View:
United States securities and exchange commission logo
March 3, 2021
Florian Brand
Chief Executive Officer
ATAI Life Sciences B.V.
c/o Mindspace
Krausenstrabe 9-10
10117 Berlin, Germany
Re: ATAI Life Sciences
B.V.
Draft Registration
Statement on Form S-1
Submitted on
February 1, 2021
CIK No. 0001840904
Dear Mr. Brand:
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 February 1, 2021
Market and Industry Data, page ii
1. We note your statement
that industry publications and third-party research, surveys and
studies generally
indicate that their information has been obtained from sources believed
to be reliable,
although they do not guarantee the accuracy or completeness of such
information. These
statements appear to imply a disclaimer of responsibility for this
information in the
registration statement. Please either delete this statement or specifically
state that you are
liable for the information related to the market and industry data.
Prospectus Summary
Florian Brand
FirstName
ATAI Life LastNameFlorian Brand
Sciences B.V.
Comapany
March NameATAI Life Sciences B.V.
3, 2021
March2 3, 2021 Page 2
Page
FirstName LastName
Our Company, page 1
2. Please include an organization and ownership chart to explain the
structure of your
company and its subsidiaries, including your various ownership
percentages. Please also
include any variable interest entities. In addition, your ownership in
each of these
subsidiaries or variable interest entities should be clarified
throughout your registration
statement. For example, revise references to your subsidiaries to use
the partially/wholly
owned qualifiers.
Our Process, page 2
3. We note your disclosure in your graphic on page 2 that one of your key
selection criteria
is that your product candidates have the potential to be
first-in-class and throughout the
registration statement you make statements that your "portfolio
includes a number of
compounds that have the potential to be developed as first-in-class
therapeutics." The term
"first-in-class" suggests that your product candidates are effective
and likely to be
approved. Given the early stages of development for each of your
candidates, the term
appears speculative. Please revise to delete these references
throughout your registration
statement. We will not object to statements that you are developing
the candidates to
address an unmet need.
Our Enabling Technologies, page 3
4. We note your statement here and elsewhere in your draft offering
statement that your
digital therapeutics platform may "improve patient outcomes" and "has
the potential to
both secure stronger intellectual property, or IP, protection and
increase the probability of
success for [y]our programs." Given the current stage of your product
candidates, please
remove your statement that your digital therapeutics platform can
"improve patient
outcomes" and "increase the probability of success of [y]our
programs," or otherwise
provide your basis for this claim. In addition, please update your
disclosure to
explain how your digital therapeutics platform works as well as
clarify what makes
it novel or unique when compared to existing technology.
Our Pipeline, page 3
5. With respect to the "Total Programs and Enabling Technologies Per Year
Since
Inception" chart, we note it indicates you currently have 13 programs
and technologies in
development. However, you only depict six product candidates in the
pipeline table.
Additionally, we note you have four other programs identified on pages
147 and 148.
To the extent that the other 7 programs and technologies are not
material, please move the
chart and references to these programs and technologies to the
Business section where
they can be put in proper context.
6. Additionally, with respect to the total programs and technologies
chart, please clarify the
following:
Florian Brand
FirstName
ATAI Life LastNameFlorian Brand
Sciences B.V.
Comapany
March NameATAI Life Sciences B.V.
3, 2021
March3 3, 2021 Page 3
Page
FirstName LastName
Whether the programs attributed to each year, include the
number of continuing
programs from the prior year;
Whether there were any programs terminated during the
timeframe;
What minimum criteria was required for inclusion in the chart;
and
Which programs were acquired and which were created de novo.
7. Please disclose which of your product candidates were developed using
each of
EntheogeniX Biosciences and Introspect Digital Therapeutics.
Additionally, clarify
whether these programs were acquired to developed de novo.
8. We note that you do not hold a majority interest in gaba or
Neuronasal. Please explain the
extent to which you control the product candidate development and
clarify your financial
interest in the product candidate, such as rights to commercialization
rights, regulatory or
development milestone payments, etc.
Our Emerging Clinical and Preclinical Programs, page 4
9. We note statements throughout your that imply efficacy. For example
only, we note the
following statements you make regarding your product candidates:
"[PCN-101]
demonstrated a rapid and durable response" and "[DMX-102] demonstrated
rapid and
sustained efficacy in treating opioid use disorder." Please revise
your disclosure
throughout your prospectus to revise these and similar statements to
eliminate conclusions
or predictions that your product candidates are effective as
determinations of efficacy are
solely within the authority of the FDA or equivalent foreign
regulator. You may provide a
summary of the objective data that you used to draw these conclusions,
and such
discussion is more appropriate in the Business section where full and
proper context can
be provided.
Implications of Being an Emerging Growth Company, page 7
10. 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.
