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SEC Comment Letters
Company Responses
Letter Text
Genprex, Inc.
Response Received
1 company response(s)
Medium - date proximity
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Genprex, Inc.
Response Received
1 company response(s)
High - file number match
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Genprex, Inc.
Response Received
1 company response(s)
High - file number match
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Genprex, Inc.
Response Received
2 company response(s)
High - file number match
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Genprex, Inc.
Response Received
1 company response(s)
High - file number match
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Genprex, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2019-09-23
Genprex, Inc.
Summary
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Company responded
2019-10-04
Genprex, Inc.
References: September 23, 2019
Summary
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Genprex, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-10-22
Genprex, Inc.
Summary
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Genprex, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2019-09-18
Genprex, Inc.
Summary
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Company responded
2019-09-30
Genprex, Inc.
References: September 17, 2019
Summary
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Company responded
2019-10-16
Genprex, Inc.
References: October 11, 2019
Summary
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Genprex, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-10-15
Genprex, Inc.
Summary
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Genprex, Inc.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2018-06-14
Genprex, Inc.
Summary
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Company responded
2018-06-15
Genprex, Inc.
References: June 13, 2018
Summary
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Company responded
2018-07-13
Genprex, Inc.
References: June 28, 2018
Summary
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Genprex, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-06-28
Genprex, Inc.
Summary
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Genprex, Inc.
Response Received
8 company response(s)
High - file number match
SEC wrote to company
2017-08-04
Genprex, Inc.
Summary
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Company responded
2017-08-18
Genprex, Inc.
References: August 3, 2017
Summary
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Company responded
2017-09-08
Genprex, Inc.
References: September 1, 2017
Summary
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Company responded
2017-09-22
Genprex, Inc.
References: September 19, 2017
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Genprex, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2017-09-19
Genprex, Inc.
Summary
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Genprex, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2017-09-01
Genprex, Inc.
Summary
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Genprex, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-06-30
Genprex, Inc.
Summary
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Company responded
2017-07-20
Genprex, Inc.
References: June 30, 2017
Summary
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-12 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2025-09-11 | SEC Comment Letter | Genprex, Inc. | TX | 377-08425 | Read Filing View |
| 2025-06-16 | SEC Comment Letter | Genprex, Inc. | TX | 333-287962 | Read Filing View |
| 2025-06-16 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2023-06-07 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2023-04-27 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2020-07-15 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2020-07-01 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2020-06-29 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2020-05-18 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2020-01-02 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2019-10-24 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2019-10-22 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2019-10-16 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2019-10-15 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2019-10-04 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2019-09-30 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2019-09-23 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2019-09-18 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2018-07-26 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2018-07-13 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2018-06-28 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2018-06-15 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2018-06-14 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-10-12 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-10-12 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-10-10 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-09-26 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-09-22 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-09-19 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-09-15 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-09-08 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-09-01 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-08-18 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-08-04 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-07-20 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-06-30 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-11 | SEC Comment Letter | Genprex, Inc. | TX | 377-08425 | Read Filing View |
| 2025-06-16 | SEC Comment Letter | Genprex, Inc. | TX | 333-287962 | Read Filing View |
| 2023-04-27 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2020-06-29 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2020-01-02 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2019-10-22 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2019-10-15 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2019-09-23 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2019-09-18 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2018-06-28 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2018-06-14 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-09-19 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-09-01 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-08-04 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-06-30 | SEC Comment Letter | Genprex, Inc. | TX | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-12 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2025-06-16 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2023-06-07 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2020-07-15 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2020-07-01 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2020-05-18 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2019-10-24 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2019-10-16 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2019-10-04 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2019-09-30 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2018-07-26 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2018-07-13 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2018-06-15 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-10-12 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-10-12 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-10-10 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-09-26 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-09-22 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-09-15 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-09-08 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-08-18 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
| 2017-07-20 | Company Response | Genprex, Inc. | TX | N/A | Read Filing View |
2025-09-12 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm gnpx20250911_corresp.htm September 12, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4720 100 F Street, N.E. Washington, D.C. 20549 Re: Genprex, Inc. Registration Statement on Form S-1 File No. 333-290227 Acceleration Request Requested Date: September 16, 2025 Requested Time: 4:05 p.m. , Eastern Time Dear Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Genprex, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission (the “Commission”) at the “Requested Date” and “Requested Time” set forth above or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Commission. Please call Kate Basmagian of Lowenstein Sandler LLP at (646) 414-6941 to confirm the effectiveness of the Registration Statement or with any questions. Sincerely, GENPREX, INC. By: /s/ Ryan M. Confer Name: Ryan M. Confer Title: President, Chief Executive Officer and Chief Financial Officer
2025-09-11 - UPLOAD - Genprex, Inc. File: 377-08425
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 11, 2025 Ryan Confer Chief Executive Officer Genprex, Inc. 3300 Bee Cave Road #650-227 Austin, TX 78746 Re: Genprex, Inc. Draft Registration Statement on Form S-1 Submitted September 5, 2025 CIK No. 0001595248 Dear Ryan Confer: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement and non-public draft submission on EDGAR at least two business days prior to the requested effective date and time. 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 Jessica Dickerson at 202-551-8013 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Kate Basmagian, Esq. </TEXT> </DOCUMENT>
2025-06-16 - UPLOAD - Genprex, Inc. File: 333-287962
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> June 16, 2025 Ryan Confer President, Chief Executive Officer and Chief Financial Officer Genprex, Inc. 3300 Bee Cave Road #650-227 Austin, TX 78746 Re: Genprex, Inc. Registration Statement on Form S-1 Filed June 11, 2025 File No. 333-287962 Dear Ryan Confer: 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 Alan Campbell at 202-551-4224 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Lloyd Jeglikowski, Esq. </TEXT> </DOCUMENT>
2025-06-16 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm gnpx20250616_corresp.htm June 16, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4720 100 F Street, N.E. Washington, D.C. 20549 Re: Genprex, Inc. Registration Statement on Form S-1 File No. 333-287962 Acceleration Request Requested Date: June 17, 2025 Requested Time: 4:05 p.m. , Eastern Time Dear Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Genprex, Inc. (the “Company”) hereby requests that the above-referenced Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission (the “Commission”) at the “Requested Date” and “Requested Time” set forth above or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Commission. Please call Kate Basmagian of Lowenstein Sandler LLP at (646) 414-6941 to confirm the effectiveness of the Registration Statement or with any questions. Sincerely, GENPREX, INC. By: /s/ Ryan M. Confer Name: Ryan M. Confer Title: President, Chief Executive Officer and Chief Financial Officer
2023-06-07 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm gnpx20230521_corresp.htm 3300 Bee Cave Road, #650-227 Austin, TX 78746 June 7, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Jason Drory Re: Genprex, Inc. Registration Statement on Form S-3 Filed on April 21, 2023 File No. 333-271386 Acceleration Request Requested Date: June 9, 2023 Requested Time: 4:30 p.m., Eastern Time Ladies and Gentlemen: In connection with the above-captioned Registration Statement (the "Registration Statement"), and pursuant to Rule 461 under the Securities Act of 1933, as amended (the "Act"), Genprex, Inc. (the "Company") hereby requests that the above-mentioned Registration Statement be declared effective by the Securities and Exchange Commission (the "Commission") at 4:30 p.m., Eastern Time, on June 9, 2023, or as soon thereafter as practicable. Please call Alan Wovsaniker of Lowenstein Sandler LLP at 973-597-2564 to confirm the effectiveness of the Registration Statement or with any questions that you may have. GENPREX, INC. By: /s/ Ryan M. Confer Name: Ryan M. Confer Title: Chief Financial Officer
2023-04-27 - UPLOAD - Genprex, Inc.
United States securities and exchange commission logo
April 27, 2023
J. Rodney Varner
Chief Executive Officer
Genprex, Inc.
3300 Bee Cave Road, #650-227
Austin, TX 78746
Re:Genprex, Inc.
Registration Statement on Form S-3
Filed April 21, 2023
File No. 333-271386
Dear J. Rodney Varner:
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 Jason Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Kate Basmagian
2020-07-15 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm gnpx20200715_corresp.htm Genprex, Inc. 1601 Trinity Street, Bldg B, Suite 3.312.09 Austin, TX 78712 July 15, 2020 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Abby Adams and Joe McCann Re: Genprex, Inc. Registration Statement on Form S-3 File No. 333-239134 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Genprex, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 5:30 p.m., Eastern Standard Time, on Friday July 17, 2020, or as soon thereafter as possible. Please notify Nazia Khan of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 653-8179 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request. GENPREX, INC. By: /s/ J. Rodney Varner Name: J. Rodney Varner Title: Chief Executive Officer
2020-07-01 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm gnpx20191003_corresp.htm GENPREX, INC. 1601 Trinity Street, Suite 3.312.09 Austin, TX 78712 July 1, 2020 VIA EDGAR United States Securities and Exchange Commission 100 F. Street, NE Washington, DC 20549 Attn: Abby Adams Joe McCann Re: Genprex, Inc. Registration Statement on Form S-3 Filed June 12, 2020 File No. 333-239134 Dear Ladies and Gentlemen: This letter sets forth responses on behalf of Genprex, Inc., a Delaware corporation (the “Company”), to the comments received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) set forth in your letter dated June 26, 2020 (“Comment Letter”) regarding the Company’s Registration Statement on Form S-3 (the “Registration Statement”). For the convenience of the Staff, each comment from the Comment Letter corresponds to the numbered paragraphs in this letter and is restated prior to the response to such comment. Registration Statement on Form S-3 Description of Capital Stock Certificate of Incorporation and Bylaws, page 17 1. We refer to Exhibit 4.12 to your Form 10-K and your October 4, 2019 correspondence to the Staff representing that you would revise your risk factor disclosure in future Annual Reports on Form 10-K, and other applicable future filings, to clarify that the Company's forum selection provision "does not apply" to actions arising under the Securities Act or the Exchange Act. We note; however, that the risk factor disclosure in your most recent Form 10-K, which is incorporated by reference into this Form S-3, does not contain a definitive statement concerning applicability but rather indicates a belief that the provision "may not apply." Accordingly, please revise your Form S-3, and future filings, as applicable, to clarify that the forum provision does not apply to such actions, or advise. RESPONSE: The Registration Statement has been revised to clarify that the forum provision does not apply to actions arising under the Securities Act or the Exchange Act. Sincerely, Genprex, Inc. /s/ J. Rodney Varner By: J. Rodney Varner Title: Chief Executive Officer
2020-06-29 - UPLOAD - Genprex, Inc.
United States securities and exchange commission logo
June 26, 2020
J. Rodney Varner
Chief Executive Officer
Genprex, Inc.
1601 Trinity Street, Bldg B, Suite 3.312.09
Austin, TX 78712
Re:Genprex, Inc.
Registration Statement on Form S-3
Filed June 12, 2020
File No. 333-239134
Dear Mr. Varner:
We have limited our review of your registration statement to those issues we have
addressed in our comment. In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.
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 the comment, we may have additional comments.
Registration Statement on Form S-3
Description of Capital Stock
Certificate of Incorporation and Bylaws, page 17
1.We refer to Exhibit 4.12 to your Form 10-K and your October 4, 2019 correspondence to
the Staff representing that you would revise your risk factor disclosure in future Annual
Reports on Form 10-K, and other applicable future filings, to clarify that the Company's
forum selection provision "does not apply" to actions arising under the Securities Act or
the Exchange Act. We note; however, that the risk factor disclosure in your most recent
Form 10-K, which is incorporated by reference into this Form S-3, does not contain a
definitive statement concerning applicability but rather indicates a belief that the provision
"may not apply." Accordingly, please revise your Form S-3, and future filings, as
applicable, to clarify that the forum provision does not apply to such actions, or advise.
FirstName LastNameJ. Rodney Varner
Comapany NameGenprex, Inc.
June 26, 2020 Page 2
FirstName LastName
J. Rodney Varner
Genprex, Inc.
June 26, 2020
Page 2
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.
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 Abby Adams at (202) 551-6902 or Joe McCann at (202) 551-6262 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2020-05-18 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm gnpx20191024_corresp.htm Genprex, Inc. 1601 Trinity Street, Bldg. B, Suite 3.322 Austin, Texas 78712 May 18, 2020 VIA EDGAR United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attention: Tim Buchmiller Re: Genprex, Inc. Registration Statement on Form S-1 File No. 333-235733 Request for Acceleration of Effectiveness Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Genprex, Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 5:00 p.m., Eastern Time, on Wednesday May 20, 2020, or as soon thereafter as possible. Please notify Nazia Khan of Sheppard Mullin Richter & Hampton LLP, counsel to the Company, at (212) 653-8179 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request. Sincerely, GENPREX, INC. By: /s/ J. Rodney Varner Name: J. Rodney Varner Title: Chief Executive Officer
2020-01-02 - UPLOAD - Genprex, Inc.
January 2, 2020
J. Rodney Varner
Chief Executive Officer
Genprex, Inc.
1601 Trinity Street, Bldg. B, Suite 3.322
Austin, Texas, 78712
Re:Genprex, Inc.
Registration Statement on Form S-1
Filed December 27, 2017
File No. 333-235733
Dear Mr. Varner:
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 Tim Buchmiller at (202) 551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Richard A. Friedman, Esq.
2019-10-24 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm gnpx20191024_corresp.htm Genprex, Inc. 1601 Trinity Street, Bldg. B, Suite 3.322 Austin, Texas 78712 October 24, 2019 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ada Sarmento Re: Genprex, Inc. Registration Statement on Form S-3 File No. 333-233774 Request for Acceleration of Effectiveness Dear Ms. Sarmento: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Genprex, Inc. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to October 28, 2019, at 5:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Streusand, Landon, Ozburn & Lemmon, LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this request, the Company acknowledges that it is aware of its responsibilities under the Act. Please direct any questions regarding this request to Christopher Ozburn (512-236-9908; ozburn@slollp.com) of Streusand, Landon, Ozburn & Lemmon, LLP. In addition, please notify Mr. Ozburn when this request for acceleration has been granted. Sincerely, GENPREX, INC. By: /s/ J. Rodney Varner J. Rodney Varner Chief Executive Officer
2019-10-22 - UPLOAD - Genprex, Inc.
October 22, 2019
Ryan M. Confer
Chief Financial Officer
Genprex, Inc.
