As Parkinson’s disease advances, patients experience a decline in motor function, characterized by tremor, stiffness, and difficulty with movement. Current treatments can provide temporary relief of these symptoms but do not address processes which drive disease progression. As the disease advances, current therapeutic approaches become less effective and side effects increase. This results in sub-optimal outcomes leading to increasing clinical time to balance side effects vs. efficacy. It creates a significant burden on patients, caregivers, and healthcare systems.

Currently, there are no approved therapies available that slow the progression of the underlying disease or adequately relieves the wide range of symptoms in people with more advanced PD.

Arena Therapeutics has class II clinical evidence that shows the potential to slow disease progression in early-stage patients. Arena’s Targeted Brain Modulation also shows prolonged efficacy outcomes in later-stage patients.

Parkinson's disease is a progressive neurodegenerative disorder that affects millions worldwide. In the earliest stages, symptoms are mild but become more severe over time.

While the true root cause of Parkinson’s disease is unknown, its cardinal motor symptoms are believed to result from the loss of dopamine-producing cells within the substantia nigra, a critical area of the brain responsible for regulating movement and muscle tone.

Parkinson’s disease is typically not diagnosed right away. It has been estimated that by the time Parkinson’s is diagnosed, most people have lost 50 to 70 percent of their dopamine-producing cells within the substantia nigra.

No currently approved therapy (drug, biologic, or medical device) has been shown to slow progression for the 90,000+ individuals diagnosed annually with Parkinson’s Disease in the U.S. Reference: https://pmc.ncbi.nlm.nih.gov/articles/PMC9755252/

Currently approved brain modulation therapies, while effective for symptoms management are only approved for mid to advanced-stage patients.

Arena’s Targeted Brain Modulation therapy has growing medical and scientific evidence that it can arrest the progression of Parkinson’s disease motor symptoms. Arena is seeking an early-stage indication would allow its Targeted Brain Modulation therapy to be used in the >90K patients diagnosed annually, opening up an additional >$2.2B market in the U.S.

Parkinson's disease imposes a significant societal burden, impacting individuals, families, and the healthcare system in a number of ways

• Direct medical costs such as doctor visits, tests, and treatment costs.

• Indirect costs such as lost productivity, caregiver burden, and reduced quality of life.

• Societal costs such as healthcare system strain and social security and disability costs.

A 2020 study conducted and published by the Michael J. Fox Foundation, estimated the total direct and indirect costs of Parkinson’s disease in the U.S. to be $51.9 billion annually. Over half of those costs, $26.5 billion, are non-medical, such as lost productivity, wages, and disability. Reference: NPJ Parkinson’s Disease (2020) 6:15; https://doi.org/10.1038/s41531-020-0117-1

Current Parkinson’s disease therapies come at the cost of approximately $130K over 20 years* to manage symptoms.

Coupled with the inability to halt disease progression, this leads to substantial healthcare expenses over the patient’s lifetime.

* Based on Subthalamic Nucleus Deep Brain Stimulation May Reduce Medication Costs in Early-Stage Parkinson’s Disease Journal of Parkinson’s Disease 6 (2016) 125–131 125 DOI 10.3233/JPD-150712.

Early intervention with Arena’s Targeted Brain Modulation therapy can help slow disease progression and reduce the long-term cost impact.

1. Device Procurement: These devices will be used to deliver Arena’s Targeted Brain Modulation therapy in the company’s pivotal clinical trial in early-stage Parkinson’s disease.

2. Updated FDA IDE Approval: The company will provide a final protocol to the FDA to update its current approval to conduct the pivotal clinical trial in early-stage Parkinson’s disease.

3. Clinical Sites Contracting and Preparation: Arena will put contracts in place and provide training for the clinical trial sites participating in its pivotal clinical trial in early-stage Parkinson’s disease.

1. Device Development: Continued innovation and refinement of our Targeted Brain Modulation therapy including commercial devices and our proprietary targeting software.

2. Later-Stage Patients: Arena will complete all documentation and testing required to obtain FDA approval of its Targeted Brain Modulation therapy in later-stage patients.

3. Early-Stage Patients: The company will complete enrollment in its pivotal clinical trial for early-stage Parkinson’s patients that will lead to future FDA approval.