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CNS Pharmaceuticals, Inc. (CNSP)

NasdaqCM - NasdaqCM Real Time Price. Currency in USD
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1.7900-0.0500 (-2.72%)
As of 12:48PM EDT. Market open.
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Previous Close1.8400
Open1.7900
Bid1.7800 x 3000
Ask1.8000 x 1200
Day's Range1.7700 - 1.8200
52 Week Range1.5900 - 4.4600
Volume38,235
Avg. Volume360,470
Market Cap45.393M
Beta (5Y Monthly)N/A
PE Ratio (TTM)N/A
EPS (TTM)-0.6370
Earnings DateMar. 12, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est8.33
  • WPD Pharmaceuticals Announces Berubicin Supply Agreement for the Upcoming Clinical Trials
    GlobeNewswire

    WPD Pharmaceuticals Announces Berubicin Supply Agreement for the Upcoming Clinical Trials

    VANCOUVER, British Columbia, Feb. 24, 2021 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals (CSE:WBIO) (8SV1.F) ("WPD" or the “Company”) today announced that it has signed an agreement with CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) (“CNS”) to obtain Investigational Medicinal Product (“IMP”) for use in the planned clinical trials of Berubicin. WPD will purchase half of the batch previously manufactured for CNS by BSP Pharmaceuticals for the WPD-201 and WPD-201P studies which are planned to begin in the first half of 2021. This IMP will be QP certified by Clinigen Clinical Supplies Management on behalf of WPD under European current Good Manufacture Practice (“cGMP”) requirements. Berubicin is a novel anthracycline candidate for the treatment of a number of serious oncology indications including Glioblastoma Multiforme (GBM). WPD sublicensed Berubicin from CNS in November 2019, which provided WPD with the commercial rights to Berubicin in select territories primarily in eastern Europe and Asia. Mariusz Olejniczak, CEO of WPD comments, “This agreement will allow us to submit a complete application to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, which is the Polish equivalent of the FDA, to initiate the studies without any delay. We hope to receive approval within three months from submission, dependent on if we receive any questions or requests from the President of the Office.” Shortly after the sublicense agreement, WPD was awarded a reimbursement grant for further development of Berubicin valued at $6 million from the Polish National Center for Research and Development under Smart Growth Operational Program 2014-2020 co-financed by the European Union. WPD plans to initiate both a multicenter Berubicin Phase 2 trial in adult GBM in the first half of 2021 and a multicenter pediatric malignant glioma Phase 1 clinical trial in 2021. CNS Pharmaceuticals has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to proceed with their planned randomized and controlled Phase 2 trial of Berubicin in the treatment of adults with GBM who have failed first-line therapy, which is expected to commence in the first quarter of 2021. The FDA has also designated Berubicin an Orphan Drug. CNS has received Central IRB study-level approval for its GBM study. About Berubicin Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center. About WPD Pharmaceuticals WPD is a biotechnology research and development company with a focus on oncology and virology, namely research and development of medicinal products involving biological compounds and small molecules. WPD has licensed in certain countries 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at medical institutions, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland. WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain compounds for about 30 countries, mostly in Europe. Such agreements provide WPD with certain research, development, manufacturing and sales rights and obligations, among other things. For more information, please visit wpdpharmaceuticals.com. On Behalf of the Board ‘Mariusz Olejniczak’ Mariusz OlejniczakCEO, WPD Pharmaceuticals Contact: Investor RelationsEmail: investors@wpdpharmaceuticals.comTel: 604-428-7050Web: www.wpdpharmaceuticals.com Forward Looking Statements This document contains forward-looking statements. Forward-looking statements are statements that contemplate activities, events or developments that the Company anticipates will or may occur in the future. Forward-looking statements in this press release include timing for clinical trials for our drug candidates; that a large portion of our program budget will be refunded by research and other grants and that WPD’s drugs could be developed into novel treatments for cancer and other diseases. These forward-looking statements reflect the Company’s current expectations based on information currently available to management and are subject to a number of risks and uncertainties that may cause outcomes to differ materially from those projected. Factors which may prevent the forward looking statement from being realized is that competitors or others may successfully challenge granted patents and the patents could be rendered void; that we are unable to raise sufficient funding for our research; that we may not meet the requirements to receive the grants awarded; that our drugs don’t provide positive treatment, or if they do, the side effects are damaging; competitors may develop better or cheaper drugs; we may be unable to obtain regulatory approval for any drugs we develop; and we may otherwise be unable to carry out our business plans. Readers should refer to the risk disclosure included from time-to-time in the documents the Company files on SEDAR, available at www.sedar.com. Although the Company believes that the assumptions inherent in these forward-looking statements are reasonable, they are not guarantees of future performance and, accordingly, they should not be relied upon and there can be no assurance that any of them will prove to be accurate. Finally, these forward-looking statements are made as of the date of this document and the Company assumes no obligation to update them except as required by applicable law.

