# EDGAR Filing Document

**Accession Number:** 0001398733
**File Stem:** 0001398733-25-000012
**Filing Date:** 2025-8
**Character Count:** 87535
**Document Hash:** 11592f9a2ab22204c34b24cc53bb26e8
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001398733-25-000012.hdr.sgml**: 20250811

**ACCESSION NUMBER**: 0001398733-25-000012

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 56

**CONFORMED PERIOD OF REPORT**: 20250811

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250811

**DATE AS OF CHANGE**: 20250811

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Aquestive Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001398733
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 208623253
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38599
- **FILM NUMBER:** 251201991

**BUSINESS ADDRESS:**
- **STREET 1:** 30 TECHNOLOGY DRIVE
- **CITY:** WARREN
- **STATE:** NJ
- **ZIP:** 07059
- **BUSINESS PHONE:** 908-941-1900

**MAIL ADDRESS:**
- **STREET 1:** 30 TECHNOLOGY DRIVE
- **CITY:** WARREN
- **STATE:** NJ
- **ZIP:** 07059

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** MonoSol Rx, Inc.
- **DATE OF NAME CHANGE:** 20070507

?xml version='1.0' encoding='ASCII'? aqst-20250811

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, DC 20549**

**FORM 8-K**

**CURRENT REPORT**

**PURSUANT TO SECTION 13 OR 15(d) OF THE**

**SECURITIES EXCHANGE ACT OF 1934**

**Date of Report (Date of earliest event reported): August 11, 2025**

Aquestive Therapeutics, Inc.

**(Exact name of Registrant as specified in its charter)**

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-38599** | **82-3827296** |
| **(State or other jurisdiction of incorporation)** | **(Commission File Number)** | **(I.R.S. Employer Identification No.)** |

---

**30 Technology Drive**

**Warren, NJ 07059**

**(908) 941-1900**

**(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant's Principal Executive Offices)**

**Not Applicable**

**(Former name or former address, if changed since last report)**

________________________________________________________________________________________________________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| Title of each class | Trading Symbol(s) | Name of each exchange on which<br>registered |
| Common Stock, par value $0.001 per share | AQST | Nasdaq Global Market |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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---

| | |
|:---|:---|
| **Item 2.02** | **Results of Operations and Financial Condition.** |

---

On August 11, 2025, Aquestive Therapeutics, Inc. (the "Company") issued a press release announcing its reported financial results for the second quarter ended June 30, 2025 and provided an update on recent developments in its business. A copy of the Company's press release and the attached financial schedules are attached as Exhibit 99.1 to this Current Report On Form 8-K and incorporated in this Item 2.02 by reference.

The information in this Item 2.02 (including Exhibit 99.1) shall not be deemed to be "filed" for purposes of, or otherwise subject to the liabilities of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.

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| | |
|:---|:---|
| **Item 7.01** | **Regulation FD Disclosure.** |

---

The Company is furnishing this Current Report on Form 8-K in connection with the disclosure of information, in the form of investor presentations, to be given at meetings with institutional investors, analysts and others. This information may be amended or updated at any time and from time to time through another Current Report on Form 8-K, a later Company filing or other means. A copy of the Company's investor presentations are attached hereto as Exhibits 99.2 and 99.3 to this Current Report on Form 8-K and incorporated into this Item 7.01 by reference. The investor presentations are available on the Events and Presentations page in the Investors section of the Company's website located at www.aquestive.com, although the Company reserves the right to discontinue that availability at any time.

The information in this Item 7.01 (including Exhibit 99.2) shall not be deemed to be "filed" for purposes of, or otherwise subject to the liabilities of Section 18 of the Exchange Act, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.

---

| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits** |

---

(d)Exhibits.

---

| | |
|:---|:---|
| Exhibit Number | Description |
| <u>[99.1](q22025-ex991earningsrelease.htm)</u> | Press Release, dated August 11, 2025, announcing the Company's reported financial results for the second quarter ended June 30, 2025 and providing an update on recent developments in its business. |
| <u>[99.2](q22025supplementalearnin.htm)</u> | Aquestive Therapeutics, Inc. Q2 Earnings Supplemental Materials dated August 11, 2025. |
| <u>[99.3](aquestive_corppresentati.htm)</u> | Aquestive Therapeutics, Inc. Corporate Presentation dated August 2025. |

---

**SIGNATURE**

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | |
|:---|:---|:---|
| Dated: **August 11, 2025** | Aquestive Therapeutics, Inc. | Aquestive Therapeutics, Inc. |
|  | By: | /s/ A. Ernest Toth, Jr |
|  |  | Name: A. Ernest Toth, Jr. |
|  |  | Title: Chief Financial Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![aqstlogo.jpg](aqstlogo.jpg)

**Aquestive Therapeutics Reports Second Quarter 2025 Financial Results** 

**and Provides Business Update** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *FDA accepts NDA submission for Anaphylm™; PDUFA date set for January 31, 2026*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *Planning continues for a Q1 2026 U.S. launch of Anaphylm, if approved by the FDA*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *Company accelerates Anaphylm global expansion strategy to Canada and the EU*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *Company to host investor call on August 12, 2025, at 8:00am ET*

Warren, N.J., August 11, 2025 – Aquestive Therapeutics, Inc. (NASDAQ: AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced financial results for the second quarter ended June 30, 2025, and provided a strategic business update.

"The second quarter marked a pivotal step forward for our Company with the FDA's acceptance of our NDA for Anaphylm which, if approved by the FDA, will be the first and only oral, sublingual film epinephrine product," said Daniel Barber, Chief Executive Officer of Aquestive. "As we advance preparations for a potential U.S. launch in 2026, we are also laying the groundwork for global expansion with initial regulatory engagements now underway with Canada and the EU. With regulatory progress on track, we remain focused on execution across clinical, commercial, and operational fronts, and continue to evaluate all available paths to bring Anaphylm to global markets efficiently and effectively, as we have done with other Aquestive products. I'm proud of our momentum and confident in our ability to bring forward a solution that makes epinephrine emergency treatment more accessible, portable, and patient-friendly."

**Anaphylm™ (epinephrine) Sublingual Film**

In the second quarter of 2025, the United States Food and Drug Administration (FDA) accepted Aquestive's New Drug Application (NDA) submission for Anaphylm, initiating its review process. The Company has responded to all FDA information requests received to date. Preparations are ongoing for a possible Advisory Committee meeting with the FDA ahead of the scheduled PDUFA date which is January 31, 2026. Aquestive is prepared to present clinical evidence supporting Anaphylm and address how Anaphylm would meet the significant unmet need for additional, non-invasive epinephrine delivery options. To date, Aquestive has completed 10 clinical studies, with approximately 935 total administrations across 379 subjects including 808 single-dose and 127 repeat-dose exposures. The Anaphylm program also includes a novel clinical trial for oral allergy syndrome (OAS), demonstrating Anaphylm's performance in a real-world, allergen-induced setting.

Aquestive continued to advance its U.S. commercial readiness strategy for Anaphylm during the second quarter. The Company is building a strong commercial launch team and leveraging existing infrastructure to support execution. Concurrently, the Company has launched global expansion activities with initial regulatory meetings planned in both Canada and the European Union. Aquestive remains committed to bringing Anaphylm to patients worldwide and views international markets as a critical component of its long-term commercial strategy.

Anaphylm could offer patients fundamental advantages that differentiate it from existing device-based epinephrine therapies. As an orally administered, non-device product candidate with a pharmacokinetic profile comparable to leading epinephrine injectables, Anaphylm has the potential to improve carry rates, simplify emergency response, and address long-standing barriers to epinephrine adoption, including fear of needles, stigma, and device complexity. These benefits, coupled with growing interest from healthcare professionals, payers, and advocacy groups, position Anaphylm as potentially transformative in emergency allergy treatment, if approved by the FDA. Aquestive is evaluating all commercial pathways for maximum reach and impact upon launch of Anaphylm, subject to FDA regulatory approval.

