Talphera (TLPH) investor relations material

Executive summary

• Achieved over 50% enrollment in the NEPHRO CRRT study for nafamostat, with completion expected in 2026 and PMA filing planned for 2027.

• Protocol changes, new site activations, and addition of high-volume CRRT sites have accelerated study progress, maximizing the 14-site FDA allowance.

• All resources are focused on Niyad development, with other candidates under evaluation for discontinuation.

• Strong engagement and positive feedback from principal investigators and site staff regarding the study protocol and nafamostat's pharmacology.

• Clinical data presented at a major nephrology conference and investor event highlighted unmet needs in CRRT anticoagulation.

Financial highlights

• Cash and investments totaled $21.1 million as of March 31, 2026.

• Closed a $4.1 million financing tranche in Q1 2026; two conditional tranches totaling $16 million remain.

• Q1 2026 net loss was $2.6 million ($0.04 per share), with combined R&D and SG&A expenses of $3.9 million, up from $2.9 million in Q1 2025.

• Non-GAAP operating expenses (excluding stock-based compensation) were $3.7 million in Q1 2026 versus $2.7 million in Q1 2025.

• Gain on change in fair value of warrant liability was $1.2 million in Q1 2026.

Outlook and guidance

• Confident in completing NEPHRO study enrollment and announcing top-line data in the second half of 2026.

• Sufficient capital expected to last through potential Niyad PMA approval in 2027, contingent on closing remaining financing tranches; additional capital may be needed before the 12-month anniversary of the filing date.

• No further enrollment updates planned until full enrollment; top-line data expected within a month after last patient out.

• Ongoing focus on completing the Niyad NEPHRO CRRT trial and preparing for regulatory submissions.