Regulatory Progress Toward Anaphylm Resubmission
Completed a Type A face-to-face meeting with the FDA, completed a teleconference with the U.K. MHRA, submitted a pediatric investigational plan to the EMA, and submitted the human factors protocol to the FDA. Company guides to availability of human factors data and potentially PK data by the August earnings call and currently expects a Q3 2026 NDA resubmission (company expects a Type 2 submission with a 6-month review, while pursuing expedited review).
Significant Improvement in Q1 Financial Performance
Total revenues rose to $14.4M in Q1 2026 from $8.7M in Q1 2025, an increase of ~66%. License & royalty revenue increased to $5.4M from $0.8M; manufacturing & supply revenue rose to $8.8M from $7.2M (~+22%). Net loss narrowed to $8.1M ($0.07/share) vs $22.9M ($0.24/share) a year ago (~64.6% reduction). Non-GAAP adjusted EBITDA loss improved to -$1.7M vs -$17.6M in Q1 2025 (large sequential improvement).
Strengthened Liquidity and Financing Flexibility
Closed a $150M debt facility with Oaktree: Tranche A $55M (refinance), Tranche B $20M (available upon FDA approval), Tranche C $25M (sales milestone), Tranche D $50M (mutual consent). Refinancing lowers interest rate and extends interest-only period, saving ~$45M in principal payments over the next 3 years. RTW strategic funding agreement extended to June 30, 2027. Company projects >$150M in cash at launch when combining existing cash, RTW, and financing sources; ended Q1 with ~$110M in cash and cash equivalents.
AQST-108 Phase I Safety and Encouraging Biomarker Signal
Completed Phase I safety study for AQST-108 in men with androgenic alopecia: no drug-related adverse events observed and no appreciable systemic absorption of prodrug or epinephrine. Directional biomarker signal observed (TSLP impacted in subjects with alopecia vs placebo), suggestive of potential broad topical immunomodulatory activity and optionality across dermatologic indications (directional, not statistically powered).
Commercial Preparation and Medical Affairs Momentum
Ongoing commercial preparations for Anaphylm: planning a 75-person U.S. sales force, strong medical affairs presence, and best-in-class hub/patient support. High engagement plan includes attendance at >40 conferences and submission of >20 publications in 2026. Market research shows HCP awareness of product rising from ~33% to ~66%.
Disciplined Expense Management
Q1 2026 R&D expenses decreased to $4.2M from $5.4M (down ~22%) driven by lower clinical trial costs for Anaphylm; SG&A decreased to $11.0M from $19.1M (down ~42%), largely due to the prior-year PDUFA fee and lower legal and commercial spend, contributing to improved net loss and EBITDA results.