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Longeveron Inc.
Response Received
2 company response(s)
Medium - date proximity
↓
↓
Longeveron Inc.
Response Received
1 company response(s)
High - file number match
↓
Longeveron Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-08-08
Longeveron Inc.
Summary
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Company responded
2024-08-09
Longeveron Inc.
Summary
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Longeveron Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-07-03
Longeveron Inc.
Summary
Generating summary...
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Company responded
2024-07-05
Longeveron Inc.
Summary
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Longeveron Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-05-06
Longeveron Inc.
Summary
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Company responded
2024-05-17
Longeveron Inc.
Summary
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Longeveron Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2024-02-09
Longeveron Inc.
Summary
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Company responded
2024-03-01
Longeveron Inc.
References: February 9, 2024
Summary
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Company responded
2024-04-16
Longeveron Inc.
Summary
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Longeveron Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2024-03-27
Longeveron Inc.
Summary
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Company responded
2024-04-08
Longeveron Inc.
Summary
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Company responded
2024-04-08
Longeveron Inc.
Summary
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Longeveron Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-11-16
Longeveron Inc.
Summary
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Company responded
2023-11-17
Longeveron Inc.
Summary
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Longeveron Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2023-07-11
Longeveron Inc.
Summary
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Company responded
2023-07-28
Longeveron Inc.
References: July 11,
2023
Summary
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2023-08-11
Longeveron Inc.
Summary
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Longeveron Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-04-12
Longeveron Inc.
Summary
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Company responded
2022-04-12
Longeveron Inc.
Summary
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Longeveron Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-12-17
Longeveron Inc.
Summary
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Company responded
2021-12-20
Longeveron Inc.
Summary
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Longeveron Inc.
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2021-02-01
Longeveron Inc.
Summary
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Company responded
2021-02-03
Longeveron Inc.
References: February 1, 2021
Summary
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Company responded
2021-02-09
Longeveron Inc.
Summary
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Company responded
2021-02-09
Longeveron Inc.
Summary
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Company responded
2021-02-10
Longeveron Inc.
References: February 9, 2021
Summary
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Longeveron Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-02-09
Longeveron Inc.
Summary
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Longeveron Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2021-01-14
Longeveron Inc.
Summary
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Company responded
2021-01-19
Longeveron Inc.
References: January 14, 2021
Summary
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Longeveron Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2020-12-10
Longeveron Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-08 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2025-08-08 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2025-07-25 | SEC Comment Letter | Longeveron Inc. | DE | 377-08240 | Read Filing View |
| 2025-04-02 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2025-03-31 | SEC Comment Letter | Longeveron Inc. | DE | 333-286217 | Read Filing View |
| 2024-08-09 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2024-08-08 | SEC Comment Letter | Longeveron Inc. | DE | 333-281299 | Read Filing View |
| 2024-07-05 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2024-07-03 | SEC Comment Letter | Longeveron Inc. | DE | 333-280577 | Read Filing View |
| 2024-05-17 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2024-05-06 | SEC Comment Letter | Longeveron Inc. | DE | 333-278995 | Read Filing View |
| 2024-04-16 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2024-04-08 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2024-04-08 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2024-03-27 | SEC Comment Letter | Longeveron Inc. | DE | 333-278073 | Read Filing View |
| 2024-03-01 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2024-02-09 | SEC Comment Letter | Longeveron Inc. | DE | 333-276745 | Read Filing View |
| 2023-11-17 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2023-11-16 | SEC Comment Letter | Longeveron Inc. | DE | N/A | Read Filing View |
| 2023-08-11 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2023-07-28 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2023-07-11 | SEC Comment Letter | Longeveron Inc. | DE | N/A | Read Filing View |
| 2022-04-12 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2022-04-12 | SEC Comment Letter | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-12-20 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-12-17 | SEC Comment Letter | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-02-10 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-02-09 | SEC Comment Letter | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-02-09 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-02-09 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-02-03 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-02-01 | SEC Comment Letter | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-01-19 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-01-14 | SEC Comment Letter | Longeveron Inc. | DE | N/A | Read Filing View |
| 2020-12-10 | SEC Comment Letter | Longeveron Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-25 | SEC Comment Letter | Longeveron Inc. | DE | 377-08240 | Read Filing View |
| 2025-03-31 | SEC Comment Letter | Longeveron Inc. | DE | 333-286217 | Read Filing View |
| 2024-08-08 | SEC Comment Letter | Longeveron Inc. | DE | 333-281299 | Read Filing View |
| 2024-07-03 | SEC Comment Letter | Longeveron Inc. | DE | 333-280577 | Read Filing View |
| 2024-05-06 | SEC Comment Letter | Longeveron Inc. | DE | 333-278995 | Read Filing View |
| 2024-03-27 | SEC Comment Letter | Longeveron Inc. | DE | 333-278073 | Read Filing View |
| 2024-02-09 | SEC Comment Letter | Longeveron Inc. | DE | 333-276745 | Read Filing View |
| 2023-11-16 | SEC Comment Letter | Longeveron Inc. | DE | N/A | Read Filing View |
| 2023-07-11 | SEC Comment Letter | Longeveron Inc. | DE | N/A | Read Filing View |
| 2022-04-12 | SEC Comment Letter | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-12-17 | SEC Comment Letter | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-02-09 | SEC Comment Letter | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-02-01 | SEC Comment Letter | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-01-14 | SEC Comment Letter | Longeveron Inc. | DE | N/A | Read Filing View |
| 2020-12-10 | SEC Comment Letter | Longeveron Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-08 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2025-08-08 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2025-04-02 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2024-08-09 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2024-07-05 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2024-05-17 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2024-04-16 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2024-04-08 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2024-04-08 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2024-03-01 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2023-11-17 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2023-08-11 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2023-07-28 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2022-04-12 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-12-20 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-02-10 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-02-09 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-02-09 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-02-03 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
| 2021-01-19 | Company Response | Longeveron Inc. | DE | N/A | Read Filing View |
2025-08-08 - CORRESP - Longeveron Inc.
CORRESP
1
filename1.htm
August 8, 2025
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Washington, DC 20549
Re:
Longeveron Inc.
Registration Statement on Form S-1 (File No. 333-289210), as amended – 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 (File No. 333-289210), as amended (the " Registration Statement "), hereby concurs in the request
by Longeveron Inc. that the effective date of the above-referenced registration statement be accelerated to 1:00 P.M. (Eastern Time), or
as soon as practicable thereafter, on August 8, 2025, pursuant to Rule 461 under the Securities Act of 1933, as amended (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
2025-08-08 - CORRESP - Longeveron Inc.
CORRESP 1 filename1.htm LONGEVERON INC. 1951 NW 7 th Avenue, Suite 520 Miami, Florida 33136 August 8, 2025 Via EDGAR Transmission United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Joshua Gorsky Re: Longeveron Inc. Registration Statement on Form S-1 File No. 333-289210 Request for Acceleration of Effectiveness Dear Mr. Gorsky: In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, Longeveron Inc. (the "Registrant") hereby respectfully requests acceleration of the effective date of the above-referenced Registration Statement on Form S-1 (File No. 333-289210), as amended, so that it may become effective on August 8, 2025, at 1:00 p.m., Eastern Time, or as soon thereafter as practicable. The Registrant hereby authorizes Jennifer Minter, Esq. or Adam G. Wicks, Esq., to orally modify or withdraw this request for acceleration. Please contact Jennifer Minter of Buchanan Ingersoll & Rooney PC, counsel to the Company, at (412) 562-8444, or in her absence, Adam Wicks at (412) 562-8331, to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter. Sincerely yours, Longeveron Inc. By: /s/ Wa'el Hashad Wa'el Hashad Chief Executive Officer cc: Lisa A. Locklear, CFO Jennifer Minter Adam Wicks
2025-07-25 - UPLOAD - Longeveron Inc. File: 377-08240
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 25, 2025 Wa el Hashad Chief Executive Officer Longeveron Inc. 1951 NW 7th Avenue, Suite 520 Miami, FL 33136 Re: Longeveron Inc. Draft Registration Statement on Form S-1 Submitted July 21, 2025 CIK No. 0001721484 Dear Wa el Hashad: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement at least two business days prior to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Joshua Gorsky at 202-551-7836 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Jennifer Minter, Esq. </TEXT> </DOCUMENT>
2025-04-02 - CORRESP - Longeveron Inc.
