Zacks Small Cap Research – MIRA Making Strides Toward Breakthrough Treatment – 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. Most of us have heard about the purported benefits of cannabis (marijuana) in easing pain for sufferers who have had no other valid alternative as well as ease anxiety that people may be experiencing in times of high stress.

There are widely known potential negatives associated with using cannabis, or specifically THC, which is the major psychoactive component in marijuana. One of the major problems is the dosing of an unregulated treatment that can vary greatly in potency, where using too little can mean the potential positive impact is never realized, while using too much can actually increase anxiety and irritability. Additionally, THC consumption can impair cognitive function, leading to decreased attention, memory problems, and reduced problem-solving abilities. It may also exacerbate mental health issues, particularly in individuals predisposed to conditions like anxiety, schizophrenia and bipolar disorder. Frequent use can lead to cannabis use disorder, characterized by withdrawal symptoms, cravings, and difficulty quitting, which can have a significant impact on one’s daily life. Additionally, smoking or vaping THC can harm lung health and may increase the risk of respiratory issues. Furthermore, THC can impair motor coordination and judgment, increasing the risk of accidents and injuries when driving or operating machinery.

In response to these problems with traditional marijuana, MIRA is developing a compound that offers the benefits of cannabis while minimizing the potential negative side effects. That might sound too good to be true, but we are encouraged by the initial test results we’ve seen and impressed by the leadership and their passion for finding a solution to a problem plaguing a vast number of Americans. MIRA1a was the molecule that we reported the very positive preclinical results on in our last report. Recently, however, the company discovered that the actual molecule that had undergone the testing was a novel and improved version of the molecule, which is known as MIRA-55. The company has applied for a patent on this new compound, and it is this molecule that the company will be moving forward in the FDA approval process.

Importantly, and for this to be a viable project, the company received great news on November 28, 2022, when the U.S. Drug Enforcement Agency (DEA) confirmed in writing that it conducted a scientific review of the chemical structure of MIRA-55 in accordance with the definitions within the Controlled Substances Act (CSA) and its implementing regulations and determined that MIRA-55 is not a controlled substance or listed chemical. This means that MIRA-55 can go through the traditional FDA approval process and be used by patients, if approved, without the logistical and financial complications of working with a Schedule 1 drug —a potential exciting and extremely beneficial breakthrough and a reason, in our view for investors to take a hard look at MIRA before it gets too far along in the process and more investors push up the price.

MIRA’s plans for MIRA-55 potential benefits to the public begin with continuing pre-clinical testing, which we expect will yield positive results and MIRA expects to be completed in 2024. The updated plan is for the first IND application submission related to MIRA-55 for the treatment of elderly patients suffering from anxiety with some cognitive decline to occur by the end of 2Q2025, with a Phase I trial initiated 30-days post IND submission, if allowed by the FDA.

MIRA-55 is in addition to a ketamine analog the company has exclusive rights to known as Ketamir-2. As a reminder, Ketamir-2 is a new chemical entity that is designed to have the same rapid antidepressant response, but with improved bioavailability, which would potentially allow the pill to be administered at home. Additionally, the compound may have decreased side effects and potential for abuse—which we’ll find out more about as testing continues. The company is currently in the manufacturing scaling up phase, which will be followed by IND-enabling research.

We believe these timelines, and the potential for two successful treatments, makes the next few months an opportune time for investors to look at investing in MIRA. Post IPO and before more positive test results come out represent a sweet spot for investors who believe that the science story told above will lead to positive human trial results, at which point the stock will likely move sharply higher.

Finally, the company released its annual report, which confirmed the progress the MIRA is making toward potential breakthrough therapies. Importantly, the cash balance at the end of 2023 stood at just over $4.6 million, which the company notes is expected to be sufficient to sustain operations into 4Q2024. For a preclinical company at this stage, more funding being needed is not a surprise, and the current runway the company has is encouraging and gives us one more reason to suggest investors take a look at MIRA.

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