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SEC Comment Letters
Company Responses
Letter Text
FILANA THERAPEUTICS, INC.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
FILANA THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
FILANA THERAPEUTICS, INC.
Response Received
5 company response(s)
High - file number match
Company responded
2006-06-06
FILANA THERAPEUTICS, INC.
References: May 22,
2006 | May 25, 2004
↓
Company responded
2006-06-22
FILANA THERAPEUTICS, INC.
References: May 22, 2006
↓
↓
Company responded
2009-12-04
FILANA THERAPEUTICS, INC.
References: November 9, 2009
Filing - Correspondence from FILANA THERAPEUTICS, INC.
CORRESP · 2009-12-04
Generating summary...
↓
Company responded
2009-12-18
FILANA THERAPEUTICS, INC.
References: December 14, 2009 | December 4, 2009
Filing - Correspondence from FILANA THERAPEUTICS, INC.
CORRESP · 2009-12-18
Generating summary...
↓
Company responded
2023-08-10
FILANA THERAPEUTICS, INC.
References: July 28, 2023
Filing - Correspondence from FILANA THERAPEUTICS, INC.
CORRESP · 2023-08-10
Generating summary...
FILANA THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
FILANA THERAPEUTICS, INC.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2020-04-02
FILANA THERAPEUTICS, INC.
Filing - SEC Comment Letter to FILANA THERAPEUTICS, INC.
UPLOAD · 2020-04-02
Generating summary...
↓
Company responded
2020-04-09
FILANA THERAPEUTICS, INC.
References: April 2, 2020
Filing - Correspondence from FILANA THERAPEUTICS, INC.
CORRESP · 2020-04-09
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↓
Company responded
2020-05-01
FILANA THERAPEUTICS, INC.
Filing - Correspondence from FILANA THERAPEUTICS, INC.
CORRESP · 2020-05-01
Generating summary...
FILANA THERAPEUTICS, INC.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2018-12-21
FILANA THERAPEUTICS, INC.
Filing - SEC Comment Letter to FILANA THERAPEUTICS, INC.
UPLOAD · 2018-12-21
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↓
Company responded
2019-01-28
FILANA THERAPEUTICS, INC.
Filing - Correspondence from FILANA THERAPEUTICS, INC.
CORRESP · 2019-01-28
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FILANA THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2017-04-25
FILANA THERAPEUTICS, INC.
Filing - SEC Comment Letter to FILANA THERAPEUTICS, INC.
UPLOAD · 2017-04-25
Generating summary...
FILANA THERAPEUTICS, INC.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2010-08-06
FILANA THERAPEUTICS, INC.
Filing - Correspondence from FILANA THERAPEUTICS, INC.
CORRESP · 2010-08-06
Generating summary...
FILANA THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-02-19
FILANA THERAPEUTICS, INC.
Filing - SEC Comment Letter to FILANA THERAPEUTICS, INC.
UPLOAD · 2010-02-19
Generating summary...
FILANA THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-01-26
FILANA THERAPEUTICS, INC.
Filing - SEC Comment Letter to FILANA THERAPEUTICS, INC.
UPLOAD · 2010-01-26
Generating summary...
FILANA THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2009-12-14
FILANA THERAPEUTICS, INC.
Filing - SEC Comment Letter to FILANA THERAPEUTICS, INC.
UPLOAD · 2009-12-14
Generating summary...
FILANA THERAPEUTICS, INC.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2009-11-09
FILANA THERAPEUTICS, INC.
Filing - SEC Comment Letter to FILANA THERAPEUTICS, INC.
UPLOAD · 2009-11-09
Generating summary...
↓
Company responded
2009-11-25
FILANA THERAPEUTICS, INC.
Filing - Correspondence from FILANA THERAPEUTICS, INC.
CORRESP · 2009-11-25
Generating summary...
FILANA THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2006-10-24
FILANA THERAPEUTICS, INC.
Filing - SEC Comment Letter to FILANA THERAPEUTICS, INC.
UPLOAD · 2006-10-24
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-03 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-08-14 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-08-10 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-07-28 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2020-05-01 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2020-04-09 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2020-04-02 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2019-01-28 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2018-12-21 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2017-04-25 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2010-08-06 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2010-02-19 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2010-01-26 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2009-12-18 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2009-12-14 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2009-12-04 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2009-11-25 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2009-11-09 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2006-10-24 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2006-10-24 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2006-06-22 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2006-06-06 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2023-08-14 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-07-28 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2020-04-02 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2018-12-21 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2017-04-25 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2010-02-19 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2010-01-26 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2009-12-14 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2009-11-09 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2006-10-24 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2006-10-24 | SEC Comment Letter | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-03 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2023-08-10 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2020-05-01 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2020-04-09 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2019-01-28 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2010-08-06 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2009-12-18 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2009-12-04 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2009-11-25 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2006-06-22 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
| 2006-06-06 | Company Response | FILANA THERAPEUTICS, INC. | DE | N/A | Read Filing View |
2025-12-03 - CORRESP - FILANA THERAPEUTICS, INC.
CORRESP 1 filename1.htm CASSAVA SCIENCES, INC. 6801 N. Capital of Texas, Building 1 Suite 300 Austin, TX 78731 December 3, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, DC 20549 Attn: Jessica Dickerson Re: Cassava Sciences, Inc. Registration Statement No. 333-291489 Ladies and Gentlemen: On behalf of Cassava Sciences, Inc. (the " Company "), the undersigned hereby requests, pursuant to Rule 461 promulgated under the Securities Act of 1933, that the effective time of the Registration Statement on Form S-3 (File No. 333-291489) filed on November 13, 2025 (the " Registration Statement ") be accelerated to 4:15 p.m., New York City time, on Friday, December 5, 2025, or as soon as practicable thereafter. The Company respectfully requests that you notify Peter E. Devlin of such effectiveness by a telephone call to (212) 326-3978. Should you have any questions regarding the Registration Statement, please contact Peter E. Devlin at (212) 326-3978. Thank you for your attention to this matter. Sincerely, CASSAVA SCIENCES, INC. By: /s/ Richard J. Barry Name: Richard J. Barry Title: President and Chief Executive Officer cc: Peter E. Devlin Ferrell M. Keel Jones Day
2023-08-14 - UPLOAD - FILANA THERAPEUTICS, INC.
United States securities and exchange commission logo
August 14, 2023
Eric Schoen
Chief Financial Officer
Cassava Sciences, Inc.
6801 N. Capital of Texas Highway, Building 1, Suite 300
Austin, TX 78731
Re:Cassava Sciences, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2022
Filed February 28, 2023
File No. 000-29959
Dear Eric Schoen:
We have completed our review of your filings. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2023-08-10 - CORRESP - FILANA THERAPEUTICS, INC.
