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Unicycive Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
↓
Unicycive Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
↓
Company responded
2024-11-18
Unicycive Therapeutics, Inc.
Filing - Correspondence from Unicycive Therapeutics, Inc.
CORRESP · 2024-11-18
Generating summary...
Unicycive Therapeutics, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2024-07-08
Unicycive Therapeutics, Inc.
Filing - SEC Comment Letter to Unicycive Therapeutics, Inc.
UPLOAD · 2024-07-08
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↓
Company responded
2024-07-11
Unicycive Therapeutics, Inc.
Filing - Correspondence from Unicycive Therapeutics, Inc.
CORRESP · 2024-07-11
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Unicycive Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
↓
Company responded
2023-08-01
Unicycive Therapeutics, Inc.
Filing - Correspondence from Unicycive Therapeutics, Inc.
CORRESP · 2023-08-01
Generating summary...
Unicycive Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-08-22
Unicycive Therapeutics, Inc.
Filing - SEC Comment Letter to Unicycive Therapeutics, Inc.
UPLOAD · 2022-08-22
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↓
Company responded
2022-08-22
Unicycive Therapeutics, Inc.
Filing - Correspondence from Unicycive Therapeutics, Inc.
CORRESP · 2022-08-22
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Unicycive Therapeutics, Inc.
Response Received
10 company response(s)
High - file number match
SEC wrote to company
2021-06-03
Unicycive Therapeutics, Inc.
Filing - SEC Comment Letter to Unicycive Therapeutics, Inc.
UPLOAD · 2021-06-03
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↓
Company responded
2021-06-07
Unicycive Therapeutics, Inc.
Filing - Correspondence from Unicycive Therapeutics, Inc.
CORRESP · 2021-06-07
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↓
Company responded
2021-06-14
Unicycive Therapeutics, Inc.
Filing - Correspondence from Unicycive Therapeutics, Inc.
CORRESP · 2021-06-14
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Company responded
2021-06-14
Unicycive Therapeutics, Inc.
Filing - Correspondence from Unicycive Therapeutics, Inc.
CORRESP · 2021-06-14
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Company responded
2021-06-22
Unicycive Therapeutics, Inc.
Filing - Correspondence from Unicycive Therapeutics, Inc.
CORRESP · 2021-06-22
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Company responded
2021-06-23
Unicycive Therapeutics, Inc.
Filing - Correspondence from Unicycive Therapeutics, Inc.
CORRESP · 2021-06-23
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Company responded
2021-07-06
Unicycive Therapeutics, Inc.
Filing - Correspondence from Unicycive Therapeutics, Inc.
CORRESP · 2021-07-06
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↓
Company responded
2021-07-06
Unicycive Therapeutics, Inc.
Filing - Correspondence from Unicycive Therapeutics, Inc.
CORRESP · 2021-07-06
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↓
Company responded
2021-07-07
Unicycive Therapeutics, Inc.
Filing - Correspondence from Unicycive Therapeutics, Inc.
CORRESP · 2021-07-07
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↓
Company responded
2021-07-08
Unicycive Therapeutics, Inc.
Filing - Correspondence from Unicycive Therapeutics, Inc.
CORRESP · 2021-07-08
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↓
Company responded
2021-07-08
Unicycive Therapeutics, Inc.
Filing - Correspondence from Unicycive Therapeutics, Inc.
CORRESP · 2021-07-08
Generating summary...
Unicycive Therapeutics, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2021-05-10
Unicycive Therapeutics, Inc.
Filing - SEC Comment Letter to Unicycive Therapeutics, Inc.
UPLOAD · 2021-05-10
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↓
Company responded
2021-05-21
Unicycive Therapeutics, Inc.
Filing - Correspondence from Unicycive Therapeutics, Inc.
CORRESP · 2021-05-21
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Unicycive Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-03-17
Unicycive Therapeutics, Inc.
Filing - SEC Comment Letter to Unicycive Therapeutics, Inc.
UPLOAD · 2021-03-17
Generating summary...
Unicycive Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2020-11-10
Unicycive Therapeutics, Inc.
Filing - SEC Comment Letter to Unicycive Therapeutics, Inc.
UPLOAD · 2020-11-10
Generating summary...
Unicycive Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2020-10-09
Unicycive Therapeutics, Inc.
Filing - SEC Comment Letter to Unicycive Therapeutics, Inc.
