Cellectar Biosciences, Inc. · NASDAQ:CLRB
Cellectar Biosciences — Investor Presentation (September 2018)
21 slides from Cellectar Biosciences's investor presentation, Sep 6, 2018
Slide 1: Corporate Presentation September 2018
Corporate Presentation September 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 in the Past Years
Cellectar Accomplishments in the Past 3 Years Robust Pipeline Focused on Unmet Need in Cancer 1 Mid - stage Clinical Compound 6 FDA Special Designated Programs 4 ODD 1 3 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: CLR 131
CLR 131 CLR 131 1 6
Slide 7: CLR 131: Manufacturing Update
7 CLR 131: Manufacturing Update • CLRB notified of FDA CPDC 1 Import Action on 8/07/18 • Import Action derived from an FDA inspection of CPDC on 3/28/18 • CLRB was not previously notified since the inspection observations were not related to CLR 131 • The product flagged is manufactured in a differe
Slide 8: CLR 131 Strategic Approach and Radiotherapeutic Market
• Radiotherapeutic Market forecast ~$9.3 billion revenue in 2020 1 – Novartis acquires Advanced Accelerator Applications for $3.9 billion 2 • Lead product Lutathera - Radioligand Therapy – Bayer’s Xofigo® radiotherapeutic generates $473M in revenue 3 – Progenics Pharma Azedra™ (MIBG I - 131) market
Slide 9: CLR 131: 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 Phase 1b Fractionated Dose Readout Initiate Phase 2 (DLBCL) Phase 3 MZL Phase 2 (DLBCL) 2 Initiate Phase 1 Initiate Phase 1 Initiate Phase 2 Phase 3 Interim Asses
Slide 10: 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 11: CLR 131: Phase 1 Overall Survival and Key Results
TIME (MONTHS) 15.0 months SURVIVAL ONGOING 0 5 10 15 Key Results To Date 1 • All cohorts determined to be safe and well - tolerated by independent DMC 3 • No patients experiencing peripheral neuropathy, deep vein thrombosis, cardiotoxicities, embolisms or GI toxicities • Cytopenias most common adver
Slide 12: 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 13: 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 14: 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 15: 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 16: CLR 131 & MIBG Product Profile Comparison
CLR 131 & MIBG Product Profile Comparison Profile CLR 131 MIBG - I131 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 17: Corporate Information
Corporate Information YZ @ 7, CELLECTAR BIOSCIENCES
Slide 18: 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 19: 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 20: Company Highlights
Developing orphan and rare pediatric oncology pipeline with multibillion - dollar 1 sales potential 20 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 partnersh
Slide 21: Thank You
Thank You YZ @ 7, CELLECTAR BIOSCIENCES NASDAQ; CLRB
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