Aug 13, 2026 earnings call — iopofosine progress and Phase III initiation
Initiated site activation for confirmatory Phase III and expects to submit a new drug application in mid-2027 under the FDA's accelerated approval program.
EPS $-0.57 (est $-0.52)
Key quotes
"Once necessary site activation and ongoing patient enrollment is achieved, we expect to be in a position to submit our new drug application under the FDA's accelerated approval program in mid-2027."
"These results demonstrated a 79.2% major response rate, an 87.5% overall response rate, and 100% clinical benefit rate, and encouraging durability with a median duration of response of 16 months."
"The company received $35 million gross upfront, or approximately $31.7 million net, for common shares and prefunded warrants."
Analyst Q&A 2
Phase III start timing and FDA submission criteria
Q (Kevin DeGeeter · Ladenburg): He asked what steps still limit first patient enrollment and whether FDA needs a specific number of patients to accept a submission. He also asked when CLR 125 dosimetry data might be shared.
A: Management listed many start-up steps: CRO contracting, site identification, feasibility, radiopharmaceutical qualification, IRB review, site contracting, training, and site initiation. They said first sites could open in the coming months with a potential first patient late this year or early next year, they still view March-April as the submission timing, and their interpretation is to have perhaps 10 to 20 sites open and a couple patients enrolled at submission and 5% or more patients enrolled by regulatory action 6 to 8 months later. On CLR 125 they said they expect some data later this year, possibly at the San Antonio Breast Cancer Conference, that tumor uptake looks good and they are optimizing dose in a Phase Ib.
"Our interpretation of that is that we want to have a number of sites open somewhere -- perhaps 10 to 20 sites open at the time of submission." — Jarrod Longcor (COO)
manufacturing, launch timing, and actinium supply
Q (Brian Kemp Dolliver · Brookline): He asked whether they are manufacturing any commercial supply now, how quickly they could launch after accelerated approval, and how actinium-225 availability compares to a year ago.
A: They said they produce the targeting ligand at commercial scale now with more than 5 years stability, but cannot make the isotope or finished product until near-term just-in-time production; their commercial infrastructure is built and can be turned on quickly after approval. They said finished-product capacity would support about 100 patients per week, but full commercial "lock and load" typically takes a 12-month period at a minimum and speed depends on investment and partner choices. On actinium-225 they said supply has opened up versus a year ago with new suppliers coming online and they have ready supply agreements with 4 parties.
"So it's typically a 12-month period at a minimum to fully lock and load for commercial execution." — James Caruso (CEO)