Talphera, Inc.

Welcome to the Telfera Second Quarter 2025 Financial Results Conference call. This call is being webcast live via the events page of the Investors section of Telfera's website at .telfera.com. You may listen to a replay of this webcast by going to the Investors section of Telfera's website. I would now like to turn the call over to Rafi Azadorian, Telfera's Chief Financial Officer.

Thanks, Andrew, and thank you for joining us on the call today. Today we announced our Second Quarter 2025 Financial Results and Associated Business Updates in a Press Release. With me today are Vince Angati, our Chief Executive Officer, and Dr. Shaquille Aslam, Telfera's Chief Medical Officer. Before we begin, I want to remind listeners that during this call we will likely make within the meaning of the federal securities laws. These forward-looking statements involve risks and uncertainties regarding the operations and future results of Telfera. 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 be found on our website within the Investors section. I'll now hand the call to Vince.

Thanks Rafi. Good afternoon and thank you to everyone joining our call today. We're excited about the progress made this past quarter, specifically in the acceleration of the Nephro Study enrollment. At the end of last year, upon the announcement of Dr. Shaquille Aslam becoming the Chief Officer of Telfera, we embarked on a restructuring of the Nephro clinical study, which included changing the target profile of our clinical sites, approaching the FDA with various study protocol changes, including the reduction of the study size from 166 to 70 patients, and adjusting internal processes to ensure acceleration of study enrollment with the goal of completing the study by the end of 2025. I'm very pleased to inform you that we now have evidence that all of these changes were indeed the appropriate adjustments, and we're confident that we're on the right path to achieve our goals. We have seen a strong acceleration of the enrollment rate over the last six weeks from the first three sites with our new target profile. This target profile includes a Nephrologist Principal Investigator and the institution screening patients at medical ICUs. As a result, the number of total enrolled patients has more than doubled since May. These sites, combined with six additional new target profile sites that are expected to begin enrolling over the rest of this quarter, should keep us on plan to complete the study by the end of this year. Dr. Aslam and I have recently returned from a visit with many of the new study teams at their respective locations. In addition to observing their study engagement, I'm also highly encouraged by the eagerness of these institutions to have Nephamostat available if approved. In their words, Nephamostat, based on its profile and use in other countries, will be a preferred anticoagulant for CRRT. While we still need to complete the study, this feedback from these investigators continues to strengthen my belief that Nephamostat, if approved, will become a primary product in the market for CRRT anticoagulation. The addition of more of the right clinical study sites and principal investigators has been critical to achieving the increased enrollment rates. As a reminder, the new site profile concentrates specifically on one, the type of intensive care unit where the study will be performed, for example, medical ICUs instead of surgical or cardiothoracic ICUs where many of the legacy sites were focused. Two, the specialty of the principal investigator, specifically a nephrologist as a primary lead for selecting patients to enroll compared to an intensivist or other specialist, which were the specialties of the legacy site PIs. And three, the efficiency of the administration to initiate a new study at their institution. Dr. Aslam identified these characteristics after his review and learnings from assessing the initial sites as critical to successful and timely enrollment. In addition to the acceleration in enrollment at existing new profile sites and the institutional interest in joining the study as we add new sites, we believe there are other tailwinds supporting the market potential of Nephamostat. These include one, advancing a compassionate use IDE. As stated on our last call, we have been approached by multiple institutions and are discussing using the nephamostat under a compassionate use IDE for a specific patient population that does not do well with other available anticoagulants for CRRT. And two, continued shortages of citrate and potential supply chain issues with heparin. Healthcare providers are inquiring about the timely availability of nephamostat given the recurrent heparin and citrate shortages. Now before I turn the call over to Dr. Aslam to provide some additional details, let me remind you that if approved, NIAD 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 Dr. Aslam.