We are a pre-clinical biotechnology company developing small molecule oral therapeutics for immune-mediated inflammatory diseases, or IMIDs. Our aim is to develop oral, safe and effective small molecule therapies that control inflammation, prevent tissue damage, improve quality of life and achieve long-term disease remission. (Incorporated in Delaware)

We believe that the lack of an in-depth understanding of the pathophysiological mechanisms underlying immune-mediated inflammation has restricted therapeutic options for several IMIDs to merely symptomatic interventions, with limited effectiveness. Our drug discovery and development approach combines artificial intelligence, or AI, and machine learning, or ML, with our team’s extensive experience and expertise, to decode the mechanisms and pathways that drive the initiation and progression of inflammation for patients with IMIDs.

We currently have two product candidates:

• INVA8001, which we plan to progress into Phase 2b of clinical development, and

• INVA8003, which is in early stage preclinical development.

We believe that our product candidates, INVA8001 and INVA8003, if approved, can potentially transform the treatment of several IMIDs, such as atopic dermatitis, or AD, and chronic urticaria, or CU, which are characterized by limited or no available therapeutic options or patient populations that are unresponsive, partially responsive or develop resistance to currently available therapies.

INVA8001 is designed as an oral, small molecule, highly selective and potent inhibitor of chymase, a key mediator of mast cells driving inflammation, epithelial barrier damage and fibrosis.

We in-licensed INVA8001 from Daiichi Sankyo Company, Limited, or Daiichi. We plan to submit an IND (Investigational New Drug) application to the FDA for INVA8001 in  atopic dermatitis (AD) in 2024 and, if cleared, initiate a Phase 2b trial for moderate to severe AD thereafter. We plan to initiate a Phase 1b trial for INVA8001 in chronic urticaria (CU) in 2024, subject to regulatory clearance.

We are currently conducting IND-enabling studies for INVA8003, and we intend to start good laboratory practice, or GLP, toxicology studies in 2024.

IMIDs encompass a clinically diverse range of unrelated conditions that share common inflammatory pathways and are characterized by disruptions in cellular homeostasis driven by common immune pathways and genetic factors. The prevalence of IMIDs is significant. Commonly known IMIDs include rheumatoid arthritis, the spondyloarthritis disease spectrum, connective tissue disorders, cutaneous inflammatory conditions (including psoriasis and AD), inflammatory bowel disease, asthma and autoimmune neurological diseases such as multiple sclerosis. Based on research available on the estimated population affected by each of these commonly known IMIDs, we estimate approximately 64 million individuals in the United States are living with a commonly known IMID. We also estimate more than 25 million individuals in the United States are living with AD, of which approximately 30 percent have moderate AD and approximately 10 percent have severe AD, which corresponds to approximately 10 million patients with moderate or severe AD in the United States. A feature of many IMIDs is the strong induction or dysregulation of an inflammatory response that begins with inflammasome activation and can eventually progress to matrix remodeling and fibrosis. Targeting and correcting a dysregulated inflammatory response to effectively address IMIDs may present a significant opportunity to develop novel and potentially transformative treatments.

*Note: Net loss of $8.05 million on no revenue for the 12 months ended June 30 2023

(Note: Invea Therapeutics filed its S-1 on Oct. 20, 2023, without disclosing terms for its IPO. The estimated IPO proceeds figure of $75 million is a placeholder figure.)