TLPH

Image source: The Motley Fool. Wednesday, Aug. 12, 2026 at 4:30 p.m. ET Chief Financial Officer - Raffi Asadorian Chief Executive Officer - Vincent Angotti Chief Medical Officer - Shakil Aslam Need a quote from a Motley Fool analyst? Email [email protected] Operator: Welcome to the Talphera Second Quarter 2026 Financial Results Conference Call. This call is being webcast live via the Events page of 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: 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. Vincent Angotti: Thanks, Raffi. 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 is 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 United States. That's a 21% increase from a 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. Thank you. Shakil? Shakil Aslam: 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. 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 results with you. With that, I'll hand the call over to Raffi to update you on the financial results for the second quarter. Raffi Asadorian: 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 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 is 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. Vincent Angotti: 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 NEPHRO 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 like to open the line up for any questions you might have. Operator? Operator: [Operator Instructions] Your first question is from James Molloy from Alliance Global Partners. Matthew Venezia: 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? 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, high enrolling sites that might want to come right on board, anything like that color would be helpful. Vincent Angotti: Sure. Thanks, Matt. Appreciate it. I think a couple of 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. And as a reminder, the CEO of CorMedix, Joe 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. And 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. And 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 significant number of hires, just right now as a preliminary plan, just a couple of hires really about education on nafamostat's 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 will 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 will be highly targeted and concentrated and likely, at least today, not your traditional sales representative rollout. It'd be more account managers and educators and trainers, 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 in medical education. And that will coincide once the PMA submitted next year. Raffi Asadorian: And Matt, just to correct. Just to be clear on the PMA filing, not first quarter, first half is what it's supposed to be. Vincent Angotti: First half, yes. Yes. Operator: Your next question is from Ed Arce from WestPark Capital. Antonio Arce: 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, 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? You mentioned that the feeling has been that 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. Vincent Angotti: Thanks, Ed, for the question. Raffi, I'll refer to you for the timelines, and then we'll move to Shakil for the nephrology feedback relative to our PIs. Raffi Asadorian: Yes, 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. And 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 months or so, probably another 3 months or so to get to that PMA filing, which will put us inside the -- should put us inside that first half of next year. Does that answer your question? Antonio Arce: 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 any necessary activities between approval and full launch? Any color on the timeline there as well? Vincent Angotti: Yes, I would suggest likely not, Ed. If you're asking between approval and launch, our goal would be to launch at approval. And part of that would be what I'll call market conditioning and sensitization to nafamostat and its availability and the medical education. I don't suggest there'd be much of a delay between approval and a launch, at least how we're planning it today. I think the second portion of your question was feedback from the nephrology PIs. Shakil, you want to comment on that? And I think one other aspect outside of what we said today, Shakil, if you wouldn't mind mentioning how, at least based off of the early feedback as well, they're using other agents often second line. They might move nafamostat to first line when and if it's approved. Shakil Aslam: 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. But overall, there have not been any surprises in the study. And their experience is exactly as they were expecting. Their 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. And 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 continued -- 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 citrate. 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 answers your question. There have been no surprises and everybody remains -- I talk to PIs almost on a 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's, I think, it's all very encouraging and quite as expected. Antonio Arce: Yes, that's great. Thanks, Dr. Aslam. I appreciate that. 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. Vincent Angotti: Raffi? Raffi Asadorian: No, not yet. I mean, 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. Vincent Angotti: Just to give you a little more color, Ed, on Raffi's comment, so 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 1-to-1 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. Operator: Your next question is from Brandon Folkes from H.C. Wainwright. Brandon Folkes: Congrats on all the progress. Two for me. I apologize if they've been answered, just hopping between a few calls here. 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 way of drug supply, and if so, is there anything you can say whether that is tracking in line with expectations? Secondly, maybe just on the, I guess, on the KDIGO guidelines. I'm assuming this is based on ex-U.S. usage and history. Is there anything in those 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's it for me. Thank you. Vincent Angotti: Shakil, I think that's right down your alley. So any insights on particular titration or anything you can comment on, realizing it's a blinded study? Shakil Aslam: 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. So we had a maximum dose that we can give. There's a ceiling on that dose. So most of patients in this study never really get even anywhere close to that dose. 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. So that's very important that we only use a minimum amount of agent to nafamostat, to get a therapeutic effect. So 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. So when patients, they feel it gets titrated, they remain at the same level. For some of these patients, the study had gone up to 1 week, and they did not need to go back up and down to retitrate 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 actually just do not even titrate with heparin when they use for CRRT. Vincent Angotti: Can you also remind them on the titration, how quickly it occurs as it relates to the protocol in the study? Shakil Aslam: 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. So within half an hour, almost 100% of the patients are within therapeutic range. Vincent Angotti: And that titration schedule, if they're not, happens in the first hour, correct? Shakil Aslam: Right, right. So we titrate every 15 minutes and that's guided by bedside blood test of ACT. So every 15 minutes you can change the dose, go up or go down. As I said, 80% to 85% of the patients are already therapeutic at the starting dose and another 15% may need 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 milligram per hour. Vincent Angotti: 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. Shakil, can you comment on the second question Brandon had relative to the KDIGO guidelines and if those recommendations are of any treatment patterns or different use than how we're seeing it ex-U.S.? Shakil Aslam: Right, so the guidelines, the way they are phrased right now is that this is an alternative to citrate, so if there is contraindication to use of citrate or if the citrate is not available, then this would be agents that could be used in that scenario. So in the U.S., citrate use is around 25% of the patients or clinicians use citrate or the hospitals use citrate. So approximately 75% of the institutions do not have citrate available. And even within institutions where citrate is available, there are complexity to its use. So it's contraindicated in patients with liver disease, for example, and some other metabolic issues that can result from its use. 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. Now, in Japan and South Korea, there's barely any use of citrate, so in those countries, this is the first-line agent. So the way it's worded for the rest of the world right now, the 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 the gate. And within even the 25% segment that does use citrate, there's a lot of difficulty and a lot of labor-intense method that citrate uses, so there is a definitely a desire to move away from citrate if a better and easier-to-use agent becomes available. Operator: Your next question is from Naz Rahman from Maxim Group. Nazibur Rahman: Congrats on the progress. 