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Cingulate Inc.
Response Received
1 company response(s)
High - file number match
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Cingulate Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-10-02
Cingulate Inc.
Summary
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Cingulate Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-08-26
Cingulate Inc.
Summary
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Cingulate Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-07-22
Cingulate Inc.
Summary
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Cingulate Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-05-21
Cingulate Inc.
Summary
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Cingulate Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2024-01-18
Cingulate Inc.
Summary
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Cingulate Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2023-07-26
Cingulate Inc.
Summary
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Cingulate Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-05-01
Cingulate Inc.
Summary
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Cingulate Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-01-11
Cingulate Inc.
Summary
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Cingulate Inc.
Response Received
11 company response(s)
High - file number match
SEC wrote to company
2021-09-30
Cingulate Inc.
Summary
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Cingulate Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2021-08-17
Cingulate Inc.
Summary
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Cingulate Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-07-28
Cingulate Inc.
Summary
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Cingulate Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-06-17
Cingulate Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-25 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2025-07-24 | SEC Comment Letter | Cingulate Inc. | DE | 333-288877 | Read Filing View |
| 2024-10-03 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2024-10-02 | SEC Comment Letter | Cingulate Inc. | DE | 333-282358 | Read Filing View |
| 2024-08-26 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2024-08-26 | SEC Comment Letter | Cingulate Inc. | DE | 333-281628 | Read Filing View |
| 2024-07-22 | SEC Comment Letter | Cingulate Inc. | DE | 333-280818 | Read Filing View |
| 2024-07-22 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2024-05-21 | SEC Comment Letter | Cingulate Inc. | DE | 333-279515 | Read Filing View |
| 2024-05-21 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2024-01-30 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2024-01-30 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2024-01-18 | SEC Comment Letter | Cingulate Inc. | DE | 333-276502 | Read Filing View |
| 2023-09-07 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2023-09-07 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2023-07-26 | SEC Comment Letter | Cingulate Inc. | DE | N/A | Read Filing View |
| 2023-05-01 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2023-05-01 | SEC Comment Letter | Cingulate Inc. | DE | N/A | Read Filing View |
| 2023-01-11 | SEC Comment Letter | Cingulate Inc. | DE | N/A | Read Filing View |
| 2023-01-11 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-12-03 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-12-03 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-10-14 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-10-14 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-10-12 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-10-12 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-10-06 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-10-06 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-10-04 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-10-04 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-10-01 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-09-30 | SEC Comment Letter | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-09-09 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-08-17 | SEC Comment Letter | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-07-28 | SEC Comment Letter | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-06-17 | SEC Comment Letter | Cingulate Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-24 | SEC Comment Letter | Cingulate Inc. | DE | 333-288877 | Read Filing View |
| 2024-10-02 | SEC Comment Letter | Cingulate Inc. | DE | 333-282358 | Read Filing View |
| 2024-08-26 | SEC Comment Letter | Cingulate Inc. | DE | 333-281628 | Read Filing View |
| 2024-07-22 | SEC Comment Letter | Cingulate Inc. | DE | 333-280818 | Read Filing View |
| 2024-05-21 | SEC Comment Letter | Cingulate Inc. | DE | 333-279515 | Read Filing View |
| 2024-01-18 | SEC Comment Letter | Cingulate Inc. | DE | 333-276502 | Read Filing View |
| 2023-07-26 | SEC Comment Letter | Cingulate Inc. | DE | N/A | Read Filing View |
| 2023-05-01 | SEC Comment Letter | Cingulate Inc. | DE | N/A | Read Filing View |
| 2023-01-11 | SEC Comment Letter | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-09-30 | SEC Comment Letter | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-08-17 | SEC Comment Letter | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-07-28 | SEC Comment Letter | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-06-17 | SEC Comment Letter | Cingulate Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-25 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2024-10-03 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2024-08-26 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2024-07-22 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2024-05-21 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2024-01-30 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2024-01-30 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2023-09-07 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2023-09-07 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2023-05-01 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2023-01-11 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-12-03 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-12-03 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-10-14 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-10-14 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-10-12 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-10-12 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-10-06 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-10-06 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-10-04 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-10-04 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-10-01 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
| 2021-09-09 | Company Response | Cingulate Inc. | DE | N/A | Read Filing View |
2025-07-25 - CORRESP - Cingulate Inc.
CORRESP 1 filename1.htm July 25, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Cingulate Inc. Registration Statement on Form S-1 File No. 333-288877 Acceleration Request Requested Date: July 29, 2025 Requested Time: 4:30 p.m. , Eastern Time Dear Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Cingulate Inc. (the "Company") hereby requests that the above-referenced Registration Statement (the "Registration Statement") be declared effective by the Securities and Exchange Commission (the "Commission") at the "Requested Date" and "Requested Time" set forth above or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Commission. Please call Steven M. Skolnick of Lowenstein Sandler LLP at (973) 597-2476 to confirm the effectiveness of the Registration Statement or with any questions. Sincerely, CINGULATE INC. By: /s/ Shane J. Schaffer Name: Shane J. Schaffer Title: Chief Executive Officer
2025-07-24 - UPLOAD - Cingulate Inc. File: 333-288877
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 24, 2025 Shane Schaffer Chief Executive Officer Cingulate Inc. 1901 W. 47th Place Kansas City, KS 66205 Re: Cingulate Inc. Registration Statement on Form S-1 Filed July 22, 2025 File No. 333-288877 Dear Shane Schaffer: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Tyler Howes at 202-551-3370 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Steven M. Skolnick, Esq. </TEXT> </DOCUMENT>
2024-10-03 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
October
3, 2024
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
Mail
Stop 4720
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Cingulate
Inc.
Registration
Statement on Form S-1
File
No. 333-282358
Acceleration
Request
Requested
Date:
October
7, 2024
Requested
Time:
4:30
p.m., Eastern Time
Dear
Ladies and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Cingulate Inc. (the “Company”) hereby requests that the above-referenced
Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission (the
“Commission”) at the “Requested Date” and “Requested Time” set forth above or at such later time
as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Commission.
Please
call Steven M. Skolnick of Lowenstein Sandler LLP at (973) 597-2476 to confirm the effectiveness of the Registration Statement or with
any questions.
