Cellectar Biosciences, Inc. · NASDAQ:CLRB
Cellectar Biosciences — Investor Presentation (March 2022)
24 slides from Cellectar Biosciences's investor presentation, Mar 15, 2022
Slide 1: Corporate Presentation March 2022
Corporate Presentation March 2022 N A S D A Q : C L RB
Slide 2: Forward-Looking Statements
Forward - Looking Statements 2 This 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: Company Highlights
Developing iopofosine I - 131 (formerly known as CLR 131), a small - molecule radiotherapeutic in rare adult and pediatric cancer indications Additional clinical studies ongoing, including a Phase 2b study in highly refractory multiple myeloma; potential for near - term commercialization and route t
Slide 4: PDC Platform Technology
PDC Platform Technology Phospholipid Ether (PLE) PLE Cancer - Targeting Vehicle 4 Linker Versatile Chemistry Drug Payload PDC Cancer Targeted Payload
Slide 5: Targeted Delivery to Tumor Cells
Targeted Delivery to Tumor Cells PDC with Cancer targeted payload Specific Targeting of Cancer Intracellular Delivery to Cancerous Cells Selective Release of Payload inside Cell 1 2 3 4 5
Slide 6: PDC Strategy
PDC Strategy Phospholipid Ether Franchises - Value Creation Through Intracellular Delivery Peptide and Nanobody Drug Conjugates Small Molecule Drug Conjugates Radio - conjugates Radio - conjugate Franchise • Ability to provide targeted delivery of any radioisotope • Currently developing alpha & beta
Slide 7: Pipeline
7 Pipeline Additional Value Creation Through Innovative Partnering Approach and Platform Utility P D C P r o g ram Indication Discovery Preclinical Phase 1 Phase 2 Pivotal Collaboration Partner Iopofosi n e I - 131 Waldenstrom’s macroglobulinemia Hig h l y Refr ac tory Multiple Myeloma Pediatric Hea
Slide 8: Iopofosine I-131: Our Lead Product Candidate
Iopofosine I - 131: Our Lead Product Candidate Pivotal Study in Waldenstrom’s macroglobulinemia Phase 2 CLOVER - 1 study in highly refractory MM Phase 1 CLOVER - 2 study in relapsed pediatric cancers (high grade glioma & soft tissue sarcomas) A small - molecule PDC designed to provide targeted deliv
Slide 9: Waldenstrom's Macroglobulinemia
Waldenstrom’s Macroglobulinemia • The bone marrow produces too many abnormal white blood cells crowding out healthy blood cells • The abnormal white blood cells produce a protein (IgM) that accumulates in the blood, impairs circulation and causes complications • It is slow growing. Typical signs & s
Slide 10: WM Second Line Current Standard of Care
10 WM Second Line Current Standard of Care Only 1 class (BTKi’s) of approved drugs in WM (ibrutinib and zanubrutinib) No monotherapy demonstrating major responses in dual WT patients (MYD88 & CXCR4 representing 20 - 40% of patients) Limited switching between ibrutinib and zanubrutinib Prior to first
Slide 11: Iopofosine I-131 Response Rates in WM
Iopofosine I - 131 Response Rates in WM • Only treatment tested in BTKi failure patients • Effective across all genotypes 7 • 100% of high - risk patients achieved an MRR; including one Complete Response • Deep and durable responses achieved in challenging relapsed or refractory patients o Total ave
Slide 12: Iopofosine Safety Profile
Iopofosine Safety Profile: Well - Tolerated in WM, MM and other NHLs Predictable and Manageable AE - profile / Predictable Time to AE - Resolution Treatment Emergent Adverse Events 7 (≥25% of All Patients) A ll Dos e s T o ta l n =88 Phase 1 & 2 Pts Preferred Term Overall n ( % ) ≥ Grade 3 n ( % ) T
Slide 13: Global WM Pivotal Study Design
