COMPANY OVERVIEW

PhenoNet, Inc. Innovating Neurodegeneration Treatment for Patient Profile Cambridge, MA | Founded 2023

Lead Clinical Program: PHENOGENE-1A for ALS

Drug Candidate: PHENOGENE-1A (Cromolyn Inhalation Formulation) Indication: Mild to Moderate Amyotrophic Lateral Sclerosis (ALS) Regulatory Status: FDA authorization to proceed with planned clinical study

Study Design Highlights:

· Target Enrollment: 105 patients over ~18 months

· Treatment Duration: 24 weeks BID (twice daily) + 4-week safety follow-up

· Primary Endpoint: ALS Functional Rating Scale-Revised (ALSFRS-R) score change from baseline at 24 weeks

· Secondary Endpoints: CAFS, pulmonary function, and exploratory biomarkers

Mechanism of Action: Cromolyn is a multi-functional compound with demonstrated neuroprotective effects, including:

· Mast cell stabilization and inhibition of microglial activation

· Reduction in neuroinflammation and fibrosis

· Cytokine/chemokine suppression and enhanced neurite outgrowth

· Positive results in ALS animal models and a small human cohort

Company Overview

Mission: To discover, develop, and commercialize novel treatments for neurodegenerative diseases, with a focus on Alzheimer’s and ALS.

Key Programs:

· Study design- neuroinflammation progression treatment with

· PHENOGENE-1A – Repurposed, IP-protected cromolyn formulation optimized for CNS delivery

· PhenoCNU – Next-generation, dual activity for neuroinflammatory response and ligand/receptor-targeting therapy in preclinical development for ALS and AD

Differentiators:

· Patient profile targeting

· Use of well-characterized multifunction agents, safe compounds with novel delivery/formulation strategies

· Focus on early-stage neurodegeneration with measurable functional outcomes

· Dual emphasis on quality of life and disease modification


Forward-Looking Statement: Except for FDA approval information, this document contains forward-looking statements. Future outcomes may depend on clinical trial results, regulatory review, financial status, and competitive factors.
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