Exhibit 99.1
Anaphylaxis and EpinephrineR&D Day March 25, 2021
Forward Looking Statement This presentation includes forward-looking statements within the meaning of
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Such risks and uncertainties include, but are not limited to, risks associated with the Company's development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and
plans for AQST-108, AQST-109 and our other drug candidates; risk of delays in FDA approval of our drug candidates, Libervant and AQST-108, AQST-109, and our other drug candidates or failure to receive approval; ability to address the concerns
identified in the FDA’s Complete Response Letter dated September 25, 2020 regarding the New Drug Application for Libervant; risk of our ability to demonstrate to the FDA “clinical superiority” within the meaning of the FDA regulations of
Libervant relative to FDA-approved diazepam rectal gel and nasal spray products including by establishing a major contribution to patient care within the meaning of FDA regulations relative to the approved products as well as risks related to
other potential pathways or positions which are or may in the future be advanced to the FDA to overcome the seven year orphan drug exclusivity granted by the FDA for the approved nasal spray product of a competitor in the U.S. and there can be
no assurance that we will be successful; risk that a competitor obtains FDA orphan drug exclusivity for a product with the same active moiety as any of our other drug products for which we are seeking FDA approval and that such earlier approved
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and long-term liquidity and cash requirements, cash funding and cash burn; risk related to government claims against Indivior for which we license, manufacture and sell Suboxone® and which accounts for the substantial part of our current
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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.PharmFilm® and the Aquestive logo are
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jurisdiction.
Today’s Agenda Topic Presenter(s) Introductions Keith Kendall, CEODan Barber, COO Medical Overview
of Anaphylaxis and Epinephrine David M. Fleischer, MD, FAAAAIProfessor of Pediatrics, Section Head, Allergy and Immunology, Children’s Hospital ColoradoUniversity of Colorado Denver School of Medicine Anaphylaxis Market Overview Michael
Arcara, MBA Commercial Lead, Allergy R&D Overview of AQST-108 and AQST-109 Steve Wargacki, PhDVP of R&D, Aquestive Therapeutics Clinical Lessons from Today’s Products John Oppenheimer, MD Clinical Professor of Medicine at UMDNJ
Rutgers, Pulmonary and Allergy Associates NJ Clinical Overview of AQST-108 and AQST-109 Mark Lepore, MD Chief Medical Officer, Allergy, Aquestive Therapeutics Q&A Closing Remarks Keith Kendall, CEO ®
PharmFilm® Technology – Where You Need It, When You Need It™ And Needle Free
David M. Fleischer, MD, FAAAAIProfessor of PediatricsSection Head, Allergy and ImmunologyChildren’s
Hospital ColoradoUniversity of Colorado Denver School of Medicine Anaphylaxis and EpinephrineMedical Overview
Introduction David M. Fleischer, MD, FAAAAIProfessor of PediatricsSection Head, Allergy and
ImmunologyChildren’s Hospital ColoradoUniversity of Colorado Denver School of Medicine
Defining Anaphylaxis Simons FE. J Allergy Clin Immunol. 2009;124(4):625-636. Patients
at risk for anaphylaxis should have a long-term allergy-management plan Poses serious consequences for at-risk patients Often occurs in the community setting Anaphylaxis is a severe systemic allergic reaction that is rapid in onset and can
cause death
Common Triggers of Anaphylaxis Idiopathic anaphylaxis Exercise Insect venom, medications, and
latex
Common Signs and Symptoms of Anaphylaxis *Potentially life-threatening symptoms. Simons FE. J
Allergy Clin Immunol. 2009;124(4):625-636. Central nervous system10%-15% of episodesUneasiness, throbbing headache, dizziness, confusion, tunnel vision Airway*70% of episodesLarynx: pruritus and tightness in throat; dysphonia and
