Nektar Therapeutics

Good day and thank you for standing by. Welcome to the Nectar Therapeutics second 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 Tacliaferri, our Chief Medical Officer, and Sandra Gardner, our Chief Financial Officer. On today's call, we expect to make forward-looking statements regarding your 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 certain 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, 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 May 10, 2024, which is available at sec.gov. We are to take 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, and thank you all for joining us today. We've made good progress in the second quarter towards our goal of building a highly promising best-in-class pipeline focused on immunology and inflammation. In this quarter, we continue to make significant advancements with our lead program, Respeg-Aldis-Lucan or Respeg. Respeg is designed to both dampen the inflammatory response and simultaneously restore immune balance by directly expanding functional Treg cells and engaging multiple immunoregulatory pathways in patients with autoimmune disorders. Respeg has generated promising data which supports its potential to become a highly differentiated novel treatment for immune disorders. These data include the phase 1B efficacy data in ectopic dermatitis, which is the most common chronic inflammatory skin disease, and is marked by dysregulation of the immune system, and specifically excessive activation of autoreactive and inflammatory T cells. Respeg is designed to address this root dysfunction, dysregulation, by proliferating regulatory T cells, which can act on multiple inflammatory pathways at once. Respeg is a first-in-class agent in the most clinically advanced program of its kind, targeting ectopic dermatitis, which is traditionally focused on signal pathway antagonists. I'll let Jay-Z talk more about this in a moment, but I'm proud to announce that we have an upcoming paper accepted in Nature Communications and a presentation at the EADV conference in September, which illustrate Respeg's mechanism. These publications will feature extensive biomarker analyses, from our Phase 1B studies in immune-driven skin-related disorders of ectopic dermatitis and psoriasis. Respec is advancing nicely in the two Phase 2B studies that Nectar is conducting in ectopic dermatitis and alopecia areata. Enrollment for both studies remains on track. The ectopic dermatitis study is enrolling 400 patients throughout approximately 110 clinical investigator sites in the U.S., Canada, Europe, and Australia. Patients who are enrolling in the study are diagnosed with moderate to severe ectopic dermatitis and are also biologic naive and have failed topical treatment options. Importantly, this is the identical patient population studied in the Phase 1b study of ResBag. Jay-Z will talk more about this study design later in the call. And as I just stated, enrollment is on track for top-line data readout from the study's 16-week induction treatment stage in the first half of 2025. Data from the maintenance stage, which looks at maintenance dosing every four weeks and every 12 weeks, will be available towards the end of 2025 and early 26. There's a high unmet need for distinctive new mechanisms to treat ectopic dermatitis. With the extent and breadth of studies being conducted right now and the competition for patient recruitment, I am proud that we're achieving our enrollment goals. We believe that this is driven by a combination of the compelling RESPEC Phase 1b data presented at EADV 2023 and, of course, the hard work of our clinical team. In the U.S., there are approximately 30 million people living with ectopic dermatitis, and half of these patients are diagnosed with moderate to severe disease. And it's estimated that under 10% of patients who could receive biologics today are actually receiving treatment. We believe that new mechanisms are the key to growing this market and that there's a high unmet medical need for novel treatment options. So we are excited that Respeg is poised to emerge as a highly differentiated potential treatment for these patients. Now, as you know, we have a second phase two study for Respeg that is enrolling 84 patients with alopecia areata. Enrollment for this study opened in March and the enrollment also remains on track for this study. We're looking forward to top line data from this trial in the middle of 2025, which is estimated to be a few months following the top line readout from the phase two study in ectopic dermatitis. We believe there's a significant potential for Respec to help people with this devastating disease. Nearly 7 million people in the US alone have or will develop alopecia areata. This disorder significantly affects the quality of life for patients, and the currently available JAK inhibitor therapies are not durable, have high relapse rates, and carry significant safety risks. Therefore, there's an urgent unmet medical need for these new therapies. On the preclinical side, we continue to advance NECTAR-0165, our novel TNFR2 agonist antibody program. In June, We reported the first preclinical data on this program at ULAR. These data show that Nectar-0165 is a unique antibody with monomeric activity that selectively binds to TNFR2 on Tregs to enhance their immunoregulatory function. Given the importance of TNFR receptor 2 in certain autoimmune diseases, Nectar-0165 could potentially become a first-in-class treatment for autoimmune diseases such as multiple sclerosis, ulcerative colitis, lupus, and vitiligo. We're currently conducting IMD-enabling studies with the goal of preparing for an IFD submission in the middle of 2025. Next, I'd like to give you an update on Nectar 255, our IL-15 program in oncology. As you know, Nectar is completing a study in large B-cell lymphoma, or LBCL, and Mary will be discussing this later in the call. In addition to the clinical study we're completing in LBCL, there are clinical studies ongoing for NIPTR255 being funded by our collaborators, Merck KGA in bladder cancer and Abel Zeta in non-small cell lung cancer. We also have an IST study ongoing at the Fred Hutchinson Cancer Center and an IST that recently concluded at Stanford. Stanford University recently published data from their IST and the peer-reviewed journal of the American Society of Hematology, Blood. The online manuscript has been posted and it will be in print shortly. Stanford reported data that showed a doubling of recurrence-free survival at 12 months when Nectar 255 was combined with their investigational CD1922 CAR T therapy compared to historical controls with their investigational therapy alone. In addition to these studies, Mary will discuss more on the other studies for NECTAR-255 and the strength of the data to support combination with cell therapies. As the data emerged this year, we believe that NECTAR-255 can become an important component of cell therapy in cancer, and we continue to evaluate strategic partnership opportunities for this program. Before I hand the call over to Jay Z, I just want to say that NECTAR remains in a strong financial position with a cash runway that extends into the third quarter of 2026, giving us more than a year's cash at the time of RASPEG's top-line data results. And with that, I'd like to hand the call over to Jay Z for an R&D discussion. Jay Z?