Talphera Q2 2026 Earnings Call - Nafamostat Enrollment Hits 75% Amid Expanded Market Opportunity

Operator: Welcome to Talphera’s second quarter 2026 financial results conference call. This call is being webcast live via the Events page at the Investors section of Talphera’s website at www.talphera.com. You may listen to a replay of this webcast by going to the Investors section of Talphera’s website. I would now like to turn the call over to Raffi Asadorian, Talphera’s Chief Financial Officer.

Raffi Asadorian, Chief Financial Officer, Talphera: Thank you for joining us on the call today. Today, we announced our second quarter 2026 financial results and associated business updates in a press release. With me today are Vince Angotti, our Chief Executive Officer, and Dr. Shakil Aslam, Talphera’s Chief Medical Officer. Before we begin, I want to remind listeners that during this call, we will likely make forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve risks and uncertainties regarding the operations and future results of Talphera. Please refer to our press release in addition to the company’s periodic, current, and annual reports filed with the SEC for a discussion of the risks associated with such forward-looking statements. These documents can also be found on our website within the Investors section. I’ll now hand the call over to Vince.

Vince Angotti, Chief Executive Officer, Talphera: Thanks, Rafi. Good afternoon, and thank you to everyone joining our call today. We remain on track to complete enrollment in the NEPHRO-CRRT study later this year. This registrational trial is designed to evaluate whether nafamostat is a safe and effective anticoagulant for use during continuous renal replacement therapy, or CRRT. The study is being conducted in hospital ICUs with nephrologists leading as principal investigators. With all of our final clinical sites now activated, we have reached 75% enrollment in the NEPHRO-CRRT study. This progress allows us to increasingly turn our attention to the commercial aspects of nafamostat. We remain especially pleased with the high level of engagement from our principal investigators and study site personnel. Today, we’ll share some details on these areas, along with some initial insights from our updated market research on nafamostat and the CRRT space.

On the commercial front, clinical guidelines are an important part of the treatment landscape and we’re encouraged by recent developments. Specifically, the KDIGO 2026 clinical practice guideline for acute kidney injury and acute kidney disease is currently pending final publication following the close of its public comment period in May. KDIGO, which stands for Kidney Disease: Improving Global Outcomes, is the global nonprofit organization that develops and implements evidence-based clinical practice guidelines in kidney disease. Of note, the guideline now references nafamostat as an acceptable regional anticoagulant. The only available regional anticoagulant being used in the U.S. today is citrate. Yet regional citrate’s not FDA approved for CRRT, and it’s also complex to use and has other limitations. As a result, most U.S. sites simply don’t incorporate it into their CRRT protocols.

This is the first time nafamostat has been recommended in the KDIGO guidelines, supported by historical studies and publications, a positive change from prior published recommendations. KDIGO guidelines are widely referenced by healthcare providers internationally. We believe this guideline will provide momentum for the commercialization of nafamostat, if approved. This new guidance should further highlight to healthcare professionals that nafamostat is already standard medical practice in Japan and South Korea, where it is the most widely used method of anticoagulation during CRRT. A 2018 national survey in Japan found that nafamostat was used in about 80% of cases, making it the most common method of circuit anticoagulation. In South Korea, nafamostat was approved for this use in 2005 and remains one of the most widely used anticoagulation methods today. In addition, our updated market research on the CRRT space points to a larger market opportunity for nafamostat than initially estimated.

This research puts the estimated annual CRRT procedures in 2027, the projected timing of a nafamostat launch, at approximately 200,000 in the U.S. That’s a 21% increase from our prior estimate of 165,000, driven by new data from this research. We also expect the number of CRRT procedures to continue growing annually. We believe nafamostat, if approved, can address an unmet need in the market given the disadvantages of systemic heparin and regional citrate. Addressing that unmet need provides nafamostat with an opportunity to gain a meaningful share of the CRRT anticoagulant market. These market insights are consistent with what we’re hearing directly from principal investigators and other physicians about the currently available CRRT anticoagulants. We’ll share the complete findings later this year at another investor and analyst event as we get closer to completing enrollment.

