the approval of Alteon and HaptoGuard shareholders and are expected to close in the third
quarter of 2006. There is no assurance the merger and related transactions will close.
We have received a going concern opinion from our independent registered public accounting firm,
which could negatively affect our stock price and our ability to raise capital.
J.H. Cohn LLP, our independent registered public accounting firm, has included an explanatory
paragraph in their report on our financial statements for the fiscal year ended December 31, 2005,
which expresses substantial doubt about our ability to continue as a going concern. The inclusion
of a going concern explanatory paragraph in J.H. Cohn LLPs report on our financial statements
could have a detrimental effect on our stock price and our ability to raise additional capital.
Our financial statements have been prepared on the basis of a going concern, which
contemplates the realization of assets and the satisfaction of liabilities in the normal course of
business. We have not made any adjustments to the financial statements as a result of the outcome
of the uncertainty described above.
If we are unable to form the successful collaborative relationships that our business strategy
requires, then our programs will suffer and we may not be able to develop products.
Our strategy for developing and deriving revenues from our products depends, in large part,
upon entering into arrangements with research collaborators, corporate partners and others. The
potential market, preclinical and clinical study results and safety profile of our product
candidates may not be attractive to potential corporate partners. A two-year toxicity study found
that male rats exposed to high doses of alagebrium over their natural lifetime developed
dose-related increases in liver cell alterations including hepatocarcinomas, and that the
alteration rate was slightly over the expected background rate in this gender and species of rat.
Also, our Phase 2a EMERALD study in erectile dysfunction, the IND for which has since been
withdrawn, was placed on clinical hold by the Reproductive and Urologic Division which may
adversely affect our ability to enter into research and development
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collaborations with respect to alagebrium. We face significant competition in seeking appropriate
collaborators and these collaborations are complex and time-consuming to negotiate and document. We
may not be able to negotiate collaborations on acceptable terms, or at all. If that were to occur,
we may have to curtail the development of a particular product candidate, reduce or delay our
development program or one or more of our other development programs, delay our potential
commercialization or reduce the scope of our sales or marketing activities, or increase our
expenditures and undertake development or commercialization activities at our own expense. If we
elect to increase our expenditures to fund development or commercialization activities on our own,
we may need to obtain additional capital, which may not be available to us on acceptable terms, or
at all. If we do not have sufficient funds, we will not be able to bring our product candidates to
market and generate product revenue.
If we are unable to attract and retain the key personnel on whom our success depends, our product
development, marketing and commercialization plans could suffer.
We depend heavily on the principal members of our management and scientific staff to realize
our strategic goals and operating objectives. Over the past few months, due to the reduction in our
clinical trial activities, the number of our employees has decreased from 30 as of June 30, 2005 to
7 as of March 1, 2006. On February 1, 2006, we announced the resignation of our Chief Operating
Officer, Judith S. Hedstrom. Mary Phelan has resigned from her position as our Director of Finance and Financial
Reporting effective May 31, 2006. The loss of services in the near term of any of our other principal
members of management and scientific staff could impede the achievement of our development
priorities. Furthermore, recruiting and retaining qualified scientific personnel to perform
research and development work in the future will also be critical to our success, and there is
significant competition among companies in our industry for such personnel. We have established
retention programs for our current key employees, and we may be required to provide additional
retention and severance benefits to our employees as we curtail operations or prepare to effect a
strategic transaction such as a sale or merger with another company. However, we cannot assure you
that we will be able to attract and retain personnel on acceptable terms given the competition
between pharmaceutical and healthcare companies, universities and non-profit research institutions
for experienced managers and scientists, and given the recent clinical and regulatory setbacks that
we have experienced. In addition, we rely on consultants to assist us in formulating our research
and development strategy. All of our consultants are employed by other entities and may have
commitments to or consulting or advisory contracts with those other entities that may limit their
availability to us.
Clinical studies required for our product candidates are time-consuming, and their outcome is
uncertain.
Before obtaining regulatory approvals for the commercial sale of any of our products under
development, we must demonstrate through preclinical and clinical studies that the product is safe
and effective for use in each target indication. Success in preclinical studies of a product
candidate may not be predictive of similar results in humans during clinical trials. None of our
products has been approved for commercialization in the United States or elsewhere. In December
2004, we announced that findings of a routine two-year rodent toxicity study indicated that male
Sprague Dawley rats exposed to high doses of alagebrium over their natural lifetime developed
dose-related increases in liver cell alterations and tumors, and that the liver tumor rate was
slightly over the expected background rate in this gender and species of rat. In February 2005,
based on the initial results from one of the follow-on preclinical toxicity experiments, we
voluntarily and temporarily suspended enrollment of new subjects into each of the ongoing clinical
studies pending receipt of additional preclinical data. We withdrew our IND for the EMERALD study
in February 2006 in order to focus our resources on the development of alagebrium in cardiovascular
indications.
In June 2005, our Phase 2b SPECTRA trial in systolic hypertension was discontinued after an
interim analysis found that the data did not indicate a treatment effect of alagebrium and we have
ceased development of alagebrium for this indication.
We cannot predict at this time when enrollment in any of our clinical studies, will resume, if
ever. If we are unable to resume enrollment in our clinical studies in a timely manner, or at all,
our business will be materially adversely affected.
If we do not prove in clinical trials that our product candidates are safe and effective, we
will not obtain marketing approvals from the FDA and other applicable regulatory authorities. In
particular, one or more of our product candidates may not exhibit the expected medical benefits in
humans, may cause harmful side effects, may
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not be effective in treating the targeted indication or may have other unexpected characteristics
that preclude regulatory approval for any or all indications of use or limit commercial use if
approved.
The length of time necessary to complete clinical trials varies significantly and is difficult
to predict. Factors that can cause delay or termination of our clinical trials include:
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slower than expected patient enrollment due to the nature of the protocol, the proximity
of subjects to clinical sites, the eligibility criteria for the study, competition with
clinical trials for other drug candidates or other factors; |
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adverse results in preclinical safety or toxicity studies; |
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lower than expected retention rates of subjects in a clinical trial; |
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inadequately trained or insufficient personnel at the study site to assist in overseeing
and monitoring clinical trials; |
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delays in approvals from a study sites review board, or other required approvals; |
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longer treatment time required to demonstrate effectiveness or determine the appropriate product dose; |
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lack of sufficient supplies of the product candidate; |
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adverse medical events or side effects in treated subjects; |
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lack of effectiveness of the product candidate being tested; and |
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regulatory changes. |
Even if we obtain positive results from preclinical or clinical studies for a particular
product, we may not achieve the same success in future studies of that product. Data obtained from
preclinical and clinical studies are susceptible to varying interpretations that could delay, limit
or prevent regulatory approval. In addition, we may encounter delays or rejections based upon
changes in FDA policy for drug approval during the period of product development and FDA regulatory
review of each submitted new drug application. We may encounter similar delays in foreign
countries. Moreover, regulatory approval may entail limitations on the indicated uses of the drug.
Failure to obtain requisite governmental approvals or failure to obtain approvals of the scope
requested will delay or preclude our licensees or marketing partners from marketing our products or
limit the commercial use of such products and will have a material adverse effect on our business,
financial condition and results of operations.
In addition, some or all of the clinical trials we undertake may not demonstrate sufficient
safety and efficacy to obtain the requisite regulatory approvals, which could prevent or delay the
creation of marketable products. Our product development costs will increase if we have delays in
testing or approvals, if we need to perform more, larger or different clinical or preclinical
trials than planned or if our trials are not successful. Delays in our clinical trials may harm our
financial results and the commercial prospects for our products.
Before a clinical trial may commence in the United States, we must submit an IND, containing
preclinical studies, chemistry, manufacturing, control and other information and a study protocol
to the FDA. If the FDA does not object within 30 days after submission of the IND, then the trial
may commence. If commenced, the FDA may delay, limit, suspend or terminate clinical trials at any
time, or may delay, condition or reject approval of any of our product candidates, for many
reasons. For example:
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ongoing preclinical or clinical study results may indicate that the product candidate is
not safe or effective; |
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the FDA may interpret our preclinical or clinical study results to indicate that the
product candidate is not |
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safe or effective, even if we interpret the results differently; or |
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the FDA may deem the processes and facilities that our collaborative partners, our
third-party manufacturers or we propose to use in connection with the manufacture of the
product candidate to be unacceptable. |
If we do not successfully develop any products, or are unable to derive revenues from product
sales, we will never be profitable.
Virtually all of our revenues to date have been generated from collaborative research
agreements and investment income. We have not received any revenues from product sales. We may not
realize product revenues on a timely basis, if at all, and there can be no assurance that we will
ever be profitable.
