As filed with the Securities and Exchange Commission
on August 11, 2020
Registration No.
333-
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
|
Washington, D.C.
20549 |
|
FORM S-3 |
REGISTRATION STATEMENT UNDER THE
SECURITIES ACT OF 1933 |
|
CELLECTAR
BIOSCIENCES, INC. |
(Exact name of registrant as
specified in its charter) |
|
Delaware |
|
2834 |
|
04-3321804 |
(State or other jurisdiction of
incorporation or organization) |
|
(Primary Standard Industrial
Classification Code Number) |
|
(I.R.S. Employer Identification
No.) |
|
100 Campus Drive |
Florham Park, New Jersey 07932
Telephone (608) 441-8120 |
(Address, including zip code and
telephone number, including area code, of registrant’s principal
executive offices) |
|
James V. Caruso
President and Chief Executive Officer |
100 Campus Drive |
Florham Park, New Jersey
07932 |
Telephone (608)
441-8120 |
(Name, address, including zip code
and telephone number, including area code, of agent for
service) |
|
With copies to: |
Gregory J.
Lynch, Esq. |
Joshua B.
Erekson, Esq. |
Michael Best & Friedrich
LLP |
One South Pinckney Street,
Suite 700 |
Madison, Wisconsin
53703 |
(608) 257-3501 |
|
From time to time after the
effectiveness of this registration statement. |
(Approximate date of commencement of
proposed sale to the public) |
If the only securities being registered on this Form are being
offered pursuant to dividend or interest reinvestment plans, please
check the following box. ¨
If any of the securities being registered on this Form are to
be offered on a delayed or continuous basis pursuant to
Rule 415 under the Securities Act of 1933, other than
securities offered only in connection with dividend or interest
reinvestment plans, check the following box. x
If this Form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities
Act, please check the following box and list the Securities Act
registration statement number of the earlier effective registration
statement for the same offering. ¨
If this Form is a post-effective amendment filed pursuant to
Rule 462(c) under the Securities Act, check the following
box and list the Securities Act registration statement number of
the earlier effective registration statement for the same offering.
¨
If this Form is a registration statement pursuant to General
Instruction I.D. or a post-effective amendment thereto that shall
become effective upon filing with the Commission pursuant to
Rule 462(e) under the Securities Act, check the following
box. ¨
If this Form is a post-effective amendment to a registration
statement filed pursuant to General Instruction I.D. filed to
register additional securities or additional classes of securities
pursuant to Rule 413(b) under the Securities Act, check
the following box. ¨
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, a
smaller reporting company, or an emerging growth company. See the
definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company” and “emerging growth company” in
Rule 12b-2 of the Exchange Act.
Large accelerated filer |
¨ |
Accelerated filer |
¨ |
Non-accelerated
filer |
x |
Smaller reporting company |
x |
|
|
Emerging growth company |
¨ |
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided to Section 7(a)(2)(B) of the
Securities Act. ¨
CALCULATION OF REGISTRATION FEE
Title of Each Class of
Securities to be Registered(1) |
|
Amount to be
Registered(1) |
|
|
Proposed
Maximum
Offering
Price Per
Security(1) |
|
|
Proposed
Maximum
Aggregate
Offering
Price(1) |
|
|
Amount of
Registration
Fee(1)(4) |
|
Common Stock, par value $0.00001 per
share(2) |
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
Preferred Stock, par value $0.00001
per share(2) |
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
Warrants |
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
Units of the securities listed above |
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
Subscription
Rights(3) |
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
Total |
|
|
|
|
|
|
|
|
|
$ |
100,000,000 |
|
|
$ |
12,980 |
|
|
(1) |
An indeterminate aggregate initial offering price
or number of securities of each identified class is being
registered as may from time to time be offered at indeterminate
prices, with an aggregate initial offering price not to exceed
$100,000,000. Pursuant to Rule 416 under the Securities Act of
1933, as amended (the “Securities Act”), there is also being
registered such indeterminable number of additional shares of
common stock, preferred stock, warrants, units and subscription
rights as may be issued to prevent dilution resulting from share
dividends, split-up, reverse split-up or similar events. Separate
consideration may or may not be received for securities that are
issuable on exercise, conversion or exchange of other securities or
that are issued in unit. |
|
(2) |
Includes an indeterminate number of shares of
common stock or preferred stock as may be sold from time to time at
indeterminate prices or as may be issued upon conversion or
exchange of preferred stock, warrants, units or subscription rights
registered hereby. |
|
(3) |
Rights evidencing the right to purchase common
stock or preferred stock. Pursuant to Rule 457(g), no separate
registration fee is payable with respect to the subscription rights
being offered hereby since the subscription rights are being
registered in the same registration statement as the securities to
be offered pursuant thereto. |
|
(4) |
Calculated pursuant to
Rule 457(o) under the Securities Act. |
The registrant hereby amends this registration statement on such
date or dates as may be necessary to delay its effective date until
the registrant files a further amendment that specifically states
that this registration statement will thereafter become effective
in accordance with Section 8(a) of the Securities Act of
1933 or until the registration statement becomes effective on such
date as the Securities and Exchange Commission, acting pursuant to
Section 8(a), may determine.
The information in this prospectus is not complete and may be
changed. We may not sell these securities until the registration
statement filed with the Securities and Exchange Commission (the
“SEC”) is effective. This prospectus is 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 is not
permitted.
