Cellectar Biosciences, Inc. · NASDAQ:CLRB
Cellectar Biosciences — Investor Presentation (March 2014)
30 slides from Cellectar Biosciences's investor presentation, Mar 19, 2014
Slide 1: Cellectar Biosciences March 2014
Cellectar Biosciences March 2014
Slide 2: Safe Harbor Statement
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 uncertainti
Slide 3: A New Name for a "New" Company
A New Name for a “New” Company • Leveraging highly selective delivery and retention platform to develop novel agents to detect, treat and monitor a broad spectrum of cancers • Cellectar’s Phospholipid Ether ( PLE) Analog discoveries are based on extensive research by technology founders and independ
Slide 4: Strategic Realignment: Streamlined Board of Directors
Strategic Realignment • Streamlined Board of Directors, adding new director and reducing overall size from 9 to 5 members • Stephen A. Hill, B.M. B.Ch ., M.A., F.R.C.S., Chairman of the Board of Directors • Simon Pedder, Ph.D., CEO and Director • Jamey Weichert, Ph.D., Chief Scientific Officer, Tech
Slide 5: Strategic Realignment: Aligning Resources with Strategic Priorities
Strategic Realignment • Aligning Resources with Strategic Priorities • Relocating Executives Offices and Centralizing Operations in Madison, WI • Responsibilities of former MA based VP, Clinical Development and VP, Research and Development being transitioned to existing WI - based employees • Transi
Slide 6: Cellectar At a Glance
Cellectar At a Glance • Proprietary cancer - targeting delivery platform with potential to image and treat a wide range of solid tumors • Tumor Imaging - More accurate for better patient management • Therapy - Better targeted delivery to cancer cells and cancer stem cells • Surgery - Intraoperative
Slide 7: Near Universal Cancer Target Platform
Near Universal Cancer Target Platform • Phospholipid Ether (PLE) Analogs: Highly - Selective, Broad - Spectrum, Cancer Targeting Delivery Platform with Multi - Product Diagnostic and Therapeutic Applications • Targets lipid rafts, a structure over expressed by malignant cells and malignant stem cell
Slide 8: Near Universal Cancer-Targeting Platform: Potential Future Products
Near Universal Cancer - Targeting Platform I - 124 - CLR1404 Potential Future Products • Other imaging and therapeutic payloads CLR1502 I - 131 - CLR1404 Therapy Cancer - Targeting Vehicle Payload Cancer - Targeted Payload 124 I Products in Development IR - 775 131 I * Optical imaging PET imaging Pr
Slide 9: Targeting Stem Cell-Based Relapse
Near Universal Cancer Target Platform • The New Paradigm in Cancer Therapy: Targeting Stem Cell - Based Relapse • Cancer Stem Cells Associated with Most, If Not All, Major Cancer Types • Chemotherapy resistant • Affiliated with tumor regrowth and metastasis following chemo and radiation therapy • Gl
Slide 10: I-124-CLR1404 Tumor Time Course
I - 124 - CLR1404 Tumor Time Course µ PET scans: Head down/tail up with flank tumor Fiducial markers (arrows) 6h 24h 48h 72h 120h Tumor uptake evident in about 9h
Slide 11: In-House Manufacturing Capabilities
In - House Manufacturing Capabilities • Our investment in manufacturing allows complete control through clinical trials • GMP manufacturing fully operational • Reliability for dosimetry dose demonstrated • Exceptionally high purity and radiochemical purity • CMC meets NDA standards • Easy , fast and
Slide 12: PLE + PET Imaging Isotope = I-124-CLR1404
PLE + PET Imaging Isotope = 124 I - CLR1404 More Accurate Tumor Imaging for Better Patient Management
Slide 13: I-124-CLR1404: PLE + PET Imaging Isotope
124 I - CLR1404: PLE + PET Imaging Isotope • Small - molecule imaging agent for primary tumors and metastases • Proprietary PLE attached to I - 124 PET imaging isotope • Phase I/II trials underway at UW Carbone Cancer Center ( investigator sponsored) • Lung Cancer (Traynor/Perlman) • Glioma/ Brain t
Slide 14: Initial Target: Brain Cancer Imaging
Initial Target: Brain Cancer Imaging • Significant unmet clinical need • MRI is unable to distinguish recurrent disease from pseudo - progression • MRI is current Standard of Care (SOC) • MRIs show post - treatment changes in ~50% of all patients • Nearly half of the time, this signal is non - malig
Slide 15: Clearly Images Brain Metastases
Clearly Images Brain Metastases I - 124 - CLR1404 PET scan identified 3 brain metastases in an asymptomatic NSCLC patient • Treatment plan subsequently altered 3D Projection View Single Slice I - 124 - CLR1404 PET Image (Day 6 post - dose at 5 mCi) The images provided above are for illustrative purp
Slide 16: Phase II Imaging Trial in Glioma
