Radiopharm Faces Funding Pressure Despite Clinical Progress and New Appointments
Radiopharm Theranostics has secured FDA approval to initiate a Phase I trial targeting B7H3 and raised A$40 million to accelerate its radiopharmaceutical programs. The company also appointed renowned oncologist Dr Oliver Sartor to its Scientific Advisory Board.
- FDA IND approval for Phase I Betabart (RV-01) therapeutic trial targeting B7H3
- Positive clinical progress across four radiopharmaceutical programs
- A$35 million institutional placement plus A$5 million Share Purchase Plan completed
- Appointment of Dr Oliver Sartor to Scientific Advisory Board
- Cash balance of A$19 million with runway extended into 2027
Clinical Pipeline Momentum
Radiopharm Theranostics (ASX, RAD) has reported significant progress in its clinical development programs during the quarter ended 30 September 2025. The company received Investigational New Drug (IND) approval from the US Food and Drug Administration to commence a Phase I therapeutic trial of Betabart (RV-01), a novel radiopharmaceutical targeting the B7H3 immune checkpoint protein. This milestone marks a key step in advancing a first-in-class therapy designed to selectively attack solid tumours with potentially fewer side effects.
Alongside this, Radiopharm provided encouraging updates on four other clinical programs. The RAD 101 Phase 2b imaging study targeting brain metastases continues to demonstrate strong tumour uptake, reinforcing earlier proof-of-concept data. The RAD 202 and RAD 204 Phase 1 trials, focusing on HER2-positive and PD-L1-positive solid tumours respectively, have shown promising safety profiles and tumour targeting, with dose escalations underway. Meanwhile, RAD 301, an imaging agent for pancreatic cancer, is progressing towards Phase 2 evaluation based on positive early results.
Strategic Appointments and Capital Raising
In a move to bolster its scientific leadership, Radiopharm appointed Dr Oliver Sartor, a globally recognised oncologist specialising in radiopharmaceutical therapies, to its Scientific Advisory Board. Dr Sartor’s extensive experience in prostate cancer and radioligand therapy is expected to provide valuable guidance as Radiopharm advances its pipeline.
Financially, the company strengthened its position with a A$35 million institutional placement and a subsequent A$5 million Share Purchase Plan, supported notably by strategic investor Lantheus Holdings. These funds, combined with an existing cash balance of A$19 million, extend Radiopharm’s operational runway into 2027, enabling continued investment in clinical trials, manufacturing, and corporate activities.
Operational and Financial Overview
During the quarter, Radiopharm’s net cash outflows from operating activities were A$9.29 million, primarily driven by research and development and staff costs. The company also received a research and development tax refund of approximately A$4.5 million, reflecting ongoing government support for innovation. Payments to related parties, including director fees, were disclosed in line with ASX requirements, underscoring transparent governance practices.
Looking ahead, Radiopharm has outlined key clinical milestones expected through 2026, including topline data releases and potential Phase 3 trial initiations. The company’s diversified pipeline and strengthened capital base position it well to navigate the complex path of radiopharmaceutical development.
Bottom Line?
Radiopharm’s clinical advances and fresh capital set the stage for pivotal data releases that could reshape its growth trajectory.
Questions in the middle?
- Will upcoming Phase 2 and Phase 3 data confirm the early promise shown by Radiopharm’s imaging and therapeutic candidates?
- How will Dr Oliver Sartor’s expertise influence Radiopharm’s strategic direction and clinical trial design?
- What impact will Lantheus Holdings’ increased stake have on Radiopharm’s partnerships and market positioning?
