Business Overview

Plus Therapeutics, Inc. (NASDAQ:PSTV) is a U.S. pharmaceutical company developing innovative targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers. The company's novel radioactive drug formulations and therapeutic candidates are designed to deliver safe and effective doses of radiation directly to tumors, minimizing exposure to healthy tissues.

Plus Therapeutics' lead radiotherapeutic candidate, rhenium (186Re) obisbemeda, is specifically designed for CNS cancers including recurrent glioblastoma (GBM), leptomeningeal metastases (LM), and pediatric brain cancers (PBC). The company's acquired radiotherapeutic candidate, Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere ("188RNL-BAM"), is designed to treat solid organ cancers including primary and secondary liver cancers.

The company's headquarters and manufacturing facilities are located in Texas, in proximity to world-class cancer institutions and researchers. Plus Therapeutics has built a robust supply chain through strategic partnerships that enable the development, manufacturing and potential future commercialization of its products.

Financials

For the full year 2023, Plus Therapeutics reported annual revenue of $4.9 million and a net loss of $13.3 million. The company's annual operating cash flow was -$12.9 million, and its annual free cash flow was -$13.0 million.

In the first quarter of 2024, the company recognized $1.7 million in grant revenue, compared to $0.5 million in the same period of the prior year. The total operating loss for Q1 2024 was $3.3 million, down from $4.8 million in Q1 2023. Net loss for Q1 2024 was $0.75 per share, compared to $2.07 per share in the same quarter of the previous year.

Liquidity

As of March 31, 2024, Plus Therapeutics had a cash balance of $3 million. However, the company has access to additional sources of funding, including a recently closed private placement financing of up to $19.25 million and continued grant funding.

Specifically, the company is on track to receive $6.9 million in grant advances from the Cancer Prevention and Research Institute of Texas (CPRIT) in 2024, as well as $1 million from a $3 million grant awarded by the U.S. Department of Defense. Additionally, the company continues to benefit from a National Institutes of Health (NIH) grant that covers approximately 90% of the costs for the ReSPECT-GBM Phase I/II trial.

Clinical Pipeline and Upcoming Milestones

Plus Therapeutics' most advanced investigational drug, rhenium (186Re) obisbemeda, is currently being evaluated in several clinical trials:

ReSPECT-LM Phase I Dose Escalation Trial for Leptomeningeal Metastases (LM)

The ReSPECT-LM trial is substantially funded by the CPRIT grant. During Q1 2024, the company announced the enrollment of the 3 required patients for dosing in Cohort 5, at a single radiation dose of 66.1 millicuries. As of the most recent data update in March 2024, 12 of 18 patients dosed remained alive. The company expects to present updated enrollment and safety data at the SNO/ASCO meeting in August 2024.

ReSPECT-GBM Trial for Recurrent Glioblastoma (GBM)

Plus Therapeutics continues to enroll both Phase II patients with GBM tumors less than or equal to 20 milliliters and Phase I patients with GBM tumors greater than 20 milliliters. The company has added three new clinical sites in the Midwest, New York, and Florida to help accelerate enrollment and set the stage for a future pivotal trial. The company plans to provide a comprehensive update on the Phase II data at a key neurosurgery or neuro-oncology meeting later this year.

ReSPECT-PBC Trial for Pediatric Brain Cancers

With the support of a $3 million grant from the U.S. Department of Defense, Plus Therapeutics plans to initiate a Phase I trial evaluating rhenium (186Re) obisbemeda in children with high-grade glioma and ependymoma. The company anticipates obtaining IND approval from the FDA in 2024 and beginning enrollment at the initial site, Lurie Children's Hospital in Chicago, in early 2025.

Acquisition of CNSide Diagnostic Platform

In Q1 2024, Plus Therapeutics exclusively acquired the CNSide diagnostic platform, which includes three types of tests: cancer cell enumeration, FISH testing for cancer-specific gene expression, and next-generation sequencing of cell-free DNA. The company plans to commercially launch the CNSide tests as early as Q4 2024, targeting a total addressable market of over 0.5 million tests annually.

Outlook

For the full year 2024, Plus Therapeutics expects grant revenue to be in the range of $6 million to $7 million. The company also plans to:

- Present updates on the ReSPECT-LM and ReSPECT-GBM trials at key medical conferences throughout 2024 - Obtain FDA feedback on a multi-dose Phase I trial for ReSPECT-LM and the ReSPECT-PBC IND application - Complete enrollment in the ReSPECT-LM Phase I dose escalation trial and determine the maximum tolerated and recommended Phase II doses - Contract with a second GMP manufacturing supplier to support rhenium (186Re) obisbemeda supply for pivotal trials and commercialization - File at least $10 million in new grant applications in 2024

Risks and Challenges

While Plus Therapeutics has made significant progress in advancing its targeted radiotherapeutic pipeline, the company faces several risks, including the inherent uncertainties of clinical development, regulatory approvals, and commercialization. Additionally, the company's ability to continue as a going concern is dependent on its ability to obtain additional financing.

Conclusion

Overall, Plus Therapeutics' innovative approach to targeted radiotherapy for CNS cancers, its robust clinical pipeline, and the potential of its newly acquired CNSide diagnostic platform position the company as a promising player in the oncology space. Investors should closely monitor the company's upcoming milestones and data readouts to assess the progress and potential of its unique therapeutic solutions.