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SEC Company Response from Cardiff Oncology, Inc. (CRDF) (CIK 0001213037) (CRDF) — Jan 10, 2006

Cardiff Oncology, Inc. (CRDF) (CIK 0001213037)
Date: Jan. 10, 2006 · CIK: 0001213037 · Accession: 0001321543-06-000015

AI Filing Summary & Sentiment

File numbers found in text: 333-127071

Referenced dates: November 28, 2005, September 2, 2005

Date
August 1, 2005
Author
Not clearly detected
Form
CORRESP
Company
Cardiff Oncology, Inc. (CRDF) (CIK 0001213037)

Letter

Securities and Exchange Commission Division of Corporation Finance Attention: John Reynolds, Esq. Xenomics, Inc. Form SB-2 filed August 1, 2005 Amendment No. 1 to Form SB-2 filed October 28, 2005 File No. 333-127071

Re:

Dear Mr. Reynolds:

This letter sets forth the responses of Xenomics, Inc., a Florida corporation (the “Company” or “we”), to the comments received from the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated November 28, 2005 concerning the Company’s Registration Statement on Form SB-2 (File No. 333-127071) filed with the Commission on October 28, 2005 (the “Registration Statement”). We are authorized by the Company to provide the responses contained in this letter on behalf of the Company.

The numbers of the responses in this letter correspond to the numbers of the Staff’s comments as set forth in its letter to the Company dated November 28, 2005. References in the text of the responses herein to captions and page numbers are to Amendment No. 2 to Form SB-2 which is being filed herewith. For your convenience, we set forth each comment from your comment letter in bold typeface and include the Company’s response below it.

Table of Contents

1.

Please remove or relocate the boiler-plate paragraph following the table of contents.

We have removed the boiler plate paragraph following the table of contents in Amendment No. 2 to Form SB-2.

Prospectus Summary

2.

The background and development of both Used Kar Parts, Inc. and Xenomics Sub should be fully discussed pursuant to Item 101 of Regulation S-B.

On page 4 of Amendment No. 2 to Form SB-2 we have modified the Prospectus Summary to include the background and development of Used Kar Parts, Inc. and Xenomics Sub.

Risk Factors, page 6

3.

As noted in prior comment 10 to our letter dated September 2, 2005, several of your risk factors and subheadings are too broad and generic and should be revised to state the material risk that is specific to Xenomics, Inc. As a general rule, a risk factor is probably too generic if it is readily transferable to other offering documents or describes circumstances or factual situations that are equally applicable to other similarly situated businesses. Risk factors 10, 12, 14, 21, 27 and 28 should be revised, deleted or moved to another section of the prospectus.

On pages 5 to 11of Amendment No. 2 to Form SB-2 we have revised Risk Factors 10, 12, 14, 21, 26 and 27.

4.

The second risk factor does not appear material in view of the liquid assets of the company at the latest balance sheet date and the disclosure on page 16 that “we expect that existing capital resources will be sufficient for at least the next twelve months.”

On page 5 of Amendment No. 2 to Form SB-2 we have revised the second risk factor.

5.

The 23rd and 24th risk factors are duplicative.

On page 10 of Amendment No. 2 to Form SB-2 we have consolidated the 23rd and 24th risk factor in to one risk factor.

Note Regarding Forward-Looking Statements, page 13

6.

We continue to note the statement that you “undertake no obligation to update or revise any of the forward-looking statements after the date of this prospectus to conform forward-looking statements to actual results.” As stated in prior comment 13 to our letter dated September 2, 2005, if new information or certain events arise that would make your current forward-looking statements materially misleading, you would need to update your disclosure as required by federal securities law and the undertakings in Item 28 to the registration statement.

On page 12 of Amendment No. 2 to Form SB-2 we have deleted the statement that we “undertake no obligation to update or revise any of the forward-looking statements after the date of this prospectus to conform forward-looking statements to actual results.”

Management’s Discussion and Analysis of Financial Condition or Plan of Operation

History, page 13

7.

As requested in prior comment 15 to our letter dated September 2, 2005, provide the name and the identity of the control persons and promoters of the company and its predecessors.

On page 12 of Amendment No. 2 to Form SB-2 we have added the names and identity of the control persons and promoters of the Company and its predecessors.

8.