------

**AQST-108 (epinephrine) Topical Gel**

Aquestive continues to work toward its anticipated submission of an Investigational New Drug Application for AQST-108 for the treatment of alopecia areata (AA) to the FDA in the fourth quarter of 2025. During the second quarter, the Company made steady progress advancing the program's preclinical activities, designed to further support regulatory alignment and clinical success. AQST-108 remains uniquely positioned as a potential topical treatment option for AA, a condition affecting approximately 6.7 million people in the U.S., nearly half of whom suffer from severe AA. The existing therapies for AA are janus kinase (JAK) inhibitors. These systemic treatments come with known side effects, include a "black box" warning, and can be expensive for patients. Even with these limitations, the current estimated market for JAK inhibitors is more than one billion U.S. dollars. Since AQST-108 is topical and there is evidence that its effects target the application site, it may not cause systemic side effects. As a result, AQST-108, if approved by the FDA for the treatment for AA, has the potential to capture meaningful market share.

**Libervant® (diazepam) Buccal Film**

As previously disclosed, Libervant's regulatory status was revised from full to tentative approval following a court decision related to orphan drug exclusivity of another drug product. This change was not related to the safety or efficacy of Libervant, it stemmed from the court's interpretation of the orphan drug statute. The Company continues to believe that limiting access to a differentiated, non-invasive formulation restricts patient choice and imposes an unnecessary burden on caregivers. Aquestive remains committed to relaunching Libervant in 2027 or sooner if granted full marketing approval by the FDA.

**Commercial Collaborations**

Aquestive continues to manufacture Indivior's Suboxone<sup>®</sup> Sublingual Film product and its other global collaborations, including Sympazan<sup>®</sup> (clobazam) Oral Film product for Assertio Holdings, Inc., Ondif<sup>®</sup> (Ondansetron) Oral Film product for Hypera in Brazil, and Emylif<sup>®</sup> (Riluzole) Oral Film product for Zambon in Europe. Aquestive's manufacturing business remains steady, with the gradual decline of Suboxone<sup>®</sup> being offset by growth across newer collaborations. Aquestive's manufacturing facility continues to diversify its operations to support a broader range of products and collaborations. In addition, the Company, being a U.S. based manufacturer with intellectual property domiciled in the U.S., confirms that its supply chain currently remains largely unaffected by both implemented and proposed tariffs, providing continued reliability and stability in production and global distribution for the near term.

Sales of royalty-based products, inclusive of Sympazan<sup>®</sup> (clobazam) Oral Film for the treatment of seizures associated with Lennox-Gastaut Syndrome in patients two years of age and older, and Azstarys<sup>®</sup> (serdexmethylphenidate and dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients six years of age and older, continued to contribute to the Company's revenue in the second quarter of 2025.

**Second Quarter 2025 Financials**

Excluding the impact of one-time recognition of deferred revenue in the second quarter of 2024, total revenues increased by $0.3 million, or 3% year over year to $10.0 million in the second quarter 2025. As a reminder, the one-time recognition of deferred revenue in the prior year was due to the termination of Licensing and Supply agreements. Including the deferred revenue recognized in the prior year, total revenues decreased to $10.0 million in the second quarter 2025 from $20.1 million in the second quarter 2024.

Manufacture and supply revenue increased to $9.6 million in the second quarter 2025 from $8.1 million in the second quarter 2024, primarily due to increases in Ondif revenues, partially offset by decreases in Suboxone revenues.

Research and development expenses in the second quarter 2025 remained relatively consistent compared to the second quarter 2024.

Selling, general and administrative expenses increased to $12.7 million in the second quarter 2025 from $11.4 million in the second quarter 2024. The increase primarily represents higher commercial spending of

------

approximately $2.0 million, higher regulatory and licensing fees of approximately $0.6 million related to the regulatory fee for Libervant, higher personnel costs of approximately $0.4 million, higher regulatory expenses related to Anaphylm of approximately $0.2 million, higher share-based compensation expenses of $0.2 million, and higher consulting fees of approximately $0.2 million, partially offset by lower legal fees of approximately $2.5 million and lower insurance expenses of $0.2 million.

Aquestive's net loss for the second quarter 2025 was $13.5 million, or $0.14 for both basic and diluted loss per share, compared to the net loss in the second quarter 2024 of $2.7 million, or $0.03 for both basic and diluted loss per share. Excluding the impact of one-time recognition of deferred revenue, the net loss in the second quarter 2024 was $13.2 million. The increase in net loss was primarily driven by decreases in revenues and increases in selling, general and administrative expenses, partially offset by increases in interest income and other income, net.

Non-GAAP adjusted EBITDA loss was $9.3 million in the second quarter 2025, compared to non-GAAP adjusted EBITDA income of $1.8 million in the second quarter 2024. Excluding the impact of one-time recognition of deferred revenue, non-GAAP adjusted EBITDA in the second quarter 2024 was a loss of $8.6 million.

Cash and cash equivalents were $60.5 million as of June 30, 2025.

**2025 Outlook**

Aquestive's full-year 2025 financial guidance is below.

The Company expects:

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| | |
|:---|:---|
| | **Guidance** |
| Total revenue (in millions) | $44 to $50 |
| Non-GAAP adjusted EBITDA loss (in millions) | $47 to $51 |

---

**Tomorrow's Conference Call and Webcast Reminder**

The Company will host a conference call at 8:00 a.m. ET on Tuesday, August 12, 2025.

In order to participate, please register in advance **here** to obtain a local or toll-free phone number and your personal pin.

A live webcast of the call will be available on Aquestive's website at: **Second Quarter 2025 Earnings Call.**

**About Anaphylm™**

Anaphylm™ (epinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug product candidate. Anaphylm is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The primary packaging for Anaphylm is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight. The Anaphylm trade name for AQST-109 has been conditionally approved by the FDA. Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate.

**About Libervant**<sup>®</sup>

Libervant<sup>®</sup> (diazepam) Buccal Film is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (*i.e.*, seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy. Aquestive developed Libervant as an alternative to the device-based products currently available for patients with refractory epilepsy, including a rectal gel and nasal spray products. The FDA approval for U.S. market access received in April 2024 for Libervant was for these epilepsy patients between two and five years of age. However, the FDA converted this approval to a "tentative approval" due to a recent court ruling finding that the FDA did not have authority to approve Libervant for U.S. market access for patients aged between two and five years due to the existing orphan drug market exclusivity granted by the FDA to an intranasal spray of another company. The FDA granted tentative approval in August 2022 for Libervant for

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treatment of these epilepsy patients twelve years of age and older. U.S. market access for Libervant patients is currently subject to the expiration of the existing orphan drug market exclusivity of the previously FDA approved drug scheduled to expire in January 2027.

**About AQST-108**

AQST-108 (epinephrine) Topical Gel is a topically delivered adrenergic agonist prodrug gel product candidate. Aquestive completed a first in human study for AQST-108 that measured the amount of epinephrine that remained on the skin or was found in circulation over time after the application of the gel. AQST-108 is based on Aquestive's AdrenaVerse™ platform that contains a library of over twenty epinephrine prodrug product candidates intended to control absorption and conversion rates across a variety of possible dosage forms and delivery sites.

**Important Safety Information**

Do not give Libervant to your child between the ages of two and five if your child is allergic to diazepam or any of the ingredients in Libervant or has an eye problem called acute narrow angle glaucoma.

