AI Earnings Predictions for Aquestive Therapeutics Inc. (AQST)

EX-99.1

2 q22026-ex991earningsrelease.htm

EX-99.1

Document

Exhibit 99.1

Aquestive Therapeutics Reports Second Quarter 2026 Financial Results

and Provides Business Update

•Successfully completed human factors validation study and pharmacokinetic study for Anaphylm™ (dibutepinephrine) sublingual film

•Remains on track to resubmit Anaphylm NDA to the FDA in Q3 2026

•Continues pre-launch medical affairs activities and payer engagement

•On track to begin ex-U.S. filings of Anaphylm in Q4 2026

•Company to host investor call on August 12, 2026, at 8:00 a.m. ET

Warren, N.J., August 11, 2026 – Aquestive Therapeutics, Inc. (NASDAQ: AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced financial results for the second quarter ended June 30, 2026, and provided a strategic business update.

“The epinephrine rescue market continues to grow and remains available for conversion from older medical device technology including autoinjectors,” said Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics. “As we bring Anaphylm to market, if approved by the FDA, we believe we can be instrumental in driving conversion in the allergist office and, ultimately, the broader market. As we prepare to resubmit our application to the FDA in the coming weeks, our full attention will be to prepare for a focused, allergist-first launch of Anaphylm as quickly as possible, if approved by the FDA. In the meantime, our medical affairs team continues to interact with the allergy community on a daily basis.”

“We also continue to expand our understanding of our AdrenaVerse epinephrine prodrug platform and the opportunity it presents,” continued Daniel Barber. “Controlling the absorption and release of epinephrine allows us to target a variety of indications, especially in dermatological indications such as atopic dermatitis. The well-documented ability of epinephrine to lower histamine release through stabilizing mast cells while also downregulating key inflammatory components of atopic dermatitis creates the potential for a compelling product profile. Although AQST-108 is still in early-stage development, we are encouraged by the emerging data and plan on continuing to advance the program as we look towards 2027.”

Anaphylm™ (dibutepinephrine) sublingual film

Anaphylm is an oral epinephrine product candidate being developed for the treatment of type I allergic reactions, including anaphylaxis. The Company believes Anaphylm has the potential to be the first and only non-invasive, orally delivered epinephrine product for the treatment of type I allergic reactions, including anaphylaxis, if approved by the U.S. Food and Drug Administration (FDA).

In the second quarter of 2026, Aquestive completed the human factors validation study and the pharmacokinetic (PK) study required to address the deficiencies identified in the Complete Response Letter (CRL) issued by the FDA dated January 30, 2026. The human factors validation study evaluated a revised packaging design, incorporating modifications to the pouch opening, instructions for use, pouch and carton labeling. The study results showed significant improvement across each deficiency identified

in the CRL. Based on preliminary data, the PK study met its primary endpoints. No administration errors were observed in the self-administration arm of the PK study. In addition, there were no serious adverse events and no events that led to study drug discontinuation. The Company reaffirms its guidance to resubmit the Anaphylm New Drug Application (NDA) in the third quarter of 2026. As previously disclosed, the CRL did not identify any chemistry, manufacturing, or controls (CMC) deficiencies, and clinical results supporting comparability to autoinjectors were not questioned by the FDA. The Company will request an expedited review upon resubmission, though no shortened or expedited review timeline can be guaranteed.

Aquestive continues to advance its global regulatory strategy for Anaphylm. The Company remains on track to submit regulatory applications in Canada by the end of 2026 and in the European Union in the first quarter of 2027. The Company expects its existing clinical data to support regulatory submissions in additional markets in 2027, including the United Kingdom.

Aquestive continues to advance commercial readiness in anticipation of a potential Anaphylm launch. The Company's Medical Affairs team is driving healthcare professional awareness, and the Company recently strengthened its Scientific Advisory Board to further support scientific exchange and education. Aquestive also maintains active partnerships with leading allergy-focused patient advocacy organizations. In parallel, the commercial team continues to refine launch execution and market access strategies. These efforts are supported by the Company's exper

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aqst-202603030001398733false00013987332026-03-032026-03-03

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): March 3, 2026

Aquestive Therapeutics, Inc. (Exact name of Registrant as specified in its charter)

Delaware001-3859982-3827296 (State or other jurisdiction of incorporation)(Commission File Number)(I.R.S. Employer Identification No.)

30 Technology Drive Warren, NJ 07059 (908) 941-1900 (Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)

Not Applicable (Former name or former address, if changed since last report)

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:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered Common Stock, par value $0.001 per shareAQSTNasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company☐

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. ☐

Item 1.01 Entry into a Material Definitive Agreement.

On March 3, 2026, Aquestive Therapeutics, Inc. (the "Company") entered into Amendment No. 1 (the "Amendment") to the Purchase and Sale Agreement (the “Purchase and Sale Agreement”), dated August 13, 2025, with funds managed by RTW Investments, LP ("RTW"). The Amendment extends the Marketing Approval Deadline from its original date to June 30, 2027. Concurrently, the Company entered into a Warrant Issuance Agreement with funds managed by RTW pursuant to which the Company agreed to issue a warrant to purchase up to 375,000 shares of the Company's common stock, par value $0.001 per share (the “Common Stock”), at an exercise price of $4.00 per share, expiring on March 3, 2029. The Company also entered into a Share Purchase Commitment Agreement with certain RTW-affiliated funds, pursuant to which such funds committed to purchase, in the aggregate, not less than $5,000,000 of Common Stock during the 90-day period following the effective date of the agreement, at prices determined in accordance with Rule 415(a)(4) under the Securities Act.

The foregoing descriptions are qualified in their entirety by reference to the full text of the agreements filed as Exhibits 4.1, 10.1, 10.2, and 10.3 hereto.

Item 2.02 Results of Operations and Financial Condition.

On March 4, 2026, Aquestive Therapeutics, Inc. issued a press release announcing its reported financial results for the quarter and fiscal year ended December 31, 2025 and providing an update on recent developments in its business. A copy of the Company’s press release and the attached financial schedules are attached as Exhibit 99.1 to this report and incorporated in this Item 2.02 by reference. The information in this Item 2.02 (including Exhibit 99.1) 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 (the "Securities Act"), or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.

Item 3.02 Unregistered Sales of Equity Securities.

The information set forth in Item 1.01 with respect to the Warrant is incorporated herein by reference. The Warrant is being issued in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended.

Item 7.01 Regulation FD Disclosure.

The Company is furnishing this Current Report on Form 8-K in connection with the disclosure of information, in the form of a investor presentation, to be given at meetings with institutional investors, analysts and others. This information may be amended or updated at any time and from