News and research before you hear about it on CNBC et al. Claim your 1-week free trial for Street Insider Premium here.
WARREN, NJ, October 14, 2021 (GLOBE NEWSWIRE) – Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on the development and commercialization of differentiated products that meet unmet patient needs and solve therapeutic problems , today announced that it will release its results for the third quarter ended September 30, 2021 and provide an update on recent developments in its business after market close on Tuesday, November 2, 2021.
Management will host an investor conference call at 8:00 am ET on Wednesday, November 3, 2021. The conference call can be accessed by dialing (866) 417-5886 from the United States and (409) 217-8235 internationally , followed by the conference ID: 4285256.
There will also be a simultaneous live webcast available in the Investors section of the Company’s website at https://investors.aquestive.com/events-and-presentations. The webcast will be archived for 30 days.
About Aquestive TherapeuticsAquetive Therapeutics is a pharmaceutical company that applies innovative technology to solve therapeutic problems and improve medications for patients. The Company has to date marketed an exclusive product developed in-house, the oral film Sympazan® (clobazam), has a portfolio of exclusive commercial products focused on the treatment of diseases of the central nervous system, or CNS, and others. unmet needs, and is developing complex orally administered molecules to provide alternatives to standard, invasively administered therapies. The Company also collaborates with other pharmaceutical companies to commercialize new molecules using state-of-the-art proprietary technologies, such as PharmFilm®, and has proven capabilities in drug development and commercialization.
Forward-looking statementCertain statements in this press release include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe”, “anticipate”, “plan”, “expect”, “Estimate”, “” intend “,” may “,” will “or the negative of these terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding the advancement of our product candidate Libervant ™ (diazepam) Oral Film and other product candidates through the regulatory and development pipeline and business strategies, opportunities market and other statements which are not historical facts. These forward-looking statements are subject to the uncertain impact of the global COVID-19 pandemic on our business, including with respect to our clinical trials, including site launch, patient recruitment, timing and suitability. clinical trials; on regulatory submissions and regulatory reviews and approvals of our product candidates; supply chain, manufacture and distribution of pharmaceutical ingredients and other raw materials; sales and demand for our products; our liquidity and the availability of our capital resources; customer demand for our products and services; the ability of customers to pay for goods and services; and the continued availability of an appropriate workforce and skilled professionals. Given these uncertainties, the Company is unable to provide assurance that operations can be maintained as planned before the COVID-19 pandemic.
These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in forward-looking statements. These risks and uncertainties include, without limitation, risks associated with the development work of the Company, including any delay or change in the timing, cost and success of our product development and clinical trial activities; the risk of delays in the FDA approval of Libervant and our other drug candidates or of not obtaining approval; ability to address concerns identified in the FDA’s full response letter dated September 25, 2020 regarding the new drug application for Libervant; risk of our ability to demonstrate to the FDA “clinical superiority” within the meaning of Libervant’s FDA regulations for FDA-approved rectal gel and diazepam nasal spray products including establishing a major contribution to patient care at the meaning of FDA regulations relating to approved products as well as the risks associated with other pathways or potential positions that are or may in the future be advanced to the FDA to overcome the seven-year exclusivity on orphan drugs granted by the FDA approved for a competitor’s nasal spray product in the United States and there is no guarantee that we will be successful; risk that a competitor will obtain orphan drug exclusivity from the FDA for a product with the same active moiety as one of our other drugs for which we are seeking FDA approval and that competing orphan drug approved previously blocked these other product candidates in the United States for seven years for the same indication; the risk of gaining market access for other reasons; the risk inherent in bringing a new product to market (including technological risks, financial risks, market risks and implementation risks and regulatory limitations); risk of developing our sales and marketing capabilities; the risk of associated legal fees and the outcome of our patent litigation challenging the generic sale to at-risk third parties of our proprietary products; the risk of sufficient capital and cash resources, including access to available debt and equity financing and operating income, to meet all of our short- and long-term cash and other cash requirements, at the times and for the amounts required; the risk of non-compliance with all financial and other covenants and any default; the approval of our orphan drugs and that of our competitors and the resulting drug exclusivity for our or our competitor’s products; short and long term liquidity and cash requirements, cash financing and cash consumption; the risk associated with government claims against Indivior for which we license, manufacture and sell Suboxone® and which represents a substantial portion of our current operating revenues; risks associated with the outsourcing of certain marketing and other operational and personnel functions to third parties; the risk of the rate and degree of market acceptance of our products and product candidates; the success of any competing product, including generics; the risk of the size and growth of our product markets; risks of compliance with all FDA and other government and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to the Company’s products; the risk of unexpected patent developments; the impact of existing and future legislation and regulations on product exclusivity; legislation or regulatory measures affecting the pricing, reimbursement or access of pharmaceutical products; claims and risks that may arise regarding the safety or efficacy of the Company’s products and product candidates; risk of loss of important customers; risks associated with legal proceedings, including matters of patent infringement, antitrust investigation and litigation; changes in government laws and regulations; risk of product recalls and withdrawals; uncertainties related to general economic, political, commercial, industrial, regulatory and market conditions and other unusual items; and other uncertainties affecting the Company described in the “Risk Factors” section and in other sections included in our annual report on Form 10 K, in our quarterly reports on Form 10-Q and in our current reports on Form 8 -K filed with the Securities Exchange Commission (SEC). In view of these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date of their publication. All subsequent forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update any forward-looking statements, outlook or guidance after the date of this press release, whether as a result of new information, future events or otherwise, except as required by law. applicable requires it.
PharmFilm®, Sympazan® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other trademarks referenced herein are the property of their respective owners.
Investor surveys Westwicke, an ICR Company Stephanie Carrington [email protected] 646-277-1282
Source: Aquestive Therapeutics, Inc.