PSTV Shareholder/Stockholder Letter Transcript:
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PROXY STATEMENT
4200 Marathon Blvd. Suite 200,
Austin, TX 78756
(737) 255-7194
July 10, 2024
To Our Stockholders:
Last year Plus Therapeutics made significant progress in advancing our targeted radiotherapeutic platform and
strengthening our balance sheet. In 2024, we are poised to build on that progress and explore new opportunities
aimed at adding significant value to our pipeline.
Our lead investigational targeted radiotherapeutic drug, rhenium (Re186) obisbemeda is currently being evaluated
for use in patients with central nervous system cancers, specifically leptomeningeal metastases (LM) and
recurrent glioblastoma (rGBM).
Our LM therapy is being investigated in our ReSPECT-LM single administration dose escalation trial, expected to
complete Phase 1 enrollment as soon as this year. This trial continues to benefit from a 3-year, $17.6 million grant by
the Cancer Prevention & Research Institute of Texas awarded in 2022, and an FDA Fast Track designation for use in
patients with breast cancer. Interim ReSPECT-LM data was presented at the 2023 Society for Neuro-Oncology Annual
Meeting and showed safety, feasibility, and signs of tumor response in early cohorts. Our next steps include evaluating
and presenting final Phase 1 data, initiating a Phase 1 multi-dose clinical trial, and potentially starting a Phase 2/3
single-dose registrational trial pending final data read out and agreement with the FDA.
In 2023, we licensed a novel diagnostic and disease monitoring assay (CNSide ) for LM that offers clear and
important advantages compared to existing diagnostic methodologies. As LM is two-to-four times underdiagnosed, this
assay may substantially increase the total addressable market for our LM therapy. Subsequently in 2024, we obtained
all rights for the assay, and plan to commercialize and eventually partner the asset. Several peer-reviewed studies
supporting the utility of this assay have been published or are in press, and the FORESEE clinical trial data will be
presented on August 8-10 at the 2024 SNO/ASCO CNS Metastases Conference.
Our rGBM therapy is currently being investigated in the Phase 2 ReSPECT-GBM trial, funded in part by the
U.S. National Institutes of Health. Interim data from the trial were presented at the 2023 Society for Neuro-Oncology
Annual Meeting and showed continued safety, feasibility, and an efficacy signal favorable to the standard of care.
The Phase 2 trial continues to treat patients and add new sites with the goal of completing enrollment in the next few
quarters. The Company will present the data and proceed to a Phase 3 pivotal trial thereafter.
We also plan to obtain an FDA Investigational New Drug ( IND ) approval to evaluate rhenium (Re186)
obisbemeda in patients with pediatric brain cancer (PBC), specifically ependymoma and high-grade glioma, as
part of the ReSPECT-PBC Phase 1 clinical trial. This trial recently received a $3 million award to support the
trial by the U.S. Department of Defense.
In 2023, we strengthened and expanded our supply chain to enable registrational clinical trials and commercial
readiness. In 2024, we raised sufficient capital, which, combined with existing grant funding, allows the company
to achieve its plans through 2026.
We are off to a great start in 2024 and the future is bright for Plus Therapeutics! On behalf of our employees
and board of directors, I would like to express our appreciation for our stockholders and partners for their help
and support in 2023 and beyond.
Sincerely,
Marc H. Hedrick
President & Chief Executive Officer
7/10/2024 Letter Continued (Full PDF)