Paulness
6日前
NEWS -- Plus Therapeutics Presents New Data Highlighting Clinical Benefit and Safety of REYOBIQ in the ReSPECT-LM Clinical Trial for Patients with Leptomeningeal Metastases
New abstract published ahead of the Nuclear Medicine and Neurooncology Conference shows promise for REYOBIQ
HOUSTON, April 15, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announces 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. Furthermore, there was no dose limiting toxicity (DLT) observed in the first four cohorts, with a grade 4 DLT (thrombocytopenia), one in each of Cohorts 5 and 6.
Finally, RNA sequencing of LM cells showed early induction of apoptosis, with an innate immune response followed by an increase in T cells and an adaptive immune response by Day 28. Further details can be found here; the Company will provide additional data and explanation following the meeting.
"This newly-presented ReSPECT-LM data further reinforces our confidence in the potential utility of REYOBIQ in these critically ill patients with the devastating diagnosis of Leptomeningeal Metastases," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "Reyobiq can be delivered at very high doses of radiation to the cancer at the recommended phase 2 dose and shows promising response data across multiple parameters while simultaneously being well tolerated by normal organs and tissues."
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 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 REYOBIQ™ (rhenium Re186 obisbemeda)
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 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).
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.
These statements include, without limitation, statements regarding the potential promise of REYOBIQ™, expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates; the Company’s clinical trials, including statements regarding the timing and characteristics of the ReSPECT-LM single dose and multi-dose clinical trials; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2024, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
3週前
NEWS -- Plus Therapeutics Inc (PSTV) Q4 2024 Earnings Call Highlights: Strategic Advances Amid Financial Challenges
Plus Therapeutics Inc (PSTV) reports promising clinical progress and strategic funding, despite financial hurdles in its latest earnings call.
Summary:
Cash and Investments Balance: $3.6 million as of December 31, 2024, compared to $8.6 million at December 31, 2023.
Grant Revenue: $5.8 million in 2024, up from $4.9 million in 2023.
Operating Loss: $14.7 million in 2024, compared to $13.3 million in 2023.
Net Loss: $13 million or $0.95 per share in 2024, compared to $13.3 million or $4.24 per share in 2023.
Equity Financing: $15 million in gross proceeds from an underwritten equity financing in early March 2025.
Grant Funding for 2025: Expected to be in the range of $6 to $8 million.
Additional Grant Proceeds: $7.2 million remaining to be received from grants, with $2 million received in Q1 2025.
Department of Defense Grant: Over $2 million remaining from a $3 million award for the Respect pediatric brain cancer trial.Release Date: March 27, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
Plus Therapeutics Inc (PSTV, Financial) successfully completed an underwritten equity financing of $15 million, strengthening its balance sheet and funding key milestones into mid-2026.The company received FDA orphan designation for its lead drug, Robic, for use in patients with leptomeningeal metastasis (LM) due to lung cancer, adding to previous designations for breast cancer.Plus Therapeutics Inc (PSTV) has expanded its senior leadership team with experienced professionals in oncology and diagnostics, enhancing its clinical and commercial capabilities.The company reported promising clinical data for its lead drug, Robic, in phase one trials, showing a median overall survival of 9 months for LM patients, compared to the historical 4 months.Plus Therapeutics Inc (PSTV) is on track to launch its CNI tumor cell enumeration test commercially in 2025, which could significantly increase the total addressable market for Robic.Negative Points
The company's cash and investments balance decreased from $8.6 million at the end of 2023 to $3.6 million at the end of 2024, indicating a need for careful financial management.Plus Therapeutics Inc (PSTV) reported an operating loss of $14.7 million in 2024, up from $13.3 million in 2023, primarily due to increased spending on clinical trials.The net loss for 2024 was $13 million, which, although slightly lower than 2023, still reflects significant financial challenges.The company faces uncertainties related to FDA approval processes and the need for further clinical trials to validate its drug's efficacy and safety.Plus Therapeutics Inc (PSTV) must navigate complex market access activities, including state licensures and payer agreements, to successfully commercialize its CNI test.Q & A Highlights
Q: On the CN insight, do you anticipate building up a major sales force or will you look for partners to commercialize this?
