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Houston, TX – January 28, 2020 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced that Anthem Biosciences of Bangalore, India (Anthem) has completed a pilot run of the recrystallization of the Reata Pharmaceuticals, Inc. API (Reata). It has also completed a lyophilization of the API. Samples of the drug product, which include 299 capped vials have been shipped to Intertek Pharmaceutical Services (Intertek) for further analysis and release.
As previously announced, the FDA agreed in a preclinical submission that CNS could use Reata API as long as it was reprocessed and released under GMP conditions, and that the new lyophilized form of the drug product could be used during the Company’s upcoming clinical trial. Anthem, a full-service provider of GMP manufacturing for APIs, completed this pilot run of the Reata API. The pilot run recrystallization passed all specifications at Intertek. The recrystallized API was shipped to Lyophilization Technology, Inc. a leader of GMP lyophilization of Drug Products for clinical trials, which completed a pilot lyophilization. The pilot run of lyophilized API was successfully tested and released by Intertek. DavosPharma, a Davos Chemical Company, acted on behalf of the Company as the coordinating manufacturing broker for all of these processes.
“We are excited to achieve another important milestone in the development of Berubicin,” stated John Climaco, CEO of CNS Pharmaceuticals. “We look forward to completing both GMP manufacturing processes and release for clinical trials.”
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.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is proposed for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as for pancreatic and ovarian cancers, and lymphomas. The Company entered into an intellectual property (IP) agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata. For more information, visit www.cnspharma.com.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to receive a COA for the GMP reprocessed API, and to achieve the large-scale production of Berubicin. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
Source: CNS Pharmaceuticals, Inc.
This Additional Production Will Ensure Availability Through the Completion of its Upcoming Phase II Clinical Trials
Houst, TX – January 14, 2020 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced it has signed a contract with NCK A/S for the large scale production of Berubicin, its lead drug candidate for the treatment of glioma brain tumors.
NCK A/S is a GMP manufacturer of complex drugs located in Farum, Denmark, and the previous producer of Berubicin for Reata Pharmaceuticals. Production of large scale Berubicin is set to commence in January and will ensure drug availability through the end of Phase II clinical trials for glioblastoma.
“We are extremely excited to have entered into a contract with NCK A/S. We believe working with an experienced company in the production of this class of anthracyclines is paramount given the complex chemistry and difficulty to produce very high purity for human use,” stated John Climaco, CEO of CNS Pharmaceuticals. “We are confident in NCK A/S’ ability to succeed in the large scale production of our lead candidate due to its extensive experience in Berubicin synthesis for previous clinical trials. This contract represents a key stride in the development of Berubicin and secures drug availability as we look forward not only to initiate but also expand Phase II clinical trials later this year.”
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 was developed at the MD Anderson Cancer Center (MDACC), which is the top ranked cancer center in the US, and largest cancer research and treatment facility in the world. 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.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is proposed for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as for pancreatic and ovarian cancers, and lymphomas. The Company entered into an intellectual property (IP) agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata. For more information, visit www.cnspharma.com.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to prepare its IND and to commence its upcoming potential Phase II study. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
jsalierno@theruthgroup.com
kbrosco@theruthgroup.com
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
kthomas@theruthgroup.com
SOURCE: CNS Pharmaceuticals, Inc.
Houston, TX – January 13, 2020 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced it has entered into a licensing agreement with MD Anderson to investigate WP1244, an entirely new class of DNA-binding agents designed to cross the blood brain barrier for the potential the treatment of primary and metastatic brain cancers.
This agreement marks the Company’s first direct relationship with MD Anderson, the largest cancer research and treatment institute in the world, and allows for the continued development of WP1244, a new class of DNA-binding agents shown to have high anti-tumor activity. WP1244 was designed using a “modular” strategy, which combines intercalation and groove-binding modes into molecules with the requisite chirality and binding-site size to impart meaningful selectivity. Previous pre-clinical tests have demonstrated the agent’s ability to cross the blood barrier in animal models with no acute clinically observable toxicity. The Company is currently collaborating with MD Anderson on terms to conduct a sponsored research agreement of this novel class of agent.
