UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
Current Report
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Securities registered pursuant to Section 12(b) of the Act:
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The |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On April 21, 2022, Plus Therapeutics, Inc. (the “Company”) reported financial results for the quarter ended March 31, 2022 and other recent corporate updates. A copy of the press release is furnished as Exhibit 99.1 to this report and incorporated by reference.
The information in this Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information shall not be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, whether made before or after today’s date, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific references in such filing.
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Item 9.01 |
Financial Statements and Exhibits. |
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(d) Exhibits. |
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Exhibit |
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Description |
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99.1 |
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Press Release Announcing Financial Results, dated April 21, 2022. |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: April 21, 2022
PLUS THERAPEUTICS, INC.
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By: |
/s/ Marc H. Hedrick, M.D. |
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Marc H. Hedrick, M.D. President and Chief Executive Office |
Exhibit 99.1
Plus Therapeutics Reports First Quarter 2022 Financial Results and Business Highlights
First patient dosed in ReSPECT-LM Phase 1/2a dose escalation trial of 186RNL for leptomeningeal metastases
Closed in licensing transaction for novel targeted radioembolic technology for the treatment of solid organ tumors
Expanded ReSPECT-GBM clinical trial partnership with Medidata to design innovative registrational trial of 186RNL for recurrent glioblastoma
Management to host conference call today at 5:00 p.m. ET
AUSTIN, Texas, April 21, 2022 – 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 first quarter ended March 31, 2022, and provided an overview of recent business highlights.
“In the first quarter of 2022, we announced a major corporate milestone, specifically the successful enrollment of the first patient in our ReSPECT-LM Phase 1/2a dose escalation trial of 186RNL in patients with leptomeningeal metastases,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “This adds a very important new clinical program to our growing drug development pipeline targeting significant unmet medical conditions.”
RECENT HIGHLIGHTS
Rhenium-186 NanoLiposome (186RNL), a novel radiotherapy in development for several rare cancer targets
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▪ |
Treated first patient in the ReSPECT-LM Phase 1/2a dose escalation trial of 186RNL in patients with leptomeningeal metastases (LM). |
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▪ |
Finalized key 186RNL drug product development and characterization activities for GMP manufacturing to support planned Phase 2 registrational clinical trial and commercialization of 186RNL in recurrent glioblastoma (GBM). |
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▪ |
Expanded partnership with Medidata Solutions, Inc., a Dassault Systèmes company, utilizing Medidata’s Synthetic Control Arm® (SCA) platform intended to speed enrollment, improve patient access and reduce clinical trial costs in Plus Therapeutics’ planned Phase 2 registrational trial of 186RNL in GBM. |
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▪ |
Presentation at the American Association for Cancer Research (AACR) 2022 Annual Meeting describing a biology-based, mathematical model to predict response of recurrent GBM to 186RNL treatment. |
Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere (188RNL-BAM), a novel
radiotherapy in development for solid organ cancers
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▪ |
Announced the in-licensing of a novel targeted radioembolic technology for the treatment of solid organ tumors and biodegradable alginate microspheres (BAM) technology for both diagnostic and/or therapeutic payloads. |
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▪ |
The Company began developing 188RNL-BAM as a next-generation radioembolization therapy for rare solid organ cancers including liver cancer. |
First Quarter 2022 FINANCIAL RESULTS
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▪ |
The Company’s cash balance was $21.2 million at March 31, 2022, compared to $18.4 million at December 31, 2021. |
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▪ |
Total operating expenses for the first quarter 2022 were $3.9 million, compared to total operating expenses of $2.5 million for first quarter 2021. Approximately $0.7 million of this increase is due to research and development expenses and $0.7 million to legal, intellectual property and professional fees. |
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▪ |
Net loss for the first quarter of 2022 was $4.1 million, or $(0.19) per share, compared to a net loss of $2.7 million, or $(0.33) per share, for the first quarter of 2021. |
UPCOMING EVENTS AND MILESTONES
During the remainder of 2022, the Company expects to accomplish the following key business objectives:
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▪ |
Upon U.S. Food and Drug Administration (FDA) approval, initiate a Phase 2/registrational trial in patients with recurrent GBM. |
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▪ |
Complete FDA CMC and clinical meetings for 186RNL. |
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▪ |
Manufacture GMP 186RNL for Phase 2 registrational trials. |
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▪ |
Obtain FDA approval for ReSPECT-GBM multiple dosing clinical trial arm. |
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Complete initial safety cohort in ReSPECT-LM Phase 1/2a dose escalation trial. |
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Obtain FDA approval for study of 186RNL in patients with pediatric brain cancer (ReSPECT-PBC). |
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▪ |
Complete technology transfer and key CMC, FDA IND-enabling studies for 188RNL-BAM. |
First 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.
