United States securities and exchange commission logo
June 15, 2023
Erez Aminov
Chief Executive Officer
MIRA Pharmaceuticals, Inc.
900 West Platt Street, Suite 200
Tampa, FL 33606-2173
Re: MIRA
Pharmaceuticals, Inc.
Amendment No. 2 to
Draft Registration
Statement on Form S-1
Submitted June 8,
2023
CIK No. 0001904286
Dear Erez Aminov:
We have reviewed your amended 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.
Amendment No. 2 to Draft Registration Statement on Form S-1
Prospectus Summary
Our Product Candidate in Development
Our Clinical Development Program, page 6
1. We note your response
to prior comment 11 and revised disclosure on pages 6 and 53.
Please provide your
basis for your belief that an "overlapping (hybrid) Phase I and II can
be designed" for your
product candidate or otherwise advise. We note your disclosure that
you have not had any
discussions with the FDA regarding a hybrid trial design and you
disclose elsewhere that
"[a]fter the Phase I trial is complete, a Phase II trial will be
considered."
Erez Aminov
MIRA Pharmaceuticals, Inc.
June 15, 2023
Page 2
Risk Factors
Certain of our directors and officers may have actual or potential conflicts of
interest because of
their positions with MyMD, page 14
2. We note your response to prior comment 13, including that Dr. Adam
Kaplin, your
President and Chief Scientific Officer, will continue to serve as the
Chief Scientific
Officer of MyMD. In light of Dr. Kaplin's other business commitments,
please disclose
how much time Dr. Kaplin devotes to your operations.
Business
Mechanism of Action of MIRA1a, page 47
3. We note your response to prior comment 5 and reissue in part. We note
you continue to
describe MIRA1a as "more efficacious" and "more potent
anti-inflammatory, anti-seizure,
anticancer properties." In addition, we note your disclosure that "the
expected safety and
toxicity profile of MIRA1a should provide it with an edge over
existing
medicines." Please revise these disclosures and similar statements
that imply that your
product candidate is safe and effective or likely to be approved. You
may present
objective data resulting from your preclinical and clinical testing
without concluding
efficacy.
4. We note your graphic at the top of page 48 appears to depict "%
Efficacy" on the y-axis.
Please revise your disclosure to clarify what this means or otherwise
advise.
5. We note your statement that "[b]ased on preliminary results of [y]our
GPCR biosensor
assays, the CB2 receptor agonistic effects of MIRA1a are 8-fold more
potent than THC
and 30-fold more potent than CBD." Please update your disclosure to
clarify how your
assays measured the CB2 receptor agonistic effects or otherwise
advise.
6. We note your updated disclosure on pages 50-52, including your
description of the
"Thermal Sensitivity Model of Pain," "Trace Fear Conditioning Model of
Cognition
and "Psychomotor Vigilance Test" performed. For each study, please
revise your
disclosure to describe the material details of each study, including,
for example, who
performed the study and the number of subjects studied.
Our Market Advantage, page 54
7. We note your response to prior comment 18 and reissue in part. We note
your disclosure
states that "MIRA1a is the first cannabinoid that has demonstrated the
ability to rapidly
and significantly improve cognitive performance with acute use." Please
provide us your
FirstName LastNameErez Aminov
basis for claim that MIRA1a is the "first." In addition, please include
balancing disclosure
Comapany
here NameMIRA Pharmaceuticals,
when you refer Inc.
to the figures on page 4 and 51 to clarify that
the study preformed
was a non-human
June 15, 2023 Page 2 study that was not powered for statistical
significance.
FirstName LastName
Erez Aminov
FirstName LastNameErezInc.
Aminov
MIRA Pharmaceuticals,
Comapany
June NameMIRA Pharmaceuticals, Inc.
15, 2023
June 15,
Page 3 2023 Page 3
FirstName LastName
Amended and Restated Limited License Agreement with MyMD Pharmaceuticals, page
76
8. We note your response to prior comment 18 and re-issue in part. Please
disclose the
termination provisions of the license agreement with MyMD
Pharmaceuticals or
otherwise advise.
General
9. We note your response to comment 28 and re-issue. At first use, please
define
abbreviations throughout your amended draft registration statement.
For example only,
we note "THC" and "CBD" on page 1 and "cAMP" on page 48 do not appear
to be
defined.
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.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Curt Creely