GlobeNewswire Inc | Feb 22, 2021 04:05PM EST

February 22, 2021

Positive interim data through cohort five for the ReSPECT Phase 1 clinical trial in recurrent glioblastoma, announced November 2020

Completed sixth dosing cohort in ReSPECT December 2020

Management to host conference call today, Monday, February 22nd, at 5:00 p.m. ET

AUSTIN, Texas, Feb. 22, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq:PSTV) (the Company), a clinical-stage pharmaceutical company developing novel, targeted therapies for rare and difficult to treat cancers, today announced financial results for the fourth quarter and full year ended December 31, 2020, and provided an overview of recent business highlights.

In the second quarter of 2020, we in-licensed a promising new radiotherapeutic platform and portfolio of investigational drugs, then made substantial clinical progress for the lead compound and also moved additional opportunities closer to clinical phase, said Marc Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. In 2021, we intend to make even greater progress advancing our CNS oncology portfolio through the development process and bringing it closer to a potential registrational clinical trial read out.

Rhenium NanoLiposome (RNL) Program - Background and 2020 Highlights

The Companys lead investigational drug is RNL, a radiotherapy in development for several rare cancer targets, including recurrent glioblastoma (GBM) in the U.S. multi-center ReSPECT Phase 1 dose-finding trial. RNL is designed to safely, effectively, and conveniently deliver a very high dose of radiation directly into the brain tumor compared to traditional external beam radiation therapy (EBRT). 2020 highlights for RNL include:

-- ReSPECT trial of RNL for recurrent glioblastoma supported by a multi-phase and multi-year financial grant from the U.S. National Institutes of Health/National Cancer Institute (NIH/NCI). -- RNL received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of GBM. -- Presented positive interim data from the first 15 patients, through Cohort 5, in the ReSPECT trial at the 2020 Society for Neuro-Oncology Annual Meeting (SNO 2020 E-poster). -- Completed the 6th dose escalation cohort, with 18 total patients treated in ReSPECT, with increases in both the RNL drug volume and radiation dose. -- Thus far, RNL can be successfully delivered with up to 15 times the absorbed dose of radiation administered by standard EBRT without significant toxicity. -- ReSPECT clinical trial expanded to two additional locations. -- Established Clinical Advisory and Scientific Advisory Boards with leading experts in the fields of neurosurgery, neuro-oncology, preclinical drug development, and nanotechnology.

Expected Upcoming Milestones and Events

In upcoming quarters, the Company intends to focus on a number of additional business objectives and potential milestones:

-- Complete enrollment of the ReSPECT Phase 1 trial for RNL in recurrent glioblastoma. -- Complete pivotal trial planning with FDA for RNL in recurrent glioblastoma. -- Complete pre-IND meeting with the FDA, execute IND-enabling studies, if needed, and move into clinical trials for follow-on RNL indications, leptomeningeal metastases and pediatric brain cancer. -- Continue development and evaluation of additional external and internal drug development candidates to expand the pipeline. -- Continue partnership discussions for three clinical-stage injectable drugs: RNL, DocePLUS, and generic DoxoPLUS.

Fourth Quarter 2020 Financial Results

-- As of December 31, 2020, the Companys cash balance was $8.3 million, compared to $17.6 million as of December 31, 2019. -- Net cash used in operating activities was $8.4 million for the year ended December 31, 2020, compared to net cash used in operating activities of $5.9 million during the same period in 2019. -- During the second quarter of 2020, $5.0 million of the Oxford debt principal was paid down to a current principal balance of $4.3 million at December 31, 2020. -- Net loss for full year 2020 was $8.2 million, or $(1.86) per share, compared to a net loss of $11.4 million, or $(8.27) per share (on a fully diluted basis including preferred stock), for full year 2019.

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 Fourth Quarter and Full Year 2020 Financial Results Conference Call and WebcastDate: Monday, February 22, 2021Time: 5:00 p.m. Eastern TimeLive 877-402-3914 (toll free); 631-865-5294 (Intl.); Conference ID: 6206747Call:

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.