SUBJECT TO COMPLETION, DATED AUGUST 11, 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:
|
· |
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. |
|
|
|
|
· |
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. |
|
|
|
|
· |
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. |
|
· |
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:
|
· |
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. |
|
· |
You may experience future dilution as a result of future equity
offerings. |
|
· |
Warrants issued in this offering may not have any value. |
|
· |
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. |
|
· |
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:
|
• |
designation or classification; |
|
• |
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:
|
• |
the names of those underwriters or agents; |
|
• |
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:
|
· |
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:
|
• |
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:
|
• |
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:
|
• |
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; |
|
• |
any provisions of the governing unit agreement that differ from
those described below; and |
|
• |
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:
|
• |
the date of determining the holders entitled to the rights
distribution; |
|
• |
the price, if any, for the subscription rights; |
|
• |
the exercise price payable for the common stock, preferred
stock or other securities upon the exercise of the subscription
right; |
|
• |
the number of subscription rights issued to each holder |
|
• |
the amount of common stock, preferred stock, or other
securities that may be purchased per each subscription right; |
|
• |
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; |
|
• |
the extent to which the subscription rights are
transferable; |
|
• |
the date on which the right to exercise the subscription rights
shall commence, and the date on which the subscription rights shall
expire; |
|
• |
the extent to which the subscription rights may include an
over-subscription privilege with respect to unsubscribed
securities; |
|
• |
the material terms of any standby underwriting or purchase
arrangement entered into by us in connection with the offering of
subscription rights; |
|
• |
any applicable federal income tax considerations; and |
|
• |
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:
|
• |
through agents to the public or to investors; |
|
• |
to underwriters for resale to the public or to investors; |
|
• |
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; |
|
• |
directly to investors; or |
|
• |
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:
|
• |
the terms of the offering; |
|
• |
the name or names of any agents or underwriters; |
|
• |
the purchase price of the securities being offered and the
proceeds we will receive from the sale; |
|
• |
any over-allotment options under which underwriters may
purchase additional securities from us; |
|
• |
any agency fees or underwriting discounts and other items
constituting agents’ or underwriters’ compensation; |
|
• |
any initial public offering price; |
|
• |
any discounts or concessions allowed or reallowed or paid to
dealers; and |
|
• |
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:
|
· |
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, is not part of this prospectus.
INCORPORATION OF DOCUMENTS BY
REFERENCE
The SEC allows us to “incorporate by reference” information into
this prospectus. This means that we can disclose important
information to you by referring you to another document filed
separately with the SEC. The information incorporated by reference
is considered to be a part of this prospectus, except for any
information that is superseded by other information that is
included in this prospectus.
We incorporate by reference into this prospectus the following
document, which we have previously filed with the SEC:
In addition, all documents subsequently filed by us pursuant to
Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act prior
to the termination of the offering will be deemed to be
incorporated by reference into this prospectus.
You should rely only on the information contained in this
prospectus, as updated and supplemented by any prospectus
supplement, or that information to which this prospectus or any
prospectus supplement has referred you by reference. We have not
authorized anyone to provide you with any additional
information.
Any statement contained in a document incorporated or deemed to be
incorporated by reference herein will be deemed to be modified or
superseded for purposes of this prospectus to the extent that a
statement contained herein modifies or supersedes such statement.
Any statement so modified or superseded will not be deemed, except
as so modified or superseded, to constitute a part of this
prospectus.
You may request and obtain a copy of any of the filings
incorporated herein by reference, at no cost, by writing or
telephoning us at the following address or phone number:
Cellectar Biosciences, Inc.
100 Campus Drive
Florham Park, New Jersey 07932
Attention: Chief Financial Officer (608) 441-8120

CELLECTAR BIOSCIENCES, INC.
$100,000,000
Common Stock
Preferred Stock
Warrants
Units
Subscription Rights
PROSPECTUS
August ,
2020
The information in this prospectus is not complete and may be
changed. We may not sell these securities until the Registration
Statement filed with the Securities and Exchange Commission is
effective. This prospectus is not an offer to sell these securities
and is not soliciting an offer to buy these securities in any state
where the offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED AUGUST 11, 2020
PROSPECTUS SUPPLEMENT

CELLECTAR BIOSCIENCES, INC.
$14,500,000
Common Stock
We have entered into an Equity Distribution Agreement (“Sales
Agreement”) with Oppenheimer & Co. Inc. (the “Sales
Agent”) relating to shares of our common stock offered by this
prospectus. In accordance with the terms of the Sales Agreement, we
may offer and sell shares of our common stock having an aggregate
offering price of up to $14,500,000 from time to time through the
Sales Agent acting as agent.
Our common stock is traded on the Nasdaq Capital Market under the
symbol CLRB. On August 7, 2020, the last reported sale price for
our common stock was $1.40 per share. The aggregate market value of
our outstanding common stock held by non-affiliates, or public
float, as of the date of this prospectus is approximately $43.9
million based on 26,424,893 shares of outstanding common stock held
by non-affiliates, and a per share price of $1.66, which was the
last reported sale price of our common stock on
the Nasdaq Capital Market on July 30, 2020 (a date within
60 days of the date hereof). Pursuant to General Instruction I.B.6
of Form S-3, in no event will we sell securities registered on the
registration statement of which this prospectus is a part in a
public primary offering with a value exceeding more than one-third
of our public float in any 12-month period if our public float,
measured in accordance with such instruction, remains below $75.0
million. As of the date hereof, we have not offered any securities
pursuant to General Instruction I.B.6 of Form S-3 during the 12
calendar months prior to and including the date of this
prospectus.
Sales of our common stock, if any, under this prospectus may be
made in sales deemed to be “at the market offerings” as defined in
Rule 415 promulgated under the Securities Act of 1933, as
amended (the “Securities Act”), or in privately negotiated
transactions. The Sales Agent is not required to sell any specific
number or dollar amount of securities, but will act as a sales
agent, using commercially reasonable efforts consistent with its
normal trading and sales practices, on mutually agreed terms
between the Sales Agent and us. There is no arrangement for funds
to be received in any escrow, trust or similar arrangement.
The compensation to the Sales Agent for sales of common stock sold
pursuant to the Sales Agreement will be an amount equal to 3.0% of
the gross proceeds of any shares of common stock sold under the
Sales Agreement. See “Plan of Distribution” of this Prospectus for
additional information regarding the Sales Agent’s compensation. In
connection with the sale of the common stock on our behalf, the
Sales Agent will be deemed to be an “underwriter” within the
meaning of the Securities Act and the compensation of the Sales
Agent will be deemed to be underwriting commissions or discounts.
We have also agreed to provide indemnification and contribution to
the Sales Agent with respect to certain liabilities, including
liabilities under the Securities Act and the Exchange Act of 1934,
as amended (Exchange Act).
INVESTING IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK.
