<SEC-DOCUMENT>0001140361-19-021749.txt : 20191202
<SEC-HEADER>0001140361-19-021749.hdr.sgml : 20191202
<ACCEPTANCE-DATETIME>20191202073513
ACCESSION NUMBER:		0001140361-19-021749
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20191202
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20191202
DATE AS OF CHANGE:		20191202

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Aquestive Therapeutics, Inc.
		CENTRAL INDEX KEY:			0001398733
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				208623253
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-38599
		FILM NUMBER:		191262068

	BUSINESS ADDRESS:	
		STREET 1:		30 TECHNOLOGY DRIVE
		CITY:			WARREN
		STATE:			NJ
		ZIP:			07059
		BUSINESS PHONE:		908-941-1900

	MAIL ADDRESS:	
		STREET 1:		30 TECHNOLOGY DRIVE
		CITY:			WARREN
		STATE:			NJ
		ZIP:			07059

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	MonoSol Rx, Inc.
		DATE OF NAME CHANGE:	20070507
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>form8k.htm
<DESCRIPTION>8-K
<TEXT>
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      <div style="text-align: center; color: rgb(0, 0, 0); font-size: 14pt; font-weight: bold;">UNITED STATES</div>
      <div style="text-align: center; color: rgb(0, 0, 0); font-size: 14pt; font-weight: bold;">SECURITIES AND EXCHANGE COMMISSION</div>
      <div style="text-align: center; color: rgb(0, 0, 0); font-size: 12pt; font-weight: bold;">Washington, DC 20549</div>
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      <div style="text-align: center; color: rgb(0, 0, 0); font-size: 18pt; font-weight: bold;">FORM 8-K</div>
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    <div style="background-color: #FFFFFF;"><br>
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      <div style="text-align: center; color: #000000; font-weight: bold;">CURRENT REPORT</div>
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      <div style="text-align: center; color: #000000; font-weight: bold;">PURSUANT TO SECTION 13 OR 15(d) OF THE</div>
      <div style="text-align: center; color: #000000; font-weight: bold;">SECURITIES EXCHANGE ACT OF 1934</div>
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    <div style="background-color: #FFFFFF;">
      <div style="text-align: center; color: #000000; font-weight: bold;">Date of Report (Date of earliest event reported): December 2, 2019</div>
      <hr noshade="noshade" align="center" style="height: 2px; color: #000000; background-color: #000000; text-align: center; margin-left: auto; margin-right: auto; border: none;">
      <div style="text-align: center; color: rgb(0, 0, 0); font-size: 24pt;">Aquestive Therapeutics, Inc.</div>
      <div style="text-align: center; color: #000000; font-weight: bold;">(Exact name of Registrant as specified in its charter)</div>
      <div style="text-align: center; color: #000000; font-weight: bold;">
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            <div style="text-align: center; color: #000000; font-weight: bold;">Delaware</div>
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            <div style="text-align: center; color: #000000; font-weight: bold;">001-38599</div>
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            <div style="text-align: center; color: #000000; font-weight: bold;">82-3827296</div>
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            <div style="text-align: center; color: #000000; font-weight: bold;">(State or Other Jurisdiction of Incorporation or Organization)</div>
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            <div style="text-align: center; color: #000000; font-weight: bold;">(Commission File Number)</div>
          </td>
          <td style="width: 33.3%; vertical-align: top; background-color: #FFFFFF;">
            <div style="text-align: center; color: #000000; font-weight: bold;">(I.R.S. Employer Identification No.)</div>
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      <div style="text-align: center; color: #000000; font-weight: bold;">30 Technology Drive</div>
      <div style="text-align: center; color: #000000; font-weight: bold;">Warren, NJ 07059</div>
      <div style="text-align: center; color: #000000; font-weight: bold;">(908) 941-1900</div>
      <div style="text-align: center; color: #000000; font-weight: bold;">(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant&#8217;s Principal Executive Offices)</div>
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    <div style="background-color: #FFFFFF;">
      <div style="text-align: center; color: #000000; font-weight: bold;">Not Applicable</div>
      <div style="text-align: center; color: #000000; font-weight: bold;">(Former name or former address, if changed since last report)</div>
      <div style="text-align: center; color: #000000; font-weight: bold;">
        <hr noshade="noshade" align="center" style="height: 2px; color: #000000; background-color: #000000; margin-left: auto; margin-right: auto; border: none;"> </div>
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    <div style="background-color: #FFFFFF;">
      <div style="color: #000000;">Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:</div>
      <div><br>
      </div>
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              <td style="width: auto; vertical-align: top; text-align: justify;">
                <div style="color: #000000;">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</div>
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                <div style="color: #000000;">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</div>
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              <td style="width: 27pt; vertical-align: top; color: rgb(0, 0, 0); font-family: 'Segoe UI Symbol',sans-serif;">&#9744;</td>
