Talphera — Third Quarter 2026 Earnings Summary

Financial Performance:

• Revenue for the three months ended September 30, 2026, was $0, compared to $1,000 in the same period in 2025.
• Combined Research and Development (R&D) and Selling, General, and Administrative (SG&A) expenses totaled $4.1 million for Q3 2026, an increase from $3.4 million in Q3 2025.
• Excluding non-cash stock-based compensation, combined R&D and SG&A expenses were $3.8 million for Q3 2026 versus $3.3 million for Q3 2025.
• Net loss attributable to common shareholders was $4.0 million ($0.05 per share) for Q3 2026, compared to a net loss of $4.4 million ($0.11 per share) for Q3 2025.
• Cash and investments balance was $14.2 million as of September 30, 2026, down from $20.4 million as of December 31, 2025.
• Total operating costs and expenses for the nine months ended September 30, 2026, were $12.0 million, compared to $10.1 million for the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $10.9 million ($0.15 per share), compared to $10.5 million ($0.31 per share) in 2025.

Guidance and Future Outlook:

• Management aims to complete the NEPHRO CRRT study by the end of 2026.
• Updated market research raises the estimated peak sales for nafamostat in CRRT to more than $200 million.
• Talphera plans to file a Form S-3 Shelf Registration Statement to replace its existing Form S-3, which expires on November 30, 2026.

Business Segments and Product Lines:

• The company submitted a briefing document to the FDA requesting feedback on closing the NEPHRO CRRT study enrollment as of December 31, 2026, even if fewer than the targeted 70 patients are enrolled.
• Enrollment in the NEPHRO CRRT study has exceeded 75% of the planned 70 patients, providing over 80% statistical power for the primary endpoint.
• Enrollment has slowed due to fewer qualifying patients at clinical sites, a challenge noted in other recent CRRT studies.
• The NEPHRO CRRT study is designed to evaluate Niyad (nafamostat) versus placebo in 70 adult patients undergoing renal replacement therapy who cannot tolerate heparin or are at risk for bleeding.
• Niyad has received Breakthrough Device Designation status from the FDA.
• An ICD-10 procedural code (XY0YX37) has been issued for the extracorporeal introduction of nafamostat.
• Increased R&D expenses in Q3 2026 were driven by Niyad development project activities.
• Increased SG&A expenses in Q3 2026 were related to pre-launch commercial preparation activities.

Market and Competitive Landscape:

• Updated qualitative and quantitative market research supports the potential adoption of nafamostat in CRRT compared to currently used products.
• The company notes that some sponsors of other recent CRRT studies have closed enrollment early and subsequently received regulatory approval.

Risks and Challenges:

• Clinical studies may not be fully enrolled or completed, or may not confirm safety, efficacy, or other potential developmental product characteristics.
• Product candidates may not be beneficial to patients or healthcare providers or may not be successfully commercialized.
• The company faces risks related to obtaining regulatory approvals for its developmental product candidates.
• Risks exist regarding the ability to implement development plans, commercial launch plans, and forecasts.
• Liquidity risks include the ability to maintain capital resources sufficient to conduct clinical studies.

Management Commentary and Tone:

• CEO Vince Angotti stated that nafamostat has the potential to address an important unmet need as a regional anticoagulant for critically ill patients undergoing CRRT.
• Management expressed confidence that the current enrollment is sufficient to support a PMA filing due to the study's statistical power exceeding 80%.
• The tone regarding enrollment challenges was pragmatic, acknowledging the difficulty of enrolling critically ill patients while citing precedents of early closure leading to approval.

Other Key Points:

• The NEPHRO CRRT study is a prospective, double-blinded trial conducted at up to 14 U.S. hospital intensive care units.
• The primary endpoint is mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours.
• The study is powered over 90% for the primary endpoint with 70 patients.
• LTX-608, a proprietary nafamostat formulation for direct IV infusion, is being investigated for potential treatment of acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC), acute pancreatitis, or as an anti-viral treatment.
• The company held a conference call and webcast on November 12, 2026, to discuss results and provide a business update.