Product Pipeline

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Program

Molecule

Indication

Formulation Pre-Clinical/Proof of Concept Phase 1 Phase 2 Phase 3 Filed Marketed

CNS Programs

SYMPAZAN®

clobazam

Lennox-Gastaut syndrome

Marketed

Received FDA approval, November 1, 2018

Indicated to treat Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older

First and only film formulation of clobazam
Addresses dosing challenges associated with tablets and oral formulations of clobazam
For more information, visit www.sympazan.com or download the Prescribing Information

LIBERVANT^TM*
(Seeking Partner Outside US)

diazepam^†

Breakthrough Seizures / Cluster Seizures

Filed

In development as an oral rescue therapy for breakthrough seizures / cluster seizures

Diazepam buccal film may address issues of invasiveness and consistency of absorption experienced with other routes of administration

Complex Molecule Programs

AQST-108

epinephrine^†

Anaphylaxis, severe allergy

Phase 1

In development as a treatment for anaphylaxis, severe allergy

Anaphylaxis may impact as many as 1 in 20 people in the United States^2-4
Potential to be the first oral version of epinephrine available as a therapeutic solution for anaphylaxis

AQST-305

octreotide^†

Acromegaly / Carcinoid syndrome

Pre-Clinical/Proof of Concept

Pre-Clinical/Proof of Concept, proof of concept clinical studies in progress

In development as a treatment for patients with acromegaly and neuroendocrine tumors

Potential to decrease or possibly eliminate the burden associated with monthly depot intramuscular injections of octreotide

Licensed programs

SUBOXONE®
(Partner: Indivior)

buprenorphine / naloxone

Opioid Dependence

Marketed since 2010

Indicated to treat opioid dependency

Market leader for the treatment of opioid dependency
For more information, visit www.suboxone.com or download the Prescribing Information

ZUPLENZ®
(Partner: Midatech)

ondansetron

CINV / PINV

Marketed since 2010

Anti-emetic treatment for patients receiving chemotherapy, radiation therapy, or surgery

Provides an alternative for people who have difficulty swallowing
For more information, visit www.zuplenz.com or download the Prescribing Information

KYNMOBI^TM
(Partner: Sunovion)

apomorphine^†

Parkinson’s Disease

Approved since 2020

Indicated to treat parkinson’s disease

KYNMOBI™ (apomorphine hydrochloride) sublingual film is a prescription medicine used to treat short-term (acute), intermittent “off” episodes in people with Parkinson’s disease (PD).

For more information, visit www.kynmobi.com or download the Prescribing Information

EXSERVAN^TM
(EU Partner: Zambon;
Seeking Partner Outside EU)

riluzole

ALS

Licensed since 2019

Indicated to treat amyotrophic lateral sclerosis (ALS)

Dysphagia affects many people with ALS type 1
Exservan^TM may improve the ability of sufferers to use riluzole, proven to extend life and time to tracheotomy

AQST-119
(Partner: IntelGenx)

tadalafil^†

Erectile Dysfunction / BPH

Filed

In development as a therapy for the treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia

Potential to provide an alternate delivery method for those with erectile dysfunction

*Aquestive has received conditional acceptance of the use of this trade name, which is subject to final FDA review and acceptance

^†Subject to review, evaluation, and approval of the FDA

Essential information for the investment community

Keep current with Aquestive

Aquestive sponsored clinical trials

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Clinical trial news and other updates

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References

1. Holsti M, Dudley N, Schunk J, et al. Intranasal midazolam vs rectal diazepam for the home treatment of acute seizures in pediatric patients with epilepsy. Arch Pediatr Adolesc Med. 2010;164(8):747–753.

2. Fischer D, Vander Leek TK, Ellis AK, Kim H. Anaphylaxis. Allergy Asthma Clin Immunol. 2018;14(Suppl 2):54

3. Wood RA, Camargo CA Jr, Lieberman P, et al. Anaphylaxis in America: the prevalence and characteristics of anaphylaxis in the United States. J Allergy Clin Immunol. 2014 Feb;133(2):461-467.

4. Ma L, Danoff TM, Borish L. Case fatality and population mortality associated with anaphylaxis in the United States. J Allergy Clin Immunol. 2014;133(4):1075-1083.

SYMPAZAN® is a registered trademark of Aquestive Therapeutics, Inc.
SUBOXONE® is a registered trademark of Indivior UK Ltd.
ZUPLENZ® is a registered trademark of Midatech Pharma US Inc.
DIASTAT® is a registered trademark of Bausch Health Companies, Inc.
KYNMOBI^TM is a trademark of Sunovion Pharmaceuticals, Inc.

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Pipeline

An expanding portfolio

Reinventing medicines