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Item 1. Business

2025-03-13 compared with 2024-03-27 · 172 added, 138 removed, 708 unchanged (30% of the section changed)

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We believe that our PDC platform possesses the potential for the discovery and development of the next generation of cancer-targeting treatments, and we plan to develop PDCs both independently and through research and development collaborations.

Our lead PDC therapeutic, iopofosine I 131 (iopofosine) is a small-molecule PDC designed to provide targeted delivery of iodine-131 directly to cancer cells, while limiting exposure to healthy cells.

We believe this profile differentiates iopofosine from many traditional on-market treatments and radiotherapeutics.

Our CLOVER-WaM Phase 2 pivotal study of iopofosine in patients with relapsed/refractory (r/r) Waldenstrom’s macroglobulinemia (WM) has completed, and our Phase 2b studies in r/r multiple myeloma (MM) patients and r/r central nervous system lymphoma (CNSL) are ongoing.

The Company is primarily focused on the development of its radioconjugate PDC programs, also known as phospholipid radioconjugates or PRCs, designed to provide targeted delivery of a radioisotope directly to cancer cells, while limiting exposure to healthy cells.

We believe this profile differentiates our PRCs from many traditional on-market treatments and radiotherapeutics.

Our three lead programs are:

iopofosine I 131 (iopofosine), a beta-emitting iodine-131 based program which has been studied extensively, as described below;

CLR 121225, an actinium-225 based program;

and CLR 121125, an iodine-125 Auger-emitting program, both prepared to enter clinical trials in 2025.

● Iopofosine, the beta-emitting PRC, utilizes iodine-131 and was studied in our CLOVER-WaM Phase 2 study of iopofosine in patients with relapsed/refractory (r/r) Waldenstrom’s macroglobulinemia (WM), and our Phase 2b studies in r/r multiple myeloma (MM) patients and r/r central nervous system lymphoma (CNSL) are ongoing.

The CLOVER-2 Phase 1a study for a variety of pediatric cancers has concluded and a Phase 1b study in pediatric patients with high grade glioma is enrolling.

Additionally, a Phase 1 Investigator-initiated study conducted by the University of Wisconsin Madison of iopofosine I 131 in combination with external beam radiation in patients with recurrent head and neck cancer has also completed.

Additionally, a Phase 1 Investigator-initiated study conducted by the University of Wisconsin Madison of iopofosine in combination with external beam radiation in patients with recurrent head and neck cancer has also been completed.

As with all clinical trials, adverse events, serious adverse events or fatalities may arise during a clinical trial resulting from medical problems that may not be related to clinical trial treatments.

The CLOVER-1 Phase 2 study, conducted in r/r B-cell malignancies, met the primary efficacy endpoints from the Part A dose-finding portion.

Furthermore, due to recent communications with the FDA regarding a confirmatory study to support accelerated approval and the regulatory submission for iopofosine, the Company is, in addition to determining the availability of funding for such a study, pursuing strategic options for the further development and commercialization of this product candidate.

● CLR 121225, the alpha-emitting, actinium-225 based PRC has demonstrated activity in multiple solid tumor animal models, including pancreatic, colorectal, and breast cancer.

CLR 121225 has been shown to be well tolerated in these models with the animals showing no adverse events at the highest doses tested.

It was also shown that the compound has excellent biodistribution and uptake by the tumor.

Furthermore, in multiple models of pancreatic adenocarcinoma, including highly refractory pancreatic cancer, we have observed the compound’s proportional dose response with a single dose providing either tumor stasis at the lowest dose tested or tumor volume reduction at the higher doses.

The Company is currently projected to be the subject of a Phase 1 imaging and dose escalation safety study in the first half of 2025.

● CLR 121125, the Auger-emitting PRC, utilizes iodine-125 and has demonstrated excellent tolerability with no toxicities in animal models.

Additionally, CLR 121125 has been shown to have good activity in multiple solid tumor models, especially in triple negative breast cancer.

Auger emitters provide the greatest precision in targeted radiotherapy as the emission can only travel a few nanometers.

This means that to cause the necessary breakage of the tumor cell DNA, the isotope most get inside the cell and near the cell nucleus to be effective.

CLR 121125 achieves this due to the Company’s novel phospholipid ether drug conjugate platform.

CLR 121125 is prepared to be the subject of a Phase 1b dose finding study in the first half of 2025.

The CLOVER-1 Phase 2 study of iopofosine, conducted in r/r B-cell malignancies, met the primary efficacy endpoints from the Part A dose-finding portion.

The CLOVER-1 Phase 2b study, where iopofosine remains under further evaluation in highly refractory MM and CNSL patients, is ongoing.

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The study completed enrollment in the fourth quarter of 2023, and initial top line data from the study was reported in January 2024.

CLOVER-WaM was a single-arm study with a target enrollment of 50 patients.

WaM was a single-arm study with a target enrollment of 50 patients.

Topline safety data was reported on 45 patients meeting criteria for the modified Intent to Treat (mITT) population with a data cut-off date of January 3, 2024.

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The overall response rate (ORR) in evaluable patients was 75.6%, and 100% of patients experienced disease control.

Responses were durable, with median duration of response not reached and 76% of patients remaining progression free at a median follow-up of eight months.

Responses were durable, with median duration of response not reached with 11.4 months of follow-up and 76% of patients remaining progression free at a median follow-up of eight months.

These outcomes exceed real world data, which demonstrate a 4-12% MRR and a duration of response of approximately six months or less despite continuous treatment in a patient population that is less pretreated and not refractory to multiple classes of drugs.

Notably, iopofosine I 131 monotherapy achieved an 7.3% complete remission (CR) rate in this highly refractory WM population.

Notably, iopofosine I 131 monotherapy achieved a 7.3% complete remission (CR) rate in this highly refractory WM population.

Iopofosine I 131 was well tolerated and its toxicity profile was consistent with the Company’s previously reported safety data.

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SME status allows us to participate in significant financial incentives that include a 90% to 100% EMA fee reduction for scientific advice, clinical study protocol design, endpoints and statistical considerations, quality inspections of facilities and fee waivers for selective EMA pre-and post-authorization regulatory filings, including orphan drug and PRIME designations.

We are also eligible to obtain EMA certification of quality and manufacturing data prior to review of clinical data.

We are also eligible to obtain EMA certification of quality and manufacturing data prior to a review of clinical data.

Other financial incentives include EMA-provided translational services of all regulatory documents required for market authorization, further reducing the financial burden of the market authorization process.