hoarsenessLung: dyspnea, chest tightness, wheezing/bronchospasm Skin 80%-90% of episodesUrticaria, pruritus, flushingMucosal tissue: pruritus and swelling of lips, tongue, uvula/palate Cardiovascular system*10%-45% of episodesChest pain,
hypotension, tachycardia, weak pulse, dizziness, fainting Gastrointestinal tract30%-45% of episodesNausea, cramping, abdominalpain, vomiting, diarrhea
Patterns of Anaphylaxis UniphasicSigns and symptoms within minutes of exposure to an offending
stimulusBiphasicBiphasic anaphylaxis has an immediate phase with a period of improvement and response to initial therapy, but with recurrent symptoms 2 to 6 hours after the onset of the initial reactionProtractedProtracted anaphylaxis causes
prolonged manifestations (usually respiratory distress or hypotensive shock) for 5 to 32 hours Golden D. Novartis Found Symp. 2004;257:101-110. Anaphylaxissigns and symptoms (minutes to hours) Signs and symptomsoccur 2 to 6 hours
after initial reaction Allergenexposure Likelihood of Occurrence Initial reaction Biphasic reaction 5 m 10 m 15 m 20 m 25 m 30 m 1 h 8 h 72h 2 h 3 h 4 h 5 h 6 h 7 h 9 h 10 h
Epinephrine is first-line treatment for anaphylaxis1Fatality due to anaphylaxis is associated with
delayed epinephrine administration2Failure to administer epinephrine in a timely manner (eg, pre-ED) has been associated with fatalities3Failure to administer epinephrine promptly is the most important factor contributing to death ED,
emergency department.1. Waserman S et al. J Allergy Clin Immunol Pract. 2017;5:1180-1191; 2. Song TT, Lieberman P. Curr Opin Allergy Clin Immunol. 2015;15(4):323-328; 3. Simons FE et al. J Allergy Clin Immunol.
1998;101:33-37. Epinephrine Allergy suspected in mother’s death
Use and Carry Practices for Epinephrine Auto-Injectors Correct use of epinephrine auto-injectors (EAIs)
is surprisingly lowData indicate just 16% to 32%1Studies have shown that:Just half of at-risk patients regularly carry an unexpired EAI2Many patients did not have epinephrine available at the time of a reaction3A majority of caregivers did not
give their allergic children epinephrine at the time of their most severe allergic reactions4 1. 1. Bonds RS et al. Misuse of medical devices. Ann Allergy Asthma Immunol. 2015;114(1):74e76.e2; 2. Arkwright PD, Farragher AJ. Pediatr Allergy
Immunol. 2006;17(3):227e229; 3. Polloni L et al. Pediatr Allergy Immunol. 2020;31(4):380e387; 4. Egan M et al. J Allergy Clin Immunol Pract. 2019;7(2):655e658; 5. Warren CM et al. Ann Allergy Asthma Immunol. 2018;121(4):479e489.e2.. Images:
EpiPen Package Insert, Patient Directions for Use Most common reasons for pitfalls in the use of EAIs are:Lack of auto-injector availabilityInadequate education on how to administer the epinephrineConcern for systemic effects, failure to
administer correctly, and accidental administration5
Adverse Events Due to Incorrect Use of EAIs Publications have raised concerns over laceration and
embedded-needle injuries resulting from the use of EAIs1From 1994 to 2007, >15,000 unintentional injections from EAIs were reported to US Poison Control CentersThose unintentionally injected had a median age of 14 years2Even if EAIs are
available, safety concerns and/or fear of needles may prevent them from being administered in a timely manner1 1. Posner L, Camargo CA Jr. Drug Healthc Patient Saf. 2017;9:9-18; 2. Simons FER et al. J Allergy Clin Immunol.
2010;125(2):419-423.e4. 3. Image: Brown J et al. Lacerations and Embedded Needles Caused by EEAI Use in Children. Annals of Emergency Medicine, 2015.
EAI Refill Rates Are Suboptimal Lack of annual EAI refills can leave at-risk patients without immediate
access to epinephrine when they need itIn 1 large HMO over a 5-year period:A total of just 46% of patients refilled their EAI at least once Just 25% refilled multiple timesOnly 11% refilled each year Kaplan. Curr Allergy Asthma Rep.
