PLUS THERAPEUTICS, INC. Q2 FY2023 earnings call

• Clinical and Regulatory Progress:
  • ReSPECT-LM: Completed Phase I Part A enrollment, FDA approved continuation to Part B dose escalation. Safety data showed low off-target radiation, no dose-limiting toxicities. Tumor cell counts trended lower post-treatment.
  • ReSPECT-GBM: Enrolling Phase I and II trials. Phase I has 4 patients in cohort 8, Phase II on track to complete enrollment by end 2024. Expanded clinical team and CROs.
  • Pediatric brain cancer: Responded to FDA request for additional safety data, anticipate IND approval in H2 2023.
  • BAM product: FDA notified it's regulated as a device, plan to finalize device designation and expand activities.
  • Supply Chain: Expanded supply agreements, contracted with Piramal for CGMP liposome intermediates.
• Financials:
  • Cash and cash equivalents $10.9M as of 6/30/2023.
  • Grant revenue $1.9M in Q2 2023.
  • Operating expenses $3.3M in Q2 2023, down from $5.1M prior year.
  • Net loss $1.5M in Q2 2023.

There are no distinct product segments with financial performance and revenue contribution stated. Instead, focus is on clinical program updates. For ReSPECT-LM trial: Completed Phase I Part A enrollment, safety data showed low off-target radiation, no dose-limiting toxicities, tumor cell counts trended lower post-treatment. For ReSPECT-GBM trial: Enrolling Phase I and II trials, with Phase I having 4 patients in cohort 8 and Phase II on track to complete enrollment by end 2024. Pediatric brain cancer trial: Anticipate IND approval in H2 2023. BAM product: Regulated as device, plan to finalize designation. Supply chain: Expanded agreements, contracted with Piramal for CGMP liposome intermediates.

• On track to initiate ReSPECT LM Phase I Part B in H2 2023.
• Publish ReSPECT GBM Phase I data and provide trial update at SNO meeting in Nov 2023.
• Anticipate IND approval for pediatric brain cancer trial in H2 2023.
• Finalize device designation for BAM product and expand activities.
• Progressing on portfolio and business development opportunities and nondilutive grant funding.

Q: Thoughts on approvable endpoints for LM beyond overall survival?

A: Marc Hedrick said at this point it's early, but beyond overall survival, quality of life, symptomatic improvement, and KOL metrics are considered as secondary endpoints.

Q: Reasons for LM underdiagnosis?

A: Marc Hedrick stated it's due to challenges in diagnostics (poor sensitivity/specificity of current methods) and lack of effective treatments, but tumor cell enumeration assay could help.

Q: Relationship between absorbed dose and tumor cell counts/survival in LM?

A: Marc Hedrick said it's not seen yet and will be explored in later cohorts.

Q: Repeat dosing for LM patients?

A: Marc Hedrick said likely incorporated into current trial protocol, pending FDA discussion.

Q: Regulatory pathway for BAM product?

A: Marc Hedrick said considering 510(k) and PMA pathways, with parallel evaluation ongoing.

Q: Grants beyond CPRIT?

A: Marc Hedrick said both CPRIT and NIH, taking a broad approach to secure funding through Phase II.