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FibroBiologics, Inc.
Response Received
2 company response(s)
Medium - date proximity
↓
↓
FibroBiologics, Inc.
Response Received
1 company response(s)
High - file number match
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FibroBiologics, Inc.
Response Received
1 company response(s)
High - file number match
↓
FibroBiologics, Inc.
Response Received
3 company response(s)
Medium - date proximity
↓
↓
Company responded
2024-06-21
FibroBiologics, Inc.
Summary
Generating summary...
↓
FibroBiologics, Inc.
Response Received
3 company response(s)
High - file number match
↓
Company responded
2024-03-15
FibroBiologics, Inc.
References: February 26, 2024
↓
Company responded
2024-03-26
FibroBiologics, Inc.
References: March 25, 2024
↓
FibroBiologics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-03-25
FibroBiologics, Inc.
Summary
Generating summary...
FibroBiologics, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2024-01-22
FibroBiologics, Inc.
Summary
Generating summary...
FibroBiologics, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
FibroBiologics, Inc.
Response Received
1 company response(s)
Medium - date proximity
↓
Company responded
2023-11-07
FibroBiologics, Inc.
References: October 27, 2023
Summary
Generating summary...
FibroBiologics, Inc.
Awaiting Response
0 company response(s)
High
FibroBiologics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-06-23
FibroBiologics, Inc.
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-27 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2026-03-27 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2026-03-24 | SEC Comment Letter | FibroBiologics, Inc. | DE | 377-09156 | Read Filing View |
| 2025-02-06 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2025-02-06 | SEC Comment Letter | FibroBiologics, Inc. | DE | 333-284663 | Read Filing View |
| 2025-01-10 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2025-01-06 | SEC Comment Letter | FibroBiologics, Inc. | DE | 333-284077 | Read Filing View |
| 2024-06-21 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2024-06-21 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2024-06-18 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2024-06-17 | SEC Comment Letter | FibroBiologics, Inc. | DE | 377-07266 | Read Filing View |
| 2024-03-27 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2024-03-26 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2024-03-25 | SEC Comment Letter | FibroBiologics, Inc. | DE | 333-277019 | Read Filing View |
| 2024-03-15 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2024-02-26 | SEC Comment Letter | FibroBiologics, Inc. | DE | 333-277019 | Read Filing View |
| 2024-01-22 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2024-01-16 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2023-11-07 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2023-10-27 | SEC Comment Letter | FibroBiologics, Inc. | DE | 377-06725 | Read Filing View |
| 2023-09-11 | SEC Comment Letter | FibroBiologics, Inc. | DE | 377-06725 | Read Filing View |
| 2023-06-23 | SEC Comment Letter | FibroBiologics, Inc. | DE | 377-06725 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-24 | SEC Comment Letter | FibroBiologics, Inc. | DE | 377-09156 | Read Filing View |
| 2025-02-06 | SEC Comment Letter | FibroBiologics, Inc. | DE | 333-284663 | Read Filing View |
| 2025-01-06 | SEC Comment Letter | FibroBiologics, Inc. | DE | 333-284077 | Read Filing View |
| 2024-06-17 | SEC Comment Letter | FibroBiologics, Inc. | DE | 377-07266 | Read Filing View |
| 2024-03-25 | SEC Comment Letter | FibroBiologics, Inc. | DE | 333-277019 | Read Filing View |
| 2024-02-26 | SEC Comment Letter | FibroBiologics, Inc. | DE | 333-277019 | Read Filing View |
| 2023-10-27 | SEC Comment Letter | FibroBiologics, Inc. | DE | 377-06725 | Read Filing View |
| 2023-09-11 | SEC Comment Letter | FibroBiologics, Inc. | DE | 377-06725 | Read Filing View |
| 2023-06-23 | SEC Comment Letter | FibroBiologics, Inc. | DE | 377-06725 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-27 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2026-03-27 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2025-02-06 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2025-01-10 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2024-06-21 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2024-06-21 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2024-06-18 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2024-03-27 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2024-03-26 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2024-03-15 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2024-01-22 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2024-01-16 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
| 2023-11-07 | Company Response | FibroBiologics, Inc. | DE | N/A | Read Filing View |
2026-03-27 - CORRESP - FibroBiologics, Inc.
CORRESP 1 filename1.htm FIBROBIOLOGICS, INC. 455 E. Medical Center Blvd. Suite 300 Houston, Texas 77598 March 27, 2026 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 RE: FibroBiologics, Inc. (the "Company") Registration Statement on Form S-1 Filed March 27, 2026 File No. 333-294713 Ladies and Gentlemen: Pursuant to Rule 461(a) under the Securities Act of 1933, as amended, the Company hereby respectfully requests that the effective date of the Company's Registration Statement on Form S-1 (File No. 333-294713) be accelerated by the Securities and Exchange Commission to 5:15 P.M. (Eastern Time) on March 31, 2026, or as soon as practicable thereafter, unless the Company notifies you otherwise prior to such time. We request that we be notified of such effectiveness by a telephone call to Barrett S. DiPaolo of Sichenzia Ross Ference LLP at 646-810-2173, and that such effectiveness also be confirmed in writing. Very truly yours, FibroBiologics, Inc. By: /s/ Ruben A. Garcia Name: Ruben A. Garcia Title: General Counsel
2026-03-27 - CORRESP - FibroBiologics, Inc.
CORRESP
1
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March
27, 2026
VIA
EDGAR
U.S.
Securities and Exchange Commission
Division
of Corporation Finance
Washington,
DC 20549
Re:
FibroBiologics, Inc.
Registration Statement
on Form S-1 (File No. 333-294713), 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. 333-294713) (as amended, the " Registration Statement "),
hereby concurs in the request by FibroBiologics, Inc. that the effective date of the above-referenced registration statement be accelerated
to 5:15 P.M. (Eastern Time), or as soon as practicable thereafter, on March 31, 2026, 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 Silvera
Name:
Edward
Silvera
Title:
Co-Chief
Executive Officer
2026-03-24 - UPLOAD - FibroBiologics, Inc. File: 377-09156
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 24, 2026 Pete O Heeron Chief Executive Officer FibroBiologics, Inc. 455 E. Medical Center Blvd. Suite 300 Houston, TX 77598 Re: FibroBiologics, Inc. Draft Registration Statement on Form S-1 Submitted March 20, 2026 CIK No. 0001958777 Dear Pete O Heeron: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement and non-public draft submission on EDGAR 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 Daniel Crawford at 202-551-7767 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Barrett DiPaolo, Esq. </TEXT> </DOCUMENT>
2025-02-06 - CORRESP - FibroBiologics, Inc.
CORRESP
1
filename1.htm
FIBROBIOLOGICS,
INC.
455
E. Medical Center Blvd.
Suite
300
Houston,
Texas 77598
February
6, 2025
VIA
EDGAR
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:
FibroBiologics,
Inc. (the “Company”)
Registration
Statement on Form S-3
File
No. 333- 284663
Dear
Mr. Gorsky:
Pursuant
to Rule 461(a) under the Securities Act of 1933, as amended, the Company hereby respectfully requests that the effective date of the
Company’s Registration Statement on Form S-3 (File No. 333-284663) be accelerated by the Securities and Exchange Commission to
4:00 p.m. Washington D.C. time on February 10, 2025, or as soon as practicable thereafter, unless the Company notifies you otherwise
prior to such time.
We
request that we be notified of such effectiveness by a telephone call to Jeremy Cleveland at 650.687.4173 or Malory Thelen at 214.969.4826
of Jones Day, and that such effectiveness also be confirmed in writing.
Very
truly yours,
FibroBiologics,
Inc.
By:
/s/
Ruben A. Garcia
Name:
Ruben
A. Garcia
Title:
General
Counsel
2025-02-06 - UPLOAD - FibroBiologics, Inc. File: 333-284663
February 6, 2025
Pete O’Heeron
Chief Executive Officer
FibroBiologics, Inc.
