Nektar Therapeutics

Good day, and thank you for standing by. Welcome to the Nectar Therapeutics Third Quarter 2023 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 CEO, Dr. Jonathan Zalewski, our Chief of Research and Development, Dr. Mary Tagliaferri, our Chief Medical Officer, and Jennifer Roddick, our Chief Business Officer. Unfortunately, Incidentally, 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, we expect to make forward-looking statements regarding your business, including statements regarding the therapeutic potential of and future development plans for drug candidates in 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 arrangements, 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 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 August 9th 2023, 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 the IR page of Nectar's website and 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. In the third quarter, we made substantial progress in advancing our development programs. First, on RESPEG, we're pleased to say that we began initiating our first clinical sites in October for the Phase IIb trial of RESPEG in patients with ectopic dermatitis. We expect the first data from this study on the primary endpoint of easy reduction over the 16-week induction period sometime in the first half of 2025. The strength of our data from the randomized Phase Ib study gives us much optimism that we will be successful in the Phase 2b study. These data were recently presented at the 2023 EADV meeting in an oral late-breaking news plenary session. And Jay Z will summarize some of the new data presented later on in this call. But importantly, we observed a consistent benefit with monotherapy RESPEG across multiple clinical efficacy endpoints and patient-reported outcomes. As Dr. Silverberg mentioned in his plenary talk, the Phase 1B trial of RESPEG is the first randomized placebo-controlled study to offer an exciting proof of concept for the important role of T regulatory cells in treating autoimmune disease. And it was exciting to see that this benefit was maintained for many patients through 36 weeks after treatment ended. This substantial benefit observed with RESPEG could eliminate the need for frequent maintenance dosing for patients with ectopic dermatitis, and it positions RESPEG with its novelty regulatory cell mechanism as a potential new treatment option which could be highly disruptive in the biologic treatment landscape for ectopic dermatitis. The biologic market for ectopic dermatitis is a multibillion-dollar market and growing. This landscape includes many IL-13-based mechanisms which overlap with one another, and RESPEC offers the unique promise of a new mechanism in this landscape and a new treatment paradigm that is well tolerated. This is why we're so optimistic about RESPEC's potential. Our goal is to ensure enrollment proceeds on track to deliver data from the randomized Phase IIb trial on our planned timeline in the first half of 2025. This past quarter, we expanded our plan for a second study in alopecia areata from its original randomized phase 2A study design in approximately 40 patients to a randomized phase 2B study design in approximately 80 patients. This is consistent with standard studies in this area, and the incremental cost of this study is still within our projected budget. Importantly, this study will read out around the same time as the ectopic dermatitis study. We believe there's an opportunity for ResBag to become a novel biologic mechanism in alopecia. which has no currently approved biologic treatments, and JAK inhibitors are the primary treatment mechanism. We know JAK inhibitors have cardiac safety concerns and patients experience a rebound after discontinuing therapy, so there's a high unmet medical need for those patients for a new treatment option. With the collective data we've generated to date on RESPEG and ectopic dermatitis and other autoimmune diseases, we believe there's a strong scientific rationale for RESPEG with its Treg mechanism in action to be able to address the underlying pathogenesis of alopecia, and Jay Z will discuss the scientific rationale for this study in a moment. We plan to submit the IND for this study to the FDA by year end, and we expect to initiate the study shortly thereafter. We're also continuing to advance our preclinical programs in immunology, including our TNFR2 agonist antibody, that offers a promising mechanism for multiple sclerosis, ulcerative colitis, and other autoimmune indications as well. Our goal is to submit an IND for this antibody program in 2024. Moving on to NECTAR-255, we're pleased to have recently announced our new clinical study collaboration with Cellular Biomedicine Group, also known as CBMG, to evaluate NECTAR-255 in combination with CBMG's TIL therapy in lung cancer patients that don't respond to anti-PD-1 therapy. CBMG is adding NECTAR-255 to its ongoing Phase I study being conducted at Duke University Cancer Institute and other investigator sites in the U.S. We're also continuing our other clinical work with NECTAR-255 while we evaluate additional strategic partnership pathways for the program. We entered the quarter in a strong financial position with $373 million in cash, and as I stated earlier, we are well-positioned to be able to advance our planned clinical studies while maintaining a cash runway into the middle of 2026. The goal is to reach multiple value-enhancing Phase II milestones for RESPEG in the first half of 2025, and we believe we are well-positioned to execute on this. Since many of you have been asking about the status of our litigation with Lilly, I'll make a brief comment that we continue to actively pursue the litigation and remain confident in our legal position. With that, I'll hand the call over to Jay-Z for an R&D discussion. Jay-Z.