UPLOAD · 2020-10-09
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-06-11 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | 333-296545 | Read Filing View |
| 2026-06-11 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-11-18 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-11-14 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | 333-283210 | Read Filing View |
| 2024-07-11 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-07-08 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | 333-280703 | Read Filing View |
| 2023-08-01 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-07-19 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-08-22 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-08-22 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-08 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-08 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-07 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-06 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-06 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-23 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-22 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-14 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-14 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-07 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-03 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-05-21 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-05-10 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-03-17 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-11-10 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-09 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-06-11 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | 333-296545 | Read Filing View |
| 2024-11-14 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | 333-283210 | Read Filing View |
| 2024-07-08 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | 333-280703 | Read Filing View |
| 2023-07-19 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-08-22 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-03 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-05-10 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-03-17 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-11-10 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-10-09 | SEC Comment Letter | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-06-11 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-11-18 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-07-11 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-08-01 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-08-22 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-08 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-08 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-07 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-06 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-07-06 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-23 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-22 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-14 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-14 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-06-07 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-05-21 | Company Response | Unicycive Therapeutics, Inc. | DE | N/A | Read Filing View |
2026-06-11 - UPLOAD - Unicycive Therapeutics, Inc. File: 333-296545
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> June 11, 2026 Shalabh Gupta Chief Executive Officer Unicycive Therapeutics, Inc. 1975 W. El Camino Real, Suite 204 Mountain View, CA 94040 Re: Unicycive Therapeutics, Inc. Registration Statement on Form S-3 Filed June 5, 2026 File No. 333-296545 Dear Shalabh Gupta: 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: Greg Carney, Esq. </TEXT> </DOCUMENT>
2026-06-11 - CORRESP - Unicycive Therapeutics, Inc.
CORRESP 1 filename1.htm Unicycive Therapeutics, Inc. 1975 W. El Camino Real, Suite 204 Mountain View, CA 94040 June 11, 2026 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Tyler Howes Re: Unicycive Therapeutics, Inc. Registration Statement on Form S-3 Filed June 5, 2026 File No. 333-296545 Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended (the "Act"), Unicycive Therapeutics, Inc. (the "Company") respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective at 5:00 p.m., Eastern Daylight Time, on Monday, June 15, 2026, or as soon thereafter as possible. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Please notify Greg Carney of Sheppard Mullin Richter & Hampton LLP, counsel to the Company, at (213) 617-4209 as soon as possible as to the time the registration statement has been declared effective pursuant to this acceleration request. Very truly yours, UNICYCIVE THERAPEUTICS, INC. By: /s/ Shalabh Gupta Name: Shalabh Gupta Title: Chief Executive Officer cc: Greg Carney, Sheppard Mullin Richter & Hampton LLP
2024-11-18 - CORRESP - Unicycive Therapeutics, Inc.
CORRESP
1
filename1.htm
Unicycive Therapeutics, Inc.
4300 El Camino Real, Suite 210
Los Altos, CA 94022
November 18, 2024
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Tim Buchmiller
Re: Unicycive Therapeutics, Inc.
Registration Statement on Form S-3
File No. 333-283210
Filed November 13, 2024
Ladies and Gentlemen:
Pursuant to Rule 461 of the
General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Unicycive Therapeutics, Inc.
(the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated
so that it will become effective at 5:00 p.m., Eastern Daylight Time, on Wednesday, November 20, 2024, or as soon thereafter as possible.
In making this acceleration request, the Company acknowledges that it is aware of its responsibilities
under the Act.
Please notify Jeffrey Fessler
of Sheppard Mullin Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the registration
statement has been declared effective pursuant to this acceleration request.
Very truly yours,
UNICYCIVE THERAPEUTICS, INC.
By:
/s/ Shalabh Gupta
Name:
Shalabh Gupta
Title:
Chief Executive Officer
cc: Jeffrey Fessler, Sheppard Mullin Richter & Hampton LLP
2024-11-14 - UPLOAD - Unicycive Therapeutics, Inc. File: 333-283210
November 14, 2024
Shalabh Gupta, M.D.
Chief Executive Officer
Unicycive Therapeutics, Inc.
4300 El Camino Real, Suite 210
Los Altos, CA 94022
Re:Unicycive Therapeutics, Inc.
Registration Statement on Form S-3
Filed November 13, 2024
File No. 333-283210
Dear Shalabh Gupta M.D.:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tim Buchmiller at 202-551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Jeffrey J. Fessler, Esq.
2024-07-11 - CORRESP - Unicycive Therapeutics, Inc.
CORRESP
1
filename1.htm
Unicycive Therapeutics, Inc.
4300 El Camino Real, Suite 210
Los Altos, CA 94022
July 11, 2024
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Joshua Gorsky
Re:
Unicycive Therapeutics, Inc.
Registration Statement on Form S-3
File No. 333- 280703
Filed July 5, 2024
Ladies and Gentlemen:
Pursuant to Rule 461
of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Unicycive Therapeutics,
Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated
so that it will become effective at 9:00 a.m., Eastern Daylight Time, on Tuesday, July 16, 2024, or as soon thereafter as possible.
In making this acceleration request, the Company acknowledges that it is aware of its responsibilities
under the Act.
Please notify Jeffrey Fessler
of Sheppard Mullin Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the registration
statement has been declared effective pursuant to this acceleration request.
Very truly yours,
UNICYCIVE THERAPEUTICS, INC.
By:
/s/ Shalabh Gupta
Name:
Shalabh Gupta
Title:
Chief Executive Officer
cc: Jeffrey Fessler, Sheppard Mullin
Richter & Hampton LLP
2024-07-08 - UPLOAD - Unicycive Therapeutics, Inc. File: 333-280703
July 8, 2024
Shalabh Gupta
Chief Executive Officer
Unicycive Therapeutics, Inc.
4300 El Camino Real, Suite 210
Los Altos, CA 94022
Re:Unicycive Therapeutics, Inc.