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. Vincent Angotti: We're going to move to Shakil again. So on confirmation, once the commentary is done, Shakil? Shakil Aslam: Yes. 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 3 to 6 months, they will have the final draft. More like 3 months, I would say. And in terms of its adoption within U.S. institutions, it's quite variable. So 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. So from our point of view, what the 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. 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 rationale and recommendation, I think it really makes things much easier for them to adopt those recommendations at their own institutions. 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 are going to do. And so from that point of view, I think it's also positive news for us. Operator: There are no further questions at this time. Please proceed with the closing remarks. Vincent Angotti: 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're 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. Before you buy stock in Talphera, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Talphera wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $419,408!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,348,694!* That performance is why people listen. 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Talphera (TLPH) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Enrollment in the NEPHRO CRRT registrational study has reached 75%, with completion expected later this year following successful site realignment to focus on nephrologists in medical ICUs. Management highlighted the inclusion of nafamostat as an acceptable regional anticoagulant in the 2026 KDIGO draft guidelines, marking the first time the drug has been recommended by this global body. Updated market research indicates a 21% increase in the estimated annual U.S. CRRT procedure volume to 200,000 by 2027, suggesting a larger commercial opportunity than previously modeled. The company is positioning nafamostat as a simpler, more predictable alternative to regional citrate, which is currently not FDA-approved for CRRT and is avoided by approximately 75% of U.S. institutions due to complexity. Operational feedback from blinded study sites indicates that the titration and monitoring procedures are straightforward, aligning with management's goal of providing a user-friendly anticoagulation method. Strategic flexibility is maintained through a right of first negotiation held by CorMedix, whose CEO sits on Talphera's board, providing potential for a partnered commercial path. Top-line data readout is anticipated approximately four to five weeks after enrollment completion, followed by a planned PMA submission in the first half of 2027. The commercial strategy targets a highly concentrated market where 70 institutions represent over 50% of U.S. CRRT procedures, favoring a model of account managers and medical educators over a traditional sales force. Cash runway is projected to last through at least a potential PMA approval in 2027, supported by $17.1 million in current cash and $16 million in conditional financing tranches tied to study milestones. Pre-launch activities, including medical education and market conditioning, are scheduled to commence immediately following the PMA submission to ensure a launch-at-approval trajectory. An independent data safety monitoring board meeting held recently resulted in a recommendation to continue the NEPHRO study without modifications, identifying no new patient risks. Management noted that while KDIGO guidelines provide international validation, U.S. institutional adoption remains variable and subject to individual hospital protocol development. Operating expenses saw a modest increase to $3.9 million in Q2 2026, primarily driven by higher clinical development costs associated with increased patient enrollment. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Hiring for medical education and pre-launch planning will begin in the first half of 2027 following the PMA submission. The rollout will be highly targeted toward approximately 70 key institutions, focusing on peer-to-peer education rather than a large-scale sales representative model. Approximately 80% to 85% of patients reach therapeutic range at the initial starting dose, with titration typically occurring within the first hour. Investigators report that once therapeutic levels are achieved, patients remain stable without the frequent 'up and down' adjustments common with heparin. The guidelines validate nafamostat as a safe alternative, which management believes will simplify the process for hospital pharmacies to adopt the drug into local protocols. While the draft currently lists nafamostat as an alternative when citrate is contraindicated, management expects high interest due to the 75% of U.S. facilities that currently lack citrate access.

This article first appeared on GuruFocus. Cash Balance: $17.1 million as of June 30, 2026. Cash Operating Expenses: $3.9 million for Q2 2026, compared to $3.7 million in Q2 2025. Cash Operating Expenses (excl. stock-based compensation): $3.7 million for Q2 2026, compared to $3.5 million in Q2 2025. Expense Increase: $0.2 million increase in Q2 2026, driven by higher Niyad development expenses and initial market research activities. Conditional Financing Tranches: Two tranches remain, totaling approximately $16 million in additional capital, expected to close around top-line data release. Warning! GuruFocus has detected 5 Warning Signs with TLPH. Is TLPH fairly valued? Test your thesis with our free DCF calculator. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Talphera Inc (NASDAQ:TLPH) has reached 75% enrollment in the NEPHRO CRRT study, with all final clinical sites activated and enrollment on track to complete later this year. The 2026 KDIGO clinical practice guideline now references nafamostat as an acceptable regional anticoagulant, marking the first time it has been recommended in these guidelines and providing momentum for commercialization. Updated market research indicates a larger market opportunity than initially estimated, with approximately 200,000 annual CRRT procedures expected in the US by 2027, a 21% increase from the prior estimate of 165,000. Nafamostat is already standard medical practice in Japan and South Korea, where it is the most widely used anticoagulant during CRRT, with usage in about 80% of cases in Japan. The company has sufficient cash, combined with future conditional financing tranches totaling approximately $16 million, to fund operations through at least a potential Niyad PMA approval expected in 2027. Investigators have reported that nafamostat titration is straightforward, with 80-85% of patients reaching therapeutic range at the starting dose and maintaining it without multiple adjustments, unlike heparin. The company has a strategic potential with CorMedix, which has a right of first negotiation for 60 days post data readout, potentially providing a commercialization pathway. Talphera Inc (NASDAQ:TLPH) has a cash balance of only $17.1 million as of June 30, 2026, which may be insufficient if the conditional financing tranches do not close as expected. The NEPHRO CRRT study is still blinded, and the company has not yet reported top-line data, leaving uncertainty about the trial's final results. The KDIGO guideline currently positions nafamostat as an alternative to citrate, not a first-line therapy, which may limit initial adoption in the US where citrate is preferred in some institutions. The company plans to hire only a couple of employees for pre-launch activities after PMA submission, which may be insufficient for a full commercial rollout. The PMA filing is expected in the first half of next year, but the timeline could be delayed if the FDA requires additional meetings or data, pushing back the potential launch. The market opportunity is concentrated in about 70 institutions representing over 50% of procedures, making the company's success highly dependent on a small number of key accounts. The company has not yet provided a detailed timeline for the final KDIGO guideline publication, which could be delayed and affect commercialization momentum. Q: As you gear up toward a potential commercial launch, when would we start to see strategic hires, and what might the rollout strategy look like, such as targeting centers of excellence or high-enrolling sites? A: Vincent Angotti (CEO) stated that while Talphera has a strategic option with CorMedix, which holds a right of first negotiation for 60 days post-data readout, the company is preparing for launch independently. Hiring is expected to begin after the PMA submission, targeted for the first half of next year, with a focus on medical education roles rather than a traditional sales force. The