SEC Company Response from PALISADE BIO, INC. (PALI) (CIK 0001357459) (PALI) — Jun 21, 2006
PALISADE BIO, INC. (PALI) (CIK 0001357459)
Date: June 21, 2006 · CIK: 0001357459 · Accession: 0001144204-06-025559
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File numbers found in text: 333-132923
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CORRESP
1
filename1.htm
Sonia
Barros
Division
of Corporation Finance
Telephone
Number: (202) 551-3655
Telecopier
Number: (202) 772-9217
Registration
Statement on Form SB-2, filed April 3, 2005 File No.
333-132923
Dear
Ms. Barros:
We
are submitting this letter in response to your comments of April 28, 2006,
along
with the Amended Form SB-2 for Neuralstem, Inc. This response will follow the
lineal order of your letter and each specific area addressed, utilizing the
text
of your letter as the primary guide:
Form
SB-2
Calculation
of Registration Fee
1.
Please
delete the reference to Rule 457(c). Rule 457(c) applies to exchange
traded securities or over-the-counter securities. The company's securities
are not currently traded on an exchange or
over-the-counter.
Response: We
have deleted the reference to rule 457(c) and updated the disclosure.
Prospectus
General
2.
As
there is currently no market for your common shares you must set
a price
at which the selling shareholders will offer the shares until a market
develops. Please revise your disclosure on the prospectus cover page
and
in the Plan of Distribution accordingly. Your revised disclosure
should
state that "The Selling shareholders will sell at a price of $x.xx
per
share until our shares are quoted on the OTC Bulletin Board and thereafter
at prevailing market prices or privately negotiated prices." In addition,
please also rcvise your calculation of the registration fee, to the
extent
applicable, to base your registration fee on your set
price
Response:
The company has recalculated the registration fee in compliance with Rule
457.
3.
We
note an article published in market wire on March 13, 2006 which
states
that Regal One's Chairman and CEO, Dr. Malcolm Currie, has agreed
to serve
on the company's board, Since Dr. Currie has been "chosen to become"
a
director, please revise your disclosure to provide the information
required by Item 401 of Regulation S-B as it relates to Dr.
Currie.
Response:
We
have revised our disclosure to provide the information required by Item 401
as
it relates to Dr. Currie.
1
4.
The
forepart of your prospectus uses jargon and technical terms. For
example,
these words and phrases appear in the forepart of your
prospectus:
"regenerative
medicine"
"billion
billion times (60 doublings or 1018)”
"controlled
differentiation"
"human
neurons and glia"
“optimize
its tissue acquisition"
"proof-of-principle
data"
"neurogenic
compounds"
Please
replace all technical language and jargon with language that can be understood
by persons who do not work in your industry. Alternately, if you cannot find
substitute language without changing the meaning, provide an explanation of
the
term where you first use it. See Rule 421(d)(2)(ii) of Regulation
C.
Response:
All
technical language has been deleted and substituted with wording to be
understood by a person who does not work in our industry.
5.
Please
revise your disclosure to provide a complete and consistent description
of
your current licenses. On page 5 you state that you have out-licensed
lead
compounds for further development toward various CNS diseases. On
page 22
you refer to compounds discovered under your program with the Department
of Defense that have been licensed out for development. Are the licenses
referenced on pages 5 and 22 the same? To whom have you licensed
these
compounds? On page 35 you mention a license agreement with an SA
company
substantially owned by one of your officers. In your description
of
business, please describe the material terms of each license, including,
but not limited to the parties to the license, the payment provisions,
the
existence of royalty provisions, exclusivity provisions,
obligations/rights to defend, and termination provisions. Please
also file
the license agreements as
exhibits.
Response:
We have clearly identified all licenses and have limited them to the section
entitled “Our Intellectual Property Licensed to Others.” We have also filed our
licensing agreements as exhibits.
6.
Please
revise your disclosure to provide a complete and consistent description
of
your grants. On page 22, you refer to a Department of Defense contact
that
was cancelled in 2002. On page 23, you state that your small molecule
program was funded by a grant from the Department of Defense. Is
this
grant the same as the contract you refer to on page 22? On page 33
you
refer to $310,000 in grant and other revenue for the drug development
program. From whom did you receive this grant revenue? Have you described
this grant in the prospectus? In your description of business, please
describe the material terms of each grant, including, but not limited
to
the aggregate amounts, stipulations and terms. Please also file any
relevant agreements as
exhibits.
Response:
We have clearly defined our one existing grant and included it in its own
section including any material terms thereof, entitled “Our Grants.” We have
also filed the grant as an exhibit.
2
Prospectus
Cover Page
7.
Please
limit the
cover page to the information that is required by Item 501 of Regulation
S-B. Your cover page contains superfluous information such as the
statement that the selling shareholders may be deemed underwriters,
who
will bear the expenses of the registration and the proceeds to be
received
from the exercise of warrants. You may describe this other information
in
the prospectus offering
summary.
