Zacks Small Cap Research – MIRA Makes Impressive Progress – Technologist

By Brad Sorensen, CFA

NASDAQ:MIRA

READ THE FULL MIRA RESEARCH REPORT

MIRA Pharmaceuticals (NASDAQ:MIRA) is a preclinical-stage pharmaceutical company focused on the development and commercialization of a new molecular synthetic cannabinoid analog for the treatment of adult patients with neuropathic pain as well as anxiety and cognitive decline typically associated with early-stage dementia. The company also acquired the rights to Ketamir, which, in layman’s terms, is a potential derivative of the antidepressant ketamine that has shown indications of having fewer side effects, working more rapidly, and having the opportunity to impact millions of patients that have not responded to other, existing treatments. We have written about the exciting preclinical results for Ketamir-2, the company’s novel oral ketamine analog, and the company just released further study results that, in our view, boost the potential for the treatment.

As previously discussed, Ketamir-2 is under investigation for its potential in treating neurological and neuropsychiatric disorders, including depression, treatment-resistant depression (TRD), and post-traumatic stress disorder (PTSD). We are pleased to see the company focus its attention on neuropathic pain to being with, which we believe will allow for a quicker and more efficient approval process.

Additionally, the company announced that it has completed the design of its Phase I clinical trial of Ketamir-2 for the treatment of neuropathic pain and is on track for its IND filing with the FDA in December 2024. The company expects Phase I trials to begin in early Q1 2025. The company notes the trial will assess safety, tolerability, and pharmacokinetics in humans, laying the groundwork for subsequent efficacy studies. We continue to be impressed by the speed and dedication of company management in getting this exciting treatment through the approval process so that patients can be helped as soon as possible and revenue can start to be recognized. As noted above, neuropathic pain is the primary initial focus but there are many other conditions that stand to benefit from Ketamir-2 and we are confident that the initial Phase I trial will help to inform future trials for other conditions.

We remain extremely positive on MIRA, and this announcement is yet another confirmation that the potential for MIRA’s treatments is large and growing. This announcement, in our view, helps to further validate the potential for MIRA therapies. The company has two potential groundbreaking therapies and is rightly focusing on the one with the potential to get to market the fastest—Ketamir-2, but also continuing to advance MIRA-55, which we have written extensively about, in the background. We urge investors to look at MIRA and suggest those with a modestly higher risk tolerance consider investing before MIRA announces more positive results or collaborations the stock really starts to move higher.

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