A: Marc Hedrick, President and CEO: We do not plan to build a major sales force. This is a niche opportunity, and we are starting with academic neuro-oncologists at major oncology centers. There are about 300 neuro-oncologists in the country, and our initial focus will be on this narrow group of thought leaders and major institutions. Over time, we may expand to the broader medical oncology market. Partnering in the US or outside is something we will consider in the future.
Q: The recurrent GBM trial is the most advanced. What must happen to meet the goal of data this year?
A: Marc Hedrick, President and CEO: Although superficially GBM is in late-stage phase two, LM could get approved before. We've enrolled over 50 patients, completed phase one, and are over halfway through phase two. The key is adding new sites, and we now have five sites enrolling. We are focused on completing the enrollment of 11 more patients this year.
Q: Can you remind me of the powering assumptions behind the GBM trial?
A: Marc Hedrick, President and CEO: The phase two trial's comparator is the standard of care. We've conducted real-world control arms, and patients treated with monotherapy live under 8 months. The trial is powered at 80% with a comparator of about 8 months median overall survival. The trial size is around 100 to 150 patients, and discussions with the FDA about using real-world control data could reduce the number of active patients needed.
Q: On the LM study, you proposed a dose expansion at the 44 milli dose. Is that an additional cohort to the phase one study or part of the phase two study?
A: Marc Hedrick, President and CEO: Ideally, the FDA would sign off on a phase 2 trial focused on breast cancer, with 15 patients each for HER2 positive and negative at the 44 milli dose. The phase one dose is a basket trial including various cancer patients. The goal is to sort out patient segmentation by molecular subtype and align with the FDA on endpoints, potentially leading to a phase 2 or phase 23 pivotal design.
Q: Regarding the multi-dose study, would you wait for the first data to come out before initiating a phase two, or would you build that into a phase two?
A: Marc Hedrick, President and CEO: We plan to move directly into a phase two or phase 1B. The multi-dose data will be important for performance data and trial design. The phase one data is promising, with long tail survival observed. We aim to pursue a single dose approval quickly, with dose optimization layered on as data becomes available.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Paulness
1月前
NEWS -- Plus Therapeutics Introduces REYOBIQ™, FDA-Accepted Proprietary Name for Lead Drug Candidate
REYOBIQ™ (rhenium Re186 obisbemeda) continues to be under clinical investigation for Leptomeningeal Metastases (LM) and Recurrent Glioblastoma (GBM)
HOUSTON, March 20, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announces the U.S. Food and Drug Administration (FDA) has conditionally 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™.
"Branding is an important part of preparing for commercialization, and the establishment of the REYOBIQ™ brand will enable investigators, investors, and potential patients to connect with our rhenium-based radiotherapeutic beyond its chemical identity," said Russ Havranek, Plus Therapeutics VP of Corporate Strategy and New Product Planning. "We are looking forward to building familiarity with the new REYOBIQ™ name and logo, as we believe it will foster stronger stakeholder engagement and reinforce the promising progress we are making in developing targeted radiotherapeutics for LM and GBM.”
About REYOBIQ™ (rhenium Re186 obisbemeda)
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 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).
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://plustherapeutics.com/.
Investor Contact
Jules Abraham
Managing Director, Communications
CORE IR
mailto://Julesa@coreir.com
Paulness
1月前
NEWS -- Plus Therapeutics to Announce Fourth Quarter and Full Year 2024 Financial Results and Host Conference Call on March 27, 2025
HOUSTON, March 19, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announces that the Company will report fourth quarter and full year 2024 financial results on Thursday, March 27, 2025 after market close. Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.
Webcast and Conference Call
Date/Time: Thursday, March 27, 2025 @ 5:00 PM ET
Webcast: https://edge.media-server.com/mmc/p/5r5hkcqq
Dial-in Link: https://register-conf.media-server.com/register/BI74b28f5ee02c4c1c89a835bfb6bdc1c8
Participants are encouraged to pre-register any time before the call through the dial-in link. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.
Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.
These statements include, without limitation, statements under the heading Upcoming Events and Expected Milestones, and statements regarding the following: CLIA compliance certification of the Company’s Houston-based clinical laboratory; the potential promise of rhenium (186Re) obisbemeda; expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates; the Company’s clinical trials, including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC clinical trials; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts;; development and utility of CNSide leptomeningeal metastases diagnostic test.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, including the ability of the Company to come into compliance with The Nasdaq Capital Market listing requirements; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Jules Abraham
Managing Director, Communications
CORE IR
mailto://Julesa@coreir.com
Paulness
1月前
NEWS -- D. Boral Capital Served as Exclusive Placement Agent to Plus Therapeutics, Inc. (Nasdaq:PSTV) in Connection with its up to $15.0 Million Private Placement
HOUSTON, TX / ACCESS Newswire / March 11, 2025 / On March 4th, Plus Therapeutics, Inc. (Nasdaq:PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announced the pricing of a private placement with gross proceeds to the Company expected to be approximately $15.0 million.
"This financing coupled with ongoing grant support strengthens our ability to rapidly advance our CNS cancer therapies," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "We remain focused on meeting key near term milestones and creating long-term value for our stockholders."
The offering consists of 28,042,140 common units (or pre-funded units), each consisting of (i) one (1) share of common stock or one (1) pre-funded warrant, (ii) one (1) Series A warrant to purchase one (1) share of common stock per warrant (the "Series A Warrants") and (iii) one (1) Series B warrant to purchase one (1) share of common stock per warrant (the "Series B Warrants" and together with the Series A Warrants, the "Warrants"). The offering price per common unit is $0.66 (or $0.659 for each pre-funded unit, which is equal to the offering price per common unit to be sold in the offering minus an exercise price of $0.001 per pre-funded warrant). Of the securities issued in the offering, 22,727,270 of the common units (or pre-funded units), are being issued in consideration of new capital subscriptions and 5,314,870 are being issued in exchange for the cancelation of previously issued outstanding senior convertible promissory notes. The pre-funded warrants will be immediately exercisable and may be exercised at any time until exercised in full. For each pre-funded unit sold in the offering, the number of common units in the offering will be decreased on a one-for-one basis. The initial exercise price of each Series A Warrant is $1.32 per share of common stock. The Series A Warrants are exercisable following stockholder approval and expire 60 months thereafter. The number of shares of common stock issuable under the Series A Warrants is subject to adjustment as described in more detail in the report on the Company's Current Report on Form 8-K that will be filed with the U.S. Securities and Exchange Commission (the "SEC") in connection with the offering (the "Form 8-K"). The initial exercise price of each Series B Warrant is $1.98 per share of common stock or pursuant to an alternative cashless exercise option. The Series B Warrants are exercisable following stockholder approval and expire 30 months thereafter. The number of shares of common stock issuable under the Series B Warrants is subject to adjustment as described in more detail in the Form 8-K.
Aggregate gross proceeds to the Company are expected to be approximately $15.0 million plus the benefit to the Company from the cancelation of the $3.2 million in principal amount of senior convertible notes exchanged in the offering. The transaction is expected to close on or about March 4, 2025, subject to the satisfaction of customary closing conditions. The funds received in the offering will be placed in escrow, subject to release only upon confirmation that the Company will not be delisted pursuant to the previously disclosed Nasdaq hearings process. If the Company does not receive confirmation from Nasdaq by March 31, 2025, the offering will be terminated and the funds returned to the investors. The Company expects to use the net proceeds from the offering for the repayment of the Company's outstanding balance on its outstanding promissory notes not exchanged in the offering, repurchase of certain outstanding warrants and general corporate purposes and working capital.
D. Boral Capital is acting as the Placement Agent for the offering. Hogan Lovells US LLP is acting as counsel to the Company. Sichenzia Ross Ference Carmel LLP is acting as counsel to D. Boral Capital.
