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
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CORRESP
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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