{"success":true,"data":{"pressRelease":{"id":"33994","rtpr_id":"nGNXcbYQPp","ticker":"AQST","exchange":"NASDAQ","all_tickers":["AQST"],"title":"Aquestive Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update","author":"Globe Newswire","published_at":"2026-05-13T20:01:01.344Z","article_body":"* Reaffirms guidance to resubmit Anaphylm™ (dibutepinephrine) sublingual\nfilm NDA in Q3 2026\n* Affirms existing clinical data is sufficient for submitting regulatory\napplications in Canada, European Union, and the United Kingdom\n* Completed AQST-108 phase 1 study in subjects with androgenic alopecia with\nno safety issues observed\n* Entered into a $150 million debt facility with Oaktree Capital Management,\nL.P.\n* Company to host investor call on May 14, 2026, at 8:00am ET\nWARREN, N.J., May 13, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc.\n(NASDAQ: AQST) (\"Aquestive\" or the \"Company\"), a pharmaceutical company\nadvancing medicines to bring meaningful improvement to patients' lives through\ninnovative science and delivery technologies, today announced financial\nresults for the first quarter ended March 31, 2026, and provided a strategic\nbusiness update.\n\n“We made rapid and meaningful progress in the first quarter,” said Daniel\nBarber, President and Chief Executive Officer of Aquestive. “We successfully\ncompleted our Type A meeting with the FDA, aligning on the study designs\nneeded to support resubmission of the Anaphylm NDA, which we continue to\ntarget for the third quarter of 2026. In parallel, our commercial readiness\nefforts continue. We are making the most of this time by driving awareness of\nAnaphylm among healthcare professionals. We are building momentum for our\nAdrenaVerse™ platform and are excited by the recent results from our\nAQST-108 phase 1 study. Financially, we have taken steps to further strengthen\nour balance sheet and extend our cash runway, and we believe we are\nwell-positioned to execute on our key objectives in 2026 and beyond.”\n\nAnaphylm™ (dibutepinephrine) sublingual film\nAnaphylm is a no-needle, no-device epinephrine product candidate being\ndeveloped for the treatment of Type I allergic reactions, including\nanaphylaxis. The Company believes Anaphylm has the potential to be the first\nand only non-invasive, orally delivered epinephrine product, if approved by\nthe U.S. Food and Drug Administration (FDA).\n\nIn the first quarter of 2026, Aquestive successfully completed its Type A\nmeeting with the FDA, aligning on the study designs for both the human factors\nvalidation and pharmacokinetics (PK) studies required to address the\ndeficiencies identified in the Complete Response Letter (CRL) from the FDA\ndated January 30, 2026. The Company reaffirms its guidance to resubmit the\nAnaphylm New Drug Application (NDA) in the third quarter of 2026, subject to\ncompletion of the required studies and expected FDA response timelines. As\npreviously disclosed, the CRL did not identify any chemistry, manufacturing,\nor controls (CMC) deficiencies, and clinical results supporting comparability\nto auto-injectors were not questioned. The Company will request an accelerated\nreview upon resubmission, though no expedited review can be guaranteed.\n\nIn February 2026, Aquestive presented data at the American Academy of Allergy,\nAsthma & Immunology (AAAAI) Annual Meeting. Data presented demonstrated that\nAnaphylm achieved clinically relevant epinephrine plasma concentrations\nwithout the diastolic blood pressure dip associated with auto-injector\nadministration, providing further clinical differentiation. Feedback from key\nopinion leaders (KOLs) and the broader allergy community continues to be\npositive, and physician enthusiasm for a non-invasive, non-device epinephrine\ntreatment option remains strong.\n\nAquestive continues to advance its global regulatory strategy for Anaphylm.\nThe Company remains on track to submit regulatory applications in Canada, the\nEuropean Union and United Kingdom by utilizing its existing clinical data. The\nCompany recently completed a meeting with the Medicines and Healthcare\nproducts Agency, which is the health regulatory agency for the United Kingdom.\nIn addition, the Company submitted its initial Pediatric Investigation Plan\n(PIP) to the European Medicines Agency (EMA), an important step in preparing\nfor full submission of the Company's Market Authorization Application for the\nEuropean Union.\n\nAquestive has advanced its commercial infrastructure in preparation for a\npotential Anaphylm approval. The Company has expanded its planned field force\nto approximately 75 sales representatives - a 50% increase from its prior\nguidance of 50 representatives - better positioning the Company to reach\npatients and healthcare providers across the country. Current priorities\ninclude continued engagement with healthcare professionals through our\nrecently expanded Medical Affairs team to increase Anaphylm awareness, market\naccess preparation ahead of a potential approval, and active collaboration\nwith leading patient advocacy organizations in the allergy community.\n\nAQST-108 (epinephrine) topical gel\nAQST-108 is a topical epinephrine prodrug gel product candidate being\nevaluated for potential dermatologic indications. Aquestive made meaningful\nclinical development progress with AQST-108 in the first quarter of 2026. The\nCompany recently completed its second phase 1 clinical trial, which was\ndesigned to further characterize the safety, tolerability, and pharmacologic\nprofile of the topical epinephrine prodrug gel. There were no drug related\nadverse events observed in the study and the data did not indicate signs of\nsystemic absorption. In addition, Aquestive identified a biomarker signal\nthrough the suppression of the cytokine thymic stromal lymphopoietin (TSLP)\nwhen compared to placebo. The TSLP signaling pathway involves the activation\nof Janus Kinase (JAK) 1 and JAK2. This signal will be explored further in\nupcoming studies.\n\nBuilding on the IND opening and supportive FDA feedback received in December\n2025, Aquestive continues to believe AQST-108 has potential application across\na variety of dermatological conditions, including alopecia areata, atopic\ndermatitis, rosacea, and psoriasis. Aquestive plans to further study AQST-108\nby utilizing an atopic dermatitis study design in the upcoming months. This\ndisciplined, data-driven approach is consistent with the Company’s strategy\nof maximizing the value of the AdrenaVerse™ platform while maintaining focus\non the Anaphylm NDA resubmission.\n\nAlopecia areata remains a significant unmet need, affecting an estimated 6.7\nmillion people in the United States, with 43% classified as severe. JAK\ninhibitors, the current standard of care, are systemic agents carrying black\nbox warnings in a market currently valued at over $1 billion. AQST-108’s\ntopical, localized delivery profile may provide a differentiated option for\nthese patients, if clinical development is successful.\n\nAtopic dermatitis affects approximately 7%–10% of U.S. adults and 10–20%\nof children, making it one of the most common chronic inflammatory skin\ndiseases in the U.S.\n\nAquestive’s AdrenaVerse platform comprises approximately 20 epinephrine\nprodrugs designed to enable control of absorption and conversion rates across\na range of dosage forms and delivery sites. The Company remains excited by the\nAdrenaVerse platform’s long-term potential to address multiple indications.\n\nDebt Refinancing\nAquestive entered into a new $150 million debt facility with Oaktree Capital\nManagement, L.P., a leading life sciences debt provider. Refinancing the\nCompany's existing debt will save the Company $45 million in principal\npayments over the next three years. Further, this new debt facility provides\nthe Company with improved interest rate terms and principal payments that will\nnot begin until maturity in 2031. In addition to the $55.0 million provided at\nsigning, Aquestive will have the ability to access $20 million of capital in\nthe event of FDA approval of Anaphylm. A third tranche of $25.0 million will\nbe available upon the achievement of specified sales milestones, with the\nfinal tranche of up to $50.0 million available with the mutual consent of the\nlenders and the Company. This refinancing allows the Company to achieve one of\nthe pre-approval requirements for Aquestive's $75 million strategic funding\nagreement with funds managed by RTW Investments, LP. With the new debt\nfacility and the strategic RTW funding agreement, the Company expects to have\n$150 million in cash and cash equivalents for the launch of Anaphylm, if\napproved by the FDA in 2027.\n\nCommercial Collaborations and Other \nAquestive continues to manufacture products for the licensing and supply\ncollaborations that it has established. The Company manufactured approximately\n33 million doses in the first quarter 2026, compared to approximately\n27 million doses in the first quarter 2025. The Company continues to\nmanufacture Indivior’s Suboxone(® )Sublingual Film product and the\nCompany's other global collaborations, including Sympazan(® )(clobazam) oral\nfilm product for Cosette Pharmaceuticals, Inc. in the U.S., Ondif(®)\n(Ondansetron) oral film product for Hypera Pharma in Brazil and Emylif®\n(riluzole) oral film product by Zambon S.p.A in Europe. Aquestive’s\nmanufacturing business remains steady.\n\nOn April 8, 2026, Cosette Pharmaceuticals, Inc. (\"Cosette\"), a United\nStates-based, branded specialty pharmaceutical company, acquired the rights to\nSympazan for the treatment of seizures associated with Lennox-Gastaut Syndrome\nin patients two years of age and older, from Assertio Holdings, Inc.\n(\"Assertio\"), including Assertio's rights under our License Agreement for\nSympazan with Otter Pharmaceuticals, LLC, a subsidiary of Assertio (the\n\"Assertio License Agreement\"). Cosette will continue to purchase Sympazan(®\n)(clobazam) Oral Film Product and pay royalties and milestones to Aquestive\nunder the Assertio License Agreement.\n\nThe Company, being a U.S. based manufacturer with intellectual property\ndomiciled in the U.S., confirms that its supply chain currently remains\nlargely unaffected by both implemented and proposed government tariffs,\nproviding continued reliability and stability in production and global\ndistribution for the near term.\n\nSales of royalty-based products, inclusive of Sympazan, contributed to the\nCompany's revenue in the first quarter of 2025.\n\nLibervant(®) (diazepam) buccal film remains tentatively approved until\nJanuary 2027, the scheduled date of expiration of U.S. market orphan drug\nexclusivity of an FDA approved product of another company. Aquestive continues\nto believe that expanding patient access to non-invasive seizure rescue\ntherapies is vital and remains committed to putting Libervant in the hands of\npatients when granted full approval for U.S. market access by the FDA.\n\nFirst Quarter 2026 Financials\nTotal revenues increased to $14.4 million in the first quarter 2026 from $8.7\nmillion in the first quarter 2025. The 66% increase was primarily driven by\nincreases in license and royalty revenue and increases in manufacture and\nsupply revenue.\n\nLicense and royalty revenue increased to $5.4 million in the first quarter\n2026 from $0.8 million in the first quarter 2025, primarily due to royalty\nrevenue from Zevra.\n\nManufacture and supply revenue increased to $8.8 million in the first quarter\n2026 from $7.2 million in the first quarter 2025, primarily due to increases\nin Suboxone revenues, partially offset by lower Ondif revenues.\n\nResearch and development expenses decreased to $4.2 million in the first\nquarter 2026 from $5.4 million in the first quarter 2025. The decrease in\nresearch and development expenses was primarily due to lower clinical trial\ncosts associated with the Anaphylm development program, partially offset by\nincreases in R&D personnel costs.\n\nSelling, general and administrative expenses decreased to $11.0 million in the\nfirst quarter of 2026 from $19.1 million in the first quarter of 2025. The\ndecrease primarily represents the one-time Anaphylm PDUFA fee of $4.3 million\nin the prior year period, lower legal fees of approximately $3.4 million,\nlower commercial spending of approximately $2.0 million, and lower regulatory\nand licensing fees of approximately $0.5 million, partially offset by higher\nseverance costs of approximately $0.6 million, higher personnel costs of\napproximately $0.5 million and higher share-based compensation expenses of\napproximately $0.5 million.\n\nAquestive’s net loss for the first quarter 2026 was $8.1 million, or $0.07\nfor both basic and diluted loss per share, compared to the net loss in the\nfirst quarter 2025 of $22.9 million, or $0.24 for both basic and diluted loss\nper share. The decrease in net loss was primarily driven by decreases in\nselling, general and administrative expenses and research and development\nexpenses and increases in revenues, partially offset by decreases in interest\nincome and other income, net.\n\nNon-GAAP adjusted EBITDA loss was $1.7 million in the first quarter 2026,\ncompared to non-GAAP adjusted EBITDA loss of $17.6 million in the first\nquarter 2025.\n\nCash and cash equivalents were $110.7 million as of March 31, 2026.\n\n2026 Outlook\nAquestive's full-year 2026 financial guidance remains unchanged.\n\nThe Company expects:\n\n                                              Guidance    \n Total revenue (in millions)                  $46 to $50  \n Non-GAAP adjusted EBITDA loss (in millions)  $35 to $30  \n                                                          \n\nTomorrow’s Conference Call and Webcast Reminder\nThe Company will host a conference call at 8:00 a.m. ET on Thursday, May 14,\n2026.\n\nIn order to participate, please register in advance here to obtain a local or\ntoll-free phone number and your personal pin.\n\nA live webcast of the call will be available on Aquestive’s website at:\nFirst Quarter 2026 Earnings Call.\n\nAbout Anaphylm™\nAnaphylm™ (dibutepinephrine) sublingual film is a polymer matrix-based\nepinephrine prodrug product. Anaphylm is similar in size to a postage stamp,\nweighs less than an ounce, and begins to dissolve on contact. No water or\nswallowing is required for administration. The primary packaging for Anaphylm\nis thinner and smaller than an average credit card, can be carried in a\npocket, and is designed to withstand weather excursions such as exposure to\nrain and/or sunlight. The Anaphylm trade name for AQST-109 has been\nconditionally approved by the FDA. Final approval of the Anaphylm proprietary\nname is conditioned on FDA approval of the product candidate.