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Talphera, Inc.
8/12/2026
Welcome to the Telferra Second Quarter 2026 Financial Results Conference Call. This call is being webcast live via the events page of the Investors Section of Telferra's website at www.telferra.com. You may listen to a replay of this webcast by going to the Investors Section of Telferra's website. I would now like to turn the call over to Raffi Asadorian, Telferra's Chief Financial Officer.
Thank you for joining us on the call today. Today we announced our second quarter 2026 financial results and associated business updates in a press release. With me today are Vince Angotti, our Chief Executive Officer, and Dr. Shakil Aslam, Telphera'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 telthera. 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 now hand the call over to Vince.
Thanks, Raffi. Good afternoon, and thank you to everyone joining our call today. We remain on track to complete enrollment in the NEFRO CRRT study later this year. This registrational trial is designed to evaluate whether Nefamistat is a safe and effective anticoagulant for use during continuous renal replacement therapy, or CRRT. The study is being conducted in hospital ICUs with nephrologists leading as principal investigators. With all of our final clinical sites now activated, we have reached 75% enrollment in the nephro CRRT study. This progress allows us to increasingly turn our attention to the commercial aspects of Nifamistat. We remain especially pleased with the high level of engagement from our principal investigators and study site personnel. Today, we'll share some details on these areas along with some initial insights from our updated market research on Nifamistat and the CRRT space. On the commercial front, clinical guidelines are an important part of the treatment landscape and were encouraged by recent developments. Specifically, the KDGO 2026 Clinical Practice Guideline for Acute Kidney Injury and Acute Kidney Disease is currently pending final publication following the close of its public comment period in May. KDGO, which stands for Kidney Disease Improving Global Outcomes is the global nonprofit organization that develops and implements evidence-based clinical practice guidelines in kidney disease. Of note, the guideline now references Nifamistat as an acceptable regional anticoagulant. The only available regional anticoagulant being used in the U.S. today is citrate, yet regional citrate's not FDA-approved for CRRT, and it's also complex to use and has other limitations. As a result, most U.S. sites simply don't incorporate it into their CRRT protocols. This is the first time the Phamistat has been recommended in the KDGO guidelines supported by historical studies and publications, a positive change from prior published recommendations. CADIGO guidelines are widely referenced by healthcare providers internationally. We believe this guideline will provide momentum for the commercialization of Nefamistat if approved. This new guidance should further highlight to healthcare professionals that Nefamistat is already standard medical practice and Japan and South Korea, where it is the most widely used method of anticoagulation during CRRT. A 2018 national survey in Japan found that Nefamistat was used in about 80% of cases, making it the most common method of circuit anticoagulation. In South Korea, Nefamistat was approved for this use in 2005 and remains one of the most widely used anticoagulation methods today. In addition, our updated market research on the CRRT space points to a larger market opportunity for Nefamostat than initially estimated. This research puts the estimated annual CRRT procedures in 2027, the projected timing of a Nefamostat launch, at approximately 200,000 in the United States. That's a 21% increase from our prior estimate of 165,000, driven by new data from this research. We also expect a number of CRRT procedures to continue growing annually. We believe Nifamistat, if approved, can address an unmet need in the market given the disadvantages of systemic heparin and regional citrate. Addressing that unmet need provides Nifamistat with an opportunity to gain a meaningful share of the CRRT anticoagulant market. These market insights are consistent with what we're hearing directly from principal investigators and other physicians about the currently available CRRT anticoagulants. We'll share the complete findings later this year at another investor and analyst event as we get closer to completing enrollment. Now I'll turn the call over to Dr. Aslam. our Chief Medical Officer, for some comments on the study. Shakil?
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