455 E. Medical Center Blvd.
Suite 300
Houston, Texas 77598
Re:FibroBiologics, Inc.
Registration Statement on Form S-3
Filed February 3, 2025
File No. 333-284663
Dear Pete O’Heeron:
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:Jeremy W. Cleveland
2025-01-10 - CORRESP - FibroBiologics, Inc.
CORRESP
1
filename1.htm
FIBROBIOLOGICS,
INC.
455
E. Medical Center Blvd.
Suite
300
Houston,
Texas 77598
January
10, 2025
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Jessica
Dickerson
RE:
FibroBiologics,
Inc. (the “Company”)
Registration
Statement on Form S-1
File
No. 333- 284077
Dear
Mrs. Dickerson:
Pursuant
to Rule 461(a) under the Securities Act of 1933, as amended, the Company hereby respectfully requests that the effective date of the
Company’s Registration Statement on Form S-1 (File No. 333-284077) be accelerated by the Securities and Exchange Commission to
4:00 p.m. Washington D.C. time on January 14, 2025, or as soon as practicable thereafter, unless the Company notifies you otherwise prior
to such time.
We
request that we be notified of such effectiveness by a telephone call to Brian Fenske at (713) 651-5557 or Lee McIntyre at (713) 651-5328
of Norton Rose Fulbright (US) LLP, and that such effectiveness also be confirmed in writing.
Very
truly yours,
FibroBiologics,
Inc.
By:
/s/
Ruben A. Garcia
Name:
Ruben
A. Garcia
Title:
General
Counsel
2025-01-06 - UPLOAD - FibroBiologics, Inc. File: 333-284077
January 6, 2025
Pete O'Heeron
Chief Executive Officer
FibroBiologics, Inc.
455 E. Medical Center Blvd.
Suite 300
Houston, TX 77598
Re:FibroBiologics, Inc.
Registration Statement on Form S-1
Filed December 30, 2024
File No. 333-284077
Dear Pete O'Heeron:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jessica Dickerson at 202-551-8013 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Brian P. Fenske, Esq.
2024-06-21 - CORRESP - FibroBiologics, Inc.
CORRESP
1
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FIBROBIOLOGICS,
INC.
455
E. Medical Center Blvd.
Suite
300
Houston,
Texas 77598
June
21, 2024
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Doris
Stacey Gama
RE:
FibroBiologics,
Inc. (the “Company”)
Registration
Statement on Form S-1
File
No. 333-280303
Dear
Mrs. Gama:
Pursuant
to Rule 461(a) under the Securities Act of 1933, as amended, the Company hereby respectfully requests that the effective date of the
Company’s Registration Statement on Form S-1 (File No. 333-280303) be accelerated by the Securities and Exchange Commission to
5:00 p.m. Washington D.C. time on June 25, 2024, or as soon as practicable thereafter, unless the Company notifies you otherwise prior
to such time.
We
request that we be notified of such effectiveness by a telephone call to Brian Fenske at (713) 651-5557 or Lee McIntyre at (713) 651-5328
of Norton Rose Fulbright (US) LLP, and that such effectiveness also be confirmed in writing.
Very
truly yours,
FibroBiologics,
Inc.
By:
/s/
Mark Andersen
Name:
Mark
Andersen
Title:
Chief
Financial Officer
2024-06-21 - CORRESP - FibroBiologics, Inc.
CORRESP
1
filename1.htm
FIBROBIOLOGICS,
INC.
455
E. Medical Center Blvd.
Suite
300
Houston,
Texas 77598
June
21, 2024
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Doris
Stacey Gama
RE:
FibroBiologics,
Inc. (the “Company”)
Registration
Statement on Form S-1
File
No. 333-280303
Withdrawal
of Acceleration Request
Dear
Mrs. Gama:
Reference
is made to our letter filed as correspondence with the Securities and Exchange Commission via EDGAR on June 18, 2024 (the “Acceleration
Request”), in which we requested the acceleration of the effective date of the above-referenced Registration Statement on Form
S-1 (File No. 333-280303) (the “Registration Statement”), to 5:00 p.m. Washington D.C. time on June 21, 2024, or as soon
as practicable thereafter, pursuant to Rule 461(a) under the Securities Act of 1933, as amended. We are no longer requesting that the
Registration Statement be declared effective at such date and time and we hereby formally, and with immediate effect, withdraw our request
for acceleration of the effective date.
Please
direct any questions with respect to the withdrawal of the Acceleration Request of the Registration Statement
to Brian Fenske at (713) 651-5557 or Lee McIntyre at (713) 651-5328 of Norton Rose Fulbright (US) LLP.
Very
truly yours,
FibroBiologics,
Inc.
By:
/s/
Mark Andersen
Name:
Mark
Andersen
Title:
Chief
Financial Officer
2024-06-18 - CORRESP - FibroBiologics, Inc.
CORRESP
1
filename1.htm
FIBROBIOLOGICS,
INC.
455
E. Medical Center Blvd.
Suite
300
Houston,
Texas 77598
June
18, 2024
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Doris
Stacey Gama
RE:
FibroBiologics,
Inc. (the “Company”)
Registration
Statement on Form S-1
File
No. 333-280303
Dear
Mrs. Gama:
Pursuant
to Rule 461(a) under the Securities Act of 1933, as amended, the Company hereby respectfully requests that the effective date of the
Company’s Registration Statement on Form S-1 (File No. 333-280303) be accelerated by the Securities and Exchange Commission
to 5:00 p.m. Washington D.C. time on June 21, 2024, or as soon as practicable thereafter, unless the Company notifies you otherwise
prior to such time.
We
request that we be notified of such effectiveness by a telephone call to Brian Fenske at (713) 651-5557 or Lee McIntyre at (713) 651-5328
of Norton Rose Fulbright (US) LLP, and that such effectiveness also be confirmed in writing.
Very
truly yours,
FibroBiologics,
Inc.
By:
/s/
Mark Andersen
Name:
Mark
Andersen
Title:
Chief
Financial Officer
2024-06-17 - UPLOAD - FibroBiologics, Inc. File: 377-07266
United States securities and exchange commission logo
June 17, 2024
Pete O’Heeron
Chief Executive Officer
FibroBiologics, Inc.
455 E. Medical Center Blvd., Suite 300
Houston, TX 77598
Re:FibroBiologics, Inc.
Draft Registration Statement on Form S-1
Submitted June 10, 2024
CIK No. 0001958777
Dear Pete O’Heeron:
This is to advise you that we do not intend to review your registration statement.
We request that you publicly file your registration statement no later than 48 hours prior
to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for
acceleration. We remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
Please contact Doris Stacey Gama at 202-551-3188 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Brian P. Fenske, Esq.
2024-03-27 - CORRESP - FibroBiologics, Inc.
CORRESP
1
filename1.htm
FIBROBIOLOGICS,
INC.
455
E. Medical Center Blvd.
Suite
300
Houston,
Texas 77598
March
27, 2024
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Jimmy
(CF) McNamara
Laura
Crotty
RE:
FibroBiologics,
Inc. (the “Company”)
Registration
Statement on Form S-1
File
No. 333-277019
Dear
Mr. McNamara and Ms. Crotty:
Pursuant
to Rule 461(a) under the Securities Act of 1933, as amended, the Company hereby respectfully requests that the effective date of the
Company’s Registration Statement on Form S-1 (File No. 333-277019) be accelerated by the Securities and Exchange Commission to
4:00 p.m. Washington D.C. time on March 28, 2024, or as soon as practicable thereafter, unless the Company notifies you otherwise prior
to such time.
We
request that we be notified of such effectiveness by a telephone call to Brian Fenske at (713) 651-5557 or Lee McIntyre at (713) 651-5328
of Norton Rose Fulbright (US) LLP, and that such effectiveness also be confirmed in writing.
Very
truly yours,
FibroBiologics,
Inc.
By:
/s/
Pete O’Heeron
Name:
Pete O’Heeron
Title:
Chief Executive Officer
2024-03-26 - CORRESP - FibroBiologics, Inc.
