Market size & competition


Market Size

PD and LBD affects over 7 million humans (1.5% of world population); prevalence: grow to 2.89 million (2022).

Market size: $5 billion in sales/year of anti-PD therapeutics; expected to grow to $6.5 billion by 2022.

Only 7% of all anti-PD products in the pipeline are considered neuroprotective/disease-modifying.



Initial Market (based on our data)

CNS/CT-001 applicable to genetic PD (~2-5% of patients) and to treat Lewy Body Dementia patients. CNS/CT-001 can be used as preventive treatment in familial PD.

Anticipated Market Expansion

We anticipate CNS/CT-001 will have therapeutic effects in idiopathic PD, then compounds can access standard care for All PD patients (milestone data of idiopathic model by March of 2021.

- More than $1 billion/year in projected sales if 2 products in the pipeline are commercialized; estimate is based on oral, and intranasal Levodopa.



Competition

No disease modifying therapy available for PD; two intranasal compounds are in Phase 3 clinical trials.

GLP1 agonists and other anti-diabetic medications- require binding to a receptor; do not treat cognitive decline.



Our Business model

Primary customers:

Midsize and large pharmaceutical companies (medical nootropics, intranasal therapeutics, biosimilars).

-Companies who can scale up the products.

-Distributors and commercial partners.

-Hospitals and clinics

Secondary customers:

1) Milestone payments; pharmaceutical companies willing to fund research and development milestones to enable products in the pipeline reach IND status and scaled up via GMP.

2) Licensing- out-license to pharmaceutical companies that commercialize medical nootropics via the 502b route, develop biosimilars, and have a business portfolio in intranasal compounds.

3) Be acquired as a subsidiary (or VAN) of a larger pharmaceutical company for long-term sustainability and development of a larger pipeline.

4) Selling distributions and commercial agreements with distributors and commercial partners.



Therapeutic pipeline (current and future):

CNS/CT-001: Moderate to severe PD to treat motor symptoms. Most developed product at preclinical stage.

CNS/CT-002: For treating moderate to severe LBD PD cognitive decline, initiated studies.- POC stage.

CNS/CT-003 – Formulation with synthetically modified forskolin for enhanced blood brain barrier penetrance and nose-to-brain targeting ratio, leading to maximum brain availability for most severe forms of PD.

CNS/CellMed-001: Topical version of CNS/CT-001 by levering CellMedic’s patented transdermal product; used in PD patients that might experience nose irritation due to prolonged treatment with CNS/CT-001.