Phase II Imaging Trial in Glioma • Initiated Phase II trial March 2014 • 10 NCI - designated centers enrolling ~36 patients • Newly diagnosed or recurrent glioma where SOC includes resection and/or biopsy • Compare performance of 124I - CLR1404 PET/CT to MRI with pathology confirmation • Approval ba
Slide 17: Scalable Commercial Opportunity for I-124-CLR1404
Scalable Commercial Opportunity for I - 124 - CLR1404 • Establish efficacy in primary glioma • Pursue additional solid tumors with initial positive images: • Prostate ~239k patients • Breast ~235k patients • Lung ~228k patients • Colorectal ~102k patients • Head & Neck ~54k patients • Pancreatic ~45
Slide 18: PLE + Radiotherapeutic = I-131-CLR1404
PLE + Radiotherapeutic= 131 I - CLR1404 Better targeted delivery to cancer cells and cancer stem cells
Slide 19: Better Targeting = Better Therapeutic Delivery
Better Targeting=Better Therapeutic Delivery • Proprietary cancer - targeting delivery vehicle (PLE) attached to proven radiotherapeutic • Iodine - 131, well - established as a cancer therapeutic – FDA familiarity • Preclinical single - dose data demonstrates remarkable in vivo efficacy coupled with
Slide 20: I-131-CLR1404: Phase Ia
I - 131 - CLR1404: Phase Ia • Results provided starting dose for MTD therapy trial • Eight patients enrolled; four cancer types • Zero drug attributable serious adverse events • Consistent biodistribution from patient to patient • Distribution and elimination as predicted from animal studies; minima
Slide 21: Future Development Pathway is Attractive Partnering Opportunity
Future Development Pathway is Attractive Partnering Opportunity • A nti - tumor/survival - prolonging activities demonstrated in more than a dozen models • Multiple Myeloma as potential initial indication • Radiosensitivity • Uptake • Novel mechanism of action • Quantitative non - RECIST response cr
Slide 22: Therapeutic response to a single dose of I-131-CLR1404
Therapeutic response to a single dose of 100 m Ci 131 I - CLR1404 • Dose of 127 I - CLR1404 mass - equivalent to 131 I - CLR1404 dose • Tumor volumes (mean ± SEM) show significant response 5 days after dosing of 100 mCi • No visually apparent tox signs, tx group shows 5% weight loss & is slightly mo
Slide 23: PLE + Near-Infrared Fluorophore = CLR1502
PLE + Near - Infrared Fluorophore = CLR1502 Intraoperative Optical Imaging for Better Outcomes
Slide 24: CLR1502: Improving Surgical Outcomes
CLR1502: Improving Surgical Outcomes • Optical imaging agent for intraoperative tumor margin illumination • Proprietary cancer - targeting delivery vehicle (PLE) attached to near - infrared fluorophore • More accurate visualization of tumor margins during surgery for more complete malignant tissue r
Slide 25: Tumor Margin Illumination: Real Time Surgery Optical Imaging
Tumor Margin Illumination – Real Time Surgery Optical Imaging (800nm) Non - Invasive Tumor Imaging Intraoperative Tumor Margin Illumination in Real Time No residual tumor Fluobeam TM ) Fluoptics The images provided above are for illustrative purposes only and may not be indicative of all results.
Slide 26: Unmet Medical Need: Breast Cancer Surgery
Unmet Medical Need – Breast Cancer Surgery • Lumpectomy - removal of tumor and nodal involvement while sparing functional tissue • Challenging for surgeons to identify margins during surgery • When post - surgery pathology indicates malignant tissue remains, surgery repeated • One in four lumpectomi
Slide 27: CLR1502 Phase I: Breast Cancer Surgery
CLR1502 Phase I: Breast Cancer Surgery • Seeking US IND H1 2014 and Trial Initiation H2 2014 • Trial design • Dose - ranging multi - site, ~20 patients undergoing lumpectomy • Compatible with standard of care (SOC) – only addition is CLR1502 administration and non - invasive optical imaging • Primar
Slide 28: Summary Financial Outlook
Summary Financial Outlook • $2.4M cash at December 31, 2013 • Closed additional $4.0 million placement of convertible notes and warrants February 6 th , 2014 • Capitalization • Common Stock Outstanding 57,397,997 • Warrants (exercisable; $0.50 - $1.25) 31,282,459 • Options 12,229,585 • Convertible D
Slide 29: Opportunity Summary
Opportunity Summary • $Billion+ potential aggregate markets:I - 124 - CLR1404 and CLR1502 • Proof - of - Concept data expected in 12 - 18 months • Opportunity for meaningful value transformation • Therapeutic (I - 131 - CLR1404) represents additional potential upside • Compelling data package to sup
Slide 30: Going Forward
Going Forward • Meaningful development opportunities • Compelling near - and long - term opportunities • Near - term Data Points • I - 124 - CLR1404 Phase II Imaging Data in Glioma • I - 131 - CLR1404 Phase Ib Safety Data • CLR1502 Phase I Optical Imaging Data • Long - term: opportunity to expand de
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