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September 12, 2019
Antony Koblish
President and Chief Executive Officer
TELA Bio, Inc.
1 Great Valley Parkway, Suite 24
Malvern, Pennsylvania 19355
Re: TELA Bio, Inc.
Draft Registration Statement on Form S-1
Submitted August 16, 2019
CIK No. 0001561921
Dear Mr. Koblish:
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 August 16, 2019
Prospectus Summary, page 1
1. Please tell us whether you commissioned any of the third-party data
included in your
registration statement.
2. Please revise your disclosure on pages 1-9 to avoid repetition of the
detail that you include
later in your prospectus. For example, we note that much of the
disclosure in the tables
and footnote on page 6 appear on page 104 in your prospectus.
3. In each instance where you mention how your products received clearance
from the FDA,
please revise to clarify what entity actually obtained and holds those
clearances.
Antony Koblish
FirstName LastNameAntony Koblish
TELA Bio, Inc.
Comapany 12, 2019
September NameTELA Bio, Inc.
September 12, 2019 Page 2
Page 2
FirstName LastName
Implications of Being an Emerging Growth Company, page 8
4. 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.
We are highly dependent upon Aroa, page 22
5. Please clarify the significance of Aroa holding the FDA clearances
under which you
commercialize your products, including any material risks that
presents to your business,
including under its license to you. In this regard, if you have an
exclusive license from
Aroa to develop your product, it is unclear why Aroa holds FDA
clearances related to
your product and why you then only market those products. Please
revise to explain.
Our fourth amended and restated certificate of incorporation, page 56
6. We note that your forum selection provision identifies the Court of
Chancery of the State
of Delaware as the exclusive forum for certain litigation, including
any "derivative
action." Please disclose whether this provision applies to actions
arising under the
Securities Act or Exchange Act. In that regard, we note that Section
27 of the Exchange
Act creates exclusive federal jurisdiction over all suits brought to
enforce any duty or
liability created by the Exchange Act or the rules and regulations
thereunder, and Section
22 of the Securities Act creates concurrent jurisdiction for federal
and state courts over all
suits brought to enforce any duty or liability created by the
Securities Act or the rules and
regulations thereunder. If the provision applies to Securities Act
claims, please also revise
your prospectus to state that there is uncertainty as to whether a
court would enforce such
provision and that investors cannot waive compliance with the federal
securities laws and
the rules and regulations thereunder. If this provision does not apply
to actions arising
under the Securities Act or Exchange Act, please also ensure that the
exclusive forum
provision in the governing documents states this clearly, or tell us
how you will inform
investors in future filings that the provision does not apply to any
actions arising under the
Securities Act or Exchange Act.
Use of Proceeds, page 60
7. Please revise to quantify the amount of proceeds to be allocated to
each purpose cited in
the third paragraph on page 60. Also revise to clarify whether the
amounts you intend to
devote to each purpose will be sufficient to accomplish the purposes
that you intend to
achieve.
Dilution, page 65
8. Please disclose how the amounts and percentages in the table on page
66 would change
assuming the exercise of all outstanding options and warrants
mentioned on page 67.
Antony Koblish
FirstName LastNameAntony Koblish
TELA Bio, Inc.
Comapany 12, 2019
September NameTELA Bio, Inc.
September 12, 2019 Page 3
Page 3
FirstName LastName
Management's Discussion and Analysis, page 71
9. We note the disclosure regarding clinical results relating to the
"first 32 patients who
reached one year follow-up." Please revise to clarify whether there
were patients who
reached one year follow-up after the first 32 that did not achieve the
same or similar
clinical results to the first 32. Also disclose whether there were any
recurrences in
subsequent follow-up periods.
Cost of Revenue, page 75
10. Please disclose why anticipated demand "has been slower to materialize
than
anticipated." Also disclose whether that trend has continued and its
impact on your
business.
Contractual Obligations and Commitments, page 81
11. Please tell us the dollar amount of the contracts excluded from the
table based on the
criteria mentioned in footnote (3) on page 81.
Estimating the Fair Value of Common Stock, page 84
12. We note that the weighted average exercise price of options issued
during 2019 is
significantly less than the $1.16 per share price of Series B
redeemable convertible
preferred stock issued during 2019. Please describe to us the reasons
for the differences
between the estimated fair value of your common stock and the Series B
redeemable
convertible preferred stock. Describe also the material positive and
negative events
occurring during 2019 which contributed to the variances in the
estimated fair value of
your common stock underlying your option issuances. Progressively
bridge to the current
estimated IPO price the fair value per share determination used for
each option grant since
January 1, 2019. We will delay our assessment of your response pending
inclusion of the
estimated IPO price in the filing.
Other Clinical Studies Using our OviTex Products, page 108
13. Please tell us about any relationships you had with the studies,
including whether you
commissioned the studies or otherwise participated in them.
14. With a view toward balanced disclosure as to what your products have
shown in studies
referenced in this and other sections of your disclosure, tell us
whether the studies have
revealed any material disadvantages.
Executive Officers, page 127
15. It appears Mr. Koblish is currently employed by or otherwise provides
services for other
entities. If so, clarify the amount of time he devotes to your
affairs. Please also clarify
Ms. Brennan's business experience from April 2018 until January 2019.
Antony Koblish
TELA Bio, Inc.
September 12, 2019
Page 4
Narrative Disclosure to Summary Compensation Table, page 134
16. Please revise to clarify the reasons for the 12% merit increase to Dr.
Greenhalgh's salary.
Also revise to clarify the "corporate and/or individual performance
goals" referenced on
page 135 and how the achievement of those goals relates to the amount of
annual bonuses
paid.
Principal Stockholders, page 147
17. Please disclose the natural person or persons who exercise the sole or
shared voting and/or
dispositive powers with respect to the shares held by the entities
mentioned in the table on
page 148.
You may contact Tara Harkins at 202-551-3639 or Lynn Dicker, Senior
Accountant, at
202-551-3616 if you have questions regarding comments on the financial
statements and related
matters. Please contact Thomas Jones at 202-551-3602 or Geoff Kruczek, Special
Counsel, at
202-551-3641 with any other questions.
Sincerely,
FirstName LastNameAntony Koblish
Division of
Corporation Finance
Comapany NameTELA Bio, Inc.
Office of
Electronics and Machinery
September 12, 2019 Page 4
cc: Rachael M. Bushey
FirstName LastName