Cellectar Biosciences, Inc. · NASDAQ:CLRB
Cellectar Biosciences — Investor Presentation (October 2018)
29 slides from Cellectar Biosciences's investor presentation, Oct 2, 2018
Slide 1: Corporate Presentation October 2018
Corporate Presentation October 2018 NASDAQ: CLRB
Slide 2: Forward-Looking Statements
Forward - Looking Statements This presentation contains forward - looking statements . Such statements are valid only as of today and we disclaim any obligation to update this information . These statements are only estimates and predictions and are subject to known and unknown risks and uncertainti
Slide 3: Company Highlights
Developing orphan and rare pediatric oncology pipeline with multibillion - dollar 1 sales potential 3 Efficient capital allocation and low fixed - cost corporate structure allows for ~$10M - $12M annual cash burn PDC tumor targeting platform validated through clinical trials and corporate partnershi
Slide 4: Cellectar Accomplishments and Robust Pipeline Focused on Unmet Need in Cancer
Cellectar Accomplishments in the Past 3 Years Robust Pipeline Focused on Unmet Need in Cancer 1 Mid - stage Clinical Compound 9 FDA Special Designated Programs 5 ODD 1 4 RPDD 2 9.8 Million Dollars in non - dilutive funding 6 Preclinical Phospholipid Drug Conjugate (PDC) Programs Creating the Next Ge
Slide 5: Pipeline Focus on Niche Oncology Indications
Pipeline Focus on Niche Oncology Indications with Accelerated Commercial Timelines to Scalable Markets PDC 1 Indications Discovery Pre - IND Phase 1 Phase 2 Payload CLR 131 Multiple Myeloma 2 Iodine - 131 B - Cell Lymphomas 2 Pediatric Cancer Head & Neck 3 CLR 1700 Hematologic Tumors BTK 4 CLR 1900
Slide 6: Projected Key Development Milestones
Program 2018 2019 2020 2021 1H 2H 1H 2H 1H 2H 1H CLR 131 Multiple Myeloma CLR 131 B - cell Lymphoma CLR 131 Head & Neck CLR 131 Pediatric CLR 1700 CLR 1900 Phase 1b Fractionated Dose Readout Initiate Phase 2 ( DLBCL 6 ) Phase 3 MZL 7 Phase 2 (DLBCL) 3 Initiate Phase 1 Initiate Phase 1 Initiate Phase
Slide 7: PDC Platform Technology
• Entry via lipid rafts and transmembrane flipping • Delivery directly to cytosol • PDCs will accumulate along the Golgi apparatus network and endoplasmic reticulum Precision Targeting Optimized Entry Unique Linker Chemistry & Diversity of Payloads Extracellular Space Intracellular (Cytoplasm) PDC L
Slide 8: Our Pipeline
Our Pipeline CLR 1700 CLR 131 CLR 1900 2 1 3 8
Slide 9: CLR 131: Manufacturing Update
9 CLR 131: Manufacturing Update • CLRB notified of FDA CPDC 1 Import Action on 8/07/18 which prevented shipment of CLR 131 into the U.S. • The Import Alert stemmed from audit observations for a different product manufactured at a different building on the CPDC campus • CPDC and the FDA completed a m
Slide 10: CLR 131 Strategic Approach and Market Opportunity
• Radiotherapeutic market forecast ~$9.3 billion revenue in 2020 1 – Novartis acquires Advanced Accelerator Applications for $3.9 billion 2 • Lead product Lutathera - radioligand t herapy – Bayer’s Xofigo® radiotherapeutic generates $473M in revenue 3 – Progenics Pharma Azedra™ (MIBG I - 131) market
Slide 11: CLR 131: RR Hematologic Phase 2 Study Overview
Patients screened N=10 DLBCL N=10 MCL N=10 CLL/SLL, MZL, LPL Follow - up (≥ 1 yr after last dose) Final efficacy assessments Interim efficacy assessments; expand cohorts based on performance 10 - 30 CLL/SLL, MZL, LPL 10 - 30 MCL 10 - 30 DLBCL • Primary endpoint is efficacy as determined by response
Slide 12: CLR 131: Phase 2 DLBCL Interim Data
CLR 131: Phase 2 DLBCL Interim Data • Diffuse Large B - cell Lymphoma (DLBCL) is an aggressive form of lymphoma, accounting for ~30% of newly diagnosed cases in the U.S. 1 • DLBCL cohort opened 1Q - 18 • 33% Overall Response Rate (ORR) to date • 50% Clinical Benefit Rate (CBR) to date • Of responses
Slide 13: CLR 131: Phase 2 LPL Patient Case Study (Waldenstrom's)
CLR 131: Phase 2 LPL Patient Case Study (Waldenstrom’s) 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000 Screen (11/2017) Day 52 (12/2017) Day 120 (3/2018) Day 186/64 (5/2018) Tumor size (mm2) Days from CLR 131 infusion Sub diaphramatic mass Left epicardial mass Aortic bifurcation Right ovary Left
Slide 14: CLR 131: B-cell Lymphoma Clinical Development Strategy
n = 20 - 30 n = 50 - 60 Proposed Phase 2/3 Adaptive Design Pivotal Study (for LPL, MZL or MCL) Proposed Phase 2/3 Pivotal Study Design Program Timing 1 Clinical Costs 1 • Relapsed/refractory niche lymphoma indication • Phase 2b enrollment of ~20 patients • Phase 3 pivotal, single - arm – Primary end