CORRESP 1 filename1.htm L ONGEVERON INC. 1951 NW 7 th Avenue, Suite 520 Miami, Florida 33136 April 2, 2025 Via EDGAR Transmission United States Securities and Exchange Commission Division of Corporation Finance, Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Jason Drory Re: Longeveron Inc. Registration Statement on Form S-3 Filed March 28, 2025 File No. 333-286217 Request for Acceleration of Effectiveness Dear Mr. Drory: In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, Longeveron Inc. (the "Registrant") hereby respectfully requests acceleration of the effective date of the above-referenced Registration Statement on Form S-3 (File No. 333-286217), so that it may become effective on Friday, April 4, 2025, at 4:30 p.m., Eastern Time, or as soon thereafter as practicable. The Registrant hereby authorizes Jennifer Minter, Esq., to orally modify or withdraw this request for acceleration. Please contact Jennifer Minter of Buchanan Ingersoll & Rooney PC, counsel to the Registrant, at (412) 562-8444, or in her absence, Stan Marciniak at (412) 562-1537, to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter. Sincerely yours, Longeveron Inc. By: /s/ Wa'el Hashad Wa'el Hashad Chief Executive Officer cc: Lisa Locklear, CFO Jennifer Minter, Esq. Stan Marciniak, Esq.
2025-03-31 - UPLOAD - Longeveron Inc. File: 333-286217
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 31, 2025 Wa el Hashad Chief Executive Officer Longeveron Inc. 1951 NW 7th Avenue, Suite 520 Miami, FL 33136 Re: Longeveron Inc. Registration Statement on Form S-3 Filed March 28, 2025 File No. 333-286217 Dear Wa el Hashad: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Jason Drory at 202-551-8342 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Jennifer Minter </TEXT> </DOCUMENT>
2024-08-09 - CORRESP - Longeveron Inc.
CORRESP
1
filename1.htm
LONGEVERON INC.
1951 NW 7th Avenue, Suite 520
Miami, Florida 33136
August 9, 2024
Via EDGAR Transmission
United States Securities and Exchange Commission
Division of Corporation Finance, Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Tim Buchmiller
Re:
Longeveron Inc.
Registration Statement on Form S-1
Filed August 6, 2024
File No. 333-281299
Request for Acceleration of Effectiveness
Dear Mr. Buchmiller:
In accordance with Rule 461 of Regulation C of
the General Rules and Regulations under the Securities Act of 1933, as amended, Longeveron Inc. (the “Registrant”) hereby
respectfully requests acceleration of the effective date of the above-referenced Registration Statement on Form S-1 (File No. 333-281299),
so that it may become effective on August 12, 2024, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable. The Registrant hereby
authorizes Jennifer Minter, Esq., to orally modify or withdraw this request for acceleration.
Please contact Jennifer Minter of Buchanan Ingersoll
& Rooney PC, counsel to the Company, at (412) 562-8444, or in her absence, Adam Wicks at (412) 562-8331, to provide notice of effectiveness,
or if you have any other questions or concerns regarding this matter.
Sincerely yours,
Longeveron Inc.
By:
/s/ Wa’el Hashad
Wa’el Hashad
Chief Executive Officer
cc:
Jennifer Minter
Adam Wicks
2024-08-08 - UPLOAD - Longeveron Inc. File: 333-281299
August 8, 2024
Wa’el Hashad
Chief Executive Officer
Longeveron Inc.
1951 NW 7th Avenue, Suite 520
Miami, Florida 33136
Re:Longeveron Inc.
Registration Statement on Form S-1
Filed August 6, 2024
File No. 333-281299
Dear Wa’el Hashad:
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:Jennifer Minter, Esq.
2024-07-05 - CORRESP - Longeveron Inc.
CORRESP
1
filename1.htm
LONGEVERON
INC.
1951
NW 7th Avenue, Suite 520
Miami,
Florida 33136
July
5, 2024
Via
EDGAR Transmission
United
States Securities and Exchange Commission
Division
of Corporation Finance, Office of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attention: Jimmy
McNamara
Re:
Longeveron
Inc.
Registration
Statement on Form S-1
Filed
June 28, 2024
File
No. 333-280577
Request
for Acceleration of Effectiveness
Dear
Mr. McNamara:
In
accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, Longeveron
Inc. (the “Registrant”) hereby respectfully requests acceleration of the effective date of the above-referenced Registration
Statement on Form S-1 (File No. 333-280577), so that it may become effective on July 9, 2024, at 5:00 p.m., Eastern Time, or as soon
thereafter as practicable. The Registrant hereby authorizes Jennifer Minter, Esq., to orally modify or withdraw this request for acceleration.
Please
contact Jennifer Minter of Buchanan Ingersoll & Rooney PC, counsel to the Company, at (412) 562-8444, or in her absence, Adam Wicks
at (412) 562-8331, to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter.
Sincerely
yours,
Longeveron
Inc.
By:
/s/
Wa’el Hashad
Wa’el
Hashad
Chief
Executive Officer
cc:
Jennifer
Minter
Adam Wicks
2024-07-03 - UPLOAD - Longeveron Inc. File: 333-280577
July 3, 2024
Wa’el Hashad
Chief Executive Officer
Longeveron Inc.
1951 NW 7th Avenue, Suite 520
Miami, Florida 33136
Re:Longeveron Inc.
Registration Statement on Form S-1
Filed June 28, 2024
File No. 333-280577
Dear Wa’el Hashad:
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 Jimmy McNamara at 202-551-7349 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Jennifer Minter
2024-05-17 - CORRESP - Longeveron Inc.
CORRESP
1
filename1.htm
LONGEVERON INC.
1951 NW 7th Avenue, Suite 520
Miami, Florida 33136
May 17, 2024
Via EDGAR Transmission
United States Securities and Exchange Commission
Division of Corporation Finance, Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention: Tyler
Howes
Re:
Longeveron Inc.
Registration Statement on Form S-1
Filed April 30, 2024
File No. 333-278995
Request for Acceleration of Effectiveness
Dear Mr. Howes:
In accordance with Rule 461 of Regulation C of
the General Rules and Regulations under the Securities Act of 1933, as amended, Longeveron Inc. (the “Registrant”) hereby
respectfully requests acceleration of the effective date of the above-referenced Registration Statement on Form S-1 (File No. 333-278995),
so that it may become effective on May 21, 2024, at 5:00 p.m., Eastern Time, or as soon thereafter as practicable. The Registrant hereby
authorizes Jennifer Minter, Esq., to orally modify or withdraw this request for acceleration.
Please contact Jennifer Minter of Buchanan Ingersoll
& Rooney PC, counsel to the Registrant, at (412) 562-8444, or in her absence, Adam Wicks at (412) 562-8331, to provide notice of effectiveness,
or if you have any other questions or concerns regarding this matter.
Sincerely yours,
Longeveron Inc.
By:
/s/ Wa’el Hashad
Wa’el Hashad
Chief Executive Officer
cc:
Jennifer Minter
Adam Wicks
2024-05-06 - UPLOAD - Longeveron Inc. File: 333-278995
United States securities and exchange commission logo
May 6, 2024
Lisa Locklear
Chief Financial Officer
Longeveron Inc.
1951 NW 7th Avenue, Suite 520
Miami, FL 33136
Re:Longeveron Inc.
Registration Statement on Form S-1
Filed April 30, 2024
File No. 333-278995
Dear Lisa Locklear:
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: Jennifer Minter, Esq.
