MIAMI - MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA), a biotech firm at the pre-clinical stage, announced today that its investigational compound Ketamir-2 has shown promise in pre-clinical studies for the treatment of major mental health disorders. The company is working towards filing an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) by the end of the year, which could lead to human trials.
Ketamir-2 is being studied as a potential treatment for treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDSI), and post-traumatic stress disorder (PTSD). The latest research has focused on the compound's stability in blood, its metabolic profile, and how it binds to blood proteins—factors critical to determining its safety and pharmacological potential.
According to the studies, Ketamir-2 has demonstrated excellent stability in human blood and an optimal binding to blood proteins, suggesting that it could be effectively delivered throughout the body. The metabolic profile indicates that Ketamir-2 could be metabolized safely with fewer interactions with other medications, a common concern for both doctors and patients.
Initial toxicology assessments have also provided a favorable safety profile for Ketamir-2, which is crucial for its advancement through regulatory review and into clinical trials. The company’s Chairman & CEO, Erez Aminov, highlighted the financial impact of medication-treated major depressive disorder in the U.S., which stands at $92.7 billion annually, with treatment-resistant depression accounting for nearly half of this cost.
MIRA Pharmaceuticals holds exclusive rights for Ketamir-2 in the U.S., Canada, and Mexico. The company's other investigational product, MIRA-55, is aimed at treating anxiety and cognitive decline associated with early-stage dementia.
The information in this article is based on a press release statement from MIRA Pharmaceuticals, Inc.
InvestingPro Insights
In the midst of promising developments for its investigational compound Ketamir-2, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) presents a complex financial picture. According to InvestingPro real-time data, the company holds a market capitalization of $15.96 million USD, indicative of its small-cap status in the biotech industry. This size could imply a higher risk-reward ratio for potential investors, given the early stage of the company's product development.
Notably, MIRA's stock trades with high price volatility, an InvestingPro Tip that correlates with the company's recent pre-clinical achievements and future FDA filing aspirations. The stock's six-month price total return has plummeted by -76.87%, reflecting the inherent risks of investing in pre-clinical stage biotech firms. Additionally, the company's price stands at 13.53% of its 52-week high, potentially offering a discounted entry point for investors who believe in the long-term prospects of Ketamir-2.
Financially, MIRA is navigating challenging waters with a negative P/E ratio of -1.33 for the last twelve months as of Q4 2023, reinforcing the InvestingPro Tip that the company has not been profitable over this period. With an operating income of -$8.53 million USD for the same timeframe, the financial metrics underscore the high stakes of the company's clinical developments.
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