CNS Pharmaceuticals reports financial results for the first quarter of 2021 and provides business perspectives

CNS Pharmaceuticals reports financial results for the first quarter of 2021 and provides business perspectives

Commence patient enrollment in potentially pivotal study to evaluate efficacy of Berubicin in the treatment of adult GBM in Q2 2021;
WPD Pharmaceuticals to initiate a Phase 2 multicenter clinical trial of Berubicin in GBM in the second half of 2021;
The WPD trial interim analysis of the first 18 patients by Q1-Q2 2022 for efficacy as well as an extensive pharmacokinetic profile in these patients;
CNS Pharmaceuticals to report interim analysis of U.S. adult GMB trial when 50% of planned subjects reach 6 months in study;
WPD will commence a multicenter Phase 1 pediatric trial for malignant CNS tumors in 2021;
CNS will conduct pre-clinical evaluation of Berubicin for additional CNS cancers and cancers metastatic to the brain, including development of potential combination therapies for these indications; and
CNS Pharmaceuticals to expand pipeline in the evaluation of other drugs for brain cancers. Anticipated Upcoming Milestones: The FDA has granted CNS Pharmaceuticals Orphan Drug Designation for Berubicin, which provides seven years of marketing exclusivity upon approval of an NDA. CNS Pharmaceuticals intends to file for additional patents relating to Berubicin to further secure intellectual property protections.

CNS’ lead product candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications. The Company expects to commence patient enrollment in its potentially pivotal study evaluating the efficacy of Berubicin in the treatment of adult GBM in the second quarter. For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069. Berubicin – Novel anthracycline

In addition to the Company’s global trial, sublicensee partner in Poland, WPD Pharmaceuticals, will initiate a Phase 2 multicenter clinical trial of Berubicin in GBM in the second half of 2021 and report an interim analysis of the first 18 patients by Q1-Q2 2022. Clinical Programs Update

Summary of Financial Results for First Quarter 2021 The net loss for the three months ended March 31, 2021 was approximately $3.6 million compared to approximately $2.0 million for the comparable period in 2020. The change in net loss is attributable to increased personnel and activity associated with preparing for the Company’s clinical trials in 2020. The Company reported Research and development expenses of $2.2 million for the three months ended March 31, 2021 compared to approximately $0.6 million for the comparable period in 2020. The expenses incurred during the period were related to drug manufacturing and labor related to the preparation of our Phase 2 study. General and administrative expense was approximately $1.4 million for the three months ended March 31, 2021 compared to approximately $1.3 million for the comparable period in 2020. The Company ended the quarter with $11.0 cash and cash equivalents, expected to fund operations into 2022. Anticipated Upcoming Milestones

The Company continues to advance the development of its WP1244 drug technology, which utilizes anthracycline and distamycin-based scaffolds to create small molecule agents and is believed to be 500x more potent than daunorubicin in inhibiting tumor cell proliferation. Preclinical studies of WP1244 demonstrated high uptake in the brain with antitumor activity. CNS Pharmaceuticals is evaluating the use of WP1244 in the treatment of brain cancers, pancreatic, ovarian, and lymphomas. WP1244 Portfolio – Novel class of DNA-binding agents

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