MIRA Pharmaceuticals Provides Corporate Update
- Partnership with Pharmaseed for pre-clinical studies on Ketamir
- Potential to transform the treatment of depression and PTSD
- Ketamir's oral bioavailability predicted to be approximately 80%
- Valuation analysis forecasts average annual sales of $3 billion by 2035
- None.
Insights
The collaboration between MIRA Pharmaceuticals and Pharmaseed to conduct pre-clinical studies on Ketamir represents a significant step in addressing the unmet needs in the treatment of Major Depressive Disorder (MDD) and Post-Traumatic Stress Disorder (PTSD). The focus on improving oral bioavailability is particularly noteworthy as it could enhance patient compliance and accessibility, potentially disrupting the current market for antidepressants. The move towards an Investigational New Drug (IND) application signals MIRA's commitment to advancing their product pipeline and could have substantial implications for their future revenue streams, especially considering the projected market sizes for MDD and PTSD treatments.
Given the high prevalence of MDD and the economic burden associated with medication-treated cases, as well as the growing market for PTSD treatments, the development of Ketamir could represent a significant commercial opportunity for MIRA. The forecast by IQVIA suggests a substantial market potential, which could positively influence MIRA's stock value if the pre-clinical trials and subsequent phases of clinical trials prove successful. However, it is crucial to note that the pharmaceutical industry is highly regulated and the success of new drugs is uncertain until they have passed through rigorous clinical trials and received FDA approval.
From a market perspective, the strategic partnership with a GLP-certified CRO like Pharmaseed enhances MIRA's credibility and could positively influence investor confidence. Pharmaseed's specialized expertise in neurological disorders adds significant value to the research process, potentially increasing the likelihood of successful pre-clinical outcomes. The anticipated ease of administration and fewer side effects of Ketamir compared to existing treatments could lead to a competitive advantage in the antidepressant market, which is currently dominated by drugs requiring clinical supervision or those with significant side effects.
The projected valuation of Ketamir by 2035 indicates a strong revenue potential that could attract further investments and partnerships. However, investors should consider the inherent risks of drug development, including the possibility of unsuccessful trials or regulatory challenges. The long-term impact on MIRA's financials will depend on the successful progression through clinical trials and eventual market adoption, which is influenced by factors such as drug efficacy, safety, cost and competition from alternative treatments.
Investors should closely monitor MIRA's progress towards the IND application and the outcomes of the pre-clinical studies. Positive results could lead to a surge in investor interest and potentially an increase in MIRA's market capitalization. The initiation of a Toxicology program in collaboration with Frontage Laboratories is another critical factor, as it addresses safety concerns that are pivotal for regulatory approval and market acceptance.
It is important to analyze how the development of Ketamir fits into MIRA's overall financial strategy and portfolio diversification. The heavy investment in R&D for Ketamir suggests a long-term vision for growth, but it also represents a significant allocation of resources that could impact financial stability if not managed carefully. The potential for Ketamir to generate substantial revenue is promising, yet the actual financial impact will only materialize after successful commercialization, which is several years away. Investors should weigh the potential long-term benefits against the immediate costs and risks associated with the development of new pharmaceuticals.
Announces Research Collaboration with Pharmaseed to Conduct Pre-Clinical Studies on the Use of Ketamir for Patients with Major Depressive Disorder (MDD) and Post-Traumatic Stress Disorder (PTSD)
Studies will Investigate Antidepressant Properties of Ketamir to Position for Initial IND Application in 2024
The Company has partnered with Pharmaseed Ltd., a clinical research organization ("CRO"), to research and evaluate Ketamir-2 ("Ketamir"), a novel ketamine analog with improved gastrointestinal bioavailability under investigation to potentially be an orally delivered ultra-rapid antidepressant.
