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United States securities and exchange commission logo
September 24, 2020
Bobak Azamian
Chief Executive Officer
Tarsus Pharmaceuticals, Inc.
15440 Laguna Canyon Road
Irvine, CA 92618
Re: Tarsus
Pharmaceuticals, Inc.
Amendment No. 2 to
Draft Registration Statement on Form S-1
Submitted September
14, 2020
CIK No.: 0001819790
Dear Dr. Azamian:
We have reviewed your amended 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. Unless we note otherwise, our references to prior comments are
to comments in our
September 3, 2020 letter.
Amendment No. 2 to Draft Registration Statement on Form S-1, submitted
September 14, 2020
Prospectus Summary
Overview, page 1
1. We note your response
to our prior comment number 4. Please revise the "Anticipated
Future Milestones"
column for TP-04 to state that you expect to file an IND in 2021, as
you state on page 5.
Also revise the footnotes to state whether you have discussed with the
FDA your planned
approach to rely on TP-03 studies for TP-04 and provide balancing
disclosure that the FDA
may reject your intended approach, as you further explain on page
28.
Bobak Azamian
FirstName LastNameBobak
Tarsus Pharmaceuticals, Inc.Azamian
Comapany 24,
September NameTarsus
2020 Pharmaceuticals, Inc.
September
Page 2 24, 2020 Page 2
FirstName LastName
2. We note that your revised pipeline table now includes a new product
candidate, TP-05,
and you have arrows for both the Lyme disease and malaria indications
showing that
preclinical trials are completed because you intend to rely on
preclinical data for TP-03
for demodex belpharitis. A footnote to the pipeline table states that
you intend to
leverage data from [y]our TP-03 preclinical studies for Demodex
blepharitis as well as
third-party preclinical studies for Lyme disease or malaria,
respectively (and will not
conduct [y]our own preclinical studies for Lyme disease and malaria)
.. As TP-03 is
applied as an eye drop and TP-05 is meant to be orally ingested,
please revise to explain
the basis for your intended approach. Also revise your prospectus as
appropriate to
further explain your intention to rely on third party studies,
including identifying them,
explaining how your intended formulation would be different than the
ones used in such
other studies, and disclosing your rights to use such studies. Also
state whether you have
had any discussions with the FDA regarding your intended approach.
3. We note your revised disclosures in response to prior comment 6. We
also note our
statements on page 102, which appear to indicate you believe that the
market size for
blepharitis may be similar to the dry eye market size because of the
results of your ECP
Survey. If true, please balance your disclosure here to explain that
your belief that the
markets are comparable are based on your own internal research with a
small sample size.
Our Approach: TP-03, page 3
4. We note your revised disclosures in the pipeline table and elsewhere
that you intend for
your new product candidate TP-05 to target malaria. Based on your
disclosures in the
Business section, including on page 119, it appears that you intend
for the product
candidate to be administered widely in communities in an effort to
achieve herd
protection. Please revise your references to TP-05 in the Summary
section with respect to
this indication to clearly explain the intended method of use of this
product candidate, and
provide appropriate balancing disclosures regarding this approach.
Risk Factors
Risks Related to Development and Commercialization of Our Product Candidates ,
page 24
5. On page 25 you state that the FDA recommended carcinogenicity testing
for TP-03.
Please explain whether this recommended testing is already reflected
in your other
disclosures, such as with respect to your intended use of proceeds, or
your anticipated
timelines. Please also revise the disclosure to expressly state any
other FDA
recommendations concerning your product indications and studies.
Bobak Azamian
FirstName LastNameBobak
Tarsus Pharmaceuticals, Inc.Azamian
Comapany 24,
September NameTarsus
2020 Pharmaceuticals, Inc.
September
Page 3 24, 2020 Page 3
FirstName LastName
Use of Proceeds, page 72
6. We note your revised disclosures in response to prior comment 18,
including that you
expect the proceeds will fund further clinical development of TP-03,
as well as your TP-
04 and TP-05 programs. Please further revise to specify the stage of
development you
expect to achieve for your TP-03 program other than for Demodex
blepharitis, and
your TP-04 and TP-05 programs.
Business
Blepharitis Overview, page 98
7. We note your references on page 101 and elsewhere to a study conducted
by Gao.
Referring investors to sources outside your registration statement for
material information
is not sufficient to meet your disclosure obligation. If you retain
your discussion of the
study, please revise your disclosure to include all material
information in your prospectus,
such that you do not need to refer investors to external sources for
additional information.
For example, provide additional information regarding the participants
and how they were
selected.
Market Opportunity in Blepharitis, page 102
8. We note your response to our prior comment number 21. On page 102, you
state ECPs
were chosen based on a random sample of ophthalmologists and
optometrists that had
sufficient exposure to blepharitis patients to provide a
representative sample of ECPs who
have prescribed TP-03 to blepharitis patients. Please revise to
clarify whether the sample
of ECPs were limited to a specific geographical area or were selected
nation-wide, and
explain whether the selected patients were limited to patients of the
selected ECPs. Also
state the number of patients included in the survey and why you
believe the survey "was
representative of the number of Demodex patients." In addition, revise
this disclosure to
clarify how TP-03 is able to be prescribed given it is still in
clinical trials.
9. We note your response to our prior comment number 22. On page 104,
please explain how
the statement "[t]he Patient Survey did not measure overlap between
patients with
collarettes and those on prescription therapeutic for dry eye disease
reconciles with the
statement that "13% of the 1,121 patients presented with collarettes
and were also on a
prescription therapeutic for dry eye at the same time," which appears
earlier in the same
paragraph and is shown in Figure 13.
Our Additional Product Candidates, page 117
10. We note your revised disclosures in response to our prior comment
number 8. However,
on page 95, you continue to refer to the "observed efficacy in Io and
Europa" trials, and on
page 119, you state that preclinical studies performed by third
parties show "a favorable
safety profile." Please revise this statement as safety determinations
are solely within the
authority of the FDA and comparable regulatory bodies.
Bobak Azamian
Tarsus Pharmaceuticals, Inc.
September 24, 2020
Page 4
Malaria, page 119
11. We refer to your revised disclosures referring to a preclinical study
being "highly potent"
and demonstrating a mosquito death rate exceeding 99%. Please revise to
provide
additional information regarding such study, including its duration and
the number of
subjects involved.
Intellectual Property , page 121
12. We note your response to our prior comment number 27. Please revise your
disclosure on
page 121 to specify whether the composition of matter claims relate to
issued or pending
patents. We also note you state that your owned pending patent
applications relate to
composition of matter claims. Please clarify whether such composition of
matter claims
relate to your TP-03 product with respect to your lead indication.
13. Please re-insert the amount of the upfront payment to Elanco under the
Eye and Derm
Elanco Agreement on page 122 or advise.
You may contact Ameen Hamady at 202-551-3891 or Kate Tillan at
202-551-3604 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Margaret Schwartz at 202-551-7153 or Dorrie Yale at 202-551-8776 with
any other
questions.
Sincerely,
FirstName LastNameBobak Azamian
Division of
Corporation Finance
Comapany NameTarsus Pharmaceuticals, Inc.
Office of Life
Sciences
September 24, 2020 Page 4
cc: Ryan Gunderson
FirstName LastName