Corporate
Presentation
March 2024
NASDAQ: CLRB
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Forward Looking Statements and Disclaimers
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. Factors that might cause such a material difference include our current views with respect to our business strategy, business plan and research and development activities; the progress of our product development programs, including clinical testing and the timing of commencement and results thereof; our projected operating results, including research and development expenses; our ability to continue development plans for iopofosine I 131 (also known as CLR 131), CLR 1900 series, CLR 2000 series and CLR 12120; our ability to continue development plans for our Phospholipid Drug Conjugates (PDC) ; our ability to maintain orphan drug designation in the U.S. for iopofosine as a therapeutic for the treatment of multiple myeloma, neuroblastoma, osteosarcoma, rhabdomyosarcoma, Ewing's sarcoma and lymphoplasmacytic lymphoma, and the expected benefits of orphan drug status; any disruptions at our sole supplier of iopofosine; our ability to pursue strategic alternatives; our ability to advance our technologies into product candidates; our enhancement and consumption of current resources along with ability to obtain additional funding; our current view regarding general economic and market conditions, including our competitive strengths; the future impacts of the COVID-19 pandemic on our business, employees, operating results, ability to recruit patients for clinical studies, ability to obtain additional funding, product development programs, research and development programs, suppliers and third-party manufacturers; uncertainty and economic instability resulting from conflicts, military actions, terrorist attacks, natural disasters, public health crises, including the occurrence of a contagious disease or illness such as the COVID-19 pandemic, cyber-attacks and general instability; the future impacts of legislative and regulatory developments in the United States on the pricing and reimbursement of our product candidates; our ability to meet the continued listing standards of Nasdaq; assumptions underlying any of the foregoing; any other statements that address events or developments that we intend or believe will or may occur in the future; as well as our ability to complete enrollment and release top-line data from the WM CLOVER-WaM trial in the second half of 2023, our ability to receive break-through therapy approval and NDA approval for our iopofosine I 131 program and our ability to commercially manufacture and launch our product candidate if we receive regulatory approval. 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, 2022, and our Form 10-Q for the quarter ended September 30, 2023.
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 therein.
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Cellectar: Highlights
Discovering and Developing the Next Generation of Drug Conjugates
Proprietary phospholipid ether drug conjugate (PDC) platform with the demonstrated ability to deliver a broad array of therapeutic modalities to target cancers
Iopofosine I 131 achieved primary endpoint in Waldenstrom's macroglobulinemia (WM) CLOVER-WaM pivotal study
Industry-leading phospholipid radiotherapeutic conjugate (PRC) franchise with demonstrated clinical activity in hematologic malignancies
The only radiotherapeutic with "off the shelf" global distribution; logistics provide secure and
redundant supply to outpatient setting
Received milestone-based funding of $44M post CLOVER-WaMtop-line data release
Successful WM Pivotal Study Topline Data Supports 2H24 NDA Submission
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Phospholipid Drug
Conjugate (PDC)
Platform & Pipeline
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Phospholipid Drug Conjugate Platform (PDC): MOA
Universal Targeting with Diverse Payloads
(1) PDC containing desired payload with | (2) Specific targeting of lipid raft on | (3) Intercellular delivery and release of payload |
tumor-targeting phospholipid ether | cancer cell membrane | by transmembrane flipping of lipid raft |
PDCs
Profile | Diverse | Pan-cancer | Cancer specific | Rapid | CNS | Cytoplasmic | ||
Payload | Targeting | Target | Uptake | Penetration | Entry | |||
Phospholipid Drug | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Conjugate1 (PDC) | ||||||||
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PDC Platform: Pipeline
MOA - Therapeutic Franchises
Franchise Payloads
Radiotherapeutic (PRC)
Cytotoxic Molecule (PCC)
Biologics (PPC)
Nucleic Acid (POC)
Conjugates
Radio-conjugate
- Targeted delivery of any radioisotope
- Alpha and beta emitters
- Iopofosine I 131 in a pivotal study
Small-molecule Conjugates
- Demonstrated in-vivo safety and efficacy in multiple animal models
- Pico and nanomolar activity
Peptide and Nanobody Conjugates
- Targeting intracellular pathways that cannot be targeted with small molecules
Oligo Conjugates
- Intracellular delivery of nucleic acids providing knockdown or knock-in gene control in cancer cells
MOA
- Beta emitter (131I, 177Lu, 90Y, 67Cu, etc.)
- Alpha emitter (211At, 225Ac, 223Ra, 213Bi, etc.)
- Additional isotopes (153Gd, 67Ga, Auger, etc.)
- PLK-1
- Seco-duba
- MMAF
- Other small molecules
- Ribosomal peptide
- Protein inhibitors
- RNAi-/siRNA
- mRNA
- cDNA
Platform Enables Value Creation Across a Broad Range of Therapeutic Modalities
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PDC Platform: Expected Pipeline Milestones 2024-2025
2024 | 2025 | ||||||
1H | 2H | 1H | 2H | ||||
Iopofosine | Waldenstrom's | Top Line Data - Jan | NDA Submission | Planned Launch | |||
macroglobulinemia2 | Updated Q2 | ||||||
I 131 | |||||||
B-Cell Malignancies | Ph 2a Enrollment | Initiate Ph 2b | |||||
β-emitting | MM, pCNSL | Completed | |||||
radiotherapeutic | |||||||
Pediatric | Commence | Ph 1b Interim | Ph 1b | ||||
pHGG | Enrollment | Assessment | Trial Results | ||||
CLR 121225 | IND Enabling | Ph 1 | |||||
α-emitting | Solid Tumor | IND Filing | |||||
Studies | Initiation | ||||||
radiotherapeutic | |||||||
PRC | Discovery | Development | |||||
(isotope TBD) | Candidate Identified | ||||||
Early Pipeline | Discovery | Development | |||||
Candidate Identified | |||||||
Manufacturing | Iopofosine I 131/ | Establish Iopofosine | CLR 121225 | ||||
CLR 121225 | EU Manufacturing | GMP Supply | |||||
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Radiotherapy
Competitive Landscape
Market & MOA
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Radiotherapy Competitive Landscape: Approved & Late-Stage Programs
Focus - Metastatic Prostate Cancer (mPC) & Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET)
3 approved products
• 2 mPC
• 1 GEP-NET
8 programs in pivotal studies
• 3 mPC
• 3 GEP-NET
• 1 AML (hospital in-patient care)
• 1 WM (out-patient care)
Significant Product Development and Commercialization
Opportunity Exists in Hematologic and Solid Tumor Markets
Indication Key
GEP-NETs mPC
WM
AML | 9 |
Radiotherapy Competitive Landscape: Patent Portfolios
Top Pharmaceutical Companies Ranked by Applications and Grants for Radiopharmaceuticals
Extensive Patent Portfolio Positions Cellectar
as a Radiopharmaceutical Intellectual Property Leader
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Disclaimer
Cellectar BioSciences Inc. published this content on 17 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 18 March 2024 11:03:03 UTC.