At March 31, 2006, we had an accumulated deficit of $225,610,000. We anticipate that we will
incur substantial, potentially greater, losses in the future as we continue our research,
development and clinical studies. We have not yet requested or received regulatory approval for any
product from the FDA or any other regulatory body. All of our product candidates, including our
lead candidate, alagebrium, are still in research, preclinical or clinical development. We may not
succeed in the development and marketing of any therapeutic or diagnostic product. We do not have
any product other than alagebrium in clinical development, and there can be no assurance that we
will be able to bring any other compound into clinical development. Adverse results of any
preclinical or clinical study could cause us to materially modify our clinical development
programs, resulting in delays and increased expenditures, or cease development for all or part of
our ongoing studies of alagebrium.
In February 2006, the EMERALD study of alagebrium in ED was discontinued in order to focus our
resources on development of alagebrium for cardiovascular indications.
In June 2005, our SPECTRA Phase 2b trial in systolic hypertension, was discontinued after an
interim analysis found that the data did not indicate a treatment effect of alagebrium and we have
ceased development of alagebrium for this indication.
To achieve profitable operations, we must, alone or with others, successfully identify,
develop, introduce and market proprietary products. Such products will require significant
additional investment, development and preclinical and clinical testing prior to potential
regulatory approval and commercialization. The development of new pharmaceutical products is highly
uncertain and expensive and subject to a number of significant risks. Potential products that
appear to be promising at early stages of development may not reach the market for a number of
reasons. Potential products may be found ineffective or cause harmful side effects during
preclinical testing or clinical studies, fail to receive necessary regulatory approvals, be
difficult to manufacture on a large scale, be uneconomical, fail to achieve market acceptance or be
precluded from commercialization by proprietary rights of third parties. We may not be able to
undertake additional clinical studies. In addition, our product development efforts may not be
successfully completed, we may not have the funds to complete any ongoing clinical trials, we may
not obtain regulatory approvals, and our products, if introduced, may not be successfully marketed
or achieve customer acceptance. We do not expect any of our products, including alagebrium, to be
commercially available for a number of years, if at all.
Failure to remediate the material weaknesses in our internal controls and to achieve and maintain
effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 could
have a material adverse effect on our business and stock price.
During the audit of our financial statements for the year ended December 31, 2005, our
independent registered public accounting firm identified a material weakness, as of December 31,
2005, regarding our internal controls over the identification of and the accounting for non-routine
transactions including certain costs related to potential strategic transactions, severance
benefits and the financial statement recording and disclosures of stock options that we have
granted to non-employee consultants in accordance with Emerging Issues Task Force (EITF) Issue
No. 96-18. As defined by the Public Company Accounting Oversight Board Auditing Standard No. 2, a
material weakness is a significant control deficiency or a combination of significant control
deficiencies, that results
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in there being more than a remote likelihood that a material misstatement of the annual or interim
financial statements will not be prevented or detected. This material weakness did not result in
the restatement of any previously reported financial statements or any other related financial
disclosure. Management is in the process of implementing remedial controls to address these
matters. In addition, the changes that would have resulted in the financial statements for the year
ended December 31, 2005, as a consequence of the material weakness, were deemed by the Company to
be immaterial but were nevertheless recorded by the Company.
On April 22, 2005, we filed an amendment to our Annual Report on Form 10-K for the fiscal year
ended December 31, 2004 (the 10-K Amendment), in which we reported that, as of December 31, 2004,
and as required by Section 404 of the Sarbanes-Oxley Act of 2002, management, with the
participation of our principal executive officer and principal financial officer, had assessed the
effectiveness of our internal control over financial reporting based on the framework established
in Internal Control Integrated Framework issued by the Committee of Sponsoring Organizations of
the Treadway Commission (COSO). Managements assessment included an evaluation of the design of
our internal control over financial reporting and testing of the operational effectiveness of our
internal control over financial reporting. Management reviewed the results of its assessment with
the Audit Committee of our Board of Directors, and based on this assessment, management determined
that as of December 31, 2004, there were three material weaknesses in our internal control over
financial reporting. In light of these material weaknesses, management concluded that, as of
December 31, 2004, we did not maintain effective internal control over financial reporting.
The three material weaknesses identified were in the areas of audit committee oversight of the
internal control review process, information technology controls and process controls, and control
over cash disbursements. With respect to each of these matters, as set forth in the Form 10-K
Amendment, management has implemented remedial measures or procedures to address these matters.
However, we cannot currently assure that the remedial measures that are currently being implemented
will be sufficient to result in a conclusion that our internal controls no longer contain any
material weaknesses, and that our internal controls are effective. In addition, we cannot assure
you that, even if we are able to achieve effective internal control over financial reporting, our
internal controls will remain effective for any period of time.
If we are able to form collaborative relationships, but are unable to maintain them, our product
development may be delayed and disputes over rights to technology may result.
We may form collaborative relationships that, in some cases, will make us dependent upon
outside partners to conduct preclinical testing and clinical studies and to provide adequate
funding for our development programs.
In general, collaborations involving our product candidates pose the following risks to us:
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collaborators may fail to adequately perform the scientific and preclinical studies
called for under our agreements with them; |
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collaborators have significant discretion in determining the efforts and resources that
they will apply to these collaborations; |
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collaborators may not pursue further development and commercialization of our product
candidates or may elect not to continue or renew research and development programs based on
preclinical or clinical study results, changes in their strategic focus or available
funding or external factors, such as an acquisition that diverts resources or creates
competing priorities; |
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collaborators may delay clinical trials, provide insufficient funding for a clinical
program, stop a clinical study or abandon a product candidate, repeat or conduct new
clinical trials or require a new formulation of a product candidate for clinical testing; |
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collaborators could independently develop, or develop with third parties, products that
compete directly or indirectly with our products or product candidates if the collaborators
believe that competitive products are more likely to be successfully developed or can be
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9
25, Accounting for Stock Issued to Employees, and related interpretations, under which no
compensation cost (excluding those options granted below fair market value) had been recognized.
SFAS 123 established accounting and disclosure requirements using a fair-value based method of
accounting for stock-based employee compensation plans. As permitted by SFAS 123, the Company
elected to continue to apply the intrinsic-value based method of accounting described above, and
adopted only the disclosure requirements of SFAS 123, as amended.
If we are not able to compete successfully with other companies in the development and marketing of
cures and therapies for cardiovascular diseases, diabetes, and the other conditions for which we
seek to develop products, we may not be able to continue our operations.
We are engaged in pharmaceutical fields characterized by extensive research efforts and rapid
technological progress. Many established pharmaceutical and biotechnology companies with financial,
technical and human resources greater than ours are attempting to develop, or have developed,
products that would be competitive with our products. Many of these companies have extensive
experience in preclinical and human clinical studies. Other companies may succeed in developing
products that are safer, more efficacious or less costly than any we may develop and may also be
more successful than us in production and marketing. Rapid technological development by others may
result in our products becoming obsolete before we recover a significant portion of the research,
development or commercialization expenses incurred with respect to those products.
Certain technologies under development by other pharmaceutical companies could result in
better treatments for cardiovascular disease, and diabetes and its related complications. Several
large companies have initiated or expanded research, development and licensing efforts to build
pharmaceutical franchises focusing on these medical conditions, and some companies already have
products approved and available for commercial sale to treat these indications. It is possible that
one or more of these initiatives may reduce or eliminate the market for some of our products. In
addition, other companies have initiated research in the inhibition or crosslink breaking of
A.G.E.s.
If governments and third-party payers continue their efforts to contain or decrease the costs of
healthcare, we may not be able to commercialize our products successfully.
In certain foreign markets, pricing and/or profitability of prescription pharmaceuticals are
subject to government control. In the United States, we expect that there will continue to be
federal and state initiatives to control and/or reduce pharmaceutical expenditures. In addition,
increasing emphasis on managed care in the United States will continue to put pressure on
pharmaceutical pricing. Cost control initiatives could decrease the price that we receive for any
products for which we may receive regulatory approval to develop and sell in the future and could
have a material adverse effect on our business, financial condition and results of operations.
Further, to the extent that cost control initiatives have a material adverse effect on our
corporate partners, our ability to commercialize our products may be adversely affected. Our
ability to commercialize pharmaceutical products may depend, in part, on the extent to which
reimbursement for the products will be available from government health administration authorities,
private health insurers and other third-party payers. Significant uncertainty exists as to the
reimbursement status of newly approved healthcare products, and third-party payers, including
Medicare, frequently challenge the prices charged for medical products and services. In addition,
third-party insurance coverage may not be available to subjects for any products developed by us.
Government and other third-party payers are attempting to contain healthcare costs by limiting both
coverage and the level of reimbursement for new therapeutic products and by refusing in some cases
to provide coverage for uses of approved products for disease indications for which the FDA has not
granted labeling approval. If government and other third-party payers for our products do not
provide adequate coverage and reimbursement levels, the market acceptance of these products would
be adversely affected.
If the users of the products that we are developing claim that our products have harmed them, we
may be subject to costly and damaging product liability litigation, which could have a material
adverse effect on our business, financial condition and results of operations.