Single Arm Open - label Registration Study Enrolling; Fast Track Designation Iopofosine I - 131: Global WM Pivotal Study Design FDA Agreed Upon Pathway to Approval Primary Endpoint : Major Response Rate (MRR) of 20% (10 of 50 Patients) Achieves Statistical Significance 12 MONTHS Primary Endpoint: Ma
Slide 14: Waldenstrom's Macroglobulinemia Disease Assessment
Waldenstrom’s Macroglobulinemia Disease Assessment Serum IgM is Primary Biomarker for Response Rate P r ogr es si ve Disease (PD) Stable D ise a se (SD) Minor R es pon se (MR) Partial R es pon se (PR) Complete R es pon se (CR) Decreasing Serum IgM Levels and Clinical Symptoms/Extramedullary Disease
Slide 15: WM Pivotal Study Expected Milestones
WM Pivotal Study Expected Milestones Q1 2022 Q2 2022 2H 2022 15 Safety & Futility Analysis Continued E n r ol l ment Top - line Data U.S. Breakthrough and EU Prime Designation Submissions Planned for 2022
Slide 16: Iopofosine I-131 in Multiple Myeloma
Iopofosine I - 131 in Multiple Myeloma Demonstrates Profound Activity in Late Line Difficult to Treat MM Patients Enrichment of Highly Refractory MM Patient Data Provides Strategic Route to NCCN Guideline Inclusion and Potential Third - party Reimbursement 0. 0 % 1 0.0% 2 0.0% 3 0 .0% 4 0.0% 5 0.0%
Slide 17: Iopofosine I-131 in r/r Multiple Myeloma
Iopofosine I - 131 r/r Multiple Myeloma Triple Class and Penta - drug Refractory Iopofosine I - 131 Demonstrates Strong Activity in Triple Class Refractory MM Percent Reduction by Best Response Best Response in Refractory Patients 40% 20% 0% - 2 0% - 4 0% Respons e - 8 0% Triple Class Refractory Tri
Slide 18: Phase 2 CLOVER-1 Study in B-cell Lymphomas
• Median age = 70 • Median third line patients • Highly refractory DLBCL, CLL/SLL, MZL and MCL – ~60 % of patients were multi - drug refractory Iopofosine I - 131 Phase 2 CLOVER - 1 Study in B - cell Lymphomas Non - Hodgkin’s Lymphoma 43 % ORR i n N H L 71.4% Clinical Benefit Rate Median tumor volum
Slide 19: Iopofosine I-131 in Pediatric Phase Global Study
Iopofosine I - 131 in Pediatric Phase 1 Global Study – Accelerated Development Approach Primary objective • Part A to determine the safety, tolerability, and initial efficacy of iopofosine I - 131 in children with relapsed/refractory malignancies (ongoing) • Part B efficacy confirmation and potentia
Slide 20: Financial Summary
Financial Summary 20 Cash position as of December 31 , 2021 (millions) $ 35.7 M Cash anticipated to support strategic plan into Q3 2023 Capitalization as of November 8, 2021 Common Stock Outstanding 61,101,26 3 Reserved for issuance: Convertible Preferred Stock 1,111,111 Warrants 15,633,825 Employee
Slide 21: Company Summary
Developing iopofosine I - 131, a small - molecule radiotherapeutic in rare adult and pediatric hematologic and solid tumor indications Efficacy demonstrated in multiple r/r cancer types including highly refractory MM - 47% ORR in hexa - line, 40% triple class and 54% quad/penta refractory Anticipate
Slide 22: Experienced Management
r Experienced Management James Caruso President, CEO and Director Chad Kolean Chief Financial Officer Laurence Reilly, MD, LL.M Interim Chief Medical Officer Jarrod Longcor Chief Business Officer 22
Slide 23: Thank You
CELLECTAR BIOSCIENCES THANK YOU NASDAQ: CLRB
Slide 24: Footnotes
25 F o o tn o t es 1. Datamonitor Healthcare; Centers for Disease Control and Prevention, 2017; Ferlay et al., 2018; National Cancer Institute, 2017; Steingrímsson et al., 2017; United Nations, 2017 Non - Hodgkin’s Lymphoma www.iwmf.com/about - wm/signs - and - symptoms October 2021 IWMF Torch: Newt
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