Kyntra Bio, Inc. · NASDAQ:KYNB
Kyntra Bio — Fibrogen — Investor Presentation (January 2019)
33 slides from Kyntra Bio's investor presentation, Jan 7, 2019
Slide 1: FibroGen, Inc. Corporate Presentation January 2019
FibroGen, Inc. Corporate Presentation January 2019 Exhibit 99.1
Slide 2: Forward-Looking Statements
This presentation contains “forward-looking” statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition, business strategy, and plans, and objectiv
Slide 3: 2019: A Transformational Year
2019: A Transformational Year >5 Anemia associated with CKD Approved in China for dialysis in 2018 NDA approval decisions expected in 2019: Japan for dialysis China for non-dialysis NDA submissions expected in 2019: U.S., EU, other territories Anemia Associated with MDS One U.S./EU Phase 3, one Chin
Slide 4: Product Portfolio
Product Portfolio HIF-PHI PRECLINICAL PHASE 1 PHASE 2 PHASE 3 APPROVED Roxadustat CKD Anemia United States, Europe China1 Japan2 Roxadustat MDS Anemia United States, Europe China (Phase 2/3) ANTI-CTGF PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Pamrevlumab Idiopathic Pulmonary Fibrosis Pancreatic Cancer Duc
Slide 5: Corporate and Financial
Corporate and Financial 465 employees worldwide 310 U.S. 155 ex-U.S. San Francisco headquarters with subsidiary in Beijing Appointed Maykin Ho, Ph.D., to Board of Directors in December 2018 Well-managed financial position No debt Year-end cash balance projection of $720M to $730M $722M cash as of Se
Slide 6: Roxadustat Anemia
Roxadustat Anemia
Slide 7: Roxadustat: An Innovative Approach to Addressing Anemia
Roxadustat: An Innovative Approach to Addressing Anemia *First approved in China for anemia associated with CKD in dialysis-dependent patients on December 17, 2018. ROXADUSTAT HAS BEEN SHOWN TO BE MORE THAN AN ORAL ALTERNATIVE TO ESAs Overcomes suppressive effects of inflammation on erythropoiesis C
Slide 8: Roxadustat: The Leader in Oral HIF-PHI Anemia Therapeutics
Roxadustat: The Leader in Oral HIF-PHI Anemia Therapeutics Anemia in CKD Patients U.S./EU Positive Phase 3 results from five trials announced by FibroGen and AstraZeneca December 2018 Positive Phase 3 topline results announced by Astellas from first EU study All Phase 3 studies supporting U.S. NDA a
Slide 9: Roxadustat in China
Roxadustat in China FIRST APPROVAL China is the first country to approve a HIF-PHI FIRST TO MARKET Commercialization Activities FibroGen and AstraZeneca China working closely to prepare for 2H 2019 launch FibroGen China to lead: Medical Affairs Pharmacovigilance Regulatory Affairs Commercial Manufac
Slide 10: U.S. and China CKD Anemia Market Opportunity
U.S. and China CKD Anemia Market Opportunity ADDRESSING UNDERSERVED, GROWING, AND EMERGENT PATIENT POPULATIONS 1United States Renal Data System (USRDS) estimate as of 2016 UNITED STATES CHINA >35M CKD patients Linked to diabetes and hypertension Hepcidin modulation may benefit broader CKD anemia pop
Slide 11: Global Registration Programs: Enrollment Summary
CL-314 ESA naive, non-dialysis, open label 100 CL-310 ESA conversion, non-dialysis, vs. darbepoetin ~325 Japan Non-Dialysis Total N ~425 Global Registration Programs: Enrollment Summary GLOBAL PHASE 3 STUDIES FOR U.S. NDA, EU MAA DD-CKD Studies N Population, Comparator HIMALAYAS (FibroGen) 063 1,043
Slide 12: ANDES Roxadustat Phase 3 CKD-NDD Study
ANDES Roxadustat Phase 3 CKD-NDD Study(060) Randomized, double-blind, placebo-controlled study in U.S., APAC, S. America Chronic kidney disease (Stages 3, 4, or 5) not on dialysis, no prior ESA use N=922; roxadustat (n=616) vs. placebo (n=306) Treatment Duration: up to 4.5 years, mean=1.7 years U.S.
