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Plus Therapeutics(PSTV) - 2024 Q1 - Quarterly Results
2024-05-15 20:01
Exhibit 99.1 Plus Therapeutics Reports First Quarter 2024 Financial Results and Recent Business Highlights Announced private placement of up to $19.25M with healthcare funds and insiders Received $3M award recommendation from the Department of Defense to support Plus' clinical brain cancer program Acquired synergistic leptomeningeal metastases diagnostic portfolio and announced related positive top-line FORESEE clinical trial data Management to Host Conference Call May 15, 2024 at 5:00 p.m. ET AUSTIN, Texas ...
Plus Therapeutics(PSTV) - 2024 Q1 - Quarterly Report
2024-05-15 20:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-34375 4200 MARATHON BLVD., SUITE 200, AUSTIN, TX 78756 (Address of principal executive offices) (Zip Code) (737) 255-7194 (Regis ...
Plus Therapeutics to Announce First Quarter Financial Results and Host Conference Call on May 15, 2024
Newsfilter· 2024-05-13 11:30
AUSTIN, Texas, May 13, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that the Company will report first quarter 2024 financial results on Wednesday, May 15, 2024, after market close. Plus Therapeutics' management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results ...
Plus Therapeutics(PSTV) - 2023 Q4 - Earnings Call Transcript
2024-03-06 00:07
Plus Therapeutics, Inc. (NASDAQ:PSTV) Q4 2023 Earnings Conference Call March 5, 2024 5:00 PM ET Company Participants Marc Hedrick - President and CEO Andrew Sims - CFO Norman LaFrance - CMO Conference Call Participants Justin Walsh - Jones Trading Sean Lee - H.C. Wainwright Edward Woo - Ascendiant Capital Operator Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Fourth Quarter and Full Year 2023 Results Conference Call. [Operator Instructions] Please be advised that today's conference ...
Plus Therapeutics(PSTV) - 2023 Q4 - Annual Report
2024-03-04 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-34375 PLUS THERAPEUTICS, INC. (Exact name of Registrant as Specified in Its Charter) DELAWARE 33-0827593 (State or Other Jurisdiction ...
Plus Therapeutics(PSTV) - 2023 Q4 - Annual Results
2024-03-04 16:00
Exhibit 99.1 Plus Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights Began enrollment of the 5 th of an anticipated 7 planned dosing cohorts for the ReSPECT-LM Phase 1 dose escalation trial with rhenium ( 186Re) obisbemeda for leptomeningeal metastases (LM) Reached agreement to expand ReSPECT-GBM Phase 2 trial and add new sites Current financial forecast for sufficient runway to fund operations into 2H 2025 Management to Host Conference Call March 5, 2024 at 5:0 ...
Plus Therapeutics(PSTV) - 2023 Q3 - Earnings Call Transcript
2023-10-31 23:46
Financial Data and Key Metrics Changes - As of September 30, 2023, cash and cash equivalents were $11 million, consistent with the balance at June 30, 2023 [16] - Net loss for Q3 2023 was $3.2 million or $1 per share, compared to a net loss of $5.2 million or $2.85 per share for the same period last year, indicating an improvement [18] - Total operating expenses for Q3 2023 decreased by $0.7 million to $4.5 million compared to $5.2 million for the same period last year, primarily due to the completion of CGMP drug development in 2022 [36] Business Line Data and Key Metrics Changes - The ReSPECT-GBM trial of Rhenium-186 Obisbemeda in recurrent glioblastoma (rGBM) is progressing, with a favorable safety profile and no dose-limiting toxicities reported across 34 patients [5][10] - In the Phase I trial, median overall survival for patients with absorbed doses greater than 100 gray was 70 weeks, compared to 22 weeks for those with doses less than 100 gray [25] - The ReSPECT-LM Phase I/IIa trial for leptomeningeal metastases (LM) is also advancing, with Cohort 4 being the fastest to enroll [27][29] Market Data and Key Metrics Changes - The company continues to receive interest in its CNS radiotherapeutic assets, attributed to a renewed interest in the radiotherapeutic space and the lack of approved treatments for LM and GBM [62] - The company has received a $3 million grant from the NIH to support the GBM trial through Phase II, expected to be fully utilized by the end of 2024 [35] Company Strategy and Development Direction - The company plans to complete enrollment in the Phase II ReSPECT-GBM trial and finalize pivotal trial design with the FDA [19] - The BAM radioembolic product will be regulated as a device, which is expected to reduce clinical requirements and approval timelines [33] - The company is focusing on expanding supply agreements and building supply chain redundancy, particularly regarding isotope availability [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing trials and the potential for accelerated approval for LM due to the lack of treatment options [48] - The FDA has requested additional information for both existing studies and the upcoming pediatric study, but management is confident in addressing these requests [64][65] - The company anticipates starting the Phase I ReSPECT pediatric brain cancer trial early next year, pending IND clearance from the FDA [53][57] Other Important Information - The company has successfully transferred proprietary materials and equipment from Biocept to utilize the CNSide assay for CSF tumor cell enumeration testing [13] - The company plans to implement the CNSide assay in the LM trial and is considering exercising an exclusivity option for the assay [51][52] Q&A Session Summary Question: What can be expected from the presentations at SNO? - The company will present updated imaging data and safety and efficacy data from the Phase II trial, with five abstracts accepted [41] Question: Will the speed of enrollment in Cohort 4 of the LM trial continue? - The company expects to maintain a similar enrollment rate and aims to complete the full dose escalation by June of next year [47] Question: What are the plans for implementing CNSide in the LM study after Biocept's bankruptcy? - The company has licensed the technology and will use it as a research tool in their trials, with plans to monitor the situation closely [71] Question: Will the additional funding cover the majority of Phase II study expenses? - Yes, the CPRIT funds will cover approximately two-thirds of all costs related to the study, making the grant very attractive [66] Question: Will the current cohort be the highest in the dose escalation study? - The company does not expect to reach a maximum tolerated dose but anticipates reaching a maximum feasible dose [67]
Plus Therapeutics(PSTV) - 2023 Q3 - Quarterly Report
2023-10-30 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 001-34375 PLUS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) DELAWARE 33-0827593 (State or other jurisdiction of incorporation or organization) 4200 MARATHON BLVD., SUITE 200, AUSTIN, TX 78756 (Address of principal executive offices) (Zip Code) For the quarterly period ended Se ...
Plus Therapeutics(PSTV) - 2023 Q2 - Earnings Call Transcript
2023-08-15 01:52
Plus Therapeutics, Inc. (NASDAQ:PSTV) Q2 2023 Earnings Conference Call August 14, 2023 5:00 PM ET Corporate Participants Marc Hedrick - President and Chief Executive Officer Andrew Sims - Chief Financial Officer Conference Call Participants Justin Walsh - Jones Trading Sean Lee - H.C. Wainwright Edward Woo - Ascendiant Capita Operator Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Second Quarter 2023 Results Conference Call. Before we begin, we want to advise you that over the course ...
Plus Therapeutics(PSTV) - 2023 Q2 - Quarterly Report
2023-08-13 16:00
[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This part details the company's unaudited financial statements and management's discussion and analysis [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed financial statements, including balance sheets, statements of operations, stockholders' equity, and cash flows, along with accompanying notes. It provides a snapshot of the company's financial position, performance, and cash movements for the periods ended June 30, 2023, and December 31, 2022 [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) This section summarizes the company's financial position, detailing assets, liabilities, and equity Condensed Balance Sheet Highlights (in thousands) | Metric | June 30, 2023 | December 31, 2022 | Change (2023 vs 2022) | | :-------------------------- | :-------------- | :---------------- | :-------------------- | | Cash and cash equivalents | $10,895 | $18,120 | $(7,225) | | Total current assets | $12,364 | $21,817 | $(9,453) | | Total assets | $14,197 | $23,867 | $(9,670) | | Total current liabilities | $11,399 | $11,852 | $(453) | | Total liabilities | $11,535 | $17,422 | $(5,887) | | Total stockholders' equity | $2,662 | $6,445 | $(3,783) | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) This section presents the company's financial performance, detailing revenues, expenses, and net loss Condensed Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :-------------------------------------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Development revenues: Government contracts and other | $1,854 | $— | $2,360 | $— | | Research and development expenses | $1,420 | $2,831 | $4,403 | $4,615 | | General and administrative expenses | $1,924 | $2,289 | $4,167 | $4,431 | | Total operating expenses | $3,344 | $5,120 | $8,570 | $9,046 | | Loss from operations | $(1,490) | $(5,120) | $(6,210) | $(9,046) | | Net loss | $(1,482) | $(5,282) | $(6,287) | $(9,398) | | Net loss per share, basic and diluted | $(0.59) | $(3.56) | $(2.60) | $(6.43) | [Condensed Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity) This section outlines changes in the company's equity accounts, including common stock, capital, and deficit Condensed Statements of Stockholders' Equity Highlights (in thousands, except share data) | Metric | December 31, 2022 | June 30, 2023 | | :-------------------------- | :---------------- | :------------ | | Common stock shares | 2,240,092 | 2,879,620 | | Common stock amount | $2 | $3 | | Additional paid-in capital | $473,628 | $476,131 | | Accumulated deficit | $(467,185) | $(473,472) | | Total stockholders' equity | $6,445 | $2,662 | [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This section details cash inflows and outflows from operating, investing, and financing activities Condensed Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(8,571) | $(6,516) | | Net cash used in investing activities | $(108) | $(715) | | Net cash provided by financing activities | $1,454 | $6,921 | | Net decrease in cash and cash equivalents | $(7,225) | $(310) | | Cash and cash equivalents at end of period | $10,895 | $18,090 | [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) This section provides detailed explanations and additional information for the condensed financial statements [1. Basis of Presentation and New Accounting Standards](index=8&type=section&id=1.%20Basis%20of%20Presentation%20and%20New%20Accounting%20Standards) This note outlines the basis for preparing the unaudited condensed financial statements, the impact of a reverse stock split, the company's policy for grant revenue recognition, and the adoption of new accounting guidance for credit losses - The Company implemented a **1-for-15 reverse stock split** effective May 1, 2023, decreasing outstanding common stock from approximately **37.4 million to 2.5 million shares**[24](index=24&type=chunk)[25](index=25&type=chunk) - Government grants are recognized as revenue when related expenses are incurred, applying IAS 20 by analogy, as funding entities are not considered 'customers' under ASC 606[26](index=26&type=chunk)[27](index=27&type=chunk) - The Company adopted ASU 2016-13 (Credit Losses) as of January 1, 2023, which did not materially impact its financial statements[29](index=29&type=chunk) [2. Use of Estimates](index=9&type=section&id=2.%20Use%20of%20Estimates) This note highlights that the preparation of financial statements requires management to make significant estimates and assumptions, particularly concerning grant revenue recognition, asset impairment, and stock-based compensation - Significant estimates and critical accounting policies include grant revenue recognition, reviewing assets for impairment, and determining assumptions for stock-based compensation expense[30](index=30&type=chunk) [3. Liquidity and Going Concern](index=9&type=section&id=3.%20Liquidity%20and%20Going%20Concern) The company's accumulated deficit, net loss, and cash used in operations raise substantial doubt about its ability to continue as a going concern, necessitating additional capital to fund future operations - The Company incurred a net loss of **$(6.3) million** and used **$(8.6) million** in cash from operations for the six months ended June 30, 2023, with an accumulated deficit of **$473.5 million**, raising substantial doubt about its ability to continue as a going concern[31](index=31&type=chunk) - The Company regained compliance with Nasdaq's Minimum Bid Requirement after a **1-for-15 reverse stock split** effective May 1, 2023[35](index=35&type=chunk) - Ongoing need to raise additional cash from outside sources to fund future clinical development programs and operations; inability to do so would materially and adversely impact operations and could lead to default on its term loan[32](index=32&type=chunk)[36](index=36&type=chunk)[37](index=37&type=chunk) [4. Fair Value Measurements](index=10&type=section&id=4.%20Fair%20Value%20Measurements) This note describes the company's fair value measurement hierarchy and the classification of Series U Warrants as Level 3 liability instruments, with immaterial changes in fair value - Series U Warrants are classified as **Level 3 liability instruments** and are marked to market each balance sheet date, with changes in fair value recorded as non-operating income or loss[39](index=39&type=chunk)[40](index=40&type=chunk) [5. Term Loan Obligations](index=10&type=section&id=5.%20Term%20Loan%20Obligations) Details of the term loan with Oxford Finance, LLC, including its original amount, interest rate, amendments, collateral, and the company's compliance with debt covenants - The Company has a Term Loan with Oxford Finance, LLC, with **$2.0 million** principal outstanding as of June 30, 2023, excluding a **$3.2 million** final payment fee, maturing June 1, 2024[41](index=41&type=chunk)[44](index=44&type=chunk) - The Term Loan is collateralized by substantially all of the Company's assets, including intellectual property, and the Company was in compliance with all debt covenants as of June 30, 2023[44](index=44&type=chunk) Interest Expense (in thousands) | Period | 2023 | 2022 | | :-------------------------------- | :--- | :--- | | Three Months Ended June 30, | $112 | $181 | | Six Months Ended June 30, | $246 | $379 | [6. Loss per Share](index=11&type=section&id=6.%20Loss%20per%20Share) This note explains the calculation of basic and diluted loss per