MIRA Pharmaceuticals advances novel pain treatment

MIAMI - MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a company specializing in the development of therapies for neurological and neuropsychiatric disorders, has announced progress in its clinical development plan for a new oral ketamine analog. The drug, Ketamir-2, is being developed to treat neuropathic pain and potentially other neurological conditions.

The company has started drug product development in collaboration with Formulex, focusing on a spray-dry based granulation process to enhance oral bioavailability. This partnership aims to optimize the formulation for patient convenience.

MIRA is on schedule for its Investigational New Drug (IND) filing with the U.S. Food and Drug Administration (FDA) in December 2024. The company is currently conducting Good Laboratory Practice (GLP) toxicological studies, which are crucial for the IND application.

The pharmaceutical firm is prioritizing early clinical efficacy signals, with Phase I/II study designs intended to demonstrate clinical activity by 2025. Preclinical studies in animal models are also underway, targeting Diabetic Neuropathy and Cancer-Induced Neuropathy, with results expected by late 2024.

Erez Aminov, Chairman and CEO of MIRA, emphasized the company's focus on demonstrating meaningful clinical benefits in specific patient populations. The Phase I clinical trial, set to begin in early Q1 2025, will assess safety, tolerability, and pharmacokinetics.

MIRA has also strengthened its clinical and regulatory strategy by appointing an experienced consultant with expertise in FDA regulatory bodies. This strategic move is aimed at ensuring high standards in clinical development and regulatory compliance.

Looking ahead, MIRA is exploring additional indications in mental health, including Major Depressive Disorder with Suicidal Ideation, Treatment-Resistant Depression, and Post-Traumatic Stress Disorder, with the potential to initiate a depression IND as early as next year.

MIRA Pharmaceuticals holds exclusive rights for Ketamir-2 in the U.S., Canada, and Mexico. The company is also investigating MIRA-55, an oral pharmaceutical marijuana analog for treating anxiety and cognitive decline associated with early-stage dementia.

The information in this article is based on a press release statement.

In other recent news, MIRA Pharmaceuticals has made significant strides in the development and regulatory preparation of its drug candidates, Ketamir-2 and MIRA-55. The company expects to submit an Investigational New Drug (IND) application by the end of this year, following promising preclinical data for Ketamir-2 and its primary metabolite, Nor-Ketamir-2. Notably, Ascendiant Capital has initiated coverage on MIRA Pharmaceuticals with a 'Buy' rating, acknowledging the company's innovative approach in developing neuroscience programs.

On the corporate front, MIRA Pharmaceuticals' Chief Financial Officer, Michelle Yanez, has agreed to a reduced annual base salary, demonstrating her continued commitment to the company. Furthermore, MIRA Pharmaceuticals has successfully regained compliance with the Nasdaq's minimum bid price requirement, ensuring its continued listing on the Nasdaq Capital Market.

The company is also in advanced discussions with Memorial Sloan Kettering Cancer Center to initiate a preclinical study on Ketamir-2 for cancer pain and depression treatment. These developments underscore MIRA Pharmaceuticals' dedication to advancing its drug candidates and maintaining regulatory standards.

InvestingPro Insights

As MIRA Pharmaceuticals forges ahead with its clinical development plan, the financial health and market performance of the company provide additional context for investors. According to InvestingPro, MIRA holds more cash than debt on its balance sheet, which is a positive sign for the company's financial stability as it invests in research and development. Additionally, the company's liquid assets exceed its short-term obligations, suggesting that MIRA is well-positioned to manage its immediate financial needs.

However, InvestingPro data indicates that the stock has been subject to high price volatility, which could be a concern for risk-averse investors. The stock has also experienced a significant price fall over the last year, with a 70.23% drop in the one-year price total return as of late 2024. Moreover, the company is trading at a high Price / Book multiple of 8.73, which may suggest that the stock is currently overvalued relative to its book value.

Investors should be aware that analysts do not expect MIRA to be profitable this year, and the company has not been profitable over the last twelve months. These factors, combined with the company's ongoing investments in drug development, could influence its stock performance in the near term. For those interested in a deeper dive, there are additional InvestingPro Tips available at: https://www.investing.com/pro/MIRA.

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