Slide 13: HIMALAYAS Roxadustat Phase 3 Incident Dialysis Study
HIMALAYAS Roxadustat Phase 3 Incident Dialysis Study (063) Randomized, open-label, active-controlled global study (U.S., Asia Pacific, Europe, Russia, S. America) Anemic incident dialysis patients with baseline Hb <10 g/dL, minimal to no prior ESA use N=1043; roxadustat (n=522) vs. epoetin alfa (n=5
Slide 14: SIERRAS Roxadustat Phase 3 Conversion Study in Dialysis Patients
SIERRAS Roxadustat Phase 3 Conversion Study in Dialysis Patients (064) Randomized, open-label, active-controlled U.S. study N=741; roxadustat (n=370) vs. epoetin alfa (n=371) Stable dialysis patients with baseline Hb 9 - 12 g/dL, on stable doses of ESA Newly initiated dialysis patients with baseline
Slide 15: Roxadustat Phase 3 Clinical Studies Topline Result (AstraZeneca Sponsored)
Olympus Phase 3 CKD-NDD Study Double-blind, placebo-controlled study in 26 countries CKD patients, non-dialysis (Stages 3, 4 or 5) with baseline Hb <10 g/dL N=2,781; randomized 1:1, roxadustat or placebo Primary Efficacy Endpoint The trial met its primary efficacy endpoint by demonstrating a statist
Slide 16: Roxadustat Ongoing Pivotal MDS Anemia Studies
U.S. / EU Phase 3 MDS Study Patient population: transfusion-dependent, ESA-naïve, lower risk MDS patients Open-label lead-in: N up to 24 Starting doses (8 each): 1.5 mg/kg, 2.0 mg/kg, 2.5 mg/kg Double-blind, placebo-controlled: N=160 3:2 randomization, roxadustat vs. placebo Primary endpoint at 28 w
Slide 17: Pamrevlumab
Pamrevlumab
Slide 18: Pamrevlumab: Three High-Value, High-Need Indications
Idiopathic Pulmonary Fibrosis (IPF) FDA Fast Track designation Phase 3 study planned to start in Q1 2019 Randomized placebo-controlled, double-blind study similar to PRAISE Phase 2b study design Primary endpoint will be change in forced vital capacity (FVC) from baseline Pancreatic Cancer (LAPC) FDA
Slide 19: Pamrevlumab: Potential Innovative Treatment for Fibrosis and Fibroproliferative Diseases
Pamrevlumab: Potential Innovative Treatment for Fibrosis and Fibroproliferative Diseases
Slide 20: Pamrevlumab Idiopathic Pulmonary Fibrosis
Pamrevlumab Idiopathic Pulmonary Fibrosis
Slide 21: IPF Patients Need New Therapeutic Options
IPF Patients Need New Therapeutic Options 1 Raghu 2006 and United Nations Population Division 2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3848422/ Slow pulmonary function loss Modest effect on slowing disease progression No demonstration of reversal Require side effect management ~$1.8B 2017 sale
Slide 22: Pamrevlumab IPF Phase 3 Study Design
Patient Population IPF patients who are not being treated with approved therapies IPF diagnosis according to ATS/ERS/JRS/ALAT guidelines* Study Design Placebo-controlled, double-blind Similar to PRAISE Phase 2b study Enroll ~500 patients Randomization 3:2 pamrevlumab or placebo Primary Endpoint Chan
Slide 23: Pamrevlumab IPF Program: Positive Phase 2 Results
PRAISE Phase 2 double-blind, placebo-controlled study (n=103) Met primary endpoint of change in FVC % predicted from baseline to Week 48 Average decline in FVC by Week 48 was significantly less in pamrevlumab arm Significantly smaller proportion of patients in the pamrevlumab arm experienced disease
Slide 24: Pamrevlumab Pancreatic Cancer
Pamrevlumab Pancreatic Cancer
Slide 25: LAPC Patient Population Lacks Treatment Options
LAPC Patient Population Lacks Treatment Options 1 2018 Estimates: http://seer.cancer.gov/statfacts/html/pancreas.html ADDRESSING UNDERSERVED, GROWING, AND EMERGENT PATIENT POPULATIONS new U.S. patients Dx annually1 Clinical significance of resection 55K ~27,700 (50%) present with no detectable metas
Slide 26: LAPC Pivotal Phase 3 Study Design
Patient Population Locally advanced, unresectable pancreatic cancer ECOG 0-1 No prior therapy Study Design Double-blind, placebo-controlled Enroll ~260 subjects at 40-60 sites globally Randomization 1:1 pamrevlumab + gemcitabine/nab-paclitaxel or placebo + gemcitabine/nab-paclitaxel 6 cycles of neoa
Slide 27: Pancreatic Cancer Program: Positive Clinical Results from Phase 1/2 Studies
Pancreatic Cancer Program: Positive Clinical Results Reported from Phase 1/2 Studies STUDY 069 IN LOCALLY ADVANCED UNRESECTABLE PANCREATIC CANCER* Resection results: Higher proportion of patients in pamrevlumab arm: Eligible for surgical exploration 70.8% vs.15.4% (pamrevlumab vs. control, respectiv
Slide 28: Pamrevlumab Duchenne Muscular Dystrophy
Pamrevlumab Duchenne Muscular Dystrophy
Slide 29: DMD Background
Affects ~1 in every 5,000 newborn boys About 20,000 children are diagnosed with DMD globally each year The fatal disease is caused by genetic mutations leading to the absence or defect of dystrophin, a protein necessary for normal muscle function. The absence of dystrophin results in muscle weakness
Slide 30: Pamrevlumab DMD Program
Design Open-label, single-arm study in 21 non-ambulatory boys, 12 years of age and older Objective Efficacy, safety and tolerability, and PK Endpoints Change from baseline in: Pulmonary function tests Upper body muscle function tests Muscle and cardiac fibrosis by MRI imaging Study Status Fully enro
Slide 31: Upcoming Roxadustat Milestones
CKD Anemia U.S. / ROW Pooled MACE safety data analysis (dialysis, non-dialysis) anticipated in the first half of 2019 NDA submission to FDA for the treatment of anemia in dialysis-dependent and non-dialysis-dependent CKD patients anticipated in the first half of 2019 CKD Anemia China Regulatory appr
Slide 32: Upcoming Pamrevlumab Milestones
Idiopathic Pulmonary Fibrosis Plan to commence Phase 3 clinical study in the first quarter of 2019 Locally Advanced Unresectable Pancreatic Cancer Initiate Phase 3 clinical study in the first quarter of 2019 Duchenne Muscular Dystrophy Anticipate completing first year of treatment and reporting topl
Slide 33: Thank you
Thank you