August 7, 2022

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Aquestive Therapeutics Announces Departure of Main Fiscal Officer and Appointment of …

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WARREN, N.J., Dec. 16, 2020 (World NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company centered on establishing and commercializing differentiated products and solutions that deal with patients’ unmet needs and remedy therapeutic challenges, these days introduced that John Maxwell, Senior Vice President, Main Economic Officer (CFO) of the Company, has supplied his intent to resign his positions with the Corporation to go after other interests. Present plans connect with for Mr. Maxwell to keep on to provide as CFO of the Organization until eventually his departure, which currently is anticipated at yr stop. Mr. Ernie Toth, a seasoned money executive most a short while ago with EHE Wellbeing as Main Money Officer, will assume the function of CFO on an interim basis upon Mr. Maxwell’s departure.

“We have created meaningful development in our business enterprise since John joined the Enterprise in January 2017,” stated Keith J. Kendall, President and Main Executive Officer of Aquestive. “John has been a valuable portion of the ongoing progress of the Company. We thank him for his contributions, primarily in shepherding our endeavours to come to be a public organization and shut several essential money markets transactions. The administration staff and board of directors of Aquestive joins me in wishing him properly in his long term small business pursuits. We foresee effecting a very clean transition in excess of the following couple of months and are pleased to welcome Mr. Toth as the new interim CFO to our crew,” concluded Mr. Kendall.

“I have enjoyed my time with Aquestive Therapeutics,” explained Mr. Maxwell. “Upon arrival, my speedy objective was to assistance evolve the capitalization of the Business. Aquestive was in the midst of its transformation into a industrial proprietary pharmaceutical company. Obtaining completed this crucial purpose, I believe that the Organization is properly positioned for foreseeable future advancement and I believe that in the power of the Aquestive company. I wish the workforce all the ideal for its ongoing achievement.”

The Organization also noted that Mr. Maxwell’s departure is not linked to the Company’s operations, economic reporting or controls.

2020 Outlook

The Company also introduced that there is no transform to its full year 2020 economical outlook.

About Aquestive Therapeutics
Aquestive Therapeutics is a pharmaceutical organization that applies ground breaking technological know-how to solve therapeutic difficulties and increase medications for clients. The Enterprise has commercialized one particular internally-developed proprietary products to date, Sympazan, has a commercial proprietary product or service pipeline targeted on the procedure of health conditions of the central nervous method, or CNS, and other unmet requirements, and is producing orally administered complicated molecules to offer alternate options to invasively administered conventional of treatment therapies. The Business also collaborates with other pharmaceutical providers to provide new molecules to market place applying proprietary, most effective-in-course systems, like PharmFilm®, and has confirmed capabilities for drug enhancement and commercialization.

