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Inhibikase Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
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Inhibikase Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2025-01-14
Inhibikase Therapeutics, Inc.
Summary
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Company responded
2025-01-14
Inhibikase Therapeutics, Inc.
Summary
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Inhibikase Therapeutics, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2024-12-03
Inhibikase Therapeutics, Inc.
Summary
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Inhibikase Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-06-21
Inhibikase Therapeutics, Inc.
Summary
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Company responded
2024-06-24
Inhibikase Therapeutics, Inc.
Summary
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Inhibikase Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-02-03
Inhibikase Therapeutics, Inc.
Summary
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Company responded
2023-02-03
Inhibikase Therapeutics, Inc.
Summary
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Inhibikase Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-02-09
Inhibikase Therapeutics, Inc.
Summary
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Company responded
2022-02-09
Inhibikase Therapeutics, Inc.
Summary
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Inhibikase Therapeutics, Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2021-06-03
Inhibikase Therapeutics, Inc.
Summary
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Company responded
2021-06-11
Inhibikase Therapeutics, Inc.
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Company responded
2021-06-11
Inhibikase Therapeutics, Inc.
Summary
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Inhibikase Therapeutics, Inc.
Response Received
13 company response(s)
High - file number match
SEC wrote to company
2020-08-14
Inhibikase Therapeutics, Inc.
Summary
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Company responded
2020-09-15
Inhibikase Therapeutics, Inc.
References: August 14, 2020
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2020-09-22
Inhibikase Therapeutics, Inc.
References: October 5, 2018
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Company responded
2020-09-29
Inhibikase Therapeutics, Inc.
References: September 23, 2020
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Company responded
2020-10-27
Inhibikase Therapeutics, Inc.
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Company responded
2020-10-27
Inhibikase Therapeutics, Inc.
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2020-10-30
Inhibikase Therapeutics, Inc.
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2020-10-30
Inhibikase Therapeutics, Inc.
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Company responded
2020-11-06
Inhibikase Therapeutics, Inc.
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Company responded
2020-11-06
Inhibikase Therapeutics, Inc.
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Company responded
2020-11-12
Inhibikase Therapeutics, Inc.
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2020-11-12
Inhibikase Therapeutics, Inc.
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Company responded
2020-12-17
Inhibikase Therapeutics, Inc.
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Company responded
2020-12-17
Inhibikase Therapeutics, Inc.
Summary
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Inhibikase Therapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2020-09-23
Inhibikase Therapeutics, Inc.
Summary
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Inhibikase Therapeutics, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2020-07-23
Inhibikase Therapeutics, Inc.
References: October 31, 2018
Summary
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Inhibikase Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2018-10-31
Inhibikase Therapeutics, Inc.
Summary
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Inhibikase Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2018-10-10
Inhibikase Therapeutics, Inc.
Summary
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Inhibikase Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2018-09-07
Inhibikase Therapeutics, Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-25 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-06-25 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | 333-288213 | Read Filing View |
| 2025-01-14 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | 333-284222 | Read Filing View |
| 2025-01-14 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-12-03 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-06-24 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-06-21 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | 333-280317 | Read Filing View |
| 2023-02-03 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-02-03 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-02-09 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-02-09 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-11 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-11 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-03 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-12-17 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-12-17 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-11-12 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-11-12 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-11-06 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-11-06 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-30 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-30 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-27 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-27 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-09-29 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-09-23 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-09-22 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-09-15 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-08-14 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-07-23 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-10-31 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-10-10 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-09-07 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-25 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | 333-288213 | Read Filing View |
| 2025-01-14 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | 333-284222 | Read Filing View |
| 2024-06-21 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | 333-280317 | Read Filing View |
| 2023-02-03 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-02-09 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-03 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-09-23 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-08-14 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-10-31 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-10-10 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-09-07 | SEC Comment Letter | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-25 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-01-14 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-12-03 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-06-24 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-02-03 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-02-09 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-11 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-11 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-12-17 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-12-17 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-11-12 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-11-12 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-11-06 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-11-06 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-30 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-30 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-27 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-27 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-09-29 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-09-22 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-09-15 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-07-23 | Company Response | Inhibikase Therapeutics, Inc. | DE | N/A | Read Filing View |
2025-06-25 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP VIA EDGAR June 25, 2025 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Re: Inhibikase Therapeutics, Inc. Acceleration Request for Registration Statement on Form S-3 Filed June 20, 2025 File No. 333-288213 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “ Act ”), Inhibikase Therapeutics, Inc. (the “ Company ”) hereby requests that the effective date of the above- referenced registration statement (the “ Registration Statement ”) be accelerated to June 27, 2025, at 4:01 pm Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our outside counsel, Goodwin Procter LLP, by calling Marishka DeToy at (617) 570-1926. If you have any questions regarding this request, please contact Marishka DeToy of Goodwin Procter LLP at (617) 570-1926. Sincerely, Inhibikase Therapeutics, Inc. /s/ David McIntyre David McIntyre Chief Financial Officer cc: Mark Iwicki, Inhibikase Therapeutics, Inc. Danielle Lauzon, Esq., Goodwin Procter LLP Marishka DeToy, Esq., Goodwin Procter LLP
2025-06-25 - UPLOAD - Inhibikase Therapeutics, Inc. File: 333-288213
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> June 25, 2025 Mark Iwicki Chief Executive Officer Inhibikase Therapeutics, Inc. 1000 N. West Street, Suite 1200 Wilmington, DE 19801 Re: Inhibikase Therapeutics, Inc. Registration Statement on Form S-3 Filed June 20, 2025 File No. 333-288213 Dear Mark Iwicki: 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 Joshua Gorsky at 202-551-7836 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Marishka DeToy </TEXT> </DOCUMENT>
2025-01-14 - UPLOAD - Inhibikase Therapeutics, Inc. File: 333-284222
January 14, 2025
Milton H. Werner
Chief Executive Officer
Inhibikase Therapeutics, Inc.
3350 Riverwood Parkway SE, Suite 1900
Atlanta, GA 30339
Re:Inhibikase Therapeutics, Inc.
Registration Statement on Form S-3
Filed January 10, 2025
File No. 333-284222
Dear Milton H. Werner:
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 Joshua Gorsky at 202-551-7836 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Marishka DeToy
2025-01-14 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Inhibikase Therapeutics, Inc. 3350 Riverwood Parkway SE, Suite 1900 Atlanta, GA 30339 January 14, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3720 Attention: Joshua Gorsky Re: Inhibikase Therapeutics, Inc. Registration Statement on Form S-3 Filed January 10, 2025 File No. 333-284222 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Inhibikase Therapeutics, Inc. (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on Form S-3 (File No. 333-284222) (the “Registration Statement”) be accelerated so that the Registration Statement will become effective on Thursday, January 16, 2025 at 4:30 p.m. (Eastern Time), or as soon thereafter as practicable. Please feel free to direct any questions or comments concerning this request to Marishka DeToy, Esq. of Goodwin Procter LLP at (617) 570-1926. The Company understands that the staff of the United States Securities and Exchange Commission will consider this request as confirmation by the Company that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. INHIBIKASE THERAPEUTICS, INC. By: /s/ Milton H. Werner, Ph.D. Name: Milton H. Werner, Ph.D. Title: President and Chief Executive Officer cc: Danielle Lauzon, Goodwin Procter LLP Marishka DeToy, Goodwin Procter LLP
2024-12-03 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Inhibikase Therapeutics, Inc. 3350 Riverwood Parkway SE, Suite 1900 Atlanta, GA 30339 December 3, 2024 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3720 Attention: Alan Campbell Re: Inhibikase Therapeutics, Inc. Registration Statement on Form S-3 Filed November 18, 2024 File No. 333-283307 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Inhibikase Therapeutics, Inc. (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on Form S-3 (File No. 333-283307) (the “Registration Statement”) be accelerated so that the Registration Statement will become effective on Thursday, December 5, 2024 at 4:30 p.m. (Eastern Time), or as soon thereafter as practicable. Please feel free to direct any questions or comments concerning this request to Todd Kornfeld, Esq. of McDermott Will & Emery LLP at (212) 547-5890. The Company understands that the staff of the United States Securities and Exchange Commission will consider this request as confirmation by the Company that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. INHIBIKASE THERAPEUTICS, INC. By: /S/ MILTON H. WERNER Name: Milton H. Werner, Ph.D. Title: President and Chief Executive Officer cc: Todd Kornfeld, McDermott Will & Emery LLP
2024-06-24 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Inhibikase Therapeutics, Inc. 3350 Riverwood Parkway SE, Suite 1900 Atlanta, GA 30339 June 24, 2024 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3720 Attention: Lauren Hamill Re: Inhibikase Therapeutics, Inc. Registration Statement on Form S-1 Filed June 18, 2024 File No. 333-280317 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Inhibikase Therapeutics, Inc. (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on Form S-1 (File No. 333-280317) (the “Registration Statement”) be accelerated so that the Registration Statement will become effective on Wednesday, June 26, 2024 at 5:00 p.m. (Eastern Time), or as soon thereafter as practicable. Please feel free to direct any questions or comments concerning this request to Todd Kornfeld, Esq. of McDermott Will & Emery LLP at (212) 547-5890. The Company understands that the staff of the United States Securities and Exchange Commission will consider this request as confirmation by the Company that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. INHIBIKASE THERAPEUTICS, INC. By: /S/ MILTON H. WERNER Name: Milton H. Werner, Ph.D. Title: President and Chief Executive Officer cc: Todd Kornfeld, McDermott Will & Emery LLP
2024-06-21 - UPLOAD - Inhibikase Therapeutics, Inc. File: 333-280317
United States securities and exchange commission logo
June 21, 2024
Milton Werner
Chief Executive Officer
Inhibikase Therapeutics, Inc.
3350 Riverwood Parkway SE, Suite 1900
Atlanta, GA 30339
Re:Inhibikase Therapeutics, Inc.
Registration Statement on Form S-1
Filed June 18, 2024
File No. 333-280317
Dear Milton Werner:
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 Lauren Hamill at 303-844-1008 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Todd Kornfeld
2023-02-03 - UPLOAD - Inhibikase Therapeutics, Inc.
United States securities and exchange commission logo
February 3, 2023
Milton Werner, Ph.D.
President and Chief Executive Officer
Inhibikase Therapeutics, Inc.
3350 Riverwood Parkway SE, Suite 1900
Atlanta, GA 30339
Re:Inhibikase Therapeutics, Inc.
