Talphera, Inc. (TLPH) Earnings

Management highlights

- Clinical Trial Progress * The registrational NEFRO CRRT trial for Nefamostat, an anticoagulant for continuous renal replacement therapy (CRRT), has activated all final clinical sites and reached 75% patient enrollment. Management remains on track to complete full enrollment by the end of 2026. * All trial sites now have nephrologists as principal investigators, recruiting patients primarily from medical ICUs. Protocol modifications approved by the FDA have kept the trial on schedule. * The independent Data Safety Monitoring Board completed its first review a few months prior to the call and identified no patient risks or unexpected findings, recommending the trial continue without changes. - Regulatory and Guideline Updates * The 2026 KDIGO (Kidney Disease Improving Global Outcomes) Clinical Practice Guideline for Acute Kidney Injury, which closed its public comment period in May 2026, is pending final publication. The draft guideline lists Nefamostat as an acceptable regional anticoagulant for CRRT, marking the first time Nefamostat has received a KDIGO recommendation, a change from prior guidance. * Currently, the only regional anticoagulant used for CRRT in the U.S. is citrate, which is not FDA-approved for this use, is complex to administer, and has contraindications limiting its use. Nefamostat is already the first-line, most widely used CRRT anticoagulant in Japan (used in ~80% of cases) and South Korea, with decades of real-world clinical experience. - Market Opportunity * Updated primary and secondary market research revises the estimated annual U.S. CRRT procedures upward by 21%, from 165,000 to 200,000 by the projected 2027 launch date. Procedure volume is expected to continue growing annually. * Nefamostat addresses unmet clinical need related to the limitations of the current standard-of-care anticoagulants (systemic heparin and regional citrate), giving the drug potential to capture meaningful market share if approved. - Financial Status * Cash on hand as of Q2 end 2026, plus the $16 million in available conditional financing, is sufficient to fund operations through the expected 2027 PMA (Premarket Approval) for Nefamostat.

Guidance

- Enrollment in the NEFRO CRRT registrational trial is expected to be completed by the end of 2026, with top-line data readout available 4-5 weeks after enrollment closes. - PMA submission to the FDA is expected to occur in the first half of 2027, approximately 3 months after top-line data release. - PMA approval is projected for mid-2027, with management targeting an immediate launch upon approval, with no planned delay between approval and commercial launch. - Pre-launch activities, including hiring of initial commercial and medical education staff, will begin after PMA submission in 2027.

Segment performance

Telferra is a clinical-stage biopharmaceutical company with only one core product candidate in development, Nefamostat. No separate product or business segment financial performance is reported in the transcript. Total cash operating expenses (combined R&D and SG&A) for Q2 2026 were $3.9 million, compared to $3.7 million in Q2 2025. Excluding non-cash stock-based compensation, cash operating expenses were $3.7 million in Q2 2026, compared to $3.5 million in Q2 2025. Cash balance as of June 30, 2026 was $17.1 million. Two conditional financing tranches totaling approximately $16 million in additional capital remain available if pre-specified conditions are met.

Risks & headwinds

- All forward-looking statements related to trial completion, regulatory approval, and commercial launch are subject to inherent risks and uncertainties, as disclosed in Telferra's SEC filings. The actual timing of outcomes may differ from management projections. - Nefamostat has not yet received FDA approval for use in the U.S. The success of the clinical trial and regulatory review is not guaranteed. - Commercial success of Nefamostat depends on physician and institutional adoption, which varies across U.S. healthcare centers and is dependent on future acceptance of the new KDIGO guideline recommendation.

Analyst Q&A

• Q: An analyst asked when Telferra will begin commercial hiring, and what the commercial rollout strategy will be for Nefamostat after approval, including targeting high-volume sites. /

  A: Telferra has a right of first negotiation agreement with CoreMedix for a commercial partnership, with CoreMedix's CEO serving on Telferra's board. The company is preparing for independent launch while evaluating the partnership. Hiring for pre-launch medical education and planning will start after PMA submission in the first half of 2027, with only a small initial team. Because over 50% of U.S. CRRT procedures are concentrated at just 70 institutions, the rollout will be highly targeted, relying on account managers, medical educators, and peer-to-peer outreach rather than a large traditional sales force.

• Q: An analyst asked for clarification on the timeline from full enrollment to top-line data, PMA submission, and the gap between approval and launch, plus requested any notable feedback from trial principal investigators. /

  A: Top-line data will be available 4 to 5 weeks after enrollment closes, followed by a 3-month period to prepare and submit the PMA in the first half of 2027. Management plans to launch immediately upon FDA approval, with no pre-planned delay. The trial remains blinded, so no arm-specific feedback is available, but PIs report the procedure is straightforward, monitoring is predictable, and there have been no unexpected findings. Many PIs who currently use citrate have said they will wait for Nefamostat approval rather than investing in citrate infrastructure, due to Nefamostat's simpler administration.

• Q: An analyst asked for blinded insights on Nefamostat titration in the trial, and whether the KDIGO guideline recommends a different use pattern than Telferra plans for the U.S. /

  A: Blinded observations show titration is exactly aligned with expectations: most patients stay well below the maximum allowed dose, with 80% already in therapeutic range at the starting dose, and almost all patients within range within 30 minutes. Rare additional titration is completed within the first hour, which is a major advantage compared to the unpredictable titration required for heparin. The KDIGO draft lists Nefamostat as an alternative for patients where citrate is contraindicated or unavailable. In the U.S., 75% of institutions do not use citrate, creating immediate large market opportunity, even with the guideline's current wording.

• Q: An analyst asked when the final KDIGO guideline will publish, how quickly it will be adopted by U.S. institutions, and how closely U.S. clinicians follow KDIGO guidance. /

  A: Public comment closed in May 2026, so the final guideline is expected to publish within 3 to 6 months. Adoption varies by institution, but the recommendation formally validates Nefamostat's safety and efficacy, making it much easier for U.S. hospitals to develop local protocols and adopt Nefamostat after approval.