<SEC-DOCUMENT>0000000000-23-006716.txt : 20240222
<SEC-HEADER>0000000000-23-006716.hdr.sgml : 20240222
<ACCEPTANCE-DATETIME>20230623083007
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000000000-23-006716
CONFORMED SUBMISSION TYPE:	UPLOAD
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20230623

FILED FOR:		

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			FibroBiologics, Inc.
		CENTRAL INDEX KEY:			0001958777
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		IRS NUMBER:				863329066
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		UPLOAD
		SEC FILE NUMBER:	377-06725

	BUSINESS ADDRESS:	
		STREET 1:		455 E. MEDICAL CENTER BLVD
		STREET 2:		SUITE 300
		CITY:			HOUSTON
		STATE:			TX
		ZIP:			77598
		BUSINESS PHONE:		281-671-5152

	MAIL ADDRESS:	
		STREET 1:		455 E. MEDICAL CENTER BLVD SUITE 300
		STREET 2:		SUITE 300
		CITY:			HOUSTON
		STATE:			TX
		ZIP:			77598

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	FibroBiologics Inc.
		DATE OF NAME CHANGE:	20221216
PUBLIC REFERENCE ACCESSION NUMBER:		0001493152-23-018053
</SEC-HEADER>
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.pdf
<TEXT>
<PDF>
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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,
 Pete O   Heeron
FirstName  LastNamePete O   Heeron
FibroBiologics Inc.
Comapany
June       NameFibroBiologics Inc.
     23, 2023
June 23,
Page 2 2023 Page 2
FirstName LastName
         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
 Pete O   Heeron
FirstName  LastNamePete O   Heeron
FibroBiologics Inc.
Comapany
June       NameFibroBiologics Inc.
     23, 2023
June 23,
Page 3 2023 Page 3
FirstName LastName
         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
 Pete O   Heeron
FirstName  LastNamePete O   Heeron
FibroBiologics Inc.
Comapany
June       NameFibroBiologics Inc.
     23, 2023
June 23,
Page 4 2023 Page 4
FirstName LastName
         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
 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,
FirstName LastNamePete O   Heeron
                                                           Division of
Corporation Finance
Comapany NameFibroBiologics Inc.
                                                           Office of Life
Sciences
June 23, 2023 Page 5
cc:       Kelvin Kesse, Esq.
FirstName LastName
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