Talphera Inc (TLPH) 2025 Q3 法說會逐字稿

Welcome to the Talphera third quarter 2025 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.

Thank you for joining us on the call today. Today, we announced our third quarter 2025 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 Securities and Exchange Commission 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.

Thanks, Raffi. Good afternoon, and thank you to everyone joining our call today. We're excited about the progress made this past quarter, specifically in the continued NEPHRO study enrollment at our current clinical study sites and completing a financing that, with the additional tranches provides us sufficient capital to a planned approval of the Niyad PMA later next year.

In September, we completed the first closing of $17 million of a 2-tranche financing, which included CorMedix with a $5 million strategic minority investment that provides them a 60-day exclusive negotiation period to enter into a definitive acquisition agreement following the release of our top-line data from the NEPHRO study.

CorMedix was also provided the right to a Talphera Board seat to which Joe Todisco, CorMedix's CEO, was recently appointed. In addition to the CorMedix strategic investment in the first tranche, existing financial investors, Nantahala, Rosalind, and Rock Springs Capital, along with some new institutional investors, invested $12 million to complete the $17 million financing.

Importantly, these institutional investors committed an additional $12 million in a second tranche upon announcement of achieving the NPR study primary endpoint and a stock price trading above $0.69 per share for five consecutive days post the announcement. This latest financing, combined with existing cash and the remaining conditional tranches, is expected to provide sufficient capital through at least an anticipated PMA approval in late 2026.

These investments further validate the Niyad opportunity in the market and put us in a solid financial position to execute on the study and prepare for the launch. Beyond the Niyad opportunity, the recent investments were catalyzed by our efforts at the end of last year to restructure the NEPHRO clinical study, which included changing the target profile for clinical sites and investigators and approaching the FDA with various study protocol changes, including the reduction of the study size from 166 to 70 patients with a goal of accelerating the completion of the study.

The results of this restructuring were evident last quarter with the acceleration in the enrollment rate from our existing sites, which continued into the third quarter.

The three new profile institutions that were brought on board earlier this year have demonstrated the speed of enrollment that is possible when focusing on medical ICUs and having nephrologists as the principal investigators.

We expect continued positive enrollment rates from these institutions, and we'll provide an update once we achieve 35 patients or 50% study enrollment. While the enrollment rate from our three existing target profile sites has remained robust, the initiation of the six additional target profile sites expected by the end of the third quarter has been slower than anticipated.

As of today, we've successfully activated two of the six new target sites, each of which is expected to be high enrolling. The remaining four target sites, including one of the highest volume CRRT institutions in the country, are under contract, but for a variety of unique reasons to their respective institutions have not yet started their enrollment. Because of the delays on the new site's activation, we've pushed the estimated timing of study enrollment completion to the first half of next year.

Dr. Aslam will provide some details on the specific reasons for the delayed activation, as well as his thoughts and assumptions on the timing of study completion. In addition, Dr. Aslam and I have continued to visit with many of the new study teams at their respective sites. While observing their study engagement, I'm also highly encouraged by the eagerness of these institutions to have nafamostat available. In their words, nafamostat, based on its profile and use in other countries, would be a preferred anticoagulant for CRRT.

And while we need to complete the study, this feedback from these investigators continues to strengthen my belief that nafamostat, if approved, will become a primary product in the market for CRRT anticoagulation.

Now before I turn the call over to Dr. Aslam to provide some additional details, let me remind you that if approved, Niyad would become the only FDA-approved regional anticoagulant for use during continuous renal replacement therapy. This is important and that there are many disadvantages to the currently used products, heparin, which is systemic in nature, and citrate, which is being used off-label.

I'll now hand the call over to Dr. Aslam.

Thank you, Vince. Similar to what we discussed last quarter, the enrollment rate at our existing target profile sites continues to impress and validate that the changes we made to the NEPHRO study were the right moves to accelerate enrollment.

We are confident these sites will achieve enrollment to complete the study in a timely manner once the remaining four sites with our target profile begin enrolling. Because of the short duration of the study, we have been successful in real-time data cleaning to minimize any delays in locking the database once the enrollment is completed.

The guidance previously provided for study completion by the end of 2025 was contingent upon adding six new target profile sites by September 30 to the existing three target profile sites that were already exceeding the historical enrollment rate. Importantly, these six new sites are all large academic institutions, and most have higher CRRT volumes than the legacy sites.

As of today, we have activated two of these six sites, with the remaining four sites to be activated during this quarter. We knew two of these four sites were going to be slow to activate. However, due to their large CRT volumes and their status as prominent institutions, we welcomed their participation.

These two sites have already completed contracting. One is waiting for the final internal approval, expected any day now. The other is in the process of scheduling its site initiation visit with activation expected next month.

The remaining two sites changed their approval processes after contracting was completed, resulting in delays past their original timelines for activation. One had an institution-wide restructuring resulting in unexpected delays in the final approval. They have assured us the final approval next month.

The final institution is having their site initiation visit next week, followed by activation, as no additional approvals are required. Due to the delays in the activation of these new sites, we now anticipate study completion in the first half of 2026.

