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United States securities and exchange commission logo
August 18, 2020
Marcio Souza
Chief Executive Officer
Praxis Precision Medicines, Inc.
One Broadway, 16th Floor
Cambridge, MA 02142
Re: Praxis Precision
Medicines, Inc.
Draft Registration
Statement on Form S-1
Submitted July 22,
2020
CIK No. 0001689548
Dear Mr. Souza:
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 on Form S-1
Prospectus Summary
Company Overview, page 1
1. We note your statements
indicating that your therapeutics are potentially "best-in-class" or
"first-in-class." These
terms suggest that your product candidates are effective, likely to be
approved and favorable,
as compared to competitive products and product candidates.
Given the status of
development, it is premature for you to make such statements or
implications at this
time. Accordingly, please delete all references in your registration
statement to your
product candidates being potentially "best-in-class" or "first-in-class." If
your use of these terms
was intended to convey your belief that the products are based on
a novel technology or
approach and/or is further along in the development process, you
Marcio Souza
FirstName LastNameMarcio Souza
Praxis Precision Medicines, Inc.
Comapany
August 18, NamePraxis
2020 Precision Medicines, Inc.
August
Page 2 18, 2020 Page 2
FirstName LastName
may discuss how your technology differs from technology used by
competitors and, if
applicable, that you are not aware of competing products that are
further along in the
development process. Statements such as these should be accompanied by
cautionary
language that the statements are not intended to give any indication
that the product
candidates have been proven effective or that they will receive
regulatory approval.
2. Please revise your statement that you own global commercialization
rights for all of your
product candidates with reference to your financial obligations under
your license and
collaboration agreements as discussed on pages 154-156.
3. We note your disclosure that you intend to initiate the first of two
registrational trials,
Phase 2/3, in the United States and Australia. Your characterization
of two trials as
registrational is not appropriate given that you must complete
multiple trials prior to
submitting the related New Drug Application (NDA). Please revise your
disclosure to
remove this characterization here and throughout your prospectus.
PRAX-114, page 2
4. We note your disclosure that you have an ongoing three-part Phase 2a
clinical trial
ongoing in Australia, with Part A having demonstrated rapid and marked
improvements in
depression scores in MDD patients. As efficacy determinations are
solely within the
authority of the U.S. Food and Drug Administration (FDA) and
comparable regulatory
bodies, it is inappropriate to state or imply that your product
candidates are effective.
Please revise this statement and similar statements here and
throughout your prospectus,
including, but not limited to, in your Business section. We will not
object to a discussion
of objective data resulting from your trials without including
conclusions related to
efficacy. As a non-exhaustive list of illustrative examples only, we
note the following
disclosures:
To date, PRAX-562 has demonstrated efficacy in in vivo models...
Based on clinical data showing a rapid, pronounced and durable
antidepressant effect
in MDD patients...
We plan to initiate a Phase 2 trial for Short-lasting Unilateral
Neuralgiform headache
with Conjunctival injection and Tearing, or SUNCT, and
Short-lasting
Unilateral Neuralgiform headache attacks with Autonomic symptoms,
or SUNA, to
demonstrate rapid clinical proof-of-concept and then subsequently
expand into severe
pediatric epilepsies.
Because the doses at which EEG changes observed in rats are
similar to those that
demonstrated efficacy in a preclinical model of essential
tumor....
We have evaluated the safety and tolerability of PRAX-944 in over
100 healthy
volunteers in four separate clinical trials and demonstrated
pharmacodynamic effects
in humans using EEG.
Marcio Souza
FirstName LastNameMarcio Souza
Praxis Precision Medicines, Inc.
Comapany
August 18, NamePraxis
2020 Precision Medicines, Inc.
August
Page 3 18, 2020 Page 3
FirstName LastName
Our Strategy, page 4
5. We note that you state your strategy is to "efficiently advance" your
product candidates
towards regulatory approval and commercialization. Please revise your
disclosure to
remove any implication that you may be able to accelerate the FDA
review process.
Risks Associated with Our Business, page 5
6. Please expand your disclosure in the fourth bulletpoint to highlight
the risk that your
clinical trials to date have been conducted outside the U.S. and that
if the FDA or
comparable regulators do not accept earlier preclinical and clinical
data you may need to
conduct additional clinical trials, as referenced on pages 16 and 24.
Please also add a
bullet point highlighting the risks related to concentration of
ownership of your common
stock, as referenced on page 73.
Use of Proceeds, page 82
7. It appears from your disclosure that the proceeds from the offering
will not be sufficient to
fund development of your product candidates through regulatory
approval and
commercialization. Please disclose the sources of other funds needed
to reach regulatory
approval and commercialization for each product candidate. Refer to
Instruction 3 to Item
504 of Regulation S-K.
Business
Our Approach, page 116
8. Please expand your disclosure to explain briefly what you mean by
"validated" target-
specific EEG endpoints. Additionally, please define "CHO cells" used
on page 122.
Broad Psychiatry and Neurology Programs
PRAX-114
Phase 2a trial in patients with depression
Part A results, page 127
9. We note your comparison of the results of PRAX-114 observed in your
Phase 2a Part A
trial to published reports on changes in HAM-D scale in clinical
trials of approved
antidepressants. As these comparisons are not based on head-to-head
studies, please tell us
why you believe it is appropriate to include them. Address in your
response whether you
expect to be able to rely on such comparisons to support an
application for marketing
approval.
Marcio Souza
Praxis Precision Medicines, Inc.
August 18, 2020
Page 4
License Agreement with RogCon, page 154
10. We note your disclosure that the $3.0 million milestone payment will
become due to
RogCon when the first profit share payment has become due and certain
certain
contingent payments become due to Ionis. Please expand your disclosure to
specify the
triggers for these payments.
Ionis Collaboration Agreement, page 155
11. Please expand your disclosure to include the financial terms related to
the option exercise
provisions, including the royalty rate or range not to exceed ten
percentage points.
License Agreement with Purdue, page 155
12. Please expand your disclosure to include the period of time relevant to
the royalty term.
General
13. 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.
You may contact Gary Newberry at 202-551-3761 or Kate Tillan at
202-551-3604 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Courtney Lindsay at 202-551-7237 or Christine Westbrook at 202-551-5019
with any
other questions.
Sincerely,
FirstName LastNameMarcio Souza
Division of
Corporation Finance
Comapany NamePraxis Precision Medicines, Inc.
Office of Life
Sciences
August 18, 2020 Page 4
cc: William D. Collins, Esq.
FirstName LastName