Company History and Overview
MIRA Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company that is pioneering the development of innovative therapies to address unmet needs in the areas of neurological and neuropsychiatric disorders. With a focus on transforming the treatment landscape, MIRA is making significant strides in advancing its lead pipeline candidates, Ketamir-2 and MIRA-55, which hold immense potential to revolutionize the management of neuropathic pain, treatment-resistant depression, and early-stage dementia.
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. The company's journey began with the in-licensing of exclusive rights to Ketamir-2, a novel oral ketamine analog, and MIRA-55, a proprietary oral pharmaceutical marijuana compound, for the United States, Canada, and Mexico.
In its early stages, MIRA focused on establishing a robust preclinical development program to thoroughly evaluate the safety, efficacy, and pharmacological properties of its lead candidates. The company initially financed its operations through the sale of common stock and related party financings. As a pre-clinical-stage pharmaceutical development company, MIRA has been primarily engaged in developing its lead product candidate, MIRA-55, and more recently has also been focusing on the development of Ketamir-2.
A significant milestone for MIRA Pharmaceuticals came in 2023 when the company completed an initial public offering, raising additional capital to fund its continued development efforts. Around this time, the company also entered into a promissory note and loan agreement with a major shareholder, Bay Shore Trust, to help fund the development of its licensed products.
In early 2024, MIRA made a significant discovery during the manufacturing and scale-up process of its patented molecule known as MIRA1a. Through this process, the company identified a novel and improved version of the molecule, which it calls MIRA-55. This discovery led the company to promptly file a provisional patent for MIRA-55, which encompasses all of its pre-clinical studies to date.
Throughout its history, MIRA Pharmaceuticals has faced challenges in funding its ongoing operations and future pre-clinical and clinical trials required for FDA approval. The company has had to rely on external funding to finance its activities, as it has sustained substantial losses since inception. Managing its liquidity needs and securing the necessary resources to progress its product candidates has been an ongoing challenge for the company.
Financial Performance and Liquidity
As a clinical-stage biotechnology company, MIRA has not yet generated any revenue from product sales, as its lead candidates are still in the development pipeline. The company has relied on strategic financing activities, including private placements and an initial public offering (IPO) in 2023, to fund its research and development efforts.
For the year ended December 31, 2023, MIRA reported a net loss of $6.19 million, primarily driven by research and development expenses of $1.19 million and general and administrative costs of $3.83 million. The company's cash and cash equivalents stood at $4.60 million as of the same period, providing a solid foundation to advance its pipeline.
In the third quarter of 2024, MIRA's net loss narrowed to $2.04 million, compared to a net loss of $3.59 million in the same period of 2023. This improvement in profitability was primarily due to lower general and administrative expenses, as the company incurred higher stock-based compensation and IPO-related costs in the prior year period. Research and development expenses for the nine months ended September 30, 2024, increased to $2.44 million, up from $1.19 million in the same period of 2023, reflecting MIRA's continued investment in advancing its Ketamir-2 and MIRA-55 programs through pre-clinical studies.
The company's cash position remained strong at $4.14 million as of September 30, 2024, bolstered by the successful execution of an At-The-Market (ATM) equity offering program, which raised an additional $3.13 million in net proceeds during the nine months ended September 30, 2024. This financial strategy has been instrumental in sustaining MIRA's operations and advancing its pipeline.
MIRA's focus on efficient capital management and its ability to access the public markets have been crucial in funding its activities. The company's current cash runway is expected to fund its operations through the fourth quarter of 2025, providing ample time to achieve key milestones in the development of Ketamir-2 and MIRA-55.
However, it is important to note that MIRA does not currently have sufficient cash and cash equivalents to support its operations for at least the next 12 months. The company's ability to continue as a going concern is dependent on obtaining significant additional external funding in the near term. This situation raises substantial doubt about MIRA's ability to continue as a going concern beyond the next 12 months.
To address its liquidity needs, MIRA has secured a $3 million loan agreement with MIRALOGX, LLC, a related party, which has not been drawn upon as of September 30, 2024. This provides an additional financial cushion for the company as it progresses its development programs.
Ketamir-2 A Promising Approach to Neuropathic Pain
MIRA's lead clinical candidate, Ketamir-2, is a novel oral ketamine analog that has demonstrated remarkable potential in preclinical studies for the treatment of neuropathic pain, a debilitating condition characterized by chronic pain arising from nerve damage or dysfunction. Ketamir-2 has shown distinct advantages over existing FDA-approved treatments, such as gabapentin and pregabalin, in terms of efficacy, safety, and pharmacokinetic profile.
In preclinical studies, Ketamir-2 has consistently outperformed the current standard of care, achieving up to 112% greater efficacy in reducing chemotherapy-induced neuropathic pain compared to pregabalin, and 60% higher efficacy than gabapentin. Importantly, these findings highlight Ketamir-2's potential to address the significant unmet need in this debilitating condition, which affects millions of individuals worldwide and is often associated with limited treatment options and suboptimal outcomes.
