Item 8.01 Other Events

MIRA Pharmaceuticals Announces Oral Mira-55 Outperformed Injected Morphine in Normalizing Pain and Reducing Inflammation, Supporting Its Planned IND for Chronic Inflammatory Pain

Findings show oral Mira-55 fully normalized pain and significantly reduced inflammation, supporting IND plans and reinforcing MIRA's position in a $70 billion non-opioid pain market.

On October 15, 2025, MIRA Pharmaceuticals, Inc. (the "Company") announced new preclinical data for Mira-55, its proprietary non-psychotropic marijuana analog, showing that oral administration of Mira-55 normalized pain and significantly reduced inflammation, outperforming injected morphine in an established animal model of chronic inflammatory pain.

This study marks the first time inflammation was directly measured alongside pain in the Mira-55 program. In the Company's prior study, only pain sensitivity was assessed, with both Mira-55 and morphine administered by injection. The new data demonstrate that orally administered Mira-55 provided superior pain normalization and direct anti-inflammatory effects, while morphine produced only partial and indirect inflammation reduction.

Key observations from the study include:

Reducing inflammation is fundamental to treating pain effectively. Inflammation drives nerve sensitization and amplifies pain signaling. Opioids block pain perception in the brain but do not treat inflammation, while NSAIDs address inflammation but carry safety concerns. By directly targeting inflammation through CB2 receptor activation, Mira-55 addresses both the cause and the perception of pain, offering a differentiated dual mechanism for chronic inflammatory pain conditions.

These findings support the Company's plan to pursue an Investigational New Drug (IND) application for chronic inflammatory pain and strengthen the scientific basis for advancing Mira-55 within its non-opioid pain franchise.