SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report: September 6, 2018
(Date of earliest event reported)
CELLECTAR BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
3301 Agriculture Drive, Madison, Wisconsin
(Address of principal executive offices)
(Registrant's telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
|¨||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|¨||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|¨||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|¨||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
|ITEM 7.01||REGULATION FD DISCLOSURE|
On August 29, 2018, we issued a press release announcing that James Caruso, our President and Chief Executive Officer, will be presenting at the 20th Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., on Thursday, September 6 at 5:30 p.m. Eastern time.. A copy of the Corporate Presentation to be used is furnished as Exhibits 99.1, and is incorporated by reference herein.
|ITEM 9.01||FINANCIAL STATEMENTS AND EXHIBITS|
|99.1||Cellectar Biosciences, Inc. September 2018 Corporate Presentation|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Dated: September 6, 2018||CELLECTAR BIOSCIENCES, INC.|
|By:||/s/ Brian M. Posner|
|Name:||Brian M. Posner|
|Title:||Chief Financial Officer|
Corporate Presentation September 2018 NASDAQ: CLRB
Forward - Looking Statements 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 uncertainties that may cause actual future experiences and results to differ materially from the statements made . These statements are based on our current beliefs and expectations as to such future outcomes . Drug discovery and development involve a high degree of risk . Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital required to complete the development programs described herein, uncertainties related to the disruptions at our sole supplier of CLR 131 , the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, the ability of our pharmaceutical collaborators to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third - party reimbursement . This presentation includes industry and market data that we obtained from industry publications and journals, third-party studies and surveys, internal company studies and surveys, and other publicly available information . Industry publications and surveys generally state that the information contained therein has been obtained from sources believed to be reliable . Although we believe the industry and market data to be reliable as of the date of this presentation, this information could prove to be inaccurate . Industry and market data could be wrong because of the method by which sources obtained their data and because information cannot always be verified with complete certainty due to the limits on the availability and reliability of raw data, the voluntary nature of the data gathering process and other limitations and uncertainties . In addition, we do not know all of the assumptions that were used in preparing the forecasts from the sources relied upon or cited herein . A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10 - K for the year ended December 31 , 2017 and our Form 10 - Q for the quarterly period ended June 30 , 2018 . 2
Developing orphan and rare pediatric oncology pipeline with multibillion - dollar 1 sales potential 3 Efficient capital allocation and low fixed - cost corporate structure allows for ~$10M - $12M annual cash burn PDC tumor targeting platform validated through clinical trials and corporate partnerships Company Highlights 9 clinical data readouts planned through 2019 Advancing multiple clinical programs; demonstrated activity in hematologic malignancies Multiple, Value - Creative, Near Term Milestone Potential 1. ResearchAndMarkets.com's offering. Neuroblastoma - Market Insights, Epidemiology and Market Forecast - 2027 The market of Neuro blastoma in 7MM was found to be USD 733.58 million in 2016, and is expected to increase at from 2016 - 2027. Market Research Future Jan 2018 The osteosarcoma market has been on the rise over the past few ye ars. Based on the MRFR analysis, the market is projected to reach USD 136.76 million by 2023 at a healthy CAGR of around 6.40%. Market Research Future July 2018 - The global pediatric brain tumor market is expected to reach US$ 1659.4 million by 2023.