The securities described above are being sold in a private placement transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The securities were offered only to accredited investors. Pursuant to a registration rights agreement with the investors, the Company has agreed to file one or more registration statements with the SEC covering the resale of the common stock and the shares issuable upon exercise of the pre-funded warrants and Warrants.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and LM. The Company has built a supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. The Company is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs, including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
About D. Boral Capital
D. Boral Capital LLC is a premier, relationship-driven global investment bank headquartered in New York. The firm is dedicated to delivering exceptional strategic advisory and tailored financial solutions to middle-market and emerging growth companies. With a proven track record, D. Boral Capital provides expert guidance to clients across diverse sectors worldwide, leveraging access to capital from key markets, including the United States, Asia, Europe, the UAE, and Latin America.
A recognized leader on Wall Street, D. Boral Capital has successfully aggregated over $23 billion in capital since its inception in 2020, executing approximately 300 transactions across a broad range of investment banking products.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed "forward-looking statements," within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, related to, including but not limited to, the financing, the total investment amount raised in connection with the offering, the timing of the closing of the offering, the potential exercise of the pre-funded warrants and Warrants and gross proceeds generated by the Warrants exercise, the Company's clinical programs, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. We may, in some cases use terms such as "future," "possible," "believes," "potential," "continue," "expects," "plans," "may," "could," or "will," or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team and on information currently available to management that involve risks, potential changes in circumstances, assumptions, and uncertainties. All statements contained in this press release other than statements of historical fact are forward-looking statements, including, but not limited to, the timing for the closing of the offering, potential gross proceeds resulting from the financing (including whether funds are released from escrow), potential gross proceeds resulting from the exercises of the warrants sold and issued in the financing, use of the financing proceeds, including the development of the Company's CNS cancer therapies, and achievement of key milestones with respect to the Company's product candidates and therapies. Results or events in future periods could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: Nasdaq does not provide the required confirmation; the early stage of the Company's product candidates and therapies; the results of the Company's research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company's liquidity and capital resources and its ability to raise additional cash; the outcome of the Company's partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, including the ability of the Company to come into compliance with The Nasdaq Capital Market listing requirements; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company's clinical trials and any commercial level product demand; and material security breach or cybersecurity attack affecting the Company's operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics' business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics' annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC's website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
For more information, please contact:
D. Boral Capital LLC
Email: mailto://info@dboralcapital.com
Telephone: +1(212)-970-5150
SOURCE: D. Boral Capital LLC
Paulness
1月前
NEWS -- Plus Therapeutics Regains Compliance with Nasdaq Minimum Stockholders’ Equity Requirement
HOUSTON, March 10, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company” or “Plus Therapeutics”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today 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.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://plustherapeutics.com/.
About CNSide Diagnostic, LLC
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. The Company is planning to commercialize CNSide™ in the U.S. in 2025.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements,” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, related to the Company’s ability to comply with the continued listing requirements of Nasdaq. All statements in this press release, other than statements of historical fact are forward-looking statements. We may, in some cases use terms such as “will,” “believe,” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Results or events in future periods could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the ability of the Company to maintain compliance with Nasdaq continued listing requirements; the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. The Company discusses some of these matters more fully, as well as certain risk factors that could affect the Company’s business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements the Company makes may turn out to be wrong and can be affected by inaccurate assumptions the Company might make or by known or unknown risks, uncertainties, and other factors, including those identified in this Current Report. Accordingly, you should not place undue reliance on the forward-looking statements made in this Current Report, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Jules Abraham
Managing Director, Communications
CORE IR
mailto://Julesa@coreir.com
Paulness
1月前
NEWS -- Plus Therapeutics Announces Peer-Reviewed Publication in Nature Communications Highlighting Promising Phase 1 Results for Rhenium (186Re) Obisbemeda in Glioblastoma
Rhenium (186Re) Obisbemeda demonstrates safety, response, and potential efficacy for glioblastoma (GBM) patients
Patients receiving >100 Gy of Rhenium (186Re) Obisbemeda achieved a median overall survival of 17 months, more than double the 8-month median overall survival with standard of care
HOUSTON, March 07, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announces the publication of results in a peer-reviewed manuscript titled, "Treatment of Recurrent Glioma by Rhenium (186Re) Obisbemeda (186RNL): a Phase 1 clinical trial" in the peer-reviewed medical journal Nature Communications.
