Mira Pharmaceuticals, Inc., a Florida-based pharmaceutical company specializing in the development of pharmaceutical preparations, is confronting the risk of delisting from the Nasdaq Capital Market after its stock price remained below the required $1.00 threshold for 30 consecutive business days. The company, which trades under the ticker symbol NASDAQ:MIRA, was notified by Nasdaq on Monday that it no longer complies with the minimum bid price requirement.
The current situation does not immediately affect Mira Pharmaceuticals' listing status, as the company has been granted a 180-day period until January 6, 2025, to regain compliance. To achieve this, the company's closing bid price must be at or above $1.00 for at least 10 consecutive business days before the deadline.
Mira Pharmaceuticals is actively pursuing strategies to address the issue and enhance shareholder value. The company is on track to submit an Investigational New Drug (IND) application for Ketamir-2, a novel ketamine-analog compound, to the U.S. Food and Drug Administration (FDA) by the end of 2024. Additionally, preparations are underway to initiate human clinical trials for Ketamir-2 in early 2025, pending FDA approval.
Furthermore, the company has reported consistent positive preclinical results for its compound MIRA-55, aimed at treating anxiety and cognitive decline associated with early-stage dementia. These findings suggest that MIRA-55 has improved efficacy and a better safety profile compared to THC, the main psychoactive component of marijuana.
In response to the delisting notice, Mira Pharmaceuticals is considering strategic partnerships to de-risk its clinical and regulatory pathway and is enhancing investor relations efforts to increase visibility among potential investors.
The company has the option to request an additional 180-day grace period to regain compliance if it meets certain conditions. However, if compliance is not achieved within the allotted time frames, or if the company fails to meet other Nasdaq listing requirements, its common stock may be delisted. Mira Pharmaceuticals has the right to appeal any delisting determination, with its stock remaining listed during the appeal process.
This press release statement contains forward-looking statements, and the company cautions that actual results could materially differ from those anticipated. Mira Pharmaceuticals has not committed to updating forward-looking statements as circumstances change.
In other recent news, MIRA Pharmaceuticals has seen significant developments. The company's Chief Financial Officer, Michelle Yanez, agreed to a reduced annual base salary to accommodate her responsibilities at Telomir Pharmaceuticals and other companies. Despite this change, she will continue her role at MIRA Pharmaceuticals. The company also announced its first annual shareholder meeting, set for September 2024.
In the realm of drug development, MIRA Pharmaceuticals has made strides with its investigational drugs, MIRA-55 and Ketamir-2. The U.S. Drug Enforcement Administration (DEA) recently cleared MIRA-55 for further development, a crucial step as the drug is being researched for neuropathic pain, anxiety, and early-stage dementia treatment. MIRA-55's clearance signifies a regulatory advantage over marijuana, simplifying the research and development processes.
MIRA Pharmaceuticals is also advancing its preclinical studies on Ketamir-2, an oral ketamine analog being evaluated for severe post-traumatic stress disorder (PTSD), depression, and neuropathic pain. The company is in advanced discussions with Memorial Sloan Kettering Cancer Center to initiate a preclinical study on Ketamir-2 for cancer pain and depression treatment.
It's important to note that both MIRA-55 and Ketamir-2 are still in early-stage pre-clinical development and have not yet received FDA approval for marketing. These recent developments underscore MIRA Pharmaceuticals' commitment to innovation and improving patient outcomes.
InvestingPro Insights
In light of Mira Pharmaceuticals' current challenges with Nasdaq listing requirements, several metrics from InvestingPro provide a deeper understanding of the company's financial position. With a market capitalization of just $8.87M, the company holds more cash than debt, suggesting a degree of financial stability despite its small size. However, Mira Pharmaceuticals has struggled with profitability, as evidenced by its negative earnings per share (EPS) of -$0.65 for the last twelve months as of Q1 2024. Its operating income also reflects these challenges, with an adjusted figure of -$8.95M for the same period.
InvestingPro Tips highlight that while Mira Pharmaceuticals has more liquid assets than short-term obligations, the company's gross profit margins are weak, and it has not been profitable over the last twelve months. Additionally, the stock price has experienced a significant downturn over the past year, with a 91.91% drop in the one-year total return as of the most recent data. These factors are crucial for investors to consider when evaluating the potential risks and rewards associated with the stock.
For investors seeking more comprehensive analysis, additional InvestingPro Tips can be found at https://www.investing.com/pro/MIRA. These tips may offer valuable insights into the company's performance and prospects. Interested investors can also use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, accessing even more detailed information and investment guidance.
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