Cellectar Biosciences Reports Second Quarter 2025 Financial Results and Provides a Corporate Update

Rhea-AI Summary

Cellectar Biosciences (NASDAQ:CLRB) reported Q2 2025 financial results and provided significant updates on its radiopharmaceutical pipeline. The company plans to pursue an FDA NDA submission for iopofosine I 131 to treat Waldenstrom Macroglobulinemia (WM) under accelerated approval, subject to funding and confirmatory trial initiation. The drug received FDA Breakthrough Therapy Designation for WM treatment.

Key financial metrics include cash position of $11.0 million as of June 30, 2025, with an additional $5.8 million raised in July 2025. R&D expenses decreased to $2.4 million from $7.3 million year-over-year, while Q2 net loss was $5.4 million. The company expects current funding to support operations into Q2 2026.

In pediatric high-grade glioma trials, patients receiving minimum dosing showed 5.4 months progression-free survival and 8.6 months overall survival. The company plans to advance CLR 125 into Phase 1 TNBC trials by Q4 2025.

Positive

• Received FDA Breakthrough Therapy Designation for iopofosine I 131 in WM treatment
• Positive clinical data in pediatric high-grade glioma with 100% disease control rate
• Secured $9.5 million in new funding through June/July 2025 financings
• Significant R&D cost reduction from $7.3M to $2.4M year-over-year
• Established long-term multi-isotope supply agreement with Nusano

Negative

• NDA submission dependent on securing additional funding
• Cash position decreased to $11.0M from $23.3M in December 2024
• Net loss of $5.4M in Q2 2025
• Current cash runway only extends into Q2 2026

Insights

Biotechnology & Pharmaceutical Regulatory Expert

Cellectar's advancing FDA approval pathway for WM treatment shows promise but faces funding hurdles despite positive clinical data.

Cellectar Biosciences' regulatory strategy for iopofosine I 131 in Waldenstrom Macroglobulinemia (WM) is taking significant shape. The FDA Breakthrough Therapy Designation they've secured represents a meaningful regulatory milestone that could accelerate review timelines. Their plan to pursue an NDA under the Accelerated Approval pathway is strategically sound given their Phase 2b CLOVER WaM data showing a statistically significant major response rate compared to their null hypothesis of 20%.

However, two critical dependencies exist for their regulatory progress: sufficient funding and initiation of a confirmatory trial. The company has explicitly stated these are preconditions for their NDA submission, signaling potential delays if financial constraints persist. Their fundraising of $9.5 million provides some runway, but likely insufficient for the full regulatory process and confirmatory trial.

On the European front, interactions with the EMA regarding Conditional Market Authorization continue, with a decision expected by early Q4 2025. This dual-track regulatory approach is prudent but execution will depend on resolving the funding challenge.

Their pediatric high-grade glioma trial results showing average progression-free survival of 5.4 months and overall survival of 8.6 months represent meaningful clinical benefit in a devastating disease with few options. The correlation between additional dosing cycles and improved outcomes (8.1 months PFS, 11.5 months OS) suggests dose-response effects that regulators typically view favorably.

The company's partnership discussions for regional/global licensing appear primarily financially motivated rather than capability-driven, further emphasizing their capital constraints as the primary barrier to regulatory advancement.

Oncology Clinical Trials Specialist

Cellectar shows promising clinical data in WM and pediatric brain tumors while advancing solid tumor programs despite financial constraints.

The clinical data from Cellectar's Phase 2b CLOVER WaM trial represents a meaningful breakthrough for Waldenstrom Macroglobulinemia patients. Their radiopharmaceutical approach with iopofosine I 131 has demonstrated statistically significant major response rates with meaningful duration of response. The FDA's Breakthrough Therapy Designation substantiates the clinical significance of these results.

Particularly noteworthy is the new subset analysis of patients who failed Bruton Tyrosine Kinase inhibitor (BTKi) treatment regardless of therapy line. BTKi resistance represents a growing clinical challenge in WM management, and effective post-BTKi options would address a clear unmet need.

The pediatric high-grade glioma (pHGG) data shows promising early signals. All patients receiving ≥55 mCi achieved disease control with average progression-free survival of 5.4 months and overall survival of 8.6 months. The dose-response relationship observed with additional dosing cycles (PFS extending to 8.1 months, OS to 11.5 months) suggests potential for optimizing the therapeutic window. Two objective responses in this typically treatment-resistant population is clinically meaningful.

Their pipeline expansion to solid tumors with CLR 125, an Auger-emitting radiopharmaceutical targeting triple-negative breast cancer (TNBC), represents a logical therapeutic extension. The iodine-125 Auger platform offers theoretical advantages for precise tumor targeting with reduced off-target effects compared to beta and alpha emitters.