The use of any of our potential products in clinical studies and the sale of any approved
products, including the testing and commercialization of alagebrium or other compounds, may expose
us to liability claims resulting from the use of products or product candidates. Claims could be
made directly by participants in our clinical studies, consumers, pharmaceutical companies or
others. We maintain product liability insurance coverage for claims arising
13
from the use of our products in clinical studies. However, coverage is becoming increasingly
expensive, and we may not be able to maintain or acquire insurance at a reasonable cost or in
sufficient amounts to protect us against losses due to liability that could have a material adverse
effect on our business, financial condition and results of operations. We may not be able to obtain
commercially reasonable product liability insurance for any product approved for marketing in the
future, and insurance coverage and our resources may not be sufficient to satisfy any liability
resulting from product liability claims. A successful product liability claim or series of claims
brought against us could have a material adverse effect on our business, financial condition and
results of operations.
Risks Relating to the Merger
Alteons ability to continue as a going concern is dependent on future financing.
J.H. Cohn LLP, our independent registered public accounting firm, has included an explanatory
paragraph in its report on our financial statements for the fiscal year ended December 31, 2005,
which expresses substantial doubt about our ability to continue as a going concern. The inclusion
of a going concern explanatory paragraph in J.H. Cohn LLPs report on our financial statements
could have a detrimental effect on our stock price and our ability to raise additional capital,
either alone or as a combined company.
Our financial statements have been prepared on the basis of a going concern, which
contemplates the realization of assets and the satisfaction of liabilities in the normal course of
business. We have not made any adjustments to the financial statements as a result of the outcome
of the uncertainty described above. Accordingly, the value of the combined company in liquidation may be
different from the values set forth in our financial statements.
If
the merger is not completed, the liquidation preference associated with the
shares of Alteon preferred stock owned by Genentech and the
substantial common stock ownership represented by these preferred
shares, on an as-converted basis, will make it
unlikely that the combined company will be able to obtain additional funding. The continued success of the
combined company will depend on its ability to continue to raise capital in order to fund the
development and commercialization of its products.
Failure to raise additional capital may result
in substantial adverse circumstances, including delisting of our common stock shares from the
American Stock Exchange, which could substantially decrease the liquidity and value of such shares,
or ultimately result in the liquidation of the combined company.
Alteon and HaptoGuard have each historically incurred operating losses and these losses will
continue after the merger.
Alteon and HaptoGuard have each historically incurred substantial operating losses due to
their research and development activities and expect these losses to continue after the merger for
the foreseeable future. As of December 31, 2005, Alteon and HaptoGuard had an accumulated deficit
of approximately $222,813,445 and $2,425,258, respectively. Alteons fiscal year 2005, 2004 and
2003 net losses were $12,614,459, $13,958,646, and $14,452,418, respectively. HaptoGuards fiscal
year 2005 and 2004 net losses were $1,654,695 and $770,563, respectively. Alteons fiscal year
2005, 2004 and 2003 net losses applicable to common stockholders were $17,100,795, $18,093,791 and
$18,243,265, respectively. The combined company currently expects to continue its research and
development activities at the same or at a more rapid pace than prior periods. After the merger,
the combined company will expend significant amounts on research and development programs for
alagebrium and ALT-2074. These activities will take time and expense, both to identify appropriate
partners, to reach agreement on basic terms, and to negotiate and sign definitive agreements. We
will actively seek new financing from time to time to provide financial support for our research
and development activities. Any partnering agreements would required significant time and effort
to identify potential partners, to reach agreement on basic terms and to negotiate and sign
definitive agreements.
The combined company will need additional capital in the future, but its access to such capital is
uncertain.
At this time we are not able to assess the probability of success in our fundraising efforts
or the terms, if any, under which we may secure financial support from strategic partners or other
investors. It is expected that we will continue to incur operating losses for the foreseeable
future. Alteons current resources are insufficient to fund its own commercialization efforts as
well as the combined companys commercialization efforts. As of March 31, 2006, Alteon had cash on
hand of $4,469,170. As described elsewhere in this prospectus, in April, 2006 we closed
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on approximately $2.6 million in financing. Prior to the financing, Alteon was expending
approximately $450,000 in cash per month. Following the merger, including HaptoGuards cash
spending rate of approximately $110,000 in cash per month, the combined company expects to spend
approximately $560,000 in cash per month. Our capital needs beyond the second quarter of 2006 will
depend on many factors, including our research and development activities and the success thereof,
the scope of our clinical trial program, the timing of regulatory approval for our products under
development and the successful commercialization of our products. Our needs may also depend on the
magnitude and scope of these activities, the progress and the level of success in our clinical
trials, the costs of preparing, filing, prosecuting, maintaining and enforcing patent claims and
other intellectual property rights, competing technological and market developments, changes in or
terminations of existing collaboration and licensing arrangements, the establishment of new
collaboration and licensing arrangements and the cost of manufacturing scale-up and development of
marketing activities, if undertaken by the combined company. Other than the recently completed
financing described in this prospectus, we do not have committed external sources of funding and
may not be able to secure additional funding on any terms or on terms that are favourable to us.
If we raise additional funds by issuing additional stock, further dilution to our existing
stockholders will result, and new investors may negotiate for rights superior to existing
stockholders. If adequate funds are not available, the combined company may be required to:
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delay, reduce the scope of or eliminate one or more of its development programs; |
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obtain funds through arrangements with collaboration partners or others that may require
it to relinquish rights to some or all of its technologies, product candidates or products
that it would otherwise seek to develop or commercialize itself; |
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license rights to technologies, product candidates or products on terms that are less
favorable to it than might otherwise be available; or |
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seek a buyer for all or a portion of its business, or wind down its operations and
liquidate its assets on terms not favorable to it. |
The success of the combined company will also depend on the products and systems under development
by HaptoGuard, including ALT-2074, and we cannot assure you that the efforts to commercialize
ALT-2074 will succeed.
ALT-2074, HaptoGuards lead compound, is in development for the treatment of heart
complications in patients with diabetes. It has demonstrated efficacy in mouse models.
ALT-2074 is still in early clinical trials and any success to date should not be seen as
indicative of the probability of any future success. The failure to complete clinical development
and commercialize ALT-2074 for any reason or due to a combination of reasons will have a material
adverse impact on the combined company.
We are dependent on the successful outcome of clinical trials and will not be able to
successfully develop and commercialize products if clinical trials are not successful.
HaptoGuard received approval from Israels Ministry of Health to conduct
Phase 2 trials in diabetic patients recovering from a recent
myocardial infarction or acute coronary syndrome. The purpose of the
study is to evaluate the biological effects on cardiac tissue in
patients treated with ALT-2074. HaptoGuard
has received Institutional Review Board approval for 3 sites in
Israel. HaptoGuard recently withdrew its submission to request
approval to conduct Phase 2 clinical trials in the
Czech Republic in order to have the time to generate a response to
the Czech Republics request for additional data on drug
stability. The failure of either Alteon or HaptoGuard to obtain approvals to conduct clinical trials would
adversely affect the combined companys business.
None of Alteons or HaptoGuards product candidates are currently approved for sale by the FDA
or by any other regulatory agency in the world, and may never receive approval for sale or become
commercially viable. Before obtaining regulatory approval for sale, each of the combined companys
product candidates will be subjected to extensive preclinical and clinical testing to demonstrate
safety and efficacy for a particular indication for humans
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in addition to meeting other regulatory standards. The combined companys success will depend on
the successful outcome of clinical trials for one or more product candidates.
There are a number of difficulties and risks associated with clinical trials. The possibility
exists that:
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we may discover that a product candidate may cause, alone or in combination with
another therapy, harmful side effects; |
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we may discover that a product candidate, alone or in combination with another therapy,
does not exhibit the expected therapeutic results in humans; |
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results from early trials may not be statistically significant or predictive of results
that may be obtained from large-scale, advanced clinical trials; |
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we, the FDA, other similar foreign regulatory agencies or an institutional review board
may suspend clinical trials for any reason whatsoever; |
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patient recruitment may be slower than expected; |
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patients may drop out of our clinical trials; and |
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we may be unable to produce sufficient supplies of products in a timely fashion for clinical trials. |
Given the uncertainty surrounding the regulatory and clinical trial process, we may not be
able to develop safety, efficacy or manufacturing data necessary for approval for any product
candidate. In addition, even if we receive approval, such approval may be limited in scope and hurt
the commercial viability of such product. If the combined company is unable to successfully obtain
approval of and commercialize a product, this would materially harm the business, impair our
ability to generate revenues and adversely impact our stock price.
The combined company is subject to significant government regulation and failure to achieve
regulatory approval of our drug candidates would harm our business.
