On October 21, 2021 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 third quarter ended September 30, 2021, and provided an overview of recent business highlights (Press release, Cytori Therapeutics, OCT 21, 2021, View Source [SID1234591764]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"In the third quarter, we made meaningful progress executing our strategy to develop novel radiotherapeutics for rare and central nervous system cancers," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "We increased the ReSPECT-GBM trial dose by 40%, were accepted to present an update of the ReSPECT-GBM trial data at the 2021 Society for Neuro-Oncology Annual Meeting in November, received clearance from the U.S. Food and Drug Administration for our Investigational New Drug application for leptomeningeal metastases, entered into an additional agreement for the production of our radiopharmaceutical products, and strengthened our leadership team with the appointment of a highly experienced Chief Medical Officer with decades of radiopharmaceutical development experience."
RECENT HIGHLIGHTS
Rhenium-186 NanoLiposome ( 186 RNL), a novel radiotherapy in development for several rare cancer targets
Recurrent Glioblastoma (GBM)
The ongoing U.S. multi-center ReSPECT-GBM Phase 1 dose-finding clinical trial is designed to safely and effectively deliver high doses of radiation directly to brain tumors. Thus far, 22 patients with recurrent GBM have been treated in the ReSPECT-GBM trial across eight cohorts. A 40% increase in absorbed radiation doses per tumor in Cohort 8 over Cohort 7 have been achieved without dose-limiting toxicities. Patient recruitment continues at UT Health San Antonio, UT Southwestern in Dallas, and MD Anderson in Houston. Learn more at ClinicalTrials.gov.
The Company will present interim data from its ReSPECT-GBM clinical trial at the 2021 American Society for Radiation Oncology (ASTRO) Annual Meeting scheduled October 24-27, 2021 and at the 2021 Society for Neuro-Oncology (SNO) Annual Meeting and Education Day scheduled November 18-21, 2021.
The Company will host a roundtable discussion of the ReSPECT-GBM clinical trial on November 18, 2021 at 4:00 p.m. EST, which will be webcast, with Toral Patel, M.D., Associate Professor, Department of Neurosurgery, UT Southwestern Medical Center, and Andrew J. Brenner, M.D., Ph.D., Professor of Medicine, Neurology, and Neurosurgery at The University of Texas.
Leptomeningeal Metastases (LM)
The Company received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for 186RNL for the treatment of LM.
The Company expects to initiate patient accrual in a Phase 1 dose escalation trial of 186RNL (ReSPECT-LM) in the fourth quarter of 2021.
ReSPECT-LM will be a multi-center, sequential cohort, open-label, single dose, dose escalation Phase 1 study of the safety, tolerability, biodistribution, dosimetry, and anti-tumor activity of 186RNL given intraventricularly via an Ommaya reservoir to subjects over 18 years old with LM. The primary endpoints of the study are the incidence and severity of adverse events and serious adverse events and the incidence of dose limiting toxicities. The secondary endpoints are the overall response rate, duration or response, progression free survival, and overall survival. Learn more at ClinicalTrials.gov.
Pediatric Brain Cancer (PBC)
The Company intends to submit an IND application to the FDA for 186RNL for the treatment of PBC. The Company expects to initiate patient accrual in a Phase 1 dose escalation trial of 186RNL (ReSPECT-PBC) in 2022.
Drug Manufacturing and Supply Chain
During the third quarter of 2021, the Company entered into an agreement with RadioMedix, Inc. for the commercial production of the Company’s investigational radiopharmaceuticals. Thus far in 2021, the Company has entered into five collaboration agreements to support its process development and analytical chemistry activities, as well as to strengthen its supply chain in compliance with current good manufacturing practices (GMP) for the manufacture of 186RNL. The Company remains on track to deliver GMP 186RNL by mid-2022.
Corporate
During the third quarter of 2021, the Company announced the appointment of Norman LaFrance, M.D. to the position of Chief Medical Officer and Senior Vice President. Dr. LaFrance joins Plus Therapeutics with nearly 40 years of experience as a nuclear medicine physician and as an executive in the pharmaceutical and healthcare industries. Dr. LaFrance area of specialization is radiotherapeutic drug research and development as well as regulatory approval and commercialization of molecular imaging, diagnostic and therapeutic products.
UPCOMING EVENTS AND MILESTONES
Over the next 12 months, the Company intends to accomplish the following key business objectives:
Complete enrollment of the ongoing cohort in the ReSPECT-GBM Phase 1 clinical trial.
Fully analyze the ReSPECT-GBM Phase 1 clinical trial data and refine its Phase 2/3 clinical trial plans with the FDA.
Initiate patient accrual in the Phase 1 ReSPECT-LM clinical trial.
Submit an IND application to the FDA for 186RNL for the treatment of patients with PBC.
Complete CMC activities for GMP 186RNL and complete CMC related meeting with the FDA.
THIRD QUARTER 2021 FINANCIAL RESULTS
As of September 30, 2021, the Company’s cash balance was $21.3 million, compared to $8.3 million as of December 31, 2020.
Total operating expenses for the third quarter of 2021 were $3.5 million, compared to total operating expenses of $1.4 million for the same quarter in 2020. This increase is primarily due to increased research and development expenses in 2021.
Net loss for the third quarter of 2021 was $3.7 million, or $(0.28) per share, compared to a net loss of $1.7 million, or $(0.39) per share, for the same quarter in 2020. The increase in net loss is primarily due to the aforementioned increase in research and development expenses.
Third Quarter 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 Third Quarter 2021 Results Conference Call
Date: Thursday, October 21, 2021
Time: 5:00 p.m. Eastern Time
Live Call: 877-876-9173 (toll free); 785-424-1667 (Intl.); Conference ID: PSTVQ321
The webcast can be accessed live via the investor 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.