You should read the following discussion and analysis of our financial condition
and results of operations in conjunction with our condensed consolidated
financial statements and notes thereto included in this Quarterly Report on
Form 10-Q and our audited financial statements and notes thereto for the year
ended December 31, 2019 included in our Annual Report on Form 10-K filed with
the Securities and Exchange Commission, or SEC, on February 24, 2020, as amended
by our Annual Report (Amendment No. 1) on Form 10-K/A filed with the SEC on May
20, 2020 (referred to herein as our Annual Report).
In addition to historical information, this discussion and analysis contains
forward-looking statements within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended, or the Exchange Act. All statements other than
statements of historical facts contained in this Quarterly Report on Form 10-Q
are forward-looking statements. These statements are often identified by the use
of words such as "believe," "contemplate," "continue," "due," "goal,"
"objective," "plan," "seek," "target," "expect," "believe," "anticipate,"
"intend," "may," "will," "would," "could," "should," "potential," "predict,"
"project," or "estimate," and similar expressions or variations.  These
statements are based on the beliefs and assumptions of our management based on
information currently available to management. Forward-looking statements
involve known and unknown risks, uncertainties and other factors that may cause
our actual results, performance or achievements to be materially different from
any future results, performance or achievements expressed or implied by the
forward-looking statements. Except as may be required by law, we undertake no
obligation to update any forward-looking statements to reflect events or
circumstances after the date of such statements.
These forward-looking statements are subject to numerous risks, including,
without limitation, the following:
•            We will need substantial additional funding to continue our
             operating activities and make further advancements in our late-stage
             clinical development programs. As of March 31, 2020, we had an
             accumulated deficit of $226.2 million. If we are unable to raise
             capital when needed, we would be forced to delay, reduce, terminate
             or eliminate our clinical development programs, or eventual
             commercialization efforts, and/or limit our operations.


•            We have entered into and rely on, and may enter into and rely on
             other, strategic relationships for the further development and
             commercialization of our product candidates and if we are unable to
             enter into such relationships on favorable terms or at all, or if
             such relationships are unsuccessful, if disputes arise between us
             and our strategic partners or if we fail to trigger contingent
             payments under such strategic relationships, we may be unable to
             realize the potential economic benefit of those product candidates.


•            Ongoing or future product development activities, including
             preclinical studies, may not prove successful in demonstrating
             proof-of concept, or may show adverse toxicological findings, and
             even if successful may not necessarily predict that subsequent
             clinical trials will show the requisite safety and efficacy of our
             product candidates.


•            Clinical drug development involves a lengthy and expensive process
             with an uncertain outcome, and results of earlier studies and trials
             may not be predictive of future trial results.


•            Delay or termination of planned clinical trials for our product
             candidates, including as a result of disruptions caused by the
             COVID-19 pandemic, could result in unplanned expenses or
             significantly adversely impact our remaining developmental
             activities and potential commercial prospects with respect to, and
             ability to generate potential revenues from, such product
             candidates.


•            We may not be able to achieve the objectives described in the
             section entitled "Overview-Key Product Candidate Development
             Updates" and "Overview-Business Updates" below. The results of any
             further development activities may not be sufficient to support a
             new drug application, or NDA, submission for any of our product
             candidates, or regulatory approval of our product candidates.


•            The regulatory approval processes of the Food and Drug
             Administration, or FDA, are lengthy, time-consuming and inherently
             unpredictable, and if we are ultimately unable to obtain regulatory
             approval for our product candidates, our business will be
             substantially harmed.


•            We specialize solely in developing nitric oxide-based therapeutics
             to treat a range of diseases with significant unmet needs, and if we
             do not successfully achieve regulatory approval for any of our
             product candidates or successfully commercialize them, we may not be
             able to continue as a business.



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