Now I’ll turn the call over to Dr. Aslam, our Chief Medical Officer, for some comments on the study. Shakeel?

Dr. Shakil Aslam, Chief Medical Officer, Talphera: Yes. Thanks, Vince, and good afternoon, everyone. I am very pleased with the progress we are seeing in the NEPHRO-CRRT study as we move toward completing enrollment later this year. We have completed the realignment of sites to match our target profile. Now all sites have nephrologists as the principal investigators and are recruiting patients primarily from the medical ICUs. Finalizing our study sites, coupled with protocol modifications granted by the FDA, has us on track to complete enrollment later this year. As a reminder, NEPHRO-CRRT is a placebo-controlled study in which administration, titration, and monitoring of anticoagulation are identical in both treatment arms. With 75% of patients enrolled, our investigators have consistently reported that these procedures are straightforward to perform.

The investigators continue to express their excitement over having nafamostat available for their use, if approved, and its inclusion in the public review draft of 2026 KDIGO guideline as a regional anticoagulant alternative to citrate. The international expert panel’s inclusion of nafamostat reflects decades of clinical experience and accumulated published evidence on the safety and efficacy of nafamostat as a regional anticoagulant during CRRT, and we look forward to sharing the study results with you. With that, I’ll hand the call over to Rafi to update you on the financial results for the second quarter. Rafi?

Raffi Asadorian, Chief Financial Officer, Talphera: Thanks, Shakeel. Our cash balance at June 30, 2026, was $17.1 million. We believe this cash, combined with future conditional financing tranches, will provide us sufficient capital through at least a potential Niyad PMA approval expected in 2027. Two conditional financing tranches remain, totaling approximately $16 million of additional capital. If the conditions are met, we expect these to close around the time we release our top-line data and announce the completion of the study. Our cash operating expenses, or combined R&D and SG&A expenses for the second quarter of 2026 totaled $3.9 million, compared to $3.7 million for the second quarter of 2025. Excluding non-cash stock-based compensation expense, these amounts were $3.7 million for the second quarter of 2026 compared to $3.5 million for the second quarter of 2025.

The $0.2 million increase in cash operating expenses in the second quarter of 2026 was primarily due to higher Niyad development expenses reflecting increased enrollment and certain SG&A expenses relating to initial market research activities. I’ll now hand the call over to Vince.

Vince Angotti, Chief Executive Officer, Talphera: Thank you, Rafi. Thank you for joining our second quarter earnings call. With enrollment progressing well, we remain on track to complete enrollment in the NEPHRO-CRRT registrational study later this year and to report top-line data soon thereafter. Our focus remains on bringing nafamostat to the market as a new regional anticoagulant for CRRT, if approved. I’d now like to open the line up for any questions you might have. Operator?

Operator: Ladies and gentlemen, we will now begin the question-and-answer session. If you have a question, please press the star followed by the one on a touch-tone phone. If you wish to cancel your request, please press the star followed by the two. If you’re using a speakerphone, please lift the handset before pressing any keys. Once again, that is star one if you wish to ask a question. Your first question is from James Molloy from Alliance Global Partners. Your line is now open.

Matt Molloy, Analyst, Alliance Global Partners: Hey, guys. Thanks for taking our questions. It’s Matt on for Jim today. As you guys are gearing up toward potential commercial launch here, when would we start to see maybe some strategic hires? Could you take us through a little bit of what the strategy might look like for a rollout, like centers of excellence that you guys may target, high enrolling sites that might want to come right on board? Anything like that color would be helpful. Thanks.

Vince Angotti, Chief Executive Officer, Talphera: Sure. Thanks, Matt. Appreciate it. I think a couple things that are important. I want to reiterate the fact that we do have a strategic potential with CorMedix, who has a right of first negotiation for 60 days post data readout. As a reminder, the CEO of CorMedix, Joseph Todisco, he is on our board and obviously knows everything going on with the company. So that’s one consideration. With that as a backdrop, we are preparing for launch on our own, as well as any other strategic considerations that might happen. More specific to the launch, we’ll likely start the hiring once the PMA is submitted. We plan that for early next year. First quarter is our goal. With that PMA submission, we would likely start to hire and launch our pre-launch planning and our medical education. So it won’t be a significant number of hires.

