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Moleculin Biotech, Inc.
Response Received
1 company response(s)
High - file number match
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Moleculin Biotech, Inc.
Response Received
1 company response(s)
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Moleculin Biotech, Inc.
Response Received
6 company response(s)
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Moleculin Biotech, Inc.
Awaiting Response
0 company response(s)
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Moleculin Biotech, Inc.
Response Received
1 company response(s)
High - file number match
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Moleculin Biotech, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2024-07-26
Moleculin Biotech, Inc.
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Company responded
2024-08-15
Moleculin Biotech, Inc.
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2024-08-15
Moleculin Biotech, Inc.
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Moleculin Biotech, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-06-13
Moleculin Biotech, Inc.
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Company responded
2024-06-27
Moleculin Biotech, Inc.
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Moleculin Biotech, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-02-09
Moleculin Biotech, Inc.
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2024-02-09
Moleculin Biotech, Inc.
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Moleculin Biotech, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-06-04
Moleculin Biotech, Inc.
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2021-06-09
Moleculin Biotech, Inc.
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Moleculin Biotech, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2020-01-06
Moleculin Biotech, Inc.
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2020-01-07
Moleculin Biotech, Inc.
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2020-04-07
Moleculin Biotech, Inc.
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Moleculin Biotech, Inc.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2018-10-23
Moleculin Biotech, Inc.
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2018-10-24
Moleculin Biotech, Inc.
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2018-10-25
Moleculin Biotech, Inc.
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2018-10-25
Moleculin Biotech, Inc.
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Moleculin Biotech, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2018-07-19
Moleculin Biotech, Inc.
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2018-07-19
Moleculin Biotech, Inc.
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Moleculin Biotech, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2018-05-23
Moleculin Biotech, Inc.
Summary
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Moleculin Biotech, Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2017-08-01
Moleculin Biotech, Inc.
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2017-08-11
Moleculin Biotech, Inc.
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2017-08-18
Moleculin Biotech, Inc.
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Moleculin Biotech, Inc.
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2016-12-19
Moleculin Biotech, Inc.
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2017-01-18
Moleculin Biotech, Inc.
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2017-02-08
Moleculin Biotech, Inc.
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2017-02-08
Moleculin Biotech, Inc.
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2017-02-08
Moleculin Biotech, Inc.
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Moleculin Biotech, Inc.
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2016-03-04
Moleculin Biotech, Inc.
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2016-03-21
Moleculin Biotech, Inc.
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2016-04-15
Moleculin Biotech, Inc.
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2016-04-28
Moleculin Biotech, Inc.
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2016-04-28
Moleculin Biotech, Inc.
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Moleculin Biotech, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2016-04-13
Moleculin Biotech, Inc.
Summary
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Moleculin Biotech, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2016-01-04
Moleculin Biotech, Inc.
Summary
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Company responded
2016-02-01
Moleculin Biotech, Inc.
References: December 31, 2015
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-02 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | 333-292420 | Read Filing View |
| 2026-01-02 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2025-09-29 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2025-09-24 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | 333-290418 | Read Filing View |
| 2025-06-17 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2025-06-17 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2025-06-16 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2025-06-13 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | 377-08038 | Read Filing View |
| 2025-06-11 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2025-06-10 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | 377-08038 | Read Filing View |
| 2025-06-03 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2025-06-03 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2025-04-04 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | 333-286276 | Read Filing View |
| 2025-04-04 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2024-08-15 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2024-08-15 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2024-07-26 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | 333-280951 | Read Filing View |
| 2024-06-27 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2024-06-13 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | 333-280064 | Read Filing View |
| 2024-02-09 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2024-02-09 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | 333-276851 | Read Filing View |
| 2021-06-09 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2021-06-04 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2020-04-07 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2020-01-07 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2020-01-06 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2018-10-25 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2018-10-25 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2018-10-24 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2018-10-23 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2018-07-19 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2018-07-19 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2018-05-23 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2017-08-18 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2017-08-11 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2017-08-01 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2017-02-08 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2017-02-08 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2017-02-08 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2017-01-18 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2016-12-19 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2016-04-28 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2016-04-28 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2016-04-15 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2016-04-13 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2016-03-21 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2016-03-04 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2016-02-01 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2016-01-04 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-02 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | 333-292420 | Read Filing View |
| 2025-09-24 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | 333-290418 | Read Filing View |
| 2025-06-13 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | 377-08038 | Read Filing View |
| 2025-06-10 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | 377-08038 | Read Filing View |
| 2025-04-04 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | 333-286276 | Read Filing View |
| 2024-07-26 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | 333-280951 | Read Filing View |
| 2024-06-13 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | 333-280064 | Read Filing View |
| 2024-02-09 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | 333-276851 | Read Filing View |
| 2021-06-04 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2020-01-06 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2018-10-23 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2018-07-19 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2017-08-01 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2016-12-19 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2016-04-13 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2016-03-04 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2016-01-04 | SEC Comment Letter | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-02 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2025-09-29 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2025-06-17 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2025-06-17 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2025-06-16 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2025-06-11 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2025-06-03 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2025-06-03 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2025-04-04 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2024-08-15 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2024-08-15 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2024-06-27 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2024-02-09 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2021-06-09 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2020-04-07 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2020-01-07 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2018-10-25 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2018-10-25 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2018-10-24 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2018-07-19 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2018-05-23 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2017-08-18 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2017-08-11 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2017-02-08 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2017-02-08 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2017-02-08 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2017-01-18 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2016-04-28 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2016-04-28 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2016-04-15 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2016-03-21 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
| 2016-02-01 | Company Response | Moleculin Biotech, Inc. | DE | N/A | Read Filing View |
2026-01-02 - UPLOAD - Moleculin Biotech, Inc. File: 333-292420
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> January 2, 2026 Walter V. Klemp Chief Executive Officer Moleculin Biotech, Inc. 5300 Memorial Drive, Suite 950 Houston, TX 77007 Re: Moleculin Biotech, Inc. Registration Statement on Form S-3 Filed December 23, 2025 File No. 333-292420 Dear Walter V. Klemp: 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 Chris Edwards at 202-551-6761 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Cavas S. Pavri </TEXT> </DOCUMENT>
2026-01-02 - CORRESP - Moleculin Biotech, Inc.
CORRESP 1 filename1.htm mbrx20260102_corresp.htm Moleculin Biotech, Inc. 5300 Memorial Drive, Suite 950 Houston, TX 77007 January 2, 2026 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Attention: Jessica Dickerson Re: Moleculin Biotech, Inc. Registration Statement on Form S-1 Registration No. 333-292420 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 4:00 P.M. (Eastern Time) on January 6, 2026, or as soon thereafter as possible on such date. Very truly yours, Moleculin Biotech, Inc. By: /s/ Jonathan P. Foster Name: Jonathan P. Foster Title: Chief Financial Officer
2025-09-29 - CORRESP - Moleculin Biotech, Inc.
CORRESP 1 filename1.htm mbrx20250929_corresp.htm Moleculin Biotech, Inc. 5300 Memorial Drive, Suite 950 Houston, TX 77007 September 29, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Attention: Jessica Dickerson Re: Moleculin Biotech, Inc. Registration Statement on Form S-3 Registration No. 333-290418 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 4:30 P.M. (Eastern Time) on September 30, 2025, or as soon thereafter as possible on such date. Very truly yours, Moleculin Biotech, Inc. By: /s/ Jonathan P. Foster Name: Jonathan P. Foster Title: Chief Financial Officer
2025-09-24 - UPLOAD - Moleculin Biotech, Inc. File: 333-290418
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 24, 2025 Walter Klemp Chief Executive Officer Moleculin Biotech, Inc. 5300 Memorial Drive, Suite 950 Houston, TX 77007 Re: Moleculin Biotech, Inc. Registration Statement on Form S-3 Filed September 19, 2025 File No. 333-290418 Dear Walter Klemp: 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 Jessica Dickerson at 202-551-8013 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Cavas S. Pavri, Esq. </TEXT> </DOCUMENT>
2025-06-17 - CORRESP - Moleculin Biotech, Inc.
CORRESP 1 filename1.htm mbrx20250617c_corresp.htm Roth Capital Partners, LLC 888 San Clemente Drive Newport Beach, CA 92660 June 17, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Washington, DC 20549 Re: Moleculin Biotech, Inc. Registration Statement on Form S-1 (Registration No. 333-287727) Concurrence in Acceleration Request Ladies and Gentlemen: Roth Capital Partners, LLC (“ Roth ”), as placement agent for the referenced offering, hereby concurs in the request by Moleculin Biotech, Inc. that the effective date of the above-referenced registration statement be accelerated to 9:00 a.m. (Eastern Time), or as soon as practicable thereafter, on Wednesday, June 18, 2025, pursuant to Rule 461 under the Securities Act. Roth affirms that it is aware of its obligations under the Securities Act in connection with this offering. [ Signature Page Follows ] Very truly yours, ROTH CAPITAL PARTNERS, LLC By: /s/ Louis J. Ellis Name: Louis J. Ellis Title: Managing Director, Equity Capital Markets
2025-06-17 - CORRESP - Moleculin Biotech, Inc.
CORRESP 1 filename1.htm mbrx20250617_corresp.htm Moleculin Biotech, Inc. 5300 Memorial Drive, Suite 950 Houston, TX 77007 June 17, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Attention: Daniel Crawford Re: Moleculin Biotech, Inc. Registration Statement on Form S-1 Registration No. 333-287727 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 9:00 A.M. (Eastern Time) on June 18, 2025, or as soon thereafter as possible on such date. Very truly yours, Moleculin Biotech, Inc. By: /s/ Jonathan P. Foster Name: Jonathan P. Foster Title: Chief Financial Officer
2025-06-16 - CORRESP - Moleculin Biotech, Inc.
CORRESP 1 filename1.htm mbrx20250616_corresp.htm June 16, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Industrial Applications and Services 100 F Street, NE Washington, DC 20549 Attention: Daniel Crawford Re: Moleculin Biotech, Inc. Amendment No. 2 to Registration Statement on Form S-1 Filed June 11, 2025 File No. 333-287727 Ladies and Gentlemen: This letter is being submitted on behalf of Moleculin Biotech, Inc. (the “ Company ”) in response to the comment letter, dated June 13, 2025, of the staff of the Division of Corporation Finance (the “ Staff ”) of the Securities and Exchange Commission (the “ Commission ”) with respect to the Amendment No. 2 to Registration Statement on Form S-1 filed on June 11, 2025 (the “ Registration Statement ”). The Company’s amended Registration Statement (the “ Amended Registration Statement ”) has been filed with the Commission. Amendment No. 2 to Registration Statement on Form S- 1 Risk Factors Related to this Offering, page 6 1. We note your revised risk factor disclosure on page 8 regarding an existing stockholders' equity continued listing deficiency. In light of your current stock price, the dilution from this offering, and the floor price for the Series E warrant reset, please add a risk factor addressing the potential for a continued listing deficiency related to your bid price. To the extent that a reverse stock split would likely be required to address a bid price deficiency, please address risks related to conducting a reverse split. Without limitation, please explain, if true, that a reverse stock split would trigger a reset to the Series E warrants potentially resulting in a significant decrease to the exercise price of the warrants and significant increase to the number of common shares underlying the Series E warrants. RESPONSE: The “Risk Factors” section in the Amended Registration Statement has been amended to include the following new disclosure: “Our ability to maintain compliance with Nasdaq ’ s bid price requirements may be hindered by the completion of this offering and the future exercises of the Series E warrants. Our common stock is listed on Nasdaq, and we are therefore subject to its continued listing requirements, including requirements with respect to the maintenance of a minimum bid price of $1.00 per share. Since May 13, 2025, our common stock has not had a closing bid price of over $1.00 share. If the closing bid price of our common stock does not exceed $1.00 within 30 trading days of May 13, 2025, we will not be in compliance with Nasdaq’s continued listing requirements. The completion of this offering may further decrease our common stock price, and the future exercise of the Series E warrants may also depress our common stock price. In addition, if the exercise price adjustment provisions of the Series E warrants are triggered in the future, which would cause a reduction in the exercise price of the Series E warrants (subject to the floor price) and a proportionate increase in the number of shares underling the Series E warrants, such event may further depress our common stock price. United States Securities and Exchange Commission June 16, 2025 Page 2 In order to increase our common stock price and address any future Nasdaq bid price deficiency, we may in the future complete a reverse stock split. If we complete a reverse stock split and the lowest daily volume weighted average price during the period commencing five consecutive trading days immediately preceding and the five consecutive trading days commencing on the date of such split is less than the exercise price of the Series E warrants then in effect, then the exercise price of the Series E warrants will be reduced to the lowest daily volume weighted average price during such period and, following the Authorized Share Increase Date, the number of shares issuable upon exercise will be proportionately adjusted such that the aggregate price will remain unchanged, subject to the floor price. This future potential adjustment of the Series E warrants may significantly increase the number of shares of common stock underlying the Series E warrants and cause dilution to our shareholders.” 2. Please revise to discuss, as applicable, risks related to Nasdaq's potential use of its discretionary authority under Listing Rule 5101 to delist a company's securities based on public interest concerns raised by the issuance of warrants with features that could result in substantial dilution to shareholders. RESPONSE: The “Risk Factors” section in the Amended Registration Statement has been amended to include the following new disclosure: “Nasdaq may delist our common stock for public interest concerns as a result of this offering. Because of the dilutive nature of this offering, Nasdaq may delist our common stock for public interest concerns. A number of Nasdaq-listed companies have filed public disclosures regarding the receipt of notification letters indicating that Nasdaq made the determination to delist such companies as a result of public interest concerns arising from the issuance of warrants with certain dilutive terms. While we believe that the Series E warrants being offered hereby are materially different than the warrants offered by those companies, there can be no assurance that Nasdaq will agree and our common stock may be delisted from Nasdaq as a result.” Duration and Exercise Price, page 17 3. We note your revised disclosure in response to prior comment 2. Please revise to clarify, if true, that the 160,714,286 figure is the maximum number of common shares underlying the warrants regardless of how many times the reset provision is triggered in the future. RESPONSE: The table in the subsection “Duration and Exercise Price” in the Amended Registration Statement has been revised to include the following footnote disclosure: “(1) Represents the maximum number of shares of common stock underlying the Series E warrants regardless of how many times the exercise price adjustment provision is triggered in the future.” United States Securities and Exchange Commission June 16, 2025 Page 3 * * * * * * Should you have any questions regarding the foregoing, please do not hesitate to contact Cavas Pavri at (202) 724-6847. Sincerely, ARENTFOX SCHIFF LLP /s/ Cavas Pavri By: Cavas Pavri Enclosures cc: Walter Klemp, CEO, Moleculin Biotech, Inc. Jonathan P. Foster, CFO, Moleculin Biotech, Inc.
