Loaded from persisted store.
Threads
All Filings
SEC Comment Letters
Company Responses
Letter Text
Monopar Therapeutics
Response Received
1 company response(s)
High - file number match
↓
Monopar Therapeutics
Awaiting Response
0 company response(s)
High
Monopar Therapeutics
Response Received
1 company response(s)
High - file number match
↓
Company responded
2025-07-22
Monopar Therapeutics
References: July 16, 2025
Monopar Therapeutics
Response Received
1 company response(s)
High - file number match
↓
Monopar Therapeutics
Response Received
1 company response(s)
High - file number match
↓
Monopar Therapeutics
Response Received
1 company response(s)
High - file number match
↓
Monopar Therapeutics
Response Received
8 company response(s)
High - file number match
↓
Company responded
2019-09-30
Monopar Therapeutics
Summary
Generating summary...
↓
Company responded
2019-10-02
Monopar Therapeutics
Summary
Generating summary...
↓
Company responded
2019-10-02
Monopar Therapeutics
Summary
Generating summary...
↓
Company responded
2019-11-05
Monopar Therapeutics
Summary
Generating summary...
↓
Company responded
2019-11-06
Monopar Therapeutics
Summary
Generating summary...
↓
Company responded
2019-11-07
Monopar Therapeutics
Summary
Generating summary...
↓
Company responded
2019-12-16
Monopar Therapeutics
Summary
Generating summary...
↓
Company responded
2019-12-17
Monopar Therapeutics
Summary
Generating summary...
Monopar Therapeutics
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-12-13
Monopar Therapeutics
Summary
Generating summary...
Monopar Therapeutics
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2017-12-06
Monopar Therapeutics
Summary
Generating summary...
↓
Company responded
2018-12-11
Monopar Therapeutics
References: December 3, 2018
Summary
Generating summary...
Monopar Therapeutics
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-12-03
Monopar Therapeutics
Summary
Generating summary...
Monopar Therapeutics
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2018-01-09
Monopar Therapeutics
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-05 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2025-09-04 | SEC Comment Letter | Monopar Therapeutics | DE | 333-289947 | Read Filing View |
| 2025-07-25 | SEC Comment Letter | Monopar Therapeutics | DE | 001-39070 | Read Filing View |
| 2025-07-22 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2025-07-16 | SEC Comment Letter | Monopar Therapeutics | DE | 001-39070 | Read Filing View |
| 2025-01-23 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2025-01-22 | SEC Comment Letter | Monopar Therapeutics | DE | 333-284304 | Read Filing View |
| 2022-12-29 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2022-12-28 | SEC Comment Letter | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2020-01-10 | SEC Comment Letter | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2020-01-10 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2019-12-17 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2019-12-16 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2019-11-07 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2019-11-06 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2019-11-05 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2019-10-02 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2019-10-02 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2019-09-30 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2019-08-26 | SEC Comment Letter | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2018-12-13 | SEC Comment Letter | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2018-12-11 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2018-12-03 | SEC Comment Letter | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2018-01-09 | SEC Comment Letter | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2017-12-06 | SEC Comment Letter | Monopar Therapeutics | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-04 | SEC Comment Letter | Monopar Therapeutics | DE | 333-289947 | Read Filing View |
| 2025-07-25 | SEC Comment Letter | Monopar Therapeutics | DE | 001-39070 | Read Filing View |
| 2025-07-16 | SEC Comment Letter | Monopar Therapeutics | DE | 001-39070 | Read Filing View |
| 2025-01-22 | SEC Comment Letter | Monopar Therapeutics | DE | 333-284304 | Read Filing View |
| 2022-12-28 | SEC Comment Letter | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2020-01-10 | SEC Comment Letter | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2019-08-26 | SEC Comment Letter | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2018-12-13 | SEC Comment Letter | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2018-12-03 | SEC Comment Letter | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2018-01-09 | SEC Comment Letter | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2017-12-06 | SEC Comment Letter | Monopar Therapeutics | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-05 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2025-07-22 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2025-01-23 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2022-12-29 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2020-01-10 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2019-12-17 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2019-12-16 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2019-11-07 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2019-11-06 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2019-11-05 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2019-10-02 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2019-10-02 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2019-09-30 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