Sincerely,
CINGULATE
INC.
By:
/s/
Shane J. Schaffer
Name:
Shane
J. Schaffer
Title:
Chief
Executive Officer
2024-10-02 - UPLOAD - Cingulate Inc. File: 333-282358
October 2, 2024
Shane Schaffer
Chief Executive Officer
Cingulate Inc.
1901 W. 47th Place
Kansas City, KS 66205
Re:Cingulate Inc.
Registration Statement on Form S-1
Filed September 27, 2024
File No. 333-282358
Dear Shane Schaffer:
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:Stephen Zapf
2024-08-26 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
August
26, 2024
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
Mail
Stop 4720
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Cingulate
Inc.
Registration
Statement on Form S-1
File
No. 333-281628
Acceleration
Request
Requested
Date:
August
27, 2024
Requested
Time:
4:30
p.m., Eastern Time
Dear
Ladies and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Cingulate Inc. (the “Company”) hereby requests that the above-referenced
Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission (the
“Commission”) at the “Requested Date” and “Requested Time” set forth above or at such later time
as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Commission.
Please
call Steven M. Skolnick of Lowenstein Sandler LLP at (973) 597-2476 to confirm the effectiveness of the Registration Statement or with
any questions.
Sincerely,
CINGULATE
INC.
By:
/s/
Shane J. Schaffer
Name:
Shane
J. Schaffer
Title:
Chief
Executive Officer
2024-08-26 - UPLOAD - Cingulate Inc. File: 333-281628
August 26, 2024
Shane J. Schaffer
Chief Executive Officer
Cingulate Inc.
1901 W. 47th Place
Kansas City, KS 66205
Re:Cingulate Inc.
Registration Statement on Form S-1
Filed August 19, 2024
File No. 333-281628
Dear Shane J. Schaffer:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that
the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Steven M. Skolnick, Esq.
2024-07-22 - UPLOAD - Cingulate Inc. File: 333-280818
July 22, 2024
Shane Schaffer
Chief Executive Officer
Cingulate, Inc.
1901 W. 47th Place
Kansas City, KS 66205
Re:Cingulate, Inc.
Registration Statement on Form S-3
Filed July 15, 2024
File No. 333-280818
Dear Shane Schaffer:
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:Tracy Buffer
2024-07-22 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
July
22, 2024
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
Mail
Stop 4720
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Cingulate Inc.
Registration Statement on Form S-3
File
No. 333-280818
Acceleration
Request
Requested
Date:
July
24, 2024
Requested
Time:
4:15
p.m., Eastern Time
Dear
Ladies and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Cingulate, Inc. (the “Company”) hereby requests that the above-referenced
Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission (the
“Commission”) at the “Requested Date” and “Requested Time” set forth above or at such later time
as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Commission.
Please
call Tracy Buffer of Lowenstein Sandler LLP at (973) 597-2434 to confirm the effectiveness of the Registration Statement or with any
questions.
Sincerely,
CINGULATE
INC.
By:
/s/
Shane Schaffer
Name:
Shane
Schaffer
Title:
Chief
Executive Officer
2024-05-21 - UPLOAD - Cingulate Inc. File: 333-279515
United States securities and exchange commission logo
May 21, 2024
Shane Schaffer
Chief Executive Officer
Cingulate Inc.
1901 W. 47th Place
Kansas City, KS 66205
Re:Cingulate Inc.
Registration Statement on Form S-1
Filed May 17, 2024
File No. 333-279515
Dear Shane Schaffer:
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: Tracy Buffer, Esq.
2024-05-21 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
May
21, 2024
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
Mail
Stop 4720
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Cingulate Inc.
Registration Statement on Form S-1
File No. 333-279515
Acceleration Request
Requested
Date:
May 23,
2024
Requested Time:
4:30 p.m., Eastern
Time
Dear
Ladies and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Cingulate Inc. (the “Company”) hereby requests that the above-referenced
Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission (the
“Commission”) at the “Requested Date” and “Requested Time” set forth above or at such later time
as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Commission.
Please
call Steven M. Skolnick of Lowenstein Sandler LLP at (973) 597-2476 to confirm the effectiveness of the Registration Statement or with
any questions.
Sincerely,
CINGULATE INC.
By:
/s/
Shane J. Schaffer
Name:
Shane J. Schaffer
Title:
Chief Executive Officer
2024-01-30 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
January
30, 2024
VIA
FACSIMILE AND EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporate Finance
Washington,
DC 20549
Re:
Cingulate,
Inc.
Registration
Statement on Form S-1 (Registration No. 333-276502) -
Concurrence
in Acceleration Request
Ladies
and Gentlemen:
H.C.
Wainwright & Co., LLC (“Wainwright”), solely acting as placement agent on a best-efforts basis in an offering
pursuant to the registration statement on Form S-1 (333-276502) (the “Registration Statement”), hereby concurs in
the request by Cingulate, Inc. that the effective date of the above-referenced registration statement be accelerated to 5:15 P.M. Eastern
Time on Thursday, February 1, 2024, or as soon as practicable thereafter, pursuant to Rule 461 under the Securities Act. Wainwright affirms
that it is aware of its obligations under the Securities Act as they pertain to the best efforts offering pursuant to the Registration
Statement.
Very truly yours,
H.C. WAINWRIGHT & CO., LLC
By:
/s/
Edward D. Silvera
Name:
Edward
D. Silvera
Title:
Chief
Operating Officer
430
Park Avenue | New York, NY 10022 | 212.356.0500 | www.hcwco.com
Member:
FINRA/SIPC
2024-01-30 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
January
30, 2024
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
Mail
Stop 4720
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Cingulate
Inc.
Registration
Statement on Form S-1
File
No. 333- 276502
Acceleration
Request
Requested
Date: February 1, 2024
Requested
Time: 5:15 p.m. Eastern Time
Dear
Ladies and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Cingulate Inc. (the “Company”) hereby requests that the above-referenced
Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission (the
“Commission”) at the “Requested Date” and “Requested Time” set forth above or at such later time
as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Commission.
Please
call Steven M. Skolnick of Lowenstein Sandler LLP at (973) 597-2476 to confirm the effectiveness of the Registration Statement or with
any questions.
Sincerely,
CINGULATE
INC.