We note that statement in the fourth paragraph that substantially all of the $9.6 million you have raised from the sale of your securities as of July 31, 2005 has been used on development of the TR-DNA technology. We also note that as of July 31, 2005, you have total current assets of $6.5 million, which we presume also was generated from the sale of your securities. Given that you have not generated any revenue to date, we do not understand how you could have expended substantially all of the $9.6 million raised to date on development of the TR-DNA technology and still show total current assets of $6.5 million as of July 31, 2005. We further note that from inception to July 31, 2005, only $2.8 million has been spent on R&D. Please revise.

On page 13 of Amendment No. 2 to Form SB-2 we have revised the fourth paragraph under History to state that we anticipate that substantially all of the $9,643,738 raised will be used on development of the Tr-DNA technology.

Plan of Operations, page 15

9.

Please allocate the amounts necessary over the next 12 months to cover the following budgeted expenses: (1) characterizing molecular markers for two prenatal tests; (2) optimizing detection methods; (3) demonstrating measurement of the markers; (4) converting existing research into methods that can be commercialized; (5) making the required changes to your existing facility or moving to a new facility that meets cGMP guidelines; and (6) purchasing bulk quantities of materials and reagents.

The expenses related to the product development milestones listed in the fourth paragraph of Plan of Operations will primarily consist of labor costs and reagent and chemical costs. On page 14 of Amendment No. 2 to Form SB-2, we have disclosed the aggregate amount of labor costs and reagent and chemical costs we believe will be sufficient for our plan of operations in 2006. It is not possible to accurately predict the exact costs associated with each of these product development steps since our scientific personnel work simultaneously on multiple projects and the various projects may proceed faster or slower than expected, especially those for Down syndrome that are dependent upon gaining access to human clinical samples that are positive for the genetic disorder and the frequency of obtaining such positive sample is beyond our control. We believe it would be misleading to the reader for us to estimate the amount of expenses allocated to each of our product development milestones since there are many variables associated with each product development step and we have no way of predicting the amount of labor costs allocated to each milestone. We believe that an estimate of the aggregate amount of expenses related to what we believe will be accomplished in 2006 is more relevant to the reader.

10.

We note that you do not have any prior manufacturing experience and that this may result in your inability to develop reproducible and effective manufacturing processes. Please consider discussing this in a risk factor.

On page 8 of Amendment No. 2 to Form SB-2 we have added a risk factor entitled “We have limited manufacturing experience and once our products are approved, if at all, we may not be able to manufacture sufficient quantities at an acceptable cost.

11.

The disclosure in the fifth paragraph indicates that your current facility does not meet cGMP guidelines. In the last sentence of the same paragraph you also state that your facilities will be adequate for your anticipated level of activity during 2006. Given that your stated level of activity during the second half of 2006 anticipates you operating under cGMP guidelines, we find these statements confusing.

On page 15 of Amendment No. 2 to Form SB-2 we have modified the last paragraph in our Plan of Operations.

12.

Update the table of contractual obligations on page 16 to at least the most recent balance sheet date.

On page 16 of Amendment No. 2 to Form SB-2 we have updated the table of contractual obligations to October 31, 2005.

13.

The paragraph following the table under Contractual Obligations and Commitments should be updated to the effective date to state the amount owing to the selling stockholders as a result of not having the filing effective on October 25, 2005.

On page 16 of Amendment No. 2 to Form SB-2 we have modified the paragraph following the table of contractual obligations to state that $27,710 is paid every 30 days until the registration statement is effective. We have also added the amount paid to date to such selling stockholders.

14.

Correct the two references to “registration statement”, which apparently should be “registration rights agreement”.

On page 16 of Amendment No. 2 to Form SB-2 we have corrected the two references to registration statement.

Description of Business, page 24

15.

Research and development expenditures for each of the past two fiscal years should be indicated; see Item l0l(b)(10).

On page 20 of Amendment No. 2 to Form SB-2 we have added in our Research and Development expenditures for each of the past two fiscal years and the nine months ended October 31, 2005 and 2004.

Directors and Executive Officers, page 25

16.

Include the disclosure required pursuant to Item 401(a)(3) of Regulation S-B.

On page 24 of Amendment No. 2 to Form SB-2 we have added in the disclosure required pursuant to Item 401(a)(3) of Regulation S-B.

17.

