Release Date: August 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) presented significant clinical progress at the 2024 Society for Neuro-Oncology and combined American Society for Clinical Oncology CNS Metastases Conference.
- The ReSPECT-LM trial showed promising safety and efficacy data, with no dose-limiting toxicities and a median overall survival of 12 months, which is encouraging compared to the typical survival rates of two to six months for leptomeningeal metastases (LM).
- The CNSide diagnostic tool demonstrated high sensitivity and specificity, influencing treatment decisions in over 90% of clinical cases and identifying actionable mutations in 24% of therapeutic selections.
- The company received substantial non-dilutive funding, including an $18 million product development award from CPRIT and a $3 million award from the US Department of Defense for pediatric brain cancer trials.
- Plus Therapeutics Inc (PSTV) is expanding its clinical trial sites and capabilities, with new sites expected to enroll patients soon, enhancing the potential for faster trial completion and broader data collection.
Negative Points
- The cash and investments balance decreased slightly to $8.4 million as of June 30, 2024, compared to $8.6 million at the end of 2023.
- Total operating loss for the first half of 2024 increased to $7 million from $6.2 million in the same period of 2023, primarily due to increased spending on the ReSPECT-LM trial.
- The company faces uncertainties and risks related to the approval and implementation of new trial protocols, which could impact the timeline and success of ongoing studies.
- Enrollment for the ReSPECT-GBM trial may extend into the first half of 2025, potentially delaying the completion and subsequent data analysis.
- The company is still in the process of scaling up its CNSide diagnostic capabilities and obtaining CLIA certification, which could delay the commercial availability of the test.
Q & A Highlights
Q: Can you provide more context around the types of treatment decisions informed by CNSide? Therapy selection is one, but the 24% that informed therapy selection is lower than the 90% total decisions impacted.
A: One key decision is determining if the patient has the disease, which is crucial for deciding if treatment is necessary. The test's high sensitivity helps in making this determination. Another decision involves assessing genetic drift, which can influence the choice of drugs. Additionally, the test can help decide if treatment should be stopped based on circulating tumor cell counts. Overall, there are at least three solid ways the test impacts clinical decision-making. (Marc Hedrick, CEO)
Q: Do you have any expectations regarding the timing for the multi-dose LM portion of the trial?
A: The IND is open, and we are optimistic about the FDA's feedback. We are already preparing sites for the trial, which should start later this year. Enrollment should be quicker than the single-dose trial due to fewer regulatory hurdles and the involvement of multiple sites. We will provide more detailed timing once we have final feedback from the FDA. (Marc Hedrick, CEO)
Q: What are the next steps before you can start selling the CNSide test to the market?
A: We have acquired all necessary IP, assets, and customer information. The test is up and running in our trials, and we are manufacturing the required microfluidic chips. We are scaling the test to accommodate increased testing needs for our multiple-dose trial. We are also conducting a commercial evaluation to determine the market opportunity and required investment. (Marc Hedrick, CEO)
Q: Does it still make sense to continue the single-dose LM study now that you have a multi-dose study in the works?
A: The FDA is interested in determining the maximum tolerated dose, so we will continue the single-dose study until we reach that point. However, we believe multiple doses will be necessary for long-term treatment. We will decide whether to take the single-administration dose into a pivotal trial or wait for multiple-dose data based on ongoing results and discussions with the FDA. (Marc Hedrick, CEO)
Q: Can we expect any more data updates from the GBM study later this year?
A: We will provide a meaningful update on the Phase 1 and Phase 2 progress at the Congress for Neurosurgeons in late September and early October. We aim to complete enrollment by the end of the year, but it may extend into the first half of next year. Based on continued positive safety and efficacy signals, we are prepared to move forward with a pivotal trial design. (Marc Hedrick, CEO)
Q: Is there any seasonality to grant funding, and have you noticed any changes in the availability of funding?
A: Grant funding can be seasonal, particularly with organizations like CPRIT, which has specific times of the year for accepting grants. The NIH and DoD grants can be more sporadic. We have developed a good relationship with CPRIT and continue to seek non-dilutive capital to minimize shareholder dilution. (Marc Hedrick, CEO)
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
