Slide 1: Cellectar Biosciences August 2015
1 Cellectar Biosciences NASDAQ: CLRB August 2015
Slide 2: Safe Harbor Statement
2 Safe Harbor Statement This slide 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 uncertain
Slide 3: Investment Overview
3 Investment Overview • Oncology - focused biopharmaceutical company in Madison, WI • First and best - in - class PDC delivery platform – Phospholipid ether - Drug Conjugate (PDC) – Cancer - targeting delivery of oncologic payloads • Pipeline of cancer therapeutics and diagnostics • New leadership d
Slide 4: PDC Product Development Pipeline
4 PDC Product Development Pipeline PDC Product Candidates Class Cancer Therapeutics Cancer Diagnostics Status Phase 1 Pre - Clinical Pre - Clinical Phase 2 Phase 1 PDC CLR 131 CLR 1601 - PTX CLR 1605 - GEM CLR 124 CLR 1502 Payload Radiotherapy Chemotherapy Chemotherapy Radioisotope PET/CT Imaging Fl
Slide 5: Basis for PDC Delivery Platform: Phospholipid Ether Cancer Targeting Vehicle
5 • Proprietary small - molecule • Highly selective cancer and CSC targeting • Uptake and prolonged retention in malignant cells – POC in broad range of cancers • Ability to attach diverse oncologic payloads • Extensive research and peer reviewed scientific validation Basis for PDC Delivery Platform
Slide 6: PDC Delivery Platform Overview
6 Proprietary Small - Molecule, Cancer - Targeting Delivery Vehicle PDC D elivery Platform Overview + + Linker = Increased Therapeutic Window Drug Linker Drug Phospholipid Ether Enabling Targeted Delivery of Diverse Oncologic Payloads PDC Cancer Selective Versatile Chemistry Payload Diversity
Slide 7: PDC Cancer Targeting Validation in Broad Range of Cancers
7 PDC Cancer Targeting Validation in Broad Range of Cancers Demonstrated Clinical Translation In Vitro Mechanistic POC • Uptake Via Lipid Rafts • Cytoplasm & Cell Organelle Uptake • Prolonged Retention In Vivo POC • 60+ Cancer & CSC Models • Therapeutics & Imaging In Human Data • 50+ Patients • 10+
Slide 8: PDC Diverse Payload Delivery Validation
8 PDC Diverse Payload Delivery Validation Radioisotopes for Cancer Imaging • CLR 124: Glioma • Iodine - 123 Fluorophores for Imaging - Guided Surgery • CLR 1502 (near - infrared spectrum) • CLR 1501 (visible spectrum) Cytotoxins for Improved Therapeutic Index • CLR 1601 - PTX: Paclitaxel - pre - cli
Slide 9: PDC Cancer Targeting & Payload Delivery
9 PDC Cancer Targeting & Payload Delivery Antibody - Drug Conjugates (ADCs) Phospholipid Ether - Drug Conjugates (PDCs) Extracellular Space Intracellular (Cytoplasm) Antigen Antibody Lipid rafts Lipid rafts Antigen (+/ - ) Targeting : Lipid rafts Delivery : Cell cytoplasm Cancer stem cells Targeting
Slide 10: PDC Delivery Platform Summary
10 PDC Delivery Platform Summary DELIVERY VEHICLE PDC ADC Description PLE: Small - Molecule Antibody: Biologic Manufacturing Cost/Complexity Low High Cancer Targeting Cancer Selective Antigen Selective -- Cancer Stem Cell Yes ? -- Brain Metastases Yes ? Cancer Cell Uptake Membrane - Cytoplasm Antige
Slide 11: CLR 131: Lead PDC Radiotherapeutic Product
11 CLR 131: Lead PDC Radiotherapeutic Product • Payload: Iodine 131 – Cytotoxic r adioisotope – Thyroid cancer • PDC: CLR 131 – Targeted cytotoxic delivery – Tumor uptake, retention and efficacy demonstrated in vivo • Liquid and solid tumors – Solid tumor MTD established and activity observed – Indi
Slide 12: Market Opportunity in Multiple Myeloma
12 Market Opportunity in Multiple Myeloma • Incurable hematologic cancer - malignant plasma cells • Unmet need in relapse/refractory setting • 2 nd most common hematologic cancer – Prevalence ~ 90,000 – Incidence ~ 26,850 – Relapse/Refractory ~ 13,000 • Global MM drug m arket – 2014 - 2019 8.5% CAGR
