v3.26.3
Segment Reporting
9 Months Ended
Sep. 30, 2026
Segment Reporting [Abstract]  
Segment Reporting Segment Reporting
Operating segments are defined as components of an entity for which separate discrete financial information is available for evaluation by the CODM in deciding how to allocate resources and in assessing performance. For the nine months ended September 30, 2026 and 2025, the Company has identified one operating and reportable segment. The Company defines its operating segment based on internally reported financial information that is regularly reviewed by the CODM to analyze financial performance, make decisions, and allocate resources. The Company's CEO is the CODM. The Company manages its operations as a single segment for purposes of assessing performance and making operating decisions. This segment encompasses the development and advancement of a product pipeline for the treatment of severe allergic reactions, including anaphylaxis, and the AdrenaVerse epinephrine prodrug pipeline platform. Additionally, the Company served as the exclusive manufacturer for its proprietary product, Libervant, while it had U.S. market access, and four commercialized products.
The CODM reviews the segment's profit or loss based on net loss reported on the Condensed Statements of Operations and Comprehensive Loss. The CODM also considers forecast-to-actual variances on a monthly basis for expenses deemed significant. Furthermore, the CODM reviews the segment's assets based on total assets reported on the Condensed Balance Sheets. All long-lived assets are held in the United States. While the Company generated $7,557 and $12,807 in revenues for the three months ended September 30, 2026 and 2025, respectively, and $35,822 and $31,530 for the nine months ended September 30, 2026 and 2025, respectively, management expects the Company to continue to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through all stages of development and clinical trials, ultimately seeking regulatory approval and commencing commercialization activities for Anaphylm, if approved by the FDA. The CODM uses cash forecast models to guide investment decisions and assess entity-wide operating results and performance. Net loss is used to monitor budget and rolling forecasts versus actual results. The CODM views specific categories within R&D expenses, selling expenses, and general and administrative expenses as significant due to their direct correlation with cash burn and profitability.
The following table reconciles reported revenues to net loss under the significant expense principle for the three and nine months ended September 30, 2026 and 2025:
Three Months Ended September 30,Nine Months Ended
September 30,
2026202520262025
Revenues$7,557 $12,807 $35,822 $31,530 
Costs and expenses:
Total Manufacture and Supply Expenses
3,606 4,506 11,092 12,719 
R&D Project expenses:
Anaphylm project expenses
1,179 912 3,319 4,604 
AQST-108 project expenses294 (131)1,004 254 
R&D other expenses:
Personnel costs1
2,218 3,001 6,641 7,351 
Other2
560 748 1,453 1,787 
Total Research and Development Expenses
4,251 4,530 12,417 13,996 
Selling expenses:
Personnel costs3
1,740 805 5,114 2,108 
Other4
2,006 3,110 2,726 8,283 
Total Selling expenses
3,746 3,915 7,840 10,391 
General & Administrative expenses:
Personnel costs5
5,405 5,017 17,516 15,025 
Other6
5,018 6,318 13,853 21,611 
Total General and Administrative Expenses
10,423 11,335 31,369 36,636 
Total Selling, General and Administrative Expenses
14,169 15,250 39,209 47,027 
Total costs and expenses22,026 24,286 62,718 73,742 
Loss from operations(14,469)(11,479)(26,896)(42,212)
Other income/(expenses), net
(2,027)(3,967)(20,521)(9,712)
Net loss before income taxes(16,496)(15,446)(47,417)(51,924)
Net loss$(16,496)$(15,446)$(47,417)$(51,924)
Comprehensive loss$(16,496)$(15,446)$(47,417)$(51,924)
1 - R&D Personnel costs include payroll expenses, share-based compensation expenses and severance
2 - Other R&D expenses include preclinical, consulting, maintenance, and testing fees
3 - Selling Personnel costs include payroll expenses, share-based compensation expenses and severance
4 - Other Selling expenses include commercialization and other related expenses
5 - G&A Personnel costs include payroll expenses, share-based compensation expenses and severance
6 - Other General and Administrative expenses include legal/patent fees, insurance fees, IT expenses, investor relations expenses, regulatory fees, facility and other costs