CORRESP 1 filename1.htm Cassava - SEC Response Letter (10-k) draft August 10, 2023 VIA EDGAR Division of Corporation Finance Office of Life Sciences United States Securities and Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attention: Tara Harkins Dan Gordon Re: Cassava Sciences, Inc. Form 10-K for the Fiscal Year Ended December 31, 2022 Filed February 28, 2023 File No. 000-29959 Ladies and Gentlemen: Cassava Sciences, Inc. (the “Company,” “we” or “our”) is in receipt of the comment of the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) set forth in the Commission’s letter dated July 28, 2023 (the “Comment Letter”) with respect to the Company’s Form 10-K for the fiscal year ended December 31, 2022 filed with the Commission on February 28, 2023 (the “FY 2022 Form 10-K”). For the convenience of the Staff, we have incorporated the text of the Staff’s comment in the Comment Letter into this response letter in italicized type, which is followed by the Company’s response. Page number references are to the FY2022 Form 10-K. Components of Operating Results, page 78 1. We note the discussion on page 77 that you currently have two biopharmaceutical assets under development, simufilam and SavaDx, and that you are in stage 3 of clinical trials for some of these products. Please revise future filings to disclose the costs incurred during each period presented for each of your key research and development products/projects. If you do not track your research and development costs by project, disclose that fact and explain why you do not maintain and evaluate research and development costs by project. Provide other quantitative or qualitative disclosure that provides more transparency as to the type of research and development expenses incurred (i.e., by nature or type of expense) which should reconcile to total research and development expenses on the Consolidated Statements of Operations. Response: We respectfully acknowledge the Staff’s comment and offer the following response. Our research and development costs for SavaDx are not material to the Company because these expenses represent less than 1% of total research and developments costs for all periods presented. We will disclose that SavaDx research and development expenses represent less than 1% of total research and developments costs in future filings. We do not believe a further numerical disaggregation between simufilam and SavaDx research and development costs would be useful to a user of the financial statements and would be duplicative of the “less than 1%” contextual disclosure. Thus, we do not plan to include a numerical disaggregation. We will modify this disclosure if SavaDx research and development costs were to become significant in the future. We will also provide additional quantitative and qualitative disclosure of our research and development expenses by nature and type of expense in future filings. This disclosure will be reconciled to total research and development expenses in the Consolidated Statements of Operations. If you have any questions or comments concerning this submission, please do not hesitate to contact me at (512) 501-2450 or via email at eschoen@cassavasciences.com. Sincerely, /s/ Eric J. Schoen Eric Schoen Chief Financial Officer Cassava Sciences, Inc. cc: Brett Cooper, Esq., Orrick, Herrington & Sutcliffe LLP
2023-07-28 - UPLOAD - FILANA THERAPEUTICS, INC.
United States securities and exchange commission logo
July 28, 2023
Eric Schoen
Chief Financial Officer
Cassava Sciences, Inc.
6801 N. Capital of Texas Highway, Building 1, Suite 300
Austin, TX 78731
Re:Cassava Sciences, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2022
Filed February 28, 2023
File No. 000-29959
Dear Eric Schoen:
We have reviewed your filing and have the following comment. In our comment, we
may ask you to provide us with information so we may better understand your disclosure.
Please respond to this comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this comment, we may have additional comments.
FirstName LastNameEric Schoen
Comapany NameCassava Sciences, Inc.
July 28, 2023 Page 2
FirstName LastName
Eric Schoen
Cassava Sciences, Inc.
July 28, 2023
Page 2
Form 10-K for the Fiscal Year Ended December 31, 2022
Components of Operating Results, page 78
1.We note the discussion on page 77 that you currently have two biopharmaceutical assets
under development, simufilam and SavaDx, and that you are in stage 3 of clinical trials
for some of these products. Please revise future filings to disclose the costs incurred
during each period presented for each of your key research and development
products/projects. If you do not track your research and development costs by project,
disclose that fact and explain why you do not maintain and evaluate research and
development costs by project. Provide other quantitative or qualitative disclosure that
provides more transparency as to the type of research and development expenses incurred
(i.e., by nature or type of expense) which should reconcile to total research and
development expenses on the Consolidated Statements of Operations.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
You may contact Tara Harkins at (202) 551-3639 or Dan Gordon, Reviewing
Accountant, at (202) 551-3486 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2020-05-01 - CORRESP - FILANA THERAPEUTICS, INC.
CORRESP 1 filename1.htm Correspondence May 1, 2020 VIA EDGAR Division of Corporation Finance Office of Life Sciences United States Securities and Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attention: Jeffrey Gabor Re: Cassava Sciences, Inc. Registration Statement on Form S-3 File No. 333-237452 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Cassava Sciences, Inc. (the “Registrant”) hereby requests acceleration of effectiveness of its registration statement on Form S-3 (File No. 333-237452) to 4:00 p.m., Eastern Time, on May 5, 2020, or as soon as practicable thereafter. The Registrant requests that it be notified of such effectiveness by contacting Alfredo B. D. Silva, the Company’s counsel at Morrison & Foerster LLP, at (415) 268-6213 or asilva@mofo.com. Very truly yours, Cassava Sciences, Inc. By: /s/ Remi Barbier Name: Remi Barbier Title: Chief Executive Officer
2020-04-09 - CORRESP - FILANA THERAPEUTICS, INC.
CORRESP 1 filename1.htm S-3A -Cassava SEC Response Letter 415.268.7000 Facsimile: 415.268.7522 boston, brussels, denver, hong kong, london, los angeles, new york, northern virginia, palo alto, san diego, san francisco, shanghai, singapore, tokyo, washington, d.c. 425 Market Street San Francisco California 94105-2482 Telephone: 415.268.7000 Facsimile: 415.268.7522 www.mofo.com morrison & foerster llp beijing, berlin, boston, brussels, denver, hong kong, london, los angeles, new york, northern virginia, palo alto, san diego, san francisco, shanghai, singapore, tokyo, washington, d.c. April 9, 2020 Jeffrey Gabor Attorney Advisor Division of Corporation Finance Office of Life Sciences Securities and Exchange Commission 100 F Street, N.E. Mail Stop 3030 Washington, D.C. 20549 Re: Cassava Sciences, Inc. Registration Statement on Form S-3 Filed March 27, 2020 File No. 333-237452 Dear Mr. Jeffrey Gabor: On behalf of Cassava Sciences, Inc. (the “Company”), we submit this letter providing responses to the comments raised by the Staff of the Securities and Exchange Commission (the “Staff”) in its letter dated April 2, 2020, with respect to the registration statement on Form S-3 (File No. 333-237452), as amended (the “Registration Statement”). Below we have noted the Staff’s comments in bold face type and the Company’s responses in regular type. Units 1.If you plan to offer units, please revise the registration statement fee table and prospectus cover page to identify the units as securities in the offering, identifying the components of the units. Please also include disclosure regarding the units you are registering. Jeffrey Gabor April 9, 2020 Page 2 Response: In response to the Staff’s comment, we have filed an S-3/A revising the registration statement fee table and prospectus cover page. We have also included disclosure regarding the units in the prospectus. Legality Opinion 2.Your legality opinion should address the legality of the depositary shares being offered. Response: In response to the Staff’s comment, we have filed a new opinion as Exhibit 5.1 which addresses the legality of depositary shares being offered. Jeffrey Gabor April 9, 2020 Page 3 We appreciate your time and attention to this Amendment No. 1, as well as to the Company’s responses to the Staff’s comments. Should you have any additional questions or concerns, please call me at (415) 268-6213. Sincerely, /s/ Alfredo B.D. Silva Alfredo B.D. Silva cc: Celeste Murphy (Division of Corporate Finance) Eric J. Schoen (Cassava Sciences, Inc.)
2020-04-02 - UPLOAD - FILANA THERAPEUTICS, INC.
April 2, 2020
Remi Barbier
Chief Executive Officer
Cassava Sciences, Inc.
7801 N Capital of Texas Highway, Suite 260
Austin, TX 78731
Re:Cassava Sciences, Inc.
Registration Statement on Form S-3
Filed March 27, 2020
File No. 333-237452
Dear Mr. Barbier:
We have limited our review of your registration statement to those issues we have
addressed in our comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to this comment, we may have additional comments.
Registration Statement on Form S-3 filed March 27, 2020
Cover Page
1.If you plan to offer units, please revise the registration statement fee table and prospectus
cover page to identify the units as securities in the offering, identifying the components of
the units. Please also include disclosure regarding the units you are registering. Lastly,
your legality opinion should address the legality of the depositary shares being offered.
Please refer to Staff Legal Bulletin No. 19.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
FirstName LastNameRemi Barbier
Comapany NameCassava Sciences, Inc.
April 2, 2020 Page 2
FirstName LastName
Remi Barbier
Cassava Sciences, Inc.
April 2, 2020
Page 2
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Jeffrey Gabor at 202-551-2544 or Celeste Murphy at 202-551-3257 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Alfredo B. D. Silva, Esq.
2019-01-28 - CORRESP - FILANA THERAPEUTICS, INC.