\n\nAbout AQST-108\nAQST-108 (epinephrine) topical gel is a topically delivered adrenergic agonist\nprodrug product candidate. Aquestive completed a first-in-human study for\nAQST-108 without any serious or topical adverse events observed. AQST-108 is\nbased on Aquestive’s AdrenaVerse™ platform which contains a library of\nover twenty epinephrine prodrug products intended to control absorption and\nconversion rates across a variety of possible dosage forms and delivery sites.\n\nAbout Libervant®\nLibervant(®) (diazepam) buccal film is a buccally, or inside of the cheek,\nadministered film formulation of diazepam, a benzodiazepine intended for the\nacute treatment of intermittent, stereotypic episodes of frequent seizure\nactivity (i.e., seizure clusters, acute repetitive seizures) that are distinct\nfrom a patient’s usual seizure pattern in patients with epilepsy. Aquestive\ndeveloped Libervant as an alternative to the device-based products currently\navailable for patients with refractory epilepsy, including a rectal gel and\nnasal spray products. The FDA approval for U.S. market access received in\nApril 2024 for Libervant was for these epilepsy patients between two and five\nyears of age. However, the FDA converted this approval to a \"tentative\napproval\" due to a subsequent court ruling finding that the FDA did not have\nauthority to approve Libervant for U.S. market access for patients aged\nbetween two and five years due to the existing orphan drug market exclusivity\ngranted by the FDA to an intranasal spray of another company. The FDA granted\ntentative approval in August 2022 for Libervant for treatment of these\nepilepsy patients twelve years of age and older. U.S. market access for\nLibervant patients is currently subject to the expiration of the existing\norphan drug market exclusivity of the previously FDA approved drug scheduled\nto occur in January 2027.\n\nImportant Safety Information\nDo not give Libervant to your child between the ages of two and five if your\nchild is allergic to diazepam or any of the ingredients in Libervant or has an\neye problem called acute narrow angle glaucoma.\n\nWhat is the most important information I should know about Libervant?\n* Libervant is a benzodiazepine medicine. Taking benzodiazepines with opioid\nmedicines, alcohol, or other central nervous system (CNS) depressants\n(including street drugs) can cause severe drowsiness, breathing problems\n(respiratory depression), coma, and death. Get emergency help right away if\nany of the following happens: * shallow or slowed breathing,\n* breathing stops (which may lead to the heart stopping),\n* excessive sleepiness (sedation).\nDo not allow your child to drive a motor vehicle, operate heavy machinery, or\nride a bicycle until you know how taking Libervant with opioids affects your\nchild.\n* Risk of abuse, misuse, and addiction. Libervant is used in children 2 to 5\nyears of age. The unapproved use of Libervant has a risk for abuse, misuse,\nand addiction, which can lead to overdose and serious side effects including\ncoma and death.\n* Serious side effects including coma and death have happened in people who\nhave abused or misused benzodiazepines, including diazepam (the active\ningredient in Libervant). These serious side effects may also include\ndelirium, paranoia, suicidal thoughts or actions, seizures, and difficulty\nbreathing. Call your child’s healthcare provider or go to the nearest\nhospital emergency room right away if you get any of these serious side\neffects. * Your child can develop an addiction even if your child takes\nLibervant as prescribed by your child’s healthcare provider.\n* Give Libervant exactly as your child’s healthcare provider prescribed.\n* Do not share Libervant with other people.\n* Keep Libervant in a safe place and away from children.\n \n* Physical dependence and withdrawal reactions. Libervant is intended for use\nif needed in order to treat higher than usual seizure activity.\nBenzodiazepines, including Libervant, can cause physical dependence and\nwithdrawal reactions, especially if used daily. Libervant is not intended for\ndaily use. * Do not suddenly stop giving Libervant to your child without\ntalking to your child’s healthcare provider. Stopping Libervant suddenly can\ncause serious and life-threatening side effects, including, unusual movements,\nresponses, or expressions, seizures that will not stop (status epilepticus),\nsudden and severe mental or nervous system changes, depression, seeing or\nhearing things that others do not see or hear, homicidal thoughts, an extreme\nincrease in activity or talking, losing touch with reality, and suicidal\nthoughts or actions. Call your child’s healthcare provider or go to the\nnearest hospital emergency room right away if your child gets any of these\nsymptoms.\n* Some people who suddenly stop benzodiazepines have symptoms that can last\nfor several weeks to more than 12 months including, anxiety, trouble\nremembering, learning, or concentrating, depression, problems sleeping,\nfeeling like insects are crawling under your skin, weakness, shaking, muscle\ntwitching, burning, or prickling feeling in your hands, arms, legs or feet,\nand ringing in your ears.\n* Physical dependence is not the same as drug addiction. Your child’s\nhealthcare provider can tell you more about the differences between physical\ndependence and drug addiction.\n \n* Do not give your child more Libervant than prescribed or give Libervant more\noften than prescribed.\nLibervant can make your child sleepy or dizzy and can slow your child’s\nthinking and motor skills.\n* Do not allow your child to drive a motor vehicle, operate machinery, or ride\na bicycle until you know how Libervant affects your child.\n* Do not give other drugs that may make your child sleepy or dizzy while\ntaking Libervant without first talking to your child’s healthcare provider.\nWhen taken with drugs that cause sleepiness or dizziness, Libervant may make\nyour child’s sleepiness or dizziness much worse.\nLike other antiepileptic medicines, Libervant may cause suicidal thoughts or\nactions in a small number of people, about 1 in 500.\n* Call a healthcare provider right away if your child has any of these\nsymptoms, especially if they are new, worse, or worry you: * thoughts about\nsuicide or dying\n* new or worse depression\n* feeling agitated or restless\n* trouble sleeping (insomnia)\n* acting aggressive, being angry or violent\n* other unusual changes in behavior or mood\n* attempts to commit suicide\n* new or worse anxiety or irritability        \n* an extreme increase in activity and talking (mania)\n* new or worse panic attacks\n* acting on dangerous impulses\n \n* Pay attention to any changes, especially sudden changes in mood, behaviors,\nthoughts, or feelings.\n* Keep all follow-up visits with your child’s healthcare provider as\nscheduled.\n* Call your child’s healthcare provider between visits as needed, especially\nif you are worried about symptoms. Suicidal thoughts or actions can be caused\nby things other than medicines. If your child has suicidal thoughts or\nactions, your child’s healthcare provider may check for other causes.\nWhat are the possible side effects of Libervant?\n* The most common side effects of Libervant are sleepiness and headache.\n* These are not all the possible side effects of Libervant.\n* Call your doctor for medical advice about side effects. You may report side\neffects to FDA at 1 800 FDA-1088.\nFor more information about Libervant, talk to your doctor, and see Product\nInformation: Medication Guide and Instructions For Use.\n\nAbout Aquestive Therapeutics, Inc.\nAquestive is a pharmaceutical company advancing medicines to bring meaningful\nimprovement to patients' lives through innovative science and delivery\ntechnologies. The worldwide leader in delivering trusted, quality medications\non oral film, Aquestive operates as both a developer of its own proprietary\nproducts and a Contract Development and Manufacturing Organization (CDMO) for\nlicensees, with its headquarters in New Jersey and U.S.-based manufacturing\nfacilities in Indiana. The Company is the exclusive manufacturer of four\ncommercialized products marketed by its licensees across six continents using\nproprietary, best-in-class technologies like PharmFilm®. Aquestive's\nAdrenaVerse™ platform contains a library of more than 20 epinephrine\nprodrugs enabling the pursuit of various potential allergy and dermatological\nindications. The Company is advancing Anaphylm™ (dibutepinephrine)\nsublingual film for the treatment of severe allergic reactions, including\nanaphylaxis, and AQST-108 (epinephrine) topical gel for various potential\ndermatological conditions, including alopecia areata, atopic dermatitis and\nhypertrophic scars. For more information, visit Aquestive.com and follow us on\nLinkedIn.\n\nNon-GAAP Financial Information\nThis press release and our webcast earnings call regarding our quarterly\nfinancial results contains financial measures that do not comply with U.S.\ngenerally accepted accounting principles (GAAP), such as non-GAAP adjusted\nEBITDA loss, non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses,\nnon-GAAP adjusted costs and expenses and other adjusted expense measures,\nbecause such measures exclude, as applicable, share-based compensation\nexpense, interest expense, interest expense related to the sale of future\nrevenue, interest income, depreciation, amortization, and income taxes. \n\nSpecifically, the Company adjusts net loss for certain non-cash expenses,\nincluding share-based compensation expenses; depreciation and amortization;\nand interest expense related to the sale of future revenue, interest income\nand other income, net and income taxes, with a result of adjusted EBITDA\nloss.  Similarly, manufacture and supply expense, R&D expense, and selling,\ngeneral and administrative expense were adjusted for certain non-cash expenses\nof share-based compensation expense and depreciation and amortization.\nAdjusted EBITDA loss and these non-GAAP expense categories are used as a\nsupplement to the corresponding GAAP measures to provide additional insight\nregarding the Company’s ongoing operating performance. \n\nThese measures supplement the Company’s financial results prepared in\naccordance with GAAP. Aquestive management uses these measures to analyze its\nfinancial results, and its future manufacture and supply expenses, gross\nmargins, R&D expense and selling, general and administrative expense and to\nhelp make managerial decisions. In management’s opinion, these non-GAAP\nmeasures provide added transparency into the operating performance of\nAquestive and added insight into the effectiveness of our operating strategies\nand actions. The Company may provide one or more revenue measures adjusted for\ncertain discrete items, such as fees collected on certain licensed products,\nin order to provide investors added insight into our revenue stream and\nbreakdown, along with providing our GAAP revenue. Such measures are intended\nto supplement, not act as substitutes for, comparable GAAP measures and should\nnot be read as a measure of liquidity for Aquestive. Adjusted EBITDA loss and\nthe other non-GAAP measures are also likely calculated in a way that is not\ncomparable to similarly titled measures reported by other companies.\n\nNon-GAAP Outlook\nIn providing the outlook for non-GAAP adjusted EBITDA and non-GAAP gross\nmargin, we exclude certain items which are otherwise included in determining\nthe comparable GAAP financial measures. In order to inform our outlook\nmeasures of non-GAAP adjusted EBITDA and non-GAAP gross margin, a description\nof the adjustments which have been applicable in determining non-GAAP Adjusted\nEBITDA and non-GAAP gross margin for these periods are reflected in the tables\nbelow. In providing outlook for non-GAAP gross margin, the Company adjusts for\nnon-cash share-based compensation expense and depreciation and amortization.\nThe Company is providing such outlook only on a non-GAAP basis because the\nCompany is unable to predict with reasonable certainty the totality or\nultimate outcome or occurrence of these adjustments for the forward-looking\nperiod such as share-based compensation expense, income tax, amortization, and\ncertain other adjusted items, which can be dependent on future events that may\nnot be reliably predicted. Based on past reported results, where one or more\nof these items have been applicable, such excluded items could be material,\nindividually or in the aggregate, to reported results.\n\nForward-Looking Statement\nCertain statements in this press release include “forward-looking\nstatements” within the meaning of the Private Securities Litigation Reform\nAct of 1995. Words such as “believe,” “anticipate,” “plan,”\n“expect,” “estimate,” “intend,” “may,” “will,” or the\nnegative of those terms, and similar expressions, are intended to identify\nforward-looking statements. These forward-looking statements include, but are\nnot limited to, statements regarding the advancement and related timing of our\nproduct candidate Anaphylm™ (dibutepinephrine) sublingual film through\nclinical development and approval by the FDA, including our ability to address\nthe concerns raised by the FDA in the CRL dated January 30, 2026 and the Type\nA meeting with the FDA, and the timing of our resubmission and FDA review of\nthe NDA; the advancement and related timing of potential international\nregulatory filings and marketing authorizations for Anaphylm outside of the\nU.S.; that Anaphylm will be the first and only oral administration of\nepinephrine, if Anaphylm is approved by the FDA; the advancement, growth and\nrelated timing of our AdrenaVerse™ pipeline epinephrine prodrugs, including\nAQST-108 (epinephrine) topical gel, through clinical development and the FDA\nregulatory approval process, including with respect to the design and timing\nof clinical studies, including those necessary to support the targeted\nindication of alopecia areata, and potential other treatment indications for\nAQST-108; market access for Libervant® (diazepam) buccal film for epilepsy\npatients experiencing acute repetitive seizures (ARS) upon expiration of\norphan drug market exclusivity of an approved FDA product of another company;\nthe future commercial opportunity of Anaphylm, Libervant and AQST-108 should\nthese product candidates be approved by the FDA; the potential benefits our\nproduct candidates could bring to patients, including with respect to\nAnaphylm, Libervant and AQST-108, if these product candidates are approved by\nthe FDA, and acceptance by patients, prescribers and payors of our product\ncandidates as an alternative to existing standards of care for the targeted\nmedical indication of these product candidates; that the Company is\nsufficiently capitalized with sufficient cash in 2026 to perform the necessary\nclinical work and provide the additional information required to address the\nconcerns of the FDA outlined in the CRL and Type A meeting; that our supply\nchain is largely unaffected by implemented and proposed government tariffs and\nwill be reliable and stable in production and global distribution for the near\nterm; our cash requirements, cash funding and cash burn; short-term and longer\nterm liquidity, including access to additional funds if Anaphylm is approved\nby the FDA, and the ability to fund our business operations and key objectives\nin 2026 and beyond, including the launch of Anaphylm, if approved by the FDA;\nour growth and future financial and operating results and financial position,\nincluding with respect to our 2026 financial outlook; and business strategies,\nmarket opportunities, and other statements that are not historical facts. Such\nforward‑looking statements also include statements regarding anticipated\ntimelines, milestones, and guidance relating to regulatory submissions,\nclinical studies, regulatory interactions, and potential approvals, which are\ninherently uncertain and subject to change based on regulatory feedback,\nprotocol alignment, data sufficiency, and other factors outside the\nCompany’s control.