Nektar Therapeutics

Hello, and thank you for standing by. Welcome to the Nectar Therapeutics fourth quarter 2025 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. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Vivian Wu from Nectar Investor Relations to kick things off. Please go ahead.

Thank you, Crystal, and good afternoon, everyone. Thank you for joining us today. Today, you will hear from Howard Robin, our President and Chief Executive Officer, Dr. Jonathan Zalewski, our Chief Research and Development Officer, and Sandra Gardner, our Chief Financial Officer. Dr. Mary Tagliaferri, our Chief Medical Officer, will also be available during the Q&A. 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 Respec Aldis-Lukens. the timing and plans for future clinical data presentations, and other statements regarding the future of our business. Because forward-looking statements relate to the future, they are subject to uncertainties and risks that are difficult to predict, and 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 latest Form 10-Q available at sec.gov. We undertake no obligation to update any of these four leading 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. Good afternoon, everyone. 2025 was a pivotal year for Nectar, and we continue to build on the success with significant progress in 2026. In 2023, we unveiled our plans to focus on the advancement of our immunology and inflammation pipeline programs, which center around the biology of T regulatory cells. In October of 23, we began the first phase two study of our novel Treg biologic, RESPEG-Aldisleukin, in patients with moderate to severe ectopic dermatitis. In early 2024, we began our second Phase II study in patients with alopecia areata, and just last year, a third Phase II study in type 1 diabetes was initiated with our collaborator, TrialNet, who is fundering and sponsoring this trial. In the second half of 2025, we saw the successful outcome of several years of hard work by our team as we achieved the first positive results from the two Phase IIb studies of RESPEG in ectopic dermatitis and alopecia areata. The results validated that our novel regulatory T-cell mechanism could produce clinically meaningful outcomes in two dermatological and inflammatory disease settings. And just last month, were reported on the long-term monthly and quarterly dosing results from the 36-week maintenance portion of resolved AD in ectopic dermatitis. These data showed a significant durability of efficacy that was highly competitive to what's seen with other biologics and establishes what our novel Treg mechanism is capable of achieving. Monthly or quarterly dosing of RESPEG during the maintenance period showed a deepening of response with increases in EZ-75, EZ-90, and an up to five-fold increase in EZ-100 scores. Both ectopic dermatitis and alopecia areata are inflammatory dermatological diseases that impact a significant number of patients worldwide. In the U.S. alone, there are over 15 million people with moderate to severe ectopic dermatitis, and it is estimated that today only 10 to 15% of patients are receiving biologic treatments for this chronic skin disorder. Driven by the rapid adoption of biologics, the ectopic dermatitis market is expected to grow to approximately $35 billion by the mid-2030s. Although Dupixent and IL-13s are the predominantly used therapeutics today to treat these patients. About 50% of patients fail to respond or lose treatment effect over time with IL-13-based approaches. This leaves a significant opportunity for a novel immune-modulating mechanism like RESPEG to enter the treatment paradigm. And the competitive landscape has recently narrowed for the late-stage novel method MOAs being advanced to BLA filings. We believe this puts Respec in a lead position as a novel MOA which could offer both a differentiated efficacy and safety profile with a better dosing regimen and the potential to offer patients complete clearance of disease over time. In alopecia areata, there remains a need for an efficacious and safe biologic with a better efficacy and dosing profile. Currently approved JAK inhibitors are effective at regrowing hair in some patients, but they carry a number of drawbacks, and more than half of physicians and patients are hesitant to use these agents because of the safety risks and the associated monitoring burden they pose. Importantly, the JAK class has poor durability, and nearly all patients lose their hair after treatment cessation. With the 36-week data from Resolve AA establishing a clinical efficacy profile similar to low-dose JAK inhibitors in alopecia, We're looking forward to seeing the 52-week data from that study in April. For patients who enter the blinded 16-week treatment extension, we will be evaluating the potential of RESPEG to deepen SALT reductions, including ZUSALT 20 responses. RESPEG's differentiated clinical profile and a safety database of over 1,000 patients treated to date, equivalent to 381 patient years of exposure, provides an exceptionally strong basis for advancing RESPEG into Phase III studies. In June, we will be randomizing the first patient in the Phase III studies in ectopic dermatitis. We now have alignment with the FDA on our Phase III dose, the 24-week induction treatment period, and other critical Phase III study design elements. Jay Z will review that in a moment. We expect to have the first data from Phase III in mid-2028 and meet our goal to submit a BLA in 2029. We ended 2025 with $245.8 million in cash and investments and with no debt on our balance sheet. Since year end, we've also raised approximately $476 million in additional net cash through both a public offering and exercising a portion of our ATM. Our very strong balance sheet now allows us to move quickly into phase three. I'll now turn the call over to Jay-Z, who will share more on RESPEG and our other immunology programs. Jay-Z?