MIRA's commitment to Ketamir-2's development is further underscored by the successful completion of its current Good Laboratory Practice (GLP) preclinical safety program, which confirmed no adverse findings. This milestone has paved the way for the company to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) by the end of 2024, allowing for the initiation of human clinical trials in the first quarter of 2025.
The upcoming Phase I/IIa clinical trial, which will be conducted at the Centre for Human Drug Research (CHDR) in the Netherlands, is designed to evaluate the safety, tolerability, and preliminary efficacy of Ketamir-2 in healthy subjects and patients with diabetic neuropathy. This innovative trial protocol, leveraging CHDR's proprietary PainCart® technology, is poised to provide valuable insights into Ketamir-2's therapeutic potential and further validate the preclinical data.
MIRA-55 Addressing Neuropsychiatric Disorders and Neuropathic Pain
Alongside Ketamir-2, MIRA's pipeline features MIRA-55, a novel oral pharmaceutical marijuana compound, which is being investigated for its potential to alleviate neuropathic pain, as well as anxiety and cognitive decline associated with early-stage dementia. This dual-indication approach underscores MIRA's strategic focus on addressing the complex and often interrelated nature of neurological and neuropsychiatric disorders.
Preclinical studies have demonstrated MIRA-55's ability to effectively manage neuropathic pain and provide improvements in anxiety and cognitive function in relevant animal models. These promising results have positioned MIRA-55 as a potential breakthrough therapy, particularly in light of the growing recognition of the therapeutic potential of pharmaceutical-grade cannabinoids in the treatment of various neurological and neuropsychiatric conditions.
MIRA's commitment to advancing MIRA-55 is evidenced by the recent discovery of an improved molecular formulation, MIRA-55, which has displayed enhanced potency and efficacy compared to the company's previous lead compound, MIRA1a. This development has prompted MIRA to prioritize the further development of MIRA-55, while retaining the rights to MIRA1a as a potential backup candidate.
Navigating the Regulatory Landscape and Exploring Strategic Partnerships
As MIRA Pharmaceuticals transitions into the clinical stage of development, the company is meticulously navigating the regulatory landscape to ensure the successful advancement of its pipeline. The submission of the IND application for Ketamir-2 to the FDA represents a significant milestone, underscoring MIRA's commitment to expediting the path to human trials and ultimately, potential regulatory approval.
Beyond the clinical development, MIRA is actively exploring strategic partnerships and collaboration opportunities that could further unlock the value of its innovative therapies. The company's management team is well-versed in the nuances of the pharmaceutical industry and is actively engaged in discussions with potential partners, seeking to leverage their expertise, resources, and global reach to enhance the commercialization potential of Ketamir-2 and MIRA-55.
Financial Outlook and Liquidity Management
MIRA's financial strategy is focused on maintaining sufficient liquidity to support its ongoing research and development activities while managing its cash burn rate effectively. The company's current ratio and quick ratio both stand at 6.107 as of September 30, 2024, indicating a strong short-term liquidity position. However, the absence of revenue and ongoing operational expenses necessitate careful financial planning and additional fundraising efforts.
The company's ability to secure additional financing through equity offerings, such as the successful ATM program, demonstrates investor confidence in MIRA's potential. However, the lack of sufficient cash to support operations for the next 12 months underscores the critical nature of securing additional funding to ensure the company's long-term viability and the continued advancement of its promising drug candidates.
Conclusion
MIRA Pharmaceuticals is poised to make a significant impact in the treatment of neuropathic pain, treatment-resistant depression, and early-stage dementia. With its robust preclinical data, innovative pipeline, and experienced management team, the company is well-positioned to navigate the regulatory landscape and forge strategic partnerships that could accelerate the development and commercialization of its transformative therapies.
As MIRA advances Ketamir-2 and MIRA-55 through clinical trials, investors will closely monitor the company's progress and the potential of these novel treatments to address the substantial unmet needs in the targeted neurological and neuropsychiatric indications. MIRA's focus on efficient capital management and its ability to access the public markets have been instrumental in sustaining its operations and advancing its pipeline, providing a solid foundation for the company's future growth and success.
The company's financial strategy, including the successful execution of its ATM program and the availability of a $3 million loan agreement, demonstrates MIRA's proactive approach to managing its liquidity needs. However, the ongoing challenge of securing sufficient funding to support long-term operations remains a critical focus for the management team.
As MIRA Pharmaceuticals continues to progress its innovative therapies through the development pipeline, the company's ability to achieve key clinical milestones, secure additional funding, and potentially forge strategic partnerships will be crucial in determining its trajectory towards becoming a leader in the treatment of neurological and neuropsychiatric disorders.