By:
/s/
Shane J. Schaffer
Name:
Shane
J. Schaffer
Title:
Chief
Executive Officer
2024-01-18 - UPLOAD - Cingulate Inc. File: 333-276502
United States securities and exchange commission logo
January 18, 2024
Shane Schaffer
Chief Executive Officer
Cingulate Inc.
1901 W. 47th Place
Kansas City , KS 66205
Re:Cingulate Inc.
Registration Statement on Form S-1
Filed January 12, 2024
File No. 333-276502
Dear Shane Schaffer:
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: Steve Skolnick, Esq.
2023-09-07 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
September
7, 2023
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
Mail
Stop 4720
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Cingulate
Inc.
Registration
Statement on Form S-1
File
No. 333- 273405
Acceleration
Request
Requested
Date:
September
11, 2023
Requested
Time:
9:00
a.m., Eastern Time
Dear
Ladies and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Cingulate Inc. (the “Company”) hereby requests that the above-referenced
Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission (the
“Commission”) at the “Requested Date” and “Requested Time” set forth above or at such later time
as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Commission.
Please
call Steven M. Skolnick of Lowenstein Sandler LLP at (973) 597-2476 to confirm the effectiveness of the Registration Statement or with
any questions.
Sincerely,
CINGULATE
INC.
By:
/s/
Shane J. Schaffer
Name:
Shane
J. Schaffer
Title:
Chief
Executive Officer
2023-09-07 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
September
7, 2023
VIA
FACSIMILE AND EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporate Finance
Washington,
DC 20549
Re:
Cingulate Inc.
Registration Statement on Form S-1 (Registration
No. 333-273405) -
Concurrence in Acceleration Request
Ladies
and Gentlemen:
H.C.
Wainwright & Co., LLC (“Wainwright”), solely acting as placement agent on a best-efforts basis in an offering
pursuant to the registration statement on Form S-1 (333-273405) (the “Registration Statement”), hereby concurs in
the request by Cingulate Inc. that the effective date of the above-referenced registration statement be accelerated to 9:00 A.M. Eastern
Time on Monday, September 11, 2023, or as soon as practicable thereafter, pursuant to Rule 461 under the Securities Act. Wainwright affirms
that it is aware of its obligations under the Securities Act as they pertain to the best efforts offering pursuant to the Registration
Statement.
Very truly yours,
H.C. WAINWRIGHT & CO., LLC
By:
/s/
Edward D. Silvera
Name:
Edward D. Silvera
Title:
Chief Operating Officer
430
Park Avenue | New York, NY 10022 | 212.356.0500 | www.hcwco.com
Member:
FINRA/SIPC
2023-07-26 - UPLOAD - Cingulate Inc.
United States securities and exchange commission logo
July 26, 2023
Shane J. Schaffer
Chief Executive Officer
Cingulate Inc.
1901 W. 47th Place
Kansas City, KS 66205
Re:Cingulate Inc.
Registration Statement on Form S-1
Filed July 25, 2023
File No. 333-273405
Dear Shane J. Schaffer:
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: Tracy F. Buffer
2023-05-01 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
May
1, 2023
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
Mail
Stop 4720
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Cingulate
Inc.
Registration
Statement on Form S-1
File
No. 333-271455
Acceleration
Request
Requested
Date:
May
2, 2023
Requested
Time:
4:30
p.m., Eastern Time
Dear
Ladies and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Cingulate Inc. (the “Company”) hereby requests that the above-referenced
Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission (the
“Commission”) at the “Requested Date” and “Requested Time” set forth above or at such later time
as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Commission.
Please
call Steven M. Skolnick of Lowenstein Sandler LLP at (973) 597-2476 to confirm the effectiveness of the Registration Statement or with
any questions.
Sincerely,
CINGULATE
INC.
By:
/s/
Shane J. Schaffer
Name:
Shane
J. Schaffer
Title:
Chief
Executive Officer
2023-05-01 - UPLOAD - Cingulate Inc.
United States securities and exchange commission logo
May 1, 2023
Shane J. Schaffer
Chief Executive Officer
Cingulate Inc.
1901 W. 47th Place
Kansas City, KS 66205
Re:Cingulate Inc.
Registration Statement on Form S-1
Filed April 26, 2023
File No. 333-271455
Dear Shane J. Schaffer:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Steven M. Skolnick, Esq.
2023-01-11 - UPLOAD - Cingulate Inc.
United States securities and exchange commission logo
January 11, 2023
Shane J. Schaffer
Chief Executive Officer
Cingulate Inc.
1901 W. 47th Place
Kansas City, KS 66205
Re:Cingulate Inc.
Registration Statement on Form S-3
Filed January 3, 2023
File No. 333-269104
Dear Shane J. Schaffer:
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: Tracy F. Buffer
2023-01-11 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
January
11, 2023
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re: Cingulate
Inc. (the “Company”)
Registration
Statement on Form S-3 (File No. 333-269104)
Acceleration
Request
Requested
Date: January 13, 2023
Requested
Time: 4:05 p.m., Eastern Time
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Cingulate Inc. (the “Company”) hereby requests that the above-referenced
Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission at
the “Requested Date” and “Requested Time” set forth above or as soon as practicable thereafter, or at such later
time as the Company or its counsel may orally request via telephone call to the staff.
Please
call Steven M. Skolnick of Lowenstein Sandler LLP at (973) 597-2476 to confirm the effectiveness of the Registration Statement or with
any questions.
Sincerely,
CINGULATE
INC.
By:
/s/
Shane J. Schaffer
Name:
Shane
J. Shaffer
Title:
Chief
Executive Officer
2021-12-03 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
December
3, 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
Attn:
Dillon
Hagius
Re:
Cingulate
Inc.
Registration Statement on Form S-1, as amended
File No. 333-259408
Acceleration
Request
Requested
Date:
December
7, 2021
Requested
Time:
4:30
p.m. Eastern Time
Dear
Ladies and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Cingulate Inc. (the “Company”) hereby requests that the above-referenced
Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission (the
“Commission”) at the “Requested Date” and “Requested Time” set forth above or as soon as practicable
thereafter, or at such later time as the Company or its counsel may orally request via telephone call to the staff.
