Kyntra Bio, Inc. · NASDAQ:KYNB
Kyntra Bio — Fibrogen — Investor Presentation (January 2018)
36 slides from Kyntra Bio's investor presentation, Jan 8, 2018
Slide 1: Corporate Presentation January 2018
Corporate Presentation January 2018 Exhibit 99.1
Slide 2: Forward-looking statements
This presentation, the accompanying modules, and in each case the oral commentary contain “forward-looking” statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, the accompanying modules, and in each case
Slide 3: 2017: A Great Year - Clinical
2017: A Great Year Pamrevlumab Idiopathic Pulmonary Fibrosis Positive topline Phase 2b data reported, and presented at ERS Pancreatic Cancer Promising interim topline Phase 2 data Roxadustat Anemia in CKD (dialysis-dependent and non-dialysis dependent) Positive Phase 3 results reported from two Phas
Slide 4: 2017: A Great Year - Corporate and Financial
2017: A Great Year Corporate and Financial Strong and well-managed cash position Reported $762.7M cash balance as of September 30, 2017 Two successful financings $115.1M in net proceeds in April, supporting expansion of roxadustat beyond CKD in China $356.2M in net proceeds in August, supporting pam
Slide 5: FibroGen in 2018: Science, Pipeline, Partners
FibroGen in 2018 Science, Pipeline, Partners Two late-stage, first-in-class programs with multiple indications Multi-billion dollar anemia, cancer, and fibrotic disease markets Roxadustat is the leader in HIF-PHI therapeutics Significant clinical and regulatory catalysts anticipated for 2018 Partner
Slide 6: Product Portfolio
HIF-PHI PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Roxadustat for CKD Anemia United States, Europe China [NDA Submitted 10/17] Japan Roxadustat for MDS Anemia United States China1 Product Portfolio ANTI-CTGF PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Pamrevlumab Idiopathic Pulmonary Fibrosis Pancreatic Cancer Duc
Slide 7: Pamrevlumab: Fibrosis and Cancer
Pamrevlumab Fibrosis and Cancer
Slide 8: Pamrevlumab: Innovative Treatment for Fibroproliferative Diseases
Pamrevlumab ─ Innovative Treatment for Fibroproliferative Diseases in Fibrosis and Cancer Strong Phase 2 Clinical Data: PoC for both disease categories Poised for Pivotal Trials in IPF and Pancreatic Cancer CELLULAR RESPONSES FIBROSIS CANCER IPF DMD Cirrhosis Cardiovascular disease Target Diseases P
Slide 9: Pamrevlumab: Pursuing Three Indications With Unmet Medical Needs
Pamrevlumab: Pursuing Three Indications With Unmet Medical Needs IPF & Pancreatic Cancer: Preparing for Phase 3 Completed Phase 2 in advanced disease (n=75) Positive exposure response relationship Blood level Cmin≥150 µg/mL: 2X median and 3X one-year survival Ongoing Phase 2 locally advanced inopera
Slide 10: IPF Phase 2b Placebo-Controlled Study (067) Promising Results
IPF Phase 2b Placebo-Controlled Study (067) Promising Results Study Design Double-blind, placebo-controlled 103 patients randomized (1:1) to receive pamrevlumab or placebo for 48 weeks Phase 2 Positive Results ─ Phase 3 Enabling Magnitudes of treatment effects larger than published results on approv
Slide 11: PRAISE IPF Phase 2b Met Primary Endpoint
PRAISE 049 Study Placebo PRAISE (067) IPF Phase 2b Met Primary Endpoint; Significantly Less Decline in FVC% Predicted Change From BL at Week 48 Pamrevlumab Pamrevlumab *Both studies analyzed using the Linear Slope method Treatment effect with pamrevlumab consistent with results from prior 049 Phase
Slide 12: Pamrevlumab Attenuated FVC Decline