              <td style="width: auto; vertical-align: top; text-align: justify;">
                <div style="color: #000000;">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</div>
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              <td style="width: 27pt; vertical-align: top; color: rgb(0, 0, 0); font-family: 'Segoe UI Symbol',sans-serif;">&#9744;</td>
              <td style="width: auto; vertical-align: top; text-align: justify;">
                <div style="color: #000000;">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</div>
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    <div style="color: #000000;">Securities registered pursuant to Section 12(b) of the Act:</div>
    <div>&#160;</div>
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            <div style="text-align: center; color: #000000;">Title of each class</div>
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          <td style="width: 26.28%; vertical-align: top; border-left: #000000 2px solid; border-right: #000000 2px solid; border-top: #000000 2px solid; border-bottom: #000000 2px solid;">
            <div style="text-align: center; color: #000000;">Trading Symbol(s)</div>
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            <div style="text-align: center; color: #000000;">Name of each exchange on which registered</div>
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            <div style="text-align: center; color: #000000;">Common Stock, par value $0.001 per share</div>
          </td>
          <td style="width: 26.28%; vertical-align: top; border-left: #000000 2px solid; border-right: #000000 2px solid; border-top: #000000 2px solid; border-bottom: #000000 2px solid;">
            <div style="text-align: center; color: #000000;">AQST</div>
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            <div style="text-align: center; color: #000000;">Nasdaq Global Market</div>
          </td>
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    </table>
    <div><br>
    </div>
    <div style="background-color: #FFFFFF;">
      <div style="color: #000000;">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&#167;&#8201;230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934
        (&#167;&#8201;240.12b-2 of this chapter).</div>
      <div><br>
      </div>
      <div style="color: #000000;">Emerging growth company &#9746;</div>
      <div><br>
      </div>
      <div style="color: #000000;">If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to
        Section 13(a) of the Exchange Act. &#9744;</div>
      <div style="color: #000000;"> <br>
      </div>
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              <td style="width: 45pt; vertical-align: top; color: rgb(0, 0, 0); font-weight: bold;">Item 7.01</td>
              <td style="width: auto; vertical-align: top;">
                <div style="color: #000000; font-weight: bold;">Regulation FD Disclosure.</div>
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    <div style="background-color: #FFFFFF;">
      <div style="text-align: justify; color: #000000;">On December 2, 2019, Aquestive Therapeutics, Inc. (the &#8220;Company&#8221;) issued a press release announcing that the Company completed its rolling submission of a New Drug Application (NDA) to the U.S. Food
        and Drug Administration (FDA) for Libervant&#8482; (diazepam) Buccal Film for management of seizure clusters. A copy of such press release is attached as Exhibit 99.1 to this report and incorporated into this Item 7.01 by reference.</div>
    </div>
    <div style="background-color: #FFFFFF;">
      <div><br>
      </div>
    </div>
    <div style="background-color: #FFFFFF;">
      <div style="text-align: justify; color: #000000;">The information in this Item 7.01 (including Exhibit 99.1) is being furnished pursuant to Item 7.01 and shall not be deemed to be &#8220;filed&#8221; for purposes of Section 18 of the Securities Exchange Act of
        1934, as amended (the &#8220;Exchange Act&#8221;), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall
        be expressly set forth by specific reference in any such filing.</div>
    </div>
    <div><br>
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              <td style="width: 45pt; vertical-align: top; color: rgb(0, 0, 0); font-weight: bold;">Item 9.01</td>
              <td style="width: auto; vertical-align: top;">
                <div style="color: #000000; font-weight: bold;">Financial Statements and Exhibits</div>
              </td>
            </tr>

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    <div><br>
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    <div style="margin-left: 36pt; color: #000000;">(d) Exhibits.</div>
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              <div style="color: #000000;">Exhibit Number</div>
            </td>
            <td style="width: 1%; vertical-align: bottom;">&#160;</td>
            <td style="width: 87%; vertical-align: bottom; border-bottom: 2px solid rgb(0, 0, 0);">
              <div style="color: #000000;">Description</div>
            </td>
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            <td style="width: 12%; vertical-align: top;">&#160;</td>
            <td style="width: 1%; vertical-align: bottom;">&#160;</td>
            <td style="width: 87%; vertical-align: top;">&#160;</td>
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              <div><a href="ex99_1.htm">99.1</a></div>
            </td>
            <td style="width: 1%; vertical-align: bottom;">&#160;</td>
            <td style="width: 87%; vertical-align: top;">
              <div style="background-color: #FFFFFF;">
                <div style="text-align: justify; color: #000000;">Press Release, dated December 2, 2019, announcing the Company&#8217;s completion of its rolling submission of a New Drug Application (NDA) for Libervant&#8482; (diazepam) Buccal Film.</div>