| 2018-12-11 | Company Response | Monopar Therapeutics | DE | N/A | Read Filing View |
2025-09-05 - CORRESP - Monopar Therapeutics
CORRESP 1 filename1.htm mnpr20250904_corresp.htm Monopar Therapeutics Inc. 1000 Skokie Blvd., Suite 350 Wilmette, Illinois 60091 September 5, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Monopar Therapeutics Inc. Registration Statement on Form S-3 File No. 333-289947 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “ Act ”), Monopar Therapeutics Inc. (the “ Company ”) hereby requests that the effective date of the above-referenced registration statement (the “ Registration Statement ”) be accelerated to September 9, 2025, at 5:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Baker & Hostetler LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its obligations under the Act. We request that we be notified of such effectiveness by a telephone call to John J. Harrington of Baker & Hostetler LLP, counsel to the Company, at (216) 861-6697 and that such effectiveness also be confirmed in writing. Very truly yours, Monopar Therapeutics Inc. By: /s/ Chandler D. Robinson Chandler D. Robinson Chief Executive Officer
2025-09-04 - UPLOAD - Monopar Therapeutics File: 333-289947
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 4, 2025 Chandler Robinson Chief Executive Officer Monopar Therapeutics Inc. 1000 Skokie Blvd., Suite 350 Wilmette, IL 60091 Re: Monopar Therapeutics Inc. Registration Statement on Form S-3 Filed August 29, 2025 File No. 333-289947 Dear Chandler Robinson: 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: John Harrington </TEXT> </DOCUMENT>
2025-07-25 - UPLOAD - Monopar Therapeutics File: 001-39070
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 25, 2025 Quan Vu Chief Financial Officer Monopar Therapeutics Inc. 1000 Skokie Blvd., Suite 350 Wilmette, IL 60091 Re: Monopar Therapeutics Inc. Form 10-K for Fiscal Year Ended December 31, 2024 File No. 001-39070 Dear Quan Vu: We have completed our review of your filing. 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 </TEXT> </DOCUMENT>
2025-07-22 - CORRESP - Monopar Therapeutics
CORRESP 1 filename1.htm mnpr20250721_corresp.htm July 22, 2025 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Tyler Howes Alan Campbell Re: Monopar Therapeutics Inc. Form 10-K for Fiscal Year Ended December 31, 2024 Filed March 31, 2025 File No. 001-39070 To the addressees set forth above: On behalf of Monopar Therapeutics Inc. (the “Company”), set forth below is the Company’s response to the comments received from the Staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission in its letter to the Company dated July 16, 2025, relating to the Company’s 10-K for the fiscal year ended December 31, 2024, filed on March 31, 2025 (the “Form 10-K”). For the Staff’s convenience, each response below is preceded by the exact text of the corresponding comment. Form 10-K for Fiscal Year Ended December 31, 2024 Item 1. Business Our Product Pipeline, page 7 1. We note your inclusion of two programs named “Early Pipeline” in your pipeline table on page 7. Given the limited disclosure related to these two programs, please tell us why they are sufficiently material to your business to warrant inclusion in your pipeline table. In future filings, please revise to provide more fulsome disclosure related to these two programs, including any development steps you have undertaken and disclose the individual compounds used in each program. Alternatively, remove any programs that are not currently material to your business from your pipeline table in future filings. Response to Comment No. 1: The Company respectfully acknowledges the Staff’s comment and advises the Staff that in future filings, beginning with its Form 10-Q for the quarter ended June 30, 2025, the Company will remove from its pipeline table any programs that are not currently material to its business, including the two “Early Pipeline” programs referenced above. MNPR-101 for Radiopharmaceutical Use, page 8 2. Please remove your reference here and on page 57 to MNPR-101 being a “first-in-class” monoclonal antibody that targets the urokinase plasminogen activator receptor in future filings, as this statement is speculative in light of the current regulatory status of your clinical candidate. Response to Comment No. 2: The Company respectfully acknowledges the Staff’s comment and advises the Staff that in future filings, beginning with its Form 10-Q for the quarter ended June 30, 2025, the Company will remove any references to MNPR-101 being a “first-in-class” monoclonal antibody that targets the urokinase plasminogen activator receptor. License, Development and Collaboration Agreements Alexion, AstraZeneca Rare Disease, page 10 3. Please revise future filings to disclose all the material terms of your Alexion licensing agreement including the aggregate amount paid to date under this agreement and any term and termination provisions. Please also ensure that you limit any discussion of royalty rate ranges payable under this agreement to ten percentage points in future filings. Response to Comment No. 3: The Company respectfully acknowledges the Staff’s comment and advises the Staff that in future filings, beginning with its Form 10-Q for the quarter ended June 30, 2025, the Company will: (i) disclose all material terms of its Alexion licensing agreement, including the aggregate amount paid to date under this agreement and any term and termination provisions; and (ii) limit any discussion of royalty rate ranges payable under this agreement to a range not exceeding ten percentage points. The Company further respectfully acknowledges that it and its management are responsible for the accuracy and adequacy of the disclosures in its filings, notwithstanding any review, comments, action or absence of action by the Staff. Sincerely, /s/ Quan Vu Quan Vu Chief Financial Officer Monopar Therapeutics Inc. cc: John Harrington, Baker & Hostetler LLP Sean Cheatle, Baker & Hostetler LLP