The FDA regulates the development, testing, manufacture, distribution, labeling and promotion
of pharmaceutical products in the United States pursuant to the Federal Food, Drug, and Cosmetic
Act and related regulations. We must receive pre-market approval by the FDA prior to any commercial
sale of any drug candidates. Before receiving such approval, we must provide preclinical data and
proof in human clinical trials of the safety and efficacy of our drug candidates, which trials can
take several years. In addition, we must show that we can produce any drug candidates consistently
at quality levels sufficient for administration in humans. Pre-market approval is a lengthy and
expensive process. We may not be able to obtain FDA approval for any commercial sale of any drug
candidate. By statute and regulation, the FDA has 180 days to review an application for approval to
market a drug candidate; however, the FDA frequently exceeds the 180-day time period, at times
taking up to 18 months. In addition, based on its review, the FDA or other regulatory bodies may
determine that additional clinical trials or preclinical data are required. Except for any
potential licensing or marketing arrangements with other pharmaceutical or biotechnology companies,
we will not generate any revenues in connection with any of our other drug candidates unless and
until we obtain FDA approval to sell such products in commercial quantities for human application.
Even if the combined companys products receive approval for commercial sale, their
manufacture, storage, marketing and distribution are and will be subject to extensive and
continuing regulation in the United States by the federal government, especially the FDA, and state
and local governments. The failure to comply with these regulatory requirements could result in
enforcement action, including, without limitation, withdrawal of approval, which would have a
material adverse effect on the combined companys business. Later discovery of problems with the
combined companys products may result in additional restrictions on the product, including
withdrawal of the product from the market. Regulatory authorities may also require post-marketing
testing, which can involve significant uncontemplated expense. Additionally, governments may impose
new regulations, which
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could further delay or preclude regulatory approval of the combined companys products or result in
significantly increased compliance costs.
In similar fashion to the FDA, foreign regulatory authorities require demonstration of product
quality, safety and efficacy prior to granting authorization for product registration which allows
for distribution of the product for commercial sale. International organizations, such as the World
Health Organization, and foreign government agencies including those for the Americas, Middle East,
Europe, and Asia and the Pacific, have laws, regulations and guidelines for reporting and
evaluating the data on safety, quality and efficacy of new drug products. Although most of these
laws, regulations and guidelines are very similar, each of the individual nations reviews all of
the information available on the new drug product and makes an independent determination for
product registration. A finding of product quality, safety or efficacy in one jurisdiction does
not guarantee approval in any other jurisdiction, even if the other jurisdiction has similar laws,
regulations and guidelines.
Failure to integrate the companies operations successfully could result in delays and increased
expenses in the companies clinical trial programs.
Alteon and HaptoGuard have entered into the merger agreement with the expectation that the
merger will result in beneficial synergies, including:
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improved ability to raise new capital through access to new classes of investors focused
on public companies engaged in small molecule drug development; |
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shared expertise in developing innovative small molecule drug technologies and the
potential for technology collaboration; |
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a broader pipeline of products; |
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greater ability to attract commercial partners; |
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larger combined commercial opportunities; and |
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a broader portfolio of patents and trademarks. |
Achieving these anticipated synergies and the potential benefits underlying the two companies
reasons for the merger will depend on a number of factors, some of which include:
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retention of scientific staff; |
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significant litigation, if any, adverse to Alteon and HaptoGuard, including,
particularly, product liability litigation and patent and trademark litigation; and |
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the ability of the combined company to continue development of Alteon and HaptoGuard
product candidates; |
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success of our research and development efforts; |
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increased capital expenditures; |
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general market conditions relating to small cap biotech investments; and |
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competition from other drug development companies. |
Achieving the benefits of the merger will depend in part on the successful integration of
Alteon and HaptoGuard in a timely and efficient manner. The integration will require significant
time and efforts from each
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company, including the coordination of research, development, regulatory, manufacturing,
commercial, administrative and general functions. Integration may be difficult and unpredictable
because of possible cultural conflicts and different opinions on scientific and regulatory matters.
Delays in successfully integrating and managing employee benefits could lead to dissatisfaction
and employee turnover. The combination of Alteons and HaptoGuards organizations may result in
greater competition for resources and elimination of research and development programs that might
otherwise be successfully completed. If we cannot successfully integrate our operations and
personnel, we may not recognize the expected benefits of the merger.
Even if the two companies are able to integrate their operations, there can be no assurance
that these anticipated synergies will be achieved. The failure to achieve such synergies could
have a material adverse effect on the business, results of operations and financial condition of
the combined company.
Integrating Alteon and HaptoGuard may divert managements attention away from our core research and
development activities.
Successful integration of our operations, products and personnel may place a significant
burden on our management and our internal resources. The diversion of managements attention and
any difficulties encountered in the transition and integration process could result in delays in
the companies clinical trial programs and could otherwise significantly harm our business,
financial condition and operating results.
We expect to incur significant costs integrating our operations, product candidates and
personnel, which cannot be estimated accurately at this time. These costs include:
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severance; |
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conversion of information systems; |
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combining research, development, regulatory, manufacturing and commercial teams and processes; |
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reorganization of facilities; and |
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relocation or disposition of excess equipment. |
We expect that Alteon and HaptoGuard will incur aggregate direct transaction costs of
approximately $800,000 associated with the merger. If the total costs of the merger exceed our
estimates or benefits of the merger do not exceed the total costs of the merger, the financial
results of our combined company could be adversely affected.
Completion of, or the failure to complete, the merger could adversely affect Alteons stock price
and Alteons and HaptoGuards future business and operations.
The merger is subject to the satisfaction of various closing conditions, including the
approval by both Alteon and HaptoGuard stockholders, and there can be no assurance that the merger
will be successfully completed. In the event that the merger is not consummated, Alteon and
HaptoGuard will be subject to many risks, including the costs related to the merger, such as legal,
accounting and advisory fees, which must be paid even if the merger is not completed, or the
payment of a termination fee under certain circumstances. If the merger is not consummated for any
reason, the market price of Alteon common stock could decline.
The shares of the combined company are publicly traded and we cannot predict how the market
will react to the merger of Alteon and HaptoGuard. Even the successful completion of the merger
may negatively affect the stock price of the combined company, if the market were to come to the
view that Alteon would be in a better position absent completion of the merger.
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The combined company will remain dependent on third parties for research and development and
manufacturing activities necessary to commercialize certain of our patents.
We utilize the services of several scientific and technical consultants to oversee
various aspects of our protocol design, clinical trial oversight and other research and development
functions. Alteon and HaptoGuard both contract out most of our research and development
operations, utilize third-party contract manufacturers for drug inventory and shipping services and
third-party contract research organizations in connection with preclinical and/or clinical studies
in accordance with our designed protocols, as well as conducting research at medical and academic
centers.
Because we rely on third parties for much our research and development work and manufacturing,
we have less direct control over our research and development and manufacturing. We face risks
that these third parties may not be appropriately responsive to our time frames and development
needs and could devote resources to other customers. In addition, certain of these third parties
may have to comply with FDA regulations or other regulatory requirements in the conduct of this
research and development work, which they may fail to do.
If the combined company does not successfully distinguish and commercialize its technology, it may
be unable to compete successfully or to generate significant revenues.
The biotechnology industry, including the field of small molecule drugs to treat and prevent
cardiovascular disease and diabetes, is highly competitive and subject to significant and rapid
technological change. Accordingly, the combined companys success will depend, in part, on its
ability to respond quickly to such change through the development and introduction of new products
and systems.
The combined company will have substantial competition, including competitors with substantially
greater resources.
Many of the combined companys competitors or potential competitors have substantially greater
financial and other resources than Alteon has and may also have greater experience in conducting
pre-clinical studies, clinical trials and other regulatory approval procedures as well as in
marketing their products. Major competitors in the market for our potential products include large,
publicly-traded pharmaceutical companies, public development stage companies and private
development stage companies. If the combined company or its corporate partners commence commercial
product sales, the combined company or its corporate partners will be competing against companies
with greater marketing and manufacturing capabilities.
The combined companys ability to compete successfully against currently existing and future
alternatives to its product candidates and systems, and competitors who compete directly with it in
the small molecule drug industry will depend, in part, on its ability to:
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attract and retain skilled scientific and research personnel; |
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develop technologically superior products; |
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develop competitively priced products; |
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obtain patent or other required regulatory approvals for the combined companys products; |
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be early entrants to the market; and |
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manufacture, market and sell its products, independently or through collaborations. |
The success of the combined company is dependent on the extent of third-party reimbursement for its
products.
Third-party reimbursement policies may also adversely affect the combined companys ability to
commercialize and sell its products. The combined companys ability to successfully commercialize
its products depends in part on the extent to which appropriate levels of reimbursement for its
products and related treatments are obtained from government authorities, private health insurers,
third party payers, and other organizations, such
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as managed care organizations, or MCOs. Any failure by doctors, hospitals and other users of the
combined companys products or systems to obtain appropriate levels of reimbursement could
adversely affect the combined companys ability to sell these products and systems.
