Cellectar Biosciences, Inc. · NASDAQ:CLRB
Cellectar Biosciences — IPO Roadshow (November 2016)
29 slides from Cellectar Biosciences's IPO roadshow presentation, Nov 14, 2016
Slide 1: Issuer Free Writing Prospectus
1 NASDAQ: CLRB Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration Statement No. 333 - 214310 November 14, 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 presentation notices
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: Company Overview
4 Company Overview • Oncology - focused Biopharmaceutical Company in Madison, WI • Rapid Company Transformation Effected in 2015 – Strategy and therapeutic product focus – Financial Efficiency - Improved R&D and SG&A expenses • Phospholipid Drug Conjugate (PDC) Delivery Platform – Phospholipid Ether
Slide 5: Phospholipid Ether Cancer-Targeting Vehicle
5 • Proprietary Small - molecule • Highly Selective Cancer and Cancer Stem Cell (CSC) Targeting • Uptake and Prolonged Retention in Malignant Cells – Proof of concept (POC) in broad range of cancers • Ability to Attach Diverse Oncologic Payloads • Extensive Research and Peer Reviewed Scientific Vali
Slide 6: PDC Delivery Platform Overview
6 PDC Delivery Platform Overview Validated Targeted Delivery of Diverse Oncologic Payloads Phospholipid Drug Conjugate (PDC) + + Linker = Linker Drug Phospholipid Ether (PLE) PDC Fluorophores Chemotherapeutics Radioisotopes Data source: In house data, on file.
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 • Lipid Raft Uptake • Cytoplasm & Cell Organelle Delivery • Prolonged Retention In Vivo POC • 70+ Cancer & CSC Models • Therapeutics & Imaging In Human Data • ~100 Patients • 10+
Slide 8: PDC vs. ADC Targeting & Payload Delivery
8 PDC vs. ADC Targeting & Payload Delivery Antibody - Drug Conjugates Phospholipid Ether - Drug Conjugates Target : Lipid rafts/ Caveolae Delivery : Cell cytoplasm Immunogenic: No Target: Tumor - specific antigens Delivery: Cell surface Immunogenic: Potentially PDCs Exploit An Unalterable Metabolic
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 Cancer Targeting Cancer Stem Cell Targeting Metastases Targeting Ability to Overcome Resistance Safety Cytoplasm Payload De
Slide 10: PDC Product Development Pipeline
10 PDC Product Development Pipeline PDC Program Payload Indication Discovery Phase I Phase II CLR 131 1 Iodine - 131 Multiple Myeloma Pre - IND Hematologic Malignancies CLR 1800 - P Proprietary TBD 2 CLR 1602 - PTX 3 Paclitaxel CLR 1700 TBD Performance - based Performance - based CLR 124 Iodine - 12
Slide 11: CLR 131: PDC Radiotherapeutic Overview
11 CLR 131: PDC Radiotherapeutic Overview • Targeted, Precision Radiotherapeutic – Novel mechanism of action • Phase I Maximum Tolerated Dose Study in R/R Multiple Myeloma – Demonstrates early signs of efficacy & excellent tolerability • Improved Performance From Cohort 1 to Cohort 2 – Progression -
Slide 12: CLR 131: MM Target Product Profile
12 CLR 131: MM Target Product Profile Treatment of relapse/refractory patients having received a minimum of 2 lines of prior therapy Improvement of Progression - Free Survival, Overall survival benefit Use with IMiD 1 and/or PI 2 in earlier lines of therapy Use in Combination Overall Clinical Succes
Slide 13: CLR 131: Clinical Development Strategy
13 CLR 131: Clinical Development Strategy • Near - term Hematologic Malignancy Focus – Indications with established radiosensitivity – Orphan designations – High rate of relapse/resistant disease settings – Niche opportunities with high unmet medical need • Multiple Myeloma – Incurable – Surrogate m
Slide 14: CLR 131: Non-dilutive NCI Funding
14 CLR 131: Non - dilutive NCI Funding
Slide 15: CLR 131: Phase I R/R Multiple Myeloma Study Overview
15 CLR 131: Phase I R/R Multiple Myeloma Study Overview • Multi - center, Open Label, Dose Escalation Trial Initiated Q2 2015 • Primary Objective: – Characterize safety & tolerability • Secondary Objectives: – Establish Phase II dose – Assess therapeutic activity • Dose Escalation < 2 of 6 DLT’s • 8
Slide 16: CLR 131: Cohort Patient Demographics
16 CLR 131: Cohort 1 & Cohort 2 Patient Demographics 1.Excludes patient with 12 prior lines 2. Includes patient 108 2 Grade 4s (disease progression) Demographic Metric Cohort #1 (12.5 mCi/m 2 ) Cohort #2 (18.75 mCi/m 2 ) Evaluable Patients 4 4 Average Age 68 69 Gender (Female:Male ) 1:3 2:2 Prior Tr
Slide 17: CLR 131: Cohort 1 Efficacy Markers
