United States securities and exchange commission logo
May 29, 2023
Erez Aminov
Chief Executive Officer
MIRA Pharmaceuticals, Inc.
900 West Platt Street, Suite 200
Tampa, FL 33606-2173
Re: MIRA
Pharmaceuticals, Inc.
Draft Registration
Statement on Form S-1
Submitted May 2,
2023
CIK No. 0001904286
Dear Erez Aminov:
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
Cover Page
1. Please disclose, if
accurate, that the closing of this offering is contingent upon a Nasdaq
Listing, or otherwise
advise. Please ensure the disclosure is consistent with your
underwriting agreement.
2. We note that you have
checked the Rule 415 box on your outside cover page, yet
disclosures elsewhere
indicate that this is a firm commitment, underwritten offering.
Please advise or
revise.
Erez Aminov
FirstName LastNameErezInc.
Aminov
MIRA Pharmaceuticals,
Comapany
May NameMIRA Pharmaceuticals, Inc.
29, 2023
May 29,
Page 2 2023 Page 2
FirstName LastName
Prospectus Summary, page 1
3. The disclosure in the summary should be a balanced presentation of
your business. Please
balance your prospectus summary by including disclosure regarding your
limited
operating history and your history of net losses.
4. We note your disclosure in reference to studies suggesting that
MIRA1a may be capable
of unmasking positive therapeutic effects not previously seen with
THC. Please specify
that these are preclinical studies, or otherwise advise.
5. We note that disclosures here, and elsewhere in the prospectus,
include statements or
implications that your product candidates are safe and/or effective.
Please revise these
statements, as safety and efficacy determinations are in the exclusive
purview of the FDA
or other regulators. For example only, the following statements
improperly state or imply
that your product candidates are safe or effective:
On page 2, your product candidate is "likely much more efficacious
as a potential
therapeutic for inflammatory, autoimmune, and neurodegenerative
conditions."
On page 2, that you found MIRA1a has potent anti-anxiety
effects.
On page 7, your belief that MIRA1a s expected safety and
toxicity profile should
provide an edge over existing medicines categories.
On page 7, that you will be "using a safe, effective and
FDA-approved treatment
option."
Pre-Clinical Developments and Studies, page 2
6. We note your disclosure of pre-clinical trials relating to your
product candidate
throughout this section. Please revise to clarify whether each trial
was powered for
statistical significance. In addition, if a trial was powered for
statistical significance please
provide p-values for the results of each trial.
7. At the top of page 3 you have a table of pre-clinical tests. Please
revise your disclosure to
clarify what "Group 1" and "Group 2" actually mean. In addition, we
note that you include
descriptions, including the results, of only some of your pre-clinical
studies completed to
date. If a pre-clinical study is material, please expand your
disclosure in your Business
section to provide a more fulsome discussion of the study design as
well as the objective
results.
Market Opportunity, page 6
8. We note your statistics on page 6 reference the global market for
medicines as well as
the United States market. We also note your disclosure on page 1 that
your treatment is
geared towards a particular demographic, namely, adult patients with
anxiety and
cognitive decline typically associated with early-stage dementia, as
well as those with
chronic pain. Please revise your disclosure or otherwise provide
additional context on why
the global and domestic statistics for all medicines is relevant given
your current product
candidate's apparent more narrow potential indications.
Erez Aminov
FirstName LastNameErezInc.
Aminov
MIRA Pharmaceuticals,
Comapany
May NameMIRA Pharmaceuticals, Inc.
29, 2023
May 29,
Page 3 2023 Page 3
FirstName LastName
9. We note your reference on page 6 to an IQVIA Report that specifies
statistics about the
global CNS market, and that anxiety is worth between
approximately $20 billion and
$25 billion in annual sales. We also note your disclosure on page 7
that you currently
have no plans to develop the MIRA1a compound for approval and
commercialization
outside of the United States, and that your license is for research
and development
activities as well as for commercial uses in the United States. Please
tell us whether the
global statistic is an accurate depiction of the market opportunity
for your Company,
particularly in light of the geographic scope of your current license,
or otherwise advise.
