SEC Comment Letter for Predictive Oncology Inc. (AGPU) (CIK 0001446159) (AGPU) — Jun 5, 2009
Predictive Oncology Inc. (AGPU) (CIK 0001446159)
Date: June 5, 2009 · CIK: 0001446159 · Accession: 0000000000-09-030100
AI Filing Summary & Sentiment
File numbers found in text: 333-155299
Referenced dates: February 24, 2009
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
DIVISION OF
CORPORATION FINANCE
Mail Stop 3030
June 5, 2009
Kevin R. Davidson Chief Executive Officer 2060 Centre Pointe Boulevard, Suite 7 Mendota Heights, Minnesota 55120
Re: BioDrain Medical, Inc.
Amendment No. 4 to Registrati on Statement on Form S-1
Filed May 14, 2009
File No. 333-155299
Dear Mr. Davidson:
We have reviewed your filing and have the following comments. Where
indicated, we think you should re vise your document in response to these comments. If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary. Please be as deta iled as necessary in your explanation. In
some of our comments, we may ask you to provi de us with information so we may better
understand your disclosure. After reviewing th is information, we may raise additional
comments.
We welcome any questions you may have about our comments or any other
aspect of our review. Feel fr ee to call us at the telephone numbe rs listed at the end of this
letter.
Fee Table
1. Refer to prior comment 2 in our letter dated February 24, 2009 and tell us why
your fee table has been revised to refer to the maximum offering price of “N/A,” given your disclosure that the selling shar eholders will sell at the fixed price of
$0.46 per share until your shares are quoted on the Over-the-Counter Bulletin
Board.
Prospectus Summary, page 1
2. Your disclosure here and on page 49 indi cates that you have not yet requested or
received FDA regulatory clearance to market or sell our products. Your
Kevin R. Davidson
BioDrain Medical, Inc.
June 5, 2009 Page 2
disclosure on pages 6, 24 and 30 indicate that you received “final” FDA clearance
on April 1, 2009. Please reconcile.
Critical Accounting Policies and Estimates, page 19
Stock Based Compensation, page 19
3. We reference the revisions made in response to prior comment 4. Since your
common stock is not currently listed on an exchange there appears to be judgment
in determining the fair value of the u nderlying stock when valuing stock options
and warrants. As such, please revise to discuss how you determine the fair value
of common stock when using the Black-Sc holes-Merton option-pr icing model.
4. In addition, please revise th is section to discuss how you determine measurement
dates for non-employee stock transac tions and the judgments involved in
assessing probability when accounting for equity inst ruments with performance
and service conditions. Refer to SEC Release No. 33-8040, Cautionary Advice
Regarding Disclosure about Crit ical Accounting Policies.
Recent Accounting Developments, page 21
5. You disclose that you believe FSP APB N o. 14-1 will apply to your contingent
convertible senior notes. Accordingly, tell us how you concluded that the
adoption of the FSP will “not have a materi al impact to [your] financial position,
results of operations and liquidity.”
Results of Operations - Twelve Months Ended December 31, 2008 and 2007, page 21
6. We note your explanation that general and administrative expenses increased in-
part due to legal fees in connection with your October 2008 financing. To the
extent legal fees incurred were directly attributable to th e October 2008 financing,
clarify for us how your accounting consider s the guidance from SAB Topic 5A.
Liquidity and Capital Resources, page 22
7. Regarding your response to prior comment 9:
• The second paragraph under this caption states that the table that follows
summarizes your currently known capita l requirements and outstanding
obligations. However, your response to prior comment 9 im plies that such
table does not summarize your outst anding debt and other contractual
obligations, such as those menti oned on page 25. If your “Capital
Requirements” table does not include a ll of your outstanding obligations, then
please revise the second paragraph to re move any implication to the contrary
Kevin R. Davidson
BioDrain Medical, Inc.
June 5, 2009 Page 3
and to tell investors where in your document they can find information
relating to your other ou tstanding obligations;
• Refer to the second full paragraph on page 24. Expand to clarify why your
“ability to raise this new capital is in substantial doubt.” For example, does
your early stage position and history of losses make it more difficult to raise
capital?; and
• Tell us the reasons for your deletions to the fourth paragraph on page 24. Do
the holders of your debt no longer have a secured interest in your assets or
have they agreed to no t seize your assets?
Commitments and Contingencies, page 25
8. We refer to the responses to prior comments 7 and 8. Please expand the
disclosures about the reduc tion of accrued salaries on pages 26 and F-18 to
address the following:
• Clarify how the amounts waived in 2007 sum to the $346,714 recorded as a
capital contribution in the statem ent of stockholders’ deficit.
