Inventiva S.A. (NASDAQ: IVA)

Inventiva S.A., a clinical-stage biopharmaceutical company (ticker: IVA), operates in the healthcare sector, specifically focusing on the development of oral small molecule therapies for non-alcoholic steatohepatitis (NASH) and other diseases with significant unmet medical needs. The company's core business activities revolve around the discovery, development, and commercialization of novel small molecule compounds that target nuclear receptors, transcription factors, and epigenetic modulation.

Inventiva's main revenue generation comes from the development and commercialization of its lead product candidate, lanifibranor. This orally-available small molecule has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA) for the treatment of NASH. Lanifibranor has demonstrated promising results in pre-clinical and clinical development, showcasing anti-fibrotic, anti-inflammatory, and beneficial vascular and metabolic effects. This makes it a strong contender for addressing the needs of NASH patients.

In the NASH market, Inventiva holds a competitive edge due to its unique pan-PPAR agonist approach, which targets all three PPAR isoforms. This strategy distinguishes Inventiva from competitors such as Madrigal, Novo Nordisk, Akero Therapeutics, and 89 Bio. Lanifibranor's demonstrated effects position it as a promising treatment for NASH patients.

Inventiva's customers include patients with NASH and other diseases, healthcare providers, and pharmaceutical companies. The company has formed a partnership with CTTQ, a Chinese company, to support the clinical development and potential commercialization of lanifibranor in China.

The company's product portfolio includes lanifibranor, odiparcil, and the YAP/TAZ-TEAD program. Odiparcil, another orally-available small molecule, has received orphan drug designation from the FDA and EMA for the treatment of mucopolysaccharidoses (MPS) VI. Inventiva is currently evaluating options for further developing odiparcil for the treatment of MPS VI. The YAP/TAZ-TEAD program focuses on the development of new compounds that inhibit the YAP/TAZ-TEAD interaction for cancer treatment.

Inventiva's discovery engine, comprised of a team of approximately 90 experts, is a crucial asset. This team boasts deep knowledge in biology, medicinal and computational chemistry, pharmacokinetics, pharmacology, and clinical development. Additionally, the company owns a library of approximately 240,000 pharmacologically relevant molecules, 60% of which are proprietary.

Inventiva's competitive position in the NASH market is further strengthened by its strong intellectual property portfolio. The company owns six issued US patents and approximately 192 patents and patent applications in other jurisdictions for lanifibranor, and two issued US patents and approximately 87 patents in other jurisdictions for odiparcil.

Manufacturing of Inventiva's drug candidates is carried out by contract manufacturing organizations (CMOs) in accordance with the FDA's current Good Manufacturing Practices (cGMP) regulations. The company ensures that CMOs comply with cGMP regulations to maintain the quality and integrity of its drug products.

Inventiva is subject to extensive regulation by the FDA and other government agencies in the United States and abroad. The company must comply with FDA regulations and guidelines for the development, testing, and marketing of its drug candidates, and obtain FDA approval before marketing its drug candidates in the United States.