Ahead-Seeking Assertion
This push launch contains ahead-looking statements in the this means of the Personal Securities Litigation Reform Act of 1995. Phrases such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the unfavorable of people conditions, and related expressions, are intended to detect forward-searching statements. These forward-looking statements contain, but are not limited to, statements regarding therapeutic gains and designs and aims for regulatory approvals of AQST-108 and Libervant means to tackle the concerns discovered in the FDA’s Full Response Letter dated September 25, 2020 with regards to the New Drug Application for Libervant and acquire Food and drug administration acceptance of Libervant for U.S. marketplace accessibility skill to obtain Fda approval and advance AQST-108, Libervant and our other merchandise candidates to the sector about our development and long run economical and functioning results and fiscal position regulatory acceptance and pathway scientific demo timing and options our and our competitors’ orphan drug approval and resulting drug exclusivity for our items or items of our competitors short-time period and extended-term liquidity and money specifications, hard cash funding and funds burn up business enterprise tactics, sector possibilities, and other statements that are not historic points. These ahead-on the lookout statements are also issue to the unsure affect of the COVID-19 global pandemic on our enterprise like with respect to our scientific trials like web page initiation, individual enrollment and timing and adequacy of scientific trials on regulatory submissions and regulatory opinions and approvals of our product or service candidates pharmaceutical component and other raw components supply chain, manufacture, and distribution sale of and demand for our products our liquidity and availability of cash sources consumer desire for our merchandise and solutions customers’ skill to spend for goods and services and ongoing availability of an ideal labor force and proficient industry experts. Presented these uncertainties, the Enterprise is unable to deliver assurance that operations can be managed as prepared prior to the COVID-19 pandemic. These forward-hunting statements are centered on our latest anticipations and beliefs and are topic to a quantity of dangers and uncertainties that could lead to true success to differ materially from these explained in the forward-seeking statements. These kinds of threats and uncertainties involve, but are not minimal to, hazards associated with the Company’s development operate, such as any delays or improvements to the timing, expense and accomplishment of our products growth actions and medical trials and designs threat of delays in Food and drug administration acceptance of Libervant and our other drug candidates or failure to receive acceptance hazard of our capacity to exhibit to the Fda “clinical superiority” inside of the this means of the Fda restrictions of our drug applicant Libervant relative to Food and drug administration-accepted diazepam rectal gel and nasal spray goods which includes by establishing a significant contribution to client treatment inside the this means of Food and drug administration regulations relative to the authorised items as effectively as challenges similar to other potential pathways or positions which are or might in the future be innovative to the Food and drug administration to defeat the seven 12 months orphan drug exclusivity granted by the Food and drug administration for the approved nasal spray product of a competitor in the U.S. and there can be no assurance that we will be productive chance that a competitor obtains Food and drug administration orphan drug exclusivity for a product or service with the exact same energetic moiety as any of our other drug goods for which we are seeking Fda approval and that these types of previously authorised competitor orphan drug blocks these other products candidates in the U.S. for seven several years for the similar indication hazard inherent in commercializing a new product or service (such as know-how pitfalls, money pitfalls, marketplace challenges and implementation risks and regulatory constraints) risks for consummating the monetization transaction for KYNMOBI and other dangers and uncertainties regarding the royalty and other revenue stream of KYNMOBI, achievement of royalty targets all over the world or in any jurisdiction and specified other industrial targets needed for contingent payments under the monetization transaction, and of sufficiency of net proceeds of the monetization transaction just after pleasure of and compliance with 12.5% Senior Notes obligations, as applicable, and for funding the Company’s operations possibility of improvement of our profits and advertising and marketing capabilities threat of legal prices involved with and the final result of our patent litigation difficult third bash at danger generic sale of our proprietary items chance of adequate funds and income means, which includes obtain to available debt and equity financing and revenues from functions, to satisfy all of our short-expression and extended phrase funds specifications and other hard cash demands, at the situations and in the amounts desired danger of failure to fulfill all monetary and other personal debt covenants and of any default threat associated to governing administration claims versus Indivior for which we license, manufacture and offer Suboxone® and which accounts for the sizeable part of our existing functioning revenues risk related with Indivior’s cessation of production of its authorized generic buprenorphine naloxone film product or service, which include the impression from loss of orders for the approved generic item and hazard of eroding sector share for Suboxone and threat of sunsetting product hazards relevant to the outsourcing of specific marketing and advertising and other operational and employees features to third parties risk of the level and degree of current market acceptance of our item and solution candidates the success of any competing merchandise, which include generics threat of the dimension and development of our solution marketplaces hazards of compliance with all Fda and other governmental and purchaser needs for our production facilities hazards associated with intellectual residence legal rights and infringement claims relating to the Company’s goods hazard of surprising patent developments the impact of current and future legislation and regulatory provisions on products exclusivity laws or regulatory steps influencing pharmaceutical product pricing, reimbursement or accessibility statements and threats that may perhaps occur concerning the basic safety or efficacy of the Company’s solutions and product or service candidates chance of loss of substantial buyers risks connected to lawful proceedings, like patent infringement, investigative and antitrust litigation issues modifications in governing administration guidelines and rules hazard of product or service recalls and withdrawals uncertainties associated to typical financial, political, enterprise, field, regulatory and market circumstances and other unconventional products and other uncertainties affecting the Corporation explained in the “Risk Factors” portion and in other sections integrated in our Once-a-year Report on Form 10 K, in our Quarterly Reports on Form 10-Q, and in our Existing Studies on Sort 8-K submitted with the Securities Exchange Commission (SEC). Specified those uncertainties, you really should not position undue reliance on these ahead-wanting statements, which talk only as of the day manufactured. All subsequent ahead-wanting statements attributable to us or any person performing on our behalf are expressly capable in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements or outlook or assistance right after the date of this push release whether as a end result of new information and facts, long run activities or if not, other than as may well be necessary by relevant law.

PharmFilm®, Sympazan® and the Aquestive logo are registered logos of Aquestive Therapeutics, Inc. All other registered logos referenced herein are the residence of their respective proprietors.

Investor Inquiries:

Westwicke, an ICR Company
Stephanie Carrington
[email protected]
646-277-1282

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