Registration Statement on Form S-1
Filed February 2, 2023
File No. 333-269521
Dear Milton Werner:
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 Daniel Crawford at 202-551-7767 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Todd Kornfeld, Esq.
2023-02-03 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Inhibikase Therapeutics, Inc. 3350 Riverwood Parkway SE, Suite 1900 Atlanta, GA 30339 February 3, 2023 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Trade & Services 100 F Street, N.E. Washington, D.C. 20549-3720 Attention: Daniel Crawford Re: Inhibikase Therapeutics, Inc. Registration Statement on Form S-1 Filed February 2, 2023 File No. 333-269521 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Inhibikase Therapeutics, Inc. (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on Form S-1 (File No. 333-269521) (the “Registration Statement”) be accelerated so that the Company’s Registration Statement will become effective on Tuesday, February 7, 2023, at 3:00 p.m. (Eastern Time), or as soon thereafter as practicable. Please feel free to direct any questions or comments concerning this request to Merrill M. Kraines, Esq. at (212) 547-5616 or Todd Kornfeld, Esq. at (212) 547-5890 of McDermott Will & Emery LLP. The Company understands that the staff of the United States Securities and Exchange Commission will consider this request as confirmation by the Company that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement. INHIBIKASE THERAPEUTICS, INC. By: /s/ Milton H. Werner Name: Milton H. Werner, Ph.D. Title: President and Chief Executive Officer cc: Merrill M. Kraines, McDermott Will & Emery LLP Todd Kornfeld, McDermott Will & Emery LLP
2022-02-09 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Inhibikase Therapeutics, Inc. 3350 Riverwood Parkway SE, Suite 1900 Atlanta, GA 30339 February 9, 2022 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attn: Jordan Nimitz Re: Inhibikase Therapeutics, Inc. Registration Statement on Form S-3 SEC File No. 333-262551 Filed February 4, 2022 Ladies and Gentlemen: Pursuant to Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, Inhibikase Therapeutics, Inc. (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on Form S-3 (File No. 333-262551) (the “Registration Statement”) be accelerated so that the Company’s Registration Statement will become effective at 5:00 PM, eastern standard time, on February 11, 2022, or as soon thereafter as is practicable, or at such other time thereafter as our counsel, Troutman Pepper Hamilton Sanders LLP, may request by telephone. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Troutman Pepper Hamilton Sanders LLP, by calling Merrill M. Kraines at (212) 808-2711. INHIBIKASE THERAPEUTICS, INC. By: /s/ Milton H. Werner, Ph.D. Milton H. Werner, Ph.D. President and Chief Executive Officer Cc: Merrill M. Kraines, Troutman Pepper Hamilton Sanders LLP
2022-02-09 - UPLOAD - Inhibikase Therapeutics, Inc.
United States securities and exchange commission logo
February 9, 2022
Milton H. Werner
President and Chief Executive Officer
Inhibikase Therapeutics, Inc.
3350 Riverwood Parkway SE, Suite 1900
Atlanta, GA 30339
Re:Inhibikase Therapeutics, Inc.
Registration Statement on Form S-3
Filed February 7, 2022
File No. 333-262551
Dear Dr. Werner:
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 Jordan Nimitz at 202-551-5831 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-06-11 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP
1
filename1.htm
CORRESP
ThinkEquity,
A Division of Fordham Financial Management, Inc
17 State Street, 22nd Floor
New York, New York 10004
June 11, 2021
VIA EDGAR
United States Securities and Exchange Commission
Division of
Corporation Finance
100 F Street, N.E.
Washington, D.C.
20549
Re:
Inhibikase Therapeutics, Inc. (the “Company”)
Registration Statement on Form S-1
Ladies and Gentlemen:
Pursuant to Rule 461 of the General Rules and Regulations of the United States Securities and Exchange Commission under the Securities Act of
1933, as amended (the “Securities Act”), ThinkEquity, a division of Fordham Financial Management, Inc., as representative of the underwriters of the offering, hereby joins the request of the Company that the effective date of the
Company’s Registration Statement on Form S-1 filed on the date hereof be accelerated so as to permit it to become effective on Tuesday, June 15, 2021, at 5:00
p.m. (Eastern Time), or as soon thereafter as practicable.
Pursuant to Rule 460 of the General Rules and Regulations of the
Securities Act, please be advised that there will be distributed to each underwriter or dealer, who is reasonably anticipated to be invited to participate in the distribution of the securities, as many copies, as well as “E-red” copies of the preliminary prospectus, as appears to be reasonable to secure adequate distribution of the preliminary prospectus.
The undersigned confirms that it has complied with and will continue to comply with, and it has been informed or will be informed by
participating dealers that they have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue.
Very truly yours,
ThinkEquity,
a division of Fordham Financial Management, Inc.
By:
/s/ Eric Lord
Name:
Eric Lord
Title:
Head of Investment Banking
cc:
Leslie Marlow, Esq.
Patrick J. Egan,
Esq.
2021-06-11 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP
1
filename1.htm
CORRESP
Inhibikase Therapeutics, Inc.
3350 Riverwood Parkway, Suite 1900
Atlanta, GA 30339
June 11,
2021
VIA EDGAR
United States Securities and
Exchange Commission
Division of Corporation Finance
Office
of Life Sciences
100 F Street, N.E.
Washington, D.C.
20549-3720
Attention: David Gessert
Re:
Inhibikase Therapeutics, Inc.
Registration Statement on Form S-1
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, Inhibikase Therapeutics, Inc. (the “Company”) hereby
requests that the effective date of the Company’s Registration Statement on Form S-1 filed on the date hereof (the “Registration Statement”) be accelerated so that the Company’s
Registration Statement will become effective on Tuesday, June 15, 2021, at 5:00 p.m. (Eastern Time), or as soon thereafter as practicable.
Please feel free to direct any questions or comments concerning this request to Merrill M. Kraines, Esq. of Troutman Pepper Hamilton Sanders
LLP at (212) 808-2711.
The Company understands that the staff of the United States Securities and
Exchange Commission will consider this request as confirmation by the Company that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement.
INHIBIKASE THERAPEUTICS, INC.
By:
/s/ Milton H. Werner, Ph.D.
Name: Milton H. Werner, Ph.D.
Title: President and Chief Executive Officer
cc: Merrill M. Kraines, Esq., Troutman Pepper Hamilton Sanders LLP
2021-06-03 - UPLOAD - Inhibikase Therapeutics, Inc.
United States securities and exchange commission logo
June 3, 2021
Milton H. Werner, Ph.D.
President and Chief Executive Officer
Inhibikase Therapeutics, Inc.
3350 Riverwood Parkway SE, Suite 1900
Atlanta, GA 30339
Re:Inhibikase Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted June 2, 2021
CIK No. 0001750149
Dear Dr. Werner:
This is to advise you that we do not intend to review your registration statement.
We request that you publicly file your registration statement no later than 48 hours prior
to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for
acceleration. We remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
Please contact David Gessert at 202-551-2326 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2020-12-17 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP
1
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ThinkEquity,
A Division of Fordham Financial Management,
Inc
17 State Street, 22nd Floor
New York, New York 10004
December 17, 2020
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Inhibikase Therapeutics, Inc. (the “Company”)
Registration Statement on Form S-1, as amended (the “Registration
Statement”)
File No. 333-240036
Ladies and Gentlemen:
Pursuant to Rule
461 of the General Rules and Regulations of the United States Securities and Exchange Commission under the Securities Act of
1933, as amended (the “Securities Act”), ThinkEquity, a division of Fordham Financial Management, Inc., as
representative of the underwriters of the offering, hereby joins the request of the Company that the effective date of the
above-referenced Registration Statement on Form S-1 be accelerated so as to permit it to become effective on Monday,
December 21, 2020, at 5:00 p.m. (Eastern Time), or as soon thereafter as practicable.
Pursuant to Rule 460
of the General Rules and Regulations of the Securities Act, please be advised that there will be distributed to each underwriter
or dealer, who is reasonably anticipated to be invited to participate in the distribution of the securities, as many copies, as
well as “E-red” copies of the preliminary prospectus, as appears to be reasonable to secure adequate distribution of
the preliminary prospectus.
The undersigned confirms
that it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers
that they have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended,
in connection with the above-referenced issue.
Very truly yours,
ThinkEquity,
a division of Fordham Financial Management, Inc.
By:
/s/ Eric Lord
Name:
Eric Lord
Title:
Head of Investment Banking
cc: Leslie Marlow, Esq.
Patrick J. Egan, Esq.
2020-12-17 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP
1
filename1.htm
Inhibikase Therapeutics, Inc.
3350 Riverwood Parkway, Suite 1900
Atlanta, GA 30339
December 17, 2020
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549-3720
Attention: Rolf Sundwall
Sasha Parikh
Abby Adams
Suzanne Hayes
Re: Inhibikase Therapeutics,
Inc.
Registration Statement on Form S-1
SEC File No. 333-240036
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities
Act of 1933, as amended, Inhibikase Therapeutics, Inc. (the “Company”) hereby requests that the effective date
of the Company’s Registration Statement on Form S-1 (File No. 333-240036) (the “Registration Statement”)
be accelerated so that the Company’s Registration Statement will become effective on Monday, December 21, 2020, at 5:00
p.m. (Eastern Time), or as soon thereafter as practicable.
Please feel free to direct any questions or
comments concerning this request to Merrill M. Kraines, Esq. of Troutman Pepper Hamilton Sanders LLP at (212) 808-2711.
The Company understands that the staff of
the United States Securities and Exchange Commission will consider this request as confirmation by the Company that it is aware
of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration
Statement.
Inhibikase Therapeutics, Inc.
By:
/s/ Milton H. Werner, Ph.D.
Name: Milton H. Werner, Ph.D.
Title: President, Chief Executive Officer
Cc: Merrill M. Kraines, Troutman Pepper Hamilton Sanders
LLP
2020-11-12 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP
1
filename1.htm
Inhibikase Therapeutics, Inc.
3350 Riverwood Parkway, Suite 1900
Atlanta, GA 30339
November 12, 2020
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549-3720
Attention: Rolf Sundwall
Sasha Parikh
Abby Adams
Suzanne Hayes
Re: Inhibikase Therapeutics,
Inc.