**What is the most important information I should know about Libervant?**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**• Libervant is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death.** Get emergency help right away if any of the following happens:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**◦ shallow or slowed breathing,**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**◦ breathing stops (which may lead to the heart stopping),**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**◦ excessive sleepiness (sedation).**

**Do not allow your child to drive a motor vehicle, operate heavy machinery, or ride a bicycle until you know how taking Libervant with opioids affects your child.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Risk of abuse, misuse, and addiction.** Libervant is used in children 2 to 5 years of age. The unapproved use of Libervant has a risk for abuse, misuse, and addiction, which can lead to overdose and serious side effects including coma and death.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including diazepam (the active ingredient in Libervant).** These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. **Call your child's healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**◦ Your child can develop an addiction even if your child takes Libervant as prescribed by your child's healthcare provider.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**◦ Give Libervant exactly as your child's healthcare provider prescribed.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ Do not share Libervant with other people.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ Keep Libervant in a safe place and away from children.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Physical dependence and withdrawal reactions. Libervant is intended for use if needed in order to treat higher than usual seizure activity. Benzodiazepines**, including Libervant, can cause physical dependence and withdrawal reactions, especially if used daily. Libervant is not intended for daily use.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ **Do not suddenly stop giving Libervant to your child without talking to your child's healthcare provider.** Stopping Libervant suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures that will not stop (status epilepticus), sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, homicidal thoughts, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your child's healthcare provider or go to the nearest hospital emergency room right away if your child gets any of these symptoms.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ **Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months** including, anxiety, trouble remembering, learning, or

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concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning, or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ Physical dependence is not the same as drug addiction. Your child's healthcare provider can tell you more about the differences between physical dependence and drug addiction.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Do not give your child more Libervant than prescribed or give Libervant more often than prescribed.

**Libervant can make your child sleepy or dizzy and can slow your child's thinking and motor skills.** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Do not allow your child to drive a motor vehicle, operate machinery, or ride a bicycle until you know how Libervant affects your child.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Do not give other drugs that may make your child sleepy or dizzy while taking Libervant without first talking to your child's healthcare provider. When taken with drugs that cause sleepiness or dizziness, Libervant may make your child's sleepiness or dizziness much worse.

**Like other antiepileptic medicines, Libervant may cause suicidal thoughts or actions in a small number of people, about 1 in 500.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**• Call a healthcare provider right away if your child has any of these symptoms, especially if they are new, worse, or worry you:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ thoughts about suicide or dying

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ new or worse depression

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ feeling agitated or restless

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ trouble sleeping (insomnia)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ acting aggressive, being angry or violent

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ other unusual changes in behavior or mood

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ attempts to commit suicide

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ new or worse anxiety or irritability&nbsp;&nbsp;&nbsp;&nbsp;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ an extreme increase in activity and talking (mania)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ new or worse panic attacks

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ acting on dangerous impulses

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Keep all follow-up visits with your child's healthcare provider as scheduled.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Call your child's healthcare provider between visits as needed, especially if you are worried about symptoms.** Suicidal thoughts or actions can be caused by things other than medicines. If your child has suicidal thoughts or actions, your child's healthcare provider may check for other causes.

**What are the possible side effects of Libervant?**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The most common side effects of Libervant are sleepiness and headache.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• These are not all the possible side effects of Libervant.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA-1088.

For more information about Libervant, talk to your doctor, and see Product Information: Medication Guide and Instructions For Use.

**About Aquestive Therapeutics, Inc.**

Aquestive is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has four licensed commercialized products marketed by its licensees in the U.S. and around the world and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm<sup>®</sup>, and

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has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product candidate for the treatment of severe allergic reactions, including anaphylaxis, and an early-stage epinephrine prodrug topical gel product candidate for various possible dermatological conditions, including alopecia areata. For more information, visit Aquestive.com and follow us on LinkedIn.

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**Non-GAAP Financial Information**

This press release and our webcast earnings call regarding our quarterly financial results contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP adjusted EBITDA loss, non-GAAP adjusted gross margins, non-GAAP adjusted costs and expenses and other adjusted expense measures, because such measures exclude, as applicable, share-based compensation expense, interest expense, interest expense related to the sale of future revenue, interest income, depreciation, amortization, and income taxes.

Specifically, the Company adjusts net loss for certain non-cash expenses, including share-based compensation expenses; depreciation and amortization; and interest expense related to the sale of future revenue, interest income and other income, net and income taxes, with a result of non-GAAP adjusted EBITDA loss. Similarly, manufacture and supply expense, research and development expense, and selling, general and administrative expense were adjusted for certain non-cash expenses of share-based compensation expense and depreciation and amortization. Non-GAAP adjusted EBITDA loss and these non-GAAP expense categories are used as a supplement to the corresponding GAAP measures to provide additional insight regarding the Company's ongoing operating performance.

These measures supplement the Company's financial results prepared in accordance with GAAP. Aquestive management uses these measures to analyze its financial results, and its future manufacture and supply expenses, gross margins, research and development expense and selling, general and administrative expense and to help make managerial decisions. In management's opinion, these non-GAAP measures provide added transparency into the operating performance of Aquestive and added insight into the effectiveness of our operating strategies and actions. The Company may provide one or more revenue measures adjusted for certain discrete items, such as fees collected on certain licensed products, in order to provide investors added insight into our revenue stream and breakdown, along with providing our GAAP revenue. Such measures are intended to supplement, not act as substitutes for, comparable GAAP measures and should not be read as a measure of liquidity for Aquestive. Non-GAAP adjusted EBITDA loss and the other non-GAAP measures are also likely calculated in a way that is not comparable to similarly titled measures reported by other companies.

**Non-GAAP Outlook**

In providing the outlook for non-GAAP adjusted EBITDA and non-GAAP gross margin, we exclude certain items which are otherwise included in determining the comparable GAAP financial measures. In order to inform our outlook measures of non-GAAP adjusted EBITDA and non-GAAP gross margin, a description of the 2025 and 2024 adjustments which have been applicable in determining non-GAAP Adjusted EBITDA and non-GAAP gross margin for these periods are reflected in the tables below. In providing outlook for non-GAAP gross margin, the Company adjusts for non-cash share-based compensation expense and depreciation and amortization. The Company is providing such outlook only on a non-GAAP basis because the Company is unable to predict with reasonable certainty the totality or ultimate outcome or occurrence of these adjustments for the forward-looking period such as share-based compensation expense, income tax, amortization, and certain other adjusted items, which can be dependent on future events that may not be reliably predicted. Based on past reported results, where one or more of these items have been applicable, such excluded items could be material, individually or in the aggregate, to reported results.

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**Forward-Looking Statement**

Certain statements in this press release include "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believe," "anticipate," "plan," "expect," "estimate," "intend," "may," "will," or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of our product candidate Anaphylm™ (epinephrine) Sublingual Film through clinical development and approval by the FDA, including the filing and acceptance of the NDA for Anaphylm with the FDA, and the following commercial launch of Anaphylm, if approved by the FDA; the potential for an advisory committee for Anaphylm, if required by the FDA; timing of potential international regulatory filings and market approval of Anaphylm outside of the U.S.; that Anaphylm will be the first and only oral administration of epinephrine and accepted as an alternative to existing standards of care, if Anaphylm is approved by the FDA; the advancement, growth and related timing of our Adrenaverse™ pipeline of epinephrine prodrug product candidates, including AQST-108 (epinephrine) Topical Gel through clinical development and FDA regulatory approval; the potential benefits our products and product candidates could bring to patients; the achievement of clinical and commercial milestones; the impact of current and future potential tariffs on our commercial business; our future financial and operating results and financial position, including with respect to our 2025 financial outlook and estimated cash runway; and business strategies, market opportunities, and other statements that are not historical facts.