Our product pipeline also includes a PDC-based alpha-emitter radiotherapeutic series (CLR12120) in IND enabling studies, preclinical PDC small molecule chemotherapeutic programs, an oligo-conjugate program, a peptide-conjugate program, and several partnered PDC assets.

We are evaluating the CLR 12120 series with multiple alpha emitting isotopes, such as actinium and astatine in both solid and hematologic malignancies.

The other programs are being developed for solid tumors.

We are also evaluating other alpha-emitting isotopes such as astatine-211 and lead-212 in preclinical studies.

Additionally, we have preclinical PDC programs focused on the delivery of conjugated small molecule chemotherapeutic compounds, oligonucleotides and peptides to solid tumors.

We have leveraged our PDC platform to establish three ongoing collaborations featuring four unique payloads and mechanisms of action.

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Our PDCs are designed to bind to these regions and directly enter the intracellular compartment.

This mechanism allows the PDC molecules to accumulate in tumor cells over time, which we believe can enhance drug efficacy.

This mechanism

allows the PDC molecules to accumulate in tumor cells over time, which we believe can enhance drug efficacy.

The direct intracellular delivery allows our molecules to avoid the specialized, highly acidic cellular compartment known as lysosomes, which allows a PDC to deliver payloads that previously could not be delivered in this targeted manner.

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Additionally, the epitope utilized is also present on other normal tissue, resulting in off-target toxicities.

Beyond the benefits provided by the mechanism of entry, the PDC platform features include the capacity to link with almost any molecule, provide a significant increase in targeted oncologic payload delivery, a more uniform delivery, and the ability to target all types of tumor cells.

As a result, we believe that we can create PDCs to treat a broad range of cancers with the potential to improve the therapeutic index of oncologic drug payloads, enhance or maintain efficacy while also reducing adverse events by minimizing drug delivery to healthy cells, and increasing delivery to cancerous cells and cancer stem cells.

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Our iterative process allows us to rapidly and systematically produce multiple generations of incrementally improved targeted drug candidates without the expense of having to generate significant compound libraries.

A description of our PDC product candidates follows:

Clinical Pipeline

Our lead PDC therapeutic, iopofosine, is a small-molecule PDC designed to provide targeted delivery of iodine-131 directly to cancer cells, while limiting exposure to healthy cells.

We believe this profile differentiates iopofosine from many traditional on-market treatments and treatments in development.

Iopofosine was recently evaluated in the completed CLOVER-WaM Phase 2 pivotal study in patients with r/r WM, while evaluation is ongoing in a Phase 2b study in r/r MM and CNS lymphoma patients and the CLOVER-2 Phase 1b study for pediatric patients with high grade gliomas.

Our lead clinical programs are:

iopofosine, an iodine-131 beta-emitting program;

CLR 121225, an actinium-225 based program;

and CLR 121125, an iodine-125 Auger-emitting program.

All three of these product candidates are designed to provide targeted delivery of the respective radioisotope directly to cancer cells, while limiting exposure to healthy cells.

We believe this profile differentiates our PRCs from many traditional on-market treatments and treatments in development.

Iopofosine was evaluated in the recently completed CLOVER-WaM Phase 2 pivotal study in patients with r/r WM, while evaluation is ongoing in a Phase 2b study in r/r MM and CNS lymphoma patients and the CLOVER-2 Phase 1b study for pediatric patients with high grade gliomas.

Adverse events across all studies have been largely restricted to fatigue (39%), and cytopenias;

specifically, thrombocytopenia (75%), anemia (61%), neutropenia (54%), leukopenia (56%), and lymphopenia (34%).

Fatalities resulting from infection have occurred in patients treated with iopofosine.

Fatalities have occurred in patients post-treatment with iopofosine.

The CLOVER-WaM pivotal Phase 2b study completed enrollment of WM patients that have received at least two previous lines of therapy including those that failed or had a suboptimal response to a BTKi therapy in 4Q 2023.

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The ORR in evaluable patients was 75.6%, and 100% of patients experienced disease control.

Responses were durable, with median duration of response not reached and 76% of patients remaining progression free at a median follow-up of eight months.

Responses were durable, with median duration of response not reached with 11.4 months of follow-up and 76% of patients remaining progression free at a median follow-up of eight months.

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The initial Investigational New Drug (IND) application was accepted by the FDA in March 2014 with multiple INDs submitted since that time.

The Phase 1 study was designed to assess the compound’s safety and tolerability in patients with r/r MM and to determine maximum tolerated dose (MTD), and was initiated in April 2015.

The Phase 1 study was designed to assess the compound’s safety and tolerability in patients with r/r MM

and to determine maximum tolerated dose (MTD) and was initiated in April 2015.

The study completed enrollment, and the final clinical study report is expected in the first half of 2025.

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The FDA granted Fast Track designation for iopofosine for the treatment of r/r LPL and WM in May 2020.

As the result of iopofosine’s RPDD designation, we may be eligible to receive a priority review voucher (PRV) if the product receives approval for any of the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma or osteosarcoma.

award PRV to sponsors of a product application for a RPDD that meet its specified criteria.

The key criteria to receiving PRV is that the drug be approved for a rare pediatric disease and treat a serious or life-threatening manifestation of the disease or condition that primarily affects individuals under the age of 18.

In order to receive a PRV, a sponsor must obtain approval of a “rare pediatric disease product application,” which is a human drug application for prevention or treatment of a rare pediatric disease and which contains no active ingredient, including any ester or salt thereof, that has been approved by the FDA;

is deemed eligible for priority review;

is submitted under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA) or section 351(a) of the Public Health Service Act (PHSA);

relies on clinical data derived from studies examining a pediatric population and dosages of the drug intended for that population;

does not seek approval for an adult indication in the original rare pediatric disease application;

and is approved after September 30, 2016.

Under this program, a sponsor who receives an approval for a drug or biologic for a rare pediatric disease can receive a PRV that can be redeemed to receive a priority review of a subsequent marketing application for a different product.

Additionally, the PRV’s can be exchanged or sold to other companies so that the receiving company may use the voucher.

Congress has only authorized the rare pediatric disease priority review voucher program until September 30, 2024.

However, if a drug candidate receives RPDD before September 30, 2024, it is eligible to receive a voucher if it is approved before September 30, 2026.

Phase 2 Pivotal Study in:

Patients with r/r Waldenstrom’s Macroglobulinemia

Phase 2 Pivotal Study in Patients with r/r Waldenstrom’s Macroglobulinemia

We participated in a Type C guidance meeting with the FDA in September 2020.