1601 Trinity Street, Bldg B
Suite 3.322
Austin, TX 78712
Re:Genprex, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed April 1, 2019
Form 10-Q for the Quarterly Period Ended June 30, 2019
Filed August 13, 2019
File No. 001-38244
Dear Mr. Confer:
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
2019-10-16 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm gnpx20191016_corresp.htm [Genprex letterhead] October 16, 2019 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Healthcare and Insurance 100 F Street, N.E. Washington, D.C. 20549 Attention: Vanessa Robertson Lisa Vanjoske Re: Genprex, Inc. Form 10-K for the Fiscal Year Ended December 31, 2018 Filed April 1, 2019 Form 10-Q for the Quarterly Period Ended June 30, 2019 Filed August 13, 2019 File No. 001-38244 Dear Ms. Robertson and Ms. Vanjoske: This letter is being submitted in response to the comment letter dated October 11, 2019 (the “Comment Letter”) from the staff of the Securities and Exchange Commission (the “Commission”) addressed to Ryan M. Confer, Chief Financial Officer of Genprex, Inc. (the “Company”). This letter contains the Company’s responses to the Comment Letter. For your convenience, each comment is repeated below, followed by the Company’s response. Form 10-K for the Fiscal Year Ended December 31, 2018 Item 9A. Controls and Procedures, page 84 1. We have considered your response to comment one and do not agree with your conclusion regarding the effectiveness of disclosure controls and procedures as of December 31, 2018. As indicated in our original comment, we refer you to the following statement in the fourth paragraph of Sections II.D of SEC Release No. 33-8238 which states that “disclosure controls and procedures will include those components of internal control over financial reporting that provide reasonable assurances that transactions are recorded as necessary to permit preparation of the financial statements in accordance with generally accepted accounting principles.” We believe the nature of your material weakness relates to an aspect of internal control over financial reporting that is also a part of disclosure controls and procedures. Please amend your filings to conclude that disclosure controls and procedures were not effective. Securities and Exchange Commission October 16, 2019 Page 2 Response: In response to the Staff’s comment, the Company is filing today (i) Amendment No. 1 on Form 10-K/A for the fiscal year ended December 31, 2018; (ii) Amendment No. 2 on Form 10-Q/A for the quarterly period ended March 31, 2019; and (iii) Amendment No. 1 on Form 10-Q/A for the quarterly period ended June 30, 2019. Each of these amendments states that the Company’s disclosure controls and procedures were not effective as of December 31, 2018 due to the identified material weakness. Form 10-Q for the Quarterly Period Ended June 30, 2019 Item 6. Exhibits, page 52 2. We acknowledge your response to comment three. Please file the amended Form 10-Qs for the periods ended March 31, 2019 and June 30, 2019 and include the correct certifications. Response: In response to the Staff’s comment, each of the two amendments on Form 10-Q/A that the Company is filing today includes the correct certifications. * * * If you have any questions or comments regarding this response, please do not hesitate to contact the undersigned at 512-893-7397 or ryan@genprex.com. Very truly yours, /s/ RYAN M. CONFER Ryan M. Confer Chief Financial Officer cc: J. Rodney Varner, Genprex, Inc. Craig M. Podrachik, Daszkal Bolton LLP Christopher J. Ozburn, Streusand, Landon, Ozburn & Lemmon, LLP
2019-10-15 - UPLOAD - Genprex, Inc.
October 11, 2019
Ryan M. Confer
Chief Financial Officer
Genprex, Inc.
1601 Trinity Street, Bldg B
Suite 3.322
Austin, TX 78712
Re:Genprex, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed April 1, 2019
Form 10-Q for the Quarterly Period Ended June 30, 2019
Filed August 13, 2019
File No. 001-38244
Dear Mr. Confer:
We have reviewed your September 30, 2019 response to our comment letter and have the
following comments. In some of our comments, we may ask you to provide us with information
so we may better understand your disclosure.
Please respond to these comments 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
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional
comments. Unless we note otherwise, our references to prior comments are to comments in our
September 17, 2019 letter.
Form 10-K for the Fiscal Year Ended December 31, 2018
Item 9A. Controls and Procedures, page 84
1.We have considered your response to comment one and do not agree with your conclusion
regarding the effectiveness of disclosure controls and procedures as of December 31,
2018. As indicated in our original comment, we refer you to the following statement in
the fourth paragraph of Sections II.D of SEC Release No. 33-8238 which states that
"disclosure controls and procedures will include those components of internal control over
financial reporting that provide reasonable assurances that transactions are recorded as
necessary to permit preparation of the financial statements in accordance with generally
FirstName LastNameRyan M. Confer
Comapany NameGenprex, Inc.
October 11, 2019 Page 2
FirstName LastName
Ryan M. Confer
Genprex, Inc.
October 11, 2019
Page 2
accepted accounting principles". We believe the nature of your material weakness
relates to an aspect of internal control over financial reporting that is also a part of
disclosure controls and procedures. Please amend your filings to conclude that disclosure
controls and procedures were not effective.
Form 10-Q for the Quarterly Period Ended June 30, 2019
Item 6. Exhibits, page 85
2.We acknowledge your response to comment three. Please file the amended Form 10-Qs
for the periods ended March 31, 2019 and June 30, 2019 and include the correct
certifications.
You may contact Vanessa Robertson at 202-551-3649 or Lisa Vanjoske at 202-551-
3614 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2019-10-04 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm gnpx20191003_corresp.htm STREUSAND, LANDON, OZBURN & LEMMON, LLP 1801 S. MoPac Expressway Suite 320 Austin, Texas 78704 (512) 236-9908 (512) 236-9904 (fax) ozburn@slollp.com October 4, 2019 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ada D. Sarmento Joe McCann Re: Genprex, Inc. Registration Statement on Form S-3 Filed September 16, 2019 File No. 333-233774 Dear Ms. Sarmento and Mr. McCann: This letter is submitted on behalf of our client, Genprex, Inc. (the “Company” or “Genprex”), in response to the comments received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated September 23, 2019 (the “Comment Letter”) with respect to the Company’s Registration Statement on Form S-3 filed with the Commission on September 16, 2019 (the “Registration Statement”). We have revised the Registration Statement in response to the Staff’s comment and are filing via EDGAR concurrently with this letter Amendment No. 1 to the Registration Statement (“Amendment No. 1”), which reflects this revision. The numbering of the paragraphs below correspond to the numbering in the Comment Letter, the text of which we have incorporated into this response letter for convenience. Except where otherwise indicated, page references in the text of the response below corresponds to the page numbers of the Registration Statement. Staff Comments and Company Responses Registration Statement on Form S-3 Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws, page 18 United States Securities and Exchange Commission October 4, 2019 Page 2 1. We note that your forum selection provision identifies the Court of Chancery of the State of Delaware as the exclusive forum for certain litigation, including any "derivative action." Please disclose whether this provision applies to actions arising under the Securities Act or Exchange Act. In that regard, we note that Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder, and Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. If the provision applies to Securities Act claims, please also revise your prospectus to state that there is uncertainty as to whether a court would enforce such provision and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. If this provision does not apply to actions arising under the Securities Act or Exchange Act, please tell us how you will inform investors in future filings that the provision does not apply to any actions arising under the Securities Act or Exchange Act. Response: The Company acknowledges the Staff’s comment. In response to the Staff’s comment, the Company has revised its disclosure on page 19 of Amendment No. 1 to clarify the intent of the Company’s forum selection provision. The Company currently includes a risk factor in its periodic reports entitled “Certain provisions in our organizational documents could enable our board of directors to prevent or delay a change of control.” The Company advises the Staff that it will revise this risk factor in future Annual Reports on Form 10-K and other applicable future filings to clarify that the Company’s forum selection provision does not apply to actions arising under the Securities Act or the Exchange Act. General 2. As you know, the staff is currently reviewing your Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and have issued comments in connection with that review. Please note that we will not be in a position to declare this registration statement effective until you have resolved all comments on the Form 10-K. Response: The Company acknowledges the Staff’s comment. On September 30, 2019, the Company filed via EDGAR a letter in response to the Staff’s letter of September 17, 2019, which set forth the Staff’s comments on the Company’s Form 10-K for the Fiscal Year Ended December 31, 2018 and form 10-Q for the Quarterly Period Ended June 30, 2019. United States Securities and Exchange Commission October 4, 2019 Page 3 The Company looks forward to an expeditious resolution of the Staff’s comments on the Company’s Form 10-K and Form 10-Q. * * * We hope that the revisions reflected in Amendment No. 1 are acceptable to the Staff. Please contact me at (512) 236-9908 with any questions about the Registration Statement or this letter. Sincerely, STREUSAND, LANDON, OZBURN & LEMMON, LLP /s/ Christopher J. Ozburn Christopher J. Ozburn Enclosure cc: J. Rodney Varner, Genprex, Inc.
2019-09-30 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm gnpx20190927_corresp.htm [Genprex letterhead] September 30, 2019 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Healthcare and Insurance 100 F Street, N.E. Washington, D.C. 20549 Attention: Vanessa Robertson Lisa Vanjoske Re: Genprex, Inc. Form 10-K for the Fiscal Year Ended December 31, 2018 Filed April 1, 2019 Form 10-Q for the Quarterly Period Ended June 30, 2019 Filed August 13, 2019 File No. 001-38244 Dear Ms. Robertson and Ms. Vanjoske: This letter is being submitted in response to the comment letter dated September 17, 2019 (the “Comment Letter”) from the staff of the Securities and Exchange Commission (the “Commission”) addressed to Ryan M. Confer, Chief Financial Officer of Genprex, Inc. (the “Company”). This letter contains the Company’s responses to the Comment Letter. For your convenience, each comment is repeated below, followed by the Company’s response. Form 10-K for the Fiscal Year Ended December 31, 2018 Item 9A. Controls and Procedures, page 84 1. Please tell us how you determined that a conclusion that your internal control over financial reporting (ICFR) was not effective as of December 31, 2018, did not impact your conclusion regarding the effectiveness of your disclosure controls and procedures (DCP), as defined in Exchange Act Rules 13a-15(e) and 15d-15(e). Please refer to SEC Release No. 33-8238, Final Rule: Management’s Report on Internal Control Over Financial Reporting and Certification of Disclosure in Exchange Act Periodic Reports, which states that disclosure controls and procedures will include those components of internal control over financial reporting that provide reasonable assurances that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles. Please explain how you determined that the material weaknesses in your ICFR was not one of the components of ICFR that is also included in disclosure controls and procedures. This comment also applies to your DCP conclusions contained in your Forms 10-Q for the quarterly periods ended March 31 and June 30, 2019. Securities and Exchange Commission September 30, 2019 Page 2 Response: The Company acknowledges the Staff’s comment and the statements in SEC Release No. 33-8238. Rule 13a-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”) defines disclosure controls and procedures (“DCP”) to mean controls and other procedures designed to ensure that information required to be disclosed is recorded, processed, summarized and reported within the time periods specified in the Commission’s rules and forms. Rule 13a-15(f) under the Exchange Act defines internal control over financial reporting (“ICFR”) as a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. The Company’s principal executive officer and principal financial officer concluded that its DCP for its fiscal year ended December 31, 2018 remained effective, notwithstanding the existence of a material weakness identified in its ICFR, because throughout this period the Company established and maintained processes and procedures to ensure that all information was properly recorded, processed, summarized and reported. These processes and procedures included, but were not limited to: (1) a comprehensive review of the Company’s periodic reports by the Company’s Chief Financial Officer and Chief Executive Officer and by the Audit Committee of the Company’s board of directors; (2) detailed review of non-financial information, including board and executive level materials; and (3) the timely reporting of all information in the periodic reports. The Company has three senior executives, and each executive is made aware of material transactions of the Company The Company’s principal executive and principal financial officer also considered that the identified material weakness in the ICFR is isolated to issues outside of the Company’s DCP. The Company does not have sufficient personnel to separate duties of origination, authorization and review of each financial disbursement; however, all disbursements are reviewed by both the Company’s Chief Financial Officer and Chief Executive Officer. While the Company ultimately determined to report a material weakness in ICFR, the Company reached its conclusion after careful consideration of factors based on the limited availability of personnel to conduct internal review processes. However, the Company believes that the effectiveness of its DCP was not affected by this material weakness in ICFR because: (1) the Company’s Chief Financial Officer and Chief Executive Officer reviewed every transaction, as well as the Company’s financial statements and periodic reports, to be sure that all material transactions were reported; and (2) the Audit Committee of the Company’s board of directors also reviewed all financial statements and periodic reports. Securities and Exchange Commission September 30, 2019 Page 3 Financial Statements Notes to Financial Statements Note 5 - Equity, page F-10 2. You state on page F-12 "The per-share fair values of these options range from $0.001 to $7.93, based on Black-Scholes-Merton pricing models with the following assumptions," however you do not disclose the assumptions. Please provide us the assumptions required to be disclosed by ASC 718-10-50 and tell us your consideration of disclosing the assumptions. In addition, ASC-718-10-50 requires disclosure of "As of the latest balance sheet date presented, the total compensation cost related to nonvested awards not yet recognized and the weighted-average period over which it is expected to be recognized." Please direct us to or provide us this information and tell us your consideration of disclosing this information. Response: The assumptions used by the Company in making the Black-Scholes-Merton calculations of the fair value of stock-based compensation related to stock options granted during the year ended December 31, 2018 are set forth in the table below. These assumptions were inadvertently omitted from the notes to the Company’s financial statements, and will be provided in the Company’s future filings. Expected term: 10 years Risk-free rate: 2.33% – 2.60% Volatility: 76.87% Dividend yield: 0% As of December 31, 2018, the Company’s total compensation cost related to nonvested time-based stock option awards granted to employees and board members and not yet recognized was approximately $4.5 million. The Company expects to record this stock-based compensation expense over the next three years, in the amount of $3.3 million with respect to stock option awards using a graded vesting method and $1.2 million with respect to stock option awards using a cliff vesting method. The weighted average periods over which these expenses are expected to be recognized are 2.34 years and 0.69 years, respectively. As of December 31, 2018, the Company’s total compensation cost related to nonvested performance-based stock option awards granted to an employee and not yet recognized was approximately $2.6 million. One-half of this amount, or $1.3 million, may be recognized and recorded, upon the achievement of certain milestones, within 0.92 years from December 31, 2018, and the remaining $1.3 million may be recognized and recorded within 2.42 years from December 31, 2018. These disclosures were inadvertently omitted from the notes to the Company’s financial statements, and will be provided in the Company’s future filings. Securities and Exchange Commission September 30, 2019 Page 4 Form 10-Q for the Quarterly Period Ended June 30, 2019 Item 6. Exhibits, page 52 3. Please amend your filing to provide new certifications filed as Exhibits 31.1 and 31.2 to conform exactly to that provided in Item 601(b)(31) of Regulation S-K as it relates to internal controls over financial reporting (ICFR). In this regard, the introductory sentence in paragraph 4 should refer to ICFR as defined in the Exchange Act and certification 4(b) should discuss your obligations related to ICFR. Similarly, please amend the 10-Q for the quarterly period ended March 31, 2019. Response: The Company’s Chief Executive Officer and Chief Financial Officer each executed a certification that conformed exactly to the requirements of Item 601 of Regulation S-K. The certifications filed as Exhibits 31.1 and 31.2 to each of the Company’s 10-Q for the quarterly periods ended March 31, 2019 and June 30, 2019, respectively, did not conform exactly to the requirements of Item 601 of Regulation S-K due to an inadvertent transcription error. In accordance with the Staff’s request, the Company will amend its filings of the 10-Q for the quarterly period ended March 31, 2019 and the 10-Q for the quarterly period ended June 30, 2019 to file the correct certifications as Exhibits 31.1 and 31.2. The Company acknowledges the Staff’s closing comments in your letter dated September 17, 2019. * * * If you have any questions or comments regarding this response, please do not hesitate to contact the undersigned at 512-893-7397 or ryan@genprex.com. Very truly yours, /s/ RYAN M. CONFER Ryan M. Confer Chief Financial Officer cc: J. Rodney Varner, Genprex, Inc. Craig M. Podrachik, Daszkal Bolton LLP Christopher J. Ozburn, Streusand, Landon, Ozburn & Lemmon, LLP
2019-09-23 - UPLOAD - Genprex, Inc.