Just right now, as a preliminary plan, just a couple of hires, really about education on nafamostat as background, the KDIGO guidelines, et cetera. As a strategy for rollout in general, as you mentioned, if you recall, this market is highly concentrated. At least that’s what the data suggests to date, and we’ll be doing some additional targeting and segmentation work moving forward. But those 200,000 procedures that we mentioned in today’s call, based off of the most recent data we have, and we’ll validate moving further, about 70 institutions in the country, as far as we can tell, represent over 50% of those procedures. So from a rollout standpoint, we believe it’ll be highly targeted and concentrated and likely, at least today, not your traditional sales representative rollout. It’ll be more account managers and educators and trainers, and a lot of peer-to-peer education moving forward.

We believe it will be highly concentrated. I think a big focus for us will be on the pre-launch activities and medical education, and that will coincide once the PMA is submitted next year.

Raffi Asadorian, Chief Financial Officer, Talphera: Matt, just to correct that.

Matt Molloy, Analyst, Alliance Global Partners: Great. Yeah.

Raffi Asadorian, Chief Financial Officer, Talphera: Just to be clear on the PMA filing, it is not first quarter, first half is what been spoken.

Vince Angotti, Chief Executive Officer, Talphera: First half.

Matt Molloy, Analyst, Alliance Global Partners: First half. Yeah.

Raffi Asadorian, Chief Financial Officer, Talphera: Yeah.

Matt Molloy, Analyst, Alliance Global Partners: Gotcha. All right. Thanks, guys.

Vince Angotti, Chief Executive Officer, Talphera: Thanks, Ralph.

Matt Molloy, Analyst, Alliance Global Partners: Thanks for the color and thanks for taking our questions today.

Vince Angotti, Chief Executive Officer, Talphera: Of course.

Operator: Thank you. Your next question is from Ed Arce from WestPark Capital. Your line is now open.

Ed Arce, Analyst, WestPark Capital: Hi, guys. Thanks for taking my questions, and congrats on the continued progress with the trial. A couple questions from me. I just wanted to ask, as we are approaching full enrollment here, I wanted to ask if you could run through again, just to be clear on the timeline from full enrollment to the data collection, to the extent that there is much after that, and then top-line readout and the interim between that and what’s necessary to submit your PMA, as you mentioned, in the first half of next year. Separately from the timeline, I also wanted to ask if you have heard anything of note, anything particularly interesting in terms of feedback from these nephrologist PIs. You mentioned that the feeling has been the procedure remains quite straightforward. That’s one aspect of this that’s been repeated, I think, before.

But are there any other aspects of this as all the sites now are up and running? Thanks.

Vince Angotti, Chief Executive Officer, Talphera: Thanks, Ed, for the question. Ralph, I’ll refer to you for the timelines, and then we’ll move to Shakeel for the nephrology feedback relative to our PIs.

Raffi Asadorian, Chief Financial Officer, Talphera: Sure. Yeah, so to get the data, it’s going to be about 4 weeks after we complete enrollment. Around that time, 4 or 5 weeks, something like that, to get to the top-line data. We’re working to get that on the sooner end of that, but that’s probably around the timing. Then to get to a PMA filing, we may be requesting an interim meeting just to make sure everything is clear and everything, but we’re probably talking another couple of months or so, probably another 3 months or so to get to that PMA filing, which should put us inside that first half of next year. That answer your question, Ed?

Ed Arce, Analyst, WestPark Capital: Yes. I guess related to that, obviously, there’s the PMA approval that’s expected sometime around the middle of the year. Is there any necessary activities between approval and full launch? Any color on the timeline there as well?

