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Mail Stop 3030
January 4,
2018
Manoussos Perros, Ph.D.
Chief Executive Officer
Entasis Therapeutics Limited
35 Gatehouse Drive
Waltham, MA 02451
Re: Entasis Therapeutics Limited
Draft Registration Statement on Form S-1
Submitted December 8, 2017
CIK No. 0001724344
Dear Dr. Perros:
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.
Overview, page 1
1. We note the market data disclosed in your submission. Please revise
to clarify how such
data relates to the actual market that may be addressed by each of
your products for the
regulatory indications you intend to pursue.
Implications of the Being an Emerging Growth Company, page 8
2. 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 communication.
Manoussos Perros, Ph.D.
Entasis Therapeutics Limited
January 4, 2018
Page 2
Use of Proceeds, page 67
3. If material, indicate your estimated use of net proceeds for development
of your
zoliflodacin candidate.
Corporate Reorganization, page 70
4. The first sentence of the first paragraph states that Entasis
Therapeutics Limited will be
the issuer in this offering. Later in that paragraph, you indicate that
Entasis Therapeutics
plc will issue ordinary shares in this offering. Please revise to
clarify who will be the
issuer of ordinary shares in this offering.
5. Revise to describe briefly the purpose of the transactions referenced in
this section.
Dilution, page 73
6. Disclose how the numbers and percentages in the table on page 74 would
change,
assuming the exercise of all outstanding options.
Funding Arrangements, page 78
7. Please revise to clarify what are "qualified research expenditures"
under the disclosed
arrangements. Include in your revisions any material conditions you must
satisfy in order
to receive funds under those arrangements. We note, for example, the
"pre-specified
milestones" referenced on pages 67 and 114.
Business, page 90
8. Indicate how your products target "clinically validated mechanisms" in
order to address
antibiotic resistance. Clarify the nature of such clinical validation
including the nature of
the parties that validated the mechanisms and the basis for your belief
that those
mechanisms were validated.
9. We note from your disclosure that some of your products appear to be
genus or species
specific. Disclose if pathogen identification and resistance profiling
could be required
before your product candidates, if approved, would be used and if the
costs and timing
associated with such tests, if any, would be a competitive disadvantage
for your products
as compared to the use of existing broad-spectrum antibiotics. Include
risk factor
disclosure as appropriate.
Manoussos Perros, Ph.D.
Entasis Therapeutics Limited
January 4, 2018
Page 3
Zoliflodacin for the treatment of uncomplicated gonorrhea, page 93
10. We note your disclosure in the last sentence of the first paragraph of
this section. Clarify,
if known, the resistance rates for current treatments. Please also
clarify what you mean
by "uncomplicated gonorrhea."
Our Scientific Platform, page 94
11. Include additional disclosure so that investors can better understand
the nature of your
platform. Indicate whether the platform is protected by any intellectual
property rights
and whether AstraZeneca retained any rights to the platform, future
improvements to the
platform or product candidates developed with the platform. Clarify how
the platform
gives you a competitive advantage, if any.
Business Transfer and Subscription Agreement with AstraZeneca, page 114
12. Please disclose the cumulative net sales milestones referenced here and
the amount of the
royalties applicable to worldwide sales of zoliflodacin. Also clarify
whether worldwide
sales of zoliflodacin applies only to sales by you in the "major
markets" referenced on
page 115 or whether it also includes the low-income and middle-income
countries where
DNDi may commercialize the product.
Collaboration Agreement with DNDi, page 115
13. Please clarify how ownership of intellectual property will be determined
under this
agreement. Considering your disclosure that DNDi is funding clinical
trials, it is unclear
how you may develop intellectual property under the collaboration
agreement.
Signatures
14. Please include the signature of the registrant's authorized
representative in the United
States.
Manoussos Perros, Ph.D.
Entasis Therapeutics Limited
January 4, 2018
Page 4
You may contact Julie Sherman at (202) 551-3640 or Gary Todd, Senior
Accountant, at
(202) 551-3605 if you have questions regarding comments on the financial
statements and
related matters. Please contact Geoff Kruczek at (202) 551-3641 or Tim
Buchmiller, Senior
Attorney, at (202) 551-3635 with any other questions.
Sincerely,
/s/ Tim Buchmiller for
Amanda Ravitz
Assistant Director
Office of Electronics
and Machinery
cc: Jaime Chase, Esq.
Cooley LLP