Cellectar Biosciences, Inc. · NASDAQ:CLRB
Cellectar Biosciences — Investor Presentation (January 2019)
33 slides from Cellectar Biosciences's investor presentation, Jan 7, 2019
Slide 1: Corporate Presentation January 2019
Corporate Presentation January 2019 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 2 tumor targeting platform validated through clinical trials, corporate partnership
Slide 4: Projected Pipeline Key Development Milestones
PDC Program 2018 2019 2020 2021 2H 1H 2H 1H 2H 1H CLR 131 Multiple Myeloma CLR 131 B - cell Lymphoma CLR 131 Head & Neck 8 CLR 131 Pediatric 9 CLR 1900 Phase 1b Fractionated Dose Readout Phase 3 Phase 2 (DLBCL) 4 Initiate Phase 1 Initiate Phase 1 Select Candidate Initiate IND Enabling Studies Phase
Slide 5: 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 6: CLR 131 Overview
CLR 131 Overview 1 6 Phase 2 R/R B - cell Lymphoma Study 2 R/R Multiple Myeloma Phase 1 Study 3 Pediatric Phase 1 Study 4
Slide 7: Radiotherapeutic Market
Radiotherapeutic Market • Radiotherapeutic market forecast ~$9.3 billion revenue in 2020 1 • Bayer’s Xofigo® revenue ~$500M in 2017 2 • Y - mABs Therapeutics market cap of ~$625M 3 – Direct injection of ADC 4 (iodine 131 payload) into CNS 5 for brain metastases • Progenics Pharma market cap of ~$350
Slide 8: Strategic Positioning
• CLR 131 is a Targeted Radiotherapeutic – Cytotoxic radioisotope - iodine 131 – Delivery platform provides novel mechanism of action • Establish Phase 2 data for DLBCL & MM to drive potential partnerships – Potential for cost - effective & accelerated regulatory pathway for R/R 1 MM • Advance R/R n
Slide 9: Hematology Clinical Trials
Hematology Clinical Trials • R/R Hematologic Phase 2 Study – DLBCL Interim Data • 33% Overall Response Rate (ORR) - 50% Clinical Benefit Rate (CBR) • Achieved pre - determined efficacy hurdle to expand cohort – Waldenstrom’s (LPL) Case Study • Patient presenting with multiple large tumor nodules – M
Slide 10: Pediatric Clinical Trial
Pediatric Clinical Trial • FDA approved Phase 1 protocol – Planned multicenter study ( U.S. and International Sites) – Phase 1 ready to initiate 1 • Orphan drug designations (ODD) and rare pediatric designations (RPDD) – Neuroblastoma, Osteosarcoma, Rhabdomyosarcoma & Ewing's Sarcoma – All indicatio
Slide 11: CLR 131 Overview
CLR 131 Overview 1 11 Phase 2 R/R B - cell Lymphoma Study 2 R/R Multiple Myeloma Phase 1 Study 3 Pediatric Phase 1 Study 4
Slide 12: R/R B-cell Lymphoma Market Overview
R/R B - cell Lymphoma Market Overview CLR 131 Targeting 75% of the Patients (Stage 3, 4 and Unstaged) 25% 14% 16% 34% 11% Percent Patients by Stage Stage 1 Stage 2 Stage 3 Stage 4 Unknown Only in originating layer of cells Confined to primary site Spread to regional lymph nodes Metastatic disease Un
Slide 13: R/R B-cell Lymphoma Market Opportunity
R/R B - cell Lymphoma Market Opportunity New Drugs Needed in Select B - cell Lymphomas 0 10 20 30 40 50 60 70 80 90 DLBCL CLL MCL Mortality First Second Third 0 10 20 30 40 50 60 70 80 90 100 DLBCL CLL MCL Response Rates First Second Third High Mortality and Poor Response Rates Remain in Second and
Slide 14: Ongoing R/R Hematologic Phase 2 Study
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 15: Phase 2 DLBCL Interim Data
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 1Q18 • 33% Overall Response Rate (ORR) - 50% Clinical Benefit Rate (CBR) • Of responses observed, overall tumor red
Slide 16: Phase 2 LPL Patient Case Study (Waldenstrom's)
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 ovary CT
Slide 17: Proposed B-cell Lymphoma Pivotal Study
n = 15 - 20 n = 60 - 80 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 18: CLR 131 Overview
CLR 131 Overview 1 18 Phase 2 R/R B - cell Lymphoma Study 2 R/R Multiple Myeloma Phase 1 Study 3 Pediatric Phase 1 Study 4
Slide 19: R/R Multiple Myeloma Market Opportunity
New Treatments are Needed R/R Multiple Myeloma Market Opportunity Approximately 40% of TRx Eligible P atients in Third L ine or Greater Elect N ot to R eceive F urther TRx 19 1. DRG 2018 0 10 20 30 40 50 60 70 First Second Third Fourth Fifth Overall Response Rate (%) Line of Therapy Post - Relapse R
Slide 20: R/R Multiple Myeloma Market Opportunity: mOS
New Treatments are Needed R/R Multiple Myeloma Market Opportunity CLR 131 Achieved mOS of 22 Months in Single D ose C ohorts 0 2 4 6 8 10 12 14 16 18 20 All Drugs Carfilzomib Daratumumab Pomal. (+dex) Months 4.9 Months Average Median Overall Survival (mOS) in Third Line 11.9 Months 11.9 Months 18.6
Slide 21: R/R 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 (Total dose 31.25) 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 P
Slide 22: R/R MM Tolerability and Key Results
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 adverse events – All viewed as predictable & manageable • ≥
Slide 23: CLR 131 Overview
CLR 131 Overview 1 23 Phase 2 R/R B - cell Lymphoma Study 2 R/R Multiple Myeloma Phase 1 Study 3 Pediatric Phase 1 Study 4
Slide 24: Preclinical Results
• 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 24 Eff
Slide 25: 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 2 Program Timin g 3 Clinical Costs 3 • Granted ODD & RPDD for NB, RMS, and Ewing’s Sarcoma • Eligible for Fast Track, Breakthrough and SPA submissions • Initial e
Slide 26: CLR & 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 27: CLR 1900 Our Preclinical Pipeline
CLR 1900 1 27 Our Preclinical Pipeline
Slide 28: CLR 1900 Mechanism of Action
• 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 29: Corporate Information
Corporate Information Vv ©, CELLECTAR BIOSCIENCES
Slide 30: Financial Summary
Financial Summary Capitalization as of November 9, 2018 Common Stock Outstanding 4,757,786 Reserved for issuance: Convertible Preferred Stock 1,182,500 Warrants 5,318,747 Employee Options 256,304 Fully Diluted 11,515,337 Cash / Equivalents as of September 30, 2018 ~$16.4 million Cash Believed to Be
Slide 31: Executive Leadership
Jim Caruso President, CEO and Director HIP Innovation Technology - EVP & COO, Allos Therapeutics - EVP & CCO, BCI, Novartis, BASF, Bristol - Myers Squibb Jarrod Longcor Chief Business Officer Avillion LLP - CBO Melinta Therapeutics, Inc. (formerly Rib - X Pharmaceuticals, Inc). - VP Corp Development
Slide 32: Company Highlights
Developing orphan and rare pediatric oncology pipeline with multibillion - dollar 1 sales potential 32 Efficient capital allocation and low fixed - cost corporate structure allows for ~$10M - $12M annual cash burn PDC 2 tumor targeting platform validated through clinical trials, corporate partnershi
Slide 33: Thank You
Thank You Vv ©, CELLECTAR BIOSCIENCES NASDAQ: CLRB
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