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*

diazepam^†

Breakthrough Seizures

Filed

In development as an oral rescue therapy for breakthrough seizures

Diazepam buccal film may address issues of invasiveness and consistency of absorption, with current standard of care — DIASTAT® (diazepam rectal gel)

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

Exservan^TM
(EU Partner: Zambon;
Seeking US Partner)

riluzole^†

ALS

Marketed since 2019

In development as a treatment for 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

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

APL-130277
(Partner: Sunovion)

apomorphine^†

Parkinson’s Disease

Filed

In development as a treatment for Parkinson’s disease

Potential to provide an alternate delivery method for patients with loss of body movement

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

Learn More

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.

Please complete the form below and click SEND to receive a copy of “Overcoming Solubility and Permeability Challenges,” a case study detailing the achievements made by Aquestive’s formulation team to create the diazepam buccal film.

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Whether we are partnering to out license our PharmFilm® technology or in-licensing adjacent assets, Aquestive works hand-in-hand with our partners to address their toughest clinical and business challenges. To learn more, please complete the following form:

Full name*
Email address*
Phone number*
What is your question?*
To subscribe to receive information updates about products and services from Aquestive Therapeutics, or to receive information about Aquestive-sponsored clinical trials, please check the box below. Please also review our privacy policy, which describes how we use and process your data. You may also contact us at any time by emailing busdev@aquestive.com.
Subscribe
- I would like to receive information updates regarding products and services from Aquestive, and information about Aquestive-sponsored clinical trials.

Please complete the form below and click submit to receive a copy of “The Art of LGS Book.”

First Name*
Last Name*
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Role within the Epilepsy Community*
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Tell us how we can assist you
- By providing my contact information, I agree that Aquestive Therapeutics (“Aquestive”) can use such information for its marketing database and that Aquestive and its agents may contact me by mail or email to provide information about Aquestive or its products or services. I understand that my contact information will not be sold to third parties, other than in the event Aquestive or its affiliates are sold. I understand that I have the right to opt-out of the database and have my information removed from the database at any time. Instructions on how to be removed from the database will be included in any future communications sent to me by Aquestive. Please also review our privacy policy, which describes how we use and process your data. You may also contact us at any time by emailing lgsart@aquestive.com.

Pipeline

An expanding portfolio

Reinventing medicines

Product Pipeline

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

In development as an oral rescue therapy for breakthrough seizures

In development as a treatment for anaphylaxis, severe allergy

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

In development as a treatment for amyotrophic lateral sclerosis (ALS)

Indicated to treat opioid dependency

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

In development as a treatment for Parkinson’s disease

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

Essential information for the investment community

Aquestive sponsored clinical trials

Clinical trial news and other updates

References

Please complete this form:

Please complete the form below and click SEND to receive a copy of “Overcoming Solubility and Permeability Challenges,” a case study detailing the achievements made by Aquestive’s formulation team to create the diazepam buccal film.

Please complete the form to receive a demonstration kit for our PharmFilm® technology.

Please complete this form:

Whether we are partnering to out license our PharmFilm® technology or in-licensing adjacent assets, Aquestive works hand-in-hand with our partners to address their toughest clinical and business challenges. To learn more, please complete the following form:

Please complete the form below and click submit to receive a copy of “The Art of LGS Book.”