PRAISE (067) IPF Phase 2b Pamrevlumab Attenuated FVC Decline Pamrevlumab significantly attenuated FVC decline from Baseline to Week 48. p = 0.0249 In separate studies, pamrevlumab has larger treatment difference from placebo than nintedanib and pirfenidone in preservation of FVC. Pamrevlumab Ph 2 PR
Slide 13: Pamrevlumab Reduces Proportion with FVC Decline ≥10% or Death
Visit (Weeks) P-Value* 0.1235 0.0527 0.0172 0.0103 Pamrevlumab, n (%) 3 (6.0%) 3 (6.0%) 5 (10.0%) 5 (10.0%) Placebo, n (%) 7 (13.7%) 9 (17.6%) 15 (29.4%) 16 (31.4%) Difference (%) -11.6% - 21.4% Relative Difference -56% -66% -66% -68% PRAISE (067) IPF Phase 2b Pamrevlumab Reduces The Proportion of S
Slide 14: Pamrevlumab Attenuates Fibrosis Progression (HRCT)
PRAISE (067) IPF Phase 2b Pamrevlumab Attenuates Fibrosis Progression (HRCT) Preliminary ITT and subgroup analyses of HRCT data show evidence for pamrevlumab to attenuate lung fibrosis. Full analysis coming soon. Pamrevlumab subgroup analysis of relative change in HRCT compared to nintedanib Phase 3
Slide 15: Pamrevlumab Improves HRQoL (Lowers SGRQ Score)
PRAISE (067) IPF Phase 2b Pamrevlumab Improves HRQoL (Lowers SGRQ Score) St. Georges Respiratory Questionnaire (SGRQ) Respiratory-specific questionnaire developed to assess HRQoL in patients with lung disease (originally in obstructive lung disease), used in a number of IPF trials, including ninteda
Slide 16: Pamrevlumab Safety Profile
PRAISE (067) IPF Phase 2b Pamrevlumab Safety Profile Pamrevlumab was well-tolerated, no safety signals; favorable relative to placebo in key safety variables in PRAISE study 067 Deaths: 3 (pamrevlumab) vs. 6 (placebo) TESAE (treatment-emergent serious adverse events) leading to discontinuation: 3 (p
Slide 17: Market Opportunity for New IPF Therapy
Market Opportunity for New IPF Therapy Orphan disease U.S. prevalence ~44,000 to 135,0001 U.S. incidence ~21,000 to 52,0001 cases per year Progressive disease can result in irreversible loss of lung function with high morbidity and mortality rates Median survival of 3-5 years following diagnosis Cur
Slide 18: Relationship of One-Year Survival to Dose
Relationship of One-Year Survival to Dose Percent One-Year Survival Rate Dose-related increase in survival Day 15 minimum pamrevlumab plasma level ≥150 µg/mL 2x median survival (9.4 vs. 4.8 months) (p=0.025) 3x one-year survival (37% vs.11%) (p=0.01) Completed Ph 2 for Treatment of Advanced Pancreat
Slide 19: Pamrevlumab: A New Approach to Non-Surgical Pancreatic Cancer
Pamrevlumab: A New Approach to Non-Surgical Pancreatic Cancer May improve resection rate of locally advanced pancreatic tumors, potential for substantial survival benefit Median survival in pancreatic cancer patients with locally advanced non-resected tumors is 8-12 months Median survival in pancrea
Slide 20: Opportunities in Pancreatic Cancer
Opportunities in Pancreatic Cancer Locally advanced pancreatic cancer (LAPC) population 53,000 new cases per year in U.S.1 ~26,500 (50%) patients present with no detectable metastases ~8,000 (15-20%) classified as resectable ~18,500 (30-35%) with pancreatic cancer that precludes resection Differenti
Slide 21: Roxadustat
FIBROGEN Roxadustat
Slide 22: Roxadustat Transiently Stabilizes HIF-α
LOW OXYGEN (e.g., High Altitude) HIFα ROXADUSTAT HIFβ HIFα HIF-PH1 Enzymes HIF-PH Enzymes NORMAL OXYGEN ✕ Degradation HIFα Roxadustat Transiently Stabilizes HIF-α Gene Transcription HIF-α Degrades Rapidly EPO Within or Near Physiological Range RBC Production Hepcidin Levels Iron Transport to Bone Ma
Slide 23: Roxadustat: Innovation In Anemia Therapy
Roxadustat: Innovation In Anemia Therapy Leading HIF-PHI candidate in development for anemia More than just a potential oral alternative to injectable ESAs for anemia therapy in CKD patients - clinical data indicates: Overcomes suppressive effects of inflammation on erythropoiesis, including in ESA-