2011;11:65-70.
Summary Anaphylaxis is an unpredictable, severe systemic allergic reaction that is rapid in onset and
potentially fatalAt-risk patients should always have immediate access to 2 doses of epinephrineFatality due to anaphylaxis is associated with delayed epinephrine administrationFar too few at-risk patients:Carry their EAI with themRefill their
EAI on an ongoing basisAre confident, timely, and accurate in their use of an EAI during an emergency situationEpinephrine products that are easier for patients to carry and administer would be an important addition to an allergist’s treatment
armamentarium
Michael Arcara Anaphylaxis and EpinephrineMarket Overview
Introduction Michael ArcaraCommercial Lead, AllergyMBA, University of Michigan25 years experience in
pharmaceutical commercial developmentEpinephrine-specific experience: Mylan (EpiPen); Valeant (Emerade)
Epidemiology: Life-Threatening Allergic Reaction1,2 Anaphylaxis epidemiology is not well definedStudies
estimate that 1.6% to 5.1% of the US population has actually had an anaphylaxis episodeOne set of data indicates that people dying from food allergy often had previous reactions but these were typically not severe3Per CDC: the prevalence of
food allergies in children increased by 50% between 1997 and 2011 1. Woods et al. J Allergy Clin Immunol. 2014;133:461-467; 2. Food Allergy Research & Education website. https://www.foodallergy.org/resources/facts-and-statistics; 3.
Pumphrey R. Anaphylaxis: can we tell who is at risk of a fatal reaction? Curr Opin Allergy Immunol. 2004.
Overview: Epinephrine Market Prescription market was still growing and peaked just before Teva generic
entered2018-current = significantly diminished HCP/consumer promotionLarge percentage of EAI prescriptions—especially first-time prescriptions—are driven by allergists and pediatriciansTarget HCP universe ~20,000 physiciansCurrent EpiPen ®
2-Pak WAC: ~$300 Epinephrine: US market 2014 2015 2016 2017 2018 2019 2020 Market prescriptions, millions 3.6 3.8 3.8 3.6 3.1 3.2 3.0 Market $, billions 1.4 1.9 2.4 2.1 1.8 1.9 1.5 Source: Symphony Health PHAST
(Pharmaceutical Audit Suite)
Physician Research: Providers Indicate Preference for Alternative Route of Administration 89% at least
somewhat prefer *Aquestive sponsored online survey; N=500 allergists, pediatricians, and PCPs; fielded 2018. Data on file. To what extent would you prefer an alternative administration route for epinephrine?
How concerned are you with patients and/or their caregivers consistently having their auto-injector(s)
with them when they leave home? Physician Research: Concerns About Patients Having EAI With Them at All Times 88% at least somewhat concerned *Aquestive sponsored online survey; N=500 allergists, pediatricians, and PCPs; fielded 2018. Data
on file.
Patient Survey: Unprompted Unmet Need Top 3 Box: 74% Top 4 Box: 88% *Aquestive sponsored online,
5-minute survey; N=75 EAI patients, 75 caregivers; fielded February 2021. Data on file To what extent would you prefer a new way to dose epinephrine?