rollout will be highly targeted, as data suggests approximately 70 institutions account for over 50% of the estimated 200,000 annual CRRT procedures, emphasizing account managers, educators, and peer-to-peer training. Q: Can you clarify the timeline from full enrollment to data collection, top-line readout, and the subsequent steps needed to submit the PMA? A: Raffi Asadorian (CFO) explained that top-line data is expected approximately four to five weeks after completing enrollment. Following that, the company may request an interim meeting with the FDA to ensure clarity, adding roughly another three months before the PMA filing, which would place the submission within the first half of next year. Q: Are there any necessary activities between PMA approval and a full commercial launch? A: Vincent Angotti (CEO) indicated that the goal is to launch at the time of approval, with no significant delay anticipated. Pre-launch activities, including market conditioning and medical education, are planned to coincide with the PMA submission to ensure readiness for an immediate launch upon approval. Q: Have you received any notable feedback from the nephrologist principal investigators regarding the trial, and are there any insights into how they might use nafamostat if approved? A: Dr. Shakil Aslam (CMO) reported that the study is proceeding without surprises, with monitoring described as straightforward, simple, and predictable. The first independent Data Safety Monitoring meeting identified no risks or new findings. Many clinicians currently using or considering citrate have expressed they would prefer to wait for nafamostat, as it is simpler to use and requires no special training, with some indicating they would shift from using other agents as a second-line therapy to nafamostat as a proactive first-line therapy. Q: Do you have any blinded insight into the titration happening in the NEPHRO CRRT trial, and is it tracking in line with expectations? A: Dr. Shakil Aslam (CMO) shared that while the study is blinded, the titration is behaving as expected. Most patients are titrated below half of the maximum allowed dose, with roughly 80-85% achieving therapeutic range at the starting dose and nearly 100% within half an hour. Patients often remain at the same dose for up to a week without needing retitration, a significant advantage over heparin, which often requires frequent adjustments. Q: Regarding the KDIGO guidelines, is the recommendation for nafamostat based on ex-US usage, and does it differ from how you envision it being used in the US? A: Dr. Shakil Aslam (CMO) clarified that the draft guideline positions nafamostat as an alternative to citrate when citrate is contraindicated or unavailable. Since approximately 75% of US institutions do not have citrate available, this represents a substantial market opportunity. Even among the 25% that use citrate, its complexity and labor-intensive nature create a desire to switch to a simpler agent like nafamostat. In Japan and South Korea, where citrate is rarely used, nafamostat is already the first-line agent. Q: What are the next steps for the KDIGO guidelines to become final, and how quickly are they typically adopted by US institutions? A: Dr. Shakil Aslam (CMO) estimated the final guidelines could be published within three to six months following the close of the public comment period in May. Adoption in the US is variable, but the inclusion of nafamostat validates its safety and efficacy and provides institutional stakeholders with a strong rationale to develop their own protocols, making it easier to adopt the recommendation. Q: Can you provide any further details on the upcoming investor and analyst event? A: Raffi Asadorian (CFO) stated that the event will focus on the market opportunity and commercial approach, providing details on updated market research. Vincent Angotti (CEO) added that the research includes data on market sizing, growth rates, and stratification by disease states like sepsis, along with primary research from over 30 physicians and qualitative feedback from nurses on the burden of current anticoagulation methods. The synthesis of this data will inform launch mechanisms and be shared at the event. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Talphera, Inc.? Here are five stocks we like better. NEPHRO-CRRT enrollment reached 75%, with completion expected later in 2026. Talphera anticipates top-line data four to five weeks afterward and plans to submit a PMA for nafamostat in the first half of 2027, pending successful trial results and FDA review. Draft 2026 KDIGO guidelines reference nafamostat as an alternative regional anticoagulant for CRRT when citrate is unavailable or unsuitable. Talphera said the U.S. market could reach approximately 200,000 annual CRRT procedures in 2027, up from its prior estimate of 165,000. The company reported $17.1 million in cash as of June 30, 2026, plus approximately $16 million in conditional financing tranches. Second-quarter cash operating expenses rose to $3.7 million excluding stock compensation, driven mainly by increased NIYAD development and market research costs. Talphera (NASDAQ:TLPH) said it had reached 75% enrollment in its NEPHRO-CRRT registrational study and remains on track to complete enrollment later in 2026, as the company prepares for a potential commercial launch of its nafamostat anticoagulant candidate for continuous renal replacement therapy, or CRRT. Chief Executive Officer Vince Angotti said all final clinical sites are now activated for the placebo-controlled study, which is evaluating nafamostat’s safety and effectiveness as an anticoagulant used during CRRT. The trial is being conducted in hospital intensive care units, with nephrologists serving as principal investigators. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be “With all of our final clinical sites now activated, we have reached 75% enrollment in the NEPHRO-CRRT study,” Angotti said. “This progress allows us to increasingly turn our attention to the commercial aspects of nafamostat.” Chief Financial Officer Raffi Asadorian said Talphera expects top-line data about four to five weeks after completing enrollment. The company could then take roughly three additional months to prepare a premarket approval, or PMA, filing, potentially including an interim meeting with the FDA. Talphera expects to submit the PMA in the first half of 2027. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand Angotti said the company’s current plan is to launch nafamostat upon any approval, without a meaningful interval between approval and commercialization. However, the product has not been approved. Chief Medical Officer Dr. Shakil Aslam said the study’s site realignment had been completed, with all sites now led by nephrologists and recruiting primarily from medical ICUs. He said the FDA had also granted protocol modifications that support the company’s enrollment timeline. → Apple’s Next iPhone Could Test How Much Pricing Power Is Left Aslam said investigators have found the trial procedures straightforward, though he emphasized that NEPHRO-CRRT is blinded and that feedback does not distinguish between treatment arms. The company’s first independent data safety monitoring meeting occurred several months ago, according to Aslam, and the monitoring group recommended continuing the study without changes after identifying no new patient risks or findings. Based on limited blinded observations, Aslam said titration has been in line with Talphera’s expectations. He said roughly 80% to 85% of patients were in the therapeutic range at the protocol’s starting infusion rate, while nearly all patients reached that range within about 30 minutes. The protocol allows dose adjustments every 15 minutes using bedside activated clotting time testing. Aslam also said most patients have remained well below the protocol’s maximum permitted dose and generally have not required repeated dose adjustments after reaching the therapeutic range. Management highlighted the public-review draft of the 2026 clinical practice guideline for acute kidney injury and acute kidney disease from Kidney Disease: Improving Global Outcomes, or KDIGO. Angotti said the draft guideline references nafamostat as an acceptable regional anticoagulant, marking the first time the drug has been recommended in KDIGO guidance. The public comment period for the guideline closed in May. Aslam said he did not know the exact timeline for final publication but estimated that a final draft could be available within three to six months. According to Aslam, the current draft frames nafamostat as an alternative when citrate is unavailable or contraindicated. He said citrate is used by about 25% of U.S. institutions, while approximately 75% of institutions do not have it available. He also cited citrate’s complexity and potential limitations in patients with liver disease and certain metabolic issues. Angotti said citrate is the only regional anticoagulant currently used in the U.S., though he noted it is not FDA-approved for CRRT. He said nafamostat is already widely used during CRRT in Japan and South Korea. Talphera cited a 2018 Japanese national