CORRESP 1 filename1.htm Acceleration Request 012819 Pain Therapeutics, Inc. January 28, 2019 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attention:Donald E. Field Re:Pain Therapeutics, Inc. (the “Company”) Registration Statement on Form S-1 Originally Filed December 18, 2018 Ladies and Gentlemen: The Company hereby requests acceleration of the effective date of its Registration Statement on Form S-1, as amended (the “Securities Act”), to 4:00pm, Eastern time, on January 30, 2019 or as soon thereafter as possible. The Company hereby acknowledges its responsibilities under the Securities Act and the Exchange Act as they relate to the proposed public offering of the securities specified in the above-referenced Registration Statement. Please call Michael J. O’Donnell of Morrison & Foerster LLP, special counsel to the Company, at (650) 813-5977 as soon as the Registration Statement has been declared effective. Very truly yours, PAIN THERAPEUTICS, INC. By: /s/ Remi Barbier Name: Remi Barbier Its: President and Chief Executive Officer
2018-12-21 - UPLOAD - FILANA THERAPEUTICS, INC.
December 21, 2018
Remi Barbier
Chief Executive Officer
Pain Therapeutics, Inc.
7801 N. Capital of Texas Highway, Suite 260
Austin, TX 78731
Re:Pain Therapeutics, Inc.
Registration Statement on Form S-1
Filed December 18, 2018
File No. 333-228883
Dear Mr. Barbier:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Donald Field at 202-551-3680 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2017-04-25 - UPLOAD - FILANA THERAPEUTICS, INC.
Mail Stop 4546 April 25 , 2017 Remi Barbier President, Chief Executive Officer and Chairman Pain Therapeutics, Inc. 7801 N Capital of Texas Highway, Suite 260 Austin, TX 78731 Re: Pain Therapeutics, Inc. Registration Statement on Form S-3 Filed April 14 , 2017 File No. 333-217319 Dear Mr. Barbier : This is to advise you that we have not reviewed and will not review your registration statement . Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Christine Westbrook at (202) 551 -5019 with any questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Ze’-ev D. Eiger , Esq. Morrison & Foerster LLP
2010-02-19 - UPLOAD - FILANA THERAPEUTICS, INC.
Mail Stop 4720 February 19, 2010 Remi Barbier President, Chief Executive Officer and Director Pain Therapeutics, Inc. 2211 Bridgepointe Parkway, Suite 500 San Mateo, CA 94404 Re: Pain Therapeutics, Inc. Registration Statement on Form S-3 Filed February 2, 2010 File No. 333-164648 Dear Mr. Barbier: We have limited our review of your filing to those issues we have addressed in our comments. Where indicated, we think you should revise your document in response to these comments. If you disagree, we w ill consider your explanation as to why our comment is inapplicable or a revision is unneces sary. Please be as detailed as necessary in your explanation. In some of our comme nts, we may ask you to provide us with information so we may better understand your disclosure. After reviewing this 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. Information Incorporated by Reference, page 32 1. Please revise this section to incorporate by reference the Form 8-Ks filed by Pain Therapeutics since the end of the company’s last fiscal year. See Item 12(a)(2) of Form S-3. * * * Remi Barbier Pain Therapeutics, Inc. February 19, 2010 Page 2 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. Notwithstanding our comments, in the ev ent the company requests acceleration of the effective date of the pending registration statement, it should furnish a letter, at the time of such request, acknowledging that: • should the Commission or the staff, acting purs uant to delegated authority, declare the filing effective, it does not foreclose th e Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the company may not assert staff comments a nd the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. 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 460 and 461 regarding requesting acceleration of a registration statement. Please allow ad equate time after the filing of any amendment Remi Barbier Pain Therapeutics, Inc. February 19, 2010 Page 3 for further review before submitting a request for acceleration. Please provide this request at least two business days in a dvance of the requested effective date. Please contact Nandini Ac harya at (202) 551-3495 or me at (202) 551-3715 with any questions. S i n c e r e l y , J e f f r e y P . R i e d l e r A s s i s t a n t D i r e c t o r cc: Michael J. O’Donnell, Esq. Wilson Sonsini Goodrich & Rosati 650 Page Mill Road Palo Alto, CA 94304
2010-01-26 - UPLOAD - FILANA THERAPEUTICS, INC.
Via Facsimile and U.S. Mail Mail Stop 4720 January 26, 2010 Peter S. Roddy Vice President and Chief Financial Officer Pain Therapeutics, Inc. 2211 Bridgepointe Parkway Suite 500 San Mateo, CA 944404 Re: Pain Therapeutics, Inc. Form 10-K for Fiscal Year Ended December 31, 2008 Filed February 13, 2009 Schedule 14A Filed April 06, 2009 File No. 000-29959 Dear Mr. Roddy: We have completed our review of your Form 10-K and Schedule 14A and have no further comments at this time. S i n c e r e l y , J o e l P a r k e r A c c o u n t i n g B r a n c h C h i e f
2009-12-18 - CORRESP - FILANA THERAPEUTICS, INC.
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Correspondence Letter
December 18, 2009
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, N.E.
Mail Stop 4720
Washington, D.C. 20549
Attention:
Suzanne Hayes
Jeffrey P. Riedler
Re:
Pain Therapeutics, Inc.
Form 10-K filed for the Year Ended December 31, 2008
Filed February 13, 2009
File No. 000-29959
Dear Ms. Hayes:
Pain Therapeutics, Inc. (the “Company”) provides this response to the comments of the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) contained in the Staff’s letter dated December 14, 2009 (the “Staff Letter”), relating to the above-referenced Form 10-K filed by the Company.
In response to the Staff’s comments, we have reproduced below the comments set forth in the Staff Letter and followed each comment with our response. The numbered paragraphs of this letter set forth below correspond to the numbered paragraphs
of the Staff Letter. References to “we,” “our” or “us” mean the Company or its advisors, as the context may require.
Form 10-K, filed 02/13/2009
Intellectual Property, page 5
COMMENT 1: We note your response to comment 1. Please confirm that you intend to provide this information in your
“Intellectual Property” discussion in your next 10-K.
RESPONSE: We hereby confirm that we will
provide the information included in our letter dated December 4, 2009 in response to the SEC’s Comment 1 in our next Annual Report on Form 10-K for the fiscal year ending December 31, 2009.
Schedule 14A, filed 04/06/2009
Compensation Discussion and Analysis, page 11
COMMENT 2: To the extent you
continue to state that you use purchased surveys and/or internally generated surveys for determining compensation, please confirm that you will indentify the purchased surveys and identify the companies included in your internally generated surveys
and explain how you used the data generated from these surveys.
RESPONSE: We hereby confirm that to
the extent we continue to state that we use purchased surveys and/or internally generated surveys for determining compensation, we will identify the purchased surveys and identify the companies included in our internally generated surveys and
explain how we used the data generated from these surveys.
U.S. Securities and Exchange Commission
December 18, 2009
Page 2
Should you have any further questions or comments, please do not hesitate to contact me at (650) 645-1930.
Sincerely,
Pain Therapeutics, Inc.
/s/ Peter S. Roddy
Peter S. Roddy
Vice President and Chief Financial Officer
cc:
Michael O’Donnell, Esq.
Gavin McCraley, Esq.
Wilson Sonsini Goodrich & Rosati, P.C.
2009-12-14 - UPLOAD - FILANA THERAPEUTICS, INC.
Via Facsimile and U.S. Mail
Mail Stop 4720
December 14, 2009
Peter S. Roddy
Vice President and Chief Financial Officer
2211 Bridgepointe Parkway
Suite 500
San Mateo, CA
Re: Pain Therapeutics, Inc.
Form 10-K for the Year Ended December 30, 2009
Filed February 13, 2009
File Number: 000-29959
Dear Mr. Roddy:
We have reviewed your response dated December 4, 2009 to our November 9,
2009 letter and have the following comments. In our comments, we may ask you to
provide us with information to better unde rstand your disclosure. Where a comment
requests you to revise disclosure, the info rmation you provide should show us what the
revised disclosure will look like. Please identify the annual or quarterly filing, as
applicable, in which you intend to first incl ude it. If you do not believe that revised
disclosure is necessary, e xplain the reason in your res ponse. After reviewing the
information provided, we may raise additiona l comments and/or request that you amend
the above filings.
Form 10-K
Intellectual Property, page 5
1. We note your response to comment 1. Pl ease confirm that you intend to provide
this information in your “I ntellectual Property” disc ussion in your next 10-K.
