Material Event (Form 8-K)

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, the U.S. topical pain relief market is projected to exceed $11.5 billion in 2025, driven by increased demand for non-opioid, localized therapies that minimize systemic exposure. MIRA believes its dual-route Ketamir-2 strategy is uniquely positioned to engage both systemic and topical treatment markets.

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.