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 beginning of clinical trials, illustrating further important advancement in the approval process.

In addition to all of this, the company just announced that it has signed a binding letter of intent to acquire SKNY Pharmaceuticals, which has a preclinical-stage oral drug candidate for weight loss and smoking cessation. The transaction also involves SKNY contributing $5 million to MIRA in a capital infusion. This is a promising development, with the obesity market estimated at over $150 billion within the next decade (Reuters), while the smoking cessation market is expected to reach nearly $51 billion by 2030 (Grand View Research).

Briefly, the drug candidate being acquired, according to the company, is designed to interact with cannabinoid receptors that have been demonstrated for their role in appetite, metabolism and energy balance regulation, with a similar method of action impacting nicotine dependence.

Obviously, more testing will have to be done and we’re excited to see the results of those tests, but this deal is another example of MIRA management looking to add tremendous value for shareholders by greatly expanding the pipeline, while also increasing capital in a very shareholder friendly way.

Another potentially market expanding preclinical announcement was recently made when the company revealed that it has successfully developed Ketamir-2 into a topical treatment for neuropathic and inflammatory pain. This opens up an additional method of treatment and customer base that offers great potential and we are looking forward to the additional testing the company is planning on. Company management noted that the topical formulation is designed for slow release, which enables targeted pain relief, while minimizing systemic exposure.

Ketamir-2 took a major step forward earlier this year 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.

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 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.

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