Schedule 14A
Compensation Discussion and Analysis, page 11
2. To the extent you continue to state th at you use purchased surveys and / or
internally generated surveys for determ ining compensation, please confirm that
you will identify the purchased surveys a nd identify the companies included in
Peter S. Roddy
Pain Therapeutics, Inc. December 14, 2009 Page 2
your internally generated surveys and e xplain how you used the data generated
from these surveys.
* * * *
Please provide us the information request ed within 10 busine ss days or tell us
when you will provide us with a response. Pl ease furnish a cover le tter with your response
that keys your response to our comment. De tailed cover letters gr eatly facilitate our
review. Please furnish your letter on EDGAR under the form type label CORRESP.
Please contact Suzanne Hayes Legal Bran ch Chief, at (202) 551-3675 or me at
(202) 551-3715 with any questions. S i n c e r e l y , J e f f r e y P . R i e d l e r A s s i s t a n t D i r e c t o r
2009-12-04 - CORRESP - FILANA THERAPEUTICS, INC.
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Correspondence
December 4, 2009
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, N.E.
Mail Stop 4720
Washington, D.C. 20549
Attention:
Nu Ri Jung
Suzanne Hayes
Jeffrey P. Riedler
Re:
Pain Therapeutics, Inc.
Form 10-K filed for the Year Ended December 31, 2008
Filed February 13, 2009
File No. 000-29959
Ladies and Gentlemen:
Pain Therapeutics, Inc. (the “Company”) provides this response to the
comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in the Staff’s letter dated November 9, 2009 (the “Staff Letter”), relating to
the above-referenced Form 10-K filed by the Company. In response to the Staff’s comments, we have reproduced below the comments set forth in the Staff Letter and followed each comment with our response. The numbered paragraphs of this letter
set forth below correspond to the numbered paragraphs of the Staff Letter. References to “we,” “our” or “us” mean the Company or its advisors, as the context may require.
In addition, as requested by the Staff Letter, please note that the Company hereby acknowledges that:
•
the Company is responsible for the adequacy and accuracy of the disclosure in the filings;
•
Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the
filings; and
•
the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of
the United States.
Form 10-K, filed 02/13/2009
Item 1. Business, page 2
Intellectual Property, page 5
COMMENT 1: Please identify all of your material
patents and all the material patents you license from third parties. Additionally, disclose your product candidates that are dependent on each patent and disclose when each patent expires.
U.S. Securities and Exchange Commission
December 4, 2009
Page
2
RESPONSE: Our material patents and all the material patents we license from third parties include the following:
•
For Remoxy and our other abuse resistant product candidates, we have licensed from Durect Corporation U.S. Patent 5,747,058, titled “High
Viscosity Liquid Controlled Delivery System.” Such patent expires in June 2015.
•
For melanoma, we have licensed from Albert Einstein College of Medicine U.S. Patent No. 7,402,385, titled “Radiolabled Anti-Melanin
Antibodies and Peptides for Treatment of Melanoma.” Such patent expires in April 2024.
•
For hemophilia, we have licensed from Poetic Genetics, LLC U.S. Patent No. 7,361,641, titled “Methods and Compositions for Genomic
Modification.” Such patent expires in August 2019.
Other patents have published but not issued and
other patent applications are pending.
Strategic Alliance with King Pharmaceuticals, Inc., page 5
COMMENT 2: Please revise your disclosure regarding the collaboration agreement and the license agreement with King to
disclose when the latest to expire patent is scheduled to expire.
RESPONSE: We propose to revise the last
paragraph under the heading “Strategic Alliance with King Pharmaceuticals, Inc.” to include the requested disclosure as follows:
“The collaboration agreement continues until the later of the expiration of any patent rights licensed under the license agreement or developed under the collaboration agreement and the expiration of
all periods of market exclusivity with respect to Remoxy and other abuse-resistant opioid drug candidates being developed under the strategic alliance. Currently, the last to expire issued patent covered by such arrangement expires in June 2016;
however, we expect such date may be extended by the issuance of any additional patents pursuant to pending patent applications. We and King can terminate the collaboration agreement under certain circumstances, including material breach and
insolvency. Our license agreement with King terminates at the time that the collaboration agreement terminates.”
We
propose to include this revised disclosure in our next Annual Report on Form 10-K filed for the fiscal year ending December 31, 2009 (the “Next 10-K”).
Formulation Agreement with Durect Corporation, page 6
COMMENT 3: Please revise your disclosure to disclose all the material terms of this agreement, including, but not limited to, amounts paid to date, aggregate potential milestone payments, the range of potential royalty
payments (i.e. “low single digits” or “high single digits”), and term and termination provisions.
U.S. Securities and Exchange Commission
December 4, 2009
Page
3
RESPONSE: We propose to revise the disclosure under the heading “Formulation Agreement with Durect Corporation” to include the requested disclosure as follows:
“We have an exclusive, worldwide Development and License Agreement, or the Durect Agreement, with Durect Corporation, or
Durect, to use a patented technology that forms the basis for a number of oral gel-cap drug candidates, including Remoxy. We reimburse Durect for formulation and related work, and make milestone payments based on the achievement of certain
technical, clinical or regulatory milestones. Aggregate payments to Durect from the inception of the Durect Agreement to December 31, 2008 were approximately $34.1 million. We paid Durect $1.0 million in upfront payments under the Durect
Agreement and $1.7 million in milestones for achievement of certain clinical and regulatory milestones. We could pay up to another $7.6 million of potential milestone payments under the Durect Agreement following achievement of certain clinical and
regulatory milestones. We have sub-licensed to King certain rights to develop and to commercialize Remoxy and certain other opioid drugs formulated in part with technology we licensed from Durect. King controls preclinical, clinical, commercial
manufacturing and sales and marketing activities for Remoxy and we control all of the preclinical, clinical, commercial manufacturing and sales and marketing activities the other abuse-resistant opioid painkillers. King is obligated to reimburse us
for all expenses for formulation and related work and for milestone payments we incur under our agreement with Durect.
We also are obligated to pay Durect royalties on any related drug sales. Royalties on sales of products licensed under our agreement with Durect range from 6.0% to 11.5%, depending on the level of sales of licensed products in a given
calendar year. In turn, King is obligated to reimburse us for all royalty expenses we incur under the agreement with Durect for product sales under our strategic allicance with King. Durect is obligated to supply King with certain components of
Remoxy and other abuse-resistant opioid painkillers pursuant to a commercial supply agreement between King and Durect.
The Durect Agreement terminates on a country-by-country basis upon the later of the expiration of the last to expire of the patents licensed under such agreement or a certain number of years following first commercial sale in such country.
Currently, the last to expire patent covered by such agreement expires in June 2016: however, we expect such date may be extended by the issuance of any additional patents pursuant to pending patent applications. We can terminate the Durect
Agreement with notice to Durect and we and Durect can terminate such agreement under certain circumstances, including material breach and insolvency.
Under our license agreement with King, we are obligated not to amend or terminate our agreement with Durect if an amendment or termination would alter the rights or obligations of King under our
collaboration agreement or license agreement with King.”
We propose to include this revised disclosure in the Next 10-K.
The figures given for payments to Durect Corporation in the above proposed language are as of December 31, 2008, but such figures will be updated to December 31, 2009 in the corresponding disclosure we provide in the Next 10-K.
License of Technology from Albert Einstein College of Medicine, page 6
COMMENT 4: Please provide a more specific description of the technology you license from Albert Einstein College of Medicine
and identify your product candidates that are dependent on this technology. Additionally, file the agreement as an exhibit and disclose all the material terms of this agreement, including but not limited to quantify the payments made to date,
aggregate potential milestone payments, the range of royalty payments (i.e. “low single digits” or “high single digits”), and term and termination provisions. If you believe you are no longer substantially dependent on
this agreement, please provide us with an analysis supporting you determination.
