PLUS THERAPEUTICS, INC. Q3 FY2023 earnings call

• Clinical and regulatory progress: ReSPECT-GBM trial enrollment challenges with efforts to add sites by end-2024, Phase I dose escalation ongoing; ReSPECT-LM Phase I/IIa trial saw Cohort 4 completion post-FDA Type C meeting, Part A of Phase I completed with favorable safety profile; pediatric trial travel initiation delayed but positive follow-up meeting in Q3 with plans to initiate Phase I in early 2024; BAM radioembolic product regulated as a device by CDRH with reduced clinical requirements and timeline.
• Grant funding: Received $1.9 million advanced payment from CPRIT in September, expects additional CPRIT grants up to $10.2 million by Dec 31, 2024, and NIH grant fully utilized by end-2024 to coincide with Phase II trial completion.

As of September 30, 2023, cash and cash equivalents were $11 million, consistent with the balance at June 30, 2023. The company recognized $1.2 million of grant revenue in the third quarter of 2023 and $3.6 million year-to-date 2023. It forecasts grant revenue of between $1 million to $1.5 million in Q4 2023 and between $6 million to $7 million for calendar year 2024. Total operating expenses for the third quarter of 2023 decreased by $0.7 million to $4.5 million, compared to $5.2 million in the prior-year period. Net loss for the third quarter of 2023 was $3.2 million or $1 per share, compared to a net loss of $5.2 million or $2.85 per share in the prior-year period.

• Q4 2023: Multiple presentations at SNO Annual Meeting, including first data cut from ongoing Phase II GBM trial and update on LM trial.
• 2024: Complete enrollment in Phase II ReSPECT-GBM trial and finalize pivotal trial design with FDA; complete enrollment in Phase I ReSPECT-LM trial and begin Phase II; complete internal implementation of CNSide assay; obtain FDA IND approval and initiate Phase I ReSPECT pediatric brain cancer trial; complete key development milestones for 188RNL-BAM; publish ReSPECT-GBM Phase I data in peer-reviewed publication.

• Biocept bankruptcy: Plus transferred CNSide assay technology but retains uncertainty regarding exclusivity option exercise.
• FDA regulation: Uncertainty around pediatric dosimetry and radiation treatment requirements for trial approvals.
• Supply chain: Risks related to isotope availability and ensuring across-the-board supply chain redundancy.

Q: Justin Walsh asked about what to expect from presentations at SNO and details of previous data.

A: Marc Hedrick said last time 34 patients were treated in the GBM trial, 5 abstracts accepted with updated imaging data to be presented.

Q: Sean Lee asked about FDA requests for pediatric study.

A: Norman LaFrance explained FDA reviewed adult dosimetry and safety data, with plans to finish minor clarifications with FDA this quarter and start pediatric trial early 2024.

Q: Edward Woo asked about Cohort 4 of the LM trial.

A: Norman LaFrance said enrollment rate expected to continue, Cohort 6 likely to complete full dose escalation by June 2024 and prepare for Phase II discussion with FDA.

Q: Chad asked about implementation of CNSide in the LM study after Biocept bankruptcy.

A: Marc Hedrick said Plus transferred technology and retains exclusivity option to use the assay in the trial for research purposes.