“Peer-reviewed publication of our Phase 1 glioma data in a prestigious, high-impact factor journal is substantial validation for this important clinical program,” said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. “Based largely on this data, our ReSPECT-GBM Phase 2 trial is currently enrolling patients at leading medical centers, bringing us closer to delivering a much-needed treatment option for this devastating disease.”
Key highlights from the publication:
Twenty-one patients were treated with doses up to 22.3 mCi of Rhenium (186Re) Obisbemeda
No dose-limiting toxicity was observed, and most adverse events were unrelated to the study treatment
Median overall survival (OS) was 11 months, surpassing the standard of care for recurrent glioblastoma, which is approximately 8 months
Median OS was strongly correlated with radiation absorbed dose to the tumor and the percentage of tumor treated
Patients receiving >100 Gy (n=12) had a median OS of 17 months, compared to 6 months for those receiving
Paulness
2月前
NEWS -- Plus Therapeutics Granted U.S. FDA Orphan Drug Designation for Rhenium (186Re) Obisbemeda for the Treatment of Leptomeningeal Metastases in Patients with Lung Cancer
HOUSTON, March 06, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company” or “Plus Therapeutics”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Rhenium (186Re) Obisbemeda for the treatment of leptomeningeal metastases (LM) in patients with lung cancer.
“Receiving Orphan Drug Designation for Rhenium (186Re) Obisbemeda marks a significant milestone in our efforts to develop a much-needed therapy for lung cancer patients with leptomeningeal metastases,” said Mike Rosol, Ph.D., Plus Therapeutics Chief Development Officer. “These patients currently have limited treatment options, and the growing incidence of LM in lung cancer underscores the urgency for new therapies. This designation, in combination with our previously granted Fast Track designation, strengthens our pathway toward delivering an innovative, targeted radiotherapeutic solution for this highly underserved patient population.”
The FDA grants ODD status to an investigational drug or biologic intended to prevent, diagnose, or treat a rare disease or condition affecting fewer than 200,000 people in the United States. ODD provides certain benefits to drug developers, including seven potential years of market exclusivity, tax credits for qualified clinical trials, and exemptions from significant regulatory fees, including the Prescription Drug User Fee Act (PDUFA) charge of $4.3 million in 2025 and the Pediatric Research Equity Act (PREA) requirements.
This milestone follows the recent completion of the ReSPECT-LM Phase 1 single-dose trial, which established the recommended Phase 2 dose (RP2D). The Company is now advancing a Phase 2 single-dose expansion trial and a Phase 1 multiple-dose trial while actively engaging the FDA to define the optimal pivotal trial strategy.
Additional details on the ReSPECT-LM trial can be found here.
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 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 highly 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 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 live 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).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and LM. The Company has built a supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs, including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “believe,” and similar expressions. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.
These statements include, without limitation, statements relating to the significance of the FDA ODD grant to the advancement of Rhenium (186Re) Obisbemeda as potential treatment of patients who suffer from LM from breast and lung cancer patients; statements regarding the potential promise of rhenium (186Re) obisbemeda, including the next steps in developing the Company’s product candidates; and, the Company’s clinical trials, including statements regarding the Company’s engagement with the FDA with respect to the possibility of defining a pivotal trial strategy for certain of the Company’s clinical trials.
Results or events in future periods could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, including the ability of the Company to come into compliance with The Nasdaq Capital Market listing requirements; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
subslover
2月前
Plus Therapeutics Granted U.S. FDA Orphan Drug Designation for Rhenium (186Re) Obisbemeda for the Treatment of Leptomeningeal Metastases in Patients with Lung Cancer
HOUSTON, March 06, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company” or “Plus Therapeutics”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Rhenium (186Re) Obisbemeda for the treatment of leptomeningeal metastases (LM) in patients with lung cancer.