September 23, 2019
J. Rodney Varner
Chief Executive Officer
Genprex, Inc.
1601 Trinity Street, Bldg. B, Suite 3.322
Austin, Texas 78712
Re:Genprex, Inc.
Registration Statement on Form S-3
Filed September 16, 2019
File No. 333-233774
Dear Mr. Varner:
We have limited our review of your registration statement to those issues we have
addressed in our comments. In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply 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 these comments, we may have additional comments.
Registration Statement on Form S-3
Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws, page 18
1.We note that your forum selection provision identifies the Court of Chancery of the State
of Delaware as the exclusive forum for certain litigation, including any “derivative
action.” Please disclose whether this provision applies to actions arising under the
Securities Act or Exchange Act. In that regard, we note that Section 27 of the Exchange
Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or
liability created by the Exchange Act or the rules and regulations thereunder, and Section
22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all
suits brought to enforce any duty or liability created by the Securities Act or the rules and
regulations thereunder. If the provision applies to Securities Act claims, please also revise
your prospectus to state that there is uncertainty as to whether a court would enforce such
FirstName LastNameJ. Rodney Varner
Comapany NameGenprex, Inc.
September 23, 2019 Page 2
FirstName LastName
J. Rodney Varner
Genprex, Inc.
September 23, 2019
Page 2
provision and that investors cannot waive compliance with the federal securities laws and
the rules and regulations thereunder. If this provision does not apply to actions arising
under the Securities Act or Exchange Act, please tell us how you will inform investors in
future filings that the provision does not apply to any actions arising under the Securities
Act or Exchange Act.
General
2.As you know, the staff is currently reviewing your Annual Report on Form 10-K for the
fiscal year ended December 31, 2018 and have issued comments in connection with that
review. Please note that we will not be in a position to declare this registration statement
effective until you have resolved all comments on the Form 10-K.
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.
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 Ada D. Sarmento at 202-551-3798 or Joe McCann at 202-551-6262 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Christopher J. Ozburn, Esq.
2019-09-18 - UPLOAD - Genprex, Inc.
September 17, 2019
Ryan M. Confer
Chief Financial Officer
Genprex, Inc.
1601 Trinity Street, Bldg B
Suite 3.322
Austin, TX 78712
Re:Genprex, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed April 1, 2019
Form 10-Q for the Quarterly Period Ended June 30, 2019
Filed August 13, 2019
File No. 001-38244
Dear Mr. Confer:
We have reviewed your filings and have the following comments. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to these comments 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
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2018
Item 9A. Controls and Procedures, page 84
1.Please tell us how you determined that a conclusion that your internal control over
financial reporting (ICFR) was not effective as of December 31, 2018, did not impact your
conclusion regarding the effectiveness of your disclosure controls and procedures (DCP),
as defined in Exchange Act Rules 13a-15(e) and 15d-15(e). Please refer to SEC Release
No. 33-8238, Final Rule: Management’s Report on Internal Control Over Financial
Reporting and Certification of Disclosure in Exchange Act Periodic Reports, which states
that disclosure controls and procedures will include those components of internal control
over financial reporting that provide reasonable assurances that transactions are recorded
as necessary to permit preparation of financial statements in accordance with generally
FirstName LastNameRyan M. Confer
Comapany NameGenprex, Inc.
September 17, 2019 Page 2
FirstName LastName
Ryan M. Confer
Genprex, Inc.
September 17, 2019
Page 2
accepted accounting principles. Please explain how you determined that the material
weaknesses in your ICFR was not one of the components of ICFR that is also included in
disclosure controls and procedures. This comment also applies to your DCP conclusions
contained in your Forms 10-Q for the quarterly periods ended March 31 and June 30,
2019.
Financial Statements
Notes to Financial Statements
Note 5 - Equity, page F-10
2.You state on page F-12 "The per-share fair values of these options range from $0.001 to
$7.93, based on Black-Scholes-Merton pricing models with the following
assumptions," however you do not disclose the assumptions. Please provide us the
assumptions required to be disclosed by ASC 718-10-50 and tell us your consideration of
disclosing the assumptions. In addition, ASC-718-10-50 requires disclosure of "As of the
latest balance sheet date presented, the total compensation cost related to nonvested
awards not yet recognized and the weighted-average period over which it is expected to be
recognized." Please direct us to or provide us this information and tell us your
consideration of disclosing this information.
Form 10-Q for the Quarterly Period Ended June 30, 2019
Item 6. Exhibits, page 52
3.Please amend your filing to provide new certifications filed as Exhibits 31.1 and 31.2
to conform exactly to that provided in Item 601(b)(31) of Regulation S-K as it relates to
internal controls over financial reporting (ICFR). In this regard, the introductory sentence
in paragraph 4 should refer to ICFR as defined in the Exchange Act and certification 4(b)
should discuss your obligations related to ICFR. Similarly, please amend the 10-Q for the
quarterly period ended March 31, 2019.
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 Vanessa Robertson at 202-551-3649 or Lisa Vanjoske at 202-551-
3614 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2018-07-26 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm Acceleration Request Genprex, Inc. 1701 Trinity Street, Suite 3.322 Austin, Texas 78705 July 26, 2018 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4546 100 F Street, N.E. Washington, D.C. 20549 Attn: Ada Sarmento Re: Genprex, Inc. Registration Statement on Form S-1 File No. 333-225090 Request for Acceleration of Effectiveness Dear Ms. Sarmento: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Genprex, Inc. (the “Company”) hereby requests acceleration of the effective date of its Registration Statement on Form S-1 (File No. 333-225090), as amended (the “Registration Statement”) to become effective on July 26, 2018, at 5:00 p.m., Eastern Time, or as soon as possible thereafter. The Registrant hereby authorizes Christopher Ozburn of Streusand, Landon, Ozburn & Lemmon, LLP, counsel to the Company, to orally modify or withdraw this request for acceleration. Please notify Christopher Ozburn at (512) 236-9908 as soon as possible as to the time the Registration Statement has been declared effective pursuant to this acceleration request Sincerely, GENPREX, INC. By: /s/ J. Rodney Varner J. Rodney Varner Chief Executive Officer cc: Christopher Ozburn, Streusand, Landon, Ozburn & Lemmon, LLP
2018-07-13 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm CORRESP STREUSAND, LANDON, OZBURN & LEMMON, LLP 811 Barton Springs Road Suite 811 Austin, Texas 78704 (512) 236-9908 (512) 236-9904 (fax) ozburn@slollp.com July 13, 2018 United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4546 100 F Street, N.E. Washington, D.C. 20549 Attn: Ada D. Sarmento Re: Genprex, Inc. Registration Statement on Form S-1 Filed May 22, 2018 File No. 333-225090 Dear Ms. Sarmento: This letter is submitted on behalf of our client, Genprex, Inc. (the “Company” or “Genprex”), in response to the comment received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated June 28, 2018 (the “Comment Letter”) with respect to the Company’s Registration Statement on Form S-1 filed with the Commission on May 22, 2018 (the “Registration Statement”). The numbering of the paragraph below corresponds to the numbering in the Comment Letter, the text of which we have incorporated into this response letter for convenience. Except where otherwise indicated, page references in the text of the response below corresponds to the page numbers of the Registration Statement. Staff Comment and Company Response The Offering, page 8 1. We note your response to our prior comment 1 and reissue. In order for the private placement of the shares to be complete and the selling stockholders to be at market risk, (i) the per share purchase price must be fixed and cannot be subject to adjustment based on the current market price of the common stock and (ii) the selling stockholders must be irrevocably bound to purchase a set number of securities at the time of the filing of the resale registration statement. The fact that the total investment amount is fixed does not therefore fit within the requirements of the accommodation set forth in CDI 139.11 of Securities Act Sections, which requires that the number of securities to be received be set. Further, the investors are not at market risk if the amount of their investment is preserved by receiving additional securities based on the market price on certain future dates. Please withdraw this registration statement and refile once the private placement has been completed. United States Securities and Exchange Commission July 13, 2018 Page 2 Response: Having carefully reviewed the Staff’s comment letters and the applicable Commission rules and Compliance and Disclosure Interpretations (“C&DIs”) referenced therein, we respectfully submit that we do not believe that the requirements articulated in C&DI 134.01 and 139.11 are applicable to the Genprex transaction, for the reasons described below. 1. C&DI 134.01 and 139.11 Do Not Apply to the Genprex Transaction The requirement articulated in C&DI 134.01 and 139.11 and Securities Act Rule 152 is that the private placement must be completed before the resale registration statement is filed. However, by their terms, C&DI 139.11 and 134.01 apply only to PIPE transactions where the securities to be offered pursuant to the registration statement (or securities convertible into such securities) have not yet been sold or issued to the selling stockholders at the time the registration statement is filed. In contrast, in the Genprex transaction, all of the shares and warrants were sold to the selling stockholders prior to the filing of the resale registration statement. Therefore, C&DI 139.11 and 134.01 do not apply to the Gentrex transaction. C&DI 134.01 and 139.11 address the specific problem caused by a PIPE transaction in which the closing of the private placement does not take place until after the filing of the resale registration statement and is contingent upon the effectiveness of the registration statement. Recognizing that in such a transaction the actual closing takes place after, rather than before, the filing and effectiveness of the resale registration statement, in C&DI 134.01 and 139.11, the Staff has formulated a set of requirements that allow parties to deem such a transaction to have been completed for purposes of Rule 152 at the time the registration statement is filed and before the transaction has actually closed. In the close-after-effectiveness structure addressed by C&DI 134.01 and 139.11, although a purchase agreement to buy and sell securities is signed before the resale registration statement is filed, no securities have been sold or issued pursuant to the purchase agreement at the time the registration statement is filed. The investors’ obligation to close the transaction is contingent upon the effectiness of the registration statement. If the registration statement is not declared effective, the closing condition is not satisfied and the investors can decline to close and walk away, with the result that no securities may ever be sold or issued pursuant to the purchase agreement. In light of this contingency, for a private placement to be deemed “constructively” completed prior to the sale or issuance of securities, C&DI 134.01 and 139.11 require that the investor must be at market risk at the time the resale registration statement is filed. In the context of a transaction where the actual sale or issuance of securities has not yet occurred at the time the resale registration is filed, this requirement means that the investor must be irrevocably bound to purchase the securities, subject only to the effectiveness of the registration statement or other conditions outside the investor’s control, and that the number of securities and the purchase price must be set in the purchase agreement and may not be contingent on the market price at the time of effectiveness of the registration statement or thereafter. United States Securities and Exchange Commission July 13, 2018 Page 3 In contrast to the transactions contemplated by C&DI 134.01 and 139.11, the Genprex private placement was actually, rather than constructively, completed before the filing of the resale registration statement. Under the purchase agreement, the investors’ obligation to close was not contingent on the effectiveness of the resale registration statement. Rather, the closing of the transaction took place on May 9, 2018, while the resale registration statement was filed with the Commission on May 22, 2018. At the closing, a specific number of securities were sold and purchased at a specific price set forth in the purchase agreement, the purchase price was paid in full, and the shares and warrants were issued to the investors. The additional securities that may be issued to the investors after the closing as a result of the adjustments set forth in the purchase agreement would not constitute additional sales of securities taking place after the effectiveness of the registration statement. Much like securities issued as a result of conversion rate adjustments applicable to convertible securities, any such additional securities would be issued to the investors for no additional consideration and would not require any additional investment decisions by the investors. The key difference between the Genprex transaction and the transactions contemplated by C&DI 134.01 and 139.11 is that the Genprex transaction actually closed before the registration statement was filed. If the Genprex registration statement is not declared effective, the investors cannot choose to terminate the purchase agreement and walk away. Nor are the investors entitled to receive a refund of any portion of the purchase price paid by them at the closing. Thus, from and after the closing, the investors are exposed to economic and other risks associated with the Company’s business, including the risk of insolvency or bankruptcy, to the same extent as any other stockholders of the Company. Moreover, the adjustments set forth in the Genprex purchase agreement will not protect the investors in the event the market price of the Company’s common stock declines below $4.25 per share following the closing. In other words, although the investors’ exposure to a potential market price decline is mitigated by the adjustments, it is not completely eliminated. As a result, the investors were at substantial market risk in respect of their investment as of the closing of the transaction on May 9, 2018. Accordingly, the Genprex private placement was completed prior to the filing of the resale registration statement on May 22, 2018. 2. C&DI 139.10 Applies to the Genprex Transaction We believe that C&DI 139.10 applies to the Genprex transaction. Unlike C&DI 134.01 and 139.11, C&DI 139.10 contemplates a transation where all of the securities convertible into the common stock to be sold to the public in the secondary offering are sold to the selling stockholders in a private placement before the filing of the resale registration statement. C&DI 139.10 states that, in such a transaction, the company may file, prior to the conversion, a registration statement for the resale of the common stock issuable upon conversion of the outstanding convertible securities, even if the securities are convertible into common stock using a conversion ratio based on the company’s common stock trading price at the time of conversion. United States Securities and Exchange Commission July 13, 2018 Page 4 While C&DI 139.10 does not expressly state that, presumably, the foregoing guidance is based on the Staff’s conclusion that the private placement described in C&DI 139.10 is completed at the time the registration statement is filed, despite the potential subsequent adjustments to the number of shares that may be issued on conversion based on the common stock trading price at the time of conversion. In other words, the possibility of a post-filing adjustment to the number of shares issuable upon conversion does not mean that the private placement is not completed before the filing. The Genprex purchase agreement contemplates that additional shares may be issued to the investors after the closing based on the market price of the Company’s common stock after the date the resale registration statement becomes effective. Similar to adjustments to the conversion ratio of convertible securities based on the company’s common stock trading price at the time of conversion, as contemplated by C&DI 139.10, any additional securities that may be issued to the investors under the Genprex purchase agreement would be issued to them for no additional consideration and would not require additional investment decisions by the investors, as noted above. Thus, we believe that the Genprex transaction is similar to the transaction contemplated by C&DI 139.10, and therefore, the Genprex private placement was completed at the time the resale registration statement was filed. 3. Resale Registration Statement Was Recently Declared Effective in a PIPE Transaction with a Similar Structure We are aware of at least one resale registration statement that was recently declared effective by the Commission in connection with a PIPE transaction with a structure virtually indentical to the Genprex transaction. On March 22, 2018, Arcadia Biosciences, Inc. issued shares of its common stock and warrants to purchase shares of its common stock to certain investors in a private placement pursuant to a securities purchase agreement dated as of March 19, 2018. Pursuant to the purchase agreement, the number of shares of common stock issued to the investors and the exercise price of the warrants were subject to adjustment based on the market price of Arcadia’s common stock after a resale registration statement was declared effective by the Commission. Arcadia filed a resale registration statement on March 30, 2018, and it was declared effective by the Commission on April 23, 2018. In structuring the Genprex transaction and preparing the resale registration statement, the parties to the Genprex transaction were aware of the Arcadia transaction and were guided by the terms and conditions thereof. In particular, the purchase price adjustment provisions contained in the Genprex purchase agreement are virtually identical to those in the Arcadia transaction. For the reasons set forth above, we respectfully request that the Staff reconsider its position with respect to Comment No. 1. * * * United States Securities and Exchange Commission July 13, 2018 Page 5 The Company respectfully requests the Staff’s assistance in completing the review of Registration Statement as soon as possible. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding the Amendment or this response letter to me at (512) 236-9908. Sincerely, STREUSAND, LANDON, OZBURN & LEMMON, LLP /s/ Christopher J. Ozburn Christopher J. Ozburn cc: Mary Beth Breslin, Securities and Exchange Commission J. Rodney Varner, Genprex, Inc.