These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with our development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans, including those relating to Anaphylm, AQST-108, and our other product candidates; risk of delays in advancement of the regulatory approval process through the FDA of our product candidates, including for Anaphylm and AQST-108, or failure to receive FDA approval at all of any of these product candidates; risk of the Company's ability to generate sufficient clinical data for approval of our product candidates, including with respect to our pharmacokinetic and pharmacodynamic (PK/PD) comparability submission for FDA approval of Anaphylm; risks associated with our ability to address the FDA's comments on our NDA, including the risk that the FDA may require additional clinical studies for approval of Anaphylm; risks associated with the success of any competing products, including generics; risks and uncertainties inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risk of development of a sales and marketing capability for commercialization of our product candidates, including Anaphylm, Libervant and AQST-108; risks associated with the potential impact on the value of the Company of the sale or outlicensing of our product and product candidates, including Libervant and Anaphylm and other product candidates; risk of insufficient capital and cash resources, including insufficient access to available debt and equity financing, including under our ATM facility, and revenues from operations, to satisfy all of our short-term and longer-term liquidity and cash requirements and other cash needs, at the times and in the amounts needed, including to commence principal payments on our 13.5% Notes in 2026, and to fund future clinical development and commercial activities for our product candidates, should these product candidates be approved by the FDA; risk that our manufacturing capabilities will be insufficient to support demand of our product candidates in the U.S. and abroad, if approved by the FDA and other regulatory authorities, and our licensed products in the U.S. and abroad; risk of eroding market share for Suboxone® as a sunsetting product, which accounts for a substantial part of our current operating revenue; risk of default of our debt instruments; risks related to the outsourcing of certain sales, marketing and other operational and staff functions to third parties; risk of the rate and degree of market acceptance in the U.S. and abroad of Libervant, Anaphylm, AQST-108 and our other product candidates, should these product candidates be approved by the FDA and other regulatory authorities, and for our licensed products in the U.S. and abroad; risk associated with the size and growth of our product markets; risk associated with our compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to our products; risk that our patent applications for our product candidates, including for Anaphylm and AQST-108, will not be timely issued, or issued at all, by the U.S. Patent and Trademark Office; risk of unexpected patent developments; risk of legislation and regulatory actions and changes in laws or regulations affecting our business including relating to our products and product candidates and product pricing, reimbursement or access therefor; risk of loss of significant customers; risks related to claims and legal proceedings against us including patent infringement, securities, business torts, investigative, product safety or efficacy and antitrust litigation matters; risk

------

of product recalls and withdrawals; risks related to any disruptions in our information technology networks and systems, including the impact of cybersecurity attacks; risk of increased cybersecurity attacks and data accessibility disruptions due to remote working arrangements; risk of adverse developments affecting the financial services industry; risks related to inflation and changing interest rates; risks related to the impact of other pandemic diseases on our business; risks and uncertainties related to general economic, political (including the Ukraine and Israel wars and other acts of war and terrorism), business, industry, regulatory, financial and market conditions and other unusual items; risks related to uncertainty about presidential administration initiatives and their impact on our business, including imposition of tariffs and other trade restrictions; and other uncertainties affecting us including those described in the "Risk Factors" section and in other sections included in the Company's 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements or outlook or guidance after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by applicable law.

    

Libervant<sup>®</sup>, PharmFilm<sup>®</sup>, Sympazan<sup>®</sup> and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the property of their respective owners.

Investor inquiries:

Astr Partners

Brian Korb

brian.korb@astrpartners.com

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**AQUESTIVE THERAPEUTICS, INC.**

**Condensed Balance Sheets**

**(In thousands, except share and per share amounts)**

**(Unaudited)**

---

| | | |
|:---|:---|:---|
| | **June 30,<br>2025** | **December 31,<br>2024** |
| **Assets** | | |
| Current assets: |  |  |
| &nbsp;&nbsp;&nbsp;Cash and cash equivalents | $60536 | $71546 |
| &nbsp;&nbsp;&nbsp;Trade and other receivables, net | 11864 | 7344 |
| &nbsp;&nbsp;Inventories | 8125 | 6044 |
| &nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 1196 | 3286 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 81721 | 88220 |
| &nbsp;&nbsp;&nbsp;Property and equipment, net | 3858 | 3799 |
| &nbsp;&nbsp;&nbsp;Right-of-use assets, net | 4911 | 5182 |
| &nbsp;&nbsp;&nbsp;Other non-current assets | 3208 | 4223 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total assets | $93698 | $101424 |
| **Liabilities and stockholders' deficit** |  |  |
| Current liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;Accounts payable | $11951 | $10287 |
| &nbsp;&nbsp;&nbsp;Accrued expenses | 5001 | 5907 |
| &nbsp;&nbsp;&nbsp;Lease liabilities, current | 570 | 510 |
| &nbsp;&nbsp;&nbsp;Deferred revenue, current | 1092 | 1048 |
| &nbsp;&nbsp;&nbsp;Liability related to the sale of future revenue, current | 1000 | 1000 |
| &nbsp;&nbsp;&nbsp;Royalty obligations, current | 364 | 87 |
| &nbsp;&nbsp;&nbsp;Loans payable, current | 3177 | 26 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current liabilities | 23155 | 18865 |
| &nbsp;&nbsp;&nbsp;Notes payable, net | 31843 | 32500 |
| &nbsp;&nbsp;&nbsp;Royalty obligations, net | 22711 | 20129 |
| &nbsp;&nbsp;&nbsp;Liability related to the sale of future revenue, net | 61924 | 62718 |
| &nbsp;&nbsp;&nbsp;Lease liabilities | 4668 | 4968 |
| &nbsp;&nbsp;&nbsp;Deferred revenue, net of current portion | 19935 | 20005 |
| &nbsp;&nbsp;&nbsp;Other non-current liabilities | 2052 | 2395 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities | 166288 | 161580 |
| **Contingencies** |  |  |
| Stockholders' deficit: |  |  |
| &nbsp;&nbsp;Common stock, $0.001 par value. Authorized 250,000,000 shares; 99,353,270 and 91,413,742 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | 99 | 91 |
| &nbsp;&nbsp;&nbsp;Additional paid-in capital | 327003 | 302967 |
| &nbsp;&nbsp;&nbsp;Accumulated deficit | (399692) | (363214) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total stockholders' deficit | (72590) | (60156) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities and stockholders' deficit | $93698 | $101424 |

---

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**AQUESTIVE THERAPEUTICS, INC.**

**Condensed Statements of Operations and Comprehensive Loss**

**(In thousands, except share and per share data amounts)**

**(Unaudited)**

---

| | | | | |
|:---|:---|:---|:---|:---|
| | **Three Months Ended June 30,** | **Three Months Ended June 30,** | **Six Months Ended<br>June 30,** | **Six Months Ended<br>June 30,** |
| | **2025** | **2024** | **2025** | **2024** |
| Revenues | $10003 | $20099 | $18723 | $32152 |
| Costs and expenses: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Manufacture and supply | 4561 | 4526 | 8213 | 8915 |
| &nbsp;&nbsp;&nbsp;Research and development | 4105 | 4162 | 9466 | 10094 |
| &nbsp;&nbsp;&nbsp;Selling, general and administrative | 12705 | 11356 | 31777 | 22045 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total costs and expenses | 21371 | 20044 | 49456 | 41054 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Loss from operations | (11368) | 55 | (30733) | (8902) |
| Other income/(expenses): |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Interest expense | (2781) | (2779) | (5563) | (5563) |
| &nbsp;&nbsp;Interest expense related to royalty obligations | (1434) | (1358) | (2871) | (2716) |
| &nbsp;&nbsp;Interest expense related to the sale of future revenue | (61) | (58) | (120) | (116) |
| &nbsp;&nbsp;Interest income and other income, net | 2096 | 1395 | 2809 | 1724 |
| Net loss before income taxes | (13548) | (2745) | (36478) | (15573) |
| Net loss | $(13548) | $(2745) | $(36478) | $(15573) |
| Comprehensive loss | $(13548) | $(2745) | $(36478) | $(15573) |
| **Loss per share attributable to common stockholders:** |  |  |  |  |
| Basic and diluted (in dollars per share) | $(0.14) | $(0.03) | $(0.37) | $(0.19) |
| **Weighted average common shares outstanding:** |  |  |  |  |
| Basic and diluted (in shares) | 99326701 | 90911626 | 97422458 | 82263168 |

---

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**AQUESTIVE THERAPEUTICS, INC.**

