Aquestive Reports $31.9M Q4 Loss, FY Loss Widens, Targets Q3 2026 Anaphylm Resubmission
Aquestive posted a Q4 loss of $31.9M (26 cents per share) on $13M revenue, vs. estimates of a 13-cent loss and $13.4M revenue; FY loss widened to $83.8M on $44.5M revenue. Aquestive plans to resubmit the Anaphylm sublingual epinephrine NDA in Q3 2026, targets $70M cash, advances AQST-108 alopecia trials.
1. Q4 Financial Performance
Aquestive posted a net loss of $31.9 million, or 26 cents per share, on $13 million revenue in the fourth quarter, missing consensus estimates of a 13-cent loss and $13.4 million revenue. For full-year 2025, the loss widened to $83.8 million, with revenue totaling $44.5 million.
2. Anaphylm Regulatory and Cash Guidance
Aquestive received a Complete Response Letter for its Anaphylm sublingual epinephrine NDA citing human factors validation and a pharmacokinetics study requirement, with no chemistry, manufacturing or controls deficiencies. The company has requested a Type A meeting, plans to resubmit in Q3 2026 and targets $70 million in cash at year-end to support launch preparations.
3. AQST-108 Alopecia Areata Program
AQST-108, a topical epinephrine gel candidate for alopecia areata, completed dosing in its second Phase 1 clinical trial, with data expected in Q2 2026. Designed to act locally with minimal systemic exposure, the therapy could capture share in a market exceeding $1 billion for severe cases.