Item 7. Management’s Discussion and Analysis
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis
of our financial condition and results of operations in conjunction with the financial statements and the related notes appearing elsewhere
in this Form 10-K. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties,
including those set forth under “Cautionary Statement About Forward-Looking Statements.” Actual results and experience could
differ materially from the anticipated results and other expectations expressed in our forward-looking statements as a result of a number
of factors, including but not limited to those discussed in this Item and in Item 1A - “Risk Factors.” Actual results and
the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including
those set forth under “Risk Factors” and elsewhere in this Form 10-K.
Overview
We are a clinical stage 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 HPI and UTMDACC and own pursuant to
a collaboration and asset purchase agreement with Reata.
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We believe our lead drug candidate, Berubicin, may
be a significant development in the treatment of Glioblastoma and other CNS malignancies, and if approved by the FDA could give Glioblastoma
patients an important new therapeutic alternative to the current standard of care. 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 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 significant 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 cancers.
Berubicin was discovered at UTMDACC by Dr. Waldemar
Priebe, the founder of the Company. 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 dosed the first patient in this trial during the third quarter of 2021. Correspondence between the Company and the FDA resulted
in modifications to our initial 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.
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, 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 NDA for Berubicin; and (v) 6,667 shares of our common stock. The patents we licensed from HPI expired in March 2020.
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 “WP1244 Agreement”) with The Board of Regents of The University of Texas System, an agency
of the State of Texas, on behalf of The University of Texas M. D. Anderson Cancer Center (“UTMDACC”). Pursuant to the WP1244
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 WP1244
Agreement. The term of the WP1244 Agreement expires on the last to occur of: (a) the expiration of all patents subject to the WP1244 Agreement,
or (b) fifteen years after execution; provided that UTMDACC has the right to terminate the WP1244 Agreement in the event that we fail
to meet certain commercial diligence milestones.
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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
paid and recorded $334,000 in 2020 related to this agreement in research and development expenses in the Company’s 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. This agreement was extended and expired
on March 31, 2023.
Results of Operations for the Year Ended December 31, 2022 Compared
to the Year Ended December 31, 2021
General and Administrative Expense
General and administrative expense was $5,967,052 for
the year ended December 31, 2022 compared to $4,680,840 for 2021. The change is attributable to an increase of approximately $1,096,000
in professional expenses, $315,000 in employee compensation, $334,000 related to the write off of deferred offering costs and $84,000
in other general and administrative expenses. These changes were offset by decreases of $502,000 in stock-based compensation and advertising
and marketing of $41,000.
Research and Development Expense
Research and development expense was $9,300,055 for
the year ended December 31, 2022 compared to $9,805,075 for 2021. The decrease in research and development expenses during the period
was mainly attributed 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 Berubicin clinical trial. Our CRO expenditures are primarily for labor related to activating selected trial
sites, managing patient enrollment processes, collecting and managing data from patient treatments throughout the trial, processing reimbursement
to the sites for patient treatment, and assisting with necessary submissions to amend the IND. CRO expenditures are expected to remain
relatively consistent with the year-to-date run-rate throughout the remainder of the trial as site activation efforts and the associated
costs thereof transition into reimbursing clinical trial sites for patient treatment costs as site and patient enrollment increases. We
expect to incur increased research and development costs in the future as we continue our clinical trial.
Interest Expense
Interest expense was $7,027 and $9,285 for the years
ended December 31, 2022 and 2021, respectively.
Net Loss
The net loss for the year ended December 31, 2022 was
$15,274,134 compared to $14,495,200 for 2021. The change in net loss is primarily attributable to decreased research and development costs.
Liquidity and Capital Resources
On December 31, 2022, we had cash of $10,055,407 and
we had working capital of $7,644,386. We have historically funded our operations from proceeds from debt and equity sales.
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In January 2022, we completed a financing with
several institutional investors for the sale of (i) 316,316 shares of common stock, (ii) pre-funded warrants to purchase up to an aggregate
of 87,193 shares of common stock and (iii) warrants to purchase up to an aggregate of 403,509 shares of common stock. The combined purchase
price of one share of common stock (or one pre-funded warrant) and accompanying common warrant was $28.50. The gross proceeds from the
private placement were approximately $11.5 million, before deducting the placement agent’s fees and other offering expenses.
