Nektar Therapeutics

Good day and thank you for standing by. Welcome to the Nectar Therapeutics fourth quarter 2024 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Vivian Wu. Please go ahead.

Thank you, Crystal, and good afternoon, everyone. Thank you for joining us today. With us on the call are Howard Robin, our President and Chief Executive Officer, Dr. Jonathan Slavsky, our Chief Research and Development Officer, Dr. Brian Codson, our Interim Chief Medical Officer, and Sandra Gardner, our Chief Financial Officer. On today's call, we expect to make forward-looking statements regarding our business, including statements regarding the therapeutic potential of and future development plans for drug candidates and research programs, the timing of initiation of clinical studies and the availability of clinical data for drug candidates, the timing of plans for future clinical data presentations, the formation, future development plans, or success of our collaboration agreements, financial guidance, and certain other statements regarding the future of our business. Because forward-looking statements relate to the future, they're subject to uncertainties and risks that are difficult to predict, many of which are outside of our control. Our actual results may differ materially from these statements. Important risks and uncertainties are set forth in our Form 10-Q that was filed on November 8, 2024, which is available at scc.gov. We undertake no obligation to update any of these forward-looking statements, whether as a result of new information, future developments, or otherwise. A webcast of this call will be available on the IR page of Nectar's website at Nectar.com. With that said, I would like to hand the call over to our president and CEO, Howard Robin. Howard?

Thank you, Vivian. Thank you all for joining us today. 2024 was a productive year for Nectar, and I'm very proud of our team for executing on important clinical development milestones for our lead autoimmune pipeline program, Respec Aldis Lucan, also known as Respec. The achievement of these clinical development goals prepares us for meaningful data catalysts for ResVag in 2025. Earlier this year, we announced the enrollment completion for both our Nectar-sponsored Phase IIb studies. Our 400-patient Resolve-AD trial in ectopic dermatitis opened enrollment in October of 23 and completed enrollment in just 14 months. Our 90-patient Resolve-AA study in alopecia areata opened in March of 2024 and completed enrollment in roughly one year. Both studies were completed on schedule in highly competitive clinical trial landscapes for both indications, which I think demonstrates the enthusiasm from patients and physicians for RESPEC's novel mechanism of action and for the data that has been generated to date. Jay Z will discuss in a minute some of the unique operational features of our studies that are designed to minimize clinical operational risk. We look forward to data from both trials in ectopic dermatitis and alopecia areata in the second quarter and fourth quarter of this year, respectively. Now in the U.S. alone, there are over 15 million people living with moderate to severe ectopic dermatitis. And we know that less than 10% of those patients who could receive biologic treatments for this chronic skin disorder are actually receiving treatment. New mechanisms are the key to growing this underserved market. This belief also extends to alopecia areata. According to the National alopecia areata Foundation, nearly 7 million people in the US alone have or will develop this disease and a treatment market that is estimated to reach 5.2 billion in the United States and Europe by 2023. This disorder significantly affects the quality of life for patients, and the approved JAK inhibitor therapies with their high relapse rates are not durable and can carry significant potential safety risks. With RESPEG, we hope to offer a more durable treatment option in the form of a novel immunomodulating mechanism. And moving on to type 1 diabetes, we recently announced the clinical trial agreement with TrialNet, an international clinical trial network at the forefront of diabetes research, in which they will conduct and fund a Phase II clinical trial to investigate RESPEG in 66 patients with new-onset type 1 diabetes. We're proud to support TrialNet's mission of advancing innovative mechanisms aimed at slowing or stopping the progression of this disease. Nearly 2 million people in the U.S. have type 1 diabetes, and the disease incidence continues to rise at a rate of 3 to 5 percent per year. And Brian will talk more about this later in the call. And turning to the progress we've made with our preclinical programs, over the past year, we expanded the company's preclinical pipeline in immunology and inflammation. First, we continue to advance our novel TNFR2 agonist antibody program, Nectar 0165. IND-enabling studies are ongoing with the goal of preparing for an IND submission in the second half of 2025. Last year, we presented the first preclinical data at ULAR showing that this antibody demonstrated selective enhancement of Treg cell function. Given the importance of TNFR receptor 2 agonism in a number of autoimmune diseases, Nectar-0165 could potentially be developed in autoimmune diseases such as multiple sclerosis, ulcerative colitis, and vitiligo. We're also designing a pipeline of bispecific molecules that pair TNFR2 agonism with other antibody targets, and we're planning for the first bispecific in this program to be ready for an IND-enabling studies within the next quarter. We look forward to providing more color on our early pipeline as these programs progress, and Jay Z will discuss more on this later. Now, before I turn to the R&D discussion, I want to reintroduce Brian Kotzen, who we announced last month would be returning to Nectar to lead the development of ResBag as interim chief medical officer. Brian has over 40 years of expertise in immunology and has extensive development and management experience. He's also been supporting the clinical development of RESPEG in various capacities since 2017, and his intimate familiarity with this program has provided a seamless transition. And before I hand the call over to Brian, I want to highlight that Nectar remains in a strong financial position with a cash runway that extends into the fourth quarter of 2026 ending 2024 with $269 million in cash and investments on hand. I'm going to ask Brian to share a few comments on his enthusiasm for RESPEG and also comment on our recent announcement for the program in type 1 diabetes before we turn it over to Jay Z to review more details on RESPEG's ongoing phase 2b studies and our early pipeline programs. Brian?