2025-07-16 - UPLOAD - Monopar Therapeutics File: 001-39070
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 16, 2025 Quan Vu Chief Financial Officer Monopar Therapeutics 1000 Skokie Blvd., Suite 350 Wilmette, IL 60091 Re: Monopar Therapeutics Form 10-K for Fiscal Year Ended December 31, 2024 Filed March 31, 2025 File No. 001-39070 Dear Quan Vu: We have reviewed your filing and have the following comments. Please respond to this letter 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 a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Form 10-K for Fiscal Year Ended December 31, 2024 Item 1. Business Our Product Pipeline, page 7 1. We note your inclusion of two programs named "Early Pipeline" in your pipeline table on page 7. Given the limited disclosure related to these two programs, please tell us why they are sufficiently material to your business to warrant inclusion in your pipeline table. In future filings, please revise to provide more fulsome disclosure related to these two programs, including any development steps you have undertaken and disclose the individual compounds used in each program. Alternatively, remove any programs that are not currently material to your business from your pipeline table in future filings. MNPR-101 for Radiopharmaceutical Use, page 8 2. Please remove your reference here and on page 57 to MNPR-101 being a "first-in- class" monoclonal antibody that targets the urokinase plasminogen activator receptor in future filings, as this statement is speculative in light of the current regulatory status July 16, 2025 Page 2 of your clinical candidate. License, Development and Collaboration Agreements Alexion, AstraZeneca Rare Disease, page 10 3. Please revise future filings to disclose all the material terms of your Alexion licensing agreement including the aggregate amount paid to date under this agreement and any term and termination provisions. Please also ensure that you limit any discussion of royalty rate ranges payable under this agreement to ten percentage points in future 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. Please contact Tyler Howes at 202-551-3370 or Alan Campbell at 202-551-4224 if you have questions regarding comments. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2025-01-23 - CORRESP - Monopar Therapeutics
CORRESP 1 filename1.htm mnpr20250122_corresp.htm Monopar Therapeutics Inc. 1000 Skokie Blvd., Suite 350 Wilmette, Illinois 60091 January 23, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Monopar Therapeutics Inc. Registration Statement on Form S-3 File No. 333-284304 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Monopar Therapeutics Inc. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to January 27, 2025, at 5:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Baker & Hostetler LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its obligations under the Act. We request that we be notified of such effectiveness by a telephone call to John J. Harrington of Baker & Hostetler LLP, counsel to the Company, at (216) 861-6697 and that such effectiveness also be confirmed in writing. Very truly yours, Monopar Therapeutics Inc. By: /s/ Chandler D. Robinson Chandler D. Robinson Chief Executive Officer
2025-01-22 - UPLOAD - Monopar Therapeutics File: 333-284304
January 22, 2025
Chandler Robinson
Chief Executive Officer
Monopar Therapeutics Inc.
1000 Skokie Blvd., Suite 350
Wilmette, IL 60091
Re:Monopar Therapeutics Inc.
Registration Statement on Form S-3
Filed January 15, 2025
File No. 333-284304
Dear Chandler Robinson:
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 Tyler Howes at 202-551-3370 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:John J. Harrington, Esq.
2022-12-29 - CORRESP - Monopar Therapeutics
CORRESP 1 filename1.htm mnpr_corresp Monopar Therapeutics Inc. 1000 Skokie Blvd., Suite 350 Wilmette, Illinois 60091 December 29, 2022 VIA EDGAR US Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: Monopar Therapeutics Inc. Registration Statement on Form S-3 File No. 333-268935 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Monopar Therapeutics Inc. (the “Company”) hereby respectfully requests that the above-referenced Registration Statement be declared effective at 9:00 a.m., Eastern time, on January 4, 2023 or as soon thereafter as practicable, or such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance. Please contact John Harrington of Baker & Hostetler LLP at (216) 861-6697 with any questions regarding the foregoing and to confirm the effectiveness of the Registration Statement. Very truly yours, Monopar Therapeutics Inc. By: /s/ Chandler D. Robinson Chandler D. Robinson Chief Executive Officer
2022-12-28 - UPLOAD - Monopar Therapeutics
United States securities and exchange commission logo
December 28, 2022
Chandler D. Robinson
Chief Executive Officer
Monopar Therapeutics Inc.
