Protagonist Therapeutics(PTGX) - 2019 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Protagonist reported a net loss of $77.2 million for the full year of 2019, compared to a net loss of$38.9 million for 2018, and a net loss of $17.5 million for Q4 2019, compared to a net loss of$13.9 million for Q4 2018 [32] - License and collaboration revenue for the full year of 2019 was $0.2 million, significantly down from$30.9 million in 2018, primarily due to a one-time cumulative adjustment related to revenue recognition principles [33] - Research and development expenses were $65 million for the full year of 2019, up from$59.5 million in 2018, while general and administrative expenses increased to $15.7 million from$13.7 million in the previous year [34][35] - Protagonist ended 2019 with $133 million in cash, cash equivalents, and marketable securities, with access to a debt facility of$10 million, sufficient to fund operations through the end of 2021 [36] Business Line Data and Key Metrics Changes - The company has three clinical assets in development: PTG-300 for blood disorders, and PTG-200 and PN-943 for inflammatory bowel diseases (IBD) [11] - PTG-300 is being pursued in four different indications, with ongoing studies expected to yield data-driven decisions in 2020 [13][20] - PTG-200 has progressed into a Phase II clinical proof-of-concept study in Crohn's disease, with results expected in the first half of 2021 [22] - PN-943 is set to initiate a Phase II study in ulcerative colitis in Q2 2020, with topline efficacy results anticipated in the second half of 2021 [25] Market Data and Key Metrics Changes - The company has expanded its collaboration with Janssen, resulting in milestone payments and the nomination of a second-generation development candidate [22][23] - The competitive landscape for ulcerative colitis trials is noted, with Protagonist confident in the advantages of its drug offerings [54] Company Strategy and Development Direction - The company aims to evaluate PTG-300 in multiple indications and select the first indication for a pivotal study in 2021 [28] - Continued collaboration with Janssen for the development of PTG-200 and exploration of second-generation oral IL-23 receptor antagonists is a priority [28] - Advancing PN-943 in a Phase II study is also a key focus, with the potential for significant impact in the IBD treatment paradigm [26][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing studies and the potential impact of the coronavirus outbreak on operations, stating that guidance on objectives and timelines remains unchanged [30] - The company is encouraged by progress made in 2019 and looks forward to multiple data-driven decisions in 2020 [87] Other Important Information - The company has strengthened its team and extended its cash runway through the end of 2021, allowing for continued clinical development [9][27] Q&A Session Summary Question: Update on PTG-300 and exploration in non-transfusion-dependent patients - Management confirmed that both transfusion-dependent and non-transfusion-dependent populations are being pursued, though enrollment in the latter is slow [39] Question: Potential for multiple indications for PTG-300 - The focus is currently on selecting the first indication for a pivotal study, with the possibility of pursuing multiple indications in the future [42] Question: Timing for TRANSCEND data announcement - Management indicated that definitive data, including clinical responders, would be shared in 2020 as conclusions are reached [49] Question: Improvement of PN-943 over PTG-100 - PN-943 was found to be roughly threefold more effective than PTG-100 based on preclinical and Phase I studies [50] Question: Competition for ulcerative colitis trials - Management acknowledged competition but expressed confidence in the advantages of their drug, including proven targets and a GI-restricted approach [54] Question: Dosing strategy for PTG-300 - Management stated that while the current focus is on 40 mg twice-weekly dosing, there is flexibility to explore higher doses if necessary [58][61] Question: Lessons learned from PTG-100 study for PN-943 - Management highlighted the importance of addressing high placebo effects and maintaining close communication with key opinion leaders in the IBD community [64] Question: Future Phase II study design for PN-943 - The upcoming Phase II study will be designed to gather sufficient information for potential pivotal study preparation [68]