U.S. Securities and Exchange Commission
December 4, 2009
Page
4
RESPONSE: We propose to revise the disclosure under the heading “License of Technology from Albert Einstein College of Medicine” to include the requested disclosure as follows:
“We have licensed certain technology, including technology that we use in our monoclonal antibody program for the
treatment of metastatic melanoma, from Albert Einstein College of Medicine, or AECOM, pursuant to a License Agreement, or AECOM Agreement. Under the AECOM Agreement, we have a worldwide exclusive license to the technology underlying the AECOM
Agreement and all intellectual property rights arising from such technology. The AECOM Agreement requires us to pay AECOM up to $8 million in milestone payments, based on certain clinical development and commercial milestones, and royalties of 4%
based on sales of licensed products. If a product utilizing technology licensed under the AECOM Agreement is combined with a drug or other substance for which we are paying an additional royalty, the royalty that we pay to AECOM will be reduced by
up to one-half based on the amount of such additional royalty. In connection with the AECOM Agreement, we also issued a warrant to purchase up to 150,000 shares of our common stock at an exercise price of $6.77 per share, with vesting subject to
certain commercial milestones. This warrant expired unvested in January 2010. Aggregate payments to AECOM from the inception of the AECOM Agreement to December 31, 2008 were approximately $1.3 million, inclusive of an up-front payment of
$200,000. We have not yet made any milestone payments to AECOM under this agreement.
The AECOM Agreement
terminates on a country-by-country basis when our obligation to pay royalties ceases. All royalty obligations will cease upon the expiration of the last to expire patent covered by the agreement. Currently, the last to expire patent covered by such
agreement expires in April 2024; however, we expect such date may be extended by the issuance of any additional patents pursuant to pending patent applications. We can terminate this license anytime and we and AECOM can terminate under certain
circumstances, including material breach and insolvency.
AECOM originally received grants from the U.S.
federal government to research some of the technology that we license. The terms of these grants provide the U.S. federal government with a non-exclusive, non-transferable paid-up license to practice inventions made with federal funds. Thus, our
licenses are non-exclusive to the extent of the U.S. federal government’s license. If the U.S. federal government exercises its rights under this license, it could make use of the same technology that we license and the size of our potential
market could thereby be reduced.”
We propose to include this revised disclosure in the Next 10-K. The figures given for
payments to the Albert Einstein College of Medicine (“AECOM”) in the above proposed language are as of December 31, 2008, but such figures will be updated to December 31, 2009 in the corresponding disclosure we provide in the
Next 10-K.
We do not believe that our business is substantially dependent on the License Agreement with AECOM (the
“AECOM Agreement”) within the meaning of Item 601(b)(10)(ii)(B) of Regulation S-K, and, as a result, have not filed such agreement with our periodic reports with the Commission. The technology associated with the AECOM Agreement is
currently in the very early stages of research and
U.S. Securities and Exchange Commission
December 4, 2009
Page
5
development, having completed enrollment in only one Phase I clinical trial outside the U.S. and remaining subject to ongoing pre-clinical investigation. As a result, we do not yet receive any
revenues from products utilizing this technology, and our ability to identify, develop and commercialize products covered by the AECOM Agreement, or generate revenue therefrom, is subject to substantial risk and not currently ascertainable.
Moreover, we have a pipeline of other development programs and product candidates that we are pursuing, and our business is therefore not dependent on the success of any development candidates we may identify under the AECOM Agreement technology.
License of Technology from Poetic Genetics, LLC, page 7
COMMENT 5: Please revise your disclosure to provide a description of all the material terms of the license agreement with
Poetic, including, not limited to payments made to date and term and termination provisions. In addition, please file a copy of the agreement as an exhibit. Alternatively, please provide us with a detailed analysis which supports your conclusion
that you are not required to file this agreement pursuant to Item 601(b)(10)(ii)(B) of Regulation S-K.
RESPONSE: We propose to revise the disclosure under the heading “License of Technology from Poetic Genetics, LLC” to include the requested disclosure as follows:
“We have licensed novel gene integration technology from Poetic pursuant to a License Agreement with Poetic, or the
Poetic License. We have worldwide commercial rights and all intellectual property rights arising from the technology subject to the Poetic License in all indications in hemophilia and pain management. In connection with the Poetic License, we paid
Poetic a $10,000 upfront fee and also issued a warrant to purchase up to 300,000 shares of our common stock at an exercise price of $8.86 per share that does not vest until certain commercialization milestones are met with respect to products
relying on technology licensed under the agreement. This warrant is not currently vested and terminates in February 2027. Under the Poetic License, we are also obliged to pay Poetic milestone payments of up to $4 million in the aggregate, based on
clinical and regulatory progress, and a royalty on net sales in the mid-single digit range. Other than the up-front payment, we have not to date made any other cash payments to Poetic under this agreement.
The Poetic License terminates on a country-by-country basis on the expiration of the last patent licensed under the agreement
or, if there is no valid claim under a licensed patent, seven years from the first commercial sale of a licensed product. Currently, the last to expire patent covered by such agreement expires in August 2019; however, we expect such date may be
extended by the issuance of any additional patents pursuant to pending patent applications. The Poetic License is also terminable by either us or Poetic in the event of a material breach by the other party.”
We propose to include this revised disclosure in the Next 10-K.
We do not believe that our business is substantially dependent on the License Agreement with Poetic Genetics, LLC (the “Poetic
License”) within the meaning of Item 601(b)(10)(ii)(B) of Regulation S-K, and, as a result, have not filed such agreement with our periodic reports with the Commission. The technology associated with the Poetic License is currently in the
very early stages of research, and is currently being investigated in pre-clinical
2009-11-25 - CORRESP - FILANA THERAPEUTICS, INC.
CORRESP 1 filename1.htm Correspondence November 25, 2009 VIA EDGAR AND FACSIMILE (202) 772-9198 Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Jeffrey P. Riedler Suzanne Hayes Nu Ri Jung Re: Pain Therapeutics, Inc. Form 10-K for the fiscal year ended December 31, 2008 Filed February 13, 2009 Dear Mr. Riedler, Ms. Hayes and Ms. Jung: On behalf of Pain Therapeutics, Inc. (the “Company”), this letter is being submitted in reference to the Securities and Exchange Commission’s (the “Commission”) letter to Peter S. Roddy, Vice President and Chief Financial Officer of the Company, dated November 9, 2009 (the “Comment Letter”). The Company is working expeditiously to respond to the Comment Letter. However, in order to fully address the comments from the staff of the Commission (the “Staff”) and to allow the Company an opportunity to comply with the confidentiality provisions of contracts with third parties as to which the Staff has asked the Company to provide further disclosure of terms that are not currently in the public domain, the Company respectfully requests an extension of time to respond to the inquiries contained in the Comment Letter. The Company currently anticipates submitting a response to the Comment Letter on or before December 4, 2009. Please do not hesitate to contact me (650-565-3854) or Peter Roddy, the Company’s Vice President and Chief Financial Officer (650-645-1930), with any concerns you may have regarding the timetable described above. Thank you for your consideration. Sincerely, WILSON SONSINI GOODRICH & ROSATI Professional Corporation /s/ Gavin McCraley Gavin McCraley cc: Peter S. Roddy Pain Therapeutics, Inc. Michael O’Donnell, Esq. Wilson Sonsini Goodrich & Rosati, Professional Corporation
2009-11-09 - UPLOAD - FILANA THERAPEUTICS, INC.
