On February 22, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted therapies for rare and difficult to treat cancers, reported financial results for the fourth quarter and full year ended December 31, 2020, and provided an overview of recent business highlights (Press release, Cytori Therapeutics, FEB 22, 2021, View Source [SID1234575372]).
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"In the second quarter of 2020, we in-licensed a promising new radiotherapeutic platform and portfolio of investigational drugs, then made substantial clinical progress for the lead compound and also moved additional opportunities closer to clinical phase," said Marc Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "In 2021, we intend to make even greater progress advancing our CNS oncology portfolio through the development process and bringing it closer to a potential registrational clinical trial read out."
Rhenium NanoLiposome (RNL) Program – Background and 2020 Highlights
The Company’s lead investigational drug is RNL, a radiotherapy in development for several rare cancer targets, including recurrent glioblastoma (GBM) in the U.S. multi-center ReSPECT Phase 1 dose-finding trial. RNL is designed to safely, effectively, and conveniently deliver a very high dose of radiation directly into the brain tumor compared to traditional external beam radiation therapy (EBRT). 2020 highlights for RNL include:
ReSPECT trial of RNL for recurrent glioblastoma supported by a multi-phase and multi-year financial grant from the U.S. National Institutes of Health/National Cancer Institute (NIH/NCI).
RNL received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of GBM.
Presented positive interim data from the first 15 patients, through Cohort 5, in the ReSPECT trial at the 2020 Society for Neuro-Oncology Annual Meeting (SNO 2020 E-poster).
Completed the 6th dose escalation cohort, with 18 total patients treated in ReSPECT, with increases in both the RNL drug volume and radiation dose.
Thus far, RNL can be successfully delivered with up to 15 times the absorbed dose of radiation administered by standard EBRT without significant toxicity.
ReSPECT clinical trial expanded to two additional locations.
Established Clinical Advisory and Scientific Advisory Boards with leading experts in the fields of neurosurgery, neuro-oncology, preclinical drug development, and nanotechnology.
Expected Upcoming Milestones and Events
In upcoming quarters, the Company intends to focus on a number of additional business objectives and potential milestones:
Complete enrollment of the ReSPECT Phase 1 trial for RNL in recurrent glioblastoma.
Complete pivotal trial planning with FDA for RNL in recurrent glioblastoma.
Complete pre-IND meeting with the FDA, execute IND-enabling studies, if needed, and move into clinical trials for follow-on RNL indications, leptomeningeal metastases and pediatric brain cancer.
Continue development and evaluation of additional external and internal drug development candidates to expand the pipeline.
Continue partnership discussions for three clinical-stage injectable drugs: RNL, DocePLUS, and generic DoxoPLUS.
Fourth Quarter 2020 Financial Results
As of December 31, 2020, the Company’s cash balance was $8.3 million, compared to $17.6 million as of December 31, 2019.
Net cash used in operating activities was $8.4 million for the year ended December 31, 2020, compared to net cash used in operating activities of $5.9 million during the same period in 2019.
During the second quarter of 2020, $5.0 million of the Oxford debt principal was paid down to a current principal balance of $4.3 million at December 31, 2020.
Net loss for full year 2020 was $8.2 million, or $(1.86) per share, compared to a net loss of $11.4 million, or $(8.27) per share (on a fully diluted basis including preferred stock), for full year 2019.
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 Fourth Quarter and Full Year 2020 Financial Results Conference Call and Webcast
Date: Monday, February 22, 2021
Time: 5:00 p.m. Eastern Time
Live Call: 877-402-3914 (toll free); 631-865-5294 (Intl.); Conference ID: 6206747
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.