Talphera, Inc.

Welcome to the Telfaira fourth quarter 2023 financial results conference call. This call is being webcasted live via the events page of the investor section of Telfaira's website at www.telfaira.com. This call is the property of Telfaira, and any recording, reproduction, or transmission of this call without the express written consent of Telfaira is strictly prohibited. As a reminder, this webcast is being recorded. You may listen to a replay of this webcast by going to the investor section of Telfair's website. I would now like to turn the call over to Rafi Esadorian, Telfair Pharmaceuticals Chief Financial Officer. Please go ahead.

Thank you for joining us on the call today. This afternoon, we announced our fourth quarter 2023 financial results and associated business updates in a press release. This press release can be found within the Investors section of our website. With me today are Vince Angotti, our Chief Executive Officer, and Dr. Pam Palmer, Telfaira's Founder and 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 at www.sec.gov for a discussion of the risks associated with such forward-looking statements. These documents can also be found on our website within the investor section of talfara.com. I'll now hand the call over to Vince.

Thank you, Rafi. Good afternoon to everyone, and welcome to the first call we're having as Talfara. Throughout 2023, we focused on our objective of repositioning the company around a new portfolio of assets with an immediate priority on NIAID and longer-term strategy on the broader Nafamistat pipeline and other pipeline assets. As these assets have the traits to drive our vision to support healthcare providers in optimizing patient outcomes in medically supervised settings. 2023 was a productive year in achieving this objective, culminating in our ultimate rebranding to TauFera, signifying the completion of this repositioning. With this transition, we believe we've successfully capitalized TauFera to achieve our 2024 goal to advance NIA to a premarket application submission, or PMA. Today, we'll, number one, highlight the activities completed in 2023 that have positioned Taufera for success over the next 12 to 18 months. Two, identify the important upcoming milestones in 2024 And then three, update you on the status of our NIAID registrational study. As for 2023, in April, we closed the transaction with Elora to divest Desuvia to a partner with experience in manufacturing and commercializing controlled substances. This transaction allowed us to complete the reduction in our annual Desuvia-related operating expenses by approximately $14 million. and refocus these resources on the development of NIAID. With this transaction, we earn royalties of 15% on commercial sales, 75% on sales to the Department of Defense, and up to $116.5 million in potential milestone payments. We're confident that Elora is the right partner, and we expect they'll begin commercializing in 2024 after they complete all their work around restructuring and insourcing the supply chain. In October, another pivotal success was achieved. After several months of working on the NIAID study protocol and discussing modifications with the FDA, we received an approval of our IDE from the FDA. This allowed us to start preparations for the single registrational study that we expect to begin enrolling in the coming weeks. The clinical and regulatory teams have designed a 166-patient study, as agreed to with the FDA, that many of our KOLs believe should be quickly enrolled. Remember, Nifamistat is an approved and long-standing product in Japan and South Korea for anticoagulation and other indications with a wealth of safety and efficacy information. Our Nefamistat product candidate, NIAID, has received a breakthrough designation from the FDA. We believe all of this bodes well for a successful clinical trial this year. Dr. Palmer will provide an overview of the study and its status later in the call. Another key achievement in 2023 was the December publication in the journal Renal Failure of our market research with 150 physicians in the U.S., regarding the practices of anticoagulation of the extracorporeal CRRT circuit. Many of the authors of this study are in the process of becoming investigators in our clinical trial and have provided us with valuable information and better understanding how physicians are currently using anticoagulants during CRRT and the potential issues with current standards of care. We hosted two authors of the study and a KOL panel discussion in December which provided interesting insights into the market and clinical practices at two leading academic institutions. We believe that nifamistat, if approved in the U.S., would be an important addition to the market for anticoagulation during CRRT, particularly given the disadvantages raised in this publication of the two anticoagulants currently used, those being heparin and citrate. If approved by the FDA, NIAID would be the only regional anticoagulant approved in the U.S. for the extracorporeal circuit. After achieving these 2023 objectives to reposition the company, we were prepared to proceed with corporate rebranding to ensure all stakeholders were aware of our new vision with a focus on NIAID in the near term. Accordingly, in January, we rebranded the company to TauFera. The new name was derived in part from talisman, meaning a strong leader, and reflects the new pharmaceutical era for the company. This signals the beginning of our newly transformed company, and we're excited about the momentum we have gained and the positive feedback we've received from the many investors we've met with over the last couple of months. Soon after the rebranding, importantly, we announced the completion of two financing events focused on ensuring we have sufficient capital to get to a potential approval of NIAID in the second quarter of next year. The first was a non-dilutive royalty financing closed with Zoma Royalty, where we partially monetized our de suvia royalties and milestones. We received $8 million at closing from Zoma in exchange for the royalties and milestones being paid by Elora. Once Zuma receives a specified amount of payments, we'll share equally in the Department of Defense royalties and the milestone payments. Separately, we closed in equity financing from two of our existing investors, Nantahala and Rosalind. The equity financing provides $18 million in total funds structured over two closings. We received $6 million at the first closing, and another $10 million of committed capital will be received at the second closing upon the announcement of positive NEFRO trial data by September 30 of this year, and an additional $2 million if Telfair stock trades above $0.92 following that announcement. To be clear, this is committed capital once the milestones are met. In addition, should the milestone-based warrants from the July 2023 financing be exercised, an additional $14.4 million of capital would be injected into the company. Concurrent with the equity investment, we were delighted that Abhi Jain from Nantahala agreed to bear on our board of directors, which adds further depth to our experienced board. As you may have seen, we announced last week that the board has decided to reduce the total number of directors to seven from the 10 we previously had. This reduction is consistent with best governance practices of other companies our size. Accordingly, Howie Rosen, Ricca Fable, and Pam Palmer voluntarily resigned from the board. I'd like to expressly thank Howie Rosen and Ricca Fable for all their valuable contributions over the years on our board. And of course, look forward to continuing work with Dr. Palmer as our chief medical officer. Finally, before handing the call over to Dr. Palmer, I'd like to remind everyone of all the upcoming milestones expected over the next 18 months. We anticipate our first patient in the NIAID study to be enrolled in the coming weeks. Once patients begin enrolling, we'll have a better overall sense of the timing but based on feedback received from the various KOLs, we expect this study to enroll quickly. After 32 patients have been enrolled, there'll be a planned interim safety analysis. Top line data readout from the completed study would then be expected by the end of the third quarter with a PMA submission planned for the end of the year. Now with a six month FDA statutory timeline, This would put us on track for a potential PMA approval by the end of the second quarter of 2025. With that, I'll hand the call over to Dr. Palmer, who will provide an update on the NEFRO CRRT or NIAID clinical study. Pam?