• Clarify that the reduction of accrued pa yroll liabilities wa s recorded as a
capital contribution and disclose the rationale in GAAP on which the
accounting is based.
• Disclose the periods that the servic es were rendered. We see from your
response to the prior comment that $244,000 of accrued salaries was earned in 2006.
Other Securities For Issuance . . ., page 30
9. We note from the disclosure added here in response to prior comment 10 that Mr.
Dauwalter received “an additional 20,000 shares, for a total of 30,000 vested
shares” as a result of “FDA application and final clearance.” Please tell us which provision of exhibits 10.37 or 10.38 provide that the opti ons would vest according
to that schedule. It appears from thos e exhibits that Mr. Dauwalter was only
entitled to receive 10,000 shares upon execution of the agreement and an
additional 10,000 shares upon approval by the FDA.
Industry and Market Analysis, page 32
10. We note your response to prior comment 13. We reissue that comment because
you have not yet provided us with copies of the Outpatient Surgery Magazine
article cited in your disclosure.
Kevin R. Davidson
BioDrain Medical, Inc.
June 5, 2009 Page 4 Corporate Strategy, page 40
11. We note your revisions in response to pr ior comment 15. However, it continues
to be unclear how your management’s “international manufacturing experience” will allow you to “develop global purchasing and/or manufacturing sources for key sub-assemblies.” It is also unclear how these “key sub-assemblies” will
“drive a significant per unit cost reduction.” Therefore, we reissue the comment.
If you mean that you may seek to manuf acture your products outside the United
States because it would be cheaper to do so, then please revise for clarity.
Handling Costs, page 44
12. We reissue prior comment 17 because alt hough your response states that “[t]his
section has been updated,” it app ears no revisions were made.
Engineering and Manufacturing, page 47
13. Your response to prior comment 18 and di sclosure on page 48 indicates that you
have no minimum purchase obligation with respect to the cleaning fluid. Please
reconcile those statements with the term s of exhibit 10.47, including the last table
in exhibit B and sect ions 2.1(i) and 6.3.
14. We note that you intend to submit a request for confidential treatment with regard
to exhibit 10.47, and deleted information on pa ge 2 of exhibit B. It appears that
you also deleted the pricing information from page 1 of exhibit B, but did not note
the deletion. Please refile the exhibit and ensure that all deleted information is
appropriately marked.
Directors, Executive Officers, Promoters and Control Persons, page 53
15. Please expand your response to prior comment 21 to clarify how you reached your conclusions regarding Mr. Shuler’s l ack of policy making functions and that
he is not an employee, given your respons e to prior comment 19 that “Mr. Shuler
has been appointed Corporate Secretary.”
Summary Compensation Table, page 56
16. We note your response to prior comment 22:
• Please disclose your response to fi rst bullet of prior comment 22;
• We reissue the third bullet of prio r comment 22, which sought disclosure
regarding the reasons for awarding Mr. Davidson a $25,000 bonus, not merely
a response. When providing such disclo sure, please ensure you fully explain
the basis for the bonus in light of the liq uidity issues you disclose. In this
Kevin R. Davidson
BioDrain Medical, Inc.
June 5, 2009 Page 5
regard, we note your response that the bonus was “merit based,” which does not appear to adequately explain why the bonus was awarded.
Outstanding Equity Awards . . ., page 58
17. We note your response to prior comment 23. If the issuance of the 80,000 and
160,000 options to Messrs. Davidson and Rice is contingent on raising $3 million,
then please revise note 1 to your table to remove the implication that “vesting” is
contingent on raising $3 million.
Selling Security Holders, page 64
18. Please tell us why your disclosure on page 71 includes shares held by David Dauwalter in determining James Dauwalter’ s beneficial ownership, but your table
here appears to exclude those shares. Li kewise, please tell us why your disclosure
here and on page 71 treats differently shares owned by the family members of Mr. Chad Ruwe and Mr. James Dauwalter.
Security Ownership . . ., page 70
19. We note the reduced numbers in the ta ble on page 71 for Messrs. Patel and
Richardson. Those numbers do not equal th e totals of the shares disclosed in
notes 12 and 13. Please revise or advise.
Warrants and Convertible Debt, page 73
20. Refer to the first paragraph following the table on page 74. Given your disclosure
there and on page F-21, it appears that the penalties and additional shares you
mention are already required to be paid and issued by you. If so, please revise to
state so directly, includi ng that amount that you are obligated to pay as of the
most recent practicable date. Also note your obligations under Items 403, 404 and 507 of Regulation S-K.