Vince Angotti, Chief Executive Officer, Talphera: I would suggest-

Raffi Asadorian, Chief Financial Officer, Talphera: I think it. Okay.

Vince Angotti, Chief Executive Officer, Talphera: I would suggest likely not, Ed. If you are asking between approval and launch, our goal would be to launch at approval. Part of that would be what I will call market conditioning and sensitization to nafamostat and its availability in the medical education. I do not suggest there would be much of a delay between approval and a launch, at least how we are planning it today.

Ed Arce, Analyst, WestPark Capital: Got it.

Vince Angotti, Chief Executive Officer, Talphera: I think the second portion of your question was feedback from the nephrology PIs. Shakeel, do you want to comment on that? I think one other aspect outside of what we said today, Shakeel, if you wouldn’t mind mentioning how, at least based off of the early feedback as well, they’re using other agents often as second line, they might move nafamostat the first line when and if it’s approved.

Dr. Shakil Aslam, Chief Medical Officer, Talphera: Right. Ed, just remember that this is a blinded study, so there is no feedback that really pertains to one treatment arm versus the other. But overall, there have not been any surprises in the study, and their experience is exactly as they were expecting. Monitoring is extremely straightforward, simple, and very predictable. I think that’s two important things in this patient population that your response should be consistent and predictable. So far, that’s the feedback we have gotten. We have had our first independent data safety monitoring meeting a couple of months ago, and they did not identify any risks to the patient or any new findings, so they essentially recommended to continue the study without any changes. So that’s also very reassuring that everything is going as planned.

I can tell you that people who have used citrate or clinicians who were looking into using citrate, many of them have informed us, "Gee, I should just wait for this to become available. Why invest all these resources?" Because this is just going to be so much simpler and easier to use without any special training required. Essentially, the use is just very, very similar to heparin except that it’s just more predictable and more consistent in terms of the way the anticoagulation goes in these patients. So I hope that answered your question. There have been no surprises and everybody remains. I talk to PIs almost on weekly basis, and they all remain very excited and many of them have told me that they cannot wait to get their hands on it. So that, I think, is all very encouraging and quite as expected.

Ed Arce, Analyst, WestPark Capital: Yeah, that’s great. Thanks, Dr. Azam. I appreciate that.

Dr. Shakil Aslam, Chief Medical Officer, Talphera: Sure.

Ed Arce, Analyst, WestPark Capital: If I may, I just want to ask one quick question about the investor event planned. Is there any further details at this point that you could share? Thanks.

Vince Angotti, Chief Executive Officer, Talphera: Rob?

Raffi Asadorian, Chief Financial Officer, Talphera: No, not yet. It’s going to be focused on the market, the market opportunity, and our commercial approach to the market, and we’ll be providing more details on all the updated market research that we’ve been going through. That’s going to be a little closer to the time where we’re imminently completed with the study, so towards the fourth quarter.

Vince Angotti, Chief Executive Officer, Talphera: Just to give you a little more color, Ed, on Rob’s comment. We completed this in-depth market research with a data analysis provider on market sizing, growth rates, and stratification within it, meaning what are some of the most prominent disease states that are obviously related to CRRT. An example would be sepsis and then some others. Beyond that, what I’ll call secondary market research, we have just recently completed primary market research with over 30 physicians on both the quant and qual format. It was fully chaperoned as opposed to more of a survey, really getting insightful readouts from them on their feeling about today’s current products, the target product profile of a new entrant, for instance, nafamostat, how that might affect their use of products moving forward.

Does it shift them from second-line therapies as rescue with current anticoagulants to potentially a proactive first-line therapy use with a new entrant like nafamostat based off that TPP, et cetera. We’ve also done some recent research with some nurses to add some more qualitative feedback on just the burden that they have in the ICU in the often one-to-one ratios of workload once a patient goes on CRRT, especially involved with citrate. So we’re looking to finish the synthesis of all that data, package it properly, and that’ll allow us to think about the proper mechanisms for launch moving forward, all of which we’ll communicate to you in that investor event.