In November 2022, we completed a financing with
an institutional investor for the sale of (i) 147,000 shares of common stock, (ii) pre-funded warrants to purchase up to an aggregate
of 1,742,764 shares of common stock and (iii) warrants to purchase up to an aggregate of 1,889,764 shares of common stock. The combined
purchase price of one share of common stock (or one pre-funded warrant) and accompanying common warrant was $3.175. The gross proceeds
from the offering were approximately $5.98 million, before deducting the placement agent’s fees and other offering expenses.
We believe that our cash on hand is sufficient to fund
our planned operations into, but not beyond, the third quarter of 2023.
Our plan of operations is primarily
focused on completing a clinical trial for Berubicin. We estimate that we will require additional financing of approximately $8 to $12
million to complete the Phase 2 trial for Berubicin (taking into account our cash on hand as of December 31, 2022 of approximately $10.1
million), approximately $5.0 million to support near-term WP1244/WP1874 preclinical work, plus such additional working capital to fund
our operations during the pendency of the trial. Our current expectation is that our cash on hand is sufficient to fund our operations
into the third 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.
We will need to raise additional
capital in order to meet our obligations and execute our business plan. If we are unable to raise sufficient funds, we will be required
to develop and implement an alternative plan to further extend payables, reduce overhead or scale back our business plan until sufficient
additional capital is raised to support further operations. There can be no assurance that such a plan will be successful.
Summary of Cash Flows
Cash used in operating activities
Net cash used in operating activities was $10,557,815
and $13,538,309 for the years ended December 31, 2022 and 2021, respectively, and mainly included payments made for drug development (including
the cost of our potentially pivotal trial of Berubicin), contract labor, officer compensation, marketing and professional fees to our
consultants, attorneys and accountants.
Cash used in investing activities
Net cash used in investing activities
was $4,422 and $5,748 for the years ended December 31, 2022 and 2021 and included payments for furniture and equipment.
Cash provided by financing activities
Net cash provided by financing activities was $15,613,127
and $4,509,081 for the years ended December 31, 2022 and 2021. We received net proceeds of $16,038,093 from the issuance of common
stock during the year ended December 31, 2022.
Off-balance Sheet Arrangements
As of December 31, 2022, we did not have any relationships
with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities,
established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.
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Purchase Commitments
We do not have any material commitments for capital
expenditures, although we are required to pay certain development fees to HPI as described in the section “Overview” above.
JOBS Act Accounting Election
The Jumpstart Our Business Startups Act of 2012, or
the JOBS Act, exempts an “emerging growth company” such as us from being required to comply with new or revised financial
accounting standards until private companies are required to comply with the new or revised financial accounting standards. The JOBS Act
provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging
growth companies but any such election to opt out is irrevocable. We elected not to opt out of such extended transition period which means
that when a standard is issued or revised and it has different application dates for public or private companies, we, as an emerging growth
company, can adopt the new or revised standard at the time private companies adopt the new or revised standard. This may make comparison
of our financial statements with another public company which is neither an emerging growth company nor an emerging growth company which
has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting standards
used.
Critical Accounting Policies and Estimates
The preparation of financial statements in conformity
with accounting principles generally accepted in the United States of America requires management to make estimates, assumptions and judgments
that affect the amounts reported in the financial statements, including the notes thereto. We consider critical accounting policies to
be those that require more significant judgments and estimates in the preparation of our financial statements. Management
relies on historical experience and other assumptions believed to be reasonable in making its judgment and estimates. Actual results could
differ materially from those estimates.
Management believes its application of accounting policies,
and the estimates inherently required therein, are reasonable. These accounting policies and estimates are periodically reevaluated, and
adjustments are made when facts and circumstances dictate a change.
Item 7A.
Quantitative and Qualitative Disclosure About Market Risk.
We are a smaller reporting company as defined by Rule
12b-2 of the Exchange Act and are not required to provide the information required under this item.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.