• Cash and Investments Balance: $3.6 million as of December 31, 2024, compared to $8.6 million at December 31, 2023.
• Grant Revenue: $5.8 million in 2024, up from $4.9 million in 2023.
• Operating Loss: $14.7 million in 2024, compared to $13.3 million in 2023.
• Net Loss: $13 million or $0.95 per share in 2024, compared to $13.3 million or $4.24 per share in 2023.
• Equity Financing: $15 million in gross proceeds from an underwritten equity financing in early March 2025.
• Grant Funding for 2025: Expected to be in the range of $6 to $8 million.
• Additional Grant Proceeds: $7.2 million remaining to be received from grants, with $2 million received in Q1 2025.
• Department of Defense Grant: Over $2 million remaining from a $3 million award for the Respect pediatric brain cancer trial.

• Warning! GuruFocus has detected 1 Warning Sign with PSTV.

Release Date: March 27, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Plus Therapeutics Inc (NASDAQ:PSTV) successfully completed an underwritten equity financing of $15 million, strengthening its balance sheet and funding key milestones into mid-2026.
• The company received FDA orphan designation for its lead drug, Robic, for use in patients with leptomeningeal metastasis (LM) due to lung cancer, adding to previous designations for breast cancer.
• Plus Therapeutics Inc (NASDAQ:PSTV) has expanded its senior leadership team with experienced professionals in oncology and diagnostics, enhancing its clinical and commercial capabilities.
• The company reported promising clinical data for its lead drug, Robic, in phase one trials, showing a median overall survival of 9 months for LM patients, compared to the historical 4 months.
• Plus Therapeutics Inc (NASDAQ:PSTV) is on track to launch its CNI tumor cell enumeration test commercially in 2025, which could significantly increase the total addressable market for Robic.

Negative Points

• The company's cash and investments balance decreased from $8.6 million at the end of 2023 to $3.6 million at the end of 2024, indicating a need for careful financial management.
• Plus Therapeutics Inc (NASDAQ:PSTV) reported an operating loss of $14.7 million in 2024, up from $13.3 million in 2023, primarily due to increased spending on clinical trials.
• The net loss for 2024 was $13 million, which, although slightly lower than 2023, still reflects significant financial challenges.
• The company faces uncertainties related to FDA approval processes and the need for further clinical trials to validate its drug's efficacy and safety.
• Plus Therapeutics Inc (NASDAQ:PSTV) must navigate complex market access activities, including state licensures and payer agreements, to successfully commercialize its CNI test.

Q & A Highlights

Q: On the CN insight, do you anticipate building up a major sales force or will you look for partners to commercialize this? A: Marc Hedrick, President and CEO: We do not plan to build a major sales force. This is a niche opportunity, and we are starting with academic neuro-oncologists at major oncology centers. There are about 300 neuro-oncologists in the country, and our initial focus will be on this narrow group of thought leaders and major institutions. Over time, we may expand to the broader medical oncology market. Partnering in the US or outside is something we will consider in the future.

Q: The recurrent GBM trial is the most advanced. What must happen to meet the goal of data this year? A: Marc Hedrick, President and CEO: Although superficially GBM is in late-stage phase two, LM could get approved before. We've enrolled over 50 patients, completed phase one, and are over halfway through phase two. The key is adding new sites, and we now have five sites enrolling. We are focused on completing the enrollment of 11 more patients this year.

Q: Can you remind me of the powering assumptions behind the GBM trial? A: Marc Hedrick, President and CEO: The phase two trial's comparator is the standard of care. We've conducted real-world control arms, and patients treated with monotherapy live under 8 months. The trial is powered at 80% with a comparator of about 8 months median overall survival. The trial size is around 100 to 150 patients, and discussions with the FDA about using real-world control data could reduce the number of active patients needed.

Q: On the LM study, you proposed a dose expansion at the 44 milli dose. Is that an additional cohort to the phase one study or part of the phase two study? A: Marc Hedrick, President and CEO: Ideally, the FDA would sign off on a phase 2 trial focused on breast cancer, with 15 patients each for HER2 positive and negative at the 44 milli dose. The phase one dose is a basket trial including various cancer patients. The goal is to sort out patient segmentation by molecular subtype and align with the FDA on endpoints, potentially leading to a phase 2 or phase 23 pivotal design.

Q: Regarding the multi-dose study, would you wait for the first data to come out before initiating a phase two, or would you build that into a phase two? A: Marc Hedrick, President and CEO: We plan to move directly into a phase two or phase 1B. The multi-dose data will be important for performance data and trial design. The phase one data is promising, with long tail survival observed. We aim to pursue a single dose approval quickly, with dose optimization layered on as data becomes available.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.