Q2 2026 Talphera Inc Earnings Call
Speaker #1: Welcome to the TALPHERA second quarter 2026 financial results conference call. This call is being broadcast live via the events page of the Investors section of TALPHERA's website at www.talphera.com.
Speaker #1: You may listen to a replay of this broadcast 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.
Speaker #2: 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.
Speaker #2: With me today are Vincent 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.
Speaker #2: These forward-looking statements involve risks and uncertainties regarding the operations and future results of TALPHERA. Please refer to our press release, as well as the company's periodic, current, and annual reports filed with the SEC, for a discussion of the risks associated with such forward-looking statements.
Speaker #2: These documents can also be found on our website within the Investors section. I'll now hand the call over to Vincent.
Speaker #3: Thanks, Raffi. Good afternoon, and thank you to everyone joining our call today. We remain on track to complete enrollment in the NEFRO CRRT study later this year.
Speaker #3: This registrational trial is designed to evaluate whether NEFAMASTAT 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.
Speaker #3: With all of our final clinical sites now activated, we have reached 75% enrollment in the NEFRO CRRT study. This progress allows us to increasingly turn our attention to the commercial aspects of NEFAMASTAT.
Speaker #3: 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 NEFAMASTAT and the CRRT space.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: Of note, the guideline now references nefamostat as an acceptable regional anticoagulant. The only available regional anticoagulant being used in the U.S. today is citrate.
Speaker #3: 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.
Speaker #3: This is the first time NEFAMASTAT has been recommended in the KDGO guidelines, supported by historical studies and publications—a positive change from prior published recommendations.
Speaker #3: KDGO guidelines are widely referenced by healthcare providers internationally, and we believe this guideline will provide momentum for the commercialization of NEFAMASTAT if approved. This new guidance should further highlight to healthcare professionals that NEFAMASTAT is already standard medical practice in Japan and South Korea, where it is the most widely used method of anticoagulation during CRRT.
Speaker #3: A 2018 national survey in Japan found that nefamostat was used in about 80% of cases, making it the most common method of circuit anticoagulation.
Speaker #3: In South Korea, NEFAMASTAT 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 NEFAMASTAT than initially estimated.
Speaker #3: This research puts the estimated annual CRRT procedures in 2027, the projected timing of a NEFAMASTAT launch, at approximately 200,000 in the United States. That's a 21% increase from our prior estimate of 165,000, driven by new data from this research.
Speaker #3: We also expect a number of CRRT procedures to continue growing annually. We believe NEFAMASTAT, if approved, can address an unmet need in the market given the disadvantages of systemic heparin and regional citrate.
Speaker #3: Addressing that unmet need provides NEFAMASTAT with an opportunity to gain a meaningful share of the CRRT anti-coagulant market. These market insights are consistent with what we're hearing directly from principal investigators and other physicians about the currently available CRRT anti-coagulants.
Speaker #3: 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.
Speaker #3: Shakil?
Speaker #4: Yes, thanks, Vincent. And good afternoon, everyone. I am very pleased with the progress we are seeing in the NEFRO CRRT study. As we move toward completing enrollment later this year, we have completed the realignment of sites to match our target profile.
Speaker #4: As the principal investigators and our 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.
Speaker #4: As a reminder, NEFRO 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.
Speaker #4: The investigators continue to express their excitement over having NEFAMASTAT available for their use, if approved, and its inclusion in the public review draft of the 2026 KDIGO guideline as a regional anticoagulant alternative to citrate.
Speaker #4: The international expert panels' inclusion of nefamostat reflects decades of clinical experience and accumulated published evidence on the safety and efficacy of nefamostat as a regional anticoagulant during CRRT.
Speaker #4: And we look forward to sharing the study results with you. With that, I'll hand the call over to Raffi to update you on the financial results for the second quarter.
Speaker #4: Raffi.
Speaker #2: Thanks, Shakil. Our cash balance at June 30, 2026, was $17.1 million. We believe this cash, combined with future conditional financing tranches, will provide sufficient capital through at least a potential NIAID PMA approval expected in 2027.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: The $0.2 million increase in cash operating expenses in the second quarter of 2026 was primarily due to higher NIAID development expenses, reflecting increased enrollment, and certain SG&A expenses relating to initial market research activities.
Speaker #2: I'll now hand the call over to Vincent.
Speaker #3: Thank you, Raffi. And thank you for joining our second quarter earnings call. With enrollment progressing well, we remain on track to complete enrollment in the NEFRO registrational study later this year and to report top-line data soon thereafter.