survey in which nafamostat was used in about 80% of cases. Management said KDIGO’s inclusion of nafamostat could help institutions develop their own CRRT anticoagulation protocols if the product receives approval. Aslam said the guidelines are widely known among U.S. healthcare professionals, although institutional adoption may vary. Talphera updated its estimate of the U.S. CRRT market, projecting approximately 200,000 annual procedures in 2027, the anticipated timing of a potential nafamostat launch. That estimate is 21% higher than the company’s prior estimate of 165,000 procedures. Angotti said Talphera expects the number of CRRT procedures to continue increasing annually and believes nafamostat could address unmet needs associated with systemic heparin and regional citrate. He said the market appears concentrated, with approximately 70 institutions representing more than half of the estimated procedure volume. The company expects its initial commercial approach to focus on targeted accounts rather than a traditional broad sales-force rollout. Angotti said Talphera would likely employ account managers, educators and trainers, supported by peer-to-peer medical education. Talphera expects initial hiring to begin after a PMA submission in the first half of 2027, with only a small number of early hires planned. The company also noted that CorMedix has a 60-day right of first negotiation following a data readout, which Angotti said remains a consideration as Talphera evaluates commercialization plans. Talphera plans to hold an investor and analyst event closer to the expected completion of enrollment, likely in the fourth quarter, to discuss its market research and commercial approach. Management said it has conducted research on market sizing, disease-state segmentation, physician views on current treatment options and nursing workload related to CRRT anticoagulation. Asadorian reported cash of $17.1 million as of June 30, 2026. He said the company believes its cash balance, together with future conditional financing tranches, will provide sufficient capital through at least a potential NIYAD PMA approval expected in 2027. Two conditional financing tranches remain available, totaling approximately $16 million, Talphera said. If their conditions are met, the company expects the tranches to close around the release of top-line data and the announcement of study completion. Cash operating expenses, comprising research and development and selling, general and administrative expenses, totaled $3.9 million in the second quarter, compared with $3.7 million a year earlier. Excluding non-cash stock-based compensation, cash operating expenses were $3.7 million, up from $3.5 million in the prior-year quarter. Asadorian attributed the $200,000 increase in cash operating expenses primarily to higher NIYAD development costs associated with increased enrollment and certain selling, general and administrative expenses tied to initial market research activities. Talphera, Inc, a specialty pharmaceutical company, focuses on the development and commercialization of therapies for use in medically supervised settings. Its lead product candidate is Niyad, a lyophilized formulation of nafamostat, which is under an investigational device exemption as an anticoagulant for the extracorporeal circuit. It is also developing LTX-608, an anti-inflammatory and antiviral potential for the treatment of multiple conditions, including disseminated intravascular coagulation (DIC), acute respiratory distress syndrome (ARDS), and acute pancreatitis; Fedsyra, a pre-filled ephedrine syringe; and PFS-02, a pre-filled phenylephrine syringe. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Talphera Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

NEPHRO CRRT clinical study of nafamostat is 75% enrolled; expected to be complete this year Draft 2026 KDIGO guidelines added nafamostat as an acceptable CRRT anticoagulant, a positive change from previous guidelines Updated market research indicates an estimated 200,000 annual U.S. CRRT procedures, a 21% increase over prior estimates; investor event planned as enrollment nears completion Cash and investments of $17.1 million at June 30, 2026 Conference call and webcast to be held on Wednesday August 12, 2026 at 4:30 pm ET SAN MATEO, Calif., Aug. 12, 2026 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced financial results for the second quarter of 2026 and provided a corporate update on the development of nafamostat. "Reaching 75% enrollment in the NEPHRO CRRT study keeps us on track for completion by year-end," stated Vince Angotti, CEO of Talphera. "Site realignment is complete, with all target clinical sites now activated. We are particularly pleased with the high level of engagement from our principal investigators and study site personnel." "In addition, the evolving treatment landscape continues to reinforce the potential role for nafamostat in CRRT. The KDIGO 2026 Clinical Practice Guideline for Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD) is currently pending final publication following the close of its public comment period in May. The guideline references nafamostat as an acceptable regional anticoagulant during CRRT. This is a positive change from KDIGO's last published AKI guidelines," continued Mr. Angotti. "Separately, our updated market research on CRRT treatment patterns indicates that approximately 200,000 CRRT procedures will be performed in 2027 in the U.S., an increase of 21% over our prior estimate. As we near completion of enrollment, we look forward to hosting an investor event to share these findings and discuss the commercial opportunity for nafamostat, if approved, including the potential favorable implications of the evolving KDIGO guidelines." Second Quarter 2026 and Recent Highlights 75% enrollment in the NEPHRO CRRT clinical study which is expected to be completed this year. Completed our clinical site realignment, with all target clinical sites now activated. KDIGO published its 2026 guideline and completed a public comment period, citing nafamostat as an acceptable CRRT anticoagulation alternative, a positive change from the last published recommendations. KDIGO (Kidney Disease: Improving Global Outcomes) is the global non-profit organization developing and implementing evidence-based clinical practice guidelines in kidney disease. Completed updated market research indicating approximately 200,000 annual U.S. CRRT procedures in 2027, a 21% increase over prior estimates. Regained Nasdaq compliance with the $1 bid price rule. Second Quarter 2026 Financial Information The cash and investments balance was $17.1 million as of June 30, 2026. 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 increase in combined R&D and SG&A expenses in the second quarter of 2026 was primarily due to higher Niyad development expenses, reflecting increased enrollment. Net loss attributable to common shareholders for the second quarter of 2026 was $4.3 million, or $0.06 per basic and diluted share, compared to a net loss of $3.5 million, or $0.10 per basic and diluted share, for the second quarter of 2025. Conference Call and Webcast Talphera will hold a conference call and webcast at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time today to discuss the results and provide an update on the Company's business. Conference Call and Webcast Information Date: Wednesday, August 12, 2026 at 4:30 PM ET/1:30 PM PT Participant Dial-in (North America): 1-800-836-8184 Participant Dial-in (International): 1-646-357-8785 Conference ID: 50873 Webcast Access: Click here The event can also be accessed in the Upcoming Events page in the Investors section of the Talphera website at www.talphera.com. A replay of the webcast will be available on the Talphera website for 90 days after the event. About Talphera, Inc. Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera's lead product candidate, Niyad® is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA). This release is intended for investors only. For additional information about Talphera, please visit www.talphera.com. About Niyad and Nafamostat Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad® is a lyophilized formulation of nafamostat and is currently being studied under an IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. Talphera's registrational study of Niyad is named the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) study. An ICD-10 procedural code, XY0YX37, has been issued for the extracorporeal introduction of nafamostat. The ICD-10 code is a specific/billable code that can be used to indicate a procedure. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that may be investigated and developed for the treatment of acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC), acute pancreatitis or as an anti-viral treatment, amongst other potential targets. About the NEPHRO CRRT Study The NEPHRO CRRT Study is designed as a prospective, double-blinded trial to be conducted at up to 14 U.S. hospital intensive care units. The study will enroll and evaluate 70 adult patients undergoing renal replacement therapy, who cannot tolerate heparin or are at risk for bleeding. The primary endpoint of the study is mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours. Key secondary endpoints include the mean post-filter activated clotting time over 72 hours, filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours. Forward-looking statements This press release contains forward-looking statements based upon Talphera's current expectations and assumptions. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believe", "expect", "anticipate", "may", "if", "intends", "plans", "potential", "projected", "will", or the negative of these words or other comparable terminology, and include: Talphera's expectation the NEPHRO CRRT clinical study will be completed later this year, Talphera's belief that the KDIGO 2026 Clinical Practice Guideline for Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD) has potential favorable implications for the commercial opportunity for nafamostat, Talphera's updated market research on CRRT treatment patterns and its favorable impact on the market opportunity for nafamostat, and Talphera's belief that nafamostat will fill an unmet need in the market as a regional anticoagulant for CRRT. Talphera's discussion of its strategy, plans and intentions also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to Talphera's product development activities, including that clinical studies may not be fully enrolled or completed and/or confirm any safety, efficacy or other potential developmental product characteristics described or assumed in this press release; (ii) Talphera's developmental product candidates may not be beneficial to patients or healthcare providers or be successfully commercialized; (iii) risks relating to Talphera's ability to obtain regulatory approvals for its developmental product candidates; (iv) risks related to the ability of Talphera and its business partners to implement development plans, commercial launch plans, forecasts and other business expectations; and (v) risks related to Talphera's liquidity and its ability to maintain capital resources sufficient to conduct its clinical studies. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption "Risk Factors" and elsewhere in Talphera's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in Talphera's most recent annual, quarterly or current report as filed or furnished with the SEC. Talphera's SEC reports are available at www.talphera.com under the "Investors" tab. Except to the extent required by law, Talphera undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events. View original content to download multimedia:https://www.prnewswire.com/news-releases/talphera-announces-second-quarter-2026-financial-results-and-provides-corporate-update-302850056.html

This article first appeared on GuruFocus. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Talphera Inc (NASDAQ:TLPH) achieved a 50% enrollment milestone in the NEFRO study and has exceeded this level, indicating strong progress. The company is on track to complete enrollment in the NEFRO CRRT study this year and plans to file a PMA for potential approval in 2027. Nine out of twelve activated sites align with the new target site profile, with nephrologists as leads, contributing to over 90% of patient enrollment. The study sites and principal investigators are highly engaged and supportive of the new CRRT anticoagulant. Talphera Inc (NASDAQ:TLPH) has a cash balance of $21.1 million, which, combined with future financing tranches, is expected to support operations through potential NIAID PMA approval next year. Cash operating expenses increased to $3.9 million in Q1 2026 from $2.9 million in Q1 2025, primarily due to higher NIAID development expenses. The company is not planning additional enrollment updates until the study is completed, which may leave investors seeking more frequent updates. Two new study sites are joining late and are not expected to significantly contribute to the study, potentially limiting their impact. The study's completion and data announcement are dependent on the flow of qualifying patients, which could introduce timing uncertainties. The company faces risks and uncertainties related to forward-looking statements, as highlighted in their SEC filings. Warning! GuruFocus has detected 2 Warning Signs with TLPH. Is TLPH fairly valued? Test your thesis with our free DCF calculator. Q: Are you planning to announce enrollment at any other milestone, like 75%, or will the next update be full enrollment? A: (Vince Angadi, CEO) We are not planning any additional enrollment updates until the study is completed. (Rafi Asadorian, CFO) We will announce the last patient out, and the top-line data should follow within a month after that. Q: Is the second half of 2026 still the expected timeline for top-line data release? A: (Vince Angadi, CEO) Yes, we are maintaining our guidance for the second half of 2026 for the top-line data release, depending on the flow of qualifying patients. Q: Can you disclose the new sites coming online and provide any feedback from site administrators? A: (Vince Angadi, CEO) The new sites are significant CRRT population centers but are joining late in the study. (Dr. Shakeel Aslam, CMO) Site administrators have been impressed with the ease of administering the intervention, noting stable test results and minimal variability. Q: How are the sites managing anticoagulation, and what feedback have you received regarding the protocol? A: (Dr. Shakeel Aslam, CMO) Most sites do not use citrate or heparin as standard care but as rescue therapies. The protocol's simplicity and ease of use have been positively received, with nurses appreciating the reduced monitoring requirements. Q: Can you elaborate on the stability of the dosing protocol and its impact on the study? A: (Dr. Shakeel Aslam, CMO) The study uses a predefined starting dose with quick adjustments based on activated clotting time. Nefamostat's metabolism is not organ-dependent, leading to stable responses and minimal dose adjustments. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributed the achievement of the 50% enrollment milestone to protocol changes adopted last year and a shift toward a new target clinical site profile. The strategic pivot to nephrologist-led sites has proven effective, with these locations accounting for over 90% of total patient enrollment to date. Operational progress has unlocked an additional $4.1 million financing tranche, reinforcing the company's capital position for the remainder of the study. Management emphasized that nafamostat's 40-year history of use outside the U.S. is a key driver in attracting high-quality clinical institutions to the NEPHRO study. The company is maximizing its FDA-granted capacity by adding final sites to reach the 14-site limit, primarily to build clinical awareness ahead of potential commercialization. Performance drivers include the simplicity of the study's titration schedule, which management noted has been well-received by clinical staff compared to existing anticoagulants. Talphera expects to complete NEPHRO study enrollment within 2026, with top-line data anticipated approximately one month after the last patient is out. The company plans to file a Premarket Approval (PMA) application following data readout, targeting potential FDA approval of Niyad in 2027. Financial guidance indicates that current cash plus approximately $16 million in remaining conditional tranches should fund operations through the potential PMA approval. The two remaining financing tranches are expected to close concurrently with the announcement of top-line data and study completion later this year. Management's outlook for the second half of 2026 assumes continued steady patient flow, though they acknowledged enrollment can fluctuate in 'ebbs and flows'. Cash operating expenses increased to $3.9 million in Q1 2026, up from $2.9 million year-over-year, primarily driven by higher Niyad development and enrollment costs. The company is utilizing a blinded study design where both placebo and active treatment are administered identically to maintain protocol integrity and ease of use. Management highlighted a competitive advantage in nafamostat's metabolism, which is not dependent on specific organ function, unlike heparin or citrate. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management will not provide a 75% enrollment update as remaining financing tranches are tied only to full study completion. Top-line data is expected within one month of the 'last patient out' due to the short 24-hour primary and 72-hour secondary endpoints. Clinical staff reported high satisfaction with the ease of administration and the lack of variability in test results once a stable dose is reached. Approximately 70% of cases reach the target range at the first starting dose, with nearly all patients stabilized by the end of the first hour. The majority of participating sites do not have a first-line anticoagulant for CRRT, instead using heparin or citrate only as 'rescue' therapies. Only one site currently uses heparin as a standard of care, and no sites use citrate as their primary intervention, highlighting a significant unmet need for a first-line option.