Interest in the film medicine being available to replace your EAI Patient Survey: First Exposure to
Film Dosing At Least Some Interest: 99% *Aquestive sponsored online, 5-minute survey; N=75 EAI patients, 75 caregivers; fielded February 2021. Data on file
Patient Survey: Impact, Epinephrine On Hand I believe the smaller package would make it more likely for
me to have the film with me when I need it (vs EAI): *Aquestive sponsored online, 5-minute survey; N=75 EAI patients, 75 caregivers; fielded February 2021. Data on file
Patient Survey: Ask Doctor About Film Top 3 Box: 90% Top 4 Box: 96% How likely would you be to ask
your doctor about the film? *Aquestive sponsored online, 5-minute survey; N=75 EAI patients, 75 caregivers; fielded February 2021. Data on file
PharmFilm delivers market share within existing market Aquestive allergy franchise delivers
market expansion Our View of the Epinephrine Commercial Opportunity Features/benefits customers are looking for in a new epinephrine delivery:PortabilityUsabilityNeedle freeTemperature tolerability*Waterproof/resistant* Expected
opportunities to increase the customer base:Previously reluctant (e.g., needle-phobic or size-resistant) patients more readily adopt PharmFilm dosingIncreased carry rates due to size, in turn, increase engagement with the brand and annual
refill ratesGiven current lack of promotion in the market, Aquestive launch plans to re-engage HCPs, patients, and advocacy groups Patient convenience Medical advance + *Target Product Profile
Aquestive PharmFilm – Potential Annual Peak Net Sales* No market expansionPharmFilm share
<30% $500M $250M Modest market expansionPharmFilm share = 30% - 50% Significant market expansionPharmFilm share >50% *Potential sales revenues are based on current sales information from Symphony Health PHAST (Pharmaceutical Audit
Suite) (See Slide 19) assuming peak sales at ~5 years post launch.
Summary: Anaphylaxis and Epinephrine A large and growing patient population at risk for anaphylaxis
existsPharmFilm, as a dosage form, has the potential to deliver on physician- and patient-articulated unmet needs in the marketplace: smaller size and needle freeAquestive’s PharmFilm technology represents an exciting and significant pipeline
opportunity
Stephen Wargacki, Ph.D.Vice President R&D Anaphylaxis and EpinephrineAquestive Epinephrine Program
Introduction Stephen Wargacki, PhDVice President, R&DJoined Aquestive in 2015PhD, Polymer
ChemistryUniversity of TennesseePostdoctoral FellowAir Force Research Laboratory12 years experience in alternative drug delivery24 publications (286 citations)47 patents (18 patent families)
Challenges of Epinephrine for Anaphylaxis EPINEPHRINE ↑ CardiacOutput Dilates
Coronary Vessels ↑ Muscle Contraction Efficiency ↑ Fatty AcidRelease ↑ Mental Alertness ↑ ACTH & TSH Release ↑ Glycogen→Glucose ↓ Intestinal Mobility VARIABLE
Noninvasive Delivery of Epinephrine Why has science not overcome the challenges of alternative
epinephrine delivery? Overcome with Traditional Formulation Techniques Prevents rapid, consistent absorption Vasoconstriction Normal blood flow Restricted blood flow Hydrophilic Absorptionand Speed Unstable
PharmFilm® for Delivery of Oral Epinephrine Mean profiles for initial epinephrine film compared with
EpiPen® in Study 160455 EpiPen® 0.3mg (mean/SD) Epinephrine Sublingual Film (mean/SD) Time (minutes) Epinephrine plasma concentration [pg/mL]
Uses of Prodrugs in Pharmaceuticals * Since 2015, prodrugs have accounted for ~10% of all small
molecules that have come to market in the United States. Reference: European Journal of Pharmaceutical Sciences, (109) 2017, pg 146 What are prodrugs*? Drug with suboptimal properties Drug bounded to another molecule for improved
properties Drug released by metabolic processes
AQST-108: L-Dipivefrin Receptors Epinephrine (µM) Dipivefrin(µM) Dipivefrin vs Epi(ratio) α1