Registration Statement on Form S-1
SEC File No. 333-240036
Ladies and Gentlemen:
Reference is made to that certain letter,
filed as correspondence via EDGAR on November 6, 2020, in which Inhibikase Therapeutics, Inc. (the “Company”)
requested that the effective date of the Company’s Registration Statement on Form S-1 (File No. 333-240036) (the “Registration
Statement”) be accelerated so that the Company’s Registration Statement would become effective on Tuesday, November
10, 2020, at 5:00 p.m. (Eastern Time), or as soon thereafter as practicable. The undersigned, on behalf of the Company, is no longer
requesting that the Registration Statement become effective at this time and hereby formally withdraws such request.
Inhibikase Therapeutics, Inc.
By:
/s/ Milton H. Werner, Ph.D.
Name: Milton H. Werner, Ph.D.
Title: President, Chief Executive Officer
Cc: Merrill M. Kraines, Troutman Pepper Hamilton Sanders LLP
2020-11-12 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP
1
filename1.htm
ThinkEquity,
A Division of Fordham Financial Management,
Inc
17 State Street, 22nd Floor
New York, New York 10004
November 12, 2020
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Inhibikase Therapeutics, Inc. (the “Company”)
Registration Statement on Form S-1, as amended (the “Registration
Statement”)
File No. 333-240036
Ladies and Gentlemen:
On November 6, 2020,
ThinkEquity, a division of Fordham Financial Management, Inc. (“ThinkEquity”), as representative of the underwriters
of the offering, joined in the request of the Company that the effective date of the above-referenced Registration Statement on
Form S-1 be accelerated so as to permit it to become effective on Tuesday, November 10, 2020, at 5:00 p.m. (Eastern Time),
or as soon thereafter as practicable. The undersigned, on behalf of ThinkEquity, hereby withdraws such request.
Very truly yours,
ThinkEquity,
a division of Fordham Financial Management, Inc.
By:
/s/ Eric Lord
Name:
Eric Lord
Title:
Head of Investment Banking
cc: Leslie Marlow, Esq.
Patrick J. Egan, Esq.
2020-11-06 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP
1
filename1.htm
Inhibikase Therapeutics, Inc.
3350 Riverwood Parkway, Suite 1900
Atlanta, GA 30339
November 6, 2020
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549-3720
Attention: Rolf Sundwall
Sasha Parikh
Abby Adams
Suzanne Hayes
Re: Inhibikase Therapeutics,
Inc.
Registration Statement on Form S-1
SEC File No. 333-240036
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities
Act of 1933, as amended, Inhibikase Therapeutics, Inc. (the “Company”) hereby requests that the effective date
of the Company’s Registration Statement on Form S-1 (File No. 333-240036) (the “Registration Statement”)
be accelerated so that the Company’s Registration Statement will become effective on Tuesday, November 10, 2020, at 5:00
p.m. (Eastern Time), or as soon thereafter as practicable.
Please feel free to direct any questions or
comments concerning this request to Merrill M. Kraines, Esq. of Troutman Pepper Hamilton Sanders LLP at (212) 808-2711.
The Company understands that the staff of
the United States Securities and Exchange Commission will consider this request as confirmation by the Company that it is aware
of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration
Statement.
Inhibikase Therapeutics, Inc.
By:
/s/ Milton H. Werner, Ph.D.
Name: Milton H. Werner, Ph.D.
Title: President, Chief Executive Officer
Cc: Merrill M. Kraines, Troutman Pepper Hamilton Sanders
LLP
2020-11-06 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP
1
filename1.htm
ThinkEquity,
A Division of Fordham Financial Management,
Inc
17 State Street, 22nd Floor
New York, New York 10004
November 6, 2020
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Inhibikase Therapeutics, Inc. (the “Company”)
Registration Statement on Form S-1, as amended (the “Registration
Statement”)
File No. 333-240036
Ladies and Gentlemen:
Pursuant to Rule 461
of the General Rules and Regulations of the United States Securities and Exchange Commission under the Securities Act of 1933,
as amended (the “Securities Act”), ThinkEquity, a division of Fordham Financial Management, Inc., as representative
of the underwriters of the offering, hereby joins the request of the Company that the effective date of the above-referenced Registration
Statement on Form S-1 be accelerated so as to permit it to become effective on Tuesday, November 10, 2020, at 5:00 p.m. (Eastern
Time), or as soon thereafter as practicable.
Pursuant to Rule 460
of the General Rules and Regulations of the Securities Act, please be advised that there will be distributed to each underwriter
or dealer, who is reasonably anticipated to be invited to participate in the distribution of the securities, as many copies, as
well as “E-red” copies of the preliminary prospectus, as appears to be reasonable to secure adequate distribution of
the preliminary prospectus.
The undersigned confirms
that it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers
that they have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended,
in connection with the above-referenced issue.
Very truly yours,
ThinkEquity,
a division of Fordham Financial Management, Inc.
By:
/s/ Eric Lord
Name:
Eric Lord
Title:
Head of Investment Banking
cc: Leslie Marlow, Esq.
Patrick J. Egan, Esq.
2020-10-30 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP
1
filename1.htm
ThinkEquity,
A Division of Fordham Financial Management,
Inc
17 State Street, 22nd Floor
New York, New York 10004
October 30, 2020
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Inhibikase Therapeutics, Inc. (the “Company”)
Registration Statement on Form S-1, as amended (the “Registration
Statement”)
File No. 333-240036
Ladies and Gentlemen:
On October 27, 2020,
ThinkEquity, a division of Fordham Financial Management, Inc. (“ThinkEquity”), as representative of the underwriters
of the offering, joined in the request of the Company that the effective date of the above-referenced Registration Statement on
Form S-1 be accelerated so as to permit it to become effective on Thursday, October 29, 2020, at 5:00 p.m. (Eastern Time),
or as soon thereafter as practicable. The undersigned, on behalf of ThinkEquity, hereby withdraws such request.
Very truly yours,
ThinkEquity,
a division of Fordham Financial Management, Inc.
By:
/s/ Eric Lord
Name:
Eric Lord
Title:
Head of Investment Banking
cc: Leslie Marlow, Esq.
Patrick J. Egan, Esq.
2020-10-30 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP
1
filename1.htm
Inhibikase Therapeutics, Inc.
3350 Riverwood Parkway, Suite 1900
Atlanta, GA 30339
October 30, 2020
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549-3720
Attention: Rolf Sundwall
Sasha
Parikh
Abby
Adams
Suzanne
Hayes
Re: Inhibikase Therapeutics,
Inc.
Registration Statement on Form S-1
SEC File No. 333-240036
Ladies and Gentlemen:
Reference
is made to that certain letter, filed as correspondence via EDGAR on October 27, 2020, in which Inhibikase Therapeutics, Inc.
(the “Company”) requested that the effective date of the Company’s Registration Statement on Form S-1
(File No. 333-240036) (the “Registration Statement”) be accelerated so that the Company’s Registration
Statement would become effective on Thursday, October 29, 2020, at 5:00 p.m. (Eastern Time), or as soon thereafter as practicable.
The undersigned is no longer requesting that the Registration Statement become effective at this time and hereby formally withdraws
such request.
Inhibikase Therapeutics, Inc.
By:
/s/ Milton H. Werner, Ph.D.
Name: Milton H. Werner, Ph.D.
Title: President, Chief Executive Officer
Cc: Merrill M. Kraines, Troutman Pepper Hamilton Sanders LLP
2020-10-27 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP
1
filename1.htm
ThinkEquity,
A Division of Fordham Financial Management,
Inc
17 State Street, 22nd Floor
New York, New York 10004
October 27, 2020
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Inhibikase Therapeutics, Inc. (the “Company”)
Registration Statement on Form S-1, as amended (the “Registration
Statement”)
File No. 333-240036
Ladies and Gentlemen:
Pursuant to Rule 461
of the General Rules and Regulations of the United States Securities and Exchange Commission under the Securities Act of 1933,
as amended (the “Securities Act”), ThinkEquity, a division of Fordham Financial Management, Inc., as representative
of the underwriters of the offering, hereby joins the request of the Company that the effective date of the above-referenced Registration
Statement on Form S-1 be accelerated so as to permit it to become effective on Thursday, October 29, 2020, at 5:00 p.m. (Eastern
Time), or as soon thereafter as practicable.
Pursuant to Rule 460
of the General Rules and Regulations of the Securities Act, please be advised that there will be distributed to each underwriter
or dealer, who is reasonably anticipated to be invited to participate in the distribution of the securities, as many copies, as
well as “E-red” copies of the preliminary prospectus, as appears to be reasonable to secure adequate distribution of
the preliminary prospectus.
The undersigned confirms
that it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers
that they have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended,
in connection with the above-referenced issue.
Very truly yours,
ThinkEquity,
a division of Fordham Financial Management, Inc.
By:
/s/ Eric Lord
Name:
Eric Lord
Title:
Head of Investment Banking
cc: Leslie Marlow, Esq.
Patrick J. Egan, Esq.
2020-10-27 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP
1
filename1.htm
Inhibikase Therapeutics, Inc.
3350 Riverwood Parkway, Suite 1900
Atlanta, GA 30339
October 27, 2020
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549-3720
Attention: Rolf Sundwall
Sasha Parikh
Abby Adams
Suzanne Hayes
Re: Inhibikase Therapeutics,
Inc.
Registration Statement on Form S-1
SEC File No. 333-240036
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities
Act of 1933, as amended, Inhibikase Therapeutics, Inc. (the “Company”) hereby requests that the effective date
of the Company’s Registration Statement on Form S-1 (File No. 333-240036) (the “Registration Statement”)
be accelerated so that the Company’s Registration Statement will become effective on Thursday, October 29, 2020, at 5:00
p.m. (Eastern Time), or as soon thereafter as practicable.
Please feel free to direct any questions or
comments concerning this request to Merrill M. Kraines, Esq. of Troutman Pepper Hamilton Sanders LLP at (212) 808-2711.
The Company understands that the staff of
the United States Securities and Exchange Commission will consider this request as confirmation by the Company that it is aware
of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration
Statement.
Inhibikase Therapeutics, Inc.
By:
/s/ Milton H. Werner, Ph.D.
Name: Milton H. Werner, Ph.D.