CORRESP
1
filename1.htm
Norton
Rose Fulbright US LLP
Fulbright
Tower
1301
McKinney, Suite 5100
Houston,
Texas 77010-3095
nortonrosefulbright.com
Brian
P. Fenske
brian.fenske@nortonrosefulbright.com
Tel
+1 713 651 5557
March
26, 2024
VIA
EDGAR
Office
of Life Sciences
Division of Corporation Finance
Securities
and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Attention: Jimmy McNamara
Laura
Crotty
Re:
FibroBiologics,
Inc.
Amendment
No. 1 to Registration Statement on Form S-1
Filed
March 15, 2024
File
No. 333-277019
Ladies
and Gentlemen:
This
letter is submitted on behalf of FibroBiologics, Inc. (the “Company”) in response to comments of the staff
(the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with
respect to the Company’s Amendment No. 1 to Registration Statement on Form S-1 filed on March 15, 2024 (the “Registration
Statement”), as set forth in the Staff’s letter dated March 25, 2024 (the “Comment Letter”).
Set
forth below are the Company’s responses to the Staff’s comments in the Comment Letter. For reference purposes, the text of
the Staff’s comments is reproduced in bold below, followed by the Company’s response to the comment. The numbered paragraphs
below correspond to the numbered comments in the Comment Letter.
Additionally,
the Company is concurrently filing Amendment No. 2 to the Registration Statement (“Amendment No. 2”), which
reflects revisions in response to the Comment Letter and certain other updates.
Cover
Page
1.
We
note your disclosure in the Plan of Distribution on page 124 that GEM and GYBL are “underwriters” within the meaning
of Section 2(a)(11) of the Securities Act. Please disclose that GEM and GYBL are underwriters on the cover page.
Company
Response: In response to the Staff’s comment, the Company has revised the cover page to disclose that GEM and GYBL are “underwriters”
within the meaning of Section 2(a)(11) of the Securities Act.
General
2.
We
note your response to comment 3 and re-issue in part. Please disclose whether the Registered Stockholders engaged in any short selling
of the company’s securities or other hedging activities prior to entering into the GEM SPA.
Company
Response: Please note that the Registered Stockholders could not have engaged in any short selling of the Company’s securities
or other hedging activities prior to entering into the GEM SPA because the Company was not publicly listed prior to the execution of
the GEM SPA. That said, in response to the Staff’s comment, the Company has revised Amendment No. 2 in the Risk Factors and Plan
of Distribution sections to disclose the additional information requested above with respect to the activities of the Registered Stockholders.
Remainder
of page intentionally blank. Signature page follows.
Should
the Staff have additional questions or comments regarding this submission, please do not hesitate to contact the undersigned at (713)
651-5557 or brian.fenske@nortonrosefulbright.com.
Sincerely,
NORTON
ROSE FULBRIGHT US LLP
/s/
Brian
P. Fenske
cc:
Pete
O’Heeron, Chief Executive Officer
Mark
Andersen, Chief Financial Officer
FibroBiologics,
Inc.
Lee
McIntyre
Norton
Rose Fulbright US LLP
2024-03-25 - UPLOAD - FibroBiologics, Inc. File: 333-277019
United States securities and exchange commission logo
March 25, 2024
Mark Andersen
Chief Financial Officer
FibroBiologics, Inc.
455 E. Medical Center Blvd.
Suite 300
Houston, Texas 77598
Re:FibroBiologics, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed March 15, 2024
File No. 333-277019
Dear Mark Andersen:
We have reviewed your amended registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies to your facts and circumstances
or do not believe an amendment is appropriate, please tell us why in your response.
After reviewing any amendment to your registration statement and the information you
provide in response to this letter, we may have additional comments. Unless we note otherwise,
any references to prior comments are to comments in our February 26, 2024, letter.
Amendment No. 1 to Registration Statement on Form S-1
Cover Page
1.We note your disclosure in the Plan of Distribution on page 124 that GEM and GYBL are
“underwriters” within the meaning of Section 2(a)(11) of the Securities Act. Please
disclose that GEM and GYBL are underwriters on the cover page.
General
2.We note your response to comment 3 and re-issue in part. Please disclose whether the
Registered Stockholders engaged in any short selling of the company’s securities or other
hedging activities prior to entering into the GEM SPA.
FirstName LastNameMark Andersen
Comapany NameFibroBiologics, Inc.
March 25, 2024 Page 2
FirstName LastName
Mark Andersen
FibroBiologics, Inc.
March 25, 2024
Page 2
Please contact Jimmy (CF) McNamara at 202-551-7349 or Laura Crotty at 202-551-7614
with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Brian Fenske
2024-03-15 - CORRESP - FibroBiologics, Inc.
CORRESP
1
filename1.htm
Norton
Rose Fulbright US LLP
Fulbright
Tower
1301
McKinney, Suite 5100
Houston,
Texas 77010-3095
nortonrosefulbright.com
Brian P. Fenske
brian.fenske@nortonrosefulbright.com
Tel +1 713 651 5557
March
15, 2024
VIA
EDGAR
Office
of Life Sciences
Division
of Corporation Finance
Securities
and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Jimmy McNamara
Laura
Crotty
Re:
FibroBiologics,
Inc.
Registration
Statement on Form S-1
Filed
February 12, 2024
File
No. 333-277019
Ladies
and Gentlemen:
This
letter is submitted on behalf of FibroBiologics, Inc. (the “Company”) in response to comments of the staff
(the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with
respect to the Company’s Registration Statement on Form S-1 filed on February 12, 2024 (the “Registration Statement”),
as set forth in the Staff’s letter dated February 26, 2024 (the “Comment Letter”).
Set
forth below are the Company’s responses to the Staff’s comments in the Comment Letter. For reference purposes, the text of
the Staff’s comments are reproduced in bold below, followed by the Company’s response to the comment. The numbered paragraphs
below correspond to the numbered comments in the Comment Letter.
Additionally,
the Company is concurrently filing Amendment No. 1 to the Registration Statement (“Amendment No. 1”), which
reflects revisions in response to the Comment Letter and certain other updates. For the convenience of the Staff, we are also sending,
by overnight courier, copies of this letter and copies of Amendment No. 1, marked to show changes to the Registration Statement as originally
filed.
Cover
Page
1.
Please
revise the cover page to identify the parties comprising the “Registered Stockholders”. In this regard we note that the
table on page 115 lists only GEM Global Yield LLC SCS under the heading “Registered Stockholders” and no other parties.
In the event GEM Global Yield LLC SCS is the only selling stockholder, please clarify this point throughout the prospectus.
Company
Response: In response to the Staff’s comment, the Company has revised the cover page and pages 112-113 of Amendment
No. 1 to identify GEM Global Yield LLC SCS and GEM Yield Bahamas Limited as the Registered Stockholders.
Exhibit
Index, page II-5
2.
Please
ensure each exhibit is in the proper text-searchable format. See Item 301 of Regulation S-T. Please re-file the respective exhibits
to your registration statement.
Company
Response: In response to the Staff’s comment, the Company has re-filed the exhibits or restored links to the exhibits as needed
to ensure that each exhibit is in proper text-searchable format.
General
3.
Please
revise your prospectus to disclose the following information with respect to the Share Purchase Agreement by and among the company
and GEM Global Yield LLC SCS and GEM Yield Bahamas Limited:
● the
material terms of the agreement, including the full discounted price (or formula for determining
it) at which GEM will receive the shares.
● the
material risks of an investment in the company and in the offering, including:
○ the
dilutive effect of the formula or pricing mechanism on the company’s share price;
○ the
possibility that the company may not have access to the full amount available to it under
the agreement; and
○ whether
an investor can engage in short-selling activities and, if so, how any sales activities after
announcement of a put may negatively affect the company’s share price.
● the
material market activities of GEM, including:
○ any
short selling of the company’s securities or other hedging activities that GEM may
or has engaged in, including prior to entering into the agreement and prior to the receipt
of any shares pursuant to the terms of the agreement; and
○ how
GEM intends to distribute the securities it owns or will acquire.