Ed Arce, Analyst, WestPark Capital: Fantastic. Thank you so much.

Vince Angotti, Chief Executive Officer, Talphera: You are welcome.

Operator: Thank you. Your next question is from Brendan Cox from H.C. Wainwright. The line is now open.

Brendan Cox, Analyst, H.C. Wainwright: Hi, thanks for taking my questions, and congrats on all the progress. Two from me. Apologize if they have been answered, just hopping between a few calls here. Firstly, do you have any blinded insight into the titration that is happening in the NEPHRO-CRRT clinical trial? Even if this is just through way of drug supply. If so, is there anything you can say whether that is tracking in line with expectations? Secondly, maybe just on the, I guess, KDIGO guidelines. I am assuming this is based on ex-U.S. usage and history. Is there anything in this draft guidance that is different to the way nafamostat would be used in the U.S.? I guess, are they recommending it in any different way than you envision it being used in the U.S.? That is it for me. Thank you.

Vince Angotti, Chief Executive Officer, Talphera: Shakeel, I think that’s right down your alley.

Dr. Shakil Aslam, Chief Medical Officer, Talphera: Okay.

Vince Angotti, Chief Executive Officer, Talphera: Any insights on, in particular, the titration or anything you can comment on, realizing it’s a blinded study?

Dr. Shakil Aslam, Chief Medical Officer, Talphera: Absolutely. The titration has been, again, it’s a blinded study, and with only limited information available. But overall, it’s behaving actually quite well, exactly as we were expecting. We had a maximum dose that we can give. There’s a ceiling on that dose. Most of patients in this study never really get even anywhere close to that dose. Most are titrated below half of the dose of the maximally allowed dose. That’s very, very good news. It’s exactly in the window where we wanted it. That’s very important that we only use the minimum amount of agent, nafamostat, to get a therapeutic effect. From that point of view, it’s quite aligned with it. And second thing that investigators point out is that there’s hardly any need to make multiple adjustments.

When patients, they feel it gets titrated, they remain at the same level. For some of these patients in the study have gone up to one week, and they did not need to go back up and down to re-titrate to stay in the therapeutic range. I think that’s a huge, huge advantage when you compare it to heparin, for example, where titration can be all over the place, and it’s actually so frustrating that many physicians actually just do not even titrate with heparin when they use for CRRT.

Vince Angotti, Chief Executive Officer, Talphera: Can you also remind them on the titration, how quickly it occurs as it relates to the protocol in the study?

Dr. Shakil Aslam, Chief Medical Officer, Talphera: Right. Roughly about 80% of the patients, they are within therapeutic range at the starting dose, that infusion rate that we have in our protocol. Within half an hour, almost 100% of the patients are within therapeutic range.

Vince Angotti, Chief Executive Officer, Talphera: That titration schedule, if they’re not, happens in the first hour, correct?

Dr. Shakil Aslam, Chief Medical Officer, Talphera: Right. We titrate every 15 minutes, and that’s guided by bedside blood test of ACT. Every 15 minutes you can change the dose, go up or go down. As I said, 80%, 85% of the patients are already therapeutic at the starting dose. Another 15% may need a one-up titration, which is relatively small. As opposed to 50 milligrams, which would be the highest dose, most patients are therapeutic around 20 to 25 milligrams per hour.

Vince Angotti, Chief Executive Officer, Talphera: I just want to reiterate that this is a blinded study. These are observations, but we’ll see the final results when obviously it’s unblinded. Shakeel, can you comment on the second question Brandon had

Dr. Shakil Aslam, Chief Medical Officer, Talphera: Right

Vince Angotti, Chief Executive Officer, Talphera: relative to the KDIGO guidelines and if those recommendations

Dr. Shakil Aslam, Chief Medical Officer, Talphera: Yeah

Vince Angotti, Chief Executive Officer, Talphera: are of any treatment patterns or different use than how we’re seeing it at ex-U.S.?