1000 Skokie Blvd., Suite 350
Wilmette, IL 60091
Re:Monopar Therapeutics
Registration Statement on Form S-3
Filed December 21, 2022
File No. 333-268935
Dear Chandler D. Robinson:
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: John J. Harrington
2020-01-10 - UPLOAD - Monopar Therapeutics
January 10, 2020
Chandler D. Robinson, MD MBA MSc
Chief Executive Officer
Monopar Therapeutics
1000 Skokie Blvd., Suite 350
Wilmette, IL 60091
Re:Monopar Therapeutics Inc.
Registration Statement on Form S-3
Filed January 3, 2020
File No. 333-235791
Dear Dr. Robinson:
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: Robert Rupp, Esq.
2020-01-10 - CORRESP - Monopar Therapeutics
CORRESP 1 filename1.htm Blueprint Monopar Therapeutics Inc. 1000 Skokie Blvd., Suite 350 Wilmette, Illinois 60091 January 10, 2020 VIA EDGAR US Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: Monopar Therapeutics Inc. Registration Statement on Form S-3 File No. 333-235791 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Monopar Therapeutics Inc. (the “Company”) hereby respectfully requests that the above-referenced Registration Statement be declared effective at 9:00 a.m., Eastern time, on January 13, 2020 or as soon thereafter as practicable, or such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance. Please contact John Harrington of Baker & Hostetler LLP at (216) 861-6697 with any questions regarding the foregoing and to confirm the effectiveness of the Registration Statement. Very truly yours, Monopar Therapeutics Inc. By: _/s/ Chandler D. Robinson Chandler D. Robinson Chief Executive Officer
2019-12-17 - CORRESP - Monopar Therapeutics
CORRESP
1
filename1.htm
Blueprint
JonesTrading Institutional Services LLC
Third Avenue, 23rd Floor
New York, NY 10017
December 17, 2019
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, N.E.
Washington, D.C. 20549
Re:
Monopar Therapeutics
Inc. (the “Company”)
Registration Statement on Form S-1
File No. 333-233303
Ladies and Gentlemen:
In
accordance with Rule 461 under the Securities Act of 1933, as
amended (the “Act”), and as representative of the
several underwriters of the Company’s proposed public
offering, we wish to advise you that we hereby join with the
Company’s request that the effective date of the
above-referenced Registration Statement be accelerated so that the
same will become effective at 4:00PM ET on December 18, 2019, or as
soon thereafter as is practicable.
Pursuant
to Rule 460 under the Act, we wish to advise you that we have
distributed 34 copies of the preliminary prospectus dated December
13, 2019, through the date hereof, to prospective underwriters,
institutional investors, dealers and others.
We,
the undersigned, as representative of the several underwriters,
have complied and will continue to comply, and we have been
informed by the participating underwriters and dealers that they
have complied and will continue to comply, with the requirements of
Rule 15c2-8 under the Securities Exchange Act of 1934, as
amended.
Very
truly yours,
JonesTrading Institutional Services LLC
By:
/s/
Burke
Cook
Name:
Burke
Cook
Title:
General
Counsel
2019-12-16 - CORRESP - Monopar Therapeutics
CORRESP
1
filename1.htm
Blueprint
Monopar Therapeutics Inc.
1000
Skokie Blvd., Suite 350
Wilmette,
Illinois 60091
December
16, 2019
VIA EDGAR
US
Securities and Exchange Commission
Division
of Corporation Finance
100 F
Street, NE
Washington,
DC 20549
Re:
Monopar Therapeutics Inc.
Registration Statement on Form
S-1
File No. 333-233303
Ladies
and Gentlemen:
Pursuant to Rule
461 under the Securities Act of 1933, as amended, Monopar
Therapeutics Inc. (the “Company”) hereby respectfully
requests that the above-referenced Registration Statement be
declared effective at 4:00 p.m., Eastern time, on December 18, 2019
or as soon thereafter as practicable, or such later time as the
Company or its counsel may orally request via telephone call to the
staff of the Division of Corporation Finance.
Please
contact John Harrington of Baker & Hostetler LLP at (216)
861-6697 with any questions regarding the foregoing and to confirm
the effectiveness of the Registration Statement.