● how
the provisions of Regulation M may prohibit GEM and any other distribution participants that
are participating in the distribution of the company’s securities from:
○ engaging
in market making activities (e.g., placing bids or making purchases to stabilize the price
of the common stock) while the agreement is in effect; and
○ purchasing
shares in the open market while the agreement is in effect.
Company
Response: In response to the Staff’s comment, the Company has revised Amendment No. 1 in the Risk Factors and Plan of Distribution
to disclose the additional information requested above with respect to the GEM Share Purchase Agreement.
4.
We
note the company issued a draw-down notice under the GEM SPA to have GEM purchase up to 900,000 shares of common stock at a draw-down
threshold price of no less than $15.00 per share, and that the company submitted a closing notice after 65,447 shares of common stock
were purchased in a private placement at $15.00 per share. Please revise your disclosure, where appropriate, to explain why GEM did
not purchase the entire 900,000 shares contained in the draw-down notice.
Company
Response: In response to the Staff’s comment, the Company has revised Amendment No.1 on the cover page and elsewhere to disclose
why GEM did not purchase the entire 900,000 shares contained in the draw-down notice.
Remainder
of page intentionally blank. Signature page follows.
Should
the Staff have additional questions or comments regarding this submission, please do not hesitate to contact the undersigned at (713)
651-5557 or brian.fenske@nortonrosefulbright.com.
Sincerely,
NORTON
ROSE FULBRIGHT US LLP
/s/
Brian
P. Fenske
Brian
P. Fenske
Enclosure
cc:
Pete
O’Heeron, Chief Executive Officer
Mark
Andersen, Chief Financial Officer
FibroBiologics,
Inc.
Lee
McIntyre
Norton
Rose Fulbright US LLP
2024-02-26 - UPLOAD - FibroBiologics, Inc. File: 333-277019
United States securities and exchange commission logo
February 26, 2024
Mark Andersen
Chief Financial Officer
FibroBiologics, Inc.
455 E. Medical Center Blvd.
Suite 300
Houston, Texas 77598
Re:FibroBiologics, Inc.
Registration Statement on Form S-1
Filed February 12, 2024
File No. 333-277019
Dear Mark Andersen:
We have conducted a limited review of your registration statement and have the
following comments.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies to your facts and circumstances
or do not believe an amendment is appropriate, please tell us why in your response.
After reviewing any amendment to your registration statement and the information you
provide in response to this letter, we may have additional comments.
Registration Statement on Form S-1
Cover Page
1.Please revise the cover page to identify the parties comprising the "Registered
Stockholders". In this regard we note that the table on page 115 lists only GEM Global
Yield LLC SCS under the heading "Registered Stockholders" and no other parties. In the
event GEM Global Yield LLC SCS is the only selling stockholder, please clarify this
point throughout the prospectus.
Exhibit Index, page II-5
2.Please ensure each exhibit is in the proper text-searchable format. See Item 301 of
Regulation S-T. Please re-file the respective exhibits to your registration statement.
FirstName LastNameMark Andersen
Comapany NameFibroBiologics, Inc.
February 26, 2024 Page 2
FirstName LastNameMark Andersen
FibroBiologics, Inc.
February 26, 2024
Page 2
General
3.Please revise your prospectus to disclose the following information with respect to the
Share Purchase Agreement by and among the company and GEM Global Yield LLC SCS
and GEM Yield Bahamas Limited:
•the material terms of the agreement, including the full discounted price (or formula
for determining it) at which GEM will receive the shares.
•the material risks of an investment in the company and in the offering, including:othe dilutive effect of the formula or pricing mechanism on the company’s share
price;
othe possibility that the company may not have access to the full amount
available to it under the agreement; and
owhether an investor can engage in short-selling activities and, if so, how any
sales activities after announcement of a put may negatively affect the
company’s share price.
•the material market activities of GEM, including:oany short selling of the company’s securities or other hedging activities that
GEM may or has engaged in, including prior to entering into the agreement and
prior to the receipt of any shares pursuant to the terms of the agreement; and
ohow GEM intends to distribute the securities it owns or will acquire.
•how the provisions of Regulation M may prohibit GEM and any other distribution
participants that are participating in the distribution of the company’s securities from:oengaging in market making activities (e.g., placing bids or making purchases to
stabilize the price of the common stock) while the agreement is in effect; and
opurchasing shares in the open market while the agreement is in effect.
4.We note the company issued a draw-down notice under the GEM SPA to have GEM
purchase up to 900,000 shares of common stock at a draw-down threshold price of no less
than $15.00 per share, and that the company submitted a closing notice after 65,447 shares
of common stock were purchased in a private placement at $15.00 per share. Please revise
your disclosure, where appropriate, to explain why GEM did not purchase the entire
900,000 shares contained in the draw-down notice.
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.
FirstName LastNameMark Andersen
Comapany NameFibroBiologics, Inc.
February 26, 2024 Page 3
FirstName LastName
Mark Andersen
FibroBiologics, Inc.
February 26, 2024
Page 3
Please contact Jimmy (CF) McNamara at 202-551-7349 or Laura Crotty at 202-551-7614
with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Brian Fenske
2024-01-22 - CORRESP - FibroBiologics, Inc.
CORRESP
1
filename1.htm
FIBROBIOLOGICS,
INC.
455
E. Medical Center Blvd.
Suite
300
Houston,
Texas 77598
January
22, 2024
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Division
of Corporation Finance
Office
of Life Sciences
Attention:
Tim
Buchmiller
Cindy
Polynice
Joe
McCann
RE:
FibroBiologics,
Inc. (the “Company”)
Registration
Statement on Form S-1
File
No. 333-275361
Dear
Mr. Buchmiller, Ms. Polynice and Mr. McCann:
Pursuant
to Rule 461(a) under the Securities Act of 1933, as amended, the Company hereby respectfully requests that the effective date of the
Company’s Registration Statement on Form S-1 (File No. 333-275361) be accelerated by the Securities and Exchange Commission to
4:00 p.m. Washington D.C. time on January 24, 2024, or as soon as practicable thereafter, unless the Company notifies you otherwise
prior to such time.
We
request that we be notified of such effectiveness by a telephone call to Brian Fenske at (713) 651-5557 or Lee McIntyre at (713) 651-5328
of Norton Rose Fulbright (US) LLP, and that such effectiveness also be confirmed in writing.
Very
truly yours,
FibroBiologics,
Inc.
By:
/s/
Pete O’Heeran
Name:
Pete O’Heeran
Title:
Chief Executive Officer
2024-01-16 - CORRESP - FibroBiologics, Inc.
CORRESP
1
filename1.htm
CONFIDENTIAL
TREATMENT REQUESTED
BY
FIBROBIOLOGICS INC.: FIBR-0001
CERTAIN
PORTIONS OF THIS LETTER HAVE BEEN OMITTED FROM THE VERSION FILED VIA EDGAR. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS. INFORMATION THAT WAS OMITTED IN THE EDGAR VERSION HAS BEEN NOTED IN THIS LETTER WITH A PLACEHOLDER IDENTIFIED BY
THE MARK “[***]”.
FOIA
CONFIDENTIAL TREATMENT REQUESTED
The
entity requesting confidential treatment is:
FibroBiologics
Inc.
455
E. Medical Center Blvd.
Suite
300
Houston,
Texas 77598
Phone:
(281) 671-5150
Rule
83 Confidential Treatment Request
January
16, 2024
By
Secured Electronic Transmission and Edgar
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, NE
Washington,
DC 20549
Attention:
Cindy Polynice
Joe McCann
Tracie Mariner
Angela Connell
Re:
FibroBiologics Inc.