Slide 13: CLR 131: Rationale for Multiple Myeloma
13 CLR 131: Rationale for Multiple Myeloma • Novel mechanism of action • Single dose treatment • Established radiosensitivity • In vivo MM cell uptake • Quantitative response criteria – M - protein marker • Regulatory Pathway – Unmet need in relapse/refractory patients – Orphan designation granted –
Slide 14: Phase Study in Multiple Myeloma Underway
14 Phase 1 Study in Multiple Myeloma Underway • Multi - center, open label, dose escalation trial initiated Q2 2015 – D etermine Phase II dose • 3rd line relapse/refractory patients • Primary objective: Dose limiting toxicity • Secondary objective: Efficacy • Next Steps – Evaluate cohort 1 - 1H 2016
Slide 15: PDC Chemotherapeutic Program Overview
15 PDC Chemotherapeutic Program Overview • Objective – Develop chemotherapy PDCs with improved efficacy & tolerability • Clinical Rationale – Numerous chemotherapeutics available for PDC – Highly effective yet highly toxic drugs – Improve drug therapeutic index through targeted delivery • Business R
Slide 16: CLR 1601-PTX: Pre-Clinical PDC Chemotherapeutic Product
16 CLR 1601 - PTX: Pre - Clinical PDC Chemotherapeutic Product • Payload: Paclitaxel – Well characterized chemotherapeutic – Breast, lung and ovarian cancers • PDC: CLR 1601 - PTX – Multiple derivatives developed – Established linker and Conjugation – I n vitro studies document: • Stability • Retent
Slide 17: CLR 1502: Phase I PDC Cancer Diagnostic Product
17 CLR 1502: Phase I PDC Cancer Diagnostic Product • Payload: Fluorophore – Fluorescent dye: Assess tissue perfusion • PDC: CLR 1502 – Cancer surgery i maging agent – Accurate visualization of tumor margins • Breast Cancer/Lumpectomy – Complete malignant tissue removal – Improved patient outcomes &
Slide 18: CLR 124: Phase II PDC Cancer Diagnostic Product
18 CLR 124: Phase II PDC Cancer Diagnostic Product • Payload: Iodine 124 – PET/CT imaging isotope – Limited cancer use • PDC: CLR 124 – More precise cancer imaging diagnostic – Early detection, staging, monitoring – Prostate , colorectal, head & neck , other – Brain cancer, glioma & metastases • Nex
Slide 19: Intellectual Property Portfolio
19 Intellectual Property Portfolio Patent Composition of Matter Methods of Use Methods of Manufacturing Freedom to Operate Asset CLR 131 12/2016 Orphan Drug - Multiple Myeloma 2025 - Cancer, Solid Tumors 2030 - Cancer Stem Cell 2028 CLR 124 12/2016 Orphan Drug - Glioma 2025 - Cancer TRX 2028 CLR 150
Slide 20: Near Term Milestones
20 Near Term Milestones PDC Product Candidate Indications Near Term Milestone Q4 2015 Q1 2016 Q2 2016 CANCER THERAPEUTICS CLR 131 RR Multiple Myeloma Cohort 1 Data & Initiate Cohort 2 CLR 1601 - PTX Breast & Lung Pre - Clinical Data Update CLR 1605 - GEM Pancreatic, Other Pre - Clinical Data Update
Slide 21: Summary Financial Outlook: Capitalization
21 Summary Financial Outlook Capitalization Common Stock Outstanding 7,562,762 Warrants (exercisable: $3.75 - $25.00) 6,604,096 Options 839,936 Fully Diluted 15,006,794 $4.8 M cash at June 30, 2015
Slide 22: Company Leadership
22 Company Leadership Management Jim Caruso President, CEO and Director HIP Innovation Technology - EVP & COO; Allos Therapeutics - EVP & COO; BCI, Novartis, BASF, BMS Jamey Weichert, PhD Company Founder, CSO, and Director University of Wisconsin Associate Professor of the Departments of Radiology,
Slide 23: Investment Overview
23 Investment Overview • Oncology - focused biopharmaceutical company in Madison, WI • First and best - in - class PDC delivery platform – Phospholipid ether Drug Conjugate (PDC) – Cancer - targeting delivery of oncologic payloads • Pipeline of cancer therapeutics and diagnostics • New leadership de