Registration Statement on Form S-3
Filed July 5, 2024
File No. 333-280703
Dear Shalabh Gupta:
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:Jeffrey J. Fessler, Esq.
2023-08-01 - CORRESP - Unicycive Therapeutics, Inc.
CORRESP
1
filename1.htm
Unicycive Therapeutics, Inc.
4300 El Camino Real, Suite 210
Los Altos, CA 94022
August 1, 2023
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Alan Campbell
Re: Unicycive Therapeutics, Inc.
Registration Statement on Form S-3
File No. 333-273221
Filed July 13, 2023
Ladies and Gentlemen:
Pursuant to Rule 461
of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Unicycive Therapeutics,
Inc. (the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated
so that it will become effective at 9:00 a.m., Eastern Daylight Time, on Thursday, August 3, 2023, or as soon thereafter as possible.
In making this acceleration request, the Company acknowledges that it is aware of its responsibilities
under the Act.
Please notify Jeffrey Fessler
of Sheppard Mullin Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the registration
statement has been declared effective pursuant to this acceleration request.
Very truly yours,
UNICYCIVE THERAPEUTICS, INC.
By:
/s/ Shalabh Gupta
Name:
Shalabh Gupta
Title:
Chief Executive Officer
cc: Jeffrey Fessler, Sheppard Mullin Richter & Hampton LLP
2023-07-19 - UPLOAD - Unicycive Therapeutics, Inc.
United States securities and exchange commission logo
July 19, 2023
Shalabh Gupta
Chief Executive Officer
Unicycive Therapeutics, Inc.
4300 El Camino Real, Suite 210
Los Altos, CA 94022
Re:Unicycive Therapeutics, Inc.
Registration Statement on Form S-3
Filed July 13, 2023
File No. 333-273221
Dear Shalabh Gupta:
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: Jeffrey J. Fessler, Esq.
2022-08-22 - UPLOAD - Unicycive Therapeutics, Inc.
United States securities and exchange commission logo
August 22, 2022
Shalabh Gupta, M.D.
Chief Executive Officer
Unicycive Therapeutics, Inc.
4300 El Camino Real, Suite 210
Los Altos, CA 94022
Re:Unicycive Therapeutics, Inc.
Registration Statement on Form S-3
Filed August 16, 2022
File No. 333-266890
Dear Dr. Gupta:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Christine Westbrook at 202-551-5019 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey Fessler, Esq.
2022-08-22 - CORRESP - Unicycive Therapeutics, Inc.
CORRESP
1
filename1.htm
Unicycive
Therapeutics, Inc.
4300 El Camino Real, Suite 210
Los Altos, CA 94022
August 22, 2022
VIA EDGAR
United States Securities
and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Christine Westbrook
Re: Unicycive
Therapeutics, Inc.
Form S-3
File No. 333-266890
Ladies and Gentlemen:
Pursuant to Rule 461 of
the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), Unicycive Therapeutics, Inc. (the
“Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated so
that it will become effective at 4:00 p.m., Eastern Daylight Time, on Wednesday, August 24, 2022, or as soon thereafter as possible.
Please notify Jeffrey Fessler
of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (212) 634-3067 as soon as possible as to the time the
Registration Statement has been declared effective pursuant to this acceleration request.
Thank you,
UNICYCIVE THERAPEUTICS, INC.
By:
/s/ Shalabh Gupta
Name:
Title:
Shalabh Gupta
Chief Executive Officer
2021-07-08 - CORRESP - Unicycive Therapeutics, Inc.
CORRESP
1
filename1.htm
Unicycive
Therapeutics, Inc.
5150
El Camino Real, Suite A-32
Los
Altos, CA 94022
July
8, 2021
VIA
EDGAR
United
States Securities and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Jeffrey Gabor
Re:
Unicycive Therapeutics, Inc.
Registration Statement on Form S-1
Filed May 21, 2021
File No. 333-256367
Ladies
and Gentlemen:
Pursuant
to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Unicycive Therapeutics, Inc.
(the “Company”) respectfully requests that the effective date of the registration statement referred to above be accelerated
so that it will become effective at 5:00 p.m., Eastern Daylight Time, on Monday, July 12, 2021, or as soon thereafter as possible.
Please
notify Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (201) 669-0478 as soon as possible
as to the time the Registration Statement has been declared effective pursuant to this acceleration request.
UNICYCIVE THERAPEUTICS, INC.
By:
/s/
Shalabh Gupta
Name:
Shalabh Gupta
Title:
Chief Executive Officer
2021-07-08 - CORRESP - Unicycive Therapeutics, Inc.
CORRESP
1
filename1.htm
July
8, 2021
Via EDGAR Submission
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Re: UNICYCIVE
THERAPEUTICS, INC. (the “Company”)
Registration
Statement on Form S-1
CIK
No. 00001766140
SEC
Registration No. 333-256367
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), the undersigned, as underwriters of the
proposed offering, hereby joins the request of the Company that the effective date of the above-referenced Registration Statement on
Form S-1 be declared effective at 5:00PM Eastern Time on July 12, 2021, or as soon as practicable thereafter.
In
connection with this acceleration request and pursuant to Rule 460 under the Securities Act, please be advised that approximately 1,500
copies of the preliminary prospectus dated June 30, 2021 were distributed to underwriters, dealers, institutions and retail accounts.
The
undersigned advise that the underwriters have complied and will continue to comply with Rule 15c2-8 under the Securities Exchange Act
of 1934, as amended.
Thank
you for your assistance with this matter.
Very truly
yours,
Roth Capital
Partners, LLC
By:
/s/ Aaron M.
Gurewitz
Name:
Aaron M. Gurewitz
Title:
Head of Equity Capital Markets
2021-07-07 - CORRESP - Unicycive Therapeutics, Inc.
CORRESP
1
filename1.htm
Unicycive Therapeutics, Inc.
5150 El Camino Real, Suite A-32
Los Altos, CA 94022
July 7, 2021
VIA EDGAR
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Jeffrey Gabor
Re:
Unicycive Therapeutics, Inc.
Registration Statement on Form S-1
Filed May 21, 2021
File No. 333-256367
Ladies and Gentlemen:
Reference is made to the acceleration request
letter of Unicycive Therapeutics, Inc. (the “Company”) dated July 6, 2021 (the “Acceleration Request”)
requesting, pursuant to Rule 461 under the Securities Act of 1933, as amended, and Rule 12d1-2(b) under the Securities Exchange Act of
1934, as amended, the Securities and Exchange Commission (the “Commission”) to accelerate the effective date of the
above-referenced Registration Statement and declare the Registration Statement, as then amended, effective as of 5:00 p.m., Eastern Daylight
Time, on Wednesday, July 7, 2021, or as soon thereafter as practicable.
The Company hereby notifies the
Commission of its withdrawal of the Acceleration Request for the above-referenced time until such time as the Company may subsequently
request.
UNICYCIVE THERAPEUTICS, INC.
By:
/s/ Shalabh Gupta
Name:
Shalabh Gupta
Title:
Chief Executive Officer
2021-07-06 - CORRESP - Unicycive Therapeutics, Inc.
CORRESP
1
filename1.htm
July 6, 2021
Via EDGAR Submission
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Re: UNICYCIVE THERAPEUTICS, INC. (the “Company”)
Registration Statement on Form S-1
CIK No. 00001766140
SEC Registration No. 333-256367
Ladies and Gentlemen:
Pursuant to Rule 461 under
the Securities Act of 1933, as amended (the “Securities Act”), the undersigned, as underwriters of the proposed offering,
hereby joins the request of the Company that the effective date of the above-referenced Registration Statement on Form S-1 be declared
effective at 5:00PM Eastern Time on July 7, 2021, or as soon as practicable thereafter.
In connection with this acceleration
request and pursuant to Rule 460 under the Securities Act, please be advised that approximately 1,500 copies of the preliminary prospectus
dated June 30, 2021 were distributed to underwriters, dealers, institutions and retail accounts.
The undersigned advise that
the underwriters have complied and will continue to comply with Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Thank you for your assistance
with this matter.
Very truly yours,
Roth Capital
Partners, LLC
By:
/s/ Aaron
M. Gurewitz
Name: Aaron M. Gurewitz
Title: Head of Equity
Capital Markets
2021-07-06 - CORRESP - Unicycive Therapeutics, Inc.
CORRESP
1
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Unicycive Therapeutics, Inc.
5150 El Camino Real, Suite A-32
Los Altos, CA 94022
July 6, 2021
VIA EDGAR
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Jeffrey Gabor
Re:
Unicycive Therapeutics, Inc.
Registration Statement on Form S-1
Filed May 21, 2021
File No. 333-256367
Ladies and Gentlemen:
Pursuant to Rule 461
of the General Rules and Regulations under the Securities Act of 1933, as amended, Unicycive Therapeutics, Inc. (the “Company”)
respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective
at 5:00 p.m., Eastern Daylight Time, on Wednesday. July 7, 2021, or as soon thereafter as possible.
Please notify Jeffrey Fessler
of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (201) 669-0478 as soon as possible as to the time the Registration
Statement has been declared effective pursuant to this acceleration request.
UNICYCIVE THERAPEUTICS, INC.
By:
/s/ Shalabh Gupta
Name:
Shalabh Gupta
Title:
Chief Executive Officer
2021-06-23 - CORRESP - Unicycive Therapeutics, Inc.
CORRESP
1
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Unicycive Therapeutics, Inc.
5150 El Camino Real, Suite A-32
Los Altos, CA 94022
June 23, 2021
VIA EDGAR
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Jeffrey Gabor
Re:
Unicycive Therapeutics, Inc.
Registration Statement on Form S-1
Filed May 21, 2021
File No. 333-256367
Ladies and Gentlemen:
Reference is made to the acceleration request
letter of Unicycive Therapeutics, Inc. (the “Company”) dated June 22, 2021 (the “Acceleration Request”)
requesting, pursuant to Rule 461 under the Securities Act of 1933, as amended, the Securities and Exchange Commission (the “Commission”) to accelerate the effective date of the
above-referenced Registration Statement and declare the Registration Statement, as then amended, effective as of 5:00 p.m., Eastern Daylight
Time, on Thursday, June 24, 2021, or as soon thereafter as practicable.
The Company hereby notifies the
Commission of its withdrawal of the Acceleration Request for the above-referenced time until such time as the Company may subsequently
request.
UNICYCIVE THERAPEUTICS, INC.
By:
/s/ Shalabh Gupta
Name:
Shalabh Gupta
Title:
Chief Executive Officer
2021-06-22 - CORRESP - Unicycive Therapeutics, Inc.
CORRESP
1
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Unicycive Therapeutics, Inc.
5150 El Camino Real, Suite A-32
Los Altos, CA 94022
June 22, 2021
VIA EDGAR
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Jeffrey Gabor
Re:
Unicycive Therapeutics, Inc.
Registration Statement on Form S-1
Filed May 21, 2021
File No. 333-256367
Ladies and Gentlemen:
Pursuant to Rule 461
of the General Rules and Regulations under the Securities Act of 1933, as amended, Unicycive Therapeutics, Inc. (the “Company”)
respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective
at 5:00 p.m., Eastern Daylight Time, on Thursday, June 24, 2021, or as soon thereafter as possible.
Please notify Jeffrey Fessler
of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (201) 669-0478 as soon as possible as to the time the Registration
Statement has been declared effective pursuant to this acceleration request.
UNICYCIVE THERAPEUTICS, INC.
By:
/s/ Shalabh Gupta
Name:
Shalabh Gupta
Title:
Chief Executive Officer
2021-06-14 - CORRESP - Unicycive Therapeutics, Inc.
CORRESP
1
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June 14, 2021
Via EDGAR Submission
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Re: UNICYCIVE THERAPEUTICS, INC. (the “Company”)
Registration Statement on Form S-1
CIK No. 00001766140
SEC Registration No. 333-256367
Ladies and Gentlemen:
Pursuant to Rule 461 under the
Securities Act of 1933, as amended (the “Securities Act”), the undersigned, as underwriters of the proposed offering, hereby
joins the request of the Company that the effective date of the above-referenced Registration Statement on Form S-1 be declared effective
at 5:00PM Eastern Time on June 16, 2021, or as soon as practicable thereafter.
In connection with this acceleration
request and pursuant to Rule 460 under the Securities Act, please be advised that approximately 1,900 copies of the preliminary prospectus
dated June 7, 2021 were distributed to underwriters, dealers, institutions and retail accounts.
The undersigned advise that
the underwriters have complied and will continue to comply with Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Thank you for your assistance
with this matter.
Very truly yours,
Roth Capital Partners, LLC
By:
/s/ Aaron M. Gurewitz
Name: Aaron M. Gurewitz
Title: Head of Equity Capital Markets
2021-06-14 - CORRESP - Unicycive Therapeutics, Inc.
CORRESP
1
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Unicycive Therapeutics, Inc.
5150 El Camino Real, Suite A-32
Los Altos, CA 94022
June 14, 2021
VIA EDGAR
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Celeste Murphy
Re:
Unicycive Therapeutics, Inc.
Registration Statement on Form S-1
Filed May 21, 2021
File No. 333-256367
Ladies and Gentlemen:
Pursuant to Rule 461 of the
General Rules and Regulations under the Securities Act of 1933, as amended, Unicycive Therapeutics, Inc. (the “Company”)
respectfully requests that the effective date of the registration statement referred to above be accelerated so that it will become effective
at 5:00 p.m., Eastern Daylight Time, on Wednesday, June 16, 2021, or as soon thereafter as possible.
Please notify Jeffrey Fessler
of Sheppard, Mullin, Richter & Hampton LLP, counsel to the Company, at (201) 669-0478 as soon as possible as to the time the Registration
Statement has been declared effective pursuant to this acceleration request.
UNICYCIVE THERAPEUTICS, INC.
By:
/s/ Shalabh Gupta
Name:
Shalabh Gupta
Title:
Chief Executive Officer
2021-06-07 - CORRESP - Unicycive Therapeutics, Inc.
CORRESP
1
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Sheppard,
Mullin, Richter & Hampton LLP
30
Rockefeller Plaza
New
York, New York 10112-0015
212.653.8700
main
212.653.8701
fax
www.sheppardmullin.com
June
7, 2021
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, NE
Washington,
D.C. 20549
Re:
Unicycive Therapeutics, Inc.
Registration Statement on Form S-1
Filed May 21, 2021
File No. 333-256367
Ladies
and Gentlemen:
This
letter sets forth the responses of Unicycive Therapeutics, Inc., a Delaware corporation (the “Company”), to the comments
received from the Staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”)
concerning its Registration Statement on Form S-1 (File No. 333-256367) filed with the Commission on May 21, 2021 (the “Registration
Statement”).
References
in the text of the responses herein to captions and page numbers refer to Amendment No. 1 to the Company’s Registration Statement
on Form S-1 (the “Amended Registration Statement”), which is being filed herewith.
Registration
Statement on Form S-1 filed May 21, 2021
Exclusive
Forum, page 86
COMMENT
1:
We note that the choice
of forum provision in your restated certificate to be effective upon the completion of the offering identifies the Court of Chancery
of the State of Delaware as the exclusive forum for certain litigation, including any “derivative action.” We further
note your disclosure on pages 33 and 86 of your prospectus stating that the such provision will not apply to suits brought to enforce
a duty or liability created by the Securities Act or the Exchange Act. Please either (i) amend the provision in your restated certificate
to clearly state that the provision does not apply to federal securities law claims or applies only to state law claims, as applicable,
or (ii) provide reasonable assurance that you will make future investors aware of the provision’s limited applicability, for
example by including such disclosure in your future Exchange Act reports.
RESPONSE:
The Company has amended
its disclosure in the Amended Registration Statement. The Company also hereby confirms that it will make future investors aware of
the provision’s limited applicability, including, but not limited to, in the Company’s future Exchange Act reports.
If
you have any questions relating to any of the foregoing, please contact Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton
LLP at (212) 653-8700.
Very truly yours,
/s/
Jeffrey Fessler
Sheppard, Mullin, Richter
& Hampton LLP
2021-06-03 - UPLOAD - Unicycive Therapeutics, Inc.
United States securities and exchange commission logo
June 3, 2021
Shalabh Gupta, M.D.
Chief Executive Officer, President and Chairman
Unicycive Therapeutics, Inc.
5150 El Camino Real, Suite A-32
Los Altos, CA 94022
Re:Unicycive Therapeutics, Inc.
Registration Statement on Form S-1
Filed May 21, 2021
File No. 333-256367
Dear Dr. Gupta:
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-1 filed May 21, 2021
Exclusive Forum, page 86
1.We note that the choice of forum provision in your restated certificate to be effective upon
the completion of the offering identifies the Court of Chancery of the State of Delaware as
the exclusive forum for certain litigation, including any "derivative action." We further
note your disclosure on pages 33 and 86 of your prospectus stating that the such provision
will not apply to suits brought to enforce a duty or liability created by the Securities Act or
the Exchange Act. Please either (i) amend the provision in your restated certificate to
clearly state that the provision does not apply to federal securities law claims or applies
only to state law claims, as applicable, or (ii) provide reasonable assurance that you will
make future investors aware of the provision’s limited applicability, for example by
including such disclosure in your future Exchange Act reports.
FirstName LastNameShalabh Gupta, M.D.
Comapany NameUnicycive Therapeutics, Inc.
June 3, 2021 Page 2
FirstName LastName
Shalabh Gupta, M.D.
Unicycive Therapeutics, Inc.
June 3, 2021
Page 2
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
You may contact Ibolya Ignat at 202-551-3636 or Brian Cascio at 202-551-3676 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jeffrey Gabor at 202-551-2544 or Celeste Murphy at 202-551-3257 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey Fessler, Esq.
2021-05-21 - CORRESP - Unicycive Therapeutics, Inc.
CORRESP
1
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Sheppard, Mullin, Richter & Hampton LLP
30 Rockefeller Plaza
New York, New York 10112-0015
212.653.8700 main
212.653.8701 fax
www.sheppardmullin.com
May 21, 2021
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, D.C. 20549
Re:
Unicycive Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted on April 29, 2021
CIK No. 0001766140
Ladies and Gentlemen:
This letter sets forth the responses
of Unicycive Therapeutics, Inc., a Delaware corporation (the “Company”), to the comments received from the Staff (the
“Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) concerning Amendment
No. 3 to its Draft Registration Statement on Form S-1 (CIK No. 0001766140) submitted to the Commission on April 29, 2021 (the “Registration
Statement”).
References in the text of the
responses herein to captions and page numbers refer to the Company’s Registration Statement on Form S-1 (the “Registration
Statement”), which is being filed herewith.
Amendment No. 3 to Draft Registration Statement on Form S-1 submitted
February 18, 2021
BUSINESS
Recent Developments, page 48
COMMENT 1:
Please file your Ascent Master Services Agreement
as an exhibit or provide your analysis
identifying how you determined that the agreement
did not need to be filed as an exhibit.
Please refer to Item 601(b)(10) of Regulation S-K.
RESPONSE:
The
Company has filed the Ascent Master Services Agreement as Exhibit 10.10 to the Registration Statement.
If you have any questions relating to any of
the foregoing, please contact Jeffrey Fessler of Sheppard, Mullin, Richter & Hampton LLP at (212) 653-8700.
Very truly yours,
/s/ Jeffrey Fessler
Sheppard, Mullin, Richter & Hampton LLP
2021-05-10 - UPLOAD - Unicycive Therapeutics, Inc.
United States securities and exchange commission logo
May 10, 2021
Shalabh Gupta, M.D.
Chief Executive Officer, President and Chairman
Unicycive Therapeutics, Inc.
5150 El Camino Real, Suite A-32
Los Altos, CA 94022
Re:Unicycive Therapeutics, Inc.
Amendment No. 3 to Draft Registration Statement on Form S-1
Submitted April 29, 2021
CIK No. 0001766140
Dear Dr. Gupta:
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. 3 to Draft Registration Statement on Form S-1
BUSINESS
Recent Developments, page 48
1.Please file your Ascent Master Services Agreement as an exhibit or provide your analysis
identifying how you determined that the agreement did not need to be filed as an exhibit.
Please refer to Item 601(b)(10) of Regulation S-K.
FirstName LastNameShalabh Gupta, M.D.
Comapany NameUnicycive Therapeutics, Inc.
May 10, 2021 Page 2
FirstName LastName
Shalabh Gupta, M.D.
Unicycive Therapeutics, Inc.
May 10, 2021
Page 2
You may contact Ibolya Ignat at 202-551-3636 or Brian Cascio at 202-551-3676 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jeffrey Gabor at 202-551-2544 or Celeste Murphy at 202-551-3257 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey Fessler, Esq.
2021-03-17 - UPLOAD - Unicycive Therapeutics, Inc.
United States securities and exchange commission logo
March 17, 2021
Shalabh Gupta, M.D.
Chief Executive Officer, President and Chairman
Unicycive Therapeutics, Inc.
5150 El Camino Real, Suite A-32
Los Altos, CA 94022
Re:Unicycive Therapeutics, Inc.
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted February 18, 2021
CIK No. 0001766140
Dear Dr. Gupta:
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 on Form S-1 submitted February 18, 2021
Background on Renazorb, page 52
1.We note your statement here and on page 53 that "Renazorb was minimally absorbed to
the systemic circulation and was safe...." Please revise these and all similar statements
throughout your prospectus that state or imply that your product candidates are safe or
effective as these determinations are solely within the authority of the FDA and
comparable regulatory bodies.
General
2.We note your response to prior comment 4 and reissue. The pipeline table on page 49 and
on your website indicates that Renazorb has completed Phase 3 clinical trials. However,
FirstName LastNameShalabh Gupta, M.D.
Comapany NameUnicycive Therapeutics, Inc.
March 17, 2021 Page 2
FirstName LastName
Shalabh Gupta, M.D.
Unicycive Therapeutics, Inc.
March 17, 2021
Page 2
we note your disclosure on page 1 that "Spectrum conducted a Phase 1 clinical trial with
Renazorb in 2012 prior to the grant of [your] license in 2018." To the extent that you
have completed Phase 2 and 3 clinical trials, please include disclosure that complies with
prior comment 3. Otherwise, revise the pipeline table on page 49 and on your website to
illustrate the product candidate's current status.
You may contact Ibolya Ignat at 202-551-3636 or Brian Cascio at 202-551-3676 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jeffrey Gabor at 202-551-2544 or Celeste Murphy at 202-551-3257 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey Fessler, Esq.
2020-11-10 - UPLOAD - Unicycive Therapeutics, Inc.
United States securities and exchange commission logo
November 10, 2020
Shalabh Gupta, M.D.
Chief Executive Officer, President and Chairman
Unicycive Therapeutics, Inc.
5150 El Camino Real, Suite A-32
Los Altos, CA 94022
Re:Unicycive Therapeutics, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted November 2, 2020
CIK No. 0001766140
Dear Dr. Gupta:
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 November 2, 2020
PROSPECTUS SUMMARY
Overview, page 1
1.We note your response to prior comment 1 and that UNI 494 was initially developed
by Sphaera Pharmaceuticals. Please revise the business section to clearly disclose the
discovery/preclinical work conducted by Sphaera Pharmaceuticals.
Business
Background on Renazorb, page 52
2.We note your response to prior comment 2 and your revised disclosure here and
throughout the registration statement that your candidate has "the potential to be
FirstName LastNameShalabh Gupta, M.D.
Comapany NameUnicycive Therapeutics, Inc.
November 10, 2020 Page 2
FirstName LastName
Shalabh Gupta, M.D.
Unicycive Therapeutics, Inc.
November 10, 2020
Page 2
effective." Please revise the prospectus to remove any statements that suggest the efficacy
of your candidate, as these determinations are the exclusive authority of the FDA or other
regulators.
Clinical Trial Experience, page 53
3.We note your response to prior comment 8 and reissue. For the clinical trial discussed in
this section, please disclose the phase; the date(s) of the trial and the location; duration of
treatment and dosage information (both amount and frequency); the specific endpoints
established by the trial protocol; and actual results observed, including whether statistical
significance was demonstrated and the p-values supporting statistical significance.
General
4.We note your response to prior comment 14. The pipeline table on page 49 and on your
website indicates that Renazorb has completed Phase 3 clinical trials. However, we note
your disclosure on page 1 that "Spectrum conducted a Phase 1 clinical trial with Renazorb
in 2012 prior to the grant of [your] license in 2018." To the extent that you have
completed Phase 2 and 3 clinical trials, please include disclosure that complies with
comment 3 above. Otherwise, revise the pipeline table on page 49 and on your website to
illustrate the product candidate's current status.
You may contact Ibolya Ignat at 202-551-3636 or Brian Cascio at 202-551-3676 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jeffrey Gabor at 202-551-2544 or Celeste Murphy at 202-551-3257 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey Fessler, Esq.
2020-10-09 - UPLOAD - Unicycive Therapeutics, Inc.
United States securities and exchange commission logo
October 9, 2020
Shalabh Gupta, M.D.
Chief Executive Officer, President and Chairman
Unicycive Therapeutics, Inc.
5150 El Camino Real, Suite A-32
Los Altos, CA 94022
Re:Unicycive Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted September 15, 2020
CIK No. 0001766140
Dear Dr. Gupta:
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 submitted September 15, 2020
PROSPECTUS SUMMARY
Overview, page 1
1.Please revise the Summary to explain in greater detail the development history and
clinical status of UNI 218 and UNI 494. Without limitation, please discuss who
developed these products and conducted the preclinical and clinical trials and discuss what
clinical trial work, if any, has been conducted or will need to be conducted. In your
revised disclosure, please also include the dates of the prior preclinical and clinical trials.
2.We note your use of the term "significant unmet medical need" here and elsewhere in the
document. Such a term might imply that your products are eligible for fast track
FirstName LastNameShalabh Gupta, M.D.
Comapany NameUnicycive Therapeutics, Inc.
October 9, 2020 Page 2
FirstName LastName
Shalabh Gupta, M.D.
Unicycive Therapeutics, Inc.
October 9, 2020
Page 2
designation or priority review granted by the FDA for products that treat certain serious
unmet medical needs. Please remove your use of this term throughout or otherwise please
explain why you believe use of this term is appropriate.
Implications of Being an Emerging Growth Company, page 2
3.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.
RISK FACTORS
We may be adversely affected by the ongoing coronavirus pandemic, page 14
4.Please expand this risk factor to specifically describe the impact of the COVID-19
pandemic on your operations.
USE OF PROCEEDS, page 35
5.Please state the approximate amount of proceeds you intend to use for each purpose
listed. See Item 504 of Regulation S-K.
BUSINESS
Background on Renazorb, page 52
6.We note your belief that Renazorb is "potent and selective." Given the stage of your
product development, it appears premature to describe your product candidate as potent,
which implies they are effective. Please revise or advise why this disclosure is
appropriate.
7.We note your disclosure regarding the completed clinical trial where it "was concluded
that Renazorb was efficacious...." As efficacy determinations are the province of the U.S.
Food and Drug Administration and other comparable regulatory agencies, please remove
this statement here and elsewhere in your prospectus and replace them with quantified
disclosure that supports each assessment.
Clinical Trial Experience, page 53
8.The trial discussed in this section provide results without providing proper context for
such results. For the clinical trial discussed in this section, please disclose the phase; the
date(s) of the trial and the location; duration of treatment and dosage information (both
amount and frequency); the specific endpoints established by the trial protocol; and actual
results observed, including whether statistical significance was demonstrated and the p-
values supporting statistical significance.
FirstName LastNameShalabh Gupta, M.D.
Comapany NameUnicycive Therapeutics, Inc.
October 9, 2020 Page 3
FirstName LastName
Shalabh Gupta, M.D.
Unicycive Therapeutics, Inc.
October 9, 2020
Page 3
Market Potential, page 54
9.We note that the information regarding the total hyperphosphatemia market is based on a
study conducted on your behalf by Syneos Health. Please tell us whether you
commissioned this study for use in the registration statement, and, if so, analyze whether
you are required to file a consent pursuant to Rule 436 of the Securities Act.
Clinical trials for UNI 494 in AKI, page 59
10.Please revise to clearly disclose the current development phase for UNI 494. To the
extent that preclinical trials have been conducted, please disclose the date(s) of the trials
and the location; duration of treatment and dosage information (both amount and
frequency); the specific endpoints established by the trial protocol; and actual results
observed.
Employees and Labor Relations, page 70
11.We note your disclosure that you have one full time employee. We also note that your
website includes profiles of eleven individuals. Please revise or advise.
EXECUTIVE AND DIRECTOR COMPENSATION
Employment Agreements, page 75
12.Please file the employment agreement with Shalabh Gupta as an exhibit to the registration
statement as required by Item 601(b)(10) of Regulation S-K.
DESCRIPTION OF CAPITAL STOCK
Exclusive Forum, page 82
13.We note that your forum selection provision identifies the State of Delaware as the
exclusive forum for certain litigation, including any “derivative action.” Consistent with
the risk factor disclosure on page 32, please disclose whether this provision applies to
actions arising under the Securities Act or Exchange Act. Additionally, because you have
identified the federal courts as the exclusive forum for Securities Act claims, please also
revise your prospectus to state that there is uncertainty as to whether a court would
enforce such provision and that investors cannot waive compliance with the federal
securities laws and the rules and regulations thereunder.
General
14.We note that the product development pipeline chart on your website appears inconsistent
with information disclosed in your document as your website indicates that the FDA has
approved a request to use a 505(b)(2) pathway for Renazorb. Please revise or advise.
FirstName LastNameShalabh Gupta, M.D.
Comapany NameUnicycive Therapeutics, Inc.
October 9, 2020 Page 4
FirstName LastName
Shalabh Gupta, M.D.
Unicycive Therapeutics, Inc.
October 9, 2020
Page 4
You may contact Ibolya Ignat at 202-551-3636 or Brian Cascio at 202-551-3676 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jeffrey Gabor at 202-551-2544 or Celeste Murphy at 202-551-3257 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jeffrey Fessler, Esq.
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