AyuVis Research, Inc. Market Research Report

Background

Overview

AyuVis Research, Inc. is a preclinical-stage biopharmaceutical company founded in 2014 and headquartered in Fort Worth, Texas. The company specializes in developing novel small-molecule immunotherapies aimed at preventing and treating life-threatening diseases characterized by inflammation and infection. AyuVis focuses on conditions with significant unmet medical needs, particularly in the realm of respiratory diseases.

Mission and Vision

AyuVis is dedicated to creating transformative immunotherapies that modulate the body's innate immune system to combat inflammation and infection without causing immunosuppression or contributing to drug resistance. The company's vision is to provide accessible and affordable treatments for critical conditions, thereby improving patient outcomes and quality of life.

Primary Area of Focus

The company's primary focus is on developing small-molecule immunotherapies that target the innate immune system to treat both acute and chronic inflammatory and infectious diseases. AyuVis's lead drug candidate, AVR-48, is designed to prevent bronchopulmonary dysplasia (BPD) in preterm infants, a condition with no current FDA-approved therapies.

Industry Significance

AyuVis operates within the biopharmaceutical industry, contributing to the advancement of immunotherapy treatments. By focusing on conditions with high unmet medical needs, such as BPD, the company aims to address significant gaps in current medical treatments, potentially improving patient outcomes and reducing healthcare costs associated with chronic diseases.

Key Strategic Focus

Core Objectives

AyuVis's strategic objectives include:

• Developing novel small-molecule immunotherapies that modulate the innate immune system to treat inflammation and infection.

• Addressing unmet medical needs in respiratory diseases, particularly BPD in preterm infants.

• Ensuring that treatments are accessible and affordable across different income levels globally.

Specific Areas of Specialization

The company specializes in:

• Designing small-molecule drugs that stimulate macrophages to control inflammation and infection.

• Focusing on respiratory diseases with high unmet medical needs, such as BPD, acute respiratory distress syndrome (ARDS), and ventilator-associated pneumonia (VAP).

Key Technologies Utilized

AyuVis employs:

• Rational drug design and computational modeling to develop novel compounds.

• Preclinical research models to evaluate the efficacy and safety of drug candidates.

Primary Markets or Conditions Targeted

The company targets:

• Preterm infants at risk of BPD.

• Patients with ARDS, VAP, and other respiratory conditions.

• Individuals affected by multi-drug resistant infections.

Financials and Funding

Funding History

AyuVis has secured both non-dilutive and private funding to support its research and development efforts:

• Non-Dilutive Funding: The company has received a total of $4.17 million in Small Business Innovation Research (SBIR) and Research grants from the National Institutes of Health (NIH), including grants from the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Child Health and Human Development (NICHD), and the National Heart, Lung, and Blood Institute (NHLBI).

• Private Funding: AyuVis has raised $5.1 million in angel private funding.

Recent Funding Rounds

The company is currently raising $16 million in a Series A funding round to support clinical trials.

Notable Investors

While specific investor names are not publicly disclosed, AyuVis has received support from various angel investors and has been associated with organizations such as TechFW, a nonprofit technology business incubator and accelerator in Fort Worth.

Intended Utilization of Capital

The capital raised is intended to:

• Fund Phase 1 safety and Phase 2a early proof-of-concept clinical trials for AVR-48.

• Advance the company's pipeline of immunotherapies targeting respiratory diseases.

Pipeline Development

Key Pipeline Candidates

AyuVis's lead drug candidate is AVR-48, a small-molecule immunotherapy designed to prevent BPD in preterm infants.

Stages of Clinical Trials or Product Development

AVR-48 has received FDA acceptance for an Investigational New Drug (IND) application and is proceeding with a Phase 1 clinical trial.

Target Conditions

The primary target condition for AVR-48 is BPD in preterm infants.

Relevant Timelines for Anticipated Milestones

The Phase 1 clinical trial for AVR-48 is expected to begin in 2024.

Technological Platform and Innovation

Proprietary Technologies

AyuVis has developed a series of novel small molecules derived from chitohexaose, designed to modulate the innate immune system by converting circulating white blood cells into macrophages that reduce inflammation and infection.

Significant Scientific Methods

The company employs rational drug design and computational modeling to develop its compounds, ensuring they are easy to manufacture, formulate, and have a high safety margin.

Leadership Team

Key Executive Profiles

• Dr. Suchismita Acharya, PhD – Founder and CEO

Dr. Acharya brings over 20 years of experience in pharmaceutical drug discovery, development, clinical trials, and project management. Prior to founding AyuVis, she spent 12 years in leadership roles with Alcon Labs/Novartis, leading R&D projects in ophthalmology. She is an innovative scientist, inventor of patents, and has managed small molecule drug discovery projects from hit to lead, lead optimization, Phase 1-3 clinical trials, and commercialization.

• Dr. David Riley, MD, MBA – Chief Medical Officer

Dr. Riley is board-certified in pediatrics and neonatal-perinatal medicine at Cook's Children Hospital in Fort Worth, TX. He received his undergraduate degree in Biochemistry from Cornell University, medical degree from Stanford University School of Medicine, completed his pediatric residency at the University of North Carolina Hospitals, and neonatal-perinatal fellowship at the University of Texas in Houston. His research interests include neonatal immunology and infectious disease, respiratory physiology, and evidence-based medicine.

• Dr. Dennis Dean, PhD – Head of CMC

Dr. Dean is an innovative process chemist with over 30 years of experience in synthetic organic chemistry, heterocyclic chemistry, process development, route selection, optimization, and process validation. He has extensive experience in CMC and compliance areas related to GMP API manufacturing, including regulatory filings and GMP audits of API manufacturers.

• Dr. Dale Christensen, PhD – Director of Early Development

Dr. Christensen has over 25 years of R&D experience from both small and large pharmaceutical companies. He specializes in developing novel therapeutics with an emphasis on IND-enabling toxicology and safety pharmacology studies. He has expertise in developing and reviewing study protocols, managing preclinical CROs, analyzing data, and troubleshooting toxicity, pharmacokinetics, and safety pharmacology studies for preclinical and IND-enabling studies.

Competitor Profile

Market Insights and Dynamics

The biopharmaceutical industry, particularly in the field of immunotherapies for respiratory diseases, is characterized by significant competition and rapid innovation. Companies are striving to develop effective treatments for conditions with high unmet medical needs, such as BPD, ARDS, and VAP.

Competitor Analysis

AyuVis's key competitors include:

• Spero Therapeutics

A biopharmaceutical company focused on developing therapies for multi-drug resistant infections.

• Melinta

A company specializing in the discovery and commercialization of novel antibiotics.

• Prokaryotics

A biopharmaceutical firm developing treatments for infectious diseases.

These competitors have raised significant funding and are actively developing therapies targeting similar indications.

Strategic Collaborations and Partnerships

AyuVis has engaged in strategic collaborations to enhance its development capabilities.