Protagonist Therapeutics, Inc. · NASDAQ:PTGX
Protagonist Therapeutics — JP Morgan 42nd Annual Healthcare Conference (January 2024)
24 slides from Protagonist Therapeutics's conference presentation, Jan 16, 2024
Slide 1: JP Morgan 42nd Annual Healthcare Conference
1 JP Morgan 42 nd Annual Healthcare Conference Dinesh V. Patel, Ph.D. President & CEO January 09, 2024
Slide 2: Forward-looking Statements
Forward - looking Statements 2 This presentation and the accompanying oral presentation contain forward - looking statements made pursuant to the safe harbor pro visions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in thi
Slide 3: Core Competency Remains our Focus: Expertise in Peptide-based Medicines
Core Competency Remains our Focus Expertise in Peptide - based Medicines Potency Peptide Chemistry SAR, Leads Phage Libraries Hits Computational Vectrix, Clusters Vectrix ® Clusters 1 2 3 POTENCY Oral Stability Peptidomimetics GI Assays GI-Restricted Targeted GI absorption & delivery Systemic Availa
Slide 4: Product Pipeline: Multiple Assets with Multi-Billion Dollar Market Potential
Disc./Pre - Clinical Phase 1 Phase 2 Phase 3 Key Milestones ICONIC - LEAD Ph3, n~600 PACIFIC Ph2 Elevated Hct (>48%), n=20 REVIVE Ph2, n=70, 40 wk study + 3 yr OLE RUSFERTIDE Hepcidin Mimetic • Enrollment completion 1Q 24 • Completed; OLE ongoing • Completed 1 See clinicaltrials.gov NCT06095115 2 Se
Slide 5: Rusfertide Hepcidin Hormone Mimetic Addressing Unmet Needs in Polycythemia Vera
Rusfertide Hepcidin Hormone Mimetic Addressing Unmet Needs in Polycythemia Vera
Slide 6: Polycythemia Vera Disease Background
Myeloproliferative neoplasm characterized by excessive production of red blood cells ( RBCs) 1 Treatment goal is to control HCT <45% to minimize TEs, CV risks and death 3 • Elevated hematocrit ( Hct ) is a hallmark of the disease 2 Serious, chronic disease associated with increased thrombotic and ca
Slide 7: A Blood Disorder with Significant Unmet Medical Need
4 3 2 Polycythemia Vera 7 • Burdensome symptoms including fatigue and concentration problems 2, 3 A Blood Disorder with Significant Unmet Medical Need 4 Uncontrolled HCT is associated with higher rates of death from cardiovascular causes or thrombotic events 1 Real world data shows that up to 78% of
Slide 8: REVIVE Phase 2 Study Design
Dose Finding * Efficacy Evaluation * Randomized Withdrawal Open Label Extension 1 PART 1 (28 wks ; Wks 1 - 29) PART 2 (up to 12 wks ) PART 3 (52 wks 1 ) STUDY HIGHLIGHTS: • Phlebotomy dependent PV patients diagnosed as per 2016 WHO criteria • ≥3 phlebotomies in 6 months with or without concurrent cy
Slide 9: Rusfertide Met the Primary Endpoint of Efficacy
Part 2: Blinded Randomized Withdrawal, Weeks 29 - 41 9 • 69.2% subjects (18/26) responders* – 8 non - responders as per protocol definition - 3 fulfilled the phlebotomy eligibility criteria - 5 discontinued treatment per patient/investigator discretion - 7 out of 8 non - responders continued treatme
Slide 10: REVIVE Study: Safety and Exposure
Phase 2 REVIVE Study: Safety and Exposure 10 Rusfertide Was Generally Well Tolerated; No New Safety Signals with Longer Follow - up 1 The nature and extent of the SAEs observed in the REVIVE study is consistent with comorbidities anticipated in the PV population, including vascular events 2 - 5 and
Slide 11: Phase 3 VERIFY: Rusfertide vs Placebo in Patients With PV
Part 1a Double Blind ( Weeks 0 - 32) Dose Titration Primary Efficacy (Weeks 0 - 20) (Weeks 20 - 32) Part 1b Durability of Response (Weeks 32 - 52) Screening (Up to 4 Weeks) Phase 3 VERIFY: Rusfertide vs Placebo in Patients With PV Pathway to Potential Registration in the USA and Europe Phase 3 study
Slide 12: Potential Commercial Positioning for Rusfertide