Cellectar Accomplishments in the Past 3 Years Robust Pipeline Focused on Unmet Need in Cancer 1 Mid - stage Clinical Compound 6 FDA Special Designated Programs 4 ODD 1 3 RPDD 2 9.8 Million Dollars in non - dilutive funding 6 Preclinical Phospholipid Drug Conjugate (PDC) Programs Creating the Next Generation of Targeted Cancer Therapies 5 Corporate PDC Partnerships 4 1. Orphan Drug Designation 2. Rare Pediatric Disease Designation
Pipeline Focus on Niche Oncology Indications with Accelerated Commercial Timelines to Scalable Markets PDC 1 Indications Discovery Pre - IND Phase 1 Phase 2 Payload CLR 131 Multiple Myeloma 2 Iodine - 131 B - Cell Lymphomas 2 Pediatric Cancer Head & Neck 3 CLR 1700 Hematologic Tumors BTK 4 CLR 1900 Solid Tumors Undisclosed CLR 1800 Solid Tumors CLR 2000 Performance - based CLR 2100 Solid Tumors CLR 2200 Solid Tumors CLR 12120 Solid Tumors Current Partnerships 5 1. Phospholipid Drug Conjugates 2. Phase 2 partially funded by $2M NCI Fast Track Grant 3. Predominately funded by Univer sit y of Wisconsin NCI SPORE Grant 4. Burton’s Tyrosine Kinase Leverage POC Data in Larger Opportunities to Attract Partners
CLR 131 CLR 131 1 6
7 CLR 131: Manufacturing Update • CLRB notified of FDA CPDC 1 Import Action on 8/07/18 • Import Action derived from an FDA inspection of CPDC on 3/28/18 • CLRB was not previously notified since the inspection observations were not related to CLR 131 • The product flagged is manufactured in a different building on CPDC campus • FDA scheduled to meet with CPDC in September to review remediation of the observations and evaluate removal of Import Action 1. Centre for Probe Development and Commercialization
• Radiotherapeutic Market forecast ~$9.3 billion revenue in 2020 1 – Novartis acquires Advanced Accelerator Applications for $3.9 billion 2 • Lead product Lutathera - Radioligand Therapy – Bayer’s Xofigo® radiotherapeutic generates $473M in revenue 3 – Progenics Pharma Azedra™ (MIBG I - 131) market cap of ~$600M 4 • CLR 131 Strategic Approach – Establish Phase 2 data for DLBCL 5 & MM 6 to drive potential partnerships – Advance R/R 7 niche market opportunities to commercialization • R/R B - Cell lymphomas (LPL 8 , MZL 9 , MCL 10 ) – Few approved therapies; Accelerated route to market – Potential revenues ~$800M US/~$1.8B worldwide 11 • R/R Pediatric Tumors ( NB 12 , High Grade Glioma, RMS 13 , Ewing’s & Osteosarcoma) – Approximately 40 U.S. treatment centers; ~20 MIBG I - 131 for NB – Target indications represent ~30% of pediatric oncology market 14 – Potential revenues ~$600M US/~$1.5B worldwide 15 8 Radiotherapeutic Market & CLR 131 Positioning 1. Seeking Alpha Report - Change to Research & Markets, "Global Radiotherapy Market Analysis, Companies Profiles, Size, Share, G rowth, Trends and Forecast to 2024" Feb 2017 2.2017 - https://bit.ly/2ut9KZI 3. Bayer Annual Report 2017 4. 7/17/2018 - Yahoo Finance 5. Diffuse Large B - cell Lymphoma 6. Multiple Myeloma 7. Relapsed Refra ctory 8. Lymphoplasmacytic Lymphoma 9. Marginal Zone Lymphoma 10. Mantle Cell Lymphoma 11. Company Estimates. 12. Neuroblastoma 13. Rhabdomyosarcoma 14. American Cancer Society. Cancer Facts & Figures 2016 15. Company Estimates.
