Aelis Farma S.A. Company Profile

Background

Overview

Aelis Farma S.A., founded in 2013 and headquartered in Bordeaux, France, is a clinical-stage biopharmaceutical company specializing in the development of treatments targeting the CB₁ receptor of the endocannabinoid system. The company focuses on creating Signaling Specific Inhibitors (CB₁-SSi) that selectively modulate the CB₁ receptor's activity, aiming to provide therapeutic solutions for various brain and peripheral diseases. This innovative approach is based on a natural regulatory mechanism discovered by Dr. Pier Vincenzo Piazza, the company's CEO, during his tenure at the Neurocentre Magendie of INSERM in Bordeaux.

Mission and Vision

Aelis Farma's mission is to pioneer a new class of drugs that offer safe and effective treatments for conditions associated with CB₁ receptor dysregulation. The company's vision is to become a leading player in the biopharmaceutical industry by advancing its proprietary CB₁-SSi platform to address unmet medical needs in brain and peripheral diseases.

Industry Significance

The company's focus on CB₁-SSi represents a significant advancement in pharmacology, as these compounds aim to selectively inhibit disease-related CB₁ receptor activity without disrupting its normal physiological functions. This targeted approach has the potential to provide new treatments for various conditions, including cognitive disorders, addiction, and metabolic diseases.

Key Strategic Focus

Core Objectives

• Development of CB₁-SSi Compounds: Advance the clinical development of AEF0117 and AEF0217, the company's lead drug candidates, through various stages of clinical trials.

• Expansion of Therapeutic Indications: Explore additional indications for CB₁-SSi compounds, including cognitive deficits associated with neurodevelopmental disorders and metabolic conditions.

• Strategic Partnerships: Forge collaborations with industry leaders to enhance the development and commercialization of its drug candidates.

Areas of Specialization

• Cannabis Use Disorders (CUD): Develop treatments targeting the adverse effects of excessive cannabis use.

• Cognitive Disorders: Address cognitive deficits associated with conditions such as Down syndrome (Trisomy 21).

• Metabolic Diseases: Investigate treatments for obesity and related metabolic conditions.

Key Technologies Utilized

• CB₁-SSi Platform: A proprietary technology that selectively modulates the CB₁ receptor's activity, aiming to provide therapeutic benefits without disrupting normal receptor functions.

Primary Markets Targeted

• United States: For the development of AEF0117 targeting CUD.

• Europe: For the development of AEF0217 targeting cognitive disorders, including Down syndrome.

Financials and Funding

Funding History

• Initial Public Offering (IPO): In February 2022, Aelis Farma successfully listed its shares on Euronext Paris, raising approximately €25 million.

• Capital Increase: In July 2024, the company conducted a capital increase of €4.5 million to support its R&D programs.

Recent Funding Rounds

• July 2024: Capital increase of €4.5 million.

Notable Investors

• Indivior PLC: Entered into an exclusive worldwide option license agreement with Aelis Farma for the development and commercialization of AEF0117.

Utilization of Capital

• Research and Development: Funding is primarily allocated to advancing the clinical development of AEF0117 and AEF0217.

• Operational Expenses: Support for the company's ongoing operations and strategic initiatives.

Pipeline Development

AEF0117

• Indication: Cannabis Use Disorder (CUD).

• Clinical Trials: Completed a Phase 2a study demonstrating efficacy; currently in a Phase 2b study in the United States.

• Regulatory Status: Positive recommendation from the Data Safety Monitoring Board; preparing for Phase 3 trials upon successful Phase 2b results.

AEF0217

• Indication: Cognitive deficits associated with Down syndrome (Trisomy 21).

• Clinical Trials: Completed a Phase 1/2 study in Spain; preparing for a multicenter Phase 2 study in Europe.

• Regulatory Status: Received €6 million grant from the European community for the development of AEF0217.

Technological Platform and Innovation

Proprietary Technologies

• CB₁-SSi Platform: Aelis Farma's proprietary technology that selectively modulates the CB₁ receptor's activity, aiming to provide therapeutic benefits without disrupting normal receptor functions.

Significant Scientific Methods

• Natural Regulatory Mechanism Mimicry: Developing compounds that replicate a natural brain defense mechanism against CB₁ receptor hyperactivity.

Leadership Team

Pier Vincenzo Piazza

• Position: Chief Executive Officer (CEO).

• Background: Co-founder of Aelis Farma; former Director of the Neurocentre Magendie of INSERM in Bordeaux.

• Contributions: Led the discovery of the natural regulatory mechanism of CB₁ receptor hyperactivity, forming the basis of the company's CB₁-SSi platform.

Arsène Guekam

• Position: Chief Corporate Development Officer.

• Background: Joined Aelis Farma in 2023; extensive experience in financial markets and sector trends.

• Contributions: Strengthened the company's corporate development strategy and partnerships.

Competitor Profile

Market Insights and Dynamics

• Market Size and Growth Potential: The global market for treatments targeting the endocannabinoid system is expanding, driven by increasing recognition of its role in various diseases.

• Industry Trends: Growing interest in cannabinoid-based therapies and personalized medicine approaches.

Competitor Analysis

• GW Pharmaceuticals (now part of Jazz Pharmaceuticals): Developed Epidiolex, an FDA-approved cannabinoid-based drug for rare epilepsy disorders.

• ACADIA Pharmaceuticals: Specializes in CNS disorders with its approved drug Nuplazid for Parkinson's disease psychosis.

• Corbus Pharmaceuticals: Develops endocannabinoid system modulators for inflammatory and fibrotic diseases.

• Vertex Pharmaceuticals: A biotech leader with a strong CNS pipeline, including pain and neurology programs.

Strategic Collaborations and Partnerships

• Indivior PLC: Entered into an exclusive worldwide option license agreement for the development and commercialization of AEF0117.

Operational Insights

• Strategic Considerations: Aelis Farma's focus on CB₁-SSi compounds differentiates it from competitors by targeting a novel mechanism of action.

• Competitive Advantages: Proprietary CB₁-SSi platform, strong leadership, and strategic partnerships position the company favorably in the market.

Strategic Opportunities and Future Directions

Strategic Roadmap

• Short-Term Goals: Complete ongoing clinical trials for AEF0117 and AEF0217; initiate Phase 2 studies in additional indications.

• Long-Term Goals: Expand the pipeline with new CB₁-SSi compounds; establish a global presence in the biopharmaceutical industry.

Opportunities for Expansion

• Geographic Expansion: Enter new markets in Asia and North America.

• Therapeutic Expansion: Develop treatments for additional conditions associated with CB₁ receptor dysregulation.

Future Objectives

• Regulatory Approvals: Achieve regulatory approvals for lead drug candidates in multiple regions.

• Commercialization: Launch AEF0117 and AEF0217 in key markets; explore licensing agreements for broader distribution.

Contact Information

• Website: www.aelisfarma.com

• LinkedIn