GlobeNewswire Inc | Oct 22, 2020 04:05PM EDT

October 22, 2020

ReceivedFDA Orphan Drug and Fast Track designations for novel glioblastoma radiotherapy

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

AUSTIN, Texas, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq:PSTV) (the Company), today announced financial results for the third quarter ended September 30, 2020, and provided an overview of recent business highlights.

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 Companys 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 Companys 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 2020 FinancialResults

-- 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 andWebcastDate: Thursday, October 22, 2020Time: 5:00 p.m. Eastern Time.Live 877-402-3914; 631-865-5294 (Intl.); Conference ID: 2108916Call:

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 Companys belief as to the platforms capacity to leverage new delivery approaches and/or formulations to enable significant potential enhancements of safety, efficacy and convenience for patients and healthcare providers; the potential of the Companys portfolio generally, and the potential of RNL to safely and effectively deliver a dose of radiation directly to the tumor up to 25 times greater than that currently being given to patients using external beam radiation therapy; the Companys belief as to the potential of RNL to improve brain tumor therapy and that of other difficult to treat radiosensitive tumors; the timing, status, outcome, and anticipated expansion of clinical trials for RNL, including the planned initiation of an additional Phase 1 study and enrollment at additional sites, and the anticipated timing thereof; the Companys business expansion outlook for the second half of 2020, including its intended focus on certain additional business expansion milestones; the Companys expectations regarding the progress and prospect of advancement for the Company, RNL, and the Companys portfolio during the second half of 2020; and the potential impact of the COVID-19 pandemic on the Company and its clinical programs, operating results, and financial condition. 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 CONDENSED BALANCE SHEETS (UNAUDITED)(in thousands, except share and par value data) AsofSeptember AsofDecember31, 30, 2019 2020Assets Current assets: Cash and cash equivalents $ 7,626 $ 17,552 Accounts receivable ? 1,169 Restricted cash ? 40 Inventories, net 107 107 Other current assets 916 957 Total current assets 8,649 19,825 Property and equipment, net 1,943 2,179 Operating lease right-of-use assets 671 781 Other assets 18 72 Goodwill 372 372 Total assets $ 11,653 $ 23,229 Liabilities and Stockholders? Equity Current liabilities: Accounts payable and accrued $ 2,083 $ 3,279 expensesOperating lease liability 140 147 Term loan obligations, net of 6,181 11,060 discountTotal current liabilities 8,404 14,486 Noncurrent operating lease liability 545 646 Warrant liability 83 6,929 Other noncurrent liabilities ? 8 Total liabilities 9,032 22,069 Commitments and contingencies (Note 9) Stockholders? equity: Preferred stock, $0.001 par value;5,000,000 shares authorized; 1,954and 1,959 shares issued and ? ? outstanding at September 30, 2020and December 31, 2019, respectivelyCommon stock, $0.001 par value;100,000,000 shares authorized;4,591,415 and 3,880,588 shares 5 4 issued and outstanding at September30, 2020 and December 31, 2019,respectivelyAdditional paid-in capital 432,540 426,426 Accumulated deficit (429,924 ) (425,270 )Total stockholders? equity 2,621 1,160 Total liabilities and stockholders? $ 11,653 $ 23,229 equity

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

For the Three Months For the Nine Months Ended Ended September30, September30, 2020 2019 2020 2019 Development revenues:Government $ ? $ 4,771 $ 303 $ 5,810 contracts and otherOperating expenses: Research and 336 921 1,604 3,636 developmentIn process researchand development ? ? 781 ? acquired fromNanoTxSales and marketing 104 94 319 305 General and 956 1,076 3,788 3,313 administrative Total operating 1,396 2,091 6,492 7,254 expenses Operating income (1,396 ) 2,680 (6,189 ) (1,444 )(loss) Other income (expense):Interest income 2 6 47 20 Interest expense (253 ) (366 ) (854 ) (1,477 )Change in fair (81 ) (561 ) 2,342 (69 )value of warrantsWarrant issuance ? (1,233 ) ? (1,233 )cost Total other (332 ) (2,154 ) 1,535 (2,759 )income (expense)Income (Loss) fromcontinuing (1,728 ) 526 (4,654 ) (4,203 )operationsLoss fromdiscontinued ? ? ? (7,568 )operationsNet income (loss) $ (1,728 ) $ 526 $ (4,654 ) $ (11,771 ) Income (Loss) fromcontinuing $ (1,728 ) $ 526 $ (4,654 ) $ (4,203 )operationsBeneficialconversion feature ? (554 ) ? $ (554 )for convertiblepreferred stockNet loss allocableto commonstockholders - $ (1,728 ) $ (28 ) $ (4,654 ) $ (4,757 )continuingoperationsNet loss allocableto commonstockholders - $ ? $ ? $ ? $ (7,568 )discontinuedoperations Basic and dilutednet loss per shareattributable to $ (0.39 ) $ (0.03 ) $ (1.13 ) $ (8.78 )common stockholders- continuingoperationsBasic and dilutednet loss per shareattributable to $ ? $ ? $ ? $ (13.97 )common stockholders- discontinuedoperationsNet loss per share, $ (0.39 ) $ (0.03 ) $ (1.13 ) $ (22.75 )basic and dilutedBasic and dilutedweighted averageshares used incalculating net 4,402,221 826,548 4,113,928 541,777 loss per shareattributable tocommon stockholders

PLUS THERAPEUTICS, INC.CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)(in thousands) For the Nine Months Ended September30, 2020 2019 Cash flows used in operating activities: Net loss $ (4,654 ) $ (11,771 )Adjustments to reconcile net loss to net cash used in operating activities:Depreciation and amortization 273 778 Amortization of deferred financing costs and debt 428 354 discountIn process research and development acquired from 781 ? NanoTx TherapeuticsNoncash lease expenses 2 22 Change in fair value of warrants (2,342 ) 69 Share-based compensation expense 149 106 Loss on sale of business ? 6,508 Allocation of issuance costs associated with ? 1,233 warrantsIncreases (decreases) in cash caused by changes in operating assets and liabilities:Accounts receivable 1,169 (4,851 )Inventories ? 274 Other current assets 516 252 Other assets 54 298 Accounts payable and accrued expenses (1,586 ) (297 )Deferred revenues ? 29 Other long-term liabilities ? 54 Net cash used in operating activities (5,210 ) (6,942 )Cash flows provided by (used in) investing activities:Purchases of property and equipment (37 ) (8 )In process research and development acquired from (400 ) ? NanoTx TherapeuticsProceeds from sale of business ? 5,637 Net cash provided by (used in) investing (437 ) 5,629 activitiesCash flows used in financing activities: Principal payments of long-term obligations (5,307 ) (3,490 )Payment of financing lease liability (93 ) (75 )Proceeds from exercise of warrants 1,081 491 Proceeds from sale of common stock, net ? 15,964 Net cash provided by (used in) financing (4,319 ) 12,890 activities Effect of exchange rate changes on cash and cash ? (4 )equivalents Net increase (decrease) in cash and cash (9,966 ) 11,573 equivalentsCash, cash equivalents, and restricted cash at 17,592 5,301 beginning of periodCash, cash equivalents, and restricted cash at end 7,626 16,874 of periodSupplemental disclosure of cash flows information: Cash paid during period for: Interest $ 470 $ 1,071 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 developmentOffering cost paid in warrants $ ? $ 213 Unpaid offering costs $ 12 $ 403

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

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