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DATE
Wednesday, November 12, 2025 at 4:30 p.m. ET
CALL PARTICIPANTS
- Chief Executive Officer — Vincent J. Angotti
- Chief Medical Officer — Shakil Aslam
- Chief Financial Officer — Raffi Asadorian
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RISKS
- Study Enrollment Delays — Management revised projected enrollment completion to the first half of 2026, citing "delays in the activation of the new sites," compared to prior year-end 2025 expectations.
- Site Activation Challenges — Dr. Aslam stated that some large new target profile sites experienced "unexpected delays," particularly from institution-wide restructuring and internal approval process changes.
- Compassionate Use IDE Progress — The company noted that a compassionate use IDE submission is "the first" for the institution involved and is not finalized, which may introduce uncertainty in timing for additional patient access initiatives.
TAKEAWAYS
- Cash Balance -- $21.3 million as of September 30, 2025, with management stating this, plus conditional financing tranches, is expected to fund operations through at least an anticipated NIAID PMA approval in late 2026.
- Recent Financing -- A $17 million two-tranche deal was executed in September; CorMedix (NASDAQ: CRMD) invested $5 million and received a 60-day exclusive negotiation period for a potential acquisition, following nephro study topline data release.
- Additional Financing Commitments -- Institutional investors committed another $12 million in a second tranche, pending achievement of nephro study primary endpoint and a share price above $0.69 for five consecutive days post-announcement.
- Cash Operating Expenses -- $3.4 million for 2025, down from $3.7 million in 2024, primarily due to lower personnel and SG&A costs.
- Cash Operating Expenses Excluding Stock-Based Compensation -- $3.3 million in 2025 versus $3.5 million in 2024; the decrease in 2025 was primarily due to reductions in personnel expense and other SG&A expenses.
- Revised Cash Expense Guidance -- 2025 expected cash operating expenses lowered to $14 million-$15 million, down from the previous $16 million-$17 million due to study timeline revisions.
- Nephro Study Site Status -- Three target profile enrollment sites continued strong performance; two of six new sites activated, four under contract but delayed, with all anticipated to be high-enrolling academic institutions.
- Enrollment Rate -- "enrollment rate from our three existing target profile sites has remained robust," but addition of new high-volume sites is necessary for acceleration.
- Study Completion Timing -- Management now expects nephro study completion in 2026, compared to previous guidance of year-end 2025.
- FDA Protocol Changes -- A protocol amendment is pending with the FDA to broaden eligibility criteria, which management expects will accelerate enrollment and broaden NIAID’s target population.
- NIAID Positioning -- "If approved, NIAID would become the only FDA-approved regional anticoagulant for use during continuous renal replacement therapy," highlighting a unique commercial opportunity.
- Strategic Investment Terms -- CorMedix (NASDAQ: CRMD) received a Talphera (NASDAQ: TLPH) board seat, now held by CEO Joe Todisco, as part of the financing deal.
- Compassionate Use IDE -- The company is advancing a compassionate use IDE for patients unable to tolerate standard anticoagulants, with additional details to come when submitted.
- Regulatory Status -- Management cited FDA breakthrough designation and agreed-upon trial design as drivers for expedited NIAID review and regulatory clarity.
SUMMARY
Management shifted its projected completion timelines for the nephro study to 2026 due to slow activation at four high-volume academic sites. The company secured $17 million in fresh financing and outlined a further $12 million in conditional capital, contingent on specific clinical and share price milestones. Year-over-year operating expenses fell, with expense guidance revised downward for 2025 in light of study delays. CorMedix's strategic investment included board representation and acquisition negotiation rights following nephro study topline data. The pending FDA protocol amendment may broaden patient eligibility and impact future enrollment acceleration.
- CEO Angotti said, "elements—clinical, regulatory, and commercial—for the Nefamostat program are low," citing clinical safety record, FDA-agreed trial design, and the lack of FDA-approved alternatives.
- Dr. Aslam noted, "All of these institutions are anticipated to have similar or even higher enrollment rates than our initial three target profile sites."
- Only the Veterans Affairs Medical Center site experienced federal staffing-related approval delays, impacting start times by an estimated three to four months, but not affecting currently enrolling sites.
INDUSTRY GLOSSARY
- CRRT (Continuous Renal Replacement Therapy): A form of dialysis used for critically ill patients that continuously removes waste and fluid over 24 hours in intensive care settings.
- PMA (Premarket Approval): The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
- IDE (Investigational Device Exemption): FDA authorization allowing an investigational device to be used in a clinical study to collect safety and effectiveness data.
- SG&A (Selling, General, and Administrative Expenses): The expenses associated with selling products and managing the business, excluding R&D and production costs.