YOU SHOULD REVIEW CAREFULLY THE RISKS AND UNCERTAINTIES DESCRIBED
UNDER THE HEADING “RISK FACTORS” OF THIS PROSPECTUS, AND UNDER
SIMILAR HEADINGS IN THE DOCUMENTS THAT ARE INCORPORATED BY
REFERENCE INTO THIS PROSPECTUS AND THE ACCOMPANYING
PROSPECTUS.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus and the accompanying
prospectus are truthful or complete. Any representation to the
contrary is a criminal offense.
Oppenheimer & Co.
The date of this prospectus
is
, 2020.
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
This prospectus relates to part of a registration statement on
Form S-3 that we filed with the Securities and Exchange
Commission, or SEC, utilizing a “shelf” registration process. Under
this shelf registration process, we may sell any combination of the
securities described in our base prospectus included in the shelf
registration statement in one or more offerings up to a total
aggregate offering price of $100,000,000. The $14,500,000 shares of
common stock that may be offered, issued and sold under this
prospectus is included in the $100,000,000 of securities that may
be offered, issued and sold by us pursuant to our shelf
registration statement.
This prospectus relates to the offering of shares of our common
stock. Before buying any of the common stock that we are offering,
we urge you to carefully read this prospectus, together with the
information incorporated by reference as described under the
headings “Where You Can Find Additional Information” and
“Incorporation of Certain Information by Reference” in this
prospectus. These documents contain important information that you
should consider when making your investment decision.
This document is in two parts. The first part is this prospectus
supplement, which describes the specific terms of this offering of
our common stock and also adds, updates and changes information
contained in the accompanying prospectus and the documents
incorporated by reference. The second part is the accompanying base
prospectus, which gives more general information, some of which may
not apply to this offering of our common stock. To the extent the
information contained in this prospectus supplement differs or
varies from the information contained in the accompanying
prospectus or any document filed prior to the date of this
prospectus supplement and incorporated by reference, the
information in this prospectus supplement will control. Generally,
when we refer to this “prospectus,” we are referring to both
documents combined, together with any free writing prospectus that
we have authorized for use in connection with this offering.
You should rely only on the information contained in or
incorporated by reference in this prospectus and in any free
writing prospectus that we have authorized for use in connection
with this offering. We have not, and the Sales Agent has not,
authorized anyone to provide you with different information. If
anyone provides you with different or inconsistent information, you
should not rely on it. We are not, and the Sales Agent is not,
making an offer to sell these securities in any jurisdiction where
the offer or sale is not permitted. You should assume that the
information appearing in this prospectus, the documents
incorporated by reference in this prospectus, and in any free
writing prospectus that we have authorized for use in connection
with this offering, is accurate only as of the date of those
respective documents. Our business, financial condition, results of
operations and prospects may have changed since those dates. You
should read this prospectus, the documents incorporated by
reference in this prospectus, and any free writing prospectus that
we have authorized for use in connection with this offering, in
their entirety before making an investment decision.
The representations, warranties, and covenants made by us in any
agreement that is filed as an exhibit to any document that is
incorporated by reference into this prospectus supplement or the
accompanying prospectus were made solely for the benefit of the
parties to such agreement, including, in some cases, for the
purpose of allocating risk among the parties to such agreements,
and should not be deemed to be a representation, warranty or
covenant to you. Moreover, such representations, warranties or
covenants were accurate only as of the date when made. Accordingly,
such representations, warranties and covenants should not be relied
on as accurately representing the current state of our affairs.
CAUTIONARY NOTE REGARDING
FORWARD-LOOKING STATEMENTS
This prospectus, including the documents that we incorporate by
reference, contains forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933, as amended (the
“Securities Act”), and Section 21E of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”). Examples of our
forward-looking statements include:
|
· |
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.
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:
|
· |
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. |
|
|
|
|
· |
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. |
|
|
|
|
· |
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. |
|
· |
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:
|
· |
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. |
|
· |
You may experience future dilution as a result of future equity
offerings. |
more information regarding the material risks and uncertainties we
face, please see “Risk Factors” beginning on page S-14 of this
prospectus.
Corporate Information
Our principal executive offices are located at 100 Campus Drive,
Florham Park, New Jersey 07932 and the telephone number of our
principal executive offices is (608) 441-8120. We maintain a
website at www.cellectar.com. The information included or referred
to on, or accessible through, our website does not constitute part
of, and is not incorporated by reference into, this prospectus.
The Offering
The following is a brief summary of some of the terms of the
offering and is qualified in its entirety by reference to the more
detailed information appearing elsewhere in this prospectus. For a
more complete description of the terms of our common stock, see the
“Description of the Securities We Are Offering” section in this
prospectus.
Common stock
offered by us: |
Shares of our common stock having an
aggregate offering price of up to $14,500,000; the specific amount
of the offering shall be at the Company’s sole discretion. |
|
|
Manner of Offering: |
“At the market offering” that may be made from time to time
through our agent, the Sales Agent. See “Plan of
Distribution.” |
|
|
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-14 and the other
information included in this prospectus for a discussion of factors
you should carefully consider before deciding whether to purchase
our securities. |
|
|
Nasdaq symbol for our common stock: |
CLRB |
RISK FACTORS
An investment in our securities involves a high degree of risk.
Prior to making a decision about investing in our securities,
prospective investors should consider carefully all of the
information included and incorporated by reference or deemed to be
incorporated by reference in this prospectus, including the risk
factors incorporated by reference herein from our Annual Report on Form 10-K for
the fiscal year ended December 31, 2019, as updated by
annual, quarterly and other reports and documents we file with the
SEC after the date of this prospectus and that are incorporated by
reference herein or in the applicable prospectus supplement. Each
of these risk factors could have a material adverse effect on our
business, results of operations, financial position or cash flows,
which may result in the loss of all or part of your investment. For
more information, see “Where You Can Find Additional Information”
and “Incorporation of Certain Information by Reference.”
In addition, you should carefully consider the following risks
related to this offering, together with the other information about
these risks contained in this prospectus, as well as the other
information contained in this prospectus generally, before deciding
to buy our securities. Any of the risks we describe below could
adversely affect our business, financial condition, operating
results, or prospects. The market price for our securities could
decline if one or more of these risks and uncertainties develop
into actual events and you could lose all or part of your
investment. Additional risks and uncertainties that we do not yet
know of, or that we currently think are immaterial, may also impair
our business operations.
