On February 23, 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 fourth quarter and year ended December 31, 2022, and provided an overview of recent business highlights (Press release, Cytori Therapeutics, FEB 23, 2023, View Source [SID1234627640]).

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"During 2022, we made significant progess in our co-lead radiotherapeutic programs for recurrent glioblastoma (GBM) and LM. Furthermore, even during a turbulent time in the U.S. capital markets, we reached a new level of balance sheet stability to support our exciting and potentially game-changing targeted radiotherapeutic drug candidates," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "In 2023, we intend to build on the success of 2022 to simultaneously advance our active programs in GBM and LM and also broaden and diversify our drug development pipeline."

2022 AND 2023 HIGHLIGHTS AND MILESTONE ACHIEVEMENTS

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Completed multi-year program, including related U.S. Food and Drug Administration (FDA) interactions, to produce GMP rhenium (186Re) obisbemeda for Phase 2 clinical trials.
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Enrolled first patient in the Phase 2b clinical trial of rhenium (186Re) obisbemeda for recurrent GBM. Presented data from the ReSPECT-GBM Phase 1/2a dose escalation trial evaluating rhenium (186Re) obisbemeda in patients with recurrent GBM at the 27th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO).
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Awarded $17.6 million CPRIT grant to support Phase 1 and Phase 2 clinical development of rhenium (186Re) obisbemeda for LM.
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Completed enrollment in the second cohort of the ReSPECT-LM Phase 1 clinical trial of rhenium (186Re) obisbemeda for the treatment of LM.
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Presented initial clinical experience from the ReSPECT-LM Phase 1/2a dose escalation trial evaluating rhenium (186Re) obisbemeda in patients with LM at the 27thAnnual Scientific Meeting and Education Day of SNO.
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Engaged with the FDA on proposed Investigational New Drug (IND) application to treat pediatric patients with ependymoma and high-grade glioma.
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Licensed bioresorbable radio-embolic technology platform (186RNL-BAM) from the University of Texas and completed key manufacturing and preclinical human ex vivo and proof of concept activities as well as initial FDA interactions.
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Announced a comprehensive laboratory services agreement with Biocept to use the CNSide assay to evaluate response to treatment and treatment efficacy in the ReSPECT-LM clinical trial.
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Executed a variety of agreements and transactions to supplement the balance sheet and raised capital expected to be sufficient to fund expenses through 2025.

FULL YEAR 2022 FINANCIAL RESULTS

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The Company’s cash balance was $18.1 million at December 31, 2022, compared to $18.4 million at December 31, 2021. The Company believes that current cash on hand, anticipated funding from both the National Institutes of Health and CPRIT, and existing discretionary capital sources are sufficient to fund both its currently planned and anticipated overhead and development expenses through 2025.
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Grant revenue of $224,000 was recognized for full year 2022, which represents CPRIT’s initial share of the costs incurred for development of 186RNL for the treatment of patients with LM. During the fourth quarter of 2022, the Company received its first CPRIT grant funds of approximately $1.9 million.
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Total operating expenses for full year 2022 were $19.9 million, compared to total operating expenses of $12.5 million for full year 2021. The increase is due primarily to incremental CMC spend related to the development of GMP 186RNL drug and key regulatory consulting activities. In addition, to a lesser extent, the Company had a one-time forecasted increase in general corporate expenses together with litigation and legal expenses primarily related to resolving a legal dispute.
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Net loss for full year 2022 was $20.3 million, or $(0.77) per share, compared to a net loss of $13.4 million, or $(1.11) per share, for full year 2021.

UPCOMING EVENTS AND MILESTONES

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

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Expand clinical sites and make enrollment progress of the ReSPECT-GBM Phase 2b trial to support enrollment completion by the end of 2024.
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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 Phase 1/2a dose escalation trial and ReSPECT-GBM Phase 2b dose expansion trial in the second half of 2023.
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Complete enrollment in Phase 1/Part A of the ReSPECT-LM trial, expand the number of trial sites, and begin enrollment in Phase 1/Part B.
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Present clinical safety and efficacy data of Phase 1/Part A of the ReSPECT-LM trial in the second half of 2023.
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Explore potentially synergistic drug combination studies of locally delivered rhenium (186Re) obisbemeda and promising systemic therapies in relevant preclinical models of LM.
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Finalize and submit an FDA IND application to treat pediatric patients with ependymoma and high-grade glioma and begin enrollment.
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In conjunction with the FDA, finalize regulatory designation of 186RNL-BAM technology and complete key development activities.
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Execute corporate partnerships to expand the business opportunities for Plus Therapeutics’ unique CNS oncology platform.
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Submit multiple grants to secure non-dilutive capital to support expansion of the Company’s drug development pipeline.

FOURTH QUARTER AND FULL YEAR 2022 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.