Protagonist Therapeutics (NasdaqGM:PTGX) FY Conference Transcript

Summary of Protagonist Therapeutics FY Conference Call Company Overview - Company: Protagonist Therapeutics (NasdaqGM:PTGX) - Key Focus: Development of innovative therapeutics, particularly in the areas of polycythemia vera (PV) and inflammatory bowel disease (IBD) Key Points and Arguments Drug Development and Breakthrough Designation - Protagonist Therapeutics is on the verge of obtaining approval for its first two drugs, with resveratide for polycythemia vera recently receiving breakthrough designation, indicating the FDA's confidence in its efficacy and safety [2][8][9] - The company achieved significant phase three results, meeting primary and secondary endpoints, including patient-reported outcomes, which are critical in the treatment of PV [6][7] - The breakthrough designation allows for expedited review, with an expected NDA filing by the end of the year and potential approval within a year, contingent on priority review [11][12] Market Opportunity in Polycythemia Vera - The prevalence of PV in the US is over 150,000 patients, with approximately 70% receiving treatment; however, two-thirds of these patients struggle to maintain hematocrit levels below 45% [13][14] - Protagonist estimates a market opportunity of $1 to $2 billion for resveratide, with a target population of around 50,000 patients who could benefit from the drug [15] Opt-In/Opt-Out Decision - The company is evaluating whether to opt in or out of a partnership with Takeda, with a potential opt-out fee of $400 million and higher milestone payments if they choose to opt out [19][20] - The decision will be made by mid-next year, with the NDA filing influencing the timeline [19] Oral Hepcidin Development - Protagonist is also developing an oral hepcidin, which is distinct from resveratide but related mechanistically; the company aims to explore its utility beyond PV [29][30] ICO and IBD Market - ICO, another key asset, has filed for NDA for psoriasis, with expectations for approval in July next year; it is the only oral IL-23 blocker, presenting a significant opportunity in both dermatology and IBD [31][32] - The phase two data for ICO in ulcerative colitis (UC) shows a 30% clinical remission rate, indicating strong potential in the IBD market [36][37] Differentiation in Obesity and Other Areas - Protagonist acknowledges the crowded obesity market but emphasizes differentiation through their unique oral GLP-1/GIP/GCG platform [41][42] - The company is developing both oral and subcutaneous formulations to cater to different patient preferences [45] Future Directions - Protagonist is committed to investing in internal R&D and exploring external innovations to strengthen its platform and pipeline [22][23] - The company is optimistic about the potential of its assets in both the PV and IBD markets, with ongoing clinical studies and strategic partnerships [50] Additional Important Insights - The company is focused on maintaining a strong cash position while exploring various avenues for growth, including potential buybacks and investments in new technologies [25][26] - Protagonist's approach to drug development emphasizes the importance of clinical data and market feedback, which shapes their strategic decisions [9][15]