2018-06-28 - UPLOAD - Genprex, Inc.
June 28, 2018
J. Rodney Varner
Chief Executive Officer
Genprex, Inc.
1701 Trinity Street, Suite 3.322
Austin, TX 78705
Re:Genprex, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed June 15, 2018
File No. 333-225090
Dear Mr. Varner:
We have reviewed your amended registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply 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 these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our June 13, 2018 letter.
Amendment No. 1 to Registration Statement on Form S-1
The Offering, page 8
1.We note your response to our prior comment 1 and reissue. In order for the private
placement of the shares to be complete and the selling stockholders to be at market risk,
(i) the per share purchase price must be fixed and cannot be subject to adjustment based
on the current market price of the common stock and (ii) the selling stockholders must be
irrevocably bound to purchase a set number of securities at the time of the filing of the
resale registration statement. The fact that the total investment amount is fixed does not
therefore fit within the requirements of the accommodation set forth in CDI 139.11 of
FirstName LastNameJ. Rodney Varner
Comapany NameGenprex, Inc.
June 28, 2018 Page 2
FirstName LastName
J. Rodney Varner
Genprex, Inc.
June 28, 2018
Page 2
Securities Act Sections, which requires that the number of securities to be received be set.
Further, the investors are not at market risk if the amount of their investment is preserved
by receiving additional securities based on the market price on certain future dates. Please
withdraw this registration statement and refile once the private placement has been
completed.
Please contact Ada D. Sarmento at 202-551-3798 or Mary Beth Breslin at 202-551-3625
with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Christopher Ozburn, Esq.
2018-06-15 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm CORRESP 811 Barton Springs Road Suite 811 Austin, Texas 78704 (512) 236-9908 (512) 236-9904 (fax) ozburn@slollp.com June 15, 2018 United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4546 100 F Street, N.E. Washington, D.C. 20549 Attn: Ada D. Sarmento Re: Genprex, Inc. Registration Statement on Form S-1 Filed May 22, 2018 File No. 333-225090 Dear Ms. Sarmento: This letter is submitted on behalf of our client, Genprex, Inc. (the “Company”), in response to comments received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated June 13, 2018 (the “Comment Letter”) with respect to the Company’s Registration Statement on Form S-1 filed with the Commission on May 22, 2018 (the “Registration Statement”). We have revised the Registration Statement in response to the Staff’s comment and are filing concurrently with this letter Amendment No. 1 to the Registration Statement (“Amendment No. 1”), which reflects this revision. The numbering of the paragraphs below corresponds to the numbering in the Comment Letter, the text of which we have incorporated into this response letter for convenience. Except where otherwise indicated, page references in the text of the responses below correspond to the page numbers of the Registration Statement. Staff Comments and Company Responses The Offering, page 8 1. Please note that the selling stockholders must be irrevocably bound to purchase a set number of securities for a set purchase price at the time of filing the resale registration statement subject only to the effectiveness of the registration statement or other conditions outside their control. In addition, the selling stockholders must be at market risk at the time that the resale registration statement is filed. The purchase United States Securities and Exchange Commission June 15, 2018 Page 2 price cannot be contingent on the market price at the time of effectiveness of the resale registration statement or at any subsequent date. In this regard, we note: • The per share purchase price of the shares and the per share exercise price of the warrants will automatically be adjusted based on the market price after the date that (i) a registration statement covering the resale of the securities issued in the private placement is declared effective by the SEC and (ii) your stockholders approve the private placement. • Following any adjustment of the per share purchase price of the shares, you will issue additional shares in proportion to such adjustment, and following any adjustment to the per share warrant exercise price, the number of warrant shares that may be issued pursuant to each warrant will be proportionately increased. • Another adjustment to the per share purchase price of the shares and the per share exercise price of the warrants will occur on the date that shares may be sold pursuant to Rule 144 if all of the shares issuable pursuant to the purchase agreement are not included in this resale registration statement. For these reasons, it appears that the private placement of the shares and warrants was not complete at the time this resale registration statement was filed. Please withdraw and refile once the private placement has been completed. For guidance, please refer to Securities Act Sections Compliance and Disclosure Interpretations Question 134.01. Response: We respectfully submit that the requirements of CD&I Question 134.01 were met at the time of the closing of the offering because all consideration was paid, and the investors’ final investment decision was made, on May 9, 2018. The subsequent adjustment to the number of shares does not require any new consideration to be paid, or investment decision on the part of the investors. The investment amount for the securities is fixed and was fully paid at the time of the closing on May 9, 2018 and not subject to change or adjustment at a later date. Accordingly, the investors’ full subscription amount was at market risk at the time of the filing of the registration statement. The issuance of the additional shares, if any, is akin to dilution protection and is addressed under CD&I Question 132.06 which provides that, for purposes of Rule 144, shares acquired pursuant to anti-dilution rights tack back to the original placement of the securities. The justification for the CD&I is that, at the time of the dilution adjustment, the holder is not paying any additional consideration or making any new investment decision. Similarly, in this transaction, the issuance of the shares does not require the payment of any additional consideration or new investment decision and accordingly the investor is fully at market risk at the time of the closing, which was prior to the filing of the registration statement. United States Securities and Exchange Commission June 15, 2018 Page 3 Moreover, C&DI question 134.01 addresses the circumstances in which the resale registration statement is filed, or even declared effective, before securities have been sold to the investors. In contrast, the Registration Statement was filed after the May 9, 2018 closing of the private placement. For the reasons set forth above, we respectfully request that the Staff reconsider its position with respect to Comment No. 1. Incorporation of Information by Reference, page 118 2. To the extent you file a new registration statement where you elect to use incorporation by reference, please incorporate your Form 8-K filed on March 15, 2018. Refer to Item 12(a)(2) of Form S-1. Response: The Company has added disclosure on page 115 of Amendment No. 1 to include the reference to the Company’s Current Report on Form 8-K filed on March 15, 2018. The Company respectfully requests the Staff’s assistance in completing the review of Registration Statement as soon as possible. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding the Amendment or this response letter to me at (512) 236-9908. Sincerely, STREUSAND, LANDON, OZBURN & LEMMON, LLP /s/ Christopher J. Ozburn Christopher J. Ozburn cc: Mary Beth Breslin, Securities and Exchange Commission J. Rodney Varner, Genprex, Inc.
2018-06-14 - UPLOAD - Genprex, Inc.
June 13, 2018
J. Rodney Varner
Chief Executive Officer
Genprex, Inc.
1701 Trinity Street, Suite 3.322
Austin, TX 78705
Re:Genprex, Inc.
Registration Statement on Form S-1
Filed May 22, 2018
File No. 333-225090
Dear Mr. Varner:
We have limited our review of your registration statement to those issues we have
addressed in our comments. In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply 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 these comments, we may have additional comments.
Registration Statement on Form S-1
The Offering, page 8
1.Please note that the selling stockholders must be irrevocably bound to purchase a set
number of securities for a set purchase price at the time of filing the resale registration
statement subject only to the effectiveness of the registration statement or other conditions
outside their control. In addition, the selling stockholders must be at market risk at the
time that the resale registration statement is filed. The purchase price cannot be contingent
on the market price at the time of effectiveness of the resale registration statement or at
any subsequent date. In this regard, we note:
FirstName LastNameJ. Rodney Varner
Comapany NameGenprex, Inc.
June 13, 2018 Page 2
FirstName LastName
J. Rodney Varner
Genprex, Inc.
June 13, 2018
Page 2
•The per share purchase price of the shares and the per share exercise price of the
warrants will automatically be adjusted based on the market price after the date that (i)
a registration statement covering the resale of the securities issued in the private
placement is declared effective by the SEC and (ii) your stockholders approve the
private placement.
•Following any adjustment of the per share purchase price of the shares, you will issue
additional shares in proportion to such adjustment, and following any adjustment to
the per share warrant exercise price, the number of warrant shares that may be issued
pursuant to each warrant will be proportionately increased.
•Another adjustment to the per share purchase price of the shares and the per share
exercise price of the warrants will occur on the date that shares may be sold pursuant
to Rule 144 if all of the shares issuable pursuant to the purchase agreement are not
included in this resale registration statement.
For these reasons, it appears that the private placement of the shares and warrants was not
complete at the time this resale registration statement was filed. Please withdraw and re-
file once the private placement has been completed. For guidance, please refer to
Securities Act Sections Compliance and Disclosure Interpretations Question 134.01.
Incorporation of Information by Reference, page 118
2.To the extent you file a new registration statement where you elect to use incorporation by
reference, please incorporate your Form 8-K filed on March 15, 2018. Refer to Item
12(a)(2) of Form S-1.
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.
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 Ada D. Sarmento at 202-551-3798 or Mary Beth Breslin at 202-551-3625
with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Christopher Ozburn, Esq.
2017-10-12 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm Acceleration Request October 12, 2017 VIA EDGAR TRANSMISSION Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Attn: Ms. Suzanne Hayes Re: Genprex, Inc. Registration Statement on Form S-1 (File No. 333-219386) Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, (the “Securities Act”) we, as the underwriter, hereby join in the request of Genprex, Inc., a Delaware corporation (the “Company”) for acceleration of the effective date of the above-named Registration Statement so that it becomes effective at 4:30PM (Eastern Time) on Friday, October 13, 2017, or as soon thereafter as practicable. Pursuant to Rule 418(a)(7) and Rule 460 under the Securities Act, we wish to advise you that we have effected the following distribution of the Company’s Preliminary Prospectus dated, October 10, 2017: ∎ Dates of Distribution: October 10, 2017 through date hereof ∎ Number of prospectuses furnished to institutional investors: approximately 25 ∎ Number of prospectuses furnished to individuals: approximately 100 ∎ Number of prospectuses distributed to others, including the Company, the Company’s counsel, independent accountants, and underwriters’ counsel: approximately 25 We will take reasonable steps to make the information contained in the Registration Statement conveniently available to any dealers who will participate in the distribution of the securities registered thereunder. We, the undersigned, as the underwriter, have complied with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. If you have any questions or comments regarding this request, please call, Philip Magri, Esq. of Magri Law, LLC at 954-303-8027. Very truly yours, NETWORK 1 FINANCIAL SECURITIES, INC. /s/ Damon D. Testaverde Damon D. Testaverde Director of Investment Banking The Galleria, 2 Bridge Ave., Suite 241 Red Bank, NJ 07701-116 Phone: 732-758-9001; Toll Free: 800-886-7007; Fax: 732-758-6671 Member FINRA/SIPC
2017-10-12 - CORRESP - Genprex, Inc.
CORRESP
1
filename1.htm
Acceleration Request
Genprex, Inc.
100 Congress Avenue, Suite 2000
Austin, Texas 78701
October 12, 2017
VIA EDGAR
United States Securities and Exchange
Commission
Division of Corporation Finance
Mail Stop 4546
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Suzanne Hayes
Dorman Yale
Re:
Genprex, Inc.
Registration Statement on Form S-1
File No. 333-219386
Request for Acceleration of Effectiveness
Requested Date: Friday, October 13, 2017
Requested Time: 4:30 p.m., Eastern Time
Ladies and Gentlemen:
In accordance with Rule 461 under the
Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests acceleration of the effective date of its Registration Statement on Form S-1 (File No. 333-219386), as amended
(the “Registration Statement”) to become effective on October 13, 2017, at 4:30 p.m., Eastern Time, or as soon as practicable thereafter.
By separate letter, the underwriter of the issuance of the securities being registered joins this request for acceleration.
The Registrant hereby authorizes Christopher Ozburn of Streusand, Landon & Ozburn LLP, to orally modify or withdraw this request for acceleration.
