AUSTIN, Texas - Plus Therapeutics, Inc. (NASDAQ:PSTV) has announced updated results from its ongoing ReSPECT-GBM Phase 1/2 clinical trial, focusing on the treatment of recurrent glioblastoma, a form of brain cancer. The data, presented at the Congress of Neurological Surgeons Annual Meeting on September 30, 2024, in Houston, Texas, shows that the company's lead asset, Rhenium (186Re) Obisbemeda, continues to demonstrate a favorable safety profile and potential efficacy in patients.
The ReSPECT-GBM trial is investigating the feasibility and safety of Rhenium (186Re) Obisbemeda, delivered through convection enhanced delivery (CED), and aims to determine the maximum tolerated dose and potential efficacy in adult patients with recurrent glioma. To date, 42 patients have enrolled across three sites, with 19 treated at the recommended Phase 2 dose.
Key findings include an average absorbed radiation dose to the tumor of 300 Gy, with 89% of patients receiving a dose exceeding 100 Gy, which is considered a minimal dose threshold. Most adverse events reported were mild or moderate, and only one dose-limiting toxicity was observed.
The trial has now expanded to two additional leading U.S. academic medical centers, increasing its reach and potentially accelerating the completion of both Phase 1 and Phase 2 arms of the study. The trial's extension to new sites, such as North Shore University in New York and Ohio State University in the Upper Midwest, is expected to support the further development of Rhenium (186Re) Obisbemeda as a treatment option.
Glioblastoma affects approximately 15,000 patients annually in the U.S., with a survival rate of around 5% after five years. Current treatments offer limited survival benefits and are associated with significant side effects. Rhenium (186Re) Obisbemeda aims to deliver targeted high-dose radiation to CNS tumors, potentially improving patient outcomes.
The ReSPECT-GBM trial is actively enrolling patients, and those interested can find additional information through the trial's dedicated channels. This press release statement serves as the source of the information reported.
In other recent news, Plus Therapeutics, a clinical-stage pharmaceutical company, has made significant strides in its Phase 2 trial concerning the treatment of recurrent glioblastoma (rGBM). The company presented data from the trial at the Congress of Neurological Surgeons (CNS) Annual Meeting, detailing the use of Rhenium (186Re) Obisbemeda, a novel injectable radiotherapy. This therapy aims to deliver targeted high-dose radiation to CNS tumors, potentially reducing risks associated with non-targeted treatments and improving patient outcomes.
Plus Therapeutics faces potential delisting from The Nasdaq Stock Market due to an equity shortfall. Despite this, the company plans to appeal the determination. In the second quarter, the company reported a revenue of $1.3 million, falling short of Ascendiant Capital's anticipated $1.6 to $1.7 million range, leading the firm to revise its 2024 revenue estimates for the company from $7 million to $5 million.
In other developments, Plus Therapeutics shareholders elected six members to the Board of Directors and approved the fourth amendment and restatement of the company's 2020 Stock Incentive Plan. The company also reported a solid financial position with a cash and investments balance of $8.4 million and anticipated grant revenue of $6 million to $7 million for the year. The company also secured a $3 million award from the U.S. Department of Defense for a pediatric brain cancer trial. These are recent developments for Plus Therapeutics.
InvestingPro Insights
As Plus Therapeutics (NASDAQ:PSTV) continues to make strides in its clinical trials for glioblastoma treatment, investors should consider some key financial metrics and insights from InvestingPro.
The company's market capitalization stands at a modest $8.61 million, reflecting its current developmental stage. Despite the promising clinical results, PSTV faces financial challenges typical of early-stage biotech firms. An InvestingPro Tip indicates that the company is "quickly burning through cash," which is not uncommon for businesses investing heavily in research and development.
On a positive note, PSTV holds more cash than debt on its balance sheet, providing some financial flexibility as it advances its clinical programs. However, investors should be aware that the company is not currently profitable, with a negative gross profit margin of -96.46% in the last twelve months as of Q2 2024.
Revenue growth has been substantial, with a 113.2% increase in the last twelve months as of Q2 2024, reaching $5.51 million. This growth aligns with the company's progress in clinical trials and expansion to new research sites. However, the most recent quarter saw a revenue decline of 31.01%, highlighting the volatility often seen in early-stage biotech companies.
For those considering an investment in PSTV, it's worth noting that analysts have revised their earnings expectations downward for the upcoming period, as per another InvestingPro Tip. This could reflect the ongoing cash burn and the uncertainties inherent in drug development.
InvestingPro offers additional tips and insights that could be valuable for investors analyzing PSTV's potential. There are 10 more tips available on the InvestingPro platform, providing a more comprehensive view of the company's financial health and market position.
As Plus Therapeutics continues to navigate the complex landscape of clinical trials and drug development, these financial metrics and insights offer important context for understanding the company's current position and future prospects.
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