Aankondiging • Apr 25
Plus Therapeutics Inc Initiates Manufacturing Activities With SpectronRx Under A Master Services Agreement To Support GMP Pivotal Trial Readiness For REYOBIQ Plus Therapeutics, Inc. announced the initiation of manufacturing activities and technology transfer with SpectronRx under a previously executed Master Services Agreement (MSA), in support of late-stage clinical manufacturing of Rhenium-186 and REYOBIQ. With SpectronRx serving as a second GMP manufacturing site alongside Radiomedix, and Rhenium-186 isotope supplied through Telix Pharmaceuticals, Plus strengthens the reliability of its multi-partner supply chain infrastructure. The MSA includes the technology transfer of the REYOBIQ manufacturing process, Rhenium-186 isotope processing, analytical methods, as well as technical and regulatory expertise supporting future commercial scale production. The SpectronRx’s facility in Indiana will provide on-demand manufacturing capabilities for both Rhenium-186 isotope production and REYOBIQ drug manufacturing within the same facility, improving coordination across the radiopharmaceutical production process and simplifying logistics. REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program. Aankondiging • Apr 10
Plus Therapeutics, Inc. Appoints Eric J. Daniels as Chief Development Officer, Effective April 20, 2026 Plus Therapeutics, Inc. announced the appointment of Eric J. Daniels, M.D., MBA, as Chief Development Officer, effective April 20, 2026. Dr. Daniels is a seasoned biotechnology executive with more than two decades of experience spanning clinical development, regulatory strategy, corporate operations, and business development. He most recently served as Chief Development Officer at Kiora Pharmaceuticals, where he oversaw the company’s full development portfolio, including clinical, preclinical, and CMC activities, and worked closely with executive leadership and Kiora’s board of directors to define and execute development strategy. Dr. Daniels brings a unique combination of development and entrepreneurial experience, having co-founded Bayon Therapeutics and previously served as Chief Executive Officer of OccuRx, where he led all aspects of corporate strategy, clinical development, and operations. Earlier in his career, he held senior leadership roles at Cytori Therapeutics, Inc., where he contributed to global clinical development programs, strategic partnerships, and international commercialization initiatives. Dr. Daniels received his M.D. from the David Geffen School of Medicine at University of California Los Angeles and his MBA from the UCLA Anderson School of Management. He holds a Bachelor of Science in Molecular and Cell Biology from the University of California, Berkeley. Aankondiging • Apr 08
Plus Therapeutics Inc Receives AMA PLA Code for CNSide® CSF Tumor Cell Enumeration Test, Advancing Reimbursement and U.S. Commercial Adoption Plus Therapeutics, Inc. announced that the American Medical Association (AMA) has approved a new, Proprietary Laboratory Analyses (PLA) Current Procedural Terminology (CPT) code for its CNSide® Cerebrospinal Fluid (CSF) Tumor Cell Enumeration (TCE) test. The dedicated billing code, 0640U, effective July 1, 2026, establishes a unique reimbursement identifier for the CNSide CSF TCE test, supporting payer claims processing and facilitating broader clinical adoptions as the Company continues the U.S. commercial launch of its CNS metastases diagnostic platform. Key implications of the newly assigned PLA code 0640U: Supports payer reimbursement processes. Provides a dedicated billing code specific to the CNSide CSF Tumor Cell Enumeration test, enabling standardized claims submission and facilitating payer coverage determinations. Facilitates clinician adoption. Simplifies ordering and billing processes for clinicians and cancer centers evaluating patients with suspected leptomeningeal metastases. Enables national utilization tracking. PLA coding allows tracking of test utilization through claims data, supporting real-world evidence generation related to clinical outcomes and health economics. Supports ongoing U.S. commercial launch. The coding milestone strengthens the reimbursement infrastructure supporting the Company’s ongoing U.S. launch of CNSide CSF test. Aankondiging • Apr 03
Plus Therapeutics Announces Reverse Stock Split for Continued Listing on the Nasdaq Capital Market Plus Therapeutics, Inc. announced that the Company’s Board of Directors has approved a reverse stock split of its shares of common stock at a ratio of 1-for-25. The reverse stock split will become effective at 12:01 a.m. Eastern Time on April 2, 2026, and the Company’s common stock will open for trading on The Nasdaq Capital Market on a post-split basis on April 2, 2026 under the Company’s existing trading symbol. The reverse stock split is being implemented to increase the per share trading price of the Company’s common stock for the purpose of ensuring a share price high enough to comply with the minimum $1.00 bid price requirement for continued listing on The Nasdaq Capital Market. Aankondiging • Mar 27
Plus Therapeutics, Inc. Announces Appointment of Ron Andrews to Its Board of Directors Plus Therapeutics, Inc. announced the appointment of diagnostics industry veteran Ron Andrews to its Board of Directors. Mr. Andrews currently is an experienced leader in the Diagnostics and Molecular Diagnostics industry with over 35 years leading various sized organizations from divisions of large global entities such as Abbott Diagnostics, Roche Molecular Diagnostics and LifeTechnologies/Thermo Fisher to public CEO roles in successful start-up organizations like Clarient Inc. and Oncocyte Inc. Most recently, Mr. Andrews has focused on assisting venture capital firms’ portfolio companies with interim CEO and Executive Chairman roles to bring emerging molecular technology companies through product development and fund-raising cycles. He has been instrumental in over $600M of capitalization for the various entities he has led or chaired and has led over $15B in exits over the course of his career. Mr. Andrews has held numerous board positions in public and private companies as well as served as a member of the Board of Governors of CancerLinQ LLC, a wholly-owned non-profit subsidiary of the American Society of Clinical Oncology. He currently serves on the Board of Trustees for Wofford College and several privately-held Molecular Diagnostic companies. Mr. Andrews graduated from Wofford College in 1981 with degrees in Biology and Chemistry. Reported Earnings • Mar 15
Full year 2025 earnings: EPS and revenues exceed analyst expectations Full year 2025 results: US$0.29 loss per share. Revenue: US$5.21m (down 11% from FY 2024). Net loss: US$22.4m (loss widened 73% from FY 2024). Revenue exceeded analyst estimates by 2.9%. Earnings per share (EPS) also surpassed analyst estimates by 2.5%. Revenue is forecast to grow 53% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Aankondiging • Mar 14
Plus Therapeutics, Inc., Annual General Meeting, May 14, 2026 Plus Therapeutics, Inc., Annual General Meeting, May 14, 2026. Aankondiging • Feb 25
Plus Therapeutics, Inc. Announces New Category III CPT Code for Convection-Enhanced Delivery Used with REYOBIQ Plus Therapeutics, Inc. announced the American Medical Association's (AMA) CPT®? (Current Procedural Terminalology) Editorial Panel approved a new Category III CPT code to track utilization of convection-enhanced delivery (CED) used in the administration of REYOBIQ for recurrent glioblastoma (rGBM) and pediatric brain cancer (PBC). The approved Category III CPT code for convection-enhanced delivery of REYOBIQ in recurrent glioblastoma and pediatric brain cancer - the most prevalent malignant tumors of the brain and central nervous system - marks a major step in bringing market access for an innovative treatment targeting an aggressive and deadly disease resistant to conventional treatments. This milestone reflects the culmination of years of REYOBIQ development and represents an important advancement in path to commercialization and reimbursement. With standardized REYOBIQ clinical use now tracked under the new CPT code, its utilization can be evaluated as a bridge to approval and broad adoption. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6 million grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company's ReSPECT-P BC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense's Peer Reviewed Cancer Research Program. New Risk • Feb 15
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$16m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Shareholders have been substantially diluted in the past year (over 29x increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$6.7m net loss in 3 years). Market cap is less than US$100m (US$48.7m market cap). Aankondiging • Jan 22
Plus Therapeutics, Inc. Provides Business Update on REYOBIQ Clinical Program and U.S. CNSide Commercialization Plus Therapeutics, Inc. provided a business update and highlights REYOBIQ clinical progress and CNSide US commercialization. Overview of anticipated company milestones for 2026: REYOBIQ clinical program: Define optimal dose/interval for REYOBIQ in the ReSPECT-LM Phase 2 trial; anticipate reporting data in third quarter of 2026; Completing enrollment in the ReSPECT-GBM Phase 2 trial for glioblastoma and conduct an end of phase meeting with the FDA to align on pivotal trial design, with data expected in fourth quarter of 2026; Complete commercial manufacturing scale up for REYOBIQ; Begin enrollment in the ReSPECT -PBC pediatric brain cancer Phase 1 trial. REYOBIQ commercial roll out: Obtain a total of 150 million US lives covered under multiple commercial payor agreements; Obtain Medicare and Medicaid coverage; Achieve a commercial order rate in excess of 1,250 tests per year; Launch portfolio of additional CSF tumor characterization tests that expand the CNSide testing platform. CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases. Aankondiging • Jan 14