Via Facsimile and U.S. Mail Mail Stop 4720 November 9, 2009 Mr. Peter S. Roddy Vice President and Chief Financial Officer 2211 Bridgepointe Parkway Suite 500 San Mateo, CA 94404 Re: Pain Therapeutics, Inc. Form 10-K for the Year Ended December 31, 2008 Filed February 13, 2009 File No. 000-29959 Dear Mr. Roddy: We have reviewed your filing and have the following comments. In our comments, we ask you to provide us with information to better understand your disclosure. Where it requests you to revi se disclosure, the information you provide should show us what the revised disclosure will look like and identify the annual or quarterly filing, as applicable, in which you inte nd to first include it. If you do not believe that revised disclosure is n ecessary, explain the reason in your response. After reviewing the information provided, we may raise a dditional comments and/or request that you amend your filing. 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 on any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. Form 10-K, filed 02/13/2009 Item 1. Business, page 2 Intellectual Property, page 5 Mr. Peter S. Roddy Pain Therapeutics, Inc. November 9, 2009 Page 2 1. Please identify all of your material patent s and all the material patents you license from third parties. Additionally, di sclose your product candidates that are dependent on each patent and disclose when each patent expires. Strategic Alliance with King Pharmaceuticals, Inc., page 5 2. Please revise your disclosure regardi ng the collaboration agreement and the license agreement with King to disclose when the latest to expire patent is scheduled to expire. Formulation Agreement with Durect Corporation, page 6 3. Please revise your disclosure to disclose a ll the material terms of this agreement, including, but not limited to, amounts paid to date, aggregate potential milestone payments, the range of potential royalty payments (i.e. “low single digits” or “high single digits”), and term and termination provisions. License of Technology from Albert Eins tein College of Medicine, page 6 4. Please provide a more specific descrip tion of the technology you license from Albert Einstein College of Medicine and identify your product candidates that are dependent on this technology. Additionall y, file the agreement as an exhibit and disclose all the material terms of this agreement, including but not limited to quantify the payments made to date, aggr egate potential milestone payments, the range of royalty payments (i.e. “low si ngle digits” or “high single digits”), and term and termination provisions. If you believe you are no longer substantially dependent on this agreement, please provi de us with an analysis supporting your determination. License of Technology from Poetic Genetics, LLC, page 7 5. Please revise your disclosure to provide a description of all the material terms of the license agreement with Poetic, incl uding, not limited to payments made to date and term and termination provisions. In addition, please f ile a copy of the agreement as an exhibit. Alternatively, please provide us with a detailed analysis which supports your conclusion that you are not required to file this agreement pursuant to Item 601(b)(10)(ii)(B) of Regulation S-K. Schedule 14A, filed 04/06/2009 Executive Compensation and Other Matters, page 11 Compensation Discussion and Analysis, page 11 Mr. Peter S. Roddy Pain Therapeutics, Inc. November 9, 2009 Page 3 6. On page 11, you state that your compensation committee uses surveys purchased from third parties and internally genera ted to determine the amount and allocation of compensation. Please identify the su rveys purchased from third parties and identify the companies included in your in ternally generated survey. It appears from your statement on page 12 that you use a review of the surveys in determining a bonus for the year that you use the surveys for benchmarking purposes. See Question 118.05 of the Regul ation S-K Compliance & Disclosure Interpretations. Additionally, further explain how these surveys were used. For example, if based on the surveys you decided to adjust the amounts of compensation or the allocation, pl ease provide further explanation. Elements of Executive Compensation, page 11 Bonuses, page 12 7. On page 12, you state that “Each individua l is evaluated to determine a bonus for the prior year based on performance criteria, including, among other criteria, progress towards or achievement of clinical, operationa l and financial goals as applicable within an executive’s ar ea of responsibility.” Based on your disclosure, it appears that your executive officers have received bonus payments based in part of these performance crit eria. Please provide proposed draft disclosure for your 2010 proxy statement providing a more specific discussion of the milestones, clinical, operational and financial goals for each individual’s area of responsibility for each named executive offi cer. To the extent that the goals or milestones were quantified, your disclosu re should also be quantified. In addition, confirm that your 2010 proxy statement will discuss the extent to which these goals were achieved and how the level of achievement was used to determine each named execu tive officer’s bonus. 8. We note that you paid bonuses to Mr. Ba rbier, Dr. Friedmann, Mr. Roddy and Dr. Schoenhard in 2008. Additionally, your compensation table on page 16 includes these bonuses as “paid or accrued during fiscal year 2008.” It is unclear whether these bonuses were earned in 2008 or 2007. Item 402(c)(2)(iv) if Regulation S-K requires disclosure of bonuses earned during the 2008. Please clarify whether the named executive officers earned bonuses in 2008. Other Equity Awards, page 13 9. Please file a copy of the Long-Term Incenti ve Plan, or LTIP, as an exhibit. Alternatively, please provide us with a detailed analysis which supports your conclusion that you are not required to f ile this compensatory plan pursuant to Item 601(b)(10)(iii)(A) of Regulation S-K. * * * * Mr. Peter S. Roddy Pain Therapeutics, Inc. November 9, 2009 Page 4 Please respond to these comments within 10 business days or tell us when you will provide us with a response. Please furnish a cover letter that keys your responses to our comments and provide any requested information. Detailed letter s greatly facilitate our review. Please file y our letter on EDGAR under the form type label CORRESP. 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 Exchange Act of 1934 and th at they have provided all information investors require for an informed invest ment decision. Since the company and its management are in possession of all facts re lating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In connection with responding to our co mments, please provide, in your letter, a statement from the company acknowledging that: • the company is responsible for the adequacy and accuracy of the disclosure in the filing; • staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and • the company may not assert staff comme nts as a defense in any proceeding initiated by the Commission or any person under the federal secu rities laws of the United States. In addition, please be advise d that the Division of Enfo rcement has access to all information you provide to the staff of the Divi sion of Corporation Fi nance in our review of your filing or in response to our comment on your filing. Please contact Nu Ri Jung at (202) 551-5797, Suzanne Hayes at (202) 551-3675 or me at (202) 551-3715 with any questions. Sincerely, Jeffrey P. Riedler Assistant Director
2006-10-24 - UPLOAD - FILANA THERAPEUTICS, INC.
Via Facsimile and U.S. Mail Mail Stop 6010 July 6, 2006
Mr. Peter S. Roddy Chief Financial Officer Pain Therapeutics, Inc. 416 Browning Way San Francisco, CA 94080
Re: Pain Therapeutics, Inc.
Form 10-K for the year ended December 31, 2005
Filed February 24, 2006
File No. 000-29959
Dear Mr. Roddy:
We have completed our review of your Form 10-K and have no further comments
at this time.
S i n c e r e l y ,
K e v i n W o o d y B r a n c h C h i e f
2006-06-22 - CORRESP - FILANA THERAPEUTICS, INC.
