Talphera Q1 2026 Earnings Call - Niyad NEPHRO Study Exceeds 50% Enrollment Milestone, PMA Targeted for 2027

Conference Call Operator, Talphera: Welcome to the Talphera First 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. Please go ahead.

Raffi Asadorian, Chief Financial Officer, Talphera: Thank you, and thank you for joining us on the call today. Today, we announced our first 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 discussion of the risks associated with such forward-looking statements. These documents can also be found on the website within the Investors section. I’ll now hand the call over to Vince.

Vince Angotti, Chief Executive Officer, Talphera: Thanks, Raffi. Good afternoon, thank you to everyone joining our call today. It’s been less than 2 months since our last update, and we’re excited about the progress we’ve 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 the PMA for a targeted potential approval of Niyad 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’m 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, have positioned 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 Niyad. The KOLs who participated in our March event highlighted the disadvantages with the currently available anticoagulants they’re using and their belief that nafamostat will fill an unmet need in this market. These insights, as well as our ongoing discussions with other nephrologists, further reinforce our belief that Niyad 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.

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. Aslam and I have been actively visiting many of the sites over the past several weeks, 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’ve 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’ve been drawn to the NEPHRO study by a deep appreciation for nafamostat’s nearly 4 decades of use outside the U.S. and a strong interest in contributing to the 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 nafamostat, which will serve us well if the FDA approves it next year. With that, I’ll now hand the call over to Raffi to update you on the financial results for the first quarter.

Raffi Asadorian, Chief Financial Officer, Talphera: Thank you, Vince. Our cash balance at March 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 Niyad 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 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 cash operating 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. I’ll now turn the call back over to Vince.

Vince Angotti, Chief Executive Officer, Talphera: Thank you, Raffi. I’d like to open the line for any questions you might have. Operator?

Conference Call Operator, Talphera: Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. 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 keys. One moment please for your first question. Your first question comes from the line of James Molloy from Alliance Global Partners. Please go ahead.

Matt (on behalf of James Molloy), Analyst, Alliance Global Partners: Hey, guys. Matt on for Jim today. I was just wondering if you guys are going to announce enrollment at any other milestone, maybe 75%, or is the next update going to be full enrollment and then we’re to expect data quickly after? Thanks.

Vince Angotti, Chief Executive Officer, Talphera: Yeah, Raffi, I’ll start it and then you can give them an idea of kind of the data communication we’re planning. We’re not planning on any additional enrollment updates, in particular realizing that the balance of the study isn’t 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 Asadorian, Chief Financial Officer, Talphera: We’ll announce last patient out, but the most important is the top-line data, which should come, you know, within a month after that last patient out. Remember, it’s a very quick study, 72 hours at the secondary endpoint, 24-hour primary endpoint. It’s a quick study, and we’re cleansing the data along the way. It’ll be a quick announcement for that top-line data.

Matt (on behalf of James Molloy), Analyst, Alliance Global Partners: Got it. Thank you. Is there any guidance you can give as to where you might be now or timing going forward? Second half 2026 still looking like the most likely for a top-line read?

Vince Angotti, Chief Executive Officer, Talphera: The second half of 2026. You know, the study goes in ebbs and flows. We’re gonna remain on our guidance for the second half of 2026, depending on the flow of those qualifying patients moving forward. We’re confident in it being completed this year and announcing those results this year.

Matt (on behalf of James Molloy), Analyst, Alliance Global Partners: Great. Thanks for taking my questions, guys.

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

Conference Call Operator, Talphera: Thank you. Your next question comes from the line of Ed Arce from WestPark Capital. Please go ahead.

Ed Arce, Analyst, WestPark Capital: Hi, Vince, Rafi. 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 one 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? 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.

Vince Angotti, Chief Executive Officer, Talphera: I’ll start with the new sites, Ed, and then I’ll turn it over to Shakil to give a little more insight on those sites and the site administrators’ feedback. The 2 new sites we don’t expect to be significant contributors to the study, but they have significant CRRT populations. I say it not to be significant contributors to the study because they’re 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. We’ll end up communicating those sites when we update clinicaltrials.gov, dot com on the study sites.

You’ll 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’s going, I think Shakil’s best positioned to communicate that while he and I have been making our rounds over the last several weeks. Remember, it’s a blinded study, but I think what’s important about this is the placebo and the product are treated similar in the protocol and the simplicity that comes with it. Shakil.

Dr. Shakil Aslam, Chief Medical Officer, Talphera: Sure. Thanks, Ed. Absolutely. 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 Vince said, both placebo as well as Niyad, they are administered exactly the same way. Sure, for first 24 hours we have little bit more intense monitoring or blood test to see how patients are responding to it. After 24 hours, you know, that intensity goes down and they basically all are very, very impressed at how little variability they are seeing in the test results.

