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United States securities and exchange commission logo
September 10, 2020
Leen Kawas, Ph.D.
Chief Executive Officer
Athira Pharma, Inc.
4000 Mason Road, Suite 300
Seattle, WA 98195
Re: Athira Pharma, Inc.
Registration
Statement on Form S-1
Filed August 26,
2020
Amendment No. 1 to
Registration Statement on Form S-1
Filed September 9,
2020
File No. 333-248428
Dear Dr. Kawas:
We have reviewed your 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 amending your registration
statement and providing the
requested information. 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 any amendment to your registration statement and
the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-1
Overview, page 1
1. We note your response
to prior comment 1. Your statement that "ATH-1017 significantly
improved brain activity
as measured by P300 latency, a functional measure that highly
correlates with
cognition" appears to imply an expectation that the improvement in P300
latency will result in
cognitive improvement as you state on page 8. Please revise this and
any similar statements
to clarify that you have yet to establish a connection between the
P300 latency results
observed in your Phase 1 trials and improved cognition. Please
further revise your
disclosure to provide appropriate context for various conclusions and
predictions as to the
performance of your product candidates and revise and/or remove
Leen Kawas, Ph.D.
FirstName LastNameLeen Kawas, Ph.D.
Athira Pharma, Inc.
Comapany 10,
September NameAthira
2020 Pharma, Inc.
September
Page 2 10, 2020 Page 2
FirstName LastName
any statements that imply efficacy. For example, please revise your
statement on page 2
that appears to conclude that your ATH platform has the ability to
enhance the body s
repair mechanism of HGF/MET and the last sentence under
"Differentiated Approach"
on page 7 that appears to conclude that treatment with ATH-1017 will
produce certain
beneficial effects. Please remove the row related to ATH-1017 from the
chart on page 8 as
the disclosure makes a prediction regarding the efficacy of the
treatment as noted above.
We note your disclosure on page 4 that "average latency across the AD
treatment group
had returned to levels close to those observed in healthy elderly
subjects by the end of an
8-day treatment cycle" and a similar statement on page 135 that
ATH-1017 normalized
the P300 latency of AD subjects in a Phase 1b clinical trial within 8
days of treatment.
Please remove any reference to normalization as it implies efficacy
and instead present
the data that you used to draw the conclusion. Please also disclose
how you selected the
healthy young and healthy elderly volunteers in your Phase 1 clinical
trials and how you
determined that they were healthy.
Our Pipeline and ATH Platform, page 2
2. We note your disclosure that you may cross-reference the already
active IND for ATH-
1017 for the treatment of AD in the second IND for ATH-1017 for the
treatment of PDD.
Please revise your disclosure to clarify whether the second IND for
PDD has been
submitted to the FDA. If not yet submitted, please move the line for
PDD to reflect its
current status in pre-clinical development. We note your response to
prior comment 3 that
the company intends to initiate the Phase 2/3 LIFT-AD clinical trial
in early September
yet your disclosure in the prospectus indicates that the company
intends to initiate the trial
by the end of 2020. Until you initiate the trial, please remove any
references to the
company being in the "late" clinical-stage.
Risks Associated with Our Business, page 9
3. We note your response and revisions to prior comment 7. Please revise
this section to
highlight the risks associated with using EEG methods and the risks
associated with
having limited data from only 11 AD subjects from your Phase 1 trials.
Insights from Approved Therapies, page 120
4. We note your revised disclosure in response to prior comment 10.
Please revise to make
the disclosure added to the Source note below Figure 12 part of the
lead-in paragraph to
Figure 12. Please also revise your disclosure to clarify whether the
similarities disclosed
between the studies of donepezil and rivastigmine are also the same
for the ATH-1017
Phase 1 clinical trial. We note, for example, that there is no trend
line for a placebo
control in the ATH-1017 graph and that the subjects included both
healthy and AD
patients. If not similar to the studies of donepezil and rivastigmine,
please revise to
disclose why such comparisons are appropriate or remove the
comparisons.
Leen Kawas, Ph.D.
FirstName LastNameLeen Kawas, Ph.D.
Athira Pharma, Inc.
Comapany 10,
September NameAthira
2020 Pharma, Inc.
September
Page 3 10, 2020 Page 3
FirstName LastName
Event-Related Potential, page 128
5. We note your response to prior comment 11. Please revise your
disclosure to include a
discussion of the objective data observed to support your statement
that "the sustained
effects on P300 latency observed in the pre-dose recordings on
subsequent testing
days...most likely reflect the long-term regeneration of neuronal
connections and the
improvement in brain function." Alternatively, please remove the
statement.
Our Neuropsychiatric Program (ATH-1019), page 134
6. We note your response to prior comment 12. Please revise your
disclosure to include a
discussion of the objective data observed to support your statement
that ATH-1019 "has
been shown to activate the HGF/MET system, and distribute to the CNS,
and is
neuroactive in animal models." Alternatively, you may describe what
you have designed
ATH-1019 to do and remove the statement.
Our Collaboration and Grant Agreements
Washington State University Research Foundation License Agreement and Amended
and
Restated Washington State University License Agreement , page 140
7. We note your response to prior comment 13. Please note that we
consider the royalty term
to be a material term of a license agreement that should be disclosed
in the registration
statement. Please disclose when the royalty term is currently expected
to expire. We note
your disclosure that the term of the agreement will continue until the
earlier of the date
that no valid claim in a licensed patent remains enforceable or
payment of earned
royalties, once such payments begin, ceases for more than four
consecutive calendar
quarters. Please revise to disclose when the licensed patents are
currently expected to
expire. Please also revise your disclosure in this section to include
the information from
your response regarding whether you expect the joint ownership of the
patent with Pacific
Northwest Biotechnology, Inc. to have any effect on your license of
the patent or your
development of the product candidates to which the patent relates.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
You may contact Michael Fay at 202-551-3812 or Daniel Gordon at
202-551-3486 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Deanna Virginio at 202-551-4530 or Ada D. Sarmento at 202-551-3798 with
any other
questions.
Leen Kawas, Ph.D.
Athira Pharma, Inc.
September 10, 2020
Page 4
Sincerely,
FirstName LastNameLeen Kawas, Ph.D.
Division of Corporation Finance
Comapany NameAthira Pharma, Inc.
Office of Life Sciences
September 10, 2020 Page 4
cc: Michael Nordtvedt, Esq.
FirstName LastName