2025-06-13 - UPLOAD - Moleculin Biotech, Inc. File: 377-08038
June 13, 2025
Walter V. Klemp
President, Chief Executive Officer and Chairman
Moleculin Biotech, Inc.
5300 Memorial Drive, Suite 950
Houston, TX 77007
Re:Moleculin Biotech, Inc.
Amendment No. 2 to Registration Statement on Form S-1
Filed June 11, 2025
File No. 333-287727
Dear Walter V. Klemp:
We have reviewed your amended registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information
you provide in response to this letter, we may have additional comments. Unless we note
otherwise, any references to prior comments are to comments in our June 10, 2025 letter.
Amendment No. 2 to Registration Statement on Form S-1
Risk Factors Related to this Offering, page 6
1.We note your revised risk factor disclosure on page 8 regarding an existing
stockholders' equity continued listing deficiency. In light of your current stock price,
the dilution from this offering, and the floor price for the Series E warrant reset,
please add a risk factor addressing the potential for a continued listing deficiency
related to your bid price. To the extent that a reverse stock split would likely be
required to address a bid price deficiency, please address risks related to conducting a
reverse split. Without limitation, please explain, if true, that a reverse stock split
would trigger a reset to the Series E warrants potentially resulting in a significant
decrease to the exercise price of the warrants and significant increase to the number of
common shares underlying the Series E warrants.
June 13, 2025
Page 2
2.Please revise to discuss, as applicable, risks related to Nasdaq's potential use of
its discretionary authority under Listing Rule 5101 to delist a company's securities
based on public interest concerns raised by the issuance of warrants with features that
could result in substantial dilution to shareholders.
Duration and Exercise Price, page 17
3.We note your revised disclosure in response to prior comment 2. Please revise to
clarify, if true, that the 160,714,286 figure is the maximum number of common shares
underlying the warrants regardless of how many times the reset provision is triggered
in the future.
Please contact Daniel Crawford at 202-551-7767 or Joe McCann at 202-551-6262
with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Cavas Pavri, Esq.
2025-06-11 - CORRESP - Moleculin Biotech, Inc.
CORRESP 1 filename1.htm mbrx20250611_corresp.htm June 11, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Industrial Applications and Services 100 F Street, NE Washington, DC 20549 Attention: Daniel Crawford Re: Moleculin Biotech, Inc. Amendment No. 1 to Registration Statement on Form S-1 Filed June 6, 2025 File No. 333-287727 Ladies and Gentlemen: This letter is being submitted on behalf of Moleculin Biotech, Inc. (the “ Company ”) in response to the comment letter, dated June 10, 2025, of the staff of the Division of Corporation Finance (the “ Staff ”) of the Securities and Exchange Commission (the “ Commission ”) with respect to the Amendment No. 1 to Registration Statement on Form S-1 filed on June 6, 2025 (the “ Registration Statement ”). The Company’s amended Registration Statement (the “ Amended Registration Statement ”) has been filed with the Commission. Amendment No. 1 to Registration Statement on Form S- 1 Risk Factors Risks Related to this Offering Your ownership may be diluted if additional capital stock is issued to raise capital . . . , page 7 1. We note your disclosure on page 6 that you will require additional capital funding and on page 8 that you believe the net proceeds from this offering will satisfy your capital needs into the third or fourth quarter of 2025. Please revise to add risk factor disclosure regarding the risk that future issuances of your capital stock in the near term may result in triggering the reset provision in your Series E Warrants and increase the number of shares of common stock underlying each warrant. RESPONSE: The “Risk Factors” section in the Amended Registration Statement has been amended to include the following new disclosure: “We will require additional financing in the near term, which financing may result in the reduction of the exercise price of the Series E warrants and the increase in the number of shares underlying the Series E warrants, which would dilute the ownership interest of our shareholders. As described in the risk factor “We will require substantial additional funding, which may not be available to us on acceptable terms, or at all, and, if not so available, may require us to delay, limit, reduce or cease our operations.” set forth above, we will require additional financing in the near term. United States Securities and Exchange Commission June 11, 2025 Page 2 The Series E warrants provide that if, while the Series E warrants are outstanding, we sell any common stock and/or common stock equivalents other than in connection with certain exempt issuances, at a purchase price per share less than the exercise price of the Series E warrants in effect immediately prior to such sale, then immediately after such sale the exercise price of the Series E warrants then in effect will be reduced to an amount equal to the new issuance price, and, following the date that we amend our certificate of incorporation to increase our authorized shares of common stock, the number of shares issuable upon exercise of the Series E warrants will be proportionately adjusted such that the aggregate price will remain unchanged, subject to the floor price. The floor price will not be less than 20% of the lower of: (i) the closing price of our common stock immediately preceding the offering; or (ii) the average closing price for the five trading days immediately preceding the offering. Assuming a floor price of approximately $0.14 based on an assumed closing price of $0.69 per share, which was the closing price of our common stock as reported on Nasdaq on June 5, 2025, the total number of shares potentially issuable under the Series E warrants if the exercise price of the Series E warrants was reduced to the floor price would be 160,714,286 shares of common stock. As described above, if the exercise price of the Series E warrants decreases, the number of shares underlying the Series E warrants will increase substantially, which would materially dilute the ownership of our shareholders. In addition, after the completion of this offering, the Series E warrant holders are not prohibited from effecting “short sales” of our common stock, which may depress the price of our common stock.” Description of Common Warrants Series E Warrant Duration and Exercise Price, page 17 2. We note your disclosure on page 17 that a future offering conducted at a purchase price per share less than the exercise price of the Series E warrants would result in an adjustment to the number of shares underlying each Series E warrant. Please revise this section to explain the reset provisions by providing examples illustrating the impact to the number of shares underlying the warrants under various pricing scenarios. Revise here and on the cover page to highlight the maximum number of shares issuable upon exercise of the warrants assuming a reset at the floor price. Also, revise your Risk Factor section to reflect the risks of dilution and, to the extent not prohibited, short-selling activity by Series E warrant holders. RESPONSE: The Amended Registration Statement has been revised to include a table illustrating the impact to the number of shares underlying the Series E warrants under various pricing scenarios. The cover page has been amended to highlight the maximum number of shares issuable upon exercise of the Series E warrants assuming a reset at the floor price. The new risk factor included in the Amended Registration Statement in response to the Staff’s comment #1 reflect the risks of dilution and, to the extent not prohibited, short-selling activity by Series E warrant holders. * * * * * * United States Securities and Exchange Commission June 11, 2025 Page 3 Should you have any questions regarding the foregoing, please do not hesitate to contact Cavas Pavri at (202) 724-6847. Sincerely, ARENTFOX SCHIFF LLP /s/ Cavas Pavri By: Cavas Pavri Enclosures cc: Walter Klemp, CEO, Moleculin Biotech, Inc. Jonathan P. Foster, CFO, Moleculin Biotech, Inc.
2025-06-10 - UPLOAD - Moleculin Biotech, Inc. File: 377-08038
June 10, 2025
Walter V. Klemp
President, Chief Executive Officer and Chairman
Moleculin Biotech, Inc.
5300 Memorial Drive, Suite 950
Houston, TX 77007
Re:Moleculin Biotech, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed June 6, 2025
File No. 333-287727
Dear Walter V. Klemp:
We have reviewed your amended registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information
you provide in response to this letter, we may have additional comments.
Amendment No. 1 to Registration Statement on Form S-1
Risk Factors
Risks Related to this Offering
Your ownership may be diluted if additional capital stock is issued to raise capital . . . , page
7
1.We note your disclosure on page 6 that you will require additional capital funding and
on page 8 that you believe the net proceeds from this offering will satisfy your capital
needs into the third or fourth quarter of 2025. Please revise to add risk
factor disclosure regarding the risk that future issuances of your capital stock in the
near term may result in triggering the reset provision in your Series E Warrants and
increase the number of shares of common stock underlying each warrant.
June 10, 2025
Page 2
Description of Common Warrants
Series E Warrant
Duration and Exercise Price, page 17
2.We note your disclosure on page 17 that a future offering conducted at a purchase
price per share less than the exercise price of the Series E warrants would result in an
adjustment to the number of shares underlying each Series E warrant. Please revise
this section to explain the reset provisions by providing examples illustrating the
impact to the number of shares underlying the warrants under various pricing
scenarios. Revise here and on the coverpage to highlight the maximum number of
shares issuable upon exercise of the warrants assuming a reset at the floor price. Also,
revise your Risk Factor section to reflect the risks of dilution and, to the extent not
prohibited, short-selling activity by Series E warrant holders.
Please contact Daniel Crawford at 202-551-7767 or Joe McCann at 202-551-6262
with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Cavas Pavri, Esq.
2025-06-03 - CORRESP - Moleculin Biotech, Inc.
CORRESP 1 filename1.htm mbrx20250603c_corresp.htm Roth Capital Partners, LLC 888 San Clemente Drive Newport Beach, CA 92660 June 3, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Washington, DC 20549 Re: Moleculin Biotech, Inc. Registration Statement on Form S-1 (Registration No. 333-287727) Concurrence in Acceleration Request Ladies and Gentlemen: Roth Capital Partners, LLC (“ Roth ”), as placement agent for the referenced offering, hereby concurs in the request by Moleculin Biotech, Inc. that the effective date of the above-referenced registration statement be accelerated to 5:00 p.m. (Eastern Time), or as soon as practicable thereafter, on Wednesday, June 4, 2025, pursuant to Rule 461 under the Securities Act. Roth affirms that it is aware of its obligations under the Securities Act in connection with this offering. [ Signature Page Follows ] Very truly yours, ROTH CAPITAL PARTNERS, LLC By: /s/ Louis J. Ellis Name: Louis J. Ellis Title: Managing Director, Equity Capital Markets
2025-06-03 - CORRESP - Moleculin Biotech, Inc.
CORRESP 1 filename1.htm mbrx20250603_corresp.htm Moleculin Biotech, Inc. 5300 Memorial Drive, Suite 950 Houston, TX 77007 June 3, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Attention: Daniel Crawford Re: Moleculin Biotech, Inc. Registration Statement on Form S-1 Registration No. 333-287727 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 5:00 P.M. (Eastern Time) on June 4, 2025, or as soon thereafter as possible on such date. Very truly yours, Moleculin Biotech, Inc. By: /s/ Jonathan P. Foster Name: Jonathan P. Foster Title: Chief Financial Officer
2025-04-04 - UPLOAD - Moleculin Biotech, Inc. File: 333-286276
April 4, 2025
Walter Klemp
Chief Executive Officer
Moleculin Biotech, Inc.
5300 Memorial Drive, Suite 950
Houston, TX 77007
Re:Moleculin Biotech, Inc.
Registration Statement on Form S-1
Filed March 31, 2025
File No. 333-286276
Dear Walter Klemp:
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:Cavas S. Pavri
2025-04-04 - CORRESP - Moleculin Biotech, Inc.
