Talphera, Inc.

Welcome to Telfera's second quarter 2024 financial results conference call. This call is being webcasted live via the events page of the investor section of Telfera's website at www.telfera.com. This call is the property of Telfera and any recording is reproduction, or transmission of this call without the express written consent of Telfera is 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 Telfera's website. I would now like to turn the call over to Rafi Asadorian, Telfera's Chief Financial Officer.

Thank you for joining us on the call today. This afternoon, we announced our second quarter 2024 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, Telferis founder and Chief Medical Officer. Before we begin, I want to remind listeners that during this call, we will 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 Telfaira. 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 investor section. I will now hand the call over to Vince.

Thank you, Rafi. Good afternoon, and thank you for joining us on the call. Before jumping into the updates for the quarter, I'd like to congratulate Dr. Palmer on her decision to retire this coming October. Pam was the co-founder and chief medical officer of the company, as well as a dedicated leader for nearly two decades. Dr. Palmer is a renowned physician, pioneer, and longtime entrepreneur with a mission to improve care for patients in the medically supervised setting. Pam has made her mark in the world of pharmaceuticals and healthcare and mentored countless people along the way who will continue her legacy. While she may be retiring, Dr. Palmer will continue to advise Taufera and support Dr. Shaquille Aslam until the NEFRO study has been completed and the potential FDA approval of NIAID is received. So please join me in wishing her all the best in her retirement. I'm happy to report that we now have multiple site screening patients in the study. We had a busy quarter continuing to work through the administrative processes encountered at the academic institutions where the NEFRO study will be conducted. And we have finalized clinical trial agreement terms now with eight large academic institutions, including our potentially highest enrolling sites. The final four site initiation visits of these initial eight institutions are scheduled to be completed this month. While each institution has their own unique upfront administrative activities, once enrolling, we do not expect additional delays as the protocol dictates how the study is conducted. NIAID's breakthrough designation has continued to prove valuable in our interactions with the FDA. Our ongoing real-time communications with the FDA regarding the study have been efficient, and we expect this to continue as we progress the study over the coming months. For example, we recently requested and promptly received the FDA's approval to increase the number of nephro study sites to a maximum of 14. We sought this approval to one, expedite study completion by increasing the number of high volume CRRT institutions, and two, maintain access to a broad patient population to inform healthcare providers on the use of NIAID if approved. Dr. Aslam's nephrology expertise and established professional network has already proven invaluable in identifying this expanded base of potential clinical sites in support of the study. As communicated on the last call, Dr. Aslam joined TALFERA as our new chief development officer on May 20th. Dr. Aslam has over 20 years of clinical research experience specializing in nephrology. Dr. Asim joined us from Biochrist Pharmaceuticals, where he served as vice president, clinical development, nephrology, and rare diseases. He's held development roles at Angen, Fresenius, and Amgen, and was an assistant professor at Georgetown University Hospital for 12 years, focused on clinical care of acute and chronic kidney disease, hypertension, renal transplantation, and other nephrological diseases. Dr. Aslam's extensive experience across industry and academia as a renal expert, particularly in the design and conduct of both drug and device clinical trials, is impressive and a true asset to our organization. Immediately upon joining Telferra, Dr. Aslam immersed himself in establishing and fostering Telferra's relationships with our selected nephro institutions and research personnel, including personally conducting site initiation activities and training of the institutional teams. Importantly, the balance of our eight sites, including our potentially largest enrolling sites, should be enrollment-ready in the coming weeks. And while we're not prepared to provide guidance on expected study completion and PMA filing timelines, our engagement with the principal investigators remains high. and we believe the study will enroll efficiently at the sites. Recall that the primary endpoint of activated clotting time is measured over 24 hours, with the patient completing the study after activated clotting time is assessed at 72 hours, which is also a secondary endpoint. These relatively short study time points combined with a patient study population of only 166 patients and now expansion to 14 study sites should support efficient completion of the study once fully underway. We expect to provide an updated timeline for study completion, PMA filing, and anticipated PMA approval on our next quarterly call. While the clinical study is ongoing, we've been working on pre-launch commercial activities in preparation for the commercial launch of NIAID, again, if approved. This has included further market research with a group of nephrologists, intensivists, and pharmacy directors. The participants in our research group highlighted Nefamistat's strong safety profile over the last 30-plus years, particularly for patients with liver impairment or contraindications to heparin and citrate. Specifically, The participants commented on the famostat's safety attributes, such as its ultra-short half-life, allowing it to be rapidly cleared and potentially avoiding unwanted complications seen with longer circulating agents, such as heparin and citrate. In addition, our research continues to support the potential commercial uptake of NIAID at a competitive price as compared to the total cost of citrate anticoagulation, which includes the cost of calcium and the required monitoring of calcium levels. These results reinforce our belief that the peak sales estimate for NIAID in the hospital setting approximates $100 million, while a potential opportunity in outpatient dialysis settings could add at least another $100 million of peak sales. We remain focused on the hospital opportunity as this is where our current nephro CRRT study is being conducted. In addition to the progressing clinical study and commercial preparation, we continue to make positive advancements in our manufacturing and related CMC efforts for NIAID. All active ingredient and finished drug production to date have met our specifications We're collecting extended stability data on our GMP-grade product to support shelf life for our potential commercial product. Our manufacturing partners have done an excellent job achieving timelines, specifications, and the cost expectations we've set for them. And before handing the call over to Rafi, it's important to know that our largest investor, Nakahala, remains supportive and with continued progress in the clinical study committed to ensuring Telfer has adequate funding to reach potential PMA approval of NIAID. This continued support is highly appreciated, and as a result of the extension of the original timeline, both parties agree on the need to amend the timing of the planned second close of our financing, which was originally expected to occur by September 30th of this year. Now I'll hand the call over to Rafi to take you through the details of our second quarter financial results. Raf?