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Mira Pharma SEC Filings

MIRA NASDAQ

Welcome to our dedicated page for Mira Pharma SEC filings (Ticker: MIRA), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.

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Form 8-K Item 8.01 – Other Events

On 30 June 2025, MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) disclosed pre-clinical data for SKNY-1, an oral therapeutic it is under definitive agreement to acquire from SKNY Pharmaceuticals. In a zebrafish model simulating human obesity and craving behaviour, six-day oral dosing produced an approximate 30 % body-weight reduction, leaving treated animals 10 % lighter than healthy controls while preserving muscle density. Metabolic indicators improved, including higher ventilation rate, normalised liver fat, and restoration of both LDL and HDL cholesterol to healthy levels without raising circulating triglycerides.

Behaviourally, SKNY-1 dose-dependently suppressed high-calorie consumption, reduced compulsive food seeking, and eliminated nicotine-seeking even under stress. The compound also normalised leptin and ghrelin and, at lower doses, reduced elevated dopamine linked to reward cravings.

The company states that these results warrant advancement into IND-enabling studies and positions SKNY-1 as a potential cornerstone asset once the acquisition closes, citing a combined obesity and smoking market opportunity exceeding US$200 billion.

The filing does not include human data, transaction financials, development costs, or projected timelines.

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FAQ

What is the current stock price of Mira Pharma (MIRA)?

The current stock price of Mira Pharma (MIRA) is $1.245 as of June 28, 2025.

What is the market cap of Mira Pharma (MIRA)?

The market cap of Mira Pharma (MIRA) is approximately 19.7M.

What is the core focus of Mira Pharmaceuticals?

Mira Pharmaceuticals is focused on developing innovative therapies for neurological and neuropsychiatric disorders, primarily through its pioneering work on a novel oral ketamine analog and a marijuana analog.

What distinguishes Ketamir-2 from traditional ketamine?

Ketamir-2 features a selective mechanism that targets the NMDA receptor at the PCP-binding site with a lower affinity, enhancing safety by reducing common side effects and improving oral bioavailability and brain penetration.

What therapeutic areas are being addressed by Mira Pharma?

The company's research targets a range of conditions including neuropathic pain, treatment-resistant depression, PTSD, and cognitive decline associated with early-stage neurological disorders.

How does Mira Pharma position itself within the competitive landscape?

Mira Pharma differentiates itself by focusing on non-opioid treatments with cleaner pharmacological profiles, leveraging innovative drug delivery systems and preclinical evidence to address significant unmet clinical needs.

What is the significance of the IND application for Mira Pharma?

Submitting an IND application is a crucial step that enables the initiation of clinical trials. This process demonstrates the company's commitment to advancing its preclinical data into human studies and ultimately towards therapeutic approval.

What role does MIRA-55 play in the company’s pipeline?

MIRA-55 is the company’s novel oral pharmaceutical marijuana analog being investigated for the treatment of neuropathic pain, anxiety, and cognitive decline, offering an alternative therapeutic option with a robust safety profile.

How does the company ensure the safety of its drug candidates?

Mira Pharma conducts extensive preclinical safety studies under GLP conditions to evaluate toxicity, pharmacokinetics, and pharmacodynamics. This rigorous research underpins their confidence in moving forward with an IND submission and clinical trials.

What future clinical milestones are anticipated for Mira Pharma?

The company plans to initiate Phase I clinical trials to assess safety and pharmacokinetics, followed by proof-of-concept studies in targeted patient populations, paving the path for potential approval of their innovative therapies.
Mira Pharma

NASDAQ:MIRA

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MIRA Stock Data

19.71M
13.59M
23.68%
6.61%
4.26%
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