Plus Therapeutics, Inc. has completed a Composite Units Offering in the amount of $15 million. Plus Therapeutics, Inc. has completed a Composite Units Offering in the amount of $15 million.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 39,473,684
Price\Range: $0.38
Discount Per Security: $0.0266 Aankondiging • Jan 08
Plus Therapeutics, Inc. Announces Read Out of Type B Meeting with the FDA with Goal of Accelerating Approval of REYOBIQ™? for Leptomeningeal Metastases Plus Therapeutics, Inc. announced the completion of a Type B meeting with the U.S. Food and Drug Administration (FDA) on next steps on REYOBIQ pivotal trial strategy for leptomeningeal metastases (LM). The meeting resulted in constructive discussion with the FDA regarding key elements of the potential pivotal study design for REYOBIQ in LM. Plus intends to incorporate the FDA's feedback in the current dose optimization trial and seek alignment with the FDA on a revised protocol, likely later this year. The company's goal is to be ready for a potential pivotal trial following completion of the current dose optimization trial and, ultimately, work towards the potential approval of REYOBIQ for patients affected by LM. Highlights of FDA responses to the Company's key enquiries: Accelerated approval - FDA indicated that accelerated approval may be appropriate for the LM indication, but there are insufficient data to support the use of circulating tumor cells (CTCs) as an intermediate clinical endpoint. FDA and Plus discussed that additional steps would be necessary to validate CTCs as a surrogate endpoint to potentially support other future applications. Primary and key endpoints - FDA recommended that the study evaluate an endpoint with established clinical benefit, such as overall survival, while encouraging further study of patient reported outcomes and neurological function as endpoints that could potentially support a marketing application. FDA and Plus aligned that CTCs could be considered for use as a secondary endpoint. Trial design and comparator group - FDA and Plus discussed a randomized controlled trial design approach and that the study may include an intrathecal chemotherapeutic as a comparator, as well as approaches to standardize the comparator and any additional interventions available under the trial protocol. Treated populations - FDA conveyed it may be reasonable to incorporate multiple histologies (i.e., multiple underlying disease etiologies) in a single trial. Aankondiging • Dec 04
Plus Therapeutics, Inc. Highlights Three REYOBIQ™ Clinical Data Presentations at 2025 WFNOS/SNO Annual Meeting Plus Therapeutics, Inc. announced three positive clinical data update presentations at the World Federation of Neuro-Oncology Societies/Society for Neuro-Oncology (WFNOS/SNO) Annual Meeting, November 19-23, 2025 in Honolulu, Hawaii. Phase 1 Multicenter Study of Multiple Doses of Rhenium (186Re) Obisbemeda (Reyobiq) for Leptomeningeal Metastases: Rationale, Design, and Preliminary Cohort 1 Data Overview: Completed ReSPECT-LM single dose trial showed REYOBIQ was well-tolerated up to a maximum tolerated dose of 66mCi, with a recommended phase 2 dose of 44.1 mCi, and absorbed doses delivered of >300 Gy observed; ReSPECT-LM open label, multidose Phase 1/2 trial initiated to identify maximum tolerated dose across varying dosing intervals and to characterize efficacy of multiple doses at optimal dose selected by assessing response using CNSide CSF tumor cell enumeration test; Response: Enrollment in Cohort 1 has begun with delivery of 13.2 mCi at 3 intervals; Three patients enrolled as of data cutoff: one patient has received all doses without dose limiting toxicity. Next steps: Phase 1b/2a dose optimization trial is enrolling with the ultimate goal of improving outcomes for LM patients; Phase 1/2 ReSPECT-GBM Trial of Rhenium (186 Re) Obisbemeda in Recurrent Glioblastoma: Safety and Efficacy from the Phase 1 and Update on Phase 2 Overview: Phase 1 dose-escalation study completed, with patients dosed from 1.0 mCi to 41.5 mCi, achieving a maximum absorbed tumor dose of 739.5 Gy. The Company's ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense's Peer Reviewed Cancer Research Program. Price Target Changed • Nov 26
Price target decreased by 7.6% to US$7.16 Down from US$7.75, the current price target is an average from 4 analysts. New target price is 1,096% above last closing price of US$0.60. Stock is down 53% over the past year. The company is forecast to post a net loss per share of US$0.31 next year compared to a net loss per share of US$1.95 last year. Aankondiging • Nov 25
Plus Therapeutics, Inc. Announces Completion of U.S. FDA Meeting on Future Clinical Development Plans for Reyobiq in Leptomeningeal Metastases Plus Therapeutics, Inc. announced it has completed a Type B meeting with the U.S. Food and Drug Administration (FDA) on November 7th to discuss its REYOBIQ clinical development plans for leptomeningeal metastases (LM) including the design of a planned pivotal or registrational trial. Leptomeningeal metastases are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. Reyobiq is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastase, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6 million grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company's ReSPECT-PBCclinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense's Peer Reviewed Cancer Research Program. Price Target Changed • Nov 21
Price target decreased by 9.4% to US$7.25 Down from US$8.00, the current price target is an average from 4 analysts. New target price is 1,261% above last closing price of US$0.53. Stock is down 55% over the past year. The company is forecast to post a net loss per share of US$0.31 next year compared to a net loss per share of US$1.95 last year. Major Estimate Revision • Nov 06
Consensus revenue estimates increase by 17% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$4.94m to US$5.81m. EPS estimate unchanged from -US$0.36 at last update. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target up from US$8.00 to US$9.67. Share price was steady at US$0.54 over the past week. Price Target Changed • Nov 03
Price target increased by 23% to US$9.67 Up from US$7.88, the current price target is an average from 3 analysts. New target price is 1,767% above last closing price of US$0.52. Stock is down 62% over the past year. The company is forecast to post a net loss per share of US$0.36 next year compared to a net loss per share of US$1.95 last year. Reported Earnings • Nov 02
Third quarter 2025 earnings: EPS and revenues miss analyst expectations Third quarter 2025 results: US$0.041 loss per share. Revenue: US$1.40m (down 4.1% from 3Q 2024). Net loss: US$4.42m (loss widened 54% from 3Q 2024). Revenue missed analyst estimates by 6.9%. Earnings per share (EPS) also missed analyst estimates by 45%. Revenue is forecast to grow 67% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. Aankondiging • Oct 22
Plus Therapeutics, Inc. Promotes Russ Havranek to Executive Vice President, Commercial and Corporate Strategy Plus Therapeutics, Inc. to lead commercialization strategy, Russ Havranek, MS, MBA, has been promoted to Executive Vice President, Commercial and Corporate Strategy. Mr. Havranek assumes his new commercial and corporate strategy role focused on CNSide’s launch of its diagnostic platform, having most recently served as Vice President of Corporate Strategy and New Product Planning at Plus. He was previously Vice President of Global Marketing and Business Development at Cytori Therapeutics. Mr. Havranek has over 28 years of leadership experience developing and commercializing diagnostic and therapeutic products at global, publicly traded, biopharma and medical device companies. His prior roles in marketing, strategy, business development, general management, and R&D focused on the oncology, rare disease, cardiology, and orthopedic markets. These roles were held at Johnson & Johnson, Guidant (now Abbott), Genentech (now Roche), DJO Global (now Enovis), Volcano (now Philips), and CareFusion (now Becton Dickinson). Mr. Havranek received a MBA in Marketing from the Haas School of Business at the University of California, Berkeley, a MS in Bioengineering from Clemson University, and a BS in Biomedical Engineering from Northwestern University. Major Estimate Revision • Sep 26
Consensus revenue estimates increase by 20% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$5.16m to US$6.21m. EPS estimate unchanged from -US$0.36 at last update. Biotechs industry in the US expected to see average net income decline 10% next year. Consensus price target of US$7.88 unchanged from last update. Share price rose 48% to US$0.62 over the past week. Aankondiging • Sep 23
Plus Therapeutics Announces Additional $1.9 Million Advance Payment from CPRIT Plus Therapeutics, Inc. announced that the Company received notice of an additional advance payment from the Cancer Prevention and Research Institute of Texas (CPRIT), the second-largest public cancer research funder globally. This $1.9 million payment is part of the Company’s previously awarded $17.6 million grant and is the second non-dilutive financing received from CPRIT following the $1.6 million receipt announced in July 2025. The funding supports and accelerates the Company’s clinical development of REYOBIQ™ for the ReSPECT-LM dose optimization trial and further develops the Company’s CNSide LM diagnostic test as a key pivotal trial endpoint. Price Target Changed • Sep 03
