On November 14, 2022 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported its financial results for the quarter ended September 30, 2022 and provided a clinical update of its anti-cancer drug candidates currently in development for the treatment of primary and metastatic brain and CNS cancer (Press release, CNS Pharmaceuticals, NOV 14, 2022, View Source [SID1234624055]).
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"In the past quarter, we successfully expanded our potentially pivotal Berubicin trial into Europe with a number of clinical sites initiated and most recently the initiation of patient enrollment and dosing in France. This expansion into Europe drives us toward our goal of interim analysis, expected in mid-2023, which we believe has the potential to be transformational milestone. Moving forward, we are focused on building momentum and advancing this important program across the finish line," commented John Climaco, CEO of CNS Pharmaceuticals.
Berubicin Highlights
Ongoing potentially pivotal trial evaluating lead product candidate Berubicin for the treatment of recurrent glioblastoma multiforme (GBM)
Upcoming Milestones
Continued site initiations across the U.S., Italy, France, Spain, and Switzerland for potentially pivotal study to evaluate efficacy of Berubicin in the treatment of adult GBM;
Regulatory and ethics approval in Italy;
Interim analysis of the trial when 30-50% of the total expected patients have been on study for 6 months (expected mid-year 2023); and
Complete enrollment in potentially pivotal clinical trial for GBM.
The FDA has granted CNS Pharmaceuticals Fast Track Designation and Orphan Drug Designation for Berubicin. For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.
Summary of Financial Results for the Third Quarter 2022
The net loss for the three months ended September 30, 2022 was approximately $3.4 million compared to approximately $3.8 million for the comparable period in 2021. The change in net loss is primarily attributable to decreases due to the timing of drug development expenses (significant manufacturing activity occurred in the prior year period with much less occurring in the current year), as well as a credit to research and development expense for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their clinical trials, partially offset by an increase in CRO expenses related to continued progress with our potentially pivotal clinical trial of Berubicin as well as increases in legal and professional fees and other expenses..
The Company reported Research and development expenses of $2.2 million for the three months ended September 30, 2022 compared to approximately $2.6 million for the comparable period in 2021. The change in net loss is primarily attributable to the timing of drug development expenses (significant manufacturing activity occurred in the prior year period with much less occurring in the current year, and this lower level of manufacturing activity is expected to continue throughout this year), as well as a credit to research and development expense for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their clinical trials, partially offset by an increase in contract research organization (CRO) expenses related to continued progress with our potentially pivotal clinical trial of Berubicin..
General and administrative expense was approximately $1.2 million for the three months ended September 30, 2022 compared to approximately $1.2 million for the comparable period in 2021. This change is primarily due to decreases of approximately $204,000 for stock-based compensation, $46,000 in advertising and marketing, $32,000 in insurance and $31,000 in other expenses, which were offset by an increase of approximately $289,000 in legal and professional expenses.
As of September 30, 2022, the Company had cash of approximately $7.0 million and working capital of approximately $7.5 million. The Company’s current expectation is that the cash on hand and the proceeds from the offering during January is sufficient to fund our operations into the first quarter of 2023. The timing and costs of clinical trials are difficult to predict and trial plans may change in response to evolving circumstances and as such the foregoing estimates may prove to be inaccurate.