Cartesian Therapeutics, Inc. · NASDAQ:RNAC
Cartesian Therapeutics — Selecta Biosciences — Q3 2017 Earnings Presentation
24 slides from Cartesian Therapeutics's earnings presentation, Nov 7, 2017
Slide 1: Third Quarter 2017 Conference Call
Third Quarter 2017 Conference Call Nasdaq: SELB November 7, 2017
Slide 2: Safe Harbor / Disclaimer
Safe Harbor / Disclaimer 2 Any statements in this presentation about the future expectations, plans and prospects of Selecta Biosciences, Inc. (“the company”), including without limitation, the progress of the Phase 1/2 clinical program of SEL-212, the potential of SEL-212 to treat severe gout patie
Slide 3: Imagine If We Could…
3 IMAGINE IF WE COULD… 1. Effectively treat many more patients with existing biologics 2. Enable a new generation of novel non-immunogenic biologics for rare and serious diseases
Slide 4: Spark Therapeutics License Agreement
Spark Therapeutics License Agreement 4 • December 2016 agreement provides Spark Therapeutics with exclusive worldwide rights to Selecta's SVP technology for up to five gene therapy targets • Initial focus on combination of SVP with Spark’s Hemophilia A gene therapy • Among the largest gene therapy a
Slide 5: SEL-212: Advancing a Potential New Treatment Option for Chronic Severe Gout Patients Toward Phase 3
SEL-212: Advancing a Potential New Treatment Option for Chronic Severe Gout Patients Toward Phase 3 5 Rare and Serious Disease • ~160,000 adults with chronic severe gout treated by U.S. rheumatologists • Debilitating flares and joint-damaging arthritis caused by uric acid deposits; risk of renal and
Slide 6: Objective: Treat Patients by Rapidly Resolving Their Uric Acid Deposits and Tophi
Objective: Treat Patients by Rapidly Resolving Their Uric Acid Deposits and Tophi 6 (1) Arujo EG et al, Tophus resolution with pegloticase: a prospective dual-energy CT study, RMD Open, 2015 Before1 After1 Uric acid deposits Calcium deposits 6.8 6.0 S e ru m U ric A cid ( m g /d L ) Time Transition
Slide 7: Advancing SEL-212 Toward Phase 3: Phase 1a
Dose (mg/kg): Advancing SEL-212 Toward Phase 3 7 Phase 1a Single Dose 0.1 0.2 0.4 0.8 1.2 = Pegsiticase; = SVP-Rapamycin
Slide 8: Advancing SEL-212 Toward Phase 3: Phase 1b
Dose (mg/kg): Advancing SEL-212 Toward Phase 3 8 Phase 1a Single Dose 0.1 0.2 0.4 0.8 1.2 Dose (mg/kg): Phase 1b Single Dose 0.4 Dose (mg/kg): 0.100.03 0.15 0.30 = Pegsiticase; = SVP-Rapamycin
Slide 9: Phase 1b Shows Greater Clinical Activity With Higher Single SVP-Rapamycin Doses
0 1 2 3 4 5 0 5 0 1 0 0 0 1 2 3 4 5 0 5 0 1 0 0 Phase 1b Shows Greater Clinical Activity With Higher Single SVP-Rapamycin Doses 9 Week 0 1 2 3 4 5 0 5 0 1 0 0 % Pt s . < 6 m g /d L % Pt s . < 6 m g /d L = Pegsiticase; = SVP-Rapamycin % Pt s . < 6 m g /d L N = 5 N = 10 N = 5 0% 70% 100% Dosing % of P
Slide 10: Phase 2 Trial Overview
Phase 2 Trial Overview 10 Enrollment Criteria Primary/Secondary Endpoints Design Dosing Stopping Rules As of October 23 • Patients with symptomatic gout and SUA levels >6 mg/dL • Safety, tolerability and pharmacokinetics of multiple doses of SEL-212 and pegsiticase alone • Reduction of SUA levels •
Slide 11: Phase 2 Trial Overview
Phase 2 Trial Overview 11 Enrollment Criteria Primary/Secondary Endpoints Design Dosing Stopping Rules As of October 23 • Patients with symptomatic gout and SUA levels >6 mg/dL • Safety, tolerability and pharmacokinetics of multiple doses of SEL-212 and pegsiticase alone • Reduction of SUA levels •
Slide 12: 2 0 0 3 6 9 1 2 0 3 6 9 1 2
0 1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 0 3 6 9 1 2 0 3 6 9 1 2 0 1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 0 3 6 9 1 2 0 3 6 9 1 2 0 1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 0 3 6 9 1 2 0 3 6 9 1 2 0 1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3
Slide 13: Cohort 5 & 6 Clinical Activity
