We are a reporting company and file annual,
quarterly and special reports, and other information with the SEC. Copies of the reports and other information may be read and
copied at the SEC’s Public Reference Room at 100 F Street NE, Washington, D.C. 20549. You can request copies of such documents
by writing to the SEC and paying a fee for the copying cost. You may obtain information on the operation of the Public Reference
Room by calling the SEC at 1-800-SEC-0330. The SEC maintains a web site at http://www.sec.gov that contains reports, proxy and
information statements and other information regarding registrants that file electronically with the SEC.
This prospectus is part of a registration
statement on Form S-3 that we filed with the SEC. Certain information in the registration statement has been omitted from
this prospectus in accordance with the rules and regulations of the SEC. We have also filed exhibits and schedules with the
registration statement that are excluded from this prospectus. For further information you may:
We are subject to the information and reporting
requirements of the Exchange Act and, in accordance with this law, are required to file periodic reports, proxy statements and
other information with the SEC. We make available free of charge, on or through the investor relations section of our website,
annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those
reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable
after we electronically file such material with, or furnish it to, the SEC. The information found on our website, other than as
specifically incorporated by reference in this prospectus, is not part of this prospectus.
INCORPORATION OF DOCUMENTS BY REFERENCE
The SEC allows us to “incorporate
by reference” information into this prospectus. This means that we can disclose important information to you by referring
you to another document filed separately with the SEC. The information incorporated by reference is considered to be a part of
this prospectus, except for any information that is superseded by other information that is included in this prospectus.
We incorporate by reference into this prospectus
the following document, which we have previously filed with the SEC:
In addition, all documents subsequently
filed by us pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the termination of the offering will
be deemed to be incorporated by reference into this prospectus.
You should rely only on the information
contained in this prospectus, as updated and supplemented by any prospectus supplement, or that information to which this prospectus
or any prospectus supplement has referred you by reference. We have not authorized anyone to provide you with any additional information.
Any statement contained in a document incorporated
or deemed to be incorporated by reference herein will be deemed to be modified or superseded for purposes of this prospectus to
the extent that a statement contained herein modifies or supersedes such statement. Any statement so modified or superseded will
not be deemed, except as so modified or superseded, to constitute a part of this prospectus.
You may request and obtain a copy of any
of the filings incorporated herein by reference, at no cost, by writing or telephoning us at the following address or phone number:
Cellectar Biosciences, Inc.
100 Campus Drive
Florham Park, New Jersey 07932
Attention: Chief Financial Officer (608) 441-8120
CELLECTAR BIOSCIENCES, INC.
$100,000,000
Common Stock
Preferred Stock
Warrants
Units
Subscription Rights
PROSPECTUS
August , 2020
The information in this prospectus is not complete
and may be changed. We may not sell these securities until the Registration Statement filed with the Securities and Exchange Commission
is effective. This prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in
any state where the offer or sale is not permitted.
SUBJECT TO COMPLETION,
DATED AUGUST 11, 2020
PROSPECTUS SUPPLEMENT
CELLECTAR BIOSCIENCES, INC.
$14,500,000
Common Stock
We have entered into an Equity Distribution
Agreement (“Sales Agreement”) with Oppenheimer & Co. Inc. (the “Sales Agent”) relating to shares
of our common stock offered by this prospectus. In accordance with the terms of the Sales Agreement, we may offer and sell shares
of our common stock having an aggregate offering price of up to $14,500,000 from time to time through the Sales Agent acting as
agent.
Our common stock is traded on the Nasdaq
Capital Market under the symbol CLRB. On August 7, 2020, the last reported sale price for our common stock was $1.40 per share.
The aggregate market value of our outstanding common stock held by non-affiliates, or public float, as of the date of this prospectus
is approximately $43.9 million based on 26,424,893 shares of outstanding common stock held by non-affiliates, and a per share price
of $1.66, which was the last reported sale price of our common stock on the Nasdaq Capital Market on July 30, 2020 (a
date within 60 days of the date hereof). Pursuant to General Instruction I.B.6 of Form S-3, in no event will we sell securities
registered on the registration statement of which this prospectus is a part in a public primary offering with a value exceeding
more than one-third of our public float in any 12-month period if our public float, measured in accordance with such instruction,
remains below $75.0 million. As of the date hereof, we have not offered any securities pursuant to General Instruction I.B.6 of
Form S-3 during the 12 calendar months prior to and including the date of this prospectus.
Sales of our common stock, if any, under
this prospectus may be made in sales deemed to be “at the market offerings” as defined in Rule 415 promulgated
under the Securities Act of 1933, as amended (the “Securities Act”), or in privately negotiated transactions. The Sales
Agent is not required to sell any specific number or dollar amount of securities, but will act as a sales agent, using commercially
reasonable efforts consistent with its normal trading and sales practices, on mutually agreed terms between the Sales Agent and
us. There is no arrangement for funds to be received in any escrow, trust or similar arrangement.
The compensation to the Sales Agent for
sales of common stock sold pursuant to the Sales Agreement will be an amount equal to 3.0% of the gross proceeds of any shares
of common stock sold under the Sales Agreement. See “Plan of Distribution” of this Prospectus for additional information
regarding the Sales Agent’s compensation. In connection with the sale of the common stock on our behalf, the Sales Agent
will be deemed to be an “underwriter” within the meaning of the Securities Act and the compensation of the Sales Agent
will be deemed to be underwriting commissions or discounts. We have also agreed to provide indemnification and contribution to
the Sales Agent with respect to certain liabilities, including liabilities under the Securities Act and the Exchange Act of 1934,
as amended (Exchange Act).
INVESTING IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK.
YOU SHOULD REVIEW CAREFULLY THE RISKS AND UNCERTAINTIES DESCRIBED UNDER THE HEADING “RISK FACTORS” OF THIS PROSPECTUS,
AND UNDER SIMILAR HEADINGS IN THE DOCUMENTS THAT ARE INCORPORATED BY REFERENCE INTO THIS PROSPECTUS AND THE ACCOMPANYING PROSPECTUS.
Neither the
Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined
if this prospectus and the accompanying prospectus are truthful or complete. Any representation to the contrary is a criminal offense.
Oppenheimer &
Co.
The date of this
prospectus is , 2020.
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
This
prospectus relates to part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission,
or SEC, utilizing a “shelf” registration process. Under this shelf registration process, we may sell any combination
of the securities described in our base prospectus included in the shelf registration statement in one or more offerings up to
a total aggregate offering price of $100,000,000. The $14,500,000 shares of common stock that may be offered, issued and sold under
this prospectus is included in the $100,000,000 of securities that may be offered, issued and sold by us pursuant to our shelf
registration statement.
This
prospectus relates to the offering of shares of our common stock. Before buying any of the common stock that we are offering, we
urge you to carefully read this prospectus, together with the information incorporated by reference as described under the headings
“Where You Can Find Additional Information” and “Incorporation of Certain Information by Reference” in
this prospectus. These documents contain important information that you should consider when making your investment decision.
This
document is in two parts. The first part is this prospectus supplement, which describes the specific terms of this offering of
our common stock and also adds, updates and changes information contained in the accompanying prospectus and the documents incorporated
by reference. The second part is the accompanying base prospectus, which gives more general information, some of which may not
apply to this offering of our common stock. To the extent the information contained in this prospectus supplement differs or varies
from the information contained in the accompanying prospectus or any document filed prior to the date of this prospectus supplement
and incorporated by reference, the information in this prospectus supplement will control. Generally, when we refer to this “prospectus,”
we are referring to both documents combined, together with any free writing prospectus that we have authorized for use in connection
with this offering.
You should rely only on the information
contained in or incorporated by reference in this prospectus and in any free writing prospectus that we have authorized for use
in connection with this offering. We have not, and the Sales Agent has not, authorized anyone to provide you with different information.
If anyone provides you with different or inconsistent information, you should not rely on it. We are not, and the Sales Agent is
not, making an offer to sell these securities in any jurisdiction where the offer or sale is not permitted. You should assume that
the information appearing in this prospectus, the documents incorporated by reference in this prospectus, and in any free writing
prospectus that we have authorized for use in connection with this offering, is accurate only as of the date of those respective
documents. Our business, financial condition, results of operations and prospects may have changed since those dates. You should
read this prospectus, the documents incorporated by reference in this prospectus, and any free writing prospectus that we have
authorized for use in connection with this offering, in their entirety before making an investment decision.