Potential Commercial Positioning for Rusfertide Potential Therapy of Choice for Patients with Moderate Treatment Burden 12 Prevalent Patients in US 1 : ~160,000 Diagnosed & Treated Patients 2 : ~100,000 ~30% ~60% ~60,000 patients ~10% Low Moderate Treatment Burden High Komodo claims data 2016 - 2022
Slide 13: JNJ-2113: Oral IL-23 Receptor Antagonist Peptide
JNJ - 2113: Oral IL - 23 Receptor Antagonist Peptide Targeted Investigational Therapy for Psoriasis & Other IL - 23 Mediated Diseases
Slide 14: Protagonist-Janssen Oral IL-23R Antagonist Collaboration
Protagonist - Janssen Oral, IL - 23R Antagonist Collaboration 14 JNJ - 2113 highlighted as f irst - and best - in class targeted oral IL - 23 peptide antagonist 2 • "Unprecedented potential" across multiple indications: plaque psoriasis, psoriatic arthritis, IBD • $5B+ p otential peak year sales pro
Slide 15: JNJ-2113: Preclinical, Phase 1 and Phase 2b Data
JNJ - 2113: Oral, IL - 23R Peptide Antagonist 15 Preclinical, Phase 1 and Phase 2b Data Supportive of a Robust Clinical Development Program 1 1. ISID – Fourie A, et al. First - in - Class Oral Peptide Systemically Targeting the IL - 23 Pathway. Abstract presented at the Inter national Societies for
Slide 16: JNJ-2113 FRONTIER Phase 2b Plaque Psoriasis Study
JNJ - 2113 FRONTIER 1 Phase 2b Plaque Psoriasis ( PsO ) Study Adult Patients with PP N=255 Eligibility • Moderate – Severe PP Inclusion • BSA > 10% • PASI > 12 Primary endpoint • PASI > 75 at Week 16 Screening Treatment Safety Follow - up (4 Weeks) (Up to 4 Weeks) (Weeks 0 - 16) 25 mg QD LTE (FRONTI
Slide 17: JNJ-2113 Phase 2b FRONTIER Data
JNJ - 2113 Phase 2B Frontier 1 Data 37.2% 51.2% 58.1% 65.1% 78.6% 9.3% 25.6% 26.8% 51.2% 46.5% 59.5% 2.3% 11.6% 9.8% 25.6% 23.3% 40.5% 0.0% 0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0% 80.0% 90.0% 25 mg daily (n= 43) 25 mg twice daily (n= 41) 50 mg daily (n=43) 100 mg daily (n=43) 100 mg twice dai
Slide 18: Cross-trial comparison of response rates
79% 60% 41% 41% 11% NR 69% 44% 9% 67% 46% 33% 67% 44% 16% 81% 57% 29% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% % response rate JNJ-2113 Otezla Sotyktu TAK-279 Stelara Tremfya 1. Cross trial (not head - to - head) comparisons 2. J NJ2113 100 mg bid dose. Wk 16 endpoint (Placebo: PASI 75: 9.3%, PASI 90:
Slide 19: Royalty Milestones Status and Outlook 2024 and Beyond
Royalty Milestones Status and Outlook 2024 and Beyond $172.5M* $795M amount of total future development and sales milestones for which Protagonist remains eligible in upfront and development milestones have been achieved 6% to 10% upward tiering 10% at ≥ $4B net sales Upcoming Potential Milestones 1
Slide 20: Discovery Pipeline, Financial Outlook, Major Catalysts Ahead
Discovery Pipeline Financial Outlook Major Catalysts Ahead 2024 is a year of pipeline execution and strategic evolution for Protagonist
Slide 21: Oral IL-17 Peptide Antagonists
Oral IL - 17 Peptide Antagonists 21 • IL - 17 antagonists expected to be a leader in the I&I space – Global sales expected to increase significantly from ~$29B (2021) to >$50B (2031) for IL - 17 mediated indications 1,2 • Leveraging our oral peptide technology platform • Target product profile (TPP)
Slide 22: Financial Highlights
Financial Highlights Financial Resources Forecast Extends Through Q1 2026 CASH, CASH EQUIVALENTS & MARKETABLE SECURITIES provide forecast cash runway through Q1 2026* SHARES OUTSTANDING as of September 30, 2023 Q1 2026 ~57.6M CASH, CASH EQUIVALENTS & MARKETABLE SECURITIES as of September 30, 2023 22
Slide 23: Major Catalysts Ahead
2023 2024 2025 2026 Q4 Q1 Q2 Q3 Q4 ASH JNJ - 2113 Janssen Major Catalysts Ahead A Transformative Path Forward for Protagonist, from Discovery to Development to Commercialization Program Rusfertide in PV JNJ - 2113 Janssen Discovery & Pre - Clinical 2
Slide 24: Thank you
& Protagonist Therapeutics Thank you
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