RISKS RELATED TO THIS OFFERING
We have broad discretion to determine how to use the proceeds
raised in this offering, and we may not use the proceeds
effectively.
The net proceeds from this offering will be immediately available
to our management to use at its discretion. We currently intend to
use the net proceeds from this offering to fund our research and
development activities, general corporate purposes, and possibly
for acquisitions of other companies, products or technologies,
although no such acquisitions are currently contemplated. See “Use
of Proceeds.” We have not allocated specific amounts of the net
proceeds from this offering for any of the foregoing purposes.
Accordingly, our management will have significant discretion and
flexibility in applying the net proceeds of this offering. You will
be relying on the judgment of our management with regard to the use
of these net proceeds, and you will not have the opportunity, as
part of your investment decision, to assess whether the proceeds
are being used appropriately. It is possible that the net proceeds
will be invested in a way that does not yield a favorable, or any,
return for us or our stockholders. The failure of our management to
use such funds effectively could have a material adverse effect on
our business, prospects, financial condition and results of
operation.
Sales of a substantial number of our common stock, or the
perception that such sales might occur, could adversely affect the
trading price of our common stock.
We may issue up to $14,500,000 shares of common stock from time to
time in this offering. Sales of a substantial number of our common
stock, or the perception that such sales might occur, could
adversely affect the trading price of our common stock. We cannot
predict the effect, if any, that market sales of those common stock
or the availability of those shares of common stock for sale will
have on the market price of our common stock. In addition, the
market price of our common stock could fall as a result of resales
of any of these common stock due to an increased number of shares
available for sale in the market.
You may experience immediate dilution in the book value per
share of the common stock you purchase.
Because the price per share of our common stock being offered may
be substantially higher than the book value per share of our common
stock, you may experience substantial dilution in the net tangible
book value of the common stock you purchase in this offering.
Assuming that an aggregate of 10,357,143 common stock are sold at a
price of $1.40 per share pursuant to this prospectus, which was the
last reported sale price of our common stock on the Nasdaq Capital
Market on August 7, 2020, and based on the net tangible book value
of the common stock of $0.78 per share as of June 30, 2020, if you
purchase common stock in this offering, you will experience
dilution of $0.45 per share in the net tangible book value of the
common stock.
You may experience future dilution as a result of future
equity offerings.
In order to raise additional capital, in the future we may offer
additional shares of our common stock or other securities
convertible into or exchangeable for our common stock at prices
that may not be the same as the price in this offering. We may sell
shares or other securities in any other offering at a price that is
less than the price paid by investors in this offering, and
investors purchasing shares or other securities in the future could
have rights superior to existing stockholders. The price at which
we sell additional shares of our common stock, or securities
convertible or exchangeable into common stock, in future
transactions may be higher or lower than the price paid by
investors in this offering.
It is not possible to predict the actual number of shares we
will sell under the Sales Agreement or the gross proceeds resulting
from those sales.
Subject to certain limitations in the Sales Agreement and
compliance with applicable law, we have the discretion to deliver a
placement notice to the Sales Agent at any time throughout the term
of the Sales Agreement. The number of shares that are sold through
the Sales Agent after delivering a placement notice will fluctuate
based on a number of factors, including the market price of our
common stock during the sales period, the limits we set with the
Sales Agent in any applicable placement notice, and the demand for
our common stock during the sales period. Because the price per
share of each share sold will fluctuate during the sales period, it
is not currently possible to predict the number of shares that will
be sold or the gross proceeds to be raised in connection with those
sales.
Our common stock offered hereby will be sold in “at the
market offerings,” and investors who buy shares at different times
will likely pay different prices.
Investors who purchase shares in this offering at different times
will likely pay different prices, and so may experience different
levels of dilution and different outcomes in their investment
results. We will have discretion, subject to market demand, to vary
the timing, prices, and numbers of shares sold in this offering. In
addition, there is no minimum or maximum sales price for shares to
be sold in this offering. Investors may experience a decline in the
value of the shares they purchase in this offering as a result of
sales made at prices lower than the prices they paid.
USE OF PROCEEDS
We may issue and sell shares of our common stock having aggregate
sales proceeds of up to $14,500,000 from time to time. Because
there is no minimum offering amount required as a condition to
close this offering, the actual total public offering amount,
commissions and proceeds to us, if any, are not determinable at
this time. There can be no assurance that we will sell any shares
under or fully utilize the Sales Agreement with the Sales Agent as
a source of financing.
We expect to use any proceeds received from this offering as
follows:
|
· |
research and development activities, including the further
development of CLR 131, and the research advancement of our PDC
platform, including product candidates, CLR 1700, CLR 1800, CLR
1900, CLR 2000, CLR 2100, CLR 2200 series and CLR 12120. |
|
· |
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 June 30, 2020, was
approximately $20 million, or $0.78 per share of common stock,
based upon 25,472,383 shares outstanding. Net tangible book value
per share is determined by dividing such number of outstanding
shares of common stock into our net tangible book value, which is
our total tangible assets, less total liabilities.
After giving effect to the
sale of an estimated 10,357,143 shares of our common stock in this
offering at the assumed offering price of $1.40 per share, the last reported sale price
of our common stock on the Nasdaq Capital Market
on August 7, 2020, gross proceeds will be
approximately $14.5 million. After deducting the underwriting
commission and our estimated offering expenses, our as-adjusted net
tangible book value as of June 30, 2020 would have been $0.95
per share. This represents an
immediate increase in net tangible book value of approximately
$0.17 per share to our existing stockholders, and an immediate
dilution of $0.45 per share to investors purchasing securities in
the offering.