“Receiving Orphan Drug Designation for Rhenium (186Re) Obisbemeda marks a significant milestone in our efforts to develop a much-needed therapy for lung cancer patients with leptomeningeal metastases,” said Mike Rosol, Ph.D., Plus Therapeutics Chief Development Officer. “These patients currently have limited treatment options, and the growing incidence of LM in lung cancer underscores the urgency for new therapies. This designation, in combination with our previously granted Fast Track designation, strengthens our pathway toward delivering an innovative, targeted radiotherapeutic solution for this highly underserved patient population.”
The FDA grants ODD status to an investigational drug or biologic intended to prevent, diagnose, or treat a rare disease or condition affecting fewer than 200,000 people in the United States. ODD provides certain benefits to drug developers, including seven potential years of market exclusivity, tax credits for qualified clinical trials, and exemptions from significant regulatory fees, including the Prescription Drug User Fee Act (PDUFA) charge of $4.3 million in 2025 and the Pediatric Research Equity Act (PREA) requirements.
This milestone follows the recent completion of the ReSPECT-LM Phase 1 single-dose trial, which established the recommended Phase 2 dose (RP2D). The Company is now advancing a Phase 2 single-dose expansion trial and a Phase 1 multiple-dose trial while actively engaging the FDA to define the optimal pivotal trial strategy.
Additional details on the ReSPECT-LM trial can be found here.
Paulness
2月前
NEWS -- Plus Therapeutics Announces New Employment Inducement Grants
HOUSTON, March 05, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced that on February 28, 2025, it granted option awards to Dr. Michael Rosol, the Company’s new Chief Development Officer. The Company agreed to grant these equity awards to Dr. Rosol to induce him to commence employment with the Company.
The approved option awards are options to purchase up to 30,000 shares of the common stock of the Company. The options are scheduled to vest over four years, with one-fourth of the options vesting on the first anniversary of the grant date with the remaining options vesting thereafter in equal monthly installments. The vesting of the options is also subject to certain requirements, including Dr. Rosol’s continued service as an employee of the Company through the applicable vesting dates. The exercise price of the options is equal to the closing price of the Company’s common stock on February 28, 2025, the grant date.
The Company believes that these equity grants create a strong alignment of interests between Dr. Rosol and Company shareholders. The equity awards were granted outside of the Company’s 2020 Incentive Plan but generally have terms and conditions consistent with those set forth in that plan. The Company has filed a Form S-8 covering these equity awards.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
Paulness
2月前
NEWS -- Plus Therapeutics Secures Private Placement of Approximately $15 Million in Gross Proceeds
HOUSTON, March 04, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced the pricing of a private placement with gross proceeds to the Company expected to be approximately $15.0 million.
“This financing coupled with ongoing grant support strengthens our ability to rapidly advance our CNS cancer therapies,” said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. “We remain focused on meeting key near term milestones and creating long-term value for our stockholders.”
The offering consists of 28,042,140 common units (or pre-funded units), each consisting of (i) one (1) share of common stock or one (1) pre-funded warrant, (ii) one (1) Series A warrant to purchase one (1) share of common stock per warrant (the “Series A Warrants”) and (iii) one (1) Series B warrant to purchase one (1) share of common stock per warrant (the “Series B Warrants” and together with the Series A Warrants, the “Warrants”). The offering price per common unit is $0.66 (or $0.659 for each pre-funded unit, which is equal to the offering price per common unit to be sold in the offering minus an exercise price of $0.001 per pre-funded warrant). Of the securities issued in the offering, 22,727,270 of the common units (or pre-funded units), are being issued in consideration of new capital subscriptions and 5,314,870 are being issued in exchange for the cancelation of previously issued outstanding senior convertible promissory notes. The pre-funded warrants will be immediately exercisable and may be exercised at any time until exercised in full. For each pre-funded unit sold in the offering, the number of common units in the offering will be decreased on a one-for-one basis. The initial exercise price of each Series A Warrant is $1.32 per share of common stock. The Series A Warrants are exercisable following stockholder approval and expire 60 months thereafter. The number of shares of common stock issuable under the Series A Warrants is subject to adjustment as described in more detail in the report on the Company’s Current Report on Form 8-K that will be filed with the U.S. Securities and Exchange Commission (the “SEC”) in connection with the offering (the “Form 8-K”). The initial exercise price of each Series B Warrant is $1.98 per share of common stock or pursuant to an alternative cashless exercise option. The Series B Warrants are exercisable following stockholder approval and expire 30 months thereafter. The number of shares of common stock issuable under the Series B Warrants is subject to adjustment as described in more detail in the Form 8-K.
