On March 12, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported business highlights and financial results for the three months ended December 31, 2019 and Fiscal Year 2019 (Press release, CNS Pharmaceuticals, MAR 12, 2020, View Source [SID1234555517]).

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Business highlights for the fourth quarter of 2019 and recent weeks include the following:

Selected a leading Polish institution for the Phase 1 pediatric trial with Berubicin in glioblastoma multiforme ("GBM"). In February 2020, CNS announced the selection of Children’s Memorial Health Institute, the largest pediatric hospital in Poland as the single site for this pediatric trial which is expected to commence in the second half of 2020.
Completed final Good Manufacturing Practice ("GMP") reprocessing and purity validation of the existing batch of its lead drug candidate Berubicin. In February 2020, the Company announced the final GMP reprocessing of the existing batch of Berubicin, reporting the GMP material met all specifications and analytical testing is now underway. The Company is continuing large-scale production of Berubicin and intends to utilize this supply to complete its planned Phase 2 clinical trial for patients with GBM.
Licensed a novel DNA-binding technology from The University of Texas MD Anderson Cancer Center to expand the clinical pipeline. In January 2020, CNS entered into a licensing agreement with MD Anderson, granting the Company rights to develop and commercialize WP1244, a new class of DNA-binding agent designed to cross the blood-brain barrier for the potential treatment of primary and metastatic brain cancers. WP1244 has been shown in preclinical studies to be 500-times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.
Received positive feedback from the U.S. Food and Drug Administration ("FDA") for Pre-IND (Investigational New Drug) proposal. In its December 2019 positive response to the Company’s Pre-IND request, the FDA indicated that the proposal to use a previously manufactured and currently available supply of a lyophilized drug product (i.e., Berubicin) in the Phase 2 clinical trial appears reasonable. Furthermore, the FDA noted that the requested dosage regimen for the planned Phase 2 trial with Berubicin in GBM, which will be based on the Reata Phase 1 trial, was reasonable.
Closed initial public offering ("IPO") of common stock. The Company closed its IPO of 2,125,000 shares of common stock at an offering price of $4.00 per share on November 13, 2019 and an additional 318,750 shares pursuant to the exercise in full of the underwriters’ over-allotment option sold at the IPO price of $4.00 per share on November 20, 2019. Gross proceeds from the offering, including the exercise of the underwriters’ over-allotment option, were $9.8 million and will be used to fund CNS’ clinical trials and for working capital.
"Since completing our IPO we are very pleased with the progress we have made toward initiating our Phase 2 clinical study of Berubicin to treat GBM, which represents a significant unmet medical need," stated John M. Climaco, Chief Executive Officer of CNS Pharmaceuticals. "We believe Berubicin has the ability to cross the blood-brain barrier with positive responses in these types of tumors, as demonstrated in the Phase 1 study conducted by Reata. In the second half of this year, we look forward to initiating our Phase 2 clinical study in adults in the U.S., as well as two studies conducted in Poland by our sub-license partner, WPD Pharmaceuticals, including a Phase 2 study in adults which will mirror our U.S.-based study, and a first-ever Phase 1 study in children. In addition, we plan to perform further preclinical studies for our recently licensed WP1244 drug candidate, a novel and potent DNA binding agent with high potency to inhibit tumor cell proliferation."

Fourth Quarter Financial Results

General and administrative expense was $1.0 million for the fourth quarter of 2019, compared with $0.2 million for the prior-year period. The increase is largely attributable to the expanded corporate infrastructure implemented in order to advance the Company’s clinical development program following its IPO.

Research and development expense for the fourth quarter of 2019 was $1.5 million, compared with $0 for the fourth quarter of 2018. The expense in the quarter was largely related to the cost of reprocessing and validating the existing batch of Berubicin needed for the commencement of the Phase 2 clinical trial, as well as starting the production of a new batch of the drug necessary for the contemplated clinical trials, both in the U.S. and in Poland.

The net change in cash in the fourth quarter of 2019 was $6.3 million. As of December 31, 2019, CNS had cash and cash equivalents of $7.2 million, which includes $8.8 million in net proceeds from our IPO.

Conference Call

CNS senior management will provide a business update in a conference call and live audio webcast beginning at 4:30 p.m. Eastern time today, March 12, 2020. The conference call dial-in and webcast information is as follows:

DOMESTIC DIAL-IN:

(844) 535-4071

INTERNATIONAL DIAL-IN:

(706) 679-2458

PASSCODE:

1254059

WEBCAST:

CNS Business Update Conference Call.

For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 1254059. The replay can be accessed for a period of time on the CNS website at CNS Business Update Conference Call.