Please
call Steven M. Skolnick of Lowenstein Sandler LLP at (973) 597-2476 to confirm the effectiveness of the Registration Statement or with
any questions.
Sincerely,
CINGULATE
INC.
By:
/s/
Shane J. Schaffer
Name:
Shane
J. Shaffer
Title:
Chief
Executive Officer
2021-12-03 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
AEGIS
CAPITAL CORP.
December
3, 2021
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
DC 20549
RE:
Cingulate
Inc. (CIK: 0001862150)
Registration
Statement No. 333-259408 on Form S-1/A (the “Registration Statement”)
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as
amended (the “Securities Act”), Aegis Capital Corp. hereby requests acceleration of the effective date of the above-referenced
Registration Statement so that it will become effective at 4:30 p.m. Eastern Time, December 7, 2021, or as soon thereafter as practicable.
Pursuant
to Rule 460 under the Securities Act, please be advised that we will distribute as many electronic copies of the proposed form of preliminary
prospectus as appears to be reasonable to secure adequate distribution.
By:
AEGIS CAPITAL CORP.
By:
/s/
Robert Eide
Name:
Robert
Eide
Title:
Chairman
of the Board and Chief Executive Officer
2021-10-14 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
October
14, 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
Attn:
Dillon
Hagius
Re:
Cingulate
Inc.
Registration
Statement on Form S-1, as amended
File
No. 333-259408
Ladies
and Gentlemen:
Cingulate
Inc. hereby requests that its acceleration request dated October 12, 2021 be withdrawn. Please call Steven M. Skolnick of Lowenstein
Sandler LLP at (973) 597-2476 with any questions.
Sincerely,
CINGULATE
INC.
By:
/s/
Shane J. Schaffer
Name:
Shane
J. Shaffer
Title:
Chief
Executive Officer
2021-10-14 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
October
14, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Cingulate Inc.
Registration Statement on Form S-1
File No. 333-259408
Ladies
and Gentlemen:
Reference
is made to our letter, filed as correspondence via EDGAR on October 12, 2021, in which we, as representative of the several underwriters
of Cingulate Inc.’s proposed initial public offering of common stock, joined Cingulate Inc.’s request for acceleration of
the effective date of the above-referenced Registration Statement for Thursday, October 14, 2021, at 4:30 p.m. Eastern Time. Cingulate
Inc. is no longer requesting that such Registration Statement be declared effective at this time and we hereby formally withdraw our
request for acceleration of the effective date.
Very
truly yours,
OPPENHEIMER
& CO. INC.
As
representative of the
several
Underwriters
OPPENHEIMER
& CO. INC.
By:
/s/
Matthew Dormer
Name:
Matthew
Dormer
Title:
Managing
Director
2021-10-12 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
Oppenheimer
& Co. Inc.
85
Broad Street
New
York, New York 10004
October
12, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Cingulate
Inc.
Registration
Statement on Form S-1
File
No. 333-259408
Ladies
and Gentlemen:
In
accordance with the above-referenced Registration Statement, and pursuant to Rule 461 of the General Rules and Regulations of the Securities
and Exchange Commission under the Securities Act of 1933, as amended (the “Securities Act”), the undersigned, as the representative
of the several underwriters (the “Representative”), hereby joins in the request of Cingulate Inc. that the effective date
of the above-referenced Registration Statement be accelerated so that it will be declared effective at 4:30 p.m., Eastern Time, on Thursday,
October 14, 2021, or as soon thereafter as practicable.
Pursuant
to Rule 460 under 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 security, as many copies of the proposed form of preliminary prospectus
as appears to be reasonable to secure adequate distribution of the preliminary prospectus.
The
undersigned, as the representative of the several underwriters, represents that the several underwriters have and will comply with the
requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very
truly yours,
OPPENHEIMER
& CO. INC.
As
representative of the
several
Underwriters
OPPENHEIMER
& CO. INC.
By:
/s/
Michael Margolis R.Ph.
Name:
Michael Margolis
R.Ph.
Title:
Senior Managing Director,
Co-Head
Healthcare
Investment Banking
2021-10-12 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
October
12, 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
Attn:
Dillon
Hagius
Re:
Cingulate
Inc.
Registration
Statement on Form S-1, as amended
File
No. 333-259408
Acceleration
Request
Requested
Date: October 14, 2021
Requested
Time: 4:30 p.m. Eastern Time
Dear
Ladies and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Cingulate Inc. (the “Company”) hereby requests that the above-referenced
Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission (the
“Commission”) at the “Requested Date” and “Requested Time” set forth above or as soon as practicable
thereafter, or at such later time as the Company or its counsel may orally request via telephone call to the staff.
Please
call Steven M. Skolnick of Lowenstein Sandler LLP at (973) 597-2476 to confirm the effectiveness of the Registration Statement or with
any questions.
Sincerely,
CINGULATE
INC.
By:
/s/
Shane J. Schaffer
Name:
Shane
J. Shaffer
Title:
Chief
Executive Officer
2021-10-06 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
October
6, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Cingulate
Inc.
Registration
Statement on Form S-1
File
No. 333-259408
Ladies
and Gentlemen:
Reference is made to our letter, filed as correspondence via EDGAR on October 4, 2021, in which we, as representative of the several
underwriters of Cingulate Inc.’s proposed initial public offering of common stock, joined Cingulate Inc.’s request for
acceleration of the effective date of the above-referenced Registration Statement for Wednesday, October 6, 2021, at 4:00 p.m.
Eastern Time. Cingulate, Inc. is no longer requesting that such Registration Statement be declared effective at this time and we
hereby formally withdraw our request for acceleration of the effective date.
Very
truly yours,
OPPENHEIMER
& CO. INC.
As
representative of the
several
Underwriters
OPPENHEIMER & CO. INC.
By:
/s/
Matthew Dormer
Name:
Matthew Dormer
Title:
Managing Director
2021-10-06 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
October
6, 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
Attn:
Dillon
Hagius
Re:
Cingulate
Inc.
Registration
Statement on Form S-1, as amended
File
No. 333-259408
Ladies
and Gentlemen:
Cingulate
Inc. hereby requests that its acceleration request dated October 4, 2021 be withdrawn. Please call Steven M. Skolnick of Lowenstein Sandler
LLP at (973) 597-2476 with any questions.