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If three of the 10 patients experienced a Clinically Significant Toxicity (CST) then the dose would have been reduced to 12.5 mCi/m2.

We believe this design aligned with the feedback received from the FDA during the guidance meeting held in September 2020 and subsequent interactions.

We believed this design aligned with the feedback received from the FDA during the guidance meeting held in September 2020 and subsequent interactions.

The FDA accepted the dose to be tested, our proposal for a safety and futility assessment to be conducted on the first 10 patients, the endpoint to be assessed, the statistical analysis plan and study size of approximately 50 patients in the mITT population (>60mCi TBD).

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The overall response rate (ORR) in evaluable patients was 75.6%, and 100% of patients experienced disease control.

Responses were durable, with median duration of response not reached and 76% of patients remaining progression free at a median follow-up of eight months.

Responses were durable, with median duration of response not reached with 11.4 months of follow-up and 76% of patients remaining progression free at a median follow-up of eight months.

Notably, iopofosine monotherapy achieved an 7.3% complete remission (CR) rate in this highly refractory WM population.

Notably, iopofosine monotherapy achieved a 7.3% complete remission (CR) rate in this highly refractory WM population.

Iopofosine I 131 was well tolerated and its toxicity profile was consistent with the Company’s previously reported safety data.

There were no treatment-related adverse events (TRAEs) leading to discontinuation.

The rates of Grade 3 or greater TRAEs observed in more than 10% of patients included thrombocytopenia (55%), neutropenia (37%), and anemia (26%).

The rates of Grade 3 or greater TRAEs observed in

more than 10% of patients included thrombocytopenia (55%), neutropenia (37%), and anemia (26%).

All patients recovered from cytopenias with no reported aplastic sequalae.

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We believe this may represent an important improvement in the treatment of r/r WM as we believe no approved or late-stage development treatments for second- and third-line patients have reported a CR to date.

Based on study results to date, patients continue to tolerate iopofosine well, with the most common adverse events being cytopenias and fatigue.

Based on study results, patients continue to tolerate iopofosine well, with the most common adverse events being cytopenias and fatigue.

Phase 2a Study:

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Based on study results to date, patients continue to tolerate iopofosine well, with the most common and almost exclusive treatment-emergent adverse events are cytopenias, such as thrombocytopenia, neutropenia, and anemia.

In December 2021, we presented data from 11 MM patients from our ongoing Phase 2 CLOVER-1 study in a poster at the American Society of Hematology (ASH) Annual Meeting and Exposition.

In December 2021, we presented data from 11 MM patients from our Phase 2 CLOVER-1 study in a poster at the American Society of Hematology (ASH) Annual Meeting and Exposition.

The MM patients were at least triple class refractory (defined as refractory to an immunomodulatory agent, proteasome inhibitor and monoclonal antibody) with data current as of May 2021.

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We continue to enrich the r/r MM patient cohort with patients that are even more refractory, specifically enrolling patients that are quad-class refractory (triple class plus refractory to any of the recent approved product classes) and have relapsed post-BCMA immunotherapy.

We reported in the Blood Cancer Journal in August 2022 that iopofosine demonstrated a 50% ORR in patients receiving > 60mCi total administered dose (3/6 patients).

We reported in the Blood Cancer Journal in August 2022 that we observed iopofosine had a 50% ORR in patients receiving >60mCi total administered dose (3/6 patients).

Patients with r/r non-Hodgkin’s Lymphoma Cohort

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In addition to these findings, subtype assessments were completed in the r/r B-cell NHL patients.

Patients with DLBCL demonstrated a 30% ORR with one patient achieving a CR, which continues at nearly 24 months post-treatment.

We observed a 30% ORR in patients with DLBCL, with one patient achieving a CR, which continues at nearly 24 months post-treatment.

The ORR for CLL/SLL and MZL patients was 33%.

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Cohort seven was the highest pre-planned dose cohort and subjects have completed the evaluation period.

The study completed enrollment and the final clinical study report is expected in the first half of 2022.

Adverse events occurring in at least 25% of subjects were fatigue (26%) and cytopenias, specifically, thrombocytopenia (90%), anemia (65%), neutropenia (55%), leukopenia (61%), and lymphopenia (58%).

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Secondary objectives of the study are to identify the recommended efficacious dose of iopofosine and to determine preliminary antitumor activity (treatment response) of iopofosine in children and adolescents.

the FDA granted ODD and RPDD for iopofosine for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma.

In August 2020, based on data on four dose levels from 15mCi/m2 up to 60mCi/m2, the iDMC permitted the beginning of the evaluation of the next higher dose cohort, at 75mCi/m2.

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In 2022, the NCI awarded Cellectar a $1,900,000 SBIR Phase 2 grant to explore iopofosine in pediatric HGG.

In 2018, the FDA granted ODD and RPDD for iopofosine for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma.

If iopofosine should be approved for any of these pediatric indications, the first approved RPDD would enable us to receive a priority review voucher.

Priority review vouchers can be used by the sponsor to receive priority review for a future New Drug Application (NDA) or Biologic License Application (BLA) submission, which would reduce the FDA review time from 12 months to six months.

Currently, these vouchers can also be transferred or sold to another entity.

In December 2020, the FDA extended the Priority Review Voucher Program through September 2026 for rare pediatric diseases.

Phase 1 Study in r/r Head and Neck Cancer

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Complete remission was achieved in 64% of patients, with an ORR of 73% (n=11).

Prior to treatment with iopofosine I 131, six patients had multiple recurrence and one had metastatic disease, both of which are indicative of poor outcomes.

Additionally, the study demonstrated durability of tumor control with an overall survival of 67% and progression free survival of 42% at 12 months.

Prior to treatment with iopofosine I 131, six patients had multiple recurrences, and one had metastatic disease, both of which are indicative of poor outcomes.

Additionally, in the study we observed durability of tumor control with an overall survival of 67% and progression free survival of 42% at 12 months.

Eleven patients (92%) experienced a treatment-related adverse event.

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Preclinical Pipeline

We believe our PDC platform has potential to provide targeted delivery of a diverse range of oncologic payloads, as exemplified by the product candidates listed below, that may result in improvements upon current standard of care (SOC) for the treatment of a broad range of human cancers:

● CLR 12120 Series is an alpha emitting radio-conjugate program.

The company has validated the in vivo potential of alpha emitting phospholipid radioconjugates and their potential to treat highly refractory and difficult to treat solid tumors.