The following table illustrates the per share dilution to investors
purchasing securities in the offering:
Assumed public offering
price per share of common stock |
|
|
|
|
|
$ |
1.40 |
|
Net
tangible book value per share as of June 30, 2020 |
|
$ |
0.78 |
|
|
|
|
|
Increase per share attributable to the sale of securities to
investors |
|
$ |
0.17 |
|
|
|
|
|
Adjusted net tangible book value per share after the offering |
|
|
|
|
|
$ |
0.95 |
|
Dilution per share to investors in this offering |
|
|
|
|
|
$ |
0.45 |
|
The dilution information set forth in the table above is
illustrative only and will be adjusted based on the actual sales
made during this offering. The information set forth above is based
on shares of common stock outstanding as of June 30, 2020 and
excludes, as of August 7, 2020:
|
· |
an aggregate of 1,154,250 shares of common stock issued upon
the exercise of outstanding warrants and pre-funded warrants issued
since June 30, 2020; |
|
· |
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 17,937,766 additional shares of common stock
reserved for issuance under outstanding warrants having expiration
dates between October 1, 2020, and June 5, 2025, and exercise
prices ranging from $1.21 to $283.00 per share; and |
|
· |
an aggregate of 186,960 additional
shares of common stock reserved for issuance under outstanding
pre-funded warrants with no expiration date and an exercise price
of $0.00001 per share. |
DESCRIPTION OF THE
SECURITIES WE ARE OFFERING
The following summary description of our common stock is based
on the provisions of our Second Amended and Restated Certificate of
Incorporation, as amended, which we refer to as our certificate of
incorporation or charter, our by-laws, and the applicable
provisions of the Delaware General Corporation Law, which we refer
to as the DGCL. This description may not contain all of the
information that is important to you and is subject to, and is
qualified in its entirety by reference to, our certificate of
incorporation, our by-laws and the applicable provisions of the
DGCL. For information on how to obtain copies of our certificate of
incorporation and by-laws, see “Where You Can Find More
Information.”
Authorized and Outstanding Capital Stock
Our authorized capital stock consists of 80,000,000 shares of
common stock, $0.00001 par value per share and 7,000 shares of
preferred stock, $0.00001 par value per share. Our certificate of
incorporation, as amended, authorizes us to issue shares of our
preferred stock from time to time in one or more series without
stockholder approval, each such series to have rights and
preferences, including voting rights, dividend rights, conversion
rights, redemption privileges and liquidation preferences, as our
Board may determine. The rights of the holders of common stock will
be subject to, and may be adversely affected by, the rights of
holders of any preferred stock that we may issue in the future. The
issuance of preferred stock, while providing desirable flexibility
in connection with possible acquisitions and other corporate
purposes, could have the effect of making it more difficult for
others to acquire, or of discouraging others from attempting to
acquire, a majority of our outstanding voting stock.
As of August 7, 2020, there were 26,626,633 shares of common stock
outstanding and 215 shares of preferred stock outstanding. All
outstanding shares of our common stock and preferred stock are duly
authorized, validly issued, fully paid and nonassessable.
Common Stock
Voting. Holders of our common stock are
entitled to one vote per share held of record on all matters to be
voted upon by our stockholders. Our common stock does not have
cumulative voting rights. Persons who hold a majority of the
outstanding common stock entitled to vote on the election of
directors can elect all of the directors who are eligible for
election.
Dividends. Subject to preferences that
may be applicable to the holders of any outstanding shares of our
preferred stock, the holders of our common stock are entitled to
receive such lawful dividends as may be declared by our Board.
Liquidation and Dissolution. In the event
of our liquidation, dissolution or winding up, and subject to the
rights of the holders of any outstanding shares of our preferred
stock, the holders of shares of our common stock will be entitled
to receive pro rata all of our remaining assets available for
distribution to our stockholders.
Other Rights and Restrictions. Our
charter prohibits us from granting preemptive rights to any of our
stockholders.
PLAN OF
DISTRIBUTION
We have entered into the Equity Distribution Agreement, or the
Sales Agreement, with the Sales Agent, under which we may issue and
sell from time to time shares of our common stock having an
aggregate offering price of not more than $14,500,000 through the
Sales Agent as our sales agent. Sales of the common stock, if any,
will be made by any method permitted by law deemed to be an “at the
market offering” as defined in Rule 415 promulgated under the
Securities Act, or in privately negotiated transactions. The Sales
Agreement has been filed as an exhibit to a Current Report on
Form 8-K and incorporated by reference into this prospectus
and the accompanying prospectus.
The Sales Agent will offer our common stock at prevailing market
prices subject to the terms and conditions of the Sales Agreement
as agreed upon by us and the Sales Agent. We will designate the
number of shares which we desire to sell, the time period during
which sales are requested to be made, any limitation on the number
of shares that may be sold in one day and any minimum price below
which sales may not be made. Subject to the terms and conditions of
the Sales Agreement, the Sales Agent will use its commercially
reasonable efforts, consistent with its sales and trading
practices, to sell on our behalf all of the shares of common stock
requested to be sold by us. We or the Sales Agent may suspend the
offering of the common stock being made through the Sales Agent
under the Sales Agreement upon proper notice to the other
party.
Unless otherwise specified in the applicable placement notice,
settlement for sales of our common stock will occur on the second
trading day (or such earlier day as is industry practice for
regular-way trading) following the time at which an acquiror of
common stock entered into a contract, binding upon such acquiror,
to acquire such common stock, in return for payment of the net
proceeds to us. There is no arrangement for funds to be received in
an escrow, trust or similar arrangement.
We will pay the Sales Agent in cash, upon each sale of our shares
of common stock pursuant to the Sales Agreement, a commission equal
to 3.0% of the gross proceeds from each sale of shares of our
common stock. Because there is no minimum offering amount required
as a condition to this offering, the actual total public offering
amount, commissions and proceeds to us, if any, are not
determinable at this time. Pursuant to the terms of the Sales
Agreement, we agreed to reimburse the Sales Agent for the fees and
disbursements of its counsel in an amount not to exceed
(i) $50,000 in connection with the establishment of the
at-the-market offering, and (ii) thereafter, $2,500 on a
quarterly basis. We estimate that the total expenses of the
offering payable by us, excluding commissions payable to the Sales
Agent under the Sales Agreement, will be approximately $60,000. We
will report at least quarterly the number of shares of common stock
sold through the Sales Agent under the Sales Agreement, the net
proceeds to us and the compensation paid by us to the Sales Agent
in connection with the sales of common stock.