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Event: |
Plus Therapeutics First Quarter 2022 Results Conference Call |
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Date: |
April 21, 2022 |
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Time: |
5:00 p.m. Eastern Time |
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Live Call: |
866-342-8591 (toll free); 203-518-9713 (Intl.); Conference ID: PSTVQ122 |
The webcast can be accessed live via the Investor Relations 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 is a clinical-stage pharmaceutical company focused on developing innovative, targeted radiotherapeutics for adults and children worldwide with rare and difficult-to-treat cancers. Our proprietary radiotherapeutic platform uniquely uses nanoliposomes to encapsulate and deliver the radioisotope, Rhenium, into or near a tumor via a single, direct infusion. The lead radiotherapeutic in our pipeline, Rhenium-186 NanoLiposome (186RNL), is being evaluated in U.S. multi-center clinical trials for the treatment of recurrent glioblastoma and leptomeningeal metastases. More information may be found at PlusTherapeutics.com and 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 “designed to,” “will,” “plan,” “can,” “design,” “intend,” “potential,” “expect,” “target,” “focus,” 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 Company’s anticipated expenditures, including research and development, and general and administrative expenses; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approvals and interactions and government regulation; the potential size of the market for the Company’s product candidates; the Company’s research and development efforts; results from the Company’s pre-clinical and clinical studies and implications of such results regarding the efficacy or safety of the Company’s product candidates; the safety profile, pathways, and efficacy of the Company’s product candidates and formulations; anticipated advantages of the Company’s product candidates over other products available in the market and being developed; the populations that will most benefit from the Company’s product candidates and indications that will be pursued with each product candidate; anticipated progress in the Company’s current and future clinical trials; plans and strategies to create novel technologies; the Company’s IP strategy; competition; future development and/or expansion of the Company’s product candidates and therapies in its markets; sources of competition for any of the Company’s product candidates; the Company’s pipeline; the Company’s ability to generate product or development revenue and the sources of such revenue; the Company’s ability to effectively manage its gross profit margins; the Company’s ability to obtain and maintain regulatory approvals; expectations as to its future performance; portions of the “Liquidity and Capital Resources” section of its quarterly report for the period ended March 31, 2022, including its potential need for additional financing and the availability thereof; the Company’s ability to continue as a going concern; its ability to remain listed on the Nasdaq Capital Market; the Company’s ability to repay or refinance some or all of its outstanding indebtedness and its ability to raise capital in the future; the
Company’s ability to transfer the drug product manufacture to a contract drug manufacturing organization; and the potential enhancement of its cash position through development, marketing, and licensing arrangements.
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 regenerative medicine 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.
PLUS THERAPEUTICS, INC.