Program 2018 2019 2020 2021 1H 2H 1H 2H 1H 2H 1H CLR 131 Multiple Myeloma CLR 131 B - Cell Lymphoma CLR 131 Head & Neck CLR 131 Pediatric Phase 1b Fractionated Dose Readout Initiate Phase 2 (DLBCL) Phase 3 MZL Phase 2 (DLBCL) 2 Initiate Phase 1 Initiate Phase 1 Initiate Phase 2 Phase 3 Interim Assessment Pivotal Interim Assessment Phase 1 mOS 1 1. Median Overall Survival 2. Topline Data 3. Chronic Lymphocytic Leukemia 4 . Small Lymphocytic Leukemia ODD Neuroblastoma ODD Rhabdomyosarcoma RPDD Neuroblastoma RPDD Rhabdomyosarcoma 9 CLR 131: Projected Key Development Milestones Initiate Phase 2/3 Phase 1 Readout Initiate Phase 2/3 Pivotal Phase 2 Final Readout Phase 1 Readout Phase 1b Fractionated Dose Readout Study Update ODD Ewing’s Sarcoma Phase 2 ( CLL 3 /SLL 4 ) 2 DLBCL Designations Granted Initiations Data Contingent Upon Partnership Interim Data CLL/SLL Phase 2 (MZL) 2 Phase 2 (MM) 2 RPDD Ewing’s Sarcoma
Cohort 1 12.5 mCi/m 2 Cohort 2 18.75 mCi/m 2 Cohort 3 25.0 mCi/m 2 Cohort 4 31.25 mCi/m 2 Cohort 5 15.625 mCi/m 2 x 2 Metric Cohort 1 (12.5 mCi/m 2 ) Cohort 2 (18.75 mCi/m 2 ) Cohort 3 (25.0 mCi/m 2 ) Cohort 4 (31.25 mCi/m 2 ) Cohort 5 (31.25 mCi/m 2 ) Average Age 68 70 71 65 71 Prior # of Treatment Lines 5.8 4 5 5 5 Tumor Burde n 2.71 2.86 4.19 4.36 2.69 ≥ 1 Triple Combination Treatment 4/4 4/4 4/4 3/3 3/4 Stem Cell Transplant 1/4 3/4 4/4 2/3 1/4 Patient Demographics All Patients Have Advanced Disease and are Heavily Pre - treated One 30 - Minute Infusion 1. Partial Response 2. Minimal Response 3. Based on baseline B2 Microglobulin Two 30 - Minute Infusions Primary endpoints are safety, tolerability and determination of maximum tolerated dose 4 of 4 Stable Disease 4 of 4 Stable Disease 4 of 4 Stable Disease 1 of 3 PR 1 2 of 3 Stable Disease 10 CLR 131: RR MM Phase 1 Study Overview 2 of 4 MR 2 2 of 4 Stable Disease Cohort 6 18.75 mCi/m 2 x 2
TIME (MONTHS) 15.0 months SURVIVAL ONGOING 0 5 10 15 Key Results To Date 1 • All cohorts determined to be safe and well - tolerated by independent DMC 3 • No patients experiencing peripheral neuropathy, deep vein thrombosis, cardiotoxicities, embolisms or GI toxicities • Cytopenias most common adverse events – All viewed as predictable & manageable • ≥ Grade 3 fatigue and fever = 7% • No change in liver enzymes or renal function Cohort 1 (12.50) 4.75 2.05 + 0.91 2.0 Cohort 2 (18.75) 4.75 2.74 + 0.93 2.0 Cohort 3 (25.00) 6.75 2.52 + 1.22 3.0 Cohort 4 (31.25) 4.25 3.23 + 0.93 3.0 Cohort 5 (15.625 x 2) 5 2.95 + 1.10 3.0 Pooled Phase 1 study: Overall Survival (n=15) 1. Study ongoing n=19 - Final results may differ from data presented 2. Per patient 3. Data Monitoring Committee Adverse Events Avg. Number 2 Median Grade Avg. Grade 2 Survival Data last updated 02/20/18; mOS Not Reached to Date 11 CLR 131: RR MM Tolerability & Overall Survival (OS)
Patients screened N=10 DLBCL N=10 MCL N=10 CLL/SLL, MZL, LPL Follow - up (≥ 1 yr after last dose) Final efficacy assessments Interim efficacy assessments; Expand cohorts based on performance 10 - 30 CLL/SLL, MZL, LPL 10 - 30 MCL 10 - 30 DLBCL • Primary endpoint is efficacy as determined by response rate (can occur on either dose) • All cohorts currently enrolling; expect to complete study in 1H - 19 • Upon study completion, individual cohorts may advance to a pivotal trial 12 CLR 131: RR Hematologic Phase 2 Study Overview Supported with a $2M NCI SBIR Grant N=10 MM 20 - 30 MM All Patients Eligible for a Second 25.0 mCi/m 2 Dose at Day 75 - 180 Dose 1 (25.0 mCi/m 2 ) Dose 2 (25.0 mCi/m 2 ) Day 1 75 - 180 Days
CLR 131: Phase 2 DLBCL Interim Data • Diffuse Large B - cell Lymphoma (DLBCL) is an aggressive form of lymphoma, accounting for ~30% of newly diagnosed cases in the U.S. 1 • DLBCL cohort opened 1Q - 18 • 33% Overall Response Rate (ORR) to date • 50% Clinical Benefit Rate (CBR) to date • Of responses observed, overall tumor reduction ranged from 60 - 90% 13 1. According to the Lymphoma Research Foundation.