Very
truly yours,
Monopar
Therapeutics Inc.
By:
_/s/ Chandler D.
Robinson
Chandler D. Robinson
Chief Executive Officer
2019-11-07 - CORRESP - Monopar Therapeutics
CORRESP 1 filename1.htm Blueprint Monopar Therapeutics Inc. 1000 Skokie Blvd., Suite 350 Wilmette, Illinois 60091 November 7, 2019 VIA EDGAR US Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: Monopar Therapeutics Inc. Registration Statement on Form S-1 File No. 333-233303 Ladies and Gentlemen: In prior correspondence, dated November 5, 2019, Monopar Therapeutics Inc. (the “Company”) requested that the above-referenced Registration Statement be declared effective at 4 p.m., Eastern time, on November 7, 2019 (the “Acceleration Request”). The Acceleration Request is hereby withdrawn by the Company. Please contact John Harrington of Baker & Hostetler LLP at (216) 861-6697 with any questions regarding the foregoing. Very truly yours, Monopar Therapeutics Inc. By: /s/ Chandler D. Robinson____________ Chandler D. Robinson Chief Executive Officer
2019-11-06 - CORRESP - Monopar Therapeutics
CORRESP 1 filename1.htm Blueprint JonesTrading Institutional Services LLC Third Avenue, 23rd Floor New York, NY 10017 November 5, 2019 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Re: Monopar Therapeutics Inc. (the “Company”) Registration Statement on Form S-1 File No. 333-233303 Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), and as representative of the several underwriters of the Company’s proposed public offering, we wish to advise you that we hereby join with the Company’s request that the effective date of the above-referenced Registration Statement be accelerated so that the same will become effective at 4:00PM ET on November 7, 2019, or as soon thereafter as is practicable. Pursuant to Rule 460 under the Act, we wish to advise you that we have distributed 27 copies of the preliminary prospectus dated November 4, 2019, through the date hereof, to prospective underwriters, institutional investors, dealers and others. We, the undersigned, as representative of the several underwriters, have complied and will continue to comply, and we have been informed by the participating underwriters and dealers that they have complied and will continue to comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. Very truly yours, JonesTrading Institutional Services LLC By: /s/ Burke Cook Name: Burke Cook Title: General Counsel
2019-11-05 - CORRESP - Monopar Therapeutics
CORRESP
1
filename1.htm
Blueprint
Monopar Therapeutics Inc.
1000
Skokie Blvd., Suite 350
Wilmette,
Illinois 60091
November
5, 2019
VIA EDGAR
US
Securities and Exchange Commission
Division
of Corporation Finance
100 F
Street, NE
Washington,
DC 20549
Re:
Monopar Therapeutics Inc.
Registration Statement on Form S-1
File No. 333-233303
Ladies
and Gentlemen:
Pursuant to Rule
461 under the Securities Act of 1933, as amended, Monopar
Therapeutics Inc. (the “Company”) hereby respectfully
requests that the above-referenced Registration Statement be
declared effective at 4:00 p.m., Eastern time, on November 7, 2019
or as soon thereafter as practicable, or such later time as the
Company or its counsel may orally request via telephone call to the
staff of the Division of Corporation Finance.
Please
contact John Harrington of Baker & Hostetler LLP at (216)
861-6697 with any questions regarding the foregoing and to confirm
the effectiveness of the Registration Statement.
Very
truly yours,
Monopar
Therapeutics Inc.
By:
/s/
Chandler D.
Robinson
Chandler D.
