Full Press Release Details
CNS Pharmaceuticals Reports Full Year 2021 Financial
Results and Provides Corporate Update
2021 marked by operational advancements on clinical
and regulatory fronts
Company continues to execute progression of
lead program, Berubicin, in ongoing potentially pivotal global clinical trial
Platform opportunities for expansion into additional
oncology indications with significant unmet needs
Closed on $11.5M private placement to advance
towards planned milestones
HOUSTON, TX (March 3, 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, today reported its financial results for the year
ended December 31, 2021 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.
"Operationally 2021 was a terrific year
for the Company as we established the global framework for building and expanding our potentially pivotal clinical study of berubicin
for the treatment of GBM. Our priority remains focused on advancing berubicin to bring a meaningful treatment to patients, families and
clinicians, who currently have extremely limited and often ineffective treatment options. I am continually impressed by the speed and
efficiency with which our small team has executed our Berubicin trial. At the onset of 2022 we completed a $11.5 million private placement
which enables us to continue driving the development of berubicin this year towards the milestones ahead of us," commented John
Climaco, CEO of CNS Pharmaceuticals. "While staying steadfast in our primary goal of bringing berubicin to GBM patients, we are
also continually evaluating platform opportunities for expansion into additional oncology indications to bolster our pursuit of therapies
for patients through developing novel treatments for primary and metastatic cancers. I am very pleased with the progress we've made
over the past year, but am even more so looking forward to what lays ahead for CNS Pharmaceuticals."
Clinical Programs Update
Berubicin - Novel anthracycline
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. In mid-2021 the Company announced it has dosed the first
group of patients in its potentially pivotal study evaluating the efficacy of Berubicin in the treatment of adult GBM, one of the most
aggressive types of brain cancer. Further patient enrollment, randomization and dosing is currently underway as well as a robust lineup
of clinical sites located globally which are advancing toward activation and enrollment.
The FDA granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the FDA to expedite
the development and review process. As previously announced, the Company also received Orphan Drug Designation from the FDA which may
provide seven years of marketing exclusivity upon approval of an NDA.
For more information about the potentially pivotal
Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.
WP1244 Portfolio - Novel class of DNA-binding
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. The Company's development work has produced a new mesylate salt of WP1244, now identified
as WP1874. The enhanced solubility of this salt may increase its ability to be formulated for use in an IV infusion, while maintaining
similar potency and toxicity characteristics. Going forward, WP1874 will be the primary focus in our development efforts of the WP1244
portfolio. CNS Pharmaceuticals is also evaluating the use of WP1244/WP1874 in the treatment of other primary brain and central nervous
system cancers, as well as cancers metastatic to the brain including pancreatic, ovarian, and lymphomas.
Summary of Financial Results for the Full Year
The net loss for the year ended December 31, 2021
was approximately $14.0 million compared to approximately $9.5 million for the comparable period in 2020. The change in net loss is attributable
to increased personnel and activity associated with preparing for and commencing the Company's potentially pivotal clinical trial of Berubicin
for recurrent glioblastoma multiforme in 2021. The Company reported research and development expenses of $9.3 million for the year ended
December 31, 2021 compared to approximately $5.1 million for the comparable period in 2020. The expenses incurred during the period were
related to drug manufacturing and labor related to the preparation for and commencement of the Company's potentially pivotal Berubicin
study. General and administrative expense was approximately $4.7 million for the year ended December 31, 2021 compared to approximately
$4.4 million for the comparable period in 2020.
As of December 31, 2021, the Company had cash
of approximately $5.0 million and working capital of approximately $5.3 million. In early January 2022, the Company completed an offering
of common stock and warrants for gross proceeds of $11.5 million. Our current expectation is that our 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
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals a clinical-stage pharmaceutical
company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central
nervous system. The Company's lead drug 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
including glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.
Additionally, the Company is advancing the development
of its WP1244/WP1874 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 also evaluating the use of WP1244/WP1874 in the treatment of
other primary brain and central nervous system cancers, as well as cancers metastatic to the brain including pancreatic, ovarian, and
For more information, please visit www.CNSPharma.com,
and connect with the Company on Twitter, Facebook, and LinkedIn.
Forward-Looking Statements
of the statements in this press 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's cash runway
to extend into the first quarter of 2023; the CNS's ability to expand its potentially pivotal study to evaluate efficacy
of Berubicin in the treatment of adult GBM into additional countries; the timing of the interim analysis of the trial; CNS's ability
to complete enrollment in potentially pivotal clinical trial for GBM; and CNS's ability to file an IND for WP1244/WP1874 in 2023.
These statements relate to future events, future expectations, plans and prospects. Although CNS believes 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 Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and
Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the
SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update
any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect
the occurrence of unanticipated events.
Investor Relations Contact