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MIRA Enrolls Patients Amid Rapid Progress

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By Brad Sorensen, CFA

NASDAQ:MIRA

READ THE FULL MIRA RESEARCH REPORT

MIRA Pharmaceuticals (NASDAQ:MIRA) is a clinical-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 announced the enrollment of the first subjects in the Phase I clinical trial, illustrating further important advancement in the approval process.

This announcement is crucial to the advancement of Ketamir-2 and seeks to build on the compelling evidence we’ve discussed before, which should be a huge advance for patience and suggest a potential inflection point for the stock.

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.

Finally, the company released its annual report that showed MIRA management continuing to be prudent about its spending and manage its cash position well without the dilutive impact on shareholders we often see and expect with companies at this stage.

We remain extremely positive on MIRA, and this announcement is yet further confirmation that company management is focused on bringing relief to patients and providing value to shareholders. The company now has three 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.