Robinson
Chief Executive
Officer
2019-10-02 - CORRESP - Monopar Therapeutics
CORRESP 1 filename1.htm Blueprint JonesTrading Institutional Services LLC Third Avenue, 23rd Floor New York, NY 10017 October 1, 2019 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Re: Monopar Therapeutics Inc. (the “Company”) Registration Statement on Form S-1 File No. 333-233303 Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), and as representative of the several underwriters of the Company’s proposed public offering, we wish to advise you that we hereby join with the Company’s request that the effective date of the above-referenced Registration Statement be accelerated so that the same will become effective at 4:00PM ET on October 2, 2019, or as soon thereafter as is practicable. Pursuant to Rule 460 under the Act, we wish to advise you that we have distributed 78 copies of the preliminary prospectus dated September 12, 2019, through the date hereof, to prospective underwriters, institutional investors, dealers and others. We, the undersigned, as representative of the several underwriters, have complied and will continue to comply, and we have been informed by the participating underwriters and dealers that they have complied and will continue to comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. Very truly yours, JonesTrading Institutional Services LLC By: /s/ Burke Cook Name: Burke Cook Title: General Counsel
2019-10-02 - CORRESP - Monopar Therapeutics
CORRESP 1 filename1.htm Blueprint Monopar Therapeutics Inc. 1000 Skokie Blvd., Suite 350 Wilmette, Illinois 60091 October 2, 2019 VIA EDGAR US Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, DC 20549 Re: Monopar Therapeutics Inc. Registration Statement on Form S-1 File No. 333-233303 Ladies and Gentlemen: In prior correspondence, dated September 30, 2019, Monopar Therapeutics Inc. (the “Company”) requested that the above-referenced Registration Statement be declared effective at 4 p.m., Eastern time, on October 2, 2019 (the “Acceleration Request”). The Acceleration Request is hereby withdrawn by the Company. Please contact John Harrington of Baker & Hostetler LLP at (216) 861-6697 with any questions regarding the foregoing. Very truly yours, Monopar Therapeutics Inc. By: /s/ Chandler D. Robinson Name: Chandler D. Robinson Title: Chief Executive Officer
2019-09-30 - CORRESP - Monopar Therapeutics
CORRESP
1
filename1.htm
Blueprint
Monopar Therapeutics Inc.
1000
Skokie Blvd., Suite 350
Wilmette,
Illinois 60091
September
30, 2019
VIA EDGAR
US
Securities and Exchange Commission
Division
of Corporation Finance
100 F
Street, NE
Washington,
DC 20549
Re:
Monopar Therapeutics Inc.
Registration Statement on Form S-1
File No. 333-233303
Ladies
and Gentlemen:
Pursuant to Rule
461 under the Securities Act of 1933, as amended, Monopar
Therapeutics Inc. (the “Company”) hereby respectfully
requests that the above-referenced Registration Statement be
declared effective at 4 p.m., Eastern time, on October 2, 2019 or
as soon thereafter as practicable, or such later time as the
Company or its counsel may orally request via telephone call to the
staff of the Division of Corporation Finance.
Please
contact John Harrington of
Baker & Hostetler LLP at (216) 861-6697 with any
questions regarding the foregoing and to confirm the effectiveness
of the Registration Statement.
Very truly
yours,
Monopar
Therapeutics Inc.
By:
/s/
Chandler D.
Robinson
Name: Chandler D.
Robinson
Title:
Chief Executive
Officer
2019-08-26 - UPLOAD - Monopar Therapeutics
August 26, 2019
Chandler Robinson
Chief Executive Officer
Monopar Therapeutics Inc.
1000 Skokie Blvd., Suite 350
Wilmette, IL 60091
Re:Monopar Therapeutics Inc.
Registration Statement on Form S-3
Filed August 15, 2019
File No. 333-233303
Dear Dr. Robinson:
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 Sonia Bednarowski at 202-551-3666 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2018-12-13 - UPLOAD - Monopar Therapeutics
December 13, 2018
Kim R. Tsuchimoto
Chief Financial Officer
Monopar Therapeutics Inc.
1000 Skokie Blvd.
Suite 350
Wilmette, Illinois 60091
Re:Monopar Therapeutics Inc.
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed March 26, 2018 and Amended December 11, 2018
File No 000-55866
Dear Ms. Tsuchimoto:
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 Healthcare & Insurance
2018-12-11 - CORRESP - Monopar Therapeutics
CORRESP 1 filename1.htm Blueprint December 11, 2018 BY ELECTRONIC SUBMISSION United States Securities and Exchange Commission Division of Corporation Finance Office of Healthcare & Insurance Washington, DC 20549 Re: Monopar Therapeutics Inc. Form 10-K for the Fiscal Year Ended December 31, 2017, Filed March 26, 2018 File No 000-55866 Ladies and Gentlemen: Accompanying this letter for filing on behalf of Monopar Therapeutics Inc. (the “Company”) by way of electronic submission is Amendment No. 1 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, originally filed on March 26, 2018, Amendment No. 1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, originally filed on May 11, 2018, Amendment No. 1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, originally filed on August 9, 2018, and Amendment No. 1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, originally filed on November 9, 2018. The following addresses the comments of the Staff of the Commission with respect to the Annual and Quarterly Reports listed above, as conveyed in a letter dated December 3, 2018. Form 10-K for the Fiscal Year Ended December 31, 2017 Exhibits 1. The suggested revisions have been made to the Annual and Quarterly Reports listed above. Beginning with the 2018 Form 10-K, we will include certification 4(b) and include the reference to the Exchange Act definition of ICFR in the introductory language of certification 4 in all subsequent Forms 10-K and 10-Q. Please direct any questions or comments regarding the forgoing to the undersigned. Sincerely, /s/ Robert K. Rupp Robert K. Rupp
2018-12-03 - UPLOAD - Monopar Therapeutics
December 3, 2018
Kim R. Tsuchimoto
Chief Financial Officer
Monopar Therapeutics Inc.
