Unassociated Document
As
filed
with the Securities and Exchange Commission on June 17, 2008
Registration
No. 333-
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
S-3
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
HEMISPHERX
BIOPHARMA, INC.
(Exact
name of registrant as specified in its charter)
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Delaware
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2836
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52-0845822
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(State
or other jurisdiction of
incorporation
or organization)
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(Primary
Standard Industrial
Classification
Code Number)
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(I.R.S.
Employer
Identification
Number)
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1617
JFK
Boulevard
Philadelphia,
Pennsylvania 19103
(215)
988-0080
(Address,
including zip code, and telephone number, including area code, of registrant’s
principal executive offices)
William
A. Carter, M.D., Chief Executive Officer
Hemispherx
Biopharma, Inc.
1617
JFK
Boulevard
Philadelphia,
Pennsylvania 19103
(215)
988-0080
(Name,
address, including zip code, and telephone number, including area code, of
agent
for service)
Copies
of
all communications to:
Richard
Feiner, Esq.
Silverman
Sclar Shin & Byrne PLLC
381
Park
Avenue South, Suite 1601
New
York,
New York, 10016
(212)
779-8600
Fax
(212)
779-8858
Approximate
date of proposed sale to the public: From
time to time or at one time after the effective date of this Registration
Statement.
If
the
only securities being registered on this form are being offered pursuant to
dividend or interest reinvestment plans, please check the following box.
¨
If
any of
the securities being registered on this Form are to be offered on a delayed
or
continuous basis pursuant to Rule 415 under the Securities Act of 1933
("Securities Act"), other than securities offered only in connection with
dividend or reinvestment plans, check the following box. x
If
this
form is filed to register additional securities for an offering pursuant to
Rule
462(b) under the Securities Act, please check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same offering. ¨
If
this
form is a post-effective amendment filed pursuant to 462(c) under the Securities
Act, check the following box and list the Securities Act registration number
of
the earlier effective registration statement for the same offering.¨
If
this
Form is a registration statement pursuant to General Instruction I.D. or a
post-effective amendment thereto that shall become effective upon filing with
the Commission pursuant to Rule 462(e) under the Securities Act, check the
following box. ¨
If
this
Form is a post-effective amendment to a registration statement filed pursuant
to
General Instruction I.D. filed to register additional securities or additional
classes of securities pursuant to Rule 413(b) under the Securities Act, check
the following box. ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer or a smaller reporting company.
See
definition of "large accelerated filer,” “accelerated filer" and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
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Large
accelerated filer ¨
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Accelerated
filer x
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Non-accelerated
filer ¨
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Smaller
Reporting Company ¨
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CALCULATION
OF REGISTRATION FEE
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Title of Each Class of Securities to be
Registered
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Amount to be
Registered
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Proposed Maximum
Offering Price Per
Share
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Proposed Maximum
Aggregate Offering
Price
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Amount of Registration
Fee (1)
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Common
Stock, $0.001 par value per share
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(2
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)
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(3
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)
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(3
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)
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Preferred
Stock, $0.01 par value per share
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(2
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)
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(3
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)
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(3
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)
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|
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Warrants
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(2
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)
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(3
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)
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(3
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)
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Debt
Securities
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(2
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)
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(3
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)
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(3
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)
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|
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Total
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$
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50,000,000
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$
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1,965.00
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(1)
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Calculated
pursuant to Rule 457(o) under the Securities
Act.
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(2)
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There
are being registered hereunder such indeterminate number of shares
of
common stock and preferred stock, such indeterminate number of warrants
to
purchase common stock or preferred stock, and such indeterminate
principal
amount of debt securities as shall have an aggregate initial offering
price not to exceed in the aggregate $50,000,000. If any debt securities
are issued at an original issue discount, then the offering price
of such
debt securities shall be in such greater principal amount at maturity
as
shall result in an aggregate offering price not to exceed $50,000,000,
less the aggregate dollar amount of all securities previously issued
hereunder. Any securities registered hereunder may be sold separately
or
as units with other securities registered hereunder. The proposed
maximum
initial offering price per security will be determined, from time
to time,
by the registrant in connection with the issuance by the registrant
of the
securities registered hereunder. The securities registered also include
such indeterminate number of shares of common stock and preferred
stock
and amount of debt securities
as
may be issued upon conversion of or exchange for preferred
stock
or
debt securities
that provide for conversion or exchange, upon exercise of warrants
or
pursuant to the anti-dilution provisions of any such securities.
In
addition, pursuant to Rule 416 under the Securities Act, the securities
being registered hereunder include such indeterminate number of shares
of
common stock and preferred stock as may be issuable with respect
to the
shares being registered hereunder as a result of stock splits, stock
dividends or similar transactions.
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(3)
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The
proposed maximum aggregate offering price per class of security will
be
determined from time to time by the registrant in connection with
the
issuance by the registrant of the securities registered hereunder
and is
not specified as to each class of security pursuant to General Instruction
II.D. of Form S-3 under the Securities
Act.
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The
Registrant hereby amends this registration statement on the date or dates as
may
be necessary to delay its effective date until the Registrant shall file a
further amendment which specifically states that this registration statement
shall thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933, as amended, or until the registration statement shall
become effective on a date as the Securities and Exchange Commission, acting
pursuant to said Section 8(a), may determine.
The
information in this prospectus is not complete and may be amended. Neither
we
nor the selling stockholders may sell these securities until the registration
statement filed with the Securities and Exchange Commission is effective. This
prospectus is not an offer to sell these securities and it is not soliciting
an
offer to buy these securities in any state where an offer or sale is not
permitted.
Subject
to Completion
Preliminary
Prospectus Dated June 17, 2008
$50,000,000
HEMISPHERX
BIOPHARMA, INC.
Common
Stock
Preferred
Stock
Warrants
Debt
Securities
This
prospectus relates to common stock, preferred stock, debt securities and
warrants to purchase common stock, preferred stock or debt securities, either
individually or in units, as well as common stock or preferred stock upon
conversion of debt securities, common stock upon conversion of preferred stock,
or common stock or preferred stock upon the exercise of warrants that we may
sell from time to time in one or more offerings up to a total public offering
price of $50,000,000 on terms to be determined at the time of sale. We will
provide specific terms of these securities in supplements to this prospectus.
If
there is any inconsistency between the information in this prospectus and a
prospectus supplement, you should rely on the information in that prospectus
supplement. You should read this prospectus and any supplement carefully before
you invest.
This
prospectus may not be used to offer and sell securities unless accompanied
by a
prospectus supplement for those securities.
See
“Risk Factors” beginning on page 4 for a discussion of material risks that you
should consider before you invest in our securities being sold with this
prospectus.
Our
common stock is traded on the American Stock Exchange under the symbol “HEB.” On
June 2, 2008, the last reported sale price for our common stock on the American
Stock Exchange was $0.71 per share.
As
of
June 2, 2008, the aggregate market value of our outstanding common stock held
by
non-affiliates was approximately $52,623,459, based on 74,117,549 shares of
outstanding common stock, of which approximately 56,344,296 shares are held
by
non-affiliates, and a per share price of $0.71 based on the closing sale price
of our common stock on that date. As of the date hereof we have not offered
any
securities pursuant to General Instruction I.B.6 of Form S-3 during the prior
12
calendar month period that ends on and includes the date hereof.
Neither
the Securities and Exchange Commission nor any state securities commission
has
approved or disapproved of these securities or passed upon the adequacy or
accuracy of this prospectus. Any representation to the contrary is a criminal
offense.
The
date
of this prospectus is ,
2008.
TABLE
OF CONTENTS
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Page
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Prospectus
Summary
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2
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Risk
Factors
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4
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Special
Note Regarding Forward-Looking Statements
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18
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Ratio
Of Earnings To Fixed Charges
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18
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Use
of Proceeds
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18
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Description
of Capital Stock
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19
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Description
of Warrants
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21
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Description
of Debt Securities
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22
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Plan
of Distribution
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33
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Legal
Matters
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36
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Experts
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36
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Where
You Can Find More Information
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37
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Information
Incorporated By Reference
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37
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PROSPECTUS
SUMMARY
Important
Notice about the Information Presented in this
Prospectus
This
prospectus is part of a registration statement on Form S-3 that we filed with
the Securities and Exchange Commission, or SEC, utilizing a “shelf” registration
process. Under this shelf process, we may from time to time sell any combination
of securities described in this prospectus in one or more offerings. The
aggregate amount of securities that we may offer under the registration
statement is $50,000,000.
This
prospectus provides you with a general description of the securities we may
offer. Each time we sell securities, we will provide a prospectus supplement
that will contain specific information about the terms of the securities being
offered. That prospectus supplement may include a discussion of any risk factors
or other special consideration that apply to those securities. The prospectus
supplement may also add, update or change information contained in this
prospectus. If there is any inconsistency between the information in this
prospectus and a prospectus supplement, you should rely on the information
in
that prospectus supplement. You should read both this prospectus and any
applicable prospectus supplement together with additional information described
under the heading “Where You Can Find More Information.”
When
acquiring any securities discussed in this prospectus, you should rely on the
information provided in this prospectus and the prospectus supplement, including
the information incorporated by reference. Neither we, nor any underwriters
or
agents, have authorized anyone to provide you with different information. We
are
not offering the securities in any state where such an offer is prohibited.
You
should not assume that the information in this prospectus, any prospectus
supplement, or any document incorporated by reference, is truthful or complete
at any date other than the date mentioned on the cover page of those documents.
You should also carefully review the section entitled “Risk Factors,” which
highlights certain risks associated with an investment in our securities, to
determine whether an investment in our securities is appropriate for
you.
References
in this prospectus to “Hemispherx,” the “Company,” “we,” “us” and “our” are to
Hemispherx Biopharma, Inc.
About
Hemispherx
We
are a
biopharmaceutical company engaged in the clinical development, manufacture,
marketing and distribution of new drug therapies based on natural immune system
enhancing technologies for the treatment of viral and immune based chronic
disorders. We were founded in the early 1970s doing contract research for the
National Institutes of Health. Since that time, we have established a strong
foundation of laboratory, pre-clinical, and clinical data with respect to the
development of nucleic acids to enhance the natural antiviral defense system
of
the human body and to aid the development of therapeutic products for the
treatment of certain chronic diseases.
Our
current strategic focus is derived from four applications of our two core
pharmaceutical technology platforms Ampligen® and Alferon N Injection®. The
commercial focus for Ampligen includes application as a treatment for Chronic
Fatigue Syndrome (CFS) and as a vaccine enhancer (adjuvant) for both therapeutic
and preventative vaccine development. Alferon N Injection® is an FDA approved
product with an indication for refractory or recurring genital warts. Alferon
LDO (Low Dose Oral) is an application currently under early stage development
targeting influenza and viral diseases both as an adjuvant as well as a single
entity anti-viral.
Ampligen®
is an experimental drug currently undergoing clinical development for the
treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS” or
“CFS”), and HIV. We completed Phase III clinical trials using Ampligen® to treat
ME/CFS patients and are presently in the registration process for a new drug
application (“NDA”) with the Food and Drug Administration (“FDA”). On
December 5, 2007 we received a Refusal to File (“RTF”) letter from the FDA as
our NDA filing was deemed “not substantially complete”. We responded to the
FDA’s concerns on January 8, 2008 addressing their fourteen pre-clinical and
clinical questions. A scheduled Guidance Meeting with the FDA on February 8,
2008 resulted in resolving nine of the fourteen concerns. These nine are no
longer considered filing issues. The five remaining issues can be grouped into
two categories: 1) administrative items which include the submission of
additional clinical records, the clarification of some documents previously
submitted, additional clinical data reconciliation and additional charts, which
summarize specific parts of the clinical data, and 2) the reformatting and
enlarged analysis of the existing reports to more closely align with current
International Committee on Harmonization Guidelines. These five NDA filing
issues have been addressed by our clinical and scientific staff with the filing
of amendments to our NDA on April 25, 2008. These amendments should allow the
FDA reviewers to better evaluate independently the statistical efficacy/safety
conclusions of our NDA for the use of Ampligen in treating ME/CFS.
We
own
and operate a 43,000 sq. ft. FDA approved facility in New Brunswick, New Jersey
primarily designed to produce Alferon N. In 2006, we completed the installation
of a polymer production line to produce Ampligen® raw materials on a more
reliable and consistent basis.
Our
principal executive offices are located at One Penn Center, 1617 JFK Boulevard,
Philadelphia, Pennsylvania 19103, and our telephone number is
215-988-0080.
We
maintain a website at “http://www.hemispherx.net.” Information contained on our
website is not considered to be a part of, nor incorporated by reference in,
this prospectus.
RISK
FACTORS
The
following cautionary statements identify important factors that could cause
our
actual results to differ materially from those projected in the forward-looking
statements made in this prospectus. Among the key factors that have a direct
bearing on our results of operations are:
Risks
Associated With Our Business
No
assurance of successful product development.
Ampligen®
and related products.
The
development of Ampligen® and
our
other related products is subject to a number of significant risks.