Title: President, Chief Executive Officer
Cc: Merrill M. Kraines, Troutman Pepper Hamilton Sanders LLP
2020-09-29 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP
1
filename1.htm
Troutman Pepper Hamilton Sanders LLP
620 Eighth Avenue, 37th Floor
New York, NY 10018
troutman.com
September 29, 2020
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549-3720
Attention: Rolf Sundwall
Sasha Parikh
Abby Adams
Suzanne Hayes
Re: Inhibikase Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed September 15, 2020
File No. 333-240036
Ladies and Gentlemen:
On behalf of our client,
Inhibikase Therapeutics, Inc. (“Inhibikase” or the “Company”), we submit this letter in response
to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
contained in its letter dated September 23, 2020 (the “Comment Letter”), relating to the above referenced Registration
Statement on Form S-1 (the “Registration Statement”). We are concurrently submitting via EDGAR this letter and
filing the revised Registration Statement.
In this letter, we
have recited the comments from the Staff in italicized, bold type and have followed each comment with the Company’s response.
Except for the page references contained in the comments of the Staff, or as otherwise specifically indicated, page references
herein correspond to the page of the revised the Registration Statement.
Amendment No.
1 to Form S-1 filed September 15, 2020
Inside Cover
Page, page i
1. We note your response to comment 2, and expanded disclosure regarding the nature of Dementia
with Lewy Body and animal studies for Multiple System Atrophy and Progressive Multifocal Leukoencephalopathy. Please provide further
support for you belief that your research program for Dementia with Lewy Body is material as it currently appears you have not
begun research in this area. Additionally, revise your business section to describe the material terms of your collaborative arrangements
with Rush University and Louisiana State University. Please file these agreements as exhibits or provide us with an analysis supporting
your determination that you are not dependent on them.
September 29, 2020
Page 2
The Company respectfully advises the Staff that it
has revised the disclosure on page 111 of the Registration Statement to explain that Parkinson’s Disease and Dementia with
Lewy Bodies (“DLB”) are both Lewy Body disorders and to further explain our strategy with respect to DLB. We
further revised the disclosure to indicate that “[t]he development of an animal model to assess the therapeutic utility
in DLB is not necessary because we believe the characteristics of a molecule suitable for treatment of DLB are similar to one
used to treat PD given the significant overlap in disease pathology and clinical features. Rather, we are evaluating which
of the 148x series molecules is the best candidate to follow IkT-148009 into the clinic and planning the IND-enabling studies
required to evaluate the molecule clinically in patients with a formal diagnosis of DLB.”
To
address the second point, the Company respectfully advises the Staff that it has revised the business section on pages 119 and
120 of the Registration Statement to describe the material terms of its current collaborative arrangements with Rush University
and Louisiana State University. The Company is not dependent on such collaborative arrangements as they are not related to its
current lead product candidates.
Prospectus Summary
Overview, page 1
2. We note your response to comment 5; however, the statement, “We believe IkT-001Pro
will improve patient experience and treatment compliance and could become the standard of-care as a result” remains on page
95. Please revise to eliminate the implication that your product will be effective.
The
Company respectfully advises the Staff that it has removed the disclosure on page 96 of the Registration Statement to
eliminate the implication that its product will be effective.
Management’s Discussion
and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies
and Significant Judgments and Estimates
Stock-Based Compensation, page
92
3. Please revise your disclosure to quantify the stock compensation expense for both of the
warrants issued August 25, 2020 in the aggregate as well as the amount that will be recognized in your September 30, 2020 financial
statements.
The
Company respectfully advises the Staff that it has revised the disclosure on pages 92-93, F-23 and F-35-36 of the Registration
Statement to quantify the estimated stock compensation expense for both of the warrants issued August 25, 2020 in the aggregate
as well as the amount that will be recognized in its September 30, 2020 financial statements.
In
order to facilitate the Staff’s review of the Registration Statement, the Company is providing the following chronology:
On
December 31, 2019, the Board of Directors (“Board”) of the Company adopted
certain resolutions (“December 31, 2019 Resolutions”) approving a grant of
25,000 non-qualified options to the Company’s contracted CFO, Joseph Frattaroli, effective January 1, 2020, expiring seven
years from the grant date, and vesting over 24 months (“December 31, 2019 Award”).
The December 31, 2019 Resolutions did not specifically approve the exercise price of the December 31, 2019 Award.
September 29, 2020
Page 3
On
July 24, 2020, in anticipation of an award grant to Mr. Frattaroli, the Company obtained a valuation from Dahn Consulting Group,
an independent valuation firm (“Dahn”), valuing the fair market value of the
Company’s common stock at $5.16 per share as of July 24, 2020 (“July 24, 2020 Valuation Price”).
On
August 6, 2020, the Board and the stockholders of the Company approved an amendment to the Company’s Certificate of Incorporation
to effect a 1-for-1.14396 reverse-stock-split of the issued and outstanding common stock of the Company, with those stockholders
otherwise entitled to receive a fractional share receiving one whole share in lieu of such fractional share, to be effective as
of August 10, 2020 (“Initial Reverse Stock Split”).
On
August 10, 2020, the Board adopted certain resolutions (“August 10, 2020 Resolutions”)
approving an issuance to Mr. Frattaroli of warrants to purchase 150,000 shares of the Company’s common stock with an exercise
price equal to the July 24, 2020 Valuation Price, as adjusted for the Initial Reverse Stock Split, or $5.90 per share. The August
10, 2020 Resolutions did not address adjustment of the number of shares subject to the warrant for the then-contemplated Initial
Reverse Stock Split. Such warrants would vest in full upon the first anniversary of the grant date, and expire seven years from
the grant date (“August 10, 2020 Award”).
On
August 19, 2020, the Company and the representative of the underwriters, ThinkEquity, a division of Fordham Financial Management,
Inc., agreed upon a preliminary pricing range for the Company’s initial public offering of between $10 and $12 per share
of the Company’s common stock. Such preliminary price range was reflected in the Registration Statement filed with the Securities
and Exchange Commission on September 15, 2020.
On
August 20, 2020, the Board approved a Certificate of Correction and a Certificate of Amendment to the Certificate of Incorporation
withdrawing the Certificate of Amendment previously approved by the Board on August 6, 2020 and filed with the Delaware Secretary
of State on August 10, 2020. As a result, the Initial Reverse Stock Split was deemed null and void and the new Certificate of Amendment
was filed on August 21, 2020 to effect a 1-for-1.14396 reverse-stock-split of the issued and issued and outstanding common stock
of the Company effective as of August 24, 2020 (“Reverse Stock Split”). Stockholders
otherwise entitled to receive a fractional share as a result of the Reverse Stock Split would now receive a cash payout rather
than one whole share of common stock of the Company.
As
of August 24, 2020, neither the December 31, 2019 Award nor the August 10, 2020 Award had been issued upon the terms approved by
the Board.
September 29, 2020
Page 4
On
August 25, 2020, the Board adopted certain resolutions (“August 25, 2020 Resolutions”)
(i) replacing and superseding the December 31, 2019 Resolutions and the August 10, 2020 Resolutions in their entirety and (ii)
approving the terms and conditions of the December 31, 2019 Award and the August 10, 2020 Award in the forms attached thereto.
The December 31, 2019 Resolutions and the August 10, 2020 Resolutions contained certain inconsistencies and inaccuracies in the
approval of the December 31, 2019 Award and the August 10, 2020 Award, including the type of award (options vs. warrants), the
name of the holder (Mr. Frattaroli individually vs. Flagship Consulting, Inc., Mr. Frattaroli’s consulting firm) and the
vesting schedule (in the case of the December 31, 2019 Award, fully vested vs. vesting over 24 months). Such warrants issued to
Flagship Consulting, Inc. were approved by the Board, dated as of, and granted to Flagship Consulting, Inc. on August 25, 2020.
The
December 31, 2019 Award and the August 10, 2020 Award were approved and granted on August 25, 2020 in accordance with the terms
and conditions of the August 25, 2020 Resolutions and the forms of warrants attached thereto, consistent with the issue date on
the face of the executed warrants.
On
September 24, 2020, the Company obtained a valuation from Dahn valuing the fair market value of Company’s common stock at
$5.87 per share, determined as of August 25, 2020, which was nearly identical to the July 24, 2020 Valuation Price as adjusted
for the Reverse Stock Split. The December 31, 2019 Award and the August 10, 2020 Award to Flagship Consulting, Inc. were granted
on August 25, 2020 at $5.90 per share.
* * *
We hope that the foregoing
has been responsive to the Staff’s comments. Please direct any questions with respect to this submission to me at (212) 808-2711
or merrill.kraines@troutman.com.
Sincerely,
/s/ Merrill M. Kraines
Merrill M. Kraines, Esq.
cc: Milton H. Werner, Ph.D., Inhibikase Therapeutics, Inc.
Todd Kornfeld, Esq., Troutman Pepper Hamilton Sanders LLP
Leslie Marlow, Esq., Gracin & Marlow
LLP
2020-09-23 - UPLOAD - Inhibikase Therapeutics, Inc.
United States securities and exchange commission logo
September 23, 2020
Milton H. Werner
President and Chief Executive Officer
Inhibikase Therapeutics, Inc.
3350 Riverwood Parkway SE, Suite 1927
Atlanta, GA 30339
Re:Inhibikase Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed September 15, 2020
File No. 333-240036
Dear Dr. Werner:
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 August 14, 2020 letter.
Amendment No. 1 to Form S-1 filed September 15, 2020
Inside Cover Page, page i
1.We note your response to comment 2, and expanded disclosure regarding the nature of
Dementia with Lewy Body and animal studies for Multiple System Atrophy and
Progressive Multifocal Leukoencephalopathy. Please provide further support for you
belief that your research program for Dementia with Lewy Body is material as it currently
appears you have not begun research in this area. Additionally, revise your business
section to describe the material terms of your collaborative arrangements with Rush
University and Louisiana State University. Please file these agreements as exhibits or
provide us with an analysis supporting your determination that you are not dependent on
them.
FirstName LastNameMilton H. Werner
Comapany NameInhibikase Therapeutics, Inc.
September 23, 2020 Page 2
FirstName LastName
Milton H. Werner
Inhibikase Therapeutics, Inc.
September 23, 2020
Page 2
Prospectus Summary
Overview, page 1
2.We note your response to comment 5; however, the statement, "We believe IkT-001Pro
will improve patient experience and treatment compliance and could become the standard-
of-care as a result" remains on page 95. Please revise to eliminate the implication that
your product will be effective.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Significant Judgments and Estimates
Stock-Based Compensation, page 92
3.Please revise your disclosure to quantify the stock compensation expense for both of the
warrants issued August 25, 2020 in the aggregate as well as the amount that will be
recognized in your September 30, 2020 financial statements.
