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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

Date
April 3, 2005
Author
Not clearly detected
Form
CORRESP
Company
PALISADE BIO, INC. (PALI) (CIK 0001357459)

Letter

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.

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.

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 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.

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.

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

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.

Show Raw Text
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.