Speaker #3: Our focus remains on bringing NEFAMASTAT to the market as a new regional anti-coagulant for CRRT if approved. And I'd like to open the line up for any questions you might have.
Speaker #3: Operator?
Speaker #5: Ladies and gentlemen, we will now begin the question-and-answer session. If you have a question, please press the star key, followed by the number one on your touchtone phone.
Speaker #5: Should you wish to cancel your request, please press the store, followed by 2. If you're using a speakerphone, please lift the handset before pressing any keys.
Speaker #5: Once again, that is store 1. Should you wish to ask a question? Your first question is from James Molloy from AGP Global Partners.
Speaker #5: Your line is now open.
Speaker #6: Hey, guys. Thanks for taking our questions. It's Matt on for Jim today. So, as you guys are gearing up toward potential commercial launch here, when would we start to see maybe some strategic hires?
Speaker #6: And 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?
Speaker #6: High-enrolling sites that might want to come right on board—anything like that color would be helpful. Thanks.
Speaker #3: Sure. Thanks, Matt. Appreciate it. I think a couple of things are important. I want to reiterate the fact that we do have a strategic potential with Cormetics, who has a right of first negotiation for 60 days post-data readout.
Speaker #3: And as a reminder, the CEO of Cormetics, Joe Tadisco, is on our board and obviously knows everything going on with the company. So that's one consideration.
Speaker #3: With that as a backdrop, we are preparing for launch on our own as well as considering any other strategic opportunities that might arise. More specifically regarding the launch, we'll likely start hiring once the PMA is submitted.
Speaker #3: We plan that for early next year, first quarter is our goal. And with that PMA submission, we would likely start to hire and launch our pre-launch planning and our medical education.
Speaker #3: So it won't be a significant number of hires—just right now, as a preliminary plan, just a couple of hires. Really, it's about education on NEFAMASTAT's background, the KDIGO guidelines, et cetera.
Speaker #3: 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.
Speaker #3: 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 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.
Speaker #3: So, from a rollout standpoint, we believe it will be highly targeted and concentrated. And likely, at least today, not your traditional sales representative rollout. It will be more account managers and educators and trainers.
Speaker #3: And a lot of peer-to-peer education moving forward. So again, we believe it will be highly concentrated. I think a big focus for us will be on the pre-launch activities and medical education.
Speaker #3: And that will all coincide once the PMA is submitted next year.
Speaker #2: And Matt, just to correct that, just to be clear: the PMA filing is not first quarter, first half is what Vincent—
Speaker #3: First half.
Speaker #4: First half, yeah.
Speaker #2: Yeah, yeah.
Speaker #6: Gotcha. All right. Thanks, guys.
Speaker #3: Thanks a lot.
Speaker #6: Thanks to the caller, and thanks for taking our questions today.
Speaker #3: Of course.
Speaker #5: Thank you. And your next question is from Ed Darcy from WestPark Capital. Your line is now open.
Speaker #7: Hi, guys. Thanks for taking my questions and congrats on the continued progress with the trial. A couple of questions for 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.
Speaker #7: As you mentioned, in the first half of next year. And then, 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?
Speaker #7: 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?
Speaker #7: Thanks.
Speaker #3: Thanks, Ed, for the question. Raf, I'll refer to you for the timelines, and then we'll move to Shakil for the nephrology feedback relative to our PIs.
Speaker #7: Sure.
Speaker #2: Yeah, so to get the data, it's going to be about four weeks after we complete enrollment. Around that time—four or five weeks, something like that—to get to the top-line data.
Speaker #2: We're working to get that on the sooner end of that, but that's probably around the timing. And then, to get to a PMA filing, we may be requesting an interim meeting just to make sure everything is clear and everything.
Speaker #2: But we're probably talking another couple of months or so, probably another three months or so to get to that PMA filing. Which we'll put us inside the should put us inside that first half of next year.
Speaker #2: Does that answer your question?
Speaker #7: Yes. I guess related to that, obviously, there's the PMA approval that's expected sometime around the middle of the year. But is there is there any necessary activities between approval and full launch?
Speaker #7: Any color on the timeline there as well?
Speaker #3: Yeah, I would suggest— I would suggest likely not. Ed, if you're asking between approval and launch, our goal would be to achieve approval. And part of that would be what I'll call market conditioning and sensitization to NEFAMASTAT and its availability in the medical education.
