Aquestive Therapeutics (AQST) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Company overview and product focus

• Positioned as an emerging commercial pharmaceutical company with a focus on Anaphylm, a sublingual film for severe allergic reactions, pending FDA approval in the coming months.

• Product is highly portable and designed for ease of use in emergencies, addressing a key unmet need in the market.

Regulatory and clinical updates

• FDA's Complete Response Letter (CRL) focused on packaging and Instructions for Use, not clinical efficacy; these issues have been addressed with improved packaging and clearer instructions.

• Clinical questions have been resolved, and new data confirm pharmacokinetic (PK) bridging to auto-injectors and manual IM administration.

• Human factor studies show the product can be opened and administered in about 17 seconds, faster than current auto-injectors.

Clinical differentiation and patient preference

• Rapid onset of action, with measurable effects within 2 minutes and peak effects between 5–11 minutes, supports robust clinical response.

• Prodrug design enables efficient absorption without vasoconstriction in the mouth, differentiating it from traditional epinephrine delivery.

• Patient preference studies show strong favorability for the film over auto-injectors and nasal sprays after hands-on comparison.