MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) reported a net loss of $10.4 million for the fiscal year ending December 31, 2025, compared to a loss of $7.9 million in the previous year. The company's total operating costs increased to $10.5 million from $8.0 million, driven primarily by a rise in general and administrative expenses, which reached $8.8 million, up from $4.7 million in 2024. This increase was largely attributed to stock-based compensation and payroll expenses. Research and development expenses decreased to $1.7 million from $3.3 million, reflecting reduced development costs for the MIRA-55 program.
In terms of strategic developments, MIRA Pharmaceuticals completed the acquisition of SKNY Pharmaceuticals, Inc. on September 29, 2025, which is expected to enhance its product pipeline. The acquisition included SKNY-1, a preclinical-stage oral therapeutic candidate targeting metabolic and addiction-related disorders. The company holds exclusive rights to three drug candidates: Ketamir-2, MIRA-55, and SKNY-1, which are designed to address significant unmet medical needs in various therapeutic areas.
Operationally, MIRA Pharmaceuticals has made progress in its clinical trials. Ketamir-2, an oral NMDA receptor modulator, has completed a Phase 1 clinical trial, and the company plans to initiate a Phase 2a study in chemotherapy-induced peripheral neuropathy (CIPN) in the first half of 2026. MIRA-55 is currently in preclinical development, with plans for an Investigational New Drug (IND) submission. The company reported cash and cash equivalents of approximately $6.3 million as of December 31, 2025, which it expects to be sufficient to fund operations into the first quarter of 2027.
MIRA Pharmaceuticals has faced challenges in generating revenue, as it has not yet commercialized any products. The company has an accumulated deficit of approximately $39.6 million and has indicated that it will require additional funding to support ongoing operations and clinical trials. The company is exploring various financing options, including public and private equity offerings, to alleviate concerns about its ability to continue as a going concern. The filing highlights the potential risks associated with its reliance on third-party manufacturers and the uncertainties inherent in the drug development process.
About MIRA PHARMACEUTICALS, INC.
MIRA Pharmaceuticals Inc. is a clinical-stage biotech focused on developing novel neuroscience therapies. Its key products include Ketamir-2, an oral ketamine analog for neuropathic pain and depression, and MIRA-55, a cannabinoid-based compound targeting neuroinflammation and cognitive decline. The company operates in North America, emphasizing safety, efficacy, and regulatory compliance to address unmet medical needs in neuropsychiatric and neurological disorders.
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