In connection with this request, the Registrant acknowledges that:
(i)
should the Commission or the Staff, acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration
Statement;
Page
2
(ii)
the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Registrant from its full responsibility for the adequacy and
accuracy of the disclosure in the Registration Statement; and
(iii)
the Registrant may not assert comments of the Commission or the staff and the declaration of effectiveness of the Registration Statement as a defense in any proceeding initiated by the Commission or any person under the
federal securities laws of the United States.
We request that we be notified of such effectiveness by a telephone call to Christopher
Ozburn at (512) 236-9908. We also request that a copy of the written order from the Commission verifying the effective date and time of the Registration Statement be sent to Streusand, Landon & Ozburn LLP, attention: Christopher
Ozburn, via facsimile at 512-236-9904.
Sincerely,
GENPREX, INC.
By:
/s/ J. Rodney Varner
J. Rodney Varner
Chief Executive Officer
cc:
Christopher Ozburn, Streusand, Landon & Ozburn LLP
2017-10-10 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm Correspondence 811 Barton Springs Road Suite 811 Austin, Texas 78704 (512) 236-9908 (512) 236-9904 (fax) ozburn@slollp.com October 10, 2017 United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4546 100 F Street, N.E. Washington, D.C. 20549 Attn: Suzanne Hayes Re: Genprex, Inc. Amendment No. 5 to Registration Statement on Form S-1 Filed September 26, 2017 File No. 333-219386 Dear Ms. Hayes: Enclosed on behalf of our client, Genprex, Inc. (the “Company”), is Amendment No. 6 to Registration Statement on Form S-1 (“Amendment No. 6”). Amendment No. 6 updates the Company’s Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission (the “Commission”) on July 21, 2017 (the “Registration Statement”), as amended by Amendment No. 1 filed with the Commission on August 18, 2017, Amendment No. 2 filed with the Commission on September 8, 2017, Amendment No. 3 filed with the Commission on September 15, 2017, Amendment No. 4 filed with the Commission on September 22, 2017 and Amendment No. 5 filed with the Commission on September 26, 2017 (“Amendment No. 5”). The copy of Amendment No. 6 that is enclosed with the paper copy of this letter is marked to show changes from Amendment No. 5. The Company respectfully requests the Staff’s assistance in completing the review of Amendment No. 6 as soon as possible. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding the Amendment or this response letter to me at (512) 236-9908. Sincerely, STREUSAND, LANDON & OZBURN, LLP /s/ Christopher J. Ozburn Christopher J. Ozburn cc: J. Rodney Varner, Genprex, Inc. Philip Magri, Magri Law LLC
2017-09-26 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm Correspondence 811 Barton Springs Road Suite 811 Austin, Texas 78704 (512) 236-9908 (512) 236-9904 (fax) ozburn@slollp.com September 26, 2017 United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4546 100 F Street, N.E. Washington, D.C. 20549 Attn: Suzanne Hayes Re: Genprex, Inc. Amendment No. 4 to Registration Statement on Form S-1 Filed September 22, 2017 File No. 333-219386 Dear Ms. Hayes: Enclosed on behalf of our client, Genprex, Inc. (the “Company”), is Amendment No. 5 to Registration Statement on Form S-1 (“Amendment No. 5”). Amendment No. 5 updates the Company’s Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission (the “Commission”) on July 21, 2017 (the “Registration Statement”), as amended by Amendment No. 1 filed with the Commission on August 18, 2017, Amendment No. 2 filed with the Commission on September 8, 2017, Amendment No. 3 filed with the Commission on September 15, 2017 and Amendment No. 4 filed with the Commission on September 22, 2017 (“Amendment No. 4”). The copy of Amendment No. 5 that is enclosed with the paper copy of this letter is marked to show changes from Amendment No. 4. The Company respectfully requests the Staff’s assistance in completing the review of Amendment No. 5 as soon as possible. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding the Amendment or this response letter to me at (512) 236-9908. Sincerely, STREUSAND, LANDON & OZBURN, LLP /s/ Christopher J. Ozburn Christopher J. Ozburn cc: J. Rodney Varner, Genprex, Inc. Philip Magri, Magri Law LLC
2017-09-22 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm Correspondence 811 Barton Springs Road Suite 811 Austin, Texas 78704 (512) 236-9908 (512) 236-9904 (fax) ozburn@slollp.com September 22, 2017 United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4546 100 F Street, N.E. Washington, D.C. 20549 Attn: Suzanne Hayes Re: Genprex, Inc. Amendments No. 2 and No. 3 to Registration Statement on Form S-1 Filed September 8, 2017 and September 15, 2017 File No. 333-219386 Dear Ms. Hayes: Enclosed on behalf of our client, Genprex, Inc. (the “Company”), is Amendment No. 4 to Registration Statement on Form S-1 (“Amendment No. 4”). Amendment No. 4 updates the Company’s Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission (the “Commission”) on July 21, 2017 (the “Registration Statement”), as amended by Amendment No. 1 filed with the Commission on August 18, 2017, by Amendment No. 2 filed with the Commission on September 8, 2017 and Amendment No. 3 filed with the Commission on September 15, 2017 (“Amendment No. 3”). The copy of Amendment No. 4 that is enclosed with the paper copy of this letter is marked to show changes from Amendment No. 3. Amendment No. 4 is being submitted in response to a comment received from the staff of the Commission (the “Staff”) by letter dated September 19, 2017 with respect to the Registration Statement (the “Comment Letter”) as well as to update the disclosure generally. The numbering of the paragraph below corresponds to the numbering in the Comment Letter, the text of which we have incorporated into this response letter for convenience. Except where otherwise indicated, page references in the text of the responses below correspond to the page numbers of the Registration Statement. United States Securities and Exchange Commission September 22, 2017 Page 2 Staff Comments and Company Responses General 1. We note the revised disclosure on your cover page that you are offering a minimum of 2,083,334 shares and a maximum of 5,625,000 shares. These amounts conflict with your disclosure throughout that you are offering a minimum of 2,500,000 shares and a maximum of 4,500,000 shares. We also note your statements that you do not intend to close this offering unless you raise minimum gross proceeds of $12,500,000, and that the disclosure in your fee table and Escrow Deposition Agreement contemplate a maximum offering amount of $22,500,000. It appears that you are registering a minimum and maximum aggregate offering amount, rather than a minimum and maximum number of shares, which is not appropriate. Please revise your disclosure throughout the registration statement and your Subscription Agreement and Escrow Deposit Agreement, as necessary, to reflect a set minimum and maximum number of shares to be offered. Refer to Item 501(b)(2) of Regulation S-K and the definition of “amount” in Securities Act Rule 405 for guidance. Response: In response to the Commission’s comment, the Company has revised the front and back cover pages of the preliminary prospectus included contained in Amendment No. 4, as well as pages 9, 47, 50, 54, 56 and 58 to reflect the change of the estimated initial public offering price from a range to a fixed price and to reflect the corresponding change of the minimum and maximum number of shares to be offered. The Company has made corresponding revisions to Exhibit 5.1 (Opinion of Streusand, Landon & Ozburn LLP), Exhibit 10.11 (Form of Amended and Restated Escrow Deposit Agreement) and Exhibit 10.19 (Form of Subscription Agreement). The Company respectfully requests the Staff’s assistance in completing the review of Amendment No. 4 as soon as possible. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding the Amendment or this response letter to me at (512) 236-9908. Sincerely, STREUSAND, LANDON & OZBURN, LLP /s/ Christopher J. Ozburn Christopher J. Ozburn cc: J. Rodney Varner, Genprex, Inc. Philip Magri, Magri Law LLC
2017-09-19 - UPLOAD - Genprex, Inc.
Mail Stop 4546 September 19, 2017 J. Rodney Varner Chief Executive Officer Genprex, Inc. 100 Congress Avenue, Suite 2000 Austin, TX 78701 Re: Genprex, Inc. Amendments No. 2 and No. 3 to Registration Statement on Form S -1 Filed September 8 , 2017 and September 15, 2017 File No. 333-219386 Dear Mr. Varner : We have reviewed your amended registration statement and have the following comment. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. 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 circumstan ces 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 the comment, we may have additional comments . Genera l 1. We note the revised disclosure on your cover page that you are offering a minimum of 2,083,334 shares and a maximum of 5,625,000 shares. These amounts conflict with your disclosure throughout that you are offering a minimum of 2,500,000 shares and a maximum of 4,500,000 shares. We also note your statements that you do not intend to close this offering unless you raise minimum gross pr oceeds of $12,500,000, and that the disclo sure in your fee table and Escrow Deposit Agreement contemplate a maximum offering amount of $22,500,000. It appears that you are registering a minimum and maximum aggregate offering amount, rather than a minimum and maximum number of shares, which is not appropriate. Please revise your disclosure throughout the registration statement and your Subscription Agreement and Escrow Deposit Agreement , as necessary, to reflect a set minimum and maximum number of shares to be offered. Refer to Item 501(b)(2) of Regulation S -K and the definition of “amount” in Securities Act Rule 405 for g uidance. J. Rodney Varner Genprex, Inc. September 19, 2017 Page 2 You may contact Frank Wyman at 202 -551-3660 or Lisa Vanjoske at 202 -551-3614 if you have questions regarding comments on the financial statements and related matters. Please contact Dorrie Yale at 202 -551-8776 or Erin Jaskot, Special Counsel, at 202-551-3442 with any other questions . Sincerely, /s/ Erin K. Jaskot, for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Christopher Ozburn — Streusand, Landon & Ozburn, LLP
2017-09-15 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm Correspondence 811 Barton Springs Road Suite 811 Austin, Texas 78704 (512) 236-9908 (512) 236-9904 (fax) ozburn@slollp.com September 15, 2017 United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4546 100 F Street, N.E. Washington, D.C. 20549 Attn: Suzanne Hayes Re: Genprex, Inc. Amendment No. 2 to Registration Statement on Form S-1 Filed September 8, 2017 File No. 333-219386 Dear Ms. Hayes: Enclosed on behalf of our client, Genprex, Inc. (the “Company”), is Amendment No. 3 to Registration Statement on Form S-1 (“Amendment No. 3”). Amendment No. 3 updates the Company’s Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission (the “Commission”) on July 21, 2017 (the “Registration Statement”), as amended by Amendment No. 1 filed with the Commission on August 18, 2017 and by Amendment No. 2 filed with the Commission on September 8, 2017 (“Amendment No. 2”). The copy of Amendment No. 3 that is enclosed with the paper copy of this letter is marked to show changes from Amendment No. 2. The Company respectfully requests the Staff’s assistance in completing the review of Amendment No. 3 as soon as possible. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding the Amendment or this response letter to me at (512) 236-9908. Sincerely, STREUSAND, LANDON & OZBURN, LLP /s/ Christopher J. Ozburn Christopher J. Ozburn cc: J. Rodney Varner, Genprex, Inc. Philip Magri, Magri Law LLC
2017-09-08 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm Response Letter 811 Barton Springs Road Suite 811 Austin, Texas 78704 (512) 236-9908 (512) 236-9904 (fax) ozburn@slollp.com September 8, 2017 United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4546 100 F Street, N.E. Washington, D.C. 20549 Attn: Suzanne Hayes Re: Genprex, Inc. Amendment No. 1 to Registration Statement on Form S-1 Filed August 18, 2017 File No. 333-219386 Dear Ms. Hayes: Enclosed on behalf of our client, Genprex, Inc. (the “Company”), is Amendment No. 2 to Registration Statement on Form S-1 (“Amendment No. 2”). Amendment No. 2 updates the Company’s Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission (the “Commission”) on July 21, 2017 (the “Registration Statement”), as amended by Amendment No. 1 filed with the Commission on August 18, 2017 (“Amendment No. 1”). The copy of Amendment No. 2 that is enclosed with the paper copy of this letter is marked to show changes from Amendment No. 1. Amendment No. 2 is being submitted in response to comments received from the staff of the Commission (the “Staff”) by letter dated September 1, 2017 with respect to the Registration Statement (the “Comment Letter”) as well as to update the disclosure generally. The numbering of the paragraph below corresponds to the numbering in the Comment Letter, the text of which we have incorporated into this response letter for convenience. Except where otherwise indicated, page references in the text of the responses below correspond to the page numbers of the Registration Statement. United States Securities and Exchange Commission September 8, 2017 Page 2 Staff Comments and Company Responses Prospectus Summary Our Pipeline, page 6 1. We acknowledge your revised disclosures and response to prior comment 3. However, although you have some preclinical data, it appears that you have not identified a product candidate and/or target and therefore the program is too preliminary for inclusion in a pipeline table. Please revise to remove the program from the table. We will not object to the related narrative disclosure. Response: In response to the Commission’s comment, the Company has revised the “Our Pipeline” table on pages 6 and 70 to remove from the table the reference to the Company’s 3p21.3 candidate program and the associated arrow. We refer to Comment no. 28 from the Commission’s letter of June 30, 2017, and to the Company’s response to that comment in our letter to the Commission dated July 20, 2017. The full text of the comment and our response are included below as indented text for your convenience: Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Significant Judgments and Estimates, page 49 28. Once you have an estimated offering price range, please explain to us the reasons for any differences between recent valuations of your common stock leading up to the IPO and the midpoint of the estimated offering price range. Response: The Company acknowledges the Staff’s comment and will provide the Staff with that analysis once the estimated offering price has been determined. Further Response of September 8, 2017: Amendment No. 2 includes an estimated offering price range of $4.00 per share to $6.00 per share, with the midpoint of that range being $5.00 per share (the “Midpoint”), all after giving effect to the forward stock split discussed in Amendment No. 2. Each of the issuances by the Company of shares of its capital stock in the twelve months preceding the filing of the Registration Statement (collectively the “Shares”) had an issue price of $5.29 per share, which is greater than the Midpoint, and each of the stock options granted by the Company in the twelve months preceding the filing of the Registration Statement (collectively the “Options”) has an exercise price of $5.29 per share, which is also greater than the Midpoint. There were no other issuances of securities by the Company in the twelve months preceding the filing of the Registration Statement. The issue price of each of the Shares was reached through arms-length negotiations between the Company and the purchasers of those shares, and the exercise price of each of the Options was based upon the issue price of the Shares and was concluded by the Company’s board of directors to be no less than the fair market value of a share of the Company’s common stock on the date of grant of the Options. United States Securities and Exchange Commission September 8, 2017 Page 3 The Company respectfully requests the Staff’s assistance in completing the review of Amendment No. 2 as soon as possible. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding the Amendment or this response letter to me at (512) 236-9908. Sincerely, STREUSAND, LANDON & OZBURN, LLP /s/ Christopher J. Ozburn Christopher J. Ozburn cc: J. Rodney Varner, Genprex, Inc. Philip Magri, Magri Law LLC
2017-09-01 - UPLOAD - Genprex, Inc.