Slide 15: CLR 131: Relapsed/Refractory Multiple Myeloma
→ Most approved drugs for R/R MM in third line or later average 11.9 months of survival, including several recent additions → Darzalex™ for third - line treatment averages 18.6 months of survival → Most treatments are now given in combination for use in earlier lines of therapy; most frequent is tri
Slide 16: CLR 131: RR MM Phase 1 Study Overview
Cohort 1 12.5 mCi/m 2 Cohort 2 18.75 mCi/m 2 Cohort 3 25.0 mCi/m 2 Cohort 4 31.25 mCi/m 2 Cohort 5 15.625 mCi/m 2 x 2 Metric Cohort 1 (12.5 mCi/m 2 ) Cohort 2 (18.75 mCi/m 2 ) Cohort 3 (25.0 mCi/m 2 ) Cohort 4 (31.25 mCi/m 2 ) Cohort 5 (31.25 mCi/m 2 ) Average Age 68 70 71 65 71 Prior # of Treatment
Slide 17: CLR 131: RR MM Phase 1 Key Results
TIME (MONTHS) 19.4 M onths SURVIVAL ONGOING 0 5 10 15 Key Results To Date 1 • All cohorts determined to be safe and well - tolerated by independent DMC • No patients experiencing peripheral neuropathy, deep vein thrombosis, cardiotoxicities, embolisms or GI toxicities • Cytopenias most common advers
Slide 18: CLR 131: Efficacy in Pediatric Preclinical Models
• Various mouse models demonstrate significant uptake of CLR 131 – Neuroblastoma, Rhabdomyosarcoma, Ewing's Sarcoma, Osteosarcoma • Uptake correlated to reduction in tumor volume and ~50% slowing of tumor growth • Minimal adverse effects were seen on hematologic parameters Preclinical Results 18 CLR
Slide 19: Pediatric Proposed Phase 2/3 Pivotal Study Design
Level 1 15 mCi/m 2 Level 2 30 mCi/m 2 Level 3 45 mCi/m 2 Add’l levels +15 mCi/m 2 n=1 n=3 n=3 n=3 Proposed Phase 2/3 Pivotal Study Design 1 Program Timin g 2 Clinical Costs 2 • Granted ODD & RPDD for NB, RMS, and Ewing’s Sarcoma • Eligible for Fast Track, Breakthrough and SPA submissions • Initial e
Slide 20: CLR 131 & MIBG Product Profile Comparison
CLR 131 & MIBG Product Profile Comparison Profile CLR 131 MIBG I - 131 Delivery Vehicle/Payload Phospholipid Ether (PLE)/ Iodine - 131 Meta - iodobenzylguanidine/ Iodine - 131 Therapeutic Regimen Single 30 minute mCi infusion Total dose ~45 - 80 mCi 3 - 5 cycles, ~300 mCi per cycle, 90 - 120 minute
Slide 21: Our Preclinical Pipeline
CLR 131 1 21 Our Preclinical Pipeline CLR 1700 CLR 1900 2 3
Slide 22: CLR 1700: Proprietary Chemotherapeutic PDC Program
• CLR 1700 payload inhibits Burton’s Tyrosine Kinase (BTK) • BTK inhibitors work only in hematologic cancers • Induces tumor cell apoptosis • Currently approved BTK inhibitors generate annual revenue of ~$4 billion 1 • Program is currently in lead optimization 5.00E+08 5.05E+10 1.01E+11 1.51E+11 2.0
Slide 23: CLR 1900: Chemotherapeutic PDC Program
• CLR 1900 payload inhibits mitosis (cell division) • Targets a key element in the pathway required for mitosis • Payload represents a novel class of molecules and a novel target • Pathway inhibition has been validated with other classes of molecules; results in apoptosis of tumor cells • Select sol
Slide 24: Corporate Information
Corporate Information Vv @ 7 CELLECTAR BIOSCIENCES
Slide 25: Financial Summary
Financial Summary Capitalization as of September 4, 2018 Common Stock Outstanding 3,797,825 Reserved for issuance: Convertible Preferred Stock 2,142,500 Warrants 5,318,747 Employee Options 56,919 Fully Diluted 11,315,991 Cash / Equivalents as of June 30, 2018 ~$4.2 million Pro Forma Cash / Equivalen
Slide 26: Projected Key Development Milestones
Program 2018 2019 2020 2021 1H 2H 1H 2H 1H 2H 1H CLR 131 Multiple Myeloma CLR 131 B - cell Lymphoma CLR 131 Head & Neck CLR 131 Pediatric CLR 1700 CLR 1900 Phase 1b Fractionated Dose Readout Initiate Phase 2 ( DLBCL 6 ) Phase 3 MZL 7 Phase 2 (DLBCL) 3 Initiate Phase 1 Initiate Phase 1 Initiate Phase
Slide 27: Executive Leadership
Jim Caruso President, CEO and Director HIP Innovation Technology - EVP & COO, Allos Therapeutics - EVP & CCO, BCI, Novartis, BASF, Bristol - Myers Squibb John Friend, MD Chief Medical Officer Helsinn Therapeutics - SVP & Head of R&D, Akros Pharma, Actavis, Alpharma, Hospira, Abbott Jarrod Longcor Ch
Slide 28: Company Highlights and Market Sources
1. ResearchAndMarkets.com's offering. Neuroblastoma - Market Insights, Epidemiology and Market Forecast - 2027 The market of Neuro blastoma in 7MM was found to be USD 733.58 million in 2016, and is expected to increase at from 2016 - 2027. Market Research Future Jan 2018 The osteosarcoma market has
Slide 29: Thank You
Thank You YZ @ 7 CELLECTAR BIOSCIENCES NASDAQ; CLRB
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