              </div>
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      <div style="text-align: center; color: #000000; font-weight: bold;">SIGNATURE</div>
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      <div><br>
      </div>
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    <div style="background-color: #FFFFFF;">
      <div style="text-align: justify; color: #000000;">Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.</div>
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          <td style="width: 49.96%; vertical-align: top;">
            <div style="color: #000000;">Dated: December 2, 2019</div>
          </td>
          <td style="width: 50.04%; vertical-align: top;" colspan="2">
            <div style="color: #000000;">Aquestive Therapeutics, Inc.</div>
          </td>
        </tr>
        <tr>
          <td style="width: 49.96%; vertical-align: top;">&#160;</td>
          <td style="width: 3.09%; vertical-align: top;">&#160;</td>
          <td style="width: 46.96%; vertical-align: top;">&#160;</td>
        </tr>
        <tr>
          <td style="width: 49.96%; vertical-align: top;">&#160;</td>
          <td style="width: 3.09%; vertical-align: top;">
            <div style="color: #000000;">By:</div>
          </td>
          <td style="width: 46.96%; vertical-align: top; border-bottom: #000000 2px solid;">
            <div style="color: #000000;">/s/ John T. Maxwell</div>
          </td>
        </tr>
        <tr>
          <td style="width: 49.96%; vertical-align: top;">&#160;</td>
          <td style="width: 3.09%; vertical-align: top;">&#160;</td>
          <td style="width: 46.96%; vertical-align: top;">
            <div style="color: #000000;">Name: John T. Maxwell</div>
          </td>
        </tr>
        <tr>
          <td style="width: 49.96%; vertical-align: top;">&#160;</td>
          <td style="width: 3.09%; vertical-align: top;">&#160;</td>
          <td style="width: 46.96%; vertical-align: top;">
            <div style="color: #000000;">Title: Chief Financial Officer</div>
          </td>
        </tr>

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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>ex99_1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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    <div style="font-weight: bold; text-align: right;">Exhibit 99.1<br>
    </div>
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    <div style="text-align: right; font-weight: bold;"> <img src="image01.jpg"></div>
    <div style="text-align: center; font-weight: bold;"> <br>
    </div>
    <div style="text-align: center; font-weight: bold;">Aquestive Therapeutics Completes Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Libervant&#8482; (diazepam) Buccal Film for Management of Seizure Clusters</div>
    <div><br>
    </div>
    <div style="text-align: justify;">
      <div>Warren, N.J., December 2, 2019 &#8211; Aquestive Therapeutics, Inc. (NASDAQ:AQST), a specialty
        pharmaceutical company focused on developing and commercializing differentiated products that meet patients&#8217; unmet needs and solve therapeutic problems, today announced the completion, as planned, of the rolling submission of a New Drug Application
        (NDA) to the U.S. Food and Drug Administration (FDA) for its therapeutic candidate Libervant&#8482; (diazepam) Buccal Film for the management of seizure clusters.&#160; Libervant has received orphan drug designation from the FDA.</div>
    </div>
    <div><br>
    </div>
    <div style="text-align: justify;">
      <div>&#8220;We are very pleased to have completed our NDA filing for Libervant as we had committed.&#160; We look forward to sharing the results from the single dose crossover study
        at the upcoming American Epilepsy Society 2019 Annual Meeting. We believe these results confirm our dosing algorithm and satisfy the final clinical requirement requested by the FDA,&#8221; remarked Keith J. Kendall, Chief Executive Officer of Aquestive
        Therapeutics.&#160; &#8220;We believe that Libervant has the potential to be the first oral therapy approved by the FDA for the management of seizure clusters in the population of 1.2 million refractory epilepsy patients and the first diazepam based treatment
        usable by and delivering a consistent predictable dose to virtually all patients to whom it will be prescribed.&#8221;</div>
    </div>
    <div><br>
    </div>
    <div style="text-align: justify; font-weight: bold;">About Libervant</div>
    <div style="text-align: justify;">
      <div>Libervant is a buccally, or inside of the cheek, administered soluble film formulation of diazepam, a benzodiazepine intended for rapid treatment of acute uncontrolled
        seizures in selected, refractory patients with epilepsy on stable regimens of AEDs who require intermittent use of diazepam to control bouts of increased seizure activity. Aquestive is developing Libervant as an alternative to Diastat (diazepam
        rectal gel), the current standard of care rescue therapy for patients with refractory epilepsy, which as a rectal gel, is invasive, inconvenient, and difficult to administer. As a result, a large portion of the patient population does not receive
        adequate treatment or foregoes treatment altogether. It is anticipated that Libervant will enable a larger share of these patients to receive more appropriate treatment by providing consistent therapeutic dosing in a non-invasive and innovative
        treatment form for epileptic seizures.</div>
    </div>
    <div><br>
    </div>
    <div style="text-align: justify; font-weight: bold;">About Aquestive Therapeutics</div>
