Cellectar Biosciences, Inc. · NASDAQ:CLRB
Cellectar Biosciences — IPO Roadshow (March 2016)
27 slides from Cellectar Biosciences's IPO roadshow presentation, Mar 25, 2016
Slide 1: Cellectar Biosciences Issuer Free Writing Prospectus
1 Cellectar Biosciences NASDAQ: CLRB Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration Statement No. 333 - 208638 March 25, 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: Offering and Registration Statement Notice
3 • This presentation highlights basic information about us and the offering. Because it is a summary that has been prepared sole ly for informational purposes, it does not contain all of the information that you should consider before investing in our company. Exc ept as otherwise indicated, this p
Slide 4: Transaction Overview
4 Transaction Overview Issuer: ▪ Cellectar Biosciences, Inc. Exchange: ▪ NASDAQ : CLRB Offering Size: ▪ $6 million Securities Offered: ▪ Common Stock, Series A Warrants, Series B Pre - funded Warrants Use of Proceeds: ▪ Research & Development o Further clinical development of CLR 131 o The pre - cli
Slide 5: Company Leadership
5 Company Leadership Management Jim Caruso President, CEO and Director Previously: HIP Innovation Technology - EVP & COO; Allos Therapeutics - EVP & CCO Chad Kolean CFO Previously: Pioneer Surgical Technology - CFO Kevin Kozak, MD, PhD CMO - Consultant Mercy Regional Cancer Center - Director of Radi
Slide 6: Company Overview
6 Company Overview • Oncology - focused biopharmaceutical company in Madison, WI • Developing Phospholipid Drug Conjugate (PDC) Delivery Platform – Phospholipid Ether cancer - targeting vehicle – Enables delivery of diverse oncologic payloads – Increases payload therapeutic window • R&D pipeline of
Slide 7: Company Developments and 2016 Outlook
7 Company Developments October 1, 2015 - Present 2016 Outlook $3.3M Financing 10/1/15 CTX Program Update Q2 $2.3M NCI Fast Track Grant - CLR 125 Study Initiated 10/1/15 CTX Patent Publication Q2 CTX Patent Application Conversion 11/10/15 Completion of Phase 1 NCI Fast Track Grant Q2 Initiated Pierre
Slide 8: Basis for PDC Delivery Platform
8 • Proprietary phospholipid ether small - molecule • Highly selective cancer and cancer stem cell 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
Slide 9: PDC Diverse Payload Delivery Validation
9 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 1602 - PTX: Paclitaxel • CLR CTX Development Program Other Payloads
Slide 10: PDC Cancer-Targeting Validation in Broad Range of Cancers
10 PDC Cancer - Targeting Validation in Broad Range of Cancers Demonstrated Clinical Translation In Vitro Mechanistic POC • Cellular Uptake via Lipid Rafts • Delivery to Cytoplasm & Cell Organelles • Prolonged Retention of Molecule within Malignant Cells In Vivo POC • Selective Uptake demonstrated i
Slide 11: PDC Cancer-Targeting and Payload Delivery
11 PDC Cancer - Targeting and Payload Delivery Phospholipid Drug Conjugates (PDCs) Extracellular Space Intracellular (Cytoplasm) Antigen Lipid rafts Lipid rafts Antigen (+/ - ) Targeting : Lipid rafts Delivery : Cell cytoplasm
Slide 12: PDC Delivery Platform Overview
12 PDC Delivery Platform Overview + + Linker = Drug Linker Drug Phospholipid Ether Enabling Targeted Delivery of Diverse Oncologic Payloads PDC Cancer Targeting Vehicle Options for Versatile Linker Chemistry Ability to Link Diverse Range of Payloads Phospholipid Drug Conjugate PDC Complex, Allowing
Slide 13: PDCs Represent a New Class of Cancer Targeting & Payload Delivery
13 PDCs Represent a New Class of Cancer Targeting & Payload Delivery PDC Delivery Platform Summary DELIVERY PLATFORM PDC: Cellectar ADCs Description & Manufacturing Cost/Complexity PLE: Small - Molecule Antibody: Biologic Cancer Targeting Cancer Selective Antigen Selective Targeting Mechanism Membra
Slide 14: PDC Product Development Pipeline
14 PDC Product Development Pipeline PDC Program Payload Indication Discovery Phase I Phase II CLR 131 Iodine - 131 Multiple Myeloma Pre - clinical CLR 125 1 Iodine - 125 Micrometast. Disease CLR CTX NP cytotoxics TBD CLR 1602 - PTX PTX CLR CTX PTX, GEM, GEL 2 Performance - based Performance - based
