8-K: Protagonist Therapeutics Presents Pipeline Progress at J.P. Morgan Healthcare Conference

Protagonist Therapeutics highlighted advancements in their pipeline, including Rusfertide for Polycythemia Vera and JNJ-2113 for psoriasis, at the J.P. Morgan Healthcare Conference.

Summary

• Protagonist Therapeutics presented at the 42nd Annual J.P. Morgan Healthcare Conference on January 9, 2024.
• The company's core competency is in peptide-based medicines, focusing on potency, stability, and oral availability.
• Key programs include Rusfertide, a hepcidin mimetic for Polycythemia Vera (PV), and JNJ-2113, an oral IL-23 receptor antagonist for psoriasis.
• Rusfertide has completed Phase 2 trials and is moving into Phase 3, with enrollment completion expected in Q1 2024.
• JNJ-2113 has shown positive Phase 2b results in psoriasis and is progressing through a comprehensive Phase 3 program.
• The company is also developing oral IL-17 peptide antagonists, with a development candidate expected in 2024.
• Protagonist has a collaboration with Janssen for JNJ-2113, with potential future development and sales milestones totaling $795 million.
• The company's financial resources are forecasted to extend through Q1 2026, including $60 million in milestones achieved in Q4 2023.

Sentiment

Score: 8

Explanation: The document presents a positive outlook with strong clinical data, a significant collaboration, and a clear path forward. The company's financial position is also strong, contributing to a high sentiment score.

Positives

• Rusfertide demonstrated a highly significant efficacy in the Phase 2 REVIVE study, with a p-value of 0.0003.
• JNJ-2113 showed strong dose-response data in the Phase 2b FRONTIER 1 study, with the 100mg twice daily dose achieving a 78.6% PASI 75 response rate.
• The company has a strong collaboration with Janssen, a leader in the I&I market.
• Protagonist has a robust pipeline with multiple assets targeting multi-billion dollar markets.
• The company's financial position is strong, with a cash runway extending through Q1 2026.
• The oral IL-17 peptide antagonist program is progressing, with a development candidate expected in 2024.

Negatives

• The document notes that some patients in the Phase 2 Rusfertide study discontinued treatment due to patient/investigator discretion.
• The document mentions that some serious adverse events (SAEs) were observed in the REVIVE study, although most were assessed as unrelated to rusfertide.

Risks

• Forward-looking statements are subject to risks and uncertainties, and actual results may differ materially.
• Clinical trials are subject to risks, including enrollment challenges and unexpected safety issues.
• The company's product candidates are still under clinical investigation and have not yet been approved for marketing by the FDA.
• The company is dependent on the success of its collaboration with Janssen for JNJ-2113.
• The company's financial forecast is based on certain assumptions and may be impacted by unforeseen events.

Future Outlook

Protagonist Therapeutics is focused on pipeline execution and strategic evolution in 2024, with key milestones expected for Rusfertide and JNJ-2113, as well as the advancement of their oral IL-17 program. The company anticipates potential NDA filings and product launches in the near future.

Management Comments

• The company's core competency remains expertise in peptide-based medicines.
• JNJ-2113 is highlighted as a firstand best-in-class targeted oral IL-23 peptide antagonist with unprecedented potential across multiple indications.
• The company is leveraging its oral peptide technology platform for the development of oral IL-17 peptide antagonists.

Industry Context

The presentation highlights the potential of oral peptide therapeutics in the I&I space, particularly in psoriasis and inflammatory bowel diseases. The company is positioning itself to compete with both injectable biologics and other oral agents in these markets. The collaboration with Janssen leverages a major player in the I&I space.

Comparison to Industry Standards

• The PASI 90 response rate of 59.5% for JNJ-2113 in the Phase 2b study compares favorably to other oral agents like Otezla (41%), Sotyktu (44%), and TAK-279 (46%) at their respective primary endpoints.
• The PASI 90 response rate of 59.5% for JNJ-2113 in the Phase 2b study is also competitive with injectable biologics like Stelara (2%) and Tremfya (2%) at their respective primary endpoints.
• Rusfertide's Phase 2 results show a significant improvement in hematocrit control compared to the standard of care for Polycythemia Vera, which often involves phlebotomy and cytoreductive therapies.
• The company is targeting a market of approximately 100,000 diagnosed and treated PV patients in the US, indicating a significant commercial opportunity for Rusfertide.

Stakeholder Impact

• Shareholders are likely to view the presentation positively due to the strong clinical data and financial outlook.
• Patients with Polycythemia Vera and psoriasis may benefit from the development of new treatment options.
• Employees may be motivated by the company's progress and future prospects.
• The collaboration with Janssen may provide opportunities for further growth and development.

Next Steps

• Enrollment completion for the Phase 3 VERIFY study of Rusfertide in Q1 2024.
• NDA filing for Rusfertide in PV in Q4 2024.
• Completion of the Phase 3 ICONIC-LEAD and ICONIC-TOTAL studies for JNJ-2113 in psoriasis.
• Completion of the Phase 2b ANTHEM study for JNJ-2113 in ulcerative colitis.
• Advancement of the oral IL-17 peptide antagonist program with a development candidate in 2024.

Key Dates

Keywords

Protagonist Therapeutics, Rusfertide, JNJ-2113, Polycythemia Vera, Psoriasis, Oral Peptide, IL-23, IL-17, Janssen, Clinical Trials, Hepcidin Mimetic, Phase 3, Milestones