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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): January 12, 2025
Cellectar Biosciences, Inc.
(Exact name of Registrant as Specified in its
Charter)
Delaware | |
1-36598 | |
04-3321804 |
(State or other jurisdiction
of incorporation) | |
(Commission
File Number) | |
(IRS Employer
Identification No.) |
100
Campus Drive, Florham Park, NJ, 07932
(Address of principal executive offices) (Zip
Code)
Registrant’s telephone number, including
area code: (608) 441-8120
N/A
(Former Name or Former Address, if Changed
Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading
Symbol(s) |
|
Name of each exchange
on which registered |
Common Stock, par value $0.00001 per share |
|
CLRB |
|
The Nasdaq Capital
Market |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
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 pursuant
to Section 13(a) of the Exchange Act. ¨
Item 7.01. |
Results of Operations and Financial Condition. |
On
January 12, 2025, we issued a press release with an overview of the Company’s 2025 strategic initiatives that we will be presenting
at Biotech Showcase during the JP Morgan healthcare conference. A copy of the press release
is furnished as Exhibit 99.1 and is incorporated by reference herein.
Item 9.01. |
Financial Statements and Exhibits |
(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
CELLECTAR BIOSCIENCES, INC. |
|
|
|
Date: January 14, 2025 |
By: |
/s/ Chad J. Kolean |
|
Name: |
Chad J. Kolean |
|
Title: |
Chief Financial Officer |
Exhibit 99.1
Cellectar Biosciences
to Highlight 2025 Strategic Initiatives at Upcoming
Biotech Showcase during the JP Morgan Healthcare Conference
Oral Presentation
Presented at ASH 2024 Showed Iopofosine I 131 Achieved an 83.6% ORR and Exceeded Primary and Secondary Efficacy Endpoints in Phase 2 CLOVER-WaM
Study for Relapsed/Refractory Waldenstrom’s Macroglobulinemia
Plans to
Advance Iopofosine I 131 Internally, Through Strategic Partnerships and Other Approaches; Finalizing Confirmatory Study and Pathway for
US FDA Accelerated Approval and EMA Prime Marketing Authorization
Advancing Radiotherapeutic
Assets including Alpha- and Auger-emitting Radioconjugates into Phase 1/2a Solid Tumor Studies
Florham Park, N.J., January 12, 2025 (GLOBE NEWSWIRE) -- Cellectar
Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization
of drugs for the treatment of cancer, today announces plans to highlight the Company’s 2025 strategic initiatives at Biotech Showcase,
taking place January 13-15, 2025 in San Francisco during the 43rd Annual JP Morgan Healthcare Conference. James Caruso,
president and CEO of Cellectar, will present a corporate update on Tuesday, January 14, 2025, at 11:30 am Pacific Time.
Iopofosine I 131 (iopofosine) is a potential first-in-class, novel
cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy. The CLOVER-WaM study (NCT02952508) results demonstrated
an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2% (95% CI, 0.42 to 0.67), which exceeded the agreed-upon
primary endpoint of a 20% MRR. These data were presented as a podium presentation during the 66th Annual American Society of Hematology
Conference in December 2024 by Sikander Ailawadhi, M.D., Professor of Medicine, Mayo Clinic.
“We remain committed to bringing iopofosine to WM patients, who
have limited treatment options for this incurable disease,” said James Caruso, president and CEO of Cellectar. “We believe
our ongoing communications with the U.S. Food and Drug Administration (FDA) indicate there is a path forward for a conditional U.S. market
approval as part of the accelerated approval process. This aligns with our understanding of feedback provided by the European Medicines
Agency for conditional EU market authorization, and we are harmonizing recommendations from both agencies for a global approval strategy.”
The Company expects the confirmatory study to be a comparator, randomized
controlled study with 40-60 patients per arm and full patient enrollment projected within 18 months of the first patient admitted to the
study. The Company anticipates alignment with the FDA in the first half of 2025. With a current cash runway extending into the fourth
quarter of 2025, the Company is assessing a variety of approaches to bring iopofosine to patients.
Mr. Caruso continued, “We believe iopofosine represents a compelling
partnership opportunity for many reasons including the results observed from our clinical studies. The commercial work we conducted in
WM provides strong evidence that iopofosine possesses a substantial market opportunity based upon patient outcomes, convenient fixed dosing,
off-the-shelf global distribution, and orphan pricing. Cellectar’s goal to bring lifesaving radioconjugates, such as iopofosine,
CLR 121225, and CLR 121125, to patients remains steadfast and we look forward to advancing our objectives throughout 2025.”
Beyond iopofosine, the Company is focused on the development of its
radioconjugate Phospholipid Drug ConjugateTM (PDC) programs, also known as phospholipid radioconjugates or PRCs. CLR 121225
is Cellectar’s lead alpha-emitting actinium-225 radioconjugate PRC. It has demonstrated activity and has been well tolerated in
multiple solid tumor animal models, including pancreatic, colorectal, and breast cancer. It has also shown excellent biodistribution and
uptake into tumors. In animal models of pancreatic adenocarcinoma, the single lowest dose tested provided tumor stasis, and the highest
dose provided tumor volume reduction. The Company plans to file an Investigational New Drug (IND) application in the first quarter of
2025.
Cellectar’s lead Auger-emitting (iodine-125) PRC, CLR 121125,
has demonstrated tolerability and activity in multiple animal models including triple negative breast cancer. Auger- emitters provide
the greatest precision in targeted radiotherapy as the emissions only travel a few nanometers, therefore it is necessary for the isotope
to be delivered intracellularly. The Company’s novel PDC platform uniquely provides the required targeted delivery. CLR121125 has
received IND clearance and a Phase 1b/2a dose finding study in triple-negative breast cancer is planned.
The Company is evaluating the timing of study initiation for both CLR
121225 and CLR 121125.
Biotech Showcase
A live webcast and a replay of Mr. Caruso’s presentation at
Biotech Showcase will be available on the Company’s investor relations website.
About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical biopharmaceutical
company focused on the discovery, development and commercialization of proprietary drugs for the treatment of cancer, independently
and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid
Drug ConjugateTM (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering
improved efficacy and better safety as a result of fewer off-target effects.
The company’s product pipeline includes lead asset, iopofosine
I 131, a PDC designed to provide targeted delivery of iodine-131 (radioisotope), CLR 121225, an actinium-225 based program being targeted
to several solid tumors with significant unmet need, such as pancreatic cancer, CLR 121125, an iodine-125 Auger-emitting program targeted
in other solid tumors, such as triple negative breast, lung and colorectal, proprietary preclinical PDC chemotherapeutic programs and
multiple partnered PDC assets.
In addition, iopofosine I 131 has been studied in Phase 2b trials for
relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma, and the CLOVER-2 Phase 1b study, targeting pediatric
patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The
FDA has also granted iopofosine I 131 six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various cancer indications.
For more information, please visit www.cellectar.com or join the conversation
by liking and following us on the company’s social media channels: Twitter, LinkedIn, and Facebook.
Forward-Looking Statement Disclaimer
This news release contains forward-looking statements. You can identify
these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend,"
"could," "estimate," "continue," "plans," or their negatives or cognates. These statements are
only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and
results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future
outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among
others, uncertainties related to the ability to raise additional capital, uncertainties related to the disruptions at our sole source
supplier of iopofosine, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful
preclinical development thereof, patient enrollment and the completion of clinical studies, the FDA and EMA review processes and other
government regulation, our ability to obtain regulatory exclusivities, the availability of priority review vouchers, our ability to successfully
develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement.
A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities
and Exchange Commission including our Form 10-K/A for the year ended December 31, 2023, and our Form 10-Q for the quarter ended September
30, 2024. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking
statements.
Investor Contact:
Anne Marie Fields
Precision AQ
212-362-1200
annemarie.fields@precisionaq.com
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Cellectar Biosciences (NASDAQ:CLRB)
Gráfica de Acción Histórica
De Dic 2024 a Ene 2025
Cellectar Biosciences (NASDAQ:CLRB)
Gráfica de Acción Histórica
De Ene 2024 a Ene 2025