United States securities and exchange commission logo
September 17, 2020
Rogerio Vivaldi Coelho, M.D.
Chief Executive Officer
Sigilon Therapeutics, Inc.
100 Binney Street, Suite 600
Cambridge, MA 02142
Re: Sigilon
Therapeutics, Inc.
Draft Registration
Statement on Form S-1
Submitted August
21, 2020
CIK No. 0001821323
Dear Dr. Vivaldi Coelho:
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
Overview, page 1
1. Please revise to
furnish the date on which you received approval of your IND submission
for SIG-001 in
Hemophilia A.
2. Please define all terms
of art, such as "allogenic" and "lysosomal storage diseases" on first
use.
3. Please revise the
pipeline table on pages 3 and 112 to add separate columns for each of
Phase 1, Phase 2 and
Phase 3 testing, and refrain from using "pivotal" because of the
term's ambiguity.
Please also expand the table and your disclosure to provide more
information about the
current status of your pre-clinical treatments. If you have
Rogerio Vivaldi Coelho, M.D.
FirstName LastNameRogerio Vivaldi Coelho, M.D.
Sigilon Therapeutics, Inc.
Comapany 17,
September NameSigilon
2020 Therapeutics, Inc.
September
Page 2 17, 2020 Page 2
FirstName LastName
undertaken IND enabling studies for any of the treatments listed in
the table, please
describe these studies greater detail in the disclosure. Finally,
please revise the table to
more clearly show that to date only one product has received IND
approval.
4. Please remove the green stars from the piepline table on pages 3 and
112. In lieu of the
green stars, please add narrative disclosure that explains the basis
for your belief that you
may receive IND approval within 24 months. Please disclose in greater
detail where the
products are in the process, what steps you have taken towards
submitting an IND
application, what risks of non-completion remain, and why you believe
that 24 months is
the appropriate time frame.
5. Regarding the pipeline table on pages 3 and 112, please tell us why
you believe it is
material to investors to include in the table the SIG-014, SIG-015 and
SIG-018 programs.
In this regard, we note based on the limited disclosure about these
programs elsewhere in
the prospectus that they appear to be in only a very early stage of
development.
Alternatively, please remove these programs from the table.
6. On page 5, please balance your disclosure that the company has raised
"nearly $200
million" by also mentioning the company's current deficit. In this
regard, we note your
Capitalization disclosure on page 81. Alternatively, change the
caption to highlight
investments in the company rather than capitalization.
Risk Factors, page 12
7. We note that there are references to foreign regulators and foreign
markets throughout the
Risk Factors and other sections of your prospectus. We see that your
IND submission for
SIG-001 for Hemophilia A has been accepted in the United States and
your CTA has been
accepted in the United Kingdom, but we do not see other references to
applications to
foreign regulators. Please revise to explain what non-US markets, if
any, you plan to
enter, and what steps you have taken to attain the necessary
regulatory and patent
approvals. Tailor the risk factors section to more closely reflect the
applications you have
made or are planning to make in the near term.
Use of Proceeds, page 79
8. We note the use of proceeds to fund the clinical development of
additional indications for
your lead candidates SIG-001 and SIG-005l. Please revise to specify
how far the proceeds
of the offering will take the company into the clinical development of
these candidates. If
any material amounts of other funds are necessary to accomplish the
specified purposes
for which the proceeds are to be obtained, state the amounts and
sources of such other
funds needed for each such specified purpose and the sources thereof.
Refer to Instruction
3 of Item 504 of Regulation S-K.
Rogerio Vivaldi Coelho, M.D.
FirstName LastNameRogerio Vivaldi Coelho, M.D.
Sigilon Therapeutics, Inc.
Comapany 17,
September NameSigilon
2020 Therapeutics, Inc.
September
Page 3 17, 2020 Page 3
FirstName LastName
Critical Accounting Policies and Significant Judgments and Estimates
Stock-Based Compensation, page 107
9. 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 including stock
compensation and
beneficial conversion features.
Eli Lilly Strategic Research and Development Partnership, page 147
10. Regarding the sales-based royalties payable under the agreement,
please narrow your
disclosure about the royalty range in the second paragraph on page 148
so that the span of
the range is no more than 10% for each tier.
Financial Statements
Note 6. Debt, page F-25
11. We note your disclosure that in June 2020, you obtained a debt
covenant waiver relating
to the filing of audited financial statements within 180 days of
year-end. Please clearly
disclose whether you are in compliance with all other debt covenants.
Part II
Item 16. Exhibits and Financial Statement Schedules., page II-3
12. Please file as an exhibit to the registration statement your loan and
security agreement
with Pacific Western Bank, as amended to date, or tell us why you
believe it is not a
material agreement.
General
13. Please supplementally provide us with copies of all written
communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to
do so on your behalf,
present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
not they retain copies of the communications. Please contact Julia
Griffith at 202-551-
3267 to discuss how to submit the materials, if any, to us for our
review.
14. Please provide us mockups of any pages that include any additional
pictures or graphics to
be presented, including any accompanying captions. Please keep in
mind, in scheduling
your printing and distribution of the preliminary prospectus, that we
may have comments
after our review of these materials.
Rogerio Vivaldi Coelho, M.D.
Sigilon Therapeutics, Inc.
September 17, 2020
Page 4
You may contact Nudrat Salik at 202-551-3692 or Angela Connell at
202-551-3426 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Julia Griffith at 202-551-3267 or Dietrich King at 202-551-8071 with
any other
questions.
FirstName LastNameRogerio Vivaldi Coelho, M.D. Sincerely,
Comapany NameSigilon Therapeutics, Inc.
Division of
Corporation Finance
September 17, 2020 Page 4 Office of Life
Sciences
FirstName LastName