2024-04-16 - CORRESP - Longeveron Inc.
CORRESP
1
filename1.htm
LONGEVERON INC.
1951 NW 7th Avenue, Suite 520
Miami, Florida 33136
April 16, 2024
Via EDGAR Transmission
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Tamika Sheppard
Re:
Longeveron Inc.
Registration Statement on Form S-1
Filed January 29, 2024
File No. 333-276745
Request for Acceleration of Effectiveness
Dear Ms. Sheppard:
In accordance with Rule 461 of Regulation C of
the General Rules and Regulations under the Securities Act of 1933, as amended, Longeveron Inc. (the “Registrant”) hereby
respectfully requests acceleration of the effective date of the above-referenced Registration Statement on Form S-1 (File No. 333-276745),
so that it may become effective on April 17, 2024, at 4:15 p.m., Eastern Time, or as soon thereafter as practicable. The Registrant hereby
authorizes Jennifer Minter, Esq., to orally modify or withdraw this request for acceleration.
Please contact Jennifer Minter of Buchanan Ingersoll
& Rooney PC, counsel to the Company, at (412) 562-8444, or in her absence, Adam Wicks at (412) 562-8331, to provide notice of effectiveness,
or if you have any other questions or concerns regarding this matter.
Sincerely yours,
Longeveron Inc.
By:
/s/ Wa’el Hashad
Wa’el Hashad
Chief Executive Officer
cc:
Jennifer Minter
Adam Wicks
2024-04-08 - CORRESP - Longeveron Inc.
CORRESP
1
filename1.htm
April 8, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporate Finance
Washington, DC 20549
Re:
Longeveron Inc.
Registration Statement on Form S-1 (Registration
No. 333-278073), as amended - 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 (333-278073), as amended (the “Registration Statement”), hereby concurs in the request by Longeveron
Inc. that the effective date of the above-referenced registration statement be accelerated to 2:00 P.M. (Eastern Time), or as soon as
practicable thereafter, on April 8, 2024, pursuant to Rule 461 under the Securities Act. Wainwright affirms that it is aware of its obligations
under the Securities Act as they pertain to the best efforts offering pursuant to the Registration Statement.
Very truly yours,
H.C. WAINWRIGHT & CO., LLC
By:
/s/ Edward D. Silvera
Name:
Edward D. Silvera
Title:
Chief Operating Officer
2024-04-08 - CORRESP - Longeveron Inc.
CORRESP
1
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LONGEVERON INC.
1951 NW 7th Avenue, Suite 520
Miami, Florida 33136
April 8, 2024
Via EDGAR Transmission
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Tamika Sheppard
Re:
Longeveron Inc.
Registration Statement on Form S-1
File No. 333-278073
Request for Acceleration of Effectiveness
Dear Ms. Sheppard:
In accordance with Rule 461 of Regulation C
of the General Rules and Regulations under the Securities Act of 1933, as amended, Longeveron Inc. (the “Registrant”)
hereby respectfully requests acceleration of the effective date of the above-referenced Registration Statement on Form S-1 (File No.
333-278073), as amended, so that it may become effective on Monday, April 8, 2024, at 2:00 p.m., Eastern Time, or as soon thereafter as
practicable. The Registrant hereby authorizes Jennifer Minter, Esq., to orally modify or withdraw this request for acceleration.
Please contact Jennifer Minter of Buchanan Ingersoll
& Rooney PC, counsel to the Company, at (412) 562-8444, or in her absence, Adam Wicks at (412) 562-8331, to provide notice of effectiveness,
or if you have any other questions or concerns regarding this matter.
Sincerely yours,
Longeveron Inc.
By:
/s/ Wa’el Hashad
Wa’el Hashad
Chief Executive Officer
cc:
Jennifer Minter
Adam Wicks
2024-03-27 - UPLOAD - Longeveron Inc. File: 333-278073
United States securities and exchange commission logo
March 27, 2024
Lisa Locklear
Chief Financial Officer
Longeveron Inc.
1951 NW 7th Avenue, Suite 520
Miami, Florida 33136
Re:Longeveron Inc.
Registration Statement on Form S-1
Filed on March 19, 2024
File No. 333-278073
Dear Lisa Locklear:
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 Tamika Sheppard at 202-551-8346 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Adam Wicks
2024-03-01 - CORRESP - Longeveron Inc.
CORRESP
1
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Longeveron Inc.
1951 NW 7th Avenue, Suite 520
Miami, Florida 33136
February 29, 2024
Division of Corporation Finance
Office of Life Sciences
U.S. Securities and Exchange Commission
100 F Street N.E.
Washington, D.C. 20549
Attn:
Tamika Sheppard
Alan Campbell
Re:
Longeveron Inc.
Registration Statement on Form S-1 Filed
January 29, 2024
File No. 333-276745
Dear Ms. Sheppard and Mr. Campbell:
We are writing in connection
with the above-captioned matter regarding the Registration Statement on Form S-1, File No. 333-276745, of Longeveron
Inc. (the “Company”) filed with the Securities and Exchange Commission (the “Commission”) on January 29, 2024
(the “Form S-1”). We hereby provide the following response to the Staff’s comment letter dated February 9, 2024.
Incorporation of Certain Information by Reference,
page 71
1. It appears that you are attempting to rely on Instruction VII to Form S-1 to incorporate by reference
previously filed and future filings of Exchange Act reports. Because you have not yet filed your Form 10-K for your most recently completed
fiscal year, December 31, 2023, it appears that you have not satisfied the requirements of paragraph C of that instruction. Please either
file your Form 10-K, including the information required by Part III, or revise your filing to include all disclosures required by Form
S-1.
Response: The Company has now filed its Form
10-K Annual Report for the fiscal year ended December 31, 2023, which includes the information required by Part III of Form S-1. The Company
will shortly file an amendment to its Form S-1 to conform to the updated information contained in its Form 10-K Annual Report.
We hope that the foregoing is responsive to the Staff’s
comments. Please do not hesitate to contact our counsel, Jennifer Minter, Esq., at (412) 562-8444 if you have any questions regarding
this matter.
Sincerely,
/s/ Wa’el Hashad
Wa’el Hashad
Chief Executive Officer
cc: Jennifer M. Minter, Esq.
2024-02-09 - UPLOAD - Longeveron Inc. File: 333-276745
United States securities and exchange commission logo
February 9, 2024
Wa’el Hashad
Chief Executive Officer
Longeveron Inc.
1951 NW 7th Avenue, Suite 520
Miami, Florida 33136
Re:Longeveron Inc.
Registration Statement on Form S-1
Filed January 29, 2024
File No. 333-276745
Dear Wa’el Hashad:
We have conducted a limited review of your 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 letter, we may have additional comments.
Registration Statement on Form S-1, filed January 29, 2024
Incorporation of Certain Information by Reference, page 71
1.It appears that you are attempting to rely on Instruction VII to Form S-1 to incorporate by
reference previously filed and future filings of Exchange Act reports. Because you have
not yet filed your Form 10-K for your most recently completed fiscal year, December 31,
2023, it appears that you have not satisfied the requirements of paragraph C of
that instruction. Please either file your Form 10-K, including the information required by
Part III, or revise your filing to include all disclosures required by Form S-1.
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.
FirstName LastNameWa’el Hashad
Comapany NameLongeveron Inc.
February 9, 2024 Page 2
FirstName LastName
Wa’el Hashad
Longeveron Inc.
February 9, 2024
Page 2
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Tamika Sheppard at 202-551-8346 or Alan Campbell at 202-551-4224
with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jennifer Minter
2023-11-17 - CORRESP - Longeveron Inc.
CORRESP
1
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LONGEVERON INC.
1951 NW 7th Avenue, Suite 520
Miami, Florida 33136
November 17, 2023
Via EDGAR Transmission
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Joshua Gorsky
Re:
Longeveron Inc.
