As filed with the Securities and Exchange Commission on January 21,
2021
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(2) |
Proposed
Maximum
Aggregate
Offering
Price(2) |
Amount of
Registration
Fee(2) |
Common Stock, par value $0.00001 per
share(2) |
15,185,180 |
$1.975 |
$29,990,731 |
$3,272 |
|
(1) |
Consists of shares of Common Stock
issuable upon conversion of shares of Series D Preferred
Stock, to be offered and sold by the Selling Stockholders
identified in this registration statement. This registration
statement also relates to an indeterminate number of shares of
common stock that may be issued upon stock splits, stock dividends
or similar transactions in accordance with Rule 416 under the
Securities Act of 1933, as amended (the “Securities Act”).. |
|
(2) |
Estimated solely for the purpose of
calculating the registration fee for the shares of Common Stock
registered hereunder issuable upon the conversion of shares of
Series D Preferred Stock to be registered in accordance with
Rule 457(c) under the Securities Act, based upon the
average of the high and low prices for a share of the registrant’s
common stock as reported on the Nasdaq Capital Market on
January 20, 2021, which date is a date within five business
days of the filing of this registration statement. |
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 JANUARY 21, 2021

CELLECTAR BIOSCIENCES, INC.
15,185,180 Shares of Common Stock Issuable upon Conversion of
Series D Preferred Stock
Cellectar Biosciences, Inc. (“we,” “us” or the “Company”) are
not selling any shares of our common stock under this prospectus
and will not receive any proceeds from the sale of shares by the
selling stockholders identified herein (the “Selling
Stockholders”). This prospectus relates to the resale of up to
15,185,180 shares of our Common Stock issuable upon conversion of
1,518.5180 shares of our Series D Preferred Stock (the
“Series D Preferred Shares”). The Series D Preferred
Shares are convertible into a number of shares of common stock
equal to $13,500 divided by $1.35 (or 10,000 shares of common stock
for each share of Series D Preferred Stock converted). The
Series D Preferred Shares will only be convertible into common
stock upon receipt of stockholder approval of the issuance of the
underlying shares of common stock (“Stockholder Approval”) as
required by Nasdaq Marketplace Rule 5635(d) at a special
stockholder meeting to be held on February 25, 2021 (the
“Special Meeting”). If our stockholders do not approve the
Stockholder Proposal, then the Series D Preferred Shares will
not be convertible into shares of Common Stock and we will be
required to seek stockholder approval every three months following
the date of the Special Meeting.
The Selling Stockholders will bear all commissions and discounts,
if any, attributable to the sale of the shares. We will bear all
costs, expenses and fees in connection with the registration of the
shares.
The Selling Stockholders may sell the shares of our Common Stock
offered by this prospectus from time to time on terms to be
determined at the time of sale through ordinary brokerage
transactions or through any other means described in this
prospectus under “Plan of Distribution.” The prices at which the
Selling Stockholder may sell the shares will be determined by the
prevailing market price for the shares or in negotiated
transactions.
Our common stock is listed on the Nasdaq Capital Market under the
symbol “CLRB”. On January 20, 2021, the last reported sale
price of our common stock on the Nasdaq Capital Market was $1.94
per share.
Investing in our securities involves a high degree of risk. See
“Risk Factors” beginning on page 13 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 , 2021.
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
You should rely only on the information we have provided or
incorporated by reference into this prospectus and any related free
writing prospectus. We have not authorized anyone to provide you
with information different from that contained in this prospectus
or any related free writing prospectus. No dealer, salesperson or
other person is authorized to give any information or to represent
anything not contained in this prospectus or any related free
writing prospectus. You must not rely on any unauthorized
information or representation. This prospectus is an offer to sell
only the common stock offered hereby, but only under circumstances
and in jurisdictions where it is lawful to do so. You should assume
that the information in this prospectus or any related free writing
prospectus is accurate only as of the date on the front of the
document and that any information we have incorporated by reference
is accurate only as of the date of the document incorporated by
reference, regardless of the time of delivery of this prospectus or
any sale of a security.
We may authorize one or more free writing prospectuses to be
provided to you that may contain material information relating to
that offering. We may also use any related free writing prospectus
to add, update or change any of the information contained in this
prospectus or in documents we have incorporated by reference. This
prospectus, together with any related free writing prospectuses and
the documents incorporated by reference into this prospectus,
includes all material information relating to this offering. Please
carefully read both this prospectus together with the additional
information described below under “Incorporation of Documents by
Reference”.
Unless otherwise stated or unless the context otherwise requires,
all references to “we”, “us”, “our”, “our company” or “the Company”
in this prospectus refer collectively to Cellectar
Biosciences, Inc., a Delaware corporation.
CAUTIONARY NOTE REGARDING
FORWARD-LOOKING STATEMENTS
This prospectus, including the documents that we incorporate by
reference, contains forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933, as amended (the
“Securities Act”), and Section 21E of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”). Examples of our
forward-looking statements include:
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our current views with
respect to our business strategy, business plan and research and
development activities; |
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the future impacts of
the COVID-19 pandemic on our business, employees, operating
results, ability to obtain additional funding, product development
programs, research and development programs, suppliers and
third-party manufacturers; |
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the progress of our
product development programs, including clinical testing and the
timing of commencement and results thereof; |
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our projected
operating results, including research and development
expenses; |
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our ability to
continue development plans for CLR 131, CLR 1900 series, CLR 2000
series and CLR 12120; |
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our ability to
continue development plans for our Phospholipid Drug Conjugates
(PDC)™; |
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our ability to maintain orphan drug
designation in the U.S. for CLR 131 as a therapeutic for the
treatment of multiple myeloma, neuroblastoma, osteosarcoma,
rhabdomyosarcoma, Ewing’s sarcoma and lymphoplasmacytic lymphoma,
and the expected benefits of orphan drug status; |
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any disruptions at our sole supplier of CLR
131; |
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our ability to pursue strategic
alternatives; |
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our ability to advance our technologies into
product candidates; |
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our enhancement and consumption of current
resources along with ability to obtain additional funding; |
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our current view regarding general economic
and market conditions, including our competitive strengths; |
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· |
uncertainty and economic instability
resulting from conflicts, military actions, terrorist attacks,
natural disasters, public health crises, including the occurrence
of a contagious disease or illness, including the COVID-19
pandemic, cyber-attacks and general instability; |
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· |
assumptions underlying any of the foregoing;
and |
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· |
any other statements that address events or
developments that we intend or believe will or may occur in the
future. |
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 late-stage clinical biopharmaceutical company focused on
the discovery, development and commercialization of drugs for the
treatment of cancer. Our core objective is to leverage our
proprietary phospholipid drug conjugate™ (PDC™) delivery
platform to develop PDCs that are designed to specifically target
cancer cells and deliver improved efficacy and better safety as a
result of fewer off-target effects. Our PDC platform possesses
the potential for the discovery and development of the next
generation of cancer-targeting treatments, and we plan to develop
PDCs both independently and through research and development
collaborations.
The COVID-19 pandemic has created uncertainties in the expected
timelines for clinical stage biopharmaceutical companies such as
us, and because of such uncertainties, it is difficult for us to
accurately predict expected outcomes. We have not yet experienced
any significant impacts as a result of the pandemic. However,
COVID-19 may impact our future ability to recruit patients for
clinical studies, obtain adequate supply of CLR 131 and obtain
additional financing.
Our lead PDC therapeutic, CLR 131 is a small-molecule PDC designed
to provide targeted delivery of iodine-131 directly to cancer
cells, while limiting exposure to healthy cells. We believe this
profile differentiates CLR 131 from many traditional on-market
treatments. CLR 131 is currently being evaluated in the multi cohort
CLOVER 1 Phase 2 study in adult B-cell malignancies and the
CLOVER-2 Phase 1 study for a variety of pediatric
cancers.
