Concussions and Neurodegenerative Therapeutics
Traumatic brain injuries, including concussions, trigger chemical imbalances in the brain. Harmful molecules called reactive oxygen species (ROS) and reactive nitrogen species (RNS) build up, creating oxidative stress that damage neurons, disrupt brain function, and impair recovery. Our therapies are designed to counteract these effects, and support the brain’s cellular repair mechanisms.
Mission
We are committed to developing safe and effective therapeutics designed to halt the progression of cellular damage caused by concussions and traumatic brain injuries (TBI). Our pioneering approach leverages the body’s intrinsic neuroprotective and reparative mechanisms, including antioxidant defense pathways, mitochondrial stabilization, and neuroinflammatory modulation. By targeting the root causes of neural injury at the biochemical, cellular, and subcellular levels, we aim to restore neuronal function, preserve synaptic integrity and support cognitive recovery.
Through rigorous preclinical and clinical research, including biomarker-guided assessments and advanced neuroimaging studies, we demonstrate the potential of our therapeutics not only to mitigate the acute effects of TBI but also to address secondary neurodegenerative cascades. Extensive published research supports the broader applicability of our compounds to Alzheimer’s disease, Parkinson’s disease, chronic traumatic encephalopathy (CTE), and related neurodegenerative disorders, underscoring their translational promise. Our ultimate objective is to restore cognitive function, protect neurological health, and meaningfully improve patients’ quality of life.

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Significant Unmet Needs
There are currently no FDA-approved pharmacological treatments for concussions, a type of mild Traumatic Brain Injury (mTBI).
Over 3 million concussions are reported annually in the US, but the true number may be 25–30 million, as it is estimated that only 1 in 9 cases receive treatment and are formally reported (CDC, 2024).
Traumatic Brain Injury is the leading cause of accidental death in the US for individuals over 45 years of age.
These injuries affect people of all ages—from children playing sports, to adults involved in accidents, to the elderly.
Repeated concussions can lead to cumulative neurodegenerative consequences, increasing the risk of chronic traumatic encephalopathy (CTE), dementia, Parkinson’s disease, and long-term cognitive decline.
Despite the high prevalence and severity of concussions, there is a critical unmet need for safe and effective therapeutics to prevent or mitigate these outcomes.

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Concussions and Brain Injury
When the brain experiences a concussion or other traumatic injury, it undergoes rapid chemical changes:
  • Oxidative Stress: Head trauma triggers production of reactive oxygen species (ROS) and reactive nitrogen species (RNS), which damage cells.
  • Secondary Injury Cascade: These chemical changes set off a chain reaction that can worsen brain damage over hours to days. A concussion is not just a single event—its effects ripple through the brain, creating a complex cascade of cellular stress and injury that can impact long-term brain function.
See:
M. Bains, E. D. Hall, Antioxidant therapies in traumatic brain and spinal cord injury, Biochimica et Biophysica Acta (BBA), Molecular Basis of Disease, 2012, https://doi.org/10.1016/j.bbadis.2011.10.017
Roth, T., Nayak, D., Atanasijevic, T. et al. Transcranial amelioration of inflammation and cell death after brain injury. Nature 505, 223–228 (2014). https://doi.org/10.1038/nature12808
Kursancew ACS, Faller CJ, Bortoluzzi DP, et al. Neuroinflammatory Response in the Traumatic Brain Injury: An Update. Neurochem Res. 2024;50(1):64. Published 2024 Dec 24. doi:10.1007/s11064-024-04316-4
Bolte AC, Shapiro D., Dutta A, Feng W, Bruch KA, Kovacs MA, Marco AR, HEnnerfelt HE, Lukens JR (2023) The meningeal transcriptional response to traumatic brain injury and aging eLife 12:e81154. https://doi.org/10.7554/eLife.81154
Neurotoxicity: Over activation of neurons can harm brain cells.
Inflammation: The immune system reacts, sometimes excessively, increasing tissue damage.
Cell Death: Brain cells may die through processes such as apoptosis or necrosis.
Brain Swelling (Edema): Fluid accumulation can increase pressure inside the skull.
Mitochondrial Dysfunction: Damaged energy-producing structures reduce cells’ ability to function.
Network Disruption: Neurons loose connections, impairing memory.

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Breaking the Cascade: Protecting the Brain from Concussion-Induced Damage
When the brain experiences a concussion or other traumatic injury, cellular damage releases damage-associated molecular patterns (DAMPs) that activate the immune system. This response triggers cytokines, chemokines, and recruitment of immune cells such as neutrophils, monocytes, microglia, and astrocytes. In severe cases, T and B lymphocytes may also be involved.
While intended to protect the brain, this immune activation can create a secondary injury cascade, where the body’s own response contributes to:
  • Neuroinflammation and oxidative stress
  • Cell death and neuronal loss
  • Mitochondrial dysfunction, impairing energy production
  • Cognitive, motor, and emotional deficits
Even mild concussions can have lasting effects, including headaches, dizziness, memory impairment, and emotional changes, which may persist for weeks or months. The brain’s high metabolic activity and delicate neurochemical balance make it especially vulnerable to oxidative damage.

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Targeting the Brain’s Injury Cascade
XMR99B’s unique molecular structure acts on both the primary biochemical injury and the secondary cascade of oxidative stress and inflammation. By addressing the root causes of cellular and molecular damage, XMR99B has the potential to:
  • Support cognitive recovery – help restore memory, focus, and overall brain function
  • Accelerate healing from traumatic brain injuries (TBI) – reduce cellular stress and promote repair
  • Mitigate long-term neurological and neurodegenerative consequences – protect neurons and maintain neural network integrity
Key Takeaway:
XMR99B intervenes at multiple levels of the injury cascade, offering a promising approach to protect, repair, and restore brain function after concussions and other neurological insults.

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Method and Mechanisms of Action

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Milestones & Outlook
Foundational Regulatory & Manufacturing Success
The FDA Investigational New Drug (IND) application has been successfully filed, and our Good Manufacturing Practice (GMP) process is fully validated, alongside the critical filing of our Drug Master File. These achievements pave the way for accelerated development.
Phase 1 Clinical Trial
Our Phase 1 study delivered exceptional results, demonstrating not only excellent safety data and pharmacokinetics but also groundbreaking pharmacodynamics, highlighted by XMR99B's unrivaled and prolonged bioavailability. This confirms our therapeutic's profound potential.
Anticipated Phase 2b: A New Horizon
We are thrilled to announce that the pivotal Jerry Kramer Neuro Studies (JKNS) is set to commence our crucial Phase 2b trial. This next phase promises to further validate XMR99B's efficacy and bring us closer to delivering a transformative solution.

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Mito Bioscience's team consists of world-renowned bimolecular scientists, researchers, and management with experience in discovery, investigation, pre-clinical and clinical trials, collaboration, and licensing. This includes regulatory approval of products in the U.S., Europe, Asia, and other global markets. A biography of Officers, Directors, Advisors, legal, and professional service providers will be made available upon request.
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Disclaimer
Certain information set forth in these documents contains “forward-looking information”. Except for statements of historical fact, information contained herein constitutes forward-looking statements and includes, but is not limited to, the (i) projected financial performance of the Company; (ii) the expected development of the Company’s business, projects and joint ventures; (iii) completion of, and the use of proceeds from, the potential sale of the shares; and (iv) execution of the Company’s vision and growth strategy, including with respect to future business development, pre-clinical, clinical and M&A activities and global growth. Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment.
These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements. The information herein is subject to review by FDA Regulatory Counsel, Debevoise & Plimpton.

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