Company: MIRA
Filing Date: 2025-08-08
Form Type: DEFM14A
Source: 0001641172-25-022816
Chunk: 213

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-08-08
Form: DEFM14A
Chunk 213
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2025    |
| Valuation                  | Page 15 of 28 |

In contrast, aducanumab (brand name: Aduhelm™), another monoclonal antibody targeting beta-amyloid, was granted accelerated approval by the FDA in June 2021. However, its clinical efficacy remains uncertain due to inconsistent findings in clinical trials. As a result, the Centers for Medicare & Medicaid Services (CMS) limited coverage of Aduhelm to individuals enrolled in qualifying clinical studies.

The development and approval of these agents reflect ongoing efforts to target disease-modifying mechanisms in early-stage Alzheimer’s disease, although long-term outcomes and cost-effectiveness remain subjects of continued evaluation.

On July 2024, The FDA has approved Kisunla (donanemab-azbt)injection for the treatment of Alzheimer’s disease. Kisunla is a monoclonal antibody developed by Eli Lilly that targets and reduces amyloid plaques in the brain, which are a hallmark of Alzheimer’s disease. Treatment with Kisunla should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in the clinical trials.

MCI market size

According to market research performed by Research Nester 6, The global mild cognitive impairment (MCI) market is projected to grow from USD 2.3 billion in 2025 to USD 4.4 billion by 2037, at a CAGR of 6.1%. Growth is driven by rising Alzheimer’s cases, investment in genomic medicine, and public health initiatives promoting early diagnosis. However, challenges include high treatment costs and a lack of standard diagnostic criteria. The amnestic MCI segment is expected to dominate due to its association with more severe neurological conditions.

This report states that the North American market is predicated to obtain the largest share of 45.5% during the forecast period. Its inflated economic burden due to healthcare expenditures on the aging population is pushing the authorities and pharma leaders to focus on development in this sector.

Looking ahead, the U.S. MCI market is projected to experience significant growth. By 2037, it is estimated to reach USD 2.0 billion, expanding at a compound annual growth rate (CAGR) of 6.1% during the forecast period from 2025 to 2037.

6https://www.researchnester.com/reports/mild-cognitive-impairment-market/7049

| Moore Financial Consulting |

| MIRA Pharmaceuticals, Inc