Speaker #3: I don't suggest there'd be much of a delay between approval and a launch, at least how we're planning it today.
Speaker #7: Got it.
Speaker #3: I think the second portion of your question was feedback from the nephrology PIs. Shakil, do you want to comment on that? And I think one other aspect, outside of what we said today—Shakil, if you don't mind mentioning how, at least based on the early feedback as well, they're using other agents often as second line.
Speaker #3: They might move NEFAMASTAT to first-line when and if it's approved.
Speaker #2: Right. So Ed, just remember that this is a blinded study. So there is no feedback that really pertains to one treatment arm versus the other.
Speaker #2: But overall, there have not been any surprises in the study, and their experiences are exactly as they were expecting. Monitoring is extremely straightforward, simple, and very predictable.
Speaker #2: I think that's two important things. In this patient population, your response should be consistent and predictable. And so far, that's the feedback we have gotten.
Speaker #2: We 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.
Speaker #2: 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."
Speaker #2: 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.
Speaker #2: So I hope that answered your question. There have been no surprises, and everyone I talked to—PIs almost on a weekly basis—and they all remain very excited. Many of them have told me that they cannot wait to get their hands on it.
Speaker #2: So that's, I think, it's all very encouraging and quite as expected.
Speaker #7: Yeah, that's great. Thanks, Dr. Atham. I appreciate that. If I may, I just want to ask one quick question about the investor event planned.
Speaker #7: Are there any further details at this point that you could share? Thanks.
Speaker #3: Raf?
Speaker #2: No, not yet. I mean, it's going to be focused on 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.
Speaker #2: That's going to be a little closer to the time where we're imminently completed with the study.
Speaker #7: Yeah, just to give you a little more color, Ed, on Raf's comment. So we completed this in-depth market research with the data analysis provider on the market sizing, growth rates, and stratification within it—meaning what are some of the most prominent disease states that are obviously related to CRT. An example would be sepsis, and then some others.
Speaker #7: Beyond that, what I'll call secondary market research, we have just recently completed primary market research with over 30 physicians in both the quant and qual format.
Speaker #7: It was fully chaperoned, as opposed to more of a survey—really getting insightful readouts from them on their feelings about today's current products, the target product profile of a new entrant—for instance, NEFAMASTAT—and how that might affect their use of products moving forward.
Speaker #7: 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 NEFAMASTAT, based off that TPP?
Speaker #7: Etc. 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 and the often one-to-one ratios of workload once a patient goes on CRRT, especially when involved with citrate.
Speaker #7: So we're looking to finish the synthesis of all that data, package it properly, and that will allow us to think about the proper mechanisms for launch moving forward.
Speaker #7: All of which we will communicate to you at that investor event. Fantastic. Thank you so much.
Speaker #3: You're welcome.
Speaker #1: Thank you. And your next question is from Brandon Fuchs from HC Wainwright. The lines are open.
Speaker #8: Hi, thanks for taking my questions, and congrats on all the progress. Two from me—I apologize if they've already been answered; I'm just hopping between a few calls here.
Speaker #8: But firstly, do you have any blinded insight into the titration that's happening in the nephro clinical trial? Even if this is just through the way of drug supply, and if so, is there anything you can say about whether that is tracking in line with expectations?
Speaker #8: Secondly, maybe just on the, I guess, Cadio guidelines, I'm assuming this is based on XUS usage and history. I guess, is there anything in those draft guidance that is different to the way NEFAMASTAT would be used in the US?
Speaker #8: I guess, are they recommending it in any different way than you envision it being used in the U.S.? That's it for me. Thank you.
Speaker #3: Shaquille, I think that's right down your alley. So, any insights on, in particular, the titration or anything you can comment on, realizing it's a blinded study?
Speaker #2: Absolutely. So, 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.
Speaker #2: So we had a maximum dose that we can give—there's a ceiling on that dose. So, patients in this study never really get even anywhere close to that dose.
Speaker #2: So most are titrated below half of the dose of the maximally allowed dose. So that's very, very good news. So it's exactly in the window where we wanted it.
Speaker #2: So that's very important that we only use the minimum amount of agent to NEFAMASTAT to get our therapeutic effect. So from that point of view, it's quite aligned with it.
Speaker #2: And the second thing that investigators point out is that there's hardly any need to make multiple adjustments. So, when a patient, they feel, gets titrated, they remain at the same level. For some of these patients in the study, they've gone up to one week.
