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 common stock. You should read this entire prospectus carefully, including the "Risk Factors"
section, our historical consolidated financial statements and the notes thereto, each included elsewhere in this prospectus.
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").
drug candidate, Berubicin, if approved by the FDA, may be a significant discovery in the treatment of glioblastoma. Glioblastoma
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 chemotherapy drugs known. Based on limited
clinical data, we believe Berubicin is the first anthracycline that appears to have crossed the blood brain barrier and target
brain cancer cells. While our current focus is solely on the development of Berubicin, we are also in the process of attempting
to secure intellectual property rights in additional compounds that may be developed into drugs to treat cancers.
Berubicin was discovered
at MD Anderson by Dr. Waldemar Priebe, the founder of the Company. Through a series of transactions, Berubicin was initially licensed
to Reata. Reata conducted a Phase I clinical trial on Berubicin 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 intend
to initiate our trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with Glioblastoma Multiforme
who have failed first-line therapy. Recent correspondence between us and the FDA resulted in modifications to our previously disclosed
trial design, including designating overall survival (OS) as the primary endpoint of the study. 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.
trial 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 current standard of care, with 2 to 1 randomization of the 243 patients to Berubicin
or Lomustine. Subjects 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 (21-day cycle). Lomustine is administered orally. The trial will include an
interim analysis that will evaluate the comparative effectiveness of these treatments. The trial's adaptive design is intended
to allow this interim analysis of the data to demonstrate meaningful differences in efficacy between treatments and then to allow
an adjustment to the size of the patient population in the trial for maximum efficiency in terms of time in development. 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 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, which we refer to as the Reata Data.
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, who controls a majority of our shares.
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 the Company is exploring if there are other patents that could be filed related to Berubicin to extend
additional protections.
With the Reata Agreement
and the HPI License, we believe we have obtained all rights and intellectual property necessary to develop Berubicin. As stated
earlier, it is our plan to obtain additional intellectual property covering other compounds which, subject to the receipt of additional
financing, may be developed into drugs for brain and other cancers.
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 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 milestones.
we entered into a Development Agreement with WPD Pharmaceuticals ("WPD") (the "Development Agreement"),
a company founded by Dr. Priebe. Pursuant to the Development Agreement, WPD agreed to use its commercially reasonable efforts in
good faith to develop and commercialize certain products that WPD had previously sublicensed, solely in the field of pharmaceutical
drug products for the treatment of any viral infection in humans, with a goal of eventual approval of in certain territories consisting
of: Poland, Estonia, Latvia, Lithuania, Belarus, Ukraine, Romania, Armenia, Azerbaijan, Georgia, Slovakia, Czech Republic, Hungary,
Uzbekistan, Kazakhstan, Greece, Austria, Russia, Netherlands, Turkey, Belgium, Switzerland, Sweden, Portugal, Norway, Denmark,
Ireland, Finland, Luxembourg, Iceland. Pursuant to the Development Agreement, we agreed to pay WPD the following payments: (i)
an upfront payment of $225,000 to WPD (paid in April 2020); and (ii) within thirty days of the verified achievement of the Phase
II Milestone, (such verification shall be conducted by an independent third party mutually acceptable to the parties hereto), we
will make a payment of $775,000 to WPD. WPD agreed to pay us a development fee of 50% of the net sales for any products in the
above territories; provided that Poland shall not be included as a territory after WPD receives marketing approval for a product
in one-half of the countries included in the agreed upon territories or upon the payment by WPD to us of development fees of $1.0
million. The term of the Development Agreement will expire on the expiration of the sublicense pursuant to which WPD has originally
sublicensed the products, which will occur upon the expiration of the patents subject to the sublicense agreement, the earliest
of which expires in 2024.
On May 7, 2020, pursuant
to the WP1244 Portfolio license agreement described above, the Company entered into a Sponsored Research Agreement with UTMDACC
to perform research relating to novel anticancer agents targeting CNS malignancies. The Company agreed to fund approximately $1,134,000
over a two-year period. The Company will pay and record $734,000 in 2020 related to this agreement in research and development
expenses in the Company's Statements of Operations. The remainder will be paid and recorded in 2021. The principal investigator
for this agreement is Dr. Priebe. As of September 30, 2020, the Company has paid $334,000 in research and development expenses
Securities and Exchange Commission ("SEC") announced a temporary suspension of trading in our securities due to statements
made by us and others in press releases issued between March 23, 2020 and April 13, 2020 concerning our business, including the
status of development of a drug candidate labeled WP1122, the status of testing WP1122's impact on COVID-19, and the ability to
expedite regulatory approval of any such treatment. Pursuant to the suspension order, the trading halt was initiated at 9:30 a.m.
EDT on May 4, 2020 and terminated at 11:59 p.m. EDT on May 15, 2020. Commencing May 18, 2020, the Nasdaq Stock Market placed a
halt on the trading of our common stock pending the receipt of additional information. This halt was lifted on May 28, 2020. We
believe in the accuracy and adequacy of our public disclosures, but can provide no assurances that we will not encounter future
similar actions, which may adversely affect the holders of our common stock. Since the trading halt was lifted, we have not received