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CNS Pharmaceuticals, Inc. - CNSP STOCK NEWS

Welcome to our dedicated page for CNS Pharmaceuticals news (Ticker: CNSP), a resource for investors and traders seeking the latest updates and insights on CNS Pharmaceuticals stock.

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) is a Houston-based clinical-stage biopharmaceutical company established in 2017. The company is dedicated to developing novel anticancer drug candidates aimed at treating primary and metastatic cancers of the brain and central nervous system (CNS). Their lead drug candidate, Berubicin, is a pioneering anthracycline that distinguishes itself by its ability to cross the blood-brain barrier, offering new hope for patients suffering from glioblastoma multiforme (GBM), an aggressive and currently incurable form of brain cancer.

Berubicin has shown promise in initial trials, with the Phase I clinical trial completing successfully. As of now, Berubicin is being evaluated in a potentially pivotal study. The preliminary safety data was presented at the Society of NeuroOncology (SNO) 28th Annual Meeting, highlighting its comparability in patient demographics and safety with the control arm of the study. Encouragingly, the independent Data Safety Monitoring Board (DSMB) recommended the continuation of the trial without modification after a pre-planned interim futility analysis, signifying Berubicin’s acceptable efficacy and safety profile.

The company has also secured several important collaborations and licensing agreements, including partnerships with Houston Pharmaceuticals, Inc., the University of Texas M.D. Anderson Cancer Center, and WPD Pharmaceuticals Inc. These agreements bolster the development pipeline and provide access to cutting-edge research and development facilities.

Financially, CNS Pharmaceuticals is proactive in securing necessary funding for their research endeavors. Recent public offerings and strategic financial management have ensured operational continuity and support for their ongoing clinical trials. Despite the inherent risks and uncertainties of drug development, CNS Pharmaceuticals remains steadfast in their mission to develop effective cancer therapies.

Beyond Berubicin, CNS Pharmaceuticals continues to explore additional drug candidates and therapies to address various CNS oncology indications. The company's commitment to innovation and patient care positions it as a potential leader in the fight against some of the most challenging cancer types.

For more information, please visit www.CNSPharma.com and connect with the company on Twitter, Facebook, and LinkedIn.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) has initiated its first clinical trial sites in Europe, specifically in France and Spain, for the global study evaluating Berubicin against recurrent glioblastoma multiforme (GBM), a severe brain cancer. Currently, 26 of 59 planned sites are open across various countries including the U.S. and Italy. This potentially pivotal trial aims to assess Berubicin's efficacy compared to Lomustine, with Overall Survival as the primary endpoint. The FDA has granted Berubicin Fast Track and Orphan Drug Designation, facilitating expedited development.

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CNS Pharmaceuticals (NASDAQ: CNSP) will host a live moderated video webcast on September 28, 2022, at 1:00 PM ET to discuss its pivotal global study of Berubicin for treating glioblastoma multiforme (GBM). This adaptive, multicenter trial aims to assess the drug’s efficacy and safety in patients with recurrent GBM following standard therapy failure, focusing on overall survival as the primary endpoint. An interim analysis will evaluate safety and efficacy after 30-50% of patients complete the study. The event will allow audience questions.

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CNS Pharmaceuticals (NASDAQ: CNSP) announced that CEO John Climaco will present at the H.C. Wainwright 24th Annual Global Investment Conference in New York from September 12-14, 2022. A video webcast of the presentation will be available on-demand starting September 12 at 7:00 AM ET and archived for 90 days. CNS Pharmaceuticals focuses on developing innovative cancer treatments, including its lead drug Berubicin, which targets brain cancers. The company will also participate in virtual one-on-one meetings with qualified investors during the conference.

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CNS Pharmaceuticals reported its Q2 2022 financial results, posting a net loss of approximately $3.6 million, an improvement from $3.8 million in Q2 2021. The company continues to execute on its clinical operations for Berubicin, a drug being evaluated in a pivotal global trial for Glioblastoma Multiforme (GBM). Currently, 23 out of 54 clinical trial sites are operational across the U.S. and Europe, with European enrollment expected soon. The company maintains a cash position of $9.0 million, expected to fund operations into 2023.

