Cellectar Biosciences (CLRB) Q4 2024 earnings summary

Executive summary

• Achieved regulatory clarity and FDA alignment for iopofosine I 131 in relapsed/refractory Waldenstrom macroglobulinemia (WM), with a confirmatory Phase III study design finalized and a clear path for accelerated and full approval.

• Strong clinical results from the CLOVER-WaM study: 98.2% clinical benefit rate, 83.6% overall response rate, and 58.2% major response rate, exceeding FDA-agreed endpoints in a difficult-to-treat population.

• Advanced pipeline with IND clearance for Auger-emitting radioconjugate and plans for IND submission for alpha-emitting radioconjugate, targeting solid tumors.

• Advanced discussions and evaluation of non-dilutive licensing and collaboration deals to fund pivotal studies and commercialization.

Financial highlights

• Ended 2024 with $23.3 million in cash and equivalents, up from $9.6 million at the end of 2023, supported by warrant exercises and inducement financing.

• Executed warrant exercises and inducement financing, raising $44.1 million in January and $19.4 million in July.

• Full-year 2024 net loss was $44.6 million ($1.22 per basic share), compared to $42.8 million ($3.50 per share) in 2023.

• Research and development expenses were $26.1 million, down from $27.3 million in 2023; SG&A expenses rose to $25.6 million from $11.7 million, driven by pre-commercialization activities.

• Other income (net) was $7.4 million, mainly non-cash, versus a $3.9 million expense in 2023.

Outlook and guidance

• Cash runway extends into Q4 2025, including costs for IND filings and initiation of Phase I studies for CLR 121225 and CLR 121125.

• Phase III iopofosine study to enroll 200 patients (100 per arm), with full enrollment expected within 24 months of first patient dosed.

• Estimated cost for the Phase III study is $40–$45 million, with $30 million needed for full enrollment and NDA submission.

• Phase I studies for CLR 121225 (pancreatic cancer) and CLR 121125 (triple-negative breast cancer) to begin in first half of 2025, each costing ~$4.5 million.