You may contact Rolf Sundwall at (202) 551-3105 or Sasha Parikh at (202) 551-3627 if
you have questions regarding comments on the financial statements and related matters. Please
contact Abby Adams at (202) 551-6902 or Suzanne Hayes at (202) 551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Merrill M. Kraines, Esq.
2020-09-22 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP
1
filename1.htm
Troutman Pepper Hamilton Sanders LLP
620 Eighth Avenue, 37th Floor
New York, NY 10018
troutman.com
September 22, 2020
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549-3720
Attention: Rolf Sundwall
Sasha Parikh
Abby Adams
Suzanne Hayes
Re: Inhibikase Therapeutics, Inc.
Registration Statement on Form
S-1
File No. 333-240036
Ladies and Gentlemen:
On behalf of our client, Inhibikase Therapeutics, Inc.
(the “Company”), we submit this letter in response to a comment from the staff (the
“Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its
letter dated October 5, 2018, relating to the the Company’s Draft Registration Statement on Form S-1 confidentially submitted
to the Commission on August 31, 2018 and amended on October 16, 2018, which was subsequently updated by the Company with a
Registration Statement on Form S-1 filed with the Commission on July 23, 2020 and amended on September 15, 2020 (the
“Registration Statement”).
In this response letter, we have recited the comment 9 from
the Staff in italicized, bold type and have followed such comment with the Company’s response.
Stock-Based Compensation, page 84
9. Once you
have an estimated offering price or range, please explain to us how you determined the fair value of the common stock underlying
your equity issuances and the reasons for any differences between the recent valuations of your common stock leading up to the
IPO and the estimated offering price. This information will help facilitate our review of your accounting for equity issuances
including stock compensation and beneficial conversion features.
The Company respectfully submits the below additional information
to assist the Staff in its review of the Company’s determination of the fair value of its common stock underlying its equity
issuances and the reasons for the differences between the recent valuations of its common stock and the estimated offering price
for its proposed initial public offering (“IPO”).
Preliminary IPO Price Range
The Preliminary Price Range (as defined below) has been estimated based on a number of factors, including the progress of the Company’s
studies and trials, other developments in the Company’s business, current market conditions and market
data from representative of the underwriters that has been presented to and reviewed by the Company’s board of directors
(the “Board”) and management during August and September 2020. As is typical for initial public offerings, the Preliminary Price Range was not derived using a formal determination of fair value, but
was determined as a result of discussions among representatives of the Company and the representative of the underwriters. During these
discussions, the parties considered quantitative factors, as well as non-quantitative factors, such as the valuations of recently completed
public offerings and evaluating those issuers’ respective stages of development as compared to the Company, the current valuations
of public companies at a similar stage of clinical development as the Company taking into account the number of programs of those companies
as compared to the Company, and recent market conditions. The Company advises the Staff that the preliminary
estimated price range of $10.00 to $12.00 per share (the “Preliminary Price Range”) for its IPO is based on
these considerations. However, the Company believes that the Preliminary Price Range will not be subject to significant change.
On August 24, 2020, the Company effected a 1-for-1.14396 reverse stock split of the issued and outstanding shares of its common
stock and presents post-reverse stock split share numbers and per-share price information in the Registration Statement. This response
letter presents all share numbers and per-share price information on the post-reverse stock split basis.
September 22, 2020
Page 2
Summary of Equity Awards Since January
1, 2019
Grant Date
Type of Award
Number of Shares Underlying Awards
Per Share Exercise Price
Per Share Fair Value of Common Stock on Grant Date
January 1, 2019
Warrant
20,533
$4.79
$5.57
March 1, 2019
Option
43,708
$5.57
$5.57
March 1, 2019
Option
87,416
$5.57
$5.57
April 1, 2019
Warrant
31,470
$5.57
$5.57
July 1, 2019
Option
43,708
$5.57
$5.57
July 1, 2019
Option
87,416
$5.57
$5.57
September 1, 2019
Option
43,708
$5.57
$5.57
September 1, 2019
Option
87,416
$5.57
$5.57
September 1, 2019
Option
43,708
$5.57
$5.57
September 1, 2019
Option
87,416
$5.57
$5.57
November 1, 2019
Option
21,854
$5.57
$5.57
March 31, 2020
Warrant
26,225
$5.67
$5.67
August 25, 2020
Warrant
21,854
$5.90
$5.90
August 25, 2020
Warrant
150,000
$5.90
$5.90
Summary of Share Issuances and Sales
Since January 1, 2019
Sale Date
Type
Number of Shares
Per Share Consideration Paid
Per Share Fair Value on Sale Date
January 20, 2020
Common Stock
874
$5.57
$5.57
June 30, 2020
Common Stock
11,594
$5.50
$5.50
August 25, 2020
Common Stock
13,301
$5.901
$5.90
Historical Determination of the Fair
Value of Common Stock
As there has been no public market for the Company’s
common stock to date, the estimated fair value of its common stock has been determined by the Board as of the date of each warrant
or option grant, sale or note conversion, based in part on the Company’s most recent third-party valuations performed by
an independent valuation firm of its common stock and the Board’s assessment of additional objective and subjective factors
that it believed were relevant and which may have changed from the date of the most recent third-party valuation through the date
of each warrant or option grant, sale or note conversion. The standard of value used in these third-party determinations of fair
market value of the Company’s common stock was based upon appraisal standards, valuation methodologies and approaches in
conformity with Internal Revenue Service guidelines to consider “all relevant facts and circumstances” and appraisal
guidelines endorsed by the American Institute of Certified Public Accountants as outlined in its Audit and Accounting Practice
Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the “Practice Aid”). The
valuations were prepared using risk-adjusted net present value (“rNPV”), methods for the various models where
the resulting combined weighted equity values are allocated using an option-pricing method.
1 Applicable only to the net-share settlement portion
of warrant exercise.
September 22, 2020
Page 3
The Company’s most recent third-party valuations
which were used, in part, by the Board to determine the fair value of the Company’s common stock as of the grant date of
each option award, considered two future-event scenarios in determining the enterprise value that was to be allocated: an IPO
scenario and a non-IPO liquidity event (i.e., an M&A scenario). The Board then applied a discount for lack of
marketability (“DLOM”) to the resulting common share price in consultation with the independent valuation
firm. Key assumptions used by the independent valuation firm in its most recent valuations were applied, and the
resulting indicated fair value of common stock, were as follows:
IPO Scenario
Baseline Scenario
Valuation Date
Probability
Weighting
DLOM
Probability
Weighting
DLOM
Indicated Fair Value per
Share of Common Stock
July 24, 2020
27 %
22.2 %
73 %
22.2 %
$ 5.90
December 9, 2019
25 %
27.0 %
75 %
27.0 %
$ 5.67
December 7, 2018
25 %
25.0 %
75 %
27.0 %
$ 5.57
As evident from the table above, the probability of success
of an IPO changed very little between the valuation model developed in the fourth quarter of 2018 and the model developed in the
third quarter of 2020. The principal reason for this is that the Company had confidentially submitted to the Commission an amended
draft registration statement on October 16, 2018, but the Company’s “testing the waters” discussions with investors
during October 2018 were unsuccessful, making the likelihood of success in an IPO relatively low. Nearly two years later, the
Company still sees the barrier to a successful offering as relatively high given the Company’s inability to raise private
cross-over financing of its common stock in the intervening period, supporting the model’s assumptions on the likelihood
of IPO success.
July 24, 2020 Valuation
The July 24, 2020 valuation in its determination of the
fair value of the Company’s common stock of $5.90 per share for the period from July 2020 through August 2020, during
which period the Company granted seven-year warrants for an aggregate of 171,854 shares with an exercise price of $5.90 per
share and issued 13,301 shares in connection with a cashless exercise of 21,854 warrant shares with an exercise price of
$2.31 per share. The Board determined that no significant internal or external value-generating events had taken place
between the July 24, 2020 valuation report and the August 25, 2020 grant date.
September 22, 2020
Page 4
December 9, 2019 Valuation
The Board issued 874 shares at $5.57 per share in January
2020 because the results of the December 9, 2019 valuation were not finalized until March 2020. The Board relied on the
results of the December 9, 2019 valuation in its determination of the fair value of the Company’s common stock of $5.67
per share for the period from March 2020 through July 2020. During such period, the Company granted a seven-year warrant for
26,225 shares with an exercise price of $5.67 per share. The Company also issued 11,594 shares of common stock in connection
with a partial conversion of a promissory note at a conversion price of $5.50 per share based on prior agreement. The Board
determined that no significant internal or external value-generating events had taken place between March 2020 finalization
of the December 9, 2019 valuation report and the March 31, 2020 and June 30, 2020 grant dates.
December 7, 2018 Valuation
The Board relied on the results of the December 7, 2018
valuation in its determination of the fair value of common stock of $5.57 per share for the period from December 2018 through
November 2019. During such period, the Company granted seven-year warrants for an aggregate of 31,470 shares with an exercise
price of $5.57 per share, options for 546,350 shares with an exercise price of $5.57 per share and a seven-year warrant for
20,533 shares with an exercise price of $4.79 per share. The Board determined that no significant internal or external
value-generating events had taken place between the December 7, 2018 valuation report and the January 1, 2019, March 1, 2019,
April 1, 2019, July 1, 2019, September 1, 2019 and November 1, 2019 grant dates.
Principal reasons for the differences
between the $5.90 July 24, 2020 valuation of the Company’s common stock and the estimated offering price range $10.00 to
$12.00
On August 19, 2020, the Company and its underwriters commenced
discussions of the Preliminary Price Range, which resulted in a Preliminary Price Range of $10.00 to $12.00 per share for this
offering. As is typical in an initial public offering, the estimated price range for the offering was not derived using a formal
determination of estimated fair value, but was determined primarily by discussions between the Company and the representative
of the underwriters. Among the factors that were considered in setting the Preliminary Price Range were the following:
• an analysis of the current step-ups from the last private
rounds and typical valuation ranges seen in recent initial public offerings for clinical-stage biotechnology companies;
• the general condition of the securities markets and the
recent market prices of, and the demand for, publicly traded common stock of generally comparable companies;
• an assumption that there would be a receptive public
trading market for pre-commercial,clinical- stage biotechnology companies such as the Company; and
• an assumption that there would be sufficient demand for
the Company’s common stock to support an offering of the size contemplated by the Company.
