Nektar Therapeutics

Ladies and gentlemen, thank you for standing by, and welcome to the Nectar Therapeutics third quarter 2020 financial results. At this time, all participants' lines are in the 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 and then one on your telephone. Please be advised that today's conference may be recorded. If you require any further assistance, please press star and then zero. I would now like to hand the conference over to your speaker today, Ms. Jennifer Ruddock, Head of Corporate Affairs. Ma'am, you may begin. Thank you, Crystal.

Good afternoon, everyone, and thank you for joining us today. With us on the call are Howard Robin, our President and CEO, Gil Laboucherie, our COO, Dr. Jonathan Zalevsky, our Head of Research and Development, and Dr. Wei Lin, our Head of Development. On today's call, we expect to make forward-looking statements regarding our business, including clinical trial enrollment and clinical trial results, Timing and plans for future clinical trials Timing and plans for future clinical data presentations The therapeutic potential of our drug candidates Outcomes and plans for Health Authority regulatory actions and decisions Estimates and predictions of the COVID-19 pandemic's impact on our business and clinical trials Financial guidance and certain other statements regarding the future of our business Because the forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict and many of which are outside of our control. Important risks and uncertainties are set forth in the Form 10-Q that we filed on August 7, 2020, which is available at www.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 replay of this call will be available on the IR page at NECTR's website at NECTR.com. Before turning over the call to Howard, As we are all dialing in from separate locations, I will moderate the Q&A session for our team so we can avoid technical issues during the session. We appreciate your patience as we work to ensure that there are no technology disruptions for all of those listening. With that said, I will hand the call over to our President and CEO, Howard Robin. Howard?