CORRESP 1 filename1.htm mbrx20250404_corresp.htm Moleculin Biotech, Inc. 5300 Memorial Drive, Suite 950 Houston, TX 77007 April 4, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Attention: Alan Campbell Re: Moleculin Biotech, Inc. Registration Statement on Form S-1 Registration No. 333-286276 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 4:00 P.M. (Eastern Time) on April 7, 2025, or as soon thereafter as possible on such date. Very truly yours, Moleculin Biotech, Inc. By: /s/ Jonathan P. Foster Name: Jonathan P. Foster Title: Chief Financial Officer
2024-08-15 - CORRESP - Moleculin Biotech, Inc.
CORRESP 1 filename1.htm mbrx20240815c_corresp.htm August 15, 2024 VIA FACSIMILE AND EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Re: Moleculin Biotech, Inc. Registration Statement on Form S-1 (Registration No. 333-280951) - Concurrence in Acceleration Request Ladies and Gentlemen: H.C. Wainwright & Co., LLC (“Wainwright”), solely acting as placement agent on a best-efforts basis in an offering pursuant to the registration statement on Form S-1 (333-280951) (the “Registration Statement”), hereby concurs in the request by Moleculin Biotech, Inc. that the effective date of the above-referenced registration statement be accelerated to 5:15 P.M. Eastern Time on Thursday, August 15, 2024, or as soon as practicable thereafter, pursuant to Rule 461 under the Securities Act. Wainwright affirms that it is aware of its obligations under the Securities Act as they pertain to the best efforts offering pursuant to the Registration Statement. Very truly yours, H.C. WAINWRIGHT & CO., LLC By: /s/ Edward D. Silvera Name: Edward D. Silvera Title: Chief Operating Officer
2024-08-15 - CORRESP - Moleculin Biotech, Inc.
CORRESP 1 filename1.htm mbrx20240815_corresp.htm Moleculin Biotech, Inc. 5300 Memorial Drive, Suite 950 Houston, TX 77007 August 15, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Attention: Jessica Dickerson Re: Moleculin Biotech, Inc. Registration Statement on Form S-1 Registration No. 333-280951 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 5:15 P.M. (Eastern Time) on August 15, 2024, or as soon thereafter as possible on such date. Very truly yours, Moleculin Biotech, Inc. By: /s/ Jonathan P. Foster Name: Jonathan P. Foster Title: Chief Financial Officer
2024-07-26 - UPLOAD - Moleculin Biotech, Inc. File: 333-280951
July 25, 2024
Jonathan Foster
Chief Financial Officer
Moleculin Biotech, Inc.
5300 Memorial Drive, Suite 950
Houston, TX 7707
Re:Moleculin Biotech, Inc.
Registration Statement on Form S-1
Filed July 22, 2024
File No. 333-280951
Dear Jonathan Foster:
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 Jessica Dickerson at 202-551-8013 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Cavas S. Pavri, Esq.
2024-06-27 - CORRESP - Moleculin Biotech, Inc.
CORRESP 1 filename1.htm mbrx20240627_corresp.htm Moleculin Biotech, Inc. 5300 Memorial Drive, Suite 950 Houston, TX 77007 June 27, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Attention: Chris Edwards Re: Moleculin Biotech, Inc. Registration Statement on Form S-3 Registration No. 333-280064 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 4:00 P.M. (Eastern Time) on July 1, 2024, or as soon thereafter as possible on such date. Very truly yours, Moleculin Biotech, Inc. By: /s/ Jonathan P. Foster Name: Jonathan P. Foster Title: Chief Financial Officer
2024-06-13 - UPLOAD - Moleculin Biotech, Inc. File: 333-280064
United States securities and exchange commission logo
June 12, 2024
Walter V. Klemp
Chief Executive Officer
Moleculin Biotech, Inc.
5300 Memorial Drive, Suite 950
Houston, TX 77007
Re:Moleculin Biotech, Inc.
Registration Statement on Form S-3
Filed June 7, 2024
File No. 333-280064
Dear Walter V. Klemp:
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 Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Cavas S. Pavri
2024-02-09 - CORRESP - Moleculin Biotech, Inc.
CORRESP 1 filename1.htm mbrx20240209_corresp.htm February 9, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Attention: Chris Edwards Re: Moleculin Biotech, Inc. Registration Statement on Form S-1 Registration No. 333-276851 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 4:30 P.M. (Eastern Time) on February 12, 2024, or as soon thereafter as possible on such date. Very truly yours, Moleculin Biotech, Inc. By: /s/ Jonathan Foster Name: Jonathan Foster Title: Chief Financial Officer
2024-02-09 - UPLOAD - Moleculin Biotech, Inc. File: 333-276851
United States securities and exchange commission logo
February 9, 2024
Walter V. Klemp
Chief Executive Officer and Chairman
Moleculin Biotech, Inc.
5300 Memorial Drive, Suite 950
Houston, Texas 77007
Re:Moleculin Biotech, Inc.
Registration Statement on Form S-1
Filed February 2, 2024
File No. 333-276851
Dear Walter V. Klemp:
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 Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Cavas S. Pavri
2021-06-09 - CORRESP - Moleculin Biotech, Inc.
CORRESP 1 filename1.htm mbrx20210609_corresp.htm June 9, 2021 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Attention: Ada D. Sarmento Re: Moleculin Biotech, Inc. Registration Statement on Form S-3 Registration No. 333-256627 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 4:30 P.M. (Eastern Time) on June 11, 2021, or as soon thereafter as possible on such date. Very truly yours, Moleculin Biotech, Inc. By: /s/ Jonathan Foster Name: Jonathan Foster Title: Chief Financial Officer
2021-06-04 - UPLOAD - Moleculin Biotech, Inc.
United States securities and exchange commission logo
June 4, 2021
Walter V. Klemp
Chief Executive Officer
Moleculin Biotech, Inc.
5300 Memorial Drive, Suite 950
Houston, TX 77007
Re:Moleculin Biotech, Inc.
Registration Statement on Form S-3
Filed May 28, 2021
File No. 333-256627
Dear Mr. Klemp:
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 Ada D. Sarmento at 202-551-3798 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Cavas S. Pavri, Esq.
2020-04-07 - CORRESP - Moleculin Biotech, Inc.
CORRESP 1 filename1.htm Document April 7, 2020 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Re: Moleculin Biotech, Inc. Registration Statement on Form S-3 Registration No. 333-235686 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 4:30 P.M. (Eastern Time) on April 9, 2020, or as soon thereafter as possible on such date. Very truly yours, Moleculin Biotech, Inc. By: /s/ Jonathan P. Foster Name: Jonathan P. Foster Title: Chief Financial Officer DC\82195168.1
2020-01-07 - CORRESP - Moleculin Biotech, Inc.
CORRESP 1 filename1.htm Document 100 N. 18th Street Suite 300 Philadelphia, PA 19103 t 202.778.6400 f 202.778.6460 www.schiffhardin.com Cavas S. Pavri 202.724.6847 cpavri@schiffhardin.com January 7, 2020 BY EDGAR SUBMISSION Securities and Exchange Commission Division of Corporation Finance Office of Healthcare & Insurance 100 F Street, N.E. Washington, D.C. 20549 Attention: Tim Buchmiller Re: Moleculin Biotech, Inc. Registration Statement on Form S-3 Filed December 23, 2019 File No. 333-235686 Dear Mr. Buchmiller: This letter is being submitted on behalf of Moleculin Biotech, Inc. (“Company”) in response to the comment letter, dated January 6, 2020, of the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) with respect to the Company’s Registration Statement on Form S-3 filed December 23, 2019 (the “Original Registration Statement”). For your convenience, we have repeated the comment prior to the response in italics. Exhibit 3.1 – Amended and Restated Certificate of Incorporation of Moleculin Biotech, Inc., page II-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 revise your prospectus to clearly describe this provision and to describe any risks or other impacts on DC\82156171.1 Securities and Exchange Commission January 7, 2020 Page 2 investors. Risks may include, but are not limited to, increased costs to bring a claim and that these provisions can discourage claims or limit investors’ ability to bring a claim in a judicial forum that they find favorable. Also 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 also ensure that the exclusive forum provision in the governing document states this clearly, or 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 proposes to add the following disclosure in the section “Description of Common Stock” of the Original Registration Statement: “Exclusive Forum Provision. Our certificate of incorporation provides that the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for (i) any derivative action or proceeding brought our behalf, (ii) any action asserting a claim of breach of a fiduciary duty owed by any of our directors or officers to us or our stockholders, (iii) any action asserting a claim against us arising pursuant to any provision of the Delaware General Corporation Law, or our certificate of incorporation or the bylaws, and (iv) any action asserting a claim against us governed by the internal affairs doctrine. This provision would not apply to suits brought to enforce a duty or liability created by the Exchange Act or Securities Act. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and employees. In addition, these provisions could increase the costs to stockholders in bringing such claims. Alternatively, a court could find these provisions of our certificate of incorporation to be inapplicable or unenforceable in respect of one or more of the specified types of actions or proceedings, which may require us to incur additional costs associated with resolving such matters in other jurisdictions, which could adversely affect our business and financial condition.” The Company advises the Staff that it will make the above disclosure in its next Form 10-K filing, which is due on or before March 30, 2019, as well as in all future registration statements it files under the Securities Act. DC\82156171.1 Securities and Exchange Commission January 7, 2020 Page 3 * * * Should you have any questions regarding the foregoing, please do not hesitate to contact Cavas Pavri at (202) 724-6847. Sincerely, SCHIFF HARDIN LLP /s/ Cavas Pavri By: Cavas Pavri Enclosures cc: Jonathan P. Foster, Chief Financial Officer DC\82156171.1
2020-01-06 - UPLOAD - Moleculin Biotech, Inc.
January 6, 2020
Walter V. Klemp
Chief Executive Officer
Moleculin Biotech, Inc.
5300 Memorial Drive, Suite 950
Houston, TX 77007
Re:Moleculin Biotech, Inc.
Registration Statement on Form S-3
Filed December 23, 2019
File No. 333-235686
Dear Mr. Klemp:
We have limited our review of your registration statement to those issues we have
addressed in our comment. In our comment, 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 our comment, we may have additional comments.
Registration Statement on Form S-3 filed December 23, 2019
Exhibit 3.1 – Amended and Restated Certificate of Incorporation of Moleculin Biotech, Inc.,
page II-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 revise your prospectus to clearly describe this provision and to describe
any risks or other impacts on investors. Risks may include, but are not limited to,
increased costs to bring a claim and that these provisions can discourage claims or limit
investors’ ability to bring a claim in a judicial forum that they find favorable. Also
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
FirstName LastNameWalter V. Klemp
Comapany NameMoleculin Biotech, Inc.
January 6, 2020 Page 2
FirstName LastName
Walter V. Klemp
Moleculin Biotech, Inc.
January 6, 2020
Page 2
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 also ensure that the exclusive forum
provision in the governing document states this clearly, or 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.
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.
You may contact Tim Buchmiller at (202) 551-3635 or Jeffrey Gabor, Senior Attorney, at
(202) 551-2544 if you have any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Cavas S. Pavri, Esq.
2018-10-25 - CORRESP - Moleculin Biotech, Inc.
CORRESP
1
filename1.htm
October 25,
2018
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporate Finance
Washington, DC 20549
Re: Moleculin Biotech, Inc.
Registration Statement on Form
S-1
Registration No. 333-227845
Ladies and Gentlemen:
Reference is made to
the letter request of Moleculin Biotech, Inc., a Delaware corporation (the “Company”), for acceleration of effectiveness
of the above-captioned registration statement submitted to the U.S. Securities and Exchange Commission (the “Commission”)
on October 24, 2018, pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Acceleration Request”).
The Acceleration Request
inadvertently included an incorrect date for acceleration. The undersigned hereby respectfully requests that the Commission withdraw
the Acceleration Request and that it not declare the above-captioned registration statement effective until such time as the Company
shall request pursuant to a new request.
Very truly yours,
Moleculin Biotech, Inc.
By:
/s/ Jonathan Foster
Name: Jonathan Foster
Title: Chief Financial Officer
2018-10-25 - CORRESP - Moleculin Biotech, Inc.
CORRESP
1
filename1.htm
October 25,
2018
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporate Finance
Washington, DC 20549
Re: Moleculin Biotech, Inc.
Registration Statement on Form
S-1
Registration No. 333-227845
Ladies and Gentlemen:
Pursuant to Rule 461
of the Securities Act of 1933, as amended, Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby
respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be
declared effective at 4:30 P.M. (Eastern Time) on October 26, 2018, or as soon thereafter as possible on such date.
Very truly yours,
Moleculin Biotech, Inc.
By:
/s/ Jonathan Foster
Name: Jonathan Foster
Title: Chief Financial Officer
2018-10-24 - CORRESP - Moleculin Biotech, Inc.
CORRESP
1
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October 24,
2018
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporate Finance
Washington, DC 20549
Re: Moleculin Biotech, Inc.
Registration Statement on Form
S-1
Registration No. 333-227845
Ladies and Gentlemen:
Pursuant to Rule 461
of the Securities Act of 1933, as amended, Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby
respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be
declared effective at 4:30 P.M. (Eastern Time) on October 24, 2018, or as soon thereafter as possible on such date.