Price target decreased by 14% to US$7.88 Down from US$9.17, the current price target is an average from 4 analysts. New target price is 1,612% above last closing price of US$0.46. Stock is down 68% over the past year. The company is forecast to post a net loss per share of US$0.36 next year compared to a net loss per share of US$1.95 last year. Recent Insider Transactions • Aug 26
Independent Director recently bought US$54k worth of stock On the 22nd of August, Robert Lenk bought around 110k shares on-market at roughly US$0.49 per share. This transaction increased Robert's direct individual holding by 4x at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$107k more in shares than they have sold in the last 12 months. Major Estimate Revision • Aug 21
Consensus revenue estimates decrease by 17%, EPS upgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$6.18m to US$5.16m. EPS estimate increased from -US$0.685 to -US$0.36 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target down from US$9.17 to US$8.83. Share price fell 11% to US$0.48 over the past week. Aankondiging • Aug 19
Plus Therapeutics, Inc. Presents Positive ReSPECT-LM Clinical Trial Results of REYOBIQ in Leptomeningeal Metastases Plus Therapeutics, Inc. announced positive data from the ReSPECT-LM Phase 1 single dose escalation trial presented at the podium at the SNO/ASCO CNS Metastases Conference in Baltimore, MD. (Rhenium Nanoliposome,186RNL (REYOBIQ) for the Treatment of Leptomeningeal Metastases (LM): Clinical Study Results for Safety and Efficacy," highlighted study results to date from a total of 29 subjects in cohorts 1 - 6 who received 6.6 mCi, 13.2 mCi, 26.4 mCi, 44.10 mCi, 66.14 mCi, or 75mCi of REYOBIQ, respectively. Presented Data Highlights: Radiographic and clinical response rate of 76% and 87%, respectively, through day 112. CSF tumor cell enumeration (TCE) assays (CNSide test) showed a maximum reduction over baseline of 100% at day 28. Five of the 7 patients with a TCE response >80% survived at least 1 year. RNA sequencing of LM cells showed early induction of apoptosis, with an innate immune response followed by an adaptive immune response by day 28. Median overall survival of 9 months across cohorts 1-4 (20 patients) months, comparing favorably with literature reports of ~4 months. No dose-limiting toxicity (DLT) was observed in cohorts 1-4, with 1 DLT in each of cohorts 5 and 6 of grade 4 cytokenia. The majority of adverse events across the trial were Grade 1 and 2. Mean absorbed dose to the cranial and spinal subarachnoid space was 272 Gy in cohort 6. A recommended phase 2 single dose of 44.1 mCi was determined. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. The Company's ReSPECT-PBCclinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense's Peer Reviewed Cancer Research Program. Reported Earnings • Aug 15
Second quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2025 results: EPS: US$0.11 (up from US$0.45 loss in 2Q 2024). Revenue: US$1.39m (up 8.7% from 2Q 2024). Net income: US$5.15m (up US$8.09m from 2Q 2024). Revenue missed analyst estimates by 6.5%. Earnings per share (EPS) exceeded analyst estimates. Revenue is forecast to grow 68% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 72% per year but the company’s share price has fallen by 61% per year, which means it is significantly lagging earnings. Price Target Changed • Aug 15
Price target decreased by 8.3% to US$9.17 Down from US$10.00, the current price target is an average from 3 analysts. New target price is 1,591% above last closing price of US$0.54. Stock is down 61% over the past year. The company is forecast to post a net loss per share of US$0.69 next year compared to a net loss per share of US$1.95 last year. Aankondiging • Aug 14
Plus Therapeutics Presents Positive CNSide CSF Assay Platform Results at the 2025 SNO/ASCO CNS Metastases Conference Plus Therapeutics, Inc. announced positive data from a retrospective analysis of the CNSide Cerebrospinal Fluid (CSF) Assay Platform at the 2025 Society for Neuro-Oncology (SNO)/American Society of Clinical Oncology (ASCO) CNS Metastases Conference in Baltimore, Maryland. The presentation, titled "The Oncogenic Flip in Patients with Leptomeningeal Metastatic Disease (LMD): Longitudinal Detection in Cerebrospinal Fluid Tumor Cells (CSF-TCs) Reveals Implications for Differential Treatment of the LMD Tumor," was a retrospective, multi-center analysis of 613 CNSide assays ordered by 19 physicians from 5 institutions at 2 health systems for 218 individual patients. 74% of the patients were female and the cancers most analyzed were breast (n=105) and lung (n=65). The research was presented by Priya U.Kumthekar, M.D., Professor of Neurology and Medicine at Northwestern University. Data Demonstrated: CSF tumor cells detected in 67% (412/613) patients using CNSide; 66 patients underwent 2 or more CSF draws; About CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®?, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide®? CSF Assay Platform enables quantitative analysis and molecular characterization of tumor cells and circulating tumor DNA in the cerebrospinal fluid that inform and improve the management of patients with leptomeningeal metastases. Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, but the actual incidence may be higher as it can be difficult to diagnose. Postmortem studies show the frequency of LM to be around 20% or more, highlighting healthcare providers' need for more sensitive diagnostic options. Aankondiging • Jul 31
Plus Therapeutics, Inc.'s subsidiary CNSide Diagnostics, LLC Provides US Launch Update for its CNSide®? Diagnostic Plus Therapeutics, Inc. announced that its wholly-owned subsidiary, CNSide Diagnostics, LLC will make CNSide cerebrospinal fluid (CSF) assay platform and testing services commercially available in Texas in August 2025. Initial commercial focus will be on National Cancer Institute (NCI) Designated Cancer Centers, which treat the highest number of patients at risk for leptomeningeal metastases (LM) and previously used CNSide. Physicians, providers, hospitals or clinics interested in CNSide should contact CNSide through website. The CNSide testing platform is a proprietary, laboratory-developed program designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas who are at risk of developing cancer of the central nervous system (CNS). CNS metastases are an epidemic affecting as many as 30% of adult cancer patients and affect the highly protected CNS space. The comprehensive CNSide CSF Assay is a highly sensitive tool that diagnoses, monitors, and guides treatment, demonstrating significant advantages over the current standard of care. The superior clinical utility of CNSide has been shown in 9 peer-reviewed publications, a completed clinical trial, and has been validated in the market through real-world use. More than 11,000 CNSide tests have been performed at over 200 U.S. cancer institutions since 2020, delivering high sensitivity (92%) and specificity (95%), while influencing treatment decisions in over 90% of cases. By comparison, CSF cytology, the current standard of care for CNS Mets diagnosis, was originally developed over a century ago and offers suboptimal test sensitivity leading to missed or delayed diagnosis and treatment. Leptomeningeal metastases are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. The CNSide®? CSF Assay Platform enables quantitative analysis and molecular characterization of tumor cells and circulating tumor DNA in the cerebrospinal fluid that inform and improve the management of patients with leptomeningeal metastase. Aankondiging • Jul 23
Plus Therapeutics, Inc. Receives Notice of an Advance Payment of $1.6 Million from the Cancer Prevention and Research Institute of Texas Plus Therapeutics, Inc. announced that the Company received notice of an advance payment of $1.6 million from the Cancer Prevention and Research Institute of Texas (CPRIT), the second-largest public cancer research funder globally, as part of the Company’s previously awarded $17.6 million grant. The funding supports and accelerates the Company’s clinical development of REYOBIQ for the ReSPECT-LM dose optimization trial and further develops the Company’s CNSide LM diagnostic test as a key pivotal trial endpoint. Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies. REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program. Aankondiging • Jul 14
Plus Therapeutics, Inc., Annual General Meeting, Aug 07, 2025 Plus Therapeutics, Inc., Annual General Meeting, Aug 07, 2025. Aankondiging • Jul 08
Plus Therapeutics, Inc. Announces Initial Patients Successfully Treated in ReSPECT-LM Dose Optimization Trial for REYOBIQ in Leptomeningeal Metastases Plus Therapeutics, Inc. announced the treatment of its initial patients in the Company's ReSPECT-LM dose optimization trial for REYOBIQTM (rhenium Re186 obisbemeda) for the treatment of leptomeningeal metastases (LM). The dose optimization trial builds on promising results from the Company's completed Phase 1 single-dose escalation study, which demonstrated the feasibility of REYOBIQ for treating LM. The trial is designed in alignment with the FDA's Project Optimus to identify the optimal dosing regimen that maximizes efficacy and safety. The dose optimization study builds on encouraging results from the Company's previously announced Phase 1 trial, which showed a single dose of REYOBIQ delivered up to an average absorbed dose of >250 Gy to the cranial subarachnoid space. It also demonstrated that 5 of 7 patients achieving an over 80% reduction in LM tumor cells in the cerebrospinal fluid survived at least one year post-treatment. The company will also request an End of Phase 1 Type B meeting with the FDA to align on the clinical development plan and the design of a potential registrational trial. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastase, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. The Company's ReSPECT-PBCclinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense's Peer Reviewed Cancer Research Program. Aankondiging • Jul 01
Plus Therapeutics, Inc. Announces Fda Agreement to Initiate Respect-Lm Dose Optimization Trial for Reyobiq™? in Leptomeningeal Metastases Plus Therapeutics, Inc. announced the initiation of the ReSPECT-LM dose optimization trial for REYOBIQTM (rhenium Re186 obisbemeda) for the treatment of leptomeningeal metastases (LM). The dose optimization study builds on promising results from the Company's single-dose escalation trial. Key highlights include: Cohort 4 dose (44.1 mCi) was determined to be the RP2D; Pharmacodynamic and pharmacokinetic data showed that a single dose of REYOBIQ remained in the CSF for at least 7 days, and delivered up to an average absorbed dose of 253 Gy to the cranial subarachnoid space in Cohort 5; Neuroimaging results showed a clinical benefit rate1 of 76%, with 5 of 17 patients (29%) achieving partial responses and 8 (47%) maintaining stable disease through Day 112; Clinical examination showed a clinical benefit rate in 87% of evaluable patients, with 13 of 15 patients showing a partial response or stable disease based on physician assessment; No dose-limiting toxicities (DLTs) were observed in the first four cohorts; one Grade 4 DLT (thrombocytopenia) occurred in each of Cohorts 5 and 6; Biologic signals of early apoptosis, innate immune activation, and increased T-cell activity by Day 28, as observed through RNA sequencing of LM cells; 5 of 7 patients with over 80% reduction of LM tumor cells in CSF survived at least one year after initial treatment. The Company anticipates presenting these data and additional information from the completed single-dose escalation trial at the upcoming SNO/ASCO CNS Metastases Conference on August 14-16, 2025, in Baltimore, MD. The company will also request an End of Phase 1 Type B meeting with the FDA to align on the clinical development plan and the design of a potential registrational trial. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastase, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. The Company's ReSPECT-PBCclinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense's Peer Reviewed Cancer Research Program. Aankondiging • Jun 25
Plus Therapeutics, Inc. Announces FDA Clearance of Its Investigational New Drug Application Using Reyobiqtm for the Treatment of Childhood Brain Cancer Plus Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application (No. 168178) for REYOBIQTM (Rhenium Re186 Obisbemeda) for the treatment of pediatric patients with supratentorial recurrent, refractory, or progressive high-grade glioma (HGG) and ependymoma. The trial will be referred to as the ReSPECT-PBC trial and is funded by a $3.0M research grant from the U.S. Department of Defense. Key elements of the trial design include: Phase 1a/b (Dose Escalation): This phase will enroll an estimated 24 patients using a modified 3+3 dose escalation scheme to establish the MTD and recommended Phase 2 dose (RP2D). Safety assessment and alignment with the FDA will occur at defined intervals. Phase 2a: This phase will enroll approximately 32 patients (12 with ependymoma and 20 with HGG) at the RP2D to assess efficacy. REYOBIQ's targeted delivery via CED bypasses the blood-brain barrier, offering a novel approach to potentially improve outcomes for these patients. REYOBIQ is a novel radiotherapeutic designed to deliver high doses of beta radiation directly to brain tumors while minimizing damage to surrounding healthy tissue. The ReSPECT-PBC (pediatric brain cancer) trial builds on promising preclinical data and clinical results from the Company's adult recurrent glioblastoma trial (ReSPECT-GBM). As recently published in Nature Communications, ReSPECT-GBM demonstrated favorable safety and clinical response with a doubling of overall survival for those patients receiving a therapeutic dose of radiation defined as > 100 Gy. REYOBIQ™? is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. The Company's clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S., Department of Defense's Peer Reviewed Cancer Research Program. Aankondiging • Jun 09
Plus Therapeutics Receives a Letter from the Nasdaq Listing Qualifications Department of the Nasdaq Stock Market On June 3, 2025, Plus Therapeutics, Inc. received a letter from the Nasdaq Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) stating that the Company had regained compliance with the Rule 5250(c)(1) due to filing its Quarterly Report on Form 10-Q for the period ended March 31, 2025 (the “Quarterly Report”) with the U.S. Securities and Exchange Commission (the “SEC”) on May 30, 2025. As previously disclosed, on March 8, 2024, the Company received a written notice from the Staff, notifying the Company that it no longer complied with the requirement under Nasdaq Listing Rule 5550(b)(1) to maintain a minimum of $2.5 million in stockholders’ equity (the “Minimum Stockholders’ Equity Requirement”) for continued listing on The Nasdaq Capital Market or the alternative requirements of having a market value of listed securities of $35 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or two of the last three most recently completed fiscal years. On March 7, 2025, the Company received notification from Nasdaq that it had regained compliance with the Minimum Stockholders’ Equity Requirement and was subject to a Mandatory Panel Monitor until March 7, 2026. On June 3, 2025, the Staff notified the Company that it was not in compliance with the Minimum Stockholders’ Equity Requirement (the “June 3 Letter”). The Company reported stockholders’ equity (deficit) of ($23,641,000) in its Quarterly Report on Form 10-Q for the period ended March 31, 2025, and, as a result, did not satisfy the Minimum Stockholders’ Equity Requirement pursuant to Listing Rule 5550(b)(1). As a result, the Staff determined to delist the Company’s securities from Nasdaq, unless the Company timely requests an appeal of the Staff’s determination to a Hearings Panel (the “Panel”), pursuant to the procedures set forth in the Nasdaq Listing Rule 5800 Series. The Company must request a hearing no later than 4:00 p.m. Eastern Time on June 10, 2025. The Company plans to request a hearing before the Panel to appeal the June 3 Letter and to address all outstanding matters, including compliance with the Minimum Stockholders’ Equity Requirement, which hearing date has not been set as of the date of this Current Report on Form 8-K (this “Form 8-K”). While the appeal process is pending, the suspension of trading of the Company’s common stock, par value $0.001 per share (the “Common Stock”), will be stayed and the Common Stock will continue to trade on the Nasdaq Capital Market until the hearing process has concluded and the Panel issues a written decision. The Company has been informed that hearings are typically scheduled to occur approximately 30-45 days after the date of the hearing request. There can be no assurance, however, that the Panel will grant the Company’s request for continued listing or that the Company will be able to demonstrate compliance with Nasdaq Listing Rule 5550(b)(1) within any additional compliance period that may be granted by the Panel. Aankondiging • May 26
Plus Therapeutics Receives Notification of Deficiency from Nasdaq Related to Delayed Filing of Quarterly Report on Form 10-Q Plus Therapeutics, Inc. announced it received a delinquency notification letter from Nasdaq on May 21, 2025, which indicated that the Company was not in compliance with Nasdaq Listing Rule 5250(c)(1) as a result of the delayed filing of the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2025 (the “Quarterly Report”). The Nasdaq Listing Rule requires listed companies to timely file all required periodic financial reports with the U.S. Securities and Exchange Commission (the “SEC”). This notification has no immediate effect on the listing of the Company’s securities on Nasdaq. Nasdaq has informed the Company that it must submit a plan to regain compliance with respect to the filing requirement by July 21, 2025. If the plan is accepted, Nasdaq can grant an exception of up to 180 calendar dates from the due date of the filing, or until November 17, 2025, to regain compliance. The Company is working diligently to file the Quarterly Report as promptly as practical, and expects to return to a normal filing cadence for the remainder of 2025. Aankondiging • May 20
Plus Therapeutics Receives Non-Compliance Letter from Nasdaq Regarding Minimum Bid Requirement On May 16, 2025, Plus Therapeutics, Inc. (the Company") received notice from The Nasdaq Stock Market LLC (Nasdaq") that, because the closing bid price for the Company's common stock has fallen below $1.00 per share for 30 consecutive business days, the Company no longer complies with the minimum bid price requirement pursuant to Nasdaq Listing Rule 5550(a)(2) (the Minimum Bid Requirement"). Nasdaq's notice has no immediate effect on the listing or trading of the Company's common stock. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company is provided an initial compliance period of 180 calendar days, or until November 12, 2025, to regain compliance with the Minimum Bid Requirement. To regain compliance, the closing bid price of the Company's common stock must meet or exceed $1.00 per share for a minimum of 10 consecutive business days prior to November 12, 2025. If the Company does not achieve compliance with the Minimum Bid Requirement by November 12, 2025, the Company may be eligible for an additional 180 calendar days to regain compliance. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other Nasdaq initial listing standards, with the exception of the Minimum Bid Requirement, and provide written notice of its intention to cure the minimum bid price deficiency during the second compliance period by effecting a reverse stock split if necessary. If the Nasdaq staff determines that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible for such additional compliance period, Nasdaq will provide notice that the Company's common stock will be subject to delisting. In the event the Company receives notice that its common stock is being delisted, Nasdaq rules permit the Company to appeal any delisting determination by the Nasdaq staff. There can be no assurance that the Company will be able to regain compliance with the Minimum Bid Requirement or maintain compliance with the other listing requirements. The Company intends to monitor the closing bid price of its common stock and may, if appropriate, consider implementing available options to regain compliance with the Minimum Bid Requirement. Aankondiging • May 16
Plus Therapeutics, Inc. announced delayed 10-Q filing On 05/15/2025, Plus Therapeutics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. New Risk • May 07
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$8.50m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (48% average daily change). Negative equity (-US$8.9m). Shareholders have been substantially diluted in the past year (298% increase in shares outstanding). Market cap is less than US$10m (US$8.50m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$11m net loss in 3 years). Aankondiging • Apr 19
Plus Therapeutics, Inc. Announces Board and Committee Changes On April 18, 2025, the Board of Directors (the “Board”) of Plus Therapeutics, Inc. (the “Company”) unanimously appointed Mr. Kyle Guse to serve as a director of the Board, effective immediately. Mr. Guse is being appointed to the Board to fill the vacancy created by the resignation of Mr. Greg Petersen, and is expected to stand for reelection at the Company’s next annual meeting of stockholders. The Board has determined that Mr. Guse satisfies the definition of an “independent director” under the Nasdaq listing standards and the Company’s Corporate Governance Guidelines. Mr. Guse was also appointed to the Audit Committee and Compensation Committee of the Board and as Chairman of the Audit Committee. Mr. Guse currently serves as the Chief Legal Officer of DDC Enterprise Ltd., an NYSE-American-listed international consumer foods company, a position he has held since September 2023. From January 2013 to May 2023, Mr. Guse was Chief Financial Officer, General Counsel and Secretary of Atossa Therapeutics, Inc., a Nasdaq-listed biotechnology company developing treatments and prevention for breast cancer. Mr. Guse’s experience includes 30 years of counseling innovative, rapid growth companies through all aspects of finance, corporate governance, securities laws and commercialization, with a particular focus on mergers and acquisitions and capital markets transactions. Mr. Guse has practiced law at several of the largest international law firms, including from January 2012 through January 2013 as a partner at Baker Botts LLP and, prior to that, from October 2007 to January 2012, as a partner at McDermott Will & Emery LLP. Before working at McDermott Will & Emery, Mr. Guse served as a partner at Heller Ehrman LLP. Mr. Guse began his career as an accountant at Deloitte and he is an inactive Certified Public Accountant and member of the Bars in California and Washington. Mr. Guse earned a B.S. in business administration and an M.B.A. from California State University, Sacramento, and a J.D. from Santa Clara University School of Law. Aankondiging • Apr 15
Plus Therapeutics, Inc. Presents New Data Highlighting Clinical Benefit and Safety of REYOBIQ in the ReSPECT-LM Clinical Trial for Patients with Leptomeningeal Metastases Plus Therapeutics, Inc. announced the online availability of new data on its lead compound REYOBIQ™ (rhenium Re186 obisbemeda) in an abstract for both an oral presentation and a poster to be presented at the Nuclear Medicine and Neurooncology conference to be held May 9-10, 2025 in Vienna, Austria. The abstract, titled, "Rhenium Obisbemeda (REYOBIQ) in Leptomeningeal Metastases," highlights additional data from the Company's completed Phase 1 ReSPECT-LM dose escalation trial demonstrating a dose dependent increase in the average absorbed dose to the cranial and spinal subarachnoid space reaching 253Gy in Cohort 5. Neuroimaging response data was available for 16 patients as of the data cutoff with five of those (31%) showing a partial response. An additional seven patients showed stable disease by neuroimaging through day 112 for a Clinical Benefit Rate (complete response + partial response + stable disease) of 75%. Additionally, a clinical response based on the physician evaluation showed a decrease in disease findings in two of 14 evaluable patients (14%) and 10 patients showed stable findings through day 112 for an 86% Clinical Benefit Rate. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapy cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated. REYOBIQ™™ is being evaluated for the treatment of recurrent gllioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. Major Estimate Revision • Apr 03
Consensus revenue estimates increase by 40% The consensus outlook for revenues in fiscal year 2025 has improved. 2025 revenue forecast increased from US$3.48m to US$4.86m. Forecast losses expected to reduce from -US$1.32 to -US$0.767 per share. Biotechs industry in the US expected to see average net income decline 13% next year. Consensus price target down from US$14.40 to US$9.38. Share price fell 49% to US$0.77 over the past week. Aankondiging • Apr 01
Plus Therapeutics, Inc. has withdrawn its Follow-on Equity Offering in the amount of $16 million. Plus Therapeutics, Inc. has withdrawn its Follow-on Equity Offering in the amount of $16 million.
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Security Type: Equity Warrant Reported Earnings • Mar 28
Full year 2024 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2024 results: US$1.95 loss per share (improved from US$4.24 loss in FY 2023). Revenue: US$5.82m (up 19% from FY 2023). Net loss: US$13.0m (loss narrowed 2.5% from FY 2023). Revenue exceeded analyst estimates by 5.4%. Earnings per share (EPS) missed analyst estimates by 11%. Revenue is forecast to grow 61% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 64% per year but the company’s share price has fallen by 57% per year, which means it is significantly lagging earnings. Aankondiging • Mar 20
Plus Therapeutics Introduces REYOBIQ, FDA- Accepted Proprietary Name for Lead Drug Candidate Plus Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has previously accepted the Company's new proprietary name, REYOBIQ, for its lead therapeutic candidate. A request for proprietary name review for REYOBIQ must be submitted once the marketing application (NDA) is submitted. All communications regarding the USAN-adopted and INN-recommended rhenium Re186 obisbemeda generic name will now utilize the proprietary name REYOBIQ. REYOBIQ (rhenium Re 186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6 million grant by the Cancer Prevention & Research Institute of Texas (CPRIT). Aankondiging • Mar 19
Plus Therapeutics, Inc. to Report Q4, 2024 Results on Mar 27, 2025 Plus Therapeutics, Inc. announced that they will report Q4, 2024 results After-Market on Mar 27, 2025 Price Target Changed • Mar 18
Price target decreased by 10.0% to US$14.40 Down from US$16.00, the current price target is an average from 5 analysts. New target price is 2,480% above last closing price of US$0.56. Stock is down 70% over the past year. The company is forecast to post a net loss per share of US$1.75 next year compared to a net loss per share of US$4.24 last year. Aankondiging • Mar 10
Plus Therapeutics Regains Compliance with Nasdaq Minimum Stockholder's Equity Requirement Plus Therapeutics, Inc. announced that on March 7, 2025 the Company received confirmation from Nasdaq that the Company has regained compliance with Nasdaq’s minimum stockholders’ equity requirement. The Company’s common stock will continue to be listed and traded on The Nasdaq Capital Market. New Risk • Feb 27
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$5.2m). Shareholders have been substantially diluted in the past year (30% increase in shares outstanding). Market cap is less than US$10m (US$6.37m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$34m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Aankondiging • Feb 26
Plus Therapeutics, Inc. Advances Lead Drug Rhenium (186Re) Obisbemeda for Patients with Leptomeningeal Metastases Plus Therapeutics, Inc. announced the completion of the ReSPECT-LM Phase 1 single-dose escalation trial, having determined an RP2D. The ReSPECT-LM single-dose escalation trial assessed the safety, tolerability, and potential efficacy of intrathecally administered Rhenium (186Re) Obisbemeda in patients with leptomeningeal metastases (LM). Additional details on the ReSPECT-LM trial can be found here. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapy cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated. Aankondiging • Feb 20
Plus Therapeutics, Inc. Appoints Michael Rosol as Chief Development Officer Plus Therapeutics, Inc. announced the appointment of Michael Rosol, Ph.D., as Chief Development Officer. Dr. Rosol will lead the company’s clinical, pre-clinical, and biomarker development activities. Dr. Rosol has 25 years of experience in clinical trial design, operations, and regulatory execution. Most recently, he served as Chief Medical Officer and Senior Vice President at Navidea Biopharmaceuticals. Prior to his most recent role, Dr. Rosol worked at Novartis Pharmaceuticals, leading key biomarker development and translational imaging groups. Dr. Rosol’s Ph.D. from Boston University focused on biomedical and radionuclide imaging, and he has held various academic appointments at Harvard Medical School/Massachusetts General Hospital, Mayo Clinic, Children’s Hospital of Los Angeles/USC Medical School, and the Medical University of South Carolina. New Risk • Jan 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 30% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$12m free cash flow). Negative equity (-US$5.2m). Shareholders have been substantially diluted in the past year (30% increase in shares outstanding). Market cap is less than US$10m (US$6.90m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$34m net loss in 3 years). Aankondiging • Dec 18
Plus Therapeutics, Inc. Presents Positive ReSPECT-LM Phase 1 Interim Data for Breast Cancer Patients with Leptomeningeal Metastases At the 2024 San Antonio Breast Cancer Symposium Plus Therapeutics, Inc. presented data updating the progress of its ReSPECT-LM Phase 1 clinical trial of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) in leptomeningeal disease (LM) with a specific focus on breast cancer patients. The data were presented at the 2024 San Antonio Breast Cancer Symposium on December 10-13. The data were presented in a session titled ‘Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) for the Treatment of Leptomeningeal Metastases (LM): Update on Phase 1 Dose Escalation Study,’ by Andrew Brenner, M.D., Ph.D., Professor and Kolitz/Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, San Antonio. Key Highlights from the Presentation: Nine of 20 patients with LM primary breast cancer were treated and evaluable through five dose escalation cohorts, with the maximum tolerated dose yet to be reached Primary breast cancer biomarker status across the 9 patients were: ER positive/HER2 negative: n=3 HER2 positive: n=2 Triple negative: n=4 Patients received a single intrathecal dose of Rhenium (186Re) Obisbemeda, ranging from 6.6 to 66.14 mCi of radiation Only one dose-limiting toxicity (thrombocytopenia) was reported (Cohort 5) A linear increase in absorbed dose was observed from Cohorts 1 through 5, with an average absorbed dose of 253 Gy to the cranial subarachnoid space in Cohort 5 Circulating tumor cell (CTC) and radiographic (MRI) response data were available for 8 of the 9 breast cancer patients with LM, and clinical response data were available for 7 of the 9 patients Best response rates (response only) were: CTC: 88% (7/8) MRI imaging: 25% (2/8) Clinical: 29% (2/7) Clinical benefit rates (response and stable disease) were: CTC: 100% (8/8) MRI imaging: 75% (6/8) Clinical: 71 % (5/7) Median overall survival for 9 breast cancer patients was 9 months, with 2 patients surviving beyond 600 days post-treatment Next steps: Initiate ReSPECT-LM Phase 1b single-dose breast expansion cohort in first quarter of 2025 to further evaluate single-dose safety and efficacy of Rhenium (186Re) Obisbemeda. Aankondiging • Nov 26
Plus Therapeutics Presents Positive ReSPECT-LM Phase 1 Interim Data for Leptomeningeal Metastases at the 2024 SNO Annual Conference Plus Therapeutics, Inc. presented data updating the progress of its ReSPECT-LM Phase 1 clinical trial of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) in leptomeningeal disease (LM). The data were presented at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting November 21-24 in Houston, Texas. The data were presented in a session titled, “Rhenium (186Re) Obisbemeda (rhenium nanoliposome,186RNL) for the treatment of leptomeningeal metastases (LM): Summary of the Phase 1 dose escalation study and Phase 2 administered dose selection,” by Andrew Brenner, M.D., Ph.D., Professor and Kolitz/Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, San Antonio. ReSPECT-LM Single Administration Dose Escalation Trial: Overview: Twenty patients with LM were treated and evaluable through Cohort 5, receiving a single intrathecal dose of Rhenium (186Re) Obisbemeda of up to 66.14 mCi of radiation. Primary cancer diagnosis for the 20 patients with LM included breast cancer (n = 9), non-small cell lung cancer (n = 5), and other primary cancers (n = 6). Safety: The safety profile through Cohort 5 was favorable, with 1 dose-limiting toxicity (thrombocytopenia) observed in Cohort 5. Pharmacodynamic and pharmacokinetic analyses indicated that after a single administration, Rhenium (186Re) Obisbemeda remained in the cerebrospinal fluid space for at least 7 days and achieved average absorbed doses of up to 253 Gy to the cranial subarachnoid space in Cohort 5. Response: The best clinical benefit rate from a single dose of Rhenium (186Re) Obisbemeda, assessed from baseline to day 112, was measured through complete response, partial response, and stable disease across three key metrics: Circulating tumor cells: 93% (14/15 patients) responded, including 1 complete response and 1 stable case. MRI imaging: 75% (12/16 patients), with 5 responses and 7 stable cases. Clinical Response: 86% (12/14 patients), with 2 responses and 10 stable cases. Median overall survival for Cohorts 1-4 was 9 months, with 6 out of the 16 patients alive at the time of analysis. Three of the 20 patients received up to 3 doses of Rhenium (186Re) Obisbemeda under compassionate use IND, all surviving over 400 days, with one exceeding 30 months. Next steps: The first patient in Cohort 6 has been treated using a modified dose of 75 mCi. Cohort 6 is anticipated to conclude in First Quarter 2025. Planning is underway for a Phase 1b single dose expansion cohort trial using the Cohort 4 dose of 44 mCi, which is expected to fully enroll in 2025. ReSPECT-LM Multiple Administration Dose Interval Compression Trial. Obtained agreement from FDA to begin the ReSPECT-LM multi-administration trial for patients with LM (IND 153715); enrollment is expected to begin in early 2025 at seven U.S. trial sites. The trial will be a two-part study aimed at evaluating the safety, dosing intervals, and efficacy of administering multiple doses of Rhenium (186Re) Obisbemeda to patients with LM. Aankondiging • Nov 22
CNSide Diagnostics, LLC to Present Positive FORESEE Clinical Trial Summary Demonstrating Utility of CNSide™ Cerebrospinal Fluid Assay in Diagnosis and Clinical Management of Patients with Leptomeningeal Metastases CNSide Diagnostics, LLC will present data from the FORESEE trial showcasing the CNSide CSF Assay Platform’s utility in diagnosing and guiding clinical decision making for breast cancer and non-small cell lung cancer patients with LM. The data will be presented at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting November 21-24 in Houston, Texas. Key highlights: The FORESEE trial achieved its primary endpoint, demonstrating that CNSide influenced treatment decisions in over 90% of cases evaluated, surpassing the predetermined 20% primary endpoint target; CNSide demonstrated enhanced sensitivity in detecting tumor cells (80%) vs. CSF cytology (29%) in patients with LM; CNSide identified actionable mutations in the CSF, such as HER2 amplification, influencing 24% of therapeutic selection decisions; CNSide exhibited high specificity, with no tumor cells detected in patients without LM; CNSide demonstrated improved Negative Predictive Value in ruling out LM (25%) vs. CSF cytology (10%); CNSide revealed HER2 positivity in LM tumors in 60% of breast cancer patients with HER2-negative primary tumors, informing physician treatment strategies. Reported Earnings • Nov 17
Third quarter 2024 earnings: EPS and revenues exceed analyst expectations Third quarter 2024 results: US$0.37 loss per share (improved from US$1.00 loss in 3Q 2023). Revenue: US$1.46m (up 17% from 3Q 2023). Net loss: US$2.87m (loss narrowed 11% from 3Q 2023). Revenue exceeded analyst estimates by 28%. Earnings per share (EPS) also surpassed analyst estimates by 34%. Revenue is forecast to grow 68% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. Price Target Changed • Nov 15
Price target increased by 23% to US$20.00 Up from US$16.25, the current price target is an average from 3 analysts. New target price is 1,609% above last closing price of US$1.17. Stock is down 56% over the past year. The company is forecast to post a net loss per share of US$2.30 next year compared to a net loss per share of US$4.24 last year. New Risk • Nov 15
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 2.5% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$11m free cash flow). Negative equity (-US$7.6m). Earnings are forecast to decline by an average of 2.5% per year for the foreseeable future. Market cap is less than US$10m (US$7.43m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$46m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Shareholders have been diluted in the past year (30% increase in shares outstanding). Aankondiging • Nov 05
Plus Therapeutics, Inc. to Report Q3, 2024 Results on Nov 14, 2024 Plus Therapeutics, Inc. announced that they will report Q3, 2024 results After-Market on Nov 14, 2024 New Risk • Oct 03
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 15% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$11m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Negative equity (-US$7.6m). Shareholders have been substantially diluted in the past year (105% increase in shares outstanding). Market cap is less than US$10m (US$8.31m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$37m net loss in 3 years). Aankondiging • Oct 01
Plus Therapeutics Reports ReSPECT-GBM Clinical Trial Update at the 2024 Congress of Neurological Surgeons Annual Meeting Plus Therapeutics, Inc. presented an update on the ongoing ReSPECT-GBM Phase 1/2 clinical trial, evaluating the Company’s lead asset Rhenium (186Re) Obisbemeda for the treatment of recurrent glioblastoma. The data were presented at the 2024 Congress of Neurological Surgeons (CNS) Annual Meeting on September 30, 2024, in Houston, Texas. The presentation, titled “Treatment of Recurrent Glioblastoma (rGBM) via Convection Enhanced Delivery (CED) with Rhenium (186Re) Obisbemeda (Rhenium-186 Nanoliposome, 186RNL): ReSPECT-GBM Phase 1/2 Trial Update” was delivered by lead investigator and neurosurgeon John Floyd, M.D., Associate Professor and Chair of the Department of Neurosurgery at the University of Texas Health Science Center San Antonio. The data highlights the continued favorable safety profile and encouraging efficacy results of Rhenium (186Re) Obisbemeda in a patient population with historically poor prognosis. ReSPECT-GBM is a first-in-human, open-label, Phase 1/2 study investigating feasibility, dose escalation, and critical convection enhanced delivery (CED) parameters to determine the maximum tolerated dose (MTD), maximum feasible dose (MFD), safety, and potential efficacy of Rhenium (186Re) Obisbemeda in recurrent adult glioma (IND 116117). Key Highlights from the ReSPECT-GBM Phase 1/2 Trial Update: 42 total patients have enrolled thus far at 3 sites and with 19/42 patients having been treated to date at the recommended Phase 2 dose (22.3 mCi in 8.8 mL) in tumors of approximately 20 cm3 or less. All Phase 2 patients have recurrent, histologically confirmed glioblastoma; 1 recurrence, bevacizumab naïve, single tumor of approximately 20 cm3 or less (small-to-medium sized tumors). Average tumor size in Phase 2 was 7.5 mL (range 0.9-22.8 mL). Increases in absorbed dose correlated with specific drug delivery parameters such as infused dose and volume, maximal convection flow rate, and number of catheters. Rhenium (186Re) Obisbemeda continues to show a favorable safety profile in the 42 enrolled patients; one dose-limiting toxicity (hemiplegia) has been reported, which was observed in Cohort 8 (41.5 mCi and 16.3 mL). In Phase 2, most adverse events (AEs) were mild (73.5%) or moderate (18.8%), and largely unrelated (37.7%), or unlikely related (27.1%) to the drug. Of the 9 severe adverse events (SAEs), only 2 were related to the study drug. Average absorbed radiation dose to the tumor in Phase 2 was 300 Gy (n=18, 1 patient still under analysis). To date, 88.9% of Phase 2 patients met key CED drug delivery parameters shown to correlate with overall survival, achieving a tumor absorbed dose >100 Gy and radiation coverage of >70%. 29/42 patients treated thus far participated in the Phase 1 dose escalation phase of the trial (Note: as per protocol, 6/42 patients were included in both the Phase 1 and Phase 2 trial arms and related analyses). Phase 1 dose-escalation increased administered doses from 1.0 mCi to 41.5 mCi and volumes from 0.66 mL to 16.3 mL. In terms of objective tumor response based on quantitative image analysis, a statistically significant reduction in tumor volume rate change was seen in tumors receiving > 100 Gy absorbed dose (n=11 patients analyzed to date, p<0.005). Sufficient tumor coverage correlated with tumor control, while regrowth occurred outside treated areas. Aankondiging • Sep 09
Plus Therapeutics, Inc. Provides Non-Compliance Update As previously disclosed, on March 8, 2024, Plus Therapeutics, Inc. (the Company") received a written notice (the Notice") from the Listing Qualifications staff of The Nasdaq Stock Market (Nasdaq") notifying the Company that it no longer complies with the requirement under Nasdaq Listing Rule 5550(b)(1) to maintain a minimum of $2.5 million in stockholders' equity (the Minimum Stockholders' Equity Requirement") for continued listing on The Nasdaq Capital Market or the alternative requirements of having a market value of listed securities of $35 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or two of the last three most recently completed fiscal years (the Alternative Standards"). The Notice stated that the Company's Form 10-K for the year ended December 31, 2023, disclosed stockholders' equity of ($1,348,000) as of December 31, 2023, and that, as of March 8, 2024, the Company did not meet the Alternative Standards. As required by Nasdaq, the Company submitted its plan to regain compliance with the Minimum Stockholders' Equity Requirement on April 22, 2024. On September 5, 2024, the Company received a letter from Nasdaq (the Letter") notifying the Company that it had not regained compliance with Nasdaq Listing Rule 5550(b)(1) and that, as a result, unless the Company timely requests an appeal of this determination to a Nasdaq Hearings Panel, Nasdaq would move to suspend trading of the Company's common stock and to have the Company's shares of common stock, par value $0.001 per share, delisted from The Nasdaq Capital Market. Accordingly, the Company intends to timely appeal the determination, which will automatically stay any suspension or delisting action pending the Hearings Panel's decision and the expiration of any additional extension period granted by the Hearings Panel following the hearing. As a result, the Company's shares of common stock is expected to remain listed on The Nasdaq Capital Market through at least that time. There can be no assurance, however, that the Hearings Panel will grant the Company's request for continued listing or that the Company will be able to demonstrate compliance with Nasdaq Listing Rule 5550(b)(1) within any additional compliance period that may be granted by the Hearings Panel. Major Estimate Revision • Aug 21
Consensus EPS estimates fall by 11% The consensus outlook for fiscal year 2024 has been updated. 2024 expected loss increased from -US$2.08 to -US$2.30 per share. Revenue forecast of US$5.32m unchanged since last update. Biotechs industry in the US expected to see average net income decline 14% next year. Consensus price target of US$16.25 unchanged from last update. Share price rose 2.8% to US$1.46 over the past week. Price Target Changed • Aug 18
Price target decreased by 16% to US$16.25 Down from US$19.33, the current price target is an average from 4 analysts. New target price is 1,095% above last closing price of US$1.36. Stock is down 42% over the past year. The company is forecast to post a net loss per share of US$2.30 next year compared to a net loss per share of US$4.24 last year. New Risk • Aug 16
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$11m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$11m free cash flow). Negative equity (-US$7.6m). Shareholders have been substantially diluted in the past year (98% increase in shares outstanding). Market cap is less than US$10m (US$7.99m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$41m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Reported Earnings • Aug 16
Second quarter 2024 earnings: EPS and revenues exceed analyst expectations Second quarter 2024 results: US$0.45 loss per share. Revenue: US$1.28m (down 31% from 2Q 2023). Net loss: US$2.94m (loss widened 98% from 2Q 2023). Revenue exceeded analyst estimates by 15%. Earnings per share (EPS) also surpassed analyst estimates by 15%. Revenue is forecast to grow 63% p.a. on average during the next 3 years, compared to a 23% growth forecast for the Biotechs industry in the US. Price Target Changed • Aug 15
Price target increased by 37% to US$26.50 Up from US$19.33, the current price target is an average from 3 analysts. New target price is 1,793% above last closing price of US$1.40. Stock is down 40% over the past year. The company is forecast to post a net loss per share of US$2.17 next year compared to a net loss per share of US$4.24 last year. Aankondiging • Aug 08
Plus Therapeutics, Inc. to Report Q2, 2024 Results on Aug 14, 2024 Plus Therapeutics, Inc. announced that they will report Q2, 2024 results After-Market on Aug 14, 2024 New Risk • Jun 25
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.13m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$4.8m). Shareholders have been substantially diluted in the past year (129% increase in shares outstanding). Market cap is less than US$10m (US$9.13m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$45m net loss in 3 years). Aankondiging • Jun 10
Plus Therapeutics, Inc. Receives the Resignation of Dr. Norman Lafrance, Its Chief Medical Officer, Effective June 12, 2024 On June 5, 2024, Plus Therapeutics, Inc. received the resignation of Dr. Norman LaFrance, its Chief Medical Officer. Dr. LaFrance’s resignation is effective June 12, 2024. New Risk • Jun 05
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$4.8m). Shareholders have been substantially diluted in the past year (129% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$45m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Market cap is less than US$100m (US$14.8m market cap). Major Estimate Revision • May 22
Consensus revenue estimates increase by 104% The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from US$3.40m to US$6.93m. Forecast losses expected to reduce from -US$2.29 to -US$2.19 per share. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target of US$16.50 unchanged from last update. Share price fell 8.2% to US$2.13 over the past week. Aankondiging • May 22
Plus Therapeutics, Inc., Annual General Meeting, Aug 15, 2024 Plus Therapeutics, Inc., Annual General Meeting, Aug 15, 2024, at 09:00 US Eastern Standard Time. Reported Earnings • May 17
First quarter 2024 earnings: EPS exceeds analyst expectations First quarter 2024 results: US$0.76 loss per share (improved from US$2.07 loss in 1Q 2023). Revenue: US$1.68m (up 231% from 1Q 2023). Net loss: US$3.26m (loss narrowed 32% from 1Q 2023). Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 31%. Revenue is forecast to grow 62% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 54% per year but the company’s share price has fallen by 60% per year, which means it is significantly lagging earnings. Aankondiging • May 15
Plus Therapeutics, Inc. to Report Q1, 2024 Results on May 15, 2024 Plus Therapeutics, Inc. announced that they will report Q1, 2024 results After-Market on May 15, 2024 New Risk • May 12
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.2% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$1.3m). Earnings are forecast to decline by an average of 0.2% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (72% increase in shares outstanding). Market cap is less than US$10m (US$9.24m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$53m net loss in 3 years). Revenue is less than US$5m (US$4.9m revenue). Aankondiging • May 07
Plus Therapeutics, Inc. announced that it expects to receive $17.948504 million in funding from Aigh Capital Management, LLC Plus Therapeutics, Inc. announced that it has entered into a securities purchase agreement with new institutional investors and Company insiders to issue up to an aggregate of 3,238,627 shares of its common stock at an issue price of $2.022 per share for the gross proceeds of $6,548,503.794; Series A warrants to purchase up to an aggregate of 3,238,627 shares of common stock at an exercise price of $1.772 per share for an aggregate gross proceeds of up to $5,738,847.044 and Series B warrants to purchase up to 3,238,627 shares of common stock at an exercise price of $1.772 per share for an aggregate of up to approximately $5,738,847.044 for the aggregate gross proceeds of $17,948,503.794 on May 6, 2024. The Series B warrants will be exercisable until the one-year anniversary of the effectiveness of a registration statement covering the resale of shares of common stock underlying the Series B warrants. The private placement is expected to close on or about May 8, 2024, subject to satisfaction of customary closing conditions. Price Target Changed • Apr 30
Price target increased by 50% to US$16.50 Up from US$11.00, the current price target is an average from 4 analysts. New target price is 848% above last closing price of US$1.74. Stock is down 53% over the past year. The company is forecast to post a net loss per share of US$2.29 next year compared to a net loss per share of US$4.24 last year. Aankondiging • Apr 23
Plus Therapeutics, Inc. Receives $3 Million Award Recommendation from the United States Department of Defense Plus Therapeutics, Inc. announced it has been selected for funding by the Department of Defense (DoD) office of the Congressionally Directed Medical Research Programs (CDMRP). The award is expected to commence in Third Quarter 2024 and will support the planned expansion of the Company’s clinical trial for pediatric brain cancer. The DoD Peer Reviewed Cancer Research Program (PRCRP) Advancing Cancer Care through Clinical Trials Award will be utilized to fund a Phase 1 dose escalation trial to address the fiscal year 2023 PRCRP Topic Area of Pediatric Brain Tumors. This study will investigate a novel therapeutic, Rhenium (186Re) Obisbemeda (186RNL), delivered by Convection Enhanced Delivery (CED), for the treatment of supratentorial recurrent, refractory, or progressive pediatric high-grade glioma (HGG) and ependymoma. It is expected to begin enrollment in the second half of 2024. Aankondiging • Mar 27
Plus Therapeutics, Inc. Announces Validation & Clinical Implementation of Csf-01 Leptomeningeal Cancer Cell Diagnostic Plus Therapeutics, Inc. announced it has successfully completed key validation testing and implementation of its tumor cell enumeration assay, known as CSF-01, to be used initially as an exploratory endpoint in its ReSPECT-LM clinical trials. Plus’ CSF-01 cancer cell enumeration test is an exploratory endpoint in the ReSPECT-LM Phase 1 trial that has shown promise in the trial’s early cohorts. In Phase 1/Part A of the ReSPECT-LM trial presented at the 2023 SNO/ASCO Meeting in San Francisco, Plus showed an average 53% reduction in CSF tumor cells 28 days after a single intrathecal administration of rhenium (186Re) obisbemeda in patients with LM. On December 12, 2023, Plus announced its partnership with K2bio (Houston, Texas) to implement Plus’ CSF-01 diagnostic for LM cancers in the ReSPECT-LM trials. While validated for use in Plus’ clinical development programs, full Clinical Laboratory Improvement Amendments (CLIA) certification is not anticipated until 2025. The ReSPECT-LM trial, including support for CSF-01 testing, is currently receiving grant funding from the Cancer Prevention and Research Institute of Texas (CPRIT). The FORSEE trial was performed by the original developer and licensor of CSF-01 and is a multi-center, prospective clinical trial enrolling patients with breast or non-small cell lung cancer (NSCLC) who have suspicious or confirmed LM. If the FORSEE data is positive, the company intend to work toward increasing commercial reimbursement for the CLIA-certified test and explore partnerships to maximize diagnostic utilization for the broader CNS cancer space. About Leptomeningeal Metastases (LM): LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers, and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal, with a 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells. Yet, there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months if untreated. About Rhenium (186Re) obisbemeda: Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver directly targeted high-dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce off-target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). Aankondiging • Mar 15
Plus Therapeutics Receives Non-Compliance Update from Nasdaq On March 8, 2024, Plus Therapeutics, Inc. (the Company") received a letter (the Notice") from the Listing Qualifications staff of The Nasdaq Stock Market (Nasdaq") notifying the Company that it no longer complies with the requirement under Nasdaq Listing Rule 5550(b)(1) to maintain a minimum of $2.5 million in stockholders' equity for continued listing on the Nasdaq Capital Market (the Equity Standard") or the alternative requirements of having a market value of listed securities of $35 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or two of the last three most recently completed fiscal years (the Alternative Standards"). The Notice states that the Company's Form 10-K for the year ended December 31, 2023, disclosed stockholders' equity of ($1,348,000) as of December 31, 2023, and that, as of March 8, 2024, the Company did not meet the Alternative Standards. The Notice has no immediate effect on the Company's listing on the Nasdaq Capital Market. Nasdaq is providing the Company 45 calendar days from the date of the Notice, or until April 22, 2024, to submit a plan to regain compliance with the Equity Standard (the Compliance Plan"). If the Compliance Plan is accepted, Nasdaq may grant the Company an extension of up to 180 calendar days from the date of the Notice, or until September 4, 2024, to regain compliance with the Equity Standard. If the Company does not timely submit a Compliance Plan or if such plan is not accepted, or if it is accepted and the Company does not regain compliance in the required timeframe, Nasdaq could provide notice that the Company's common stock is subject to delisting. The Company plans to timely submit a Compliance Plan, is evaluating its options for complying with the Equity Standard or the Alternatives Standards, including pursuing additional capital raising opportunities, and will continue to monitor its stockholders' equity. However, there can be no assurance that the Company will be able to regain or maintain compliance with the Equity Standard or the Alternatives Standards. Major Estimate Revision • Mar 12
Consensus revenue estimates fall by 34% The consensus outlook for revenues in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from US$5.14m to US$3.40m. Forecast losses increased from -US$1.92 to -US$2.29 per share. Biotechs industry in the US expected to see average net income decline 8.5% next year. Consensus price target up from US$11.00 to US$11.33. Share price fell 19% to US$1.77 over the past week. 
