On July 22, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported financial results for the second quarter ended June 30, 2021, and provided an overview of recent business highlights (Press release, Cytori Therapeutics, JUL 22, 2021, View Source [SID1234585083]).
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"Our focus remains on completion of our Phase 1 dose escalation ReSPECT-GBM trial, which is evaluating the Company’s lead investigational drug, Rhenium-186 NanoLiposome (186RNL) in recurrent glioblastoma (GBM), expansion of our 186RNL pipeline, and GMP production of 186RNL to be available in mid-2022 for a potential registrational trial," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "We believe that the evolving clinical data in ReSPECT shows that high doses of precisely delivered beta radiation in patients with recurrent GBM is both feasible and safe. We intend to provide a comprehensive update on the data later this year."
RECENT HIGHLIGHTS
Rhenium-186 NanoLiposome ( 186 RNL), a novel radiotherapy in development for several rare cancer targets
Recurrent Glioblastoma (GBM)
The U.S. multi-center ReSPECT-GBM Phase 1 dose-finding clinical trial is designed to safely and effectively deliver high doses of radiation directly to brain tumors. Thus far, 22 patients with recurrent GBM have been treated in the ReSPECT-GBM trial across eight cohorts. Absorbed radiation doses of up to 740 Gray per tumor have been achieved without dose-limiting toxicities.
In June 2021, the Data and Safety Monitoring Board (DSMB) recommended the Company proceed to the eighth dosing cohort of the ReSPECT-GBM trial, which implemented a 40% increase in total radioactivity and volume. The first patient in the eighth cohort was treated in July 2021.
Leptomeningeal Metastases (LM)
In the second quarter of 2021, the Company received a positive response to the 186RNL pre-Investigational New Drug (IND) meeting briefing package that it submitted in the first quarter of 2021 to the U.S. Food and Drug Administration (FDA) for the treatment of LM.
The Company intends to submit an IND application to the FDA and, upon approval, begin a ReSPECT-LM Phase 1 clinical trial of 186RNL for the treatment of LM by the end of 2021.
Pediatric Brain Cancer (PBC)
In the first quarter of 2021, the Company submitted a 186RNL pre-IND meeting briefing package to the FDA for treatment of various pediatric brain cancers.
Based on the feedback from the FDA, the Company is not required to perform additional preclinical or toxicology studies and intends to submit an IND application to begin a ReSPECT-PBC Phase 1 clinical trial of 186RNL for the treatment of pediatric brain cancer in 2022.
On June 10, 2021, a poster titled, "A two-part, Phase I study of Rhenium-186 Nanoliposomes (186RNL) delivered by convection enhanced delivery (CED) for recurrent, refractory, or progressive ependymoma and high-grade glioma (HGG)" was presented at the 6th Biennial Pediatric Neuro-Oncology Research Conference. The data included a review of relevant preclinical research, the Company’s Phase 1 ReSPECT-GBM clinical trial and a proposed design for initiating a Phase I clinical trial in PBC.
Commercial Manufacturing and Supply Chain
Thus far in 2021, the Company has entered into four collaboration agreements to support the Company’s process development and analytical chemistry activities, as well as to strengthen its commercial supply chain in compliance with current good manufacturing practices (cGMP), for the manufacture of commercial grade 186RNL.
EXPECTED UPCOMING CLINICAL MILESTONES AND EVENTS FOR 2021
During the remainder of 2021, the Company intends to focus on the following key business objectives and milestones:
Complete enrollment of the eighth cohort in the company’s ReSPECT-GBM Phase 1 clinical trial.
Complete pivotal trial planning in conjunction with the FDA feedback for 186RNL in recurrent GBM.
Submit IND applications to initiate clinical investigation of 186RNL for LM and PBC.
Complete planned 2021 CMC activities such that cGMP 186RNL will be available in mid-2022.
SECOND QUARTER 2021 FINANCIAL RESULTS
As of June 30, 2021, the Company’s cash balance was $17.2 million, compared to $8.3 million as of December 31, 2020.
Total operating expenses for the second quarter of 2021 were $2.6 million, compared to total operating expenses of $2.5 million for the same quarter in 2020.
Net loss for the second quarter of 2021 was $2.8 million, or $(0.25) per share, compared to a net loss of $1.8 million, or $(0.45) per share, for the same quarter in 2020. The increase in net loss is primarily due to the gain in the fair value of warrants in the second quarter of 2020.
Second Quarter 2021 Results Conference Call
The Company will hold a conference call and live audio webcast at 5:00 p.m. Eastern Time today to discuss its financial results and provide a general business update.
Event: Plus Therapeutics Second Quarter 2021 Results Conference Call
Date: Thursday, July 22, 2021
Time: 5:00 p.m. Eastern Time
Live Call: 877-876-9174 (toll free); 785-424-1669 (Intl.); Conference ID: PSTVQ221
The webcast can be accessed live via the investor section of the Plus Therapeutics website at ir.plustherapeutics.com/events and will be available for replay beginning two hours after the conclusion of the conference call.