SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q and other written and oral statements we make from time to time contain certain "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the "Exchange Act"). You can identify these forward-looking statements by the fact they use words such as "could," "expect," "anticipate," "estimate," "target," "may," "project," "guidance," "intend," "plan," "believe," "will," "potential," "opportunity," "future" and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. You can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. These statements relate to, among other things, our business strategy, our research and development, our product development efforts, our ability to commercialize our product candidates, the activities of our licensees, our prospects for initiating partnerships or collaborations, the timing of the introduction of products, the effect of new accounting pronouncements, uncertainty regarding our future operating results and our profitability, anticipated sources of funds as well as our plans, objectives, expectations, and intentions.
We have included more detailed descriptions of these risks and uncertainties and other risks and uncertainties applicable to our business that we believe could cause actual results to differ materially from any forward-looking statements in Part II-Item 1A "Risk Factors" of this Quarterly Report on Form 10-Q. We encourage you to read those descriptions carefully. Although we believe we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved. We caution investors not to place significant reliance on forward-looking statements contained in this document; such statements need to be evaluated in light of all the information contained in this document. Furthermore, the statements speak only as of the date of this document, and we undertake no obligation to update or revise these statements.
The discussion and analysis of our financial condition and results of operations
are based on our financial statements, which we have prepared in accordance with
We expect to continue to incur significant expenses and minimal positive net cash flows from operations or negative net cash flows from operations for the foreseeable future, and those expenses and losses may fluctuate significantly from quarter-to-quarter and year-to-year. We anticipate that our expenses will fluctuate substantially as we:
? continue our ongoing preclinical studies, clinical trials and our product development activities for our pipeline of product candidates; ? seek regulatory approvals for any product candidates that successfully complete clinical trials; ? continue research and preclinical development and initiate clinical trials of our other product candidates; ? seek to discover and develop additional product candidates either internally or in partnership with other pharmaceutical companies; ? adapt our regulatory compliance efforts to incorporate requirements applicable to marketed products; ? maintain, expand and protect our intellectual property portfolio; and ? incur additional legal, accounting and other expenses in operating as a public company. 18
Results of Operations
We are a development stage company currently performing clinical trials to
obtain
During the three months ended
During the six months ended
Liquidity and Going Concern
We continually project anticipated cash requirements, predominantly from the
ongoing funding requirements of our neuropeptide drug development program. The
majority of these expenses relate to paying external vendors such as Contract
Research Organizations and peptide synthesizer companies. These expenses could
also include business combinations, capital expenditures, and new drug
development working capital requirements. As of
Operating activities used
Investing activities provided
Financing activities provided
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