On May 21, 2019, Adamis
Pharmaceuticals Corporation (the “Company”) issued a press release announcing that on May 20, 2019, the Company
received notice that it had been named and served as a defendant in a lawsuit filed by kaléo Inc. in the United States
District Court for the District of Delaware regarding the Company’s higher dose naloxone injection product candidate
for the treatment of opioid overdose, for which the Company has previously submitted a New Drug Application to the U.S. Food
and Drug Administration and which is being reviewed by the agency. The complaint alleges, among other things, that the
Company’s product candidate infringes patents purportedly held by kaléo relating to its naloxone auto-injector
product. Although the ultimate outcome of this matter cannot be determined with certainty, Adamis believes that its naloxone
injection product, which combines a generic formulation of naloxone with Adamis’ proprietary injection device, does not
infringe any valid and enforceable patent held by kaléo and that kaléo’s complaint is without
merit. Adamis intends to defend against kaléo claims and pursue all available legal remedies available to the
company against kaléo, and if appropriate, its outside counsel.
The Company’s press release
is filed as exhibit 99.1 to this Report.
Forward-Looking Statements
This Report on Form 8-K contains forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events
or future results of operations, including, but not limited to the following statements: the outcome of the patent infringement
lawsuit filed by kaléo; the Company’s ability to successfully enforce and defend its intellectual property rights;
the potential costs associated with the patent infringement lawsuit filed by kaléo; any future actions of the FDA arising
from the patent infringement lawsuit filed by kaléo; the impact of the patent infringement lawsuit on our business, results
of operations and financial position; the Company’s beliefs concerning drug overdoses in the United States, illicit use
of opioids in the United States, and deaths due to fentanyl and other opioids; use of naloxone to help treat opioid overdoses;
the potential for future growth in the naloxone market; the Company’s beliefs concerning the timing and outcome of the FDA’s
review of the Company’s NDA relating to its naloxone product candidate; the Company’s ability to successfully develop
its naloxone product candidate and other product candidates; and the outcome of any discussions with third parties concerning
commercialization of the product. Such forward-looking statements include those that express plans, anticipation, intent, contingencies,
goals, targets or future development and/or otherwise are not statements of historical fact. These statements are only predictions,
are not guarantees, involve known and unknown risks, uncertainties and other factors, and concern matters that could subsequently
differ materially from those described in this press release, which may cause the Company’s actual results to be materially
different from those contemplated by these forward-looking statements. There are no assurances concerning the outcome of the patent
lawsuit filed by kaléo. The lawsuit could require material financial resources and consume significant management time
to resolve, regardless of the outcome of the proceedings. The lawsuit, or an adverse outcome in the litigation, could have a material
adverse effect on our naloxone product candidate and the Company’s business, financial conditions and results of operations.
In addition, there can be no assurances that the FDA will approve the Company’s NDA relating to its naloxone product
candidate or will give final approval to the Company’s proposed brand name for the product, concerning the timing of any
such approval, that the product will be commercially successful if approved and introduced, or concerning the outcome of any discussions
with third parties concerning commercialization of the product. The FDA review process is subject to a number of uncertainties.
The FDA could request additional or different submissions or request additional data, information, materials or clinical
trials or studies, all of which could affect the timing and outcome of the review process. As a result, there can be no
assurances regarding the timing or the outcome of the FDA’s review process. In addition, forward-looking statements
concerning our anticipated future activities assume that we are able to obtain sufficient funding to support such activities and
continue our operations and planned activities. As discussed in our filings with the Securities and Exchange Commission, we may
require additional funding, and there are no assurances that such funding will be available if required. You should not place
undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it
is made, and except as may be required by applicable law, we undertake no obligation to update or release publicly the results
of any revisions to these forward-looking statements or to reflect events or circumstances arising after the date of this Report
on Form 8-K. Certain of these risks, and additional risks, uncertainties, and other factors are described in greater detail in
the Company’s filings from time to time with the Securities and Exchange Commission, including its most recent Annual Report
on Form 10-K and subsequent filings with the SEC, which the Company strongly urges you to read and consider, all of which are
available free of charge on the SEC's web site at
http://www.sec.gov
.