Nektar Therapeutics

Good day, and thank you for standing by. Welcome to the Nectar Therapeutics Second Quarter 2021 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 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. Jennifer Ruddick, Head of Corporate Affairs. 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, Gil Labroucherie, our COO and CFO, Dr. Jonathan Zaleski, our Chief of Research and Development, and Dr. Dimitri Noyton, our new Chief Medical Officer. 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, financial guidance and certain other statements regarding the future of our business. Because 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. Our actual results may differ materially from these statements. Important risks and uncertainties are set forth in the Form 10-Q that was filed on May 7, 2021, 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 the call over to Howard, I'd like to remind you again that since we're dialing in from different locations, I will moderate 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?

Howard Robin Thank you, Jennifer, and thanks, everyone, for joining us on the call today. You know, since the beginning of this year, we've continued to advance our deep portfolio in immuno-oncology and immunology, setting the stage for a steady cadence of key data readouts starting in the second half of this year. that will continue through the first half of 2022. These datasets are poised to provide us with the platform for a series of BLA filings and commercial launches of BEMPEG across multiple frontline solid tumor indications. Each of the investigational candidates in our pipeline, BEMPEG, NECTAR-255, and NECTAR-358, provide us with our own distinct value and broad development potential, and collectively, our clinical pipeline represents one of the most diverse and leading cytokine portfolios in development, a testament to our pioneering work in targeting cytokine biology and designing cytokine conjugates. Behind our clinical portfolio, we continue to invest in the area of immune science and cytokine biology to drive the next wave of IMD candidates. From an operational perspective, we entered the third quarter of 2021 with an exceptionally strong balance sheet, with over $1 billion in cash and no debt. Our strategic collaborations offer significant funding support for certain trials, and in the case of our collaboration with BMS, provide for a potential $1.4 billion in filing and approval milestones for BEMPEG in the U.S., Europe, and Japan. And as a reminder, these milestones are tied to any approval of BEMPEG, whether the approval is in combination with NEVO or not. So let me begin today with BEMPEG, our most advanced clinical program in IL-2 pathway agonists that is being developed in combination with checkpoint inhibitors NEVO and PEMBRO in multiple large frontline and adjuvant tumor settings. Throughout our partnership with BMS, we have five ongoing registrational studies of BEMPEG with NEVO that are proceeding nicely. We're uniquely positioned with three registrational studies for BEMPEG, which are expected to read out in the first half of 2022. These are the phase three study in metastatic melanoma, the phase three study in renal cell carcinoma, and the phase two accelerated approval study in PD-L1 low cisplatin ineligible bladder cancer. Also ongoing with our partner BMS are two additional large phase three studies, one in adjuvant melanoma and one in muscle invasive bladder cancer. Both indications offer an opportunity to expand the patient populations in melanoma and bladder cancer and could potentially benefit patients earlier in those diseases from treatment with BEMPEG. In addition, BMS is conducting a Phase II study in renal cell carcinoma for BEMPEG plus NEVO with a TKI to pave the way for future development of a TKI-inclusive regimen, building on their recent successful approval of NEVO plus CAVO. In terms of our strategy for BEMPEG plus PEMBRO, our first priority is to focus on the largest settings where PEMBRO is the gold standard of care, non-small cell lung cancer and head and neck cancer. And where we have the ability in that setting to combine BEMPEG with PEMBRO and run a comparative study against monotherapy PEMBRO designed for registrational purposes. We look forward to reporting data from our phase two PROPEL study and non-small-cell lung cancer later this year, which will help inform our registrational strategy for the doublet either with or without chemotherapy in non-small-cell lung cancer. While PEMBRO has improved overall survival in patients with non-small-cell lung cancer, its benefit is still limited to two years or so, and so we believe there's an opportunity to increase the treatment benefit in multiple regimens while also offering a chemo-sparing regimen in this tumor setting. We've also made excellent progress as we prepare to launch our Phase 2-3 study of PEMBRO and BEMPAG in head and neck cancer. We're ahead of schedule and now expect the study to be open for patient enrollment within the next few months. We're excited about the potential of this doublet to increase and deepen responses versus PEMBRO alone in this cancer, which has been shown to be immune-sensitive. PEMBRO has about 75% of the market share in the first-line setting for treatment of head and neck cancer, and with several recent Phase III failures in this setting, we are particularly encouraged by the potential of this doublet, the leading checkpoint inhibitor combined with our unique IL-2 mechanism. An equally compelling opportunity for us in the earlier stages of development is our second immuno-oncology candidate, Nectar 255, an IL-15 agonist, which has demonstrated its ability to expand natural killer cells, CD8 T cells, and memory T cells. Given these unique attributes, Nectar-255 could address even more tumor types than BEMPEG, including both liquid and solid tumors. We have a robust development plan in place, focused first on combining Nectar-255 with antibodies that use antibody-dependent cellular cytotoxicity, or ADCC, to kill cancer cells as these antibodies require functional NK cells for their mechanisms of action. We know that long-term expansion of natural killer cells through an IL-15 mechanism can greatly enhance the activity of these ADCC agents. We have two ongoing studies, one in solid tumors with cetuximab focused on colorectal cancer and head and neck cancer, and one in liquid tumors with rituximab focused on non-Hodgkin lymphoma, and with daratumumab focused focused on multiple myeloma. We look forward to providing data updates from these studies at medical meetings later this year. The third cytokine in our portfolio is Nectar 358, which is being developed in autoimmune disease in partnership with Eli Lilly to address a broad range of autoimmune inflammatory conditions. Nectar 358 targets the IL-2 receptor complex in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, Nectar-358 may bring the immune system back into balance. While we have seen recent activity in the Treg mobilizing pipelines, for example, Merck's recent acquisition of Pandion Therapeutics, Lilly is the clear leader in this space in respect to both the broad scope of development and the advanced clinical stage of the Nectar-358 program. and we're the only company to have reported a multiple-dose effect of our agent onto regulatory cells in patients. As was planned from the outset of our collaboration with Lilly, the development program, including manufacturing, has now transitioned over to Lilly. Lilly now has four Nectar 358 clinical studies underway, a 280-patient placebo-controlled Phase II study in lupus, a 200-patient placebo-controlled Phase II study in ulcerative colitis, and two ongoing separate Phase 1B studies in psoriasis and ectopic dermatitis. We expect data readouts from these Lilly Run studies over the next six to 18 months, and there are plans for future Phase 2 studies to be added to the program in the near future. I want to take a brief moment here to introduce our new chief medical officer, Dr. Dimitri Noitin, who joined Nectar last month. We are fortunate to have Dimitri on board at this exciting time for the company, He brings to Nectar extensive clinical development experience in immuno-oncology that will be valuable as we advance our pipeline. While at Pfizer, he designed and led the successful Javelin Bladder 100 study, which resulted in U.S. and European approvals for Avilamab in first-line maintenance setting for patients with bladder cancer. Dimitri will oversee our clinical strategy and activities, including direct supervision of clinical sciences, clinical operations, data science and systems, medical affairs, and clinical pharmacology. And we look forward to his leadership as we execute our robust development programs from BEMPEG and Nectar 255. So I'd like to turn it now over to Dimitri. Dimitri?