Federal legislation, enacted in December 2003, has altered the way in which
physician-administered drug programs covered by Medicare are reimbursed, generally leading to lower
reimbursement levels. The new legislation has also added an outpatient prescription drug benefit to
Medicare, effective January 2006. In the interim, the U.S. Congress has established a discount drug
card program for Medicare beneficiaries. Both benefits will be provided through private entities,
which will attempt to negotiate price concessions from pharmaceutical manufacturers. These
negotiations may increase pressures to lower prices. On the other hand, the drug benefit may
increase the volume of pharmaceutical drug purchases, offsetting at least in part these potential
price discounts. While the new law specifically prohibits the U.S. government from interfering in
price negotiations between manufacturers and Medicare drug plan sponsors, some members of Congress
are pursuing legislation that would permit de facto price controls on prescription drugs. In
addition, the law triggers, for congressional consideration, cost containment measures for Medicare
in the event Medicare cost increases exceed a certain level. These cost containment measures could
include limitations on prescription drug prices. This legislation could adversely impact the
combined companys ability to commercialize any of its products successfully.
Significant uncertainty exists about the reimbursement status of newly approved medical
products and services. Reimbursement in the United States or foreign countries may not be available
for any of the combined companys products, reimbursement granted may not be maintained, and limits
on reimbursement available from third-party payers may reduce the demand for, or negatively affect
the price of, the combined companys products. Alteon anticipates that the combined company will
need to work with a variety of organizations to lobby government agencies for improved
reimbursement policies for its products. However, Alteon cannot guarantee that such lobbying
efforts will take place or that they will ultimately be successful.
Internationally, where national healthcare systems are prevalent, little if any funding may be
available for new products, and cost containment and cost reduction efforts can be more pronounced
than in the United States.
If the combined company is unable to protect its intellectual property, it may not be able to
operate its business profitably.
The combined companys success will depend on its ability to develop proprietary products and
technologies, to obtain and maintain patents, to protect trade secrets, and to prevent others from
infringing on its proprietary rights. The combined company has exclusive patents, licenses to
patents or patent applications covering critical components of its technologies, including certain
jointly owned patents. We also seek to protect our proprietary technology and processes, in part,
by confidentiality agreements with our employees and certain contractors. Patents, pending patent
applications and licensed technologies may not afford adequate protection against competitors, and
any pending patent applications now or hereafter filed by or licensed to us may not result in
patents being issued. In addition, certain of the combined companys technology relies on patented
inventions developed using university resources. Universities may have certain rights, as defined
by law or applicable agreements, in such patents, and may choose to exercise such rights. To the
extent that employees, consultants or contractors of the combined company use intellectual property
owned by others, disputes may arise as to the rights related to or resulting from the know-how and
inventions. In addition, the laws of certain non-U.S. countries do not protect intellectual
property rights to the same extent as do the laws of the United States. Medical technology patents
involve complex legal and factual questions and, therefore, the combined company cannot predict
with certainty their enforceability.
The combined company is a party to various license agreements that give it exclusive and
partial exclusive rights to use specified technologies applicable to research, development and
commercialization of its products, including alagebrium and ALT-2074. The agreements pursuant to
which such technology is used permit the licensors to terminate agreements in the event that
certain conditions are not met. If these conditions are not met and the agreements are terminated,
the combined companys product development, research and commercialization efforts may be altered
or delayed.
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Patents or patent applications, if issued, may be challenged, invalidated or circumvented, or
may not provide protection or competitive advantages against competitors with similar technology.
Furthermore, competitors of the combined company may obtain patent protection or other intellectual
property rights for technology similar to the combined companys that could limit its ability to
use its technology or commercialize products that it may develop.
Litigation may be necessary to assert claims of infringement, to enforce patents issued to the
combined company, to protect trade secrets or know-how or to determine the scope and validity of
the proprietary rights of others. Litigation or interference proceedings could result in
substantial additional costs and diversion of management focus. If the combined company is
ultimately unable to protect its technology, trade secrets or know-how, it may be unable to operate
profitably. Although we have not been involved with any threats of litigation or negotiations
regarding patent issues or other intellectual property, or other related court challenges or legal
actions, it is possible that the combined company could be involved with such matters in the
future.
If the combined company is unable to operate its business without infringing upon intellectual
property rights of others, it may not be able to operate its business profitably.
The combined companys success depends on its ability to operate without infringing upon the
proprietary rights of others. We are aware that patents have been applied for and/or issued to
third parties claiming technologies for Advanced Glycation End-Products or glutathione peroxidase
mimetics that may be similar to those needed by us. To the extent that planned or potential
products are covered by patents or other intellectual property rights held by third parties, the
combined company would need a license under such patents or other intellectual property rights to
continue development and marketing of its products. Any required licenses may not be available on
acceptable terms, if at all. If the combined company does not obtain such licenses or it may not be
able to proceed with the development, manufacture or sale of its products.
Litigation may be necessary to defend against claims of infringement or to determine the scope
and validity of the proprietary rights of others. Litigation or interference proceedings could
result in substantial additional costs and diversion of management focus. If the combined company
is ultimately unsuccessful in defending against claims of infringement, it may be unable to operate
profitably.
HaptoGuards ALT-2074 and other HaptoGuard compounds are licensed to HaptoGuard by third parties
and if the combined company is unable to continue licensing this technology our future prospects
may be materially adversely affected.
HaptoGuard licenses technology,
including technology related to ALT-2074, from third parties.
We anticipate that we will continue to license technology from third parties in the future. To
maintain HaptoGuards license to ALT-2074 from Oxis International, we are obligated to meet certain
development and clinical trial milestones and to make certain payments. There can be no assurance
that we will be able to meet any milestone or make any payment required under the license with Oxis
International. While Oxis has not claimed a default under the license
agreement, it has indicated that its view as to whether HaptoGuard
satisfied the milestone to begin Phase 2 clinical trials by May 28,
2006 differs from HaptoGuards view. If we fail to meet any milestone or make
any payment, Oxis may terminate the license, and there can be no
assurance that we may be able to negotiate any continuation or
extension of the license agreement.
The technology HaptoGuard licenses from third parties would be difficult or impossible to
replace and the loss of this technology would materially adversely affect our business, financial
condition and any future prospects.
If the combined company loses or is unable to hire and retain qualified personnel, it may not be
able to develop its products and technology.
The combined company is highly dependent on the members of its scientific and management
staff. In particular, the combined company will depend on Dr. Noah Berkowitz as the combined companys
Chief Executive Officer and Malcolm MacNab as the combined companys Vice-President of Clinical
Development. We may not be able to attract and retain scientific and management personnel on
acceptable terms, if at all, given the competition for such personnel among other companies and
research and academic institutions. Mary Phelan has resigned from her
position as our Director of Finance and Financial Reporting effective
May 31, 2006. If the combined company loses an executive officer or certain
key members of its clinical or research and development staff or is unable to hire and retain
qualified management personnel, then its ability to develop and commercialize its products and
technology
21
and to raise capital and effect strategic opportunities may be hindered. We have not purchased and
do not anticipate purchasing any key-man life insurance.
The combined company may face exposure to product liability claims.
The combined company may face exposure to product liability and other claims due to
allegations that its products cause harm. These risks are inherent in the clinical trials for
pharmaceutical products and in the testing, and future manufacturing and marketing of, the combined
companys products. Although we currently maintain product liability insurance, such insurance may
not be adequate and the combined company may not be able to obtain adequate insurance coverage in
the future at a reasonable cost, if at all. If the combined company is unable to obtain product
liability insurance in the future at an acceptable cost or to otherwise protect against potential
product liability claims, it could be inhibited in the commercialization of its products which
could have a material adverse effect on its business. We currently have a policy covering $10
million of product liability for our clinical trials. We do not have sales of any products. The
coverage will be maintained and limits reviewed from time to time as the combined company
progresses to later stages of its clinical trials and as the length of the trials and the number of
patients enrolled in the trials changes. The combined company intends to obtain a combined coverage
policy that includes tail coverage in order to cover any claims that are made for any events that
have occurred prior to the merger. Currently, our annual premium for product liability insurance is
approximately $219,000.
Risks Related to Owning Alteons Common Stock
Our stock price is volatile and you may not be able to resell your shares at a profit.
We first publicly issued common stock on November 8, 1991 at $15.00 per share in our initial
public offering and it has been subject to fluctuations. For example, during 2005, the closing sale
price of our common stock has ranged from a high of $1.43 per share to a low of $0.17 per share.
The market price of our common stock could continue to fluctuate substantially due to a variety of
factors, including:
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quarterly fluctuations in results of operations; |
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the announcement of new products or services by the combined company or competitors; |
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sales of common stock by existing stockholders or the perception that these sales may occur; |
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adverse judgments or settlements obligating the combined company to pay damages; |
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negative publicity; |
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loss of key personnel; |
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developments concerning proprietary rights, including patents and litigation matters; and |
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clinical trial or regulatory developments in both the United States and foreign countries. |
In addition, overall stock market volatility has often significantly affected the market
prices of securities for reasons unrelated to a companys operating performance. In the past,
securities class action litigation has been commenced against companies that have experienced
periods of volatility in the price of their stock. Securities litigation initiated against the
combined company could cause it to incur substantial costs and could lead to the diversion of
managements attention and resources, which could have a material adverse effect on revenue and
earnings.
