Nektar(US:NKTR)2019-11-07 02:52Financial Data and Key Metrics Changes - The company anticipates ending 2019 with approximately $1.6 billion in cash and investments [45] - Full year GAAP revenue guidance remains between $100 million and $110 million for 2019 [46] - Full year 2019 GAAP R&D expense is projected to range between $430 million and $450 million, including approximately $65 million of non-cash depreciation and stock compensation expense [46] - G&A expense for 2019 is projected to be approximately $100 million, which includes approximately $45 million of non-cash depreciation and stock compensation expense [47] Business Line Data and Key Metrics Changes - NKTR-181 is expected to have an advisory committee meeting scheduled by the FDA in the coming months, with preparations for its potential launch underway [9][11] - NKTR-358 is currently in clinical evaluation for three separate autoimmune disease conditions, with plans for a Phase 2b study in lupus in the first half of 2020 [12][13] - NKTR-255 has initiated its first-in-human clinical trial in patients with relapsed/refractory non-Hodgkin's lymphoma and multiple myeloma [15] Market Data and Key Metrics Changes - The company is focusing on five to six key registrational trials in collaboration with BMS, including studies in melanoma, urothelial cancer, and renal cell carcinoma [21][24] - The PROPEL study is evaluating the combination of bempeg with pembrolizumab in first-line non-small cell lung cancer [27][29] Company Strategy and Development Direction - The company is prioritizing the approval of bempeg and advancing its pipeline while maintaining a strong balance sheet [48] - Ongoing discussions with BMS aim to finalize the joint development plan for bempeg, with a focus on expanding its use in various cancer indications [20][72] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of NKTR-181 to address the opioid crisis and the progress of NKTR-358 in autoimmune diseases [10][12] - The company is excited about the prospects of NKTR-255 in oncology and virology, highlighting its unique mechanism of action [37][43] Other Important Information - The company has published significant data supporting its programs, including studies on NKTR-181 and NKTR-358 [10][14] - The PROPEL study will not include chemotherapy in its design, focusing solely on the immuno-oncology doublet [52] Q&A Session Summary Question: Can you remind us what the dose levels will be for the PROPEL study? - The study will evaluate two dose levels: 0.006 mg/kg and 0.008 mg/kg [51] Question: What is the commercialization rights situation with the PROPEL study? - Nektar and BMS will jointly market bempeg, retaining 65% and 35% of the profits respectively [54] Question: When can we expect the ORR data from the Phase 3 melanoma trial? - The ORR data could be available as early as Q4 of 2020 [57] Question: What are the updated thoughts on the bladder and RCC registrational trials? - Top line data for the bladder study is expected in mid-2021, while RCC data may come in late 2021 or 2022 [69] Question: Is there a trial being considered for muscle-invasive bladder cancer? - Yes, a confirmatory study for muscle-invasive bladder cancer is being considered [75]