On April 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 first quarter ended March 31, 2021, and provided an overview of recent business highlights (Press release, Cytori Therapeutics, APR 22, 2021, View Source [SID1234578354]).
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The Company’s lead investigational drug is Rhenium NanoLiposome (RNL), a radiotherapy in development for several rare cancer targets, including recurrent glioblastoma (GBM). RNL, currently being evaluated in the U.S. multi-center ReSPECT Phase 1 dose-finding clinical trial, is designed to safely, effectively, and conveniently deliver a very high dose of radiation directly to brain tumors.
"In the first quarter of 2021, we made meaningful progress in critical areas including advancing our drug development and manufacturing activities, refining our clinical understanding of RNL behavior in the glioblastoma patients and in seeking FDA feedback on potential new clinical indications for RNL," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics.
First Quarter 2021 Clinical Highlights
Company highlights during the first quarter of 2021 included:
Entering into a master services agreement (MSA) with Piramal Pharma Solutions for the development, manufacture, and supply of RNL intermediate drug product.
Completing the 6th dose escalation cohort, with 18 patients treated in ReSPECT, with concomitant increases in both RNL drug volume and radiation dose.
Beginning treatment in an expansion cohort at the 6th dose with higher drug flow rates and faster drug infusion times.
Submitting 2 RNL pre-IND meeting briefing packages to the U.S. Food and Drug Administration (FDA) for treatment of leptomeningeal metastases and pediatric brain cancers, specifically ependymoma, high-grade glioma, and diffuse intrinsic pontine glioma.
Expected Upcoming Clinical Milestones and Events for 2021
In upcoming quarters in 2021, 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 in conjunction with FDA feedback for RNL in recurrent glioblastoma.
Complete a pre-IND meeting with the FDA, execute IND-enabling studies, if needed, and move into clinical trials for new RNL indications.
Continue development and evaluation of additional external and internal drug development candidates to expand the drug development pipeline.
Continue to explore partnership opportunities for three clinical-stage investigational drugs: RNL, DocePLUS and generic DoxoPLUS.
First Quarter 2021 Financial Results
As of March 31, 2021, the Company’s cash balance was $14.4 million, compared to $8.3 million as of December 31, 2020.
Total operating expenses for the first quarter of 2021 was $2.5 million, compared to total operating expenses of $2.56 million for the same quarter in 2020.
Net loss for the first quarter of 2021 was $2.7 million, or $(0.33) per share, compared to a net loss of $1.1 million, or $(0.28) per share, for the same quarter in 2020. The net loss was consistent year on year when excluding the book gains on the warrants reported in Q1 2020. Remeasurement of warrant liabilities was no longer required for Series U warrants that were amended in Q2 and Q3 2020 and reclassified to equity.
First 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 First Quarter 2021 Results Conference Call
Date: Thursday, April 22, 2021
Time: 5:00 p.m. Eastern Time
Live Call: 877-402-3914 (toll free); 631-865-5294 (Intl.); Conference ID: 3084418
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.