Very truly yours,
Moleculin Biotech, Inc.
By:
/s/ Jonathan Foster
Name: Jonathan Foster
Title: Chief Financial Officer
2018-10-23 - UPLOAD - Moleculin Biotech, Inc.
October 23, 2018
Walter Klemp
Chief Executive Officer
Moleculin Biotech, Inc.
5300 Memorial Drive, Suite 950
Houston, TX 77007
Re:Moleculin Biotech, Inc.
Registration Statement on Form S-1
Filed October 15, 2018
File No. 333-227845
Dear Mr. Klemp:
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 Dorrie Yale at 202-551-8776 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Cavas S. Pavri
2018-07-19 - CORRESP - Moleculin Biotech, Inc.
CORRESP 1 filename1.htm Document July 19, 2018 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Re: Moleculin Biotech, Inc. Registration Statement on Form S-1 Registration No. 333-226146 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 4:30 P.M. (Eastern Time) on July 23, 2018, or as soon thereafter as possible on such date. Very truly yours, Moleculin Biotech, Inc. By: /s/ Jonathan Foster Name: Jonathan Foster Title: Chief Financial Officer DC\81953691.1
2018-07-19 - UPLOAD - Moleculin Biotech, Inc.
July 19, 2018
Walter Klemp
Chief Executive Officer
Moleculin Biotech, Inc.
2575 West Bellfort, Suite 333
Houston, TX 77054
Re:Moleculin Biotech, Inc.
Registration Statement on Form S-1
Filed July 12, 2018
File No. 333-226146
Dear Mr. Klemp:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Christine Westbrook at 202-551-5019 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Cavas S. Pavri, Esq.
2018-05-23 - CORRESP - Moleculin Biotech, Inc.
CORRESP 1 filename1.htm Document May 23, 2018 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance Washington, DC 20549 Re: Moleculin Biotech, Inc. Registration Statement on Form S-1 Registration No. 333-224243 Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended, Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 4:30 P.M. (Eastern Time) on May 24, 2018, or as soon thereafter as possible on such date. Very truly yours, Moleculin Biotech, Inc. By: /s/ Jonathan Foster Name: Jonathan Foster Title: Chief Financial Officer DC\81934573.1
2017-08-18 - CORRESP - Moleculin Biotech, Inc.
CORRESP
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MOLECULIN
BIOTECH, INC.
2575
West Bellfort, Suite 333
Houston, Texas 77054
August 17, 2017
By EDGAR Submission
Securities and Exchange Commission
Division of Corporation Finance
Office of Healthcare & Insurance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Christine Westbrook, Esquire
Re: Moleculin Biotech, Inc.
Registration Statement on Form
S-3
File No. 333-219434
Request for Acceleration of Effective
Date
Dear Ms. Westbrook:
Pursuant to Rule 461
of the General Rules and Regulations under the Securities Act of 1933, as amended, Moleculin Biotech, Inc. (the “Company”)
hereby requests that the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the
above-referenced Shelf Registration Statement on Form S-3 and declare the Shelf Registration Statement effective as of 4:30 PM,
Eastern Time, on August 21, 2017, or as soon thereafter as possible.
In connection with
this request for acceleration, the Company acknowledges that:
· should
the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission
from taking any action with respect to the filing;
· the action
of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the
Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and
· the Company
may not assert staff comments and the declaration of effectiveness as defense in any proceeding initiated by the Commission or
any person under the federal securities laws of the United States.
Sincerely,
Moleculin Biotech, Inc.
/s/ Jonathan Foster
By: Jonathan Foster
Title: Chief Financial Officer and Executive Vice President
2017-08-11 - CORRESP - Moleculin Biotech, Inc.
CORRESP
1
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100
N. 18th Street
Suite 300
Philadelphia,
PA 19103
t
202.778.6400
f
202.778.6460
www.schiffhardin.com
Cavas S. Pavri
202.724.6847
cpavri@schiffhardin.com
August 11, 2017
By EDGAR Submission
Securities and Exchange Commission
Division of Corporation Finance
Office of Healthcare & Insurance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Christine Westbrook, Esquire
Re: Moleculin Biotech, Inc.
Registration Statement on Form
S-3
Filed July 24, 2017
File No. 333-219434
Dear Ms. Westbrook:
This letter is being
submitted on behalf of Moleculin Biotech, Inc. (“MBI” or the “Company”) in response to the comment letter,
dated July 31, 2017, of the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange
Commission (the “Commission”) with respect to the Company’s Registration Statement on Form S-3 filed on July
24, 2017 (the “Registration Statement”). The Company’s Amendment No. 1 to the Registration Statement (the “Amended
Registration Statement”) has been filed with the Commission.
For your convenience,
we have repeated the comment prior to the response in italics. We welcome any questions you may have about our comments or any
other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter.
Cover Page
1. It appears that you are relying on General Instruction I.B.6 of Form S-3. If true, please
revise your prospectus cover page to disclose the calculation of the aggregate market value of your outstanding voting and nonvoting
common equity and the amount of all securities offered pursuant to General Instruction I.B.6 during the prior 12 calendar month
period that ends on, and includes, the date of the prospectus. Refer to Instruction 7 to General Instruction I.B.6. Otherwise,
please provide us your analysis demonstrating your eligibility to use Form S-3.
Securities and Exchange Commission
August 11, 2017
Page 2
Response: The Company has revised
the cover page of the prospectus included in the Amended Registration Statement to include the following:
“As of August 1, 2017, the
aggregate market value of our outstanding common stock held by non-affiliates was approximately $35,633,714, based on
20,261,904 shares of outstanding common stock, of which approximately 13,148,972 shares are held by non-affiliates, and a per
share price of $2.71 based on the closing sales price of our common stock on August 1, 2017. As of the date hereof, we have
not offered any securities pursuant to General Instruction I.B.6 of Form S-3 during the prior 12 calendar month period that
ends on and includes the date hereof.”
* * *
Should you have any
questions regarding the foregoing, please do not hesitate to contact Cavas Pavri at (202) 724-6847.
Sincerely,
SCHIFF HARDIN LLP
/s/ Cavas Pavri
By: Cavas Pavri
Enclosures
cc: Jonathan Foster, Chief Financial Officer
2017-08-01 - UPLOAD - Moleculin Biotech, Inc.
July 31, 2017 Walter V. Klemp Chief Executive Officer Moleculin Biotech, Inc. 2575 West Bellfort, Suite 333 Houston, TX 77054 Moleculin Biotech, Inc. Registration Statement on Form S-3 Filed July 24, 2017 File No. 333-219434Re: Dear Mr. Klemp: We have limited our review of your registration statement to those issues we have addressed in our comment. In our comment, 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. S-3 filed 7/24/17 Cover Page 1. It appears that you are relying on General Instruction I.B.6 of Form S-3. If true, please revise your prospectus cover page to disclose the calculation of the aggregate market value of your outstanding voting and nonvoting common equity and the amount of all securities offered pursuant to General Instruction I.B.6 during the prior 12 calendar month period that ends on, and includes, the date of the prospectus. Refer to Instruction 7 to General Instruction I.B.6. Otherwise, please provide us your analysis demonstrating your eligibility to use Form S-3. Walter V. Klemp Moleculin Biotech, Inc. July 31, 2017 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 Christine Westbrook at (202) 551-5019 or Mary Beth Breslin at (202) 551- 3625 with any other questions. Division of Corporation Finance Office of Healthcare & Insurance cc: Cavas S. Pavri, Esq.
2017-02-08 - CORRESP - Moleculin Biotech, Inc.
CORRESP
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February 8,
2017
VIA FACSIMILE AND EDGAR
U.S. Securities and Exchange Commission
Division of Corporate Finance
Washington, DC 20549
Re: MOLECULIN BIOTECH, INC.
Registration Statement on Form
S-1 (Registration No. 333-214898) -
Concurrence
in Acceleration Request
Ladies and Gentlemen:
Roth Capital Partners,
LLC (“Roth”), as underwriter for the referenced offering, hereby concurs in the request by Moleculin Biotech,
Inc. that the effective date of the above-referenced registration statement be accelerated to 5:30 P.M. (Eastern Time) on February
8, 2017, or as soon as practicable thereafter, pursuant to Rule 461 under the Securities Act. Roth affirms that it is aware of
its obligations under the Securities Act in connection with this offering.
Very truly yours,
ROTH CAPITAL PARTNERS, LLC
By:
/s/ Aaron M. Gurewitz
Name: Aaron M. Gurewitz
Title: Head of Equity Capital Markets
2017-02-08 - CORRESP - Moleculin Biotech, Inc.
CORRESP
1
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February 8,
2017
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporate Finance
Washington, DC 20549
Re: Moleculin Biotech, Inc.
Registration
Statement on Form S-1
Registration
No. 333-214898
Ladies and Gentlemen:
Pursuant to Rule 461
of the Securities Act of 1933, as amended, Moleculin Biotech, Inc., a Delaware corporation (the “Company”), hereby
respectfully requests that the effective date for the Registration Statement referred to above be accelerated so that it will
be declared effective at 5:30 P.M. (Eastern Time) on February 8, 2017, or as soon thereafter as possible on such date.
Very truly yours,
Moleculin Biotech, Inc.
By:
/s/ Jonathan Foster
Name: Jonathan Foster
Title: Chief Financial Officer
2017-02-08 - CORRESP - Moleculin Biotech, Inc.
CORRESP
1
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February 8,
2017
VIA FACSIMILE AND EDGAR
U.S. Securities and Exchange Commission
Division of Corporate Finance
Washington, DC 20549
Re: MOLECULIN BIOTECH, INC.
Registration
Statement on Form S-1 (Registration No. 333-214898) -
Concurrence in Acceleration Request
Ladies and Gentlemen:
National Securities
Corporation (“National”), as underwriter for the referenced offering, hereby concurs in the request by Moleculin
Biotech, Inc. that the effective date of the above-referenced registration statement be accelerated to 5:30 P.M. (Eastern Time)
on February 8, 2017, or as soon as practicable thereafter, pursuant to Rule 461 under the Securities Act. National affirms that
it is aware of its obligations under the Securities Act in connection with this offering.
Very truly yours,
NATIONAL SECURITIES CORPORATION
By:
/s/ Jonathan Rich
Name: Jonathan Rich
Title: Executive Vice President
2017-01-18 - CORRESP - Moleculin Biotech, Inc.
CORRESP
1
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100 N. 18th Street
Suite 300
Philadelphia, PA 19103
t 202.778.6400
Cavas S. Pavri
f 202.778.6460
202.724.6847
cpavri@schiffhardin.com
www.schiffhardin.com
January 18, 2017
By EDGAR Submission
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Suzanne Hayes, Assistant Director
Re: Moleculin Biotech, Inc.
Registration Statement on Form
S-1
Filed December 2, 2016
File No. 333-214898
Dear Ms. Hayes:
This letter is being
submitted on behalf of Moleculin Biotech, Inc. (“MBI” or the “Company”) in response to the comment letter,
dated December 19, 2016, of the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange
Commission (the “Commission”) with respect to the Company’s Registration Statement on Form S-1 filed on December
2, 2016 (the “Registration Statement”). The Company’s Amendment No. 1 to the Registration Statement (the “Amended
Registration Statement”) has been filed with the Commission.
For your convenience,
we have repeated each comment prior to the response in italics. We welcome any questions you may have about our comments or any
other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter.
Cover Page
1. Although Rule 430A of the Securities Act of 1933 permits registrants to omit certain pricing-related
information from a registration statement that is declared effective, your filing must include the amount of securities to be offered
in a pre-effective amendment. Accordingly, please confirm that you will revise your disclosure to specify: (i) the number of units
to be offered; (ii) the number of shares of common stock per each unit; and (iii) the number of warrants per each unit.
Securities and Exchange Commission
January 18, 2017
Page 2
Response: The Company respectfully
advises the Staff that the Amended Registration Statement includes: (i) the number of units to be offered (5,000,000 Units); the
number of shares of common stock per each unit (one share per Unit); and (iii) the number of warrants per each unit (a warrant
to purchase 0.25 of a share of common stock).
* * *
Should you have any
questions regarding the foregoing, please do not hesitate to contact Cavas Pavri at (202) 724-6847.
Sincerely,
SCHIFF HARDIN LLP
/s/ Cavas Pavri
By: Cavas Pavri
Enclosures
cc: Jonathan Foster, Chief Financial Officer
2016-12-19 - UPLOAD - Moleculin Biotech, Inc.