Slide 15: CLR 131: Lead PDC Radiotherapeutic Product
15 CLR 131: Lead PDC Radiotherapeutic Product • Payload: Iodine - 131 – Cytotoxic radioisotope – Thyroid cancer Tx • PDC: CLR 131 – Targeted cytotoxic delivery – Solid tumor maximum tolerated dose (MTD) established and activity observed (≤ 31.25mCi/m 2 ) 1 – Indications beyond thyroid cancer Tx • Mu
Slide 16: CLR 131: Clinical Rationale For Multiple Myeloma
16 CLR 131: Clinical Rationale For Multiple Myeloma • Multiple Myeloma – Incurable hematologic cancer – Orphan Designation – Unmet need in relapsed/refractory setting – Medium patient age is 70 years for MM 1 – Quantitative response criteria – M - protein marker – Free Light Chain (FLC) • CLR 131 –
Slide 17: CLR 131: Phase 1 Multiple Myeloma Study Overview
17 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 18: CLR 131: Cohort #1 Patient Summary
18 CLR 131: Cohort #1 Patient Summary Patient Number Prior Treatments Age Adverse Events ≥ Grade 2 IMWG 1 Response Assessment Progression Free Survival 101 12 Systemic Regimens 55 Decreased Neutrophils Anemia Decreased WBC 2 3 3 Stable Disease 64 Days 102 2 3 Systemic Regimens 74 None Progressive Di
Slide 19: CLR 131: Cohort #1 Patient Efficacy
19 CLR 131: Cohort #1 Patient Efficacy % Change from Baseline 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 - Protein # o
Slide 20: CLR 131: Market Rationale for Multiple Myeloma
20 CLR 131: Market Rationale for Multiple Myeloma • Unmet need remains in the relapsed or refractory setting • 2 nd most common hematologic cancer 1 – Prevalence ~ 90,000 1 – Incidence ~ 26,850 – Relapsed/Refractory ~ 13,000 1 • Global MM drug market 1 – $7.3B (2014) - $8.9B (2021) – Premium pricing
Slide 21: PDC Chemotherapeutic Program Overview
21 PDC Chemotherapeutic Program Overview • Objective – Develop chemotherapy PDCs with improved efficacy & tolerability – Convert non - targeted drugs to targeted chemotherapeutics • Clinical rationale – Chemotherapeutics highly effective, yet highly toxic drugs – Improve drug therapeutic index throu
Slide 22: Pierre Fabre PDC Chemotherapeutic Collaboration
22 Pierre Fabre PDC Chemotherapeutic Collaboration • Initiated 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
Slide 23: PDC Chemotherapeutic Program Status
23 PDC Chemotherapeutic Program Status • Initial chemotherapeutic payload candidates • PDCs synthesized – Five different payloads, multiple linkers and analogs • In vitro studies – Multiple PTX and GEL PDC analogs – 12 tumor cell lines – Has shown plasma stability and cytotoxic activity • Lead PDC s
Slide 24: CLR 1602-PTX: Pre-Clinical PDC Chemotherapeutic
24 CLR 1602 - PTX: Pre - Clinical PDC Chemotherapeutic • Payload: Taxol – Well characterized chemotherapeutic – Breast, lung and ovarian cancers • PDC: CLR 1602 - PTX – Developed linker and conjugation – Formulation without Cremophor El® – Larger scale synthesis • Established process for targeted de
Slide 25: CLR 125: Pre-Clinical PDC Radiotherapeutic Product
25 CLR 125: Pre - Clinical PDC Radiotherapeutic Product • Payload: Iodine - 125 – Cytotoxic radioisotope – Prostate brachytherapy Tx • PDC : CLR 125 – Targeted cytotoxic delivery – Micrometastatic disease – Lower hematological toxicity 1 • Development – F unded by a $2.3M NCI SBIR grant – S mall /di
Slide 26: Financial Summary
26 Financial Summary Capitalization as of March 2016 1 Common Stock Outstanding 858,013 Warrants (exercisable: $22.00 - $250.00) 861,314 Options 70,916 Fully Diluted 1,790,243 $3.9M cash at December 31, 2015 1 On March 4, 2016, the Company effected a reverse stock split at a ratio of 1 - for - 10. A
Slide 27: Company Developments and 2016 Outlook
27 Company Developments October 1, 2015 - Present 2016 Outlook $3.3M Financing 10/1/15 CTX Program Update Q2 $2.3M NCI Fast Track Grant - CLR 125 Study Initiated 10/1/15 CTX Patent Publication Q2 CTX Patent Application Conversion 11/10/15 Completion of Phase 1 NCI Fast Track Grant Q2 Initiated Pierr