Nektar Therapeutics

Good day and thank you for standing by. Welcome to the Nectar Therapeutics third 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'll need to press star and then one in 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 all for joining us today. With us on the call are Howard Robin, our President and CEO, Gil Laboucherie, our COO and CFO, Dr. Jonathan Zaleski, our Chief of Research and Development, and Dr. Dimitri Noyton, our Chief Medical Officer. On today's call, we expect to make forward-looking statements regarding our business, including clinical trial enrollments and clinical trial results, timing and plans for future 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 these 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 August 6, 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 that we are dialing in from different locations. I will moderate the Q&A session for our team so we can avoid technical issues during the session, and 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, Jennifer. Thanks to all of you for joining us today. This quarter, we continue to advance both our IO and immuno-oncology pipeline. Our progress has set the stage for what is expected to be a transformative period for Nectar, starting with a series of anticipated key registrational, and key mid-stage data readouts across our portfolio throughout 2022, with the most anticipated data from our Phase III study for BEMPAG in melanoma coming in the early part of 2022. So let me begin today with BEMPAG, our most advanced clinical program. Our IL-2 pathway agonist is being developed in combination with checkpoint inhibitors NEVO and PEMBRO in multiple large frontline and adjuvant tumor settings. Together with our partner BMS, we're advancing five ongoing registrational studies of BEMPEG and NEVO under our joint development plan. Three of these studies are on track for top line data readouts in the first half of 2022. In October, BMS informed us that they completed enrollment in the phase three study of BEMPEG plus NEVO in previously untreated metastatic melanoma. The current forecast for timing for the ORR and PFS analysis from this study is sometime in the early part of 2022. Additionally, we anticipate data from the Phase III study in renal cell carcinoma and the Phase II accelerated approval study in cisplatin-ineligible bladder cancer in the first half of 2022 after the melanoma top-line data. Positive data from these three studies would support a series of BLA filings for BEMPEG, followed by commercial launches for the combination treatment of BEMPEG plus NEVO, beginning as early as late 2022 or early 2023. The registration program with BMS also includes two additional large Phase III studies, one in adjuvant melanoma and one in muscle-invasive bladder cancer. These indications offer an opportunity to significantly expand the patient populations that can be served by BEMPEG and to potentially benefit patients by treating them earlier in the course of their disease. We're particularly excited about the adjuvant melanoma study which is ahead in its enrollment projections with almost half of the target enrollment of 950 patients reached as of the beginning of November. These studies have longer timelines associated with them as they are in earlier settings with larger target enrollment sizes Data from these studies are expected beginning in 2024. In addition, BMS is conducting a phase two 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 CABA. In addition, we also have a sixth registration program which is a combination study of BEMPEG plus PEMBRO in head and neck cancer. The Phase 2-3 study in head and neck cancer is now enrolling patients. We're excited about the potential of this doublet to increase and deepen responses versus PEMBRO alone in this immune-sensitive cancer. PEMBRO has about 70% of the market share in the first-line setting for treatment of PD-L1-positive head and neck cancer patients, And we believe there is a unique opportunity to improve outcomes by combining our IL-2 mechanism with the leading checkpoint inhibitor in this setting. As we stated in the past, our initial strategy with MPEG, in combination with PEMBRO, is centered on the largest settings where PEMBRO is the gold standard of care. It had neck cancer, as I just described. And then in non-small cell lung cancer, we are running a phase two study called PROPEL. For the PROPEL study, we plan to present the initial data from the phase two study at the ESMO-IO meeting in December, and Dimitri will provide an update on this study on this call. These initial data will include approximately 60 to 70 patients treated with BEMPEG plus PEMBRO, doublet, with varying PD-L1 expression levels. At ESMO-IO, we will host an analyst call with Dr. Daniel Johnson of the Ochsner Medical Center in Louisiana, and I will let Dimitri talk more about this upcoming presentation in a moment. We've now advanced the PROPEL study with the addition of chemotherapy arms to the BEMPEG plus PEMBRO treatment regimen in both squamous and non-squamous patients with PD-L1 expression levels under 50%. The combination with chemotherapy allows us to consider a registrational strategy for BEMPEG in non-small cell lung cancer in these populations that currently have the highest unmet need for better therapeutic options. As you know, non-small