SEC Comment Letter for Predictive Oncology Inc. (AGPU) (CIK 0001446159) (AGPU) — Dec 10, 2008
Predictive Oncology Inc. (AGPU) (CIK 0001446159)
Date: Dec. 10, 2008 · CIK: 0001446159 · Accession: 0000000000-08-060895
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File numbers found in text: 333-155299
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December 10, 2008
Mail Stop 3030
Kevin R. Davidson Chief Executive Officer 2060 Centre Pointe Boulevard, Suite 7 Mendota Heights, Minnesota 55120
Re: BioDrain Medical, Inc.
Registration Statement on Form S-1 Filed November 12, 2008
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.
Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filing. We look forward to working with you in these respects. We
welcome any questions you may have about our comments or any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter.
Fee Table
1. Please reconcile your disclosures here and on pages 27 and 58 regarding the
number of warrants issued by you in your August 2008 financing.
2. Given that there does not appear to be an existing market for your securities, your
reference to Rule 457(c) appears to be inapplicable. Please revise.
Prospectus Cover Page
3. Because there is no current market for the registrant’s securities, please revise to
clarify that the selling shareholders will sell at a specified fixed price per share
until the registrant’s shares are quoted on the OTC Bulletin Board (or other
Kevin R. Davidson
BioDrain Medical, Inc.
December 10, 2008 Page 2
specified market) and thereafter at prevaili ng market prices or privately negotiated
prices.
4. We note that you are registering the resale of 620,096 common shares underlying
warrants that are issuable upon conversion of notes. Because the warrants have
not yet been issued, it is premature to register the underlyi ng common shares for
resale. Please remove them from this registration statement.
Prospectus Summary, page 1
Our Company, page 1
5. Please disclose that you have not yet requested or received FDA regulatory
clearance to market and sell your products.
Risk Factors, page 3
6. Include a risk factor to discuss the antic ipated restructuring in the event you do
not obtain FDA approval by August 2009, and di scuss the risks this presents to
potential investors.
7. We note the disclosure on page 49 regardi ng registration of a cl ass of your equity
securities under the Exchange Act. Please tell us when you plan to register a class
of your securities. If you do not intend to re gister a class of securities before this
registration statement is effective, please:
• disclose the risks related to termina tion of periodic disclosure due to the
automatic reporting suspensi on under Section 15(d) of th e Exchange Act; and
• explain the effect of the inapplicability of the proxy rules and Section 16 of
the Exchange Act.
8. It appears from your disclosure on pages 3, 25 and 58 that you recently approved
a reverse stock split that re duced the number of shares you are authorized to issue
to 11,970,994. We also note that you will be submitting a proposal to your
shareholders for approval to increase the number of authorized and unissued
shares. Please ensure that shareholder approval is obtained prior to requesting
acceleration of this registration statement so that the shares being registered for
issuance are actually authorized.
Because we are a development stage company . . ., page 3
9. Please reconcile your disclosure here and on page 13 regarding whether you will receive proceeds from this offering. If the proceeds you will receive from this
Kevin R. Davidson
BioDrain Medical, Inc.
December 10, 2008 Page 3
offering depend solely on whether the hol ders of outstanding warrants exercise
those securities, then please revise to clarify that fact here.
Our business would be materially a nd adversely affected . . ., page 4
10. Please clarify the nature of your interest in the intellectual property you claim.
For example, you indicate in the first se ntence on page 5 that the intellectual
property developed by Mr. Ryan was “lic ensed” to you. However, the last
sentence of this risk factor states that you are the “exclusive owne r of the patent.”
Additionally, you indicate on pages 1 and 4 that you own patent and patent-
pending rights and disclose on page 32 th at you are the assignee of “the patent-
pending product.”
11. We note the disclosure that Mr. Ryan was added as a named inventor to the
pending patent application. We also not e the disclosure that you removed from
the U.S. patent application Messrs. Nord a nd Drogue as inventors. However, it is
our understanding that Messrs. Nord and Drogue continue to be listed as inventors
on the pending application and that Mr. Ryan is not listed as an inventor. Please
revise or advise.
We face intense competition . . ., page 5
12. Please provide us with supplemental suppor t for the data referenced in your
prospectus, marking the relevant sections to support the disclosure. For example,
you cite to Frost & Sullivan here and page 28. You also cite to numerous other
publications throughout your “Description of Business” section. Also, please tell
us whether the studies and articles you cite were financed by you or performed at your direction and whether the authors have consented to use of their name in this document.
13. It is generally inappropriate for a risk f actor to contain language that mitigates the
risk discussed. We note specifically th e discussion at the end of the first
paragraph regarding the “distinct advantag es” of your product. Also, it appears
that Stryker and other competitors have designed systems that also eliminate
handling and exposure to infectious fluids, so the disclosure, if retained, should be
more balanced.
Our products require FDA approval . . ., page 6
14. Given the variety of uncertainties discusse d in this risk fact or, please revise the
first paragraph to remove your belief th at “the likelihood of regulatory approval
for our products is very high.”
Kevin R. Davidson
BioDrain Medical, Inc.
December 10, 2008 Page 4 15. Expand to discuss your obligation to obt ain FDA approval by the end of August,
2009, and the related risks if you have not done so, as described on pages 39 and 40.
There is currently no public tr ading market . . ., page 8
16. Please clarify when you anticipate submitti ng an application for quotation to the
OTC Bulletin Board. Also disclose any obstacles that exist before such an
application will be submitted and accepted. For example, it is our understanding
that an application for quotation must be submitted by a market maker. Has a market maker already committed to submitting such an application?
If our common stock is accepted for quotation . . ., page 9
17. We note the reference here and your prospectus cover page to applying for trading
on the Nasdaq or NYSE markets. Please disclose here and on your cover page
whether you currently meet the objective li sting criteria for those markets. Also
disclose here what hurdles remain before you will satisfy those criteria.
Other Securities For Issuance Upon Certain Contingencies, page 18
18. Please disclose the identities of the pe rsons with whom you entered into the
agreements mentioned here. Also descri be the nature of the services to be
provided by the regulatory consultant and file that agreement as an exhibit.
Include a description of the purpose of th e provision requiring the attainment of
performance goals and disclosure of those performance goals.
19. Please expand the notes to financial st atements to describe the equity
arrangements disclosed under this heading. Your disclo sure should fully describe
the accounting applied or that will be a pplied, as appropriate, and the basis in
GAAP for that accounting. The disclosure should also describe the specific
performance goals and any other conditions of the grants that impact vesting or
exercisability. Refer to SFAS 123(R) for fu rther guidance. Please ensure that the
notes to financial statements include di sclosure about all obl igations to issue
equity securities, including contingent obligations.
Management’s Discussion and Analysis . . ., page 20
20. We note your disclosure that your capital requirements for the next 12 months are
expected to be “rather moderate.” Pl ease reconcile this statement with your
disclosure on page 3 that you will need to raise at least $3 million in order to have sufficient financial resources to fund our operations for the next 12 months and
Kevin R. Davidson
BioDrain Medical, Inc.
December 10, 2008 Page 5
your disclosure on page 22 that you antic ipate needing a secondary financing
during 2009.
Critical Accounting Policies and Estimates, page 20
21. Please revise to provide a discussion of your critical accounting policies and
estimates. This discussion should pres ent your analysis of the uncertainties
involved in applying an accounti ng principle at a given time or the variability that
is reasonably likely to result from its application over time. You should address
specifically why your accounting estimates or assumptions bear the risk of
change. For example, it appears that ther e is significant judgment in valuing stock
options and warrants. Refer to FR-72.
Results of Operations, page 21
22. We see that general and administrative e xpense increased in the six months ended
June 30, 2008 in part due to $91,400 of “produc t development” costs. In addition,
you disclose that research and developm ent costs increased to $91,400 for the six
months ended June 30, 2008. Please explain whether these disclosures are
referring to the same expenses and, if so, how they can be included in two
different expense classifications. Please revise as appropriate.
23. Please revise to discuss the reasons fo r the increase in legal fees of $78,500 and
salaries of $68,100 for 2008 compared to 2007.
24. We reference the disclosure that resear ch and development expense increased in
2008 due to “an accumulation of unbilled work from 2003 to 2007” and the
discussion of the increase in research and development expense in 2006 due to
“unbilled development fees since inception.” Please revise to discuss the nature
of the unbilled work, the timing of the billings for work performed and the
circumstances that resulted in th e aforementioned increased expenses.
25. As a related matter, it would appear unus ual for a third party to incur billable
work since 2003 without billing and paym ent. If you have incurred costs or
entered into other transactions with related parties, such as non-employee
shareholders, please ensure that the notes to financial statements provide all of the
disclosures required by SFAS 57.
26. With a view toward disclosure, tell us to whom the $91,400 was paid.
27. You disclose that accrued payroll to taling $336,600 was “eliminated” in 2007.
Please expand the notes to financial statements to describe this significant transaction and the accounting applied. If these individuals were also
shareholders, it is not clear why the “elimination” of these salaries is not a capital
Kevin R. Davidson
BioDrain Medical, Inc.
December 10, 2008 Page 6
contribution. Accordingly, please expl ain to us the basi s in GAAP for your
accounting. We refer you to APB 26.
28. Further, please clarify in MD&A why general and administrative expenses for six months ended June 30, 2007 are 153,900 but general and administrative expenses
for the year ended 12/31/07 are $125,300. If th is is related to the “elimination” of
payroll, please elaborate by providing additional disclosu re in your MD&A.
Liquidity and Capital Resources, page 21
29. We note your disclosure on page 22 regard ing sufficiency of funds through the
first half of 2009 and anticipated need fo r a secondary financing. We also note
your disclosure on page 3 regarding the need to raise $3 million to fund your
operations for the next 12 months. Pl ease provide investors with a better
understanding of your currently known capital requirements and amounts needed
to satisfy your outstanding obligations. For example, discuss and quantify, among
other things:
• the accrued payroll expenses as of June 30, 2008 noted on page 3;
• the amounts necessary to seek and obtain approval from the FDA and Underwriters Laboratories mentioned on page 39;
• the expenses you will incur in connection with this offering, as noted on page II-4;
• the fees you owe in connection with your August 2008 financing, as noted on
page 4;
• any ongoing payments required by you to satisfy outstanding debt, such as the
instruments mentioned on page 23, in cluding if the holders of those
instruments decide not to receive shares in lieu of cash; and
• the amount you will need to satisfy your reporting obligations under the
Exchange Act.
Please also provide your assessment of the accessibility of and risks to accessing needed capital. For example, will your doubts about your ability to continue as a
going concern make your access to needed capital more difficult or expensive?
How does your statement regarding su fficiency of funds account for the
uncertainty regarding whether holders of your outstanding warrants will exercise
those securities?
30. We see that you have experienced recu rring operating losses and negative cash
flows. We also note that you will need significant additional capital to fund the
development of your business. Please e xpand the disclosure in this section to
discuss the following:
Kevin R. Davidson
BioDrain Medical, Inc.
December 10, 2008 Page 7
• Your plan of operation for the next twelve months, including a how you
expect to obtain addition al financing and plans for the “secondary financing”
that is anticipated in 2009;
• The effect of the current economic conditions on your operating plans;
• A summary of any product research a nd development that you will perform
for the term of the plan;
• An indication of the amount of cash that will be required to bring your
products under development to market;
• Any expected purchase or sale of pl ant and significant equipment; and
• Any expected significant changes in the number of employees.
Refer to Item 303 of Regulation S-K.
Six Months Ended June 30, 2008 and 2007, page 22
31. Please clarify how net cash provided by fi nancing activities increased during the
six months ended June 30, 2008 due to the receipt of investment capital from a
private offering that occurred subs equent to that period.
Commitments and Contingencies, page 22
32. From your disclosure on page 23, it appears that notes payable previously issued
by you are now overdue. Please disclose th e potential consequences of failing to
make required payments on these instrume nts, such as quantification of the
monetary payments mentioned on page 59. Please also refer to our first comment
under the heading “Liquidity and Capital Resources.”
33. Please disclose the number of shares into which the $100,000 note payable may
be converted. Given the dates on which exhibits 10.20 and 10.21 were executed and the disclosure in your document regarding the August 2008 private placement, it appears that the “next completed financing” has already occurred.
Stock Options and Warrants, page 24
34. Please tell us why your tables here and page 25 do not include
• the stock option issuance to Mr. Ruwe on June 16, 2008 that is mentioned on
page 46;
• the stock option grant to Mr. Davidson on June 5, 2008 that is mentioned on
page 44; and
Kevin R. Davidson
BioDrain Medical, Inc.
Decembe