10. We note your disclosure that another "key market will be the
traditional pain market,
which the IQVIA Report estimates will be worth $42 billion in 2027 and
grow between
three and six percent during the forecast period." Please specify
whether the estimates are
for a domestic or global market, or otherwise advise.
Our Clinical Development Program, page 6
11. We note your disclosure on page 6, and elsewhere, that an overlapping
(hybrid) Phase I
and Phase II can be designed and allowed to proceed by the FDA,
allowing you to
accelerate the development of MIRA1a. Please provide balancing
disclosure here, and
elsewhere, that there is no guarantee the FDA will provide such
approval and disclose
whether you or your representatives have had any conversations with
the FDA regarding
an "overlapping" trial design. Finally, please revise this statement
and any similar
disclosure to remove any implication that you will be successful in
developing your
product candidate in a rapid or accelerated manner as such statements
are speculative.
12. We note your statement on page 6 that a Phase II trial for your first
IND application "is
planned to commence by the end of the fourth quarter of 2024" and a
Phase II trial will
begin in the third quarter of 2026" for your second IND application.
Given the lengthy
timeline and uncertainty with regard to clinical development, please
remove
these statements as it appears to be premature and speculative given
your stage of
development.
Risk Factors, page 14
13. In light of your relationship with MyMD, please consider including a
risk factor
discussing risk resulting from any conflicts of interest or the
appearance of conflicts of
interest. In this regard, we note that certain of your executive
officers are also senior
management within MyMD. We also note your disclosures on page F-9 that
"[t]he
Company and MYMD have similar members of the Board, as well as
officers from the
respective companies."
Use of Proceeds, page 39
14. We note your disclosure that you cannot specify with certainty the
particular uses of the
net proceeds that you will receive from this offering. Please revise
your use of proceeds
disclosure to provide more granularity regarding the first bullet
point, namely how far in
Erez Aminov
FirstName LastNameErezInc.
Aminov
MIRA Pharmaceuticals,
Comapany
May NameMIRA Pharmaceuticals, Inc.
29, 2023
May 29,
Page 4 2023 Page 4
FirstName LastName
the development process you estimate that the proceeds will enable you
to reach,
including specific phases of clinical trials, if applicable. In this
regard, we note your
disclosure on page 22 that you have significant and increasing
liquidity needs and may
require additional funding.
Capitalization, page 41
15. Please include debt in the capitalization table as a component to
determining your total
capitalization.
Management's Discussion and Analysis and Results of Operations
Results of Operations, page 44
16. For each of the periods presented, please quantify each factor
identified for the
increase/decrease in each of your expense line items. As part of your
response, please
address the following:
Please revise your results of operations to provide a quantified
breakdown of your
research and development expense by nature or type of expense, and
discuss each
component, as applicable.
Disclose how much of your $1.3 million in stock compensation
expense was
applicable to general and administrative expense and research and
development
expense.
Business
Market Opportunity, page 53
17. We note your graphic disclosure depicting the total addressable
population on page 54.
Please identify the referenced published literature, and provide
a more detailed
discussion of the underlying assumptions used in your calculations.
Our Market Advantage, page 54
18. We note your disclosures that "MIRA1a is the first cannabinoid that
has demonstrated the
ability to improve cognitive performance in pre-clinical studies."
Please provide your
basis for this statement. In addition, we note your disclosures on
page 17 that conclusions
based on your pre-clinical data may prove inaccurate, and are not
necessarily predictive
indicators of future results. Please provide balancing disclosure
here, and elsewhere,
regarding any conclusions and predictions you make based on
preclinical studies.
19. We note your disclosure regarding the DEA s determination and your
belief that MIRA1a
has a distinct competitive advantage by being poised to move through
the regulatory
approval process at a faster pace than that of competing
scheduled product candidates.
Please remove this statement as the DEA s determination may not
lead to a faster
development or regulatory process, and also does not increase the
likelihood that the
product candidate will receive approval by the FDA. We further note
your disclosure that
your Company is positioned to enjoy market exclusivity in the United
States upon
Erez Aminov
FirstName LastNameErezInc.
Aminov
MIRA Pharmaceuticals,
Comapany
May NameMIRA Pharmaceuticals, Inc.