Slide 24: Global Anemia Partnerships
LAUNCH FUNDING DEVELOPMENT FUNDING Global Anemia Partnerships $ Millions Japan, EU, etc. U.S., China, ROW Payments Received to Date Equity Investment in FibroGen $81 $20 $101 Upfront, Non-Contingent $360 $402 $762 Development and Reg. Milestones $543 $571 $143 Commercial Milestones $15 $653 $0 POTEN
Slide 25: Roxadustat for CKD Anemia: Robust Phase 3 Results
Roxadustat for CKD Anemia Robust Phase 2 Results Aspects of roxadustat as potential anemia therapy Correction in presence of inflammation No IV iron required Potential to avoid high-dose ESA risk Favorable safety vs. ESAs No hypertensive effect No thrombocytosis Additional favorable effects Reduced
Slide 26: Large Global Phase 3 Program in Anemia
Large Global Phase 3 Program in Anemia Four Regulatory Pathways In Parallel U.S./EU Global Phase 3 with target program completion in 2018, to prepare for NDA & MAA submissions, subject to accrual of sufficient MACE events Astellas Japan Phase 3 (4 DD-CKD; 2 NDD-CKD) First Phase 3 DD-CKD study comple
Slide 27: Roxadustat for CKD Anemia in China: NDA In Review
Roxadustat for CKD Anemia in China NDA In Review Primary endpoint met in both Phase 3 trials NDA submission as Class 1 domestic applicant Rolling submission, completed 10/2017 Expedited Review Status Primary Efficacy Safety Subjects Arm Endpoint Assessment 200 Roxadustat 26 weeks 100 ESA 52 weeks 10
Slide 28: Roxadustat Efficacy Not Affected by Inflammation
Study 806 China Phase 3 CKD-Dialysis Roxadustat Efficacy & Potency Not Affected by Inflammation in Contrast to EPO Roxadustat Inflammation (High CRP) No impact on Hb or dose requirement EPO Inflammation (High CRP) Lower Hb despite higher doses
Slide 29: Roxadustat Phase 3 Program Updates
Roxadustat Phase 3 program Updates US/EU Program: Ongoing periodic safety review by DSMB Most recent meeting in 4Q, 2017: continue studies without protocol change First Japan Phase 3 Study completed (CL-302): peritoneal dialysis 92.3% of ESA-naïve patients and 74.4% of ESA-conversion patients mainta
Slide 30: CKD Anemia Market Opportunity: U.S. and China
U.S. China CKD Anemia Market Opportunity Prevalence >35 million patients 475,000 patients on dialysis 17 million stage 3-5 patients not on dialysis Diabetes and hypertension are primary causes of CKD Broader CKD anemia population opportunities where hepcidin modulation may be beneficial AZ has stron
Slide 31: Financial Highlights
FIBROGEN Financial Highlights
Slide 32: Financial Highlights
Financial Highlights Cash balance of $762.7M as of September 30, 2017 Earned $15M milestone from AstraZeneca for roxadustat filing in China during October, 2017 Closed an equity financing that raised net proceeds of $115.1M on April 11, 2017 Closed an equity financing that raised net proceeds of $35
Slide 33: 2018 Milestones
FIBROGEN 2018 Milestones
Slide 34: Upcoming Milestones In 2018
Upcoming Milestones In 2018 Roxadustat CKD Anemia U.S./ROW Multiple global Phase 3 studies are expected to complete in 2018 to support U.S. NDA & EU MAA submissions Expect data disclosure from these phase 3 studies Roxadustat CKD Anemia Japan A number of phase 3 studies to complete in 1H Japan dialy
Slide 35: Upcoming Milestones In 2018 (cont.)
Upcoming Milestones In 2018 (cont.) Pamrevlumab for IPF Phase 2 IPF PRAISE (067) HRCT data – 1Q 2018 IPF Phase 3 plan and EOP2 meeting Pamrevlumab for pancreatic CA Ph 2 Locally Advanced Pancreatic CA (069) study results Pancreatic CA Phase 3 plan and EOP2 meeting
Slide 36: Thank you
Thank you