TALPHERA, INC. Q3 FY2025 earnings call

• Completed first closing of $17 million financing, including CorMedix's $5 million strategic minority investment with a 60-day exclusive negotiation period post nephro study top-line data. CorMedix's CEO appointed to Talphera's board. • Restructured nephro clinical study by changing site/investigator profiles, reducing study size to 70 patients to accelerate completion, with continued enrollment at existing sites and new institutions showing strong enrollment potential. • Delays in activating six new target profile sites pushed study completion to first half of 2026; specific reasons for delays include institutional restructuring and approval process changes. • Positive feedback from investigators on Nefamostat as preferred CRRT anticoagulant. • Doctor Aslam discussed enrollment progress at existing sites and detailed reasons for new site activation delays. • Emphasized low clinical, regulatory, and commercial risks for Nefamostat program due to product track record, FDA regulatory path, and market need for alternative anticoagulants.

• Cash balance at September 30, 2025, was $21.3 million, with sufficient capital for at least NIAID PMA approval expected next year. • Revised cash operating expense guidance from $16-17 million to $14-15 million for 2025 due to delays in new clinical site activation, with the difference realized in 2026.

• Delays in activating new clinical sites impacting study completion timeline. • Potential impact of federal government funding issues on academic institutions, though not widely affecting the sites discussed.

Q: Hi, everyone. Thanks for taking my questions. First, just want to start on the enrollment. The new target sites that have already been activated, are you finding that they're enrolling patients faster? Or I guess have the rates of patient enrollment increased? Because the last time when you last communicated the 17 patients, that was in August, and you still don't have the 35 patients. So it seems like mathematically, you're enrolling less than two patients a week. So I'm kind of left wondering why aren't the sites enrolling faster, the ones that have already been activated?

A: Yeah. No. The original sites that we communicated last time, there were three of them. Three of them only. And they hadn't enrolled the original five patients, right? Only when you put those three additional sites on did you see the movement from the five patients to the 17, and we're beyond the 17 now. So we're seeing a fairly similar rate of enrollment that we had seen before, similar rate of consents, enrollment, screening, etcetera. So we're well beyond that 17. But in order for us to achieve an accelerated enrollment, we need to layer on these additional sites.

Q: And, one more question, if I may. I know you're talking about these new target sites and these they're seeing delays. But I was also curious, obviously, there's been a lot of volatility in the federal government, and that affected funding for a bunch of medical and all academic institutions. Has that kind of played in or had any factor in any of these organizations? Their ability to conduct clinical study, whether staffing or other leadership or structural issues, has that affected anything?

A: Yeah. I'll I have not received that feedback from any of the sites, but I'll turn it to Doctor Aslam to see if he's gotten any additional insight as he speaks to these sites often weekly, if not daily.

A: Sure. Yes, so one of the sites which is Veterans Affairs Medical Center, they did have some issues earlier on of some cuts into their personnel. They are over that, but that did unfortunately add approximately, I would say, three to four months to their timeline. But the rest of the sites have not been affected by that.

A: And that VA site, Nazibur, is not one that is currently enrolling. Doctor Aslam, when he says, adds the four months to it, that's until enrollment occurs. So we expect them before the end of the year now.