Cellectar Biosciences, Inc. · NASDAQ:CLRB
Cellectar Biosciences — Investor Presentation (January 2016)
30 slides from Cellectar Biosciences's investor presentation, Jan 11, 2016
Slide 1: Cellectar Biosciences
1 Cellectar Biosciences NASDAQ: CLRB January 11, 2016
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 • Phospholipid Drug Conjugate (PDC) Delivery P latform – Phospholipid Ether cancer - targeting v ehicle – Enables delivery of diverse oncologic payloads – Increases payload therapeutic window • Pipeline of PDC cancer
Slide 4: Phospholipid Ether Cancer-Targeting Vehicle
4 • 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 5: PDC Cancer-Targeting Validation in Broad Range of Cancers
5 PDC Cancer - Targeting Validation in Broad Range of Cancers Demonstrated Clinical Translation In Vitro Mechanistic POC • Lipid Raft Uptake • Cytoplasm & Cell Organelle Delivery • Prolonged Retention In Vivo POC • 60 + Cancer & CSC Models • Therapeutics & Imaging In Human Data • 70 + Patients • 10+
Slide 6: PDC Diverse Payload Delivery Validation
6 PDC Diverse Payload Delivery Validation Radioisotopes for Cancer Imaging • CLR 124: Glioma • Iodine - 123 Fluorophores for Imaging - Guided Surgery • CLR 1502: Optical Imaging • CLR 1501 Chemotherapeutics for Cancer Therapy • CLR 1603 - PTX: Paclitaxel • CLR CTX Development Program Other Payloads
Slide 7: PDC Delivery Platform Overview
7 PDC D elivery Platform Overview + + Linker = Increased Therapeutic Window Drug Linker Drug Phospholipid Ether Enabling Targeted Delivery of Diverse Oncologic Payloads PDC Cancer Targeting Vehicle Versatile Chemistry Payload Diversity Phospholipid Drug Conjugate
Slide 8: PDC Cancer-Targeting and Payload Delivery
8 PDC Cancer - Targeting and Payload Delivery Antibody - Drug Conjugates (ADCs) Phospholipid Drug Conjugates (PDCs) Extracellular Space Intracellular (Cytoplasm) Antigen Antibody Lipid rafts Lipid rafts Antigen (+/ - ) Targeting : Lipid rafts Delivery : Cell cytoplasm Cancer stem cells Targeting: Tu
Slide 9: PDCs Represent a New Class of Cancer Targeting & Payload Delivery
9 PDCs Represent a New Class of Cancer Targeting & Payload Delivery PDC Delivery Platform Summary DELIVERY PLATFORM PDC ADC Description PLE: Small - Molecule Antibody: Biologic Manufacturing Cost/Complexity Low High Cancer Targeting Cancer Selective Antigen Selective -- Cancer Stem Cell Yes ? -- Bra
Slide 10: PDC Product Development Pipeline
10 PDC Product Development Pipeline PDC Program Payload Indication Discovery Phase I Phase II CLR 131 Iodine - 131 Multiple Myeloma Preclinical CLR 125* Iodine - 125 Micrometast. Disease CLR CTX NP cytotoxics (Undisclosed) Undisclosed CLR 1603 - PTX PTX CLR CTX PTX, GEM, GEL Performance - based Perf
Slide 11: CLR 131: Lead PDC Radiotherapeutic Product
11 CLR 131: Lead PDC Radiotherapeutic Product • Payload: Iodine - 131 – Cytotoxic r adioisotope – Thyroid cancer Tx • PDC: CLR 131 – Targeted cytotoxic delivery – Tumor uptake, retention and efficacy demonstrated in human (N=23) • Liquid and solid tumors – Solid tumor MTD established and activity ob
Slide 12: CLR 131: Clinical Rationale For Multiple Myeloma
12 CLR 131: Clinical Rationale For Multiple Myeloma • Multiple Myeloma – Incurable hematologic cancer – Orphan Designation – Unmet need in relapsed/refractory setting – Patient Demographics – Quantitative response criteria – M - protein marker – Free Light Chain (FLC) • CLR 131 – Established radiose
Slide 13: CLR 131: Clinical/Regulatory Rationale For Multiple Myeloma
13 CLR 131: Clinical/Regulatory Rationale For Multiple Myeloma • Regulatory pathway – Orphan designation granted – Potential for fast track, breakthrough therapy, accelerated approval 13 Response Rate by Line of Therapy 0 25 50 75 100 1st 2nd 3rd+ Response Rate % Line of Therapy 0 6 12 18 24 30 36 1
Slide 14: CLR 131: Phase 1 Multiple Myeloma Study Overview
14 CLR 131: Phase 1 Multiple Myeloma Study Overview • Multi - center, open label, dose escalation trial initiated Q2 2015 • Relapsed or refractory patients • Primary objective: – Characterize safety & tolerability • Secondary objectives: – Establish phase II dose – Assess therapeutic activity • Firs
Slide 15: CLR 131: Cohort #1 Patient Performance
15 CLR 131: Cohort #1 Patient Performance Treated Patients Prior Treatment Age AE’s Disease Assessment 1 Stable Disease Duration 1 12 Systemic Regimens 55 Flushing 1 Anemia 3 Stable 43 Days 2 3 Systemic Regimens 1 Radiation Treatment 74 None Not Assessed N/A 3 3 Systemic Regimens 70 Nausea 1 Sinus B
Slide 16: CLR 131: Cohort #1 Patient Performance % Change from Baseline
16 CLR 131: Cohort #1 Patient Performance % Change from Baseline 16 Patient #3 Patient #5 -70.0% -60.0% -50.0% -40.0% -30.0% -20.0% -10.0% 0.0% 131 Dose % Change from Baseline Free Light Chain Assay # of Days 1 22 43 64 85 -35.0% -30.0% -25.0% -20.0% -15.0% -10.0% -5.0% 0.0% 131 Dose Serum M - Prote
Slide 17: CLR 131: Market Rationale for Multiple Myeloma
17 CLR 131: Market Rationale for Multiple Myeloma • Unmet need remains in the relapsed or refractory setting • 2 nd most common hematologic cancer – Prevalence ~ 90,000 – Incidence ~ 26,850 – Relapsed/Refractory ~ 13,000 • Global MM drug m arket – 2014 - 2019 5 - 8.5% CAGR • Premium pricing for mark
Slide 18: CLR 125: Pre-Clinical PDC Radiotherapeutic Product
18 CLR 125: Pre - Clinical PDC Radiotherapeutic Product • Payload: Iodine - 125 – Cytotoxic radioisotope – Prostate brachytherapy Tx • PDC : CLR 125 – Targeted cytotoxic delivery – Micrometastatic disease • Uniquely efficacious – Lower hematological toxicity • Development – F unded by a $2.3M NCI SB
Slide 19: PDC Chemotherapeutic Program Overview
19 PDC Chemotherapeutic Program Overview • Objective – Develop chemotherapy PDCs with improved efficacy & tolerability • Clinical rationale – Chemotherapeutics highly effective, yet highly toxic drugs – Improve drug therapeutic index through targeted delivery – Cancer stem cell delivery – increased
Slide 20: PDC Chemotherapeutic Program Progress
20 PDC Chemotherapeutic Program Progress • Initial chemotherapeutic payload candidates – PTX, SAHA, GEM, GEL, MER • PDCs synthesized – Four different payloads, multiple linkers and analogs • In vitro studies – 12 tumor cell lines – Multiple PTX and GEL PDC analogs – Documented stability and cytotoxi
Slide 21: CLR 1603-PTX: Pre-Clinical PDC Chemotherapeutic
21 CLR 1603 - PTX: Pre - Clinical PDC Chemotherapeutic • Payload: Paclitaxel – Well characterized chemotherapeutic – Breast, lung and ovarian cancers • PDC: CLR 1603 - PTX – Established linker and conjugation – Lead PDC for R&D model • Future PDCs, new CTX payloads • Process for targeted delivery as
Slide 22: Pierre Fabre PDC Collaboration
22 Pierre Fabre PDC Collaboration • Announced December 2015 • Objectives – Co - design library of PDCs – Conduct in vivo POC studies – Evaluate therapeutic index vs. untargeted payloads • Pierre Fabre to provide payloads – Proprietary natural product - derived cytotoxics • Cellectar to lead conjugat
Slide 23: Company Milestones
23 Company Milestones Q3 2015 - Present Present - Q3 2016 Introduced PDC Delivery Platform - Therapeutic Focus - CTX Program - Collaboration Model Pierre Fabre Collaboration Update TBA $3.3M Financing CTX Program Update Q2 $2.3M NCI Fast Track Grant - CLR 125 Study Initiated CTX Patent Conversion Q2
Slide 24: Financial Summary
24 Financial Summary Capitalization Common Stock Outstanding 8,581,405 Warrants (exercisable: $2.20 - $25.00) 8,613,137 Options 723,933 Fully Diluted 17,918,475 $2.5 M cash at September 30, 2015 $2.9 M cash raised on October 1, 2015 $5.4 M cash at October 1, 2015
Slide 25: Company Leadership
25 Company Leadership Management Jim Caruso President, CEO and Director HIP Innovation Technology - EVP & COO; Allos Therapeutics - EVP & CCO; BCI, Novartis, BASF, BMS Jamey Weichert, PhD Company Founder, CSO, and Director University of Wisconsin Associate Professor of the Departments of Radiology,
Slide 26: Investment Overview
26 Investment Overview • Oncology - focused biopharmaceutical company in Madison, WI • Phospholipid Drug Conjugate (PDC) Delivery P latform – Phospholipid Ether cancer - targeting v ehicle – Enables delivery of diverse oncologic payloads – Increases payload therapeutic window • Pipeline of PDC cance
Slide 27: Appendix
27 Appendix
Slide 28: Intellectual Property Portfolio
28 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 125 12/2016 Orphan Drug - TBD 2025 - Cancer, Solid Tumors 2030
Slide 29: CLR 1502: Phase I PDC Cancer Diagnostic Product
29 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 30: CLR 124: Phase II PDC Cancer Diagnostic Product
30 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 • N
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