Mail Stop 4546 December 19 , 2016 Walter V. Klemp Director and Chief Executive Officer Moleculin Biotech, Inc. 2575 West Bellfort, Suite 333 Houston, TX 77054 Re: Moleculin Biotech, Inc. Registration Statement on Form S -1 Filed December 2 , 2016 File No. 333-214898 Dear Mr . Klemp: We have limited our review of your registration statement to those issues we have addressed in our comment. In our comment , 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 y our response. After reviewing any amendment to your registration statement and the information you provide in response to this comment , we may have additional comments. Cover Page 1. Although Rule 430A of the Securities Act of 1933 permits registrants to omit certain pricing - related information from a registration statement that is declared effective, your filing must include the amount of securities to be offered in a pre -effective amendment. Accordingly, please confirm that you will revise your discl osure to specify: (i) the number of units to be offered; (ii) the number of shares of common stock per each unit; and (iii) the number of warrants per each unit. 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. Walter V. Klemp Moleculin Biotech, Inc. December 19 , 2016 Page 2 Refer to Rules 460 and 461 regarding requests for accele ration . Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Josh Samples at (202) 551 -3199 or Joseph McCann at (202) 551 -6262 with any questions. Sincerely, /s/ Joseph McCann for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Cavas S. Pavri Schiff Hardin LLP
2016-04-28 - CORRESP - Moleculin Biotech, Inc.
CORRESP
1
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Moleculin Biotech, Inc.
2575 West Bellfort
Suite 333
Houston, TX 77054
April 28, 2016
Via EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Scot Foley
RE:
Moleculin Biotech, Inc.
Registration Statement on Form S-1 (No. 333-209323) (“Registration Statement”)
Ladies and Gentlemen:
Pursuant to Rule 461 of the Securities Act
of 1933, as amended (the “Act”), Moleculin Biotech, Inc. (the “Company”) hereby respectfully requests that
the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration
Statement to become effective on May 2, 2016 at 4:30 p.m. Eastern Time, or as soon thereafter as practicable. In making this acceleration
request, the Company acknowledges that it is aware of its responsibilities under the Act.
In connection with the foregoing, the Company
acknowledges that:
· should the Commission or the staff of the Commission (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;
· the action of the Commission or the Staff, acting pursuant to delegated
authority, in declaring the Registration Statement effective, does not relieve the Company from its full responsibility for the
adequacy and accuracy of the disclosure in the Registration Statement; and
· the Company may not assert Staff comments and the declaration of effectiveness
as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Once the Registration Statement is effective,
please orally confirm the event with our counsel Schiff Hardin LLP by calling Cavas Pavri at (202) 724-6847.
Very truly yours,
Moleculin Biotech, Inc.
/s/ Walter Klemp
Walter Klemp
Acting Chief Executive Officer
2016-04-28 - CORRESP - Moleculin Biotech, Inc.
CORRESP
1
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[LETTERHEAD OF BONWICK CAPITAL]
April 28, 2016
United States Securities and Exchange
Commission
100 F Street, N.E.
Washington, DC 20549-3628
Attn: Scot Foley, Esq., Staff Attorney
Division of Corporation Finance
Re: Moleculin Biotech, Inc. Registration Statement No. 333-209323
In connection
with the above-referenced Registration Statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”),
we hereby join in the request of Moleculin Biotech, Inc. that the effective date of the above-referenced registration statement
be accelerated so that it will be declared effective at 4:30 p.m., Eastern Daylight Time, on May 2, 2016, or as soon as practicable
thereafter.
Pursuant to Rule
460 under the Act, please be advised that we have distributed approximately 160 copies of the Preliminary Prospectus dated April
26, 2016 (the “Preliminary Prospectus”), through the date hereof, to dealers, institutions and others.
In connection
with the Preliminary Prospectus distribution for the above-referenced issue, as sole underwriter we confirm that we are complying
with the 48-hour requirement as promulgated by Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very truly yours,
BONWICK CAPITAL PARTNERS LLC
By: /s/ Devin Wicker
Devin Wicker
CEO
Bonwick Capital Partners
40 W 57th street, 28th floor
New York, NY 10019
2016-04-15 - CORRESP - Moleculin Biotech, Inc.
CORRESP
1
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100 N. 18th Street
Suite 300
Philadelphia, PA 19103
t 202.778.6400
f 202.778.6460
Cavas S. Pavri
202.724.6847
www.schiffhardin.com
cpavri@schiffhardin.com
April 15, 2016
By EDGAR Submission
and
Overnight Delivery
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Suzanne Hayes, Assistant Director
Re: Moleculin Biotech, Inc.
Amendment No. 2 to Registration Statement on Form S-1
Filed March 22, 2016
File No. 333-209323
Dear Ms. Hayes:
This letter is being
submitted on behalf of Moleculin Biotech, Inc. (“MBI” or the “Company”) in response to the comment letter,
dated April 12, 2016, of the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange
Commission (the “Commission”) with respect to the Company’s Registration Statement on Form S-1 filed on March
22, 2016 (the “Amendment No. 2 Registration Statement”). The Company’s Amendment No. 3 to the Form S-1 Registration
Statement (the “Registration Statement”) is being filed with the Commission concurrently herewith.
For your convenience,
we have repeated each comment prior to the response in italics. The references to page numbers in the headings are to the Amendment
No. 2 Registration Statement. We welcome any questions you may have about our comments or any other aspect of our review. Feel
free to call us at the telephone numbers listed at the end of this letter.
Securities and Exchange Commission
April 15, 2016
Page 2
Risk Factors
Risks Relating to
our Business
“We have completed
and will in the future complete related party transactions that were not and will not be conducted on an arm’s length basis,”
page 12
1. Please clarify your response to prior comment 2 to state whether the related party transactions
you did not conduct on an arm’s length basis resulted in terms that are similar to a third party agreement. If the terms
were more favorable to you than they would have been with a third party, tell us how you accounted for the more favorable terms..
Response: The Company respectfully
advises the Staff that it believes each of the related party transactions referenced in the Registration Statement resulted in
terms that are similar to a third party agreement. However, the Company included disclosure in the risk factors stating that it
is possible that the terms were less favorable to the Company than in an arm’s length transaction to make investors aware
of the risks associated with the related party transactions. As the Company believes that each of the related party transactions
were conducted with terms that are similar to a third party agreement, the Company believes that there is no additional accounting
to be recorded.
Business, page 42
2. We note your response to prior comment 9 and the associated revised disclosure in the
prospectus. On page 42
in the section “Business – Corporate History,” please make the
following revisions and
any necessary conforming revisions throughout the prospectus:
· When you refer to Dr. Shepard and the data reported in the Callisto-sponsored
research trials, please
reiterate here that Dr. Shepard is also currently your Chief
Medical Officer;
· Please remove from your discussion the conclusion reported at the 2009 ASCO
presentation that “Nanomolecular
Liposomal Annamycin was effective even in
refractory ALL,”
as this statement does not appear in the journal article reporting
the results of the trial
and was not subject to peer review, unlike the article.
Moreover, the use of the
term “effective” in this instance does not appear
consistent with the concept
of efficacy as applied by the FDA and may confuse
investors;
Securities and Exchange Commission
April 15, 2016
Page 3
· If you retain the discussion regarding the observed efficacy signal and the
definition of efficacy
as used in the Phase I/II ALL study, please define the term
“efficacy signal”
as used in the journal article and make clear that neither the
patient responses observed
nor the criteria underlying an “efficacy signal” would
satisfy the FDA’s
standards for proof of efficacy; and
· Disclose that the study’s conclusion, as reported in the journal article, was only
that Annamycin had “encouraging
anti-leukemic activity.”
Response: The
Company respectfully advises the Staff that it has made the requested changes set forth in bullets 1 and 4 above. With respect
to bullet 2, the Company has deleted the sentence referencing the conclusion of the ASCO presentation. With respect to bullet 3,
the Company has deleted the phrase “efficacy signal” and has instead disclosed that the study demonstrated “encouraging
anti-leukemic activity” to be consistent with the prior disclosure.
Moleculin, LLC
Statements of Operations, page F-13
3. Please tell us why your research and development expenses decreased from $270,991 at September
30, 2015 to $125,442 at December 31, 2015.
Response: The
Company respectfully advises the Staff that the research and development expenses decreased from $270,991 for the nine months
ended September 30, 2015 to $125,442 for the year ended December 31, 2015 as a result of Moleculin, LLC receiving $175,000 from
Dermin, Sp. Zo. O. during the fourth quarter of 2015 for reimbursement of certain research and development expenses. The reimbursement
amount, if any, was uncertain at September 30, 2015.
* * *
Should you have any
questions regarding the foregoing, please do not hesitate to contact Cavas Pavri at (202) 724-6847.
Securities and Exchange Commission
April 15, 2016
Page 4
Sincerely,
SCHIFF HARDIN LLP
/s/ Cavas Pavri
By: Cavas Pavri
Enclosures
cc: Walter Klemp, Acting Chief Executive Officer
Louis Ploth, Chief Financial Officer
2016-04-13 - UPLOAD - Moleculin Biotech, Inc.
Mail Stop 4720
April 12, 2016
Via E -mail
Walter Klemp
Chief Executive Officer
Moleculin Biotech, Inc.
2575 West Bellfort, Suite 333
Houston, Texas 77054
Re: Moleculin Biotech, Inc.
Amendment No. 2 to Registration Statement on Form S -1
Filed March 22, 2016
File No. 333 -209323
Dear Mr. Klemp :
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 March 4, 2016 letter .
Risk Factors
Risks Relating to our Business
“We have completed and will in the future complete related party transactions that were not and
will not be conducted on an arm’s length basis, ” page 12
1. Please clarify your response to prior comment 2 to state whether the related party
transactions you did not conduct on an arm’s length basis resulted in terms that are
similar to a third party agreement. If the terms were more favorable to you than they
would have been with a third party, tell us how you accounted for the more favorable
terms.
Walter Klemp
Moleculin Biotech, Inc.
April 12, 2016
Page 2
Business, page 42
2. We note your response to prior comment 9 and the associated revise d disclosure in the
prospectus. On page 42 in the section “Business – Corporate History,” please make the
following revisions and any necessary conforming revisions throughout the prospectus:
When you refer to Dr. Shepard and the data reported in the Callisto -sponsored
research trials, please reiterate here that Dr. Shepard is also curre ntly your Chief
Medical Officer ;
Please remove from your discussion the concl usion reported at the 2009 ASCO
presentation that “Nanomolecular Lipos omal Annamycin was effective even in
refractory ALL,” as this statement does not appear in the journal article reporting
the results of the trial and was not subject to peer review , unlike the article .
Moreover, the use of the term “effective” in this instance does not appear
consistent with the concept of efficacy as applied by the FDA and may confuse
investors;
If you retain the disc ussion regarding the observed efficacy signal and the
definition of efficacy as used in the Phase I/II ALL study, please define the term
“efficacy signal” as used in the journal article and make clear that neither the
patient response s observed nor the criteria underlying an “efficacy signal” would
satisfy the FDA’s standards for proof of efficacy ; and
Disclose that the study’s conclus ion, as reported in the journal article, was only
that Annamycin had “encouraging anti -leukemic activity.”
Moleculin, LLC
Statements of Operations, page F -13
3. Please tell us why your research and development expenses decreased from $270,991 at
September 30, 2015 to $12 5,442 at December 31, 2015.
Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their respective responsibilities under
the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the securities specified in the above registration statement. Please allow
adequate time for us to review any amendment prior to the requested effective date o f the
registration statement.
Walter Klemp
Moleculin Biotech, Inc.
April 12, 2016
Page 3
You may contact Keira Nakada at (202) 551 -3659 or Lisa Vanjoske at (202) 551 -3614 if
you have questions regarding comments on the financial statements and related matters. Please
contact Scot Foley at (202) 551 -3383, Daniel Greenspan at (202 ) 551 -3623 or me at (202) 551 -
3675 with any other questions.
Sincerely,
/s/ Daniel Greenspan for
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
cc: Cavas S. Pavri
Schiff Hardin LLP
2016-03-21 - CORRESP - Moleculin Biotech, Inc.
CORRESP
1
filename1.htm
100
N. 18th Street
Suite 300
Philadelphia, PA 19103
t
202.778.6400
f
202.778.6460
www.schiffhardin.com
Cavas S. Pavri
202.724.6847
cpavri@schiffhardin.com
March 21, 2016
By EDGAR Submission
and
Overnight Delivery
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Suzanne Hayes, Assistant Director
Re: Moleculin Biotech, Inc.
Registration Statement on Form S-1
Filed February 1, 2016
Amendment No. 1 to Registration Statement on Form S-1
Filed February 16, 2016
File No. 333-209323
Dear Ms. Hayes:
This letter is being
submitted on behalf of Moleculin Biotech, Inc. (“MBI” or the “Company”) in response to the comment letter,
dated March 4, 2016, of the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange
Commission (the “Commission”) with respect to the Company’s Registration Statement on Form S-1 filed on February
1, 2016 (the “Original Registration Statement”) and the Amendment No. 1 to the Registration Statement on Form S-1 filed
February 16, 2016 (the “Amendment No. 1 Registration Statement”). The Company’s Amendment No. 2 to the Form S-1
Registration Statement (the “Registration Statement”) is being filed with the Commission concurrently herewith.
For your convenience,
we have repeated each comment prior to the response in italics. The references to page numbers in the headings are to the Original
Registration Statement. We welcome any questions you may have about our comments or any other aspect of our review. Feel free to
call us at the telephone numbers listed at the end of this letter.
