Release Date: November 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Plus Therapeutics Inc (PSTV, Financial) has made significant progress in its leptomeningeal metastases program, with the FDA agreeing to proceed under a multiple dose escalation protocol.
- The company reported favorable safety and tolerability results for doses of RNL up to 44 millicuries, with no dose-limiting toxicities observed.
- Plus Therapeutics Inc (PSTV) has secured substantial grant funding, including a $3 million award from the US Department of Defense and ongoing support from the NIH.
- The company is expanding its manufacturing capabilities, ensuring a reliable supply of RNL with a new GMP manufacturing partnership.
- Plus Therapeutics Inc (PSTV) is on track to commercially reintroduce its C Inside diagnostic test in early 2025, with plans for expanded market access and reimbursement.
Negative Points
- The cash and investment balance decreased to $4.8 million as of September 2024, down from $8.6 million in December 2023.
- The company reported a net loss of $9.1 million year-to-date 2024, indicating ongoing financial challenges.
- There is uncertainty regarding the timeline for obtaining necessary regulatory approvals and reimbursement codes for the C Inside diagnostic test.
- The therapeutic ratio for the RNL trials is still being evaluated, with potential safety concerns as the dose escalates.
- The company faces challenges in securing additional grant funding, with potential changes in government affecting future opportunities.
Q & A Highlights
Q: How do you view the opportunities for C Inside and RNL in LM as complementary products versus on their own?
A: Marc Hedrick, President and CEO, explained that the acquisition of C Inside was initially seen as a way to potentially increase the total addressable market for LM by improving diagnostic sensitivity. Over time, more data has shown that circulating tumor cells can be a proxy for survival and disease monitoring. The C Inside assay has shown high correlation with survival and progression, supporting its use as a secondary endpoint in trials.
Q: What does the landscape look like for grants, and do you anticipate any changes with the incoming government?
A: Marc Hedrick noted that while it's hard to predict changes at the federal level, being based in Texas provides some insulation. Plus Therapeutics has been successful with CPRIT, having nearly $18 million in active grants. They continue to explore additional opportunities and believe there is continued potential for grant funding.
Q: How did you determine the 13 millicurie dose for the LM multidose study, and how does it compare to doses in the compassionate use program?
A: Marc Hedrick stated that the 13 millicurie dose was derived from the cohort four dose in the single administration trial, which showed excellent safety and response. In the compassionate use program, patients received higher doses but at longer intervals, based on symptom recurrence.
Q: What is the timeline for obtaining CLIA compliance, CMS inspection, and Z code and PLA code for the C Inside assay?
A: Marc Hedrick indicated that they aim to commercialize the test in Q4 2024, with CLIA compliance and CMS inspection expected in Q1 2025. They are actively negotiating with institutions for reimbursement agreements and will provide more guidance once these are in place.
Q: Can you elaborate on the therapeutic ratio seen in your trials and the safety data profile?
A: Marc Hedrick highlighted that the therapeutic ratio in the LM trials is very high, with cohort four showing a ratio of about 50:1 and cohort five exceeding 100:1. This indicates a favorable safety profile, with minimal systemic absorption and high delivery to the target area.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