Under “Compliance with Section 16(a) of the Exchange Act,” you indicate that during 2005, your common stock was not registered under Section 12 of the Exchange Act. Please advise how you satisfy the OTCBB listing criteria that all companies be registered under Section 12 prior to trading on the bulletin board.

With all due respect we believe that companies are not required to be registered under Section 12 to be listed on the OTCBB. According to the OTCBB Eligibility Rule, OTCBB issuers must be registered with the SEC under Section 13 or 15(d) of the Securities and Exchange Act of 1934.

Executive Compensation, page 28

18.

Please move the discussion of the consulting agreement with Mr. Cerrone to this section.

The discussion of the consulting agreement with Mr. Cerrone has been moved to “Executive Compensation-Consulting Agreement” on page 28 of Amendment No. 2 to Form SB-2.

19.

Under “Stock Option Plan,” please advise to whom the 1,290,000 options were issued and the value attributed to these options. In this regard, distinguish between third party consultants and employees. Disclose when you will seek stockholder approval for an increase in the number of shares that can be granted under the plan.

On page 29 of Amendment No. 2 to Form SB-2 we have disclosed to whom the 1,326,000 options were granted to as well as the value of such options and the affiliation of such person to the Company. In addition we have disclosed that we will seek stockholder approval in April 2006 for an increase in the number of shares that can be granted under the plan.

20.

Clarify the reference to compensation of “$100,000 or more” in the first paragraph.

On page 27 of Amendment No. 2 to Form SB-2 we have clarified the reference to compensation of $100,000 or more.

Security Ownership of Certain Beneficial Owners and Management, page

21.

Reference is made to footnotes (1) and (3). Beneficial ownership is to be de

Show Raw Text
CORRESP
1
filename1.htm

      SEC Response Letter

    January
      10, 2006

    Securities
      and Exchange Commission

    Division
      of Corporation Finance

    100
      F
      Street, NE

    Washington,
      D.C. 20549

    Attention:
      John Reynolds, Esq.

              Re:

              Xenomics,
                Inc.

              Form
                SB-2 filed August 1, 2005

              Amendment
                No. 1 to Form SB-2 filed October 28, 2005

              File
                No. 333-127071

    Dear
      Mr.
      Reynolds:

    This
      letter sets forth the responses of Xenomics, Inc., a Florida corporation (the
      “Company” or “we”), to the comments received from the Staff (the “Staff”) of the
      Securities and Exchange Commission (the “Commission”) by letter dated November
      28, 2005 concerning the Company’s Registration Statement on Form SB-2 (File No.
      333-127071) filed with the Commission on October 28, 2005 (the “Registration
      Statement”). We are authorized by the Company to provide the responses contained
      in this letter on behalf of the Company.

    The
      numbers of the responses in this letter correspond to the numbers of the Staff’s
      comments as set forth in its letter to the Company dated November 28, 2005.
      References in the text of the responses herein to captions and page numbers
      are
      to Amendment No. 2 to Form SB-2 which is being filed herewith. For your
      convenience, we set forth each comment from your comment letter in bold typeface
      and include the Company’s response below it.

    Table
      of Contents

            1.

              Please
                remove or relocate the boiler-plate paragraph following the table
                of
                contents.

    We
      have
      removed the boiler plate paragraph following the table of contents in Amendment
      No. 2 to Form SB-2.

    Prospectus
      Summary

            2.

              The
                background and development of both Used Kar Parts, Inc. and Xenomics
                Sub
                should be fully discussed pursuant to Item 101 of Regulation
                S-B.

    On
      page 4
      of Amendment No. 2 to Form SB-2 we have modified the Prospectus Summary to
      include the background and development of Used Kar Parts, Inc. and Xenomics
      Sub.

    Risk
      Factors, page 6

            3.

              As
                noted in prior comment 10 to our letter dated September 2, 2005,
                several
                of your risk factors and subheadings are too broad and generic and
                should
                be revised to state the material risk that is specific to Xenomics,
                Inc.
                As a general rule, a risk factor is probably too generic if it is
                readily
                transferable to other offering documents or describes circumstances
                or
                factual situations that are equally applicable to other similarly
                situated
                businesses. Risk factors 10, 12, 14, 21, 27 and 28 should be revised,
                deleted or moved to another section of the
                prospectus.

    On
      pages 5
      to 11of Amendment No. 2 to Form SB-2 we have revised Risk Factors 10, 12, 14,
      21, 26 and 27.

            4.