  • WPD and CNS Pharmaceuticals Announce Positive Opinion of the Polish Central Ethics Committee for the WPD-201 Study and Central IRB Study Level Approval for the CNS-201 Study
    GlobeNewswire

    WPD and CNS Pharmaceuticals Announce Positive Opinion of the Polish Central Ethics Committee for the WPD-201 Study and Central IRB Study Level Approval for the CNS-201 Study

    WPD Pharmaceuticals plans to initiate a Berubicin Phase 2 adult GBM trial in the first half of 2021 and a multicenter pediatric malignant glioma Phase 1 clinical trial in 2021 CNS Pharmaceuticals plans to initiate a Berubicin adult GBM trial in Q1 2021 HOUSTON, Feb. 18, 2021 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals (CSE:WBIO) (8SV1.F) ("WPD") and CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), biopharmaceutical companies specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that WPD Pharmaceuticals received a positive opinion of the Lower Silesian Medical Chamber Ethics Committee in Wrocław, Poland for its planned upcoming Berubicin clinical trial in adults with Glioblastoma Multiforme (GBM) under the WPD-201 Clinical Trial Protocol. CNS Pharmaceuticals has received study level Central IRB Approval from the Central IRB for the CNS-201 Clinical Trial Protocol. Berubicin is the Company’s novel anthracycline candidate for the treatment of a number of serious oncology indications, currently in development for the treatment of GBM. CNS entered into a sublicense agreement with WPD in November 2019, which provided WPD the commercial rights in select territories in Europe and Asia to Berubicin. Mariusz Olejniczak, CEO of WPD comments, “This is an important step for WPD from both a project and sublicense agreement point of view. After receiving the positive opinion from the Central Ethics Committee, we are planning to submit our application to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, which is the Polish equivalent of the FDA. We hope to receive approval within three months from submission, dependent on if we receive any questions or requests from the President of the Office. We are planning for our sites to start recruiting patients soon after approval is received. Information about our sites will be published both on clinicaltrials.gov and in the European database. During the review process, we will start preparing submissions to Ethic Committee and Competent Authority (equivalent of FDA) in one country outside of Poland.” “We are pleased for WPD to achieve this key milestone and are encouraged by their continued execution in furthering the development of Berubicin,” commented John Climaco, CEO of CNS Pharmaceuticals. “Importantly, we believe WPD’s Ethics Committee approval of the WPD-201 Clinical Trial Protocol coupled with our recent IND approval and Central IRB Study Level approval, position us one step closer to collaboratively initiating three clinical trials for Berubicin during 2021. We look forward to continuing our trial preparations, as well as WPD’s planned submissions to the Polish Competent Authority.” Following the sublicense agreement, WPD was subsequently awarded a reimbursement grant for further development of Berubicin that was valued at $6 million upon the date of the grant from the Polish National Center for Research and Development under Smart Growth Operational Program 2014-2020 co-financed by the European Union. WPD plans to initiate both a multicenter Berubicin Phase 2 adult GBM trial in the first half of 2021 and a multicenter pediatric malignant glioma Phase 1 clinical trial in 2021. Roughly 60% of the program budget is expected to be funded by the reimbursement grant. CNS Pharmaceuticals has received approval to proceed with their previously submitted Investigational New Drug (IND), from the U.S. Food and Drug Administration (FDA) for Berubicin in the treatment of GBM. The Company plans to initiate its Phase 2 trial evaluating the efficacy and safety of Berubicin in the treatment of adults with GBM who have failed first-line therapy in the first quarter of 2021. The Company has also received Central IRB study level approval for the U.S. portion of the adult GBM study. About Berubicin Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world's largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer. About CNS Pharmaceuticals, Inc. CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation. For more information, please visit www.CNSPharma.com. About WPD Pharmaceuticals WPD is a biotechnology research and development company with a focus on oncology and virology, namely research and development of medicinal products involving biological compounds and small molecules. WPD has licensed in certain countries 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at medical institutions, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland. WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain compounds for about 30 countries, mostly in Europe. Such agreements provide WPD with certain research, development, manufacturing and sales rights and obligations, among other things. For more information, please visit wpdpharmaceuticals.com. On Behalf of the Board ‘Mariusz Olejniczak’ Mariusz OlejniczakCEO, WPD Pharmaceuticals Contact: Investor RelationsEmail: investors@wpdpharmaceuticals.comTel: 604-428-7050Web: www.wpdpharmaceuticals.com Forward Looking Statements This document contains forward-looking statements. Forward-looking statements are statements that contemplate activities, events or developments that the Company anticipates will or may occur in the future. Forward-looking statements in this press release include timing for clinical trials for our drug candidates; that a large portion of our program budget will be refunded by research and other grants and that WPD’s drugs could be developed into novel treatments for cancer and other diseases. These forward-looking statements reflect the Company’s current expectations based on information currently available to management and are subject to a number of risks and uncertainties that may cause outcomes to differ materially from those projected. Factors which may prevent the forward looking statement from being realized is that competitors or others may successfully challenge granted patents and the patents could be rendered void; that we are unable to raise sufficient funding for our research; that we may not meet the requirements to receive the grants awarded; that our drugs don’t provide positive treatment, or if they do, the side effects are damaging; competitors may develop better or cheaper drugs; we may be unable to obtain regulatory approval for any drugs we develop; and we may otherwise be unable to carry out our business plans. Readers should refer to the risk disclosure included from time-to-time in the documents the Company files on SEDAR, available at www.sedar.com. Although the Company believes that the assumptions inherent in these forward-looking statements are reasonable, they are not guarantees of future performance and, accordingly, they should not be relied upon and there can be no assurance that any of them will prove to be accurate. Finally, these forward-looking statements are made as of the date of this document and the Company assumes no obligation to update them except as required by applicable law.

  • InvestorBrandNetwork Announces C3 Chat Show Podcast with CNS Pharmaceuticals Inc. Chairman and CEO John Climaco
    GlobeNewswire

    InvestorBrandNetwork Announces C3 Chat Show Podcast with CNS Pharmaceuticals Inc. Chairman and CEO John Climaco

    LOS ANGELES, Jan. 13, 2021 (GLOBE NEWSWIRE) -- via InvestorWire — InvestorBrandNetwork (“IBN”), a multifaceted financial news and publishing company for private and public entities, today announces that John Climaco, Chairman and CEO of CNS Pharmaceuticals Inc. (NASDAQ: CNSP), was recently interviewed on the C3 Chat Show Podcast, a series that addresses topics related to entrepreneurship, life experiences and best practices from experts. The podcast, co-hosted by Sid Vaidya and Eric Gershey, is available for on-demand listening at https://anchor.fm/c3chat.During the interview, Climaco provided an overview of CNS Pharmaceuticals and recent FDA approval to begin clinical trials on the company’s lead drug candidate, Berubicin, a proposed treatment for glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable.“This is the biggest news we’ve announced since our IPO back in November 2019. The FDA approved an Investigational New Drug application, which allows us to proceed with our clinical trial. Based on that IND approval, we expect, in the next 90 to 120 days, we will go from zero active clinical trials today to three active clinical trials for our lead compound, Berubicin, which is a novel treatment for glioblastoma, the most common and aggressive form of primary brain cancer,” Climaco said.“We have five employees at this company, so we are a tiny little shop,” he continued. “But we have an absolute powerhouse compound. We pushed that through and got the FDA to greenlight a clinical trial, which is really monumental. The Food and Drug Administration of the United States said it’s safe to proceed and investigate this drug in humans.”“It’s a big day for GBM patients. This is a population that has not seen hardly any innovation for 15 years,” he said. “If you get GBM, the sad reality is you’re probably going to die from it. We think we can change that game.”“We expect to be enrolling patients as soon as January or February. We know how this drug behaves. It was the subject of a very successful Phase I trial where 44 percent of patients had their disease stabilized or they started to get better. Those are remarkable statistics, because GBM is the deadliest form of brain cancer. Basically no one gets better. But we have a patient who is still alive 14 years after treatment, and that’s just incredible because the median survival for GBM patients following diagnosis is 14-16 months.”Throughout the podcast, Climaco discussed the difficulties in treating brain cancers because of the brain’s protective covering of specialized cells that shield it from outside infection. He also explained how Berubicin is able to cross the blood-brain barrier and attack tumor cells inside the brain.Learn more by listening to the full interview at https://anchor.fm/c3chat.About CNS Pharmaceuticals Inc.CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.For more information, visit: www.cnspharma.comAbout InvestorBrandNetworkThe InvestorBrandNetwork (“IBN”) consists of financial brands introduced to the investment public over the course of 15+ years. With IBN, we have amassed a collective audience of millions of social media followers. These distinctive investor brands aim to fulfill the unique needs of a growing base of client-partners. IBN will continue to expand our branded network of highly influential properties, leveraging the knowledge and energy of specialized teams of experts to serve our increasingly diversified list of clients.Through NetworkNewsWire (“NNW”) and its affiliate brands, IBN provides: (1) access to a network of wire solutions via InvestorWire to reach all target markets, industries and demographics in the most effective manner possible; (2) article and editorial syndication to 5,000+ news outlets; (3) enhanced press release solutions to ensure maximum impact; (4) full-scale distribution to a growing social media audience; (5) a full array of corporate communications solutions; and (6) a total news coverage solution.For more information on IBN, visit https://www.InvestorBrandNetwork.com.Please see full terms of use and disclaimers on the InvestorBrandNetwork website, applicable to all content provided by IBN wherever published or re-published: https://IBN.fm/DisclaimerForward-Looking StatementsThis release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company's SEC filings. These risks and uncertainties could cause the company's actual results to differ materially from those indicated in the forward-looking statements.Corporate CommunicationsInvestorBrandNetwork (IBN) Los Angeles, California www.InvestorBrandNetwork.com 310.299.1717 Office Editor@InvestorBrandNetwork.com