Nektar Therapeutics

Good day, and thank you for standing by. Welcome to the Nexter Therapeutics Third Quarter 2022 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 1-1 on your telephone. You will then hear an automated message advising you your hand is raised. Please be advised that today's conference is being recorded. I would now like to hand it 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, Jill Thompson, our Chief Financial Officer, and Dr. Brian Codson, our Chief Medical 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 our drug candidates in research programs, the timing of the initiation of clinical studies, and the availability of clinical data for our 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 are 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 inherent 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 5, 2022, 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 development, or otherwise. A webcast of this call will be available on the IR page of our NECDR website at NECDR.com. With that said, I would like to hand the call over to our President and CEO, Howard Robin. Howard?

Thank you, Vivian. Thank you to everyone for joining us today. During the third quarter, we continued to make meaningful progress toward execution of our new strategic plan, directed to the fields of oncology and immunology, with a sharp focus on three core R&D pillars, Nectar 358, Nectar 255, and our research activities. With Nectar 358 and Nectar 255, our biologic clinical pipeline is poised to generate value-enhancing clinical trial data beginning in 2023 and continuing through 2025. Importantly, our plan provides us with a cash runway through the middle of 2025, and this is exclusive of any potential future cash inflows from new partnering activities. Each program in our pipeline provides us with a distinct and highly promising opportunity to provide patients with novel potential medicines across a range of therapeutic areas, and we're already starting to see encouraging data across our portfolio. This past quarter, we reported positive data for our clinical stage program in immunology, Nectar 358, now known as RegPEG-Aldisleukin, or ResPEG, in the setting of ectopic dermatitis. ResPEG is being developed with our partner, Eli Lilly, in multiple autoimmune diseases, and in addition to ectopic dermatitis, we're also pursuing lupus, and we have plans to go into at least one additional indication, and we look forward to announcing that new indication in the coming months. Our lupus phase two study, which enrolled about 280 patients, is expected to report top-line data in the first half of 2023. And the important Phase Ib data in ectopic dermatitis patients that were presented in Q3 will shape the robust Phase IIb study in this setting, which is planned to start also in the first part of 2023. The design for that study is being finalized now, and Brian will provide further information on the RESPEC program in a moment. Our second significant clinical program is NECTAR-255, our novel, wholly-owned IL-15 agonist being developed in both liquid and solid tumor settings. In large B-cell lymphoma, we're on track to initiate our own sponsored study of NECTAR-255 in combination with approved autologous CD19 CAR-T products. The study is designed to demonstrate the potential of NECTAR-255 to enhance the efficacy benefit of these therapies. This Phase 2-3 trial will be a randomized, double-blind, placebo-controlled study comparing Nectar 255 versus placebo in relapsed or refractory patients being treated with CAR-T cells. It will position us for key comparative data in 2024 for Nectar 255 in second-line and third-line large B-cell lymphoma, which is the labeled indication for these approved CAR-T products. In multiple myeloma, we plan to present the data from the first several patients enrolled in our study of Nectar-255 in combination with Darzalex Faspro at the upcoming ASH meeting in New Orleans. The study is continuing dose escalation and we're encouraged by the early data we see that continue to support the biologic mechanism of Nectar-255. Specifically, we've observed that Nectar-255 can restore blood NK cell levels after Darzalex-mediated NK cell clearance. And finally, the javelin bladder medley phase two comparative study in combination with Avilamab began actively enrolling patients in the third quarter. Our partner Merck KGA is running this study, and we're on track to generate PFS data for this study by the end of 24. In research, we're working on a novel TNF R2 antibody that we believe will be highly differentiated from anything in the field and holds great promise as a next generation selective Treg agent in autoimmune diseases such as multiple sclerosis and inflammatory bowel disease. This will be the first antibody program in our pipeline and we're focused on advancing this important new mechanism to be prepared for IND enabling studies in 2023. In addition, we're continuing to advance our preclinical work in oncology Nectar-288 is a novel PEG conjugate of interferon gamma designed to modify binding of interferon gamma to its receptor and non-receptor substrates and optimize the duration of interferon gamma signaling. Next week at CITSE, we'll present the first set of preclinical data for this program. We ended the third quarter with approximately $546 million in cash, and as I stated earlier, we've implemented a strategic plan which enables us to have a cash runway for through the middle of 2025. We do not anticipate a need to raise capital during this period. We are well-funded with a strong financial position, and we will enable us to drive our key programs forward to value-generating data and milestones. And now I'd like to turn the call over to Brian to provide an update on RESPEG. Brian.