Pharmaseed is
Ketamir is a novel compound designed to address the challenges presented by major depressive disorder (MDD), a significant health concern affecting approximately 18 million people in the
Moreover, Ketamir is also under investigation for treating Post Traumatic Stress Disorder (PTSD), a market that is projected to reach
Additionally, a valuation analysis conducted by IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, forecasts that by 2035, Ketamir could generate average annual sales of
"We are privileged to be working with Pharmaseed to evaluate our novel ketamine analog that may have the potential to transform the treatment of depression and PTSD," said Erez Aminov, Chief Executive Officer of MIRA Pharmaceuticals. "Pharmaseed is an ideal pre-clinical research partner with their experience in a wide range of neurological disorders including depression and anxiety. Results from recent studies indicate Ketamir's oral bioavailability is predicted to be approximately
Itschak Lamensdorf, PhD, Founder and CEO of Pharmaseed, added, "We're enthusiastic about joining forces with MIRA to develop their groundbreaking pipeline for CNS disorders, a field with critical unmet needs. At Pharmaseed, leveraging our expertise to transition ideas into early clinical stages is fundamental to our mission, and this collaboration is a testament to that commitment."
New Research Coverage
MIRA is honored to announce that Kingswood Capital Partners, LLC, a respected and reputable entity in the financial sector, has initiated research coverage on the Company's publicly traded stock with a Buy rating and a
About Pharmaseed Ltd.
Pharmaseed is a GLP-certified contract research organization (CRO) providing pre-clinical, early clinical and consulting services for medical device, biotechnology and pharmaceutical companies. Pharmaseed also provides pre-formulation services for small and medium-size start-up companies as well as companies in the idea and feasibility stages. For more information, visit https://www.pharmaseedltd.com/.
About Kingswood Capital Partners, LLC
Kingswood Capital Partners, LLC, part of the Kingswood Group, is a network of wealth management firms that includes an SEC-registered RIA and a FINRA-licensed broker-dealer, offering comprehensive wealth management and business-building services, designed specifically for the independent financial advisor.
1 BMC Psychiatry, PMID: 32703173
2 The Journal of Clinical Psychiatry, PMID: 33989464
3 Allied Market Research: Post-Traumatic Stress Disorder Treatment Market Research, 2031
4 IQVIA Analysis
About MIRA Pharmaceuticals, Inc.
MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. The Company's novel oral pharmaceutical marijuana, MIRA1a, is currently under investigation for treating adult patients suffering from anxiety and cognitive decline, often associated with early-stage dementia. MIRA1a, if approved by the FDA, could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders.
MIRA has an exclusive licensing agreement for Ketamir-2, a unique, patent pending novel oral ketamine analog under investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression (TRD) and major depressive disorder with suicidal ideation (MDSI).
The
Additional information about the Company is available at: www.mirapharmaceuticals.com.
Forward-Looking Statements
This press release may contain forward-looking statements about MIRA Pharmaceuticals, Inc. ("MIRA," "we," "us," or "our"). In some cases, you can identify forward-looking statements by terminology such as "anticipate,' "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will" or "would," or the negative of these terms or other comparable terminology. These forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including risks and uncertainties regarding our ability to develop and obtain regulatory approval for our product candidates, Ketamir-2 and MIRA1a. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause our actual results, levels of activity, performance or achievements of and those of our industry to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Some of these risks and uncertainties are identified in our Registration Statement on Form S-1 filed with the SEC (File No. 333-273024) and in our other filings with the SEC, which are available at www.sec.gov. You should not place undue reliance on any forward-looking statement. We undertake no obligation to update or revise publicly any of the forward-looking statements after the date hereof to conform the statements to actual results or changed expectations except as required by law.
General Note
This press release discusses product candidates that are in early stage pre-clinical development and have not yet been approved for marketing by the
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SOURCE MIRA Pharmaceuticals, Inc.
FAQ
What is MIRA Pharmaceuticals, Inc. collaborating on with Pharmaseed?
What is the purpose of the research collaboration between MIRA Pharmaceuticals, Inc. and Pharmaseed?
What are the potential benefits of Ketamir for patients with MDD and PTSD?
What is the predicted oral bioavailability of Ketamir?
What are the forecasted average annual sales for Ketamir by 2035?