Image source: The Motley Fool. Wednesday, May 13, 2026 at 4:30 p.m. ET Chief Executive Officer — Vincent J. Angotti Chief Financial Officer — Raffi Mark Asadorian Chief Medical Officer — Shakil Aslam Need a quote from a Motley Fool analyst? Email [email protected] Vincent J. Angotti: Thanks, Raffi. Good afternoon. And thank you to everyone joining our call today. it is been less than 2 months since our last update, and we are excited about the progress we have made this year in the nephro study with our ongoing enrollment at current clinical study sites activation of additional sites achievement of the 50% enrollment milestone, and consequently, the closure of an additional financing tranche. With this continued progress, we believe we are well positioned to complete enrollment in the nephro CRRT study this year. and file a PMA for a targeted potential approval of NIAID in 2027. As mentioned, in early March, we announced the attainment of the 50% enrollment milestone in the nephro study. With continued enrollment since that date, I am pleased to report that we have well exceeded this level. The protocol changes we adopted last year supported by bringing on new target profile clinical study sites that position us to achieve our goal of completing the study this year. Building on our virtual investor and analyst event in March, we continue to be genuinely excited about completing this study and submitting our PMA for potential approval of NIAID. The KOLs who participated in our March event highlighted the disadvantages with the currently available anticoagulants they are using. And their belief that Nefamostat will fill an unmet need in this market. These insights as well as our ongoing discussions with other nephrologists, further reinforce our belief that NIAID could have an important role in anticoagulation for CRRT if approved by the FDA. 9 of our 12 activated sites align with the new target site profile that we set last year. And with nephrologists as the lead, these sites have enrolled over 90% of the patients in the study. The quality of our study sites and the principal investigators and their teams is excellent. Dr. Azim and I have been actively visiting many of the sites over the past several weeks and all of them are highly engaged and have expressed their desire to have a new CRRT anticoagulant approved for use. In addition, we look forward to welcoming a couple of additional institutions who have been enthusiastic to participate in the study, allowing us to maximize the 14 sites granted by the FDA. While these new sites will find us further along in enrollment, they have been drawn to the Nephros study by a deep appreciation for Nefamostat's nearly 4 decades of use outside the U.S. and a strong interest in contributing to U.S. research with their peers on a potentially new approved CRRT anticoagulant. Adding these final sites helps lay the groundwork for broader clinical awareness of Nefamostat. Which will serve us well if the FDA approves it next year. With that, I will now hand the call over to Raffi. To update you on the financial results for the first quarter. Raffi Mark Asadorian: Thank you, Vincent. Our cash balance at 03/31/2026, was $21.1 million. We believe this cash, combined with future conditional financing tranches, will provide us sufficient capital through at least a potential NIAID PMA approval expected next year. During the quarter, we closed a $4.1 million financing tranche from the March 2025 private placement. There are 2 remaining conditional financing tranches totaling approximately $16 million of additional capital which, if the conditions are met, are expected to close around the date we release our top line data and announce completion of the study later this year. Our cash operating expenses or combined R&D and SG&A expenses for the 2026 totaled $3.9 million compared to $2.9 million for 2025. Excluding noncash stock based compensation expense, these amounts were $3.7 million for the 2026 compared to $2.7 million for 2025. The increase in cash operating expenses in the 2026 was primarily due to higher NIAID development expenses reflecting increased enrollment and an increase in certain G&A expenses. I will now turn the call back over to Vincent. Vincent J. Angotti: Thank you, Raffi. And I would like to open the line for any questions you might have. Operator? Operator: Thank you. Ladies and gentlemen, we will now begin the Q&A Should you have a question, please press star followed by the 1 on your touch tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, press the star followed by the 2. If you are using a speakerphone, please lift the handset before pressing any key. Your first question comes from the line of James Francis Molloy from Alliance Global Partners. Please go ahead. Analyst (Matt): Hey, guys. Matt on for Jim today. I am just wondering if you guys are going to announce enrollment and any other milestone, maybe 75%, or is the next update going to be full enrollment and then where to expect data quickly after? Thanks. Vincent J. Angotti: Yeah, Raffi, I will start it and then you can give them an idea of the kind of data communication we are planning. So we are not planning on any additional enrollment updates in particular realizing that the balance of the study is not tied to any tranches until the closure of the study. Until the study is being completed. With that said, I think Raffi can communicate to you what our expectation is upon study completion or enrollment completion being last patient out. And how we plan to communicate data thereafter. Raffi Mark Asadorian: Yeah, sure. Yeah, I think we will announce last patient out But the most important is the top line data, which should come within a month after that last patient out. Remember, it is a very quick study, 72 hours at the secondary endpoint, 24-hour primary endpoint. So it is a quick study, and we are cleansing the data along the way. So it will be a quick announcement for that top line top line data. Analyst (Matt): Got it. Thank you. And is there any guidance you can give as to where you might be now or timing going forward, second half 26 still looking like the most likely for a top line read. Vincent J. Angotti: Yeah, the second half of 2026. You know, the study goes in ebbs and flows and so we are going to remain on our guidance for the 2026. Depending on the flow of those qualifying patients moving forward. But we are confident in it being completed this year. And announcing those results this year. Analyst (Matt): Great. Thanks for taking my questions, guys. Vincent J. Angotti: Thanks, Matt. Operator: Your next question comes from the line of Ed Arce from WestPark Capital. Please go ahead. Antonio Eduardo Arce: Hi, Vincent and Raffi. Good to be with you. Congrats on the continued progress. Just a couple of quick questions for me. As we anxiously await full enrollment and top line data later this year. The first 1 is these 2 new sites that you expect to come online pretty soon here, and basically cap out the full complement of sites would you be able to disclose which sites those are or perhaps give a qualitative description of the type of site and the type of patients that they see And then the other question is, have you received any commentary from site administrators that are treating the patients, anyone that is conducting the study, any commentary that you could share with us about how things are progressing? Thanks so much. Vincent J. Angotti: Yeah. I will start with the new sites, Ed. And then I will turn it over to Shakil to give a little more insight on those sites and the site administrators' feedback. The 2 new sites we do not expect to