| Description of business and summary of significant accounting policies | Note
1. Description of business and summary of significant accounting policies Overview MIRA
Pharmaceuticals, Inc., a Florida corporation (“we,” “us,” “our,” “MIRA,” or the “Company”),
is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric
disorders. The Company holds exclusive license rights in the U.S., Canada and Mexico for Ketamir-2, a novel, patent pending oral ketamine
analog under pre-clinical investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling
treatment-resistant depression (“TRD”), major depressive disorder with suicidal ideation (“MDSI”), and potentially post-traumatic
stress disorder (“PTSD”). Additionally,
the Company’s novel oral pharmaceutical marijuana, MIRA-55, is currently under investigation for its potential to alleviate neuropathic
pain, as well as anxiety and cognitive decline, symptoms often associated with early-stage dementia. MIRA-55, if approved by the U.S.
Food and Drug Administration (“FDA”), could mark a significant advancement in addressing various neuropsychiatric, inflammatory,
and neurologic diseases and disorders. The
U.S. Drug Enforcement Administration’s (“DEA”) scientific reviews of both Ketamir-2 and MIRA-55 concluded that they
would not be considered a controlled substance or listed chemical under the Controlled Substances Act (“CSA”) and its governing
regulations. The
Company is incorporated under the laws of the State of Florida in September 2020 and commenced substantive operations, including our
pharmaceutical development program, in late 2020. The Company’s accounting and reporting policies conform to accounting principles
generally accepted in the United States of America (“GAAP”). As
used herein, the Company’s Common Stock, par value $ 0.0001 0.0001 Operating
Updates In
early February 2024, the Company made a significant discovery during the manufacturing and scale-up process of its patented molecule
known as “MIRA1a,” which the Company believed was the molecule used in its pre-clinical trials and had been synthesized by
a contract manufacturer. Through this process, the Company identified a novel and improved version of the molecule, which the Company
calls MIRA-55. As
part of the Company’s due diligence and subsequent testing, which began in late 2023, the Company discovered that the pre-clinical
studies the Company conducted, previously attributed to MIRA1a, were in fact performed on MIRA-55. Following this revelation, in early
March 2024, the Company promptly filed a provisional patent for MIRA-55, which encompasses all pre-clinical studies. If such patent is
issued, the Company will own the patent rights to both MIRA1a and MIRA-55. Moreover,
based on the Company’s pre-clinical analyses to date, the Company believes that MIRA-55 is an improvement over MIRA1a in that it
displays enhanced potency and potential for efficacy. Based
on the Company’s discoveries and pre-clinical studies to date, the Company has decided to advance MIRA-55 as its lead compound
for the Company’s oral pharmaceutical marijuana drug candidate while still retaining its rights to MIRA1a. As such, the Company’s
decided not to move MIRA1a forward. Significant
Accounting Policies There
have been no material changes in the Company’s significant accounting policies from those previously disclosed in the 2023 Annual
Report. |
