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United States securities and exchange commission logo
July 16, 2020
Jean-Pierre Sommadossi, Ph.D.
President and Chief Executive Officer
Atea Pharmaceuticals, Inc.
125 Summer Street
Boston, MA 02110
Re: Atea
Pharmaceuticals, Inc.
Draft Registration
Statement on Form S-1
Submitted June 19,
2020
CIK No. 0001593899
Dear Dr. Sommadossi:
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 June 19, 2020
Prospectus Summary
Overview, page 1
1. We note your use of
"best-in-class" on pages 1, 96, and 107. This term suggests that your
product candidates are
effective, likely to be approved and compare favorably to
competitive products.
Please delete these references throughout your registration
statement. If your use
of this term was intended to convey your belief that the products
are based on a novel
technology or approach, you may discuss how your technology
differs from technology
used by competitors. Statements such as these should be
accompanied by
cautionary language that the statements are not intended to give any
Jean-Pierre Sommadossi, Ph.D.
FirstName LastNameJean-Pierre Sommadossi, Ph.D.
Atea Pharmaceuticals, Inc.
Comapany
July NameAtea Pharmaceuticals, Inc.
16, 2020
July 16,
Page 2 2020 Page 2
FirstName LastName
indication that the product candidates have been proven effective or
that they will receive
regulatory approval.
2. We note your description of AT-527 as "potent" and "selective"
throughout the
registration statement. Given that you have relied on data obtained in
your HCV clinical
trials to initiate Phase 2 and the only data you present as to potency
and selectivity against
SARS coronaviruses are from in vitro assays that "suggest" AT-527 may
be potent and
selective, please tell us the basis for these claims.
Our product candidates, page 3
3. Please revise to indicate, if true, that AT-527 was initially
developed for the treatment of
HCV and that you initiated your clinical development program of AT-527
for the
treatment of patients with COVID-19 with a Phase 2 trial by utilizing
pharmacokinetics,
safety and tolerability data obtained from your HCV clinical trials.
Please also disclose
the current size of the clinical trial population for AT-527.
4. We note that upon the resolution of industry wide clinical challenges
associated with
COVID-19, you expect to initiate your Phase 1/2A clinical trial with
AT-787 for the
treatment of HCV. We also note your disclosure on page 125 that you
have temporarily
paused your development, given your prioritization of resources
towards the development
of AT-527 for COVID-19, as well as industry wide challenges in
clinical studies during
the COVID-19 pandemic. To the extent that you have paused any of your
programs to
prioritize your resources towards AT-527, please revise the summary to
make this clear.
Implications of Being an Emerging Growth Company, page 5
5. Please 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.
A number of companies and universities file and obtain patents..., page 61
6. We note that you may not be aware of patent claims that are currently
or may in the future
be pending that affect your business. With a view toward clarifying
that disclosure, if you
are aware or have experienced any challenges or infringements to your
rights, please so
disclose.
Use of Proceeds, page 86
7. With reference to your product pipeline table on page 1 and your R&D
expense table on
page 97, please revise paragraph three to provide an estimate
regarding how far in the
development process for AT-527, AT-787, and AT-752 the allocated
proceeds of the
offering will enable you to reach. Also, please disclose the total
estimated cost of each of
the specified purposes for which the net proceeds are intended to be
used, and, if material
Jean-Pierre Sommadossi, Ph.D.
Atea Pharmaceuticals, Inc.
July 16, 2020
Page 3
amounts of other funds are necessary to accomplish the specified
purposes, provide an
estimate of the amounts of such other funds and the sources thereof.
Refer to Instruction 3
of Item 504 of Regulation S-K.
Business
Overview, page 107
8. We note your disclosure that your approach allows you to maximize the
formation of an
active metabolite, potentially resulting in "highly potent" product
candidates. Please
clarify what you mean by the term highly potent and explain the risks
to your strategy if
your candidates do not prove to be highly potent.
Viral resistance and mutations, page 112
9. We note your disclosure on page 117 that the RNA-dependent RNA
polymerase in SARS-
CoV-1 contains a proofreading exonuclease (nsp14) and understand that
SARS-CoV-2
contains a similar proofreading exonuclease. Please explain if the
presence of an
exonuclease in the RdRP could impair the potency of your product
candidate for SARS-
Co-V-2 or if mutations in that enzyme could have similar effects.
10. We note you use a prodrug. If the phosphorylating enzymes in the
targeted cells could
mutate in a way that could inhibit the formation of active metabolites
of the prodrug,
please revise your disclosure to address that as a challenge to your
treatment strategy.
11. We note from your product candidate pipeline that you intend to use
single drug therapies
to treat COVID-19, Dengue and RSV. Given the obstacles of viral
resistance and
mutations that you describe, to the extent you intend to use
monotherapies for the
disclosed indications, please disclose the risks presented by your
strategy as compared to
combination or cocktail drug strategies and include risk factor
disclosure as appropriate.
Our approach, page 117
12. We note your disclosure relating to the in vitro assays and that the
concentration of AT-
511 required to exhibit CC50 of the host cells used in these assays to
support viral
infections and propagation was consistently greater than the highest
concentration tested
(>100 uM), suggesting high potency and selectivity. Please revise to
clarify why this
suggests high potency and selectivity.
Phase 2 clinical trial, page 119
FirstName LastNameJean-Pierre Sommadossi, Ph.D.
13. We note that you are enrolling patients aged 45 to 80 years with
moderate COVID-19
Comapany NameAtea
illness. Pharmaceuticals,
To the extent Inc. revise to disclose whether the
age range for the
material, please
July 16,prior
2020HCVPageclinical
3 trials were the same.
FirstName LastName
Jean-Pierre Sommadossi, Ph.D.
FirstName LastNameJean-Pierre Sommadossi, Ph.D.
Atea Pharmaceuticals, Inc.
Comapany
July NameAtea Pharmaceuticals, Inc.
16, 2020
July 16,
Page 4 2020 Page 4
FirstName LastName
AT-787 for the treatment of hepatitis C, page 120
14. Please revise your reference to AT-787 s "improved safety profile"
on page 122 to remove
your conclusion regarding the safety of your product candidate as this
determination is
solely within the authority of the FDA and comparable regulatory
bodies.
Executive and Director Compensation
Executive Compensation Arrangements, page 154
15. We note that neither Dr. Sommadossi nor Ms. Corcoran is currently a
party to an
agreement that provides for severance, termination or change in
control benefits. Please
clarify and disclose whether you have any material employment
agreements covering any
other aspect of employment. If so, please file any such agreements as
exhibits to your
registration statement.
Principal Stockholders, page 166
16. Please include footnotes to your table that disclose the natural
persons who
have beneficial ownership of the shares held by the entities listed in
your table.
You may contact Gary Newberry at 202-551-3761 or Lynn Dicker at
202-551-3616 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jeffrey Gabor at 202-551-2544 or Tim Buchmiller at 202-551-3635 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Wesley C. Holmes, Esq.