<SEC-DOCUMENT>0000000000-21-003648.txt : 20210604
<SEC-HEADER>0000000000-21-003648.hdr.sgml : 20210604
<ACCEPTANCE-DATETIME>20210325173008
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000000000-21-003648
CONFORMED SUBMISSION TYPE:	UPLOAD
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20210325

FILED FOR:		

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Talaris Therapeutics, Inc.
		CENTRAL INDEX KEY:			0001827506
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		UPLOAD

	BUSINESS ADDRESS:	
		STREET 1:		201 E. JEFFERSON ST., SUITE 110B
		CITY:			LOUISVILLE
		STATE:			KY
		ZIP:			40202
		BUSINESS PHONE:		502-569-1059

	MAIL ADDRESS:	
		STREET 1:		201 E. JEFFERSON ST., SUITE 110B
		CITY:			LOUISVILLE
		STATE:			KY
		ZIP:			40202
</SEC-HEADER>
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.pdf
<TEXT>
<PDF>
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<TEXT>
United States securities and exchange commission logo





                              March 25, 2021

       Scott Requadt
       Chief Executive Officer
       Talaris Therapeutics, Inc.
       570 S. Preston St.
       Louisville, KY 40202

                                                        Re: Talaris
Therapeutics, Inc.
                                                            Draft Registration
Statement on Form S-1
                                                            Submitted February
26, 2021
                                                            CIK No. 0001827506

       Dear Mr. Requadt:

              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

       Prospectus Summary, page 1

   1.                                                   Please clarify the
meaning of scientific or technical terms the first time they are used in
                                                        order to ensure that
lay readers will understand the disclosure. For example, please briefly
                                                        explain what you mean
by chronic immunosuppression (as described on page 109), full
                                                        myeloablative
conditioning and nonmyeloablative conditioning.
   2.                                                   Please revise the
Summary to provide clear descriptions of the primary endpoints for each
                                                        of the programs
discussed, and, where applicable, whether the product candidate met such
                                                        primary endpoints.
Please also disclose any reported serious adverse events.
       Overview, page 2
 Scott Requadt
FirstName  LastNameScott
Talaris Therapeutics, Inc. Requadt
Comapany
March      NameTalaris Therapeutics, Inc.
       25, 2021
March2 25, 2021 Page 2
Page
FirstName LastName

3.       Please include disclosure of the open IND that permits you to move
directly to Phase 2 for
         the FREEDOM-2 and FREEDOM-3 trials. In addition, please confirm that
the open IND
         based on existing FCR001 safety data also applies to FREEDOM-3
patients with a severe
         form of scleroderma and who do not receive living donor kidney
transplantations.
Our Pipeline, page 3

4.       We note that the first row in your pipeline table under the heading
"Living Donor Kidney
         Transplant (LDKT)" shows a bar in the middle of Phase 3. We also note
your disclosure
         that you have initiated and are currently enrolling patients in a
Phase 3 trial of FCR001.
         Please shorten the bar in this row to show that you have recently
initiated the Phase 3 trial,
         rather than implying further progress.
5.       We refer to the fourth row of your pipeline table under the heading
"Scleroderma."
         We note the disclosure that the FREEDOM-3   s Phase 2 trial will soon
be initiated under
         the registrant   s open IND. Please disclose whether your open IND for
FRC001 applies to
         patients with a severe form of scleroderma who do not receive a living
donor kidney
         transplant or if you have filed an original IND for this program.
We face substantial competition, which may result in others discovering...,
page 21

6.       We note your disclosure that your Facilitated Allo-HSCT Therapy using
         nonmyeloablative conditioning is novel and mitigates the toxicities,
morbidities and
         extended hospital stays associated with the fully myeloablative
conditioning typically
         required by both allogeneic and autologous HSCT therapies. Please
disclose whether any
         of your competitors are developing HSCT therapy using nonmyeloablative
conditioning.
We are dependent on a limited number of suppliers, and in some cases sole
suppliers..., page 51

7.       We note your risk factor disclosure that certain of your raw materials
are available only
         from a single supplier or a limited number of suppliers. Please expand
your disclosure
         here to discuss your sources and availability of raw materials and the
names of any
         principal suppliers. See Item 101(h)(4)(v) of Regulation S-K.
Capitalization, page 82

8.       Please revise the table to exclude the amount of your cash, cash
equivalents, and
         marketable securities from your total capitalization.
Dilution, page 84

9.       Please revise your historical and pro forma net tangible book value
(deficit) to exclude
         your intangible assets.

Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Estimates
 Scott Requadt
FirstName  LastNameScott
Talaris Therapeutics, Inc. Requadt
Comapany
March      NameTalaris Therapeutics, Inc.
       25, 2021
March3 25, 2021 Page 3
Page
FirstName LastName
Determination of the Fair Value of Common Stock, page 99

10.      Please explain to us how you determined the fair value of the common
stock underlying
         your recent equity issuances and the reasons for any differences
between recent sales of
         equity and the fair value of the common stock. This information will
help facilitate our
         review of your accounting for equity issuances, including stock
compensation and
         beneficial conversion features.
Withdrawal of Chronic Immunosuppresion Irrespective of HLA Mismatch, page 120

11.      Please revise the graphics on page 121 and 135 to include labels for
both axes where
         applicable.
License Agreement with University of Louisville Research Foundation, Inc., page
139

12.      Please revise your disclosure regarding the above license agreement to
disclose the total
         amount paid to date pursuant to the agreement.
Product Interest Rights Agreement, page 186

13.      We note your disclosure surrounding the Product Interest Rights
Agreement and the units
         that have been issued to date, both here and in the notes to the
Financial Statements.
         Please clarify the total number of outstanding product interest rights
and describe how
         the formula for payment was determined. To the extent the company
believes the
         payments owed pursuant to the outstanding rights will be material in
the event of the
         commercial sale of FCR001, please so state.
Financial Statements
Note 9. Convertible Preferred Stock
Product Interest Rights, page F-17

14.      Please provide us with your analysis of the accounting for the Series
A convertible
         preferred stock, particularly the units including the product interest
rights.
Item 16. Exhibits and Financial Statement Schedules, page II-3

15.      Please revise the footnote to the exhibit index regarding the omission
of information from
         certain filed exhibits to specify the rule relied upon.
General

16.      Please provide us with supplemental 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,
         have presented or expect to present to potential investors in reliance
on Section 5(d) of the
         Securities Act, whether or not you retained, or intend to retain,
copies of those
         communications.
 Scott Requadt
Talaris Therapeutics, Inc.
March 25, 2021
Page 4

       You may contact Ibolya Ignat at 202-551-3636 or Kate Tillan at
202-551-3604 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jane Park at 202-551-7439 or Laura Crotter at 202-551-7614 with any
other questions.



                                                          Sincerely,
FirstName LastNameScott Requadt
                                                          Division of
Corporation Finance
Comapany NameTalaris Therapeutics, Inc.
                                                          Office of Life
Sciences
March 25, 2021 Page 4
cc:       Gabriela Morales-Rivera, Esq.
FirstName LastName
</TEXT>
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</SEC-DOCUMENT>
