On October 22, 2020 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), reported financial results for the third quarter ended September 30, 2020, and provided an overview of recent business highlights (Press release, PLUS THERAPEUTICS, OCT 22, 2020, View Source [SID1234572294]).
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"Our lead investigational drug, RNL for recurrent glioblastoma, continues to progress toward its first major data readout," said Dr. Marc Hedrick, President and Chief Executive Officer of Plus Therapeutics. "In the third quarter, we advanced RNL successfully to the sixth dosing cohort and we are now administering over 1,000% more radiation to patients in a single treatment than can be delivered with traditional external beam radiation therapy."
Third Quarter 2020 and Recent Clinical Highlights
Plus Therapeutics has three clinical stage, nanoscale injectable oncology drugs, each designed to provide enhanced benefits versus existing therapies. The Company’s lead investigational drug is Rhenium NanoLiposome (RNL), a radiotherapy being developed for several cancer targets. RNL is being evaluated in the U.S. NIH/NCI-supported, multi-center ReSPECT Phase 1 dose-finding trial and for the treatment of recurrent glioblastoma. RNL is designed to safely, effectively, and conveniently deliver a targeted and very high dose of radiation directly to brain tumors. In addition:
The U.S. Food and Drug Administration (FDA) granted the Company Orphan Drug and Fast Track Designations for RNL for the treatment of glioblastoma patients.
The Company established a Clinical Advisory Board of five leading experts in the fields of neurological surgery and neuro-oncology that will advise the Company as it advances its nanoscale therapeutics to treat rare brain and neurological cancers.
The independent Data and Safety Monitoring Board (DSMB) of the ReSPECT Phase 1 trial in recurrent glioblastoma approved the Company to commence enrollment in the sixth cohort of patients.
Expected Upcoming Milestones and Events
The first nine months of 2020 marked the successful implementation of the Company’s expanded development focus, pipeline expansion and optimized costs and operational structure. In upcoming quarters, the Company intends to focus on a number of additional business objectives and potential milestones:
Report preliminary RNL data from the ReSPECT Phase 1 dose-finding trial in recurrent glioblastoma at the Society of Neuro-Oncology Annual Meeting being held virtually November 19-22, 2020.
Finalize plans for the next stage of clinical development for RNL in recurrent glioblastoma.
Continue evaluations of additional external and internal drug development candidates.
Initiate IND-enabling RNL studies for additional indications.
Explore partnership opportunities for RNL, DocePLUS and DoxoPLUS assets.
Third Quarter 20 20 Financial Results
As of September 30, 2020, the Company had cash of approximately $7.6 million, compared to cash of approximately $17.6 million as of December 31, 2019. During the third quarter of 2020, 317,521 series U warrants were exercised, raising $0.7 million. Net cash used in operating activities was $5.2 million for the nine months ended September 30, 2020, compared to net cash used of $6.9 million during the same period in 2019. During the second quarter of 2020, $5 million of the Oxford debt principal was paid down.
On September 30, 2020, the Company entered into a purchase agreement and registration rights agreement with Lincoln Park Capital Fund, LLC (LPC) pursuant to which and following the filing and effectiveness of a registration statement, the Company will have the right at its sole discretion, but not the obligation, to sell to LPC up to $25 million worth of shares over the 36-month term of the agreement, subject to various terms and conditions.
On October 9, 2020 the Company filed a shelf registration on Form S-3 allowing for the sale of securities "at the market" of up to $10 million.
Loss from continuing operations for the third quarter 2020 was $1.7 million, or $(0.39) per share, compared to operating income of $0.5 million, or $(0.03) per share (on a fully diluted basis including preferred stock), for the same period in 2019.
Net loss in the third quarter of 2020 was $1.7 million, or $(0.39) per share, compared to net income of $0.5 million, or $(0.03) per share (on a fully diluted basis including preferred stock), for the third quarter of 2019.
Clinical expenses relating to the ReSPECT Phase 1 dose-finding trial in recurrent glioblastoma continue to be funded under a $3 million grant with the U.S. NIH/NCI.
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 2020 Financial Results Conference Call and Webcast
Date: Thursday, October 22, 2020
Time: 5:00 p.m. Eastern Time.
Live Call: 877-402-3914; 631-865-5294 (Intl.); Conference ID: 2108916
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.