On October 20, 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 third quarter ended September 30, 2022, and provided an overview of recent business highlights (Press release, PLUS THERAPEUTICS, OCT 20, 2022, View Source [SID1234622267]).
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"The third quarter of 2022 was another period of significant progress for Plus Therapeutics, highlighted by the achievement of three key milestones," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "First, our CPRIT award of $17.6 million substantially funds the LM program through Phase 2 for our lead investigational drug, Rhenium-186 Nanoliposome (186RNL). Second, we moved 186RNL toward a Phase 2 trial for recurrent GBM, which we expect to initiate in the fourth quarter of 2022. Third, we met our timeline for cGMP 186RNL drug availability for all future trials. In addition, the combination of current cash, committed grant funding in conjunction with existing discretionary capital sources, secures our cash runway through 2025."
RECENT HIGHLIGHTS
On September 9, 2022, Dr. Andrew Brenner, ReSPECT-GBM trial principal investigator, presented Phase 1 results from the ReSPECT-GBM Phase 1/2a dose escalation trial evaluating 186RNL in patients with recurrent GBM at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022. The Phase 1 results demonstrated safety and a potential efficacy signal in heavily pretreated patients with recurrent GBM.
On August 17, 2022, Plus Therapeutics announced the award of a three-year, $17.6 million Product Development Research grant by the Cancer Prevention & Research Institute of Texas (CPRIT) to fund 186RNL for the treatment of patients with LM.
On August 29, 2022, Plus announced a summary of its Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the CMC program for 186RNL. The Company determined that it may proceed in utilizing its 186RNL in its planned Phase 2 programs.
On September 6, 2022, Plus announced a summary of its Type C meeting with the FDA regarding its clinical development program for 186RNL for recurrent GBM. Based on that meeting, the Company plans to begin a Phase 2 trial of 186RNL in patients with recurrent GBM, with a focus on small and medium-sized tumors. The Company will also continue exploration of both higher and multiple doses of 186RNL.
The Company initiated enrollment of Cohort 2 of the ReSPECT-LM Phase 1/2a dose escalation trial of 186RNL in patients with LM.
On October 18, 2022, at the 35th Annual Congress of the European Association of Nuclear Medicine (EANM), the Company presented data from two ongoing clinical trials evaluating 186RNL in recurrent GBM and LM. The findings presented at EANM indicate the potential for 186RNL as a safe, well-tolerated and promising radiotherapeutic for both GBM and LM.
THIRD QUARTER 2022 FINANCIAL RESULTS
The Company’s cash balance was $20.3 million at September 30, 2022, compared to $18.4 million at December 31, 2021. The Company believes that the current cash on hand, anticipated funding from the National Institutes of Health (NIH) and CPRIT and existing discretionary capital sources are sufficient to fund both its currently planned overhead and development expenses through 2025.
Grant revenue of $73,000 was recognized in the third quarter of 2022, which represents CPRIT’s initial share of the costs incurred for development of 186RNL for the treatment of patients with LM. The Company expects the first CPRIT grant funds of approximately $1.9 million to be disbursed to the Company by October 31, 2022.
Total operating expenses for the third quarter of 2022 were $5.2 million, compared to total operating expenses of $3.5 million for the third quarter of 2021. The increase is due primarily to incremental CMC spend, now winding down, related to the development of GMP 186RNL drug and key regulatory consulting activities. In addition, to a lesser extent, the Company had a forecasted increase in litigation, legal, professional fees and other general corporate expenses.
Net loss for the third quarter of 2022 was $5.2 million, or $(0.19) per share, compared to a net loss of $3.7 million, or $(0.28) per share, for the third quarter of 2021.
UPCOMING EVENTS AND MILESTONES
During the remainder of 2022, the Company expects to accomplish the following key business objectives:
ReSPECT-GBM Phase 2 clinical trial initiation
Present updated data from the ReSPECT-GBM and ReSPECT-LM trials at the Society for Neuro-Oncology (SNO) Annual Meeting and Education Day, November 17-20, 2022
Complete Cohort 2 of ReSPECT-LM Phase 1/2a dose escalation trial
Submit an Investigational New Drug (IND) application to the FDA for the study of 186RNL in patients with pediatric brain cancer (ReSPECT-PBC), ependymoma and high-grade glioma
Complete certain key CMC and IND-enabling studies for 188RNL-BAM
Third 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.