CORRESP 1 filename1.htm Response Letter June 22, 2006 Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: James Rosenberg, Senior Assistant Chief Accountant Kevin Woody, Branch Chief Christine Allen, Staff Accountant Re: Pain Therapeutics, Inc. Form 10-K for the fiscal year ended December 31, 2005 File No. 000-29959 Dear Messrs. Rosenberg and Woody and Ms. Allen: On behalf of Pain Therapeutics, Inc. (the “Company”), this letter responds to the follow-up comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) to the filing of the above-referenced Annual Report on Form 10-K for the fiscal year ended December 31, 2005 (the “Form 10-K”), which were communicated in the course of our conference telephone call with the Staff on June 16, 2006 at about 1:00 p.m. EDT (the “Staff Call”). In response to the comments from the Staff Call, we have retained the text of the original comments (the “Original Comments”) from the Staff’s Comment Letter dated May 22, 2006 (the “Staff Letter”) and have followed each comment with our responses as discussed during the Staff Call. The numbered paragraphs of this letter set forth below correspond to the numbered paragraphs of the Staff Letter. References to “we,” “our” or “us” mean the Company or its advisors, as the context may require. Our responses to the comments set forth in the Staff Letter as discussed on the Staff Call are as follows: Item 7. Management’s Discussion and Analysis Overview, page 27 1. We note from disclosures that your technology has been applied across your portfolio of drug candidates. Considering you have two projects (Remoxy and Oxytrex) well into phase III clinical trials and for which you are being reimbursed for development expenses, it appears you are able to track research and development cost by project James Rosenberg, Senior Assistant Chief Accountant Kevin Woody, Branch Chief Christine Allen, Staff Accountant Securities and Exchange Commission Division of Corporation Finance. Page 2 at a minimum from the phase III clinical trials stage. Please provide to us, in disclosure type format the following information for each of your major research and development projects or tell us why you are unable to give us this information considering the stage of your pipeline. a. The costs incurred from phase III clinical trials through the balance sheet date; b. The nature of the efforts necessary to complete the projects; c. A range of time and estimated costs of the efforts necessary to complete the projects. During the Staff Call, the Staff requested that we (i) provide in disclosure type format the estimated completion time of our development activities under our strategic alliance with King Pharmaceuticals, Inc. (“King”), and the basis for such estimate, and (ii) consider providing in future filings with the Commission disclosures, such as an example of the cross-application of our technologies, to allow investors to better understand our business and the rationale for our inability to disaggregate development costs on a drug-candidate by drug-candidate basis. We understand that the other aspects of Original Comment 1 from the Staff Letter were resolved to the satisfaction of the Staff during the course of the Staff Call. With respect to our estimation of the completion time of development activities under our strategic alliance with King, such matters are addressed below under our modified response to Original Comment 2 since this concept is linked to our disclosures regarding our revenue recognition policies. With respect to the latter request, we plan to include in our Quarterly Report on Form 10-Q for the period ended June 30, 2006 (the “Next 10-Q”) additional disclosures explaining the cross-application of our technology in order to further describe the nature of our business and illustrate the basis for our inability to disaggregate expenses across our franchise in the development of drugs for the treatment of pain. James Rosenberg, Senior Assistant Chief Accountant Kevin Woody, Branch Chief Christine Allen, Staff Accountant Securities and Exchange Commission Division of Corporation Finance. Page 3 Notes to Financial Statements, page 39 Summary of Significant Accounting Policies, page 39 Revenue Recognition and Deferred Program Fee Revenue, page 39 2. Please provide us, in disclosure-type format, the significant terms of the agreement between Pain Therapeutics and King Pharmaceuticals. Additionally, tell us how you have accounted for the transaction, including the basis for your revenue recognition policy, management’s analysis of separate units of accounting under EITF 00-21 and management’s justification of the period over which you anticipate recognizing revenue. In connection with the Staff Call, the Staff requested that we discuss and disclose additional information regarding our revenue recognition policies. Specifically, the Staff requested that we provide, in disclosure type format, (i) the period over which we recognize program fee revenue under our collaboration with King and the basis for determining such period, and (ii) how we will account for milestone payments under our collaboration with King, along with the basis for our revenue recognition policy for such milestone payments pursuant to the application of EITF Issue No. 00-21, “Revenue Arrangements with Multiple Deliverables” and other relevant guidance. We understand that the other aspects of Original Comment 2 from the Staff Letter were resolved to the satisfaction of the Staff during the course of the Staff Call. With respect to the first request (which also addresses the first item set forth in our discussion under Original Comment 1 above), we propose inserting in the Next 10-Q the following language into the footnotes to our financial statements, along with a summary of such disclosures in the “Management Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies” section: “Revenue Recognition and Deferred Program Fee Revenue We and King are engaged in a strategic alliance to develop and commercialize Remoxy and other abuse-resistant opioid painkillers. In connection with the strategic alliance, we have recognized program fee revenue and collaboration revenue. Program fee revenue is derived from the upfront payment from King and is recognized ratably over our estimate of the completion of the development period of the four drug candidates expected to be developed pursuant to the strategic alliance with King. Of those drug candidates, Remoxy is in Phase III James Rosenberg, Senior Assistant Chief Accountant Kevin Woody, Branch Chief Christine Allen, Staff Accountant Securities and Exchange Commission Division of Corporation Finance. Page 4 clinical trials and two potential drug candidates are under development at the pre-clinical stage. We have yet to initiate development on a fourth potential drug candidate under the strategic alliance. We currently estimate the development period for all four expected drug candidates to extend through July 2011. Collaboration revenues from reimbursement of development expenses are recognized as costs that relate to the strategic alliance with King are incurred.” With respect to the Staff’s second request as communicated in the Staff Call, we further propose inserting in the Next 10-Q (to the extent that we have not previously received milestones that would have been included in our financial statements for such period) the following language into the footnotes to our financial statements, along with a summary of such disclosures in the “Management Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies” section: “King is obligated to pay us up to $150 million in milestone payments contingent upon the achievement of certain substantive events in the clinical development of Remoxy and the other abuse-resistant opioid painkillers under the strategic alliance. We will recognize any milestone payments from King as revenue when we achieve the underlying developmental milestone as the milestone payments are not dependent upon any other future activities or achievement of any other future milestones, and the achievement of each of the developmental milestones was substantively at risk and contingent at the effective date of the strategic alliance. There will be substantial effort involved in achieving each of the developmental milestones. These milestones represent the culmination of discrete earnings processes and the amount of each milestone payment is reasonable in relation with the level of effort associated with the achievement of the milestone. Each milestone payment will be non-refundable and non-creditable when made. Further, the ongoing research and development services being provided to King under the strategic alliance are priced at fair value based upon the reimbursement of expenses incurred pursuant to the King collaboration.” We respectfully request that the Staff allow us to provide the above disclosures on a going forward basis, beginning with our Next 10-Q, and not require us to amend documents previously filed with the Commission. James Rosenberg, Senior Assistant Chief Accountant Kevin Woody, Branch Chief Christine Allen, Staff Accountant Securities and Exchange Commission Division of Corporation Finance. Page 5 Please acknowledge receipt of this letter and the enclosed materials by stamping the enclosed duplicate of this letter and returning it to the undersigned in the envelope provided. Any questions or additional comments you may have may be directed to me at (650) 565-3854 or Michael O’Donnell of our office at (650) 354-4178. Sincerely, Wilson Sonsini Goodrich & Rosati Professional Corporation /s/ Gavin McCraley Gavin McCraley cc: Peter Roddy Michael J. O’Donnell, Esq. Martin Waters, Esq.
2006-06-06 - CORRESP - FILANA THERAPEUTICS, INC.
CORRESP 1 filename1.htm Correspondence Letter June 6, 2006 Securities and Exchange Commission Division of Corporation Finance 450 Fifth Street, N.W. Washington, D.C. 20549 Attention: James Rosenberg, Senior Assistant Chief Accountant Re: Pain Therapeutics, Inc. Form 10-K for the fiscal year ended December 31, 2005 File No. 000-29959 Dear Mr. Rosenberg: On behalf of Pain Therapeutics, Inc. (the “Company”), this letter responds to the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) to the filing of the above-referenced Form 10-K for the fiscal year ended December 31, 2005 (the “Form 10-K”), which were furnished by your letter dated May 22, 2006 (the “Staff Letter”). In response to the comments set forth in the Staff Letter, we have reproduced below the comments set forth in the Staff Letter and have followed each comment with our response. The numbered paragraphs of this letter set forth below correspond to the numbered paragraphs of the Staff Letter. References to “we,” “our” or “us” mean the Company or its advisors, as the context may require. Our responses to the comments set forth in the Staff Letter are as follows: Item 7. Management’s Discussion and Analysis Overview, page 27 1. We note from disclosures that your technology has been applied across your portfolio of drug candidates. Considering you have two projects (Remoxy and Oxytrex) well into phase III clinical trials and for which you are being reimbursed for development expenses, it appears you are able to track research and development cost by project at a minimum from the phase III clinical trials stage. Please provide to us, in disclosure type format the following information for each of your major research and development projects or tell us why you are unable to give us this information considering the stage of your pipeline. James Rosenberg, Senior Assistant Chief Accountant Securities and Exchange Commission Division of Corporation Finance. Page 2 a. The costs incurred from phase III clinical trials through the balance sheet date; b. The nature of the efforts necessary to complete the projects; c. A range of time and estimated costs of the efforts necessary to complete the