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Talphera (TLPH) investor relations material
Talphera Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q2 2025 earnings summary14 Aug, 2025
Executive summary
Accelerated enrollment in the NEPHRO study, with 15 patients enrolled and completion targeted by year-end 2025; protocol changes reduced study size to 70 patients and broadened inclusion criteria in agreement with the FDA.
Shifted focus to medical ICUs and nephrologist principal investigators, resulting in over 90% of recent enrollments from new target profile sites; 13 total sites expected by end of Q3 2025.
Niyad, the lead product candidate for CRRT anticoagulation, is in a registrational trial with FDA Breakthrough Device Designation and an ICD-10 procedural code.
Compassionate use IDE for nafamostat is progressing, addressing unmet needs in patients contraindicated for heparin or citrate.
Substantial doubt exists regarding the ability to continue as a going concern without additional capital; management is actively seeking further funding.
Financial highlights
Q2 2025 cash operating expenses were $3.7M, down from $4.3M in Q2 2024, mainly due to lower personnel and G&A costs; excluding stock-based compensation, $3.5M vs. $4.0M.
Net loss for Q2 2025 was $3.5M, improved from $3.8M in Q2 2024; net loss per share was $0.10 vs. $0.15.
Cash and cash equivalents totaled $6.8M as of June 30, 2025, down from $8.9M at year-end 2024.
Research and development expenses decreased 21% to $1.5M for Q2 2025; SG&A expenses fell 7% to $2.2M.
Accumulated deficit reached $463.3M as of June 30, 2025.
Outlook and guidance
Confident in completing the NEPHRO study by end of 2025, with all target profile sites expected to be enrolling by end of Q3.
Cash operating expense guidance for 2025 is $16M–$17M, reduced from $17M–$19M previously.
Additional capital is expected to be needed within twelve months to fund planned operations; options include equity, debt, or strategic transactions.
Anticipate operating expenses to increase in the second half of 2025 due to higher enrollment activity.
Second and third tranches of the 2025 Private Placement could provide up to $9.8M in additional gross proceeds, contingent on clinical milestones.
Explain the compassionate use IDE rationale.
Detail the new site vetting process.
How will citrate/heparin shortages affect Niyad?
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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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