              The
                second risk factor does not appear material in view of the liquid
                assets
                of the company at the latest balance sheet date and the disclosure
                on page
                16 that “we expect that existing capital resources will be sufficient for
                at least the next twelve
                months.”

    On
      page 5
      of Amendment No. 2 to Form SB-2 we have revised the second risk
      factor.

            5.

              The
                23rd
                and 24th
                risk factors are
                duplicative.

    On
      page 10
      of Amendment No. 2 to Form SB-2 we have consolidated the 23rd
      and
      24th
      risk
      factor in to one risk factor.

    Note
      Regarding Forward-Looking Statements, page 13

            6.

              We
                continue to note the statement that you “undertake no obligation to update
                or revise any of the forward-looking statements after the date of
                this
                prospectus to conform forward-looking statements to actual results.” As
                stated in prior comment 13 to our letter dated September 2, 2005,
                if new
                information or certain events arise that would make your current
                forward-looking statements materially misleading, you would need
                to update
                your disclosure as required by federal securities law and the undertakings
                in Item 28 to the registration
                statement.

    On
      page 12
      of Amendment No. 2 to Form SB-2 we have deleted the statement that we “undertake
      no obligation to update or revise any of the forward-looking statements after
      the date of this prospectus to conform forward-looking statements to actual
      results.”

    Management’s
      Discussion and Analysis of Financial Condition or Plan of
      Operation

    History,
      page 13

            7.

              As
                requested in prior comment 15 to our letter dated September 2, 2005,
                provide the name and the identity of the control persons and promoters
                of
                the company and its
                predecessors.

              On
                page 12 of Amendment No. 2 to Form SB-2 we have added the names and
                identity of the control persons and promoters of the Company and
                its
                predecessors.

            8.

              We
                note that statement in the fourth paragraph that substantially all
                of the
                $9.6 million you have raised from the sale of your securities as
                of July
                31, 2005 has been used on development of the TR-DNA technology. We
                also
                note that as of July 31, 2005, you
                have total current assets of $6.5 million,
                which we presume also was generated from the sale of your securities.
                Given that you have not generated any revenue to date, we do not
                understand how you could have expended substantially all of the $9.6
                million raised to date on development of the TR-DNA technology and
                still
                show total current assets of $6.5 million
                as of July 31, 2005. We
                further note that from inception to July 31, 2005, only $2.8 million
                has
                been spent on R&D. Please
                revise.

    On
      page 13
      of Amendment No. 2 to Form SB-2 we have revised the fourth paragraph under
      History to state that we anticipate that substantially all of the $9,643,738
      raised will be used on development of the Tr-DNA technology.

    Plan
      of Operations, page 15

            9.

              Please
                allocate the amounts necessary over the next 12 months to cover the
                following budgeted expenses: (1) characterizing molecular markers
                for two
                prenatal tests; (2) optimizing detection methods; (3) demonstrating
                measurement of the markers; (4) converting existing research into
                methods
                that can be commercialized; (5) making the required changes to your
                existing facility or moving to a new facility that meets cGMP guidelines;
                and (6) purchasing bulk quantities of materials and
                reagents.

              The
                expenses related to the product development milestones listed in
                the
                fourth paragraph of Plan of Operations will primarily consist of
                labor
                costs and reagent and chemical costs. On page 14 of Amendment No.
                2 to
                Form SB-2, we have disclosed the aggregate amount of labor costs
                and
                reagent and chemical costs we believe will be sufficient for our
                plan of
                operations in 2006. It
                is not possible to accurately predict the exact costs associated
                with each
                of these product development steps since our scientific personnel
                work
                simultaneously on multiple projects and the various projects may
                proceed
                faster or slower than expected, especially those for Down syndrome
                that
                are dependent upon gaining access to human clinical samples that
                are
                positive for the genetic disorder and the frequency of obtaining
                such
                positive sample is beyond our control. We
                believe it would be misleading to the reader for us to estimate the
                amount
                of expenses allocated to each of our product development milestones
                since
                there are many variables associated with each product development
                step and
                we have no way of predicting the amount of labor costs allocated
                to each
                milestone. We believe that an estimate of the aggregate amount of
                expenses
                related to what we believe will be accomplished in 2006 is more relevant
                to the reader.

            10.

