- GBM is diagnosed in more than 13,000 people each year in the US, with only a 12–18-month life expectancy
- Potentially pivotal Phase 2 trial of Berubicin is scheduled to commence around the end of Q1 2021
- The company is continuing its pre-clinical work on WP1244 during 2021 and 2022
- CNS Pharmaceuticals participated in two virtual conferences during March, spreading awareness about Berubicin and the GBM indicator
CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company specializing in developing novel treatments for primary and metastatic cancers of the brain and central nervous system, recently announced multiple value-driving milestones for its lead drug candidate Berubicin, a novel therapy targeting glioblastoma multiforme (“GBM”), as well as for its other drug candidate, WP1244, which targets several types of cancer (https://ibn.fm/y1XfB).
Glioblastoma Multiforme (“GBM”) is one of the most aggressive and deadly treatment-resistant cancers of the brain. GBM can affect a patient’s cognition, mood, behavior, and organ function. After diagnosis, the average life expectancy is 12-18 months resulting in close to 10,000 deaths annually in the United States. Every year, more than 13,000 new cases are diagnosed, making GBM 48% of all primary malignant brain tumors (https://ibn.fm/Z27t2).
Berubicin, one of two lead programs initially developed by Dr. Waldemar Priebe, a Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center, is a novel anthracycline that is the first anthracycline to cross the blood-brain barrier and is designed to concentrate in tumorous tissue within the brain. Berubicin is currently entering a potentially pivotal Phase 2 study for GBM treatment commencing around the end of Q1 2021. Two grant-funded studies are also scheduled to commence in Poland through WPD Pharmaceuticals, a sub-licensee partner of CNS Pharmaceuticals. The Phase 2 adult trial for GBM is expected to commence during Q2 2021 and the first-ever pediatric trial of Berubicin for malignant gliomas is expected to commence during H2 2021.
In its updated investor presentation, CNS Pharmaceuticals outlines several value-driving milestones for Berubicin that are expected to take place during 2021. These milestones include:
- Entering three clinical trials during 2021, including the potentially pivotal Phase 2 study commencing around the end of Q1 2021
- The interim data from WPD’s trial in Poland of Berubicin in adult GBM is expected during Q4 2021-Q1 2022
- Multiple growth opportunities exist with the WP1244 program and the expansion into other indications
CNS Pharmaceuticals’ other drug candidate currently in development, WP1244, is a DNA-binding agent believed to be 500-times more potent than daunorubicin in inhibiting tumor cell proliferation. The current target indications for WP1244 include brain cancers, pancreatic cancers, ovarian cancers, and lymphoma. Preclinical studies show high uptake in the brain with antitumor activity. There is currently a sponsored research agreement between CNS Pharmaceuticals and The University of Texas MD Anderson Cancer Center for this drug candidate. Pre-clinical work on WP1244 will continue during 2021 and 2022.
Additionally, there is discussion of expanding Berubicin into other cancer treatment fields. The indications that are being explored include:
- Primary Brain Tumors
- Relapsed High-Grade Gliomas – estimated population 15,000
- Brain Metastases-Combination with Radiation Therapy
- Small Cell Lung Cancer – estimated population 56,500
- Non-Small Cell Lung Cancer – estimated population 56,000
- Metastatic Breast Cancer – estimated population 45,000
- CNS Lymphoma
- Second line treatment after Methotrexate failure – estimated population 1,200
CNS Pharmaceuticals’ latest investor presentation also outlines several financial highlights. Notable achievements financially include the November 7, 2019, $9.8 million IPO, a $14 million cash balance as of December 31, 2020, and around 23.9 million shares outstanding. Based on a 10-day average of March 12, 2021, the company has a market cap around $58 million with an average volume of around 347,000.
To further advance and raise awareness of its novel therapies, CNS Pharmaceuticals attended two prominent virtual conferences in March 2021: H.C. Wainwright Global Life Sciences Conference (March 9-10) and was the inaugural Emerging Growth Virtual Conference presented by M Vest LLC and Maxim Group LLC (March 17-18). On the sidelines of the H.C. Wainwright Global Life Sciences Conference, CEO John Climaco also had the opportunity to participate in one-on-one meetings with qualified investors, while at the Emerging Growth Virtual Conference he also participated in a live glioblastoma panel discussion.
For more information, visit the company’s website at www.CNSPharma.com.
NOTE TO INVESTORS: The latest news and updates relating to CNSP are available in the company’s newsroom at https://ibn.fm/CNSP
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