Talphera, Inc.

Welcome to the Telferra third quarter 2025 financial results conference call. This call is being webcast live via the events page of the investor section 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 like to turn the call over to Rafi Esedoryan, Telferra's chief financial officer. Please go ahead.

Thank you for joining us. on the call today. Today, we announced our third 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, Telfaira'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 Securities and Exchange Commission for discussion of the risks associated with such forward-looking statements. These documents can also be found on our website within the investor section. I'll now hand the call over 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 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 core medics 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 NEFRO study. CoreMedx was also provided the right to a Talfaro board seat to which Joe Tedisco, CoreMedx CEO, was recently appointed. In addition to the CoreMedx strategic investment in the first tranche, existing financial investors, Natahala, Roslyn, and Rock Springs Capital, 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 NEFRO study primary endpoint and a stock price trading above 69 cents 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 nephroclinical 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 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 when focusing on medical ICUs and having nephrologists as the principal investigators. We expect continued positive enrollment rates from these institutions and we'll 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've 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 sites activation, we've pushed the estimated timing of study enrollment completion to the first half of next year. Dr. Asim 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, Dr. Asim and I have continued to visit with many of the new study teams at their respective sites. While observing their study engagement, I'm also highly encouraged by the eagerness of these institutions to have Nifamistat available. In their words, Nifamistat, 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 Nifamistat, if approved, will become a primary product in the market for CRRT anticoagulation. Before I turn the call over to Dr. 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 Dr. Asim.