Talphera (TLPH) investor relations material

Executive summary

• NEPHRO-CRRT study enrollment reached 75%, with completion expected by year-end 2026; all clinical sites are now activated and led by nephrologists in ICUs.

• KDIGO 2026 guideline draft now references nafamostat as an acceptable regional anticoagulant, marking its first inclusion and supporting future commercialization if approved.

• Updated market research estimates 200,000 annual CRRT procedures in the U.S. by 2027, a 21% increase from prior estimates, indicating a larger market opportunity.

• Principal investigators report straightforward study procedures and high enthusiasm for nafamostat, with feedback suggesting it could become a first-line therapy if approved.

• Regained Nasdaq minimum bid price compliance in July 2026.

Financial highlights

• Cash and investments totaled $17.1 million as of June 30, 2026, down from $20.4 million at year-end 2025.

• Cash operating expenses for Q2 2026 were $3.9 million, up from $3.7 million in Q2 2025, mainly due to higher NIYAD development and market research expenses.

• Net loss for Q2 2026 was $4.3 million, or $0.06 per share, compared to $3.5 million, or $0.10 per share, in Q2 2025.

• Operating cash outflow was $7.3 million for the first half of 2026.

• Accumulated deficit reached $478.4 million as of June 30, 2026.

Outlook and guidance

• Cash and two remaining conditional financing tranches totaling $16 million are expected to fund operations through a potential NIYAD PMA approval in 2027.

• PMA submission for nafamostat is planned for the first half of 2027, with launch activities to begin upon submission.

• Management expects to need additional capital to fund operations prior to the 12-month anniversary of the filing date, raising substantial doubt about the ability to continue as a going concern.

• Plans to raise capital through equity, debt, or strategic transactions, but success is not assured.

• Ongoing focus on completing Niyad clinical development and regulatory submissions.