On April 20, 2023 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 first quarter ended March 31, 2023, and provided an overview of recent business highlights (Press release, PLUS THERAPEUTICS, APR 20, 2023, View Source [SID1234630347]).

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"Our team has continued the strong momentum from 2022 through the first quarter of 2023," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "Our 2023 focus is on trial site expansion, patient enrollment and key data readouts for our lead GBM and LM trials, as well as initiating our pediatric trial. Furthermore, we will continue to operate in a capital efficient manner, combining cash on hand with available discretionary sources of capital, existing non-dilutive grant funding and potential new grants we are seeking in 2023."

Q1 HIGHLIGHTS AND MILESTONE ACHIEVEMENTS

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Completed Part A of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM).
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Increased enrollment in the ReSPECT-GBM trials including both the Phase 1/2a dose escalation trial and in the Phase 2b trial for small- to medium-sized tumors.
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Enrolled the required three patients in cohort 8 of the Phase 1/2a dose escalation arm at a dose of 41.5 millicuries of radiation in 16.3 milliliters.
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Added Northwestern Memorial Hospital in Chicago, a world-class medical center and leader in clinical research as an enrolling ReSPECT-LM site.

FIRST QUARTER 2023 FINANCIAL RESULTS

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The Company’s cash balance was $12.7 million at March 31, 2023, compared to $18.1 million at December 31, 2022.
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The Company recognized $506,000 of grant revenue in the first quarter of 2023, which represents the Cancer Prevention & Research Institute of Texas’ (CPRIT) share of costs incurred in the development of rhenium (186Re) obisbemeda for the treatment of patients with LM.
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Total operating expenses for the first quarter of 2023 were $5.2 million, compared to total operating expenses of $3.9 million for the same period the prior year. The increase is due primarily to a $750,000 license payment to NanoTx Corp for successfully meeting a key clinical milestone and related clinical expenses due to increased enrollment in the Company’s lead development programs.
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In addition to current cash on hand, the Company benefits from grant awards of $3 million from the National Institutes of Health (NIH) and $17.6 million from CPRIT. The Company also has discretionary, or stockholder approved access to capital from its ATM and equity line of credit of at least $49 million. In aggregate, these capital sources could provide sufficient capital to fund currently planned and anticipated activities through 2025, if fully utilized.
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Net loss for the first quarter of 2023 was $4.8 million, or $(0.14) per share, compared to a net loss of $4.1 million, or $(0.19) per share, for the same period the prior year.

UPCOMING EVENTS AND MILESTONES

During 2023, the Company expects to accomplish the following key business objectives:

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Publish ReSPECT-GBM Phase 1 data in a peer-reviewed journal.
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Present safety and efficacy data from ReSPECT-GBM trials in the second half of 2023.
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Present safety and efficacy data of Phase 1/Part A of the ReSPECT-LM trial in the second half of 2023.
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Initiate the Phase 1/Part B of the ReSPECT-LM trial in the second half of 2023 following a U.S. Food and Drug Administration (FDA) type C meeting.
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Complete key enrollment and site expansion activities in the ReSPECT-GBM Phase 2b trial for full trial enrollment by year-end 2024.
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Initiate the Phase 1 ReSPECT-PBC trial for pediatric patients with ependymoma and high-grade glioma.
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Determine the appropriate FDA regulatory designation for the 186RNL-BAM technology and complete key development activities.
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Complete key preclinical synergistic drug combination studies of rhenium (186Re) obisbemeda and systemic therapies for GBM and LM.
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Submit multiple grant applications to secure non-dilutive capital to support expansion of the Company’s drug development pipeline.

FIRST QUARTER 2023 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.

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 Investor’section. The webcast will be available on the Company’s website for 90 days following the live call.