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CNS Pharmaceuticals (NASDAQ: CNSP) is urging shareholders to vote in favor of two proposals at the upcoming Annual Shareholder Meeting on July 27, 2022. The proposals seek authorization to increase the number of shares available for issuance and allow the Board to conduct a reverse stock split at a ratio between 1-for-2 and 1-for-30. CEO John Climaco emphasized the necessity of these measures to secure financing and maintain the NASDAQ listing amidst challenging market conditions, while stressing that such actions will only be undertaken if truly needed.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) announced FDA approval for a protocol amendment to its global trial on Berubicin, targeting recurrent glioblastoma multiforme (GBM). The trial has expanded patient eligibility to those who have undergone multiple first-line therapies. With 19 clinical sites currently active and an additional 42 set to open in Europe and the U.S., the company aims to enhance patient access. A non-binding futility analysis will occur after 30-50% of subjects complete six months, without pausing enrollment. Berubicin, noted for crossing the blood-brain barrier, demonstrates potential in treating aggressive brain cancer.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) recently presented an overview of its ongoing clinical trial for Berubicin, aimed at treating recurrent glioblastoma multiforme (GBM), at the ASCO 2022 Annual Meeting. Berubicin, the first anthracycline to cross the blood-brain barrier, demonstrated greater cytotoxicity compared to doxorubicin in GBM cell lines. The ongoing global study involves 243 patients and assesses Berubicin's efficacy against Lomustine. Positive feedback from European regulatory authorities enhances confidence in the trial's design, which aims to address significant unmet medical needs in GBM treatment.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) announced CEO John Climaco's participation in the H.C. Wainwright Global Investment Conference from May 23-26, 2022, in Miami. A video of the presentation will be available for on-demand viewing for registered attendees. CNS is focused on developing novel treatments for brain and central nervous system cancers, including their lead drug candidate, Berubicin, which crosses the blood-brain barrier. The company is also advancing the WP1244 drug technology, showcasing promising preclinical results against various cancers.

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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) announced that its abstract was accepted for presentation at the ASCO 2022 Annual Meeting, taking place from June 3-7, 2022 in Chicago, IL. The poster titled 'Design and initiation of an adaptive, randomized, controlled study of berubicin for recurrent glioblastoma multiforme' will be presented by Dr. Sandra L. Silberman on June 5, 2022. Berubicin is noted as the first anthracycline able to cross the blood-brain barrier and aims to treat aggressive brain cancers. This represents a significant milestone in CNSP's development of innovative cancer therapies.

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CNS Pharmaceuticals (CNSP) announced financial results for Q1 2022, reporting a net loss of approximately $2.8 million, down from $3.6 million year-over-year. The company is expanding its Berubicin study in Switzerland, France, and Spain, aiming to enhance patient enrollment in the pivotal trial for glioblastoma multiforme (GBM). Berubicin has received Fast Track and Orphan Drug Designation from the FDA, potentially accelerating its development. CNSP also has cash on hand of around $12.4 million, expected to fund operations into Q1 2023.

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FAQ

What is the current stock price of CNS Pharmaceuticals (CNSP)?

The current stock price of CNS Pharmaceuticals (CNSP) is $0.1149 as of December 26, 2024.

What is the market cap of CNS Pharmaceuticals (CNSP)?

The market cap of CNS Pharmaceuticals (CNSP) is approximately 6.6M.

What is CNS Pharmaceuticals' primary focus?

CNS Pharmaceuticals specializes in developing novel treatments for primary and metastatic cancers in the brain and central nervous system.

What is Berubicin?

Berubicin is CNS Pharmaceuticals' lead drug candidate, a novel anthracycline designed to treat glioblastoma multiforme (GBM) and other serious brain cancers by crossing the blood-brain barrier.

What makes Berubicin different from other cancer treatments?

Berubicin is the first anthracycline to appear to cross the blood-brain barrier, potentially making it more effective against brain cancers compared to traditional chemotherapy drugs.

What stage is Berubicin currently in?

Berubicin is currently undergoing a potentially pivotal study, with promising interim safety results and a recommendation to continue the trial without modification.

What recent achievements has CNS Pharmaceuticals reported?

CNS Pharmaceuticals recently completed planned enrollment for its Berubicin trial, received DSMB's recommendation to continue the study without modification, and announced positive interim safety data.

Who are CNS Pharmaceuticals' key partners?

CNS Pharmaceuticals has partnerships with Houston Pharmaceuticals, Inc., the University of Texas M.D. Anderson Cancer Center, and WPD Pharmaceuticals Inc.

What financial steps has CNS Pharmaceuticals taken recently?

CNS Pharmaceuticals has conducted public offerings to secure funding for its ongoing clinical trials and research and development efforts.

What designations has the FDA granted to Berubicin?

The FDA has granted Berubicin Fast Track Designation, enabling more frequent interactions for expediting development, and Orphan Drug Designation, which may provide seven years of marketing exclusivity upon approval.

What is the primary endpoint of the Berubicin study?

The primary endpoint is Overall Survival (OS), which the FDA recognizes as a basis for oncology drug approval when a statistically significant improvement is shown.

How does CNS Pharmaceuticals ensure the accuracy and safety of its trials?

CNS Pharmaceuticals relies on an independent Data Safety Monitoring Board (DSMB) to review interim data and ensure the safety and efficacy of its clinical trials.

CNS Pharmaceuticals, Inc.

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