MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a pre-clinical-stage pharmaceutical company that has firmly positioned itself at the forefront of developing innovative therapies for a broad range of neurologic and neuropsychiatric disorders. With a focus on two promising neuroscience programs, the company is poised to potentially reshape the landscape of treatment options in areas of significant unmet medical need.
Company Background
Founded in 2020 and headquartered in Miami, Florida, MIRA Pharmaceuticals has quickly emerged as a promising player in the pharmaceutical industry. The company's journey began with the exclusive licensing of Ketamir-2, a novel, patent-pending oral ketamine analog, and MIRA-55, a proprietary oral pharmaceutical marijuana molecule, both of which are undergoing pre-clinical investigations. MIRA Pharmaceuticals was incorporated under the laws of the State of Florida in September 2020 and commenced substantive operations, including its pharmaceutical development program, in late 2020.
In 2021, the company financed its operations through the sale of common stock in a private placement. During this time, MIRA Pharmaceuticals was primarily engaged in developing MIRA-55 and sustained substantial losses as it progressed its pharmaceutical development activities. The following year, in 2022, the company continued to finance its operations through additional sales of common stock. It also entered into a promissory note and loan agreement with a major shareholder, Bay Shore Trust, to help fund its development efforts. However, the company continued to face challenges and incurred significant losses as it pushed forward with its pre-clinical programs.
A significant milestone was reached in August 2023 when MIRA Pharmaceuticals completed its initial public offering, providing additional capital to support the advancement of its two lead drug candidates. This achievement came after the company had faced several obstacles, including the discovery in early 2024 that the pre-clinical studies it had conducted were actually performed on an improved version of its MIRA-55 compound, which it named MIRA-55.
Drug Development Programs
Ketamir-2: Unlocking the Potential of Ultra-Rapid Antidepressant Effects
MIRA's lead development product, Ketamir-2, has garnered significant attention for its potential to address treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDSI), and potentially post-traumatic stress disorder (PTSD). The drug's unique mechanism of action, which involves selective modulation of the NMDA receptor, has demonstrated promising results in pre-clinical studies, showcasing the ability to deliver ultra-rapid antidepressant effects.
In a recent pre-clinical study, MIRA reported that Ketamir-2 achieved a complete reversal of neuropathic pain in animal models, outperforming the FDA-approved treatments Gabapentin and Pregabalin by significant margins. The drug demonstrated up to 112% greater efficacy compared to Pregabalin, a widely-used medication for neuropathic pain management. These findings position Ketamir-2 as a potential breakthrough therapy that could redefine the standard of care for individuals battling chronic and debilitating pain conditions.
MIRA-55: Addressing Unmet Needs in Neuropsychiatric, Inflammatory, and Neurologic Disorders
Alongside Ketamir-2, MIRA Pharmaceuticals is also exploring the potential of its novel oral pharmaceutical marijuana molecule, MIRA-55. This innovative compound is currently under investigation for its ability to alleviate neuropathic pain, as well as anxiety and cognitive decline, symptoms often associated with early-stage dementia.
The company's pre-clinical research on MIRA-55 has yielded promising results, highlighting the drug's potential to address various neuropsychiatric, inflammatory, and neurologic diseases and disorders. If approved by the FDA, MIRA-55 could represent a significant advancement in the treatment of these complex and often debilitating conditions.
Overcoming Challenges and Building a Resilient Foundation
The development of novel pharmaceutical therapies is a complex and often arduous process, and MIRA Pharmaceuticals has not been immune to the challenges inherent in this industry. In early 2024, the company made a significant discovery during the manufacturing and scale-up process of its patented molecule, MIRA1a, leading to the identification of an improved version, MIRA-55.
This revelation, while initially disruptive, ultimately proved to be a strategic opportunity for MIRA Pharmaceuticals. The company promptly filed a provisional patent for MIRA-55, which encompasses all pre-clinical studies, and made the decision to advance MIRA-55 as its lead compound for the oral pharmaceutical marijuana drug candidate, while still retaining the rights to MIRA1a.
Navigating the Regulatory Landscape and Securing Partnerships
MIRA Pharmaceuticals has navigated the complex regulatory environment with diligence, obtaining favorable scientific reviews from the U.S. Drug Enforcement Administration (DEA) for both Ketamir-2 and MIRA-55. The DEA concluded that these compounds would not be considered controlled substances or listed chemicals under the Controlled Substances Act and its governing regulations, a significant milestone for the company.
