Slide 1: Corporate Presentation May 2020
Corporate Presentation May 2020 NASDAQ: CLRB Issuer Free Writing Prospectus Filed Pursuant to SEC Rule 433 Registration Statement No. 333 - 238132 May 20, 2020
Slide 2: Offering Summary
Issuer Cellectar Biosciences Symbol / Exchange CLRB / NASDAQ CM Type of Offering S - 1 Securities Offered Common Stock and Warrants Offering Size $17.5 Million Use of Proceeds Research and development and general corporate purposes Sole Bookrunner Oppenheimer & Co. 2 Offering Summary
Slide 3: Forward-Looking Statements
Forward - Looking Statements 3 This presentation contains forward - looking statements . Such statements are valid only as of today and we disclaim any obligation to update this information . Such statements are valid only as of today and we disclaim any obligation to update this information . These
Slide 4: Statement about Free Writing Prospectus
Statement about Free Writing Prospectus 4 • This presentation highlights basic information about us and the offering . Because it is a summary that has been prepared solely for informational purposes, it does not contain all of the information that you should consider before investing in our company
Slide 5: Presentation Topics
Company Summary Company Overview 1 5 CLR 131 Registration Path for Hematologic Malignancies 2 Presentation Topics Establishing CLR 131 in Pediatric Malignancies 3 4
Slide 6: Company Overview
Financing secures pivotal study top line data due to efficient capital allocation and low fixed - cost structure Developing oncology therapies for high unmet medical need in rare adult and pediatric orphan indications 6 Multiple preclinical programs ready for IND enabling studies Ongoing Phase 1 ped
Slide 7: Strategic Construction of CLR Franchise
Strategic Construction of CLR 131 Franchise Multiple Pathways to Value Creation Large Pharma Recognition of Targeted Radio - therapeutic Potential; Multiple Recent Acquisitions and Partnerships 100% ORR 2 to date in r/r LPL/WM 3 Only drug to achieve monotherapy complete response 42.8% ORR in r/r MM
Slide 8: Company Milestones
Company Milestones 2H 2019 Objectives 2020 Objectives 2020 Objectives Completed Phase 1 MM & Initiated Phase 1 Pediatric Study Provide Phase 1 Data 1Q: r/r MM Formal FDA Guidance “Type B” Meeting 3Q: Pivotal Study Design Provided Phase 2 Data Update: B - cell Malignancies Provide Phase 2 Data 1Q: B
Slide 9: CLR - A Phospholipid Ether Radio-conjugate
CLR 131 - A Phospholipid Ether (PLE) Radio - conjugate Combination of a Validated Delivery Platform and Therapeutic Payload • Tumor cells utilize lipids at significantly greater quantities than normal tissue – Energy source ( b - oxidation) – Cell membrane production – Signaling molecules • Cellecta
Slide 10: FGFR3 Overexpression in B-cell Malignancies and Lipid Rafts
CLR 131 - A Phospholipid Ether Radio - conjugate FGFR3 Overexpression in B - cell Malignancies and Lipid Rafts • High level of tyrosine kinase receptors (TKR) = High presence of lipid rafts ‒ In MM, LPL/WM and NHL the TKR of interest is FGFR3 • FGFR3 over - expression in ~50% of MM and 100% LPL/WM p
Slide 11: Presentation Topics
Company Summary Company Overview 1 11 CLR 131 Registration Path for Hematologic Malignancies 2 Presentation Topics Establishing CLR 131 in Pediatric Malignancies 3 4
Slide 12: CLR 131 Phase 2 Study Design
• <50mCi Total Body Dose Single Dose • 50mCi Total Body Dose Single Cycle • 75mCi Total Body Dose Single Cycle CLR 131 Phase 2 Study Design Phase 2b Initiated; Heading to Pivotal 12 CLL/SLL, MZL, LPL/WM DLBCL MM Potential Expansion to Pivotal Futility Efficacy Assessments Interim efficacy assessment