projects. With respect to the information requested by the Staff, we respectfully note that we revised our disclosures for our Annual Report on Form 10-K for the year ended December 31, 2003 in connection with comment letters from the Staff dated May 25, 2004 and June 18, 2004 on substantially similar matters, and that we have maintained and updated such disclosure in the Form 10-K on page 28. As discussed with the Staff previously, we believe that our current presentation of research and development expense better reflects the realities of how we conduct our business than the presentation suggested by the Staff in the comment. Substantially all of our research and development expenses relate to the development of opioid drugs for the treatment of severe chronic pain conditions. Our research and development involves technology licensed from Albert Einstein College of Medicine and formulation technology we access through the collaboration agreement with Durect Corporation. These technologies are applied across our existing drug candidates. As a result, data, know-how, personnel, clinical results, research results and other matters relating to the development of one of our drug candidates also relate to, and further the development of, the other drug candidates. Our accounting for research and development expenses tracks these realities of the manner in which we conduct our operations. For example, costs allocated to a specific drug candidate may not necessarily reflect the actual costs surrounding development of that drug candidate due to the cross-application of our development efforts. While it is true that we receive reimbursement under our strategic alliance with King Pharmaceuticals, Inc. (“King”) for the expenses directly incurred for our drug candidates that utilize technology we license from Durect, including Remoxy (the “Collaboration Candidates”), and not for Oxytrex, because of the shared technologies across our drug candidates, the funds we receive from King benefit all of our research and development efforts and inform the further development of current and potential drug candidates. Similarly, funds we expend on development of Oxytrex and other efforts outside of the Collaboration Candidates will inform and further the development of the Collaboration Candidates. Accordingly, we believe that disaggregating research and development efforts on a drug candidate-by-drug candidate basis would not accurately describe the manner in which we conduct our operations, and consequently, could be misleading to investors. James Rosenberg, Senior Assistant Chief Accountant Securities and Exchange Commission Division of Corporation Finance. Page 3 When discussing this matter with the Staff previously, the Staff acknowledged our concerns set forth above and suggested that we disclose the types of costs within our efforts directed towards the development of opioid drugs for the treatment of severe chronic pain instead of using a candidate-by-candidate disclosure. We agreed, and included the different types of costs suggested by the Staff in tabular format on page 28 of the Form 10-K. We feel that this disclosure is still the most appropriate format to follow since we were at the time of our last discussion with the Staff, as now, conducting phase III clinical development for Oxytrex. In addition, our entry into the strategic alliance with King does not change the matters previously discussed with the Staff, since the cross-application nature of our development efforts still remains the same. Furthermore, there is no way for us to judge whether we are, in fact, further along with our development efforts due to the risk associated with the drug development process, as discussed in more detail below. As a result, and in light of previous discussions with the Staff, we feel that changing our disclosure to one that focuses on development costs on a drug candidate-by-drug candidate basis could be misleading to investors since the nature of our development efforts remains the same as when this matter was last addressed with the Staff. In prior correspondence with the Staff, and specifically in response to Subsections b and c of the Staff’s comment, we also stated that the nature of the drug development business is that development of any drug candidate is subject to a great deal of risk and uncertainty due to, among other factors, the extended and uncertain development cycle necessitated by the clinical trial process and the complicated nature of the regulatory approval process. In light of this extreme uncertainty, we believe that any estimates relating to the future efforts necessary to complete development of any of our drug candidates, as well as any estimate of costs associated with completion of such development efforts, beyond what we have already disclosed publicly would be too speculative, and could mislead investors. Furthermore, the fact that the Company’s drug candidates are in phase III clinical trials does not reduce development risk associated with such drug candidates enough to allow us to go beyond the disclosures already provided. For example, the Company announced on November 22, 2005 that one of the phase III clinical trials for Oxytrex failed to reach its primary end-point. This clinical trial, therefore, cannot be used as the basis for us to submit a new drug application (“NDA”) with the U.S. Food and Drug Administration (“FDA”), and the Company must complete additional, and previously unforeseen, clinical trials in order to provide the basis for such an NDA. Another example is provided by the Company’s announcement on December 9, 2005 that the phase III clinical trial for its drug candidate PTI-901 failed to meet its primary end-point, and that, as a result, the James Rosenberg, Senior Assistant Chief Accountant Securities and Exchange Commission Division of Corporation Finance. Page 4 Company was ceasing all clinical development activities with respect to such drug candidate. We believe that these two examples illustrate that our reasons for being unable to disclose the information requested by the Staff in Subsections b and c above are valid, and that our current approach of disclosing the current status of each drug candidate and providing a discussion of the risks associated with the development of our drug candidates in the Management’s Discussion and Analysis of Financial Condition and Results of Operations and the Risk Factors sections of the Form 10-K, presents the best balance for providing meaningful information to investors. Notes to Financial Statements, page 39 Summary of Significant Accounting Policies, page 39 Revenue Recognition and Deferred Program Fee Revenue, page 39 2. Please provide us, in disclosure-type format, the significant terms of the agreement between Pain Therapeutics and King Pharmaceuticals. Additionally, tell us how you have accounted for the transaction, including the basis for your revenue recognition policy, management’s analysis of separate units of accounting under EITF 00-21 and management’s justification of the period over which you anticipate recognizing revenue. While we believe that our disclosure reflects the significant terms of the Collaboration between the Company and King, we would like some additional guidance on the information your comment is requesting of us. Our current disclosures regarding the terms of the Collaboration Agreement between the Company and King and the related License Agreement (collectively, the “Collaboration”) appear in: (i) Item 1. Business – Overview, (ii) Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations – Overview, and (iii) in Note 3 to the financial statements. The policies applied in determining the revenue recognized and included in Note 3 to the financial statements are described in more detail in Note 2- Summary of Significant Accounting Policies, Revenue Recognition and Deferred Program Fee Revenue. In accounting for the strategic alliance with King, we considered each of our deliverables and associated sources of revenue under the Collaboration. For these purposes, we noted that there are two such sources: the up-front cash license payment and the funding of development expenses for Collaboration Candidates. A summary of our revenue recognition policy, including our justification of the period over which we anticipate recognizing revenue, follows for each such revenue source. James Rosenberg, Senior Assistant Chief Accountant Securities and Exchange Commission Division of Corporation Finance. Page 5 1. Accounting for the up-front cash payment as program fee revenue King paid to us a one-time upfront fee in the amount of $150,000,000. We are obligated to perform certain development activities under the Collaboration. We recognize as program fee revenue the up-front payment on a straight line basis between the effective date of the Collaboration and the end of the duration of development activities. The up-front license fee cannot be separated from research and development services to be provided under the Collaboration pursuant to EITF 00-21. Therefore, we account for the revenue from the up-front fee over the expected duration of all the research and development activities. We estimate the duration of all the research and development activities during the Collaboration based on our current understanding of the time needed to collect the information necessary to file an NDA for each of the collaboration candidates. We disclose how we account for program fee revenue in the Form 10-K under Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and in Notes 2 and 3 to the financial statements. As our research and development activities progress, we may change our estimate of the duration of research and development activities for Collaboration Candidates. If such a change occurs, we will then amortize the remaining balance of the up-front fee over the updated remaining duration. 2. Funding of development expenses We recognize Collaboration revenue from King in the period in which the related costs are incurred and when we believe the receipt of reimbursement is reasonably assured. Our business is focused on the development of drugs, and our business strategy includes establishing strategic alliances with partners, such as our Collaboration with King where King reimburses development expenses that we incur pursuant to the terms of the Collaboration. The contract revenue that stems from reimbursement of our expenses incurred pursuant to these alliances is a normal part of our business and results from our ongoing major operations. We disclosed how we account for Collaboration revenue in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and in Notes 2 and 3 to the financial statements. James Rosenberg, Senior Assistant Chief Accountant Securities and Exchange Commission Division of Corporation Finance. Page 6 Other Matters The acknowledgement requested by the Staff is attached hereto as Appendix A. Please acknowledge receipt of this letter and the enclosed materials by stamping the enclosed duplicate of this letter and returning it to the undersigned in the envelope provided. Any questions or additional comments you may have may be directed to me at (650) 565-3854 or Michael O’Donnell of our office at (650) 354-4178. Sincerely, Wilson Sonsini Goodrich & Rosati Professional Corporation /s/ Gavin McCraley Gavin McCraley cc: Peter Roddy Michael J. O’Donnell, Esq. Martin Waters, Esq. Appendix A Statement from Pain Therapeutics, Inc. On behalf of Pain Therapeutics, Inc. (the “Company”), the undersigned acknowledges that: • the Company is responsible for the adequacy and accuracy of the disclosure in its Form 10-K; • the Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; and • The Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. By: /s/ Peter S. Roddy Name: Peter S. Roddy Title: Vice President and Chief Financial Officer
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