Ampligen® may
be
found to be ineffective or to have adverse side effects, fail to receive
necessary regulatory clearances, be difficult to manufacture on a commercial
scale, be uneconomical to market or be precluded from commercialization by
proprietary right of third parties. Our products are in various stages of
clinical and pre-clinical development and require further clinical studies
and
appropriate regulatory approval processes before any such products can be
marketed. We do not know when, if ever, Ampligen® or
our
other products will be generally available for commercial sale for any
indication. Generally, only a small percentage of potential therapeutic products
are eventually approved by the FDA for commercial sale. Please see the next
risk
factor.
Alferon
N Injection®.
Although Alferon N Injection® is approved for marketing in the United States for
the intra-lesional treatment of refractory or recurring external genital warts
in patients 18 years of age or older, to date it has not been approved for
other
indications. We face many of the risks discussed above, with regard to
developing this product for use to treat other ailments.
Our
drug and related technologies are investigational and subject to regulatory
approval. If we are unable to obtain regulatory approval, our operations will
be
significantly adversely affected.
All
of
our drugs and associated technologies, other than Alferon N Injection®, are
investigational and must receive prior regulatory approval by appropriate
regulatory authorities for general use and are currently legally available
only
through clinical trials with specified disorders. At present, Alferon N
Injection® is only approved for the intra-lesional treatment of refractory or
recurring external genital warts in patients 18 years of age or older. Use
of
Alferon N Injection® for other indications will require regulatory
approval.
Our
products, including Ampligen®, are subject to extensive regulation by numerous
governmental authorities in the U.S. and other countries, including, but not
limited to, the FDA in the U.S., the Health Protection Branch (“HPB”) of Canada,
and the Agency for the Evaluation of Medicinal Products (“EMEA”) in Europe.
Obtaining regulatory approvals is a rigorous and lengthy process and requires
the expenditure of substantial resources. In order to obtain final regulatory
approval of a new drug, we must demonstrate to the satisfaction of the
regulatory agency that the product is safe and effective for its intended uses
and that we are capable of manufacturing the product to the applicable
regulatory standards. We require regulatory approval in order to market
Ampligen® or any other proposed product and receive product revenues or
royalties. We cannot assure you that Ampligen® will ultimately be demonstrated
to be safe or efficacious. In addition, while Ampligen® is authorized for use in
clinical trials including a cost recovery program in the United States and
Europe, we cannot assure you that additional clinical trial approvals will
be
authorized in the United States or in other countries, in a timely fashion
or at
all, or that we will complete these clinical trials.
We
filed
an NDA with the FDA for treatment of CFS on October 10, 2007. On December 5,
2007 we received an RTF letter from the FDA as our NDA filing was deemed “not
substantially complete”. We responded to the FDA’s concerns on January 8, 2008
addressing their fourteen pre-clinical and clinical questions. A scheduled
Guidance Meeting with the FDA on February 8, 2008 resulted in resolving nine
of
the fourteen concerns. These nine are no longer considered filing issues. The
five remaining issues can be grouped into two categories: 1) administrative
items which include the submission of additional clinical records, the
clarification of some documents previously submitted, additional clinical data
reconciliation and additional charts, which summarize specific parts of the
clinical data, and 2) the reformatting and enlarged analysis of the existing
reports to more closely align with current International Committee on
Harmonization Guidelines.
These
five NDA filing issues have been addressed by our clinical and scientific staff
with the filing of amendments to our NDA on April 25, 2008. These amendments
should allow the FDA reviewers to better evaluate independently the statistical
efficacy/safety conclusions of our NDA for the use of Ampligen in treating
ME/CFS. However, there are no assurances the FDA will accept the amended NDA
for
review, and if accepted, there are no assurances that the NDA will be
approved.
If
Ampligen® or one of our other products does not receive regulatory approval in
the U.S. or elsewhere, our operations most likely will be materially adversely
affected.
Although
preliminary in vitro testing indicates that Ampligen® enhances the effectiveness
of different drug combinations on avian influenza, preliminary testing in the
laboratory is not necessarily predictive of successful results in clinical
testing or human treatment.
Ampligen®
is undergoing pre-clinical testing for possible treatment of avian flu. Although
preliminary in vitro testing indicates that Ampligen® enhances the effectiveness
of different drug combinations on avian flu, preliminary testing in the
laboratory is not necessarily predictive of successful results in clinical
testing or human treatment. No assurance can be given that similar results
will
be observed in clinical trials. Use of Ampligen® in the treatment of avian flu
requires prior regulatory approval. Only the FDA can determine whether a drug
is
safe, effective or promising for treating a specific application. As discussed
in the prior risk factor, obtaining regulatory approvals is a rigorous and
lengthy process.
In
addition, Ampligen® is being tested on two strains of avian influenza virus.
There are a number of strains and strains mutate. No assurance can be given
that
Ampligen® will be effective on any strains that might infect
humans.
We
may continue to incur substantial losses and our future profitability is
uncertain.
We
began
operations in 1966 and last reported net profit from 1985 through 1987. Since
1987, we have incurred substantial operating losses, as we pursued our clinical
trial effort to get our experimental drug, Ampligen®, approved. As of March 31,
2008, our accumulated deficit was approximately $188,355,000. We have not yet
generated significant revenues from our products and may incur substantial
and
increased losses in the future. We cannot assure that we will ever achieve
significant revenues from product sales or become profitable. We require, and
will continue to require, the commitment of substantial resources to develop
our
products. We cannot assure that our product development efforts will be
successfully completed or that required regulatory approvals will be obtained
or
that any products will be manufactured and marketed successfully, or be
profitable.
We
may require additional financing which may not be
available.
The
development of our products will require the commitment of substantial resources
to conduct the time-consuming research, preclinical development, and clinical
trials that are necessary to bring pharmaceutical products to market. As of
May
31, 2008, we had approximately $10,763,000 in cash and cash equivalents and
short-term investments. We anticipate, but cannot assure, that these funds
will
be sufficient to meet our operating cash requirements for the next 13 months.
We
anticipate, but cannot assure, that we will be able to raise additional capital
from the sale of securities registered herein. In addition, in April 2006,
we
entered into a common stock purchase agreement with Fusion Capital pursuant
to
which Fusion Capital agreed, under certain conditions and with certain
limitations, to purchase on each trading day $100,000 of our common stock until
August 1, 2008. Fusion Capital does not have the right nor the obligation to
purchase any shares of our common stock on any trading days that the market
price of our common stock is less than $1.00. Unless and until the market price
for our common stock increases to at least $1.00 (the closing sale price of
the
common stock on June 2, 2008 was $0.71), no additional shares will be sold
to
Fusion Capital under the agreement. Should our price so rise, and assuming
a
purchase price of $1.00 per share and the purchase by Fusion Capital of the
remaining 1,061,189 shares, total gross proceeds to us from the remaining shares
would only be approximately $1,061,000.
Assuming
no material financing from the sale of securities pursuant to this prospectus
or
from Fusion Capital and if we are unable to commercialize and sell Ampligen®
and/or increase sales of Alferon N Injection® or our other products, we will
need to secure other sources of funding through additional equity or debt
financing or from other sources in order to satisfy our working capital needs
and to complete the necessary clinical trials and the regulatory approval
processes including the commercializing of Ampligen® products. There can be no
assurances that we will raise adequate funds which may have a material adverse
effect on our ability to develop our products.
We
may not be profitable unless we can protect our patents and/or receive approval
for additional pending patents.
We
need
to preserve and acquire enforceable patents covering the use of Ampligen® for a
particular disease in order to obtain exclusive rights for the commercial sale
of Ampligen® for such disease. We obtained all rights to Alferon N Injection®,
and we plan to preserve and acquire enforceable patents covering its use for
existing and potentially new diseases. Our success depends, in large part,
on
our ability to preserve and obtain patent protection for our products and to
obtain and preserve our trade secrets and expertise. Certain of our know-how
and
technology is not patentable, particularly the procedures for the manufacture
of
our experimental drug, Ampligen®, which is carried out according to standard
operating procedure manuals. We have been issued certain patents including
those
on the use of Ampligen® and Ampligen® in combination with certain other drugs
for the treatment of HIV. We also have been issued patents on the use of
Ampligen® in combination with certain other drugs for the treatment of chronic
Hepatitis B virus, chronic Hepatitis C virus, and a patent which affords
protection on the use of Ampligen® in patients with Chronic Fatigue Syndrome. We
have not yet been issued any patents in the United States for the use of
AmpligenÒ
as a
sole treatment for any of the cancers, which we have sought to target. With
regard to Alferon N Injection®, we have acquired from ISI its patents for
natural alpha interferon produced from human peripheral blood leukocytes and
its
production process and we have filed a patent application for the use of
Alferon® LDO in treating viral diseases including avian influenza. We cannot
assure that our competitors will not seek and obtain patents regarding the
use
of similar products in combination with various other agents, for a particular
target indication prior to our doing such. If we cannot protect our patents
covering the use of our products for a particular disease, or obtain additional
patents, we may not be able to successfully market our products.
The
patent position of biotechnology and pharmaceutical firms is highly uncertain
and involves complex legal and factual questions.
To
date,
no consistent policy has emerged regarding the breadth of protection afforded
by
pharmaceutical and biotechnology patents. There can be no assurance that new
patent applications relating to our products or technology will result in
patents being issued or that, if issued, such patents will afford meaningful
protection against competitors with similar technology. It is generally
anticipated that there may be significant litigation in the industry regarding
patent and intellectual property rights. Such litigation could require
substantial resources from us and we may not have the financial resources
necessary to enforce the patent rights that we hold. No assurance can be made
that our patents will provide competitive advantages for our products or will
not be successfully challenged by competitors. No assurance can be given that
patents do not exist or could not be filed which would have a materially adverse
effect on our ability to develop or market our products or to obtain or maintain
any competitive position that we may achieve with respect to our products.
Our
patents also may not prevent others from developing competitive products using
related technology.
There
can be no assurance that we will be able to obtain necessary licenses if we
cannot enforce patent rights we may hold. In addition, the failure of third
parties from whom we currently license certain proprietary information or from
whom we may be required to obtain such licenses in the future, to adequately
enforce their rights to such proprietary information, could adversely affect
the
value of such licenses to us.
If
we
cannot enforce the patent rights we currently hold we may be required to obtain
licenses from others to develop, manufacture or market our products. There
can
be no assurance that we would be able to obtain any such licenses on
commercially reasonable terms, if at all. We currently license certain
proprietary information from third parties, some of which may have been
developed with government grants under circumstances where the government
maintained certain rights with respect to the proprietary information developed.
No assurances can be given that such third parties will adequately enforce
any
rights they may have or that the rights, if any, retained by the government
will
not adversely affect the value of our license.
There
is no guarantee that our trade secrets will not be disclosed or known by our
competitors.
To
protect our rights, we require certain employees and consultants to enter into
confidentiality agreements with us. There can be no assurance that these
agreements will not be breached, that we would have adequate and enforceable
remedies for any breach, or that any trade secrets of ours will not otherwise
become known or be independently developed by competitors.
We
have limited marketing and sales capability. If we are unable to obtain
additional distributors and our current and future distributors do not market
our products successfully, we may not generate significant revenues or become
profitable.
We
have
limited marketing and sales capability. We are dependent upon existing and,
possibly future, marketing agreements and third party distribution agreements
for our products in order to generate significant revenues and become
profitable. As a result, any revenues received by us will be dependent in large
part on the efforts of third parties, and there is no assurance that these
efforts will be successful.
Our
commercialization strategy for Ampligen-CFS may include licensing/co-marketing
agreements utilizing the resources and capacities of a strategic partner(s).
We
are currently seeking worldwide marketing partner(s), with the goal of having
a
relationship in place before approval is obtained. In parallel to partnering
discussions, appropriate pre-marketing activities will be undertaken. We intend
to control manufacturing of Ampligen on a worldwide basis.
We
cannot
assure that our U.S. or foreign marketing strategy will be successful or that
we
will be able to establish future marketing or third party distribution
agreements on terms acceptable to us, or that the cost of establishing these
arrangements will not exceed any product revenues. Our inability to establish
viable marketing and sales capabilities would most likely have a materially
adverse effect on us.
There
are no long-term agreements with suppliers of required materials. If we are
unable to obtain the required raw materials, we may be required to scale back
our operations or stop manufacturing Alferon N Injection® and/or
Ampligen®.
A
number
of essential materials are used in the production of Alferon N Injection®,
including human white blood cells. We do not have long-term agreements for
the
supply of any of such materials. There can be no assurance we can enter into
long-term supply agreements covering essential materials on commercially
reasonable terms, if at all.
There
are
a limited number of manufacturers in the United States available to provide
the
polymers for use in manufacturing Ampligen®. At present, we do not have any
agreements with third parties for the supply of any of these polymers. We have
established relevant manufacturing operations within our New Brunswick, New
Jersey facility for the production of Ampligen® polymers from raw materials in
order to obtain polymers on a more consistent manufacturing basis.
