The following discussion and analysis of the Company's financial condition and results of operations should be read together with our audited financial statements and the notes thereto, included in "Item 8. Financial Statements and Supplemental Data" of this Report. This discussion contains certain forward-looking statements based on the views and beliefs of our management, as well as assumptions and estimates made by our management. These statements are subject to risks and uncertainties, and are influenced by various factors. Our actual results may differ materially from those in these forward-looking statements as a result of many factors, including those set forth under "Item 1A. Risk Factors" of this Report.
Organizational Overview
Since
Critical Accounting Policies and Estimates
Basis of Presentation
Our discussion and analysis of our financial condition and results of operations
are based upon our financial statements, which have been prepared in accordance
with accounting principles generally accepted in
30 Table of Contents Accounting Basis
The Company uses the accrual basis of accounting and accounting principles
generally accepted in
Our critical accounting policies are outlined in "Note 1 - Summary of Significant Accounting Policies" to the Note to the Financial Statements, included elsewhere in this Report.
JOBS Act:
Section 107 of the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act") provides that an "emerging growth company" can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an "emerging growth company" can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. As an emerging growth company, we have elected to take advantage of the benefits of this extended transition period. Our financial statements may therefore not be comparable to those of companies that comply with such new or revised accounting standards.
Plan of Operations
Our current business plan is to commercialize leronlimab if and when it receives
approval by the FDA. Since announcements of the partial clinical hold and BLA
withdrawal, we are also seeking to acquire or in-license other pharmaceutical
products or product candidates. The Company's business plan changed
significantly and materially in
We had negative working capital of
Material Factors Impacting Our Performance
Dependence on CytoDyn in General
The Company's business plan as of the date of this Report is wholly-dependent on its Commercialization and License Agreement with CytoDyn. If CytoDyn fails to obtain, or if there are delays in obtaining, required regulatory approvals for leronlimab, the Company will not be able to commercialize that product candidate, and the ability to generate revenue and the viability of the Company in general will be materially impaired. The regulatory approval process of the FDA can be lengthy, time consuming and is inherently unpredictable, which may affect the commercial viability of our product candidate. Moreover, the Company has no approval or participation rights with respect to such regulatory approval process for leronlimab, and is therefore dependent on CytoDyn in this regard. If CytoDyn is unable to obtain regulatory approval for leronlimab, the Company's current business plan, results of operations, and financial condition would be materially and adversely affected.
Dependence on CytoDyn for Leronlimab Manufacturing
Even if leronlimab is approved by the FDA (of which no assurances can be given), the Company does not own or operate a pharmaceutical manufacturing facility, and would be unable to manufacture its own supply of leronlimab. As such, the Company will depend upon CytoDyn for the supply of leronlimab, per the terms of its Supply Agreement, as well as CytoDyn's third-party manufacturing organizations and suppliers for all commercial grade quantities of leronlimab. While the Supply Agreement contains certain customary representations, warranties and covenants, if CytoDyn fails to meet its obligations under the Supply Agreement, the Company may be unable to find a suitable replacement supplier for leronlimab of comparable quality and terms acceptable to the Company. If the Company is unable to commercialize leronlimab, its current business plan, results of operations, and financial condition would be materially and adversely affected.
Requirement to Develop Sales and Marketing Capability
If leronlimab is approved by the FDA (of which no assurances can be given), the Company's principal business will be to commercialize leronlimab in its approved indications. The Company currently has no sales and marketing personnel or infrastructure, and other than the past experience of the Company's management, the Company has no sales and distribution experience and will need to build a marketing and sales organization. The Company expects to invest significant financial and management resources to build these capabilities. To the extent leronlimab or any other product candidates for which we maintain commercial rights are approved for marketing, if the Company is unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell its approved products, the Company may not be able to market and sell any product effectively or generate product revenues.
Inflation
Over the past year, the
Results of Operations for the Year Ended
We had no revenue for the years ended
Our operating expenses for the year ended
We had a net loss of
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Liquidity and Capital Resources
The Company's cash position was
Net cash used in operating activities amounted to
Net cash used in investing activities amounted to
Net cash provided by financing activities was
We do not currently have any additional commitments or identified sources of additional capital from third parties or from our officers, directors or majority stockholders. Additional financing may not be available on favorable terms, if at all.
In the future, we may be required to seek additional capital by selling additional debt or equity securities, or otherwise be required to bring cash flows in balance when we approach a condition of cash insufficiency. The sale of additional equity or debt securities, if accomplished, may result in dilution to our then stockholders. Financing may not be available in amounts or on terms acceptable to us, or at all. In the event we are unable to raise additional funding and/or obtain revenues sufficient to support our expenses, we may be forced to curtail or abandon our business operations, and any investment in the Company could become worthless.
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