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Talphera, Inc.
3/23/2026
Good morning, everyone, and welcome to the Telfair Virtual Analyst and Investor event. At this time, all attendees are in a listen-only mode. A question and answer session will follow the formal presentations. As a reminder, this call is being recorded and a replay will be made available on the Telfair website following the conclusion of the event. I'd now like to turn the call over to Vince Angotti, Chief Executive Officer at Telfair. Please go ahead.
Thank you, Tara. And good morning, everyone, and thank you for joining our event today. I'm excited to be joined by Dr. Shaquille Aslam, Telfer's chief medical officer, and two key experts in continuous renal replacement therapy, who are also principal investigators in our NEFRO CRRT registrational study. Through their experience and expertise, we hope to provide you with a better understanding of CRRT the anticoagulants currently being used during CRRT, and how these experts see Nifamistat potentially filling an unmet need for anticoagulation of the CRRT circuit. Our agenda will specifically include, first, a very brief business update so we can move quickly to our key expert discussion, followed by Q&A and closing remarks. Before we begin, I want to remind listeners that during this call, we'll 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 Taufera. 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 our website within the investor section. Now for the business update, earlier today we announced our Q4 and full year financial results. The NEFRO CRRT study is progressing nicely and as announced a few weeks ago, we reached the 50% enrollment milestones. This achievement, along with the achievement of some other conditions, triggered the closing of the third tranche of our March 2025 financing, generating gross proceeds to the company of $4.1 million. In addition to the funds received back in October 2025, when two investors waived all their conditions and closed on the second and third tranches of this investment. As of December 31st, we had cash in investments of $20.4 million, which, along with the remaining tranches, if closed, should provide runway through a potential FDA approval of NIAID next year. We expect to complete enrollment of the NEFRO CRRT study later this year and file the PMA within about three months after study completion. As a reminder, the primary endpoint of the study is measured at 24 hours. So a quick turnaround of data is expected once patients have been enrolled. And I'd like to move on to why we're all here today. As a reminder, continuous renal replacement therapy or CRRT is a specific type of dialysis that runs for 24 hours on a slow flow and continues on average between five and seven days while the patient is in the intensive care unit, the ICU. Because the blood clots when it comes in contact with an outside material, the filters used in CRRT machines frequently clog. Therefore, to make sure the patient is receiving continuous therapy that is not interrupted by clotting, international guidelines specify using an anticoagulant to make sure the filters remain functional for as long as possible. As you'll hear today, each hospital currently has a different protocol to achieve the best uninterrupted therapy for the patient, sometimes not using an anticoagulant at all, because many physicians don't trust the current options being heparin or citrate. Other times, physicians select one of the two available options despite their limitations. I'll now hand the call over to Dr. Aslam to introduce our key experts so you can hear directly from them how each of their institutions manage CRRT for their patients and their broad experience with CRRT and currently available anticoagulants. Dr. Aslam?
Yes, thanks Vince. So good morning and welcome to an exciting session with our two experts in acute kidney injury and continuous renal replacement therapies. My name is Shakeel Aslam. I'm the Chief Medical Officer at Telfarum. As a nephrologist, I have had special interest in acute kidney injury dialysis, continuous renal replacement therapy for over 30 years, first as a clinician and then as a device and drug developer in these areas. It's my privilege to have Drs. McMahon and Teixeira join us on this call. In addition to being key thought leaders in AKI and CRRT, Dr. McMahon and Teixeira are also principal investigators on our NIAD registrational trial. In fact, their sites are the highest enrolling sites for our study. So we are very excited to have them. I would like to briefly introduce them. However, I will not be going through their entire list of accomplishments and contributions to this field for the sake of time. So first, Dr. McMahon. Dr. McMahon is an associate professor of medicine at the Medical University of South Carolina in Charleston. Her key interests are in the areas of acute kidney injury and renal replacement therapies in intensive care setting. She has published over 50 papers in leading peer reviewed journals and has written numerous expert opinions, review papers and book chapters. She is the Director of Neurofnephrology Clinical Trials at MSU and is involved in several ongoing studies in acute kidney injury and continuous kidney replacement therapy. Dr. McMahon is also the Director of CRRT Program at MSU and is responsible for managing prescription protocols for CRRT and dialysis in the intensive care unit. She has won multiple teaching awards at Johns Hopkins, MUSC, and University College Dublin. Dr. Teixeira is an associate professor in the divisions of nephrology, pulmonary critical care, and sleep medicine at the University of New Mexico in Albuquerque. In addition to other clinical responsibilities, Dr. Teixeira serves as the Director of Acute Dialysis and Continuous Renal Replacement Therapy Programs at UNMH. As a critical care nephrologist, his research interests lie in acute kidney injury, CRRT, and septic shock, among others. He has enrolled over 300 critically ill or hospitalized patients into more than a dozen clinical trials. He has co-authored over 100 peer-reviewed publications, book chapters, and conference abstracts. He's on the editorial boards of three journals. As a director of the CRRT program at UNM, Dr. Teixeira is responsible for overseeing the development of CRRT protocols and quality assurance programs. So welcome to our call, Dr. McMahon and Teixeira. So nice to have you. Thank you. Good morning.
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