MIAMI - MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a company specializing in treatments for neurological and psychiatric disorders, has announced its intention to focus on neuropathic pain as the primary indication for its new drug candidate, Ketamir-2. The firm has engaged with the U.S. Food and Drug Administration (FDA) for a pre-IND meeting, expected to take place in November 2024, and aims to submit an Investigational New Drug (IND) application by the year's end.
Neuropathic pain, characterized by sensations such as burning and "pins and needles," affects millions and is often inadequately managed by current treatments, which can have severe side effects and addiction risks. The North American market for these treatments is projected to reach $5.2 billion by 2030, indicating a significant growth opportunity.
Ketamir-2, an oral ketamine analog, is designed to offer better efficacy and safety compared to existing medications. It is engineered to target the NMDA receptor with fewer side effects and is not classified as an opioid, potentially making it more accessible for clinical use. Preclinical studies suggest that Ketamir-2 could provide effective pain relief without sedation, positioning it as a potential leader in pain management.
MIRA's Chairman and CEO, Erez Aminov, expressed confidence in Ketamir-2's ability to meet the growing needs of the neuropathic pain market. The company's Chief Scientific Advisor, Dr. Angel, highlighted the progress of IND-enabling studies and the broad potential of Ketamir-2 to treat neuropathic pain and depression.
MIRA Pharmaceuticals, holding exclusive rights for Ketamir-2 in the U.S., Canada, and Mexico, is also investigating another candidate, MIRA-55, for anxiety and cognitive decline. Both drugs have been determined by the DEA to not be controlled substances, which could streamline their path to market.
This announcement is based on a press release statement and includes forward-looking statements regarding the anticipated benefits and development timeline of Ketamir-2. These statements are subject to risks and uncertainties that could cause actual results to differ. MIRA's filings with the SEC provide additional information on these risks.
In other recent news, MIRA Pharmaceuticals is making strides in the development of its drug candidates, Ketamir-2 and MIRA-55. The company is on track to submit an Investigational New Drug (IND) application by year-end, following recent scientific and strategic advancements. MIRA Pharmaceuticals has also reported promising preclinical data for Ketamir-2 and its primary metabolite Nor-Ketamir-2, demonstrating nearly 100% oral bioavailability and improved brain penetration.
Ascendiant Capital has initiated coverage on MIRA Pharmaceuticals with a 'Buy' rating, citing the company's innovative approach in developing neuroscience programs. The company has also regained compliance with the Nasdaq's minimum bid price requirement, ensuring its continued listing on the Nasdaq Capital Market.
In terms of company operations, MIRA Pharmaceuticals' Chief Financial Officer, Michelle Yanez, has agreed to a reduced annual base salary, continuing her role at MIRA despite the pay cut. 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 recent developments highlight MIRA Pharmaceuticals' commitment to advancing its drug candidates and maintaining regulatory standards.
InvestingPro Insights
As MIRA Pharmaceuticals gears up for a pivotal phase in the development of its drug candidate, Ketamir-2, the company's financial health and stock performance are key factors for investors to consider. According to InvestingPro data, MIRA holds a market capitalization of $19.07 million, reflecting its position in the biotech industry. Notably, the company's stock has experienced significant volatility recently, with a one-week price total return of -24.12% and a one-month price total return of -38.57%. However, looking at a slightly longer horizon, the three-month price total return shows a strong rebound of 72.0%.
InvestingPro Tips highlight that MIRA's stock has been identified as being in oversold territory based on the Relative Strength Index (RSI), which could suggest a potential turning point for investors watching the stock's technical indicators. Additionally, the company's balance sheet holds more cash than debt, providing a degree of financial stability as it moves forward with regulatory engagements and clinical trials.
For investors seeking a deeper dive into MIRA's financial performance and stock analysis, InvestingPro offers an array of additional tips. Currently, there are 12 more InvestingPro Tips available, which can provide further insights into the company's valuation, such as its high Price / Book multiple of 8.59, and its prospects, including the lack of profitability over the last twelve months and the absence of dividend payouts to shareholders.
With the next earnings date set for November 27, 2024, stakeholders and potential investors will be keenly watching for updates on the IND application and any further developments that could impact MIRA's market valuation and the InvestingPro Fair Value estimate of $1.72 USD.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.