Mail Stop 4546 September 1 , 2017 J. Rodney Varner Chief Executive Officer Genprex, Inc. 100 Congress Avenue, Suite 2000 Austin, TX 78701 Re: Genprex, Inc. Amendment No. 1 to Registration Statement on Form S -1 Filed August 18 , 2017 File No. 333-219386 Dear Mr. Varner : We have reviewed your amended registration statement and have the following comment. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. 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 amendm ent 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 the comment, we may have additional comments. Unless we note otherwise, our references to prior comments are to comments in our August 3, 2017 letter . Prospectus Summary Our Pipeline, page 6 1. We acknowledge your revised disclosures and response to prior comment 3. However, although you have some preclinical data, it appears that you have not identified a product candidate and/or target and therefore the program is too preliminary for inclusion in a pipeline table. Please revise to remove the program from the table. We will not object to the related narrative disclosure . J. Rodney Varner Genprex, Inc. September 1 , 2017 Page 2 You may conta ct Frank Wyman at 202 -551-3660 or Lisa Vanjoske at 202 -551-3614 if you have questions regarding comments on the financial statements and related matters. Please contact Dorrie Yale at 202 -551-8776 or Erin Jaskot, Special Counsel, at 202 -551-3442 with any other questions . Sincerely, /s/ Erin K. Jaskot, for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Christopher Ozburn — Streusand, Landon & Ozburn, LLP
2017-08-18 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm Response Letter 811 Barton Springs Road Suite 811 Austin, Texas 78704 (512) 236-9908 (512) 236-9904 (fax) ozburn@slollp.com August 18, 2017 United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4546 100 F Street, N.E. Washington, D.C. 20549 Attn: Suzanne Hayes Re: Genprex, Inc. Registration Statement on Form S-1 Filed July 21, 2017 File No. 333-219386 Dear Ms. Hayes: Enclosed on behalf of our client, Genprex, Inc. (the “Company”), is Amendment No. 1 to Registration Statement on Form S-1 (the “Amendment”). The Amendment updates the Company’s Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission (the “Commission”) on July 21, 2017 (the “Registration Statement”). The copy of the Amendment that is enclosed with the paper copy of this letter is marked to show changes from the Registration Statement. The Registration Statement is being submitted in response to comments received from the staff of the Commission (the “Staff”) by letter dated August 3, 2017 with respect to the Registration Statement (the “Comment Letter”) as well as to update the disclosure generally. The numbering of the paragraphs below corresponds to the numbering in the Comment Letter, the text of which we have incorporated into this response letter for convenience. Except where otherwise indicated, page references in the text of the responses below correspond to the page numbers of the Registration Statement. United States Securities and Exchange Commission August 18, 2017 Page 2 Staff Comments and Company Responses Prospectus Summary Overview, page 1 1. We note your response to comment 2, however we are unable to locate any disclosure relating to MD Anderson’s preclinical studies combining Oncoprex with MK2206. Please also revise your disclosure to state specifically that you have not conducted any preclinical or clinical studies combining Oncoprex with pembrolizumab and atezolizumab. In addition, in your discussion in the penultimate paragraph on page 2, please clarify that your references to clinical data refer to data from nine patients. Response: The Company has expanded the disclosure on page 80 of the Amendment to include the following disclosure relating to MD Anderson’s preclinical studies combining Oncoprex with MK2206: “In another study, MD Anderson researchers analyzed the effects of TUSC2 re-expression on the sensitivity of tumor cells to the AKT inhibitor MK2206 in vitro and in mice. The AKT pathway is an important intracellular, converging positive regulator of apoptosis. AKT stimulates apoptosis and is frequently dysregulated in cancers, and this has been associated with reduced sensitivity to anti-tumor drugs. The study showed that the combination of TUSC2 transfection with MK2206 treatment suppressed tumor cell viability in vitro and effectively inhibited xenograft tumor growth in vivo more effectively than either agent alone.” Response: The Company has expanded the disclosure on pages 4 and 67 of the Amendment to include the following sentence, indicating that the Company has not conducted any preclinical or clinical studies combining Oncoprex with pembrolizumab or atezolizumab: “We have not conducted any preclinical or clinical studies combining Oncoprex with pembrolizumab or atezolizumab.” Response: As disclosed on pages 4 and 68 of the Amendment, the Company has enrolled a total of 28 patients in its Phase I/II clinical trial of Oncoprex with erlotinib. Of these 28 patients, a total of 18 were enrolled in the Phase I portion of the trial, and a total of 10 were enrolled in the Phase II portion. Three of the 18 Phase I subjects were included in the Phase II portion because they had been given the MTD in the Phase I portion of the trial and thus met the inclusion criteria for the Phase II portion. Of the 10 patients enrolled in the Phase II portion, one was not evaluated; as a result, the Company has data from nine patients in the Phase II portion. However, data collected from the other 15 patients in the Phase I portion did show that Oncoprex can be combined with erlotinib in humans. Accordingly, the Company’s conclusion that Oncoprex can be combined with erlotinib is based on data from a total of 24 patients, composed of 15 patients from the Phase I portion and nine patients from the Phase II portion of our Phase I/II clinical trial. United States Securities and Exchange Commission August 18, 2017 Page 3 Accordingly, the Company has revised the disclosure on pages 3 and 67 of the Amendment as follows to clarify the references to clinical data: “Clinical data from the evaluation of 24 patients in our Phase I/II clinical trial, as well as our preclinical data, indicate that Oncoprex can be combined with the widely used anti-cancer drug erlotinib (marketed as Tarceva® by Genentech, Inc.) in humans.” 2. We refer to your revised disclosure in the second paragraph on page 4. Please balance your discussion regarding your observations from the Phase I trial to explain that the study was not designed to show changes in outcomes. Response: The Company has revised the disclosure on pages 5, 69 and 77 of the Amendment as follows to explain that the Phase I Monotherapy clinical trial was not designed to show changes in outcomes: “In 2012, MD Anderson researchers completed a Phase I clinical trial of Oncoprex as a monotherapy. The primary objective of this Phase I trial was to assess the toxicity of Oncoprex administered intravenously and to determine the MTD and recommended Phase II dose of Oncoprex alone. Secondary objectives were to assess the expression of TUSC2 following intravenous delivery of Oncoprex in tumor biopsies and also to assess the anti-cancer activity of Oncoprex. This trial demonstrated that Oncoprex was well tolerated and established the MTD and the therapeutic dosage for Oncoprex at 0.06 mg/kg administered every 21 days. Although this trial was not designed to show changes in outcomes, a halt in cancer growth was observed in a number of patients, and tumor regressions occurred in primary lung tumors and metastatic cancers in the liver, pancreas, and lymph nodes. In addition, pre- and post-treatment patient biopsies demonstrated that intravenous Oncoprex selectively and preferentially targeted patients’ cancer cells, and suggested that clinical anti-cancer activity was mediated by TUSC2.” Our Pipeline, page 4 3. We acknowledge your revised disclosure in response to comment 7. Please also remove the 3p21.3 candidate program that is shown in the preclinical phase since it does not appear that this program has advanced much beyond the identification of certain genes that may have cancer fighting functions by researchers at MD Anderson Response: Because preclinical studies of several of the 3p21.3 candidate tumor suppressor genes and their effects on lung cancer have been conducted, the Company believes that the inclusion of the 3p21.3 candidate program in the Company’s pipeline illustration is appropriate. Accordingly, the Company has revised the “Our Pipeline” table on pages 6 and 70 to reduce the length of the arrow associated with the Company’s 3p21.3 candidate program. The Company has also expanded the disclosure on pages 92 and 93 of the Amendment to include the following disclosure relating to the MD Anderson’s preclinical studies of candidate tumor suppressor genes in the 3p21.3 chromosome sub-region: United States Securities and Exchange Commission August 18, 2017 Page 4 “Preclinical Studies of Additional 3p21.3 Genes with Cancer-Fighting Properties We have licensed rights to a group of candidate tumor suppressor genes, including 101F6, NPRL2, CACNA2D2, PL6, BLU, RASSF1, HYAL 1 and HYAL2, in addition to TUSC2 (which is also referred to as FUS1), all of which are located in a sub-region of human chromosome 3 known as 3p21.3. Using a number of techniques, MD Anderson researchers and their collaborators have identified these genes as potentially having cancer-fighting characteristics. MD Anderson researchers have subsequently conducted a number of preclinical studies on certain of these genes, particularly 101F6 and NPRL2, as well as TUSC2, both alone and in combination with other compounds, in order to assess their actual effects on NSCLC. Three of these preclinical studies are described below. We plan to support continuing research into the cancer-fighting properties of these and other genes in the 3p21.3 sub-region as an important part of our strategy. Preclinical Study Showing Expression of Several Genes in the Human Chromosome 3p21.3 Sub-region by an Adenovirus Vector Results in Tumor Suppressor Activities in Vitro and in Vivo MD Anderson researchers conducted preclinical studies, both in vitro and in vivo, of several of the licensed genes located in the 3p21.3 sub-region, in order to assess their effects on tumor cell proliferation and apoptosis in human lung cancer cells. The researchers used adenoviral vectors to introduce individual wild-type genes into 3p-deficient tumor xenografts and tumor cell lines. This “forced expression” of the wild-type forms of TUSC2, 101F6, and NPRL2 resulted in inhibition of tumor cell growth by induction of apoptosis and/or alteration of cell cycle pathways in vitro, compared to control. Intratumoral injection of 101F6, TUSC2 and NPRL2 with adenoviral vectors, as well as systemic administration of these genes in an experimental mouse model, suppressed the growth of tumor xenografts (in this case, human tissue grafted onto the mouse model) and inhibited lung metastases. The results of these studies showed that the genes 101F6, NPRL2 and TUSC2 had the most significant anti-cancer effects of the tested genes and were therefore the most promising genes for further study. Preclinical Study Showing that Tumor Suppressor 101F6 and Ascorbate Inhibit Non–Small Cell Lung Cancer Growth One of the promising tumor suppressor gene candidates, 101F6, expresses a protein found in normal lung bronchial epithelial cells and fibroblasts but whose function is impaired in most lung cancers. This protein is involved in the regeneration of ascorbate, a well-known antioxidant that has been tested as a supplemental therapeutic agent for human cancer prevention and therapy. MD Anderson researchers studied the effect of 101F6 in combination with ascorbate on human lung cancer tissue, both in vitro and in vivo. In the in vitro portion of the study, 101F6 was transferred via nanoparticles similar to our Oncoprex nanovesicles, and in combination with ascorbate, selectively targeted cancer cells and inhibited lung cancer cell growth to a greater extent than either 101F6 or ascorbate alone. In vivo, the systemic injection of 101F6 nanoparticles in mouse tail veins, together with the intra-abdominal injection of ascorbate, inhibited both tumor formation and growth in human NSCLC H322 lung cancer xenograft mouse models (P < 0.001) with greater effect than either 101F6 or ascorbate administered alone. United States Securities and Exchange Commission August 18, 2017 Page 5 Preclinical Study Showing NPRL2 Sensitizes Human Non-Small Cell Lung Cancer (NSCLC) Cells to Cisplatin Treatment by Regulating Key Components in the DNA Repair Pathway Another of the promising tumor suppressor gene candidates, NPRL2, interacts with a kinase that is activated by cisplatin, an anti-cancer drug, leading to downstream activation of apoptosis in response to the presence of intracellular high-molecular weight DNA fragments, which themselves result from the breakup of DNA molecules induced by exposure to cisplatin. Mutations in the NPRL2 gene are associated with resistance to this cisplatin-mediated apoptosis. MD Anderson researchers have conducted preclinical studies of NPRL2 with cisplatin in vitro in lung cancer cell cultures and in vivo in an experimental mouse model of chest cavity cancer dissemination. Data from these studies suggest that the systemic introduction of the NPRL2 gene and the resulting expression of the NPRL2 protein in cancer cells activates the DNA damage checkpoint pathway in cisplatin-resistant and NPRL2-negative cells. These studies suggest that the combination of NPRL2 and cisplatin could resensitize cisplatin nonresponders to cisplatin treatment, helping to overcome resistance to cisplatin.” Business Preclinical Studies of TUSC2 in the Immune Response to Cancer, page 80 4. We refer to your revised disclosure regarding the figures on page 83 in response to comment 22. Please further explain the meaning of Figure A. In addition, please add back to the diagrams the labels of each of the figures (e.g., “Figure A”). Response: The Company has revised the diagrams on page 91 of the Amendment to add back the labels of each of the figures. The Company has also expanded the disclosure on pages 89 and 90 of the Amendment to include the following disclosure, in order to further explain the preclinical study and the meaning of Figure A: “Preclinical Study Showing that TUSC2 Immunogene Therapy is Synergistic with Anti-PD1 in Lung Cancer Syngeneic Mouse Models Based on the prolonged responses that were observed in TUSC2 clinical trials, which suggest that TUSC2 may modulate the immune response, and on the fact that checkpoint blockade immunotherapy against PD1 and PD-L1 has yielded durable antitumor activity in a subset of NSCLC patients, MD Anderson researchers conducted a preclinical study to investigate the immune response to TUSC2 in immune cell populations and the synergistic antitumor effect of TUCS2 in combination with anti-PD1 checkpoint blockade in syngeneic mouse NSCLC models. Two Kras-mutant syngeneic mouse models were used to explore the effect of TUSC2+anti-PD1 (+/- anti-CTLA-4) on immune cells infiltration into the tumor micro-environment. Activating Kras mutations are the most common driver mutations in lung adenocarcinomas. Lung cancer with mutant Kras has a poor prognosis, is often resistant to conventional therapy, and readily becomes resistant to targeted therapies with kinase inhibitors. Studies by researchers not at MD Anderson have found that PD1 expression was highly associated with the presence of Kras mutations and that PD-L1 expression was elevated in premalignant Kras-mutant cells, suggesting that Kras mutation may affect the function of the PD1/PD-L1 immune checkpoint pathway. United States Securities and Exchange Commission August 18, 2017 Page 6 The first syngeneic mouse model used a murine lung carcinoma cell line CMT/167-luc with a Kras G12V mutation and a low level of TUSC2 expression, implanted subcutaneously in C57BL/6 mice. The second syngeneic mouse model optimized an aggressive experimental metastatic lung cancer model using 129SvE mice injected with SQ344 lung cancer cells, which contained KrasG12D allele. The SQ344 tumor model was found to be less sensitive to anti-PD1 single agent treatment. The graph below shows the protocol for and results of this preclinical study, in which anti-PD-1, TUSC2 and anti-CTLA-4 treatments were administered in the SQ344 metastatic lung tumor mouse model. Figure A shows that SQ344 tumor cells have less expression of PD-L1 than in the CMT167 model, as determined by flow cytometry. The level of PD-L1 expression in SQ344 cells was only 4.5%, which was significantly lower than the level found in the CMT 167 mouse tumor model (23.7% vs. 4.5%, p < 0.0001), suggesting that SQ344 would respond less strongly to an anti-PD1 agent than the CMT167 model. Figure B shows the protocol for the experiment, in which treatments were administered every three or four days in the mouse tumor cells. Figure C shows the survival of the mice with the lung tumor cells treated with (a) no treatment, (b) a combination of anti-PD-1 and anti-CTLA-4, (c) TUSC2 alone, (d) a combination of TUSC2 and anti-PD-1, and (e) a combination of TUSC2, anti-PD
2017-08-04 - UPLOAD - Genprex, Inc.