The
representations, warranties, and covenants made by us in any agreement that is filed as an exhibit to any document that is incorporated
by reference into this prospectus supplement or the accompanying prospectus were made solely for the benefit of the parties to
such agreement, including, in some cases, for the purpose of allocating risk among the parties to such agreements, and should not
be deemed to be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate
only as of the date when made. Accordingly, such representations, warranties and covenants should not be relied on as accurately
representing the current state of our affairs.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This prospectus, including the documents
that we incorporate by reference, contains forward-looking statements within the meaning of Section 27A of the Securities
Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”). Examples of our forward-looking statements include:
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our current views with respect to our business strategy, business plan and research and development activities;
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the impact of the COVID-19 pandemic on our business, employees, operating results, ability to obtain additional funding, product development programs, research and development programs, suppliers and third-party manufacturers;
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the progress of our product development programs, including clinical testing and the timing of commencement and results thereof;
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our projected operating results, including research and development expenses;
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our ability to continue development plans for CLR 131, CLR 1800 series, CLR 1900 series, CLR 2000 series, CLR 2100 series, CLR 2200 series and CLR 12120;
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our ability to continue development plans for our Phospholipid Drug Conjugates (PDC)™;
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our ability to maintain orphan drug designation in the U.S. for CLR 131 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;
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any disruptions at our sole supplier of CLR 131;
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our ability to pursue strategic alternatives;
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our ability to advance our technologies into product candidates;
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our enhancement and consumption of current resources along with ability to obtain additional funding;
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our current view regarding general economic and market conditions, including our competitive strengths;
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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, including the COVID-19 pandemic, cyber-attacks and general instability;
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assumptions underlying any of the foregoing; and
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any other statements that address events or developments that we intend or believe will or may occur in the future.
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In some cases, you can identify forward-looking
statements by terminology such as “expects,” “anticipates,” “intends,” “estimates,”
“plans,” “believes,” “seeks,” “may,” “should,” “could”
or the negative of such terms or other similar expressions. Accordingly, these statements involve estimates, assumptions and uncertainties
that could cause actual results to differ materially from those expressed in them. Forward-looking statements also involve risks
and uncertainties, many of which are beyond our control. Any forward-looking statements are qualified in their entirety by reference
to the factors discussed throughout this prospectus.
You should read this prospectus and the
documents that we reference herein and therein and have filed as exhibits to the registration statement, of which this prospectus
is part, completely and with the understanding that our actual future results may be materially different from what we expect.
You should assume that the information appearing in this prospectus is accurate only as of the date on the front cover of this
prospectus or such prospectus supplement. Because the risk factors referred to above could cause actual results or outcomes to
differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue
reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made,
and we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which
the statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not
possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or
the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in
any forward-looking statements. We qualify all of the information presented in this prospectus and any accompanying prospectus
supplement, and particularly our forward-looking statements, by these cautionary statements.
SUMMARY
This summary highlights information
contained elsewhere in this prospectus and does not contain all of the information that you should consider in making your investment
decision. Before investing in our securities, you should carefully read this entire prospectus, including the documents to which
we have referred you under the headings “Where You Can Find More Information” and “Incorporation of Documents
by Reference” and the information set forth under the headings “Risk Factors” and “Management’s Discussion
and Analysis of Financial Condition and Results of Operations,” in each case, included elsewhere in this prospectus or incorporated
herein by reference.
Overview
We are a clinical stage biopharmaceutical
company focused on the discovery, development and commercialization of drugs for the treatment of cancer. We are developing proprietary
drugs independently and through research and development collaborations. Our core objective is to leverage our proprietary phospholipid
drug conjugate™ (PDC™) delivery platform to develop PDCs that are designed to specifically target cancer cells, and
deliver improved efficacy and better safety as a result of fewer off-target effects. 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. The COVID-19 pandemic has created uncertainties in the expected timelines
for clinical stage biopharmaceutical companies such as us, and because of such uncertainties, it is difficult for us to accurately
predict expected outcomes at this time. We have not yet experienced any significant impacts as a result of the pandemic and have
continued to enroll patients in our clinical trials. However, COVID-19 may impact our future ability to recruit patients for clinical
trials, obtain adequate supply of CLR 131 and obtain additional financing.
CLR 131 and PDC Platform
Our lead PDC therapeutic, CLR 131 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 CLR 131 from many traditional on-market treatment options. CLR 131 is the company’s
lead product candidate and is currently being evaluated in a Phase 2 study in relapsed/refractory (r/r) b-cell malignancies, including
multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma/Waldenstrom’s
macroglobulinemia (LPL/WM), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL).
CLR 131 is also being evaluated in a Phase 1 dose escalation study in pediatric solid tumors and lymphoma. The U.S. Food and Drug
Administration (“FDA”) granted CLR 131 Fast Track Designation for both r/r MM and r/r DLBCL and Orphan Drug Designation
(ODD) of MM, LPL/WM, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. CLR 131 was also granted Rare Pediatric
Disease Designation (RPDD) for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Most recently,
the European Commission granted an ODD for r/r MM.
Our product pipeline also includes one
preclinical PDC chemotherapeutic program (CLR 1900) and several partnered PDC assets. The CLR 1900 Series is being targeted
for solid tumors with a payload that inhibits mitosis (cell division) a validated pathway for treating cancers.
We have leveraged our PDC platform to establish
four collaborations featuring five unique payloads and mechanisms of action. Through research and development collaborations, our
strategy is to generate near-term capital, supplement internal resources, gain access to novel molecules or payloads, accelerate
product candidate development and broaden our proprietary and partnered product pipelines.
Our PDC platform provides selective delivery
of a diverse range of oncologic payloads to cancerous cells, whether a hematologic cancer or solid tumor, a primary tumor, or a
metastatic tumor and cancer stem cells. The PDC platform’s mechanism of entry does not rely upon specific cell surface epitopes
or antigens as are required by other targeted delivery platforms. Our PDC platform takes advantage of a metabolic pathway utilized
by all tumor cell types in all stages of the tumor cycle. Tumor cells modify specific regions on the cell surface as a result of
the utilization of this metabolic pathway. Our PDCs bind to these regions and directly enter the intracellular compartment. This
mechanism allows the PDC molecules to accumulate over time, which enhances drug efficacy, and to avoid the specialized highly acidic
cellular compartment known as lysosomes, which allows a PDC to deliver molecules that previously could not be delivered. Additionally,
molecules targeting specific cell surface epitopes face challenges in completely eliminating a tumor because the targeted antigens
are limited in the total number on the cell surface, have longer cycling time from internalization to being present on the cell
surface again and available for binding and are not present on all of the tumor cells in any cancer. This means a subpopulation
of tumor cells always exist that cannot be targeted by therapies targeting specific surface epitopes. In addition to the benefits
provided by the mechanism of entry, PDCs offer the ability to conjugate payload molecules in numerous ways, thereby increasing
the types of molecules selectively delivered via the PDC.
The PDC platform features include the capacity
to link with almost any molecule, provide a significant increase in targeted oncologic payload delivery and the ability to target
all types of tumor cells. As a result, we believe that we can generate 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.
We employ a drug discovery and development
approach that allows us to efficiently design, research and advance drug candidates. Our iterative process allows us to rapidly
and systematically produce multiple generations of incrementally improved targeted drug candidates.
In June 2020, the European Medicines Agency
(EMA) granted us Small and Medium-Sized Enterprise status by the EMA’s Micro, Small and Medium-sized Enterprise office. 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. 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.