The midpoint of the Preliminary Price Range is $11.00 per share. In comparison, the Company’s estimate of the fair
value of its common stock was $5.90 per share as of July 24, 2020. The fair market value of the Company’s common stock was
determined utilizing the rNPV option-pricing model as performed by an independent third-party valuation firm as described above.
We note that, as is typical in initial public offerings, the Preliminary Price Range for this offering was not derived using a
formal determination of fair value, but factors including the Company’s prospects, and the history of and prospects for the
Company’s industry, the general condition of the securities markets and the recent market prices of, and the demand for,
publicly-traded common stock of generally comparable companies. The Company believes that the difference between the fair value
of its common stock as of July 24, 2020 and the midpoint of the Preliminary Price Range for this offering is primarily the result
of several factors, including the following:
• The uncertainty as to whether the offering would actually conclude, particularly in light of the Company’s unsuccessful offering
in 2018;
• The uncertainty as to the offering price range and estimated size;
• The commencement, utilizing proceeds from the offering, shortly following the successful
completion of the offering of clinical dosing in neurodegenerative disease which could significantly improve the
Company’s prospects for success;
September 22, 2020
Page 5
• The completion of this offering would provide the Company with access to the public company
debt and equity markets. This liquidity of publicly tradeable securities will enable the Company to raise additional capital
or make strategic acquisitions as the Board may deem appropriate, ultimately providing enhanced operational flexibility.
These projected improvements in the Company’s financial position influenced the increased common stock valuation
indicated by the Preliminary Price Range;
• The Company’s expectations that the proceeds from the offering will enable it to initiate a Phase 1 clinical trial for its lead
product candidate in the near term;
• The lack of marketability of the Company’s securities as a private company; and
• The market performance of similar companies in the pharmaceutical industry.
Unlike the valuations performed in connection with the
Company’s stock option grants, equity sales and n
2020-09-15 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP
1
filename1.htm
Troutman
Pepper Hamilton Sanders LLP
620
Eighth Avenue, 37th Floor
New
York, NY 10018
troutman.com
September 15, 2020
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549-3720
Attention: Rolf Sundwall
Sasha Parikh
Abby Adams
Suzanne Hayes
Re: Inhibikase Therapeutics, Inc.
Registration Statement on Form
S-1
Filed July 23, 2020
CIK No. 0001750149
Ladies and Gentlemen:
On behalf of our client,
Inhibikase Therapeutics, Inc. (“Inhibikase” or the “Company”), we submit this letter in response
to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
contained in its letter dated August 14, 2020 (the “Comment Letter”), relating to the above referenced Registration
Statement on Form S-1 (the “Registration Statement”). We are concurrently submitting via EDGAR this letter and
filing the revised Registration Statement.
In this letter, we
have recited the comments from the Staff in italicized, bold type and have followed each comment with the Company’s response.
Except for the page references contained in the comments of the Staff, or as otherwise specifically indicated, page references
herein correspond to the page of the revised the Registration Statement.
Registration
Statement on Form S-1 submitted July 23, 2020
Inside Cover
Page, page i
Please revise the gatefold "Method
of Action" graphic to include a textual description putting graphics in context. Without this information it is difficult
to understand what the graphics are attempting to convey. We note that the line item for BCR-Abl in the pipeline table appears
to say that you will rely on the 505(b)(2) process in lieu of conducting Phase 1 and Phase 2 trials. This is inconsistent with
later tables on page 3 and 96, which indicate you intend to rely on 505(b)(2) for all phases of clinical trials. The tables are
also inconsistent with the disclosure on page 105 indicating clinical trials are likely necessary for purposes of dose escalation
and to demonstrate superiority. Please revise your tables accordingly.
September
15, 2020
Page 2
The
Company respectfully advises the Staff that it has revised the graphic to address the Staff’s comment. Text has been added
to explain that the target of IkT-148009 for treatment of neurodegenerative disease is c-Abl in the brain. IkT-148009 acts as inhibitor
of c-Abl kinase through clearance of α-synuclein. As stated in the added text, this inhibition has been shown to halt progression
and restore function in the Company’s Parkinson’s Disease preclinical models.
To
address the second point, we have clarified the graphic and the Registration Statement to indicate that the Company intends to
seek approval for IkT-001Pro following the alternative 505(b)(2) pathway. This pathway will allow us to rely, in part, on clinical
data in the public domain or the FDA’s prior conclusions regarding the safety and effectiveness of an approved compound and,
as a result does not follow the typical Phase 1, 2 and 3 clinical trial process. The arrow in the pipeline table inadvertently
only covered Phase 1 and 2. It should have covered Phase 1, 2 and 3 consistent with the other references identified in this comment.
We note your pipeline table includes
line items for drug candidates for treatment of dementia with Lewy Body, multiple system atrophy and progressive multifocal leukoencephalophy.
Given the lack of disclosure of these programs in your registration statement, they do not appear material to your operations.
Please limit your pipeline table to your material product candidates.
The Company respectfully advises the Staff that
it has retained its additional preclinical drug candidates in the pipeline table as it considers these programs to be material.
The Company identified these development opportunities through its proprietary RAMPTM drug discovery program. A discussion
of these research programs has been added to the Registration Statement on pages 3, 5, 83-84, and 110-111.
Prospectus Summary
Overview, page 1
Please refer to comment 2 and comments
1 and 3 of our October 5, 2018 letter. On pages 2, 4, 82, and 93 you state, "Subject to future FDA agreements . . . clinical
development of IkT-001 Pro could possibly be completed in the first half of 2022." In the "Our Programs" section,
you state, "If approved by the FDA, this product might provide a revenue stream to help support other programs in neurodegeneration."
On pages 2 and 82, you state that you could complete clinical development of IkT-148009 in 2024. Please explain, how IKT-001 might
provide a revenue stream to support clinical development of IkT-148009. If this expectation is dependent on revenue from potential
collaboration agreements, please make that clear. Alternatively, clarify that this financing strategy is dependent on FDA approval
and successful commercialization which is highly uncertain.
The Company respectfully
advises the Staff that it has revised the disclosure on pages 3, 5 and 83 of the Registration Statement to clarify that, if
IkT-001Pro is approved by the FDA, the Company would seek to partner with a pharmaceutical company to produce and market the
product. Depending on the terms of the agreement, the Company may realize some revenue from this partnership that could
financially contribute to its primary efforts in neurodegenerative diseases, including continued development of
IkT-148009.
In addition, the risk factors clearly convey that drug development, FDA approval and successful commercialization are highly uncertain
and involve a substantial degree of risk. For examples, see risk factors on pages 14, 17-18, 24, 34-40, and 27-31.
September
15, 2020
Page 3
Briefly explain all defined terms
at first use. For example, on page 2, briefly describe the process and significance of submitting the NDA for IkT-001Pro pursuant
to Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act.
The Company respectfully advises
the Staff that it has revised the disclosure on page 2 of the Registration Statement to clarify that development through the 505(b)(2)
pathway would allow it to rely, in part, on data in the public domain or the FDA’s prior conclusions regarding the safety
and effectiveness of an approved compound. We have further revised the Registration Statement to explain other defined terms at
first use.
On pages 2 and 81, you state, "We
believe IkT-001Pro will improve patient experience and treatment compliance and could become the standard-of-care as a result,"
while acknowledging you will not submit an IND until the fourth quarter of 2020. On page 103, you state, "We believe IkT-001Pro
will have superior safety and at least equivalent efficacy relative to generic Imatinib. As a consequence, we believe we have an
opportunity to capture a significant portion of the generic Imatinib sales in the U.S. market." Please remove these and all
statements suggesting that your product candidates are effective. Safety and efficacy determinations are solely within authority
of the FDA or other regulatory agencies. As your product candidates have not received approval, it is premature to state or suggest
that they are effective.
The Company respectfully advises
the Staff that it has removed all statements suggesting that the safety and effectiveness of IkT-001Pro have been confirmed.
Our Portfolio, page 94
On page 96, Table 1 depicts the development
of IkT-001Pro while the footnote relates to the development of IkT-148009. Revise accordingly.
The Company respectfully
advises the Staff that it has removed the footnote.
Material Agreements, page 109
Tell us why you eliminated disclosure
of the Duke license. We note from pages F-19--20, that it appears the Duke license agreement continues to be in effect.
The Company respectfully advises
the Staff that the Duke license has been terminated and the Company has revised the disclosure on page F-22 of the Registration
Statement to clarify that the Duke license has been terminated.
Certain Relationships and Related Party Transactions,
page 148
Describe the material terms of the
CEO note and the 2018 consulting agreement with Flagship Consulting, through which you agreed to compensate Mr. Frattaroli, your
CFO, discussed on page 148, and file these agreements as exhibits. Refer to Item 601(b)(10)(ii)(A) and (iii)(A). We note you have
filed the 2018 promissory note; however, the terms of that note (based on monthly statements for services rendered, maximum $75,000)
do not appear to match your disclosure for that time period ($12,500 per month accruing on convertible revolving demand promissory
note). Revise to clarify.
September
15, 2020
Page 4
The Company respectfully advises
the Staff that it has revised the disclosure on pages 92-93, 148-150 and 161 of the Registration Statement to address the Staff’s
comment by describing the terms of the 2018 note to Flagship Consulting, Inc., the 2018 note to Mr. Frattaroli, the 2018 consulting
agreement with Flagship Consulting, Inc., the 2019 note to Mr. Frattaroli, the 2020 amended and restated note to Flagship Consulting,
Inc., and two warrants granted to Flagship Consulting, Inc.
* * *
We hope that the foregoing
has been responsive to the Staff’s comments. Please direct any questions with respect to this submission to me at (212) 808-2711
or merrill.kraines@troutman.com.
Sincerely,
/s/ Merrill M. Kraines
Merrill M. Kraines, Esq.
cc: Milton H. Werner, Ph.D., Inhibikase Therapeutics, Inc.
Todd Kornfeld, Esq., Troutman Pepper Hamilton Sanders LLP
Leslie Marlow, Esq., Gracin & Marlow
LLP
2020-08-14 - UPLOAD - Inhibikase Therapeutics, Inc.
United States securities and exchange commission logo
August 14, 2020
Milton H. Werner
President and Chief Executive Officer
Inhibikase Therapeutics, Inc.