Mail Stop 4546 August 3 , 2017 J. Rodney Varner Chief Executive Officer Genprex, Inc. 100 Congress Avenue, Suite 2000 Austin, TX 78701 Re: Genprex, Inc. Registration Statement on Form S-1 Filed July 21, 2017 File No. 333-219386 Dear Mr. Varner : We have reviewed your registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information . If you do not believe our comments apply 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 these comments, we may have additional comments. Unless we note otherwise , our references to prior comments are to comments in our June 30, 2017 letter . Prospectus Summary Overview, page 1 1. We note your response to comment 2, however we are unable to locate any disclosure relating to MD Anderson’s preclinical studies combining Oncoprex with MK 2206. Please also revise your disclosure to state specifically that you have not conducted any preclinical or clinical studies combin ing Oncoprex with pembrolizumab and atezolizumab. In addition, in your discussion in the penultimate paragraph on page 2, please clarify that your references to clinical data refer to data from nine patients. 2. We refer to your revised disclosure in the second paragraph on page 4. Please balance your discussion regarding your observations from the Phase I trial to explain th at the study was not designed to show changes in outcomes . J. Rodney Varner Genprex, Inc. August 3 , 2017 Page 2 Our Pipeline, page 4 3. We acknowledge your revised disclosure in response to comment 7. Please also remove the 3p21.3 candidate program that is shown in the preclinical phase since it does not appear that this program has advanced much beyond the identification of certain genes that may have cancer fighting functions by researchers at MD Anderson. Business Preclinical Studies of TUSC2 in the Immune Response to Cancer, page 80 4. We refer to your revised disclosure regarding the figures on page 83 in response to comment 22. Please further explain the meaning of Figure A. In addition, please add back to the diagrams the labels of each of the figures (e.g., “Figure A”). Intellectual Property, page 84 5. We acknowledge your revised disclosure in response to comment 23. If known, please also include the expected expiration date(s) if the patents are granted for the category of patents reflected in row 5 of your table. 6. Please revise your disclosure to state which patent families relate to Oncoprex. Please also explain how the patents relating to non -viral gene therapy for treatment of hyperproliferative diseases relate to your platform, and whether you expect the expiration of these patents to have a material effect on your business. Licenses and Research Collaborations, page 85 7. We acknowledge your revised disclosures in response to comments 25 and 26. Please clarify whether the term for the MD Anderson license agreement is until the expiration of all patents covered by the agreement. In addition, for the MD Anderson and P53 license agreements, please explain when the last of the patents licensed under each agreement expires. Statements of Operations, page F -4 8. Please refer to prior comment 31 and explain your basis for including common stock equivalents in your calculation of diluted earnings per share and how this presentation conforms to the requirements of ASC 260 -10-45-17. Notes to Financial Statements Note -4 Investment Unit, page F -10 9. Please refer to prior comment 34. We acknowledge the information provided in your response. However, it is unclear whether the notification from the “Trust Company” on J. Rodney Varner Genprex, Inc. August 3 , 2017 Page 3 September 29, 2015 constitutes a permanent legal release from all of your performance obligations under the agreement. Please explain how your accounting treatment for derecognition of the $4.5 million promissory note complied with guidance in ASC 405 - 20-40. In this regard, the notification from the “Trust Company” appears to indicate that not all of the compliance and reporting requirements were suspended and that these suspensions were temporary until your agreement is amended. Please address these matters in your response and as originally requested, explain the factors you considered in concluding that enforcement of these provisions would not be reinstated. In addition, provide a summary of your accounting treatment for this debt extinguishment and the technical guidance upon which you relied. Note 7 -Commitments and Contingencies, page F-15 10. Please refer to prior comment 37 and provide a summary of your accounting treatment for modification of the agreement with the National Institutes of Health, particularly the royalty extinguishment of $120,000 and new contingent milestone payment obl igation of $240,000. Refer us to the technical guidance upon which you relied. 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 o f action by the staff. 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. You may contact Frank Wyman at 202 -551-3660 or Lisa Vanjoske at 202 -551-3614 if you have questions regarding comments on the financial statements and related matters. Please contact Dorrie Yale at 202 -551-8776 or Erin Jaskot, Special Counsel, at 202 -551-3442 with any other questions . Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Christopher Ozburn — Streusand, Landon & Ozburn, LLP
2017-07-20 - CORRESP - Genprex, Inc.
CORRESP 1 filename1.htm 811 Barton Springs Road Suite 811 Austin, Texas 78704 (512) 236-9908 (512) 236-9904 (fax) ozburn@slollp.com July 20, 2017 United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4546 100 F Street, N.E. Washington, D.C. 20549 Attn: Suzanne Hayes Re: Genprex, Inc. Draft Registration Statement on Form S-1 Submitted June 5, 2017 2017 CIK No. 0001595248 Dear Ms. Hayes: Enclosed on behalf of our client, Genprex, Inc. (the “Company”), is a registration statement on Form S-1 (the “Registration Statement”). The Registration Statement updates the Company’s confidential draft registration statement on Form S-1 originally submitted to the Securities and Exchange Commission (the “Commission”) on June 5, 2017 (the “Confidential Draft Registration Statement”). The copy of the Registration Statement that is enclosed with the paper copy of this letter is marked to show changes from the Confidential Draft Registration Statement. The Registration Statement is being submitted in response to comments received from the staff of the Commission (the “Staff”) by letter dated June 30, 2017 with respect to the Confidential Draft Registration Statement (the “Comment Letter”) as well as to update the disclosure generally. The numbering of the paragraphs below corresponds to the numbering in the Comment Letter, the text of which we have incorporated into this response letter for convenience. Except where otherwise indicated, page references in the text of the responses below correspond to the page numbers of the Registration Statement. Staff Comments and Company Responses Prospectus Summary Overview, page 1 1. Please clarify the meaning of any significant scientific or technical terms the first time they are used in order to ensure that lay readers will understand the disclosure. For example, please briefly explain what you mean by “pan-kinase inhibitor,” “tyrosine kinase inhibitor,” “checkpoint inhibitor,” “angiogenesis,” “PI3K/AKT pathway,” and “Ras/MAPK pathway.” United States Securities and Exchange Commission July 20, 2017 Page 2 Response: The Company has expanded the disclosure on pages 1-4 of the Registration Statement, and on other pages, to include definitions of scientific and technical terms, including but not limited to those specifically identified by the Staff. 2. We refer to your statement in the first paragraph of this section and elsewhere in your prospectus that preclinical and clinical data indicate that your “product candidates are synergistic with other cancer drugs” including drugs marketed by large pharmaceutical companies such as Merck & Co., Inc. and Bristol-Myers Squibb Company. However your preclinical and clinical trial disclosure does not appear to discuss a synergistic effect with the specific drugs listed (e.g., nivolumab, pembrolizumab, atezolizumab, ipilimumab, or MK2206). Please revise your disclosure to clearly state whether the trials used the specific drugs listed or drugs that you perceive as equivalent, and if the latter, please explain how the drugs are equivalent. Please also clarify whether any of the companies listed were involved in the trials, and discuss the details of relevant trials, including the number of patients in such trials and the results that demonstrated a synergistic effect. In addition, if true, please disclose that the clinical data is only based on results from nine patients in your ongoing Phase I/II trial evaluating Oncoprex with erlotinib in NSCLC, and the rest are based on preclinical trials. Response: The Company has revised the Registration Statement to use the term “synergistic” only when describing the action of Oncoprex in combination with other lung cancer drugs where the Company has preclinical data for such action. In addition, the Company has revised and expanded the disclosure on pages 2, 56 and 57 of the Registration Statement to explain which of the drugs used in the clinical and preclinical studies were the drugs identified by the Staff and which were equivalent to those drugs, to explain how the equivalents are equivalent to the drugs identified by the Staff and to clarify that none of the companies listed by the Staff were involved in the trials. The Company has also revised the disclosure on pages 66, 72, 73 and 77 of the Registration Statement to discuss the details of the relevant studies, including the number of patients and the results of the studies. The Company has also expanded the disclosure on pages 3, 15, 57 and 78 of the Registration Statement to disclose that the clinical data are based on results from nine patients in the Phase I/II combination trial and that the rest are based on preclinical studies. 3. Please disclose the primary and secondary endpoints of each portion of your combined Phase I/II trial, and whether such endpoints for the Phase I portion were met. Response: The Company has revised and expanded the disclosure on pages 3, 4, 57 and 77 of the Registration Statement to disclose the primary and secondary endpoints of the combined Phase I/II trial and to disclose that such endpoints for the Phase I portion were met. United States Securities and Exchange Commission July 20, 2017 Page 3 4. We refer to your discussion of your Phase I/II trial and the comparison in the first paragraph on page 3 to a trial conducted by Boehringer Ingelheim. Please explain the term “median response duration.” Please also balance your discussion of the other trial here, and elsewhere as appropriate, by disclosing the number of patients who participated in that trial as compared to your ongoing trial and, if true, that the other trial’s endpoint was different. Response: The Company has revised and expanded the disclosure on page 3 of the Registration Statement to explain the term “median response duration” and to provide information about the Boehringer Ingelheim trial, including the number of patients who participated in that trial and its endpoints. 5. We note your statement in the fourth paragraph on page 3 that the Phase I trials demonstrated a “favorable” safety profile of Oncoprex. While we will not object to a statement that your drug candidate was well tolerated, a safety determination is solely within the FDA’s authority. Please remove the statement that the trial results demonstrated a favorable safety profile. Please make similar revisions to the statement on page 62 that your trials indicate that Oncoprex can be administered safely and your statement on page 69 that Oncoprex is safe. Response: The Company has revised the disclosure about the safety profile of Oncoprex on pages 4, 66 and 77 of the Registration Statement as requested by the Staff. Our Pipeline, page 3 6. Please reduce the length of the arrow shown in the first row since we note your statement on page 5 that the Phase II portion of your Phase I/II trial is at an early stage with a limited number of patients enrolled. Please also include a Phase III column in your pipeline table. Response: The Company has revised and expanded the “Our Pipeline” table on pages 5 and 59 to shorten the arrow shown in the first row and to add a Phase III column. 7. Please revise your product pipeline table here and in the Business section to remove programs that are currently listed in the preclinical phase (i.e., Oncoprex to treat various solid tumors, Oncoprex + Immunotherapies and additional 3p21.3 candidates), as it is premature to include them since it does not appear that you have started such programs and they are only contemplated at this time. We further note your disclosure on page 13 that you are actively pursuing development of only one product candidate for non-small cell lung cancer. Response: The Company has revised the “Our Pipeline” table on pages 5 and 59 to delete those programs that are contemplated but not yet in preclinical studies. United States Securities and Exchange Commission July 20, 2017 Page 4 Risks Relating to Our Business, page 5 8. Please expand your discussion in the fourth bullet to explain that prior to the combined trial, Oncoprex has previously been tested in only one prior Phase I trial involving 31 patients and which tested Oncoprex as a monotherapy. Response: The Company has expanded the disclosure on page 6 of the Registration Statement in accordance with the comment made by the Staff. 9. Please add a bullet to discuss the continued concentration of ownership by management after the offering. Response: The Company has expanded the disclosure on page 7 of the Registration Statement in accordance with the comment made by the Staff. Implications of Being an Emerging Growth Company, page 6 10. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. Response: The Company acknowledges the Staff’s request and advises the Staff that, to date, no written communications, as defined in Rule 405 under the Securities Act, have been presented by the Company, or by anyone authorized to act on the Company’s behalf, to potential investors. The Company intends to provide the Staff supplementally with copies of all such written communications presented to potential investors in reliance on Section 5(d) of the Securities Act as promptly as practicable following such presentation, if any. Risk Factors The intellectual property rights we have licensed . . . , page 29 11. We note that there is a risk that the intellectual property rights you licensed from MD Anderson may be non-exclusive or void if a funding agreement related to the licensed technology between MD Anderson and the US government exists. Please tell us whether you are aware of such a funding agreement or whether you have spoken to MD Anderson about the existence of an agreement. To the extent you are aware of such an agreement, please revise your risk factor accordingly. Response: MD Anderson has informed us that certain of the technologies covered by the MD Anderson License Agreement were developed pursuant to one or more funding agreements with a U.S. government entity. The Company has therefore revised and expanded the referenced risk factor on page 30 of the Registration Statement to better explain the legal basis for the potential governmental rights to the licensed intellectual property rights. United States Securities and Exchange Commission July 20, 2017 Page 5 Certain provisions in our organizational documents. . ., page 41 12. We refer to your last bullet of this risk factor. Please expand your discussion of the risks of your exclusive forum provision to include a discussion that such a provision may limit a shareholder’s ability to bring a claim in a judicial forum that it finds favorable for such disputes and may discourage lawsuits with respect to such claims. Response: The Company has expanded the risk factor on page 43 of the Registration Statement in accordance with the comment made by the Staff. Use of Proceeds, page 44 13. Please clarify what is included by the line item “research and development costs” and whether it relates to either of the trials currently listed in the Use of Proceeds section. Please also consider adding disclosure that assumes you raise an amount in between the minimum and maximum offering amounts. Response: The Company has expanded the disclosure on page 45 of the Registration Statement to clarify what is included in the line item “research and development costs” and the trials to which such costs relate. In addition, the Company has added disclosure that assumes it raises an amount in between the minimum and maximum offering amounts. 14. Regarding your statement in the third paragraph of this section that you estimate you will require at least the specified amount of additional financing to “complete the trials,” please clarify the amount needed to complete the trial for Oncoprex combined with immunotherapy if you only receive the minimum and if you receive the maximum amount in the offering. Please also tell us whether you will be able to complete the Phase II trial for the Oncoprex and erlotinib trial if you only receive the minimum amount of the offering. Response: The Company has expanded the disclosure on page 43 of the Registration Statement to clarify the amount needed to complete the referenced trials if it receives the minimum and the maximum amounts in the offering, and to explain that it will be able to complete the Phase II trial of Oncoprex and erlotinib if it receives only the minimum amount of the offering. United States Securities and Exchange Commission July 20, 2017 Page 6 Business Overview, page 54 15. Please revise the illustration on page 55 so that it more clearly demonstrates the multimodal mechanism of action of Oncoprex. Response: The Company has deleted this illustration, as the mechanisms of action of Oncoprex are better illustrated by the illustrations on pages 62, 63 and 65 of the Registration Statement. Preclinical and Clinical Development, Rationale and Strategy Phase I Monotherapy Clinical Trial, page 64 16. Please disclose how “disease control” was defined in the Phase 1 Monotherapy trial. Response: The Company has expanded the disclosure on pages 3 and 57 of the Registration Statement to include an explanation of “disease control.” 17. Please disclose whether there were any serious adverse effects of the trial. Response: The Company has expanded the disclosure on page 69 of the Registration Statement to include disclosure of the reported serious adverse events observed in the trial. 18. In your discussion of the results of the Phase I monotherapy trial, please disclose whether the results were statistically significant, provide an explanation of the term and discuss how statistical significance relates to the FDA’s evidentiary standards of efficacy. Response: The Company has revised the disclosure on page 72 of the Registration Statement to explain the term “statistically significant” and to explain its relationship to FDA standards of efficacy, and to avoid the use of the terms “significant” and “statistically significant” in connection with the Phase I monotherapy trial, since those concepts were not directly applicable to that trial. 19. Please enlarge the graphs on pages 66 and 75 and figures D, F, G, and H on page 76 to be legible. Response: The Company has enlarged and revised the graphs on pages 71, 82 and 83 of the Registration Statement to make them legible. United States Securities and Exchange Commission July 20, 2017 Page 7 Phase I/II Combination Clinical Trial. . ., page 70 20. We note your statement in the second paragraph on page 72 that you are seeking FDA guidance regarding expanded enrollment in the trial with a view toward seeking accelerated approval. Please disclose here the number of patients contemplated by the current trial protocol, the number of patients currently participating in the Phase II trial, and how long you expect the trial to take under the current protocol. Response: The Company has expanded the disclosure on pages 77, 78 and 80 of the Registration Statement to disclose the number of patients contemplated by the protocol, the number of patients currently participating in the Phase II trial and to discuss the expected duration of the trial, based on certain assumptions. Preclinical Studies of TUSC2 in the Immune Response to Cancer, page 72 21. Please describe what the numbers on the vertical axis in Figure 7 on page 73 represent. Response: The Company has deleted Figure 7 because its information is better shown by the graph on page 81. 22. Please expand your narrative disclosure to discuss w
2017-06-30 - UPLOAD - Genprex, Inc.