Aggregate gross proceeds to the Company are expected to be approximately $15.0 million plus the benefit to the Company from the cancelation of the $3.2 million in principal amount of senior convertible notes exchanged in the offering. The transaction is expected to close on or about March 4, 2025, subject to the satisfaction of customary closing conditions. The funds received in the offering will be placed in escrow, subject to release only upon confirmation that the Company will not be delisted pursuant to the previously disclosed Nasdaq hearings process. If the Company does not receive confirmation from Nasdaq by March 31, 2025, the offering will be terminated and the funds returned to the investors. The Company expects to use the net proceeds from the offering for the repayment of the Company’s outstanding balance on its outstanding promissory notes not exchanged in the offering, repurchase of certain outstanding warrants and general corporate purposes and working capital.
D. Boral Capital is acting as the Placement Agent for the offering. Hogan Lovells US LLP is acting as counsel to the Company. Sichenzia Ross Ference Carmel LLP is acting as counsel to D. Boral Capital.
The securities described above are being sold in a private placement transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The securities were offered only to accredited investors. Pursuant to a registration rights agreement with the investors, the Company has agreed to file one or more registration statements with the SEC covering the resale of the common stock and the shares issuable upon exercise of the pre-funded warrants and Warrants.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and LM. The Company has built a supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. The Company is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs, including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements,” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, related to, including but not limited to, the financing, the total investment amount raised in connection with the offering, the timing of the closing of the offering, the potential exercise of the pre-funded warrants and Warrants and gross proceeds generated by the Warrants exercise, the Company’s clinical programs, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. We may, in some cases use terms such as “future,” “possible,” “believes,” “potential,” “continue,” “expects,” “plans,” “may,” “could,” or “will,” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team and on information currently available to management that involve risks, potential changes in circumstances, assumptions, and uncertainties. All statements contained in this press release other than statements of historical fact are forward-looking statements, including, but not limited to, the timing for the closing of the offering, potential gross proceeds resulting from the financing (including whether funds are released from escrow), potential gross proceeds resulting from the exercises of the warrants sold and issued in the financing, use of the financing proceeds, including the development of the Company’s CNS cancer therapies, and achievement of key milestones with respect to the Company’s product candidates and therapies. Results or events in future periods could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: Nasdaq does not provide the required confirmation; the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, including the ability of the Company to come into compliance with The Nasdaq Capital Market listing requirements; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
Paulness
2月前
NEWS -- Plus Therapeutics Advances Lead Drug Rhenium (186Re) Obisbemeda for Patients with Leptomeningeal Metastases
ReSPECT- LM Phase 1 single dose is now complete, and the recommended Phase 2 dose (RP2D) for single administration therapy has been determined
AUSTIN, Texas, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company” or “Plus Therapeutics”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today 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). Enrollment in Cohort 6 was recently completed (75.0 mCi). The Cohort 4 dose (44.1 mCi) was determined to be the RP2D; no dose-limiting toxicities were observed at this dose level. One patient at the Cohort 4 dose was observed to have achieved a complete response, as evidenced by the eradication of tumor cells in the cerebrospinal fluid—a key therapeutic endpoint.
"With the RP2D established, we are advancing both a single dose-expansion Phase 2 trial and a multiple-dose Phase 1 trial of 44.1 mCi fractionated into three doses to further assess safety and efficacy," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "We remain on track to complete enrollment in both trials this year and are simultaneously engaging the U.S. Food & Drug Administration to define the optimal pivotal trial pathway."
Additional details on the ReSPECT-LM trial can be found here.
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 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 Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and LM. The Company has built a supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs, including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.