**Reconciliation of Non-GAAP Adjustments - Net Loss to Non-GAAP Adjusted EBITDA**

**(In Thousands)**

**(Unaudited)** 

---

| | | | | |
|:---|:---|:---|:---|:---|
| | **Three Months Ended June 30,** | **Three Months Ended June 30,** | **Six Months Ended<br>June 30,** | **Six Months Ended<br>June 30,** |
| | **2025** | **2024** | **2025** | **2024** |
| GAAP net loss | $(13548) | $(2745) | $(36478) | $(15573) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Share-based compensation expense | 1884 | 1539 | 3471 | 3119 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Interest expense | 2781 | 2779 | 5563 | 5563 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Interest expense related to royalty obligations | 1434 | 1358 | 2871 | 2716 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Interest expense related to the sale of future revenue | 61 | 58 | 120 | 116 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Interest income and other income, net | (2096) | (1395) | (2809) | (1724) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Depreciation and Amortization | 140 | 205 | 279 | 412 |
| Total non-GAAP adjustments | $4204 | $4544 | $9495 | $10202 |
| Non-GAAP adjusted EBITDA | $(9344) | $1799 | $(26983) | $(5371) |
| Excluding Non-GAAP adjusted R&D expenses | (3681) | (3836) | (8697) | (9578) |
| Non-GAAP adjusted EBITDA excluding Non-GAAP adjusted R&D expenses | $(5663) | $5635 | $(18286) | $4207 |

---

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**AQUESTIVE THERAPEUTICS, INC.**

**Reconciliation of Non-GAAP Adjustments - GAAP Expenses to Non-GAAP Adjusted Expenses**

**(In Thousands, except percentages)**

**(Unaudited)** 

---

| | | | | |
|:---|:---|:---|:---|:---|
| | **Three Months Ended<br>June 30,** | **Three Months Ended<br>June 30,** | **Six Months Ended<br>June 30,** | **Six Months Ended<br>June 30,** |
| | **2025** | **2024** | **2025** | **2024** |
| **Total costs and expenses** | $21371 | $20044 | $49456 | $41054 |
| &nbsp;&nbsp;&nbsp;Non-GAAP adjustments: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Share-based compensation expense | (1884) | (1539) | (3471) | (3119) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Depreciation and amortization | (140) | (205) | (279) | (412) |
| **Non-GAAP adjusted costs and expenses** | $19347 | $18300 | $45706 | $37523 |
| **Manufacture and Supply Expense** | $4561 | $4526 | $8213 | $8915 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*Gross Margin on total revenue* | *54 %* | *77 %* | *56 %* | *72 %* |
| &nbsp;&nbsp;&nbsp;Non-GAAP adjustments: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Share-based compensation expense | (128) | (99) | (228) | (169) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Depreciation and amortization | (112) | (176) | (227) | (352) |
| **Non-GAAP adjusted manufacture and supply expense** | $4321 | $4251 | $7758 | $8394 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*Non-GAAP Gross Margin on total revenue* | *57 %* | *79 %* | *59 %* | *74 %* |
| **Research and Development Expense** | $4105 | $4162 | $9466 | $10094 |
| &nbsp;&nbsp;&nbsp;Non-GAAP adjustments: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Share-based compensation expense | (408) | (308) | (738) | (478) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Depreciation and amortization | (16) | (18) | (31) | (38) |
| **Non-GAAP adjusted research and development expense** | $3681 | $3836 | $8697 | $9578 |
| **Selling, General and Administrative Expenses** | $12705 | $11356 | $31777 | $22045 |
| &nbsp;&nbsp;&nbsp;Non-GAAP adjustments: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Share-based compensation expense | (1348) | (1132) | (2505) | (2472) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Depreciation and amortization | (12) | (11) | (21) | (22) |
| **Non-GAAP adjusted selling, general and administrative expenses** | $11345 | $10213 | $29251 | $19551 |

---

## Exhibit 99.2

![](q22025supplementalearnin001.jpg)

Advancing medicines. Solving problems. Improving lives. September 2024 Second Quarter 2025 Earnings Supplemental Materials August 11, 2025

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![](q22025supplementalearnin002.jpg)© 2025 Aquestive Therapeutics, Inc. 2 Disclaimer Certain statements in this press release include "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believe," "anticipate," "plan," "expect," "estimate," "intend," "may," "will," or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of our product candidate Anaphylm (epinephrine) Sublingual Film through clinical development and approval by the FDA, including the filing and acceptance of the NDA for Anaphylm with the FDA, and the following launch of Anaphylm, if approved by the FDA; the potential for an advisory committee for Anaphylm, if required by the FDA; timing of potential international regulatory filings for Anaphylm and market approval outside of the U.S. for our product candidate Libervant; the advancement, growth and related timing of our Adrenaverse pipeline of epinephrine prodrug product candidates, including AQST-108 (epinephrine) Topical Gel through clinical development and FDA regulatory approval process; the potential benefits our products and product candidates could bring to patients; the achievement of clinical and commercial milestones; our future financial and operating results and financial position, including with respect to our 2025 financial outlook and estimated cash runway; and business strategies, market opportunities, and other statements that are not historical facts. These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with our development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans, including those relating to Anaphylm, AQST-108, and our other product candidates; risk of delays in advancement of the regulatory approval process through the FDA of our product candidates, including the filing and acceptance of the respective NDAs, for Anaphylm, AQST-108 or failure to receive FDA approval at all of any of these product candidates; risk of the Company's ability to generate sufficient clinical data for approval of our product candidates, including with respect to our PK/PD comparability submission for FDA approval of Anaphylm; risks associated with our ability to address the FDA's comments on our future clinical trials, including the risk that the FDA may require additional clinical studies for approval of Anaphylm; risks associated with the success of any competing products, including generics; risks and uncertainties inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risk of development of a sales and marketing capability for commercialization of our product candidates, including Anaphylm and AQST-108; risks associated with the potential impact on the value of the Company of the sale or outlicensing of our product and product candidates, including Libervant and Anaphylm and other product candidates; risk of insufficient capital and cash resources, including insufficient access to available debt and equity financing, including under our ATM facility, and revenues from operations, to satisfy all of our short-term and longer-term liquidity and cash requirements and other cash needs, at the times and in the amounts needed to fund future clinical development and commercial activities for our product candidates; risk that our manufacturing capabilities will be insufficient to support demand, should Libervant receive U.S. market access, and for demand for our licensed products in the U.S. and abroad; risk of eroding market share for Suboxone® as a sunsetting product, which accounts for a substantial part of our current operating revenue; risk of default of our debt instruments; risks related to the outsourcing of certain sales, marketing and other operational and staff functions to third parties; risk of the rate and degree of market acceptance in the U.S. and abroad of Libervant, Anaphylm, AQST-108 and our other product candidates, should these product candidates be approved by the FDA, and for our licensed products in the U.S. and abroad; risk associated with the size and growth of our product markets; risk associated with our compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to our products; risk that our patent applications for our product candidates, including for Anaphylm and AQST-108, will not be timely issued, or issued at all, by the U.S. Patent and Trademark Office; risk of unexpected patent developments; risk of legislation and regulatory actions and changes in laws or regulations affecting our business including relating to our products and product candidates and product pricing, reimbursement or access therefor; risk of loss of significant customers; risks related to claims and legal proceedings against us including patent infringement, securities, business torts, investigative, product safety or efficacy and antitrust litigation matters; risk of product recalls and withdrawals; risks related to any disruptions in our information technology networks and systems, including the impact of cybersecurity attacks; risk of increased cybersecurity attacks and data accessibility disruptions due to remote working arrangements; risk of adverse developments affecting the financial services industry; risks related to inflation and changing interest rates; risks related to the impact of other pandemic diseases on our business; risks and uncertainties related to general economic, political (including the Ukraine and Israel wars and other acts of war and terrorism), business, industry, regulatory, financial and market conditions and other unusual items; risks related to uncertainty about presidential administration initiatives and their impact on our business, including imposition of tariffs and other trade restrictions; and other uncertainties affecting us including those described in the "Risk Factors" section and in other sections included in the Company's 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements or outlook or guidance after the date of this presentation whether as a result of new information, future events or otherwise, except as may be required by applicable law. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy any of the Company's securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. PharmFilm®, Libervant® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. The trade name "Anaphylm" for AQST-109 has been conditionally approved by the FDA. Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate, AQST-109. All other registered trademarks referenced herein are the property of their respective owners.