receptors 0.00018 0.41 2278 Property Epinephrine Dipivefrin Log P -0.43 3.71
Impact of AQST-108 on Sublingual Delivery of Epinephrine Increased absorption at similar dosesComparable
Cmax, AUC to injectable from previous study AQST-108 (N=6) Average Epinephrine Plasma Profile From Prototypes Generations 1 and 2 EpiPen® (N=9) Epinephrine Film No Prodrug (N=9)
Epinephrine Prodrug (AQST-108) Overcomes Vasoconstriction 18 min Tmax Aquestive’s library of
epinephrine prodrugs can control conversion ratePotential to: Improve Tmax epinephrineReduce dosageIncrease Cmax AQST-108 (Dipivefrin) sublingual filmStrong, consistent absorptionRapid TmaxRequires faster conversion for improved epinephrine
PK
Introducing AQST-109: 2nd Generation Epinephrine Prodrug Attribute Relative to AQST-108 Permeation
Rate Increased Conversion Rate Increased Required Dose Decreased Tolerability Increased MiniPig data show similar exposure at lower doses Prototypes Epinephrine Cmax (ng/mL) N=5 AQST-108 (24mg) 2.7 AQST-109 (6mg) 3.0 Half
Life AQST-108 AQST-109 Minipig 3.1 0.8 Dog 16.0 NC* Human 10.3 NC* In vitro data showing instant conversion of AQST-109 *Too fast to calculate
Patent Applications Extending into 2041 Innovation Patent Status Permeation enhancers that improve
delivery of epinephrine, PK and PD 1 US application8 Foreign applicationsPriority date: May 5, 2016Possible patent term to 2037 Permeation enhancers that improve delivery of dipivefrin and epinephrine, PK and PD 2 US applications8 Foreign
applicationsPriority date: May 4, 2017Possible patent term to 2037 Prodrugs of epinephrine and permeation enhancers, conversion rates, PK and PD 2 US applications1 Foreign applicationPriority date: late 2019Possible patent term to 2041
John Oppenheimer, MD Anaphylaxis and EpinephrineClinical Lessons From Today’s Injectable Products
Introduction John Oppenheimer, M.D.UMDNJ Rutgers University School of MedicinePulmonary & Allergy
Associates
Indirect and observational evidence of effectiveness1There are no randomized, placebo-controlled efficacy
and safety studies in patientsCochrane Collaboration confirmed this finding2 PK and PD comparability is importantThere is no ethical clinical model for anaphylaxis Epinephrine Is Effective PK, pharmacokinetic; PD, pharmacodynamic.1.
Lieberman P et al. Ann Allergy Asthma Immunol. 2015;115:341-384; 2. AAAAI online website. March 29, 2018. Accessed March 9, 2021. https://www.aaaai.org/global/latest-research-summaries/New-Research-from-JACI-In-Practice/epinephrine
Optimal Dose is Unknown1 No data to support the “correct dose”1 In adults, a higher dose was previously
well accepted1 Dose-ranging and optimal dose selection for the FDA-approved EAI products2 EAI, epinephrine auto-injector; FDA, US Food and Drug Administration.1. Lieberman P et al. Ann Allergy Asthma Immunol. 2015;115:341-384; 2. EpiPen.
Prescribing information. Mylan Specialty LP; 2020;
Injected EpinephrinePK and PD Considerations PK and PD data from epinephrine administered via injection
are sparsePublished studies suggest a wide variation in Cmax and Tmax1 IM, intramuscular.1. Dworaczyk D, Hunt A. Presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) National Conference, March 16, 2020.
https://brynpharma.com/media/content/docs/comparative-delivery-poster.pdf; 2. Dworaczyk D, Hunt J Allergy Clin Immunol Pract. 2021;147(2):(2 suppl)AB241 Presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) National
Conference; March 16, 2020; Accessed March 2, 2021. 3. Worm M et al. Clin Transl Allergy. 2020;10:21; 4. Duvauchelle T et al. J Allergy Clin Immunol Pract. 2018;6(4):1257-1263; 5. Breuer C et al. Eur J Clin Pharmacol. 2013;69:1303-1310; 6. US
FDA Epinephrine (Auvi-Q) clinical pharmacology and Biopharmaceutics review. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201739Orig1s000ClinPharmR.pdf. Accessed on February 25, 2021; 7. Edwards ES et al. Ann Allergy Asthma Immunol.
