Nektar Therapeutics

Good day and thank you for standing by. Welcome to the Nectar Therapeutics first 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 you 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 Sandra Gardner, our Acting 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 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, and 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 February 28, 2023, which is available at sec.gov. We undertake no obligation to update any of these forward-linking 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. As you know, a few weeks ago we announced our plans to implement a new strategic plan and cost restructuring at Nectar. And I'm pleased to report today that we enacted the plan quickly and that we will begin to see ongoing expense savings starting in the third quarter of this year. The new plan focuses our company more clearly on immunology and importantly also extends our cash runway through at least the middle of 2026. A core element of our new pipeline focus and plan is on the advancement of RESPEG, and we intend to move quickly to initiate a well-powered, randomized Phase IIb study for RESPEG in patients with ectopic dermatitis. We were incredibly pleased to have regained the rights to this first-in-class regulatory T-cell program from Lilly. Importantly, there are no royalties owed to Lilly for this transfer, and RESPEG now becomes a wholly-owned asset of Nectar's. Ectopic dermatitis as a target indication for RESPEG is attractive to us for several reasons, not the least of which is the strength of the data that has been generated for RSPEG in patients with ectopic dermatitis. The non-topical biologic treatment landscape is significantly growing. The approvals of Dupixent and other IL-13-based biologics have driven this growth. In the US alone, approximately 16 million people are living with ectopic dermatitis, with three out of four of these affected by moderate to severe disease. In 2021, biologic sales for ectopic dermatitis were close to $5 billion, and sales continue to grow. That being said, ectopic dermatitis is a disease area where there is still a very high unmet need for novel biologic treatment options. Most notably, the mechanisms available to patients today after they fail topical treatments overlap and fall into either the category of IL-13-based mechanisms or JAK inhibitors. Both mechanisms have limitations on efficacy, and both have some notable safety challenges, which include black box warnings with the JAK inhibitor class. Even with the growth in the adoption of these mechanisms, at least 50% of patients don't respond to these therapies at all, and many patients see a rebound in their disease after coming off these therapies. This opens a real opportunity for RESPEG to be introduced as the first regulatory T-cell mechanism that is differentiated from these overlapping existing mechanisms. The Phase 1b data for RESPEG was compelling and set the stage for us to measure the potential for RESPEG to be a remittive therapy with longer-term disease control and less frequent maintenance dosing. Jay Z will review the data reported for RESPEG in a few minutes, including the quality and durability of responses we saw in patients. Now, as we mentioned in our reprioritization plan with a focus on immunology, We'll also continue the development of our IL-15 program, Nectar-255, in cancer while we explore strategic partnership options. Nectar-255 is being developed in combination with cell therapies, and we believe it could be a valuable adjuvant therapy for companies focused in the area of cell therapy. Our Phase II study of Nectar-255 in combination with approved cell therapies, Breonzi and Yaskarta, as well as the Phase II javelin bladder medley study with Merck KGA, will continue while we seek a development partner. We continue to see great value in Nectar 255, and early data showed its promise as a potentiator of cell therapies that could benefit patients suffering from very difficult to treat cancers. Our goal is to find a strategic co-development partner this year. As I've stated earlier, our primary focus is on immunology, and to that end, we have two preclinical candidates advancing, a TNFR2 antibody program and a PEG-CFS1 program, which Jay Z will discuss in a moment. Our goal is to have an IND ready in 2024 for at least one of these programs. We're deeply grateful to our employees for their commitment and dedication to Nectar and the patients we aim to serve. The decisions over the past month to further reduce our head count have been difficult, but we believe these are the right decisions to maximize the success of RESPEG and our immunology programs. We're confident that our focus on immunology is the best path forward to bring important potential therapies to patients and to create value for our shareholders. And now I'll pass the call to Jay Z to review the programs in more detail.