Aquestive Therapeutics (AQST) investor relations material

Regulatory update and next steps

• Received a Complete Response Letter (CRL) from the FDA for Anaphylm, primarily focused on human factors related to product handling and administration, not clinical deficiencies.

• Required to rerun a human factors validation study and conduct an additional pharmacokinetic (PK) study, both considered efficient in terms of time and cost.

• Plan to resubmit the NDA in the third quarter, with all protocols and CROs in place and a Type A meeting scheduled to confirm study details.

• Improvements include simplifying packaging and adding clearer instructions to address FDA concerns.

• Success in the human factors study is qualitatively assessed, aiming for a threshold of around 90% correct use.

Market landscape and product positioning

• The market for anaphylaxis treatments is growing, with robust auto-injector sales and a new nasal spray competitor increasing awareness.

• Needle-free alternatives address significant unmet needs, as many patients delay or avoid using injectable epinephrine due to form factor and convenience.

• The company is expanding its sales force and medical affairs presence, focusing on education and engagement with the allergy community.

• Believes its film-based product offers a more compelling alternative to both auto-injectors and nasal sprays.

• Payer engagement is a key focus to ensure successful market access.

Launch preparation and financial position

• Medical affairs is prioritizing conference presence, publications, and outreach to prescribers to build trust and awareness.

• Ended the year with $120 million in cash, with additional financing secured and sufficient funds to support launch preparations and ongoing studies.

• Expect to end the year with $70 million in cash, not including potential out-licensing or additional capital.

• Confident in readiness for commercial launch, with all rights to Anaphylm retained and another product, Libervant, potentially available for out-licensing next year.