If
we are
unable to obtain or manufacture the required polymers, we may be required to
scale back our operations or stop manufacturing. The costs and availability
of
products and materials we need for the production of Ampligen® and the
commercial production of Alferon N Injection® and other products which we may
commercially produce are subject to fluctuation depending on a variety of
factors beyond our control, including competitive factors, changes in
technology, and FDA and other governmental regulations and there can be no
assurance that we will be able to obtain such products and materials on terms
acceptable to us or at all.
There
is no assurance that successful manufacture of a drug on a limited scale basis
for investigational use will lead to a successful transition to commercial,
large-scale production.
Small
changes in methods of manufacturing, including commercial scale-up, may affect
the chemical structure of Ampligen® and other RNA drugs, as well as their safety
and efficacy, and can, among other things, require new clinical studies and
affect orphan drug status, particularly, market exclusivity rights, if any,
under the Orphan Drug Act. The transition from limited production of
pre-clinical and clinical research quantities to production of commercial
quantities of our products will involve distinct management and technical
challenges and will require additional management and technical personnel and
capital to the extent such manufacturing is not handled by third parties. There
can be no assurance that our manufacturing will be successful or that any given
product will be determined to be safe and effective, capable of being
manufactured economically in commercial quantities or successfully
marketed.
We
have limited manufacturing experience and capacity.
Ampligen®
has been only produced in limited quantities for use in our clinical trials
and
we are dependent upon a third party supplier for substantially all of the
production process. The failure to continue these arrangements or to achieve
other such arrangements on satisfactory terms could have a material adverse
affect on us. Also, to be successful, our products must be manufactured in
commercial quantities in compliance with regulatory requirements and at
acceptable costs. To the extent we are involved in the production process,
our
current facilities are not adequate for the production of our proposed products
for large-scale commercialization, and we currently do not have adequate
personnel to conduct commercial-scale manufacturing. We intend to utilize
third-party facilities if and when the need arises or, if we are unable to
do
so, to build or acquire commercial-scale manufacturing facilities. We will
need
to comply with regulatory requirements for such facilities, including those
of
the FDA pertaining to current Good Manufacturing Practices (“cGMP”) regulations.
There can be no assurance that such facilities can be used, built, or acquired
on commercially acceptable terms, or that such facilities, if used, built,
or
acquired, will be adequate for our long-term needs.
We
may not be profitable unless we can produce Ampligen® or other products in
commercial quantities at costs acceptable to us.
We
have
never produced Ampligen® or any other products in large commercial quantities.
We must manufacture our products in compliance with regulatory requirements
in
large commercial quantities and at acceptable costs in order for us to be
profitable. We intend to utilize third-party manufacturers and/or facilities
if
and when the need arises or, if we are unable to do so, to build or acquire
commercial-scale manufacturing facilities. If we cannot manufacture commercial
quantities of Ampligen® or enter into third party agreements for its manufacture
at costs acceptable to us, our operations will be significantly affected. Also,
each production lot of Alferon N Injection® is subject to FDA review and
approval prior to releasing the lots to be sold. This review and approval
process could take considerable time, which would delay our having product
in
inventory to sell.
Rapid
technological change may render our products obsolete or
non-competitive.
The
pharmaceutical and biotechnology industries are subject to rapid and substantial
technological change. Technological competition from pharmaceutical and
biotechnology companies, universities, governmental entities and others
diversifying into the field is intense and is expected to increase. Most of
these entities have significantly greater research and development capabilities
than us, as well as substantial marketing, financial and managerial resources,
and represent significant competition for us. There can be no assurance that
developments by others will not render our products or technologies obsolete
or
noncompetitive or that we will be able to keep pace with technological
developments.
Our
products may be subject to substantial competition.
Ampligen®.
Competitors may be developing technologies that are, or in the future may be,
the basis for competitive products. Some of these potential products may have
an
entirely different approach or means of accomplishing similar therapeutic
effects to products being developed by us. These competing products may be
more
effective and less costly than our products. In addition, conventional drug
therapy, surgery and other more familiar treatments may offer competition to
our
products. Furthermore, many of our competitors have significantly greater
experience than us in pre-clinical testing and human clinical trials of
pharmaceutical products and in obtaining FDA, HPB and other regulatory approvals
of products. Accordingly, our competitors may succeed in obtaining FDA, HPB
or
other regulatory product approvals more rapidly than us. There are no drugs
approved for commercial sale with respect to treating ME/CFS in the United
States. The dominant competitors with drugs to treat disease indications in
which we plan to address include Gilead Pharmaceutical, Pfizer, Bristol-Myers,
Abbott Labs, Glaxo Smith Kline, Merck and Schering-Plough Corp. These potential
competitors are among the largest pharmaceutical companies in the world, are
well known to the public and the medical community, and have substantially
greater financial resources, product development, and manufacturing and
marketing capabilities than we have. Although we believe our principal advantage
is the unique mechanism of action of Ampligen® on the immune system, we cannot
assure that we will be able to compete.
ALFERON
N
Injection®. Our competitors are among the largest pharmaceutical companies in
the world, are well known to the public and the medical community, and have
substantially greater financial resources, product development, and
manufacturing and marketing capabilities than we have. Alferon N Injection®
currently competes with Schering’s injectable recombinant alpha interferon
product (INTRON® A) for the treatment of genital warts. 3M Pharmaceuticals also
offer competition from its immune-response modifier, Aldara®, a
self-administered topical cream, for the treatment of external genital and
perianal warts. In addition, Medigene recently received FDA approval for a
self-administered ointment, VeregenTM, which is indicated for the topical
treatment of external genital and perianal warts. Alferon N Injection® also
competes with surgical, chemical, and other methods of treating genital warts.
We cannot assess the impact products developed by our competitors, or advances
in other methods of the treatment of genital warts, will have on the commercial
viability of Alferon N Injection®. If and when we obtain additional approvals of
uses of this product, we expect to compete primarily on the basis of product
performance. Our competitors have developed or may develop products (containing
either alpha or beta interferon or other therapeutic compounds) or other
treatment modalities for those uses. There can be no assurance that, if we
are
able to obtain regulatory approval of Alferon N Injection® for the treatment of
new indications, we will be able to achieve any significant penetration into
those markets. In addition, because certain competitive products are not
dependent on a source of human blood cells, such products may be able to be
produced in greater volume and at a lower cost than Alferon N Injection®.
Currently, our wholesale price on a per unit basis of Alferon N Injection® is
higher than that of the competitive recombinant alpha and beta interferon
products.
General.
Other companies may succeed in developing products earlier than we do, obtaining
approvals for such products from the FDA more rapidly than we do, or developing
products that are more effective than those we may develop. While we will
attempt to expand our technological capabilities in order to remain competitive,
there can be no assurance that research and development by others or other
medical advances will not render our technology or products obsolete or
non-competitive or result in treatments or cures superior to any therapy we
develop.
Possible
side effects from the use of Ampligen® or Alferon N Injection® could adversely
affect potential revenues and physician/patient acceptability of our
product.
Ampligen®.
We believe that Ampligen® has been generally well tolerated with a low incidence
of clinical toxicity, particularly given the severely debilitating or life
threatening diseases that have been treated. A mild flushing reaction has been
observed in approximately 15% of patients treated in our various studies. This
reaction is occasionally accompanied by a rapid heart beat, a tightness of
the
chest, urticaria (swelling of the skin), anxiety, shortness of breath,
subjective reports of ''feeling hot'', sweating and nausea. The reaction is
usually infusion-rate related and can generally be controlled by reducing the
rate of infusion. Other adverse side effects include liver enzyme level
elevations, diarrhea, itching, asthma, low blood pressure, photophobia, rash,
transient visual disturbances, slow or irregular heart rate, decreases in
platelets and white blood cell counts, anemia, dizziness, confusion, elevation
of kidney function tests, occasional temporary hair loss and various flu-like
symptoms, including fever, chills, fatigue, muscular aches, joint pains,
headaches, nausea and vomiting. These flu-like side effects typically subside
within several months. One or more of the potential side effects might deter
usage of Ampligen® in certain clinical situations and therefore, could adversely
affect potential revenues and physician/patient acceptability of our product.
Alferon
N
Injection®. At present, Alferon N Injection® is only approved for the
intra-lesional (within the lesion) treatment of refractory or recurring external
genital warts in adults. In clinical trials conducted for the treatment of
genital warts with Alferon N Injection®, patients did not experience serious
side effects; however, there can be no assurance that unexpected or unacceptable
side effects will not be found in the future for this use or other potential
uses of Alferon N Injection® which could threaten or limit such product’s
usefulness.
We
may be subject to product liability claims from the use of Ampligen®, Alferon N
Injection®, or other of our products which could negatively affect our future
operations.
We
face
an inherent business risk of exposure to product liability claims in the event
that the use of Ampligen® or other of our products results in adverse effects.
This liability might result from claims made directly by patients, hospitals,
clinics or other consumers, or by pharmaceutical companies or others
manufacturing these products on our behalf. Our future operations may be
negatively affected from the litigation costs, settlement expenses and lost
product sales inherent to these claims. While we will continue to attempt to
take appropriate precautions, we cannot assure that we will avoid significant
product liability exposure. Although we currently maintain product liability
insurance coverage, there can be no assurance that this insurance will provide
adequate coverage against Ampligen® and/or Alferon N Injection® product
liability claims. A successful product liability claim against us in excess
of
Ampligen’s® $1,000,000 in insurance coverage; $3,000,000 in aggregate, or in
excess of Alferon N Injection’s® $5,000,000 in insurance coverage; $5,000,000 in
aggregate; or for which coverage is not provided could have a negative effect
on
our business and financial condition.
The
loss of services of key personnel including Dr. William A. Carter could hurt
our
chances for success.
Our
success is dependent on the continued efforts of Dr. William A. Carter because
of his position as a pioneer in the field of nucleic acid drugs, his being
the
co-inventor of Ampligen®, and his knowledge of our overall activities, including
patents and clinical trials. The loss of Dr. Carter’s services could have a
material adverse effect on our operations and chances for success. We have
secured key man life insurance in the amount of $2,000,000 on the life of Dr.
Carter and we have an employment agreement with Dr. Carter that, as amended,
runs until December 31, 2010. However, Dr. Carter has the right to terminate
his
employment upon not less than 30 days prior written notice. The loss of Dr.
Carter or other personnel or the failure to recruit additional personnel as
needed could have a materially adverse effect on our ability to achieve our
objectives.
Uncertainty
of health care reimbursement for our products.
Our
ability to successfully commercialize our products will depend, in part, on
the
extent to which reimbursement for the cost of such products and related
treatment will be available from government health administration authorities,
private health coverage insurers and other organizations. Significant
uncertainty exists as to the reimbursement status of newly approved health
care
products, and from time to time legislation is proposed, which, if adopted,
could further restrict the prices charged by and/or amounts reimbursable to
manufacturers of pharmaceutical products. We cannot predict what, if any,
legislation will ultimately be adopted or the impact of such legislation on
us.
There can be no assurance that third party insurance companies will allow us
to
charge and receive payments for products sufficient to realize an appropriate
return on our investment in product development.
There
are risks of liabilities associated with handling and disposing of hazardous
materials.
Our
business involves the controlled use of hazardous materials, carcinogenic
chemicals, flammable solvents and various radioactive compounds. Although we
believe that our safety procedures for handling and disposing of such materials
comply in all material respects with the standards prescribed by applicable
regulations, the risk of accidental contamination or injury from these materials
cannot be completely eliminated. In the event of such an accident or the failure
to comply with applicable regulations, we could be held liable for any damages
that result, and any such liability could be significant. We do not maintain
insurance coverage against such liabilities.
Risks
Associated With an Investment in Our Common Stock
The
market price of our stock may be adversely affected by market
volatility.
The
market price of our common stock has been and is likely to be volatile. In
addition to general economic, political and market conditions, the price and
trading volume of our stock could fluctuate widely in response to many factors,
including:
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announcements
of the results of clinical trials by us or our
competitors;
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adverse
reactions to products;
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·
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governmental
approvals, delays in expected governmental approvals or withdrawals
of any
prior governmental approvals or public or regulatory agency concerns
regarding the safety or effectiveness of our
products;
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changes
in U.S. or foreign regulatory policy during the period of product
development;
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developments
in patent or other proprietary rights, including any third party
challenges of our intellectual property
rights;
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announcements
of technological innovations by us or our
competitors;
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announcements
of new products or new contracts by us or our
competitors;
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actual
or anticipated variations in our operating results due to the level
of
development expenses and other
factors;
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changes
in financial estimates by securities analysts and whether our earnings
meet or exceed the estimates;
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conditions
and trends in the pharmaceutical and other
industries;
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new
accounting standards; and
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the
occurrence of any of the risks described in these "Risk
Factors."
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Our
common stock is listed for quotation on the American Stock Exchange. For the
12-month period ended May 31, 2008, the closing price of our common stock has
ranged from $0.61 to $2.00 per share. We expect the price of our common stock
to
remain volatile. The average daily trading volume of our common stock varies
significantly. Our relatively low average volume and low average number of
transactions per day may affect the ability of our stockholders to sell their
shares in the public market at prevailing prices and a more active market may
never develop.