We have a large number of authorized but unissued shares of common stock, which our Board of
Directors may issue without further stockholder approval, thereby causing dilution of your holdings
of our common stock.
After the closing of the merger and the financing, there are expected to be approximately
180,000,000
22
shares of authorized but unissued shares of our common stock. Our management will continue to have
broad discretion to issue shares of our common stock in a range of transactions, including
capital-raising transactions, mergers, acquisitions, for anti-takeover purposes, and in other
transactions, without obtaining stockholder approval, unless stockholder approval is required for a
particular transaction under the rules of the American Stock Exchange, Delaware law, or other
applicable laws. We currently have no specific plans to issue shares of our common stock for any
purpose other than in connection with the merger. However, if our management determines to issue
shares of our common stock from the large pool of such authorized but unissued shares for any
purpose in the future without obtaining stockholder approval, your ownership position would be
diluted without your further ability to vote on that transaction.
The sale of a substantial number of shares of our common stock could cause the market price of our
common stock to decline and may impair the combined companys ability to raise capital through
additional offerings.
We currently have outstanding warrants to purchase an aggregate of 12,591,455 shares of our
common stock, including warrants to purchase 10,960,400
shares of our common stock issued together with 10,960,400 shares of common stock all of which such warrants and common stock we issued in connection with a private equity financing completed
in April 2006. Under the terms of the financing we have agreed to register all of such shares for
resale. The resale of these shares of common stock and the shares underlying the warrants may be
effected at any time once the registration statement of which this Prospectus is a part is
effective. The shares issued in the private equity financing, together with the shares underlying
the warrants issued in such financing, represent approximately 37.8% of the total number of shares
of our common stock outstanding immediately prior to the financing, and not including shares to be
issued in the merger with HaptoGuard or shares to be issued upon conversion of preferred stock upon
transfer to HaptoGuard.
Sales of these shares in the public market, or the perception that future sales of these
shares could occur, could have the effect of lowering the market price of our common stock below
current levels and make it more difficult for us and our shareholders to sell our equity securities
in the future.
Our executive officers, directors and holders of more than 5% of our common stock and
collectively beneficially own approximately 13.7% of the outstanding common stock as of March 31,
2006. In addition, 6,403,464 shares of common stock issuable upon exercise of vested stock options
could become available for immediate resale if such options were exercised.
Sale or the availability for sale, of shares of common stock by stockholders could cause the
market price of our common stock to decline and could impair our ability to raise capital through
an offering of additional equity securities.
Anti-takeover provisions may frustrate attempts to replace our current management and discourage
investors from buying our common stock.
We have entered into a Stockholders Rights Agreement pursuant to which each holder of a share
of common stock is granted a Right to purchase our Series F Preferred Stock under certain
circumstances if a person or group acquires, or commences a tender offer for, 20 percent of our
outstanding common stock. We also have severance obligations to certain employees in the event of
termination of their employment after or in connection with a change in control of the Company. In
addition, the Board of Directors has the authority, without further action by the stockholders, to
fix the rights and preferences of, and issue shares of, Preferred Stock. The staggered board terms,
Fair Price Provision, Stockholders Rights Agreement, severance arrangements, Preferred Stock
provisions and other provisions of our charter and Delaware corporate law may discourage certain
types of transactions involving an actual or potential change in control.
FORWARD-LOOKING STATEMENTS AND CAUTIONARY STATEMENTS
Statements in this prospectus and the documents incorporated by reference herein that are not
statements or descriptions of historical facts are forward-looking statements under Section 27A
of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private
Securities Litigation Reform Act of 1995, and
are subject to numerous risks and uncertainties. These forward-looking
23
statements and other
forward-looking statements made by us or our representatives are based on a number of assumptions.
The words believe, expect, anticipate, intend, estimate or other expressions, which are
predictions of or indicate future events and trends and which do not relate to historical matters,
identify forward-looking statements. The forward-looking statements represent our judgments and
expectations as of the date of this prospectus. We assume no obligation to update any such
forward-looking statements. Readers are cautioned not to place undue reliance on these
forward-looking statements, as they involve risks and uncertainties, and actual results could
differ materially from those currently anticipated due to a number of factors, including those set
forth in this section and elsewhere in this prospectus. These factors include, but are not limited
to, the risks set forth below.
The forward-looking statements set forth in this document represent our judgment and expectations
as of the date of this prospectus. We assume no obligation to update any such forward-looking
statements.
USE OF PROCEEDS
We will not receive any of the proceeds from the sale of the shares by the selling stockholders.
The warrants that have been issued to the selling stockholders to purchase 10,960,400 shares of our
common stock have an exercise price of $0.30 per share and a term of five years commencing six
months from the date of issue. The warrants are exercisable immediately for cash and via cashless
exercise. If all of the warrants were exercised for cash, we would receive approximately $3,288,120
in proceeds, which proceeds would be used for general corporate purposes.
SELLING STOCKHOLDERS
On April 21, 2006 we sold approximately $2.6 million worth of our common stock and warrants in a
private placement exempt from the registration requirements of the Securities Act. This prospectus
relates to the resale from time to time of up to a total of 21,920,800 shares of our common stock
by the selling stockholders, which shares are comprised of the following securities purchased in
the private placement:
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10,960,400 shares of common stock; and |
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10,960,400 shares of common stock issuable upon exercise of warrants at an exercise
price of $0.30 per share. |
Pursuant to the terms of the financing, we filed a Registration Statement on Form S-3, of which
this prospectus constitutes a part, in order to permit the selling stockholders to resell to the
public the shares of our common stock issued in connection with the private placement transaction.
The selling stockholders have each represented to us that they have obtained the shares for their
own account for investment only and not with a view to, or resale in connection with, a
distribution of the shares, except through sales registered under the Securities Act or exemptions
thereto.
The following table, to our knowledge, sets forth information regarding the beneficial ownership of
our common stock by the selling stockholders as of May 17, 2006 and the number of shares being
offered hereby by each selling stockholder. For purposes of the following description, the term
selling stockholder includes pledgees, donees, permitted transferees or other permitted
successors-in-interest selling shares received after the date of this prospectus from the selling
stockholders. The information is based in part on information provided by or on behalf of the
selling stockholders. Beneficial ownership is determined in accordance with the rules of the
Securities and Exchange Commission, and includes voting or investment power with respect to shares,
as well as any shares as to which the selling stockholder has the right to acquire beneficial
ownership within sixty (60) days after May 17, 2006 through the exercise or conversion of any stock
options, warrants, convertible debt or otherwise. The terms of the warrants provide that no selling
stockholder may exercise the warrants for shares of common stock for at least six months from the
date of issue. Notwithstanding the foregoing, all shares that are issuable to a selling stockholder
upon exercise of the warrants are included in the number of shares being offered in the table
below. Unless otherwise indicated below, each selling stockholder has sole voting and investment
power with respect to its shares of common stock. The inclusion of any shares in this table does
not constitute an admission of beneficial ownership by the selling stockholder. We will not receive
any of the proceeds from the sale of our common stock by the selling stockholders.