Registration Statement on Form S-1
File Number: 333-275361
CIK No. 0001958777
Ladies
and Gentlemen:
We
are submitting this letter on behalf of FibroBiologics Inc. (the “Company”), in connection with the review by the
staff (the “Staff”) of the Securities and Exchange Commission (the “SEC” or the “Commission”)
of the Company’s Registration Statement on Form S-1 (File No. 333-275361) initially filed on November 7, 2023 (the “Registration
Statement”). The purpose of this letter is to respond to Comment 27 of the Staff’s letter of June 23, 2023, regarding
the Registration Statement. For your convenience, your original comment appears in bold text, followed by our response.
Because
of the commercially sensitive nature of information contained herein, this submission is accompanied by the Company’s request for
confidential treatment for selected portions of this letter. The Company has filed a separate letter with the Office of Freedom of Information
and Privacy Act Operations in connection with the confidential treatment request, pursuant to Rule 83 of the Commission’s Rules
on Information and Requests, 17 C.F.R. § 200.83. For the Staff’s reference, we have enclosed a copy of the Company’s
letter to the Office of Freedom of Information and Privacy Act Operations, as well as a copy of this correspondence, marked to show the
portions redacted from the version filed via EDGAR and for which the Company is requesting confidential treatment.
455
E. Medical Center Blvd.
Suite
300
Houston,
TX 77598
(281)
671-5150
www.Fibrobiologics.com
CONFIDENTIAL
TREATMENT REQUESTED
BY
FIBROBIOLOGICS INC.: FIBR-0001
Financial
Statements, page F-1
Note
11- Share-based Compensation, page F-14
27.
Once you have an estimated offering price or range, please explain to us how you determined the fair value of the common stock underlying
your equity issuances and the reasons for any differences between the recent valuations of your common stock leading up to the IPO and
the estimated offering price. This information will help facilitate our review of your accounting for equity issuances. Please discuss
with the staff how to submit your response.
The
Company submits the below additional information to assist the Staff in its review of the Company’s position with respect to its
determination of the fair value of the shares of its common stock underlying its outstanding equity awards and the reasons for the difference
between the recent valuations of its common stock and the estimated offering price for its direct listing on the Nasdaq Global Market,
or Nasdaq.
The
Company advises the Staff that the Company effected a 1-for-4 reverse stock split on October 31, 2013 (the “Reverse Stock Split”).
The Company has reflected the Reverse Stock Split in the Registration Statement. Accordingly, all numbers of shares and per share values
in this letter are presented on a post-split retroactive basis to reflect the Reverse Stock Split.
Preliminary
Direct Listing Current Reference Price Range
The
Company advises the Staff that it has preliminarily estimated a direct listing Current Reference Price1
in a range of approximately $[***] to $[***] per share (the “Price Range”) for its direct
listing. The Price Range does not take into account the current lack of liquidity for the Company’s common stock and assumes a
successful direct listing, with no weighting attributed to any other outcome for the Company’s business, such as remaining as a
privately held company or being sold in a change of control transaction.
As
is typical in a direct listing, the Price Range was not derived using a formal determination of fair value, but was determined through
discussions among the board of directors of the Company (the “Board”), senior management of the Company and representatives
of Maxim Group LLC, the Company’s financial advisor (“Advisor”). Among the factors that were considered in estimating
the Price Range were the following:
●
the
general conditions of the securities market and the recent market prices of, and the demand for, publicly traded common stock of
comparable companies;
●
the
Company’s financial position and prospects;
●
progress
and stage of development of the Company’s products and brand;
1
Once our Advisor (defined below) has notified
Nasdaq that our shares of common stock are ready to trade, Nasdaq will confirm the Current Reference Price for our shares of common stock,
in accordance with Nasdaq rules. Under Nasdaq rules, the “Current Reference Price” means: (i) the single price at
which the maximum number of orders to buy or sell can be matched; (ii) if there is more than one price at which the maximum number of
orders to buy or sell can be matched, then it is the price that minimizes the imbalance between orders to buy or sell (i.e. minimizes
the number of shares that would remain unmatched at such price); (iii) if more than one price exists under (ii), then it is the entered
price (i.e. the specified price entered in an order by a customer to buy or sell) at which our shares of common stock will remain unmatched
(i.e. will not be bought or sold); and (iv) if more than one price exists under (iii), a price determined by Nasdaq in consultation with
the Advisor in its capacity as our financial advisor.
455
E. Medical Center Blvd.
Suite
300
Houston,
TX 77598
(281)
671-5150
www.Fibrobiologics.com
CONFIDENTIAL
TREATMENT REQUESTED
BY
FIBROBIOLOGICS INC.: FIBR-0001
●
an
analysis of the typical valuation ranges seen in recent direct listings and initial public offering (“IPO”) for
comparable companies in the Company’s industry;
●
the
general conditions of the securities market and the recent market prices of, and the demand for, publicly traded common stock of
comparable companies;
● an
assumption that there would be a receptive public trading market for the Company’s
brand name;
● an
assumption that there would be sufficient demand for the Company’s common stock to
support an offering of the size contemplated by the Company; and
●
the
recent performance of direct listings and IPOs of companies in the industry in which the Company operates.
The
actual Current Reference Price will not be set until the first day of trading of the Company’s common stock on Nasdaq, and remains
subject to change based on developments in the Company’s business, market conditions and other factors that are outside of the
Company’s control. However, the Company believes that the actual Current Reference Price will be within the Price Range.
Summary
of Recent Equity Awards
The
table below is a list of the options to purchase shares of our common stock granted to our Board of Directors (“Board”),
Scientific Advisory Board members and employees in September 2022 and February 2023:
Grant Date
Class of Grantees
Number of Shares
of Common Stock Granted
Exercise Price
Estimated
Fair Value Per
Share of
Common Stock
Grant
Date Fair
Value Per
Option
9/26/2022
Board of Directors
25,000
$ 3.28
$ 3.28
$ 2.56
9/26/2022
Scientific Advisory Board
56,250
$ 3.28
$ 3.28
$ 2.64 to $2.68
9/26/2022
Employees
20,000
$ 3.28
$ 3.28
$ 2.64
to $2.68
2/17/2023
Board of Directors
926,500
$ 2.28
$ 2.28
$ 1.80
2/17/2023
Employees
2,763,250
$ 2.28
$ 2.28
$ 1.80
455
E. Medical Center Blvd.
Suite
300
Houston,
TX 77598
(281)
671-5150
www.Fibrobiologics.com
CONFIDENTIAL
TREATMENT REQUESTED
BY
FIBROBIOLOGICS INC.: FIBR-0001
Summary
of Recent Equity Issuances Prior to the Direct Listing
In
December 2022, we issued an aggregate of the equivalent of 381,658 shares of Series B Preferred Stock to investors in a private placement,
at a price of the equivalent of $6.76 per share as to the equivalent of 318,049 shares, with the remaining equivalent of 63,609 shares
being bonus shares.
From
February 2023 through April 2023, we issued an aggregate of the equivalent of 890,310 shares of Series B Preferred Stock to investors
in a Regulation Crowdfunding offering, at a price of the equivalent of $6.76 per share as to the equivalent of 724,937 shares, with the
remaining equivalent of 143,225 shares and equivalent of 22,148 shares being bonus shares and commission payment shares, respectively.
In
March and April 2023, we issued the equivalent of 1,680,084 shares of Series B Preferred Stock to investors in private placements, at
a price of the equivalent of $6.76 per share as to the equivalent of 1,527,349 shares, with the remaining equivalent of 152,735 shares
being bonus shares.
In
April 2023 through September 2023, we issued the equivalent of 74,922 shares of Series B-1 Preferred Stock to investors in a private
placement, at prices ranging from the equivalent of $18.00 to the equivalent of $20.00 per share as to the equivalent of 64,070 shares,
with the remaining equivalent of 10,852 shares being bonus shares. In connection with a portion of such private placement of our Series
B-1 Preferred Stock, we also agreed to issue warrants, exercisable for a period of three years from our Direct Listing, to purchase an
aggregate of the equivalent of an aggregate of 8,890 shares of our common stock at an exercise price of the equivalent of $20.00 per
share. In November 2023, the Company issued a total of 14,859 additional shares and 1,431 additional warrants to investors who subscribed
to purchase shares of Series B-1 Preferred Stock at a price per share that exceeded the reference price per share expected in the Direct
Listing. The net effect of issuing additional shares and warrants to Series B-1 investors was to issue the shares at the reference price
per share expected in the direct listing plus any incentives in bonus shares and/or warrants they would have received for buying shares
prior to the direct listing without the liquidity of publicly traded shares.