Securities and Exchange Commission
March 21, 2016
Page 2
Registration Statement
on Form S-1
Company Information
and Moleculin Merger, page 5
1. Please tell us how you will account for the operating loans to Moleculin in the amount of
$300,000 to $310,000 that will be forgiven at the completion of the IPO. Cite the relevant accounting literature to support your
accounting.
Response: The Company respectfully
advises the Staff that as these operating loans are forgiven as a result of MBI’s acquisition of Moleculin, the Company will
follow the guidance under ASC 805-10-55-21 for the forgiveness. That is, the consideration paid by MBI will include the balance
of the outstanding receivable from Moleculin that will be forgiven as of the acquisition date. If there is a difference between
the fair value and the carrying value of the operating loans, a gain or loss will be recognized upon forgiveness.
Risk Factors, page 11
“We have completed and will in the future complete
related party transactions…,” page 12
2. Please describe for us the related party transactions you did not conduct on an arm’s
length basis how you accounted for them.
Response: The
Company respectfully advises the Staff that as discussed in the referenced risk factor on page 11 of the Registration Statement
and in Note 3 to the financial statements, the Company had the following related party transactions:
1. On August 11,
2015, the Company was granted an assignment of a license agreement between MD Anderson and IntertechBio Corporation, a Company
affiliated with certain members of the Company’s management and board of directors, in exchange for 630,000 shares of the
Company’s common stock. The sublicense gives the Company rights to access certain metabolic inhibitor technology owned by
MD Anderson that had been licensed to IntertechBio. The shares were valued at a total of $630 and the related expense is included
in research and development costs.
2. On August 21,
2015, the Company acquired the right to the intellectual property of AnnaMed Inc., a company affiliated with certain members of
the Company’s management and board of directors, in exchange for 1,431,000 shares of the Company’s common stock. The
license gives the Company full ownership rights to the data package supporting the FDA IND Number 46869, allowing the Company to
resubmit a request for IND to the FDA to begin development work on Annamycin. The shares were valued at $1,431 and the related
expense is included in research and development costs.
These transactions
occurred shortly after the inception of the Company. Although these transactions were not conducted on an arm’s length basis,
management of the Company believes that the terms of the transactions were not less favorable to the Company than in an arm’s
length transaction.
“The intellectual property rights we have licensed
from MD Anderson…,” page 18
Securities and Exchange Commission
March 21, 2016
Page 3
3. Please restore your deleted statement about your knowledge of any funding agreements that
would impinge on the IP rights you have licensed from MD Anderson and specify the extent of your due diligence to confirm this
fact.
Response: In
response to the Staff’s comment, the Company has substantially revised the referenced risk factor to better explain the legal
basis for the potential governmental rights to the IP. The revised risk factor is as follows:
“The intellectual property rights we have licensed
from MD Anderson are subject to the rights of the U.S. government.
We have obtained a royalty-bearing, worldwide,
exclusive license to intellectual property rights, including patent rights related to our WP1066 Portfolio and WP1122 Portfolio
drug product candidates from MD Anderson. Some of our licensed intellectual property rights from MD Anderson have been developed
in the course of research funded by the U.S. government. As a result, the U.S. government may have certain rights to intellectual
property embodied in our current or future products pursuant to the Bayh-Dole Act of 1980. Government rights in certain inventions
developed under a government-funded program include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions
for any governmental purpose. In addition, the U.S. government has the right to require us, or an assignee or exclusive licensee
to such inventions, to grant licenses to any of these inventions to a third party if they determine that: (i) adequate steps have
not been taken to commercialize the invention; (ii) government action is necessary to meet public health or safety needs; (iii)
government action is necessary to meet requirements for public use under federal regulations; or (iv) the right to use or sell
such inventions is exclusively licensed to an entity within the U.S. and substantially manufactured outside the U.S. without the
U.S. government’s prior approval. Additionally, we may be restricted from granting exclusive licenses for the right to use
or sell our inventions created pursuant to such agreements unless the licensee agrees to additional restrictions (e.g., manufacturing
substantially all of the invention in the U.S.). The U.S. government also has the right to take title to these inventions if we
fail to disclose the invention to the government and fail to file an application to register the intellectual property within specified
time limits. In addition, the U.S. government may acquire title in any country in which a patent application is not filed within
specified time limits. Additionally, certain inventions are subject to transfer restrictions during the term of these agreements
and for a period thereafter, including sales of products or components, transfers to foreign subsidiaries for the purpose of the
relevant agreements, and transfers to certain foreign third parties. If any of our intellectual property becomes subject to any
of the rights or remedies available to the U.S. government or third parties pursuant to the Bayh-Dole Act of 1980, this could impair
the value of our intellectual property and could adversely affect our business.”
Use of Proceeds, page 25
4. Please indicate the extent to which you contemplate using offering proceeds to pay down existing
debt or to satisfy obligations, such as your installment payments to MD Anderson for past due fees, discussed on page F-18.
Response: The
Company respectfully advises the Staff that it has added disclosure to the “Use of Proceeds” section to indicate that
the working capital amount “[i]ncludes approximately $1.1 million representing outstanding licenses fees and past due obligations
to MD Anderson and other deferred obligation to certain vendors.”
Securities and Exchange Commission
March 21, 2016
Page 4
Management’s Discussion and Analysis of Financial Condition…,
page 37
Critical Accounting Policies and Significant Judgments and
Estimates, page 38
5. In your response to comment 17, you state that you estimate the fair value of your common
stock using the most recent selling price available. Please tell us the date, the number of shares sold for cash, your relationship
to the purchaser(s), and the stock price to support your debt conversion price of $0.1299 during August and September 2015 and
$0.20 during October and December 2015. Furthermore, to the extent your stock was sold to a related party, please tell us how you
determined that such transaction was conducted at an arm’s length.
Response: Below
is a table with the requested information:
Name of investor/creditor
Date
Price per share
Underlying Shares
Investor/Creditor Relationship with the Company
Common Stock Issuance for cash
Walter Klemp
7-Aug-15
$ 0.001
100,000
Chairman, Sole Board Member, Acting CEO
Waldamer Priebe
21-Aug-15
$ 0.001
3,000,000
Chair of Science Advisory Board
Walter Klemp
21-Aug-15
$ 0.001
1,000,000
Chairman, Sole Board Member, Acting CEO
Donald Picker
21-Aug-15
$ 0.001
500,000
President & COO
Total shares
4,600,000
Convertible Debt Issuance
Third party
31-Aug-15
$ 0.1299
962,279 (1)
Investor
Third party
3-Sep-15
$ 0.1299
962,279 (1)
Investor
Third party
6-Oct-15
$ 0.2000
735,000 (1)
Investor (Affiliate of investor acted as consultant to company)
Third party
6-Oct-15
$ 0.2000
15,000 (1)
Investor (Affiliate of investor acted as consultant to company)
Third party
28-Oct-15
$ 0.2000
250,000 (1)
Investor
Third party
14-Jan-15
$ 0.2000
412,500 (1)
Investor
Third party
19-Jan-15
$ 0.2000
412,500 (1)
Investor (Affiliate of investor acted as consultant to company)
3,749,557
Direct Sale of Pre-IPO Stock
All purchasers were third parties
From January 20, 2016 through March 15, 2016
$ 3.00
123,833
Investor
(1) No holder of the convertible debt is permitted to
convert such debt to the extent that the holder or any of its affiliates would beneficially own in excess of 4.99% of the Company's
common stock after such conversion. The amounts set forth in the table above reflect the total number of shares into which the
debt is convertible without regard to such limitation.
Securities and Exchange Commission
March 21, 2016
Page 5
The
Company advises the Staff that the only sales of common stock for cash consideration to related parties occurred at the time of
the initial formation of the Company, at such time the Company did not have any meaningful assets and the shares were sold at
par value.
6. Please explain the difference between the most recent common stock valuation of $0.20 on
December 30, 2015 and the midpoint of your current estimated IPO price of $5.50.
Response: The
Company advises the Staff that if the IPO is successful the common stock valuation will have risen from $0.20 per share in December
2015 to $3.00 per share in early 2016 to an expected IPO price of between $5-6 per share. The Company further advises the Staff
that the sales referenced in the comment were all made on an arms’ length basis and not to related parties.
With respect to the
$0.20 price per share, as disclosed in the previously filed registration statement, in October 2015, the Company issued the 8%
convertible notes that provided for the conversion rate of $0.20 per share. At the time of such purchase in October 2015, the convertible
note investors and the Company agreed that the investors would fund the Company up to the filing of the initial non-confidential
registration statement an additional $165,000 on the same terms as in the October financing. As such, the $0.20 valuation was agreed
upon in October 2015.
From October 2015 until
mid-January 2016 (when the Company sold shares to third parties at a price per share of $3.00), the Company’s IPO process
had progressed from the filing of the initial draft registration statement to the filing of the initial Form S-1. In addition,
the merger agreement between the Company and Moleculin LLC had been approved by Moleculin LLC’s board of directors and appeared
probable of closing. As such, the Company believed an increased valuation to $3.00 per share was justifiable and such belief was
validated by the willingness of unaffiliated, third party investors to purchase such shares from mid-January 2016 through the date
of this filing.
The Company believes
a further increase from the $3.00 per share price to an IPO price of between $5-6 per share is appropriate as the $3.00 price includes
the risk that the IPO will not be completed and such $3.00 shares are “restricted securities” and will not be able
to be transferred until permitted by Rule 144 of the Securities Act.
Research and Development Expense, page 39
7. Tell us why you believe patent prosecution fees are appropriately classified as research
and development expense.
Response: The
Company respectfully advises the Staff that it has revised the term used in the Registration Statement from “patent prosecution
fees” to “patent acquisition fees”.
Business, page 43
Our Drug Candidates, page 44
Annamycin, page 44
Securities and Exchange Commission
March 21, 2016
Page 6
8. We refer to our prior comment 19. Please revise your prospectus to disclose:
· the reason given by Callisto in its public filings for terminating further development of
Annamycin as a treatment for adult acute leukemia was that the clinical data did not support further clinical evaluation;
· the clinical data which you intend to use to apply for a new IND and on which you are basing
your assessment of Annamycin’s therapeutic potential are the data generated by Callisto in its earlier clinical trials, completed
in 2007; and
· the basis of your decision to move forward with the development of Annamycin notwithstanding
Callisto’s prior evaluation of this product candidate.
Response: The
Company has amended the paragraph in the Registration Statement in the section “Business – Corporate History”
referencing Callisto as follows:
“AnnaMed was
formed in 2012 to take over the development of Annamycin from a prior drug development company, Callisto Pharmaceuticals, Inc.,
or Callisto. Callisto ceased development work on Annamycin, leading to the termination of its IND by the FDA. Callisto disclosed
publicly in its Form 10-K filing for the year ended 2009 that the clinical data relating to acute leukemia patients “did
not support further clinical evaluation of L-Annamycin as a single agent to treat relapsed or refractory adult acute leukemia patients.”
In order to satisfy unmet license obligations, Callisto agreed to transfer all available Annamycin data to AnnaMed, which data
we will use to apply for a new IND. As such, notwithstanding Callisto’s determination to terminate its development of Annamycin,
we will be utilizing the clinical data from Callisto’s trials to apply for a new IND. The basis for our decision to proceed
notwithstanding Callisto’s determination is that we believe the actual clinical data as reported by Dr. Robert
2016-03-04 - UPLOAD - Moleculin Biotech, Inc.
