Nektar Therapeutics

Ladies and gentlemen, thank you for standing by, and welcome to the Nectar Therapeutics first quarter 2020 financial results conference call. At this time, all participants' lines 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 then one on your telephone. Please be advised that today's conference may be recorded. If you require any further assistance, please press star 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 are Howard Robin, our President and CEO, Gil Labruchery, our COO and CFO, Dr. Jonathan Zalevsky, our Head of R&D, 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 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 these 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-K that we filed on February 28, 2020, which is available at sec.gov. We undertake no obligation to update any of these 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 NECTR's website at NECTR.com as a replay. Thank you very much, and we appreciate your patience as we work to ensure there are no technology disruptions for 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. I'd like to start the call by discussing what is certainly on everyone's mind, managing the challenging circumstances caused by COVID-19 in the past several months. So the wide range of impact that this virus has had on the health and well-being of our communities is significant. And like all of you, We're all working hard to appropriately adapt our business practices while at the same time leading and operating the business effectively. This is a dynamic situation and we will continue to adapt our response. However, I want to highlight a few key areas. As we start working, as we work together to navigate the current environment, we have three main priorities. First is to protect the health of our employees while continuing our essential operations on site to advance our research and development such as laboratory and manufacturing activities. Second, to ensure that each of our trial investigators and their teams can continue to provide superior care and uninterrupted access to study treatment to patients fighting cancer. And third, to ensure that the conduct of our clinical trials is minimally impacted and that the integrity and quality of data being collected from these studies are maintained. So to the first priority, for employees who continue to work on clinical tasks Thank you for joining us. At this time, we do not anticipate any supply interruptions for manufacturing, including our preparations for scale-up of commercial supply of BEMPEG that are underway. We have sufficient clinical trial material on hand to treat all patients in the studies for BEMPEG, Nectar 262, Nectar 255, and Nectar 358, which are either underway or planned to start in 2020. We and our manufacturing partners are continuing to regularly assess the situation as well. Additionally, our research team is continuing to work towards generating our next IND candidate so that we can achieve the company's next IND filing in early 2021. So the second priority, we have over 200 investigator sites around the world participating in our oncology clinical studies. We've been actively engaging with site investigators and our CRO partners in order to assess site status and staffing issues and to provide resources and support to these sites. Conditions are fluid and evolving. However, Nectar is taking a strategy to allow sites to continue to enroll new patients and to initiate new investigator sites. So far, this strategy has been successful and Wei will discuss more of these initiatives in a moment. Our third but equally important priority is to ensure the integrity and conduct of our clinical trials. This means capturing any protocol deviations if they arise during this time, carefully collecting any patient information which may be related to a COVID diagnosis, and being prepared to track any possible interruption of important treatment or scan visits related to COVID travel restrictions. The FDA has issued guidance on clinical trial conduct and we expect this guidance to continue to evolve. In light of this, the most important activities for us are to carefully monitor are study sites to ensure that patients meet the appropriate eligibility criteria under the protocol and that the data are being collected and tracked appropriately as well. Now, many of you have asked about the potential impact of clinical trial timelines related to COVID. We have some preliminary insights to share, but caution that because of the fluidity of the situation, there is significant uncertainty. We will therefore need to continually assess these timelines throughout the year, and we continue to get more visibility to the timing and extent of COVID impacts. Our Nectar clinical development and operations teams are highly focused during this time on the oversight of the five clinical studies in immuno-oncology where Nectar serves as a sponsor. The first-line bladder cancer study of BEMPEG plus NEVO, the first-line renal cell carcinoma study of BEMPEG plus NEVO, the PROPEL study of BEMPEG plus PEMBRO, the Nectar 262 reveal study with BEMPEG and the Nectar 255 studies. First, in response to some questions we've received, we've only had a few reports of patients in our studies who have had suspected or confirmed COVID diagnosis. For the five clinical studies that I just mentioned, as of today, we have received only four reports of patients who have been diagnosed with COVID. This is across our 200-plus investigator sites. With respect to new study starts, Nectar is still on track to initiate the adjuvant melanoma study in the third quarter. Based upon our assessment of the current situation, and barring any negative external COVID developments in the second half of the year, we believe this is very achievable. The protocol for the adjuvant melanoma study is now being finalized, and we are in the process of identifying and recruiting investigator sites for initiation later this year. With respect to the first-line bladder cancer study, we have not seen any impact on enrollment pace to date, and we expect to achieve our enrollment goal this summer. This means that we will meet the timeline of achieving primary endpoint for the study sometime in mid-2021. As a reminder, the primary endpoint in the study is ORR, independent review for patients with under 10 CPS score. For the first-line renal cell carcinoma study, we are on track for our projections for enrollment prior to COVID, which means we are also on track to achieve the first interim analysis on the primary endpoint of the overall survival in the first quarter of 2022. For our Propel study of BEMPEG plus PEMBRO in non-small cell lung cancer that was initiated late in 2019, enrollment is ongoing. The COVID situation delayed initiation for the investigator sites in Europe for Propel. However, we