Determining
the Fair Value of Common Stock Prior to the Direct Listing for Stock Option Grants
As
there has been no public market for the Company’s common stock to date, the estimated fair value of our common stock was determined
by the Board, with input from the Company’s management, based on common stock valuations prepared by an independent valuation firm
(the “Independent Valuation Firm”), meeting the requirements of Section 409A (“Section 409A”) of
the United States Tax Code (the “Code”), for tax planning and financial reporting purposes in recognition of Section
409A and FASB Accounting Standards Codification Topic 718 – Stock Compensation (“ASC 718”). The analysis
used to prepare the valuations was prepared following the guidance of the American Institute of Certified Public Accountants (“AICPA”)
Accounting and Valuation Guide: Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the “AICPA Guide”).
Specifically,
the option grants described in the table above which took place on September 26, 2022 (the “2022 Options”), were based
on a common stock valuation prepared for the purposes of Section 409A and ASC 718, by the Independent Valuation Firm, dated September
22, 2022 (with a valuation date of August 18, 2022) (the “2022 Valuation”). Pursuant to the 2022 Valuation, the Independent
Valuation Firm opined that the fair market value of a share of the Company’s common stock on a non-marketable, minority basis as
of August 18, 2022, was $3.28 per share, which the Board of Directors determined was still the fair value of one share of the Company’s
common stock on September 26, 2022, the date the 2022 Options were granted.
The
option grants described in the table above which took place on February 17, 2023 (the “2023 Options”, and together
with the 2022 Options, the “Options”), were based on a common stock valuation prepared for the purposes of Section
409A and ASC 718, by the Independent Valuation Firm, dated February 2, 2023 (with a valuation date of January 21, 2023)(the “2023
Valuation” and together with the 2022 Valuation, the “409A Valuations”). Pursuant to the 2023 Valuation,
the Independent Valuation Firm opined that the fair market value of a share of the Company’s common stock on a non-marketable,
minority basis as of January 21, 2023, was $2.28 per share, which the Board of Directors determined was still the fair value of one share
of the Company’s common stock on February 17, 2023, the date the 2023 Options were granted.
455 E. Medical Center Blvd.
Suite
300
Houston,
TX 77598
(281)
671-5150
www.Fibrobiologics.com
CONFIDENTIAL TREATMENT REQUESTED
BY FIBROBIOLOGICS INC.: FIBR-0001
The
409A Valuations were based on, among other things, a marketability discount and valuation methodology as discussed in greater detail
below.
Marketability
Discount
In
determining the estimated fair value of common stock on the date of a grant, it is appropriate to consider that the security may not
be freely tradeable in the public markets. The estimated fair value of the common stock of the Company on September 26, 2022 and February
17, 2023, therefore, reflects a discount for lack of marketability (“DLOM”), which considers that the Company is a
closely held entity with a diversified shareholder base and is partially based on the anticipated likelihood and timing of a future liquidity
event for the subject shares.
Section
409A regulations provide a presumption of reasonableness to valuations of stock that are not publicly traded and are issued “as
of a date that is no more than 12 months before the relevant transaction to which the valuation is applied (for example, the date of
grant of a stock option)”, unless a material event occurs that would affect such valuation. The Options were each granted within
a short period of time (39 days for the 2022 Options and 27 days for the 2023 Options) from the effective dates of the third-party 409A
Valuations, which the Company believes meets the safe harbor set forth in Section 409A, as to the Company’s good faith belief,
that the 409A Valuations meet the requirements of Section 401(a)(28)(C) of the Code.
Description
of Valuation Methodologies
Historically,
the Company has issued equity-based awards in the form of option awards. The fair values of the option awards were estimated based on
the date of grant using a Black-Scholes pricing model, which uses as inputs the fair value of the Company’s common stock and assumptions
the Company makes for the volatility of its common stock, the expected term of its stock options, the risk-free interest rate for a period
that approximates the expected term of the Company’s stock options and
2023-11-07 - CORRESP - FibroBiologics, Inc.
CORRESP
1
filename1.htm
Norton
Rose Fulbright US LLP
Fulbright
Tower
1301
McKinney, Suite 5100
Houston,
Texas 77010-3095
nortonrosefulbright.com
Brian
P. Fenske
brian.fenske@nortonrosefulbright.com
Tel
+1 713 651 5557
November
7, 2023
VIA
EDGAR AND OVERNIGHT COURIER
Office
of Life Sciences
Division
of Corporation Finance
Securities
and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Attention:
Cindy Polynice
Joe
McCann
Tracie
Mariner
Angela
Connell
Re:
FibroBiologics,
Inc.
Amendment
No. 2 to Draft Registration Statement on Form S-1
Submitted
October 13, 2023
CIK
No. 0001958777
Ladies
and Gentlemen:
This
letter is submitted on behalf of FibroBiologics, Inc. (the “Company”) in response to comments of the staff
(the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with
respect to the Company’s Amendment No. 2 to Draft Registration Statement on Form S-1 confidentially submitted on October 13, 2023
(the “Draft Registration Statement”), as set forth in the Staff’s letter dated October 27, 2023 (the
“Comment Letter”).
Set
forth below are the Company’s responses to the Staff’s comments in the Comment Letter. For reference purposes, the text of
the Staff’s comments are reproduced in bold below, followed by the Company’s response to the comment. The numbered paragraphs
below correspond to the numbered comments in the Comment Letter.
Additionally,
the Company is concurrently submitting a Registration Statement on Form S-1 (the “Registration Statement”),
which reflects revisions in response to the Comment Letter and certain other updates. For the convenience of the Staff, we are also sending,
by overnight courier, copies of this letter and copies of the Registration Statement, marked to show changes to the Draft Registration
Statement as originally confidentially submitted.
Cover
Page
1.
We
note your revised disclosure that upon the Direct Listing you will have 2,500 shares of Series
C Preferred Stock with super-voting rights. Please advise whether you will be a controlled
company under the Nasdaq rules. If so, please include appropriate disclosure on the prospectus
cover page, in the Prospectus Summary, provide risk factor disclosure of this status and
disclose the corporate governance exemptions available to a controlled company. To the extent
you will be a controlled company, the cover page and Prospectus Summary disclosure should
include the identity of your controlling stockholder, the amount of voting power the controlling
stockholder will own following the completion of the offering and whether you intend to rely
on any exemptions from the corporate governance requirements that are available to controlled
companies.
Company
Response: We will be a “controlled company” within the meaning of the listing rules of The Nasdaq Stock Market LLC after
the Direct Listing. In response to the Staff’s comment, the Company has included the requested controlled company disclosure in
the Registration Statement.
Sale
Price History of Our Capital Stock, page 121
2.
Please
revise your disclosure on page 121 to further clarify what is meant by a “loyalty,
early-bird timing, amount based, and/or StartEngine owners bonus requirements”
and tell us whether any of the bonus shares were issued for purposes of meeting the Nasdaq
listing requirements and standards for the Direct Listing.
Company
Response: In response to the Staff’s comment, the Company has revised the referenced disclosure to further clarify what is
meant by a “loyalty, early-bird timing, amount based, and/or StartEngine owners bonus requirements.” None of the bonus hares
were issued for the purpose of meeting the Nasdaq listing requirements and standards for the Direct Listing.
General
3.
Please
tell us the specific NASDAQ listing requirements and standards that you intend to rely
on in order to list your shares on the Nasdaq Global Market and how you intend to meet those
requirements and standards.
