On February 24, 2022 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 fourth quarter and full year ended December 31, 2021, and provided an overview of recent business highlights (Press release, Cytori Therapeutics, FEB 24, 2022, View Source [SID1234608960]).

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"In 2021, the Company significantly advanced its lead 186RNL program and expanded its pipeline," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "Our 2022 plan will build on our successful 2021 track record. This year we have planned an aggressive schedule of development activities in conjunction with continued strengthening of our balance sheet".

2021 AND RECENT HIGHLIGHTS

Rhenium-186 NanoLiposome ( 186 RNL), a novel radiotherapy in development for several rare cancer targets

Announced positive interim data from the U.S. ReSPECT-GBM Phase 1/2 trial of 186RNL in patients with recurrent glioblastoma (GBM).
Announced plans to advance into Phase 2 development in 2022 for recurrent GBM.
Initiated ReSPECT-LM Phase 1 dose escalation trial of 186RNL in patients with leptomeningeal metastases (LM).
Received U.S. Food and Drug Administration (FDA) Fast Track designation for 186RNL for the treatment of LM.
Entered into multiple manufacturing, analytical and supply agreements to produce Good Manufacturing Practice (cGMP) grade 186RNL for use in late-stage clinical trials planned for 2022.
Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere ( 188 RNL-BAM), a novel radiotherapy in development for solid organ cancers

In the fourth quarter of 2021, in-licensed a novel targeted radioembolic technology for the treatment of many solid organ tumors.
The in-licensed technology is intended to make and use biodegradable alginate microspheres (BAM) combined with nanoliposomes and imaging and/or therapeutic payloads.
The Company will initially focus on developing 188RNL-BAM as a next-generation radioembolization therapy for rare solid organ cancers including liver cancer.
FULL YEAR 2021 FINANCIAL RESULTS

As of December 31, 2021, the Company’s cash balance was $18.4 million, compared to $8.3 million as of December 31, 2020. In 2021 and in 2022 to date, the Company strengthened its balance sheet by raising $28.5 million. As a result, at January 31, 2022, the Company’s cash balance was $23.0 million.
Through 2021, the Company continued to utilize the $3 million grant from the NIH/National Cancer Institute for funding of the clinical trials for the ReSPECT-GBM Phase 1/2 trial.
Total operating expenses for full year 2021 were $12.5 million, compared to total operating expenses of $9.9 million for full year 2020. This increase is primarily due to increased research and development expenses in 2021.
Net loss for full year 2021 was $13.4 million, or $(1.11) per share, compared to a net loss of $8.2 million, or $(1.86) per share, for full year 2020. The increase in net loss is primarily due to the aforementioned increase in research and development expenses.
UPCOMING EVENTS AND MILESTONES

The Company’s near- and mid-term business objectives include the following:

Recurrent GBM

Initiate a Phase 2 clinical trial in patients with recurrent GBM.
Complete FDA CMC and clinical meetings for the ReSPECT-GBM program.
Complete CMC activities for 186RNL for GMP Phase 2 drug supply.
Continue ReSPECT-GBM Phase 1 trial of 186RNL, dose escalation and report data.
Initiate ReSPECT-GBM retreatment protocol following FDA approval.
Other Indications

Complete initial cohort enrollment and feasibility assessment in ReSPECT-LM Phase 1 trial.
Obtain FDA approval of Investigational New Drug (IND) application for Phase 1 trial of 186RNL in patients with pediatric brain cancer (ReSPECT-PBC).
Complete technology transfer and key CMC, FDA IND-enabling studies for 188RNL-BAM.
FOURTH QUARTER AND FULL YEAR 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 Fourth Quarter and Full Year 2021 Results Conference Call
Date: February 24, 2022
Time: 5:00 p.m. Eastern Time
Live Call: 866-342-8591 (toll free); 203-518-9713 (Intl.); Conference ID: PSTVQ421
The webcast can be accessed live via the Investor Relations 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.