The CLOVER-1 Phase 2 study met the primary efficacy endpoints from
the Part A dose-finding portion, conducted in relapsed/refractory
(r/r) B-cell malignancies. The CLOVER-1 Phase 2 Part B expansion
cohort is a pivotal registration study currently evaluating CLR 131
in Bruton tyrosine kinase (BTK) inhibitor failed or suboptimal
response Waldenstrom’s macroglobulinemia (WM). The CLOVER-1 Phase 2
Part A study is ongoing and CLR 131 remains under further
evaluation in highly refractory multiple myeloma (MM) patients in
an expansion cohort.
The CLOVER-2 Phase 1 pediatric study is an open-label,
sequential-group, dose-escalation study to evaluate the safety and
tolerability of CLR 131 in children and adolescents with relapsed
or refractory cancers, including malignant brain tumors,
neuroblastoma, sarcomas, and lymphomas (including Hodgkin’s
lymphoma). The study is being conducted internationally at seven
leading pediatric cancer centers.
The U.S. Food and Drug Administration (“FDA”) granted CLR 131 Fast
Track Designation for WM patients having received two or more prior
treatment regimens, as well as r/r MM and r/r diffuse large B-cell
lymphoma (DLBCL). Orphan Drug Designations (ODD’s) have been
granted for WM, MM, 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. 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 three ongoing
collaborations featuring four unique payloads and mechanisms of
action. Through research and development collaborations, our
strategy is to generate near-term capital, supplement internal
resources, gain access to novel molecules or payloads, accelerate
product candidate development and broaden our proprietary and
partnered product pipelines.
Our PDC platform provides selective delivery of a diverse range of
oncologic payloads to cancerous cells, whether a hematologic cancer
or solid tumor, a primary tumor, or a metastatic tumor and cancer
stem cells. The PDC platform’s mechanism of entry does not rely
upon specific cell surface epitopes or antigens as are required by
other targeted delivery platforms. Our PDC platform takes advantage
of a metabolic pathway utilized by all tumor cell types in all
stages of the tumor cycle. Tumor cells modify specific regions on
the cell surface as a result of the utilization of this metabolic
pathway. Our PDCs bind to these regions and directly enter the
intracellular compartment. This mechanism allows the PDC molecules
to accumulate over time, which enhances drug efficacy, and to avoid
the specialized highly acidic cellular compartment known as
lysosomes, which allows a PDC to deliver molecules that previously
could not be delivered. Additionally, molecules targeting specific
cell surface epitopes face challenges in completely eliminating a
tumor because the targeted antigens are limited in the total number
on the cell surface, have longer cycling time from internalization
to being present on the cell surface again and available for
binding and are not present on all of the tumor cells in any
cancer. This means a subpopulation of tumor cells always exist that
cannot be targeted by therapies targeting specific surface
epitopes. In addition to the benefits provided by the mechanism of
entry, PDCs offer the ability to conjugate payload molecules in
numerous ways, thereby increasing the types of molecules
selectively delivered via the PDC.
The PDC platform features include the capacity to link with almost
any molecule, provide a significant increase in targeted oncologic
payload delivery and the ability to target all types of tumor
cells. As a result, we believe that we can generate PDCs to treat a
broad range of cancers with the potential to improve the
therapeutic index of oncologic drug payloads, enhance or maintain
efficacy while also reducing adverse events by minimizing drug
delivery to healthy cells, and increasing delivery to cancerous
cells and cancer stem cells.
We employ a drug discovery and development approach that allows us
to efficiently design, research and advance drug candidates. Our
iterative process allows us to rapidly and systematically produce
multiple generations of incrementally improved targeted drug
candidates.
In June 2020, the European Medicines Agency (EMA) granted us
Small and Medium-Sized Enterprise status by the EMA’s Micro, Small
and Medium-sized Enterprise office. SME status allows us to
participate in significant financial incentives that include a 90%
to 100% EMA fee reduction for scientific advice, clinical study
protocol design, endpoints and statistical considerations, quality
inspections of facilities and fee waivers for selective EMA pre and
post-authorization regulatory filings, including orphan drug and
PRIME designations. We are also eligible to obtain EMA
certification of quality and manufacturing data prior to review of
clinical data. Other financial incentives include EMA-provided
translational services of all regulatory documents required for
market authorization, further reducing the financial burden of the
market authorization process.
A description of our PDC product candidates follows:
Clinical Pipeline
Our lead PDC therapeutic, CLR 131 is a small-molecule, PDC designed
to provide targeted delivery of iodine-131 directly to cancer
cells, while limiting exposure to healthy cells. We believe this
profile differentiates CLR 131 from many traditional on-market
treatments and treatments in development. CLR 131 is currently
being evaluated in two clinical studies: the multi-cohort CLOVER-1
Phase 2 adult B-cell malignancy study and the CLOVER-2 Phase 1
pediatric safety study.
The CLOVER-1 Phase 2 study met the primary efficacy endpoints from
the Part A dose-finding portion, conducted in r/r B-cell
malignancies, and is now enrolling in two expansion cohorts. The
first is expansion cohort is the Pivotal study in Waldenstrom’s
macroglobulinemia patients that have received first line standard
of care and failed BTK inhibitor treatment. The second expansion
cohort will evaluate quad class refractory MM. The dosing regimen
in both cohorts is designed to provide the optimal dose of
>60mCi total body dose (TBD) identified in Part A.
The initial Investigational New Drug (IND) application was accepted
by the FDA in March 2014 with multiple INDs submitted since
that time. Initiated in March 2017, the primary goal of the
Phase 2A study was to assess the compound’s efficacy in a broad
range of hematologic cancers. In the expansion portion of the study
the goal is to confirm the efficacy of the >60mCi TBD in
triple class refractory MM and BTK inhibitor failed WM patients.
The Phase 1 study was designed to assess the compound’s safety and
tolerability in patients with r/r MM (to determine maximum
tolerated dose (MTD)) and was initiated in April 2015. The
study completed enrollment and the final clinical study report is
expected in the first half of 2021.
The CLOVER-2 Phase 1 pediatric study is being conducted
internationally at seven leading pediatric cancer centers. The
study is an open-label, sequential-group, dose-escalation study to
evaluate the safety and tolerability of CLR 131 in children and
adolescents with relapsed or refractory cancers, including
malignant brain tumors, neuroblastoma, sarcomas, and lymphomas
(including Hodgkin’s lymphoma). The FDA previously accepted our IND
application for a Phase 1 open-label, dose escalating study to
evaluate the safety and tolerability of a single intravenous
administration of CLR 131 in up to 30 children and adolescents with
cancers including neuroblastoma, sarcomas, lymphomas (including
Hodgkin’s lymphoma) and malignant brain tumors. This study was
initiated during the first quarter of 2019. These cancer types were
selected for clinical, regulatory and commercial rationales,
including the radiosensitive nature and continued unmet medical
need in the r/r setting, and the rare disease determinations made
by the FDA based upon the current definition within the Orphan Drug
Act.
In December 2014, the FDA granted ODD for CLR 131 for the
treatment of MM. In 2018, the FDA granted ODD and RPDD for CLR 131
for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s
sarcoma and osteosarcoma. In May 2019, the FDA granted Fast
Track designation for CLR 131 for the treatment of MM and in
July 2019 for the treatment of DLBCL, in September 2019
CLR 131 received Orphan Drug Designation from the European Union
for Multiple Myeloma, and in January 2020, the FDA granted
Orphan Drug Designation for CLR 131 Waldenstrom’s
macroglobulinemia. The FDA granted Fast Track designation for CLR
131 for the treatment of WM in May 2020.
The FDA may award priority review vouchers to sponsors of a RPDD
that meet its specified criteria. The key criteria to receiving a
priority review voucher (PRV) is that the disease being treated is
life-threatening and that it primarily effects individuals under
the age of 18. Under this program, a sponsor who receives an
approval for a drug or biologic for a rare pediatric disease can
receive a PRV that can be redeemed to receive a priority review of
a subsequent marketing application for a different product.
Additionally, the PRV’s can be exchanged or sold to other companies
so that the receiving company may use the voucher.
Phase 2 Study Pivotal Cohort: Patients with r/r Waldenstrom’s
Macroglobulinemia
In January 2021, we
announced that a Type C guidance meeting with the FDA was conducted
in September of 2020. The results of that guidance meeting
provided Cellectar with an agreed upon path for conducting a single
arm, pivotal Phase 2 expansion cohort in Waldenstrom’s
macroglobulinemia patients that have received standard of care
first line therapy and had a suboptimal response or failed BTKi
therapy. The FDA agreed with the dose to be tested, our proposal
for a safety and futility assessment to be conduct on the first 10
patients, the endpoint to be assessed, the statistical analysis
plan and study size of 50 patients. Based upon this agreement the
pivotal study was initiated.
Phase 2 Study Cohort A: Patients with r/r Waldenstrom’s
Macroglobulinemia
Current data from our Phase 2 CLOVER-1 clinical study show that six
WM patients demonstrated 100% overall response rate (ORR) and an
83.3% major response rate with one patient achieving a CR which
continues at nearly 27 months post- last treatment. All patients
met the definition of having received first line standard of care
and failed treatment with BTK inhibitors. While median treatment
free survival and duration of response has not been reached, the
average treatment free survival is currently at 330 days. This may
represent an important improvement in the treatment of
relapsed/refractory WM as we believe no approved or late-stage
development treatments for second- and third-line patients have
reported a CR. WM is a rare, indolent and incurable form of
non-Hodgkin’s lymphoma (NHL) that is composed of a patient
population in need of new and better treatment options.
Phase 2 Study Cohort B: Patients with r/r Multiple
Myeloma
In September 2020, we announced that a clinically meaningful
40% ORR was observed in the subset of refractory multiple myeloma
patients deemed triple class refractory who received 60 mCi or
greater TBD. Triple class refractory is defined as patients that
are refractory to immunomodulatory, proteasome inhibitors and
anti-CD38 antibody drug classes. The 40% ORR (6/15 patients)
represents triple class refractory patients enrolled in Part A
of Cellectar’s CLOVER-1 study and additional patients enrolled in
Part B from March through May 2020 and received
>60mCi TBD. All MM patients enrolled in the expansion
cohort are required to be triple class refractory. The additional
six patients were heavily pre-treated with an average of nine prior
multi-drug regimens. Three patients received a total body dose of
> 60 mCi and three received less than 60 mCi. Consistent
with the data released in February 2020, patients receiving
> 60 mCi typically exhibit greater responses. Based on
study results to date, patients continue to tolerate CLR 131 well,
with the most common and almost exclusive treatment emergent
adverse events being cytopenias. This cohort will continue to enroll and
evaluate patients that are even more refractory (quad-class
refractory (proteasome inhibitor, immunomodulatory drug, anti-CD-38
antibodies, nuclear export inhibitors, or BCMA antibody drug
conjugates) or hepta-drug refractory) to determine if CLR 131 at
the dose of >60mCi TBD can be effective in patients that
likely have no alternative therapies.
Previously in
February 2020, we had announced that patients in the r/r
multiple myeloma cohort received one of three different doses of
CLR 131 (<50mCi, ~50mCi and >60mCi total body dose
(TBD)). CLR 131 achieved the primary endpoint for the study.
Patients with r/r MM who received the >60mCi TBD of CLR
131 showed a 42.8% overall response rate (ORR). Those who received
~50mCi TBD had a 26.3% ORR with a combined rate of 34.5% ORR (n=33)
while maintaining a well-tolerated safety profile. Patients in the
studies were elderly with a median age of 70, and heavily
pre-treated, with a median of five prior lines of treatment (range:
3 to 17), which included immunomodulatory drugs, proteasome
inhibitors and CD38 antibodies for the majority of patients.
Additionally, a majority of the patients (53%) were quad refractory
or greater and 44% of all treated multiple myeloma patients were
triple class refractory. 100% of all evaluable patients (n=43)
achieved clinical benefit (primary outcome measure) as defined by
having stable disease or better. 85.7% of multiple myeloma patients
receiving the higher total body dose levels of CLR 131 experienced
tumor reduction. The >60mCi TBD demonstrated positive
activity in both high-risk patients and triple class refractory
patients with a 50% and 33% ORR, respectively.
Phase 2 Study Cohort C: Patients with r/r non-Hodgkin’s
lymphoma
In February 2020, we
announced positive data from our Phase 2 CLOVER-1 study in patients
with relapsed/refractory non-Hodgkin lymphoma (NHL) patients
were treated with three different doses (<50mCi, ~50mCi and
>60mCi total body dose (TBD). The <50mCi total body
dose was a deliberately planned sub-therapeutic dose. Patients with
r/r NHL who received <60mCi TBD and the >60mCi TBD had
a 42% and 43% ORR, respectively and a combined rate of 42%. These
patients were also heavily pre-treated, having a median of three
prior lines of treatment (range, 1 to 9) with the majority
of patients being refractory to rituximab and/or ibrutinib. The
patients had a median age of 70 with a range of 51 to 86. All
patients had bone marrow involvement with an average of 23%. In
addition to these findings, subtype assessments were completed in
the r/r B-cell NHL patients. Patients with DLBCL demonstrated a 30%
ORR with one patient achieving a complete response (CR), which
continues at nearly 24 months post-treatment. The ORR for
CLL/SLL/MZL patients was 33%.
Based upon the dose response observed in Part A patients
receiving total body doses of 60mCi or greater, we determined that
patient dosing of CLR 131 would be >60mCi TBD. Therefore,
patients are now grouped as receiving <60mCi or >60mCi
TBD.
The most frequently reported
adverse events in all patients were cytopenias, which followed a
predictable course and timeline. The frequency of adverse events
have not increased as doses were increased and the profile of
cytopenias remains consistent. Importantly, these cytopenias have
had a predictable pattern to initiation, nadir and recovery and are
treatable. The most common grade ≥3 events at the highest dose
(75mCi TBD) were hematologic toxicities including thrombocytopenia
(65%), neutropenia (41%), leukopenia (30%), anemia (24%) and
lymphopenia (35%). No patients experienced cardiotoxicities,
neurological toxicities, infusion site reactions, peripheral
neuropathy, allergic reactions, cytokine release syndrome,
keratopathy, renal toxicities, or changes in liver enzymes. The
safety and tolerability profile in patients with r/r NHL was
similar to r/r MM patients except for fewer cytopenias of any
grade. Based upon CLR 131 being well tolerated across all dose
groups and the observed response rate, especially in difficult to
treat patients such as high risk and triple class refractory or
penta-refractory, and corroborating data showing the potential to
further improve upon current ORRs and durability of those
responses, the study has been expanded to test a two-cycle dosing
optimization regimen with a target total body dose >60
mCi/m2 of CLR 131.
In July 2016, we were awarded a $2,000,000 National Cancer
Institute (NCI) Fast-Track Small Business Innovation Research grant
to further advance the clinical development of CLR 131. The funds
are supporting the Phase 2 study initiated in March 2017 to
define the clinical benefits of CLR 131 in r/r MM and other niche
hematologic malignancies with unmet clinical need. These niche
hematologic malignancies include Chronic Lymphocytic Leukemia,
Small Lymphocytic Lymphoma, Marginal Zone Lymphoma,
Lymphoplasmacytic Lymphoma/WM and DLBCL. The study is being
conducted in approximately 10 U.S. cancer centers in patients with
orphan-designated relapse or refractory hematologic cancers. The
study’s primary endpoint is clinical benefit response (CBR), with
secondary endpoints of ORR, progression free survival (PFS,) median
Overall Survival (mOS) and other markers of efficacy following
patients receiving one of three TBDs of CLR 131 (<50mCi, ~50mCi
and >60mCi), with the option for a second cycle
approximately 75-180 days later. Dosages were provided either as
single bolus or fractionated (the assigned dose level split into
two doses) given day 1 and day 15.
In May 2020, we announced that the FDA granted Fast Track
Designation for CLR 131 in WM in patients having received two prior
treatment regimens or more.
Phase 1 Study in Patients with r/r Multiple Myeloma
In February 2020, we announced the successful completion of
our Phase 1 dose escalation study. Data from the study demonstrated
that CLR 131 was safe and tolerated at total body dose of
approximately 95mCi 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 in an up to 30-minute I.V.
infusion, either as a single bolus dose or as fractionated doses.
The r/r multiple myeloma patients in this study received single
cycle doses ranging from approximately 20mCi to 95mCi total body
dose. An independent Data Monitoring Committee determined that all
doses have been safe and well-tolerated by patients.
CLR 131 in combination with dexamethasone was under
investigation in adult patients with r/r MM. Patients had to be
refractory to or relapsed from at least one proteasome inhibitor
and at least one immunomodulatory agent. The clinical study was 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 included the evaluation
of therapeutic activity by assessing surrogate efficacy markers,
which include M protein, free light chain (FLC), PFS and OS. All
patients were 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 or a
total body dose of ~63 mCi. The four single dose cohorts examined
were: 12.5 mCi/m2 (~25mCi TBD), 18.75 mCi/m2
(~37.5mCi TBD), 25 mCi/m2(~50mCi TBD), and 31.25
mCi/m2(~62.5mCi TBD), all in combination with low dose
dexamethasone (40 mg weekly). Of the five patients in the first
cohort, four achieved stable disease and one patient progressed at
Day 15 after administration and was taken off the study. Of the
five patients admitted to the second cohort, all five achieved
stable disease however one patient progressed at Day 41 after
administration and was taken off the study. Four patients were
enrolled to the third cohort and all achieved stable disease. In
September 2017, we announced results for cohort 4, showing
that a single infusion up to 30-minutes of 31.25mCi/m2
of CLR 131 was safe and tolerated by the three patients in the
cohort. Additionally, all three patients experienced CBR with one
patient achieving a partial response (PR). We use the International
Myeloma Working Group (IMWG) definitions of response, which involve
monitoring the surrogate markers of efficacy, M protein and FLC.
The IMWG defines a PR as a greater than or equal to 50% decrease in
FLC levels (for patients in whom M protein is unmeasurable) or 50%
or greater decrease in M protein. The patient experiencing a PR had
an 82% reduction in FLC. This patient did not produce M protein,
had received seven prior lines of treatment including radiation,
stem cell transplantation and multiple triple combination
treatments including one with daratumumab that was not tolerated.
One patient experiencing stable disease attained a 44% reduction in
M protein. In January 2019, we announced that the pooled mOS
data from the first four cohorts was 22.0 months. In late 2018, we
modified this study to evaluate a fractionated dosing strategy to
potentially increase efficacy and decrease adverse events.
Cohort 5 and 6 were fractionated cohorts of 31.25
mCi/m2(~62.5mCi TBD) and 37.5 mCi/m2(~75mCi
TBD), each administered on day 1 and on day 8. Following the
determination that all prior dosing cohorts were safe and
tolerated, we initiated a cohort 7 utilizing a 40mCi/m2 (~95mCi
TBD) fractionated dose administered 20mCi/m2 (~40mCi TBD) on days 1
and day 8. Cohort 7 was the highest pre-planned dose cohort and
subjects have completed the evaluation period. The study completed
enrollment and the final clinical study report is expected in the
first half of 2021.
In May 2019, we announced that the FDA granted Fast Track
Designation for CLR 131 in fourth line or later r/r MM. CLR 131 is
our small molecule radiotherapeutic PDC designed to deliver
cytotoxic radiation directly and selectively to cancer cells and
cancer stem cells. It is currently being evaluated in our ongoing
CLOVER-1 Phase 2 clinical study in patients with relapsed or
refractory multiple myeloma and other select B-cell lymphomas.
Phase 1 Study in r/r
Pediatric Patients with select Solid tumors, Lymphomas and
Malignant Brain Tumors
In December 2017 the Division of Oncology at the FDA accepted
our IND and study design for the Phase 1 study of CLR 131 in
children and adolescents with select rare and orphan designated
cancers. This study was initiated during the first quarter of 2019.
In December 2017, we filed an IND application for r/r
pediatric patients with select solid tumors, lymphomas and
malignant brain tumors. The Phase 1 clinical study of CLR 131 is an
open-label, sequential-group, dose-escalation study evaluating the
safety and tolerability of intravenous administration of CLR 131 in
children and adolescents with cancers including neuroblastoma,
sarcomas, lymphomas (including Hodgkin’s lymphoma) and malignant
brain tumors. Secondary objectives of the study are to identify the
recommended efficacious dose of CLR 131 and to determine
preliminary antitumor activity (treatment response) of CLR 131 in
children and adolescents. In August 2020, it was announced
that four dose levels 15mCi/m2 up to 60mCi/m2
were deemed safe and tolerable by an independent Data Monitoring
Committee and evaluation of the next higher dose cohort,
75mCi/m2 was initiated. In 2018, the FDA granted ODD and
RPDD for CLR 131 for the treatment of neuroblastoma,
rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Should any of
these indications be a first approval for CLR 131, the RPDD would
enable us to receive a priority review voucher. Priority review
vouchers can be used by the sponsor to receive priority review for
a future New Drug Application (“NDA”) or Biologic License
Application (“BLA”) submission, which would reduce the FDA review
time from 12 months to six months. Currently, these vouchers can
also be transferred or sold to another entity. This Priority Review
Voucher Program is currently under evaluation for renewal.
Phase 1 Study in r/r Head and Neck Cancer
In August 2016, the University of Wisconsin Carbone Cancer
Center (“UWCCC”) was awarded a five-year Specialized Programs of
Research Excellence (“SPORE”) grant of $12,000,000 from the
National Cancer Institute and the National Institute of Dental and
Craniofacial Research to improve treatments and outcomes for head
and neck cancer, HNC, patients. HNC is the sixth most common cancer
across the world with approximately 56,000 new patients diagnosed
every year in the U.S. As a key component of this grant, the UWCCC
researchers completed testing of CLR 131 in various animal HNC
models and initiated the first human clinical study enrolling up to
30 patients combining CLR 131 and external beam radiation with
recurrent HNC in Q4 2019. This clinical study was suspended due to
the COVID-19 pandemic over the first three quarters of 2020, but is
now open and actively enrolling patients.
Preclinical Pipeline
We believe our PDC platform has potential to provide targeted
delivery of a diverse range of oncologic payloads, as exemplified
by the product candidates listed below, that may result in
improvements upon current standard of care (“SOC”) for the
treatment of a broad range of human cancers:
|
· |
CLR 1900 Series is an internally developed proprietary PDC
program leveraging a novel small molecule cytotoxic compound as the
payload. The payload inhibits mitosis (cell division) and targets a
key pathway required to inhibit rapidly dividing cells that results
in apoptosis. We believe that this program could produce a product
candidate targeted to select solid tumors. Currently, the program
is in early preclinical development and if we elect to progress any
molecules further, we will select preferred candidates. |
|
· |
CLR 2000 Series is a collaborative PDC program with
Avicenna Oncology, or Avicenna, that we entered into in
July 2017. Avicenna is a developer of antibody drug conjugates
(“ADCs”). The objective of the research collaboration is to design
and develop a series of PDCs utilizing Avicenna’s proprietary
cytotoxic payload. Although Avicenna is a developer of ADCs, this
collaboration was sought as a means to overcome many of the
challenges associated with ADCs, including those associated with
the targeting of specific cell surface epitopes. The CLR 2000
Series has demonstrated improved safety, efficacy and tissue
distribution with the cytotoxic payload in animal models. A
candidate molecule and a back-up have been selected for further
advancement at a future time. |
|
· |
CLR 12120 Series is a collaborative PDC program with Orano
Med for the development of novel PDCs utilizing Orano Med’s unique
alpha emitter, lead 212 conjugated to our phospholipid ether; the
companies intend to evaluate the new PDCs in up to three oncology
indications. Currently this series has shown efficacy in the first
two animal models tested. |
Key Risks and Uncertainties
We are subject to numerous risks and uncertainties, including the
following:
|
· |
Our operations and financial condition may be adversely
impacted by the COVID-19 pandemic. |
|
· |
We will require additional capital in order to continue our
operations and may have difficulty raising additional capital. |
|
· |
We are a clinical-stage company with a going concern
qualification to our financial statements and a history of losses,
and we can provide no assurance as to our future operating
results. |
|
· |
We rely on a collaborative outsourced business model, and
disruptions with these third-party collaborators may impede our
ability to gain FDA approval and delay or impair commercialization
of any products. |
|
· |
We will require additional capital in order to continue our
operations and may have difficulty raising additional capital. |
|
· |
We rely on a small number of key personnel who may terminate
their employment with us at any time, and our success will depend
on our ability to hire additional qualified personnel. |
|
· |
We cannot assure the successful development and
commercialization of our compounds in development. |
|
· |
Our proposed products and their potential applications are in
an early stage of clinical and manufacturing/process development
and face a variety of risks and uncertainties. |
|
· |
Failure to complete the development of our technologies, to
obtain government approvals, including required FDA approvals, or
comply with ongoing governmental regulations could prevent, delay
or limit introduction or sale of proposed products and result in
failure to achieve revenues or maintain our ongoing business. |
|
· |
Clinical studies involve a lengthy and expensive process with
an uncertain outcome, and results of earlier studies and trials may
not be predictive of future trial results. |
|
· |
We may be required to suspend or discontinue clinical studies
due to unexpected side effects or other safety risks that could
preclude approval of our product candidates. |
|
· |
Controls we or our third-party collaborators have in place to
ensure compliance with all applicable laws and regulations may not
be effective. |
|
· |
We expect to rely on our patents as well as specialized
regulatory designations such as orphan drug classification for our
product candidates, but regulatory drug designations may not confer
marketing exclusivity or other expected commercial benefits. |
|
· |
The FDA has granted rare pediatric disease designation, RPDD,
to CLR 131 for treatment of neuroblastoma and rhabdomyosarcoma;
however, we may not be able to realize any value from such
designation. |
|
· |
We are exposed to product, clinical and preclinical liability
risks that could create a substantial financial burden should we be
sued. |
|
· |
Acceptance of our products in the marketplace is uncertain and
failure to achieve market acceptance will prevent or delay our
ability to generate revenues. |
|
· |
The market for our proposed products is rapidly changing and
competitive, and new therapeutics, drugs and treatments that may be
developed by others could impair our ability to develop our
business or become competitive. |
|
· |
We may face litigation from third parties claiming that our
products infringe on their intellectual property rights,
particularly because there is often substantial uncertainty about
the validity and breadth of medical patents. |
|
· |
If we are unable to adequately protect or enforce our rights to
intellectual property or to secure rights to third-party patents,
we may lose valuable rights, experience reduced market share,
assuming any, or incur costly litigation to protect our
intellectual property rights. |
|
· |
Conflicts, military actions, terrorist attacks, natural
disasters. public health crises, including the occurrence of a
contagious disease or illness, such as the COVID-19 coronavirus,
cyber-attacks and general instability could adversely affect our
business. |
|
· |
Confidentiality agreements with employees and others may not
adequately prevent disclosure of our trade secrets and other
proprietary information and may not adequately protect our
intellectual property, which could limit our ability to
compete. |
|
· |
We may be subject to claims that our employees have wrongfully
used or disclosed alleged trade secrets of their former
employers. |
|
· |
Due to continued changes in marketing, sales and distribution,
we may be unsuccessful in our efforts to sell our proposed
products, develop a direct sales organization, or enter into
relationships with third parties. |
|
· |
If we are unable to convince physicians of the benefits of our
intended products, we may incur delays or additional expense in our
attempt to establish market acceptance. |
|
· |
If users of our products are unable to obtain adequate
reimbursement from third-party payors, or if additional healthcare
reform measures are adopted, it could hinder or prevent the
commercial success of our product candidates. |
|
· |
Our business and operations may be materially, adversely
affected in the event of computer system failures or security
breaches. |
|
· |
Failure to maintain effective internal controls could adversely
affect our ability to meet our reporting requirements. |
|
· |
We have in the past received notices from Nasdaq of
noncompliance with its listing rules, and delisting with Nasdaq
could impact the price of our common stock and our ability to raise
funds. |
|
· |
Our stock price has experienced price fluctuations. |
|
· |
Our common stock could be further diluted as the result of the
issuance of additional shares of common stock, convertible
securities, warrants or options. |
|
· |
Provisions of our certificate of incorporation, by-laws, and
Delaware law may make an acquisition of us or a change in our
management more difficult. |
|
· |
We have not paid dividends in the past and do not expect to pay
dividends for the foreseeable future. Any return on investment may
be limited to the value of our common stock. |
|
· |
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. |
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.
Description of the December 2020 Financing
On December 23, 2020, we entered into an underwriting
agreement (the “Underwriting Agreement”) with
Oppenheimer & Co. Inc. as representative of the several
underwriters named therein (the “Representative”). Pursuant to the
Underwriting Agreement, the Company agreed to sell to the
Representative 18,148,136 shares of common stock (the “Common
Shares”), par value $0.00001 per share, of the Company (“Common
Stock”) at a public offering price of $1.35 per share of common
stock, prior to deducting underwriting discounts and commissions
and estimated offering expenses (the “Public Offering”). The Common
Shares in the Public Offering were offered pursuant to a
registration statement on Form S-3 (File No. 333-244362),
which was declared effective by the Securities and Exchange
Commission on August 20, 2020.
On December 23, 2020, in a separate concurrent private
placement, the Company entered into a Securities Purchase Agreement
(the “Purchase Agreement”) with certain purchasers named therein
(the “Purchasers”), pursuant to which the Company agreed to issue
and sell, 1,518.5180 Series D Preferred Shares. The
Series D Preferred Shares are convertible into a number of
shares of common stock equal to $13,500 divided by $1.35 (or 10,000
shares of common stock for each share of Series D Preferred
Stock converted), at a price of $13,500 per share of Series D
Preferred Stock (the “PIPE” and together with the Public Offering,
the “Offerings”). The Series D Preferred Shares will only be
convertible into common stock upon receipt of stockholder approval
of the issuance of the underlying shares of common stock as
required by Nasdaq Marketplace Rule 5635(d) at a special
stockholder meeting to be called for that purpose. Pursuant to the
Purchase Agreement, the Company agreed to hold a special meeting of
stockholders on February 25, 2021 for the purpose of obtaining
Stockholder Approval.
The net proceeds of the Offerings to the Company, after deducting
the underwriting discounts and commissions, placement agency fees
and estimated offering expenses payable by the Company were
approximately $41.4 million.
In connection with the entry into the Purchase Agreement, the
Company and the Purchasers entered into a registration rights
agreement (the “Registration Rights Agreement”), pursuant to which
the Company is required to file a registration statement on
Form S-1 or Form S-3 within 30 calendar days of the
closing of the PIPE to provide for the resale of the shares of
Common Stock issuable upon the exercise of the Series D
Preferred Shares. We filed the registration statement on
Form S-3, of which this prospectus is a part to fulfill our
contractual obligations under the Purchase Agreement to provide for
the resale by the Purchasers of up to 15,185,180 shares of Common
Stock issuable upon conversion of the Series D Preferred
Shares. The Company will be obligated to use its reasonable best
efforts to keep any registration statement effective until the
earlier of (a) the date on which the shares of Common Stock
issuable upon the exercise of the Series D Preferred Shares
subject to the registration statement may be sold without
registration pursuant to Rule 144 under the Securities Act, or
(b) the date on which all of the shares of Common Stock
subject to the registration statement have been sold under the
registration statement or without volume or manner-of-sale
restrictions pursuant to Rule 144 under the Securities Act or
any other rule of similar effect.
The Offering
Shares of common stock offered by us: |
|
None |
|
|
|
Shares of common stock offered by the Selling
Stockholders: |
|
15,185,180 shares of Common Stock |
|
|
|
Shares of common stock outstanding before this offering: |
|
45,447,729 |
|
|
|
Shares of common stock outstanding after completion of this
offering, assuming full conversion of the Series D Preferred
Shares |
|
60,632,909 shares |
|
|
|
Use of Proceeds: |
|
We will not receive any proceeds from the resale of the shares
of common stock by the Selling Stockholders. |
|
|
|
Risk Factors: |
|
See “Risk Factors” on page 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 |
The number of shares of our common stock outstanding before and
after this offering is based on 45,447,729 shares of common stock
outstanding as of January 15, 2021 and excludes, as of that
date:
|
· |
an aggregate of 1,215,464 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; and |
|
· |
an aggregate of 17,451,266 additional shares of common stock
reserved for issuance under outstanding warrants having expiration
dates between April 1, 2021, and June 5, 2025, and
exercise prices ranging from $1.21 to $30.40 per share. |
Unless otherwise noted, the information in this prospectus reflects
and assumes no exercise of outstanding options and warrants or
conversion of shares of preferred stock.
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. 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.
USE OF PROCEEDS
All proceeds from the resale of the shares of common stock
underlying the Series D Preferred Shares offered by this
prospectus will belong to the Selling Stockholders. We will not
receive any proceeds from the sale or other disposition by the
Selling Stockholders of the shares of our common stock covered by
this prospectus.
SELLING STOCKHOLDERS
The Common Stock being offered by the Selling Stockholders are
those issuable to the Selling Stockholders upon conversion of the
Series D Preferred Shares. We are registering the shares of
common stock in order to permit the Selling Stockholders to offer
the shares for resale from time to time upon obtaining the
Stockholder Approval. For additional information regarding the
issuance of Series D Preferred Shares, see "Description of the
December 2020 Financing" above. Except for the ownership of
the Series D Preferred Shares and the purchase of securities
in prior financings in the case of some Selling Stockholders, the
Selling Stockholders have not had any material relationship with us
within the past three years.
The table below lists the Selling Stockholders and other
information regarding the beneficial ownership of the shares of
common stock by each of the Selling Stockholders. The second column
lists the number of shares of common stock beneficially owned by
each Selling Stockholder, based on its ownership of the
Series D Preferred Shares, assuming conversion of the
Series D Preferred Shares held by the Selling
Stockholders.
The third column lists the shares of common stock being offered by
this prospectus by the Selling Stockholders.
In accordance with the terms of the Registration Rights Agreement
with the Selling Stockholders, this prospectus generally covers the
resale of the maximum number of shares of common stock issuable
upon conversion of the Series D Preferred Shares, determined
as if the outstanding Series D Preferred Shares were converted
in full as of the trading day immediately preceding the date this
registration statement was initially filed with the SEC, each as of
the trading day immediately preceding the applicable date of
determination and all subject to adjustment as provided in the
Registration Rights Agreement.
The fourth column assumes the sale of all of the shares offered by
the Selling Stockholders pursuant to this prospectus.
Under the terms of the Series D Preferred Shares, a Selling
Stockholder may not convert the Series D Preferred Shares to the
extent such conversion would cause such Selling Stockholder,
together with its affiliates and attribution parties, to
beneficially own a number of shares of common stock which would
exceed 4.99% (or at the election of the Selling Stockholder, 9.99%)
of our then outstanding common stock following such conversion,
excluding for purposes of such determination shares of common stock
issuable upon conversion of the Series D Preferred Shares that have
not been converted. The number of shares in the second and fourth
columns do not reflect this limitation. The Selling Stockholders
may sell all, some or none of their shares in this offering. See
"Plan of Distribution." The percentage of beneficial ownership
after this offering is based on 60,632,909 shares outstanding as of
January 15, 2021 assuming all Series D Preferred Shares have been
sold in this offer.
Name
of Selling Stockholder (1) |
|
Number of
Shares of
Common Stock
Owned
Prior to Offering |
|
|
Maximum Number
of
Shares of Common Stock
to be Sold
Pursuant to this
Prospectus |
|
|
Number of Shares
of
Common Stock
Owned
After Offering |
|
|
Percentage of
Common
Stock Owned
After Offering |
|
Consonance Capital Management LP |
|
|
11,111,111
(2) |
|
|
|
7,037,037 |
|
|
|
4,074,074 |
|
|
|
6.72 |
% |
SilverArc Capital Alpha Fund I, L.P. |
|
|
150,681
(3) |
|
|
|
103,222 |
|
|
|
47,459 |
|
|
|
* |
|
SilverArc Capital Alpha Fund II, L.P. |
|
|
1,325,103 (4) |
|
|
|
936,111 |
|
|
|
388,992 |
|
|
|
* |
|
2B LLC |
|
|
101,605
(5) |
|
|
|
71,778 |
|
|
|
29,827 |
|
|
|
* |
|
Laurence Lytton |
|
|
5,305,355
(6) |
|
|
|
1,296,296 |
|
|
|
4,009,059 |
|
|
|
7.26 |
% |
CVI
Investments, Inc. |
|
|
2,440,517
(7) |
|
|
|
925,925 |
|
|
|
1,514,592 |
|
|
|
2.50 |
% |
Investor Company ITF Rosalind Master Fund L.P. |
|
|
2,068,511
(8) |
|
|
|
1,111,111 |
|
|
|
957,400 |
|
|
|
1.58 |
% |
683
Capital Partners, LP |
|
|
1,851,850
(9) |
|
|
|
925,925 |
|
|
|
925,925 |
|
|
|
1.53 |
% |
Altium
Growth Fund, LP |
|
|
1,992,592
(10) |
|
|
|
740,740 |
|
|
|
1,251,852 |
|
|
|
2.06 |
% |
AIGH
Investment Partners L.P. |
|
|
1,448,573
(11) |
|
|
|
553,036 |
|
|
|
895,537 |
|
|
|
1.48
|
% |
WVP
Emerging Manager Onshore Fund, LLC – AIGH Series |
|
|
296,311
(12) |
|
|
|
143,704 |
|
|
|
152,607 |
|
|
|
* |
|
WVP
Emerging Manager Onshore Fund, LLC
– Optimized Equity Series |
|
|
90,956
(13) |
|
|
|
44,000 |
|
|
|
46,956 |
|
|
|
* |
|
Lincoln Park Capital Fund, LLC |
|
|
2,302,378
(14) |
|
|
|
555,555 |
|
|
|
1,746,823 |
|
|
|
2.88 |
% |
Maven
Investment Partners US Limited |
|
|
1,111,110
(15) |
|
|
|
370,370 |
|
|
|
740,740 |
|
|
|
1.22 |
% |
Granite Point Capital Panacea Global Healthcare Fund |
|
|
888,888
(16) |
|
|
|
370,370 |
|
|
|
518,518 |
|
|
|
* |
|
* Less than one percent.
(1) |
This table and the information in the notes below are based
upon information supplied by the selling stockholders as of
January 15, 2021. |
(2) |
Consonance Capital Opportunity Master Fund, LP (“Consonance
Opportunity Master”) directly holds 3,031,111 shares of Common
Stock and 5,235,556 shares of Common Stock issuable upon conversion
of Series D Preferred Shares (the “Opportunity Master Account
Shares”). An account (the “Managed Account”) managed by Consonance
Capital Management LP (the “Adviser”) directly holds 1,042,963
shares of Common Stock and 1,801,481 shares of Common Stock
issuable upon conversion of Series D Preferred Shares (the
“Managed Account Shares”). The Adviser is the investment adviser of
Consonance Opportunity Master and the Managed Account, and pursuant
to investment advisory agreements, the Adviser exercises voting and
investment power over the Opportunity Master Account Shares
directly held by Consonance Opportunity Master and the Managed
Account Shares directly held by the Managed Account. Consonance
Capman GP LLC (“Capman”) is the general partner of the Adviser and
Mitchell Blutt, as the Manager & Member of Capman and
Chief Executive Officer of the Adviser, may be deemed to control
Capman and the Adviser. Each of the Adviser, Capman and
Mr. Blutt may be deemed to beneficially own the Opportunity
Master Account Shares and the Managed Account Shares. The address
for the Adviser, Capman and Mr. Blutt is 1370 Avenue of the
Americas, Floor 33, New York, NY 10019. |
|
|
(3) |
Consists of 47,459 shares of Common Stock and 103,222 shares of
Common Stock issuable upon conversion of Series D Preferred
Shares. SilverArc Capital Management, LLC is the investment adviser
to SilverArc Capital Alpha Fund I, L.P. The address for
SilverArc Capital Management, LLC is 20 Park Plaza, 4th Floor,
Boston, Massachusetts 02116. |
|
|
(4) |
Consists of 388,992 shares of Common
Stock and 936,111 shares of Common Stock issuable upon conversion
of Series D Preferred Shares. SilverArc Capital Management,
LLC is the investment adviser to SilverArc Capital Alpha Fund II,
L.P. The address for SilverArc Capital Management, LLC
is 20 Park Plaza, 4th Floor, Boston, Massachusetts 02116. |
(5) |
Consists of 29,827 shares of Common Stock and 71,778 shares of
Common Stock issuable upon conversion of Series D Preferred
Shares. SilverArc Capital Management, LLC is the investment adviser
to 2B LLC. The address for SilverArc Capital Management,
LLC is 20 Park Plaza, 4th Floor, Boston, Massachusetts 02116. |
(6) |
Consists of 2,270,059 shares of Common Stock, 1,739,000 shares of
Common Stock issuable upon exercise of outstanding warrants and
1,296,296 shares of Common Stock issuable upon conversion of
Series D Preferred Shares. The address of Mr. Lytton is
467 Central Park West, New York, New York 10025.
|
(7) |
Consists of 1,514,592 shares of Common Stock issuable upon
exercise of outstanding warrants and 925,925 shares of Common Stock
issuable upon conversion of Series D Preferred Shares. Heights
Capital Management, Inc., the authorized agent of CVI
Investments, Inc. ("CVI"), has discretionary authority to vote
and dispose of the shares held by CVI and may be deemed to be the
beneficial owner of these shares. Martin Kobinger, in his capacity
as Investment Manager of Heights Capital Management, Inc., may
also be deemed to have investment discretion and voting power over
the shares held by CVI. Mr. Kobinger disclaims any such
beneficial ownership of the shares. CVI is affiliated with one or
more FINRA member, none of whom are currently expected to
participate in the ale pursuant to the prospectus contained in the
Registration Statement of shares purchased by the investor in this
offering. The principal address of Heights Capital
Management, Inc. is 101 California Street, Suite 3250,
San Francisco, CA 94111. |
(8) |
Consists of 544,300 shares of Common Stock, 413,060 shares of
Common Stock issuable upon exercise of outstanding warrants and
1,111,111 shares of Common Stock issuable upon conversion of Series
D Preferred Shares. Rosalind Advisors, Inc. is the investment
advisor to Rosalind Master Fund L.P. and may be deemed the
beneficial owner of shares held by Rosalind Master Fund L.P. Steven
Salamon is the portfolio manager of Rosalind Advisors, Inc. and may
be deemed to beneficially own the securities held by Rosalind
Master Fund L.P. The address of each of Investor Company ITF
Rosalind Master Fund L.P., Rosalind Advisors, Inc. and Mr. Salamon
is c/o TD Waterhouse, 77 Bloor Street West, 3rd Floor,
Toronto, ON M5S 1M2, Canada. |
(9) |
Consists of 925,925 shares of Common Stock and 925,925 shares
of Common Stock issuable upon conversion of Series D Preferred
Shares. 683 Capital Management, LLC is the investment manager of
683 Capital Partners, LP and may be deemed to have beneficial
ownership over the securities held by 683 Capital Partners, LP. Ari
Zweiman, as the managing member of 683 Capital Management, LLC, may
be deemed to beneficially own the securities held by 683 Capital
Partners, LP. The address of 683 Capital Partners, L.P., 683
Capital Management LLC and Avi Zweiman is 3 Columbus Circle,
Suite 2205, New York, NY 10019. |
(10) |
Consists of 851,852 shares of Common Stock, 400,000 shares of
Common Stock issuable upon exercise of outstanding warrants and
740,740 shares of Common Stock issuable upon conversion of
Series D Preferred Shares. Altium Capital Management, LP, the
investment manager of Altium Growth Fund, LP, has voting and
investment power over these securities. Jacob Gottlieb is the
managing member of Altium Capital Growth GP, LLC, which is the
general partner of Altium Growth Fund, LP. Each of Altium Growth
Fund, LP and Jacob Gottlieb disclaims beneficial ownership over
these securities. The principal address of Altium Capital
Management, LP is 152 West 57 Street, 20th Floor New York, New York
10019. |
(11) |
Consists of 895,537 shares of Common Stock issuable upon
exercise of outstanding warrants and 553,036 shares of Common Stock
issuable upon conversion of Series D Preferred Shares. AIGH
Capital Management (“AIGH CM”) is the Investment Advisor or
Sub-Advisor to AIGH Investment Partners LP (“AIGH LP”) and may be
deemed to have beneficial ownership over the securities held by
AIGH LP. Orin Hirschman is the Manager of AIGH CM and may be deemed
to have beneficial ownership over the securities held by AIGH CM.
The address for Orin Hirschman, AIGH CM and AIGH L.P. is
6006 Berkeley Avenue, Baltimore, Maryland, 21209. |
(12) |
Consists of 152,607 shares of Common Stock issuable upon
exercise of outstanding warrants and 143,704 shares of Common Stock
issuable upon conversion of Series D Preferred Shares. AIGH
Capital Management (“AIGH CM”) is the Investment Advisor or
Sub-Advisor to WVP Emerging Manager Onshore Fund, LLC – AIGH
Series (“WVP AIGH”) and may be deemed to have beneficial
ownership over the securities held by WVP AIGH. Orin Hirschman is
the Manager of AIGH CM and may be deemed to have beneficial
ownership over the securities held by AIGH CM. The address for Orin
Hirschman, AIGH CM, and WVP AIGH is 6006 Berkeley Avenue,
Baltimore, Maryland, 21209. |
(13) |
Consists of 46,956 shares of Common Stock issuable upon
exercise of outstanding warrants and 44,000 shares of Common Stock
issuable upon conversion of Series D Preferred Shares. AIGH
Capital Management (“AIGH CM”) is the Investment Advisor or
Sub-Advisor to WVP Emerging Manager Onshore Fund, LLC – Optimized
Equity Series (“WVP OE”) and may be deemed to have beneficial
ownership over the securities held by WVP OE. Orin Hirschman is the
Manager of AIGH CM and may be deemed to have beneficial ownership
over the securities held by AIGH CM. The address for Orin
Hirschman, AIGH CM, and WVP OE is 6006 Berkeley Avenue, Baltimore,
Maryland, 21209. |
(14) |
Consists of 1,746,823 shares of Common Stock issuable upon
exercise of outstanding warrants and 555,555 shares of Common Stock
issuable upon conversion of Series D Preferred Shares. Lincoln
Park Capital, LLC is the managing member of Lincoln Park Capital
Fund, LLC. Rockledge Capital Corporation and Alex Noah
Investors, Inc. are the managing members of Lincoln Park
Capital, LLC. Joshua Scheinfeld is the president and sole
shareholder of Rockledge Capital Corporation, as well as a
principal of Lincoln Park Capital, LLC. Jonathan Cope is the
president and sole shareholder of Alex Noah Investors, Inc.,
as well as a principal of Lincoln Park Capital, LLC. As a result of
the foregoing, Mr. Scheinfeld and Mr. Cope have shared
voting and shared investment power over the securities held
directly by Lincoln Park Capital Fund, LLC. The principal address
of Lincoln Park Capital Fund, LLC is 440 N. Wells St.,
Suite 410, Chicago, IL 60654. |
(15) |
Consists of 740,740 shares of Common Stock and
370,370 shares of Common Stock issuable upon conversion of
Series D Preferred Shares Anand K. Sharma may be deemed to
have investment discretion and voting power over the shares held by
Maven Investment Partners US Ltd. The address of Maven is 675 3rd
Ave., 15th Floor, New York, New York 10017. |
(16) |
Consists of 518,518 shares of Common Stock and 370,370 shares
of Common Stock issuable upon conversion of Series D Preferred
Shares. The address
for Granite Point Capital Panacea Global Healthcare Fund
is 109 State Street, 5th Floor, Boston, MA
02109. |
PLAN OF DISTRIBUTION
Each Selling Stockholder of the securities and any of their
pledgees, assignees and successors-in-interest may, from time to
time, sell any or all of their securities covered hereby on the
Nasdaq Stock Market or any other stock exchange, market or trading
facility on which the securities are traded or in private
transactions. These sales may be at fixed or negotiated prices. A
Selling Stockholder may use any one or more of the following
methods when selling securities:
|
· |
ordinary brokerage transactions and transactions in which the
broker-dealer solicits purchasers; |
|
· |
block trades in which the
broker-dealer will attempt to sell the securities as agent but may
position and resell a portion of the block as principal to
facilitate the transaction; |
|
· |
purchases by a broker-dealer as
principal and resale by the broker-dealer for its account; |
|
· |
an exchange distribution in accordance with the rules of
the applicable exchange; |
|
· |
privately negotiated transactions; |
|
· |
settlement of short sales; |
|
· |
in transactions through broker-dealers
that agree with the Selling Stockholders to sell a specified number
of such securities at a stipulated price per security; |
|
· |
through the writing or settlement
of options or other hedging transactions, whether through an
options exchange or otherwise; |
|
· |
a combination of any such methods of sale; or |
|
· |
any other method permitted pursuant to applicable law. |
The Selling Stockholders may also sell securities under
Rule 144 or any other exemption from registration under the
Securities Act, if available, rather than under this
prospectus.
Broker-dealers engaged by the Selling Stockholders may arrange for
other broker-dealers to participate in sales. Broker-dealers may
receive commissions or discounts from the Selling Stockholders (or,
if any broker-dealer acts as agent for the purchaser of securities,
from the purchaser) in amounts to be negotiated, but, except as set
forth in a supplement to this Prospectus, in the case of an agency
transaction not in excess of a customary brokerage commission in
compliance with FINRA Rule 2440; and in the case of a
principal transaction a markup or markdown in compliance with FINRA
IM-2440.
In connection with the sale of the securities or interests therein,
the Selling Stockholders may enter into hedging transactions with
broker-dealers or other financial institutions, which may in turn
engage in short sales of the securities in the course of hedging
the positions they assume. The Selling Stockholders may also sell
securities short and deliver these securities to close out their
short positions, or loan or pledge the securities to broker-dealers
that in turn may sell these securities. The Selling Stockholders
may also enter into option or other transactions with
broker-dealers or other financial institutions or create one or
more derivative securities which require the delivery to such
broker-dealer or other financial institution of securities offered
by this prospectus, which securities such broker-dealer or other
financial institution may resell pursuant to this prospectus (as
supplemented or amended to reflect such transaction).
The Selling Stockholders and any broker-dealers or agents that are
involved in selling the securities may be deemed to be
“underwriters” within the meaning of the Securities Act in
connection with such sales. In such event, any commissions received
by such broker-dealers or agents and any profit on the resale of
the securities purchased by them may be deemed to be underwriting
commissions or discounts under the Securities Act. Each Selling
Stockholder has informed the Company that it does not have any
written or oral agreement or understanding, directly or indirectly,
with any person to distribute the securities.
The Company is required to pay certain fees and expenses incurred
by the Company incident to the registration of the securities. The
Company has agreed to indemnify the Selling Stockholders against
certain losses, claims, damages and liabilities, including
liabilities under the Securities Act.
We agreed to keep this prospectus effective until the earlier of
(i) the date on which the securities may be resold by the
Selling Stockholders without registration and without regard to any
volume or manner-of-sale limitations by reason of Rule 144,
without the requirement for the Company to be in compliance with
the current public information under Rule 144 under the
Securities Act or any other rule of similar effect, or
(ii) all of the securities have been sold pursuant to this
prospectus or Rule 144 under the Securities Act or any other
rule of similar effect. The resale securities will be sold
only through registered or licensed brokers or dealers if required
under applicable state securities laws. In addition, in certain
states, the resale securities covered hereby may not be sold unless
they have been registered or qualified for sale in the applicable
state or an exemption from the registration or qualification
requirement is available and is complied with.
Under applicable rules and regulations under the Exchange Act,
any person engaged in the distribution of the resale securities may
not simultaneously engage in market making activities with respect
to the common stock for the applicable restricted period, as
defined in Regulation M, prior to the commencement of the
distribution. In addition, the Selling Stockholders will be subject
to applicable provisions of the Exchange Act and the rules and
regulations thereunder, including Regulation M, which may limit the
timing of purchases and sales of the common stock by the Selling
Stockholders or any other person. We will make copies of this
prospectus available to the Selling Stockholders and have informed
them of the need to deliver a copy of this prospectus to each
purchaser at or prior to the time of the sale (including by
compliance with Rule 172 under the Securities Act).
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:
|
· |
our Annual Report on Form 10-K for the fiscal year ended
December 31, 2019, filed with the SEC on
March 9, 2020; |
|
· |
our Quarterly Report on Form 10-Q for the quarter year ended
March 31, 2020, filed with the SEC on
May 7, 2020; |
|
· |
our Quarterly Report on Form 10-Q for the quarter year ended
June 30, 2020, filed with the SEC on
August 10, 2020; |
|
· |
our Quarterly Report on Form 10-Q for the quarter year ended
September 30, 2020, filed with the SEC on November 9, 2020; |
|
· |
our Definitive Proxy Statement on Schedule 14A for the annual
meeting of stockholders, filed with the SEC on
April 28, 2020; |
|
· |
our Current Report on Form 8-K, filed with the SEC on
May 26, 2020; |
|
· |
our Current Report on Form 8-K, filed with the SEC on
June 1, 2020; |
|
· |
our Current Report on Form 8-K, filed with the SEC on
June 5, 2020; |
|
· |
our Current Report on Form 8-K, filed with the SEC on
June 25, 2020; |
|
· |
our Current Report on Form 8-K, filed with the SEC on
July 1, 2020; |
|
· |
the description of our securities
contained in our Registration Statement on Form 8-A filed on
April 18, 2016, including any amendment or report filed for the
purpose of updating such description. |
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, or that
information to which this prospectus or any prospectus 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.
15,185,180 Shares of Common Stock Issuable upon Conversion of
Series D Preferred Stock
PROSPECTUS
January ,
2021
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 |
|
$ |
3,272 |
|
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. |
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 |
|
Form of Certificate of Designation of
Series D Preferred Stock |
|
8-K |
|
December 28, 2020 |
|
3.1 |
3.9 |
|
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
Series D Preferred Stock Certificate |
|
8-K |
|
December 28, 2020 |
|
4.1 |
10.1 |
|
Form of Securities Purchase
Agreement |
|
8-K |
|
December 28, 2020 |
|
10.1 |
10.2 |
|
Form of Registration Rights
Agreement |
|
8-K |
|
December 28, 2020 |
|
10.2 |
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) |
|
|
|
|
|
|
* |
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:
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(i) |
Any preliminary prospectus or prospectus of the undersigned
registrant relating to the offering required to be filed pursuant
to Rule 424; |
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(ii) |
Any free writing prospectus relating to the offering prepared
by or on behalf of the undersigned registrant or used or referred
to by the undersigned registrant; |
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(iii) |
The portion of any other free writing prospectus relating to
the offering containing material information about the undersigned
registrant or its securities provided by or on behalf of the
undersigned registrant; and |
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(iv) |
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 January 21, 2021.
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CELLECTAR
BIOSCIENCES, INC. |
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By: |
/s/ James V. Caruso |
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James V. Caruso |
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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 |
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Title |
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Date |
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/s/James V. Caruso |
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Chief Executive Officer and
Director |
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January 21, 2021 |
James
V. Caruso |
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(principal executive officer) |
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/s/ Dov Elefant |
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Chief
Financial Officer |
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January 21, 2021 |
Dov
Elefant |
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(principal financial officer
and |
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principal accounting officer) |
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/s Frederick W. Driscoll |
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Director |
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January 21, 2021 |
Frederick W. Driscoll |
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/s/ Stephen A. Hill |
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Director |
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January 21, 2021 |
Stephen A. Hill |
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/s/ Stefan D. Loren,
Ph.D. |
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Director |
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January 21, 2021 |
Stefan D. Loren, Ph.D. |
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/s/ John Neis |
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Director |
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January 21, 2021 |
John
Neis |
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/s/ Douglas J. Swirsky |
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Director |
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January 21, 2021 |
Douglas J. Swirsky |
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