Cellectar Biosciences, Inc. · NASDAQ:CLRB
Cellectar Biosciences — IPO Roadshow (August 2014)
40 slides from Cellectar Biosciences's IPO roadshow presentation, Aug 4, 2014
Slide 1: Cellectar Biosciences July 2014
1 Cellectar Biosciences July 2014
Slide 2: Safe Harbor Statement
2 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 uncerta
Slide 3: Registration statement legend
3 3 The issuer has filed a registration statement (including a prospectus) with the SEC for the offering to which this communication relates . Before you invest, you should read the prospectus in that registration statement and other documents the issuer has filed with the SEC for more complete info
Slide 4: Offering Overview
4 4 Offering Overview Issuer Cellectar Biosciences, Inc. Exchange: Ticker NasdaqCM : CLRB and CLRBW Offering Size Approximately $16,000,000 of Common Stock (100% Primary) Use of Proceeds Proceeds will be used to fund our research and development activities, including furthering the development of I
Slide 5: Overview
5 5 Overview • 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 technology is based on extensive research by technology founders and independent academic researc
Slide 6: Management Team
6 6 Management Team • Executive Team: • Simon Pedder, PhD : President, CEO and Director • Chelsea Therapeutics - CEO; Hoffmann - La Roche - Director of International Clinical Science, Director of International Clinical Operations, Global Project Leader of Pharmaceutical Development, Life Cycle Leade
Slide 7: Overview
7 7 Overview • Three Key Clinical Data Milestones By Year - end 2015 • H1 15: Phase II Imaging trial of I - 124 - CLR1404 in glioblastoma • YE 15 : PI/II trial of I - 131 - CLR1404 in multiple myeloma • YE: 15 PI POC trial of CLR1502 in breast cancer surgery • Established In - house Manufacturing C
Slide 8: Near Universal Cancer-Targeting Platform
8 8 Near Universal Cancer - Targeting Platform I - 124 - CLR1404 Potential Future Products Other imaging and therapeutic payloads Therapy Products in Development Optical imaging PET imaging Proprietary Phospholipid Ether (PLE) Analog Cancer - Targeting Vehicle Payload Cancer - Targeted Payload CLR15
Slide 9: Phospholipid Ether (PLE) Analogs
9 9 Phospholipid Ether (PLE) Analogs • Five Unique Attributes: x Selectively taken up by cancer cells including cancer stem cells regardless of anatomic location within the body x Prolonged retention in cancer cells including cancer stem cells x Broad spectrum of cancers - selectively retained by >6
Slide 10: Selective Retention in Malignant Tissue
10 10 Selective Retention in Malignant Tissue µ PET scans: Head down/tail up with flank tumor Fiducial markers (arrows) 6h 24h 48h 72h 120h I - 124 - CLR1404 Tumor uptake evident in about 9h
Slide 11: PLEs: Targeting Cancer Stem Cells
11 11 PLEs: Targeting Cancer Stem Cell s • The New Paradigm in Cancer Therapy: Cancer Stem Cells Associated with Most, If Not All, Major Cancer Types • Chemotherapy and radiotherapy resistant • Affiliated with tumor regrowth and metastasis following chemo and radiation therapy • Tumor hypoxia stimul
Slide 12: A Broad View of Cancer
12 12 A Broad View of Cancer. A new class of imaging agents is taken up readily by nearly all human cancers, reports a new study by Weichert, Kuo, and colleagues in this issue of Science Translational Medicine. The agents, called APC analogs, were tagged with fluorescent or radioisotope labels for i
Slide 13: In-House Manufacturing Capabilities
13 13 In - House Manufacturing Capabilities • Our investment in manufacturing potentially allows complete control through clinical trials and registration • GMP manufacturing fully operational • Reliability for dosimetry dose demonstrated • Exceptionally high purity and radiochemical purity • Meets
Slide 14: Pipeline of Cancer-Targeting Compounds
