Nektar Therapeutics

Good day and thank you for standing by. Welcome to the Nectar Therapeutics Second Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After this 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 on your telephone. You will then hear an automated message advising you your hand is raised. To withdraw your question, please press star 1 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, Jennifer Ruddock, our Chief Business 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 agreements, the expectations following our corporate restructuring and reorganization plans, 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, 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 at Nectar.com. Before turning over the call to Howard, I would like to note that Jennifer 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 and CEO, Howard Robin. Howard?

Thank you, Vivian, and thank you for all joining us today. The first half of this year has been a pivotal time for us. In April, we implemented a new strategic plan that focuses on our immunology programs and also extends our cash runway through at least the middle of 2026. Our most advanced program is RESPEG, which a large phase 2b study is being initiated shortly for patients with ectopic dermatitis. I'll talk more about that and yesterday's announcement in a moment. We're also continuing to advance our preclinical programs in immunology, a TNFR2 agonist antibody and a CFS1 program. Our goal is to file an IND for one of these programs in 2024. Additionally, we're continuing the two phase two randomized clinical studies for Nectar 255 in solid and liquid tumors. With our new strategic plan, we believe we've created a company that is strongly positioned to get to important value-enhancing phase two catalysts in 2024 and 2025. And these will come well before our cash runway guidance, which extends us into at least the middle of 26. So first and foremost, we're committed to advancing RESPEG, our first-in-class regulatory T-cell program. RESPEG is now a wholly owned asset of Nectar's And preparations are well underway to initiate a randomized phase 2B study for RESPEG in patients with ectopic dermatitis. And we expect to have initial data from this study in the first half of 2025. Yesterday, we announced that clinical efficacy data previously generated by Eli Lilly for RESPEG were incorrectly calculated for both ectopic dermatitis and for psoriasis. This discovery was made after all rights to RESPEG were returned to Nectar, and the raw data files from the RESPEG clinical studies were transferred to Nectar. The internal statistical and clinical teams in charge of these two studies at Lilly were made aware that Nectar discovered the data errors, and Lilly confirmed the errors in writing and written communications with Nectar. The new and corrected data from the ectopic dermatitis study demonstrate that 12 weeks of RESPEG therapy at the highest dose resulted in a mean E-size score improvement of 83% and an E-size 75 response rate of 41%. The corrected data also show RESPEG resulted in a very rapid and steep drop in E-size scores shortly after therapy start, much sooner than existing biologic therapies approved today. And one of the most interesting attributes of RESPEG is that when the 12-week induction treatment period was over and treatment stopped, the mean drop in E-size score continues for patients who were followed in the study. The possibility that Respec would offer both a differentiated mechanism to the existing field of IL-13 therapies and a remittive effect for patients is clearly a provocative one. The biologic treatment landscape for atopic dermatitis is significantly growing. The approvals of Dupixent and other IL-13-based biologics have driven this growth. About 16 million people are living with ectopic dermatitis in the U.S. alone, with 75% of these affected by moderate to severe disease. In 2021, biologic sales for ectopic dermatitis were close to $5 billion, and these sales continue to grow. An agent like RESPEG that eliminates the need for frequent dosing after induction treatment period would be highly disruptive to the multi-billion dollar biologic treatment landscape for ectopic dermatitis. For the therapies available today and near approval, continued and frequent dosing is required to maintain benefit. And in many cases, when a therapy is removed, patients see their eczema, ectopic dermatitis return. And we also know that at least 50% of patients on IL-13 therapies fails to adequately respond to therapy. So clearly, RESPEC holds great promise for treating patients with ectopic dermatitis, and these corrected data reinforce NICTR's strategic plan to invest in a robust Phase IIb study for RESPEC. As we stated in our press release yesterday, we plan on holding an investor meeting and key opinion leader meeting in the coming weeks to discuss these data and share the study design for the Phase IIb trial for RESPEG and ectopic dermatitis. Jayvee will discuss more on the corrected RESPEG data in a moment and also discuss our early stage immunology programs. With respect to our oncology asset, NECTAR255, we're continuing to evaluate potential strategic partnership options for the program at the same time as we're continuing the Phase II clinical trials. I've asked Mary to join us to share more about the ongoing clinical studies for Nectar 255. And with that, I'll hand the call over to Jay Z to discuss RESPEG and our preclinical programs in immunology.