CONSOLIDATED CONDENSED BALANCE SHEETS
(UNAUDITED)
(in thousands, except share and par value data)
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March 31, 2022 |
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December 31, 2021 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
21,239 |
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$ |
18,400 |
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Other current assets |
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865 |
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1,324 |
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Total current assets |
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22,104 |
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19,724 |
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Property and equipment, net |
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1,558 |
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1,477 |
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Operating lease right-use-of assets |
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316 |
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341 |
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Goodwill |
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372 |
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372 |
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Intangible assets, net |
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150 |
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51 |
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Other assets |
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16 |
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16 |
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Total assets |
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$ |
24,516 |
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$ |
21,981 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable and accrued expenses |
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$ |
3,203 |
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$ |
4,151 |
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Operating lease liability |
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110 |
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111 |
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Term loan obligation, current |
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1,608 |
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1,608 |
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Total current liabilities |
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4,921 |
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5,870 |
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Noncurrent operating lease liability |
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235 |
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269 |
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Term loan obligation |
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4,718 |
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5,005 |
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Warrant liability |
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— |
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1 |
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Total liabilities |
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9,874 |
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11,145 |
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Stockholders’ equity: |
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Preferred stock, $0.001 par value; 5,000,000 shares authorized; 1,952 shares issued and outstanding at March 31, 2022 and December 31, 2021 |
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— |
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— |
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Common stock, $0.001 par value; 100,000,000 shares authorized; 22,197,635 and 15,510,025 issued and outstanding at March 31, 2022 and December 31, 2021, respectively |
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22 |
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16 |
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Additional paid-in capital |
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465,646 |
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457,730 |
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Accumulated deficit |
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(451,026 |
) |
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(446,910 |
) |
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Total stockholders’ equity |
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14,642 |
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10,836 |
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Total liabilities and stockholders’ equity |
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$ |
24,516 |
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$ |
21,981 |
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PLUS THERAPEUTICS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(UNAUDITED)
(in thousands, except share and per share data)
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For the Three Months Ended March 31, |
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2022 |
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2021 |
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Operating expenses: |
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Research and development |
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$ |
1,785 |
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$ |
1,127 |
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General and administrative |
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2,141 |
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1,352 |
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Total operating expenses |
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3,926 |
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2,479 |
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Operating loss |
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(3,926 |
) |
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(2,479 |
) |
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Other income (expense): |
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Interest income |
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7 |
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4 |
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Interest expense |
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(198 |
) |
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(247 |
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Change in fair value of liability instruments |
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1 |
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2 |
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Total other expense |
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(190 |
) |
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(241 |
) |
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Net loss |
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$ |
(4,116 |
) |
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$ |
(2,720 |
) |
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Net loss per share, basic and diluted |
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$ |
(0.19 |
) |
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$ |
(0.33 |
) |
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Basic and diluted weighted average shares used in calculating net loss per share attributable to common stockholders |
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21,507,061 |
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8,267,901 |
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PLUS THERAPEUTICS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(in thousands)
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For the Three Months Ended March 31, |
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2022 |
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2021 |
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Cash flows used in operating activities: |
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Net loss |
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$ |
(4,116 |
) |
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$ |
(2,720 |
) |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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147 |
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|
88 |
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Amortization of deferred financing costs and debt discount |
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115 |
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151 |
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Change in fair value of liability instruments |
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(1 |
) |
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(2 |
) |
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Share-based compensation expense |
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180 |
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107 |
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Non-cash lease expense |
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(10 |
) |
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1 |
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Increases (decreases) in cash caused by changes in operating assets and liabilities: |
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Other current assets |
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459 |
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(170 |
) |
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Accounts payable and accrued expenses |
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(650 |
) |
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(461 |
) |
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Net cash used in operating activities |
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(3,876 |
) |
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(3,006 |
) |
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Cash flows used in investing activities: |
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Purchases of property and equipment |
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(210 |
) |
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(84 |
) |
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Purchase of intangible assets |
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(117 |
) |
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— |
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In process research and development acquired |
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(250 |
) |
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— |
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Net cash used in investing activities |
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(577 |
) |
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(84 |
) |
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Cash flows from financing activities: |
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Principal payments of long-term obligations |
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(402 |
) |
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— |
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Payment of financing lease liability |
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— |
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(6 |
) |
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Proceeds from exercise of warrants |
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|
— |
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2,017 |
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Proceeds from sale of common stock |
|
|
7,694 |
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|
|
7,180 |
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Net cash provided by financing activities |
|
|
7,292 |
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|
|
9,191 |
|
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Net increase in cash and cash equivalents |
|
|
2,839 |
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|
|
6,101 |
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Cash and cash equivalents at beginning of period |
|
|
18,400 |
|
|
|
8,346 |
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|
Cash and cash equivalents at end of period |
|
$ |
21,239 |
|
|
$ |
14,447 |
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|
|
|
|
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|
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Supplemental disclosure of cash flows information: |
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Cash paid during period for: |
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|
|
|
|
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|
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Interest |
|
$ |
87 |
|
|
$ |
96 |
|
|
Supplemental schedule of non-cash investing and financing activities: |
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|
|
|
|
|
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|
|
Unpaid offering cost |
|
$ |
171 |
|
|
$ |
102 |
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Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
Terri.Clevenger@westwicke.com