Cellectar is currently progressing with a lead molecule using actinium-225 as the alpha emitting payload.

We believe our PDC platform has potential to provide targeted delivery of a diverse range of oncologic payloads, as exemplified by our lead product candidates:

iopofosine, CLR 121225, and CLR 121125, as discussed above.

Additional pipeline product candidates, listed below, may also result in improvements to the current standard of care (SOC) for the treatment of a broad range of human cancers:

● The company has developed a series of proprietary small molecule phospholipid drug conjugates.

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Many of these molecules have demonstrated efficacy and tolerability in preclinical mouse models.

The collaboration with IntoCell Inc., successfully met its agreed upon endpoint.

The collaboration provided significant data which has led Cellectar to select a series of highly potent cytotoxic small molecule payloads for further development.

The collaboration with IntoCell Inc.

successfully met its agreed upon endpoint.

The collaboration provided

significant data which has led Cellectar to select a series of highly potent cytotoxic small molecule payloads for further development.

● In collaboration with other parties, Cellectar has also validated that the PLE is capable of delivering peptide payloads and oligonucleotide (siRNA, mRNA, etc.) payloads to the tumors when delivered systemically.

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Non-radioactive molecules, including many classes of small molecule chemotherapeutic compounds, oligos, peptides and other molecules can also be attached to the delivery vehicle.

In parallel to advancing the clinical development of our lead PDC, iopofosine, in both adult and pediatric orphan indications, we remain focused on exploring the creation of additional PDCs ranging from newly discovered to well-characterized anti-cancer agent payloads.

The objective is to develop PDC chemotherapeutics through conjugation of our delivery vehicle and non-targeted anti-cancer agents to improve therapeutic indices and expand potential indications through the targeted delivery of chemotherapeutic payloads Other than CLR 12120, all are from non-radiotherapeutic treatment modalities, i.e.

In parallel to advancing the clinical development of our lead PDCs in both adult and pediatric orphan indications, we remain focused on exploring the creation of additional PDCs ranging from newly discovered to well-characterized anti-cancer agent payloads.

Other than CLR 12120, all are from non-radiotherapeutic treatment modalities, i.e.

small-molecule, peptide, or oligonucleotide cancer-targeting chemotherapeutics in pre-clinical research.

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Mice without intact immune systems and inoculated with Panc-1 (pancreatic carcinoma) cells, were injected with CLR 1502, 24 or 96 hours prior to imaging.

In vivo optical imaging showed pronounced accumulation of CLR 1502 in tumors versus non-target organs and tissues.

In vivo optical imaging showed pronounced accumulation of CLR 1502 (a fluorescent-labeled PDC) in tumors versus non-target organs and tissues.

Similarly, positron emission tomography (PET) imaging of tumor-bearing animals (colon, glioma, triple negative breast, and pancreatic tumor xenograft models) administered the imaging agent CLR 124 clearly shows selective uptake and retention by both primary tumors and metastases, including cancer stem cells.

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Products in Development

Iopofosine is a small molecule, radioconjugate, composed of our proprietary PLE, 18-(p-[I-131]iodophenyl) octadacyl phosphocholine, acting as a cancer-targeting delivery and retention vehicle, covalently labeled with iodine-131, a cytotoxic (cell-killing) radioisotope with a half-life of eight days that is already in common use to treat thyroid, pediatric tumors and other cancer types including NHL.

Iopofosine binds to the cell surface of cancer cells and is delivered into the cytoplasm of the cancer cell.

Iopofosine is a radioconjugate, composed of our proprietary PLE, 18-(p-[I-131]iodophenyl) octadacyl phosphocholine, acting as a cancer-targeting delivery and retention vehicle, covalently labeled with iodine-131, a cytotoxic (cell-killing) radioisotope with a half-life of eight days that is already in common use to treat thyroid, pediatric tumors and other cancer types including NHL.

Iopofosine binds to the cell surface and is delivered into the cytoplasm of the cancer cell.

It is this “intracellular radiation” mechanism of cancer cell killing, coupled with delivery to a wide range of malignant tumor types that we believe provides iopofosine with anti-cancer activity and a unique product profile.

Selective uptake and retention have been demonstrated in cancer stem cells compared with normal cells, offering the prospect of longer lasting anti-cancer activity.

Selective uptake and retention have been observed in cancer stem cells compared with normal cells, offering the prospect of longer lasting anti-cancer activity.

CLR 121225 is our lead alpha emitting, actinium-225, based radioconjugate program.

The compound has demonstrated activity in multiple solid tumor animal models, including pancreatic, colorectal, and breast cancer.

CLR 121225 has been shown to be well tolerated in these models with the animals showing no adverse events at the highest doses tested.

It was shown that the compound has excellent biodistribution and uptake by the tumor.

We are currently preparing to initiate a Phase 1 imaging and dose escalation safety study in the first half of 2025.

CLR 121125 is our lead Auger-emitting radioconjugate program.

The compound utilizes iodine-125 and has demonstrated excellent tolerability with no toxicities in animal models.

Additionally, CLR 121125 has been shown to have good activity in multiple solid tumor models and especially in triple negative breast cancer.

Auger emitters provide the greatest precision in targeted radiotherapy as the emission can only travel a few nanometers.

This means to cause the necessary breakage of the tumor cell DNA, the isotope must get inside the cell and near the cell nucleus to be effective.

CLR 121125 achieves this due to our novel phospholipid ether drug conjugate platform.

CLR 121125 is currently projected to be the subject of a Phase 1b dose finding study in the first half of 2025.

Tumor treatment with radioactive isotopes has been used as a fundamental cancer therapeutic for decades.

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This strategy has allowed us to take a multi-indication approach in the development and potential commercialization of iopofosine.

To date, the Company has focused on rare cancers with significant unmet need including WM, MM, sarcomas, and HGG, among others.

To date, we have focused on rare cancers with significant unmet need including WM, MM, sarcomas, and HGG, among others.

Market Overview

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in 2025 and approximately 618,120 cancer deaths in the U.S.

The global market for cancer drugs reached $148 billion in annual sales (2020), and with a compound annual growth rate (CAGR) of 7.7% could reach $288 billion by 2030, according to a report dated August 2022 by Straits Research.

This growth will be driven by emerging targeted therapies, which are expected to change the cancer treatment landscape (Cowen Report 2020), and an increased use of cancer drug combination regimens.

The global market for cancer drugs reached $231 billion in annual sales (2024), and with a compound annual growth rate (CAGR) of 12.6% could reach $532 billion by 2031, according to a report dated October 2024 by Coherent Market Insights.

