Cellectar Biosciences, Inc. · NASDAQ:CLRB
Cellectar Biosciences — Investor Presentation (December 2020)
31 slides from Cellectar Biosciences's investor presentation, Dec 23, 2020
Slide 1: Corporate Presentation December 2020
Corporate Presentation December 2020 NASDAQ: CLRB
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: Presentation Topics
Company Summary and Next Steps Company Overview 1 3 CLR 131 Clinical Development & Approval Pathway 2 Presentation Topics 4 Financials 3
Slide 4: Company Overview
Developing oncology therapies in rare adult and pediatric orphan and ultra orphan indications 4 Advancing Phase 1 pediatric study in malignant brain tumors, neuroblastoma, and sarcomas Initiated Waldenstrom’s macroglobulinemia ( WM) pivotal study in Q4 2020; first patient planned enrollment January
Slide 5: CLR 131 Franchise Strategic Construction: Multiple Pathways to Value Creation
CLR 131 Franchise Strategic Construction Multiple Pathways to Value Creation CLR 131 Maintains Multiple Clinical Development Pathways; Active Radiotherapeutic Partnership Market Provides Strategic Options 5 Clear Registration Pathway in Waldenstrom’s macroglobulinemia; Enriching Triple Class Refract
Slide 6: First to Market Indication: Waldenstrom's macroglobulinemia
CLR 131 First to Market Indication Waldenstrom’s macroglobulinemia • Excellent efficacy and safety profile; extended Treatment Free Survival (TFS) • 1 WM approved drug & shifting treatment dynamics favor CLR 131 • Ultra - orphan status and CLR 131 Fast Track Designation accelerates registration path
Slide 7: Presentation Topics: CLR 131
Company Summary and Next Steps Company Overview 1 7 CLR 131 Clinical Development & Approval Pathway 2 Presentation Topics 4 Financials 3
Slide 8: CLR 131 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 9: Waldenstrom's Bridges Between NHL & MM: FGFR3 and Lipid Rafts
Waldenstrom’s macroglobulinemia Bridges Between NHL 3 & MM FGFR3 Overexpression in B - cell Malignancies and Lipid Rafts • High level of tyrosine kinase receptors (TKR) = High presence of lipid rafts • FGFR3 (a TKR) is over expressed in hematologic malignancies ‒ 100% WM • Images A & B demonstrate a
Slide 10: Waldenstrom's macroglobulinemia Disease Overview
Waldenstrom’s macroglobulinemia Disease Overview An Incurable Form of non - Hodgkin’s Lymphoma • Ultra - rare orphan disease • Incurable disease with significant sequelae 4 – Hyperviscosity syndrome – Cyroglobulinemia/skin lesions – Cold agglutinemia – IgM induced peripheral neuropathy – Anemia/redu
Slide 11: Waldenstrom's Patient Journey
Waldenstrom’s macroglobulinemia Patient Journey No Post - ibrutinib Approved Therapies Patient experiences symptoms Patient visits primary care doctor Testing occurs Diagnosis Patient transferred to specialty academic/oncology medical center Treatment given Retreatments First - line treatments: • Ri
Slide 12: WM Risk Profile Impact on Disease Progression
WM Risk Profile Impact on Disease Progression CLR 131 Has Demonstrated Activity in All Risk Profiles and Genotypes Risk Group Median Time to Progression High Risk 1.9 years Intermediate Risk 4.8 years Low Risk 9.3 years MYD88 Status Median Time to Progression Wild type 1.3 years Mutated 5.1 years Fo
Slide 13: Waldenstrom's Unmet Patient Need
Waldenstrom’s macroglobulinemia Unmet Patient Need Clear Clinical and Market Opportunity for CLR 131 BTKi poor efficacy in key genotypes • MYD88 WT /CXCR4 WT : No major responses • MYD88 WT /CXCR4 Mut : 70% progress within 2 years • MYD88 Mut /CXCR4 Mut : Greater major response rates, no complete re
Slide 14: CLR 131 WM Global Pivotal Study Design
CLR 131 WM Global Pivotal Study Design Open Label, Single Arm Registration Clinical Study; Rolling Submission CLR 131 Major Response Rate of 20% Achieves Statistical Significance Primary Endpoint Assessment (Major Response Rate) Secondary Endpoint Assessments (Duration of Response, Overall Response
Slide 15: Waldenstrom's Disease Assessment: Serum IgM Biomarker
Waldenstrom’s macroglobulinemia Disease Assessment Serum IgM is Primary Biomarker for Response Rate No decrease or increase from baseline Up to 25% reduction 25% - 50% reduction 50% - 90% reduction > 90% reduction Decreasing Serum IgM Levels and Clinical Symptoms/Extramedullary Disease Progressive D
Slide 16: CLR 131 Responses in BTKi Sub-optimal Response or Failed Patients
-100 -90 -80 -70 -60 -50 -40 -30 -20 -10 0 CLR 131 Responses in BTKi Sub - optimal Response or Failed Patients Single Best IgM Reduction (%) Patient’s efficacy assessment ongoing • 83% MRR in BTKi sub - optimal response or failed patients • First & only monotherapy to achieve a CR in BTKi failed pat
