Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Corporate Update (February 2026)
11 slides from Aquestive Therapeutics's corporate update, Feb 2, 2026
Slide 1: Anaphylm Sublingual Film Complete Response Letter Supplemental Material
Advancing medicines. Solving problems. Improving lives. September 2024 Advancing medicines. Solving problems. Improving lives. Advancing medicines. Solving problems. Improving lives. 1 Anaphylm (dibutepinephrine) Sublingual Film Complete Response Letter Supplemental Material February 2, 2026
Slide 2: Forward-looking statements disclaimer
© 2026 Aquestive Therapeutics, Inc. 2 ® This presentation has been prepared by Aquestive Therapeutics, Inc . (“Aquestive”, the “Company”, “our” or “us”) and contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “antic
Slide 3: Key takeaways from the FDA's Complete Response Letter (CRL)
3 In the following slides, we provide exact language in the comments contained in the CRL and Aquestive’s viewpoint. Of note: • Deficiencies limited to packaging and administration • Company believes it can rapidly resolve deficiencies and expects to resubmit as early as Q3 2026, assuming completion
Slide 4: CRL Comments and Aquestive Viewpoint
4 CRL Comments and Aquestive Viewpoint • 1 participant (pediatric) was unable to open the (current child resistant) pouch (n=166 participants) • The median time to open the 1st dose pouch was 17 seconds, 2nd dose was 8 seconds; this compares favorably to epinephrine medical device data • There were
Slide 5: Conduct the analysis as requested by the FDA
5 CRL Comments and Aquestive Viewpoint (continued) Aquestive will conduct the analysis as requested by the FDA An alternate opening mechanism is available, has been successfully tested in a human factors formative study, and will be included in the requested human factors validation study
Slide 6: Incorporate the FDA's proposed labeling changes
6 CRL Comments and Aquestive Viewpoint (continued) Aquestive will incorporate the FDA’s proposed labeling changes
Slide 7: Conduct another human factors validation study, as requested
7 CRL Comments and Aquestive Viewpoint (continued) Aquestive will conduct another human factors validation study, as requested Aquestive will continue to provide information on potential tolerability issues However, we note: • In our pivotal clinical data set in the NDA (n=137), tolerability was cit
Slide 8: Discuss with clinical pharmacology team at Type A meeting
8 CRL Comments and Aquestive Viewpoint (continued) Aquestive will discuss with the clinical pharmacology team at the Type A meeting and will conduct the study as requested
Slide 9: CRL Comments and Aquestive Viewpoint (continued)
9 CRL Comments and Aquestive Viewpoint (continued) Aquestive is assessing the potential label impact and if additional clinical data generation is warranted Language matches boilerplate language provided to nasal spray manufacturer in response to auto-injector manufacturer submitted citizen petition
Slide 10: Planned Anaphylm Key Milestones
10 Planned Anaphylm Key Milestones Q1 2026 Type A Meeting with FDA Q2 2026 Q3 2026 Q4 2026 Q1 2027 Human Factors Validation Study NDA Resubmitted* Ex-US filings (Canada, Europe) Clinical PK Study** *Typical FDA response time is six (6) months; Aquestive intends to request expedited review of the NDA
Slide 11: Thank You
<< Aquestive’ Thank You
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