cell lung cancer is not as immune sensitive a tumor as melanoma. So the chemotherapy combination with PEMBRO has emerged as a standard of care for these patients in order to overcome this more immune resistant setting. In particular, the under 1% patient population is one that we are highly focused on as a future potential registrational strategy for PEMPEG because of its mechanism of upregulation of PD-L1 in combination with a checkpoint and its ability to potentially increase depth of response and duration of response, which we know could lead to longer survival. Additionally, while PEMBRO and chemotherapy has improved overall survival in PD-L1 negative patients with non-small cell lung cancer, its benefit is still limited to under two years. We've also made notable progress with our second immuno-oncology candidate, Nectar 255, an IL-15 agonist that has demonstrated its ability to expand natural killer cells, CD8-positive T cells, and memory T cells. Given these unique attributes, Nectar 255 could address treatment needs in both liquid and solid tumors. Our development plan is initially focused on combining Nectar-255 with antibodies that use antibody-dependent cellular toxicity, or ADCC, to kill cancer cells, as these antibodies require functional NK cells for their mechanism of action. Next week at CITSE, we will share our first early data from patients in the initial dose escalation cohorts of the ongoing Phase I solid tumor study, which is evaluating Nectar-255 plus Cetuximab in patients with either colorectal or head and neck cancer. We are still dose-gestalating in this study, but we are pleased that the data were selected as a late-breaking abstract, and we'll be hosting a conference call next Friday, November 12th at 12 noon Eastern time with Dr. Alan Tan from Rush Medical Center to review these data in more depth. We also announced today that data from the ongoing dose escalation stage of the phase one study in hematological both agencies were accepted for presentation at ASH in December as well. The pharmacodynamic data in the abstract released today shows a sustained increase in NK and CD8 positive T cells, but also a proliferative ability of these cells. We look forward to providing more details at ASH. In September, we announced our first collaboration for Nectar 255 with Merck KGA and Pfizer. The collaboration expands the program for Nectar 255 into its first comparative trial in an on-label indication for Merck KGA's Avilamab as maintenance therapy in bladder cancer. Unlike other approved anti-PD-L1s, Avilamab has shown in preclinical studies to induce lysis of tumor cells via the ADCC mechanism, So we and Merck are excited to explore its potential synergies when combining with an NK cell stimulator, such as Nectar 255. Merck will evaluate Nectar 255 plus Avilamab as part of the phase two javelin bladder medley umbrella trial. We're excited that Nectar 255 was chosen for this umbrella study, and it is the only IL-15 agent that will be included. Merck will be responsible for conducting the study, which is set to begin in the first quarter of 2022, and Nectar will supply Nectar 255. Jay Z will discuss the trial in more detail momentarily. The third cytokine in our portfolio is Nectar 358, which we are developing in partnership with Eli Lilly to address a broad range of autoimmune and inflammatory conditions. Nectar 358 targets the IL-2 receptor complex to stimulate proliferation of powerful inhibitory immune cells, known as regulatory T cells, and thereby bring the immune system back into balance. We are proud of this program and we're the only company to have reported a multiple dose effect of our target, of our agents on target T regulatory cells in patients. Together with our partner Lilly, we're leading in this space with the advanced clinical stage of NECTA 358 program and with respect to the broad scope of development being executed in parallel across multiple significant autoimmune indications. As planned from the start of our collaboration with Lilly, the development program, including manufacturing, has now transferred to them. Lilly currently has Nectar 358 clinical trials underway, four clinical trials underway, a Phase II study in lupus, a Phase II study in ulcerative colitis, and two ongoing separate Phase Ib studies in psoriasis and ectopic dermatitis. We expect data readouts from these Lilly-run studies over the next 6 to 12 months, And Lilly is also planning to add two additional phase two studies to the program in the near future. Beyond our deep clinical portfolio, we continue to invest in the area of immune science and cytokine biology to drive the next wave of IND candidates. From an operational perspective, we have an exceptionally strong balance sheet and expect to end the year with over $800 million in cash. This cash position, together with the support of our strategic collaborations and potential for up to $1.4 billion in regulatory approval and sales milestones for BEMPEG in the US, Europe, and Japan, provides us with the financial foundation to execute our robust development strategy. We're all eagerly awaiting the anticipation, with anticipation, the registrational study readouts for BEMPEG and melanoma, RCC and bladder cancer in the first part of next year. Let me now turn the call over to our Chief Medical Officer, Dr. Dimitri Knight. Dimitri?