CNS Pharmaceuticals, Inc. (NASDAQ:CNSP)

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CNS Pharmaceuticals Entered $2.0 Million Dollar Sublicense Agreement with WPD Pharmaceuticals

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

jsalierno@theruthgroup.com 

kbrosco@theruthgroup.com

 

Media Contact

Kirsten Thomas

The Ruth Group

(508) 280-6592

kthomas@theruthgroup.com

 

Source:  CNS Pharmaceuticals, Inc.

CNS Pharmaceuticals Filed Request with FDA for Pre-IND Meeting for Berubicin

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

jsalierno@theruthgroup.com 

kbrosco@theruthgroup.com

 

Media Contact

Kirsten Thomas

The Ruth Group

(508) 280-6592

kthomas@theruthgroup.com

 

Source:  CNS Pharmaceuticals, Inc.

CNS Pharmaceuticals Acquired Worldwide Rights for Brain Cancer Drug from Houston Pharmaceuticals

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

jsalierno@theruthgroup.com 

kbrosco@theruthgroup.com

 

Media Contact

Kirsten Thomas

The Ruth Group

(508) 280-6592

kthomas@theruthgroup.com

 

Source:  CNS Pharmaceuticals, Inc.

CNS Pharmaceuticals Announces Closing Of Initial Public Offering of Common Stock

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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This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may”, “future”, “plan” or “planned”, “will” or “should”, “expected,” “anticipates”, “draft”, “eventually” or “projected”. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company’s annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNMG undertakes no obligation to update such statements.

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