Full Press Release Details
This summary highlights
information contained elsewhere in this prospectus. This summary does not contain all of the information that you should consider before
deciding to invest in our securities. You should read this entire prospectus carefully, including the "Risk Factors" section
in this prospectus and under similar captions in the documents incorporated by reference into this prospectus. References in this prospectus
to "we", "us", "its", "our" or the "Company" are to CNS Pharmaceuticals, Inc.,
as appropriate to the context.
We are a clinical pharmaceutical
company organized as a Nevada corporation in July 2017 to focus on the development of anti-cancer drug candidates for the treatment of
brain and central nervous system tumors, based on intellectual property that we license under license agreements with Houston Pharmaceuticals,
Inc. ("HPI") and The University of Texas M.D. Anderson Cancer Center ("UTMDACC") and own pursuant to a collaboration
and asset purchase agreement with Reata Pharmaceuticals, Inc. ("Reata").
We believe our lead drug candidate,
Berubicin, may be a significant development in the treatment of Glioblastoma Multiforme ("Glioblastoma") and other CNS malignancies,
and if approved by the U.S. Food and Drug Administration ("FDA"), could potentially give Glioblastoma patients an important
new therapeutic alternative to the current standard of care. Glioblastomas are tumors that arise from astrocytes, which are star-shaped
cells making up the supportive tissue of the brain. These tumors are usually highly malignant (cancerous) because the cells reproduce
quickly, and they are supported by a large network of blood vessels. Berubicin is an anthracycline, which is a class of drugs that are
among the most powerful and extensively used chemotherapy drugs known. Based on limited clinical data, we believe Berubicin is the first
anthracycline that appears to cross the blood brain barrier in therapeutic concentrations targeting brain cancer cells. While our focus
is currently on the development of Berubicin, we are also in the process of attempting to secure intellectual property rights to additional
compounds that we plan to develop into drugs to treat CNS and other cancers.
Berubicin was discovered at
UTMDACC by Dr. Waldemar Priebe, our founder. Dr. Priebe served as a member of our scientific advisory board until August 2022. Through
a series of transactions, Berubicin was initially licensed to Reata. Reata initiated several Phase I clinical trials with Berubicin for
CNS malignancies, one of which was for malignant gliomas, but subsequently allowed their IND with the FDA to lapse for strategic reasons.
This required us to obtain a new IND for Berubicin before beginning further clinical trials. On December 17, 2020, we announced that our
IND application with the FDA for Berubicin for the treatment of Glioblastoma Multiforme was in effect. We initiated this trial for patient
enrollment during the second quarter of 2021 with the first patient dosed during the third quarter of 2021 to investigate the efficacy
of Berubicin in adults with Glioblastoma Multiforme who have failed first-line therapy. Correspondence between us and the FDA resulted
in modifications to our initial trial design, including designating overall survival (OS) as the primary endpoint of our current CNS-201
trial, which is a global potentially pivotal trial of Berubicin for Glioblastoma. OS is a rigorous endpoint that the FDA has recognized
as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.
The current CNS-201 trial
being conducted will evaluate the efficacy of Berubicin in patients with Glioblastoma Multiforme who have failed primary treatment for
their disease, and results will be compared to the efficacy of Lomustine, a current standard of care in this setting, with a 2 to 1 randomization
of the estimated 243 patients to Berubicin or Lomustine. Patients receiving Berubicin will be administered a 2-hour IV infusion of 7.5
mg/m2 berubicin hydrochloride daily for three consecutive days followed by 18 days off (a 21-day cycle). Lomustine is administered orally
once every six weeks. The trial will include an interim analysis that will evaluate the comparative effectiveness of these treatments,
which is an adaptive design intended to demonstrate that there are no differences in efficacy between treatments (futility analysis).
Even if Berubicin is approved, there is no assurance that patients will choose an infusion treatment, as compared to the current standard
of care, which requires oral administration. We estimate that the remaining cost of our CNS-201 trial will be approximately $20-$24 million.
We do not have manufacturing
facilities and all manufacturing activities are contracted out to third parties. Additionally, we do not have a sales organization.
On November 21, 2017, we entered
into a Collaboration and Asset Purchase Agreement with Reata (the "Reata Agreement"). Pursuant to the Reata Agreement, we
purchased all of Reata's intellectual property and development data regarding Berubicin, including all trade secrets, knowhow, confidential
information and other intellectual property rights.
On December 28, 2017, we obtained
the rights to a worldwide, exclusive royalty-bearing, license to the chemical compound commonly known as Berubicin from HPI in an agreement
we refer to as the HPI License. HPI is affiliated with Dr. Priebe. Under the HPI License we obtained the exclusive right to develop certain
chemical compounds for use in the treatment of cancer anywhere in the world. In the HPI License we agreed to pay HPI: (i) development
fees of $750,000 over a three-year period beginning November 2019; (ii) a 2% royalty on net sales; (iii) a $50,000 per year license fee;
(iv) milestone payments of $100,000 upon the commencement of a Phase II trial and $1.0 million upon the approval of an New Drug Application
("NDA") for Berubicin; and (v) 200,000 shares of our common stock. The patents we licensed from HPI expired in March 2020.
On June 10, 2020, the FDA
granted Orphan Drug Designation ("ODD") for Berubicin for the treatment of malignant gliomas. ODD from the FDA is available
for drugs targeting diseases with less than 200,000 cases per year. ODD may enable market exclusivity of 7 years from the date of approval
of a NDA in the United States. During that period the FDA generally could not approve another product containing the same drug for the
same designated indication. Orphan drug exclusivity will not bar approval of another product under certain circumstances, including if
a subsequent product with the same active ingredient for the same indication is shown to be clinically superior to the approved product
on the basis of greater efficacy or safety, or providing a major contribution to patient care, or if the company with orphan drug exclusivity
is not able to meet market demand. The ODD now constitutes our primary intellectual property protections although we are exploring if
there are other patents that could be filed related to Berubicin to extend additional protections.
On January 10, 2020, we entered
into a Patent and Technology License Agreement (the "1244 Agreement") with The Board of Regents of The University of Texas
System, an agency of the State of Texas, on behalf of the UTMDACC. Pursuant to the 1244 Agreement, we obtained a royalty-bearing, worldwide,
exclusive license to certain intellectual property rights, including patent rights, related to our portfolio of WP1244 drug technology.
In consideration, we must make payments to UTMDACC including an up-front license fee, annual maintenance fee, milestone payments and royalty
payments (including minimum annual royalties) for sales of licensed products developed under the 1244 Agreement. The term of the 1244
Agreement expires on the last to occur of: (a) the expiration of all patents subject to the 1244 Agreement, or (b) fifteen years after
execution; provided that UTMDACC has the right to terminate the 1244 Agreement in the event that we fail to meet certain commercial diligence
On May 7, 2020, pursuant to
the WP1244 portfolio license agreement described above, we entered into a Sponsored Research Agreement with UTMDACC to perform research
relating to novel anticancer agents targeting CNS malignancies. We agreed to fund approximately $1,134,000 over a two-year period. We
paid and recorded $334,000 in 2020 related to this agreement in research and development expenses in our Statements of Operations. The
remaining $800,000 was paid in 2021. The principal investigator for this agreement is Dr. Priebe. The work conducted under this Sponsored
Research Agreement has produced a new mesylate salt of WP1244 termed WP1874. We believe 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. As such, WP1874
will be the primary focus in our development efforts of the WP1244 portfolio.
On February 18, 2022, we
received a deficiency letter from the Listing Qualifications Department (the "Staff") of the Nasdaq Stock Market ("Nasdaq")
notifying us that for the last 30 consecutive business days the bid price for our common stock had closed below the minimum $1.00 per
share requirement for continued inclusion on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the "Bid Price
In accordance with Nasdaq
Listing Rule 5810(c)(3)(A) (the "Compliance Period Rule"), we were provided an initial period of 180 calendar days to regain
compliance with the Bid Price Rule. We requested an additional 180 days in which to regain compliance, including by effecting a reverse
stock split, if necessary, and, on August 18, 2022, we received notice from Nasdaq informing us that we had been granted an additional
180-day period, or until February 13, 2023, to regain compliance with the minimum bid price requirement. If we do not regain compliance
with the Bid Price Rule by February 13, 2023, the Staff will provide written notification to us that our common stock will be delisted.
We would then be entitled to appeal the Staff's determination to a NASDAQ Hearings Panel and request a hearing.
On August 26, 2022, we announced
the results of our 2022 Annual Meeting of Stockholders. At the annual meeting, our stockholders approved an amendment to our amended and
restated articles of incorporation to effect a reverse stock split of the outstanding shares of our common stock, at a split ratio of
between 1-for-2 and 1-for-30 as determined by our Board of Directors in their sole discretion, prior to the one-year anniversary of the
Our principal executive offices
are located at 2100 West Loop South, Suite 900, Houston, TX 77027. Our website address is www.cnspharma.com. The information on or accessible
through our website is not part of this prospectus.