These statements include, without limitation, statements under the heading Upcoming Events and Expected Milestones, and statements regarding the following: the potential promise of rhenium (186Re) obisbemeda; expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates; the Company’s clinical trials, including statements regarding the timing and characteristics of the ReSPECT-LM single dose and multi-dose clinical trials; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, including the ability of the Company to come into compliance with The Nasdaq Capital Market listing requirements; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
Paulness
2月前
NEWS -- Plus Therapeutics Announces Leadership Appointments for its CNSide Diagnostics Subsidiary
Russell Bradley Named President & General Manager of CNSide
Dr. Marc Hedrick, Rick Hawkins, and Russell Bradley Join CNSide Board of Directors
Dr. Jonathan Stein Appointed CNSide Medical Director
AUSTIN, Texas, Feb. 24, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced that is has appointed Mr. Russell Bradley as the President and General Manager of its wholly-owned subsidiary, CNSide Diagnostics, LLC (“CNSide”). Furthermore, Plus has also appointed Dr. Marc Hedrick, Mr. Rick Hawkins, and Mr. Russell Bradley to the CNSide Board of Directors, and Dr. Jonathan Stein has been named CNSide Medical Director.
"On behalf of Plus and the CNSide board of directors, I am extremely pleased to welcome Russ Bradley to lead CNSide Diagnostics," said Marc H. Hedrick, Plus Therapeutics President and Chief Executive Officer. "Russ is a seasoned and experienced operator across the diagnostic landscape and will make an immediate impact on CNSide as we begin a pilot market introduction this quarter.”
Russ Bradley brings over 30 years of leadership experience in diagnostics and life sciences, having held senior executive roles at Abbott Laboratories, Luminex Corporation, and Beckman Coulter. Throughout his career, he has successfully launched and scaled market-leading diagnostic platforms, developed global growth strategies, and led business transformations.
"In recent months, through conversations with leading neuro-oncologists and the teams at Plus Therapeutics and CNSide Diagnostics, the urgent need for improved tools to test for and treat leptomeningeal disease has become abundantly clear," said Mr. Bradley. "I am excited to take on this role and build upon the substantial progress achieved by the team over the last nine months. Our immediate priority is to fully capitalize CNSide Diagnostics to support our early access and initial launch plans in the U.S.”
Dr. Jonathan Stein, CNSide’s new Medical Director, is a clinical laboratory executive with over 20 years of expertise in molecular diagnostics, assay development, and regulatory compliance. He has led multiple labs as Chief Science Officer and Medical Director, advancing oncology testing. Previously, he served as Medical Director at Gene By Gene and as a Research Investigator at M.D. Anderson Cancer Center.
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 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 CNSide Diagnostic, LLC
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™ LDT 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. The Company is planning to commercialize CNSide in the U.S. in 2025.
About CNSide Test
The CNSide Cerebrospinal Fluid (CSF) Platform consists of four laboratory-developed tests (LDTs) used for treatment selection and treatment monitoring of patients with Leptomeningeal Metastases (LM) from carcinomas or melanoma. The CNSide platform facilitates tumor cell detection/enumeration and biomarker identification using cellular assays (immunocytochemistry (ICC) and fluorescence in situ hybridization (FISH)) and molecular assays (next-generation sequencing (NGS)). The CNSide CSF tumor cell enumeration LDT is currently being used in the ReSPECT-LM trial as an exploratory endpoint and will be commercially available in 2025. The product is intended “For Research Use Only. Not for Use in Diagnostic Procedures.” RUO products cannot make any claims related to safety, effectiveness or diagnostic utility, and they cannot be intended for human clinical diagnostic use.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs, including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.
These statements include, without limitation, statements under the heading Upcoming Events and Expected Milestones, and statements regarding the following: CLIA compliance certification of the Company’s Houston-based clinical laboratory; the potential promise of rhenium (186Re) obisbemeda; expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates; the Company’s clinical trials, including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC clinical trials; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts;; development and utility of CNSide leptomeningeal metastases diagnostic test.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, including the ability of the Company to come into compliance with The Nasdaq Capital Market listing requirements; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
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