Speaker #2: And they did not need to go back up and down to re-titrate to stay in the therapeutic range. So 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 just do not even titrate with heparin when they use it for CRRT.
Speaker #7: Can you comment? Can you also remind them about the titration—how quickly it occurs, as it relates to the protocol in the study?
Speaker #2: Right. So roughly about 80% of the patients, they are within therapeutic range at the starting dose that infusion rate that we have in our protocol.
Speaker #2: So within half an hour, almost 100% of the patients are within the therapeutic range.
Speaker #7: And that titration schedule, if they're not, happens in the first hour, correct?
Speaker #2: Right, right. So we titrate every 15 minutes, and that's guided by bedside blood tests of ACT. And so, every 15 minutes, you can change the dose—go up or go down.
Speaker #2: And as I said, 80–85% of the patients are already therapeutic at the starting dose, and then the other 15% may need one uptitration, which is relatively small.
Speaker #2: So, as opposed to 50 milligrams, which would be the highest dose, most patients are therapeutic around 20 to 25 milligrams per hour.
Speaker #7: I just want to reiterate that this is a blinded study. So, these are observations, but we'll see the final results when, obviously, it's unblinded.
Speaker #7: Shaquille, can you comment on the second question Brandon had relative to the cardio guidelines, and if those recommendations are driving any treatment patterns or different use than what we're seeing ex-US?
Speaker #2: Right. So, yes. The guidelines, the way they are phrased right now, state that this is an alternative to citrate. So, if there is a contraindication to the use of citrate, or if citrate is not available, then these agents could be used in that scenario.
Speaker #2: So, in the US, citrate use is around 25%—that is, about 25% of patients or clinicians use citrate or the hospitals use citrate. So, approximately 75% of institutions do not have citrate available.
Speaker #2: And even within institutions where citrate is available, there are complexities to its use. So, it's contraindicated in patients with liver disease, for example, and there are some other metabolic issues that can result from its use.
Speaker #2: And so, there is a chunk of those patient institutions which do have access to Citrate. They are not able to use Citrate on every patient.
Speaker #2: 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, CARDIO guidelines state that you should use citrate first, but if it's not available or contraindicated, then you go to nafamostat as a use.
Speaker #2: But again, I think just because 75% of the US facilities do not have access to Citrate, I think this is a pretty big chunk of market which will be a candidate for NEFAMASTAT right out the gate.
Speaker #2: And within even the 25% segment that does use citrate, there's a lot of difficulty and a lot of labor-intensive methods that citrate uses. So there is a definite desire to move away from citrate if a better and easier-to-use agent becomes available.
Speaker #1: Great. Thank you very much.
Speaker #2: Sure.
Speaker #3: Thank you. And your next question is from Naz Rahman from Maxim Group. Carolina, is that open?
Speaker #7: Hi everyone. Congrats on the progress and thanks for taking my questions. Just a few. So on the Cadio 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?
Speaker #7: 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.
Speaker #7: We're going to move to Shakil again. So on confirmation, what's the comment period done? Shakil?
Speaker #2: Yes, yeah. So I unfortunately do not know the exact timeframe. They closed their public review comments in May of this year, so my guess would be somewhere between three to six months.
Speaker #2: They will have the final draft more like three months, I would say. And in terms of its adoption within the US institutions, it's quite variable.
Speaker #2: So these guidelines are well known and they are recognized by most healthcare professionals. But there is institutional variability within the US, like any other place.
Speaker #2: Some clinicians follow them very closely; others have their own versions of the guidelines. So, from our point of view, what the inclusion of NEFAMASTAT does is, number one, it validates that this is actually an acceptable, safe, and efficacious alternative to other therapies, which has been used in other countries. They are obviously recommending wider use of NEFAMASTAT.
Speaker #2: And 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 recommendation I think it really makes things much easier for them to adopt those recommendations at their own institutions.
Speaker #2: So 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 want to do and so from that point of view, I think it's also positive news for us.
Speaker #7: Got it. Thank you.
Speaker #2: Sure.
Speaker #3: Thank you. There are no further questions at this time. Please proceed with the closing remarks.
Speaker #7: 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.
Speaker #7: We're excited about the prospects moving forward and look forward to updating you on our progress. Operator, that concludes our call.
Speaker #3: Thank you. Ladies and gentlemen, the conference has now ended. Thank you all for joining. May now disconnect your lines.
