Protagonist Therapeutics(US:PTGX)2019-03-13 02:16Financial Data and Key Metrics Changes - Protagonist ended 2018 with $128.9 million in cash and cash equivalents and investments, sufficient to fund operations through the end of 2020 [36] - The company reported a net loss of $13.9 million or a negative $0.57 per share for Q4 2018, compared to a net loss of $3.1 million or a negative $0.15 per share for the same period in 2017 [37] - License and collaboration revenue decreased to $2.4 million for Q4 2018 from $11.3 million in Q4 2017, primarily due to nearing the end of revenue recognition from a previous agreement [38][39] - R&D expenses increased to $14.2 million for Q4 2018 from $11.7 million in Q4 2017, driven by costs related to contract manufacturing and clinical trials [40] Business Line Data and Key Metrics Changes - The company has three distinct therapeutic candidates in development: PTG-300, PTG-200, and PN-943, all utilizing its proprietary peptide technology platform [7][11] - PTG-300 is the most advanced asset, targeting multiple blood disorders, with a global Phase 2 study initiated in beta-thalassemia patients [24] - PTG-200 is ready for a Phase 2 study in Crohn's patients, expected to be initiated by Janssen in the first half of 2019 [16] - PN-943 is currently in Phase 1 studies in healthy volunteers, with initial clinical safety and pharmacodynamic results expected in the first half of 2019 [33] Market Data and Key Metrics Changes - The company is focused on addressing unmet medical needs in rare diseases and inflammatory bowel diseases (IBD) through its peptide therapeutics [10][18] - There is a noted shift towards oral targeted therapies in IBD, with Protagonist's oral gut-restricted candidates positioned to meet this demand [18] Company Strategy and Development Direction - Protagonist is exclusively focused on peptide therapeutics, leveraging its proprietary technology to develop unique drug candidates that address specific medical challenges [9][10] - The company anticipates six key milestones for 2019, including results from the TRANSCEND study for PTG-300 and IND filings for PTG-200 and PN-943 [34][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial resources to support clinical development through 2020 and highlighted the potential for PTG-300 in multiple indications [20][36] - The management team emphasized the unique mechanisms of action of their drug candidates and the barriers to entry for competitors [11][19] Other Important Information - PTG-300 has received orphan drug designation and fast-track designation from the FDA, enhancing its development prospects [24] - The company has a strong partnership with Janssen for PTG-200, which is expected to enhance the Stelara franchise [16][28] Q&A Session Summary Question: Details on PTG-300 study and its efficacy in different patient types - Management provided insights into the trial design for PTG-300, focusing on safety and preliminary efficacy in both transfusion-dependent and non-transfusion-dependent beta-thalassemia patients [44][45] Question: Regulatory pathway for PTG-300 - Management indicated that once adequate safety data is obtained, they plan to propose a pivotal study to the FDA, with primary endpoints focused on anemia and transfusion burden [60][61] Question: Updates on PN-943 and its Phase 1 data - Management confirmed that the Phase 1 data will inform the design of the Phase 2 study for PN-943, with a focus on pharmacodynamic markers [65][72] Question: IND submission for PTG-200 - Management clarified that Janssen is responsible for filing the U.S. IND for PTG-200, with both teams collaborating closely on the clinical development [74][76] Question: Operating expense targets for 2019 - Management did not provide specific targets but indicated that they have sufficient cash to support operations through 2020 [85]