3350 Riverwood Parkway SE, Suite 1927
Atlanta, GA 30339
Re:Inhibikase Therapeutics, Inc.
Registration Statement on Form S-1
Filed July 23, 2020
File No. 333-240036
Dear Dr. Werner:
We have reviewed your registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-3
Inside Cover Page, page i
1.Please revise the gatefold "Method of Action" graphic to include a textual description
putting graphics in context. Without this information it is difficult to understand what the
graphics are attempting to convey. We note that the line item for BCR-Abl in the pipeline
table appears to say that you will rely on the 505(b)(2) process in lieu of conducting Phase
1 and Phase 2 trials. This is inconsistent with later tables on page 3 and 96, which
indicate you intend to rely on 505(b)(2) for all phases of clinical trials. The tables are also
inconsistent with the disclosure on page 105 indicating clinical trials are likely necessary
for purposes of dose escalation and to demonstrate superiority. Please revise your tables
accordingly.
FirstName LastNameMilton H. Werner
Comapany NameInhibikase Therapeutics, Inc.
August 14, 2020 Page 2
FirstName LastName
Milton H. Werner
Inhibikase Therapeutics, Inc.
August 14, 2020
Page 2
2.We note your pipeline table includes line items for drug candidates for treatment of
dementia with Lewy Body, multiple system atrophy and progressive multifocal
leukoencephalophy. Given the lack of disclosure of these programs in your registration
statement, they do not appear material to your operations. Please limit your pipeline table
to your material product candidates.
Prospectus Summary
Overview, page 1
3.Please refer to comment 2 and comments 1 and 3 of our October 5, 2018 letter. On pages
2, 4, 82, and 93 you state, "Subject to future FDA agreements . . . clinical development of
IkT-001 Pro could possibly be completed in the first half of 2022." In the "Our Programs"
section, you state, "If approved by the FDA, this product might provide a revenue stream
to help support other programs in neurodegeneration." On pages 2 and 82, you state that
you could complete clinical development of IkT-148009 in 2024. Please explain, how
IKT-001 might provide a revenue stream to support clinical development of IkT-148009.
If this expectation is dependent on revenue from potential collaboration agreements,
please make that clear. Alternatively, clarify that this financing strategy is dependent on
FDA approval and successful commercialization which is highly uncertain.
4.Briefly explain all defined terms at first use. For example, on page 2, briefly describe the
process and significance of submitting the NDA for IkT-001Pro pursuant to Section
505(b)(2) of the Federal Food, Drug and Cosmetic Act.
5.On pages 2 and 81, you state, "We believe IkT-001Pro will improve patient experience
and treatment compliance and could become the standard-of-care as a result," while
acknowledging you will not submit an IND until the fourth quarter of 2020. On page 103,
you state, "We believe IkT-001Pro will have superior safety and at least equivalent
efficacy relative to generic Imatinib. As a consequence, we believe we have an
opportunty to capture a significant portion of the generic Imatinib sales in the U.S.
market." Please remove these and all statements suggesting that your product candidates
are effective. Safety and efficacy determinations are solely within authority of the FDA or
other regulatory agencies. As your product candidates have not received approval, it is
premature to state or suggest that they are effective.
Our Portfolio, page 94
6.On page 96, Table 1 depicts the development of IkT-001Pro while the footnote relates to
the development of IkT-148009. Revise accordingly.
Material Agreements, page 109
7.Tell us why you eliminated disclosure of the Duke license. We note from pages F-19-
20, that it appears the Duke license agreement continues to be in effect.
FirstName LastNameMilton H. Werner
Comapany NameInhibikase Therapeutics, Inc.
August 14, 2020 Page 3
FirstName LastName
Milton H. Werner
Inhibikase Therapeutics, Inc.
August 14, 2020
Page 3
Certain Relationships and Related Party Transactions, page 148
8.Describe the material terms of the CEO note and the 2018 consulting agreement with
Flagship Consulting, through which you agreed to compensate Mr. Frattaroli, your CFO,
discussed on page 148, and file these agreements as exhibits. Refer to Item
601(b)(10)(ii)(A) and (iii)(A). We note you have filed the 2018 promissory note;
however, the terms of that note (based on monthly statements for services rendered,
maximum $75,000) do not appear to match your disclosure for that time period ($12,500
per month accruing on convertible revolving demand promissory note). Revise to clarify.
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 Rolf Sundwall at (202) 551-3105 or Sasha Parikh at (202) 551-3627 if
you have questions regarding the financial statements and related matters. Please contact Abby
Adams at (202) 551-6902 or Suzanne Hayes at (202) 551-3675 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Merrill M. Kraines, Esq.
2020-07-23 - CORRESP - Inhibikase Therapeutics, Inc.
CORRESP
1
filename1.htm
Troutman
Pepper Hamilton Sanders LLP
620 Eighth Avenue,
37th Floor
New York, NY 10018
troutman.com
July 23, 2020
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Healthcare & Insurance
100 F Street, N.E.
Washington, D.C. 20549-3720
Attention: Rolf Sundwall
Sharon
Blume
Irene
Paik
Suzanne
Hayes
Re: Inhibikase Therapeutics, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted October 16, 2018
CIK No. 0001750149
Ladies and Gentlemen:
On behalf of our client,
Inhibikase Therapeutics, Inc. (“Inhibikase” or the “Company”), we submit this letter in response
to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
contained in its letter dated October 31, 2018 (the “Comment Letter”), relating to the above referenced Amendment
No. 1 to Draft Registration Statement on Form S-1 (the “Registration Statement”). We are concurrently submitting
via EDGAR this letter and the revised Registration Statement.
In this letter, we
have recited the comments from the Staff in italicized, bold type and have followed each comment with the Company’s response.
Except for the page references contained in the comments of the Staff, or as otherwise specifically indicated, page references
herein correspond to the page of the revised Registration Statement.
Amendment No.
1 to Draft Registration Statement on Form S-1 submitted October 16, 2018
Cover Page
We note your statement
that no assurance can be given that your application to list your common stock on the Nasdaq Capital Market will be approved. Please
revise your disclosure here and elsewhere as appropriate to clarify whether approval of the Nasdaq listing is a condition to the
offering.
The
Company respectfully advises the Staff that it has revised the disclosure on the cover page and pages 10 and 164 of the Registration
Statement to address the Staff’s comment. The Company has revised its disclosure to clarify that approval of the Nasdaq listing
is a condition to the completion of the offering.
July 23, 2020
Page 2
Overview, page 1
We note your response to our prior
comment three. Please delete the statement that you will complete the requirements for submissions of a New Drug Application in
2020. The statement predicting the completion of trials that you have not submitted an application to begin is speculative, assumes
positive results and is not appropriate. We will not object to an estimate concerning the length of clinical trials. However, you
should also indicate that the FDA may not agree with your trial design and the trials may take longer than anticipated.
The
Company respectfully advises the Staff that it has revised the disclosure on page 2 of the Registration Statement to address the
Staff’s comment. The Company has removed the statement related to the completion of the requirements for submissions of a
New Drug Application (“NDA”) in 2020.
Risk Factors
Our amended and restated
certificate of incorporation that will become effective upon the completion… page 64
We note that the forum selection
provision in your amended and restated certificate of incorporation identifies the Court of Chancery of the State of Delaware as
the exclusive forum for certain litigation, including any “derivative action.” Please disclose whether this provision
applies to actions arising under the Exchange Act. Also ensure that the exclusive forum provision in your proposed organizational
documents states this clearly. In this 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. In
addition, we note that you select the federal district courts as the exclusive forum for causes of action arising under the Securities
Act. Please revise your disclosure to address the uncertainty regarding the enforceability of this provision.
The
Company respectfully advises the Staff that it has revised the disclosure on pages 68, 154 and 155 of the Registration Statement
and page 7 of exhibit 3.2 to address the Staff’s comment. The Company has revised its restated certificate of incorporation
to be effective upon completion of the Company’s initial public offering to clarify that the forum selection provision that
identifies the Court of Chancery of the State of Delaware as the exclusive forum for certain litigation, including any “derivative
action”, would not apply to suits to enforce a duty or liability created by the Securities Exchange Act of 1934. In addition,
the Company has revised its disclosure on page 68 to state that there is uncertainty as to whether a court would enforce a provision
selecting the federal district courts as the exclusive forum for causes of action arising under the Securities Act of 1933, as
amended, and that some companies that adopted a similar federal district court forum selection provision are currently subject
to a suit in the Chancery Court of Delaware by stockholders who assert that the provision is not enforceable.
July 23, 2020
Page 3
We
hope that the foregoing has been responsive to the Staff’s comments. Please direct any questions with respect to this confidential
submission to me at (212) 808-2711 or krainesm@troutman.com.
Sincerely,
/s/ Merrill M. Kraines
Merrill M. Kraines,
Esq.
cc: Milton H. Werner, Ph.D., Inhibikase Therapeutics, Inc.
Todd
Kornfeld, Esq., Troutman Pepper Hamilton Sanders LLP
Leslie
Marlow, Esq., Gracin & Marlow LLP
2018-10-31 - UPLOAD - Inhibikase Therapeutics, Inc.
October 31, 2018
Milton Werner
President and Chief Executive Officer
Inhibikase Therapeutics, Inc.
3350 Riverwood Parkway SE, Suite 1900
Atlanta, GA 30339
Re:Inhibikase Therapeutics, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted October 16, 2018
CIK No. 0001750149
Dear Dr. Werner:
We have reviewed your amended 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
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form S-1 submitted October 16, 2018
Cover Page
1.We note your statement that no assurance can be given that your application to list
your common stock on the Nasdaq Capital Market will be approved. Please revise
your disclosure here and elsewhere as appropriate to clarify whether approval of the
Nasdaq listing is a condition to the offering.
FirstName LastNameMilton Werner
Comapany NameInhibikase Therapeutics, Inc.
October 31, 2018 Page 2
FirstName LastName
Milton Werner
Inhibikase Therapeutics, Inc.
October 31, 2018
Page 2
Prospectus Summary
Overview, page 1
2.We note your response to our prior comment three. Please delete the statement that you
will complete the requirements for submissions of a New Drug Application in 2020. The
statement predicting the completion of trials that you have not submitted an application to
begin is speculative, assumes positive results and is not appropriate. We will not object
to an estimate concerning the length of clinical trials. However, you should also indicate
that the FDA may not agree with your trial design and the trials may take longer than
anticipated.