14 14 COMPOUND / APPLICATION STAGE OF DEVELOPMENT H1 2014 H2 2014 H1 2015 H2 2015 I - 124 - CLR1404: Cancer PET Imaging Glioblastoma Phase II Phase III ---- > Brain Cancer (Investigator Sponsored) Phase I/ II Glioma (Investigator Sponsored) Phase I/ II Non - small Cell Lung Cancer - (Investigator Sp
Slide 15: PLE + PET Imaging Isotope = CLR1404
15 15 PLE + PET Imaging Isotope = I - 124 - CLR1404 More Accurate Tumor Imaging for Better Patient Management
Slide 16: CLR1404: PLE + PET Imaging Isotope
16 16 I - 124 - CLR1404: PLE + PET Imaging Isotope • Small - molecule imaging agent for primary tumors and metastases • Proprietary PLE attached to Iodine - 124 PET imaging isotope • Robust series of i nvestigator s ponsored Phase I/II trials underway at UW Carbone Cancer Center • Lung Cancer (Trayn
Slide 17: Initial Target: Glioblastoma
17 17 Initial Target: Glioblastoma • MRI is not able to reliably distinguish recurrent disease from pseudo - progression or radiation necrosis • MRI shows early post - treatment changes in ~50 % of glioblastoma patients • Nearly half of the time, early changes are non - malignant pseudo - progressio
Slide 18: Selective Detection of Malignant Tissue
18 18 Selective Detection of Malignant Tissue T - 1 post gad MRI of 60 year old melanoma patient initially diagnosed with radiation necrosis The images provided above are for illustrative purposes only and may not be indicative of all results.
Slide 19: Selective Detection of Malignant Tissue
19 19 Selective Detection of Malignant Tissue Gad T1 MRI + FDG PET I - 124 - CLR1404 suggests malignant lesion recurrence The images provided above are for illustrative purposes only and may not be indicative of all results. Subsequent follow - up demonstrated recurrence rather than radiation necros
Slide 20: Selective Detection of Malignant Tissue
20 20 Selective Detection of Malignant Tissue May identify disease volumes not detected by traditional MRI Full body scan of Non - Small Cell Lung Cancer Revealed 3 Undiagnosed Brain Metastasis The images provided above are for illustrative purposes only and may not be indicative of all results. Fus
Slide 21: Selective Detection of Malignant Tissue
21 21 Selective Detection of Malignant Tissue Comparison of I - 124 - CLR1404 PET(purple) - and Gd MRI - positive(yellow) volumes shows areas of discordance The images provided above are for illustrative purposes only and may not be indicative of all results. Video: I - 124 - CLR1404 PET/MRI 3D disc
Slide 22: Phase II Imaging Trial in Glioblastoma
22 22 Phase II Imaging Trial in Glioblastoma • Initiated Phase II trial March 2014 • Targeting 10 centers to enroll ~36 patients • Newly diagnosed or recurrent glioblastoma where SOC includes resection and/or biopsy • Compare performance of I - 124 - CLR1404 PET/CT to MRI with pathology confirmation
Slide 23: Scalable Commercial Opportunity for CLR1404
23 23 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 • Pancreat
Slide 24: PLE + Radiotherapeutic = I-131-CLR1404
24 24 PLE + Radiotherapeutic = I - 131 - CLR1404 Better targeted delivery to cancer cells and cancer stem cells
Slide 25: Better Targeting = Better Therapeutic Delivery
25 25 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 couple
Slide 26: Targeted Therapeutic Delivery
26 26 Targeted Therapeutic Delivery Transverse CT images through the lungs before (A) and 78 days after (B) injection of single 85 mCi dose of 131I - CLR1404 in 58 - year - old woman with metastatic triple - negative breast cancer A B 30% Reduction by volume in metastatic lesion The images provided
Slide 27: Multiple Myeloma
27 27 Multiple Myeloma • Attractive initial indication • Radiosensitivity • Uptake • Novel mechanism of action • Quantitative non - RECIST response criteria • Clear Go/No Go criteria; low cost, fast path to approval • Market Opportunity • High un - met need • Not cost - sensitive • Regulatory opport