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![](q22025supplementalearnin003.jpg)

3 Q2 2025 earnings key messages Anaphylm (epinephrine) Sublingual Film for severe allergic reactions, including anaphylaxis • FDA accepted the NDA in Q2 2025; PDUFA date is scheduled for January 31, 2026 • Preparing for a U.S. launch in Q1 2026, if approved by FDA • Established team with significant experience in the allergy space • Expanding awareness of Anaphylm with Health Care Professionals (HCPs) • Continuing critical work with payers to raise awareness and prepare for launch • Actively engaging with advocacy groups • Continue to focus on global expansion – • Meeting with Health Canada in September of 2025 and • Submitted an initial briefing book to the European Medicines Agency Strong balance sheet with projected cash runway into 2026 • As of June 30, 2025, the Company had a cash balance of approximately $60.5 million

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![](q22025supplementalearnin004.jpg)

4 Upcoming expected key milestones AQST – 108 Libervant® Q2 2025 Q3 2025 Q4 2025 Q1 2026 AnaphlymTM Open IND NDA Accepted Potential Advisory Committee Meeting Potential licensee-led ex-U.S. Approval Filings Meeting with Health Canada PDUFA action date is scheduled for January 31, 2026Initial briefing book submitted to EMA Potential ex-U.S. Approval Filings

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![](q22025supplementalearnin005.jpg)

Anaphylm Pediatric Study Results

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![](q22025supplementalearnin006.jpg)

6 Primary objective: • To evaluate the epinephrine pharmacokinetics (PK) following administration of Anaphylm in pediatric participants from the ages of 7 to 17 weighing ≥30 kg Secondary objectives: • To evaluate the following in pediatric participants from the ages of 7 to 17 weighing ≥30 kg: • Safety and tolerability of Anaphylm • Epinephrine pharmacodynamics (PD) following administration of Anaphylm Pediatric study objectives

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![](q22025supplementalearnin007.jpg)

71. Aquestive Therapeutics, Inc. data on file. Cross Study Epinephrine Pharmacokinetic (PK) Comparison of Adult (AQ109301) and Pediatric (AQ109302) Anaphylm Studies Takeaway: 12 mg Anaphylm administration demonstrated comparable PK curves in adult and pediatric subjects. • While the study goals were PK descriptive in nature, cross study statistical evaluation showed no statistical differences between PK parameters

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![](q22025supplementalearnin008.jpg)

8 Baseline-corrected epinephrine plasma Pharmacokinetic (PK) parameters¹ Parameter Unit Overall² (N=29) Cmax pg/mL 568.6 (175.8) AUC0-10 h\*pg/mL 24.7 (183.1) [n=27] AUC0-20 h\*pg/mL 73.8 (153.5) [n=27] AUC0-30 h\*pg/mL 114.5 (138.8) [n=28] AUC0-45 h\*pg/mL 147.8 (109.9) 1. Aquestive Therapeutics, Inc. data on file. 2. Data are geometric means with a coefficient of variation (CV) percentage. • Study (N= 32) was powered based on similarity between pediatric and adult populations • The parameters shown were evaluated and there was no statistical difference between the PK outcome in pediatric compared to adult population (302vs 301)

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![](q22025supplementalearnin009.jpg)

9 Cross Study Pharmacodynamic (PD) Comparison of Adult (AQ109301) and Pediatric (AQ109302) of Anaphylm Studies¹ 1. Aquestive Therapeutics, Inc. data on file. 2. AUEC and Emax are mean. • The study demonstrated, directionally, a similar pharmacodynamic response with elevation of SBP, DBP and HR in the pediatric subjects after dosing² • The magnitude of these changes in pediatric subjects appear somewhat lower than in adults but are directionally the same

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![](q22025supplementalearnin010.jpg)

10 Pharmacodynamic (PD) outcomes¹ Parameter Unit Overall (N=32) Heart Rate² Emax bpm 12.5 (17.3) TEmax (median) min 12.0 AUEC0-60 h\*bpm 5.9 (7.8) [n=31] Systolic Blood Pressure² Emax mmHg 15.4 (12.3) TEmax (median) min 11.0 AUEC0-60 h\*mmHg 8.7 (8.6) Diastolic Blood Pressure² Emax mmHg 9.8 (13.6) TEmax (median) min 8.0 AUEC0-60 h\*mmHg 3.6 (6.0) [n=31] 1. Aquestive Therapeutics, Inc. data on file. . 2. AUEC and Emax date are mean (SD). • As illustrated on the prior slide and denoted here, the direction remains positive • HR, SBP and DBP have a positive inflection after Anaphylm exposure • DBP, as seen in all prior studies, has a similar positive inflection in the pediatric study

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![](q22025supplementalearnin011.jpg)

Second Quarter Results

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![](q22025supplementalearnin012.jpg)

12 Positioned to meet near-term milestones with projected cash runway into 2026 $77.9 $93.0 $68.7 $60.5 0 20 40 60 80 100 120 Q3 24 Q4 24 Q1 25 Q2 25 U SD (M illi on s) Ending Cash Balance by Quarter

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13 36,863 33,458 47,953 46,241 45,328 42,516 34,418 43,818 43,032 27,392 37,204 0 10,000 20,000 30,000 40,000 50,000 60,000 Q4 22 Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 D O SE S SH IP PE D (0 00 'S) QUARTER Doses Shipped by Quarter Manufacturing operations continue to generate cash

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14 2025 guidance as of August 11, 2025 2025 Outlook • Total revenues of approximately $44-$50 million • Non-GAAP adjusted EBITDA loss of approximately $47-$51 million

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Thank You

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## Exhibit 99.3

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Advancing medicines. Solving problems. Improving lives. September 2024 Corporate Presentation August 2025