About Plus Therapeutics, Inc.

Plus Therapeutics (Nasdaq: PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Companys drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The 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 atwww.PlusTherapeutics.com and www.respect-trials.com.

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 will, believe, plan, can, enable, design, intend, potential, expect, estimate, project, prospect, target, focus, anticipate, could, should, 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 design and potential of the Plus Therapeutics portfolio to reformulate, deliver and commercialize multiple novel, proprietary drugs targeting rare cancers and other diseases and to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs; the potential of the Companys new, in-licensed portfolio of investigational drugs; the Companys intent to advance its CNS oncology portfolio through the clinical development process; the ability of RNL to safely, effectively and conveniently deliver a very high dose of radiation greater than traditional EBRT directly into the brain tumor; and the Companys anticipated milestones and events, including with respect to enrollment, pivotal trial planning, IND process, and clinical phase plans for RNL, pipeline expansion through additional drug development candidates, and partnership discussions for RNL, DocePLUS and DoxoPLUS. 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 risk that the Company is not able to successfully develop product candidates that can leverage the U.S. FDAs accelerated regulatory pathways; the early stage of the Companys product candidates and therapies, the results of its research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Companys history of losses; the Companys need for, and ability to raise, additional cash or obtain other sources of funding in the immediate future; the Companys ability to: (a) obtain and maintain regulatory approvals, (b) continue as a going concern, (c) remain listed on the Nasdaq Capital Market, (d) to obtain or maintain sufficient levels of reimbursement for its tests, and (d) to repay or refinance some or all of its outstanding indebtedness; the outcome of the Companys partnering/licensing efforts; market and economic conditions; the impact of the COVID-19 pandemic on the Company and the effectiveness of the efforts it has taken or may take in the future in response thereto; and additional risks described under the heading Risk Factors in the Companys Securities and Exchange Commission filings, including in the Companys 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.

PLUS THERAPEUTICS, INC.CONSOLIDATED BALANCE SHEETS(in thousands, except share and par value data)

As of December 31, 2020 2019 Assets Current assets: Cash and cash equivalents $ 8,346 $ 17,552 Accounts receivable ? 1,169 Restricted cash ? 40 Inventories, net ? 107 Other current assets 829 957 Total current assets 9,175 19,825 Property and equipment, net 1,820 2,179 Operating lease right-use-of assets 636 781 Goodwill 372 372 Intangible assets, net 86 ? Other assets 16 72 Total assets $ 12,105 $ 23,229 Liabilities and Stockholders? Equity Current liabilities: Accounts payable and accrued expenses $ 2,081 $ 3,279 Operating lease liability 123 147 Term loan obligation, net of discount 6,335 11,060 Total current liabilities 8,539 14,486 Noncurrent operating lease liability 528 646 Warrant liability 7 6,929 Other noncurrent liabilities ? 8 Total liabilities 9,074 22,069 Commitments and contingencies Stockholders? equity: Preferred stock, $0.001 par value; 5,000,000shares authorized; 1,954 and 1,959 shares issued ? ? and outstanding in 2020 and 2019, respectivelyCommon stock, $0.001 par value; 100,000,000shares authorized; 6,749,028 and 3,880,588 shares 7 4 issued and outstanding in 2020 and 2019,respectivelyAdditional paid-in capital 436,535 426,426 Accumulated deficit (433,511 ) (425,270 )Total stockholders? equity 3,031 1,160 Total liabilities and stockholders? equity $ 12,105 $ 23,229

PLUS THERAPEUTICS, INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(in thousands, except share and per share data)