The secured isotope supply agreement with Nusano for iodine-125 and actinium-225 indicates foresight in addressing potential supply chain constraints that have historically challenged radiopharmaceutical commercialization. The company's multi-isotope strategy suggests a sophisticated understanding of different radioisotopes' applications for various cancer types.

Financial Analyst

Cellectar faces critical funding challenges despite clinical progress, with cash runway into Q2 2026 requiring strategic partnerships to advance programs.

Cellectar's financial position reveals significant challenges despite promising clinical advancements. Their cash position has deteriorated from $23.3 million (December 2024) to $11.0 million (June 2025), representing a 53% reduction in just six months. The additional $5.8 million raised in July provides some breathing room, but their stated runway into Q2 2026 appears tight given their development ambitions.

The company's quarterly R&D expenses decreased substantially to $2.4 million from $7.3 million year-over-year, reflecting the completion of patient enrollment in their CLOVER WaM trial. Similarly, G&A expenses dropped to $3.6 million from $6.4 million, primarily from reduced commercialization activities and personnel costs. This operational streamlining has improved their quarterly cash burn, but their explicit statements about funding constraints limiting regulatory advancement are concerning.

The net loss of $5.4 million ($3.39 per share) compared to $0.9 million ($0.77 per primary share) in the same period last year shows deteriorating bottom-line performance despite cost-cutting. Their repeated emphasis on needing sufficient funding or collaborations as "precursors" to NDA submission and confirmatory trials signals a critical dependency on external capital.

Their partnership discussions appear primarily motivated by financial necessity rather than strategic value-addition, suggesting potential unfavorable terms if negotiations occur under financial duress. While radiopharmaceuticals represent an attractive and growing market segment, Cellectar's ability to capitalize on their clinical advancements appears contingent on securing substantial additional funding beyond their recent raises.

The company's mention of "non-dilutive capital that preserves stockholder value" suggests awareness of the potentially significant dilution that could result from equity financing at current market conditions, making partnership the clearly preferred route forward.

Intend to Pursue an NDA Submission to the U.S. FDA under Accelerated Approval Pathway for Iopofosine I 131 for the Treatment of Waldenstrom Macroglobulinemia (WM) Subject to Sufficient Funding and Once the Confirmatory Trial is Underway

Continue to Work with the EMA Toward a Potential Submission of Iopofosine I 131 for Conditional Approval in the EU; Decision expected late 3Q early 4Q 2025

On track to advance CLR 125 into Phase 1 TNBC trial 4Q 2025

Company to Hold Webcast and Conference Call at 8:30 AM ET Today

FLORHAM PARK, N.J., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced financial results for the quarter ended June 30, 2025, and provided a corporate update on its promising portfolio of clinical and pre-clinical radiopharmaceutical therapeutics.

Second Quarter and Subsequent Corporate Highlights

• Announces plans to pursue an NDA submission to the FDA for the accelerated approval of iopofosine I 131 as a treatment for WM subject to sufficient funding and once the confirmatory trial is underway
  • The submission would be supported by data from the Phase 2b CLOVER WaM clinical trial demonstrating a statistically significant major response rate compared to a null hypothesis of 20% and meaningful duration of response. The data set now includes the FDA-requested 12-month follow-up results on all patients from the trial and new subset analysis of data from patients immediately following Bruton Tyrosine Kinase inhibitor (BTKi) treatment failures regardless of line of therapy.
  • The Company plans to share these new data at an upcoming medical or scientific conference.
• Granted FDA Breakthrough Therapy Designation for iopofosine I 131, a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy, for the treatment of relapsed/refractory WM.
• Received the EMA response regarding scientific advice on its submission for Conditional Market Authorization (CMA) and continues to work with the EMA toward a potential submission.
  • The submission to EMA included data from the Phase 2b CLOVER WaM clinical trial where the company observed a statistically significant major response rate, meaningful duration of response and integrated summary of safety for all patients treated with iopofosine I 131 for hematologic malignancies.
  • Scheduled a follow-up meeting with the EMA and expect to make a final decision to submit for a CMA late in the third quarter or early in the fourth quarter of 2025.
• Submitted a trial protocol with the FDA for a Phase 1b Dose Finding study of our Auger-emitting radiopharmaceutical, CLR 125, for the treatment of relapsed TNBC. CLR 125 is an iodine-125 Auger-emitting drug candidate targeting solid tumors, such as triple negative breast, lung and colorectal cancers.
• Reported a positive initial data update from the Phase 1 clinical trial of iopofosine I 131 in pediatric patients with relapsed/refractory high-grade glioma (pHGG).
  • All patients receiving a minimum of 55 mCi total administered dose (n=7) experienced an average of 5.4 months of progression free survival (PFS) and 8.6 months of overall survival (OS), ongoing.
  • All patients experienced disease control, which correlates with survival benefit.
  • Three patients who received additional dosing cycles (a minimum of four total infusions) had an average PFS of 8.1 months and an OS of 11.5 months (ranging from 4.9 to 14.9 months), ongoing, with two achieving an objective response.
• In active discussions with multiple potential partners for the regional or global licensing of iopofosine I 131 which are designed to provide funding to support the submission of an NDA for accelerated approval and the required confirmatory study.
• Entered a long-term multi-isotope supply agreement with Nusano to provide Cellectar with iodine-125 and actinium-225 for its clinical studies and future commercial needs.
• Raised nearly $9.5 million through separate June and July 2025 financings. Funds from these financings will be used to advance the Company’s next-generation pipeline of radiopharmaceuticals in solid tumors into the clinic and to continue regulatory engagement and partnership discussions for iopofosine I 131.
  