\n\nThese forward-looking statements are based on our current expectations and\nbeliefs and are subject to a number of risks and uncertainties that could\ncause actual results to differ materially from those described in the\nforward-looking statements. Such risks and uncertainties include, but are not\nlimited to, risks associated with our development work, including any delays\nor changes to the timing, cost and success of our product development\nactivities and clinical trials and plans for Anaphylm and AQST-108; risk of\ndelays in advancement of the regulatory approval process through the FDA of\nour product candidates Anaphylm, Libervant and AQST-108, or failure to receive\nFDA approval at all of any or all of these product candidates; risk of the\nCompany’s ability to generate sufficient clinical and other human factor\ndata, including with respect to our submission of pharmacokinetic and\npharmacodynamic (PK/PD) comparability data for FDA approval of Anaphylm; risks\nassociated with our ability to address the FDA’s comments on and identified\ndeficiencies in our NDA, including the concerns raised by the FDA in the CRL\nand Type A meeting for Anaphylm, and whether the FDA may request further\ninformation from us (including additional clinical studies), disagree with our\nprotocols, study designs, and findings or otherwise undertake a lengthy review\nof the resubmission of our NDA; challenges regarding the following commercial\nlaunch of Anaphylm, if approved by the FDA; risk of delays in advancement of\nthe regulatory approval process of our product candidates, including Anaphylm\nand Libervant, outside of the U.S., or failure to receive approval at all of\nany or all of these product candidates by such foreign regulatory authorities;\nincluding risks that regulatory authorities outside the United States may\nrequire different, additional, or more extensive clinical, non‑clinical,\nhuman factors, pharmacokinetic, or manufacturing data than anticipated, or may\nnot accept data generated for U.S. regulatory purposes; risk of FDA\ninspections of manufacturing and clinical study sites for any of our product\ncandidates, including Anaphylm, Libervant and AQST-108; risk of government\nshutdowns or actions to reduce government workforces on the ability of the FDA\nto act on a timely basis or at all on the approval of our product candidates,\nincluding Anaphylm, Libervant and AQST-108; risks associated with the success\nof any competing products, including generics; risks and uncertainties\ninherent in commercializing a new product (including technology risks,\nfinancial risks, market risks and implementation risks and regulatory\nlimitations); risk of development of a sales and marketing capability for\ncommercialization of our product candidates, including Anaphylm, Libervant and\nAQST-108, if these product candidates are approved by the FDA; risks\nassociated with the potential impact on the value of the Company of the sale\nor outlicensing of our product candidates, including Anaphylm, Libervant and\nAQST-108; risk of sufficient capital and cash resources, including sufficient\naccess to available debt and equity financing, including under our debt and\nATM facilities, and revenues from operations, to satisfy all of our short-term\nand longer-term liquidity and cash requirements to support our business\noperations, key initiatives and growth strategy, and other cash needs, at the\ntimes and in the amounts needed, and to fund future clinical development and\ncommercial activities for our product candidates, including Anaphylm,\nLibervant and AQST-108, should these product candidates be approved by the FDA\n, including risks that assumptions underlying projected cash runway,\nliquidity, and capital sufficiency may prove incorrect due to changes in\noperating plans, regulatory requirements, timing or scope of clinical\nactivities, market conditions, or the availability, timing, and terms of\nfinancing; risk of the impact of our obligations under the Company's Purchase\nAgreement and the Royalty Rights Agreement with third parties, each of which\nagreements requires the Company to make payments to each counterparty thereof,\nrespectively, of a portion of our revenues, on our ability to contribute to\nthe funding of our operations; risk that our manufacturing capabilities will\nbe sufficient to support demand of our product candidates in the U.S. and\nabroad, including Anaphylm and Libervant, if such product candidates should be\napproved by the FDA and other regulatory authorities, and our licensed\nproducts in the U.S. and abroad; risk of eroding market share for Suboxone®\nas a sunsetting product, which accounts for a substantial part of our current\noperating revenue; risk of default of our debt instruments; risks related to\nthe outsourcing of certain sales, marketing and other operational and staff\nfunctions to third parties; risk of the rate and degree of market acceptance\nin the U.S. and abroad of our product candidates, including Anaphylm,\nLibervant, and AQST-108 should these product candidates be approved by the FDA\nand other regulatory authorities, and for our licensed products in the U.S.\nand abroad; risk associated with the size and growth of our product markets\nand expected related revenues and sales; risk associated with our compliance\nwith all FDA and other governmental and customer requirements for our\nmanufacturing facilities; risks associated with intellectual property rights\nand infringement claims relating to our products; risk that our patent\napplications for our product candidates, including for Anaphylm, will not be\ntimely issued, or issued at all, by the U.S. Patent and Trademark Office or,\nif issued, will be sufficient to provide long-term commercial success of these\nproduct candidates; risk of unexpected patent developments; risk of\nlegislation and regulatory actions and changes in laws or regulations\naffecting our business, including relating to our products and product\ncandidates and product pricing, reimbursement or access therefor; risk of loss\nof significant customers; risks related to claims and legal proceedings\nagainst us including patent infringement, securities, business torts,\ninvestigative, product safety or efficacy and antitrust litigation matters;\nrisk of product recalls and withdrawals; risks related to any disruptions in\nour information technology networks and systems, including the impact of\ncybersecurity attacks; risk of increased cybersecurity attacks and data\naccessibility disruptions, including due to remote working arrangements; risk\nof adverse developments affecting the financial services industry; risks\nrelated to inflation and changing interest rates; risks related to the impact\nof pandemic diseases on our business; risks and uncertainties related to\ngeneral economic, political (including the Ukraine, Israel and Iran wars and\nother acts of war and terrorism), business, industry, regulatory, financial\nand market conditions and other unusual items; risks related to uncertainty\nabout presidential administration initiatives and their impact on our\nbusiness, including imposition of government tariffs and other trade\nrestrictions; and other uncertainties affecting the Company including those\ndescribed in the \"Risk Factors\" section and in other sections included in the\nCompany’s Annual Report on 10-K, Quarterly Reports on Form 10-Q, and Current\nReports on Form 8-K filed with the U.S. Securities and Exchange Commission.\nGiven those uncertainties, you should not place undue reliance on these\nforward-looking statements, which speak only as of the date made. All\nsubsequent forward-looking statements attributable to the Company or any\nperson acting on its behalf are expressly qualified in their entirety by this\ncautionary statement. The Company assumes no obligation to update\nforward-looking statements or outlook or guidance after the date of this press\nrelease whether as a result of new information, future events or otherwise,\nexcept as may be required by applicable law.\n\n           \n\nLibervant(®), PharmFilm(®), Sympazan(®) and the Aquestive logo are\nregistered trademarks of Aquestive Therapeutics, Inc. All other registered\ntrademarks referenced herein are the property of their respective owners.\n\nInvestor inquiries:\nAstr Partners\nBrian Korb\nbrian.korb@astrpartners.com \n\n AQUESTIVE THERAPEUTICS, INC.                                                                                                                                                                                                        \n Condensed Balance Sheets                                                                                                                                                                                                            \n (In thousands, except share and per share amounts)                                                                                                                                                                                  \n (Unaudited)                                                                                                                                                                                                                         \n                                                                                                                                                                                                                                     \n                                                                                                                                                                                 March 31, 2026            December 31, 2025         \n Assets                                                                                                                                                                                                                              \n Current assets:                                                                                                                                                                                                                     \n Cash and cash equivalents                                                                                                                                                       $      110,734            $       121,169           \n Trade and other receivables, net                                                                                                                                                       6,867                      17,763            \n Inventories                                                                                                                                                                            8,066                      6,169             \n Prepaid expenses and other current assets                                                                                                                                              4,516                      4,168             \n Total current assets                                                                                                                                                                   130,183                    149,269           \n Property and equipment, net                                                                                                                                                            3,839                      3,893             \n Right-of-use assets, net                                                                                                                                                               4,468                      4,621             \n Other non-current assets                                                                                                                                                               2,635                      2,642             \n Total assets                                                                                                                                                                    $      141,125            $       160,425           \n                                                                                                                                                                                                                                     \n Liabilities and stockholders’ deficit                                                                                                                                                                                               \n Current liabilities:                                                                                                                                                                                                                \n Accounts