Sincerely,
CINGULATE
INC.
By:
/s/
Shane J. Schaffer
Name:
Shane
J. Shaffer
Title:
Chief
Executive Officer
2021-10-04 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
Oppenheimer
& Co. Inc.
85
Broad Street
New
York, New York 10004
October
4, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Cingulate
Inc.
Registration
Statement on Form S-1
File
No. 333-259408
Ladies
and Gentlemen:
In
accordance with the above-referenced Registration Statement, and pursuant to Rule 461 of the General Rules and Regulations of the Securities
and Exchange Commission under the Securities Act of 1933, as amended (the “Securities Act”), the undersigned, as the representative
of the several underwriters (the “Representative”), hereby joins in the request of Cingulate Inc. that the effective date
of the above-referenced Registration Statement be accelerated so that it will be declared effective at 4:00 p.m., Eastern Time, on Wednesday,
October 6, 2021, or as soon thereafter as practicable.
Pursuant
to Rule 460 under 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 security, as many copies of the proposed form of preliminary prospectus
as appears to be reasonable to secure adequate distribution of the preliminary prospectus.
The
undersigned, as the representative of the several underwriters, represents that the several underwriters have and will comply with the
requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very
truly yours,
OPPENHEIMER
& CO. INC.
As
representative of the
several
Underwriters
OPPENHEIMER
& CO. INC.
By:
/s/
Matthew Dormer
Name:
Matthew
Dormer
Title:
Managing
Director
2021-10-04 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
October
4, 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
Attn:
Dillon
Hagius
Re:
Cingulate
Inc.
Registration
Statement on Form S-1, as amended
File
No. 333-259408
Acceleration
Request
Requested
Date:
October
6, 2021
Requested
Time:
4:00
p.m. Eastern Time
Dear
Ladies and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Cingulate Inc. (the “Company”) hereby requests that the above-referenced
Registration Statement (the “Registration Statement”) be declared effective by the Securities and Exchange Commission (the
“Commission”) at the “Requested Date” and “Requested Time” set forth above or as soon as practicable
thereafter, or at such later time as the Company or its counsel may orally request via telephone call to the staff.
Please
call Steven M. Skolnick of Lowenstein Sandler LLP at (973) 597-2476 to confirm the effectiveness of the Registration Statement or with
any questions.
Sincerely,
CINGULATE
INC.
By:
/s/
Shane J. Schaffer
Name:
Shane
J. Shaffer
Title:
Chief
Executive Officer
2021-10-01 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
October 1, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
Mail
Stop 3030
Washington,
DC 20549
Attn:
Dillon
Hagius
Laura
Crotty
Gary
Newberry
Daniel
Gordon
Re:
Cingulate
Inc.
Amendment
No. 1 Registration Statement on Form S-1
Filed
September 27, 2021
File
No. 333-259408
Ladies
and Gentlemen:
On
behalf of Cingulate Inc. (the “Company”), we are hereby responding to the letter, dated September 30, 2021 (the “Comment
Letter”), from the staff (the “Staff”) of the Division of Corporation Finance, Office of Life Sciences, of the Securities
and Exchange Commission (the “Commission”), regarding the Company’s Amendment No.1 to Draft Registration Statement
on Form S-1, filed on September 27, 2021 (the “Registration Statement”). In response to the Comment Letter and to update
certain information in the Registration Statement, the Company is filing a registration statement (the “Revised Registration Statement”).
For ease of reference, set forth below in bold are the comments of the Staff with respect to the Registration Statement, as reflected
in the Comment Letter. The Company’s response is set forth below each comment. Capitalized terms used herein have the meanings
set forth in the Registration Statement unless defined herein.
The
Company has authorized us to respond to the Comment Letter as follows:
Stock
Dividend, page 6
1.
We
note the new disclosure included throughout the prospectus regarding a Stock Dividend payable prior to the effective date of the
registration statement. We also note the risk factor on page 56 which states that the company has never declared or paid any dividends
on its common stock and currently intends to retain all available funds and any future earnings, if any, to fund the development
and expansion of its business, with no plans to pay any cash dividends in the foreseeable future. Please expand your disclosure to
quantify the estimated total number of shares payable pursuant to the Stock Dividend, address the dilution effects, if any, and explain
the board’s reasoning for declaring the dividend at this time.
Response:
The Company respectfully acknowledges the Staff’s comment and has included the requested disclosure in the Revised Registration
Statement.
Any
questions regarding the contents of this letter or the Revised Registration Statement should be addressed to the undersigned at (973)
597-2476.
Very
truly yours,
/s/
Steven M. Skolnick
Steven
M. Skolnick
cc:
Shane
J. Schaffer, Cingulate Inc.
2021-09-30 - UPLOAD - Cingulate Inc.
United States securities and exchange commission logo
September 30, 2021
Shane Schaffer
Chief Executive Officer
Cingulate Inc.
1901 W. 47th Place
Kansas City, KS 66205
Re:Cingulate Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed September 27, 2021
File No. 333-259408
Dear Mr. Schaffer:
We have reviewed your amended registration statement and have the following
comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to this comment, we may have additional comments.
Amendment No. 1 to Form S-1 filed September 27, 2021
Stock Dividend, page 6
1.We note the new disclosure included throughout the prospectus regarding a Stock
Dividend payable prior to the effective date of the registration statement. We also note
the risk factor on page 56 which states that the company has never declared or paid any
dividends on its common stock and currently intends to retain all available funds and any
future earnings, if any, to fund the development and expansion of its business, with no
plans to pay any cash dividends in the foreseeable future. Please expand your disclosure
to quantify the estimated total number of shares payable pursuant to the Stock Dividend,
address the dilution effects, if any, and explain the board's reasoning for declaring the
dividend at this time.
FirstName LastNameShane Schaffer
Comapany NameCingulate Inc.
September 30, 2021 Page 2
FirstName LastName
Shane Schaffer
Cingulate Inc.
September 30, 2021
Page 2
You may contact Gary Newberry at 202-551-3761 or Daniel Gordon at 202-551-3486 if
you have questions regarding comments on the financial statements and related matters. Please
contact Dillon Hagius at 202-551-7967 or Laura Crotty at 202-551-7614 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Steven Skolnick
2021-09-09 - CORRESP - Cingulate Inc.
