Cellectar Biosciences Reports Financial Results for Year Ended 2024 and Provides a Corporate Update
Achieves alignment with U.S. Food and Drug Administration (FDA) on regulatory path for potential accelerated approval of iopofosine I 131 as a treatment for Waldenström macroglobulinemia $(WM)$
Evaluating timing for Phase 1 solid tumor studies; Auger-emitting radioconjugate prepared for Phase 1b; plans to submit an IND for alpha-emitting radioconjugate;
Company to host webcast and conference call at 8:30 AM ET today
FLORHAM PARK, N.J., March 13, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. $(CLRB)$, a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, today announced financial results for the year ended December 31, 2024, and provided a corporate update.
"In 2024 the company showcased the efficacy and safety of iopofosine I 131 for the treatment of relapsed/refractory Waldenström macroglobulinemia. We recently completed a productive meeting with the FDA that established a clear regulatory pathway for the accelerated approval of this promising drug. Based upon this regulatory clarity, the quality of the CLOVER-WaM data, and a robust global market opportunity, we continue to evaluate inbound inquiries regarding a range of collaborations for iopofosine I 131, which we view as an attractive, non-dilutive funding approach." said James Caruso, president and CEO of Cellectar. "In addition, the company received clearance for an IND for our Auger-emitting radioconjugate and will be submitting an IND application for our alpha-emitting radioconjugate. By the middle of 2025 we will be prepared to advance into phase 1 clinical studies for both compounds, in triple negative breast cancer and pancreatic cancer indications, respectively."
2024 and Recent Corporate Highlights
-- Finalized confirmatory study design and regulatory pathway for potential
FDA accelerated approval of iopofosine I 131, the Company's targeted
radiotherapeutic candidate for the treatment of relapsed/refractory WM.
-- The study will be a randomized, controlled trial of iopofosine I
131 versus a comparator arm, with 100 patients per arm.
-- Two-stage approval process includes conditional accelerated
approval based on a major response rate $(MRR.AU)$ endpoint with full
approval based upon achieving a progression-free survival
endpoint.
-- Company expects to complete full patient enrollment within 24
months of the first patient admitted to the study.
-- Total study cost is expected to be between $40M-$45M, with
approximately $30M to full enrollment.
-- Presented data from the Phase 2 CLOVER-WaM study in an oral session at
the 66th American Society of Hematology Annual Meeting and Exposition
(ASH 2024) in December. The oral presentation highlighted that treatment
with iopofosine I 131 in patients suffering from relapsed/refractory WM
demonstrated:
-- overall Response Rate $(ORR.AU)$ was 83.6%;
-- major Response Rate (MRR) was 58.2%, which exceeded the FDA
agreed-upon primary endpoint of 20% MRR;
-- durable efficacy in previously treated WM patients, with no
current standard of care therapy;
-- well tolerated with a manageable toxicity profile across broad
biologic and clinical subgroups.
-- An article published in the journal eBioMedicine, volume 111, 2025,
105496, ISSN 2352-3964 from a SPORE Grant-supported, investigator-led
study utilizing iopofosine I 131 (also known as CLR 131) in combination
with external beam radiation, reported the best overall response from 11
evaluable patients included seven participants with a complete response
(63.6%), one with a partial response (9%), one with stable disease (9%),
and two with disease progression (18%), further supporting iopofosine I
131's therapeutic benefit in solid tumors.
-- Continued development of CLR 121225 and CLR 121125, the Company's
pre-clinical radioconjugate assets, to support Phase 1 solid tumor
studies:
-- The company is prepared to initiate a Phase 1b/2a dose-finding
study with CLR 121125 in triple-negative breast cancer. CLR 121125
is the company's lead Auger-emitting (iodine-125) Phospholipid
Radioconjugate$(TM)$ (PRC) that provides the greatest precision in
targeted radiotherapy as emissions only travel a few nanometers.
-- The company plans to file an IND application in the first half of
2025 for CLR 121225. CLR 121225 is Cellectar' s lead
alpha-emitting (actinium-225) PRC, which has demonstrated activity
in multiple solid tumor animal models, including pancreatic and
colorectal cancer.
2024 Financial Highlights
-- Cash and Cash Equivalents: As of December 31, 2024, the company had cash
and cash equivalents of $23.3 million, compared to $9.6 million as of
December 31, 2023. In 2024, Cellectar executed multiple financial
transactions, including investors' exercise of warrants in January 2024
that generated $44.1 million, and an inducement financing in July 2024,
which included the exercise of existing warrants and the purchase of new
warrants for an additional $19.4 million. The company believes its cash
balance as of December 31, 2024, is adequate to fund its basic budgeted
operations into the fourth quarter of 2025.
-- Research and Development Expenses: R&D expenses for the year ended
December 31, 2024, were approximately $26.1 million, compared to
approximately $27.3 million for the year ended December 31, 2023. The
decrease was primarily a result of the timing of expenditures for our WM
Phase 2 study to support final patient visits, partially offset by the
extensive analytic work necessary to prepare for a planned regulatory
submission, product sourcing, manufacturing, and logistics infrastructure
costs to support multi sourcing for each aspect of iopofosine I 131
production.
-- General and Administrative Expenses: G&A expenses for the year ended
December 31, 2024, were approximately $25.6 million, compared to
approximately $11.7 million for the same period in 2023. The increase was
primarily driven by costs associated with the development of
infrastructure necessary to support potential commercialization,
including the related marketing and personnel costs.