    <div style="text-align: justify;">Aquestive Therapeutics is a specialty pharmaceutical company that applies innovative technology to solve therapeutic problems and improve medicines for patients. Aquestive is advancing a late-stage proprietary product
      pipeline to treat CNS conditions and provide alternatives to invasively administered standard of care therapies. The Company also collaborates with other pharmaceutical companies to bring new molecules to market using proprietary, best-in-class
      technologies, like PharmFilm&#174;, and has proven capabilities for drug development and commercialization.</div>
    <div><br>
    </div>
    <div style="text-align: justify; margin-right: 3.6pt; color: #000000;">PharmFilm&#174; and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. Aquestive has received conditional acceptance of the use of the trade name Libervant,
      which is subject to final FDA review and acceptance.</div>
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    <div style="text-align: justify; font-weight: bold;">
      <div style="text-align: right;"><img src="image01.jpg"></div>
      <div><br>
      </div>
      Forward-Looking Statement</div>
    <div style="text-align: justify;">This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as &#8220;believe,&#8221; &#8220;anticipate,&#8221; &#8220;plan,&#8221; &#8220;expect,&#8221; &#8220;estimate,&#8221; &#8220;intend,&#8221; &#8220;may,&#8221;
      &#8220;will,&#8221; or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements may include, but are not limited to, statements regarding therapeutic benefits and plans and
      objectives for regulatory approval of Libervant and other product candidates; statements about our growth and future financial and operating results and financial position, ability to advance Libervant and our other product candidates to the market,
      regulatory approvals and pathways, clinical trial timing and plans, short-term and long-term liquidity and cash requirements, cash funding and cash burn, business strategies, market opportunities, and other statements that are not historical facts.</div>
    <div style="text-align: justify;"><br>
    </div>
    <div style="text-align: justify;">
      <div>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. Such risks and uncertainties include, but are not limited to, risks associated with the Company's development work, including any delays or changes to the timing,
        cost and success of our product development activities and clinical trials; risk of delays in FDA approval of Libervant and our other drug candidates or failure to receive approval; risk inherent in commercializing a new product (including
        technology risks, financial risks, market risks and implementation risks and regulatory limitations); risk that a competitor obtains orphan drug exclusivity and blocks our product for the same indication for seven years; risk of development of our
        sales and marketing capabilities; risk of legal costs associated with and the outcome of our patent litigation challenging third party at risk generic sale of our proprietary products; risk of sufficient capital and cash resources, including access
        to available debt and equity financing and revenues from operations, to satisfy all of our short-term and longer term cash requirements and other cash needs, at the times and in the amounts needed; risk of failure to satisfy all financial and other
        debt covenants and of any default; risk related to government claims against Indivior for which we license, manufacture and sell Suboxone and which accounts for the substantial part of our current operating revenues; risks associated with
        Indivior&#8217;s announcement of its intention to cease production of its authorized generic buprenorphine naloxone film product, including the impact from loss of orders for the authorized generic product and risk of eroding market share for Suboxone
        and risk of sunsetting product; risks related to the outsourcing of certain sales, marketing and other operational and staff functions to third parties; risk of the rate and degree of market acceptance of our products and product candidates; the
        success of any competing products, including generics; risk of the size and growth of our product markets; risk 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 regulatory provisions on product exclusivity; legislation or
        regulatory action affecting pharmaceutical product pricing, reimbursement or access; claims and risks that may arise regarding the safety or efficacy of the Company's products and product candidates; risk of loss of significant customers; risks
        related to legal proceedings, including patent infringement, investigative and antitrust litigation matters; 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 risks and uncertainties affecting the Company including those described in the "Risk Factors" section and in other sections included in the Company's
        Annual Report on Form 10&#8209;K&#160; filed with the SEC on March 14, 2019 and in our quarterly reports on Form 10-Q. 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 any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. The
        Company assumes no obligation to update forward-looking statements or outlook or guidance after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by applicable law.</div>
    </div>
    <div><br>
    </div>
    <div>Investor inquiries:</div>
    <div>Stephanie Carrington</div>
    <div style="color: rgb(0, 0, 0);"><u>stephanie.carrington@icrinc.com</u></div>
    <div>646-277-1282</div>
    <div><br>
    </div>
    <div>Media inquiries</div>
    <div>Mark Corbae</div>
    <div style="color: rgb(0, 0, 0);"><u>mark.corbae@icrinc.com</u></div>
    <div>203-682-8288</div>
    <div> <br>
    </div>
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