Slide 17: CLR 131 Treatment Free Survival in WM BTKi Failed Patients
0 200 400 600 800 1000 1200 Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 6 Days Treatment Free Survival – Ongoing For All 6 Patients Second cycle dose Initial response Major response Complete response 830 513 394 171 49 19 TFS ongoing Stable disease • Initial response for most patients
Slide 18: WM Major Response Rates: CLR 131 Exceeds All Reported MRRs
WM Major Response Rates CLR 131 Exceeds All Reported MRRs (Overall and by Subtype) Drug Overall Prior BTKi exposure MYD88 MUT / CXCR4 WT MYD88 MUT / CXCR4 MUT MYD88 WT / CXCR4 MUT MYD88 WT / CXCR4 WT Ibrutinib (n=63) 78% N/A 91.2% 61.9% NR 0% Acalabrutinib (n=92) 78% NT NR NR NR NR Zanubrutinib (n=7
Slide 19: Waldenstrom's Global Market Epidemiology and Treatment Centers
Waldenstrom’s macroglobulinemia Global Market Epidemiology and Treatment Centers by Region • Median age at diagnosis is 65 • 5 - year survival for high - risk patients @ 36% • U.S. represents a slightly larger market opportunity with a higher prevalence • More common in males of European descent • G
Slide 20: CLR 131 Forecasted Revenue in 2nd & 3rd Line
Waldenstrom’s macroglobulinemia Global Market CLR 131 Forecasted Revenue in 2 nd & 3 rd Line Patient Population Assumptions Factor 2 nd /3 rd Line Population 6,008 Annual Growth Rate 2.33% Revenue Per Dose $75,000 Avg. Revenue Per Patient $262,500 Market Ramp to Peak Penetration 6 Years • Global WM
Slide 21: CLR 131 for Multiple Myeloma: Patient Population Characteristics
Criteria Total Body Dose <50 mCi ( n=11) Total Body Dose ~50 mCi ( n=22) Total Body Dose ≥ 60 mCi (n=20) Total (n=53) Median Age (Min - Max) 68.5 (55 - 85) 70 (51 - 82) 70 (59 - 83) 70 (51 - 85) Male (%) 50 60 71 62 Median Prior Lines of Therapy (Min - Max) 4 (3 - 12) 5 (2 - 13) 5 (3 - 17) 5 (2 - 17
Slide 22: Multiple Myeloma Competitive Landscape
47.1% n=17 40.0% n=15 n=17 53.8% n=13 ORR for On - Market Drugs 0 10 20 30 40 50 Percent of Patients All Patients ORRs On - Market Drugs 18 • ORR for on - market drugs 22.9% to 31% • Only two approved drugs with triple class refractory response data ‒ Selinexor (25.4%) and belantamab (31%) Multiple
Slide 23: Well Tolerated Safety Profile in WM, MM and Other NHLs
CLR 131 All B - cell Malignancies Patients Well Tolerated Safety Profile in WM, MM and Other NHL’s Treatment Emergent Adverse Events 14 ( ≥25% of All Patients) Preferred Term ALL DOSES Total n = 88 Phase 1 & 2 Pts Overall n (%) ≥ Grade 3 n (%) Thrombocytopenia 73 (83) 64 (73) Lymphocyte count decrea
Slide 24: Presentation Topics: Financials
Company Summary and Next Steps Company Overview 1 24 CLR 131 Clinical Development & Approval Pathway 2 Presentation Topics 4 Financials 3
Slide 25: Financials: Capitalization as of November 9, 2020
Financials 25 Capitalization as of November 9, 2020 Common Stock Outstanding 26,813,593 Reserved for issuance: Convertible Preferred Stock 20 537,500 Warrants 17,937,766 Employee/Director Stock Options 1,184,464 Fully Diluted 46,473,323 Cash/Equivalents as of September 30 ~$18.8 million WM Pivotal S
Slide 26: Presentation Topics: Next Steps
Company Summary and Next Steps Company Overview 1 CLR 131 Clinical Development & Approval Pathway 2 Presentation Topics 4 Financials 3 26
Slide 27: Company Summary, CLR 131 Clinical Development and Next Steps
• High unmet medical need and significant market opportunity in Waldenstrom’s macroglobulinemia and Multiple Myeloma ‒ WM: BTKi (ibrutinib) failed patients ‒ MM: Subset populations: Later line, triple class & quad/penta refractory • CLR 131 impressive product profile in B - cell malignancies ‒ WM: 1
Slide 28: Thank You
Thank You Vv @, CELLECTAR BIOSCIENCES
Slide 29: Footnotes
Footnotes 1. Mechanism of Action 2. Overall Response Rate 3. Non - Hodgkin’s Lymphoma 4. https://www.iwmf.com/about - wm/signs - and - symptoms 5. Sekhar J, et.al.. Waldenström macroglobulinemia: a SEER database review from 1988 to 2005. Leuk Lymphoma 2012;53(8):1625 - 1626 ; 6. https://www.orpha.ne
Slide 30: 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 31: Waldenstrom's Disease Manifestation: MYD88 and CXCR4 Genotypes
Waldenstrom’s macroglobulinemia Disease Manifestation MYD88 and CXCR4 Genotypes Drive Disease and Outcomes 30 - 40% have CXCR4 mutation 9 >90% have mutation in MYD88 8 Increased Survival, Proliferation, Migration of Cancer Cells TLR 4 TLR 4 IL 1 R IL 1 R CXCR 4 CXCR 4 MYD88 MYD88 BTK MYD88 Mut BTK B
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