Mail Stop 4720 March 4, 2016 Walter Klemp Chief Executive Officer Moleculin Biotech, Inc. 2575 West Bellfort, Suite 333 Houston, Texas 77054 Re: Moleculin Biotech , Inc. Registration Statement on Form S -1 Filed February 1, 2016 Amendment No. 1 to Registration Statement on Form S -1 Filed February 16, 2016 File No. 333-209323 Dear Mr. Klemp : We have reviewed your registration statement and amendment 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 you r 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 Company Information and Moleculin Merger, page 5 1. Please tell us how you will account for the operating loans to Mol eculin in the amount of $300,000 to $310,000 that will be forgiven at the completion of the IPO. Cite the relevant accounting literature to support your accounting. Risk F actors , page 11 “We have completed and will in the future complete related party transactions …,” page 12 2. Please describe for us the related party transactions you did not conduct on an arm’s length b asis how you accounted for them. Walter Klemp Moleculin Biotech, Inc. March 4, 2016 Page 2 “The intellectual property rights we have licensed from MD Anderson…, ” page 18 3. Please restore your deleted statement about your knowledge of any funding agreements that would impinge on the IP rights you have licensed from MD Anderson and specify the extent of your due diligence to confirm this fact. Use of P roceeds, page 25 4. Please indicate the extent to which you contemplate using offering proceeds to pay down existing debt or to satisfy obligations, such as yo ur installment payments to MD Anderson for past due fees, discussed on page F -18. Management’s Discussion and Analysis of Financial Condition …, page 37 Critical Accounting Policies and Significant Judgments and Estimates, page 38 5. In your re sponse to comment 1 7, you state that you estimate the fair value of your common stock using the most recent selling price available. Please tell us the date, the number of shares sold for cash, your relationship to the purchaser (s), and the stock price to support your debt conversion price of $0.1299 during August and September 2015 and $0.20 during October and December 2015. Furthermore, to the extent your stock was sold to a related party, please tell us how you determined that such transaction was conducted at an arm’s l ength. 6. Please explain the difference between the most recent common stock valuation of $0.20 on December 30, 2015 and the midpoint of your current estimated IPO price of $5.50. Research and Development Expense, page 39 7. Tell us why you believe patent prosecution fees are appropriately classified as research and development expense . Business, page 43 Our Drug Candidates , page 44 Annamycin, p age 4 4 8. We refer to our prior comment 19. Please revise your prospectus to disclose: the reason given by Callisto in its public filings for terminating further development of Annamycin as a treatment for adult acute leukemia was that the clinical data did not support further clinical evaluation; Walter Klemp Moleculin Biotech, Inc. March 4, 2016 Page 3 the clinical data which you intend to use to apply for a new IND and on which you are basing your assessment of Annamycin’s therapeutic potential are the data generated by Callisto in its earlier clinical trials, completed in 2007; and the basis of your decision to move forward with the development of Annamycin notwithstanding Calli sto’s prior evaluation of this product candidate. 9. In addition, we note your disclosure that Annamycin “demonstrated efficacy” in the prior Phase I study and “demonstrated a similar efficacy profile” in the subsequent Phase I/II study. However, the focus of the studies to which you refer was dose tolerance and patient safety, not product efficacy. As you acknowledge in your response to comment 19, the trials were “not designed to reach statistical significance” and therefore would not satisfy the FDA ’s standards for proof of efficacy. In fact, the study you cite concludes only that Annamycin “has encouraging anti -leukemic activity,” which is not sufficient to support a claim of efficacy. Accordingly, please remove from your prospectus any statements o r suggestion that Annamycin was effective or demonstrated efficacy in prior clinical trials, as the concept of “efficacy” is well -defined by the FDA and generally understood in the pharmaceutical industry to refer to measurable proof of a product’s effecti veness sufficient to support regulatory approval. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Secur ities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made . Notwithstanding our comments, in the event you request acceleration of the effective date of the pending regist ration statement , please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursua nt to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Walter Klemp Moleculin Biotech, Inc. March 4, 2016 Page 4 Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act o f 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. You may contact Keira Nakada at (202) 551 -3659 or Lisa Vanjoske at (202) 551 -3614 if you have questions regarding comments on the financial statements and related matters. Please contact Scot F oley at (202) 551 -3383, Daniel Greenspan at (202) 551 -3623 or me at (202) 551 - 3675 with any other questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Cavas S. Pavri , Esq.
2016-02-01 - CORRESP - Moleculin Biotech, Inc.
CORRESP
1
filename1.htm
100 N. 18th Street
Suite 300
Philadelphia, PA 19103
t 202.778.6400
f 202.778.6460
www.schiffhardin.com
Cavas S. Pavri
202.724.6847
cpavri@schiffhardin.com
February 1,
2016
By EDGAR Submission
and
Overnight Delivery
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-0404
Attention: Suzanne Hayes, Assistant Director
Re: Moleculin Biotech, Inc.
Draft Registration Statement on Form S-1
Submitted December 4, 2015
CIK No. 0001659617
Dear Ms. Hayes:
This letter is being
submitted on behalf of Moleculin Biotech, Inc. (“MBI” or the “Company”) in response to the comment letter,
dated December 31, 2015, of the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange
Commission (the “Commission”) with respect to the Company’s Draft Registration Statement on Form S-1 filed on
December 4, 2015 (“Draft Registration Statement”). The Company’s initial Form S-1 Registration Statement (the
“Registration Statement”) is being filed with the Commission concurrently herewith.
For your convenience,
we have repeated each comment prior to the response in italics. The references to page numbers in the headings are to the Draft
Registration Statement. We welcome any questions you may have about our comments or any other aspect of our review. Feel free to
call us at the telephone numbers listed at the end of this letter.
Comment Letter Dated
December 31, 2015
Table of Contents,
page i
Securities and Exchange Commission
February 1, 2016
Page 2
1. You state you have not independently verified any of the market and industry data used throughout
your prospectus, and that the accuracy and completeness of such information is not guaranteed. In order to eliminate any inference
that you are not liable for all of the information in your registration statement, please delete this statement or include a statement
specifically acknowledging your liability for information that appears in your registration statement that was obtained from third
party sources.
Response: The Company acknowledges
the Staff’s comment and respectfully advises the Staff that it has deleted the statement referenced in the Staff’s
comment.
Prospectus Summary, page 1
2. Please explain, in layman’s terms, the meaning of “anthracycline.”
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the following disclosure
in the “Prospectus Summary” section of the Registration Statement to include the meaning of “anthracycline”:
“Our lead product
candidate is Annamycin, an anthracycline intended to target the treatment of relapsed or refractory AML. Anthracyclines are a class
of chemotherapy drugs designed to disrupt the DNA of, and eventually destroy, targeted cancer cells. They are considered to be
among the most effective anticancer drugs developed and are used to treat a range of cancers, including leukemias, lymphomas, and
breast, stomach, uterine, ovarian, bladder, and lung cancers. The effectiveness of currently approved anthracyclines is limited,
however, by their propensity to cause heart damage (cardiotoxicity) and for cancer cells to become resistant by natural cell defense
(multidrug resistance) mechanisms.”
Risks Related to Our Business, page 3
3. Please include a bullet point referencing the possibility of side effects in your product
candidates, noting that the most recent Phase I/II clinical trial of Annamycin caused two fatalities due to tumor lysis, as stated
on pages 2 and 16.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that it has added the following bullet point
in the “Prospectus Summary” section of the Registration Statement:
“• unforeseen
side effects from any of our product candidates could arise either during clinical development. For example, in the most recent
Phase I/II dose-ranging clinical trial of Annamycin, two patients succumbed to tumor lysis syndrome (TLS) resulting from the debris
created by Annamycin killing the targeted leukemic blasts more rapidly than anticipated;”
Securities and Exchange Commission
February 1, 2016
Page 3
4. Please include a bullet point that addresses your lack of product liability insurance for
your clinical trials.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that it has added the following bullet point
in the “Prospectus Summary” section of the Registration Statement:
“• we do
not currently carry product liability insurance covering any of our drug candidates and, although we intend to obtain product liability
insurance for future clinical trial liability that we may incur, there can be no assurance that we will secure adequate coverage
or that, even if we do so, any such coverage will be sufficient to prevent the exposure of our operations to significant potential
liability in the future;”
Risk Factors, page 11
5. Please include a risk factor addressing the related-party nature of your pending merger with
Moleculin LLC. In particular, because of your affiliation with Moleculin, the transaction by definition will not be conducted on
an arm’s-length basis. This raises the possibility, therefore, that the parties may agree on terms that are less favorable
to the company than in an arms-length negotiation.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that it has add the following new risk factor
in the Registration Statement:
“We have
completed and will in the future complete related party transactions that were not and will not be conducted on an arm’s
length basis.
We acquired the rights
to the license agreement with MD Anderson covering our WP1122 Portfolio held by IntertechBio Corporation, a company affiliated
with certain members of our management and board of directors. We acquired the rights to all data related to the development of
Annamycin held by AnnaMed, Inc., a company affiliated with certain members of our management and board of directors. Prior to the
effective date of the registration statement of which this prospectus is a part, Moleculin LLC will be merged with and into our
company. Moleculin LLC is affiliated with certain members of our management and board of directors. Prior to the effective date
of the registration statement of which this prospectus is a part, we will enter into an agreement with HPI whereby HPI will agree
to terminate its option to sublicense certain rights to the WP1066 Portfolio and to enter into a co-development agreement with
us. Waldemar Priebe and Don Picker are shareholders of HPI.
Securities and Exchange Commission
February 1, 2016
Page 4
None of the foregoing
transactions were conducted on an arm’s length basis. As such, it is possible that the terms we received were less favorable
than in an arm’s length transaction.”
“We face competition from other
biotechnology and pharmaceutical companies . . .,” page 18
6. Please amend your disclosure here and on page 51 to identify your likely principal competitors
and their products and/or product candidates that you believe may compete with your own products.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that it has add the following new paragraph as
the second paragraph to the referenced risk factor in the Registration Statement.
“A number of
attempts have been made or are under way to provide an improved treatment for AML. Drugs attempting to target a subset of AML patients
who present with particular anomalies involving a gene referred to as FLT3 are currently in clinical trials. Other approaches to
improve the effectiveness of induction therapy are in early stage clinical trials and, although they do not appear to address the
underlying problems with anthracyclines, we can provide no assurance that such improvements, if achieved, would not adversely impact
the need for improved anthracyclines. A modified version of doxorubicin designed to reduce cardiotoxicity is in clinical trials
for the treatment of sarcoma and, although this drug does not appear to address multidrug resistance and is not currently intended
for the treatment of acute leukemia, we can provide no assurance that it will not become a competitive alternative to Annamycin.
Although we are not aware of any other single agent therapies in clinical trials that would directly compete against Annamycin
in the treatment of relapsed and refractory AML, we can provide no assurance that such therapies are not in development, will not
receive regulatory approval and will reach market before our drug candidate Annamycin. In addition, any such competing therapy
may be more effective and / or cost-effective than ours.”
“Annamycin does not have composition of matter patent
protection,” page 18
7. Please revise the heading and body of this risk factor to clarify that Annamycin is not covered
by any existing patent protection, including composition of matter.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that it has made the requested revision to the
risk factor.
“The intellectual property rights
we have licensed from MD Anderson are subject to the rights of the U.S government,” page 18
Securities and Exchange Commission
February 1, 2016
Page 5
8. Please specify the basis for your belief that no funding agreements currently exist between
MD Anderson and the U.S. government that would impact your rights to the WP 1066 and WP1122 portfolios.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that the basis for the statement in the referenced
risk factor is that the existence of such an agreement was not disclosed to the Company in the course of confidential negotiations
leading to the license of the intellectual property from MD Anderson.
“Our acting chief executive officer
and our chief operating officer are currently working for us on a part-time basis ,” page 20
9. Please revise to provide the approximate number of weekly hours your CEO and COO devote to
your operations. Please also disclose whether you expect the CEO and the COO to continue to work part-time for you following the
IPO.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the referenced risk factor
as follows (emphasis added):
“Two of our key
employees are currently part-time and provide services for other biotechnology development efforts. Specifically, Walter Klemp,
our chairman and acting chief executive officer is also the chief executive officer of Soliton, Inc., a medical device development
company whose business operations we do not believe conflict with those of our company, and Donald Picker, our president and chief
operating officer, is currently also serving as chief operating officer of two other biotechnology companies, whose business operations
we do not believe conflict with those of our company. Both Messrs. Klemp and Picker currently provide services as needed
by us, which we estimate does not exceed 10 hours per week. Upon closing of this offering, Mr. Picker will become a full time officer
of our company and Mr. Klemp will continue to provide part time services to us as needed. As we progress, we will need
to identify a suitable CEO who can dedicate substantially full time to our company. We can provide no assurance that we will be
able to successfully identify and retain a qualified candidate for this position..”
Use of Proceeds, page 25
10. Please amend this disclosure to list the approximate percentage of offering proceeds you
intend to allocate toward each of the purposes listed in the second paragraph of this section. Please also indicate:
· The amount of funds you believe will be necessary to complete the Phase II clinical trial
for Annamycin and how far you expect to progress in the trial with the proceeds from this offering, assuming that the minimum,
and alternatively, maximum funds are received.
Securities and Exchange Commission
February 1, 2016
Page 6
· Please indicate the extent to which you contemplate using offering proceeds to pay down existing
debt or to satisfy other obligations, such your installment payments to MD Anderson for past due fees, discussed on page F-18.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that it has revised the Use of Proceeds as requested.
Capitalization, page 28
11. You state on page 8 that 6,661,000 shares of common stock to be outstanding after this offering
does not give effect to the [1],924,557 shares of common stock upon the conversion of $450,000 in principal amount of our outstanding
bridge notes, while you state here that such number gives effect to the conversion. Please resolve this discrepancy.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that the shares to be outstanding after this
offering will include 1) the 6,661,000 shares currently outstanding; 2) the shares issuable to holders of the convertible notes;
and 3) the shares issuable pursuant to the merger with Moleculin LLC and in connection with the Company’s agreement with
HPI. The Amended Registration Statement has been updated to resolve this discrepancy.
12. Please tell us why you did not reflect the following transaction in the number of shares
of common stock to be outstanding after this offering, given that these transactions have/would have occurred by the time the offering
closes:
· 629,000 shares issuable upon the execution of the HPI agreement; and
· The automatic conversion of $200,000 bridge notes issued after September 30, 2015.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that the Amended Registration Statement has been
updated to include shares issuable from both transactions in the shares of common stock to be outstanding after this offering.