are still initiating some of these European sites in countries that are less impacted by COVID. But we are doing this very carefully and only with sites Thank you. Thank you. Thank you. Our Phase 1-2 reveal study is advancing. We recently expanded the study to evaluate the recommended Phase 2 dose of Nectar 262 in up to 24 relapsing refractory melanoma patients. We are now, for the first time, evaluating simultaneous dosing of the two investigational agents. In the dose escalation phase, we observed high levels of TLR activation in the tumor microenvironment and were able to characterize safety for Nectar 262. We're planning to submit these dose escalation data for potential presentation at a medical meeting or a manuscript publication later this year. For Nectar 255, our IL-15 agonist program, and our newest clinical candidate, we're actively enrolling patients into the first in human clinical study of Nectar 255, which began late last year. We're still initiating sites in this study and still have a goal to complete the dose escalation portion of the study by the end of this year. Of course, meeting this goal will depend upon how many dose cohorts we need to enroll before achieving a maximum tolerable dose. With the first several patients we enrolled into the study, we already have good biomarker evidence of target engagements of the IL-15 pathway, and we're planning to present these data later this year or early 2021. And as a reminder, the study is evaluating Nectar 255 first as a monotherapy, and then in combination with daratumumab or rituximab, and multiple myeloma and non-Hodgkin's lymphoma, respectively. Now I'll move on to discuss studies that are being run by our partners. As many of you have likely listened to the conference calls from large pharmaceutical companies over the past several weeks, management practices around ongoing and planned clinical trial activities have varied during the COVID situation. Many companies are projecting that normal practices for clinical trial activities in most countries will resume in the second half of 2020. In general, this has meant adjustment of timelines for studies of anywhere from three to six months. Each of our partners has deployed different methodologies. With respect to our partner, BMS, during the ongoing COVID situation, BMS has publicly stated that they have paused initiation for all new investigator sites in any clinical study they are conducting across the company. BMS is running two ongoing BEMPEG clinical studies, currently the first-line melanoma study and the muscle invasive bladder cancer study. As you know, BMS is operationalizing these studies and managing these studies' timelines. BMS continues to recruit patients for these studies at investigator sites that are allowing on-site monitoring for new patients. At this time, because the COVID situation is ongoing and BMS has not reprojected any study timelines, Nectar expects this will have an impact on the enrollment for both studies, which could translate into delays of three to six months. We are now working closely with BMS to determine when BMS will remove or modify any restrictions that impact enrollment. Also as a reminder, we received a $25 million milestone payment in the first quarter of this year under the revised BMS agreement for the start of the muscle invasive bladder cancer study for BEMPEG plus NEVA. BMS is also planning to start later in the year for the TKI combo renal cell carcinoma study and the phase two study of BEMPEG plus NEVO in first line non-small cell lung cancer. With respect to our partner Lilly and Nectar 358, our Treg stimulatory program, the phase one multiple dose studies in psoriasis and atopic dermatitis have temporarily suspended recruitment during the COVID situation. However, Lilly is continuing to assess the situation and evaluating the status of investigator sites to determine when the best time is to reopen these studies for patient recruitment. We're still anticipating two phase two studies to be initiated by Lilly this year, one in lupus patients and one in an additional autoimmune disease state. Both are slated to start in the second half of 2020. We know that the team at Lilly is evaluating all options to start these studies, including focus on initiating investigator sites in countries with low impact or minimal current impact from COVID. And so we appreciate their dedication to creatively finding paths forward to initiate these new studies. Overall, we're very pleased with Lilly's continued commitment to Nectar 358, as well as the broad plans for its development, which reflect the potential of this novel mechanism to treat autoimmune disease. And before I hand the call over to Wei, I'd like to mention several additional data presentations we're planning for this year. First, for the melanoma cohort for PIVOT-02, As many of you know, last year we obtained FDA breakthrough therapy designation for BEMPEG plus NEVO in patients with metastatic melanoma based on the positive data, including a high CR rate from our PIVIT-O2 study. At CINCI last year in November, we presented data from this cohort with a median follow-up of approximately 18 months. At that time, 34% of patients had a complete response as determined by blinded independent central review, 42% had a 100% reduction in target lesions, and 47%, almost half, had a greater than 75% reduction in target lesions. We recently completed an additional blinded review of the Pivot02 melanoma cohort at the end of December 2019, and this data cut added three additional months of follow-up from our prior CITI presentation, and I'm pleased to inform you today that at the 21-month median follow-up point, We have still not achieved median PFS for the patients in this cohort. We also continue to see deepening of responses for these patients, and we plan to present updated data from an even later data cut at the CITSE 2020 meeting. Also, for BEMPEG data from the dose escalation portion of PIVOT-02, it will be recognized in a publication at a canceled journal in May. And finally, we are planning to submit for publication additional manuscripts for the bladder and kidney cancer patient cohorts from PIVIT-02. For NECTAR-358, we recently completed the phase 1B multiple ascending dose study in lupus patients that NECTAR conducted as part of our Lilly collaboration. And the initial data from this phase 1B study were accepted for presentation at the upcoming virtual ULARC conference. We also intend to present additional data from the same study at the 2020 American College of Rheumatology meeting, ACR, later this year. With that, I'll turn the call over to Wade to review in more detail some of the techniques we're deploying across the Nectar-run clinical trials to address the COVID situation and to ensure the integrity and conduct of the studies during this challenging time. Wade?