  

“Throughout the first half of 2025 we made meaningful progress advancing our pipeline of targeted radiopharmaceuticals and are entering the second half with solid momentum and a clear plan,” said James Caruso, president and CEO of Cellectar. “We are encouraged by the recent FDA Breakthrough Therapy Designation and the totality of compelling CLOVER WaM safety and efficacy data. Importantly, our regulatory strategy aligns with the FDA’s recently stated mission to accelerate the delivery of lifesaving medicines to patients battling rare diseases, such as WM.”

“We continue our interactions with the European Medicines Agency (EMA) and are hopeful they will recommend we file for a fast-track, conditional marketing authorization approval. We expect their decision either late third or early in the fourth quarter of 2025. In parallel, we remain in active discussions with multiple potential partners to support the NDA filing for accelerated approval of iopofosine I 131 for the treatment of WM. Currently, we view sufficient funding or collaborations as a precursor to the confirmatory study initiation and submission of an NDA for accelerated approval. Such partnerships may provide non-dilutive capital that preserves stockholder value and could potentially accelerate our path to commercialization across key global markets.”

“Beyond iopofosine, we are making tremendous headway advancing our next-generation pipeline of radiopharmaceuticals targeting solid tumors, such as triple-negative breast cancer (TNBC) and pancreatic cancer. We plan to advance CLR 125 into the clinic by late 2025 or early 2026. The FDA has received our Phase 1 protocol submission for the CLR 125 program. We are excited by the opportunities Cellectar possesses to bring transformative radiopharmaceutical therapies to patients in need and look forward to achieving value-creating milestones throughout the balance of the year and beyond,” concluded Mr. Caruso.

Second Quarter 2025 Financial Highlights

• Cash and Cash Equivalents: As of June 30, 2025, the company had cash and cash equivalents of approximately $11.0 million, compared to $23.3 million as of December 31, 2024, which includes $2.3 million in net proceeds received in connection with the company’s June warrant exercises but does not reflect net proceeds of approximately $5.8 million from the July 2025 offering. The company believes its cash balance as of June 30, 2025, inclusive of the additional funds raised in July, is adequate to fund its basic budgeted operations into the second quarter of 2026.
• Research and Development Expenses: R&D expenses for the three months ended June 30, 2025, were approximately $2.4 million, compared to approximately $7.3 million for the three months ended June 30, 2024. The overall lower expense was primarily driven by decreased clinical project costs and manufacturing and related costs resulting from the conclusion of patient enrollment in our CLOVER WaM Phase 2b clinical trial.
• General and Administrative Expenses: G&A expenses for the three months ended June 30, 2025, were approximately $3.6 million, compared to approximately $6.4 million for the same period in 2024. The reduction was the result of decreased commercialization activities and personnel costs.
• Net Loss: The net loss attributable to common stockholders for the three months ended June 30, 2025, was $5.4 million, or $3.39 per primary and diluted share, compared to $0.9 million, or $0.77 per primary share and $5.43 per diluted share in the three months ended June 30, 2024.