In
the
past, following periods of volatility in the market price of the securities
of
companies in our industry, securities class action litigation has often been
instituted against companies in our industry. If we face securities litigation
in the future, even if without merit or unsuccessful, it would result in
substantial costs and a diversion of management attention and resources, which
would negatively impact our business.
Our
stock price may be adversely affected if a significant amount of shares are
sold
in the public market.
We
have
registered $50,000,000 of securities for public sale pursuant to this
prospectus. In addition, 1,704,691 shares of our common stock are registered
for
public resale consisting of shares currently owned by Fusion Capital and shares
issuable under the Fusion Capital common stock purchase agreement. Also, we
have
registered 135% of 3,615,514 shares issuable upon exercise of Warrants related
to our former convertible debentures and 5,594,104 shares issuable upon exercise
of certain other warrants. Registration of the shares permits the sale of the
shares in the open market or in privately negotiated transactions without
compliance with the requirements of Rule 144. To the extent the exercise price
of the warrants is less than the market price of the common stock, the holders
of the warrants are likely to exercise them and sell the underlying shares
of
common stock and to the extent that the conversion price and exercise price
of
these securities are adjusted pursuant to anti-dilution protection, the
securities could be exercisable or convertible for even more shares of common
stock. We also may issue shares pursuant to this prospectus or otherwise to
be
used to meet our capital requirements or use shares to compensate employees,
consultants and/or directors. We are unable to estimate the amount, timing
or
nature of future sales of outstanding common stock. Sales of substantial amounts
of our common stock in the public market could cause the market price for our
common stock to decrease. Furthermore, a decline in the price of our common
stock would likely impede our ability to raise capital through the issuance
of
additional shares of common stock or other equity securities.
Significant
sales pursuant to this prospectus or to Fusion Capital may cause
dilution.
The
issuance of a significant number of securities under this prospectus or shares
to Fusion Capital under the common stock purchase agreement will dilute the
equity interest of existing stockholders and could have an adverse effect on
the
market price of our common stock.
Provisions
of our Certificate of Incorporation and Delaware law could defer a change of
our
management which could discourage or delay offers to acquire
us.
Provisions
of our Certificate of Incorporation and Delaware law may make it more difficult
for someone to acquire control of us or for our stockholders to remove existing
management, and might discourage a third party from offering to acquire us,
even
if a change in control or in management would be beneficial to our stockholders.
For example, our Certificate of Incorporation allows us to issue shares of
preferred stock without any vote or further action by our stockholders. Our
Board of Directors has the authority to fix and determine the relative rights
and preferences of preferred stock. Our Board of Directors also has the
authority to issue preferred stock without further stockholder approval. As
a
result, our Board of Directors could authorize the issuance of a series of
preferred stock that would grant to holders the preferred right to our assets
upon liquidation, the right to receive dividend payments before dividends are
distributed to the holders of common stock and the right to the redemption
of
the shares, together with a premium, prior to the redemption of our common
stock. In this regard, in November 2002, we adopted a stockholder rights plan
and, under the Plan, our Board of Directors declared a dividend distribution
of
one Right for each outstanding share of Common Stock to stockholders of record
at the close of business on November 29, 2002. Each Right initially entitles
holders to buy one unit of preferred stock for $30.00. The Rights generally
are
not transferable apart from the common stock and will not be exercisable unless
and until a person or group acquires or commences a tender or exchange offer
to
acquire, beneficial ownership of 15% or more of our common stock. However,
for
Dr. Carter, our chief executive officer, who already beneficially owns 7.8%
of
our common stock, the Plan’s threshold will be 20%, instead of 15%. The Rights
will expire on November 19, 2012, and may be redeemed prior thereto at $.01
per
Right under certain circumstances.
Because
the risk factors referred to above could cause actual results or outcomes to
differ materially from those expressed in any forward-looking statements made
by
us, you should not place undue reliance on any such forward-looking statements.
Further, any forward-looking statement speaks only as of the date on which
it is
made and we undertake no obligation to update any forward-looking statement
or
statements to reflect events or circumstances after the date on which such
statement is made or reflect the occurrence of unanticipated events. New factors
emerge from time to time, and it is not possible for us to predict which will
arise. In addition, we cannot assess the impact of each factor on our business
or the extent to which any factor, or combination of factors, may cause actual
results to differ materially from those contained in any forward-looking
statements. Our research in clinical efforts may continue for the next several
years and we may continue to incur losses due to clinical costs incurred in
the
development of Ampligen® for commercial application. Possible losses may
fluctuate from quarter to quarter as a result of differences in the timing
of
significant expenses incurred and receipt of licensing fees and/or cost recovery
treatment revenue.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain
statements in this prospectus constitute “forwarding-looking statements” within
the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities and Exchange Act of 1995 (collectively, the
“Reform Act”). Certain, but not necessarily all, of such forward-looking
statements can be identified by the use of forward-looking terminology such
as
“believes,” “expects,” “may,” “will,” “should,” or “anticipates” or the negative
thereof or other variations thereon or comparable terminology, or by discussions
of strategy that involve risks and uncertainties. All statements other than
statements of historical fact, included in this prospectus regarding our
financial position, business strategy and plans or objectives for future
operations are forward-looking statements. Without limiting the broader
description of forward-looking statements above, we specifically note that
statements regarding potential drugs, their potential therapeutic effect, the
possibility of obtaining regulatory approval, our ability to manufacture and
sell any products, market acceptance or our ability to earn a profit from sales
or licenses of any drugs or our ability to discover new drugs in the future
are
all forward-looking in nature.
Such
forward-looking statements involve known and unknown risks, uncertainties and
other factors, including but not limited to, the risk factors discussed above,
which may cause the actual results, performance or achievements of Hemispherx
and its subsidiaries to be materially different from any future results,
performance or achievements expressed or implied by such forward-looking
statements and other factors referenced in this prospectus. We do not undertake
and specifically decline any obligation to publicly release the results of
any
revisions which may be made to any forward-looking statement to reflect events
or circumstances after the date of such statements or to reflect the occurrence
of anticipated or unanticipated events.
RATIO
OF EARNINGS TO FIXED CHARGES
We
have
incurred $17.1 million in fixed charges in the past five years. Fixed charges
mainly represent interest expensed as well as amortized discounts related to
indebtedness. We have incurred losses totaling $15.2 million, $20.9 million,
$12.4 million, $19.4 million and $18.1 million for the years ended December
31,
2003, 2004, 2005, 2006 and 2007, respectively. Until we achieve profitability,
we will not be able to cover our fixed charges from earnings.
USE
OF PROCEEDS
Except
as
otherwise provided in the applicable prospectus supplement, we intend to use
the
net proceeds from the sale of the securities offered by this prospectus for
general corporate purposes, which may include working capital, capital
expenditures, research and development expenditures, regulatory affairs
expenditures, clinical trial expenditures, acquisitions of new technologies
and
investments, and the repayment, refinancing, redemption or repurchase of future
indebtedness or capital stock. Additional information on the use of net proceeds
from the sale of securities offered by this prospectus may be set forth in
the
prospectus supplement relating to that offering.
DESCRIPTION
OF CAPITAL STOCK
Our
authorized capital stock currently consists of 200,000,000 shares of common
stock, par value $0.001 per share, and 5,000,000 shares of preferred stock,
$0.01 par value per share.
The
following summary of certain provisions of our common and preferred stock does
not purport to be complete. You should refer to our Amended and Restated
Certificate of Incorporation, amendments thereto, and our By laws, as amended,
all of which are filed with the SEC. The summary below is also qualified by
provisions of applicable law.
Common
Stock
Holders
of common stock are entitled to one vote per share on matters on which our
stockholders vote. There are no cumulative voting rights. Holders of common
stock are entitled to receive dividends, if declared by our board of directors,
out of funds that we may legally use to pay dividends. If we liquidate or
dissolve, holders of common stock are entitled to share ratably in our assets
once our debts and any liquidation preference owed to any then-outstanding
preferred stockholders are paid. All shares of common stock that are outstanding
as of the date of this prospectus are fully-paid and
non-assessable.
Preferred
Stock
We
are
currently authorized to issue 5,000,000 shares of preferred stock, none of
which
are currently outstanding.
Our
board
of directors has the authority to designate any or all shares of preferred
stock
in one or more series and to fix the rights of each series. Prior to issuance
of
shares of each series, our Board of Directors will adopt resolutions and file
a
certificate of designation fixing for each series the designations, powers,
preferences, conversion and other rights, voting powers, qualifications,
limitations as to dividends, restrictions and terms and conditions of
redemption. The preferred stock will, when issued, be fully paid and
nonassessable and will not have, or be subject to, any preemptive or similar
rights.
If
we
sell preferred stock, the prospectus supplement relating to the series of
preferred stock offered by that supplement will describe the specific terms
of
those securities, including:
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1.
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the
title and stated value of that preferred
stock;
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2.
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the
number of shares of that preferred stock offered, the liquidation
preference per share and the offering price of that preferred
stock;
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3.
|
the
dividend rate(s), period(s) and/or payment date(s) or method(s) of
calculation thereof applicable to that preferred
stock;
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4.
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whether
dividends will be cumulative or non-cumulative and, if cumulative,
the
date from which dividends on that preferred stock will
accumulate;
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5.
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the
voting rights applicable to that preferred
stock;
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6.
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the
procedures for any auction and remarketing, if any, for that preferred
stock;
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7.
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the
provisions for a sinking fund, if any, for that preferred
stock;
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8.
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the
provisions for redemption, if applicable, of that preferred
stock;
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9.
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any
listing of that preferred stock on any securities
exchange;
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10.
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the
terms and conditions, if applicable, upon which that preferred stock
will
be convertible into shares of the Common Stock, including the conversion
price (or manner of calculation of the conversion price) and conversion
period;
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11.
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a
discussion of federal income tax considerations applicable to that
preferred stock;
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12.
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any
limitations on issuance of any series of preferred stock ranking
senior to
or on a parity with that series of preferred stock as to dividend
rights
and rights upon liquidation, dissolution or winding up of our affairs;
and
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13.
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any
other specific terms, preferences, rights, limitations or restrictions
of
that preferred stock.
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We
believe the power to issue preferred stock will provide our board of directors
with flexibility in connection with certain possible corporate transactions.
The
issuance of preferred stock, however, could adversely affect the voting power
of
holders of our common stock, restrict their rights to receive payment upon
liquidation, and have the effect of delaying, deferring, or preventing a change
in control.
Transfer
Agent and Registrar
The
transfer agent and registrar for our common stock is Continental Stock Transfer
& Trust Company.
DESCRIPTION
OF WARRANTS
The
following description of our warrants for the purchase of our common stock,
preferred stock and/or debt securities in this prospectus contains the general
terms and provisions of the warrants. The particular terms of any offering
of
warrants will be described in a prospectus supplement relating to such offering.
The statements below describing the warrants are subject to and qualified by
the
applicable provisions of our certificate of incorporation, bylaws and the
relevant provisions of the laws of the State of Delaware.
General
We
may
issue warrants for the purchase of our common stock, preferred stock and/or
debt
securities. We may issue warrants independently or together with any of our
securities, and warrants also may be attached to our securities or independent
of them. We may issue series of warrants under a separate warrant agreement
between us and a specified warrant agent described in the prospectus supplement.
The warrant agent will act solely as our agent in connection with the warrants
and will not assume any obligation or relationship of agency or trust for or
with any holders or beneficial owners of warrants.
Terms
A
prospectus supplement will describe the specific terms of any warrants that
we
issue or offer, including:
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the
title of the warrants;
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the
aggregate number of warrants;
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the
price or prices at which the warrants will be
issued;
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the
currencies in which the price or prices of the warrants may be
payable;
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the
designation, amount and terms of our capital stock or debt securities
purchasable upon exercise of the
warrants;
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the
designation and terms of our other securities, if any, that may be
issued
in connection with the warrants, and the number of warrants issued
with
each corresponding security;
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if
applicable, the date that the warrants and the securities purchasable
upon
exercise of the warrants will be separately
transferable;
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the
prices and currencies for which the securities purchasable upon exercise
of the warrants may be purchased;
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the
date that the warrants may first be
exercised;
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the
date that the warrants expire;
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the
minimum or maximum amount of warrants that may be exercised at any
one
time;
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information
with respect to book-entry procedures, if
any;
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a
discussion of certain federal income tax considerations;
and
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any
other material terms of the warrants, including terms, procedures
and
limitations relating to the exchange and exercise of the
warrants.
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Exercise
of Warrants
Each
warrant will entitle the holder to purchase for cash the principal amount of
debt securities or shares of preferred stock or common stock at the applicable
exercise price set forth in, or determined as described in, the applicable
prospectus supplement. Warrants may be exercised at any time up to the close
of
business on the expiration date set forth in the applicable prospectus
supplement. After the close of business on the expiration date, unexercised
warrants will become void.