While we are disappointed by the delays in the activation of these sites, we remain confident that these high-quality sites will significantly contribute to the study as well as the potential future utilization of Niyad. All of these institutions are anticipated to have similar or even higher enrollment rates than our initial three target profile sites. The [PIs] are excited to start enrolling and are expected to make a significant contribution to the study.

In our continuous efforts to improve study enrollment, we reviewed the emerging screening data to optimize the study design. Based on this review, we have submitted further changes to the study eligibility criteria, which we expect will accelerate the enrollment rate and broaden the target patient population for Niyad. We expect to hear from the FDA in a couple of weeks.

As we mentioned on our last call, we continue to advance our compassionate use IDE with a large institute in the Southeast for a subset of specific patients with contraindications to currently available anticoagulants. This opportunity to provide -- this is an opportunity to provide an alternative to these patients who cannot receive the currently available anticoagulants and, as a result, clock their CRT circuits frequently.

This is the first compassionate use submission by this institution, and we are helping them work through the process as quickly as possible. We will provide more information on the compassionate use IDE when submitted.

And with that, I'll turn the call back over to Vince.

Thank you, Dr. Aslam. Before I hand the call over to Raffi, I want to reiterate our belief that the three critical risk elements, clinical, regulatory, and commercial for the nafamostat program are low for a number of reasons.

First, with over 30 years of use as an anticoagulant during CRRT in Japan and South Korea, we know nafamostat's track record of efficacy and safety, minimizing the clinical risk. The trial design has been agreed with the FDA, including broader inclusion criteria and a reduced number of patients, all of which have helped minimize study execution risk and proven to increase enrollment rates.

Second, we have a clear regulatory path, including breakthrough designation from the FDA, which has provided us with efficient access to the agency, leading to quick review and response times. And lastly, while we know there's always commercial risk, we believe this is mitigated given the disadvantages of the products currently being used for anticoagulation of the CRRT circuit, namely heparin and citrate.

Based on all our discussions we're having with healthcare providers, there's a clear need for an FDA-approved regional anticoagulant.

I'll now hand the call over to Raffi for a financial update.

Thanks, Vince. Our cash balance at September 30, 2025, was $21.3 million. We believe this cash, combined with the future conditional financing tranches will provide us sufficient capital through at least a Niyad PMA approval expected next year.

Our cash operating expenses, or combined R&D and SG&A expenses for the third quarter of 2025, totaled $3.4 million compared to $3.7 million for the third quarter of 2024. Excluding noncash stock-based compensation expense, these amounts were $3.3 million for the third quarter of 2025 compared to $3.5 million for the third quarter of 2024.

The decrease in cash operating expenses in the third quarter of 2025 was primarily due to reductions in personnel expense and other SG&A expenses. As mentioned, due to delays on the activation of the new clinical sites, we've revised the estimated timing of NEPHRO study completion to the first half of next year.

Accordingly, we are reducing the previously communicated 2025 expected cash operating expense guidance to now be in the range of $14 million to $15 million. This is a reduction from the $16 million to $17 million range provided last quarter. with the difference expected to be realized in the first half of 2026.

I'll now turn the call back to Vince.

Thank you, Raffi. Now I'd like to open the line for any questions you might have. Operator?

(Operator Instructions)

Naz Rahman, Maxim Group.

Hi everyone, thanks for taking my questions. I just have a couple. First, I just want to start on the enrollment. The new sites -- the new target sites that have already been activated, are you finding that they're enrolling patients faster? Or I guess, have the rates of patient enrollment increased? Because the last time -- when you last communicated the 17 patients, that was in August, and you still don't have the 35 patients.

So it seems like mathematically, you're enrolling less than two patients a week. So I'm kind of left wondering why aren't the sites enrolling faster, the ones that have already been activated.

Yeah. No, the original sites that we communicated last time, there were three of them, three of them only. And they hadn't enrolled the original five patients, right? Only when you put those three additional sites on did you see the movement from the five patients to the 17, and we're beyond the 17 now. So we're seeing a fairly similar rate of enrollment that we had seen before, similar rate of consents, enrollment, screening, et cetera.

So we're well beyond that 17. But in order for us to achieve an accelerated enrollment, we need to layer on these additional sites.

No, what I'm asking is the new target sites, are you finding that they're enrolling patients faster now that they have some experience? Or are they still enrolling around the same rate?

Yeah, they're enrolling about the same rate.

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

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

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

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

Got it.

Thank you for taking my questions.

Thanks, Naz.

(Operator Instructions) And there are no further questions at this time. I will now hand the call back to Vincent Angotti for any closing remarks.

Thank you, operator. And again, thank you for joining our third-quarter earnings call. We're excited about the progress we've made with the recent financing, increased enrollment, and continued quality of the additional new sites to allow us to complete the NEPHRO study in the first half of '26 and achieve a potential FDA approval of Niyad in late 2026.

We hope you appreciate our transparency and site activation, and continuous efforts to improve the study execution. We look forward to providing additional updates on our progress, and thank you for your interest in Talphera. That concludes our call.

This concludes today's call. Thank you for participating. You may all disconnect.