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![](aquestive_corppresentati002.jpg)© 2025 Aquestive Therapeutics, Inc. 2 Disclaimer This presentation and the accompanying oral commentary have been prepared by Aquestive Therapeutics, Inc. ("Aquestive", the "Company", "our" or "us") and contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believe," "anticipate," "plan," "expect," "estimate," "intend," "may," "will," or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of our product candidate Anaphylm (epinephrine) Sublingual Film through clinical development and approval by the U.S. Food and Drug Administration (FDA), including the timing of acceptance of the New Drug Application (NDA) for Anaphylm by the FDA, potential for an advisory committee meeting and regulatory submissions outside the U.S.; and the following pre-launch activities and commercial launch of Anaphylm, if approved by the FDA; that the results of the Company's clinical studies and data for Anaphylm are sufficient to support submission of the NDA for approval of Anaphylm by the FDA; that Anaphylm will be the first and only oral administration of epinephrine and accepted as an alternative to existing standards of care, if Anaphylm is approved by the FDA; the expected growth of the U.S. epinephrine market including in value and the opportunity such growth presents to the Company should Anaphylm be approved by the FDA; the advancement, growth and related timing of our Adrenaverse pipeline epinephrine prodrug product candidates, including AQST-108 (epinephrine) Topical Gel; through clinical development including design and timing of clinical studies including those necessary to support the targeted indication of moderate and severe alopecia areata for AQST-108, if approved by the FDA; plans and timing to submit the IND for AQST-108 and initiation of a Phase 2a clinical trial for AQST-108 for the treatment of patients with alopecia areata; following launch of AQST-108, if approved by the FDA; the launch of Libervant if approved by the FDA for U.S. market access for ARS epilepsy patients; the commercial opportunity of Libervant, Anaphylm, and AQST-108, including potential market growth and revenues (including projected peak annual sales) generated for the Company from commercialization of these products and product candidates should Anaphylm and AQST-108 be approved by the FDA and Libervant gain U.S. market access; the potential benefits our products and product candidates could bring to patients and acceptance by patients, prescribers and payors of our product candidates as an alternative to existing standards of care for the targeted medical indication of these product candidates; and business strategies, market opportunities, and other statements that are not historical facts. These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with our development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans, including those relating to Anaphylm, AQST-108, and our other product candidates, or failure to receive FDA approval at all for these and other product candidates; risk of delays in advancement of the regulatory approval process through the FDA of our product candidates, including the acceptance of the NDA for Anaphylm; the risk of whether the Company's clinical data is sufficient for approval of Anaphylm, including with respect to our pharmacokinetic (PK) and pharmacodynamic (PD) comparability submission for FDA approval of Anaphylm; risks associated our ability to address the FDA's comments on our clinical trials and other concerns identified in the FDA Type C meeting minutes for Anaphylm, including the risk that the FDA may require additional clinical studies for approval of Anaphylm; risk of U.S. market access for Libervant upon expiration of the seven year orphan drug market exclusivity granted by the FDA for an approved nasal spray product of another company, which is scheduled to occur in January 2027, or for other reasons; risks associated with the success of any competing products, including generics; risks and uncertainties inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risk of development of a market access, sales and marketing capability for commercialization of our product candidates, including Libervant, Anaphylm and AQST-108; risks associated with the potential impact on the value of the Company of the sale or outlicensing of our product and product candidates, including Libervant and Anaphylm and other product candidates; risk of insufficient capital and cash resources, including insufficient access to available debt and equity financing, including under our ATM facility, and revenues from operations, to satisfy all of our short-term and longer-term liquidity and cash requirements and other cash needs, at the times and in the amounts needed, including to commence principal payments on our 13.5% Notes in 2026 and to fund future clinical development and commercial activities for our product candidates, including Anaphylm and AQST-108, should these product candidates be approved by the FDA, and for the launch of Libervant upon expiration of the orphan drug marketing exclusivity period of the nasal spray product, if granted by the FDA; risk that our manufacturing capabilities will be insufficient to support demand for Libervant should Libervant receive U.S. market access, and for demand for our licensed products in the U.S. and abroad; risk of eroding market share for Suboxone® as a sunsetting product, which accounts for a substantial part of our current operating revenue; risk of default of our debt instruments; risks related to the outsourcing of certain sales, marketing and other operational and staff functions to third parties; risks associated with the rate and degree of market acceptance in the U.S. and abroad of our product candidates, including Libervant and Anaphylm, if approved by the FDA; risk of the rate and degree of market acceptance in the U.S. and abroad of our licensed products; risk associated with the size and growth of our product markets; risk associated with our compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to our products; risk that our patent applications for our product candidates, including for Anaphylm, will not be timely issued, or issued at all, by the United States Patent and Trademark Office (PTO); risk of unexpected patent developments; risk of legislation and regulatory actions and changes in laws or regulations affecting our business including relating to our products and product candidates and product pricing, reimbursement or access therefor; risk of loss of significant customers; risks related to claims and legal proceedings against us including patent infringement, securities, business torts, investigative, product safety or efficacy and antitrust litigation matters; risk of product recalls and withdrawals; risks related to any disruptions in our information technology networks and systems, including the impact of cybersecurity attacks; risk of increased cybersecurity attacks and data accessibility disruptions due to remote working arrangements; risk of adverse developments affecting the financial services industry; risks related to inflation and changing interest rates; risks related to the impact of pandemic diseases on our business; risks and uncertainties related to general economic, political (including the Ukraine and Israel wars and other acts of war and terrorism), business, industry, regulatory, financial and market conditions and other unusual items, including a potential recession; risks related to uncertainty about U.S. government initiatives and their impact on our business, including imposition of tariffs and other trade restrictions; and other uncertainties affecting us including those described in the "Risk Factors" section and in other sections included in the Company's 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements or outlook or guidance after the date of this presentation whether as a result of new information, future events or otherwise, except as may be required by applicable law. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy any of the Company's securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. PharmFilm® Libervant and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. The trade name "Anaphylm" for AQST-109 has been conditionally approved by the FDA. Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate, AQST-109. All other registered trademarks referenced herein are the property of their respective owners.

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3 A publicly traded pharmaceutical company (NASDAQ: AQST) focused on advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. Who we are…

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6 of revenue in 2024 150+ 20+ years since the company was founded Products available in6 continents Over $1.5 billion1 in potential peak annual net sales from pipeline assets drug approvals 1.Aquestive Therapeutics data on file. 2.5 billion $57M+ PharmFilm® doses shipped worldwide More than employees based in Indiana and New Jersey expected in the U.S. by 2027 2product launches 4

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5 Our Technologies AdrenaVerseTM platform contains a library of over 20 epinephrine prodrugs that demonstrate control of absorption and conversion rates across a variety of dosage forms including lotions, creams, and ointments (LCOs) and delivery sites. The AdrenaVerse platform enables us to pursue a variety of allergy and dermatological indications. PharmFilm® PharmFilm® is a unique and versatile technology for high-performance drug delivery. Aquestive scientists combine the customizable features of PharmFilm® with patented formulation and engineering processes to optimize the delivery of active pharmaceutical ingredients (APIs). TM

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6 Aquestive is the go-to formulation development and commercial manufacturing partner for oral thin film products worldwide Our Products 1. Ondif collaboration with Hypera-Pharma (Brazil). 2. Sympazan collaboration with Otter Pharmaceuticals (worldwide). 3. Emylif collaboration with Zambon (EU). 4. Suboxone collaboration with Indivior (worldwide). Validation from 4 licensed commercial products,1-4 supplying over 95% of the world's prescription oral thin films

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7 Anaphylm (epinephrine) Sublingual Film (SEVERE ALLERGIES, ANAPHYLAXIS) PDUFA action date is scheduled for January 31, 2026 Libervant® (diazepam) Buccal Film (ACUTE REPETITIVE SEIZURES) AQST-108 (epinephrine) Topical Gel (ALOPECIA AREATA) Diversified Pipeline Fuels Our Growth Plan 1. Aquestive Therapeutics data on file. 2. Annual revenue includes revenue for patients ages 2-5 and 12 and up after launch in 2027. Proprietary Growth Drivers Preclinical Clinical Filed Marketed Opportunity Size >$500M1 Annual Revenue >$1B1 Annual Revenue >$100M2 Annual Revenue

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8 Cassie Jung Chief Operating Officer Dedicated and Experienced Leadership Team Daniel Barber President, CEO & Director Lori J. Braender Chief Legal Officer, Chief Compliance Officer, Corporate Secretary Ernie Toth Chief Financial Officer Peter Boyd SVP, HR & IT Melina Cioffi SVP, Regulatory Affairs Carl Kraus Chief Medical Officer Sherry Korczynski Chief Commercial Officer

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Lead Asset Anaphylm (epinephrine) Sublingual Film

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10 A Novel Approach to Epinephrine Delivery First and only non-device based, orally delivered epinephrine product candidate Needle-Free Easy to Administer Delay-Free Works Quickly1 Device-Free Easy to Carry + + Anaphylm (epinephrine) Sublingual Film 1. Aquestive Therapeutics data on file.

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11 Anaphylaxis: A rapid-onset, life-threatening allergic reaction requiring immediate intervention 1. Xiaowei Liu , Sangil Lee , Christine M Lohse , Cassandra T Hardy , Ronna L Campbell Biphasic Reactions in Emergency Department Anaphylaxis Patients: A Prospective Cohort Study, DOI: 10.1016/j.jaip.2019.10.027 2. Shaw, Maggie L, Gaps in Anaphylaxis Care, Epinephrine Use Highlight Resource Need, Nov. 6, 2021. Anaphylaxis signs & symptoms (minutes to hours)1,2 Allergen Exposure LI KE LI H O O D O F O C C U RR EN C E INITIAL REACTION 5m 10m 15m 20m 25m 30m 1h 8h 72h2h 3h 4h 5h 6h 7h 9h 10hTIME During an allergic reaction, time is the enemy 30+ minute delay = Triple risk.1 73.6% do not receive epinephrine before ER visit2 Benefits of epinephrine far outweigh the risks2