This growth will be driven by regulatory approvals, fierce competition, and an aging population (Global Data Research Group 2023), and an increased adoption of cell and gene therapies, antibody-drug conjugates, multispecific antibodies, and radioligand therapies.

Waldenstrom’s Macroglobulinemia

WM is a rare and incurable disease defined by specific genotypic subtypes that defines patient responses and long-term outcomes.

WM is a rare and incurable disease defined by specific genotypic subtypes that define patient responses and long-term outcomes.

annual incidence is 1,500 - 1,900 with prevalence of approximately 26,000 and 110,000 patients globally.

WM is a lymphoma, or cancer of the lymphatic system.

The disease occurs in a type of white blood cell called a B-lymphocyte or B-cell, which normally matures into a plasma cell that plays an important part in the body’s immune system by manufacturing immunoglobulins (antibodies) to help the body fight infection.

(antibodies) to help the body fight infection.

In WM, there is a malignant change to the B-cell in the late stages of maturing, and it continues to proliferate into a clone of identical cells, primarily in the bone marrow but also in the lymph nodes and other tissues and organs of the lymphatic system.

These clonal cells over-produce an antibody of a specific class called IgM.

These clonal cells overproduce an antibody of a specific class called IgM.

WM cells have characteristics of both cancerous B-lymphocytes (NHL) and plasma cells (MM), and they are called lymphoplasmacytic cells.

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Front-line treatments for WM include rituximab alone or in combination with other agents, including ibrutinib.

In the salvage therapy (second line or later) setting, BTKi’s, and other combinations are considered (bendamustine,

proteosome inhibitors, etc.).

In the salvage therapy (second line or later) setting, BTKi’s, and other combinations are considered (bendamustine, proteosome inhibitors, etc.).

Ibrutinib and zanubrutinib are the only drugs to receive regulatory approval (in 2015 and 2020, respectively) as a salvage therapy;

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Multiple Myeloma

According to the National Cancer Institute SEER database, multiple myeloma is the second most common hematologic cancer with a U.S.

According to the National Cancer Institute SEER database, multiple myeloma (MM) is the third most common hematologic cancer with a U.S.

incidence rate of 36,110 and a relapse or refractory patient population of 43,727.

In 2022, Datamonitor Healthcare estimated the MM dollar market size to be over $23B in 2023 and is forecasted to increase to nearly $47B in 2031.

In 2024, Global Data estimated MM global market to be over $24B in 2024 and is forecasted to increase to nearly $29B in 2032.

The increase in drug sales over this period will be mainly driven by the increasing incidence of MM with the U.S.

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It is believed the largest growth will occur in patients receiving at least three lines of treatment because of the expanding elderly population, increases in treatment population and increasing rates of survival from earlier lines of treatment.

According to data obtained from Decision Resource Group, over 40% of patients in later lines of therapy, while eligible, refuse treatment because of higher treatment failure, severity of adverse events and difficulty of treatment dosing regimen.

The average response rates for patients receiving their fourth and fifth-line treatment are 15% and 8% response rates, respectively.

Additionally, the mOS for these patients also decreases by line of therapy and is less than 9 months post third-line treatment.

Based on the iopofosine Phase 1 and Phase 2 product profile demonstrated in fifth-line patients to date, we believe iopofosine may address the unmet medical need in the heavily pre-treated patient population described above.

According to data obtained from Decision Resources Group, over 40% of patients in later lines of therapy, while eligible, refuse treatment because of higher treatment failure, severity of adverse events and difficulty of treatment dosing regimen.

Based on the iopofosine Phase 1 and Phase 2 product profile we observed in fifth-line patients to date, we believe iopofosine may address the unmet medical need in the heavily pre-treated patient population described above.

B-Cell Non-Hodgkin’s Lymphoma

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According to a report dated June 2019 by Global Data Research Group, the BCNHL market was valued at $8.3 billion for 2025, with a forecasted increase to $11.7 billion in 2032 at a CAGR of 4.9%.

We believe there is a significant unmet medical need in B-cell lymphoma as a result of continued high mortality and poor response rates remain in second and third- line treatments compounded by the limited durability of responses.

Based on the iopofosine Phase 2 product profile demonstrated in DLBCL patients to date treated with a single dose, we believe iopofosine may address the unmet medical need in the patient population described above as well.

We believe there is a significant unmet medical need in B-cell lymphoma as a result of continued high mortality and poor response rates in second and third- line treatments compounded by the limited durability of responses.

Based on the iopofosine Phase 2 product profile we observed in DLBCL patients to date treated with a single dose, we believe iopofosine may address the unmet medical need in the patient population described above as well.

Neuroblastoma

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Although treatment rates have improved within the clinical paradigm, half of children with neuroblastoma still relapse or fail to respond to upfront therapy.

Survival for those with relapsed or refractory neuroblastoma currently reports as a four-year overall survival rate of 20%.

Survival for those with high-risk relapsed or refractory neuroblastoma currently reports as a four-year overall survival rate of 20%.

High Grade Glioma

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Sarcomas represent 15% of all pediatric tumors and 21% of pediatric solid tumors.

The National Cancer Institute SEER database estimates that there were 2,060 incidences in 2019.

The median age at diagnosis was 3, the median age of death was 5.

The American Cancer Society estimates that there will be 3,770 cases diagnosed in 2025.

The median age at diagnosis is 16, and the median age of death is 18.

We are focused on 3 subsets of sarcomas:

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the tumors develop in the muscles – predominately skeletal muscle.

Based on information from Market Insights, Epidemiology, and Market Forecast, the global market value of the pediatric sarcoma market is expected to nearly double from $490 million in 2022 to $1.01 billion in 2029.

This growth is expected to be driven by the high rate of recurrence in pediatrics, increased incidence in select markets and new high-priced therapies coming to the market.

Based on information from Datamonitor Healthcare, the global value of the pediatric sarcoma market is expected to be $1.094 billion in 2025.

This growth is expected to be driven by the high rate of recurrence in pediatrics, increased incidence in select markets and new targeted therapies coming to the market.

Manufacturing

The Company has built a collaborative outsourcing model for supply of all its drug candidates and the key components.

This model allows the Company to source each isotope and finished product through a decentralized and distributed network of contract manufacturers.

As it relates to CLR 121225, it was announced in late 2024 that the one of the sources for actinium would be Northstar Medical Radioisotopes.

