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01/10 17:31
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call presents a mixed outlook. While there are positive developments such as decreased expenses and strong partnership momentum, significant risks persist, including reliance on rare isotopes and funding needs for trials. The Q&A reveals cautious optimism but lacks concrete guidance and pricing details, which may concern investors. Given the balanced nature of positive and negative factors, a neutral stock price reaction is expected.
Cash and Cash Equivalents $12.6 million as of September 30, 2025, compared to $23.3 million as of December 31, 2024. The decrease is due to operational expenses and investments.
Recent Financing Raised approximately $12.7 million in recent financings, including $5.8 million through issuance of common stock, prefunded warrants, and new common warrants in July 2025, and an additional $5 million net through investors' exercise of certain outstanding warrants.
Research and Development Expenses $2.5 million for Q3 2025, compared to $5.5 million for Q3 2024, a decrease due to lower costs related to the CLOVER-WaM study and reduced manufacturing costs after completing a second manufacturing source for iopofosine.
General and Administrative Expenses $2.3 million for Q3 2025, compared to $7.8 million for Q3 2024, a decrease driven by reduced pre-commercialization and market assessment efforts and lower personnel costs.
Net Loss $4.4 million for Q3 2025, or $1.41 per basic and diluted common share, compared to $14.7 million for Q3 2024, or $11.18 per basic and $12.13 per diluted common share. The reduction is due to lower R&D and G&A expenses.
iopofosine I 131: Continues to show strong promise as a first-in-class radio conjugate therapy for Waldenstrom’s macroglobulinemia (WM). Received confirmation of eligibility to file for conditional marketing approval in the EU based on the CLOVER-WaM study. Plans to submit an NDA under the accelerated approval pathway in the U.S. upon initiation of a confirmatory Phase III trial. Granted breakthrough designation by the FDA for WM.
CLR 125: Initiated Phase Ib study targeting triple-negative breast cancer. The study will evaluate three distinct doses and aims to determine the recommended Phase II dose and dosing regimen. Demonstrated significant tumor uptake and no toxicities in preclinical studies.
CLR 225: Preclinical studies show excellent biodistribution and uptake into solid tumors, including pancreatic and refractory colorectal cancers. Pending financing, a Phase I trial is planned to evaluate biodistribution, safety, and tolerability in pancreatic adenocarcinoma.
Strategic collaborations: Actively discussing partnerships to provide iopofosine I 131 to patients quickly, secure nondilutive capital, and leverage commercial expertise. Collaboration with ITM to secure actinium-225 supply for CLR 225.
Financial position: Raised approximately $12.7 million in recent financings, extending cash runway into Q3 2026. Reduced R&D and G&A expenses compared to the previous year.
Regulatory progress: Maintained consistent dialogue with EMA and FDA, achieving significant milestones for iopofosine I 131, including EMA prime designation and FDA breakthrough therapy designation.
Pipeline development: Focused on advancing radiopharmaceutical pipeline, including iopofosine I 131, CLR 125, and CLR 225, to address cancers with significant unmet needs.
Regulatory hurdles: The FDA has requested 12-month follow-up data for iopofosine I 131, delaying the submission of the NDA under the accelerated approval pathway. Additionally, the approval process in the U.S. is contingent on the initiation of a confirmatory Phase III trial, which requires funding.
Financial constraints: The company’s cash and cash equivalents have decreased significantly, from $23.3 million at the end of 2024 to $12.6 million as of September 30, 2025. While recent financings have extended the runway to the third quarter of 2026, further funding is required to initiate critical trials and support operations.
Supply chain risks: The company relies on limited and rare isotopes like actinium-225 for its radiopharmaceuticals. Any disruption in the supply chain could impact the development and availability of CLR 225 and other products.
Market competition: The oncology market is highly competitive, and the company’s success depends on the timely approval and commercialization of its products. Delays or setbacks could allow competitors to capture market share.
Operational risks: The company is dependent on successful partnerships and collaborations to secure nondilutive capital and commercial expertise. Failure to establish or maintain these partnerships could hinder progress.
Clinical trial risks: The success of CLR 125 and CLR 225 depends on the outcomes of ongoing and planned clinical trials. Any negative results or delays in these trials could impact the company’s pipeline and strategic objectives.
Regulatory Strategy for Iopofosine I 131: Cellectar plans to file for conditional marketing approval in the EU for iopofosine I 131 based on the CLOVER-WaM study, with potential approval as early as 2027. The company also plans to submit an NDA under the accelerated approval pathway in the U.S. upon initiation of a confirmatory Phase III trial.
Partnerships for Iopofosine I 131: Cellectar is in active discussions with potential regional and global partners to accelerate the availability of iopofosine I 131 to patients, secure nondilutive capital, and leverage commercial expertise.
CLR 125 Phase Ib Study: The Phase Ib study of CLR 125 in relapsed triple-negative breast cancer will evaluate three dosing regimens and aims to determine the recommended Phase II dose. Initial dosimetry and efficacy data are expected throughout 2026.
CLR 225 Development: Pending financing, a Phase I trial for CLR 225 targeting pancreatic adenocarcinoma is planned. The trial will evaluate biodistribution, safety, and tolerability, with a focus on demonstrating proof of concept for treating large solid tumors.
Financial Position: Cellectar has raised $12.7 million in recent financings, extending its operational runway into the third quarter of 2026.
The selected topic was not discussed during the call.
The earnings call presents a mixed outlook. While there are positive developments such as decreased expenses and strong partnership momentum, significant risks persist, including reliance on rare isotopes and funding needs for trials. The Q&A reveals cautious optimism but lacks concrete guidance and pricing details, which may concern investors. Given the balanced nature of positive and negative factors, a neutral stock price reaction is expected.
While there are positive aspects, such as reduced R&D expenses and a strategic plan for accelerated approval, significant risks are present. Funding challenges and regulatory uncertainties are major concerns, as the company's plans hinge on securing additional capital. The Q&A reveals management's lack of clarity on critical timelines, further increasing uncertainty. The decrease in cash reserves and increased net loss also contribute to a negative outlook. Without a market cap, we assume mid-cap, leading to a likely stock price decrease of -2% to -8%.
The earnings call reveals multiple concerns: a significant decrease in cash reserves, ongoing regulatory and financial risks, and competitive market challenges. While cost reductions have improved net loss, the delay in NDA submission and reliance on strategic alternatives indicate uncertainty. The Q&A section highlights management's lack of clarity on critical trial decisions. Despite positive strides in cost management, the overall sentiment is negative, especially given the financial and operational risks. Without a market cap, the reaction is predicted as negative due to these uncertainties and challenges.
The earnings call highlights significant financial risks, including a steep decline in cash reserves, raising concerns about operational funding. The delay in NDA submission and regulatory uncertainties further contribute to a negative sentiment. Despite cost-cutting measures, the market competition and lack of clear strategic direction in the Q&A section suggest challenges ahead. These factors, combined with the absence of strong positive catalysts, imply a likely negative stock price reaction.
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