payable                                                                                                                                                                $      11,889             $       29,862            \n Accrued expenses                                                                                                                                                                       3,449                      5,029             \n Lease liabilities, current                                                                                                                                                             662                        631               \n Deferred revenue, current                                                                                                                                                              1,092                      1,092             \n Liability related to the sale of future revenue, current                                                                                                                               1,000                      1,000             \n Loans payable, current                                                                                                                                                                 13,661                     9,994             \n Total current liabilities                                                                                                                                                              31,753                     47,608            \n Notes payable, net                                                                                                                                                                     25,099                     27,519            \n Royalty obligations, net                                                                                                                                                               26,914                     25,941            \n Liability related to the sale of future revenue, net                                                                                                                                   62,083                     62,023            \n Lease liabilities                                                                                                                                                                      4,159                      4,337             \n Deferred revenue, net of current portion                                                                                                                                               19,118                     19,390            \n Other non-current liabilities                                                                                                                                                          6,053                      7,269             \n Total liabilities                                                                                                                                                                      175,179                    194,087           \n Contingencies                                                                                                                                                                                                                       \n                                                                                                                                                                                                                                     \n Stockholders’ deficit:                                                                                                                                                                                                              \n Common stock, $0.001 par value. Authorized 250,000,000 shares; 124,284,542 and 122,044,299 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively         124                        122               \n Additional paid-in capital                                                                                                                                                             420,877                    413,214           \n Accumulated deficit                                                                                                                                                                    (455,055  )                (446,998  )       \n Total stockholders’ deficit                                                                                                                                                            (34,054   )                (33,662   )       \n Total liabilities and stockholders’ deficit                                                                                                                                     $      141,125            $       160,425           \n                                                                                                                                                                                                                                     \n\n\n\n AQUESTIVE THERAPEUTICS, INC.                                                                                        \n Condensed Statements of Operations and Comprehensive Loss                                                           \n (In thousands, except share and per share data amounts)                                                             \n (Unaudited)                                                                                                         \n                                                                                                                     \n                                                         Three Months Ended March 31,                                \n                                                                2026                              2025               \n Revenues                                                $      14,446                     $      8,720              \n Costs and expenses:                                                                                                 \n Manufacture and supply                                         3,469                             3,652              \n Research and development                                       4,204                             5,361              \n Selling, general and administrative                            10,977                            19,072             \n Total costs and expenses                                       18,650                            28,085             \n Loss from operations                                           (4,204       )                    (19,365     )      \n Other income/(expenses):                                                                                            \n Interest expense                                               (2,903       )                    (2,782      )      \n Interest expense related to royalty obligations                (973         )                    (1,437      )      \n Interest expense related to the sale of future revenue         (60          )                    (59         )      \n Interest income and other income, net                          83                                713                \n Net loss before income taxes                                   (8,057       )                    (22,930     )      \n Net loss                                                $      (8,057       )             $      (22,930     )      \n Comprehensive loss                                      $      (8,057       )             $      (22,930     )      \n                                                                                                                     \n Loss per share attributable to common stockholders:                                                                 \n Basic and diluted (in dollars per share)                $      (0.07        )             $      (0.24       )      \n Weighted average common shares outstanding:                                                                         \n Basic and diluted (in shares)                                  122,609,995                       95,497,056         \n                                                                                                                     \n\nAQUESTIVE THERAPEUTICS, INC.\nReconciliation of Non-GAAP Adjustments - Net Loss to Non-GAAP Adjusted EBITDA\n(In Thousands)\n(Unaudited)\n\n                                                                    Three Months Ended March 31,                        \n                                                                           2026                         2025            \n GAAP net loss                                                      $      (8,057  )             $      (22,930  )      \n Share-based compensation expense                                          2,318                        1,587           \n Interest expense                                                          2,903                        2,782           \n Interest expense related to royalty obligations                           973                          1,437           \n Interest expense related to the sale of future revenue                    60                           59              \n Interest income and other income, net                                     (83     )                    (713     )      \n Depreciation and Amortization                                             113                          139             \n Total non-GAAP adjustments                                         $      6,284                 $      5,291           \n Non-GAAP adjusted EBITDA                                           $      (1,773  )             $      (17,639  )      \n Excluding Non-GAAP adjusted R&D expenses                                  (3,954  )                    (5,016   )      \n Non-GAAP adjusted EBITDA excluding Non-GAAP adjusted R&D expenses  $      2,181                 $      (12,623  )      \n                                                                                                                        \n\n\n\n AQUESTIVE THERAPEUTICS, INC.                                                                                       \n Reconciliation of Non-GAAP Adjustments - GAAP Expenses to Non-GAAP Adjusted Expenses                               \n (In Thousands, except percentages)                                                                                 \n (Unaudited)                                                                                                        \n                                                                                                                    \n                                                                 Three Months Ended March 31,                       \n                                                                        2026                         2025           \n Total costs and expenses                                        $      18,650                $      28,085         \n Non-GAAP adjustments:                                                                                              \n Share-based compensation expense                                       (2,318  )                    (1,587  )      \n Depreciation and amortization                                          (113    )                    (139    )      \n Non-GAAP adjusted costs and expenses                            $      16,219                $      26,359         \n                                                                                                                    \n                                                                                                                    \n Manufacture and Supply Expenses                                 $      3,469                 $      3,652          \n Gross Margin on total revenue                                          76      %                    58      %      \n Non-GAAP adjustments:                                                                                              \n Share-based compensation expense                                       (69     )                    (100    )      \n Depreciation and amortization                                          (86     )                    (115    )      \n Non-GAAP adjusted manufacture and supply expenses               $      3,314                 $      3,437          \n Non-GAAP Gross Margin on total revenue                                 77      %                    61      %      \n                                                                                                                    \n                                                                                                                    \n Research and Development Expenses                               $      4,204                 $      5,361          \n Non-GAAP adjustments:                                                                                              \n Share-based compensation expense                                       (236    )                    (330    )      \n Depreciation and amortization                                          (14     )                    (15     )      \n Non-GAAP adjusted research and development expenses             $      3,954                 $      5,016          \n                                                                                                                    \n                                                                                                                    \n Selling, General and Administrative Expenses                    $      10,977                $      19,072         \n Non-GAAP adjustments:                                                                                              \n Share-based compensation expense                                       (2,013  )                    (1,157  )      \n Depreciation and amortization                                          (13     )                    (9      )      \n Non-GAAP adjusted selling, general and administrative expenses  $      8,951                 $      17,906         \n\n\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/e0b65f93-9565-43d7-a6ff-88b8cbd6adea)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNXcbYQPp","title":"Aquestive Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update","author":"Globe Newswire","ticker":"AQST","created":"2026-05-13T20:01:01.344Z","tickers":["AQST"],"exchange":"NASDAQ","article_body":"* Reaffirms guidance to resubmit Anaphylm™ (dibutepinephrine) sublingual\nfilm NDA in Q3 2026\n* Affirms existing clinical data is sufficient for submitting regulatory\napplications in Canada, European Union, and the United Kingdom\n* Completed AQST-108 phase 1 study in subjects with androgenic alopecia with\nno safety issues observed\n* Entered into a $150 million debt facility with Oaktree Capital Management,\nL.P.