be significant contributors to the study. But they have significant CRRT populations. I say it not to be significant contributors to study because they are coming in so late to the study, but they wanted to be involved moving forward. These are study sites that match our new profile with nephrologists being the lead. 1 of the sites in particular is 1 of the top 5 as far as our data suggests, CRRT-administering hospitals in the country. And we will end up communicating those sites when we update clinicaltrials.gov on the study sites. So you will be able to see who those sites are specifically in conjunction with all the balance of the sites we have to round out the 14. As it relates to the site administrators, and how it is going, I think Shaquille's best positioned to communicate that while he and I have been making our rounds over the last several weeks Remember, it is a blinded study, but I think what is important about this is the placebo and the product are treated similar in the protocol. Shakil Aslam: And the simplicity that comes with it. So, Shakil, Sure. Thanks, Ed. Absolutely. So when we talk to the PIs and the investigators, and then as well as the nurses who are running this study and who are doing testing and looking at some of the test results They are all very, very impressed with the ease of administering this intervention. As Vin said, both placebo as well as NIAID, they are administered exactly the same way. And, sure for the first 24 hours, we have a little bit more intense, monitoring, of blood tests, to see how patients are responding to it. But after 24 hours, you know, that intense goes down. And then they basically all are very, very impressed that how little variability they are seeing in the test results. So that is quite a pleasant surprise to them that they do not have to chase their tails trying to keep some, you know, the parameters within target range. Once they have somebody stable, at a parameter, lab parameter, they basically stay the same value. So overall, I think Thank you. Everybody is yeah. Vincent J. Angotti: Shakil, could you comment on the reach or the conclusion of that stability to get to the proper dose in that first hour? And why that protocol works for them. And how we are basically controlling that primary endpoint on that first hour. Shakil Aslam: Right. So as you know, in this study, we start at a starting dose, which is predefined. And 15 minutes later, we check the activated clotting time by a handheld device by the bedside, which we provide, and we provide the cartridges as well. So it is pretty standardized test across all sites. And within 15 minutes, they check the value and we have a certain range in which we want that value to be. So about 70% of, the cases, you see the ACT going in that range right, at the first starting dose. Occasionally, a patient, less than 25%, may need 1 and a couple of them may have needed even more than 1 titration, 2 titrations. Which is by the end of the first hour, everybody is in the range. In which they are expected to be. Obviously, you know, I am not going to disclose for different groups because there is 1 placebo in which we expect the value to change much but has expected their value to change. In active treatment, the value changes, but they remain within that range. So this it is a very, very stable response. Which is not a total surprise to us because Nefamostat's metabolism is really not dependent on any specific organ. So there are other drugs which are dependent on liver or kidneys or any other organ for metabolism. And every time the function of those organs deteriorates, or changes, you can see different response. And the whatever parameter you are following. Whereas, Nefamostat, it really is not dependent on any organ. Most of these patients, they can have fluctuating organ function. Can affect other medications such as heparin being 1 example. Citrate is another example. If you have liver failure, citrate will not be metabolized as quickly. Nefamostat does not have those issues. So that is the reason why once you hit the target level, it essentially remains stable. Does that answer your question? Antonio Eduardo Arce: Yeah, yeah, sure. Yeah, that is--I could add a little Thank you. Vincent J. Angotti: Shakil, a little bit more color. So on the administrative side, can you comment to the people on the line how many of the sites are typically using citrate as a primary intervention for anticoagulation and CRRT, and/or heparin as a primary intervention both anticoagulation and CRT. Shakil Aslam: Sure. So of the 12 sites that we have we do not have any site that uses citrate. As a standard of care. So there are 2 or 3 sites that will use citrate. Only if a patient continues to clot. And these sites do not use heparin at all, so the sites that are using citrate, they do not use heparin. So they do, 3 sites that have access to citrate. They are not citrate first users, only use citrate as a--as citrate is the only rescue they have. We have 2 sites, only 1 site that uses heparin as standard of care of all the sites that we have. Then we have 2 or 3 sites that use heparin as a rescue therapy. So they do not use either citrate or heparin, when the CRRT started. But if they see clotting, they do not have access to citrate, so then they go back to rescue heparin. Majority of our sites right now, I would say, you know, 10 out of 12 or 13 that we have, they really do not have any first-line anticoagulant that they use for every single patient. They are really using, either heparin or citrate as a rescue. And we do not have any site that uses citrate for everybody. Vincent J. Angotti: And I think, importantly, Ed, when they execute the protocol in the nephro study, and the titration schedule, they see the ease of use, whether it is placebo or active does not matter. Placebo or active does not matter. it is just the ease of that titration schedule compared to what their historic challenges have been with heparin and citrate, and that seems to be the additional feedback. Shakil Aslam: Simplicity, right, is the main comment. Right. And nurses, even we spoke visiting a site today and the nurses were like shocked, "Okay, we do not have to do anything else. No. that is it. that is all the monitoring that is required. Antonio Eduardo Arce: So that is very helpful. Thank you both. Shakil Aslam: Sure. Operator: Thank you. There are no further questions at this time. I will now turn the call over to Vincent. Please continue. Vincent J. Angotti: Thank you, operator. And I will just clarify my comment I said earlier about the site names, the additional 2 that will be coming on that will be on clinicaltrials.gov. Excuse me. And our next update of those sites. So again, thank you all for joining us on our first quarter earnings call. We are really very high on what is happening at the 2026 and the enrollment that is continuing to move forward. The NEPHRO study progress has been excellent. Our commitment, enthusiasm, to bring the potentially new regional anticoagulant for CRRT to the market next year is unwavering. So we appreciate your attendance today. And we are very excited about the future for the nephro study as well as Talphera moving forward. We will provide you additional updates on our progress, and thank you for joining us on the call Operator, that concludes our call. Operator: Thank you very much. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. Before you buy stock in Talphera, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Talphera wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Talphera (TLPH) Q1 2026 Earnings Transcript was originally published by The Motley Fool

