TALPHERA, INC. Q4 FY2025 earnings call

Business update: Announced Q4 and full year financial results. NEFRO CRRT study progressing, reached 50% enrollment milestone, triggered closing of third tranche of March 2025 financing generating $4.1 million gross proceeds. As of December 31st, had $20.4 million in cash in investments. Expect to complete NEFRO CRRT study enrollment later this year and file PMA within about three months after study completion. Introduction to key experts: Dr. McMahon and Dr. Teixeira, who are principal investigators in the NEFRO CRRT registrational study. Discussion on CRRT: Differences between CRRT/CKRT and regular intermittent hemodialysis. Epidemiological trends in end-stage kidney disease and acute kidney injury. Risk of clotting in ICU patients on CRRT compared to outpatient. Implications of filter clotting for clinicians, support staff, and patients. Anticoagulation methods: Current use of heparin and citrate, challenges and issues with each. Discussion on ideal anticoagulant for CRRT.

Expect to complete enrollment of NEFRO CRRT study later this year and file PMA within about three months after study completion. The third tranche of March 2025 financing generated $4.1 million in gross proceeds. Cash in investments as of December 31st was $20.4 million, which along with remaining tranches should provide runway through potential FDA approval next year. Study enrollment was affected by unexpected delays from two sites, but now enrolling pace is good with Dr. McMahon enrolling three patients last week. Goal is to have PMA submission in second half of the year.

Forward-looking statements involve risks and uncertainties regarding operations and future results. Study enrollment challenges due to strict exclusion criteria for patients with bleeding risk. Unexpected delays in study enrollment from two sites due to their internal processes.

Q: What are the key differences between CRRT, CKRT, and regular intermittent hemodialysis?

A: CRRT/CKRT is a more gentle form of continuous dialysis run 24/7 in the ICU for critically ill patients, lasting 5-7 days, while regular intermittent hemodialysis is done mostly outpatient for more stable patients, quick 3-4 hours.

Q: What are the implications when a filter clots?

A: Patient not receiving therapy, reducing effective delivered dose, valuable nursing time lost, costly filter replacement, and potential blood loss.

Q: What is the current strategy for anticoagulation?

A: Typically heparin or citrate, but both have challenges. Heparin has lack of efficacy and bleeding risk. Citrate has complex protocols, metabolic disturbances, and storage issues.

Q: When will the trial be completed and PMA filed?

A: Expect to complete enrollment later this year, file PMA within about three months after study completion. Delays occurred but pace is good now.

Q: How long does it take for nurses to get used to citrate vs niad if approved?

A: Citrate training requires advanced skilled CRT nurses, takes time. Niad if approved would be easy to use, train all upfront.

Q: Will the use of niad increase the market for CRRT anticoagulation?

A: Overwhelmingly, it is expected to increase as it is simpler and better than current options.

Q: What is the ideal candidate for niad in CRRT?

A: Almost all ICU patients on CRRT, including those excluded from the study due to conservative criteria, and may include liver patients.