Dr. Shakil Aslam, Chief Medical Officer, Talphera: Right. Yeah, the guidelines, the way they are phrased right now is that this is an alternative to citrate. If there is a contraindication to use of citrate or if the citrate is not available, then this would be agents that could be used in that scenario. In the U.S., citrate use is around 25% of the patients or clinicians use citrate or the hospitals use citrate. Approximately 75% of the institutions do not have citrate available. Even within institutions where citrate is available, there are complexity to its use. It’s contraindicated in patients with liver disease, for example, and some other metabolic issues that can result from its use. There is a chunk of those patient institutions which do have access to citrate. They are not able to use citrate on every patient.

Now, in Japan and South Korea, there’s barely any use of citrate. So in those countries, this is their first-line agent. The way it’s worded for the rest of the world right now, KDIGO guideline, is that you should use citrate first, but if it’s not available or contraindicated, then you go to nafamostat as a use. But again, I think just because 75% of the U.S. facilities do not have access to citrate, I think there’s a pretty big chunk of market which will be a candidate for nafamostat right out of the gate. And within even the 25% segment that does use citrate, there’s a lot of difficulty and lot of labor-intense method that citrate uses. So there is a definitely desire to move away from citrate if a better and easier-to-use agent becomes available.

Brendan Cox, Analyst, H.C. Wainwright: All right. Thank you very much.

Dr. Shakil Aslam, Chief Medical Officer, Talphera: Sure.

Operator: Thank you. And your next question is from Naz Rahman from Maxim Group. Your line is now open.

Naz Rahman, Analyst, Maxim Group: Hi, everyone. Congrats on the progress, and thanks for taking my questions. Just a few. So on the KDIGO guidelines, could you comment on basically how long it takes or what are the next steps for this to become, I guess, confirmed or permanently approved guidelines. And following that, how quickly does this guideline get adopted by American institutions? And also, how closely is it followed by American institutions? And I guess not just in terms of anticoagulants for CRRT, but just in general.

Vince Angotti, Chief Executive Officer, Talphera: We’re going to move to Shakeel again.

Dr. Shakil Aslam, Chief Medical Officer, Talphera: Yeah, sure.

Vince Angotti, Chief Executive Officer, Talphera: On confirmation, once the commentary is done, Shakeel?

Dr. Shakil Aslam, Chief Medical Officer, Talphera: Yes. I unfortunately do not know the exact timeframe. They closed their public review comments in May of this year. My guess would be somewhere between 3 to 6 months, they will have the final draft. More like 3 months, I would say. In terms of its adoption within the U.S. institutions, it’s quite variable. These guidelines are well-known, and they are recognized by most healthcare professionals. But there is institutional variability within the U.S. like any other place. Some clinicians follow them very closely. Others would have their own kind of versions of guidelines. From our point of view, what this inclusion of nafamostat does is, number one, it validates that this is actually an acceptable, safe, and efficacious alternative to other therapies, and which has been used in other countries, and they are recommending, obviously, wider use of nafamostat.

Secondly, many institutions and clinicians, when they want to develop their own protocols for anticoagulation CRRT in their own institutions, having an international body of experts basically giving you a rationale and a recommendation, I think it really makes things much easier for them to adopt those recommendations at their own institutions. I think it just supports that, okay, well, this data has been reviewed by international group of panels and therefore you can go to the pharmacy and other stakeholders in the hospital and tell them that this is what you are going to do. From that point of view, I think it is also positive news for us.

Naz Rahman, Analyst, Maxim Group: Got it. Thank you.

Dr. Shakil Aslam, Chief Medical Officer, Talphera: Sure.

Operator: Thank you. There are no further questions at this time. Please proceed with the closing remarks.

Vince Angotti, Chief Executive Officer, Talphera: Thank you, operator. I just want to say thanks again to everyone on the call for your time with us today and your interest in Talphera. We are excited about the prospects moving forward and look forward to updating you on our progress. Operator, that concludes our call.

Operator: Thank you, ladies and gentlemen, the conference has now ended. Thank you all for joining. You may now disconnect your lines.