NEPHRO CRRT clinical study expected to be completed this year Cash and investments of $21.1 million at March 31, 2026 Conference call and webcast to be held on Wednesday, May 13, 2026 at 4:30 pm ET SAN MATEO, Calif., May 13, 2026 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced first quarter 2026 financial results and provided a corporate update. "In early March, we announced the attainment of 50% enrollment in the NEPHRO CRRT study evaluating nafamostat. With continued steady enrollment, we have well exceeded this level, and continue to expect study completion later this year," stated Vince Angotti, CEO of Talphera. "Our clinical study sites and principal investigators remain focused on enrollment and delivering a high quality study as they are eager for a potential alternative anticoagulant for Continuous Renal Replacement Therapy (CRRT). The investor and analyst event held in March also highlighted the need for an alternative, given the disadvantages of the currently used products, heparin and citrate. If approved, we continue to believe nafamostat will fill an unmet need in the market as a regional anticoagulant for CRRT," continued Angotti. First Quarter 2026 and Recent Highlights In March 2026, announced reaching the 35-patient enrollment milestone, representing 50% enrollment in the NEPHRO CRRT study. Enrollment has continued to increase since this announcement, with study completion expected in 2026. In March 2026, held an investor and analyst event with two key opinion leaders (KOLs) focused on anticoagulants used during CRRT and the potential for nafamostat to address an unmet need. In March 2026, two posters were presented at the 31st Annual International Conference on Advances in Critical Care Nephrology (AKI & CRRT 2026), entitled: "A Randomized, Placebo-Controlled Multi-Center Study of the Safety and Efficacy of Niyad in Patients Undergoing Continuous Renal Replacement Therapy Who Cannot Tolerate Heparin or Are at a Higher Risk of Bleeding" and, "In Vivo Assessment of Nafamostat, A Novel Regional Anticoagulant in a Porcine Model AKI and CKRT". In March 2026, closed $4.1 million third tranche of the March 2025 private placement financing upon achieving the 35-patient enrollment milestone and other conditions. First Quarter 2026 Financial Information The cash and investments balance was $21.1 million as of March 31, 2026. Combined R&D and SG&A expenses for the first quarter of 2026 totaled $3.9 million compared to $2.9 million for the first quarter of 2025. Excluding non-cash stock-based compensation expense, these amounts were $3.7 million for the first quarter of 2026, compared to $2.7 million for the first quarter of 2025. The increase in combined R&D and SG&A expenses in the first quarter of 2026 was primarily due to higher Niyad® development expenses, reflecting increased enrollment, and an increase in certain G&A expenses. Net loss attributable to common shareholders for the first quarter of 2026 was $2.6 million, or $0.04 per basic and diluted share, compared to a net loss of $2.6 million, or $0.10 per basic and diluted share, for the first quarter of 2025. Conference Call and Webcast Talphera will hold a conference call and webcast at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time today to discuss the results and provide an update on the Company's business. Investors who wish to participate in the conference call may do so by dialing 1-800-836-8184 for North American callers, or 1-646-357-8785 (toll applies) for international callers outside of Canada. The conference ID is 24180. The webcast can be accessed here or by visiting the Investors section of the Company's website at www.talphera.com and clicking on the webcast link posted within Investors/News & Events/Upcoming Events section. The webcast will include a slide presentation and a replay will be available on the Talphera website for 90 days following the event. About Talphera, Inc. Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera's lead product candidate, Niyad® is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA). This release is intended for investors only. For additional information about Talphera, please visit www.talphera.com. About Niyad and Nafamostat Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad® is a lyophilized formulation of nafamostat and is currently being studied under an IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. Talphera's registrational study of Niyad is named the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) study. An ICD-10 procedural code, XY0YX37, has been issued for the extracorporeal introduction of nafamostat. The ICD-10 code is a specific/billable code that can be used to indicate a procedure. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that may be investigated and developed for the treatment of acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC), acute pancreatitis or as an anti-viral treatment, amongst other potential targets. About the NEPHRO CRRT Study The NEPHRO CRRT Study is designed as a prospective, double-blinded trial to be conducted at up to 14 U.S. hospital intensive care units. The study will enroll and evaluate 70 adult patients undergoing renal replacement therapy, who cannot tolerate heparin or are at risk for bleeding. The primary endpoint of the study is mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours. Key secondary endpoints include the mean post-filter activated clotting time over 72 hours, filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours. Forward-looking statements This press release contains forward-looking statements based upon Talphera's current expectations and assumptions. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believe," "expect," "anticipate," "may," "if," "intends," "plans," "potential," "projected," "will," or the negative of these words or other comparable terminology, and include: Talphera's expectation the NEPHRO CRRT clinical study will be completed later this year, and Talphera's belief that nafamostat will fill an unmet need in the market as a regional anticoagulant for CRRT. Talphera's discussion of its strategy, plans and intentions also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to Talphera's product development activities, including that clinical studies may not be fully enrolled or completed and/or confirm any safety, efficacy or other potential developmental product characteristics described or assumed in this press release; (ii) Talphera's developmental product candidates may not be beneficial to patients or healthcare providers or be successfully commercialized; (iii) risks relating to Talphera's ability to obtain regulatory approvals for its developmental product candidates; (iv) risks related to the ability of Talphera and its business partners to implement development plans, commercial launch plans, forecasts and other business expectations; and (v) risks related to Talphera's liquidity and its ability to maintain capital resources sufficient to conduct its clinical studies. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption "Risk Factors" and elsewhere in Talphera's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in Talphera's most recent annual, quarterly or current report as filed or furnished with the SEC. Talphera's SEC reports are available at www.talphera.com under the "Investors" tab. Except to the extent required by law, Talphera undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.         View original content to download multimedia:https://www.prnewswire.com/news-releases/talphera-announces-first-quarter-2026-financial-results-and-provides-corporate-update-302769923.html