AEON Biopharma (AEON) Registration Filing summary

Company overview and business model

• Clinical-stage biopharmaceutical company developing ABP-450 (prabotulinumtoxinA) for therapeutic indications, focusing initially on neurosciences.

• Holds exclusive development and distribution rights for ABP-450 in the US, Canada, EU, UK, and select international territories.

• ABP-450 is already approved for cosmetic use in some markets and is marketed as Jeuveau by Evolus for aesthetics.

• Recently shifted strategy to pursue a 351(k) biosimilar regulatory pathway using Botox as the reference product, after discontinuing Phase 2 migraine trials.

• Plans to initiate a pivotal Phase 3 study in cervical dystonia, subject to additional capital, with FDA discussions scheduled for Q3 2024.

Financial performance and metrics

• No product revenue to date; company has never been profitable from operations.

• Net loss for Q1 2024 was $118.0 million; accumulated deficit as of March 31, 2024 was $591.6 million.

• Cash and cash equivalents were $1.6 million as of March 31, 2024; expects to fund operations into Q4 2024.

• Losses from operations for Q1 2024 were $74.2 million; R&D expenses decreased due to wind-down of migraine trials.

• Substantial doubt exists about ability to continue as a going concern without additional financing.

Use of proceeds and capital allocation

• Will not receive proceeds from resale of shares by registered holders; proceeds from warrant or option exercises, if any, will be used for general corporate and working capital purposes.

• Not currently budgeting for cash proceeds from warrant exercises due to current stock price below warrant exercise price.

• Recent capital raised through convertible notes and PIPE investments; additional funding required for further development.