Company: MIRA
Filing Date: 2025-06-17
Form Type: PREM14A
Source: 0001641172-25-015340
Chunk: 186

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-06-17
Form: PREM14A
Chunk 186
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 The intensity of pain is often rated as moderate to severe and tends to worsen during nighttime hours, frequently disrupting sleep.

In addition to persistent pain, many patients experience cutaneous allodynia, where even light touch can provoke significant discomfort. This symptom burden has a substantial negative impact on health-related quality of life, impairing daily functioning, reducing participation in social and recreational activities, and contributing to psychological comorbidities such as depression.

Given its high prevalence, chronic nature, and the profound impact on patient well-being, DNP represents a significant area of unmet medical need. Current treatment options often provide limited relief, highlighting an opportunity for innovative therapies that can more effectively address both the physical and psychological dimensions of the condition.

DNP Diagnosis and Treatment Algorithm

The diagnosis of diabetic neuropathic pain (DNP) is multifaceted, requiring a combination of clinical assessment, neurological examination, and confirmatory diagnostic testing. Patients typically present with hallmark symptoms such as burning, tingling, or shooting pain in the extremities, often accompanied by sensory disturbances or loss of sensation.

A comprehensive patient history—focusing on diabetes duration and glycemic control—is a critical component of the diagnostic process. Neurological evaluations assess sensory function, deep tendon reflexes, and motor strength. To confirm peripheral neuropathy and exclude differential diagnoses, additional diagnostic modalities such as nerve conduction studies, electromyography (EMG), quantitative sensory testing, and imaging (e.g., MRI) may be employed. Effective diagnosis and ongoing management often require a multidisciplinary approach involving primary care providers, neurologists, endocrinologists, and pain specialists.

1Delveinsight - Diabetic Neuropathic Pain (DNP) - Market Insight, Epidemiology and Market Forecast -2034, published 2024

| Moore Financial Consulting |

| MIRA Pharmaceuticals, Inc. | April 2025   |
| Valuation                  | Page 9 of 28 |

Current Treatment Paradigm

The therapeutic management of DNP is two-pronged:

| 1. | Disease-Modifying                                                                     
 Interventions: Aimed at slowing or halting nerve fiber degeneration through optimized 
 glycemic control and management of metabolic factors.                                 |

| 2. | Symptomatic                                                                          
 Treatments: Focused on alleviating neuropathic pain and improving patient quality of 
 life, including physical and psychological functioning.                              |

Clinical guidelines generally recommend tricyclic antidepressants (TCAs), serotonin-norepinephrine reupt