Warrants
may be exercised by delivering to the corporation trust office of the warrant
agent or any other officer indicated in the applicable prospectus supplement
(a)
the warrant certificate properly completed and duly executed and (b) payment
of
the amount due upon exercise. As soon as practicable following exercise, we
will
forward the debt securities or shares of preferred stock or common stock
purchasable upon exercise. If less than all of the warrants represented by
a
warrant certificate are exercised, a new warrant certificate will be issued
for
the remaining warrants.
DESCRIPTION
OF DEBT SECURITIES
We
anticipate that any debt securities which we offer by this prospectus will
be
issued under an indenture between us and a trustee to be identified in the
prospectus supplement. If a proposed debt transaction is not exempt under the
Trust Indenture Act of 1939, as amended (the “Trust Indenture Act”), the terms
of the debt securities will include those stated in the indenture and those
made
part of the indenture by reference to the Trust Indenture Act, as in effect
on
the date of the indenture. If a proposed transaction is exempt under the Trust
Indenture Act, we may not use an indenture (and, thus a trustee) or, if we
use
an indenture, it may not fully comply with the requirements of the Trust
Indenture Act. The following description summarizes only the material provisions
of the indenture. Accordingly, you should read the form of indenture, a copy
of
which has been filed as an exhibit to the registration statement of which this
prospectus forms a part, because it, and not this description, defines your
rights as holders of our debt securities. The following description also
provides general information that will be contained in any debt instrument
we
may use if we do not use an indenture. You should also read the applicable
prospectus supplement for additional information and the specific terms of
the
debt securities.
General
We
may,
at our option, issue debt securities in one or more series from time to time.
“Debt securities” may include senior debt, senior subordinated debt or
subordinated debt. The particular terms of the debt securities offered by any
prospectus supplement, and the extent, if any, to which such general provisions
do not apply to the debt securities will be described in the prospectus
supplement relating to such debt securities. The following summaries set forth
certain general terms and provisions of the indenture and the debt securities.
The prospectus supplement relating to a series of debt securities being offered
will contain the following terms, if applicable:
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the
aggregate principal amount and any limit on such
amount;
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the
price at which such debt securities will be
issued;
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the
date on which the debt securities
mature;
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the
fixed or variable rate at which the debt securities will bear interest,
or
the method by which such rate shall be
determined;
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the
timing, place and manner of making principal, interest and any premium
payments on the debt securities, and, if applicable, where such debt
securities may be surrendered for registration of transfer or
exchange;
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the
date or dates, if any, after which the debt securities may be converted
or
exchanged into or for shares of our common stock, preferred stock
or
another company’s securities or properties or cash and the terms of any
such conversion or exchange;
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any
redemption or early repayment
provisions;
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any
sinking fund or similar provisions;
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the
authorized denominations;
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any
applicable subordination
provisions;
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any
guarantees of such securities by our subsidiaries or
others;
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the
currency in which we will pay the principal, interest and any premium
payments on such debt securities;
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whether
the amount of payments of principal of (and premium, if any) or interest,
if any, on the debt securities may be determined with reference to
an
index, formula or other method and the manner in which such amounts
shall
be determined;
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the
time period within which, the manner in which and the terms and conditions
upon which the purchaser of the securities can select the payment
currency;
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the
provisions, if any, granting special rights to the holders of debt
securities upon certain events;
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any
additions to or changes in the events of default or covenants of
Hemispherx with respect to the debt securities and any change in
the right
of the trustee or the holders to declare the principal, premium and
interest with respect to such securities to be due and
payable;
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whether
and under what circumstances we will pay any additional amounts on
such
debt securities for any tax, assessment or governmental charge and,
if so,
whether we will have the option to redeem such debt securities instead
of
paying such amounts;
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the
form (registered and/or bearer securities), any restrictions applicable
to
the offer, sale or delivery of bearer securities and the terms, if
any,
upon which bearer securities may be exchanged for registered securities
and vice versa;
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the
date of any bearer securities or any global security, if other than
the
date of original issuance of the first security of the series to
be
issued;
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the
person to whom and manner in which any interest shall be
payable;
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whether
such securities will be issued in whole or in part in the form of
one or
more global securities;
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the
identity of the depositary for global
securities;
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whether
a temporary security is to be issued with respect to such series
and
whether any interest payable prior to the issuance of definitive
securities of the series will be credited to the account of the persons
entitled thereto;
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the
terms upon which beneficial interests in a temporary global security
may
be exchanged in whole or in part for beneficial interests in a definitive
global security or for individual definitive securities and the terms
upon
which such exchanges may be made;
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the
securities exchange(s), if any, on which the securities will be
listed;
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whether
any underwriter(s) will act as market maker(s) for the
securities;
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the
form (certificated or book-entry);
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the
form and/or terms of certificates, documents or conditions which
may be
necessary, if any, for the debt securities to be issuable in final
form;
and
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additional
terms not inconsistent with the provisions of the
indenture.
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One
or
more series of debt securities may be sold at a substantial discount below
their
stated principal amount bearing no interest or interest at a rate below the
market rate at the time of issuance. One or more series of debt securities
may
be variable rate debt securities that may be exchanged for fixed rate debt
securities. In such cases, all material United States federal income tax and
other considerations applicable to any such series will be described in the
applicable prospectus supplement. You should consult with your own tax advisor
before making a decision to purchase any debt security.
We
will
comply with Section 14(e) under the Exchange Act, to the extent applicable,
and
any other tender offer rules under the Exchange Act, which may then be
applicable, in connection with any obligation of Hemispherx to purchase debt
securities at the option of the holders thereof. Any such obligation applicable
to a series of debt securities will be described in the applicable prospectus
supplement.
Exchange,
Registration, Transfer and Payment
We
expect
payment of principal, premium, if any, and any interest on the debt securities
to be payable, and the exchange and the transfer of debt securities will be
registrable, at the office of the trustee or at any other office or agency
we
maintain for such purpose. We expect to issue debt securities in denominations
of U.S. $1,000 or integral multiples thereof. No service charge will be made
for
any registration of transfer or exchange of the debt securities, but we may
require a payment to cover any tax or other governmental charges payable in
connection therewith.
Global
Debt Securities
Unless
we
indicate otherwise in the applicable prospectus supplement, the following
provisions will apply to all debt securities.
The
debt
securities of a series may be issued in whole or in part in the form of one
or
more global securities that will be deposited with a depositary that we will
identify in a prospectus supplement. Each global security will be deposited
with
the depositary and will bear a legend regarding any related restrictions or
other matters as may be provided for pursuant to the applicable
indenture.
Unless
a
prospectus supplement states otherwise, no global security may be transferred
to, or registered or exchanged for debt securities registered in the name of,
any person or entity other than the depositary, unless:
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the
depositary has notified us that it is unwilling or unable or is no
longer
qualified to continue as
depositary;
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we
order the trustee that such global security shall be so transferable,
registrable and exchangeable, and such transfers shall be registrable;
or
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other
circumstances, if any, as may be described in the applicable prospectus
supplement.
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All
debt
securities issued in exchange for a global security or any portion thereof
will
be registered in such names as the depositary may direct. The specific terms
of
the depositary arrangement with respect to any portion of a series of debt
securities to be represented by a global security will be described in the
applicable prospectus supplement.
Debt
securities which are to be represented by a global security to be deposited
with
or on behalf of a depositary will be represented by a global security registered
in the name of such depositary or its nominee. Upon the issuance of such global
security, and the deposit of such global security with the depositary, the
depositary will credit, on its book-entry registration and transfer system,
the
respective principal amounts of the debt securities represented by such global
security to the accounts of institutions that have accounts with such depositary
or its nominee (the “Participants”). The accounts to be credited will be
designated by the underwriters or agents of such debt securities or by us,
if
such debt securities are offered and sold directly by us.
Ownership
of beneficial interests in such global security will be limited to Participants
or persons that may hold interests through Participants. Ownership of beneficial
interests in such global security will be shown on, and the transfer of that
ownership interest will be effected only through, records maintained by the
depositary or its nominee for such global security or by Participants or persons
that hold through Participants.
The
laws
of some jurisdictions require that certain purchasers of securities take
physical delivery of such securities in certificated form. The foregoing
limitations and such laws may impair the ability to transfer beneficial
interests in such global securities.
So
long
as the depositary, or its nominee, is the registered owner of such global
security, such depositary or such nominee, as the case may be, will be
considered the sole owner or holder of the debt securities represented by such
global security for all purposes under the indenture. Payment of principal
of,
and premium and interest, if any, on debt securities will be made to the
depositary or its nominee as the registered owner or bearer as the case may
be
of the global security representing such debt securities. Each person owning
a
beneficial interest in such global security must rely on the procedures of
the
depositary and, if such person is not a Participant, on the procedures of the
Participant through which such person owns its interest, to exercise any rights
of a holder under the indenture. If we request any action of holders or if
an
owner of a beneficial interest in such global security desires to give any
notice or take any action a holder is entitled to give or take under the
indenture, the depositary will authorize the Participants to give such notice
or
take such action, and Participants would authorize beneficial owners owning
through such Participants to give such notice or take such action or would
otherwise act upon the instructions of beneficial owners owning through
them.
The
rights of any holder of a debt security to receive payment of principal and
premium of, if any, and interest on such debt security, on or after the
respective due dates expressed or provided for in such debt security, or to
institute suit for the enforcement of any such payment on or after such
respective dates, shall not be impaired or affected without the consent of
the
holders.
Neither
we, the trustee, any paying agent nor the security registrar for such debt
securities will have any responsibility or liability for any aspect of the
records relating to or payments made on account of beneficial ownership
interests of the global security for such debt securities or for maintaining,
supervising or receiving any records relating to such beneficial ownership
interests.
We
expect
that the depositary or its nominee, upon receipt of any payment of principal,
premium or interest, will credit immediately Participants’ accounts with
payments in amounts proportionate to their respective beneficial interests
in
the principal amount of the global security for such debt securities as shown
on
the records of such depositary or its nominee. We also expect that payments
by
Participants to owners of beneficial interests in such global security held
through such Participants will be governed by standing instructions and
customary practices, as is now the case with securities held for the accounts
of
customers in bearer form or registered in “street name,” and will be the
responsibility of such Participants.
If
the
depositary for a global security representing debt securities of a particular
series is at any time unwilling or unable to continue as depositary and we
do
not appoint a successor depositary within 90 days, we will issue debt securities
of such series in definitive form in exchange for such global security. In
addition, we may at any time and in our sole discretion determine not to have
the debt securities of a particular series represented by one or more global
securities and, in such event, will issue debt securities of such series in
definitive form in exchange for all of the global securities representing debt
securities of such series.
Covenants
Except
as
permitted under “Consolidation, Merger and Sale of Assets,” the indenture will
require us to do or cause to be done all things necessary to preserve and keep
in full force and effect our existence and rights (declaration and statutory);
provided, however, that we shall not be required to preserve any right if we
determine that the preservation thereof is no longer desirable in the conduct
of
our business and that the loss thereof is not disadvantageous in any material
respect to the holders of the debt securities.
The
indenture will require us to pay or discharge or cause to be paid or discharged,
before the same shall become delinquent, all taxes, assessments and governmental
charges levied or imposed upon us except any tax, assessment, charge or claim
whose amount or applicability is being contested in good faith.
Reference
is made to the indenture and applicable prospectus supplement for information
with respect to any additional covenants specific to a particular series of
debt
securities.
Consolidation,
Merger and Sale of Assets
Except
as
set forth in the applicable prospectus supplement, the indenture will provide
that we shall not consolidate with, or sell, assign, transfer, lease or convey
all or substantially all of our assets, or merge into, to any person
unless:
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we
are the surviving entity or, in the event that we are not the surviving
entity, the entity formed by the transaction (in a consolidation)
or the
entity which received the transfer of assets is a corporation organized
under the laws of any state of the United States or the District
of
Columbia;
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such
entity assumes all of our obligations under the debt securities and
the
indenture; and
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immediately
after giving effect to the transaction, no event of default, as defined
in
the indenture, shall have occurred and be
continuing.
|
Notwithstanding
the foregoing, we may merge with another person or acquire by purchase or
otherwise all or any part of the property or assets of any other corporation
or
person in a transaction in which we are the surviving entity.
Events
of Default
Unless
otherwise specified in the applicable prospectus supplement, the following
are
events of default with respect to any series of debt securities issued under
the
indenture:
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failure
to pay principal of any debt security of that series when due and
payable
at maturity, upon acceleration, redemption or
otherwise;
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failure
to pay any interest on any debt security of that series when due,
and the
default continues for 30 days;
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failure
to comply with any covenant or warranty contained in the indenture,
other
than covenants or warranties contained in the indenture solely for
the
benefit of other series of debt securities, and the default continues
for
30 days after notice from the trustee or the holders of at least
25% in
principal amount of the then outstanding debt securities of that
series;
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certain
events of bankruptcy, insolvency or reorganization;
and
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any
other event of default provided with respect to that particular series
of
debt securities.
|
If
an
event of default occurs and continues, then upon written notice to us the
trustee or the holders of at least 25% in principal amount of the outstanding
debt securities of that series may declare the unpaid principal amount of,
and
any accrued and unpaid interest on, all debt securities of that series to be
due
and payable immediately. However, at any time after a declaration of
acceleration with respect to debt securities of any series has been made, the
holders of a majority in principal amount of the outstanding debt securities
of
that series may rescind and annul such acceleration:
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if
all events of default other than the nonpayment of principal of or
interest on the debt securities of that series which have become
due
solely because of the acceleration have been waived or cured;
and
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the
rescission would not conflict with any judgment or decree of a court
of
competent jurisdiction. For information as to waiver of defaults,
see
“Amendment, Supplement and Waiver”
below.
|
The
indenture will provide that, subject to the duty of the trustee during an event
of default to act with the required standard of care, the trustee will be under
no obligation to exercise any of its rights or powers under the indenture at
the
request or direction of any of the holders, unless such holders shall have
offered to the trustee reasonable security or indemnity. Subject to certain
provisions, including those requiring security or indemnification of the
trustee, the holders of a majority in principal amount of the outstanding debt
securities of any series will have the right to direct the time, method and
place of conducting any proceeding for any remedy available to the trustee,
or
exercising any trust or power conferred on the trustee, with respect to the
debt
securities of that series.