-- Other income and expense: Other income and expense, net, was
approximately $7.3 million of income in 2024, as compared to
approximately $3.9 million of expense in the prior year. These amounts
are almost exclusively non-cash and driven by the issuance and valuation
of equity securities in conjunction with financing activities. The only
cash impact was interest income, which for 2024 improved to approximately
$1.2 million from $0.4 million in the prior year.
-- Net Loss: Net loss for the full year ending December 31, 2024, was $44.6
million or $1.22 per basic share and $1.40 per diluted share, compared
with $42.8 million or $3.50 per basic and diluted share during 2023.
Conference Call & Webcast Details
Cellectar management will host a conference call and webcast today, March 13, 2024, at 8:30 AM Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. A live webcast of the conference call can be accessed in the "Events & Presentations" section of Cellectar's website at www.cellectar.com. A recording of the webcast will be available and archived on the Company's website for approximately 90 days.
About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development 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 Conjugate(TM) (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 its lead assets: 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; and CLR 121125, an iodine-125 Auger-emitting program targeted in solid tumors, such as triple negative breast, lung and colorectal, as well as 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: X, LinkedIn, and Facebook.
Forward Looking Statements 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 review process and other government regulation, our ability to maintain orphan drug designation in the United States for iopofosine, the volatile market for priority review vouchers, our pharmaceutical collaborators' 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 for the year ended December 31, 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.
INVESTORS:
Anne Marie Fields
Precision AQ
212-362-1200
annemarie.fields@precisionaq.com
+++ TABLES FOLLOW +++
CELLECTAR BIOSCIENCES, INC.
CONSOLIDATED BALANCE SHEETS
December 31, December 31,
2024 2023
------------- -------------
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 23,288,607 $ 9,564,988
Prepaid expenses and other
current assets 961,665 888,225
------------ ------------
Total current assets 24,250,272 10,453,213
Property, plant & equipment,
net 757,121 1,090,304
Operating lease right-of-use
asset 436,874 502,283
Other long-term assets 29,780 29,780
------------ ------------
TOTAL ASSETS $ 25,474,047 $ 12,075,580
============ ============
LIABILITIES AND STOCKHOLDERS'
(DEFICIT) EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued
liabilities $ 7,585,340 $ 9,178,645
Warrant liability 1,718,000 16,120,898
Lease liability, current 84,417 58,979
------------ ------------
Total current liabilities 9,387,757 25,358,522
Lease liability, net of
current portion 409,586 494,003
------------ ------------
TOTAL LIABILITIES 9,797,343 25,852,525
------------ ------------
COMMITMENTS AND CONTINGENCIES
(Note 10)
MEZZANINE EQUITY:
Series D convertible preferred
stock, 111.11 shares
authorized; 111.11 shares
issued and outstanding as of
December 31, 2024 and 2023 1,382,023 1,382,023
STOCKHOLDERS' (DEFICIT) EQUITY:
Series E-2 preferred stock,
1,225.00 shares authorized;
35.60 and 319.76 shares
issued and outstanding as of
December 31, 2024 and 2023,
respectively 520,778 4,677,632
Common stock, $0.00001 par
value; 170,000,000 shares
authorized; 46,079,875 and
20,744,110 shares issued and
outstanding as of December
31, 2024 and 2023,
respectively 461 207
Additional paid-in capital 261,115,905 182,924,210
Accumulated deficit (247,342,463) (202,761,017)
------------ ------------
Total stockholders' (deficit)
equity 14,294,681 (15,158,968)
------------ ------------
TOTAL LIABILITIES AND
STOCKHOLDERS' (DEFICIT) EQUITY $ 25,474,047 $ 12,075,580
============ ============
CELLECTAR BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
Year Ended December 31,
------------------------------
2024 2023
------------ ------------
OPERATING EXPENSES:
Research and development $ 26,136,246 $ 27,266,276
General and administrative 25,641,452 11,694,367
----------- -----------
Total operating expenses 51,777,698 38,960,643
----------- -----------
LOSS FROM OPERATIONS (51,777,698) (38,960,643)
----------- -----------
OTHER INCOME (EXPENSE):
Warrant issuance expense (7,743,284) (470,000)
Gain (loss) on valuation of
warrants 13,794,683 (3,787,114)
Interest income 1,210,853 387,147
----------- -----------
Total other income (expense), net 7,262,252 (3,869,967)
----------- -----------
LOSS BEFORE INCOME TAXES (44,515,446) (42,830,610)
INCOME TAX PROVISION (BENEFIT) 66,000 (60,000)
----------- -----------
NET LOSS $(44,581,446) $(42,770,610)
=========== ===========
NET LOSS PER SHARE -- BASIC $ (1.22) $ (3.50)
=========== ===========
NET LOSS PER SHARE -- DILUTED $ (1.40) $ (3.50)
=========== ===========
WEIGHTED-AVERAGE COMMON SHARES
OUTSTANDING -- BASIC 36,622,474 12,221,571
=========== ===========
WEIGHTED-AVERAGE COMMON SHARES
OUTSTANDING -- DILUTED 37,143,769 12,221,571
=========== ===========
(END) Dow Jones Newswires
March 13, 2025 07:05 ET (11:05 GMT)