24
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SHARES |
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SHARES |
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BENEFICALLY |
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BENEFICALLY |
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OWNED BEFORE |
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SHARES |
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OWNED AFTER |
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OFFERING(1) |
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BEING |
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OFFERING(2) |
SELLING STOCKHOLDER |
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NUMBER |
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PERCENT |
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OFFERED |
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NUMBER |
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PERCENT |
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AJW Offshore, Ltd.(3) |
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472,400 |
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* |
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944,800 |
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0 |
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* |
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AJW Partners, LLC (4) |
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88,800 |
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* |
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177,600 |
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0 |
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* |
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AJW Qualified Partners, LLC (5) |
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228,000 |
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* |
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456,000 |
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0 |
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* |
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Bristol Investment Fund, Ltd. (6) |
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2,889,781 |
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4.19 |
% |
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3,200,000 |
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1,289,781 |
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1.87 |
% |
Cranshire Capital, L.P. (7) |
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1,200,000 |
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1.74 |
% |
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2,400,000 |
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0 |
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* |
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Crescent International Ltd. (8) |
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840,000 |
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1.22 |
% |
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1,680,000 |
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0 |
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* |
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Hudson Bay Fund LP (9) |
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400,000 |
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* |
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800,000 |
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0 |
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* |
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Icon Capital Partners LP (10) |
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400,000 |
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* |
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800,000 |
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0 |
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* |
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Iroquois Master Fund Ltd. (11) |
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600,000 |
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* |
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1,200,000 |
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0 |
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* |
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New Millennium Capital Partners II, LLC (12) |
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10,800 |
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* |
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21,600 |
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0 |
|
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* |
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Nite Capital LP (13) |
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1,200,000 |
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1.74 |
% |
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2,400,000 |
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0 |
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* |
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Noam J. Rubinstein (14) |
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100,000 |
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* |
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200,000 |
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0 |
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* |
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RAQ, LLC (15) |
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500,000 |
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* |
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1,000,000 |
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0 |
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* |
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Rodman & Renshaw, LLC (16) |
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1,172,284 |
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1.69 |
% |
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1,240,800 |
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551,884 |
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* |
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Smithfield Fiduciary LLC (17) |
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1,000,000 |
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1.45 |
% |
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2,000,000 |
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0 |
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* |
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Spectra Capital Management LLC (18) |
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800,000 |
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1.16 |
% |
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1,600,000 |
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0 |
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* |
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TCMP3 Partners L.P. (19) |
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400,000 |
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* |
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800,000 |
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0 |
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* |
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Valesco Healthcare Overseas Fund Ltd (20) |
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240,000 |
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* |
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480,000 |
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0 |
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* |
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Valesco Healthcare Partners I LP (21) |
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75,000 |
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* |
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150,000 |
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0 |
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* |
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Valesco Healthcare Partners II LP (22) |
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185,000 |
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* |
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370,000 |
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0 |
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* |
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* |
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Less than 1% |
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(1) |
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Percentages prior to the offering are based on 68,957,111 shares of common stock that were
issued and outstanding as of May 17, 2006. We deem shares of common stock that may be acquired
by an individual or group within 60 days of May 17, 2006 pursuant to the exercise of options
or warrants to be outstanding for the purpose of computing the percentage ownership of such
individual or group, but such shares are not deemed to be outstanding for the purpose of
computing the percentage ownership of any other individual or entity shown in the table. |
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(2) |
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We do not know when or in what amounts the selling stockholders may offer for sale the shares
of common stock pursuant to this offering. The selling stockholders may choose not to sell any
of the shares offered by this prospectus. Because the selling stockholders may offer all or
some of the shares of common stock pursuant to this offering, and because there are currently
no agreements, arrangements or undertakings with respect to the sale of any of the shares of
common stock, we cannot estimate the number of shares of common stock that the selling
stockholders will hold after completion of the offering. For purposes of this table, we have
assumed that the selling stockholders will have sold all of the shares covered by this
prospectus upon the completion of the offering. |
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(3) |
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The number of shares being offered consists of 472,400 shares of common stock and 472,400
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years for $0.30 per share. AJW Offshore,
Ltd., formerly known as AJW/New Millennium Offshore, Ltd., is a private investment fund that
is owned by its investors and managed by First Street Manager II, LLC. First Street Manager
II, LLC, of which Corey S. Ribotsky is the fund manager, has voting and investment control
over the shares owned by AJW Offshore, Ltd. |
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(4) |
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The number of shares being offered consists of 88,800 shares of common stock and 88,800
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years for $0.30 per share. AJW Partners, LLC
is a private investment fund that is owned by its investors and managed by SMS Group, LLC.
SMS Group, LLC, of which Mr. Corey S. Ribotsky is the fund manager, has voting and investment
control over the shares listed owned by AJW Partners, LLC. |
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(5) |
|
The number of shares being offered consists of 228,000 shares of common stock and 228,000
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years
for $0.30 per share. AJW Qualified Partners, LLC, formerly known as Pegasus Capital
Partners, LLC, is a private |
25
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investment fund that is owned by its investors and managed by AJW
Manager, LLC, of which Corey S. Ribotsky and Lloyd A. Groveman are the fund managers, have
voting and investment control over the shares listed owned by AJW Qualified Partners, LLC. |
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(6) |
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The number of shares being offered consists of 1,600,000 shares of common stock and 1,600,000
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years for $0.30 per share. Bristol
Capital Advisors, LLC (BCA) is the investment advisor to Bristol Investment Fund, Ltd.
(Bristol). Paul Kessler is the manager of BCA and as such has voting and investment control
over the securities held by Bristol. Mr. Kessler disclaims beneficial ownership of these
securities. |
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(7) |
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The number of shares being offered consists of 1,200,000 shares of common stock and 1,200,000
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years for $0.30 per share. Mitchell
P. Kopin, President of Downsview Capital, Inc., the general partner of Cranshire Capital, LP,
has sole voting control and dispositive powers of the securities held by Cranshire Capital,
L.P. Mr. Kopin disclaims all beneficial ownership of these securities. |
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(8) |
|
The number of shares being offered consists of 840,000 shares of common stock and 840,000
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years for $0.30 per share. Maxi Brezzi and
Bachir Taleb-Ibrahimi, in their capacity as managers of Cantara (Switzerland) SA, the
investment advisor to Crescent International Ltd., have voting control and investment
discretion over the shares owned by Crescent International Ltd. Messrs. Brezzi and
Taleb-Ibrahimi disclaim beneficial ownership of such shares. |
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(9) |
|
The number of shares being offered consists of 400,000 shares of common stock and 400,000
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years for $0.30 per share. |
|
(10) |
|
The number of shares being offered consists of 400,000 shares of common stock and 400,000
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years for $0.30 per share. |
|
(11) |
|
The number of shares being offered consists of 600,000 shares of common stock and 600,000
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years for $0.30 per share. |
|
(12) |
|
The number of shares being offered consists of 10,800 shares of common stock and 10,800
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years for $0.30 per share. New Millennium
Capital Partners II, LLC, is a private investment fund that is owned by its investors and
managed by First Street Manager II, LLC. First Street Manager II, LLC, of which Corey S.
Ribotsky is the fund manager, has voting and investment control over the shares owned by New
Millennium Capital Partners II, LLC. |
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(13) |
|
The number of shares being offered consists of 1,200,000 shares of common stock and 1,200,000
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years for $0.30 per share. |
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(14) |
|
The number of shares being offered consists of 100,000 shares of common stock and 100,000
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years for $0.30 per share. |
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(15) |
|
The number of shares being offered consists of 500,000 shares of common stock and 500,000
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years for $0.30 per share. |
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(16) |
|
The number of shares being offered consists of 620,400 shares of common stock and 620,400
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years for $0.30 per share. |
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(17) |
|
The number of shares being offered consists of 1,000,000 shares of common stock and 1,000,000
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years for $0.30 per share. Highbridge
Capital Management, LLC is the trading manager of Smithfield Fiduciary LLC and has voting
control and investment direction over securities held by Smithfield Fiduciary LLC. Glenn
Dubin and Henry Swieca control Highbridge Capital Management, LLC. Each of Highbridge Capital
Management, LLC, Glenn Dubin and Henry
Swieca disclaim beneficial ownership of the securities held by Smithfield Fiduciary LLC. |
26
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(18) |
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The number of shares being offered consists of 800,000 shares of common stock and 800,000
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years for $0.30 per share. |
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(19) |
|
The number of shares being offered consists of 400,000 shares of common stock and 400,000
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years for $0.30 per share. |
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(20) |
|
The number of shares being offered consists of 240,000 shares of common stock and 240,000
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years for $0.30 per share. |
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(21) |
|
The number of shares being offered consists of 75,000 shares of common stock and 75,000
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years for $0.30 per share. |
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(22) |
|
The number of shares being offered consists of 185,000 shares of common stock and 185,000
shares of common stock issuable upon exercise of warrants that are exercisable beginning six
months after April 19, 2006 for a period of five years for $0.30 per share. |
PLAN OF DISTRIBUTION
The shares covered by this prospectus may be offered and sold from time to time by the selling
stockholders. The term selling stockholder includes pledgees, donees, transferees or other
successors in interest selling shares received after the date of this prospectus from each selling
stockholder as a pledge, gift, partnership distribution or other non-sale related transfer. The
number of shares beneficially owned by a selling stockholder will decrease as and when it effects
any such transfers. The plan of distribution for the selling stockholders shares sold hereunder
will otherwise remain unchanged, except that the transferees, pledgees, donees or other successors
will be selling stockholders hereunder. To the extent required, we may amend and supplement this
prospectus from time to time to describe a specific plan of distribution.