Thank you, Jennifer, and thank you to everyone for joining us on the call today. Over the past quarter, we've continued to advance our joint development program for BEMPEG with our partner, Prisselmeyer Squibb, including the start of two new studies in Q3, a Phase III registrational study in adjuvant melanoma patients that Nectar is sponsoring, and a new Phase I-II study that BMS is sponsoring, which expands the development of BEMPEG and renal cell carcinoma with a triplet regimen of BEMPEG plus NEVO in combination with a TKI agent. The BEMPEG joint development program with BMS now has six separate studies ongoing for our lead cytokine candidate, including five registrational studies. The registrational program for BEMPEG collectively aims to benefit quite a large patient population across melanoma, renal cell carcinoma, and bladder cancer. And this joint development program for BEMPEG plus NEVO reflects a large investment into BEMPEG, and it underscores the excitement for how this unique and differentiated IL-2 agent may serve as an important backbone therapy with the checkpoint inhibitor nivolumab for the treatment of solid tumors. We're also advancing our development of BEMPEG with the checkpoint inhibitor pembrolizumab in the PROPEL study in non-small cell lung cancer, which is one of the largest solid tumor opportunities for BEMPEG. We are well ahead of our enrollment projections for the PROPEL study, and I'll let Wei share more about this program and more about the progress that we've made in the program in that study in a moment. Next week at CITSE, we will present several new data sets from our immune oncology pipeline, including updated PIVOT-02 data for BEMPEG in melanoma with more than 30 months of follow-up for those patients, as well as the first data for our NECTAR255 program, our IL-15 candidate. As you know, for PIVOT-02, we reported very strong results for BEMPEG plus NEVO in this cohort at last year's CITI with a high complete response rate of 34% with 42% of patients experiencing a 100% reduction of their resist target lesions. And importantly, we recently reported that after 21 months, the cohort had not yet reached a median PFS. These results led to a breakthrough therapy designation for PEMPEG and two large phase three studies in melanoma. one in first-line metastatic melanoma and one in the adjuvant setting. The addressable market opportunity for BEMPEG in these two areas is quite significant. As a reference, combined Updivo and Keytruda sales in this setting are approximately $2 billion. We're excited to share these updated results from the PIVIT-O2 melanoma patients next week at CITSE. We continue to be impressed with the efficacy benefit demonstrated by BEMPEG plus NEVO in this study. And we maintain great optimism as we await the phase three data readout. Our ultimate goal with BEMPEG plus NEVO is to establish a new treatment paradigm in melanoma for the betterment of patients. And Nectar will host an analyst event on November 11th with key oncology experts to discuss these data, as well as our additional SITC presentations. And we hope you'll join us for that discussion. We've also recently initiated a second Phase 1-2 study of Nectar 255, our IL-15 program, and the next cytokine in our pipeline. The new trial will evaluate Nectar 255 in patients with solid tumors. This adds to the ongoing Phase 1 study for Nectar 255 in patients with non-Hodgkin's lymphoma and multiple myeloma. As a reminder, unlike other IL-15 approaches, Nectar 255 was designed to harness the full biology of the IL-15 pathway, meaning that Nectar 255 is specifically designed to capture all of the receptor ligand interactions available for targeting the IL-15 agonist pathway. We believe this gives Nectar 255 the ability to act as a significant expander of natural killer cells, as well as the ability to promote the survival and expansion of memory CD8 positive T cells. Natural killer cell agents are currently gaining great interest as this cancer cell killing mechanism is designed to boost and restore the immune response in patients, which can enable them to more effectively fight their cancer. For Nectar 358, we presented new data yesterday at the American College of Rheumatology Conference, and I know many of you listened to that presentation. Most notably, we observed a dose-dependent increase in T regulatory cells in lupus patients treated with Nectar 358. with a corresponding order of magnitude of reduction in disease symptomology. In Q3, Lilly started a phase two study in patients with lupus and they are also planning a second phase two study in patients with ulcerative colitis. These are in addition to Lilly's two ongoing phase one B studies of Nectar 358 in atopic dermatitis and psoriasis. Nectar 358 is a first in class investigational Treg stimulating agent which is designed to correct an underlying immune imbalance in patients with autoimmune conditions, many of whom experience reduced numbers and impaired function of their own T regulatory cells. We are very pleased that Lilly is advancing Nectar 358 and we look forward to the continued expansion of this development program. As all of you know, we continue to navigate the evolving COVID-19 landscape and I'm very proud of our employees who are working hard to ensure the least amount of interruption to our business. To that end, I'm pleased to report that we remain largely on track with our previously discussed trial timelines that were reviewed on our August financial results call. As I stated earlier, we remain highly focused on the five ongoing registrational oncology studies with BEMPEG plus Novolumab. These are the first in line metastatic melanoma study, the first line bladder cancer study, the first line renal cell carcinoma study, and the muscle emblazoned bladder cancer study, and the adjuvant melanoma study. We will provide a thorough review of the entire BEMPEG Registrational Program momentarily, but I'd like to mention a few timeline highlights from the Registrational Program for the Propel study in non-small cell lung cancer. We now have three Registrational Studies for BEMPEG, where we can see our first data readouts in the same timeline. These are the metastatic melanoma study, the cisplatin and eligible bladder cancer study, and the metastatic RCC study. For the metastatic melanoma study, which is being run by BMS, as we previously stated last quarter, because of COVID-19 delays in that study, we expect to report the first data in late 2021 or early 2022. The study has three endpoints, ORR, PFS, and OS. These are sequential endpoints. and PFS is the endpoint designed to support a full approval. For the bladder cancer study, we expect a similar timeline reporting ORR and the duration of response in the first part of 2022. And for RCC, we expect to get our first interim analysis for overall survival around the same time. In non-small cell lung cancer, we are actively enrolling patients into the ongoing PROPEL study of BEMPEG plus Merck's Pembrolizumab, which is the established standard of care in this setting. These data will inform our strategy for a registrational program for BEMPEG and first-line non-tumor cell lung cancer. And there's been a significant investigator interest in this study. And as a result, we've seen a recent increase in patient enrollment. We now expect that we will have preliminary ORR data in the first part of 2021 for approximately 30 patients with a minimum of two scans on treatment from the non-small-cell lung cancer cohorts of this study. You'll recall that our original thought was that we would have data available for only 10 to 20 patients, so we're very pleased with the speed of enrollment. We ended the third quarter with a strong balance sheet with over $1.2 billion in cash and investments and no debt. Our strong financial position allows us to focus on advancing our pipeline of autoimmune oncology candidates including lead cytokine programs IL-2 and IL-15 which have broad applicability in a wide range of tumor types. And I will now turn over the call to Wade to review the BEMPEG development program in more detail.