Protagonist Therapeutics (PTGX) Jefferies 2024 Global Healthcare Conference summary

Key business and pipeline updates

• Two advanced clinical assets: JNJ-2113 (partnered with J&J) and rusfertide (partnered with Takeda), both progressing in late-stage trials.

• JNJ-2113 is in multiple phase III studies for psoriasis and other indications, with timelines accelerated due to strong enrollment and partner enthusiasm.

• Rusfertide phase III enrollment completed; primary endpoint data expected by end of year, with results to be shared in Q1 next year.

• Partnership with Takeda includes significant milestone payments and a flexible opt-in/opt-out commercialization structure.

• Cash position exceeds $600 million, supporting operations through 2027 and enabling continued R&D investment.

Rusfertide clinical and commercial outlook

• Rusfertide targets polycythemia vera, addressing unmet needs in patients with uncontrolled hematocrit despite standard therapies.

• Phase III design closely mirrors successful phase II, with placebo arm from day zero and 32-week primary endpoint.

• Carcinogenicity study to complete by year-end, informing risk assessment alongside efficacy data.

• Decision on commercialization approach will be data-driven, weighing opt-in co-commercialization versus opt-out milestone and royalty structure.

• Long-term safety and efficacy data, including patient retention and symptom improvement, are key focus areas.

JNJ-2113 program and market potential

• JNJ-2113 is the first oral IL-23 blocker, with potential to disrupt the psoriasis and IBD markets.

• J&J is conducting six clinical studies, including head-to-head trials against Sotyktu, and expanding into rare psoriasis subtypes.

• Timelines for all studies have been positively revised, with phase IIb UC data now expected in Q4 this year.

• J&J estimates $5 billion+ annual sales potential for JNJ-2113.

• Communication of results will be coordinated with J&J, ensuring timely and transparent updates.