Response:
The superfluous information has been removed from the Cover Page and the
information has been limited to that required by Item 501.
8.
In
addition, in the section of the prospectus that you choose to describe
who
will bear the expenses of the registration, please clarify the disclosure.
Your disclosure here contains inconsistent
statements. The statement in the last paragraph states that the company
will bear the expenses. The statement in the third paragraph states
that
Regal One Corporation will bear the
expenses.
Response:
We have updated the table regarding the expenses associated with the
registration statement expenses.
9. Further,
please clarify what you mean by "BDC,"
Response:
We have deleted all reference to BDC.
10.
Your
statement that a listing on the OTC BB "may occur" is inappropriate.
Please revise this
statement to explain that market makers may make listing applications
for
your stock once your registration statement becomes
effective.
Response:
Revised as suggested.
Recent
Developments,
11.
Please
revise the prospectus to describe the terms of the February and March
2006
private placements and to describe the material
terms of the related agreements and file the agreements as exhibits
to the
registration statement. We may have additional comments after we
have had
an opportunity to review
them.
Response:
We have deleted the recent development section as it is not required.
3
Risk
Factors. page 7
General
12.
Please
delete the statement "Our business is subject to various risks, included
but not limited to those described below." Your
risk factor section should describe all material
risks.
Response:
The sentence has been deleted.
13.
Please
revise each subheading to ensure it reflects the risk that
you
discuss in the text. Many of your subheadings currently merely state
a
fact about your business, such as "There is
no public market for the Company's securities" and "The Company needs
to
improve its financial control procedures." State in your subheadings
the
risks that result from the facts or
uncertainties.
Response:
The
subheadings have been revised to identify the specific risk clarified in the
text below the heading.
14.
We
note you have or plan to outsource the manufacturing of cGMP cells
for
your future ISP human clinical trials. Please add a risk factor that
addresses the risks relating to your reliance on such a
manufacturer.
Response:
We have added a disclosure regarding our risk relating to reliance on an
outsource manufacturer.
15.
We
note that you have 75,000,000 shares of authorized common stock
and
only 23,338,876 shares are currently issued and outstanding and you
have
assumed that only 33,468,876 shares will be issued and outstanding
after
the offering. Please also add a risk factor that addresses the risks
of
having such a large number of authorized but unissued common stock,
including the risks
that your management may issue additional stock without further
stockholder appioval, thereby causing dilution of current company
stockholders
Response: We
have added a disclosure the address the risk of having such a large amount
of
shares authorized but unissued.
16.
In
separate risk factors on pages 7 and 11 you indicate that you have
identified significant deficiencies and material weaknesses in your
internal controls over financial reporting. Please revise your disclosure
here or in
MD&A to elaborate on the nature of the significant deficiencies and
material weaknesses that you have
identified,
Response:
We have revised our disclosure contained in the risk factors to more full
identify the weaknesses we have identified.
Risks
Relating to the Corporation
17.
It
appears that you are addressing three separate risks in the first
risk
factor on page 7. The first
relates to the risks related to your limited operating history which
should be moved to the second risk factor that discusses your short
operating history. The second relates to the risks related to being
a
company in the preclinical stage of development. The third relates
to
the risks related to ethically sensitive and controversial issues.
Please
revise your disclosure to separate this risk factor accordingly with
appropriate subheadings for each risk
factor.
4
Response:
We have revised our risk factors with regard to the Company in their entirety
to
provide better disclosure.
18.
Please
revise the risk factor related to ethically sensitive and controversial
issues to describe the
nature of the ethically sensitive and controversial
issues.
Response:
We have eliminated the risk factor relating to ethical sensitivity as we do
not
feel it is a material risk at this early stage as we have no products.
The
Company has a short operating history.., page 7
19.
Please
revise this risk factor to disclose your net losses for the two most
recent fiscal years and any subsequent interim
periods.
Response:
We have removed the section describing our short operating history and included
a more detailed discussion in the section entitled: “Since the Company has a
limited operating history and has significantly shifted its operations and
strategies since inception, you cannot rely upon the Company’s limited
historical performance to make an investment decision. “
20.
Please
revise this risk factor to describe your limited sources of revenue.
Response:
Please see response to comment 19.
The
Company will require substantial additional funding....page
7
21.
Please
incorporate into this discussion the rate at which you are currently
burning cash on a monthly
basis.
Response:
The company has revised its disclosure to provide information with regard to
monthly burn rate.
22.
Please
revise to quantify and disclose your current anticipated needs for
additional financing.
Response:
We have revised our disclosure regarding anticipated needs for additional
financing. Please see response to common 21.
There
is no public market ... page 7
23.
Please
expand your discussion in this risk factor to explain that your stock
is
not traded on an exchange or on the OTCBB and that this is your initial
registration. Please also explain that even if it is listed on the
OTCBB,
the trading volume may be limited, making it difficult for an investor
to
sell shares.