The selling stockholders will act independently of us in making decisions with respect to the
timing, manner and size of each sale. The selling stockholders may make these sales at prices and
under terms then prevailing or at prices related to the then current market price. The selling
stockholders may also make sales in negotiated transactions. The selling stockholders may offer
their shares from time to time pursuant to one or more of the following methods:
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ordinary brokerage transactions and transactions in which the broker-dealer solicits
purchasers; |
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one or more block trades in which the broker-dealer will attempt to sell the shares as
agent but may position and resell a portion of the block as principal to facilitate the
transaction; |
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purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
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an exchange distribution in accordance with the rules of the applicable exchange; |
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privately negotiated transactions; |
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on the American Stock Exchange (or through the facilities of any national securities
exchange or U.S. inter-dealer quotation system of a registered national securities
association, on which the shares are then listed, admitted to unlisted trading privileges
or included for quotation); |
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through underwriters, brokers or dealers (who may act as agents or principals) or
directly to one or more purchasers; |
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settlement of short sales entered into after the effective date of the registration
statement of which this prospectus is a part; |
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broker-dealers may agree with the selling stockholders to sell a specified number of
such shares at a stipulated price per share; |
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through the writing or settlement of options or other hedging transactions, whether
through an options exchange or otherwise; |
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a combination of any such methods of sale; and |
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any other method permitted pursuant to applicable law. |
In addition to the foregoing methods, the selling stockholders may offer their shares from time to
time in transactions involving principals or brokers not otherwise contemplated above, in a
combination of such methods or described above or any other lawful methods. The selling
stockholders may also transfer, donate or assign their shares to lenders, family members and others
and each of such persons will be deemed to be a selling stockholder for purposes of this
prospectus. The selling stockholders or their successors in interest may from time to time pledge
or grant a security interest in some or all of the shares of common stock, and if the selling
stockholders default in the performance of their secured obligations, the pledgees or secured
parties may offer and sell the shares of common stock from time to time under this prospectus;
provided however in the event of a pledge or then default on a secured obligation by the selling
stockholder, in order for the shares to be sold under this registration statement, unless permitted
by law, we must distribute a prospectus supplement and/or amendment to this registration statement
amending the list of selling stockholders to include the pledgee, secured party or other successors
in interest of the selling stockholder under this prospectus.
The selling stockholders may also sell their shares pursuant to Rule 144 under the Securities Act,
which permits limited resale of shares purchased in a private placement subject to the satisfaction
of certain conditions, including, among other things, the availability of certain current public
information concerning the issuer, the resale occurring following the required holding period under
Rule 144 and the number of shares being sold during any three-month period not exceeding certain
limitations.
Sales through brokers may be made by any method of trading authorized by any stock exchange or
market on which the shares may be listed or quoted, including block trading in negotiated
transactions. Without limiting the foregoing, such brokers may act as dealers by purchasing any or
all of the shares covered by this prospectus, either as agents for others or as principals for
their own accounts, and reselling such shares pursuant to this prospectus. The selling stockholders
may effect such transactions directly, or indirectly through underwriters, broker-dealers or agents
acting on their behalf. In effecting sales, broker-dealers or agents engaged by the selling
stockholders may arrange for other broker-dealers to participate. Broker-dealers or agents may
receive commissions, discounts or concessions from the selling stockholders, in amounts to be
negotiated immediately prior to the sale (which compensation as to a particular broker-dealer might
be in excess of customary commissions for routine market transactions).
In offering the shares covered by this prospectus, the selling stockholders, and any broker-dealers
and any other participating broker-dealers who execute sales for the selling stockholders, may be
deemed to be underwriters within the meaning of the Securities Act in connection with these
sales. Any profits realized by the selling stockholders and the compensation of such broker-dealers
may be deemed to be underwriting discounts and commissions.
We are required to pay all fees and expenses incident to the registration of the shares.
We have agreed to indemnify the selling stockholders against certain losses, claims, damages and
liabilities, including liabilities under the Securities Act.
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LEGAL MATTERS
The validity of the common stock offered in this prospectus will be passed upon for us by
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., Boston, Massachusetts.
EXPERTS
The financial statements of Alteon as of December 31, 2005 and 2004, and for each of the years
then ended, have been incorporated by reference herein in reliance upon the report of J.H. Cohn
LLP, independent registered public accounting firm, and upon the authority of that firm as experts
in accounting and auditing.
J.H. Cohn LLP has included an explanatory paragraph in its report on our financial statements for
the fiscal year ended December 31, 2005, which expresses substantial doubt about our ability to
continue as a going concern.
The statements of operations, stockholders equity and cash flows of Alteon for the year ended
December 31, 2003, have been incorporated by reference herein and in the registration statement in
reliance upon the report of KPMG LLP, independent registered public accounting firm, incorporated
by reference herein, and upon the authority of said firm as experts in accounting and auditing.
MATERIAL CHANGES
On May 15, 2006, we announced that Kenneth I. Moch, our President and Chief Executive Officer,
was going to participate in the Rodman & Renshaw 3rd Annual Global Healthcare Conference in Monaco
on Monday, May 15, 2006 at 5:35 pm local time (11:35 am, ET), as previously announced on May 3,
2006. In addition, Noah Berkowitz, M.D., Ph.D., President and Chief Executive Officer of
HaptoGuard, who is expected to become our President and CEO upon the closing of the
previously-announced merger between the two companies, will review our and HaptoGuards clinical
programs. The previously-announced merger is subject to approval of our and HaptoGuards
stockholders and is expected to close in the third quarter of 2006.
Also on May 15, 2006, we issued a press release to report our financial results for the first
quarter ended March 31, 2006.
WHERE YOU CAN FIND MORE INFORMATION
We are a public company and file annual, quarterly and special reports, proxy statements and
other information with the Securities and Exchange Commission. You may read and copy any document
we file at the SECs Public Reference Room at 450 Fifth Street, N.W., Washington, D.C. 20549. You
can request copies of these documents by writing to the SEC and paying a fee for the copying cost.
Please call the SEC at 1-800-SEC-0330 for more information about the operation of the public
reference room. Our SEC filings are also available to the public at the SECs web site at
http://www.sec.gov, or at our web site at www.alteon.com. In addition, our common stock is listed
for trading on The American Stock Exchange under the symbol ALT.
This prospectus is only part of a Registration Statement on Form S-3 that we have filed with the
SEC under the Securities Act of 1933 and therefore omits certain information contained in the
Registration Statement. We have also filed exhibits and schedules with the Registration Statement
that are excluded from this prospectus, and you should refer to the applicable exhibit or schedule
for a complete description of any statement referring to any contract or other document. You may:
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inspect a copy of the Registration Statement, including the exhibits and schedules,
without charge at the public reference room, |
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obtain a copy from the SEC upon payment of the fees prescribed by the SEC, or |
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obtain a copy from the SEC web site. |
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INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The SEC allows us to incorporate by reference information from other documents that we file
with them, which means that we can disclose important information in this prospectus by referring
to those documents. The information incorporated by reference is considered to be part of this
prospectus, and information that we file later with the SEC will automatically update and supersede
the information in this prospectus. We incorporate by reference the documents listed below and any
future filings made with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Securities
Exchange Act of 1934. The documents we are incorporating by reference as of their respective dates
of filing are:
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Our Annual Report on Form 10-K for the year ended December 31, 2005, filed on March 30,
2006 (File No. 001-16043); |
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Our Current Report on Form 8-K (Rule 425 Communication), filed on April 19, 2006 (File
No. 001-16043); |
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Our Current Report on Form 8-K, filed on April 19, 2006 (File No. 001-16043); |
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Our Current Report on Form 8-K, filed on April 21, 2006 (File No. 001-16043); |
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Our Current Report on Form 8-K (Rule 425 Communication), filed on May 3, 2006 (File No.
001-16043); |
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Our Current Report on Form 8-K, filed on May 3, 2006 (File No. 001-16043); |
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Our Current Report on Form 8-K, filed on May 9, 2006 (File No. 001-16043); |
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Our Current Report on Form 8-K (Rule 425 Communication), filed on May 9, 2006 (File No.
001-16043); |
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Our Quarterly Report on Form 10-Q for the quarter ended March 31, 2006, filed on May 15,
2006 (File No. 001-16043); |
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Our Current Report on Form 8-K, filed on May 16, 2006 (File No. 001-16043); |
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Our Current Report on Form 8-K (Rule 425 Communication), filed on May 16, 2006 (File No.
001-16043); |
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Our Current Report on Form 8-K, filed on May 16, 2006 (File No. 001-16043); |
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Our Current Report on Form 8-K (Rule 425 Communication), filed on May 16, 2006 (File No.
001-16043); |
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Our Preliminary Proxy Statement on Schedule 14A, filed on
June 8, 2006 (File
No. 001-16043); and |
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The description of our common stock, $.01 par value, which is contained in our
Registration Statement on Form 8-A, filed November 1, 1991, including any amendments or
reports filed for the purpose of updating such description. |
You may request, orally or in writing, a copy of these filings, which will be provided to you at no
cost, by contacting Investor Relations c/o Nancy Regan, at our principal executive offices, which
are located at 6 Campus Drive, Parsippany, New Jersey; 07054, (201) 934-5000.
To the extent that any statements contained in a document incorporated by reference are modified or
superseded by any statements contained in this prospectus, such statements shall not be deemed
incorporated in this prospectus except as so modified or superseded.
All documents subsequently filed by us pursuant to Section 13(a), 13(c), 14 or 15(d) of the
Exchange Act and prior to the termination of this offering are incorporated by reference and become
a part of this prospectus from the date such documents are filed. Any statement contained in this
prospectus or in a document incorporated by reference is
modified or superseded for purposes of this prospectus to the extent that a statement contained in
any subsequent filed document modifies or supersedes such statement.
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