Talphera, Inc.

Welcome to the Telferra First Quarter 2025 Financial Results Conference Call. This call is being webcast live via the events page of the investor sections of Telferra's website at www.telferra.com. You may listen to a replay of this webcast by going to the investor section of Telferra's website. I would now like to turn the call over to Raffia Sadorian, Telferra's Chief Financial Officer.

Thank you for joining us on the call today. Today, we announced our first quarter 2025 financial results and associated business updates in a press release. With me today are Vince Angotti, our Chief Executive Officer, and Dr. Shaquille Aslam, Telfair'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 Telfera. Please refer to our press release in addition to the company's periodic current and annual reports filed with the SEC 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 hand the call to Vince.

Thanks, Rafi. Good afternoon, and thank you to everyone joining our call today. It's only been about six weeks since our last call, so we're going to keep our prepared remarks brief. We began 2025 with strong momentum with a focus on the execution of our NEFRO CRRT trial that resulted in the approval from the FDA on a significantly decreased study size, the removal of certain exclusion criteria, and the activation of additional high volume sites to accelerate enrollment. In addition, a pipe financing was also completed. As detailed on our year-end call, we made tremendous progress with the study protocol changes, highlighted by the reduction in the size of the study to 70 patients from 166. This certainly helps with shortening the time to complete the study, but importantly, so does adding more of the right clinical study sites and principal investigators. As a reminder, we've been focused on the new site profile, specifically one, the type of intensive care unit where the study will be performed, for example, medical ICUs instead of surgical or cardiothoracic ICUs. Two, the specialty of the principal investigator, again, specifically a nephrologist as a primary lead for selecting patients to enroll compared to an intensivist or other specialist. And three, the efficiency of the administration to initiate a new study at their institution. Dr. Aslam identified these site characteristics after his review and learnings from assessing the initial sites as critical, successful, and timely enrollment. Our new site target profile focused on medical ICUs and nephrologists as principal investigators is proving to make a real difference in engagement and activity at each of the sites. including a more efficient contracting process compared to our legacy sites, all supporting our belief that we're engaging with the right institutions and investigators to allow us to complete the study by the end of the year. Adding these new sites is key to achieving that success. And so far this year, we've added three new sites that are activated and screening patients, with five more expected by mid-year. All eight of these sites plus others which we're having contracting discussions fit our new target site profile, including a much more efficient process to finalize contracting compared to the legacy sites. In addition to adding new sites, we believe there are other favorable trends and activities that could support the adoption of the Phamistat if approved. These include first, exploring a compassionate use IDE when we have been approached by multiple institutions and are discussing using Nifamistat under a compassionate use ID for a specific patient population that does not do well with other available anticoagulants. And second, continued shortages of citrate supply and potential supply chain issues with heparin. Healthcare providers are inquiring about the timely availability of Nifamistat given the recurrent heparin and citrate shortages. Dr. Aslam will provide some more information on this, as well as around the ongoing contracting with the new sites. We'll not be providing clinical study enrollment updates until we attain the 17-patient mark, which is the milestone to achieve the next tranche of financing. Before I turn the call over to Dr. Aslam to provide some additional details on clinical activities, let me remind you that if approved, NIAID would become the only FDA-approved regional anticoagulant for use during continuous renal replacement therapy. There are many disadvantages to the currently used products, heparin, which is systemic in nature, and citrate, which is being used off label. Through conversations with many nephrologists, we believe that NIAID would fill a significant unmet medical need during renal replacement therapy. I'll now hand the call over to Dr. Aslam.