We
will
be required to furnish to the trustee under the indenture annually a statement
as to the performance by us of our obligations under that indenture and as
to
any default in such performance.
Discharge
of Indenture and Defeasance
Except
as
otherwise set forth in the applicable prospectus supplement, we may terminate
our obligations under the debt securities of any series, and the corresponding
obligations under the indenture when:
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we
have paid or deposited with the trustee funds or United States government
obligations in an amount sufficient to pay at maturity all outstanding
debt securities of such series, including interest other than destroyed,
lost or stolen debt securities of such series which have not been
replaced
or paid;
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all
outstanding debt securities of such series have been delivered (other
than
destroyed, lost or stolen debt securities of such series which have
not
been replaced or paid) to the trustee for cancellation;
or
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all
outstanding debt securities of any series have become due and payable;
and
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we
have paid all other sums payable under the
indenture.
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In
addition, we may terminate substantially all our obligations under the debt
securities of any series and the corresponding obligations under the indenture
if:
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we
have paid or deposited with the trustee, in trust an amount of cash
or
United States government obligations sufficient to pay all outstanding
principal of and interest on the then outstanding debt securities
of such
series at maturity or upon their redemption, as the case may
be;
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such
deposit will not result in a breach of, or constitute a default under,
the
indenture;
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no
default or event of default shall have occurred and continue on the
date
of deposit and no event of default as a result of a bankruptcy or
event
which with the giving of notice or the lapse of time would become
a
bankruptcy event of default shall have occurred and be continuing
on the
91st day after such date;
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we
deliver to the trustee a legal opinion that we have received from,
or
there has been published by, the United States Internal Revenue Service
a
ruling, or there has been a change in tax law, in either case to
the
effect that the holders of the debt securities of such series will
not
recognize income, gain or loss for Federal income tax purposes as
a result
of our exercise of such option and shall be subject to Federal income
tax
on the same amounts and in the same manner and at the same times
as would
have been the case if such option had not been exercised;
and
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certain
other conditions are met.
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We
shall
be released from our obligations with respect to the covenants to deliver
reports required to be filed with the SEC and an annual compliance certificate,
and to make timely payments of taxes (including covenants described in a
prospectus supplement) and any event of default occurring because of a default
with respect to such covenants as they related to any series of debt securities
if:
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we
deposit or cause to be deposited with the trustee in trust an amount
of
cash or United States government obligations sufficient to pay and
discharge when due the entire unpaid principal of and interest on
all
outstanding debt securities of any
series;
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such
deposit will not result in a breach of, or constitute a default under,
the
indenture;
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no
default or event of default shall have occurred and be continuing
on the
date of deposit and no event of default as a result of a bankruptcy
or
event which with the giving of notice or the lapse of time would
become a
bankruptcy event of default shall have occurred and be continuing
on the
91st day after such date;
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we
deliver to the trustee a legal opinion that the holders of the debt
securities of such series will not recognize income, gain or loss
for
Federal income tax purposes as a result of our exercise of such option
and
shall be subject to Federal income tax on the same amounts and in
the same
manner and at the same times as would have been the case if such
option
had not been exercised; and
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certain
other conditions are met.
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Upon
satisfaction of such conditions, our obligations under the indenture with
respect to the debt securities of such series, other than with respect to the
covenants and events of default referred to above, shall remain in full force
and effect.
Notwithstanding
the foregoing, no discharge or defeasance described above shall affect the
following obligations to or rights of the holders of any series of debt
securities:
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rights
of registration of transfer and exchange of debt securities of such
series;
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rights
of substitution of mutilated, defaced, destroyed, lost or stolen
debt
securities of such series;
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rights
of holders of debt securities of such series to receive payments
of
principal thereof and premium, if any, and interest thereon when
due;
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rights,
obligations, duties and immunities of the
trustee;
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rights
of holders of debt securities of such series as beneficiaries with
respect
to property deposited with the trustee and payable to all or any
of them;
and
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our
obligations to maintain an office or agency in respect of the debt
securities of such series.
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Transfer
and Exchange
A
holder
of debt securities may transfer or exchange such debt securities in accordance
with the indenture. The registrar for the debt securities may require a holder,
among other things, to furnish appropriate endorsements and transfer documents,
and to pay any taxes and fees required by law or permitted by the indenture.
The
registrar is not required to transfer or exchange any debt security selected
for
redemption or any debt security for a period of 15 days before a selection
of
debt security to be redeemed.
The
registered holder of a debt security may be treated as the owner of such
security for all purposes.
Amendment,
Supplement and Waiver
Subject
to certain exceptions, the terms of the indenture or the debt securities may
be
amended or supplemented by us and the trustee with the written consent of the
holders of at least a majority in principal amount of the outstanding debt
securities of each series affected by the amendment with each series voting
as a
separate class. Without the consent of any holder of the debt securities, we
and
the trustee may amend the terms of the indenture or the debt securities
to:
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cure
any ambiguity, defect or
inconsistency;
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provide
for the assumption of our obligations to holders of the debt securities
by
a successor corporation;
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provide
for uncertificated debt securities in addition to certificated debt
securities;
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· |
make
any change that does not adversely affect the rights of any holder
of the
debt securities in any material respect;
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add
to, change or eliminate any other provisions of the indenture in
respect
of one or more series of debt securities if such change would not
(i)
apply to any security of any series created prior to the execution
of a
supplemental indenture and entitled to the benefit of such provision
and
(ii) modify the rights of the holder of any such security with respect
to
such provision or become effective only when there is no outstanding
security of any series created prior to the execution of such supplemental
indenture and entitled to such
benefits;
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establish
any additional series of debt securities;
or
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comply
with any requirement of the SEC in connection with the qualification
of
the indenture under the Trust Indenture
Act.
|
However,
holders of each series of debt securities affected by a modification must
consent to modifications that have the following effect:
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· |
reduce
the principal amount of debt securities the holders of which must
consent
to an amendment, supplement or waiver of any provision of the
indenture;
|
| |
·
|
reduce
the rate or change the time for payment of interest on any debt
security;
|
| |
·
|
reduce
the principal of or change the fixed maturity of any debt
securities;
|
| |
·
|
change
the date on which any debt security may be subject to redemption
or
repurchase, or reduce the redemption or repurchase price
therefor;
|
| |
·
|
make
any debt security payable in currency other than that stated in the
debt
security;
|
| |
·
|
waive
any existing default or event of default and the consequences with
respect
to that series;
|
| |
·
|
modify
the right of any holder to receive payment of principal or interest
on any
debt security on or after the respective due dates expressed or provided
for in the debt security;
|
| |
·
|
impair
the right of any holder to institute suit for the enforcement of
any
payment in or with respect to any such debt security;
or
|
| |
·
|
make
any change in the foregoing amendment provisions which require each
holder’s consent.
|
Any
existing default may be waived with the consent of the holders of at least
a
majority in principal amount of the then outstanding debt securities of the
series affected thereby.
The
consent of the holders of debt securities is not necessary to approve the
particular form of any proposed amendment to any indenture. It is sufficient
if
any consent approves the substance of the proposed amendment.
Replacement
Securities
Any
mutilated certificate representing a debt security or a certificate representing
a debt security with a mutilated coupon will be replaced by us at the expense
of
the holder upon surrender of such certificate to the trustee. Certificates
representing debt securities or coupons that become destroyed, stolen or lost
will be replaced by us at the expense of the holder upon delivery to us and
the
trustee of evidence of any destruction, loss or theft satisfactory to us and
the
trustee, provided that neither we nor the trustee has been notified that such
certificate or coupon has been acquired by a bona fide purchaser. In the case
of
any coupon which becomes destroyed, stolen or lost, such coupon will be replaced
by issuance of a new certificate representing the debt security in exchange
for
the certificate representing the debt security to which such coupon appertains.
In the case of a destroyed, lost or stolen certificate representing the debt
security or coupon, an indemnity bond satisfactory to the trustee and us may
be
required at the expense of the holder of such debt security before a replacement
certificate will be issued.
Regarding
the Trustee
We
will
identify in the prospectus supplement relating to any series of debt securities
the trustee with respect to such series. The indenture and provisions of the
Trust Indenture Act incorporated by reference therein contain certain
limitations on the rights of the trustee, should it become a creditor of
Hemispherx, to obtain payment of claims in certain cases, or to realize on
certain property received in respect of any such claim, as security or
otherwise. The trustee and its affiliates may engage in, and will be permitted
to continue to engage in, other transactions with us and our affiliates;
provided, however, that if it acquires any conflicting interest, as defined
in
the Trust Indenture Act, it must eliminate such conflict or resign.
The
holders of a majority in principal amount of the then outstanding debt
securities of any series will have the right to direct the time, method and
place of conducting any proceeding for exercising any remedy available to the
trustee. The Trust Indenture Act and the indenture provide that in case an
event
of default shall occur, and be continuing, the trustee will be required, in
the
exercise of its rights and powers, to use the degree of care and skill of a
prudent man in the conduct of his own affairs. Subject to such provision, the
trustee will be under no obligation to exercise any of its rights or powers
under the indenture at the request of any of the holders of the debt securities
issued thereunder, unless they have offered to the trustee indemnity
satisfactory to it.
Governing
Law
The
debt
securities will be governed by and construed in accordance with the laws of
the
State of New York.
PLAN
OF DISTRIBUTION
We
may
sell the securities registered under this prospectus:
| |
·
|
through
underwriting syndicates represented by one or more managing
underwriters;
|
| |
·
|
to
or through underwriters or dealers;
|
| |
·
|
directly
to one or more purchasers;
|
| |
·
|
through
a block trade in which the broker or dealer engaged to handle the
block
trade will attempt to sell the securities as agent, but may position
and
resell a portion of the block as principal to facilitate the transaction;
or
|
| |
·
|
through
a combination of any of these methods of
sale.
|
We
may,
from time to time, authorize underwriters acting as our agents to offer and
sell
the securities upon the terms and conditions as are set forth in the applicable
prospectus supplement. We will describe the name or names of any underwriters
and the purchase price of the securities in a prospectus supplement relating
to
the securities. Any underwritten offering may be on a best efforts or a firm
commitment basis. The obligations, if any, of the underwriter to purchase any
securities will be subject to certain conditions.
If
a
dealer is used in an offering of securities, we may sell the securities to
the
dealer as principal. We will describe the name or names of any dealers and
the
purchase price of the securities in a prospectus supplement relating to the
securities. The dealer may then resell the securities to the public at varying
prices to be determined by the dealer at the time of sale. Any public offering
price and any discounts or concessions allowed, re-allowed, or paid to dealers
may be changed from time to time and will be described in a prospectus
supplement relating to the securities.
We,
or
any underwriter, dealer or agent, may distribute the securities from time to
time in one or more transactions at:
| |
·
|
a
fixed price or prices, which may be
changed;
|
| |
·
|
at
market prices prevailing at the time of
sale;
|
| |
·
|
at
prices related to prevailing market prices;
or
|
Any
of
these prices may represent a discount from the prevailing market
prices.
To
the
extent permitted by and in accordance with Regulation M under the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), in connection with an
offering an underwriter may engage in over-allotments, stabilizing transactions,
short covering transactions and penalty bids. Over-allotments involve sales
in
excess of the offering size, which creates a short position. Stabilizing
transactions permit bids to purchase the underlying security so long as the
stabilizing bids do not exceed a specified maximum. Short covering transactions
involve purchases of the securities in the open market after the distribution
is
completed to cover short positions. Penalty bids permit the underwriters to
reclaim a selling concession from a dealer when the securities originally sold
by the dealer are purchased in a covering transaction to cover short positions.
Those activities may cause the price of the securities to be higher than it
would be otherwise. If commenced, the underwriters may discontinue any of these
activities at any time. We will describe any of these activities in the
prospectus supplement.
We
may
authorize underwriters, dealers or agents to solicit offers by certain
institutions to purchase our securities at the public offering price under
delayed delivery contracts. If we use delayed delivery contracts, we will
disclose that we are using them in the prospectus supplement and will tell
you
when we will demand payment and delivery of the securities under the delayed
delivery contracts. These delayed delivery contracts will be subject only to
the
conditions that we set forth in the prospectus supplement. We will indicate
in
our prospectus supplement the commission that underwriters and agents soliciting
purchases of our securities under delayed delivery contracts will be entitled
to
receive.