A description of our PDC product candidates
follows:
Clinical Pipeline
Our lead PDC therapeutic, CLR 131 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 CLR 131 from many traditional on-market treatments and treatments in development. CLR 131 is
currently being evaluated in a Phase 2 study in r/r B-cell lymphomas, and two Phase 1 dose-escalating clinical studies, one in
r/r MM and one in r/r pediatric solid tumors and lymphoma. The initial Investigational New Drug (IND) application was accepted
by the FDA in March 2014 with multiple INDs submitted since that time. Initiated in March 2017, the primary goal of the
Phase 2 study is to assess the compound’s efficacy in a broad range of hematologic cancers. The Phase 1 study is designed
to assess the compound’s safety and tolerability in patients with r/r MM (to determine maximum tolerated dose) and was initiated
in April 2015. The FDA previously accepted our IND application for a Phase 1 open-label, dose escalating study to evaluate
the safety and tolerability of a single intravenous administration of CLR 131 in up to 30 children and adolescents with cancers
including neuroblastoma, sarcomas, lymphomas (including Hodgkin’s lymphoma) and malignant brain tumors. This study was initiated
during the first quarter of 2019. These cancer types were selected for clinical, regulatory and commercial rationales, including
the radiosensitive nature and continued unmet medical need in the r/r setting, and the rare disease determinations made by the
FDA based upon the current definition within the Orphan Drug Act.
In December 2014, the FDA granted ODD for CLR
131 for the treatment of MM. Multiple myeloma is an incurable cancer of the plasma cells and is the second most common form of
hematologic cancers. In 2018, the FDA granted ODD and RPDD for CLR 131 for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s
sarcoma and osteosarcoma. The FDA may award priority review vouchers to sponsors of rare pediatric disease products that meet its
specified criteria. The key criteria to receiving a priority review voucher is that the disease being treated is life-threatening
and that it primarily effects individuals under the age of 18. Under this program, a sponsor who receives an approval for a drug
or biologic for a rare pediatric disease can receive a priority review voucher that can be redeemed to receive a priority review
of a subsequent marketing application for a different product. Additionally, these priority review vouchers can be exchanged or
sold to other companies for them to use the voucher. In May 2019, the FDA granted Fast Track designation for CLR 131 for the
treatment of multiple myeloma in July 2019 for the treatment of DLBCL, in September, CLR 131 received Orphan Drug Designation
from the European Union for Multiple Myeloma, and in January 2020, CLR 131 the FDA granted Orphan Drug Designation for CLR
131 in lymphoplasmacytic lymphoma (LPL).
Phase 2 Study in Patients with r/r select B-cell
Malignancies
In February 2020, we announced positive data
from our Phase 2 CLOVER-1 study in patients with relapsed/refractory B-cell lymphomas. Relapsed/Refractory MM and non-Hodgkin lymphoma
(NHL) patients were treated with three different doses (<50mCi, ~50mCi and ~75mCi total body dose (TBD). The <50mCi total
body dose was a deliberately planned sub-therapeutic dose. CLR 131 achieved the primary endpoint for the study. Patients with r/r
MM who received the highest dose of CLR 131 showed a 42.8% overall response rate (ORR). Those who received ~50mCi TBD had a 26.3%
ORR with a combined rate of 34.5% ORR (n=33) while maintaining a well-tolerated safety profile. Patients in the studies were elderly
with a median age of 70, and heavily pre-treated, with a median of five prior lines of treatment (range: 3 to 17), which included
immunomodulatory drugs, proteasome inhibitors and CD38 antibodies for the majority of patients. Additionally, a majority of the
patients (53%) were quad refractory or greater and 44% of all treated multiple myeloma patients were triple class refractory. 100%
of all evaluable patients (n=43) achieved clinical benefit (primary outcome measure) as defined by having stable disease or better.
85.7% of multiple myeloma patients receiving the higher total body dose levels of CLR 131 experienced tumor reduction. The 75mCi
TBD demonstrated positive activity in both high-risk patients and triple class refractory patients with a 50% and 33% ORR, respectively.
Patients with r/r NHL who received ~50mCi TBD and
the ~75mCi TBD had a 42% and 43% ORR, respectively and a combined rate of 42%. These patients were also heavily pre-treated, having
a median of three prior lines of treatment (range, 1 to 9) with the majority of patients being refractory to rituximab and/or ibrutinib.
The patients had a median age of 70 with a range of 51 to 86. All patients had bone marrow involvement with an average of 23%.
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 complete response (CR), which continues at nearly 24 months post-treatment. The ORR for
CLL/SLL/MZL patients was 33%. Current data from our Phase 2 CLOVER-1 clinical study show that four LPL/WM patients demonstrated
100% ORR with one patient achieving a CR which continues at nearly 27 months post-treatment. This may represent an important improvement
in the treatment of relapsed/refractory LPL/WM as we believe no approved or late-stage development treatments for second- and third-line
patients have reported a CR. LPL/WM is a rare, indolent and incurable form of NHL that is composed of a patient population in
need of new and better treatment options.
The most frequently reported adverse events in r/r
MM patients were cytopenias, which followed a predictable course and timeline. The frequency of adverse events have not increased
as doses were increased and the profile of cytopenias remains consistent. Importantly, these cytopenias have had a predictable
pattern to initiation, nadir and recovery and are treatable. The most common grade ≥3 events at the highest dose (75mCi TBD)
were hematologic toxicities including thrombocytopenia (65%), neutropenia (41%), leukopenia (30%), anemia (24%) and lymphopenia
(35%). No patients experienced cardiotoxicities, neurological toxicities, infusion site reactions, peripheral neuropathy, allergic
reactions, cytokine release syndrome, keratopathy, renal toxicities, or changes in liver enzymes. The safety and tolerability profile
in patients with r/r NHL was similar to r/r MM patients except for fewer cytopenias of any grade. Based upon CLR 131 being well
tolerated across all dose groups and the profound observed response rate, especially in difficult to treat patients such as high
risk and triple class refractory or penta-refractory, and corroborating data showing the potential to further improve upon current
ORRs and durability of those responses, the study has been expanded to test a two-cycle dosing optimization regimen of CLR 131.
In July 2016, we were awarded a $2,000,000 National
Cancer Institute (NCI) Fast-Track Small Business Innovation Research grant to further advance the clinical development of CLR 131.
The funds are supporting the Phase 2 study initiated in March 2017 to define the clinical benefits of CLR 131 in r/r MM and
other niche hematologic malignancies with unmet clinical need. These niche hematologic malignancies include Chronic Lymphocytic
Leukemia, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma, Lymphoplasmacytic Lymphoma and DLBCL. The study is being conducted
in approximately 10 U.S. cancer centers in patients with orphan-designated relapse or refractory hematologic cancers. The study’s
primary endpoint is clinical benefit response (CBR), with additional endpoints of ORR, progression free survival (PFS), median
Overall Survival (mOS) and other markers of efficacy following a single 25.0 mCi/m2 dose of CLR 131, with the option for a second
25.0 mCi/m2 dose approximately 75-180 days later. Based on the performance results from Cohort 5 of our Phase 1 study in patients
with r/r MM, reviewed below, we have modified the dosing regimen of this study to a fractionated dose of 15.625 mCi/m2 administered
on day 1 and day 8.
Phase 1 Study in Patients with r/r Multiple Myeloma
In February 2020, we announced the successful
completion of our Phase 1 dose escalation study. Data from the study demonstrated that CLR 131 was safe and tolerated at total
body dose of approximately 90mCi in r/r MM, The Phase 1 multicenter, open-label, dose-escalation study was designed to evaluate
the safety and tolerability of CLR 131 administered as a 30-minute I.V. infusion, either as a single bolus dose or as two fractionated
doses. The r/r multiple myeloma patients in this study received single cycle doses ranging from approximately 20mCi to 90mCi total
body dose. To date, an independent Data Monitoring Committee determined that all doses have been safe and well-tolerated by patients.