Slide 28: PLE + Near-Infrared Fluorophore = CLR1502
28 28 PLE + Near - Infrared Fluorophore = CLR1502 Intraoperative Optical Imaging for Better Outcomes
Slide 29: CLR1502: Improving Surgical Outcomes
29 29 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 ti
Slide 30: Tumor Margin Illumination – Real Time Surgery
30 30 Tumor Margin Illumination – Real Time Surgery Fluobeam TM ) Fluoptics The images provided above are for illustrative purposes only and may not be indicative of all results. T T B B Photograph (left) and near infrared image (right) of an excised mouse brain (B) and human glioma stem cell derive
Slide 31: Unmet Medical Need – Breast Cancer Surgery
31 31 Unmet Medical Need – Breast Cancer Surgery • Lumpectomy - removal of tumor while sparing functional tissue • Challenging for surgeons to identify margins during surgery • When post - surgery pathology indicates malignant tissue remains, surgery repeated • 1 in 4 lumpectomies are repeated (U.S
Slide 32: CLR1502 Phase I: Breast Cancer Surgery
32 32 CLR1502 Phase I: Breast Cancer Surgery • Seeking US IND Q4 2014 • Trial Initiation 2015 • Expect data by year - end 2015 • Trial design • Dose - ranging multi - site, ~20 patients undergoing lumpectomy • Compatible with standard of care (SOC) – only addition is CLR1502 administration and non -
Slide 33: Summary Financial Outlook
33 33 Summary Financial Outlook • $1.6 M cash at June 30, 2014 Capitalization Common Stock Outstanding 2,869,739 Warrants (exercisable: $10.00 - $25.00) 1,564,085 Options 619,664 Convertible Debentures Shares ($10.00) 400,000 Warrants ($20.00) 400,000 Fully Diluted 5,853,488 Authorized 20,000,000
Slide 34: Upcoming Milestones
34 34 Upcoming Milestones • Q3 14: File IND for PI/II trial of I - 131 - CLR1404 in multiple myeloma • Q4 14: Seek orphan designation for I - 131 - CLR1404 in multiple myeloma • Q4 14: File IND for PI POC trial of CLR1502 in breast cancer surgery • Q4 14: Initiate PI/II trial of I - 131 - CLR1404 in
Slide 35: Appendix
VA CELLECTAR BIOSCIENCES Appendix FIND. TREAT. FOLLOW 35
Slide 36: Phospholipid Ether (PLE) Analogs
36 36 Phospholipid Ether (PLE) Analogs • Highly - Selective, Broad - Spectrum, Cancer Targeting Delivery Platform • Targets lipid rafts, a structure more abundant in malignant cells and malignant stem cells
Slide 37: Global Nuclear Medicine Market
37 37 Global Nuclear Medicine Market • P rojected to grow an average of 11% annually and reach $24 billion in 2030 • Diagnostic radiopharmaceuticals market: 5 % growth per year • Therapeutic radiopharmaceuticals: annual 30 % growth from 2014 to 2030 • Key growth driver is the aging demographic creat
Slide 38: Therapeutic response of myeloma xenograft to I-131-CLR1404
38 38 Therapeutic response of myeloma (MM1.S) xenograft to single dose of I - 131 - CLR1404 • Dose of 127 I - CLR1404 mass - equivalent to 131 I - CLR1404 dose • T umor volumes (mean ± SEM) show significant response 5 days after dosing of 100 microCi • No visually apparent tox signs, tx group shows
Slide 39: Building Robust Intellectual Property
39 39 Building Robust Intellectual Property • PLE Platform Patents/Applications: • Different forms of phospholipid ethers • M ethods of manufacturing of phospholipid ethers • Freedom to Operate Analysis • Recently completed FTO analysis for I - 124 - CLR1404, I - 131 - CLR1404 and CLR1502 and found
Slide 40: Building Robust Intellectual Property
40 40 Building Robust Intellectual Property • I - 131 - CLR1404 • Plan to request orphan designation for multiple myeloma: 7 years exclusivity from US approval in this indication • Composition of matter: 2016 (University of Michigan) • Method of use: • Cancer therapy (1 issued, 1 pending US patents;