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12 Anaphylaxis is on the Rise—and so are the Risks 1. Gupta RS, et al. Pediatrics. 2011. 2. Gupta RS, et al. Pediatrics 2018. 3. McGowan EC, et al. J Clin Allergy Immunol. 2013. 4. Jackson KD, et al. NCHS Data Brief. 2013. 5. Black LI, et al. CDC National Center for Health Statistics Data Brief. 2019. 6. Gupta RS, et al. JAMA Netw Open. 2019. 7. Verrill L, et al. Allergy Asthma Pro. 2015. 8. Bilo BM, et al. Current Opin Allergy Clin Immunol. 2008. 9. IQVIA Claims Data, 2023. 10. Death From Anaphylaxis Is a Reassuringly Unusual Outcome Borish, Larry et al. Journal of Allergy and Clinical Immunology, Volume 133, Issue 2, AB234 11. Aquestive Therapeutics data on file. Epidemiology prevalence data estimates ~40M patients with type 1 allergic reactions1-8 ~20M patients diagnosed and under physician care from 2020 to 20239 ~5M scripts for epinephrine were filled in 202411 ~100 deaths per year in the U.S. due to anaphylaxis10 M O R TA L I T Y R AT E : 0.3% of anaphylaxis-related hospitalizations 10

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13 U.S. Market has the Potential to Grow to ~$2B in Value by 20311 Current Market Size (2024)²: ~$800M Projected Market Size (2031): ~$2B 15% CAGR from 2021 to 2023 3,164 3,260 3,048 3,975 4,000 4,671 4,940 0 500 1,000 1,500 2,000 2,500 3,000 3,500 4,000 4,500 5,000 2018A 2019A 2020A 2021A 2022A 2023A 2024A Epinephrine Market TRx Count (000s) 2018-2020 Baseline 3,158 1. Aquestive Therapeutics data on file, scripts written for epinephrine auto-injectors(EAIs) have increased at a 15% compound annual growth rate (CAGR) from 2021- 2023. 2. Aquestive Therapeutics data on file, Precedence Research, "Epinephrine Market Size, Share and Trends 2025-2034". Market is expanding due to: Increasing prevalence of allergies Increased Patient Awareness Demand for Better solutions

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14 Top Reasons Why People Don't Carry Epinephrine Autoinjectors (EAI) Devices1 1. https://community.kidswithfoodallergies.org/blog/new-epinephrine-study-shows-alarming-results; survey results reflect EAIs only. 2.Fromer L., The American Journal of Medicine (2016) 129, 1244-1250. Inconvenience of carrying bulky devices Forgetfulness Device malfunctions and improper administration Fear of needles and social stigma Availability at other places, such as the home, car or school Expiration of the previous prescription Complacency, if there has been no accidental exposure in a long time Where you need it, when you need it - less than 50% of patients carry their EpiPen®²

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15 Rapid Relief When It Matters Most1 Anaphylm reaches peak absorption in just 12 minutes Achieves therapeutic blood concentrations in as little as 5 minutes (over 100 pg/ml) Consistently delivers a median T-max of 12 minutes 1. Aquestive Therapeutics, Inc. data results on file, excluding T-max data results for Neffy®, which can be found in the prescribing information located in the approved product label; no head-to-head comparison studies have been conducted with Anaphylm and Neffy®.

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16 Film Dosing Option Preference – Patients and HCPs1 80% prefer a non-injection dosing method 95% are interested in a film-dosing option P A T I E N T S A N D C A R E G I V E R S 95% believe a film-dosing option fills an unmet need in the epinephrine market 85% indicated they would Rx a film-dosing option H E A L T H C A R E P R O V I D E R S 1. Aquestive Therapeutics, Inc. data on file.

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17 Anaphylm Key Milestones Pediatric Study Completed Q1 2025 NDA Submission Completed NDA Accepted by the FDA Potential ex-US Approval Filings Potential Advisory Committee Meeting Q2 2025 Q3 2025 Q4 2025 Q1 2026 PDUFA action date is scheduled for January 31, 2026

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18 2024 2025 2026 Anaphylm go-to market activities Strategic Foundations • Key opinion leader engagement • Market research with >1,000 HCPs, patients, caregivers, and payors • Partnering with epinephrine- experienced promotional agencies and commercial consultants Launch Readiness • Continue to increase awareness of Anaphylm • Talent acquisition • Continue to execute our go- to-market plan driving awareness oKnown epinephrine prescribers/specialties oWork with payers to raise awareness oEngagement with advocacy groups oCongress attendance oPublications Preparedness for Commercial Launch • Facilitate access with payers • Focus on key prescribers in the initial launch • Leverage Anaphylm's unique product attributes to engage HCPs, patients, caregivers, and advocacy groups • Optimize marketing mix that works smarter, is more focused to enable us to effectively compete in the epinephrine delivery market

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Pipeline Products

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20 z AQST-108 (epinephrine) Topical Gel 1. Jeong, W.Y., Kwon, M., Choi, H.E. et al. Recent advances in transdermal drug delivery systems: a review. Biomater Res 25, 24 (2021). 2. Aquestive Therapeutics data on file. 3. See Investor Day Presentation dated September 27, 2024, located at Aquestive.com/investors/eventsandpresentations for more detail on clinical development and the commercial overview. H U M A N S K I N S T R U C T U R E The utility of exogeneous epinephrine for the treatment of medical conditions has been limited due to the molecule's five-minute half-life as well as poor absorption capabilities¹ Aquestive's AdrenaVerse technology has the potential to address both problems² Completed First-in-Human Study (FIH) Pursuing alopecia areata (AA) as a potential initial indication³

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21 Alopecia Areata Represents a Potentially Significant Opportunity¹ R E A S O N S T O B E L I E V E Patient unmet need is well- documented and understood Planned development endpoints that are potentially achievable Competitive landscape indicates pricing will continue to be reasonable Commercial opportunity can fit within a growing Aquestive commercial infrastructure I N I T I A L T A R G E T P R O D U C T P R O F I L E ² Description • Topical gel form of AQST-108 Indication • Moderate and severe alopecia areata patients Dosage and Administration • Apply once in the morning and once at night Safety • Potential for no black box warning Value Proposition • May be an alternative to using janus kinase (or JAK) inhibitors • May improve treatment for the two-thirds of severe patients who see no improvement with JAK inhibitors¹ • May improve treatment in conjunction with JAK inhibitors 1. Aquestive Therapeutics data on file. 2. Dependent on final clinical and regulatory outcomes.

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22 120% Annual Growth Estimated $1 billion+ opportunity for JAK inhibitors¹ 6k 9k 13k 15k 18k 21k 23k 26k 29k - 5,000 10,000 15,000 20,000 25,000 30,000 2022-Q2 2022-Q3 2022-Q4 2023-Q1 2023-Q2 2023-Q3 2023-Q4 2024-Q1 2024-Q2 P R E S C R IP T IO N C O U N T Olumiant and Litfulo Prescriptions by Quarter 1. Aquestive Therapeutics data on file. Olumiant FDA label approval Litfulo FDA label approval Olumiant label for AA granted in June 2022 Litfulo label for AA granted in June 2023 Combined prescriptions for Olumiant and Litfulo in 2nd quarter of 2024 totaled ~30K, representing a small fraction of the severe AA patient population This still represents a small fraction of the patient prevalence for severe AA, for which awareness is building

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23 AQST-108 Planned Phase 2a Clinical Study for Alopecia Areata¹ Phase 2a Study Design 36 subjects, 3 doses 12 – 24 weeks² Early Responder Rate (ERR) of 10% - early responder defined as a subject with 20% improvement in Severity of Alopecia Tool (SALT)³ from baseline at week 12 Proportion of subjects achieving either a SALT score of ≤ 10 (SALT10) or achieving at least a 50% reduction in absolute SALT score from baseline at week 24 1. Plan on commencing study after alignment with the FDA on the protocol. 2. Interim data expected to be available after 12 weeks and primary endpoint data expected to be available at 24 weeks. 3. The Severity of Alopecia Tool is a standardized system used to quantify hair loss in Alopecia Areata (AA) cases. A Phase 2a, multi- center, double-blind, dose-response, adaptive study to evaluate the safety and efficacy of AQST-108 in patients with moderate alopecia areata

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24 Planned AQST-108 Clinical and Regulatory Approval Timeline Q4 2025 Q1 2026 Q2 2026 Q3 2026 Expect to Open IND Expected Phase 2bExpected Phase 2a

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Thank You

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