In connection with the sales of common stock on our behalf, the
Sales Agent will be deemed to be an “underwriter” within the
meaning of the Securities Act, and the compensation paid to the
Sales Agent will be deemed to be underwriting commissions or
discounts. We have agreed in the Sales Agreement to provide
indemnification and contribution to the Sales Agent against certain
liabilities, including liabilities under the Securities Act and the
Exchange Act.
The offering of our shares of common stock pursuant to the Sales
Agreement will terminate upon the earlier of the (i) sale of
all of our shares of common stock provided for in this prospectus,
or (ii) termination of the Sales Agreement as permitted
therein.
The Sales Agent and its affiliates may in the future provide
various investment banking and other financial services for us and
our affiliates, for which services they may in the future receive
customary fees. To the extent required by Regulation M, the Sales
Agent will not engage in any market making activities involving our
shares of common stock while the offering is ongoing under this
prospectus. This summary of the material provisions of the Sales
Agreement does not purport to be a complete statement of its terms
and conditions. We are filing a copy of the Sales Agreement with
the SEC on a Current Report on Form 8-K concurrently with the
filing of this prospectus.
Other Relationships
Stefan D. Loren, Ph.D. began serving as director of Cellectar in
June 2015. Dr. Loren is currently a managing director
with Oppenheimer & Co. Inc. in its healthcare investment
banking group. Dr. Loren did not participate in the offering
on behalf of the Company or Oppenheimer & Co. Inc.
LEGAL MATTERS
The validity of the securities being offered by this prospectus has
been passed upon for us by Michael Best & Friedrich LLP,
Madison, Wisconsin. Ellenoff Grossman & Schole LLP, New
York, New York, is acting as counsel to the underwriter in this
offering.
EXPERTS
The audited financial statements incorporated by reference in this
prospectus and elsewhere in the registration statement have been so
incorporated by reference in reliance upon the report of Baker
Tilly US, LLP, independent registered public accountants, upon the
authority of said firm as experts in accounting and auditing.
WHERE YOU CAN FIND MORE
INFORMATION
We are a reporting company and file annual, quarterly and special
reports, and other information with the SEC. Copies of the reports
and other information may be read and copied at the SEC’s Public
Reference Room at 100 F Street NE, Washington, D.C. 20549. You can
request copies of such documents by writing to the SEC and paying a
fee for the copying cost. You may obtain information on the
operation of the Public Reference Room by calling the SEC at
1-800-SEC-0330. The SEC maintains a web site at http://www.sec.gov
that contains reports, proxy and information statements and other
information regarding registrants that file electronically with the
SEC.
This prospectus is part of a registration statement on
Form S-3 that we filed with the SEC. Certain information in
the registration statement has been omitted from this prospectus in
accordance with the rules and regulations of the SEC. We have
also filed exhibits and schedules with the registration statement
that are excluded from this prospectus. For further information you
may:
|
· |
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, is not part of this prospectus.
INCORPORATION OF DOCUMENTS
BY REFERENCE
The SEC allows us to “incorporate by reference” information into
this prospectus. This means that we can disclose important
information to you by referring you to another document filed
separately with the SEC. The information incorporated by reference
is considered to be a part of this prospectus, except for any
information that is superseded by other information that is
included in this prospectus.
We incorporate by reference into this prospectus the following
document, which we have previously filed with the SEC:
In addition, all documents subsequently filed by us pursuant to
Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act prior
to the termination of the offering will be deemed to be
incorporated by reference into this prospectus.
You should rely only on the information contained in this
prospectus, as updated and supplemented by any prospectus
supplement, or that information to which this prospectus or any
prospectus supplement has referred you by reference. We have not
authorized anyone to provide you with any additional
information.
Any statement contained in a document incorporated or deemed to be
incorporated by reference herein will be deemed to be modified or
superseded for purposes of this prospectus to the extent that a
statement contained herein modifies or supersedes such statement.
Any statement so modified or superseded will not be deemed, except
as so modified or superseded, to constitute a part of this
prospectus.
You may request and obtain a copy of any of the filings
incorporated herein by reference, at no cost, by writing or
telephoning us at the following address or phone number:
Cellectar Biosciences, Inc.
100 Campus Drive
Florham Park, New Jersey 07932
Attention: Chief Financial Officer (608) 441-8120

CELLECTAR BIOSCIENCES, INC.
$14,500,000
Common Stock
Prospectus
Oppenheimer & Co.
,
2020.
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
We estimate that expenses in connection with the distribution
described in this registration statement (other than brokerage
commissions, discounts or other expenses relating to the sale of
the shares by the selling stockholders) will be as set forth below.
We will pay all of the expenses with respect to the distribution,
and such amounts, with the exception of the Securities and Exchange
Commission registration fee and FINRA fee, are estimates.
Securities and Exchange Commission registration fee |
|
$ |
12,980 |
|
Transfer agent’s and
trustee’s fees and expenses |
|
|
* |
|
Printing and
engraving expenses |
|
|
* |
|
Legal fees and
expenses |
|
|
* |
|
Accounting fees and
expenses |
|
|
* |
|
Miscellaneous
expenses |
|
|
* |
|
Total |
|
$ |
* |
|
Item 15. Indemnification of Directors and Officers
Our charter contains provisions to indemnify our directors and
officers to the maximum extent permitted by Delaware law. We
believe that indemnification under our charter covers at least
negligence on the part of an indemnified person. Our charter
permits us to advance expenses incurred by an indemnified person in
connection with the defense of any action or proceeding arising out
of the person’s status or service as our director, officer,
employee or other agent upon an undertaking by the person to repay
those advances if it is ultimately determined that the person is
not entitled to indemnification.
Insofar as indemnification for liabilities arising under the
Securities Act may be permitted to directors, officers and
controlling persons of the registrant pursuant to the foregoing
provisions, or otherwise, the registrant has been advised that in
the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable.
The
underwriting agreement to be filed as Exhibit 1.1
to this
Registration Statement provides for indemnification by the
underwriter of us and our directors and officers for certain
liabilities under the Securities Act, or otherwise.
Item 16. Exhibits.
(a) Exhibits.
The exhibits to the registration statement are listed in the
Exhibit Index attached hereto and incorporated by reference
herein.
(b) Financial Statement Schedules.
Financial statement schedules have been omitted, as the information
required to be set forth therein is included in the consolidated
financial statements or notes thereto appearing in the prospectus
made part of this registration statement.
EXHIBIT INDEX
|
|
|
|
Incorporated by Reference |
Exhibit
No. |
|
Description |
|
Form |
|
Filing Date |
|
Exhibit
No. |
1.1* |
|
Form of Underwriting Agreement |
|
|
|
|
|
|
2.1 |
|
Agreement and Plan of Merger by and
among Novelos Therapeutics, Inc., Cell Acquisition Corp. and
Cellectar, Inc. dated April 8, 2011 |
|
8-K |
|
April 11, 2011 |
|
2.1 |
3.1 |
|
Second Amended and Restated
Certificate of Incorporation |
|
8-K |
|
April 11, 2011 |
|
3.1 |
3.2 |
|
Certificate of Ownership and Merger
of Cellectar Biosciences, Inc. with and into Novelos
Therapeutics, Inc. |
|
8-K |
|
February 13, 2014 |
|
3.1 |
3.3 |
|
Certificate of Amendment to Second
Amended and Restated Certificate of Incorporation |
|
8-K |
|
June 13, 2014 |
|
3.1 |
3.4 |
|
Certificate of Amendment to Second
Amended and Restated Certificate of Incorporation |
|
8-K |
|
June 19, 2015 |
|
3.2 |
3.5 |
|
Certificate of Amendment to Second
Amended and Restated Certificate of Incorporation |
|
8-K |
|
March 4, 2016 |
|
3.1 |
3.6 |
|
Certificate of Amendment to Second
Amended and Restated Certificate of Incorporation |
|
8-K |
|
June 1, 2017 |
|
3.2 |
3.7 |
|
Certificate of Amendment of Second
Amended and Restated Certificate of Incorporation |
|
8-K |
|
July 13, 2018 |
|
3.1 |
3.8 |
|
Amended and Restated
By-laws |
|
8-K |
|
June 1, 2011 |
|
3.1 |
4.1 |
|
Form of Common Stock
Certificate |
|
S-1/A |
|
November 9, 2011 |
|
4.1 |
4.2* |
|
Form of Preferred Stock Certificate |
|
|
|
|
|
|
4.3* |
|
Form of Certificate of Designation with respect to
Preferred Stock |
|
|
|
|
|
|
4.4* |
|
Form of Warrant Agreement |
|
|
|
|
|
|
4.5* |
|
Form of Unit Agreement |
|
|
|
|
|
|
4.6* |
|
Form of Subscription Rights Agreement |
|
|
|
|
|
|
5.1** |
|
Opinion of Michael Best &
Friedrich LLP |
|
|
|
|
|
|
23.1** |
|
Consent of Independent Registered Public
Accounting Firm |
|
|
|
|
|
|
23.2** |
|
Consent of Michael Best &
Friedrich LLP (included in Exhibit 5.1) |
|
|
|
|
|
|
24.1*** |
|
Power of Attorney (included on signature
page) |
|
|
|
|
|
|
* |
To
be filed as an exhibit to a current report of the registrant on
Form 8-K or other document to be incorporated herein by
reference. |
** |
Filed
herewith. |
*** |
Included on the
signature page to the registration statement. |
Item 17. Undertakings.
The undersigned registrant hereby undertakes to provide to the
underwriter at the closing specified in the underwriting agreement
certificates in such denominations and registered in such names as
required by the underwriter to permit prompt delivery to each
purchaser.
(a) The undersigned registrant hereby undertakes:
1. To file, during any period in which offers or sales are being
made, a post-effective amendment to this registration
statement:
|
(i) |
To include any prospectus required by section 10(a)(3) of
the Securities Act of 1933; |
|
(ii) |
To reflect in the prospectus any facts or events arising after
the effective date of the registration statement (or the most
recent post-effective amendment thereof) which, individually or in
the aggregate, represent a fundamental change in the information
set forth in the registration statement. Notwithstanding the
foregoing, any increase or decrease in volume of securities offered
(if the total dollar value of securities offered would not exceed
that which was registered) and any deviation from the low or high
end of the estimated maximum offering range may be reflected in the
form of prospectus filed with the Commission pursuant to
Rule 424(b) if, in the aggregate, the changes in volume
and price represent no more than 20% change in the maximum
aggregate offering price set forth in the “Calculation of
Registration Fee” table in the effective registration
statement. |
|
(iii) |
To include any material information with respect to the plan of
distribution not previously disclosed in the registration statement
or any material change to such information in the registration
statement; |
provided however, that paragraphs (a)(1)(i), (ii), and
(iii) of this section do not apply if the information required
to be included in a post-effective amendment by those paragraphs is
contained in reports filed with or furnished to the Commission by
the registrant pursuant to Section 13 or
Section 15(d) of the Exchange Act that are incorporated
by reference in the registration statement or contained in a form
of prospectus filed pursuant to § 230.424(b) of the Securities
Act that is part of the registration statement.
2. That, for the purpose of determining any liability under the
Securities Act of 1933, each such post-effective amendment shall be
deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at
that time shall be deemed to be the initial bona fide offering
thereof.
3. To remove from registration by means of a post-effective
amendment any of the securities being registered which remain
unsold at the termination of the offering.
4. That, for the purpose of determining liability under the
Securities Act of 1933 to any purchaser:
(A) Each prospectus filed by the registrant pursuant to
Rule 424(b)(3) shall be deemed to be part of the
registration statement as of the date the filed prospectus was
deemed part of and included in the registration statement; and
(B) Each prospectus required to be filed pursuant to
Rule 424(b)(2), (b)(5), or (b)(7) as part of a
registration statement in reliance on Rule 430B relating to an
offering made pursuant to Rule 415(a)(1)(i), (vii), or
(x) for the purpose of providing the information required by
Section 10(a) of the Securities Act shall be deemed to be
part of and included in the registration statement as of the
earlier of the date such form of prospectus is first used after
effectiveness or the date of the first contract of sale of
securities in the offering described in the prospectus. As provided
in Rule 430B, for liability purposes of the issuer and any
person that is at that date an underwriter, such date shall be
deemed to be a new effective date of the registration statement
relating to the securities in the registration statement to which
that prospectus relates, and the offering of such securities at
that time shall be deemed to be the initial bona fide offering
thereof. Provided, however, that no statement made in a
registration statement or prospectus that is part of the
registration statement or made in a document incorporated or deemed
incorporated by reference into the registration statement or
prospectus that is part of the registration statement will, as to a
purchaser with a time of contract of sale prior to such effective
date, supersede or modify any statement that was made in the
registration statement or prospectus that was part of the
registration statement or made in any such document immediately
prior to such effective date.
5. That, for the purpose of determining liability of the registrant
under the Securities Act of 1933 to any purchaser in the initial
distribution of the securities: The undersigned registrant
undertakes that in a primary offering of securities of the
undersigned registrant pursuant to this registration statement,
regardless of the underwriting method used to sell the securities
to the purchaser, if the securities are offered or sold to such
purchaser by means of any of the following communications, the
undersigned registrant will be a seller to the purchaser and will
be considered to offer or sell such securities to such
purchaser:
|
(i) |
Any preliminary prospectus or prospectus of the undersigned
registrant relating to the offering required to be filed pursuant
to Rule 424; |
|
(ii) |
Any free writing prospectus relating to the offering prepared
by or on behalf of the undersigned registrant or used or referred
to by the undersigned registrant; |
|
(iii) |
The portion of any other free writing prospectus relating to
the offering containing material information about the undersigned
registrant or its securities provided by or on behalf of the
undersigned registrant; and |
|
(iv) |
Any other communication that is an offer in the offering made
by the undersigned registrant to the purchaser. |
(b) The undersigned registrant hereby undertakes that, for
purposes of determining any liability under the Securities Act of
1933, each filing of the registrant's annual report pursuant to
section 13(a) or section 15(d) of the Securities Exchange
Act of 1934 (and, where applicable, each filing of an employee
benefit plan's annual report pursuant to section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference
in the registration statement shall be deemed to be a new
registration statement relating to the securities offered therein,
and the offering of such securities at that time shall be deemed to
be the initial bona fide offering thereof.
(c) Insofar as indemnification for liabilities arising under
the Securities Act of 1933 may be permitted to directors, officers
and controlling persons of the registrant pursuant to the foregoing
provisions, or otherwise, the registrant has been advised that in
the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the Act
and is, therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by
the registrant of expenses incurred or paid by a director, officer
or controlling person of the registrant in the successful defense
of any action, suit or proceeding) is asserted by such director,
officer or controlling person in connection with the securities
being registered, the registrant will, unless in the opinion of its
counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in
the Act and will be governed by the final adjudication of such
issue.
The undersigned registrant hereby undertakes that:
(1) For purposes of determining any
liability under the Securities Act of 1933, the information omitted
from the form of prospectus filed as part of this registration
statement in reliance upon Rule 430A and contained in a form
of prospectus filed by the registrant pursuant to
Rule 424(b)(1) or (4) or 497(h) under the
Securities Act of 1933 shall be deemed to be part of this
registration statement as of the time it was declared
effective.
(2) For the purpose of determining any
liability under the Securities Act of 1933, each post-effective
amendment that contains a form of prospectus shall be deemed to be
a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be
deemed to be the initial bona fide offering thereof.
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the
registrant certifies that it has reasonable grounds to believe that
it meets all of the requirements for filing on Form S-3 and
has duly caused this registration statement to be signed on its
behalf by the undersigned, thereunto duly authorized, in the City
of Florham Park, State of New Jersey, on August 11, 2020.
|
CELLECTAR BIOSCIENCES, INC. |
|
|
|
By: |
/s/ James V.
Caruso |
|
|
James V. Caruso |
|
|
President and Chief Executive Officer |
POWER OF ATTORNEY
We, the undersigned officers and directors of Cellectar
Biosciences, Inc., hereby severally constitute and appoint
James V. Caruso and Dov Elefant, and each of them singly (with full
power to each of them to act alone), our true and lawful
attorneys-in-fact and agents, with full power of substitution and
resubstitution in each of them for him and in his name, place and
stead, and in any and all capacities, to sign for us and in our
names in the capacities indicated below any and all amendments
(including post-effective amendments) to this registration
statement (or any other registration statement for the same
offering that is to be effective upon filing pursuant to
Rule 462(b) under the Securities Act of 1933, as
amended), and to file the same, with all exhibits thereto and other
documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents, and
each of them, full power and authority to do and perform each and
every act and thing requisite or necessary to be done in and about
the premises, as full to all intents and purposes as he might or
could do in person, hereby ratifying and confirming all that said
attorneys-in-fact and agents or any of them, or their or his
substitute or substitutes, may lawfully do or cause to be done by
virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this
registration statement has been signed by the following persons in
the capacities and on the dates indicated.
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/James V. Caruso |
|
Chief Executive Officer and
Director |
|
August 11, 2020 |
James V. Caruso |
|
(principal executive
officer) |
|
|
|
|
|
|
|
/s/
Dov Elefant |
|
Chief Financial Officer |
|
August 11,
2020 |
Dov Elefant |
|
(principal financial officer and
principal accounting officer) |
|
|
|
|
|
|
|
/s/
Frederick W. Driscoll |
|
Director |
|
August 11,
2020 |
Frederick W. Driscoll |
|
|
|
|
|
|
|
|
|
/s/
Stephen A. Hill |
|
Director |
|
August 11,
2020 |
Stephen A. Hill |
|
|
|
|
|
|
|
|
|
/s/
Stefan D. Loren, Ph.D. |
|
Director |
|
August 11,
2020 |
Stefan D. Loren, Ph.D. |
|
|
|
|
|
|
|
|
|
/s/
John Neis |
|
Director |
|
August 11,
2020 |
John Neis |
|
|
|
|
|
|
|
|
|
/s/
Douglas J. Swirsky |
|
Director |
|
August 11,
2020 |
Douglas J. Swirsky |
|
|
|
|