On March 5, 2024 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, reported financial results for the fourth quarter and full year ended December 31, 2023, and provided an overview of recent and upcoming business highlights (Press release, Plus Therapeutics, MAR 5, 2024, View Source [SID1234640777]).

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"Based on 2023 achievements and planned 2024 milestones, we intend to move our lead targeted radiotherapeutic into registrational trials in 2025," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "Our ReSPECT clinical trials in both LM and recurrent glioblastoma (rGBM) continue to demonstrate encouraging safety and efficacy signals for rhenium (186Re) obisbemeda and we plan U.S. Food and Drug Administration (FDA) meetings during 2024 to discuss next steps toward product approval."

UPCOMING EVENTS AND MILESTONES

In 2024 the Company plans to accomplish the following key business objectives:

Leptomeningeal Metastasis:

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Present interim safety and feasibility data from the ReSPECT-LM trial at the SNO/ASCO CNS Cancer Conference in August 2024.
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Complete ReSPECT-LM Phase 1 dose escalation trial enrollment, determine the maximum tolerated dose, and recommended Phase 2 dose.
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Present complete ReSPECT-LM Phase 1 data at the SNO Annual Meeting in November 2024.
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Implement Plus’ CNSide cerebral spinal fluid (CSF)-based tumor cell quantification assay as an exploratory clinical endpoint in all ReSPECT-LM trial patients in Q1 2024.
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2024 FDA meeting to align on the design for a pivotal Phase 2/3 ReSPECT-LM trial for the treatment of breast cancer with leptomeningeal metastases, anticipated to begin in 1H 2025.
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Develop a new, multiple dosing ReSPECT-LM clinical trial in 2024.
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Complete preclinical combination studies of rhenium (186Re) obisbemeda with PD-1 and PD-L1 checkpoint inhibitors.

Glioblastoma:

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Continue to advance Phase 2 ReSPECT-GBM trial and present data in the second half of 2024.
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Finalize ReSPECT-GBM pivotal design with FDA.

Pediatric Brain Cancer (PBC)

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Obtain FDA IND approval to begin enrollment of ReSPECT-PBC trial for children with high grade glioma and ependymoma.

Manufacturing:

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Increase GMP manufacturing capacity of rhenium (186Re) obisbemeda to support forecasted Phase 3 and commercial supply requirements.

Q4 2023 AND RECENT HIGHLIGHTS AND MILESTONE ACHIEVEMENTS

Leptomeningeal Metastasis:

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Completed dosing in Cohort 4and initiated dosing in Cohort 5 of the ReSPECT-LM Phase 1 dose escalation trial of rhenium (186Re) obisbemeda for the treatment of LM.
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Added a total of 5 new sites to the ReSPECT trials.
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Partnered with K2bio for implementation of the CNSide cerebrospinal fluid (CSF)-based tumor cell capture and enumeration assay, acquired from Biocept, being utilized in the ReSPECT-LM clinical trial. CNSide assay implementation is now complete.
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Orphan Drug Designation granted to rhenium (186Re) obisbemeda by the FDA for the treatment of breast cancer with LM.
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Presented preliminary safety and efficacy results from Phase 1/Part A of the ReSPECT-LM clinical trial at the SNO/ASCO CNS Cancer Conference. Following the presentation, the Company hosted a key opinion leader roundtable on data presented at the conference.
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Received advance payment of grant funds of approximately $3.3 million from CPRIT as part of its overall $17.6 million award contract. To date, the Company has received $7.1 million in grant funding from CPRIT.
Glioblastoma:

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Presented interim safety and efficacy results from the ongoing ReSPECT-GBM Phase 2 clinical trial at the SNO Annual Meeting. Following the presentation, the Company hosted a key opinion leader webinar to discuss the data presented at the conference.

FULL YEAR 2023 FINANCIAL RESULTS

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The Company’s cash balance was $8.6 million at December 31, 2023, compared to $18.1 million at December 31, 2022.
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The Company recognized $4.9 million and $0.2 million of grant revenue during the years ended December 31, 2023 and 2022, respectively, which represents CPRIT’s share of the costs incurred for our rhenium (186Re) obisbemeda development for the treatment of patients with LM.
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Total operating loss for the year ended December 31, 2023 was $13.3 million compared to $19.7 million in the same period of 2022. The decrease is primarily due to an increase in grant revenue of $4.7 million, offset by a decrease in general and administrative expenses of $1.7 million due to lower professional fees.
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Net loss for the year ended December 31, 2023 was $(13.3) million, or $(4.24) per share, compared to a net loss of $(20.3) million, or $(11.58) per share, for the same period the prior year.

FOURTH QUARTER AND FULL YEAR 2023 RESULTS CONFERENCE CALL

The Company will hold a conference call and live audio webcast at 5:00 pm Eastern Time today to discuss its financial results and provide a general business update.

A live webcast will be available at ir.plustherapeutics.com/events.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.