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Edge16 Oct 2026
Winner, Winner: The Chicken McNugget Story
How a 1940s breeding contest, a Cornell food scientist, and a hedge by Ray Dalio helped McDonald's turn the Chicken McNugget into a fast-food icon.
Talphera
Talphera (TLPH) investor relations material
Talphera Q3 2026 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2026 earnings summary12 Nov, 2026
Executive summary
NEPHRO-CRRT enrollment exceeded 75% of its 70-patient target, with estimated power above 80% for the primary endpoint; FDA is reviewing a request to close enrollment by Dec. 31, 2026.
Updated research estimates peak annual U.S. Niyad sales for CRRT at more than $200 million, contingent on approval.
Financial highlights
Q3 revenue was $1K versus $28K in Q3 2025; operating expenses were $4.136M versus $3.423M, and operating loss was $4.1M versus $3.4M.
Q3 net loss was $4.018M versus $4.436M; nine-month net loss was $10.886M versus $10.518M.
Q3 R&D and SG&A excluding non-cash stock compensation were $3.844M versus $3.271M; nine-month totals were $11.259M versus $9.545M.
Cash, cash equivalents and short-term investments were $14.157M at Sept. 30, 2026, versus $20.381M at Dec. 31, 2025.
Nine-month cash used in operations was $10.4M versus $8.9M.
Outlook and guidance
The FDA briefing document seeks agreement to close enrollment as of Dec. 31, 2026, potentially below 70 patients; feedback is expected before year-end.
Top-line data are expected 4–6 weeks after enrollment closes; potential Niyad PMA approval is expected in 2027.
If FDA does not agree to early closure, enrollment would continue toward 70 patients, with internal forecasts placing completion in Q1 2027.
A possible FDA middle path could allow PMA filing while the study remains open to collect supplemental data.
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Latest events from Talphera
- A $150 million shelf backs Niyad-focused development amid financing and clinical risks.TLPH
Registration filing - Pivotal nafamostat study nears completion, targeting U.S. approval and strong market adoption.TLPHH.C. Wainwright 28th Annual Global Investment Conference
- Q2 net loss was $4.3M as nafamostat gains guideline support and CRRT market expands 21%.TLPHQ2 2026
- All proposals, including director elections and plan amendments, were approved without shareholder questions.TLPHAGM 2026
- NEPHRO CRRT study enrollment surpassed 50%, Q1 net loss was $2.6M, cash at $21.1M.TLPHQ1 2026
- Board recommends approval of all proposals, including director elections and plan amendments.TLPHProxy filing
- Annual meeting seeks approval for directors, auditor, compensation, and equity plans.TLPHProxy filing
- Nephro CRRT study hits 50% enrollment; $20.4M cash at year-end 2025; Niyad seen as promising.TLPHQ4 2025 & Investor Day
- Q2 net loss narrowed to $3.8M, cash rose to $14M, and NEPHRO study enrollment accelerated.TLPHQ2 2024
Next Talphera earnings date
Q4 202624 Mar, 2027
Talphera
Next Talphera earnings date
Q4 202624 Mar, 2027
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Frequently asked questions
Talphera Inc, a specialty pharmaceutical company, focuses on the development and commercialization of therapies for the treatment of acute pain. The Company's lead product candidate is DSUVIA™ (sufentanil sublingual tablet, 30 mcg) which has completed Phase 3 trials. The Company believes that DSUVIA is a potential first-in-class non-invasive treatment option that can deliver rapid relief to patients suffering from moderate to severe acute pain.