Company
Response: The Company intends to rely on the Market Value Standard of the Nasdaq Global Market: Direct Listing Financial and Liquidity
Requirements, which include the following requirements that we intend to meet or exceed at the time of our Direct Listing:
● Valuation
based Market Value of Listed Securities $150 million;
● Unrestricted
Publicly Held Shares: 1.1 million;
● Valuation
based Market Value of Unrestricted Publicly Held Shares of $40 million;
● Valuation
based Bid Price $8;
● Unrestricted
Round Lot Shareholders: 400; and
● Market
Makers: 4.
Remainder
of page intentionally blank. Signature page follows.
Should
the Staff have additional questions or comments regarding this submission, please do not hesitate to contact the undersigned at (713)
651-5557 or brian.fenske@nortonrosefulbright.com.
Sincerely,
NORTON
ROSE FULBRIGHT US LLP
/s/
Brian P. Fenske
Brian
P. Fenske
Enclosure
cc:
Pete
O’Heeron, Chief Executive Officer
Mark
Andersen, Chief Financial Officer
FibroBiologics,
Inc.
2023-10-27 - UPLOAD - FibroBiologics, Inc. File: 377-06725
United States securities and exchange commission logo
October 27, 2023
Pete O’Heeron
Chief Executive Officer
FibroBiologics Inc.
455 E. Medical Center Blvd.
Suite 300
Houston, TX 77598
Re:FibroBiologics Inc.
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted October 13, 2023
CIK No. 0001958777
Dear Pete O’Heeron:
We have reviewed your amended draft registration statement and have the following
comments.
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 a comment applies to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to this letter 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 October 13, 2023
Cover Page
1.We note your revised disclosure that upon the Direct Listing you will have 2,500 shares of
Series C Preferred Stock with super-voting rights. Please advise whether you will be a
controlled company under the Nasdaq rules. If so, please include appropriate disclosure on
the prospectus cover page, in the Prospectus Summary, provide risk factor disclosure of
this status and disclose the corporate governance exemptions available to a controlled
company. To the extent you will be a controlled company, the cover page and Prospectus
Summary disclosure should include the identity of your controlling stockholder, the
amount of voting power the controlling stockholder will own following the completion of
the offering and whether you intend to rely on any exemptions from the corporate
governance requirements that are available to controlled companies.
FirstName LastNamePete O’Heeron
Comapany NameFibroBiologics Inc.
October 27, 2023 Page 2
FirstName LastName
Pete O’Heeron
FibroBiologics Inc.
October 27, 2023
Page 2
Sale Price History of Our Capital Stock, page 121
2.Please revise your disclosure on page 121 to further clarify what is meant by a "loyalty,
early-bird timing, amount based, and/or StartEngine owners bonus requirements" and tell
us whether any of the bonus shares were issued for purposes of meeting the Nasdaq listing
requirements and standards for the Direct Listing.
General
3.Please tell us the specific NASDAQ listing requirements and standards that you intend to
rely on in order to list your shares on the Nasdaq Global Market and how you intend to
meet those requirements and standards.
Please contact Tracie Mariner at 202-551-3744 or Angela Connell at 202-551-3426 if you
have questions regarding comments on the financial statements and related matters. Please
contact Cindy Polynice at 202-551-8707 or Tim Buchmiller at 202-551-3635 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Kelvin Kesse, Esq.
2023-09-11 - UPLOAD - FibroBiologics, Inc. File: 377-06725
United States securities and exchange commission logo
September 11, 2023
Pete O’Heeron
Chief Executive Officer
FibroBiologics Inc.
455 E. Medical Center Blvd.
Suite 300
Houston, TX 77598
Re:FibroBiologics Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted August 16, 2023
CIK No. 0001958777
Dear Pete O’Heeron:
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 August 16, 2023
Cover Page
1.Please revise the second paragraph to disclose whether the Series B and B-1 automatically
convert to common shares on a 1:1 basis or at a different conversion rate.
Our Current Pipeline, page 3
2.We note your response to prior comment 6. Please clarify development status in the
pipeline table by aligning each column header with a respective column. In this regard, we
note that it is unclear whether the current table depicts you as having completed Phase 1
trials for CybroCell or whether it depicts you as only having completed Preclinical work.
FirstName LastNamePete O’Heeron
Comapany NameFibroBiologics Inc.
September 11, 2023 Page 2
FirstName LastName
Pete O’Heeron
FibroBiologics Inc.
September 11, 2023
Page 2
Management's Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Estimates
Stock-Based Compensation, page 76
3.We have read your response to prior comment 26. Please expand your disclosure to state
that the estimates used to determine stock-based compensation expense will not be
necessary to determine the fair value of new awards once the underlying shares begin
trading.
Our Solution, page 82
4.We note your revised disclosure in response to prior comment 12. Please revise to
identify the safety and efficacy endpoints for the planned Phase 1/2 trial for CybroCell. If
the endpoints have not been established then please revise to disclose this point and
discuss the steps that you will need to conduct in order to establish the endpoints.
Principal and Registered Stockholders, page 114
5.Please revise the disclosure on page 114 to explain how many of the common shares
outstanding are attributable to the automatic conversion of each of the following: (i) the
Series B Preferred, (ii) the non-voting common and (iii) the Series A Preferred. Also, tell
us whether SpinalCyte LLC/FibroGenesis is a principal and/or Registered Stockholder.
Financial Statements
Note 7- Share Purchase Agreement, page F-11
6.We have read your response to prior comment 25 as it pertains to your share purchase
agreement. You state that the purchase agreement represents a derivative but that the fair
value prior to public listing is $0. You also indicated that the commitment fee represents a
payment to the purchaser rather than an issuance cost and will be recorded as a reduction
to additional paid-in capital when it becomes probable upon a public listing. Further, we
note your disclosure, under this heading, that the commitment fee of 2% of the aggregate
limit is due no later than one year after a public listing even if no drawdowns are taken.
Given your current offering, please tell us how you considered the probability of a public
listing in estimating the fair value of your derivative and related commitment fee as of
December 31, 2022 and June 30, 2023. In addition, please explain your consideration of
filing the share purchase agreement as an exhibit to your next amendment.
FirstName LastNamePete O’Heeron
Comapany NameFibroBiologics Inc.
September 11, 2023 Page 3
FirstName LastName
Pete O’Heeron
FibroBiologics Inc.
September 11, 2023
Page 3
You may contact Angela Connell at 22-551-3426 or Tracie Mariner at 202-551-3744 if
you have questions regarding comments on the financial statements and related matters. Please
contact Cindy Polynice at 202-551-8707 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Kelvin Kesse, Esq.
2023-06-23 - UPLOAD - FibroBiologics, Inc. File: 377-06725
United States securities and exchange commission logo
June 23, 2023
Pete O’Heeron
Chief Executive Officer
FibroBiologics Inc.
455 E. Medical Center Blvd.
Suite 300
Houston, TX 77598
Re:FibroBiologics Inc.
Draft Registration Statement on Form S-1
Submitted May 18, 2023
CIK No. 0001958777
Dear Pete O’Heeron:
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 May 18, 2023
Cover Page
1.Please disclose on your cover page whether your listing is contingent on the final approval
of NASDAQ.
Prospectus Summary, page 2
2.Please balance the Summary discussion of the opportunity you see in your market, your
value proposition and your growth strategy with equally prominent disclosure of the
challenges you face and the risks and limitations that could harm your business or inhibit
your strategic plans regarding development of fibroblast therapy products. For instance,
FirstName LastNamePete O’Heeron
Comapany NameFibroBiologics Inc.
June 23, 2023 Page 2
FirstName LastNamePete O’Heeron
FibroBiologics Inc.
June 23, 2023
Page 2
we note your risk factor disclosure on page 24 indicating that to date no fibroblast therapy
products have been approved and that only a small number of clinical trials involving
fibroblasts have been conducted.
Our Current Pipeline, page 3
3.We note your disclosure stating that you have completed a Phase 1 study of your drug
candidate, CYMS01. However, your pipeline chart on pages 3 and 78 appears to show
that this drug candidate is in still in the preclinical stage. Please advise.