CORRESP
1
filename1.htm
T:
973 597 2476
F:
973 597 2477
E:
sskolnick@lowenstein.com
September
9, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
Mail
Stop 3030
Washington,
DC 20549
Attn:
Dillon
Hagius
Laura
Crotty
Gary
Newberry
Daniel
Gordon
Re:
Cingulate
Inc.
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted
August 13, 2021
CIK
No. 0001862150
Ladies
and Gentlemen:
On
behalf of Cingulate Inc. (the “Company”), we are hereby responding to the letter, dated August 17, 2021 (the “Comment
Letter”), from the staff (the “Staff”) of the Division of Corporation Finance, Office of Life Sciences, of the Securities
and Exchange Commission (the “Commission”), regarding the Company’s Amendment No. 2 to Draft Registration Statement
on Form S-1, submitted on August 13, 2021 (the “Draft Registration Statement”). In response to the Comment Letter and to
update certain information in the Draft Registration Statement, the Company is filing a registration statement (the “Revised Registration
Statement”). For ease of reference, set forth below in bold are the comments of the Staff with respect to the Draft Registration
Statement, as reflected in the Comment Letter. The Company’s response is set forth below each comment. Capitalized terms used herein
have the meanings set forth in the Draft Registration Statement unless defined herein.
The
Company has authorized us to respond to the Comment Letter as follows:
Business
Recently
Launched Products Lack Meaningful Clinical Innovation, page 83
1.
Please
disclose the source of all information contained in the above entitled chart on page 83.
Response:
The Company respectfully acknowledges the Staff’s comment and has included the requested disclosure on page 83.
Any
questions regarding the contents of this letter or the Revised Registration Statement should be addressed to the undersigned at (973)
597-2476.
Very
truly yours,
/s/
Steven M. Skolnick
Steven
M. Skolnick
cc:
Shane
J. Schaffer, Cingulate Inc.
2021-08-17 - UPLOAD - Cingulate Inc.
United States securities and exchange commission logo
August 17, 2021
Shane Schaffer
Chief Executive Officer
Cingulate Inc.
1901 W. 47th Place
Kansas City, KS 66205
Re:Cingulate Inc.
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted August 13, 2021
CIK No. 0001862150
Dear Mr. Schaffer:
We have reviewed your amended draft registration statement and have the following
comment.
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 this comment and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 2 to Draft Registration Statement on Form S-1 submitted August 13, 2021
Business
Recently Launched Products Lack Meaningful Clinical Innovation, page 83
1.Please disclose the source of all information contained in the above entitled chart on page
83.
You may contact Gary Newberry at 202-551-3761 or Daniel Gordon at 202-551-3486 if
you have questions regarding comments on the financial statements and related matters. Please
contact Dillon Hagius at 202-551-7967 or Laura Crotty at 202-551-7614 with any other
questions.
FirstName LastNameShane Schaffer
Comapany NameCingulate Inc.
August 17, 2021 Page 2
FirstName LastName
Shane Schaffer
Cingulate Inc.
August 17, 2021
Page 2
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Steven Skolnick
2021-07-28 - UPLOAD - Cingulate Inc.
United States securities and exchange commission logo
July 28, 2021
Shane Schaffer
Chief Executive Officer
Cingulate Inc.
1901 W. 47th Place
Kansas City, KS 66205
Re:Cingulate Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted July 19, 2021
CIK No. 0001862150
Dear Mr. Schaffer:
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. 2 to Draft Registration Statement
Prospectus Summary
Our Clinical Development Pipeline, page 2
1.We note your response to comment 2. As it concerns CTx-1302 in your pipeline table,
please remove the Phase 3 initiation as an anticipated milestone. In this regard, we re-
assert our prior request that you only provide the anticipated milestone for the next trial
(e.g., a phase 1/2 trial), rather than listing all future phases. Relatedly, please remove the
statement in the amended pipeline table that "Phase 3 Trials to be initiated upon successful
outcome of Phase 1/2BA Trial" because it improperly implies that this trial will be
successful.
FirstName LastNameShane Schaffer
Comapany NameCingulate Inc.
July 28, 2021 Page 2
FirstName LastName
Shane Schaffer
Cingulate Inc.
July 28, 2021
Page 2
Business
Cingulate's Product Candidates versus Major ADHD Competitors (>75% of the ADHD Market),
page 82
2.We note your response to comment 16 and reissue the comment. Please remove both
charts from this page. As neither CTx-1301 nor CTx-1302 have completed clinical
trials, the information provided in the first two rows of each table is unsupported and
therefore the tabular comparison to competitors' products is inappropriate.
Our CTx-1301 Clinical Development Program, page 86
3.We note your response to comment 17 and related amendment on page 89 that you "plan
to initiate the additional Phase 1 studies concurrently with our Phase 3 Mastery studies."
Please clarify whether your Planned Phase 3 Mastery Study will be impacted by the
results of these two Phase 1 studies.
Figure 3: Comparative Bioavailability Study of CTx-1301 versus Focalin XR in individual Adult
ADHD subjects under Fasted Conditions , page 89
4.We note your response to comment 19 and reissue the comment, as it does not appear that
this figure was changed. Please advise or revise.
You may contact Gary Newberry at 202-551-3761 or Daniel Gordon at 202-551-3486 if
you have questions regarding comments on the financial statements and related matters. Please
contact Dillon Hagius at 202-551-7967 or Laura Crotty at 202-551-7614 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Steven Skolnick
2021-06-17 - UPLOAD - Cingulate Inc.
United States securities and exchange commission logo
June 17, 2021
Shane Schaffer
Chief Executive Officer
Cingulate Inc.
1901 W. 47th Place
Kansas City, KS 66205
Re:Cingulate Inc.
Draft Registration Statement on Form S-1
Submitted May 24, 2021
CIK No. 0001862150
Dear Mr. Schaffer:
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
Cover Page
1.To facilitate an understanding of the transaction, please prominently identify the
reorganization and related agreements as an “Up-C” transaction. This should also be
stated elsewhere in the prospectus where the transactions are discussed. In addition,
please expand your disclosure to explain the material ways in which the structure benefits
the company and other related parties. Conflicts of interest related to such benefits should
be discussed in the Summary and Risk Factors section.