Slide 13: CLR 131 r/r Multiple Myeloma Patient Characteristics
Criteria Total Body Dose <50mCi ( n=10) Total Body Dose 50mCi ( n=20) Total Body Dose 75mCi (n=17) Total (n=47) Median Age (Min - Max) 68.5 (55 - 85) 70 (51 - 82) 70 (59 - 83) 70 (51 - 85) Male (%) 50 60 71 62 Median ECOG PS 8 1 1 0.5 1 Median Prior Therapies (Min - Max) 4 (3 - 12) 5 (2 - 13) 5 (3 -
Slide 14: Phase 2 Achieves Primary Efficacy Endpoint (ORR)
• 100% of patients across all doses achieved a minimum of stable disease • 85.7% of patients experienced tumor reduction • 34.5% Combined ORR for 50mCi and 75mCi TBD 14 n=19 n=14 0% 10% 20% 30% 40% 50% 0% 10% 20% 30% 40% 50% Third Line Fourth Line Fifth Line 8% CLR 131 r/r Multiple Myeloma Phase 2 A
Slide 15: Efficacy in Challenging Patient Subtypes
0% 10% 20% 30% 40% 50% 60% <50 mCiTBD ~50 mCi TBD ~75 mCi TBD ORR In High Risk Patients (n=14) <50mCi TBD 50mCi TBD 75mCi TBD CLR 131 r/r Multiple Myeloma Efficacy in Challenging Patient Subtypes • CLR 131 demonstrates dose response in high risk patients – 25% achieve PR or better 50mCi TBD – 50% ac
Slide 16: r/r Multiple Myeloma Competitive Landscape
CLR 131 r/r Multiple Myeloma Competitive Landscape Approved Products and Late Stage Development Programs Approved Overall Response Rate (ORR) - % Triple Class Refractory ORR - % Progression Free Survival (PFS) - Months Selinexor 15 25.4 25.4 3.7 Daratumumab 16 29.2 refractory 3.7 Pomalidomide 17 29.
Slide 17: Progression Free Survival and Duration of Response
CLR 131 r/r Multiple Myeloma Progression Free Survival (PFS) and Duration of Response (DOR) • CLOVER - 1 Study Median PFS and DOR not yet reached • Median PFS predicted to be 4.7 (50mCi) and 5.5 (75mCi) and >9 months (100mCi) • DOR at > 6 months: 52% at 75mCis and 100% of patients at 100mCis 17 100m
Slide 18: Two Cycle Dosing Optimization Pharmacokinetics
1000 10000 100000 1000000 10000000 100000000 CLR 131 (Median dpm/mL) Time (Days) <50 mCi TBD ~50 mCi TBD ~75 mCi TBD ~100 mCi TBD CLR 131 Two Cycle Dosing Optimization Pharmacokinetics - ~200% Increase of Area Under the Curve • Radiotherapeutic efficacy is driven by absorption/exposure to radiation
Slide 19: Well Tolerated Safety Profile
CLR 131 All r/r B - cell Malignancies Patients Well Tolerated Safety Profile Treatment Emergent Adverse Events 22 ( > 25% of All Patients) Preferred Term <50mCi Total Body Dose n = 11 50mCi Total Body Dose n = 31 75mCi Total Body Dose n = 24 ALL DOSES Total n = 66 Phase 1 & 2 Pts Overall n (%) > Gra
Slide 20: CLR 131 r/r MM Pivotal Study
Proposed Pivotal Study Design Program Timing 24 Clinical Costs 24 • Expand ongoing 2 cycle arm by 40 - 50 additional patients (total n= 65 - 85) • Triple class refractory patients • Primary endpoint: ORR • Key Secondary endpoints: PFS and DOR • Phase 2b expansion 1Q2020 • Type B meeting 2H2020 • Com
Slide 21: r/r Non-Hodgkin's Lymphoma Patient Characteristics
CLR 131 r/r Non - Hodgkin’s Lymphoma 27 Challenging Patient Population - Characteristics 28 Total Body Dose 50mCi ( n=12) Total Body Dose 75mCi ( n=7) Total (n=19) Median Age (Min - Max) 70 (52 - 79) 72 (65 - 86) 70 (52 - 86) Male (%) 47.5 71 55 Median ECOG PS 29 1 1 1 Median Prior Therapies (Min -
Slide 22: r/r NHL Efficacy in Heavily Pretreated Patients
0% 5% 10% 15% 20% 25% 30% 35% 40% 45% Phase 2 Response Rates 30 ORR 32 CR 32 ORR ORR CR CR CLR 131 r/r Non - Hodgkin’s Lymphoma Efficacy in Heavily Pretreated Patients • Diverse, advanced and heavily pretreated patient population – Multiple r/r B - cell lymphoma histologies: DLBCL, transformed DLBCL
