Aquestive Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update

Aquestive Reaffirms Anaphylm NDA Resubmission, Reports Strong Q1 2026 Results

Aquestive Therapeutics reported its first quarter 2026 financial results, demonstrating increased revenue and a significantly reduced net loss. The company reaffirmed its target to resubmit the Anaphylm™ (dibutepinephrine) sublingual film New Drug Application (NDA) to the FDA in Q3 2026, following a successful Type A meeting where study designs were aligned. Additionally, Aquestive completed a Phase 1 study for AQST-108 (epinephrine) topical gel, which showed no safety issues and identified a biomarker signal. Financially, the company strengthened its balance sheet by entering into a new $150 million debt facility with Oaktree Capital Management, extending its cash runway and anticipating $45 million in principal payment savings.

• Aquestive Therapeutics successfully completed a Type A meeting with the FDA, achieving alignment on the necessary human factors validation and pharmacokinetics (PK) studies required to address deficiencies from the Complete Response Letter for Anaphylm. The company remains on track to resubmit the Anaphylm NDA in the third quarter of 2026 and plans to request an accelerated review. Global regulatory efforts are also progressing, with submissions planned for Canada, the European Union, and the United Kingdom using existing clinical data.
• The Phase 1 clinical trial for AQST-108 (epinephrine) topical gel, evaluated for potential dermatologic indications, was completed without any drug-related adverse events or signs of systemic absorption. Importantly, the study identified a biomarker signal through the suppression of thymic stromal lymphopoietin (TSLP), a pathway involving JAK1 and JAK2 activation. This finding supports further exploration of AQST-108 for conditions like alopecia areata and atopic dermatitis, with an atopic dermatitis study planned.
• Aquestive significantly improved its financial position by securing a new $150 million debt facility with Oaktree Capital Management, which is expected to save $45 million in principal payments over the next three years and extends the company's cash runway until 2031. For the first quarter of 2026, total revenues increased by 66% to $14.4 million compared to $8.7 million in Q1 2025, while the net loss decreased substantially to $8.1 million from $22.9 million in the prior year period.

Addressing Key Challenges in Anaphylaxis Treatment

Current anaphylaxis treatment approaches face significant clinical and systemic challenges that impact patient outcomes across different care settings. These limitations range from diagnostic complexity to drug interactions and inadequate healthcare infrastructure.

• Delayed recognition and administration of epinephrine remains a critical factor associated with fatality from food-induced anaphylaxis, with diagnostic complexity particularly evident in perioperative settings where anaphylaxis presentation is often masked by anesthesia

• Drug interaction complications create treatment challenges, as concurrent use of β-blockers can impair epinephrine's blood pressure response via α1- and β1-receptor stimulation, while patients on antihypertensive medications present additional complexities when managing anaphylactic shock

• Limited evidence for refractory cases represents a significant gap, with lack of robust data for managing severe cases that don't respond to standard intramuscular epinephrine, necessitating potential intravenous administration but requiring further accumulation of case reports and observational studies

• Inadequate school-based emergency preparedness poses risks for pediatric patients, with insufficient school nurse coverage, inadequately trained staff, and lack of standardized approaches to food allergy emergency management contributing to increased anaphylaxis risk in educational settings

• Unpredictable clinical presentation continues to challenge clinicians despite global improvements in safety protocols, as anaphylaxis can affect any individual regardless of known allergic history, requiring all healthcare providers and vaccination sites to maintain readiness for recognition and treatment of severe allergic reactions

Anaphylm's Position in the Anaphylaxis Treatment Landscape

The current evidence base for anaphylaxis treatment remains limited, with most therapeutic recommendations based on expert consensus and case reports rather than robust randomized controlled trials. Epinephrine continues as the established first-line treatment and represents the only medication with documented efficacy in preventing hospitalizations, hypoxic sequelae, and fatalities. However, recent systematic reviews have confirmed the lack of high-grade evidence supporting the use of antihistamines and corticosteroids in anaphylaxis, despite their continued frequent use in clinical practice. β2-adrenergic agonists and glucagon serve as second-line treatments, while glucocorticoids and antihistamines are relegated to third-line therapy.

Several investigational therapies are emerging as alternatives for refractory cases and preventive treatment. Methylene blue has been proposed by the Joint Taskforce on Practice Parameters as an alternative treatment for anaphylaxis with hypotension that is unresponsive to classical therapy, functioning as a competitive inhibitor of guanylate cyclase that interferes with nitric oxide's vasodilatory actions. A notable 2013 case report demonstrated immediate symptom resolution in a patient with severe epinephrine-refractory anaphylaxis following methylene blue infusion, suggesting potential efficacy even in normotensive patients with refractory disease. Additionally, alternative routes of epinephrine administration are under investigation to address mechanical issues and injection-related anxiety.

Omalizumab represents the most significant advancement in preventive anaphylaxis treatment, recently approved as the first anti-IgE therapy for multiple food allergies. This subcutaneous monoclonal antibody, administered every 2-4 weeks based on patient weight and serum IgE levels, works by binding and neutralizing serum IgE antibodies to increase the threshold dose for allergic reactions. The landmark OUtMATCH trial demonstrated significant increases in tolerance thresholds across multiple food allergens, including peanuts, cashew, milk, egg, walnut, wheat, and hazelnut. Compared to oral immunotherapy, the previous standard preventive approach, omalizumab offers reduced treatment burden and appears to facilitate faster desensitization with fewer adverse reactions when used in combination protocols. However, questions remain regarding optimal patient selection, comparative effectiveness, and long-term outcomes, with ongoing trials expected to provide additional real-world efficacy data.

Paving the Way for Needle-Free Anaphylaxis Care

The landscape of anaphylaxis management is poised for a significant evolution, driven by the persistent challenges associated with current emergency treatments. While epinephrine remains the undisputed first-line therapy for this life-threatening condition, its delivery via auto-injectors often encounters barriers such as injection fear, undercarriage, and even misuse, leading to critical delays in administration. These factors contribute to the documented underuse of epinephrine, despite clear guidelines emphasizing its life-saving importance.

Against this backdrop, the recent advancements in novel epinephrine delivery methods offer a beacon of hope. The progress of a sublingual film, Anaphylm™, towards an NDA resubmission, following successful alignment with regulatory bodies on study designs, marks a crucial step. This needle-free approach could directly address the psychological and practical hurdles many patients and caregivers face with injections. Similarly, the promising Phase 1 results for a topical epinephrine gel, AQST-108, further underscore the potential for less invasive and more convenient options. These innovations are not merely incremental improvements; they represent a strategic effort to expand the accessibility and effectiveness of emergency anaphylaxis treatment, potentially improving patient adherence and outcomes by offering alternatives that fit diverse patient needs.

However, the path forward is not without its complexities. Regulatory approval, while seemingly closer, still requires rigorous demonstration of efficacy and safety for these novel routes, especially given the critical nature of anaphylaxis. Furthermore, even with needle-free options, ensuring widespread adoption and correct use will necessitate comprehensive education for both patients and healthcare providers, a challenge that has historically plagued auto-injector use. The established market for auto-injectors also means that new entrants must clearly articulate their value proposition to shift prescribing patterns. Nevertheless, the financial strengthening of companies pursuing these innovations provides the necessary runway to navigate these challenges, signaling a determined push towards a future where prompt, effective, and patient-friendly anaphylaxis care is more universally achievable.