              We
                note that you do not have any prior manufacturing experience and
                that this
                may result in your inability to develop reproducible and effective
                manufacturing processes. Please consider discussing this in a risk
                factor.

    On
      page 8
      of Amendment No. 2 to Form SB-2 we have added a risk factor entitled
“We
      have
      limited manufacturing experience and once our products are approved, if at
      all,
      we may not be able to manufacture sufficient quantities at an acceptable
      cost.

            11.

              The
                disclosure in the fifth paragraph indicates that your current facility
                does not meet cGMP guidelines. In the last sentence of the same paragraph
                you also state that your facilities will be adequate for your anticipated
                level of activity during 2006. Given that your stated level of activity
                during the second half of 2006 anticipates you operating under cGMP
                guidelines, we find these statements
                confusing.

    On
      page 15
      of Amendment No. 2 to Form SB-2 we have modified the last paragraph in our
      Plan
      of Operations.

            12.

              Update
                the table of contractual obligations on page 16 to at least the most
                recent balance sheet date.

    On
      page 16
      of Amendment No. 2 to Form SB-2 we have updated the table of contractual
      obligations to October 31, 2005.

            13.

              The
                paragraph following the table under Contractual Obligations and
                Commitments should be updated to the effective date to state the
                amount
                owing to the selling stockholders as a result of not having the filing
                effective on October 25,
                2005.

    On
      page 16
      of Amendment No. 2 to Form SB-2 we have modified the paragraph following the
      table of contractual obligations to state that $27,710 is paid every 30 days
      until the registration statement is effective. We have also added the amount
      paid to date to such selling stockholders.

            14.

              Correct
                the two references to “registration statement”, which apparently should be
                “registration rights
                agreement”.

    On
      page 16
      of Amendment No. 2 to Form SB-2 we have corrected the two references to
      registration statement.

    Description
      of Business, page 24

            15.

              Research
                and development expenditures for each of the past two fiscal years
                should
                be indicated; see Item
                l0l(b)(10).

    On
      page 20
      of Amendment No. 2 to Form SB-2 we have added in our Research and Development
      expenditures for each of the past two fiscal years and the nine months ended
      October 31, 2005 and 2004.

    Directors
      and Executive Officers, page 25

            16.

              Include
                the disclosure required pursuant to Item 401(a)(3) of Regulation
                S-B.

    On
      page 24
      of Amendment No. 2 to Form SB-2 we have added in the disclosure required
      pursuant to Item 401(a)(3) of Regulation S-B.

            17.

              Under
                “Compliance with Section 16(a) of the Exchange Act,” you indicate that
                during 2005, your common stock was not registered under Section 12
                of the
                Exchange Act. Please advise how you satisfy the OTCBB listing criteria
                that all companies be registered under Section 12 prior to trading
                on the
                bulletin board.

    With
      all
      due respect we believe that companies are not required to be registered under
      Section 12 to be listed on the OTCBB. According to the OTCBB Eligibility Rule,
      OTCBB issuers must be registered with the SEC under Section 13 or 15(d) of
      the
      Securities and Exchange Act of 1934.

    Executive
      Compensation, page 28

            18.

              Please
                move the discussion of the consulting agreement with Mr. Cerrone
                to this
                section.

    The
      discussion of the consulting agreement with Mr. Cerrone has been moved to
“Executive Compensation-Consulting Agreement” on page 28 of Amendment No. 2 to
      Form SB-2.

            19.

              Under
                “Stock Option Plan,” please advise to whom the 1,290,000 options were
                issued and the value attributed to these options. In this regard,
                distinguish between third party consultants and employees. Disclose
                when
                you will seek stockholder approval for an increase in the number
                of shares
                that can be granted under the
                plan.

    On
      page 29
      of Amendment No. 2 to Form SB-2 we have disclosed to whom the 1,326,000 options
      were granted to as well as the value of such options and the affiliation of
      such
      person to the Company. In addition we have disclosed that we will seek
      stockholder approval in April 2006 for an increase in the number of shares
      that
      can be granted under the plan.

            20.

              Clarify
                the reference to compensation of “$100,000 or more” in the first
                paragraph.

    On
      page 27
      of Amendment No. 2 to Form SB-2 we have clarified the reference to compensation
      of $100,000 or more.

    Security
      Ownership of Certain Beneficial Owners and Management, page
      33

            21.

              Reference
                is made to footnotes (1) and (3). Beneficial ownership is to be de