- On **October 15, 2025**, MIRA Pharmaceuticals, Inc. announced new **preclinical data** for its proprietary non-psychotropic marijuana analog, **Mira-55**.  **[1904286_0001493152-25-018141_form8-k.htm:1]** 
- The study demonstrated that **oral administration of Mira-55 normalized pain and significantly reduced inflammation**, outperforming injected morphine in an established animal model of chronic inflammatory pain.  **[1904286_0001493152-25-018141_form8-k.htm:1]** 
- This marks the first time inflammation was directly measured in the Mira-55 program, showing **superior pain normalization and direct anti-inflammatory effects** compared to morphine's partial and indirect reduction.  **[1904286_0001493152-25-018141_form8-k.htm:1]** 
- These findings support MIRA's plan to pursue an **Investigational New Drug (IND) application for chronic inflammatory pain**, reinforcing its position in the **$70 billion non-opioid pain market**.  **[1904286_0001493152-25-018141_form8-k.htm:1]**

MIRA Pharmaceuticals Announces Positive Preclinical Data for Mira-55

- **MIRA Pharmaceuticals, Inc. completed the acquisition of SKNY Pharmaceuticals, Inc. on September 29, 2025**, acquiring 100% of SKNY in exchange for restricted shares of MIRA's common stock.  **[1904286_0001493152-25-016168_ex10-1.htm:0]** **[1904286_0001493152-25-016168_form8-k.htm:1]** 
- As a condition to closing, SKNY contributed **$5 million in marketable securities** to MIRA, strengthening the Company’s balance sheet.  **[1904286_0001493152-25-016168_form8-k.htm:1]** 
- The acquisition expands MIRA's pipeline, positioning it as a multi-program biopharmaceutical developer with programs addressing high-value therapeutic areas, including **Ketamir-2** (Phase 1 for neuropathic pain), **MIRA-55** (oral THC analog for inflammatory pain), and **SKNY-1** (oral therapeutic for obesity and smoking cessation).  **[1904286_0001493152-25-016168_form8-k.htm:1]** 
- MIRA believes it has **regained compliance with Nasdaq's minimum $2,500,000 stockholders' equity rule** as of the date of the report, following the acquisition and other stock sales.  **[1904286_0001493152-25-016168_form8-k.htm:3]**

MIRA Pharmaceuticals Completes Acquisition of SKNY Pharmaceuticals

- MIRA Pharmaceuticals, Inc. announced **positive results** from a proof-of-concept validation study for its oral drug candidate, **Ketamir-2**, in an animal model of post-traumatic stress disorder (PTSD) on **September 15, 2025**.  **[1904286_0001493152-25-013459_form8-k.htm:1]** 
- The study demonstrated that Ketamir-2 treatment was associated with a **reversal of PTSD-like behaviors** (such as increased despair and immobility) in stressed animals, returning them to levels observed in non-stressed animals.  **[1904286_0001493152-25-013459_form8-k.htm:1]** 
- Ketamir-2 is a **proprietary, orally bioavailable new molecular entity** designed to provide the therapeutic efficacy of ketamine while minimizing dissociative and central nervous system side effects, and it has been determined **not to be a controlled substance** by the U.S. Drug Enforcement Administration.  **[1904286_0001493152-25-013459_form8-k.htm:1]** 
- A larger follow-on PTSD study is currently ongoing, and Ketamir-2 is also being evaluated in an ongoing Phase 1 clinical trial for neuropathic pain, where it has shown a **favorable safety profile** to date.  **[1904286_0001493152-25-013459_form8-k.htm:1]**

MIRA PHARMACEUTICALS (MIRA)