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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