Company: MIRA
Filing Date: 2025-04-23
Form Type: 8-K
Source: 0001641172-25-005772
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Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-04-23
Form: 8-K
Item: Item 8.01
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Item
8.01 Other Events

MIRA
Pharmaceuticals, Inc. (NASDAQ: MIRA), or MIRA, today announced a key development milestone that may significantly advance the Company’s
topical drug pipeline: its novel topical formulation of Ketamir-2 demonstrated successful, dose-proportional drug release in a validated
laboratory study, marking a critical step forward in the program’s progression toward clinical testing.

The
results of the in vitro release testing (IVRT) confirm that Ketamir-2 can be delivered reliably and consistently through a topical cream - a
challenge that many water-soluble compounds fail to overcome when formulated in hydrophobic bases. This breakthrough provides MIRA with
a new opportunity to pursue localized, non-opioid pain treatment options that may complement its oral Ketamir-2 formulation currently
in Phase 1 trials.

“ This
is not just a formulation milestone - it’s a strategic inflection point,” said Erez Aminov, Chairman and CEO of MIRA.
“ With both oral and topical path now in motion, we’re targeting a much broader market and moving closer to providing multiple
therapeutic options to address the growing burden of pain.”

MIRA
is now initiating preclinical efficacy studies to assess whether the topical formulation can offer therapeutic effects in models of inflammatory
and neuropathic pain. These studies are expected to provide data to guide potential clinical advancement.

MIRA
is also evaluating whether the topical Ketamir-2 program may meet the criteria for Fast Track designation under the United States Food
and Drug Administration (“ FDA”)’s expedited development program for serious conditions. If granted, Fast Track status
could facilitate closer communication with the FDA and potentially accelerate the path to first-in-human studies.

The
potential significance of this development is further underscored by the market opportunity it addresses. According to The Business
Research Company

MIRA’s
oral Ketamir-2 formulation is currently being evaluated in a Phase 1 clinical trial, with a Phase 2a trial in diabetic neuropathy expected
to commence later this year.

SIGNATURES

Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.

                             MIRA PHARMACEUTICALS, INC.                               
  Dated: April 23, 2025      By:                             /s/ Erez Aminov