29, 2023
May 29,
Page 5 2023 Page 5
FirstName LastName
receiving regulatory approval. Please remove this statement as
there is no guarantee that
your product candidates will receive regulatory approval by the FDA or
similar regulatory
body.
Intellectual Property, page 56
20. We note your disclosure here that you own U.S. Patent 10,787,675 B2.
Please disclose the
expiration date of the patent.
Amended and Restated Limited License Agreement with MyMD Pharmaceuticals, page
76
21. We note your disclosure on page 7, and elsewhere, regarding the
perpetual license you
have with MyMD Pharmaceuticals, Inc. to use MyMD s Supera-CBD as a
synthetic
intermediate in the manufacture of MIRA1a for research and development
activities as
well as for commercial uses in the United States. We also note your
disclosure on F-9 that
you have entered into a non-exclusive, royalty-free license to use
MYMD s Supera-CBD
as a synthetic intermediate in the manufacture of MIRA1a for research
and development
activities relating to your planned pre-clinical and clinical studies.
Please disclose, if
accurate, that this is a non-exclusive license, or otherwise advise.
In addition, please
disclose the material terms of the agreement, including amounts paid
to date, future
potential payments, royalty provisions, and termination provisions or
otherwise advise.
We note the agreement appears to cover "commercial uses" in addition
to research and
development activities.
22. We note your disclosure that you have the "right to use MyMD s
Supera-CBD as a
synthetic intermediate in the manufacture of MIRA1a for research and
development
activities as well as for commercial uses in the United States."
Please clarify whether there
are other third parties or other "synthetic intermediates" for which
you could use to
manufacture your product candidate, MIRA1a. To the extent MyMD is your
sole supplier
for your "synthetic intermediate" in the manufacture of MIRA1a, please
disclose the risk
relating your reliance on a sole-supplier and please disclose whether
you believe alternate
sources of the "synthetic intermediate" are available, or otherwise
advise.
Certain Relationships and Related Party Transactions
Line of Credit and Promissory Note with the Bay Shore Trust, page 76
23. Please tell us your accounting analysis with regards to the common
stock purchase
warrant issued to Bay Shore Trust citing supportive, authoritative
accounting guidance,
and revise to disclose your accounting for the warrant, providing
quantification as
applicable.
Note 5. Related party transactions, page F-7
24. Confirm, if true, that all related party transactions are separately
quantified on the face of
your statement of operations.
Erez Aminov
FirstName LastNameErezInc.
Aminov
MIRA Pharmaceuticals,
Comapany
May NameMIRA Pharmaceuticals, Inc.
29, 2023
May 29,
Page 6 2023 Page 6
FirstName LastName
Notes to the Financial Statements
Note 1. Description of business and summary of significant accounting policies
Research and Development Expenses, page F-7
25. You disclose on page 44 that legal costs included in your general and
administrative expense line item include patent costs. However, you
also disclose on page
F-7 that your research and development expenses include patent-related
costs. Please
address the following:
Revise to reconcile the apparent inconsistency between these
disclosures.
Further, tell us how you considered the guidance of ASC
730-10-55-2(i), which
outlines the type of patent costs that must be excluded from
research and
development expenses.
Note 8. Stockholders' Equity
Stock Based Compensation, page F-12
26. 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.
General
27. 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.
28. At first use, please define abbreviations throughout your draft
registration statement. For
example only, we note that "MTD/7D" and "DRF" on page 5, which do not
appear to be
defined.
29. Please ensure the writing is legible in the visual depictions
throughout your draft
registration statement. For example only, your visual at the top of
page 2, contains legends
and text on the y-axis that are not legible and with respect to the
Pain Reduction
Thermal Sensitivity visual on page 4, the writing above and below the
yellow bar is not
legible.
You may contact Sasha Parikh at 202-551-3627 or Kevin Vaughn at
202-551-3494 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jimmy McNamara at 202-551-7349 or Jason Drory at 202-551-8342 with any
other
questions.
Erez Aminov
MIRA Pharmaceuticals, Inc.
May 29, 2023
Page 7
Sincerely,
FirstName LastNameErez Aminov
Division of Corporation Finance
Comapany NameMIRA Pharmaceuticals, Inc.
Office of Life Sciences
May 29, 2023 Page 7
cc: Curt Creely
FirstName LastName