By Brad Sorensen, CFA

NASDAQ:MIRA

READ THE FULL MIRA RESEARCH REPORT

MIRA Pharmaceuticals (NASDAQ:MIRA) is a clinical-stage pharmaceutical company that focuses 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 announced the beginning of clinical trials, illustrating further important advancement in the approval process.

Ketamir-2 took a major step forward with the company announcing that it has received authorization from the Israeli Ministry of Health for its Phase I clinical trial for the treatment of neuropathic pain with initiation scheduled to begin in Q1 and conclude by Q4 2025, with the company believing it will be able to start a Phase 2 trial by the end of the year.

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 with the company’s decision to focus its attention on neuropathic pain to begin with, which we believe will allow for a quicker and more efficient approval process—a belief which we believe is justified by today’s announcement.

Also supporting that belief is the announcement by MIRA that a preclinical study, which was conducted using a nerve ligation-induced neuropathy model in female rats, showed that low doses of Ketamir-2 provided “significant pain relief” by day 15. Even more encouraging for the potential approval and commercialization of the drug was the announcement that by day 22 of the study, Ketamir-2 provided up to 112% and 70% greater relief than two leading neuropathic pain relief drugs—Pregabalin and Gabapentin, respectively. Sales of these two approved treatments are expected, according to research cited by the company, to reach a combined $7 billion in annual sales by 2033.

As a reminder, the existing treatments also have side effects such as drowsiness, dizziness, cognitive impairment, and weight gain, along with the potential for misuse and withdrawal upon discontinuation.

In previous tests, Ketamir-2 has shown none of these side effects and is a non-opioid and has no known risk of dependence.

We remain extremely positive on MIRA, and this announcement is yet further confirmation that company management is on the right track to realize the potential of Ketamir-2. 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 and the stock really starts to move higher.

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