Aquestive Therapeutics, Inc. A – GuruFocus.com
WARREN, NJ, June 08, 2022 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (AQST), a pharmaceutical company advancing medicines to solve patient problems with current standards of care and deliver transformative products to improve their lives , announced today that it has closed its previously announced registered direct offer with a single healthcare-focused institutional investor and certain of the company’s executives, to purchase 8,850,000 common shares (or their common stock equivalents) and warrants to purchase up to an aggregate of 8,850,000 common shares at a purchase price per share (and accompanying warrant) of $0.96 for the institutional investor and 1. $09 for Company Officers for gross proceeds of approximately $8.5 million. The warrants have a term of five years, are exercisable six months from the date of issue and have an exercise price of $0.96 per share.
“We are delighted to welcome a significant new shareholder to the company,” said Daniel Barber, President and CEO of Aquestive Therapeutics. “Given the current market environment, we will continue to focus on generating cash through a variety of methods. These include achieving and maximizing the profitability of our business and manufacturing groups, tightly manage business expenses and continue our licensing activities.We remain focused on the FDA review of Libervant and the ongoing clinical development of our oral epinephrine film candidate, AQST-109. strategies are designed to ensure that we continue to have the resources necessary to rapidly advance our two key pipeline programs.”
AGP/Alliance Global Partners acted as sole placement agent for the offering. Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as financial advisor to the offering.
This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-254775) previously filed with the United States Securities and Exchange Commission (the “SEC”). A definitive prospectus supplement describing the terms of the proposed offering has been filed with the SEC and is available on the SEC’s website at http://www.sec.gov. Electronic copies of the Prospectus Supplement may be obtained, when available, from AGP/Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].
This press release does not constitute an offer to sell or the solicitation of an offer to buy and there will be no sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful before registration or qualification under the securities laws of such state or territory.
Aquestive Therapeutics, Inc. (AQST) is a pharmaceutical company that advances medicines to solve patient problems with today’s standards of care and deliver transformative products to improve their lives. We are developing orally administered products to deliver complex molecules, offering new alternatives to invasive and impractical standard therapies. Aquestive has five products marketed in the US market, four licensed products and one standalone proprietary product to date, the oral film Sympazan® (clobazam) for the treatment of seizures associated with Lennox-Gastaut syndrome. Our licensees market their products in the United States and around the world. The Company also collaborates with pharmaceutical companies to bring new molecules to market using advanced proprietary technologies, such as PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a proprietary late-stage product pipeline focused on treating diseases of the central nervous system, or CNS, and an early-stage pipeline for the treatment of severe allergic reactions, including anaphylaxis. For more information, visit Aquestive.com and follow us on LinkedIn.
Certain 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 form of these terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties, including, among other things, the intended use of proceeds from the registered direct offering; the uncertain impact of the global COVID-19 pandemic on our business, including with respect to our clinical trials, including site initiation, patient recruitment and the timing and adequacy of clinical trials; on regulatory submissions and regulatory reviews and approvals of our product candidates; supply chain, manufacturing and distribution of pharmaceutical ingredients and other raw materials; sale and demand for our products; our liquidity and availability of capital resources; customer demand for our products and services; the ability of customers to pay for goods and services; and the continued availability of a suitable workforce and skilled professionals. Given these uncertainties, the Company is not able to guarantee 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 the forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the Company’s development work, including any delays or changes in the timing, cost and success of our product development activities and clinical trials for AQST-109 and our other product candidates; risk of delays in FDA approval of Libervant® (diazepam) buccal film, AQST-109 and our other drug candidates or failure of FDA approval; ability to address concerns identified in the FDA’s comprehensive 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 over FDA-approved diazepam rectal gels and nasal sprays including establishing a major contribution to patient care within the meaning of the FDA regulations relating to approved products as well as the risks associated with other potential avenues or positions that are or may in the future be advanced to the FDA to overcome the seven-year orphan drug exclusivity granted by the FDA for the product nasal spray from a competitor in the United States, and there can be no assurance 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 any of our other drug products for which we are seeking FDA approval and that competing orphan drug previously approved blocks these other product candidates in the United States for seven years for the same indication; risk of obtaining market access for other reasons; the risk inherent in bringing a new product to market (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risk of developing our sales and marketing capabilities; 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 cash and other needs cash, at the times and in the amounts needed; risks related to the outsourcing of certain marketing functions and other operational and personnel management functions to third parties; risk relating to the rate and degree of market acceptance of our products and product candidates; the success of any competing product, including generics; risk related to the size and growth of our product markets; risks of compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to the Company’s products; risk of unexpected patent developments; the impact of existing and future legislation and regulations on product exclusivity; legislation or regulatory actions affecting pricing, reimbursement or access to pharmaceutical products; claims and risks that may arise regarding the safety or effectiveness of the Company’s products and product candidates; risk of losing significant customers; risks relating to legal proceedings and associated costs, including patent infringement, investigative and antitrust litigation; changes in governmental laws and regulations; risk of product recalls and withdrawals; uncertainties related to general economic, political, business, industry, regulatory and market conditions and other unusual items; and other uncertainties affecting the Company described in the “Risk Factors” and other sections included in our Annual Report on Form 10-K, our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K filed with the Securities Exchange Commission. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to us or anyone acting on our behalf are expressly qualified in their entirety by this cautionary statement. The Company undertakes 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 so requires.
PharmFilm®, Sympazan® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc.