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 ...

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 ...

Table of Contents As filed with the Securities and Exchange Commission on March 8, 2024 Registration No. 333-275712 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO Form S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 PLUS THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 33-0827593 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer ...

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 ...

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 ...

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 ...

Table of Contents As filed with the Securities and Exchange Commission November 22, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Exact name of Registrant as specified in its charter) Delaware 2834 33-0827593 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial (I.R.S. Employer Identification Number) 4200 Marathon Blvd., Suite 200 Austin, TX 78756 (737)-255-7194 (Address, including zip code, and telephone number, in ...

Table of Contents As filed with the Securities and Exchange Commission November 14, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 PLUS THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 33-0827593 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) ...

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]

Drug Development and Clinical Trials - Plus Therapeutics, Inc. is developing rhenium (186Re) obisbemeda, a targeted radiotherapeutic for CNS cancers, with the potential to deliver radiation doses up to 20 times greater than traditional external beam radiation therapy (EBRT) [113]. - The ongoing Phase 1/2a ReSPECT-GBM trial has shown the ability to deliver up to 740 Gy of absorbed radiation to tumor tissue without significant toxicities, compared to the typical maximum dose of 30-35 Gray in EBRT [116]. - The FDA has granted Orphan Drug and Fast Track designations to rhenium (186Re) obisbemeda for recurrent glioblastoma (GBM) and leptomeningeal metastases (LM) [116]. - The Phase 2b trial for rhenium (186Re) obisbemeda is expected to enroll up to 31 patients over approximately 24 months, focusing on small- to medium-sized tumors [118]. - The ReSPECT-GBM trial is designed to explore increased dosing and multiple doses, with overall survival as the primary endpoint for future registrational trials [117]. - The ReSPECT-LM Phase 1 clinical trial for rhenium (186Re) obisbemeda began screening patients in Q4 2021 after receiving FDA Fast Track designation [124]. - Interim results from the ReSPECT-LM trial showed a consistent decrease in CSF tumor cell count/ml and good tolerability among all patients [127]. - A single dose of rhenium (186Re) obisbemeda in Cohort 1 achieved absorbed doses of 18.7 to 29.0 Gy to the ventricles and cranial subarachnoid spaces [128]. Financial Performance - Grant revenue recognized was $1.2 million and $3.6 million for the three and nine months ended September 30, 2023, respectively [143]. - Research and development expenses for the three months ended September 30, 2023, were $2.493 million, a decrease of $0.5 million compared to the same period in 2022 [145]. - General and administrative expenses for the three months ended September 30, 2023, were $1.998 million, a decrease of approximately $0.2 million compared to the same period in 2022 [149]. - The company expects aggregate research and development expenditures to increase significantly during the remainder of 2023 due to increased costs for the ReSPECT-LM clinical trial [147]. - Cash and cash equivalents decreased to $11.0 million as of September 30, 2023, from $18.1 million as of December 31, 2022, a decline of 39.0% [155]. - Net cash used in operating activities for the nine months ended September 30, 2023 was $11.0 million, slightly higher than $10.7 million in the same period of 2022 [170]. - Total net cash provided by financing activities for the nine months ended September 30, 2023 was $3.97 million, down from $13.35 million in the same period of 2022 [166]. - The accumulated deficit as of September 30, 2023 was $476.7 million, indicating ongoing financial challenges [155]. - The company raised approximately $4.3 million from the issuance of 1,819,993 shares under the September 2022 Distribution Agreement from January 1, 2023 to September 30, 2023 [158]. Grants and Funding - The company has an active $3.0 million NIH/NCI grant to support the clinical development of rhenium (186Re) obisbemeda for recurrent GBM [109]. - The CPRIT Grant provides up to $17.6 million over three years for the development of rhenium (186Re) obisbemeda, with a matching fund requirement of $1 for every $2 awarded by CPRIT [126]. Strategic Collaborations and Innovations - Plus Therapeutics has established a GMP-validated R&D and manufacturing facility in San Antonio, Texas, to support the production of rhenium (186Re) obisbemeda for clinical trials [107]. - The collaboration with Medidata Solutions has resulted in a Synthetic Control Arm® platform to enhance the Phase 2 clinical trial of rhenium (186Re) obisbemeda [120]. - Plus Therapeutics aims to minimize radiation exposure to healthy tissues while maximizing locoregional delivery and efficacy through its innovative drug formulation approaches [104]. - The company is focused on treating rare and difficult-to-treat cancers with significant unmet medical needs, leveraging its advanced radiotherapeutic platform [106]. Future Plans - The company plans to submit a pediatric brain tumor IND for rhenium (186Re) obisbemeda in Q4 2023 or Q1 2024 [133]. - The company has an ongoing need to raise additional cash to fund future clinical development programs and operations [156]. Expenses and Income - Stock-based compensation expense for Q3 2023 was $148,000, a 14.7% increase from $129,000 in Q3 2022 [152]. - Interest income for Q3 2023 was $119,000, compared to $48,000 in Q3 2022, representing a 147.9% increase [153]. - Interest expense decreased to $87,000 in Q3 2023 from $173,000 in Q3 2022, a reduction of 49.7% [153]. - The company expects interest expense to decrease in 2023 compared to 2022 due to scheduled debt principal repayments [154].