That’s quite a pleasant surprise to them that they don’t have to chase their tails trying to keep some, you know, the parameters in within a target range. Once they have somebody stable, at a parameter, lab parameter, they basically stays the same value. Overall, I think.

Vince Angotti, Chief Executive Officer, Talphera: Shakeel

Dr. Shakil Aslam, Chief Medical Officer, Talphera: Everybody is. Yeah. Yeah. Sorry.

Vince Angotti, Chief Executive Officer, Talphera: Shakil, can 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? How we’re basically controlling that primary endpoint on that first hour?

Dr. Shakil Aslam, Chief Medical Officer, Talphera: Right. As you know, 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. It’s pretty standardized test across all sites. Within 15 minutes to check the value and we have a certain range in which we want that value to be. About 70% of the cases, you see the ACT going in that range, right, at the first starting dose.

Occasionally, a patient, that’s 25% may need one, and a couple of them may have needed even more than one titration, two titrations, which is, by the end of 1st hour, everybody is in the range in which they are expected to be. Obviously, you know, I’m not gonna disclose for different groups because there’s one placebo in which we don’t expect the value to change much. As expected, their value doesn’t change. In active treatment, the value changes, they remain within that range. This, it’s a very, very stable response and which is, which is not a total surprise to us because nafamostat’s metabolism is really not dependent on any specific organ. There are other drugs which either depend on liver or kidneys or any other organ for metabolism.

Every time the function of those organs deteriorates or changes, you can see different response, in whatever parameter you’re following. The beauty about nafamostat, it really is not dependent on any organ. Most of these patients, they can have fluctuating organ function, which can affect other medications, such as heparin being one example. Citrate is another example. If you have liver failure, citrate will not be metabolized as quickly. Nafamostat doesn’t have those issues. That’s the reason why once you hit the target level, it essentially remains stable. Does that answer your question?

Vince Angotti, Chief Executive Officer, Talphera: Shakil, can I ask you.

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

Vince Angotti, Chief Executive Officer, Talphera: Yeah, that’s.

Dr. Shakil Aslam, Chief Medical Officer, Talphera: If you could add a little color.

Vince Angotti, Chief Executive Officer, Talphera: That’s enough. Thank you. Shakil, a little bit more color. On the administrator site, 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?

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

Vince Angotti, Chief Executive Officer, Talphera: Anticoagulation and CRRT.

Dr. Shakil Aslam, Chief Medical Officer, Talphera: Sure. Of the 12 sites that we have, we don’t have any site that uses citrate as a standard of care. There are 2 or 3 sites that will use citrate only if a patient continues to clot. These sites do not use heparin at all. The sites that are using citrate, they don’t believe in heparin. They, 2 or 3 sites that have access to citrate, they are not citrate first users, only use citrate as a rescue, 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. We have 2 or 3 sites that use heparin as a rescue therapy.

They don’t use either citrate or heparin when the CRRT is started. If they see clotting, they don’t have access to citrate. 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 don’t really have any first-line anticoagulant that they use for every single patient. They are really using either heparin or citrate as a rescue. We don’t have any site that uses citrate for everybody.

Vince Angotti, Chief Executive Officer, Talphera: 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’s placebo or control, doesn’t matter. Placebo or active, doesn’t matter. It’s just the ease of that titration schedule compared to what their historic challenges have been with heparin and citrate. That seems to be the additional feedback.

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

Vince Angotti, Chief Executive Officer, Talphera: is the main comment.

Dr. Shakil Aslam, Chief Medical Officer, Talphera: Right. The nurses, even we spoke visiting a site today and the nurses, they were like shocked. "Okay, we don’t have to do anything else?" "No, that’s it. You know, that’s all the monitoring that’s required." Yeah.

Ed Arce, Analyst, WestPark Capital: That’s very helpful. Thank you both.

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

Conference Call Operator, Talphera: Thank you. There are no further questions at this time. I will now turn the call over to Vince. Please continue.

Vince Angotti, Chief Executive Officer, Talphera: Thank you, operator. I’ll 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. Clinicaltrials.gov, excuse me. In our next update of those sites. Again, thank you all for joining us on our first quarter earnings call. We’re really very high on what’s happening at the start of 2026 and the enrollment that’s 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. We appreciate your attendance today, and we’re very excited about the future for the NEPHRO study, as well as Talphera moving forward. We’ll provide you additional updates on our progress and thank you for joining us on the call today.

Operator, that concludes our call.

Conference Call Operator, Talphera: Thank you very much. Ladies and gentlemen, this concludes today’s conference call. Thank you for your participation. You may now disconnect.