CLR 131 in combination with dexamethasone is currently
under investigation in adult patients with r/r MM. Patients must have been refractory to or relapsed from at least one proteasome
inhibitor and at least one immunomodulatory agent. The clinical study is a standard three-plus-three dose escalation safety study
to determine the maximum tolerable dose. Multiple myeloma is an incurable cancer of the plasma cells and is the second most common
form of hematologic cancers. Secondary objectives include the evaluation of therapeutic activity by assessing surrogate efficacy
markers, which include M protein, free light chain (FLC), PFS and OS. All patients have been heavily pretreated with an average
of five prior lines of therapy. CLR 131 was deemed by an Independent Data Monitoring Committee (IDMC) to be safe and tolerable
up to its planned maximum single, bolus dose of 31.25 mCi/m2. The four single dose cohorts examined were: 12.5 mCi/m2 (~25mCi TBD),
18.75 mCi/m2 (~37.5mCi TBD), 25 mCi/m2(~50mCi TBD), and 31.25 mCi/m2(~62.5mCi TBD), all in combination with low dose dexamethasone
(40 mg weekly). Of the five patients in the first cohort, four achieved stable disease and one patient progressed at Day 15 after
administration and was taken off the study. Of the five patients admitted to the second cohort, all five achieved stable disease
however one patient progressed at Day 41 after administration and was taken off the study. Four patients were enrolled to the third
cohort and all achieved stable disease. In September 2017, we announced results for cohort 4, showing that a single infusion
up to 30-minutes of 31.25mCi/m2 of CLR 131 was safe and tolerated by the three patients in the cohort. Additionally, all three
patients experienced CBR with one patient achieving a partial response (PR). We use the International Myeloma Working Group (IMWG)
definitions of response, which involve monitoring the surrogate markers of efficacy, M protein and FLC. The IMWG defines a PR as
a greater than or equal to 50% decrease in FLC levels (for patients in whom M protein is unmeasurable) or 50% or greater decrease
in M protein. The patient experiencing a PR had an 82% reduction in FLC. This patient did not produce M protein, had received seven
prior lines of treatment including radiation, stem cell transplantation and multiple triple combination treatments including one
with daratumumab that was not tolerated. One patient experiencing stable disease attained a 44% reduction in M protein. In January 2019,
we announced that the pooled mOS data from the first four cohorts was 22.0 months. In late 2018, we modified this study to evaluate
a fractionated dosing strategy to potentially increase efficacy and decrease adverse events.
Following the determination that all prior dosing
cohorts were safe and tolerated, we initiated a cohort 7 utilizing a 40mCi/m2 fractionated dose administered 20mCi/m2 (~40mCi TBD)
on days 1 and day 8. Cohort 7 was the highest pre-planned dose cohort and subjects have completed the evaluation period. Final
study report and study close-out will be completed later this year.
In May 2019, we announced that the FDA granted
Fast Track Designation for CLR 131 in fourth line or later r/r MM. CLR 131 is our small-molecule radiotherapeutic PDC designed
to deliver cytotoxic radiation directly and selectively to cancer cells and cancer stem cells. It is currently being evaluated
in our ongoing CLOVER-1 Phase 2 clinical study in patients with relapsed or refractory multiple myeloma and other select B-cell
lymphomas.
Phase 1 Study in r/r Pediatric Patients with select
Solid tumors, Lymphomas and Malignant Brain Tumors
In December 2017 the Division of Oncology at
the FDA accepted our IND and study design for the Phase 1 study of CLR 131 in children and adolescents with select rare and orphan
designated cancers. This study was initiated during the first quarter of 2019. In December 2017, we filed an IND application
for r/r pediatric patients with select solid tumors, lymphomas and malignant brain tumors. The Phase 1 clinical study of CLR 131
is an open-label, sequential-group, dose-escalation study evaluating the safety and tolerability of intravenous administration
of CLR 131 in up to 30 children and adolescents with cancers including neuroblastoma, sarcomas, lymphomas (including Hodgkin’s
lymphoma) and malignant brain tumors. Secondary objectives of the study are to identify the recommended Phase 2 dose of CLR 131
and to determine preliminary antitumor activity (treatment response) of CLR 131 in children and adolescents. In 2018, the FDA granted
OD and RPDD for CLR 131 for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Should any
of these indications reach approval, the 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.
Phase 1 Study in r/r Head and Neck Cancer
In August 2016, the University of Wisconsin Carbone
Cancer Center (“UWCCC”) was awarded a five-year Specialized Programs of Research Excellence (“SPORE”) grant
of $12,000,000 from the National Cancer Institute and the National Institute of Dental and Craniofacial Research to improve treatments
and outcomes for head and neck cancer, HNC, patients. HNC is the sixth most common cancer across the world with approximately 56,000
new patients diagnosed every year in the U.S. As a key component of this grant, the UWCCC researchers completed testing of CLR
131 in various animal HNC models and initiated the first human clinical trial enrolling up to 30 patients combining CLR 131 and
external beam radiation with recurrent HNC in Q4 2019. This clinical trial was suspended due to the
COVID-19 pandemic but has now been reopened for enrollment.
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:
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CLR 1800 Series was a collaborative PDC program with Pierre Fabre that expired in January 2019. The program has been successful in demonstrating improved tolerability and efficacy in multiple animal models. The newly developed PDCs may provide enhanced therapeutic indices to otherwise highly potent, nontargeted payloads through the targeted delivery of the chemotherapeutic payload to cancer cells via our proprietary phospholipid ether delivery platform. The CLR 1800 Series remains under evaluation by us as a number of PDC molecules have the potential to be progressed toward and into IND enabling studies.
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CLR 1900 Series is an internally developed proprietary PDC program leveraging a novel small molecule cytotoxic compound as the payload. The payload inhibits mitosis (cell division) and targets a key pathway required to inhibit rapidly dividing cells that results in apoptosis. We believe that this program could produce a product candidate targeted to select solid tumors. Currently, the program is in early preclinical development and if we elect to progress any molecules further, we will select preferred candidates.
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CLR 2000 Series is a collaborative PDC program with Avicenna Oncology, or Avicenna, that we entered into in July 2017. Avicenna is a developer of antibody drug conjugates (“ADCs”). The objective of the research collaboration is to design and develop a series of PDCs utilizing Avicenna’s proprietary cytotoxic payload. Although Avicenna is a developer of ADCs, this collaboration was sought as a means to overcome many of the challenges associated with ADCs, including those associated with the targeting of specific cell surface epitopes. The CLR 2000 Series has demonstrated improved safety, efficacy and tissue distribution with the cytotoxic payload in animal models. A candidate molecule and a back-up have been selected for further advancement.
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CLR 2100 and 2200 Series are collaborative PDC programs with Onconova Therapeutics, Inc., or Onconova, that we entered into in September 2017. Onconova is a biotechnology company specializing in the discovery and development of novel small molecule cancer therapies. The collaboration is structured such that we will design and develop a series of PDCs utilizing different small molecules that Onconova was developing as payloads with the intent to show improved targeting and specificity to the tumor. At least one of the molecules was taken into Phase 1 clinical studies previously by Onconova. We would own all new intellectual property associated with the design of the new PDCs, and both companies will have the option to advance compounds.
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CLR 12120 Series is a collaborative PDC program with Orano Med for the development of novel PDCs utilizing Orano Med’s unique alpha emitter, lead 212 conjugated to our phospholipid ether; the companies intend to evaluate the new PDCs in up to three oncology indications. Currently this series has shown efficacy in the first two animal models tested.
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Our shares are listed on the Nasdaq Capital
Market under the symbol CLRB. Before August 15, 2014, our shares were quoted on the OTCQX marketplace, and prior to February 12,
2014, they were quoted under the symbol NVLT.
Key Risks and Uncertainties
We are subject to numerous risks and uncertainties,
including the following:
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Our operations and financial condition may be adversely impacted by the COVID-19 pandemic.
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We will require additional capital in order to continue our operations and may have difficulty raising additional capital.
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We are a clinical-stage company with a going concern qualification to our financial statements and a history of losses, and
we can provide no assurance as to our future operating results.
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We rely on a collaborative outsourced business model, and disruptions with these third-party collaborators may impede our ability
to gain FDA approval and delay or impair commercialization of any products.
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We will require additional capital in order to continue our operations and may have difficulty raising additional capital.
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We rely on a small number of key personnel who may terminate their employment with us at any time, and our success will depend
on our ability to hire additional qualified personnel.
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We cannot assure the successful development and commercialization of our compounds in development.
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Our proposed products and their potential applications are in an early stage of clinical and manufacturing/process development
and face a variety of risks and uncertainties.
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Failure to complete the development of our technologies, to obtain government approvals, including required FDA approvals,
or comply with ongoing governmental regulations could prevent, delay or limit introduction or sale of proposed products and result
in failure to achieve revenues or maintain our ongoing business.
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Clinical studies involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials
may not be predictive of future trial results.
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We may be required to suspend or discontinue clinical studies due to unexpected side effects or other safety risks that could
preclude approval of our product candidates.
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Controls we or our third-party collaborators have in place to ensure compliance with all applicable laws and regulations may
not be effective.
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We expect to rely on our patents as well as specialized regulatory designations such as orphan drug classification for our
product candidates, but regulatory drug designations may not confer marketing exclusivity or other expected commercial benefits.
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The FDA has granted rare pediatric disease designation, RPDD, to CLR 131 for treatment of neuroblastoma and rhabdomyosarcoma;
however, we may not be able to realize any value from such designation.
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We are exposed to product, clinical and preclinical liability risks that could create a substantial financial burden should
we be sued.
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Acceptance of our products in the marketplace is uncertain and failure to achieve market acceptance will prevent or delay our
ability to generate revenues.
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The market for our proposed products is rapidly changing and competitive, and new therapeutics, drugs and treatments that may
be developed by others could impair our ability to develop our business or become competitive.
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We may face litigation from third parties claiming that our products infringe on their intellectual property rights, particularly
because there is often substantial uncertainty about the validity and breadth of medical patents.
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If we are unable to adequately protect or enforce our rights to intellectual property or to secure rights to third-party patents,
we may lose valuable rights, experience reduced market share, assuming any, or incur costly litigation to protect our intellectual
property rights.
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Conflicts, military actions, terrorist attacks, natural disasters. public health crises, including the occurrence of a contagious
disease or illness, such as the COVID-19 coronavirus, cyber-attacks and general instability could adversely affect our business.
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Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary
information and may not adequately protect our intellectual property, which could limit our ability to compete.
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We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
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Due to continued changes in marketing, sales and distribution, we may be unsuccessful in our efforts to sell our proposed products,
develop a direct sales organization, or enter into relationships with third parties.
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If we are unable to convince physicians of the benefits of our intended products, we may incur delays or additional expense
in our attempt to establish market acceptance.
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If users of our products are unable to obtain adequate reimbursement from third-party payors, or if additional healthcare reform
measures are adopted, it could hinder or prevent the commercial success of our product candidates.
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Our business and operations may be materially, adversely affected in the event of computer system failures or security breaches.
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Failure to maintain effective internal controls could adversely affect our ability to meet our reporting requirements.
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We have in the past received notices from Nasdaq of noncompliance with its listing rules, and delisting with Nasdaq could impact
the price of our common stock and our ability to raise funds.
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Our stock price has experienced price fluctuations.
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Our common stock could be further diluted as the result of the issuance of additional shares of common stock, convertible securities,
warrants or options.
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Provisions of our certificate of incorporation, by-laws, and Delaware law may make an acquisition of us or a change in our
management more difficult.
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We have not paid dividends in the past and do not expect to pay dividends for the foreseeable future. Any return on investment
may be limited to the value of our common stock.
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Our management team will have immediate and broad discretion over the use of the net proceeds from this offering, and you may
not agree with our use of the net proceeds.
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You will experience immediate and substantial dilution as a result of this offering and may experience additional dilution
in the future.
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You may experience future dilution as a result of future equity offerings.
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more information regarding the material
risks and uncertainties we face, please see “Risk Factors” beginning on page S-14 of this prospectus.
Corporate Information
Our principal executive offices are located
at 100 Campus Drive, Florham Park, New Jersey 07932 and the telephone number of our principal executive offices is (608) 441-8120.
We maintain a website at www.cellectar.com. The information included or referred to on, or accessible through, our website does
not constitute part of, and is not incorporated by reference into, this prospectus.
The Offering
The following is a brief summary of some
of the terms of the offering and is qualified in its entirety by reference to the more detailed information appearing elsewhere
in this prospectus. For a more complete description of the terms of our common stock, see the “Description of the Securities
We Are Offering” section in this prospectus.
Common stock offered by us:
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Shares of our common stock having an aggregate offering price of up to $14,500,000; the specific amount of the offering shall be at the Company’s sole discretion.
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Manner of Offering:
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“At the market offering” that may be made from time to time through our agent, the Sales Agent. See “Plan of Distribution.”
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Use of Proceeds:
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We expect to use the net proceeds received from this offering to fund our research and development activities and for general corporate purposes. For a more complete description of our anticipated use of proceeds from this offering, see “Use of Proceeds.”
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Risk Factors:
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See “Risk Factors” beginning on page S-14 and the other information included in this prospectus for a discussion of factors you should carefully consider before deciding whether to purchase our securities.
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Nasdaq symbol for our common stock:
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CLRB
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RISK FACTORS
An investment in our securities involves
a high degree of risk. Prior to making a decision about investing in our securities, prospective investors should consider carefully
all of the information included and incorporated by reference or deemed to be incorporated by reference in this prospectus, including
the risk factors incorporated by reference herein from our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as updated by annual, quarterly and other reports and documents we file with the SEC after the date of this prospectus and
that are incorporated by reference herein or in the applicable prospectus supplement. Each of these risk factors could have a material
adverse effect on our business, results of operations, financial position or cash flows, which may result in the loss of all or
part of your investment. For more information, see “Where You Can Find Additional Information” and “Incorporation
of Certain Information by Reference.”
In addition, you should carefully consider
the following risks related to this offering, together with the other information about these risks contained in this prospectus,
as well as the other information contained in this prospectus generally, before deciding to buy our securities. Any of the risks
we describe below could adversely affect our business, financial condition, operating results, or prospects. The market price for
our securities could decline if one or more of these risks and uncertainties develop into actual events and you could lose all
or part of your investment. Additional risks and uncertainties that we do not yet know of, or that we currently think are immaterial,
may also impair our business operations.
RISKS RELATED TO THIS OFFERING
We have broad discretion to determine
how to use the proceeds raised in this offering, and we may not use the proceeds effectively.
The net proceeds from this offering will
be immediately available to our management to use at its discretion. We currently intend to use the net proceeds from this offering
to fund our research and development activities, general corporate purposes, and possibly for acquisitions of other companies,
products or technologies, although no such acquisitions are currently contemplated. See “Use of Proceeds.” We have
not allocated specific amounts of the net proceeds from this offering for any of the foregoing purposes. Accordingly, our management
will have significant discretion and flexibility in applying the net proceeds of this offering. You will be relying on the judgment
of our management with regard to the use of these net proceeds, and you will not have the opportunity, as part of your investment
decision, to assess whether the proceeds are being used appropriately. It is possible that the net proceeds will be invested in
a way that does not yield a favorable, or any, return for us or our stockholders. The failure of our management to use such funds
effectively could have a material adverse effect on our business, prospects, financial condition and results of operation.
Sales of a substantial number of
our common stock, or the perception that such sales might occur, could adversely affect the trading price of our common stock.
We may issue up to $14,500,000 shares of
common stock from time to time in this offering. Sales of a substantial number of our common stock, or the perception that such
sales might occur, could adversely affect the trading price of our common stock. We cannot predict the effect, if any, that market
sales of those common stock or the availability of those shares of common stock for sale will have on the market price of our common
stock. In addition, the market price of our common stock could fall as a result of resales of any of these common stock due to
an increased number of shares available for sale in the market.
You may experience immediate dilution
in the book value per share of the common stock you purchase.
Because the price per share of our
common stock being offered may be substantially higher than the book value per share of our common stock, you may experience
substantial dilution in the net tangible book value of the common stock you purchase in this offering. Assuming that an
aggregate of 10,357,143 common stock are sold at a price of $1.40 per share pursuant to this prospectus, which was the last
reported sale price of our common stock on the Nasdaq Capital Market on August 7, 2020, and based on the net tangible book
value of the common stock of $0.78 per share as of June 30, 2020, if you purchase common stock in this offering, you will
experience dilution of $0.45 per share in the net tangible book value of the common stock.
You may experience future dilution as a result
of future equity offerings.
In order to raise additional capital, in
the future we may offer additional shares of our common stock or other securities convertible into or exchangeable for our common
stock at prices that may not be the same as the price in this offering. We may sell shares or other securities in any other offering
at a price that is less than the price paid by investors in this offering, and investors purchasing shares or other securities
in the future could have rights superior to existing stockholders. The price at which we sell additional shares of our common stock,
or securities convertible or exchangeable into common stock, in future transactions may be higher or lower than the price paid
by investors in this offering.
It is not possible to predict the
actual number of shares we will sell under the Sales Agreement or the gross proceeds resulting from those sales.
Subject to certain limitations in the Sales
Agreement and compliance with applicable law, we have the discretion to deliver a placement notice to the Sales Agent at any time
throughout the term of the Sales Agreement. The number of shares that are sold through the Sales Agent after delivering a placement
notice will fluctuate based on a number of factors, including the market price of our common stock during the sales period, the
limits we set with the Sales Agent in any applicable placement notice, and the demand for our common stock during the sales period.
Because the price per share of each share sold will fluctuate during the sales period, it is not currently possible to predict
the number of shares that will be sold or the gross proceeds to be raised in connection with those sales.
Our common stock offered hereby will
be sold in “at the market offerings,” and investors who buy shares at different times will likely pay different prices.
Investors who purchase shares in this offering
at different times will likely pay different prices, and so may experience different levels of dilution and different outcomes
in their investment results. We will have discretion, subject to market demand, to vary the timing, prices, and numbers of shares
sold in this offering. In addition, there is no minimum or maximum sales price for shares to be sold in this offering. Investors
may experience a decline in the value of the shares they purchase in this offering as a result of sales made at prices lower than
the prices they paid.
USE OF PROCEEDS
We may issue and sell shares of our common
stock having aggregate sales proceeds of up to $14,500,000 from time to time. Because there is no minimum offering amount required
as a condition to close this offering, the actual total public offering amount, commissions and proceeds to us, if any, are not
determinable at this time. There can be no assurance that we will sell any shares under or fully utilize the Sales Agreement with
the Sales Agent as a source of financing.
We expect to use any proceeds received
from this offering as follows:
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research and development activities, including the further development of CLR 131, and the research advancement of our PDC platform, including product candidates, CLR 1700, CLR 1800, CLR 1900, CLR 2000, CLR 2100, CLR 2200 series and CLR 12120.
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general corporate purposes, such as human resource acquisition to support organizational priorities, general and administrative expenses, capital expenditures, working capital, repayment of debt, prosecution and maintenance of our intellectual property, and the potential investment in technologies, products or collaborations that complement our business.
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Even if we sell all of the securities subject
to this offering, we will still need to obtain additional financing in the future in order to fully fund these product candidates
through the regulatory approval process. We may seek such additional financing through public or private equity or debt offerings
or other sources, including collaborative or other arrangements with corporate partners, and through government grants and contracts.
There can be no assurance we will be able to obtain additional financing. Although we currently anticipate that we will use the
net proceeds of this offering as described above, there may be circumstances when a reallocation of funds is necessary. The amounts
and timing of our actual expenditures will depend upon numerous factors, including the progress of our development and commercialization
efforts, the progress of our clinical studies, whether or not we enter into strategic collaborations or partnerships, and our operating
costs and expenditures. Accordingly, our management will have significant flexibility in applying the net proceeds of this offering.
The costs and timing of drug development
and regulatory approval, particularly conducting clinical studies, are highly uncertain, subject to substantial risks, and can
often change. Accordingly, we may change the allocation of use of these proceeds as a result of contingencies such as the progress
and results of our clinical studies and other development activities, the establishment of collaborations, our manufacturing requirements,
and regulatory or competitive developments.
Pending the application of the net proceeds
as described above or otherwise, we may invest the proceeds in short-term, investment-grade, interest-bearing securities or guaranteed
obligations of the U.S. government or other securities.
DILUTION
Our net tangible book value as of June 30,
2020, was approximately $20 million, or $0.78 per share of common stock, based upon 25,472,383 shares outstanding. Net tangible
book value per share is determined by dividing such number of outstanding shares of common stock into our net tangible book value,
which is our total tangible assets, less total liabilities.
After
giving effect to the sale of an estimated 10,357,143 shares of our common
stock in this offering at the assumed offering price of $1.40 per share, the last
reported sale price of our common stock on the Nasdaq Capital Market on August 7, 2020, gross proceeds will
be approximately $14.5 million. After deducting the underwriting commission and our estimated offering expenses, our as-adjusted
net tangible book value as of June 30, 2020 would have been $0.95 per share. This represents
an immediate increase in net tangible book value of approximately $0.17 per share to our existing stockholders, and an immediate
dilution of $0.45 per share to investors purchasing securities in the offering.
The following table illustrates the per
share dilution to investors purchasing securities in the offering:
Assumed public offering price per share of common stock
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$
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1.40
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Net tangible book value per share as of June 30, 2020
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$
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0.78
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Increase per share attributable to the sale of securities to investors
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$
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0.17
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Adjusted net tangible book value per share after the offering
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$
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0.95
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Dilution per share to investors in this offering
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$
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0.45
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The dilution information set forth in the table above is illustrative
only and will be adjusted based on the actual sales made during this offering. The information set forth above is based
on shares of common stock outstanding as of June 30, 2020 and excludes, as of August 7, 2020:
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an aggregate of 1,154,250 shares of common stock issued upon the exercise of outstanding warrants and pre-funded warrants issued
since June 30, 2020;
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an aggregate of 1,184,464 shares of common stock issuable upon the exercise of outstanding stock options issued to employees,
directors and consultants;
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an aggregate of 537,500 shares of common stock issuable upon the conversion of outstanding shares of Series C preferred stock;
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an aggregate of 17,937,766 additional shares of common stock reserved for issuance under outstanding warrants having expiration
dates between October 1, 2020, and June 5, 2025, and exercise prices ranging from $1.21 to $283.00 per share; and
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an aggregate
of 186,960 additional shares of common stock reserved for issuance under outstanding pre-funded warrants with no expiration date
and an exercise price of $0.00001 per share.
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DESCRIPTION OF THE SECURITIES WE ARE
OFFERING
The following summary description of
our common stock is based on the provisions of our Second Amended and Restated Certificate of Incorporation, as amended, which
we refer to as our certificate of incorporation or charter, our by-laws, and the applicable provisions of the Delaware General
Corporation Law, which we refer to as the DGCL. This description may not contain all of the information that is important to you
and is subject to, and is qualified in its entirety by reference to, our certificate of incorporation, our by-laws and the applicable
provisions of the DGCL. For information on how to obtain copies of our certificate of incorporation and by-laws, see “Where
You Can Find More Information.”
Authorized and Outstanding Capital Stock
Our authorized capital stock consists of
80,000,000 shares of common stock, $0.00001 par value per share and 7,000 shares of preferred stock, $0.00001 par value per share.
Our certificate of incorporation, as amended, authorizes us to issue shares of our preferred stock from time to time in one or
more series without stockholder approval, each such series to have rights and preferences, including voting rights, dividend rights,
conversion rights, redemption privileges and liquidation preferences, as our Board may determine. The rights of the holders of
common stock will be subject to, and may be adversely affected by, the rights of holders of any preferred stock that we may issue
in the future. The issuance of preferred stock, while providing desirable flexibility in connection with possible acquisitions
and other corporate purposes, could have the effect of making it more difficult for others to acquire, or of discouraging others
from attempting to acquire, a majority of our outstanding voting stock.
As of August 7, 2020, there were 26,626,633
shares of common stock outstanding and 215 shares of preferred stock outstanding. All outstanding shares of our common stock and
preferred stock are duly authorized, validly issued, fully paid and nonassessable.
Common Stock
Voting. Holders
of our common stock are entitled to one vote per share held of record on all matters to be voted upon by our stockholders. Our
common stock does not have cumulative voting rights. Persons who hold a majority of the outstanding common stock entitled to vote
on the election of directors can elect all of the directors who are eligible for election.
Dividends. Subject
to preferences that may be applicable to the holders of any outstanding shares of our preferred stock, the holders of our common
stock are entitled to receive such lawful dividends as may be declared by our Board.
Liquidation and Dissolution. In
the event of our liquidation, dissolution or winding up, and subject to the rights of the holders of any outstanding shares of
our preferred stock, the holders of shares of our common stock will be entitled to receive pro rata all of our remaining assets
available for distribution to our stockholders.
Other Rights and Restrictions. Our
charter prohibits us from granting preemptive rights to any of our stockholders.
PLAN OF DISTRIBUTION
We have entered into the Equity Distribution
Agreement, or the Sales Agreement, with the Sales Agent, under which we may issue and sell from time to time shares of our common
stock having an aggregate offering price of not more than $14,500,000 through the Sales Agent as our sales agent. Sales of the
common stock, if any, will be made by any method permitted by law deemed to be an “at the market offering” as defined
in Rule 415 promulgated under the Securities Act, or in privately negotiated transactions. The Sales Agreement has been filed
as an exhibit to a Current Report on Form 8-K and incorporated by reference into this prospectus and the accompanying prospectus.
The Sales Agent will offer our common stock
at prevailing market prices subject to the terms and conditions of the Sales Agreement as agreed upon by us and the Sales Agent.
We will designate the number of shares which we desire to sell, the time period during which sales are requested to be made, any
limitation on the number of shares that may be sold in one day and any minimum price below which sales may not be made. Subject
to the terms and conditions of the Sales Agreement, the Sales Agent will use its commercially reasonable efforts, consistent with
its sales and trading practices, to sell on our behalf all of the shares of common stock requested to be sold by us. We or the
Sales Agent may suspend the offering of the common stock being made through the Sales Agent under the Sales Agreement upon proper
notice to the other party.
Unless otherwise specified in the applicable
placement notice, settlement for sales of our common stock will occur on the second trading day (or such earlier day as is industry
practice for regular-way trading) following the time at which an acquiror of common stock entered into a contract, binding upon
such acquiror, to acquire such common stock, in return for payment of the net proceeds to us. There is no arrangement for funds
to be received in an escrow, trust or similar arrangement.
We will pay the Sales Agent in cash, upon
each sale of our shares of common stock pursuant to the Sales Agreement, a commission equal to 3.0% of the gross proceeds from
each sale of shares of our common stock. Because there is no minimum offering amount required as a condition to this offering,
the actual total public offering amount, commissions and proceeds to us, if any, are not determinable at this time. Pursuant to
the terms of the Sales Agreement, we agreed to reimburse the Sales Agent for the fees and disbursements of its counsel in an amount
not to exceed (i) $50,000 in connection with the establishment of the at-the-market offering, and (ii) thereafter,
$2,500 on a quarterly basis. We estimate that the total expenses of the offering payable by us, excluding commissions payable
to the Sales Agent under the Sales Agreement, will be approximately $60,000. We will report at least quarterly the number of
shares of common stock sold through the Sales Agent under the Sales Agreement, the net proceeds to us and the compensation paid
by us to the Sales Agent in connection with the sales of common stock.
In connection with the sales of common
stock on our behalf, the Sales Agent will be deemed to be an “underwriter” within the meaning of the Securities Act,
and the compensation paid to the Sales Agent will be deemed to be underwriting commissions or discounts. We have agreed in the
Sales Agreement to provide indemnification and contribution to the Sales Agent against certain liabilities, including liabilities
under the Securities Act and the Exchange Act.
The offering of our shares of common stock
pursuant to the Sales Agreement will terminate upon the earlier of the (i) sale of all of our shares of common stock provided
for in this prospectus, or (ii) termination of the Sales Agreement as permitted therein.
The Sales Agent and its affiliates may
in the future provide various investment banking and other financial services for us and our affiliates, for which services they
may in the future receive customary fees. To the extent required by Regulation M, the Sales Agent will not engage in any market
making activities involving our shares of common stock while the offering is ongoing under this prospectus. This summary of the
material provisions of the Sales Agreement does not purport to be a complete statement of its terms and conditions. We are filing
a copy of the Sales Agreement with the SEC on a Current Report on Form 8-K concurrently with the filing of this prospectus.
Other Relationships
Stefan D. Loren, Ph.D. began serving as
director of Cellectar in June 2015. Dr. Loren is currently a managing director with Oppenheimer & Co. Inc. in
its healthcare investment banking group. Dr. Loren did not participate in the offering on behalf of the Company or Oppenheimer &
Co. Inc.
LEGAL MATTERS
The validity of the securities being offered
by this prospectus has been passed upon for us by Michael Best & Friedrich LLP, Madison, Wisconsin. Ellenoff Grossman &
Schole LLP, New York, New York, is acting as counsel to the underwriter in this offering.
EXPERTS
The audited financial statements incorporated
by reference in this prospectus and elsewhere in the registration statement have been so incorporated by reference in reliance
upon the report of Baker Tilly US, LLP, independent registered public accountants, upon the authority of said firm as experts in
accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We are a reporting company and file annual,
quarterly and special reports, and other information with the SEC. Copies of the reports and other information may be read and
copied at the SEC’s Public Reference Room at 100 F Street NE, Washington, D.C. 20549. You can request copies of such documents
by writing to the SEC and paying a fee for the copying cost. You may obtain information on the operation of the Public Reference
Room by calling the SEC at 1-800-SEC-0330. The SEC maintains a web site at http://www.sec.gov that contains reports, proxy and
information statements and other information regarding registrants that file electronically with the SEC.
This prospectus is part of a registration
statement on Form S-3 that we filed with the SEC. Certain information in the registration statement has been omitted from
this prospectus in accordance with the rules and regulations of the SEC. We have also filed exhibits and schedules with the
registration statement that are excluded from this prospectus. For further information you may:
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·
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read a copy of the registration statement, including the exhibits and schedules, without charge at the SEC’s Public Reference
Room; or
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·
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obtain a copy from the SEC upon payment of the fees prescribed by the SEC.
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We are subject to the information and reporting
requirements of the Exchange Act and, in accordance with this law, are required to file periodic reports, proxy statements and
other information with the SEC. We make available free of charge, on or through the investor relations section of our website,
annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those
reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable
after we electronically file such material with, or furnish it to, the SEC. The information found on our website, other than as
specifically incorporated by reference in this prospectus, is not part of this prospectus.
INCORPORATION OF DOCUMENTS BY REFERENCE
The SEC allows us to “incorporate
by reference” information into this prospectus. This means that we can disclose important information to you by referring
you to another document filed separately with the SEC. The information incorporated by reference is considered to be a part of
this prospectus, except for any information that is superseded by other information that is included in this prospectus.
We incorporate by reference into this prospectus
the following document, which we have previously filed with the SEC:
In addition, all documents subsequently
filed by us pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the termination of the offering will
be deemed to be incorporated by reference into this prospectus.
You should rely only on the information
contained in this prospectus, as updated and supplemented by any prospectus supplement, or that information to which this prospectus
or any prospectus supplement has referred you by reference. We have not authorized anyone to provide you with any additional information.
Any statement contained in a document incorporated
or deemed to be incorporated by reference herein will be deemed to be modified or superseded for purposes of this prospectus to
the extent that a statement contained herein modifies or supersedes such statement. Any statement so modified or superseded will
not be deemed, except as so modified or superseded, to constitute a part of this prospectus.
You may request and obtain a copy of any
of the filings incorporated herein by reference, at no cost, by writing or telephoning us at the following address or phone number:
Cellectar Biosciences, Inc.
100 Campus Drive
Florham Park, New Jersey 07932
Attention: Chief Financial Officer (608) 441-8120
CELLECTAR BIOSCIENCES, INC.
$14,500,000
Common Stock
Prospectus
Oppenheimer &
Co.
,
2020.
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
We estimate that expenses in connection
with the distribution described in this registration statement (other than brokerage commissions, discounts or other expenses relating
to the sale of the shares by the selling stockholders) will be as set forth below. We will pay all of the expenses with respect
to the distribution, and such amounts, with the exception of the Securities and Exchange Commission registration fee and FINRA
fee, are estimates.
Securities and Exchange Commission registration fee
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$
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12,980
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Transfer agent’s and trustee’s fees and expenses
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*
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Printing and engraving expenses
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*
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Legal fees and expenses
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*
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Accounting fees and expenses
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*
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Miscellaneous expenses
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*
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Total
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$
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*
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Item 15. Indemnification of Directors and Officers
Our charter contains provisions to indemnify
our directors and officers to the maximum extent permitted by Delaware law. We believe that indemnification under our charter covers
at least negligence on the part of an indemnified person. Our charter permits us to advance expenses incurred by an indemnified
person in connection with the defense of any action or proceeding arising out of the person’s status or service as our director,
officer, employee or other agent upon an undertaking by the person to repay those advances if it is ultimately determined that
the person is not entitled to indemnification.
Insofar as indemnification for liabilities
arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to
the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission
such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.
The
underwriting agreement to be filed as Exhibit 1.1 to this
Registration Statement provides for indemnification by the underwriter of us and our directors and officers for certain liabilities
under the Securities Act, or otherwise.
Item 16. Exhibits.
(a) Exhibits.
The exhibits to the registration statement
are listed in the Exhibit Index attached hereto and incorporated by reference herein.
(b) Financial Statement Schedules.
Financial statement schedules have been
omitted, as the information required to be set forth therein is included in the consolidated financial statements or notes thereto
appearing in the prospectus made part of this registration statement.
EXHIBIT INDEX
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Incorporated by Reference
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Exhibit
No.
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Description
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Form
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Filing Date
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Exhibit
No.
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1.1*
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Form of Underwriting Agreement
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2.1
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Agreement and Plan of Merger by and among Novelos Therapeutics, Inc., Cell Acquisition Corp. and Cellectar, Inc.
dated April 8, 2011
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8-K
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April 11, 2011
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2.1
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3.1
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Second Amended and Restated Certificate of Incorporation
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8-K
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April 11, 2011
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3.1
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3.2
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Certificate of Ownership and Merger of Cellectar Biosciences, Inc. with and into Novelos Therapeutics, Inc.
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8-K
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February 13, 2014
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3.1
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3.3
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Certificate of Amendment to Second Amended and Restated Certificate of Incorporation
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8-K
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June 13, 2014
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3.1
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3.4
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Certificate of Amendment to Second Amended and Restated Certificate of Incorporation
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8-K
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June 19, 2015
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3.2
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3.5
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Certificate of Amendment to Second Amended and Restated Certificate of Incorporation
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8-K
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March 4, 2016
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3.1
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3.6
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Certificate of Amendment to Second Amended and Restated Certificate of Incorporation
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8-K
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June 1, 2017
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3.2
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3.7
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Certificate of Amendment of Second Amended and Restated Certificate of Incorporation
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8-K
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July 13, 2018
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3.1
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3.8
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Amended and Restated By-laws
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8-K
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June 1, 2011
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3.1
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4.1
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Form of Common Stock Certificate
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S-1/A
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November 9, 2011
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4.1
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4.2*
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Form of Preferred Stock Certificate
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4.3*
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Form of Certificate of Designation with respect to Preferred Stock
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4.4*
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Form of Warrant Agreement
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4.5*
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Form of Unit Agreement
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4.6*
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Form of Subscription Rights Agreement
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5.1**
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Opinion of Michael Best & Friedrich LLP
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|
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23.1**
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Consent of Independent Registered Public Accounting Firm
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23.2**
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Consent of Michael Best & Friedrich LLP (included in Exhibit 5.1)
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24.1***
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Power of Attorney (included on signature page)
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*
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To be filed as an exhibit to a current report of the registrant on Form 8-K or other document to be incorporated herein by reference.
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**
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Filed herewith.
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***
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Included on the signature page to the registration statement.
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Item 17. Undertakings.
The undersigned registrant hereby undertakes
to provide to the underwriter at the closing specified in the underwriting agreement certificates in such denominations and registered
in such names as required by the underwriter to permit prompt delivery to each purchaser.
(a) The undersigned registrant hereby
undertakes:
1. To file, during any period
in which offers or sales are being made, a post-effective amendment to this registration statement:
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(i)
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To include any prospectus required by section 10(a)(3) of the Securities Act of 1933;
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(ii)
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To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most
recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information
set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered
(if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or
high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant
to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum
aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement.
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(iii)
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To include any material information with respect to the plan of distribution not previously disclosed in the registration statement
or any material change to such information in the registration statement;
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provided however, that paragraphs (a)(1)(i), (ii),
and (iii) of this section do not apply if the information required to be included in a post-effective amendment by those paragraphs
is contained in reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or Section 15(d) of
the Exchange Act that are incorporated by reference in the registration statement or contained in a form of prospectus filed pursuant
to § 230.424(b) of the Securities Act that is part of the registration statement.
2. That, for the purpose of
determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the
initial bona fide offering thereof.
3. To remove from registration
by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
4. That, for the purpose of
determining liability under the Securities Act of 1933 to any purchaser:
(A) Each prospectus
filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the
date the filed prospectus was deemed part of and included in the registration statement; and
(B) Each prospectus
required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on
Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing
the information required by Section 10(a) of the Securities Act shall be deemed to be part of and included in the registration
statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract
of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the
issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration
statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration
statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by
reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with
a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement
or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.
5. That, for the purpose of
determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities:
The undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration
statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or
sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser
and will be considered to offer or sell such securities to such purchaser:
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(i)
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Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant
to Rule 424;
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(ii)
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Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred
to by the undersigned registrant;
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(iii)
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The portion of any other free writing prospectus relating to the offering containing material information about the undersigned
registrant or its securities provided by or on behalf of the undersigned registrant; and
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(iv)
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Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
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(b) The undersigned
registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933, each filing of the
registrant's annual report pursuant to section 13(a) or section 15(d) of the Securities Exchange Act of 1934 (and, where
applicable, each filing of an employee benefit plan's annual report pursuant to section 15(d) of the Securities Exchange Act
of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating
to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide
offering thereof.
(c) Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling
persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion
of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore,
unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant
of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered,
the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court
of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and
will be governed by the final adjudication of such issue.
The undersigned registrant
hereby undertakes that:
(1) For
purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed
as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant
pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act of 1933 shall be deemed to be part of
this registration statement as of the time it was declared effective.
(2) For
the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of
prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering thereof.
SIGNATURES
Pursuant to the requirements of the Securities
Act of 1933, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing
on Form S-3 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Florham Park, State of New Jersey, on August 11, 2020.
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CELLECTAR BIOSCIENCES, INC.
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By:
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/s/ James V. Caruso
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James V. Caruso
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President and Chief Executive Officer
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POWER OF ATTORNEY
We, the undersigned officers and directors
of Cellectar Biosciences, Inc., hereby severally constitute and appoint James V. Caruso and Dov Elefant, and each of them
singly (with full power to each of them to act alone), our true and lawful attorneys-in-fact and agents, with full power of substitution
and resubstitution in each of them for him and in his name, place and stead, and in any and all capacities, to sign for us and
in our names in the capacities indicated below any and all amendments (including post-effective amendments) to this registration
statement (or any other registration statement for the same offering that is to be effective upon filing pursuant to Rule 462(b) under
the Securities Act of 1933, as amended), and to file the same, with all exhibits thereto and other documents in connection therewith,
with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and
authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises, as full to
all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and
agents or any of them, or their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities
Act of 1933, this registration statement has been signed by the following persons in the capacities and on the dates indicated.
Signature
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Title
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Date
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/s/James V. Caruso
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Chief Executive Officer and Director
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August 11, 2020
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James V. Caruso
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(principal executive officer)
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/s/ Dov Elefant
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Chief Financial Officer
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August 11, 2020
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Dov Elefant
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(principal financial officer and principal accounting officer)
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/s/ Frederick W. Driscoll
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Director
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August 11, 2020
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Frederick W. Driscoll
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/s/ Stephen A. Hill
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Director
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August 11, 2020
|
Stephen A. Hill
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/s/ Stefan D. Loren, Ph.D.
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Director
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August 11, 2020
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Stefan D. Loren, Ph.D.
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/s/ John Neis
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Director
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August 11, 2020
|
John Neis
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/s/ Douglas J. Swirsky
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Director
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August 11, 2020
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Douglas J. Swirsky
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