FirstName LastNameShane Schaffer
Comapany NameCingulate Inc.
June 17, 2021 Page 2
FirstName LastNameShane Schaffer
Cingulate Inc.
June 17, 2021
Page 2
Basis of Presentation, page ii
2.The pro forma condensed consolidated financial data you refer to appears to relate to the
presentation of capitalization and dilution sections of this submission. Please provide a
pro forma condensed balance sheet and pro forma condensed statements of comprehensive
income for the latest annual and interim periods presented to illustrate how the
organizational transactions described on page 69 will impact the historical financial
statements. As a smaller reporting company, you may refer to Article 11 of Regulation S-
X for guidance.
Prospectus Summary
Overview, page 1
3.Please balance your Summary disclosure by discussing the competitive landscape
applicable to your product candidates and the uncertainty surrounding the performance of
your product candidates in clinical trials, given the stage of development of each.
4.Please make the following revisions, both in the Summary Overview and throughout the
prospectus where similar statements or claims are made:
•Remove statements that your October 2020 Phase 1/2 trial of CTx-1301 in ADHD
patients established "safety" of CTx-1301, as safety and efficacy determinations are
the exclusive purview of the the FDA or other regulators;
•Remove statements that CTx-1301 is a "late-stage asset," as this implies that the
product is farther into the development process than it really is;
•Remove statements that you plan to initiate Phase 3 trials for CTx-1302 in 2022, as
this statement presumes that your Phase 1/2a trials will be successful;
•Remove statement that you plan to submit new drug applications for CTx-1301 and
CTx-1302 in the first half of 2023 and in 2024, respectively, as this statement
presumes that your Phase 3 trials will be successful.
Please ensure that similar statements on page 94 are also revised or removed.
Our Clinical Development Pipeline , page 2
5.Please make the following revisions to your pipeline table on pages 2 and 95:
•Provide two separate columns for Phases 1 and 2;
•For CTx-1302, only provide the anticipated milestone for the next trial (e.g., a phase
1/2 trial) rather than listing all future phases;
•Provide a footnote to explain the use of the trademarks "Mastery" and "Accomplish"
in the Anticipated Milestones column;
•Remove the shaded orange arrows so the only progress arrows included accurately
depict the progression of development achieved for each product candidate to date.
The table should be a reflection of the narrative disclosure in the prospectus and
should not be used to prematurely project successful completion of the stages
required prior to commercialization.
•Combine the "PTR Platform Proof of Concept" column and the "Formulation
FirstName LastNameShane Schaffer
Comapany NameCingulate Inc.
June 17, 2021 Page 3
FirstName LastNameShane Schaffer
Cingulate Inc.
June 17, 2021
Page 3
Development" columns, as both relate to pre-clinical development. Additional
columns should not be added to the pipeline table to create the impression of further
progress. Note that we will not object to pre-clinical stage columns labeled as
"discovery" and/or "IND-enabling."
Our Proprietary Precision Timed Release Drug Delivery Platform Technology, page 3
6.We note your disclosure here and throughout the filing that you believe your timed release
drug delivery platform technology will "lower abuse potential" because it will "eliminate[]
the need for a second stimulate dose." This statement appears to be incomplete, as
you state on page two that "CTx-1301 and CTx-1302 product candidates both contain 3
doses of active pharmaceutical ingredient combined into one small tablet." Please ensure
that any statements concerning "lower abuse potential" are properly balanced with
disclosure that that one dose of CTx-1301 or CTx-1302 is the equivalent of three doses of
other Schedule II stimulants.
Our Strategy, page 4
7.We note your disclosure that you intend to "[r]apidly advance through clinical trials and
eventually obtain regulatory approval for CTx-2103 for the treatment of anxiety." Please
revise this disclosure to remove any implication that you will be successful in
commercializing your product candidates in an accelerated manner, as such statements are
speculative and outside of the company's control given the extensive regulatory process
and approvals required. Ensure that similar language throughout the prospectus is also
removed.
Our Organizational Structure, page 7
8.Please disclose in this summary section that CTx's shares of Class B common stock will
allow it to exercise voting power over Cingulate Inc. at a level that is greater than its
overall equity ownership of your business. We note disclosure to this effect on page 72.
9.Please enlarge the post-reorganization charts to ensure the font is legible and include
estimated ownership percentages for each branch as you have done in the pre-
reorganization chart on page 71.
Risk Factors
We are a development stage biopharmaceutical company with a limited operating history., page
14
10.Your disclosure that you are a "development stage" company contradicts your disclosure
on page 1 that you are a clinical stage company. Please revise.
FirstName LastNameShane Schaffer
Comapany NameCingulate Inc.
June 17, 2021 Page 4
FirstName LastNameShane Schaffer
Cingulate Inc.
June 17, 2021
Page 4
Risks Related to Development, Clinical Testing, Manufacturing and Regulatory Approval, page
18
11.Please provide expanded risk factor disclosure concerning the clinical trial risks associated
with pediatric trials. We note that two of the three segments for which CTx-1301 and
CTx-1302 are being developed are for children (ages 6 -12) and adolescents (ages 13-17).
We rely and expect to continue to rely completely on third parties to formulate and manufacture
our preclinical, clinical trial..., page 37
12.Your disclosure that you "have no experience in drug formulation or manufacturing"
appears to contradict your disclosure on page 4 that your "founders and management team
have many years of experience in the biopharmaceutical space" and possess "substantial
experience and expertise across the spectrum of drug development and commercialization
of pharmaceutical products[.]" This disclosure also appears to contradict your disclosures
on page 96 that you want to "[c]apitalize on our existing cGMP Manufacturing Expertise"
and that you "have developed a proprietary, reliable, high output, specialized
manufacturing equipment train with the potential for real-time testing and release." Please
advise and revise.