The Company continues to collaborate with other sources and expects to announce additional supply agreements in 2025.

The finished PRCs are currently supplied by either Atomvie or SpectronRx.

Both organizations specialize in radiopharmaceutical production and can supply multiple different finished, ready-to-use radiotherapeutics simultaneously.

Similar to the source of the isotopes, the Company expects to identify additional manufacturers of its PRCs as they advance through the clinic.

Iopofosine drug product is made via a five-step synthetic process.

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distribution from North America.

We have successfully executed large scale production of the drug substance via a contract manufacturing organization that has been inspected and approved by the FDA and the EMA.

We have also demonstrated 60-month stability for the drug substance in desiccated and refrigerated forms at small scale and are replicating this at large scale.

AtomVie (formerly known as The Centre for Probe Development and Commercialization (CPDC)), a validated Current Good Manufacturing Practices (cGMPs) manufacturing organization specializing in radiopharmaceuticals, is our primary source to supply drug product for our ongoing research and clinical studies, including our Phase 1 and Phase 2 studies of iopofosine.

We believe that AtomVie and our other third-party manufacturers have the ability to supply large scale clinical and commercial scale material.

We have successfully executed large scale production of iopofosine drug substance via a contract manufacturing organization that has been inspected and approved by the FDA and the EMA.

We have also observed 60-month stability for iopofosine drug substance in desiccated and refrigerated forms at small scale and are replicating this at large scale.

Sales and Marketing

According to Fortune Business Insights, the solid tumors market size reached a value of $170.3 billion in 2023, and the market is expected to reach $375.4 billion by 2034, exhibiting a growth rate (CAGR) of 7.45% during 2024-2034.

North America represents 44% of the global market with the Asia Pacific region expected to grow most rapidly during this period.

Pancreatic cancer is one of the leading causes of cancer death globally with the treatment market size valued at $2.86 billion in 2023.

The market is projected to grow from $3.30 billion in 2024 to $10.69 billion by 2032, exhibiting a CAGR of 15.8%.

pancreatic cancer treatment market size is projected to grow significantly and will represent nearly 50% of the global market.

According to the American Cancer Society, in the United States, pancreatic cancer is expected to affect 67,440 people in 2025, with 51,980 deaths.

According to the Pancreatic Cancer Action Network, the 5-year relative survival rate for pancreatic cancer is 13%.

Pancreatic cancer affects men and women nearly equally.

Triple-negative breast cancer (TNBC) is an aggressive type of invasive breast cancer.

TNBC differs from other types of invasive breast cancer in that it tends to grow and spread faster, has fewer treatment options, and tends to have a worse prognosis.

The term triple-negative breast cancer refers to the fact that the cancer cells don’t have estrogen or progesterone receptors (ER or PR) and also don’t produce any or much of the protein called HER2.

According to DelveInsight, TNBC represents 15-20% of all breast cancers and occurs most frequently in women under the age of 40.

According to Fact.MR the global TNBC treatment market size is estimated at $670.5 million in 2024 and will thereafter increase at a CAGR of 4.6%, to reach $1.04 billion by the end of 2034.

According to Global Data Research Group it is estimated that in 2025 there will be approximately 29,644 newly diagnosed cases of TNBC in the US.

The 5-year relative survival rate is 77% across all stages of the disease.

The US WM market represents approximately $2.1 billion and is a very concentrated market, with 15 states harboring 80% of the WM cases.

Based upon the concentrated nature of the US WM market, we plan to pursue building a scalable and efficient commercial team to commercialize iopofosine.

We are currently exploring options for the WM opportunity outside of the US market, which will seek to establish an arrangement with one or more biotechnology or pharmaceutical companies with strong product development and commercialization expertise and distribution infrastructure in Europe and parts of global markets.

We are currently exploring options for the WM opportunity outside of the US market, which will seek to establish an arrangement with one or more biotechnology or pharmaceutical companies having strong product development and commercialization expertise and distribution infrastructure in Europe and parts of global markets.

Potential Commercial Competition to Our Current and Future Clinical-Stage Compounds

Currently, many classes of approved products with various mechanisms of action exist, including immune-modulating agents, proteasome inhibitors, histone deacetylase inhibitors, monoclonal antibodies, corticosteroids, and traditional chemotherapeutics for the treatment of liquid and solid tumors.

There also remain a significant number of compounds being researched and developed for the

treatment of cancer.

We are focused on the product development and commercialization of adult and pediatric orphan designated indications with unmet clinical need.

While multiple adult hematology indications for iopofosine were evaluated, WM was selected based on iopofosine’s efficacy and safety profile demonstrated to date.

Other considerations such as the regulatory pathway, unmet clinical need, limited commercial competition and cost efficiencies were also assessed.

We believe iopofosine is a therapeutic option in either adult or pediatric relapse or refractory settings either as a monotherapy or in combination with currently approved agents, some of which are radio-sensitizing and maintain a differential adverse event profile from that of iopofosine.

There also remain a significant number of compounds being researched and developed for the treatment of cancer.

We are focused on the product development and commercialization of adult and pediatric orphan-designated indications with unmet clinical need, and believe that our core PDC technology provides a uniquely advantageous approach to cancer therapy utilizing the beta-, alpha- and Auger-emitting capabilities of iopofosine, CLR 121225, and CLR 121125, respectively.

Intellectual Property

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We have established a broad U.S.

and international intellectual property rights portfolio around our proprietary cancer-targeting PLE technology platform including iopofosine and our PDC Programs.

PDC Chemotherapeutic Programs

and international intellectual property rights portfolio around our proprietary cancer-targeting PLE technology platform including our PDC Programs.

In November 2015, we converted our previously filed provisional patent application for Phospholipid-Ether Analogs as Cancer Targeting Drug Vehicles to non-provisional US and International (PCT) patent applications and were published by the U.S.

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Furthermore, we received ODD from the European Union for MM in September 2019, and for WM in January 2021.

We expect to file additional orphan designations for other rare diseases.

We continue to evaluate iopofosine in additional hematologic and solid tumor orphan designated indications.

Our patents have a variety of expected expiration dates with some potentially being extended on a country-by-country basis.

In 2018, the FDA a granted orphan drug and a RPDD for iopofosine for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma.

We initiated a Phase 1 study in 2019.

We expect to continue to file patent applications and acquire licenses to other patents covering methods of use, composition of matter, formulation, method of synthesis and other patentable claims related to iopofosine and new PDCs.

Our patents have a variety of expected expiration

dates with some potentially being extended on a country-by-country basis.

