Release Date: May 15, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Plus Therapeutics Inc (PSTV, Financial) successfully closed a private placement financing, raising $19.25 million to fund ongoing projects.
- The company received a $3 million grant from the US Department of Defense to support a Phase 1/2 trial for pediatric brain cancer, highlighting strong external support and validation of their research.
- Plus Therapeutics Inc (PSTV) has made significant clinical progress, particularly with the enrollment and dosing in their rhenium (186Re) obisbemeda trials for leptomeningeal metastases.
- The company has expanded its clinical trial sites, which is expected to accelerate patient enrollment and trial completion, setting a strong foundation for future pivotal trials.
- Plus Therapeutics Inc (PSTV) has strategically acquired the CNSide diagnostic platform, enhancing its diagnostic capabilities and potentially opening up new commercial opportunities.
Negative Points
- Despite the recent financing, Plus Therapeutics Inc (PSTV) reported a decrease in cash balance from $8.6 million at the end of the previous quarter to $3 million.
- The company is still in the early stages of discussion with the FDA regarding the multi-dose expansion arm for their Phase 1 trial, indicating potential delays in trial progression.
- There are ongoing needs to expand the manufacturing and supply chain capabilities to meet future demands, which could pose challenges if not managed effectively.
- The reliance on grant funding and financing to support trials and operations could pose risks if additional funding is not secured timely.
- While the company has made progress in clinical trials, the actual commercial viability and regulatory approval of their therapies are still uncertain and pending detailed efficacy and safety data.
Q & A Highlights
Q: What are your current thoughts on the overall development timeline for rhenium obisbemeda in GBM versus LM?
A: Marc Hedrick, President and CEO, explained that LM development might lead to an approved product before GBM due to no existing approved products for LM and potential FDA acceptance of a Phase 2/3 pivotal trial. He outlined a possible aggressive timeline for a pivotal trial in LM, suggesting quicker progress compared to GBM.
Q: Can you provide any expectations on the additional patients' worth of data we can expect at upcoming conferences?
A: Marc Hedrick mentioned that for GBM, they are looking to add a couple more patients in Cohort 8, aiming to complete enrollment this year with the help of three additional sites. For LM, they have dosed the first three patients in Cohort 5, with potential to complete all cohorts depending on safety outcomes.
Q: What are the key clinical questions for Rhenium Obisbemeda at this point?
A: Marc Hedrick discussed that the key issues vary by indication. For solid tumors in the CNS, the focus is on optimizing delivery and absorbed dose. For CSF-related treatments, the main question is determining the optimal dosing profile and frequency to effectively treat patients.
Q: Regarding the $3 million grant from the US Department of Defense for pediatric brain cancer, is there potential for additional funding beyond Phase 1?
A: Norman LaFrance, Chief Medical Officer, confirmed potential for additional funding to accelerate the Phase 1 trial and possibly extend into Phase 2, reflecting optimism based on adult data and discussions with pediatric specialists.
Q: What differences can we expect in the data presented at the SNMMI Nuclear Medicine meeting versus the SNO/ASCO meeting?
A: Marc Hedrick clarified that the SNMMI presentation would largely recapitulate previously presented data to reach different medical audiences. The SNO/ASCO meeting will update on enrollment and safety but will not delve into efficacy or cell count data, which is reserved for a more comprehensive update at the SNO annual meeting in November.
Q: Have you decided on the dosing regimen for the pediatric study?
A: Norman LaFrance indicated that the dosing protocol, similar to the LM study, has been essentially approved by the FDA. The pediatric study will start with smaller tumors and escalate in volume and administered dose, with a strong collaborative framework with neuro oncologists and surgeons at Lurie.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
