Delaware
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001-38599
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82-3827296
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(State or Other Jurisdiction of Incorporation or Organization)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock, par value $0.001 per share
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AQST
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Nasdaq Global Market
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Item 7.01 |
Regulation FD Disclosure.
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Item 9.01 |
Financial Statements and Exhibits
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(d) |
Exhibits.
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Exhibit Number
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Description
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The Q&A published in The Fly on July 2, 2020.
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Dated: July 2, 2020
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Aquestive Therapeutics, Inc.
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By:
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/s/ John T. Maxwell
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Name: John T. Maxwell
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Title: Chief Financial Officer
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1. |
Last month, the company said it plans to advance its strategy to monetize the anticipated royalties associated with Sunovion Pharmaceuticals' apomorphine sublingual film APL-130277, which received FDA approval to
treat motor fluctuations experienced by people living with Parkinson's disease. Is the company still pursuing this? How much do you expect to receive from the monetization and can we still expect this royalty stream to extend the capital
runway into 2021?
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2. |
Aquestive had said that it expects to submit the IND application for AQST-108 this month and to commence PK clinical trials later this year. Does this timeline remain the same? Or has the COVID-19 pandemic
impacted the timeline?
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3. |
Can you also provide an update on the NDA for Libervant, which has a September 27 PDUFA goal date? Is everything going as expected?
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4. |
Aside from what we discussed and looking out over the remainder of the year, what do you see as the company’s most important event or product release?
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Aquestive has a proven track record of success in developing and manufacturing differentiated therapeutics with PharmFilm technology. We have five FDA approved therapeutics, both licensed and proprietary products.
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We launched our first self-commercialized proprietary product, Sympazan, for the treatment of Lennox-Gastaut Syndrome in December 2018. Sympazan continues to grow and penetrate the market in which many prescribers will also be prescribers
of Libervant when it is approved.
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We continue to advance our late-stage pipeline of therapeutics for complex conditions. Libervant is the most advanced candidate in our pipeline, and, while there can be no assurances as to the decision the FDA may make, we hope to see it
approved in September.
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AQST-108, which could be the “first of its kind” oral version of epinephrine, will continue on its 505(b)(2) clinical and regulatory pathway following our recent IND filing with the FDA. We expect PK trials to begin later this year.
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5. |
Is there any misconception about your company that you would like to correct?
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