PLUS THERAPEUTICS, INC. ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2024
Plus Therapeutics, Inc. filed its Annual Report on Form 10-K for the year ended December 31, 2024. The company reported total revenues of $X, a decrease of Y% compared to the prior year. Net loss for the year was $Z, with a basic and diluted loss per share of $W. As of December 31, 2024, the company had cash and cash equivalents of $X, and total assets of $Y. The company’s stock was listed on the Nasdaq Capital Market under the ticker symbol PSTV, and as of March 21, 2025, there were 16,999,626 shares of common stock issued and outstanding. The company’s market value was $8.2 million as of June 28, 2024.
Overview of the Company’s Financial Performance
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing innovative treatments for cancer. The company’s key product candidate is REYOBIQ™, a novel injectable radiotherapy designed to deliver targeted, high-dose radiation directly into glioblastoma (GBM) tumors.
In 2024, Plus Therapeutics reported a net loss of $13.0 million, compared to a net loss of $12.9 million in 2023. The company’s research and development expenses increased by $0.9 million in 2024, primarily due to increased costs for the ongoing ReSPECT-LM clinical trial for REYOBIQ™ in leptomeningeal metastases (LM). General and administrative expenses also increased by $1.4 million in 2024, mainly due to higher legal and professional fees.
Revenue and Profit Trends
Plus Therapeutics’ primary source of revenue in 2024 and 2023 was grant funding. In 2022, the company entered into a $17.6 million grant contract with the Cancer Prevention and Research Institute of Texas (CPRIT) to support the development of REYOBIQ™ for LM. The company recognized $5.8 million, $4.9 million, and $0.2 million in grant revenue in 2024, 2023, and 2022, respectively.
The company has not yet generated any revenue from the commercial sale of its product candidates, as they are still in clinical development. Plus Therapeutics’ net losses in 2024 and 2023 reflect the ongoing costs of research and development, as well as general and administrative expenses required to support the company’s operations.
Analysis of Strengths and Weaknesses
Strengths:
- Promising clinical data for REYOBIQ™ in GBM and LM, with the potential to significantly improve patient outcomes
- Orphan drug designations and Fast Track status from the FDA for REYOBIQ™ in GBM and LM, which may expedite the regulatory approval process
- Secured significant grant funding from CPRIT and the Department of Defense to support the continued development of REYOBIQ™
- Established partnerships and collaborations to expand the company’s pipeline and capabilities, such as the agreement with K2bio for novel biomarker analysis
Weaknesses:
- Recurring net losses and negative cash flows from operations, which raise substantial doubt about the company’s ability to continue as a going concern
- Reliance on external financing, such as equity offerings and debt, to fund ongoing operations and development activities
- Limited commercial experience, as the company’s product candidates are still in clinical trials and have not yet been approved for sale
- Potential challenges in manufacturing and scaling up production of REYOBIQ™ as the company advances its clinical programs
Outlook for the Future
The future outlook for Plus Therapeutics is closely tied to the continued development and potential regulatory approval of REYOBIQ™. The company is currently enrolling patients in the Phase 2 ReSPECT-GBM trial for REYOBIQ™ in recurrent GBM, with a target for full enrollment by the end of 2025. Additionally, the company has initiated the ReSPECT-LM Phase 1 trial for REYOBIQ™ in LM and plans to begin enrollment for a ReSPECT-LM Multi-Dose trial in the first half of 2025.
The company has also announced plans to expand its clinical pipeline to include the treatment of pediatric brain cancers, such as high-grade glioma and ependymoma, through the ReSPECT-PBC trial, which is expected to begin enrollment in 2025.
However, the company’s ability to continue its operations and advance its clinical programs is heavily dependent on its ability to raise additional capital. As of December 31, 2024, Plus Therapeutics had $3.6 million in combined cash and short-term investments, which may not be sufficient to fund its planned activities for the next 12 months. The company has explored various financing options, including equity offerings, debt financing, and potential collaborations or licensing agreements, but there can be no assurance that it will be able to secure the necessary funding to continue its operations.
Additionally, the company’s recent delisting notice from Nasdaq and the subsequent actions taken to regain compliance with the minimum stockholders’ equity requirement highlight the financial challenges the company is facing. While the company was able to regain compliance through the March 2025 private placement, it will be subject to a mandatory panel monitor until March 2026, which could limit its flexibility and access to capital markets.
Overall, the future success of Plus Therapeutics will depend on its ability to successfully advance REYOBIQ™ and its other pipeline candidates through clinical trials, secure regulatory approvals, and ultimately, generate revenue from the commercialization of its products. However, the company’s ongoing financial constraints and the need for continued external financing pose significant risks and uncertainties that could impact its long-term viability.
