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Talphera (TLPH) investor relations material
Talphera Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary12 Nov, 2025
Executive summary
NEPHRO study enrollment accelerated after protocol changes, but delays in activating new high-volume sites have shifted expected completion to the first half of 2026.
Closed $17 million first tranche of a private placement led by CorMedix, with a second $12 million tranche contingent on study milestones, and CorMedix gaining board representation and exclusive acquisition negotiation rights.
Cash and investments at September 30, 2025, were $21.3 million, expected to fund operations through potential Niyad PMA approval in late 2026, assuming future financing tranches.
Niyad, if approved, would be the only FDA-approved regional anticoagulant for CRRT, addressing significant unmet needs, and has received FDA Breakthrough Device Designation.
Net loss for Q3 2025 was $4.4 million, with improved year-over-year results and reduced operating expenses.
Financial highlights
Cash, cash equivalents, and investments totaled $21.3 million as of September 30, 2025, up from $8.9 million at year-end 2024, due to private placements.
Q3 2025 cash operating expenses were $3.4 million, down from $3.7 million in Q3 2024; excluding stock-based compensation, $3.3 million vs. $3.5 million.
Net loss per share was $0.11 for Q3 2025, compared to $0.13 for Q3 2024.
Research and development expenses decreased 12% year-over-year for Q3, mainly due to lower headcount and Niyad-related costs.
Revenue was negligible for both Q3 and the nine-month period.
Outlook and guidance
Sufficient capital is expected through anticipated Niyad PMA approval in late 2026, supported by current cash and conditional financing, but management expects to need additional capital within the next twelve months.
NEPHRO study completion is now anticipated in the first half of 2026 due to site activation delays, with further changes to study eligibility criteria submitted to the FDA to accelerate enrollment.
Cash operating expense guidance for 2025 reduced to $14–$15 million from $16–$17 million, with the difference expected in H1 2026.
Plans to continue development of nafamostat product candidates and pursue regulatory approval for Niyad.
CorMedix acquisition right: What are the terms?
What drives NEPHRO study enrollment acceleration?
Why did Q3 2025 net loss increase year-over-year?
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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.
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