United States securities and exchange commission logo
April 29, 2021
Gerald Proehl
President and Chief Executive Officer
Dermata Therapeutics, Inc.
3525 Del Mar Heights Rd., #322
San Diego, CA 92130
Re: Dermata
Therapeutics, Inc.
Draft Registration
Statement on Form S-1
Submitted April 2,
2021
CIK No. 0001853816
Dear Mr. Proehl:
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 April 2, 2021
Prospectus Summary
Our Clinical Development Pipeline, page 1
1. We note your disclosure
that you intend to advance the clinical development of DMT410
for the treatment of
various aesthetic indications, whereas your product pipeline table
shows that, in addition
to aesthetic conditions, DMT410 is currently in development for
hyperhidrosis. If you
do not intend to pursue the development of DMT-410 for the
treatment of
hyperhidrosis, please remove this indication from your pipeline table as your
pipeline table should
present only programs that are material to your business. We will
not object to footnote
or other explanatory disclosure indicating, if true, that you intend
to rely on Phase 1
clinical trial data for hyperhidrosis to support your trial design or
Gerald Proehl
FirstName LastNameGerald
Dermata Therapeutics, Inc. Proehl
Comapany
April NameDermata Therapeutics, Inc.
29, 2021
April 229, 2021 Page 2
Page
FirstName LastName
marketing application for aesthetic indications.
Summary of Risks Associated with Our Business, page 4
2. Please add a bullet point highlighting the risks related to the
concentration of ownership of
your common stock, as referenced on page 56.
Risk Factors
Our amended and restated certificate of incorporation will designate the Court
of Chancery of the
State of Delaware..., page 58
3. Please revise to disclose that there is also a risk that your forum
selection provisions may
result in increased costs for investors to bring a claim.
Use of Proceeds, page 63
4. We note your disclosure that you expect to use net proceeds from this
offering to advance
the clinical development of DMT310 for the treatment of rosacea and
psoriasis. For each
indication, please revise your disclosure to specify how far in the
clinical development of
the associated product candidates you expect to reach with the net
proceeds. If any
material amounts of other funds are necessary to complete your
clinical trials for these
candidates, please revise your disclosure to state the amounts and the
sources of such
other funds. Refer to Instruction 3 of Item 504 of Regulation S-K.
Please also separately
quantify the approximate amount intended to be used to advance the
clinical development
of DMT410 for the treatment of various aesthetic indications and any
additional
indications.
Capitalization, page 66
5. Please ensure that your capitalization table reflects your most recent
debt and capital
structure, which would include any outstanding preferred securities,
for the actual
column.
Managements Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations for the Year Ended December 31, 2019 and 2020, page 76
6. Please disclose your research and development expenses by product
candidate for each
period presented. To the extent that you do not track expenses by
product candidate,
please disclose as such and why.
Business
Our Clinical Development Pipeline and Product Candidates, page 84
7. We note your comparison of the results of your open-label Phase 1b POC
clinical trial of
DMT410 in 10 axillary hyperhidrosis patients to results seen in
clinical trials using
between 10 and 20 injections of BOTOX. Since it does not appear that
you have
conducted head-to-head trials, please revise your disclosure to
clearly state this fact and
Gerald Proehl
FirstName LastNameGerald
Dermata Therapeutics, Inc. Proehl
Comapany
April NameDermata Therapeutics, Inc.
29, 2021
April 329, 2021 Page 3
Page
FirstName LastName
tell us why you believe these comparisons are appropriate. Address in
your response
whether you expect to be able to rely on such comparisons to support
an application for
marketing approval.
Spongilla's Multiple Mechanism of Actions, page 88
8. We note your disclosure stating that organic material that binds
spicules together contains
chemical compounds that you have found to be effective in-vitro in
inhibiting various
facets of skin diseases and conditions. Please revise this statement
and similar statements
throughout your registration statement that present your conclusion
that your product
candidate is safe or effective as safety and efficacy determinations
are made solely by the
U.S. Food and Drug Administration and comparable foreign regulators.
Where you deem
appropriate, you may present objective data resulting from your trials
without including
your conclusions related to safety or efficacy. As examples only, we
note the following
disclosures:
With positive results for DMT410 in hyperhidrosis....
Our technology has demonstrated anti-microbial activities
directly against cultured C.
acnes.
We have also found that the organic material in our sponge
reduces sebum production
by inhibiting lipogenesis of sebocytes, resulting in reduced
oiliness of the skin.
The safety profile of DMT310 was extremely favorable with no
reported drug-related
severe adverse events.
Intellectual Property, page 101
9. Please revise your intellectual property disclosure to clearly
describe on an individual
basis the type of patent protection granted for each technology
(composition of matter,
use, or process), the expiration of each patent held, and the
jurisdiction, including any
foreign jurisdiction, of each pending or issued patent. In this
regard, it may be useful to
provide this disclosure in tabular form to support the narrative
already included.
Material Agreements
License Agreement between Dermata Therapeutics, LLC and Villani, Inc., page 103
10. Please revise to disclose the aggregate amounts paid to date under the
agreement. In this
regard, we note your disclosure in Note 11 of the Notes to Financial
Statements
regarding Villani s claim for milestone payments of $250,000 and
$500,000.
Additionally, please disclose the aggregate amount of potential
milestone payments
broken down by regulatory development and commercial sales milestones.
Please
also describe the material terms of the License Amendment and
Settlement Agreement
and revise to quantify the value of the 5,221,156 units of our Series
1c Preferred Units
issued to Villani at the time of issuance.
Gerald Proehl
Dermata Therapeutics, Inc.
April 29, 2021
Page 4
Supply Agreement between Dermata Therapeutics LLC and Reka-Farm LLC, page 104
11. Please revise to disclose the term of the supply agreement.
3. Summary of Significant Accounting Policies
Net Loss Per Common Unit, page F-9
12. Please revise to disclose the number of securities that could potentially
dilute basic EPS in
the future as required by ASC 260-10-50-1.c.
13. Subsequent Events, page F-16
13. Please disclose the specific date through which subsequent events were
evaluated in
accordance with ASC 855-10-50-1.
General
14. 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 Tracey Houser at 202-551-3736 or Daniel Gordon at
202-551-3486 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Kasey Robinson at 202-551-5880 or Christine Westbrook at 202-551-5019
with any
other questions.
Sincerely,
FirstName LastNameGerald Proehl
Division of
Corporation Finance
Comapany NameDermata Therapeutics, Inc.
Office of Life
Sciences
April 29, 2021 Page 4
cc: Steven Skolnick, Esq.
FirstName LastName