Risk Factors
Our amended and restated certificate of incorporation that will become effective upon the
completion..., page 64
3.We note that the forum selection provision in your amended and restated certificate of
incorporation identifies the Court of Chancery of the State of Delaware as the exclusive
forum for certain litigation, including any “derivative action.” Please disclose whether
this provision applies to actions arising under the Exchange Act. Also ensure that the
exclusive forum provision in your proposed organizational documents states this clearly.
In this 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. In addition, we note that you select the
federal district courts as the exclusive forum for causes of action arising under the
Securities Act. Please revise your disclosure to address the uncertainty regarding the
enforceability of this provision.
You may contact Rolf Sundwall at 202-551-3105 or Sharon Blume at 202-551-3474 if
you have questions regarding comments on the financial statements and related matters. Please
contact Irene Paik at 202-551-6553 or Suzanne Hayes at 202-551-3675 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Merrill M. Kraines, Esq.
2018-10-10 - UPLOAD - Inhibikase Therapeutics, Inc.
October 5, 2018
Milton Werner
President and Chief Executive Officer
Inhibikase Therapeutics, Inc.
3350 Riverwood Parkway SE, Suite 1900
Atlanta, GA 30339
Re:Inhibikase Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted August 31, 2018
CIK No. 0001750149
Dear Dr. Werner:
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
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1
Our Programs, page 1
1.Please delete the statement that IkT-001Pro is a "near-term commercial opportunity." The
statement inappropriately assumes the successful result of your clinical trials and FDA
approval. Additionally, clarify whether the FDA has made a final determination that a
single 12-24 patient trial is sufficient to support the submission of an NDA.
2.Please describe the significance of three columns under the Biomarker column.. For
example, please tell us how you are "Validating" clinical target engagement prior to
initiating clinical development and the meaning of "Can be used for patient selection."
FirstName LastNameMilton Werner
Comapany NameInhibikase Therapeutics, Inc.
October 5, 2018 Page 2
FirstName LastNameMilton Werner
Inhibikase Therapeutics, Inc.
October 5, 2018
Page 2
Overview, page 1
3.Please balance your disclosure in the Prospectus Summary regarding the near-term
commercial opportunity you have with IkT-001Pro by indicating your current stage of
development, rather than indicating when you anticipate you will complete the clinical
development, and whether you have filed an IND for IkT-001Pr. Please also clarify that
validating the pharmacology advantage will require a post-approval study to demonstrate
comparative efficacy and safety results to Imatinib.
Implications of Being an Emerging Growth Company and a Smaller Reporting Company , page
6
4.Please supplementally provide us with copies of all written communications, as defined
in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your
behalf, present to potential investors in reliance on Section 5(d) of the Securities Act,
whether or not they retain copies of the communications.
Some intellectual property may have been discovered through governemt funded programs ,
page 48
5.Please identify your product candidates that are dependent on patent rights subject to
"march in" rights.
Use of Proceeds, page 67
6.If any of the net proceeds of the offering, together with existing resources, will be used to
develop IkT-001Pro, please disclose the amount you will allocate to its development and
the development stage you expect to reach.
7.Please revise this section to clarify whether you will be able to complete the Phase 2
clinical trials in early-stage PD patients and treatment-naive PD patients with your
existing cash and the net proceeds of this offering. To the extent you will need to raise
additional capital to complete such stage of development, please disclose the amount and
sources of such other funds needed to complete such trials. Refer to Instruction 3 to Item
504 of Regulation S-K.
Results of Operations
Research and Development, page 79
8.You disclose on page 78 that external costs are tracked by therapeutic indication. Please
revise your disclosures here to include the external costs incurred during each period
presented for each program or therapeutic area separately to provide more transparency as
to the type of expenses incurred.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Significant Judgments and Estimates
FirstName LastNameMilton Werner
Comapany NameInhibikase Therapeutics, Inc.
October 5, 2018 Page 3
FirstName LastNameMilton Werner
Inhibikase Therapeutics, Inc.
October 5, 2018
Page 3
Stock-Based Compensation , page 84
9.Once you have an estimated offering price or range, please explain to us how you
determined the fair value of the common stock underlying your equity issuances and the
reasons for any differences between the recent valuations of your common stock leading
up to the IPO and the estimated offering price. This information will help facilitate our
review of your accounting for equity issuances including stock compensation and
beneficial conversion features.
Critical Accounting Policies and Significant Judgments and Estimates
Stock-Based Compensation , page 85
10.On this page, you disclose you estimate the fair value of stock options using the reduced
Net Product Value, or rNPV, option pricing model as performed by an independent third
party consultant. On page F-10, you disclose you use the Black-Scholes-Merton option
pricing model to determine the fair value of stock options. Please clarify which model
you use and revise your disclosures for consistency.
Business
Overview, page 88
11.We note your statement on page 88 that you believe you 'pre-determine' the human safety
margin of your novel chemical entities using the RAMP drug discovery program.
Statements regarding safety are determinations that only the FDA has the authority to
make. Please revise your disclosure here to eliminate any suggestion that your product
candidates have been or will ultimately be determined safe, reduced/eliminated risks
related to safety or to have demonstrated safety for purposes of granting marketing
approval by the FDA or comparable agency.
Clinical Development Strategy for IkT-001Pro in Stable Phase CML, page 97
12.We note that your pipeline table and the discussion of the toxicity and tolerability
discussion on page 96 appear to indicate that you have completed the Ikt-001Pro
preclinical trial in monkeys. However, your discussion on page 97 indicates the trial is
still ongoing. Please revise your disclosure to address the apparent inconsistency. If you
have completed the preclinical study, please describe the observable data resulting from
the trial. In addition, please explain your statement that you "believe the FDA is requiring
a single dose comparison study."
Material Agreements, page 101
13.We note that you have funded your operations primarily through private, state and federal
contracts and grants, including from the National Institutes of Health, Department of
Defense and State of Georgia. Please expand your disclosure to describe the terms of the
FirstName LastNameMilton Werner
Comapany NameInhibikase Therapeutics, Inc.
October 5, 2018 Page 4
FirstName LastNameMilton Werner
Inhibikase Therapeutics, Inc.
October 5, 2018
Page 4
research grants you received from these institutions. For instance, clarify whether the
government has any rights to the products developed with the funds received, whether
there are any circumstances under which you may have to pay back the funds received,
etc. Alternatively, provide an analysis as to why you believe such disclosure is not
required.
Duke University, page 102
14.Please disclose when the agreement expires.
Sphaera Pharma Pte. Ltd., page 103
15.We note your disclosure indicates that Sphaera is entitled to milestone payments upon the
achievement of certain preclinical, clinical and regulatory milestones. You have disclosed
the payments related to dosing of the first patient in a Phase 1 clinical trial and FDA
approval. Please revise your disclosure regarding the milestone payments to also disclose
payments related to your preclinical milestones and indicate whether the milestone has
been met or you anticipate achieving it in the near future. Additionally, confirm that the
payments disclosed constitute all milestone payments. Alternatively, quantify the
milestone payments made to date and all remaining potential milestone payments.
Sponsored Research Agreements, page 103
16.We note that you have entered into sponsored research agreements with academic and
research institutions to perform certain testing and research for you and that you currently
do not have a research and development facility of your own. To the extent any of the
sponsored research agreements identified are material to your business, please describe
their material terms , and file them as exhibits to your registration statement.
Alternatively, please explain why you believe these agreements are not material.
Government Regulation, page 106
17.We note your belief that approval of IkT-001Pro can be achieved through the 505(b)(2)
regulation. Please expand your disclosure in this section to explain the 505(b)(2)
regulatory pathway and how the requirements differ from the traditional pathway.
Management, page 120
18.Please revise the biographies of each of the key non-executive officers and non-employee
directors to state the period(s) during which each individual served in
such capacity. Please also disclose the principal occupations and employment of Surendra
Singh and Lisa Evrén during the past five years. Refer to Item 401(a), (c) and (e) of
Regulation S-K.
Notes to Financial Statements
10. Commitments and Contingencies
FirstName LastNameMilton Werner
Comapany NameInhibikase Therapeutics, Inc.
October 5, 2018 Page 5
FirstName LastName
Milton Werner
Inhibikase Therapeutics, Inc.
October 5, 2018
Page 5
License Agreements, page F-18
19.Please revise your disclosure of the Sphaera Pharma Pte. Ltd. collaboration agreement to
include the total aggregate amount of potential milestone payments Sphaera may be
entitled to receive under the agreement.
General
20.Please provide us proofs of all graphics, visual, or photographic information you will
provide in the printed prospectus prior to its use, for example in a preliminary prospectus.
You may contact Rolf Sundwall at 202-551-3105 or Sharon Blume at 202-551-3474 if
you have questions regarding comments on the financial statements and related matters. Please
contact Irene Paik at 202-551-6553 or Suzanne Hayes at 202-551-3675 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Merrill M Kraines
2018-09-07 - UPLOAD - Inhibikase Therapeutics, Inc.
September 6, 2018
Milton Werner
President and Chief Executive Officer
Inhibikase Therapeutics, Inc.
3350 Riverwood Parkway SE, Suite 1900
Atlanta, GA 30339
Re:Inhibikase Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted August 31, 2018
CIK No. 0001750149
Dear Dr. Werner:
We have reviewed your draft registration statement and have the following comment. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by 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 comment applies 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 the comment and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1
General
1.We note that you have not included the unaudited interim financial statements for the
period ended June 30, 2018, and you have not indicated that these financial statements are
not expected to be required at the time of the contemplated offering. As such, it does not
appear that you are relying on the accommodation set forth in the Fixing America's
Surface Transportation (FAST) Act to omit this interim financial information. Therefore,
please amend your submission to include your interim June 30, 2018 financial statements
FirstName LastNameMilton Werner
Comapany NameInhibikase Therapeutics, Inc.
September 6, 2018 Page 2
FirstName LastName
Milton Werner
Inhibikase Therapeutics, Inc.
September 6, 2018
Page 2
as required by Rule 8-08 of Regulation S-X. We will not perform a detailed examination
of the registration statement until you do so.
You may contact Jim Rosenberg at 202-551-3679 if you have questions regarding
comments on the financial statements and related matters. Please contact Dorrie Yale at 202-
551-8776 or Mary Beth Breslin at 202-551-3625 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Merrill M Kraines