In addition to its internal drug development efforts, MIRA Pharmaceuticals has established strategic partnerships to support its growth. In late 2023, the company entered into an exclusive license agreement with MIRALOGX, LLC, a related party, to develop and commercialize Ketamir-2 in the United States, Canada, and Mexico. This partnership provides MIRA Pharmaceuticals with the necessary resources and expertise to advance the drug's clinical development and potentially bring it to market.
Financials
Navigating Liquidity Challenges and Securing Funding
As a pre-clinical-stage company, MIRA Pharmaceuticals has faced the common challenge of ensuring adequate liquidity to fund its ongoing operations and future pre-clinical and clinical trials. The company has historically financed its activities through the sale of common stock and related-party financings, and it continues to explore additional sources of funding to support its growth.
As of June 30, 2024, MIRA Pharmaceuticals had cash of approximately $2.80 million, which the company expects will enable it to fund operations through the fourth quarter of 2024. However, the company acknowledges that additional financing will be needed to continue and complete pre-clinical and clinical development activities, as well as to commercially develop and launch its product candidates.
The company has taken steps to strengthen its financial position, including filing a shelf registration statement on Form S-3 with the SEC in August 2024, which provides the flexibility to raise additional capital through various financing options as needed.
For the six months ended June 30, 2024, MIRA Pharmaceuticals incurred $1.38 million in research and development expenses, primarily related to the initial payments for pre-clinical research projects for Ketamir. The company also incurred $2.12 million in general and administrative expenses during the same period. MIRA Pharmaceuticals reported a net loss of $3.41 million for the six months ended June 30, 2024.
In the most recent quarter, the company reported no revenue, reflecting its pre-clinical stage status. The net loss for the quarter was $1,691,325, with operating cash flow (OCF) and free cash flow (FCF) both at -$863,929. These figures underscore the significant investments MIRA is making in its drug development programs and the ongoing need for capital to support its operations.
From a liquidity perspective, MIRA Pharmaceuticals maintains a strong balance sheet with no debt, as evidenced by its debt-to-equity ratio of 0. The company's current ratio and quick ratio both stand at 3.68, indicating a solid short-term liquidity position. Additionally, MIRA has access to a $3 million related party loan agreement with MIRALOGX, LLC, which remains untapped as of June 30, 2024, providing an additional financial cushion if needed.
Overcoming Setbacks and Maintaining Momentum
MIRA Pharmaceuticals has not been without its share of setbacks, but the company has demonstrated its resilience and ability to pivot in the face of challenges. The discovery of MIRA-55 as an improved version of the previously developed MIRA1a molecule is a testament to the company's commitment to innovation and its willingness to adapt its strategy to optimize its drug candidates.
Furthermore, the company has proactively addressed potential regulatory hurdles by engaging with the DEA and securing favorable reviews for both Ketamir-2 and MIRA-55. This accomplishment underscores MIRA Pharmaceuticals' dedication to navigating the complex regulatory landscape and positioning its products for future success.
Looking Ahead: Positioning for Growth and Impact
As MIRA Pharmaceuticals continues to forge ahead, the company remains focused on advancing its neuroscience programs and bringing much-needed treatment options to patients. With the promising pre-clinical results for Ketamir-2 and MIRA-55, the company is well-positioned to potentially revolutionize the way neurologic, neuropsychiatric, and pain-related disorders are managed.
The upcoming presentation of Ketamir-2 data at the 18th Annual Pain Therapeutics Summit in Boston will provide an opportunity for MIRA Pharmaceuticals to further showcase the drug's superior efficacy and positioning as a potential breakthrough therapy. Additionally, the company's continued efforts to secure the necessary funding and partnerships will be critical in driving its pipeline forward and ultimately delivering on its mission to improve patient outcomes.
MIRA Pharmaceuticals' story is one of resilience, innovation, and a relentless pursuit of solutions to address significant unmet medical needs. As the company navigates the challenges and complexities of the pharmaceutical industry, its unwavering commitment to its neuroscience programs and its ability to adapt to changing circumstances position it as a promising player in the ever-evolving landscape of healthcare.
However, it's important to note that the company's financial position raises substantial doubt about its ability to continue as a going concern. MIRA Pharmaceuticals does not have sufficient cash and cash equivalents as of the date of its most recent filing to support operations for at least the next 12 months. This underscores the critical importance of the company's ongoing efforts to secure additional funding and strategic partnerships to advance its promising drug candidates through the development pipeline and towards potential commercialization.