FAScinate Therapeutics

What FAScinate Therapeutics does

FAScinate Therapeutics Inc. is a privately held, clinical-stage biotechnology company founded in 2018 and headquartered at 4365 Executive Dr. Ste. 660, San Diego, California. It operates as a wholly-owned US subsidiary of Kainos Medicine Inc., a South Korean clinical-stage biotech that completed an IPO in 2020, and is led by CEO Kisub Lee (also Board Chairman of Kainos Medicine) and President Dr. Jae Moon Lee (a Duke-trained biochemist), with Dr. Carrolee Barlow (former Merck Molecular Neuroscience director and Parkinson's Institute CEO) chairing the Scientific Advisory Board. The company focuses on developing disease-modifying therapeutics for central nervous system disorders, primarily Parkinson's disease and multiple system atrophy.

FAScinate's sole clinical asset is KM-819, an orally administered small molecule that inhibits Fas-associated factor 1 (FAF1), a proapoptotic protein implicated in dopaminergic neuron death. By suppressing FAF1-driven apoptosis and downstream alpha-synuclein (Lewy body) accumulation, KM-819 is positioned as a first-in-class disease-modifying candidate, contrasting with the dopamine-replacement standard of care that only addresses symptoms. The asset was licensed from Kainos Medicine for US development and commercialization. Phase 1 was completed in South Korea in January 2019 in 88 healthy volunteers with a clean safety profile; the FDA cleared the IND for Phase 2 in November 2021, and the program is now structured as Part 1a (dose-escalation in healthy elderly, completed January 2023), Part 1b (dose-finding in PD patients), and a Part 2 24-month efficacy study that explicitly includes GBA mutation carriers.

The company is pre-revenue with 1–10 employees and no commercial product. Its intended revenue model is licensing, co-development, and eventual commercialization of KM-819 with pharmaceutical partners, and it is actively soliciting investment and development partners through its partnerships page. Pricing, channels, and patient pricing strategy remain undetermined pending regulatory approval. Customer concentration is therefore not yet applicable: target end customers are PD and MSA patients (a population estimated at 1 million in the US and 6–10 million worldwide), but near-term counterparties are clinical trial sites and prospective pharma partners.

Name

FAScinate Therapeutics

Legal name

FAScinate Therapeutics Inc.

Website

https://fascinatetherapeutics.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

1–10 employees

Short description

FAScinate Therapeutics is a privately held, clinical-stage US biotech (San Diego) and wholly-owned subsidiary of Korea's Kainos Medicine, developing KM-819 — a first-in-class, orally administered small molecule that inhibits FAF1 to provide disease-modifying treatment for Parkinson's disease and multiple system atrophy. The company is currently running FDA-cleared Phase 2 trials and seeking development partners.

Ownership category

akta.pro rank

Product category

Neurological Therapeutics

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

akta.pro primary industry

Rare Neurology & Neurodegenerative Disorder Therapies (HLAIAIAD)

Keywords

• Neurodegenerative drug development
• Small molecule therapeutics
• Parkinson's disease treatment
• FAF1 protein inhibitor
• Disease-modifying therapy

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel

Revenue model

1. Pharmaceutical Development and Licensing: As a clinical-stage biotech, FAScinate generates revenue through licensing agreements, development partnerships, and ultimately commercialization of KM-819. The company has licensed KM-819 from parent company Kainos Medicine for clinical development and commercialization in the US market.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

FAScinate Therapeutics is developing KM-819, an orally active small molecule drug candidate that inhibits FAF1 (Fas-associated factor 1) proapoptotic proteins to protect dopaminergic neurons from cell death. KM-819 is a first-in-class disease-modifying therapy intended to slow or stop the progression of Parkinson's disease and multiple system atrophy, currently being evaluated in FDA-cleared Phase 2 clinical trials.