In 2018, the FDA granted ODD and a RPDD for iopofosine for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma.

These patent applications will be filed in key commercial markets worldwide.

In addition to the above noted patents/applications directed to iopofosine and our PDC pipeline portfolio, we own other patents/applications directed to different forms of phospholipid ethers, methods of use and methods of manufacturing of phospholipid ethers.

In addition to the above noted patents/applications directed to iopofosine, CLR 121125, CLR 121225, and our PDC pipeline portfolio, we own other patents/applications directed to different forms of phospholipid ethers, methods of use and methods of manufacturing of phospholipid ethers.

Separate from any patent protection and following product approval by regulatory authorities, data exclusivity may be available for various compounds for up to 10 years on a country-by-country basis (e.g., up to five years in the U.S.

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However, because of the limited half-life and associated logistical challenges associated with lead-212, Cellectar elected to advance an alternative alpha-emitting radioisotope.

In July 2021, we entered into a co-development and commercialization collaboration with LegoChemBio, a clinical stage biotechnology company to utilize their proprietary drug conjugate linker-toxin platform to further enhance our portfolio of next generation PDC therapeutics.

In July 2021, we entered into a co-development and commercialization collaboration with LegoChem Bio, a clinical stage biotechnology company to utilize their proprietary drug conjugate linker-toxin platform to further enhance our portfolio of next generation PDC therapeutics.

Research and Development

Our primary activity to date has been research and development.

The research had historically been conducted at our facility in Madison, Wisconsin and through third-party laboratories and academic universities.

Starting in 2018, we no longer used the facility in Madison, Wisconsin for these activities.

Clinical development has been completed primarily through contract research organizations at hospitals and academic centers.

We have established a collaboration outsourcing model to leverage third-party expertise, accelerate project timelines, improve productivity and limit spend and fixed costs.

We have established a collaboration outsourcing model to leverage third-party expertise, accelerate project timelines, improve productivity and limit costs.

Our research and development expenses were approximately $26,136,000 and $27,266,000 for 2024 and 2023, respectively.

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In the US, the FDA approves and regulates drugs under the Federal Food, Drug, and Cosmetic Act (FDCA) and implementing regulations.

The failure to comply with requirements under the FDCA and other applicable laws at any time during the product development process, approval process or after approval may subject an applicant and/or sponsor to a variety of administrative or judicial sanctions, including refusal by the FDA to approve pending applications, withdrawal of an approval, imposition of a clinical hold, issuance of warning letters and other types of letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement of profits, or civil or criminal investigations and penalties.

hold, issuance of warning letters and other types of letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement of profits, or civil or criminal investigations and penalties.

The research, development, and approval process in the U.S.

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Submission of IND

An IND must be submitted to the FDA and become effective before studies in humans may commence.

An IND must be submitted to the FDA and become effective before human studies may commence.

An IND is an exemption from the FDCA that allows an unapproved new drug to be shipped in interstate commerce for use in an investigational clinical trial and a request for FDA authorization to administer an investigational drug to humans.

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At any time during this 30-day period, or thereafter, the FDA may raise concerns or questions about the conduct of the trials as outlined in the IND and impose a clinical hold or partial clinical hold.

In this case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can begin or resume.

In this case, the IND sponsor and the FDA must resolve any outstanding

concerns before clinical trials can begin or resume.

An IRB representing each institution participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that institution, and the IRB must conduct continuing review and reapprove the study at least annually.

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During Phase 1, sufficient information about the drug’s safety and tolerability, pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies.

In Phase 2, controlled clinical studies are generally conducted in larger groups of patients having the target disease or condition in order to determine the common short-term side effects and risks associated with the drug, and to obtain preliminary data

on the safety and effectiveness of the product candidate and optimal dosing.

This phase also helps determine further the safety profile of the product candidate.

In Phase 2, controlled clinical studies are generally conducted in larger groups of patients having the target disease or condition to determine the common short-term side effects and risks associated with the drug, and to obtain preliminary data on the safety and effectiveness of the product candidate and optimal dosing.

This phase also helps further determine the safety profile of the product candidate.

In Phase 3, large-scale clinical studies are generally conducted in patients having the target disease or condition to provide sufficient data of effectiveness and safety of the product candidate that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling, as required by U.S.

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Each domestic and foreign manufacturing establishment, including any contract manufacturers we may decide to use, must be listed in the NDA and must be registered with the FDA.

The application generally will not be approved until the FDA conducts a manufacturing inspection, approves the applicable manufacturing process and determines that the facility is in compliance with cGMP requirements.

Additionally, before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP.

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REMS use risk minimization strategies beyond professional labeling to ensure that the benefits of the product outweigh the potential risks.

To determine whether a REMS is needed, the FDA will consider the size of the population likely to use the product, seriousness of the disease or condition to be treated by the drug, expected benefit of the product, expected duration of treatment, seriousness of known or potential adverse events, and whether the product is a new molecular entity.

determine whether a REMS is needed, the FDA will consider the size of the population likely to use the product, seriousness of the disease or condition to be treated by the drug, expected benefit of the product, expected duration of treatment, seriousness of known or potential adverse events, and whether the product is a new molecular entity.

Under the Prescription Drug User Fee Act, as amended, the FDA receives fees for reviewing an NDA and supplements thereto, as well as annual fees for commercial manufacturing establishments and for approved products.

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The FDA may request additional information rather than accept an NDA for filing.

In this event, the application

must be resubmitted with the additional information.

In this event, the application must be resubmitted with that additional information.

The resubmitted application is also subject to review before the FDA accepts it for filing.

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The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

On the basis of the FDA’s evaluation of the NDA and accompanying information, including the results of the inspection of the manufacturing facilities, the FDA may issue an approval letter or a complete response letter.

Based on the FDA’s evaluation of the NDA and accompanying information, including the results of the inspection of the manufacturing facilities, the FDA may issue an approval letter or a complete response letter.

An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications.

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In addition, the Fast Track designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process.

A product may be designated as a Breakthrough Therapy if it is intended, either alone or in combination with one or more other products, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing available therapies on one or more clinically significant endpoints, such as

substantial treatment effects observed early in clinical development.

The FDA may take certain actions with respect to Breakthrough Therapies, including holding meetings with the sponsor throughout the development process;

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Significant and pervasive continuing legal and regulatory requirements also apply after FDA approval to market under an NDA.