4.Please revise the pipeline table to remove the CYW628, TBC190 and CYTER915
candidates from the table. In this regard, your disclosures indicate that your work on these
candidates is early-stage and, as such, these candidates should not be highlighted in the
Summary pipeline table.
5.We note your disclosure on page 3 highlighting your belief that CybroCell will prove
superior to existing treatments because you expect it will be less invasive, and will
regenerate the disc, restore function and reduce pain without debilitating long-term
effects. Given that you have not conducted human clinical trials, please revise to provide
balance and context to your beliefs and expectations regarding the potential performance
of the product under development.
Pipeline Table, page 3
6.Please revise your pipeline table to make the columns for each phase the same size.
Risk Factors, page 9
7.Please revise your risk factor on page 61 regarding exclusive forum jurisdiction to include
discussion of Section 27 of the Exchange Act, which grants exclusive federal jurisdiction,
and Section 22 of the Securities Act, which grants concurrent jurisdiction for federal and
state courts.
Results of Operations
Comparison of Fiscal Years December 31, 2022 and 2021
Research and Development Expenses, page 70
8.Please expand your disclosure of research and development expenses to provide a
breakout of expenses by product candidate. To the extent that you do not track expenses
by product candidate, please so state.
Business, page 76
9.We note your disclosure on page 12 indicating that your existing capital will enable you to
fund operations through at least June 30, 2024. Please revise the Business section, where
appropriate, to discuss your plans to fund development work for each product candidate.
Quantify the funds that you plan to allocate to each candidate(s) and discuss whether such
FirstName LastNamePete O’Heeron
Comapany NameFibroBiologics Inc.
June 23, 2023 Page 3
FirstName LastNamePete O’Heeron
FibroBiologics Inc.
June 23, 2023
Page 3
allocation is planned to reach a specific stage in the development process (e.g., through
phase 1, phase 2, etc.).
Fibroblasts Technology Platform, page 76
10.Please revise your disclosure at the top of page 77 to identify and discuss the studies that
have "demonstrated that allogeneic fibroblasts, much like mesenchymal stem cells, are
immune-privileged and do not provoke an immune response in vitro and in vivo."
CybroCell for Degenerative Disc Disease, page 79
11.Please revise to include narrative disclosure explaining the illustrative diagram depicted
on page 79 so it is clear how this diagram support the claims made in this section.
Our Solution, page 81
12.Please revise to disclose when you received IND clearance for the Phase 1/2 trial. Explain
the trial design, including the number of participants and the clinical endpoints. Clarify
whether the drug will be injected into the degenerating disc, which we note was the
method of administration in the rabbit studies that you reference. Discuss the work
involved in submitting and gaining approval for a master cell bank, including
whether material costs are required for that process.
13.Please revise to present the data from each of the animal studies. From the discussion, it
should clear how many animals were tested and whether the data is statistically
significant. Revise the Summary on page 3 to explain briefly how the results were
"positive."
14.Please revise to present Dr. An's consent for the summarization attributed to him on page
82. Refer to Rule 436.
Our Solution, page 83
15.Please revise to explain briefly the four efficacy-related tests used in the trial. Present the
data for each of the five participants.
16.Please revise to explain why you are conducting further research into the mode of action
prior to filing the Phase 2 IND application. Clarify whether the IND filing is planned for
the US or Mexico.
Intellectual Property, page 86
17.Please revise to specify how many granted patents are covered by the license agreements
and clarify the applicable jurisdictions for these patents. Clarify whether you have
composition of matter patents covering your lead candidates.
18.We note that you have issued Series A Preferred Stock to Fibrogenesis in exchange for a
FirstName LastNamePete O’Heeron
Comapany NameFibroBiologics Inc.
June 23, 2023 Page 4
FirstName LastNamePete O’Heeron
FibroBiologics Inc.
June 23, 2023
Page 4
patent assignment agreement. Please revise your disclosure here to clarify how much
preferred stock was provided in exchange for the patent assignment agreement.
Management
Executive Officers, page 99
19.Please revise your disclosure in this section to include the dates for current and prior
positions held by Pete O'Heeron and Dr. Hamid Khoja.
Principal and Registered Stockholders, page 112
20.Please revise your registration statement to clearly state that shareholders or registered
holders may elect to sell their shares in connection with this listing and in market
transactions following the listing. Please also include the number of shares held by the
registered holders and the portion of those shares that may be freely sold upon
effectiveness of the registration statement, as well as the number of shares that may be
freely sold in reliance on an exemption from registration such as Rule 144.
21.Please revise to identify the natural person(s) who have voting and/or dispositive control
of the shares beneficially owned by Golden Knight Incorporated.
Sale Price History of Our Capital Stock, page 118
22.Please revise this section to explain why the bonus shares were paid in each instance.
Plan of Distribution, page 123
23.With reference to your disclosure on page 124, please revise to discuss NASDAQ direct
listing rules as they relate to the Advisor's ability to affirmatively direct/request NASDAQ
to delay the opening cross until the Advisor feels there is sufficient trading volume.
Financial Statements, page F-1
24.Please explain to us your basis for presenting carve-out financial statements for the years
ended December 31, 2022 and 2021. Specifically address the following in your response:
•You disclose that you were formed on April 8, 2021 through the issuance of
35,000,000 shares of Series A Preferred Stock to your former parent, FibroGenesis,
in return for rights to certain intellectual property. As such, it is unclear why you
have not presented stand-alone financial statements for FibroBiologics from April 8,
2021 (inception) through December 31, 2021 and for the year ended December 31,
2022. Please advise.
•It is unclear why you would present financial statements on a carve-out basis for
FibroBiologics after the date of its formation when it became a separate stand-alone
legal entity. In this regard, you disclose that "prior to its formation" the Company
operated as a line of business of FibroGenesis and that your expenses included certain
allocations from the parent for the company's portion of general and administrative
and research and development expenses originally incurred by the parent "prior to the
FirstName LastNamePete O’Heeron
Comapany NameFibroBiologics Inc.
June 23, 2023 Page 5
FirstName LastName
Pete O’Heeron
FibroBiologics Inc.
June 23, 2023
Page 5
Company's formation on April 8, 2021". You further disclose in MD&A that since
inception your operations have included business planning, hiring personnel, raising
capital, building your intellectual property portfolio and performing research and
development on your product candidates and our fibroblast technology. It is therefore
unclear why carve-out financial statements would be appropriate for the period from
April 8, 2021 (inception) through December 31, 2021 and for the year ended
December 31, 2022.
•Please ensure that all agreements related to your company formation, including the
Patent Assignment Agreement and the Intellectual Property Cross-License
Agreement, are filed as we may review them as part of our analysis.
Note 7- Share Subscription Agreement, page F-11
25.We note your disclosure stating that, on November 12, 2021, you entered into a Share
Purchase Agreement with certain investors for the sale of up to $100,000 thousand of
common stock, which is contingent upon you achieving a public listing of your common
stock. Please tell us how you accounted for this agreement and the accounting literature
you relied upon in your determination.
Note 11- Share-based Compensation, page F-14
26.Given the significance of your stock-based compensation expense to your financial
statements, please tell us how you considered the guidance in Item 303(b)(3) of
Regulation S-K in determining not to include it as a critical accounting estimate in your
Management's Discussion and Analysis of Financial Condition and Results of Operations.
27.Once you have an estimated offering price or range, please explain to us how you
determined the fair value of the common stock underlying your equity issuances and the
reasons for any differences between the recent valuations of your common stock leading
up to the IPO and the estimated offering price. This information will help facilitate our
review of your accounting for equity issuances. Please discuss with the staff how to
submit your response.
You may contact Tracie Mariner at (202) 551-3744 or Angela Connell at (202) 551-3426
if you have questions regarding comments on the financial statements and related
matters. Please contact Cindy Polynice at (202) 551-8707 or Joe McCann at (202) 551-6262
with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Kelvin Kesse, Esq.