SEC Company Response from PROTALEX INC (CIK 0001099215) — Jan 25, 2005
PROTALEX INC (CIK 0001099215)
Date: Jan. 25, 2005 · CIK: 0001099215 · Accession: 0001144204-05-002247
AI Filing Summary & Sentiment
File numbers found in text: 333-109846
Referenced dates: December 1, 2004
Show Raw Text
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Reed Smith Reed Smith LLP
Two Embarcadero Center
Matt Adam Kirmayer Suite 2000
Direct Phone: 415.659.5905 San Francisco, CA 94111-3922
Email: mkirmayer@reedsmith.com 415.543.8700
Fax: 415.391.8269
January 25, 2005
Securities and Exchange Commission
450 Fifth Street, N.W.
Washington, DC 20549
Attention: Albert C. Lee
Re: Protalex, Inc.
Post-Effective Amendment to Form SB-2, filed November 4, 2004
File Number 333-109846
Dear Mr. Lee:
On behalf of Protalex, Inc. (the "Company"), we are responding to the
comments of the Staff of the Securities and Exchange Commission (the
"Commission") contained in your letter dated December 1, 2004 to Steven H. Kane
with respect to the Company's Post-Effective Amendment No. 1 ("Amendment No. 1")
to Form SB-2 (the "Registration Statement") referred to above.
In response to your letter, set forth below are the Staff's comments in
bold followed by the Company's responses to those comments.
Where indicated below, the Company will include changes to the
respective disclosures in the Company's Post-Effective Amendment No. 2 to the
Registration Statement ("Amendment No. 2"), which the Company is filing
contemporaneously with this response letter.
We have sent to your attention three courtesy copies of this letter and
Amendment No. 2, marked to show changes against the initial filing of Amendment
No. 1, as filed with the Commission on January 25, 2005.
FORM SB-2
GENERAL
1. PLEASE NOTE THAT WHERE WE PROVIDE EXAMPLES TO ILLUSTRATE WHAT WE MEAN
BY OUR COMMENTS, THEY ARE EXAMPLES AND NOT COMPLETE LISTS. IF OUR
COMMENTS ARE APPLICABLE TO PORTIONS OF THE FILING THAT WE HAVE NOT
CITED AS EXAMPLES, PLEASE MAKE THE APPROPRIATE CHANGES IN ACCORDANCE
WITH OUR COMMENTS.
The Company acknowledges and will comply with the Staff's comment.
2. PLEASE ELIMINATE JARGON AND TECHNICAL TERMS FROM THE PROSPECTUS AND
PROVIDE A "PLAIN ENGLISH" EXPLANATION OR SUBSTITUTE. FOR EXAMPLE, THESE
WORDS AND PHRASES APPEAR IN THE PROSPECTUS:
o "AUTOIMMUNE"
o "RE-VALIDATION"
o "METABOLIC PATHWAYS"
o "BACTERIAL FERMENTATION"
<PAGE>
o "TISSUE INTEGRITY"
o "ELUCIDATING"
o "IMMUNE DYSREGULATION"
The Company has revised the prospectus to eliminate jargon and
technical terms and has provided "plain English" explanations or substitutes.
PROSPECTUS SUMMARY, PAGE 3
RECENT DEVELOPMENTS, PAGE 3
3. PLEASE REVISE TO QUANTIFY THE AMOUNT OF CAPITAL YOU EXPECT TO NEED IN
ORDER TO DEVELOP YOUR LEAD PRODUCT CANDIDATE.
The Company acknowledges the Staff's comment and has revised its
disclosure under the section titled "Our Company" on page 2, to quantify the
amount of capital the Company expects to need to develop its lead product
candidate.
RISK FACTORS
4. PLEASE REVISE THE RISK FACTORS WHERE APPROPRIATE TO REPLACE GENERIC
LANGUAGE WITH SPECIFIC DISCLOSURE OF EXACTLY HOW THESE RISKS HAVE
AFFECTED AND WILL AFFECT YOUR OPERATIONS, FINANCIAL CONDITION OR
BUSINESS, AND IF PRACTICABLE TO QUANTIFY, THE SPECIFIC AND IMMEDIATE
EFFECTS TO INVESTORS OF EACH RISK THAT YOU HAVE IDENTIFIED. FOR
EXAMPLE, YOU USE GENERAL PHRASES SUCH AS "MATERIAL ADVERSE EFFECT"
THROUGHOUT THE RISK FACTOR SECTION. THESE GENERIC PHRASES ARE SUBJECT
TO VARYING INTERPRETATIONS AND, THEREFORE, DO NOT ADEQUATELY EXPLAIN
THE RISK OR CONCERN TO WHICH YOU REFER. PLEASE REVISE TO DESCRIBE THE
ADVERSE EFFECT(S) IN GREATER DETAIL.
The Company advises the Staff that it has reviewed the "Risk Factors"
section and has made revisions to eliminate generic disclosures per the Staff's
comment. With respect to the specific example highlighted by the Staff, the
prospectus has been revised to replace "material adverse effect" with more
specific language throughout the prospectus.
WE HAVE A HISTORY OF SIGNIFICANT LOSSES ....PAGE 4
5. PLEASE REVISE YOUR STATEMENT THAT YOU EXPECT TO INCUR OPERATING LOSSES
FOR THE NEXT SEVERAL YEARS TO CLARIFY THAT YOU MIGHT NEVER EARN A
PROFIT. ADDITIONALLY, REVISE THE STATEMENT THAT YOU EXPECT RESEARCH AND
DEVELOPMENT AND GENERAL AND ADMINISTRATIVE EXPENSES TO INCREASE OVER
THE NEXT SEVERAL YEARS TO STATE THAT CONSEQUENTLY YOUR LOSSES WILL
INCREASE DURING THIS PERIOD.
In response to the Staff's comment, the Company has revised the
disclosure on page 4 of the prospectus as requested.
IF WE FAIL TO OBTAIN REGULATORY APPROVALS FOR PRTX-100 OR ANY OTHER DRUG ...,
PAGE 4
6. PLEASE REVISE YOUR FILING TO DISCUSS THE RISK THAT YOU MAY ENCOUNTER
DELAYS OR REJECTIONS BASED ON YOUR INABILITY TO ENROLL ENOUGH PATIENTS
AS A SEPARATE RISK FACTOR. THE RISK FACTOR SHOULD FOLLOW A HEADING THAT
IDENTIFIES THE RISK AND POTENTIAL CONSEQUENCES.
-2-
<PAGE>
In response to the Staff's comment, the Company has revised the
prospectus on pages 4-5 to include the risk factor titled "If we are unable to
enroll enough patients to complete our clinical trials, regulatory agencies may
delay their review of or reject our applications, which may result in increased
costs and harm our ability to develop products."
7. TO THE EXTENT YOU HAVE EXPERIENCED ANY OF THE POTENTIAL PROBLEMS
DESCRIBED IN THIS RISK FACTOR FOR PRTX-100 OR ANOTHER PRODUCT IN THE
PAST, PLEASE REVISE TO DESCRIBE THE DIFFICULTIES YOU HAVE EXPERIENCED
AND THE ACTUAL OR EXPECTED CONSEQUENCES.
The Company supplementally advises the Staff that it has not
experienced any of the potential problems described in this risk factor with
respect to PRTX-100 or any other product.
OUR PRODUCTS, IF APPROVED, MAY FAIL TO ACHIEVE MARKET ..., PAGE 3
8. WE NOTE YOU HAVE COMPLETED PRE-CLINICAL STUDIES AND IS PREPARING TO
FILE AN INVESTIGATIONAL NEW DRUG APPLICATION WITH THE FDA, IF THE
STUDIES PRODUCED ANY RESULTS THAT RAISE DOUBTS RELATING TO SAFETY OR
EFFICACY OR ATTRACTIVENESS RELATIVE TO OTHER THERAPIES OR PROCEDURES,
PLEASE REVISE TO DISCLOSE THE RESULTS THAT RAISE SUCH DOUBTS.
The Company supplementally advises the Staff that, to this date, the
Company's pre-clinical studies have not produced results that raise doubts
relating to safety or efficacy or attractiveness relative to other therapies or
procedures.
CLAIMS BY OTHER COMPANIES THAT WE INFRINGE THEIR PROPRIETARY TECHNOLOGY ...,
PAGE 5
9. PLEASE REVISE TO DISCUSS THE RISKS RELATED TO PROTECTION OF YOUR OWN
PATENTS AND TRADE SECRETS AS A SEPARATE RISK FACTOR.
In response to the Staff's comment, the Company has revised the
prospectus on page 5-6 to include the risk factor titled "If we are unable to
protect our proprietary rights, we may not be able to compete effectively or to
operate profitably."
10. TO THE EXTENT YOU ARE AWARE OF ANY INTELLECTUAL PROPRIETARY RIGHTS THAT
ARE BEING INFRINGED UPON OR THAT YOU HAVE BEEN NOTIFIED A THIRD PARTY'S
BELIEF THAT YOU ARE INFRINGING ON THEIR PATENT(S), PLEASE REVISE TO
DISCLOSE THE SITUATION AND POTENTIAL CONSEQUENCES.
The Company supplementally advises the Staff that the Company is
unaware of any intellectual proprietary rights that are being infringed upon by
the Company, and the Company has not been notified of any third party's belief
that the Company is infringing on its patents.
11. RATHER THAN INCLUDE A BULLET POINT LIST OF THE IMPORTANT INTELLECTUAL
PROPERTY FACTORS, PLEASE REVISE TO DISCUSS THE CONSEQUENCES IF YOU ARE
NOT SUCCESSFUL IN ACHIEVING OR IMPLEMENTING THESE FACTORS.
In response to the Staff's comment, the Company has revised the
prospectus on page 6-7. Specifically, as revised, the bulleted factors have been
deleted and the risk factor discusses the consequences of not achieving or
implementing the deleted factors.
-3-
<PAGE>
WE MAY BECOME INVOLVED IN LAWSUITS TO PROTECT OR ENFORCE OUR PATENTS ..., PAGE 5
12. PLEASE ALSO DISCLOSE THAT EVEN AN UNSUCCESSFUL INFRINGEMENT ACTION
AGAINST YOU WOULD BE EXPENSIVE TO DEFEND.
In response to the Staff's comment, the Company has revised the
prospectus on page 6-7. Specifically, as revised, the risk factor explains that
infringement lawsuits can be expensive and would consume time and other
resources even if unsuccessful or brought without merit.
IF THIRD-PARTY MANUFACTURERS OF OUR PRODUCTS FAIL TO DEVOTE SUFFICIENT TIME AND
RESOURCES TO OUR CONCERNS ..., PAGE 7
13. WE NOTE YOUR STATEMENT THAT YOU HAVE CONTRACTED WITH THIRD PARTIES TO
PRODUCE PRTX-100 FOR CLINICAL TRIALS. PLEASE REVISE TO IDENTIFY THE
THIRD PARTY MANUFACTURERS. IF YOU ARE SUBSTANTIALLY DEPENDENT ON THESE
AGREEMENTS, PLEASE FILE THE AGREEMENTS AS EXHIBITS. IF YOU BELIEVE YOU
ARE NOT SUBSTANTIALLY DEPENDENT ON THESE AGREEMENTS, PLEASE PROVIDE US
WITH AN ANALYSIS SUPPORTING YOUR DETERMINATION. SIMILARLY IDENTIFY
PARTIES THAT YOU HAVE MANUFACTURING AGREEMENTS WITH ON PAGE 16.
The Company has revised the prospectus on page 7 to identify Eurogentec
S.A. as the third party contracted to produce PRTX-100 for Phases I and II of
its the clinical trials. Given that the Company has sufficient inventory of
PRTX-100 to finish these phases of its clinical trials, the Company
supplementally advises the Staff that it is not currently substantially
dependent upon any agreement with Eurogentec S.A. or any other third party. As
disclosed in the prospectus on page 7, the Company may be required to rely on
Eurogentec S.A., as well as other third party manufacturers, in the future,
which would subject the Company to the disclosed risks. Supplementally, the
Company advises the Staff that it previously filed as Exhibits 10.5 to the
Company's 10-KSB/A filed on September 24, 2003, the most recent contracts
executed between the Company and Eurogentec S.A.
14. WE NOTE YOU INTEND TO RELY ON THIRD PARTIES FOR THE MANUFACTURE AND
DISTRIBUTION OF YOUR POTENTIAL PRODUCTS. IF YOU HAVE NOT YET IDENTIFIED
PARTIES WILLING AND ABLE TO PERFORM THESE ACTIVITIES, PLEASE REVISE TO
DISCUSS THE CONSEQUENCES IF YOU ARE UNABLE TO IDENTIFY ANY.
In response to the Staff's comment the Company has revised the
prospectus on page 7 to disclose the consequences if the Company is unable to
contract with third parties to manufacture and distribute its potential
products.
WE MAY NOT BE ABLE TO MANUFACTURE OUR PRODUCTS IN COMMERCIAL QUANTITIES ...,
PAGE 7
15. WE NOTE YOUR STATEMENT THAT PRTX-100 HAS ONLY BEEN MANUFACTURED IN
SMALL QUANTITIES. PLEASE REVISE TO INDICATE IF YOU HAVE BEEN
MANUFACTURING THESE QUANTITIES OR IF YOU HAVE BEEN ENTIRELY RELIANT ON
OTHER PARTIES.
In response to the Staff's comment, the Company has revised the
prospectus on pages 7-8. Specifically, as revised, the risk factor states that
the Company contracted with Eurogentec S.A. to produce PRTX-100 for its clinical
trials.
IF WE ARE UNABLE TO RETAIN KEY PERSONNEL AND HIRE ADDITIONAL QUALIFIED ..., PAGE
8
16. IF YOU HAVE EXPERIENCED DIFFICULTIES RECRUITING AND RETAINING
PERSONNEL, PLEASE REVISE TO INCLUDE A RISK FACTOR DISCUSSING THE
DIFFICULTIES YOU HAVE EXPERIENCED AND THE CONSEQUENCES OR POTENTIAL
-4-
<PAGE>
CONSEQUENCES ON YOUR OPERATIONS. THE RISK FACTOR SHOULD DESCRIBE THE
TYPES OF EMPLOYEES YOU HAVE HAD DIFFICULTY RECRUITING OR RETAINING AS
WELL AS THE PROBLEMS AND CONSEQUENCES.
The Company supplementally advises the Staff that, in the recent past,
it has not had difficulty recruiting and retaining personnel, but acknowledges
that there may be difficulties recruiting and retaining personnel in the future.
Accordingly, the Company believes the risk factor, as written, addresses this
prospective risk.
WE MAY BE REQUIRED TO DEFEND LAWSUITS OR PAY DAMAGES IN CONNECTION ..., PAGE 10
17. PLEASE DISCLOSE THE AMOUNT OF COVERAGE FOR THE COMPANY'S PRODUCT
LIABILITY INSURANCE. ALSO, PLEASE DISCLOSE WHETHER THE COMPANY BELIEVES
THIS AMOUNT OF COVERAGE IS SUFFICIENT.
In response to the Staff's comment, the Company has revised the
prospectus on page 10 to disclose that the Company believes its level of general
liability insurance is sufficient for the Company's current needs. The Company
has also revised the prospectus to disclose that the Company maintains general
liability insurance in the amount of $1,000,000 and does not currently maintain
product liability insurance because the Company is not currently conducting
trials involving humans. The Company supplementally advises the Staff that it
intends to acquire product liability insurance before it conducts clinical
trials involving humans.
OUR COMMON STOCK HAS EXPERIENCED IN THE PAST, AND MAY EXPERIENCE IN THE FUTURE,
SIGNIFICANT PRICE VOLATILITY ..., PAGE 10
18. IF YOU HAVE EXPERIENCED VOLATILITY DUE TO ANY OF THE FACTORS LISTED,
PLEASE REVISE TO DESCRIBE THE INSTANCES YOU HAVE EXPERIENCED IN GREATER
DETAIL.
The Company supplementally advises the Staff that the Company has not
experienced volatility due to any of the factors listed in the risk factor.
FUTURE SALES OF COMMON STOCK BY OUR EXISTING STOCKHOLDERS MAY CAUSE OUR STOCK
PRICE TO FALL ..., PAGE 11
19. PLEASE REVISE TO SPECIFICALLY STATE THAT THE SHARES YOU ARE REGISTERING
FOR RESALE ON THIS REGISTRATION STATEMENT REPRESENT A LARGE PORTION OF
YOUR OUTSTANDING COMMON STOCK AND QUANTIFY THE PERCENTAGE THAT THEY
REPRESENT.
In response to the Staff's comment, the Company has revised the
prospectus on page 11. Specifically, as revised, the risk factor states the
Company is registering for resale up to 10,610,049 shares of its common stock,
or approximately 63% of the Company's total outstanding common stock, assuming
full exercise of the warrants.
RECENTLY ENACTED AND PROPOSED CHANGES IN SECURITIES LAWS AND REGULATIONS ARE
LIKELY TO INCREASE OUR COSTS ..., PAGE 11
20. PLEASE REVISE TO EXPLAIN HOW THIS RISK FACTOR AFFECTS YOU DIFFERENTLY
THAN ANY OTHER REPORTING COMPANY. IF IT DOES NOT AFFECT YOU DIFFERENTLY
THAN IT AFFECTS ALL OTHER COMPANIES, THEN DELETE THE DISCUSSION FROM
THE RISK FACTOR SECTION.
-5-
<PAGE>
The Company supplementally advises the Staff that, upon further
consideration, the Company believes that the risk factor does not presently
affect the Company differently than any other reporting company. Consequently,
the Company has deleted this risk factor in response to the Staff's comment.
OUR COMMON STOCK IS TRADED ON THE OTCBB WHICH MAY BE DETRIMENTAL TO INVESTORS,
PAGE 11
21. PLEASE REVISE TO CLARIFY HOW THIS RISK AFFECTS YOU DIFFERENTLY THAN
OTHER COMPANIES LISTED ON THE OTCBB. IF YOU HAVE EXPERIENCED A GREATER
LACK OF LIQUIDITY OR GREATER VOLATILITY THAN OTHER BULLETIN BOARD
LISTED COMPANIES, THESE RESULTS AND ANY OTHER ATTRIBUTING FACTORS
SHOULD BE INCLUDED IN THE DISCUSSION.
The Company supp