Project Academy Corporate Presentation Strictly Confidential. Do Not Distribute.
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. We obtained the industry, market and competitive position data used throughout this presentation from our own internal estimates and research, as well as from industry and general publications, and research, surveys and studies conducted
by third parties. Internal estimates are derived from publicly available information released by industry analysts and third-party sources, our internal research and our industry experience, and are based on assumptions made by us based on such
data and our knowledge of the industry and market, which we believe to be reasonable. In addition, while we believe the industry, market and competitive position data included in this presentation is reliable and based on reasonable
assumptions, we have not independently verified any third-party information, and all such data involve risks and uncertainties are subject to change based on various factors. This data involves a number of assumptions and limitations, and you
are cautioned not to give undue weight to such estimates. An effective shelf registration statement on Form S-3 was filed with the SEC. The offering of these securities will be made only by means of a prospectus supplement and base prospectus
forming part of the effective registration statement relating to the shares. You may obtain these documents and other documents incorporated by reference or filed as exhibits to the registration statement for more complete information about
this offering. Copies of the prospectus supplement for this offering may also be obtained, when available, by contacting Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800)
808-7525 ext. 6105, or by email at syndicate@leerink.com Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022; or by e-mail at prospectus@cantor.com. 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. Strictly Confidential. Do Not Distribute.
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… Strictly Confidential. Do Not Distribute.
6 of revenue in 2024 150+ 20+ years since the company was founded Products
available in 6 continents drug approvals 2.5 billion $57M+ PharmFilm® doses shipped worldwide More than employees based in Indiana and New Jersey expected in the U.S. by 2027 if approved by the FDA 2 product launches 4 Strictly
Confidential. Do Not Distribute.
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 Strictly Confidential. Do Not Distribute.
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 products1-4 Strictly Confidential. Do Not Distribute.
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 Proprietary Growth
Drivers Preclinical Clinical Filed Marketed Strictly Confidential. Do Not Distribute.
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 Strictly Confidential. Do Not Distribute.
Revenue Interest Purchase and Sales Agreement Strictly Confidential. Do Not
Distribute.
An affiliate of RTW (the “Purchaser”) has agreed to enter into a $75M revenue
interest purchase and sale agreement (the “RIPSA”) with Aquestive with substantially the following terms: Funding is contingent upon both FDA approval of Anaphylm (with a January 31, 2026 scheduled PDUFA date) and refinancing of Aquestive’s
existing 13.5% Senior Secured Notes; Royalties will be payable on Anaphylm annual net sales at the rate of 7.5% initially and scaling down to 1.0%, based on achievement of certain net sales thresholds; The royalty rate could increase to
9.5% if net sales of Anaphylm do not achieve specified levels in prior calendar year periods starting in 2027; Royalty payments will cease upon the Purchaser’s receipt of $187.5M by December 31, 2035 or $225M thereafter (the “Maximum Buy-out
Amount”); The RIPSA includes a buy-out option which provides Aquestive the right to settle all outstanding liabilities at any time by paying a specified buy-out amount, up to the Maximum Buy-out Amount, under various terms and conditions; The
proceeds of the funding will be used for the commercialization of Anaphylm, general corporate purposes and transaction expenses incurred in connection with the RIPSA and related documentation; and The RIPSA contains customary affirmative and
negative covenants, including covenants that limit or restrict Aquestive’s ability to, among other things, incur indebtedness, grant liens, and enter into out-licenses of Anaphylm, in each case subject to certain exceptions. RTW has also
indicated an interest to make a $25M equity investment in Aquestive. Potential Revenue Interest Purchase and Sales Agreement Strictly Confidential. Do Not Distribute.
Lead Asset Anaphylm™ (epinephrine) Sublingual Film Strictly Confidential. Do
Not Distribute.
A Novel Approach to Epinephrine Delivery First and only non-device based, orally
delivered epinephrine product candidate Needle-Free Easy to Administer Delay-Free Designed to Work Quickly1 Device-Free Easy to Carry + + Anaphylm™ (epinephrine) Sublingual Film 1. Aquestive Therapeutics data on file. Strictly
Confidential. Do Not Distribute.
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 AllergenExposure LIKELIHOOD OF OCCURRENCE INITIAL
REACTION 5m 10m 15m 20m 25m 30m 1h 8h 72h 2h 3h 4h 5h 6h 7h 9h 10h TIME During an allergic reaction, time is the enemy 30+ minute delay = Triple risk.1 Up to 73.6% do not receive epinephrine before ER visit2 Benefits of
epinephrine far outweigh the risks2 Strictly Confidential. Do Not Distribute.
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 Significant number of patients diagnosed and under
physician care from 2020 to 20239 Significant number of scripts for epinephrine were filled in 202411 ~100 deaths per year in the U.S. due to anaphylaxis10 MORTALITY RATE: 0.3% of anaphylaxis-related hospitalizations 10 14 Strictly
Confidential. Do Not Distribute.
U.S. Market has the Potential to Grow to ~$2B in Value by 20311 Current Market
Size (2024)²:~$800M Projected Market Size (2031):Over $1B 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 Strictly
Confidential. Do Not Distribute.
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 Strictly Confidential. Do Not Distribute.
Rapid Relief Needed When It Matters Most1 Anaphylm reaches peak absorption in
just 12 minutes Observed to achieve therapeutic blood concentrations in as little as 5 minutes (over 100 pg/ml) Observed to deliver 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®. Strictly Confidential. Do Not Distribute.
Film Dosing Option Preference – Patients and HCPs1 80% prefer a non-injection
dosing method 95% are interested in a film-dosing option PATIENTS AND CAREGIVERS 95% believe a film-dosing option fills an unmet need in the epinephrine market 85% indicated they would Rx a film-dosing option HEALTHCARE PROVIDERS 1.
Aquestive Therapeutics, Inc. data on file. Strictly Confidential. Do Not Distribute.
Anaphylm Anticipated Key Milestones Pediatric Study Completed Q1 2025 NDA
Submission Completed NDA Accepted by the FDA Potential Advisory Committee Meeting Q2 2025 Q3 2025 Q4 2025 Q1 2026 PDUFA action date is scheduled for January 31, 2026 Strictly Confidential. Do Not Distribute.
2024 2025 2026 Anaphylm completed and planned 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 Known epinephrine prescribers/specialties Work with payers to raise awareness Engagement with advocacy groups Congress
attendance Publications 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 Strictly Confidential. Do Not Distribute.
Pipeline Products Strictly Confidential. Do Not Distribute.
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. z HUMAN SKIN STRUCTURE 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 Strictly Confidential. Do Not Distribute.
Alopecia Areata Represents a Potentially Significant Opportunity¹ REASONS TO
BELIEVE Patient unmet need is well-documented and understood Planned development endpoints that are potentially achievable Competitive landscape indicates pricing should continue to be reasonable Commercial opportunity can fit within a
growing Aquestive commercial infrastructure INITIAL TARGET PRODUCT PROFILE² 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. Strictly Confidential. Do Not Distribute.
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 24 Strictly Confidential. Do Not Distribute.
Planned AQST-108 Clinical and Regulatory Approval Timeline Q4 2025 Q1 2026 Q2
2026 Q3 2026 Expect to Open IND Expected Initiation of Phase 2a Strictly Confidential. Do Not Distribute.
Thank You Strictly Confidential. Do Not Distribute.