Dosing % of Patients With SUA <6 mg/dL 0.2 mg/kg 0.08 mg/kg 0.4 mg/kg 0.08 mg/kg Cohort 5 & 6 Clinical Activity 13 Unaudited data reported as of October 23, 2017 | Clinicaltrials.gov NCT02959918 TreatTeach & Treat Week 0 1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 0 5 0 1 0 0 0 1 2
Slide 14: Cohort 7 & 8 Clinical Activity
Dosing % of Patients With SUA <6 mg/dL 0.2 mg/kg 0.10 mg/kg 0.4 mg/kg 0.10 mg/kg Cohort 7 & 8 Clinical Activity 14 Week 0 1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 0 5 0 1 0 0 0 1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 5 0 1 0 0 Unaudited data reported as of
Slide 15: Advancing SEL-212 Toward Phase 3
Dose (mg/kg): Dose (mg/kg): Dose (mg/kg): Dose (mg/kg): Advancing SEL-212 Toward Phase 3 15 Phase 1a Single Dose 0.1 0.2 0.4 0.8 1.2 Phase 1b Single Dose 0.4 0.100.03 0.15 0.30 Phase 2 3+2 Doses 0.4 0.080.05 0.10 0.125 0.2 0.15Dose (mg/kg): % Clinical Activity @ Day 30: 0% 70% 100% 100% = Pegsiticas
Slide 16: SUA Levels vs. ADA Titers
SUA Levels vs. ADA Titers 16 Unaudited data reported as of October 23, 2017 | Clinicaltrials.gov NCT02959918 101 102 103 104 105 0 2 4 6 8 10 12 Anti-Uricase IgG Titers S UA L e v e ls ( m g /d L ) SUA levels vs. ADA titers at day 21 after each dose for all patients in cohorts 1-8
Slide 17: Data Continue to Suggest Reduction in Flare Frequency During SEL-212 Therapy
1 1 2 3 4 5 0 2 0 4 0 6 0 Data Continue to Suggest Reduction in Flare Frequency During SEL-212 Therapy 17 • Data indicate SEL-212 lowers flares initially and over time during treatment • Urate lowering therapies typically increase the incidence of flares at the beginning of therapy Unaudited data as
Slide 18: SEL-212 Generally Well Tolerated at Clinically Active Doses
SEL-212 Generally Well Tolerated at Clinically Active Doses 18 • SEL-212 has been generally well tolerated at clinically active doses following >200 administrations • SAEs reported in the Phase 2 trial: - Four were reported not to be or unlikely to be related to study drug: - Two patients with a his
Slide 19: SEL-212 Generally Well Tolerated at Clinically Active Doses
SEL-212 Generally Well Tolerated at Clinically Active Doses 19 Unaudited data as of October 23, 2017 | Clinicaltrials.gov NCT02959918 Cohort Pegsiticase+SVP-Rapa Entire Study 1 0.2 2 0.4 3 0.2+0.05 4 0.4+0.05 5 0.2+0.08 6 0.4+0.08 7 0.2+0.1 8 0.2+0.1 10^ 0.4+0.125 12^ 0.4+0.15 N 79 3 3 9 10 6 11 11
Slide 20: Advancing SEL-212 Toward Phase 3
Dose (mg/kg): Dose (mg/kg): Dose (mg/kg): Dose (mg/kg): Dose (mg/kg): Advancing SEL-212 Toward Phase 3 20 Phase 1 Single Dose 0.1 0.2 0.4 0.8 1.2 Phase 1b Single Dose 0.4 0.100.03 0.15 0.30 Phase 2 3+2 Doses 0.4 0.080.05 0.10 0.125 0.2 0.15 Phase 3 • Expect to participate in End of Phase 2 meeting i
Slide 21: SEL-212 Program is Informing the Development of Other Product Candidates
SEL-212 Program is Informing the Development of Other Product Candidates 21 Chronic Therapies+ Proprietary program Potential program Single Treatment Chronic Treatment Adult Patients with Chronic Conditions Cancer Patients Pediatric Patients with Life-Threatening Conditions Oncology (SEL-403) Treatm
Slide 22: Important Additions to Selecta's Management
Important Additions to Selecta’s Management 22 John Leaman, M.D. Chief Financial Officer & Head of Corporate Strategy • 15+ years of financial, operations, corporate strategy and M&A experience at life sciences companies • Most recently served as Head of Corporate Development at InfaCare Pharmaceuti
Slide 23: 3Q17 Financial Overview
3Q17 Financial Overview 23 For the Quarter Ended (In thousands, except share and per share data) September 30, 2017 September 30, 2016 Grant & Collaboration Revenue $27 $1,048 Research & Development Expenses 9,504 6,021 General & Administrative Expenses 4,377 2,495 Net Loss Attributable to Common St
Slide 24: Thank You
Se SELECTA Biosciences Thank You