Plus Therapeutics Inc Stock Price, News & Analysis

Plus Therapeutics (PSTV), a clinical-stage pharmaceutical company focused on targeted radiotherapeutics for CNS cancers, has granted stock options to its new Chief Development Officer, Dr. Michael Rosol.

The equity award consists of options to purchase 30,000 shares of company common stock, with a four-year vesting schedule. One-fourth of the options will vest on the first anniversary, followed by equal monthly installments thereafter. The exercise price is set at the closing price of PSTV's common stock on February 28, 2025.

The options, granted outside the Company's 2020 Incentive Plan but with similar terms, are subject to Dr. Rosol's continued employment. The company has filed a Form S-8 for these equity awards, aiming to align the executive's interests with shareholders.

Plus Therapeutics (PSTV) has announced a private placement expected to generate approximately $15.0 million in gross proceeds. The offering comprises 28,042,140 common units at $0.66 per unit, with 22,727,270 units for new capital and 5,314,870 units exchanged for existing convertible notes.

Each unit includes one share of common stock (or pre-funded warrant), one Series A warrant (exercise price $1.32, 60-month term), and one Series B warrant (exercise price $1.98, 30-month term). The transaction is expected to close around March 4, 2025, subject to conditions including Nasdaq delisting clearance by March 31, 2025.

The proceeds will be used for repaying outstanding promissory notes, warrant repurchases, and general corporate purposes. D. Boral Capital serves as Placement Agent for this offering restricted to accredited investors.

Plus Therapeutics (PSTV) has completed its ReSPECT-LM Phase 1 single-dose escalation trial for Rhenium (186Re) Obisbemeda, determining the recommended Phase 2 dose (RP2D) for treating leptomeningeal metastases (LM).

Key findings include:

• Cohort 4 dose of 44.1 mCi established as the RP2D
• No dose-limiting toxicities observed at the RP2D level
• One patient at Cohort 4 achieved complete response with tumor cells eliminated from cerebrospinal fluid
• Cohort 6 enrollment completed at 75.0 mCi dose

The company is now advancing both a single dose-expansion Phase 2 trial and a multiple-dose Phase 1 trial using 44.1 mCi fractionated into three doses. Plus Therapeutics expects to complete enrollment in both trials this year while engaging with the FDA to define the optimal pivotal trial pathway.

Plus Therapeutics (NASDAQ: PSTV) has announced key leadership appointments for its CNSide Diagnostics subsidiary. Russell Bradley has been named President and General Manager, bringing over 30 years of leadership experience in diagnostics from companies like Abbott Laboratories, Luminex , and Beckman Coulter.

The company has also appointed Dr. Marc Hedrick, Rick Hawkins, and Russell Bradley to the CNSide Board of Directors. Additionally, Dr. Jonathan Stein has been appointed as CNSide Medical Director, bringing 20 years of expertise in molecular diagnostics, assay development, and regulatory compliance.

CNSide Diagnostics plans to begin a pilot market introduction this quarter, focusing on developing improved tools for testing and treating leptomeningeal disease. The subsidiary aims to secure full capitalization to support early access and initial launch plans in the U.S.

Plus Therapeutics (PSTV) has appointed Dr. Michael Rosol as Chief Development Officer to lead the company's clinical, pre-clinical, and biomarker development activities. Dr. Rosol brings 25 years of experience in clinical trial design, operations, and regulatory execution to the company, which is preparing to move from mid-stage to pivotal trials next year.

Previously serving as Chief Medical Officer and Senior Vice President at Navidea Biopharmaceuticals, Dr. Rosol also worked at Novartis Pharmaceuticals leading biomarker development and translational imaging groups. His academic background includes a Ph.D. from Boston University focusing on biomedical and radionuclide imaging, and appointments at prestigious institutions including Harvard Medical School/Massachusetts General Hospital and Mayo Clinic.

Plus Therapeutics (PSTV) has secured $5.7 million in financing through two sources: a $3.7 million private placement from existing investors and a $2.0 million advance payment from the Cancer Prevention and Research Institute of Texas (CPRIT). The funding will support the clinical development of Rhenium (186Re) Obisbemeda for leptomeningeal metastases (LM) and the development of CNSide LM diagnostic test.

The private placement includes secured convertible promissory notes totaling $3,362,251 and warrants to purchase up to 3,002,009 shares at $1.12 per share. The notes mature in one year, bear 10% annual interest, and are convertible into common stock. The $2.0 million CPRIT advance is part of an existing $17.6 million grant, with approximately $5.2 million remaining.

Additionally, the company issued Exchange Notes worth $3,188,922 in exchange for canceling 3,543,247 Series A warrants from May 2024.

Plus Therapeutics (PSTV) presented interim Phase 1 data for its ReSPECT-LM clinical trial of Rhenium Obisbemeda in leptomeningeal metastases, focusing on breast cancer patients. Nine of 20 patients with LM primary breast cancer were treated across five dose escalation cohorts. The treatment showed promising results with 88% circulating tumor cell response rate and 75% MRI imaging clinical benefit rate. Only one dose-limiting toxicity was reported, and the median overall survival was 9 months, with 2 patients surviving beyond 600 days. The company plans to initiate a Phase 1b single-dose breast expansion cohort in Q1 2025.

Plus Therapeutics (PSTV) will present Phase 1 interim data for its ReSPECT-LM trial at the 2024 San Antonio Breast Cancer Symposium. The presentation will focus on Rhenium (186Re) Obisbemeda treatment for leptomeningeal metastases (LM) in breast cancer patients.

The presentation, led by Dr. Andrew Brenner from the University of Texas Health Science Center, is scheduled for December 13, 2024. LM is a rare but serious cancer complication affecting the cerebrospinal fluid and leptomeninges, with breast cancer being the most common primary cancer leading to LM. The condition affects 3-5% of breast cancer patients and has a poor prognosis, with 1-year and 2-year survival rates of only 7% and 3%, respectively. Currently, there are no FDA-approved therapies specifically for LM.

Plus Therapeutics (Nasdaq: PSTV) has renewed its Master Services Agreement with Telix IsoTherapeutics Group for the supply of cGMP rhenium-186 (Re-186), a key radioisotope used in their lead radiotherapeutic candidate Rhenium (186Re) Obisbemeda. The five-year renewable agreement ensures reliable supply for late-stage clinical trials and commercial needs. This agreement complements their partnership with SpectronRx for final drug manufacturing, establishing a comprehensive end-to-end supply chain. The agreement focuses on producing aluminum perrhenate radionuclide intermediate and final processing of cGMP Re-186, enabling scalable, just-in-time manufacturing.