\n* Company to host investor call on May 14, 2026, at 8:00am ET\nWARREN, N.J., May 13, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc.\n(NASDAQ: AQST) (\"Aquestive\" or the \"Company\"), a pharmaceutical company\nadvancing medicines to bring meaningful improvement to patients' lives through\ninnovative science and delivery technologies, today announced financial\nresults for the first quarter ended March 31, 2026, and provided a strategic\nbusiness update.\n\n“We made rapid and meaningful progress in the first quarter,” said Daniel\nBarber, President and Chief Executive Officer of Aquestive. “We successfully\ncompleted our Type A meeting with the FDA, aligning on the study designs\nneeded to support resubmission of the Anaphylm NDA, which we continue to\ntarget for the third quarter of 2026. In parallel, our commercial readiness\nefforts continue. We are making the most of this time by driving awareness of\nAnaphylm among healthcare professionals. We are building momentum for our\nAdrenaVerse™ platform and are excited by the recent results from our\nAQST-108 phase 1 study. Financially, we have taken steps to further strengthen\nour balance sheet and extend our cash runway, and we believe we are\nwell-positioned to execute on our key objectives in 2026 and beyond.”\n\nAnaphylm™ (dibutepinephrine) sublingual film\nAnaphylm is a no-needle, no-device epinephrine product candidate being\ndeveloped for the treatment of Type I allergic reactions, including\nanaphylaxis. The Company believes Anaphylm has the potential to be the first\nand only non-invasive, orally delivered epinephrine product, if approved by\nthe U.S. Food and Drug Administration (FDA).\n\nIn the first quarter of 2026, Aquestive successfully completed its Type A\nmeeting with the FDA, aligning on the study designs for both the human factors\nvalidation and pharmacokinetics (PK) studies required to address the\ndeficiencies identified in the Complete Response Letter (CRL) from the FDA\ndated January 30, 2026. The Company reaffirms its guidance to resubmit the\nAnaphylm New Drug Application (NDA) in the third quarter of 2026, subject to\ncompletion of the required studies and expected FDA response timelines. As\npreviously disclosed, the CRL did not identify any chemistry, manufacturing,\nor controls (CMC) deficiencies, and clinical results supporting comparability\nto auto-injectors were not questioned. The Company will request an accelerated\nreview upon resubmission, though no expedited review can be guaranteed.\n\nIn February 2026, Aquestive presented data at the American Academy of Allergy,\nAsthma & Immunology (AAAAI) Annual Meeting. Data presented demonstrated that\nAnaphylm achieved clinically relevant epinephrine plasma concentrations\nwithout the diastolic blood pressure dip associated with auto-injector\nadministration, providing further clinical differentiation. Feedback from key\nopinion leaders (KOLs) and the broader allergy community continues to be\npositive, and physician enthusiasm for a non-invasive, non-device epinephrine\ntreatment option remains strong.\n\nAquestive continues to advance its global regulatory strategy for Anaphylm.\nThe Company remains on track to submit regulatory applications in Canada, the\nEuropean Union and United Kingdom by utilizing its existing clinical data. The\nCompany recently completed a meeting with the Medicines and Healthcare\nproducts Agency, which is the health regulatory agency for the United Kingdom.\nIn addition, the Company submitted its initial Pediatric Investigation Plan\n(PIP) to the European Medicines Agency (EMA), an important step in preparing\nfor full submission of the Company's Market Authorization Application for the\nEuropean Union.\n\nAquestive has advanced its commercial infrastructure in preparation for a\npotential Anaphylm approval. The Company has expanded its planned field force\nto approximately 75 sales representatives - a 50% increase from its prior\nguidance of 50 representatives - better positioning the Company to reach\npatients and healthcare providers across the country. Current priorities\ninclude continued engagement with healthcare professionals through our\nrecently expanded Medical Affairs team to increase Anaphylm awareness, market\naccess preparation ahead of a potential approval, and active collaboration\nwith leading patient advocacy organizations in the allergy community.\n\nAQST-108 (epinephrine) topical gel\nAQST-108 is a topical epinephrine prodrug gel product candidate being\nevaluated for potential dermatologic indications. Aquestive made meaningful\nclinical development progress with AQST-108 in the first quarter of 2026. The\nCompany recently completed its second phase 1 clinical trial, which was\ndesigned to further characterize the safety, tolerability, and pharmacologic\nprofile of the topical epinephrine prodrug gel. There were no drug related\nadverse events observed in the study and the data did not indicate signs of\nsystemic absorption. In addition, Aquestive identified a biomarker signal\nthrough the suppression of the cytokine thymic stromal lymphopoietin (TSLP)\nwhen compared to placebo. The TSLP signaling pathway involves the activation\nof Janus Kinase (JAK) 1 and JAK2. This signal will be explored further in\nupcoming studies.\n\nBuilding on the IND opening and supportive FDA feedback received in December\n2025, Aquestive continues to believe AQST-108 has potential application across\na variety of dermatological conditions, including alopecia areata, atopic\ndermatitis, rosacea, and psoriasis. Aquestive plans to further study AQST-108\nby utilizing an atopic dermatitis study design in the upcoming months. This\ndisciplined, data-driven approach is consistent with the Company’s strategy\nof maximizing the value of the AdrenaVerse™ platform while maintaining focus\non the Anaphylm NDA resubmission.\n\nAlopecia areata remains a significant unmet need, affecting an estimated 6.7\nmillion people in the United States, with 43% classified as severe. JAK\ninhibitors, the current standard of care, are systemic agents carrying black\nbox warnings in a market currently valued at over $1 billion. AQST-108’s\ntopical, localized delivery profile may provide a differentiated option for\nthese patients, if clinical development is successful.\n\nAtopic dermatitis affects approximately 7%–10% of U.S. adults and 10–20%\nof children, making it one of the most common chronic inflammatory skin\ndiseases in the U.S.\n\nAquestive’s AdrenaVerse platform comprises approximately 20 epinephrine\nprodrugs designed to enable control of absorption and conversion rates across\na range of dosage forms and delivery sites. The Company remains excited by the\nAdrenaVerse platform’s long-term potential to address multiple indications.\n\nDebt Refinancing\nAquestive entered into a new $150 million debt facility with Oaktree Capital\nManagement, L.P., a leading life sciences debt provider. Refinancing the\nCompany's existing debt will save the Company $45 million in principal\npayments over the next three years. Further, this new debt facility provides\nthe Company with improved interest rate terms and principal payments that will\nnot begin until maturity in 2031. In addition to the $55.0 million provided at\nsigning, Aquestive will have the ability to access $20 million of capital in\nthe event of FDA approval of Anaphylm. A third tranche of $25.0 million will\nbe available upon the achievement of specified sales milestones, with the\nfinal tranche of up to $50.0 million available with the mutual consent of the\nlenders and the Company. This refinancing allows the Company to achieve one of\nthe pre-approval requirements for Aquestive's $75 million strategic funding\nagreement with funds managed by RTW Investments, LP. With the new debt\nfacility and the strategic RTW funding agreement, the Company expects to have\n$150 million in cash and cash equivalents for the launch of Anaphylm, if\napproved by the FDA in 2027.\n\nCommercial Collaborations and Other \nAquestive continues to manufacture products for the licensing and supply\ncollaborations that it has established. The Company manufactured approximately\n33 million doses in the first quarter 2026, compared to approximately\n27 million doses in the first quarter 2025. The Company continues to\nmanufacture Indivior’s Suboxone(® )Sublingual Film product and the\nCompany's other global collaborations, including Sympazan(® )(clobazam) oral\nfilm product for Cosette Pharmaceuticals, Inc. in the U.S., Ondif(®)\n(Ondansetron) oral film product for Hypera Pharma in Brazil and Emylif®\n(riluzole) oral film product by Zambon S.p.A in Europe. Aquestive’s\nmanufacturing business remains steady.\n\nOn April 8, 2026, Cosette Pharmaceuticals, Inc. (\"Cosette\"), a United\nStates-based, branded specialty pharmaceutical company, acquired the rights to\nSympazan for the treatment of seizures associated with Lennox-Gastaut Syndrome\nin patients two years of age and older, from Assertio Holdings, Inc.\n(\"Assertio\"), including Assertio's rights under our License Agreement for\nSympazan with Otter Pharmaceuticals, LLC, a subsidiary of Assertio (the\n\"Assertio License Agreement\"). Cosette will continue to purchase Sympazan(®\n)(clobazam) Oral Film Product and pay royalties and milestones to Aquestive\nunder the Assertio License Agreement.\n\nThe Company, being a U.S. based manufacturer with intellectual property\ndomiciled in the U.S., confirms that its supply chain currently remains\nlargely unaffected by both implemented and proposed government tariffs,\nproviding continued reliability and stability in production and global\ndistribution for the near term.\n\nSales of royalty-based products, inclusive of Sympazan, contributed to the\nCompany's revenue in the first quarter of 2025.\n\nLibervant(®) (diazepam) buccal film remains tentatively approved until\nJanuary 2027, the scheduled date of expiration of U.S. market orphan drug\nexclusivity of an FDA approved product of another company. Aquestive continues\nto believe that expanding patient access to non-invasive seizure rescue\ntherapies is vital and remains committed to putting Libervant in the hands of\npatients when granted full approval for U.S. market access by the FDA.\n\nFirst Quarter 2026 Financials\nTotal revenues increased to $14.4 million in the first quarter 2026 from $8.7\nmillion in the first quarter 2025. The 66% increase was primarily driven by\nincreases in license and royalty revenue and increases in manufacture and\nsupply revenue.\n\nLicense and royalty revenue increased to $5.4 million in the first quarter\n2026 from $0.8 million in the first quarter 2025, primarily due to royalty\nrevenue from Zevra.\n\nManufacture and supply revenue increased to $8.8 million in the first quarter\n2026 from $7.2 million in the first quarter 2025, primarily due to increases\nin Suboxone revenues, partially offset by lower Ondif revenues.\n\nResearch and development expenses decreased to $4.2 million in the first\nquarter 2026 from $5.4 million in the first quarter 2025. The decrease in\nresearch and development expenses was primarily due to lower clinical trial\ncosts associated with the Anaphylm development program, partially offset by\nincreases in R&D personnel costs.\n\nSelling, general and administrative expenses decreased to $11.0 million in the\nfirst quarter of 2026 from $19.1 million in the first quarter of 2025. The\ndecrease primarily represents the one-time Anaphylm PDUFA fee of $4.3 million\nin the prior year period, lower legal fees of approximately $3.4 million,\nlower commercial spending of approximately $2.0 million, and lower regulatory\nand licensing fees of approximately $0.5 million, partially offset by higher\nseverance costs of approximately $0.6 million, higher personnel costs of\napproximately $0.5 million and higher share-based compensation expenses of\napproximately $0.5 million.\n\nAquestive’s net loss for the first quarter 2026 was $8.1 million, or $0.07\nfor both basic and diluted loss per share, compared to the net loss in the\nfirst quarter 2025 of $22.9 million, or $0.24 for both basic and diluted loss\nper share. The decrease in net loss was primarily driven by decreases in\nselling, general and administrative expenses and research and development\nexpenses and increases in revenues, partially offset by decreases in interest\nincome and other income, net.\n\nNon-GAAP adjusted EBITDA loss was $1.7 million in the first quarter 2026,\ncompared to non-GAAP adjusted EBITDA loss of $17.6 million in the first\nquarter 2025.\n\nCash and cash equivalents were $110.7 million as of March 31, 2026.\n\n2026 Outlook\nAquestive's full-year 2026 financial guidance remains unchanged.\n\nThe Company expects:\n\n                                              Guidance    \n Total revenue (in millions)                  $46 to $50  \n Non-GAAP adjusted EBITDA loss (in millions)  $35 to $30  \n                                                          \n\nTomorrow’s Conference Call and Webcast Reminder\nThe Company will host a conference call at 8:00 a.m. ET on Thursday, May 14,\n2026.\n\nIn order to participate, please register in advance here to obtain a local or\ntoll-free phone number and your personal pin.\n\nA live webcast of the call will be available on Aquestive’s website at:\nFirst Quarter 2026 Earnings Call.\n\nAbout Anaphylm™\nAnaphylm™ (dibutepinephrine) sublingual film is a polymer matrix-based\nepinephrine prodrug product. Anaphylm is similar in size to a postage stamp,\nweighs less than an ounce, and begins to dissolve on contact. No water or\nswallowing is required for administration. The primary packaging for Anaphylm\nis thinner and smaller than an average credit card, can be carried in a\npocket, and is designed to withstand weather excursions such as exposure to\nrain and/or sunlight. The Anaphylm trade name for AQST-109 has been\nconditionally approved by the FDA. Final approval of the Anaphylm proprietary\nname is conditioned on FDA approval of the product candidate.