17 CLR 131: Cohort 1 (12.5 mCi/m 2 ) Efficacy Markers -12 -10 -8 -6 -4 -2 0 2 Screening D22 D43 D64 64 DAYS POST SINGLE DOSE AVERAGE REDUCTION FROM BASELINE (%) "Judging by the results of the first cohort, I believe there is significant potential for CLR 131 as a safe and tolerable treatment modalit
Slide 18: CLR 131: Cohorts 1 & 2 Efficacy Markers
18 CLR 131: Cohorts 1 (12.5 mCi/m 2 ) & 2 (18.75 mCi/m 2 ) Efficacy Markers Change from Baseline (%) Days Post Single Dose -80.0% -70.0% -60.0% -50.0% -40.0% -30.0% -20.0% -10.0% 0.0% 1 22 43 64 85 Free Light Chain (FLC) I - 131 D1 Partial Repsonse 1 1. IMWG Criteria, If Serum or Urine M - Proteins
Slide 19: CLR 131: Progression Free Survival Performance
19 0 20 40 60 80 100 120 140 Cohort 1 Cohort 2 PROGRESSION FREE SURVIVAL (DAYS) CLR 131 – PHASE I 0 20 40 60 80 100 120 140 POMALYST 1 DARATUMUMAB 2 PIVOTAL STUDY RESULTS PROGRESSION FREE SURVIVAL (DAYS) +30% 3 PFS For Cohort 2 Increased By 30% And Continues For 2 of 4 Patients COHORT 1 (12.5 mCi) C
Slide 20: CLR 131: Adverse Event Profile
20 CLR 131: Adverse Event Profile Adverse Events Avg. Number/Patient Avg. Grade/Patient Median Grade Cohort 1 (12.5) 4.75 2.00 + 0.91 2.0 Cohort 2 (18.75) 4.0 2.00 + 1.00 2.0 "As seen in the results to date, CLR 131 has demonstrated an outstanding safety profile in heavily pretreated, relapsed or re
Slide 21: CLR 131: Multiple Myeloma Market Overview
21 CLR 131: Multiple Myeloma Market Overview • Unmet Need Remains in The Relapsed or Refractory (R/R) Setting • Annual U.S.: 2 nd Most Common Hematologic Cancer 1 – Prevalence ~ 90,000 – Incidence ~ 30,330 – Relapsed/Refractory ~ 13,000 • MM Drug Market – $8.9B (2014) - $22.4B (2023) – CAGR 11.2% 2
Slide 22: CLR 131: Phase II Study in Relapse Refractory B-cell Malignancies
22 CLR 131: Phase II Study in Relapse Refractory B - cell Malignancies ~120 Patients Screened Optional 20 - 30 DLBCL 5 20 - 30 Mantle Cell lymphoma 20 - 30 CLL 1 /SLL 2 , MZL 3 , LPL 4 20 - 30 Multiple Myeloma Efficacy Assessments Primary End Point: Overall Response Rate Follow - up (min 1 year post
Slide 23: CLR 131: HemOnc Market Opportunity
23 • Multiple Myeloma • Diffuse Large B Cell Lymphoma • Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma • Marginal Zone Lymphoma and Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma MM Line Extension • Dose & Regimen • Combination Therapy • ASCT Conditioning Relapsed/Refractory $850+ Milli
Slide 24: PDC Chemotherapeutic Program Overview
24 PDC Chemotherapeutic Program Overview • Objective – Develop chemotherapeutic PDCs with improved efficacy & tolerability • Clinical Rationale – Chemotherapeutics highly effective, yet highly toxic drugs – Combining the unique targeting capabilities of PDCs with cytotoxic drugs improves therapeutic
Slide 25: Pierre Fabre PDC Collaboration
25 Pierre Fabre PDC Collaboration • Announced December 2015 – Launched Q1 2016 • Pierre Fabre Provides Selection of Proprietary Cytotoxins • Objectives – Co - design library of PDCs • Lead product conjugation completed – Conduct in vitro assessments – Conduct in vivo POC studies • Targeting/biodistr
Slide 26: Financial Summary
26 Financial Summary Capitalization as of September 30, 2016 Common Stock Outstanding 5,368,235 Warrants (Exercise prices ranging from $2.13 to $250.00) Stock Options 4,629,842 488,142 Fully Diluted Securities Outstanding 10,486,219 Cash Position $5,645,968 Cost Efficient, Targeted Investment Extend
Slide 27: Company Developments
27 Company Developments Q3 - Q4 2015 Q1 - Q2 2016 Q3 - Q4 2016 PDC Delivery Platform Introduced - Q3 - Therapeutic Focus - CTX Program - Collaboration Model Pierre Fabre - Q1 - PDC Collaboration Initiated CLR 131 $2M NCI Fast Track Award - Q3 - Contract Granted - Phase II Clinical Study in Hematolog
Slide 28: Company Developments: 2017 Clinical Events
28 Company Developments: 2017 Clinical Events Q1 2017 Q2 2017 Q3 2017 Q4 2017 CLR 131 Phase I Clinical Study, Cohort 3: • (25 mCi) Fully Enrolled • Initial Data Release • Updated Data Release CLR 131 Phase II Clinical Study: • Initiation • First Patient Enrolled Pierre Fabre Collaboration Update CLR
Slide 29: Company Leadership
29 Company Leadership Management Jim Caruso President, CEO and Director HIP Innovation Technology - EVP & COO; Allos Therapeutics - EVP & CCO; BCI, Novartis, BASF, BMS Chad Kolean CFO Pioneer Surgical Technology - CFO; TomoTherapy - Corporate Controller Jarrod Longcor SVP Corporate Development and O