Collaborative relationships with third parties could cause us to expend
significant resources and
incur substantial business risk with..., page 53
11. In addition to your cross reference to Note 3 of you financial
statements, please quantify
the potential aggregate milestones payments outstanding that you may
be required to
make to maintain your current ownership percentages in your various
subsidiaries. In
addition, please expand your disclosure here, or in a separate risk
factor, to explain how
your majority owned operating subsidiaries could seek and accept
capital from third party
investors, thereby diluting your ownership and control over such
entities, without your
consent.
Florian Brand
FirstName
ATAI Life LastNameFlorian Brand
Sciences B.V.
Comapany
March NameATAI Life Sciences B.V.
3, 2021
March4 3, 2021 Page 4
Page
FirstName LastName
Use of Proceeds, page 99
12. We note your statement that the use of proceeds is to fund the
continued development of
your clinical and preclinical programs. Please revise you disclosure
to allocate the amount
of proceeds you expect to use for each of your programs and specify
how far in the
clinical development of yourproduct candidates you expect to reach
with the net proceeds.
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.
Business, page 126
13. Provide expanded disclosure of the CHIBA license agreement, the
Columbia stock
purchase and license agreement, the GABA preferred stock purchase
agreement, the
Neuronasal preferred stock purchase agreement, the DemeRx preferred
stock purchase
agreement and any other licensing or collaboration agreements related
to PCN-101, RL-
007, DMX-1002 or GRX-917 to provide:
each party's rights and obligations;
aggregate amounts paid to date;
aggregate potential milestone payments;
royalty provisions, quantified within a ten point range; and
term and termination provisions.
Please file the agreements or provide the basis for your belief they
are not required to be
filed as exhibits.
Our Enabling Technologies, page 135
14. We note your statement here that you believe your EntheogeniX joint
venture will
"accelerate drug discovery" and "be a project engine for atai." Please
explain how your
technology works and describe what makes the artificial intelligence
you are utilizing
"novel." In addition, disclose your basis for your belief that this
joint venture may be a
"project engine" or otherwise advise if any of your product candidates
have been
discovered by your joint venture.
Our Programs, page 136
15. Throughout this section you disclose third-party studies of certain
variations or different
formulations of your various product candidates. Please revise to
clearify whether the
prior trials were conducted on your actual product candidate versus a
similar product
candidate or different formulation.
16. In some instances you compare the results to other products. Please
clarify whether the
prior trials involved head to head studies. If they did not, remove
the disclosure
comparing the product candidate to another product.
Florian Brand
FirstName
ATAI Life LastNameFlorian Brand
Sciences B.V.
Comapany
March NameATAI Life Sciences B.V.
3, 2021
March5 3, 2021 Page 5
Page
FirstName LastName
Viridia Life Sciences (VLS-01), page 140
17. We note your disclosure that you believe your formulation of DMT has
"advantages,"
including "improved PK-Profile" and Short Duration of Psychedelic
Effect."
Please include a description of the objective data supporting these
claims.
Recognify Life Sciences (RL-007), page 141
18. We note your disclosure that "RL-007 demonstrated pro-cognitive
effects in three prior
clinical trials." However, we also note that these prior trials were
evaluating RL-007 for
the treatment of neuropathic pain. Please advise on how the
"pro-cognitive effects" were
measured or observed and explain whether the studies were powered to
show statistical significance.
Intellectual Property, page 151
19. Please revise your intellectual property disclosure to clearly
describe on an individual
basis the type of patent protection granted for each technology, the
expiration of each
patent held, and the jurisdiction of each patent. In this regard, it
may be useful to provide
this disclosure in tabular form to support the narrative already
included.
Note 5. Equity Method Investments and Other Investments
Equity Method Investments, page F-27
20. We note your investments in and advances to COMPASS Pathfinder Holding
Limited.
Refer to Rule 3-09 and Rule 1-02(w)(1) of Regulation S-X for guidance,
and provide us
with your significance calculations for COMPASS in regard to this
guidance. Tell us how
you evaluated whether separate financial statements for this
significant equity investee
would be material to investors and therefore required.
Note 12. Stock-Based Compensation, page F-83
21. 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 initial public offering 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. Please discuss with the staff how
to submit your
response.
You may contact Gary Newberry at 202-551-3761 or Kevin Vaughn at
202-551-3494 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jason Drory at 202-8342 or Suzanne Hayes at 202-551-3675 with any other
questions.
Florian Brand
ATAI Life Sciences B.V.
March 3, 2021
Page 6
FirstName LastNameFlorian Brand Sincerely,
Comapany NameATAI Life Sciences B.V.
Division of Corporation Finance
March 3, 2021 Page 6 Office of Life Sciences
FirstName LastName