Slide 23: r/r B-cell Malignancies Efficacy by Key Sub-indications
Overall Response Rate Complete Response Rate Major Response Rate MM (n=14) 42.8% --- N/A LPL/WM (n=4) 100% 25% 75% DLBCL (n=10) 30% 10% 30% LPL/WM 100% 25% 75% • CLR 131 demonstrates activity in both aggressive and indolent NHL disease • 75% of LPL/WM treated patients were refractory to rituximab or
Slide 24: r/r LPL/WM Competitive Landscape
r/r LPL/WM Competitive Landscape 2nd Line or Later Monotherapy - 1 Approved Product 24 Approved Overall Response Rate (ORR) Major Response Rate Complete Response Rate Ibrutinib 34 (n=63) 90.5% 61.9% 0% Development Venetoclax (n=20) 86% 60% 0% CLR 131 100% 75% 25% • Rituximab combinations are first l
Slide 25: CLR r/r LPL/WM Pivotal Study
25 CLR 131 r/r LPL/WM Pivotal Study Accelerated Study Design in Non - responsive and Intolerant ibrutinib Patients Proposed Pivotal Study Design • Expand ongoing 2 cycle arm by 15 - 20 additional patients (total n=15 - 25) • Ibrutinib non - responsive and intolerant patients • Primary endpoint: ORR
Slide 26: Presentation Topics
Company Summary Company Overview 1 26 CLR 131 Registration Path for Hematologic Malignancies 2 Presentation Topics Establishing CLR 131 in Pediatric Malignancies 3 4
Slide 27: CLR 131 Pediatric Clinical Development Strategy
Level 1 15mCi/m 2 Level 2 30mCi/m 2 Level 3 45mCi/m 2 Add’l levels +15mCi/m 2 Proposed Development 35 Program Timing 24 Clinical Costs • Granted U.S. ODD & RPDD 36 for NB, RMS, Osteo & Ewing’s Sarcoma • Eligible for Fast Track, Breakthrough, Accelerated Approval and Priority Review in U.S.; PRIME an
Slide 28: CLR & MIBG Product Profile Comparison
CLR 131 & MIBG Product Profile Comparison Profile CLR 131 MIBG I - 131 37 Delivery Vehicle/Payload Phospholipid Ether (PLE)/ Iodine - 131 Meta - iodobenzylguanidine/ Iodine - 131 Therapeutic Regimen TBD 3 - 5 cycles, ~300mCi per cycle, Total dose ~1000 - 1500 mC i Percent Absorbed Dose 0.84Gy/MBq (~
Slide 29: Presentation Topics
Company Summary Company Overview 1 29 CLR 131 Registration Path for Hematologic Malignancies 2 Presentation Topics Establishing CLR 131 in Pediatric Malignancies 3 4
Slide 30: Financial Summary
Financial Summary Capitalization as of March 31, 2020 Common Stock Outstanding 9,396,015 Reserved for issuance: Convertible Preferred Stock 537,500 Warrants 9,268,352 Employee Stock Options 901,214 Fully Diluted 20,103,081 Cash/Equivalents as of March 31 ~$7.1 million 30 Cash Available to Fund Opera
Slide 31: Company Summary and Near-term Opportunities
• High unmet medical need remains in r/r MM and r/r LPL/WM ‒ Significant market opportunity in triple class refractory MM patients and in ibrutinib non - responsive & intolerant LPL/WM patients • CLR 131 r/r MM and r/r LPL/WM product profile impressive ‒ MM: 42.8% ORR at 75mCi, 50% high risk, 33% in
Slide 32: Executive Leadership
Jim Caruso President, CEO and Director HIP Innovation Technology - Co - Founder, EVP & COO, Allos Therapeutics - EVP & CCO, BCI, Novartis, BASF, Bristol - Myers Squibb Dov Elefant Chief Financial Officer Akari Therapeutics PLC - CFO, Celsus Therapeutics, Inc. - CFO Lev Pharmaceuticals - Corporate Co
Slide 33: Thank You
Thank You WZ @ CELLECTAR BIOSCIENCES
Slide 34: Footnotes
Footnotes 1. Mechanism of Action 2. Overall Response Rate 3. Lymphoplasmacytic Lymphoma/Waldenstrom’s Macroglobulinemia 4. Multiple Myeloma 5. Diffuse Large B - cell Lymphoma 6. European Union 6 Non - Hodgkin’s Lymphoma 7. Data as of 31Jan2020 8. Eastern Cooperative Oncology Group Performance Status