In
connection with the sale of the securities and as further set forth in an
applicable prospectus supplement, underwriters may receive compensation from
us
or from purchasers of the securities for whom they may act as agents, in the
form of discounts, concessions or commissions. Underwriters may sell the
securities to or through dealers, and these dealers may receive compensation
in
the form of discounts, concessions or commissions from the underwriters and/or
commissions from the purchasers for whom they may act as agents. Underwriters,
dealers and agents that participate in the distribution of the securities may
be
deemed to be underwriters, and any discounts or commissions they receive from
us, and any profit on the resale of the securities they realize, may be deemed
to be underwriting discounts and commissions under the Securities Act of 1933,
as amended (the “Securities Act”). The prospectus supplement will identify any
underwriter or agent and will describe any compensation they receive from
us.
Unless
otherwise specified in the prospectus supplement, each series of the securities
will be a new issue with no established trading market, other than our common
stock, which is currently listed on the American Stock Exchange. We will apply
to the American Stock Exchange to list any additional shares of common stock
that we offer and sell pursuant to a prospectus supplement. To the extent
permitted by and in accordance with Regulation M under the Exchange Act, any
underwriters who are qualified market makers on the American Stock Exchange
may
engage in passive market making transactions in the securities on the American
Stock Exchange during the business day prior to the pricing of an offering,
before the commencement of offers or sales of the securities. Passive market
makers must comply with applicable volume and price limitations and must be
identified as passive market makers. In general, a passive market maker must
display its bid at a price not in excess of the highest independent bid for
such
security; if all independent bids are lowered below the passive market maker’s
bid, however, the passive market maker’s bid must then be lowered when certain
purchase limits are exceeded. It is possible that one or more underwriters
may
make a market in our securities, but underwriters will not be obligated to
do so
and may discontinue any market making at any time without notice. Therefore,
we
can give no assurance about the liquidity of our securities that may be sold
pursuant to this prospectus.
Under
agreements we may enter into, we may indemnify underwriters, dealers and agents
who participate in the distribution of the securities against certain
liabilities, including liabilities under the Securities Act.
Certain
of the underwriters, dealers and agents and their affiliates may be customers
of, engage in transactions with, and perform services for us and our
subsidiaries from time to time in the ordinary course of business. Any such
relationships will be disclosed in an applicable prospectus
supplement.
If
indicated in the prospectus supplement, we will authorize underwriters or other
persons acting as our agents to solicit offers by institutions to purchase
securities from us pursuant to contracts providing for payment and delivery
on a
future date. Institutions with which we may make these contracts include
commercial and savings banks, insurance companies, pension funds, investment
companies, educational and charitable institutions and others. The obligations
of any purchaser under any such contract will be subject to the condition that
the purchase of the securities shall not at the time of delivery be prohibited
under the laws of the jurisdiction to which the purchaser is subject. The
underwriters and other agents will not have any responsibility with regard
to
the validity or performance of these contracts.
LEGAL
MATTERS
The
validity of the securities offered in this prospectus will be passed upon for
us
by Silverman Sclar Shin & Byrne PLLC, New York, New York.
EXPERTS
The
financial statements, the related financial statement schedule, and the
effectiveness of internal control over financial reporting incorporated by
reference in this Prospectus and Registration Statement have been audited by
McGladrey & Pullen, LLP, an independent registered public accounting firm,
as stated in their report incorporated herein by reference, and are incorporated
in reliance upon such report and upon the authority of such firm as experts
in
accounting and auditing.
The
financial statements and schedules as of December 31, 2005 and for the year
then
ended incorporated by reference in this Prospectus and in the Registration
Statement have been so incorporated in reliance on the report of BDO Seidman,
LLP, an independent registered public accounting firm, incorporated herein
by
reference and in the Registration Statement, given on the authority of said
firm
as experts in auditing and accounting.
WHERE
YOU CAN FIND MORE INFORMATION
This
prospectus is part of a registration statement on Form S-3 that we filed with
the SEC. This prospectus does not contain all of the information included in
the
registration statement. For further information about us and our securities,
you
should refer to the registration statement and the exhibits filed with the
registration statement.
We
are
subject to the information requirements of the Securities Exchange Act of 1934
and file annual, quarterly and current reports, proxy statements and other
information with the SEC. You can read our SEC filings, including the
registration statement, over the Internet at the SEC’s website at www.sec.gov
or
through our website at www.hemispherx.net.
Information contained on our website is not considered to be a part of, nor
incorporated by reference in, this prospectus. You may also read and copy any
document we file with the SEC at its Public Reference Room at 100 F Street,
NE,
Washington, D.C. 20549.
You
may
also obtain copies of the documents at prescribed rates by writing to the Public
Reference Room of the SEC at 100 F Street, NE, Washington, D.C. 20549. Please
call the SEC at 1-800-SEC-0330 for further information on the operation of
the
Public Reference Room.
INFORMATION
INCORPORATED BY REFERENCE
The
SEC
allows us to “incorporate by reference” the information that we file with them,
which means that we can disclose important information to you by referring you
to those documents. The information incorporated by reference is considered
to
be an important part of this prospectus, and later information that we file
with
the SEC will automatically update and supersede this information. We incorporate
by reference the following documents and any future filing made with the SEC
under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of
1934
prior to the termination of the offering:
|
(a)
|
Our
annual report on Form 10-K for our fiscal year ended December 31,
2007,
SEC
File No. 1-13441.
|
|
(b)
|
Our
quarterly report on Form 10-Q for the three months ended March 31,
2008,
SEC File No. 1-13441.
|
|
(c)
|
Our
current report on Form 8-K, SEC File No. 1-13441 filed with the SEC
on
March 10, 2008.
|
|
(d)
|
Our
proxy statement on schedule 14A for our 2007 annual meeting, SEC
File No. 1-13441.
|
|
(e)
|
A
description of our common stock contained in our registration statement
on
Form S-1, SEC File No. 333-117178, and any amendment or report filed
for
the purpose of updating this description filed subsequent to the
date of
this prospectus and prior to the termination of this
offering.
|
You
may
request a copy of these filings, at no cost, by writing or telephoning us at
the
following address: Hemispherx Biopharma, Inc., 1617 JFK Boulevard, Philadelphia,
Pennsylvania 19103, telephone number 215-988-0080.
You
should rely only on the information incorporated by reference or provided in
this prospectus or any supplement. We have not authorized anyone else to provide
you with different information. We will not make offers to sell these shares
in
any state where the offer is not permitted. You should not assume that the
information in this prospectus or any supplement is accurate as of any date
other that the date on the front of those documents.
HEMISPHERX
BIOPHARMA, INC.
$50,000,000
Common
Stock
Preferred
Stock
Warrants
Debt
Securities
PROSPECTUS
June
__,
2008
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
ITEM
14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
The
following table sets forth the costs and expenses payable by us in connection
with the preparation and filing of this registration statement. All amounts
are
estimates subject to future contingencies except the SEC registration statement
filing fee.
|
SEC
Filing Fees
|
|
$
|
1,950
|
|
|
American
Stock Exchange Listing Fee
|
|
$
|
30,000
|
|
|
Printing
and Engraving Expenses
|
|
$
|
2,000
|
|
|
Accounting
Fees and Expenses
|
|
$
|
20,000
|
|
|
Legal
Fees and Expenses
|
|
$
|
15,000
|
|
|
Transfer
Agent and Registrar Fees
|
|
$
|
1,000
|
|
|
Miscellaneous
|
|
$
|
1,000
|
|
|
Total
Expenses
|
|
$
|
70,965
|
|
ITEM
15. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
The
Registrant’s Amended and Restated Certificate of Incorporation provides that the
Registrant shall indemnify to the extent permitted by Delaware law any person
whom it may indemnify thereunder, including directors, officers, employees
and
agents of the Registrant. Such indemnification (other than an order by a court)
shall be made by the Registrant only upon a determination that indemnification
is proper in the circumstances because the individual met the applicable
standard of conduct. Advances for such indemnification may be made pending
such
determination. In addition, the Registrant's Amended and Restated Certificate
of
Incorporation eliminates, to the extent permitted by Delaware law, personal
liability of directors to the Registrant and its stockholders for monetary
damages for breach of fiduciary duty as directors.
The
Registrant's authority to indemnify its directors and officers is governed
by
the provisions of Section 145 of the Delaware General Corporation Law, as
follows:
|
(a)
|
A
corporation shall have the power to indemnify any person who was
or is a
party or is threatened to be made a party to any threatened, pending
or
completed action, suit or proceeding, whether civil, criminal,
administrative or investigative (other than action by or in the right
of
the corporation) by reason of the fact that he is or was a director,
officer, employee or agent of the corporation, or is or was serving
at the
request of the corporation as a director, officer, employee or agent
of
another corporation, partnership, joint venture, trust or other
enterprise, against expenses (including attorneys' fees), judgments,
fines
and amounts paid in settlement actually and reasonably incurred by
the
person in connection with such action, suit or proceeding if he acted
in
good faith and in a manner he reasonably believed to be in or not
opposed
to the best interests of the corporation, and, with respect to any
criminal action or proceeding, had no reasonable cause to believe
his
conduct was unlawful. The termination of any action, suit or proceeding
by
judgment, order, settlement, conviction, or upon a plea of nolo contendere
or its equivalent, shall not, of itself, create a presumption that
the
person did not act in good faith and in a manner which he reasonably
believed to be in or not opposed to the best interests of the corporation,
and, with respect to any criminal action or proceeding, had reasonable
cause to believe that the person's conduct was
unlawful.
|
|
(b)
|
A
corporation shall have the power to indemnify any person who was
or is a
party or is threatened to be made a party to any threatened, pending
or
completed action or suit by or in the right of the corporation to
procure
a judgment in its favor by reason of the fact that he is or was a
director, officer, employee or agent of the corporation, or is or
was
serving at the request of the corporation as a director, officer,
employee
or agent of another corporation, partnership, joint venture, trust
or
other enterprise against expenses (including attorneys' fees) actually
and
reasonably incurred by the person in connection with the defense
or
settlement of such action or suit if he acted in good faith and in
a
manner he reasonably believed to be in or not opposed to the best
interests of the corporation and except that no indemnification shall
be
made in respect of any claim, issue or matter as to which such person
shall have been adjudged to be liable to the corporation unless and
only
to the extent that the Court of Chancery or the court in which such
action
or suit was brought shall determine upon application that, despite
the
adjudication of liability but in view of all the circumstances of
the
case, such person is fairly and reasonably entitled to indemnity
for such
expenses which the Court of Chancery or such other court shall deem
proper.
|
|
(c)
|
To
the extent that a present or former director or officer of a corporation
has been successful on the merits or otherwise in defense of any
action,
suit or proceeding referred to in subsections (a) and (b) of this
section,
or in defense of any claim, issue or matter therein, such person
shall be
indemnified against expenses (including attorneys' fees) actually
and
reasonably incurred by such person in connection
therewith.
|
|
(d)
|
Any
indemnification under subsections (a) and (b) of this section (unless
ordered by a court) shall be made by the corporation only as authorized
in
the specific case upon a determination that indemnification of the
present
or former director, officer, employee or agent is proper in the
circumstances because he has met the applicable standard of conduct
set
forth in subsections (a) and (b) of this section. Such determination
shall
be made, with respect to a person who is a director or officer at
the time
of such determination (1) by a majority vote of the directors who
are not
parties to such action, suit or proceeding, even though less than
a
quorum, or (2) by a committee of such directors designated by majority
vote of such directors, even though less than a quorum, or (3) if
there
are no such directors, or if such directors so direct, by independent
legal counsel in a written opinion, or (4) by the
stockholders.
|
|
(e)
|
Expenses
(including attorneys' fees) incurred by an officer or director in
defending a civil or criminal action, suit or proceeding may be paid
by
the corporation in advance of the final disposition or such action,
suit
or proceeding upon receipt of an undertaking by or on behalf of such
director or officer to repay such amount if it shall ultimately be
determined that such person is not entitled to be indemnified by
the
corporation as authorized in this section. Such expenses incurred
by
former directors and officers and other employees and agents may
be so
paid upon such terms and conditions, if any, as the corporation deems
appropriate.
|
|
(f)
|
The
indemnification and advancement of expenses provided by, or granted
pursuant to, the other subsections of this section shall not be deemed
exclusive of any other rights to which those seeking indemnification
or
advancement of expenses may be entitled under any by, agreement,
vote of
stockholders or disinterested directors or otherwise, both as to
action in
such person's official capacity and as to action in another capacity
while
holding such office.
|
|
(g)
|
A
corporation shall have power to purchase and maintain insurance on
behalf
of any person who is or was a director, officer, employee or agent
of the
corporation, or is or was serving at the request of the corporation
as a
director, officer, employee or agent of another corporation, partnership,
joint venture, trust or other enterprise against any liability asserted
against such person and incurred by such person in any such capacity,
or
arising out of his status as such, whether or not the corporation
would
have the power to indemnify such person against such liability under
this
section.