2013;111(2):132-137. Author, year Device Mean Cmax (pg/mL) Mean Tmax(min) Dworaczyk and Hunt, 20201 EpiPen 0.3 mg 308 16 Dworaczyk and Hunt, 20212 EpiPen 0.3 mg 288 10 Worm M et al, 20203 EpiPen 0.3 mg 520b,d 9c IM injection
0.3 mg 310a,b 40c Duvauchelle T et al, 20184 Anapen 0.3 mg 377 12d Breuer C et al, 20135 Anapen 0.3 mg 484b 13d Auvi-Q FDA Review6Edwards et al 20137 Auvi-Q 0.3 mg 486 20d EpiPen 0.3 mg 520 10d aNanogram to
picogram converted; buncorrected values; cmedian value; dconverted to minutes from hours.
Variability of Epinephrine Injected Into Muscle Data on file from Study 200203 top line results. Mean
(±SD) baseline corrected epinephrine concentration over scheduled timeby treatment, linear scale 6005004003002001000 Concentration (pg/mL) 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 (0.3-mg IM injection) Time (h)
Increase in systolic blood pressure Increase in diastolic blood pressure Increase in heart rate Known
Pharmacodynamic (PD) Markers for Epinephrine Simons FE. J Allergy Clin Immunol. 2009;124(4):625-636.
Key PK Measures Based on Approved Products1-7 Cmax range280 pg/mL–530 pg/mLMedian Tmax range<20
min 1. Dworaczyk D, Hunt A. Presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) National Conference, March 16, 2020. https://brynpharma.com/media/content/docs/comparative-delivery-poster.pdf; 2. Dworaczyk D, Hunt J
Allergy Clin Immunol Pract. 2021;147(2):(2 suppl)AB241 Presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) National Conference; March 16, 2020; Accessed March 2, 2021. 3. Worm M et al. Clin Transl Allergy. 2020;10:21; 4.
Duvauchelle T et al. J Allergy Clin Immunol Pract. 2018;6(4):1257-1263; 5. Breuer C et al. Eur J Clin Pharmacol. 2013;69:1303-1310; 6. US FDA Epinephrine (Auvi-Q) clinical pharmacology and Biopharmaceutics review.
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201739Orig1s000ClinPharmR.pdf. Accessed on February 25, 2021; 7. Edwards ES et al. Ann Allergy Asthma Immunol. 2013;111(2):132-137.
Dose levels for epinephrine have been established through decades of clinical experience rather than
via efficacy studiesStudies have shown a wide variation in PK results after injecting epinephrinePD markers for epinephrine are well establishedFor injected epinephrine products, an expected range for Cmax and Tmax can be established from the
literature Summary
Dr. Mark LeporeChief Medical OfficerAllergy Therapies Anaphylaxis and EpinephrineAQST-108 and AQST-109:
Clinical Overview
A Brief Introduction Dr. Mark LeporeChief Medical Officer, Allergy TherapiesTrained in general
pediatrics and allergy/clinical immunologyFellow of AAAAI 10 years experience in private practice as a clinical investigator Teva Global Respiratory R&D and US Medical AffairsLupin R&D, Inhalation and Complex Injectable ProductsFather
of 3 food-allergic children
Aquestive’s Approach for Sublingual Film Delivery Absorption(via prodrugs)Conversion(into
epinephrine) +
AQST-108: Clinical Trials Review Protocol 2002037-period, 4-treatment (with replication of 3
treatments), 3-sequence crossoverTest–24 mg dipivefrin sublingual filmRef 1–0.3 mg SC epinephrineRef 2–0.3 mg IM epinephrineSafety–0.5 mg SC epinephrine (not replicated, period 7)28 subjects enrolledPK and PD measurementsFrequent sampling from
pre-dose to 240 minutes post-dose Protocol 180299Single-ascending dose study in healthy young male volunteers*Part 1–dose levels of 0.6 mg, 3 mg, 6 mg, 12 mg, 24 mg, 30 mg, and 36 mg6-12 subjects per dose levelPK and PD measurementsFrequent
sampling from pre-dose to 240 minutes post-dose *Also referred to as a proof of concept or dose-escalation study.