Registration Statement on Form S-1
Filed November 15, 2023
File No. 333-275578
Request for Acceleration of Effectiveness
Dear Mr. Gorsky:
In accordance with Rule 461 of Regulation C
of the General Rules and Regulations under the Securities Act of 1933, as amended, Longeveron Inc. (the “Registrant”) hereby
respectfully requests acceleration of the effective date of the above-referenced Registration Statement on Form S-1 (File No. 333-275578),
so that it may become effective on Tuesday, November 21, 2023, at 4:15 p.m., Eastern Time, or as soon thereafter as practicable. The Registrant
hereby authorizes Jennifer Minter, Esq., to orally modify or withdraw this request for acceleration.
Please contact Jennifer Minter of Buchanan
Ingersoll & Rooney PC, counsel to the Company, at (412) 562-8444, or in her absence, Brian North at (215) 665-3828, to provide notice
of effectiveness, or if you have any other questions or concerns regarding this matter.
Sincerely yours,
Longeveron Inc.
By:
/s/ Wa’el Hashad
Wa’el Hashad
Chief Executive Officer
cc:
Jennifer Minter
Brian North
2023-11-16 - UPLOAD - Longeveron Inc.
United States securities and exchange commission logo
November 16, 2023
Wa’el Hashad
Chief Executive Officer
Longeveron Inc.
1951 NW 7th Avenue, Suite 520
Miami, Florida 33136
Re:Longeveron Inc.
Registration Statement on Form S-1
Filed November 15, 2023
File No. 333-275578
Dear Wa’el Hashad:
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: Jennifer Minter, Esq.
2023-08-11 - CORRESP - Longeveron Inc.
CORRESP
1
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LONGEVERON INC.
1951 NW 7th Avenue, Suite 520
Miami, Florida 33136
August 11, 2023
Via EDGAR Transmission
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Doris Stacey Gama
Laura Crotty
Re:
Longeveron Inc.
Registration Statement on Form S-1
File No. 333-272946
Request for Acceleration of Effectiveness
Dear Ms. Gama and Ms. Crotty:
In accordance with Rule 461 of Regulation C
of the General Rules and Regulations under the Securities Act of 1933, as amended, Longeveron Inc. (the “Registrant”) hereby
respectfully requests acceleration of the effective date of the above-referenced Registration Statement on Form S-1 (File No. 333-272946),
as amended, so that it may become effective on Monday, August 14, 2023, at 4:15 p.m., Eastern Time, or as soon thereafter as practicable.
The Registrant hereby authorizes Jennifer Minter, Esq., to orally modify or withdraw this request for acceleration.
Please contact Jennifer Minter of Buchanan
Ingersoll & Rooney PC, counsel to the Company, at (412) 562-8444, or in her absence, Richard DiStefano at (212) 440-4455, to provide
notice of effectiveness, or if you have any other questions or concerns regarding this matter.
Sincerely yours,
Longeveron Inc.
By:
/s/ Wa’el Hashad
Wa’el Hashad
Chief Executive Officer
cc:
Jennifer Minter
Richard DiStefano
2023-07-28 - CORRESP - Longeveron Inc.
CORRESP
1
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Longeveron Inc.
1951 NW 7th Avenue, Suite 520
Miami, Florida 33136
July 28, 2023
Division of Corporate Finance
Office of Life Sciences
U.S. Securities and Exchange Commission
Mail Stop 3720
100 F Street N.E.
Washington, D.C. 20005
Attn:
Doris Stacey Gama
Laura Crotty
Re:
Longeveron Inc.
Registration Statement on Form S-1
Filed June 27, 2023
File No. 333-272946
Dear Ms. Gama and Ms. Crotty:
We are writing in connection
with the above-captioned matter regarding the Registration Statement on Form S-1, File No. 333-272946, of Longeveron
Inc. (the “Company”) filed with the Securities and Exchange Commission (the “Commission”) on June 27, 2023 (the
“Form S-1”). We hereby provide supplementally the following responses in reply to the Staff’s comment letter dated July 11,
2023 (the “Comment Letter”). The numbered responses set forth below correspond to the numbering set forth in the Comment Letter.
For your convenience, we have included each of the Staff’s comments (in bold).
Cover Page
1. Please revise the heading on your cover page to quantify the volume of transferable subscription rights you will be registering.
Additionally, given this is not a firm commitment offering, shareholders may not exercise the entire amount distributed and R.F. Lafferty
& Co., Inc. is not required to arrange for the purchase and sale of any specific number or dollar amount of transferable subscription
rights, please delete the reference to the total amount of proceeds you may receive in the heading on the cover page.
Response: The Company has revised the cover page
of its Form S-1 to allow for inclusion of the quantity of the volume of transferable subscription rights the Company will be registering.
In addition, the Company has removed the reference to the total amount of proceeds that may be received in the heading on the cover page.
2. We note that R.F. Lafferty & Co., Inc. has agreed to use its “commercially reasonable efforts” to place any unsubscribed
shares for an additional period of up to 45 days. Please clarify whether “commercially reasonable” efforts differs from best
efforts. If so, please explain.
Response: The Company has revised the disclosure on the cover page
and on elsewhere in the Form S-1 to clarify that R.F. Lafferty & Co. has agreed to use best efforts to place any unsubscribed shares
for the additional 45 day period.
We hope that the foregoing is responsive to the Staff’s comments.
Please do not hesitate to contact our counsel, Jennifer Minter, Esq., at (412) 562-8444 if you have any questions regarding this matter.
Sincerely,
/s/ Wa’el Hashad
Wa’el Hashad
Chief Executive Officer
cc:
Jennifer R. Minter, Esq.
2023-07-11 - UPLOAD - Longeveron Inc.
United States securities and exchange commission logo
July 11, 2023
Wa'el Hashad
Chief Executive Officer
Longeveron Inc.
1951 NW 7th Ave, Suite 520
Miami, FL 33136
Re:Longeveron Inc.
Registration Statement on Form S-1
Filed June 7, 2023
File No. 333-272946
Dear Wa'el Hashad:
We have limited our review of your registration statement to those issues we have
addressed in our 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 June 27, 2023
Cover Page
1.Please revise the heading on your cover page to quantify the volume of transferable
subscription rights you will be registering. Additionally, given this is not a firm
commitment offering, shareholders may not exercise the entire amount distributed and
R.F. Lafferty & Co., Inc. is not required to arrange for the purchase and sale of any
specific number or dollar amount of transferable subscription rights, please delete the
reference to the total amount of proceeds you may receive in the heading on the cover
page.
2.We note that R.F. Lafferty & Co., Inc. has agreed to use its "commercially reasonable
efforts" to place any unsubscribed shares for an additional period of up to 45 days. Please
FirstName LastNameWa'el Hashad
Comapany NameLongeveron Inc.
July 11, 2023 Page 2
FirstName LastName
Wa'el Hashad
Longeveron Inc.
July 11, 2023
Page 2
clarify whether "commercially reasonable" efforts differs from best efforts. If so, please
explain.
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 Doris Stacey Gama at 202-551-3188 or Laura Crotty at 202-551-7614
with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jennifer M. Minter, Esq.
2022-04-12 - CORRESP - Longeveron Inc.
CORRESP
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LONGEVERON INC.
1951 NW 7th Avenue, Suite 520
Miami, Florida 33136
April 12, 2022
Via EDGAR Transmission
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Michael Davis
Christine Westbrook
Re:
Acceleration Request of Longeveron Inc.
Registration Statement on Form S-3,
Filed April 5, 2022
File No. 333-264142
Ladies and Gentlemen:
In accordance with Rule 461 of Regulation C of
the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request the acceleration of the effective date
of the above-referenced Registration Statement so that it will become effective on Thursday, April 14, 2022, at 4:30 p.m., Eastern Time,
or as soon thereafter as practicable. Please contact Brian North of Buchanan Ingersoll & Rooney PC, counsel to the Company, at (215)
665-3828, or in his absence, Jennifer Minter at (412) 562-8444, to provide notice of effectiveness, or if you have any other questions
or concerns regarding this matter.