“Our licensing agreement with MD Anderson has allowed CNS to double its portfolio with the addition of WP1244. We are extremely excited to continue the investigation of this entirely new class of DNA-binding agent in our first direct relationship with MD Anderson,” stated CEO of CNS, John M. Climaco. “We believe the compound demonstrates enormous potential through its novel mechanism of action, ability to cross the blood-brain barrier, and tremendous potency, 500 times that of classic DNA binding agents such as daunorubicin. WP1244 has shown to be mechanistically and biologically novel and selective, and its addition to our pipeline furthers our goal of being the leading developer of organ-targeted cancer therapeutics. We look forward to both furthering the clinical development of WP1244 and deepening our relationship with MD Anderson through a sponsored research agreement.”
About WP1244
WP1244 is a novel DNA binding agent with relatively high molecular weight (981.3 MW) having a polyamide moiety attached to the amino sugar. WP1244 is exceedingly potent having in vitro IC50 values in the subnanomolar range and is currently being studied for its therapeutic potential in preclinical studies. A previous 5-mice pilot study performed with WP1244 confirmed the presence of WP1244 in murine brain tissue. WP1244 was designed utilizing a “modular” design strategy, which combines intercalation and groove-binding modes into molecules with the requisite chirality and binding-site size to impart meaningful selectivity. Pre-clinical studies of WP1244 have demonstrated its potential ability to cross the blood-brain barrier in animal models. WP1244 was developed at the MD Anderson Cancer Center in the Department of Experimental Therapeutics as a collaborative effort with the Neuro-Oncology Department and Pharmaceutical Development Center.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is proposed for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as for pancreatic and ovarian cancers, and lymphomas. The Company entered into an intellectual property (IP) agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata. For more information, visit www.cnspharma.com.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to further the clinical development of WP1244. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
jsalierno@theruthgroup.com
kbrosco@theruthgroup.com
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
kthomas@theruthgroup.com
Source: CNS Pharmaceuticals, Inc.
Houston, TX – December 17, 2019 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced the completed good manufacturing practice (GMP) reprocessing of its lead drug candidate, Berubicin, with partner Anthem Biosciences Pvt. Ltd. of Banglaore, India, (“Anthem”) an internationally recognized Contract Research and Innovation Service Provider specializing in complex medicinal chemistry.
This critical manufacturing step was undertaken pursuant to previously announced positive feedback from the U.S. Food and Drug Administration (FDA) for the Company’s Pre-IND (Investigational New Drug) meeting proposal to use a lyophilized drug product, Berubicin, in Phase II clinical trials.
In its response to the Company’s Pre-IND request, the FDA agreed that CNS’ proposal to use a lyophilized drug product, that was developed previously but not used clinically, is acceptable. The FDA further stated that the Company’s proposal to utilize its existing supply of Berubicin in its proposed Phase 2 clinical trial was reasonable if the Berubicin was reprocessed by batch GMP recrystallization and released under GMP specifications. In response to the FDA’s guidance, CNS contracted with Anthem and completed the GMP reprocessing of CNS’ existing supply of Berubicin.
“We are thankful to have such an experienced partner, Anthem, assist us in completing the critical reprocessing work of our existing Berubicin supply,” stated CEO of CNS, John M. Climaco. “The GMP reprocessing was a significant milestone in our continued efforts to prepare a new IND in accordance with the FDA guidance we received. We look forward to our upcoming potential Phase II trial evaluating the efficacy of Berubicin in subjects who have glioblastoma that has recurred or progressed following radiation therapy and temozolomide, as we believe in Berubicin’s potential to demonstrate in clinical trials that it can become the only effective anthracycline against brain cancer.”
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 a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as pancreatic and ovarian cancers, and lymphomas. The Company entered into an IP agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata Pharmaceuticals, Inc. For more information, visit www.cnspharma.com
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to prepare its IND and to reprocess its existing supply of Berubicin ahead of its upcoming potential Phase II study. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
Source: CNS Pharmaceuticals, Inc.
Houston, TX – December 11, 2019 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, announced that its partner, WPD Pharmaceuticals (“WPD”), a Polish corporation founded by Dr. Waldemar Priebe, the founder of the Company, was awarded a $5,798,875 grant from the EU/Polish National Center for Research and Development under the Smart Growth Operational Program 2014-2020 (the “EU Grant”).
The Company previously entered into a sublicense agreement with WPD, in which WPD committed to a $2.0 million minimum expenditure on the development, testing, regulatory approval, and commercialization of Berubicin over a three –year period. WPD’s subsequent development project, “New approach to glioblastoma treatment addressing the critical unmet medical need” (the “WPD Project”), received the grant co-financed by the European Union under the Smart Growth Operational Program 2014-2020, Priority I: Support for Research and Development work by Enterprises, Measure 1.2: Sectorial Research and Development Programs, Sectorial Program InnoNeuroPharm. The main goal of the WPD Project is to implement the world’s first multicenter pediatric Phase I clinical trial to determine maximum tolerated dose (MTD) and Phase IB and II clinical trials in adults, to assess the efficacy of Berubicin. Proceeds from the grant will be used independently by WPD Pharmaceuticals in order to fulfill its commitment arising from its sublicense agreement with the Company.
“The EU Grant represents an important milestone for the advancement of our novel anthracycline, Berubicin, especially in pediatric settings,” commented CEO of CNS, John M. Climaco. “We believe this grant will allow our partner, WPD Pharmaceuticals, to fulfill its commitment arising from its sublicense agreement with us in a manner that is capital-efficient and non-dilutive to the CNS. Additionally, this EU Grant and our partnership with WPD presents an opportunity to potentially accelerate our efforts to bring Berubicin to patients around the world.”
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 a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as pancreatic and ovarian cancers, and lymphomas. The Company entered into an IP agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata Pharmaceuticals, Inc. For more information, visit www.cnspharma.com
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WPD to ultimately receive awarded grant funding and to conduct clinical trials to determine the maximum tolerated dose and to determine the efficacy of Berubicin in adults and the ability of WPD to spend the required minimum expenditure. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
Source: CNS Pharmaceuticals, Inc.
Houston, TX – December 10, 2019 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, received positive feedback from the U.S. Food and Drug Administration (FDA) for its Pre-IND (Investigational New Drug) meeting proposal to use a lyophilized drug product, Berubicin, in Phase II clinical trials.
In its positive response to the Company’s previously submitted Pre-IND request, the FDA indicated that the proposal to use a lyophilized drug product in the Phase II clinical trial appears reasonable. The FDA recommended that the existing supply of Berubicin be reprocessed by batch recrystallization. Furthermore, the FDA noted that the requested dosage regimen, which will be based on the Reata Phase I trial, was reasonable. The Company plans to reprocess its existing supply of Berubicin ahead of its upcoming potential Phase II study.
“We were encouraged by the initial feedback provided by the FDA as we believe the availability of our existing supply of Berubicin for a Phase II trial represents significant costs savings and eliminates excess risk and time,” stated CEO of CNS, John M. Climaco. “We are continuing the process of preparing a new IND in accordance with the guidance we received from the FDA. We look forward to our upcoming potential Phase II trial evaluating the efficacy of Berubicin in subjects who have glioblastoma that has recurred or progressed following radiation therapy and temozolomide as we believe in Berubicin’s potential to offer oncologists the only anthracycline effective against brain cancer.”
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 a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as pancreatic and ovarian cancers, and lymphomas. The Company entered into an IP agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata Pharmaceuticals, Inc. For more information, visit www.cnspharma.com
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company to prepare its IND and to reprocess its existing supply of Berubicin ahead of its upcoming potential Phase II study . These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
Source: CNS Pharmaceuticals, Inc.
Houston, TX – November 26, 2019 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, entered into a sublicense agreement with WPD Pharmaceuticals (“WPD”), a Polish corporation partially owned and controlled by Dr. Waldemar Priebe, the founder of the Company. The agreement grants WPD patent rights to research and develop, and manufacture or sell Berubicin in a limited territory comprised mainly of Eastern Europe and Central Asia. The Company is entitled to a 1% royalty on all commercial sales of Berubicin in these licensed territories.
As part of the agreement, WPD committed to a $2.0 million minimum expenditure on the development, testing, regulatory approval, and commercialization of Berubicin during the three year term of the agreement, which ends in August 2021. WPD plans to implement a multicenter pediatric Phase I clinical trial to determine maximum tolerated dose, and to determine the efficacy of Berubicin in Phase IB and II clinical trials in adults. WPD also plans to conduct preclinical tests to determine the prospective use of Berubicin with temozolomide and with other compounds as anticancer drugs.
“We were extremely excited to enter into an agreement with WPD and to further explore the potential of Berubicin as an anthracycline internationally,” commented CEO of CNS, John M. Climaco. “Our agreement with WPD is truly a testament to our unrelenting commitment to pursuing treatments for glioblastoma around the world.”
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 a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as pancreatic and ovarian cancers, and lymphomas. The Company entered into an IP agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata Pharmaceuticals Inc. For more information, visit www.cnspharma.com
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WPD to conduct clinical trials to determine the maximum tolerated dose and to determine the efficacy of Berubicin in adults, the ability of WPD to conduct preclinical tests to determine the prospective use of Berubicin with temozolomide and with other compounds as anticancer drugs, and the ability of WPD to spend the required minimum expenditure. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
Source: CNS Pharmaceuticals, Inc.
Houston, TX November 21, 2019 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, filed a Pre-IND meeting request for Berubicin for IV for the Treatment of Glioblastoma Multiforme to the US Food and Drug Administration Division of Oncology Products 2, Center for Drug Evaluation and Research.
In its request, the Company outlined its rationale for the continued investigation of the compound and detailed key questions for the FDA, including its permission to utilize the supply of Berubicin acquired from Reata Pharmaceuticals Inc. in the planned upcoming Phase II clinical trial. The company has performed a preliminary purity testing and analysis on Reata’s supply of Berubicin and verified that it is 99.9% pure.
“We believe that utilizing the supply of Berubicin we acquired from Reata could offer the Company significant costs savings and eliminate the excess risk and time associated with manufacturing complex drugs,” stated CEO of CNS, John M. Climaco.
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 a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as pancreatic and ovarian cancers, and lymphomas. The Company entered into an IP agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata Pharmaceuticals Inc. For more information, visit www.cnspharma.com
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of CNS to apply for and receive orphan drug status for Berubicin. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
Source: CNS Pharmaceuticals, Inc.
Houston, TX – November 19, 2019 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“Company”), a biotechnology company specializing in the development of novel treatments for brain tumors, completed an agreement with Houston Pharmaceuticals, Inc. (“HPI”) to obtain the rights to a worldwide, exclusive royalty-bearing, license for the chemical compound commonly known as Berubicin.
CNS’ licensing agreement with HPI grants the Company the exclusive right to develop certain patented chemical compounds for use in the treatment of cancer globally. In its agreement with HPI, the Company acquired multiple U.S. patents for Berubicin. CNS intends to apply for orphan drug status for Berubicin with the FDA for the treatment of malignant glioma.
“We believe our acquisition of the rights to Berubicin represents an important milestone in our pursuit to develop therapies for the treatment of glioblastoma, a type of brain cancer which is currently considered incurable,” stated CEO of CNS, John M. Climaco, Esq. “Our agreement with HPI expands our IP protection and provides us with developmental protection worldwide while we seek orphan drug status. We are excited to continue the clinical development of Berubicin and believe its promising tolerability and efficacy results are a testament to its therapeutic potential as a novel anthracycline agent.”
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 a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as pancreatic and ovarian cancers, and lymphomas. The Company entered into an IP agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata Pharmaceuticals Inc. For more information, visit www.cnspharma.com
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of CNS to apply for and receive orphan drug status for Berubicin. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under in our SEC filings, including under the heading “Risk Factors” in the Form S-1 we filed with the SEC on October 7, 2019. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7028 / 7032
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
Source: CNS Pharmaceuticals, Inc.
Houston, TX – November 13, 2019 – CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“Company”), a pre-clinical stage biotechnology company specializing in the development of novel treatments for brain tumors, today announced the closing of its initial public offering of 2,125,000 shares of common stock at an initial public offering price of $4.00 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by the Company, were $8.5 million. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 318,750 shares of common stock at the initial price to the public less underwriting discounts and commissions. The Company’s common stock is listed on the NASDAQ Capital Market under the symbol CNSP.
The Benchmark Company, LLC acted as sole Book Running Manager for the offering.
A registration statement on Form S-1 (File No. 333-232443) relating to the shares was filed with the Securities and Exchange Commission (“SEC”) and became effective on November 7, 2019. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from The Benchmark Company, LLC, Attn: Prospectus Department, 150 E 58th Street, 17th floor, New York, NY 10155, 212-312-6700, Email: prospectus@benchmarkcompany.com.
This press release shall not constitute an offer to sell or a 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 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 a pre-clinical stage biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as pancreatic and ovarian cancers, and lymphonas. The Company entered into an IP agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata Pharmaceuticals Inc. For more information, visit www.cnspharma.com
Investor Relations Contact
James Salierno / Kait Brosco
The Ruth Group
646-536-7000
jsalierno@theruthgroup.com
kbrosco@theruthgroup.com
Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
kthomas@theruthgroup.com
SOURCE CNS Pharmaceuticals, Inc.
About CNS Pharmaceuticals
CNS Pharmaceuticals is a pre-clinical stage biotechnology company specializing in the development of novel treatments for brain tumors.
Our lead drug, Berubicin, is an exciting discovery for the treatment of Glioblastoma Multiforme (GBM) and potentially for other CNS malignancies. Berubicin was first discovered at the MD Anderson Cancer Center, one of the largest cancer institutes in the world.
CNS has obtained a worldwide exclusive license to the Berubicin patent from Houston Pharmaceuticals, the original commercial holder of the Berubicin intellectual property.
CNS has also acquired all data and know-how related to the Phase 1 trial of Berubicin from Reata Pharmaceuticals, a multibillion dollar NASDAQ listed company. In 2017, CNS entered into a collaboration agreement with Reata to further advance the development of Berubicin.
In 2020, with the funding secured from our NASDAQ IPO, CNS will commence its Phase 2(a) clinical trial of Berubicin for the treatment of GBM.
CNS may also pursue the development of Berubicin to treat additional diseases, including pancreatic and ovarian cancers and lymphoma. CNS may also develop combination therapies that include Berubicin.
Berubicin
Based on human clinical trial data, our lead drug called Berubicin, which was developed at the M.D. Anderson Cancer Center, the largest cancer treatment and research institute in the world, has been shown to get across the blood brain barrier and kill brain tumor cells not reachable by other therapies. In other words, Berubicin may become an effective treatment against glioblastoma, the most aggressive type of brain cancer.
BERUBICIN PHASE I CLINICAL TRIAL
This is a scan of a patient’s glioblastoma in Berubicin’s Phase 1 clinical trial where 44% of the patients showed a clinical response. Berubicin is one of the first anthracycline’s that does not require a specific carrier to be able to cross over the blood brain barrier and get into the brain. None of the drugs that require carriers have been shown to be effective in humans.
What is Glioblastoma?
Glioblastoma is the most aggressive type of brain cancer, where the average survival is only 14 to 16 months after diagnosis – essentially a death sentence for those afflicted with it. Glioblastoma is the type of brain cancer that led to the death of Senator Ted Kennedy, Vice President Joe Biden’s son and most recently, the passing of Senator John McCain. It’s important to understand that there is currently no proven cure for this aggressive disease.
What are Anthracyclines?
Anthracyclines are among the most effective anticancer treatments ever developed, and have played a prominent role in the treatment of more types of cancer than any other class of chemotherapeutic agents. According to academic literature, Anthracyclines have demonstrated anti-tumor activity in a wide range of cancers including breast, stomach, uterine, ovarian, bladder, lung and hematological malignancies.
Source: https://cnspharma.com/
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