CLR 131: Phase 2 LPL Patient Case Study (Waldenstrom’s) 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000 Screen (11/2017) Day 52 (12/2017) Day 120 (3/2018) Day 186/64 (5/2018) Tumor size (mm2) Days from CLR 131 infusion Sub diaphramatic mass Left epicardial mass Aortic bifurcation Right ovary Left ovary CT scan Day 52 CT scan Day 64 CLR 131 Infusion & Baseline CT scan Second CLR 131 Infusion (123 days post 1 st dose ) & Baseline 2 nd dose CT • Baseline: Pleural effusion & multiple large tumor nodules; Symptomatic with cough • Following 1 st infusion: Dramatic improvements in cough and no significant cytopenias • CT day 64 (Post 2nd Infusion) showed 94% reduction in overall tumor burden as well as complete resolution of 4/5 tumors 1 14 Assessment Ongoing 1. Interim Data
Level 1 15 mCi/m 2 Level 2 30 mCi/m 2 Level 3 45 mCi/m 2 Add’l levels +15 mCi/m 2 n=1 n=3 n=3 n=3 Proposed Phase 2/3 Pivotal Study Design 1 Program Timin g 2 Clinical Costs 2 • Granted ODD & RPDD for NB, RMS, and Ewing’s Sarcoma • Eligible for Fast Track, Breakthrough and SPA submissions • Initial enrollment of 10 - 15 patients to confirm dose; upon appropriate efficacy expand into Phase 3 • Phase 3 pivotal trial single arm ~65 patients – Primary endpoint: Overall Response Rate – Secondary endpoints: EFS 3 , CBR 4 , PFS • Phase 1 to complete 4Q - 19 • Phase 2/3 pivotal initiation 2020 • NDA submission 2022 • Phase 1 = ~$4 million • Phase 2/3 pivotal trial = ~$15 million • Potential for SBIR grant of ~$2.3M for Phase 1 & up to $4M per indication 5 for a pivotal trial 1. Relapsed/Refractory 2. Estimated 3. Event Free Survival 4. Clinical Benefit Response Rate 5. https://www.grants.gov/web/grants/learn - grants.html Level 1 15 mCi/m 2 Level 2 30 mCi/m 2 Level 3 45 mCi/m 2 Add’l levels +15 mCi/m 2 Malignant Brain Tumors Solid Tumors/ Lymphomas 15 CLR 131: Pediatric Clinical Development Strategy FDA Agreement on Phase 1 Accelerated Study Design Approval in Any Indication May Provide Priority Review Voucher and Potential for NCCN Compendium Listing for Other Tumor Types
CLR 131 & MIBG Product Profile Comparison Profile CLR 131 MIBG - I131 Delivery Vehicle/ Payload Phospholipid Ether (PLE)/ Iodine - 131 Meta - iodobenzylguanidine/ Iodine - 131 Therapeutic Regimen Single 30 minute mCi infusion Total dose ~45 - 80 mCi 3 - 5 cycles, ~300 mCi per cycle, 90 - 120 minute infusion Total dose ~1000 - 1500 mC i Hospitalization TBD 1 4 - 8 days Capable to Cross the Blood Brain Barrier Ability to Target Metastasis Stem Cell Transplant Support NB Response Rate TBD 20 - 60% (~30%) Indicated for NB YES, u pon approval NO MIBG I - 131 currently Second Line Standard of Care for Neuroblastoma 16 FAVORABLE/POSSESSES NOT YET KNOWN DEFICIENT/LACKS 1. To Be Determined
Corporate Information 17
Financial Summary Capitalization as of September 4, 2018 Common Stock Outstanding 3,797,825 Reserved for issuance: Convertible Preferred Stock 2,142,500 Warrants 5,318,747 Employee Options 56,919 Fully Diluted 11,315,991 Cash / Equivalents as of June 30, 2018 ~$4.2 million Pro Forma Cash / Equivalents as of June 30, 2018 ~$19.1 million 1 Cash Believed to Be Adequate to Fund Operations into 2020 18 1. Company closed an underwritten public offering on July 31, 2018. Pro forma balance reflects company’s cash/equivalents bal anc e as if the underwritten public offering closed on June 30,2018.
Jim Caruso President, CEO and Director HIP Innovation Technology - EVP & COO, Allos Therapeutics - EVP & CCO, BCI, Novartis, BASF, Bristol - Myers Squibb John Friend, MD Chief Medical Officer Helsinn Therapeutics - SVP & Head of R&D, Akros Pharma, Actavis, Alpharma, Hospira, Abbott Jarrod Longcor Chief Business Officer Avillion LLP - CBO Melinta Therapeutics, Inc. (formerly Rib - X Pharmaceuticals, Inc). - VP Corp Development and Operations Brian Posner Chief Financial Officer Alliqua BioMedical , Ocean Power Technologies, Power Medical Interventions, Pharmacopeia - CFO Executive Team With ~100 Years of Healthcare Leadership and a Proven Track Record of Development and Commercialization 19 Executive Leadership
Developing orphan and rare pediatric oncology pipeline with multibillion - dollar 1 sales potential 20 Efficient capital allocation and low fixed - cost corporate structure allows for ~$10M - $12M annual cash burn PDC tumor targeting platform validated through clinical trials and corporate partnerships Company Highlights 9 clinical data readouts planned through 2019 Advancing multiple clinical programs; demonstrated activity in hematologic malignancies Multiple, Value - Creative, Near Term Milestone Potential 1. ResearchAndMarkets.com's offering. Neuroblastoma - Market Insights, Epidemiology and Market Forecast - 2027 The market of Neuro blastoma in 7MM was found to be USD 733.58 million in 2016, and is expected to increase at from 2016 - 2027. Market Research Future Jan 2018 The osteosarcoma market has been on the rise over the past few ye ars. Based on the MRFR analysis, the market is projected to reach USD 136.76 million by 2023 at a healthy CAGR of around 6.40%. Market Research Future July 2018 - The global pediatric brain tumor market is expected to reach US$ 1659.4 million by 2023.
Thank You NASDAQ: CLRB 21