Nektar Therapeutics

Good day, and thank you for standing by. Welcome to the Nectar Therapeutics First 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 Zalewski, our Chief Research and Development Officer, Dr. Mary Tagliaferri, our Chief Medical Officer, and Jennifer Roddick, our Chief Business Officer. Unfortunately, Sandra Gardner, our acting chief financial officer, was not able to make it on today's call due to an unexpected family emergency. On today's call, they expect to make forward-looking statements regarding her 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 successful of our collaboration agreements, the expectations following our corporate restructuring and reorganization, 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-K that was filed on March 5th, 2024, which is available at sec.gov. We undertake no obligation to update any of these further links, whether as a result of information, future developments, or otherwise. A webcast of this call will be available on the IR page of Nectar's website at Nectar.com. Before turning over the call to Howard, I would like to note that our team is dialing in from different locations and that Howard will be moderating the Q&A session for our team so we can avoid technical issues during the session. We appreciate your patience. With that said, I would like to hand the call over to our President's CEO, Howard Robin. Howard?

Thank you, Vivian, and thank you all for joining us today. We've begun 2024 with positive momentum as we continue to build a best-in-class pipeline focused on immunology and inflammation. One of our key goals is to address the underlying deficiency in regulatory T-cells which underlie a range of serious immune disorders. We have several key immunology targets and first-in-class mechanisms in our pipeline, including our lead program, ResPeg, as well as a new TNFR2 agonist, Nectar-0165, both of which target immune-resolving pathways. In the first quarter, we continued to make significant advancements with our ResPeg program. As you know, we're evaluating ResPeg in a Phase IIb study in moderate to severe ectopic dermatitis, which started last year, and the study is currently enrolling patients worldwide. I'm pleased to report today that the study enrollment is on track to report top line data from the study's 16-week induction period in the first half of 2025. There are approximately 30 million people in the U.S. alone living with ectopic dermatitis, and half of these patients are diagnosed with moderate to severe disease. Biologic treatments in ectopic dermatitis represent a multibillion-dollar market that continues to grow, and we're excited that RESPEG could become a highly differentiated treatment for ectopic dermatitis, a disease that still has a high unmet need for safety and durable treatment options. We believe RESPEG has the potential to be a significant advancement in the treatment of ectopic dermatitis. The new and corrected data from the Phase 1b study we reported at the EADV conference last year showed a dramatic drop of 83% in E-size scores over 12 weeks of treatment. Notably, the study also showed that RESPEG resulted in durable responses 36 weeks after treatment ended, opening up the potential for RESPEG to have an immunomodulatory effect. This past quarter, we initiated our second Phase 2b study of RESPEG in patients with severe to very severe alopecia areata. We believe there is a significant opportunity for Respec to help people with this devastating disease. Nearly 7 million people in the U.S. alone have or will develop alopecia areata. This disorder significantly affects the quality of life for patients, and the currently available therapies are not durable, have high relapse rates, and carry significant safety risks. Therefore, there's an urgent unmet medical need for new therapies. Enrollment opened in March for the Phase 2b alopecia areata study to evaluate RESPEG over a 36-week induction period. Jay Z will talk more about this program later on the call. Enrollment is on track for this study, and we expect to report top-line results in the first half of 2025. In addition, we're advancing NECTAR 0165, our novel TNFR2 agonist antibody. TNFR2 has been shown to potentiate the suppressive effects and overall functional properties of Tregs. This program is built on what we've learned through our deep experience with RESPEG and the Treg field and represents a promising first-in-class differentiated mechanism for multiple sclerosis, ultracive colitis, and a range of other autoimmune diseases. We're currently conducting IND-enabling studies with the goal of submitting an IND in mid-2025. And I'm pleased to announce that our preclinical data has been selected for a presentation at ULAR, and we're looking forward to presenting the first data on this program. Moving to Nectar 255, our IL-15 program in oncology, we're continuing our clinical work with our partners, and we expect data from some of these partners this year. And consistent with our strategic focus in immunology and inflammation moving forward, we're continuing to evaluate strategic partnership opportunities for this program. Finally, Nectar is in a strong financial position with a cash runway that extends well into the third quarter of 2026. I'm very proud of our team at Nectar, and we are laser-focused on executing the development plans for RESPEG in order to achieve value-enhancing data milestones next year. And with that, I'll hand the call over to Jay Z for an R&D discussion.