Unaudited Pro Forma Combined Financial
Information
Note 2 – Preliminary purchase
price allocation, page 34
Securities and Exchange Commission
February 1, 2016
Page 7
13. Please disclose the method and the significant assumptions you will use to estimate the fair
value of the intangible assets you will acquire.
Response: The
Company acknowledges the Staff’s comment and respectfully advises the Staff that establishing a basis for allocating the
purchase price to the assets acquired and liabilities assumed at the date of acquisition would be done in accordance with FASB
ASC Topic 805, Business Combinations; FASB ASC Topic 350, Intangibles-Goodwill and Other and FASB ASC Topic 820, Fair
Value Measurements and Disclosures.
The Company anticipate the scope of the
analysis will include the following.
1. Developing estimates of fair value for the acquired tangible assets currently understood to include
leasehold improvements, equipment and furniture.
2. Developing fair value estimates of those identifiable intangible assets that meet the criteria
for identification separate from goodwill with measurable values and determinable lives, currently understood to include: license
agreements with MD Anderson and in-process research and development.
3. Developing estimates of economic lives for the amortizable, identifiable intangible assets.
4. Calculating the value of goodwill in accordance with FASB ASC Topic 805.
Premise of Value
The premise of value utilized in the Company’s
analysis will be fair value, which is defined by the FASB as “the price that would be received to sell an asset or paid
to transfer a liability in an orderly transaction between market participants at the measurement date.”
Valuation Approaches
The three traditional approaches employed
in determining the value of both tangible and intangible asse
2016-01-04 - UPLOAD - Moleculin Biotech, Inc.
Mail Stop 4720
December 31, 2015
Via E -mail
Walter Klemp
Chief Executive Officer
Moleculin Biotech, Inc.
2575 West Bellfort, Suite 333
Houston, Texas 77054
Re: Moleculin Biotech, Inc.
Draft Registration Statement on Form S -1
Submitted December 4, 2015
CIK No. 0001659617
Dear Mr. Klemp :
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 the 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 appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amende d draft registration statement or filed registration statement, we may have additional
comments.
Table of Contents , page i
1. You state you have not independently verified any of the market and industry data used
throughout your prospectus, and that the accuracy and completeness of such information
is not guaranteed. In order to eliminate any inference that you are not liable for all of the
information in your registration statement, please delete this statement or include a
statement specifically acknowledging your liability for information that appears in your
regis tration statement that was obtained from third party sources.
Walter Klemp
Molecul in Biotech, Inc.
December 31, 2015
Page 2
Prospectus Summary , page 1
2. Please explain, in layman’s terms, the meaning of “anthracycline.”
Risks Related to Our Business, page 3
3. Please include a bullet po int referencing the possibility of side effects in your product
candidates, noting that the most recent Phase I/II clinical trial of Annamycin caused two
fatalities due to tumor lysis , as stated on pages 2 and 16.
4. Please include a bullet point that addres ses your lack of product liability insurance for
your clinical trials.
Risk Factors , page 11
5. Please include a risk factor addressing the related -party nature of your pending merger
with Moleculin LLC. In particular, because of your affiliation with Moleculin , the
transaction by definition will not be conducted on an arm’s -length basis . This raises the
possibility , therefore, that the parties may agree on terms that are less favorable to the
company than in an arms -length negotiation .
“We face competition from other biotechnology and pharmaceutical companies . . .,” page 18
6. Pleas e amend your disclosure here and on page 51 to identify your likely principal
competitors and their products and/or product candidates that you believe may compete
with your own products.
“Annamycin does not have composition of matter patent protection,” page 18
7. Please revise the heading and body of this risk factor to clarify that Annamycin is not
covered by any e xisting patent protection, including composition of matter.
“The intellectual property rights we have licensed from MD Anderson are subject to the rights of
the U.S. government,” page 18
8. Please specify the basis for your belief that no funding agreements currently exist
between MD Anderson and the U.S. government that would impact your rights to the WP
1066 and WP11 22 portfolios.
“Our acting chief executive officer and our chief operating officer are currently working for us
on a part -time basis,” page 20
9. Please revise to provide the approximate number of weekly hours your CEO and COO
devote to your operations . Please also disclose whether you expect the CEO and the COO
to continue to work part -time for you following the IPO.
Walter Klemp
Molecul in Biotech, Inc.
December 31, 2015
Page 3
Use of Proceeds, page 25
10. Please amend this disclosure to list the approximate percentage of offering proceeds you
intend to allocate toward each of the purposes listed in the second paragraph of this
section. Please also indicate:
The amount of funds you believe will be nece ssary to complete the Phase II
clinical trial for Annamycin and how far you expect to progress in the trial
with the proceeds from this offering, assuming that the minimum, and
alternatively, maximum funds are received.
Please indicate the extent to whic h you contemplate using offering proceeds to
pay down existing debt or to satisfy other obligations , such your installment
payments to MD Anderson for past due fees, discussed on page F -18.
Capitalization, page 28
11. You state on page 8 that 6,661,000 shares of common stock to be outstanding after this
offering does not give effect to the [1],924,557 shares of common stock up on the
conversion of $450,000 in principal amount of our outstanding bridge notes, while you
state here that such number gives effect to the conversion. Please resolve this
discrepancy.
12. Please tell us why you did not reflect the following transaction in the number of shares of
common stock to be outstanding after this offering, given that these transactions
have/would have occurred by the time the offering closes:
629,000 shares issuable upon the execution of the HPI agreement ; and
The automatic conv ersion of $200,000 bridge notes issued after September 30,
2015.
Unaudited Pro Forma Combined Financial Information
Note 2 – Preliminary purchase price allocation, page 34
13. Please disclose the method and the significant assumptions you will use to estimat e the
fair value of the intangible assets you will acquire.
Note 3 – Pro Forma Adjustments, page 36
14. While you provide this pro forma information to reflect the acquisition of Moleculin, you
also adjust for some transactions that are triggered by the IPO. Tell us why it is
appropriate to reflect the conversion of convertible notes payable by MBI and the
repayment of notes payable by Moleculin, as well as eliminating associated interest
expense on the pro forma statements of operations.
Walter Klemp
Molecul in Biotech, Inc.
December 31, 2015
Page 4
15. Please revise to r eflect, if true, that the note explaining the pro forma adjustment for
Moleculin’s convertible notes payable and re lated interest are covered under note (h) with
the issuance of 1,000,000 MBI common shares, rather than under (f).
16. Refer to the note (i) of your pro forma adjustment note. Please tell us why you do not
reflect MD Anderson’s forfeiture to receive common unit s of Moleculin on your pro
forma combined balance sheet. Furthermore, explain why you show this liability as
assumed in the acquisition of Moleculin in your purchase price allocation table on page
35, when such liability no longer exists.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Significant Judgments and Estimates, page 38
17. Please describe how you estimate the fair value of your common stock underlying the
convertible notes payable. In addition, provide us an analysis explaining the reasons for
the differences between the recent valuations of your common stock leading up to the
IPO and the estimated offering price.
Components of our Results of Operations and Financial Condition, page 39
18. While MBI’s activities may have been limited since its incorporation, please provide a
discus sion for its results of operations and financial condition. For example, we believe
an explanation of expenses incurred to date will assist the investors in understanding your
activities to date. In addition, disclose the costs incurred during each perio d presented
and to date for each of your product candidates. If you do not maintain any research and
development costs by project, disclose that fact and explain why you do not maintain and
evaluate research and development costs by project and provide oth er quantitative or
qualitative disclosure that indicates the amount of your resources being used on each of
your projects.
Business , page 43
19. We note that Callisto Pharmaceuticals, Inc., a prior developer of Annamycin, decided to
suspend further development of Annamycin for acute leukemia on or before December
31, 2008. In its public filings, Callisto stated that the clinical data did not support further
clinical evaluation of Annamycin as a single agent treatment for relapsed or refractory
adult acute leukemia patients. Accordingly:
Please clarify in your disclosure whether the prior clinical trials you discuss
on page 45 were conducted by or on behalf of Callisto. If so, please explain:
o how it is possible to recon cile Callisto’s assessment of efficacy with your
statements that Annamycin demonstrated efficacy in those trials;
o how you are defining efficacy; and
Walter Klemp
Molecul in Biotech, Inc.
December 31, 2015
Page 5
o whether statistical significance was demonstrated in the trials you cite
Please also clarify how long it has been since the prior Phase I and Phase I/II
studies you cite were conducted and how long clinical development of
Annamycin for the treatment of adult relapsed or refractory acute leukemia
has been inactive.
Please provide the basis for your belief, stated on page 46, that prior drug
development activity was terminated for “financial” reasons.
Corporate History, page 43
20. Please provide a succinct discussion that clarifies the transactional history and common
relationships among Houston Pharmaceuticals, Inc., IntertechBio Corporation, Moleculin,
MBI, Callisto, AnnaMed, MD Anderson, and your officers and major shareholders.
21. Please discuss the terms of your agreement with AnnaMed to acquire the development
rights to Annamycin and provide the agreement as an exhibit to your draft registration
statement.
22. Please add section s in your disclosure that address:
your agreements with Houston Pharmaceuticals, Inc. , including disclosure of
the material terms regarding Houston Pharmaceutical’s termination of rights
to the WP1066 Portfolio and your ongoing negotiations regarding the co -
development agreement.
the terms of the merger between Moleculin and MBI .
Please also provide these agreements as exhibits to your draft registration statement to the
extent they have been executed.
Our License Agreements, page 50
23. Please disclose the extent of any legacy license obligations to which you are subject as a
result of your acquisition of the Annamycin development project from AnnaMed. If
there are license agreements associated with such obligations, please disclose the material
terms and provide these agreements as exhibits to your draft registration statement.
24. Please revise this section to disclose, for each license agreement, the amount of u pfront
payments, milestone payments, royalty rates and minimum royalties . We note your
disclosure of some of this information on pages F -10 and F -18. In addition, please
disclose the extent to which you are required to issue equity to MD Anderson upon the
occurrence of milestone e vents.
Walter Klemp
Molecul in Biotech, Inc.
December 31, 2015
Page 6
25. Please disclose the material terms of MD Anderson’s right to terminate each of the
license agreement s.
26. Please provide each license agreement with MD Anderson as an exhibit to your draft
registration statement.
27. Please describe the material terms of the Patent and Technology Development and
License Agreement with Dermin and provide this agreement as an exhi bit to your draft
registration statement.
Management, page 58
28. Please disclose Mr. K lemp’s business activities during the period prior to July 2015 and
following his time as CEO of Zeno Corporation.
Relationships and Related Party Transactions, page 63
29. In each case in this section where you have disclosed the existence of an affiliation
between an individual and an entity, p lease also disclose the specific nature of the
individual’s affiliation with the respective entity.
30. Please disclo se the shares of your common stock that Messrs. Priebe, Klemp and Picker
will each receive as a result of your merger with Moleculin.
Notes to Financial Statements
Note 1 – Description of business and Summary of Significant Accounting Policies
Nature of Business, page F -7
31. Please disclose the significant rights and obligations underlying the licenses relating to
Annamycin and WP 1122. Your obligations may include annual maintenance fees,
milestone payments, royalties, and minimum research expense requirements.
Note 7 – Subse quent Events, page F -9
32. Please t ell what you received in exchange for assuming IntertechBio Corporation’s
liability and why it is appropriate to classify related repayment as prepaid expenses.
Moleculin, LLC.
Audited Financial Statements
Statement of Cash Flo ws, page F -13
33. Please t ell us why you believe the $232,300 cash received from other receivable should
be classified as an operating activity.
Walter Klemp
Molecul in Biotech, Inc.
December 31, 2015
Page 7
Notes to Financial Statements
Note 1 – Description of Business and Summary of Significant Accounting Policies, page F -25
34. Please disclose how you account for the agreements under which you grant rights to your
technology in exchange for the licensee’s grant funding to pay for development costs.
Cite the relevant accounting literature to support your accounting.
Other Comm ents
35. Please suppl ement ally provide us with copies of all written communications, as defined
in Rule 405 und er the Securities Act, that you, or anyone authori zed to do so on your
behalf, present to po tential investors in reliance on Section 5(d) of the Securities Act,
whether or not they retain copies of the communications.
36. Please confirm that the graphics included in your registration statement are the only
graphics you will use in your prospectus. If those are not the only graphics, please
provide any a dditional graphics prior to their use for our review.
You may contact Keira Nakada at (202) 551 -3659 or Lisa Vanjoske at (202) 551 -3614 if
you have questions regarding comments on the financial statements and related matters. Please
contact Scot Foley at (202) 551 -3383, Daniel Greenspan at (202) 551 -3623 or me at (202) 551 -
3675 with any other questions.
Sincerely,
/s/ Daniel Greenspan for
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
cc: Cavas S. Pavri
Schiff Hardin LLP
100 N. 18th, Suite 300
Philadelphia, PA 19103