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Aquestive Therapeutics Announces Recent Business Developments and Outlines Critical 2023 Goals

Aquestive Therapeutics Announces Recent Business Developments and Outlines Critical 2023 Goals

ElectraMeccanica Vehicles Corp. (NASDAQ: SOLO) today announced its partnership with the Arizona Super Bowl Host Committee (SBHC) during an official vehicle hand-off event at the Phoenix Convention Center.

As just one part of its partnership, ElectraMeccanica presented the SBHC with ten custom-wrapped, all-electric, SOLOs for the Committee to use as courtesy vehicles during the Super Bowl during January and February.

The vehicles will help SBHC employees and volunteers to easily navigate crowded city streets and limited parking options. The vehicles will also save on fuel costs and minimize environmental impact, all of which helps the SBHC to ensure its goal of leading the greenest Super Bowl ever.

ElectraMeccanica will also support the SBHC by participating in various events throughout Arizona during the weeks leading up to the Super Bowl, including an interactive display at the Super Bowl Experience presented by Lowe’s at Hance Park, 100 Yards of Education: A STEM Playbook for Youth education event at State Farm Stadium with an anticipated attendance of more than one thousand students, and other events the week leading up to Super Bowl LVII.

“We have made a significant commitment to Arizona by recently moving our corporate headquarters and manufacturing facility to Mesa,” said Susan Docherty, CEO of ElectraMeccanica Vehicles Corp. “It is important for us to support our home state, and by so doing, to help the SBHC deliver the greenest Super Bowl ever. We want to set an example for other such events throughout America, and hopefully, around the world. Moreover, we believe it’s important for business leaders and elected officials, as well as the general public, to understand that the average person drives alone 80% of the time, in a vehicle that seats more than 4 people, which leads to a lot of unoccupied seats, and a lot of wasted energy. That’s something we are committed to help change through the design and sales of our vehicles and through the support of organizations like the SBHAquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today provided an update on recent business developments and outlined key 2023 objectives. In addition, Aquestive’s Chief Executive Officer, Daniel Barber, and Chief Financial Officer, Ernie Toth, will host investor meetings from January 9 to 11, 2023 in San Francisco, concurrent with the 41st Annual J. P. Morgan Healthcare Conference.

“In 2023, we plan to focus our resources on the following key initiatives: (1) advancing AQST-109 into a pivotal PK study, (2) continuing to work with the FDA to potentially accelerate the market access for Libervant, (3) exploring new capabilities for our manufacturing business, (4) continuing to expand our base of strategic collaborations with other companies, and (5) strengthening our balance sheet,” remarked Mr. Barber. “We are thankful for the collaborations that we have forged with a variety of global companies, including Indivior Inc., Zambon S.p.A., Otter Pharmaceuticals, LLC (a subsidiary of Assertio Holdings, Inc. [“Assertio”]), Mitsubishi Tanabe Pharma America, Inc., Atnahs Pharma UK Limited (Pharmanovia), Haisco Pharmaceutical Group Co., Ltd., and Hypera S.A. It is worth highlighting that the majority of these collaborations were entered into over the last 24 months. We look forward to securing possible additional collaborations in 2023 as we continue to prioritize our alliance strategies to bringing innovative and, in some cases, life-saving medications to patients.”

“This is a pivotal year for Aquestive as we seek to build upon our momentum from the second half of 2022. We have an experienced team that has not only driven multiple FDA approvals, but has also excelled at collaborating with leading life sciences companies. We will be focused on realizing our potential as we progress through the year,” concluded Mr. Barber.

AQST-109 (epinephrine sublingual film)

In late December 2022, Aquestive received the final minutes from the End-of-Phase 2 (EOP2) meeting with the United States Food and Drug Administration (FDA) for AQST-109 (epinephrine sublingual film) for the treatment of severe allergic reactions including anaphylaxis, which provided clarity as to the FDA’s expectations regarding key program areas. Aquestive is conducting additional analysis regarding the bracketing of PK performance of approved epinephrine products and plans to finalize its protocol for the pivotal PK trial in the first half of 2023. Aquestive anticipates conducting the pivotal PK study in the second half of 2023, and continues to plan for a potential launch in 2025, if approved by the FDA.

Libervant

The Company continues to actively pursue U.S. market access for Libervant™ (diazepam) Buccal Film. Libervant was tentatively approved by the FDA in August 2022, subject to an Orphan Drug Exclusivity block until January 2027 based on a competing product.

The Company provided the FDA with additional clinical data in September 2022 and has been informed that the FDA is reviewing this data. Furthermore, in October 2022, the Company provided the FDA with a draft protocol for a head-to-head comparative PK study of Libervant versus the competing product. This was followed by a publication of a crossover food effect PK study of diazepam nasal spray in the peer-reviewed scientific journal Epilepsia in late November 2022.

Commercial Collaborations and Manufacturing

The Company continues to anticipate strong order demand for the manufacture of Indivior’s Suboxone® Sublingual Film in 2023. In addition, the Company is prepared to support the continued growth of Hypera’s Ondif (ondansetron) Oral Film in Brazil, Zambon’s upcoming launch of riluzole oral film in Europe, and the ongoing marketing efforts of Assertio with Sympazan® (clobazam) Oral Film.

Furthermore, the Company is currently exploring possible out-licensing opportunities for Libervant in several markets, including the U.S., China, and South America. The Company plans on exploring possible out-licensing opportunities for AQST-109 outside of the United States in 2023.

In 2022, the Company completed work to expand its manufacturing capabilities to include serialization and secondary packaging. This expansion allows the Company to support its existing and possible future business collaborations more broadly. With over 90,000 square feet of GMP facilities in Indiana, the Company will continue to explore possible additional manufacturing capabilities in 2023..”

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