Sincerely yours,
Longeveron Inc.
By:
/s/ Geoff Green
Geoff Green
Chief Executive Officer
cc:
Brian North
Jennifer Minter
2022-04-12 - UPLOAD - Longeveron Inc.
United States securities and exchange commission logo
April 12, 2022
Geoff Green
Chief Executive Officer
Longeveron Inc.
1951 NW 7th Avenue, Suite 520
Miami, FL 33136
Re:Longeveron Inc.
Registration Statement on Form S-3
Filed April 5, 2022
File No. 333-264142
Dear Mr. Green:
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 Michael Davis at 202-551-4385 or Christine Westbrook at 202-551-
5019 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Brian S. North, Esq.
2021-12-20 - CORRESP - Longeveron Inc.
CORRESP
1
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LONGEVERON INC.
1951 NW 7th Avenue, Suite 520
Miami, Florida 33136
December 20, 2021
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, D.C. 20549
Re: Longeveron Inc. (the “Company”)
Registration Statement on Form S-1 originally filed December
15, 2021
(File No. 333-261667) (the “Registration Statement”)
Ladies and Gentlemen:
The Company hereby requests, pursuant to Rule 461
promulgated under the Securities Act of 1933, as amended, acceleration of effectiveness of the Registration Statement so that such Registration
Statement will become effective as of 4:30 p.m. EDT on Wednesday December 22, 2021, or as soon thereafter as practicable.
The Company hereby acknowledges the following:
● should the Securities and Exchange Commission (the “Commission”) or the staff of the Commission
(the “Staff”), acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission
from taking any action with respect to the filing;
● the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the filing
effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing;
and
● the Company may not assert Staff comments and the declaration of effectiveness as a defense in any proceeding
initiated by the Commission or any person under the federal securities laws of the United States.
If you have any questions, please contact Jennifer
R Minter, Esq., at (412) 562-8444, from the Company’s outside legal counsel for this matter, Buchanan Ingersoll & Rooney PC.
Very truly yours,
LONGEVERON INC.
By:
/s/ Geoff Green
Geoff Green
Chief Executive Officer
2021-12-17 - UPLOAD - Longeveron Inc.
United States securities and exchange commission logo
December 17, 2021
Geoff Green
Chief Executive Officer
Longeveron Inc.
1951 NW 7th Avenue, Suite 520
Miami, Florida 33136
Re:Longeveron Inc.
Registration Statement on Form S-1
Filed December 15, 2021
File No. 333-261667
Dear Mr. Green:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jessica Ansart at (202) 551-4511 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jennifer Minter
2021-02-10 - CORRESP - Longeveron Inc.
CORRESP
1
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February 10, 2021
VIA EDGAR AND OVERNIGHT DELIVERY
Division of Corporation Finance
U.S. Securities & Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Re: LONGEVERON LLC
Amendment No. 2 to Registration Statement on Form
S-1
Filed February 8, 2021
File No. 333-252234
Ladies and Gentlemen:
On behalf of Longeveron LLC, a limited liability
company organized under the laws of Delaware and following a statutory conversion, a corporation organized under the laws of Delaware
(the “Company”), we are transmitting this letter in response to comments received from the staff
(the “Staff”) of the Securities and Exchange Commission by letter dated February 9, 2021 with respect
to the Company’s Registration Statement on Form S-1 (the “Registration Statement”). This letter
is being submitted together with an amendment (“Amendment No. 3”) to the Registration Statement, which
has been revised to address the Staff’s comments. The bold and numbered paragraphs below correspond to the numbered paragraphs
in the Staff’s letter and are followed by the Company’s responses. Unless otherwise indicated, capitalized terms used
herein have the meanings assigned to them in the Registration Statement.
Amendment No. 1 to
Registration Statement on Form S-1 filed February 3, 2021
About Our Indications,
page 3
1. Please revise your disclosure on pages 3, 4 and 88 to clarify that you have not yet submitted an orphan drug designation
request and that determinations as to whether ARDS and HLHS qualify as a "rare disease or condition" will be made on
the basis of the facts and circumstances as of the date the request for orphan drug designation is made.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has updated the disclosure in the
Registration Statement to clarify that the Company has not yet submitted an orphan drug designation request and that determinations
as to whether ARDS and HLHS qualify as a "rare disease or condition" will be made on the basis of the facts and circumstances
as of the date the request for orphan drug designation is made.
Summary
Financial Data
Statement
of Operations Data, page 9
2. Please revise your disclosures to present your per share amounts rounded to the nearest two
decimal places so as to not imply greater precision than exists.
Response: The Company
respectfully acknowledges the Staff’s comment and advises the Staff that it has updated the disclosure in the Registration
Statement to present your per share amounts rounded to the nearest two decimal places.
Balance
Sheet Data, page 10
3. Please revise to present the pro forma balance sheet data based on the latest balance sheet.
Refer to Rule 11-02(c) of Regulation S-X.
Response: The Company
respectfully acknowledges the Staff’s comment and advises the Staff that it has updated the presentation of the pro forma
balance sheet data based on the latest balance sheet.
Exhibits
4. We note that the legal opinion filed as Exhibit 5.1
opines on the validity of the Shares "when" they are issued "in total numbers that do not exceed the total number
of shares available under the Company’s certificate of incorporation." It is not appropriate for counsel to make an
assumption that assumes a material fact underlying the opinion. Please have your counsel provide an amended opinion, or advise.
See Section II.B.3 of Staff Legal Bulletin No. 19.
Response: The Company
respectfully acknowledges the Staff’s comment and advises the Staff that the legal opinion filed as Exhibit 5.1 has been
revised so as to address the Staff’s comment.
We hope that the
foregoing has been responsive to the Staff’s comments and look forward to resolving any outstanding issues as quickly as
possible. Please do not hesitate to contact me at 412-562-8444 with any questions or further comments you may have regarding this
filing or if you wish to discuss the above.
Sincerely,
/s/ Jennifer R. Minter
Jennifer R. Minter
Buchanan Ingersoll & Rooney PC
Enclosures
Cc (via email):
Geoff Green, Chief Executive Officer
James Clavijo, Chief Financial Officer
Joshua Hare, Chief Science Officer
Stephen E. Faucetta, Kingswood Capital Markets
Andrew Tucker, Nelson Mullins
Brian North, Buchanan Ingersoll & Rooney
2021-02-09 - UPLOAD - Longeveron Inc.
United States securities and exchange commission logo
February 9, 2021
Geoff Green
Chief Executive Officer
LONGEVERON LLC
1951 NW 7th Avenue
Suite 520
Miami, FL 33136
Re:LONGEVERON LLC
Amendment No. 2 to Form S-1
Filed February 8, 2021
File No. 333-252234
Dear Mr. Green:
We have reviewed your amended registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our [Month day, year] letter.
Amendment No. 1 to Registration Statement on Form S-1 filed February 3, 2021
About Our Indications, page 3
1.Please revise your disclosure on pages 3, 4 and 88 to clarify that you have not yet
submitted an orphan drug designation request and that determinations as to whether
ARDS and HLHS qualify as a "rare disease or condition" will be made on the basis of the
facts and circumstances as of the date the request for orphan drug designation is made.
Summary Financial Data
Statement of Operations Data, page 9
2.Please revise your disclosures to present your per share amounts rounded to
FirstName LastNameGeoff Green
Comapany NameLONGEVERON LLC
February 9, 2021 Page 2
FirstName LastName
Geoff Green
LONGEVERON LLC
February 9, 2021
Page 2
the nearest two decimal places so as to not imply greater precision than exists.
Balance Sheet Data, page 10
3.Please revise to present the pro forma balance sheet data based on the latest balance sheet.
Refer to Rule 11-02(c) of Regulation S-X.
Exhibits
4.We note that the legal opinion filed as Exhibit 5.1 opines on the validity of the Shares
"when" they are issued "in total numbers that do not exceed the total number of shares
available under the Company’s certificate of incorporation." It is not appropriate for
counsel to make an assumption that assumes a material fact underlying the opinion. Please
have your counsel provide an amended opinion, or advise. See Section II.B.3 of Staff
Legal Bulletin No. 19.
You may contact Li Xiao at 202-551-4391 or Lynn Dicker at 202-551-3616 if you have
questions regarding comments on the financial statements and related matters. Please contact
Deanna Virginio at _202-551-4530 or Suzanne Hayes at 202-551-3675 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jennifer Minter
2021-02-09 - CORRESP - Longeveron Inc.
CORRESP
1
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Personal and Confidential
February
8, 2021
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Attention: Ms.
Deanna Virginio
Re: Longeveron
LLC
Registration
Statement on Form S-1
Filed
February 3, 2021
File
No. 333-252232
Ladies
and Gentlemen:
In
accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), Kingswood Capital Markets, division
of Benchmark Investments, Inc., as representative of the several underwriters, hereby joins Longeveron LLC (the “Company”)
in requesting that the Securities and Exchange Commission take appropriate action to cause the Registration Statement on Form
S-1 (File No. 333-252234) (the “Registration Statement”) to become effective on Thursday, February 11, 2021, at 4:00
p.m., Eastern Time, or as soon thereafter as practicable, or at such other time as the Company or its outside counsel, Buchanan
Ingersoll & Rooney PC, request by telephone that such Registration Statement be declared effective.
Pursuant
to Rule 460 of the General Rules and Regulations of the Securities and Exchange Commission under the Act, we wish to advise you
that copies of the Company’s Preliminary Prospectus, dated February 3, 2021, were furnished to two underwriters and distributed
by the underwriter approximately as follows through the date hereof: 300+ copies to prospective underwriters, institutional investors,
dealers and others.
The
undersigned advises that it has complied and will continue to comply, and that it has been informed by the participating underwriters
and dealers that they have complied with and will continue to comply, with the requirements of Rule 15c2-8 under the Securities
Exchange Act of 1934, as amended.
Very truly yours,
KINGSWOOD CAPITAL MARKETS,
a division of Benchmark Investments, Inc.
By:
/s/ Sam Fleischman
Name:
Sam Fleischman
Title:
Supervisory Principal
2021-02-09 - CORRESP - Longeveron Inc.
CORRESP
1
filename1.htm
February
9, 2021
Via
EDGAR Transmission
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Mail
Stop 4720
Washington,
D.C. 20549
Attention:
Deanna Virginio
Re:
Longeveron, LLC
Registration
Statement on Form S-1
Filed January
19, 2021, as amended on February 3, 2021
and February 8, 2021
Registration
No. 333-252234
Dear
Ms. Virginio:
In
accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we
hereby request the acceleration of the effective date of the above-referenced Registration Statement so that it will become effective
on Thursday February 11, 2021, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, or at such later time as Longeveron,
LLC (the “Company”) or its counsel may request via telephone call to the staff. Please contact Brian North of Buchanan
Ingersoll & Rooney PC, counsel to the Company, at (215) 665-3828, or in his absence, Jennifer Minter at (412) 562-8444, to
provide notice of effectiveness, or if you have any other questions or concerns regarding this matter.
Sincerely
yours,
Longeveron,
LLC
By:
/s/
Geoff Green
Geoff
Green
Chief
Executive Officer
cc:
Brian
North
Jennifer Minter
2021-02-03 - CORRESP - Longeveron Inc.
CORRESP
1
filename1.htm
February 3, 2021
VIA EDGAR AND OVERNIGHT DELIVERY
Division of Corporation Finance
U.S. Securities & Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Re: LONGEVERON LLC
Registration Statement on Form S-1
File January 19, 2021
File No. 333-252234
Ladies and Gentlemen:
On behalf of Longeveron LLC, a limited liability
company organized under the laws of Delaware and following a statutory conversion, a corporation organized under the laws of Delaware
(the “Company”), we are transmitting this letter in response to comments received from the staff
(the “Staff”) of the Securities and Exchange Commission by letter dated February 1, 2021 with respect
to the Company’s Registration Statement on Form S-1 (the “Registration Statement”). This letter
is being submitted together with an amendment (“Amendment No. 1”) to the Registration Statement, which
has been revised to address the Staff’s comments. The bold and numbered paragraphs below correspond to the numbered paragraphs
in the Staff’s letter and are followed by the Company’s responses. Unless otherwise indicated, capitalized terms used
herein have the meanings assigned to them in the Registration Statement.
Registration Statement on Form -1
Executive and Director Compensation, page 113
1. Please update your compensation disclosures to provide information for the year ended December 31, 2020.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has updated the tables in the Registration
Statement in accordance with Item 402 of Regulation S-K and any accompanying footnotes or narrative so as to include compensation
for the year ended December 31, 2020.
We hope that
the foregoing has been responsive to the Staff’s comments and look forward to resolving any outstanding issues as quickly
as possible. Please do not hesitate to contact me at 412-562-8444 with any questions or further comments you may have regarding
this filing or if you wish to discuss the above.
Sincerely,
/s/ Jennifer R. Minter
Jennifer R. Minter
Buchanan Ingersoll & Rooney PC
Enclosures
Cc (via email):
Geoff Green, Chief Executive Officer
James Clavijo, Chief
Financial Officer
Joshua Hare, Chief
Science Officer
Stephen E. Faucetta,
Kingswood Capital Markets
Andrew Tucker, Nelson
Mullins
Brian North, Buchanan Ingersoll & Rooney
2021-02-01 - UPLOAD - Longeveron Inc.
United States securities and exchange commission logo
February 1, 2021
Geoff Green
Chief Executive Officer
LONGEVERON LLC
1951 NW 7th Avenue
Suite 520
Miami, FL 33136
Re:LONGEVERON LLC
Registration Statement on Form S-1
Filed January 19, 2021
File No. 333-252234
Dear Mr. Green:
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 January 19, 2021
Executive and Director Compensation, page 113
1.Please update your compensation disclosures to provide information for the year ended
December 31, 2020.
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
FirstName LastNameGeoff Green
Comapany NameLONGEVERON LLC
February 1, 2021 Page 2
FirstName LastName
Geoff Green
LONGEVERON LLC
February 1, 2021
Page 2
statement.
You may contact Li Xiao at 202-551-4391 or Lynn Dicker at 202-551-3616 if you have
questions regarding comments on the financial statements and related matters. Please contact
Deanna Virginio at 202-551-4530 or Suzanne Hayes at 202-551-3675 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jennifer Minter
2021-01-19 - CORRESP - Longeveron Inc.
CORRESP
1
filename1.htm
January
19, 2021
VIA
EDGAR AND OVERNIGHT DELIVERY
Division
of Corporation Finance
U.S. Securities & Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Re: LONGEVERON
LLC
Registration Statement on Form S-1
CIK No. 0001721484
Ladies
and Gentlemen:
On behalf of Longeveron LLC, a limited liability
company organized under the laws of Delaware and following a statutory conversion, a corporation organized under the laws of Delaware
(the “Company”), we are transmitting this letter in response to comments received from the staff
(the “Staff”) of the Securities and Exchange Commission (the “Commission”)
by letter dated January 14, 2021 with respect to the Company’s Confidential Amendment No. 1 Draft Registration Statement
on Form S-1 (the “Amended Draft Registration Statement”). This letter is being submitted simultaneously
with the Company’s filing of the above-captioned Registration Statement (the “Registration Statement”)
with the Commission, which has been revised to address the Staff’s comments. The bold and numbered paragraphs below correspond
to the numbered paragraphs in the Staff’s letter and are followed by the Company’s responses. For the Staff’s
convenience, we are also sending, by courier, copies of this letter and marked copies of the Registration Statement that reflect
changes made to the Amended Draft Registration Statement. Unless otherwise indicated, capitalized terms used herein have the meanings
assigned to them in the Registration Statement.
Amendment
No. 1 to Draft Registration Statement on Form -1
Clinical
Development Pipeline, page 2
1. We
note your revised pipeline graph in response to prior comment 2. Please tell us why the
status bar in the pipeline graph appears to indicate that the Phase 2 trial is ongoing,
while the text indicates it will begin in 2021.
Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has further clarified the pipeline
graph with respect to the Aging Frailty Phase 2 (Japan), by adjusting the relevant status bar to clarify that the Aging Frailty
Phase 2 (Japan) clinical trial is expected to be initiated in 2021, consistent with the narrative disclosure.
Holders
of our Class B common stock will control the direction of our business, page 41
2. We
note your revised disclosure in response to prior comment 8. Please revise the discussion
to identify the names of the four holders you reference.
Response:
The Company respectfully acknowledges the Staff’s comment, and has revised its disclosure so as to provide the names of
the two holders who are expected to collectively be in a position to exercise voting control of the Company’s securities
following the offering as a result of their current holdings. The remaining two holders originally referenced will own an immaterial
number of shares of Class B common stock following the offering, and as such their names have not been included.
Use
of Proceeds, page 50
3. We
note your revised disclosure in response to prior comment 10. Please also disclose the
approximate amount of net proceeds intended to be used for each purpose listed. We note
your disclosure that you do not anticipate the net proceeds from the offering will be
sufficient to complete any of the referenced trials that you intend to initiate. Please
clarify whether you expect the proceeds will be sufficient to complete the on-going trials
referenced.
Response:
The Company respectfully acknowledges the Staff’s comment, and has revised its use of proceeds disclosure so as to include
a table that will show the approximate amount of net proceeds intended to be used for each of the purposes listed, once pricing
information has been included. The Company has further clarified that it does expect that the proceeds from the offering will
be sufficient to complete the on-going trials referenced therein.
Management’s
Discussion and Analysis of Financial Conditions and Results of Operations Liquidity and Capital Resources, page 62
4. In
the Capitalization table you disclose that the accumulated deficit was $25,536,841 as
of September 30, 2020. Please revise to prominently provide that information in your
liquidity disclosures here.
Response:
The Company respectfully acknowledges the Staff’s comment, and has revised its disclosure within Management’s Discussion
and Analysis of Financial Condition and Results of Operations to provide the accumulated deficit amounts as of September 30, 2020.
License
Agreements and Strategic Collaborations, page 73
5. We
note your revised disclosure in response to prior comment 16 and 17. Please also disclose
the royalty term under each of the license agreements with UM and JMHMD.
Response:
The Company respectfully acknowledges the Staff’s comment, and has revised its disclosure regarding the license agreements
to disclose the royalty terms under each.
Interim
Financial Statements for the Nine Months ended September 30, 2020 Note 2. Summary of Significant Accounting Policies
Inventory,
page F-23
6. We
note your response to comment 21. Please remove the reference to the biological segment
here as well. Please also revise, where appropriate, to disclose your segment determination
as indicated in your response.
Response:
The Company respectfully acknowledges the Staff’s comment, and has updated its disclosure accordingly.
2
General
7. Please
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.
Response:
The Company respectfully acknowledges the Staff’s comment, and can confirm that it has spoken with the underwriters, and
confirmed that they have not provided any written communications (as defined in Rule 405) to potential investors to date in reliance
on Section 5(d) of the Securities Act.
We
hope that the foregoing has been responsive to the Staff’s comments and look forward to resolving any outstanding issues
as quickly as possible. Please do not hesitate to contact me at 412-562-8444 with any questions or further comments you may have
regarding this filing or if you wish to discuss the above.
Sincerely,
/s/
Jennifer R. Minter
Jennifer
R. Minter
Buchanan
Ingersoll & Rooney PC
Enclosures
Cc
(via email):
Geoff
Green, Chief Executive Officer
James Clavijo, Chief Financial Officer
Joshua
Hare, Chief Science Officer
Stephen
E. Faucetta, Kingswood Capital Markets
Andrew
Tucker, Nelson Mullins
Brian North, Buchanan Ingersoll & Rooney
3
2021-01-14 - UPLOAD - Longeveron Inc.
United States securities and exchange commission logo
January 14, 2021
Geoff Green
Chief Executive Officer
LONGEVERON LLC
1951 NW 7th Avenue
Suite 520
Miami, FL 33136
Re:LONGEVERON LLC
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted December 30, 2020
CIK No. 0001721484
Dear Mr. Green:
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
Clinical Development Pipeline, page 2
1.We note your revised pipeline graph in response to prior comment 2. Please tell us
why the status bar in the pipeline graph appears to indicate that the Phase 2 trial is
ongoing, while the text indicates it will begin in 2021.
Holders of our Class B common stock will control the direction of our business, page 41
2.We note your revised disclosure in response to prior comment 8. Please revise the
discussion to identify the names of the four holders you reference.
FirstName LastNameGeoff Green
Comapany NameLONGEVERON LLC
January 14, 2021 Page 2
FirstName LastNameGeoff Green
LONGEVERON LLC
January 14, 2021
Page 2
Use of Proceeds, page 50
3.We note your revised disclosure in response to prior comment 10. Please also disclose the
approximate amount of net proceeds intended to be used for each purpose listed. We note
your disclosure that you do not anticipate the net proceeds from the offering will be
sufficient to complete any of the referenced trials that you intend to initiate. Please clarify
whether you expect the proceeds will be sufficient to complete the on-going trials
referenced.
Management’s Discussion and Analysis of Financial Conditions and Results of Operations
Liquidity and Capital Resources, page 62
4.In the Capitalization table you disclose that the accumulated deficit was $25,536,841 as of
September 30, 2020. Please revise to prominently provide that information in your
liquidity disclosures here.
License Agreements and Strategic Collaborations, page 73
5.We note your revised disclosure in response to prior comment 16 and 17. Please also
disclose the royalty term under each of the license agreements with UM and JMHMD.
Interim Financial Statements for the Nine Months ended September 30, 2020
Note 2. Summary of Significant Accounting Policies
Inventory, page F-23
6.We note your response to comment 21. Please remove the reference to the biological
segment here as well. Please also revise, where appropriate, to disclose your segment
determination as indicated in your response.
General
7.Please 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.
You may contact Li Xiao at 202-5514391 or Lynn Dicker at 202-551-3616 if you have
questions regarding comments on the financial statements and related matters. Please contact
Deanna Virginio at 202-551-4530 or Suzanne Hayes at 202-551-3675 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
FirstName LastNameGeoff Green
Comapany NameLONGEVERON LLC
January 14, 2021 Page 3
FirstName LastName
Geoff Green
LONGEVERON LLC
January 14, 2021
Page 3
cc: Jennifer Minter
2020-12-10 - UPLOAD - Longeveron Inc.
United States securities and exchange commission logo
December 9, 2020
Geoff Green
Chief Executive Officer
LONGEVERON LLC
1951 NW 7th Avenue
Suite 520
Miami, FL 33136
Re:LONGEVERON LLC
Draft Registration Statement on Form S-1
Submitted November 12, 2020
CIK No. 0001721484
Dear Mr. Green:
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 filed November 12, 2020
Business Overview, page 1
1.We note your references on page 1 and elsewhere that "Lomecel-B has a high safety
profile." Please revise your disclosure here and throughout your prospectus to remove
your characterization of Lomecel-B as safe, as a determination of whether a product
candidate is safe is solely within the authority of the U.S. Food and Drug Administration
and comparable regulatory bodies. We will not object to statements that Lomecel-B
was well-tolerated or information about the number of treatment related serious adverse
events, but you should not state or imply that your product candidate is safe.
FirstName LastNameGeoff Green
Comapany NameLONGEVERON LLC
December 9, 2020 Page 2
FirstName LastNameGeoff Green
LONGEVERON LLC
December 9, 2020
Page 2
Clinical Development Pipeline, page 2
2.Please adjust the status bars in the pipeline graph, as appropriate, to illustrate your product
candidate's current status for each indication. For example, with respect to your Aging
Frailty indication, we note that your phase 2 trial is currently on-going, however, the
pipeline graph appears to indicate that the phase 2 trial has been completed.
3.With respect to the Bahamas Registry Trial, the table appears to indicate that the product
candidate has been approved but it is still described as a trial. Please revise your table to
remove the indication that the product has been approved or provide additional
clarification.
About Our Indications, page 3
4.We note your disclosure that there are no approved medications that can prevent, stop, or
reverse the progression of Alzheimer's disease. However, according to the alzheimer's
association website there appear to be two types of medications — cholinesterase
inhibitors and memantine — that have been approved by the FDA to treat the cognitive
symptoms of Alzheimer's disease. Please revise to clarify your statement or advise.
Financial Overview, page 4
5.Please balance your disclosure to also state that the Company has experienced significant
losses since inception and expects to incur additional losses in the future.
We have been funded in part by government and non-profit grant awards..., page 15
6.Please describe the material terms and provisions of grant, contracts and regulations you
must comply with for continued receipt of government and non-profit association
funding. Additionally, we note your Exhibit Index appears to indicate your intention not
to file the referenced contracts or funding agreements. Please provide us with an analysis
supporting your conclusion that your are not required to file them pursuant to Item 601 of
Regulation S-K.
Risks Related to Intellectual Property, page 20
7.We note that you may be subject to federal regulations, such as march-in rights. Please
provide additional disclosure regarding the technology or technologies subject to march-
in rights; the portion of your business that would be affected by the exercise of march-
in rights; and whether and how you may be compensated in the event such rights are
exercised.
Holders of our Class B common stock will control the direction of our business..., page 39
8.Please revise the discussion to identify the four holders you reference.
Industry and Other Data, page 48
FirstName LastNameGeoff Green
Comapany NameLONGEVERON LLC
December 9, 2020 Page 3
FirstName LastNameGeoff Green
LONGEVERON LLC
December 9, 2020
Page 3
9.Your statement that your internal company research as well as third party information
regarding market and industry data has not been independently verified and that the
accuracy and completeness of such information is not guaranteed implies a disclaimer of
responsibility with respect to such information. Please either delete the statement or
specifically state that you are liable for the information related to the market and industry
data and your internal company research.
Use of Proceeds, page 48
10.We note your disclosure that you intend to allocate a portion of the proceeds from the
offering to fund research, including clinical trials and product development for our
existing pipeline. Please revise your disclosure identify each of the indications you intend
to advance with the funds from the offering and how far in the development process for
each indication you estimate that the allocated proceeds from the offering will enable you
to reach.
Impact of COVID-19, page 54
11.We note your disclosure related to disruption in executing follow up visits and mitigation
efforts. To the extent you had participants drop out of clinical trials, were not able to
conduct follow up visits or need to increase the number of participants for any other
reason related to pandemic related disruptions, please expand your disclosure to discuss
these impacts and consider applicable risk factor disclosure.
Management’s Discussion and Analysis of Financial Conditions and Results of Operations
Results of Operations
Research and Development Expenses, page 57
12.Given the importance of your research and development expenses to your operations,
please consider including disaggregated disclosure of the nature of expenses incurred for
each period.
Emerging Growth Company Status, page 63
13.Here and on page 7 you state you have elected to take advantage of the extended transition
period for complying with new or revised accounting standards under Section 107(b) of
the JOBS Act. However, your risk factor disclosure on page 41 states that you have
irrevocably elected not to avail yourselves of this exemption from new or revised
accounting standards. Please correct these apparent inconsistencies. If you elect to opt
out of these provisions, please indicate as such on the cover page.
Our Strategy, page 64
14.Please remove statements that your grant funding awards "demonstrate the acceptance and
support by the scientific community, giving high credibility to our programs," as many
FirstName LastNameGeoff Green
Comapany NameLONGEVERON LLC
December 9, 2020 Page 4
FirstName LastNameGeoff Green
LONGEVERON LLC
December 9, 2020
Page 4
research programs supported by the scientific community fail to achieve FDA approval.
Clinical Development Pipeline, page 66
15.With respect to Aging Frailty and Metabolic Syndrome, please also include in your
discussion that according to the FDA, neither of such indications presently have
definitions that are acceptable for characterizing the conditions for regulatory purposes
and that the FDA and the Japanese PMDA have both indicated that the concept of
“Frailty” or the Metabolic Syndrome as an indication will require additional clinical data
and discussion before future pivotal trials and marketing authorization.
License Agreements and Strategic Collaborations, page 68
16.With respect to the License Agreement with the University of Miami, describe the nature
of the use granted. For example, were you granted a worldwide exclusive license to
develop and commercialize the intellectual property. Please also disclose the royalty term
and the termination provisions under the agreement and quantify amounts paid to date, if
any
17.With respect to the License Agreement with JMHMD Holdings, describe the nature of the
use granted. Please also disclosure the royalty term and termination provisions. We also
note your disclosure that there were no license fees due during the nine months ended
September 30, 2020 and 2019 pertaining to this agreement. Please revise your disclosure
to disclose the aggregate amounts paid under the agreement and potential milestone
payments, if any.
U.S. Phase 2b Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial, page 72
18.We note your discussion of the Phase 2b clinical trial for your Aging Frailty
Program. Please clarify whether there was a Phase Phase 2a trial and whether it has been
completed.
Lomecel-B for Hypoplastic Left Heart Syndrome (HLHS), page 81
19.We note your disclosure that HLHS is an ultra-rate indication and would therefore qualify
for an orphan drug designation and potentially for orphan drug exclusivity if FDA
approved and that you may have the opportunity to pursue one of the FDA’s expedited
review programs for this use. Please revise your disclosure to clarify, if true, that the FDA
has not given any indication as to whether your product candidate will receive
an orphan drug designation or exclusivity or be permitted to use expedited regulatory
pathways.
Experts, page 131
20.Your expert language here only refers to the financial statements at December 31, 2019
and for the year then ended. Please revise to cover the same periods as the auditor’s
report on page F-2.
FirstName LastNameGeoff Green
Comapany NameLONGEVERON LLC
December 9, 2020 Page 5
FirstName LastName
Geoff Green
LONGEVERON LLC
December 9, 2020
Page 5
Financial Statements
Note 2. Summary of Significant Accounting Policies
Inventory, page F-7
21.Here you refer to a biological segment of your operations. Please clarify for us, and revise
if necessary, whether you have reporting segments as defined under ASC 280. If so,
please provide the required disclosures under ASC 280-10-50.
Intangible Assets, page F-8
22.Here you disclose that intangible assets include legal costs incurred related to patents and
trademarks. You also disclose on page 55 that general and administrative expenses
include legal fees relating to intellectual property. Please reconcile the two statements for
us including clarifications for the nature of costs, and timing for asset recognition. Revise
your disclosures if necessary. Please cite the relevant accounting references in your
response.
Note 8. Commitments and Contingencies
Exclusive Licensing Agreements , page F-16
23.Please explain to us, and revise if necessary, how these licensing agreements contributed
to your intangible assets disclosed on page F-8. Also, revise to disclose where you have
included the annual fees paid under the UM agreement and the legal fees paid under the
CD271+ agreement in the financial statements.
Exhibits
24.Please file the promissory note evidencing the Company's PPP loan as an exhibit to the
registration statement, pursuant to Item 601(b)(10) of Regulation S-K. Alternatively,
please explain to us why such disclosure is not required.
You may contact Li Xiao at 202-5514391 or Lynn Dicker at 202-551-3616 if you have
questions regarding comments on the financial statements and related matters. Please contact
Deanna Virginio at 202-551-4530 or Suzanne Hayes at 202-551-3675 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences