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Filed pursuant to Rule
424(b)(5) |
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Registration No.
333-244362 |
SUBJECT TO COMPLETION,
DATED DECEMBER
22, 2020
The information in this preliminary prospectus supplement is not
complete and may be changed. A registration statement relating to
these securities has been declared effective by the Securities and
Exchange Commission. This preliminary prospectus supplement and the
accompanying prospectus are not an offer to sell these securities,
and we are not soliciting offers to buy these securities in any
jurisdiction where the offer or sale thereof is not
permitted.
Preliminary Prospectus
Supplement |
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(to Prospectus dated August 20,
2020) |
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CELLECTAR BIOSCIENCES, INC.
Shares of Common Stock
Pre-Funded Warrants to Purchase up to
Shares
of Common Stock
We are offering
shares
of our common stock at a purchase price of
$ per
share of common stock. We are also offering to certain purchasers
whose purchase of shares of common stock in this offering would
otherwise result in the purchaser, together with its affiliates and
certain related parties, beneficially owning more than 4.99% (or,
at the election of the purchaser, 9.99%) of our outstanding
common stock immediately following the consummation of this
offering, the opportunity to purchase, if any such purchaser so
chooses,
pre-funded warrants, in lieu of shares of common stock that would
otherwise result in such purchaser’s beneficial ownership exceeding
4.99% (or, at the election of the purchaser, 9.99%) of our
outstanding common stock. Each pre-funded warrant will be
exercisable for one share of our common stock. The purchase price
of each pre-funded warrant will be equal to the price at which a
share of common stock is sold to the public in this offering, minus
$0.00001, and the exercise price of each pre-funded warrant will be
$0.00001 per share. The pre-funded warrants will be immediately
exercisable and may be exercised at any time until all of the
pre-funded warrants are exercised in full. This offering also
relates to the shares of common stock issuable upon exercise of any
pre-funded warrants sold in this offering.
In a separate concurrent private placement transaction (the
“PIPE”), we are selling
shares
of common stock and
shares
of Series D convertible preferred stock (“Series D Preferred
Stock”) convertible into a number of shares of common stock equal
to $
divided by
$ (the
“Conversion Price”) (or
shares
of common stock for each share of Series D Preferred Stock
converted), at a price of
$ per
share of Series D Preferred Stock. The Series D Preferred Stock
will only be convertible into common stock upon receipt of
stockholder approval of the issuance of the shares of common stock
as required by Nasdaq Marketplace Rule 5635(d) at a special
stockholder meeting to be called for that purpose. The shares of
common stock, Series D Preferred Stock and the shares of our common
stock issuable upon the exercise of the Series D Preferred Stock,
are not being offered pursuant to this prospectus supplement and
the accompanying prospectus and are being offered pursuant to the
exemption provided in Section 4(a)(2) under the Securities Act and
Rule 506(b) promulgated thereunder.
Our common stock is listed on the Nasdaq Capital Market under the
symbol “CLRB.” On December 21, 2020, the last reported sale price
of our common stock on the Nasdaq Capital Market was $2.66 per
share.
As of December 21, 2020, the aggregate market value of our
outstanding common stock held by non-affiliates was approximately
$72 million, which was calculated based on 27,055,895 shares of
outstanding common stock held by non-affiliates and on a price per
share of $2.66, which was the closing price of our common stock on
the Nasdaq Capital Market on December 21, 2020. As of the
date hereof, we have not offered any securities pursuant to General
Instruction I.B.6 of Form S-3 during the 12 calendar months prior
to and including the date of this prospectus supplement.
You should read this prospectus supplement and the accompanying
prospectus and the documents incorporated by reference in this
prospectus supplement carefully before you invest.
Investing in our securities involves a high degree of risk. See
“Risk Factors” beginning on page S-16 of this prospectus
supplement for more information.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE
SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE
SECURITIES OR PASSED UPON THE ADEQUACY OR ACCURACY OF THIS
PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL
OFFENSE.
We expect that delivery of the shares of our common stock being
offered pursuant to this prospectus supplement and the accompanying
prospectus will be made to purchasers on or about December
, 2020.
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Per Share of
Common Stock |
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Per Pre-Funded
Warrant |
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Total |
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Public offering price |
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$ |
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$ |
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$ |
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Underwriting discount(1) |
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$ |
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$ |
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$ |
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Proceeds, before
expenses, to us |
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$ |
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$ |
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$ |
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(1) |
See “Underwriting” for additional information regarding
underwriting compensation |
Sole Book-Running Manager
Oppenheimer & Co.
The date of this prospectus
supplement is December , 2020.
TABLE OF CONTENTS
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Page |
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ABOUT THIS PROSPECTUS SUPPLEMENT |
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S-2 |
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS |
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S-3 |
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SUMMARY |
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S-5 |
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RISK FACTORS |
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S-15 |
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USE OF
PROCEEDS |
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S-16 |
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DILUTION |
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S-17 |
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DESCRIPTION OF THE SECURITIES WE ARE OFFERING |
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S-18 |
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PRIVATE PLACEMENT TRANSACTION |
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S-19 |
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UNDERWRITING |
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S-20 |
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LEGAL MATTERS |
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S-21 |
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EXPERTS |
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S-22 |
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WHERE YOU CAN FIND ADDITIONAL INFORMATION |
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S-22 |
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INCORPORATION OF CERTAIN INFORMATION BY REFERENCE |
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S-22 |
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ABOUT THIS PROSPECTUS
SUPPLEMENT
This prospectus supplement
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 shares of common stock that may be
offered, issued and sold under this prospectus supplement 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 supplement
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 supplement, 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 supplement. 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 supplement and in any
free writing prospectus that we have authorized for use in
connection with this offering. We have not, and Oppenheimer &
Co. Inc. 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 Oppenheimer
& Co. Inc. 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
supplement, the documents incorporated by reference in this
prospectus supplement, 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
supplement, the documents incorporated by reference in this
prospectus supplement, and any free writing prospectus supplement
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 supplement, 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
future impacts 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 1900 series,
CLR 2000 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. |
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 supplement.
You should read this prospectus supplement 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 supplement
is accurate only as of the date on the front cover of this
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 supplement, and particularly our forward-looking
statements, by these cautionary statements.
SUMMARY
This summary highlights information contained elsewhere in this
prospectus supplement 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
supplement or incorporated herein by reference.
Overview
We are a late-stage clinical biopharmaceutical company focused on
the discovery, development and commercialization of drugs for the
treatment of cancer. 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 studies. However,
COVID-19 may impact our future ability to recruit patients for
clinical studies, obtain adequate supply of CLR 131 and obtain
additional financing.
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 two clinical studies: the
CLOVER-1 Phase 2 Adult B-Cell Malignancy study and the CLOVER-2
Phase 1 pediatric safety study.
The CLOVER-1 study met the primary efficacy endpoints from the Part
A dose-finding portion, conducted in relapsed/refractory (r/r)
B-cell malignancies, and is now enrolling in expansion cohorts to
evaluate triple class refractory multiple myeloma (MM) and Bruton
tyrosine kinase (BTK) inhibitor failed Waldenstrom’s
macroglobulinemia (WM) patients. The dosing regimen is designed to
provide the optimal dose identified in Part A
of >60mCi total body dose.
The CLOVER-2 Phase 1 pediatric study is an open-label,
sequential-group, dose-escalation study to evaluate the safety and
tolerability of CLR 131 in children and adolescents with relapsed
or refractory cancers, including malignant brain tumors,
neuroblastoma, sarcomas, and lymphomas (including Hodgkin’s
lymphoma). The study is being conducted internationally at seven
leading pediatric cancer centers.
The U.S. Food and Drug Administration (“FDA”) granted CLR 131 Fast
Track Designation for both r/r MM and r/r diffuse large B-cell
lymphoma (DLBCL) and Orphan Drug Designation (ODD) of MM, 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. Earlier this year, the European
Commission granted an ODD for r/r MM and most recently, the FDA
granted Fast Track Designation for CLR 131 in WM patients
having received two prior treatment regimens or more.
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 two clinical studies: the CLOVER-1 Phase 2 adult
B-cell malignancy study and the CLOVER-2 Phase 1 pediatric safety
study.
The CLOVER-1 study met the primary efficacy endpoints from the Part
A dose-finding portion, conducted in r/r B-cell malignancies, and
is now enrolling in expansion cohorts to evaluate triple class
refractory MM and BTK inhibitor failed WM patients. The dosing
regimen is designed to provide the optimal dose
of >60mCi total body dose (TBD) identified in Part
A. 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 2A study was to assess the compound’s efficacy in a broad
range of hematologic cancers. In the expansion portion of the study
the goal is to confirm the efficacy of the >60mCi
TBD in triple class refractory MM and BTK inhibitor failed WM
patients. The Phase 1 study was designed to assess the compound’s
safety and tolerability in patients with r/r MM (to determine
maximum tolerated dose (MTD)) and was initiated in April 2015. The
study completed enrollment and the final clinical study report is
expected in the first half of 2021.
The CLOVER-2 Phase 1 pediatric study is being conducted
internationally at seven leading pediatric cancer centers. The
study is an open-label, sequential-group, dose-escalation study to
evaluate the safety and tolerability of CLR 131 in children and
adolescents with relapsed or refractory cancers, including
malignant brain tumors, neuroblastoma, sarcomas, and lymphomas
(including Hodgkin’s lymphoma). 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. In 2018, the FDA granted ODD and RPDD for CLR 131 for the
treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and
osteosarcoma. In May 2019, the FDA granted Fast Track designation
for CLR 131 for the treatment of MM and in July 2019 for the
treatment of DLBCL, in September 2019 CLR 131 received Orphan Drug
Designation from the European Union for Multiple Myeloma, and in
January 2020, the FDA granted Orphan Drug Designation for CLR 131
Waldenstrom’s macrogloulinemia. The FDA granted Fast Track
designation for CLR 131 for the treatment of WM in May 2020.
The FDA may award priority review vouchers to sponsors of a RPDD
that meet its specified criteria. The key criteria to receiving a
priority review voucher (PRV) 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 PRV that can be redeemed to receive a priority review of
a subsequent marketing application for a different product.
Additionally, the PRV’s can be exchanged or sold to other companies
so that the receiving company may use the voucher.
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 >60mCi 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 >60mCi TBD 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 >60mCi 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 <60mCi TBD and the >60mCi 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 35 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.
Based upon the dose response observed in Part A patients receiving
total body doses of 60mCi or greater, we determined that patient
dosing of CLR 131 would be >60mCi TBD. Therefore,
patients are now grouped as receiving <60mCi
or >60mCi TBD. In September 2020, we announced that
a clinically meaningful 40% ORR was observed in the subset of
refractory multiple myeloma patients deemed triple class refractory
who received 60 mCi or greater TBD. Triple class refractory is
defined as patients that are refractory to immunomodulatory,
proteasome inhibitors and anti-CD38 antibody drug classes. The 40%
ORR (6/15 patients) represents triple class refractory patients
enrolled in Part A of Cellectar’s CLOVER-1 study and additional
patients enrolled in Part B from March through May 2020 and
received >60mCi TBD. All MM patients enrolled in the
expansion cohort are required to be triple class refractory. The
additional six patients were heavily pre-treated with an average of
nine prior multi-drug regimens. Three patients received a total
body dose of > 60 mCi and three received less
than 60 mCi. Consistent with the data released in February 2020,
patients receiving > 60 mCi typically exhibit
greater responses. Based on study results to date, patients
continue to tolerate CLR 131 well, with the most common and almost
exclusive treatment emergent adverse events being cytopenias.
We recently held FDA Type B guidance meeting to define the
registrational pathway for our priority adult hematology oncology
indications and planned initiation of the pivotal study for our
lead indication in the fourth quarter
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 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 with a target total body
dose >60 mCi/m2 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/WM 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
secondary endpoints of ORR, progression free survival (PFS,) median
Overall Survival (mOS) and other markers of efficacy following
patients receiving one of three TBDs of CLR 131 (<50mCi, ~50mCi
and >60mCi), with the option for a second cycle
approximately 75-180 days later. Dosages were provided either as
single bolus or fractionated (the assigned dose level split into
two doses) given day 1 and day 15.
In May 2020, we announced that the FDA granted Fast Track
Designation for CLR 131 in WM in patients having received two prior
treatment regimens or more.
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 fractionated doses. The r/r
multiple myeloma patients in this study received single cycle doses
ranging from approximately 20mCi to 90mCi total body dose. 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.
Cohort 5 and 6 were fractionated cohorts of 31.25
mCi/m2(~62.5mCi TBD) and 37.5 mCi/m2(~75mCi
TBD), each administered on day 1 and on day 8. Following the
determination that all prior dosing cohorts were safe and
tolerated, we initiated a cohort 7 utilizing a 40mCi/m2 (~80mCi
TBD) 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. The study completed
enrollment and the final clinical study report is expected in the
first half of 2021.
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 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 efficacious dose of CLR 131 and to determine
preliminary antitumor activity (treatment response) of CLR 131 in
children and adolescents. In August 2020, it was announced that
four dose levels 15mCi/m2 up to
60mCi/m2 were deemed safe and tolerable by an
independent Data Monitoring Committee and evaluation of the next
higher dose cohort, 75mCi/m2 was to initiate. 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. This Priority
Review Voucher Program is currently under evaluation for
renewal.
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 study enrolling up to
30 patients combining CLR 131 and external beam radiation with
recurrent HNC in Q4 2019. This clinical study 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:
|
· |
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. |
|
· |
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 at a future time. |
|
· |
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. |
Key
Risks and Uncertainties
We are subject to numerous risks and uncertainties, including the
following:
|
· |
Our operations and financial condition may be adversely
impacted by the COVID-19 pandemic. |
|
· |
We will require additional capital in order to continue our
operations and may have difficulty raising additional capital. |
|
· |
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. |
|
· |
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. |
|
· |
We will require additional capital in order to continue our
operations and may have difficulty raising additional capital. |
|
· |
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. |
|
· |
We cannot assure the successful development and
commercialization of our compounds in development. |
|
· |
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. |
|
· |
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. |
|
· |
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. |
|
· |
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. |
|
· |
Controls we or our third-party collaborators have in place to
ensure compliance with all applicable laws and regulations may not
be effective. |
|
· |
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. |
|
· |
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. |
|
· |
We are exposed to product, clinical and preclinical liability
risks that could create a substantial financial burden should we be
sued. |
|
· |
Acceptance of our products in the marketplace is uncertain and
failure to achieve market acceptance will prevent or delay our
ability to generate revenues. |
|
· |
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. |
|
· |
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. |
|
· |
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. |
|
· |
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. |
|
· |
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. |
|
· |
We may be subject to claims that our employees have wrongfully
used or disclosed alleged trade secrets of their former
employers. |
|
· |
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. |
|
· |
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. |
|
· |
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. |
|
· |
Our business and operations may be materially, adversely
affected in the event of computer system failures or security
breaches. |
|
· |
Failure to maintain effective internal controls could adversely
affect our ability to meet our reporting requirements. |
|
· |
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. |
|
· |
Our stock price has experienced price fluctuations. |
|
· |
Our common stock could be further diluted as the result of the
issuance of additional shares of common stock, convertible
securities, warrants or options. |
|
· |
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. |
|
· |
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. |
|
· |
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. |
|
· |
You will experience immediate and substantial dilution as a
result of this offering and may experience additional dilution in
the future. |
|
· |
A pre-funded warrant does not entitle the holder to any rights
as common stockholders until the holder exercises the warrant for
shares of our common stock. |
|
· |
There is no public market for the pre-funded warrants being
offered by us in this offering. |
|
· |
You may experience future dilution as a result of future equity
offerings. |
For more information regarding the material risks and uncertainties
we face, please see “Risk Factors” beginning on page S-16 of this
prospectus supplement.
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
supplement.
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
supplement. 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 supplement.
Common stock offered by
us: |
|
shares. |
Pre-funded warrants offered by
us: |
|
We
are also offering to certain purchasers whose purchase of shares of
common stock in this offering would otherwise result in the
purchaser, together with its affiliates and certain related
parties, beneficially owning more than 4.99% (or, at the election
of the purchaser, 9.99%) of our outstanding common stock
immediately following the consummation of this offering, the
opportunity to purchase, if such purchasers so choose,
pre-funded warrants, in lieu of shares of common stock that would
otherwise result in any such purchaser’s beneficial ownership
exceeding 4.99% (or, at the election of the purchaser,
9.99%) of our outstanding common stock. Each pre-funded
warrant will be exercisable for one share of our common stock. The
purchase price of each pre-funded warrant will equal the price at
which a share of common stock is being sold to the public in this
offering, minus $0.00001, and the exercise price of each pre-funded
warrant will be $0.00001 per share. The pre-funded warrants will be
exercisable immediately and may be exercised at any time until all
of the pre-funded warrants are exercised in full. This offering
also relates to the shares of common stock issuable upon exercise
of any pre-funded warrants sold in this offering. For each
pre-funded warrant we sell, the number of shares of common stock we
are offering will be decreased on a one-for-one basis. For
additional information, see “Description of Securities—Pre-Funded
Warrants to be Issued as Part of this Offering” on page 19 of this
prospectus supplement. |
Shares of common stock outstanding before
this offering: |
|
27,260,968 shares |
Use of Proceeds: |
|
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.” |
Risk Factors: |
|
See
“Risk Factors” beginning on page S-16 and the other information
included in this prospectus supplement for a discussion of factors
you should carefully consider before deciding whether to purchase
our securities. |
Nasdaq symbol for our common
stock: |
|
CLRB |
Concurrent Private
Placement: |
|
In a separate concurrent PIPE transaction, we are
selling
shares
of common stock at a purchase price of
$ per
share and
shares
of Series D Preferred Stock convertible into a number of shares of
common stock equal to
$
divided by the Conversion Price (or
shares
of common stock for each share of Series D Preferred Stock
converted), at a price of
$ per
share of Series D Preferred Stock. The Series D Preferred Stock
will only be convertible into common stock upon receipt of
stockholder approval of the issuance of the shares of common stock
as required by Nasdaq Marketplace Rule 5635(d) at a special
stockholder meeting to be called for that purpose. The shares of
common stock, Series D Preferred Stock and the shares of our common
stock issuable upon the exercise of the Series D Preferred Stock,
are not being offered pursuant to this prospectus supplement and
the accompanying prospectus and are being offered pursuant to the
exemption provided in Section 4(a)(2) under the Securities Act and
Rule 506(b) promulgated thereunder. See “Private Placement
Transaction.” |
Shares of common stock to be outstanding
after this offering: |
|
shares |
Shares of Series D Preferred Stock to be
outstanding after this offering: |
|
shares |
No listing of Pre-Funded Warrants or Series
D Preferred Stock: |
|
We
do not intend to apply for listing of the pre-funded warrants or
shares of Series D Preferred Stock on any securities exchange or
trading system |
Unless we specifically state otherwise, the share information in
this prospectus, including the number of shares of common stock
outstanding before this offering, is as of December 21, 2020.
The number of shares of our common stock outstanding before and
after this offering is based on 27,260,968 shares of common stock
outstanding as of December 21, 2020 and excludes, as of that
date:
·
an aggregate of 1,184,464 shares of common stock issuable upon the
exercise of outstanding stock options issued to employees,
directors and consultants;
·
an aggregate of 537,500 shares of common stock issuable upon the
conversion of outstanding shares of Series C preferred stock
·
an aggregate of 17,489,891 additional shares of common stock
reserved for issuance under outstanding warrants having expiration
dates between April 1, 2021, and June 5, 2025, and exercise prices
ranging from $1.21 to $30.40 per share; and
·
shares
of our common stock that may be issued upon the exercise of
pre-funded warrants issued in this offering and [_] shares of our
common stock that may be issued upon the conversion of the Series D
Preferred Stock issued in the PIPE.
Unless otherwise noted, the information in this prospectus
supplement reflects and assumes no exercise of outstanding options
and warrants.
|
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 supplement, 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 supplement and that are
incorporated by reference herein. 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 supplement, 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.
You will experience immediate and substantial dilution as a
result of this offering and may experience additional dilution in
the future.
You will incur immediate and substantial dilution as a result of
this offering. After giving effect to the sale by of the securities
offered in this offering, at a public offering price of
$ per
share, and after deducting the underwriter’s discounts and
commissions and other estimated offering expenses payable by us,
investors in this offering can expect an immediate dilution of
$0. per
share, or
%,
assuming no exercise of the warrants. In addition, in the past, we
have issued preferred stock, options and warrants to acquire shares
of common stock. To the extent these options are ultimately
exercised, you will sustain future dilution.
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.
There is no public market for the warrants or the pre-funded
warrants being offered by us in this offering.
There is no established public trading market for the pre-funded
warrants being offered in this offering, and we do not expect a
market to develop. In addition, we do not intend to apply to list
the pre-funded warrants on any national securities exchange or
other nationally recognized trading system, including The Nasdaq
Capital Market. Without an active market, the liquidity of the
pre-funded warrants will be limited.
USE OF PROCEEDS
We estimate that the net proceeds to us from the sale of the
securities that we are offering will be approximately
$
million, after deducting underwriting discounts and commissions and
estimated offering expenses.
We expect to use any proceeds received from this offering as
follows:
|
· |
research and development
activities, including the further development of CLR 131, and the
research advancement of our PDC platform, including product
candidates, CLR 1900, CLR 2000 and CLR 12120. |
|
· |
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. |
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 September 30, 2020, was
approximately $16.2 million, or $0.61 per share of common stock,
based upon 26,813,593 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
shares
of our common stock and
pre-funded warrants in this offering, and assuming issuance of all
shares of common stock underlying the pre-funded warrants, and
shares of common stock and Series D Preferred Stock to be sold in
the concurrent PIPE, and assuming the issuance of all of the shares
of common stock underlying the Series D Preferred Stock, each at
the offering price of
$
per share, gross
proceeds will be approximately
$ million.
After deducting the underwriting commission and our estimated
offering expenses, our as-adjusted net tangible book value as of
September 30, 2020 would have been
$ per
share. This represents an
immediate increase in net tangible book value of approximately
$ per
share to our existing stockholders, and an immediate dilution of
$ per
share to investors purchasing securities in the
offering.
The following table illustrates the per share dilution to investors
purchasing securities in the offering:
Public offering price per
share of common stock |
|
|
|
|
|
$ |
|
|
Net
tangible book value per share as of September 30, 2020 |
|
$ |
0.61 |
|
|
|
|
|
Increase per share attributable to the sale of securities to
investors |
|
$ |
|
|
|
|
|
|
Adjusted net tangible book value per share after the offering |
|
|
|
|
|
$ |
|
|
Dilution per share to investors in this offering |
|
|
|
|
|
$ |
|
|
The foregoing illustration does not reflect potential dilution from
the exercise of outstanding options or warrants to purchase shares
of our common stock. 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
September 30, 2020 and excludes, as of December 21, 2020:
|
· |
an aggregate of 447,500 shares of common stock issued upon the
exercise of outstanding warrants issued and an aggregate of 125
shares of common stock that were surrendered since September 30,
2020; |
|
· |
an aggregate of 1,184,464 shares of common stock issuable upon
the exercise of outstanding stock options issued to employees,
directors and consultants; |
|
· |
an aggregate of 537,500 shares of common stock issuable upon
the conversion of outstanding shares of Series C preferred
stock; |
|
· |
an aggregate of 17,489,891 additional shares of common stock
reserved for issuance under outstanding warrants having expiration
dates between April 1, 2021, and June 5, 2025, and exercise prices
ranging from $1.21 to $30.40 per share; and |
|
· |
shares of our common stock that may be issued upon the exercise of
pre-funded warrants issued in this offering and
shares
of our common stock that may be issued upon the conversion of the
Series D Preferred Stock issued in the PIPE.
|
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 December 21, 2020, there were 27,260,968 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.
Pre-Funded Warrants to be Issued as Part of this
Offering
Duration and Exercise Price. Each
pre-funded warrant offered hereby will have an initial exercise
price per share equal to $0.00001. The pre-funded warrants will be
immediately exercisable and may be exercised at any time until the
pre-funded warrants are exercised in full. The exercise price and
number of shares of common stock issuable upon exercise is subject
to appropriate adjustment in the event of stock dividends, stock
splits, reorganizations or similar events affecting our common
stock and the exercise price. The pre-funded warrants will be
issued separately from the accompanying common warrants, and may be
transferred separately immediately thereafter.
Exercisability. The pre-funded warrants
will be exercisable, at the option of each holder, in whole or in
part, by delivering to us a duly executed exercise notice
accompanied by payment in full for the number of shares of our
common stock purchased upon such exercise (except in the case of a
cashless exercise as discussed below). Purchasers of the pre-funded
warrants in this offering may elect to deliver their exercise
notice following the pricing of the offering and prior to the
issuance of the pre-funded warrants at closing to have their
pre-funded warrants exercised immediately upon issuance and receive
shares of common stock underlying the pre-funded warrants upon
closing of this offering. A holder (together with its affiliates)
may not exercise any portion of the pre-funded warrant to the
extent that the holder would own more than 4.99% of the outstanding
common stock immediately after exercise, except that upon at least
61 days’ prior notice from the holder to us, the holder may
increase the amount of ownership of outstanding stock after
exercising the holder’s pre-funded warrants up to 9.99% of the
number of shares of our common stock outstanding immediately after
giving effect to the exercise, as such percentage ownership is
determined in accordance with the terms of the pre-funded warrants.
Purchasers of pre-funded warrants in this offering may also elect
prior to the issuance of the pre-funded warrants to have the
initial exercise limitation set at 9.99% of our outstanding common
stock. No fractional shares of common stock will be issued in
connection with the exercise of a pre-funded warrant. In lieu of
fractional shares, we will round down to the next whole share.
Cashless Exercise. If, at the time a
holder exercises its pre-funded warrants, a registration statement
registering the issuance of the shares of common stock underlying
the pre-funded warrants under the Securities Act is not then
effective or available, then in lieu of making the cash payment
otherwise contemplated to be made to us upon such exercise in
payment of the aggregate exercise price, the holder may elect
instead to receive upon such exercise (either in whole or in part)
the net number of shares of common stock determined according to a
formula set forth in the pre-funded warrants.
Transferability. Subject to applicable
laws, a pre-funded warrant may be transferred at the option of the
holder upon surrender of the pre-funded warrant to us together with
the appropriate instruments of transfer.
Exchange Listing. There is no trading
market available for the pre-funded warrants on any securities
exchange or nationally recognized trading system. We do not intend
to list the pre-funded warrants on any securities exchange or
nationally recognized trading system.
Right as a Stockholder. Except as otherwise provided
in the pre-funded warrants or by virtue of such holder’s ownership
of shares of our common stock, the holders of the pre-funded
warrants do not have the rights or privileges of holders of our
common stock, including any voting rights, until they exercise
their pre-funded warrants.
Fundamental Transaction. In the event of
a fundamental transaction, as described in the pre-funded warrants
and generally including any reorganization, recapitalization or
reclassification of our common stock, the sale, transfer or other
disposition of all or substantially all of our properties or
assets, our consolidation or merger with or into another person,
the acquisition of more than 50% of our outstanding common stock,
or any person or group becoming the beneficial owner of 50% of the
voting power represented by our outstanding common stock, the
holders of the pre-funded warrants will be entitled to receive upon
exercise of the pre-funded warrants the kind and amount of
securities, cash or other property that the holders would have
received had they exercised the pre-funded warrants immediately
prior to such fundamental transaction.
PRIVATE PLACEMENT TRANSACTION
In the separate PIPE, we are selling
shares
of common stock and
shares
of Series D Preferred Stock. The shares of common stock were priced
at $
per share and the Series D Preferred Stock are convertible into a
number of shares of common at the Conversion Price (or
shares
of common stock for each share of Series D Preferred Stock
converted), at a price of
$ per
share of Series D Preferred Stock.
The offering and sale of the shares of comment stock, the Series D
Preferred Stock and the shares of our common stock issuable upon
the conversion of the Series D Preferred Stock are not being
registered under the Securities Act, are not being offered pursuant
to this prospectus supplement and the accompanying prospectus and
are being offered pursuant to the exemption provided in Section
4(a)(2) under the Securities Act and Rule 506(b) promulgated
thereunder. Accordingly, purchasers may only sell shares acquired
in the PIPE pursuant to an effective registration statement under
the Securities Act covering the resale of those shares, an
exemption under Rule 144 under the Securities Act or another
applicable exemption under the Securities Act.
We will be required to file a registration statement on either Form
S-3 or Form S-1 within 30 days of closing of the private placement
to provide for the resale of the shares of common stock and common
stock issuable upon the conversion of the Series D Preferred Stock,
and will be obligated to use our reasonable best efforts to keep
such registration statement effective until the earlier of (i) the
date on which the shares of common stock and common stock issuable
upon conversion of the Series D Preferred Stock may be sold without
registration pursuant to Rule 144 under the Securities Act, and
(ii) the date on which all of the shares of common stock and common
stock issuable upon conversion of the Series D Preferred Stock have
been sold under the registration statement or pursuant to Rule 144
under the Securities Act or any other rule of similar effect.
UNDERWRITING
We entered into an
underwriting agreement with Oppenheimer & Co. Inc. on
,
2020 as the sole book-running manager of this offering. The
underwriting agreement provides for the purchase of a specific
number of shares of common stock and/or pre-funded warrants by the
underwriter. Subject to the terms and conditions of the
underwriting agreement, the underwriter has agreed to purchase the
number of shares and pre-funded warrants set forth
below:
Underwriter |
|
Number of
Shares of Common
Stock |
|
Number of
Pre-Funded
Warrants |
Oppenheimer & Co.
Inc. |
|
|
|
|
Total |
|
|
|
|
The underwriter has agreed to
purchase all of the shares of common stock and/or pre-funded
warrants offered by this prospectus supplement, if any are
purchased.
The shares of common stock
and/or pre-funded warrants offered hereby are expected to be ready
for delivery on or about
,
2020 against payment in immediately available funds.
The underwriter is offering
the shares of common stock and/or pre-funded warrants subject to
various conditions and may reject all or part of any order in their
sole discretion. The underwriter proposes to initially offer the
shares of common stock and/or pre-funded warrants to purchase
shares of common stock to the public at the public offering price
set forth on the cover page of this prospectus supplement and to
dealers at a price less a concession not in excess of
$ per share. After the
shares of common stock and/or pre-funded warrants are released for
sale to the public, the underwriter may change the offering price,
the concession, and other selling terms at various
times.
The following table provides
information regarding the amount of the discounts and commissions
to be paid to the underwriter by us, before expenses:
|
|
Per Share of Common Stock |
|
|
Per Pre-Funded Warrant |
|
Total |
|
Public
offering price(1) |
|
$ |
|
|
|
$ |
|
|
$ |
|
|
Underwriting discount
(7.0%) |
|
$ |
|
|
|
$ |
|
|
$ |
|
|
Proceeds, before expenses, to
us |
|
$ |
|
|
|
$ |
|
|
$ |
|
|
We estimate that our total expenses of the offering, excluding the
estimated underwriting discounts and commissions, will be
approximately $ , which
includes the fees and expenses for which we have agreed to
reimburse the representative, provided that any such fees and
expenses in excess of an aggregate of $125,000 will be subject to
our prior written approval.
Regulation
M
Rules of the Securities and
Exchange Commission may limit the ability of the underwriters to
bid for or purchase shares before the distribution of the shares is
completed. However, the underwriter may engage in the following
activities in accordance with the rules:
|
· |
Passive market making - market
makers in the shares who are underwriters or prospective
underwriters may make bids for or purchases of shares, subject to
limitations, until the time, if ever, at which a stabilizing bid is
made. |
Neither we nor the
underwriter make any representation or prediction as to the effect
that the transactions described above may have on the price of the
shares. These transactions may occur on The Nasdaq Capital Market
or otherwise. If such transactions are commenced, they may be
discontinued without notice at any time.
Electronic Delivery of
Prospectus Supplement
A prospectus supplement in
electronic format may be delivered to potential investors by the
underwriter. The prospectus supplement in electronic format will be
identical to the paper version of such prospectus supplement. Other
than the prospectus supplement in electronic format, the
information on the underwriter’s website and any information
contained in any other website maintained by an underwriter is not
part of this prospectus supplement or the registration statement of
which this prospectus supplement forms a part.
Determination of Offering Price
Our common stock is currently traded on the Nasdaq Capital Market
under the symbol “CLRB.” On December 21, 2020, the closing price of
our common stock was $2.66 per share.
The public offering price of the securities offered by this
prospectus supplement
will be determined by negotiation between us and the underwriter.
Among the factors considered in determining the public offering
price of the shares were:
|
· |
our history and our
prospects; |
|
· |
the industry in which we
operate; |
|
· |
our past and present operating
results; |
|
· |
the previous experience of our
executive officers; and |
|
· |
the general condition of the
securities markets at the time of this offering |
The offering price stated on the cover page of this prospectus
supplement should not
be considered an indication of the actual value of the securities.
That price is subject to change as a result of market conditions
and other factors, and we cannot assure you that the securities can
be resold at or above the public offering price.
Lock-up Agreements
Our officers and directors have agreed with the underwriter to be
subject to a lock-up period of 90 days following the date of this
prospectus supplement.
This means that, during the applicable lock-up period, such persons
may not offer for sale, contract to sell, sell, distribute, grant
any option, right or warrant to purchase, pledge, hypothecate or
otherwise dispose of, directly or indirectly, any shares of our
common stock or any securities convertible into, or exercisable or
exchangeable for, shares of our common stock. Certain limited
transfers are permitted during the lock-up period if the transferee
agrees to these lock-up restrictions. We have also agreed, in the
underwriting agreement, to similar lock-up restrictions on the
issuance and sale of our securities for 90 days following the
closing of this offering, although we will be permitted to issue
stock options or stock awards to directors, officers and employees
under our existing plans. The lock-up period is subject to an
additional extension to accommodate for our reports of financial
results or material news releases. The representative may, in its
sole discretion and without notice, waive the terms of any of these
lock-up agreements.
Right of First Refusal
Upon completion of an
offering that meets certain criteria, we have granted Oppenheimer
& Co. Inc. a right of first refusal to act as lead underwriter,
lead initial purchaser, lead placement agent or lead selling agent,
as the case may be, in connection with any subsequent financing by
us. This right of first refusal extends for seven months from the
effective date of this registration statement. The terms of any
such engagement of Oppenheimer & Co. Inc. will be determined by
separate agreement.
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.
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is American
Stock Transfer and Trust Company.
Indemnification
We have agreed to indemnify the underwriter and selected dealers
against certain liabilities, including certain liabilities arising
under the Securities Act, or to contribute to payments that the
underwriter or selected dealers may be required to make for these
liabilities.
LEGAL MATTERS
The validity of the securities being offered by this prospectus
supplement 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 supplement 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 supplement 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
supplement 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 supplement. For
further information you may:
|
· |
read a copy of the registration statement, including the
exhibits and schedules, without charge at the SEC’s Public
Reference Room; or |
|
· |
obtain a copy from the SEC upon payment of the fees prescribed
by the SEC. |
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
supplement, is not part of this prospectus supplement.
INCORPORATION OF DOCUMENTS BY
REFERENCE
The SEC allows us to “incorporate by reference” information into
this prospectus supplement. 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 supplement,
except for any information that is superseded by other information
that is included in this prospectus supplement.
We incorporate by reference into this prospectus supplement 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 supplement.
You should rely only on the information contained in this
prospectus supplement or that information to which this 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 supplement 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 supplement.
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.
shares of Common Stock
Pre-Funded Warrants to Purchase up to
Shares
of Common Stock
Sole Book-Running
Manager
Oppenheimer &
Co.
, 2020.
CELLECTAR BIOSCIENCES, INC.
$100,000,000
Common Stock
Preferred Stock
Warrants
Units
Subscription Rights
Cellectar Biosciences, Inc. (“we,” “us” or the “Company”) may
from time to time offer to sell any combination of the securities
described in this prospectus, in one or more offerings. The
aggregate initial offering price of all securities sold under this
prospectus will not exceed $100,000,000.
This prospectus provides a general description of the securities we
may offer. Each time we sell securities, we will provide specific
terms of the securities offered in a supplement to this prospectus.
We may also authorize one or more free writing prospectuses to be
provided to you in connection with these offerings. The prospectus
supplement and any related free writing prospectus may also add,
update or change information contained in this prospectus. You
should carefully read this prospectus, the applicable prospectus
supplement and any related free writing prospectus, as well as any
documents incorporated by reference herein or therein before you
invest in any securities.
This prospectus may not be used to consummate a sale of any
securities unless accompanied by a prospectus supplement.
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.
The applicable prospectus supplement will contain information,
where applicable, as to any other listing on the Nasdaq Capital
Market or any securities market or other exchange of the
securities, if any, covered by the prospectus supplement.
At no time will we issue shares of common stock (whether upon
conversion or exercise of warrants, preferred stock, units or
subscription rights) in a transaction other than a public offering
if such transaction would result in the issuance of more than
19.999% of the amount of common stock issued and outstanding for
less than the greater of book or market value of the common stock
unless (i) our stockholders have approved the issuance of
shares of common stock in excess of 20%, or (ii) Nasdaq
has provided a waiver of Listing Rule 5635(d).
We may sell these securities directly to investors, through agents
designated from time to time or to or through underwriters or
dealers. For additional information on the methods of sale, you
should refer to the section entitled “Plan of Distribution” in this
prospectus. If any underwriters are involved in the sale of any
securities with respect to which this prospectus is being
delivered, the names of such underwriters and any applicable
commissions or discounts will be set forth in a prospectus
supplement. The price to the public of such securities and the net
proceeds we expect to receive from such sale will also be set forth
in a prospectus supplement.
Investing in our securities involves a high degree of risk. See
“Risk Factors” beginning on page 11 of this prospectus for
more information.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE
SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE
SECURITIES OR PASSED UPON THE ADEQUACY OR ACCURACY OF THIS
PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL
OFFENSE.
The date of this prospectus is
,
2020.
TABLE OF CONTENTS
ABOUT THIS
PROSPECTUS
This prospectus is a part of a registration statement that we filed
with the Securities and Exchange Commission (the “SEC”) utilizing a
“shelf” registration process. Under this shelf registration
process, we may sell any combination of the securities described in
this prospectus in one or more offerings up to a total dollar
amount of $100,000,000. This prospectus provides you with a general
description of the securities we may offer. Each time we sell
securities under this shelf registration, we will provide a
prospectus supplement that will contain specific information about
the terms of that offering. We may also authorize one or more free
writing prospectuses to be provided to you that may contain
material information relating to these offerings. The prospectus
supplement and any related free writing prospectus that we may
authorize to be provided to you may also add, update or change
information contained in this prospectus or in any documents that
we have incorporated by reference into this prospectus. You should
read this prospectus, any applicable prospectus supplement and any
related free writing prospectus, together with the information
incorporated herein by reference as described under the heading
“Where You Can Find Additional Information.”
You should rely only on the information that we have provided or
incorporated by reference in this prospectus, any applicable
prospectus supplement and any related free writing prospectus that
we may authorize to be provided to you. We have not authorized any
dealer, salesman or other person to give any information or to make
any representation other than those contained or incorporated by
reference in this prospectus, any applicable prospectus supplement
or any related free writing prospectus that we may authorize to be
provided to you. You must not rely upon any information or
representation not contained or incorporated by reference in this
prospectus, the accompanying prospectus supplement or related free
writing prospectus. We take no responsibility for, and can provide
no assurance as to the reliability of, any other information that
others may give you.
This prospectus, the accompanying supplement to this prospectus and
any related free writing prospectus, if any, do not constitute an
offer to sell or the solicitation of an offer to buy any securities
other than the registered securities to which they relate, nor do
this prospectus, the accompanying supplement to this prospectus or
any related free writing prospectus, if any, constitute an offer to
sell or the solicitation of an offer to buy securities in any
jurisdiction to any person to whom it is unlawful to make such
offer or solicitation in such jurisdiction. You should not assume
that the information contained in this prospectus, any applicable
prospectus supplement or any related free writing prospectus is
accurate on any date subsequent to the date set forth on the front
of the document or that any information we have incorporated by
reference therein is correct on any date subsequent to the date of
the document incorporated by reference, even though this
prospectus, any applicable prospectus supplement or any related
free writing prospectus is delivered or the applicable securities
are sold on a later date.
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. |
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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Warrants issued in this offering may not have any value. |
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A warrant does not entitle the holder to any rights as common
stockholders until the holder exercises the warrant for shares of
our common stock. |
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There is no public market for any securities other than our
common stock being offered by us in this offering. |
For more information regarding the material risks and uncertainties
we face, please see “Risk Factors” beginning on page 11 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.
Securities We May Offer
We may offer shares of our common stock and preferred stock,
various series of warrants to purchase any of such securities,
either individually or in units and/or subscription rights, from
time to time under this prospectus, together with any applicable
prospectus supplement and related free writing prospectus, at
prices and on terms to be determined by market conditions at the
time of offering. This prospectus provides you with a general
description of the securities we may offer. Each time we offer a
type or series of securities, we will provide a prospectus
supplement that will describe the specific amounts, prices and
other important terms of the securities, including, to the extent
applicable:
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designation or classification; |
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aggregate principal amount or aggregate offering price; |
|
• |
rates and times of payment of dividends, if any; |
|
• |
redemption, conversion or exchange terms, if any; |
|
• |
conversion or exchange prices or rates, if any, and, if
applicable, any provisions for changes to or adjustments in the
conversion or exchange prices or rates and in the securities or
other property receivable upon conversion or exchange; |
|
• |
restrictive covenants, if any; |
|
• |
voting or other rights, if any; and |
|
• |
important United States federal income tax considerations. |
A prospectus supplement and any related free writing prospectus
that we may authorize to be provided to you may also add, update or
change information contained in this prospectus or in documents we
have incorporated by reference. However, no prospectus supplement
or free writing prospectus will offer a security that is not
registered and described in this prospectus at the time of the
effectiveness of the registration statement of which this
prospectus is a part.
We may sell the securities directly to or through underwriters,
dealers or agents. We, and our underwriters or agents, reserve the
right to accept or reject all or part of any proposed purchase of
securities. If we do offer securities through underwriters or
agents, we will include in the applicable prospectus
supplement:
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• |
the names of those underwriters or agents; |
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• |
applicable fees, discounts and commissions to be paid to
them; |
|
• |
details regarding over-allotment options, if any; and |
|
• |
the net proceeds to us. |
Common Stock
We may offer shares of our common stock, par value $0.00001 per
share, either alone or underlying other registered securities
convertible into or exercisable for our common stock. Holders of
our common stock are entitled dividends as the Board of Directors
of the Company (the “Board”) may declare from time to time out of
legally available funds, subject to the preferential rights of the
holders of any shares of our preferred stock that are outstanding
or that we may issue in the future. Currently, we have 215 issued
and outstanding shares of preferred stock. Each holder of our
common stock is entitled to one vote per share. In this prospectus,
we provide a general description of, among other things, our
dividend policy and the rights and restrictions that apply to
holders of our common stock. Our common stock is described in
greater detail in this prospectus under “Description of Capital
Stock — Common Stock.”
Preferred Stock
We may issue shares of preferred stock, par value $0.00001 per
share, in one or more classes or series. Our Board or a committee
designated by our Board will determine the dividend, voting and
conversion rights and other provisions at the time of sale. The
particular terms of each class or series of preferred stock,
including redemption privileges, liquidation preferences, voting
rights, dividend rights and/or conversion rights, will be more
fully described in the applicable prospectus supplement relating to
the preferred stock offered thereby. Our preferred stock is
described in greater detail in this prospectus under “Description
of Capital Stock — Preferred Stock.”
Warrants
We may from time to time offer warrants for the purchase of our
common stock and/or preferred stock in one or more series. We may
issue warrants independently or together with common stock and/or
preferred, and the warrants may be attached to or separate from
those securities. The warrants may be evidenced by warrant
certificates issued under one or more warrant agreements, which are
contracts between us and an agent for the holders of the warrants.
In this prospectus, we have summarized certain general features of
the warrants under “Description of Warrants.” We urge you, however,
to read the prospectus supplements and any free writing prospectus
that we may authorize to be provided to you related to the series
of warrants being offered, as well as the complete warrant
agreements and warrant certificates that contain the terms of the
warrants. Specific warrant agreements will contain additional
important terms and provisions and will be incorporated by
reference as an exhibit to the registration statement which
includes this prospectus.
Units
We may offer units consisting of common stock, preferred stock,
and/or warrants to purchase any of such securities in one or more
series. In this prospectus, we have summarized certain general
features of the units under “Description of Units.” We urge you,
however, to read the prospectus supplements and any free writing
prospectus that we may authorize to be provided to you related to
the series of units being offered, as well as the unit agreements
that contain the terms of the units. We will evidence each series
of units by unit certificates that we will issue under a separate
agreement. We will enter into the unit agreements with a unit
agent. Each unit agent will be a bank or trust company that we
select. We will indicate the name and address of the unit agent in
the applicable prospectus supplement relating to a particular
series of units. The specific form of unit agreement and any
supplemental agreements that describe the terms of the series of
units we are offering before the issuance of the related series of
units will be incorporated by reference as an exhibit to the
registration statement which includes this prospectus.
Subscription Rights
We may issue subscription rights to purchase common
stock, preferred stock or other securities described in this
prospectus or any combination thereof. In this prospectus, we have
summarized certain general features of the units under “Description
of Subscription Rights.” These subscription rights may be
issued independently or together with any other security offered by
us and may or may not be transferable by the securityholder
receiving the subscription rights in such offering. In
connection with any offering of subscription rights, we may
enter into a standby arrangement with one or more underwriters or
other investors pursuant to which the underwriters or other
investors may be required to purchase any securities remaining
unsubscribed for after such offering. The specific form of
subscription rights agreement and any supplemental agreements that
describe the terms of the subscription rights we are offering
before the issuance of the related subscription rights will be
incorporated by reference as an exhibit to the registration
statement which includes this prospectus.
RISK FACTORS
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 or the applicable prospectus
supplement, 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.”
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; |
|
· |
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; |
|
· |
the progress of our
product development programs, including clinical testing and the
timing of commencement and results thereof; |
|
· |
our projected
operating results, including research and development
expenses; |
|
· |
our ability to
continue development plans for CLR 131, CLR 1800 series, CLR 1900
series, CLR 2000 series, CLR 2100 series, CLR 2200 series and CLR
12120; |
|
· |
our ability to
continue development plans for our Phospholipid Drug Conjugates
(PDC)™; |
|
· |
our ability to maintain orphan drug
designation in the U.S. for 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; |
|
· |
any disruptions at our sole supplier of CLR
131; |
|
· |
our ability to pursue strategic
alternatives; |
|
· |
our ability to advance our technologies into
product candidates; |
|
· |
our enhancement and consumption of current
resources along with ability to obtain additional funding; |
|
· |
our current view regarding general economic
and market conditions, including our competitive strengths; |
|
· |
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; |
|
· |
assumptions underlying any of the foregoing;
and |
|
· |
any other statements that address events or
developments that we intend or believe will or may occur in the
future. |
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.
USE OF PROCEEDS
Unless we
specify otherwise in a prospectus supplement, we intend to use the
net proceeds from our sale of the securities under this prospectus
for general corporate purposes, which may include making additions
to our working capital, funding future acquisitions, or for any
other purpose we describe in the applicable prospectus
supplement.
We have not yet determined the amount of net proceeds to be used
specifically for any of the foregoing purposes. Accordingly, our
management will have broad discretion over the uses of such
proceeds. The specific allocations of the proceeds we receive from
the sale of our securities will be described in the applicable
prospectus supplement.
DESCRIPTION OF SECURITIES
WE MAY OFFER
We may offer shares of our common stock and preferred stock,
various series of warrants to purchase any of such securities,
either individually or in units and/or subscription rights, from
time to time under this prospectus, together with any applicable
prospectus supplement and related free writing prospectus, at
prices and on terms to be determined by market conditions at the
time of offering. This prospectus provides you with a general
description of the securities we may offer. Each time we offer a
type or series of securities, we will provide a prospectus
supplement that will describe the specific amounts, prices and
other important terms of the securities. We may offer up to
$100,000,000 of securities under this prospectus.
DESCRIPTION OF CAPITAL
STOCK
The following description of our common stock and preferred stock,
together with any additional information we include in any
applicable prospectus supplement or any applicable free writing
prospectus, summarizes the material terms and provisions of our
common stock and the preferred stock that we may offer under this
prospectus. While the terms we have summarized below will apply
generally to any future common stock or preferred stock that we may
offer, we will describe the particular terms of any class or series
of these securities in more detail in the applicable prospectus
supplement. 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, 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. Our certificate of incorporation and our by-laws are
incorporated by reference into the registration statement of which
this prospectus is a part or may be incorporated by reference in
this prospectus or any applicable prospectus supplement.
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 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, we had 26,626,633 shares of common stock
outstanding and 215 shares of preferred stock outstanding. All
outstanding shares of our common stock are duly authorized, validly
issued, fully paid and non-assessable.
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 certificate of
incorporation prohibits us from granting preemptive rights to any
of our stockholders.
All of the outstanding shares of our common stock are, and the
shares of common stock issued upon the conversion of any securities
convertible into our common stock will be, fully paid and
non-assessable. The shares of common stock offered by this
prospectus or upon the conversion of any preferred stock or
exercise of any warrants offered pursuant to this prospectus, when
issued and paid for, will also be, fully paid and
non-assessable.
Our common stock is listed on the Nasdaq Capital Market under the
symbol CLRB. The transfer agent and registrar for our common stock
is American Stock Transfer & Trust Company.
Preferred Stock
We are authorized to issue 7,000 shares of preferred stock, 215 of
which were issued and outstanding as of August 7, 2020. Our
Board is authorized, without action by our stockholders, to
classify or reclassify any unissued portion of our authorized
shares of preferred stock to provide for the issuance of shares of
other classes or series, including preferred stock in one or more
series. Our Board may fix or alter the dividend rights, dividend
rate, conversion rights, voting rights, rights and terms of
redemption, the redemption price or prices, the liquidation
preferences of any wholly unissued series of Preferred Stock, and
the number of shares constituting any such series and the
designation thereof, or any of them; and to increase or decrease
the number of shares of any series subsequent to the issue of
shares of that series, but not below the number of shares of such
series then outstanding. In case the number of shares of any series
shall be so decreased, the shares constituting such decrease shall
resume the status which they had prior to the adoption of the
resolution originally fixing the number of shares of such
series.
The particular terms of each class or series of preferred stock
that we may offer under this prospectus, including redemption
privileges, liquidation preferences, voting rights, dividend rights
and/or conversion rights, will be more fully described in the
applicable prospectus supplement relating to the preferred stock
offered thereby. The rights, preferences, privileges and
restrictions of the preferred stock of each series will be fixed by
the certificate of designation relating to each series. We will
incorporate by reference into the registration statement of which
this prospectus is a part the form of any certificate of
designation that describes the terms of the series of preferred
stock we are offering before the issuance of the related series of
preferred stock. The applicable prospectus supplement will specify
the terms of the series of preferred stock we may offer, including,
but not limited to:
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• |
the distinctive designation and the maximum number of shares in
the series; |
|
• |
the number of shares we are offering and purchase price per
share; |
|
• |
the liquidation preference, if any; |
|
• |
the terms on which dividends, if any, will be paid; |
|
• |
the voting rights, if any, on the shares of the series; |
|
• |
the terms and conditions, if any, on which the shares of the
series shall be convertible into, or exchangeable for, shares of
any other class or classes of capital stock; |
|
• |
the terms on which the shares may be redeemed, if at all; |
|
• |
any listing of the preferred stock on any securities exchange
or market; |
|
• |
a discussion of any material or special United States federal
income tax considerations applicable to the preferred stock;
and |
|
• |
any or all other preferences, rights, restrictions, including
restrictions on transferability, and qualifications of shares of
the series. |
The issuance of preferred stock may delay, deter or prevent a
change in control.
The description of preferred stock above and the description of the
terms of a particular series of preferred stock in any applicable
prospectus supplement are not complete. You should refer to the
applicable certificate of designation for complete information.
The DGCL provides that the holders of preferred stock will have the
right to vote separately as a class on any proposal involving
fundamental changes in the rights of holders of that preferred
stock. This right is in addition to any voting rights that may be
provided for in the applicable certificate of designation.
Possible Anti-Takeover Effects of Delaware Law and our
Certificate of Incorporation and By-laws
Authorized but Unissued Stock. We have shares of common
stock and preferred stock available for future issuance, in some
cases without stockholder approval. We may issue these additional
shares for a variety of corporate purposes, including public
offerings to raise additional capital, corporate acquisitions,
stock dividends on our capital stock or equity compensation plans.
The existence of unissued and unreserved common stock and preferred
stock may enable our Board to issue shares to persons friendly to
current management or to issue preferred stock with terms that
could render more difficult or discourage a third-party attempt to
obtain control of us, thereby protecting the continuity of our
management. In addition, if we issue preferred stock, the issuance
could adversely affect the voting power of holders of common stock
and the likelihood that such holders will receive dividend payments
and payments upon liquidation.
Amendments to By-laws. Our certificate of incorporation and
by-laws authorize the Board to amend, repeal, alter or rescind the
by-laws at any time without stockholder approval. Allowing the
Board to amend our by-laws without stockholder approval enhances
Board control over our by-laws.
Classification of Board; Removal of Directors; Vacancies.
Our certificate of incorporation provide for the division of the
Board into three classes as nearly equal in size as possible with
staggered three-year terms; that directors may be removed only for
cause by the affirmative vote of the holders of two-thirds of our
shares of capital stock entitled to vote; and that any vacancy on
the Board, however occurring, including a vacancy resulting from an
enlargement of the Board, may be filled only by the vote of a
majority of the directors then in office. The limitations on the
removal of directors and the filling of vacancies could have the
effect of making it more difficult for a third party to acquire, or
of discouraging a third party from acquiring, control of us. Our
certificate of incorporation requires the affirmative vote of the
holders of at least 75% of our shares of capital stock issued and
outstanding and entitled to vote to amend or repeal any of these
provisions.
Notice Periods for Stockholder Meetings. Our by-laws provide
that for business to be brought by a stockholder before an annual
meeting of stockholders, the stockholder must give written notice
to the corporation not less than 90 nor more than 120 days prior to
the one year anniversary of the date of the annual meeting of
stockholders of the previous year; provided, however, that in the
event that the annual meeting of stockholders is called for a date
that is not within 30 days before or after such anniversary date,
notice by the stockholder must be received not later than the close
of business on the tenth day following the day on which the
corporation's notice of the date of the meeting is first given or
made to the stockholders or disclosed to the general public,
whichever occurs first.
Stockholder Action; Special Meetings. Our certificate of
incorporation provides that stockholder action may not be taken by
written action in lieu of a meeting and provides special meetings
of the stockholders may only be called by our president or by our
Board. These provisions could have the effect of delaying until the
next stockholders' meeting stockholder actions that are favored by
the holders of a majority of our outstanding voting securities.
These provisions may also discourage another person or entity from
making a tender offer for our common stock, because that person or
entity, even if it acquired a majority of our outstanding voting
securities, would be able to take action as a stockholder only at a
duly called stockholders' meeting, and not by written consent. Our
certificate of incorporation requires the affirmative vote of the
holders of at least 75% of our shares of capital stock issued and
outstanding and entitled to vote to amend or repeal the provisions
relating to prohibition on action by written consent and the
calling of a special meeting of stockholders.
Nominations. Our by-laws provide that nominations for
election of directors may be made only by (i) the Board or a
committee appointed by the Board; or (ii) a stockholder
entitled to vote on director election, if the stockholder provides
notice to the Secretary of the Corporation presented not less than
90 days nor more than 120 days prior to the anniversary of the last
annual meeting (subject to the limited exceptions set forth in the
by-laws). These provisions may deter takeovers by requiring that
any stockholder wishing to conduct a proxy contest have its
position solidified well in advance of the meeting at which
directors are to be elected and by providing the incumbent Board
with sufficient notice to allow them to put an election strategy in
place.
Delaware Anti-Takeover Statute. We are subject to
Section 203 of the DGCL, an anti-takeover statute. In general,
Section 203 of the DGCL prohibits a publicly held Delaware
corporation from engaging in a “business combination” with an
“interested stockholder” for a period of three years following the
time the person became an interested stockholder, unless the
business combination or the acquisition of shares that resulted in
a stockholder becoming an interested stockholder is approved in a
prescribed manner. Generally, a “business combination” includes a
merger, asset or stock sale, or other transaction resulting in a
financial benefit to the interested stockholder. Generally, an
“interested stockholder” is a person who, together with affiliates
and associates, owns (or within three years prior to the
determination of interested stockholder status did own) 15% or more
of a corporation’s voting stock. The existence of this provision
would be expected to have an anti-takeover effect with respect to
transactions not approved in advance by our Board, including
discouraging attempts that might result in a premium over the
market price for the shares of common stock held by our
stockholders
The above provisions may deter a hostile takeover or delay a change
in control or management of us.
DESCRIPTION OF
WARRANTS
The following description, together with the additional information
we may include in any applicable prospectus supplements and free
writing prospectuses, summarizes the material terms and provisions
of the warrants that we may offer under this prospectus, which may
consist of warrants to purchase common stock or preferred stock and
may be issued in one or more series. Warrants may be offered
independently or together with common stock or preferred stock
offered by any prospectus supplement, and may be attached to or
separate from those securities. While the terms we have summarized
below will apply generally to any warrants that we may offer under
this prospectus, we will describe the particular terms of any
series of warrants that we may offer in more detail in the
applicable prospectus supplement and any applicable free writing
prospectus. The terms of any warrants offered under a prospectus
supplement may differ from the terms described below. However, no
prospectus supplement will fundamentally change the terms that are
set forth in this prospectus or offer a security that is not
registered and described in this prospectus at the time of its
effectiveness.
We will issue the warrants under a warrant agreement that we will
enter into with a warrant agent to be selected by us. The warrant
agent will act solely as an agent of ours in connection with the
warrants and will not act as an agent for the holders or beneficial
owners of the warrants. We will file as exhibits to the
registration statement of which this prospectus is a part the form
of warrant agreement, including a form of warrant certificate that
describes the terms of the particular series of warrants we are
offering before the issuance of the related series of warrants. The
following summaries of material provisions of the warrants and the
warrant agreements are subject to, and qualified in their entirety
by reference to, all the provisions of the warrant agreement and
warrant certificate applicable to a particular series of warrants.
We urge you to read the applicable prospectus supplement and any
applicable free writing prospectus related to the particular series
of warrants that we sell under this prospectus, as well as the
complete warrant agreements and warrant certificates that contain
the terms of the warrants.
The applicable prospectus supplement will specify the terms
relating to a series of warrants, including:
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• |
the offering price and aggregate number of warrants
offered; |
|
• |
if applicable, the designation and terms of the securities with
which the warrants are issued and the number of warrants issued
with each such security or each principal amount of such
security; |
|
• |
if applicable, the date on and after which the warrants and the
related securities will be separately transferable; |
|
• |
the number of shares of common stock or preferred stock, as the
case may be, purchasable upon the exercise of one warrant and the
price at which these shares may be purchased upon such
exercise; |
|
• |
the effect of any merger, consolidation, sale or other
disposition of our business on the warrant agreements and the
warrants; |
|
• |
the terms of any rights to redeem or call the warrants; |
|
• |
any provisions for changes to or adjustments in the exercise
price or number of securities issuable upon exercise of the
warrants; |
|
• |
the dates on which the right to exercise the warrants will
commence and expire; |
|
• |
the manner in which the warrant agreements and warrants may be
modified; |
|
• |
United States federal income tax consequences of holding or
exercising the warrants; |
|
• |
the terms of the securities issuable upon exercise of the
warrants; and |
|
• |
any other specific terms, preferences, rights or limitations of
or restrictions on the warrants. |
Before exercising their warrants, holders of warrants to purchase
common stock or preferred stock will not have any of the rights of
holders of the securities purchasable upon such exercise, including
the right to receive dividends, if any, or payments upon our
liquidation, dissolution or winding up or to exercise voting
rights, if any.
DESCRIPTION OF UNITS
The following description, together with the additional information
we may include in any applicable prospectus supplements and free
writing prospectuses, summarizes the material terms and provisions
of the units that we may offer under this prospectus. While the
terms we have summarized below will apply generally to any units
that we may offer under this prospectus, we will describe the
particular terms of any series of units in more detail in the
applicable prospectus supplement. The terms of any units offered
under a prospectus supplement may differ from the terms described
below. However, no prospectus supplement will fundamentally change
the terms that are set forth in this prospectus or offer a security
that is not registered and described in this prospectus at the time
of its effectiveness.
We will file as exhibits to the registration statement of which
this prospectus is a part the form of unit agreement that describes
the terms of the series of units we are offering, and any
supplemental agreements, before the issuance of the related series
of units. The following summaries of material terms and provisions
of the units are subject to, and qualified in their entirety by
reference to, all the provisions of the unit agreement and any
supplemental agreements applicable to a particular series of units.
We urge you to read the applicable prospectus supplements related
to the particular series of units that we sell under this
prospectus, as well as the complete unit agreement and any
supplemental agreements that contain the terms of the units.
We may issue units comprised of one or more shares of common stock,
shares of preferred stock and warrants in any combination. Each
unit will be issued so that the holder of the unit is also the
holder of each security included in the unit. Thus, the holder of a
unit will have the rights and obligations of a holder of each
included security. The unit agreement under which a unit is issued
may provide that the securities included in the unit may not be
held or transferred separately, at any time or at any time before a
specified date.
We will describe in the applicable prospectus supplement the terms
of the series of units, including:
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• |
the designation and terms of the units and of the securities
comprising the units, including whether and under what
circumstances those securities may be held or transferred
separately; |
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any provisions of the governing unit agreement that differ from
those described below; and |
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any provisions for the issuance, payment, settlement, transfer
or exchange of the units or of the securities comprising the
units. |
The provisions described in this section, as well as those
described under “Description of Capital Stock” and “Description of
Warrants” will apply to each unit and to any common stock,
preferred stock or warrant included in each unit, respectively.
DESCRIPTION OF SUBSCRIPTION
RIGHTS
The following description, together with the additional information
we may include in any applicable prospectus supplements and free
writing prospectuses, summarizes the material terms and provisions
of the subscription rights that we may offer under this prospectus.
While the terms we have summarized below will apply generally to
any subscription rights that we may offer under this prospectus, we
will describe the particular terms of any series of subscription
rights in more detail in the applicable prospectus supplement. The
terms of any subscription rights offered under a prospectus
supplement may differ from the terms described below. However, no
prospectus supplement will fundamentally change the terms that are
set forth in this prospectus or offer a security that is not
registered and described in this prospectus at the time of its
effectiveness.
We will file as exhibits to the registration statement of which
this prospectus is a part the form of subscription rights agreement
that describes the terms of the series of subscription rights we
are offering, and any supplemental agreements, before the issuance
of the related series of subscription rights. The following
summaries of material terms and provisions of the subscription
rights are subject to, and qualified in their entirety by reference
to, all the provisions of the subscription rights agreement and any
supplemental agreements applicable to a particular series of
subscription rights. We urge you to read the applicable prospectus
supplements related to the particular series of subscription rights
that we sell under this prospectus, as well as the complete
subscription rights agreement and any supplemental agreements that
contain the terms of the subscription rights.
We may issue subscription rights to purchase common stock,
preferred stock or other securities described in this prospectus or
any combination thereof. These subscription rights may be issued
independently or together with any other security offered by us and
may or may not be transferable by the holder receiving the
subscription rights in such offering. In connection with any
offering of subscription rights, we may enter into a standby
arrangement with one or more underwriters or other investors
pursuant to which the underwriters or other investors may be
required to purchase any securities remaining unsubscribed for
after such offering.
To the extent appropriate, the applicable prospectus supplement
will describe the specific terms of the subscription rights to
purchase shares of our securities offered thereby, including the
following:
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the date of determining the holders entitled to the rights
distribution; |
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the price, if any, for the subscription rights; |
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the exercise price payable for the common stock, preferred
stock or other securities upon the exercise of the subscription
right; |
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the number of subscription rights issued to each holder |
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the amount of common stock, preferred stock, or other
securities that may be purchased per each subscription right; |
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any provisions for adjustment of the amount of securities
receivable upon exercise of the subscription rights or of the
exercise price of the subscription rights; |
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the extent to which the subscription rights are
transferable; |
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the date on which the right to exercise the subscription rights
shall commence, and the date on which the subscription rights shall
expire; |
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the extent to which the subscription rights may include an
over-subscription privilege with respect to unsubscribed
securities; |
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the material terms of any standby underwriting or purchase
arrangement entered into by us in connection with the offering of
subscription rights; |
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any applicable federal income tax considerations; and |
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any other terms of the subscription rights, including the
terms, procedures and limitations relating to the transferability,
exchange and exercise of the subscription rights. |
PLAN OF DISTRIBUTION
We may sell the securities being offered hereby in one or more of
the following ways from time to time:
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through agents to the public or to investors; |
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to underwriters for resale to the public or to investors; |
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in "at the market" offerings, within the meaning of
Rule 415(a)(4) of the Securities Act, to or through a
market maker or into an existing trading market on an exchange or
otherwise; |
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directly to investors; or |
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through a combination of any of these methods of sale. |
We will set forth in a prospectus supplement the terms of the
particular offering of securities, including:
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the terms of the offering; |
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the name or names of any agents or underwriters; |
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the purchase price of the securities being offered and the
proceeds we will receive from the sale; |
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any over-allotment options under which underwriters may
purchase additional securities from us; |
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any agency fees or underwriting discounts and other items
constituting agents’ or underwriters’ compensation; |
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any initial public offering price; |
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any discounts or concessions allowed or reallowed or paid to
dealers; and |
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any securities exchanges or markets on which such securities
may be listed. |
We may issue to the holders of our common stock on a pro rata basis
for no consideration, subscription rights to purchase shares of our
common stock or preferred stock. These subscription rights may or
may not be transferable by stockholders. The applicable prospectus
supplement will describe the specific terms of any offering of our
common or preferred stock through the issuance of subscription
rights, including the terms of the subscription rights offering,
the terms, procedures and limitations relating to the exchange and
exercise of the subscription rights and, if applicable, the
material terms of any standby underwriting or purchase arrangement
entered into by us in connection with the offering of common or
preferred stock through the issuance of subscription rights.
Agents
We may designate agents who agree to use their reasonable efforts
to solicit purchases of our securities for the period of their
appointment or to sell our securities on a continuing basis.
Underwriters
If we use underwriters for a sale of securities, the underwriters
will acquire the securities for their own account. The underwriters
may resell the securities in one or more transactions, including
negotiated transactions, at a fixed public offering price or at
varying prices determined at the time of sale. The obligations of
the underwriters to purchase the securities will be subject to the
conditions set forth in the applicable underwriting agreement. The
underwriters will be obligated to purchase all the securities of
the series offered if they purchase any of the securities of that
series. We may change from time to time any initial public offering
price and any discounts or concessions the underwriters allow or
reallow or pay to dealers. We may use underwriters with whom we
have a material relationship. We will describe the nature of any
such relationship in any prospectus supplement naming any such
underwriter. Only underwriters we name in the prospectus supplement
are underwriters of the securities offered by the prospectus
supplement.
Direct Sales
We may also sell securities directly to one or more purchasers
without using underwriters or agents. Underwriters, dealers and
agents that participate in the distribution of the securities may
be underwriters as defined in the Securities Act, and any discounts
or commissions they receive from us and any profit on their resale
of the securities may be treated as underwriting discounts and
commissions under the Securities Act. We will identify in the
applicable prospectus supplement any underwriters, dealers or
agents and will describe their compensation. We may have agreements
with the underwriters, dealers and agents to indemnify them against
specified civil liabilities, including liabilities under the
Securities Act. Underwriters, dealers and agents may engage in
transactions with or perform services for us in the ordinary course
of their businesses.
Delayed Delivery Contracts
If the prospectus supplement indicates, we may authorize agents,
underwriters or dealers to solicit offers from certain types of
institutions to purchase securities at the public offering price
under delayed delivery contracts. These contracts would provide for
payment and delivery on a specified date in the future. The
contracts would be subject only to those conditions described in
the prospectus supplement. The applicable prospectus supplement
will describe the commission payable for solicitation of those
contracts.
Market Making, Stabilization and Other Transactions
Unless the applicable prospectus supplement states otherwise, each
series of offered securities will be a new issue and will have no
established trading market. We may elect to list any series of
offered securities on an exchange. Any underwriters that we use in
the sale of offered securities may make a market in such
securities, but may discontinue such market making at any time
without notice. Therefore, we cannot assure you that the securities
will have a liquid trading market.
Any underwriter may also engage in stabilizing transactions,
syndicate covering transactions and penalty bids in accordance with
Rule 104 under the Exchange Act. Stabilizing transactions
involve bids to purchase the underlying security in the open market
for the purpose of pegging, fixing or maintaining the price of the
securities. Syndicate covering transactions involve purchases of
the securities in the open market after the distribution has been
completed in order to cover syndicate short positions.
Penalty bids permit the underwriters to reclaim a selling
concession from a syndicate member when the securities originally
sold by the syndicate member are purchased in a syndicate covering
transaction to cover syndicate short positions. Stabilizing
transactions, syndicate covering transactions and penalty bids may
cause the price of the securities to be higher than it would be in
the absence of the transactions. The underwriters may, if they
commence these transactions, discontinue them at any time.
Passive Market Making
Any underwriters who are qualified market makers on the Nasdaq
Capital Market may engage in passive market making transactions in
the securities on the Nasdaq Capital Market in accordance with
Rule 103 of Regulation M, during the business day prior to the
pricing of the offering, before the commencement of offers or sales
of the securities. Passive market makers must comply with
applicable volume and price limitations and must be identified as
passive market makers. In general, a passive market maker must
display its bid at a price not in excess of the highest independent
bid for such security. If all independent bids are lowered below
the passive market maker’s bid, however, the passive market maker’s
bid must then be lowered when certain purchase limits are
exceeded.
Derivative Transactions and Hedging
We, the underwriters or other agents may engage in derivative
transactions involving the securities. These derivatives may
consist of short sale transactions and other hedging activities.
The underwriters or agents may acquire a long or short position in
the securities, hold or resell securities acquired and purchase
options or futures on the securities and other derivative
instruments with returns linked to or related to changes in the
price of the securities. In order to facilitate these derivative
transactions, we may enter into security lending or repurchase
agreements with the underwriters or agents. The underwriters or
agents may effect the derivative transactions through sales of the
securities to the public, including short sales, or by lending the
securities in order to facilitate short sale transactions by
others. The underwriters or agents may also use the securities
purchased or borrowed from us or others (or, in the case of
derivatives, securities received from us in settlement of those
derivatives) to directly or indirectly settle sales of the
securities or close out any related open borrowings of the
securities.
Electronic Auctions
We may also make sales through the Internet or through other
electronic means. Since we may from time to time elect to offer
securities directly to the public, with or without the involvement
of agents, underwriters or dealers, utilizing the Internet or other
forms of electronic bidding or ordering systems for the pricing and
allocation of such securities, you will want to pay particular
attention to the description of that system we will provide in a
prospectus supplement.
Such electronic system may allow bidders to directly participate,
through electronic access to an auction site, by submitting
conditional offers to buy that are subject to acceptance by us, and
which may directly affect the price or other terms and conditions
at which such securities are sold. These bidding or ordering
systems may present to each bidder, on a so-called “real-time”
basis, relevant information to assist in making a bid, such as the
clearing spread at which the offering would be sold, based on the
bids submitted, and whether a bidder’s individual bids would be
accepted, prorated or rejected.
Upon completion of such an electronic auction process, securities
will be allocated based on prices bid, terms of bid or other
factors. The final offering price at which securities would be sold
and the allocation of securities among bidders would be based in
whole or in part on the results of the Internet or other electronic
bidding process or auction.
General Information
Agents, underwriters, and dealers may be entitled, under agreements
entered into with us, to indemnification by us against certain
liabilities, including liabilities under the Securities Act. Our
agents, underwriters, and dealers, or their affiliates, may be
customers of, engage in transactions with or perform services for
us, in the ordinary course of business.
The maximum consideration or discount to be received by any
Financial Industry Regulatory Authority, or FINRA, member or
independent broker dealer may not exceed 8.0% of the aggregate
amount of the securities offered pursuant to this prospectus and
any applicable prospectus supplement.
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.
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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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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obtain a copy from the SEC upon payment of the fees prescribed
by the SEC. |
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