Nektar Therapeutics

and thank you for standing by. Welcome to the Nectar Therapeutics First 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 your speaker today, Corinne Franklin, in Nectar Investor Relations, who is filling in for Vivian Wu, who is on maternity leave. 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 Zaleski, our Chief Research and Development Officer, Dr. Brian Kotzen, our 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 the initiation of clinical studies and the availability of clinical data for drug candidates, the timing and plans for future clinical data presentations, the formation, future development plans, or success of our collaboration agreements, financial guidance, and other certain 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, many of which are outside of our control, or actual results may differ materially from these statements. Important risks and uncertainties are set forth in our Form 10-K that was filed on March 14, 2025, which is available at sec.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 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, Corinne, and thank you all for joining us today. During the first quarter of 2025, we've been concentrating on the successful development of our immunology pipeline with a focus on advancing RESPEG-Aldis flukin, also known as RESPEG, in three separate phase two studies and completing the IND-enabling studies for our lead earlier stage program, NECTAR-165, a TNFR2 agonist antibody. RESPEG is a first-in-class T regulatory cell biologic therapy with the broad potential in a number of immune disorders. As a novel immune modulator mechanism, RESPEG is poised to help a significant number of patients battling chronic conditions. In June, we plan to share our first top-line results from the 16-week induction period for the 400-patient Phase IIb study known as RESOLVE-AD, which is studying RESPEG in biologic naive patients with moderate to severe ectopic dermatitis. I will let Jay Z review the upcoming important data milestone and the study design in a moment. Our objective in this study is to demonstrate efficacy and safety and establish a dose to take forward in phase three studies. The study also has a 36-week maintenance period where patients will receive the same dose from induction, but at every four-week or every 12-week dosing intervals. The data from this maintenance period will be available in early 2026. Ectopic dermatitis is a significant opportunity as there's a high unmet need for new mechanisms to treat these patients. There are currently 30 million adult patients with ectopic dermatitis in the U.S. and 220 million adult patients globally. About half of these patients have moderate to severe disease, and this means their eczema covers a significant portion of their body and can severely affect their overall quality of life. According to the National Eczema Association, adults with ectopic dermatitis are three times more likely to experience anxiety and depression, which increases with the severity of the disease. Eczema could also cause severe itching and inflammation, impact a patient's sleep, and lead to body shame. Currently, approximately 8% of the patients with moderate to severe disease are treated with a biologic, most frequently dupexant. And yet, we know that about half of those patients ultimately either don't benefit from treatment or become refractory, and once treatment is stopped, their ectopic dermatitis returns. We believe this is because the approved biologics are effective at controlling the signs and symptoms of the disease, but they do not therapeutically target the underlying disease pathology to restore and heal the skin. As a T regulatory cell therapy, RESPEG instead regulates multiple immune pathways to address the overall disorder, and so we believe it could provide a much-needed alternative to the IL-13 and IL-31-based therapies currently approved for these patients. For our RESPEG-AA Phase IIb study in alopecia areata, we will report top-line results in December of this year. The patients enrolled in this study have severe to very severe alopecia areata, These are patients who have lost at least 50% of the hair on their scalp. In addition, this disease can impact the patient's eyebrows, eyelashes, and facial hair. Nearly 7 million people in the US have alopecia areata and 160 million people worldwide. Many of these patients also have other autoimmune diseases. Our 90-patient study is evaluating a 36-week treatment period for patients with alopecia areata as compared to placebo. We will then evaluate patients once they are off therapy to understand the long-term remittive potential for RESPEG. Today, JAK inhibitors are used to treat alopecia, and we know that when therapy is removed, patients lose their hair again very quickly. Our hope is that RESPEG can provide a new treatment paradigm and a long-term solution for patients battling this chronic condition. In type 1 diabetes, RESPEC has great potential as a T regulatory cell therapy to slow the progressive loss of insulin-producing beta cells, which are the target of the patient's overactive immune cells in this disease. We're looking forward to the start later this year for the important proof of concept study in new onset type 1 diabetes, which is being sponsored and funded by TrialNet. Finally, With respect to our early-stage immunology pipeline, we're advancing NECTAR-165, our TNFR2 agonist antibody program, through IND-enabling studies this year, and we've made great progress on this front. We're on track to complete these studies in 2025 and will be prepared to submit an IND filing. In addition, the bispecific program, NECTAR-166, which incorporates a TNFR2 epitope with a validated antibody target, is also on track, and we're advancing this new program into preclinical studies. Lastly, we remain in a strong financial position with a runway into the fourth quarter of 2026. And with that, I'll hand the call over to Jay-Z for review of the upcoming data milestones. Jay-Z?