Invea Therapeutics (INAI) Registration Filing summary

Company overview and business model

• Focuses on developing oral, small-molecule therapies for immune-mediated inflammatory diseases (IMIDs), targeting conditions such as chronic urticaria, atopic dermatitis, and prurigo nodularis, among others.

• Utilizes the AlphaMeld Platform, integrating AI, machine learning, and generative AI for drug discovery and target identification.

• Lead candidate INVA8001 is a chymase inhibitor for mast cell-driven inflammation, with plans for Phase 2a trials in the EU for chronic inducible urticaria.

• Second candidate INVA8003 is a novel oral inhibitor targeting ASC for inflammasome-driven diseases, in preclinical development.

• Business model includes in-licensing, internal development, and potential strategic collaborations for commercialization.

Financial performance and metrics

• No product revenue to date; operations funded by parent company InveniAI, preferred stock, convertible notes, and SAFE instruments.

• Net losses: $6.3M (2024), $9.9M (2023); net loss of $2.9M for the nine months ended September 30, 2025.

• Cash on hand as of September 30, 2025: $0.3M; accumulated deficit: $26.8M.

• Significant working capital deficit and recurring operating losses; substantial doubt about ability to continue as a going concern.

Use of proceeds and capital allocation

• Proceeds will fund Phase 2a trial for INVA8001, preclinical development of INVA8003, repayment of $1.8M to InveniAI, repayment of related party and convertible notes, accrued liabilities, and licensing fees.

• Remaining funds allocated to general corporate purposes, working capital, and operating expenses.