On July 21, 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 second quarter ended June 30, 2022, and provided an overview of recent business highlights (Press release, Cytori Therapeutics, JUL 21, 2022, View Source [SID1234616870]).
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"During the second quarter, we maintained the momentum to successfully complete our key corporate goals for 2022," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "Clinical data from our glioblastoma and leptomeningeal metastasis trials, though early in development, continue to show promise and we remain on track to complete key CMC and regulatory objectives."
RECENT HIGHLIGHTS
Rhenium-186 NanoLiposome ( 186 RNL), a novel radiotherapy in development for several rare cancer targets
In July 2022, the Company completed the technology transfer and initiation of cGMP manufacturing of the 186RNL drug intermediate with Piramal Pharma Solutions. Additionally, the intermediate drug product is in stability testing and compliant with the U.S. Food and Drug Administration (FDA) guidance for manufacture of nanoliposomal drug products for use in late-stage clinical trials and commercialization. The Company expects to have GMP drug availability in the second half of 2022 for ongoing and planned clinical trials in adults with recurrent glioblastoma, leptomeningeal metastasis and future disease targets.
In July 2022, at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2022 Annual Meeting, the Company presented positive interim data on the lead investigational drug, 186RNL, from the Phase 1/2a ReSPECT-GBM dose escalation clinical trial in patients with recurrent glioblastoma (GBM). During the presentation, the Company noted that the trial has evaluated 23 adult patients with recurrent GBM across 7 cohorts of increasing dose. To date, there have been no dose limiting toxicities and promising efficacy signals have been observed in patients receiving average absorbed doses of radiation > 100 Gy.
The Company’s principal investigator will provide a full data update on the Phase 1/2a ReSPECT-GBM dose escalation clinical trial at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Meeting in Paris France, September 9-13, 2022.
In the second quarter of 2022, the Company completed enrollment of Cohort 1 of the ReSPECT-LM Phase 1/2a dose escalation trial of 186RNL in patients with leptomeningeal metastases (LM). 186RNL was successfully delivered without dose limiting toxicities in this initial cohort and the independent ReSPECT-LM trial Data Safety & Monitoring board has approved the plan to move ahead with the Cohort 2.
The Company submitted two briefing packages to the FDA to seek their opinion on the recurrent GBM clinical program and CMC development plans.
The Company entered into a multi-year agreement with Biocept, Inc. to employ its cerebrospinal fluid assay in the ReSPECT-LM Phase 1/2a dose-escalation clinical trial. Biocept’s assay provides a highly sensitive method to assess and quantify tumor cell burden in LM of the central nervous system. Assay results will be used to evaluate biologic response to treatment and treatment efficacy for patients enrolling in the ReSPECT-LM trial.
The Company obtained FDA approval for the ReSPECT-GBM multiple dose extension trial.
Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere ( 188 RNL-BAM), a novel radiotherapy in development for solid organ cancers
The Company has completed key technology transfer activities from UT Health Science Center at San Antonio and is on track to complete key CMC feasibility and IND enabling preclinical studies in the fourth quarter of 2022.
SECOND QUARTER 2022 FINANCIAL RESULTS
The Company’s cash balance was $18.1 million at June 30, 2022, compared to $18.4 million at December 31, 2021.
Total operating expenses for the second quarter of 2022 were $5.1 million, compared to total operating expenses of $2.6 million for second quarter of 2021. The increase is due primarily to incremental CMC spend relating to the development of GMP 186RNL drug and key regulatory consulting activities, both of which are on track to be completed in the third quarter of 2022. In addition, to a lesser extent, the Company had a forecasted increase in legal, professional fees and other general corporate expenses.
Net loss for the second quarter of 2022 was $5.3 million, or $(0.24) per share, compared to a net loss of $2.8 million, or $(0.25) per share, for the second quarter of 2021.
UPCOMING EVENTS AND MILESTONES
During the remainder of 2022, the Company expects to accomplish the following key business objectives:
Present updated data from the ReSPECT-GBM and ReSPECT-LM at European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) and Society of Neuro-Oncology scientific conferences.
Receive FDA feedback from CMC and clinical Type C meetings for the recurrent GBM program.
Complete GMP manufacturing milestones for 186RNL.
Submit a protocol for the study of 186RNL in patients with pediatric brain cancer (ReSPECT-PBC).
Complete key CMC & IND-enabling studies for 188RNL-BAM.
Second Quarter 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.