Protagonist Therapeutics, Inc.
Protagonist Therapeutics, Inc. Q1 FY2020 earnings call
May 13, 2020 · fiscal period ended 2020-03
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2020-05-13
Management highlights
- Protagonist started 2020 with 3 clinical assets from peptide technology platform. - PTG-300 is in Phase II open-label proof-of-concept studies for multiple blood disorders. - Initial robust clinical data from PTG-300 in polycythemia vera led to prioritization of PV for pivotal study based on clinical data strength, regulatory path, and commercial opportunity. - Priorities: advance PTG-300 in polycythemia vera and hereditary hemochromatosis, advance PN-943 to Phase II in ulcerative colitis, continue Phase II development of PTG-200 in Crohn's disease with Janssen. - Extended cash runway by 6 months by focusing on PV and HH, managing operating costs. - Suspended guidance for PN-943 Phase II initiation and PTG-200 Phase II data due to COVID-19, prioritizing health and safety of employees and study participants.
Segment performance
Protagonist has 3 clinical assets discovered via peptide technology platform. PTG-300 is in Phase II studies for various blood disorders (beta-thalassemia, polycythemia vera, hereditary hemochromatosis, myelodysplastic syndrome). Oral GI-restricted targeted peptide PTG-200 is in Phase II development with Janssen for Crohn's disease, and PN-943 is for inflammatory bowel disease. PTG-300 is prioritized for polycythemia vera based on robust clinical data, favorable regulatory path, and commercial opportunity. Revenue contribution details not explicitly provided in terms of percentages, but focus is on advancing PTG-300 in PV and HH, PN-943 in UC, and PTG-200 with Janssen.
Guidance
- Plan to submit additional data from PTG-300's polycythemia vera study at upcoming medical meetings. - Working with thought leaders to design pivotal study for PV, will engage with FDA to finalize. - Enrollment in PV study ongoing, expect more data updates in the last half of the year. - Focus on advancing PTG-300 in PV and HH as key priorities.
Risks
- Impact of COVID-19 on local operations and global activities, potentially affecting timelines for PN-943 and PTG-200. - Uncertainty regarding spleen size reduction in polycythemia vera patients, as animal model data on splenomegaly reduction not fully recapitulated in human patients yet.
Q&A highlights
Q: Chris Marai from Nomura Instinet asked how PTG-300 may fit in clinical practice for PV relative to drugs like Jakafi.
A: Ronald Hoffman responded that PTG-300 could be widely used, ideal for young patients to avoid life-long myelosuppressive therapy, and could be an adjunctive agent to eliminate phlebotomy needs.
Q: Gobind Singh asked about dosing in PV and discontinuation of MDS study.
A: Samuel Saks said once-weekly dosing in PV has been adequate so far; Don Kalkofen stated the MDS study was discontinued due to focus on PV's strong results.
Q: Joe Schwartz asked about blood components and mechanism.
A: Ronald Hoffman discussed platelet and reticulocyte changes, noting hematocrit is the biggest factor in thrombotic risk, not platelet count.
Q: Chris Bialas asked about discontinuing beta-thalassemia study.
A: Dinesh Patel explained focus shift to PV due to its outstanding data, with beta-thal data to be presented at upcoming medical conference.
Key numbers
Reported versus consensus
Earnings calendar feed
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Transcript
May 13, 2020Full transcript unavailable for redistribution
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