Full Conference Call Transcript
Vincent J. Angotti: Thanks, Raffi. Good afternoon, and thank you to everyone joining our call today. We are excited about the progress made this past quarter, specifically in the continued nephro study enrollment at our current clinical study sites and completing the financing that, with the additional tranches, provides us sufficient capital to a planned approval of the NIAID PMA later next year. In September, we completed the first closing of $17 million of a two-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, Inc. board seat, to which Joe Todisco, CorMedix's CEO, was recently appointed. In addition to the CorMedix strategic investment in the first tranche, 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 nephro 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 NIAID opportunity in the market and put us in a solid financial position to execute on the study and prepare for the launch. Beyond the NIAID 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 in focusing on medical ICUs and having nephrologists as the principal investigators. We expect continued positive enrollment rates from these institutions and will 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 have 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 have pushed the estimated timing of study enrollment completion to the first half of next year. Doctor 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, Doctor Aslam and I have continued to visit with many of the new study teams at their respective sites.
While observing their study engagement, I am also highly encouraged by the eagerness of these institutions to have Nefamistat available. In their words, Nefamostat, 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 Nefamostat, if approved, will become a primary product in the market for CRRT anticoagulation. Before I turn the call over to Doctor Aslam to provide some additional details, let me remind you that if approved, NIAID would become the only FDA-approved regional anticoagulant for use during continuous renal replacement therapy.
This is important in 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 Doctor Aslam.
Shakil 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.
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 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 CRRT 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 of 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 the new sites, we now anticipate study completion in 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 NIAID. 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 NIAID. 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 is an opportunity to provide an alternative to these patients who cannot receive the currently available anticoagulants. As a result, they clot their CRRT 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.
Vincent J. Angotti: Thank you, Doctor 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 Nefamostat program are low for a number of reasons. First, with over thirty years of use as an anticoagulant during CRRT in Japan and South Korea, we know Nefamostat'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, improving to increase enrollment rates.
Second, we have a clear regulatory path, including breakthrough designation from the FDA, which 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.
Raffi Asadorian: 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 to at least a NIAID PMA approval expected next year. Our cash operating expenses, or combined R&D and SG&A expenses for 2025, totaled $3.4 million compared to $3.7 million for 2024. Excluding non-cash stock-based compensation expense, these amounts were $3.3 million for 2025 compared to $3.5 million for 2024. The decrease in cash operating expenses in 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 2026. I'll now turn the call back to Vince.
Vincent J. Angotti: Thank you, Raffi. Now I'd like to open the line for any questions you might have. Operator?
Operator: Ladies and gentlemen, we will now begin the question and answer session. As a reminder, should you have a question, please press 451 on your telephone keypad. And should you wish to cancel your request, please press 452. One moment, please, for your first question. And your first question comes from the line of Nazibur Rahman from Maxim Group. Please go ahead.
Nazibur Rahman: Hi, everyone. Thanks for taking my questions. I just have a couple. First, just want to start on the enrollment. 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?
Vincent J. Angotti: 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, etcetera. 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.
Nazibur Rahman: No, but 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?
Vincent J. Angotti: Yeah. They're enrolling about the same rate.
Nazibur Rahman: Got it. And, one more question, if I may. I know you're talking about these new target sites and these 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 all academic institutions. Has that kind of played in or had any factor in any of these organizations? Their ability to conduct clinical study, whether staffing or other leadership or structural issues, has that affected anything?
Vincent J. Angotti: Yeah. I'll I have not received that feedback from any of the sites, but I'll turn it to Doctor Aslam to see if he's gotten any additional insight as he speaks to these sites often weekly, if not daily.
Shakil Aslam: Sure. Yes, so one of the sites which is Veterans Affairs Medical Center, they did have some issues earlier on of 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 the rest of the sites have not been affected by that.
Vincent J. Angotti: And that VA site, Nazibur, is not one that is currently enrolling. Doctor Aslam, when he says, adds the four months to it, that's until enrollment occurs. So we expect them before the end of the year now.
Nazibur Rahman: Got it. Thank you for taking my questions.
Vincent J. Angotti: Sure. Thanks, Nazibur.
Shakil Aslam: Thank you.
Operator: Once again, should you have a question, please press 5, or the one on your telephone keypad. And there are no further questions at this time. I will now hand the back to Vincent J. Angotti for any closing remarks.
Vincent J. Angotti: Thank you, operator. And again, thank you for joining our third quarter earnings call. We are 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 2026 and achieve a potential FDA approval of NIAID in late 2026. We hope you appreciate our transparency and site activation. 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, Inc. That concludes our call. This concludes today's call. Thank you for participating. You may all disconnect.