AQST-108: Rapid and Extensive Absorption* Description -203 -299 Cmax (pg/mL) 1276 1487 AUC 0-t
(hr*pg/mL) 425 480 Tmax (min) 18 20 Tmax range (min) 10-40 15-34 * Compared with IM or SQ injected epinephrine **Represents 203 data from top line results. Time (hr) Dipivefrin Concentration (pg/mL) 20 min 18 min P200203,
Test ** P180299, Test
AQST-108: Conversion into Epinephrine Systemically * Represents data from top-line
results. Description -203 -299 Cmax (pg/ml) 205 261 AUC 0-t (hr*pg/ml) 332 497 Tmax (min) 40 28 Tmax Range (min) 11 - 106 20 - 60 Time (hr) Concentration (pg/mL) P200203, Test P180299, Test
AQST-108: Compelling Pharmacodynamic (PD) Results When Compared to Epinephrine IM Injection *Represents
data from top-line results.SBP=Systolic Blood Pressure AQST-108 AQST-108 0.3mg IM IM Concentration (pg/mL) Concentration (pg/mL) Time (hr) Epinephrine Mean ConcDipivefrin Mean ConcSBP Time (hr) Epi ConcentrationSBP AUCT
SBP (hour* mmHg) Treatment
AQST-108: Critical Insights from Conversion Rate *Represents data from top-line
results. Description AQST-108 SQ Injection IM Injection Cmax (pg/mL) 205 388 475 AUC 0-t (hr*pg/mL) 332 551 483 Tmax (min) 40 31 30 Tmax Range (min) 11-106 8-68 4-75 Time (hr) Concentration (pg/mL) P200203, TestP200203,
Ref 1P200203, Ref 2P180299, 24 mg
Epi SF AQST-108Dipivefrin AQST-109 Epinephrine/Prodrug Development
Progression Study160445 Studies180299200203
Part 25-period crossoverN=12Repeat of 1 formulation at target dose from part 11-2 optimized
formulations1 dosing administration change1 RLD (0.3 mg IM injection) AQST-109 Designed to Minimize Conversion Time Cohort 10.6 mg/mL SL drops Part 1Single-ascending dose (SAD)N=6 per cohort Cohort 21.2 mg/mL SL drops Cohort 33 mg SL
film (formulation 1) Cohort 4-7 (1 per formulation)4 formulations of SL filmDose escalation 6 mg, 12 mg, 18 mg, 24 mg 1 2 3 4 Established targetdose from Part 1
Summary Aquestive’s AQST-108 has demonstratedRapid and extensive absorptionConversion to epinephrine,
but slower than desiredCompelling changes in PD measuresNext steps Advance AQST-109 into PK trialsMeet with FDA to discuss AQST-108 PD results and next steps
Anaphylaxis and EpinephrineR&D Day: Summary March 25, 2021
Clinical/Regulatory Timeline – 2 “shots on goal” Single dose ascending study completed in H2 2019FDA
pre-IND meeting completed in H1 2020FDA fast track designation received in H1 2020Phase 1 crossover study completed in H2 2020Anticipate FDA meeting in H2 2021 AQST-108 sublingual film First in Humans (FIH) Study dossier submitted to Health
Canada; following study, anticipate:FIH Study read-out in H2 2021FDA pre-IND meeting in H2 2021Opening IND in early 2022 AQST-109 sublingual film The Clinical Trial Application (CTA) is under review. Should Health Canada (HC) request
additional information, the study timelines may be impacted. There can be no assurance that HC will take action on the CTA in a timely fashion. Anticipate:Conducting pilot and pivotal PK studies in 2022Conducting human factors study in
2022Pre-NDA meeting with FDA end 2022
Key Takeaways Large unmet need and a growing patient population AQST-108 and AQST-109 represent
compelling opportunities for the oral delivery of epinephrineThere is a known FDA pathway to approval
