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MIAMI - MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a pre-clinical-stage pharmaceutical company, today announced new preclinical study results for Ketamir-2, its novel oral ketamine analog. The company is preparing to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) by the end of the year, which could permit human trials of Ketamir-2.
Ketamir-2 is being researched for the treatment of neurological and neuropsychiatric disorders, including depression, treatment-resistant depression (TRD), and post-traumatic stress disorder (PTSD). The substance has shown promise in preclinical studies for better oral absorption and brain penetration compared to traditional ketamine due to its non-interaction with the P-glycoprotein (P-gp) membrane protein.
The recent data focus on the potential benefits of Ketamir-2, such as improved patient compliance due to its oral administration format, which could eliminate the need for hospital visits required for intravenous ketamine treatments. Additionally, its ability to bypass P-gp may allow for better brain penetration and lower dosing, possibly leading to higher efficacy at reduced doses.
MIRA's ongoing research indicates that Ketamir-2 has an oral bioavailability prediction of around 80%, significantly higher than that of traditional ketamine. The analog has also demonstrated safety at high doses, effectiveness in anti-depressant and anxiolytic models, and no hyper-locomotor activity or interaction with the mu-opioid receptor, which could mean a lower risk of opioid-related side effects and dependency.
The company is expanding its research to include chemotherapy-induced depression and cancer-related neuropathic pain, and is exploring orphan drug designations for conditions like multiple sclerosis-induced depression and Huntington's disease-induced depression.
Erez Aminov, Chairman & CEO of MIRA Pharmaceuticals, expressed the company's commitment to transforming the treatment landscape for neurological and neuropsychiatric disorders, while Dr. Itzchak Angel, Chief Scientific Advisor, emphasized the potential of Ketamir-2 as a groundbreaking treatment.
MIRA also has another early-stage preclinical development program, MIRA-55, an oral pharmaceutical marijuana analog being investigated for neuropathic pain, anxiety, and cognitive decline.
The announcement is based on a press release statement, and it is important to note that Ketamir-2 and MIRA-55 are still in the preclinical phase with no certainty of progression through development or FDA approval.
In other recent news, Mira Pharmaceuticals is facing potential Nasdaq delisting due to its stock price remaining below the required threshold. The company has been granted a 180-day period to regain compliance.
To address this, Mira Pharmaceuticals is actively pursuing strategies and considering strategic partnerships. On the development front, Mira Pharmaceuticals is making progress with its investigational drugs, MIRA-55 and Ketamir-2. Notably, MIRA-55 has been cleared by the U.S. Drug Enforcement Administration for further development.
In executive news, the company's Chief Financial Officer, Michelle Yanez, has agreed to a reduced annual base salary, maintaining her role at Mira Pharmaceuticals while accommodating responsibilities at other companies. The company is also preparing for its first annual shareholder meeting.
In collaboration news, Mira Pharmaceuticals is 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 underscore Mira Pharmaceuticals' commitment to innovation and improving patient outcomes. However, 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.
InvestingPro Insights
As MIRA Pharmaceuticals advances its preclinical studies and moves towards submitting an IND application for Ketamir-2, investors are closely monitoring the company's financial health and market performance.
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 continues to fund its research and development activities. This is particularly important for a pre-clinical-stage company like MIRA, where cash reserves are crucial for sustaining operations before any product reaches the market.
Despite the innovative potential of Ketamir-2, MIRA has not been profitable over the last twelve months, with an operating income of -8.95M USD and a concerning return on assets of -587.64%. Moreover, the stock price has experienced a significant decline over the last year, with a 1 Year Price Total Return of -90.72%. This could be indicative of market skepticism about the company's ability to successfully bring its products to market or broader market trends affecting biotech stocks.
Investors interested in the biotech sector and companies like MIRA may find valuable insights through InvestingPro tips. The platform offers a comprehensive analysis of companies, including additional tips not mentioned here. For those looking to delve deeper into MIRA's financials and market prospects, InvestingPro lists 5 additional tips that could provide further guidance. To access these insights, investors can use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
While the preclinical results for Ketamir-2 are promising, investors should consider the company's financial position and market performance when evaluating its potential. The data provided by InvestingPro can help in making an informed decision about investing in MIRA Pharmaceuticals.
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