Nektar Therapeutics

Hello and thank you for standing by. Welcome to the Nectar Therapeutics second quarter 2026 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. On today's call, you will hear from Howard Robin, our President and Chief Executive Officer, Dr. Jonathan Zalevsky, our Chief Research and Development Officer, and Linda Rubinstein, our Chief Financial Officer. Dr. Mary Tagliaferri, our Chief Medical Officer, will also be available during the Q&A. Before we begin, I would like to remind you that we will be making forward-looking statements regarding our business, including statements related to therapeutic and commercial potential and development plans for Raspeg-Aldis-Lukin, the timing and expectations for clinical trials, clinical data presentations, and regulatory submissions. Regulatory interactions are expected cash runway and other statements regarding the future of our business. Because forward-looking statements relate to the future, There are subject uncertainties and risks that are difficult to predict, and many of which are outside of our control. For a discussion of these risks and uncertainties, please refer to our filings with SEC, including our most recent Form 10-K and subsequent filings. We undertake no obligation to update these forward linking statements, except as required by law. Live webcasts and replay of this call will be available on the impact relations section of our website at NACDR.com. With that, I will hand the call over to Howard.

Thank you, Vivian. Thank you to everyone for joining us this afternoon. In July, we achieved yet another important milestone in Nectar with the initiation of the Global Zenith AD Program, Phase III AD Program for a ResPag-Aldisleukin, also known as ResPag, in moderate to severe ectopic dermatitis. We're excited to be advancing this very important novel medicine towards registration, and the first of several potential indications. Following our end of phase two meeting with the FDA, we also finalized the design of a single registrational phase three study for RESPEG in alopecia areata, which we plan to initiate in early 2027. The registrational study designs for RESPEG build on the positive clinical data we've generated in the first half of this year in patients with ectopic dermatitis and alopecia areata, and also reflects input from our completed regulatory meetings. Jay-Z will talk more about these designs later on during the call. And importantly, with the first phase three studies in ectopic dermatitis now underway, we expect top line data from these studies in mid-2028. And if positive, expect to submit a BLA in 2029. As a novel Treg agonist mechanism, Respeg works fundamentally different by acting upstream of multiple inflammatory pathways to restore immune balance. And to that end, we continue to evaluate new indications for expansion of Respeg's developments in the future. Through TrialNet, we're evaluating its potential in type 1 diabetes in an ongoing phase 2 study. We also believe there are other autoimmune conditions where a Treg mechanism could benefit patients, and we therefore view Respeg as a potential pipeline and a product. Importantly, the market opportunity and patient need in each of our two lead indications are substantial. More than 15 million people in the United States have moderate to severe ectopic dermatitis and currently fewer than 10% are treated with a systemic therapy. We believe that this market will grow with the introduction of novel mechanisms of action as was the case in the psoriasis market, and that RESPEC is highly differentiated from the other novel MOAs approved or in development. We know that roughly half of the patients on currently available IL-13-based agents, including Depixent, either don't respond to therapy or lose their response over time. This leaves a large unmet need for a new therapeutic option. We believe RESPEC has the potential to alter the treatment paradigm in this indication by offering a differentiated efficacy and safety profile with a long-term, highly attractive monthly or quarterly maintenance dosing regimen. We recently completed extensive market research, which included our 52-week maintenance data for RESPEC. The research reinforces our commercial thesis in ectopic dermatitis. We interviewed and surveyed 151 high-volume prescribers and key opinion leaders in the United States and Europe. A recurrent theme that came up in the research was physician enthusiasm for a novel mechanism of action as compared to overlapping mechanisms of action in the IL-13 class. The resolved AD data was viewed highly positively, including EZ-75 and itch and arrest responses. The quarterly dosing schedule for maintenance and the easy 100 rates were called out as notable and differentiating. The data in comorbid asthma was also cited as a key differentiator as physicians see patients with a range of other autoimmune and allergic comorbidities, which could benefit from a Treg therapeutic approach. Notably, safety was viewed as a key differentiator with no increased risk for infection and no conjunctivitis observed in the RESPEC treatment arms in our Phase IIb Resolve AD study. Importantly, 150 out of the 151 physicians interviewed said that injection site reactions were not a hindrance to prescribing or a barrier for patients and actually preferred a self-resolving short-lived ISR over managing longer duration conjunctivitis. It was clear that physicians would welcome a novel immune modulating mechanism like RESPEG in the treatment paradigm and that RESPEG would likely be prescribed across first, second, and third line populations. The research supports our decision to pursue a label with our registrational program in ectopic dermatitis that captures both treatment naive and experienced patients. Turning to the opportunity in alopecia areata, nearly 6.7 million people in the United States are affected by the disease, and the large majority currently go untreated. There are well-known safety challenges associated with JAK inhibitors, which is the only approved class to treat severe patients, and that has limited their use. In spite of that, the market for agents currently approved for alopecia areata is still projected to grow to $5 billion in 2033. But more than half of dermatologists are not comfortable describing these agents, given their boxed warnings and an ongoing monitoring burden. Our RESPEC market research with physicians in alopecia areata reaffirms this hesitation to prescribe JAK inhibitors. And in addition to RESPEC's safety profile observed to date and its novel MOA, physicians and patients in our research cited RESPEG's twice monthly dosing for alopecia areata patients as more attractive than once daily oral dosing. Physicians also noted the ability to ensure patient compliance with treatment is much higher with an injectable twice monthly regimen. The research reaffirms our belief that RESPEG has the potential to become a preferred and many more. Before I hand the call to Jay Z, I will note that we ended the quarter in a strong financial position with over $1 billion in cash and investments, and our cash runway extends into the third quarter of 2028, past the initial Phase III ectopic dermatitis data readouts in mid-2028. Our team is laser-focused on successful execution of our phase three programs in advancing RESPEG to BLA submission as quickly as possible. With that, I'll turn the call over to Jay Z.