The following discussion and analysis should be read in conjunction with the
Condensed Financial Statements and Notes thereto included elsewhere in this
Quarterly Report. This discussion contains certain forward-looking statements
that involve risks and uncertainties. The Company's actual results and the
timing of certain events could differ materially from those discussed in these
forward-looking statements as a result of certain factors, including, but not
limited to, those set forth herein and elsewhere in this Quarterly Report and in
the Company's other filings with the
As used in this Management's Discussion and Analysis of Financial Condition and
Results of Operations, unless otherwise indicated, the terms "the Company",
"we", "us", "our" and similar terminology refer to
Background and Known Trends and Uncertainties
We are a pharmaceutical development company that is focused on developing and ultimately commercializing innovative therapeutics for patients with certain cancers and certain non-cancerous proliferation disorders. While we are not presently conducting research and development activities with respect to our currently in-licensed technologies and our own intellectual property as a result of pending litigations involving our company (see note 7 to the accompanying financial statements), we have explored and expect to continue to explore acquiring or licensing other innovative preclinical and clinical stage therapeutics addressing unmet needs and orphan indications beyond cancer.
Our results of operations must be viewed in light of the pending litigations involving our company and our resulting inability to conduct meaningful research, development and other activities as a result. Until such pending litigations are resolved, we will continue to be unable to progress our business. Moreover, the resolution of such litigations is highly uncertain, and therefore even if such litigations are resolved, we cannot currently predict if and how we will be able to recommence full operations.
Critical Accounting Policies
See Note 3 of the Notes to Condensed Financial Statements included in Item 1 of this Quarterly Report for a summary of significant accounting policies and information on recently issued accounting pronouncements.
Results of Operations
For the three months ended
Research and Development Expenses.
We recognized less than
General and Administrative Expenses.
We recognized approximately
For the six months ended
Research and Development Expenses.
We recognized less than
General and Administrative Expenses.
We recognized approximately
Gain on loan forgiveness.
We recognized
Liquidity and Capital Resources
We had approximately
We will consider financing for our research and development, and other corporate efforts and our working capital needs primarily through:
• proceeds from public and private financings (including most recently financing, from our majority shareholder, Mayne Pharma) and, potentially, from other strategic transactions; • royalty revenue from Mayne Pharma from sales of SUBA-Itraconazole BCCNS upon and assuming approval by FDA (after earned royalties have been applied to any royalties advanced under Third Amended SLA, although it is uncertain if and when such FDA approval will be obtained); • proceeds from the exercise of outstanding warrants previously issued in private financings (including, potentially, warrants held by our majority shareholder, Mayne Pharma); 11
--------------------------------------------------------------------------------
Table of Contents • potential partnerships with other pharmaceutical companies to assist in the supply, manufacturing and distribution of our products for which we would expect to receive upfront milestone and royalty payments; • potential licensing and joint venture arrangements with third parties, including other pharmaceutical companies where we would receive funding based on out-licensing our product; and • government or private foundation grants or loans which would be awarded to us to further develop our current and future therapies, or government payroll protection or similar programs available as a result of the novel coronavirus outbreak.
However, there is a significant risk that none of these plans will be implemented in a manner necessary to sustain our operations for beyond October of 2022, and that we will be unable to obtain additional financing when needed on commercially reasonable terms, if at all. In particular, we are presently subject to shareholder litigations (see Note 7 - Legal Proceedings in the accompanying unaudited financial statements). The existence of the Action and the Putative Class Action (as defined in such note) and the uncertainty surrounding their outcome has impeded our ability to secure additional funding and conduct normal operations, and may continue to do so for so long as the outcome of the Action and the Putative Class Action is uncertain.
If adequate funds are not available when needed, we may be required to significantly reduce or refocus operations or to obtain funds through arrangements that may require us to relinquish rights to technologies or potential markets, any of which could have a material adverse effect on us. In addition, our inability to secure additional funding in the near future could cause us to wind down or discontinue operations.
© Edgar Online, source