For the Years Ended December 31, 2020 2019 Development revenue: Government contracts and other $ 303 $ 6,998 303 6,998 Operating expenses: Research and development 2,700 5,365 In process research and development acquired 781 ? from NanoTxGeneral and administrative 6,406 5,290 Total operating expenses 9,887 10,655 Operating loss (9,584 ) (3,657 ) Other income (expense): Interest income 50 55 Interest expense (1,107 ) (1,855 )Change in fair value of liability instruments 2,400 3,407 Issuance cost of warrants ? (1,233 )Total other expense 1,343 374 Loss from continuing operations $ (8,241 ) $ (3,283 )Loss from discontinued operations ? (7,604 )Net loss $ (8,241 ) $ (10,887 ) Loss from continuing operations $ (8,241 ) $ (3,283 )Beneficial conversion feature for convertible ? (554 )preferred stockNet loss allocable to common stockholders - $ (8,241 ) $ (3,837 )continuing operationsNet loss allocable to common stockholders - - (7,604 )discontinued operationsNet loss allocable to common stockholders $ (8,241 ) $ (11,441 )Basic and diluted net loss per shareattributable to common stockholders ? $ (1.86 ) $ (2.77 )continuing operationsBasic and diluted net loss per shareattributable to common stockholders - - (5.49 )discontinued operationsNet loss per share, basic and diluted $ (1.86 ) $ (8.27 ) Basic and diluted weighted average shares usedin calculating net loss per share 4,427,835 1,384,012 attributable to common stockholders

PLUS THERAPEUTICS, INC.CONSOLIDATED STATEMENTS OF CASH FLOWS(in thousands)

For the Years Ended December 31, 2020 2019 Cash flows used in operating activities: Net loss $ (8,241 ) $ (10,887 )Adjustments to reconcile net loss to net cash used in operating activities:Depreciation and amortization 366 896 Amortization of deferred financing costs and debt 584 550 discountIn process research and development acquired from 781 ? NanoTx TherapeuticsChange in fair value of liability instruments (2,400 ) (3,407 )Share-based compensation expense 247 127 Inventory write off 107 ? Noncash lease expense 3 12 Loss on sale of business ? 6,508 Allocation of issuance cost associated with warrants ? 1,233 Increases (decreases) in cash caused by changes in operating assets and liabilities:Accounts receivable 1,169 (1,203 )Inventories ? 259 Other current assets 126 (211 )Other assets 58 263 Accounts payable and accrued expenses (1,234 ) (28 )Deferred revenue ? 29 Other long-term liabilities ? (47 )Net cash used in operating activities (8,434 ) (5,906 ) Cash flows from (used in) investing activities: Purchases of property and equipment (93 ) (67 )In process research and development acquired from (400 ) ? NanoTx TherapeuticsProceeds from sale of business ? 5,637 Net cash provided by (used in) investing activities (493 ) 5,570 Cash flows from financing activities: Principal payments of long-term obligations (5,307 ) (3,692 )Payment of financing lease liability (117 ) (131 )Proceeds from exercise of warrants 1,098 490 Proceeds from sale of common stock 4,007 15,964 Net cash (used in) provided by financing activities (319 ) 12,631 Effect of exchange rate changes on cash and cash ? (4 )equivalentsNet increase (decrease) in cash and cash equivalents (9,246 ) 12,291 Cash, cash equivalents, and restricted cash at 17,592 5,301 beginning of periodCash, cash equivalents, and restricted cash at end $ 8,346 $ 17,592 of period Supplemental disclosure of cash flows information: Cash paid during period for: Interest $ 567 $ 1,188 Supplemental schedule of non-cash investing and financing activities:Issuance costs paid in common stock $ 463 $ ? Common stock issued in payment for in process $ 381 $ ? research and developmentUnpaid offering cost $ 125 $ ? Proceeds from sales of business, net, paid directlyto lender for principal payment of long-term $ ? $ 3,050 obligationsOffering cost paid in warrants $ ? $ 213 Reclassification of warrants upon exercise from $ 4,504 $ 794 liability to equityFair value of Convertible Preferred Stock beneficial $ ? $ 554 conversion feature

Investor ContactPeter VozzoWestwicke/ICR(443) 377-4767 Peter.Vozzo@westwicke.com

Media ContactTerri ClevengerWestwicke/ICR(203) 856-4326Terri.Clevenger@westwicke.com