Industry And Other Data , page 67
13.Your statement that investors are cautioned not to give undue weight to the market and
industry data used in the prospectus may imply an inappropriate disclaimer of
responsibility with respect to the third party information. Please either delete these
statements or specifically state that you are liable for such information.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Liquidity and Capital Resources, page 90
14.Please revise your liquidity disclosures to address the Tax Receivable Agreement,
disclosing your estimates of annual payments and how you intend to fund the required
payments under the agreement. In this regard, we note your statements that you expect the
future payments under the agreement may be substantial. This information should also be
disclosed in the Summary and in the Risk Factors.
Business
Our Strategy , page 96
15.Please remove the statement that you "plan to initiate pivotal Phase 3 clinical trials in all
patient segments for CTx-1302 in late 2022 with results expected in early 2024. Assuming
we receive positive clinical results from our Phase 1/2 bioavailability study, our pivotal
Phase 3 trials and additional planned supplementary trials, we plan to submit an NDA for
CTx-1302 in the second half of 2024 under the Section 505(b)(2) pathway." Given that
you will not initiate a Phase1/2 bioavailability study in ADHD patients until 2022, these
FirstName LastNameShane Schaffer
Comapany NameCingulate Inc.
June 17, 2021 Page 5
FirstName LastNameShane Schaffer
Cingulate Inc.
June 17, 2021
Page 5
statements are premature and speculative. Additionally, remove the statement that your
manufacturing "process has been designed and proven with CTx-1301," as efficacy
determinations are the exclusive purview of the FDA or other regulators.
Cingulate's Product Candidates versus Major ADHD Competitors (>75% of the ADHD Market),
page 100
16.Please remove the chart entitled "Cingulate's Product Candidates versus Major ADHD
Competitors (>75% of the ADHD Market)" from the prospectus. It is inappropriate to
provide projected approval dates for the company's product candidates, as these
determinations are solely within the purview of the FDA and out of the company's control.
In addition, because the company has not conducted head to head studies with the
competing products listed, nor has either candidate completed clinical trials, it is
inappropriate to present the information as if they have been directly compared and
studied.
Our CTx-1301 Clinical Development Program, page 104
17.You note that the proposed clinical program for CTx-1301 consists of three Phase 1
clinical pharmacology studies, but you only report the findings from one Phase 1/2
Bioavailability Trial. Please provide more information about all of these trials including
their underlying protocols and results. We also note that you disclose on page one
that CTx-1301 is being developed for three main patient segments (children ages 6 -12,
adolescents ages 13-17, and adults ages 18+), but that this section does not provide any
additional information about the trial results for each of these segments. Please revise or
explain.
18.We note the following statement on page 104: "There were no unexpected adverse events,
serious adverse events, deaths, or other safety signals." The statement as drafted may be
construed to mean that SAEs or deaths occurred as a result of the Phase 1/2 study, but
were expected. Please revise to clarify and provide detail regarding any material events.
Figure 3: Comparative Bioavailability Study of CTx-1301 versus Focalin XR in individual Adult
ADHD subjects under Fasted Conditions. . ., page 107
19.The font in this figure is too small to be legible. Please enlarge. Additionally, please
revise this chart to better clarify whether each of your individual conclusions in these four
charts (e.g. "eliminate booster dose" or "stop crash & rebound") applies to both the low
and high dose trials or only to a specific trial. As written, it appears that only the lower
dose trial concluded that it could "eliminate booster dose" and only the high dose trial
concluded that it could "stop crash & rebound."
Our CTx-1302 Clinical Development Program, page 109
20.We note your statements on page 107 and 109 that you "plan to initiate Phase 1, 2 and 3
FirstName LastNameShane Schaffer
Comapany NameCingulate Inc.
June 17, 2021 Page 6
FirstName LastNameShane Schaffer
Cingulate Inc.
June 17, 2021
Page 6
trials in 2022 and to file an NDA in 2024" and "plan to initiate Phase 3 trials in the fourth
quarter of 2021 and to file an NDA in the first half of 2023". In addition, you
reference your correspondence with the FDA and state that you believe that the proposed
clinical programs and trials "will fulfill the clinical developmental program requirements
thus allowing us to seek approval for the treatment of ADHD in patients 6 years and
older." Please revise these statements, as they are speculative and premature.
Our Planned Phase 3 ACCOMPLISH Trials, page 110
21.Please clarify that you will only undertake these Phase 3 trials for CTx-1302 should the
data from the Phase 1 and Phase 2 trials support continued Phase 3 testing.
Intellectual Property, page 112
22.Please revise your intellectual property disclosure to clearly describe on an individual or
patent family basis the type of patent protection granted for each technology, the
expiration of each patent held, and the jurisdiction of each patent. In this regard, it may be
useful to provide this disclosure in tabular form to support the narrative already included.
Patent and Know-How License Agreement with BDD Pharma Limited, page 132
23.Please revise your disclosure concerning the BDD license agreement to disclose the
expected expiry of the last-to-expire patent licensed under the agreements or the expected
last-to-expire payment obligations.
Executive Compensation
Summary Compensation Table, page 139
24.We note the introduction to the Summary Compensation Table states that the table
provides compensation information for the fiscal years ended December 31, 2020 and
2019. However, the table only includes information for 2020. Please revise to include
2019 or explain why such information has been omitted.
Certain Relationships and Related Party Transactions, page 148
25.We note your use of the defined term "Redeemed Members" in this section and
throughout the filing, and your statement on page 6 that the Redeemed Members are
"certain of [the company's] historical members". Please revise, where appropriate, to
identify the members by name. In addition, we note your discussion of a $500,000
promissory note issued to a "Member of the Company". Please identify the member by
name. See Item 404(a)(1) of Regulation S-K. Finally, please provide your analysis as to
why the related party notes have not been filed as exhibits to the registration statement.
Notes to Consolidated Financial Statements
Note 8 - Profits Interest Plan, page F-16
26.You state on page 87 that a future event, such as a public offering, would create a
FirstName LastNameShane Schaffer
Comapany NameCingulate Inc.
June 17, 2021 Page 7
FirstName LastName
Shane Schaffer
Cingulate Inc.
June 17, 2021
Page 7
modification of the PIUs issued under the Cingulate Therapeutics LLC Equity Incentive
Plan. Please tell us:
•what modifications the Plan would call for, including any requirement to convert the
PIUs into options to purchase shares of Class A common stock, and
•what terms, if any, are required for a public offering in order to require modification
of the