Aquestive Therapeutics to Report To start with Quarter 2021 Money Success and Latest Business Highlights on May possibly 4 and Host Meeting Call on May 5 at 8:00 a.m. ET
WARREN, N.J., April 21, 2021 (Globe NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical organization centered on producing and commercializing differentiated products that deal with patients’ unmet desires and address therapeutic troubles, announced nowadays that it will report outcomes for 1st quarter finished March 31, 2021 and deliver an update on current developments in its company after marketplace near on Tuesday, May well 4, 2021.
Management will host a conference phone for traders at 8:00 a.m. ET on Wednesday, May well 5, 2021. The meeting connect with can be accessed by dialing (866) 417-5886 from the U.S. and (409) 217-8235 internationally, followed by the convention ID: 4455107.
There will also be a simultaneous, are living webcast accessible on the Investors segment of the Company’s web-site at https://traders.aquestive.com/functions-and-displays. The webcast will be archived for 30 days.
About Aquestive Therapeutics
Aquestive Therapeutics is a pharmaceutical enterprise that applies impressive engineering to resolve therapeutic troubles and enhance medicines for clients. The Enterprise has commercialized a single internally-produced proprietary item to date, Sympazan® (clobazam) oral movie, has a professional proprietary products pipeline targeted on the therapy of disorders of the central nervous technique, or CNS, and other unmet demands, and is building orally administered intricate molecules to provide choices to invasively administered normal of treatment therapies. The Firm also collaborates with other pharmaceutical providers to carry new molecules to sector applying proprietary, most effective-in-course technologies, like PharmFilm®, and has tested abilities for drug enhancement and commercialization.
Ahead-Wanting Assertion
Selected statements in this push release consist of “forward-searching statements” inside of the that means of the Private Securities Litigation Reform Act of 1995. Terms this sort of as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the destructive of these phrases, and very similar expressions, are intended to identify ahead-seeking statements. These forward-seeking statements involve, but are not constrained to, statements with regards to the progression of Libervant™ and other product candidates by the regulatory and improvement pipeline and company tactics, market place options, and other statements that are not historical points. These forward-on the lookout statements are subject to the unsure effects of the COVID-19 worldwide pandemic on our enterprise such as with regard to our medical trials like web site initiation, patient enrollment and timing and adequacy of scientific trials on regulatory submissions and regulatory assessments and approvals of our product candidates pharmaceutical ingredient and other uncooked elements provide chain, manufacture, and distribution sale of and demand for our products our liquidity and availability of funds means customer desire for our products and providers customers’ means to pay back for products and expert services and ongoing availability of an acceptable labor pressure and expert gurus. Presented these uncertainties, the Company is unable to supply assurance that operations can be taken care of as prepared prior to the COVID-19 pandemic.
These ahead-seeking statements are primarily based on our present expectations and beliefs and are subject matter to a number of pitfalls and uncertainties that could lead to true results to vary materially from those people explained in the ahead-looking statements. These risks and uncertainties contain, but are not restricted to, risks affiliated with the Company’s growth get the job done, together with any delays or improvements to the timing, expense and accomplishment of our product advancement pursuits and clinical trials and ideas for AQST-108, AQST-109 and our other drug candidates hazard of delays in Food and drug administration approval of our drug candidates Libervant, AQST-108, AQST-109 and our other drug candidates or failure to obtain approval capability to address the considerations recognized in the FDA’s Complete Response Letter dated September 25, 2020 about the New Drug Software for Libervant threat of our means to demonstrate to the Fda “clinical superiority” inside of the meaning of the Food and drug administration polices of Libervant relative to Food and drug administration-approved diazepam rectal gel and nasal spray items such as by developing a significant contribution to affected individual treatment in the indicating of Fda polices relative to the approved goods as perfectly as threats associated to other probable pathways or positions which are or might in the foreseeable future be innovative to the Food and drug administration to defeat the 7 year orphan drug exclusivity granted by the Food and drug administration for the authorised nasal spray item of a competitor in the U.S. and there can be no assurance that we will be productive chance that a competitor obtains Fda orphan drug exclusivity for a products with the very same lively moiety as any of our other drug goods for which we are in search of Fda acceptance and that this kind of before accredited competitor orphan drug blocks these other solution candidates in the U.S. for 7 a long time for the exact sign threat inherent in commercializing a new products (together with technological know-how threats, fiscal dangers, current market risks and implementation dangers and regulatory restrictions) hazard of growth of our revenue and marketing abilities chance of lawful fees associated with and the end result of our patent litigation hard 3rd party at possibility generic sale of our proprietary solutions danger of ample capital and cash means, which includes obtain to accessible credit card debt and fairness funding and revenues from operations, to satisfy all of our small-time period and for a longer period term funds requirements and other money requirements, at the periods and in the quantities wanted possibility of failure to satisfy all economic and other debt covenants and of any default our and our competitors’ orphan drug approval and ensuing drug exclusivity for our products and solutions or merchandise of our opponents small-term and extensive-expression liquidity and hard cash specifications, income funding and income burn up danger linked to authorities promises versus Indivior for which we license, manufacture and provide Suboxone® and which accounts for the significant component of our current running revenues hazards connected to the outsourcing of selected advertising and marketing and other operational and personnel capabilities to 3rd functions threat of the rate and degree of current market acceptance of our products and solution candidates the achievements of any competing products and solutions, which includes generics danger of the dimensions and progress of our product or service marketplaces threats of compliance with all Food and drug administration and other governmental and consumer requirements for our manufacturing services challenges linked with intellectual property legal rights and infringement claims relating to the Firm’s solutions chance of sudden patent developments the effect of current and foreseeable future laws and regulatory provisions on product exclusivity legislation or regulatory steps affecting pharmaceutical products pricing, reimbursement or accessibility claims and threats that could crop up concerning the security or efficacy of the Company’s merchandise and products candidates possibility of decline of significant customers dangers related to lawful proceedings, which include patent infringement, investigative and antitrust litigation matters alterations in federal government legislation and polices threat of merchandise recollects and withdrawals uncertainties relevant to general financial, political, company, industry, regulatory and current market disorders and other abnormal merchandise and other uncertainties influencing the Company explained in the “Risk Factors” portion and in other sections incorporated in our Annual Report on Kind 10 K, in our Quarterly Reviews on Variety 10-Q, and in our Latest Reviews on Variety 8-K submitted with the Securities Trade Fee (SEC). Supplied all those uncertainties, you should really not location undue reliance on these ahead-hunting statements, which speak only as of the day built. All subsequent forward-looking statements attributable to us or any man or woman performing on our behalf are expressly experienced in their entirety by this cautionary statement. The Firm assumes no obligation to update forward-hunting statements or outlook or assistance soon after the day of this push release whether as a final result of new facts, future functions or usually, except as may well be required by relevant regulation.
PharmFilm®, Sympazan® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered logos referenced herein are the residence of their respective homeowners.
Trader Inquiries
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Stephanie Carrington
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