|
|
(h)
|
For
purposes of this section, references to the "corporation" shall include,
in addition to the resulting corporation, any constituent corporation
(including any constituent of a constituent) absorbed in a consolidation
or merger which, if its separate existence had continued, would have
had
the power and authority to indemnify its directors, officers, and
employees or agents, so that any person who is or was a director,
officer,
employee or agent of such constituent corporation, or is or was serving
at
the request of such constituent corporation as a director, officer,
employee or agent of another corporation, partnership, joint venture,
trust or other enterprise, shall stand in the same position under
this
section with respect to the resulting or surviving corporation as
such
person would have with respect to such constituent corporation if
its
separate existence had continued.
|
|
(i)
|
For
purposes of this section, references to "other enterprises" shall
include
employee benefit plans, references to "fines" shall include any excise
taxes assessed on a person with respect to any employee benefit plan,
and
references to "serving at the request of the corporation" shall include
any service as a director, officer, employee, or agent with respect
to any
employee benefit plan, its participants or beneficiaries, and a person
who
acted in good faith and in a manner such person reasonably believed
to be
in the interest of the participants and beneficiaries of any employee
benefit plan shall be deemed to have acted in a manner "not opposed
to the
best interests of the corporation" as referred to in this
section.
|
|
(j)
|
The
indemnification and advancement of expenses provided by, or granted
pursuant to, this section shall, unless otherwise provided when authorized
or ratified, continue as to a person who has ceased to be a director,
officer, employee or agent and shall inure to the benefit of the
heirs,
executors and administrators of such a person.
|
|
(k)
|
The
Court of Chancery is hereby vested with exclusive jurisdiction to
hear and
determine all actions for advancement of expenses or indemnification
brought under this section, or under any bylaw, agreement, vote of
stockholders or disinterested directors, or otherwise. The
Court of Chancery may summarily determine a corporation's obligation
to
advance expenses (including attorneys'
fees).
|
ITEM
16. EXHIBITS.
|
Exhibit No.
|
|
Description
|
| |
|
|
|
1.1
|
|
Form
of Underwriting Agreement. (1)
|
| |
|
|
|
4.1
|
|
Specimen
certificate representing our Common Stock.(2)
|
|
4.2
|
|
Form
of Warrant. (1)
|
|
4.3
|
|
Form
of Indenture.
|
|
4.4
|
|
Rights
Agreement, dated as of November 19, 2002, between the Company and
Continental Stock Transfer & Trust Company. The Right Agreement
includes the Form of Certificate of Designation, Preferences and
Rights of
the Series A Junior Participating Preferred Stock, the Form of Rights
Certificate and the Summary of the Right to Purchase Preferred
Stock.(3)
|
| |
|
|
|
5.1
|
|
Opinion
of Silverman Sclar Shin & Byrne PLLC, legal
counsel.
|
| |
|
|
|
23.1
|
|
Consent
of McGladrey & Pullen, LLP
|
|
23.2
|
|
Consent
of BDO Seidman, LLP.
|
| |
|
|
|
23.3
|
|
Consent
of Silverman Sclar Shin & Byrne PLLC, legal counsel (included in
Exhibit 5.1).
|
| |
|
|
|
24.1
|
|
Powers
of Attorney (included on Signature Pages to this Registration
Statement.
|
| |
|
|
|
25.1
|
|
Statement
of Eligibility of Trustee on Form T-1.
(1)
|
|
(1)
|
To
be filed either by amendment or incorporated herein by reference
in
connection with the offering of specific
securities.
|
|
(2)
|
Filed
with the Securities and Exchange Commission as an exhibit to the
Company's
Registration Statement on Form S-1 (Registration No. 33-93314) declared
effective by the Securities and Exchange Commission on November 2,
1995.
|
|
(3)
|
Filed
with the Securities and Exchange Commission on November 20, 2002
as an
exhibit to the Company’s Registration Statement on Form 8-A (No. 0-27072)
and is hereby incorporated by
reference.
|
ITEM
17. UNDERTAKINGS
(a)
The
undersigned registrant hereby undertakes:
(1)
To
file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement:
i.
To
include any prospectus required by Section 10(a)(3) of the Securities Act
of 1933;
ii.
To
reflect in the prospectus any facts or events arising after the effective date
of the registration statement (or the most recent post-effective amendment
thereof) which, individually or in the aggregate, represent a fundamental change
in the information set forth in the registration statement. Notwithstanding
the
foregoing, any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the estimated maximum
offering range may be reflected in the form of prospectus filed with the
Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume
and price represent no more than 20 percent change in the maximum aggregate
offering price set forth in the “Calculation of Registration Fee” table in the
effective registration statement.
iii.
To
include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to
such information in the registration statement.
Provided
however, that Paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) of this section
do not apply if the registration statement is on Form S-3 or Form F-3 and the
information required to be included in a post-effective amendment by those
paragraphs is contained in reports filed with or furnished to the Commission
by
the registrant pursuant to section 13 or section 15(d) of the Securities
Exchange Act of 1934 that are incorporated by reference in the registration
statement, or is contained in a form of prospectus filed pursuant to Rule 424(b)
that is part of the registration statement.
(2)
That,
for the purpose of determining any liability under the Securities Act of 1933,
each such post-effective amendment shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona
fide
offering
thereof.
(3)
To
remove from registration by means of a post-effective amendment any of the
securities being registered which remain unsold at the termination of the
offering.
(4)
That,
for the purpose of determining liability under the Securities Act of 1933 to
any
purchaser:
i.
If the
registrant is relying on Rule 430B:
(A)
Each
prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed
to
be part of the registration statement as of the date the filed prospectus was
deemed part of and included in the registration statement; and
(B)
Each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7)
as
part of a registration statement in reliance on Rule 430B relating to an
offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose
of providing the information required by section 10(a) of the Securities Act
of
1933 shall be deemed to be part of and included in the registration statement
as
of the earlier of the date such form of prospectus is first used after
effectiveness or the date of the first contract of sale of securities in the
offering described in the prospectus. As provided in Rule 430B, for liability
purposes of the issuer and any person that is at that date an underwriter,
such
date shall be deemed to be a new effective date of the registration statement
relating to the securities in the registration statement to which that
prospectus relates, and the offering of such securities at that time shall
be
deemed to be the initial bona fide offering thereof. Provided, however, that
no
statement made in a registration statement or prospectus that is part of the
registration statement or made in a document incorporated or deemed incorporated
by reference into the registration statement or prospectus that is part of
the
registration statement will, as to a purchaser with a time of contract of sale
prior to such effective date, supersede or modify any statement that was made
in
the registration statement or prospectus that was part of the registration
statement or made in any such document immediately prior to such effective
date;
or
ii.
If
the registrant is subject to Rule 430C, each prospectus filed pursuant to Rule
424(b) as part of a registration statement relating to an offering, other than
registration statements relying on Rule 430B or other than prospectuses filed
in
reliance on Rule 430A, shall be deemed to be part of and included in the
registration statement as of the date it is first used after effectiveness.
Provided, however, that no statement made in a registration statement or
prospectus that is part of the registration statement or made in a document
incorporated or deemed incorporated by reference into the registration statement
or prospectus that is part of the registration statement will, as to a purchaser
with a time of contract of sale prior to such first use, supersede or modify
any
statement that was made in the registration statement or prospectus that was
part of the registration statement or made in any such document immediately
prior to such date of first use.
(5)
That,
for the purpose of determining liability of the registrant under the Securities
Act of 1933 to any purchaser in the initial distribution of the securities:
The
undersigned registrant undertakes that in a primary offering of securities
of
the undersigned registrant pursuant to this registration statement, regardless
of the underwriting method used to sell the securities to the purchaser, if
the
securities are offered or sold to such purchaser by means of any of the
following communications, the undersigned registrant will be a seller to the
purchaser and will be considered to offer or sell such securities to such
purchaser:
i.
Any
preliminary prospectus or prospectus of the undersigned registrant relating
to
the offering required to be filed pursuant to Rule 424;
ii.
Any
free writing prospectus relating to the offering prepared by or on behalf of
the
undersigned registrant or used or referred to by the undersigned registrant;
iii.
The
portion of any other free writing prospectus relating to the offering containing
material information about the undersigned registrant or its securities provided
by or on behalf of the undersigned registrant; and
iv.
Any
other communication that is an offer in the offering made by the undersigned
registrant to the purchaser.
(6)
To
file an application for the purpose of determining the eligibility of the
trustee to act under subsection (a) of Section 310 of the Trust Indenture Act
in
accordance with the rules and regulation s prescribed by the SEC under Section
305(b)(2) of the Trust Indenture Act.
(b)
The
undersigned registrant hereby undertakes that, for purposes of determining
any
liability under the Securities Act of 1933, each filing of the registrant’s
annual report pursuant to section 13(a) or section 15(d) of the Securities
Exchange Act of 1934 (and, where applicable, each filing of an employee benefit
plan’s annual report pursuant to section 15(d) of the Securities Exchange Act of
1934) that is incorporated by reference in the registration statement shall
be
deemed to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to
be
the initial bona fide offering thereof.
(c)
Insofar as indemnification for liabilities arising under the Securities Act
of
1933 may be permitted to directors, officers and controlling persons of the
registrant pursuant to the foregoing provisions, or otherwise, the registrant
has been advised that in the opinion of the Securities and Exchange Commission
such indemnification is against public policy as expressed in the Act and is,
therefore, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the registrant of expenses incurred
or paid by a director, officer or controlling person of the registrant in the
successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, the registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Act and will be governed by the final adjudication
of
such issue.
SIGNATURES
Pursuant
to the requirement of the Securities Act of 1933, this Registrant certifies
that
it has reasonable grounds to believe that it meets all of the requirements
for
filing on Form S-3 and has duly caused this registration statement to be signed
on its behalf by the undersigned, thereunto duly authorized in the City of
Philadelphia, Commonwealth of Pennsylvania, on the 12th day of June, 2008.
|
HEMISPHERX
BIOPHARMA, INC.
|
|
(Registrant)
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| |
|
|
By:
|
/s/
William A. Carter
|
| |
William
A. Carter, M.D.,
|
| |
Chief
Executive Officer
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POWER
OF ATTORNEY
KNOW
ALL
MEN BY THESE PRESENTS, that each person whose signature appears below
constitutes and appoints William A. Carter his true and lawful attorney-in-fact
and agent with full power of substitution and re-substitution, for him and
in
his name, place and stead, in any and all capacities to sign any or all
amendments (including, without limitation, post-effective amendments) to this
Registration Statement, any related Registration Statement filed pursuant to
Rule 462(b) under the Securities Act of 1933 and any or all pre- or
post-effective amendments thereto, and to file the same, with all exhibits
thereto, and all other documents in connection therewith, with the Securities
and Exchange Commission, granting unto said attorney-in-fact and agent, full
power and authority to do and perform each and every act and thing requisite
and
necessary to be done in and about the premises, as fully for all intents and
purposes as he might or could do in person, hereby ratifying and confirming
that
said attorney-in-fact and agent, or any substitute or substitutes for him,
may
lawfully do or cause to be done by virtue hereof.
Pursuant
to the requirements of the Securities Act of 1933, this registration statement
on Form S-3 has been signed by the following persons in the capacities indicated
on the dates indicated.
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Signature
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Title
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Date
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| |
|
|
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/s/
William A. Carter
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Chairman
of the Board, Chief Executive
|
|
|
|
William
A. Carter, M.D.
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|
Officer
(Principal Executive) and Director
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|
June 11, 2008
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| |
|
|
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|
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/s/Richard
C. Piani
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|
Director
|
|
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Richard
C. Piani
|
|
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|
June 11, 2008
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| |
|
|
|
|
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/s/
Robert E. Peterson
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|
Chief
Financial Officer and Chief
|
|
|
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Robert
E. Peterson
|
|
Accounting
Officer
|
|
June 11, 2008
|
| |
|
|
|
|
|
/s/Ransom
W. Etheridge
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|
Secretary,
General Counsel And Director
|
|
|
|
Ransom
W. Etheridge
|
|
|
|
June 11, 2008
|
| |
|
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/s/William
M. Mitchell
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|
Director
|
|
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William
M. Mitchell, M.D., Ph.D.
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|
|
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June 11, 2008
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| |
|
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/s/Iraj-Eqhbal
Kiani
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|
Director
|
|
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Iraj-Eqhbal
Kiani, Ph.D.
|
|
|
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June 11, 2008
|
Hemispherx
Biopharma, Inc.
Form
S-3
Index
to
Exhibits
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|
|
Description
|
| |
|
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4.3
|
|
Form
of Indenture.
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| |
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5.1
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Opinion
of Silverman Sclar Shin & Byrne PLLC, legal
counsel.
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23.1
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Consent
of McGladrey & Pullen, LLP, independent registered public accounting
firm.
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23.2
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Consent
of BDO Seidman, LLP, independent registered public accounting
firm.
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