Conference Call & Webcast Details
Cellectar management will host a conference call and webcast today, August 14, 2025, 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™ (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 121125, an iodine-125 Auger-emitting program targeted in other solid tumors, such as triple negative breast, lung and colorectal; CLR 121225, an actinium-225 based program being targeted to several solid tumors with significant unmet need, such as pancreatic cancer; and 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 execute strategic alternatives, identify suitable collaborators, partners, licensees or purchasers for our product candidates and, if we are able to do so, to enter into binding agreements with regard to any of the foregoing, or to raise additional capital to support our operations, or our ability to fund our operations if we are unsuccessful with any of the foregoing. 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, and our Form 10-Q for the quarterly period ending June 30, 2025. 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 TO FOLLOW +++

CELLECTAR BIOSCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
					June 30,							December 31,
					2025							2024
ASSETS
CURRENT ASSETS:
Cash and cash equivalents					$	11,041,027						$		23,288,607
Prepaid expenses and other current assets						1,576,579								961,665
Total current assets						12,617,606								24,250,272
Property, plant & equipment, net						647,549								757,121
Operating lease right-of-use asset						400,248								436,874
Other long-term assets						29,780								29,780
TOTAL ASSETS					$	13,695,183						$		25,474,047
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
CURRENT LIABILITIES:
Accounts payable and accrued liabilities					$	4,678,713						$		7,585,340
Warrant liability						1,095,926								1,718,000
Lease liability, current						92,022								84,417
Total current liabilities						5,866,661								9,387,757
Lease liability, net of current portion						361,487								409,586
TOTAL LIABILITIES						6,228,148								9,797,343
COMMITMENTS AND CONTINGENCIES (Note 7)
MEZZANINE EQUITY:
Series D preferred stock, 111.11 shares authorized, issued and outstanding as of June 30, 2025 and December 31, 2024						1,382,023								1,382,023
STOCKHOLDERS’ EQUITY (DEFICIT):
Series E-2 preferred stock, 1,225 shares authorized; 35.60 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively						520,778								520,778
Common stock, $0.00001 par value; 170,000,000 shares authorized; 1,812,040 and 1,535,996 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively						18								15
Additional paid-in capital						264,958,619								261,116,351
Accumulated deficit						(259,394,403				)				(247,342,463	)
Total stockholders’ equity (deficit)						6,085,012								14,294,681
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)					$	13,695,183						$		25,474,047

CELLECTAR BIOSCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
		Three Months Ended June 30,								Six Months Ended June 30,
		2025				2024				2025				2024
OPERATING EXPENSES:
Research and development		$	2,389,801			$	7,345,480			$	5,816,896			$	14,433,523
General and administrative			3,647,728				6,358,229				6,621,624				11,271,673
Total operating expenses			6,037,529				13,703,709				12,438,520				25,705,196
LOSS FROM OPERATIONS			(6,037,529	)			(13,703,709	)			(12,438,520	)			(25,705,196	)
OTHER INCOME (EXPENSE):
Gain (loss) on valuation of warrants			501,598				12,455,431				161,598				(2,504,915	)
Interest income			88,020				328,907				224,982				648,756
Total other income (expense)			589,618				12,784,338				386,580				(1,856,159	)
NET LOSS		$	(5,447,911	)		$	(919,371	)		$	(12,051,940	)		$	(27,561,355	)
NET LOSS PER SHARE — BASIC		$	(3.39	)		$	(0.77	)		$	(7.66	)		$	(25.38	)
NET LOSS PER SHARE — DILUTED		$	(3.39	)		$	(5.43	)		$	(7.66	)		$	(25.38	)
WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — BASIC			1,608,799				1,193,981				1,572,598				1,086,102
WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — DILUTED			1,608,799				1,248,210				1,572,598				1,086,102

FAQ

What is the status of Cellectar's (CLRB) iopofosine I 131 FDA approval process for WM treatment?

Cellectar plans to pursue an NDA submission under accelerated approval pathway, contingent on securing sufficient funding and initiating the confirmatory trial. The drug has received FDA Breakthrough Therapy Designation for WM treatment.

What were Cellectar Biosciences' (CLRB) key financial results for Q2 2025?

Cellectar reported $11.0M in cash, R&D expenses of $2.4M, and a net loss of $5.4M. The company raised additional $9.5M through June/July 2025 financings.

What clinical results did CLRB report for pediatric high-grade glioma treatment?

Patients receiving minimum dosing (n=7) showed 5.4 months progression-free survival and 8.6 months overall survival. All patients achieved disease control, with extended survival in patients receiving additional dosing cycles.

When does Cellectar (CLRB) expect to receive EMA decision for iopofosine I 131?

Cellectar expects the EMA decision regarding potential submission for Conditional Market Authorization (CMA) in late Q3 or early Q4 2025.

What is CLRB's cash runway following recent financings?

The company's current cash position, including the July 2025 financing, is expected to fund basic operations into Q2 2026.