Product overview

FAScinate Therapeutics is a clinical-stage biotechnology company focused on developing disease-modifying drugs for neurodegenerative diseases. The company's primary product is KM-819, an orally active small molecule drug candidate that inhibits FAF1 proteins to protect dopaminergic neurons. KM-819 represents a novel approach as the first disease-modifying drug targeting FAF1 for Parkinson's disease. The company is currently conducting Phase 2 clinical trials to evaluate safety, tolerability, and efficacy in slowing or stopping Parkinson's disease progression. FAScinate operates as a subsidiary of Kainos Medicine (Korean biotech) and is based in San Diego, California.

Differentiator

Problem solved

Functional benefit

Products and services

• KM-819 KM-819 is an orally active small molecule drug candidate that inhibits FAF1 (Fas-associated factor 1) proapoptotic proteins to provide neuroprotection for dopaminergic neurons. It is a first-in-class disease-modifying treatment designed to slow or stop the progression of Parkinson's disease and potentially multiple system atrophy, currently in FDA-cleared Phase 2 clinical development.

Quantifiable outcome

• Phase 1 trial demonstrated safety and tolerability without drug-related serious adverse events
• +2 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Two partnerships are on record, tiered core and minor.

• Kainos Medicine Inc.coreStrategic or Co-development Partner · 1 January 2018FAScinate Therapeutics was founded in 2018 as a subsidiary of Kainos Medicine, a Korean biotech company. FAScinate has licensed KM-819 for clinical development and commercialization from Kainos Medicine, and is developing it for Phase 2 study in the US for Parkinson's Disease. Kainos Medicine is a clinical stage biotechnology company focused on discovery and early development of novel therapeutics for CNS diseases, cancer, and viral diseases.
• Investment and Development Partners (Seeking)minorOthersFAScinate is actively seeking investment and development partners to help change the future of treatment for neurodegenerative conditions like Parkinson's disease. Interested parties can reach out through the contact information provided on the partnerships page.

Scale indicators3 records

Recent moves7 records

Expansion highlights4 records

Direct peers

• Anavex Life Sciences: Clinical-stage biotech developing ANAVEX 2-73 for Parkinson's disease and Rett syndrome, with a similar small-cap, single-asset profile and CNS disease-modifying positioning that closely mirrors FAScinate's KM-819 strategy.
• Alterity Therapeutics: Clinical-stage company developing ATH434 for Multiple System Atrophy and Parkinson's disease — directly comparable in indication (especially MSA), stage, and small-cap profile to FAScinate.
• BioVie: Small clinical-stage company with a Parkinson's disease candidate (BIV201) targeting neurodegenerative mechanisms; comparable size, stage, and CNS focus to FAScinate.
• Prothena: Clinical-stage biotech with Parkinson's disease programs (prasinezumab, alpha-synuclein-targeting) and broader neurodegeneration pipeline; shares FAScinate's disease-modifying CNS focus.
• ESCAPE Bio: Clinical-stage company with Parkinson's disease and neurodegeneration candidates (including GBA-targeting programs); closely comparable in stage, indication, and small-cap clinical profile.
• Prevail Therapeutics: Gene therapy company developing AAV-based treatments for Parkinson's disease (PR001 for GBA-PD and GBA-PD MSA); directly comparable indication set, including MSA, and disease-modifying positioning.

Emerging players

• Denali Therapeutics: Clinical-stage biotech with a broad neurodegenerative disease pipeline including multiple Parkinson's programs (LRRK2, GBA); comparable disease-modifying approach though operating at significantly larger scale and capital base.
• Cerevel Therapeutics: Clinical-stage CNS-focused biotech with Parkinson's disease programs; shares FAScinate's CNS disease focus though operates at larger scale and is now part of AbbVie.

Broad incumbents

• Sage Therapeutics: Larger clinical-stage CNS company developing disease-modifying therapies for neurological conditions; comparable central nervous system focus though with a broader portfolio of programs.
• Biogen: Large biopharmaceutical company with multiple Parkinson's disease programs in its neuroscience pipeline; a relevant broad incumbent for benchmarking deal economics and competitive dynamics in PD.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments1 record

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about FAScinate Therapeutics