1000 Skokie Blvd.
Suite 350
Wilmette, Illinois 60091
Re:Monopar Therapeutics Inc.
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed March 26, 2018
File No 000-55866
Dear Ms. Tsuchimoto:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment.
Please respond to this comment within 10 business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this comment, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2017
Exhibits
1.Please amend your December 31, 2017 Form 10-K and 2018 Forms 10-Q to provide the
certifications filed as Exhibits 31 exactly as presented in Item 601(b)(31) of Regulation S-
K. In this regard:
•You include certification 4(b) regarding your design of internal control over financial
reporting (ICFR) without including reference to it in the introductory language in
certification 4; and
•You fail to include certification 4(d) regarding your obligation to disclose any changes
in ICFR during the most recent quarter.
In addition, represent to us that, beginning with the 2018 Form 10-K when you provide
your assessment of ICFR, you will include certification 4(b) and include the reference to
the Exchange Act definition of ICFR in the introductory language of certification 4 in all
FirstName LastNameKim R. Tsuchimoto
Comapany NameMonopar Therapeutics Inc.
December 3, 2018 Page 2
FirstName LastName
Kim R. Tsuchimoto
Monopar Therapeutics Inc.
December 3, 2018
Page 2
subsequent Forms 10-K and 10-Q.
In closing, 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 Mark Brunhofer at (202) 551-3638 or Lisa Vanjoske at (202) 551-
3614 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2018-01-09 - UPLOAD - Monopar Therapeutics
January 8, 2018
Chandler D. Robinson
Chief Executive Officer
Monopar Therapeutics Inc.
5 Revere Drive, Suite 200
Northbrook, Illinois 60062
Monopar Therapeutics Inc.
Registration Statement on Form 10-12G
Filed November 9, 2017
File No. 000-55866Re:
Dear Dr. Robinson:
We have completed our review of your filing. 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 by the staff.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Ashley Graffeo - Baker & Hostetler, LLP
2017-12-06 - UPLOAD - Monopar Therapeutics
December 6, 2017
Chandler D. Robinson
Chief Executive Officer
Monopar Therapeutics Inc.
5 Revere Drive, Suite 200
Northbrook, Illinois 60062
Re:Monopar Therapeutics Inc.
Registration Statement on Form 10-12G
Filed November 9, 2017
File No. 000-55866
Dear Dr. Robinson:
We have reviewed your filing 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 10-12G filed November 9, 2017
Forward-Looking Statements and Industry Data
Forward-Looking Statements, page i
1.Please revise the last sentence in this section to clarify that you assume no obligation to
update any statements except as required by applicable law.
2.Please remove the reference to the safe harbor created by Section 21E of the Securities
Exchange Act of 1934 and Section 27A of the Securities Act of 1933. As you are not a
reporting company as of the date of filing you are not eligible to rely on the safe harbor
for your forward-looking statements.
FirstName LastNameChandler D. Robinson
Comapany NameMonopar Therapeutics Inc.
June 16, 2017 Page 2
FirstName LastNameChandler D. Robinson
Monopar Therapeutics Inc.
December 6, 2017
Page 2
Industry, page ii
3.You state that you have not "independently verified" information in internal analyses,
market research, outside consultant reports, and industry publications and make "no
representation as to the accuracy of this information." In addition, you state that all
references in the registration statement to internal analyses, market research, outside
consultant reports, industry publications, and other documents are qualified in their
entirety by reference to the full text of those documents. Under the federal securities
laws, you are responsible for all information contained within your registration
statement. As such, these types of disclaimers are not appropriate. Please revise
accordingly.
Item 1. Business, page 1
4.Please revise to spell out and/or define the following terms in plain language so that it
may be understood by lay readers not acquainted with the relevant industry or scientific
field:
•RT induced SOM;
•redox cycling;
•leiomyosarcoma; and
•uPA system.
Our Drug Product Candidates, page 4
5.Please disclose all investigational new drug applications ("INDs") that have been
submitted to the FDA for each applicable product candidate. For any active INDs related
to your product candidates, please also disclose when each IND was submitted, the
sponsor(s) of the IND and the specific indications listed therein. If you believe that no
INDs are required for any of these products and/or indications at this time, please explain
why in your disclosure.