\n\nAbout AQST-108\nAQST-108 (epinephrine) topical gel is a topically delivered adrenergic agonist\nprodrug product candidate. Aquestive completed a first-in-human study for\nAQST-108 without any serious or topical adverse events observed. AQST-108 is\nbased on Aquestive’s AdrenaVerse™ platform which contains a library of\nover twenty epinephrine prodrug products intended to control absorption and\nconversion rates across a variety of possible dosage forms and delivery sites.\n\nAbout Libervant®\nLibervant(®) (diazepam) buccal film is a buccally, or inside of the cheek,\nadministered film formulation of diazepam, a benzodiazepine intended for the\nacute treatment of intermittent, stereotypic episodes of frequent seizure\nactivity (i.e., seizure clusters, acute repetitive seizures) that are distinct\nfrom a patient’s usual seizure pattern in patients with epilepsy. Aquestive\ndeveloped Libervant as an alternative to the device-based products currently\navailable for patients with refractory epilepsy, including a rectal gel and\nnasal spray products. The FDA approval for U.S. market access received in\nApril 2024 for Libervant was for these epilepsy patients between two and five\nyears of age. However, the FDA converted this approval to a \"tentative\napproval\" due to a subsequent court ruling finding that the FDA did not have\nauthority to approve Libervant for U.S. market access for patients aged\nbetween two and five years due to the existing orphan drug market exclusivity\ngranted by the FDA to an intranasal spray of another company. The FDA granted\ntentative approval in August 2022 for Libervant for treatment of these\nepilepsy patients twelve years of age and older. U.S. market access for\nLibervant patients is currently subject to the expiration of the existing\norphan drug market exclusivity of the previously FDA approved drug scheduled\nto occur in January 2027.\n\nImportant Safety Information\nDo not give Libervant to your child between the ages of two and five if your\nchild is allergic to diazepam or any of the ingredients in Libervant or has an\neye problem called acute narrow angle glaucoma.\n\nWhat is the most important information I should know about Libervant?\n* Libervant is a benzodiazepine medicine. Taking benzodiazepines with opioid\nmedicines, alcohol, or other central nervous system (CNS) depressants\n(including street drugs) can cause severe drowsiness, breathing problems\n(respiratory depression), coma, and death. Get emergency help right away if\nany of the following happens: * shallow or slowed breathing,\n* breathing stops (which may lead to the heart stopping),\n* excessive sleepiness (sedation).\nDo not allow your child to drive a motor vehicle, operate heavy machinery, or\nride a bicycle until you know how taking Libervant with opioids affects your\nchild.\n* Risk of abuse, misuse, and addiction. Libervant is used in children 2 to 5\nyears of age. The unapproved use of Libervant has a risk for abuse, misuse,\nand addiction, which can lead to overdose and serious side effects including\ncoma and death.\n* Serious side effects including coma and death have happened in people who\nhave abused or misused benzodiazepines, including diazepam (the active\ningredient in Libervant). These serious side effects may also include\ndelirium, paranoia, suicidal thoughts or actions, seizures, and difficulty\nbreathing. Call your child’s healthcare provider or go to the nearest\nhospital emergency room right away if you get any of these serious side\neffects. * Your child can develop an addiction even if your child takes\nLibervant as prescribed by your child’s healthcare provider.\n* Give Libervant exactly as your child’s healthcare provider prescribed.\n* Do not share Libervant with other people.\n* Keep Libervant in a safe place and away from children.\n \n* Physical dependence and withdrawal reactions. Libervant is intended for use\nif needed in order to treat higher than usual seizure activity.\nBenzodiazepines, including Libervant, can cause physical dependence and\nwithdrawal reactions, especially if used daily. Libervant is not intended for\ndaily use. * Do not suddenly stop giving Libervant to your child without\ntalking to your child’s healthcare provider. Stopping Libervant suddenly can\ncause serious and life-threatening side effects, including, unusual movements,\nresponses, or expressions, seizures that will not stop (status epilepticus),\nsudden and severe mental or nervous system changes, depression, seeing or\nhearing things that others do not see or hear, homicidal thoughts, an extreme\nincrease in activity or talking, losing touch with reality, and suicidal\nthoughts or actions. Call your child’s healthcare provider or go to the\nnearest hospital emergency room right away if your child gets any of these\nsymptoms.\n* Some people who suddenly stop benzodiazepines have symptoms that can last\nfor several weeks to more than 12 months including, anxiety, trouble\nremembering, learning, or concentrating, depression, problems sleeping,\nfeeling like insects are crawling under your skin, weakness, shaking, muscle\ntwitching, burning, or prickling feeling in your hands, arms, legs or feet,\nand ringing in your ears.\n* Physical dependence is not the same as drug addiction. Your child’s\nhealthcare provider can tell you more about the differences between physical\ndependence and drug addiction.\n \n* Do not give your child more Libervant than prescribed or give Libervant more\noften than prescribed.\nLibervant can make your child sleepy or dizzy and can slow your child’s\nthinking and motor skills.\n* Do not allow your child to drive a motor vehicle, operate machinery, or ride\na bicycle until you know how Libervant affects your child.\n* Do not give other drugs that may make your child sleepy or dizzy while\ntaking Libervant without first talking to your child’s healthcare provider.\nWhen taken with drugs that cause sleepiness or dizziness, Libervant may make\nyour child’s sleepiness or dizziness much worse.\nLike other antiepileptic medicines, Libervant may cause suicidal thoughts or\nactions in a small number of people, about 1 in 500.\n* Call a healthcare provider right away if your child has any of these\nsymptoms, especially if they are new, worse, or worry you: * thoughts about\nsuicide or dying\n* new or worse depression\n* feeling agitated or restless\n* trouble sleeping (insomnia)\n* acting aggressive, being angry or violent\n* other unusual changes in behavior or mood\n* attempts to commit suicide\n* new or worse anxiety or irritability        \n* an extreme increase in activity and talking (mania)\n* new or worse panic attacks\n* acting on dangerous impulses\n \n* Pay attention to any changes, especially sudden changes in mood, behaviors,\nthoughts, or feelings.\n* Keep all follow-up visits with your child’s healthcare provider as\nscheduled.\n* Call your child’s healthcare provider between visits as needed, especially\nif you are worried about symptoms. Suicidal thoughts or actions can be caused\nby things other than medicines. If your child has suicidal thoughts or\nactions, your child’s healthcare provider may check for other causes.\nWhat are the possible side effects of Libervant?\n* The most common side effects of Libervant are sleepiness and headache.\n* These are not all the possible side effects of Libervant.\n* Call your doctor for medical advice about side effects. You may report side\neffects to FDA at 1 800 FDA-1088.\nFor more information about Libervant, talk to your doctor, and see Product\nInformation: Medication Guide and Instructions For Use.\n\nAbout Aquestive Therapeutics, Inc.\nAquestive is a pharmaceutical company advancing medicines to bring meaningful\nimprovement to patients' lives through innovative science and delivery\ntechnologies. The worldwide leader in delivering trusted, quality medications\non oral film, Aquestive operates as both a developer of its own proprietary\nproducts and a Contract Development and Manufacturing Organization (CDMO) for\nlicensees, with its headquarters in New Jersey and U.S.-based manufacturing\nfacilities in Indiana. The Company is the exclusive manufacturer of four\ncommercialized products marketed by its licensees across six continents using\nproprietary, best-in-class technologies like PharmFilm®. Aquestive's\nAdrenaVerse™ platform contains a library of more than 20 epinephrine\nprodrugs enabling the pursuit of various potential allergy and dermatological\nindications. The Company is advancing Anaphylm™ (dibutepinephrine)\nsublingual film for the treatment of severe allergic reactions, including\nanaphylaxis, and AQST-108 (epinephrine) topical gel for various potential\ndermatological conditions, including alopecia areata, atopic dermatitis and\nhypertrophic scars. For more information, visit Aquestive.com and follow us on\nLinkedIn.\n\nNon-GAAP Financial Information\nThis press release and our webcast earnings call regarding our quarterly\nfinancial results contains financial measures that do not comply with U.S.\ngenerally accepted accounting principles (GAAP), such as non-GAAP adjusted\nEBITDA loss, non-GAAP adjusted EBITDA loss excluding adjusted R&D expenses,\nnon-GAAP adjusted costs and expenses and other adjusted expense measures,\nbecause such measures exclude, as applicable, share-based compensation\nexpense, interest expense, interest expense related to the sale of future\nrevenue, interest income, depreciation, amortization, and income taxes. \n\nSpecifically, the Company adjusts net loss for certain non-cash expenses,\nincluding share-based compensation expenses; depreciation and amortization;\nand interest expense related to the sale of future revenue, interest income\nand other income, net and income taxes, with a result of adjusted EBITDA\nloss.  Similarly, manufacture and supply expense, R&D expense, and selling,\ngeneral and administrative expense were adjusted for certain non-cash expenses\nof share-based compensation expense and depreciation and amortization.\nAdjusted EBITDA loss and these non-GAAP expense categories are used as a\nsupplement to the corresponding GAAP measures to provide additional insight\nregarding the Company’s ongoing operating performance. \n\nThese measures supplement the Company’s financial results prepared in\naccordance with GAAP. Aquestive management uses these measures to analyze its\nfinancial results, and its future manufacture and supply expenses, gross\nmargins, R&D expense and selling, general and administrative expense and to\nhelp make managerial decisions. In management’s opinion, these non-GAAP\nmeasures provide added transparency into the operating performance of\nAquestive and added insight into the effectiveness of our operating strategies\nand actions. The Company may provide one or more revenue measures adjusted for\ncertain discrete items, such as fees collected on certain licensed products,\nin order to provide investors added insight into our revenue stream and\nbreakdown, along with providing our GAAP revenue. Such measures are intended\nto supplement, not act as substitutes for, comparable GAAP measures and should\nnot be read as a measure of liquidity for Aquestive. Adjusted EBITDA loss and\nthe other non-GAAP measures are also likely calculated in a way that is not\ncomparable to similarly titled measures reported by other companies.\n\nNon-GAAP Outlook\nIn providing the outlook for non-GAAP adjusted EBITDA and non-GAAP gross\nmargin, we exclude certain items which are otherwise included in determining\nthe comparable GAAP financial measures. In order to inform our outlook\nmeasures of non-GAAP adjusted EBITDA and non-GAAP gross margin, a description\nof the adjustments which have been applicable in determining non-GAAP Adjusted\nEBITDA and non-GAAP gross margin for these periods are reflected in the tables\nbelow. In providing outlook for non-GAAP gross margin, the Company adjusts for\nnon-cash share-based compensation expense and depreciation and amortization.\nThe Company is providing such outlook only on a non-GAAP basis because the\nCompany is unable to predict with reasonable certainty the totality or\nultimate outcome or occurrence of these adjustments for the forward-looking\nperiod such as share-based compensation expense, income tax, amortization, and\ncertain other adjusted items, which can be dependent on future events that may\nnot be reliably predicted. Based on past reported results, where one or more\nof these items have been applicable, such excluded items could be material,\nindividually or in the aggregate, to reported results.\n\nForward-Looking Statement\nCertain statements in this press release include “forward-looking\nstatements” within the meaning of the Private Securities Litigation Reform\nAct of 1995. Words such as “believe,” “anticipate,” “plan,”\n“expect,” “estimate,” “intend,” “may,” “will,” or the\nnegative of those terms, and similar expressions, are intended to identify\nforward-looking statements. These forward-looking statements include, but are\nnot limited to, statements regarding the advancement and related timing of our\nproduct candidate Anaphylm™ (dibutepinephrine) sublingual film through\nclinical development and approval by the FDA, including our ability to address\nthe concerns raised by the FDA in the CRL dated January 30, 2026 and the Type\nA meeting with the FDA, and the timing of our resubmission and FDA review of\nthe NDA; the advancement and related timing of potential international\nregulatory filings and marketing authorizations for Anaphylm outside of the\nU.S.; that Anaphylm will be the first and only oral administration of\nepinephrine, if Anaphylm is approved by the FDA; the advancement, growth and\nrelated timing of our AdrenaVerse™ pipeline epinephrine prodrugs, including\nAQST-108 (epinephrine) topical gel, through clinical development and the FDA\nregulatory approval process, including with respect to the design and timing\nof clinical studies, including those necessary to support the targeted\nindication of alopecia areata, and potential other treatment indications for\nAQST-108; market access for Libervant® (diazepam) buccal film for epilepsy\npatients experiencing acute repetitive seizures (ARS) upon expiration of\norphan drug market exclusivity of an approved FDA product of another company;\nthe future commercial opportunity of Anaphylm, Libervant and AQST-108 should\nthese product candidates be approved by the FDA; the potential benefits our\nproduct candidates could bring to patients, including with respect to\nAnaphylm, Libervant and AQST-108, if these product candidates are approved by\nthe FDA, and acceptance by patients, prescribers and payors of our product\ncandidates as an alternative to existing standards of care for the targeted\nmedical indication of these product candidates; that the Company is\nsufficiently capitalized with sufficient cash in 2026 to perform the necessary\nclinical work and provide the additional information required to address the\nconcerns of the FDA outlined in the CRL and Type A meeting; that our supply\nchain is largely unaffected by implemented and proposed government tariffs and\nwill be reliable and stable in production and global distribution for the near\nterm; our cash requirements, cash funding and cash burn; short-term and longer\nterm liquidity, including access to additional funds if Anaphylm is approved\nby the FDA, and the ability to fund our business operations and key objectives\nin 2026 and beyond, including the launch of Anaphylm, if approved by the FDA;\nour growth and future financial and operating results and financial position,\nincluding with respect to our 2026 financial outlook; and business strategies,\nmarket opportunities, and other statements that are not historical facts. Such\nforward‑looking statements also include statements regarding anticipated\ntimelines, milestones, and guidance relating to regulatory submissions,\nclinical studies, regulatory interactions, and potential approvals, which are\ninherently uncertain and subject to change based on regulatory feedback,\nprotocol alignment, data sufficiency, and other factors outside the\nCompany’s control.