Legal Matters and Interests of Named Experts, page 79
21. Regarding your response to prior comment 31:
• Disclose the $150,000 debt you owe to the law firm; and
• Tell us why you deleted disclosure from this section that the notes held by
members of the law firm are in defau lt and regarding pena lty provisions that
apply if this registration statement does not become effective within a
particular time frame. If that “p articular time frame” has passed, as is
indicated by your disclosure on page 74 and F-21, then include disclosure
regarding the amount of penalties that has accrued.
Kevin R. Davidson
BioDrain Medical, Inc.
June 5, 2009 Page 6 Financial Statements, page F-1
22. Please update the financial statements wh en required by Rule 8-08 of Regulation
S-X.
23. We see that the balance sheet and stat ements of operations, cash flows and
stockholders’ deficit have been adjusted as of and for the year ended December
31, 2008. Please revise to labe l those financial statements as “restated” and to
include the disclosures required by paragraph 26 of SFAS 154.
Report of Independent Registered Public Accounting Firm, page F-2
24. We note that you have restated your financial statements. Please have your
auditors revise the audit opinion to reference the fact that the financial statements have been restated. In addition, please tell us how your auditors considered whether they should update the date of the report as a resu lt of the restatements.
Note 1. Product Development, page F-9
25. If what you refer to as product developmen t costs is research and development as
defined in SFAS 2, please revise to clar ify. If it is not, please disclose the
amounts of research and development e xpense for each period as required by
paragraph 13 of SFAS 2.
Note 3. Stockholders’ Deficit, Stoc k Options and Warrants, page F-10
Valuation and accounting for optio ns and warrants, page F-12
26. Please revise to provide the disclosu res required by paragraphs A240(c) and
A240(d) of SFAS 123-R. Please also disclose the total compensation cost for share-based payment arrangements r ecognized in income, as required by
paragraph A240(g)(1) of SFAS 123-R.
Warrants, page F-14
27. While we acknowledge your response to prior comment 46, it continues to be
unclear how the paragraphs under the caption “Warrants” address the full 5.7
million warrants granted in 2008 as reflected in the table on page F-12. Please revise to include disclosure about all warrants issued dur ing 2008 or show us that
the discussion is complete.
Kevin R. Davidson
BioDrain Medical, Inc.
June 5, 2009 Page 7 Note 11. Restatement of 2007, page F-22
28. Please revise to provide all of the disc losures required by paragraph 26 of SFAS
154. The expanded disclosure should provide the originally repor ted balance, the
impact of each
individual restatement adjustment and the “as restated” balance for
each restated financial statement caption.
29. Please also revise to provide a complete na rrative description of (1) the nature of,
(2) the reasons for and (3) the quantitative impact of each
restatement adjustment.
The expanded disclosure should also clarify why management believes the
original accounting was incorrect and clar ify the basis in GAAP for the revised
accounting.
30. In addition, please revise to disclose th e impact of the restatements on earnings
per share for all periods presented. Refer to paragraph 26 of SFAS 154.
Exhibit 23.1
31. Please include a currently dated and si gned consent from your independent
auditors prior to requ esting effectiveness.
32. The consent included as Exhibit 23.1 refers to an audit repor t dated May 14, 2009.
Please reconcile that statemen t with the date of the current audit report included in
your registration statement, which is April 3, 2009.
* * * * * * *
As appropriate, please amend your regist ration statement in response to these
comments. You may wish to provide us with marked copies of the amendment to expedite our review. Please furnish a cove r letter with your amendment that keys your
responses to our comments and provides any requested information. Detailed cover
letters greatly facilitate our review. Please understand that we may have additional comments after reviewing your amendmen t and responses to our comments.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filing to be certain that the filing includes all in formation required under
the Securities Act of 1933 and that they have provided all information investors require
for an informed investment decision. Since the company and its management are in possession of all facts relating to a company’ s disclosure, they are responsible for the
accuracy and adequacy of the disclosures they have made.
Kevin R. Davidson
BioDrain Medical, Inc. June 5, 2009 Page 8 In addition, please be advi sed that the Division of En forcement has access to all
information you provide to the staff of the Di vision of Corporation Finance in connection
with our review of your filing or in response to our comments on your filing.
We will consider a written request for acceleration of the effective date of the
registration statement as conf irmation of the fact that t hose requesting acceleration are
aware of their respective re sponsibilities under the S ecurities Act of 1933 and the
Securities Exchange Act of 1934 as they rela te to the proposed public offering of the
securities specified in the above registration statement. We will act on the request and,
pursuant to delegated authority, grant acce leration of the effective date.
We direct your attention to Rules 46 0 and 461 regarding requesting acceleration
of a registration statement. Please allow ad equate time after the filing of any amendment
fo