Validive® (clonidine mucobuccal tablet; clonidine MBT)
Clinical Data, page 6
6.At first use, please provide a brief explanation of the disclosed p-value and how it is used
to measure statistical significance. Please also explain the relevance of statistical
significance to the FDA's evidentiary standards for drug approval.
GPX-150 (5-imino 13-deoxydoxorubicin)
Clinical Data, page 8
7.We note your statements that several clinical studies "support the safety and efficacy of
GPX-150 have been completed," and that GPX-150 had "similar anticancer efficacy as
doxorubicin in soft tissue sarcoma" and a "superior safety profile to that observed with
FirstName LastNameChandler D. Robinson
Comapany NameMonopar Therapeutics Inc.
June 16, 2017 Page 3
FirstName LastNameChandler D. Robinson
Monopar Therapeutics Inc.
December 6, 2017
Page 3
doxorubicin." Please revise your disclosure to eliminate any suggestion that your product
candidate has been or will ultimately be determined to be safe or effective or to have
demonstrated efficacy for purposes of receiving marketing approval by the FDA or
comparable agency, including comparisons to the current standard of care.
MNPR-101 (huATN-658)
Combination Use, page 10
8.We note your statement that MNPR-101 has "enhanced the activity of multiple widely
used chemotherapies in preclinical testing." Please expand your disclosure to provide
data or a basis for this statement.
Material Agreements, page 11
9.Please revise your disclosure to include the option fee required to license the MNPR-101
data from Cancer Research UK after completion of the Phase Ib clinical trial.
10.Please revise your description of your agreement with Onxeo S.A. to provide the
following information:
•aggregate milestones payable;
•royalty rate (or royalty range not to exceed a ten percent range);
•duration of the agreement and royalty term; and
•termination provisions.
Intellectual Property Portfolio, page 12
11.Please expand your description of your patent portfolios for MNPR-101 and Validive to
disclose the type of patent protection you have (such as composition of matter, use or
process, etc.). In addition, please revise to disclose whether you license or own your
patents and patent applications relating to MNPR-101. Please also specify the expiration
dates for of the most significant patents within each patent portfolio.
Management's Discussion and Analysis
Critical Accounting Policies and Use of Estimates
Stock-Based Compensation, page 53
12.You state on page 54 "The fair market value of the 273,000 options granted in April
2016, the 7,000 options granted in December 2016 and the 275,520 options granted in
February 2017 was nominal at the time of grant..." Please revise the disclosure to explain
how you determined the $198,090 of stock compensation in the six months ended June
30, 2017 or the amount you recognize for the nine months ended September 30, 2017.
FirstName LastNameChandler D. Robinson
Comapany NameMonopar Therapeutics Inc.
June 16, 2017 Page 4
FirstName LastName
Chandler D. Robinson
Monopar Therapeutics Inc.
December 6, 2017
Page 4
Liquidity and Capital Resources
Contractual Obligations and Commitments, page 65
13.In order for an investor to understand the magnitude of your commitment, please quantify
the amount of milestones and royalties you may be obligated to pay under your
development and collaboration agreements.
Item 4. Security Ownership of Certain Beneficial Owners and Management, page 70
14.Please disclose the natural person or persons who have ultimate voting or investment
control over the shares held by TacticGem LLC, Tactic Pharma LLC and Gem
Pharmaceutical LLC. Refer to Instruction 2 to Item 403 of Regulation S-K.
General
15.Please note that pursuant to Exchange Act Section 12(g)(1), this registration statement
on Form 10 becomes effective automatically 60 days after its initial filing. You will then
be subject to the reporting requirements of the Exchange Act of 1934, including
the requirements to file Forms 10-K, 10-Q, and 8-K even if comments remain open on
the Form 10. If you do not wish to become subject to these reporting requirements
before completion of our review, you may wish to consider withdrawing the Form 10
before it becomes effective automatically and submitting a new Form 10 that includes
changes responsive to our comments. Please note that we will continue to review your
filing until all of our comments have been addressed.
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 Mark Brunhofer at 202-551-3638 or Lisa Vanjoske at 202-551-3614 if
you have questions regarding comments on the financial statements and related matters. Please
contact Irene Paik at 202-551-6553 or Christopher Edwards at 202-551-6761 with any other
questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Ashley Graffeo - Baker &Hostetler, LLP