Mail Stop 4 546 June 30, 2017 J. Rodney Varner Chief Executive Officer Genprex, Inc. 100 Congress Avenue, Suite 2000 Austin, TX 78701 Re: Genprex, Inc. Draft Registration Statement on Form S -1 Submitted June 5, 2017 CIK No. 0001595248 Dear Mr. Varner : We have reviewed your draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by providing th e requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appro priate, please tell us why in your response. After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. Prospectus Summary Overview, page 1 1. Please clarify the meaning of any significant scientific or technical terms the first time they are used in order to ensure that lay readers will understand the disclosure. For example, please briefly explain what you mean by “pan -kinas e inhibitor,” “tyrosine kinase inhibitor,” “checkpoint inhibitor,” “angiogenesis,” “PI3K/AKT pathway,” and “Ras/MAPK pathway.” 2. We refer to your statement in the first paragraph of this section and elsewhere in your prospectus that preclinical and clinical data indicate that your “product candidates are synergistic with other cancer drugs ” including drugs marketed by large pharmaceutical companies such as Merck & Co., Inc. and Bristol -Myers Squibb Company. However J. Rodney Varner Genprex, Inc. June 30, 2017 Page 2 your preclinical and clinical trial disclo sure does not appear to discuss a synergistic effect with the specific drugs listed (e.g., nivolumab , pembrolizumab , atezolizumab, ipilimumab , or MK2206) . Please revise your disclosure to clearly state whether the trials used the specific drugs listed or drugs that you perceive as equivalent , and if the latter, please explain how the drugs are equivalent . Please also clarify whether any of the companies listed were involved in the trials , and discuss the details of relevant trials, including the number of patients in such trials and the results that demonstrated a synergistic effect. In addition, if true, please disclose that the clinical data is only based on results from nine patients in you r ongoing Phase I/II trial evaluating On coprex with erlotinib in NSCLC , and the rest are based on preclinical trials . 3. Please disclose the primary and secondary endpoints of each portion of your combined Phase I/II trial, and whether such endpoints for the Phase I portion were met. 4. We refer to your discussion of your Phase I/II trial and the comparison in the first paragraph on page 3 to a trial conducted by Boehringer Ingelheim. Please explain the term “median response duration.” Please also balance your disc ussion of the other trial here, and elsewhere as appropriate, by disclosing the number of patients who participated in that trial as compared to your ongoing trial and, if true, that the other trial’s endpoint was different. 5. We note your statement in the fourth paragraph on page 3 that the Phase I trials demonstrated a “favorable” safety profile of Oncoprex. While we will not object to a statement that your drug candidate was well tolerated, a safety determination is solely within the FDA’s authority. Pl ease remove the statement that the trial results demonstrated a favorable safety profile. Please make similar revisions to the statement on page 62 that your trials indicate that Oncoprex can be administered safely and your statement on page 69 that Oncop rex is safe. Our Pipeline, page 3 6. Please reduce the length of the arrow shown in the first row since we note your statement on page 5 that the Phase II portion of your Phase I/II trial is at an early stage with a limited number of patients enrolled. Ple ase also include a Phase III column in your pipeline table. 7. Please revise your product pipeline table here and in the Business section to remove programs that are currently listed in the preclinical phase (i.e., Oncoprex to treat various solid tumors, Onc oprex + Immunotherapies and additional 3p21.3 candidates), as it is premature to include them since it does not appear that you have started such programs and they are only contemplated at this time. We further note your disclosure on page 13 that you are actively pursuing development of only one product candidate for non -small cell lung cancer. J. Rodney Varner Genprex, Inc. June 30, 2017 Page 3 Risks Relating to Our Business, page 5 8. Please expand your discussion in the fourth bullet to explain that prior to the combined trial, Oncoprex has previously be en tested in only one prior Phase I trial involving 31 patients and which tested Oncoprex as a monotherapy. 9. Please add a bullet to discuss the continued concentration of ownership by management after the offering. Implications of Being an Emerging Growth Company, page 6 10. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Secti on 5(d) of the Securities Act, whether or not they retain copies of the communications. Risk Factors The intellectual property rights we have licensed . . . , page 29 11. We note that there is a risk that the intellectual property rights you licensed from M D Anderson may be non -exclusive or void if a funding agreement related to the licensed technology between MD Anderson and the US government exists. Please tell us whether you are aware of such a funding agreement or whether you have spoken to MD Anderson about the existence of an agreement. To the extent you are aware of such an agreement, please revise your risk factor accordingly. Certain provisions in our organizational documents. . ., page 41 12. We refer to your last bullet of this risk factor. Please expand your discussion of the risks of your exclusive forum provision to include a discussion that such a provision may limit a shareholder’s ability to bring a claim in a judicial forum that it finds favorable for such disputes and may discourage lawsuit s with respect to such claims. Use of Proceeds, page 44 13. Please clarify what is included by the line item “research and development costs” and whether it relates to either of the trials currently listed in the Use of Proceeds section. Please also conside r adding disclosure that assumes you raise an amount in between the minimum and maximum offering amounts. 14. Regarding your statement in the third paragraph of this section that you estimate you will require at least the specified amount of additional financ ing to “complete the trials,” please clarify the amount needed to complete the trial for Oncoprex combined with J. Rodney Varner Genprex, Inc. June 30, 2017 Page 4 immunotherapy if you only receive the minimum and if you receive the maximum amount in the offering. Please also tell us whether you will be ab le to complete the Phase II trial for the Oncoprex and erlotinib trial if you only receive the minimum amount of the offering. Business Overview, page 54 15. Please revise the illustration on page 55 so that it more clearly demonstrates the multimodal mechanism of action of Oncoprex. Preclinical and Clinical Development, Rationale and Strategy Phase I Monotherapy Clinical Trial, page 64 16. Please disclose how “ disease control” was defined in the Phase 1 Monotherapy trial. 17. Please disclose whether there were any serious adverse effects of the trial . 18. In your discussion of the results of the Phase I monotherapy trial, please disclose whether the results were stati stically significant, provide an explanation of the term and discuss how statistical significance relates to the FDA’s evidentiary standards of efficacy. 19. Please enlarge the graphs on pages 66 and 75 and figures D, F, G, and H on page 76 to be legible. Phase I/II Combination Clinical Trial. . ., page 70 20. We note your statement in the second paragraph on page 72 that you are seeking FDA guidance regarding expanded enrollment in the trial with a view toward seeking accelerated approval. Please disclose here the number of patients contemplated by the current trial protocol, the number of patients currently participating in the Phase II trial, and how long you expect the trial to take under the current protocol. Preclinical Studies of TUSC2 in the Immune Resp onse to Cancer, page 72 21. Please describe what the numbers on the vertical axis in Figure 7 on page 73 represent. 22. Please expand your narrative disclosure to discuss what graphs A, B, and H on page 76 represent. J. Rodney Varner Genprex, Inc. June 30, 2017 Page 5 Intellectual Property, page 77 23. Please expand your disclosure regarding the patents licensed from MD Anderson and UTSWMC. For all material patents, including patents covering use of the TUSC2 gene for treatment of cancer, please disclose the type of patent protection, the jurisdiction, and the patent expiration dates. 24. We note your disclosure that you hold a non -exclusive license from NIH to 15 patents that will expire in August 2017. Please disclose the types of patents these represent, how they relate to your platform, and whether yo u expect the expiration of these patents to have a material effect on your business. Licenses and Research Collaborations, page 77 25. Please disclose the term and termination provisions of the amended MD Anderson license agreement, Clinical Study Agreement and the collaboration agreements with IRI. Please also disclose all upfront fees paid by you under these agreements. 26. Please disclose the term, termination provisions and any material payment provisions of the P53 license agreement. 27. Please explain the si gnificance of the Sponsored Research Agreement with MD Anderson dated September 14, 2010. Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Significant Judgments and Estimates, page 49 28. Once you have an estimated offering price range, please explain to us the reasons for any differences between recent valuations of your common stock leading up to the IPO and the midpoint of the estimated offering price range. Management Executive Officers, page 92 29. Please clarify the biographical information of your executive officers so that it is clear whether they are currently working full time for you. If your executive officers are working for you only on a part -time basis, please add a risk factor disclosing it. Security Ownership of Certain Beneficial Owners and Management, page 112 30. Please add a footnote to explain that Domecq Sebastian, LLC is affiliated with you r former director. Please also identify the natural person(s) who currently have voting and investment control of the shares held by Domecq Sebastian, LLC and Texas Treasury Safekeeping Trust Company. J. Rodney Varner Genprex, Inc. June 30, 2017 Page 6 Statements of Operations, page F -4 31. Please explain to us why your presentation of net loss per share does not conform to the requi rements of ASC 260. Explain why you include preferred shares in the computation and why you don’t provide basic net loss per share. Revise your presentation accordingly. Notes to Financial Statements Note 2 -Summary of Significant Accounting Policies Intellectual Property, page F -9 32. Please explain the nature of costs capitalized as intellectual property and those business activities reflected in “costs incurred for patent prosecution,” as well as your basis for capitalizing these costs. Refer us to the tec hnical guidance upon which you relied. Revise your disclosure accordingly. Accounting for Stock -Based Compensation, page F -9 33. You state that stock -based compensation is recognized over the periods in which the related services are rendered. Please explain your consideration of related vesting periods in determining your accounting treatment. Refer us to the technical guidance upon which you relied. Revise your disclosure accordingly. Note -4 Investment Unit, page F -10 34. Please explain to us your basis for d etermining the value of the $4.5 million promissory note to be zero at December 31, 2015 and 2016 and March 31, 2017, particularly your evaluation of the terms governing the contingent repayment obligation. Also, refer us to the legal documents supporting TETF’s suspension of its default provision enforcement and its statement that your failure to meet the Texas residency requirement would not result in an event of default. Also, provide your analysis of the likelihood that its enforcement of these provisio ns will not be reinstated. Refer us to the technical guidance upon which you have relied. Revise the disclosure as necessary. Clarify in the disclosure if the warrant was exercised for 80% of the per share transaction value in the qualifying financing tr ansaction or if the warrant was exercised for $0.001 per share. Note 5 -Equity, page F -11 35. You appear to have issued common stock that is voting and common stock that is non - voting, while on page 114 you state that “our common stock is entitled to one vote for each share held.” Please explain this apparent inconsistency and provide a description of all rights held by each class of common stock and the amounts that were outstanding for each period presented. Revise your disclosure accordingly. J. Rodney Varner Genprex, Inc. June 30, 2017 Page 7 Note 7 -Commit ment and Contingencies, page F -15 36. Please expand your disclosure of the IRI commitment to include relevant information, such as the terms governing your royalty obligation as described on page 28. 37. Please tell us the terms governing your payment obligatio n to the National Institutes of Health of $191,393 and where this obligation was classified on your balance sheets at December 31, 2016 and March 31, 2017. Revise your disclosure accordingly. Part II Item 17. Undertakings 38. Please also include the undertak ings set forth in Item 512(a)(2) and (3) of Regulation S-K. You may contact Frank Wyman at 202-551-3660 or Lisa Vanjoske at 202-551-3614 if you have questions regarding comments on the financial statements and related matters. Please contact Dorrie Yale at 202-551-8776 or Erin Jaskot, S pecial Counsel, at 202 -551-3442 with any other questions. Sincerely, /s/ Erin K. Jaskot, for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Christopher Ozburn — Streusand, Landon & Ozburn, LLP