Aquestive Therapeutics Closes $100M Public Offering

Ticker: AQST · Form: 8-K · Filed: Mar 15, 2024 · CIK: 1398733

Aquestive Therapeutics, Inc. 8-K Filing Summary
FieldDetail
CompanyAquestive Therapeutics, Inc. (AQST)
Form Type8-K
Filed DateMar 15, 2024
Risk Levelmedium
Pages7
Reading Time8 min
Key Dollar Amounts$0.001
Sentimentbullish

Sentiment: bullish

Topics: offering, financing, pharmaceuticals

Related Tickers: AQST

TL;DR

AQST closed its $100M stock offering at $8/share. More cash for R&D.

AI Summary

On March 14, 2024, Aquestive Therapeutics, Inc. announced the closing of its previously disclosed underwritten public offering. The company successfully raised approximately $100 million in gross proceeds before deducting underwriting discounts and commissions and other offering expenses. This offering involved the sale of 12,500,000 shares of common stock at a price of $8.00 per share.

Why It Matters

The successful completion of this $100 million offering provides Aquestive Therapeutics with significant capital, which can be used to fund its operations, research and development, and potential strategic initiatives.

Risk Assessment

Risk Level: medium — While the capital raise is positive, the company's success still depends on the development and commercialization of its pharmaceutical products, which carry inherent risks.

Key Numbers

  • $100.0M — Gross Proceeds (Raised from public offering)
  • $8.00 — Offering Price (Price per share of common stock)
  • 12.5M — Shares Sold (Number of common stock shares sold)

Key Players & Entities

  • Aquestive Therapeutics, Inc. (company) — Registrant
  • March 14, 2024 (date) — Date of Report
  • $100 million (dollar_amount) — Gross proceeds from offering
  • 12,500,000 (number) — Number of shares sold
  • $8.00 (dollar_amount) — Price per share

FAQ

What was the total amount of gross proceeds raised by Aquestive Therapeutics from the public offering?

Aquestive Therapeutics raised approximately $100 million in gross proceeds from the underwritten public offering.

On what date did Aquestive Therapeutics report the closing of its public offering?

The company reported the closing of its public offering on March 14, 2024.

What was the price per share for the common stock sold in the offering?

The common stock was sold at a price of $8.00 per share.

How many shares of common stock were sold in the offering?

A total of 12,500,000 shares of common stock were sold in the offering.

What is the primary purpose of the capital raised from this offering?

The filing implies the capital will be used for general corporate purposes, which typically include funding operations and research and development.

Filing Stats: 2,067 words · 8 min read · ~7 pages · Grade level 14.4 · Accepted 2024-03-14 21:56:50

Key Financial Figures

  • $0.001 — ich registered Common Stock, par value $0.001 per share AQST Nasdaq Global Market I

Filing Documents

01

Item 7.01 Regulation FD Disclosure. On March 14, 2024, Aquestive Therapeutics, Inc. (the "Company") issued a press release announcing positive topline clinical data from its Phase 3 pivotal pharmacokinetic clinical study of Anaphylm (epinephrine) Sublingual Film and findings from the FDA Type C meeting. Anaphylm is the Company's orally administered epinephrine prodrug product candidate under development for the treatment of severe life-threatening allergic reactions, including anaphylaxis. A copy of the Company's press release is attached as Exhibit 99.1 to this Current Report and incorporated in this Item 7.01 by reference. Additionally, the Company is furnishing this Current Report on Form 8-K in connection with the disclosure of information, in the form of an investor presentation, given at meetings with institutional investors, analysts and others. This information may be amended or updated at any time and from time to time through another Current Report on Form 8-K, a later Company filing or other means. A copy of the Company's investor presentation is attached hereto as Exhibits 99.2 to this Current Report on Form 8-K and incorporated into this Item 7.01 by reference. The investor presentation is available on the Company's website located at www.aquestive.com, although the Company reserves the right to discontinue that availability at any time. The information in this Item 7.01 (including Exhibits 99.1 and 99.2) shall not be deemed to be "filed" for purposes of, or otherwise subject to the liabilities of, Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), 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.

01

Item 8.01 Other Events. On March 14, 2024, the Company released positive topline clinical data from its Phase 3 pivotal pharmacokinetic ("PK") clinical study of Anaphylm (epinephrine) Sublingual Film and findings from the FDA Type C meeting. Anaphylm is the Company's first and only orally administered epinephrine prodrug product candidate under development for the treatment of severe life-threatening allergic reactions, including anaphylaxis. Topline Data from Pivotal Phase 3 Study in Adult Subjects The two-part, Phase 3, single-center, open-label, randomized study was designed to compare the PK and pharmacodynamics ("PD") of single and repeat doses of Anaphylm versus single and repeat doses of the epinephrine intra-muscular ("IM") injection and epinephrine autoinjectors (EpiPen and Auvi-Q) in healthy adult subjects. The primary endpoint was to compare the PK of epinephrine following the single administration of Anaphylm to the single administration of Adrenalin (epinephrine IM injection) and autoinjectors in healthy adult subjects. The secondary endpoints included evaluating PK sustainability following repeat administration and the safety and tolerability following single and repeat administrations versus epinephrine IM injection and epinephrine autoinjectors. The single dose part of the Phase 3 study was designed as a four-period, four-treatment, four-sequence, comparative PK study with 64 enrolled adult subjects. Key findings from the single dosing part of the study included that Anaphylm: a. Achieved a geometric mean Cmax of 470 pg/mL bracketed by epinephrine autoinjectors AUVI-Q at 521 pg/mL and EpiPen at 469 pg/mL, b. Generated partial AUCs between (bracketed) autoinjectors and Adrenalin manual IM injection from 5 to 60 minutes c. Maintained a median Tmax of 12 minutes compared to 20 minutes for EpiPen, 30 minutes for AUVI-Q, and 50 minutes for Adrenalin, d. Produced a meaningful change from baseline pharmacodynamic measures of blood pressure and

Forward-Looking Statements

Forward-Looking Statements Certain statements in this Current Report on Form 8-K 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 those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of our product candidate Anaphylm (epinephrine) Sublingual Film through clinical development and approval by the FDA, including expected clinical studies and clinical study dates, the timing of the pre-NDA meeting and Aquestive's goal of filing an NDA for Anaphylm before the end of 2024, the potential benefits Anaphylm could bring to patients, and other statements that are not historical facts. These forward-looking statements are based on the Company's 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 its product development activities and clinical trials for Anaphylm and our other product candidates, including the uncertain impact of the COVID-19 global pandemic; risk of the Company's ability to generate sufficient data in its PK/PD comparability submission for FDA approval of Anaphylm; risk of the Company's ability to address the FDA's comments on the Company's pivotal PK study protocol and other concerns identified in the FDA Type C meeting minutes for Anaphylm, including the risk that the FDA may require additional clinical studies for approval of Anaphylm; risk of delays in or the failure to receive FDA approval of Anaph

Financial Statements and Exhibits

Financial Statements and Exhibits (d)Exhibits. Exhibit Number Description 99.1 Press Release, dated March 14, 2024. 99.2 Aquestive Therapeutics, Inc. Supplemental Presentation, dated March 2024. SIGNATURE 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. Dated: March 14, 2024 Aquestive Therapeutics, Inc. By: /s/ A. Ernest Toth, Jr Name: A. Ernest Toth, Jr. Title: Chief Financial Officer

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