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.
The company has shifted its primary focus to getting Ketamir through the FDA approval process, which we believe is the right way to go given the potential Ketamir has shown, with the company having a goal of having an IND submission to the FDA by year end. Giving us more confidence in this focus was the recent announcement that Dr. Itzchak Angel has joined the company as its Chief Scientific Advisor.
Dr. Angel comes to MIRA with over 40 years of preclinical, clinical and regulatory experience, qualifications that are highly valuable as MIRA navigated Ketamir through the FDA approval process. When Dr. Angel was with Synthelabo, which was later acquired by Sanofi-Aventis, he was a vital part of advancing multiple drugs from the conception point to IND applications and clinical trials—including Litoxetine, which is a treatment for depression. MIRA also notes that Dr. Angel contributed heavily to the development and marketing of Mizollen, Xatral, and Ambien.
We believe this is a deal that provides a great addition for MIRA. Ketamir is at the beginning of the approval process and initial tests that we’ve seen have proved quite promising. Having someone like Dr. Angel with vast experience of shepherding treatments through the gauntlet needed to be completed is invaluable. Already, we’ve heard from the company that Dr. Angel has implemented a new, synthetic approach to manufacturing Ketamir, which involves more cost-effective materials, indicating that in addition to the experience, Dr. Angel is bringing a cost control discipline to MIRA that is lacking in many clinical stage companies.
There are currently roughly 30 antidepressants available to the public, but 33% of patients receive no relief from any of these treatment options, while, for the patients that the treatments do work for, the time to take effect can be lengthy. Additionally, one of the more popular treatments goes by the name Spravato, which is an esketamine marketed by Johnson and Johnson. Although the treatment is given by a nasal spray, patients are required to administer the medication at a certified treatment center where the patient can be observed for at least two hours in order to ensure no dangerous side effects begin. The FDA requires this REMS (risk evaluation and mitigation strategies) due to potential side effects such as sedation and dissociation, while also being concerned about the potential for abuse of the Schedule III substance. Despite these hurdles, sales for 2023 of Spravato are expected to be around $600 million. It’s highly unlikely that Ketamir will face these same hurdles as the company announced that they had received a decision on Ketamir from the Drug Enforcement Agency: “The Drug Enforcement Administration (DEA) conducted a scientific review of the chemical structures of these substances in accordance with the definitions within the CSA and its implementing regulations. Based on this review, DEA determined that Ketamir-1 and Ketamir-2 are not controlled substances or listed chemicals under the CSA.” That decision will make Ketamir, if and when it is approved by the FDA, much easier to obtain and use for patients. Additionally, being able to ingest Ketamir orally provides enormous benefits for ease of use for patients and has the potential to provide relief from crippling depression without going through a time intensive, onerous process.
There is still a long FDA process to go through, but in initial testing, Ketamir has been shown to have fewer side effects due to its design that avoids impacting the opiate receptor. Testing has also shown better bioavailability, meaning that the treatment gets into the bloodstream in a more efficient way through better absorption in the intestine.
The possibilities of Ketamir are numerous as it moves through the approval process. Recently, ketamine has shown promise in treating such conditions as those related to Parkinson’s disease, certain types of cancer and postpartum depression. Given the similarities to ketamine that Ketamir has, we believe this provides excellent opportunity for MIRA and for patients due to the much easier, more accessible, and affordable aspects of Ketamir.
The company also released its 1Q2024 results that showed a good cash position of over $3.5 million and an increase in research costs as part of the push to get Ketamir submitted for approval.
We remain extremely positive on MIRA, which has another drug with great potential that we highlighted in the last report but is on the back burner for new, and its prospects for the future. The company has two potential groundbreaking therapies and is rightly focusing on the one with the potential to get to market the fastest. We urge investors to look at MIRA and suggest those with a modestly higher risk tolerance consider investing before MIRA announces more positive results the stock really starts to move higher.
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