These include, among other things, requirements related to adverse event and other reporting, product advertising and promotion, and ongoing adherence to cGMP requirements, as well as the need to submit appropriate new or supplemental applications and obtain

FDA approval for certain changes to the approved product labeling, or manufacturing process.

These include, among other things, requirements related to adverse events and other reporting, product advertising and promotion, and ongoing adherence to cGMP requirements, as well as the need to submit appropriate new or supplemental applications and obtain FDA approval for certain changes to the approved product labeling, or manufacturing process.

The FDA also enforces the requirements of the Prescription Drug Marketing Act and its implementing regulations which, among other things, impose various requirements in connection with the distribution of product samples to physicians.

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In addition, drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and state agencies and are subject to periodic unannounced inspections by the FDA and these state agencies for compliance with cGMP requirements.

Changes to the manufacturing process are strictly regulated and often require prior FDA approval before being implemented.

Changes to the manufacturing process are strictly regulated and often require prior FDA approval before implementation.

FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements upon the sponsor and any third-party manufacturers that the sponsor may decide to use.

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Orphan Drug Designation and Exclusivity

Under the Orphan Drug Act, the FDA may designate a drug product as an “orphan drug” if it is intended to treat a rare disease or condition, generally meaning that it affects fewer than 200,000 individuals in the US, or more in cases in which there is no reasonable expectation that the cost of developing and making a drug product available in the US for treatment of the disease or condition will be recovered from sales of the product.

recovered from sales of the product.

A company must request ODD before submitting an NDA for the drug and rare disease or condition.

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If a drug designated as an orphan drug ultimately receives marketing approval for an indication broader than what was designated in its orphan drug application, it may not be entitled to exclusivity.

Orphan exclusivity will not bar approval of another product under certain circumstances, including if a subsequent product with the

same drug for the same indication is shown to be clinically superior to the approved product on the basis of greater efficacy or safety, or providing a major contribution to patient care, or if the company with orphan drug exclusivity is not able to meet market demand.

Orphan exclusivity will not bar approval of another product under certain circumstances, including if a subsequent product with the same drug for the same indication is shown to be clinically superior to the approved product on the basis of greater efficacy or safety, or providing a major contribution to patient care, or if the company with orphan drug exclusivity is not able to meet market demand.

Pediatric Studies and Exclusivity

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The allowable patent term extension is typically calculated as one-half the time between the effective date of an IND application and the submission date of a NDA, plus the time between NDA submission date and the NDA approval date up to a maximum of five years.

The time can be shortened if the FDA determines that the applicant did not pursue approval with due diligence.

The time can be shortened if the FDA

determines that the applicant did not pursue approval with due diligence.

The total patent term after the extension may not exceed 14 years from the date of product approval.

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Exclusion may also be imposed if the government determines that an entity has committed acts that are prohibited by the federal Anti-Kickback Statute.

Although there are a number of statutory exceptions and regulatory safe harbors to the federal Anti-Kickback Statute protecting certain common business arrangements and activities from prosecution or regulatory sanctions, the exceptions and safe harbors are drawn narrowly, and practices that involve remuneration to those who prescribe, purchase, or recommend pharmaceutical and biological products, including certain discounts, or engaging such individuals as speakers or consultants, may be subject to scrutiny if they do not fit squarely within an exception or safe harbor;

products, including certain discounts, or engaging such individuals as speakers or consultants, may be subject to scrutiny if they do not fit squarely within an exception or safe harbor;

● the federal civil and criminal false claims laws and civil monetary penalty laws, including the civil False Claims Act (FCA), which prohibits, among other things, (i) knowingly presenting, or causing to be presented, claims for payment of government funds that are false or fraudulent;

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It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations.

If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, disgorgement, monetary fines, individual imprisonment, additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, possible exclusion from participation in federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those

actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, disgorgement, monetary fines, individual imprisonment, additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, possible exclusion from participation in federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

Our research and development, manufacturing, and administration of our drugs involve the controlled use of hazardous materials, including chemicals and radioactive materials, such as radioactive isotopes.

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For example, included in the Consolidated Appropriations Act of 2021 were several drug price reporting and transparency measures, such as a new requirement for certain Medicare plans to develop tools to display Medicare Part D prescription drug benefit information in real time and for group and health insurance issuers to report information on pharmacy benefit and drug costs to the Secretaries of the Departments of Health and Human Services, Labor and the Treasury.

Additionally, on March 11, 2021, Congress enacted the American Rescue Plan Act of 2021, which included among its provisions a sunset of the Affordable Care Act’s cap on pharmaceutical manufacturers’ rebate liability under the MDRP.

liability under the MDRP.

Under the Affordable Care Act, manufacturers’ rebate liability was capped at 100% of the average manufacturer price for a covered outpatient drug.

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Employees and Human Capital

As of December 31, 2023, we had twenty employees, all of whom were full-time employees.

Of these twenty employees, ten employees were engaged in research and development.

As of December 31, 2024, we had eleven employees, all of whom were full-time.

Of these eleven employees, six employees were engaged in research and development.

None of our employees is subject to a collective bargaining agreement or represented by a trade or labor union.

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Corporate Information

Cellectar Biosciences, Inc., formerly known as Novelos Therapeutics, Inc., was incorporated in Delaware in June 1996.

On April 8, 2011, the Company entered into a business combination with Cellectar, Inc., a privately held Wisconsin corporation that designed and developed products to detect, treat and monitor a wide variety of human cancers.

On February 11, 2014, we changed our name to Cellectar Biosciences, Inc.

Our common stock is listed on the Nasdaq Capital Market under the symbol CLRB.

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Information contained on or accessible through our website is not a part of this annual report.

Additionally, we are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K.

Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.

We will remain a smaller reporting company until the last day of the fiscal year in which (i) the market value of our common stock held by non-affiliates exceeds $250 million as of the end of that year’s second fiscal quarter, or (ii) our annual revenues exceeded $100 million during such completed fiscal year and the market value of our common stock held by non-affiliates exceeds $700 million as of the end of that year’s second fiscal quarter.

To the extent we take advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public companies difficult or impossible.

Available Information

We file with, or furnish to, the SEC reports including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports pursuant to Section 13(a) or 15(d) of the Exchange Act.

These reports are available free of charge on our corporate website (www.cellectar.com) as soon as reasonably practicable after they are electronically filed with or furnished to the SEC.

Copies of any materials we file with the SEC can be obtained at www.sec.gov.

The information provided on our website (or any other website referred to in this report) is not part of this report and is not incorporated by reference as part of this Annual Report on Form 10-K.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business