\n\nThese forward-looking statements are based on our current expectations and\nbeliefs and are subject to a number of risks and uncertainties that could\ncause actual results to differ materially from those described in the\nforward-looking statements. Such risks and uncertainties include, but are not\nlimited to, risks associated with our development work, including any delays\nor changes to the timing, cost and success of our product development\nactivities and clinical trials and plans for Anaphylm and AQST-108; risk of\ndelays in advancement of the regulatory approval process through the FDA of\nour product candidates Anaphylm, Libervant and AQST-108, or failure to receive\nFDA approval at all of any or all of these product candidates; risk of the\nCompany’s ability to generate sufficient clinical and other human factor\ndata, including with respect to our submission of pharmacokinetic and\npharmacodynamic (PK/PD) comparability data for FDA approval of Anaphylm; risks\nassociated with our ability to address the FDA’s comments on and identified\ndeficiencies in our NDA, including the concerns raised by the FDA in the CRL\nand Type A meeting for Anaphylm, and whether the FDA may request further\ninformation from us (including additional clinical studies), disagree with our\nprotocols, study designs, and findings or otherwise undertake a lengthy review\nof the resubmission of our NDA; challenges regarding the following commercial\nlaunch of Anaphylm, if approved by the FDA; risk of delays in advancement of\nthe regulatory approval process of our product candidates, including Anaphylm\nand Libervant, outside of the U.S., or failure to receive approval at all of\nany or all of these product candidates by such foreign regulatory authorities;\nincluding risks that regulatory authorities outside the United States may\nrequire different, additional, or more extensive clinical, non‑clinical,\nhuman factors, pharmacokinetic, or manufacturing data than anticipated, or may\nnot accept data generated for U.S. regulatory purposes; risk of FDA\ninspections of manufacturing and clinical study sites for any of our product\ncandidates, including Anaphylm, Libervant and AQST-108; risk of government\nshutdowns or actions to reduce government workforces on the ability of the FDA\nto act on a timely basis or at all on the approval of our product candidates,\nincluding Anaphylm, Libervant and AQST-108; risks associated with the success\nof any competing products, including generics; risks and uncertainties\ninherent in commercializing a new product (including technology risks,\nfinancial risks, market risks and implementation risks and regulatory\nlimitations); risk of development of a sales and marketing capability for\ncommercialization of our product candidates, including Anaphylm, Libervant and\nAQST-108, if these product candidates are approved by the FDA; risks\nassociated with the potential impact on the value of the Company of the sale\nor outlicensing of our product candidates, including Anaphylm, Libervant and\nAQST-108; risk of sufficient capital and cash resources, including sufficient\naccess to available debt and equity financing, including under our debt and\nATM facilities, and revenues from operations, to satisfy all of our short-term\nand longer-term liquidity and cash requirements to support our business\noperations, key initiatives and growth strategy, and other cash needs, at the\ntimes and in the amounts needed, and to fund future clinical development and\ncommercial activities for our product candidates, including Anaphylm,\nLibervant and AQST-108, should these product candidates be approved by the FDA\n, including risks that assumptions underlying projected cash runway,\nliquidity, and capital sufficiency may prove incorrect due to changes in\noperating plans, regulatory requirements, timing or scope of clinical\nactivities, market conditions, or the availability, timing, and terms of\nfinancing; risk of the impact of our obligations under the Company's Purchase\nAgreement and the Royalty Rights Agreement with third parties, each of which\nagreements requires the Company to make payments to each counterparty thereof,\nrespectively, of a portion of our revenues, on our ability to contribute to\nthe funding of our operations; risk that our manufacturing capabilities will\nbe sufficient to support demand of our product candidates in the U.S. and\nabroad, including Anaphylm and Libervant, if such product candidates should be\napproved by the FDA and other regulatory authorities, and our licensed\nproducts in the U.S. and abroad; risk of eroding market share for Suboxone®\nas a sunsetting product, which accounts for a substantial part of our current\noperating revenue; risk of default of our debt instruments; risks related to\nthe outsourcing of certain sales, marketing and other operational and staff\nfunctions to third parties; risk of the rate and degree of market acceptance\nin the U.S. and abroad of our product candidates, including Anaphylm,\nLibervant, and AQST-108 should these product candidates be approved by the FDA\nand other regulatory authorities, and for our licensed products in the U.S.\nand abroad; risk associated with the size and growth of our product markets\nand expected related revenues and sales; risk associated with our compliance\nwith all FDA and other governmental and customer requirements for our\nmanufacturing facilities; risks associated with intellectual property rights\nand infringement claims relating to our products; risk that our patent\napplications for our product candidates, including for Anaphylm, will not be\ntimely issued, or issued at all, by the U.S. Patent and Trademark Office or,\nif issued, will be sufficient to provide long-term commercial success of these\nproduct candidates; risk of unexpected patent developments; risk of\nlegislation and regulatory actions and changes in laws or regulations\naffecting our business, including relating to our products and product\ncandidates and product pricing, reimbursement or access therefor; risk of loss\nof significant customers; risks related to claims and legal proceedings\nagainst us including patent infringement, securities, business torts,\ninvestigative, product safety or efficacy and antitrust litigation matters;\nrisk of product recalls and withdrawals; risks related to any disruptions in\nour information technology networks and systems, including the impact of\ncybersecurity attacks; risk of increased cybersecurity attacks and data\naccessibility disruptions, including due to remote working arrangements; risk\nof adverse developments affecting the financial services industry; risks\nrelated to inflation and changing interest rates; risks related to the impact\nof pandemic diseases on our business; risks and uncertainties related to\ngeneral economic, political (including the Ukraine, Israel and Iran wars and\nother acts of war and terrorism), business, industry, regulatory, financial\nand market conditions and other unusual items; risks related to uncertainty\nabout presidential administration initiatives and their impact on our\nbusiness, including imposition of government tariffs and other trade\nrestrictions; and other uncertainties affecting the Company including those\ndescribed in the \"Risk Factors\" section and in other sections included in the\nCompany’s Annual Report on 10-K, Quarterly Reports on Form 10-Q, and Current\nReports on Form 8-K filed with the U.S. Securities and Exchange Commission.\nGiven those uncertainties, you should not place undue reliance on these\nforward-looking statements, which speak only as of the date made. All\nsubsequent forward-looking statements attributable to the Company or any\nperson acting on its behalf are expressly qualified in their entirety by this\ncautionary statement. The Company assumes no obligation to update\nforward-looking statements or outlook or guidance after the date of this press\nrelease whether as a result of new information, future events or otherwise,\nexcept as may be required by applicable law.\n\n           \n\nLibervant(®), PharmFilm(®), Sympazan(®) and the Aquestive logo are\nregistered trademarks of Aquestive Therapeutics, Inc. All other registered\ntrademarks referenced herein are the property of their respective owners.\n\nInvestor inquiries:\nAstr Partners\nBrian Korb\nbrian.korb@astrpartners.com \n\n AQUESTIVE THERAPEUTICS, INC.                                                                                                                                                                                                        \n Condensed Balance Sheets                                                                                                                                                                                                            \n (In thousands, except share and per share amounts)                                                                                                                                                                                  \n (Unaudited)                                                                                                                                                                                                                         \n                                                                                                                                                                                                                                     \n                                                                                                                                                                                 March 31, 2026            December 31, 2025         \n Assets                                                                                                                                                                                                                              \n Current assets:                                                                                                                                                                                                                     \n Cash and cash equivalents                                                                                                                                                       $      110,734            $       121,169           \n Trade and other receivables, net                                                                                                                                                       6,867                      17,763            \n Inventories                                                                                                                                                                            8,066                      6,169             \n Prepaid expenses and other current assets                                                                                                                                              4,516                      4,168             \n Total current assets                                                                                                                                                                   130,183                    149,269           \n Property and equipment, net                                                                                                                                                            3,839                      3,893             \n Right-of-use assets, net                                                                                                                                                               4,468                      4,621             \n Other non-current assets                                                                                                                                                               2,635                      2,642             \n Total assets                                                                                                                                                                    $      141,125            $       160,425           \n                                                                                                                                                                                                                                     \n Liabilities and stockholders’ deficit                                                                                                                                                                                               \n Current liabilities:                                                                                                                                                                                                                \n Accounts payable                                                                                                                                                                $      11,889             $       29,862            \n Accrued expenses                                                                                                                                                                       3,449                      5,029             \n Lease liabilities, current                                                                                                                                                             662                        631               \n Deferred revenue, current                                                                                                                                                              1,092                      1,092             \n Liability related to the sale of future revenue, current                                                                                                                               1,000                      1,000             \n Loans payable, current                                                                                                                                                                 13,661                     9,994             \n Total current liabilities                                                                                                                                                              31,753                     47,608            \n Notes payable, net                                                                                                                                                                     25,099                     27,519            \n Royalty obligations, net                                                                                                                                                               26,914                     25,941            \n Liability related to the sale of future revenue, net                                                                                                                                   62,083                     62,023            \n Lease liabilities                                                                                                                                                                      4,159                      4,337             \n Deferred revenue, net of current portion                                                                                                                                               19,118                     19,390            \n Other non-current liabilities                                                                                                                                                          6,053                      7,269             \n Total liabilities                                                                                                                                                                      175,179                    194,087           \n Contingencies                                                                                                                                                                                                                       \n                                                                                                                                                                                                                                     \n Stockholders’ deficit:                                                                                                                                                                                                              \n Common stock, $0.001 par value. Authorized 250,000,000 shares; 124,284,542 and 122,044,299 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively         124                        122               \n Additional paid-in capital                                                                                                                                                             420,877                    413,214           \n Accumulated deficit                                                                                                                                                                    (455,055  )                (446,998  )       \n Total stockholders’ deficit                                                                                                                                                            (34,054   )                (33,662   )       \n Total liabilities and stockholders’ deficit                                                                                                                                     $      141,125            $       160,425           \n                                                                                                                                                                                                                                     \n\n\n\n AQUESTIVE THERAPEUTICS, INC.                                                                                        \n Condensed Statements of Operations and Comprehensive Loss                                                           \n (In thousands, except share and per share data amounts)                                                             \n (Unaudited)                                                                                                         \n                                                                                                                     \n                                                         Three Months Ended March 31,                                \n                                                                2026                              2025               \n Revenues                                                $      14,446                     $      8,720              \n Costs and expenses:                                                                                                 \n Manufacture and supply                                         3,469                             3,652              \n Research and development                                       4,204                             5,361              \n Selling, general and administrative                            10,977                            19,072             \n Total costs and expenses                                       18,650                            28,085             \n Loss from operations                                           (4,204       )                    (19,365     )      \n Other income/(expenses):                                                                                            \n Interest expense                                               (2,903       )                    (2,782      )      \n Interest expense related to royalty obligations                (973         )                    (1,437      )      \n Interest expense related to the sale of future revenue         (60          )                    (59         )      \n Interest income and other income, net                          83                                713                \n Net loss before income taxes                                   (8,057       )                    (22,930     )      \n Net loss                                                $      (8,057       )             $      (22,930     )      \n Comprehensive loss                                      $      (8,057       )             $      (22,930     )      \n                                                                                                                     \n Loss per share attributable to common stockholders:                                                                 \n Basic and diluted (in dollars per share)                $      (0.07        )             $      (0.24       )      \n Weighted average common shares outstanding:                                                                         \n Basic and diluted (in shares)                                  122,609,995                       95,497,056         \n                                                                                                                     \n\nAQUESTIVE THERAPEUTICS, INC.\nReconciliation of Non-GAAP Adjustments - Net Loss to Non-GAAP Adjusted EBITDA\n(In Thousands)\n(Unaudited)\n\n                                                                    Three Months Ended March 31,                        \n                                                                           2026                         2025            \n GAAP net loss                                                      $      (8,057  )             $      (22,930  )      \n Share-based compensation expense                                          2,318                        1,587           \n Interest expense                                                          2,903                        2,782           \n Interest expense related to royalty obligations                           973                          1,437           \n Interest expense related to the sale of future revenue                    60                           59              \n Interest income and other income, net                                     (83     )                    (713     )      \n Depreciation and Amortization                                             113                          139             \n Total non-GAAP adjustments                                         $      6,284                 $      5,291           \n Non-GAAP adjusted EBITDA                                           $      (1,773  )             $      (17,639  )      \n Excluding Non-GAAP adjusted R&D expenses                                  (3,954  )                    (5,016   )      \n Non-GAAP adjusted EBITDA excluding Non-GAAP adjusted R&D expenses  $      2,181                 $      (12,623  )      \n                                                                                                                        \n\n\n\n AQUESTIVE THERAPEUTICS, INC.                                                                                       \n Reconciliation of Non-GAAP Adjustments - GAAP Expenses to Non-GAAP Adjusted Expenses                               \n (In Thousands, except percentages)                                                                                 \n (Unaudited)                                                                                                        \n                                                                                                                    \n                                                                 Three Months Ended March 31,                       \n                                                                        2026                         2025           \n Total costs and expenses                                        $      18,650                $      28,085         \n Non-GAAP adjustments:                                                                                              \n Share-based compensation expense                                       (2,318  )                    (1,587  )      \n Depreciation and amortization                                          (113    )                    (139    )      \n Non-GAAP adjusted costs and expenses                            $      16,219                $      26,359         \n                                                                                                                    \n                                                                                                                    \n Manufacture and Supply Expenses                                 $      3,469                 $      3,652          \n Gross Margin on total revenue                                          76      %                    58      %      \n Non-GAAP adjustments:                                                                                              \n Share-based compensation expense                                       (69     )                    (100    )      \n Depreciation and amortization                                          (86     )                    (115    )      \n Non-GAAP adjusted manufacture and supply expenses               $      3,314                 $      3,437          \n Non-GAAP Gross Margin on total revenue                                 77      %                    61      %      \n                                                                                                                    \n                                                                                                                    \n Research and Development Expenses                               $      4,204                 $      5,361          \n Non-GAAP adjustments:                                                                                              \n Share-based compensation expense                                       (236    )                    (330    )      \n Depreciation and amortization                                          (14     )                    (15     )      \n Non-GAAP adjusted research and development expenses             $      3,954                 $      5,016          \n                                                                                                                    \n                                                                                                                    \n Selling, General and Administrative Expenses                    $      10,977                $      19,072         \n Non-GAAP adjustments:                                                                                              \n Share-based compensation expense                                       (2,013  )                    (1,157  )      \n Depreciation and amortization                                          (13     )                    (9      )      \n Non-GAAP adjusted selling, general and administrative expenses  $      8,951                 $      17,906         \n\n\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/e0b65f93-9565-43d7-a6ff-88b8cbd6adea)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-05-13T20:01:01.439444969Z","server_sent_at_ms":1778702461439},"received_at":"2026-05-13T20:01:01.513Z","source_url":null},"analysis":null,"durationMs":null,"modelName":null}}