Release Details

Plus Therapeutics Reports Third Quarter 2022 Financial Results and Business Highlights

October 20, 2022

Awarded $17.6 million Product Development Research grant by the Cancer Prevention & Research Institute of Texas (CPRIT) to fund 186RNL development for leptomeningeal metastases (LM)

Completed cGMP manufacturing objectives to support Phase 2 clinical trials for 186RNL

Initiating ReSPECT-GBM Phase 2 trial for recurrent glioblastoma (GBM) in Q4 2022

Management to host conference call today at 5:00 p.m. ET

AUSTIN, Texas, Oct. 20, 2022 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced financial results for the third quarter ended September 30, 2022, and provided an overview of recent business highlights.

“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.”


  • 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) 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.


  • 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.


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

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.

About Plus Therapeutics

Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on the development, manufacture, and commercialization of complex and innovative treatments for patients battling cancer and other life-threatening diseases. Our proprietary nanotechnology platform is currently centered around the enhanced delivery of a variety of drugs using novel liposomal encapsulation technology. Liposomal encapsulation has been extensively explored and undergone significant technical and commercial advances since it was first developed. Our platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at and

Cautionary Statement Regarding Forward-Looking Statements

This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186RNL including the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186RNL; the continued evaluation of 186RNL including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.

The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.

(in thousands, except share and par value data)
  September 30, 2022  December 31, 2021 
Current assets:      
Cash and cash equivalents $20,266  $18,400 
Grant receivable  73    
Other current assets  540   1,324 
Total current assets  20,879   19,724 
Property and equipment, net  1,453   1,477 
Operating lease right-use-of assets  275   341 
Goodwill  372   372 
Intangible assets, net  113   51 
Other assets  12   16 
Total assets $23,104  $21,981 
Liabilities and Stockholders’ Equity      
Current liabilities:      
Accounts payable and accrued expenses $5,705  $4,151 
Operating lease liability  107   111 
Term loan obligation, current  1,608   1,608 
Total current liabilities  7,420   5,870 
Noncurrent operating lease liability  172   269 
Term loan obligation  4,108   5,005 
Warrant liability     1 
Total liabilities  11,700   11,145 
Stockholders’ equity:      
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 1,952 shares
issued and outstanding at September 30, 2022 and December 31, 2021
Common stock, $0.001 par value; 100,000,000 shares authorized; 32,570,002
and 15,510,025 issued and outstanding at September 30, 2022 and December
31, 2021, respectively
  32   16 
Additional paid-in capital  472,899   457,730 
Accumulated deficit  (461,527)  (446,910)
Total stockholders’ equity  11,404   10,836 
Total liabilities and stockholders’ equity $23,104  $21,981 

(in thousands, except share and per share data)
  For the Three Months Ended
September 30,
  For the Nine Months Ended
September 30,
  2022  2021  2022  2021 
Grant revenue: $73  $  $73  $ 
Operating expenses:            
Research and development  2,945   1,491   7,560   3,724 
General and administrative  2,222   1,990   6,653   4,811 
Loss on disposal of property and equipment     18      18 
Total operating expenses  5,167   3,499   14,213   8,553 
Operating loss  (5,094)  (3,499)  (14,140)  (8,553)
Other income (expense):            
Interest income  48   5   74   13 
Interest expense  (173)  (232)  (552)  (708)
Change in fair value of liability instruments     2   1   4 
Total other expense  (125)  (225)  (477)  (691)
Net loss $(5,219) $(3,724) $(14,617) $(9,244)
Net loss per share, basic and diluted $(0.19) $(0.28) $(0.61) $(0.84)
Basic and diluted weighted average shares used in
calculating net loss per share attributable to common
  27,441,654   13,264,230   23,789,195   10,961,284 

(in thousands)
  For the Nine Months Ended September 30, 
  2022  2021 
Cash flows used in operating activities:      
Net loss $(14,617) $(9,244)
Adjustments to reconcile net loss to net cash used in operating activities:      
Depreciation and amortization  460   266 
Amortization of deferred financing costs and debt discount  309   417 
In process research and development acquired     18 
Change in fair value of liability instruments  (1)  (4)
Stock-based compensation expense  476   425 
Non-cash lease expense  (35)  36 
Increases in cash caused by changes in operating assets and liabilities:      
Grant receivable  73    
Other current assets  642   12 
Accounts payable and accrued expenses  1,955   418 
  Net cash used in operating activities  (10,738)  (7,656)
Cash flows used in investing activities:      
Purchases of property and equipment  (381)  (134)
Purchase of intangible assets  (117)   
Proceeds from sale of property and equipment     50 
In process research and development acquired  (250)   
  Net cash used in investing activities  (748)  (84)
Cash flows from financing activities:      
Principal payments of long-term obligations  (1,206)   
Payment of financing lease liability     (8)
Proceeds from exercise of warrants     2,017 
Proceeds from sale of common stock, net  14,558   18,665 
  Net cash provided by financing activities  13,352   20,674 
  Net increase in cash and cash equivalents  1,866   12,934 
Cash and cash equivalents at beginning of period  18,400   8,346 
Cash and cash equivalents at end of period $20,266  $21,280 
Supplemental disclosure of cash flows information:      
Cash paid during period for:      
Interest $248  $292 
Supplemental schedule of non-cash investing and financing activities:      
Unpaid offering cost $68  $139 
Right-of-use asset obtained in exchange for lease liabilities $  $81 

Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767

Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326